[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Rules and Regulations]
[Pages 2470-2757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30409]
Vol. 82
Monday,
No. 5
January 9, 2017
Part II
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Parts 1910, 1915, and 1926
Occupational Exposure to Beryllium; Final Rule
Federal Register / Vol. 82 , No. 5 / Monday, January 9, 2017 / Rules
and Regulations
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, and 1926
[Docket No. OSHA-H005C-2006-0870]
RIN 1218-AB76
Occupational Exposure to Beryllium
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Final rule.
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SUMMARY: The Occupational Safety and Health Administration (OSHA) is
amending its existing standards for occupational exposure to beryllium
and beryllium compounds. OSHA has determined that employees exposed to
beryllium at the previous permissible exposure limits face a
significant risk of material impairment to their health. The evidence
in the record for this rulemaking indicates that workers exposed to
beryllium are at increased risk of developing chronic beryllium disease
and lung cancer. This final rule establishes new permissible exposure
limits of 0.2 micrograms of beryllium per cubic meter of air (0.2
μg/m3\) as an 8-hour time-weighted average and 2.0 μg/m3\ as a
short-term exposure limit determined over a sampling period of 15
minutes. It also includes other provisions to protect employees, such
as requirements for exposure assessment, methods for controlling
exposure, respiratory protection, personal protective clothing and
equipment, housekeeping, medical surveillance, hazard communication,
and recordkeeping.
OSHA is issuing three separate standards--for general industry, for
shipyards, and for construction--in order to tailor requirements to the
circumstances found in these sectors.
DATES: Effective date: The final rule becomes effective on March 10,
2017.
Compliance dates: Compliance dates for specific provisions are set
in Sec. 1910.1024(o) for general industry, Sec. 1915.1024(o) for
shipyards, and Sec. 1926.1124(o) for construction. There are a number
of collections of information contained in this final rule (see Section
IX, OMB Review under the Paperwork Reduction Act of 1995).
Notwithstanding the general date of applicability that applies to all
other requirements contained in the final rule, affected parties do not
have to comply with the collections of information until the Department
of Labor publishes a separate document in the Federal Register
announcing the Office of Management and Budget has approved them under
the Paperwork Reduction Act.
ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates
Ann Rosenthal, Associate Solicitor of Labor for Occupational Safety and
Health, Office of the Solicitor of Labor, Room S-4004, U.S. Department
of Labor, 200 Constitution Avenue NW., Washington, DC 20210, to receive
petitions for review of the final rule.
FOR FURTHER INFORMATION CONTACT: For general information and press
inquiries, contact Frank Meilinger, Director, Office of Communications,
Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue
NW., Washington, DC 20210; telephone (202) 693-1999; email
meilinger.francis2@dol.gov.
For technical inquiries, contact William Perry or Maureen Ruskin,
Directorate of Standards and Guidance, Room N-3718, OSHA, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone (202) 693-1950.
SUPPLEMENTARY INFORMATION: The preamble to the rule on occupational
exposure to beryllium follows this outline:
I. Executive Summary
II. Pertinent Legal Authority
III. Events Leading to the Final Standards
IV. Chemical Properties and Industrial Uses
V. Health Effects
VI. Risk Assessment
VII. Significance of Risk
VIII. Summary of the Final Economic Analysis and Final Regulatory
Flexibility Analysis
IX. OMB Review Under the Paperwork Reduction Act of 1995
X. Federalism
XI. State-Plan States
XII. Unfunded Mandates Reform Act
XIII. Protecting Children From Environmental Health and Safety Risks
XIV. Environmental Impacts
XV. Consultation and Coordination With Indian Tribal Governments
XVI. Summary and Explanation of the Standards
Introduction
(a) Scope and Application
(b) Definitions
(c) Permissible Exposure Limits (PELs)
(d) Exposure Assessment
(e) Beryllium Work Areas and Regulated Areas (General Industry);
Regulated Areas (Maritime); and Competent Person (Construction)
(f) Methods of Compliance
(g) Respiratory Protection
(h) Personal Protective Clothing and Equipment
(i) Hygiene Areas and Practices
(j) Housekeeping
(k) Medical Surveillance
(l) Medical Removal
(m) Communication of Hazards
(n) Recordkeeping
(o) Dates
(p) Appendix A (General Industry)
Authority and Signature
Amendments to Standards
Citation Method
In the docket for the beryllium rulemaking, found at http://www.regulations.gov, every submission was assigned a document
identification (ID) number that consists of the docket number (OSHA-
H005C-2006-0870) followed by an additional four-digit number. For
example, the document ID number for OSHA's Preliminary Economic
Analysis and Initial Regulatory Flexibility Analysis is OSHA-H005C-
2006-0870-0426. Some document ID numbers include one or more
attachments, such as the National Institute for Occupational Safety and
Health (NIOSH) prehearing submission (see Document ID OSHA-H005C-2006-
0870-1671).
When citing exhibits in the docket, OSHA includes the term
"Document ID" followed by the last four digits of the document ID
number, the attachment number or other attachment identifier, if
applicable, page numbers (designated "p." or "Tr." for pages from a
hearing transcript). In a citation that contains two or more document
ID numbers, the document ID numbers are separated by semi-colons. In
some sections, such as Section V, Health Effects, author names and year
of study publication are included before the document ID number in a
citation, for example: (Deubner et al., 2011, Document ID 0527). Where
multiple exhibits are listed with author names and year of study
publication, document ID numbers after the first are in parentheses,
for example: (Elder et al., 2005, Document ID 1537; Carter et al., 2006
(1556); Refsnes et al., 2006 (1428)).
I. Executive Summary
This final rule establishes new permissible exposure limits (PELs)
for beryllium of 0.2 micrograms of beryllium per cubic meter of air
(0.2 μg/m3\) as an 8-hour time-weighted average (TWA) and 2.0
μg/m3\ as a short-term exposure limit (STEL) determined over a
sampling period of 15 minutes. In addition to the PELs, the rule
includes provisions to protect employees such as requirements for
exposure assessment, methods for controlling exposure, respiratory
protection, personal protective clothing and equipment, housekeeping,
medical surveillance, hazard communication, and recordkeeping. OSHA is
issuing three separate standards--for general
industry, for shipyards, and for construction--in order to tailor
requirements to the circumstances found in these sectors. There are,
however, numerous common elements in the three standards.
The final rule is based on the requirements of the Occupational
Safety and Health Act (OSH Act) and court interpretations of the Act.
For health standards issued under section 6(b)(5) of the OSH Act, OSHA
is required to promulgate a standard that reduces significant risk to
the extent that it is technologically and economically feasible to do
so. See Section II, Pertinent Legal Authority, for a full discussion of
OSH Act legal requirements.
OSHA has conducted an extensive review of the literature on adverse
health effects associated with exposure to beryllium. OSHA has also
developed estimates of the risk of beryllium-related diseases, assuming
exposure over a working lifetime, at the preceding PELs as well as at
the revised PELs and action level. Comments received on OSHA's
preliminary analysis, and the Agency's final findings, are discussed in
Section V, Health Effects, Section VI, Risk Assessment, and Section
VII, Significance of Risk. OSHA finds that employees exposed to
beryllium at the preceding PELs are at an increased risk of developing
chronic beryllium disease (CBD) and lung cancer. As discussed in
Section VII, OSHA concludes that exposure to beryllium constitutes a
significant risk of material impairment to health and that the final
rule will substantially lower that risk. The Agency considers the level
of risk remaining at the new TWA PEL to still be significant. However,
OSHA did not adopt a lower TWA PEL because the Agency could not
demonstrate technological feasibility of a lower TWA PEL. The Agency
has adopted the STEL and ancillary provisions of the rule to further
reduce the remaining significant risk.
OSHA's examination of the technological and economic feasibility of
the rule is presented in the Final Economic Analysis and Regulatory
Flexibility Analysis (FEA), and is summarized in Section VIII of this
preamble. OSHA concludes that the final PELs are technologically
feasible for all affected industries and application groups. Thus, OSHA
concludes that engineering and work practice controls will be
sufficient to reduce and maintain beryllium exposures to the new PELs
or below in most operations most of the time in the affected
industries. For those few operations within an industry or application
group where compliance with the PELs cannot be achieved even when
employers implement all feasible engineering and work practice
controls, use of respirators will be required.
OSHA developed quantitative estimates of the compliance costs of
the rule for each of the affected industry sectors. The estimated
compliance costs were compared with industry revenues and profits to
provide a screening analysis of the economic feasibility of complying
with the rule and an evaluation of the economic impacts. Industries
with unusually high costs as a percentage of revenues or profits were
further analyzed for possible economic feasibility issues. After
performing these analyses, OSHA finds that compliance with the
requirements of the rule is economically feasible in every affected
industry sector.
The final rule includes several major changes from the proposed
rule as a result of OSHA's analysis of comments and evidence received
during the comment periods and public hearings. The major changes are
summarized below and are fully discussed in Section XVI, Summary and
Explanation of the Standards. OSHA also presented a number of
regulatory alternatives in the Notice of Proposed Rulemaking (80 FR
47566, 47729-47748 (8/7/2015). Where the Agency received substantive
comments on a regulatory alternative, those comments are also discussed
in Section XVI. A full discussion of all regulatory alternatives can be
found in Chapter VIII of the Final Economic Analysis (FEA).
Scope. OSHA proposed to cover occupational exposures to beryllium
in general industry, with an exemption for articles and an exemption
for materials containing less than 0.1% beryllium by weight. OSHA has
made a final determination to cover exposures to beryllium in general
industry, shipyards, and construction under the final rule, and to
issue separate standards for each sector. The final rule also provides
an exemption for materials containing less than 0.1% beryllium by
weight only where the employer has objective data demonstrating that
employee exposure to beryllium will remain below the action level of
0.1 μg/m3\ as an 8-hour TWA under any foreseeable conditions.
Exposure Assessment. The proposed rule would have required periodic
exposure monitoring annually where employee exposures are at or above
the action level but at or below the TWA PEL; no periodic monitoring
would have been required where employee exposures exceeded the TWA PEL.
The final rule specifies that exposure monitoring must be repeated
within six months where employee exposures are at or above the action
level but at or below the TWA PEL, and within three months where
employee exposures are above the TWA PEL or STEL. The final rule also
includes provisions allowing the employer to discontinue exposure
monitoring where employee exposures fall below the action level and
STEL. In addition, the final rule includes a new provision that allows
employers to assess employee exposures using any combination of air
monitoring data and objective data sufficient to accurately
characterize airborne exposure to beryllium (i.e., the "performance
option").
Beryllium Work Areas. The proposed rule would have required the
employer to establish and maintain a beryllium work area wherever
employees are, or can reasonably be expected to be, exposed to airborne
beryllium, regardless of the level of exposure. As discussed in the
Summary and Explanation section of this preamble, OSHA has narrowed the
definition of beryllium work area in the final rule from the proposal.
The final rule now limits the requirement to work areas containing a
process or operation that can release beryllium where employees are, or
can reasonably be expected to be, exposed to airborne beryllium at any
level. The final rule expands the exposure requirement to include work
areas containing a process or operation where there is potential dermal
contact with beryllium based on comments from public health experts
that relying solely on airborne exposure omits the potential
contribution of dermal exposure to total exposure. See the Summary and
Explanation section of this preamble for a full discussion of the
relevant comments and reasons for changes from the proposed standard.
Beryllium work areas are not required under the standards for shipyards
and construction.
Respiratory Protection. OSHA has added a provision in the final
rule requiring the employer to provide a powered air-purifying
respirator (PAPR) instead of a negative pressure respirator where
respiratory protection is required by the rule and the employee
requests a PAPR, provided that the PAPR provides adequate protection.
Personal Protective Clothing and Equipment. The proposed rule would
have required use of protective clothing and equipment where employee
exposure exceeds, or can reasonably be expected to exceed the TWA PEL
or STEL; where employees' clothing or skin may become visibly
contaminated with beryllium; and where employees'
skin can reasonably be expected to be exposed to soluble beryllium
compounds. The final rule requires use of protective clothing and
equipment where employee exposure exceeds, or can reasonably be
expected to exceed the TWA PEL or STEL; or where there is a reasonable
expectation of dermal contact with beryllium.
Medical Surveillance. The exposure trigger for medical examinations
has been revised from the proposal. The proposed rule would have
required that medical examinations be offered to each employee who has
worked in a regulated area (i.e., an area where an employee's exposure
exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL)
for more than 30 days in the last 12 months. The final rule requires
that medical examinations be offered to each employee who is or is
reasonably expected to be exposed at or above the action level for more
than 30 days per year. A trigger to offer periodic medical surveillance
when recommended by the most recent written medical opinion was also
added the final rule. Under the final rule, the licensed physician
recommends continued periodic medical surveillance for employees who
are confirmed positive for sensitization or diagnosed with CBD. The
proposed rule also would have required that medical examinations be
offered annually; the final rule requires that medical examinations be
offered at least every two years.
The final medical surveillance provisions have been revised to
provide enhanced privacy for employees. The rule requires the employer
to obtain a written medical opinion from a licensed physician for
medical examinations provided under the rule but limits the information
provided to the employer to the date of the examination, a statement
that the examination has met the requirements of the standard, any
recommended limitations on the employee's use of respirators,
protective clothing, and equipment, and a statement that the results of
the exam have been explained to the employee. The proposed rule would
have required that such opinions contain additional information,
without requiring employee authorization, such as the physician's
opinion as to whether the employee has any detected medical condition
that would place the employee at increased risk of CBD from further
exposure, and any recommended limitations upon the employee's exposure
to beryllium. In the final rule, the written opinion provided to the
employer will only include recommended limitations on the employee's
exposure to beryllium, referral to a CBD diagnostic center, a
recommendation for continued periodic medical surveillance, or a
recommendation for medical removal if the employee provides written
authorization. The final rule requires a separate written medical
report provided to the employee to include this additional information,
as well as detailed information related to the employee's health.
The proposed rule would have required that the licensed physician
provide the employer with a written medical opinion within 30 days of
the examination. The final rule requires that the licensed physician
provide the employee with a written medical report and the employer
with a written medical opinion within 45 days of the examination,
including any follow-up beryllium lymphocyte proliferation test
(BeLPTs).
The final rule also adds requirements for the employer to provide
the CBD diagnostic center with the same information provided to the
physician or other licensed health care professional who administers
the medical examination, and for the CBD diagnostic center to provide
the employee with a written medical report and the employer with a
written medical opinion. Under the final standard, employees referred
to a CBD diagnostic center can choose to have future evaluations
performed there. A requirement that laboratories performing BeLPTs be
certified was also added to the final rule.
The proposed rule would have required that employers provide low
dose computed tomography (LDCT) scans to employees who met certain
exposure criteria. The final rule requires LDCT scans when recommended
by the physician or other licensed healthcare professional
administering the medical exam, after considering the employee's
history of exposure to beryllium along with other risk factors.
Dates. OSHA proposed an effective date 60 days after publication of
the rule; a date for compliance with all provisions except change rooms
and engineering controls of 90 days after the effective date; a date
for compliance with change room requirements, which was one year after
the effective date; and a date for compliance with engineering control
requirements of two years after the effective date.
OSHA has revised the proposed compliance dates. The final rule is
effective 60 days after publication. All obligations for compliance
commence one year after the effective date, with two exceptions: The
obligation for change rooms and showers commences two years after the
effective date; and the obligation for engineering controls commences
three years after the effective date.1
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1 Note that the main analysis of costs and benefits presented
in this FEA does not take into account the lag in effective dates
but, instead, assumes that the rule takes effect in Year 1. To
account for the lag in effective dates, OSHA has provided in the
sensitivity analysis in Chapter VII of the FEA an estimate of its
separate effects on costs and benefits relative to the main
analysis. This analysis, which appears in Table VII-16 of the FEA,
indicates that if employers delayed implementation of all provisions
until legally required, and no benefits occurred until all
provisions went into effect, this would decrease the estimated costs
by 3.9 percent; the estimated benefits by 8.5 percent, and the
estimated net benefits of the standard by 9.2 percent (to $442
million).
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Under the OSH Act's legal standard directing OSHA to set health
standards based on findings of significant risk of material impairment
and technological and economic feasibility, OSHA does not use cost-
benefit analysis to determine the PEL or other aspects of the rule. It
does, however, determine and analyze costs and benefits for its own
informational purposes and to meet certain Executive Order
requirements, as discussed in Section VIII, Summary of the Final
Economic Analysis and Final Regulatory Flexibility Analysis and in the
FEA. Table I-1--which is derived from material presented in Section
VIII of this preamble--provides a summary of OSHA's best estimate of
the costs and benefits of the rule using a discount rate of 3 percent.
As shown, the rule is estimated to prevent 90 fatalities and 46 new
cases of CBD annually once the full effects are realized, and the
estimated cost of the rule is $73.9 million annually. Also as shown in
Table I-1, the discounted monetized benefits of the rule are estimated
to be $560.9 annually, and the rule is estimated to generate net
benefits of approximately $487 annually; however, there is a great deal
of uncertainty in those benefits due to assumptions made about dental
workers' exposures and reductions; see Section VIII of this preamble.
As that section shows, benefits significantly exceed costs regardless
of how dental workers' exposures are treated.
Table I-1--Annualized Benefits, Costs and Net Benefits of OSHA's Final
Beryllium Standard
[3 Percent discount rate, 2015 dollars]
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Annualized Costs:
Control Costs......................................... $12,269,190
Rule Familiarization.................................. 180,158
Exposure Assessment................................... 13,748,676
Regulated Areas....................................... 884,106
Beryllium Work Areas.................................. 129,648
Medical Surveillance.................................. 7,390,958
Medical Removal....................................... 1,151,058
Written Exposure Control Plan......................... 2,339,058
Protective Work Clothing & Equipment.................. 1,985,782
Hygiene Areas and Practices........................... 2,420,584
Housekeeping.......................................... 22,763,595
Training.............................................. 8,284,531
Respirators........................................... 320,885
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Total Annualized Costs (Point Estimate)........... $73,868,230
Annual Benefits: Number of Cases Prevented:
Fatal Lung Cancers (Midpoint Estimate)................ 4
Fatal Chronic Beryllium Disease....................... 86
Beryllium-Related Mortality........................... 90
Beryllium Morbidity................................... 46
Monetized Annual Benefits (Midpoint Estimate)......... $560,873,424
Net Benefits:
Net Benefits.......................................... $487,005,194
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Sources: US DOL, OSHA, Directorate of Standards and Guidance, Office of
Regulatory Analysis.
II. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act (29 U.S.C.
651 et seq.) ("the Act" or "the OSH Act"), is "to assure so far as
possible every working man and woman in the Nation safe and healthful
working conditions and to preserve our human resources" (29 U.S.C.
651(b)). To achieve this goal Congress authorized the Secretary of
Labor ("the Secretary") "to set mandatory occupational safety and
health standards applicable to businesses affecting interstate
commerce" (29 U.S.C. 651(b)(3); see 29 U.S.C. 654(a) (requiring
employers to comply with OSHA standards), 655(a) (authorizing summary
adoption of existing consensus and federal standards within two years
of the Act's enactment), and 655(b) (authorizing promulgation,
modification or revocation of standards pursuant to notice and
comment)). The primary statutory provision relied upon by the Agency in
promulgating health standards is section 6(b)(5) of the Act; other
sections of the OSH Act, however, authorize the Occupational Safety and
Health Administration ("OSHA") to require labeling and other
appropriate forms of warning, exposure assessment, medical
examinations, and recordkeeping in its standards (29 U.S.C. 655(b)(5),
655(b)(7), 657(c)).
The Act provides that in promulgating standards dealing with toxic
materials or harmful physical agents, such as beryllium, the Secretary
"shall set the standard which most adequately assures, to the extent
feasible, on the basis of the best available evidence, that no employee
will suffer material impairment of health or functional capacity even
if such employee has regular exposure to the hazard dealt with by such
standard for the period of his working life" (29 U.S.C. 655(b)(5)).
Thus, "[w]hen Congress passed the Occupational Safety and Health Act
in 1970, it chose to place pre-eminent value on assuring employees a
safe and healthful working environment, limited only by the feasibility
of achieving such an environment" (American Textile Mfrs. Institute,
Inc. v. Donovan, 452 US 490, 541 (1981) ("Cotton Dust")).
OSHA proposed this new standard for beryllium and beryllium
compounds and conducted its rulemaking pursuant to section 6(b)(5) of
the Act ((29 U.S.C. 655(b)(5)). The preceding beryllium standard,
however, was adopted under the Secretary's authority in section 6(a) of
the OSH Act (29 U.S.C. 655(a)), to adopt national consensus and
established Federal standards within two years of the Act's enactment
(see 29 CFR 1910.1000 Table Z-1). Any rule that "differs substantially
from an existing national consensus standard" must "better effectuate
the purposes of this Act than the national consensus standard" (29
U.S.C. 655(b)(8)). Several additional legal requirements arise from the
statutory language in sections 3(8) and 6(b)(5) of the Act (29 U.S.C.
652(8), 655(b)(5)). The remainder of this section discusses these
requirements, which OSHA must consider and meet before it may
promulgate this occupational health standard regulating exposure to
beryllium and beryllium compounds.
Material Impairment of Health
Subject to the limitations discussed below, when setting standards
regulating exposure to toxic materials or harmful physical agents, the
Secretary is required to set health standards that ensure that "no
employee will suffer material impairment of health or functional
capacity. . ." (29 U.S.C. 655(b)(5)). "OSHA is not required to state
with scientific certainty or precision the exact point at which each
type of [harm] becomes a material impairment" (AFL-CIO v. OSHA, 965
F.2d 962, 975 (11th Cir. 1992)). Courts have also noted that OSHA
should consider all forms and degrees of material impairment--not just
death or serious physical harm (AFL-CIO, 965 F.2d at 975). Thus the
Agency has taken the position that "subclinical" health effects,
which may be precursors to more serious disease, can be material
impairments of health that OSHA should address when feasible (43 FR
52952, 52954 (11/14/78) (Lead Preamble)).
Significant Risk
Section 3(8) of the Act requires that workplace safety and health
standards be "reasonably necessary or appropriate to provide safe or
healthful employment" (29 U.S.C. 652(8)). The Supreme Court, in its
decision on OSHA's benzene standard, interpreted section 3(8) to mean
that before promulgating any standard, the Secretary must evaluate
whether "significant risk[ ]" exists under current conditions and to
then determine whether that risk can be "eliminated or lessened"
through regulation (Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst.,
448 U.S. 607, 642 (1980) (plurality opinion) ("Benzene")). The
Court's holding is consistent with evidence in the legislative record,
with regard to section 6(b)(5) of the Act (29 U.S.C. 655(b)(5)), that
Congress intended the Agency to regulate unacceptably severe
occupational hazards, and not "to establish a utopia free from any
hazards" or to address risks comparable to those that exist in
virtually any occupation or workplace (116 Cong. Rec. 37614 (1970),
Leg. Hist. 480-82). It is also consistent with Section 6(g) of the OSH
Act, which states that, in determining regulatory priorities, "the
Secretary shall give due regard to the urgency of the need for
mandatory safety and health standards for particular industries,
trades, crafts, occupations, businesses, workplaces or work
environments" (29 U.S.C. 655(g)).
The Supreme Court in Benzene clarified that "[i]t is the Agency's
responsibility to determine, in the first instance, what it considers
to be a `significant' risk" (Benzene, 448 U.S. at 655), and that it
was not the Court's responsibility to "express any opinion on the . .
. difficult question of what factual determinations would warrant a
conclusion that significant risks are present which make promulgation
of a new standard reasonably necessary or appropriate" (Benzene, 448
U.S. at 659). The Court stated, however, that the section 6(f) (29
U.S.C. 655(b)(f)) substantial evidence standard applicable to OSHA's
significant risk determination does not require the Agency "to support
its finding that a significant risk exists with anything approaching
scientific certainty" (Benzene, 448 U.S. at 656). Rather, OSHA may
rely on "a body of reputable scientific thought" to which
"conservative assumptions in interpreting the data . . . " may be
applied, "risking error on the side of
overprotection" (Benzene, 448 U.S. at 656; see also United
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1248 (D.C.
Cir. 1980) ("Lead I") (noting the Benzene court's application of this
principle to carcinogens and applying it to the lead standard, which
was not based on carcinogenic effects)). OSHA may thus act with a
"pronounced bias towards worker safety" in making its risk
determinations (Bldg & Constr. Trades Dep't v. Brock, 838 F.2d 1258,
1266 (D.C. Cir. 1988) ("Asbestos II").
The Supreme Court further recognized that what constitutes
"significant risk" is "not a mathematical straitjacket" (Benzene,
448 U.S. at 655) and will be "based largely on policy considerations"
(Benzene, 448 U.S. at 655 n. 62). The Court gave the following example:
If . . . the odds are one in a billion that a person will die
from cancer by taking a drink of chlorinated water, the risk clearly
could not be considered significant. On the other hand, if the odds
are one in a thousand that regular inhalation of gasoline vapors
that are 2% benzene will be fatal, a reasonable person might well
consider the risk significant . . . (Benzene, 448 U.S. at 655).
Following Benzene, OSHA has, in many of its health standards,
considered the one-in-a-thousand metric when determining whether a
significant risk exists. Moreover, as "a prerequisite to more
stringent regulation" in all subsequent health standards, OSHA has,
consistent with the Benzene plurality decision, based each standard on
a finding of significant risk at the "then prevailing standard" of
exposure to the relevant hazardous substance (Asbestos II, 838 F.2d at
1263). The Agency's final risk assessment is derived from existing
scientific and enforcement data and its final conclusions are made only
after considering all evidence in the rulemaking record. Courts
reviewing the validity of these standards have uniformly held the
Secretary to the significant risk standard first articulated by the
Benzene plurality and have generally upheld the Secretary's significant
risk determinations as supported by substantial evidence and "a
reasoned explanation for his policy assumptions and conclusions"
(Asbestos II, 838 F.2d at 1266).
Once OSHA makes its significant risk finding, the "more stringent
regulation" (Asbestos II, 838 F.2d at 1263) it promulgates must be
"reasonably necessary or appropriate" to reduce or eliminate that
risk, within the meaning of section 3(8) of the Act (29 U.S.C. 652(8))
and Benzene (448 U.S. at 642) (see Asbestos II, 838 F.2d at 1269). The
courts have interpreted section 6(b)(5) of the OSH Act as requiring
OSHA to set the standard that eliminates or reduces risk to the lowest
feasible level; as discussed below, the limits of technological and
economic feasibility usually determine where the new standard is set
(see UAW v. Pendergrass, 878 F.2d 389, 390 (D.C. Cir. 1989)). In
choosing among regulatory alternatives, however, "[t]he determination
that [one standard] is appropriate, as opposed to a marginally [more or
less protective] standard, is a technical decision entrusted to the
expertise of the agency . . . " (Nat'l Mining Ass'n v. Mine Safety and
Health Admin., 116 F.3d 520, 528 (D.C. Cir. 1997)) (analyzing a Mine
Safety and Health Administration standard under the Benzene significant
risk standard). In making its choice, OSHA may incorporate a margin of
safety even if it theoretically regulates below the lower limit of
significant risk (Nat'l Mining Ass'n, 116 F.3d at 528 (citing American
Petroleum Inst. v. Costle, 665 F.2d 1176, 1186 (D.C. Cir. 1982))).
Working Life Assumption
The OSH Act requires OSHA to set the standard that most adequately
protects employees against harmful workplace exposures for the period
of their "working life" (29 U.S.C. 655(b)(5)). OSHA's longstanding
policy is to define "working life" as constituting 45 years; thus, it
assumes 45 years of exposure when evaluating the risk of material
impairment to health caused by a toxic or hazardous substance. This
policy is not based on empirical data that most employees are exposed
to a particular hazard for 45 years. Instead, OSHA has adopted the
practice to be consistent with the statutory directive that "no
employee" suffer material impairment of health "even if" such
employee is exposed to the hazard for the period of his or her working
life (see 74 FR 44796 (8/31/09)). OSHA's policy was given judicial
approval in a challenge to an OSHA standard that lowered the
permissible exposure limit (PEL) for asbestos (Asbestos II, 838 F.2d at
1264-1265). In that case, the petitioners claimed that the median
duration of employment in the affected industry sectors was only five
years. Therefore, according to petitioners, OSHA erred in assuming a
45-year working life in calculating the risk of health effects caused
by asbestos exposure. The D.C. Circuit disagreed, stating "[e]ven if
it is only the rare worker who stays with asbestos-related tasks for 45
years, that worker would face a 64/1000 excess risk of contracting
cancer; Congress clearly authorized OSHA to protect such a worker"
(Asbestos II, 838 F.2d at 1264-1265). OSHA might calculate the health
risks of exposure, and the related benefits of lowering the exposure
limit, based on an assumption of a shorter working life, such as 25
years, but such estimates are for informational purposes only.
Best Available Evidence
Section 6(b)(5) of the Act requires OSHA to set standards "on the
basis of the best available evidence" and to consider the "latest
available scientific data in the field" (29 U.S.C. 655(b)(5)). As
noted above, the Supreme Court, in its Benzene decision, explained that
OSHA must look to "a body of reputable scientific thought" in making
its material harm and significant risk determinations, while noting
that a reviewing court must "give OSHA some leeway where its findings
must be made on the frontiers of scientific knowledge" (Benzene, 448
U.S. at 656).
The courts of appeals have afforded OSHA similar latitude to issue
health standards in the face of scientific uncertainty. The Second
Circuit, in upholding the vinyl chloride standard, stated: "[T]he
ultimate facts here in dispute are `on the frontiers of scientific
knowledge', and, though the factual finger points, it does not
conclude. Under the command of OSHA, it remains the duty of the
Secretary to act to protect the workingman, and to act even in
circumstances where existing methodology or research is deficient"
(Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301, 1308
(2d Cir. 1975) (quoting Indus. Union Dep't, AFL-CIO v. Hodgson, 499
F.2d 467, 474 (D.C. Cir. 1974) ("Asbestos I"))). The D.C. Circuit, in
upholding the cotton dust standard, stated: "OSHA's mandate
necessarily requires it to act even if information is incomplete when
the best available evidence indicates a serious threat to the health of
workers" (Am. Fed'n of Labor & Cong. of Indus. Orgs. v. Marshall, 617
F.2d 636, 651 (D.C. Cir. 1979), aff'd in part and vacated in part on
other grounds, American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S.
490 (1981)). When there is disputed scientific evidence in the record,
OSHA must review the evidence on both sides and "reasonably resolve"
the dispute (Pub. Citizen Health Research Grp. v. Tyson, 796 F.2d 1479,
1500 (D.C. Cir. 1986)). The Court in Public Citizen further noted that,
where "OSHA has the expertise we lack and it has exercised that
expertise by carefully reviewing the scientific data," a dispute
within the scientific community is not occasion for the reviewing court
to take sides about which view is correct (Pub. Citizen Health Research
Grp., 796 F.2d
at 1500) or for OSHA or the courts to " `be paralyzed by debate
surrounding diverse medical opinions' " (Pub. Citizen Health Research
Grp., 796 F.2d at 1497 (quoting H.R. Rep. No. 91-1291, 91st Cong., 2d
Sess. 18 (1970), reprinted in Legislative History of the Occupational
Safety and Health Act of 1970 at 848 (1971))). Provided the Agency gave
adequate notice in the proposal's preamble discussion of potential
regulatory alternatives that the Secretary would be considering one or
more stated options for regulation, OSHA is not required to prefer the
option in the text of the proposal over a given regulatory alternative
that was addressed in the rulemaking if substantial evidence in the
record supports inclusion of the alternative in the final standard. See
Owner-Operator Independent Drivers Ass'n, Inc. v. Federal Motor Carrier
Safety Admin., 494 F.3d 188, 209 (D.C. Cir. 2007) (notice by agency
concerning modification of sleeper-berth requirements for truck drivers
was sufficient because proposal listed several options and asked a
question regarding the details of the one option that ultimately
appeared in final rule); Kooritzky v. Reich, 17 F.3d 1509, 1513 (D.C.
Cir. 1994) (noting that a final rule need not match a proposed rule, as
long as "the agency has alerted interested parties to the possibility
of the agency's adopting a rule different than the one proposed" and
holding that agency failed to comply with notice and comment
requirements when "preamble in July offered no clues of what was to
come in October").
Feasibility
The OSH Act requires that, in setting a standard, OSHA must
eliminate the risk of material health impairment "to the extent
feasible" (29 U.S.C. 655(b)(5)). The statutory mandate to consider the
feasibility of the standard encompasses both technological and economic
feasibility; these analyses have been done primarily on an industry-by-
industry basis (Lead I, 647 F.2d at 1264, 1301). The Agency has also
used application groups, defined by common tasks, as the structure for
its feasibility analyses (Pub. Citizen Health Research Grp. v. OSHA,
557 F.3d 165, 177-179 (3d Cir. 2009)). The Supreme Court has broadly
defined feasible as "capable of being done" (Cotton Dust, 452 U.S. at
509-510).
Although OSHA must set the most protective PEL that the Agency
finds to be technologically and economically feasible, it retains
discretion to set a uniform PEL even when the evidence demonstrates
that certain industries or operations could reasonably be expected to
meet a lower PEL. OSHA health standards generally set a single PEL for
all affected employers; OSHA exercised this discretion most recently in
its final rules on occupational exposure to Chromium (VI) (71 FR 10100,
10337-10338 (2/28/2006) and Respirable Crystalline Silica (81 FR 16285,
16576-16575 (3/25/2016); see also 62 FR 1494, 1575 (1/10/97) (methylene
chloride)). In its decision upholding the chromium (VI) standard,
including the uniform PEL, the Court of Appeals for the Third Circuit
addressed this issue as one of deference, stating "OSHA's decision to
select a uniform exposure limit is a legislative policy decision that
we will uphold as long as it was reasonably drawn from the record"
(Chromium (VI), 557 F.3d at 183 (3d Cir. 2009)); see also Am. Iron &
Steel Inst. v. OSHA, 577 F.2d 825, 833 (3d Cir. 1978)). OSHA's reasons
for choosing one chromium (VI) PEL, rather than imposing different PELs
on different application groups or industries, included: Multiple PELs
would create enforcement and compliance problems because many
workplaces, and even workers, were affected by multiple categories of
chromium (VI) exposure; discerning individual PELs for different groups
of establishments would impose a huge evidentiary burden on the Agency
and unnecessarily delay implementation of the standard; and a uniform
PEL would, by eliminating confusion and simplifying compliance, enhance
worker protection (Chromium (VI), 557 F.3d at 173, 183-184). The Court
held that OSHA's rationale for choosing a uniform PEL, despite evidence
that some application groups or industries could meet a lower PEL, was
reasonably drawn from the record and that the Agency's decision was
within its discretion and supported by past practice (Chromium (VI),
557 F.3d at 183-184).
Technological Feasibility
A standard is technologically feasible if the protective measures
it requires already exist, can be brought into existence with available
technology, or can be created with technology that can reasonably be
expected to be developed (Lead I, 647 F.2d at 1272; Amer. Iron & Steel
Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) ("Lead II")).
OSHA's standards may be "technology forcing," i.e., where the Agency
gives an industry a reasonable amount of time to develop new
technologies, OSHA is not bound by the "technological status quo"
(Lead I, 647 F.2d at 1264). While the test for technological
feasibility is normally articulated in terms of the ability of
employers to decrease exposures to the PEL, provisions such as exposure
measurement requirements must also be technologically feasible (see
Forging Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1453 (4th Cir.
1985)).
In its Lead decisions, the D.C. Circuit described OSHA's obligation
to demonstrate the technological feasibility of reducing occupational
exposure to a hazardous substance.
[W]ithin the limits of the best available evidence . . . OSHA
must prove a reasonable possibility that the typical firm will be
able to develop and install engineering and work practice controls
that can meet the PEL in most of its operations . . . The effect of
such proof is to establish a presumption that industry can meet the
PEL without relying on respirators . . . Insufficient proof of
technological feasibility for a few isolated operations within an
industry, or even OSHA's concession that respirators will be
necessary in a few such operations, will not undermine this general
presumption in favor of feasibility. Rather, in such operations
firms will remain responsible for installing engineering and work
practice controls to the extent feasible, and for using them to
reduce . . . exposure as far as these controls can do so (Lead I,
647 F.2d at 1272).
Additionally, the D.C. Circuit explained that "[f]easibility of
compliance turns on whether exposure levels at or below [the PEL] can
be met in most operations most of the time . . ." (Lead II, 939 F.2d
at 990).
Courts have given OSHA significant deference in reviewing its
technological feasibility findings. "So long as we require OSHA to
show that any required means of compliance, even if it carries no
guarantee of meeting the PEL, will substantially lower . . . exposure,
we can uphold OSHA's determination that every firm must exploit all
possible means to meet the standard" (Lead I, 647 F.2d at 1273). Even
in the face of significant uncertainty about technological feasibility
in a given industry, OSHA has been granted broad discretion in making
its findings (Lead I, 647 F.2d at 1285). "OSHA cannot let workers
suffer while it awaits . . . scientific certainty. It can and must make
reasonable [technological feasibility] predictions on the basis of
`credible sources of information,' whether data from existing plants or
expert testimony" (Lead I, 647 F.2d at 1266 (quoting Am. Fed'n of
Labor & Cong. of Indus. Orgs., 617 F.2d at 658)). For example, in Lead
I, the D.C. Circuit allowed OSHA to use, as best available evidence,
information about new and expensive industrial smelting processes that
had not yet been adopted in the U.S. and would require the rebuilding
of plants (Lead I, 647 F.2d at 1283-1284). Even under circumstances
where
OSHA's feasibility findings were less certain and the Agency was
relying on its "legitimate policy of technology forcing," the D.C.
Circuit approved of OSHA's feasibility findings when the Agency granted
lengthy phase-in periods to allow particular industries time to comply
(Lead I, 647 F.2d at 1279-1281, 1285).
OSHA is permitted to adopt a standard that some employers will not
be able to meet some of the time, with employers limited to challenging
feasibility at the enforcement stage (Lead I, 647 F.2d at 1273 & n.
125; Asbestos II, 838 F.2d at 1268). Even when the Agency recognized
that it might have to balance its general feasibility findings with
flexible enforcement of the standard in individual cases, the courts of
appeals have generally upheld OSHA's technological feasibility findings
(Lead II, 939 F.2d at 980; see Lead I, 647 F.2d at 1266-1273; Asbestos
II, 838 F.2d at 1268). Flexible enforcement policies have been approved
where there is variability in measurement of the regulated hazardous
substance or where exposures can fluctuate uncontrollably (Asbestos II,
838 F.2d at 1267-1268; Lead II, 939 F.2d at 991). A common means of
dealing with the measurement variability inherent in sampling and
analysis is for the Agency to add the standard sampling error to its
exposure measurements before determining whether to issue a citation
(e.g., 51 FR 22612, 22654 (06/20/86) (Asbestos Preamble)).
Economic Feasibility
In addition to technological feasibility, OSHA is required to
demonstrate that its standards are economically feasible. A reviewing
court will examine the cost of compliance with an OSHA standard "in
relation to the financial health and profitability of the industry and
the likely effect of such costs on unit consumer prices . . ." (Lead
I, 647 F.2d at 1265 (omitting citation)). As articulated by the D.C.
Circuit in Lead I, "OSHA must construct a reasonable estimate of
compliance costs and demonstrate a reasonable likelihood that these
costs will not threaten the existence or competitive structure of an
industry, even if it does portend disaster for some marginal firms"
(Lead I, 647 F.2d at 1272). A reasonable estimate entails assessing
"the likely range of costs and the likely effects of those costs on
the industry" (Lead I, 647 F.2d at 1266). As with OSHA's consideration
of scientific data and control technology, however, the estimates need
not be precise (Cotton Dust, 452 U.S. at 528-29 & n. 54) as long as
they are adequately explained. Thus, as the D.C. Circuit further
explained:
Standards may be economically feasible even though, from the
standpoint of employers, they are financially burdensome and affect
profit margins adversely. Nor does the concept of economic
feasibility necessarily guarantee the continued existence of
individual employers. It would appear to be consistent with the
purposes of the Act to envisage the economic demise of an employer
who has lagged behind the rest of the industry in protecting the
health and safety of employees and is consequently financially
unable to comply with new standards as quickly as other employers.
As the effect becomes more widespread within an industry, the
problem of economic feasibility becomes more pressing (Asbestos I,
499 F.2d. at 478).
OSHA standards therefore satisfy the economic feasibility criterion
even if they impose significant costs on regulated industries so long
as they do not cause massive economic dislocations within a particular
industry or imperil the very existence of the industry (Lead II, 939
F.2d at 980; Lead I, 647 F.2d at 1272; Asbestos I, 499 F.2d. at 478).
As with its other legal findings, OSHA "is not required to prove
economic feasibility with certainty, but is required to use the best
available evidence and to support its conclusions with substantial
evidence" ((Lead II, 939 F.2d at 980-981) (citing Lead I, 647 F.2d at
1267)).
Because section 6(b)(5) of the Act explicitly imposes the "to the
extent feasible" limitation on the setting of health standards, OSHA
is not permitted to use cost-benefit analysis to make its standards-
setting decisions (29 U.S.C. 655(b)(5)).
Congress itself defined the basic relationship between costs and
benefits, by placing the "benefit" of worker health above all
other considerations save those making attainment of this
"benefit" unachievable. Any standard based on a balancing of costs
and benefits by the Secretary that strikes a different balance than
that struck by Congress would be inconsistent with the command set
forth in Sec. 6(b)(5) (Cotton Dust, 452 U.S. at 509).
Thus, while OSHA estimates the costs and benefits of its proposed and
final rules, these calculations do not form the basis for the Agency's
regulatory decisions; rather, they are performed to ensure compliance
with requirements such as those in Executive Orders 12866 and 13563.
Structure of OSHA Health Standards
OSHA's health standards traditionally incorporate a comprehensive
approach to reducing occupational disease. OSHA substance-specific
health standards generally include the "hierarchy of controls,"
which, as a matter of OSHA's preferred policy, mandates that employers
install and implement all feasible engineering and work practice
controls before respirators may be used. The Agency's adherence to the
hierarchy of controls has been upheld by the courts (ASARCO, Inc. v.
OSHA, 746 F.2d 483, 496-498 (9th Cir. 1984); Am. Iron & Steel Inst. v.
OSHA, 182 F.3d 1261, 1271 (11th Cir. 1999)). In fact, courts view the
legal standard for proving technological feasibility as incorporating
the hierarchy: "OSHA must prove a reasonable possibility that the
typical firm will be able to develop and install engineering and work
practice controls that can meet the PEL in most of its operations. . .
. The effect of such proof is to establish a presumption that industry
can meet the PEL without relying on respirators" (Lead I, 647 F.2d at
1272).
The reasons supporting OSHA's continued reliance on the hierarchy
of controls, as well as its reasons for limiting the use of
respirators, are numerous and grounded in good industrial hygiene
principles (see discussion in Section XVI. Summary and Explanation of
the Standards, Methods of Compliance). The hierarchy of controls
focuses on removing harmful airborne materials at their source "to
prevent atmospheric contamination" to which the employee would be
exposed, rather than relying on the proper functioning of a respirator
as the primary means of protecting the employee (see 29 CFR 1910.134,
1910.1000(e), 1926.55(b)).
In health standards such as this one, the hierarchy of controls is
augmented by ancillary provisions. These provisions work with the
hierarchy of controls and personal protective equipment requirements to
provide comprehensive protection to employees in affected workplaces.
Such provisions typically include exposure assessment, medical
surveillance, hazard communication, and recordkeeping.
The OSH Act compels OSHA to require all feasible measures for
reducing significant health risks (29 U.S.C. 655(b)(5); Pub. Citizen
Health Research Grp., 796 F.2d at 1505 ("if in fact a STEL [short-term
exposure limit] would further reduce a significant health risk and is
feasible to implement, then the OSH Act compels the agency to adopt it
(barring alternative avenues to the same result)"). When there is
significant risk below the PEL, the D.C. Circuit indicated that OSHA
should use its regulatory authority to impose additional requirements
on employers when those requirements will result in
a greater than de minimis incremental benefit to workers' health
(Asbestos II, 838 F.2d at 1274). The Supreme Court alluded to a similar
issue in Benzene, pointing out that "in setting a permissible exposure
level in reliance on less-than-perfect methods, OSHA would have the
benefit of a backstop in the form of monitoring and medical testing"
(Benzene, 448 U.S. at 657). OSHA concludes that the ancillary
provisions in this final standard provide significant benefits to
worker health by providing additional layers and types of protection to
employees exposed to beryllium and beryllium compounds.
III. Events Leading to the Final Standards
The first occupational exposure limit for beryllium was set in 1949
by the Atomic Energy Commission (AEC), which required that beryllium
exposure in the workplaces under its jurisdiction be limited to 2
µg/m3\ as an 8-hour time-weighted average (TWA), and 25
µg/m3\ as a peak exposure never to be exceeded (Document ID
1323). These exposure limits were adopted by all AEC installations
handling beryllium, and were binding on all AEC contractors involved in
the handling of beryllium.
In 1956, the American Industrial Hygiene Association (AIHA)
published a Hygienic Guide which supported the AEC exposure limits. In
1959, the American Conference of Governmental Industrial Hygienists
(ACGIH[supreg]) also adopted a Threshold Limit Value (TLV[supreg]) of 2
µg/m3\ as an 8-hour TWA (Borak, 2006). In 1970, ANSI issued a
national consensus standard for beryllium and beryllium compounds (ANSI
Z37.29-1970). The standard set a permissible exposure limit (PEL) for
beryllium and beryllium compounds at 2 µg/m3\ as an 8-hour TWA;
5 µg/m3\ as an acceptable ceiling concentration; and 25
µg/m3\ as an acceptable maximum peak above the acceptable
ceiling concentration for a maximum duration of 30 minutes in an 8-hour
shift (Document ID 1303).
In 1971, OSHA adopted, under Section 6(a) of the Occupational
Safety and Health Act of 1970, and made applicable to general industry,
the ANSI standard (Document ID 1303). Section 6(a) provided that in the
first two years after the effective date of the Act, OSHA was to
promulgate "start-up" standards, on an expedited basis and without
public hearing or comment, based on national consensus or established
Federal standards that improved employee safety or health. Pursuant to
that authority, in 1971, OSHA promulgated approximately 425 PELs for
air contaminants, including beryllium, derived principally from Federal
standards applicable to government contractors under the Walsh-Healey
Public Contracts Act, 41 U.S.C. 35, and the Contract Work Hours and
Safety Standards Act (commonly known as the Construction Safety Act),
40 U.S.C. 333. The Walsh-Healey Act and Construction Safety Act
standards, in turn, had been adopted primarily from ACGIH[supreg]'s
TLV[supreg]s as well as several from United States of America Standards
Institute (USASI) [later the American National Standards Institute
(ANSI)].
The National Institute for Occupational Safety and Health (NIOSH)
issued a document entitled Criteria for a Recommended Standard:
Occupational Exposure to Beryllium (Criteria Document) in June 1972
with Recommended Exposure Limits (RELs) of 2 µg/m3\ as an 8-hour
TWA and 25 µg/m3\ as an acceptable maximum peak above the
acceptable ceiling concentration for a maximum duration of 30 minutes
in an 8-hour shift. OSHA reviewed the findings and recommendations
contained in the Criteria Document along with the AEC control
requirements for beryllium exposure. OSHA also considered existing data
from animal and epidemiological studies, and studies of industrial
processes of beryllium extraction, refinement, fabrication, and
machining. In 1975, OSHA asked NIOSH to update the evaluation of the
existing data pertaining to the carcinogenic potential of beryllium. In
response to OSHA's request, the Director of NIOSH stated that, based on
animal data and through all possible routes of exposure including
inhalation, "beryllium in all likelihood represents a carcinogenic
risk to man."
In October 1975, OSHA proposed a new beryllium standard for all
industries based on information from studies finding that beryllium
caused cancer in animals (40 FR 48814 (10/17/75)). Adoption of this
proposal would have lowered the 8-hour TWA exposure limit from 2
µg/m3\ to 1 µg/m3\. In addition, the proposal included
ancillary provisions for such topics as exposure monitoring, hygiene
facilities, medical surveillance, and training related to the health
hazards from beryllium exposure. The rulemaking was never completed.
In 1977, NIOSH recommended an exposure limit of 0.5 µg/m3\
and identified beryllium as a potential occupational carcinogen. In
December 1998, ACGIH published a Notice of Intended Change for its
beryllium exposure limit. The notice proposed a lower TLV of 0.2
µg/m3\ over an 8-hour TWA based on evidence of CBD and
sensitization in exposed workers. Then in 2009, ACGIH adopted a revised
TLV for beryllium that lowered the TWA to 0.05 μg/m3\ (inhalable)
(see Document ID 1755, Tr. 136).
In 1999, the Department of Energy (DOE) issued a Chronic Beryllium
Disease Prevention Program (CBDPP) Final Rule for employees exposed to
beryllium in its facilities (Document ID 1323). The DOE rule set an
action level of 0.2 μg/m3\, and adopted OSHA's PEL of 2 μg/m3\
or any more stringent PEL OSHA might adopt in the future (10 CFR
850.22; 64 FR 68873 and 68906, Dec. 8, 1999).
Also in 1999, OSHA was petitioned by the Paper, Allied-Industrial,
Chemical and Energy Workers International Union (PACE) (Document ID
0069) and by Dr. Lee Newman and Ms. Margaret Mroz, from the National
Jewish Health (NJH) (Document ID 0069), to promulgate an Emergency
Temporary Standard (ETS) for beryllium in the workplace. In 2001, OSHA
was petitioned for an ETS by Public Citizen Health Research Group and
again by PACE (Document ID 0069). In order to promulgate an ETS, the
Secretary of Labor must prove (1) that employees are exposed to grave
danger from exposure to a hazard, and (2) that such an emergency
standard is necessary to protect employees from such danger (29 U.S.C.
655(c) [6(c)]). The burden of proof is on the Department and because of
the difficulty of meeting this burden, the Department usually proceeds
when appropriate with ordinary notice and comment [section 6(b)]
rulemaking rather than a 6(c) ETS. Thus, instead of granting the ETS
requests, OSHA instructed staff to further collect and analyze research
regarding the harmful effects of beryllium in preparation for possible
section 6(b) rulemaking.
On November 26, 2002, OSHA published a Request for Information
(RFI) for "Occupational Exposure to Beryllium" (Document ID 1242).
The RFI contained questions on employee exposure, health effects, risk
assessment, exposure assessment and monitoring methods, control
measures and technological feasibility, training, medical surveillance,
and impact on small business entities. In the RFI, OSHA expressed
concerns about health effects such as chronic beryllium disease (CBD),
lung cancer, and beryllium sensitization. OSHA pointed to studies
indicating that even short-term exposures below OSHA's PEL of 2
µg/m3\ could lead to CBD. The RFI also cited studies describing
the relationship between beryllium sensitization and CBD (67 FR at
70708). In addition,
OSHA stated that beryllium had been identified as a carcinogen by
organizations such as NIOSH, the International Agency for Research on
Cancer (IARC), and the Environmental Protection Agency (EPA); and
cancer had been evidenced in animal studies (67 FR at 70709).
On November 15, 2007, OSHA convened a Small Business Advocacy
Review Panel for a draft proposed standard for occupational exposure to
beryllium. OSHA convened this panel under Section 609(b) of the
Regulatory Flexibility Act (RFA), as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et
seq.).
The Panel included representatives from OSHA, the Solicitor's
Office of the Department of Labor, the Office of Advocacy within the
Small Business Administration, and the Office of Information and
Regulatory Affairs of the Office of Management and Budget. Small Entity
Representatives (SERs) made oral and written comments on the draft rule
and submitted them to the panel.
The SBREFA Panel issued a report on January 15, 2008 which included
the SERs' comments. SERs expressed concerns about the impact of the
ancillary requirements such as exposure monitoring and medical
surveillance. Their comments addressed potential costs associated with
compliance with the draft standard, and possible impacts of the
standard on market conditions, among other issues. In addition, many
SERs sought clarification of some of the ancillary requirements such as
the meaning of "routine" contact or "contaminated surfaces."
OSHA then developed a draft preliminary beryllium health effects
evaluation (Document ID 1271) and a draft preliminary beryllium risk
assessment (Document ID 1272), and in 2010, OSHA hired a contractor to
oversee an independent scientific peer review of these documents. The
contractor identified experts familiar with beryllium health effects
research and ensured that these experts had no conflict of interest or
apparent bias in performing the review. The contractor selected five
experts with expertise in such areas as pulmonary and occupational
medicine, CBD, beryllium sensitization, the Beryllium Lymphocyte
Proliferation Test (BeLPT), beryllium toxicity and carcinogenicity, and
medical surveillance. Other areas of expertise included animal
modeling, occupational epidemiology, biostatistics, risk and exposure
assessment, exposure-response modeling, beryllium exposure assessment,
industrial hygiene, and occupational/environmental health engineering.
Regarding the preliminary health effects evaluation, the peer
reviewers concluded that the health effect studies were described
accurately and in sufficient detail, and OSHA's conclusions based on
the studies were reasonable (Document ID 1210). The reviewers agreed
that the OSHA document covered the significant health endpoints related
to occupational beryllium exposure. Peer reviewers considered the
preliminary conclusions regarding beryllium sensitization and CBD to be
reasonable and well presented in the draft health evaluation section.
All reviewers agreed that the scientific evidence supports
sensitization as a necessary condition in the development of CBD. In
response to reviewers' comments, OSHA made revisions to more clearly
describe certain sections of the health effects evaluation. In
addition, OSHA expanded its discussion regarding the BeLPT.
Regarding the preliminary risk assessment, the peer reviewers were
highly supportive of the Agency's approach and major conclusions
(Document ID 1210). The peer reviewers stated that the key studies were
appropriate and their selection clearly explained in the document. They
regarded the preliminary analysis of these studies to be reasonable and
scientifically sound. The reviewers supported OSHA's conclusion that
substantial risk of sensitization and CBD were observed in facilities
where the highest exposure generating processes had median full-shift
exposures around 0.2 µg/m3\ or higher, and that the greatest
reduction in risk was achieved when exposures for all processes were
lowered to 0.1 µg/m3\ or below.
In February 2012, the Agency received for consideration a draft
recommended standard for beryllium (Materion and USW, 2012, Document ID
0754). This draft standard was the product of a joint effort between
two stakeholders: Materion Corporation, a leading producer of beryllium
and beryllium products in the United States, and the United
Steelworkers, an international labor union representing workers who
manufacture beryllium alloys and beryllium-containing products in a
number of industries. They sought to craft an OSHA-like model beryllium
standard that would have support from both labor and industry. OSHA has
considered this proposal along with other information submitted during
the development of the Notice of Proposed Rulemaking (NPRM) for
beryllium. As described in greater detail in the Introduction to the
Summary and Explanation of the final rule, there was substantial
agreement between the submitted joint standard and the OSHA proposed
standard.
On August 7, 2015, OSHA published its NPRM in the Federal Register
(80 FR 47565 (8/7/15)). In the NPRM, the Agency made a preliminary
determination that employees exposed to beryllium and beryllium
compounds at the preceding PEL face a significant risk to their health
and that promulgating the proposed standard would substantially reduce
that risk. The NPRM (Section XVIII) also responded to the SBREFA Panel
recommendations, which OSHA carefully considered, and clarified the
requirements about which SERs expressed confusion. OSHA also discussed
the regulatory alternatives recommended by the SBREFA Panel in NPRM,
Section XVIII, and in the PEA (Document ID 0426).
The NPRM invited interested stakeholders to submit comments on a
variety of issues and indicated that OSHA would schedule a public
hearing upon request. Commenters submitted information and suggestions
on a variety of topics. In addition, in response to a request from the
Non-Ferrous Founders' Society, OSHA scheduled an informal public
hearing on the proposed rule. The Agency invited interested persons to
participate by providing oral testimony and documentary evidence at the
hearing. OSHA also welcomed presentation of data and documentary
evidence that would provide the Agency with the best available evidence
to use in determining whether to develop a final rule.
The public hearing was held in Washington, DC on March 21 and 22,
2016. Administrative Law Judge William Colwell presided over the
hearing. The Agency heard testimony from several organizations, such as
public health groups, the Non-Ferrous Founders' Society, other industry
representatives, and labor unions. Following the hearing, participants
who had filed notices of intent to appear were allowed 30 days--until
April 21, 2016--to submit additional evidence and data, and an
additional 15 days--until May 6, 2016--to submit final briefs,
arguments, and summations (Document ID 1756, Tr. 326).
In 2016, in an action parallel to OSHA's rulemaking, DOE proposed
to update its action level to 0.05 μg/m3\ (81 FR 36704-36759, June
7, 2016). The DOE action level triggers workplace precautions and
control measures such as periodic monitoring, exposure
reduction or minimization, regulated areas, hygiene facilities and
practices, respiratory protection, protective clothing and equipment,
and warning signs (Document ID 1323; 10 CFR 850.23(b)). Unlike OSHA's
PEL, however, DOE's selection of an action level is not required to
meet statutory requirements of technological and economic feasibility.
In all, the OSHA rulemaking record contains over 1,900 documents,
including all the studies OSHA relied on in its preliminary health
effects and risk assessment analyses, the hearing transcript and
submitted testimonies, the joint Materion-USW draft proposed standard,
and the pre- and post-hearing comments and briefs. The final rule on
occupational exposure to beryllium and beryllium compounds is thus
based on consideration of the entire record of this rulemaking
proceeding, including materials discussed or relied upon in the
proposal, the record of the hearing, and all written comments and
exhibits timely received. Based on this comprehensive record, OSHA
concludes that employees exposed to beryllium and beryllium compounds
are at significant risk of material impairment of health, including
chronic beryllium disease and lung cancer. The Agency concludes that
the PEL of 0.2 μg/m3\ reduces the significant risks of material
impairments of health posed to workers by occupational exposure to
beryllium and beryllium compounds to the maximum extent that is
technologically and economically feasible. OSHA's substantive
determinations with regard to the comments, testimony, and other
information in the record, the legal standards governing the decision-
making process, and the Agency's analysis of the data resulting in its
assessments of risks, benefits, technological and economic feasibility,
and compliance costs are discussed elsewhere in this preamble. More
technical or complex issues are discussed in greater detail in the
background documents referenced in this preamble.
IV. Chemical Properties and Industrial Uses
Chemical and Physical Properties
Beryllium (Be; CAS Number 7440-41-7) is a silver-grey to greyish-
white, strong, lightweight, and brittle metal. It is a Group IIA
element with an atomic weight of 9.01, atomic number of 4, melting
point of 1,287 [deg]C, boiling point of 2,970 [deg]C, and a density of
1.85 at 20 [deg]C (Document ID 0389, p. 1). It occurs naturally in
rocks, soil, coal, and volcanic dust (Document ID 1567, p. 1).
Beryllium is insoluble in water and soluble in acids and alkalis. It
has two common oxidation states, Be(0) and Be(+2). There are several
beryllium compounds with unique CAS numbers and chemical and physical
properties. Table IV-1 describes the most common beryllium compounds.
Table IV-1--Properties of Beryllium and Beryllium Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Synonyms and Molecular Melting point
Chemical name CAS No. trade names weight ([deg]C) Description Density (g/cm3) Solubility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium metal............... 7440-41-7 Beryllium; 9.0122 1287............. Grey, close- 1.85 (20 [deg]C). Soluble in most
beryllium-9, packed, dilute acids
beryllium hexagonal, and alkali;
element; brittle metal. decomposes in
beryllium hot water;
metallic. insoluble in
mercury and
cold water.
Beryllium chloride............ 7787-47-5 Beryllium 79.92 399.2............ Colorless to 1.899 (25 [deg]C) Soluble in
dichloride. slightly yellow; water, ethanol,
orthorhombic, diethyl ether
deliques-cent and pyridine;
crystal. slightly
soluble in
benzene, carbon
disulfide and
chloroform;
insoluble in
acetone,
ammonia, and
toluene.
Beryllium fluoride............ 7787-49-7 Beryllium 47.01 555.............. Colorless or 1.986............ Soluble in
(12323-05-6) difluoride. white, water, sulfuric
amorphous, acid, mixture
hygroscopic of ethanol and
solid. diethyl ether;
slightly
soluble in
ethanol;
insoluble in
hydrofluoric
acid.
Beryllium hydroxide........... 13327-32-7 Beryllium 43.3 138 (decomposes White, amorphous, 1.92............. Soluble in hot
(1304-49-0) dihydroxide. to beryllium amphoteric concentrated
oxide). powder. acids and
alkali;
slightly
soluble in
dilute alkali;
insoluble in
water.
Beryllium sulfate............. 13510-49-1 Sulfuric acid, 105.07 550-600 [deg]C Colorless crystal 2.443............ Forms soluble
beryllium salt (decomposes to tetrahydrate in
(1:1). beryllium oxide). hot water;
insoluble in
cold water.
Beryllium sulfate tetrhydrate. 7787-56-6 Sulfuric acid; 177.14 100 [deg]C....... Colorless, 1.713............ Soluble in
beryllium salt tetragonal water; slightly
(1:1), crystal. soluble in
tetrahydrate. concentrated
sulfuric acid;
insoluble in
ethanol.
Beryllium Oxide............... 1304-56-9 Beryllia; 25.01 2508-2547 [deg]C. Colorless to 3.01 (20 [deg]C). Soluble in
beryllium white, hexagonal concentrated
monoxide crystal or acids and
thermalox TM. amorphous, alkali;
amphoteric insoluble in
powder. water.
Beryllium carbonate........... 1319-43-3 Carbonic acid, 112.05 No data.......... White powder..... No data.......... Soluble in acids
beryllium salt, and alkali;
mixture with insoluble in
beryllium cold water;
hydroxide. decomposes in
hot water.
Beryllium nitrate trihydrate.. 7787-55-5 Nitric acid, 187.97 60............... White to faintly 1.56............. Very soluble in
beryllium salt, yellowish, water and
trihydrate. deliquescent ethanol.
mass.
Beryllium phosphate........... 13598-15-7 Phosphoric acid, 104.99 No data.......... Not reported..... Not reported..... Slightly soluble
beryllium salt in water.
(1:1).
--------------------------------------------------------------------------------------------------------------------------------------------------------
ATSDR, 2002.
The physical and chemical properties of beryllium were realized
early in the 20th century, and it has since gained commercial
importance in a wide range of industries. Beryllium is lightweight,
hard, spark resistant, non-magnetic, and has a high melting point. It
lends strength, electrical and thermal conductivity, and fatigue
resistance to alloys (Document ID 0389, p. 1). Beryllium also has a
high affinity for oxygen in air and water, which can cause a thin
surface film of beryllium oxide to form on the bare metal, making it
extremely resistant to corrosion. These properties make beryllium
alloys highly suitable for defense, nuclear, and aerospace applications
(Document ID 1342, pp. 45, 48).
There are approximately 45 mineralized forms of beryllium. In the
United States, the predominant mineral form mined commercially and
refined into pure beryllium and beryllium alloys is bertrandite.
Bertrandite, while containing less than 1% beryllium compared to 4% in
beryl, is easily and efficiently processed into beryllium hydroxide
(Document ID 1342, p. 48). Imported beryl is also converted into
beryllium hydroxide as the United States has very little beryl that can
be economically mined (Document ID 0616, p. 28).
Industrial Uses
Materion Corporation (Materion), formerly called Brush Wellman, is
the only producer of primary beryllium in the United States. Beryllium
is used in a variety of industries, including aerospace, defense,
telecommunications, automotive, electronic, and medical specialty
industries. Pure beryllium metal is used in a range of products such as
X-ray transmission windows, nuclear reactor neutron reflectors, nuclear
weapons, precision instruments, rocket propellants, mirrors, and
computers (Document ID 0389, p. 1). Beryllium oxide is used in
components such as ceramics, electrical insulators, microwave oven
components, military vehicle armor, laser structural components, and
automotive ignition systems (Document ID 1567, p. 147). Beryllium oxide
ceramics are used to produce sensitive electronic items such as lasers
and satellite heat sinks.
Beryllium alloys, typically beryllium/copper or beryllium/aluminum,
are manufactured as high beryllium content or low beryllium content
alloys. High content alloys contain greater than 30% beryllium. Low
content alloys are typically less than 3% beryllium. Beryllium alloys
are used in automotive electronics (e.g., electrical connectors and
relays and audio components), computer components, home appliance
parts, dental appliances (e.g., crowns), bicycle frames, golf clubs,
and other articles (Document ID 0389, p. 2; 1278, p. 182; 1280, pp. 1-
2; 1281, pp. 816, 818). Electrical components and conductors are
stamped and formed from beryllium alloys. Beryllium-copper alloys are
used to make switches in automobiles (Document ID 1280, p. 2; 1281, p.
818) and connectors, relays, and switches in computers, radar,
satellite, and telecommunications equipment (Document ID 1278, p. 183).
Beryllium-aluminum alloys are used in the construction of aircraft,
high resolution medical and industrial X-ray equipment, and mirrors to
measure weather patterns (Document ID 1278, p. 183). High content and
low content beryllium alloys are precision machined for military and
aerospace applications. Some welding consumables are also manufactured
using beryllium.
Beryllium is also found as a trace metal in materials such as
aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive
blasting grits such as coal slag and copper slag contain varying
concentrations of beryllium, usually less than 0.1% by weight. The
burning of bituminous and sub-bituminous coal for power generation
causes the naturally occurring beryllium in coal to accumulate in the
coal fly ash byproduct. Scrap and waste metal for smelting and refining
may also contain beryllium. A detailed discussion of the industries and
job tasks using beryllium is included in the Preliminary Economic
Analysis (Document ID 0385, 0426).
Occupational exposure to beryllium can occur from inhalation of
dusts, fume, and mist. Beryllium dusts are created during operations
where beryllium is cut, machined, crushed, ground, or otherwise
mechanically sheared. Mists can also form during operations that use
machining fluids. Beryllium fume can form while welding with or on
beryllium components, and from hot processes such as those found in
metal foundries.
Occupational exposure to beryllium can also occur from skin, eye,
and mucous membrane contact with beryllium particulate or solutions.
V. Health Effects
Overview of Findings and Supportive Comments
As discussed in detail throughout this section (section V, Final
Health Effects) and in Section VI, Final Quantitative Risk Assessment
and Significance of Risk, OSHA finds, based upon the best available
evidence in the record, that exposure to soluble and poorly soluble
forms of beryllium are associated with several adverse health outcomes
including sensitization, chronic beryllium disease, acute beryllium
disease and lung cancer.
The findings and conclusions in this section are consistent with
those of the National Academies of Sciences (NAS), the World Health
Organization's International Agency for Research on Cancer (IARC), the
U.S. Department of Health and Human Services' (HHS) National Toxicology
Program (NTP), the National Institute for Occupational Safety and
Health (NIOSH), the Agency for Toxic Substance and Disease Registry
(ATSDR), the European Commission on Health, Safety and Hygiene at Work,
and many other organizations and individuals, as evidenced in the
rulemaking record and further discussed below. Other scientific
organizations and governments have recognized the strong body of
scientific evidence pointing to the health risks of exposure to
beryllium and have deemed it necessary to take action to reduce those
risks. In 1999, the Department of Energy (DOE) updated its airborne
beryllium concentration action level to 0.2 μg/m3\ (Document ID
1323). In 2009, the American Conference of Governmental Industrial
Hygienists (ACGIH), a professional society that has been recommending
workplace exposure limits for six decades, revised its Threshold Limit
Value (TLV) for beryllium and beryllium-containing compounds to 0.05
μg/m3\ (Document ID 1304).
In finalizing this Health Effects preamble section for the final
rule, OSHA updated the preliminary Health Effects section published in
the NPRM based on the stakeholder response received by the Agency
during the public comment period and public hearing. OSHA also
corrected several non-substantive errors that were published in the
NPRM as well as those identified by NIOSH and Materion including
several minor organizational changes made to sections V.D.3 and V.E.2.b
(Document ID 1671, pp. 10-11; 1662, pp. 3-5). A section titled "Dermal
Effects" was added to V.F.5 based on comments received by the American
Thoracic Society (ATS), National Jewish Health, and the National
Supplemental Screening Program (Document ID 1688, p. 2; 1664, p. 5;
1677, p. 3). Additionally, the Agency responded to relevant stakeholder
comments contained in specific sections.
In developing its review of the preliminary health effects from
beryllium exposure and assessment of risk for the NPRM, OSHA prepared a
pair of draft documents, entitled "Occupation Exposure to Beryllium:
Preliminary Health Effects Evaluation" (OSHA, 2010, Document ID 1271)
and "Preliminary Beryllium Risk Assessment" (OSHA, 2010, Document ID
1272), that underwent independent scientific peer review in accordance
with the Office of Management and Budget's (OMB) Information Quality
Bulletin for Peer Review. Eastern Research Group, Inc. (ERG), under
contract with OSHA, selected five highly qualified experts with
collective expertise in occupational epidemiology, occupational
medicine, toxicology, immunology, industrial hygiene, and risk
assessment methodology.2 The peer reviewers responded to 27 questions
that covered the accuracy, completeness, and understandability of key
studies and adverse health endpoints as well as questions regarding the
adequacy, clarity and reasonableness of the risk analysis (ERG, 2010;
Document ID 1270).
---------------------------------------------------------------------------
2 The five selected peer reviewers were John Balmes, MD,
University of California-San Francisco; Patrick Breysse, Ph.D.,
Johns Hopkins University, Bloomberg School of Public Health; Terry
Gordon, Ph.D., New York University School of Medicine; Milton
Rossman, MD, University of Pennsylvania School of Medicine; Kyle
Steenland, Ph.D., Emory University, Rollins School of Public Health.
---------------------------------------------------------------------------
Overall, the peer reviewers found that the OSHA draft health
effects evaluation described the studies in sufficient detail,
appropriately addressed their strengths and limitations, and drew
scientifically sound conclusions. The peer reviewers were also
supportive of the Agency's preliminary risk assessment approach and the
major conclusions. OSHA provided detailed responses to reviewer
comments in its publication of the NPRM (80 FR 47646-47652, 8/7/2015).
Revisions to the draft health effects evaluation and preliminary risk
assessment in response to the peer review comments were reflected in
sections V and VI of the same publication (80 FR 47581-47646, 8/7/
2015). OSHA received public comment and testimony on the Health Effects
and Preliminary Risk Assessment sections published in the NPRM, which
are discussed in this preamble.
The Agency received a wide variety of stakeholder comments and
testimony for this rulemaking on issues related to the health effects
and risk of beryllium exposure. Statements supportive of OSHA's Health
Effects section include comments from NIOSH, the National Safety
Council, the American Thoracic Society (ATS), Representative Robert C.
"Bobby" Scott, Ranking Member of Committee on Education and the
Workforce, the U.S. House of Representatives, national labor
organizations (American Federation of Labor--Congress of Industrial
Organizations (AFL-CIO), North American Building Trades Unions (NABTU),
United Steelworkers (USW), Public Citizen, ORCHSE, experts from
National Jewish Health (Lisa Maier, MD and Margaret Mroz, MSPH), the
American Association for Justice, and the National Council for
Occupational Safety and Health.
For example, NIOSH commented in its prepared written hearing
testimony:
OSHA has appropriately identified and documented all critical
health effects associated with occupational exposure to beryllium
and has appropriately focused its greatest attention on beryllium
sensitization (BeS), chronic beryllium disease (CBD) and lung cancer
. . .
NIOSH went on to say that sensitization was more than a test result
with little meaning. It relates to a condition in which the immune
system is able to recognize and adversely react to beryllium in a way
that increases the risk of developing CBD. NIOSH agrees with OSHA that
sensitization is a functional change that is necessary in order to
proceed along the pathogenesis to serious lung disease.
The National Safety Council, a congressionally chartered nonprofit
safety organization, also stated that "beryllium represents a serious
health threat resulting from acute or chronic exposures." (Document ID
1612, p. 5). Representative Robert C. "Bobby" Scott, Ranking Member
of Committee on Education and the Workforce, the U.S. House of
Representatives, submitted a statement recognizing that the evidence
strongly supports the conclusion that sensitization can occur from
exposure to soluble and poorly soluble forms of beryllium (Document ID
1672, p. 3).
OSHA also received supporting statements from ATS and ORCHSE on the
inclusion of beryllium sensitization, CBD, skin disease, and lung
cancer as major adverse health effects associated with beryllium
exposure (Document ID 1688, p. 7; 1691, p. 14). ATS specifically
stated:
. . . the ATS supports the inclusion of beryllium sensitization,
CBD, and skin disease as the major adverse health effects associated
with exposure to beryllium at or below 0.1 μg/m3\ and acute
beryllium disease at higher exposures based on the currently
available epidemiologic and experimental studies. (Document ID 1688,
p. 2)
In addition, OSHA received supporting comments from labor organizations
representing workers exposed to beryllium. The AFL-CIO, NABTU, and USW
submitted comments supporting the inclusion of beryllium sensitization,
CBD and lung cancer as health effects from beryllium exposure (Document
ID 1689, pp. 1, 3; 1679, p. 6; 1681, p. 19). AFL-CIO commented that
"[t]he proposal is based on extensive scientific and medical evidence
. . ." and "[b]eryllium exposure causes immunological sensitivity,
CBD and lung cancer. These health effects are debilitating, progressive
and irreversible. Workers are exposed to beryllium through respiratory,
dermal and gastrointestinal routes." (Document ID 1689, pp. 1, 3).
Comments submitted by USW state that "OSHA has correctly identified,
and comprehensively documented the material impairments of health
resulting from beryllium exposure." (Document ID 1681, p. 19).
Dr. Lisa Maier and Ms. Margaret Mroz of National Jewish Health
testified about the health effects of beryllium in support of the
beryllium standard:
We know that chronic beryllium disease often will not manifest
clinically until irreversible lung scarring has occurred, often
years after exposure, with a latency of 20 to 30 years as discussed
yesterday. Much too late to make changes in the work place. We need
to look for early markers of health effects, cast the net widely to
identify cases of sensitization and disease, and use screening
results in concert with exposure sampling to identify areas of
increased risk that can be modified in the work place. (Document ID
1756, Tr. 102; 1806).
American Association for Justice noted that:
Unlike many toxins, there is no threshold below which no worker
will become sensitized to beryllium. Worker sensitization to
beryllium is a precursor to CBD, but not cancer. The symptoms of
chronic beryllium disease (CBD) are part of a continuum of disease
that is progressive in nature. Early recognition of and treatment
for CBD may lead to a lessening of symptoms and may prevent the
disease from progressing further. Symptoms of CBD may occur at
exposure levels well below the proposed permissible exposure limit
of .2 µg/m3\ and even below the action level of .1 µg/
m3\. OSHA has clear authority to regulate health effects across the
entire continuum of disease to protect workers. We applaud OSHA for
proposing to do so. (Document ID 1683, pp. 1-2).
National Committee for Occupational Safety and Health support OSHA
findings of health effects due to beryllium exposure (1690, p. 1).
Comments from Public Citizen also support OSHA findings: "Beryllium is
toxic at extremely low levels and exposure can result in BeS, an immune
response that eventually can lead to an autoimmune granulomatous lung
disease known as CBD. BeS is a necessary prerequisite to the
development of CBD, with OSHA's
NPRM citing studies showing that 31-49 percent of all sensitized
workers were diagnosed with CBD after clinical evaluations. Beryllium
also is a recognized carcinogen that can cause lung cancer." (Document
ID 1670, p.2).
In addition to the comments above and those noted throughout this
Health Effects section, Materion submitted their correspondence to the
National Academies (NAS) regarding the company's assessment of the NAS
beryllium studies and their correspondence to NIOSH regarding the
Cummings 2009 study (Document 1662, Attachments) to OSHA. For the NAS
study, Materion included a series of comments regarding studies
included in the NAS report. OSHA has reviewed these comments and found
that the comments submitted to the NAS critiquing their review of the
health effects of beryllium were considered and incorporated where
appropriate. For the NIOSH study Materion included comments regarding 2
cases of acute beryllium disease evaluated in a study published by
Cummings et al., 2009. NIOSH also dealt with the comments from Materion
as they found appropriate. However, none of the changes recommended by
Materion to the NAS or NIOSH altered the overall findings or
conclusions from either study. OSHA has taken the Materion comments
into account in the review of these documents. OSHA found them not to
be sufficient to discount either the findings of the NAS or NIOSH.
Introduction
Beryllium-associated health effects, including acute beryllium
disease (ABD), beryllium sensitization (also referred to in this
preamble as "sensitization"), chronic beryllium disease (CBD), and
lung cancer, can lead to a number of highly debilitating and life-
altering conditions including pneumonitis, loss of lung capacity
(reduction in pulmonary function leading to pulmonary dysfunction),
loss of physical capacity associated with reduced lung capacity,
systemic effects related to pulmonary dysfunction, and decreased life
expectancy (NIOSH, 1972, Document ID 1324, 1325, 1326, 1327, 1328;
NIOSH, 2011 (0544)).
This Health Effects section presents information on beryllium and
its compounds, the fate of beryllium in the body, research that relates
to its toxic mechanisms of action, and the scientific literature on the
adverse health effects associated with beryllium exposure, including
ABD, sensitization, CBD, and lung cancer. OSHA considers CBD to be a
progressive illness with a continuous spectrum of symptoms ranging from
no symptomatology at its earliest stage following sensitization to mild
symptoms such as a slight almost imperceptible shortness of breath, to
loss of pulmonary function, debilitating lung disease, and, in many
cases, death. This section also discusses the nature of these
illnesses, the scientific evidence that they are causally associated
with occupational exposure to beryllium, and the probable mechanisms of
action with a more thorough review of the supporting studies.
A. Beryllium and Beryllium Compounds--Particle Characterization
1. Particle Physical/Chemical Properties
Beryllium has two oxidative states: Be(0) and Be(2\+\) (Agency for
Toxic Substance and Disease Registry (ATSDR) 2002, Document ID 1371).
It is likely that the Be(2\+\) state is the most biologically reactive
and able to form a bond with peptides leading to it becoming antigenic
(Snyder et al., 2003) as discussed in more detail in the Beryllium
Sensitization section below. Beryllium has a high charge-to-radius
ratio, forming various types of ionic bonds. In addition, beryllium has
a strong tendency for covalent bond formation (e.g., it can form
organometallic compounds such as Be(CH3)2 and
many other complexes) (ATSDR, 2002, Document ID 1371; Greene et al.,
1998 (1519)). However, it appears that few, if any, toxicity studies
exist for the organometallic compounds. Additional physical/chemical
properties, such as solubility, for beryllium compounds that may be
important in their biological response are summarized in Table 1 below.
Solubility (as discussed in biological fluids in Section V.A.2.A below)
is an important factor in evaluating the biological response to
beryllium. For comparative purposes, water solubility is used in Table
1. The International Chemical Safety Cards lists water solubility as a
way to standardize solubility values among particles and fibers. The
information contained within Table 1 was obtained from the
International Chemical Safety Cards (ICSC) for beryllium metal (ICSC
0226, Document ID 0438), beryllium oxide (ICSC 1325, Document ID 0444),
beryllium sulfate (ICSC 1351, Document ID 0443), beryllium nitrate
(ICSC 1352, Document ID 0442), beryllium carbonate (ICSC 1353, Document
ID 0441), beryllium chloride (ICSC 1354, Document ID 0440), beryllium
fluoride (ICSC 1355, Document ID 0439) and from the hazardous substance
data bank (HSDB) for beryllium hydroxide (CASRN: 13327-32-7), and
beryllium phosphate (CASRN: 13598-15-7, Document ID 0533). Additional
information on chemical and physical properties as well as industrial
uses for beryllium can be found in this preamble at Section IV,
Chemical Properties and Industrial Uses.
Table 1--Beryllium Characteristics and Properties
----------------------------------------------------------------------------------------------------------------
Solubility in
Compound name Chemical formula Molecular Acute physical water at 20
mass hazards [deg]C
----------------------------------------------------------------------------------------------------------------
Beryllium Metal.............. Be............................ 9.0 Combustible; Finely None.
dispersed
particles--Explosi
ve.
Beryllium Oxide.............. BeO........................... 25.0 Not combustible or Very sparingly
explosive. soluble.
Beryllium Carbonate.......... Be2CO3(OH)/Be2CO5 H2.......... 181.07 Not combustible or None.
explosive.
Beryllium Sulfate............ BeSO4......................... 105.1 Not combustible or Slightly
explosive. soluble.
Beryllium Nitrate............ BeN2O6/Be(NO3)2............... 133.0 Enhances combustion Very soluble
of other (1.66 x 106
substances. mg/L).
Beryllium Hydroxide.......... Be(OH)2....................... 43.0 Not reported....... Slightly
soluble 0.8 x
10\-4\ mol/L
(3.44 mg/L).
Beryllium Chloride........... BeCl2......................... 79.9 Not combustible or Soluble.
explosive.
Beryllium Fluoride........... BeF2.......................... 47.0 Not combustible or Very soluble.
explosive.
Beryllium Phosphate.......... Be3(PO4)2..................... 271.0 Not reported....... Soluble.
----------------------------------------------------------------------------------------------------------------
Beryllium shows a high affinity for oxygen in air and water,
resulting in a thin surface film of beryllium oxide on the bare metal.
If the surface film is disturbed, it may become airborne and cause
respiratory tract exposure or dermal exposure (also referred to as
dermal contact). The physical properties of solubility, particle
surface area, and particle size of some beryllium compounds are
examined in more detail below. These properties have been evaluated in
many toxicological studies. In particular, the properties related to
the calcination (firing temperatures) and differences in crystal size
and solubility are important aspects in their toxicological profile.
2. Factors Affecting Potency and Effect of Beryllium Exposure
The effect and potency of beryllium and its compounds, as for any
toxicant, immunogen, or immunotoxicant, may be dependent upon the
physical state in which they are presented to a host. For occupational
airborne materials and surface contaminants, it is especially critical
to understand those physical parameters in order to determine the
extent of exposure to the respiratory tract and skin since these are
generally the initial target organs for either route of exposure.
For example, solubility has an important part in determining the
toxicity and bioavailability of airborne materials as well. Respiratory
tract retention and skin penetration are directly influenced by the
solubility and reactivity of airborne material. Large particles may
have less of an effect in the lung than smaller particles due to
reduced potential to stay airborne, to be inhaled, or be deposited
along the respiratory tract. In addition, once inhalation occurs
particle size is critical in determining where the particle will
deposit along the respiratory tract.
These factors may be responsible, at least in part, for the process
by which beryllium sensitization progresses to CBD in exposed workers.
Other factors influencing beryllium-induced toxicity include the
surface area of beryllium particles and their persistence in the lung.
With respect to dermal contact or exposure, the physical
characteristics of the particle are also important since they can
influence skin absorption and bioavailability. This section addresses
certain physical characteristics (i.e., solubility, particle size,
particle surface area) that influence the toxicity of beryllium
materials in occupational settings.
a. Solubility
Solubility has been shown to be an important determinant of the
toxicity of airborne materials, influencing the deposition and
persistence of inhaled particles in the respiratory tract, their
bioavailability, and the likelihood of presentation to the immune
system. A number of chemical agents, including metals that contact and
penetrate the skin, are able to induce an immune response, such as
sensitization (Boeniger, 2003, Document ID 1560; Mandervelt et al.,
1997 (1451)). Similar to inhaled agents, the ability of materials to
penetrate the skin is also influenced by solubility because dermal
absorption may occur at a greater rate for soluble materials than
poorly soluble materials (Kimber et al., 2011, Document ID 0534). In
post-hearing comments, NIOSH explained:
In biological systems, solubility is used to describe the rate
at which a material will undergo chemical clearance and dissolve in
a fluid (airway lining, inside phagolysomes) relative to the rate of
mechanical clearance. For example, in the lung a "poorly soluble"
material is one that dissolves at a rate slower than the rate of
mechanical removal via the mucociliary escalator. Examples of poorly
soluble forms of beryllium are beryllium silicates, beryllium oxide,
and beryllium metal and alloys (Deubner et al. 2011; Huang et al.
2011; Duling et al. 2012; Stefaniak et al. 2006, 201la, 2012). A
highly soluble material is one that dissolves at a rate faster than
mechanical clearance. Examples of highly soluble forms of beryllium
are beryllium fluoride, beryllium sulfate, and beryllium chloride.
(Document ID 1660-A2, p. 9).
This section reviews the relevant information regarding solubility, its
importance in a biological matrix and its relevance to sensitization
and beryllium lung disease. The weight of evidence presented below
suggests that both soluble and poorly soluble forms of beryllium can
induce a sensitization response and result in progression of lung
disease.
Beryllium salts, including the chloride (BeCl2),
fluoride (BeF2), nitrate (Be(NO3)2),
phosphate (Be3 (PO4)2), and sulfate
(tetrahydrate) (BeSO4 [middot] 4H2O) salts, are
all water soluble. However, soluble beryllium salts can be converted to
less soluble forms in the lung (Reeves and Vorwald, 1967, Document ID
1309). According to an EPA report, aqueous solutions of the soluble
beryllium salts are acidic as a result of the formation of
Be(OH2)4 2\+\, the tetrahydrate, which will react
to form poorly soluble hydroxides or hydrated complexes within the
general physiological range of pH values (between 5 and 8) (EPA, 1998,
Document ID 1322). This may be an important factor in the development
of CBD since lower-soluble forms of beryllium have been shown to
persist in the lung for longer periods of time and persistence in the
lung may be needed in order for this disease to occur (NAS, 2008,
Document ID 1355).
Beryllium oxide (BeO), hydroxide (Be(OH)2), carbonate
(Be2 CO3 (OH)2), and sulfate
(anhydrous) (BeSO4) are either insoluble, slightly soluble,
or considered to be sparingly or poorly soluble (almost insoluble or
having an extremely slow rate of dissolution and most often referred to
as poorly soluble in more recent literature). The solubility of
beryllium oxide, which is prepared from beryllium hydroxide by
calcining (heating to a high temperature without fusing in order to
drive off volatile chemicals) at temperatures between 500 and 1,750
[deg]C, has an inverse relationship with calcination temperature.
Although the solubility of the low-fired crystals can be as much as 10
times that of the high-fired crystals, low-fired beryllium oxide is
still only sparingly soluble (Delic, 1992, Document 1547). In a study
that measured the dissolution kinetics (rate to dissolve) of beryllium
compounds calcined at different temperatures, Hoover et al., compared
beryllium metal to beryllium oxide particles and found them to have
similar solubilities. This was attributed to a fine layer of beryllium
oxide that coats the metal particles (Hoover et al., 1989, Document ID
1510). A study conducted by Deubner et al. (2011) determined ore
materials to be more soluble than beryllium oxide at pH 7.2 but similar
in solubility at pH 4.5. Beryllium hydroxide was more soluble than
beryllium oxide at both pHs (Deubner et al., 2011, Document ID 0527).
Investigators have also attempted to determine how biological
fluids can dissolve beryllium materials. In two studies, poorly soluble
beryllium, taken up by activated phagocytes, was shown to be ionized by
myeloperoxidases (Leonard and Lauwerys, 1987, Document ID 1293;
Lansdown, 1995 (1469)). The positive charge resulting from ionization
enabled the beryllium to bind to receptors on the surface of cells such
as lymphocytes or antigen-presenting cells which could make it more
biologically active (NAS, 2008, Document ID 1355). In a study utilizing
phagolysosomal-simulating fluid (PSF) with a pH of 4.5, both beryllium
metal and beryllium oxide dissolved at a greater rate than that
previously reported in water or SUF (simulant fluid) (Stefaniak et al.,
2006, Document ID 1398), and the rate of dissolution of the multi-
constituent (mixed) particles
was greater than that of the single-constituent beryllium oxide powder.
The authors speculated that copper in the particles rapidly dissolves,
exposing the small inclusions of beryllium oxide, which have higher
specific surface areas (SSA) and therefore dissolve at a higher rate. A
follow-up study by the same investigational team (Duling et al., 2012,
Document ID 0539) confirmed dissolution of beryllium oxide by PSF and
determined the release rate was biphasic (initial rapid diffusion
followed by a latter slower surface reaction-driven release). During
the latter phase, dissolution half-times were 1,400 to 2,000 days. The
authors speculated this indicated bertrandite was persistent in the
lung (Duling et al., 2012, Document ID 0539).
In a recent study investigating the dissolution and release of
beryllium ions for 17 beryllium-containing materials (ore, hydroxide,
metal, oxide, alloys, and processing intermediates) using artificial
human airway epithelial lining fluid, Stefaniak et al. (2011) found
release of beryllium ions within 7 days (beryl ore smelter dust). The
authors calculated dissolution half-times ranging from 30 days
(reduction furnace material) to 74,000 days (hydroxide). Stefaniak et
al. (2011) speculated that despite the rapid mechanical clearance,
billions of beryllium ions could be released in the respiratory tract
via dissolution in airway lining fluid (ALF). Under this scenario,
beryllium-containing particles depositing in the respiratory tract
dissolving in ALF could provide beryllium ions for absorption in the
lung and interact with immune cells in the respiratory tract (Stefaniak
et al., 2011, Document ID 0537).
Huang et al. (2011) investigated the effect of simulated lung fluid
(SLF) on dissolution and nanoparticle generation and beryllium-
containing materials. Bertrandite-containing ore, beryl-containing ore,
frit (a processing intermediate), beryllium hydroxide (a processing
intermediate) and silica (used as a control), were equilibrated in SLF
at two pH values (4.5 and 7.2) to reflect inter- and intra-cellular
environments in the lung tissue. Concentrations of beryllium, aluminum,
and silica ions increased linearly during the first 20 days in SLF, and
rose more slowly thereafter, reaching equilibrium over time. The study
also found nanoparticle formation (in the size range of 10-100 nm) for
all materials (Huang et al., 2011, Document ID 0531).
In an in vitro skin model, Sutton et al. (2003) demonstrated the
dissolution of beryllium compounds (poorly soluble beryllium hydroxide,
soluble beryllium phosphate) in a simulated sweat fluid (Document ID
1393). This model showed beryllium can be dissolved in biological
fluids and be available for cellular uptake in the skin. Duling et al.
(2012) confirmed dissolution and release of ions from bertrandite ore
in an artificial sweat model (pH 5.3 and pH 6.5) (Document ID 0539).
In summary, studies have shown that soluble forms of beryllium
readily dissolve into ionic components making them biologically
available for dermal penetration and activation of immune cells
(Stefaniak et al., 2011; Document ID 0537). Soluble forms can also be
converted to less soluble forms in the lung (Reeves and Vorwald, 1967,
Document ID 1309) making persistence in the lung a possibility and
increasing the potential for development of CBD (see section V.D.2).
Studies by Stefaniak et al. (2003, 2006, 2011, 2012) (Document ID 1347;
1398; 0537; 0469), Huang et al. (2011), Duling et al. (2012), and
Deubner et al. (2011) have demonstrated poorly soluble forms can be
readily dissolved in biological fluids such as sweat, lung fluid, and
cellular fluids. The dissolution of beryllium ions into biological
fluids increases the likelihood of beryllium presentation to immune
cells, thus increasing the potential for sensitization through dermal
contact or lung exposure (Document ID 0531; 0539; 0527) (see section
V.D.1).
OSHA received comments from the Non-Ferrous Founders' Society
(NFFS) contending that the scientific evidence does not support
insoluble beryllium as a causative agent for sensitization and CBD
(Document ID 1678, p. 6). The NFFS contends that insoluble beryllium is
not carcinogenic or a sensitizer to humans, and argues that based on
this information, OSHA should consider a bifurcated standard with
separate PELs for soluble and poorly soluble beryllium and beryllium
compounds and insoluble beryllium metallics (Document ID 1678, p. 7).
As evidence supporting its conclusion, the NFFS cited a 2010 statement
written by Dr. Christian Strupp commissioned by the beryllium industry
(Document ID 1785, 1814), which reviewed selected studies to evaluate
the toxic potential of beryllium metal and alloys (Document ID 1678,
pp. 7). The Strupp and Furnes statement (2010) cited by the NFFS is the
background material and basis of the Strupp (2011a and 2011b) studies
in the docket (Document ID 1794; 1795). In response to Strupp 2011 (a
and b), Aleks Stefaniak of NIOSH published a letter to the editor
refuting some of the evidence presented by Strupp (2011a and b,
Document ID 1794; 1795). The first study by Strupp (2011a) evaluated
selected animal studies and concluded that beryllium metal was not a
sensitizer. Stefaniak (2011) evaluated the validity of the Strupp
(2011a) study of beryllium toxicity and noted numerous deficiencies,
including deficiencies in the study design, improper administration of
beryllium test compounds, and lack of proper controls (Document ID
1793). In addition, Strupp (2011a) omitted numerous key animal and
epidemiological studies demonstrating the potential of poorly soluble
beryllium and beryllium metal as a sensitizing agent. One such study,
Tinkle et al. (2003), demonstrated that topical application of poorly
soluble beryllium induced skin sensitization in mice (Document ID
1483). Comments from NIOSH and National Jewish Medical Center state
that poorly soluble beryllium materials are capable of dissolving in
sweat (Document ID 1755; 1756). After evaluating the scientific
evidence from epidemiological and animal studies, OSHA finds, based on
the best available evidence, that soluble and poorly soluble forms of
beryllium and beryllium compounds are causative agents of sensitization
and CBD.
b. Particle Size
The toxicity of beryllium as exemplified by beryllium oxide is
dependent, in part, on the particle size, with smaller particles (less
than 10 μm in diameter) able to penetrate beyond the larynx
(Stefaniak et al., 2008, Document ID 1397). Most inhalation studies and
occupational exposures involve quite small (less than 1-2 μm in
diameter) beryllium oxide particles that can penetrate to the pulmonary
regions of the lung (Stefaniak et al., 2008, Document ID 1397). In
inhalation studies with beryllium ores, particle sizes are generally
much larger, with deposition occurring in several areas throughout the
respiratory tract for particles less than 10 μm in diameter.
The temperature at which beryllium oxide is calcined influences its
particle size, surface area, solubility, and ultimately its toxicity
(Delic, 1992, Document ID 1547). Low-fired (500 [deg]C) beryllium oxide
is predominantly made up of poorly crystallized small particles, while
higher firing temperatures (1000-1750 [deg]C) result in larger particle
sizes (Delic, 1992, Document ID 1547).
In order to determine the extent to which particle size plays a
role in the toxicity of beryllium in occupational settings, several key
studies are reviewed and detailed below. The findings on particle size
have been related, where possible, to work process
and biologically relevant toxicity endpoints of either sensitization or
CBD.
Numerous studies have been conducted evaluating the particle size
generated during basic industrial and machining operations. In a study
by Cohen et al. (1983), a multi-cyclone sampler was utilized to measure
the size mass distribution of the beryllium aerosol at a beryllium-
copper alloy casting operation (Document ID 0540). Briefly, Cohen et
al. (1983) found variable particle size generation based on the
operations being sampled with particle size ranging from 3 to 16 μm.
Hoover et al. (1990) also found variable particle sizes being generated
across different operations (Document ID 1314). In general, Hoover et
al. (1990) found that milling operations generated smaller particle
sizes than sawing operations. Hoover et al. (1990) also found that
beryllium metal generated higher concentrations than metal alloys.
Martyny et al. (2000) characterized generation of particle size during
precision beryllium machining processes (Document ID 1053). The study
found that more than 50 percent of the beryllium machining particles
collected in the breathing zone of machinists were less than 10 μm
in aerodynamic diameter with 30 percent of those smaller particles
being less than 0.6 μm. A study by Thorat et al. (2003) found
similar results with ore mixing, crushing, powder production and
machining ranging from 5.0 to 9.5 μm (Document ID 1389). Kent et al.
(2001) measured airborne beryllium using size-selective samplers in
five furnace areas at a beryllium processing facility (Document ID
1361). A statistically significant linear trend was reported between
the alveolar-deposited particle mass concentration and prevalence of
CBD and sensitization in the furnace production areas. The study
authors suggested that the concentration of alveolar-deposited
particles (e.g., <3.5 μm) may be a better predictor of sensitization
and CBD than the total mass concentration of airborne beryllium.
A recent study by Virji et al. (2011) evaluated particle size
distribution, chemistry, and solubility in areas with historically
elevated risk of sensitization and CBD at a beryllium metal powder,
beryllium oxide, and alloy production facility (Document ID 0465). The
investigators observed that historically, exposure-response
relationships have been inconsistent when using mass concentration to
identify process-related risk, possibly due to incomplete particle
characterization. Two separate exposure surveys were conducted in March
1999 and June-August 1999 using multi-stage personal impactor samplers
(to determine particle size distribution) and personal 37 mm closed
face cassette (CFC) samplers, both located in workers' breathing zones.
One hundred and ninety eight time-weighted-average (TWA) personal
impactor samples were analyzed for representative jobs and processes. A
total of 4,026 CFC samples were collected over the collection period
and analyzed for mass concentration, particle size, chemical content
and solubility and compared to process areas with high risk of
sensitization and CBD. The investigators found that total beryllium
concentration varied greatly between workers and among process areas.
Analysis of chemical form and solubility also revealed wide variability
among process areas, but high risk process areas had exposures to both
soluble and poorly soluble forms of beryllium. Analysis of particle
size revealed most process areas had particles ranging from 5 to 14
µm mass median aerodynamic diameter (MMAD). Rank order
correlating jobs to particle size showed high overall consistency
(Spearman r = 0.84) but moderate correlation (Pearson r = 0.43). The
investigators concluded that by considering more relevant aspects of
exposure such as particle size distribution, chemical form, and
solubility could potentially improve exposure assessments (Virji et
al., 2011, Document ID 0465).
To summarize, particle size influences deposition of beryllium
particles in the lung, thereby influencing toxicity. Studies by
Stefaniak et al. (2008) demonstrated that the majority of particles
generated by beryllium processing operations were in the respirable
range (less than 1-2 μm) (Document ID 1397). However, studies by
Virji et al. (2011) (Document ID 0465), Cohen et al. (1983) (Document
ID 0540) and Hoover et al. (1990) (Document ID 1314) showed that some
operations could generate particle sizes ranging from 3 to 16 μm.
c. Particle Surface Area
Particle surface area has been postulated as an important metric
for beryllium exposure. Several studies have demonstrated a
relationship between the inflammatory and tumorigenic potential of
ultrafine particles and their increased surface area (Driscoll, 1996,
Document ID 1539; Miller, 1995 (0523); Oberdorster et al., 1996
(1434)). While the exact mechanism explaining how particle surface area
influences its biological activity is not known, a greater particle
surface area has been shown to increase inflammation, cytokine
production, pro- and anti-oxidant defenses and apoptosis, which has
been shown to increase the tumorigenic potential of poorly-soluble
particles (Elder et al., 2005, Document ID 1537; Carter et al., 2006
(1556); Refsnes et al., 2006 (1428)).
Finch et al. (1988) found that beryllium oxide calcined at
500[deg]C had 3.3 times greater specific surface area (SSA) than
beryllium oxide calcined at 1000 [deg]C, although there was no
difference in size or structure of the particles as a function of
calcining temperature (Document ID 1317). The beryllium-metal aerosol
(airborne beryllium particles), although similar to the beryllium oxide
aerosols in aerodynamic size, had an SSA about 30 percent that of the
beryllium oxide calcined at 1000 [deg]C. As discussed above, a later
study by Delic (1992) found calcining temperatures had an effect on SSA
as well as particle size (Document ID 1547).
Several studies have investigated the lung toxicity of beryllium
oxide calcined at different temperatures and generally have found that
those calcined at lower temperatures have greater toxicity and effect
than materials calcined at higher temperatures. This may be because
beryllium oxide fired at the lower temperature has a loosely formed
crystalline structure with greater specific surface area than the fused
crystal structure of beryllium oxide fired at the higher temperature.
For example, beryllium oxide calcined at 500 [deg]C has been found to
have stronger pathogenic effects than material calcined at 1,000
[deg]C, as shown in several of the beagle dog, rat, mouse and guinea
pig studies discussed in the section on CBD pathogenesis that follows
(Finch et al., 1988, Document ID 1495; Pol[aacute]k et al., 1968
(1431); Haley et al., 1989 (1366); Haley et al., 1992 (1365); Hall et
al., 1950 (1494)). Finch et al. have also observed higher toxicity of
beryllium oxide calcined at 500 [deg]C, an observation they attribute
to the greater surface area of beryllium particles calcined at the
lower temperature (Finch et al., 1988, Document ID 1495). These authors
found that the in vitro cytotoxicity to Chinese hamster ovary (CHO)
cells and cultured lung epithelial cells of 500 [deg]C beryllium oxide
was greater than that of 1,000 [deg]C beryllium oxide, which in turn
was greater than that of beryllium metal. However, when toxicity was
expressed in terms of particle surface area, the cytotoxicity of all
three forms was similar. Similar results were observed in a study
comparing the cytotoxicity of beryllium metal particles of various
sizes to cultured rat alveolar macrophages, although specific surface
area did not entirely predict cytotoxicity (Finch et al., 1991,
Document ID 1535).
Stefaniak et al. (2003) investigated the particle structure and
surface area of beryllium metal, beryllium oxide, and copper-beryllium
alloy particles (Document ID 1347). Each of these samples was separated
by aerodynamic size, and their chemical compositions and structures
were determined with x-ray diffraction and transmission electron
microscopy, respectively. In summary, beryllium-metal powder varied
remarkably from beryllium oxide powder and alloy particles. The metal
powder consisted of compact particles, in which SSA decreases with
increasing surface diameter. In contrast, the alloys and oxides
consisted of small primary particles in clusters, in which the SSA
remains fairly constant with particle size. SSA for the metal powders
varied based on production and manufacturing process with variations
among samples as high as a factor of 37. Stefaniak et al. (2003) found
lesser variation in SSA for the alloys or oxides (Document ID 1347).
This is consistent with data from other studies summarized above
showing that process may affect particle size and surface area.
Particle size and/or surface area may explain differences in the rate
of beryllium sensitization and CBD observed in some epidemiological
studies. However, these properties have not been consistently
characterized in most studies.
B. Kinetics and Metabolism of Beryllium
Beryllium enters the body by inhalation, absorption through the
skin, or ingestion. For occupational exposure, the airways and the skin
are the primary routes of uptake.
1. Exposure Via the Respiratory System
The respiratory tract, especially the lung, is the primary target
of inhalation exposure in workers. Disposition (deposition and
clearance) of the particle or droplet along the respiratory tract
influences the biological response to the toxicant (Schlesinger et al.,
1997, Document ID 1290). Inhaled beryllium particles are deposited
along the respiratory tract in a size dependent manner as described by
the International Commission for radiological Protection (ICRP) model
(Figure 1). In general, particles larger than 10 μm tend to deposit
in the upper respiratory tract or nasal region and do not appreciably
penetrate lower in the tracheobronchial or pulmonary regions (Figure
1). Particles less than 10 μm increasingly penetrate and deposit in
the tracheobronchial and pulmonary regions with peak deposition in the
pulmonary region occurring below 5 μm in particle diameter. The CBD
pathology of concern is found in the pulmonary region. For particles
below 1 μm in particle diameter, regional deposition changes
dramatically. Ultrafine particles (generally considered to be 100 nm or
lower) have a higher rate of deposition along the entire respiratory
system (ICRP model, 1994). However, due to the hygroscopic nature of
soluble particles, deposition patterns may be slightly different with
an enhanced preference for the tracheobronchial or bronchial region of
the lung. Nonetheless, soluble particles are still capable of
depositing in the pulmonary region (Schlesinger et al., 1997, Document
ID 1290).
Particles depositing in the lung and along the entire respiratory
tract may encounter immunologic cells or may move into the vascular
system where they are free to leave the lung and can contribute to
systemic beryllium concentrations.
[GRAPHIC] [TIFF OMITTED] TR09JA17.000
Beryllium is removed from the respiratory tract by various
clearance mechanisms. Soluble beryllium is removed from the respiratory
tract via absorption or chemical clearance (Schlesinger, 1997, Document
ID 1290). Sparingly soluble or poorly soluble beryllium is removed via
mechanical mechanisms and may remain in the
lungs for many years after exposure, as has been observed in workers
(Schepers, 1962, Document ID 1414). Clearance mechanisms for sparingly
soluble or poorly soluble beryllium particles include: In the nasal
passage, sneezing, mucociliary transport to the throat, or dissolution;
in the tracheobronchial region, mucociliary transport, coughing,
phagocytosis, or dissolution; in the pulmonary or alveolar region,
phagocytosis, movement through the interstitium (translocation), or
dissolution (Schlesinger, 1997, Document ID 1290). Mechanical clearance
mechanisms may occur slowly in humans, which is consistent with some
animal and human studies. For example, subjects in the Beryllium Case
Registry (BCR), which identifies and tracks cases of acute and chronic
beryllium diseases, had elevated concentrations of beryllium in lung
tissue (e.g., 3.1 μg/g of dried lung tissue and 8.5 μg/g in a
mediastinal node) more than 20 years after termination of short-term
(generally between 2 and 5 years) occupational exposure to beryllium
(Sprince et al., 1976, Document ID 1405).
Due to physiological differences, clearance rates can vary between
humans and animal species (Schlesinger, 1997, Document ID 1290; Miller,
2000 (1831)). However, clearance rates are also dependent upon the
solubility, dose, and size of the inhaled beryllium compound. As
reviewed in a WHO Report (2001) (Document ID 1282), more soluble
beryllium compounds generally tend to be cleared from the respiratory
system and absorbed into the bloodstream more rapidly than less soluble
compounds (Van Cleave and Kaylor, 1955, Document ID 1287; Hart et al.,
1980 (1493); Finch et al., 1990 (1318)). Animal inhalation or
intratracheal instillation studies administering soluble beryllium
salts demonstrated significant absorption of approximately 20 percent
of the initial lung burden with rapid dissolution of soluble compounds
from the lung (Delic, 1992, Document ID 1547). Absorption of poorly
soluble compounds such as beryllium oxide administered via inhalation
or intratracheal instillation was slower and less significant (Delic,
1992, Document ID 1547). Additional animal studies have demonstrated
that clearance of poorly soluble beryllium compounds was biphasic: A
more rapid initial mucociliary transport phase of particles from the
tracheobronchial tree to the gastrointestinal tract, followed by a
slower phase via translocation to tracheobronchial lymph nodes,
alveolar macrophages uptake, and beryllium particles dissolution
(Camner et al., 1977, Document ID 1558; Sanders et al., 1978 (1485);
Delic, 1992 (1547); WHO, 2001 (1282)). Confirmatory studies in rats
have shown the half-time for the rapid phase to be between 1 and 60
days, while the slow phase ranged from 0.6 to 2.3 years. Studies have
also shown that this process was influenced by the solubility of the
beryllium compounds: Weeks/months for soluble compounds, months/years
for poorly soluble compounds (Reeves and Vorwald, 1967; Reeves et al.,
1967; Rhoads and Sanders, 1985). Studies in guinea pigs and rats
indicate that 40-50 percent of the inhaled soluble beryllium salts are
retained in the respiratory tract. Similar data could not be found for
the poorly soluble beryllium compounds or metal administered by this
exposure route. (WHO, 2001, Document ID 1282; ATSDR, 2002 (1371).)
Evidence from animal studies suggests that greater amounts of
beryllium deposited in the lung may result in slower clearance times.
Acute inhalation studies performed in rats and mice using a single dose
of inhaled aerosolized beryllium metal showed that exposure to
beryllium metal can slow particle clearance and induce lung damage in
rats and mice (Finch et al., 1998, Document ID 1317; Haley et al., 1990
(1314)). In another study, Finch et al. (1994) exposed male F344/N rats
to beryllium metal at concentrations resulting in beryllium lung
burdens of 1.8, 10, and 100 μg. These exposure levels resulted in an
estimated clearance half-life ranging from 250 to 380 days for the
three concentrations. For mice (Finch et al., 1998, Document ID 1317),
lung clearance half-lives were 91-150 days (for 1.7- and 2.6-μg lung
burden groups) or 360-400 days (for 12- and 34-μg lung burden
groups). While the lower exposure groups were quite different for rats
and mice, the highest groups were similar in clearance half-lives for
both species.
Beryllium absorbed from the respiratory system was shown to
distribute primarily to the tracheobronchial lymph nodes via the lymph
system, bloodstream, and skeleton (Stokinger et al., 1953, Document ID
1277; Clary et al., 1975 (1320); Sanders et al., 1975 (1486); Finch et
al., 1990 (1318)). Studies in rats demonstrated accumulation of
beryllium chloride in the skeletal system following intraperitoneal
injection (Crowley et al., 1949, Document ID 1551; Scott et al., 1950
(1413)) and accumulation of beryllium phosphate and beryllium sulfate
in both non-parenchymal and parenchymal cells of the liver after
intravenous administration in rats (Skilleter and Price, 1978, Document
ID 1408). Studies have also demonstrated intracellular accumulation of
beryllium oxide in bone marrow throughout the skeletal system after
intravenous administration to rabbits (Fodor, 1977, Document ID 1532;
WHO, 2001 (1282)). Trace amounts of beryllium have also been shown to
be distributed throughout the body (WHO, 2001, Document ID 1282).
Systemic distribution of the more soluble compounds was shown to be
greater than that of the poorly soluble compounds (Stokinger et al.,
1953, Document ID 1277). Distribution has also been shown to be dose
dependent in research using intravenous administration of beryllium in
rats; small doses were preferentially taken up in the skeleton, while
higher doses were initially distributed preferentially to the liver.
Beryllium was later mobilized from the liver and transferred to the
skeleton (IARC, 1993, Document ID 1342). A half-life of 450 days has
been estimated for beryllium in the human skeleton (ICRP, 1960,
Document ID 0248). This indicates the skeleton may serve as a
repository for beryllium that may later be reabsorbed by the
circulatory system, making beryllium available to the immunological
system (WHO, 2001, Document ID 1282). In a recent review of the
information, the American Conference of Governmental Industrial
Hygienists (ACGIH, 2010) was not able to confirm the association
between occupational inhalation and urinary excretion (Document ID
1662, p. 4). However, IARC (2012) noted that an accidental exposure of
25 people to beryllium dust reported in a study by Zorn et al. (1986)
resulted in a mean serum concentration of 3.5 μg/L one day after the
exposure, which decreased to 2.4 μg/L by day six. The IARC report
concluded that beryllium from beryllium metal was biologically
available for systemic distribution from the lung (IARC, 2012, Document
ID 0650).
Based on these studies, OSHA finds that the respiratory tract is a
primary pathway for beryllium exposure. While particle size and surface
area may contribute to the toxicity of beryllium, there is not
sufficient evidence for OSHA to regulate based on size and surface
area. However, the Agency finds that both soluble and poorly soluble
forms of beryllium and beryllium compounds can contribute to exposure
via the respiratory system and therefore can be causative agents of
sensitization and CBD.
2. Dermal Exposure
Beryllium compounds have been shown to cause skin irritation and
sensitization in humans and certain animal models (Van Ordstrand et
al., 1945, Document ID 1383; de Nardi et al., 1953 (1545); Nishimura,
1966 (1435); Epstein, 1991 (0526); Belman, 1969 (1562); Tinkle et al.,
2003 (1483); Delic, 1992 (1547)). The Agency for Toxic Substances and
Disease Registry (ATSDR) estimated that less than 0.1 percent of
beryllium compounds are absorbed through the skin (ATSDR, 2002,
Document ID 1371). However, even minute contact and absorption across
the skin may directly elicit an immunological response resulting in
sensitization (Deubner et al., 2001, Document ID 1543; Toledo et al.,
2011 (0522)). Studies by Tinkle et al. (2003) showed that penetration
of beryllium oxide particles was possible ex vivo for human intact skin
at particle sizes of less than or equal to 1μm in diameter, as
confirmed by scanning electron microscopy (Document ID 1483). Using
confocal microscopy, Tinkle et al. demonstrated that surrogate
fluorescent particles up to 1 μm in size could penetrate the mouse
epidermis and dermis layers in a model designed to mimic the flexing
and stretching of human skin in motion. Other poorly soluble particles,
such as titanium dioxide, have been shown to penetrate normal human
skin (Tan et al., 1996, Document ID 1391) suggesting the flexing and
stretching motion as a plausible mechanism for dermal penetration of
beryllium as well. As earlier summarized, poorly soluble forms of
beryllium can be solubilized in biological fluids (e.g., sweat) making
them available for absorption through intact skin (Sutton et al., 2003,
Document ID 1393; Stefaniak et al., 2011 (0537) and 2014 (0517); Duling
et al., 2012 (0539)).
Although its precise role remains to be elucidated, there is
evidence that dermal exposure can contribute to beryllium
sensitization. As early as the 1940s it was recognized that dermatitis
experienced by workers in primary beryllium production facilities was
linked to exposures to the soluble beryllium salts. Except in cases of
wound contamination, dermatitis was rare in workers whose exposures
were restricted to exposure to poorly soluble beryllium-containing
particles (Van Ordstrand et al., 1945, Document ID 1383). Further
investigation by McCord in 1951 (Document ID 1448) indicated that
direct skin contact with soluble beryllium compounds, but not beryllium
hydroxide or beryllium metal, caused dermal lesions (reddened,
elevated, or fluid-filled lesions on exposed body surfaces) in
susceptible persons. Curtis, in 1951, demonstrated skin sensitization
to beryllium with patch testing using soluble and poorly soluble forms
of beryllium in beryllium-na[iuml]ve subjects. These subjects later
developed granulomatous skin lesions with the classical delayed-type
contact dermatitis following repeat challenge (Curtis, 1951, Document
ID 1273). These lesions appeared after a latent period of 1-2 weeks,
suggesting a delayed allergic reaction. The dermal reaction occurred
more rapidly and in response to smaller amounts of beryllium in those
individuals previously sensitized (Van Ordstrand et al., 1945, Document
ID 1383). Contamination of cuts and scrapes with beryllium can result
in the beryllium becoming embedded within the skin causing an
ulcerating granuloma to develop in the skin (Epstein, 1991, Document ID
0526). Soluble and poorly soluble beryllium-compounds that penetrate
the skin as a result of abrasions or cuts have been shown to result in
chronic ulcerations and skin granulomas (Van Ordstrand et al., 1945,
Document ID 1383; Lederer and Savage, 1954 (1467)). Beryllium
absorption through bruises and cuts has been demonstrated as well
(Rossman et al., 1991, Document ID 1332).
In a study by Ivannikov et al. (1982) (as cited in Deubner et al.,
2001, Document ID 0023), beryllium chloride was applied directly to
three different types of wounded skin: abrasions (superficial skin
trauma), cuts (skin and superficial muscle trauma), and penetration
wounds (deep muscle trauma). According to Deubner et al. (2001) the
percentage of the applied dose systemically absorbed during a 24-hour
exposure was significant, ranging from 7.8 percent to 11.4 percent for
abrasions, from 18.3 percent to 22.9 percent for cuts, and from 34
percent to 38.8 percent for penetration wounds (Deubner et al., 2001,
Document ID 0023).
A study by Deubner et al. (2001) concluded that exposure across
damaged skin can contribute as much systemic loading of beryllium as
inhalation (Deubner et al., 2001, Document ID 1543). Deubner et al.
(2001) estimated dermal loading (amount of particles penetrating into
the skin) in workers as compared to inhalation exposure. Deubner's
calculations assumed a dermal loading rate for beryllium on skin of
0.43 μg/cm2, based on the studies of loading on skin after workers
cleaned up (Sanderson et al.., 1999, Document ID 0474), multiplied by a
factor of 10 to approximate the workplace concentrations and the very
low absorption rate of beryllium into skin of 0.001 percent (taken from
EPA estimates). As cited by Deubner et al. (2001), the EPA noted that
these calculations did not take into account absorption of soluble
beryllium salts that might occur across nasal mucus membranes, which
may result from contact between contaminated skin and the nose (Deubner
et al., 2001, Document ID 1543).
A study conducted by Day et al. (2007) evaluated the effectiveness
of a dermal protection program implemented in a beryllium alloy
facility in 2002 (Document ID 1548). The investigators evaluated levels
of beryllium in air, on workplace surfaces, on cotton gloves worn over
nitrile gloves, and on the necks and faces of workers over a six day
period. The investigators found a strong correlation between air
concentrations determined from sampling data and work surface
contamination at this facility. The investigators also found measurable
levels of beryllium on the skin of workers as a result of work
processes even from workplace areas promoted as "visually clean" by
the company housekeeping policy. Importantly, the investigators found
that the beryllium contamination could be transferred from body region
to body region (e.g., hand to face, neck to face) demonstrating the
importance of dermal protection measures since sensitization can occur
via dermal exposure as well as respiratory exposure. The investigators
demonstrated multiple pathways of exposure which could lead to
sensitization, increasing risk for developing CBD (Day et al., 2007,
Document ID 1548).
The same group of investigators extended their work on
investigating multiple exposure pathways contributing to sensitization
and CBD (Armstrong et al., 2014, Document ID 0502). The investigators
evaluated four different beryllium manufacturing and processing
facilities to assess the contribution of various exposure pathways on
worker exposure. Airborne, work surface and cotton glove beryllium
concentrations were evaluated. The investigators found strong
correlations between air and surface concentrations; glove and surface
concentrations; and air and glove concentrations at this facility. This
work supports findings from Day et al. (2007) (Document ID 1548)
demonstrating the importance of airborne beryllium concentrations to
surface contamination and dermal exposure even at exposures below the
preceding OSHA PEL (Armstrong et al., 2014, Document ID 0502).
OSHA received comments regarding the potential for dermal
penetration of poorly soluble particles. Materion contended there is no
supporting evidence to suggest that insoluble or poorly soluble
particles penetrate skin and stated:
. . . we were aware that, a hypothesis has been put forth which
suggests that being sensitized to beryllium either through a skin
wound or via penetration of small beryllium particles through intact
skin could result in sensitization to beryllium which upon receiving
a subsequent inhalation dose of airborne beryllium could result in
CBD. However, there are no studies that skin absorption of insoluble
beryllium results in a systemic effect. The study by Curtis, the
only human study looking for evidence of a beryllium sensitization
reaction occurring through intact human skin, found no sensitization
reaction using insoluble forms of beryllium. (Document ID 1661, p.
12).
OSHA disagrees with the assertion that no studies are available
indicating skin absorption of poorly soluble (insoluble) beryllium. In
addition to the study cited by Materion (Curtis, 1951, Document ID
1273), OSHA reviewed numerous studies on the effects of beryllium
solubility and dermal penetration (see section V. B. 2) including the
Tinkle et al. (2003) (Document ID 1483) study which demonstrated the
potential for poorly soluble beryllium particles to penetration skin
using an ex vivo human skin model. While OSHA believes that these
studies demonstrate poorly soluble beryllium can in fact penetrate
intact skin, penetration through intact skin is not the only means for
a person to become sensitized through skin contact with poorly soluble
beryllium. During the informal hearing proceedings, NIOSH was asked
about the role of poorly soluble beryllium in sensitizing workers to
beryllium. Aleks Stefaniak, Ph.D., NIOSH, stated that "intact skin
naturally has a barrier that prevents moisture from seeping out of the
body and things from getting into the body. Very few people actually
have fully intact skin, especially in an industrial environment. So the
skin barrier is often compromised, which would make penetration of
particles much easier." (Document ID 1755, Tr. 36).
As summarized above, poorly soluble beryllium particles have been
shown to solubilize in biological fluids (e.g., sweat) releasing
beryllium ions and making them available for absorption through intact
skin (Sutton et al., 2003, Document ID 1393; Stefaniak et al. 2014
(0517); Duling et al., 2012 (0539)). Epidemiological studies evaluating
the effectiveness of PPE in facilities working with beryllium (with
special emphasis on skin protection) have demonstrated a reduced rate
of beryllium sensitization after implementation of this type of control
(Day et al., 2007, Document ID 1548; Armstrong et al., 2014 (0502)).
Dr. Stefaniak confirmed these findings:
[T]he particles can actually dissolve when they're in contact
with liquids on the skin, like sweat. So we've actually done a
series of studies, using a simulant of sweat, but it had
characteristics that very closely matched human sweat. We see in
those studies that, in fact, beryllium particles, beryllium oxide,
beryllium metal, beryllium alloys, all these sort of what we call
insoluble forms actually do in fact dissolve very readily in analog
of human sweat. And once beryllium is in an ionic form on the skin,
it's actually very easy for it to cross the skin barrier. And that's
been shown many, many times in studies that beryllium ions can cross
the skin and induce sensitization. (Document ID 1755, Tr. 36-37).
Based on information from various studies demonstrating that poorly
soluble particles have the potential to penetrate skin, that skin as a
barrier is rarely intact (especially in industrial settings), and that
beryllium particles can readily dissolve in sweat and other biological
fluids, OSHA finds that dermal exposure to poorly soluble beryllium can
cause sensitization (Rossman, et al., 1991, Document ID 1332; Deubner
et al., 2001 (1542); Tinkle et al., 2003 (1483); Sutton et al., 2003
(1393); Stefaniak et al., 2011 (0537) and 2014 (0517); Duling et al.,
2012 (0539); Document ID 1755, Tr. 36-37).
3. Oral and Gastrointestinal Exposure
According to the WHO Report (2001), gastrointestinal absorption of
beryllium can occur by both the inhalation and oral routes of exposure
(Document ID 1282). In the case of inhalation, a portion of the inhaled
material is transported to the gastrointestinal tract by the
mucociliary escalator or by the swallowing of the poorly soluble
material deposited in the upper respiratory tract (Schlesinger, 1997,
Document ID 1290). Animal studies have shown oral administration of
beryllium compounds to result in very limited absorption and storage
(as reviewed by U.S. EPA, 1998, Document ID 0661). Oral studies
utilizing radio-labeled beryllium chloride in rats, mice, dogs, and
monkeys, found the majority of the beryllium was unabsorbed by the
gastrointestinal tract and was eliminated in the feces. In most
studies, less than 1 percent of the administered radioactivity was
absorbed into the bloodstream and subsequently excreted in the urine
(Crowley et al., 1949, Document ID 1551; Furchner et al., 1973 (1523);
LeFevre and Joel, 1986 (1464)). Research using soluble beryllium
sulfate has shown that as the compound passes into the intestine, which
has a higher pH than the stomach (approximate pH of 6 to 8 for the
intestine, pH of 1 or 2 for the stomach), the beryllium is precipitated
as the poorly soluble phosphate and is not absorbed (Reeves, 1965,
Document ID 1430; WHO, 2001 (1282)).
Further studies suggested that beryllium absorbed into the
bloodstream is primarily excreted via urine (Crowley et al., 1949,
Document ID 1551; Furchner et al., 1973 (1523); Scott et al., 1950
(1413); Stiefel et al., 1980 (1288)). Unabsorbed beryllium is primarily
excreted via the fecal route (Finch et al., 1990, Document ID 1318;
Hart et al., 1980 (1493)). Parenteral administration in a variety of
animal species demonstrated that beryllium was eliminated at much
higher percentages in the urine than in the feces (Crowley et al.,
1949, Document ID 1551; Furchner et al., 1973 (1523); Scott et al.,
1950 (1413)). A study using percutaneous administration of soluble
beryllium nitrate in rats demonstrated that more than 90 percent of the
beryllium in the bloodstream was eliminated via urine (WHO, 2001,
Document ID 1282). Greater than 99 percent of ingested beryllium
chloride was excreted in the feces (Mullen et al., 1972, Document ID
1442). A study of mice, rats, monkeys, and dogs given intravenously
dosed with beryllium chloride determined elimination half-times to be
between 890 to 1,770 days (2.4 to 4.8 years) (Furchner et al., 1973,
Document ID 1523). In a comparison study, baboons and rats were
instilled intratracheally with beryllium metal. Mean daily excretion
rates were calculated as 4.6 x 10-5 percent of the dose
administered in baboons and 3.1 x 10-5 percent in rats
(Andre et al., 1987, Document ID 0351).
In summary, animal studies evaluating the absorption, distribution
and excretion of beryllium compounds found that, in general, poorly
soluble beryllium compounds were not readily absorbed in the
gastrointestinal tract and was mostly excreted via feces (Hart et al.,
1980, Document ID 1493; Finch et al., 1990 (1318); Mullen et al., 1972
(1442)). Soluble beryllium compounds orally administered were partially
cleared via urine; however, some soluble forms are precipitated in the
gastrointestinal tract due to different pH values between the intestine
and the stomach (Reeves, 1965, Document ID 1430). Intravenous
administration of
poorly soluble beryllium compounds were distributed systemically
through the lymphatics and stored in the skeleton for potential later
release (Furchner et al., 1973, Document ID 1523). Therefore, while
intravenous administration can lead to uptake, OSHA does not consider
oral and gastrointestinal exposure to be a major route for the uptake
of beryllium because poorly soluble beryllium is not readily absorbed
in the gastrointestinal tract.
4. Metabolism
Beryllium and its compounds may not be metabolized or
biotransformed, but soluble beryllium salts may be converted to less
soluble forms in the lung (Reeves and Vorwald, 1967, Document ID 1309).
As stated earlier, solubility is an important factor for persistence of
beryllium in the lung. Poorly soluble phagocytized beryllium particles
can be dissolved into an ionic form by an acidic cellular environment
and by myeloperoxidases or macrophage phagolysomal fluids (Leonard and
Lauwerys, 1987, Document ID 1293; Lansdown, 1995 (1469); WHO, 2001
(1282); Stefaniak et al., 2006 (1398)). The positive charge of the
beryllium ion could potentially make it more biologically reactive
because it may allow the beryllium to bind to a peptide or protein and
be presented to the T cell receptor or antigen-presenting cell
(Fontenot, 2000, Document ID 1531).
5. Conclusion For Particle Characterization and Kinetics and Metabolism
of Beryllium
The forms and concentrations of beryllium across the workplace vary
substantially based upon location, process, production and work task.
Many factors may influence the potency of beryllium including
concentration, composition, structure, size, solubility and surface
area of the particle.
Studies have demonstrated that beryllium sensitization can occur
via the skin or inhalation from soluble or poorly soluble beryllium
particles. Beryllium must be presented to a cell in a soluble form for
activation of the immune system (NAS, 2008, Document ID 1355), and this
will be discussed in more detail in the section to follow. Poorly
soluble beryllium can be solubilized via intracellular fluid, lung
fluid and sweat to release beryllium ions (Sutton et al., 2003,
Document ID 1393; Stefaniak et al., 2011(0537) and 2014(0517)). For
beryllium to persist in the lung it needs to be poorly soluble.
However, soluble beryllium has been shown to precipitate in the lung to
form poorly soluble beryllium (Reeves and Vorwald, 1967, Document ID
1309).
Some animal and epidemiological studies suggest that the form of
beryllium may affect the rate of development of BeS and CBD. Beryllium
in an inhalable form (either as soluble or poorly soluble particles or
mist) can deposit in the respiratory tract and interact with immune
cells located along the entire respiratory tract (Scheslinger, 1997,
Document ID 1290). Interaction and presentation of beryllium (either in
ionic or particulate form) is discussed further in Section V.D.1.
C. Acute Beryllium Diseases
Acute beryllium disease (ABD) is a relatively rapid onset
inflammatory reaction resulting from breathing high airborne
concentrations of beryllium. It was first reported in workers
extracting beryllium oxide (Van Ordstrand et al., 1943, Document ID
1383) and later reported by Eisenbud (1948) and Aub (1949) (as cited in
Document ID 1662, p. 2). Since the Atomic Energy Commission's adoption
of a maximum permissible peak occupational exposure limit of 25 μg/
m3\ for beryllium beginning in 1949, cases of ABD have been much
rarer. According to the World Health Organization (2001), ABD is
generally associated with exposure to beryllium levels at or above 100
μg/m3\ and may be fatal in 10 percent of cases (Document ID 1282).
However, cases of ABD have been reported with beryllium exposures below
100 µg/m3\ (Cummings et al., 2009, Document ID 1550). The
Cummings et al. (2009) study examined two cases of workers exposed to
soluble and poorly soluble beryllium below 100 µg/m3\ using data
obtained from company records. Cummings et al. (2009) also examined the
possibility that an immune-mediated mechanism may exist for ABD as well
as CBD and that ABD and CBD are on a pathological continuum since some
patients would later develop CBD after recovering from ABD (ACCP, 1965,
Document ID 1286; Hall, 1950 (1494); Cummings et al., 2009 (1550)).
ABD involves an inflammatory or immune-mediated reaction that may
include the entire respiratory tract, involving the nasal passages,
pharynx, bronchial airways and alveoli. Other tissues including skin
and conjunctivae may be affected as well. The clinical features of ABD
include a nonproductive cough, chest pain, cyanosis, shortness of
breath, low-grade fever and a sharp drop in functional parameters of
the lungs. Pathological features of ABD include edematous distension,
round cell infiltration of the septa, proteinaceous materials, and
desquamated alveolar cells in the lung. Monocytes, lymphocytes and
plasma cells within the alveoli are also characteristic of the acute
disease process (Freiman and Hardy, 1970, Document ID 1527).
Two types of acute beryllium disease have been characterized in the
literature: A rapid and severe course of acute fulminating pneumonitis
generally developing within 48 to 72 hours of a massive exposure, and a
second form that takes several days to develop from exposure to lower
concentrations of beryllium (still above the levels set by regulatory
and guidance agencies) (Hall, 1950, Document ID 1494; DeNardi et al.,
1953 (1545); Newman and Kreiss, 1992 (1440)). Evidence of a dose-
response relationship to the concentration of beryllium is limited
(Eisenbud et al., 1948, Document ID 0490; Stokinger, 1950 (1484);
Sterner and Eisenbud, 1951 (1396)). Recovery from either type of ABD is
generally complete after a period of several weeks or months (DeNardi
et al., 1953, Document ID 1545). However, deaths have been reported in
more severe cases (Freiman and Hardy, 1970, Document ID 1527).
According to the BCR, in the United States, approximately 17 percent of
ABD patients developed CBD (BCR, 2010). The majority of ABD cases
occurred between 1932 and 1970 (Eisenbud, 1982, Document ID 1254;
Middleton, 1998 (1445)). ABD is extremely rare in the workplace today
due to more stringent exposure controls implemented following
occupational and environmental standards set in 1970-1971 (ACGIH, 1971,
Document ID 0543; ANSI, 1970 (1303); OSHA, 1971, see 39 FR 23513; EPA,
1973 (38 FR 8820)).
Materion submitted post-hearing comments regarding ABD (Document ID
1662, p. 2; Attachment A, p. 1). Materion contended that only soluble
forms of beryllium have been demonstrated to produce ABD at exposures
above 100 µg/m3\ because cases of ABD were only found in workers
exposed to beryllium during beryllium extraction processes which always
contain soluble beryllium (Document ID 1662, pp. 2, 3). Citing
communications between Marc Kolanz (Materion) and Dr. Eisenbud,
Materion noted that when Mr. Kolanz asked Dr. Eisenbud if he ever
"observed an acute reaction to beryllium that did not involve the
beryllium extraction process and exposure to soluble salts of
beryllium," Dr. Eisenbud responded that "he did not know of a case
that was not either directly associated with
exposure to soluble compounds or where the work task or operation would
have been free from exposure to soluble beryllium compounds from
adjacent operations." (Document ID 1662, p. 3). OSHA acknowledges that
workers with ABD may have been exposed to a combination of soluble and
poorly soluble beryllium. This alone, however, cannot completely
exclude poorly soluble beryllium as a causative or contributing agent
of ABD. The WHO (2001) has concluded that both ABD and CBD results from
exposure to both soluble and insoluble forms of beryllium. In addition,
the European Commission has classified poorly soluble beryllium and
beryllium oxide as acute toxicity categories 2 and 3 (Document ID 1669,
p. 2).
Additional comments from Materion regarding ABD criticized the
study by Cummings et al. (2009), stating that it "incompletely
explained the source of the workers exposures, which resulted in the
use of a misleading statement that, `None of the measured air samples
exceeded 100 μg/m3\ and most were less than 10 μg/m3\.' "
(Document ID 1662, p. 3). Materion argues that the Cummings et al.
study is not valid because workers in that study "had been involved
with high exposures to soluble beryllium salts caused by upsets during
the chemical extraction of beryllium." (Document ID 1662, pp. 3-4). In
response, NIOSH written testimony explained that the measurements in
the study "were collected in areas most likely to be sources of high
beryllium exposures in processes, but were not personal breathing zone
measurements in the usual sense." (Document ID 1725, p. 3). "Cummings
et al. (2009) made every effort to overestimate (rather than
underestimate) exposure," including "select[ing] the highest time
weighted average (TWA) value from the work areas or activities
associated with a worker's job and tenure" and not adjusting for
"potential protective effects of respirators, which were reportedly
used for some tasks and during workplace events potentially associated
with uncontrolled higher exposures." Even so, "the available TWA data
did not exceed 100 μg/m3\ even on days with evacuations."
(Document ID 1725, p. 3). Furthermore, OSHA notes that, the discussion
in Cummings et al. (2009) stated, "we cannot rule out the possibility
of unusually elevated airborne concentrations of beryllium that went
unmeasured." (Document ID 1550, p. 5).
In response to Materion's contention that OSHA should eliminate the
section on ABD because this disease is no longer a concern today
(Document ID 1661, p. 2), OSHA notes that the discussion on ABD is
included for thoroughness in review of the health effects caused by
exposure to beryllium. As indicated above, the Agency acknowledges that
ABD is extremely rare, but not non-existent, in workplaces today due to
the more stringent exposure controls implemented since OSHA's inception
(OSHA, 1971, see 39 FR 23513).
D. Beryllium Sensitization and Chronic Beryllium Disease
This section provides an overview of the immunology and
pathogenesis of BeS and CBD, with particular attention to the role of
skin sensitization, particle size, beryllium compound solubility, and
genetic variability in individuals' susceptibility to beryllium
sensitization and CBD.
Chronic beryllium disease (CBD), formerly known as "berylliosis"
or "chronic berylliosis," is a granulomatous disorder primarily
affecting the lungs. CBD was first described in the literature by Hardy
and Tabershaw (1946) as a chronic granulomatous pneumonitis (Document
ID 1516). It was proposed as early as 1951 that CBD could be a chronic
disease resulting from sensitization to beryllium (Sterner and
Eisenbud, 1951, Document ID 1396; Curtis, 1959 (1273); Nishimura, 1966
(1435)). However, for a time, there remained some controversy as to
whether CBD was a delayed-onset hypersensitivity disease or a toxicant-
induced disease (NAS, 2008, Document ID 1355). Wide acceptance of CBD
as a hypersensitivity lung disease did not occur until bronchoscopy
studies and bronchoalveolar lavage (BAL) studies were performed
demonstrating that BAL cells from CBD patients responded to beryllium
challenge (Epstein et al., 1982, Document ID 0436; Rossman et al., 1988
(0476); Saltini et al., 1989 (1351)).
CBD shares many clinical and histopathological features with
pulmonary sarcoidosis, a granulomatous lung disease of unknown
etiology. These similarities include such debilitating effects as
airway obstruction, diminishment of physical capacity associated with
reduced lung function, possible depression associated with decreased
physical capacity, and decreased life expectancy. Without appropriate
information, CBD may be difficult to distinguish from sarcoidosis. It
is estimated that up to 6 percent of all patients diagnosed with
sarcoidosis may actually have CBD (Fireman et al., 2003, Document ID
1533; Rossman and Kreider, 2003 (1423)). Among patients diagnosed with
sarcoidosis in which beryllium exposure can be confirmed, as many as 40
percent may actually have CBD (Muller-Quernheim et al., 2005, Document
ID 1262; Cherry et al., 2015 (0463)).
Clinical signs and symptoms of CBD may include, but are not limited
to, a simple cough, shortness of breath or dypsnea, fever, weight loss
or anorexia, skin lesions, clubbing of fingers, cyanosis, night sweats,
cor pulmonale, tachycardia, edema, chest pain and arthralgia. Changes
or loss of pulmonary function also occur with CBD such as decrease in
vital capacity, reduced diffusing capacity, and restrictive breathing
patterns. The signs and symptoms of CBD constitute a continuum of
symptoms that are progressive in nature with no clear demarcation
between any stages in the disease (Pappas and Newman, 1993, Document ID
1433; Rossman, 1996 (1283); NAS, 2008 (1355)). These symptoms are
consistent with the CBD symptoms described during the public hearing by
Dr. Kristin Cummings of NIOSH and Dr. Lisa Maier of National Jewish
Health (Document ID 1755, Tr. 70-71; 1756, Tr. 105-107).
Besides these listed symptoms from CBD patients, there have been
reported cases of CBD that remained asymptomatic (Pappas and Newman,
1993, Document ID 1433; Muller-Querheim, 2005 (1262); NAS, 2008 (1355);
NIOSH, 2011 (0544)). Asymptomatic CBD refers to those patients that
have physiological changes upon clinical evaluation yet exhibit no
outward signs or symptoms (also referred to as subclinical CBD).
Unlike ABD, CBD can result from inhalation exposure to beryllium at
levels below the preceding OSHA PEL, can take months to years after
initial beryllium exposure before signs and symptoms of CBD occur
(Newman 1996, Document ID 1283, 2005 (1437) and 2007 (1335);
Henneberger, 2001 (1313); Seidler et al., 2012 (0457); Schuler et al.,
2012 (0473)), and may continue to progress following removal from
beryllium exposure (Newman, 2005, Document ID 1437; Sawyer et al., 2005
(1415); Seidler et al., 2012 (0457)). Patients with CBD can progress to
a chronic obstructive lung disorder resulting in loss of quality of
life and the potential for decreased life expectancy (Rossman, et al.,
1996, Document ID 1425; Newman et al., 2005 (1437)). The National
Academy of Sciences (NAS) report (2008) noted the general lack of
published studies on progression of CBD from an early asymptomatic
stage to functionally significant lung disease (NAS, 2008, Document ID
1355). The report emphasized that risk factors and
time course for clinical disease have not been fully delineated.
However, for people now under surveillance, clinical progression from
sensitization and early pathological lesions (i.e., granulomatous
inflammation) prior to onset of symptoms to symptomatic disease appears
to be slow, although more follow-up is needed (NAS, 2008, Document ID
1355). A study by Newman (1996) emphasized the need for prospective
studies to determine the natural history and time course from beryllium
sensitization and asymptomatic CBD to full-blown disease (Newman, 1996,
Document ID 1283). Drawing from his own clinical experience, Dr. Newman
was able to identify the sequence of events for those with symptomatic
disease as follows: Initial determination of beryllium sensitization;
gradual emergence of chronic inflammation of the lung; pathologic
alterations with measurable physiologic changes (e.g., pulmonary
function and gas exchange); progression to a more severe lung disease
(with extrapulmonary effects such as clubbing and cor pulmonale in some
cases); and finally death in some cases (reported between 5.8 to 38
percent) (NAS, 2008, Document ID 1355; Newman, 1996 (1283)).
In contrast to some occupationally related lung diseases, the early
detection of chronic beryllium disease may be useful since treatment of
this condition can lead not only to regression of the signs and
symptoms, but also may prevent further progression of the disease in
certain individuals (Marchand-Adam et al., 2008, Document ID 0370; NAS,
2008 (1355)). The management of CBD is based on the hypothesis that
suppression of the hypersensitivity reaction (i.e., granulomatous
process) will prevent the development of fibrosis. However, once
fibrosis has developed, therapy cannot reverse the damage.
A study by Pappas and Newman (1993) observed that patients with
known prior beryllium exposure and identified as confirmed positive for
beryllium sensitization through the beryllium lymphocyte proliferation
test (BeLPT) screening were evaluated for physiological changes in the
lung. Pappas and Newman categorized the patients as being either
"clinically identified," meaning they had known physiological
abnormalities (e.g., abnormal chest radiogram, respiratory symptoms) or
"surveillance-identified," meaning they had BeLPT positive results
with no reported symptoms, to differentiate state of disease
progression. Physiological changes were identified by three factors:
(1) Reduced tolerance to exercise; (2) abnormal pulmonary function test
during exercise; (3) abnormal arterial blood gases during exercise. Of
the patients identified as "surveillance identified," 52 percent had
abnormal exercise physiologies while 87 percent of the "clinically
identified" patients had abnormal physiologies (Pappas and Newman,
1993, Document ID 1433). During the public hearing, Dr. Newman noted
that:
. . . one of the sometimes overlooked points is that in that study .
. . the majority of people who were found to have early stage
disease already had physiologic impairment. So before the x-ray or
the CAT scan could find it the BeLPT had picked it up, we had made a
diagnosis of pathology in those people, and their lung function
tests--their measures of gas exchange, were already abnormal. Which
put them on our watch list for early and more frequent monitoring so
that we could observe their worsening and then jump in with
treatment at the earliest appropriate time. So there is advantage of
having that early diagnosis in terms of the appropriate tracking and
appropriate timing of treatment. (Document ID 1756, p. 112).
OSHA was unable to find any controlled studies to determine the
optimal treatment for CBD (see Rossman, 1996, Document ID 1425; NAS
2008 (1355); Sood, 2009 (0456)), and none were added to the record
during the public comment period. Management of CBD is generally
modeled after sarcoidosis treatment. Oral corticosteroid treatment can
be initiated in patients with evidence of disease (either by
bronchoscopy or other diagnostic measures before progression of disease
or after clinical signs of pulmonary deterioration occur). This
includes treatment with other anti-inflammatory agents (NAS, 2008.
Document ID 1355; Maier et al., 2012 (0461); Salvator et al., 2013
(0459)) as well. It should be noted, however, that treatment with
corticosteroids has side-effects of their own that need to be measured
against the possibility of progression of disease (Gibson et al., 1996,
Document ID 1521; Zaki et al., 1987 (1374)). Alternative treatments
such as azathioprine and infliximab, while successful at treating
symptoms of CBD, have been demonstrated to have side effects as well
(Pallavicino et al., 2013, Document ID 0630; Freeman, 2012 (0655)).
1. Development of Beryllium Sensitization
Sensitization to beryllium is an essential step for worker
development of CBD. Sensitization to beryllium can result from
inhalation exposure to beryllium (Newman et al., 2005, Document ID
1437; NAS, 2008 (1355)), as well as from skin exposure to beryllium
(Curtis, 1951, Document ID 1273; Newman et al., 1996 (1439); Tinkle et
al., 2003 (1483); Rossman, et al., 1991, (1332); Deubner et al., 2001
(1542); Tinkle et al., 2003 (1483); Sutton et al., 2003 (1393);
Stefaniak et al., 2011 (0537) and 2014 (0517); Duling et al., 2012
(0539); Document ID 1755, Tr. 36-37). Representative Robert C.
"Bobby" Scott, Ranking Member of Committee on Education and the
Workforce, the U.S. House of Representatives, provided comments to the
record stating that "studies have demonstrated that beryllium
sensitization, an indicator of immune response to beryllium, can occur
from both soluble and poorly soluble beryllium particles." (Document
ID 1672, p. 3).
Sensitization is currently detected using the BeLPT (a laboratory
blood test) described in section V.D.5. Although there may be no
clinical symptoms associated with beryllium sensitization, a sensitized
worker's immune system has been activated to react to beryllium
exposures such that subsequent exposure to beryllium can progress to
serious lung disease (Kreiss et al., 1996, Document ID 1477; Newman et
al., 1996 (1439); Kreiss et al., 1997 (1360); Kelleher et al., 2001
(1363); Rossman, 2001 (1424); Newman et al., 2005 (1437)). Since the
pathogenesis of CBD involves a beryllium-specific, cell-mediated immune
response, CBD cannot occur in the absence of sensitization (NAS, 2008,
Document ID 1355). The expert peer reviewers agreed that the scientific
evidence supported sensitization as a necessary condition and an early
endpoint in the development of CBD (ERG, 2010, Document ID 1270, pp.
19-21). Dr. John Balmes remarked that the "scientific evidence
reviewed in the [Health Effects] document supports consideration of
beryllium sensitization as an early endpoint and as a necessary
condition in the development of CBD." Dr. Patrick Breysee stated that
"there is strong scientific consensus that sensitization is a key
first step in the progression of CBD." Dr. Terry Gordon stated that
"[a]s discussed in the draft [Health Effects] document, beryllium
sensitization should be considered as an early endpoint in the
development of CBD." Finally, Dr. Milton Rossman agreed "that
sensitization is necessary for someone to develop CBD and should be
considered a condition/risk factor for the development of CBD."
Various factors, including genetic susceptibility, have been shown to
influence risk of developing sensitization and CBD (NAS 2008, Document
ID 1355) and will be discussed later in this section.
While various mechanisms or pathways may exist for beryllium
sensitization, the most plausible mechanisms supported by the best
available and most current science are discussed below. Sensitization
occurs via the formation of a beryllium-protein complex (an antigen)
that causes an immunological response. In some instances, onset of
sensitization has been observed in individuals exposed to beryllium for
only a few months (Kelleher et al., 2001, Document ID 1363; Henneberger
et al., 2001 (1313)). This suggests the possibility that relatively
brief, short-term beryllium exposures may be sufficient to trigger the
immune hypersensitivity reaction. Several studies (Newman et al., 2001,
Document ID 1354; Henneberger et al., 2001 (1313); Rossman, 2001
(1424); Schuler et al., 2005 (0919); Donovan et al., 2007 (0491),
Schuler et al., 2012 (0473)) have detected a higher prevalence of
sensitization among workers with less than one year of employment
compared to some cross-sectional studies which, due to lack of
information regarding initial exposure, cannot determine time of
sensitization (Kreiss et al., 1996, Document ID 1477; Kreiss et al.,
1997 (1360)). While only very limited evidence has described humoral
changes in certain patients with CBD (Cianciara et al., 1980, Document
ID 1553), clear evidence exists for an immune cell-mediated response,
specifically the T-cell (NAS, 2008, Document ID 1355). Figure 2
delineates the major steps required for progression from beryllium
contact to sensitization to CBD.
[GRAPHIC] [TIFF OMITTED] TR09JA17.001
Beryllium presentation to the immune system is believed to occur
either by direct presentation or by antigen processing. It has been
postulated that beryllium must be presented to the immune system in an
ionic form for cell-mediated immune activation to occur (Kreiss et al.,
2007, Document ID 1475). Some soluble forms of beryllium are readily
presented, since the soluble beryllium form disassociates into its
ionic components. However, for poorly soluble forms, dissolution may
need to occur. A study by Harmsen et al. (1986) suggested that a
sufficient rate of dissolution of small amounts of poorly soluble
beryllium compounds might occur in the lungs to allow persistent
low-level beryllium presentation to the immune system (Document ID
1257). Stefaniak et al. (2006 and 2012) reported that poorly soluble
beryllium particles phagocytized by macrophages were dissolved in
phagolysomal fluid (Stefaniak et al., 2006, Document ID 1398; Stefaniak
et al., 2012 (0469)) and that the dissolution rate stimulated by
phagolysomal fluid was different for various forms of beryllium
(Stefaniak et al., 2006, Document ID 1398; Duling et al., 2012 (0539)).
Several studies have demonstrated that macrophage uptake of beryllium
can induce aberrant apoptotic processes leading to the continued
release of beryllium ions which will continually stimulate T-cell
activation (Sawyer et al., 2000, Document ID 1417; Sawyer et al., 2004
(1416); Kittle et al., 2002 (0485)). Antigen processing can be mediated
by antigen-presenting cells (APC). These may include macrophages,
dendritic cells, or other antigen-presenting cells, although this has
not been well defined in most studies (NAS, 2008, Document ID 1355).
Because of their strong positive charge, beryllium ions have the
ability to haptenate and alter the structure of peptides occupying the
antigen-binding cleft of major histocompatibility complex (MHC) class
II on antigen-presenting cells (APC). The MHC class II antigen-binding
molecule for beryllium is the human leukocyte antigen (HLA) with
specific alleles (e.g., HLA-DP, HLA-DR, HLA-DQ) associated with the
progression to CBD (NAS, 2008, Document ID 1355; Yucesoy and Johnson,
2011 (0464); Petukh et al., 2014 (0397)). Several studies have also
demonstrated that the electrostatic charge of HLA may be a factor in
binding beryllium (Snyder et al., 2003, Document ID 0524; Bill et al.,
2005 (0499); Dai et al., 2010 (0494)). The strong positive ionic charge
of the beryllium ion would have a strong attraction for the negatively
charged patches of certain HLA alleles (Snyder et al., 2008, Document
ID 0471; Dai et al., 2010 (0494); Petukh et al., 2014 (0397)).
Alternatively, beryllium oxide has been demonstrated to bind to the MHC
class II receptor in a neutral pH. The six carboxylates in the amino
acid sequence of the binding pocket provide a stable bond with the Be-
O-Be molecule when the pH of the substrate is neutral (Keizer et al.,
2005, Document ID 0455). The direct binding of BeO may eliminate the
biological requirement for antigen processing or dissolution of
beryllium oxide to activate an immune response.
Once the beryllium-MHC-APC complex is established, the complex
binds to a T-cell receptor (TCR) on a na[iuml]ve T-cell which
stimulates the proliferation and accumulation of beryllium-specific
CD4+ (cluster of differentiation 4\+\) T-cells (Saltini et al., 1989,
Document ID 1351 and 1990 (1420); Martin et al., 2011 (0483)) as
depicted in Figure 3. Fontenot et al. (1999) demonstrated that
diversely different variants of TCR were expressed by CD4+ T-cells in
peripheral blood cells of CBD patients. However, the CD4+ T-cells
from the lung were more homologous in expression of TCR variants in CBD
patients, suggesting clonal expansion of a subset of T-cells in the
lung (Fontenot et al., 1999, Document ID 0489). This may also indicate
a pathogenic potential for subsets of T-cell clones expressing this
homologous TCR (NAS, 2008, Document ID 1355). Fontenot et al. (2006)
(Document ID 0487) reported beryllium self-presentation by HLA-DP
expressing BAL CD4+ T-cells. According the NAS report, BAL T-cell
self-presentation in the lung granuloma may result in cell death,
leading to oligoclonality (only a few clones) of the T-cell population
characteristic of CBD (NAS, 2008, Document ID 1355).
[GRAPHIC] [TIFF OMITTED] TR09JA17.002
As CD4+ T-cells proliferate, clonal expansion of various subsets
of the CD4+ beryllium specific T-cells occurs (Figure 3). In the
peripheral blood, the beryllium-specific CD4+ T cells require co-
stimulation with a co-stimulant CD28 (cluster of differentiation 28).
During the proliferation and differentiation process CD4+ T-cells
secrete pro-inflammatory cytokines that may influence this process
(Sawyer et al., 2004, Document ID 1416; Kimber et al., 2011 (0534)).
In summary, OSHA concludes that sensitization is a necessary and
early functional change in the immune system that leads to the
development of CBD.
2. Development of CBD
The continued presence of residual beryllium in the lung leads to a
T-cell maturation process. A large portion of beryllium-specific CD4+
T cells were shown to cease expression of CD28 mRNA and protein,
indicating these cells no longer required co-stimulation with the CD28
ligand (Fontenot et al., 2003, Document ID 1529). This change in
phenotype correlated with lung inflammation (Fontenot et al., 2003,
Document ID 1529). While these CD4+ independent cells continued to
secrete cytokines necessary for additional recruitment of inflammatory
and immunological cells, they were less proliferative and less
susceptible to cell death compared to the CD28 dependent cells
(Fontenot et al., 2005, Document ID 1528; Mack et al., 2008 (1460)).
These beryllium-specific CD4+ independent cells are considered to be
mature memory effector cells (Ndejembi et al., 2006, Document ID 0479;
Bian et al., 2005 (0500)). Repeat exposure to beryllium in the lung
resulting in a mature population of T cell development independent of
co-stimulation by CD28 and development of a population of T effector
memory cells (Tem cells) may be one of the mechanisms that
lead to the more severe reactions observed specifically in the lung
(Fontenot et al., 2005, Document ID 1528).
CD4+ T cells created in the sensitization process recognize the
beryllium antigen, and respond by proliferating and secreting cytokines
and inflammatory mediators, including IL-2, IFN-[gamma], and TNF-
α (Tinkle et al., 1997, Document ID 1387; Tinkle et al., 1997
(1388); Fontenot et al., 2002 (1530)) and MIP-1α and GRO-1 (Hong-
Geller, 2006, Document ID 1511). This also results in the accumulation
of various types of inflammatory cells including mononuclear cells
(mostly CD4+ T cells) in the BAL fluid (Saltini et al., 1989,
Document ID 1351, 1990 (1420)).
The development of granulomatous inflammation in the lung of CBD
patients has been associated with the accumulation of beryllium
responsive CD4+ Tem cells in BAL fluid (NAS, 2008,
Document ID 1355). The subsequent release of pro-inflammatory
cytokines, chemokines and reactive oxygen species by these cells may
lead to migration of additional inflammatory/immune cells and the
development of a microenvironment that contributes to the development
of CBD (Sawyer et al., 2005, Document ID 1415; Tinkle et al., 1996
(0468); Hong-Geller et al., 2006 (1511); NAS, 2008 (1355)).
The cascade of events described above results in the formation of a
noncaseating granulomatous lesion. Release of cytokines by the
accumulating T cells leads to the formation of granulomatous lesions
that are characterized by an outer ring of histiocytes surrounding non-
necrotic tissue with embedded multi-nucleated giant cells (Saltini et
al., 1989, Document ID 1351, 1990 (1420)).
Over time, the granulomas spread and can lead to lung fibrosis and
abnormal
pulmonary function, with symptoms including a persistent dry cough and
shortness of breath (Saber and Dweik, 2000, Document ID 1421). Fatigue,
night sweats, chest and joint pain, clubbing of fingers (due to
impaired oxygen exchange), loss of appetite or unexplained weight loss,
and cor pulmonale have been experienced in certain patients as the
disease progresses (Conradi et al., 1971, Document ID 1319; ACCP, 1965
(1286); Kriebel et al., 1988, Document ID 1292; Kriebel et al., 1988
(1473)). While CBD primarily affects the lungs, it can also involve
other organs such as the liver, skin, spleen, and kidneys (ATSDR, 2002,
Document ID 1371).
As previously mentioned, the uptake of beryllium may lead to an
aberrant apoptotic process with rerelease of beryllium ions and
continual stimulation of beryllium-responsive CD4+ cells in the lung
(Sawyer et al., 2000, Document ID 1417; Kittle et al., 2002 (0485);
Sawyer et al., 2004 (1416)). Several research studies suggest apoptosis
may be one mechanism that enhances inflammatory cell recruitment,
cytokine production and inflammation, thus creating a scenario for
progressive granulomatous inflammation (Palmer et al., 2008, Document
ID 0478; Rana, 2008 (0477)). Macrophages and neutrophils can
phagocytize beryllium particles in an attempt to remove the beryllium
from the lung (Ding, et al., 2009, Document ID 0492)). Multiple studies
(Sawyer et al., 2004, Document ID 1416; Kittle et al., 2002 (0485))
using BAL cells (mostly macrophages and neutrophils) from patients with
CBD found that in vitro stimulation with beryllium sulfate induced the
production of TNF-α (one of many cytokines produced in response
to beryllium), and that production of TNF-α might induce
apoptosis in CBD and sarcoidosis patients (Bost et al., 1994, Document
ID 1299; Dai et al., 1999 (0495)). The stimulation of CBD-derived
macrophages by beryllium sulfate resulted in cells becoming apoptotic,
as measured by propidium iodide. These results were confirmed in a
mouse macrophage cell-line (p388D1) (Sawyer et al., 2000, Document ID
1417). However, other factors, such as genetic factors and duration or
level of exposure leading to a continued presence of beryllium in the
lung, may influence the development of CBD and are outlined in the
following sections V.D.3 and V.D.4.
In summary, the persistent presence of beryllium in the lung of a
sensitized individual creates a progressive inflammatory response that
can culminate in the granulomatous lung disease, CBD.
3. Genetic and Other Susceptibility Factors
Evidence from a variety of sources indicates genetic susceptibility
may play an important role in the development of CBD in certain
individuals, especially at levels low enough not to invoke a response
in other individuals. Early occupational studies proposed that CBD was
an immune reaction based on the high susceptibility of some individuals
to become sensitized and progress to CBD and the lack of CBD in others
who were exposed to levels several orders of magnitude higher (Sterner
and Eisenbud, 1951, Document ID 1396). Recent studies have confirmed
genetic susceptibility to CBD involves either, HLA variants, T-cell
receptor clonality, tumor necrosis factor (TNF-α) polymorphisms
and/or transforming growth factor-beta (TGF-β) polymorphisms
(Fontenot et al., 2000, Document ID 1531; Amicosante et al., 2005
(1564); Tinkle et al., 1996 (0468); Gaede et al., 2005 (0486); Van Dyke
et al., 2011 (1696); Silveira et al., 2012 (0472)).
Potential sources of variation associated with genetic
susceptibility have been investigated. Single Nucleotide Polymorphisms
(SNPs) have been studied with regard to genetic variations associated
with increased risk of developing CBD. SNPs are the most abundant type
of human genetic variation. Polymorphisms in MHC class II and pro-
inflammatory genes have been shown to contribute to variations in
immune responses contributing to the susceptibility and resistance in
many diseases including auto-immunity, beryllium sensitization, and CBD
(McClesky et al., 2009, as cited in Document ID 1808, p. 3). Specific
SNPs have been evaluated as a factor in the Glu69 variant from the HLA-
DPB1 locus (Richeldi et al., 1993, Document ID 1353; Cai et al., 2000
(0445); Saltini et al., 2001 (0448); Silviera et al., 2012 (0472); Dai
et al., 2013 (0493)). Other SNPs lacking the Glu69 variant, such as
HLA-DRPheβ47, have also been evaluated for an association with CBD
(Amicosante et al., 2005, Document ID 1564).
HLA-DPB1 (one of 2 subtypes of HLA-DP) with a glutamic acid at
amino position 69 (Glu69) has been shown to confer increased risk of
beryllium sensitization and CBD (Richeldi et al., 1993, Document ID
1353; Saltini et al., 2001 (0448); Amicosante et al., 2005 (1564); Van
Dyke et al., 2011 (1696); Silveira et al., 2012 (0472)). In vitro human
research has identified genes coding for specific protein molecules on
the surface of the immune cells of sensitized individuals from a cohort
of beryllium workers (McCanlies et al., 2004, Document ID 1449). The
research identified the HLA-DPB1 (Glu69) allele that place carriers at
greater risk of becoming sensitized to beryllium and developing CBD
than those not carrying this allele (McCanlies et al., 2004, Document
ID 1449). Fontenot et al. (2000) demonstrated that beryllium
presentation by certain alleles of the class II human leukocyte
antigen-DP (HLA-DP 3) to CD4+ T cells is the mechanism underlying
the development of CBD (Document ID 1531). Richeldi et al. (1993)
reported a strong association between the MHC class II allele HLA-DPB 1
and the development of CBD in beryllium-exposed workers from a Tucson,
AZ facility (Document ID 1353). This marker was found in 32 of the 33
workers who developed CBD, but in only 14 of 44 similarly exposed
workers without CBD. The more common alleles of the HLA-DPB 1
containing a variant of Glu69 are negatively charged at this site and
could directly interact with the positively charged beryllium ion.
Additional studies by Amicosante et al. (2005) (Document ID 1564) using
blood lymphocytes derived from beryllium-exposed workers found a high
frequency of this gene in those sensitized to beryllium. In a study of
82 CBD patients (beryllium-exposed workers), Stubbs et al. (1996)
(Document ID 1394) also found a relationship between the HLA-DP 1
allele and beryllium sensitization. The glutamate-69 allele was present
in 86 percent of sensitized subjects, but in only 48 percent of
beryllium-exposed, non-sensitized subjects. Some variants of the HLA-
DPB1 allele convey higher risk of sensitization and CBD than others.
For example, HLA-DPB1*0201 yielded an approximately 3-fold increase in
disease outcome relative to controls; HLA-DPB1*1901 yielded an
approximately 5-fold increase, and HLA-DPB1*1701 yielded an
approximately 10-fold increase (Weston et al., 2005, Document ID 1345;
Snyder et al., 2008 (0471)). Specifically, Snyder et al. (2008) found
that variants of the Glu69 allele with the greatest negative charge may
confer greater risk for developing CBD (Document ID 0471). The study by
Weston et al. (2005) assigned odds ratios for specific alleles on the
basis of previous studies discussed above (Document ID 1345). The
researchers found a strong
correlation (88 percent) between the reported risk of CBD and the
predicted surface electrostatic potential and charge of the isotypes of
the genes. They were able to conclude that the alleles associated with
the most negatively charged proteins carry the greatest risk of
developing beryllium sensitization and CBD (Weston et al., 2005,
Document ID 1345). This confirms the importance of beryllium charge as
a key factor in its ability to induce an immune response.
---------------------------------------------------------------------------
3 HLA-DP and HLA DPB1 alleles have been associated with
genetic susceptibility for developing CBD. HLA-DP has 2 subtypes,
HLA-DPA and HLA-DPB. HLA-DBP1 is involved with the Glu69 allele most
associated with genetic susceptibility.
---------------------------------------------------------------------------
In contrast, the HLA-DRB1 allele, which lacks Glu69, has also been
shown to increase the risk of developing sensitization and CBD
(Amicosante et al., 2005, Document ID 1564; Maier et al., 2003 (0484)).
Bill et al. (2005) found that HLA-DR has a glutamic acid at position 71
of the β chain, functionally equivalent to the Glu69 of HLA-DP
(Bill et al., 2005, Document ID 0499). Associations with BeS and CBD
have also been reported with the HLA-DQ markers (Amicosante et al.,
2005, Document ID 1564; Maier et al., 2003 (0484)). Stubbs et al. also
found a biased distribution of the MHC class II HLA-DR gene between
sensitized and non-sensitized subjects. Neither of these markers was
completely specific for CBD, as each study found beryllium
sensitization or CBD among individuals without the genetic risk factor.
While there remains uncertainty as to which of the MHC class II genes
interact directly with the beryllium ion, antibody inhibition data
suggest that the HLA-DR gene product may be involved in the
presentation of beryllium to T lymphocytes (Amicosante et al., 2002,
Document ID 1370). In addition, antibody blocking experiments revealed
that anti-HLA-DP strongly reduced proliferation responses and cytokine
secretion by BAL CD4 T cells (Chou et al., 2005, Document ID 0497). In
the study by Chou (2005), anti-HLA-DR ligand antibodies mainly affected
beryllium-induced proliferation responses with little impact on
cytokines other than IL-2, thus implying that non-proliferating BAL CD4
T cells may still contribute to inflammation leading to the progression
of CBD (Chou et al., 2005, Document ID 0497).
TNF alpha (TNF-α) polymorphisms and TGF beta (TGF-β)
polymorphisms have also been shown to confer a genetic susceptibility
for developing CBD in certain individuals. TNF-α is a pro-
inflammatory cytokine that may be associated with a more progressive
form of CBD (NAS, 2008). Beryllium exposure has been shown to
upregulate transcription factors AP-1 and NF-[kappa]B (Sawyer et al.,
2007, as cited in Document ID 1355) inducing an inflammatory response
by stimulating production of pro-inflammatory cytokines such as TNF-
α by inflammatory cells. Polymorphisms in the 308 position of the
TNF-α gene have been demonstrated to increase production of the
cytokine and increase severity of disease (Maier et al., 2001, Document
ID 1456; Saltini et al., 2001 (0448); Dotti et al., 2004 (1540)). While
a study by McCanlies et al. (2007) (Document ID 0482) of 886 beryllium
workers (including 64 sensitized for beryllium and 92 with CBD) found
no relationship between TNF-α polymorphism and sensitization or
CBD, the National Academies of Sciences noted that "discrepancies
between past studies showing associations and the more recent studies
may be due to misclassification, exposure differences, linkage
disequilibrium between HLA-DRB1 and TNF-α genes, or statistical
power." (NAS, 2008, Document ID 1355).
Other genetic variations have been shown to be associated with
increased risk of beryllium sensitization and CBD (NAS, 2008, Document
ID 1355). These include TGF-β (Gaede et al., 2005, Document ID
0486), angiotensin-1 converting enzyme (ACE) (Newman et al., 1992,
Document ID 1440; Maier et al., 1999 (1458)) and an enzyme involved in
glutathione synthesis (glutamate cysteine ligase) (Bekris et al., 2006,
as cited in Document ID 1355). McCanlies et al. (2010) evaluated the
association between polymorphisms in a select group of interleukin
genes (IL-1A; IL-1B, IL-1RN, IL-2, IL-9, IL-9R) due to their role in
immune and inflammatory processes (Document ID 0481). The study
evaluated SNPs in three groups of workers from large beryllium
manufacturing facilities in OH and AZ. The investigators found a
significant association between variants IL-1A-1142, IL-1A-3769 and IL-
1A-4697 and CBD but not between those variants and beryllium
sensitization.
In addition to the genetic factors which may contribute to the
susceptibility and severity of disease, other factors such as smoking
and sex may play a role in the development of CBD (NAS, 2008, Document
ID 1355). A recent longitudinal cohort study by Mroz et al. (2009) of
229 individuals identified with beryllium sensitization or CBD through
workplace medical surveillance found that the prevalence of CBD among
ever smokers was significantly lower than among never smokers (38.1
percent versus 49.4 percent, p = 0.025). BeS subjects that never smoked
were found to be more likely to develop CBD over the course of the
study compared to current smokers (12.6 percent versus 6.4 percent, p =
0.10). The authors suggested smoking may confer a protective effect
against development of lung granulomas as has been demonstrated with
hypersensitivity pneumonitis (Mroz et al., 2009, Document ID 1356).
4. Beryllium Sensitization and CBD in the Workforce
Sensitization to beryllium is currently detected in the workforce
with the beryllium lymphocyte proliferation test (BeLPT), a laboratory
blood test developed in the 1980s, also referred to as the LTT
(Lymphocyte Transformation Test) or BeLTT (Beryllium Lymphocyte
Transformation Test). In this test, lymphocytes obtained from either
bronchoalveolar lavage fluid (the BAL BeLPT) or from peripheral blood
(the blood BeLPT) are cultured in vitro and exposed to beryllium
sulfate to stimulate lymphocyte proliferation. The observation of
beryllium-specific proliferation indicates beryllium sensitization.
Hereafter, "BeLPT" generally refers to the blood BeLPT, which is
typically used in screening for beryllium sensitization. This test is
described in more detail in subsection D.5.b.
CBD can be detected at an asymptomatic stage by a number of
techniques including bronchoalveolar lavage and biopsy (Cordeiro et
al., 2007, Document ID 1552; Maier, 2001 (1456)). Bronchoalveolar
lavage is a method of "washing" the lungs with fluid inserted via a
flexible fiberoptic instrument known as a bronchoscope, removing the
fluid and analyzing the content for the inclusion of immune cells
reactive to beryllium exposure, as described earlier in this section.
Fiberoptic bronchoscopy can be used to detect granulomatous lung
inflammation prior to the onset of CBD symptoms as well, and has been
used in combination with the BeLPT to diagnose pre-symptomatic CBD in a
number of recent screening studies of beryllium-exposed workers, which
are discussed in the following section detailing diagnostic procedures.
Of workers who were found to be sensitized and underwent clinical
evaluation, 31 to 49 percent of them were diagnosed with CBD (Kreiss et
al., 1993, Document ID 1479; Newman et al., 1996 (1283), 2005 (1437),
2007 (1335); Mroz, 2009 (1356)), although some estimate that with
increased surveillance that percentage could be much higher (Newman,
2005, Document ID 1437; Mroz, 2009 (1356)). It has been estimated from
ongoing surveillance studies of sensitized individuals with an average
follow-up time of 4.5 years that
31 percent of beryllium-sensitized employees were estimated to progress
to CBD (Newman et al., 2005, Document ID 1437). The study by Newman et
al. (2005) was the first longitudinal study to assess the progression
from beryllium sensitization to CBD in individuals undergoing clinical
evaluation at National Jewish Medical and Research Center from 1988
through 1998. Approximately 50 percent of sensitized individuals (as
identified by BeLPT) had CBD at their initial clinical evaluation. The
remaining 50 percent, or 76 individuals, without evidence of CBD were
monitored at approximately two year intervals for indication of disease
progression by pulmonary function testing, chest radiography (with
International Labour Organization B reading), fiberoptic bronchoscopy
with bronchoalveolar lavage, and transbronchial lung biopsy. Fifty-five
of the 76 individuals were monitored with a range of two to five
clinical evaluations each. The Newman et al. (2005) study found that
CBD developed in 31 percent of individuals (17 of the 55) in a period
ranging from 1.0 to 9.5 years (average 3.8 years). After an average of
4.8 years (range 1.7 to 11.6 years) the remaining individuals showed no
signs of progression to CBD. A study of nuclear weapons facility
employees enrolled in an ongoing medical surveillance program found
that the sensitization rate in exposed workers increased rapidly over
the first 10 years of beryllium exposure and then more gradually in
succeeding years. On the other hand, the rate of CBD pathology
increased slowly over the first 15 years of exposure and then climbed
more steeply following 15 to 30 years of beryllium exposure (Stange et
al., 2001, Document ID 1403). The findings from these longitudinal
studies of sensitized workers provide evidence of CBD progression over
time from asymptomatic to symptomatic disease. One limitation for all
these studies is lack of long-term follow-up. Newman suggested that it
may be necessary to continue to monitor these workers in order to
determine whether all sensitized workers will develop CBD (Newman et
al., 2005, Document ID 1437).
CBD has a clinical spectrum ranging from evidence of beryllium
sensitization and granulomas in the lung with little symptomatology to
loss of lung function and end stage disease, which may result in the
need for lung transplantation and decreased life expectancy.
Unfortunately, there are very few published clinical studies describing
the full range and progression of CBD from the beginning to the end
stages and very few of the risk factors for progression of disease have
been delineated (NAS, 2008, Document ID 1355). OSHA requested
additional information in the NPRM, but no additional studies were
added during the public comment period. Clinical management of CBD is
modeled after sarcoidosis where oral corticosteroid treatment is
initiated in patients who have evidence of progressive lung disease,
although progressive lung disease has not been well defined (NAS, 2008,
Document ID 1355). In advanced cases of CBD, corticosteroids are the
standard treatment (NAS, 2008, Document ID 1355). No comprehensive
studies have been published measuring the overall effect of removal of
workers from beryllium exposure on sensitization and CBD (NAS, 2008,
Document ID 1355) although this has been suggested as part of an
overall treatment regime for CBD (Mapel et al., 2002, as cited in
Document ID 1850; Sood et al., 2004 (1331); Sood, 2009 (0456); Maier et
al., 2012 (0461)). Expert testimony from Dr. Lee Newman and Dr. Lisa
Maier agreed that while no studies exist on the efficacy of removal
from beryllium exposure, it is medically prudent to reduce beryllium
exposure once someone is sensitized (Document ID 1756, Tr. 142). Sood
et al. reported that cessation of exposure can sometimes have
beneficial effects on lung function (Sood et al., 2004, Document ID
1331). However, this was based on anecdotal evidence from six patients
with CBD, while this indicates a benefit of removal of patients from
exposure, more research is needed to better determine the relationship
between exposure duration and disease progression.
Materion commented that sensitization should be defined as a test
result indicating an immunological sensitivity to beryllium without
identifiable adverse health effects or other signs of illness or
disability. It went on to say that, for these reasons, sensitization is
not on a pathological continuum with CBD (Document ID 1661, pp. 4-7).
Other commenters disagreed. NIOSH addressed whether sensitization
should be considered an adverse health effect and said the following in
their written hearing testimony:
Some have questioned whether BeS should be considered an adverse
health effect. NIOSH views it as such, since it is a biological
change in people exposed to beryllium that is associated with
increased risk for developing CBD. BeS refers to the immune system's
ability to recognize and react to beryllium. BeS is an antigen-
specific cell mediated immunity to beryllium, in which CD4+ T cells
recognize a complex composed of beryllium ion, self-peptide, and
major histocompatibility complex (MHC) Class II molecule on an
antigen-presenting cell [Falta et al. (2013); Fontenot et al.
(2016)]. BeS necessarily precedes CBD. Pathogenesis depends on the
immune system's recognition of and reaction to beryllium in the
lung, resulting in granulomatous lung disease. BeS can be detected
with tests that assess the immune response, such as the beryllium
lymphocyte proliferation test (BeLPT), which measures T cell
activity in the presence of beryllium salts [Balmes et al. (2014)].
Furthermore, after the presence of BeS has been confirmed, periodic
medical evaluation at 1-3 year intervals thereafter is required to
assess whether BeS has progressed to CBD [Balmes et al. (2014)].
Thus, BeS is not just a test result, but an adverse health effect
that poses risk of the irreversible lung disease CBD. (Document ID
1725, p. 2)
The American College of Occupational and Environmental Medicine
(ACOEM) also commented that the term pathological "continuum" should
only refer to signs and symptoms associated with CBD because some
sensitized workers never develop CBD (Document ID 1685, p. 6). However,
Dr. Newman, testifying on behalf of ACOEM, clarified that not all
members of the ACOEM task force agreed:
So I hope I'm reflecting to you the range and variety of
outcomes relating to this. My own view is that it's on a continuum.
I do want to reflect back that the divided opinion among people on
the ACOEM task force was that we should call it a spectrum because
not everybody is necessarily lock step into a continuum that goes
from sensitization to fatality. (Document ID 1756, Tr. 133).
Lisa Maier, MD of National Jewish Health agreed with Dr. Newman
(Document ID 1756, Tr. 133-134). Additionally, Dr. Weissman of NIOSH
testified that sensitization is "a biological change in people exposed
to beryllium that is associated with increased risk for developing
CBD" and should be considered an adverse health effect (Document ID
1755, Tr. 13).
OSHA agrees that not every sensitized worker develops CBD, and that
other factors such as extent of exposure, particulate characteristics,
and genetic susceptibility influence the development and progression of
disease. The mechanisms by which beryllium sensitization leads to CBD
are described in earlier sections and are supported by numerous studies
(Newman et al., 1996a, Document ID 1439; Newman et al., 2005 (1437);
Saltini et al., 1989 (1351); Amicosante et al., 2005a (1564);
Amicosante et al., 2006 (1465); Fontenot et al., 1999 (0489); Fontenot
et al., 2005 (1528)). OSHA concludes that sensitization is an
immunological condition that increases one's likelihood
of developing CBD. As such, sensitization is a necessary step along a
continuum to clinical lung disease.
5. Human Epidemiological Studies
This section describes the human epidemiological data supporting
the mechanistic overview of beryllium-induced disease in workers. It
has been divided into reviews of epidemiological studies performed
prior to development and implementation of the BeLPT in the late 1980s
and after wide use of the BeLPT for screening purposes. Use of the
BeLPT has allowed investigators to screen for beryllium sensitization
and CBD prior to the onset of clinical symptoms, providing a more
sensitive and thorough analysis of the worker population. The
discussion of the studies has been further divided by manufacturing
processes that may have similar exposure profiles. Table A.1 in the
Supplemental Information for the Beryllium Health Effects Section
summarizes the prevalence of beryllium sensitization and CBD, range of
exposure measurements, and other salient information from the key
epidemiological studies (Document ID 1965).
It has been well-established that beryllium exposure, either via
inhalation or skin, may lead to beryllium sensitization, or, with
inhalation exposure, may lead to the onset and progression of CBD. The
available published epidemiological literature discussed below provides
strong evidence of beryllium sensitization and CBD in workers exposed
to airborne beryllium well below the preceding OSHA PEL of 2 μg/
m3\. Several studies demonstrate the prevalence of sensitization and
CBD is related to the level of airborne exposure, including a cross-
sectional survey of employees at a beryllium ceramics plant in Tucson,
AZ (Henneberger et al., 2001, Document ID 1313), case-control studies
of workers at the Rocky Flats nuclear weapons facility (Viet et al.,
2000, Document ID 1344), and workers from a beryllium machining plant
in Cullman, AL (Kelleher et al., 2001, Document ID 1363). The
prevalence of beryllium sensitization also may be related to dermal
exposure. An increased risk of CBD has been reported in workers with
skin lesions, potentially increasing the uptake of beryllium (Curtis,
1951, Document ID 1368; Johnson et al., 2001 (1505); Schuler et al.,
2005 (0919)). Three studies describe comprehensive preventive programs,
which included expanded respiratory protection, dermal protection, and
improved control of beryllium dust migration, that substantially
reduced the rate of beryllium sensitization among new hires (Cummings
et al., 2007; Thomas et al., 2009 (0590); Bailey et al., 2010 (0676);
Schuler et al., 2012(0473)).
Some of the epidemiological studies presented in this section
suffer from challenges common to many published epidemiological
studies: Limitations in study design (particularly cross-sectional);
small sample size; lack of personal and/or short-term exposure data,
particularly those published before the late 1990s; and incomplete
information regarding specific chemical form and/or particle
characterization. Challenges that are specific to beryllium
epidemiological studies include: uncertainty regarding the contribution
of dermal exposure; use of various BeLPT protocols; a variety of case
definitions for determining CBD; and use of various exposure sampling/
assessment methods (e.g., daily weighted average (DWA), lapel
sampling). Even with these limitations, the epidemiological evidence
presented in this section clearly demonstrates that beryllium
sensitization and CBD are continuing to occur from present-day
exposures below OSHA's preceding PEL of 2 μg/m3\. The available
literature also indicates that the rate of beryllium sensitization can
be substantially lowered by reducing inhalation exposure and minimizing
dermal contact.
a. Studies Conducted Prior to the BeLPT
First reports of CBD came from studies performed by Hardy and
Tabershaw (1946) (Document ID 1516). Cases were observed in industrial
plants that were refining and manufacturing beryllium metal and
beryllium alloys and in plants manufacturing fluorescent light bulbs
(NAS, 2008, Document ID 1355). From the late 1940s through the 1960s,
clusters of non-occupational CBD cases were identified around beryllium
refineries in Ohio and Pennsylvania, and outbreaks in family members of
beryllium factory workers were assumed to be from exposure to
contaminated clothes (Hardy, 1980, Document ID 1514). It had been
established that the risk of disease among beryllium workers was
variable and generally rose with the levels of airborne concentrations
(Machle et al., 1948, Document ID 1461). And while there was a
relationship between air concentrations of beryllium and risk of
developing disease both in and surrounding these plants, the disease
rates outside the plants were higher than expected and not very
different from the rate of CBD within the plants (Eisenbud et al.,
1949, Document ID 1284; Lieben and Metzner, 1959 (1343)). There
remained considerable uncertainty regarding diagnosis due to lack of
well-defined cohorts, modern diagnostic methods, or inadequate follow-
up. In fact, many patients with CBD may have been misdiagnosed with
sarcoidosis (NAS, 2008, Document ID 1355).
The difficulties in distinguishing lung disease caused by beryllium
from other lung diseases led to the establishment of the BCR in 1952 to
identify and track cases of ABD and CBD. A uniform diagnostic criterion
was introduced in 1959 as a way to delineate CBD from sarcoidosis.
Patient entry into the BCR required either: Documented past exposure to
beryllium or the presence of beryllium in lung tissue as well as
clinical evidence of beryllium disease (Hardy et al., 1967, Document ID
1515); or any three of the six criteria listed below (Hasan and Kazemi,
1974, Document ID 0451). Patients identified using the above criteria
were registered and added to the BCR from 1952 through 1983 (Eisenbud
and Lisson, 1983, Document ID 1296).
The BCR listed the following criteria for diagnosing CBD (Eisenbud
and Lisson, 1983, Document ID 1296):
(1) Establishment of significant beryllium exposure based on sound
epidemiologic history;
(2) Objective evidence of lower respiratory tract disease and
clinical course consistent with beryllium disease;
(3) Chest X-ray films with radiologic evidence of interstitial
fibronodular disease;
(4) Evidence of restrictive or obstructive defect with diminished
carbon monoxide diffusing capacity (DL CO) by physiologic
studies of lung function;
(5) Pathologic changes consistent with beryllium disease on
examination of lung tissue; and
(6) Presence of beryllium in lung tissue or thoracic lymph nodes.
Prevalence of CBD in workers during the time period between the
1940s and 1950s was estimated to be between 1-10% (Eisenbud and Lisson,
1983, Document ID 1296). In a 1969 study, Stoeckle et al. presented 60
case histories with a selective literature review utilizing the above
criteria except that urinary beryllium was substituted for lung
beryllium to demonstrate beryllium exposure. Stoeckle et al. (1969)
were able to demonstrate corticosteroids as a successful treatment
option in one case of confirmed CBD (Document ID 0447). This study also
presented a 28 percent mortality rate from complications of CBD at the
time of publication. However, even with the improved
methodology for determining CBD based on the BCR criteria, these
studies suffered from lack of well-defined cohorts, modern diagnostic
techniques or adequate follow-up.
b. Criteria for Beryllium Sensitization and CBD Case Definition
Following the Development of the BeLPT
The criteria for diagnosis of CBD have evolved over time as more
advanced diagnostic technology, such as the blood BeLPT and BAL BeLPT,
has become available. More recent diagnostic criteria have both higher
specificity than earlier methods and higher sensitivity, identifying
subclinical effects. Recent studies typically use the following
criteria (Newman et al., 1989, Document ID 0196; Pappas and Newman,
1993 (1433); Maier et al., 1999 (1458)):
(1) History of beryllium exposure;
(2) Histopathological evidence of non-caseating granulomas or
mononuclear cell infiltrates in the absence of infection; and
(3) Positive blood or BAL BeLPT (Newman et al., 1989, Document ID
0196).
The availability of transbronchial lung biopsy facilitates the
evaluation of the second criterion, by making histopathological
confirmation possible in almost all cases.
A significant component for the identification of CBD is the
demonstration of a confirmed abnormal BeLPT result in a blood or BAL
sample (Newman, 1996, Document ID 1283). Since the development of the
BeLPT in the 1980s, it has been used to screen beryllium-exposed
workers for sensitization in a number of studies to be discussed below.
The BeLPT is a non-invasive in vitro blood test that measures the
beryllium antigen-specific T-cell mediated immune response and is the
most commonly available diagnostic tool for identifying beryllium
sensitization. The BeLPT measures the degree to which beryllium
stimulates lymphocyte proliferation under a specific set of conditions,
and is interpreted based upon the number of stimulation indices that
exceed the normal value. The "cut-off" is based on the mean value of
the peak stimulation index among controls plus 2 or 3 standard
deviations. This methodology was modeled into a statistical method
known as the "least absolute values" or "statistical-biological
positive" method and relies on natural log modeling of the median
stimulation index values (DOE, 2001, Document ID 0068; Frome, 2003
(0462)). In most applications, two or more stimulation indices that
exceed the cut-off constitute an abnormal test.
Early versions of the BeLPT test had high variability, but the use
of tritiated thymidine to identify proliferating cells has led to a
more reliable test (Mroz et al., 1991, 0435; Rossman et al., 2001
(1424)). In recent years, the peripheral blood test has been found to
be as sensitive as the BAL assay, although larger abnormal responses
have been observed with the BAL assay (Kreiss et al., 1993, Document ID
1478; Pappas and Newman, 1993 (1433)). False negative results have also
been observed with the BAL BeLPT in cigarette smokers who have marked
excess of alveolar macrophages in lavage fluid (Kreiss et al., 1993,
Document ID 1478). The BeLPT has also been a useful tool in animal
studies to identify those species with a beryllium-specific immune
response (Haley et al., 1994, Document ID 1364).
Screenings for beryllium sensitization have been conducted using
the BeLPT in several occupational surveys and surveillance programs,
including nuclear weapons facilities operated by the Department of
Energy (Viet et al., 2000, Document ID 1344; Stange et al., 2001
(1403); DOE/HSS Report, 2006 (0664)), a beryllium ceramics plant in
Arizona (Kreiss et al., 1996, Document ID 1477; Henneberger et al.,
2001 (1313); Cummings et al., 2007 (1369)), a beryllium production
plant in Ohio (Kreiss et al., 1997, Document ID 1476; Kent et al., 2001
(1112)), a beryllium machining facility in Alabama (Kelleher et al.,
2001, Document ID 1363; Madl et al., 2007 (1056)), a beryllium alloy
plant (Schuler et al., 2005, Document ID 0473; Thomas et al., 2009
(0590)), and another beryllium processing plant (Rosenman et al., 2005,
Document ID 1352) in Pennsylvania. In most of these studies,
individuals with an abnormal BeLPT result were retested and were
identified as sensitized (i.e., confirmed positive) if the abnormal
result was repeated.
In order to investigate the reliability and laboratory variability
of the BeLPT, Stange et al. (2004, Document ID 1402) studied the BeLPT
by splitting blood samples and sending samples to two laboratories
simultaneously for BeLPT analysis. Stange et al. found the range of
agreement on abnormal (positive BeLPT) results was 26.2--61.8 percent
depending upon the labs tested (Stange et al., 2004, Document ID 1402).
Borak et al. (2006) contended that the positive predictive value (PPV)
4 is not high enough to meet the criteria of a good screening tool
(Document ID 0498). Middleton et al. (2008) used the data from the
Stange et al. (2004) study to estimate the PPV and determined that the
PPV of the BeLPT could be improved from 0.383 to 0.968 when an abnormal
BeLPT result is confirmed with a second abnormal result (Middleton et
al., 2008, Document ID 0480). In April 2006, the Agency for Toxic
Substances and Disease Registry (ATSDR) convened an expert panel of
seven physicians and scientists to discuss the BeLPT and to consider
what algorithm should be used to interpret BeLPT results to establish
beryllium sensitization (Middleton et al., 2008, Document ID 0480). The
three criteria proposed by panel members were Criterion A (one abnormal
BeLPT result establishes sensitization); Criterion B (one abnormal and
one borderline result establish sensitization); and Criterion C (two
abnormal results establish sensitization). Using the single-test
outcome probabilities developed by Stange et al., the panel convened by
ATSDR calculated and compared the sensitivity, specificity, and
positive predictive values (PPVs) for each algorithm. The
characteristics for each algorithm were as follows:
---------------------------------------------------------------------------
4 PPV is the portion of patients with positive test result
correctly diagnosed.
Table 2--Characteristics of BeLPT Algorithms (Adapted from Middleton et al., (2008)
[Adapted from Middleton et al., 2008, Document ID 0480]
----------------------------------------------------------------------------------------------------------------
Criterion B
Criterion A (1 abnormal + Criterion C
(1 abnormal) 1 borderline) (2 abnormal)
----------------------------------------------------------------------------------------------------------------
Sensitivity..................................................... 68.2% 65.7% 61.2%
Specificity..................................................... 98.89% 99.92% 99.98%
PPV at 1% prevalence............................................ 38.3% 89.3% 96.8%
PPV at 10% prevalence........................................... 87.2% 98.9% 99.7%
False positives per 10,000...................................... 111 8 2
----------------------------------------------------------------------------------------------------------------
The Middleton et al. (2008) study demonstrated that confirmation of
BeLPT results, whether as one abnormal and one borderline abnormal or
as two abnormals, enhances the test's PPV and protects the persons
tested from unnecessary and invasive medical procedures. In populations
with a high prevalence of beryllium sensitization (i.e., 10 percent or
more), however, a single test may be adequate to predict sensitization
(Middleton et al., 2008, Document ID 0480).
Still, there has been criticism regarding the reliability and
specificity of the BeLPT as a screening tool and that the BeLPT has not
been validated appropriately (Cher et al., 2006, as cited in Document
ID 1678; Borak et al., 2006 (0498); Donovan et al., 2007 (0491);
Document ID 1678, Attachment 1, p. 6). Even when a confirmational
second test is performed, an apparent false positive can occur in
people not occupationally exposed to beryllium (NAS, 2008, Document ID
1355). An analysis of survey data from the general workforce and new
employees at a beryllium manufacturer was performed to assess the
reliability of the BeLPT (Donovan et al. 2007, Document ID 0491).
Donovan et al. analyzed more than 10,000 test results from nearly 2400
participants over a 12-year period. Donovan et al. found that
approximately 2 percent of new employees had at least one positive
BeLPT at the time of hire and 1 percent of new hires with no known
occupational exposure were confirmed positive at the time of hire with
two BeLPTs. However, this should not be considered unusual because
there have been reported incidences of non-occupational and community-
based beryllium sensitization (Eisenbud et al., 1949, Document ID 1284;
Leiben and Metzner, 1959 (1343); Newman and Kreiss, 1992 (1440); Maier
and Rossman, 2008 (0598); NAS, 2008 (1355); Harber et al., 2014 (0415),
Harber et al., 2014 (0421)).
Materion objected to OSHA treating "two or three uninterpretable
or borderline abnormal BeLPT test results as confirmation of BeS for
the purposes of the standard" (Document ID 1808, p. 4). In order to
address some criticism regarding the PPV of the BeLPT, Middleton et al.
(2011) conducted another study to evaluate borderline results from
BeLPT testing (Document ID 0399). Utilizing the common clinical
algorithm with a criterion that accepted one abnormal result and one
borderline result as establishing beryllium sensitization resulted in a
PPV of 94.4 percent. This study also found that three borderline
results resulted in a PPV of 91 percent. Both of these PPVs were based
on a population prevalence of 2 percent. This study further
demonstrates the value of borderline results in predicting beryllium
sensitization using the BeLPT. OSHA finds that multiple, consistent
borderline BeLPT results (as found with three borderline results)
recognize a change in a person's immune system to beryllium exposure.
In addition, a study by Harber et al. (2014) reexamined the algorithms
to determine sensitization and CBD data using the BioBank data.5 The
study suggested that changing the algorithm could potentially help
distinguish sensitization from progression to CBD (Harber et al., 2014,
Document ID 0363).
---------------------------------------------------------------------------
5 BioBank is a repository of biological specimens and clinical
data collected from beryllium-exposed Department of Energy workers
and contractors.
---------------------------------------------------------------------------
Materion further contended that "[w]hile some refer to BeLPT
testing as a `gold' standard for BeS, it is hardly `golden,' as
numerous commentators have noted." (Document ID 1808, p. 4). NIOSH
submitted testimony to OSHA comparing the use of the BeLPT for
determining beryllium sensitization to other common medical screening
tools such as mammography for breast cancer, tuberculin skin test for
latent tuberculosis infection, prostate-specific antigen (PSA) for
prostate cancer, and fecal occult blood testing for colon cancer. NIOSH
stated that "[a]lthough there is no gold standard test to identify
beryllium sensitization, BeLPT has been estimated to have a sensitivity
of 66-86% and a specificity of >99% for sensitization [Middleton et al.
(2006)]. These values are comparable or superior to those of other
common medical screening tests." (Document ID 1725, pp. 32-33). In
addition, Dr. Maier of National Jewish Health stated during the public
hearing that "medical surveillance should rely on the BeLPT or a
similar test if validated in the future, as it detects early and late
beryllium health effects. It has been validated in many population-
based studies." (Document ID 1756, Tr. 103).
Since there are currently no alternatives to the BeLPT in a
beryllium sensitization screening program, many programs rely on a
second test to confirm a positive result (NAS, 2008). Various expert
organizations support the use of the BeLPT (with a second
confirmational test) as a screening tool for beryllium sensitization
and CBD. The American Thoracic Society (ATS), based on a systematic
review of the literature, noted that "the BeLPT is the cornerstone of
medical surveillance" (Balmes et al., 2014; Document ID 0364, pp. 1-
2). The use of the BeLPT in medical surveillance has been endorsed by
the National Academies in their review of beryllium-related diseases
and disease prevention programs for the U. S. Air Force (NAS, 2008,
Document ID 1355). In 2011, NIOSH issued an alert "Preventing
Sensitization and Disease from Beryllium Exposure" where the BeLPT is
recommended as part of a medical screening and surveillance program
(NIOSH, 2011, Document ID 0544). OSHA finds that the BeLPT is a useful
and reliable test method that has been utilized in numerous studies and
validated and improved through multiple studies.
The epidemiological studies presented in this section utilized the
BeLPT as either a surveillance tool or a screening tool for determining
sensitization status and/or sensitization/CBD prevalence in workers for
inclusion in the published studies. Most epidemiological studies have
reported rates of sensitization and disease based on a single screening
of a working population ("cross-sectional" or "population
prevalence" rates). Studies of workers in a beryllium machining plant
and a nuclear weapons facility have included follow-up of the
population originally screened, resulting in the detection of
additional cases of sensitization over several years (Newman et al.,
2001, Document ID 1354; Stange et al., 2001 (1403)). Based on the
studies above, as well as comments from NIOSH, ATS, and National Jewish
Health, OSHA regards
the BeLPT as a reliable medical surveillance tool.
c. Beryllium Mining and Extraction
Mining and extraction of beryllium usually involves the two major
beryllium minerals, beryl (an aluminosilicate containing up to 4
percent beryllium) and bertrandite (a beryllium silicate hydrate
containing generally less than 1 percent beryllium) (WHO, 2001,
Document ID 1282). The United States is the world leader in beryllium
extraction and also leads the world in production and use of beryllium
and its alloys (WHO, 2001, Document ID 1282). Most exposures from
mining and extraction come in the form of beryllium ore, beryllium
salts, beryllium hydroxide (NAS, 2008, Document ID 1355) or beryllium
oxide (Stefaniak et al., 2008, Document ID 1397).
Deubner et al. published a study of 75 workers employed at a
beryllium mining and extraction facility in Delta, UT (Deubner et al.,
2001b, Document ID 1543). Of the 75 workers surveyed for sensitization
with the BeLPT, three were identified as sensitized by an abnormal
BeLPT result. One of those found to be sensitized was diagnosed with
CBD. Exposures at the facility included primarily beryllium ore and
salts. General area (GA), breathing zone (BZ), and personal lapel (LP)
exposure samples were collected from 1970 to 1999. Jobs involving
beryllium hydrolysis and wet-grinding activities had the highest air
concentrations, with an annual median GA concentration ranging from 0.1
to 0.4 μg/m3\. Median BZ concentrations were higher than either LP
or GA concentrations. The average duration of exposure for beryllium
sensitized workers was 21.3 years (27.7 years for the worker with CBD),
compared to an average duration for all workers of 14.9 years. However,
these exposures were less than either the Elmore, OH, or Tucson, AZ,
facilities described below, which also had higher reported rates of BeS
and CBD. A study by Stefaniak et al. (2008) demonstrated that beryllium
was present at the mill in three forms: Mineral, poorly crystalline
oxide, and hydroxide (Document ID 1397).
There was no sensitization or CBD among those who worked only at
the mine where exposure to beryllium resulted solely from working with
bertrandite ore. The authors concluded that the results of this study
indicated that beryllium ore and salts may pose less of a hazard than
beryllium metal and beryllium hydroxide. These results are consistent
with the previously discussed animal studies examining solubility and
particle size.
d. Beryllium Metal Processing and Alloy Production
Kreiss et al. (1997) conducted a study of workers at a beryllium
production facility in Elmore, OH (Document ID 1360). The plant, which
opened in 1953 and initially specialized in production of beryllium-
copper alloy, later expanded its operations to include beryllium metal,
beryllium oxide, and beryllium-aluminum alloy production; beryllium and
beryllium alloy machining; and beryllium ceramics production, which was
moved to a different factory in the early 1980s. Production operations
included a wide variety of jobs and processes, such as work in arc
furnaces and furnace rebuilding, alloy melting and casting, beryllium
powder processing, and work in the pebble plant. Non-production work
included jobs in the analytical laboratory, engineering research and
development, maintenance, laundry, production-area management, and
office-area administration. While the publication refers to the use of
respiratory protection in some areas, such as the pebble plant, the
extent of its use across all jobs or time periods was not reported. Use
of dermal PPE was not reported.
The authors characterized exposures at the plant using industrial
hygiene (IH) samples collected between 1980 and 1993. The exposure
samples and the plant's formulas for estimating workers' DWA exposures
were used, together with study participants' work histories, to
estimate their cumulative and average beryllium exposure levels.
Exposure concentrations reflected the high exposures found historically
in beryllium production and processing. Short-term BZ measurements had
a median of 1.4 μg/m3\, with 18.5 percent of samples exceeding
OSHA's preceding permissible ceiling concentration of 5.0 μg/m3\.
Particularly high beryllium concentrations were reported in the areas
of beryllium powder production, laundry, alloy arc furnace
(approximately 40 percent of DWA estimates over 2.0 μg/m3\) and
furnace rebuild (28.6 percent of short-term BZ samples over the
preceding OSHA permissible ceiling concentration of 5 μg/m3\). LP
samples (n = 179), which were available from 1990 to 1992, had a median
value of 1 μg/m3\.
Of 655 workers employed at the time of the study, 627 underwent
BeLPT screening. Blood samples were divided and split between two labs
for analysis, with repeat testing for results that were abnormal or
indeterminate. Thirty-one workers had an abnormal blood test result
upon initial testing and at least one of two subsequent test results
for each of those workers confirmed the worker as sensitized. These
workers, together with 19 workers who had an initial abnormal result
and one subsequent indeterminate result, were offered clinical
evaluation for CBD including the BAL-BeLPT and transbronchial lung
biopsy. Nine workers with an initial abnormal test followed by two
subsequent normal tests were not clinically evaluated, although four
were found to be sensitized upon retesting in 1995. Of 47 workers who
proceeded with evaluation for CBD (3 of the 50 initial workers with
abnormal results declined to participate), 24 workers were diagnosed
with CBD based on evidence of granulomas on lung biopsy (20 workers) or
on other findings consistent with CBD (4 workers) (Kreiss et al., 1997,
Document ID 1360). After including five workers who had been diagnosed
prior to the study, a total of 29 (4.6 percent of the 627 workers who
underwent BeLPT screening) workers still employed at the time of the
study were found to have CBD. In addition, the plant medical department
identified 24 former workers diagnosed with CBD before the study.
Kreiss et al. reported that the highest prevalence of sensitization
and CBD occurred among workers employed in beryllium metal production,
even though the highest airborne total mass concentrations of beryllium
were generally among employees operating the beryllium alloy furnaces
in a different area of the plant (Kreiss et al., 1997, Document ID
1360). Preliminary follow-up investigations of particle size-specific
sampling at five furnace sites within the plant determined that the
highest respirable (i.e., particles <10 μm in diameter as defined by
the authors) and alveolar-deposited (i.e., particles <1 μm in
diameter as defined by the authors) beryllium mass and particle number
concentrations, as collected by a general area impactor device, were
measured at the beryllium metal production furnaces rather than the
beryllium alloy furnaces (Kent et al., 2001, Document ID 1361; McCawley
et al., 2001 (1357)). A statistically significant linear trend was
reported between the above alveolar-deposited particle mass
concentration and prevalence of CBD and sensitization in the furnace
production areas. The authors concluded that alveolar-deposited
particles may be a more relevant exposure metric for predicting the
incidence of CBD or sensitization
than the total mass concentration of airborne beryllium.
Bailey et al. (2010) (Document ID 0610) evaluated the effectiveness
of a workplace preventive program in lowering incidences of
sensitization at the beryllium metal, oxide, and alloy production plant
studied by Kreiss et al. (1997) (Document ID 1360). The preventive
program included use of administrative and PPE controls (e.g., improved
training, skin protection and other PPE, half-mask or air-purified
respirators, medical surveillance, improved housekeeping standards,
clean uniforms) as well as engineering and administrative controls
(e.g., migration controls, physical separation of administrative
offices from production facilities) implemented over the course of five
years.
In a cross-sectional/longitudinal hybrid study, Bailey et al.
compared rates of sensitization in pre-program workers to those hired
after the preventive program began. Pre-program workers were surveyed
cross-sectionally in 1993-1994, and again in 1999 using the BeLPT to
determine sensitization and CBD prevalence rates. The 1999 cross-
sectional survey was conducted to determine if improvements in
engineering and administrative controls were successful. However,
results indicated no improvement in reducing rates of sensitization or
CBD.
An enhanced preventive program including particle migration
control, respiratory and dermal protection, and process enclosure was
implemented in 2000, with continuing improvements made to the program
in 2001, 2002-2004, and 2005. Workers hired during this period were
longitudinally surveyed for sensitization using the BeLPT. Both the
pre-program and program survey of worker sensitization status utilized
split-sample testing to verify positive test results using the BeLPT.
Of the total 660 workers employed at the production plant, 258 workers
participated from the pre-program group while 290 participated from the
program group (206 partial program, 84 full program). Prevalence
comparisons of the pre-program and program groups (partial and full)
were performed by calculating prevalence ratios. A 95 percent
confidence interval (95 percent CI) was derived using a cohort study
method that accounted for the variance in survey techniques (cross-
sectional versus longitudinal) (Bailey et al., 2010). The sensitization
prevalence of the pre-program group was 3.8 times higher (95 percent
CI, 1.5-9.3) than the program group, 4.0 times higher (95 percent CI,
1.4-11.6) than the partial program subgroup, and 3.3 times higher (95
percent CI, 0.8-13.7) than the full program subgroup indicating that a
comprehensive preventive program can reduce, but not eliminate,
occurrence of sensitization among non-sensitized workers (Bailey et
al., 2010, Document ID 0610).
Rosenman et al. (2005) studied a group of several hundred workers
who had been employed at a beryllium production and processing facility
that operated in eastern Pennsylvania between 1957 and 1978 (Document
ID 1352). Of 715 former workers located, 577 were screened for
beryllium sensitization with the BLPT and 544 underwent chest
radiography to identify cases of beryllium sensitization and CBD.
Workers were reported to have exposure to beryllium dust and fume in a
variety of chemical forms including beryl ore, beryllium metal,
beryllium fluoride, beryllium hydroxide, and beryllium oxide.
Rosenman et al. used the plant's DWA formulas to assess workers'
full-shift exposure levels, based on IH data collected between 1957-
1962 and 1971-1976, to calculate exposure metrics including cumulative,
average, and peak for each worker in the study (Document ID 1352). The
DWA was calculated based on air monitoring that consisted of GA and
short-term task-based BZ samples. Workers' exposures to specific
chemical and physical forms of beryllium were assessed, including
poorly soluble beryllium (metal and oxide), soluble beryllium (fluoride
and hydroxide), mixed soluble and poorly soluble beryllium, beryllium
dust (metal, hydroxide, or oxide), fume (fluoride), and mixed dust and
fume. Use of respiratory or dermal protection by workers was not
reported. Exposures in the plant were high overall. Representative
task-based IH samples ranged from 0.9 μg/m3\ to 84 μg/m3\ in
the 1960s, falling to a range of 0.5-16.7 μg/m3\ in the 1970s. A
large number of workers' mean DWA estimates (25 percent) were above the
preceding OSHA PEL of 2.0 μg/m3\, while most workers had mean DWA
exposures between 0.2 and 2.0 μg/m3\ (74 percent) or below 0.02
μg/m3\ (1 percent) (Rosenman et al., Table 11; revised erratum
April, 2006, Document ID 1352).
Blood samples for the BeLPT were collected from the former workers
between 1996 and 2001 and were evaluated at a single laboratory.
Individuals with an abnormal test result were offered repeat testing,
and were classified as sensitized if the second test was also abnormal.
Sixty workers with two positive BeLPTs and 50 additional workers with
chest radiography suggestive of disease were offered clinical
evaluation, including bronchoscopy with bronchial biopsy and BAL-BeLPT.
Seven workers met both criteria. Only 56 (51 percent) of these workers
proceeded with clinical evaluation, including 57 percent of those
referred on the basis of confirmed abnormal BeLPT and 47 percent of
those with abnormal radiographs (Document ID 1352).
Of the 577 workers who were evaluated for CBD, 32 (5.5 percent)
with evidence of granulomas were classified as "definite" CBD cases
(as identified by bronchoscopy). Twelve (2.1 percent) additional
workers with positive BAL-BeLPT or confirmed positive BeLPT and
radiographic evidence of upper lobe fibrosis were classified as
"probable" CBD cases. Forty workers (6.9 percent) without upper lobe
fibrosis who had confirmed abnormal BeLPT, but who were not biopsied or
who underwent biopsy with no evidence of granuloma, were classified as
sensitized without disease. It is not clear how many of those 40
workers underwent biopsy. Another 12 (2.1 percent) workers with upper
lobe fibrosis and negative or unconfirmed positive BeLPT were
classified as "possible" CBD cases. Nine additional workers who were
diagnosed with CBD before the screening were included in some parts of
the authors' analysis (Document ID 1352).
The authors reported a total prevalence of 14.5 percent for CBD
(definite and probable) and sensitization. This rate, considerably
higher than the overall prevalence of sensitization and disease in
several other worker cohorts as described earlier in this section,
reflects in part the very high exposures experienced by many workers
during the plant's operation in the 1950s, 1960s and 1970s. A total of
115 workers had mean DWAs above the preceding OSHA PEL of 2 μg/m3\.
Of those, seven (6.0 percent) had definite or probable CBD and another
13 (11 percent) were classified as sensitized without disease. The true
prevalence of CBD in the group may be higher than reported, due to the
low rate of clinical evaluation among sensitized workers (Document ID
1352).
Although most of the workers in this study had high exposures,
sensitization and CBD also were observed within the small subgroup of
participants believed to have relatively low beryllium exposures.
Thirty-three cases of CBD and 24 additional cases of sensitization
occurred among 339 workers with mean DWA exposures below OSHA's PEL of
2.0 μg/m3\ (Rosenman et al., Table 11, erratum 2006, Document ID
1352). Ten cases of sensitization and five cases of
CBD were found among office and clerical workers, who were believed to
have low exposures (levels not reported).
Follow-up time for sensitization screening of workers in this study
who became sensitized during their employment had a minimum of 20 years
to develop CBD prior to screening. In this sense the cohort is
especially well suited to compare the exposure patterns of workers with
CBD and those sensitized without disease, in contrast to several other
studies of workers with only recent beryllium exposures. Rosenman et
al. characterized and compared the exposures of workers with definite
and probable CBD, sensitization only, and no disease or sensitization
using chi-squared tests for discrete outcomes and analysis of variance
(ANOVA) for continuous variables (cumulative, mean, and peak exposure
levels). Exposure-response relationships were further examined with
logistic regression analysis, adjusting for potential confounders
including smoking, age, and beryllium exposure from outside of the
plant. The authors found that cumulative, peak, and duration of
exposure were significantly higher for workers with CBD than for
sensitized workers without disease (p <0.05), suggesting that the risk
of progressing from sensitization to CBD is related to the level or
extent of exposure a worker experiences. The risk of developing CBD
following sensitization appeared strongly related to exposure to poorly
soluble forms of beryllium, which are cleared slowly from the lung and
increase beryllium lung burden more rapidly than quickly mobilized
soluble forms. Individuals with CBD had higher exposures to poorly
soluble beryllium than those classified as sensitized without disease,
while exposure to soluble beryllium was higher among sensitized
individuals than those with CBD (Document ID 1352).
Cumulative, mean, peak, and duration of exposure were found to be
comparable for workers with CBD and workers without sensitization or
CBD ("normal" workers). Cumulative, peak, and duration of exposure
were significantly lower for sensitized workers without disease than
for normal workers. Rosenman et al. suggested that genetic
predisposition to sensitization and CBD may have obscured an exposure-
response relationship in this study, and plan to control for genetic
risk factors in future studies. Exposure misclassification from the
1950s and 1960s may have been another limitation in this study,
introducing bias that could have influenced the lack of exposure
response. It is also unknown if the 25 percent who died from CBD-
related conditions may have had higher exposures (Document ID 1352).
A follow-up was conducted of the cross-sectional study of a
population of workers first evaluated by Kreiss et al. (1997) (Document
ID 1360) and Rosenman et al. (2005) (Document ID 1352) by Schuler et
al. (2012) (Document ID 0473), and in a companion study by Virji et al.
(2012) (Document ID 0466). Schuler et al. evaluated the worker
population employed in 1999 with six years or less work tenure in a
cross-sectional study. The investigators evaluated the worker
population by administering a work history questionnaire with a follow-
up examination for sensitization and CBD. A job-exposure matrix (JEM)
was combined with work histories to create individual estimates of
average, cumulative, and highest-job-related exposure for total,
respirable, and sub-micron beryllium mass concentration. Of the 291
eligible workers, 90.7 percent (264) participated in the study.
Sensitization prevalence was 9.8 percent (26/264) with CBD prevalence
of 2.3 percent (6/264). The investigators found a general pattern of
increasing sensitization prevalence as the exposure quartile increased
indicating an exposure-response relationship. The investigators found
positive associations with both total and respirable mass concentration
with sensitization (average and highest job) and CBD (cumulative).
Increased sensitization prevalence was observed with metal oxide
production alloy melting and casting, and maintenance. CBD was
associated with melting and casting. The investigators summarized that
both total and respirable mass concentration were relevant predictors
of risk (Schuler et al., 2012, Document ID 0473).
In the companion study by Virji et al. (2012), the investigators
reconstructed historical exposure from 1994 to 1999 utilizing the
personal sampling data collected in 1999 as baseline exposure estimates
(BEE) (Document ID 0466). The study evaluated techniques for
reconstructing historical data to evaluate exposure-response
relationships for epidemiological studies. The investigators
constructed JEMs using the BEE and estimates of annual changes in
exposure for 25 different process areas. The investigators concluded
these reconstructed JEMs could be used to evaluate a range of exposure
parameters from total, respirable and submicron mass concentration
including cumulative, average, and highest exposure.
e. Beryllium Machining Operations
Newman et al. (2001) (Document ID 1354) and Kelleher et al. (2001)
(Document ID 1363) studied a group of 235 workers at a beryllium metal
machining plant. Since the plant opened in 1969, its primary operations
have been machining and polishing beryllium metal and high-beryllium
content composite materials, with occasional machining of beryllium
oxide/metal matrix (`E-metal'), and beryllium alloys. Other functions
include machining of metals other than beryllium; receipt and
inspection of materials; acid etching; final inspection, quality
control, and shipping of finished materials; tool making; and
engineering, maintenance, administrative, and supervisory functions
(Newman et al., 2001, Document ID 1354; Madl et al., 2007 (1056)).
Machining operations, including milling, grinding, lapping, deburring,
lathing, and electrical discharge machining (EDM) were performed in an
open-floor plan production area. Most non-machining jobs were located
in a separate, adjacent area; however, non-production employees had
access to the machining area.
Engineering and administrative controls, rather than PPE, were
primarily used to control beryllium exposures at the plant (Madl et
al., 2007, Document ID 1056). Based on interviews with long-standing
employees of the plant, Kelleher et al. reported that work practices
were relatively stable until 1994, when a worker was diagnosed with CBD
and a new exposure control program was initiated. Between 1995 and
1999, new engineering and work practice controls were implemented,
including removal of pressurized air hoses and discouragement of dry
sweeping (1995), enclosure of deburring processes (1996), mandatory
uniforms (1997), and installation or updating of local exhaust
ventilation (LEV) in EDM, lapping, deburring, and grinding processes
(1998) (Madl et al., 2007, Document ID 1056). Throughout the plant's
history, respiratory protection was used mainly for "unusually large,
anticipated exposures" to beryllium (Kelleher et al., 2001, Document
ID 1363), and was not routinely used otherwise (Newman et al., 2001,
Document ID 1354).
All workers at the plant participated in a beryllium disease
surveillance program initiated in 1994, and were screened for beryllium
sensitization with the BeLPT beginning in 1995. A BeLPT result was
considered abnormal if two or more of six stimulation indices exceeded
the normal range (see section
on BeLPT testing above), and was considered borderline if one of the
indices exceeded the normal range. A repeat BeLPT was conducted for
workers with abnormal or borderline initial results. Workers were
identified as beryllium sensitized and referred for a clinical
evaluation, including BAL and transbronchial lung biopsy, if the repeat
test was abnormal. CBD was diagnosed upon evidence of sensitization
with granulomas or mononuclear cell infiltrates in the lung tissue
(Newman et al., 2001, Document ID 1354). Following the initial plant-
wide screening, plant employees were offered BeLPT testing at two-year
intervals. Workers hired after the initial screening were offered a
BeLPT within 3 months of their hire date, and at 2-year intervals
thereafter (Madl et al., 2007, Document ID 1056).
Kelleher et al. performed a nested case-control study of the 235
workers evaluated in Newman et al. (2001) to evaluate the relationship
between beryllium exposure levels and risk of sensitization and CBD
(Kelleher et al., 2001, Document ID 1363). The authors evaluated
exposures at the plant using IH samples they had collected between 1996
and 1999, using personal cascade impactors designed to measure the mass
of beryllium particles less than 6 μm in diameter, particles less
than 1 μm in diameter, and total mass. The great majority of
workers' exposures were below the preceding OSHA PEL of 2 μg/m3\.
However, a few higher exposure levels were observed in machining jobs
including deburring, lathing, lapping, and grinding. Based on a
statistical comparison between their samples and historical data
provided by the plant, the authors concluded that worker beryllium
exposures across all time periods included in the study parameters
(1981 to 1984, 1995 to 1997, and 1998 to 1999) could be approximated
using the 1996-1999 data. They estimated workers' cumulative and
"lifetime weighted" (LTW) beryllium exposure based on the exposure
samples they collected for each job in 1996-1999 and company records of
each worker's job history.
Twenty workers with beryllium sensitization or CBD (cases) were
compared to 206 workers (controls) for the case-control analysis from
the study evaluating workers originally conducted by Newman et al. Of
the 20 workers composing the case group, thirteen workers were
diagnosed with CBD based on lung biopsy evidence of granulomas and/or
mononuclear cell infiltrates (11) or positive BAL results with evidence
of lymphocytosis (2). The other seven were evaluated for CBD and found
to be sensitized only. Nine of the remaining 215 workers first
identified in original study (Newman et al., 2001, Document ID 1354)
were excluded due to incomplete job history information, leaving 206
workers in the control group.
Kelleher et al.'s analysis included comparisons of the case and
control groups' median exposure levels; calculation of odds ratios for
workers in high, medium, and low exposure groups; and logistic
regression testing of the association of sensitization or CBD with
exposure level and other variables. Median cumulative exposures for
total mass, particles less than 6 μm in diameter, and particles less
than 1 μm in diameter were approximately three times higher among
the cases than controls, although the relationships observed were not
statistically significant (p values ~ 0.2). No clear difference between
cases and controls was observed for the median LTW exposures. Odds
ratios with sensitization and CBD as outcomes were elevated in high
(upper third) and intermediate exposure groups relative to low (lowest
third) exposure groups for both cumulative and LTW exposure, though the
results were not statistically significant (p >0.1). In the logistic
regression analysis, only machinist work history was a significant
predictor of case status in the final model. Quantitative exposure
measures were not significant predictors of sensitization or disease
risk.
Citing an 11.5 percent prevalence of beryllium sensitization or CBD
among machinists as compared with 2.9 percent prevalence among workers
with no machinist work history, the authors concluded that the risk of
sensitization and CBD is increased among workers who machine beryllium.
Although differences between cases and controls in median cumulative
exposure did not achieve conventional thresholds for statistical
significance, the authors noted that cumulative exposures were
consistently higher among cases than controls for all categories of
exposure estimates and for all particle sizes, suggesting an effect of
cumulative exposure on risk. The levels at which workers developed CBD
and sensitization were predominantly below OSHA's preceding PEL of 2
μg/m3\, and no cases of sensitization or CBD were observed among
workers with LTW exposure less than 0.02 μg/m3\. Twelve (60
percent) of the 20 sensitized workers had LTW exposures >0.20 μg/
m3\.
In 2007, Madl et al. published an additional study of 27 workers at
the machining plant who were found to be sensitized or diagnosed with
CBD between the start of medical surveillance in 1995 and 2005 (Madl et
al., 2007, Document ID 1056). As previously described, workers were
offered a BeLPT in the initial 1995 screening (or within 3 months of
their hire date if hired after 1995) and at 2-year intervals after
their first screening. Workers with two positive BeLPTs were identified
as sensitized and offered clinical evaluation for CBD, including
bronchoscopy with BAL and transbronchial lung biopsy. The criteria for
CBD in this study were somewhat stricter than those used in the Newman
et al. study, requiring evidence of granulomas on lung biopsy or
detection of X-ray or pulmonary function changes associated with CBD,
in combination with two positive BeLPTs or one positive BAL-BeLPT.
Based on the history of the plant's control efforts and their
analysis of historical IH data, Madl et al. identified three "exposure
control eras": A relatively uncontrolled period from 1980-1995; a
transitional period from 1996 to 1999; and a relatively well-controlled
"modern" period from 2000-2005. They found that the engineering and
work practice controls instituted in the mid-1990s reduced workers'
exposures substantially, with nearly a 15-fold difference in reported
exposure levels between the pre-control and the modern period (Madl et
al., 2007, Document ID 1056). Madl et al. estimated workers' exposures
using LP samples collected between 1980 and 2005, including those
collected by Kelleher et al., and work histories provided by the plant.
As described more fully in the study, they used a variety of approaches
to describe individual workers' exposures, including approaches
designed to characterize the highest exposures workers were likely to
have experienced. Their exposure-response analysis was based primarily
on an exposure metric they derived by identifying the year and job of
each worker's pre-diagnosis work history with the highest reported
exposures. They used the upper 95th percentile of the LP samples
collected in that job and year (in some cases supplemented with data
from other years) to characterize the worker's upper-level exposures.
Based on their estimates of workers' upper level exposures, Madl et
al. concluded that sensitized workers or workers with CBD were likely
to have been exposed to airborne beryllium levels greater than 0.2
μg/m3\ as an 8-hour TWA at some point in their history of
employment in the plant. Madl et al. also concluded that most
sensitization and CBD cases were likely to have been exposed to levels
greater than 0.4 μg/m3\
at some point in their work at the plant. Madl et al. did not
reconstruct exposures for workers at the plant who were not sensitized
and did not develop CBD and therefore could not determine whether non-
cases had upper-bound exposures lower than these levels. They found
that upper-bound exposure estimates were generally higher for workers
with CBD than for those who were sensitized but not diagnosed with CBD
at the conclusion of the study (Madl et al., 2007, Document ID 1056).
Because CBD is an immunological disease and beryllium sensitization has
been shown to occur within a year of exposure for some workers, Madl et
al. argued that their estimates of workers' short-term upper-bound
exposures may better capture the exposure levels that led to
sensitization and disease than estimates of long-term cumulative or
average exposures such as the LTW exposure measure constructed by
Kelleher et al. (Madl et al., 2007, Document ID 1056).
f. Beryllium Oxide Ceramics
Kreiss et al. (1993) conducted a screening of current and former
workers at a plant that manufactured beryllium ceramics from beryllium
oxide between 1958 and 1975, and then transitioned to metalizing
circuitry onto beryllium ceramics produced elsewhere (Document ID
1478). Of the plant's 1,316 current and 350 retired workers, 505
participated who had not previously been diagnosed with CBD or
sarcoidosis, including 377 current and 128 former workers. Although
beryllium exposure was not estimated quantitatively in this survey, the
authors conducted a questionnaire to assess study participants'
exposures qualitatively. Results showed that 55 percent of participants
reported working in jobs with exposure to beryllium dust. Close to 25
percent of participants did not know if they had exposure to beryllium,
and just over 20 percent believed they had not been exposed.
BeLPT tests were administered to all 505 participants in the 1989-
1990 screening period and evaluated at a single lab. Seven workers had
confirmed abnormal BeLPT results and were identified as sensitized;
these workers were also diagnosed with CBD based on findings of
granulomas upon clinical evaluation. Radiograph screening led to
clinical evaluation and diagnosis of two additional CBD cases, who were
among three participants with initially abnormal BeLPT results that
could not be confirmed on repeat testing. In addition, nine workers had
been previously diagnosed with CBD, and another five were diagnosed
shortly after the screening period, in 1991-1992.
Eight of the 9 CBD cases identified in the screening population
were hired before the plant stopped producing beryllium ceramics in
1975, and were among the 216 participants who had reported having been
near or exposed to beryllium dust. Particularly high CBD rates of 11.1
to 15.8 percent were found among screening participants who had worked
in process development/engineering, dry pressing, and ventilation
maintenance jobs believed to have high or uncontrolled dust exposure.
One case (0.6 percent) of CBD was diagnosed among the 171 study
participants who had been hired after the plant stopped producing
beryllium ceramics. Although this worker was hired eight years after
the end of ceramics production, he had worked in an area later found to
be contaminated with beryllium dust. The authors concluded that the
study results suggested an exposure-response relationship between
beryllium exposure and CBD, and recommended beryllium exposure control
to reduce workers' risk of CBD.
Kreiss et al. later published a study of workers at a second
ceramics plant located in Tucson, AZ (Kreiss et al., 1996, Document ID
1477), which since 1980 had produced beryllium ceramics from beryllium
oxide powder manufactured elsewhere. IH measurements collected between
1981 and 1992, primarily GA or short-term BZ samples and a few (<100)
LP samples, were available from the plant. Airborne beryllium exposures
were generally low. The majority of area samples were below the
analytical detection limit of 0.1 μg/m3\, while LP and short-term
BZ samples had medians of 0.3 μg/m3\. However, 3.6 percent of
short-term BZ samples and 0.7 percent of GA samples exceeded 5.0 μg/
m3\, while LP samples ranged from 0.1 to 1.8 μg/m3\. Machining
jobs had the highest beryllium exposure levels among job tasks, with
short-term BZ samples significantly higher for machining jobs than for
non-machining jobs (median 0.6 μg/m3\ vs. 0.3 μg/m3\, p =
0.0001). The authors used DWA formulas provided by the plant to
estimate workers' full-shift exposure levels, and to calculate
cumulative and average beryllium exposures for each worker in the
study. The median cumulative exposure was 591.7 mg-days/m3\ and the
median average exposure was 0.35 μg/m3\ as a DWA.
One hundred thirty-six of the 139 workers employed at the plant at
the time of the Kreiss et al. (1996) study underwent BeLPT screening
and chest radiographs in 1992 (Document ID 1477). Blood samples were
split between two laboratories. If one or both test results were
abnormal, an additional sample was collected and split between the
labs. Seven workers with an abnormal result on two draws were initially
identified as sensitized. Those with confirmed abnormal BeLPTs or
abnormal chest X-rays were offered clinical evaluation for CBD,
including transbronchial lung biopsy and BAL BeLPT. CBD was diagnosed
based on observation of granulomas on lung biopsy, in five of the six
sensitized workers who accepted evaluation. An eighth case of
sensitization and sixth case of CBD were diagnosed in one worker hired
in October 1991 whose initial BeLPT was normal, but who was confirmed
as sensitized and found to have lung granulomas less than two years
later, after sustaining a beryllium-contaminated skin wound. The plant
medical department reported 11 additional cases of CBD among former
workers (Kreiss et al., 1996, Document ID 1477). The overall prevalence
of sensitization in the plant was 5.9 percent, with a 4.4 percent
prevalence of CBD.
Kreiss et al. (1996) (Document ID 1477) reported that six (75
percent) of the eight sensitized workers were exposed as machinists
during or before the period October 1985-March 1988, when measurements
were first available for machining jobs. The authors reported that 14.3
percent of machinists were sensitized, compared to 1.2 percent of
workers who had never been machinists (p <0.01). Workers' estimated
cumulative and average beryllium exposures did not differ significantly
for machinists and non-machinists, or for cases and non-cases. As in
the previous study of the same ceramics plant published by Kreiss et
al. in 1993 (Document ID 1478), one case of CBD was diagnosed in a
worker who had never been employed in a production job. This worker was
employed in office administration, a job with a median DWA of 0.1
μg/m3\ (range 0.1-0.3 μg/m3\).
In 1998, Henneberger et al. conducted a follow-up cross-sectional
survey of 151 employees employed at the beryllium ceramics plant
studied by Kreiss et al. (1996) (Henneberger et al., 2001, Document ID
1313). All current plant employees were eligible for the study unless
they had previously been diagnosed with CBD. The study tracked two sets
of workers in presenting prevalence outcomes and exposure
characterization. "Short-term workers" were those hired since the
last plant survey in 1992. "Long-term workers"
were those hired before 1992 and had a longer history of beryllium
exposures. There were 74 short-term and 77 long-term workers in the
survey (Henneberger et al., 2001, Document ID 1313).
The authors estimated workers' cumulative, average, and peak
beryllium exposures based on the plant's formulas for estimating job-
specific DWA exposures, participants' work histories, and area and
short-term task-specific BZ samples collected from the start of full
production at the plant in 1981 to 1998. The long-term workers, who
were hired before the 1992 study was conducted, had generally higher
estimated exposures (median--0.39 μg/m3\; mean--14.9 μg/m3\)
than the short-term workers, who were hired after 1992 (median--0.28
μg/m3\, mean--6.1 μg/m3\).
Fifteen cases of sensitization were found in the 151 study
participants (15/151; 9.9%), including seven among short-term (7/74;
9.5%) and eight among long-term workers (8/77; 10.4%). There were eight
cases of CBD (8/151; 5.3%) identified in the study. One sensitized
short-term worker developed CBD (1/74; 1.4%). Seven of the eight
sensitized long-term workers developed CBD (7/77; 9.1%). The other
sensitized long-term worker declined to participate in the clinical
evaluation.
Henneberger et al. (2001) reported a higher prevalence of
sensitization among long-term workers with "high" (greater than
median) peak exposures compared to long-term workers with "low"
exposures; however, this relationship was not statistically significant
(Document ID 1313). No association was observed for average or
cumulative exposures. The authors reported higher (but not
statistically significant) prevalence of sensitization among short-term
workers with "high" (greater than median) average, cumulative, and
peak exposures compared to short-term workers with "low" exposures of
each type.
The cumulative incidence of sensitization and CBD was investigated
in a cohort of 136 workers at the beryllium ceramics plant previously
studied by the Kreiss and Henneberger groups (Schuler et al., 2008.
Document ID 1291). The study cohort consisted of those who participated
in the plant-wide BeLPT screening in 1992. Both current and former
workers from this group were invited to participate in follow-up BeLPT
screenings in 1998, 2000, and 2002-2003. A total of 106 of the 128 non-
sensitized individuals in 1992 participated in the 11-year follow-up.
Sensitization was defined as a confirmed abnormal BeLPT based on the
split blood sample-dual laboratory protocol described earlier. CBD was
diagnosed in sensitized individuals based on pathological findings from
transbronchial biopsy and BAL fluid analysis. The 11-year crude
cumulative incidence of sensitization and CBD was 13 percent (14 of
106) and 8 percent (9 of 106) respectively. The cumulative prevalence
was about triple the point prevalences determined in the initial 1992
cross-sectional survey. The corrected cumulative prevalences for those
that ever worked in machining were nearly twice that for non-
machinists. The data illustrate the value of longitudinal medical
screening over time to obtain a more accurate estimate of the
occurrence of sensitization and CBD among an exposed working
population.
Following the 1998 survey, the company continued efforts to reduce
exposures and risk of sensitization and CBD by implementing additional
engineering, administrative, and PPE measures (Cummings et al., 2007,
Document ID 1369). Respirator use was required in production areas
beginning in 1999, and latex gloves were required beginning in 2000.
The lapping area was enclosed in 2000, and enclosures were installed
for all mechanical presses in 2001. Between 2000 and 2003, water-
resistant or water-proof garments, shoe covers, and taped gloves were
incorporated to keep beryllium-containing fluids from wet machining
processes off the skin. The new engineering measures did not appear to
substantially reduce airborne beryllium levels in the plant. LP samples
collected between 2000 and 2003 had a median of 0.18 μg/m3\ in
production, similar to the 1994-1999 samples. However, respiratory
protection requirements to control workers' airborne beryllium
exposures were instituted prior to the 2000 sample collections, so
actual exposure to the production workers may have been lower than the
airborne beryllium levels indicate.
To test the efficacy of the new measures instituted after 1998, in
January 2000 the company began screening new workers for sensitization
at the time of hire and at 3, 6, 12, 24, and 48 months of employment.
These more stringent measures appear to have substantially reduced the
risk of sensitization among new employees. Of 126 workers hired between
2000 and 2004, 93 completed BeLPT testing at hire and at least one
additional test at 3 months of employment. One case of sensitization
was identified at 24 months of employment (1 percent of 126 workers).
This worker had experienced a rash after an incident of dermal exposure
to lapping fluid through a gap between his glove and uniform sleeve,
indicating that he may have become sensitized via the skin. He was
tested again at 48 months of employment, with an abnormal result.
A second worker in the 2000-2004 group had two abnormal BeLPT tests
at the time of hire, and a third had one abnormal test at hire and a
second abnormal test at 3 months. Both had normal BeLPTs at 6 months,
and were not tested thereafter. A fourth worker had one abnormal BeLPT
result at the time of hire, a normal result at 3 months, an abnormal
result at 6 months, and a normal result at 12 months. Four additional
workers had one abnormal result during surveillance, which could not be
confirmed upon repeat testing.
Cummings et al. (2007) calculated two sensitization rates based on
these screening results: (1) A rate using only the sensitized worker
identified at 24 months, and (2) a rate including all four workers who
had repeated abnormal results (Document ID 1369). They reported a
sensitization incidence rate (IR) of 0.7 per 1,000 person-months to 2.7
per 1,000 person-months for the workers hired between 2000 and 2004,
using the sum of sensitization-free months of employment among all 93
workers as the denominator.
The authors also estimated an incidence rate (IR) of 5.6 per 1,000
person-months for workers hired between 1993 and the 1998 survey. This
estimated IR was based on one BeLPT screening, rather than BeLPTs
conducted throughout the workers' employment. The denominator in this
case was the total months of employment until the 1998 screening.
Because sensitized workers may have been sensitized prior to the
screening, the denominator may overestimate sensitization-free time in
the legacy group, and the actual sensitization IR for legacy workers
may be somewhat higher than 5.6 per 1,000 person-months. Based on
comparison of the IRs, the authors concluded that the addition of
respirator use, dermal protection, and particle migration control
(housekeeping) improvements appeared to have reduced the risk of
sensitization among workers at the plant, even though airborne
beryllium levels in some areas of the plant had not changed
significantly since the 1998 survey.
g. Copper-Beryllium Alloy Processing and Distribution
Schuler et al. (2005) studied a group of 152 workers at a facility
who processed copper-beryllium alloys and small quantities of nickel-
beryllium alloys and converted semi-finished alloy
strip and wire into finished strip, wire, and rod. Production
activities included annealing, drawing, straightening, point and
chamfer, rod and wire packing, die grinding, pickling, slitting, and
degreasing. Periodically in the plant's history, it also performed salt
baths, cadmium plating, welding and deburring. Since the late 1980s,
rod and wire production processes have been physically segregated from
strip metal production. Production support jobs included mechanical
maintenance, quality assurance, shipping and receiving, inspection, and
wastewater treatment. Administration was divided into staff primarily
working within the plant and personnel who mostly worked in office
areas (Schuler, et al., 2005, Document ID 0919). Workers' respirator
use was limited, mostly to occasional tasks where high exposures were
anticipated.
Following the 1999 diagnosis of a worker with CBD, the company
surveyed the workforce, offering all current employees BeLPT testing in
2000 and offering sensitized workers clinical evaluation for CBD,
including BAL and transbronchial biopsy. Of the facility's 185
employees, 152 participated in the BeLPT screening. Samples were split
between two laboratories, with additional draws and testing for
confirmation if conflicting tests resulted in the initial draw. Ten
participants (7 percent) had at least two abnormal BeLPT results. The
results of nine workers who had abnormal BeLPT results from only one
laboratory were not included because the authors believed the
laboratory was experiencing technical problems with the test (Schuler
et al., 2005, Document ID 0919). CBD was diagnosed in six workers (4
percent) on evidence of pathogenic abnormalities (e.g., granulomas) or
evidence of clinical abnormalities consistent with CBD based on
pulmonary function testing, pulmonary exercise testing, and/or chest
radiography. One worker diagnosed with CBD had been exposed to
beryllium during previous work at another copper-beryllium processing
facility.
Schuler et al. (2005) evaluated airborne beryllium levels at the
plant using IH samples collected between 1969 and 2000, including 4,524
GA samples, 650 LP samples and 815 short-duration (3-5 min) high volume
(SD-HV) BZ task-specific samples (Document ID 0919). Occupational
exposures to airborne beryllium were generally low. Ninety-nine percent
of all LP measurements were below the preceding OSHA PEL of 2.0 μg/
m3\ (8-hr TWA); 93 percent were below the new final OSHA PEL of 0.2
μg/m3\ and the median value was 0.02 μg/m3\. The SD-HV BZ
samples had a median value of 0.44 μg/m3\, with 90 percent below
the preceding OSHA ceiling limit of 5.0 μg/m3\. The highest levels
of beryllium exposure were found in rod and wire production,
particularly in wire annealing and pickling, the only production job
with a median personal sample measurement greater than 0.1 μg/m3\
(median 0.12 μg/m3\; range 0.01-7.8 μg/m3\) (Schuler et al.,
Table 4). These concentrations were significantly higher than the
exposure levels in the strip metal area (median 0.02 μg/m3\, range
0.01-0.72 μg/m3\), in production support jobs (median 0.02 μg/
m3\, range <0.01-0.33 μg/m3\), plant administration (median 0.02
μg/m3\, range <0.01-0.11 μg/m3\), and office administration
jobs (median 0.01 μg/m3\, range <0.01-0.06 μg/m3\).
The authors reported that eight of the ten sensitized employees,
including all six CBD cases, had worked in both major production areas
during their tenure with the plant. The 7 percent prevalence (6 of 81
workers) of CBD among employees who had ever worked in rod and wire was
statistically significantly elevated compared with employees who had
never worked in rod and wire (p <0.05), while the 6 percent prevalence
(6 of 94 workers) among those who had worked in strip metal was not
significantly elevated compared to workers who had never worked in
strip metal (p > 0.1). Based on these results, together with the higher
exposure levels reported for the rod and wire production area, Schuler
et al. (2005) concluded that work in rod and wire was a key risk factor
for CBD in this population. Schuler et al. also found a high prevalence
(13 percent) of sensitization among workers who had been exposed to
beryllium for less than a year at the time of the screening, a rate
similar to that found by Henneberger et al. (2001) among beryllium
ceramics workers exposed for one year or less (16 percent) (Henneberger
et al., 2001, Document ID 1313). All four workers who were sensitized
without disease had been exposed for 5 years or less; conversely, all
six of the workers with CBD had first been exposed to beryllium at
least five years prior to the screening (Schuler et al., 2005, Table 2,
Document ID 0919).
As has been seen in other studies, beryllium sensitization and CBD
were found among workers who were typically exposed to low time-
weighted average airborne concentrations of beryllium. While jobs in
the rod and wire area had the highest exposure levels in the plant, the
median personal sample value was only 0.12 μg/m3\ as a DWA.
However, workers may have occasionally been exposed to higher beryllium
levels for short periods during specific tasks. A small fraction of
personal samples recorded in rod and wire were above the preceding OSHA
PEL of 2.0 μg/m3\, and half of workers with sensitization or CBD
reported that they had experienced a "high-exposure incident" at some
point in their work history (Schuler et al., 2005, Document ID 0919).
The only group of workers with no cases of sensitization or CBD, a
group of 26 office administration workers, was the group with the
lowest recorded exposures (median personal sample 0.01 μg/m3\,
range <0.01-0.06 μg/m3\).
After the BeLPT screening was conducted in 2000, the company began
implementing new measures to further reduce workers' exposure to
beryllium (Thomas et al., 2009, Document ID 1061). Measures designed to
minimize dermal contact with beryllium, including long-sleeve facility
uniforms and polymer gloves, were instituted in production areas in
2000. In 2001, the company installed LEV in die grinding and polishing.
LP samples collected between June 2000 and December 2001 show reduced
exposures plant-wide. Of 2,211 exposure samples collected, 98 percent
were below 0.2 μg/m3\, and 59 percent below the limit of detection
(LOD), which was either 0.02 µg/m3\ or 0.2 µg/m3\
depending on the method of sample analysis (Thomas et al., 2009).
Median values below 0.03 μg/m3\ were reported for all processes
except the wire annealing and pickling process. Samples for this
process remained somewhat elevated, with a median of 0.1 μg/m3\. In
January 2002, the plant enclosed the wire annealing and pickling
process in a restricted access zone (RAZ), requiring respiratory
protection in the RAZ and implementing stringent measures to minimize
the potential for skin contact and beryllium transfer out of the zone.
While exposure samples collected by the facility were sparse following
the enclosure, they suggest exposure levels comparable to the 2000-2001
samples in areas other than the RAZ. Within the RAZ, required use of
powered air-purifying respirators indicates that actual respiratory
exposure was negligible (Thomas et al., 2009, Document ID 1061).
To test the efficacy of the new measures in preventing
sensitization and CBD, in June 2000 the facility began an intensive
BeLPT screening program for all new workers. The company screened
workers at the time of hire; at intervals of 3, 6, 12, 24, and 48
months;
and at 3-year intervals thereafter. Among 82 workers hired after 1999,
three (3.7 percent) cases of sensitization were found. Two (5.4
percent) of 37 workers hired prior to enclosure of the wire annealing
and pickling process were found to be sensitized within 6 months of
beginning work at the plant. One (2.2 percent) of 45 workers hired
after the enclosure was confirmed as sensitized (Thomas et al., 2009,
Document ID 1061).
Thomas et al. (2009) calculated a sensitization IR of 1.9 per 1,000
person-months for the workers hired after the exposure control program
was initiated in 2000 ("program workers"), using the sum of
sensitization-free months of employment among all 82 workers as the
denominator (Thomas et al., 2009, Document ID 1061). They calculated an
estimated IR of 3.8 per 1,000 person-months for 43 workers hired
between 1993 and 2000 who had participated in the 2000 BeLPT screening
("legacy workers"). This estimated IR was based on one BeLPT
screening, rather than BeLPTs conducted throughout the legacy workers'
employment. The denominator in this case is the total months of
employment until the 2000 screening. Because sensitized workers may
have been sensitized prior to the screening, the denominator may
overestimate sensitization-free time in the legacy group, and the
actual sensitization IR for legacy workers may be somewhat higher than
3.8 per 1,000 person-months. Based on comparison of the IRs and the
prevalence rates discussed previously, the authors concluded that the
combination of dermal protection, respiratory protection, housekeeping
improvements and engineering controls implemented beginning in 2000
appeared to have reduced the risk of sensitization among workers at the
plant. However, they noted that the small size of the study population
and the short follow-up time for the program workers suggested that
further research is needed to confirm the program's efficacy (Thomas et
al., 2009, Document ID 1061).
Stanton et al. (2006) (Document ID 1070) conducted a study of
workers in three different copper-beryllium alloy distribution centers
in the United States. The distribution centers, consisting of one bulk
products center established in 1963 and strip metal centers established
in 1968 and 1972, sell products received from beryllium production and
finishing facilities and small quantities of copper-beryllium,
aluminum-beryllium, and nickel-beryllium alloy materials. Work at
distribution centers does not require large-scale heat treatment or
manipulation of material typical of beryllium processing and machining
plants, but involves final processing steps that can generate airborne
beryllium. Slitting, the main production activity at the two strip
product distribution centers, generates low levels of airborne
beryllium particles, while operations such as tensioning and welding
used more frequently at the bulk products center can generate somewhat
higher levels. Non-production jobs at all three centers included
shipping and receiving, palletizing and wrapping, production-area
administrative work, and office-area administrative work.
Stanton et al. (2006) estimated workers' beryllium exposures using
IH data from company records and job history information collected
through interviews conducted by a company occupational health nurse
(Document ID 1090). Stanton et al. evaluated airborne beryllium levels
in various jobs based on 393 full-shift LP samples collected from 1996
to 2004. Airborne beryllium levels at the plant were generally very
low, with 54 percent of all samples at or below the LOD, which ranged
from 0.02 to 0.1 μg/m3\. The authors reported a median of 0.03
μg/m3\ and an arithmetic mean of 0.05 μg/m3\ for the 393 full-
shift LP samples, where samples below the LOD were assigned a value of
half the applicable LOD. Median values for specific jobs ranged from
0.01-0.07 µg/m3\ while geometric mean values for specific jobs
ranged from 0.02-0.07 µg/m3\. All measurements were below the
preceding OSHA PEL of 2.0 μg/m3\ and 97 percent were below the new
final OSHA PEL of 0.2 μg/m3\. The study does not report use of
respiratory or skin protection.
Eighty-eight of the 100 workers (88 percent) employed at the three
centers at the time of the study participated in screening for
beryllium sensitization. Blood samples were collected between November
2000 and March 2001 by the company's medical staff. Samples collected
from employees of the strip metal centers were split and evaluated at
two laboratories, while samples from the bulk product center workers
were evaluated at a single laboratory. Participants were considered to
be "sensitized" to beryllium if two or more BeLPT results, from two
laboratories or from repeat testing at the same laboratory, were found
to be abnormal. One individual was found to be sensitized and was
offered clinical evaluation, including BAL and fiberoptic bronchoscopy.
He was found to have lung granulomas and was diagnosed with CBD.
The worker diagnosed with CBD had been employed at a strip metal
distribution center from 1978 to 2000 as a shipper and receiver,
loading and unloading trucks delivering materials from a beryllium
production facility and to the distribution center's customers.
Although the LP samples collected for his job between 1996 and 2000
were generally low (n = 35, median 0.01 µg/m3\, range <0.02-0.13
µg/m3\), it is not clear whether these samples adequately
characterize his exposure conditions over the course of his work
history. He reported that early in his work history, containers of
beryllium oxide powder were transported on the trucks he entered. While
he did not recall seeing any breaks or leaks in the beryllium oxide
containers, some containers were known to have been punctured by
forklifts on trailers used by the company during the period of his
employment, and could have contaminated trucks he entered. With 22
years of employment at the facility, this worker had begun beryllium-
related work earlier and performed it longer than about 90 percent of
the study population (Stanton et al., 2006, Document ID 1090).
h. Nuclear Weapons Production Facilities and Cleanup of Former
Facilities
Primary exposure from nuclear weapons production facilities comes
from beryllium metal and beryllium alloys. A study conducted by Kreiss
et al. (1989) (Document ID 1480) documented sensitization and CBD among
beryllium-exposed workers in the nuclear industry. A company medical
department identified 58 workers with beryllium exposure among a work
force of 500, of whom 51 (88 percent) participated in the study.
Twenty-four workers were involved in research and development (R&D),
while the remaining 27 were production workers. The R&D workers had a
longer tenure with a mean time from first exposure of 21.2 years,
compared to a mean time since first exposure of 5 years among the
production workers. Six workers had abnormal BeLPT readings, and four
were diagnosed with CBD. This study classified workers as sensitized
after one abnormal BeLPT reading, so this resulted in an estimated 11.8
percent prevalence of sensitization.
Kreiss et al. (1993) expanded the work of Kreiss et al. (1989)
(Document ID 1480) by performing a cross-sectional study of 895 current
and former beryllium workers in the same nuclear weapons plant
(Document ID 1479). Participants were placed in qualitative exposure
groups ("no exposure," "minimal exposure," "intermittent
exposure," and "consistent exposure") based on questionnaire
responses. Eighteen workers had abnormal BeLPT test results, with 12
being diagnosed with CBD. Three additional sensitized workers (those
with abnormal BeLPT results) developed CBD over the next 2 years.
Sensitization occurred in all of the qualitatively defined exposure
groups. Individuals who had worked as machinists were statistically
overrepresented among beryllium-sensitized cases, compared with non-
cases. Cases were more likely than non-cases to report having had a
measured overexposure to beryllium (p = 0.009), a factor which proved
to be a significant predictor of sensitization in logistic regression
analyses, as was exposure to beryllium prior to 1970. Beryllium
sensitized cases were also significantly more likely to report having
had cuts that were delayed in healing (p = 0.02). The authors concluded
that both individual susceptibility to sensitization and exposure
circumstance affect the development of beryllium sensitization and CBD.
In 1991, the Beryllium Health Surveillance Program (BHSP) was
established at the Rocky Flats Nuclear Weapons Facility to offer BeLPT
screening to current and former employees who may have been exposed to
beryllium (Stange et al., 1996, Document ID 0206). Participants
received an initial BeLPT and follow-ups at one and three years. Based
on histologic evidence of pulmonary granulomas and a positive BAL-
BeLPT, Stange et al. published a study of 4,397 BHSP participants
tested from June 1991 to March 1995, including current employees (42.8
percent) and former employees (57.2 percent). Twenty-nine cases of CBD
and 76 cases of sensitization were identified. The sensitization rate
for the population was 2.43 percent. Available exposure data included
fixed airhead exposure samples collected between 1970 and 1988 (mean
concentration 0.016 µg/m3\) and personal samples collected
between 1984 and 1987 (mean concentration 1.04 µg/m3\). Cases of
CBD and sensitization were noted in individuals in all jobs
classifications, including those believed to involve minimal exposure
to beryllium. The authors recommended ongoing surveillance for workers
in all jobs with potential for beryllium exposure.
Stange et al. (2001) extended the previous study, evaluating 5,173
participants in the Rocky Flats BHSP who were tested between June 1991
and December 1997 (Document ID 1403). Three-year serial testing was
offered to employees who had not been tested for three years or more
and did not show beryllium sensitization during the previous study.
This resulted in 2,891 employees being tested. Of the 5,173 workers
participating in the study, 172 were found to have abnormal BeLPT test
results. Ninety-eight (3.33 percent) of the workers were found to be
sensitized (confirmed abnormal BeLPT results) in the initial screening,
conducted in 1991. Of these workers 74 were diagnosed with CBD, based
on a history of beryllium exposure, evidence of non-caseating
granulomas or mononuclear cell infiltrates on lung biopsy, and a
positive BeLPT or BAL-BeLPT. A follow-up survey of 2,891 workers three
years later identified an additional 56 sensitized workers and an
additional seven cases of CBD. Sensitization and CBD rates were
analyzed with respect to gender, building work locations, and length of
employment. Historical employee data included hire date, termination
date, leave of absences, and job title changes. Exposure to beryllium
was determined by job categories and building or work area codes. In
order to determine beryllium exposure for all participants in the
study, personal beryllium air monitoring results were used, when
available, from employees with the same job title or similar job.
However, no quantitative exposure information was presented in the
study. The authors conclude that for some individuals, exposure to
beryllium at levels below the preceding OSHA PEL appears to cause
sensitization and CBD.
Viet et al. (2000) conducted a case-control study of the Rocky
Flats worker population studied by Stange et al. (1996 and 2001,
Document ID 0206 and 1403) to examine the relationship between
estimated beryllium exposure level and risk of sensitization or CBD.
The worker population included 74 beryllium-sensitized workers and 50
workers diagnosed with CBD. Beryllium exposure levels were estimated
based on fixed airhead samples from Building 444, the beryllium machine
shop, where machine operators were considered to have the highest
exposures at the Rocky Flats facility. These fixed air samples were
collected away from the breathing zone of the machine operator and
likely underestimated exposure. To estimate levels in other locations,
these air sample concentrations were used to construct a job exposure
matrix that included the determination of the Building 444 exposure
estimates for a 30-year period; each subject's work history by job
location, task, and time period; and assignment of exposure estimates
to each combination of job location, task, and time period as compared
to Building 444 machinists. The authors adjusted the levels observed in
the machine shop by factors based on interviews with former workers.
Workers' estimated mean exposure concentrations ranged from 0.083
µg/m3\ to 0.622 µg/m3\. Estimated maximum air
concentrations ranged from 0.54 µg/m3\ to 36.8 µg/m3\.
Cases were matched to controls of the same age, race, gender, and
smoking status (Viet et al., 2000, Document ID 1344).
Estimated mean and cumulative exposure levels and duration of
employment were found to be significantly higher for CBD cases than for
controls. Estimated mean exposure levels were significantly higher for
sensitization cases than for controls but no significant difference was
observed for estimated cumulative exposure or duration of exposure.
Similar results were found using logistic regression analysis, which
identified statistically significant relationships between CBD and both
cumulative and mean estimated exposure, but did not find significant
relationships between estimated exposure levels and sensitization
without CBD. Comparing CBD with sensitization cases, Viet et al. found
that workers with CBD had significantly higher estimated cumulative and
mean beryllium exposure levels than workers who were sensitized but did
not have CBD.
Johnson et al. (2001) conducted a review of personal sampling
records and medical surveillance reports at an atomic weapons
establishment in Cardiff, United Kingdom (Document ID 1505). The study
evaluated airborne samples collected over the 36-year period of
operation for the plant. Data included 367,757 area samples and 217,681
personal lapel samples from 194 workers from 1981-1997. The authors
estimated that over the 17 years of measurement data analyzed, airborne
beryllium concentrations did exceed 2.0 µg/m3\, but due to the
limitations with regard to collection times, it is difficult to assess
the full reliability of this estimate. The authors noted that in the
entire plant's history, only one case of CBD had been diagnosed. It was
also noted that BeLPT had not been routinely conducted among any of the
workers at this facility.
Arjomandi et al. (2010) (Document ID 1275) conducted a cross-
sectional study of workers at a nuclear weapons research and
development (R&D) facility to determine the risk of developing CBD in
sensitized workers at facilities with exposures much lower than
production plants (Document ID 1275). Of the 1,875 current or former
workers at the R&D facility, 59 were determined to be
sensitized based on at least two positive BeLPTs (i.e., samples drawn
on two separate occasions or on split samples tested in two separate
DOE-approved laboratories) for a sensitization rate of 3.1 percent.
Workers found to have positive BeLPTs were further evaluated in an
Occupational Medicine Clinic between 1999 and 2005. Arjomandi et al.
(2010) evaluated 50 of the sensitized workers who also had medical and
occupational histories, physical examination, chest imaging with high-
resolution computed tomography (HRCT) (N = 49), and pulmonary function
testing (nine of the 59 workers refused physical examinations so were
not included in this study). Forty of the 50 workers chosen for this
study underwent bronchoscopy for bronchoalveolar lavage and
transbronchial biopsies in additional to the other testing. Five of the
49 workers had CBD at the time of evaluation (based on histology or
high-resolution computed tomography); three others had evidence of
probable CBD; however, none of these cases were classified as severe at
the time of evaluation. The rate of CBD at the time of study among
sensitized individuals was 12.5 percent (5/40) for those using
pathologic review of lung tissue, and 10.2 percent (5/49) for those
using HRCT as a criteria for diagnosis. The rate of CBD among the
entire population (5/1875) was 0.3 percent.
The mean duration of employment at the facility was 18 years, and
the mean latency period (from first possible exposure) to time of
evaluation and diagnosis was 32 years. There was no available exposure
monitoring in the breathing zone of workers at the facility, but the
authors believed beryllium levels were relatively low (possibly less
than 0.1 μg/m3\ for most jobs). There was not an apparent exposure-
response relationship for sensitization or CBD. The sensitization
prevalence was similar across exposure categories and the CBD
prevalence higher among workers with the lower-exposure jobs. The
authors concluded that these sensitized workers, who were subjected to
an extended duration of low potential beryllium exposures over a long
latency period, had a low prevalence of CBD (Arjomandi et al., 2010,
Document ID 1275).
i. Aluminum Smelting
Bauxite ore, the primary source of aluminum, contains naturally
occurring beryllium. Worker exposure to beryllium can occur at aluminum
smelting facilities where aluminum extraction occurs via electrolytic
reduction of aluminum oxide into aluminum metal. Characterization of
beryllium exposures and sensitization prevalence rates were examined by
Taiwo et al. (2010) in a study of nine aluminum smelting facilities
from four different companies in the U.S., Canada, Italy, and Norway
(Document ID 0621).
Of the 3,185 workers determined to be potentially exposed to
beryllium, 1,932 (60 percent) agreed to participate in a medical
surveillance program between 2000 and 2006. The medical surveillance
program included BeLPT analysis, confirmation of an abnormal BeLPT with
a second BeLPT, and follow-up of all confirmed positive BeLPT results
by a pulmonary physician to evaluate for progression to CBD.
Eight-hour TWA exposures were assessed utilizing 1,345 personal
samples collected from the 9 smelters. The personal beryllium samples
obtained showed a range of 0.01-13.00 μg/m3\ TWA with an arithmetic
mean of 0.25 μg/m3\ and geometric mean of 0.06 μg/m3\. Based on
a survey of published studies, the investigators concluded that
exposure levels to beryllium observed in aluminum smelters were similar
to those seen in other industries that utilize beryllium. Of the 1,932
workers surveyed by BeLPT, nine workers were diagnosed with
sensitization (prevalence rate of 0.47 percent, 95% confidence interval
= 0.21-0.88 percent) with 2 of these workers diagnosed with probable
CBD after additional medical evaluations.
The authors concluded that compared with beryllium-exposed workers
in other industries, the rate of sensitization among aluminum smelter
workers appears lower. The authors speculated that this lower observed
rate could be related to a more soluble form of beryllium found in the
aluminum smelting work environment as well as the consistent use of
respiratory protection. However, the authors also speculated that the
low participation rate of 60 percent may have underestimated the
sensitization rate in this worker population.
A study by Nilsen et al. (2010) also found a low rate of
sensitization among aluminum workers in Norway. Three-hundred sixty-two
workers and thirty-one control individuals were tested for beryllium
sensitization based on the BeLPT. The results found that one (0.28%) of
the smelter workers had been sensitized. No borderline results were
reported. The exposures estimated in this plant were 0.1 µg/m3\
to 0.31 µg/m3\ (Nilsen et al., 2010, Document ID 0460).
6. Animal Models of CBD
This section reviews the relevant animal studies supporting the
biological mechanisms outlined above. In order for an animal model to
be useful for investigating the mechanisms underlying the development
of CBD, the model should include: The demonstration of a beryllium-
specific immune response; the formation of immune granulomas following
inhalation exposure to beryllium; and progression of disease as
observed in human disease. While exposure to beryllium has been shown
to cause chronic granulomatous inflammation of the lung in animal
studies using a variety of species, most of the granulomatous lesions
were not immune-induced reactions (which would predominantly consist of
T-cells or lymphocytes), but were foreign-body-induced reactions, which
predominantly consist of macrophages and monocytes, with only a small
numbers of lymphocytes. Although no single model has completely
mimicked the disease process as it progresses in humans, animal studies
have been useful in providing biological plausibility for the role of
immunological alterations and lung inflammation and in clarifying
certain specific mechanistic aspects of beryllium disease, such as
sensitization and CBD. However, there is no dependable animal model
that mimics all facets of the human response, and studies thus far have
been limited by single dose experiments, too few animals, or
abbreviated observation periods. Therefore, the utility of this data is
limited. The following is a discussion of the most relevant animal
studies regarding the mechanisms of sensitization and CBD development
in humans. Table A.2 in the Supplemental Information for the Beryllium
Health Effects Section summarizes species, route, chemical form of
beryllium, dose levels, and pathological findings of the key studies
(Document ID 1965).
Harmsen et al. performed a study to assess whether the beagle dog
could provide an adequate model for the study of beryllium-induced lung
diseases (Harmsen et al., 1986, Document ID 1257). One group of dogs
served as an air inhalation control group and four other groups
received high (approximately 50 μg/kg) and low (approximately 20
μg/kg) doses of beryllium oxide calcined at 500 [deg]C or 1,000
[deg]C, administered as aerosols in a single exposure.6
---------------------------------------------------------------------------
6 As discussed above, calcining temperature affects the
solubility and SSA of beryllium particles. Those particles calcined
at higher temperatures (e.g., 1,000 [deg]C) are less soluble and
have lower SSA than particles calcined at lower temperatures (e.g.,
500 [deg]C). Solubility and SSA are factors in determining the toxic
potential of beryllium compounds or materials.
---------------------------------------------------------------------------
BAL content was collected at 30, 60, 90, 180, and 210 days after
exposure, and lavage fluid and cellular content was evaluated for
neutrophilic and lymphocytic infiltration. In addition, BAL cells were
evaluated at the 210 day period to determine activation potential by
phytohemagglutinin (PHA) or beryllium sulfate as mitogen. BAL
neutrophils were significantly elevated only at 30 days with exposure
to either dose of 500 [deg]C beryllium oxide. BAL lymphocytes were
significantly elevated at all time points of the high dose of beryllium
oxide. No significant effect of 1,000 [deg]C beryllium oxide exposure
on mitogenic response of any lymphocytes was seen. In contrast,
peripheral blood lymphocytes from the 500 [deg]C beryllium oxide
exposed groups were significantly stimulated by beryllium sulfate
compared with the phytohemagglutinin exposed cells. Only the BAL
lymphocytes from animals exposed to the 500 [deg]C beryllium oxide
responded to stimulation by either PHA or beryllium sulfate.
In a series of studies, Haley et al. also found that the beagle dog
models certain aspects of human CBD (Haley et al., 1989, 1991 and 1992;
Document ID 1366, 1315, 1365. Briefly, dogs were exposed by inhalation
to a single exposure to beryllium aerosol generated from beryllium
oxide calcined at 500 [deg]C or 1,000 [deg]C for initial lung burdens
of 17 or 50 μg beryllium/kg body weight (Haley et al., 1989,
Document ID 1366; 1991 (1315)). The dogs were monitored for lung
pathologic effects, particle clearance, and immune sensitization of
peripheral blood leukocytes. Lung retention was higher in the 1,000
[deg]C treated beryllium oxide group (Haley et al., 1989, Document ID
1366).
Haley et al. (1989) described the bronchoalveolar lavage (BAL) and
histopathological changes in dogs exposed as described above. One group
of dogs underwent BAL for lung lymphocyte analysis at 3, 6, 7, 11, 15,
18, and 22 months post exposure. The investigators found an increase in
the percentage and numbers of lymphocytes in BAL fluid at 3 months
post-exposure in dogs exposed to either dose of beryllium oxide
calcined at 500 [deg]C and 1,000 [deg]C. Positive BeLPT results were
observed with BAL lymphocytes only in the group with a high initial
lung burden of the material calcined at 500 [deg]C at 3 and 6 month
post exposure. Another group underwent histopathological examination at
days 8, 32, 64, 180, and 365 (Haley et al., 1989, Document ID 1366;
1991 (1315)). Histopathologic examination revealed peribronchiolar and
perivascular lymphocytic histiocytic inflammation, peaking at 64 days
after beryllium oxide exposure. Lymphocytes were initially well
differentiated, but progressed to lymphoblastic cells and aggregated in
lymphofollicular nodules or microgranulomas over time. Although there
was considerable inter-animal variation, lesions were generally more
severe in the dogs exposed to material calcined at 500 [deg]C. The
investigators observed granulomatous lesions and lung lymphocyte
responses consistent with those observed in humans with CBD, including
perivascular and peribronchiolar infiltrates of lymphocytes and
macrophages, progressing to microgranulomas with areas of granulomatous
pneumonia and interstitial fibrosis. However, lesions declined in
severity after 64 days post-exposure. The lesions found in dog lungs
closely resembled those found in humans with CBD: Severe granulomas,
lymphoblast transformation, increased pulmonary lymphocyte
concentrations and variation in beryllium sensitivity. It was concluded
that the canine model for CBD may provide insight into this disease.
In a follow-up experiment, control dogs and those exposed to
beryllium oxide calcined at 500 [deg]C were allowed to rest for 2.5
years, and then re-exposed to filtered air (controls) or beryllium
oxide calcined at 500 [deg]C (cases) for an initial lung burden target
of 50 μg beryllium oxide/kg body weight (Haley et al., 1992,
Document ID 1365). Immune responses of blood and BAL lymphocytes, as
well as lung lesions in dogs sacrificed 210 days post-exposure, were
compared with results following the initial exposure. The severity of
lung lesions was comparable under both conditions, suggesting that a
2.5-year interval was sufficient to prevent cumulative pathologic
effects in beagle dogs.
In a comparison study of dogs and monkeys, Conradi et al. (1971)
exposed animals via inhalation to an average aerosol to either 0, 3,300
or 4,380 μg/m3\ of beryllium as beryllium oxide calcined at 1,400
[deg]C for 30 minutes, once per month for 3 months (Document ID 1319).
Conradi et al. found no changes in the histological or ultrastructure
of the lung of animals exposed to beryllium versus control animals.
This was in contrast to previous findings reported in other studies
cited by Conradi et al. The investigators speculated that the
differences may be due in part to calcination temperature or follow-up
time after initial exposure. The findings from Haley et al. (1989,
Document ID 1366; 1991 (1915); and 1992 (1365)) as well as Harmsen et
al. (1986, Document ID 1257) suggest that the beagle model for
sensitization of CBD is more closely related to the human response that
other species such as the monkey (and those reviewed in Table A2 of the
Supplemental Information for the Beryllium Health Effects Section).
A 1994 study by Haley et al. comparing the potential toxicity of
beryllium oxide versus beryllium metal showed that instillation of both
beryllium oxide and beryllium metal induced an immune response in
monkeys. Briefly, male cynomolgus monkeys were exposed to either
beryllium metal or beryllium oxide calcined at 500 [deg]C via
intrabronchiolar instillation as a saline suspension. Lymphocyte counts
in BAL fluid were observed through bronchoalveolar lavage at 14, 30,
60, 90, and 120 days post exposure, and were found to be significantly
increased in monkeys exposed to beryllium metal on post-exposure days
14, 30, 60, and 90, and in monkeys exposed to beryllium oxide on post-
exposure day 30 and 60. Histological examination of lung tissue
revealed that monkeys exposed to beryllium metal developed interstitial
fibrosis, Type II cell hyperplasia with increased lymphocytes
infiltration, and lymphocytic mantles accumulating around alveolar
macrophages. Similar but much less severe lesions were observed in
beryllium-oxide-exposed monkeys. Only monkeys exposed to beryllium
metal had positive BAL BeLPT results (Haley et al., 1994, Document ID
1364).
As discussed earlier in this Health Effects section, at the
cellular level, beryllium dissolution may be necessary in order for
either a dendritic cell or a macrophage to present beryllium as an
antigen to induce the cell-mediated CBD immune reactions (NAS, 2008,
Document ID 1355). Several studies have shown that low-fired beryllium
oxide, which is predominantly made up of poorly crystallized small
particles, is more immunologically reactive than beryllium oxide
calcined at higher firing temperatures that result in less reactivity
due to increasing crystal size (Stefaniak et al., 2006, Document ID
1398). As discussed previously, Haley et al. (1989, Document ID 1366)
found more severe lung lesions and a stronger immune response in beagle
dogs receiving a single inhalation exposure to beryllium oxide calcined
at 500 [deg]C than in dogs receiving an equivalent initial lung burden
of beryllium oxide calcined at 1,000 [deg]C. Haley et al. found that
beryllium oxide calcined at 1,000 [deg]C
elicited little local pulmonary immune response, whereas the much more
soluble beryllium oxide calcined at 500 [deg]C produced a beryllium-
specific, cell-mediated immune response in dogs (Haley et al., 1989,
Document ID 1366 and 1991 (1315)).
In a later study, beryllium metal appeared to induce a greater
toxic response than beryllium oxide following intrabronchiolar
instillation in cynomolgus monkeys, as evidenced by more severe lung
lesions, a larger effect on BAL lymphocyte counts, and a positive
response in the BeLPT with BAL lymphocytes only after exposure to
beryllium metal (Haley et al., 1994, Document ID 1364). A study by
Mueller and Adolphson (1979) observed that an oxide layer can develop
on beryllium-metal surfaces after exposure to air (Mueller and
Adolphson, 1979, Document ID 1260). According to the NAS report,
Harmesen et al (1994) suggested that the presence of beryllium metal
could lead to persistent exposures of small amounts beryllium oxide
sufficient for presentation to the immune system (NAS, 2008, Document
ID 1355).
Genetic studies in humans led to the creation of an animal model
containing different human HLA-DP alleles inserted into FVB/N mice for
mechanistic studies of CBD. Three strains of genetically engineered
mice (transgenic mice) were created that conferred different risks for
developing CBD based on human studies (Weston et al., 2005, Document ID
1345; Snyder et al., 2008 (0471)): (1) The HLA-DPB1*0401 transgenic
strain, where the transgene codes for lysine residue at the 69th
position of the B-chain conferred low risk of CBD; (2) the HLA-
DPB1*0201 mice, where the transgene codes for glutamic acid residue at
the 69th position of the B-chain conferred medium risk of CBD; and (3)
the HLA-DPB1*1701 mice, where the transgene codes for glutamic acid at
the 69th position of the B-chain but coded for a more negatively
charged protein to confer higher risk of CBD (Tarantino-Hutchinson et
al., 2009, Document ID 0536).
In order to validate the transgenic model, Tarantino-Hutchison et
al. challenged the transgenic mice along with seven different inbred
mouse strains to determine the susceptibility and sensitivity to
beryllium exposure. Mice were dermally exposed with either saline or
beryllium, then challenged with either saline or beryllium (as
beryllium sulfate) using the MEST protocol (mouse ear-swelling test).
The authors determined that the high risk HLA-DPB1*1701 transgenic
strain responded 4 times greater (as measured via ear swelling) than
control mice and at least 2 times greater than other strains of mice.
The findings correspond to epidemiological study results reporting an
enhanced CBD odds ratio for the HLA-DPB1*1701 in humans (Weston et al.,
2005, Document ID 1345; Snyder et al., 2008 (0471)). Transgenic mice
with the genes corresponding to the low and medium odds ratio study did
not respond significantly over the control group. The authors concluded
that while HLA-DPB1*1701 is important to beryllium sensitization and
progression to CBD, other genetic and environmental factors contribute
to the disease process as well.
7. Beryllium Sensitization and CBD Conclusions
There is substantial evidence that skin and inhalation exposure to
beryllium may lead to sensitization (section V.D.1) and that inhalation
exposure, or skin exposure coupled with inhalation exposure, may lead
to the onset and progression of CBD (section V.D.2). These conclusions
are supported by extensive human studies (section V.D.5). While all
facets of the biological mechanism for this complex disease have yet to
be fully elucidated, many of the key events in the disease sequence
have been identified and described in the earlier sections (sections
V.D.1-5). Sensitization is considered to be a necessary first step to
the onset of CBD (NAS, 2008, Document ID 1355; ERG, 2010 (1270)).
Sensitization is the process by which the immune system recognizes
beryllium as a foreign substance and responds in a manner that may lead
to development of CBD. It has been documented that a substantial
proportion of sensitized workers exposed to airborne beryllium can
progress to CBD (Rosenman et al., 2005, Document ID 1352; NAS, 2008
(1355); Mroz et al., 2009 (1356)). Animal studies, particularly in dogs
and monkeys, have provided supporting evidence for T cell lymphocyte
proliferation in the development of granulomatous lung lesions after
exposure to beryllium (Harmsen et al., 1986, Document ID 1257; Haley et
al., 1989 (1366), 1992 (1365), 1994 (1364)). The animal studies have
also provided important insights into the roles of chemical form,
genetic susceptibility, and residual lung burden in the development of
beryllium lung disease (Harmsen et al., 1986, Document ID 1257; Haley
et al., 1992 (1365); Tarantino-Hutchison et al., 2009 (0536)). The
evidence supports sensitization as an early functional change that
allows the immune system to recognize and adversely react to beryllium.
As such, OSHA regards beryllium sensitization as a necessary first step
along a continuum that can culminate in clinical lung disease.
The epidemiological evidence presented in section V.D.5
demonstrates that sensitization and CBD are continuing to occur from
exposures below OSHA's preceding PEL. The prevalence of sensitization
among beryllium-exposed workers, as measured by the BeLPT and reported
in 16 surveys of occupationally exposed cohorts reviewed by the Agency,
ranged from 0.3 to 14.5 percent (Deubner et al., 2001, Document ID
1543; Kreiss et al., 1997 (1360); Rosenman et al., 2005 (1352); Schuler
et al., 2012 (0473); Bailey et al., 2010 (0676); Newman et al., 2001
(1354); OSHA, 2014 (1589); Kreiss et al., 1996 (1477); Henneberger et
al., 2001 (0589); Cummings et al., 2007 (1369); Schuler et al., 2005
(0919); Thomas et al., 2009 (1061); Kreiss et al., 1989 (1480);
Arjomandi et al., 2010 (1275); Taiwo et al., 2011 (0621); Nilson et
al., 2010 (0460)). The lower prevalence estimates (0.3 to 3.7 percent)
were from facilities known to have implemented respiratory protection
programs and have lower personal exposures (Cummings et al., 2007,
Document ID 1369; Thomas et al., 2009 (1061); Bailey et al., 2010
(0676); Taiwo et al, 2011 (0621), Nilson et al., 2010 (0460); Arjomandi
et al., 2010 (1275)). Thirteen of the surveys also evaluated workers
for CBD and reported prevalences of CBD ranging from 0.1 to 7.8
percent. The cohort studies cover workers across many different
industries and processes as discussed in section V.D.5. Several studies
show that incidence of sensitization among workers can be reduced by
reducing inhalation exposure and that minimizing skin exposure may
serve to further reduce sensitization (Cummings et al., 2007, Document
ID 1369; Thomas et al., 2009 (1061); Bailey et al., 2010 (0676)). The
risk assessment further discusses the effectiveness of interventions to
reduce beryllium exposures and the risk of sensitization and CBD (see
section VI of this preamble, Risk Assessment).
Longitudinal studies of sensitized workers found early signs of
asymptomatic CBD that can progress to clinical disease in some
individuals. One study found that 31 percent of beryllium-exposed
sensitized employees progressed to CBD with an average follow-up time
of 3.8 years (Newman, 2005, Document ID 1437). However, Newman (2005)
went on to suggest that if follow-up times were much longer, the rate
of progression from
sensitization to CBD could be much higher. Mroz et al. (2009) (Document
ID 1356) conducted a longitudinal study between 1982 and 2002 in which
they followed 171 cases of CBD and 229 cases of sensitization initially
evaluated through workforce medical surveillance by National Jewish
Health. All study subjects had abnormal BeLPTs upon study entry and
were then clinically evaluated and treated for CBD. Over the 20-year
study period, 22 sensitized individuals went on to develop CBD which
was an incidence of 8.8 percent (i.e., 22 cases out of 251 sensitized,
calculated by adding those 22 cases to the 229 initially classified as
sensitized). The findings from this study indicated that the average
span of time from initial beryllium exposure to CBD diagnosis for those
22 workers was 24 years (Mroz et al., 2009, Document ID 1356).
A study of sensitized workers believed to have been exposed to low
levels of airborne beryllium metal (e.g., 0.01 µg/m3\ or less)
at a nuclear weapons research and development facility were clinically
evaluated between 1999 and 2005 (Arjomandi et al., 2010, Document ID
1275). Five of 49 sensitized workers (10.2 percent incidence) were
found to have pathology consistent with CBD. The CBD was asymptomatic
and had not progressed to clinical disease. The mean duration of
employment among workers in the study was 18 years with mean latency of
32 years to time of CBD diagnosis (Arjomandi et al., 2010, Document ID
1275). This suggests that some sensitized individuals can develop CBD
even from low levels of beryllium exposure. Another study of nuclear
weapons facility employees enrolled in an ongoing medical surveillance
program found that sensitization rate among exposed workers was highest
over the first 10 years of beryllium exposure while onset of CBD
pathology was greatest following 15 to 30 years of exposure (Stange et
al., 2001, Document ID 1403). This indicates length of exposure may
play a role in further development of the disease. OSHA concludes from
the study evidence that the persistent presence of beryllium in the
lungs of sensitized workers can lead to a progression of CBD over time
from an asymptomatic stage to serious clinical disease.
E. Beryllium Lung Cancer Section
Beryllium exposure is associated with a variety of adverse health
effects, including lung cancer. The potential for beryllium and its
compounds to cause cancer has been previously assessed by various other
agencies (EPA, ATSDR, NAS, NIEHS, and NIOSH), with each agency
identifying beryllium as a potential carcinogen. In addition, IARC did
an extensive evaluation in 1993 (Document ID 1342) and reevaluation in
April 2009 (IARC, 2012, Document ID 0650). In brief, IARC determined
beryllium and its compounds to be carcinogenic to humans (Group 1
category), while EPA considers beryllium to be a probable human
carcinogen (EPA, 1998, Document ID 0661), and the National Toxicology
Program (NTP) classifies beryllium and its compounds as known
carcinogens (NTP, 2014, Document ID 0389). OSHA has conducted an
independent evaluation of the carcinogenic potential of beryllium and
these compounds. The following is a summary of the studies used to
support the Agency's finding that beryllium and its compounds are human
carcinogens.
1. Genotoxicity Studies
Genotoxicity can be an important indicator for screening the
potential of a material to induce cancer and an important mechanism
leading to tumor formation and carcinogenesis. In a review conducted by
the National Academy of Science, beryllium and its compounds have
tested positively in nearly 50 percent of the genotoxicity studies
conducted without exogenous metabolic activity. However, they were
found to be non-genotoxic in most bacterial assays (NAS, 2008, Document
ID 1355).
Non-mammalian test systems (generally bacterial assays) are often
used to identify genotoxicity of a compound. In bacteria studies
evaluating beryllium sulfate for mutagenicity, all studies performed
utilizing the Ames assay (Simmon, 1979, Document ID 0434; Dunkel et
al., 1981 (0432); Arlauskas et al., 1985 (0454); Ashby et al., 1990
(0437)) and other bacterial assays (E. coli pol A (Rosenkranz and
Poirer, 1979, Document ID 1426); E. coli WP2 uvrA (Dunkel et al., 1981,
Document ID 0432), as well as those utilizing Saccharomyces cerevisiae
(Simmon, 1979, Document ID 0434)) were reported as negative, with the
exception of results reported for Bacillus subtilis rec assay (Kada et
al., 1980, Document ID 0433; Kanematsu et al., 1980 (1503)). Beryllium
nitrate was also reported as negative in the Ames assay (Tso and Fung,
1981, Document ID 0446; Kuroda et al., 1991 (1471)) but positive in a
Bacillus subtilis rec assay (Kuroda et al., 1991, Document ID 1471). In
addition, beryllium chloride was reported as negative using the Ames
assay (Ogawa et al., 1987, as cited in Document ID 1341, p. 112; Kuroda
et al., 1991 (1471)) and other bacterial assays (E. coli WP2 uvrA
(Rossman et al., 1984, Document ID 0431), as well as the Bacillus
subtilis rec assay (Nishioka, 1975, Document ID 0449)) and failed to
induce SOS DNA repair in E. coli (Rossman et al., 1984, Document ID
0431). Positive results for beryllium chloride were reported for
Bacillus subtilis rec assay using spores (Kuroda et al., 1991, Document
ID 1471) as well as increased mutations in the lacI gene of E. coli
KMBL 3835 (Zakour and Glickman, 1984, Document ID 1373). Beryllium
oxide was reported to be negative in the Ames assay and Bacillus
subtilis rec assays (Kuroda et al., 1991, Document ID 1471; EPA, 1998
(0661)).
Mutations using in vitro mammalian systems were also evaluated.
Beryllium chloride induced mutations in V79 and CHO cultured cells
(Miyaki et al., 1979, Document ID 0450; Hsie et al., 1978 (0427);
Vegni-Talluri and Guiggiani, 1967 (1382)), and beryllium sulfate
induced clastogenic alterations, producing breakage or disrupting
chromosomes in mammalian cells (Brooks et al., 1989, Document ID 0233;
Larramendy et al., 1981 (1468); Gordon and Bowser, 2003 (1520)).
However, beryllium sulfate did not induce unscheduled DNA synthesis in
primary rat hepatocytes and was not mutagenic when injected
intraperitoneally in adult mice in a host-mediated assay using
Salmonella typhimurium (Williams et al., 1982). Positive results were
found for beryllium chloride when evaluating the hprt gene in Chinese
hamster lung V79 cells (Miyaki et al., 1979, Document ID 0450).
Data from in vivo genotoxicity testing of beryllium are limited.
Beryllium metal was found to induce methylation of the p16 gene in the
lung tumors of rats exposed to beryllium metal (Swafford et al., 1997,
Document ID 1392) (described in more detail in section V.E.3). A study
by Nickell-Brady et al., (1994) found that beryllium sulfate (1.4 and
2.3 g/kg, 50 percent and 80 percent of median lethal dose) administered
by gavage did not induce micronuclei in the bone marrow of CBA mice.
However, a marked depression of red blood cell production was
suggestive of bone marrow toxicity, which was evident 24 hours after
dosing. No mutations were seen in p53 or c-raf-1 and only weak
mutations were detected in K-ras in lung carcinomas from F344/N rats
given a single nose-only exposure to beryllium metal (described in more
detail in section V. E. 3) (Nickell-Brady et al., 1994, Document ID
1312). On the other hand, beryllium chloride evaluated in a mouse model
indicated increased DNA strand breaks and the formation of micronuclei
in bone marrow (Attia et al., 2013, Document ID 0501).
In summary, genetic mutations have been observed in mammalian
systems (in vitro and in vivo) with beryllium chloride, beryllium
sulfate, and beryllium metal in a number of studies (Miyaki et al.,
1979, Document ID 0450; Hsie et al., 1978 (0427); Vegni-Talluri and
Guiggiani, 1967 (1382); Brooks et al., 1989 (0233); Larramendy et al.,
1981 (1468); Miyaki et al., 1979 (0450); Swafford et al., 1997 (1392);
Attia et al., 2013 (0501); EPA, 1998 (0661); Gordon and Bowser, 2003
(1520)). However, most studies utilizing non-mammalian test systems
(either with or without metabolic activity) have found that beryllium
chloride, beryllium nitrate, beryllium sulfate, and beryllium oxide did
not induce gene mutations, with the exception of Kada et al. (1980,
Document ID 0433) (Kanematsu et al.,1980, Document ID 1503; Kuroda et
al., 1991 (1471)).
2. Human Epidemiological Studies
This section describes the human epidemiological data supporting
the mechanistic overview of beryllium-induced lung cancer in workers.
It has been divided into reviews of epidemiological studies by industry
and beryllium form. The epidemiological studies utilizing data from the
BCR, in general, focus on workers mainly exposed to soluble forms of
beryllium. Those studies evaluating the epidemiological evidence by
industry or process are, in general, focused on exposures to poorly
soluble or mixed (soluble and poorly soluble) compounds. Table A.3 in
the Supplemental Information for the Beryllium Health Effects Section
summarizes the important features and characteristics of each study
discussed herein (Document ID 1965).
a. Beryllium Case Registry (BCR)
Two studies evaluated participants in the BCR (Infante et al.,
1980, Document ID 1507; Steenland and Ward, 1991 (1400)). Infante et
al. (1980) evaluated the mortality patterns of white male participants
in the BCR diagnosed with non-neoplastic respiratory symptoms of
beryllium disease. Of the 421 cases evaluated, 7 of the participants
had died of lung cancer. Six of the deaths occurred more than 15 years
after initial beryllium exposure. The duration of exposure for 5 of the
7 participants with lung cancer was less than 1 year, with the time
since initial exposure ranging from 12 to 29 years. One of the
participants was exposed for 4 years with a 26-year interval since the
initial exposure. Exposure duration for one participant diagnosed with
pulmonary fibrosis could not be determined; however, it had been 32
years since the initial exposure. Based on BCR records, the
participants were classified as being in the acute respiratory group
(i.e., those diagnosed with acute respiratory illness at the time of
entry in the registry) or the chronic respiratory group (i.e., those
diagnosed with pulmonary fibrosis or some other chronic lung condition
at the time of entry into the BCR). The 7 participants with lung cancer
were in the BCR because of diagnoses of acute respiratory illness. For
only one of those individuals was initial beryllium exposure less than
15 years prior. Only 1 of the 6 (with greater than 15 years since
initial exposure to beryllium) had been diagnosed with chronic
respiratory disease. The study did not report exposure concentrations
or smoking habits. The authors concluded that the results from this
cohort agreed with previous animal studies and with epidemiological
studies demonstrating an increased risk of lung cancer in workers
exposed to beryllium.
Steenland and Ward (1991) (Document ID 1400) extended the work of
Infante et al. (1980) (Document ID 1507) to include females and to
include 13 additional years of follow-up. At the time of entry in the
BCR, 93 percent of the women in the study, but only 50 percent of the
men, had been diagnosed with CBD. In addition, 61 percent of the women
had worked in the fluorescent tube industry and 50 percent of the men
had worked in the basic manufacturing industry with confirmed beryllium
exposure. A total of 22 males and 6 females died of lung cancer. Of the
28 total deaths from lung cancer, 17 had been exposed to beryllium for
less than 4 years and 11 had been exposed for greater than 4 years. The
study did not report exposure concentrations. Survey data collected in
1965 provided information on smoking habits for 223 cohort members (32
percent), on the basis of which the authors suggested that the rate of
smoking among workers in the cohort may have been lower than U.S.
rates. The authors concluded that there was evidence of increased risk
of lung cancer in workers exposed to beryllium and then diagnosed with
beryllium disease (ABD and CBD).
b. Beryllium Manufacturing and/or Processing Plants (Extraction,
Fabrication, and Processing)
Several epidemiological cohort studies have reported excess lung
cancer mortality among workers employed in U.S. beryllium production
and processing plants during the 1930s to 1960s.
Bayliss et al. (1971) (Document ID 1285) performed a nested cohort
study of 7,948 former workers from the beryllium processing industry
who were employed from 1942-1967. Information for the workers was
collected from the personnel files of participating companies. Of the
7,948 employees, a cause of death was known for 753 male workers. The
number of observed lung cancer deaths was 36 compared to 34.06 expected
for a standardized mortality ratio (SMR) of 1.06. When evaluated by the
number of years of employment, 24 of the 36 men were employed for less
than 1 year in the industry (SMR = 1.24), 8 were employed for 1 to 5
years (SMR 1.40), and 4 were employed for more than 5 years (SMR =
0.54). Half of the workers who died from lung cancer began employment
in the beryllium production industry prior to 1947. When grouped by job
classification, over two thirds of the workers with lung cancer were in
production-related jobs while the rest were classified as office
workers. The authors concluded that while the lung cancer mortality
rates were the highest of all other mortality rates, the SMR for lung
cancer was still within range of the expected based on death rates in
the United States. The limitations of this study included the lack of
information regarding exposure concentrations, smoking habits, and the
age and race of the participants.
Mancuso (1970, Document ID 1453; 1979, (0529); 1980 (1452)) and
Mancuso and El-Attar (1969) (Document ID 1455) performed a series of
occupational cohort studies on a group of workers (primarily white
males) employed in the beryllium manufacturing industry during 1937-
1948. The cohort identified in Mancuso and El-Attar (1969) was a study
of 3,685 workers (primarily white males) while Mancuso (1970, 1976,
1980) continued the study follow-up with 3266 workers due to several
limitations in identifying specific causes for mortality as identified
in Mancuso and El-Attar (1969). The beryllium production facilities
were located in Ohio and Pennsylvania and the records for the
employees, including periods of employment, were obtained from the
Social Security Administration. These studies did not include analyses
of mortality by job title or exposure category (exposure data was taken
from a study by Zielinsky et al., 1961 (as cited in Mancuso, 1970)). In
addition, there were no exposure concentrations estimated or
adjustments for smoking. The estimated duration of employment ranged
from less than 1 year to greater than 5 years. In the most recent study
(Mancuso, 1980), employees from the
viscose rayon industry served as a comparison population. There was a
significant excess of lung cancer deaths based on the total number of
80 observed lung cancer mortalities at the end of 1976 compared to an
expected number of 57.06 based on the comparison population resulting
in an SMR of 1.40 (p <0.01) (Mancuso, 1980). There was a statistically
significant excess in lung cancer deaths for the shortest duration of
employment (<12 months, p <0.05) and the longest duration of employment
(>49 months, p <0.01). Based on the results of this study, the author
concluded that the ability of beryllium to induce cancer in workers
does not require continuous exposure and that it is reasonable to
assume that the amount of exposure required to produce lung cancer can
occur within a few months of initial exposure regardless of the length
of employment.
Wagoner et al. (1980) (Document ID 1379) expanded the work of
Mancuso (1970, Document ID 1453; 1979 (0529); 1980 (1452)) using a
cohort of 3,055 white males from the beryllium extraction, processing,
and fabrication facility located in Reading, Pennsylvania. The men
included in the study worked at the facility sometime between 1942 and
1968, and were followed through 1976. The study accounted for length of
employment. Other factors accounted for included age, smoking history,
and regional lung cancer mortality. Forty-seven members of the cohort
died of lung cancer compared to an expected 34.29 based on U.S. white
male lung cancer mortality rates (p <.05). The results of this cohort
showed an excess risk of lung cancer in beryllium-exposed workers at
each duration of employment (<5 years and >=5 years), with a
statistically significant excess noted at <5 years of employment and a
>=25-year interval since the beginning of employment (p <0.05). The
study was criticized by two epidemiologists (MacMahon, 1978, Document
ID 0107; Roth, 1983 (0538)), by a CDC Review Committee appointed to
evaluate the study (as cited in Document ID 0067), and by one of the
study's coauthors (Bayliss, 1980, Document ID 0105) for inadequate
discussion of possible alternative explanations of excess lung cancer
in the cohort. The specific issues identified include the use of 1965-
1967 U.S. white male lung cancer mortality rates to generate expected
numbers of lung cancers in the period 1968-1975 (which may
underestimate the expected number of lung cancer deaths for the cohort)
and inadequate adjustment for smoking.
One occupational nested case-control study evaluated lung cancer
mortality in a cohort of 3,569 male workers employed at a beryllium
alloy production plant in Reading, PA, from 1940 to 1969 and followed
through 1992 (Sanderson et al., 2001, Document ID 1250). There were a
total of 142 known lung cancer cases and 710 controls. For each lung
cancer death, 5 age- and race-matched controls were selected by
incidence density sampling. Confounding effects of smoking were
evaluated. Job history and historical air measurements at the plant
were used to estimate job-specific beryllium exposures from the 1930s
to 1990s. Calendar-time-specific beryllium exposure estimates were made
for every job and used to estimate workers' cumulative, average, and
maximum exposures. Because of the long period of time required for the
onset of lung cancer, an "exposure lag" was employed to discount
recent exposures less likely to contribute to the disease.
The largest and most comprehensive study investigated the mortality
experience of 9,225 workers employed in 7 different beryllium
processing plants over a 30-year period (Ward et al., 1992, Document ID
1378). The workers at the two oldest facilities (i.e., Lorain, OH, and
Reading, PA) were found to have significant excess lung cancer
mortality relative to the U.S. population. The workers at these two
plants were believed to have the highest exposure levels to beryllium.
Ward et al. (1992) performed a retrospective mortality cohort study of
9,225 male workers employed at seven beryllium processing facilities,
including the Ohio and Pennsylvania facilities studied by Mancuso and
El-Attar (1969) (Document ID 1455), Mancuso (1970, Document ID 1453;
1979 (0529); 1980 (1452)), and Wagoner et al. (1980) (Document ID
1379). The men were employed for no less than 2 days between January
1940 and December 1969. Medical records were followed through 1988. At
the end of the study 61.1 percent of the cohort was known to be living
and 35.1 percent was known to be deceased. The duration of employment
ranged from 1 year or less to greater than 10 years with the largest
percentage of the cohort (49.7 percent) employed for less than one
year, followed by 1 to 5 years of employment (23.4 percent), greater
than 10 years (19.1 percent), and 5 to 10 years (7.9 percent). Of the
3,240 deaths, 280 observed deaths were caused by lung cancer compared
to 221.5 expected deaths, yielding a statistically significant SMR of
1.26 (p <0.01). Information on the smoking habits of 15.9 percent of
the cohort members, obtained from a 1968 Public Health Service survey
conducted at four of the plants, was used to calculate a smoking-
adjusted SMR of 1.12, which was not statistically significant. The
number of deaths from lung cancer was also examined by decade of hire.
The authors reported a relationship between earlier decades of hire and
increased lung cancer risk.
A different analysis of the lung cancer mortality in this cohort
using various local reference populations and alternate adjustments for
smoking generally found smaller, non-significant rates of excess
mortality among the beryllium-exposed employees (Levy et al., 2002,
Document ID 1463). Both cohort studies (Levy et al., 2002, Document ID
1463; Ward et al., 1992 (1378)) are limited by a lack of job history
and air monitoring data that would allow investigation of mortality
trends with different levels and durations of beryllium exposure. The
majority of employees at the Lorain, OH, and Reading, PA, facilities
were employed for a relatively short period of less than one year.
Levy et al. (2002) (Document ID 1463) questioned the results of
Ward et al. (1992) (Document ID 1378) and performed a reanalysis of the
Ward et al. data. The Levy et al. reanalysis differed from the Ward et
al. analysis in the following significant ways. First, Levy et al.
(2002) (Document ID 1463) examined two alternative adjustments for
smoking, which were based on (1) a different analysis of the American
Cancer Society (ACS) data used by Ward et al. (1992) (Document ID 1378)
for their smoking adjustment, or (2) results from a smoking/lung cancer
study of veterans. Second, Levy et al. (2002) also examined the impact
of computing different reference rates derived from information about
the lung cancer rates in the cities in which most of the workers at two
of the plants lived (Document ID 1463). Finally, Levy et al. (2002)
considered a meta-analytical approach to combining the results across
beryllium facilities (Document ID 1463). For all of the alternatives
Levy et al. (2002) (Document ID 1463) considered, except the meta-
analysis, the facility-specific and combined SMRs derived were lower
than those reported by Ward et al. (1992) (Document ID 1378). Only the
SMR for the Lorain, OH, facility remained statistically significantly
elevated in some reanalyses. The SMR obtained when combining over the
plants was not statistically significant in eight of the nine
approaches they examined, leading
Levy et al. (2002) (Document ID 1463) to conclude that there was little
evidence of statistically significant elevated SMRs in those plants.
This study was not included in the synthesis of epidemiological studies
assessed by IARC due to several methodological limitations (IARC, 2012,
Document ID 0650).
The EPA Integrated Risk Information System (IRIS), IARC, and
California EPA Office of Environmental Health Hazard Assessment (OEHHA)
all based their cancer assessments on the Ward et al. 1992 study, with
supporting data concerning exposure concentrations from Eisenbud and
Lisson (1983) (Document ID 1296) and NIOSH (1972) (Document ID 0560),
who estimated that the lower-bound estimate of the median exposure
concentration exceeded 100 µg/m3\ and found that concentrations
in excess of 1,000 µg/m3\ were common. The IRIS cancer risk
assessment recalculated expected lung cancers based on U.S. white male
lung cancer rates (including the period 1968-1975) and used an
alternative adjustment for smoking. In addition, one individual with
lung cancer, who had not worked at the plant, was removed from the
cohort. After these adjustments were made, an elevated rate of lung
cancer was still observed in the overall cohort (46 cases vs. 41.9
expected cases). However, based on duration of employment or interval
since beginning of employment, neither the total cohort nor any of the
subgroups had a statistically significant increase in lung cancer
deaths (EPA, 1987, Document ID 1295). Based on its evaluation of this
and other epidemiological studies, the EPA characterized the human
carcinogenicity data then available as "limited" but "suggestive of
a causal relationship between beryllium exposure and an increased risk
of lung cancer" (EPA, 1998, Document ID 0237). The EPA report includes
quantitative estimates of risk that were derived using the information
presented in Wagoner et al. (1980), the expected lung cancers
recalculated by the EPA, and bounds on presumed exposure levels.
Sanderson et al. (2001) (Document ID 1419) estimated the
cumulative, average, and maximum beryllium exposure concentration for
the 142 known lung cancer cases to be 46.06 9.3µg/
m3\-days, 22.8 3.4 µg/m3\, and 32.4
13.8 µg/m3\, respectively. The lung cancer mortality rate was
1.22 (95 percent CI = 1.03 - 1.43). Exposure estimates were lagged by
10 and 20 years in order to account for exposures that did not
contribute to lung cancer because they occurred after the induction of
cancer. In the 10- and 20-year lagged exposures the geometric mean
tenures and cumulative exposures of the lung cancer mortality cases
were higher than the controls. In addition, the geometric mean and
maximum exposures of the workers were significantly higher than
controls when the exposure estimates were lagged 10 and 20 years (p
<0.01).
Results of a conditional logistic regression analysis indicated
that there was an increased risk of lung cancer in workers with higher
exposures when dose estimates were lagged by 10 and 20 years (Sanderson
et al., 2001, Document ID 1419). There was also a lack of evidence that
confounding factors such as smoking affected the results of the
regression analysis. The authors noted that there was considerable
uncertainty in the estimation of exposure in the 1940s and 1950s and
the shape of the dose-response curve for lung cancer (Sanderson et al.,
2001, Document ID 1419). Another analysis of the study data using a
different statistical method did not find a significantly greater
relative risk of lung cancer with increasing beryllium exposures (Levy
et al., 2007). The average beryllium air levels for the lung cancer
cases were estimated to be an order of magnitude above the preceding 8-
hour OSHA TWA PEL (2 μg/m3\) and roughly two orders of magnitude
higher than the typical air levels in workplaces where beryllium
sensitization and pathological evidence of CBD have been observed. IARC
evaluated this reanalysis in 2012 and found the study introduced a
downward bias into risk estimates (IARC, 2012, Document ID 0650). NIOSH
comments in the rulemaking docket support IARC's finding (citing
Schubauer-Berigan et al., 2007; Hein et al., 2009, 2011; Langholz and
Richardson 2009; Wacholder 2009) (Document ID 1671, Attachment 1, p.
10).
Schubauer-Berigan et al. (2008) (Document ID 1350) reanalyzed data
from the Sanderson et al. (2001) nested case-control study of 142 lung
cancer cases in the Reading, PA, beryllium processing plant. This
dataset was reanalyzed using conditional (stratified by case age)
logistic regression. Independent adjustments were made for potential
confounders of birth year and hire age. Average and cumulative
exposures were analyzed using the values reported in the original
study. The objective of the reanalysis was to correct for the known
differences in smoking rates by birth year. In addition, the authors
evaluated the effects of age at hire to determine differences observed
by Sanderson et al. in 2001 (Document ID 1419). The effect of birth
cohort adjustment on lung cancer rates in beryllium-exposed workers was
evaluated by adjusting in a multivariable model for indicator variables
for the birth cohort quartiles.
Unadjusted analyses showed little evidence of lung cancer risk
associated with beryllium occupational exposure using cumulative
exposure until a 20-year lag was used. Adjusting for either birth
cohort or hire age attenuated the risk for lung cancer associated with
cumulative exposure. Using a 10- or 20-year lag in workers born after
1900 also showed little evidence of lung cancer risk, while those born
prior to 1900 did show a slight elevation in risk. Unlagged and lagged
analysis for average exposure showed an increase in lung cancer risk
associated with occupational exposure to beryllium. The finding was
consistent for either workers adjusted or unadjusted for birth cohort
or hire age. Using a 10-year lag for average exposure showed a
significant effect by birth cohort.
Schubauer-Berigan et al. stated that the reanalysis indicated that
differences in the hire ages among cases and controls, first noted by
Deubner et al. (2001) (Document ID 0109) and Levy et al. (2007)
(Document ID 1462), were primarily due to the fact that birth years
were earlier among controls than among cases, resulting from much lower
baseline risk of lung cancer for men born prior to 1900 (Schubauer-
Berigan et al., 2008, Document ID 1350). The authors went on to state
that the reanalysis of the previous NIOSH case-control study suggested
the relationship observed previously between cumulative beryllium
exposure and lung cancer was greatly attenuated by birth cohort
adjustment.
Hollins et al. (2009) (Document ID 1512) re-examined the weight of
evidence of beryllium as a lung carcinogen in a recent publication.
Citing more than 50 relevant papers, the authors noted the
methodological shortcomings examined above, including lack of well-
characterized historical occupational exposures and inadequacy of the
availability of smoking history for workers. They concluded that the
increase in potential risk of lung cancer was observed among those
exposed to very high levels of beryllium and that beryllium's
carcinogenic potential in humans at these very high exposure levels was
not relevant to today's industrial settings. IARC performed a similar
re-evaluation in 2009 (IARC, 2012, Document ID 0650) and found that the
weight of evidence for beryllium lung carcinogenicity, including the
animal studies described below, still warranted a Group I
classification, and that
beryllium should be considered carcinogenic to humans.
Schubauer-Berigan et al. (2011) (Document ID 1266) extended their
analysis from a previous study estimating associations between
mortality risk and beryllium exposure to include workers at 7 beryllium
processing plants. The study followed the mortality incidences of 9,199
workers from 1940 through 2005 at the 7 beryllium plants. JEMs were
developed for three plants in the cohort: The Reading plant, the
Hazleton plant, and the Elmore plant. The last is described in Couch et
al. 2010. Including these JEMs substantially improved the evidence base
for evaluating the carcinogenicity of beryllium, and this change
represents more than an update of the beryllium cohort. Standardized
mortality ratios (SMRs) were estimated based on U.S. population
comparisons for lung, nervous system and urinary tract cancers, chronic
obstructive pulmonary disease (COPD), chronic kidney disease, and
categories containing chronic beryllium disease (CBD) and cor
pulmonale. Associations with maximum and cumulative exposure were
calculated for a subset of the workers.
Overall mortality in the cohort compared with the U.S. population
was elevated for lung cancer (SMR 1.17; 95% CI 1.08 to 1.28), COPD (SMR
1.23; 95% CI 1.13 to 1.32), and the categories containing CBD (SMR
7.80; 95% CI 6.26 to 9.60) and cor pulmonale (SMR 1.17; 95% CI 1.08 to
1.26) (Schubauer-Berigan et al., 2011, Document ID 1266). Mortality
rates for most diseases of interest increased with time since hire. For
the category including CBD, rates were substantially elevated compared
to the U.S. population across all exposure groups. Workers whose
maximum beryllium exposure was >=10 μg/m3\ had higher rates of lung
cancer, urinary tract cancer, COPD and the category containing cor
pulmonale than workers with lower exposure. These studies showed strong
associations for cumulative exposure (when short-term workers were
excluded), maximum exposure, or both. Significant positive trends with
cumulative exposure were observed for nervous system cancers (p =
0.0006) and, when short-term workers were excluded, lung cancer (p =
0.01), urinary tract cancer (p = 0.003), and COPD (p <0.0001).
The authors concluded that the findings from this reanalysis
reaffirmed that lung cancer and CBD are related to beryllium exposure.
The authors went on to suggest that beryllium exposures may be
associated with nervous system and urinary tract cancers and that
cigarette smoking and other lung carcinogens were unlikely to explain
the increased incidences in these cancers. The study corrected an error
that was discovered in the indirect smoking adjustment initially
conducted by Ward et al., concluding that cigarette smoking rates did
not differ between the cohort and the general U.S. population. No
association was found between cigarette smoking and either cumulative
or maximum beryllium exposure, making it very unlikely that smoking was
a substantial confounder in this study (Schubauer-Berigan et al., 2011,
Document ID 1266).
A study by Boffetta et al. (2014, Document ID 0403) and an abstract
by Boffetta et al., (2015, Document ID 1661, Attachment 1) were
submitted by Materion for Agency consideration (Document ID 1661, p.
3). Briefly, Boffetta et al. investigated lung cancer and other
diseases in a cohort of 4,950 workers in four beryllium manufacturing
facilities. Based on available process information from the facilities,
the cohort of workers included only those working with poorly soluble
beryllium. Workers having potential for soluble beryllium exposure were
excluded from the study. Boffetta et al. reported a slight increase in
lung cancer rates among workers hired prior to 1960, but the increase
was reported as not statistically significant. Bofetta et al. (2014)
indicated that "[t]his study confirmed the lack of an increase in
mortality from lung cancer and nonmalignant respiratory diseases
related to [poorly] soluble beryllium compounds" (Document ID 0403, p.
587). OSHA disagrees, and a more detailed analysis of the Boffetta et
al. (2014, Document ID 0403) study is provided in the Risk Assessment
section (VI) of this preamble. The Boffetta et al. (2015, Document ID
1661, Attachment 1) study cited by Materion was an abstract to the 48th
annual Society of Epidemiological Research conference and does not
provide sufficient information for OSHA to consider.
To summarize, most of the epidemiological studies reviewed in this
section show an elevated lung cancer rate in beryllium-exposed workers
compared to control groups. While exposure data was incomplete in many
studies inferences can be made based on industry profiles.
Specifically, studies reviewing excess lung cancer in workers
registered in the BCR found an elevated lung cancer rate in those
patients identified as having acute beryllium disease (ABD). ABD
patients are most closely associated with exposure to soluble forms of
beryllium (Infante et al., 1980, Document ID 1507; Steenland and Ward,
1991 (1348)). Industry profiles in processing and extraction indicate
that most exposures would be due to poorly soluble forms of beryllium.
Excess lung cancer rates were observed in workers in industries
associated with extraction and processing (Schubauer-Berigan et al.,
2008, Document ID 1350; Schubauer-Berigan et al. 2011 (1266, 1815
Attachment 105); Ward et al., 1992 (1378); Hollins et al., 2009 (1512);
Sanderson et al., 2001 (1419); Mancuso et al., 1980 (1452); Wagoner et
al., 1980 (1379)). During the public comment period NIOSH noted that:
. . . in Table 1 of Ward et al. (1992), all three of these beryllium
plants were engaged in operations associated with both soluble and
[poorly soluble] forms of beryllium. Industrial hygienists from
NIOSH [Sanderson et al. (2001); Couch et al. (2011)] and elsewhere
[Chen (2001); Rosenman et al. (2005)] created job-exposure matrices
(JEMs), which estimated the form of beryllium exposure (soluble,
consisting of beryllium salts; [poorly soluble], consisting of
beryllium metal, alloys, or beryllium oxide; and mixed forms)
associated with each job, department and year combination at each
plant. Unpublished evaluations of these JEM estimates linked to the
employee work histories in the NIOSH risk assessment study
[Schubauer-Berigan et al., 2011b, Document ID 0521] show that the
vast majority of beryllium work-time at all three of these
facilities was due to either [poorly] soluble or mixed chemical
forms. In fact, [poorly] soluble beryllium was the largest single
contributor to work-time (for beryllium exposure of known solubility
class) at the three facilities across most time periods . . . .
Therefore, the strong and consistent exposure-response pattern that
was observed in the published NIOSH studies was very likely
associated with exposure to [poorly] soluble as well as soluble
forms of beryllium. (Document ID 1725, p. 9)
Taken collectively, the Agency finds that the epidemiological data
presented in the reviewed studies provides sufficient evidence to
demonstrate carcinogenicity in humans of both soluble and poorly
soluble forms of beryllium.
3. Animal Cancer Studies
This section reviews the animal literature used to support the
findings for beryllium-induced lung cancer. Early animal studies
revealed that some beryllium compounds are carcinogenic when inhaled
(ATSDR, 2002, Document ID 1371). Lung tumors have been induced via
inhalation and intratracheal administration of beryllium to rats and
monkeys, and osteosarcomas have been induced via intravenous and
intramedullary (inside the bone) injection of beryllium in rabbits and
mice. In addition to lung cancer,
osteosarcomas have been produced in mice and rabbits exposed to various
beryllium salts by intravenous injection or implantation into the bone
(NTP, 1999, Document ID 1341: IARC, 2012 (0650)). While not completely
understood, experimental studies in animals (in vitro and in vivo) have
found that a number of mechanisms are likely involved in beryllium-
induced carcinogenicity, including chronic inflammation, genotoxicity,
mitogenicity, oxidative stress, and epigenetic changes.
In an inhalation study assessing the potential tumorigenicity of
beryllium, Schepers et al. (1957) (Document ID 0458) exposed 115 albino
Sherman and Wistar rats (male and female) via inhalation to 0.0357 mg
beryllium/m3\ (1 [gamma] beryllium/ft3) 7 as an aqueous aerosol of
beryllium sulfate for 44 hours/week for 6 months, and observed the rats
for 18 months after exposure. Three to four control rats were killed
every two months for comparison purposes. Seventy-six lung
neoplasms,8 including adenomas, squamous-cell carcinomas, acinous
adenocarcinomas, papillary adenocarcinomas, and alveolar-cell
adenocarcinomas, were observed in 52 of the rats exposed to the
beryllium sulfate aerosol. Adenocarcinomas were the most numerous.
Pulmonary metastases tended to localize in areas with foam cell
clustering and granulomatosis. No neoplasia was observed in any of the
control rats. The incidence of lung tumors in exposed rats is presented
in the following Table 3:
---------------------------------------------------------------------------
7 Schepers et al. (1957) reported concentrations in [gamma]
Be/ft3; however, [gamma]/ft3 is no longer a common unit.
Therefore, the concentration was converted to mg/m3\.
8 While a total of 89 tumors were observed or palpated at the
time of autopsy in the BeSO4-exposed animals, only 76
tumors are listed as histologically neoplastic. Only the new growths
identified in single midcoronal sections of both lungs were
recorded.
Table 3--Neoplasm Analysis, Based on Schepers et al. (1957)
------------------------------------------------------------------------
Neoplasm Number Metastases
------------------------------------------------------------------------
Adenoma........................................ 18 0
Squamous carcinoma............................. 5 1
Acinous adenocarcinoma......................... 24 2
Papillary adenocarcinoma....................... 11 1
Alveolar-cell adenocarcinoma................... 7 0
Mucigenous tumor............................... 7 1
Endothelioma................................... 1 0
Retesarcoma.................................... 3 3
------------------------
Total...................................... 76 8
------------------------------------------------------------------------
Schepers (1962) (Document ID 1414) reviewed 38 existing beryllium
studies that evaluated seven beryllium compounds and seven mammalian
species. Beryllium sulfate, beryllium fluoride, beryllium phosphate,
beryllium alloy (BeZnMnSiO4), and beryllium oxide were
proven to be carcinogenic. Ten varieties of tumors were observed, with
adenocarcinoma being the most common variety.
In another study, Vorwald and Reeves (1959) (Document ID 1482)
exposed Sherman albino rats via the inhalation route to aerosols of
0.006 mg beryllium/m3\ as beryllium oxide and 0.0547 mg beryllium/m3\
as beryllium sulfate for 6 hours/day, 5 days/week for an unspecified
duration. Lung tumors (single or multifocal) were observed in the
animals sacrificed following 9 months of daily inhalation exposure. The
histologic pattern of the cancer was primarily adenomatous; however,
epidermoid and squamous cell cancers were also observed. Infiltrative,
vascular, and lymphogenous extensions often developed with secondary
metastatic growth in the tracheobronchial lymph nodes, the mediastinal
connective tissue, the parietal pleura, and the diaphragm.
In the first of two articles, Reeves et al. (1967) investigated the
carcinogenic process in lungs resulting from chronic (up to 72 weeks)
beryllium sulfate inhalation (Document ID 1310). One hundred fifty male
and female Sprague Dawley C.D. strain rats were exposed to beryllium
sulfate aerosol at a mean atmospheric concentration of 34.25 μg
beryllium/m3\ (with an average particle diameter of 0.12 µm).
Prior to initial exposure and again during the 67-68 and 75-76 weeks of
life, the animals received prophylactic treatments of tetracycline-HCl
to combat recurrent pulmonary infections.
The animals entered the exposure chamber at 6 weeks of age and were
exposed 7 hours per day/5 days per week for up to 2,400 hours of total
exposure time. An equal number of unexposed controls were held in a
separate chamber. Three male and three female rats were sacrificed
monthly during the 72-week exposure period. Mortality due to
respiratory or other infections did not appear until 55 weeks of age,
and 87 percent of all animals survived until their scheduled
sacrifices.
Average lung weight towards the end of exposure was 4.25 times
normal with progressively increasing differences between control and
exposed animals. The increase in lung weight was accompanied by notable
changes in tissue texture with two distinct pathological processes--
inflammatory and proliferative. The inflammatory response was
characterized by marked accumulation of histiocytic elements forming
clusters of macrophages in the alveolar spaces. The proliferative
response progressed from early epithelial hyperplasia of the alveolar
surfaces, through metaplasia (after 20-22 weeks of exposure), anaplasia
(cellular dedifferentiation) (after 32-40 weeks of exposure), and
finally to lung tumors.
Although the initial proliferative response occurred early in the
exposure period, tumor development required considerable time. Tumors
were first identified after nine months of beryllium sulfate exposure,
with rapidly increasing rates of incidence until tumors were observed
in 100 percent of exposed animals by 13 months. The 9-to-13-month
interval is consistent with earlier studies. The tumors showed a high
degree of local invasiveness. No tumors were observed in control rats.
All 56 tumors studied appeared to be alveolar adenocarcinomas and 3
were "fast-growing" tumors that reached a very large size
comparatively early. About one-third of the tumors showed small foci
where the histologic pattern differed. Most of the early tumor foci
appeared to be alveolar rather than bronchiolar, which is consistent
with the expected pathogenesis, since permanent deposition of beryllium
was more likely on the alveolar epithelium rather than on the
bronchiolar epithelium. Female rats appeared to have an increased
susceptibility to beryllium exposure. Not only did they have a higher
mortality (control males [n = 8], exposed males [n = 9] versus control
females [n = 4], exposed females [n = 17]) and body weight loss than
male rats, but the three "fast-growing" tumors occurred in females.
In the second article, Reeves et al. (1967) (Document ID 1309)
described the rate of accumulation and clearance of beryllium sulfate
aerosol from the same experiment (Reeves et al., 1967) (Document ID
1310). At the time of the monthly sacrifice, beryllium assays were
performed on the lungs, tracheobronchial lymph nodes, and blood of the
exposed rats. The pulmonary beryllium levels of rats showed a rate of
accumulation which
decreased during continuing exposure and reached a plateau (defined as
equilibrium between deposition and clearance) of about 13.5 μg
beryllium for males and 9 μg beryllium for females in whole lungs
after approximately 36 weeks. Females were notably less efficient than
males in utilizing the lymphatic route as a method of clearance,
resulting in slower removal of pulmonary beryllium deposits, lower
accumulation of the inhaled material in the tracheobronchial lymph
nodes, and higher morbidity and mortality.
There was no apparent correlation between the extent and severity
of pulmonary pathology and total lung load. However, when the beryllium
content of the excised tumors was compared with that of surrounding
nonmalignant pulmonary tissues, the former showed a notable decrease
(0.50 0.35 μg beryllium/gram versus 1.50
0.55 μg beryllium/gram). This was believed to be largely a result of
the dilution factor operating in the rapidly growing tumor tissue.
However, other factors, such as lack of continued local deposition due
to impaired respiratory function and enhanced clearance due to high
vascularity of the tumor, may also have played a role. The portion of
inhaled beryllium retained in the lungs for a longer duration, which is
in the range of one-half of the original pulmonary load, may have
significance for pulmonary carcinogenesis. This pulmonary beryllium
burden becomes localized in the cell nuclei and may be an important
factor in eliciting the carcinogenic response associated with beryllium
inhalation.
Groth et al. (1980) (Document ID 1316) conducted a series of
experiments to assess the carcinogenic effects of beryllium, beryllium
hydroxide, and various beryllium alloys. For the beryllium metal/alloys
experiment, 12 groups of 3-month-old female Wistar rats (35 rats/group)
were used. All rats in each group received a single intratracheal
injection of either 2.5 or 0.5 mg of one of the beryllium metals or
beryllium alloys as described in Table 3 below. These materials were
suspended in 0.4 cc of isotonic saline followed by 0.2 cc of saline.
Forty control rats were injected with 0.6 cc of saline. The geometric
mean particle sizes varied from 1 to 2 µm. Rats were sacrificed
and autopsied at various intervals ranging from 1 to 18 months post-
injection.
Table 4--Summary of Beryllium Dose, Based on Groth et al. (1980)
[Document ID 1316]
----------------------------------------------------------------------------------------------------------------
Percent other Total Number Compound
Form of Be Percent Be compounds rats autopsied dose(mg) Be dose(mg)
----------------------------------------------------------------------------------------------------------------
Be metal..................... 100............. None........... 16 2.5 2.5
21 0.5 0.5
Passivated Be metal.......... 99.............. 0.26% Chromium. 26 2.5 2.5
20 0.5 0.5
BeAl alloy................... 62.............. 38% Aluminum... 24 2.5 1.55
21 0.5 0.3
BeCu alloy................... 4............... 96% Copper..... 28 2.5 0.1
24 0.5 0.02
BeCuCo alloy................. 2.4............. 0.4% Cobalt.... 33 2.5 0.06
96% Copper..... 30 0.5 0.012
BeNi alloy................... 2.2............. 97.8% Nickel... 28 2.5 0.056
27 0.5 0.011
----------------------------------------------------------------------------------------------------------------
Lung tumors were observed only in rats exposed to beryllium metal,
passivated beryllium metal, and beryllium-aluminum alloy. Passivation
refers to the process of removing iron contamination from the surface
of beryllium metal. As discussed, metal alloys may have a different
toxicity than beryllium alone. Rats exposed to 100 percent beryllium
exhibited relatively high mortality rates, especially in the groups
where lung tumors were observed. Nodules varying from 1 to 10 mm in
diameter were also observed in the lungs of rats exposed to beryllium
metal, passivated beryllium metal, and beryllium-aluminum alloy. These
nodules were suspected of being malignant.
To test this hypothesis, transplantation experiments involving the
suspicious nodules were conducted in nine rats. Seven of the nine
suspected tumors grew upon transplantation. All transplanted tumor
types metastasized to the lungs of their hosts. Lung tumors were
observed in rats injected with both the high and low doses of beryllium
metal, passivated beryllium metal, and beryllium-aluminum alloy. No
lung tumors were observed in rats injected with the other compounds. Of
a total of 32 lung tumors detected, most were adenocarcinomas and
adenomas; however, two epidermoid carcinomas and at least one poorly
differentiated carcinoma were observed. Bronchiolar alveolar cell
tumors were frequently observed in rats injected with beryllium metal,
passivated beryllium metal, and beryllium-aluminum alloy. All stages of
cuboidal, columnar, and squamous cell metaplasia were observed on the
alveolar walls in the lungs of rats injected with beryllium metal,
passivated beryllium metal, and beryllium-aluminum alloy. These lesions
were generally reduced in size and number or absent from the lungs of
animals injected with the other alloys (BeCu, BeCuCo, BeNi).
The extent of alveolar metaplasia could be correlated with the
incidence of lung cancer. The incidences of lung tumors in the rats
that received 2.5 mg of beryllium metal, and 2.5 and 0.5 mg of
passivated beryllium metal, were significantly different (p <=0.008)
from controls. When autopsies were performed at the 16-to-19-month
interval, the incidence (2/6) of lung tumors in rats exposed to 2.5 mg
of beryllium-aluminum alloy was statistically significant (p = 0.004)
when compared to the lung tumor incidence (0/84) in rats exposed to
BeCu, BeNi, and BeCuCo alloys, which contained much lower
concentrations of Be (Groth et al., 1980, Document ID 1316).
Finch et al. (1998b) (Document ID 1367) investigated the
carcinogenic effects of inhaled beryllium on heterozygous TSG-p53
knockout (p53 +/-) mice and wild-type (p53+/+) mice.
Knockout mice can be valuable tools in determining the role played by
specific genes in the toxicity of a material of interest, in this case
beryllium. Equal numbers of approximately 10-week-old male and female
mice were used for this study. Two exposure groups were used to provide
dose-response information on lung carcinogenicity. The maximum initial
lung burden (ILB) target of 60 μg
beryllium was based on previous acute inhalation exposure studies in
mice. The lower exposure target level of 15 μg was selected to
provide a lung burden significantly less than the high-level group, but
high enough to yield carcinogenic responses. Mice were exposed in
groups to beryllium metal or to filtered air (controls) via nose-only
inhalation. The specific exposure parameters are presented in Table 4
below. Mice were sacrificed 7 days post exposure for ILB analysis, and
either at 6 months post exposure (n = 4-5 mice per group per gender) or
when 10 percent or less of the original population remained (19 months
post exposure for p53 +/- knockout and 22.5 months post
exposure for p53+/+ wild-type mice). The sacrifice time was extended in
the study because a significant number of lung tumors were not observed
at 6 months post exposure.
Table 5--Summary of Animal Data, Based on Finch et al. (1998)
[Document ID 1367]
----------------------------------------------------------------------------------------------------------------
Number of
Target Mean daily mice with 1
Mean exposure beryllium lung Number of exposure Mean ILB or more lung
Mouse strain concentration burden mice duration (μg) tumors/total
(μg Be/L) (μg) (minutes) number
examined
----------------------------------------------------------------------------------------------------------------
Knockout (p53 34 15 30 112 (single) NA 0/29
+/-) 36 60 30 139 NA 4/28
Wild-type (p53 34 15 6 112 (single) 12 4 0/28
54 6
Knockout (p53 NA (air) Control 30 60-180 NA 0/30
+/-) (single)
----------------------------------------------------------------------------------------------------------------
Lung burdens of beryllium measured in wild-type mice at 7 days post
exposure were approximately 70-90 percent of target levels. No
exposure-related effects on body weight were observed in mice; however,
lung weights and lung-to-body-weight ratios were somewhat elevated in
60 μg target ILB p53 +/- knockout mice compared to
controls (0.05 +/- knockout mice and beryllium exposure
tended to decrease survival time in both groups. The incidence of
beryllium-induced lung tumors was marginally higher in the 60 μg
target ILB p53 +/- knockout mice compared to 60 μg target
ILB p53+/+ wild-type mice (p= 0.056). The incidence of lung tumors in
the 60 μg target ILB p53 +/- knockout mice was also
significantly higher than controls (p = 0.048). No tumors developed in
the control mice, 15 μg target ILB p53 +/- knockout mice,
or 60 μg target ILB p53+/+ wild-type mice throughout the length of
the study. Most lung tumors in beryllium-exposed mice were squamous
cell carcinomas, three of four of which were poorly circumscribed and
all of which were associated with at least some degree of granulomatous
pneumonia. The study results suggest that having an inactivated p53
allele is associated with lung tumor progression in p53 +/-
knockout mice. This is based on the significant difference seen in the
incidence of beryllium-induced lung neoplasms for the p53
+/- knockout mice compared with the p53 \+/+\ wild-type
mice. The authors conclude that since there was a relatively late onset
of tumors in the beryllium-exposed p53 +/- knockout mice, a
6-month bioassay in this mouse strain might not be an appropriate model
for lung carcinogenesis (Finch et al., 1998, Document ID 1367).
During the public comment period Materion submitted correspondence
from Dr. Finch speculating on the reason for the less-robust lung
cancer response observed in mice (versus that observed in rats)
(Document ID 1807, Attachment 11, p. 1). Materion contended that this
was support for their assertion of evidence that "directly contradicts
the claims that beryllium metal causes cancer in animals" (Document ID
1807, p. 6). OSHA reviewed this correspondence and disagrees with
Materion's assertion. While Dr. Finch did suggest that the mouse lung
cancer response was less robust, it was still present. Dr. Finch went
on to suggest that while the rat has a more profound neutrophilic
response (typical of a "foreign body response), the mouse has a lung
response more typical of humans (neutrophilic and lymphocytic)
(Document ID 1807, Attachment 11, p. 1).
Nickell-Brady et al. (1994) investigated the development of lung
tumors in 12-week-old F344/N rats after a single nose-only inhalation
exposure to beryllium aerosol, and evaluated whether beryllium lung
tumor induction involves alterations in the K-ras, p53, and c-raf-1
genes (Document ID 1312). Four groups of rats (30 males and 30 females
per group) were exposed to different mass concentrations of beryllium
(Group 1: 500 mg/m3\ for 8 min; Group 2: 410 mg/m3\ for 30 min; Group
3: 830 mg/m3\ for 48 min; Group 4: 980 mg/m3\ for 39 min). The
beryllium mass median aerodynamic diameter was 1.4 μm
([sigma]g= 1.9). The mean beryllium lung burdens for each
exposure group were 40, 110, 360, and 430 μg, respectively.
To examine genetic alterations, DNA isolation and sequencing
techniques (PCR amplification and direct DNA sequence analysis) were
performed on wild-type rat lung tissue (i.e., control samples) along
with two mouse lung tumor cell lines containing known K-ras mutations,
12 carcinomas induced by beryllium (i.e., experimental samples), and 12
other formalin-fixed specimens. Tumors appeared in beryllium-exposed
rats by 14 months, and 64 percent of exposed rats developed lung tumors
during their lifetime. Lungs frequently contained multiple tumor sites,
with some of the tumors greater than 1 cm. A total of 24 tumors were
observed. Most of the tumors (n = 22) were adenocarcinomas exhibiting a
papillary pattern characterized by cuboidal or columnar cells, although
a few had a tubular or solid pattern. Fewer than 10 percent of the
tumors were adenosquamous (n = 1) or squamous cell (n = 1) carcinomas.
No transforming mutations of the K-ras gene (codons 12, 13, or 61)
were detected by direct sequence analysis in any of the lung tumors
induced by beryllium. However, using a more sensitive sequencing
technique (PCR enrichment restriction fragment length polymorphism
(RFLP) analysis) resulted in the detection of K-ras codon 12 GGT to GTT
transversions in 2 of 12 beryllium-induced adenocarcinomas. No p53 or
c-raf-1 alterations were observed in any of the tumors induced by
beryllium exposure (i.e., no differences observed between beryllium-
exposed and control rat tissues). The authors note that the results
suggest that
activation of the K-ras proto-oncogene is both a rare and late event,
possibly caused by genomic instability during the progression of
beryllium-induced rat pulmonary adenocarcinomas. It is unlikely that
the K-ras gene plays a role in the carcinogenicity of beryllium. The
results also indicate that p53 mutation is unlikely to play a role in
tumor development in rats exposed to beryllium.
Belinsky et al. (1997) reviewed the findings by Nickell-Brady et
al. (1994) (Document ID 1312) to further examine the role of the K-ras
and p53 genes in lung tumors induced in the F344 rat by non-mutagenic
(non-genotoxic) exposures to beryllium. Their findings are discussed
along with the results of other genomic studies that look at
carcinogenic agents that are either similarly non-mutagenic or, in
other cases, mutagenic. The authors concluded that the identification
of non-ras transforming genes in rat lung tumors induced by non-
mutagenic exposures, such as beryllium, as well as mutagenic exposures
will help define some of the mechanisms underlying cancer induction by
different types of DNA damage.
The inactivation of the p16 INK4a(p16) gene is a contributing
factor in disrupting control of the normal cell cycle and may be an
important mechanism of action in beryllium-induced lung tumors.
Swafford et al. (1997) investigated the aberrant methylation and
subsequent inactivation of the p16 gene in primary lung tumors induced
in F344/N rats exposed to known carcinogens via inhalation (Document ID
1392). The research involved a total of 18 primary lung tumors that
developed after exposing rats to five agents, one of which was
beryllium. In this study, only one of the 18 lung tumors was induced by
beryllium exposure; the majority of the other tumors were induced by
radiation (x-rays or plutonium-239 oxide). The authors hypothesized
that if p16 inactivation plays a central role in development of non-
small-cell lung cancer, then the frequency of gene inactivation in
primary tumors should parallel that observed in the corresponding cell
lines. To test the hypothesis, a rat model for lung cancer was used to
determine the frequency and mechanism for inactivation of p16 in
matched primary lung tumors and derived cell lines. The methylation-
specific PCR (MSP) method was used to detect methylation of p16
alleles. The results showed that the presence of aberrant p16
methylation in cell lines was strongly correlated with absent or low
expression of the gene. The findings also demonstrated that aberrant
p16 CpG island methylation, an important mechanism in gene silencing
leading to the loss of p16 expression, originates in primary tumors.
Building on the rat model for lung cancer and associated findings
from Swafford et al. (1997) (Document ID 1392), Belinsky et al. (2002)
(Document ID 1300) conducted experiments in 12-week-old F344/N rats
(male and female) to determine whether beryllium-induced lung tumors
involve inactivation of the p16 gene and estrogen receptor α (ER)
gene. Rats received a single nose-only inhalation exposure to beryllium
aerosol at four different exposure levels. The mean lung burdens
measured in each exposure group were 40, 110, 360, and 430 μg. The
methylation status of the p16 and ER genes was determined by MSP. A
total of 20 tumors detected in beryllium-exposed rats were available
for analysis of gene-specific promoter methylation. Three tumors were
classified as squamous cell carcinomas and the others were determined
to be adenocarcinomas. Methylated p16 was present in 80 percent (16/
20), and methylated ER was present in one-half (10/20), of the lung
tumors induced by exposure to beryllium. Additionally, both genes were
methylated in 40 percent of the tumors. The authors noted that four
tumors from beryllium-exposed rats appeared to be partially methylated
at the p16 locus. Bisulfite sequencing of exon 1 of the ER gene was
conducted on normal lung DNA and DNA from three methylated, beryllium-
induced tumors to determine the density of methylation within amplified
regions of exon 1 (referred to as CpG sites). Two of the three
methylated, beryllium-induced lung tumors showed extensive methylation,
with more than 80 percent of all CpG sites methylated.
The overall findings of this study suggest that inactivation of the
p16 and ER genes by promoter hypermethylation are likely to contribute
to the development of lung tumors in beryllium-exposed rats. The
results showed a correlation between changes in p16 methylation and
loss of gene transcription. The authors hypothesize that the mechanism
of action for beryllium-induced p16 gene inactivation in lung tumors
may be inflammatory mediators that result in oxidative stress. The
oxidative stress damages DNA directly through free radicals or
indirectly through the formation of 8-hydroxyguanosine DNA adducts,
resulting primarily in a single-strand DNA break.
Wagner et al. (1969) (Document ID 1481) studied the development of
pulmonary tumors after intermittent daily chronic inhalation exposure
to beryllium ores in three groups of male squirrel monkeys. One group
was exposed to bertrandite ore, a second to beryl ore, and the third
served as unexposed controls. Each of these three exposure groups
contained 12 monkeys. Monkeys from each group were sacrificed after 6,
12, or 23 months of exposure. The 12-month sacrificed monkeys (n = 4
for bertrandite and control groups; n = 2 for beryl group) were
replaced by a separate replacement group to maintain a total animal
population approximating the original numbers and to provide a source
of confirming data for biologic responses that might arise following
the ore exposures. Animals were exposed to bertrandite and beryl ore
concentrations of 15 mg/m3\, corresponding to 210 μg beryllium/m3\
and 620 μg beryllium/m3\ in each exposure chamber, respectively.
The parent ores were reduced to particles with geometric mean diameters
of 0.27 μm ( 2.4) for bertrandite and 0.64 μm ( 2.5) for beryl. Animals were exposed for approximately 6 hours/
day, 5 days/week. The histological changes in the lungs of monkeys
exposed to bertrandite and beryl ore exhibited a similar pattern. The
changes generally consisted of aggregates of dust-laden macrophages,
lymphocytes, and plasma cells near respiratory bronchioles and small
blood vessels. There were, however, no consistent or significant
pulmonary lesions or tumors observed in monkeys exposed to either of
the beryllium ores. This is in contrast to the findings in rats exposed
to beryl ore and to a lesser extent bertrandite, where atypical cell
proliferation and tumors were frequently observed in the lungs. The
authors hypothesized that the rats' greater susceptibility may be
attributed to the spontaneous lung disease characteristic of rats,
which might have interfered with lung clearance.
As previously described, Conradi et al. (1971) investigated changes
in the lungs of monkeys and dogs two years after intermittent
inhalation exposure to beryllium oxide calcined at 1,400 [deg]C
(Document ID 1319). Five adult male and female monkeys (Macaca irus)
weighing between 3 and 5.75 kg were used in the study. The study
included two control monkeys. Beryllium concentrations in the
atmosphere of whole-body exposed monkeys varied between 3.30 and 4.38
mg/m3\. Thirty-minute exposures occurred once a month for three
months, with beryllium oxide concentrations increasing at each exposure
interval. Lung tissue was investigated using electron microscopy
and morphometric methods. Beryllium content in portions of the lungs of
five monkeys was measured two years following exposure by emission
spectrography. The reported concentrations in monkeys (82.5, 143.0, and
112.7 μg beryllium per 100 gm of wet tissue in the upper lobe, lower
lobe, and combined lobes, respectively) were higher than those in dogs.
No neoplastic or granulomatous lesions were observed in the lungs of
any exposed animals and there was no evidence of chronic proliferative
lung changes after two years.
To summarize, animal studies show that multiple forms of beryllium,
when inhaled or instilled in the respiratory tract of rats, mice, and
monkeys, lead to increased incidence of lung tumors. Animal studies
have demonstrated a consistent scenario of beryllium exposure resulting
in chronic pulmonary inflammation and tumor formation at levels below
overload conditions (Groth et al., 1980, Document ID 1316; Finch et
al., 1998 (1367); Nickel-Brady et al., 1994 (1312)). The animal studies
support the human epidemiological evidence and contributed to the
findings of the NTP, IARC, and others that beryllium and beryllium-
containing material should be regarded as known human carcinogens. The
beryllium compounds found to be carcinogenic in animals include both
soluble beryllium compounds, such as beryllium sulfate and beryllium
hydroxide, as well as poorly soluble beryllium compounds, such as
beryllium oxide and beryllium metal. The doses that produce tumors in
experimental animal are fairly large and also lead to chronic pulmonary
inflammation. The exact tumorigenic mechanism for beryllium is unclear
and a number of mechanisms are likely involved, including chronic
inflammation, genotoxicity, mitogenicity, oxidative stress, and
epigenetic changes.
4. In Vitro Studies
The exact mechanism by which beryllium induces pulmonary neoplasms
in animals remains unknown (NAS 2008, Document ID 1355). Keshava et al.
(2001) performed studies to determine the carcinogenic potential of
beryllium sulfate in cultured mammalian cells (Document ID 1362).
Joseph et al. (2001) investigated differential gene expression to
understand the possible mechanisms of beryllium-induced cell
transformation and tumorigenesis (Document ID 1490). Both
investigations used cell transformation assays to study the cellular/
molecular mechanisms of beryllium carcinogenesis and assess
carcinogenicity. Cell lines were derived from tumors developed in nude
mice injected subcutaneously with non-transformed BALB/c-3T3 cells that
were morphologically transformed in vitro with 50-200 μg beryllium
sulfate/ml for 72 hours. The non-transformed cells were used as
controls.
Keshava et al. (2001) found that beryllium sulfate is capable of
inducing morphological cell transformation in mammalian cells and that
transformed cells are potentially tumorigenic (Document ID 1362). A
dose-dependent increase (9-41 fold) in transformation frequency was
noted. Using differential polymerase chain reaction (PCR), gene
amplification was investigated in six proto-oncogenes (K-ras, c-myc, c-
fos, c-jun, c-sis, erb-B2) and one tumor suppressor gene (p53). Gene
amplification was found in c-jun and K-ras. None of the other genes
tested showed amplification. Additionally, Western blot analysis showed
no change in gene expression or protein level in any of the genes
examined. Genomic instability in both the non-transformed and
transformed cell lines was evaluated using random amplified polymorphic
DNA fingerprinting (RAPD analysis). Using different primers, 5 of the
10 transformed cell lines showed genomic instability when compared to
the non-transformed BALB/c-3T3 cells. The results indicate that
beryllium sulfate-induced cell transformation might, in part, involve
gene amplification of K-ras and c-jun and that some transformed cells
possess neoplastic potential resulting from genomic instability.
Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph et
al. (2001) studied the expression profiles of 1,176 genes belonging to
several different functional categories after beryllium sulfate
exposure in a mouse cell line (Document ID 1490). Compared to the
control cells, expression of 18 genes belonging to two functional
groups (nine cancer-related genes and nine DNA synthesis, repair, and
recombination genes) was found to be consistently and reproducibly
different (at least 2-fold) in the tumor cells. Differential gene
expression profile was confirmed using reverse transcription-PCR with
primers specific to the differentially expressed genes. Two of the
differentially expressed genes (c-fos and c-jun) were used as model
genes to demonstrate that the beryllium-induced transcriptional
activation of these genes was dependent on pathways of protein kinase C
and mitogen-activated protein kinase and independent of reactive oxygen
species in the control cells. These results indicate that beryllium-
induced cell transformation and tumorigenesis are associated with up-
regulated expression of the cancer-related genes (such as c-fos, c-jun,
c-myc, and R-ras) and down-regulated expression of genes involved in
DNA synthesis, repair, and recombination (such as MCM4, MCM5, PMS2,
Rad23, and DNA ligase I).
In summary, in vitro studies have been used to evaluate the
neoplastic potential of beryllium compounds and the possible underlying
mechanisms. Both Keshava et al. (2001) (Document ID 1362) and Joseph et
al. (2001) (Document ID 1490) have found that beryllium sulfate induced
a number of onco-genes (c-fos, c-jun, c-myc, and R-ras) and down-
regulated genes responses for normal cellular function and repair
(including those involved in DNA synthesis, repair, and recombination).
5. Lung Cancer Conclusions
OSHA has determined that substantial evidence in the record
indicates that beryllium compounds should be regarded as occupational
lung carcinogens. Many well-respected scientific organizations,
including IARC, NTP, EPA, NIOSH, and ACGIH, have reached similar
conclusions with respect to the carcinogenicity of beryllium.
While some evidence exists for direct-acting genotoxicity as a
possible mechanism for beryllium carcinogenesis, the weight of evidence
suggests that an indirect mechanism, such as inflammation or other
epigenetic changes, may be responsible for most tumorigenic activity of
beryllium in animals and humans (IARC, 2012, Document ID 0650).
Inflammation has been postulated to be a key contributor to many
different forms of cancer (Jackson et al., 2006; Pikarsky et al., 2004;
Greten et al., 2004; Leek, 2002). In fact, chronic inflammation may be
a primary factor in the development of up to one-third of all cancers
(Ames et al., 1990; NCI, 2010).
In addition to a T-cell-mediated immunological response, beryllium
has been demonstrated to produce an inflammatory response in animal
models similar to the response produced by other particles (Reeves et
al., 1967, Document ID 1309; Swafford et al., 1997 (1392); Wagner et
al., 1969 (1481)), possibly contributing to its carcinogenic potential.
Studies conducted in rats have demonstrated that chronic inhalation of
materials similar in solubility to beryllium results in increased
pulmonary inflammation,
fibrosis, epithelial hyperplasia, and, in some cases, pulmonary
adenomas and carcinomas (Heinrich et al., 1995, Document ID 1513; NTP,
1993 (1333); Lee et al., 1985 (1466); Warheit et al., 1996 (1377)).
This response is generally referred to as an "overload" response and
is specific to particles of low solubility with a low order of
toxicity, which are non-mutagenic and non-genotoxic (i.e., poorly
soluble particles like titanium dioxide and non-asbestiform talc); this
response is observed only in rats (Carter et al., 2006, Document ID
1556). "Overload" is described in ECETOC (2013) as inhalation of high
concentrations of low solubility particles resulting in lung burdens
that impair particle clearance mechanisms (ECETOC, 2013 as cited in
Document ID 1807, Attachment 10, p. 3 (pdf p. 87)). Substantial data
indicate that tumor formation in rats after exposure to some poorly
soluble particles at doses causing marked, chronic inflammation is due
to a secondary mechanism unrelated to the genotoxicity (or lack
thereof) of the particle itself. Because these specific particles
(i.e., titanium dioxide and non-asbestiform talc) exhibit no
cytotoxicity or genotoxicity, they are considered to be biologically
inert (ECETOC, 2013; see Document ID 1807, Attachment 10, p. 3 (pdf p.
87)). Animal studies, as summarized above, have demonstrated a
consistent scenario of beryllium exposure resulting in chronic
pulmonary inflammation below an overload scenario. NIOSH submitted
comments describing the findings from a low-dose study of beryllium
metal among male and female F344 rats (Document ID 1960, p. 11). The
study by Finch et al. (2000) indicated lung tumor rates of 4, 4, 12,
50, 61, and 91 percent in animals with beryllium metal lung burdens of
0, 0.3, 1, 3, 10, and 50 μg respectively (Finch et al., 2000 as
cited in Document ID 1960, p. 11). NIOSH noted the lung burden levels
were much lower than those from previous studies, such as a 1998 Finch
et al. study with initial lung burdens of 15 and 60 μg (Document ID
1960, p. 11). Based on evidence from mammalian studies of the
mutagenicity and genotoxicity of beryllium (as described in above in
section V.E.1) and the evidence of tumorigenicity at lung burden levels
well below overload, OSHA concludes that beryllium particles are not
poorly soluble particles like titanium dioxide and non-asbestiform
talc.
It has been hypothesized that the recruitment of neutrophils during
the inflammatory response and subsequent release of oxidants from these
cells play an important role in the pathogenesis of rat lung tumors
(Borm et al., 2004, Document ID 1559; Carter and Driscoll, 2001 (1557);
Carter et al., 2006 (1556); Johnston et al., 2000 (1504); Knaapen et
al., 2004 (1499); Mossman, 2000 (1444)). This is one potential
carcinogenic pathway for beryllium particles. Inflammatory mediators,
acting at levels below overload doses as characterized in many of the
studies summarized above, have been shown to play a significant role in
the recruitment of cells responsible for the release of reactive oxygen
and hydrogen species. These species have been determined to be highly
mutagenic as well as mitogenic, inducing a proliferative response
(Ferriola and Nettesheim, 1994, Document ID 0452; Coussens and Werb,
2002 (0496)). The resultant effect is an environment rich for
neoplastic transformations and the progression of fibrosis and tumor
formation. This is consistent with findings from the National Cancer
Institute, which has estimated that one-third of all cancers may be due
to chronic inflammation (NCI, 2010, Document ID 0532). However, an
inflammation-driven contribution to the neoplastic transformation does
not imply no risk at levels below inflammatory response; rather, the
overall weight of evidence suggests a mechanism of an indirect
carcinogen at levels where inflammation is seen. While tumorigenesis
secondary to inflammation is one reasonable mode of action, other
plausible modes of action independent of inflammation (e.g.,
epigenetic, mitogenic, reactive oxygen mediated, indirect genotoxicity,
etc.) may also contribute to the lung cancer associated with beryllium
exposure. As summarized above, animal studies have consistently
demonstrated beryllium exposure resulting in chronic pulmonary
inflammation below overload conditions in multiple species (Groth et
al., 1980, Document ID 1316; Finch et al., 1998 (1367); Nickel-Brady et
al., 1994 (1312)). While OSHA recognizes chronic inflammation as one
potential pathway to carcinogencity the Agency finds that other
carcinogenic pathways such as genotoxicity and epigenetic changes may
also contribute to beryllium-induced carcinogenesis.
During the public comment period OSHA received several comments on
the carcinogenicity of beryllium. The NFFS agreed with OSHA that "the
science is quite clear in linking these soluble Beryllium compounds"
to lung cancer (Document ID 1678, p. 6). It also, however, contended
that there is considerable scientific dispute regarding the
carcinogenicity of beryllium metal (i.e., poorly soluble beryllium),
citing findings by the EU's REACH Beryllium Commission (later clarified
as the EU Beryllium Science and Technology Association) (Document ID
1785, p. 1; Document ID 1814) and a study by Strupp and Furnes (2010)
(Document ID 1678, pp. 6-7, and Attachment 1). Materion, similarly,
commented that "[a] report conclusion during the recent review of the
European Cancer Directive for the European Commission stated regarding
beryllium: `There was little evidence for any important health impact
from current or recent past exposures in the EU' " (Document ID 1958,
p. 4).
The contentions of both Materion and NFFS regarding scientific
findings from the EU is directly contradicted by the document submitted
to the docket by the European Commission on Health, Safety and Hygiene
at Work, discussed above. This document states that the European
Chemicals Agency (ECHA) has determined that all forms of beryllium
(soluble and poorly soluble) are carcinogenic (Category 1B) with the
exception of aluminum beryllium silicates (which have not been
allocated a classification) (Document ID 1692, pp. 2-3).
OSHA also disagrees with NFFS's other contention that there is a
scientific dispute regarding the carcinogenicity of poorly soluble
forms of beryllium. In coming to the conclusion that all forms of
beryllium and beryllium compounds are carcinogenic, OSHA independently
evaluated the scientific literature, including the findings of
authoritative entities such as NIOSH, NTP, EPA, and IARC (see section
V.E). The evidence from human, animal, and mechanistic studies together
demonstrates that both soluble and poorly soluble beryllium compounds
are carcinogenic (see sections V.E.2, V.E.3, V.E.4). The well-respected
scientific bodies mentioned above came to the same conclusion: That
both soluble and poorly soluble beryllium compounds are carcinogenic to
humans.
As supporting documentation the NFFS submitted an "expert
statement" by Strupp and Furnes (2010), which reviews the
toxicological and epidemiological information regarding beryllium
carcinogenicity. Based on select information in the scientific
literature on lung cancer, the Strupp and Furnes (2010) study concluded
that there was insufficient evidence in humans and animals to conclude
that insoluble (poorly soluble) beryllium was carcinogenic (Document ID
1678, Attachment 1, pp. 21-23). Strupp and Furnes (2010) asserted that
this was based on criteria established under
Annex VI of Directive 67/548/EEC which establishes criteria for
classification and labelling of hazardous substances under the UN
Globally Harmonized System of Classification and Labelling of Chemicals
(GHS). OSHA reviewed the Strupp and Furnes (2010) "expert statement"
submitted by NFFS and found it to be unpersuasive. Its review of the
epidemiological evidence mischaracterized the findings from the NIOSH
cohort and the nested case-control studies (Ward et al., 1992;
Sanderson et al., 2001; Schubauer-Berigan et al., 2008) and
misunderstood the methods commonly used to analyze occupational cohort
studies (Document ID 1725, pp. 27-28).
The Strupp and Furnes statement also did not include the more
recent studies by Schubauer-Berigan et al. (2011, Document ID 1815,
Attachment 105, 2011 (0626)), which demonstrated elevated rates for
lung cancer (SMR 1.17; 95% CI 1.08 to 1.28) in a study of 7 beryllium
processing plants. In addition, Strupp and Furnes did not consider
expert criticism from IARC on the studies by Levy et al. (2007) and
Deubner et al., (2007), which formed the basis of their findings. NIOSH
submitted comments that stated:
The Strupp (2011b) review of the epidemiological evidence for
lung carcinogenicity of beryllium contained fundamental
mischaracterizations of the findings of the NIOSH cohort and nested
case-control studies (Ward et al. 1992; Sanderson et al. 2001;
Schubauer-Berigan et al. 2008), as well as an apparent
misunderstanding of the methods commonly used to analyze
occupational cohort studies (Document ID 1960, Attachment 2, p. 10).
As further noted by NIOSH:
Strupp's epidemiology summary mentions two papers that were
critical of the Sanderson et al. (2001) nested case-control study.
The first of these, Levy et al. (2007a), was a re-analysis that
incorporated a nonstandard method of selecting control subjects and
the second, Deubner et al. (2007), was a simulation study designed
to evaluate Sanderson's study design. Both of these papers have
themselves been criticized for using faulty methods (Schubauer-
Berigan et al. 2007; Kriebel, 2008; Langholz and Richardson, 2008);
however, Strupp's coverage of this is incomplete. (Document ID 1960,
Attachment 2, Appendix, p. 19).
NIOSH went on to state that while the Sanderson et al. (2001) used
standard accepted methods for selecting the control group, the Deubner
et al. (2007) study limited control group eligibility and failed to
adequately match control and case groups (Document ID 1960, Attachment
2, Appendix, pp. 19-20). NIOSH noted that an independent analysis
published by Langholz and Richardson (2009) and Hein et al., (2009) (as
cited in Document ID 1960, Attachment 2, Appendix, p. 20) found that
Levy et al.'s method of eliminating controls from the study had the
effect of "always produc[ing] downwardly biased effect estimates and
for many scenarios the bias was substantial." (Document ID 1960,
Attachment 2, Appendix, p. 20). NIOSH went on to cite numerous errors
in the studies cited by Strupp (2011) (Document ID 1794, 1795).9 OSHA
finds NIOSH's criticisms of the Strupp (2011) studies as well as their
criticism of studies by Levy et al., 2007 and Deubner et al., 2007 to
be reliable and credible.
---------------------------------------------------------------------------
9 Strupp and Furnes was the background information for the
Strupp (2011) publications (Document ID, Attachment 2, Appendix, p.
20).
---------------------------------------------------------------------------
The Strupp and Furnes (2010) statement provided insufficient
information on the extraction of beryllium metal for OSHA to fully
evaluate the merit of the studies regarding potential genotoxicity of
poorly soluble beryllium (Document ID 1678, Attachment 1, pp. 18-20).
In addition, Strupp and Furnes did not consider the peer-reviewed
published studies evaluating the genotoxicity of beryllium metal (see
section V.E.1 and V.E.2).
In coming to the conclusion that the evidence is insufficient for
classification under GHS, Strupp and Furnes failed to consider the full
weight of evidence in their evaluation using the criteria set forth
under Annex VI of Directive 67/548/EEC which establishes criteria for
classification and labelling of hazardous substances under the UN
Globally Harmonized System of Classification and Labelling of Chemicals
(GHS) (Document ID 1678, attachment 1, pp. 21-23). Thus, the Agency
concludes that the Strupp and Furnes statement does not constitute the
best available scientific evidence for the evaluation of whether poorly
soluble forms of beryllium cause cancer.
Materion also submitted comments indicating there is an ongoing
scientific debate regarding the relevance of the rat lung tumor
response to humans with respect to poorly soluble beryllium compounds
(Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)), Materion
contended that the increased lung cancer risk in beryllium-exposed
animals is due to a particle overload phenomenon, in which lung
clearance of beryllium particles initiates a non-specific neutrophilic
response that results in intrapulmonary lung tumors. The materials
cited by Materion as supportive of its argument--Obedorster (1995), a
2009 working paper to the UN Subcommittee on the Globally Harmonized
System of Classification and Labelling of Chemicals (citing ILSI (2000)
as supporting evidence for poorly soluble particles), Snipes (1996),
the Health Risk Assessment Guidance for Metals, ICMM (2007), and ECETOC
(2013)--discuss the inhalation of high exposure levels of poorly
soluble particles in rats and the relevance of these studies to the
human carcinogenic response (Document ID 1807, Attachment 10, pp. 1-3
(pdf pp. 85-87)). Using particles such as titanium dioxide, carbon
black, non-asbestiform talc, coal dust, and diesel soot as models, ILSI
(2000) and ECETOC (2013) describe studies that have demonstrated that
chronic inhalation of poorly soluble particles can result in pulmonary
inflammation, fibrosis, epithelial cell hyperplasia, and adenomas and
carcinomas in rats at exposure levels that exceed lung clearance
mechanisms (the "overload" phenomenon) (ILSI (2000) \10\, p. 2, as
cited in Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)).
---------------------------------------------------------------------------
\10\ It is important to note that the ILSI report states that in
interpreting data from rat studies alone, "in the absence of
mechanistic data to the contrary it must be assumed that the rat
model can identify potential hazards to humans" (ILSI, 2000, p. 2,
as cited in Document ID 1807, Attachment 10, p. 1 (pdf p. 85)). The
report by Oberdorster has similar language to the ILSI report (see
Document ID 1807, Attachment 10, pp. 1, 3 (pdf pp. 85, 87). It
should also be noted that the working paper to the UN Subcommittee
on the Globally Harmonized System of Classification and Labelling of
Chemicals, which cited ILSI (2000), was not adopted and has not been
included in any revision to the GHS (http://www.unece.org/fileadmin/DAM/trans/doc/2009/ac10c4/ST-SG-AC10-C4-34e.pdf).
---------------------------------------------------------------------------
However, these expert reports indicate that the "overload"
phenomenon caused by biologically inert particles (poorly soluble
particles of low cytotoxicity for which there is no evidence of
genotoxicity) is relevant only to the rat species. (Document ID 1807,
Attachment 10, pp. 1-3 (pdf pp. 85-87)). OSHA finds that this model is
not in keeping with the data presented for beryllium for several
reasons. First, beryllium has been shown to be a "biologically
active" particle due to its ability to induce an immune response in
multiple species including humans, has been shown to be genotoxic in
certain mammalian test systems, and induces epigenetic changes (e.g.
DNA methylation) (as described in detail in sections V. D. 6, V.E.1,
V.E.3 and V.E.4). Second, beryllium has been shown to produce lung
tumors after inhalation or instillation in several animal species,
including rats, mice, and monkeys (Finch et al., 1998, Document ID
1367; Schepers et al., 1957 (0458) and 1962 (1414); Wagner et al., 1969
(1481); Belinsky et al., 2002 (1300); Groth et al.,
1980 (1316); Vorwald and Reeves, 1957 (1482); Nickell-Brady et al.,
1994 (1312); Swafford et al., 1997 (1392); IARC, 2012 (1355)). In
addition, poorly soluble beryllium has been demonstrated to produce
chronic inflammation at levels below overload (Groth et al., 1980,
Document ID 1316; Nickell-Brady et al., 1994 (1312); Finch et al., 1998
(1367); Finch et al., 2000 (as cited in Document ID 1960, p. 11)).
In addition, IARC and NAS performed an extensive review of the
available animal studies and their findings were supportive of the OSHA
findings of carcinogenicity (IARC, 2012, Document ID 0650; NAS, 2008
(1355)). OSHA performed an independent evaluation as outlined in
section V.E.3 and found sufficient evidence of tumor formation in
multiple species (rats, mice, and monkeys) after inhalation at levels
below overload conditions. The Agency has found evidence supporting the
hypothesis that multiple mechanisms may be at work in the development
of cancer in experimental animals and humans and cannot dismiss the
roles of inflammation (neutrophilic and T-cell mediated), genotoxicity,
and epigenetic factors (see section V.E.1, V.E. 3, V.E.4). After
evaluating the best scientific evidence available from epidemiological
and animal studies (see section V.E) OSHA concludes the weight of
evidence supports a mechanistic finding that both soluble and poorly
soluble forms of beryllium and beryllium-containing compounds are
carcinogenic.
F. Other Health Effects
Past studies on other health effects have been thoroughly reviewed
by several scientific organizations (NTP, 1999, Document ID 1341; EPA,
1998 (0661); ATSDR, 2002 (1371); WHO, 2001 (1282); HSDB, 2010 (0533)).
These studies include summaries of animal studies, in vitro studies,
and human epidemiological studies associated with cardiovascular,
hematological, hepatic, renal, endocrine, reproductive, ocular and
mucosal, and developmental effects. High-dose exposures to beryllium
have been shown to have an adverse effect upon a variety of organs and
tissues in the body, particularly the liver. The adverse systemic
effects on humans mostly occurred prior to the introduction of
occupational and environmental standards set in 1970-1972 OSHA, 1971,
see 39 FR 23513; EPA, 1973 (38 FR 8820)). (OSHA, 1971, see 39 FR 23513;
ACGIH, 1971 (0543); ANSI, 1970 (1303)) and EPA, 1973 (38 FR 8820) and
therefore are less relevant today than in the past. The available data
is fairly limited. The hepatic, cardiovascular, renal, and ocular and
mucosal effects are briefly summarized below. Health effects in other
organ systems listed above were only observed in animal studies at very
high exposure levels and are, therefore, not discussed here. During the
public comment period OSHA received comments suggesting that OSHA add
dermal effects to this section. Therefore, dermal effects have been
added, below, and are also discussed in the section on kinetics and
metabolism (section V.B.2).
1. Hepatic Effects
Beryllium has been shown to accumulate in the liver and a
correlation has been demonstrated between beryllium content and hepatic
damage. Different compounds have been shown to distribute differently
within the hepatic tissues. For example, in one study, beryllium
phosphate accumulated almost exclusively within sinusoidal (Kupffer)
cells of the liver, while beryllium sulfate was found mainly in
parenchymal cells. Conversely, beryllium sulphosalicylic acid complexes
were rapidly excreted (Skilleter and Paine, 1979, Document ID 1410).
According to a few autopsies, beryllium-laden livers had central
necrosis, mild focal necrosis and inflammation, as well as,
occasionally, beryllium granuloma (Sprince et al., 1975, Document ID
1405).
2. Cardiovascular Effects
Severe cases of CBD can result in cor pulmonale, which is
hypertrophy of the right heart ventricle. In a case history study of 17
individuals exposed to beryllium in a plant that manufactured
fluorescent lamps, autopsies revealed right atrial and ventricular
hypertrophy (Hardy and Tabershaw, 1946, Document ID 1516). It is not
likely that these cardiac effects were due to direct toxicity to the
heart, but rather were a response to impaired lung function. However,
an increase in deaths due to heart disease or ischemic heart disease
was found in workers at a beryllium manufacturing facility (Ward et
al., 1992, Document ID 1378). Additionally, a study by Schubauer-
Berigan et al. (2011) found an increase in mortality due to cor
pulmonale in a follow-up study of workers at seven beryllium processing
plants who were exposed to beryllium levels near the preceding OSHA PEL
of 2.0 μg/m3\ (Schubauer-Berigan et al., 2011, Document ID 1266).
Animal studies performed in monkeys indicate heart enlargement
after acute inhalation exposure to 13 mg beryllium/m3\ as beryllium
hydrogen phosphate, 0.184 mg beryllium/m3\ as beryllium fluoride, or
0.198 mg beryllium/m3\ as beryllium sulfate (Schepers, 1957, Document
ID 0458). Decreased arterial oxygen tension was observed in dogs
exposed to 30 mg beryllium/m3\ as beryllium oxide for 15 days (HSDB,
2010, Document ID 0533), 3.6 mg beryllium/m3\ as beryllium oxide for
40 days (Hall et al., 1950, Document ID 1494), and 0.04 mg beryllium/
m3\ as beryllium sulfate for 100 days (Stokinger et al., 1950,
Document ID 1484). These are thought to be indirect effects on the
heart due to pulmonary fibrosis and toxicity, which can increase
arterial pressure and restrict blood flow.
3. Renal Effects
Renal or kidney stones have been found in severe cases of CBD that
resulted from high levels of beryllium exposure. Renal stones
containing beryllium occurred in about 10 percent of patients affected
by high exposures (Barnett et al., 1961, Document ID 0453). The ATSDR
reported that 10 percent of the CBD cases found in the BCR reported
kidney stones. In addition, an excess of calcium in the blood and urine
was frequently found in patients with CBD (ATSDR, 2002, Document ID
1371).
4. Ocular and Mucosal Effects
Soluble and poorly soluble beryllium compounds have been shown to
cause ocular irritation in humans (VanOrdstrand et al., 1945, Document
ID 1383; De Nardi et al., 1953 (1545); Nishimura, 1966 (1435); Epstein,
1991 (0526); NIOSH, 1994 (1261). In addition, soluble and poorly
soluble beryllium has been shown to induce acute conjunctivitis with
corneal maculae and diffuse erythema (HSDB, 2010, Document ID 0533).
The mucosa (mucosal membrane) is the moist lining of certain
tissues/organs including the eyes, nose, mouth, lungs, and the urinary
and digestive tracts. Soluble beryllium salts have been shown to be
directly irritating to mucous membranes (HSDB, 2010, Document ID 0533).
5. Dermal Effects
Several commenters suggested OSHA add dermal effects to this Health
Effects section. National Jewish Health noted that rash and
granulomatous reactions of the skin still occur in occupational
settings (Document ID 1664, p. 5). The National Supplemental Screening
Program also recommended including skin conditions such as dermatitis
and nodules (Document ID 1677, p. 3). The American Thoracic Society
also recommended including "beryllium sensitization, CBD, and skin
disease as the major adverse health effects
associated with exposure to beryllium at or below 0.1 μg/m3\ and
acute beryllium disease at higher exposures based on the currently
available epidemiologic and experimental studies" (Document ID 1688,
p. 2). OSHA agrees and has included dermal effects in this section of
the final preamble.
As summarized in Epstein (1991), skin exposure to soluble beryllium
compounds (mainly beryllium fluoride but also beryllium metal which may
contain beryllium fluoride) resulted in irritant dermatitis with
inflammation, and local edema. Beryllium oxide, beryllium alloys and
nearly pure beryllium metal did not produce such responses in the skin
of workers (Epstein, 1991, Document ID 0526). Skin lacerations or
abrasions contaminated with soluble beryllium can lead to skin
ulcerations (Epstein, 1991, Document ID 0526). Soluble and poorly
soluble beryllium-compounds that penetrate the skin as a result of
abrasions or cuts have been shown to result in chronic ulcerations and
skin granulomas (VanOrdstrand et al., 1945, Document ID 1383; Lederer
and Savage, 1954 (1467)). However, ulcerating granulomatous formation
of the skin is generally associated with poorly soluble forms of
beryllium (Epstein, 1991, Document ID 0526). Beryllium, beryllium oxide
and other soluble and poorly soluble forms of beryllium have been
classified as a skin irritant (category 2) in accordance with the EU
Classification, Labelling and Packaging Regulation (Document ID 1669,
p. 2). Contact dermatitis (skin hypersensitivity) was observed in some
individuals exposed via skin to soluble forms of beryllium, especially
individuals with a dermal irritant response (Epstein, 1991, Document ID
0526). Contact allergy has been observed in workers exposed to
beryllium chloride (Document ID 0522).
G. Summary of Conclusions Regarding Health Effects
Through careful analysis of the best available scientific
information outlined in this section, OSHA has determined that
beryllium and beryllium-containing compounds can cause sensitization,
CBD, and lung cancer. The Agency has determined through its review and
evaluation of the studies outlined in section V.A.2 of this health
effects section that skin and inhalation exposure to beryllium can lead
to sensitization; and inhalation exposure, or skin exposure coupled
with inhalation, can cause onset and progression of CBD. In addition,
the Agency's review and evaluation of the studies outlined in section
V.E. of this health effects section led to a finding that inhalation
exposure to beryllium and beryllium-containing materials can cause lung
cancer.
1. OSHA's Evaluation of the Evidence Finds That Beryllium Causes
Sensitization Below the Preceding PEL and Sensitization is a Precursor
to CBD
Through the biological and immunological processes outlined in
section V.B. of the Health Effects, the Agency has concluded that the
scientific evidence supports the following mechanisms for the
development of sensitization and CBD.
Inhaled beryllium and beryllium-containing materials able
to be retained and solubilized in the lungs have the ability to
initiate sensitization and facilitate CBD development (section V.B.5).
Genetic susceptibility may play a role in the development of
sensitization and progression to CBD in certain individuals.
Beryllium compounds that dissolve in biological fluids,
such as sweat, can penetrate intact skin and initiate sensitization
(section V.A.2; V.B). Phagosomal fluid and lung fluid have the capacity
to dissolve beryllium compounds in the lung (section V.A.2a).
Sensitization occurs through a T-cell mediated process
with both soluble and poorly soluble beryllium and beryllium-containing
compounds through direct antigen presentation or through further
antigen processing in the skin or lung. T-cell mediated responses, such
as sensitization, are generally regarded as long-lasting (e.g., not
transient or readily reversible) immune conditions (section V.D.1).
Beryllium sensitization and CBD are adverse events along a
pathological continuum in the disease process with sensitization being
the necessary first step in the progression to CBD (section V.D).
Particle characteristics such as size, solubility, surface
area, and other properties may play a role in the rate of development
of beryllium sensitization and CBD. However, there is currently not
sufficient information to delineate the biological role these
characteristics may play.
Animal studies have provided supporting evidence for T-
cell proliferation in the development of granulomatous lung lesions
after beryllium exposure (sections V.D.2; V.D.6).
Since the pathogenesis of CBD involves a beryllium-
specific, cell-mediated immune response, CBD cannot occur in the
absence of beryllium sensitization (section V.D.1). While no clinical
symptoms are associated with sensitization, a sensitized worker is at
risk of developing CBD when inhalation exposure to beryllium has
occurred. Epidemiological evidence that covers a wide variety of
beryllium compounds and industrial processes demonstrates that
sensitization and CBD are continuing to occur at present-day exposures
below OSHA's preceding PEL (sections V.D.4; V.D.5 and section VI of
this preamble).
OSHA considers CBD to be a progressive illness with a
continuous spectrum of symptoms ranging from its earliest asymptomatic
stage following sensitization through to full-blown CBD and death
(section V.D.7).
Genetic variabilities appear to enhance risk for
developing sensitization and CBD in some groups (section V.D.3).
In addition, epidemiological studies outlined in section V.D.5 have
demonstrated that efforts to reduce exposures have succeeded in
reducing the frequency of sensitization and CBD.
2. OSHA's Evaluation of the Evidence Has Determined Beryllium To Be a
Human Carcinogen
OSHA conducted an evaluation of the available scientific
information regarding the carcinogenic potential of beryllium and
beryllium-containing compounds (section V.E). Based on the weight of
evidence and plausible mechanistic information obtained from in vitro
and in vivo animal studies as well as clinical and epidemiological
investigations, the Agency has determined that beryllium and beryllium-
containing materials are properly regarded as human carcinogens. This
information is in accordance with findings from IARC, NTP, EPA, NIOSH,
and ACGIH (section V.E). Key points from this analysis are summarized
briefly here.
Epidemiological cohort studies have reported statistically
significant excess lung cancer mortality among workers employed in U.S.
beryllium production and processing plants during the 1930s to 1970s
(section V.E.2).
Significant positive associations were found between lung
cancer mortality and both average and cumulative beryllium exposures
when appropriately adjusted for birth cohort and short-term work status
(section V.E.2).
Studies in which large amounts of different beryllium
compounds were inhaled or instilled in the respiratory tracts in
multiple species of laboratory animals resulted in an increased
incidence of lung tumors (section V.E.3).
Authoritative scientific organizations, such as the IARC,
NTP, and EPA, have classified beryllium as a known or probable human
carcinogen (section V.E).
While OSHA has determined there is sufficient evidence of beryllium
carcinogenicity, the Agency acknowledges that the exact tumorigenic
mechanism for beryllium has yet to be determined. A number of
mechanisms are likely involved, including chronic inflammation,
genotoxicity, mitogenicity, oxidative stress, and epigenetic changes
(section V.E.3).
Studies of beryllium-exposed animals have consistently
demonstrated chronic pulmonary inflammation after exposure (section
V.E.3). Substantial data indicate that tumor formation in certain
animals after inhalation exposure to poorly soluble particles at doses
causing marked, chronic inflammation is due to a secondary mechanism
unrelated to the genotoxicity of the particles (section V.E.5).
A review conducted by the NAS (2008) (Document ID 1355)
found that beryllium and beryllium-containing compounds tested positive
for genotoxicity in nearly 50 percent of studies without exogenous
metabolic activity, suggesting a possible direct-acting mechanism may
exist (section V.E.1) as well as the potential for epigenetic changes
(section V.E.4).
Other health effects are discussed in sections F of the Health
Effects Section and include hepatic, cardiovascular, renal, ocular, and
mucosal effects. The adverse systemic effects from human exposures
mostly occurred prior to the introduction of occupational and
environmental standards set in 1970-1973 (ACGIH, 1971, Document ID
0543; ANSI, 1970 (1303); OSHA, 1971, see 39 FR 23513; EPA, 1973 (38 FR
8820)) and therefore are less relevant.
VI. Risk Assessment
To promulgate a standard that regulates workplace exposure to toxic
materials or harmful physical agents, OSHA must first determine that
the standard reduces a "significant risk" of "material impairment."
Section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b). The first part of
this requirement, "significant risk," refers to the likelihood of
harm, whereas the second part, "material impairment," refers to the
severity of the consequences of exposure. Section II, Pertinent Legal
Authority, of this preamble addresses the statutory bases for these
requirements and how they have been construed by the Supreme Court and
federal courts of appeals.
It is OSHA's practice to evaluate risk to workers and determine the
significance of that risk based on the best available evidence. Using
that evidence, OSHA identifies material health impairments associated
with potentially hazardous occupational exposures, assesses whether
exposed workers' risks are significant, and determines whether a new or
revised rule will substantially reduce these risks. As discussed in
Section II, Pertinent Legal Authority, when determining whether a
significant risk exists OSHA considers whether there is a risk of at
least one-in-a-thousand of developing amaterial health impairment from
a working lifetime of exposure at the prevailing OSHA standard
(referred to as the "preceding standard" or "preceding TWA PEL" in
this preamble). For this purpose, OSHA generally assumes that a term of
45 years constitutes a working life. The Supreme Court has found that
OSHA is not required to support its finding of significant risk with
scientific certainty, but may instead rely on a body of reputable
scientific thought and may make conservative assumptions (i.e., err on
the side of protecting the worker) in its interpretation of the
evidence (see Section II, Pertinent Legal Authority).
For single-substance standards governed by section 6(b)(5) of the
OSH Act, 29 U.S.C. 655(b)(5), OSHA sets a permissible exposure limit
(PEL) based on its risk assessment as well as feasibility
considerations. These health and risk determinations are made in the
context of a rulemaking record in which the body of evidence used to
establish material impairment, assess risks, and identify affected
worker population, as well as the Agency's preliminary risk assessment,
are placed in a public rulemaking record and subject to public comment.
Final determinations regarding the standard, including final
determinations of material impairment and risk, are thus based on
consideration of the entire rulemaking record.
OSHA's approach for the risk assessment for beryllium incorporates
both: (1) A review of the literature on populations of workers exposed
to beryllium at and below the preceding time-weighted average
permissible exposure limit (TWA PEL) of 2 μg/m3\; and (2) OSHA's
own analysis of a data set of beryllium-exposed machinists. The
Preliminary Risk Assessment included in the NPRM evaluated risk at
several alternate TWA PELs that the Agency was considering (1 μg/
m3\, 0.5 μg/m3\, 0.2 μg/m3\, and 0.1 μg/m3\), as well as
OSHA's preceding TWA PEL of 2 μg/m3\. OSHA's risk assessment relied
on available epidemiological studies to evaluate the risk of
sensitization and CBD for workers exposed to beryllium at and below the
preceding TWA PEL and the effectiveness of exposure control programs in
reducing risk. OSHA also conducted a statistical analysis of the
exposure-response relationship for sensitization and CBD at the
preceding PEL and alternate PELs the Agency was considering. For this
analysis, OSHA used data provided by National Jewish Health (NJH), a
leading medical center specializing in the research and treatment of
CBD, on a population of workers employed at a beryllium machining plant
in Cullman, AL. The review of the epidemiological studies and OSHA's
own analysis both show significant risk of sensitization and CBD among
workers exposed at and below the preceding TWA PEL of 2 μg/m3\.
They also show substantial reduction in risk where employers
implemented a combination of controls, including stringent control of
airborne beryllium levels and additional measures, such as respirators
and dermal personal protective equipment (PPE) to further protect
workers against dermal contact and airborne beryllium exposure.
To evaluate lung cancer risk, OSHA relied on a quantitative risk
assessment published in 2011 by Schubauer-Berigan et al. (Document ID
1265). Schubauer-Berigan et al. found that lung cancer risk was
strongly and significantly related to mean, cumulative, and maximum
measures of workers' exposure; the authors predicted significant risk
of lung cancer at the preceding TWA PEL, and substantial reductions in
risk at the alternate PELs OSHA considered in the proposed rule,
including the final TWA PEL of 0.2 μg/m3\ (Schubauer-Berigan et
al., 2011).
OSHA requested input on the preliminary risk assessment presented
in the NPRM, and received comments from a variety of public health
experts and organizations, unions, industrial organizations, individual
employers, and private citizens. While many comments supported OSHA's
general approach to the risk assessment and the conclusions of the risk
assessment, some commenters raised specific concerns with OSHA's
analytical methods or recommended additional studies for OSHA's
consideration. Comments about the risk assessment as a whole are
reviewed here, while comments on specific aspects of the risk
assessment are addressed in the relevant sections throughout the
remainder of
this chapter and in the background document, Risk Analysis of the NJH
Data Set from the Beryllium Machining Facility in Cullman, Alabama--CBD
and Sensitization (OSHA, 2016), which can be found in the rulemaking
docket (docket number OSHA-H005C-2006-0870) at www.regulations.gov.
Following OSHA's review of all the comments submitted on the
preliminary risk assessment, and its incorporation of suggested changes
to the risk assessment, where appropriate, the Agency reaffirms its
conclusion that workers' risk of material impairment of health from
beryllium exposure at the preceding PEL of 2 μg/m3\ is significant,
and is substantially reduced but still significant at the new PEL of
0.2 μg/m3\ (see this preamble at Section VII, Significance of
Risk).
The comments OSHA received on its preliminary risk analysis
generally supported OSHA's overall approach and conclusions. NIOSH
indicated that OSHA relied on the best available evidence in its risk
assessment and concurred with "OSHA's careful review of the available
literature on [beryllium sensitization] and CBD, OSHA's recognition of
dermal exposure as a potential pathway for sensitization, and OSHA's
careful approach to assessing risk for [beryllium sensitization] and
CBD" (Document ID 1725, p. 3). NIOSH agreed with OSHA's approach to
the preliminary lung cancer risk assessment (Document ID 1725, p. 7)
and the selection of a 2011 analysis (Schubauer-Berigan et al., 2011,
Document ID 1265) as the basis of that risk assessment (Document ID
1725, p. 7). NIOSH further supported OSHA's preliminary conclusions
regarding the significance of risk of material health impairment at the
preceding TWA PEL of 2 μg/m3\, and the substantial reduction of
such risk at the new TWA PEL of 0.2 μg/m3\ (Document ID 1725, p.
3). Finally, NIOSH agreed with OSHA's preliminary conclusion that
compliance with the new PEL would lessen but not eliminate risk to
exposed workers, noting that OSHA likely underestimated the risks of
beryllium sensitization and CBD (Document ID 1725, pp. 3-4).
Other commenters also agreed with the general approach and
conclusions of OSHA's preliminary risk assessment. NJH, for example,
determined that "OSHA performed a thorough assessment of risk for
[beryllium sensitization], CBD and lung cancer using all available
studies and literature" (Document ID 1664, p. 5). Dr. Kenny Crump and
Ms. Deborah Proctor commented, on behalf of beryllium producer
Materion, that they "agree with OSHA's conclusion that there is a
significant risk (>1/1000 risk of CBD) at the [then] current PEL, and
that risk is reduced at the proposed PEL (0.2 μg/m3\) in
combination with stringent measures (ancillary provisions) to reduce
worker's exposures" (Document ID 1660, p. 2). They further stated that
OSHA's "finding is evident based on the available literature . . . and
the prevalence data [OSHA] presented for the Cullman facility"
(Document ID 1660, p. 2).
OSHA also received comments objecting to OSHA's conclusions
regarding risk of lung cancer from beryllium exposure and suggesting
additional published analyses for OSHA's consideration (e.g., Document
ID 1659; 1661, pp. 1-3). One comment critiqued the statistical
exposure-response model OSHA presented as one part of its preliminary
risk analysis for sensitization and CBD (Document ID 1660). These
comments are discussed and addressed in the remainder of this chapter.
A. Review of Epidemiological Literature on Sensitization and Chronic
Beryllium Disease
As discussed in the Health Effects section, studies of beryllium-
exposed workers conducted using the beryllium lymphocyte proliferation
test (BeLPT) have found high rates of beryllium sensitization and CBD
among workers in many industries, including at some facilities where
exposures were primarily below OSHA's preceding PEL of 2 μg/m3\
(e.g., Kreiss et al., 1993, Document ID 1478; Henneberger et al., 2001
(1313); Schuler et al., 2005 (0919); Schuler et al., 2012 (0473)). In
the mid-1990s, some facilities using beryllium began to aggressively
monitor and reduce workplace exposures. In the NPRM, OSHA reviewed
studies of workers at four plants where several rounds of BeLPT
screening were conducted before and after implementation of new
exposure control methods. These studies provide the best available
evidence on the effectiveness of various exposure control measures in
reducing the risk of sensitization and CBD. The experiences of these
plants--a copper-beryllium processing facility in Reading, PA, a
ceramics facility in Tucson, AZ, a beryllium processing facility in
Elmore, OH, and a machining facility in Cullman, AL--show that
comprehensive exposure control programs that used engineering controls
to reduce airborne exposure to beryllium, required the use of
respiratory protection, controlled dermal contact with beryllium using
PPE, and employed stringent housekeeping methods to keep work areas
clean and prevent transfer of beryllium between work areas, sharply
curtailed new cases of sensitization among newly-hired workers. In
contrast, efforts to prevent sensitization and CBD by using engineering
controls to reduce workers' beryllium exposures to median levels around
0.2 μg/m3\, with no corresponding emphasis on PPE, were less
effective than comprehensive exposure control programs implemented more
recently. OSHA also reviewed additional, but more limited, information
on the occurrence of sensitization and CBD among workers with low-level
beryllium exposures at nuclear facilities and aluminum smelting plants.
A summary discussion of the experiences at all of these facilities is
provided in this section. Additional discussion of studies on these
facilities and several other studies of sensitization and CBD among
beryllium-exposed workers is provided in Section V, Health Effects.
The Health Effects section also discusses OSHA's findings and the
supporting evidence concerning the role of particle characteristics and
beryllium compound solubility in the development of sensitization and
CBD among beryllium-exposed workers. First, it finds that respirable
particles small enough to reach the deep lung are responsible for CBD.
However, larger inhalable particles that deposit in the upper
respiratory tract may lead to sensitization. Second, it finds that both
soluble and poorly soluble forms of beryllium are able to induce
sensitization and CBD. Poorly soluble forms of beryllium that persist
in the lung for longer periods may pose greater risk of CBD while
soluble forms may more easily trigger immune sensitization. Although
particle size and solubility may influence the toxicity of beryllium,
the available data are too limited to reliably account for these
factors in the Agency's estimates of risk.
1. Reading, PA, Plant
Schuler et al. (2005, Document ID 0919) and Thomas et al. (2009,
Document ID 0590) conducted studies of workers at a copper-beryllium
processing facility in Reading, PA. Exposures at this plant were
believed to be low throughout its history due to both the low
percentage of beryllium in the metal alloys used and the relatively low
exposures found in general area samples collected starting in 1969
(sample median <=0.1 μg/m3\, 97% < 0.5 μg/m3\) (Schuler et al.,
2005). Ninety-nine percent of personal lapel sample measurements were
below the preceding OSHA TWA PEL of 2 μg/m3\; 93 percent were below
the new TWA
PEL of 0.2 μg/m3\ (Schuler et al., 2005). Schuler et al. (2005)
screened 152 workers at the facility with the BeLPT in 2000. The
reported prevalences of sensitization (6.5 percent) and CBD (3.9
percent) showed substantial risk at this facility, even though airborne
exposures were primarily below both the preceding and final TWA
PELs.\11\ The only group of workers with no cases of sensitization or
CBD, a group of 26 office administration workers, was the group with
the lowest recorded exposures (median personal sample 0.01 μg/m3\,
range <0.01-0.06 μg/m3\ (Schuler et al., 2005).
---------------------------------------------------------------------------
\11\ Although OSHA reports percentages to indicate the risks of
sensitization and CBD in this section, the benchmark OSHA typically
uses to demonstrate significant risk, as discussed in Pertinent
Legal Authority, is greater than or equal to 1 in 1,000 workers. One
in 1,000 workers is equivalent to 0.1 percent. Therefore, any value
of 0.1 percent or higher when reporting occurrence of a health
effect is considered by OSHA to indicate a significant risk.
---------------------------------------------------------------------------
After the initial BeLPT screening was conducted in 2000, the
company began implementing new measures to further reduce workers'
exposure to beryllium (Thomas et al. 2009, Document ID 0590).
Requirements designed to minimize dermal contact with beryllium,
including long-sleeve facility uniforms and polymer gloves, were
instituted in production areas in 2000-2002. In 2001, the company
installed local exhaust ventilation (LEV) in die grinding and polishing
operations (Thomas et al., 2009, Figure 1). Personal lapel samples
collected between June 2000 and December 2001, showed reduced exposures
plant-wide (98 percent were below 0.2 μg/m3\). Median, arithmetic
mean, and geometric mean values less than or equal to 0.03 μg/m3\
were reported in this period for all processes except one, a wire
annealing and pickling process. Samples for this process remained
elevated, with a median of 0.1 μg/m3\ (arithmetic mean of 0.127
μg/m3\, geometric mean of 0.083 μg/m3\) (Thomas et al., 2009,
Table 3). In January 2002, the company enclosed the wire annealing and
pickling process in a restricted access zone (RAZ). Beginning in 2002,
the company required use of powered air-purifying respirators (PAPRs)
in the RAZ, and implemented stringent measures to minimize the
potential for skin contact and beryllium transfer out of the zone, such
as requiring RAZ workers to shower before leaving the zone (Thomas et
al., 2009, Figure 1). While exposure samples collected by the facility
were sparse following the enclosure, they suggest exposure levels
comparable to the 2000-2001 samples in areas other than the RAZ (Thomas
et al., 2009, Table 3). The authors reported that outside the RAZ,
"the vast majority of employees do not wear any form of respiratory
protection due to very low airborne beryllium concentrations" (Thomas
et al., 2009, p. 122).
To test the efficacy of the new measures in preventing
sensitization and CBD, in June 2000 the facility began an intensive
BeLPT screening program for all new workers (Thomas et al., 2009,
Document ID 0590). Among 82 workers hired after 1999, three cases of
sensitization were found (3.7 percent). Two (5.4 percent) of 37 workers
hired prior to enclosure of the wire annealing and pickling process,
which had been releasing beryllium into the surrounding area, were
found to be sensitized within 3 and 6 months of beginning work at the
plant. One (2.2 percent) of 45 workers hired after the enclosure was
built was confirmed as sensitized. From these early results comparing
the screening conducted on workers hired before 2000 and those hired in
2000 and later, especially following the enclosure of the RAZ, it
appears that the greatest reduction in sensitization risk (to one
sensitized worker, or 2.2 percent) was achieved after workers'
exposures were reduced to below 0.1 μg/m3\ and PPE to prevent
dermal contact was instituted (Thomas et al., 2009).
2. Tucson, AZ, Plant
Kreiss et al. (1996, Document ID 1477), Cummings et al. (2007,
Document ID 1369), and Henneberger et al. (2001, Document ID 1313)
conducted studies of workers at a beryllia ceramics plant in Tucson,
Arizona. Kreiss et al. (1996) screened 136 workers at this plant with
the BeLPT in 1992. Full-shift area samples collected between 1983 and
1992 showed primarily low airborne beryllium levels at this facility
(76 percent of area samples were at or below 0.1 μg/m3\ and less
than 1 percent exceeded 2 μg/m3\). 4,133 short-term breathing zone
measurements collected between 1981 and 1992 had a median of 0.3 μg/
m3\. A small set (75) of personal lapel samples collected at the plant
beginning in 1991 had a median of 0.2 μg/m3\ and ranged from 0.1 to
1.8 μg/m3\ (arithmetic and geometric mean values not reported)
(Kreiss et al., 1996).
Kreiss et al. reported that eight (5.9 percent) of the 136 workers
tested in 1992 were sensitized, six (4.4 percent) of whom were
diagnosed with CBD. One sensitized worker was one of 13 administrative
workers screened, and was among those diagnosed with CBD. Exposures of
administrative workers were not well characterized, but were believed
to be among the lowest in the plant. Personal lapel samples taken on
administrative workers during the 1990s were below the detection limit
at the time, 0.2 μg/m3\ (Cummings et al., 2007, Document ID 1369).
Following the 1992 screening, the facility reduced exposures in
machining areas (for example, by enclosing additional machines and
installing additional exhaust ventilation), resulting in median
exposures of 0.2 μg/m3\ in production jobs and 0.1 μg/m3\ in
production support jobs (Cummings et al., 2007). In 1998, a second
screening found that 7 out of 74 tested workers hired after the 1992
screening (9.5 percent) were sensitized, one of whom was diagnosed with
CBD. All seven of these sensitized workers had been employed at the
plant for less than two years (Henneberger et al., 2001, Document ID
1313, Table 3). Of 77 Tucson workers hired prior to 1992 who were
tested in 1998, 8 (10.4 percent) were sensitized and 7 of these (9.7
percent) were diagnosed with CBD (Henneberger et al., 2001).
Following the 1998 screening, the company continued efforts to
reduce exposures, along with risk of sensitization and CBD, by
implementing additional engineering and administrative controls and a
comprehensive PPE program which included the use of respiratory
protection (1999) and latex gloves (2000) (Cummings et al., 2007,
Document ID 1369). Enclosures were installed for various beryllium-
releasing processes by 2001. Between 2000 and 2003, water-resistant or
water-proof garments, shoe covers, and taped gloves were incorporated
to keep beryllium-containing fluids from wet machining processes off
the skin. To test the efficacy of the new measures instituted after
1998, in January 2000 the company began screening new workers for
sensitization at the time of hire and at 3, 6, 12, 24, and 48 months of
employment. These more stringent measures appear to have substantially
reduced the risk of sensitization among new employees. Of 97 workers
hired between 2000 and 2004, one case of sensitization was identified
(1 percent) (Cummings et al., 2007).
3. Elmore, OH, Plant
Kreiss et al. (1997, Document ID 1360), Bailey et al. (2010,
Document ID 0676), and Schuler et al. (2012, Document ID 0473)
conducted studies of workers at a beryllium metal, alloy, and oxide
production plant in Elmore, Ohio. Workers participated in several
plant-wide BeLPT surveys beginning in 1993-1994 (Kreiss et al., 1997;
Schuler et al., 2012) and in a series of screenings
for workers hired in 2000 and later, conducted beginning in 2000
(Bailey et al., 2010).
Exposure levels at the plant between 1984 and 1993 were
characterized using a mixture of general area, short-term breathing
zone, and personal lapel samples (Kreiss et al., 1997, Document ID
1360). Kreiss et al. reported that the median area samples for various
work areas ranged from 0.1 to 0.7 µg/m3\, with the highest
values in the alloy arc furnace and alloy melting-casting areas.
Personal lapel samples were available from 1990-1992, and showed high
exposures overall (median value of 1.0 µg/m3\), with very high
exposures for some processes. Kreiss et al. reported median sample
values from the personal lapel samples of 3.8 µg/m3\ for
beryllium oxide production, 1.75 µg/m3\ for alloy melting and
casting, and 1.75 µg/m3\ for the arc furnace. The authors
reported that 43 (6.9 percent) of 627 workers tested in 1993-1994 were
sensitized. 29 workers (including 5 previously identified) were
diagnosed with CBD (29/632, or 4.6 percent) (Kreiss et al., 1997).
In 1996-1999, the company took further steps to reduce workers'
beryllium exposures, including enclosure of some beryllium-releasing
processes, establishment of restricted-access zones, and installation
or updating of certain engineering controls (Bailey et al., 2010,
Document ID 0676, Tables 1-2). Beginning in 1999, all new employees
were required to wear loose-fitting PAPRs in manufacturing buildings.
Skin protection became part of the protection program for new employees
in 2000, and glove use was required in production areas and for
handling work boots beginning in 2001. By 2001, either half-mask
respirators or PAPRs were required throughout the production facility
(type determined by airborne beryllium levels) and respiratory
protection was required for roof work and during removal of work boots
(Bailey et al., 2010).
Beginning in 2000, newly hired workers were offered periodic BeLPT
testing to evaluate the effectiveness of the new exposure control
program implemented by the company (Bailey et al., 2010). Bailey et al.
compared the occurrence of beryllium sensitization and disease among
258 employees who began work at the Elmore plant between January 15,
1993 and August 9, 1999 (the "pre-program group") with that of 290
employees who were hired between February 21, 2000 and December 18,
2006, and were tested at least once after hire (the "program group").
They found that, as of 1999, 23 (8.9 percent) of the pre-program group
were sensitized to beryllium. Six (2.1 percent) of the program group
had confirmed abnormal results on their final round of BeLPTs, which
occurred in different years for different employees. This four-fold
reduction in sensitization suggests that beryllium-exposed workers'
risk of sensitization (and therefore of CBD, which develops only
following sensitization) can be much reduced by the combination of
process controls, respiratory protection requirements, and PPE
requirements applied in this facility. Because most of the workers in
the study had been employed at the facility for less than two years,
and CBD typically develops over a longer period of time (see section V,
Health Effects), Bailey et al. did not report the incidence of CBD
among the sensitized workers (Bailey et al., 2010). Schuler et al.
(2012, Document ID 0473) published a study examining beryllium
sensitization and CBD among short-term workers at the Elmore, OH plant,
using exposure estimates created by Virji et al. (2012, Document ID
0466). The study population included 264 workers employed in 1999 with
up to 6 years tenure at the plant (91 percent of the 291 eligible
workers). By including only short-term workers, Virji et al. were able
to construct participants' exposures with more precision than was
possible in studies involving workers exposed for longer durations and
in time periods with less exposure sampling. A set of 1999 exposure
surveys and employee work histories was used to estimate employees'
long-term lifetime weighted (LTW) average, cumulative, and highest-job-
worked exposures for total, respirable, and submicron beryllium mass
concentrations (Schuler et al., 2012; Virji et al., 2012).
As reported by Schuler et al. (2012), the overall prevalence of
sensitization was 9.8 percent (26/264). Sensitized workers were offered
further evaluation for CBD. Twenty-two sensitized workers consented to
clinical testing for CBD via transbronchial biopsy. Although follow-up
time was too short (at most 6 years) to fully evaluate CBD in this
group, 6 of those sensitized were diagnosed with CBD (2.3 percent, 6/
264). Schuler et al. (2012) found 17 cases of sensitization (8.6%)
within the first 3 quartiles of LTW average exposure (198 workers with
LTW average total mass exposures lower than 1.1 µg/m3\) and 4
cases of CBD (2.2%) within those first 3 quartiles (183 workers with
LTW average total mass exposures lower than 1.07 µg/m3\)\12\ The
authors found 3 cases (4.6%) of sensitization among 66 workers with
total mass LTW average exposures below 0.1 µg/m3\, and no cases
of sensitization among workers with total mass LTW average exposures
below 0.09 µg/m3\, suggesting that beryllium-exposed workers'
risk can be much reduced or eliminated by reducing airborne exposures
to average levels below 0.1 µg/m3\.
---------------------------------------------------------------------------
\12\ The total number of workers Schuler et al. reported in
their table of LTW average quartiles for sensitization differs from
the total number of workers reported in their table of LTW average
quartiles for CBD. The table for CBD appeared to exclude 20 workers
with sensitization and no CBD.
---------------------------------------------------------------------------
Schuler et al. (2012, Document ID 0473) then used logistic
regression to explore the relationship between estimated beryllium
exposure and sensitization and CBD. For beryllium sensitization, the
logistic models by Schuler et al. showed elevated odds ratios (OR) for
LTW average (OR 1.48) and highest job (OR 1.37) exposure for total mass
exposure; the OR for cumulative exposure was smaller (OR 1.23) and
borderline statistically significant (95 percent CI barely included
unity).\13\ Relationships between sensitization and respirable exposure
estimates were similarly elevated for LTW average (OR 1.37) and highest
job (OR 1.32) exposures. Among the submicron exposure estimates, only
highest job (OR 1.24) had a 95 percent CI that just included unity for
sensitization. For CBD, elevated odds ratios were observed only for the
cumulative exposure estimates and were similar for total mass and
respirable exposure (total mass OR 1.66, respirable OR 1.68).
Cumulative submicron exposure showed an elevated, borderline
significant odds ratio (OR 1.58). The odds ratios for average exposure
and highest-exposed job were not statistically significantly elevated.
Schuler et al. concluded that both total and respirable mass
concentrations of beryllium exposure were relevant predictors of risk
for beryllium sensitization and CBD. Average and highest job exposures
were predictive of risk for sensitization, while cumulative exposure
was predictive of risk for CBD (Schuler et al., 2012).
---------------------------------------------------------------------------
\13\ An odds ratio (OR) is a measure of association between an
exposure and an outcome. The OR represents the odds that an outcome
will occur given a particular exposure, compared to the odds of the
outcome occurring in the absence of that exposure.
---------------------------------------------------------------------------
Materion submitted comments supporting OSHA's use of the Schuler et
al. (2012) study as a basis for the final TWA PEL of 0.2 µg/m3\.
Materion stated that "the best available evidence to establish a risk-
based OEL [occupational exposure limit] is the study conducted by NIOSH
and presented in Schuler 2012. The exposure assessment in
Schuler et al. was based on a highly robust workplace monitoring
dataset and the study provides improved data for determining OELs"
(Document ID 1661, pp. 9-10). Materion also submitted an unpublished
manuscript documenting an analysis it commissioned, entitled "Derived
No-Effect Levels for Occupational Beryllium Exposure Using Cluster
Analysis and Benchmark Dose Modeling" (Proctor et al., Document ID
1661, Attachment 5). In this document, Proctor et al. used data from
Schuler et al. 2012 to develop a Derived No-Effect Level (DNEL) for
beryllium measured as respirable beryllium, total mass of beryllium,
and inhalable beryllium.\14\ OSHA's beryllium standard measures
beryllium as total mass; thus, the results for total mass are most
relevant to OSHA's risk analysis for the beryllium standard. The
assessment reported a DNEL of 0.14 µg/m3\ for total mass
beryllium (Document ID 1661, Attachment 5, p. 16). Materion commented
that this finding "add[s] to the body of evidence that supports the
fact that OSHA is justified in lowering the existing PEL to 0.2
µg/m3\" (Document ID 1661, p. 11).
---------------------------------------------------------------------------
\14\ Derived No-Effect Level (DNEL) is used in REACH
quantitative risk characterizations to mean the level of exposure
above which humans should not be exposed. It is intended to
represent a safe level of exposure for humans., REACH is the
European Union's regulation on Registration, Evaluation,
Authorization and Restriction of Chemicals.
---------------------------------------------------------------------------
Proctor et al. characterized the DNEL of 0.14 µg/m3\ as
"inherently conservative because average exposure metrics were used to
determine DNELs, which are limits not [to] be exceeded on a daily
basis" (Document ID 1661, Attachment 5, p. 22). Materion referred to
the DNELs derived by Proctor et al. as providing an "additional margin
of safety" for similar reasons (Document ID 1661, p. 11).
Consistent with NIOSH comments discussed in the next paragraph,
OSHA disagrees with this characterization of the DNEL as representing a
"no effect level" for CBD or as providing a margin of safety for
several reasons. The DNEL from Proctor et al. is based on CBD findings
among a short-term worker population and thus cannot represent the risk
presented to workers who are exposed over a working lifetime. Proctor
et al. noted that it is "important to consider that these data are
from relatively short-term exposures [median tenure 20.9 months] and
are being used to support DNELs for lifetime occupational exposures,"
but considered the duration of exposure to be sufficient because "CBD
can develop with latency as short as 3 months of exposure, and . . .
the risk of CBD declines over time" (Document ID 1661, Attachment 5,
p. 19). In stating this, Procter et al. cite studies by Newman et al.
(2001, Document ID 1354) and Harber et al. (2009, as cited in Document
ID 1661). Newman et al. (2001) studied a group of workers in a
machining plant with job tenures averaging 11.7 years, considerably
longer than the worker cohort from the study used by Procter et al.,
and identified new cases of CBD from health screenings conducted up to
4 years after an initial screening. Harber et al., (2009) developed an
analytic model of disease progression from beryllium exposure and found
that, although the rate at which new cases of CBD declined over time,
the overall proportion of individuals with CBD increased over time from
initial exposure (see Figure 2 of Haber et al., 2009). Furthermore, the
study used by Proctor et al. to derive the DNEL, Schuler et al. (2012),
did report finding that the risk of CBD increased with cumulative
exposure to beryllium, as summarized above. Therefore, OSHA is not
convinced that a "no effect level" for beryllium that is based on the
health experience of workers with a median job tenure of 20.9 months
can represent a "no-effect level" for workers exposed to beryllium
for as long as 45 years.
NIOSH commented on the results of Proctor et al.'s analysis and the
underlying data set, noting several features of the dataset that are
common to the beryllium literature, such as uncertain date of
sensitization or onset of CBD and no "background" rate of beryllium
sensitization or CBD, that make statistical analyses of the data
difficult and add uncertainty to the derivation of a DNEL (Document ID
1725, p. 5). NIOSH also noted that risk of CBD may be underestimated in
the underlying data set if workers with CBD were leaving employment
due, in part, to adverse health effects ("unmeasured survivor bias")
and estimated that as much as 30 percent of the cohort could have been
lost over the 6-year testing period (Document ID 1725, p. 5). NIOSH
concluded that Proctor et al.'s analysis "does not contribute to the
risk assessment for beryllium workers" (Document ID 1725, p. 5). OSHA
agrees with NIOSH that the DNEL identified by Proctor et al. cannot be
considered a reliable estimate of a no-effect level for beryllium.
4. Cullman, AL, Plant
Newman et al. (2001, Document ID 1354), Kelleher et al. (2001,
Document ID 1363), and Madl et al. (2007, Document ID 1056) studied
beryllium workers at a precision machining facility in Cullman,
Alabama. After a case of CBD was diagnosed at the plant in 1995, the
company began BeLPT screenings to identify workers at risk of CBD and
implemented engineering and administrative controls designed to reduce
workers' beryllium exposures in machining operations. Newman et al.
(2001) conducted a series of BeLPT screenings of workers at the
facility between 1995 and 1999. The authors reported 22 (9.4 percent)
sensitized workers among 235 tested, 13 of whom were diagnosed with CBD
within the study period. Personal lapel samples collected between 1980
and 1999 indicate that median exposures were generally well below the
preceding PEL (<=0.35 µg/m3\ in all job titles except
maintenance (median 3.1 µg/m3\ during 1980-1995) and gas
bearings (1.05 µg/m3\ during 1980-1995)).
Between 1995 and 1999, the company built enclosures around several
beryllium-releasing operations; installed or updated LEV for several
machining departments; replaced pressurized air hoses and dry sweeping
with wet methods and vacuum systems for cleaning; changed the layout of
the plant to keep beryllium-releasing processes close together; limited
access to the production area of the plant; and required the use of
company uniforms. Madl et al. (2007, Document ID 1056) reported that
engineering and work process controls, rather than personal protective
equipment, were used to limit workers' exposure to beryllium. In
contrast to the Reading and Tucson plants, gloves were not required at
this plant. Personal lapel samples collected extensively between 1996
and 1999 in machining and non-machining jobs had medians of 0.16
µg/m3\ and 0.08 µg/m3\, respectively (Madl et al., 2007,
Table IV). At the time that Newman et al. reviewed the results of BeLPT
screenings conducted in 1995-1999, a subset of 60 workers had been
employed at the plant for less than a year and had therefore benefitted
to some extent from the controls described above. Four (6.7 percent) of
these workers were found to be sensitized, of whom two were diagnosed
with CBD and one with probable CBD (Newman et al., 2001, Document ID
1354). The later study by Madl. et al. reported seven sensitized
workers who had been hired between 1995 and 1999, of whom four had
developed CBD as of 2005 (2007, Table II) (total number of workers
hired between 1995 and 1999 not reported).
Beginning in 2000 (after the implementation of controls between
1997 and 1999), exposures in all jobs at the machining facility were
reduced to
extremely low levels (Madl et al., 2007, Document ID 1056). Personal
lapel samples collected between 2000 and 2005 had a median of 0.12
µg/m3\ or less in all machining and non-machining processes
(Madl. et al., 2007, Table IV). Only one worker hired after 1999 became
sensitized (Madl et al. 2007, Table II). The worker had been employed
for 2.7 years in chemical finishing, which had the highest median
exposure of 0.12 µg/m3\ (medians for other processes ranged from
0.02 to 0.11 µg/m3\); Madl et al. 2007, Table II). This result
from Madl et al. (2007) suggests that beryllium-exposed workers' risk
of sensitization can be much reduced by steps taken to reduce workers'
airborne exposures in this facility, including enclosure of beryllium-
releasing processes, LEV, wet methods and vacuum systems for cleaning,
and limiting worker access to production areas.
The Cullman, AL facility was also the subject of a case-control
study published by Kelleher et al. in 2001 (Document ID 1363). After
the diagnosis of a case of CBD at the plant in 1995, NJH researchers,
including Kelleher, worked with the plant to conduct the medical
surveillance program mentioned above, using the BeLPT to screen workers
biennially for beryllium sensitization and offering sensitized workers
further evaluation for CBD (Kelleher et al., 2001). Concurrently,
research was underway by Martyny et al. to characterize the particle
size distribution of beryllium exposures generated by processes at this
plant (Martyny et al., 2000, Document ID 1358). Kelleher et al. used
the dataset of 100 personal lapel samples collected by Martyny et al.
and other NJH researchers to characterize exposures for each job in the
plant. Detailed work history information gathered from plant data and
worker interviews was used in combination with job exposure estimates
to characterize cumulative and LTW average beryllium exposures for
workers in the surveillance program. In addition to cumulative and LTW
average exposure estimates based on the total mass of beryllium
reported in their exposure samples, Kelleher et al. calculated
cumulative and LTW average estimates based specifically on exposure to
particles <6 μm and particles <1 μm in diameter. To analyze the
relationship between exposure level and risk of sensitization and CBD,
Kelleher et al. performed a case-control analysis using measures of
both total beryllium exposure and particle size-fractionated exposure.
The results, however, were inconclusive, probably due to the relatively
small size of the dataset (Kelleher et al., 2001).
5. Aluminum Smelting Plants
Taiwo et al. (2008, Document ID 0621; 2010 (0583) and Nilsen et al.
(2010, Document ID 0460) studied the relationship between beryllium
exposure and adverse health effects among workers at aluminum smelting
plants. Taiwo et al. (2008) studied a population of 734 employees at 4
aluminum smelters located in Canada (2), Italy (1), and the United
States (1). In 2000, a company-wide beryllium exposure limit of 0.2
μg/m3\ and an action level of 0.1 μg/m3\, expressed as 8-hour
TWAs, and a short-term exposure limit (STEL) of 1.0 μg/m3\ (15-
minute sample) were instituted at these plants. Sampling to determine
compliance with the exposure limit began at all four smelters in 2000.
Table VI-1 below, adapted from Taiwo et al. (2008), shows summary
information on samples collected from the start of sampling through
2005.
Table VI-1--Exposure Sampling Data By Plant--2000-2005
----------------------------------------------------------------------------------------------------------------
Arithmetic
Smelter Number samples Median (μg/ mean (μg/ Geometric mean
m3\) m3\) (μg/m3\)
----------------------------------------------------------------------------------------------------------------
Canadian smelter 1.............................. 246 0.03 0.09 0.03
Canadian smelter 2.............................. 329 0.11 0.29 0.08
Italian smelter................................. 44 0.12 0.14 0.10
US smelter...................................... 346 0.03 0.26 0.04
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2008, Document ID 0621, Table 1.
All employees potentially exposed to beryllium levels at or above
the action level for at least 12 days per year, or exposed at or above
the STEL 12 or more times per year, were offered medical surveillance,
including the BeLPT (Taiwo et al., 2008). Table VI-2 below, adapted
from Taiwo et al. (2008), shows test results for each facility between
2001 and 2005.
Table VI-2--BeLPT Results By Plant--2001-2005
----------------------------------------------------------------------------------------------------------------
Abnormal
Smelter Employees Normal BeLPT Confirmed
tested (unconfirmed) sensitized
----------------------------------------------------------------------------------------------------------------
Canadian smelter 1.............................. 109 107 1 1
Canadian smelter 2.............................. 291 290 1 0
Italian smelter................................. 64 63 0 1
US smelter...................................... 270 268 2 0
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2008, Document ID 0621, Table 2
The two workers with confirmed beryllium sensitization were offered
further evaluation for CBD. Both were diagnosed with CBD, based on
broncho-alveolar lavage (BAL) results in one case and pulmonary
function tests, respiratory symptoms, and radiographic evidence in the
other.
In 2010, Taiwo et al. (Document ID 0583) published a study of
beryllium-exposed workers from four companies, with a total of nine
smelting operations. These workers included some of the workers from
the 2008 study. 3,185 workers were determined to be "significantly
exposed" to beryllium and invited to participate in BeLPT screening.
Each company used different
criteria to determine "significant" exposure, and the criteria
appeared to vary considerably (Taiwo et al., 2010); thus, it is
difficult to compare rates of sensitization across companies in this
study. 1932 workers, about 60 percent of invited workers, participated
in the program between 2000 and 2006, of whom 9 were determined to be
sensitized (.4 percent). The authors stated that all nine workers were
referred to a respiratory physician for further evaluation for CBD. Two
were diagnosed with CBD (.1 percent), as described above (see Taiwo et
al., 2008).
In general, there appeared to be a low level of sensitization and
CBD among employees at the aluminum smelters studied by Taiwo et al.
(2008; 2010). This is striking in light of the fact that many of the
employees tested had worked at the smelters long before the institution
of exposure limits for beryllium at some smelters in 2000. However, the
authors noted that respiratory and dermal protection had been used at
these plants to protect workers from other hazards (Taiwo et al.,
2008).
A study by Nilsen et al. (2010, Document ID 0460) of aluminum
workers in Norway also found a low rate of sensitization. In the study,
362 workers and 31 control individuals received BeLPT testing for
beryllium sensitization. The authors found one sensitized worker (0.28
percent). No borderline results were reported. The authors reported
that exposure measurements in this plant ranged from 0.1 μg/m3\ to
0.31 μg/m3\ (Nilsen et al., 2010) and that respiratory protection
was in use, as was the case in the smelters studied by Taiwo et al.
(2008; 2010).
6. Nuclear Weapons Facilities
Viet et al. (2000, Document ID 1344) and Arjomandi et al. (2010,
Document ID 1275) evaluated beryllium-exposed nuclear weapons workers.
In 2000, Viet et al. published a case-control study of participants in
the Rocky Flats Beryllium Health Surveillance Program (BHSP), which was
established in 1991 to screen workers at the Department of Energy's
Rocky Flats, CO, nuclear weapons facility for beryllium sensitization
and evaluate sensitized workers for CBD. The program, which the authors
reported had tested over 5,000 current and former Rocky Flats employees
for sensitization, had identified a total of 127 sensitized individuals
as of 1994 when Viet et al. initiated their study; 51 of these
sensitized individuals had been diagnosed with CBD.
Using subjects from the BHSP, Viet et al. (2000) matched a total of
50 CBD cases to 50 controls who tested negative for beryllium
sensitization and had the same age ( 3 years), gender, race
and smoking status, and were otherwise randomly selected from the
database. Using the same matching criteria, 74 sensitized workers who
were not diagnosed with CBD were matched to 74 control individuals from
the BHSP database who tested negative for beryllium sensitization.
Viet et al. (2000) developed exposure estimates for the cases and
controls based on daily fixed airhead (FAH) beryllium air samples
collected in one of 36 buildings at Rocky Flats where beryllium was
used, the Building 444 Beryllium Machine Shop. Annual mean FAH samples
in Building 444 collected between 1960 and 1988 ranged from a low of
0.096 μg/m3\ (1988) to a high of 0.622 μg/m3\ (1964) (Viet et
al., 2000, Table II). Because exposures in this shop were better
characterized than in other buildings, the authors developed estimates
of exposures for all workers based on samples from Building 444. The
authors' statistical analysis of the resulting data set included
conditional logistic regression analysis, modeling the relationship
between risk of each health outcome and individuals' log-transformed
cumulative exposure estimate (CEE) and mean exposure estimate (MEE).
These coefficients corresponded to odds ratios of 6.9 and 7.2 per 10-
fold increase in exposure, respectively. Risk of sensitization without
CBD did not show a statistically significant relationship with log-CEE
(coef = 0.111, p = 0.32), but showed a nearly-significant relationship
with log-MEE (coef = 0.230, p = 0.097). Viet et al. found highly
statistically significant relationships between log-CEE and risk of CBD
(coef = 0.837, p = 0.0006) and between log-MEE (coef = 0.855, p =
0.0012) and risk of CBD, indicating that risk of CBD increases with
exposure level.
Arjomandi et al. (2010) published a study of 50 sensitized workers
from a nuclear weapons research and development facility who were
evaluated for CBD. Quantitative exposure estimates for the workers were
not presented; however, the authors characterized their likely
exposures as low (possibly below 0.1 μg/m3\ for most jobs). In
contrast to the studies of low-exposure populations discussed
previously, this group had much longer follow-up time (mean time since
first exposure = 32 years) and length of employment at the facility
(mean of 18 years).
Five of the 50 evaluated workers (10 percent) were diagnosed with
CBD based on histology or high-resolution computed tomography. An
additional three (who had not undergone full clinical evaluation for
CBD) were identified as probable CBD cases, bringing the total
prevalence of CBD and probable CBD in this group to 16 percent. OSHA
notes that this prevalence of CBD among sensitized workers is lower
than the prevalence of CBD that has been observed in some other worker
groups known to have exposures exceeding the action level of 0.1 μg/
m3\. For example, as discussed above, Newman et al. (2001, Document ID
1354) reported 22 sensitized workers, 13 of whom (59 percent) were
diagnosed with CBD within the study period. Comparison of these results
suggests that controlling respiratory exposure to beryllium may reduce
risk of CBD among already-sensitized workers as well as reducing risk
of CBD via prevention of sensitization. However, it also demonstrates
that some workers in low-exposure environments can become sensitized
and then develop CBD.
7. Conclusions
The published literature on beryllium sensitization and CBD
discussed above shows that risk of both health effects can be
significant in workplaces in compliance with OSHA's preceding PEL
(e.g., Kreiss et al., 1996, Document ID 1477; Henneberger et al., 2001
(1313); Newman et al., 2001 (1354); Schuler et al., 2005 (0919), 2012
(0473); Madl et al., 2007 (1056)). For example, in the Tucson beryllia
ceramics plant discussed above, Kreiss et al. (1996) reported that 8
(5.9 percent) of the 136 workers tested in 1992 were sensitized, 6 (4.4
percent) of whom were diagnosed with CBD. In addition, of 77 Tucson
workers hired prior to 1992 who were tested in 1998, 8 (10.4 percent)
were sensitized and 7 of these (9.7 percent) were diagnosed with CBD
(Henneberger et al., 2001, Document ID 1313). Full-shift area samples
showed airborne beryllium levels below the preceding PEL (76 percent of
area samples collected between 1983 and 1992 were at or below 0.1
μg/m3\ and less than 1 percent exceeded 2 μg/m3\; short-term
breathing zone measurements collected between 1981 and 1992 had a
median of 0.3 μg/m3\; personal lapel samples collected at the plant
beginning in 1991 had a median of 0.2 μg/m3\) (Kreiss et al.,
1996).
Results from the Elmore, OH beryllium metal, alloy, and oxide
production plant and Cullman, AL machining facility also showed
significant risk of sensitization and CBD
among workers with exposures below the preceding TWA PEL. Schuler et
al. (2012, Document ID 0473) found 17 cases of sensitization (8.6%)
among Elmore, OH workers within the first three quartiles of LTW
average exposure (198 workers with LTW average total mass exposures
lower than 1.1 μg/m3\) and 4 cases of CBD (2.2%) within the first
three quartiles of LTW average exposure (183 workers with LTW average
total mass exposures lower than 1.07 μg/m3\; note that follow-up
time of up to 6 years for all study participants was very short for
development of CBD). At the Cullman, AL machining facility, Newman et
al. (2001, Document ID 1354) reported 22 (9.4 percent) sensitized
workers among 235 tested in 1995-1999, 13 of whom were diagnosed with
CBD. Personal lapel samples collected between 1980 and 1999 indicate
that median exposures were generally well below the preceding PEL
(<=0.35 μg/m3\ in all job titles except maintenance (median 3.1
μg/m3\ during 1980-1995) and gas bearings (1.05 μg/m3\ during
1980-1995)).
There is evidence in the literature that although risk will be
reduced by compliance with the new TWA PEL, significant risk of
sensitization and CBD will remain in workplaces in compliance with
OSHA's new TWA PEL of 0.2 μg/m3\ and could extend down to the new
action level of 0.1 μg/m3\, although there is less information and
therefore greater uncertainty with respect to significant risk from
airborne beryllium exposures at and below the action level. For
example, Schuler et al. (2005, Document ID 0919) reported substantial
prevalences of sensitization (6.5 percent) and CBD (3.9 percent) among
152 workers at the Reading, PA facility who had BeLPT screening in
2000. These results showed significant risk at this facility, even
though airborne exposures were primarily below both the preceding and
final TWA PELs due to the low percentage of beryllium in the metal
alloys used (median general area samples <=0.1 μg/m3\, 97% <=0.5
μg/m3\); 93% of personal lapel samples were below the new TWA PEL
of 0.2 μg/m3\). The only group of workers with no cases of
sensitization or CBD, a group of 26 office administration workers, was
the group with exposures below the new action level of 0.1 μg/m3\
(median personal sample 0.01 μg/m3\, range <0.01-0.06 μg/m3\
(Schuler et al., 2005). The Schuler et al. (2012, Document ID 0473)
study of short-term workers in the Elmore, OH facility found 3 cases
(4.6%) of sensitization among 66 workers with total mass LTW average
exposures below 0.1 μg/m3\; 3 of these workers had LTW average
exposures of approximately 0.09 μg/m3\.
Furthermore, cases of sensitization and CBD continued to arise in
the Cullman, AL machining plant after control measures implemented
beginning in 1995 brought median airborne exposures below 0.2 μg/
m3\ (personal lapel samples between 1996 and 1999 in machining jobs
had a median of 0.16 μg/m3\ and 0.08 μg/m3\ in non-machining
jobs) (Madl et al., 2007, Document ID 1056, Table IV). At the time that
Newman et al. (2001, Document ID 1354) reviewed the results of BeLPT
screenings conducted in 1995-1999, a subset of 60 workers had been
employed at the plant for less than a year and had therefore benefitted
to some extent from the exposure reductions. Four (6.7 percent) of
these workers were found to be sensitized, two of whom were diagnosed
with CBD and one with probable CBD (Newman et al., 2001). A later study
by Madl. et al. (2007, Document ID 1056) reported seven sensitized
workers who had been hired between 1995 and 1999, of whom four had
developed CBD as of 2005 (Table II; total number of workers hired
between 1995 and 1999 not reported).
The experiences of several facilities in developing effective
industrial hygiene programs have shown the importance of minimizing
both airborne exposure and dermal contact to effectively reduce risk of
sensitization and CBD. Exposure control programs that have used a
combination of engineering controls and PPE to reduce workers' airborne
exposure and dermal contact have substantially lowered risk of
sensitization among newly hired workers.\15\ Of 97 workers hired
between 2000 and 2004 in the Tucson, AZ plant after the introduction of
mandatory respirator use in production areas beginning in 1999 and
mandatory use of latex gloves beginning in 2000, one case of
sensitization was identified (1 percent) (Cummings et al., 2007,
Document ID 1369). In Elmore, OH, where all workers were required to
wear respirators and skin PPE in production areas beginning in 2000-
2001, the estimated prevalence of sensitization among workers hired
after these measures were put in place was around 2 percent (Bailey et
al., 2010, Document ID 0676). In the Reading, PA facility, only one
(2.2 percent) of 45 workers hired after workers' exposures were reduced
to below 0.1 μg/m3\ and PPE to prevent dermal contact was
instituted was sensitized (Thomas et al., 2009, Document ID 0590). And,
in the aluminum smelters discussed by Taiwo et al. (2008, Document ID
0621), where available exposure samples from four plants indicated
median beryllium levels of about 0.1 μg/m3\ or below (measured as
an 8-hour TWA) and workers used respiratory and dermal protection,
confirmed cases of sensitization were rare (zero or one case per
location).
---------------------------------------------------------------------------
\15\ As discussed in Section V, Health Effects, beryllium
sensitization can occur from dermal contact with beryllium. Studies
conducted in the 1950s by Curtis et al. showed that soluble
beryllium particles could cause beryllium hypersensitivity (Curtis,
1951, Document ID 1273; NAS, 2008, Document ID 1355). Tinkle et al.
established that 0.5- and 1.0-μm particles can penetrate intact
human skin surface and reach the epidermis, where beryllium
particles would encounter antigen-presenting cells and initiate
sensitization (Tinkle et al., 2003, Document ID 1483). Tinkle et al.
further demonstrated that beryllium oxide and beryllium sulfate,
applied to the skin of mice, generate a beryllium-specific, cell-
mediated immune response similar to human beryllium sensitization.
---------------------------------------------------------------------------
OSHA recognizes that the studies on recent programs to reduce
workers' risk of sensitization and CBD were conducted on populations
with very short exposure and follow-up time. Therefore, they could not
adequately address the question of how frequently workers who become
sensitized in environments with extremely low airborne exposures
(median <0.1 μg/m3\) develop CBD. Clinical evaluation for CBD was
not reported for sensitized workers identified in the studies examining
the post-2000, very low-exposed worker cohorts in Tucson, Reading, and
Elmore (Cummings et al. 2007, Document ID 1369; Thomas et al. 2009
(0590); Bailey et al. 2010 (0676)). In Cullman, however, two of the
workers with CBD had been employed for less than a year and worked in
jobs with very low exposures (median 8-hour personal sample values of
0.03-0.09 μg/m3\) (Madl et al., 2007, Document ID 1056, Table III).
The body of scientific literature on occupational beryllium disease
also includes case reports of workers with CBD who are known or
believed to have experienced minimal beryllium exposure, such as a
worker employed only in shipping at a copper-beryllium distribution
center (Stanton et al., 2006, Document ID 1070), and workers employed
only in administration at a beryllium ceramics facility (Kreiss et al.,
1996, Document ID 1477). Therefore, there is some evidence that cases
of CBD can occur in work environments where beryllium exposures are
quite low.
8. Community-Acquired CBD
In the NPRM, OSHA discussed an additional source of information on
low-level beryllium exposure and CBD: Studies of community-acquired
chronic beryllium disease (CA-CBD) in residential areas surrounding
beryllium
production facilities. The literature on CA-CBD, including the Eisenbud
(1949, Document ID 1284), Leiben and Metzner (1959, Document ID 1343),
and Maier et al. (2008, Document ID 0598) studies, documents cases of
CBD among individuals exposed to airborne beryllium at concentrations
below the new PEL. OSHA included a review of these studies in the NPRM
as a secondary source of information on risk of CBD from low-level
beryllium exposure. However, the available studies of CA-CBD have
important limitations. These case studies do not provide information on
how frequently individuals exposed to very low airborne levels develop
CBD. In addition, the reconstructed exposure estimates for CA-CBD cases
are less reliable than the exposure estimates for working populations
reviewed in the previous sections. The literature on CA-CBD therefore
was not used by OSHA as a basis for its quantitative risk assessment
for CBD, and the Agency did not receive any comments or testimony on
this literature. Nevertheless, these case reports and the broader CA-
CBD literature indicate that individuals exposed to airborne beryllium
below the final TWA PEL can develop CBD (e.g., Leiben and Metzner,
1959; Maier et al., 2008).
B. OSHA's Prevalence Analysis for Sensitization and CBD
OSHA evaluated exposure and health outcome data on a population of
workers employed at the Cullman machining facility as one part of the
Agency's Preliminary Risk Analysis presented in the NPRM. A summary of
OSHA's preliminary analyses of these data, a discussion of comments
received on the analyses and OSHA's responses to these comments, as
well as a summary OSHA's final quantitative analyses, are presented in
the remainder of this section. A more detailed discussion of the data,
background information on the facility, and OSHA's analyses appears in
the background document OSHA has placed in the record (Risk Analysis of
the NJH Data Set from the Beryllium Machining Facility in Cullman,
Alabama--CBD and Sensitization, OSHA, 2016).
NJH researchers, with consent and information provided by the
Cullman facility, compiled a dataset containing employee work
histories, medical diagnoses, and air sampling results and provided it
to OSHA for analysis. OSHA's contractors from Eastern Research Group
(ERG) gathered additional information about work operations and
conditions at the plant, developed exposure estimates for individual
workers in the dataset, and helped to conduct quantitative analyses of
the data to inform OSHA's risk assessment (Document ID tbd).
1. Worker Exposure Reconstruction
The work history database contains job history records for 348
workers. ERG calculated cumulative and average exposure estimates for
each worker in the database. Cumulative exposure was calculated as,
[GRAPHIC] [TIFF OMITTED] TR09JA17.003
where e(i) is the exposure level for job (i), and t(i) is the time
spent in job (i). Cumulative exposure was divided by total exposure
time to estimate each worker's long-term average exposure. These
exposures were computed in a time-dependent manner for the statistical
modeling.\16\ For workers with beryllium sensitization or CBD, exposure
estimates excluded exposures following diagnosis.
---------------------------------------------------------------------------
\16\ Each worker's exposure was calculated at each time that
BeLPT testing was conducted.
---------------------------------------------------------------------------
Workers who were employed for long time periods in jobs with low-
level exposures tend to have low average and cumulative exposures due
to the way these measures are constructed, incorporating the worker's
entire work history. As discussed in the Health Effects chapter,
higher-level exposures or short-term peak exposures such as those
encountered in machining jobs may be highly relevant to risk of
sensitization. However, individuals' beryllium exposure levels and
sensitization status are not continuously monitored, so it is not known
exactly when workers became sensitized or what their "true" peak
exposures leading up to sensitization were. Only a rough approximation
of the upper levels of exposure a worker experienced is possible. ERG
attempted to represent workers' highest exposures by constructing a
third type of exposure estimate reflecting the exposure level
associated with the highest-exposure job (HEJ) and time period
experienced by each worker. This exposure estimate (HEJ), the
cumulative exposure estimate, and the average exposure were used in the
quartile analysis and statistical analyses presented below.
2. Prevalence of Sensitization and CBD
In the database provided to OSHA, 7 workers were reported as
sensitized only (that is, sensitized with no known development of CBD).
Sixteen workers were listed as sensitized and diagnosed with CBD upon
initial clinical evaluation. Three workers, first shown to be
sensitized only, were later diagnosed with CBD. Tables VI-3, VI-4, and
VI-5 below present the prevalence of sensitization and CBD cases across
several categories of LTW average, cumulative, and HEJ exposure.
Exposure values were grouped by quartile. For this analysis, OSHA
excluded 8 workers with no job title listed in the data set (because
their exposures could not be estimated); 7 workers whose date of hire
was before 1969 (because this indicates they worked in the company's
previous plant, for which no exposure measurements were available); and
14 workers who had zero exposure time in the data set, perhaps
indicating that they had been hired but had not come to work at
Cullman. After these exclusions, a total of 319 workers remained. None
of the excluded workers were identified as having beryllium
sensitization or CBD.
Note that all workers with CBD are also sensitized. Thus, the
columns "Total Sensitized" and "Total %" refer to all sensitized
workers in the dataset, including workers with and without a diagnosis
of CBD.
Table VI-3--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized Total
LTW average exposure (μg/m3\) Group size only CBD sensitized Total (%) CBD (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080............................................... 91 1 1 2 2.2 1.0
0.081-0.18.............................................. 73 2 4 6 8.2 5.5
0.19-0.51............................................... 77 0 6 6 7.8 7.8
0.51-2.15............................................... 78 4 8 12 15.4 10.3
=================
=================
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-4--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized Total
Cumulative exposure (μg/m3\-yrs) Group size only CBD sensitized Total (%) CBD (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147............................................... 81 2 2 4 4.9 2.5
0.148-1.467............................................. 79 0 2 2 2.5 2.5
1.468-7.008............................................. 79 3 8 11 13.9 8.0
7.009-61.86............................................. 80 2 7 9 11.3 8.8
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2% 6.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-5--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized Total
HEJ exposure (μg/m3\) Group size only CBD sensitized Total (%) CBD (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086............................................... 86 1 0 1 1.2 0.0
0.091-0.214............................................. 81 1 6 7 8.6 7.4
0.387-0.691............................................. 76 2 9 11 14.5 11.8
0.954-2.213............................................. 76 3 4 7 9.2 5.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-3 shows increasing prevalence of total sensitization and
CBD with increasing LTW average exposure. The lowest prevalence of
sensitization and CBD was observed among workers with average exposure
levels less than or equal to 0.08 μg/m3\, where two sensitized
workers (2.2 percent), including one case of CBD (1.0 percent), were
found. The sensitized worker in this category without CBD had worked at
the facility as an inspector since 1972, one of the lowest-exposed jobs
at the plant. Because the job was believed to have very low exposures,
it was not sampled prior to 1998. Thus, estimates of exposures in this
job are based on data from 1998-2003 only. It is possible that
exposures earlier in this worker's employment history were somewhat
higher than reflected in his estimated average exposure. The worker
diagnosed with CBD in this group had been hired in 1996 in production
control, and had an estimated average exposure of 0.08 μg/m3\. This
worker was diagnosed with CBD in 1997.
The second quartile of LTW average exposure (0.081-0.18 μg/m3\)
shows a marked rise in overall prevalence of beryllium-related health
effects, with 6 workers sensitized (8.2 percent), of whom 4 (5.5
percent) were diagnosed with CBD. Among 6 sensitized workers in the
third quartile (0.19-0.51 μg/m3\), all were diagnosed with CBD (7.8
percent). Another increase in prevalence is seen from the third to the
fourth quartile, with 12 cases of sensitization (15.4 percent),
including eight (10.3 percent) diagnosed with CBD.
The quartile analysis of cumulative exposure also shows generally
increasing prevalence of sensitization and CBD with increasing
exposure. As shown in Table VI-4, the lowest prevalences of CBD and
sensitization are in the first two quartiles of cumulative exposure
(0.0-0.147 μg/m3\-yrs, 0.148-1.467 μg/m3\-yrs). The upper bound
on this cumulative exposure range, 1.467 μg/m3\-yrs, is the
cumulative exposure that a worker would have if exposed to beryllium at
a level of 0.03 μg/m3\ for a working lifetime of 45 years; 0.15
μg/m3\ for ten years; or 0.3 μg/m3\ for five years. These
exposure levels are in the range of those OSHA was interested in
evaluating for purposes of this rulemaking.
A sharp increase in prevalence of sensitization and CBD occurs in
the third quartile (1.468-7.008 μg/m3\-yrs), with roughly similar
levels of both in the highest group (7.009-61.86 μg/m3\-yrs).
Cumulative exposures in the third quartile would be experienced by a
worker exposed for 45 years to levels between 0.03 and 0.16 μg/m3\,
for 10 years to levels between 0.15 and 0.7 μg/m3\, or for 5 years
to levels between 0.3 and 1.4 μg/m3\.
When workers' exposures from their highest-exposed job are
considered, the exposure-response pattern is similar to that for LTW
average exposure in the lower quartiles. In Table VI-5, the lowest
prevalence is observed in the first quartile (0.0-0.086 μg/m3\),
with sharply rising prevalence from first to second and second to third
exposure quartiles. The prevalence of sensitization and CBD in the top
quartile (0.954-2.213 μg/m3\) decreases relative to the third, with
levels similar to the overall prevalence in the dataset. Many workers
in the highest exposure quartiles are long-time employees, who were
hired during the early years of the shop when exposures were highest.
One possible explanation for the drop in prevalence in the highest
exposure quartiles is that other highly-exposed workers from early
periods may have developed CBD and left the plant before sensitization
testing began in 1995 (i.e., the healthy worker survivor effect).
The results of this prevalence analysis support OSHA's conclusion
that maintaining exposure levels below the new TWA PEL will help to
reduce risk
of beryllium sensitization and CBD, and that maintaining exposure
levels below the action level can further reduce risk of beryllium
sensitization and CBD. However, risk of both sensitization and CBD
remains even among the workers with the lowest airborne exposures in
this data set.
C. OSHA's Statistical Modeling for Sensitization and CBD
1. OSHA's Preliminary Analysis of the NJH Data Set
In the course of OSHA's development of the proposed rule, OSHA's
contractor (ERG) also developed a statistical analysis using the NJH
data set and a discrete time proportional hazards analysis (DTPHA).
This preliminary analysis predicted significant risks of both
sensitization (96-394 cases per 1,000, or 9.6-39.4 percent) and CBD
(44-313 cases per 1,000, or 4.4-31.3 percent) at the preceding TWA PEL
of 2 μg/m3\ for an exposure duration of 45 years (90 μg/m3\-
yr). The predicted risks of 8.2-39.9 cases of sensitization per 1,000
(0.8-3.9 percent) and 3.6 to 30.0 cases of CBD per 1,000 (0.4-3
percent) were approximately 10-fold less, but still significant, for a
45-year exposure at the new TWA PEL of 0.2 μg/m3\ (9 μg/m3\-
yr).
In interpreting the risk estimates, OSHA took into consideration
limitations in the preliminary statistical analysis, primarily study
size-related constraints. Consequently, as discussed in the NPRM, OSHA
did not rely on the preliminary statistical analysis for its
significance of risk determination or to develop its benefits analysis.
The Agency relied primarily on the previously-presented analysis of the
epidemiological literature and the prevalence analysis of the Cullman
data for its preliminary significance of risk determination, and on the
prevalence analysis for its preliminary estimate of benefits. Although
OSHA did not rely on the results of the preliminary statistical
analysis for its findings, the Agency presented the DTPHA in order to
inform the public of its results, explain its limitations, and solicit
public comment on the Agency's approach.
Dr. Kenny Crump and Ms. Deborah Proctor submitted comments on
OSHA's preliminary risk assessment (Document ID 1660). Crump and
Proctor agreed with OSHA's review of the epidemiological literature and
the prevalence analysis presented previously in this section. They
stated, "we agree with OSHA's conclusion that there is a significant
risk (>1/1000 risk of CBD) at the [then] current PEL, and that risk is
reduced at the [then] proposed PEL (0.2 μg/m3\) in combination with
stringent measures (ancillary provisions) to reduce worker's exposures.
This finding is evident based on the available literature, as described
by OSHA, and the prevalence data presented for the Cullman facility"
(Document ID 1660, p. 2). They also presented a detailed evaluation of
the statistical analysis of the Cullman data presented in the NPRM,
including a critique of OSHA's modeling approach and interpretation and
suggestions for alternate analyses. However, they emphasized that the
new beryllium rule should not be altered or delayed due to their
comments regarding the statistical model (Document ID 1660, p. 2).
After considering comments on this preliminary model, OSHA
instructed its contractor to change the statistical analysis to address
technical concerns and to incorporate suggestions from Crump and
Proctor, as well as NIOSH (Document ID 1660; 1725). OSHA reviews and
addresses these comments on the preliminary statistical analysis and
provides a presentation of the final statistical analysis in the
background document (Risk Analysis of the NJH Data Set from the
Beryllium Machining Facility in Cullman, Alabama--CBD and
Sensitization, OSHA, 2016). The results of the final statistical
analysis are summarized here.
2. OSHA's Final Statistical Analysis of the NJH Data Set
As noted above, Dr. Roslyn Stone of University of Pittsburgh School
of Public Health reanalyzed for OSHA the Cullman data set in order to
address concerns raised by Crump and Proctor (Document ID 1660). The
reanalysis uses a Cox proportional hazards model instead of the DTPHA.
The Cox model, a regression method for survival data, provides an
estimate of the hazard ratio (HR) and its confidence interval.\17\ Like
the DTPHA, the Cox model can accommodate time-dependent data; however,
the Cox model has an advantage over the DTPHA for OSHA's purpose of
estimating risk to beryllium-exposed workers in that it does not
estimate different "baseline" rates of sensitization and CBD for
different years. Time-specific risk sets were constructed to
accommodate the time-dependent exposures. P-values were based on
likelihood ratio tests (LRTs), with p-values <0.05 considered to be
statistically significant.
---------------------------------------------------------------------------
\17\ The hazard ratio is an estimate of the ratio of the hazard
rate in the exposed group to that of the control group.
---------------------------------------------------------------------------
As in the preliminary statistical analysis, Dr. Stone used
fractional polynomials \18\ to check for possible nonlinearities in the
exposure-response models, and checked the effects of age and smoking
habits using data on birth year and smoking (current, former, never)
provided in the Cullman data set. Data on workers' estimated exposures
and health outcomes through 2005 were included in the reanalysis.\19\
The 1995 risk set (e.g., analysis of cases of sensitization and CBD
identified in 1995) was excluded from all models in the reanalysis so
as not to analyze long-standing (prevalent) cases of sensitization and
CBD together with newly arising (incident) cases of sensitization and
CBD. Finally, Dr. Stone used the testing protocols provided in the
literature on the Cullman study population to determine the years in
which each employee was scheduled to be tested, and excluded employees
from the analysis for years in which they were not scheduled to be
tested (Newman et al., 2001, Document ID 1354).
---------------------------------------------------------------------------
\18\ Fractional polynomials are linear combinations of
polynomials that provide flexible shapes of exposure response.
\19\ Data from 2003 to 2005 were excluded in some previous
analyses due to uncertainty in some employees' work histories. OSHA
accepted the.Crump and Proctor recommendation that these data should
be included, so as to treat uncertain exposure estimates
consistently in the reanalysis (data prior to the start of sampling
in 1980 were included in the previous analysis and most models in
the reanalysis).
---------------------------------------------------------------------------
In the reanalysis of the NJH data set, the HR for sensitization
increased significantly with increasing LTW average exposure (HR =
2.92, 95% CI = 1.51-5.66, p = 0.001; note that HRs are rounded to the
second decimal place). Cumulative exposure was also a statistically
significant predictor for beryllium sensitization, although it was not
as strongly related to sensitization as LTW average exposure (HR =
1.04, 95% CI 1.00-1.07, p = 0.03). The HR for CBD increased
significantly with increasing cumulative exposure (HR = 1.04, 95% CI =
1.01-1.08, p = 0.02). The HR for CBD increased somewhat with increasing
LTW average exposure, but this increase was not significant at the 0.05
level (HR = 2.25, 95% CI = 0.94-5.35, p = 0.07).
None of the analyses Dr. Stone performed to check for
nonlinearities in exposure-response or the effects of smoking or age
substantially impacted the results of the analyses for beryllium
sensitization or CBD. The sensitivity analysis recommended by Crump and
Proctor, excluding workers hired prior to 1980 (see Document ID 1660,
p. 11), did not substantially impact the results
of the analyses for beryllium sensitization, but did affect the results
for CBD. The HR for CBD using cumulative exposure dropped to slightly
below 1 and was not statistically significant following exclusion of
workers hired before 1980 (HR 0.96, 95% CI 0.81-1.13, p = 0.6). OSHA
discusses this result further in the background document, concluding
that the reduced follow-up time for CBD in the subcohort hired in 1980
or later, in combination with genetic risk factors that may attenuate
both exposure-response and disease latency in some people, may explain
the lack of significant exposure-response observed in this sensitivity
analysis.
Because LTW average exposure was most strongly associated with
beryllium sensitization, OSHA used the final model for LTW average
exposure to estimate risk of sensitization at the preceding TWA PEL,
the final TWA PEL, and several alternate TWA PELs it considered.
Similarly, because cumulative exposure was most strongly associated
with CBD, OSHA used the final model for cumulative exposure to estimate
risk of CBD at the preceding, final, and alternate TWA PELs. In
calculating these risks, OSHA used a small, fixed estimate of
"baseline" risk (i.e., risk of sensitization or CBD among persons
with no known exposure to beryllium), as suggested by Crump and Proctor
(Document ID 1660) and NIOSH (Document ID 1725). Table VI-6 presents
the risk estimates for sensitization and the corresponding 95 percent
confidence intervals using two different fixed "background" rates of
sensitization, 1 percent and 0.5 percent. Table VI-7 presents the risk
estimates for sensitization and the corresponding 95 percent confidence
intervals using a fixed "background" rate of CBD of 0.5 percent. The
corresponding interval is based on the uncertainty in the exposure
coefficient (i.e., the predicted values based on the 95 percent
confidence limits for the exposure coefficient). Since the Cox
proportional hazards model does not estimate a baseline risk, this 95
percent interval fully represents statistical uncertainty in the risk
estimates.
Table VI-6--Predicted Cases of Sensitization per 1,000 Workers Exposed at the Preceding and Alternate PELs Based
on Cox Proportional Hazards Model, LTW Average Exposure Metric, With Corresponding Interval Based on the
Uncertainty in the Exposure Coefficient.
[1 Percent and 0.5 percent baselines]
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Exposure level (μg/m3\) cases/1000, 95% CI cases/1000, 95% CI
.5% baseline 1% baseline
----------------------------------------------------------------------------------------------------------------
2.0............................................. 42.75 11.4-160.34 85.49 22.79-320.69
1.0............................................. 14.62 7.55-28.31 29.24 15.10-56.63
0.5............................................. 8.55 6.14-11.90 17.10 12.29-23.80
0.2............................................. 6.20 5.43-7.07 12.39 10.86-14.15
0.1............................................. 5.57 5.21-5.95 11.13 10.42-11.89
----------------------------------------------------------------------------------------------------------------
Table VI-7--Predicted Cases of CBD per 1,000 Workers Exposed at the Preceding and Alternative PELs Based on Cox Proportional Hazards Model, Cumulative
Exposure Metric, with Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
[0.5 percent baseline]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure Duration
----------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
Exposure level (μg/m3\) ----------------------------------------------------------------------------------------------------------
Cumulative Estimated Estimated Estimated Estimated
(μg/m3\- cases/1000 μg/m3\- cases/1000 μg/m3\- cases/1000 μg/m3\- cases/1000
yrs) 95% CI yrs 95% CI yrs 95% CI yrs 95% CI
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0.......................................... 10.0 7.55 20.0 11.39 40.0 25.97 90.0 203.60
5.34-10.67 5.70-22.78 6.5-103.76 9.02-4595.6
7
1.0.......................................... 5.0 6.14 10.0 7.55 20.0 11.39 45.0 31.91
5.17-7.30 5.34-10.67 5.70-22.78 6.72-151.59
0.5.......................................... 2.5 5.54 5.0 6.14 10.0 7.55 22.5 12.63
5.08-6.04 5.17-7.30 5.34-10.67 5.79-27.53
0.2.......................................... 1.0 5.21 2.0 5.43 4.0 5.9 9.0 7.24
5.03-5.39 5.07-5.82 5.13-6.77 5.30-9.89
0.1.......................................... 0.5 5.1 1.0 5.21 2.0 5.43 4.5 6.02
5.02-5.19 5.03-5.39 5.07-5.82 5.15-7.03
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Cox proportional hazards model, used with the fixed
"baseline" rates of 0.5 percent and 1 percent, predicted risks of
sensitization totaling 43 and 86 cases per 1,000 workers, respectively,
or 4.3 and 8.6 percent, at the preceding PEL of 2 μg/m3\. The
predicted risk of CBD is 203 cases per 1,000 workers, or 20.3 percent,
at the preceding PEL of 2 μg/m3\, assuming 45 years of exposure
(cumulative exposure of 90 μg/m3\-yr).\20\ The predicted risks of
sensitization at the new PEL of 0.2 μg/m3\ are substantially lower,
at 6 and 12 cases per 1,000 for the baselines of 0.5% and 1.0%,
respectively. The predicted risk of CBD is also much lower at the new
TWA PEL of 0.2 μg/m3\ (9 μg/m3\-year), at 7 cases per 1,000
assuming 45 years of exposure.
---------------------------------------------------------------------------
\20\ The predictions for each model represent the estimated
probability of being sensitized or having CBD at one point in time,
rather than the cumulative risk over a lifetime of exposure, which
would be higher. Lifetime risks are presented in the FEA, Benefits
Analysis.
---------------------------------------------------------------------------
Due to limitations in the Cox analysis, including the small size of
the dataset, relatively limited exposure data from the plant's early
years, study size-related constraints on the statistical analysis of
the dataset, limited follow-
up time on many workers, and sensitivity of the results to the
"baseline" values assumed for sensitization and CBD, OSHA must
interpret the model-based risk estimates presented in Tables VI-6 and
VI-7 with caution. Uncertainties in these risk estimates are discussed
in the background document (Risk Analysis of the NJH Data Set from the
Beryllium Machining Facility in Cullman, Alabama--CBD and
Sensitization, OSHA, 2016). However, these uncertainties do not alter
OSHA's conclusions with regard to the significance of risk at the
preceding PEL and alternate PELs that OSHA considered, which are based
primarily on the Agency's review of the literature and the prevalence
analysis presented earlier in this section (also see Section VII,
Significance of Risk).
D. Lung Cancer
As discussed more fully in the Health Effects section of the
preamble, OSHA has determined beryllium to be a carcinogen based on an
extensive review of the scientific literature regarding beryllium and
cancer (see Section V.E). This review included an evaluation of the
human epidemiological, animal cancer, and mechanistic studies described
in the Health Effects section of this preamble. OSHA's conclusion is
supported by the findings of public health organizations such as the
International Agency for Research on Cancer (IARC), which has
determined beryllium and its compounds to be carcinogenic to humans
(Group 1 category) (IARC 2012, Document ID 0650); the National
Toxicology Program (NTP), which classifies beryllium and its compounds
as known carcinogens (NTP 2014, Document ID 0389); and the
Environmental Protection Agency (EPA), which considers beryllium to be
a probable human carcinogen (EPA 1998, Document ID 0661).
The Sanderson et al. study previously discussed in Health Effects
evaluated the association between beryllium exposure and lung cancer
mortality based on data from a beryllium processing plant in Reading,
PA (Sanderson et al., 2001, Document ID 1419). Specifically, this case-
control study evaluated lung cancer mortality in a cohort of 3,569 male
workers employed at the plant from 1940 to 1969 and followed through
1992. For each lung cancer victim, 5 age- and race-matched controls
were selected by incidence density sampling, for a total of 142
identified lung cancer cases and 710 controls.
A conditional logistic regression analysis showed an increased risk
of death from lung cancer in workers with higher exposures when dose
estimates were lagged by 10 and 20 years (Sanderson et al., 2001,
Document ID 1419). This lag was incorporated in order to account for
exposures that did not contribute to lung cancer because they occurred
after the induction of cancer. The authors noted that there was
considerable uncertainty in the estimation of exposure levels for the
1940s and 1950s and in the shape of the dose-response curve for lung
cancer. In a 2008 study, Schubauer-Berigan et al. reanalyzed the data,
adjusting for potential confounders of hire age and birth year
(Schubauer-Berigan et al., 2008, Document ID 1350). The study reported
a significant increasing trend (p < 0.05) in lung cancer mortality when
average (log transformed) exposure was lagged by 10 years. However, it
did not find a significant trend when cumulative (log transformed)
exposure was lagged by 0, 10, or 20 years (Schubauer-Berigan et al.,
2008, Table 3).
In formulating the final rule, OSHA was particularly interested in
lung cancer risk estimates from a 45-year (i.e., working lifetime)
exposure to beryllium levels between 0.1 μg/m3\ and 2 μg/m3\.
The majority of case and control workers in the Sanderson et al. (2001,
Document ID 1419) case-control analysis were first hired during the
1940s and 50s when exposures were extremely high (estimated daily
weighted averages (DWAs) >20 μg/m3\ for most jobs) in comparison to
the exposure range of interest to OSHA (Sanderson et al. 2001, Document
ID 1419, Table II). About two-thirds of cases and half of controls
worked at the plant for less than a year. Thus, a risk assessment based
on this exposure-response analysis would have needed to extrapolate
from very high to low exposures, based on a working population with
extremely short tenure. While OSHA risk assessments must often make
extrapolations to estimate risk within the range of exposures of
interest, the Agency acknowledges that these issues of short tenure and
high exposures would have created substantial uncertainty in a risk
assessment based on this particular study population.
In addition, the relatively high exposures of the least-exposed
workers in the study population might have created methodological
issues for the lung cancer case-control study design. Mortality risk is
expressed as an odds ratio that compares higher exposure quartiles to
the lowest quartile. It is preferable that excess risks attributable to
occupational beryllium be determined relative to an unexposed or
minimally exposed reference population. However, in this study
population, workers in the lowest quartile were exposed well above the
preceding OSHA TWA PEL (average exposure <11.2 μg/m3\) and may have
had a significant lung cancer risk. This issue would have introduced
further uncertainty into the lung cancer risks.
In 2011, Schubauer-Berigan et al. published a quantitative risk
assessment that addressed several of OSHA's concerns regarding the
Sanderson et al. analysis. This new risk assessment was based on an
update of the Reading cohort analyzed by Sanderson et al., as well as
workers from two smaller plants (Schubauer-Berigan et al. 2011,
Document ID 1265). This study population was exposed, on average, to
lower levels of beryllium and had fewer short-term workers than the
previous cohort analyzed by Sanderson et al. (2001, Document ID 1250)
and Schubauer-Berigan et al. (2008, Document ID 1350). Schubauer-
Berigan et al. (2011) followed the study population through 2005 where
possible, increasing the length of follow-up time overall by an
additional 17 years of observation compared to the previous analyses.
For these reasons, OSHA considered the Schubauer-Berigan (2011)
analysis more appropriate than Sanderson et al. (2001) and Schubauer-
Berigan (2008) for its risk assessment. OSHA therefore based its
preliminary QRA for lung cancer on the results from Schubauer-Berigan
et al. (2011).
OSHA received several comments about its choice of Schubauer-
Berigan et al. (2011) as the basis for its preliminary QRA for lung
cancer. NIOSH commented that OSHA's choice of Schubauer-Berigan et al.
for its preliminary analysis was appropriate because "[n]o other study
is available that presents quantitative dose-response information for
lung cancer, across a range of beryllium processing facilities"
(Document ID 1725, p. 7). In supporting OSHA's use of this study, NIOSH
emphasized in particular the study's inclusion of relatively low-
exposed workers from two facilities that began operations in the 1950s
(after employer awareness of acute beryllium disease (ABD) and CBD led
to efforts to minimize worker exposures to beryllium), as well as the
presence of both soluble and poorly soluble forms of beryllium in the
facilities studied (Document ID 1725, p. 7).
According to Dr. Paolo Boffetta, who submitted comments on this
study,
Schubauer-Berigan et al. (2011) is not the most relevant study
available to OSHA for its lung cancer risk analysis. Dr. Boffetta
argued that the most informative study of lung cancer risk in the
beryllium industry after 1965 is one that he developed in 2015
(Boffetta et al., 2015), which he described as a pooled analysis of 11
plants and 4 distribution centers (Document ID 1659, p. 1). However,
Dr. Boffetta did not provide OSHA with the manuscript of his study,
which he stated was under review for publication. Instead, he reported
some results of the study and directed OSHA to an abstract of the study
in the 2015 Annual Conference of the Society for Epidemiologic Research
(Document ID 1659; Document ID 1661, Attachment 1).
Because only an abstract of Boffetta et al.'s 2015 study was
available to OSHA (see Document ID 1661, Attachment 1), OSHA could not
properly evaluate it or use it as the basis of a quantitative risk
assessment for lung cancer. Nevertheless, OSHA has addressed comments
Dr. Boffetta submitted based on his analyses in the relevant sections
of the final QRA for lung cancer below. Because it was not possible to
use this study for its lung cancer QRA and OSHA is not aware of other
studies appropriate for use in its lung cancer QRA (nor did commenters
besides Dr. Boffetta suggest that OSHA use any additional studies for
this purpose), OSHA finds that the body of available evidence has not
changed since the Agency conducted its preliminary QRA based on
Schubauer-Berigan et al. (2011, Document ID 1265). Therefore, OSHA
concludes that Schubauer-Berigan et al. (2011) is the most appropriate
study for its final lung cancer QRA, presented below.
1. QRA for Lung Cancer Based on Schubauer-Berigan et al. (2011)
The cohort studied by Schubauer-Berigan et al. (2011, Document ID
1265) included 5,436 male workers who had worked for at least 2 days at
the Reading facility or at the beryllium processing plants in Hazleton,
PA and Elmore, OH prior to 1970. The authors developed job-exposure
matrices (JEMs) for the three plants based on extensive historical
exposure data, primarily short-term general area and personal breathing
zone samples, collected on a quarterly basis from a wide variety of
operations. These samples were used to create DWA estimates of workers'
full-shift exposures, using records of the nature and duration of tasks
performed by workers during a shift. Details on the JEM and DWA
construction can be found in Sanderson et al. (2001, Document ID 1250),
Chen et al. (2001, Document ID 1593), and Couch et al. (2010, Document
ID 0880).
Workers' cumulative exposures (μg/m3\-days) were estimated by
summing daily average exposures (assuming five workdays per week)
(Schubauer-Berigan et al., 2011). To estimate mean exposure (μg/
m3\), cumulative exposure was divided by exposure time (in days),
accounting where appropriate for lag time. Maximum exposure (μg/
m3\) was calculated as the highest annual DWA on record for a worker
from the first exposure until the study cutoff date of December 31,
2005, again accounting where appropriate for lag time. Exposure
estimates were lagged by 5, 10, 15, and 20 years in order to account
for exposures that may not have contributed to lung cancer because of
the long latency required for manifestation of the disease. The authors
also fit models with no lag time.
As shown in Table VI-8 below, estimated exposure levels for workers
from the Hazleton and Elmore plants were on average far lower than
those for workers from the Reading plant (Schubauer-Berigan et al.,
2011). Whereas the median worker from Hazleton had a mean exposure
across his tenure of less than 1.5 μg/m3\ and the median worker
from Elmore had a mean exposure of less than 1 μg/m3\, the median
worker from Reading had a mean exposure of 25 μg/m3\. The Elmore
and Hazleton worker populations also had fewer short-term workers than
the Reading population. This was particularly evident at Hazleton,
where the median value for cumulative exposure among cases was higher
than at Reading despite the much lower mean and maximum exposure
levels.
Table VI-8--Cohort Description and Distribution of Cases by Exposure Level
--------------------------------------------------------------------------------------------------------------------------------------------------------
All plants Reading plant Hazleton plant Elmore plant
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of cases................................ ....................................... 293 218 30 45
Number of non-cases............................ ....................................... 5143 3337 583 1223
Median value for mean exposure................. No lag................................. 15.42 25 1.443 0.885
(μg/m3\) among cases....................... 10-year lag............................ 15.15 25 1.443 0.972
Median value for cumulative exposure........... No lag................................. 2843 2895 3968 1654
(μg/m3\-days) among cases.................. 10-year lag............................ 2583 2832 3648 1449
Median value for maximum exposure.............. No lag................................. 25 25.1 3.15 2.17
(μg/m3\) among cases....................... 10-year lag............................ 25 25 3.15 2.17
Number of cases with potential asbestos ....................................... 100 (34%) 68 (31%) 16 (53%) 16 (36%)
exposure.
Number of cases who were professional workers.. ....................................... 26 (9%) 21 (10%) 3 (10%) 2 (4%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table adapted from Schubauer-Berigan et al., 2011, Document ID 1265, Table 1.
Schubauer-Berigan et al. analyzed the data set using a variety of
exposure-response modeling approaches, including categorical analyses,
continuous-variable piecewise log-linear models, and power models
(2011, Document ID 1265). All models adjusted for birth cohort and
plant. Because exposure values were log-transformed for the power model
analyses, the authors added small values to exposures of 0 in lagged
analyses (0.05 μg/m3\ for mean and maximum exposure, 0.05 μg/
m3\-days for cumulative exposure). The authors used restricted cubic
spline models to assess the shape of the exposure-response curves and
suggest appropriate parametric model forms. The Akaike Information
Criterion (AIC) value was used to evaluate the fit of different model
forms and lag times.
Because smoking information was available for only about 25 percent
of the cohort (those employed in 1968), smoking could not be controlled
for directly in the models. Schubauer-Berigan et al. reported that
within the subset with smoking information, there was little difference
in smoking by cumulative or maximum exposure category, suggesting that
smoking was unlikely to act as a confounder in the cohort. In addition
to models based on the full cohort, Schubauer-Berigan et al. also
prepared risk estimates based on models excluding professional workers
(ten percent of cases) and workers believed to have asbestos exposure
(one-third of cases). These models were
intended to mitigate the potential impact of smoking and asbestos as
confounders.\21\
---------------------------------------------------------------------------
\21\ The authors appeared to reason that if professional workers
had both lower beryllium exposures and lower smoking rates than
production workers, smoking could be a confounder in the cohort
comprising both production and professional workers. However,
smoking was unlikely to be correlated with beryllium exposure among
production workers, and would therefore probably not act as a
confounder in a cohort excluding professional workers.
---------------------------------------------------------------------------
The authors found that lung cancer risk was strongly and
significantly related to mean, cumulative, and maximum measures of
workers' exposure (all models reported in Schubauer-Berigan et al.,
2011, Document ID 1265). They selected the best-fitting categorical,
power, and monotonic piecewise log-linear (PWL) models with a 10-year
lag to generate HRs for male workers with a mean exposure of 0.5 μg/
m3\ (the current NIOSH Recommended Exposure Limit for beryllium).\22\
In addition, they estimated the daily weighted average exposure that
would be associated with an excess lung cancer mortality risk of one in
one thousand (.005 μg/m3\ to .07 μg/m3\ depending on model
choice). To estimate excess risk of cancer, they multiplied these
hazard ratios by the 2004 to 2006 background lifetime lung cancer rate
among U.S. males who had survived, cancer-free, to age 30. At OSHA's
request, Dr. Schubauer-Berigan also estimated excess lung cancer risks
for workers with mean exposures at the preceding PEL of 2 μg/m3\
and at each of the other alternate PELs that were under consideration:
1 μg/m3\, 0.2 μg/m3\, and 0.1 μg/m3\ (Document ID 0521).
The resulting risk estimates are presented in Table VI-9 below.
---------------------------------------------------------------------------
\22\ Here, "monotonic PWL model" means a model producing a
monotonic exposure-response curve in the 0 to 2 μg/m3\ range.
Table VI-9--Excess Lung Cancer Risk per 1,000 [95% Confidence Interval] For Male Workers at Alternate PELs
[Based on Schubauer-Berigan et al., 2011]
----------------------------------------------------------------------------------------------------------------
Mean exposure
Exposure-response model -------------------------------------------------------------------------------
0.1 μg/m3\ 0.2 μg/m3\ 0.5 μg/m3\ 1 μg/m3\ 2 μg/m3\
----------------------------------------------------------------------------------------------------------------
Best monotonic PWL--all workers. 7.3 [2.0-13] 15 [3.3-29] 45 [9-98] 120 [20-340] 140 [29-370]
Best monotonic PWL--excluding 3.1 [<0-11] 6.4 [<0-23] 17 [<0-74] 39 [39-230] 61 [<0-280]
professional and asbestos
workers........................
Best categorical--all workers... 4.4 [1.3-8] 9 [2.7-17] 25 [6-48] 59 [13-130] 170 [29-530]
Best categorical--excluding 1.4 [<0-6.0] 2.7 [<0-12] 7.1 [<0-35] 15 [<0-87] 33 [<0-290]
professional and asbestos
workers........................
Power model--all workers........ 12 [6-19] 19 [9.3-29] 30 [15-48] 40 [19-66] 52 [23-88]
Power model--excluding 19 [8.6-31] 30 [13-50] 49 [21-87] 68 [27-130] 90 [34-180]
professional and asbestos
workers........................
----------------------------------------------------------------------------------------------------------------
Source: Schubauer-Berigan, Document ID 0521, pp. 6-10.
Schubauer-Berigan et al. (2011, Document ID 1265) discuss several
strengths, weaknesses, and uncertainties of their analysis. Strengths
include a long (>30 years) follow-up time and the extensive exposure
and work history data available for the development of exposure
estimates for workers in the cohort. Weaknesses and uncertainties of
the study include the limited information available on workers' smoking
habits: As mentioned above, smoking information was available only for
workers employed in 1968, about 25 percent of the cohort. Another
potential weakness was that the JEMs used did not account for possible
respirator use among workers in the cohort. The authors note that
workers' exposures may therefore have been overestimated, and that
overestimation may have been especially severe for workers with high
estimated exposures. They suggest that overestimation of exposures for
workers in highly exposed positions may have caused attenuation of the
exposure-response curve in some models at higher exposures. This could
cause the relationship between exposure level and lung cancer risk to
appear weaker than it would in the absence of this source of error in
the estimation of workers' beryllium exposures.
Schubauer-Berigan et al. (2011) did not discuss the reasons for
basing risk estimates on mean exposure rather than cumulative exposure,
which is more commonly used for lung cancer risk analysis. OSHA
believes the decision may involve the non-monotonic relationship the
authors observed between cancer risk and cumulative exposure level. As
discussed previously, workers from the Reading plant frequently had
very short tenures and high exposures, yielding lower cumulative
exposures compared to cohort workers from other plants with longer
employment. Despite the low estimated cumulative exposures among the
short-term Reading workers, they may have been at high risk of lung
cancer due to the tendency of beryllium to persist in the lung for long
periods. This could lead to the appearance of a non-monotonic
relationship between cumulative exposure and lung cancer risk. It is
possible that a dose-rate effect may exist for beryllium, such that the
risk from a cumulative exposure gained by long-term, low-level exposure
is not equivalent to the risk from a cumulative exposure gained by very
short-term, high-level exposure. In this case, mean exposure level may
better correlate with the risk of lung cancer than cumulative exposure
level. For these reasons, OSHA considers the authors' use of the mean
exposure metric to be appropriate and scientifically defensible for
this particular dataset.
Dr. Boffetta's comment, mentioned above, addressed the relevance of
the Schubauer-Berigan et al. (2011) cohort to determining whether
workers currently employed in the beryllium industry experience an
increased lung cancer hazard (Document ID 1659, pp. 1-2). His comment
also analyzed the methods and findings in Schubauer-Berigan et al.
(2011) (Document ID 1659, pp. 2-3). Notably, he stated that his own
study, Boffetta et al. (2015) provides better information for risk
assessment than does Schubauer-Berigan et al. (2011) (Document ID 1659,
pp. 1-2). As discussed above, OSHA cannot rely on a study for its QRA
(Boffetta et al., 2015) that has not been submitted to the record and
is not otherwise available to OSHA. However, in the discussion below,
OSHA addresses Dr. Boffetta's study to the extent it can given the
limited information available to the Agency. OSHA also responds to Dr.
Boffetta's comments on Schubauer-Berigan et al. (2011, Document ID
1265) and Boffetta et al. (2014, Document ID 0403), which Dr. Boffetta
asserts provides evidence that poorly soluble beryllium compounds are
not associated with lung cancer (Document ID 1659, p. 1).
Boffetta argued that the most informative study in the modern
(post-1965) beryllium industry is Boffetta et al. (2015, Document ID
1661, Attachment 1). According to Boffetta's comment, the study found
an SMR of 1.02 (95% CI 0.94-1.10, based on 672 deaths) for the overall
cohort and an SMR for lung cancer among workers exposed only to
insoluble beryllium of 0.93 (95% CI 0.79-1.08, based on 157 deaths).
Boffetta noted that his study was based on 23 percent more overall
deaths than the Schubauer-Berigan et al. cohort (Document ID 1659, pp.
1-2). As stated earlier, this study is unpublished and was not provided
to OSHA. The abstract provided by Materion (Document ID 1661,
Attachment 1) included very little information beyond the SMRs
reported; for example, it provided no information about the
manufacturing plants and distribution centers included, workers'
beryllium exposure levels, how the cohorts were defined, or how the
authors determined the solubility of the beryllium to which workers
were exposed. OSHA is therefore unable to evaluate the quality or
conclusions of this study.
Dr. Boffetta also commented that there is a lack of evidence of
increased lung cancer risk among workers exposed only to poorly soluble
beryllium compounds (Document ID 1659, p. 1). To support this
statement, he cited a study he published in 2014 of workers at four
"insoluble facilities" (Boffetta et al., 2014) and Schubauer-Berigan
et al.'s 2011 study, arguing that increased cancer risk in beryllium-
exposed workers in those two studies was only observed in workers
employed in Reading and Lorain prior to 1955. Workers employed at the
other plants and workers who were first employed in Reading and Lorain
after 1955, according to Dr. Boffetta, were exposed primarily to poorly
soluble forms of beryllium and did not experience an increased risk of
lung cancer. Dr. Boffetta further stated that his unpublished paper
(Boffetta et al., 2015) shows a similar result (Document ID 1659, p.
1).
OSHA carefully considered Dr. Boffetta's argument regarding the
status of poorly soluble beryllium compounds, and did not find
persuasive evidence showing that the solubility of the beryllium to
which the workers in the studies he cited were exposed accounts for the
lack of statistically significantly elevated risk in the Boffetta et
al. (2014) cohort or the Schubauer-Berigan et al. (2011) subcohort.
While it is true that the SMR for lung cancer was not statistically
significantly elevated in the Schubauer-Berigan et al. (2011) study
when workers hired before 1955 in the Reading and Lorain plants were
excluded from the study population, or in the study of four facilities
published by Boffetta et al. in 2014, there are various possible
reasons for these results that Dr. Boffetta did not consider in his
comment. As discussed below, OSHA finds that the type of beryllium
compounds to which these workers were exposed is not likely to explain
Dr. Boffetta's observations.
As discussed in Section V, Health Effects and in comments submitted
by NIOSH, animal toxicology evidence shows that poorly soluble
beryllium compounds can cause cancer. IARC determined that poorly
soluble forms of beryllium are carcinogenic to humans in its 2012
review of Group I carcinogens (see section V.E.5 of this preamble;
Document ID 1725, p. 9; IARC, 2012, Document ID 0650). NIOSH noted that
poorly soluble forms of beryllium remain in the lung for longer time
periods than soluble forms, and can therefore create prolonged exposure
of lung tissue to beryllium (Document ID 1725, p. 9). This prolonged
exposure may lead to the sustained tissue inflammation that causes many
forms of cancer and is believed to be one pathway for carcinogenesis
due to beryllium exposure (see Section V, Health Effects).
The comments from NIOSH also demonstrate that the available
information cannot distinguish between the effects of soluble and
poorly soluble beryllium. NIOSH submitted information on the solubility
of beryllium in the Schubauer-Berigan et al. (2011) cohort, stating
that operations typically involving both soluble and poorly soluble
beryllium were performed at all three of the beryllium plants included
in the study (Document ID 1725, p. 9; Ward et al., 1992, Document ID
1378). Based on evaluations of the JEMs and work histories of employees
in the cohort (which were not published in the 2011 Schubauer-Berigan
et al. paper), NIOSH stated that "the vast majority of beryllium work-
time at all three of these facilities was due to either insoluble or
mixed chemical forms. In fact, insoluble beryllium was the largest
single contributor to work-time (for beryllium exposure of known
solubility class) at the three facilities across most time periods"
(Document ID 1725, p. 9). NIOSH also provided figures showing the
contribution of insoluble beryllium to exposure over time in the
Schubauer-Berigan et al. (2011) study, as well as the relatively small
proportion of work years during which workers in the study were exposed
exclusively to either soluble or poorly soluble forms (Document ID
1725, pp. 10-11).
Boffetta et al. (2014, Document ID 0403) examined a population of
workers allegedly exposed exclusively to poorly soluble beryllium
compounds, in which overall SMR for lung cancer was not statistically
significantly elevated (SMR 96.0, 95% CI 80.0-114.3). Boffetta et al.
concluded, "[a]lthough a small risk for lung cancer is compatible with
our results, we can confidently exclude an excess greater than 20%" in
the study population (Boffetta et al., 2014, p. 592). Limitations of
the study include a lack of information on many workers' job titles, a
lack of any beryllium exposure measurements, and the very short-term
employment of most cohort members at the study facilities (less than 5
years for 72 percent of the workers) (Boffetta et al., 2014).
OSHA reviewed this study, and finds that it does not contradict the
findings of the Schubauer-Berigan et al. (2011) lung cancer risk
analysis for several reasons. First, as shown in Table VI-9 above, none
of the predictions of excess risk in the risk analysis exceed 20
percent (200 per 1,000 workers); most are well below this level, and
thus are well within the range that Boffetta et al. (2014) state they
cannot confidently exclude. Thus, the statement by Boffetta et al. that
the risk of excess lung cancer is no higher than 20 percent is actually
consistent with the risk findings from Schubauer-Berigan et al. (2011)
presented above. Second, the fact that most workers in the cohort were
employed for less than five years suggests that most workers'
cumulative exposures to beryllium were likely to be quite low, which
would explain the non-elevated SMR for lung cancer in the study
population regardless of the type of beryllium to which workers were
exposed. The SMR for workers employed in the study facilities for at
least 20 years was elevated (112.7, CI 66.8-178.1) (Boffetta et al.,
2014, Document ID 0403, Table 3),\23\ supporting OSHA's observation
that the lack of elevated SMR in the cohort overall may be due to
short-term
employment and low cumulative exposures.
---------------------------------------------------------------------------
\23\ This SMR was not statistically significantly elevated,
probably due to the small size of this subcohort (153 total deaths,
18 lung cancer deaths).
---------------------------------------------------------------------------
Finally, the approach of Boffetta et al. (2014), which relies on
SMR analyses, does not account for the healthy worker effect. SMRs are
calculated by comparing disease levels in the study population to
disease levels in the general population, using regional or national
reported disease rates. However, because working populations tend to
have lower disease rates than the overall population, SMRs can
underestimate excess risk of disease in those populations. The SMR in
Boffetta et al. (2014) for overall mortality in the study population
was statistically significantly reduced (94.7, 95 percent CI 89.9-
99.7), suggesting a possible healthy worker effect. The SMR for overall
mortality was even further reduced in the category of workers with at
least 20 years of employment (87.7, 95 percent CI 74.3-102.7), in which
an elevated SMR for lung cancer was observed. NIOSH commented that
"[i]n a modern industrial population, the expected SMR for lung cancer
would be approximately 0.93 [Park et al. (1991)]" (Document ID 1725,
p. 8). This is lower than the SMR for lung cancer (96) observed in
Boffetta et al. (2014) and much lower than the SMR for lung cancer in
the category of workers employed for at least 20 years (112.7), which
is the group most likely to have had sufficient exposure and latency to
show excess lung cancer (Boffetta et al., 2014, Document ID 0403,
Tables 2 and 3). Thus, it appears that the healthy worker effect is
another factor (in addition to low cumulative exposures) that may
account for the findings of Boffetta et al.'s 2014 study.
Taken together, OSHA finds that the animal toxicology evidence on
the carcinogenicity of poorly soluble beryllium forms, the long
residence of poorly soluble beryllium in the lung, the likelihood that
most workers in Schubauer-Berigan et al. (2011) were exposed to a
mixture of soluble and poorly soluble beryllium forms, and the points
raised above regarding Boffetta et al. (2014) rebut Boffetta's claim
that low solubility of beryllium compounds is the most likely
explanation for the lack of statistically significantly elevated SMR
results.
Dr. Boffetta's comment also raised technical questions regarding
the Schubauer-Berigan et al. (2011, Document ID 1265) risk analysis. He
noted that risk estimates at low exposures are dependent on choice of
model in their analysis; the authors' choice of a single "best" model
was based on purely statistical criteria, and the results of the
statistics used (AIC) were similar between the models" (Document ID
1659, p. 2). Therefore, according to Dr. Boffetta, "there is ample
uncertainty about the shape of the dose-response function in the low-
dose range" (Document ID 1659, p. 3).
OSHA agrees that it is difficult to distinguish a single "best"
model from the set of models presented by Schubauer-Berigan et al.
(2011), and that risk estimates at low exposure levels vary depending
on choice of model. That is one reason OSHA presented results from all
of the models (see Table VI-9). OSHA further agrees that there is
uncertainty in the lung cancer risk estimates, the estimation of which
(unlike for CBD) required extrapolation below beryllium exposure levels
experienced by workers in the Schubauer-Berigan et al. (2011) study.
However, the Schubauer-Berigan risk assessment's six best-fitting
models all support OSHA's significant risk determination, as they all
predict a significant risk of lung cancer at the preceding TWA PEL of 2
μg/m3\ (estimates ranging from 33 to 170 excess lung cancers per
1,000 workers) and a substantially reduced, though still significant,
risk of lung cancer at the new TWA PEL of 0.2 μg/m3\ (estimates
ranging from 3 to 30 excess lung cancers per 1,000 workers) (see Table
VI-9).
Dr. Boffetta also noted that the risk estimates provided by
Schubauer-Berigan et al. (2011, Document ID 1265) for OSHA's lung
cancer risk assessment depend on the background lung cancer rate used
in excess risk calculations, and that industrial workers may have a
different background lung cancer risk than the U.S. population as a
whole (Document ID 1659, p. 2). OSHA agrees that choice of background
risk could influence the number of excess lung cancers predicted by the
models the Agency relied on for its lung cancer risk estimates.
However, choice of background risk did not influence OSHA's finding
that excess lung cancer risks would be substantially reduced by a
decrease in exposure from the preceding TWA PEL to the final TWA PEL,
because the same background risk was factored into estimates of risk at
both levels. Furthermore, the Schubauer-Berigan et al. (2011) estimates
of excess lung cancer from exposure at the preceding PEL of 2 μg/
m3\ (ranging from 33 to 170 excess lung cancers per 1,000 workers,
depending on the model) are much higher than the level of 1 per 1,000
that OSHA finds to be clearly significant. Even at the final TWA PEL of
0.2 μg/m3\, the models demonstrate a range of risks of excess lung
cancers of 3 to 30 per 1,000 workers, estimates well above the
threshold for significant risk (see Section II, Pertinent Legal
Authority). Small variations in background risk across different
populations are highly unlikely to influence excess lung cancer risk
estimates sufficiently to influence OSHA's finding of significant risk
at the preceding TWA PEL, which is the finding OSHA relies on to
support the need for a new standard.
Finally, Dr. Boffetta noted that the models that exclude
professional and asbestos workers (the groups that Schubauer-Berigan et
al. believed could be affected by confounding from tobacco and asbestos
exposure) showed non-significant increases in lung cancer with
increasing beryllium exposure. According to Dr. Boffetta, this suggests
that confounding may contribute to the results of the models based on
the full population. He speculates that if more precise information on
confounding exposures were available, excess risk estimates might be
further reduced (Document ID 1659, p. 2).
OSHA agrees with Dr. Boffetta that there is uncertainty in the
Schubauer-Berigan et al. (2011) lung cancer risk estimates, including
uncertainty due to limited information on possible confounding from
associations between beryllium exposure level and workers' smoking
habits or occupational co-exposures. However, in the absence of
detailed smoking and co-exposure information, the models excluding
professional and asbestos workers are a reasonable approach to
addressing the possible effects of unmeasured confounding. OSHA's
decision to include these models in its preliminary and final QRAs
therefore represents the Agency's best available means of dealing with
this uncertainty.
E. Risk Assessment Conclusions
As described above, OSHA's risk assessment for beryllium
sensitization and CBD relied on two approaches: (1) Review of the
literature, and (2) analysis of a data set provided by NJH. OSHA has a
high level of confidence in its finding that the risks of sensitization
and CBD are above the benchmark of 1 in 1,000 at the preceding PEL, and
the Agency believes that a comprehensive standard requiring a
combination of more stringent controls on beryllium exposure will
reduce workers' risk of both sensitization and CBD. Programs that have
reduced median levels to below 0.1 μg/m3\ and tightly controlled
both respiratory exposure and dermal contact have substantially reduced
risk of sensitization within the first years of exposure. These
conclusions are supported by the results of several studies conducted
in facilities dealing
with a variety of production activities and physical forms of beryllium
that have reduced workers' exposures substantially by implementing
stringent exposure controls and PPE requirements since approximately
2000. In addition, these conclusions are supported by OSHA's analyses
of the NJH data set, which contains highly-detailed exposure and work
history information on several hundred beryllium workers.
Furthermore, OSHA believes that more stringent control of airborne
beryllium exposures will reduce beryllium-exposed workers' significant
risk of lung cancer. The risk estimates from the lung cancer study by
Schubauer-Berigan et al. (2011, Document ID 1265; 0521), described
above, range from 33 to 170 excess lung cancers per 1,000 workers
exposed at the preceding PEL of 2 μg/m3\, based on the study's six
best-fitting models. These models each predict substantial reductions
in risk with reduced exposure, ranging from 3 to 30 excess lung cancers
per 1,000 workers exposed at the final PEL of 0.2 μg/m3\. The
evidence of lung cancer risk from the Schubauer-Berigan et al. (2011)
risk assessment provides additional support for OSHA's conclusions
regarding the significance of risk of adverse health effects for
workers exposed to beryllium levels at and below the preceding PEL.
However, the lung cancer risks required a sizable low dose
extrapolation below beryllium exposure levels experienced by workers in
the Schubauer-Berigan et al. (2011) study. As a result, there is
greater uncertainty regarding the lung cancer risk estimates than there
is for the risk estimates for beryllium sensitization and CBD. The
conclusions with regard to significance of risk are presented and
further discussed in section VII of the preamble.
VII. Significance of Risk
In this section, OSHA discusses its findings that workers exposed
to beryllium at and below the preceding TWA PEL face a significant risk
of material impairment of health or functional capacity within the
meaning of the OSH Act, and that the new standards will substantially
reduce this risk. To make the significance of risk determination for a
new final or proposed standard, OSHA uses the best available scientific
evidence to identify material health impairments associated with
potentially hazardous occupational exposures and to evaluate exposed
workers' risk of these impairments assuming exposure over a working
lifetime. As discussed in section II, Pertinent Legal Authority, courts
have stated that OSHA should consider all forms and degrees of material
impairment--not just death or serious physical harm. To evaluate the
significance of the health risks that result from exposure to hazardous
chemical agents, OSHA relies on epidemiological, toxicological, and
experimental evidence. The Agency uses both qualitative and
quantitative methods to characterize the risk of disease resulting from
workers' exposure to a given hazard over a working lifetime (generally
45 years) at levels of exposure reflecting compliance with the
preceding standard and compliance with the new standards (see Section
II, Pertinent Legal Authority). When determining whether a significant
risk exists OSHA considers whether there is a risk of at least one-in-
a-thousand of developing a material health impairment from a working
lifetime of exposure. The Supreme Court has found that OSHA is not
required to support its finding of significant risk with scientific
certainty, but may instead rely on a body of reputable scientific
thought and may make conservative assumptions (i.e., err on the side of
protecting the worker) in its interpretation of the evidence (Section
II, Pertinent Legal Authority).
OSHA's findings in this section follow in part from the conclusions
of the preceding sections V, Health Effects, and VI, Risk Assessment.
In this preamble at section V, Health Effects, OSHA reviewed the
scientific evidence linking occupational beryllium exposure to a
variety of adverse health effects and determined that beryllium
exposure causes sensitization, CBD, and lung cancer, and is associated
with various other adverse health effects (see section V.D, V.E, and
V.F). In this preamble at section VI, Risk Assessment, OSHA found that
the available epidemiological data are sufficient to evaluate risk for
beryllium sensitization, CBD, and lung cancer among beryllium-exposed
workers. OSHA evaluated the risk of sensitization, CBD, and lung cancer
from levels of airborne beryllium exposure that were allowed under the
previous standard, as well as the expected impact of the new standards
on risk of these conditions. In this section of the preamble, OSHA
explains its determination that the risk of material impairments of
health, particularly CBD and lung cancer, from occupational exposures
allowable under the preceding TWA PEL of 2 μg/m3\ is significant,
and is substantially reduced but still significant at the new TWA PEL
of 0.2 μg/m3\. Furthermore, evidence reviewed in section VI, Risk
Assessment, shows that significant risk of CBD and lung cancer could
remain in workplaces with exposures as low as the new action level of
0.1 μg/m3\. OSHA also explains here that the new standards will
reduce the occurrence of sensitization.
In the NPRM, OSHA preliminarily determined that both CBD and lung
cancer are material impairments of health. OSHA also preliminarily
determined that a working lifetime (45 years) of exposure to airborne
beryllium at the preceding time-weighted average permissible exposure
limit (TWA PEL) of 2 μg/m3\ would pose a significant risk of both
CBD and lung cancer, and that this risk is substantially reduced but
still significant at the new TWA PEL of 0.2 μg/m3\. OSHA did not
make a preliminary determination as to whether beryllium sensitization
is a material impairment of health because, as the Agency explained in
the NPRM, it was not necessary to make such a determination. The
Agency's preliminary findings on CBD and lung cancer were sufficient to
support the promulgation of new beryllium standards.
Upon consideration of the entire rulemaking record, including the
comments and information submitted to the record in response to the
preliminary Health Effects, Risk Assessment, and Significance of Risk
analyses (NPRM Sections V, VI, and VIII), OSHA reaffirms its
preliminary findings that long-term exposure at the preceding TWA PEL
of 2 μg/m3\ poses a significant risk of material impairment of
workers' health, and that adoption of the new TWA PEL of 0.2 μg/m3\
and other provisions of the final standards will substantially reduce
this risk.
Material Impairment of Health
As discussed in Section V, Health Effects, CBD is a respiratory
disease caused by exposure to beryllium. CBD develops when the body's
immune system reacts to the presence of beryllium in the lung, causing
a progression of pathological changes including chronic inflammation
and tissue scarring. CBD can also impair other organs such as the
liver, skin, spleen, and kidneys and cause adverse health effects such
as granulomas of the skin and lymph nodes and cor pulmonale (i.e.,
enlargement of the heart) (Conradi et al., 1971 (Document ID 1319);
ACCP, 1965 (1286); Kriebel et al., 1988a (1292) and b (1473)).
In early, asymptomatic stages of CBD, small granulomatous lesions
and mild inflammation occur in the lungs. Over time, the granulomas can
spread and lead to lung fibrosis (scarring) and
moderate to severe loss of pulmonary function, with symptoms including
a persistent dry cough and shortness of breath (Saber and Dweik, 2000,
Document ID 1421). Fatigue, night sweats, chest and joint pain,
clubbing of fingers (due to impaired oxygen exchange), loss of
appetite, and unexplained weight loss may occur as the disease
progresses (Conradi et al., 1971, Document ID 1319; ACCP, 1965 (1286);
Kriebel et al., 1988 (1292); Kriebel et al., 1988 (1473)).
Dr. Lee Newman, speaking at the public hearing on behalf of the
American College of Occupational and Environmental Medicine (ACOEM),
testified on his experiences treating patients with CBD: "as a
physician who has spent most of my [practicing] career seeing patients
with exposure to beryllium, with beryllium sensitization, and with
chronic beryllium disease including those who have gone on to require
treatment and to die prematurely of this disease . . . [I've seen]
hundreds and hundreds, probably over a thousand individuals during my
career who have suffered from this condition" (Document ID 1756, Tr.
79). Dr. Newman further testified about his 30 years of experience
treating CBD in patients at various stages of the disease:
. . . some of them will go from being sensitized to developing
subclinical disease, meaning that they have no symptoms. As I
mentioned earlier, most of those will, if we actually do the tests
of their lung function and their oxygen levels in their blood, those
people are already demonstrating physiologic abnormality. They
already have disease affecting their health. They go on to develop
symptomatic disease and progress to the point where they require
treatment. And sometimes to the extent of even requiring a [lung]
transplant (Document ID 1756, Tr. 131).
Dr. Newman described one example of a patient who developed CBD
from his occupational beryllium exposure and "who went on to die
prematurely with a great deal of suffering along the way due to the
condition chronic beryllium disease" (Document ID 1756, Tr. 80).
During her testimony at the public hearing, Dr. Lisa Maier of
National Jewish Health (NJH) provided an example from her experience
with treating CBD patients. "This gentleman started to have a cough, a
dry cough in 2011 . . . His symptoms progressed and he developed
shortness of breath, wheezing, chills, night sweats, and fatigue. These
were so severe that he was eventually hospitalized" (Document ID 1756,
Tr. 105). Dr. Maier noted that this patient had no beryllium exposure
prior to 2006, and that his CBD had developed from beryllium exposure
in his job melting an aluminum alloy in a foundry casting airplane
parts (Document ID 1756, Tr. 105-106). She described how her patient
could no longer work because of his condition. "He requires oxygen and
systemic therapy . . . despite aggressive treatment [his] test findings
continue to demonstrate worsening of his disease and increased needs
for oxygen and medications as well as severe side effects from
medications. This patient may well need a lung transplant if this
disease continues to progress . . . " (Document ID 1756, Tr. 106-107).
The likelihood, speed, and severity of individuals' transition from
asymptomatic to symptomatic CBD is understood to vary widely, with some
individuals responding differently to exposure cessation and treatment
than others (Sood, 2009, Document ID 0456; Mroz et al., 2009 (1443)).
In the public hearing, Dr. Newman testified that the great majority of
individuals with very early stage CBD in a cross-sectional study he
published (Pappas and Newman, 1993) had physiologic impairment. Thus,
even before x-rays or CAT scans found evidence of CBD, the lung
functions of those individuals were abnormal (Document ID 1756, Tr.
112). Materion commented that the best available evidence on the
transition from asymptomatic to more severe CBD is a recent
longitudinal study by Mroz et al. (2009, Document ID 1443), which found
that 19.3 percent of individuals with CBD developed clinical
abnormalities requiring oral immunosuppressive therapy (Document ID
1661, pp. 5-6). The authors' overall conclusions in that study include
a finding that adverse physiological changes among initially
asymptomatic CBD patients progress over time, requiring many
individuals to be treated with corticosteroids, and that the patients'
levels of beryllium exposure may affect progression (Mroz et al.,
2009). Dr. Maier, a co-author of the study, testified that studies
"indicate that higher levels of exposure not only are risk factors for
[developing CBD in general] but also for more severe [CBD] (Document ID
1756, Tr. 111).\24\
---------------------------------------------------------------------------
\24\ The study by Mroz et al. (2009, Document ID 1443) included
all individuals who were clinically evaluated at NJH between 1982
and 2002 and were found to have CBD on baseline clinical evaluation.
All cohort members were identified by abnormal BeLPTs before
identification of symptoms, physiologic abnormalities, or
radiographic changes. All members were offered evaluation for
clinical abnormalities every 2 years through 2002, including
pulmonary function testing, exercise testing, chest radiograph with
International Labor Organization (ILO) B-reading, fiberoptic
bronchoscopy with bronchoalveolar lavage (BAL), and transbronchial
lung biopsies. Of 171 CBD cases, 33 (19.3%) developed clinical
abnormalities requiring oral immunosuppressive therapy, at an
average of 1.4 years after the initial diagnosis of CBD. To examine
the effect of beryllium exposure level on the progression of CBD,
Mroz et al. compared clinical manifestations of CBD among machinists
(the group of patients likely to have had the highest beryllium
exposures) to non- machinists, including only CBD patients who had
never smoked. Longitudinal analyses showed significant declines in
some clinical indicators over time since first exposure for
machinists (p <0.01) as well as faster development of illness (p <
0.05), compared to a control group of non-machinists.
---------------------------------------------------------------------------
Treatment of CBD using inhaled and systemic steroid therapy has
been shown to ease symptoms and slow or prevent some aspects of disease
progression. As explained below, these treatments can be most
effectively applied when CBD is diagnosed prior to development of
symptoms. In addition, the forms of treatment that can be used to
manage early-stage CBD have relatively minor side effects on patients,
while systemic steroid treatments required to treat later-stage CBD
often cause severe side effects.
In the public hearing, Dr. Newman and Dr. Maier testified about
their experiences treating patients with CBD at various stages of the
disease. Dr. Newman stated that patients' outcomes depend greatly on
how early they are diagnosed. "So there are those people who are
diagnosed very late in the course of disease where there's little that
we can do to intervene and they are going to die prematurely. There are
those people who may be detected with milder disease where there are
opportunities to intervene" (Document ID 1756, Tr. 132). Both Dr.
Maier and Dr. Newman emphasized the importance of early detection and
diagnosis, stating that removing the patient from exposure and
providing treatment early in the course of the disease can slow or even
halt progression of the disease (Document ID 1756, Tr. 111, 132).
Dr. Maier testified that inhaled steroids can be used to treat
relatively mild symptoms that may occur in early stages of the disease,
such as a cough during exercise (Document ID 1756, Tr. 139). Inhaled
steroids, she stated, are commonly used to treat other health
conditions and have fewer and milder side effects than forms of steroid
treatment that are used to treat more severe forms of CBD (Document ID
1756, Tr. 140). Early detection of CBD helps physicians to properly
treat early-onset symptoms, since appropriate forms of treatment for
early stage CBD can differ from treatments for conditions it is
commonly mistaken for, such as chronic obstructive pulmonary disease
(COPD) and asthma (Document ID 1756, Tr. 140-141).
CBD in later stages is often managed using systemic steroid
treatments such as corticosteroids. In workers with CBD whose beryllium
exposure has ceased, corticosteroid therapy has been shown to control
inflammation, ease symptoms (e.g., difficulty breathing, fever, cough,
and weight loss), and in some cases prevent the development of fibrosis
(Marchand-Adam et al., 2008, Document ID 0370). Thus, although there is
no cure for CBD, properly-timed treatment can lead to CBD regression in
some patients (Sood, 2004, Document ID 1331). Other patients have shown
short-term improvements from corticosteroid treatment, but then
developed serious fibrotic lesions (Marchand-Adam et al., 2008). Ms.
Peggy Mroz, of NJH, discussed the results of the Marchand-Adam et al.
study in the hearing, stating that treatment of CBD using steroids has
been most successful when treatment begins prior to the development of
lung fibrosis (Document ID 1756, Tr. 113). Once fibrosis has developed
in the lungs, corticosteroid treatment cannot reverse the damage (Sood,
2009, Document ID 0456). Persons with late-stage CBD experience severe
respiratory insufficiency and may require supplemental oxygen (Rossman,
1991, Document 1332). Historically, late-stage CBD often ended in death
(NAS, 2008, Document ID 1355). While the use of steroid treatments can
help to reduce the effects of CBD, OSHA is not aware of any studies
showing the effect of these treatments on the frequency of premature
death among patients with CBD.
Treatment with corticosteroids has severe side effects
(Trikudanathan and McMahon, 2008, Document ID 0366; Lipworth, 1999
(0371); Gibson et al., 1996 (1521); Zaki et al., 1987 (1374)). Adverse
effects associated with long-term corticosteroid use include, but are
not limited to: increased risk of opportunistic infections (Lionakis
and Kontoyiannis, 2003, Document ID 0372; Trikudanathan and McMahon,
2008 (0366)); accelerated bone loss or osteoporosis leading to
increased risk of fractures or breaks (Hamida et al., 2011, Document ID
0374; Lehouck et al., 2011 (0355); Silva et al., 2011 (0388); Sweiss et
al., 2011 (0367); Langhammer et al., 2009 (0373)); psychiatric effects
including depression, sleep disturbances, and psychosis (Warrington and
Bostwick, 2006, Document ID 0365; Brown, 2009 (0377)); adrenal
suppression (Lipworth, 1999, Document ID 0371; Frauman, 1996 (0356));
ocular effects including cataracts, ocular hypertension, and glaucoma
(Ballonzoli and Bourcier, 2010, Document ID 0391; Trikudanathan and
McMahon, 2008 (0366); Lipworth, 1999 (0371)); an increase in glucose
intolerance (Trikudanathan and McMahon, 2008, Document ID 0366);
excessive weight gain (McDonough et al., 2008, Document ID 0369; Torres
and Nowson, 2007 (0387); Dallman et al., 2007 (0357); Wolf, 2002
(0354); Cheskin et al., 1999 (0358)); increased risk of atherosclerosis
and other cardiovascular syndromes (Franchimont et al., 2002, Document
ID 0376); skin fragility (Lipworth, 1999, Document ID 0371); and poor
wound healing (de Silva and Fellows, 2010, Document ID 0390).
Based on the above, OSHA considers late-stage CBD to be a material
impairment of health, as it involves permanent damage to the pulmonary
system, causes additional serious adverse health effects, can have
adverse occupational and social consequences, requires treatment that
can cause severe and lasting side effects, and may in some cases cause
premature death.
Furthermore, OSHA has determined that early-stage CBD, an
asymptomatic period during which small lesions and inflammation appear
in the lungs, is also a material impairment of health. OSHA bases this
conclusion on evidence and expert testimony that early-stage CBD is a
measurable change in an individual's state of health that, with and
sometimes without continued exposure, can progress to symptomatic
disease (e.g., Mroz et al., 2009 (1443); 1756, Tr. 131). Thus,
prevention of the earliest stages of CBD will prevent development of
more serious disease. In OSHA's Lead standard, promulgated in 1978, the
Agency stated its position that a "subclinical" health effect may be
regarded as a material impairment of health. In the preamble to that
standard, the Agency said:
OSHA believes that while incapacitating illness and death
represent one extreme of a spectrum of responses, other biological
effects such as metabolic or physiological changes are precursors or
sentinels of disease which should be prevented. . . . Rather than
revealing the beginnings of illness the standard must be selected to
prevent an earlier point of measurable change in the state of health
which is the first significant indicator of possibly more severe ill
health in the future. The basis for this decision is twofold--first,
pathophysiologic changes are early stages in the disease process
which would grow worse with continued exposure and which may include
early effects which even at early stages are irreversible, and
therefore represent material impairment themselves. Secondly,
prevention of pathophysiologic changes will prevent the onset of the
more serious, irreversible and debilitating manifestations of
disease (43 FR 52952, 52954).
Since the Lead rulemaking, OSHA has also found other non-
symptomatic (or sub-clinical) health conditions to be material
impairments of health. In the Bloodborne Pathogens rulemaking, OSHA
maintained that material impairment includes not only workers with
clinically "active" hepatitis from the hepatitis B virus (HBV) but
also includes asymptomatic HBV "carriers" who remain infectious and
are able to put others at risk of serious disease through contact with
body fluids (e.g., blood, sexual contact) (56 FR 64004). OSHA stated:
"Becoming a carrier [of HBV] is a material impairment of health even
though the carrier may have no symptoms. This is because the carrier
will remain infectious, probably for the rest of his or her life, and
any person who is not immune to HBV who comes in contact with the
carrier's blood or certain other body fluids will be at risk of
becoming infected" (56 FR 64004, 64036).
OSHA finds that early-stage CBD is the type of asymptomatic health
effect the Agency determined to be a material impairment of health in
the Lead and Bloodborne Pathogens standards. Early stage CBD involves
lung tissue inflammation without symptoms that can worsen with--or
without--continued exposure. The lung pathology progresses over time
from a chronic inflammatory response to tissue scarring and fibrosis
accompanied by moderate to severe loss in pulmonary function. Early
stage CBD is clearly a precursor of advanced clinical disease,
prevention of which will prevent symptomatic disease. OSHA determined
in the Lead standard that such precursor effects should be considered
material health impairments in their own right, and that the Agency
should act to prevent them when it is feasible to do so. Therefore,
OSHA finds all stages of CBD to be material impairments of health
within the meaning of section 6(b)(5) of the OSH Act (29 U.S.C.
655(b)(5)).
In reviewing OSHA's Lead standard in United Steelworkers of
America, AFL-CIO v. Marshall, 647 F.2d 1189, 1252 (D.C. Cir. 1980)
(Lead I), the D.C. Circuit affirmed that the OSH Act "empowers OSHA to
set a PEL that prevents the subclinical effects of lead that lie on a
continuum shared with overt lead disease." See also AFL-CIO v.
Marshall, 617 F.2d 636, 654 n.83 (D.C. Cir. 1979) (upholding OSHA's
authority to prevent early symptoms of a disease, even if the effects
of the disease are, at that point, reversible). According to the Court,
OSHA only had to demonstrate,
on the basis of substantial evidence, that preventing the subclinical
effects would help prevent the clinical phase of disease (United
Steelworkers of America, AFL-CIO, 647 F.2d at 1252). Thus, OSHA has the
authority to regulate to prevent asymptomatic CBD whether or not it is
properly labeled as a material impairment of health.
OSHA has also determined that exposure to beryllium can cause
beryllium sensitization. Sensitization is a precursor to development of
CBD and an essential step for development of the disease. As discussed
in Section V, Health Effects, only sensitized individuals can develop
CBD (NAS, 2008, Document ID 1355).\25\ As explained above, OSHA has the
authority to promulgate regulations designed to prevent precursors to
material impairments of health. Therefore, OSHA's new beryllium
standards aim to prevent sensitization as well as the development of
CBD and lung cancer. OSHA's risk assessment for sensitization,
presented in section VI, informs the Agency's understanding of what
exposure control measures have been successful in preventing
sensitization, which in turn prevents development of CBD. Therefore,
OSHA addresses sensitization in this section on significance of risk.
---------------------------------------------------------------------------
\25\ In the NPRM, OSHA took no position on whether beryllium
sensitization by itself is a material impairment of health, stating
it was unnecessary to do so as part of this rulemaking. The only
comment on this issue came from Materion, which argued that "BeS
does not constitute a material impairment of health or functional
capacity" (document ID 1958). Because BeS is also a precursor to
CBD, OSHA finds it unnecessary to resolve this issue here.
---------------------------------------------------------------------------
Risk Assessment
As discussed in Section VI, Risk Assessment, the risk assessment
for beryllium sensitization and CBD relied on two approaches: (1)
OSHA's review of epidemiological studies of sensitization and CBD that
contain information on exposures in the range of interest to OSHA (2
μg/m3\ and below), and (2) OSHA's analysis of a NJH data set on
sensitization and CBD in a group of beryllium-exposed machinists in
Cullman, AL.
OSHA's review of the literature includes studies of beryllium-
exposed workers at a Tucson, AZ ceramics plant (Kreiss et al., 1996,
Document ID 1477; Henneberger et al., 2001 (1313); Cummings et al.,
2007 (1369)); a Reading, PA copper-beryllium processing plant (Schuler
et al., 2005, Document ID 0919; Thomas et al., 2009 (0590)); a Cullman,
AL beryllium machining plant (Newman et al., 2001, Document ID 1354;
Kelleher et al., 2001 (1363); Madl et al., 2007 (1056)); an Elmore, OH
metal, alloy, and oxide production plant (Kreiss et al., 1993 Document
ID 1478; Bailey et al., 2010 (0676); Schuler et al., 2012 (0473));
aluminum smelting facilities (Taiwo et al. 2008, Document ID 0621; 2010
(0583); Nilsen et al., 2010 (0460)); and nuclear facilities (Viet et
al., 2000, Document ID 1344; Arjomandi et al., 2010 (1275)).
The published literature on beryllium sensitization and CBD
discussed in section VI shows that the risk of both can be significant
in workplaces where exposures are at or below OSHA's preceding PEL of 2
μg/m3\ (e.g., Kreiss et al., 1996, Document ID 1477; Henneberger et
al., 2001 (1313); Newman et al., 2001 (1354); Schuler et al., 2005
(0919), 2012 (0473); Madl et al., 2007 (1056)). For example, in the
Tucson ceramics plant mentioned above, Kreiss et al. (1996) reported
that eight (5.9 percent) \26\ of the 136 workers tested in 1992 were
sensitized, six (4.4 percent) of whom were diagnosed with CBD. In
addition, of 77 Tucson workers hired prior to 1992 who were tested in
1998, eight (10.4 percent) were sensitized and seven of these (9.7
percent) were diagnosed with CBD (Henneberger et al., 2001, Document ID
1313). Full-shift area samples showed most airborne beryllium levels
below the preceding PEL: 76 percent of area samples collected between
1983 and 1992 were at or below 0.1 μg/m3\ and less than 1 percent
exceeded 2 μg/m3\; short-term breathing zone measurements collected
between 1981 and 1992 had a median of 0.3 μg/m3\; and personal
lapel samples collected at the plant beginning in 1991 had a median of
0.2 μg/m3\ (Kreiss et al., 1996).
---------------------------------------------------------------------------
\26\ Although OSHA reports percentages to indicate the risks of
sensitization and CBD in this section, the benchmark OSHA typically
uses to demonstrate significant risk, as discussed earlier, is
greater than or equal to 1 in 1,000 workers. One in 1,000 workers is
equivalent to 0.1 percent. Therefore, any value of 0.1 percent or
higher when reporting occurrence of a health effect is considered by
OSHA to indicate a significant risk.
---------------------------------------------------------------------------
Results from the Elmore, OH beryllium metal, alloy, and oxide
production plant and the Cullman, AL machining facility also showed
significant risk of sensitization and CBD among workers with exposures
below the preceding TWA PEL. Schuler et al. (2012, Document ID 0473)
found 17 cases of sensitization (8.6 percent) among Elmore, OH workers
within the first three quartiles of LTW average exposure (198 workers
with LTW average total mass exposures lower than 1.1 μg/m3\) and 4
cases of CBD (2.2 percent) within those quartiles of LTW average
exposure (183 workers with LTW average total mass exposures lower than
1.07 μg/m3\; note that follow-up time of up to 6 years for all
study participants was very short for development of CBD). At the
Cullman, AL machining facility, Newman et al. (2001, Document ID 1354)
reported 22 (9.4 percent) sensitized workers among 235 tested in 1995-
1999, 13 of whom were diagnosed with CBD within the study period.
Personal lapel samples collected between 1980 and 1999 indicate that
median exposures were generally well below the preceding PEL (<=0.35
μg/m3\ in all job titles except maintenance (median 3.1 μg/m3\
during 1980-1995) and gas bearings (1.05 μg/m3\ during 1980-1995)).
Although risk will be reduced by compliance with the new TWA PEL,
evidence in the epidemiological studies reviewed in section VI, Risk
Assessment, shows that significant risk of sensitization and CBD could
remain in workplaces with exposures as low as the new action level of
0.1 μg/m3\. For example, Schuler et al. (2005, Document ID 0919)
reported substantial prevalences of sensitization (6.5 percent) and CBD
(3.9 percent) among 152 workers at the Reading, PA facility screened
with the BeLPT in 2000. These results showed significant risk at this
facility, even though airborne exposures were primarily below both the
preceding and final TWA PELs due to the low percentage of beryllium in
the metal alloys used (median general area samples <=0.1 μg/m3\,
97% < 0.5 μg/m3\; 93% of personal lapel samples below the new TWA
PEL of 0.2 μg/m3\). The only group of workers with no cases of
sensitization or CBD, a group of 26 office administration workers, was
the group with exposures below the new action level of 0.1 μg/m3\
(median personal sample 0.01 μg/m3\, range <0.01-0.06 μg/m3\)
(Schuler et al., 2005). The Schuler et al. (2012, Document ID 0473)
study of short-term workers in the Elmore, OH facility found three
cases (4.6%) of sensitization among 66 workers with total mass LTW
average exposures below 0.1 μg/m3\. All three of these sensitized
workers had LTW average exposures of approximately 0.09 μg/m3\.
Furthermore, cases of sensitization and CBD continued to arise in
the Cullman, AL machining plant after control measures implemented
beginning in 1995 brought median airborne exposures below 0.2 μg/
m3\ (personal lapel samples between 1996 and 1999 in machining jobs
had a median of 0.16 μg/m3\ and the median was 0.08 μg/m3\ in
non-machining jobs)
(Madl et al., 2007, Document ID 1056, Table IV). At the time that
Newman et al. (2001, Document ID 1354) reviewed the results of BeLPT
screenings conducted in 1995-1999, a subset of 60 workers had been
employed at the plant for less than a year and had therefore benefitted
to some extent from the exposure reductions. Four (6.7 percent) of
these workers were found to be sensitized, of whom two were diagnosed
with CBD and one with probable CBD (Newman et al., 2001). A later study
by Madl. et al. (2007, Document ID 1056) reported seven sensitized
workers who had been hired between 1995 and 1999, of whom four had
developed CBD as of 2005 (Table II; total number of workers hired
between 1995 and 1999 not reported).
The enhanced industrial hygiene programs that have proven effective
in several facilities demonstrate the importance of minimizing both
airborne exposure and dermal contact to effectively reduce risk of
sensitization and CBD. Exposure control programs that have used a
combination of engineering controls, PPE, and stringent housekeeping
measures to reduce workers' airborne exposure and dermal contact have
substantially lowered risk of sensitization among newly-hired
workers.\27\ Of 97 workers hired between 2000 and 2004 in the Tucson,
AZ plant after the introduction of a comprehensive program which
included the use of respiratory protection (1999) and latex gloves
(2000), one case of sensitization was identified (1 percent) (Cummings
et al., 2007, Document ID 1369). In Elmore, OH, where all workers were
required to wear respirators and skin PPE in production areas beginning
in 2000-2001, the estimated prevalence of sensitization among workers
hired after these measures were put in place was around 2 percent
(Bailey et al., 2010, Document ID 0676). In the Reading, PA facility,
after workers' exposures were reduced to below 0.1 μg/m3\ and PPE
to prevent dermal contact was instituted, only one (2.2 percent) of 45
workers hired was sensitized (Thomas et al. 2009, Document ID 0590).
And, in the aluminum smelters discussed by Taiwo et al. (2008, Document
ID 0621), where available exposure samples from four plants indicated
median beryllium levels of about 0.1 μg/m3\ or below (measured as
an 8-hour TWA) and workers used respiratory and dermal protection,
confirmed cases of sensitization were rare (zero or one case per
location).
---------------------------------------------------------------------------
\27\ As discussed in Section V, Health Effects, beryllium
sensitization can occur from dermal contact with beryllium.
---------------------------------------------------------------------------
OSHA notes that the studies on recent programs to reduce workers'
risk of sensitization and CBD were conducted on populations with very
short exposure and follow-up time. Therefore, they could not adequately
address the question of how frequently workers who become sensitized in
environments with extremely low airborne exposures (median <0.1 μg/
m3\) develop CBD. Clinical evaluation for CBD was not reported for
sensitized workers identified in the studies examining the post-2000
worker cohorts with very low exposures in Tucson, Reading, and Elmore
(Cummings et al. 2007, Document ID 1369; Thomas et al. 2009, (0590);
Bailey et al. 2010, (0676)). In Cullman, however, two of the workers
with CBD had been employed for less than a year and worked in jobs with
very low exposures (median 8-hour personal sample values of 0.03-0.09
μg/m3\) (Madl et al., 2007, Document ID 1056, Table III). The body
of scientific literature on occupational beryllium disease also
includes case reports of workers with CBD who are known or believed to
have experienced minimal beryllium exposure, such as a worker employed
only in shipping at a copper-beryllium distribution center (Stanton et
al., 2006, Document ID 1070), and workers employed only in
administration at a beryllium ceramics facility (Kreiss et al., 1996,
Document ID 1477). Therefore, there is some evidence that cases of CBD
can occur in work environments where beryllium exposures are quite low.
In summary, the epidemiological literature on beryllium
sensitization and CBD that OSHA's risk assessment relied on show
sufficient occurrence of sensitization and CBD to be considered
significant within the meaning of the OSH Act. These demonstrated risks
are far in excess of 1 in 1,000 among workers who had full-shift
exposures well below the preceding TWA PEL of 2 μg/m3\ and workers
who had median full-shift exposures down to the new action level of 0.1
μg/m3\. These health effects occurred among populations of workers
whose follow-up time was much less than 45 years. As stated earlier,
OSHA is interested in the risk associated with a 45-year (i.e., working
lifetime) exposure. Because CBD often develops over the course of years
following sensitization, the risk of CBD that would result from 45
years of occupational exposure to airborne beryllium is likely to be
higher than the prevalence of CBD observed among these workers.\28\ In
either case, based on these studies, the risks to workers from long-
term exposure at the preceding TWA PEL and below are clearly
significant. OSHA's review of epidemiological studies further showed
that worker protection programs that effectively reduced the risk of
beryllium sensitization and CBD incorporated engineering controls, work
practice controls, and personal protective equipment (PPE) that reduce
workers' airborne beryllium exposure and dermal contact with beryllium.
OSHA has therefore determined that an effective worker protection
program should incorporate both airborne exposure reduction and dermal
protection provisions.
---------------------------------------------------------------------------
\28\ This point was emphasized by members of the scientific peer
review panel for OSHA's Preliminary Risk Assessment (see the NPRM
preamble at section VII).
---------------------------------------------------------------------------
OSHA's conclusions on significance of risk at the final PEL and
action level are further supported by its analysis of the data set
provided to OSHA by NJH from which OSHA derived additional information
on sensitization and CBD at exposure levels of interest. The data set
describes a population of 319 beryllium-exposed workers at a Cullman,
AL machining facility. It includes exposure samples collected between
1980 and 2005, and has updated work history and screening information
through 2003. Seven (2.2 percent) workers in the data set were reported
as sensitized only. Sixteen (5.0 percent) workers were listed as
sensitized and diagnosed with CBD upon initial clinical evaluation.
Three (0.9 percent) workers, first shown to be sensitized only, were
later diagnosed with CBD. The data set includes workers exposed at
airborne beryllium levels near the new TWA PEL of 0.2 μg/m3\, and
extensive exposure data collected in workers' breathing zones, as is
preferred by OSHA. Unlike the Tucson, Reading, and Elmore facilities
after 2000, respirator use was not generally required for workers at
the Cullman facility. Thus, analysis of this data set shows the risk
associated with varying levels of airborne exposure rather than
estimating exposure accounting for respirators. Also unlike the Tucson,
Elmore, and Reading facilities, glove use was not reported to be
mandatory in the Cullman facility. Therefore, OSHA believes reductions
in risk at the Cullman facility to be the result of airborne exposure
control, rather than the combination of airborne and dermal exposure
controls used at other facilities.
OSHA analyzed the prevalence of beryllium sensitization and CBD
among
workers at the Cullman facility who were exposed to airborne beryllium
levels at and below the preceding TWA PEL of 2 μg/m3\. In addition,
a statistical modeling analysis of the NJH Cullman data set was
conducted under contract with Dr. Roslyn Stone of the University of
Pittsburgh Graduate School of Public Heath, Department of
Biostatistics. OSHA summarizes these analyses briefly below, and in
more detail in section VI, Risk Assessment and in the background
document (Risk Analysis of the NJH Data Set from the Beryllium
Machining Facility in Cullman, Alabama--CBD and Sensitization, OSHA,
2016).
Tables VII-1 and VII-2 below present the prevalence of
sensitization and CBD cases across several categories of lifetime-
weighted (LTW) average and highest-exposed job (HEJ) exposure at the
Cullman facility. The HEJ exposure is the exposure level associated
with the highest-exposure job and time period experienced by each
worker. The columns "Total" and "Total percent" refer to all
sensitized workers in the data set, including workers with and without
a diagnosis of CBD.
Table VII-1--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized
LTW average exposure (μg/m3\) Group size only CBD Total Total (%) CBD (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080............................................... 91 1 1 2 2.2 1.0
0.081-0.18.............................................. 73 2 4 6 8.2 5.5
0.19-0.51............................................... 77 0 6 6 7.8 7.8
0.51-2.15............................................... 78 4 8 12 15.4 10.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Risk Assessment.
Table VII-2--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized
HEJ exposure (μg/m3\) Group size only CBD Total Total (%) CBD (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086............................................... 86 1 0 1 1.2 0.0
0.091-0.214............................................. 81 1 6 7 8.6 7.4
0.387-0.691............................................. 76 2 9 11 14.5 11.8
0.954-2.213............................................. 76 3 4 7 9.2 5.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Risk Assessment.
The preceding PEL of 2 μg/m3\ is close to the upper bound of
the highest quartile of LTW average (0.51-2.15 μg/m3\) and HEJ
(0.954-2.213 μg/m3\) exposure levels. In the highest quartile of
LTW average exposure, there were 12 cases of sensitization (15.4
percent), including eight (10.3 percent) diagnosed with CBD. Notably,
the Cullman workers had been exposed to beryllium dust for considerably
less than 45 years at the time of testing. A high prevalence of
sensitization (9.2 percent) and CBD (5.3 percent) is seen in the top
quartile of HEJ exposure as well, with even higher prevalences in the
third quartile (0.387-0.691 μg/m3\).\29\
---------------------------------------------------------------------------
\29\ This exposure-response pattern, wherein higher rates of
response are seen in workers with lower exposures, is sometimes
attributed to a "healthy worker effect" or to exposure
misclassification, as discussed in this preamble at section VI, Risk
Assessment.
---------------------------------------------------------------------------
The new TWA PEL of 0.2 μg/m3\ is close to the upper bound of
the second quartile of LTW average (0.81-0.18 μg/m3\) and HEJ
(0.091-0.214 μg/m3\) exposure levels and to the lower bound of the
third quartile of LTW average (0.19-0.50 μg/m3\) exposures. The
second quartile of LTW average exposure shows a high prevalence of
beryllium-related health effects, with six workers sensitized (8.2
percent), of whom four (5.5 percent) were diagnosed with CBD. The
second quartile of HEJ exposure also shows a high prevalence of
beryllium-related health effects, with seven workers sensitized (8.6
percent), of whom six (7.4 percent) were diagnosed with CBD. Among six
sensitized workers in the third quartile of LTW average exposures, all
were diagnosed with CBD (7.8 percent). The prevalence of CBD among
workers in these quartiles was approximately 5-8 percent, and overall
sensitization (including workers with and without CBD) was about 8-9
percent. OSHA considers these rates to be evidence that the risks of
developing sensitization and CBD are significant among workers exposed
at and below the preceding TWA PEL, and even below the new TWA PEL.
These risks are much higher than the benchmark for significant risk of
1 in 1,000. Much lower prevalences of sensitization and CBD were found
among workers with exposure levels less than or equal to about 0.08
μg/m3\, although these risks are still significant. Two sensitized
workers (2.2 percent), including one case of CBD (1.0 percent), were
found among workers with LTW average exposure levels less than or equal
to 0.08 μg/m3\. One case of sensitization (1.2 percent) and no
cases of CBD were found among workers with HEJ exposures of at most
0.086 μg/m3\. Strict control of airborne exposure to levels below
0.1 μg/m3\ using engineering and work practice controls can,
therefore, substantially reduce risk of sensitization and CBD. Although
OSHA recognizes that maintaining exposure levels below 0.1 μg/m3\
may not be feasible in some operations (see this preamble at section
VIII, Summary of the Economic Analysis and Regulatory Flexibility
Analysis), the Agency finds that workers in facilities that meet the
action level of 0.1 μg/m3\ will face lower risks of sensitization
and CBD than workers in facilities that cannot meet the action level.
Table VII-3 below presents the prevalence of sensitization and CBD
cases across cumulative exposure quartiles, based on the same Cullman
data used to derive Tables 1 and 2. Cumulative exposure is the sum of a
worker's exposure across the duration of his or her employment.
Table VII-3--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized
Cumulative exposure (μg/m3\-yrs) Group size only CBD Total Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147............................................... 81 2 2 4 4.9 2.5
0.148-1.467............................................. 79 0 2 2 2.5 2.5
1.468-7.008............................................. 79 3 8 11 13.9 8.0
7.009-61.86............................................. 80 2 7 9 11.3 8.8
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Risk Assessment.
A 45-year working lifetime of occupational exposure at the
preceding PEL would result in 90 μg/m3\-years of exposure, a value
far higher than the cumulative exposures of workers in this data set,
who worked for periods of time less than 45 years and whose exposure
levels were mostly well below the previous PEL. Workers with 45 years
of exposure to the new TWA PEL of 0.2 μg/m3\ would have a
cumulative exposure (9 μg/m3\-years) in the highest quartile for
this worker population. As with the average and HEJ exposures, the
greatest risk of sensitization and CBD appears at the higher exposure
levels (<1.467 μg/m3\-years). The third cumulative quartile, at
which a sharp increase in sensitization and CBD appears, is bounded by
1.468 and 7.008 μg/m3\-years. This is equivalent to 0.73-3.50 years
of exposure at the preceding PEL of 2 μg/m3\, or 7.34-35.04 years
of exposure at the new TWA PEL of 0.2 μg/m3\. Prevalence of both
sensitization and CBD is substantially lower in the second cumulative
quartile (0.148-1.467 μg/m3\-years). This is equivalent to
approximately 0.7 to 7 years at the new TWA PEL of 0.2 μg/m3\, or
1.5 to 15 years at the action level of 0.1 μg/m3\. Risks at all
levels of cumulative exposure presented in Table 3 are significant.
These findings support OSHA's determination that maintaining exposure
levels below the new TWA PEL will help to protect workers against risk
of beryllium sensitization and CBD. Moreover, while OSHA finds that
significant risk remains at the PEL, OSHA's analysis shows that further
reductions of risk will ensue if employers are able to reduce exposure
to the action level or even below.
Lung Cancer
Lung cancer, a frequently fatal disease, is a well-recognized
material impairment of health. OSHA has determined that beryllium
causes lung cancer based on an extensive review of the scientific
literature regarding beryllium and cancer. This review included an
evaluation of the human epidemiological, animal cancer, and mechanistic
studies described in section V, Health Effects. OSHA's conclusion that
beryllium is carcinogenic is supported by the findings of expert public
health and governmental organizations such as the International Agency
for Research on Cancer (IARC), which has determined beryllium and its
compounds to be carcinogenic to humans (Group 1 category) (IARC, 2012,
Document ID 0650); the National Toxicology Program (NTP), which
classifies beryllium and its compounds as known carcinogens (NTP, 2014,
Document ID 0389); and the Environmental Protection Agency (EPA), which
considers beryllium to be a probable human carcinogen (EPA, 1998,
Document ID 0661).
OSHA's review of epidemiological studies of lung cancer mortality
among beryllium workers found that most of them did not characterize
exposure levels sufficiently to evaluate the risk of lung cancer at the
preceding and new TWA PELs. However, as discussed in this preamble at
section V, Health Effects and section VI, Risk Assessment, Schubauer-
Berigan et al. published a quantitative risk assessment based on
beryllium exposure and lung cancer mortality among 5,436 male workers
first employed at beryllium processing plants in Reading, PA, Elmore,
OH, and Hazleton, PA, prior to 1970 (Schubauer-Berigan et al., 2011,
Document ID 1265). This risk assessment addresses important sources of
uncertainty for previous lung cancer analyses, including the sole prior
exposure-response analysis for beryllium and lung cancer, conducted by
Sanderson et al. (2001) on workers from the Reading plant alone.
Workers from the Elmore and Hazleton plants who were added to the
analysis by Schubauer-Berigan et al. were, in general, exposed to lower
levels of beryllium than those at the Reading plant. The median worker
from Hazleton had a LTW average exposure of less than 1.5 μg/m3\,
while the median worker from Elmore had a LTW average exposure of less
than 1 μg/m3\. The Elmore and Hazleton worker populations also had
fewer short-term workers than the Reading population. Finally, the
updated cohorts followed the worker populations through 2005,
increasing the length of follow-up time compared to the previous
exposure-response analysis. For these reasons, OSHA based the
preliminary risk assessment for lung cancer on the Schubauer-Berigan
risk analysis.
Schubauer-Berigan et al. (2011, Document ID 1265) analyzed the data
set using a variety of exposure-response modeling approaches, described
in this preamble at section VI, Risk Assessment. The authors found that
lung cancer mortality risk was strongly and significantly correlated
with mean, cumulative, and maximum measures of workers' exposure to
beryllium (all of the models reported in the study). They selected the
best-fitting models to generate risk estimates for male workers with a
mean exposure of 0.5 μg/m3\ (the current NIOSH Recommended Exposure
Limit for beryllium). In addition, they estimated the daily weighted
average exposure that would be associated with an excess lung cancer
mortality risk of one in one thousand (.005 μg/m3\ to .07 μg/
m3\ depending on model choice). At OSHA's request, the authors also
estimated excess lifetime risks for workers with mean exposures at the
preceding TWA PEL of 2 μg/m3\ as well as at each of the alternate
TWA PELs that were under consideration: 1 μg/m3\, 0.2 μg/m3\,
and 0.1 μg/m3\. Table VII-4 presents the estimated excess risk of
lung cancer mortality associated with various levels of beryllium
exposure, based on the final models presented in Schubauer-Berigan et
al's risk assessment.\30\
---------------------------------------------------------------------------
\30\ The estimates for lung cancer represent "excess" risks in
the sense that they reflect the risk of dying from lung cancer over
and above the risk of dying from lung cancer faced by those who are
not occupationally exposed to beryllium.
Table VII-4--Excess Risk of Lung Cancer Mortality per 1,000 Male Workers at Alternate PELs (based on Schubauer-
Berigan et al., 2011)
----------------------------------------------------------------------------------------------------------------
Mean exposure
Exposure-response model -------------------------------------------------------------------------------
0.1 μg/m3\ 0.2 μg/m3\ 0.5 μg/m3\ 1 μg/m3\ 2 μg/m3\
----------------------------------------------------------------------------------------------------------------
Best monotonic PWL-all workers.. 7.3 15 45 120 140
Best monotonic PWL--excluding 3.1 6.4 17 39 61
professional and asbestos
workers........................
Best categorical--all workers... 4.4 9 25 59 170
Best categorical--excluding 1.4 2.7 7.1 15 33
professional and asbestos
workers........................
Power model--all workers........ 12 19 30 40 52
Power model--excluding 19 30 49 68 90
professional and asbestos
workers........................
----------------------------------------------------------------------------------------------------------------
Source: Schubauer-Berigan, Document ID 0521, pp. 6-10.
The lowest estimate of excess lung cancer deaths from the six final
models presented by Schubauer-Berigan et al. is 33 per 1,000 workers
exposed at a mean level of 2 μg/m3\, the preceding TWA PEL. Risk
estimates as high as 170 lung cancer deaths per 1,000 result from the
other five models presented. Regardless of the model chosen, the excess
risk of about 33 to 170 per 1,000 workers is clearly significant,
falling well above the level of risk the Supreme Court indicated a
reasonable person might consider acceptable (see Benzene, 448 U.S. at
655). The new PEL of 0.2 μg/m3\ is expected to reduce these risks
significantly, to somewhere between 2.7 and 30 excess lung cancer
deaths per 1,000 workers. At the new action level of 0.1 μg/m3\,
risk falls within the range of 1.4 to 19 excess lung cancer deaths.
These risk estimates still fall above the threshold of 1 in 1,000 that
OSHA considers clearly significant. However, the Agency believes the
lung cancer risks should be regarded as less certain than the risk
estimates for CBD and sensitization discussed previously. While the
risk estimates for CBD and sensitization at the preceding and new TWA
PELs were determined from exposure levels observed in occupational
studies, the lung cancer risks were extrapolated from much higher
exposure levels.
Conclusions
As discussed throughout this section, OSHA used the best available
scientific evidence to identify adverse health effects of occupational
beryllium exposure, and to evaluate exposed workers' risk of these
impairments. The Agency reviewed extensive epidemiological and
experimental research pertaining to adverse health effects of
occupational beryllium exposure, including lung cancer, CBD, and
beryllium sensitization, and has evaluated the risk of these effects
from exposures allowed under the preceding and new TWA PELs. The Agency
has, additionally, reviewed the medical literature, as well as previous
policy determinations and case law regarding material impairment of
health, and has determined that CBD, at all stages, and lung cancer
constitute material health impairments.
OSHA has determined that long-term exposure to beryllium at the
preceding TWA PEL would pose a risk of CBD and lung cancer greater than
the risk of 1 per 1,000 exposed workers the Agency considers clearly
significant, and that adoption of the new TWA PEL, action level, and
dermal protection requirements of the final standards will
substantially reduce this risk. OSHA believes substantial evidence
supports its determinations, including its choices of the best
available published studies on which to base its risk assessment, its
examination of the prevalence of sensitization and CBD among workers
with exposure levels comparable to the preceding TWA PEL and new TWA
PEL in the NJH data set, and its selection of the Schubauer-Berigan QRA
to form the basis for its lung cancer risk estimates. The previously-
described analyses demonstrate that workers with occupational exposure
to airborne beryllium at the preceding PEL face risks of developing CBD
and dying from lung cancer that far exceed the value of 1 in 1,000 used
by OSHA as a benchmark of clearly significant risk. Furthermore, OSHA's
risk assessment indicates that risk of CBD and lung cancer can be
significantly reduced by reduction of airborne exposure levels, and
that dermal protection measures will additionally help reduce risk of
sensitization and, therefore, of CBD.
OSHA's risk assessment also indicates that, despite the reduction
in risk expected with the new PEL, the risks of CBD and lung cancer to
workers with average exposure levels of 0.2 μg/m3\ are still
significant and could extend down to 0.1 μg/m3\, although there is
greater uncertainty in this finding for 0.1 μg/m3\ since there is
less information available on populations exposed at and below this
level. Although significant risk remains at the new TWA PEL, OSHA is
also required to consider the technological and economic feasibility of
the standard in determining exposure limits. As explained in Section
VIII, Summary of the Final Economic Analysis and Final Regulatory
Flexibility Analysis, OSHA determined that the new TWA PEL of 0.2
μg/m3\ is both technologically and economically feasible in the
general industry, construction, and shipyard sectors. OSHA was unable
to demonstrate, however, that a lower TWA PEL of 0.1 μg/m3\ would
be technologically feasible. Therefore, OSHA concludes that, in setting
a TWA PEL of 0.2 μg/m3\, the Agency is reducing the risk to the
extent feasible, as required by the OSH Act (see section II, Pertinent
Legal Authority). In this context, the Agency finds that the action
level of 0.1 μg/m3\, dermal protection requirements, and other
ancillary provisions of the final rule are critically important in
reducing the risk of sensitization, CBD, and lung cancer among workers
exposed to beryllium. Together, these provisions, along with the new
TWA PEL of 0.2 μg/m3\, will substantially reduce workers' risk of
material impairment of health from occupational beryllium exposure.
VIII. Summary of the Final Economic Analysis and Final Regulatory
Flexibility Analysis
A. Introduction
OSHA's Final Economic Analysis and Final Regulatory Flexibility
Analysis (FEA) addresses issues related to the costs, benefits,
technological and economic feasibility, and the economic impacts
(including impacts on small entities) of this final beryllium rule and
evaluates regulatory alternatives to the final rule. Executive Orders
13563 and
12866 direct agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, and public health and safety effects;
distributive impacts; and equity). Executive Order 13563 emphasized the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility. The full FEA has
been placed in OSHA rulemaking docket OSHA-H005C-2006-0870. This rule
is an economically significant regulatory action under Sec. 3(f)(1) of
Executive Order 12866 and has been reviewed by the Office of
Information and Regulatory Affairs in the Office of Management and
Budget, as required by executive order.
The purpose of the FEA is to:
Identify the establishments and industries potentially
affected by the final rule;
Estimate current exposures and the technologically
feasible methods of controlling these exposures;
Estimate the benefits resulting from employers coming into
compliance with the final rule in terms of reductions in cases of lung
cancer, chronic beryllium disease;
Evaluate the costs and economic impacts that
establishments in the regulated community will incur to achieve
compliance with the final rule;
Assess the economic feasibility of the final rule for
affected industries; and
Assess the impact of the final rule on small entities
through a Final Regulatory Flexibility Analysis (FRFA), to include an
evaluation of significant regulatory alternatives to the final rule
that OSHA has considered.
Significant Changes to the FEA Between the Proposed Standards and the
Final Standards
OSHA made changes to the Preliminary Economic Analysis (PEA) for
several reasons:
Changes to the rule, summarized in Section I of the
preamble and discussed in detail in the Summary and Explanation;
Comments on the PEA;
Updates of economic data; and
Recognition of errors in the PEA.
OSHA revised its technological and economic analysis in response to
these changes and to comments received on the NPRM. The FEA contains
some costs that were not included in the PEA and updates data to use
more recent data sources and, in some cases, revised methodologies.
Detailed discussions of these changes are included in the relevant
sections throughout the FEA.
The Final Economic Analysis contains the following chapters:
Chapter I. Introduction
Chapter II. Market Failure and the Need for Regulation
Chapter III. Profile of Affected Industries
Chapter IV. Technological Feasibility
Chapter V. Costs of Compliance
Chapter VI. Economic Feasibility Analysis and Regulatory Flexibility
Determination
Chapter VII. Benefits and Net Benefits
Chapter VIII. Regulatory Alternatives
Chapter IX. Final Regulatory Flexibility Analysis
Table VIII-1 provides a summary of OSHA's best estimate of the
costs and benefits of the final rule using a discount rate of 3
percent. As shown, the final rule is estimated to prevent 90 fatalities
and 46 beryllium-related illnesses annually once it is fully effective,
and the estimated cost of the rule is $74 million annually. Also as
shown in Table VIII-1, the discounted monetized benefits of the final
rule are estimated to be $561 million annually, and the final rule is
estimated to generate net benefits of $487 million annually. Table
VIII-1 also presents the estimated costs and benefits of the final rule
using a discount rate of 7 percent.
Table VIII-1--Annualized Benefits, Costs and Net Benefits of OSHA's
Final Beryllium Standard
[3 Percent Discount Rate, 2015 dollars]
------------------------------------------------------------------------
------------------------------------------------------------------------
Annualized Costs:
Control Costs......................................... $12,269,190
Rule Familiarization.................................. 180,158
Exposure Assessment................................... 13,748,676
Regulated Areas....................................... 884,106
Beryllium Work Areas.................................. 129,648
Medical Surveillance.................................. 7,390,958
Medical Removal....................................... 1,151,058
Written Exposure Control Plan......................... 2,339,058
Protective Work Clothing & Equipment.................. 1,985,782
Hygiene Areas and Practices........................... 2,420,584
Housekeeping.......................................... 22,763,595
Training.............................................. 8,284,531
Respirators........................................... 320,885
---------------
Total Annualized Costs (Point Estimate)........... 73,868,230
Annual Benefits: Number of Cases Prevented:
Fatal Lung Cancers (Midpoint Estimate)................ 4
Fatal Chronic Beryllium Disease....................... 86
Beryllium-Related Mortality........................... 90
Beryllium Morbidity................................... 46
Monetized Annual Benefits (Midpoint Estimate)......... $560,873,424
Net Benefits:
Net Benefits.......................................... $487,005,194
------------------------------------------------------------------------
Sources: US DOL, OSHA, Directorate of Standards and Guidance, Office of
Regulatory Analysis
The remainder of this section (Section VIII) of the preamble is
organized as follows:
B. Market Failure and the Need for Regulation
C. Profile of Affected Industries
D. Technological Feasibility
E. Costs of Compliance
F. Economic Feasibility Analysis and Regulatory Flexibility
Determination
G. Benefits and Net Benefits
H. Regulatory Alternatives
I. Final Regulatory Flexibility Analysis.
B. Market Failure and the Need for Regulation
Employees in work environments addressed by the final beryllium
rule are exposed to a variety of significant hazards that can and do
cause serious injury and death. As described in Chapter II of the FEA
in support of the final rule, OSHA concludes there is a demonstrable
failure of private markets to protect workers from exposure to
unnecessarily high levels beryllium and that private markets, as well
as information dissemination programs, workers' compensation systems,
and tort liability options, each may fail to protect workers from
beryllium exposure, resulting in the need for a more protective OSHA
beryllium rule.
After carefully weighing the various potential advantages and
disadvantages of using a regulatory approach to improve upon the
current situation, OSHA concludes that, in the case of beryllium
exposure, the final mandatory standards represent the best choice for
reducing the risks to employees.
C. Profile of Affected Industries
Chapter III of the FEA presents profile data for industries
potentially affected by the final beryllium rule. This Chapter provides
the background data used throughout the remainder of the FEA including
estimates of what industries are affected, and their economic and
beryllium exposure characteristics. OSHA identified the following
application groups as affected by the standard:
Beryllium Production
Beryllium Oxide Ceramics and Composites
Nonferrous Foundries
Secondary Smelting, Refining, and Alloying
Precision Turned Products
Copper Rolling, Drawing, and Extruding
Fabrication of Beryllium Alloy Products
Welding
Dental Laboratories
Aluminum Production
Coal-Fired Electric Power Generation
Abrasive Blasting
Table VIII-3 shows the affected industries by application group and
selected economic characteristics of these affected industries. Table
VIII-4 provides industry-by-industry estimates of current exposure.
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D. Technological Feasibility of the Final Standard on Occupational
Exposure to Beryllium
The OSH Act requires OSHA to demonstrate that a proposed health
standard is technologically feasible (29 U.S.C. 655(b)(5)). As
described in the preamble to the final rule (see Section II, Pertinent
Legal Authority), technological feasibility has been interpreted
broadly to mean "capable of being done" (Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509-510 (1981) ("Cotton Dust")). A standard is
technologically feasible if the protective measures it requires already
exist, can be brought into existence with available technology, or can
be created with technology that can reasonably be expected to be
developed, i.e., technology that "looms on today's horizon" (United
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1272 (D.C.
Cir. 1980) ("Lead I"); Amer. Iron & Steel Inst. v. OSHA, 939 F.2d
975, 980 (D.C. Cir. 1991) ("Lead II"); AFL-CIO v. Brennan, 530 F.2
109, 121 (3rd Cir. 1975)). Courts have also interpreted technological
feasibility to mean that, for health standards, a typical firm in each
affected industry will reasonably be able to implement engineering and
work practice controls that can reduce workers' exposures to meet the
permissible exposure limit in most operations most of the time, without
reliance on respiratory protection (see Lead I, 647 F.2d at 1272; Lead
II, 939 F.2d at 990).
OSHA's technological feasibility analysis is presented in Chapter
IV of the FEA. The technological feasibility analysis identifies the
affected industries and application groups in which employees can
reasonably be expected to be exposed to beryllium, summarizes the
available air sampling data used to develop employee exposure profiles,
and provides descriptions of engineering controls and other measures
employers can take to reduce their employees' exposures to beryllium.
For each affected industry sector or application group, OSHA provides
an assessment of the technological feasibility of compliance with the
final permissible exposure limit (PEL) of 0.2 μg/m3\ as an 8-hour
TWA and a 15-minute short-term exposure limit (STEL) of 2.0 μg/m3\.
The technological feasibility analysis covers twelve application
groups that correspond to specific industries or production processes
that involve the potential for occupational exposures to materials
containing beryllium and that OSHA has determined fall within the scope
of this final beryllium standard. Within each of these application
groups, exposure profiles have been developed to characterize the
distribution of the available exposure measurements by job title or
group of jobs. Each section includes descriptions of existing, or
baseline, engineering controls for operations that generate beryllium
exposure. For those job groups in which current exposures were found to
exceed the final PEL, OSHA identifies and describes additional
engineering and work practice controls that can be implemented to
reduce exposure and achieve compliance with the final PEL. For each
application group or industry, a final determination is made regarding
the technological feasibility of achieving the proposed permissible
exposure limits based on the use of engineering and work practice
controls and without reliance on the use of respiratory protection. The
determination is made based on the legal standard of whether the PEL
can be achieved for most operations most of the time using such
controls. In a separate chapter on short-term exposures, OSHA also
analyzes the feasibility of achieving compliance with the Short-Term
Exposure Limit (STEL).
The analysis is based on the best evidence currently available to
OSHA, including a comprehensive review of the industrial hygiene
literature, National Institute for Occupational Safety and Health
(NIOSH) Health Hazard Evaluations and case studies of beryllium
exposure, site visits conducted by an OSHA contractor (Eastern Research
Group (ERG)), and inspection data from OSHA's Integrated Management
Information System (IMIS) and OSHA's Information System (OIS). OSHA
also obtained information on beryllium production processes, worker
exposures, and the effectiveness of existing control measures from
Materion Corporation, the primary beryllium producer in the United
States, interviews with industry experts, and comments submitted to the
rulemaking docket in response to the Notice of Proposed Rulemaking and
informal public hearings. All of this evidence is in the rulemaking
record.
The twelve application groups are:
Primary Beryllium Production,
Beryllium Oxide Ceramics and Composites,
Nonferrous Foundries,
Secondary Smelting, Refining, and Alloying, Including
Handling of Scrap and Recycled Materials,
Precision Turned Products,
Copper Rolling, Drawing, and Extruding,
Fabrication of Beryllium Alloy Products,
Welding,
Dental Laboratories,
Abrasive Blasting,
Coal-Fired Electric Power Generation,
Aluminum Production
For discussion purposes, the twelve application groups are divided
into four general categories based on the distribution of exposures in
the exposure profiles: (1) Application groups in which baseline
exposures for most jobs are already at or below the final PEL of 0.2
μg/m3\; (2) application groups in which baseline exposures for one
or more jobs exceed the final PEL of 0.2 μg/m3\, but additional
controls have been identified that could achieve exposures at or below
the final PEL for most of the operations most of the time; (3)
application groups in which exposures in one or more jobs routinely
exceed the preceding PEL of 2.0 μg/m3\, and therefore substantial
reductions in exposure would be required to achieve the final PEL; and
(4) application groups in which exposure to beryllium occurs due to
trace levels of beryllium found in dust or fumes that nonetheless can
result in exposures that exceed 0.1 μg/m3\ as an 8-hour TWA under
foreseeable conditions.
The application groups in category 1, where exposures for most jobs
are already at or below the final PEL of 0.2 μg/m3\, typically
handle beryllium alloys containing a low percentage of beryllium (<2
percent) using processes that do not result in significant airborne
exposures. These four application groups are (1) copper rolling,
drawing, and extruding; (2) fabrication of beryllium alloy products;
(3) welding; and (4) aluminum production. The handling of beryllium
alloys in solid form is not expected to result in exposures of concern.
For example, beryllium alloys used in copper rolling, drawing, and
extruding typically contain 2 percent beryllium by weight or less
(Document ID 0081, Attachment 1). One facility noted that the copper-
beryllium alloys it used contained as little as 0.1 percent beryllium
(Document ID 0081, Attachment 1). These processes, such as rolling
operations that consist of passing beryllium alloys through a rolling
press to conform to a desired thickness, tend to produce less
particulate and fume than high energy processes. Exposures can be
controlled using containment, exhaust ventilation, and work practices
that include rigorous housekeeping. In addition, the heating of metal
during welding operations results in the release of fume, but the
beryllium in the welding fume accounts for a relatively small
percentage of the beryllium exposure. Worker exposure to beryllium
during welding activities is largely attributable to flaking oxide
scale on the base metal, which can be reduced through chemically
stripping or pickling the beryllium alloy piece prior to welding on it,
and/or enhancing exhaust ventilation (Corbett, 2006; Kent, 2005;
Materion Information Meeting, 2012).
For application groups in category 2, where baseline exposures for
one or more jobs exceed the final PEL of 0.2 μg/m 3, but
additional controls have been identified that could achieve exposures
at or below the final PEL for most of the operations most of the time,
workers may encounter higher content beryllium (20 percent or more by
weight), or higher temperature processes (Document ID 1662, p. 4.) The
application groups in the second category are: (1) Precision turned
products and (2) secondary smelting, refining, and alloying. While the
median exposures for most jobs in these groups are below the preceding
PEL of 2.0 μg/m3\, the median exposures for some jobs in these
application groups exceed the final PEL of 0.2 μg/m3\ when not
adequately controlled. For these application groups, additional
exposure controls and work practices will be required to reduce
exposures to or below the final PEL for most operations most of the
time. For example, personal samples collected at a precision turned
products facility that machined pure beryllium metal and high beryllium
content materials (40-60 percent) measured exposures on two machinists
of 2.9 and 6.6 μg/m3 (ERG Beryllium Site 4, 2003). A second survey
at this same facility conducted after an upgrade to the ventilation
systems in the mill and lathe departments measured PBZ exposures for
these machinists of 1.1 and 2.3 μg/m3\ (ERG Beryllium Site 9,
2004), and it was noted that not all ventilation was optimally
positioned, indicating that further reduction in exposure could be
achieved. In 2007, the company reported that after the installation of
enclosures on milling machines and additional exhaust, average
exposures to mill and lathe operators were reduced to below 0.2
µg/m3\ (ICBD, 2007). For secondary smelting operations, several
surveys conducted at electronic recycling and precious metal recovery
operations indicate that exposures for mechanical processing operators
can be controlled to or below 0.2 µg/m3\. However, for furnace
operations in secondary smelting, the median value in the exposure
profile exceeds the preceding PEL. Furnace operations involve high
temperatures that produce significant amounts of fumes and particulate
that can be difficult to contain. Therefore, the reduction of 8-hour
average exposures to or below the final PEL may not be achievable for
most furnace operations involved with secondary smelting of beryllium
alloys. In these cases, the supplemental use of respiratory protection
for specific job tasks will be needed to adequately protect furnace
workers for operations where exposures are found to exceed 0.2 μg/
m3\ despite the implementation of all feasible engineering and work
practice controls.
The application groups in category 3 include application groups for
which the exposure profiles indicate that exposures in one or more jobs
routinely exceed the preceding PEL of 2.0 μg/m3\. The three
application groups in this category are: (1) Beryllium production, (2)
beryllium oxide ceramics production, and (3) nonferrous foundries. For
the job groups in which exposures have been found to routinely exceed
the preceding PEL, OSHA identifies additional exposure controls and
work practices that the Agency has determined can reduce exposures to
or below the final PEL, most of the time. For example, OSHA concluded
that exposures to beryllium resulting from material transfer, loading,
and spray drying of beryllium oxide powders can be reduced to or below
0.2 µg/m3 with process enclosures, ventilation hoods, and
diligent housekeeping for material preparation operators working in
beryllium oxide ceramics and composites facilities (FEA, Chapter IV-
04). However, for furnace operations in primary beryllium production
and nonferrous foundries, and shakeout operations at nonferrous
foundries, OSHA recognizes that even after installation of feasible
controls, supplemental use of respiratory protection may be needed to
protect workers adequately (FEA, Chapter IV-03 and IV-05). The evidence
in the rulemaking record is insufficient to conclude that these
operations would be able to reduce the majority of the exposure to
levels below 0.2 μg/m3\ most of the time, and therefore some
increased supplemental use of respiratory protection may be required
for certain tasks in these jobs.
Category 4 includes application groups that encounter exposure to
beryllium due to trace levels found in dust or fumes that nonetheless
can exceed 0.1 μg/m3\ as an 8-hour TWA under foreseeable
conditions. The application groups in this category are (1) coal-fired
power plants in which exposure to beryllium can occur due to trace
levels of beryllium in the fly ash during very dusty maintenance
operations, such as cleaning the air pollution control devices; (2)
aluminum production in which exposure to beryllium can occur due to
naturally occurring trace levels of beryllium found in bauxite ores
used to make aluminum; and (3) abrasive blasting using coal and copper
slag that can contain trace levels of beryllium. Workers who perform
abrasive blasting using either coal or copper slag abrasives are
potentially exposed to beryllium due to the high total exposure to the
blasting media. Due to the very small amounts of beryllium in these
materials, the final PEL for beryllium will be exceeded only during
operations that generate excessive amount of visible airborne dust, for
which engineering controls and respiratory protection are already
required. However, the other workers in the general vicinity do not
experience these high exposures if proper engineering controls and work
practices, such as temporary enclosures and maintaining appropriate
distance during the blasting or maintenance activities, are
implemented.
During the rulemaking process, OSHA requested and received comments
regarding the feasibility of the PEL of 0.2 μg/m3\, as well as the
proposed alternative PEL of 0.1 µg/m3\ (80 FR 47565, 47780 (Aug.
7, 2015)). OSHA did this because it recognizes that significant risk of
beryllium disease is not eliminated at an exposure level of 0.2 μg/
m3\. As discussed below, OSHA finds that the proposed PEL of 0.2
μg/m3\ can be achieved through engineering and work practice
controls in most operations most of the time in all the affected
industry sectors and application groups, and therefore is feasible for
these industries and application groups under the OSH Act. OSHA could
not find, however, that the proposed alternative PEL of 0.1 μg/m3\
is also feasible for all of the affected industry sectors and
application groups.
The majority of commenters, including stakeholders in labor and
industry, public health experts, and the general public, explicitly
supported the proposed PEL of 0.2 µg/m3\ (NIOSH, Document ID
1671, Attachment 1, p. 2; National Safety Council, 1612, p. 3;
Beryllium Health and Safety Committee Task Group, 1655, p. 2; Newport
News Shipbuilding, 1657, p. 1; National Jewish Health (NJH), 1664, p.
2; the Aluminum Association, 1666, p. 1; the Boeing Company, 1667, p.
1; American Industrial Hygiene Association, 1686, p. 2; United
Steelworkers (USW), 1681, p. 7; Andrew Brown, 1636, p. 6; Department of
Defense, 1684, p. 1). In addition, Materion Corporation, the sole
primary beryllium production company in the U.S., and USW, jointly
submitted a draft proposed rule that included an exposure limit of 0.2
μg/m3\ (Document ID 0754, p. 4). In its written comments, Materion
explained that it is feasible to control exposure to levels below 0.2
μg/m3\ through the use of engineering controls and work practices
in most, but not all, operations:
Based on many years' experience in controlling beryllium
exposures, its vigorous product stewardship program in affected
operations, and the judgment of its professional industrial hygiene
staff, Materion Brush believes that the 0.2 μg/m3\ PEL for
beryllium, based on median exposures, can be achieved in most
operations, most of the time. Materion Brush does recognize that it
is not feasible to reduce exposures to below the PEL in some
operations, and in particular, certain beryllium production
operations, solely through the use of engineering and work practice
controls (Document ID 1052).
On the other hand, the Nonferrous Founders' Society (NFFS) asserted
that OSHA had not demonstrated that the final PEL of 0.2 µg/m3\
was feasible for the nonferrous foundry industry (Document ID 1678, pp.
2-3). NFFS asserted that "OSHA has failed to meet its burden of proof
that a ten-fold reduction to the current two micrograms per cubic meter
limit is technologically or economically feasible in the non-ferrous
foundry industry" (Document ID 1678, pp. 2-3; 1756, Tr. 18). In
written testimony submitted as a hearing exhibit, NFFS claimed that
OSHA's supporting documentation in the PEA had no "concrete assurance
on technologic feasibility either by demonstration or technical
documentation" (Document ID 1732, Appendix A, p. 4).
However, contrary to the NFFS comments, which are addressed at
greater length in Section IV-5 of the FEA, OSHA's exposure profile is
based on the best available evidence for nonferrous foundries; the
exposure data are taken from NIOSH surveys, an ERG site visit, and the
California Cast Metals Association (Document ID 1217; 1185; 0341,
Attachment 6; 0899). Materion also submitted substantial amounts of
monitoring data, process descriptions and information of engineering
controls that have been implemented in its facilities to control
beryllium exposure effectively, including operations that involve the
production of beryllium alloys using the same types of furnace and
casting operations as those conducted at nonferrous foundries producing
beryllium alloys (Document ID 0719; 0720; 0723). Furthermore, Materion
submitted the above-referenced letter to the docket stating that, based
on its many years of experience controlling beryllium exposures, a PEL
of 0.2 μg/m3\ can be achieved in most operations, most of the time
(Document ID 1052). Materion's letter is consistent with the monitoring
data Materion submitted, and OSHA considers its statement regarding
feasibility at the final PEL relevant to nonferrous foundries because
Materion has similar operations in its facilities, such as beryllium
alloy production. As stated in Section IV-5 of the FEA, the size and
configuration of nonferrous foundries may vary, but they all use
similar processes; they melt and pour molten metal into the prepared
molds to produce a casting, and remove excess metal and blemishes from
the castings (NIOSH 85-116, 1985). While the design may vary, the basic
operations and worker job tasks are similar regardless of whether the
casting metal contains beryllium.
In the NPRM, OSHA requested that affected industries submit to the
record any available exposure monitoring data and comments regarding
the effectiveness of currently implemented control measures to inform
the Agency's final feasibility determinations. During the informal
public hearings, OSHA asked the NFFS panel to provide information on
current engineering controls or the personal protective equipment used
in foundries claiming to have difficulty complying with the preceding
PEL, but no additional information was provided (Document ID 1756; Tr.
24-25; 1785, p. 1). Thus, the NFFS did not provide any sampling data or
other evidence regarding current exposure levels or existing control
measures to support its assertion that a PEL of 0.2 μg/m3\ is not
feasible, and did not show that the data in the record are insufficient
to demonstrate technological feasibility for nonferrous foundry
industry.
In sum, while OSHA agrees that two of the operations in the
nonferrous foundry industry, furnace and shakeout operations, employing
a relatively small percentage of workers in the industry, may not be
able to achieve the final PEL of 0.2 μg/m3\ most of the time,
evidence in the record indicates that the final PEL is achievable in
the other six job categories in this industry. Therefore, in the FEA,
OSHA finds the PEL of 0.2 μg/m3\ is technologically feasible for
the nonferrous foundry industry.
OSHA also recognizes that engineering and work practice controls
may not be able to consistently reduce and maintain exposures to the
final PEL of 0.2 μg/m3\ in some job categories in other application
groups, due to the processing of materials containing high
concentrations of beryllium, which can result in the generation of
substantial amounts of fumes and particulate. For example, the final
PEL of 0.2 μg/m3\ cannot be achieved most of the time for furnace
operations in primary beryllium production and for some furnace
operation activities in secondary smelting, refining, and alloying
facilities engaged in beryllium recovery and alloying. Workers may need
supplementary respiratory protection during these high exposure
activities where exposures exceed the final PEL of 0.2 μg/m3\ or
STEL of 2.0 μg/m3\ with engineering and work practice controls. In
addition, OSHA has determined that workers who perform open-air
abrasive blasting using mineral grit (i.e., coal slag) will routinely
be exposed to levels above the final PEL (even after the installation
of feasible engineering and work practice controls), and therefore,
these workers will also be required to wear respiratory protection.
Overall, however, based on the information discussed above and the
other evidence in the record and described in Chapter IV of the FEA,
OSHA has determined that for the majority of the job groups evaluated
exposures are either already at or below the final PEL, or can be
adequately controlled to levels below the final PEL through the
implementation of additional engineering and work practice controls for
most operations most of the time. Therefore, OSHA concludes that the
final PEL of 0.2 μg/m3\ is technologically feasible.
In contrast, the record evidence does not show that it is feasible
for most operations in all affected industries and application groups
to achieve the alternative PEL of 0.1 μg/m3\ most of the time. As
discussed below, although a number of operations can achieve this
level, they may be interspersed with operations that cannot, and OSHA
sees value in having a uniform PEL that can be enforced consistently
for all operations, rather than enforcing different PELs for the same
contaminant in different operations.
Several commenters supported a PEL of 0.1 μg/m3\. Specifically,
Public Citizen; the American Federation of Labor and Congress of
Industrial Organizations (AFL-CIO); the International Union, United
Automobile, Aerospace, and Agriculture Implement Workers of America
(UAW); North America's Building Trades Unions (NABTU); and the American
College of Occupational and Environmental Medicine contended that OSHA
should adopt this lower level because of the residual risk at 0.2
μg/m3\
(Document ID 1689, p. 7; 1693, p. 3; 1670, p. 1; 1679, pp. 6-7; 1685,
p. 1; 1756, Tr. 167). Two of these commenters, Public Citizen and the
AFL-CIO, also contended that a TWA PEL of 0.1 μg/m3 is feasible
(Document ID 1756, Tr. 168-169, 197-198). Neither of those commenters,
however, submitted any additional evidence to the record that OSHA
could rely on to conclude that a PEL of 0.1 μg/m3\ is achievable.
On the other hand, the Beryllium Health and Safety Committee and
NJH specifically rejected a PEL of 0.1 μg/m3\ in their comments.
They explained that they believed the proposed PEL of 0.2 μg/m3\
and the ancillary provisions would reduce the prevalence of beryllium
sensitization and chronic beryllium disease (CBD) and be the best
overall combination for protecting workers when taking into
consideration the analytical chemistry capabilities and economic
considerations (Document ID 1655, p. 16; 1664, p. 2).
Based on the record evidence, OSHA cannot conclude that the
alternative PEL of 0.1 μg/m3\ is achievable most of the time for at
least one job category in 8 of the 12 application groups or industries
included in this analysis: Primary beryllium production; beryllium
oxide ceramics and composites; nonferrous foundries; secondary
smelting, refining, and alloying, including handling of scrap and
recycled materials; precision turned products; dental laboratories;
abrasive blasting; and coal-fired electric power generation. In
general, OSHA's review of the available sampling data indicates that
the alternative PEL of 0.1 μg/m3\ cannot be consistently achieved
with engineering and work practice controls in application groups that
use materials containing high percentages of beryllium or that involve
processes that result in the generation of substantial amounts of fumes
and particulate. Variability in processes and materials for operations
involving the heating or machining of beryllium alloys or beryllium
oxide ceramics also makes it difficult to conclude that exposures can
be routinely reduced to below 0.1 μg/m3\. For example, in the
precision turned products industry, OSHA has concluded that exposures
for machinists machining pure beryllium or high beryllium alloys can be
reduced to or below 0.2 μg/m3\, but not 0.1 μg/m3\.
Additionally, OSHA has determined that job categories that involve
high-energy operations will not be able to consistently achieve 0.1
μg/m3\ (e.g., abrasive blasting with coal slag in open-air). These
operations can cause workers to have elevated exposures even when
available engineering and work practice controls are used.
In other cases, paucity of data or other data issues prevent OSHA
from determining whether engineering and work practice controls can
reduce exposures to or below 0.1 μg/m3\ most of the time (see
Chapter IV of the FEA). A large portion of the sample results obtained
by OSHA for the dental laboratories industry and for two of the job
categories in the coal-fired electric power generation industry
(operations workers and routine maintenance workers) were below the
reported limit of detection (LOD). Because the LODs for many of these
samples were higher than 0.1 μg/m3\, OSHA could not assess whether
exposures were below 0.1 μg/m3\. For example, studies of dental
laboratories showed that use of well-controlled ventilation can
consistently reduce exposures to below the LOD of 0.2 μg/m3\.
However, without additional information, OSHA cannot conclude that
exposures can be reduced to or below 0.1 μg/m3\ most of the time.
Therefore, OSHA cannot determine if a PEL of 0.1 μg/m3\ would be
feasible for the dental laboratory industry.
The lack of available data has also prevented OSHA from determining
whether exposures at or below of 0.1 μg/m3\ can be consistently
achieved for machining operators in the beryllium oxide ceramics and
composites industry. As discussed in Section IV-4 of the FEA, the
exposure profile for dry (green) machining and lapping and plate
polishing (two tasks within the machining operator job category) is
based on 240 full-shift PBZ samples obtained over a 10-year period
(1994 to 2003). The median exposure levels in the exposure profile for
green machining and lapping and polishing are 0.16 μg/m3\ and 0.29
μg/m3\, respectively. While the record indicates that improvements
in exposure controls were implemented over time (Frigon, 2005, Document
ID 0825; Frigon, 2004 (Document ID 0826)), data showing to what extent
exposures have been reduced are not available. Nonetheless, because the
median exposures for green machining are already below 0.2 μg/m3\,
and the median exposures for lapping and polishing are only slightly
above the PEL of 0.2 μg/m3\, OSHA concluded that the controls that
have been implemented are sufficient to reduce exposures to at or below
0.2 μg/m3\ most of the time. However, without additional
information, OSHA cannot conclude that exposures could be reduced to or
below 0.1 μg/m3\ most of the time for these tasks.
Most importantly for this analysis, the available evidence
demonstrates that the alternative PEL of 0.1 μg/m3\ is not
achievable in five out of the eight job categories in the nonferrous
foundries industry: Furnace operator, shakeout operator, pouring
operator, material handler, and molder. As noted above, the first two
of these job categories, furnace operator and shakeout operator, which
together employ only a small fraction of the workers in this industry,
cannot achieve the final PEL of 0.2 μg/m3\ either, but evidence in
the record demonstrates that nonferrous foundries can reduce the
exposures of most of the rest of the workers in the other six job
categories to or below the final PEL of 0.2 μg/m3\, most of the
time. However, OSHA's feasibility determination for the pouring
operator, material handler, and molder job categories, which together
employ more than half the workers at these foundries, does not allow
the Agency to conclude that exposures for those jobs can be
consistently lowered to the alternative PEL of 0.1 μg/m3\. See
Section IV-5 of the FEA. Thus, OSHA cannot conclude that most
operations in the nonferrous foundries industry can achieve a PEL of
0.1 μg/m3\, most of the time. Accordingly, OSHA finds that the
alternative PEL of 0.1 μg/m3\ is not feasible for the nonferrous
foundries industry.
OSHA has also determined either that information in the rulemaking
record demonstrates that 0.1 μg/m3\ is not consistently achievable
in a number of operations in other affected industries or that the
information is insufficient to establish that engineering and work
practice controls can consistently reduce exposures to or below 0.1
μg/m3\. Therefore, OSHA finds that the proposed alternative PEL of
0.1 μg/m3\ is not appropriate, and the rule's final PEL of 0.2
μg/m3\ is the lowest exposure limit that can be found to be
technologically feasible through engineering and work practice controls
in all of the affected industries and application groups included in
this analysis.
Because of this inability to achieve 0.1 μg/m3\ in many
operations, if OSHA were to adopt a PEL of 0.1 μg/m3\, a
substantial number of employees would be required to wear respirators.
As discussed in the Summary and Explanation for paragraph (f), Methods
of Compliance, use of respirators in the workplace presents a number of
independent safety and health concerns. Workers wearing respirators may
experience diminished vision, and respirators can impair the ability of
employees to communicate with one another. Respirators can impose
physiological burdens on employees due to the weight of the respirator
and increased breathing resistance
experienced during operation. The level of physical work effort
required, the use of protective clothing, and environmental factors
such as temperature extremes and high humidity can interact with
respirator use to increase the physiological strain on employees.
Inability to cope with this strain as a result of medical conditions
such as cardiovascular and respiratory diseases, reduced pulmonary
function, neurological or musculoskeletal disorders, impaired sensory
function, or psychological conditions can place employees at increased
risk of illness, injury, and even death. The widespread, routine use of
respirators for extended periods of time that may be required by a PEL
of 0.1 μg/m3\ creates more significant concerns than the less
frequent respirator usage that is required by a PEL of 0.2 μg/m3\.
Furthermore, OSHA concludes that it would complicate both
compliance and enforcement of the rule if it were to set a PEL of 0.1
μg/m3\ for some industries or operations and a PEL of 0.2 μg/
m3\ for the remaining industries and operations where technological
feasibility at the lower PEL is either unattainable or unknown. OSHA
may exercise discretion to issue a uniform PEL if it determines that
the PEL is technologically feasible for all affected industries (if not
for all affected operations) and that a uniform PEL would constitute
better public policy. See Pertinent Legal Authority (discussing the
Chromium decision). In declining to lower the PEL to 0.1 μg/m3\ for
any segment of the affected industries, OSHA has made that
determination here. Therefore, OSHA has determined that the proposed
alternative PEL of 0.1 μg/m3\ is not appropriate.
OSHA also evaluated the technological feasibility of the final STEL
of 2.0 μg/m3\ and the alternative STEL of 1.0 μg/m3\. An
analysis of the available short-term exposure measurements presented in
Chapter IV, Section 15 of the FEA indicates that elevated exposures can
occur during short-term tasks such as those associated with the
operation and maintenance of furnaces at primary beryllium production
facilities, at nonferrous foundries, and at secondary smelting
operations. Peak exposures can also occur during the transfer and
handling of beryllium oxide powders. OSHA finds that in many cases, the
control of peak short-term exposures associated with these intermittent
tasks will be necessary to reduce workers' TWA exposures to or below
the final PEL. The short-term exposure data presented in the FEA show
that the majority (79%) of these exposures are already below 2.0 μg/
m3\.
A number of stakeholders submitted comments related to the proposed
and alternative STELs. Some of these stakeholders supported a STEL of
2.0 μg/m3\. Materion stated that a STEL of 2.0 μg/m3\ for
controlling the upper range of worker short term exposures is
sufficient to prevent CBD (Document ID 1661, p. 3). Other commenters
recommended a STEL of 1.0 μg/m3\ (Document ID 1661, p. 19; 1681, p.
7). However, no additional engineering controls capable of reducing
short term exposures to at or below 1.0 μg/m3\ were identified by
these commenters. OSHA provides a full discussion of the public
comments in the Summary and Explanation section of this preamble. OSHA
has determined that the implementation of engineering and work practice
controls required to maintain full shift exposures at or below a PEL of
0.2 μg/m3\ will reduce short term exposures to 2.0 μg/m3\ or
below, and that a STEL of 1.0 μg/m3\ would require additional
respirator use. Furthermore, OSHA notes that the combination of a PEL
of 0.2 μg/m3\ and a STEL of 2.0 μg/m3\ would, in most cases,
keep workers from being exposed to 15 minute intervals of 1.0 μg/
m3\. See Table IV.78 of Chapter IV of the FEA.
Therefore, OSHA concludes that the STEL of 2.0 μg/m3\ can be
achieved for most operations most of the time, given that most short-
term exposures are already below 2.0 μg/m3\. OSHA recognizes that
for a small number of tasks, short-term exposures may exceed the final
STEL, even after feasible control measures to reduce TWA exposure to or
below the final PEL have been implemented, and therefore, some limited
use of respiratory protection will continue to be required for short-
term tasks in which peak exposures cannot be reduced to less than 2.0
μg/m3\ through use of engineering controls.
After careful consideration of the record, including all available
data and stakeholder comments in the record, OSHA has determined that a
STEL of 2.0 μg/m3\ is technologically feasible. Thus, as explained
in the Summary and Explanation for paragraph (c), OSHA has retained the
proposed value of 2.0 μg/m3\ as the final STEL.
E. Costs of Compliance
In Chapter V, Costs of Compliance, OSHA assesses the costs to
general industry, maritime, and construction establishments in all
affected application groups of reducing worker exposures to beryllium
to an eight-hour time-weighted average (TWA) permissible exposure limit
(PEL) of 0.2 μg/m3\ and to the final short-term exposure limit
(STEL) of 2.0 μg/m3\, as well as of complying with the final
standard's ancillary provisions. These ancillary provisions encompass
the following requirements: Exposure monitoring, regulated areas (and
competent person in construction), a written exposure control plan,
protective work clothing, hygiene areas and practices, housekeeping,
medical surveillance, medical removal, familiarization, and worker
training. This final cost assessment is based in part on OSHA's
technological feasibility analysis presented in Chapter IV of the FEA;
analyses of the costs of the final standard conducted by OSHA's
contractor, Eastern Research Group (ERG); and the comments submitted to
the docket in response to the request for information (RFI) as part of
the Small Business Regulatory Enforcement Fairness Act (SBREFA)
process, comments submitted to the docket in response to the PEA,
comments during the hearings conducted in March 2016, and comments
submitted to the docket after the hearings concluded.
Table VIII-4 presents summary of the annualized costs. All costs in
this chapter are expressed in 2015 dollars and were annualized using a
discount rate of 3 percent. (Costs at other discount rates are
presented in the chapter itself). Annualization periods for
expenditures on equipment are based on equipment life, and one-time
costs are annualized over a 10-year period. Chapter V provides detailed
explanation of the basis for these cost estimates.
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F. Economic Feasibility and Regulatory Flexibility Determination
In Chapter VI, OSHA investigates the economic impacts of its final
beryllium rule on affected employers. This impact investigation has two
overriding objectives: (1) To establish whether the final rule is
economically feasible for all affected application groups/
industries,\31\ and (2) to determine if the Agency can certify that the
final rule will not have a significant economic impact on a substantial
number of small entities.
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\31\ As noted in the FEA, OSHA uses the umbrella term
"application group" to refer either to an industrial sector or to
a cross-industry group with a common process. In the industrial
profile chapter, because some of the discussion being presented has
historically been framed in the context of the economic feasibility
for an "industry," the Agency uses the term "application group"
and "industry" interchangeably.
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Table VIII-5 presents OSHA's screening analysis, which shows costs
as percentage of revenues and as a percentage of profits. The chapter
explains why these screening analysis
results can reasonably be viewed as economically feasible. Section
VIII.j shows similar results for small and very small entities.
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In Chapter VII, OSHA estimates the benefits and net benefits of the
final beryllium rule. The methodology for these estimates largely
remains the same as in the PEA. OSHA did not receive many comments
challenging any aspect
of the benefits analysis presented in the PEA. There are, however, a
few significant alterations, such as: Using an empirical turnover rate
as part of the estimation of exposure response functions, full analysis
of the population model with varying turnover (a model only briefly
presented in the PEA), and presentation of a statistical proportional
hazard model in response to comment. The other large change to the
benefits analysis is the result of the increase in the scope of the
rule to protect workers in the construction and ship-building
industries. In the proposed rule, coverage of these latter industries
was only presented as an alternative and therefore were not included in
the benefits in the PEA, but they are covered by the final rule.
This chapter proceeds in five steps. The first step estimates the
numbers of diseases and deaths prevented by comparing the current
(baseline) situation to a world in which the final PEL is adopted in a
final standard, and in which employees are exposed throughout their
working lives to either the baseline or the final PEL. The second step
also assumes that the final PEL is adopted, but uses the results from
the first step to estimate what would happen under a realistic scenario
in which new employees will not be exposed above the final PEL, while
employees already at work will experience a combination of exposures
below the final PEL and baseline exposures that exceed the final PEL
over their working lifetime. The comparison of these steps is given in
Table VIII-6. OSHA also presents in Chapter VII similar kinds of
results for a variety of other risk assessment and population models.
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The third step covers the monetization of benefits. Table VIII-7
presents the monetization of benefits at various interest rates and
monetization values.
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In the fourth step, OSHA estimates the net benefits of the final
rule by comparing the monetized benefits to the costs presented in
Chapter V of the FEA. These values are presented in Table VIII-8. The
table shows that benefits exceed costs for all situations except for
the low estimate of benefits using a 7 percent discount rate. The low
estimate of benefits reflects the assumption that the ancillary
provisions have no independent effect in reducing cases of CBD. OSHA
considers this assumption to be very unlikely, based on the available
evidence.
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In the fifth step, OSHA provides a sensitivity analysis to explore
the robustness of the estimates of net benefits with respect to many of
the assumptions made in developing and applying the underlying models.
This is done because the models underlying each step inevitably need to
make a variety of assumptions based on limited data. OSHA invited
comments on each aspect of the data and methods used in this chapter,
and received none specifically on the sensitivity analysis. Because
dental laboratories constituted a significant source of both costs and
benefits to the proposal, the PEA indicated that OSHA was particularly
interested in comments regarding the appropriateness of the model,
assumptions, and data for estimating the benefits to workers in that
industry. Although the Agency did not receive any comments on this
question directly, the American Dental Association's comments relevant
to the underlying use of beryllium alloys in dental labs are addressed
in Chapter III of the FEA. The Agency has not altered its main
estimates of the exposure profile for dental laboratory workers, but
provides sensitivity analyses in the FEA to examine the outcome if a
lower percentage of dental laboratories were to substitute materials
that do not contain beryllium for beryllium-containing materials. OSHA
also estimates net benefits with a variety of scenarios in which dental
laboratories are not included. All of these results are presented in
Chapter VII of the FEA.
H. Regulatory Alternatives
Chapter VIII presents the costs, benefits and net benefits of a
variety of regulatory alternatives.
I. Final Regulatory Flexibility Analysis
The Regulatory Flexibility Act, (RFA), Public Law 96-354, 94 Stat.
1164 (codified at 5 U.S.C. 601), requires Federal agencies to consider
the economic impact that a final rulemaking will have on small
entities. The RFA states that whenever an agency promulgates a final
rule that is required to conform to the notice-and-comment rulemaking
requirements of section 553 of the Administrative Procedure Act (APA),
the agency shall prepare a final regulatory flexibility analysis
(FRFA). 5 U.S.C. 604(a).
However, 5 U.S.C. 605(b) of the RFA states that Section 604 shall
not apply to any final rule if the head of the agency certifies that
the rule will not, if promulgated, have a significant economic impact
on a substantial number of small entities. As discussed in Chapter VI
of the FEA, OSHA was unable to so certify for the final beryllium rule.
For OSHA rulemakings, as required by 5 U.S.C. 604(a), the FRFA must
contain:
1. A statement of the need for, and objectives of, the rule;
2. a statement of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
statement of the assessment of the agency of such issues, and a
statement of any changes made in the proposed rule as a result of such
comments;
3. the response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration (SBA) in
response to the proposed rule, and a detailed statement of any change
made to the proposed rule in the final rule as a result of the
comments;
4. a description of and an estimate of the number of small entities
to which the rule will apply or an explanation of why no such estimate
is available;
5. a description of the projected reporting, recordkeeping and
other
compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record;
6. a description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected; and for a covered agency, as
defined in section 609(d)(2), a description of the steps the agency has
taken to minimize any additional cost of credit for small entities.
The Regulatory Flexibility Act further states that the required
elements of the FRFA may be performed in conjunction with or as part of
any other agenda or analysis required by any other law if such other
analysis satisfies the provisions of the FRFA. 5 U.S.C. 605(a).
In addition to these elements, OSHA also includes in this section
the recommendations from the Small Business Advocacy Review (SBAR)
Panel and OSHA's responses to those recommendations.
While a full understanding of OSHA's analysis and conclusions with
respect to costs and economic impacts on small entities requires a
reading of the complete FEA and its supporting materials, this FRFA
will summarize the key aspects of OSHA's analysis as they affect small
entities.
The Need for, and Objective of, the Rule
The objective of the final beryllium standard is to reduce the
number of fatalities and illnesses occurring among employees exposed to
beryllium. This objective will be achieved by requiring employers to
install engineering controls where appropriate and to provide employees
with the equipment, respirators, training, medical surveillance, and
other protective measures necessary to perform their jobs safely. The
legal basis for the rule is the responsibility given the U.S.
Department of Labor through the Occupational Safety and Health Act of
1970 (OSH Act). The OSH Act provides that, in promulgating health
standards dealing with toxic materials or harmful physical agents, the
Secretary "shall set the standard which most adequately assures, to
the extent feasible, on the basis of the best available evidence, that
no employee will suffer material impairment of health or functional
capacity even if such employee has regular exposure to the hazard dealt
with by such standard for the period of his working life." 29 U.S.C.
655(b)(5). See Section II of the preamble for a more detailed
discussion.
Chronic beryllium disease (CBD) is a hypersensitivity, or allergic
reaction, to beryllium that leads to a chronic inflammatory disease of
the lungs. It takes months to years after final beryllium exposure
before signs and symptoms of CBD occur. Removing an employee with CBD
from the beryllium source does not always lead to recovery. In some
cases CBD continues to progress following removal from beryllium
exposure. CBD is not a chemical pneumonitis but an immune-mediated
granulomatous lung disease. OSHA's final risk assessment, presented in
Section VI of the preamble, indicates that there is significant risk of
beryllium sensitization and chronic beryllium disease from a 45-year
(working life) exposure to beryllium at the current TWA PEL of 2 μg/
m3\. The risk assessment further indicates that there is significant
risk of lung cancer to workers exposed to beryllium at the current TWA
PEL of 2 μg/m3\. The final standard, with a lower PEL of 0.2 μg/
m3\, will help to address these health concerns. See the Health
Effects and Risk Assessment sections of the preamble for further
discussion.
Summary of Significant Issues Raised by Comments on the
Initial Regulatory Flexibility Analysis (IRFA) and OSHA's Assessment
of, and Response to, Those Issues
This section of the FRFA focuses only on public comments concerning
significant issues raised on the Initial Regulatory Flexibility
Analysis (IRFA). OSHA received only one such comment.
The Non-Ferrous Founders' Society claimed that the costs of the
rule will disproportionately affect small employers and result in job
losses to foreign competition (Document ID 1678, p. 3). This comment is
addressed in the FEA in the section on International Trade Effects in
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility
Determination. The summary of OSHA's response is that, in general,
metalcasters in the U.S. have shortened lead times, improved
productivity through computer design and logistics management, expanded
design and development services to customers, and provided a higher
quality product than foundries in China and other nations where labor
costs are low (Document ID 1780, p. 3-12). All of these measures,
particularly the higher quality of many U.S. metalcasting products and
the ability of domestic foundries to fulfill orders quickly, are
substantial advantages for U.S. metalcasters that may outweigh the very
modest price increases that might occur due to the final rule. For a
more detailed response please see the section on International Trade
Effects in Chapter VI of the FEA.
Response to Comments by the Chief Counsel for Advocacy of the Small
Business Administration and OSHA'S Response to Those Comments
The Chief Counsel for Advocacy of the Small Business Administration
("Advocacy") did not provide OSHA with comments on this rule.
A Description of, and an Estimate of, the Number of Small
Entities To Which the Rule Will Apply
OSHA has analyzed the impacts associated with this final rule,
including the type and number of small entities to which the standard
will apply. In order to determine the number of small entities
potentially affected by this rulemaking, OSHA used the definitions of
small entities developed by the Small Business Administration (SBA) for
each industry.
OSHA estimates that approximately 6.600 small business entities
would be affected by the beryllium standard. Within these small
entities, 33,800 workers are exposed to beryllium and would be
protected by this final standard. A breakdown, by industry, of the
number of affected small entities is provided in Table III-14 in
Chapter III of the FEA.
OSHA estimates that approximately 5,280 very small entities--those
with fewer than 20 employees--would be affected by the beryllium
standard. Within these very small entities, 11,800 workers are exposed
to beryllium and would be protected by the standard. A breakdown, by
industry, of the number of affected very small entities is provided in
Table III-15 in Chapter III of the FEA.
A Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Rule
Tables VIII-9 and VIII-10 show the average costs of the beryllium
standard and the costs of compliance as a percentage of profits and
revenues by NAICS code for, respectively, small entities (classified as
small by SBA) and very small entities (those with fewer than 20
employees). The full derivation of these costs is presented in Chapter
V. The cost for SBA-defined small entities ranges from a low of $832
per entity for
entities in NAICS 339116a: Dental Laboratories, to a high of about
$599,836 for NAICS 331313: Alumina Refining and Primary Aluminum
Production.
The annualized cost for very small entities ranges from a low of
$542 for entities in NAICS 339116a: Dental Laboratories, to a high of
about $34,222 for entities in NAICS 331529b: Other Nonferrous Metal
Foundries (except Die-Casting).\32\
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\32\ The cost of $542 for NAICS 339116a is the sum of a $524
cost to substitute for a non-hazard material and $19 for cost of
ancillary provisions. The total cost of $34,222 for NAICS 331529b is
the sum of $22,601 for engineering controls, $186 for respirator
costs, and $11,435 for ancillary provisions.
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Description of the Steps OSHA Has Taken To Minimize the Significant
Economic Impact on Small Entities Consistent With the Stated Objectives
of Applicable Statutes and Statement of the Reasons For Selecting the
Alternative Adopted in the Final Rule
OSHA has made a number of changes in the final beryllium rule that
will serve to minimize significant impacts on small entities consistent
with the objectives of the OSH Act. These changes are explained in more
detail in Section XVI: Summary and Explanation in this preamble.
During the SBAR Panel, SERs requested a clearer definition of the
triggers for medical surveillance. This concern was rooted in the cost
of BeLPTs and the trigger of potential skin contact. For the final
rule, the Agency has removed skin contact as a trigger for medical
surveillance. OSHA has also reduced the frequency of medical
surveillance from annually (in the proposed rule) to biennially in the
final rule.
In the final rule, OSHA has added a performance option, as an
alternative to scheduled monitoring, to allow employers to comply with
exposure assessment requirements. This performance option should allow
employers more flexibility, and often lower cost, in complying with the
exposure assessment requirements.
Some SERs were already applying many of the protective controls and
practices that would be required by the ancillary provisions of the
standard. However, many SERs objected to the requirements regarding
hygiene facilities. For this final rule, OSHA has concluded that all
affected employers currently have hand washing facilities. OSHA has
also concluded that no affected employers will be required to install
showers. OSHA noted in the PEA that some facilities already have
showers. There were no comments challenging the Agency's preliminary
determinations regarding the existing availability of shower facilities
or the means of preventing contamination, so the Agency concludes that
all employers have showers where needed. Therefore, employers will not
need to provide any new shower facilities to comply with the
standard.\33\
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\33\ OSHA reached the same conclusion in the PEA (p. V-118). For
information purposes, OSHA estimated the initial cost of installing
portable showers at $39,687, with an annualized cost of $4,653 per
facility (Id.) and did not receive any comments suggesting that
shower costs should be included or regarding the cost of installing
them. The annual cost per employee for shower supplies, towels, and
time required for showering was estimated to be $1,519. However, as
indicated above in the text, the Agency believed that employers
would be able to comply with the standard by less costly means than
the installation of shower facilities.
---------------------------------------------------------------------------
Similarly, in the PEA the Agency included no additional costs for
readily accessible washing facilities, under the expectation that
employers already have such facilities in place (PEA p. IX-19).
Although the abrasive blasters exposed to beryllium in maritime and
construction work may not have been expressly addressed in the PEA,
OSHA notes that their employers are typically already required to
provide readily accessible washing facilities to comply with other OSHA
standards such as its sanitation standard at 29 CFR 1926.51(f)(1).\34\
In the absence of additional comment, OSHA is not including any costs
for washing facilities in the FEA.
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\34\ OSHA's shipyard standard at 29 CFR 1915.58(e) requires
handwashing facilities "at or adjacent to each toilet facility"
and "equipped with . . . running water and soap, or with waterless
skin-cleansing agents that are capable of . . . neutralizing the
contaminants to which the employee may be exposed." OSHA's
construction standard at 29 CFR 1926.51(f)(1) requires "adequate
washing facilities for employees engaged in . . . operations where
contaminants may be harmful to the employees. Such facilities shall
be in near proximity to the worksite and shall be so equipped as to
enable employees to remove such substances."
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OSHA's shipyard standard at 29 CFR 1915.58(e) requires handwashing
facilities "at or adjacent to each toilet facility" and "equipped
with . . . running water and soap, or with waterless skin-cleansing
agents that are capable of . . . neutralizing the contaminants to which
the employee may be exposed." OSHA's construction standard at 29 CFR
1926.51(f)(1) requires "adequate washing facilities for employees
engaged in . . . operations where contaminants may be harmful to the
employees. Such facilities shall be in near proximity to the worksite
and shall be so equipped as to enable employees to remove such
substances."
The Agency has determined that the long-term rental of modular
units was representative of costs for a range of reasonable approaches
to comply with the change room part of the provision. Alternatively,
employers could renovate and rearrange their work areas in order to
meet the requirements of this provision.
Finally, in the final rule, OSHA has extended the compliance
deadlines for change rooms from one year to two years and for
engineering controls from two years to three years.
Regulatory Alternatives
For the convenience of those persons interested only in OSHA's
regulatory flexibility analysis, this section repeats the discussion
presented in Chapter VIII of the FEA, but only for the regulatory
alternatives to the final OSHA beryllium standard that would have
lowered costs.
Each regulatory alternative presented here is described and
analyzed relative to the final rule. Where appropriate, the Agency
notes whether the regulatory alternative, to have been a legitimate
candidate for OSHA consideration, required evidence contrary to the
Agency's final findings of significant risk and feasibility. For this
chapter on the Final Regulatory Flexibility Analysis, the Agency is
only presenting regulatory alternatives that would have reduced costs
for small entities. (See Chapter VIII for the full list of all
alternatives analyzed.) There are 14 alternatives that would have
reduced costs for small entities (and for all businesses in total).
Using the numbering scheme from Chapter VIII of the FEA, these are
Regulatory Alternatives #1a, #2a, #2b, #5, #6, #7, #8, #9, #10, #11,
#12, #13, #15, #16, #18, and #22. OSHA has organized these 16 cost-
reducing alternatives (and a general discussion of considered phase-ins
of the rule) into four categories: (1) Scope; (2) exposure limits; (3)
methods of compliance; and (4) ancillary provisions.
(1) Scope Alternatives
The scope of the beryllium final rule applies to general industry
work, construction and maritime activities. In addition, the final rule
provides an exemption for those working with materials containing only
trace amounts of beryllium (less than 0.1% by weight) when the employer
has objective data that employee exposure to beryllium will remain
below the action level as an 8-hour TWA under any foreseeable
conditions.
The first set of regulatory alternatives would alter the scope of
the final standard by differing in coverage of groups of employees and
employers. Regulatory Alternatives #1a, #2a, and #2b would decrease the
scope of the final standard.
Regulatory Alternative #1a would exclude all operations where
beryllium exists only as a trace contaminant; that is, where the
materials used contain less than 0.1% beryllium by weight, with no
other conditions. OSHA has identified two industries with workers
engaged in general industry work that would be excluded under
Regulatory Alternative #1a: Primary aluminum production and coal-fired
power generation.
Table VIII-11 presents, for informational purposes, the estimated
costs, benefits, and net benefits of Regulatory Alternative #1a using
alternative discount rates of 3 percent and 7 percent. In addition,
this table presents the incremental costs, incremental benefits, and
incremental net benefits of this alternative relative to the final
rule. Table VIII-11 also breaks out costs by provision, and benefits by
type of disease and by morbidity/mortality prevented. (Note:
"morbidity" cases are cases where health effects are limited to non-
fatal illness; in these cases there is no further disease progression
to fatality).
As shown in Table VIII-11, Regulatory Alternative #1a would
decrease the annualized cost of the rule from $73.9 million to $64.6
million using a 3 percent discount rate and from $76.6 million to $67.0
million using a 7 percent discount rate. Annualized benefits in
monetized terms would decrease from $560.9 million to $515.7 million,
using a 3 percent discount rate, and from $249.1 million to $229.0
million using a 7 percent discount rate. Net benefits would decrease
from $487.0 million to $451.1 million using a 3 percent discount rate
and from $172.4 million to $162.0 million using a 7 percent discount
rate.
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Regulatory Alternative #2a would exclude construction and maritime
work from the scope of the final standard. For example, this
alternative would exclude abrasive blasters, pot tenders, and cleanup
staff working in
construction and shipyards who have the potential for airborne
beryllium exposure during blasting operations and during cleanup of
spent media.
Table VIII-12 presents the estimated costs, benefits, and net
benefits of Regulatory Alternative #2a using alternative discount rates
of 3 percent and 7 percent. In addition, this table presents the
incremental costs, incremental benefits, and incremental net benefits
of these alternatives relative to the final rule. Table VIII-12 also
breaks out costs by provision and benefits by type of disease and by
morbidity/mortality.
As shown in Table VIII-12, Regulatory Alternative #2a would
decrease costs from $73.9 million to $62.0 million, using a 3 percent
discount rate, and from $76.6 million to $64.4 million using a 7
percent discount rate. Annualized benefits would decrease from $560.9
million to $533.3 million, using a 3 percent discount rate, and from
$249.1 million to $236.8 million using a 7 percent discount rate. Net
benefits would change from $487.0 million to $471.3 million, using a 3
percent discount rate, and is essentially unchanged at a discount rate
of 7 percent, with the final rule having net benefits of $172.4 million
while the alternative has $172.5 million. Thus, at a 7 percent discount
rate, the costs exceed the benefits for this alternative by $0.1
million per year. However, OSHA believes that for these industries, the
cost estimate is severely overestimated because 45 percent of the costs
are for exposure monitoring assuming that employers use the periodic
monitoring option. Employers in this sector are far more likely to use
the performance based monitoring options at considerably reduced costs.
If this is the case, benefits would exceed costs even at a 7 percent
discount rate.
Regulatory Alternative #2b would eliminate the ancillary provisions
in the final rule for the shipyard and construction sectors and for any
operations where beryllium exists only as a trace contaminant.
Accordingly, only the final TWA PEL and STEL would apply to employers
in these sectors and operations (through 29 CFR 1910.1000 Tables Z-1
and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A). Operations in
general industry where the ancillary provisions would be eliminated
under Regulatory Alternative #2b include aluminum smelting and
production and coal-powered utility facilities and any other operations
where beryllium is present only as a trace contaminant (in addition to
all operations in construction and shipyards).
As shown in Table VIII-13, Regulatory Alternative #2b would
decrease the annualized cost of the rule from $73.9 million to $53.5
million using a 3 percent discount rate, and from $76.6 to $55.6
million using a 7 percent discount rate. Annualized benefits would
decrease from $560.9 million to $493.3 million, using a 3 percent
discount rate, and from $249.1 million to $219.1 million, using a 7
percent discount rate. Net benefits would decrease from $487.0 million
to $439.8 million, using a 3 percent discount rate, and from $172.4
million to $163.5 million, using a 7 percent discount rate.
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(2) Exposure Limit (TWA PEL, STEL, and Action Level) Alternatives
Paragraph (c) of the three final standards establishes two PELs for
beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of
0.2 μg/m3\ (paragraph (c)(1)), and a 15-minute short-term exposure
limit (STEL) of 2.0 μg/m3\ (paragraph (c)(2)). OSHA has defined the
action level for the final standard as an airborne concentration of
beryllium of 0.1 μg/m3\ calculated as an eight-hour TWA (paragraph
(b)). In this final rule, as in other standards, the action level has
been set at one half of the TWA PEL.
Regulatory Alternative #5 would set a higher TWA PEL at 0.5
µg/m3\ and an action level at 0.25 µg/m3\. This
alternative responds to an issue raised during the Small Business
Advocacy Review (SBAR) process conducted in 2007 to consider a draft
OSHA beryllium proposed rule that culminated in an SBAR Panel report
(SBAR, 2008). That report included a recommendation that OSHA consider
both the economic impact of a low TWA PEL and regulatory alternatives
that would ease cost burden for small entities. OSHA has provided a
full analysis of the economic impact of its final PELs (see Chapter VI
of the FEA), and Regulatory Alternative #5 was considered in response
to the second half of that recommendation. However, the higher 0.5
µg/m3\ TWA PEL is not consistent with the Agency's mandate under
the OSH Act to promulgate a lower PEL if it is feasible and could
prevent additional fatalities and non-fatal illnesses. The data
presented in Table VIII-14 below indicate that the final TWA PEL would
prevent additional fatalities and non-fatal illnesses relative to
Regulatory Alternative #5.
Table VIII-14 below presents, for informational purposes, the
estimated costs, benefits, and net benefits of the final rule under the
final TWA PEL of 0.2 μg/m3\ and for the regulatory alternative TWA
PEL of 0.5 μg/m3\ (Regulatory Alternative #5), using alternative
discount rates of 3 percent and 7 percent. In addition, the table
presents the incremental costs, the incremental benefits, and the
incremental net benefits of going from a TWA PEL of 0.5 μg/m3\ to
the final TWA PEL of 0.2 μg/m3\. Table VIII-14 also breaks out
costs by provision and benefits by type of disease and by morbidity/
mortality.
As Table VIII-14 shows, going from a TWA PEL of 0.5 μg/m3\ to a
TWA PEL of 0.2 μg/m3\ would prevent, annually, an additional 30
beryllium-related fatalities and an additional 16 non-fatal illnesses.
This is consistent with OSHA's final risk assessment, which indicates
significant risk to workers exposed at a TWA PEL of 0.5 μg/m3\;
furthermore, OSHA's final feasibility analysis indicates that a lower
TWA PEL than 0.5 μg/m3\ is feasible. Net benefits of this
regulatory alternative versus the final TWA PEL of 0.2 μg/m3\ would
decrease from $487.0 million to $376.5 million using a 3 percent
discount rate and from $172.4 million to $167.2 million using 7 percent
discount rate.
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Regulatory Alternative With Unchanged PEL But Full Ancillary Provisions
An Informational Analysis: This final regulation has the somewhat
unusual feature for an OSHA substance-specific health standard that
most of the quantified benefits that OSHA estimated would come from the
ancillary provisions rather than from meeting the PEL solely with
engineering controls (see Chapter VII of the FEA for a more detailed
discussion). OSHA decided to analyze for informational purposes the
effect of retaining the preceding PEL but applying all of the ancillary
provisions, including respiratory protection. Under this approach, the
TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the
other final provisions (including respiratory protection) would be
required with their triggers remaining the same as in the final rule--
either the presence of airborne beryllium at any level (e.g., initial
monitoring, written exposure control plan), at certain kinds of dermal
exposure (PPE), at the action level of 0.1 µg/m3\ (e.g.,
periodic monitoring, medical removal), or at 0.2 µg/m3\ (e.g.,
regulated areas, respiratory protection, medical surveillance).
Given the record regarding beryllium exposures, this approach is
not one OSHA could legally adopt. The absence of engineering controls
would not be consistent with OSHA's application of the hierarchy of
controls, in which engineering controls are applied to eliminate or
control hazards, before administrative controls and personal protective
equipment are applied to address remaining exposures. Section 6(b)(5)
of the OSH Act requires OSHA to "set the standard which most
adequately assures, to the extent feasible, on the basis of the best
available evidence, that no employee will suffer material impairment of
health or functional capacity even if such employee has regular
exposure to the hazard dealt with by such standard for the period of
his working life." For that reason, this additional analysis is
provided strictly for informational purposes. E.O. 12866 and E.O. 13563
direct agencies to identify approaches that maximize net benefits, and
this analysis is purely for the purpose of exploring whether this
approach would hold any real promise to maximize net benefits if it was
permissible under the OSH Act. It does not appear to hold such promise
because an ancillary-provisions-only approach would not be as
protective and thus offers fewer benefits than one that includes a
lower PEL and engineering controls. Also, OSHA estimates the costs
would be about the same (or slightly lower, depending on certain
assumptions) under that approach as under the traditional final
approach.
When examined on an industry-by-industry basis, OSHA found that
some industries would have lower costs if they could adopt the
ancillary-provision-only approach. Some employers would use engineering
controls where they are cheaper, even if they are not mandatory. OSHA
does not have sufficient information to do an analysis employer-by-
employer of when the ancillary-provisions-only approach might be
cheaper. In the majority of affected industries, the Agency estimates
there are no cost savings to the ancillary-provisions-only approach.
However, OSHA estimates an annualized total cost saving of $2.7 million
per year for entire industries where the ancillary-provisions-only
approach would be less expensive.
The above discussion does not account for the possibility that the
lack of engineering controls would result in higher beryllium exposures
for workers in adjacent (non-production) work areas due to the
increased level of beryllium in the air. Because of a lack of data, and
because the issue did not arise in the other regulatory alternatives
OSHA considered (all of which have a PEL of less than 2.0 µg/
m3\), OSHA did not examine exposure levels in non-production areas for
either cost or benefit purposes. To the extent such exposure levels
would be above the action level, there would be additional costs for
respiratory protection and medical surveillance.
If respirators were as effective as engineering controls, the
ancillary-provisions-only approach would have benefits comparable to
the benefits of the final rule. However, in this alternative most
exposed individuals would be required to use respirators, which OSHA
considers less effective than engineering controls in preventing
employee exposure to beryllium. OSHA also examined what the benefits
would be if respirators were not required, were not worn, or were
ineffective. OSHA found that, if all of the other aspects of the
benefits analysis remained the same, the annualized benefits would be
reduced by from $33.2 million using a discount rate of 3 percent, and
$22.4 using a discount rate of 7 percent, largely as a result of
failing to reduce deaths from lung cancer, which are unaffected by the
ancillary provisions. However, there are also other reasons to believe
that benefits may be even lower:
(1) As noted above, in the final rule OSHA did not consider
benefits caused by reductions in exposure in non-production areas.
Unless employers act to reduce exposures in the production areas, the
absence of a requirement for such controls would largely negate such
benefits from reductions in exposure in the non-productions areas.
(2) OSHA judges that the benefits of the ancillary provisions (a
midpoint estimate of eliminating 45 percent of all remaining cases of
CBD for all sectors except for abrasive blasting and coal-fired power
plants, and an estimate of 11.25 percent, or one fourth of the
percentage for other sectors, for abrasive blasting and coal-fired
power plants) would be partially or wholly negated in the absence of
engineering controls that would reduce both airborne and surface dust
levels. The Agency's high estimate (90 percent for all sectors except
abrasive blasting and coal fired power plants, 22.5 percent for
abrasive blasting and coal-fired power plants) of the proportion of
remaining CBD cases eliminable by ancillary provisions is based on data
from a facility with average exposure levels of less than 0.2 µg/
m3\.
Based on these considerations, OSHA finds that the ancillary-
provisions-only approach is not one that is likely to maximize net
benefits. The cost savings, if any, are estimated to be small, and the
difficult-to-measure declines in benefits could be substantial.
(2) A Method-of-Compliance Alternative
Paragraph (f)(2)(i) of the final standards contains requirements
for the implementation of engineering and work practice controls to
minimize beryllium exposures in general industry, maritime, and
construction. For each operation in a beryllium work area in general
industry or where exposures are or can reasonably be expected to be
above the action level in shipyards or construction, employers must
ensure that one or more of the following are in place to minimize
employee exposure: Material and/or process substitution; isolation,
such as ventilated partial or full enclosures; local exhaust
ventilation; or process controls, such as wet methods and automation.
Employers are exempt from using these methods only when they can show
that such methods are not feasible or where exposures are below the
action level based on two exposure samples taken at least seven days
apart.
OSHA believes that the methods outlined in paragraph (f)(2)(i)
provide the most reliable means to control variability in exposure
levels. However, OSHA also recognizes that the requirements of
paragraph (f)(2)(i) are not typical of OSHA standards, which usually
require engineering controls
only where exposures exceed the TWA PEL or STEL. The Agency therefore
also considered Regulatory Alternative #6, which would drop the
provisions of (f)(2)(i) from the final standard and make conforming
edits to paragraphs (f)(2)(ii) and (iii). This regulatory alternative
does not eliminate the need for engineering controls to comply with the
final TWA PEL and STEL, but does eliminate the requirement to use one
or more of the specified engineering or work practice controls where
exposures equal or exceed the action level. As shown in Table VIII-15,
Regulatory Alternative #6 would decrease the annualized cost of the
final rule by $606,706 using a discount rate of 3 percent and by
$638,100 using a discount rate of 7 percent.
In the PEA, OSHA had been unable to estimate the benefits of this
alternative and invited public comment. The Agency did not receive
public comment and therefore has not estimated the change in benefits
resulting from Regulatory Alternative #6.
[GRAPHIC] [TIFF OMITTED] TR09JA17.056
(4) Regulatory Alternatives That Affect Ancillary Provisions
The final standard contains several ancillary provisions
(provisions other than the exposure limits), including requirements for
exposure assessment, medical surveillance, medical removal, training,
competent person, and regulated areas or access control. As reported in
Chapter V of the FEA, these ancillary provisions account for $61.3
million (about 83 percent) of the total annualized costs of the rule
($73.4 million) using a 3 percent discount rate. The most expensive of
the ancillary provisions are the requirements for housekeeping and
exposure monitoring, with annualized costs of $22.8 million and $13.7
million, respectively, at a 3 percent discount rate.
OSHA's reasons for including each of the final ancillary provisions
are explained in Section XVI of the preamble, Summary and Explanation
of the Standards.
OSHA has examined a variety of regulatory alternatives involving
changes to one or more of the final ancillary provisions. The
incremental cost of each of these regulatory alternatives and its
impact on the total costs of the final rule are summarized in Table
VIII-16 at the end of this section. OSHA has determined that several of
these ancillary provisions will increase the benefits of the final
rule, for example, by helping to ensure the TWA PEL is not exceeded or
by lowering the risks to workers given the significant risk remaining
at the final TWA PEL. However, except for Regulatory Alternative #7
(involving the elimination of all ancillary provisions), OSHA did not
estimate changes in monetized benefits for the regulatory alternatives
that affect ancillary provisions. Two regulatory alternatives that
involve all ancillary provisions are presented below (#7 and #8),
followed by regulatory alternatives for exposure monitoring (#9, #10,
and #11), for regulated areas (#12), for personal protective clothing
and equipment (#13), for medical surveillance (#14 through #20), and
for medical removal protection (#22).
All Ancillary Provisions
The SBAR Panel recommended that OSHA analyze a PEL-only standard as
a regulatory alternative. The Panel also recommended that OSHA consider
not applying ancillary provisions of the standard where exposure levels
are low so as to minimize costs for small businesses (SBAR, 2008). In
response to these recommendations, OSHA analyzed Regulatory Alternative
#7, a PEL-only standard, and Regulatory Alternative #8, which would
apply ancillary provisions of the beryllium standard only where
exposures exceed the final TWA PEL of 0.2 μg/m3\ or the final STEL
of 2.0 μg/m3\.
Regulatory Alternative #7 would only update 1910.1000 Tables Z-1
and Z-2, so that the final TWA PEL and STEL would apply to all workers
in general industry, construction, and maritime. This alternative would
eliminate all of the ancillary provisions of the final rule, including
exposure assessment, medical surveillance, medical removal protection,
PPE, housekeeping, training, competent person, and regulated areas or
access control. Under this regulatory alternative, OSHA estimates that
the costs for the final ancillary provisions of the rule (estimated at
$61.4 million annually at a 3 percent discount rate) would be
eliminated. In order to meet the PELs, employers would still commonly
need to do monitoring, train workers on the use of controls, and set up
some kind of regulated areas to indicate where respirator use would be
required. It is also likely that, under this alternative, many
employers would follow the recommendations of Materion and the United
Steelworkers to provide medical surveillance, PPE, and other protective
measures for their workers (Materion and United Steelworkers, 2012).
OSHA has not attempted to estimate the extent to which these ancillary
provision costs would be incurred if they were not formally required or
whether any of
these costs under Regulatory Alternative #7 would reasonably be
attributable to the final rule. The total costs for this alternative
are $12.5 million at a 3% discount rate and $13.5 million at a 7%
discount rate.
OSHA has also estimated the effect of this regulatory alternative
on the benefits of the rule, presented in Table VIII-16. As a result of
eliminating all of the ancillary provisions, annualized benefits are
estimated to decrease 71 percent, relative to the final rule, from
$560.9 million to $211.9 million, using a 3 percent discount rate, and
from $249.1 million to $94.0 million using a 7 percent discount rate.
This estimate follows from OSHA's analysis of benefits in Chapter VII
of the FEA, which found that about 68 percent of the benefits of the
final rule, evaluated at their mid-point value, were attributable to
the combination of the ancillary provisions. As these estimates show,
OSHA expects that the benefits estimated under the final rule will not
be fully achieved if employers do not implement the ancillary
provisions of the final rule.
Both industry and worker groups have recognized that a
comprehensive standard is needed to protect workers exposed to
beryllium. The stakeholders' recommended standard--that representatives
of Materion, the primary beryllium producer, and the United
Steelworkers union provided to OSHA--confirms the importance of
ancillary provisions in protecting workers from the harmful effects of
beryllium exposure (Materion and United Steelworkers, 2012). Ancillary
provisions such as personal protective clothing and equipment,
regulated areas, medical surveillance, hygiene areas, housekeeping
requirements, and hazard communication all serve to reduce the risks to
beryllium-exposed workers beyond that which the final TWA PEL alone
could achieve.
Under Regulatory Alternative #8, several ancillary provisions that
the current final rule would require under a variety of exposure
conditions (e.g., dermal contact, any airborne exposure, exposure at or
above the action level) would instead only apply where exposure levels
exceed the TWA PEL or STEL.
Regulatory Alternative #8 affects the following provisions of the
final standard:
--Exposure monitoring: Whereas the scheduled monitoring option of the
final standards requires monitoring every six months when exposure
levels are at or above the action level and at or below the TWA PEL and
every three months when exposure levels exceed the TWA PEL, Regulatory
Alternative #8 would require annual exposure monitoring where exposure
levels exceed the TWA PEL or STEL;
[cir] Written exposure control plan: Whereas the final standards
require written exposure control plans to be maintained in any facility
covered by the standard, Regulatory Alternative #8 would require only
facilities with exposures above the TWA PEL or STEL to maintain a plan;
[cir] PPE: Whereas the final standards require PPE when airborne
exposure to beryllium exceeds, or can reasonably be expected to exceed,
the PEL or STEL, and where there is a reasonable expectation of dermal
contact with beryllium, Alternative #8 would require PPE only for
employees exposed above the TWA PEL or STEL;
[cir] Medical Surveillance: Whereas the final standard's medical
surveillance provisions require employers to offer medical surveillance
to employees exposed above the action level for 30 days per year,
showing signs or symptoms of CBD, exposed to beryllium in an emergency,
or when recommended by a medical opinion, Alternative #8 would require
surveillance only for those employees exposed above the TWA PEL or
STEL.
To estimate the cost savings for this alternative, OSHA re-
estimated the group of workers that would fall under the above
provisions, with results presented in Table VIII-16. Combining these
various adjustments along with associated unit costs, OSHA estimates
that, under this regulatory alternative, the costs for the final rule
would decline from $73.9 million to $35.8 million, using a 3 percent
discount rate, and from $76.6 million to $37.9 million, using a 7
percent discount rate.
The Agency has not quantified the impact of this alternative on the
benefits of the rule. However, ancillary provisions that offer
protective measures to workers exposed below the final TWA PEL, such as
personal protective clothing and equipment, beryllium work areas,
hygiene areas, housekeeping requirements, and hazard communication, all
serve to reduce the risks to beryllium-exposed workers beyond that
which the final TWA PEL and STEL could achieve.
The remainder of this chapter discusses additional regulatory
alternatives that apply to individual ancillary provisions.
Exposure Monitoring
Paragraph (d) of the final standard, Exposure Assessment, allows
employers to choose either the performance option or scheduled
monitoring. The scheduled monitoring option requires semi-annual
monitoring for those workers exposed at or above the action level but
at or below the PEL and quarterly exposure monitoring for those workers
exposed above the PEL. The rationale for this provision is provided in
the preamble discussion of paragraph (a) in Section XVI, Summary and
Explanation of the Standards.
OSHA has examined three regulatory alternatives that would modify
the requirements of periodic monitoring in the final rule. Under
Regulatory Alternative #9, employers would be required to perform
periodic exposure monitoring annually when exposures are at or above
the action level or above the STEL, but at or below the TWA PEL. As
shown in Table VIII-16, Regulatory Alternative #9 would decrease the
annualized cost of the final rule by about $4.3 million using either a
3 percent or 7 percent discount rate.
Under Regulatory Alternative #10, employers would be required to
perform periodic exposure monitoring annually when exposures are at or
above the action level. As shown in Table VIII-16, Regulatory
Alternative #10 would decrease the annualized cost of the final rule by
about $4.9 million using either a 3 percent or 7 percent discount rate.
Under Regulatory Alternative #11, employers would be required to
perform annual exposure monitoring where exposures are at or above the
action level but at or below the TWA PEL and STEL. When exposures are
above the TWA PEL, no periodic monitoring would be required. As shown
in Table VIII-16, Regulatory Alternative #11 would decrease the
annualized cost of the final rule by about $5.0 million using either a
3 percent or 7 percent discount rate. OSHA is unable to quantify the
effect of this change on benefits but has judged the alternative
adopted necessary and protective.
Regulated Areas
Final paragraph (e) for General Industry requires employers to
establish and maintain beryllium work areas in any work area containing
a process or operation that can release beryllium where employees are,
or can reasonably be expected to be, exposed to airborne beryllium at
any level or where there is the potential for dermal contact with
beryllium, and regulated areas wherever airborne concentrations of
beryllium exceed, or can reasonably be expected to
exceed, the TWA PEL or STEL. The Shipyards standard also requires
regulated areas. The Construction standard has a comparable competent
person requirement. Employers in General Industry and Shipyards are
required to demarcate regulated areas and limit access to regulated
areas to authorized persons.
The SBAR Panel report recommended that OSHA consider dropping or
limiting the provision for regulated areas (SBAR, 2008). In response to
this recommendation, OSHA examined Regulatory Alternative #12, which
would eliminate the requirement that employers establish regulated
areas in the General Industry and Maritime standards, and eliminate the
competent person requirement in the Construction standard. This
alternative would not eliminate the final requirement to establish
beryllium work areas, where required. As shown in Table VIII-16,
Regulatory Alternative #12 would decrease the annualized cost of the
final rule by about $1.0 million using either a 3 or 7 percent discount
rate.
Personal Protective Clothing and Equipment
Regulatory Alternative #13 would modify the requirements for
personal protective equipment (PPE) by eliminating the requirement for
appropriate PPE whenever there is potential for skin contact with
beryllium or beryllium-contaminated surfaces. This alternative would be
narrower, and thus less protective, than the PPE requirement in the
final standards, which require PPE to be used where airborne exposure
exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL,
or where there is a reasonable expectation of dermal contact with
beryllium.
The economic analysis for the final standard already contains costs
for protective clothing, namely gloves, for all employees who can
reasonably be expected to be have dermal contact with beryllium; thus
OSHA estimated the cost of this alternative as the cost reduction from
not providing gloves under these circumstances. As shown in Table VIII-
16, Regulatory Alternative #13 would decrease the annualized cost of
the final rule by about $481,000 using either a 3 percent or 7 percent
discount rate.
Medical Surveillance
The final requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are or are reasonably expected to be exposed to beryllium
at or above the action level for more than 30 days per year, who show
signs or symptoms of CBD or other beryllium-related health effects, are
exposed to beryllium in an emergency, or whose more recent written
medical opinion required by paragraph (k)(6) or (k)(7) recommends such
surveillance, and (2) low dose CT scans for employees when recommended
by the PLCHP. The final standards require biennial medical exams to be
provided for eligible employees. The standards also require tests for
beryllium sensitization to be provided to eligible employees
biennially.
OSHA estimated in Chapter V of the FEA that the medical
surveillance requirements would apply to 4,528 workers in general
industry, of whom 387 already receive medical surveillance.\35\ In
Chapter V of the FEA, OSHA estimated the costs of medical surveillance
for the remaining 4,141 workers who would now have such protection due
to the final standard. The Agency's final analysis indicates that 4
workers with beryllium sensitization and 6 workers with CBD will be
referred to a CBD diagnostic center annually as a result of this
medical surveillance. Medical surveillance is particularly important
for this rule because beryllium-exposed workers, including many workers
exposed below the final PELs, are at significant risk of illness.\36\
---------------------------------------------------------------------------
\35\ See baseline compliance rates for medical surveillance in
Chapter III of the FEA, Table III-20.
\36\ OSHA did not estimate, and the benefits analysis does not
include, monetized benefits resulting from early discovery of
illness.
---------------------------------------------------------------------------
OSHA has examined four regulatory alternatives (#15, #16, #18, and
#22) that would modify the final rule's requirements for employee
eligibility, the tests that must be offered, and the frequency of
periodic exams. Medical surveillance was a subject of special concern
to SERs during the SBAR Panel process, and the SBAR Panel offered many
comments and recommendations related to medical surveillance for OSHA's
consideration. Some of the Panel's concerns have been partially
addressed in this final rule, which was modified since the SBAR Panel
was convened (see the preamble at Section XVI, Summary and Explanation
of the Standards, for more detailed discussion). Regulatory Alternative
#16 also responds to recommendations by the SBAR Panel to reduce
burdens on small businesses by dropping or reducing the frequency of
medical surveillance requirements.
OSHA has determined that a significant risk of beryllium
sensitization, CBD, and lung cancer exists at exposure levels below the
final TWA PEL and that there is evidence that beryllium sensitization
can occur even from short-term exposures (see the preamble at Section
V, Health Effects, and Section VII, Significance of Risk). The Agency
therefore anticipates that more employees would develop adverse health
effects without receiving the benefits of early intervention in the
disease process because they are not eligible for medical surveillance
(see section XVI of this preamble, the Summary and Explanation for
paragraph (k)).
Regulatory Alternative #15 would decrease eligibility for medical
surveillance to employees who are exposed to beryllium above the final
PEL
To estimate the cost of Regulatory Alternative #15, OSHA assumed
that all workers exposed above the PEL before the final rule would
continue to be exposed after the standard is promulgated. Thus, this
alternative eliminates costs for medical exams for the number of
workers exposed between the action level and the TWA PEL. As shown in
Table VIII-16, Regulatory Alternative #15 would decrease the annualized
cost of the final rule by about $4.5 million using a discount rate of 3
percent, and by about $4.8 million using a discount rate of 7 percent.
In response to concerns raised during the SBAR Panel process about
testing requirements, OSHA considered two regulatory alternatives that
would provide greater flexibility in the program of tests provided as
part of an employer's medical surveillance program. Under Regulatory
Alternative #16, employers would not be required to offer employees
testing for beryllium sensitization. As shown in Table VIII-16, this
alternative would decrease the annualized cost of the final rule by
about $2.4 million using either a 3 percent or 7 percent discount rate.
Regulatory Alternative #18 would eliminate the CT scan requirement
from the final rule. This alternative would decrease the annualized
cost of the final rule by about $613,000 using a discount rate of 3
percent, and by about $643,000 using a discount rate of 7 percent.
Medical Removal
Under paragraph (l) of the final standard, Medical Removal,
employees in jobs with exposure at or above the action level become
eligible for medical removal when they provide their employers with a
written medical report indicating they are diagnosed with CBD or
confirmed positive for beryllium sensitization, or if a written medical
opinion recommends medical removal
in accordance with the medical surveillance paragraph of the standards.
When an employee chooses removal, the employer is required to remove
the employee to comparable work in an environment where beryllium
exposure is below the action level if such work is available and the
employee is either already qualified or can be trained within one
month. If comparable work is not available, the employer must place the
employee on paid leave for six months or until comparable work becomes
available (whichever comes first). Or, rather than choosing removal, an
eligible employee could choose to remain in a job with exposure at or
above the action level, in which case the employer would have to
provide, and the employee would have to use, a respirator.
The SBAR Panel report included a recommendation that OSHA give
careful consideration to the impacts that an MRP requirement could have
on small businesses (SBAR, 2008). In response to this recommendation,
OSHA analyzed Regulatory Alternative #22, which would remove the final
requirement that employers offer MRP. As shown in Table VIII-16, this
alternative would decrease the annualized cost of the final rule by
about $1.2 million using a discount rate of 3 percent, and by about
$1.3 million using a discount rate of 7 percent.
[GRAPHIC] [TIFF OMITTED] TR09JA17.057
SBAR Panel
Table VIII-17 lists all of the SBAR Panel recommendations and
OSHA's response to those recommendations.
Table VIII-17: SBAR Panel Recommendations and OSHA Responses
------------------------------------------------------------------------
Panel recommendation OSHA response
------------------------------------------------------------------------
The Panel recommends that OSHA evaluate OSHA has reviewed its cost
carefully the costs and technological estimates and the
feasibility of engineering controls at technological feasibility of
all PEL options, especially those at engineering controls at
the lowest levels. various PEL levels. These
issues are discussed in the
Regulatory Alternatives
Chapter.
The Panel recommends that OSHA consider OSHA has removed the initial
alternatives that would alleviate the exposure monitoring
need for monitoring in operations with requirement for workers likely
exposures far below the PEL. The Panel to be exposed to beryllium by
also recommends that OSHA consider skin or eye contact through
explaining more clearly how employers routine handling of beryllium
may use "objective data" to estimate powders or dusts or contact
exposures. Although the draft proposal with contaminated surfaces.
contains a provision allowing The periodic monitoring
employers to initially estimate requirement presented in the
exposures using "objective data" SBAR Panel report required
(e.g., data showing that the action monitoring every 6 months for
level is unlikely to be exceeded for airborne levels at or above
the kinds of process or operations an the action level but below the
employer has), the SERs did not appear PEL, and every 3 months for
to have fully understood how this exposures at or above the PEL.
alternative may be used. The final standard, in line
with OSHA's normal practice,
requires exposure monitoring
every three months for levels
above the PEL or STEL and
every six months for exposures
between the action level and
the PEL. In the preamble to
the final standard, OSHA
provides further explanation
on the use of objective data,
which would exempt employers
from the requirements of the
final rule.
These issues are discussed in
the preamble at Section XVI,
Summary and Explanation of the
Standards, (d): Exposure
Monitoring.
The Panel recommends that OSHA consider In the preamble to the final
providing some type of guidance to standards, OSHA discusses the
describe how to use objective data to issue of objective data. While
estimate exposures in lieu of OSHA recognizes that some
conducting personal sampling. establishments will have
Using objective data could provide objective data, for purposes
significant regulatory relief to of estimating the cost of this
several industries where airborne rule, the Agency is assuming
exposures are currently reported by that no establishments will
SERs to be well below even the lowest use objective data. The Agency
PEL option. In particular, since recognizes that this will
several ancillary provisions, which overestimate costs.
may have significant costs for small The use of objective data is
entities may be triggered by the PEL discussed in the preamble at
or an action level, OSHA should Section XVI, Summary and
consider encouraging and simplifying Explanation of the Standards,
the development of objective data from (d): Exposure Monitoring.
a variety of sources.
The Panel recommends that OSHA revisit SERs with very low exposure
its analysis of the costs of regulated levels or only occasional work
areas if a very low PEL is proposed. with beryllium will not be
Drop or limit the provision for required to have regulated
regulated areas: SERs with very low areas unless exposures are
exposure levels or only occasional above the final PEL of 0.2
work with beryllium questioned the μg/m3\.
need for separating areas of work by The final standards for general
exposure level. Segregating machines industry and maritime require
or operations, SERs said, would affect the employer to establish and
productivity and flexibility. Until maintain a regulated area
the health risks of beryllium are wherever employees are, or can
known in their industries, SERs be expected to be, exposed to
challenged the need for regulated airborne beryllium at levels
areas. above the PEL of 0.2 μg/
m3\. There is no regulated
area requirement in
Construction.
The Panel recommends that OSHA revisit In General industry employers
its cost model for hygiene areas to must ensure that employees who
reflect SERs' comments that estimated have dermal contact with
costs are too low and more carefully beryllium wash any exposed
consider the opportunity costs of skin at the end of the
using space for hygiene areas where activity, process, or work
SERs report they have no unused space shift and prior to eating,
in their physical plant for them. The drinking, smoking, chewing
Panel also recommends that OSHA tobacco or gum, applying
consider more clearly defining the cosmetics, or using the
triggers (skin exposure and toilet. In General Industry,
contaminated surfaces) for the hygiene although there is a shower
areas provisions. In addition, the requirement, OSHA has
Panel recommends that OSHA consider determined that establishments
alternative requirements for hygiene required to have showers will
areas dependent on airborne exposure already have them, and
levels or types of processes. Such employers will not have to
alternatives might include, for install showers to comply with
example, hand washing facilities in the beryllium standard (Please
lieu of showers in particular cases or see the Hygiene Areas and
different hygiene area triggers where Practices section in Chapter V
exposure levels are very low. of the FEA). In Construction
and Maritime, for each
employee required to use
personal protective clothing
or equipment, the employer
must ensure that employees who
have dermal contact with
beryllium wash any exposed
skin at the end of the
activity, process, or work
shift and prior to eating,
drinking, smoking, chewing
tobacco or gum, applying
cosmetics, or using the
toilet. For Construction and
Maritime, language involving
showers has been removed but
employers are still required
to provide change rooms. Where
personal protective clothing
or equipment must be used, the
employer must provide washing
facilities. The standards do
not require that eating and
drinking areas be provided,
but impose requirements when
the employer chooses to have
eating and drinking areas.
Change rooms have been costed
in general industry for
employees who work in a
beryllium work area and in
construction and maritime for
employees who required to use
personal protective clothing
or equipment. The Agency has
determined that the long-term
rental of modular units is
representative of costs for a
range of reasonable approaches
to comply with the change room
part of the provision.
Alternatively, employers could
renovate and rearrange their
work areas in order to meet
the requirements of this
provision.
The Panel recommends that OSHA consider In the preamble to the final
clearly explaining the purpose of the rule, OSHA has clarified the
housekeeping provision and describing purpose of the housekeeping
what affected employers must do to provision. However, due to the
achieve it. variety of work settings in
For example, OSHA should consider which beryllium is used, OSHA
explaining more specifically what has concluded that a highly
surfaces need to be cleaned and how specific directive in the
frequently they need to be cleaned. preamble on what surfaces need
The Panel recommends that the Agency to be cleaned, and how
consider providing guidance in some frequently, would not provide
form so that employers understand what effective guidance to
they must do. The Panel also businesses. Instead, at the
recommends that once the requirements suggestion of industry and
are clarified that the Agency re- union stakeholders (Materion
analyze its cost estimates. and USW, 2012), OSHA's final
The Panel also recommends that OSHA standards include a more
reconsider whether the risk and cost flexible requirement for
of all parts of the medical employers to develop a written
surveillance provisions are exposure control plan specific
appropriate where exposure levels are to their facilities. In
very low. In that context, the Panel general industry, the employer
recommends that OSHA should also must establish procedures to
consider the special problems and maintain all surfaces in
costs to small businesses that up beryllium work areas as free
until now may not have had to provide as practicable of beryllium as
or manage the various parts of an required by the written
occupational health standard or exposure control plan. Other
program. than requirements pertaining
to eating and drinking areas,
there are no requirements to
maintain surface cleanliness
in construction or maritime.
These issues are discussed in
the preamble at Section XVI,
Summary and Explanation of the
Standards, (f) Methods of
Compliance and (j)
Housekeeping. The adoption of
Regulatory Alternative #20 in
the PEA reduced the frequency
of physical examinations from
annual to biennial, matching
the frequency of BeLPT testing
in the final rule.
These alternatives for medical
surveillance are discussed in
the Regulatory Alternatives
Chapter, Chapter VIII and in
the preamble at section XVI,
Summary and Explanation of the
Standards, (k) Medical
Surveillance.
The Panel recommends that OSHA consider Under the final standards, skin
that small entities may lack the exposure is not a trigger for
flexibility and resources to provide medical removal (unlike the
alternative jobs to employees who test draft version used for the
positive for the BeLPT, and whether SBAR Panel). Employees are
medical removal protection (MRP) only eligible for medical
achieves its intended purpose given removal if they are in a job
the course of beryllium disease. The with airborne exposure at or
Panel also recommends that if MRP is above the action level and
implemented, that its effects on the provide the employer with a
viability of very small firms with a written medical report
sensitized employee be considered confirming that they are
carefully. sensitized or have been
diagnosed with CBD, or that
the physician recommends
removal, or if the employer
receives a written medical
opinion recommending removal
of the employee. After
becoming eligible for medical
removal an employee may choose
to remain in a job with
exposure at or above the
action level, provided that
the employer provides and the
employee wears a respirator in
accordance with the
Respiratory Protection
standard (29 CFR 1910.134). If
the employee chooses removal,
the employer is only required
to place the employee in
comparable work with exposure
below the action level if such
work is available; if such
work is not available, the
employer may place the
employee on paid leave for six
months or until such work
becomes available, whichever
comes first.
OSHA discusses the basis of the
provision in the preamble at
Section XVI, Summary and
Explanation of the Standards,
(l) Medical Removal
Protection. OSHA provides an
analysis of costs and economic
impacts of the provision in
the FEA in Chapter V and
Chapter VI, respectively.
The Panel recommends that OSHA consider As stated above, the triggers
more clearly defining the trigger for medical surveillance in
mechanisms for medical surveillance the final standard have
and also consider additional or changed from those presented
alternative triggers--such as limiting to the SBAR Panel. Whereas the
the BeLPT to a narrower range of draft standard presented at
exposure scenarios and reducing the the SBAR Panel required
frequency of BeLPT tests and physical medical surveillance for
exams. The Panel also recommends that employees with skin contact--
OSHA reconsider whether the risk and potentially applying to
cost of all parts of the medical employees with any level of
surveillance provisions are airborne exposure--the final
appropriate where exposure levels are standard ties medical
very low. In that context, the Panel surveillance to exposures at
recommends that OSHA should also or above the action level for
consider the special problems and more than 30 days per year (or
costs to small businesses that up signs or symptoms of beryllium-
until now may not have had to provide related health effects,
or manage the various parts of an emergency exposure, or a
occupational health standard or medical opinion recommending
program. medical surveillance on the
basis of a CBD or
sensitization diagnosis).
Thus, small businesses with
exposures below the final
action level would not need to
provide or manage medical
surveillance for their
employees unless employees
develop signs or symptoms of
beryllium-related health
effects or are exposed in
emergencies.
These issues are discussed in
the preamble at section XVI,
Summary and Explanation of the
Standards, (k) Medical
Surveillance.
The Panel recommends that the Agency, OSHA has reviewed the possible
in evaluating the economic feasibility effects of the final
of a potential regulation, consider regulation on market demand
not only the impacts of estimated and/or foreign production, in
costs on affected establishments, but addition to the Agency's usual
also the effects of the possible measures of economic impact
outcomes cited by SERs: Loss of market (costs as a fraction of
demand, the loss of market to foreign revenues and profits). This
competitors, and of U.S. production discussion can be found in
being moved abroad by U.S. firms. The Chapter VI of the FEA
Panel also recommends that OSHA (entitled Economic Feasibility
consider the potential burdens on Analysis and Regulatory
small businesses of dealing with Flexibility Determination).
employees who have a positive test
from the BeLPT. OSHA may wish to
address this issue by examining the
experience of small businesses that
currently provide the BeLPT test.
The Panel recommends that OSHA consider The provisions in the standard
seeking ways of minimizing costs for presented in the SBAR panel
small businesses where the exposure report applied to all
levels may be very low. Clarifying the employees, whereas the final
use of objective data, in particular, standard's ancillary
may allow industries and provisions are only applied to
establishments with very low exposures employees in work areas who
to reduce their costs and involvement are, or can reasonably be
with many provisions of a standard. expected to be, exposed to
The Panel also recommends that the airborne beryllium. In
Agency consider tiering the addition, the scope of the
application of ancillary provisions of final standard includes
the standard according to exposure several limitations. Whereas
levels and consider a more limited or the standard presented in the
narrowed scope of industries. SBAR panel report covered
beryllium in all forms and
compounds in general industry,
construction, and maritime,
the scope of the final
standard (1) does not apply to
beryllium-containing articles
that the employer does not
process; and (2) does not
apply to materials that
contain less than 0.1%
beryllium by weight if the
employer has objective data
demonstrating that employee
exposure to beryllium will
remain below the action level
as an 8-hour TWA under any
foreseeable conditions.
In the preamble to the final
standard, OSHA has clarified
the circumstances under which
an employer may use historical
and objective data in lieu of
initial monitoring (Section
XVI, Summary and Explanation
of the Standards, (d) Exposure
Monitoring).
OSHA also considered two
Regulatory Alternatives that
would reduce the impact of
ancillary alternatives on
employers, including small
businesses. Regulatory
Alternative #7, a PEL-only
standard, would drop all
ancillary provisions from the
standard. Regulatory
Alternative #8 would limit the
application of several
ancillary provisions,
including Exposure Monitoring,
the written exposure control
plan section of Method of
Compliance, PPE, Housekeeping,
and Medical Surveillance, to
operations or employees with
exposure levels exceeding the
TWA PEL or STEL.
These alternatives are
discussed in the Regulatory
Alternatives, Chapter VIII of
the FEA.
The Panel recommends that OSHA provide The explanation and analysis
an explanation and analysis for all for all health outcomes (and
health outcomes (and their scientific their scientific basis) are
basis) upon which it is regulating discussed in the preamble to
employee exposure to beryllium. The the final standard at Section
Panel also recommends that OSHA V, Health Effects, and Section
consider to what extent a very low PEL VI, Risk Assessment. They are
(and lower action level) may result in also reviewed in the preamble
increased costs of ancillary to the final standard at
provisions to small entities (without Section VII, Significance of
affecting airborne employee Risk, and the Benefits Chapter
exposures). Since in the draft of the FEA.
proposal the PEL and action level are As discussed above, OSHA
critical triggers, the Panel considered Regulatory
recommends that OSHA consider Alternatives #7 and #8, which
alternate action levels, including an would eliminate or reduce the
action level set at the PEL, if a very impact of ancillary provisions
low PEL is proposed. on employers, respectively.
These alternatives are
discussed in Chapter VIII of
the FEA.
The Panel recommends that OSHA consider OSHA has removed skin exposure
more clearly and thoroughly defining as a trigger for several
the triggers for ancillary provisions, ancillary provisions in the
particularly the skin exposure final standard, including
trigger. In addition, the Panel Exposure Assessment and
recommends that OSHA clearly explain Medical Surveillance. For each
the basis and need for small entities employee working in a
to comply with ancillary provisions. beryllium work area in general
The Panel also recommends that OSHA industry, and for each
consider narrowing the trigger related employee required to use
to skin and contamination to capture personal protective clothing
only those situations where surfaces or equipment in construction
and surface dust may contain beryllium and maritime, the employer
in a concentration that is significant must ensure that employees who
enough to pose any risk--or limiting have dermal contact with
the application of the trigger for beryllium wash any exposed
some ancillary provisions. skin at the end of the
activity, process, or work
shift and prior to eating,
drinking, smoking, chewing
tobacco or gum, applying
cosmetics, or using the
toilet. In addition, the
potential for dermal contact
with beryllium triggers
requirements related to
beryllium work areas, the
written exposure control plan,
washing facilities,
housekeeping and training: For
some ancillary provisions,
including PPE and
Housekeeping, the requirements
are triggered by visible
contamination with beryllium
or dermal contact with
beryllium.
In Construction and Maritime,
for each employee required to
use personal protective
clothing or equipment, the
employer must ensure that
employees who have dermal
contact with beryllium wash
any exposed skin at the end of
the activity, process, or work
shift and prior to eating,
drinking, smoking, chewing
tobacco or gum, applying
cosmetics, or using the
toilet. For Construction and
Maritime, language involving
showers has been removed and
employers are required to
provide change rooms for
employees required to use
personal protective clothing
or equipment and required to
remove their personal
clothing. Where dermal contact
occurs, employers must provide
washing facilities.
These requirements are
discussed in the preamble at
Section XVI, Summary and
Explanation of the Standards.
The Agency has also explained
the basis and need for
compliance with ancillary
provisions in the preamble at
Section XVI, Summary and
Explanation of the Standards.
Several SERs said that OSHA should In the Technological
first assume the burden of describing Feasibility Analysis presented
the exposure level in each industry in the FEA, OSHA has described
rather than employers doing so. Others the baseline exposure levels
said that the Agency should accept in each industry or
exposure determinations made on an application group.
industry-wide basis, especially where In the preamble to the final
exposures were far below the PEL standards, OSHA discusses the
options under consideration. issue of objective data. While
As noted above, the Panel recommends OSHA recognizes that some
that OSHA consider alternatives that establishments will have
would alleviate the need for objective data, for purposes
monitoring in operations or processes of the economic analysis, the
with exposures far below the PEL. The Agency is choosing to assume
use of objective data is a principal that no establishments will
method for industries with low use objective data. The Agency
exposures to satisfy compliance with a recognizes that this will
proposed standard. The Panel overestimate costs.
recommends that OSHA consider
providing some guidance to small
entities in the use of objective data.
The Panel recommends that OSHA consider OSHA has provided discussion of
more fully evaluating whether the the BeLPT in the preamble to
BeLPT is suitable as a test for the final rule at section V,
beryllium sensitization in an OSHA Health Effects; and in the
standard and respond to the points preamble at section XVI,
raised by the SERs about its efficacy. Summary and Explanation of the
In addition, the Agency should Standards, (b) Definitions and
consider the availability of other (k) Medical Surveillance. In
tests under development for detecting the regulatory text, OSHA has
beryllium sensitization and not limit clarified that a test for
either employers' choices or new beryllium sensitization other
science and technology in this area. than the BeLPT may be used in
Finally, the Panel recommends that lieu of the BeLPT if a more
OSHA re-consider the trigger for reliable and accurate
medical surveillance where exposures diagnostic test is developed.
are low and consider if there are As stated above, the triggers
appropriate alternatives. for medical surveillance in
the final standard have
changed from those presented
to the SBAR Panel. Whereas the
draft standard presented
during the SBREFA process
required medical surveillance
for employees with skin
contact--potentially applying
to employees with any level of
airborne exposure--the final
standard ties medical
surveillance to exposures
above the final action level
of 0.1 μg/m3\ (or signs or
symptoms of beryllium-related
health effects, emergency
exposure, or a medical opinion
recommending medical
surveillance on the basis of a
CBD or sensitization
diagnosis). The triggers for
medical surveillance are
discussed in the preamble at
section XVI, Summary and
Explanation of the Standards,
(k) Medical Surveillance.
OSHA has considered Regulatory
Alternative #16, where
employers would not be
required to offer employees a
BeLPT that tests for beryllium
sensitization. from the final
standard. This alternative is
discussed in the Regulatory
Alternatives Chapter and in in
the preamble at Section XVI,
Summary and Explanation of the
Final Standard, (k) Medical
Surveillance.
Seeking ways of minimizing costs to low- The standard presented in the
risk processes and operations: OSHA SBAR panel report had skin
should consider alternatives for exposure as a trigger. The
minimizing costs to industries, final standards require PPE
operations, or processes that have low when there is a reasonable
exposures. Such alternatives may expectation of dermal contact
include, but not be limited to: with beryllium. The employer
Encouraging the use of objective data must ensure that employees who
by such mechanisms as providing have dermal contact with
guidance for objective data; assuring beryllium wash any exposed
that triggers for skin exposure and skin at the end of the
surface contamination are clear and do activity, process, or work
not pull in low-risk operations; shift and prior to eating,
providing guidance on least-cost ways drinking, smoking, chewing
for low risk facilities to determine tobacco or gum, applying
what provisions of the standard they cosmetics, or using the
need to comply with; and considering toilet. OSHA uses an exposure
ways to limit the scope of the profile to determine which
standard if it can be ascertained that workers will be affected by
certain processes do not represent a the standards. As a result, in
significant risk. General Industry and Maritime,
the final standards require
regulated areas where
exposures can exceed the PEL
or STEL. In General Industry,
beryllium work areas must be
established in areas that
contain a process or operation
that can release beryllium
where employees are, or can
reasonably be expected to be,
exposed to airborne beryllium
at any level or where there is
the potential for dermal
contact with beryllium.
In Construction, the written
exposure control plan must
contain procedures used to
restrict access to work areas
when airborne exposures are,
or can reasonably be expected
to be, above the TWA PEL or
STEL, and the competent person
must implement the plan.
In addition, the scope of the
final standards includes
several limitations. Whereas
the standard presented in the
SBAR panel report covered
beryllium in all forms and
compounds in general industry,
construction, and maritime,
the scope of the final
standard (1) does not apply to
beryllium-containing articles
that the employer does not
process; and (2) does not
apply to materials that
contain less than 0.1%
beryllium by weight where the
employer has objective data
demonstrating that employee
exposure to beryllium will
remain below the action level
as an 8-hour TWA under any
foreseeable conditions. In the
preamble to the final
standards, OSHA discusses the
issue of objective data. While
OSHA recognizes that some
establishments will have
objective data, for purposes
of this rule, the Agency is
choosing to assume that no
establishments will use
objective data. The Agency
recognizes that this will
overestimate costs.
PEL-only standard: One SER recommended OSHA considered Regulatory
a PEL-only standard. This would Alternative #7, a PEL-only
protect employees from airborne standard. This alternative is
exposure risks while relieving the discussed in Chapter VIII of
beryllium industry of the cost of the the FEA.
ancillary provisions. The Panel
recommends that OSHA, consistent with
its statutory obligations, analyze
this alternative.
Alternative triggers for ancillary OSHA has removed skin exposure
provisions: The Panel recommends that as a trigger for several
OSHA clarify and consider eliminating ancillary provisions in the
or narrowing the triggers for final standard, including
ancillary provisions associated with Exposure Monitoring and
skin exposure or contamination. In Medical Surveillance. In
addition, the Panel recommends that General Industry, the employer
OSHA should consider trying ancillary must ensure that employees who
provisions dependent on exposure have dermal contact with
rather than have these provisions all beryllium wash any exposed
take effect with the same trigger. If skin at the end of the
OSHA does rely on a trigger related to activity, process, or work
skin exposure, OSHA should thoroughly shift and prior to eating,
explain and justify this approach drinking, smoking, chewing
based on an analysis of the scientific tobacco or gum, applying
or research literature that shows a cosmetics, or using the
risk of sensitization via exposure to toilet.
skin. If OSHA adopts a relatively low In Construction and Maritime,
PEL, OSHA should consider the effects for each employee required to
of alternative airborne action levels use personal protective
in pulling in many low risk facilities clothing or equipment, the
that may be unlikely to exceed the employer must ensure that
PEL--and consider using only the PEL employees who have dermal
as a trigger at very low levels. contact with beryllium wash
any exposed skin at the end of
the activity, process, or work
shift and prior to eating,
drinking, smoking, chewing
tobacco or gum, applying
cosmetics, or using the
toilet.
In addition, the language of
the final standard regarding
skin exposure has changed: For
some ancillary provisions,
including PPE and
Housekeeping, the requirements
are triggered by visible
contamination with beryllium
or skin contact with beryllium
compounds.
These requirements are
discussed in the preamble at
Section XVI, Summary and
Explanation of the Standards.
OSHA has explained the
scientific basis for
minimizing skin exposure to
beryllium in the preamble to
the final rule at Section V,
Health Effects, and explains
the basis for specific
ancillary provisions related
to skin exposure in the
preamble at Section XVI,
Summary and Explanation of the
Standards. In the final
standards, the application of
ancillary provisions is
dependent on exposure, and not
all provisions take effect
with the same trigger. A
number of requirements are
triggered by exposures (or a
reasonable expectation of
exposures) above the PEL or
action level (AL). As
discussed above, OSHA
considered Regulatory
Alternatives #7 and #8, which
would eliminate or reduce the
impact of ancillary provisions
on employers, respectively.
These alternatives are
discussed in Chapter VIII of
the FEA.
Revise the medical surveillance After considering comments from
provisions, including eliminating the SERs, OSHA has revised the
BeLPT: The BeLPT was the most common medical surveillance provision
complaint from SERs. The Panel and removed the skin exposure
recommends that OSHA carefully examine trigger for medical
the value of the BeLPT and consider surveillance. As a result,
whether it should be a requirement of OSHA estimates that the number
a medical surveillance program. The of small-business employees
Panel recommends that OSHA present the requiring a BELPT will be
scientific evidence that supports the substantially reduced.
use of the BeLPT as several SERs were OSHA has provided discussion of
doubtful of its reliability. The Panel the BeLPT in the preamble to
recommends that OSHA also consider the final rule at section V,
reducing the frequency of physicals Health Effects; and in the
and the BeLPT, if these provisions are preamble at section XVI,
included in a proposal. The Panel Summary and Explanation of the
recommends that OSHA also consider a Standards, (b) Definitions and
performance-based medical surveillance (k) Medical Surveillance. In
program, permitting employers in the regulatory text, OSHA has
consultation with physicians and clarified that a test for
health experts to develop appropriate beryllium sensitization other
tests and their frequency. than the BeLPT may be used in
lieu of the BeLPT if a more
reliable and accurate
diagnostic test is developed.
The frequency of periodic BeLPT
testing in the final standard
is biennial, whereas annual
testing was included in the
draft standard presented to
the SBAR Panel.
Regulatory Alternative #20
would reduce the frequency of
physical examinations from
biennial to annual, matching
the frequency of BeLPT testing
in the final rule.
In response to the suggestion
to allow performance-based
medical surveillance, OSHA
considered two regulatory
alternatives that would
provide greater flexibility in
the program of tests provided
as part of an employer's
medical surveillance program.
Regulatory Alternative #16
would eliminate BeLPT testing
requirements from the final
standard. Regulatory
Alternative #18 would
eliminate the CT scan
requirement from the final
standard. These alternatives
are discussed in the
Regulatory Alternatives
Chapter and in the preamble at
Section XVI, Summary and
Explanation of the Standards,
(k) Medical Surveillance.
No medical removal protection (MRP): The final standard includes an
OSHA's draft proposed standard did not MRP provision. OSHA discusses
include any provision for medical the basis of the provision in
removal protection, but OSHA did ask the preamble at Section XVI,
the SERs to comment on MRP as a Summary and Explanation of the
possibility. Based on the SER Standards, (l) Medical Removal
comments, the Panel recommends that if Protection. OSHA provides an
OSHA includes an MRP provision, the analysis of costs and economic
agency provide a thorough analysis of impacts of the provision in
why such a provision is needed, what the FEA in Chapter V and
it might accomplish, and what its full Chapter VI, respectively.
costs and economic impacts on those The Agency considered
small businesses that need to use it Alternative #22, which would
might be. eliminate the MRP requirement
from the standard. This
alternative is discussed in
the Regulatory Alternatives
Chapter and in the preamble at
section XVI, Summary and
Explanation of the Standards,
(l) Medical Removal
Protection.
------------------------------------------------------------------------
IX. OMB Review Under the Paperwork Reduction Act of 1995
Introduction
The three final beryllium standards (collectively "the
standards") for occupational exposure to beryllium--general industry
(29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyard (29
CFR 1915.1024)--contain collection of information (paperwork)
requirements that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C.
3501 et seq, and OMB's regulations at 5 CFR part 1320. The PRA requires
that agencies obtain approval from OMB before conducting any collection
of information (44 U.S.C. 3507). The PRA defines "collection of
information" to mean "the obtaining, causing to be obtained,
soliciting, or requiring the disclosure to third parties or the public,
of facts or opinions by or for an agency, regardless of form or
format" (44 U.S.C. 3502(3)(A)).
In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited
public comments on the Beryllium Standard for General Industry (29 CFR
1910.1024), Information Collection Request (ICR) (paperwork burden hour
and cost analysis) for the proposed rule (80 FR 47555). The Department
submitted this ICR to OMB for review in accordance with 44 U.S.C.
3507(d) on August 7, 2015. A copy of this ICR is available to the
public at http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267).
On October 21, 2015, OMB issued a Notice of Action (NOA) assigning
Beryllium Standard for General Industry new OMB Control Number 1218-
0267 to use in future paperwork submissions involving this rulemaking.
OMB requested that, "Prior to publication of the final rule, the
agency should provide a summary of any comments related to the
information collection and their response, including any changes made
to the ICR as a result of comments. In addition, the agency must enter
the correct burden estimates."
The proposed rule invited the public to submit comments to OMB, in
addition to OSHA, on the proposed collections of information with
regard to the following:
Whether the proposed collections of information are
necessary for the proper performance of the Agency's functions,
including whether the information is useful;
The accuracy of OSHA's estimate of the burden (time and
cost) of the collections of information, including the validity of the
methodology and assumptions used;
The quality, utility, and clarity of the information
collected; and
Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information (78 FR 56438).
No public comments were received specifically in response to the
proposed ICR submitted to OMB for review. However, several public
comments submitted in response to the Notice of Proposed Rulemaking
(NPRM), described earlier in this preamble, substantively addressed
provisions containing collections of information and contained
information relevant to the burden hour and costs analysis. These
comments are addressed in the preamble, and OSHA considered them when
it developed the revised ICR associated with these final standards.
The Department of Labor submitted the final ICR January 9, 2017
containing a full analysis and description of the burden hours and
costs associated with the collections of information of the standards
to OMB for approval. A copy of the ICR is available to the public at
http://www.reginfo.gov. OSHA will publish a separate notice in the
Federal Register that will announce the results of OMB's review. That
notice will also include a list of OMB approved collections of
information and total burden hours and costs imposed by the new
standards.
Under the PRA, Federal agency cannot conduct or sponsor a
collection of information unless it is approved by OMB under the PRA,
and the collection of information notice displays a currently valid OMB
control number (44 U.S.C. 3507(a)(3)). Also, notwithstanding any other
provision of law, no employer shall be subject to penalty for failing
to comply with a collection of information if the collection of
information does not display a currently valid OMB control number (44
U.S.C. 3512). The major collections of information found in the
standards are listed below.
Summary of Information Collection Requirements
The Beryllium standards contain collection of information
requirements which are essential components of the occupational safety
and health standards that will assist both employers and their
employees in identifying the exposures to beryllium and beryllium
compounds, the medical effects of such exposures, and the means to
reduce the risk of overexposures to beryllium and beryllium compounds.
In the final ICR, OSHA has expanded its coverage to include the
construction and shipyard industries--in order to tailor the collection
of information requirements to the circumstances found in these
sectors. The decision to include standards for construction and
shipyards is based on information and comment submitted in response to
the NPRM request for comment, and during the informal public hearing.
1. Title: Beryllium (29 CFR 1910.1024; 29 CFR 1915.1024; 29 CFR
1926. 1124).
2. Type of Review: New.
3. OMB Control Number: 1218-0267.
4. Affected Public: Business or other for-profit. This standard
applies to employers in general industry, shipyard, and construction
who have employees that may have occupational exposures to any form of
beryllium, including compounds and mixtures, except those articles and
materials exempted by paragraphs (a)(2) and (a)(3) of the Final
standard.
5. Number of Respondents: 5,872 affected employers.
6. Frequency of Responses: On occasion; quarterly, semi-annually,
annual; biannual.
7. Number of Responses: 246,433.
8. Average Time per Response: Varies from 5 minutes (.08 hours) for
a clerical worker to generate and maintain an employee medical record,
to more than 8 hours for a human resource manager to develop and
implement a written exposure control plan.
9. Estimated Total Burden Hours: 196,894.
10. Estimated Cost (capital-operation and maintenance):
$46,158,266.
Discussion of Significant Changes in the Collections of Information
Requirements
Below is a summary of the collection of information requirements
contained in the final rule, and a brief description of the most
significant changes between the proposal and the final rule portions of
the regulatory text containing collection of information requirements.
One of the most significant changes between the NPRM and this final
rule is that OSHA extended the scope of the rule so that the most of
the provisions now also apply to construction and shipyard work. As a
result, while most of the provisions are identical across all three
standards (general industry, construction, and shipyards), there are
technically more collections of information. However, for purposes of
the review and explanation that follows, OSHA has focused on the
changes to the general industry provisions and has not separately
identified the additions to the construction and shipyard standard
unless they deviate from the requirements in the general industry
standard. A more detailed discussion of all the changes made to the
proposed rule, including the requirements that include identified
collection of information, is in Section XVIII: Summary and
Explanation. The impact on information collections is also discussed in
more detail in Item 8 of the ICR.
Exposure Assessment
Paragraph (d) sets forth requirements for assessing employee
exposures to beryllium. Consistent with the definition of "airborne
exposure" in paragraph (b) of these standards, exposure monitoring
results must reflect the exposure to airborne beryllium that would
occur if the employee were not using a respirator.
Proposed paragraph (d) used the term "Exposure monitoring." In
the final rule, this term was changed to "Exposure assessment"
throughout the paragraph. This change in the final standards was made
to align the provision's purpose with the broader concept of exposure
assessment beyond conducting air monitoring, including the use of
objective data.
OSHA added a paragraph (d)(2) as an alternative exposure assessment
method to the scheduled monitoring requirements in the proposed rule.
Under this option employers must assess 8-hour TWA exposure and the 15-
minute short term exposure for each employee using any combination of
air monitoring data and objective data sufficient to accurately
characterize airborne exposure to beryllium.
Proposed paragraph (d)(3), Periodic Exposure Monitoring, would have
required employers whose initial monitoring results indicated that
employee's exposures results are at or above the action level and at or
below the TWA PEL to conduct periodic exposure monitoring at least
annually. Final paragraph (d)(3), Scheduled Monitoring Option,
increased the frequency schedule for periodic monitoring and added a
requirement to perform periodic exposure monitoring when exposures are
above the PEL, paragraph (d)(3)(vi) and when exposures are above the
STEL in paragraph (d)(3)(viii).
Proposed paragraph (d)(4) would have required employers to conduct
exposure monitoring within 30 days after a change in production
processes, equipment, materials, personnel, work practices, or control
methods that could reasonably be expected to result in new or
additional exposures. OSHA changed the proposed requirement to require
that employers perform reassessment of exposures when there is a change
in "production, process, control equipment, personnel, or work
practices" that may reasonably be expected to result in new or
additional exposures at or above the action level or STEL. In addition,
OSHA added "at or above the action level or STEL" to final paragraph
(d)(4). In summary, the final rule requires that employers must perform
reassessment of exposures when there is a change in production,
process, control equipment, personnel, or work practices that may
reasonably be expected to result in new or additional exposures at or
above the action level or STEL.
Proposed paragraph (d)(5)(i), Employee Notification of Monitoring
Results, would have required employers in general industry to inform
their employees of results within 15 working days after receiving the
results of any exposure monitoring completed under this standard. Final
paragraph (d)(6), Employee Notification of Assessment Results, requires
that employers in general industry, construction and shipyards inform
their employees of results within 15 working days after completing an
exposure assessment.
Proposed paragraph (d)(5)(ii) (paragraph (d)(6)(ii) of the final
standards) would have required that whenever an exposure assessment
indicates that airborne exposure is above the TWA PEL or STEL, the
employer must include in the written notification the suspected or
known sources of exposure and the corrective action(s) the employer has
taken or will take to reduce exposure to or below the PELs, where
feasible corrective action exists but had not been implemented when the
monitoring was conducted. Final paragraph (d)(6)(ii) removes the
requirement that employers include suspected or known sources of
exposure in the written notification.
Methods of Compliance
Proposed paragraph (f)(1)(i) would have required employers to
establish, implement and maintain a written control plan for beryllium
work areas. OSHA has retained the requirement for a written exposure
control plan and incorporated most provisions of the proposed paragraph
(f)(1)(i) into the final standards for construction and shipyards, with
certain modifications due to the work processes and worksites
particular to these sectors.
Paragraph (f)(1)(i) differs from the proposal in that it requires a
written exposure control plan for each facility, whereas the proposal
would have required a written exposure control plan for beryllium work
areas within each facility. OSHA has modified the requirement of a list
of operations and job titles reasonably expected to have exposure to
include those operations and job titles that are reasonably expected to
have dermal contact with beryllium. Finally, OSHA modified the proposed
requirement to inventory engineering and work practice controls
required by paragraph (f)(2) of this standard to include respiratory
protection.
Paragraph (f)(1)(ii) of the final standards requires the employer
to review and evaluate the effectiveness of each written exposure
control plan at least annually and update it when: (A) Any change in
production processes, materials, equipment, personnel, work practices,
or control methods results or can reasonably be expected to result in
additional or new airborne exposure to beryllium; (B) the employer is
notified that an employee is eligible for medical removal in accordance
with paragraph
(l)(1) of this standard, referred for evaluation at a CBD Diagnostic
Center, or shows signs or symptoms associated with airborne exposure to
or dermal contact with beryllium; or (C) the employer has any reason to
believe that new or additional airborne exposure is occurring or will
occur.
OSHA made several changes to that paragraph. First, OSHA added a
requirement to review and evaluate the effectiveness of each written
exposure control plan at least annually. Second, OSHA changed the
proposed language of (f)(1)(ii)(B) to reflect other changes in the
standard, including a change to ensure that employers are not
automatically notified of cases of sensitization or CBD among their
employees. Third, OSHA modified (f)(1)(ii)(B) to clarify the Agency's
understanding that signs and symptoms of beryllium exposure may be
related to inhalation or dermal exposure. Finally, OSHA modified the
wording of (f)(1)(ii) to require the employer to update "each"
written exposure control plan rather than "the" written exposure
control plan, since an employer who operates multiple facilities is
required to establish, implement and maintain a written exposure
control plan for each facility.
Paragraph (f)(1)(iii) of the proposed rule would have required the
employer to make a copy of the exposure control plan accessible to each
employee who is or can reasonably be expected to be exposed to airborne
beryllium in accordance with OSHA's Access to Employee Exposure and
Medical Records (Records Access) standard (29 CFR 1910.1020(e)). OSHA
did not receive comments specific to this provision, and has retained
it in the final standard for general industry and included the
paragraph in the final standards for construction and shipyards.
Respiratory Protection
Proposed Paragraph (g) of the standard would have established the
requirements for the use of respiratory protection. OSHA added language
to paragraph (g) to clarify that both the selection and use of
respiratory protection must be in accordance with the Respiratory
Protection standard 29 CFR 1910.134, which is cross-referenced, and to
provide a powered air-purifying respirator (PAPR) when requested by an
employee. The Respiratory protection standard contains collection of
information requirements, include a written respiratory protection
program and fit-testing records (29 CFR 1910.134(c)). The collection of
information requirements contained in the Respiratory Protection
Program standard are approved under OMB Control Number 1218-0099.
Personal Protective Equipment
Final paragraph (h)(3)(iii), like proposed paragraph (h)(3),
requires employers to inform in writing the persons or the business
entities who launder, clean or repair the protective clothing or
equipment required by this standard of the potentially harmful effects
of exposure to airborne beryllium and contact with soluble beryllium
compounds and how the protective clothing and equipment must be handled
in accordance with the standard.
Housekeeping
Paragraph (j)(3) requires warning labels in accordance with the
requirements in paragraph (m) when employer transfer materials
containing beryllium. Medical Surveillance Final paragraph (k) sets
forth requirements for the medical surveillance provisions. The
paragraph specifies which employees must be offered medical
surveillance, as well as the frequency and content of medical
examinations. It also sets forth the information that the licensed
physician and CBD diagnostic center is to provide to the employee and
employer.
In paragraphs (k)(1)(i)(A)-(D) of the proposal, OSHA specified that
employers must make medical surveillance required by this paragraph
available for each employee: (1) Who has worked in a regulated area for
more than 30 days in the last 12 months; (2) showing symptoms or signs
of CBD, such as shortness of breath after a short walk or climbing
stairs, persistent dry cough, chest pain, or fatigue; or (3) exposed to
beryllium during an emergency; and (4) who was exposed to airborne
beryllium above .2 μg/m3\ for more than 30 days in a 12-month
period for 5 years or more, limited to the procedures described in
paragraph (k)(3)(ii)(F) of this section unless the employee also
qualifies for an examination under paragraph (k)(1)(i)(A), (B), or (C)
of this section. OSHA revised the first proposed medical surveillance
trigger to require the offering of medical surveillance based on
exposures at or above the action level, rather than the PEL. In
addition, OSHA revised the proposed trigger to require employers to
make medical surveillance available to each employee who is or is
reasonably expected to be exposed at or above the action level for more
than 30 days a year, rather than waiting for the 30th day of exposure
to occur.
Paragraph (k)(1)(i)(B) has been revised to include signs or
symptoms of other beryllium-related health effects.
Proposed paragraph (k)(1)(i)(C) required employers to offer medical
surveillance to employees exposed during an emergency. No revisions
were made to this paragraph.
OSHA added final paragraph (k)(1)(i)(D), which requires that
medical surveillance be made available when the most recent written
medical opinion to the employer recommends continued medical
surveillance. Under final paragraphs (k)(6) and (k)(7), the written
opinion must contain a recommendation for continued periodic medical
surveillance if the employee is confirmed positive or diagnosed with
CBD, and the employee provides written authorization.
Frequency: Proposed paragraph (k)(2) specified when and how
frequently medical examinations were to be offered to those employees
covered by the medical surveillance program. Under proposed paragraph
(k)(2)(i)(A), employers would have been required to provide each
employee with a medical examination within 30 days after making a
determination that the employee had worked in a regulated area for more
than 30 days in the past 12 months, unless the employee had received a
medical examination provided in accordance with this standard within
the previous 12 months. OSHA made several changes to this requirement.
First, OSHA revised the medical surveillance trigger of employees
working in a regulated area to a determination that employee is or is
reasonably expected to be exposed at or above the action level for more
than 30 days of year; or who shows signs or symptoms of CBD or other
beryllium-related health effects. Second, the Agency changed the
extended the length of time from within the last 12 months to within
the last two years.
Proposed paragraph (k)(2)(ii) required employers to provide an
examination annually (after the first examination is made available) to
employees who continue to meet the criteria of proposed paragraph
(k)(1)(i)(A) or (B). OSHA revised the paragraph to specify that medical
examinations were to be made available "at least" every two years and
to include employees who continue to meet the criteria of final
paragraph (k)(1)(i)(D), i.e., each employee whose most recent written
medical opinion required by paragraph (k)(6) or (k)(7) recommends
periodic medical surveillance. Under the final standards, employees
exposed in an
emergency, who are covered by paragraph (k)(1)(i)(C), are not included
in the biennial examination requirement unless they also meet the
criteria of paragraphs (k)(1)(i)(A) or (B) or (D). Final paragraph
(k)(2)(i)(A) also differs from the proposal in that in the proposed
paragraph the employer did not have to offer an examination if the
employee had received an equivalent examination within the last 12
months. In the final rule, this was increased to within two years to
align that provision with the frequency of periodic examinations, which
is every two years in the final rule.
Proposed paragraph (k)(2)(iii) required the employer to offer a
medical examination at the termination of employment, if the departing
employee met any of the criteria of proposed paragraphs (k)(1) at the
termination of employment for each employee who met the criteria of
paragraphs (k)(1)(i)(A), (B), or (C), unless an examination has been
provided in accordance with the standard during the 6 months prior to
the date of termination.
Final paragraph (k)(2)(iii) requires the employer to make a medical
examination available to each employee who meets the criteria of final
paragraph (k)(1)(i) at the termination of employment, unless the
employee received an exam meeting the requirements of the standards
within the last 6 months. OSHA extended the requirement to employees
who meet the criteria of final paragraph (k)(1)(i)(D).
Contents of Examination. Paragraph (k)(3) details the contents of
the examination. Paragraph (k)(3)(i) requires the employer to ensure
that the PLHCP advised the employee of the risks and benefits of
participating in the medical surveillance program and the employee's
right to opt out of any or all parts of the medical examination.
Paragraphs (k)(3)(ii)(A)-(D) detail the content of the medical
examination. The final rule made several changes to the content of the
employee medical examination including, but not limited to, revising
paragraphs: (k)(3)(ii)(A), to include emphasis on past and present
airborne exposure to or dermal contact with beryllium; (k)(3)(ii)(C) to
require a physical examination for skin rashes, rather than an
examination for breaks and wounds; (k)(3)(ii)(E) to require the BeLPT
test to be offered "at least" every two years, rather than every two
years; (k)(3)(ii)(F) to include an LDCT scan when recommended by the
PLHCP. With these changes, final paragraphs (k)(3)(ii)(A)-(D) require
the medical examination to include: (1) Medical and work history, with
emphasis on past and present airborne exposure to or dermal contact
with beryllium, any history of respiratory dysfunction and smoking
history, and; (2) a physical examination with emphasis on the
respiratory system; (3) a physical examination for skin rashes; and (4)
a pulmonary function test, performed in accordance with guidelines
established by the ATS including forced vital capacity (FVC) and a
forced expiratory volume in one second (FEV1). A more detailed
discussion regarding all of the changes to the content of the Medical
examinations may be found in section XVI, Summary and Explanation of
the Standards, under (k) Medical Surveillance.
Information Provided to the PLHCP
Proposed paragraph (k)(4) detailed which information must be
provided to the PHLCP. Specifically, the proposed standard required the
employer to provide to the examining PLHCP the following information,
if known to the employer: A description of the employee's former and
current duties that relate to the employee's occupational exposure
((k)(4)(i)); the employee's former and current levels of occupational
exposure ((k)(4)(ii)); a description of any personal protective
clothing and equipment, including respirators, used by the employee,
including when and for how long the employee has used that clothing and
equipment ((k)(4)(iii)); and information the employer has obtained from
previous medical examinations provided to the employee, that is
currently within the employer's control, if the employee provides a
medical release of the information ((k)(4)(iv)). OSHA made several
changes to this paragraph. First, OSHA updated paragraph (k)(4)(i) to
require the employer to provide a description of the employee's former
and current duties that relate to both the employee's airborne exposure
to and dermal contact with beryllium, instead of merely requiring the
provision of information related to occupational exposure. Second, OSHA
changed the requirement that the employer obtain a "medical release"
from the employee to "written consent" before providing the PLHCP
with information from records of employment-related medical
examinations. Third, OSHA revised the provision to require that the
employer ensure that the same information provided to the PLHCP is also
provided to the agreed-upon CBD diagnostic center, if an evaluation is
required under paragraph (k)(7) of the standard.
Licensed Physician's Written Medical Opinion
Paragraph (k)(5) of the proposed standard provided for the licensed
physician to give a written medical opinion to the employer, but relied
on the employer to give the employee a copy of that opinion; thus,
there was no difference between information the employer and employee
received. The final standards differentiate the types of information
the employer and employee receive by including two separate paragraphs
within the medical surveillance section that require a written medical
report to go to the employee, and a more limited written medical
opinion to go to the employer. The requirement to provide the medical
opinion to the employee is in paragraph (k)(5) of the final standards;
the requirement for providing documentation to the employer is in
paragraph (k)(6) of the final standards. Most significantly, OSHA
removed the requirement that the medical opinion pass through the
employer to the employee.
Licensed Physician's Written Medical Report for the Employee
Final paragraphs (k)(5)(i)-(v) provide the contents of the licensed
physician's written medical report for the employee. They include: The
results of the medical examination, including any medical condition(s),
such as CBD or beryllium sensitization (i.e., the employee is confirmed
positive, as is defined in paragraph (b) of the standard), that may
place the employee at increased risk from further airborne exposure;
any medical conditions related to airborne exposure that require
further evaluation or treatment (this requirement was not expressly
included in the proposal); any recommendations on the employee's use of
respirators, protective clothing, or equipment; and any recommended
limitations on airborne beryllium exposure.
Paragraph (k)(5) also provides that if the employee is confirmed
positive or diagnosed with CBD, or if the physician otherwise deems it
appropriate, the written medical report must also contain a referral to
a CBD diagnostic center, a recommendation for continued medical
surveillance, and a recommendation for medical removal from airborne
beryllium exposures above the action level, as described in paragraph
(l) of the standard. Proposed paragraph (k)(6) also addressed
information provided to employees who were confirmed positive or
diagnosed with CBD, but simply required a consultation with the
physician.
Licensed Physician's Written Medical Opinion for the Employer
Paragraph (k)(6)(i) requires employers to obtain a written medical
opinion from the licensed physician within 45 days of the medical
examination (including any follow-up BeLPT required under
(k)(3)(ii)(E)). In proposed (k)(5), the physician would have been
required to share most of the information identified now provided
directly to the employee per final (k)(5) with the employer, but in the
final rule OSHA limited the information that could be shared with the
employer. In final (k)(6) the written medical opinion for the employer
must contain only the date of the examination, a statement that the
examination has met the requirements of this standard, and any
recommended limitations on the employee's use of respirators,
protective clothing, and equipment; and a statement that the PLHCP
explained the results of the examination to the employee, including any
tests conducted, any medical conditions related to airborne exposure
that require further evaluation or treatment, and any special
provisions for use of personal protective clothing or equipment.
Paragraph (k)(6)(ii) states that if the employee provides written
authorization, the written medical opinion for the employer must also
contain any recommended limitations on the employee's airborne exposure
to beryllium. The requirement for written authorization was not in the
proposal. Paragraphs (k)(6)(iii)-(v) state that if an employee is
confirmed positive or diagnosed with CBD and the employee provides
written authorization, the written opinion must also contain a referral
for evaluation at a CBD diagnostic center and recommendations for
continued medical surveillance and medical removal from airborne
exposure to beryllium as described in paragraph (l).
Paragraph (k)(6)(vi) requires the employer to ensure that employees
receive a copy of the written medical opinion for the employer within
45 days of any medical examination (including any follow-up BeLPT
required under paragraph (k)(3)(ii)(E) of this standard) performed for
that employee. A similar requirement was included in proposed
(k)(5)(iii), but the time period was two weeks.
Beryllium Sensitization Test Results Research (Removed)
Proposed paragraph (k)(7) would have required employers to convey
the results of beryllium sensitization tests to OSHA for evaluation and
analysis at the request of OSHA. Based on comments received during the
comment period, OSHA decided not to include the proposed paragraph
(k)(7) in the final standard.
Referral to a Diagnostic Center
Final paragraph (k)(7) requires that if the employee wants a
clinical evaluation at a CBD diagnostic center, the employer must
provide the examination at no cost to the employee. OSHA made several
changes to final paragraph (k)(7) as compared to similar provisions in
paragraph (k)(6) of the proposal. First, OSHA changed the trigger for
referral to a CBD diagnostic center to include both confirmed positive
and a CBD diagnosis for consistency with final paragraphs (k)(5)(iii)
and (k)(6)(iii). Second, OSHA removed the requirement for a
consultation between the physician and employee. However, final
paragraph (k)(7)(i) requires that employers provide a no-cost
evaluation at a CBD-diagnostic center that is mutually agreed upon by
the employee and employer.
Final paragraph (k)(7) requires the employer to ensure that the
employee receives a written medical report form the CBD diagnostic
center that contains all the information required in paragraph
(k)(5)(i), (ii), (iv) and (v) and that the PLHCP explains the results
of the examination of the employee within 30 days of the examination.
Communication of Hazards
Proposed paragraph (m)(1)(i) required chemical manufacturers,
importers, distributors, and employers to comply with all applicable
requirements of the HCS (29 CFR 1910.1200) for beryllium. No
substantive changes were made to this paragraph.
Proposed paragraph (m)(1)(ii) would have required employers to
address at least the following, in classifying the hazards of
beryllium: Cancer; lung effects (chronic beryllium disease and acute
beryllium disease); beryllium sensitization; skin sensitization; and
skin, eye, and respiratory tract irritation. According to the HCS,
employers must classify hazards if they do not rely on the
classifications of chemical manufacturers, importers, and distributors
(see 29 CFR 1910.1200(d)(1)). OSHA revised the language to bring it
into conformity with other substance specific standards so it is clear
that chemical manufacturers, importers, and distributors are among the
entities required to classify the hazards of beryllium. OSHA has chosen
not to include an equivalent requirement in the final standards for
construction and shipyards since employers in construction and
shipyards are generally downstream users of beryllium products
(blasting media) and would not therefore be classifying chemicals.
Proposed paragraph (m)(1)(iii) would have required employers to
include beryllium in the hazard communication program established to
comply with the HCS, and ensure that each employee has access to labels
on containers and safety data sheets for beryllium and is trained in
accordance with the HCS and the training paragraph of the standard. The
final paragraph (m)(1)(iii) applies to the general industry, shipyards,
and construction. The final provisions are substantively unchanged from
the proposal.
Recordkeeping
Paragraph (n) of the final standards sets forth the employer's
obligation to comply with requirements to maintain records of air
monitoring data, objective data, medical surveillance, and training.
Proposed paragraph (n)(1)(i) required employers to maintain records
of all measurements taken to monitor employee exposure to beryllium as
required by paragraph (d) of the standard. OSHA made one minor
modification in the final standard: OSHA added the words "make and"
prior to "maintain" in order to clarify that the employer's
obligation is to create and preserve such records.
Proposed paragraph (n)(1)(ii) required that records of all
measurements taken to monitor employee exposure include at least the
following information: The date of measurement for each sample taken;
the operation being monitored; the sampling and analytical methods used
and evidence of their accuracy; the number, duration, and results of
samples taken; the type of personal protective clothing and equipment,
including respirators, worn by monitored employees at the time of
monitoring; and the name, social security number, and job
classification of each employee represented by the monitoring,
indicating which employees were actually monitored. OSHA has made one
editorial modification to paragraph (n)(1)(ii)(B), which is to change
"operation" to "task." Proposed paragraph (n)(1)(iii) required
employers to maintain employee exposure monitoring records in
accordance with 29 CFR 1910.1020(d)(1)(ii). OSHA has changed the
requirement that the employer "maintain this record as required by"
OSHA's Records Access standard to "ensure that exposure records are
maintained and made available in accordance with" that standard.
Proposed Paragraph (n)(2) Historical Monitoring Data (Removed)
Proposed paragraph (n)(2) contained the requirement to retain
records of any historical monitoring data used to satisfy the proposed
standard's the initial monitoring requirements. OSHA deleted the
separate recordkeeping requirement for historical data.
Final (n)(2)(i), (ii), and (iii) Objective Data
As a result of deleting paragraph (n)(2) Historical Data, OSHA has
included proposed paragraph (n)(3) as paragraph (n)(2) in the final
standards, with minor alterations. Paragraph (n)(2) contains the
requirements to keep accurate records of objective data. Paragraph
(n)(2)(i) requires employers to establish and maintain accurate records
of the objective data relied upon to satisfy the requirement for
initial monitoring in paragraph (d)(2). Under paragraph (n)(2)(ii), the
record is required to contain at least the following information: (A)
The data relied upon; (B) the beryllium-containing material in
question; (C) source of the data; (D) description of the process, task,
or activity on which the objective data were based; (E) other data
relevant to the process, task, activity, material, or airborne exposure
on which the objective data were based. These requirements included
minor changes in the description of the last two changes, but were not
substantively different.
Paragraph (n)(2)(iii) of the final standard (paragraph (n)(3)(iii)
in the proposal) requires the employer to maintain a record of
objective data relied upon as required by the Records Access standard,
which specifies that exposure records must be maintained for 30 years
(29 CFR 1910.1020(d)(1)(ii)).
Paragraph (n)(3)(i), (ii), & (iii) Medical Surveillance Records
Paragraph (n)(3) of the final standards (paragraph (n)(4) in the
proposal), addresses medical surveillance records. Employers must
establish and maintain medical surveillance records for each employee
covered by the medical surveillance requirements in paragraph (k).
Paragraph (n)(3)(ii) lists the categories of information that an
employer was required to record: The employee's name, social security
number, and job classification; a copy of all licensed physicians'
written medical opinions; and a copy of the information provided to the
PLHCP. OSHA has moved the requirement that the record include copies of
all licensed physicians' written opinions from proposed paragraph
(n)(4)(ii)(B) to paragraph (n)(3)(ii)(B) of the final standards.
Proposed paragraph (n)(4)(iii) required the employer to maintain
employee medical records in accordance with OSHA's Records Access
Standard at 29 CFR 1910.1020. OSHA has added "and made available"
after "maintained" in final paragraph (n)(3)(iii) of the standards,
but the requirement is otherwise unchanged.
Paragraph (n)(4)(i) and (ii) Training Records
Paragraph (n)(4) of the final standards (paragraph (n)(5) of the
proposal) requires employers to preserve training records, including
records of annual retraining or additional training, for a period of
three years after the completion of the training. At the completion of
training, the employer is required to prepare a record that includes
the name, social security number, and job classification of each
employee trained; the date the training was completed; and the topic of
the training. This record maintenance requirement also applied to
records of annual retraining or additional training as described in
paragraph (m)(4). This paragraph is substantively unchanged from the
proposal.
Paragraph (n)(5) Access to Records
Paragraph (n)(5) of the final standards (paragraph (n)(6) of the
proposal), requires employers to make all records mandated by these
standards available for examination and copying to the Assistant
Secretary, the Director of NIOSH, each employee, and each employee's
designated representative as stipulated by OSHA's Records Access
standard (29 CFR 1910.1020). This paragraph is substantively unchanged
from the proposal.
Paragraph (n)(6) Training Records
Paragraph (n)(6) of the final standards (paragraph (n)(6) in the
proposal), requires that employers comply with the Records Access
standard regarding the transfer of records, 29 CFR 1910.1020(h), which
instructs employers either to transfer records to successor employers
or, if there is no successor employer, to inform employees of their
access rights at least three months before the cessation of the
employer's business. This paragraph is substantively unchanged from the
proposal.
X. Federalism
OSHA reviewed the final beryllium rule according to the most recent
Executive Order ("E.O.") on Federalism, E.O. 13132, 64 FR 43255 (Aug.
10, 1999). The E.O. requires that Federal agencies, to the extent
possible, refrain from limiting State policy options, consult with
States before taking actions that would restrict States' policy
options, and take such actions only when clear constitutional authority
exists and the problem is of national scope. The E.O. allows Federal
agencies to preempt State law only with the expressed consent of
Congress. In such cases, Federal agencies must limit preemption of
State law to the extent possible.
Under Section 18 of the Occupational Safety and Health Act (the
"Act" or "OSH Act"), 29 U.S.C. 667, Congress expressly provides
that States may adopt, with Federal approval, a plan for the
development and enforcement of occupational safety and health
standards. OSHA refers to States that obtain Federal approval for such
plans as "State-Plan States." 29 U.S.C. 667. Occupational safety and
health standards developed by State-Plan States must be at least as
effective in providing safe and healthful employment and places of
employment as the Federal standards. Subject to these requirements,
State-Plan States are free to develop and enforce their own
occupational safety and health standards.
While OSHA wrote this final rule to protect employees in every
State, Section 18(c)(2) of the OSH Act permits State-Plan States to
develop and enforce their own standards, provided those standards
require workplaces to be at least as safe and healthful as this final
rule requires. Additionally, standards promulgated under the OSH Act do
not apply to any worker whose employer is a state or local government.
29 U.S.C. 652(5).
This final rule complies with E.O. 13132. In States without OSHA-
approved State plans, Congress expressly provides for OSHA standards to
preempt State occupational safety and health standards in areas
addressed by the Federal standards. In these States, this rule limits
State policy options in the same manner as every standard promulgated
by the Agency. In States with OSHA-approved State plans, this
rulemaking does not significantly limit State policy options to adopt
stricter standards.
XI. State-Plan States
When Federal OSHA promulgates a new standard or a more stringent
amendment to an existing standard, the States and U.S. territories with
their own OSHA-approved occupational safety and health plans ("State-
Plan
States") must revise their standards to reflect the new standard or
amendment. The State standard must be at least as effective as the
Federal standard or amendment, and must be promulgated within six
months of the publication date of the final Federal rule. 29 CFR
1953.5(a). Currently, there are 28 State-Plan States.
A State-Plan State may demonstrate that a standard change is not
necessary because the State standard is already the same as or at least
as effective as the new or amended Federal standard. In order to avoid
delays in worker protection, the effective date of the State standard
and any of its delayed provisions must be the date of State
promulgation or the Federal effective date, whichever is later. The
Assistant Secretary may permit a longer time period if the State makes
a timely demonstration that good cause exists for extending the time
limitation. 29 CFR 1953.5(a).
Of the 28 States and territories with OSHA-approved State plans, 22
cover public and private-sector employees: Alaska, Arizona, California,
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada,
New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina,
Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The
remaining six states and territories cover only public-sector
employees: Connecticut, Illinois, New Jersey, Maine, New York, and the
Virgin Islands.
This beryllium rule applies to general industry, construction, and
shipyards. This rule requires that all State-Plan States revise their
standards appropriately within six months of the date of this notice.
XII. Unfunded Mandates Reform Act
Under Section 202 of the Unfunded Mandates Reform Act of 1995
("UMRA"), 2 U.S.C. 1532, an agency must prepare a written
"qualitative and quantitative assessment" of any regulation creating
a mandate that "may result in the expenditure by the State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation)" in any one
year before promulgating a final rule. OSHA's rule does not place a
mandate on State or local governments, for purposes of the UMRA,
because OSHA cannot enforce its regulations or standards on State or
local governments. 29 U.S.C. 652(5). Under voluntary agreement with
OSHA, some States require public sector entities to comply with State
standards, and these agreements specify that these State standards must
be at least as protective as OSHA standards. The OSH Act does not cover
tribal governments in the performance of traditional governmental
functions, though it does cover tribal governments when they engage in
commercial activity. However, the final rule will not require tribal
governments to expend, in the aggregate, $100,000,000 or more in any
one year for their commercial activities. Thus, the final rule does not
trigger the requirements of UMRA based on its impact on State, local,
or tribal governments.
Based on the analysis presented in the Final Economic Analysis (see
Section VIII above), OSHA concludes that the rule would not impose a
Federal mandate on the private sector in excess of $100 million
(adjusted annually for inflation) in expenditures in any one year. As
noted below, OSHA also reviewed this final rule in accordance with E.O.
13175 on Consultation and Coordination with Indian Tribal Governments,
65 FR 67249 (Nov. 9, 2000), and determined that it does not have
"tribal implications" as defined in that Order.
XIII. Protecting Children From Environmental Health and Safety Risks
E.O. 13045, 66 FR 19931 (Apr. 23, 2003), requires that Federal
agencies submitting covered regulatory actions to OMB's Office of
Information and Regulatory Affairs ("OIRA") for review pursuant to
E.O. 12866, 58 FR 51735 (Oct. 4, 1993), must provide OIRA with (1) an
evaluation of the environmental health or safety effects that the
planned regulation may have on children, and (2) an explanation of why
the planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the agency. E.O. 13045
defines "covered regulatory actions" as rules that may (1) be
economically significant under E.O. 12866 (i.e., a rulemaking that has
an annual effect on the economy of $100 million or more, or would
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities), and (2) concern an environmental health risk or safety
risk that an agency has reason to believe may disproportionately affect
children. In this context, the term "environmental health risks and
safety risks" means risks to health or safety that are attributable to
products or substances that children are likely to come in contact with
or ingest (e.g., through air, food, water, soil, or product use).
The final beryllium rule is economically significant under E.O.
12866 (see Section IX of this preamble). However, after reviewing the
rule, OSHA has determined that it will not impose environmental health
or safety risks to children as set forth in E.O. 13045. The final rule
will require employers to limit employee exposure to beryllium and take
other precautions to protect employees from adverse health effects
associated with exposure to beryllium. OSHA is not aware of any studies
showing that exposure to beryllium in workplaces disproportionately
affects children, who typically are not allowed in workplaces where
such exposure exists. OSHA is also not aware that there are a
significant number of employees under 18 years of age who may be
exposed to beryllium, or that employees of that age are
disproportionately affected by such exposure. One commenter, Kimberly-
Clark Professional, noted that children may be subject to secondary
beryllium exposure due to beryllium particles being carried home on
their parents' work clothing, shoes, and hair (Document ID 1962, p. 2).
Commenter Evan Shoemaker also noted that "beryllium can collect on
surfaces such as shoes, clothing, and hair as well as vehicles leading
to contamination of the family and friends of workers exposed to
beryllium" (Document ID 1658, p. 3). However, OSHA does not believe
beryllium exposure disproportionately affects children or that
beryllium particles brought home on work clothing, shoes, and hair
result in exposures at or near the action level. Furthermore, Kimberly-
Clark Professional also noted that potential secondary exposures can be
controlled through the use of personal protective equipment in the
workplace (Document ID 1676, p. 2). The final standards contain
ancillary provisions, such as personal protective clothing and hygiene
areas, which are specifically designed to minimize the amount of
beryllium leaving the workplace. Therefore, OSHA believes that the
final beryllium rule does not constitute a covered regulatory action as
defined by E.O. 13045.
XIV. Environmental Impacts
OSHA has reviewed the final beryllium rule according to the
National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et
seq.), the regulations of the Council on Environmental Quality (40 CFR
part 1500), and the Department of Labor's NEPA procedures (29 CFR part
11). OSHA made a preliminary determination that the proposed
standard would have no significant impact on air, water, or soil
quality; plant or animal life; the use of land or aspects of the
external environment. No comments to the record questioned this
determination, nor has the Agency found other evidence to invalidate
it. Therefore, OSHA concludes that the final beryllium standard will
have no significant environmental impacts.
XV. Consultation and Coordination With Indian Tribal Governments
OSHA reviewed this final rule in accordance with E.O. 13175 on
Consultation and Coordination with Indian Tribal Governments, 65 FR
67249 (Nov. 9, 2000), and determined that it does not have "tribal
implications" as defined in that order. The OSH Act does not cover
tribal governments in the performance of traditional governmental
functions, so the rule will not have substantial direct effects on one
or more Indian tribes in their sovereign capacity, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes. On the other hand, employees in
commercial businesses owned by tribes or tribal members will receive
the same protections and benefits of the standard as all other covered
employees.
XVI. Summary and Explanation of the Standards
OSHA proposed a standard for occupational exposure to beryllium and
beryllium compounds in general industry and proposed regulatory
alternatives to address beryllium exposures in the construction and
maritime industries. The proposed standard for general industry was
structured according to OSHA's traditional approach, with permissible
exposure limits, and ancillary provisions such as exposure assessment,
methods of compliance, and medical surveillance. As discussed below,
OSHA based the proposal substantively on a joint industry and labor
stakeholders' draft occupational health standard developed and
submitted to OSHA by Materion Corporation (Materion) and the United
Steelworkers (USW). The final rule, however, is based on the entirety
of the rulemaking record.
In the final rule, OSHA is expanding coverage to include the
construction and shipyard industries and establishing separate final
standards for occupational exposure to beryllium in general industry,
construction, and shipyards. In the NPRM, OSHA discussed Regulatory
Alternative 2a to include both the construction and shipyard industries
in the final rule (80 FR 47732-47734), presented estimated costs and
benefits associated with extending the scope of the final rule, and
requested comment on the alternative. The decision to include standards
for construction and shipyards is based on information and comment
submitted in response to this request for comment and evaluated by OSHA
during the public comment periods and the informal public hearing. OSHA
decided to issue three separate standards because there are some
variations in the standards for each industry, although the structure
of the final standards for general industry, construction, and
shipyards remains generally consistent with other OSHA health
standards. The most significant change is in the standard for
construction where paragraph (e) Competent person, replaces paragraph
(e) Beryllium work areas and regulated areas in general industry and
paragraph (e) Regulated areas in shipyards.
All three final standards have a provision for methods of
compliance, although in the standard for construction this provision
has an additional requirement to describe procedures used by the
designated competent person to restrict access to work areas, when
necessary, to minimize the number of employees exposed to airborne
beryllium above the PEL or STEL. This requirement allows the competent
person to perform essentially the same role as the requirement
governing regulated areas in general industry and shipyards, which is
to regulate and minimize the number of workers exposed to hazardous
levels of beryllium. OSHA decided to include a competent person
provision in the final standard for construction because of the
industry's familiarity with this concept and its past successful use in
many OSHA construction standards and documents. "Competent person" is
defined in OSHA's Safety and Health Regulations for Construction (29
CFR 1926.32(f)) as being a person who is capable of identifying
existing and predictable hazards in the surroundings or working
conditions which are unsanitary, hazardous, or dangerous to employees,
and who has authorization to take prompt corrective measures to
eliminate them. This generally applicable definition corresponds well
with the definition for "competent person" in the standard for
construction: In this context, "competent person" means an individual
who is capable of identifying existing and foreseeable beryllium
hazards in the workplace and who has authorization to take prompt
corrective measures to eliminate or minimize them. The competent person
must have the knowledge, ability, and authority necessary to fulfill
the responsibilities set forth in paragraph (e) of this standard.
OSHA has retained, in modified form, the scope exemption from the
proposed standard for materials containing less than 0.1 percent
beryllium by weight in the standard for general industry and included
it in the standards for construction and shipyards. The scope exemption
has been modified in the final standards with the additional
requirement that the employer must have objective data demonstrating
that employee exposure to beryllium will remain below the action level
as an 8-hour TWA under any foreseeable conditions. The 0.1 percent
exemption was generally supported by commenters from general industry
and shipyards; construction employers did not comment. Other
commenters, especially those representing workers or public health
organizations, expressed concern that these materials, in some cases,
could expose workers to hazardous levels of beryllium. As discussed in
more detail in the summary and explanation for Scope and application,
the objective data requirement addresses these concerns and ensures the
protection of workers who experience significant exposures from
materials containing trace amounts of beryllium. Employers who have
objective data showing that employees will not be exposed at or above
the action level under any foreseeable conditions when processing
materials containing less than 0.1 percent beryllium by weight are
exempt from the standard.
OSHA decided to add a performance option in paragraph (d), Exposure
assessment, as an alternative exposure assessment method to the
scheduled monitoring requirements in the proposed rule, based on public
comment received from industry and labor. OSHA believes the performance
option, which encompasses either exposure monitoring or assessments
based on objective data, gives employers flexibility in determining
employee exposure to beryllium based on to their unique workplace
circumstances. OSHA has provided this performance option in recent
health standards such as respirable crystalline silica (29 CFR
1910.1053(d)(2)) and chromium VI (29 CFR 1910.1026(d)(3)).
OSHA also received comments about other provisions in the proposed
standard, and in some cases, OSHA responded with changes from the
proposed rule that were based on the evidence provided in the record.
Any changes made to the provisions in the final standards are described
in detail in their specific summary and explanation sections.
Although details of the final standards for general industry,
construction, and shipyards differ slightly, most of the requirements
are the same or similar in all three standards. Therefore, the summary
and explanation is organized according to the main requirements of the
standards, but includes paragraph references to the standards for
general industry, construction, and shipyards. The summary and
explanation uses the term "standards" or "final standards" when
referring to all three standards. Generally, when the summary and
explanation refers to the term "standards," it is referring to the
final standards. To avoid confusion, the term "final rule" is
sometimes used when making a comparison to or clarifying a change from
the proposed rule.
The proposed rule applied to occupational exposure to beryllium in
all forms, compounds, and mixtures in general industry, except those
articles and materials exempted by proposed paragraphs (a)(2) and
(a)(3) of the proposed standard. The final standards are identical in
their application to occupational exposures to beryllium. In the
summary and explanation sections, OSHA has changed "beryllium and
beryllium compounds" or anything specifying soluble beryllium to just
"beryllium." OSHA intends the term "beryllium" to cover all forms
of beryllium, including compounds and mixtures, both soluble and poorly
soluble, throughout the summary and explanation sections. Other global
changes in the regulatory text include changing "shall" to "must"
to make it clear when a provision is a requirement and adding
"personal" to "protective clothing or equipment" and "protective
clothing and equipment" consistently. OSHA has changed "exposure" to
"airborne exposure" to make it clear when referring to just airborne
exposure, and specifically noting when OSHA intends to cover dermal
contact.
As noted above, OSHA's proposed rule was based, in part, upon a
draft occupational health standard submitted to the Agency by Materion,
the leading producer of beryllium and beryllium products in the United
States, and USW, an international labor union representing workers who
manufacture beryllium alloys and beryllium-containing products in a
number of industries (Document ID 0754). Materion and USW worked
together to craft a model beryllium standard that OSHA could adopt and
that would have support from both labor and industry. They submitted
their joint draft standard to OSHA in February 2012.
Like the proposal, many of the provisions in the final rules are
identical or substantively similar to those contained in Materion and
USW's draft standard. For example, the final rule for general industry
and the Materion/USW draft standard both include an exclusion for
materials containing less than 0.1 percent beryllium; both contain many
similar definitions; both contain a time weighted average (TWA) PEL of
0.2 μg/m3\; both include exposure monitoring provisions, including
provisions for scheduled monitoring, employee notification of results,
methods of sample analysis, and observation of monitoring; both contain
similar requirements for beryllium work areas and regulated areas; both
mandate a written exposure control plan and engineering and work
practice controls that follow OSHA's traditional hierarchy of controls;
and both include similar provisions related to respiratory protection,
protective clothing and equipment, hygiene areas and practices,
housekeeping, medical surveillance, medical removal protection,
training and communication of hazards, recordkeeping, and compliance
dates.
(a) Scope and Application
Separate standards for general industry, construction, and
shipyards. OSHA proposed a standard addressing occupational exposure to
beryllium in general industry and regulatory alternatives to address
exposures in the construction and maritime industries.\37\ The proposal
was modeled on a suggested rule that was crafted by two major
stakeholders in general industry, Materion Corporation (Materion) and
the United Steelworkers (USW) (Document ID 0754). Materion and USW
provided OSHA with data on exposure and control measures and
information on their experiences with handling beryllium in general
industry settings (80 FR 47774). At the time, the information available
to OSHA on beryllium exposures outside of general industry was limited.
Therefore, the Agency preliminarily decided to limit the scope of its
beryllium rule proposal to general industry but propose regulatory
alternatives that would expand the scope of the proposed standard to
also include employers in construction and maritime if it turned out
the record evidence warranted it. Specifically, OSHA requested comment
on Regulatory Alternative #2a, which would expand the scope of the
proposed standard to also include employers in construction and
maritime, and Regulatory Alternative #2b, which would update 29 CFR
1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A
so that the proposed TWA PEL and STEL would apply to all employers and
employees in general industry, shipyards, and construction, including
occupations where beryllium exists only as a trace contaminant. OSHA
also requested stakeholder comment and data on employees in
construction or maritime, or in general industry, not covered in the
scope of the proposed standard, who deal with beryllium only as a trace
contaminant, who may be at significant risk from occupational beryllium
exposures.
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\37\ The proposed rule did not cover agricultural employers
because OSHA had not found any evidence indicating that beryllium is
used or handled in agriculture in a way that might result in
beryllium exposure. OSHA's authority is also restricted in this
area; since 1976, an annual rider in the Agency's Congressional
appropriations bill has limited OSHA's use of funds with respect to
farming operations that employ fewer than ten employees
(Consolidated Appropriations Act, 1976, 94, 90 Stat. 1420, 1421
(1976) (and subsequent appropriations acts)). In the Notice of
Proposed Rulemaking (NPRM), the Agency requested information on
whether employees in the agricultural sector are exposed to
beryllium in any form and, if so, their levels of exposure and what
types of exposure controls are currently in place (80 FR 47565,
47775). OSHA did not receive comment on beryllium and the
agriculture industry or information that would support coverage of
agricultural operations. Therefore, agriculture employers and
operations are not covered by the rule.
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OSHA did not receive any additional exposure data for construction
or shipyards in response to OSHA's request in the NPRM. However, since
the proposal, OSHA reviewed its OIS compliance exposure database and
identified personal exposure sample results on beryllium for abrasive
blasting workers in construction, general industry and maritime, which
can be found broken out by sector in FEA Table IV.68.
The vast majority of stakeholders who submitted comments on this
issue supported extending the scope of the proposed rule to cover
workers in the construction and maritime industries who are exposed to
beryllium (e.g., Document ID 1592; 1625, p. 3; 1655, p. 15; 1658, p. 5;
1664, pp. 1-2; 1670, p. 7; 1671, Attachment 1, p. 5; 1672, p. 1; 1675,
p. 2; 1676, p. 1; 1677, p. 1; 1679, p. 2; 1681, pp. 5, 16; 1683, p. 2;
1684, Attachment 2, p. 3; 1685, p. 2; 1686, p. 2; 1689, p. 6; 1690, p.
2; 1693, p. 3; 1703, p. 2; 1705, p. 1). For example, the National
Council for Occupational Safety and Health (National COSH) urged that
OSHA should ensure greater
protections to beryllium exposed workers by extending the scope of the
proposed standard to workers in the construction and maritime
industries. National COSH explained: "In the proposed preamble, OSHA
recognizes that these workers are exposed to beryllium during abrasive
blasting and clean-up of spent material. The risks that construction
and maritime workers face when exposed to beryllium particulate is the
same as the risk faced at similar exposures by general industry
workers" (Document ID 1690, p. 2). The American Federation of Labor
and Congress of Industrial Organizations (AFL-CIO) agreed, adding that
"[a]vailable data in the construction and maritime sector shows that
there is a significant risk of sensitization and CBD among these
workers" (Document ID 1689, p. 6). Similarly, the American Industrial
Hygiene Association (AIHA) warned that the "[p]otential for exposure,
especially in the construction industry, is very high" (Document ID
1686, p. 2).
OSHA also heard testimony during the public hearing from Dr. Lee
Newman of the American College of Occupational and Environmental
Medicine (ACOEM), Peggy Mroz of National Jewish Health (NJH), Emily
Gardner of Public Citizen, Mary Kathryn Fletcher of AFL-CIO, and Mike
Wright of the USW that supported covering workers in the construction
and maritime industries (Document ID 1756, Tr. 81; 1756, Tr. 97-98;
1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181). Peggy Mroz of NJH
testified that "[b]ased on the data presented, [NJH] support[s]
expanding the scope of the proposed standard to include . . . employers
in construction and maritime" (Document ID 1756, Tr. 98). Emily
Gardner of Public Citizen argued that "the updated standard cannot
leave construction and shipyard workers vulnerable to the devastating
effects of beryllium" (Document ID 1756, Tr. 175). She added that
"Public Citizen urges OSHA to revise the proposed rule to cover these
workers" (Document ID 1756, Tr. 175).
Several commenters specifically supported Regulatory Alternative
#2a. For example, the International Union, United Automobile,
Aerospace, and Agriculture Implement Workers of America (UAW) indicated
its support for this alternative (Document ID 1693, p. 3 (pdf)). UAW
added that Alternative #2a would cover abrasive blasters, pot tenders,
and cleanup staff working in construction and shipyards who have the
potential for airborne beryllium exposure during blasting operations
and during cleanup of spent media (Document ID 1693, p. 3 (pdf)).
Kimberly-Clark Professional (KCP) similarly indicated that it favored
the adoption of this alternative (Document ID 1676, p. 1). KCP
explained that "[h]azardous exposures are equally dangerous to workers
regardless of whether the worker is in a factory or on a construction
site, and the worker protection provided by OSHA regulations should
also be equal" (Document ID 1676, p. 1). In addition, 3M Company also
observed that Regulatory Alternative #2a is a more protective
alternative (Document ID 1625, p. 3 (pdf)).
However, other commenters argued in favor of keeping the proposed
scope unchanged (e.g., Document ID 1583; 1661, Attachment 2, pp. 6-7;
1673, pp. 12-23). Some of these stakeholders contended that adding
construction and maritime was not necessary (e.g., Document ID 1673,
pp. 20-22). For example, Materion opined that "the requirements of [29
CFR] 1910.94 provide sufficient protections for the construction and
maritime industries and accordingly, [Materion and USW] did not include
construction and maritime within [their] assessment of technological
feasibility or the scope of the standard" (Document ID 1661,
Attachment 2, p. 7). Materion added that "it is [its] understanding
that in the absence of a specific maritime standard, OSHA applies
general industry standards to the maritime industries" (Document ID
1661, Attachment 2, p. 7). While this may be the general practice of
the industry, OSHA does not enforce general industry standards where
the shipyard standards apply unless they are specifically cross
referenced in the shipyard standards.
Some of these commenters offered specific concerns with covering
the construction and maritime industries, or with covering abrasive
blasting in general. For instance, Jack Allen, Inc. argued against
extending the proposed rule to cover the use of coal slag in the
sandblasting industry because the industry already has processes and
controls in place to prevent exposures to all dusts during operations
(Document ID 1582). The Abrasive Blasting Manufacturers Alliance (ABMA)
presented a number of arguments against the coverage of abrasive
blasting. ABMA argued that regulating the trace amounts of beryllium in
abrasive blasting will increase the use of silica-based blasting agents
"despite OSHA's longstanding recommendation of substitution for
silica-based materials" (Document ID 1673, p. 14). ABMA added that
scoping in abrasive blasting would increase the amount of coal slag
materials "going to landfills rather than being used for beneficial
purpose" (Document ID 1673, p. 14). ABMA also cited to technological
feasibility issues in sampling and analysis, noted that the proposed
standard was not appropriately tailored to construction and maritime
worksites, and argued that it is not appropriate to regulate abrasive
blasting on a chemical-by-chemical basis (Document ID 1673, pp. 8, 21-
23).
After careful consideration of these comments and those relating to
Regulatory #2b discussed below, OSHA has decided to adopt Regulatory
Alternative #2a to expand the proposal's scope to cover construction
and shipyards. As noted by commenters like the AFL-CIO, record evidence
shows that exposures above the new action level and PEL, primarily from
abrasive blasting operations, occur in both the construction and
shipyard industries (see Chapter IV of the Final Economic Analysis and
Regulatory Flexibility Analysis (FEA)). As discussed in Section V,
Health Effects, and Section VII, Significance of Risk, employees
exposed to airborne beryllium at these levels are at significant risk
of developing adverse health effects, primarily chronic beryllium
disease (CBD) and lung cancer. And under the OSH Act, and specifically
section 6(b)(5), the Agency is required to set health standards which
most adequately assure, to the extent feasible, that no employee will
suffer material impairment of health or functional capacity even if
such employee has regular exposure to the hazard dealt with by such
standards for the period of his working life. Therefore, OSHA finds it
would be inappropriate to exclude construction and shipyard employers
from coverage under this rule.
OSHA disagrees with Materion's assertion that existing standards
render it unnecessary to have this standard cover construction and
shipyard employers whose employees are exposed to beryllium during
abrasive blasting operations. The OSHA Ventilation standard referenced
by Materion (29 CFR 1910.94) applies only to general industry and does
not cover construction and shipyard workers. The OSHA Ventilation
standard in construction (1926.57) and Mechanical paint removers
standard in shipyards (1915.34) provide some general protections for
abrasive blasting workers but do not provide the level of protection
provided by the ancillary provisions contained in the final standards
such as medical surveillance, personal protective clothing and
equipment, and beryllium-specific training.
OSHA also disagreed with Jack Allen, Inc.'s assertion that the
employers conducting abrasive blasting already have sufficient
processes and controls in place to prevent exposures to all dusts
during operations. OSHA's examination of the record identifies data on
beryllium exposure in the abrasive blasting industry showing beryllium
exposure above the action level and TWA PEL when beryllium-containing
slags are used (e,g., Document ID 1166; 1815, Attachment 35; 1880). And
even in abrasive blasting operations where all available controls and
work processes to reduce beryllium exposure are used, additional
ancillary provisions are still as necessary to protect workers from the
harmful effects of exposure to beryllium as in general industry. OSHA
also finds unsubstantiated ABMA's assertion that regulating the trace
amounts of beryllium in abrasive blasting will increase the use of
silica-based blasting agents and result in an increase in the amount of
coal slag materials going to landfills. OSHA has identified several
controls for abrasive blasting in its technological feasibility
analysis (see Chapter IV of the FEA). OSHA also noted that substitution
is not always feasible and employers should be cautious to not
introduce additional hazards when switching to an alternate media. The
Agency is certainly not encouraging employers to increase the use of
silica sand as a blasting media. However, workers using silica-based
blasting materials are protected under a new comprehensive silica
standard (29 CFR 1910.1053, 29 CFR 1926.1153). Employers are in the
best position to determine which blasting material to use and how to
weigh the costs of compliance with the two rules. A 1998 NIOSH-funded
study on substitute materials for silica sand in abrasive blasting
provides comprehensive information on alternative media and can be used
by employers seeking to identify appropriate abrasive blasting media
alternatives (Document ID 1815, Attachment 85-87). In fact, exploring
the use of alternative media for safer abrasive blasting media is
already underway (Document ID 1741, p. 2). OSHA anticipates that the
amount of slag material being deposited in landfills will remain
constant regardless of its use prior to disposal, as the spent slag
material used in abrasive blasting will still need to be disposed of.
OSHA is also not persuaded by ABMA's technological feasibility argument
that regulating trace amounts of beryllium would require testing below
the limit of detection and that it is not technologically feasible to
measure beryllium exposures in abrasive blasting. As explained in
sections 2 and 12 of Chapter IV of the Final Economic Analysis, there
are a number of available sampling and analytical methods that are
capable of detecting beryllium at air concentrations below the action
level of 0.1 μg/m3\, as well as existing exposure data for
beryllium in abrasive blasting operations. And finally, OSHA disagrees
with ABMA's assertion that regulating abrasive blasting on a chemical-
by-chemical basis is inappropriate. The beryllium rule is typical of
OSHA substance-specific health standards that have been promulgated for
the construction and shipyard industries and include abrasive blasting
operations, such as the Lead standard for construction (1926.62) and
the Lead standard for general industry (1910.1025), which applies to
the shipyard industry.
However, OSHA does agree with ABMA's observation that many of the
conditions in the construction and shipyard industries are distinct
from those in general industry, and agrees that the standard as
proposed was not tailored to construction and shipyard worksites. The
Agency has long recognized a distinction between the construction and
general industry sectors and has issued standards specifically
applicable to construction and shipyard work under 29 CFR part 1926 and
29 CFR part 1915, respectively. OSHA's understanding of the differences
between these industries is why OSHA specifically asked stakeholders
with experience and knowledge of the construction or shipyard
industries to opine on whether coverage of those industries is
appropriate and, if so, how the proposal should be revised to best
protect workers in those industries. As discussed throughout the rest
of this Summary and Explanation section, many stakeholders responded to
OSHA's request.
After careful consideration of the record, OSHA finds that the
unique needs of, conditions in, and challenges posed by the
construction and maritime sectors, particularly concerning abrasive
blasting operations at construction sites and shipyards, warrant
different requirements from general industry. Therefore, OSHA is
issuing three separate standards--one for each of these sectors. OSHA
judges that the primary source of beryllium exposure at construction
worksites and in shipyards is from abrasive blasting operations when
using abrasives that contain trace amounts beryllium.
Abrasive blasters and their helpers are exposed to beryllium from
coal slag and other abrasive blasting material like copper slag that
may contain beryllium as a trace contaminant. The most commonly used
abrasives in the construction industry include coal slag and steel
grit, which are used to remove old coatings and etch the surfaces of
outdoor structures, such as bridges, prior to painting (Document ID
1815, Attachment 93, p. 80). Shipyards are large users of mineral slag
abrasives. In a recent survey conducted for the Navy, the use of coal
slag abrasives accounted for 68 percent and copper slag accounted for
20 percent of abrasive media usage as reported by 26 U.S. shipyards and
boatyards (Document ID 0767). The use of coal and copper slag abrasives
has increased in recent years as industries have sought substitutes for
silica sand blasting abrasives to avoid health risks associated with
respirable crystalline silica (Document ID 1671, Attachment 3; 1681,
Attachment 1, pp. 1-2).
OSHA's exposure profile for abrasive blasters, pot tenders/helpers,
and abrasive material cleanup workers is found in Section 12 of Chapter
IV in the FEA. The exposure profile for abrasive blasters shows a
median of 0.2 μg/m3\, a mean of 2.18 μg/m3\, and a range from
0.004 μg/m3\ to 66.5 μg/m3\. The mean level of 2.18 µg/
m3\ is above the preceding PEL for beryllium. For pot tenders/helpers,
the exposure profile shows a median of 0.09 μg/m3\, a mean of 0.10
μg/m3\, and a range from 0.04 to 0.20 μg/m3\. Beryllium
exposure for workers engaged in abrasive material cleanup shows a
median of 0.18 μg/m3\, a mean of 1.76 μg/m3\, and a range from
0.04 μg/m3\ to 7.4 μg/m3\ (see Section 12 of Chapter IV in the
FEA). OSHA concludes that abrasive blasters, pot tenders/helpers, and
cleanup workers have the potential for significant airborne beryllium
exposure during abrasive blasting operations and during cleanup of
spent abrasive material. Accordingly, these workers require protection
under the beryllium standards. To address high concentrations of
various hazardous chemicals in abrasive blasting, employers are already
required to use engineering and work practice controls to limit
workers' exposures and supplement these controls with respiratory
protection when necessary. For example, abrasive blasters in the
construction industry fall under the protection of the Ventilation
standard (29 CFR 1926.57). The Ventilation standard includes an
abrasive blasting subsection (29 CFR 1926.57(f)), which requires that
abrasive blasting respirators be worn by all abrasive
blasting operators when working inside blast-cleaning rooms (29 CFR
1926.57(f)(5)(ii)(A)), when using silica sand in manual blasting
operations where the nozzle and blast are not physically separated from
the operator in an exhaust-ventilated enclosure (29 CFR
1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures
to hazardous substances in excess of the limits set in Sec. 1926.55
(29 CFR 1926.57(f)(5)(ii)(C)). For the shipyard industry, paragraph (c)
of the Mechanical paint removers standard (29 CFR 1915.34) also has
respiratory protection requirements for abrasive blasting operations.
Because of these requirements, OSHA believes that employers already
have those controls in place and provide respiratory protection during
abrasive blasting operations. Nonetheless, the construction and
shipyard standards' new ancillary provisions such as medical
surveillance, personal protective clothing and equipment, housekeeping,
and beryllium-specific training will provide increased protections to
workers in these industries.
OSHA also received comment and heard testimony on potential
beryllium exposure from other sources. NIOSH commented that
construction workers may be exposed to beryllium when demolishing
buildings or building equipment, based on a study of workers
demolishing oil-fired boilers (Document ID 1671, Attachment 1, pp. 5,
15; 1671, Attachment 21). Peggy Mroz of NJH testified that "[n]umerous
studies have documented beryllium exposure sensitization and chronic
beryllium disease in construction industries, demolition and
decommissioning, and among workers who use non-sparking tools"
(Document ID 1756, Tr. 98). Many such cases were discovered among trade
workers at Department of Energy sites from the National Supplemental
Screening Program (Document ID 1756, Tr. 81-82). Ashlee Fitch from the
USW testified that in addition to abrasive blasting using beryllium-
contaminated slags, workers in the maritime industry use non-sparking
tools that are composed of beryllium alloys. Ms. Fitch stated that
these tools can create beryllium particulate when they are dressed
(e.g., sharpening, grinding, straightening). She also noted that
shipyards may use beryllium for other tasks in the future. Ms. Fitch
alluded to a 2000 Navy survey of potential exposure to beryllium in
shipyards which identified potential beryllium sources in welding,
abrasive blasting, and metal machining (Document ID 1756, Tr. 242-243).
Mr. Wright of the USW testified that shipyard management told a USW
representative "that most of the beryllium that they're aware of comes
in in the form of articles . . . . That is to say, it might be part of
some assembly . . . [a]nd it comes in and it's sealed and closed"
(Document ID 1756, Tr. 270). However, Mr. Wright stated that beryllium
is a high-tech material and that "there is nothing more high-tech than
an aircraft carrier or a nuclear submarine" so exposure from
beryllium-containing alloys cannot be ruled out in these operations
(Document ID 1756, Tr. 270).
Despite requesting information both in the NPRM and during the
public hearing, OSHA does not have sufficient data on beryllium
exposures in the construction and shipyard industries to characterize
exposures of workers in application groups other than abrasive blasting
with beryllium-containing slags. OSHA could not develop exposure
profiles for construction and shipyard workers engaged in activities
involving non-sparking tools, demolition of beryllium-contaminated
buildings or equipment, and working with beryllium-containing alloys.
However, OSHA acknowledges the USW's concerns about future beryllium
use and recognizes that there is potential for exposure to beryllium in
construction and shipyard operations other than abrasive blasting. As
such, workers engaged in such operations are exposed to the same hazard
of developing CBD and other beryllium-related disease, and therefore
deserve the same level of protection as do workers who are engaged in
abrasive blasting or covered in the general industry final rule.
Therefore, although at this time OSHA cannot specifically quantify
exposures in construction or shipyard operations outside of abrasive
blasting, OSHA has determined that it is necessary for the final
standards for construction and maritime to cover all occupational
exposures to beryllium in those industries in order to ensure that the
standard is broadly effective and addresses all potential harmful
exposures.
Three commenters representing the maritime industry supported
Regulatory Alternative #2b--adopting the new PELs for construction and
maritime by updating the existing Z tables to incorporate them, but not
applying the other ancillary provisions of this standard to
construction and maritime (Document ID 1595, p. 2; 1618, p. 2; 1657. p.
1). The Shipbuilders Council of America (SCA) supported lowering the
PEL for beryllium from 2.0 μ/m3\ to 0.2 μ/m3\ in 29 CFR
1915.1000 Table Z, but argued that a new beryllium standard would prove
to be redundant. SCA contended that many shipyards maintain a
comprehensive industrial hygiene program focused on exposure
assessments and protective measures for a variety of metals in shipyard
tasks, and that shipyards encounter beryllium only at trace contaminant
levels in materials involved in the welding and abrasive blasting
processes. SCA stated that the potential hazards inherent in and unique
to abrasive blasting in shipyards are already effectively controlled
through existing regulations (Document ID 1618, pp. 2-4). General
Dynamics' Bath Iron Works expressed similar views in their comments on
this issue, as did Newport News Shipbuilding (Document 1595, p. 2;
1657, p. 1).
In addition to the commenters representing the maritime industry,
Ameren, an electric and natural gas public utility, also supported
applying the proposed TWA PEL and STEL to all employers in general
industry, construction, and maritime even where beryllium exists only
as a trace contaminant (Document ID 1675, p. 3). However, not all
commenters endorsed Alternative #2b. The Department of Energy's
National Supplemental Screening Program (NSSP) did not support this
alternative because the other provisions of the standard would only
cover employers and employees within the scope of the proposed general
industry rule (Document ID 1677, p. 2). Furthermore, many commenters
supported extending the full protections of the standard to the
construction and maritime industries as set forth in Regulatory
Alternative #2a, discussed earlier, which implicitly rejects Regulatory
Alternative #2b (see, e.g., Document ID 1756, Tr. 81; 1756, Tr. 97-98;
1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181).
OSHA is not persuaded by the maritime industry commenters'
assertions that the ancillary provisions of the beryllium standard
would be redundant. While OSHA acknowledges that shipyards encounter
beryllium only at trace levels in materials involved in the welding and
abrasive blasting processes, OSHA disagrees with their contention that
updating the PEL and STEL will provide adequate protection to shipyard
workers. OSHA agrees with NSSP and all the commenters supporting
Regulatory Alternative #2a that a comprehensive standard specific to
beryllium will provide the important protection of ancillary
provisions, such as medical surveillance and medical removal
protection. OSHA intends to
ensure that workers exposed to beryllium in the construction and
shipyard industries are provided with protection that is comparable to
the protection afforded workers in general industry. Therefore, OSHA
has set an identical PEL and STEL and, where no meaningful distinctions
are identified in the record, included substantially the same or
approximately equivalent ancillary provisions in all three standards.
For further discussion of the differences among the standards, see the
provision-specific sections included in this Summary and Explanation.
Therefore, OSHA declines to adopt Regulatory Alternative #2b,
which, as noted above, would have updated 29 CFR 1910.1000 Tables Z-1
and Z-2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A so
that the new TWA PEL and STEL, but not the standard's ancillary
provisions, would apply to all employers and employees in general
industry, shipyards, and construction, including occupations where
beryllium exists only as a trace contaminant. The Agency intends for
employers that are exempt from the scope of these comprehensive
standards in accordance with paragraph (a) to comply with the preceding
TWA PEL and STEL in 29 CFR 1910.1000 Table Z-2, 29 CFR 1915.1000 Table
Z, and 29 CFR 1926.55 Appendix A, as applicable. Given that the Agency
is issuing separate beryllium standards for the construction and
shipyard industries, OSHA is also adding to these tables a cross-
reference to the new standards and clarifying that if the new standards
are stayed or otherwise not in effect, the preceding PEL and short-term
ceiling limit apply.
Paragraph (a)(1). Proposed paragraph (a)(1) applied the standard to
occupational exposures to beryllium in all forms, compounds, and
mixtures in general industry, except those articles and materials
exempted by paragraphs (a)(2) and (a)(3) of the standards. As OSHA
explained in the proposal, the Agency preliminarily chose to treat
beryllium generally, instead of individually addressing specific
compounds, forms, and mixtures. This decision was based on the Agency's
preliminary determination that the toxicological effects of beryllium
exposure on the human body are similar regardless of the form of
beryllium (80 FR 47774).
Several commenters offered opinions on this approach. The Non-
Ferrous Founders' Society (NFFS) expressed concern that beryllium metal
was being treated the same as soluble beryllium compounds, such as
salts, even though NFFS believes these soluble compounds are more
hazardous and suggested that OSHA establish a bifurcated standard for
insoluble beryllium versus soluble beryllium compounds (Document ID
1732, p. 3; 1678, p. 2; 1756, Tr. 18). In related testimony, NIOSH's
Dr. Aleks Stefaniak discussed the dermal exposure mechanisms of poorly
soluble beryllium through particle penetration and particle dissolving
(Document ID 1755, pp. 35-39). Dr. Stefaniak testified that while
"intact skin naturally has a barrier . . . [v]ery few people actually
have fully intact skin, especially in an industrial environment"
(Document ID 1755, p. 36). He added:
in fact, beryllium particles, beryllium oxide, beryllium metal,
beryllium alloys, all these sort of what we call insoluble forms
actually do in fact dissolve very readily in analog of human sweat.
And once beryllium is in an ionic form on the skin, it's actually
very easy for it to cross the skin barrier (Document ID 1755, pp.
36-37).
NIOSH also provided additional information on beryllium solubility and
the development of CBD in its post-hearing brief, labeling as untrue
NFFS's assertion that insoluble beryllium does not cause CBD (Document
ID 1960, Attachment 2, pp. 8-10), citing studies showing that workers
exposed to insoluble forms of beryllium have developed sensitization
and CBD (Kreiss, et al., 1997, Document ID 1360; Schuler et al., 2005
(1349); Schuler et al., 2008 (1291); Wegner et al., 2000, (1960,
Attachment 7)).
After careful consideration of the various comments on this issue,
OSHA is not persuaded that there are differences in workers' health
risks that justify treating poorly soluble beryllium differently than
soluble compounds. The Agency is persuaded by NIOSH that poorly soluble
beryllium presents a significant risk of beryllium-related disease to
workers and discusses this topic further in Section V of this preamble,
Health Effects. OSHA has determined that the toxicological effects of
beryllium exposure on the human body are similar regardless of the form
of beryllium. Therefore, the Agency concludes that the record supports
issuing standards that apply to beryllium in all forms, compounds, and
mixtures. Final paragraph (a)(1) is therefore substantively unchanged
from the proposal in all three standards.
Paragraph (a)(2). Proposed paragraph (a)(2) excluded from the
standard's scope articles, as defined in the Hazard Communication
standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that
the employer does not process. As OSHA explained in the proposal (80 FR
47775), the HCS defines an "article" as
a manufactured item other than a fluid or particle: (i) Which is
formed to a specific shape or design during manufacture; (ii) which
has end use function(s) dependent in whole or in part upon its shape
or design during end use; and (iii) which under normal conditions of
use does not release more than very small quantities, e.g., minute
or trace amounts of a hazardous chemical . . ., and does not pose a
physical hazard or health risk to employees.
OSHA preliminarily found that items or parts containing beryllium that
employers assemble where the physical integrity of the item is not
compromised are unlikely to release beryllium that would pose a
physical or health hazard for workers. Therefore, OSHA proposed to
exempt such articles from the scope of the standard. This proposed
provision was intended to ease the burden on employers by exempting
items from coverage where they are unlikely to pose a risk to
employees.
Commenters generally supported this proposed exemption. For
example, NFFS stated that the exemption was "important and practical"
(Document ID 1678, p. 2; Document ID 1756, Tr. 35-36)). However, two
commenters requested minor amendments to the exemption. First, ORCHSE
Strategies (ORCHSE) asked OSHA to "clarify" that proposed paragraph
(a)(2) "exempts `articles' even if they are processed, unless the
processing releases beryllium to an extent that negates the definition
of an `article' " (Document ID 1691, Attachment 1, p. 16). ORCHSE
asserted that the standard should not apply in a workplace when "the
item actually meets OSHA's definition of an article" and that OSHA
should change the regulation's language accordingly (Document ID 1691,
Attachment 1, pp. 16-17). Second, the American Dental Association (ADA)
asked that OSHA clarify the article exemption, specifically that
employers who use but do not process articles are fully exempt from all
requirements of the proposed rule, including those established for
recordkeeping (Document ID 1597, p. 1).
In contrast, Public Citizen objected to the inclusion of this
exemption because exempting articles that are not processed does not
take into consideration dermal exposure from handling articles
containing beryllium (Document ID 1670, p. 7). Public Citizen pointed
to OSHA's proposed rule in which OSHA acknowledged that beryllium
absorbed through the skin can induce a sensitization response that is a
necessary first step toward CBD and that there is evidence that the
risk is not limited to soluble forms. However, during follow-up
questioning at the beryllium public hearings, Dr. Almashat
of Public Citizen was unable to provide any examples of dermal exposure
from articles through their handling, as opposed to when processing
beryllium materials (Document ID 1756, Tr. 178-180). And, in its post-
hearing comments, Public Citizen did not provide evidence of dermal
exposure to workers handling beryllium materials that would fall under
the definition of article (Document ID 1964). In the final standard,
OSHA has decided not to alter the proposed exemption of articles. OSHA
is not persuaded by ORCHSE's argument that OSHA should change the
regulation's language to exempt articles even if they are processed,
unless the processing releases beryllium to an extent that negates the
definition of an article. The HCS defines an article as
a manufactured item other than a fluid or particle: (i) Which is
formed to a specific shape or design during manufacture; (ii) which
has end use function(s) dependent in whole or in part upon its shape
or design during end use; and (iii) which under normal conditions of
use does not release more than very small quantities, e.g., minute
or trace amounts of a hazardous chemical (as determined under
paragraph (d) of this section), and does not pose a physical hazard
or health risk to employees. (29 CFR 1910.1200(c)).
Whether a particular item is an "article" under the HCS depends on
the physical properties and intended use of that item. However,
employers may use and process beryllium-containing items in ways not
necessarily intended by the manufacturer. Therefore, OSHA has decided
not to link the processing limitation to the definition of an
"article" and is retaining the language of proposed (a)(2) to comport
with the intention of the exemption.
In response to the ADA's request for clarification that employers
who use but do not process articles are fully exempt from all
requirements of the rule, OSHA notes that paragraph (a)(2) of the final
standards states that the "standard does not apply" to those
articles. Furthermore, the recordkeeping requirement for objective data
in paragraph (n)(2) of the standards states that it applies to
objective data used to satisfy exposure assessment requirements, but
does not mention any data used to determine coverage under paragraph
(a). Therefore, OSHA has determined that no further clarification in
the regulatory text is necessary.
In response to the comment from Public Citizen, OSHA did not
receive any evidence on the issue of beryllium exposure through dermal
contact with unprocessed articles. Therefore, OSHA cannot find that
such contact poses a risk.
Paragraph (a)(2) of the final standards therefore remains unchanged
from the proposed standard. The final standards do not apply to
articles, as defined in the Hazard Communication standard (HCS) (29 CFR
1910.1200(c)), that contain beryllium and that the employer does not
process.
Paragraph (a)(3). Proposed paragraph (a)(3) exempted from coverage
materials containing less than 0.1 percent beryllium by weight.
Requesting comment on this exemption (80 FR 47776), OSHA presented
Regulatory Alternative #1a, which would have eliminated the proposal's
exemption for materials containing less than 0.1 percent beryllium by
weight, and #1b, which would have exempted operations where the
employer can show that employees' exposures will not meet or exceed the
action level or exceed the STEL. The Agency asked whether it is
appropriate to include an exemption for operations where beryllium
exists only as a trace contaminant, but some workers can nevertheless
be significantly exposed. And the Agency asked whether it should
consider dropping the exemption, or limiting it to operations where
exposures are below the proposed action level and STEL. In addition,
OSHA requested additional data describing the levels of airborne
beryllium in workplaces that fall under this exemption. Some
stakeholders supported keeping the 0.1 percent exemption as proposed
(Document ID 1661, p. 6; 1666, p. 2; 1668, p. 2; 1673, p. 8; 1674, p.
3; 1687, Attachment 2, p. 8; 1691, Attachment 1, p. 3; 1756, Tr. 35-36,
63). For example, the Edison Electric Institute (EEI) strongly
supported the exemption and asserted "that abandoning the exemption
would result in no additional benefits from a reduction in the
beryllium permissible exposure limit (PEL) or from ancillary provisions
similar to those already in place for the arsenic and other standards"
(Document ID 1674, p. 3). Mr. Weaver of NFFS also opposed eliminating
the exemption, testifying that without the 0.1 percent exemption, 900
to 1,100 foundries would come under the scope of the rule (Document ID
1756, Tr. 55-56).
ABMA also supported the proposed 0.1 percent exemption, suggesting
that there is a lack of evidence of significant risk from working with
material containing beryllium in trace amounts and that OSHA needs
substantial evidence that it is "at least more likely than not" that
exposure to beryllium in trace amounts presents significant risk of
harm, under court decisions concerning the Benzene rule (Document ID
1673, pp. 8-9). ABMA further argued that significant risk does not
exist even below the previous PEL of 2.0 μg/m3\ (Document ID 1673,
pp. 8-9, 11). ABMA added that its members collectively have over 200
years of experience producing coal and/or copper slag abrasive material
and have employed thousands of employees in this production process.
ABMA explained:
Through the years, Alliance members have worked with and put to
beneficial use over 100 million tons of slag material that would
otherwise have been landfilled. Despite this extensive history, the
Alliance members have no history of employees with beryllium
sensitization or beryllium-related illnesses. Indeed, the Alliance
members are not aware of a single documented case of beryllium
sensitization or beryllium-related illness associated with coal or
copper slag abrasive production among their employees, or their
customers' employees working with the products of Alliance members
(Document ID 1673, p. 9).
OSHA is not persuaded by these arguments. The lack of anecdotal
evidence of sensitization or beryllium-related illness does not mean
these workers are not at risk. As noted by Representative Robert C.
"Bobby" Scott, Ranking Member of the U.S. House of Representatives
Committee on Education and the Workforce the U.S. House of
Representatives, "medical surveillance has not been required for
beryllium-exposed workers outside of the U.S. Department of Energy. The
absence of evidence is not evidence of absence" (Document ID 1672). As
discussed in Section II of this preamble, Pertinent Legal Authority,
courts have not required OSHA "to support its finding that a
significant risk exists with anything approaching scientific
certainty" (Benzene, 448 U.S. 607, 656 (1980)). Rather, OSHA may rely
on "a body of reputable scientific thought" to which "conservative
assumptions in interpreting the data . . ." may be applied, "risking
error on the side of overprotection" (Benzene, 448 U.S. at 656). OSHA
may thus act with a "pronounced bias towards worker safety" in making
its risk determinations (Bldg & Constr. Trades Dep't v. Brock, 838 F.2d
1258, 1266 (D.C. Cir. 1988). Where, as here, the Agency has evidence
indicating that a certain operation can result in exposure levels that
the Agency knows can pose a significant risk--such as evidence that
workers that have been exposed to beryllium at the final PEL of 0.2
μg/m3\ in primary beryllium production and beryllium machining
operations have developed CBD (see this preamble at section V, Risk
assessment)--OSHA need not wait until it has specific evidence that
employees in that
particular industry are suffering. A number of commenters supported
Regulatory Alternative #1a, proposing to eliminate the proposal's
exemption for materials containing less than 0.1 percent beryllium by
weight (Document ID 1655, p. 15; 1664, p. 2; 1670, p. 7; 1671,
Attachment 1, p. 5; 1672, pp. 4-5; 1683, p. 2; 1686, p. 2; 1689, pp. 6-
7; 1690, p. 3; 1693, p. 3; 1720, pp. 1, 4). Public Citizen expressed
concern with the proposed exemption and pointed out that OSHA
identified studies in its proposal unequivocally demonstrating that
beryllium sensitization and CBD occur in multiple industries utilizing
products containing trace amounts of beryllium and that such an
exemption would expose workers in such industries to the risks of
beryllium toxicity (Document ID 1670, p. 7). The American Association
for Justice, the AFL-CIO, and the UAW were all concerned that the
proposed standard's 0.1 percent exemption would result in workers being
exposed to significant amounts of beryllium from abrasive blasting
(Document ID 1683, p. 2; 1689, pp. 6-7, 10-11; 1693, p. 3). Both Dr.
Sammy Almashat and Emily Gardner of Public Citizen testified that they
support inclusion of work processes that involve materials containing
less than 0.1 percent of beryllium because the beryllium can become
concentrated in air, even when using materials with only trace amounts
(Document ID 1756, Tr. 174, 177-178, 185-186). Similarly, the AFL-CIO
stated that "there are known over-exposures among industries that use
materials with less than 0.1% beryllium by weight, including an
estimated 1,665 workers in primary aluminum production and 14,859 coal-
fired electric power generation workers" (Document ID 1689, p. 7).
Mary Kathryn Fletcher of the AFL-CIO further explained that the AFL-CIO
supported eliminating the exemption because these employees are at
significant risk for developing sensitization, chronic beryllium
disease (CBD), and lung cancer (Document ID 1756, Tr. 198-199). The
Sampling and Analysis Subcommittee Task Group of the Beryllium Health
and Safety Committee (BHSC Task Group) recommended that OSHA remove the
exemption (Document ID 1655, p. 15). AIHA also recommended eliminating
or reducing the percentage content exemption until data is available to
demonstrate that materials with very low beryllium content will not
result in potential exposure above the proposed PEL (Document ID 1686,
p. 2).
Both NIOSH and North America's Building Trades Unions (NABTU)
expressed concern that the 0.1 percent exemption would expose
construction and shipyard workers conducting abrasive blasting with
coal slags to beryllium in concentrations above the final PEL. NIOSH
and NABTU cited a study by the Center for Construction Research and
Training, and NIOSH also cited one of its exposure assessment studies
of a coal slag blaster showing beryllium air concentrations exceeding
the preceding OSHA PEL (Document ID 1671, Attachment 1, p. 5; 1679, pp.
3-4). In addition, NIOSH points out that although the abrasive blasting
workers may use personal protective equipment that limits exposure,
supervisors and other bystanders may be exposed. NIOSH gave other
examples where the 0.1 percent exemption could result in workers being
exposed to beryllium, such as building or building equipment demolition
and work in dental offices that fabricate or modify beryllium-
containing dental alloys, but did not provide reference material or
exposure data for these examples (Document ID 1671, pp. 5-6). In its
post-hearing brief, NIOSH also specifically disagreed with EEI's
contention that compliance with the arsenic and asbestos standards
satisfies the proposed regulatory requirements of the beryllium rule.
NIOSH argued that, unlike arsenic and lead, beryllium is a sensitizer,
and as such, necessary and sufficient controls are required to protect
workers from life-long risk of beryllium sensitization and disease
(Document ID 1960, Attachment 2, p. 6).
OSHA also received comment and heard testimony from Dr. Weissman of
NIOSH recommending that the scope of the standard be based on employee
exposures and not the concentration of beryllium in the material
(Document ID 1671, pp. 5-6; Document ID 1755, Tr. 17-18). NIOSH
identified coal-fired electric power generation and primary aluminum
production as industries that could fall under the 0.1 percent
exemption (Document ID 1671, Attachment 1, p. 6). Stating it was not
aware of any medical screening of utility workers exposed to fly ash,
NIOSH recommended that OSHA include coal-fired electric power
generation in the scope of the standard unless and until available data
can demonstrate that there is no risk of sensitization to those workers
(Document ID 1671, p. 6). NIOSH did not offer specifics on the
magnitude of beryllium exposure in the aluminum production industry. In
its post-hearing brief, NIOSH recommended that OSHA remove the 0.1
percent exemption from the rule, allowing the rule to cover a broad
range of construction, shipyard, and electric utility power generation
activities that are associated with beryllium exposure, such as
abrasive blasting with coal or copper slag, repairing and maintaining
structures contaminated with fly ash, and remediation or demolition
(Document ID 1960, Attachment 2, p. 2). And Peggy Mroz of NJH testified
that beryllium sensitization and CBD have been reported in the aluminum
industry and that NJH has continued to see cases of severe CBD in
workers exposed to beryllium through medical recycling and metal
reclamation (Document ID 1756, Tr. 98-99).
Other commenters suggested limiting the exemption, as OSHA proposed
in Regulatory Alternative #1b, to require employers to demonstrate,
using objective data, that the materials, when processed or handled,
cannot release beryllium in concentrations at or above the action level
as an 8-hour TWA under any foreseeable conditions (Document ID 1597, p.
1; 1681, pp. 5-6). For example, the Materion-USW proposed standard
included the 0.1 percent exemption unless objective data or initial
monitoring showed exposures could exceed the action level or STEL. USW
asserted that not including this requirement in the rule would be a
mistake (Document ID 1681, pp. 5-6). The AFL-CIO also supported the
joint USW-Materion scope provision (Document ID 1756, Tr. 212). Mike
Wright of the USW asserted that maintaining the 0.1 percent exemption
would leave thousands of workers unprotected, including those
performing abrasive blasting operations in general industry, ship
building, and construction (Document ID 1755, Tr. 111-114). Mr. Wright
argued that in the 1,3 Butadiene standard OSHA recognized that the 0.1
percent exemption would not protect some workers and therefore included
additional language limiting the exemption where objective data showed
"that airborne concentrations generated by such mixtures can exceed
the action level or STEL under reasonably predictable conditions of
processing, use or handling that will cause the greatest possible
release" (Document ID 1755, Tr. 113; 29 CFR 1910.1051(a)(2)(ii)). Mr.
Wright urged OSHA to include similar language in the beryllium standard
(Document ID 1755, Tr. 113-114).
Some commenters endorsed a modified version of Alternative #1b. For
example, the Department of Defense (DOD) supported Alternative #1b, but
also suggested limiting the exemption if exposures "could present a
health risk
to employees" (Document ID 1684, Attachment 2, pp. 1, 3). Boeing
suggested adding a different exemption to the scope of the standard:
where the employer has objective data demonstrating that a material
containing beryllium or a specific process, operation, or activity
involving beryllium cannot release dusts, fumes, or mists of
beryllium in concentrations at or above 0.02 μg/m3\ as an 8-hour
time-weighted average (TWA) or at or above 0.2 μg/m3\ as
determined over a sampling period of 15 minutes under any expected
conditions of use (Document ID 1667, p. 12).
Other commenters, like ABMA, criticized Regulatory Alternative #1b,
insisting that the rulemaking record contained no evidence to support
expanding the scope, but that if the scope was expanded to cover trace
beryllium, a significant exemption would be needed. ABMA argued that
such an exemption would need to go considerably beyond that of using
the action level or STEL because of the substantial costs, particularly
on small businesses, that would be incurred where there is no evidence
of benefit. However, ABMA did not specify what such an exemption would
look like (Document ID 1673, p. 11). Similarly, the National Rural
Electric Cooperative Association (NRECA) objected to Regulatory
Alternative #1b as being unnecessary to protect employees from CBD in
coal fired power plants (Document ID 1687, p. 2).
Ameren did not agree with the objective data requirement in
Regulatory Alternative #1b because it would be difficult to perform
sampling in a timely manner for the many different maintenance
operations that occur infrequently. This would include in the scope of
the rule activities for which exposures are difficult to measure, but
are less likely to cause exposure than other operations (Document ID
1675, p. 2). The NSSP also does not support Regulatory Alternative #1b
because without first expanding the scope of the rule to cover the
construction and maritime sectors, employers in construction and
maritime would still be excluded (Document ID 1677, p. 1).
OSHA agrees with the many commenters and testimony expressing
concern that materials containing trace amounts of beryllium (less than
0.1 percent by weight) can result in hazardous exposures to beryllium.
We disagree, however, with those who supported completely eliminating
the exemption because this could have unintended consequences of
expanding the scope to cover minute amounts of naturally occurring
beryllium (Ex 1756 Tr. 55). Instead, we believe that alternative #1b--
essentially as proposed by Materion and USW and acknowledging that
workers can have significant beryllium exposures even with materials
containing less than 0.1%--is the most appropriate approach. Therefore,
in the final standard, it is exempting from the standard's application
materials containing less than 0.1% beryllium by weight only where the
employer has objective data demonstrating that employee exposure to
beryllium will remain below the action level as an 8-hour TWA under any
foreseeable conditions.
As noted by NIOSH, NABTU, and the AFL-CIO, and discussed in Chapter
IV of the FEA, workers in abrasive blasting operations using materials
that contain less than 0.1 percent beryllium still have the potential
for significant airborne beryllium exposure during abrasive blasting
operations and during cleanup of spent abrasive material. NIOSH and the
AFL-CIO also identified coal-fired electric power generation and
primary aluminum production as industries that could fall under the 0.1
percent exemption but still have significant worker exposure to
beryllium. Furthermore, OSHA agrees with NIOSH that the Agency should
regulate based on the potential for employee exposures and not the
concentration of beryllium in the material being handled. However, OSHA
acknowledges the concerns expressed by ABMA and EEI that processing
materials with trace amounts of beryllium may not necessarily cause
significant exposures to beryllium. OSHA does not have evidence that
all materials containing less than 0.1 percent beryllium by weight can
result in significant exposure to beryllium, but the record contains
ample evidence that there are significant exposures in operations using
materials with trace amounts of beryllium, such as abrasive blasting,
coal-fired power generation, and primary aluminum production. As
discussed in Section VII of this preamble, Significance of Risk,
preventing airborne exposures at or above the action level reduces the
risk of beryllium-related health effects to workers. OSHA is also not
persuaded by comments that claim obtaining this exposure data is too
difficult for infrequent or short-term tasks because employers must be
able to establish their eligibility for the exemption before being able
to take advantage of it. If an employer cannot establish by objective
data, including actual monitoring data, that exposures will not exceed
the action level, then the beryllium standards apply to protect that
employer's workers.
As pointed out by commenters such as the USW, similar exemptions
are included in other OSHA standards, including Benzene (29 CFR
1910.1028), Methylenedianiline (MDA) (29 CFR 1910.1050), and 1,3-
Butadiene (BD) (29 CFR 1910.1051). These exemptions were established
because workers in the exempted industries or workplaces were not
exposed to the subject chemical substances at levels of significant
risk. In the preamble to the MDA standard, OSHA states that the Agency
relied on data showing that worker exposure to mixtures or materials of
MDA containing less than 0.1 percent MDA did not create any hazards
other than those expected from worker exposure beneath the action level
(57 FR 35630, 35645-46). The exemption in the BD standard does not
apply where airborne concentrations generated by mixtures containing
less than 0.1 percent BD by volume can exceed the action level or STEL
(29 CFR 1910.1051(a)(2)(ii)). The exemption in the Benzene standard was
based on indications that exposures resulting from substances
containing trace amounts of benzene would generally be below the
exposure limit and on OSHA's determination that the exemption would
encourage employers to reduce the concentration of benzene in certain
substances (43 FR 27962, 27968).
OSHA's decision to maintain the 0.1 percent exemption and require
employers to demonstrate, using objective data, that the materials,
when processed or handled, cannot release beryllium in concentrations
at or above the action level as an 8-hour TWA under any foreseeable
conditions, is a change from proposed paragraph (a)(3) that specified
only that the standard did not apply to materials containing less than
0.1 percent beryllium by weight. This is also a change from Regulatory
Alternative #1b in another respect, insofar as it proposed requiring
objective data demonstrating that employee exposure to beryllium will
remain below both the proposed action level and STEL. OSHA removed the
STEL requirement as largely redundant because if exposures exceed the
STEL of 2.0 µg/m3\ for more than one 15-minute period per 8-hour
shift, even if exposures are non-detectable for the remainder of the
shift, the 8-hour TWA would exceed the action level of 0.1 μg/m3\.
Further, OSHA added the phrase "under any foreseeable conditions"
to paragraph (a)(3) of the final standards to make clear that limited
sampling results indicating exposures are below the
action level would be insufficient to take advantage of this exemption.
When using the phrase "any foreseeable conditions," OSHA is referring
to situations that can reasonably be anticipated. For example, annual
maintenance of equipment during which exposures could exceed the action
level would be a situation that is generally foreseeable.
In sum, the proposed standard covered occupational exposures to
beryllium in all forms, compounds, and mixtures in general industry. It
did not apply to articles, as defined by the HCS, or to materials
containing less than 0.1 percent beryllium by weight. After a thorough
review of the record, OSHA has decided to adopt Regulatory Alternative
#2a and include the construction and shipyard sectors within the scope
of the final rule. This decision was in response to the majority of
comments recommending that OSHA protect workers in these sectors under
the final rule and the exposure data in these sectors contained in the
record. OSHA has also decided to adopt a modified version of Regulatory
Alternative #1b and limit the 0.1 percent exemption to those employers
who have objective data demonstrating that employee exposure to
beryllium will remain below the action level as an 8-hour TWA under any
foreseeable conditions.
Therefore, the final rule contains three standards--one each for
general industry, construction, and shipyard. The article exemption has
remained unchanged, and the 0.1 percent exemption has been limited to
protect workers with significant exposures despite working with
materials with trace amounts of beryllium.
(b) Definitions
Paragraph (b) includes definitions of key terms used in the
standard. To the extent possible, OSHA uses the same terms and
definitions in the standard as the Agency has used in other OSHA health
standards. Using similar terms across health standards, when possible,
makes them more understandable and easier for employers to follow. In
addition, using similar terms and definitions helps to facilitate
uniformity of interpretation and enforcement.
Action level means a concentration of airborne beryllium of 0.1
micrograms per cubic meter of air (μg/m3\) calculated as an 8-hour
time-weighted average (TWA). Exposures at or above the action level
trigger requirements for periodic exposure monitoring when the employer
is following the scheduled monitoring option (see paragraph (d)(3)). In
addition, paragraph (f)(1)(i)(B) requires employers to list as part of
their written exposure control plan the operations and job titles
reasonably expected to have exposure at or above the action level.
Paragraph (f)(2) requires employers to ensure that at least one of the
controls listed in paragraph (f)(2)(i) is in place unless employers can
demonstrate for each operation or process either that such controls are
not feasible, or that employee exposures are below the action level
based on at least two representative personal breathing zone samples
taken at least seven days apart. In addition, under paragraph
(k)(1)(i)(A), employee exposure at or above the action level for more
than 30 days per year triggers requirements for medical surveillance.
The medical surveillance provision triggered by the action level allows
employees to receive exams at least every two years at no cost to the
employee. The action level is also relevant to the medical removal
requirements. Employees eligible for removal can choose to remain in
environments with exposures at or above the action level, provided they
wear respirators (paragraph (l)(2)(ii)). These employees may also
choose to be transferred to comparable work in environments with
exposures below the action level (if comparable work is not available,
the employer must maintain the employee's earnings and benefits for six
months or until comparable work becomes available (paragraph (l)(3)).
OSHA's risk assessment indicates that significant risk remains at
and below the TWA PEL (see this preamble at section VII, Significance
of Risk). When there is significant risk remaining at the PEL, the
courts have ruled that OSHA has the legal authority to impose
additional requirements, such as action levels, on employers to further
reduce risk when those requirements will result in a greater than
minimal incremental benefit to workers' health (Asbestos II, 838 F.2d
at 1274). OSHA concludes that an action level for beryllium exposure
will result in a further reduction in risk beyond that provided by the
PEL alone.
Another important reason to set an action level involves the
variable nature of employee exposures to beryllium. Because of this
fact, OSHA concludes that maintaining exposures below the action level
provides reasonable assurance that employees will not be exposed to
beryllium above the TWA PEL on days when no exposure measurements are
made. This consideration is discussed later in this section of the
preamble regarding paragraph (d)(3).
The United Steelworkers (USW) commented in support of the action
level, noting that it is typical in OSHA standards to have an action
level at one half of the PEL (Document ID 1681, p. 11). The USW also
commented that the "action level will further reduce exposure to
beryllium by workers and will incentivize employers to implement best
practice controls keeping exposures at a minimum as well as reducing
costs of monitoring and assessments" (Document ID 1681, p. 11).
National Jewish Health (NJH) also supported OSHA's proposal for a more
comprehensive standard and noted that the action level in the
Department of Energy's beryllium standard has been "very effective at
reducing exposures and rates of beryllium sensitization and chronic
beryllium disease in those facilities" (Document ID 1756, p. 90).
As noted by the commenters, OSHA's decision to set an action level
of one-half of the TWA PEL is consistent with previous standards,
including those for inorganic arsenic (29 CFR 1910.1018), chromium (VI)
(29 CFR 1910.1026), benzene (29 CFR 1910.1028), ethylene oxide (29 CFR
1910.1047), methylene chloride (29 CFR 1910.1052), and respirable
crystalline silica (29 CFR 1910.1053).
The definition of "action level" is therefore unchanged from the
proposal. Some of the ancillary provisions triggered by the action
level have changed since the proposal. Those changes are discussed in
more detail in the Summary and Explanation sections for those
provisions.
Airborne exposure and airborne exposure to beryllium mean the
exposure to airborne beryllium that would occur if the employee were
not using a respirator.
OSHA included a definition for the terms "exposure" and
"exposure to beryllium" in the proposed rule, and defined the terms
to mean "the exposure to airborne beryllium that would occur if the
employee were not using a respirator." In the final rule, the word
"airborne" is added to the terms to make clear that they refer only
to airborne beryllium, and not to dermal contact with beryllium. The
modified terms replace "exposure" and "exposure to beryllium" in
the rule, and the terms "exposure" and "exposure to beryllium" are
no longer defined.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, United States Department of Labor, or
designee. OSHA received no comments on this definition, and it is
unchanged from the proposal.
Beryllium lymphocyte proliferation test (BeLPT) means the
measurement of blood lymphocyte proliferation in a
laboratory test when lymphocytes are challenged with a soluble
beryllium salt. For additional explanation of the BeLPT, see the Health
Effects section of this preamble (section V). Under paragraph
(f)(1)(ii)(B), an employer must review and evaluate its written
exposure control plan when an employee is confirmed positive. The BeLPT
could be used to determine whether an employee is confirmed positive
(see definition of "confirmed positive" in paragraph (b) of this
standard). Paragraph (k)(3)(ii)(E) requires the BeLPT unless a more
reliable and accurate test becomes available.
NJH supported OSHA's definition of the BeLPT in the NPRM (Document
ID 1664, p. 5). However, OSHA has made one change from the proposed
definition of the BeLPT in the NPRM to the final definition to provide
greater clarity. The Agency has moved the characterization of a
confirmed positive result from the BeLPT definition to the "confirmed
positive" definition because it was more appropriate there.
Beryllium work area means any work area containing a process or
operation that can release beryllium where employees are, or can
reasonably be expected to be, exposed to airborne beryllium at any
level or where there is potential for dermal contact with beryllium.
The definition of "beryllium work area" has been changed from the
proposed definition to reflect stakeholder concerns regarding the
overlap between a beryllium work area and regulated area, and to
include the potential for dermal exposure. The definition only appears
in the general industry standard because the requirement for a
beryllium work area only applies to the general industry standard.
Beryllium work areas are areas where employees are or can reasonably be
expected to be exposed to airborne beryllium at any level, whereas an
area is a regulated area only if employees are or can reasonably be
expected to be exposed above the TWA PEL or STEL; the regulated area,
therefore, is either a subset of the beryllium work area or, less
likely, identical to it, depending on the configuration and
circumstances of the worksite. Dermal exposure has also been included
in the final definition to address the potential for sensitization from
dermal contact. Therefore, while not all beryllium work areas are
regulated areas, all regulated areas are beryllium work areas because
they are areas with employee exposure to beryllium. Accordingly, all
requirements for beryllium work areas also apply in all regulated
areas, but requirements specific to regulated areas apply only to
regulated areas and not to beryllium work areas where exposures do not
exceed the TWA PEL or STEL. For further discussion, see this section of
the preamble regarding paragraph (e), Beryllium work areas and
regulated areas.
The presence of a beryllium work area triggers a number of the
requirements in the general industry standard. Under paragraph
(d)(3)(i), employers must determine exposures for each beryllium work
area. Paragraphs (e)(1)(i) and (e)(2)(i) require employers to
establish, maintain, identify, and demarcate the boundaries of each
beryllium work area. Under paragraph (f)(1)(i)(D), employers must
minimize cross-contamination by preventing the transfer of beryllium
between surfaces, equipment, clothing, materials, and articles within a
beryllium work area. Paragraph (f)(1)(i)(F) states that employers must
minimize migration of beryllium from the beryllium work area to other
locations within and outside the workplace. Paragraph (f)(2) requires
employers to implement at least one of the controls listed in
(f)(2)(i)(A) through (D) for each operation in a beryllium work area
unless one of the exemptions in (f)(2)(ii) applies. Paragraph (i)(1)
requires employers to provide readily accessible washing facilities to
employees working in a beryllium work area, and to ensure that
employees who have dermal contact with beryllium wash any exposed skin
at the end of the activity, process, or work shift and prior to eating,
drinking, smoking, chewing tobacco or gum, applying cosmetics, or using
the toilet. In addition employers must ensure that these areas comply
with the Sanitation standard (29 CFR 1910.141) (paragraph (i)(4)).
Employers must maintain surfaces in all beryllium work areas as free as
practicable of beryllium (paragraph (j)(1)(i)). Paragraph (j)(2)
requires certain practices and prohibits other practices for cleaning
surfaces in beryllium work areas. Under paragraph (m)(4)(ii)(B),
employers must ensure workers demonstrate knowledge of the written
exposure control plan with emphasis on the location(s) of beryllium
work areas.
CBD diagnostic center means a medical diagnostic center that has an
on-site pulmonary specialist and on-site facilities to perform a
clinical evaluation for the presence of chronic beryllium disease
(CBD). This evaluation must include pulmonary function testing (as
outlined by the American Thoracic Society criteria), bronchoalveolar
lavage (BAL), and transbronchial biopsy. The CBD diagnostic center must
also have the capacity to transfer BAL samples to a laboratory for
appropriate diagnostic testing within 24 hours. The on-site pulmonary
specialist must be able to interpret the biopsy pathology and the BAL
diagnostic test results. For purposes of these standards, the term
"CBD diagnostic center" refers to any medical facility that meets
these criteria, whether or not the medical facility formally refers to
itself as a CBD diagnostic center. For example, if a hospital has all
of the capabilities required by this standard for CBD diagnostic
centers, the hospital would be considered a CBD diagnostic center for
purposes of these standards.
OSHA received comments from NJH and ORCHSE Strategies (ORCHSE)
regarding the definition of the "CBD diagnostic center." NJH
commented that CBD diagnostic centers do not need to be able to perform
the BeLPT but should be able to process the BAL appropriately and ship
samples within 24 hours to a facility that can perform the BeLPT. NJH
also indicated that CBD diagnostic centers should be able to perform CT
scans, pulmonary function tests with DLCO (diffusing capacity of the
lungs for carbon monoxide), and measure gas exchange abnormalities. NJH
further indicated that CBD diagnostic centers should have a medical
doctor who has experience and expertise, or is willing to obtain such
expertise, in the diagnosis and treatment of chronic beryllium disease
(Document ID 1664, pp. 5-6). ORCHSE argued that CBD diagnostic centers
should be allowed to rely on off-site interpretation of transbronchial
biopsy pathology, reasoning that this change would broaden the
accessibility of CBD diagnostic centers to more affected employees
(Document ID 1691, p. 3).
OSHA evaluated these recommendations and included the language
regarding sample processing and removed the proposal's requirement that
BeLPTs be performed on-site. The Agency also changed the requirement
that pulmonary specialist perform testing as outlined in the proposal
to the final definition which requires that a pulmonary specialist be
on-site. This requirement addresses the concerns ORCHSE raised about
accessibility of CBD diagnostic centers by increasing the number of
facilities that would qualify as centers. This also preserves the
expertise required to diagnose and treat CBD as stated by NJH (Document
1664, p. 6).
Paragraph (k)(7) includes provisions providing for an employee who
has been confirmed positive to receive an initial clinical evaluation
and subsequent medical examinations at a CBD diagnostic center.
Chronic beryllium disease (CBD) means a chronic lung disease
associated
with exposure to airborne beryllium. The Health Effects section of this
preamble, section V, contains more information on CBD. CBD is relevant
to several provisions of this standard. Under paragraph (k)(1)(i)(B),
employers must make medical surveillance available at no cost to
employees who show signs and symptoms of CBD. Paragraph (k)(3)(ii)(B)
requires medical examinations conducted under this standard to include
a physical examination with emphasis on the respiratory system, in
order to identify respiratory conditions such as CBD. Under paragraph
(k)(5)(i)(A), the licensed physician's report must advise the employee
on whether or not the employee has any detected medical condition that
would place the employee at an increased risk of CBD from further
exposure to beryllium. Furthermore, CBD is a criterion for medical
removal under paragraph (l)(1). Under paragraph (m)(1)(ii), employers
must address CBD in classifying beryllium hazards under the hazard
communication standard (HCS) (29 CFR 1910.1200). Employers must also
train employees on the signs and symptoms of CBD (see paragraph
(m)(4)(ii)(A) of the general industry and shipyard standards and
paragraph (m)(3)(ii)(A) of the construction standard).
Competent person means an individual on a construction site who is
capable of identifying existing and foreseeable beryllium hazards in
the workplace and who has authorization to take prompt corrective
measures to eliminate or minimize them. The competent person must have
the knowledge, ability, and authority necessary to fulfill the
responsibilities set forth in paragraph (e) of the standard for
construction. This definition appears only in the standard for
construction.
The competent person concept has been broadly used in OSHA
construction standards (e.g., 29 CFR 1926.32(f) and 1926.20(b)(2)),
including in the recent health standard for respirable crystalline
silica (29 CFR 1926.1153). Under 29 CFR 1926.32(f), competent person is
defined as "one capable of identifying existing and predictable
hazards in the surroundings or working conditions that are unsanitary,
hazardous, or dangerous to employees and who is authorized to take
prompt corrective measures to eliminate them." OSHA has adapted this
definition for the beryllium construction standard by specifying
"foreseeable beryllium hazards in the workplace" instead of
"predictable hazards in the surroundings or working conditions that
are unsanitary, hazardous, or dangerous to employees." The Agency also
replaced the word "one" with "an individual." The Agency revised
the phrase "to eliminate them" to read "to eliminate or minimize
them" to denote there may be cases where complete elimination would
not be feasible. The definition of competent person also indicates that
the competent person must have the knowledge, ability, and authority
necessary to fulfill the responsibilities set forth in paragraph (e) of
the construction standard, in order to ensure that the competent has
appropriate training, education, or experience. See the discussion of
"competent person" in the summary and explanation of paragraphs (e),
Beryllium work areas and regulated areas, and (f), Methods of
compliance, in this section.
Confirmed positive means the person tested has beryllium
sensitization, as indicated by two (either consecutive or non-
consecutive) abnormal BeLPT test results, an abnormal and borderline
test result, or three borderline test results. The definition of
"confirmed positive" also includes a single result of a more reliable
and accurate test indicating that a person has been identified as
sensitized to beryllium if the test has been validated by repeat
testing to have more accurate and precise diagnostic capabilities
within a single test result than the BeLPT. OSHA recognizes that
diagnostic tests for beryllium sensitization could eventually be
developed that would not require a second test to confirm
sensitization. Alternative test results would need to have comparable
or increased sensitivity, specificity and positive predictive value
(PPV) in order to replace the BeLPT as an acceptable test to evaluate
beryllium sensitization (see section V.D.5.b of this preamble).
OSHA received comments from NJH, the American Thoracic Society
(ATS) and ORCHSE regarding the requirement for consecutive test results
within a two year time frame, and the inclusion of borderline test
results (Document ID 1664, p.5; 1668, p. 2; 1691, p. 20). NJH and ATS
submitted similar comments regarding the requirement of two abnormal
BeLPT test results to be consecutive and within two years. According to
NJH, "the definition of `confirmed positive' [should] include two
abnormals, an abnormal and a borderline test result, and/or three
borderline tests. This recommendation is based on studies of Middleton
et al. (2008, and 2011), which showed that these other two combinations
result in a PPV similar to two abnormal test results and are an equal
predictor of CBD." (Document ID 1664, p. 5). In addition, the ATS
stated:
These test results need not be from consecutive BeLPTs or from a
second abnormal BeLPT result within a two-year period of the first
abnormal result. These recommendations are based on the many studies
cited in the docket, as well as those of Middleton, et al. (2006,
2008, and 2011), which showed that an abnormal and a borderline
result provide a positive predictive value (PPV) similar to that of
two abnormal test results for the identification of both beryllium
sensitization and for CBD (Document ID 1668, p. 2).
Materion Corporation (Materion) opposed changing the requirement
for two abnormal BeLPT results and opposed allowing two or three
borderline results to determine sensitization (Document ID 1808, p. 4).
Without providing scientific studies or other bases for its position,
Materion argued that "[m]aking a positive BeS determination for an
individual without any confirmed abnormal test result is not warranted
and clearly is not justifiable from a scientific, policy or legal
perspective" (Document ID 1808, p. 4).
OSHA evaluated these comments and modified the definition of
"confirmed positive" accordingly for reasons described more fully
within the Health Effects section of this preamble, V.D.5.b, including
reliance on the Middleton studies (2008, 2011). The original definition
for "confirmed positive" in the proposed standard was adapted from
the model standard submitted to OSHA by Materion and the USW in 2012.
Having carefully considered all these comments and their supporting
evidence, where provided, the Agency finds the arguments from NJH, ATS,
and ORCHSE persuasive. In particular ATS points out the Middleton et
al. studies ". . . showed that an abnormal and a borderline result
provide a positive predictive value (PPV) similar to that of two
abnormal test results for the identification of both beryllium
sensitization and for CBD." (Document ID. 1688 p. 3). Therefore, the
Agency recognizes that a borderline BeLPT test result when accompanied
by an abnormal test result, or three separate borderline test results,
should also be considered "confirmed positive."
In addition, ORCHSE commented on the use of a single test result
from a more reliable and accurate test (Document ID 1691, p. 20).
Specifically, ORCHSE recommended revising the language to include "the
result of a more reliable and accurate test such that beryllium
sensitization can be confirmed after one test, indicating a person has
been identified as having beryllium sensitization" (Document ID 1691,
p. 20). In response to the comment from ORCHSE, the Agency has included
additional language regarding the results from an alternative test
(Document ID 1691, p. 20). OSHA inserted additional language clarifying
that the alternative test has to be validated by repeat testing
indicating that it has comparable or increased sensitivity, specificity
and PPV than the BeLPT. The Agency finds that this language provides
more precise direction for acceptance of an alternative test.
Director means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee. The recordkeeping requirements mandate
that, upon request, employers make all records required by this
standard available to the Director (as well as the Assistant Secretary)
for examination and copying (see paragraph (n)(6)). Typically, the
Assistant Secretary sends representatives to review workplace safety
and health records. However, the Director may also review these records
while conducting studies such as Health Hazard Evaluations of
workplaces, or for other purposes. OSHA received no comments on this
definition, and it is unchanged from the proposal.
Emergency means any uncontrolled release of airborne beryllium. An
emergency could result from equipment failure, rupture of containers,
or failure of control equipment, among other causes.
An emergency triggers several requirements of this standard. Under
paragraph (g)(1)(iv), respiratory protection is required during
emergencies to protect employees from potential overexposures.
Emergencies also trigger clean-up requirements under paragraph
(j)(1)(ii), and medical surveillance under paragraph (k)(1)(i)(C). In
addition, under paragraph (m)(4)(ii)(D) of the standards for general
industry and shipyards and paragraph (m)(3)(ii)(D) of the standard for
construction, employers must train employees in applicable emergency
procedures.
High-efficiency particulate air (HEPA) filter means a filter that
is at least 99.97 percent effective in removing particles 0.3
micrometers in diameter (see Department of Energy Technical Standard
DOE-STD-3020-2005). HEPA filtration is an effective means of removing
hazardous beryllium particles from the air. The standard requires
beryllium-contaminated surfaces to be cleaned by HEPA vacuuming or
other methods that minimize the likelihood of exposure (see paragraphs
(j)(2)(i) and (ii)). OSHA received no comments on this definition, and
it is unchanged from the proposal.
Objective data means information, such as air monitoring data from
industry-wide surveys or calculations based on the composition of a
substance, demonstrating airborne exposure to beryllium associated with
a particular product or material or a specific process, task, or
activity. The data must reflect workplace conditions closely resembling
or with a higher airborne exposure potential than the processes, types
of material, control methods, work practices, and environmental
conditions in the employer's current operations.
OSHA did not include a definition of "objective data" in the
proposed rule. Use of objective data was limited in the proposed rule,
and applied only to an exception from initial monitoring requirements
in proposed paragraph (d)(2). Proposed paragraph (d)(2)(ii) included
criteria for objective data.
The final rule allows for expanded use of objective data. Paragraph
(a)(3) allows for use of objective data to support an exception from
the scope of the standards. Paragraph (d)(2) allows for use of
objective data as part of the performance option for exposure
assessment. OSHA is therefore including a definition of "objective
data" in paragraph (b) of the standards. The definition is generally
consistent with the criteria included in proposed paragraph (d)(2)(ii),
and with the use of this term in other OSHA substance-specific health
standards such as the standards addressing exposure to cadmium (29 CFR
1910.1027), chromium (VI) (29 CFR 1010.1026), and respirable
crystalline silica (29 CFR 1910.1053).
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice, such as
license, registration, or certification, allows the person to
independently provide or be delegated the responsibility to provide
some or all of the health care services required in paragraph (k). The
Agency recognizes that personnel qualified to provide medical
surveillance may vary from State to State, depending on State licensing
requirements. Whereas all licensed physicians would meet this
definition of PLHCP, not all PLHCPs must be physicians.
Under paragraph (k)(5) of the standards, the written medical report
for the employee must be completed by a licensed physician. Under
paragraph (k)(6) of the standard, the written medical opinion for the
employer must also be completed by a licensed physician. However, other
requirements of paragraph (k) may be performed by a PLHCP under the
supervision of a licensed physician (see paragraphs (k)(1)(ii),
(k)(3)(i), (k)(3)(ii)(F), (k)(3)(ii)(G), and (k)(5)(iii)). The standard
also identifies what information the employer must give to the PLHCP
providing the services listed in this standard, and requires that
employers maintain a record of this information for each employee (see
paragraphs (k)(4) and (n)(3)(ii)(C), and the summary and explanation of
paragraphs (k), Medical surveillance, in this section).
Allowing a PLHCP to provide some of the services required under
this rule is consistent with other recent OSHA health standards, such
as bloodborne pathogens (29 CFR 1910.1030), respiratory protection (29
CFR 1910.134), methylene chloride (29 CFR 1910.1052), and respirable
crystalline silica (29 CFR 1910.1053). OSHA received no comments on
this definition, and it is unchanged from the proposal.
Regulated area means an area, including temporary work areas where
maintenance or non-routine tasks are performed, where an employee's
airborne exposure exceeds, or can reasonably be expected to exceed,
either the TWA PEL or STEL. For an explanation of the distinction and
overlap between beryllium work areas and regulated areas, see the
definition of "beryllium work area" earlier in this section of the
preamble and the summary and explanation for paragraph (e), Beryllium
work areas and regulated areas. Regulated areas appear only in the
general industry and shipyard standards, and they trigger several other
requirements.
Paragraphs (e)(1)(ii) and (e)(2)(ii) require employers to establish
and demarcate regulated areas. Note that the demarcation requirements
for regulated areas are more specific than those for other beryllium
work areas (see also paragraph (m)(2) of the standards for general
industry and shipyards). Paragraph (e)(3) requires employers to
restrict access to regulated areas to authorized persons, and paragraph
(e)(4) requires employers to provide all employees in regulated areas
appropriate respiratory protection and personal protective clothing and
equipment, and to ensure that these employees use the required
respiratory protection and protective clothing and equipment. Paragraph
(i)(5)(i) prohibits employers from allowing employees to eat, drink,
smoke, chew tobacco or gum, or apply cosmetics in regulated areas.
Paragraph (m)(2) requires warning signs associated with regulated areas
to meet
certain specifications. Paragraph (m)(4)(ii)(B) requires employers to
train employees on the written exposure control plan required by
paragraph (f)(1), including the location of regulated areas and the
specific nature of operations that could result in airborne exposure.
In the proposed rule, OSHA included in the definition of the term
"regulated area" that it was "an area that the employer must
demarcate." Because the requirement to demarcate regulated areas is
presented elsewhere in the standards, the reference in the definition
to "an area that the employer must demarcate" is redundant, and has
been removed from the final definition of the term.
This definition of regulated areas is consistent with other
substance-specific health standards that apply to general industry and
shipyards, such as the standards addressing occupational exposure to
cadmium (29 CFR 1910.1027 and 29 CFR 1915.1027), benzene (29 CFR
1910.1028 and 29 CFR 1915.1028), and methylene chloride (29 CFR
1910.1052 and 29 CFR 1915.1052).
This standard means the beryllium standard in which it appears. In
the general industry standard, it refers to 29 CFR 1910.1024. In the
shipyard standard, it refers to 29 CFR 1915.1024. In the construction
standard, it refers to 29 CFR 1926.1124. This definition elicited no
comments and differs from the proposal only in that it appears in the
three separate standards.
(c) Permissible Exposure Limits (PELs)
Paragraph (c) of the standards establishes two permissible exposure
limits (PELs) for beryllium in all forms, compounds, and mixtures: An
8-hour time-weighted average (TWA) PEL of 0.2 μg/m3\ (paragraph
(c)(1)), and a 15-minute short-term exposure limit (STEL) of 2.0 μg/
m3\ (paragraph (c)(2)). The TWA PEL section of the standards requires
employers to ensure that no employee's exposure to beryllium, averaged
over the course of an 8-hour work shift, exceeds 0.2 μg/m3\. The
STEL section of the standards requires employers to ensure that no
employee's exposure, sampled over any 15-minute period during the work
shift, exceeds 2.0 μg/m3\. While the proposed rule contained
slightly different language in paragraph (c), i.e. requiring that
"each employee's airborne exposure does not exceed" the TWA PEL and
STEL, the final language was chosen by OSHA to remain consistent with
prior OSHA health standards and to clarify that OSHA did not intend a
different interpretation of the PELs in this standard. The same PELs
apply to general industry, construction, and shipyards.
TWA PEL. OSHA proposed a new TWA PEL of 0.2 μg/m3\ of
beryllium--one-tenth the preceding TWA PEL of 2 μg/m3\--because
OSHA preliminarily found that occupational exposure to beryllium at and
below the preceding TWA PEL of 2 μg/m3\ poses a significant risk of
material impairment of health to exposed workers. As with several other
provisions of these standards, OSHA's proposed TWA PEL followed the
draft recommended standard submitted to the Agency by Materion
Corporation (Materion) and the United Steelworkers (USW) (see this
preamble at section III, Events Leading to the Standards).
After evaluating the record, including published studies and more
recent exposure data from industrial facilities involved in beryllium
work, OSHA is adopting the proposed TWA PEL of 0.2 μg/m3\. OSHA has
made a final determination that occupational exposure to a variety of
beryllium compounds at levels below the preceding PELs poses a
significant risk to workers (see this preamble at section VII,
Significance of Risk). OSHA's risk assessment, presented in section VI
of this preamble, indicates that there is significant risk of beryllium
sensitization,\38\ CBD, and lung cancer from a 45-year (working life)
exposure to beryllium at the preceding TWA PEL of 2 μg/m3\. The
risk assessment further indicates that, although the risk is much
reduced, significant risk remains at the new TWA PEL of 0.2 μg/m3\.
---------------------------------------------------------------------------
\38\ As discussed in section VII of this preamble, Significance
of Risk, beryllium sensitization is a necessary precursor to
developing CBD.
---------------------------------------------------------------------------
OSHA has determined that the new TWA PEL is feasible across all
affected industry sectors (see section VIII.D of this preamble,
Technological Feasibility) and that compliance with the new PEL will
substantially reduce employees' risks of beryllium sensitization,
Chronic Beryllium Disease (CBD), and lung cancer (see section VI of
this preamble, Risk Assessment). OSHA's conclusion about feasibility is
supported both by the results of the Agency's feasibility analysis and
by the recommendation of the PEL of 0.2 μg/m3\ by Materion and the
USW.
Materion is the sole beryllium producer in the U.S., and its
facilities include some of the processes where OSHA expects it will be
most challenging to control beryllium exposures. Although OSHA also
found that there is significant risk at the proposed alternative TWA
PEL of 0.1 μg/m3\, OSHA did not adopt that alternative because the
Agency could not demonstrate technological feasibility at that level
(see section VIII.D of this preamble, Technological Feasibility).
The TWA PEL was the subject of numerous comments in the rulemaking
record. Comments from stakeholders in labor and industry, public health
experts, and the general public supported OSHA's selection of 0.2
μg/m3\ as the final PEL (NIOSH, Document ID 1671, Attachment 1, p.
2; National Safety Council, 1612, p. 3; The Sampling and Analysis
Subcommittee Task Group of the Beryllium Health and Safety Committee of
the Department of Energy's National Nuclear Security Administration
Lawrence Livermore National Lab (BHSC Task Group), 1655, p. 2; Newport
News Shipbuilding, 1657, p. 1; National Jewish Health (NJH),1664, p. 2;
The Aluminum Association, 1666, p. 1; The Boeing Company (Boeing),
1667, p. 1; American Industrial Hygiene Association (AIHA), 1686, p. 2;
United Steelworkers (USW), 1681, p. 7; Andrew Brown, 1636, p. 6;
Department of Defense, 1684, p. 1). Materion stated that the record
does not support the feasibility of any limit lower than 0.2 μg/m3\
(Document ID 1808, p. 2). OSHA also received comments supporting
selection of a lower TWA PEL of 0.1 μg/m3\ from Public Citizen, the
AFL-CIO, the United Automobile, Aerospace & Agricultural Implement
Workers of America (UAW), North America's Building Trades Unions
(NABTU), and the American College of Occupational and Environmental
Medicine (ACOEM) (Document ID 1689, p. 7; 1693, p. 3; 1670, p. 1; 1679,
pp. 6-7; 1685, p. 1; 1756, Tr. 167). These commenters based their
recommendations on the significant risk of material health impairment
from exposure at the TWA PEL of 0.2 μg/m3\ and below, which OSHA
acknowledges.
In addition to their concerns about risk, Public Citizen and the
American Federation of Labor and Congress of Industrial Organizations
(AFL-CIO) argued that a TWA PEL of 0.1 μg/m3\ is feasible (Document
ID 1756, Tr. 168-169, 197-198). As discussed further below, however,
OSHA's selection of the TWA PEL in this case was limited by the
findings of its technological feasibility analysis. No commenter
provided information that would permit OSHA to show the feasibility of
a TWA PEL of 0.1 μg/m3\ in industries where OSHA did not have
sufficient information to make this determination at the proposal
stage. Public Citizen instead argued that insufficient evidence that
engineering and work practice controls can maintain exposures at or
below a TWA PEL of 0.1
μg/m3\ should not preclude OSHA from establishing such a PEL; and
that workplaces unable to achieve a TWA PEL of 0.1 μg/m3\ should be
required to reduce airborne exposures as much as possible using
engineering and work practice controls, supplemented with a respiratory
protection program (Document ID 1670, p. 5).
OSHA has determined that Public Citizen's claim that the Agency
should find a PEL of 0.1 μg/m3\ technologically feasible is
inconsistent with the test for feasibility as described by the courts
as well as the evidence in the rulemaking record. OSHA bears the
evidentiary burden of establishing feasibility in a rulemaking
challenge. The D.C. Circuit, in its decision on OSHA's Lead standard
(United Steelworkers of America v. Marshall, 647 F.2d 1189 (D.C. Cir.
1981) ("Lead")), explained that in order to establish that a standard
is technologically feasible, "OSHA must prove a reasonable possibility
that the typical firm will be able to develop and install engineering
and work practice controls that can meet the PEL in most of its
operations" (Lead, 647 F.2d at 1272). "The effect of such proof,"
the court continued, "is to establish a presumption that industry can
meet the PEL without relying on respirators" (Lead, 647 F.2d at 1272).
The court's definition of technological feasibility thus recognizes
that, for a standard based on a hierarchy of controls prioritizing
engineering and work practice controls over respirators, a particular
PEL is not technologically feasible simply because it can be achieved
through the widespread use of respirators (see Lead, 647 F.2d at 1272).
OSHA's long-held policy of avoiding requirements that will result in
extensive respirator use is consistent with this legal standard.
In considering an alternative TWA PEL of 0.1 μg/m3\ that would
reduce risks to workers further than would the TWA PEL of 0.2 μg/
m3\, OSHA was unable to determine that this level was technologically
feasible. For some work operations, the evidence is insufficient for
OSHA to demonstrate that a TWA PEL of 0.1 μg/m3\ could be achieved
most of the time. In other operations, a TWA PEL of 0.1 μg/m3\
appears to be impossible to achieve without resort to respirators (see
section VIII.D of this preamble, Technological Feasibility, for a
detailed discussion of OSHA's feasibility findings). Thus, OSHA was
unable to meet its legal burden to demonstrate the technological
feasibility of the alternative TWA PEL of 0.1 μg/m3\ (see Lead, 647
F.2d at 1272; Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 990 (D.C.
Cir. 1991)) and has adopted the proposed PEL of 0.2 μg/m3\, for
which there is substantial evidence demonstrating technological
feasibility.
OSHA also invited comment on and considered an alternative TWA PEL
of 0.5 μg/m3\--two-and-a-half times greater than the proposed PEL
that it is adopting. As noted above, OSHA determined that significant
risk to worker health exists at the preceding PEL of 2.0 μg/m3\ as
well as at the new TWA PEL of 0.2 μg/m3\. Because OSHA found that a
TWA PEL of 0.2 μg/m3\ is technologically and economically feasible,
the Agency concludes that setting the TWA PEL at 0.5 μg/m3\--a
level that would leave workers exposed to even greater health risks
than they will face at the new PEL of 0.2 μg/m3\--would be contrary
to the OSH Act, which requires OSHA to eliminate the risk of material
health impairment "to the extent feasible" (29 U.S.C. 655(b)(5)).
Thus, the Agency is not adopting the proposed alternative TWA PEL of
0.5 μg/m3\.
Because significant risks of sensitization, CBD, and lung cancer
remain at the new TWA PEL of 0.2 μg/m3\, the final standards
include a variety of ancillary provisions to further reduce risk to
workers. These ancillary provisions include implementation of feasible
engineering controls in beryllium work areas, respiratory protection,
personal protective clothing and equipment, exposure monitoring,
regulated areas, medical surveillance, medical removal, hygiene areas,
housekeeping requirements, and hazard communication. The Agency has
determined that these provisions will reduce the risk beyond that which
the TWA PEL alone could achieve. These provisions are discussed later
in this Summary and Explanation section of the preamble.
STEL. OSHA is also promulgating a STEL of 2.0 μg/m3\, as
determined over a sampling period of 15 minutes. The new STEL of 2
μg/m3\ was suggested by the joint Materion-USW proposed rule and
proposed in the NPRM. As discussed in section VII of this preamble,
significant risks of sensitization, CBD, and lung cancer remain at the
TWA PEL of 0.2 μg/m3\. Where a significant risk of material
impairment of health remains at the TWA PEL, OSHA must impose a STEL if
doing so would further reduce risk and is feasible to implement (Pub.
Citizen Health Research Grp. v. Tyson, 796 F.2d 1479, 1505 (D.C. Cir.
1986) ("Ethylene Oxide"); see also Building and Construction Trades
Department, AFL-CIO v. Brock, 838 F.2d 1258, 1271 (D.C. Cir. 1988)). In
this case, the evidence in the record demonstrates that the STEL is
feasible and that it will further reduce the risk remaining at the TWA
PEL. The goal of a STEL is to protect employees from the risk of harm
that can occur as a result of brief exposures that exceed the TWA PEL.
Without a STEL, the only protection workers would have from high short-
duration exposures is that, when those exposures are factored in, they
cannot exceed the cumulative 8-hour exposure at the proposed 0.2 μg/
m3\ TWA PEL (i.e., 1.6 μg/m3\). Since there are 32 15-minute
periods in an 8-hour work shift, a worker's 15-minute exposure in the
absence of a STEL could be as high as 6.4 μg/m3\ (32 x 0.2 μg/
m3\) if that worker's exposures during the remainder of the 8-hour
work shift are non-detectable. A STEL serves to minimize high, task-
based exposures by requiring feasible controls in these situations, and
has the added effect of further reducing the 8-hour TWA exposure.
OSHA believes a STEL for beryllium will help reduce the risk of
sensitization and CBD in beryllium-exposed employees. As discussed in
this preamble at section V, Health Effects, beryllium sensitization is
the initial step in the development of CBD. Sensitization has been
observed in some workers who were only exposed to beryllium for a few
months (see section V.D.1 of this preamble), and tends to be more
strongly associated with 'peak' and highest-job-worked exposure metrics
than cumulative exposure (see section V.D.5 of this preamble). Short-
term exposures to beryllium have also been shown to contribute to the
development of lung disease in laboratory animals (see this preamble at
section V, Health Effects). These study findings indicate that adverse
effects to the lung may occur from beryllium exposures of relatively
short duration. Thus OSHA expects a STEL to add further protection from
the demonstrated significant risk of harm than that afforded by the new
0.2 μg/m3\ TWA PEL alone.
STEL exposures are typically associated with, and need to be
measured by the employer during, the highest-exposure operations that
an employee performs (see paragraph (d)(3)(ii)). OSHA has determined
that the STEL of 2.0 μg/m3\ can be measured for this brief period
of time using OSHA's available sampling and analytical methodology, and
that feasible means exist to maintain 15-minute short-term exposures at
or below the proposed STEL (see section VIII.D of this preamble,
Technological Feasibility). Comments on the STEL were generally
supportive of OSHA's
decision to include a beryllium STEL, but differed on the appropriate
level. NIOSH recommended a STEL of at most 1 μg/m3\, noting that
available exposure assessment methods are sensitive enough to support a
STEL of 1 μg/m3\ and that it is likely to be more protective than
the proposed STEL of 2 μg/m3\ (Document ID 1960, Attachment 2, p.
4; 1725, p. 35; 1755, Tr. 22). NJH's comments also supported a STEL of
1 μg/m3\ as the best option (Document ID 1664, p. 3). Public
Citizen and the AFL-CIO advocated for a STEL of 1 μg/m3\, stating
that it would be more protective than the proposed STEL of 2 μg/m3\
(Document ID 1670, p. 6; 1689, p. 7-8). The AFL-CIO and Public Citizen
both stated that a STEL of 1 μg/m3\ is supported in the record,
including by exposure data from OSHA workplace inspections (Document ID
1670, p. 6; 1756, Tr. 171). However, no additional engineering controls
capable of reducing short term exposures to or below 1.0 μg/m3\
were identified by commenters. Public commenters did not provide any
empirical data to suggest that those exposed to working conditions
associated with a STEL of 2.0 μg/m3\ would be more likely to be
sensitized than those exposed to working conditions associated with a
STEL of 1.0 μg/m3\. However, OSHA notes that the available
epidemiological literature on beryllium-related disease does not
address the question of whether those exposed to working conditions
associated with a STEL of 2.0 μg/m3\ would be more likely to be
sensitized than those exposed to working conditions associated with a
STEL of 1.0 μg/m3\. Detailed documentation of workers' short-term
exposures is typically not available to researchers. Therefore, OSHA
cannot exclusively rely on evidence relating health effects to specific
short-term exposure levels to set a STEL. In setting a STEL, OSHA also
examines the likelihood that a given STEL will help to reduce
excursions above the TWA PEL and the feasibility of meeting a given
STEL using engineering controls. The UAW emphasized that "OSHA must
include the STEL in the standard to ensure that peak exposures are
characterized and controlled" (Document ID 1693, p. 3). The UAW
argued, specifically, for a STEL of five times the PEL (recommending a
STEL of 0.5 μg/m3\ based on a TWA PEL of 0.1 μg/m3\), noting
that single short-term, high-level beryllium exposures can lead to
sensitization, and that UAW members in industries such as nonferrous
foundries and scrap metal reclamation may experience such exposures
even when not exposed above the 8 hour TWA PEL (Document ID 1693, p.
3). Ameren Services Company, a public utility that includes electric
power generation companies, expressed support for the proposed PEL and
STEL, but also expressed support for selecting a STEL of five times the
PEL in order to maintain consistency with OSHA's typical approach to
setting STELs (Document ID 1675, p. 3).
In contrast, NGK Metals Corporation (NGK) supported the proposed
STEL of 2 μg/m3\, and specifically argued against a STEL of 0.5
μg/m3\ on the basis that a reduced STEL would not be feasible or
offer significantly more protection than the proposed STEL (Document ID
1663, p. 4). Materion emphasized the need for "proactive operational
control" of tasks that could generate high, short-term beryllium
exposures, and supported the STEL of 2 μg/m3\ contained in OSHA's
proposed rule (Document ID 1661, pp. 3, 5). Materion indicated in its
comments that the proposed STEL of 2.0 μg/m3\ was based on
controlling the upper range of worker short term exposures (Document ID
1661). Materion used data provided in the Johnson study of the United
Kingdom Atomic Weapons Establishment (AWE) in Cardiff, Wales, as
supporting evidence for the proposed STEL (Document ID 1505). However,
Dr. Christine Schuler from NIOSH commented that the AWE study was not
an appropriate basis for an OSHA STEL because the AWE study was based
on workers showing physical signs of CBD ("If somebody became really
apparently ill, then they would have identified them.") (Document ID
1755, Tr. 35). Dr. Schuler additionally commented that the studies
performed in the United States are more appropriate since they are
based on identified cases of CBD at an earlier stage where there are
generally very few symptoms (called asymptomatic or subclinical)
(Document ID 1755, Tr. 34-35). OSHA agrees with Dr. Schuler's
assessment and that the AWE study should not be used as scientific
evidence to support a STEL of 2.0 μg/m3\.
After careful consideration of the record, including all available
data and stakeholder comments, OSHA has reaffirmed its preliminary
determinations that a STEL of 2.0 μg/m3\ (ten times the final PEL
of 0.2 μg/m3\) is technologically feasible and will help reduce the
risk of beryllium-related health effects in exposed employees. As
discussed in section VIII.D of this preamble, Technological
Feasibility, OSHA has determined that the implementation of engineering
and work practice controls required to maintain full shift exposures at
or below a PEL of 0.2 μg/m3\ will reduce short term exposures to
2.0 μg/m3\ or below. However, adopting a STEL of 1.0 μg/m3\ or
lower would likely require additional respirator use in some
situations. Thus, OSHA has retained the proposed value of 2.0 μg/
m3\ as the final STEL.
OSHA also received a comment from Paul Wambach, (an independent
commenter) stating that a STEL should not be included in the final
rule, arguing that the diseases associated with beryllium exposure are
chronic in nature and therefore are not affected by brief excursions
above the TWA PEL (Document ID 1591, p. 1). However, as discussed
above, OSHA has determined that there is sufficient evidence that
brief, high-level exposures to beryllium contribute to the development
of beryllium sensitization and CBD to support inclusion of a STEL in
the final rule (see this preamble at section V, Health Effects). This
comment also discussed the statistical relationship between a 15-minute
STEL and 8-hour TWA PEL and issues of sampling strategy, discussed in
section VIII.D of this preamble, Technological Feasibility.
CFR Entries. OSHA's preceding PELs for "beryllium and beryllium
compounds," were contained in 29 CFR 1910.1000 Table Z-2 for general
industry. Table Z-2 contained two PELs: (1) A 2 μg/m3\ TWA PEL, and
(2) a ceiling concentration of 5 μg/m3\ that employers must ensure
is not exceeded during the 8-hour work shift, except for a maximum peak
of 25 μg/m3\ over a 30-minute period in an 8-hour work shift. The
preceding PELs for beryllium and beryllium compounds in shipyards (29
CFR 1915.1000 Table Z) and construction (29 CFR 1926.55 Appendix A)
were also 2 μg/m3\, but did not include ceiling or peak exposure
limits. OSHA adopted the preceding PELs in 1972 pursuant to section
6(a) of the OSH Act (29 U.S.C. 655(a)). The 1972 PELs were based on the
1970 American National Standards Institute (ANSI) Beryllium and
Beryllium Compounds standard (Document ID 1303), which in turn was
based on a 1949 U.S. Atomic Energy Commission adoption of a threshold
limit for beryllium of 2.0 μ/m3\ and was included in the 1971
American Conference of Governmental Industrial Hygienists Documentation
of the Threshold Limit Values for Substances in Workroom Air (Document
ID 0543).
OSHA is revising the entry for beryllium and beryllium compounds in
29 CFR 1910.1000 Table Z-1 to cross-reference the new general industry
standard, 1910.1024. A comparable revision to 29 CFR 1915.1000 Table Z
cross-references the shipyard standard, 1915.1024, and 29 CFR 1926.55
Appendix A is revised to cross-reference the construction standard,
1926.1124. A footnote is added to 29 CFR 1910.1000 Table Z-1, which
refers to 29 CFR 1910.1000 Table Z-2 for situations when the new
exposure limits in 1910.1024 are stayed or otherwise not in effect. The
preceding PELs for beryllium are retained in 29 CFR 1910.1000 Table Z-
2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A. Footnotes
are added to these tables to make clear that the preceding PELs apply
to any sectors or operations where the new TWA PEL of 0.2 μg/m3\
and STEL of 2.0 μg/m3\ are not in effect. The preceding PELs are
also applicable during the time between publication of the beryllium
rule and the dates established for compliance with the rule, as well as
in the event of regulatory delay, a stay, or partial or full
invalidation by the Court.
(d) Exposure Assessment
Paragraph (d) of the final standards for general industry,
construction, and shipyards sets forth requirements for assessing
employee exposures to beryllium. The requirements are issued pursuant
to section 6(b)(7) of the OSH Act, which mandates that any standard
promulgated under section 6(b) shall, where appropriate, "provide for
monitoring or measuring employee exposure at such locations and
intervals, and in such manner as may be necessary for the protection of
employees." 29 U.S.C. 655(b)(7). Consistent with the definition of
"airborne exposure" in paragraph (b) of these standards, exposure
monitoring results must reflect the exposure to airborne beryllium that
would occur if the employee were not using a respirator. Exposures must
be assessed using the new performance option (i.e., use of any
combination of air monitoring data or objective data sufficient to
accurately characterize employee exposures) or by following the
scheduled monitoring option (with the frequency of monitoring
determined by the results of the initial and subsequent monitoring).
The performance option provides flexibility for employers who are able
to accurately characterize employee exposures through alternative
methods like objective data and has been successfully applied in the
Chromium (VI) standard and recently included in the respirable
crystalline silica standard. The scheduled monitoring option provides a
framework that is familiar to many employers, having been a customary
practice in past substance-specific OSHA health standards. Under either
option, employers must assess the exposure of each employee who is or
may reasonably be expected to be exposed to airborne beryllium.
In the proposed exposure monitoring provision, OSHA required
employers to assess the exposure of employees who are, or may
reasonably be expected to be, exposed to airborne beryllium. This
obligation consisted of an initial exposure assessment, unless the
employer relied on objective data to demonstrate that exposures would
be below the action level or the short term exposure level (STEL) under
any expected conditions; periodic exposure monitoring (at least
annually if initial exposure monitoring indicates that exposures are at
or above the action level and at or below the time-weighted average
(TWA) PEL); and additional monitoring if changes in the workplace could
reasonably be expected to result in new or additional exposures to
beryllium. In the proposed rule, monitoring to determine employee TWA
exposures had to represent the employee's average exposure to airborne
beryllium over an eight-hour workday. STEL exposures had to be
characterized by sampling periods of 15 minutes for each operation
likely to produce exposures above the STEL. Samples taken had to
reflect the exposure of employees on each work shift, for each job
classification, in each beryllium work area. Samples had to be taken
within an employee's breathing zone. The proposed rule also included
provisions for employee notification of monitoring results and
observation of monitoring.
OSHA received comments on a variety of issues pertaining to the
proposal's exposure monitoring provision. In hearing testimony, Dr.
Lisa Maier from National Jewish Health (NJH) expressed general support
for exposure monitoring in the workplace "to target areas that are at
or above the action level and to regulate these areas to trigger
administrative controls" (Document ID 1756, Tr. 108). All other
comments regarding the exposure monitoring requirements focused on
specific areas of those requirements and are discussed in the
appropriate subject section below.
OSHA has retained the provisions related to exposure assessment in
the final standards. These provisions are important because assessing
employee exposure to toxic substances is a well-recognized and accepted
risk management tool. As the Agency noted in the proposal, the purposes
of requiring assessment of employee exposures to beryllium include
determination of the extent and degree of exposure at the worksite;
identification and prevention of employee overexposure; identification
of the sources of exposure to beryllium; collection of exposure data so
that the employer can select the proper control methods to be used; and
evaluation of the effectiveness of those selected methods. Assessment
enables employers to meet their legal obligation to ensure that their
employees are not exposed in excess of the permissible exposure limit
(PEL) or short-term exposure limit (STEL) and to ensure employees have
access to accurate information about their exposure levels, as required
by section 8(c)(3) of the Act, 29 U.S.C. 657(c)(3). In addition,
exposure data enable physicians or other licensed health care
professionals (PLHCPs) performing medical examinations to be informed
of the extent of the worker's exposure to beryllium.
In the final standards, paragraph (d) is now titled "Exposure
assessment." This change from "exposure monitoring" in the proposal
to "exposure assessment" in the final standards was made to align the
provision's purpose with the broader concept of exposure assessment
beyond conducting air monitoring, including the use of objective data.
General Requirements. Proposed paragraph (d)(1)(i) contained the
general requirement that the exposure assessment provisions would apply
when employees "are, or may reasonably be expected to be, exposed to
airborne beryllium." OSHA did not receive comment on this specific
provision. However, in paragraph (d)(1) of the final standards for
general industry, construction, and shipyards, the Agency has changed
the proposed requirement that "These exposure monitoring requirements
apply when employees are, or may reasonably be expected to be, exposed
to airborne beryllium" to "The employer must assess the airborne
exposure of each employee who is or may reasonably be expected to be
exposed to airborne beryllium." This change aligns the language to
other OSHA standards such as respirable crystalline silica (29 CFR
1910.1053) and hexavalent chromium ([delta]1910.1026) as well as
clarifies the employer's obligation to assess each employee's beryllium
exposure. Additionally, for reasons discussed below, paragraph (d)(1)
of the final standards now requires the employer to assess employee
exposure in accordance with either the new performance option, added at
paragraph (d)(2), or the scheduled monitoring option, moved to
paragraph (d)(3) of this section. Changes from the proposed exposure
monitoring provision also include an increased
frequency schedule for periodic monitoring and a requirement to perform
periodic exposure monitoring when exposures are above the PEL in the
scheduled monitoring option in paragraph (d)(3)(vi) and when exposures
are above the STEL in the scheduled monitoring option in paragraph
(d)(3)(viii).
Proposed paragraphs (d)(1)(ii)-(v) have been moved to different
paragraphs in the final standards and will be discussed in the
appropriate sections below.
The performance option. Proposed paragraph (d)(2) set forth initial
exposure monitoring requirements and the circumstances under which
employers do not need to conduct initial exposure monitoring. In the
proposal, employers did not have to conduct initial exposure monitoring
if they relied on historical data or objective data. The proposal also
set forth requirements for the sufficiency of any historical data or
objective data used to satisfy proposed paragraph (d)(2). OSHA has
decided to remove this provision from the final standards as part of
the change to allow employers to choose between the scheduled
monitoring option and the performance option for all exposure
assessment. Paragraph (d)(2) of the final standards for general
industry, construction, and shipyards describes the exposure assessment
performance option. OSHA has included this option because it provides
employers flexibility to assess the 8-hour TWA and STEL exposure for
each employee on the basis of any combination of air monitoring data or
objective data sufficient to accurately characterize employee exposures
to beryllium. OSHA recognizes that exposure monitoring may present
challenges in certain instances, particularly when tasks are of short
duration or performed under varying environmental conditions. The
performance option is intended to allow employers flexibility in
assessing the beryllium exposures of their employees. The performance
option for exposure assessment is consistent with other OSHA standards,
such as those for exposure to respirable crystalline silica (29 CFR
1910.1053) and chromium (VI) (29 CFR 1910.1026).
When the employer elects the performance option, the employer must
initially conduct the exposure assessment and must demonstrate that
employee exposures have been accurately characterized. As evident in
final paragraph (d)(3), OSHA considers exposures to be accurately
characterized when they reflect the exposures of employees on each
shift, for each job classification, in each work area. However, under
this option, the employer has flexibility to determine how to achieve
this. For example, under this option an employer could determine that
there are no differences between the exposure of an employee in a
certain job classification who performs a task in a particular work
area on one shift and the exposure of another employee in the same job
classification who performs the same task in the same work area on
another shift. In that case, the employer could characterize the
exposure of the second employee based on the first employee's exposure.
Accurately characterizing employee exposures under the performance
option is also an ongoing duty. In order for exposures to continue to
be accurately characterized, the employer is required to reassess
exposures whenever a change in production, process, control equipment,
personnel, or work practices may reasonably be expected to result in
new or additional exposures at or above the action level or STEL, or
when the employer has any reason to believe that new or additional
exposures at or above the action level have occurred (see discussion
below of paragraph (d)(4) of the final standards for general industry,
construction, and shipyards).
When using the performance option, the burden is on the employer to
demonstrate that the data accurately characterize employee exposure.
However, the employer can characterize employee exposure within a
range, in order to account for variability in exposures. For example,
an employer could use the performance option and determine that an
employee's exposure is above the action level but below the PEL. Based
on this exposure assessment, the employer would be required under
paragraph (k)(1)(i)(A) to provide medical surveillance if the employee
is exposed for more than 30 days per year.
OSHA has not included specific criteria for implementing the
performance option in the final standards. Because the goal of the
performance option is to give employers flexibility to accurately
characterize employee exposures using whatever combination of air
monitoring data and objective data is most appropriate for their
circumstances, OSHA concludes it would be inconsistent to specify in
the standards exactly how and when data should be collected. When an
employer wants a more structured approach for meeting their exposure
assessment obligations, it may opt for the scheduled monitoring option.
OSHA does, however, offer two clarifying points. First, the Agency
clarifies that when using the term "air monitoring data" in this
paragraph, OSHA refers to any monitoring conducted by the employer to
comply with the requirements of these standards, including the
prescribed accuracy and confidence requirements in paragraph (d)(5).
Second, objective data can include historic air monitoring data, but
that data must reflect workplace conditions closely resembling or with
a higher airborne exposure potential than the processes, types of
material, control methods, work practices, and environmental conditions
in the employer's current operations. Additional discussion of the
types of data and exposure assessment strategies that may be used by
employers as "objective data" to accurately characterize employee
exposures to beryllium can be found in the summary and explanation of
"objective data" in paragraph (b) ("Definitions").
Where employers rely on objective data generated by others as an
alternative to developing their own air monitoring data, they will be
responsible for ensuring that the data relied upon from other sources
are accurate measures of their employees' exposures. Thus, the burden
is on the employer to show that the exposure assessment is sufficient
to accurately characterize employee exposures to beryllium.
As with the Chromium (VI) standard, 29 CFR 1910.1026, OSHA does not
limit when objective data can be used to characterize exposure. OSHA
permits employers to rely on objective data for meeting their exposure
assessment obligations, even where exposures may exceed the action
level or PEL. OSHA's intent is to allow employers flexibility to assess
employee exposures to beryllium, but to ensure that the data used are
accurate in characterizing employee exposures. For example, where an
employer has a substantial body of data (from previous monitoring,
industry-wide surveys, or other sources) indicating that employee
exposures in a given task are between the action level and PEL, the
employer may choose to rely on those data to determine his or her
compliance obligations (e.g., medical surveillance).
OSHA has also not established time limitations for air monitoring
results used to characterize employee exposures under the performance
option. The burden is on the employer to show that the data accurately
characterize employee exposure to beryllium. This burden applies to the
age of the data as well as to the source of the data. For example,
monitoring results obtained 18 months prior to the effective date of
the standards could be
used to determine employee exposures, but only if the employer could
show that the data were obtained during work operations conducted under
conditions closely resembling the processes, types of material, control
methods, work practices, and environmental conditions in the employer's
current operations. Regardless of when they were collected, the data
must accurately reflect current conditions.
Any air monitoring data relied upon by employers must be maintained
and made available in accordance with the recordkeeping requirements in
paragraph (n)(1) of the final standards for general industry,
construction, and shipyards. Any objective data relied upon must be
maintained and made available in accordance with the recordkeeping
requirements in paragraph (n)(2) of the standards.
The scheduled monitoring option. Paragraph (d)(3) of the final
standards for general industry, construction, and shipyards describes
the scheduled monitoring option. Parts of the scheduled monitoring
option in the final standards come from proposed paragraphs (d)(1)(ii)-
(iv), which set out the general exposure monitoring requirements.
Proposed paragraph (d)(1)(ii) required the employer to determine the 8-
hour TWA exposure for each employee, and proposed paragraph (d)(1)(iii)
required the employer to determine the 15-minute short-term exposure
for each employee. Both proposed paragraph (d)(1)(ii) and (d)(1)(iii)
required breathing zone samples to represent the employee's exposure on
each work shift, for each job classification, in each beryllium work
area.
Some commenters disagreed with the requirement to perform exposure
monitoring on each work shift. NGK stated that sampling on each shift
is overly burdensome and unnecessary since samples are collected from
those employees who are expected to have the highest exposure (Document
ID 1663, p. 1). Materion and the United Steelworkers (USW) recommended
representative sampling instead of sampling all employees, and sampling
from the shift expected to have the highest exposures (Document ID
1680, p. 3). Materion separately commented that monitoring on all three
shifts is not warranted, would be burdensome to small businesses, and
does not align well with other standards (Document ID 1661, p. 14
(pdf)). In post-hearing comments, Materion submitted an analysis of
exposure variation by shift at one of their facilities and argued that
the data are the best available evidence that monitoring on all three
shifts is not justifiable or necessary to fulfill the requirements of
the OSH Act (Document ID 1807, Attachment 1, p. 5, Attachment 7, p. 82;
1958, pp. 5-6). In an individual submission, the USW also stated that
three-shift monitoring would add unnecessary compliance costs.
Additionally, it commented that if the operations are identical, the
shift chosen will not matter, while if they are not identical, then
monitoring on the highest exposed shift will overestimate exposures on
the other shifts (Document ID 1681, Attachment 1, p. 8). Conversely,
the American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO) noted in post-hearing comments that widely
accepted industrial hygiene practice includes exposure monitoring
during different shifts, tasks, and times of the year and that
monitoring is specifically designed this way to characterize exposure
under different conditions (Document ID 1809, p. 1). During the
hearings, Dr. Virji from NIOSH testified that because exposure is
variable and "different things happen at different shifts," including
maintenance activities, "it is hard to . . . gauge . . . which shift
[has] the highest exposure," so "it is important that multiple shifts
get representative sampling" (Document ID 1755, Tr. 50-51).
OSHA agrees with the AFL-CIO and Dr. Virji and has retained the
requirement in proposed paragraphs (d)(1)(ii) and (iii) that samples
reflect exposures on each shift, for each job classification, and in
each work area. This requirement is included in final paragraphs
(d)(3)(i) and (ii). However, in response to the comments from Materion
and the USW, OSHA restructured the exposure assessment requirements in
order to provide employers with greater flexibility to meet their
exposure assessment obligations by using either the performance option
or the scheduled monitoring option depending on the operation and
information available. OSHA believes that conducting exposure
assessment on a specific schedule provides employers with a workable
structure to properly assess their employees' exposure to beryllium and
provides sufficient information for employers to make informed
decisions regarding exposure prevention measures. Alternatively, the
performance option provides employers with flexibility in accurately
characterizing employee exposures to beryllium on the bases of any
combination of air monitoring and objective data.
Comments submitted from Mr. Paul Wambach, a private citizen, stated
that the proposed short-term exposure limit (STEL) of 2 μg/m3\ has
the potential for being misinterpreted as requiring the use of
impractical exposure monitoring methods that would require collecting
32 consecutive 15-minute samples while providing no real health
protection benefit and should be dropped from the final rule (Document
ID 1591, p. 3). OSHA's intent, however, is that compliance with the
STEL can be assessed using a task specific monitoring strategy, during
which representative 15-minute samples can be taken to evaluate peak
exposures. OSHA maintains that consistent with the comments from
Materion, the identification and control of short-term exposures is
critical to the protection of worker health from exposure to beryllium.
OSHA has decided to include the scheduled monitoring option in the
final standards because it provides employers with a clearly defined,
structured approach to assessing employee exposures. Under paragraph
(d)(3)(i) of the final standards, employers who select the scheduled
monitoring option must conduct initial monitoring to determine employee
exposure to beryllium. Air monitoring to determine employee exposures
must represent the employee's 8-hour TWA exposure to beryllium. Final
paragraph (d)(3)(ii) requires the employer to perform initial
monitoring to assess the employee's 15-minute short-term exposure.
Under both paragraphs (d)(3)(i) and (d)(3)(ii), samples must be taken
within the employee's personal breathing zone, and must represent the
employee's airborne exposure on each shift, for each job
classification, in each work area. In the final standards, OSHA has
changed "in each beryllium work area" to "in each work area" to
avoid confusion with the beryllium work areas defined in paragraphs (b)
and (e) of the final standard for general industry. In other OSHA
standards, the term "work area" is used to describe the general
worksite where employees are present and performing tasks or where work
processes and operations are being carried out. Employers following the
scheduled monitoring option should conduct initial monitoring as soon
as work on a task or project involving beryllium exposure begins so
they can identify situations where control measures are needed.
Representative sampling. Paragraph (d)(3)(iii) of the final
standards, like proposed paragraph (d)(1)(iv), describes the
circumstances under which employers may use representative sampling.
Proposed paragraphs (d)(1)(iv)(A)-(C) permitted the use of
representative sampling to characterize exposures of non-sampled
employees, provided that the employer performed such sampling where
several employees performed the same job tasks, in the same job
classification, on the same work shift, and in the same work area, and
had similar duration and frequency of exposure; took breathing zone
samples sufficient to accurately characterize exposure on each work
shift, for each job classification, in each work area; and sampled the
employees expected to have the highest exposure.
The USW and AFL-CIO supported the representative sampling provision
in OSHA's proposed exposure monitoring requirements (Document ID 1681,
p. 8; 1689, p. 11). OSHA has decided to retain the representative
sampling provision in the final standards to provide employers with
greater flexibility in meeting their exposure assessment obligations.
Under the scheduled monitoring option, just as under the performance
option, employers must accurately characterize the exposure of each
employee to beryllium. In some cases, this will entail monitoring all
exposed employees. In other cases, monitoring of "representative"
employees is sufficient. As in the proposal, representative exposure
sampling is permitted under the final standards when several employees
perform the same tasks on the same shift and in the same work area.
However, OSHA has not included the requirement in proposed paragraph
(d)(1)(iv)(A) that employees "have similar duration and frequency of
exposure" in final paragraph (d)(3)(iii). This provision is
unnecessary because final paragraph (d)(3)(iii), like proposed
paragraph (d)(1)(iv)(C), requires the employer to sample the
employee(s) expected to have the highest exposures to beryllium.
Additionally, the requirement in proposed paragraph (d)(1)(iv)(B) that
employers take "sufficient breathing zone samples to accurately
characterize exposure on each work shift, for each job classification,
in each work area" has been removed because when performing exposure
monitoring under final paragraphs (d)(3)(i) or (d)(3)(ii), employers
already must assess exposures based on personal breathing zone air
samples that reflect the airborne exposure of employees on each shift,
for each job classification, and in each work area. Under these
conditions, OSHA expects that exposures will be accurately
characterized.
Finally, the proposed requirement in paragraph (d)(1)(iv)(C) that
employers must monitor the employee(s) expected to have the highest
exposures has been retained in the final standards. For example, this
could involve monitoring the beryllium exposure of the employee closest
to an exposure source. The exposure result may then be attributed to
other employees who perform the same tasks on the same shift and in the
same work area. Exposure assessment should include, at a minimum, one
full-shift sample and one 15 minute sample taken for each job
classification, in each work area, for each shift.
Where employees are not performing the same tasks on the same shift
and in the same work area, representative sampling will not adequately
characterize actual exposures of those employees, and individual
monitoring is necessary.
Frequency of monitoring under scheduled monitoring option.
Paragraph (d)(3) of the proposed standard required periodic monitoring
at least annually if initial exposure monitoring indicated that
exposures were at or above the action level and at or below the TWA
PEL. The proposal did not require periodic exposure monitoring if
initial monitoring indicated that exposures were below the action
level.
In the NPRM, OSHA solicited comment on the reasonableness of
discontinuing monitoring based on one sample below the action level. In
response, many commenters discussed the importance of taking multiple
samples to evaluate a worker's exposure even if initial results are
below the action level. NJH emphasized that "[i]t is NOT reasonable to
discontinue monitoring after one sample result below the action level"
because "a single sample result does not reflect the random variation
in sampling and analytical methods" (Document ID 1664, p. 6). NIOSH
commented that, because occupational exposure distributions are right-
skewed (i.e., the mean is higher than the median so most sample results
will be below the average exposure level), collecting fewer samples
leads to a higher likelihood of showing compliance when it may not be
warranted (Document ID 1671, Attachment 1, p. 6). Also during the
hearings, Marc Kolanz of Materion stated that one sample does not
provide "a good understanding of what's out there," and there is
"value in trying to collect at least a few samples" (Document ID
1755, Tr. 140). The Department of Defense (DOD) commented that it is
not appropriate to discontinue monitoring based on one sample below the
action level (Document ID 1684, Attachment 2, p. 3). The American
College of Occupational and Environmental Medicine (ACOEM) commented
that "[t]here is significant uncertainty associated with limited
sample numbers" (Document 1685, p. 3). Ameren Corporation (Ameren), an
electric utility company, stated that the number of samples needed
"depend[s] on how well the sample characterizes the work performed"
(Document ID 1675, p. 10). The Sampling and Analysis Subcommittee Task
Group of the Beryllium Health and Safety Committee (BHSC Task Group), a
non-profit organization promoting the understanding and prevention of
beryllium-induced conditions and illnesses, commented that it would not
consider a single sample to be a reasonable determination of exposures
(Document ID 1665, p. 6). North America's Building Trades Unions
(NABTU) commented that it was unreasonable to allow discontinuation of
monitoring based on one sample below the action level, because that
sample could be a statistical aberration, and "the assumption that if
a workplace is in compliance at one time it will stay in compliance in
the future is a fallacy, particularly on an active, dynamic
construction site" (Document ID 1679, p. 8). The USW and Materion
stated that exposure characterization often requires more than one
sample (Document ID 1680, p. 3). Southern Company suggested that
"language regarding initial and periodic monitoring, and the
discontinuation of both, [should] be consistent with existing substance
specific standards" (Document ID 1668, p. 3).
OSHA has considered these comments and has determined that if
initial monitoring indicates that employee exposures are below the
action level and at or below the STEL, no further monitoring is
required. Paragraph (d)(3)(iv) of the final standards permits employers
to discontinue monitoring of employees whose exposure is represented by
such monitoring where initial monitoring indicates that exposure is
below the action level and at or below the STEL. However, a single
sample below the action level and at or below the STEL does not
necessarily warrant discontinuation of exposure monitoring. OSHA has
clarified in final paragraphs (d)(3)(i) and (d)(3)(ii) that any initial
monitoring conducted under the scheduled monitoring option must reflect
exposures on each shift, for each job classification, and in each work
area. Therefore, where there is more than one shift or work area for a
particular task, there will be more than one sample; accordingly, it is
unlikely that an employer would be able to sufficiently characterize
and assess employee
exposure for a given job classification under the scheduled monitoring
option using a single sample.
In paragraph (d)(3) of the proposed rule, periodic exposure
monitoring was required at least annually if initial exposure
monitoring found exposures at or above the action level and at or below
the TWA PEL. In the NPRM, OSHA asked a question about the frequency of
monitoring and the reasoning behind that frequency. During the
hearings, Peggy Mroz with NJH testified that periodic monitoring
conducted at least every 180 days when exposures are at or above the
action level is "the most protective for workers" (Document ID 1756,
Tr. 99-100). Ms. Mroz further stated that exposure monitoring should
also be conducted at least annually for all other processes and jobs
where initial monitoring shows levels below the action level since
changes in working conditions can affect monitoring results, and "[i]t
has already been shown that beryllium sensitization and CBD occur at
measured exposures below the proposed action level" (Document ID 1756,
Tr. 100). Both NIOSH and NJH recommended more frequent monitoring for
employers to fully understand levels of exposure that may vary over
time and to assess whether proper controls are in place after a high
exposure level is documented (Document ID 1725, p. 29; 1720, p. 5). The
BHSC Task Group stated that annual monitoring is inadequate, and
recommended sampling more frequently than every 180 days (Document ID
1665, pp. 15, 17). And, the AFL-CIO commented that annual exposure
monitoring is inadequate and does not provide the employer with enough
information to make appropriate changes to prevent and minimize
exposure. The AFL-CIO cited various OSHA health standards that required
more frequent periodic exposure monitoring, including cadmium,
asbestos, vinyl chloride, arsenic, lead, and respirable crystalline
silica (Document ID 1809, pp. 1-2). In contrast, Ameren agreed with the
proposal's requirement to conduct monitoring annually if exposures are
at or above the action level, because the proposal already requires
additional monitoring when work conditions change (Document ID 1675, p.
4). And, the Edison Electric Institute (EEI) commented that beryllium
exposure in the electric utility industry occurs during maintenance
outages, "which more closely align with the annual re-sampling
requirements than the 180 [day] provisions in these alternatives"
(Document ID 1674, p. 14).
OSHA is persuaded by the commenters recommending more frequent
periodic monitoring and has changed the frequency required for
exposures between the action level and the TWA PEL in the scheduled
monitoring option in the final standards. Paragraph (d)(3)(v) of the
final standards requires monitoring every six months if initial
exposure monitoring indicates that exposures are at or above the action
level but at or below the TWA PEL, which is the typical frequency in
other health standards for carcinogens such as respirable crystalline
silica, cadmium, vinyl chloride, and asbestos for this level of
exposure. Alternatively, employers in general industry, construction,
and shipyards can use the performance option in paragraph (d)(2), which
provides employers greater flexibility to meet their exposure
assessment obligations.
In the proposal, OSHA did not require periodic exposure monitoring
if initial exposure monitoring indicated that exposures were above the
TWA PEL or STEL. In response to a question in the NPRM about monitoring
above the PEL, Materion commented that there is no benefit to expending
time and money monitoring exposures that exceed the PEL, because it is
more important that activities be directed toward the exposure control
plan. Based on their experience, Materion believes that employers will
conduct monitoring as often as necessary to demonstrate that exposures
have been reduce to below the PEL (Document ID 1661, p. 24 (pdf)).
Other commenters disagreed with OSHA's proposal not to require periodic
exposure monitoring above the PEL. The DOD commented that periodic
monitoring should also be performed when levels are above the PEL to
ensure respiratory protection is adequate and to test the effectiveness
of engineering controls (Document ID 1684, Attachment 2, p. 9). In
response to a question during the hearings on the benefits of
monitoring above the PEL, NIOSH's Dr. Virji testified that exposure can
vary within a job and that even though an employer may know exposures
are high in a particular area, the information is "useful because then
it allows an understanding of what level of engineering controls that
would be required to bring down the exposures to acceptable levels"
(Document ID 1755, Tr. 49-50). In her testimony, Mary Kathryn Fletcher
with the AFL-CIO expressed support for monitoring above the PEL,
stating that "exposure monitoring is important to reevaluate control
measures in cases of over-exposure," and "[it is] important to
characterize the job to know the exposures if you're going to try to
reduce those exposures" (Document ID 1756, Tr. 236). Also during the
hearings, Ashlee Fitch with the Health, Safety, and Environment
Department of the USW responded to a similar question on the benefits
of air monitoring in cases where exposures are believed to exceed the
PEL. She stated, "You see oftentimes that employers used exposure
rates to measure how well ventilation systems are working or what the
exposure is, and after they implement engineering controls, what that
exposure goes to" (Document ID 1756, Tr. 282). In her testimony, Peggy
Mroz with NJH expressed support for periodic exposure monitoring every
90 days where exposures exceed the TWA PEL or STEL as "routine and
regular sampling and repeated sampling should be done to assess whether
proper controls are in place after a high sample is documented as we
know that beryllium sensitization and chronic beryllium disease can
occur within a few weeks of exposure" (Document ID 1756, Tr. 100).
Based on these comments received in the record and testimony
obtained from the public hearing, OSHA's final standards require
periodic exposure monitoring every three months when exposures are
above the TWA PEL or STEL under the scheduled monitoring option in
paragraphs (d)(3)(vi) and (d)(3)(viii). Alternatively, employers in
general industry, construction, and shipyards can use the performance
option in paragraph (d)(2) which provides employers with greater
flexibility to meet their exposure assessment obligations.
Proposed paragraph (d) did not include a separate provision to
allow employers to discontinue monitoring if exposures were
subsequently reduced to below the action level, as demonstrated by
periodic monitoring. In the NPRM, OSHA solicited comment on the
reasonableness of discontinuing monitoring based on one sample below
the action level. As discussed more fully in the explanation of final
paragraph (d)(3)(iv), many commenters discussed the importance of
taking multiple samples to confirm exposures are below the action level
before allowing the discontinuation of monitoring. For example, ORCHSE
Strategies (ORCHSE) commented that allowing discontinuation of
monitoring based on one sample is not appropriate and that two
consecutive samples taken at least seven days apart, that show exposure
below the action level, should be required to allow monitoring to be
discontinued (Document ID 1691, Attachment 1, p. 3).
As stated in the explanation of final paragraph (d)(3)(iv), OSHA
has carefully considered these comments and agrees that a single sample
is not sufficient to allow employers to discontinue monitoring. OSHA
has therefore decided to add paragraph (d)(3)(vii) to the final
standards. This provision requires that, where the most recent exposure
monitoring indicates that employee exposure is below the action level,
the employer must repeat exposure monitoring within six months of the
most recent monitoring. The employer may discontinue TWA monitoring,
for those employees whose exposure is represented by such monitoring,
only when two consecutive measurements, taken seven or more days apart,
are below the action level, except as otherwise provided in the
reassessment of exposures requirements in paragraph (d)(4) of the final
standards. Additionally, OSHA has added paragraph (d)(3)(viii) to the
final standards. This provision requires that, where the most recent
exposure monitoring indicates that employee exposure is above the STEL,
the employer must repeat exposure monitoring within three months of the
most recent short-term exposure monitoring until two consecutive
measurements, taken seven or more days apart, are below the STEL. At
this point, the employer may discontinue monitoring for those employees
whose exposure is represented by such monitoring. As discussed below,
reassessment is always required whenever a change in the workplace may
be reasonably expected to result in new or additional exposures at or
above the action level or above the STEL or the employer has any reason
to believe that new or additional exposures at or above the action
level or above the STEL have occurred, regardless of whether the
employer has ceased monitoring because exposures are below the action
level or at or below the STEL under paragraphs (d)(3)(iv), (d)(3)(vii),
or (d)(3)(viii) of the final standards. Exposure assessment in
construction and shipyard industries. Beryllium exposure occurs in the
construction and shipyard industries primarily during abrasive blasting
operations that use coal and copper slags containing trace amounts of
beryllium (Document ID 1815, Attachment 85, pp. 70-72; 0767, p. 6).
During the public hearing, testimony was heard about abrasive
blasting operations using slags at a shipyard facility. Mike Wright,
with the USW, testified that the use of enclosure (containment) is
important to prevent the escape of beryllium dust during abrasive
blasting operations and that exposure monitoring could help determine
the integrity of the enclosure along with establishing a perimeter
where beryllium contamination is controlled (Document ID 1756, Tr. 274-
275). Ashlee Fitch, also representing the USW, testified about
monitoring worker exposure to beryllium in the maritime industry. Ms.
Fitch stated that abrasive blasting using beryllium-containing abrasive
materials should be done in full containment and that exposures outside
the containment should not exceed the PEL or STEL (Document ID 1756,
Tr. 244-245). Ms. Fitch recommended that in cases where full
containment is used, "the employer shall do an initial monitoring for
each configuration of the containment" and "if the initial monitoring
shows exposures above the action level, monitoring shall be performed
for every blasting operation." She also recommended air monitoring of
exposed workers outside of the containment or through monitoring of the
positions where exposure is likely to be the highest, or if full
containment is not used, "around any abrasive blasting operation"
(Document ID 1756, Tr. 245). Representative Robert Scott, the ranking
minority member on the Committee on Education and the Workforce of the
U.S. House of Representatives (Representative Scott), commented that
when workers are engaged in abrasive blasting and the abrasive blasting
area is contained, exposure monitoring should be routinely performed
when levels exceed the action level (Document ID 1672, p.4).
Substantially agreeing with these comments, in paragraph (d)(3) of
the final standards, OSHA is requiring monitoring on each work shift,
for each job classification, and in each work area when employers are
following the scheduled monitoring option. OSHA also agrees that
monitoring should be of the positions where exposure is likely to be
the highest, so when employers engage in representative sampling under
the scheduled monitoring option, final paragraph (d)(3)(iii) requires
that they must sample the employee(s) expected to have the highest
airborne exposure to beryllium. OSHA also agrees with Representative
Scott that exposure monitoring should be routinely performed for
abrasive blasting and all other operations exposing workers to
beryllium when exposures exceed the action level. If exposures exceed
the action level or STEL, the employer is required to monitor exposures
at frequencies indicated in the scheduled monitoring option or using
the performance option to accurately assess the beryllium exposure of
their employees. However, OSHA does not consider monitoring to be
necessary each time there is an abrasive blasting or other operation
that fits within the profile of a previously taken representative
sample.
Reassessment of exposures. Paragraph (d)(4) of the final standards,
like paragraph (d)(4) of the proposal, describes the employer's
obligation to reassess employee exposures under certain circumstances.
Proposed paragraphs (d)(4)(i) and (d)(4)(ii) required the employer to
conduct exposure monitoring within 30 days after a change in production
processes, equipment, materials, personnel, work practices, or control
methods that could reasonably be expected to result in new or
additional exposure, or if the employer had any other reason to believe
that new or additional exposure was occurring.
Commenters generally advocated for monitoring to assess any new
exposures. For example, in her testimony, Mary Kathryn Fletcher with
the AFL-CIO expressed support for exposure monitoring even if exposure
is reduced as far as feasible, because exposures can change, so "it's
important to monitor as tasks change and over time, there are different
procedures, different workers in the area, doing different things"
(Document ID 1756, Tr. 236). Also, NJH commented that "periodic
sampling, even of low exposure potential tasks, ensures that despite
changes in processes, personnel, exhaust systems, and other control
measures, the exposure remains low and workers remain safe" (Document
ID 1664, p. 6). Therefore, the Agency has decided to retain the
requirement of proposed paragraph (d)(4) that employers reassess
exposures, but has made minor changes to the regulatory text. OSHA has
changed the title "Additional Monitoring" in proposed paragraph
(d)(4) to "Reassessment of exposures" in paragraph (d)(4) of the
final standards to be consistent with the change in paragraph (d)
terminology from "exposure monitoring" to "exposure assessment."
OSHA has also changed the proposed requirement that employers conduct
exposure monitoring within 30 days after a change in "production
processes, equipment, materials, personnel, work practices, or control
methods" that could reasonably be expected to result in new or
additional exposures to the requirement in the final standards that
employers must perform reassessment of exposures
when there is a change in "production, process, control equipment,
personnel, or work practices" that may reasonably be expected to
result in new or additional exposures at or above the action level or
STEL. OSHA made these changes to provide clarity and consistency with
other OSHA health standards.
In addition, there may be other situations that can result in new
or additional exposures that are unique to an employer's work
situation. In order to cover those special situations, OSHA has
retained the requirement in proposed paragraph (d)(4)(ii) that the
employer must reassess exposures whenever the employer has any reason
to believe that a change has occurred that may result in new or
additional exposures, and has added "at or above the action level or
STEL" to final paragraph (d)(4). Under this provision, for example, an
employer is required to reassess exposures when an employee has a
confirmed positive result for beryllium sensitization, exhibits signs
or symptoms of CBD, or is diagnosed with CBD. These conditions
necessitate a reassessment of exposures to ascertain if airborne
exposures contributed to the beryllium-related health effects.
Additionally, reassessment of exposures would be required following a
process modification that increases the amount of beryllium-containing
material used, thereby possibly increasing employee exposure.
Reassessment of exposures will also be required when a shipyard or
construction employer introduces a new beryllium-containing slag for
use in an abrasive blasting operation. Once reassessment of exposures
is performed and if exposures are above the action level, TWA PEL, or
STEL, the employer can take appropriate action to protect exposed
employees and must perform periodic monitoring as discussed above.
Methods of sample analysis. Paragraph (d)(5) of the final
standards, like proposed paragraph (d)(1)(v), addresses methods for
evaluating air monitoring samples. Proposed paragraph (d)(1)(v)
required employers to use a method of exposure monitoring and analysis
that could measure beryllium to an accuracy of plus or minus 25 percent
within a statistical confidence level of 95 percent for airborne
concentrations at or above the action level. This provision is largely
unchanged in the final standards. OSHA has changed the title "Accuracy
of measurement" in the proposal's paragraph (d)(1)(v) to "Methods of
sample analysis" in paragraph (d)(5) of the final standards. OSHA made
this change to more accurately describe the purpose of this
requirement. Additionally, OSHA changed the requirement that employers
"use a method of exposure monitoring and analysis" in the proposed
rule to require that employers "ensure that all samples taken to
satisfy the monitoring requirements of paragraph (d) are evaluated by a
laboratory" to clarify that employers may send samples to a laboratory
for analysis, and OSHA does not intend to require employers to have a
laboratory to analyze samples at the worksite.
Under final paragraph (d)(5), the employer is required to make sure
that all samples taken to satisfy the monitoring requirements of
paragraph (d) are evaluated by a laboratory that can measure airborne
levels of beryllium to an accuracy of plus or minus 25 percent within a
statistical confidence level of 95 percent for airborne concentrations
at or above the action level. The following methods meet these
criteria: NIOSH 7704 (also ASTM D7202), ASTM D7439, OSHA 206, OSHA
125G, and OSHA 125G using ICP-MS. All of these methods are available to
commercial laboratories analyzing beryllium samples. However, not all
of these methods are appropriate for measuring beryllium oxide, so
employers must verify that the analytical method used is appropriate
for measuring the form(s) of beryllium present in the workplace.
In the NPRM, OSHA requested comment on whether these methods would
satisfy the requirements of this paragraph, and if there were other
methods that would also meet these criteria. The BHSC Task Group
commented that OSHA's accuracy criteria could be met for full shift
samples using available analytical methods. The BHSC Task Group agreed
with the guidance in OSHA's NPRM to use ICP-MS or fluorescence to
assure adequate sensitivity and analytical precision (Document ID 1655,
p. 2). In response to a question on whether the current methods were
sufficiently sensitive, Kevin Ashley with NIOSH testified that both the
fluorescence method (NIOSH method 7704) and the inductively coupled
plasma mass spectrometry (ASTM method D7439) were adequately sensitive
to measure at the proposed PEL and STEL (Document ID 1755, Tr. 58). The
DOD commented that the current limit of quantification (LOQ) of 0.05
µg for beryllium using the NIOSH 7300 and OSHA 125G methods would
be adequate to detect exposures below the proposed action level of 0.1
µg/m3\ and the proposed STEL of 2 µg/m3\ (Document ID
1684, Attachment 2, p. 9). OSHA has identified several sampling and
analysis methods for beryllium that are capable of detecting beryllium
at air concentrations below the final action level of 0.1 µg/m3\
and the final STEL of 2.0 µg/m3\ for a 15-minute sampling period
(see Chapter IV of the Final Economic Analysis, Technological
Feasibility). Therefore, OSHA has determined that the sampling and
analytical methods currently available to employers are sufficient to
measure beryllium as required in paragraph (d) of the final standards.
Rather than specifying a particular method that must be used, the
final standards allow for a performance-oriented approach that allows
the employer to use the method and analytical laboratory of its
choosing as long as that method meets the accuracy specifications in
paragraph (d)(5) and the reported results represent the total airborne
concentration of beryllium for the worker being characterized. Other
methods, such as a respirable fraction sample or size selective sample,
would not provide results directly comparable to either PEL, and
therefore would not be considered valid.
Employee Notification of Assessment Results. Paragraph (d)(6) of
the final standards, like proposed paragraph (d)(5), addresses employee
notification requirements. OSHA did not receive comment specifically on
this provision, but several commenters supported the exposure
monitoring provisions as a whole, and after reviewing the record, OSHA
has decided to retain the employee notification requirements in the
final standards. OSHA has changed the title "Employee Notification of
Monitoring Results" in proposed paragraph (d)(5) to "Employee
Notification of Assessment Results" in final paragraph (d)(6) to
reflect the change in the title of paragraph (d). This requirement is
consistent with other OSHA standards, such as those for respirable
crystalline silica (29 CFR 1910.1053), methylenedianiline (29 CFR
1910.1050), 1,3-butadiene (29 CFR 1910.1051), and methylene chloride
(29 CFR 1910.1052).
Proposed paragraph (d)(5)(i) required employers to notify each
employee of his or her monitoring results within 15 working days after
receiving the results of any exposure monitoring. Both the employees
whose exposures were measured directly and those whose exposures were
represented by the monitoring had to be notified. The employer had to
notify each employee individually in writing or post the monitoring
results in an appropriate location accessible to all employees required
to be notified. Proposed paragraph (d)(5)(i) is now paragraph (d)(6)(i)
in the final standards, and has
been edited to reflect the change in language from "exposure
monitoring" to "exposure assessment," discussed earlier. This can be
in print or electronically as long as the affected employees have
access to the information and have been informed of the posting
location. Final paragraph (d)(6)(i) for general industry, construction,
and shipyards is substantively unchanged from the proposal. However,
due to the transient nature of construction work and the need to
receive exposure assessment results while the work is still occurring,
OSHA recommends that employers in the construction industry make every
effort to notify employees of their monitoring results as soon as
possible.
Proposed paragraph (d)(5)(ii) required that, whenever exposures
exceeded the TWA PEL or STEL, the written notification required by
proposed paragraph (d)(5)(i) include (1) suspected or known sources of
exposure and (2) a description of the corrective action(s) that have
been taken or will be taken by the employer to reduce the employee's
exposure to or below the TWA PEL or STEL where feasible corrective
action exists but was not implemented at the time of the monitoring.
OSHA did not receive comment on this specific provision, and after
reviewing the record, including comments supporting paragraph (d)
generally, OSHA has decided to retain a notification requirement
focused on individual exposure assessments and the corrective actions
being taken for exposures above the PEL or STEL. It is necessary to
assure employees that the employer is making efforts to furnish them
with a safe and healthful work environment, and to provide employees
with information about their exposures. Furthermore, notification to
employees of exposures above a prescribed PEL and the corrective
actions being taken is required under section 8(c)(3) of the Act (29
U.S.C. 657(c)(3)). In order to provide consistency with other OSHA
health standards, OSHA has removed the requirement in proposed
paragraph (d)(5)(ii) that employers include suspected or known sources
of exposure in the written notification. Proposed paragraph (d)(5)(ii),
as revised, is now paragraph (d)(6)(ii) in the final standards.
Observation of monitoring. Paragraph (d)(7) of the final standards,
like proposed paragraph (d)(6), requires employers to provide for
observation of exposure monitoring. OSHA did not receive comment on
this specific provision, and after reviewing the record, including
comments supporting paragraph (d) generally, OSHA has decided to retain
it in the final standards because it promotes occupational safety and
health and is required by the OSH Act. Section 8(c)(3) of the Act (29
U.S.C. 657(c)(3)) mandates that regulations requiring employers to keep
records of employee exposures to toxic materials or harmful physical
agents provide employees or their representatives with the opportunity
to observe monitoring or measurements.
Proposed paragraph (d)(6)(i) required the employer to provide an
opportunity to observe any exposure monitoring required by the
standards to each employee whose airborne exposure was measured or
represented by the monitoring and to each employee's representative(s).
Proposed paragraph (d)(6)(i) is now paragraph (d)(7)(i) in the final
standards, and is substantively unchanged from the proposal. When
observation of monitoring required entry into an area where the use of
protective clothing or equipment was required, proposed paragraph
(d)(6)(ii) required the employer to provide the observer with that
personal protective clothing or equipment, at no cost. The employer was
also required to ensure that the observer used such clothing or
equipment appropriately. Proposed paragraph (d)(6)(ii) is now paragraph
(d)(7)(ii) in the final standards, and is substantively unchanged from
the proposal. Paragraph (d)(6)(iii) of the proposal required employers
to ensure that each observer complied with all applicable OSHA
requirements and the employer's workplace safety and health procedures.
Proposed paragraph (d)(6)(iii) is now paragraph (d)(7)(iii) in the
final standards. OSHA has changed the proposed language to require that
employers ensure that each observer follows all other applicable safety
and health procedures to clarify that the burden to comply with OSHA
requirements remains on the employer, not the observer.
(e) Beryllium Work Areas and Regulated Areas (General Industry);
Regulated Areas (Shipyards); and Competent Person (Construction)
Paragraph (e) of the standards for general industry and shipyards
sets forth the requirements for establishing, maintaining, demarcating,
and limiting access to certain areas of the workplace to aid in
minimizing employee exposure to beryllium. As discussed below, the
general industry standard includes requirements for both "work areas"
and "regulated areas," which are subsets of work areas. The shipyard
standard includes requirements for regulated areas, but not work areas.
Paragraph (e) of the construction standard does not require either work
areas or regulated areas, but instead includes requirements for a
"competent person," who has responsibility for demarcating certain
areas of beryllium exposure for similar purposes.
Specifically, paragraph (e)(1)(i) and (e)(2)(i) of the standard for
general industry requires employers to establish, maintain, and
demarcate one or more "beryllium work area," which is defined as a
work area containing a process or operation that can release beryllium
where employees are, or can reasonably be expected to be, exposed to
airborne beryllium at any level or where there is the potential for
dermal contact with beryllium. OSHA intends these beryllium work area
provisions to apply to the area surrounding the process, operation, or
task where airborne beryllium is released or the potential for dermal
contact is created. Beryllium work areas are also referenced in the
general industry standard in paragraphs (f)(1) (the written exposure
control plan), (f)(2) (engineering and work practice controls), and (j)
(housekeeping). Under paragraphs (e)(1)(ii) and (e)(1) of the standards
for general industry and shipyards, respectively, employers are also
required to establish and maintain regulated areas wherever employees
are, or can reasonably be expected to be, exposed to airborne beryllium
at levels above the TWA PEL or STEL. As indicated and discussed in more
detail below, the final standards for shipyards and construction do not
contain provisions for beryllium work areas and the standard for
construction does not require employers to establish regulated areas.
In lieu of regulated areas, paragraph (e) of the final standard for
construction, Competent Person, consists of a set of requirements
designed to provide most of the same protections as regulated areas in
general industry and shipyards, using a competent person instead of
demarcated areas to achieve these ends.
The requirements to establish beryllium work areas and regulated
areas or designate competent persons serve several important purposes.
First, requiring employers to establish and demarcate beryllium work
areas in general industry ensures that workers and other persons are
aware of the potential for work processes to release airborne beryllium
or cause dermal contact with beryllium. Second, the required
demarcation of regulated areas in general industry and shipyards in
accordance with the paragraph (m) requirements for warning signs
ensures that all persons entering regulated areas
will be aware of the serious health effects associated with exposure to
beryllium. Similarly, assignment of a competent person to carry out the
provisions of paragraph (e) in the construction standard where
exposures may exceed the TWA PEL or STEL provides employees in
construction with a knowledgeable on-site authority to convey
information about the hazards of beryllium exposure. Third, limiting
access to regulated areas (general industry and shipyards) or areas
where exposures may exceed the TWA PEL or STEL (construction) restricts
the number of workers potentially exposed to beryllium at levels above
the TWA PEL or STEL. Finally, provisions for respiratory protection and
PPE ensure that those who must enter regulated areas (general industry
and shipyards) or areas where exposures may exceed the TWA PEL or STEL
(construction) are properly protected, thereby reducing the risk of
serious health effects associated with airborne beryllium exposure and
dermal contact with beryllium.
The remainder of this section provides detailed discussion of each
provision in paragraph (e) of the final standards for general industry,
shipyards, and construction, as well as comments OSHA received on
paragraph (e) of the proposed standard, OSHA's response to these
comments, and the reasons for OSHA's decisions regarding the provisions
of paragraph (e) in each final standard.
Beryllium Work Areas (General Industry). Provisions for the
establishment of beryllium work areas were included in the proposed
standard for general industry in paragraph (e)(1)(i). This proposed
provision required employers to establish and maintain beryllium work
areas where employees are, or can reasonably be expected to be, exposed
to airborne beryllium. OSHA explained that it intended the provision to
apply to all areas and situations where employees are actually exposed
to airborne beryllium and to areas and situations where the employer
has reason to anticipate or believe that airborne exposures may occur.
The Agency further explained that--unlike the requirements for
regulated areas--the proposed requirements were not tied to a
particular level of exposure, but rather were triggered by the presence
of airborne beryllium at any exposure level. The provision was based on
a provision recommended by Materion Corporation (Materion) and the
United Steelworkers (USW) in their joint submission, (see previous
discussion in the Introduction to this Summary and Explanation
section).
A number of stakeholders commented on the proposed definition of a
beryllium work area. Some commenters, such as NGK Metals Corporation
(NGK) and ORCHSE Strategies (ORCHSE), argued that the definition of a
beryllium work area is vague and requested that OSHA trigger the
requirement to establish and maintain beryllium work areas at a
measureable threshold, such as the action level (e.g., Document ID
1663, p. 1; 1691, Attachment 1, p. 15). Edison Electric Institute
(EEI), an industry association representing electric utility companies,
also did not agree with the beryllium work area definition (Document ID
1674, p. 13). Like NGK and ORCHSE, EEI recommended that OSHA tie the
beryllium work area requirements to a quantifiable exposure level, like
the action level or the PEL (Document ID 1674, p. 13). The Boeing
Company (Boeing) also recommended the use of a quantifiable trigger,
but suggested a much lower trigger of 0.02 µg/m3\ (Document ID
1667, p. 3). Boeing explained that not including a specific threshold
can lead to inconsistent results because it depends on the sensitivity
of the measurement method (Document ID 1667, p. 3).
Other commenters supported the proposed standard's establishment of
beryllium work areas at any level of airborne beryllium exposure. For
example, AWE commented that its "supervised beryllium workspaces"
align with the proposal's beryllium work areas (Document ID 1615, p.
1). NIOSH observed that the proposed approach is feasible and
appropriate for beryllium work settings where work such as production,
processing, handling, and manufacturing of beryllium products is
performed and areas where needed preventive controls can be relatively
easily demarcated (Document ID 1725, pp. 29-30). Materion and USW
reiterated their support for provisions related to beryllium work areas
"where operations generate airborne beryllium particulate", which
were included in the recommended model standard they submitted to OSHA
(Document ID 1680, p. 3).
The purpose of a beryllium work area is to establish a demarcated
area in which workers and other persons authorized to be in the area
are made aware of the potential for beryllium exposure and must take
certain precautions accordingly. OSHA finds that establishing beryllium
work areas where exposures are at the action level or above the PEL
would not adequately protect exposed workers operating outside
demarcated regulated areas, for which the applicable trigger is the TWA
PEL or STEL. Because, as discussed in Section V, Health Effects, there
is still a potential health risk to workers exposed to beryllium below
the action level, the establishment and demarcation of beryllium work
areas at any level of airborne exposure will provide additional
protection for these workers by ensuring that they are aware of the
presence of processes that release beryllium. OSHA similarly finds that
Boeing's suggested trigger of 0.02 µg/m3\ is not suitable
because OSHA has not established a level of exposure at which beryllium
does not pose a risk to workers (see this preamble at Section VI, Risk
Assessment). Therefore, OSHA finds that establishing and demarcating
beryllium work areas wherever processes or operations release beryllium
is more protective. OSHA also does not agree with those commenters who
find the trigger for establishing beryllium work areas vague. As
explained previously, OSHA has modified the beryllium work areas
provision in the final standard for general industry to specify that
the source of the airborne beryllium exposure and potential for dermal
contact triggering the requirement for a beryllium work area must be
generated from a process or operation within that area, not just the
fact that an employee may be handling an article containing beryllium.
An employer can (but is not required to) use air monitoring to
determine the presence of airborne beryllium in the area surrounding
the process, operation, or task that may be releasing beryllium or wipe
sampling to determine the presence of beryllium on surfaces that
workers may come into contact with. Affording the employer such
flexibility to comply with this performance-based provision does not
make it impermissibly vague. Accordingly, OSHA has decided to retain,
as modified, the requirement that beryllium work areas must be
established and maintained where there is a process or operation that
can release beryllium and employees are, or can reasonably be expected
to be, exposed to airborne beryllium at any level. However, as
discussed below, OSHA has somewhat modified the definition of beryllium
work areas in response to comments from other stakeholders and NIOSH.
Two electric utility companies, Southern Company and Ameren
Corporation (Ameren), argued that a work area requirement defined by
any level of airborne beryllium exposure was subjective and would
result in their entire facility falling under this
requirement (Document ID 1668, pp. 3-4; 1675 p. 5). The Aluminum
Association stated that there may be areas where airborne beryllium
exposures are present but have been found through exposure assessments
and monitoring to be insignificant; therefore, beryllium work areas are
overly broad as defined in the proposal and should be dropped from the
final standard (Document ID 1666, p. 2). The American College of
Occupational and Environmental Medicine (ACOEM) also did not agree with
the proposed definition of beryllium work areas because it is not
specific to workplaces where beryllium is used or processed (Document
ID 1685, p. 2). ACOEM argued that airborne beryllium is essentially
ubiquitous at very low levels, and that the proposed definition of
beryllium work areas could be interpreted to apply to most worksites
regardless of work activity. Therefore, ACOEM suggested clarifying the
requirement using language that specifies "worksites in which any
beryllium or beryllium-containing materials are or have been processed
using methods capable of generating dust or fume" (Document ID 1685,
p. 2).
OSHA did not intend a scenario where an entire facility becomes a
beryllium work area from environmental or other non-occupational
sources of beryllium. Nor did the Agency intend to cause the entirety
of any worksite covered by the rule to become a beryllium work area,
even where the amount of airborne beryllium is insignificant in the
sense that it is residually present at very low levels in areas of a
facility where work processes that release airborne beryllium do not
occur. (Note that the best available scientific evidence has not
identified a medically insignificant level of beryllium exposure; as
discussed in Section VI, Risk Assessment, beryllium sensitization has
been found among individuals whose exposures are below the action
level.) Such a situation might occur in a coal-fired electric
generating plant or a foundry where a very small amount of beryllium
may be detectable far away from the processes that released it. To
avoid these unintended consequences, OSHA has modified the beryllium
work areas provision in the final standard for general industry to
specify that the source of the airborne beryllium exposure and
potential for dermal contact triggering the requirement for a beryllium
work area must be generated from a process or operation within that
area. This modification is similar to ACOEM's suggestion to define
beryllium work areas as areas where beryllium or beryllium-containing
materials are or have been processed (Document ID 1685, p. 2). While
the trigger for beryllium work area is based on whether the beryllium
is processed by controlling the release of airborne beryllium from the
particular process, operation, or task, the employer can limit the size
of the beryllium work area and eliminate the likelihood of an entire
facility becoming a beryllium work area. OSHA believes this modified
definition of beryllium work areas addresses the concerns raised by
employers and ACOEM, while also maintaining the protective benefits
associated with beryllium work areas for beryllium-exposed employees.
In addition to commenting on the level of exposure that should
trigger the establishment and maintenance of a beryllium work area,
NIOSH offered an opinion on the type of exposure that should trigger
beryllium work areas. Specifically, NIOSH argued that limiting the
definition of beryllium work area to employee exposure to airborne
beryllium omits the potential contribution of dermal exposure to total
exposure (Document ID 1725, p. 30). To support its point, NIOSH cited
to Armstrong et al. (2014), which reported that work processes
associated with elevated risk for beryllium sensitization had high air/
high dermal exposure, high air/low dermal exposure, or low air/high
dermal exposure indicating that dermal exposures should be considered
as relevant pathways (Document ID 1725, p. 30). OSHA agrees with NIOSH
and has modified the beryllium work areas section of the final standard
for general industry to include potential dermal exposure.
OSHA also made two other minor, nonsubstantive changes to the
proposed provision to help streamline the final general industry
standard. First, instead of restating the definition of beryllium work
area in paragraph (e)(1)(i) (as in the proposal), OSHA has modified
final paragraph (e)(1)(i) in the proposal to merely refer to the term
as defined in paragraph (b) of the standard for general industry.
Second, the definition of beryllium work area in the final general
industry standard includes the qualifier "where employees are, or can
reasonably be expected to be, exposed to airborne beryllium at any
level." This is a modification from the proposed beryllium work area
definition wording "where employees are, or can reasonably be expected
to be, exposed to airborne beryllium, regardless of the level of
exposure." Both of these changes were intended only to simplify the
language of the regulatory text and should not be read to suggest a
change in substantive requirements or the Agency's intent.
The construction and shipyard sectors were not included in the
proposed standard. However, OSHA requested comments on Regulatory
Alternative #2a in the NPRM, which would apply all provisions of the
proposed standard to facilities in construction and shipyards,
including provisions pertaining to the establishment of beryllium work
areas. Following careful consideration of the comments OSHA received
from a variety of stakeholders and from NIOSH on this topic, OSHA has
concluded that the requirement to establish and maintain beryllium work
areas are not appropriate for construction or shipyards. The work
processes (primarily abrasive blasting), worksites, and conditions in
construction and shipyards differ substantially from those typically
found in general industry; as discussed further below, establishment of
beryllium work areas in these sectors is likely to be impractical.
However, OSHA has modified the standards so that most of the protective
measures related to beryllium work areas in the general industry
standard apply to operations in construction and shipyards, using
triggers more suitable for these sectors. Thus, OSHA believes the final
standards for construction and shipyards provide employees protection
similar to employees in general industry, but avoid the difficulties
associated with establishment of beryllium work areas in the context of
abrasive blasting operations in these sectors.
NIOSH commented that while it supported triggering the requirement
to establish beryllium work areas at any level of airborne exposures,
it is not clear how such a requirement would work in an outdoor
environment (Document ID 1725, p. 30). It explained that it is possible
that even ambient conditions could cause an outdoor work environment to
qualify as a "beryllium work area" (Document ID 1725, p. 30). NIOSH
also noted that it was unclear how to delineate beryllium work areas in
an outdoor setting when abrasive blasting the outer hull of a large
ship and questioned how the beryllium work area trigger of any level of
airborne exposure to beryllium could be applied only to that specified
area (Document 1755, Tr. 21). NIOSH further explained that establishing
a beryllium work area for abrasive blasting in an outdoor environment
is difficult because outdoor blasting operations often involve large
structures and constant moving of the operation (Document ID 1755, Tr.
55).
Newport News Shipbuilding (NNS) similarly commented that since
beryllium is primarily encountered in shipyards as a trace element in
coal slag blasting media, the requirement to establish and maintain
beryllium work areas is not appropriate for shipyards. NNS stated,
"[i]t is relatively easy to control a work area to a stated number
such as a permissible exposure limit or an action level, but
controlling `regardless of level of exposure' for a trace contaminant
in dust is impractical" (Document ID 1657, pp. 1-2).
Recognizing the difficulties described by NIOSH and NNS, the Agency
decided not to require employers in construction and shipyards to
establish and maintain beryllium work areas. However, OSHA has modified
provisions associated with beryllium work areas in paragraph (f)(1) and
paragraph (h) of the proposed standard so as to provide employees in
all sectors with largely equivalent protective measures. For example,
employers in all sectors are required to create, implement, and
maintain a written exposure control plan that lists jobs and operations
where beryllium exposure may occur, and that documents procedures for
limiting cross-contamination and migration of beryllium (see Summary
and Explanation of paragraph (f)(1)). Similarly, whereas employers in
general industry are required under paragraph (f)(2) to take certain
steps to reduce airborne beryllium in beryllium work areas where
exposures meet or exceed the action level, employers in construction
and shipyards have a nearly identical requirement to take steps to
reduce exposures where exposures meet or exceed the action level. Thus,
the only provisions related to beryllium work areas that apply in
general industry but not in construction and shipyards are those OSHA
is persuaded add protective value in general industry but would be
unworkable or ineffective in the construction and shipyard contexts of
abrasive blasting and outdoor operations, e.g., certain housekeeping
provisions related to surface contamination (see Summary and
Explanation, paragraph (j), Housekeeping, for further discussion).
Regulated Areas. Paragraph (e)(1)(ii) of the proposed standard
required employers to establish and maintain regulated areas wherever
employees are, or can reasonably be expected to be, exposed to airborne
concentrations of beryllium in excess of the TWA PEL or STEL. OSHA
explained that the requirement to establish and maintain regulated
areas would apply if any exposure monitoring or objective data indicate
that airborne exposures are in excess of either the TWA PEL or STEL, or
if the employer has reason to anticipate or believe that airborne
exposures may be above the TWA PEL or STEL, even if the employer has
not yet characterized or monitored those exposures. For example, if
newly introduced processes involving beryllium appear to be creating
dust and have not yet been monitored, the employer should reasonably
anticipate that airborne exposures could exceed the TWA PEL or STEL. In
this situation, the employer would be required to designate the area as
a regulated area to protect workers and other persons until monitoring
results establish that exposures are at or below the TWA PEL and STEL.
In the proposed standard, work in regulated areas triggered additional
requirements for medical surveillance (see Summary and Explanation for
paragraph (k)), PPE (see Summary and Explanation for paragraph (h)),
and hazard communication (see Summary and Explanation for paragraph
(m)). The construction and shipyard sectors were not included in the
proposed standard, but were included in Regulatory Alternative #2a in
the NPRM, which would extend all provisions of the proposed standard
for general industry to construction and shipyards, including
provisions pertaining to regulated areas. OSHA requested comments on
this proposed regulatory alternative.
OSHA received relatively few comments on the proposed provisions
for regulated areas, which were largely similar to the regulated areas
provisions included in previous substance-specific standards. In
general, commenters did not oppose the concept of regulated areas.
Clive LeGresly with AWE noted that their organization establishes
"Controlled" beryllium workspaces that align with the final
standards' regulated areas (Document ID 1615, p. 4). However, some
commenters suggested modifications to OSHA's proposed definition of
regulated areas. In their comments, the Sampling and Analysis
Subcommittee Task Group of the Beryllium Health and Safety Committee
(BHSC Task Group) and National Jewish Health (NJH) both supported the
concept of regulated areas but recommended they be established when
exposures are at or above the action level (Document ID 1655, p. 7;
1664, p. 3). Finally, the Department of Defense (DoD) argued that
having both beryllium work areas and regulated areas was confusing and
burdensome, and suggested that the final standard should include only
areas with airborne beryllium above the TWA PEL or STEL, which they
described as better defined and more enforceable than the provisions
for beryllium work areas in the proposed standard (Document ID 1684,
Attachment 2, p. 2). After carefully considering the record on
regulated areas, OSHA has decided to modify some of the provisions
associated with regulated areas to address commenters' concerns where
appropriate, but to retain paragraph (e)(1)(ii) as proposed in the
final standard for general industry. Thus, final paragraph (e)(1)(ii)
in general industry requires employers to establish and maintain a
regulated area wherever employees are, or can reasonably be expected to
be, exposed to airborne beryllium at levels above the TWA PEL or STEL.
A detailed discussion of OSHA's decisions and reasoning follows.
As applied to general industry, OSHA has not accepted the DoD's
suggestion that only work areas where exposures exceed the TWA PEL or
STEL need to be demarcated as limited-access or regulated areas.
Because employees who are exposed to airborne beryllium below the TWA
PEL and STEL and who have dermal contact with beryllium are at risk of
adverse health effects, OSHA finds that it is appropriate to establish
and demarcate beryllium work areas wherever work processes create such
exposures and are primarily located in indoor settings, as OSHA finds
is typical of operations in general industry. As discussed above, the
requirement for the establishment and maintenance of beryllium work
areas is necessary to alert workers to the presence of beryllium and to
trigger basic exposure prevention methods, such as hygiene facilities
and housekeeping. However, it is also appropriate to establish
regulated areas with more stringent requirements, such as respiratory
protection, limited access, and warning signs, where exposures may
exceed the TWA PEL or STEL. OSHA concludes that beryllium work areas
and regulated areas serve distinct purposes, and each provides
important protections to employees. Therefore, OSHA has decided to
retain both beryllium work areas and regulated areas in the final
standard for the general industry standard. As explained elsewhere in
this section, OSHA finds that requirements to establish and demarcate
beryllium work areas are not appropriate to operations in construction
and shipyards, and that the objectives of regulated areas are better
achieved through the use of a competent person in construction.
OSHA has also carefully considered the recommendation by the BHSC
Task Group and NJH to use the action level rather than the TWA PEL or
STEL to trigger the provisions of the proposed standard associated with
regulated areas, and finds that it has some merit. For example, in the
proposed standard, employees who work in regulated areas for more than
30 days in a 12-month period would be eligible for medical
surveillance. Because employees exposed to beryllium at levels below
the TWA PEL are at significant risk of material impairment of health as
a result of their exposure (Section VII, Significance of Risk), OSHA is
persuaded that the action level is a more appropriate trigger for the
provision of medical surveillance. Eligibility for medical surveillance
at the action level is also consistent with previous OSHA standards
where significant risk remains at the TWA PEL, such as the recently
published respirable crystalline silica standard. In addition, because
beryllium sensitization can occur from dermal contact with beryllium
regardless of whether airborne exposures are above or below the TWA PEL
or STEL, OSHA believes it is appropriate to apply PPE requirements much
more broadly than the proposed standard, which relied heavily on work
in regulated areas as a trigger for PPE.
However, OSHA does not believe that all provisions associated with
regulated areas should apply at exposure levels below the TWA PEL and
STEL. Employers are required to restrict access to regulated areas,
thereby limiting the number of employees potentially exposed to
beryllium at levels above the TWA PEL or STEL and limiting others' risk
of serious health effects associated with such exposure. OSHA finds
that lowering the exposure trigger for regulated areas could lead to
the creation of large restricted areas, and therefore large numbers of
employees with access to restricted areas where exposures may range
anywhere between the action level and high above the final PEL. And, as
discussed previously, establishing and demarcating regulated areas
ensures that workers and other persons are aware of the potential
presence of airborne beryllium at levels above the TWA PEL or STEL and
ensures that all persons entering regulated areas are made aware of the
dangers of exposure to beryllium at these levels. Moreover, in general
industry, the requirement to demarcate beryllium work areas triggered
by any level of beryllium exposure resulting from a process or
operation, provides awareness for the potential hazard of beryllium
contact or exposure at levels below the action level. For these
reasons, OSHA believes that it is appropriate to retain the proposed
standard's definition of regulated areas and related provisions for
restricted access and demarcation.
In addition, OSHA finds that it is inappropriate to extend
mandatory provision and use of respirators (triggered by work in
regulated areas in the proposed standard) to all workers whose
exposures meet or exceed the action level. As discussed elsewhere in
this Summary and Explanation, OSHA's longstanding policy is to avoid
issuing standards that result in widespread use of respiratory
protection due to issues of health, safety, and effectiveness that can
occur with employees' regular use of respirators (see Summary and
Explanation for paragraph (f), Methods of Compliance, and paragraph
(g), Respiratory Protection).
For the reasons described above, OSHA has decided to adopt more
protective triggers for some of the provisions associated with
regulated areas in the proposed standard. OSHA has expanded eligibility
for medical surveillance to employees who work for at least 30 days in
a 12-month period in operations where airborne beryllium exposures meet
or exceed the action level (previously, employees who work for at least
30 days in a 12-month period in a regulated area; see Summary and
Explanation for paragraph (k), Medical Surveillance). OSHA has also
expanded PPE requirements to all employees whose work involves dermal
contact with beryllium (see Summary and Explanation for paragraph (h),
PPE). These expanded PPE requirements in recognition of the dermal risk
posed by beryllium also are responsive to a request from Public Citizen
that beryllium work areas and regulated areas be broadly defined in
order to ensure "appropriate protections against dermal exposure to
beryllium, and dermal sensitization" (Document ID 1756, Tr. 176-77).
As discussed in the Summary and Explanation of paragraph (a), Scope
and application, OSHA received comments from a variety of stakeholders
on Regulatory Alternative #2a presented in the NPRM, which extends all
provisions of the proposed standard to the construction and shipyard
sectors. Following careful consideration of these comments, OSHA
determined that it is appropriate to extend all provisions of the
proposed standard to cover facilities in construction and shipyards,
except where some provisions of the general industry standard may be
inappropriate due to the nature of workplaces or work processes in
construction or shipyards. OSHA has additionally reviewed comments
received on the topic of regulated areas in construction and shipyards,
to determine whether it is appropriate to modify the requirements for
regulated areas in these sectors. Based on its review, as well as
OSHA's previous experience regulating chemical exposures in these
sectors, the Agency has concluded that provisions for regulated areas
(as opposed to the larger beryllium work areas) are appropriate to
include in the final standard for shipyards. In construction, OSHA does
not find regulated area requirements to be appropriate but has decided
instead to require employers to meet the goals of the regulated areas
provisions using a competent person approach, which the Agency believes
will be more effective in construction work settings. OSHA's review of
the record and reasons for these decisions follow.
In the NPRM, OSHA requested comment on whether the provisions of
the abrasive blasting substandard in the Ventilation standard for
construction (29 CFR 1926.57, paragraph (f)) and the standard for
Mechanical paint removers in shipyards (29 CFR 1915.34(c)) provide
adequate protection to employees exposed to beryllium from abrasive
blasting operations in these sectors. As discussed previously in the
Summary and Explanation for paragraph (a), Scope and application,
commenters argued persuasively that these abrasive blasting standards
do not adequately protect beryllium-exposed construction and shipyard
employees, and that OSHA should extend all provisions of the general
industry standard to these sectors (e.g., Document ID 1679; 1963).
However, the Abrasive Blasting Manufacturers Alliance (ABMA) stated
that the proposed provisions for regulated areas in general industry
would be inconsistent with regulations for abrasive blasting in
shipyards, which do not always require such designated areas (Document
ID 1673, p. 22). A similar concern could apply to requirements for
regulated areas in construction.
In OSHA's view, the provisions of the abrasive blasting standards
in shipyards and in construction provide important baseline
requirements appropriate to any situation where abrasive blasting is
conducted in these sectors. However, the abrasive blasting standards
are not intended to provide comprehensive requirements for all abrasive
blasting operations, because some operations may involve hazards unique
to the particular process or blast media in use.
Operations that use beryllium-containing blast media present unique
risks of beryllium sensitization and CBD to exposed employees (see
Section V, Health Effects), and thus require protective measures beyond
those of the abrasive blasting standards. As discussed above, regulated
areas and related provisions include requirements that are key to
protecting employees from the effects of beryllium exposure, such as
restricted access, respiratory protection, and warning signs. OSHA
concludes that provisions similar to the requirements for regulated
areas in the final standard for general industry will provide shipyard
employees necessary protection complementing that found in the shipyard
mechanical paint remover standard, and is not in conflict with the
provisions or intent of that standard.
OSHA has similarly concluded that the beryllium standard should
apply to construction because it will better protect employees exposed
to beryllium while abrasive blasting than application of the
Ventilation standard alone. However, comments in the record and OSHA's
experience regulating chemical exposures in construction indicate that
the establishment of regulated areas is not the most effective way to
ensure that construction employees receive the protections associated
with regulated areas in the general industry standard. This decision is
chiefly based on the Agency's recognition that conditions at
construction worksites present challenges to establishing regulated
areas due to the varied and changing nature of construction work. Some
of these challenges were noted in the preamble to the recent respirable
crystalline silica standard (81 FR 16285) and also apply here. For
example, construction tasks, and specifically abrasive blasting, are
commonly performed outdoors. Exposure-generating tasks could be short
or long in duration and are typically performed at non-fixed
workstations or worksites. Moreover, construction tasks may move to
different locations during the workday. Such conditions could make it
difficult to establish and maintain regulated areas as required by the
general industry and shipyard standards.
At the same time, OSHA finds that construction workers, like their
counterparts in general industry and shipyards, need to be made aware
of those locations in their workplace where airborne exposures are, or
can reasonably be expected to be, above the TWA PEL or STEL. Therefore,
OSHA has decided to adopt the method that was recently included in the
recent respirable crystalline silica standard for construction, as well
as in some prior construction standards. There, in lieu of establishing
regulated areas, the Agency included a requirement for a designated
competent person to implement procedures in the written exposure
control plan to restrict access to work areas, where necessary, to
limit exposures to respirable crystalline silica to achieve the primary
objectives of a regulated area. OSHA has concluded that a similar
approach is appropriate in this rulemaking. The Agency finds that this
flexible approach balances the unique conditions of the construction
industry with the need to protect construction employees.
In summary, OSHA has decided to include regulated area requirements
in the final standards for general industry and shipyards. The
requirements to establish and maintain a regulated area wherever
employees are, or can reasonably be expected to be, exposed to airborne
beryllium at levels above the TWA PEL or STEL, can be found in
paragraph (e)(1)(ii) of the standard for general industry and (e)(1) of
the standard for shipyards. Other requirements related to regulated
areas, e.g., the requirements to identify and limit access to regulated
areas, are discussed in more detail below. In addition, OSHA has
decided not to include requirements for regulated areas in the final
construction standard, but has provided analogous protections for
construction employees through the competent person provisions in
paragraph (e) of the final construction standard. The competent person
requirements are also discussed in detail below.
In addition, NIOSH suggested that since demarcated areas may be
difficult to establish and maintain in some construction or maritime
settings, OSHA could consider alternative ways to provide the
protections associated with such areas to employees in these sectors.
For example, respiratory protection could be triggered by exposure to a
threshold airborne level, or dermal protections could be triggered
based on performance of tasks involving dermal contact with beryllium
(Document ID 1755, Tr. 21-22). OSHA has adopted NIOSH's suggestion to
tie certain protective measures to employee inhalation exposures or
dermal contact rather than using the intermediary step of establishing
demarcated areas where such areas are not required in the construction
or maritime sectors. For example, as explained below in the discussion
of competent person requirements, respiratory protection requirements
apply to employees in construction who have or may reasonably be
expected to have airborne exposure above the TWA PEL or STEL. In
addition, requirements for provision and use of PPE are triggered based
on the potential for dermal contact with beryllium in all three
standards (see the Summary and Explanation for paragraph (h), Personal
protective clothing and equipment). Thus, PPE is available to all
employees whose work may involve dermal contact with beryllium,
irrespective of whether they work in an industry where demarcated areas
are required.
Demarcation of regulated areas. Proposed paragraph (e)(2) included
the requirements for the demarcation of beryllium work areas and
regulated areas. Under proposed paragraph (e)(2)(i), employers were
required to identify each beryllium work area through signs or any
other methods that adequately establish and inform each employee of the
boundaries of each beryllium work area. OSHA explained that the
demarcation must effectively alert workers and other persons that
airborne beryllium may be present. Proposed paragraph (e)(2)(ii)
required employers to demarcate each regulated area in accordance with
the paragraph (m)(2) hazard communication provisions of this standard.
OSHA did not further specify requirements for demarcation, proposing
instead to offer employers flexibility in determining the best means to
demarcate beryllium work areas and regulated areas. The Agency
requested comment on each of these proposed provisions, including
whether the standard should specify what types of demarcation employers
must use or take a more performance-oriented approach. See 80 FR 47786.
OSHA received several comments on demarcation in general industry
and maritime settings. First, NIOSH advocated the need for more
specification on how to demarcate regulated areas (Document ID 1671,
Attachment 1, p. 6). OSHA believes, however, that allowing employers to
choose how to best demarcate regulated areas (as well as beryllium work
areas) is consistent with its preference for performance-based
approaches where, as here, the Agency has determined that employers,
based on their knowledge of the specific conditions of their workplace,
are in the best position to make such determinations. For example, if
an employer knows that exposures in a particular work area might exceed
the PEL on one particular day only, that employer might choose a
temporary method of demarcation. Conversely, an employer might choose
to use a more permanent method of demarcation for a beryllium work area
that contains a
potentially beryllium-releasing operation that occurs daily. In some
workplaces employers might choose to use barricades, in others textured
flooring, roped-off areas, "No entry"/"No access" signs, or painted
boundary lines. OSHA generally approves of each of these methods,
provided that the particular method or methods the employer selects are
clear and understandable enough to alert workers to the boundaries of
the beryllium work area or regulated area. This may mean, for example,
including more than one language on a sign, if the inclusion of a
second language would make the sign understandable to a particular
workforce with limited English reading skills.
OSHA has identified several factors that it considers to be
appropriate considerations for employers when they are determining how
to demarcate beryllium work areas and regulated areas. These factors
include the configuration of the beryllium work area or regulated area;
whether the beryllium work area or regulated area is permanent; the
airborne concentrations of beryllium in the beryllium work area or
regulated area; the number of employees working in areas adjacent to
any beryllium work area or regulated area; and the period of time the
beryllium work area or regulated area is expected to have hazardous
exposures. OSHA also notes that the use of a performance-oriented
approached to the demarcation of regulated areas is consistent with
previous health standards, such as respirable crystalline silica (29
CFR 1910.1053) and chromium (VI) (29 CFR 1910.1026).
Moreover, although proposed paragraph (e)(2)(ii) allowed employers
to demarcate regulated areas in a variety of ways, it also contained
specific requirements for the posting and wording of a warning sign in
accordance with proposed paragraph (m)(2). OSHA included this
requirement in the proposal because it preliminarily found that
employees must recognize when they are entering a regulated area, and
understand the hazards associated with the area, as well as the need
for respiratory protection. Signs are an effective means of
accomplishing these objectives. Therefore, OSHA included a proposed
requirement for employers to post all entrances to regulated areas with
signs that bear the following legend:
DANGER
BERYLLIUM
BERYLLIUM MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING AND EQUIPMENT IN
THIS AREA
Ameren, an electric power utility, objected to the proposal's
demarcation requirement. Specifically, Ameren stated that "[c]onfined
space areas such as a boiler penthouse during abrasive blasting
activities would be hard to demarcate since the entrance to the
regulated area is small and would block access to the area for
personnel and equipment. It would also be difficult to establish areas
for activities such as cleaning fly ash off of plant piping or
structural steel." Ameren suggested alternate, training-based means of
informing employees of beryllium exposures, such as job planning and
job safety briefings (Document ID 1675, p. 11). OSHA disagrees that its
performance-oriented approach does not accommodate these circumstances.
As discussed above, demarcation requirements for beryllium work areas
and regulated areas allow employers maximum flexibility in designing
forms of demarcation that best fit the nature of their facilities and
processes. Forms of demarcation, such as tape, that do not block access
to areas and can be applied in areas where fly ash is cleaned are not
difficult to design or implement. Furthermore, training to inform
employees of the location of beryllium exposures is a valuable
complement to, but should not replace, demarcation in the final
standards. The reinforcement of training with demarcation is an
important protection to ensure that employees, who may work frequently
in beryllium work areas and regulated areas, are continually aware of
the location of beryllium exposures in their workplace. See summary and
Explanation for paragraph (m), discussing employee training
requirements. Also, requirements for demarcation ensure that persons
other than employees, who may enter the worksite but may not receive
training, are adequately informed of the presence of beryllium.
Commenters also opined on the signage requirement in proposed
paragraph (e)(2)(ii). Specifically, the ABMA argued that the beryllium
specific signs required in the proposed standard for general industry
are not appropriate for use in shipyard abrasive blasting, since this
operation involves potential exposure to a number of hazardous
chemicals (Document ID 1673, p. 22). OSHA disagrees and is maintaining
the sign requirement in the final standards (with slightly altered
language, noted below). Beryllium specific signs are appropriate and
necessary to inform employees and others of the specific health hazards
associated with beryllium exposure. Although employees should also be
made aware of other hazardous chemicals they may be occupationally
exposed to, training and signage regarding these other chemicals must
necessarily be addressed elsewhere, and these concerns should not
preclude OSHA from requiring appropriate warning signs for beryllium
exposure. OSHA notes that in comments from the U.S. House of
Representatives Committee on Education and the Workforce, the committee
urged OSHA to implement "demarcation (through postings of warnings) if
there is abrasive blasting with beryllium containing materials" by
shipyard workers (Document ID 1672, p. 4).
After carefully reviewing the record, OSHA finds that the proposed
approach for the demarcation of beryllium work areas and regulated
areas strikes a reasonable balance between the difficulties of
establishing and maintaining these areas with the need to alert those
exposed of the risks involved, to reduce the number of employees
exposed to beryllium, and to protect those employees exposed to high
levels of airborne beryllium. In particular, OSHA finds that the
general performance-oriented approach in the proposed requirements,
when coupled with the specificity of the signage requirements for
regulated areas, provides employers with a good balance of direction
and flexibility. The final standards do not require employers to
establish and demarcate beryllium work areas or regulated areas by
permanently segregating and isolating processes generating airborne
beryllium. Instead, the standards allow employers to use temporary or
flexible methods to demarcate beryllium work areas and regulated areas.
In sum, OSHA finds that these flexible, performance-based requirements
will accommodate open work spaces, changeable plant layouts, and
sporadic or occasional beryllium use without imposing undue costs or
burdens. Therefore, OSHA has decided to include paragraphs (e)(2)(i)
and (e)(2)(ii), as proposed, in the final standard for general industry
and to include regulated areas demarcation requirements in paragraph
(e)(2) of the shipyard standard identical to those of paragraph
(e)(2)(ii) of the general industry standard. However, OSHA notes that
the required legend for the signage has been amended slightly to
include the words "REGULATED AREA," as discussed in the Summary and
Explanation for paragraph (m),
Communication of hazards, in this preamble. (OSHA is not including the
proposed demarcation provisions in the final standard for construction
because, as discussed above, the construction standard does not require
the establishment or maintenance of either beryllium work areas or
regulated areas.)
Paragraph (e)(3) of the proposed standard required employers to
limit access to regulated areas. Because of the serious health effects
of exposure to beryllium and the need for persons entering the
regulated area to be properly protected, OSHA proposed that the number
of persons allowed to access regulated areas should be limited to: (i)
Persons the employer authorizes or requires to be in a regulated area
to perform work duties; (ii) persons entering a regulated area as
designated representatives of employees for the purposes of exercising
the right to observe exposure monitoring procedures under paragraph
(d)(6) of this standard; and (iii) persons authorized by law to be in a
regulated area.
The first group, persons the employer authorizes or requires to be
in a regulated area to perform work duties, may include workers and
other persons whose jobs involve operating machinery, equipment, and
processes located in regulated areas; performing maintenance and repair
operations on machinery, equipment, and processes in those areas;
conducting inspections or quality control tasks; and supervising those
who work in regulated areas.
The second group encompasses persons entering a regulated area as
designated representatives of employees for the purpose of exercising
the right to observe exposure monitoring under paragraph (d)(7). As
explained in the summary and explanation section on paragraph (d) for
exposure assessment, providing employees and their representatives with
the opportunity to observe monitoring is consistent with the OSH Act
and OSHA's other substance-specific health standards, such as those for
respirable crystalline silica (29 CFR 1910.1053), cadmium (29 CFR
1910.1027), and methylene chloride (29 CFR 1910.1052).
The third group consists of persons authorized by law to be in a
regulated area. This category includes persons authorized to enter
regulated areas by the OSH Act, OSHA regulations, or any other
applicable law. OSHA compliance officers would fall into this group.
As discussed in the NPRM, limiting access to regulated areas
restricts the number of persons potentially exposed to beryllium at
levels above the TWA PEL or STEL, and thus reduces the risk of
beryllium-related health effects for employees and others who do not
need access to regulated areas. As explained previously in the Summary
and Explanation for paragraph (a), Scope and application, OSHA has
decided to extend all provisions of the general industry standard to
construction and shipyards except where the Agency finds that they are
not appropriate to construction and shipyard settings. OSHA did not
receive comments on this provision in the proposed standard, and did
not receive comments or evidence indicating that restricted access
areas are not appropriate in construction and shipyards. However, as
discussed previously, OSHA has determined that protections associated
with regulated areas in general industry will be more effectively
accomplished with a competent person provision in construction.
OSHA has therefore decided to retain paragraph (e)(3) as proposed
in the final standard for general industry, and to add an identical
provision to the shipyard standard and an analogous provision to the
construction standard. Thus, final paragraph (e)(3) requires employers
in general industry and shipyards to limit access to regulated areas
to: (i) Persons the employer authorizes or requires to be in a
regulated area to perform work duties; (ii) persons entering a
regulated area as designated representatives of employees for the
purposes of exercising the right to observe exposure monitoring
procedures under paragraph (d)(6) of this standard; and (iii) persons
authorized by law to be in a regulated area. And paragraph (e) of the
construction standard requires the designation of a competent person,
who, among other things, will implement the written exposure control
plan under paragraph (f) of this standard. As discussed in more detail
below, paragraph (f)(1)(i)(H) of the construction standard requires
employers to establish and implement procedures to restrict access to
work areas when airborne exposures are, or can reasonably be expected
to be, above the TWA PEL or STEL, to minimize the number of employees
exposed to airborne beryllium and their level of exposure, including
exposures generated by other employers or sole proprietors.
Proposed paragraph (e)(4) required employers to provide and ensure
that each employee entering a regulated area uses personal protective
clothing and equipment, including respirators, in accordance with
paragraphs (g) and (h) of the proposed standard. As discussed in the
NPRM, provisions for respiratory protection and PPE ensure that those
who must enter regulated areas are properly protected, thereby reducing
the risk of serious health effects associated with airborne beryllium
exposure and dermal contact with beryllium. As explained previously in
the Summary and Explanation for paragraph (a), Scope and application,
OSHA has decided to extend all provisions of the general industry
standard to construction and shipyards except where the Agency finds
that they are not appropriate to construction and shipyard settings.
OSHA did not receive comments on this provision in the proposed
standard for general industry, and did not receive comments or evidence
indicating that restricted access areas are not appropriate in
construction and shipyards. However, as discussed previously in this
section, OSHA has determined that protections associated with regulated
areas in general industry will be more effectively accomplished with a
competent person provision in construction.
OSHA has therefore decided to retain paragraph (e)(4) as proposed
in the final standard for general industry, and to add an identical
provision to the shipyard standard and an analogous provision to the
construction standard. Thus, final paragraph (e)(4) of the general
industry and shipyard standards requires employers to provide and
ensure that each employee entering a regulated area uses respiratory
protection in accordance with paragraph (g) and personal protective
clothing and equipment in accordance with paragraphs (h) of the final
standard for general industry. Wherever employees are, or can
reasonably be expected to be, exposed to airborne beryllium at levels
above the TWA PEL or STEL in construction settings, paragraph (e) of
the construction standard requires the employer to designate a
competent person to ensure that all employees use respiratory
protection and PPE in accordance with paragraphs (g) and (h) of the
standard.
Competent Person (Construction). To balance the unique conditions
present in the construction industry with the need to protect
construction industry employees from high airborne exposures, OSHA has
chosen to adopt an approach in the construction standard for
restricting access to high-exposure areas similar to that used in the
recent respirable crystalline silica standard for construction. This
approach requires the employer to designate a competent person or
persons, who will, among other things, implement the written exposure
control plan, including procedures used to
restrict access to work areas when airborne exposures are, or can
reasonably be expected to be, above the TWA PEL or STEL; ensure that
all employees use respiratory protection in accordance with paragraph
(g) of this standard; and ensure that all employees use personal
protective clothing and equipment in accordance with paragraph (h) of
this standard. OSHA finds this approach offers construction employers a
flexible means of providing protection to their employees.
The competent person requirement is a well-known and accepted
concept in OSHA standards; competent person provisions are included in
at least 20 of OSHA's construction standards, including OSHA substance-
specific standards for construction, such as lead (29 CFR 1926.62),
asbestos (29 CFR 1926.1101), cadmium (29 CFR 1926.1127), and respirable
crystalline silica (29 CFR 1926.1153). In addition, OSHA's general
safety and health provisions for construction require the employer to
initiate and maintain programs for accident prevention, as may be
necessary, and such programs require frequent and regular inspections
of job sites, materials, and equipment by a designated competent person
(29 CFR 1926.20(b)(1) and (2)).
Competent person provisions are also commonly included in American
National Standard Institute (ANSI) standards for construction. NIOSH
and its state partners also routinely recommend the need for, and role
of, designated competent persons in investigation reports conducted
under NIOSH's Fatality Assessment and Control Evaluation program. Thus,
OSHA finds that the use of a competent person is consistent with
current industry practices in that many construction employers are
already using a designated competent person.
Moreover, although OSHA did not include a competent person
requirement in the proposed rule, stakeholders indicated that such a
requirement would be appropriate if the Agency chose to include the
construction industry within the scope of this rulemaking. For example,
North America's Building Trades Unions (NABTU) testified that beryllium
construction work should be done under the supervision of a competent
person (Document ID 1756, Tr. 231-232). NABTU added that the most
important point of having a competent person designated in the standard
is to ensure there is an agent of the employer on site who has the
appropriate authority to correct hazards (Document ID 1805, Attachment
1, p. 4).
Based on these comments and the reasons described above, OSHA has
decided to include competent person requirements in the final rule for
construction, instead of requiring regulated areas. In paragraph (b) of
the construction standard, OSHA defines competent person as an
individual who is capable of identifying existing and foreseeable
beryllium hazards in the workplace and who has authorization to take
prompt corrective measures to eliminate or minimize them. The
definition also specifies that the competent person must have the
knowledge, ability, and authority necessary to fulfill the
responsibilities set forth in paragraph (e) of the construction
standard.
In order to craft an appropriate definition for this term, OSHA
considered stakeholder comments, including NABTU's above comments on
the need for a competent person in the construction standard, and the
definition of competent person in the safety and health regulations for
construction (29 CFR 1926.32(f)). Under 29 CFR 1926.32(f), competent
person is defined as a person capable of identifying existing and
predictable hazards in the surroundings or working conditions that are
unsanitary, hazardous, or dangerous to employees and who is authorized
to take prompt corrective measures to eliminate them. OSHA's definition
for competent person in the construction standard is consistent with
the 1926.32(f) definition with several minor changes. For example, the
Agency tailored this definition to beryllium by specifying "beryllium
hazards" instead of "unsanitary, hazardous, or dangerous"
conditions. In addition, OSHA replaced the word "one" with
"individual," which is merely an editorial change. The Agency also
removed the phrase "in the surroundings or working conditions" and
changed it to "in the workplace" to make it specific to the
workplace. And the Agency removed the phrase "to eliminate them" and
changed it to "to eliminate or minimize them" to denote there may be
cases where complete elimination would not be feasible. Finally, OSHA
changed "predictable" to "foreseeable" to make the wording
consistent with the scope of this construction standard (paragraph
(a)).
OSHA also decided that it was important to detail the necessary
characteristics and authority of a competent person in the standard to
ensure that he or she is truly competent to carry out the tasks
designated under paragraph (e). Thus, under paragraph (b) of the
construction standard, the competent person must have the knowledge,
ability, and authority necessary to fulfill the responsibilities set
forth in paragraph (e) of the construction standard. However, OSHA has
chosen not to specify particular training requirements for competent
persons. The Agency finds that it is not practical to specify in the
rule the elements and level of training required for a competent
person. And the Agency does not find it appropriate to mandate a "one
size fits all" set of training requirements to establish the
competency of competent persons in every conceivable construction
setting. Therefore, the training requirement for a competent person is
performance-oriented. This approach is consistent with most OSHA
construction standards, such as cadmium (29 CFR 1926.1127), lead (29
CFR 1926.62) and respirable crystalline silica (1926.1153), which
include a performance-based approach by not specifying training or
qualifications required for a competent person.
Like the regulated area provisions in general industry and
shipyards, paragraph (e)(1) of the construction standard applies
wherever employees are, or can reasonably be expected to be, exposed to
airborne beryllium at levels above the TWA PEL or STEL. As discussed in
more detail above with regard to the establishment and maintenance of
regulated areas in general industry and shipyards, OSHA finds that this
exposure level trigger is appropriate for provisions such as this one.
Paragraph (e) of the standard for construction further specifies
that wherever employees are, or can reasonably be expected to be,
exposed to airborne beryllium at levels above the TWA PEL or STEL, the
employer shall designate a competent person to: (1) Make frequent and
regular inspections of job sites, materials, and equipment; (2)
implement the written exposure control plan under paragraph (f) of this
standard; (3) ensure that all employees use respiratory protection in
accordance with paragraph (g) of this standard; and (4) ensure that all
employees use personal protective clothing and equipment in accordance
with paragraph (h) of this standard. OSHA finds that these
responsibilities, together, offer construction employees similar
protection to those afforded to general industry and shipyard employees
while offering construction employers more flexibility to suit their
workplaces.
Under paragraph (e)(1) of the construction standard, the competent
person must make frequent and regular
inspections of job sites, materials, and equipment. OSHA included this
requirement in order to ensure that the competent person has the
necessary information to carry out the rest of his or her duties. For
example, the competent person's second responsibility (as discussed
below) is to implement the written exposure control plan under
paragraph (f) of this standard. Among other things, the written
exposure control plan includes procedures for minimizing cross-
contamination (paragraph (f)(1)(i)(D)). In order to implement these
procedures on a construction worksite, the competent person may need to
know about the unique characteristics of the jobsite and the materials
and equipment used therein. Similarly, in order to carry out his or her
duty to implement the procedures used to restrict access to work areas
when airborne exposures are, or can reasonably be expected to be, above
the TWA PEL or STEL, and to minimize the number of employees exposed to
airborne beryllium and their level of exposure, including exposures
generated by other employers or sole proprietors, as required by
paragraph (f)(1)(i)(I), the competent person will equally need to be
familiar with the jobsite, materials, and equipment in order to know
where high exposures might occur.
Under paragraph (e)(2) of the construction standard, OSHA is
requiring that the competent person implement the written exposure
control plan because the plan specifies what must be done to
consistently identify and control beryllium hazards on a job site. See
Summary and Explanation for paragraph (f), Written exposure control
plan. In construction, a competent person is needed to ensure that the
requirements of the written exposure control plan are being met under
variable conditions. The subjects that must be included in the written
exposure control plan for construction are consistent with the duties
of a competent person in past OSHA standards. Therefore, this
requirement should be familiar to construction employers covered by
this standard.
In addition, under paragraph (f)(1)(i)(I) the written exposure
control plan must contain procedures used to restrict access to work
areas when airborne exposures are, or can reasonably be expected to be,
above the TWA PEL or STEL, to minimize the number of employees exposed
to airborne beryllium and their level of exposure, including exposures
generated by other employers or sole proprietors. By requiring the
competent person to implement these procedures, OSHA is offering
similar protection to construction employees as given to general
industry and shipyard employees through the regulated area provisions
in the general industry and shipyard standards.
OSHA is cognizant that the written exposure control plan
requirement regarding the exposures generated by other employers or
sole proprietors is important in construction because at multi-employer
worksites, the actions of one employer may expose employees of other
employers to hazards. A competent person can help communicate hazards
to other employers. OSHA expects that the employers or their competent
persons will work with general contractors at construction sites to
avoid high exposures of employees working alongside others by
implementing administrative procedures such as scheduling high-exposure
tasks when others will not be in the area. However, if this does not
occur, the competent person has authority to implement other
administrative procedures that would be effective for protecting
employees in situations where an employer was not made aware that
another employer or sole proprietor would be conducting abrasive
blasting operations on the worksite. Upon encountering such situations
on a worksite, the competent person is expected to remind employees to
stay away from the abrasive blasting site and make sure that employees
he or she oversees are positioned at a safe distance from the abrasive
blasting activity
In addition to limiting access to high exposure areas, the standard
for construction requires the competent person to ensure that employees
use respiratory protection and personal protective clothing and
equipment while in high exposure areas (paragraph (e)(3)-(4)). This is
an important requirement because without demarcated regulated areas,
employees would not have signs to remind them of the need to use such
protective equipment. It is therefore the competent person's
responsibility to provide the necessary warnings.
OSHA is not requiring a competent person for the general industry
and shipyard standards. OSHA has determined that in most cases, general
industry scenarios are not as variable as those in construction. For
example, most work is performed indoors and therefore, not subject to
variables such as wind shifts and moving exposure sources that could
significantly affect exposures or complicate establishment of regulated
areas. Employers covered under the general industry and shipyard
standards are more likely to have health and safety professionals on
staff who could assist with implementation of the standard. Finally,
competent persons have not been included in other OSHA substance-
specific standards for general industry. For example, a competent
person requirement was included in the construction standard for
cadmium because of environmental variability and the presence of
multiple employers on the job site, but a competent person requirement
was not included in the general industry standard for cadmium (29 CFR
1910.1027; 29 CFR 1926.1127; 57 FR 42101, 42382 (9/14/1992)). A
competent person requirement was included in the construction standard
for respirable crystalline silica for similar reasons (81 FR 16811).
These factors explain and support OSHA's conclusion that there is no
regulatory need for including a competent person requirement in the
beryllium standards for general industry and shipyards.
(f) Methods of Compliance
Paragraph (f) of the standards establishes methods for reducing
employee exposure to beryllium through the use of a written exposure
control plan and engineering and work practice controls. Paragraph
(f)(1)(i) of each of the standards requires employers to establish,
implement, and maintain a written exposure control plan and specifies
the information that must be included in the plan. Paragraph (f)(1)(ii)
establishes requirements for employers to review their plan(s) at least
annually and update it under specified circumstances. Finally,
paragraph (f)(1)(iii) requires employers to make a copy of the written
exposure control plan accessible to each employee who is, or can
reasonably be expected to be, exposed to airborne beryllium.
Paragraph (f)(2) of the final standards requires employers to
implement engineering and work practice controls to reduce beryllium
exposures to employees. Where airborne exposure exceeds the TWA PEL or
STEL, the employer must implement engineering and work practice
controls to reduce airborne exposure to or below the exceeded exposure
limit(s). Wherever the employer demonstrates that it is not feasible to
reduce airborne exposure to or below the PELs by engineering and work
practice controls, the employer must implement and maintain engineering
and work practice controls to reduce airborne exposure to the lowest
levels feasible and supplement these controls by using respiratory
protection in accordance with paragraph (g) of this standard. In
addition,
paragraph (f)(2) includes limited requirements for implementation of
exposure controls where operations release airborne beryllium exceeding
the action level. Finally, paragraph (f)(3) prohibits the employer from
rotating employees to different jobs to achieve compliance with the TWA
PEL and STEL.
Paragraph (f)(1)(i) of the proposed rule would have required
employers to establish, implement, and maintain a written exposure
control plan for beryllium work areas, containing an inventory of
operations and job titles reasonably expected to have exposure at or
above the action level; an inventory of operations and job titles
reasonably expected to have exposure above the TWA PEL or STEL;
procedures for minimizing cross-contamination, keeping surfaces in the
beryllium work area as free as practicable of beryllium; minimizing the
migration of beryllium from beryllium work areas to other locations
within or outside the workplace, and removal, laundering, storage,
cleaning, repairing, and disposal of beryllium-contaminated personal
protective clothing and equipment, including respirators; and an
inventory of engineering and work practice controls required by
paragraph (f)(2) of the proposed standard.
Several commenters offered broad support for the inclusion of
paragraph (f)(1)'s provisions in the final rule (e.g., Document ID
1681, Attachment 1, p. 9; 1689, p. 11; 1690, p. 1). For example, United
Steelworkers (USW) stated: "[a] written plan will help to ensure that
exposure controls and safety practices are continually followed. This
will also provide workers and other stakeholders with information
necessary in evaluating the health and safety protections and
provisions provided by the employer" (Document ID 1681, p. 9). The
American Federation of Labor and Congress of Industrial Organizations
(AFL-CIO) also supported the inclusion of written exposure control plan
requirements (Document ID 1689, p. 11). It argued that "[r]equiring
employers to properly make use of a written plan is an essential tool
for continuously controlling exposures and using proper safety
practices" (Document ID 1689, p. 11). The National Council for
Occupational Safety and Health (National COSH) agreed, stating that
"[a] comprehensive program to protect workers from these exposures,
that includes a requirement for a written beryllium control plan,
regular exposure monitoring, medical surveillance, medical removal
protection benefits, and training would provide much needed protection
for beryllium exposed workers" (Document ID 1690, p. 1). Written
exposure control plan requirements were also included in the draft
proposed rule submitted to the Agency by Materion Corporation
(Materion) and United Steelworkers (USW) (Document ID 0754, p. 6).
OSHA agrees with the opinions expressed by these commenters.
Requiring employers to articulate where exposures occur and how those
exposures will be controlled will help to ensure that they have a
complete understanding of the controls needed to comply with the rule.
Thus, OSHA expects a written exposure control plan will be instrumental
in ensuring that employers comprehensively and consistently protect
their employees. Consequently, the Agency has decided to include
written exposure control plan requirements in paragraph (f)(1) of the
final standards.
In the preamble to the proposal, OSHA explained that adherence to
the written exposure control plan will help reduce skin contact with
beryllium, which can lead to beryllium sensitization, and airborne
exposure, which can lead to beryllium sensitization, CBD, and lung
cancer (80 FR 47787). Because skin contact and airborne exposure can
occur in any workplace within the scope of the standard, OSHA
preliminarily decided to require a written exposure control plan for
all employers within the scope of the standard.
OSHA received comments regarding the proposed trigger for written
exposure control plan requirements. For example, NGK Metals Corporation
(NGK) argued that requiring employers to develop and maintain a written
exposure control plan for facilities where exposures are below the
action level is burdensome, and recommended that the written plan be
required only where exposures exceed the action level (Document ID
1663, p. 2). EEI asserted that a requirement for a written exposure
control plan should apply to areas where exposures meet or exceed the
action level or PEL, so as to be consistent with other health standards
(Document ID 1674, p. 13).
OSHA has re-examined the provisions of (f)(1) in light of these
comments and reaffirms its preliminary decision to require all
employers within the scope of the standard to establish, implement, and
maintain a written exposure control plan. The Agency finds that the
requirements that apply where exposures are below the action level
(e.g., a list of operations and job titles reasonably expected to
involve airborne exposure or dermal contact with beryllium;
descriptions of procedures for handling beryllium-contaminated PPE and
respirators; and descriptions of procedures for minimizing cross-
contamination and migration of beryllium) are important to preventing
beryllium sensitization and CBD, and are not overly burdensome.
Moreover, many of the requirements in the plan are intended to
complement the housekeeping and hygiene requirements that all
facilities in the scope of the standard must already meet, and do not
create significant burdens for employers beyond documentation of their
procedures for meeting the requirements of other paragraphs in the
standards, such as (h) Personal protective clothing and equipment, (i)
Hygiene areas and practices, and (j) Housekeeping.
Proposed paragraph (f)(1)(i)(A)-(H) set forth the required contents
of the written exposure control plan. Under the proposal, the
employer's written exposure control plan was required to include: (1)
An inventory of operations and job titles reasonably expected to have
exposure; (2) an inventory of operations and job titles reasonably
expected to have exposure at or above the action level; (3) an
inventory of operations and job titles reasonably expected to have
exposure above the TWA PEL or STEL; (4) procedures for limiting
beryllium contamination, including but not limited to preventing the
transfer of beryllium between surfaces, equipment, clothing, materials,
and articles within the beryllium work area; (5) procedures for keeping
surfaces in the beryllium work area as free as practicable of
beryllium; (6) procedures for minimizing the migration of beryllium
from beryllium work areas to other locations within or outside the
workplace; (7) an inventory of engineering and work practice controls
used by the employer to comply with paragraph (f)(2) of this standard;
and (8) procedures for removal, laundering, storage, cleaning,
repairing, and disposal of beryllium-contaminated personal protective
clothing and equipment, including respirators.
Stakeholders offered comments on the proposed written control plan
contents. For example, the Boeing Company suggested that OSHA should
revise the proposed provision requiring "procedures for keeping
surfaces in the beryllium work area as free as practicable of
beryllium" to define specific surface contaminant levels (Document ID
1667, p. 4). The apparent advantage of providing a target surface
contaminant level is that employers could use surface sampling to
determine whether they are in compliance with the standard's
requirements for surface cleaning. However, as OSHA explained
in the Summary and Explanation for paragraph (j), Housekeeping, the
relationship between a precise amount of surface contamination and
health risk is unknown. Therefore, OSHA cannot find that a particular
level of contamination is safe. Rather, OSHA has determined that
keeping surfaces as clean as practicable is appropriate because
promptly removing beryllium deposits prevents them from becoming
airborne, thus reducing employees' inhalation exposure, and helps to
minimize the likelihood of skin contact with beryllium. Moreover, the
term "free as practicable" is accepted language and has been used in
previous standards, such as standards addressing exposure to lead and
chromium (VI). Consequently, OSHA has decided to retain the "free as
practicable" language in the final rule for general industry. (As
discussed in more detail below, the final standards for construction
and shipyards do not include this requirement.)
After careful consideration of the record, OSHA reaffirms the need
for the written exposure control plan to contain each of the provisions
included in the proposal. This written record of which operations and
job titles are likely to have exposures at certain levels and which
housekeeping provisions and engineering and work practice controls the
company has selected to control exposures required in paragraph (f)
will make it easier for employers to implement monitoring, hygiene
practices, housekeeping, engineering and work practice controls, and
other measures. The provisions contained in (f)(1)(i)(D), (E), (F), and
(H) of the proposed rule will work to minimize the spread of beryllium
throughout and outside the workplace and to reduce the likelihood of
skin contact and re-entrainment of beryllium particulate.
Therefore, OSHA has decided to retain the proposed contents of the
written exposure control plan in the standard for general industry,
with the following revisions. First, OSHA has modified the proposed
requirement to include an inventory of operations and job titles
reasonably expected to have exposure, including by dermal contact. As
discussed in detail in the Summary and Explanation for paragraph (h),
Personal protective clothing and equipment (PPE), OSHA finds that it is
important to protect employees from dermal contact with beryllium. OSHA
therefore finds that the written exposure control plan should inform
employees and others of jobs and operations where dermal contact with
beryllium is reasonably expected, and has added dermal contact with
beryllium to paragraph (f)(1)(i)(A) of the final standards. Thus, the
final standard for general industry requires the employer to include a
list of operations and job titles reasonably expected to involve
airborne exposure to beryllium or dermal contact with beryllium in
their written exposure control plan(s).
Second, OSHA modified the language of proposed paragraphs
(f)(1)(i)(A), (B), (C), and (G) by replacing the term "inventory"
with the term "list". This change in wording does not imply a change
in the intent of the provision. Rather, OSHA made this change to
clarify the Agency's intent to require employers to simply identify
jobs, operations and controls that match the criteria of these
provisions, and that employers are not required to provide more
extensive description of such jobs and operations. Third, OSHA modified
(f)(1)(i)(D) by deleting "but not limited to" from the phrase
"including but not limited to preventing the transfer of beryllium",
because the term "including" implies that the examples to follow are
not intended to be exhaustive. This change in wording does not imply a
change in the intent of the provision.
Fourth, OSHA has edited the proposed text, which required an
"inventory" of operations and job titles reasonably expected to
"have" exposure; exposure at or above the action level; and exposure
above the TWA PEL or STEL. The final text requires a "list" of
operations and job titles reasonably expected to "involve" airborne
exposure to or dermal contact with beryllium; airborne exposure at or
above the action level; and airborne exposure above the TWA PEL or
STEL. This is an editorial change to provide greater clarity to better
describe the actual requirement, and does not change the intent of the
provision. Fifth, OSHA modified the proposed requirement to inventory
engineering and work practice controls required by paragraph (f)(2) of
this standard to include respiratory protection. This change ensures
that the respiratory protection requirement, which is included in
(f)(2)(iv) of the final standards, is treated in the same manner as the
engineering and work practices control requirements in (f)(2)(i) and
(f)(2)(iii).
Finally, OSHA has included one additional provision in the final
rule for general industry that was not contained in the proposal.
Specifically, paragraph (f)(1)(i)(H) of the final rule requires
employers to include within their written exposure control plan a list
of personal protective clothing and equipment required by paragraph (h)
of this standard. This provision is added in recognition of the
importance of personal protective clothing and equipment in protecting
exposed employees, particularly those employees who may have dermal
contact with beryllium. With the addition of this new provision,
proposed paragraph (f)(1)(i)(H) (regarding procedures for removal,
laundering, storage, cleaning, repairing, and disposal of beryllium-
contaminated personal protective clothing and equipment, including
respirators) has been redesignated as paragraph (f)(1)(i)(I) of the
final rule for general industry.
OSHA has incorporated most provisions of the proposed paragraph
(f)(1)(i) into the final standards for construction and shipyards, with
certain modifications due to the work processes and worksites
particular to these sectors. As explained in the Summary and
Explanation for paragraph (j), Housekeeping, OSHA has determined that
abrasive blasting operations are the primary source of beryllium
exposure in the construction and shipyard sectors and has chosen not to
include provisions related to surface cleaning in the final standards
for these sectors due to the extreme difficulty of maintaining clean
surfaces during blasting operations. OSHA has therefore decided to
exclude the provision regarding procedures for keeping surfaces as free
as practicable of beryllium (proposed paragraph (f)(1)(i)(E)) from the
construction and shipyard standards. And due to the difficulty of
controlling contamination during blasting operations, OSHA has decided
to include a more performance-oriented provision on cross-contamination
in the standards for construction and shipyards than in paragraph
(f)(1)(i)(D) of the general industry standard. Employers are still
required to establish and implement procedures for minimizing cross-
contamination of beryllium in construction and shipyard industries.
However, the written exposure control plan provision on cross-
contamination simply requires "procedures for minimizing cross-
contamination"; it does not specify "procedures for minimizing cross-
contamination, including preventing the transfer of beryllium between
surfaces, equipment, clothing, materials, and articles within beryllium
work areas" as in general industry. OSHA has included the proposed
provision for minimizing the migration of beryllium in the standards
for construction and shipyards, but has removed the reference to
beryllium work areas since these are not established in construction
and shipyards. The written exposure control plan provision on migration
in these sectors requires the plan to include "procedures for
minimizing the migration of beryllium within or to locations outside
the workplace."
Because the requirements pertaining to surfaces contained in final
paragraph (f)(1)(i)(E) of the general industry standard do not appear
in the construction and shipyard standards, the numbering of the
provisions differs from that of the general industry standard. For the
construction and shipyard standards, requirements pertaining to the
migration of beryllium appear in paragraphs (f)(1)(i)(E); requirements
for a list of engineering controls, work practices, and respiratory
protection are in paragraphs (f)(1)(i)(F); requirements for a list of
personal protective clothing and equipment are in paragraphs
(f)(1)(i)(G); and requirements pertaining to removal, laundering,
storage, cleaning, repairing, and disposal of beryllium-contaminated
personal protective clothing and equipment, including respirators,
appear in paragraph (f)(1)(i)(H). Additional discussion of some of
these requirements may be found in this section of the preamble,
Summary and Explanation, at paragraph (h), Personal Protective Clothing
and Equipment; paragraph (i), Hygiene Areas and Practices; and
paragraph (j), Housekeeping.
OSHA has also included paragraph (f)(1)(i)(I) in the construction
standard only, requiring employers in the construction sector to
establish, implement and maintain procedures to restrict access where
airborne exposures are, or can reasonably be expected to be, above the
TWA PEL or STEL. This addition is related to OSHA's decision, explained
in the Summary and Explanation of paragraph (e), not to include a
requirement to establish regulated areas in the construction standard,
and to achieve the protective benefits associated with regulated areas
by other means. In the general industry and shipyard standards, the
employer must limit access to regulated areas to persons who are
authorized or required to be in a regulated area to perform work
duties, observation, or other limited circumstances. OSHA has
determined that restricting access to areas where airborne exposures
exceed or may reasonably be expected to exceed the TWA PEL or STEL is
appropriate to reduce employees' and others' risk of adverse health
effects associated with airborne beryllium exposure. OSHA has therefore
established alternative methods to ensure that construction employees
do not enter such areas unnecessarily. To this end, the final standard
for construction includes paragraph (f)(1)(i)(I), which requires
employers to establish, implement and maintain procedures used to
restrict access to work areas when airborne exposures are, or can
reasonably be expected to be, above the TWA PEL or STEL, in order to
minimize the number of employees exposed to airborne beryllium and
their level of exposure, including exposures generated by other
employers or sole proprietors. Significantly, the construction standard
additionally includes paragraph (e), Competent Person, which requires
employers to designate a competent person to implement the written
exposure control plan. The competent person is therefore responsible
for ensuring that the procedures to restrict access are followed in the
workplace.
National Jewish Health (NJH) submitted a comment to OSHA regarding
the importance of training, labeling, housekeeping measures, restricted
entry to beryllium-contaminated areas, and technologies such as sticky
mats and boot scrubbers in controlling employees' exposure to
beryllium. NJH requested that OSHA emphasize the importance of such
measures in paragraph (f) of these standards (Document ID 1664, p. 6).
OSHA agrees with NJH that all of these approaches are helpful, and in
some cases essential, to reducing employees' exposure. Training and
some forms of labeling and access restriction are specifically required
in other paragraphs of the standards. Specific tools such as sticky
mats and boot scrubbers are not required in the standards, but are
approaches employers should consider as part of their control
procedures. All of the methods mentioned by NJH are ways to limit
migration of beryllium and cross-contamination, and are therefore
appropriate for inclusion in an employer's written exposure control
plan(s).
The final standards' paragraph (f)(1)(i) differs from the proposal
in that it requires a written exposure control plan for each facility,
whereas the proposal would have required a written exposure control
plan for beryllium work areas within each facility. In addition, OSHA
has removed the phrase "in the beryllium work area" from provision
(f)(1)(i)(E) of the final standard for general industry, so that it now
reads: "Procedures for keeping surfaces as free as practicable of
beryllium". OSHA made these changes because it changed the definition
of a "beryllium work area" in the proposed standard for general
industry. The proposed standard defined a beryllium work area to
include any area where employees are, or can reasonably be expected to
be, exposed to airborne beryllium, regardless of the level of exposure.
As discussed previously in the Summary and Explanation for paragraph
(e), the final standard for general industry defines a beryllium work
area to include only those areas containing a process or operation that
releases beryllium where employees are, or can reasonably be expected
to be, exposed to airborne beryllium at any level or where there is the
potential for dermal contact with beryllium. Accordingly, OSHA made
these changes to the wording of (f)(1)(i) and (f)(1)(i)(E) to maintain
the intent of proposed paragraph (f)(1)(i)(A), to require employers to
list all jobs and operations throughout their facilities involving
beryllium exposure, and paragraph (f)(1)(i)(E) to control dermal
contact with beryllium wherever airborne beryllium may settle on
surfaces in their facilities. If employers' procedures to prevent
migration of beryllium from work areas to other areas of the facility
are fully effective (paragraph (f)(1)(i)(F)), further steps to keep
surfaces as free as practicable of beryllium will not be necessary.
However, if the employer is unable to consistently prevent transfer of
beryllium from work areas to other areas of the facility, the employer
must develop and implement additional procedures to keep surfaces
outside of the beryllium work areas as free as practicable of
beryllium.
Paragraph (f)(1)(ii) of the proposed rule would have required the
employer to update the exposure control plan when: (A) Any change in
production processes, materials, equipment, personnel, work practices,
or control methods results or can reasonably be expected to result in
new or additional exposures to beryllium; (B) an employee is confirmed
positive, is diagnosed with CBD, or shows signs or symptoms associated
with exposure; or (C) the employer has any reason to believe that new
or additional exposures are occurring or will occur. OSHA did not
receive any comments on this provision. However, as noted in the
proposal, employers such as Materion and Axsys Technologies, who have
worked to identify and document the exposure sources associated with
cases of sensitization and CBD in their facilities, have used this
information to develop and update beryllium exposure control plans
(Document ID 0634; 0473; 0599). OSHA found that this process, whereby
an employer uses employee health outcome data to check and improve the
effectiveness of the employer's exposure
control plan, is consistent with other performance-oriented aspects of
these standards. Thus, after considering the record on this issue, OSHA
has decided to retain proposed paragraph (f)(1)(ii) in the final rule,
with the modifications discussed below, to ensure that the employer's
plan reflects the current conditions in the workplace.
The first modification is that OSHA added a requirement to review
and evaluate the effectiveness of each written exposure control plan at
least annually. OSHA finds that an annual review is appropriate because
workplace conditions can change. In addition, by requiring employers to
check the effectiveness of their plans annually, the standards offer
employers the opportunity to better protect their employees by
reflecting on any lessons learned throughout the previous year. The
final annual review requirement is consistent with previous OSHA
standards, such as the standards addressing bloodborne pathogens (29
CFR 1910.1030) and respirable crystalline silica (29 CFR 1910.1053).
Second, OSHA changed the proposed language of (f)(1)(ii)(B), which
would have required employers to update their written exposure control
plans when an employee is confirmed positive for beryllium
sensitization, is diagnosed with CBD, or shows signs or symptoms
associated with exposure. This change is related to another change from
the proposed standard, which would have required notification of
employers whenever an employee is confirmed positive for beryllium
sensitization. As explained in the Summary and Explanation for
paragraph (k), Medical Surveillance, OSHA has modified this provision
so that employers are not automatically notified of cases of
sensitization or CBD among their employees. However, employers will
receive a written medical opinion from the licensed physician that may
include a referral for an evaluation at a CBD Diagnostic Center (see
(k)(6)(iii)) or a recommendation for medical removal from exposure to
beryllium (see (k)(6)(v)). An employee may also provide the employer
with a written medical report indicating a confirmed positive finding
or CBD diagnosis. Final paragraph (f)(1)(ii)(B) has been revised from
the proposal to reflect the circumstances under the final standards
where an employer will be notified that an employee has, or may have, a
beryllium-related health effect. This includes when the employer is
notified that an employee is eligible for medical removal in accordance
with paragraph (l)(1) of the standard (i.e., when the employee provides
the employer with a written medical report indicating a confirmed
positive finding or CBD diagnosis, or the employer receives a written
medical opinion recommending removal from exposure to beryllium); when
the employer is notified that an employee is referred for evaluation at
a CBD Diagnostic Center, or when an employee shows signs and symptoms
associated with exposure. Third, OSHA further modified (f)(1)(ii)(B) to
clarify the Agency's understanding that signs and symptoms may be
related to inhalation or dermal exposure, as discussed in Section V,
Health Effects. Final paragraph (f)(1)(ii)(B) therefore refers to signs
and symptoms of "airborne exposure to or dermal contact with
beryllium". Fourth, OSHA modified the wording of (f)(1)(ii) to require
the employer to update "each" written exposure control plan rather
than "the" written exposure control plan, since an employer who
operates multiple facilities is required to establish, implement and
maintain a written exposure control plan for each facility.
Paragraph (f)(1)(ii) of the final standards thus requires the
employer to review and evaluate the effectiveness of each written
exposure control plan at least annually and update it when: (A) Any
change in production processes, materials, equipment, personnel, work
practices, or control methods results or can reasonably be expected to
result in new or additional airborne exposure to beryllium; (B) the
employer is notified that an employee is eligible for medical removal
in accordance with paragraph (l)(1) of this standard, referred for
evaluation at a CBD Diagnostic Center, or shows signs or symptoms
associated with airborne exposure to or dermal contact with beryllium;
or (C) the employer has any reason to believe that new or additional
airborne exposure is occurring or will occur.
Paragraph (f)(1)(iii) of the proposed rule would have required the
employer to make a copy of the exposure control plan accessible to each
employee who is or can reasonably be expected to be exposed to airborne
beryllium in accordance with OSHA's Access to Employee Exposure and
Medical Records (Records Access) standard (29 CFR 1910.1020(e)). As
discussed above and in the NPRM, access to the exposure control plan
will enable employees to partner with their employers in keeping the
workplace safe. OSHA did not receive comments specific to this
provision, and has decided to retain it in the final standard for
general industry and include it in the final standards for construction
and shipyards.
Proposed paragraph (f)(2) established a hierarchy of controls that
employers must use to reduce beryllium exposures. This paragraph
required employers to rely on engineering and work practice controls as
the primary means to reduce exposures. As a general matter, where
airborne exposure exceeded the TWA PEL or STEL, proposed paragraph
(f)(2) required employers to implement engineering and work practice
controls to reduce airborne exposure to or below the PELs. Wherever the
employer demonstrated that it is not feasible to reduce airborne
exposure to or below the PELs through the use of engineering and work
practice controls, the employer would have been required to implement
and maintain engineering and work practice controls to reduce airborne
exposure to the lowest levels feasible and supplement these controls by
using respiratory protection in accordance with paragraph (g) of this
standard. In addition, proposed paragraph (f)(2) included limited
requirements for implementation of exposure controls for each operation
in a beryllium work area.
OSHA's long-standing hierarchy of controls policy was supported by
a number of commenters, including USW; the Sampling and Analysis
Subcommittee Task Group of the Beryllium Health and Safety Committee
(BHSC Task Group); AWE; AFL-CIO; 3M; and National Jewish Health (e.g.,
Document ID 1963, p. 12; 1655, pp. 8, 16; 1618, p. 8 (pdf); 1689, p.
11; 1625, p. 6 (pdf); 1664, p. 6). For example, the BHSC Task Group
stated that OSHA's mandate "to assure safe and healthy workplaces
requires it to reinforce fundamental industrial hygiene tenets. Prime
among these is application of a hierarchy of controls" (Document ID
1655, p. 16). Similarly, 3M indicated that it "agree[d] with OSHA that
the hierarchy of controls--effective engineering and work practice
controls--should be the primary means to help reduce employee exposures
to beryllium and its compounds" (Document ID 1625, p. 6 (pdf)). 3M
added that "when engineering controls and work practices cannot reduce
employee exposure to beryllium to below the PEL, then the employer must
protect employees' respiratory health through the use of respirators"
(Document ID 1625, p. 6 (pdf)). NJH added that
. . . engineering and/or work practice controls are critical in
reducing beryllium exposure and we have consulted with clients on
this issue. In identifying controls, using the hierarchy of
industrial controls to start with elimination or substitution . . .
followed by engineering controls and process
controls such as enclosures, local exhaust ventilation, and wet
methods . . . is crucial (Document ID 1664, p. 6).
After a careful review of the record, OSHA concludes that requiring
primary reliance on engineering and work practice controls is necessary
and appropriate because reliance on these methods is consistent with
good industrial hygiene practice, with the Agency's experience in
ensuring that workers have a healthy workplace, and with OSHA's
traditional adherence to a hierarchy of controls. The Agency finds that
engineering controls are reliable, provide consistent levels of
protection to a large number of workers, can be monitored continually
and inexpensively, allow for predictable performance levels, and can
efficiently remove toxic substances from the workplace. Once removed,
the toxic substances no longer pose a threat to employees. The
effectiveness of engineering controls does not generally depend to any
substantial degree on human behavior, and the operation of control
equipment is not as vulnerable to human error as is personal protective
equipment.
OSHA has identified several key methods of reducing exposures: (1)
Substitution; (2) isolation (e.g., enclosures); (3) ventilation; and
(4) process controls (e.g. wet methods, automation). Substitution
refers to the replacement of a toxic material with another material
that reduces or eliminates the harmful exposure. When available,
substitution can replace a toxic material in the work environment with
a non-toxic material, thus eliminating the risk of adverse health
effects.
Isolation, i.e., separating workers from the source of the hazard,
is another effective engineering control employed to reduce exposures
to beryllium. Isolation can be accomplished by either containing the
hazard or isolating workers from the source of the hazard. For example,
to contain the hazard, an employer might install a physical barrier
around the source of exposure to contain a toxic substance within the
barrier. Isolating the source of a hazard within an enclosure restricts
respirable dust from spreading throughout a workplace and exposing
employees who are not directly involved in exposure-generating
operations. Or, alternatively, an employer might isolate employees from
the hazard source by placing them in a properly ventilated space or at
some distance from the source of the beryllium exposure.
Ventilation is another engineering control method used to minimize
airborne concentrations of a contaminant by supplying or exhausting
air. The primary type of ventilation system used to control beryllium
exposure is local exhaust ventilation (LEV). LEV is used to remove an
air contaminant by capturing it at or near the source of emission,
before the contaminant spreads throughout the workplace. If designed
properly, LEV systems efficiently remove contaminants and provide for
cleaner and safer work environments.
Work practice controls involve adjustments in the way a task is
performed. In many cases, work practice controls complement engineering
controls in providing worker protection. For example, periodic
inspection and maintenance of process equipment and control equipment
such as ventilation systems is an important work practice control.
Frequently, equipment which is in disrepair or near failure will not
perform normally. Regular inspections can detect abnormal conditions so
that timely maintenance can then be performed. If equipment is
routinely inspected, maintained, and repaired or replaced before
failure is likely, there is less chance that hazardous exposures will
occur.
Workers must know the proper way to perform their job tasks in
order to minimize their exposure to beryllium and to maximize the
effectiveness of control measures. For example, if an exhaust hood is
designed to provide local ventilation and a worker performs a task that
generates a contaminant away from the exhaust hood, the control measure
will be of no use. Workers can be informed of proper operating
procedures through information and training. Good supervision further
ensures that proper work practices are carried out by workers. By
persuading a worker to follow proper procedures, such as positioning
the exhaust hood in the correct location to capture the contaminant, a
supervisor can do much to minimize unnecessary exposure. Employees'
exposures can also be controlled by scheduling operations with the
highest exposures at a time when the fewest employees are present.
Under the hierarchy of controls, respirators can be another means
of providing employees effective protection from exposure to air
contaminants. However, to be effective, respirators must be
individually selected, fitted and periodically refitted,
conscientiously and properly worn, regularly maintained, and replaced
as necessary. In many workplaces, these conditions for effective
respirator use are difficult to achieve. The absence of any one of
these conditions can reduce or eliminate the protection the respirator
provides to some or all of the employees. For example, certain types of
respirators require the user to be clean shaven to achieve an effective
seal where the respirator contacts the employee's skin. Failure to
ensure a tight seal due to the presence of facial hair compromises the
effectiveness of the respirator.
Respirator effectiveness ultimately relies on employers educating
employees on the necessary good work practices and ensuring that
employees adopt those practices. In contrast, the effectiveness of
engineering controls does not rely so heavily on actions of individual
employees. Engineering and work practice controls are capable of
reducing or eliminating a hazard from a worksite, while respirators
protect only the employees who are wearing them correctly. Furthermore,
engineering and work practice controls permit the employer to evaluate
their effectiveness directly through air monitoring and other means. It
is considerably more difficult to directly measure the effectiveness of
respirators on a regular basis to ensure that employees are not
unknowingly being overexposed. OSHA therefore continues to consider the
use of respirators to be the least satisfactory approach to exposure
control.
In addition, use of respirators in the workplace presents other
safety and health concerns. Respirators can impose substantial
physiological burdens on employees, including the burden imposed by the
weight of the respirator; increased breathing resistance during
operation; limitations on auditory, visual, and olfactory sensations;
and isolation from the workplace environment. Job and workplace factors
such as the level of physical work effort, the use of protective
clothing, and temperature extremes or high humidity can also impose
physiological burdens on employees wearing respirators. These stressors
may interact with respirator use to increase the physiological strain
experienced by employees.
Certain medical conditions can compromise an employee's ability to
tolerate the physiological burdens imposed by respirator use, thereby
placing the employee wearing the respirator at an increased risk of
illness, injury, and even death. These medical conditions include
cardiovascular and respiratory diseases (e.g., a history of high blood
pressure, angina, heart attack, cardiac arrhythmias, stroke, asthma,
chronic bronchitis, emphysema), and reduced pulmonary function caused
by other factors (e.g., smoking or prior exposure to respiratory
hazards), neurological or
musculoskeletal disorders (e.g., epilepsy, lower back pain), and
impaired sensory function (e.g., a perforated ear drum, reduced
olfactory function). Psychological conditions, such as claustrophobia,
can also impair the effective use of respirators by employees and may
also cause, independent of physiological burdens, significant
elevations in heart rate, blood pressure, and respiratory rate that can
jeopardize the health of employees who are at high risk for
cardiopulmonary disease (see 63 FR 1152, 1208-1209 (1/8/98)).
In addition, safety problems created by respirators that limit
vision and communication must always be considered. In some difficult
or dangerous jobs, effective vision or communication is vital. Voice
transmission through a respirator can be difficult, annoying, and
fatiguing. In addition, movement of the jaw in speaking can cause
leakage, thereby reducing the efficiency of the respirator and
decreasing the protection afforded the employee. Skin irritation can
result from wearing a respirator in hot, humid conditions. Such
irritation can cause considerable distress to employees and can cause
employees to refrain from wearing the respirator, thereby rendering it
ineffective.
These potential burdens placed on employees by the use of
respirators were acknowledged in OSHA's revision of its respiratory
protection standard, and are the basis for the requirement (29 CFR
1910.134(e)) that employers provide a medical evaluation to determine
the employee's ability to wear a respirator before the employee is fit
tested or required to use a respirator in the workplace (see 63 FR at
1152). Although experience in industry shows that most healthy
employees do not have physiological problems wearing properly chosen
and fitted respirators, nonetheless common health problems can cause
difficulty in breathing while an employee is wearing a respirator.
For these reasons, all OSHA substance-specific health standards
have recognized and required employers to observe the hierarchy of
controls, favoring engineering and work practice controls over
respirators. And the Agency's adherence to the hierarchy of controls
has been successfully upheld by the courts (see Section II, Pertinent
Legal Authority for further discussion of these cases).
Therefore, OSHA has decided to require the use of the long-
established hierarchy of controls in this standard. Because engineering
and work practice controls are capable of reducing or eliminating a
hazard from the workplace, while respirators protect only the employees
who are wearing them and depend on the selection and maintenance of the
respirator and the actions of employees, OSHA holds to the view that
engineering and work practice controls offer more reliable and
consistent protection to a greater number of employees, and are
therefore preferable to respiratory protection. Thus, the Agency
continues to conclude that engineering and work practice controls
provide a more protective first line of defense than respirators and
must be used first when feasible.
The provisions related to engineering and work practice controls
begin in paragraph (f)(2)(i). Paragraph (f)(2)(i)(A) of the proposed
rule stated that, for each operation in a beryllium work area (i.e.,
any work area involving airborne beryllium exposure), the employer
shall ensure that at least one of the following engineering and work
practice controls is in place to minimize employee exposure: (1)
Material and/or process substitution; (2) ventilated partial or full
enclosures; (3) local exhaust ventilation at the points of operation,
material handling, and transfer; or (4) process control, such as wet
methods and automation. Under proposed paragraph (f)(2)(i)(B), an
employer would be exempt from using the above controls to the extent
that: (1) The employer can establish that such controls are not
feasible; or (2) the employer can demonstrate that exposures are below
the action level, using no fewer than two representative personal
breathing zone samples taken 7 days apart, for each affected operation.
Because OSHA recognized that these proposed provisions are not
typical for OSHA standards, which usually require engineering controls
only where exposures exceed the PEL(s), the Agency asked for comments
on the potential benefits of including such provisions in the beryllium
standard, the potential costs and burdens associated with them, and
whether OSHA should include these provisions in the final standard (80
FR 47789). In addition, the Agency examined and asked for comment on
Regulatory Alternative #6, which would exclude the provisions of
proposed paragraph (f)(2)(i) from the final standard.
Comments on these provisions focused mainly on the trigger for
proposed paragraph (f)(2)(i) or the action level exemption in proposed
paragraph (f)(2)(i)(B)(2) and fell into one of two categories. The
first group of stakeholders argued that the engineering and work
practice controls requirement in proposed paragraph (f)(2)(i) was too
broad. Specifically, they objected to the inclusion of a requirement
for controls where exposures do not exceed the TWA PEL or STEL. For
example, NGK argued that "this provision essentially halves the PEL by
requiring engineering controls above the action level" (Document ID
1663, p. 2). NGK asserted that engineering controls should only be
required where exposures exceed the TWA PEL or STEL, concluding that
the "mandatory use of certain engineering controls" should be removed
(Document ID 1663, p. 4). Similarly, Ameren disagreed with the proposed
requirement to use at least one engineering control in areas where, it
stated, there may be only minimal exposures and thus no benefit to be
gained from installing additional controls (Document ID 1675, p. 5).
The second set of commenters argued that the engineering and work
practice controls requirement in proposed paragraph (f)(2)(i) was too
narrow. These commenters objected to the exemption in proposed
paragraph (f)(2)(i)(B)(2), which exempted employers from using one of
the controls listed in (f)(2)(i) to the extent that the employer could
demonstrate that exposures are below the action level, using no fewer
than two representative personal breathing zone samples taken 7 days
apart, for each affected operation. USW commented that the only
legitimate reasons not to require engineering controls below the action
level are if such a requirement is technologically or economically
infeasible (Document ID 1681, p. 10). The AFL-CIO and National COSH
similarly recommended that the final standard require engineering and
work practice controls wherever airborne beryllium is present (Document
ID 1689, p. 11; 1690, p. 3). The AFL-CIO based their recommendation on
the capacity of beryllium at very low concentrations to cause beryllium
sensitization and its carcinogenicity (Document ID 1689, p. 12).
OSHA has carefully reviewed the opinions and arguments of these
commenters, and has concluded that the requirement to implement at
least one form of exposure control on beryllium-releasing processes
will serve to reduce the significant risk of both CBD and lung cancer
remaining at the TWA PEL (see Section VII, Significance of Risk), and
will also reduce the likelihood of exposures exceeding the PEL in the
absence of any engineering or work practice control. OSHA therefore
disagrees with Ameren's argument that the requirements of (f)(2)(i)
will not benefit workers, and with NGK's position that engineering
controls should not be required below the TWA
PEL and STEL. OSHA also disagrees with NGK's characterization of the
list of controls provided in (f)(2)(i) as a "mandatory use of certain
engineering controls" (Document ID 1663, p. 4). Rather, the list
includes a broad range of possible approaches to eliminate, capture or
control beryllium emissions at the source so as to reduce employees'
exposure to airborne beryllium, and provides employers great
flexibility in selection of at least one such approach where required
by the standards.
However, while the Agency upholds the importance of requiring at
least one engineering or work practice control where operations release
beryllium, it disagrees with comments that such controls should be
required wherever there is airborne beryllium at any level. OSHA
recognizes that a significant risk of developing beryllium-related
adverse health effects remains at the action level. But the Agency
finds that an exemption from the requirement to implement at least one
of the controls listed in proposed paragraph (f)(2)(i)(A) when
exposures are demonstrably below the action level strikes a reasonable
balance between providing additional protection for employees who are
at risk and the burdens associated with implementing controls that may
provide little or no benefit (i.e., where airborne exposures are
minimal). The action level serves as a reasonable and administratively
convenient benchmark for a number of provisions in the standards (e.g.,
periodic exposure monitoring, medical surveillance); OSHA finds that
the action level serves a comparable purpose with regard to the
requirement to implement at least one of the controls listed in
proposed paragraph (f)(2)(i)(A) as well.
Moreover, as discussed in the NPRM, the inclusion of the
engineering and work practice control provision in proposed paragraph
(f)(2)(i)(A) addresses a concern regarding the proposed PEL. OSHA
expects that day-to-day changes in workplace conditions might cause
frequent excursions above the PEL in workplaces where periodic sampling
indicates exposures are between the action level and the PEL. Normal
variability in the workplace and work processes, such as workers'
positioning or patterns of airflow, can lead to excursions above the
PEL. Substitution or controls such as those outlined in proposed
paragraph (f)(2)(i)(A) provide the most reliable means to control
variability in exposure levels. And, as noted above, they have the
added benefit of further reducing beryllium exposures to employees
where such means are feasible, and so reducing the significant risk of
beryllium-related adverse health effects associated with airborne
exposures at the TWA PEL and the action level (see Section VII,
Significance of Risk). In addition, OSHA finds that the exemption in
proposed paragraph (f)(2)(i)(B)(2) will reduce the cost burden on
employers with operations where measured exposures are below the action
level, and therefore less likely to exceed the PEL in the course of
typical exposure fluctuations. OSHA notes that this exemption is
similar to a provision in 1,3-Butadiene (29 CFR 1910.1051), which
requires an exposure goal program where exposures exceed the action
level. Therefore, OSHA has retained the proposed provisions of
paragraph (f)(2)(i) and the proposed exemptions. The Agency also
revised the enumeration of the paragraphs for clarity in the final
standards.
OSHA has made a number of clarifying changes to the language of
proposed paragraph (f)(2)(i), none of which is meant to change the
meaning of the proposed language. First, OSHA revised the proposed
language of (f)(2)(i)(A) (paragraph (f)(2)(i) in the final standards)
by specifying that this provision applies to each operation in a
beryllium work area "that releases airborne beryllium." The proposed
language could have been interpreted to require controls on operations
that do not release airborne beryllium, if such operations happened to
be performed in a beryllium work area; it was not OSHA's intent to
require employers to apply controls to any operations that do not
release beryllium. Second, OSHA added the term "airborne" preceding
"exposure" in proposed (f)(2)(i)(A) and (f)(2)(i)(B)(2) (paragraphs
(f)(2)(i) and (f)(2)(ii)(B) in the final standards) to clarify the type
of exposure addressed by these provisions. Third, OSHA removed the
phrase "engineering and work practice controls" preceding the list of
controls provided in proposed paragraph (f)(2)(i)(A) (paragraph
(f)(2)(i) in the final standards) for brevity. Fourth, OSHA modified
the language of proposed paragraph (f)(2)(i)(A) (paragraph (f)(2)(i) in
the final standards) to require employers to "reduce", rather than
"minimize" airborne exposure because "reduce" is more consistent
with the requirement; employers are not required to implement more than
one such control unless exposures exceed the TWA PEL or STEL. OSHA has
included a non-mandatory appendix presenting a non-exhaustive list of
engineering controls employers may use to comply with paragraph
(f)(2)(i) (see Appendix A).
The fifth and sixth clarifying changes to proposed paragraph
(f)(2)(i) address the types of control measures that are acceptable for
complying with the provision. The Southern Company suggested that
isolation/containment should be considered for inclusion in the listed
controls in proposed paragraph (f)(2)(i)(A) (Document ID 1668, p. 5).
OSHA agrees that isolation is an appropriate method of exposure
control, and proposed paragraph (f)(2)(i)(A)(2) listed "ventilated
partial or full enclosures", which are forms of isolation. Paragraph
(f)(2)(i)(B) of the final standards indicates "isolation, such as
ventilated partial or full enclosures" to make clear that alternative
forms of isolation are also acceptable. In addition, USW and Materion
recommended that proposed paragraph (f)(2)(i)(A)(3), which read "local
exhaust ventilation at the points of operation, material handling, or
transfer" be revised to read "local exhaust ventilation such as at
the points of operation, material handling, or transfer" to broaden
the applicability of the provision (Document ID 1680, p. 4). OSHA
agrees that the suggested revision more accurately describes acceptable
control measures, and has adopted the recommended change in the final
standards (now designated as paragraph (f)(2)(i)(C)).
The seventh and final clarifying change to proposed paragraph
(f)(2)(i) pertains to the proposed requirement for employers to
demonstrate that airborne exposures are below the action level using
personal breathing zone samples taken 7 days apart. In response to a
comment from Ameren Corporation, which stated that some operations are
short in duration and taking samples precisely 7 days apart may not be
possible (Document ID 1675, p. 5), OSHA changed the text of the
standards to "at least 7 days apart", which was the Agency's
intention.
With these changes, final paragraph (f)(2)(i) of the general
industry standard requires that, for each operation in a beryllium work
area that releases airborne beryllium, the employer must ensure that at
least one of the following is in place to reduce airborne exposure: (A)
Material and/or process substitution; (B) isolation, such as ventilated
partial or full enclosures; (C) local exhaust ventilation, such as at
the points of operation, material handling, and transfer; or (D)
process control, such as wet methods and automation. Final paragraph
(f)(2)(ii) allows that an employer is exempt from using the above
controls to the extent that: (A) The employer can establish that such
controls are not feasible; or (B) the employer can demonstrate that
airborne exposure is below the action level, using
no fewer than two representative personal breathing zone samples taken
at least 7 days apart, for each affected operation.
Final paragraph (f)(2)(i) of the construction and shipyard
standards also requires employers to ensure that one of the four
enumerated types of control is in place to reduce airborne exposure and
exempts employers who can establish that such controls are not feasible
or demonstrate that airborne exposure is below the action level, using
no fewer than two representative personal breathing zone samples taken
at least seven days apart, for each affected operation. However, the
triggers in construction and shipyards differ from that in general
industry: whereas the general industry standard requires employers to
put one of the controls in place for each operation in a beryllium work
area that releases airborne beryllium, the construction and shipyard
standards do not require the establishment of beryllium work areas. In
lieu of that trigger, the construction and shipyard provision requires
the placement of a control where exposures are or can reasonably be
expected to be at or above the action level. OSHA selected the action
level as a trigger for this requirement because, as indicated above,
the Agency finds that an exemption from the requirement to implement at
least one of the controls is appropriate when exposures are below the
action level.
Congressman Robert C. Scott, Ranking Member of the House Committee
on Education and the Workforce, recommended that the final standards
should require abrasive blasting (the primary source of beryllium
exposure in construction and maritime) to be conducted within
containments whenever feasible (Document ID 1672, p. 4). OSHA agrees
that containment is an effective approach to limit exposures outside of
the blasting operation, and is protective of workers in nearby areas or
performing ancillary activities. However, because abrasive blasting is
performed in a wide variety of occupational settings and alternative
methods of exposure control (for example, use of wet methods) may be
effective in some settings, OSHA does not require the use of
containment whenever feasible in blasting operations. Rather, paragraph
(f)(2) is intended to provide employers flexibility to determine an
appropriate approach to maintain airborne exposures below the TWA PEL
and STEL and, in accordance with (f)(2)(i), reduce airborne exposures
that exceed the action level.
If exposures exceed the TWA PEL or STEL after the employer has
implemented the control(s) required by paragraph (f)(2)(i), paragraph
(f)(2)(iii) requires the employer to implement additional or enhanced
engineering and work practice controls to reduce exposures to or below
the PELs. For example, an enhanced engineering control may entail a
redesigned hood on a local exhaust ventilation system to more
effectively capture airborne beryllium at the source. The employer must
use engineering and work practice controls, to the extent that such
controls are feasible, to achieve the PELs.
Whenever the employer demonstrates that it is not feasible to
reduce exposures to or below the PELs using the engineering and work
practice controls required by paragraphs (f)(2)(i) and (f)(2)(iii),
however, paragraph (f)(2)(iv) requires the employer to implement and
maintain engineering and work practice controls to reduce exposures to
the lowest levels feasible and supplement these controls by using
respiratory protection in accordance with paragraph (g) of this
standard. As indicated previously, OSHA's long-standing hierarchy of
controls policy was supported by a number of commenters (e.g., Document
ID 1963, p. 12; 1655, pp. 8, 16; 1618, p. 8; 1689, p. 11; 1625, p. 6;
1664, p. 6). Paragraphs (f)(2)(iii) and (f)(2)(iv) in the final
standards are substantively consistent with the proposal, with minor
changes to clarify that the provisions address only airborne exposures,
and that paragraph (f)(2)(iii) applies to both the TWA PEL and STEL.
Finally, paragraph (f)(3) of the proposed rule would have
prohibited the employer from rotating workers to different jobs to
achieve compliance with the PELs. As explained in the NPRM, worker
rotation can potentially reduce exposures to individual employees, but
increases the number of employees exposed. Because OSHA has determined
that exposure to beryllium can result in sensitization, CBD, and
cancer, the Agency considers it inappropriate to place more workers at
risk. Since no absolute threshold has been established for
sensitization or resulting CBD or the carcinogenic effects of
beryllium, it was considered prudent to limit the number of workers
exposed at any concentration by prohibiting employee rotation.
This provision is not a general prohibition of worker rotation
wherever workers are exposed to beryllium. It is only intended to
restrict its use as a compliance method for the PEL (e.g., by exposing
twice as many workers to beryllium for half the amount of time). It is
not intended to bar the use of worker rotation as deemed appropriate by
the employer in activities such as to provide cross-training or to
allow workers to alternate physically demanding tasks with less
strenuous activities. This same provision is included in the standards
for asbestos (29 CFR 1910.1001 and 29 CFR 1926.1101), chromium (VI) (29
CFR 1910.1026), 1,3-butadiene (29 CFR 1910.1051), methylene chloride
(29 CFR 1910.1052), and cadmium (29 CFR 1910.1027 and 29 CFR
1926.1127), and methylenedianiline (29 CFR 1910.1050 and 29 CFR
1926.60). OSHA did not receive any objections to or comments on this
provision and includes it in all three of the final standards to limit
the number of employees at risk.
(g) Respiratory Protection
Paragraph (g) of the standard establishes the requirements for the
use of respiratory protection. Specifically, this paragraph requires
that employers provide respiratory protection at no cost to the
employee and ensure that employees utilize such protection during the
situations listed in paragraph (g)(1). As detailed in paragraph (g)(2),
the selection and use of required respiratory protection must comply
with OSHA's Respiratory Protection standard (29 CFR 1910.134). In
addition, paragraph (g)(3) requires employers to provide employees
entitled to respiratory protection with a powered air-purifying
respirator (PAPR) instead of a negative pressure respirator, if a PAPR
is requested by the employee.
Paragraph (g)(1) requires employers to ensure that each employee
required to use a respirator does so. Accordingly, simply providing
respirators to employees will not satisfy an employer's obligations
under paragraph (g)(1) unless the employer also ensures that each
employee properly wears the respirator when required. Paragraph (g)(1)
also requires employers to provide required respirators at no cost to
employees. This requirement is consistent with the OSH Act's holding
employers principally responsible for complying with OSHA standards,
with similar provisions under other OSHA standards, and specifically
with OSHA's Respiratory Protection standard, which also requires
employers to provide required respiratory protection to employees at no
cost (29 CFR 1910.134(c)(4)).
Paragraph (g)(1) requires appropriate respiratory protection during
certain enumerated situations. Paragraph (g)(1)(i) requires respiratory
protection during the installation and implementation of feasible
engineering
and/or work practice controls where airborne exposures exceed or can
reasonably be expected to exceed the TWA PEL or STEL. The Agency
understands that changing workplace conditions may require employers to
install new engineering controls, modify existing controls, or make
other workplace changes to reduce employee exposure to or below the TWA
PEL and STEL. In these cases, the Agency recognizes that installing
appropriate engineering controls and implementing proper work practices
may take time, and that exposures may be above the PELs until such work
is completed. See paragraph (g)(1)(ii), discussed below. During this
time, employers must demonstrate that they are making prompt, good
faith efforts to obtain and install appropriate engineering controls
and implement effective work practices, and to evaluate their
effectiveness for reducing airborne exposure to beryllium to or below
the TWA PEL and STEL.
Paragraph (g)(1)(ii) requires the provision and use of respiratory
protection during any operations, including maintenance and repair
operations and other non-routine tasks, when engineering and work
practice controls are not feasible and airborne exposures exceed or can
reasonably be expected to exceed the TWA PEL or STEL. OSHA included
this provision because the Agency realizes that certain operations may
take place when engineering and work practice controls are not
operational or capable of reducing exposures to or below the TWA PEL
and STEL. The installation of necessary engineering controls, covered
by paragraph (g)(1)(i), is a particular example of this more general
circumstance. For another example, during maintenance and repair
operations, engineering controls may lose their full effectiveness or
require partial or total breach, bypass, or shutdown. Under these
circumstances, if exposures exceed or can reasonably be expected to
exceed the TWA PEL or STEL, the employer must provide and ensure the
use of respiratory protection.
Paragraph (g)(1)(iii) requires the provision and use of respiratory
protection where beryllium exposures exceed the TWA PEL or STEL, even
after the employer has installed and implemented all feasible
engineering and work practice controls. OSHA anticipates that there
will be some situations where feasible engineering and work practice
controls are insufficient to reduce airborne exposure to beryllium to
levels at or below the TWA PEL or STEL (see this preamble at section
VIII.D, Technological Feasibility). In such cases, the standard
requires that employers implement and maintain engineering and work
practice controls to reduce exposure to the lowest levels feasible and
supplement those controls by providing respiratory protection
(paragraph (f)(2)(iv)). OSHA emphasizes that even where employers are
able to demonstrate that engineering and work practice controls are not
feasible or sufficient to reduce exposure to levels at or below the TWA
PEL and STEL the use of respirators to achieve the PELs is only a
supplement, and not a substitute for, such "lowest level feasible"
controls.
Paragraph (g)(1)(iv) requires the provision and use of respiratory
protection in emergencies. Under the final standards, an emergency is
defined as "any uncontrolled release of airborne beryllium" (see
paragraph (b) of the standards). During emergencies, engineering
controls may not be functioning fully or may be overwhelmed or rendered
inoperable. Also, emergencies may occur in areas where there are no
engineering controls. The standard recognizes that the provision of
respiratory protection is critical in emergencies, as beryllium
exposures may be very high and engineering controls may not be adequate
to control an unexpected release of airborne beryllium.
Boeing suggested limiting requirement of respirator use triggered
by this definition of emergency, as it would not be practical to
provide respirators to and train the large number of employees in the
event of a fire or explosion (Document ID 1667, pp. 4-5). OSHA wishes
to clarify that paragraph (g)(1)(iv) is not intended to require
employers to provide respirators to all employees who may pass through
areas where beryllium-releasing processes are housed, in the event of a
general evacuation due to an event such as a fire or explosion. Rather,
in the event that an uncontrolled release of beryllium occurs
(f)(1)(iv) requires employers to provide respirators to employees who
work in the vicinity of beryllium-releasing processes and employees who
respond to such an emergency, because these employees will be in the
immediate vicinity of an uncontrolled release.
Paragraph (g)(1)(v) requires the provision and use of respiratory
protection when an employee who is eligible for medical removal under
paragraph (l)(1) chooses to remain in a job with airborne exposure at
or above the action level. As explained in the summary and explanation
of paragraph (l), Medical Removal Protection, an employee who is
diagnosed with CBD or confirmed positive for beryllium sensitization
and who works in a job with airborne exposure at or above the action
level is eligible for medical removal protection (MRP). An employee who
is eligible for MRP may choose medical removal from jobs with exposure
at or above the action level, or may choose to remain in a job with
exposure at or above the action level provided that the employee uses
respiratory protection in accordance with the provisions of this
paragraph (g), Respiratory Protection. This provision was not included
in the proposed standard. However, OSHA received comments emphasizing
the importance of reducing or eliminating the exposure of sensitized
employees. For example, National Jewish Health (NJH) stated that
"removal from exposure is the best form of prevention" (Document ID
1664, p. 4). The United Steelworkers (USW) commented that workers who
are sensitized to beryllium or are in the early stages of chronic
beryllium disease can significantly benefit from a reduction in their
exposure to beryllium, based on evidence reviewed in Section VIII
(Significant Risk) of the NPRM (Document ID 1963, p. 13). OSHA is
cognizant that employees who are MRP-eligible (i.e., confirmed positive
for beryllium sensitization or diagnosed with CBD) may decide not to
take medical removal protection (MRP) or otherwise alert the employer
to their condition. Therefore, OSHA included paragraph (g)(1)(v) in the
final standards to provide these employees access to respiratory
protection if their airborne exposures are expected to be at or above
the action level. While not as protective as removal from any beryllium
exposure, NJH's comments indicate that such protection has the
potential to delay or avoid the onset of CBD in sensitized individuals
and to mitigate or retard the effects of CBD in employees who are in
the early stages of CBD. Because OSHA has not made a finding of
significant risk at exposure levels below the action level, OSHA has
chosen not to require provision and use of respirators for employees
exposed below the action level, including sensitized employees.
However, OSHA does not assume the absence of risk below the action
level, especially to this particularly vulnerable population Indeed, it
is the Agency's recommendation that employers voluntarily provide such
protection to employees who self-identify that they have tested
positive for sensitization if they ask for it and will be exposed to
beryllium below the action level, or for whom a licensed physician has
recommended such protection. OSHA intends to issue additional guidance
regarding non-mandatory respiratory protection for this group of at-
risk employees along with other compliance guidance in connection with
these standards.
OSHA received no comments objecting to paragraph (g)(1). Therefore,
except for minor edits for clarity explained in the introduction to
this section, it is unchanged from the proposal.
Whenever respirators are used to comply with the requirements of
this standard, paragraph (g)(2) requires that the employer implement a
comprehensive written respiratory protection program in accordance with
OSHA's Respiratory Protection standard (29 CFR 1910.134). The
Respiratory Protection standard is designed to ensure that employers
properly select and use respiratory protection in a manner that
effectively protects exposed employees. Under 29 CFR 1910.134(c)(1),
the employer's respiratory protection program must include:
Procedures for selecting appropriate respirators for use
in the workplace;
Medical evaluations of employees required to use
respirators;
Respirator fit testing procedures for tight-fitting
respirators;
Procedures for proper use of respirators in routine and
reasonably foreseeable emergency situations;
Procedures and schedules for cleaning, disinfecting,
storing, inspecting, repairing, discarding, and otherwise maintaining
respirators;
Procedures to ensure adequate quality, quantity, and flow
of breathing air for atmosphere-supplying respirators;
Training of employees in the respiratory hazards to which
they are potentially exposed during routine and emergency situations,
and in the proper use of respirators; and
Procedures for evaluating the effectiveness of the
program.
In accordance with OSHA's policy to avoid duplication and to
establish regulatory consistency, paragraph (g)(2) incorporates by
reference the requirements of 29 CFR 1910.134 rather than reprinting
those requirements in this standard. OSHA notes that the respirator
selection provisions in 29 CFR 1910.134 include requirements for
Assigned Protection Factors (APFs) and Maximum Use Concentrations
(MUCs) that OSHA adopted in 2006 (71 FR 50122 (Aug. 24, 2006)). The
APFs and MUCs provide employers with critical information for the
selection of respirators to protect workers from exposure to
atmospheric workplace contaminants. In incorporating the Respiratory
Protection standard by reference, OSHA intends that any future change
to that standard will automatically apply to this standard as well. As
appropriate, OSHA will note the intended effect on this standard (and
other standards) in either the text or preamble of the amended
Respiratory Protection standard, but does not anticipate the need for a
conforming amendment to this standard.
Moreover, the situations in which respiratory protection is
required under these standards are generally consistent with the
requirements in other OSHA health standards, such as those for chromium
(VI) (29 CFR 1910.1026), butadiene (29 CFR 1910.1051), and methylene
chloride (29 CFR 1910.1052). Those standards and this standard also
reflect the Agency's traditional adherence to a hierarchy of controls
in which engineering and work practice controls are preferred to
respiratory protection (see the discussion of paragraph (f) earlier in
this section of the preamble).
OSHA received no comments objecting to paragraph (g)(2). OSHA added
language to clarify that both the selection and use of respiratory
protection must be in accordance with the Respiratory Protection
standard. Other than that change and some minor edits for clarity,
paragraph (g)(2) is unchanged from the proposal.
Paragraph (g)(3) requires the employer to provide a powered air-
purifying respirator (PAPR) instead of a negative pressure respirator
at no cost to the employee when an employee entitled to respiratory
protection under (g)(1) of these standards requests a PAPR. The
employee may select any form of PAPR (half mask, full facepiece,
helmet/hood, or loose fitting facepiece), so long as the PAPR is
selected and used in compliance with the Respiratory Protection
standard (29 CFR 1910.134) and provides adequate protection to the
employee in accordance with paragraph (g)(2) of these standards. For
example if an employee is using a half mask respirator with an APF of
10 then a loose fitting PAPR with an APF of 25 would be an appropriate
alternative. However, if the employee is required to use a full face
respirator with an APF of 50 then the appropriate PAPR alternative
would be a tight fitting PAPR.
The requirement to provide a PAPR upon request of the employee
(paragraph (g)(3)) is similar to provisions in several previous OSHA
standards, including inorganic arsenic (CFR 1910.1018), lead (CFR
1910.1025), cotton dust (1910.1043), asbestos (CFR 1910.1001), and
cadmium (1910.1027). In promulgating these standards, OSHA cited
several reasons why PAPRs can provide employees with better protection
than negative pressure respirators, including superior reliability and
comfort, reduced interference with work processes, and superior
protection, especially for employees who cannot obtain a good face fit
with a negative pressure respirator (e.g., 43 FR 19584, 19619; 43 FR
52952, 52993; 51 FR 22612, 22698). Based on these considerations, OSHA
required employers to provide PAPRs upon request to facilitate
consistent and effective use of respiratory protection by employees
when needed, and particularly in situations where respirator use is
required for long periods of time (see 43 FR 52952, 52993; 51 FR 22612,
22698).
The PAPR provision was not included in the proposed standard.
However, OSHA solicited public comment on the issue of whether
employers should be required to provide employees with PAPRs upon
request. During the public comment period and public hearing for the
beryllium NPRM, several commenters supported a requirement for
employers to provide a PAPR upon an employee's request, including the
Sampling and Analysis Subcommittee Task Group of the Beryllium Health
and Safety Committee (BHSC Task Group) (Document ID 1655, p. 8), a
representative of the Department of Defense (Document ID 1684,
Attachment 2, p. 4), ORCHSE Strategies (ORCHSE) (Document ID 1691, p.
4), NJH (Document ID 1664, p. 5), Kimberly-Clark Professional (KCP)
(Document ID 1676, p. 3), and North America's Building Trades Unions
(NABTU) (Document ID 1679, p. 9). Dr. Lisa Maier of the NJH stated,
"The beryllium standard should require employers to provide PAPRs when
requested by the employee. We have consulted with clients on
respiratory protection for beryllium exposure and found that employees
are more likely to comply with respiratory protection requirements when
they have an option regarding the type of respirator they wear"
(Document ID 1664, p. 7). Joann Kline of KCP similarly commented that
"[f]it, style, comfort and worker preference are significant factors
in the effectiveness of protection . . . Allowing a worker to choose
PPE, including PAPRs, makes it much more likely that it will be
comfortable and accepted. PAPRs in particular add to worker comfort,
especially in hot environments, because of the flow of
fresh air on and around the wearer's face" (Document ID 1676, p. 3).
Likewise, ORCHSE commented that "[c]omfort is a significant factor
in the ability of employees to wear respiratory protection
consistently, especially during an entire work shift, and/or under hot
or stressful conditions. Employees experiencing discomfort, which is
likely with negative-pressure respirators, are more apt to remove or
otherwise compromise the effectiveness of their respirators while in
the workplace. It is thus prudent for employers to provide the type of
respiratory protection employees are more likely to use consistently
and correctly" (Document 1691, p. 4). Chris Trahan of NABTU cited the
susceptibility of some employees to beryllium sensitization as a reason
to require employers to provide PAPRs to employees upon their request
(Document ID 1679, p. 9). As discussed in Section V, some individuals
are genetically susceptible to beryllium-induced sensitization and CBD,
and may develop these conditions from exposure to beryllium at levels
well below the PEL and STEL included in this standard. Genetically
susceptible individuals may therefore benefit from the enhanced
protection provided by a PAPR, which have APFs ranging from 50 to 1000
depending on type.
OSHA also received comments opposing a requirement for employers to
provide PAPRs upon employee request. For example, Julie A. Tremblay of
3M commented that the incorporation of the Respiratory Protection
Standard (29 CFR 1910.134) by reference, particularly paragraph
(d)(1)(i) and paragraph (e)(6)(ii), adequately addresses issues of
appropriate respirator selection (Document ID 1625, Attachment 1, p.
2). 1910.134(d)(1)(i) directs the employer to select and provide an
appropriate respirator based on the respiratory hazard(s) to which the
worker is exposed and workplace and user factors that affect respirator
performance and reliability. 1910.134(e)(6)(ii) states that if the
PLHCP finds a medical condition that may place the employee's health at
increased risk if a negative pressure respirator is used, the employer
shall provide a PAPR if the PLHCP's medical evaluation finds that the
employee can use such a respirator; however, if a subsequent medical
evaluation finds that the employee is medically able to use a negative
pressure respirator, then the employer is no longer required to provide
a PAPR. OSHA received a similar comment from Charlie Shaw of Southern
Company (Document ID 1668, p. 5). Two other commenters, William Orr of
Ameren Corporation (Ameren) and Daniel Shipp of the International
Safety Equipment Association (ISEA), stated that respiratory protection
selection should be based primarily on the required APF given the
exposure concentration of beryllium (Document ID 1675, p. 12; 1682, p.
1). However, Mr. Orr also commented that workers handling beryllium-
containing materials should have access to loose fitting respirators
for added dermal protection so long as the respirator's APF is
appropriate to the work performed (Document ID 1675, p. 12). Mr. Orr
also argued that a PAPR option is not necessary in the beryllium
context: "A PAPR should only be required if the exposure level
dictates that the protection of a PAPR is necessary. The level of
protection in the asbestos standard (CFR 1910.1001) is applicable to
protection from airborne fibers with the unique characteristics of
asbestos. The level of protection for beryllium should closer resemble
particulate metal protection such as seen in the standards for metals
such as lead or hexavalent chromium" (Document ID 1675, p. 12). (As
discussed above, the Agency notes that the OSHA lead standard (CFR
1910.1025) does include a PAPR requirement, as does the standard for
cadmium (1910.1027), also a metal).
Finally, OSHA received a comment from USW (Document ID 1681)
recommending that OSHA limit the type of PAPR provided under (g)(3) to
types with close-fitting facepieces. USW stated that "[t]he types with
close-fitting face pieces can be quite effective, but it is easy to
over breathe other types, especially the loose-fitting helmets"
(Document ID 1681, p. 22).
OSHA has carefully considered all comments received on the issue of
requiring employers to provide employees with PAPRs upon request, and
agrees with Dr. Maier of NJH, Ms. Trahan of NABTU, and other commenters
who have argued that providing employees a choice in selection of
respiratory protection will improve the effectiveness of respiratory
protection in reducing risk of sensitization and disease from
occupational beryllium exposure. While the provisions of the
Respiratory Protection standard provide important baseline requirements
appropriate to all situations where respiratory protection is required,
as discussed above, OSHA recognizes that provisions beyond those of the
Respiratory Protection standard are appropriate in some circumstances
to ensure that required respiratory protection is used on a consistent
basis and as effectively as possible. As discussed in section V, Health
Effects and section VI, Risk Assessment of this preamble, beryllium
sensitization and CBD can result from small, short-term beryllium
exposure in some individuals. Accordingly, consistent and effective
respirator usage has played an important role in minimizing risk among
workers in occupational settings such as beryllium processing, where it
has proven difficult to reduce airborne exposures below 0.2 µg/
m3\ using engineering controls. Based on this evidence, OSHA concludes
that provision of PAPRs at the employee's request will provide
employees necessary protection beyond that found in provisions of the
Respiratory Protection standard, where provision of a PAPR for reasons
of fit, comfort and reliability is at the employer's discretion.
Contrary to the comments of Mr. Orr and Mr. Shipp cited above, the
evidence that beryllium sensitization can result from short-term, low-
level airborne beryllium exposure supports the provision of PAPRs upon
request rather than relying on APF alone. Finally, while OSHA agrees
with the USW that PAPRs with close-fitting facepieces can be more
effective than loose-fitting helmets, the Agency recognizes that loose-
fitting helmets may be required in certain work conditions or due to
difficulty achieving proper fit for some workers. Therefore, the
standards allow for selection of any type of PAPR, but require that the
PAPR selected provide adequate protection to the employee in accordance
with the Respiratory Protection standard.
(h) Personal Protective Clothing and Equipment
Paragraph (h) of the standards requires employers to provide
employees with personal protective clothing and equipment (PPE) where
employee exposure exceeds or can reasonably be expected to exceed the
TWA PEL or STEL and where there is reasonable expectation of dermal
contact with beryllium. Paragraph (h) also contains provisions for the
safe removal, storage, cleaning, and replacement of the PPE required by
the standards. To protect employees from adverse health effects, these
PPE requirements are intended to prevent dermal exposure to beryllium,
and prevent the accumulation of airborne beryllium on clothing, shoes,
and equipment, which can result in additional inhalation exposure. The
requirements also protect employees in other work areas, as well as
employees and other individuals outside the workplace, from exposures
that could occur if contaminated clothing were to transfer beryllium to
those areas. The standards require the employer to
provide PPE at no cost to employees, and to ensure that employees use
the provided PPE in accordance with the written exposure control plan
as described in paragraph (f)(1) of these standards and OSHA'S Personal
Protective Equipment standards (29 CFR part 1910 Subpart I, 29 CFR part
1926 Subpart E, and 29 CFR part 1915 Subpart I). PPE, as used in the
description of paragraph (h), refers to both clothing and equipment
used to protect an employee from either airborne exposure to or dermal
contact with beryllium. The requirements in paragraph (h) are the same
in general industry, construction, and shipyards, except for the
references to OSHA's Personal Protective and Life Saving Equipment
standard for construction (29 CFR part 1926 Subpart E) in the
construction standard and OSHA's Personal Protective Equipment standard
for shipyards (29 CFR part 1915 Subpart I) in the shipyard standard.
Requiring PPE is consistent with section 6(b)(7) of the OSH Act, which
states that, where appropriate, standards shall prescribe suitable
protective equipment to be used in connection with hazards (29 U.S.C.
655(b)(7)). The requirements for PPE are based upon widely accepted
principles and conventional practices of industrial hygiene, and are
similar to the PPE requirements in other OSHA health standards, such as
chromium (VI) (29 CFR 1910.1026), lead (29 CFR 1910.1025), cadmium (29
CFR 1910.1027), and methylenedianiline (MDA; 29 CFR 1910.1050).
The final provisions in paragraph (h) are the same as the proposed
provisions, with several exceptions. First, in the final standards OSHA
has used the term "contact" instead of "exposure" where the
standards refer to the skin, so as to distinguish clearly between
exposure via the skin (dermal route) and the inhalation route of
exposure in the regulatory text. Second, OSHA has deleted the proposed
provision in paragraph (h)(1)(ii) requiring PPE where employees' skin
may become "visibly contaminated" with beryllium and instead will
require use of PPE whenever there is a reasonable expectation of dermal
contact with beryllium. Third, the final standards' requirements for
provision and use of PPE apply where employees may reasonably be
expected to have dermal contact with beryllium regardless of whether
the beryllium is in a soluble or poorly soluble (sometimes called
`insoluble') form, instead of just soluble beryllium compounds as in
proposed paragraph (h)(1)(iii). Fourth, paragraph (h)(2)(iii) now
requires that storage facilities for PPE prevent cross contamination.
Finally, OSHA has made a few minor changes to clarify or streamline the
regulatory text. The comments and OSHA's reasoning leading to these
changes are discussed below.
Paragraph (h)(1)(i) requires the provision and use of PPE for
employees exposed to any form of airborne beryllium above the TWA PEL
or STEL, or where exposure can reasonably be expected to exceed the TWA
PEL or STEL, because such exposure would likely result in skin contact
by means of deposits on employees' skin or clothes or on surfaces
touched by employees. The term "reasonably be expected" is intended
to convey OSHA's intent that the requirement for provision and use of
PPE is defined by an employee's potential exposure, not by any
particular individual's actual exposure. For example, if one employee's
exposure assessment results indicate that the employee's exposure is
above the PEL, it would be reasonable to expect that another employee
doing a similar task would have exposures above the PEL and thus would
require PPE.
Paragraph (h)(1)(ii) requires the provision and use of PPE where
employees are reasonably expected to have dermal contact with
beryllium. This requirement applies to beryllium-containing dust,
liquid, abrasive blasting media, and other beryllium-containing
materials that can penetrate the skin, regardless of the level of
airborne exposure. It is not intended to apply to dermal contact with
solid objects (for example, tools made of beryllium alloy) unless the
surface of such objects is contaminated with beryllium in a form that
can penetrate the skin. Dermal contact with beryllium can result in
absorption of beryllium through the skin and induce sensitization, a
necessary precursor to CBD, as discussed further in Health Effects,
section V.A.2.
As mentioned above, the requirements of paragraph (h)(1) of the
final standards differ from those of the proposed standard. Paragraph
(h)(1) of the proposed standard required employers to provide employees
with PPE where employee exposure exceeds or can reasonably be expected
to exceed the TWA PEL or STEL; where work clothing or skin may become
visibly contaminated with beryllium, including during maintenance and
repair activities or during non-routine tasks; and where employees'
skin is reasonably expected to be exposed to soluble beryllium
compounds. In the NPRM, OSHA discussed concerns with the proposed
requirements, requested public comment on proposed paragraph (h)(1),
and presented Regulatory Alternative 13. Alternative 13, as described
by OSHA, would replace the requirement for PPE where there is visible
contamination with a requirement for appropriate PPE wherever there is
potential for skin contact with beryllium or beryllium-contaminated
surfaces. OSHA requested comments on this alternative, including the
benefits and drawbacks of a broader PPE requirement and any relevant
data or studies the Agency should consider. As discussed below, OSHA
adopted Regulatory Alternative 13 in the final standard based on
comments received in the public comment period and public hearing and
on the scientific evidence in the record.
The proposed requirement to use PPE where clothing or skin may
become "visibly contaminated" with beryllium was a departure from
most OSHA standards, which do not specify that contamination must be
visible in order for PPE to be required. For example, the standard for
chromium (VI) (29 CFR 1910.1026) requires the employer to provide
appropriate PPE where a hazard is present or is likely to be present
from skin or eye contact with chromium (VI). The lead (29 CFR
1910.1025) and cadmium (29 CFR 1910.127) standards require PPE where
employees are exposed above the PEL or where there is potential for
skin or eye irritation regardless of airborne exposure level. In the
case of MDA (29 CFR 1910.1050), PPE must be provided where employees
are subject to dermal exposure to MDA, where liquids containing MDA can
be splashed into the eyes, or where airborne concentrations of MDA are
in excess of the PEL. While OSHA's language regarding PPE requirements
varies somewhat from standard to standard, previous standards emphasize
the potential for contact with a substance that can cause health
effects via dermal exposure, and do not condition the provision and use
of PPE on visible contamination with the substance.
Nearly all comments OSHA received on the proposed requirement for
employers to provide PPE where work clothing or skin may become
"visibly contaminated" with beryllium stated that this provision
would not be sufficiently protective of beryllium-exposed workers
(Document ID 1615, p. 8; 1625, p. 2; 1655, pp. 9-10; 1658, p. 6; 1664,
pp. 3-4; 1671, Attachment 1, p. 7; 1676, pp. 2-3; 1677, p. 2; 1679, p.
9; 1685, p. 3; 1688, p. 3; 1689, p. 12; 1691, pp. 4-5). Dr. Paul
Schulte of NIOSH stated that "visibly contaminated" is not
an appropriate trigger for PPE requirements, citing evidence from Day
et al. (2007, Document ID 1548) that biologically relevant amounts of
beryllium can accumulate on the skin without becoming visible, and
evidence from Armstrong et al. (2014, Document ID 0502) that work
surfaces in beryllium manufacturing facilities are typically
contaminated with beryllium even where airborne exposures are low
(Document ID 1671, Attachment 1, p. 7). Dr. Lisa Maier of NJH
commented, " `[v]isibly contaminated' is not an appropriate trigger
for PPE requirements; as noted by OSHA, `small particles may not be
visible to the naked eye' and as such PPE to protect from skin exposure
should be worn for all tasks where there is potential for skin contact
with beryllium particles" (Document ID 1664, pp. 3-4). Dr. Atul
Malhotra of the American Thoracic Society (ATS) stated that "the use
of `visibly contaminated' as a trigger for PPE is problematic for
multiple reasons . . . visual inspection cannot accurately estimate the
amount of beryllium or its chemical state. Use of `visibly
contaminated' is also not supported by the literature cited, which
demonstrates skin exposure and sensitization in work settings
considered clean, with no visible contamination" (Document ID 1688, p.
3).
In addition, some comments and testimony indicated that the term
"visibly contaminated" is ambiguous and likely to be confusing to
employers and others responsible for implementing the PPE requirements
of the beryllium standards. According to Mr. Daniel Shipp of the
International Safety Equipment Association (ISEA), " `[v]isible
contamination' is not an appropriate trigger for PPE. This term is too
subjective to be useful" (Document ID 1682, p. 2).
Based on its evaluation of the evidence in the record, OSHA agrees
with the commenters on these points. The Agency has determined that
contact with and absorption of even minute amounts of beryllium through
the skin may cause beryllium sensitization (see section V, Health
Effects, subsection 2, Dermal Exposure) and that a "visibly
contaminated" standard could allow for too much dermal exposure and be
insufficiently protective of workers. In addition, as discussed in
Section VI, Risk Assessment, studies conducted jointly by NIOSH and
Materion Corporation (Materion) showed that a comprehensive approach to
PPE is key to reducing risk of sensitization even in facilities that
implement stringent exposure control and housekeeping programs (See
Section VI. Risk Assessment).
Materion, whose joint submission with the United Steelworkers union
of a proposed standard was the basis for the "visibly contaminated"
language, discussed the use of the term in its post hearing comments
(Document ID 1808, pp. 4-5). Materion indicated that the typical
workplace cannot reasonably be expected to measure skin or surface
contamination for the purpose of determining whether PPE use is
necessary. Even if this was done, "such measures are lagging metrics
which, by definition, are post potential exposure" (Document ID 1808,
p. 5). Materion believed that a standard relying on visual cues to
check for contamination is easily understood by workers and management
and is a useful part of a beryllium worker protection model.
OSHA has considered Materion's comments supporting use of the terms
"visibly contaminated" and "visibly clean." The Agency finds that
the provision in the final standard requiring PPE wherever there is a
reasonable expectation of any dermal contact with beryllium more
clearly conveys to employers the idea that the provision and use of PPE
should be used as a precaution against potential dermal contact. OSHA
believes the proposed requirements for PPE where clothing or skin may
become "visibly contaminated" may be reasonably interpreted by
employers to mean that PPE is only required where work processes
release quantities of beryllium sufficient to create deposits visible
to the naked eye. If this were the case, employers' provision of PPE to
employees would certainly lag behind potential exposure, if such
provision occurs at all. Additionally, National Jewish Health agreed
with OSHA that small particles may not be visible to the naked eye
(Document ID 1664 p. 4). Therefore, OSHA has determined that the
language of the final standards is more easily understood and applied
so as to preempt dermal contact with beryllium and therefore prevent
adverse health effects caused by dermal contact, such as beryllium
sensitization. OSHA also notes that employers are not required to
measure skin or surface contamination under the provisions governing
the use and handling of PPE. Thus the Agency concludes that the changes
made to the proposed rule adequately address Materion's concerns and
more closely express OSHA's intent.
OSHA also requested comment on proposed paragraph (h)(1)'s
requirement for PPE to limit dermal contact with soluble beryllium
compounds, and whether employers should also be required to provide PPE
to limit dermal contact with poorly soluble (referred to as insoluble
in the proposal) forms of beryllium. The solubility of beryllium was a
consideration in the PPE requirements of the proposed standard because
dermal absorption may occur at a greater rate for soluble beryllium
than for poorly soluble beryllium.
Comments submitted on the topic of beryllium solubility and dermal
absorption indicate that beryllium in poorly soluble forms, as well as
soluble forms, can be absorbed through the skin and cause sensitization
(Document ID 1664, p. 3; 1671, p. 7; 1688, p. 3). Dr. Schulte of NIOSH
stated that PPE should be required to protect against exposure to
poorly soluble compounds as these forms can produce soluble beryllium
ions in sweat, and because beryllium in any form can enter the body
through minor abrasions, which are commonly found on the skin of
industrial employees (Document ID 1671, p. 7). (See further discussion
in Section V, Health Effects, subsection 2, Dermal Exposure.)
General comments on whether OSHA should adopt more comprehensive
PPE requirements similar to those specified in Regulatory Alternative
13 were, by and large, supportive. The Sampling and Analysis
Subcommittee Task Group of the Beryllium Health and Safety Committee
(BHSC Task Group) (Document ID 1655, pp. 16-17), NJH (Document ID 1664,
pp. 3-4, 7), NIOSH (Document ID 1671, p. 7), Kimberly-Clark
Professional (KCP) (Document ID 1676, p. 2), the DOE's National
Supplemental Screening Program (NSSP) (Document ID 1677, p. 2), ISEA
(Document ID 1682, p. 2), the American College of Occupational and
Environmental Medicine (ACOEM) (Document ID 1685, p. 3), ATS (Document
ID 1688, p. 3), the AFL-CIO (Document ID 1689, p. 12), and ORCHSE
Strategies (ORCHSE) (Document ID 1691, p. 4) all urged OSHA to adopt
Regulatory Alternative 13 or similar requirements. The BHSC Task Group
commented that its experience at Department of Energy Sites "strongly
suggests that this alternative should be adopted, since the concept of
`visibly contaminated' is not sufficient to ensure an absence of such
contamination on the skin" (Document ID 1655, p. 17). In addition, the
BHSC Task Group noted that elimination of dermal contact with beryllium
helps reduce the risk of sensitization (Document ID 1655, p. 17).
Similarly, several commenters indicated that a more appropriate
trigger for the provision and use of PPE under
paragraph (h)(1) would be whenever an employee has the potential for
skin contact with beryllium (Document ID 1664, p. 3; 1671, Attachment
1, p. 7; 1676, pp. 2-3). Dr. Lisa Maier from NJH indicated, in her
testimony, that "personal protective equipment (PPE) such as gloves,
respirators, protective clothing should be used wherever there is a
potential for respiratory or skin exposure" (Document ID 1720 p. 6).
Another commenter "strongly recommend[ed] a PPE requirement wherever
exposure to beryllium, soluble or insoluble, is reasonably expected"
(Kimberly-Clark Professional, Document ID 1676, p. 3).
In contrast, Ameren Corporation (Ameren) and NGK Metals (NGK)
recommended against adoption of Regulatory Alternative 13. According to
Ameren, "[t]race beryllium in fly ash is unlikely to cause
sensitization issues but PPE would be required under this alternative"
(Document ID 1675, p. 6). Ameren, however, did not provide further
information or evidence to support this claim. NGK suggested the
language "visibly contaminated with beryllium particulate or
solutions" as a trigger for the standards' PPE requirements, to
clarify that PPE is not required when handling clean, solid materials
that contain beryllium (Document ID 1663, pp. 2, 5). OSHA does not find
these comments persuasive. OSHA included operations and industries
where beryllium is present as a trace contaminant in the scope of the
beryllium standard only when these operations and industries have the
potential to release airborne exposures exceeding the action level of
0.1 μg/m3\, at which sensitization is known to occur (see Section
VI, Risk Assessment). With regard to NGK's suggested language, the
Agency believes the commenter's intention to clarify OSHA's position on
clean, solid materials is already captured in the regulatory text of
the standards. Paragraph (h)(1)(ii) is not intended to require the
provision of PPE to employees whose only contact with beryllium is
handling articles that do not have surface contamination with
beryllium.
In summary, OSHA has concluded that beryllium surface contamination
may not be visible yet may still cause sensitization. Because small
beryllium particles can pass through intact or broken skin and cause
sensitization, limiting the requirements for PPE based on surfaces that
are "visibly contaminated" may not adequately protect workers from
beryllium exposure. Submicron particles (less than 1 μg in diameter)
are not visible to the naked eye and yet may pass through the skin and
cause beryllium sensitization. And although solubility may play a role
in the level of sensitization risk, the available evidence indicates
that contact with poorly soluble as well as soluble beryllium can cause
sensitization via dermal contact (see this preamble at section V,
Health Effects). Based on these considerations, OSHA has adopted
Regulatory Alternative 13 in paragraph (h)(1)(ii) of the final
standards, which requires the employer to provide PPE and ensure its
use wherever there is a reasonable expectation of dermal contact with
beryllium to any extent and of any type.
The USW recommended further specification of the PPE provisions,
requesting clarification of the terms "skin" and "exposure" in the
proposed standard's PPE requirements (Document ID 1680, p. 4; 1681, p.
12). As discussed previously, the term "contact" has replaced
"exposure" where the final standard refers to the skin. This change
was made in order to clearly distinguish between airborne and contact
exposure in the text of the standards. OSHA's intention in using the
term "contact" is straightforward, meaning any instance in which
beryllium touches an employee's body. "Skin" refers to the exterior
surface of all parts of an employee's body including face, arms, scalp,
ears, and nostrils. OSHA notes that processes that have the potential
to expose workers' eyes to beryllium will generally also expose the
face, and forms of PPE such as face shields used to protect the face
generally also protect the eyes (e.g., face shields for use in
situations where there is a danger of being splashed in the face with
beryllium-containing liquid, or a hooded respirator where the employee
is exposed to beryllium-containing fumes).
The USW also requested that OSHA include a specific requirement for
provision of PPE to workers performing maintenance and repair
activities and during non-routine tasks, to ensure that PPE is worn
during tasks for which airborne exposure levels are not assessed
(Document ID 1680, pp. 4-5; 1681, p. 12). This comment was submitted in
response to the proposed standard, which would have required PPE where
airborne exposures exceed the TWA PEL or STEL, but not in all cases
where dermal contact occurs and airborne exposure levels are lower.
OSHA believes the USW's concern has been addressed by the PPE
requirements of the final standards, which apply wherever there is
reasonable expectation of dermal contact with beryllium, including
during maintenance and repair activities and non-routine tasks that
involve beryllium-releasing processes or that are conducted in
beryllium-contaminated areas.
OSHA also received a suggestion from the Boeing Company (Boeing) to
amend proposed paragraph (h)(1)'s requirement to ensure use of
appropriate PPE in accordance with the written exposure control plan,
by adding "or equally as effective documentation" (Document ID 1667,
p. 5). Boeing argued that the suggested language would allow employers
to provide the required information through use of existing processes
instead of through the creation of a second document (Document ID 1667,
pp. 3-5). OSHA considered Boeing's comment, but decided against adding
the suggested language. OSHA determined that it would create
unnecessary ambiguity in the requirements for documentation in the
context of both compliance and enforcement, as employers and CSHOs
would need to determine what constitutes "equally effective
documentation." If an employer such as Boeing already has documents
describing appropriate use of PPE that comply with the requirements of
these standards, OSHA believes those documents can easily be
incorporated into the employer's written exposure control plan. Taking
this approach would eliminate the potential for confusion or redundancy
caused by implementing multiple documents on PPE.
The employer must exercise reasonable judgment in selecting
appropriate PPE. This requirement is consistent with OSHA's current
standards for provision of personal protective equipment for general
industry (29 CFR part 1910 Subpart I), construction (29 CFR part 1926
Subpart E), and shipyards (29 CFR part 1915 Subpart I). As described in
the non-mandatory appendix providing guidance on conducting a hazard
assessment for OSHA general industry standards (29 CFR 1910 Subpart I
Appendix B), the employer should "exercise common sense and
appropriate expertise" in assessing hazards. By "appropriate
expertise," OSHA means that individuals conducting hazard assessments
must be familiar with the employer's work processes, materials, and
work environment. A thorough hazard assessment should include a walk-
through to identify sources of hazards to employees, wipe sampling to
detect beryllium contamination on surfaces, review of injury and
illness data, and employee input on the hazards to which
they are exposed. Information obtained in this manner provides a basis
for the identification and evaluation of potential hazards. OSHA
believes that the implementation of a comprehensive and thorough
program to determine areas of potential exposure, consistent with the
employer's written exposure control plan, is a sound safety and health
practice and a necessary element of ensuring overall worker protection.
Based on the hazard assessment results, the employer must determine
what PPE is necessary to protect employees from beryllium exposure. The
requirements for choosing PPE under OSHA's personal protective
equipment standards (e.g., 29 CFR 1910 Subpart I for general industry)
are performance-oriented, and are designed to allow the employer
flexibility in selecting the PPE most suitable for each particular
workplace. The type of PPE needed will depend on the potential for
exposure, the physical properties of the beryllium-containing material
used, and the conditions of use in the workplace. For example, shipping
and receiving activities may necessitate only work uniforms and gloves.
In other situations, such as when a worker is performing facility
maintenance, gloves, work uniforms, coveralls, and respiratory
protection may be appropriate. Beryllium compounds can exist in acidic
or alkaline form, and these characteristics may influence the choice of
PPE. Face shields may be appropriate in situations where there is a
danger of being splashed in the face with beryllium or a liquid
containing beryllium. Coveralls with a head covering may be appropriate
when a sudden release of airborne beryllium could result in beryllium
contamination of clothing, hair, or skin. Respirators are addressed
separately in the explanation of paragraph (g) earlier in this section
of the preamble.
Although some personal protective clothing may be worn over street
clothing, it is not appropriate for workers to wear protective clothing
over street clothing if doing so could reasonably result in
contamination of the workers' street clothes. In situations in which it
is not appropriate for workers to wear protective clothing over their
street clothes employers must select and ensure the use of protective
clothing that is worn in lieu of (rather than over) street clothing,
and must provide change rooms under paragraph (i)(2).
The Abrasive Blasting Manufacturers Alliance (ABMA) asserted that
the PPE requirements under this standard are not consistent with the
abrasive blasting requirements for construction and maritime (e.g., 29
CFR 1926.57(f), 29 CFR 1915.34) (Document ID 1673, pp. 22-23). OSHA
disagrees, based on the performance-oriented nature of the PPE
requirements in the final beryllium standards. If an employer provides
PPE that is appropriate and suitable for abrasive blasting and that
protects the employee's skin, this would be compliant with the
requirements under this final beryllium standard.
Paragraph (h)(2) contains requirements for removal and storage of
PPE. This provision is intended to reduce beryllium contamination in
the workplace and limit beryllium exposure outside the workplace.
Wearing contaminated clothing outside the beryllium work area could
lengthen the duration of exposure and carry beryllium from beryllium
work areas to other areas of the workplace. In addition, contamination
of personal clothing could result in beryllium being carried to
employees' cars and homes, increasing employees' exposure as well as
exposing others to beryllium hazards. An NJH collaborative study with
NIOSH documented inadvertent transfer of beryllium from the workplace
to workers' automobiles, and stressed the need for separating clean and
contaminated ("dirty") PPE (Document ID 0474, Sanderson, 1999). Toxic
metals brought by workers into the home via contaminated clothing and
vehicles continue to result in exposure to children and other household
members. A recent study of battery recycling workers found that lead
surface contamination above the Environmental Protection Agency level
of concern (>=40 μg/ft2) was common in the workers' homes and
vehicles (Document ID 1875, Centers for Disease Control and Prevention,
2012, pp. 967-970).
Under paragraph (h)(2)(i), beryllium-contaminated PPE must be taken
off at the end of the work shift, at the completion of tasks involving
beryllium exposure, or when PPE becomes visibly contaminated with
beryllium, whichever comes first. This provision is identical to the
corresponding paragraph in the proposed standard, except for a slight
reorganization to improve clarity and readability. Paragraph (h)(2)(i)
is intended to convey that PPE contaminated with beryllium should not
be worn when tasks involving beryllium exposure have been completed for
the day. For example, if employees perform work tasks involving
beryllium exposure for the first two hours of a work shift, and then
perform tasks that do not involve exposure, they should remove their
PPE after the exposure period to avoid the possibility of increasing
the duration of exposure and contamination of the work area from
beryllium residues on the PPE (i.e., re-entrainment of beryllium
particulate). If, however, employees are performing tasks involving
exposure intermittently throughout the day, or if employees are exposed
to other contaminants where PPE is needed, this provision requires the
employer to ensure that the employee wears is not intended to prevent
them from wearing the PPE until the completion of their shift, unless
it has become visibly contaminated with beryllium.
PPE that is visibly contaminated with beryllium should be changed
at the earliest reasonable opportunity. This provision is intended to
protect employees working with beryllium and their co-workers from
exposure due to accumulation of beryllium on PPE, and reduces the
likelihood of cross-contamination from beryllium-contaminated PPE.
Unlike the "visibly contaminated" language used in paragraph
(h)(1)(ii) of the proposal, which has been removed, OSHA has determined
that it is appropriate to use the same language here. Because the
purpose of PPE is to serve as a barrier between an employee's body and
ambient or surface beryllium, PPE becomes contaminated with beryllium
immediately as part of its protective function. Requiring PPE to be
changed upon contamination with any amount of beryllium is unreasonable
and unnecessary to protect employees. This is because contamination of
PPE with beryllium during work processes does not reduce the
effectiveness of PPE or create hazards to employees unless sufficient
beryllium accumulates on the PPE to impair its function or create
additional exposures, such as by dispersing accumulated beryllium into
the air. Furthermore, the process of changing contaminated PPE can
create opportunities for both inhalation exposure and dermal contact
with beryllium. The use of "visibly contaminated" protects employees
from potential exposures while changing PPE by limiting requirements to
change PPE during work tasks involving beryllium exposure to those
circumstances when changing it is necessary to maintain its protective
function and prevent deposits of beryllium from accumulating and
dispersing.
Using the "visible contamination" trigger in (h)(1)(ii) to
determine when employees must wear PPE in the first instance would have
reduced the protectiveness of the standard. Thus, OSHA determined that
it would be inappropriate to use such a trigger in that context.
However, as explained above, using "visibly contaminated" in
paragraph (h)(2)(i) actually increases the protectiveness of the
standard. It provides a cue for when it is unacceptable for a worker to
continue to work in his or her contaminated PPE, regardless of whether
a shift or a task involving beryllium exposure has been completed. This
common sense approach is supported by Materion in its post-hearing
comments: "If a job is such that company supplied work clothing may
become dirty, wear a personal protective over-garment to keep your work
clothing and your person clean. If your work clothing becomes dirty,
change it." (Document ID 1752).
Paragraph (h)(2)(ii) requires employees to remove PPE consistent
with the written exposure control plan required by paragraph (f)(1).
Paragraph (f)(1) specifies that the employer's written exposure control
plan must contain procedures for minimizing cross-contamination, and
procedures for the storage of beryllium-contaminated PPE, among other
provisions. While proposed paragraph (h)(2)(ii) only required personal
protective clothing to be removed pursuant to the written exposure
control plan, the final language includes personal protective equipment
as well as clothing. This change was made to ensure consistency with
the rest of paragraph (h) and to confirm OSHA's intent that beryllium-
contaminated personal protective equipment should be treated with the
same care as contaminated clothing in order to prevent additional
airborne exposure and dermal contact.
Paragraph (h)(2)(iii) requires employers to ensure that protective
clothing is kept separate from employees' street clothing and that
storage facilities prevent cross-contamination as specified in the
written exposure control plan. The language of this provision has been
modified slightly from the proposed standard to emphasize prevention of
cross-contamination as well as implementation of the written exposure
control plan, consistent with other requirements intended to limit
beryllium migration and cross-contamination. OSHA believes these
provisions are necessary to prevent the spread of beryllium throughout
and outside the workplace.
The remainder of paragraph (h)(2) is unchanged from the proposal
and did not elicit comments from stakeholders. To further limit
exposures outside the workplace, paragraph (h)(2)(iv) requires
employers to ensure that beryllium-contaminated PPE is only removed
from the workplace by employees who are authorized to do so for the
purpose of laundering, cleaning, maintaining, or disposing of such PPE.
These items must be brought to an appropriate location away from the
workplace. To be an appropriate location for purposes of paragraph
(h)(2)(iv), the facility must be equipped to handle beryllium-
contaminated items in accordance with these standards. The standards
further require in paragraph (h)(2)(v) that PPE removed from the
workplace for laundering, cleaning, maintenance, or disposal be placed
in closed, impermeable bags or containers. These requirements are
intended to minimize cross-contamination and migration of beryllium,
and to protect employees or other individuals who later handle
beryllium-contaminated items. Required warning labels should alert
those handling the contaminated PPE of the potential hazards of
exposure to beryllium. Such labels must conform with the hazard
communication standard (29 CFR 1910.1200) and paragraph (m)(3) of these
standards. These warning requirements are meant to reduce confusion and
ambiguity regarding critical hazard information communicated in the
workplace by requiring that this information be presented in a clear
and uniform manner.
Paragraph (h)(3) of the standards addresses the cleaning and
replacement of PPE. Proper cleaning is necessary to ensure that neither
the workers who use the PPE nor those who clean and maintain it are
exposed to beryllium via inhalation or dermal contact. Proper
replacement is necessary to ensure that the PPE continues to function
effectively in protecting workers from exposure. Paragraph (h)(3) is
unchanged from the proposal.
Paragraph (h)(3)(i) requires the employer to ensure that reusable
PPE is cleaned, laundered, repaired, and replaced as needed to maintain
its effectiveness. In keeping with the performance orientation of the
standards, OSHA does not specify how often PPE should be cleaned,
repaired, or replaced. Appropriate time intervals for these actions may
vary widely based on the types of PPE used, the nature of the beryllium
exposures, and other circumstances in the workplace. However, even in
the absence of a mandated schedule, these requirements must be
completed at a frequency, and in a manner, sufficient to ensure that
PPE continues to serve its intended purpose of protecting workers from
beryllium exposure.
Several commenters discussed the merits of the use of disposable
PPE versus reusable PPE. These commenters indicated that OSHA should
allow the use of disposable PPE, which could be both more protective
and, in some cases, less costly, than reusable PPE (Document ID 1676,
p. 3; 1682, p. 3). In response, OSHA notes that it is not prohibiting
the use of disposable PPE. As discussed above, OSHA is leaving the
decision regarding appropriate PPE to employers after they do their
hazard assessments. While these commenters indicated that the
regulatory text seems to focus on reusable PPE, the requirements
specifically regarding reusable PPE are necessary to ensure that
workers who handle this PPE downstream (for example, workers who
launder or repair PPE) are protected and that reusable PPE is
appropriately handled and cleaned before being reused. These provisions
are not meant to indicate that OSHA prefers reusable PPE over
disposable PPE.
Under paragraph (h)(3)(ii), removal of beryllium from PPE by
blowing, shaking, or any other means which disperses beryllium in the
air is prohibited as this practice could result in unnecessary and
harmful exposure to airborne beryllium. Paragraph (h)(3)(iii) requires
the employer to inform, in writing, any person or business entity who
launders, cleans, or repairs PPE required by this standard of the
potentially harmful effects of exposure to airborne beryllium and
dermal contact with beryllium, and of the need to handle the PPE in
accordance with this standard. This provision is intended to limit
dermal and inhalation exposure to beryllium, and to emphasize the need
for hazard awareness and protective measures consistent with these
standards among persons who clean, launder, or repair beryllium-
contaminated items.
(i) Hygiene Areas and Practices
Paragraph (i) of the final standards for general industry,
construction, and shipyards requires that, when certain conditions are
met, the employer must provide employees with readily accessible
washing facilities and change rooms. Additionally, paragraph (i) of the
final standard for general industry requires that, when certain
conditions are met, the employer must provide showers for employee use.
Paragraph (i) of all three standards also requires the employer to take
certain steps to minimize exposure in eating and drinking areas, and
prohibits certain practices that may contribute to beryllium exposure.
The final standards' hygiene provisions are consistent with other OSHA
standards providing similar protection. For example, OSHA health
standards for hexavalent chromium (29 CFR 1910.1026) and lead (29 CFR
1910.1025) include hygiene provisions along with engineering control
requirements to protect workers from exposure to toxic substances.
OSHA's standards addressing sanitation in general industry (29 CFR
1910.141), construction (29 CFR 1926.51) and shipyard employment (29
CFR 1915.88) also include hygiene provisions, requiring the employer to
provide change rooms equipped with storage facilities for street
clothes and separate storage facilities for protective clothing
whenever employees are required by an OSHA standard to wear protective
clothing because of the possibility of contamination with toxic
materials. The sanitation standards also include provisions for washing
facilities and prohibit storage or consumption of food or beverages in
any area exposed to a toxic material.
OSHA requested comment on the hygiene provisions of the proposed
standard for general industry, which was similar in most respects to
the hygiene provisions of the final general industry standard. It
required employers to provide readily accessible washing facilities,
change rooms and showers and to ensure the use of these facilities for
each employee exposed to beryllium when necessary. The proposed
standard also required employers to take certain steps to minimize
exposure in eating and drinking areas and prohibited certain practices
that may contribute to beryllium exposure. The remainder of this
section discusses general comments on the hygiene section; explains the
hygiene provisions of the final standards and OSHA's response to
comments on each provision; and discusses differences between the
proposed and final standards and differences between the final
standards for each sector.
Most commenters agreed with the need for hygiene areas and
practices to protect workers from airborne exposure to and dermal
contact with beryllium (Document ID 1664, p. 7; 1665, pp. 10-11; 1667,
pp. 5-6; 1675, p. 13; 1679, p. 9; 1680, p, 5; 1689, p. 12). However,
one commenter stated that its engineering control systems eliminated
the need for hygiene facilities (Document ID 1615, p. 8). OSHA
disagrees that engineering controls alone are sufficient to eliminate
the need for hygiene areas and practices. Because significant risk of
beryllium sensitization and CBD remain below the TWA PEL in the final
beryllium standards, ancillary provisions such as requirements for
hygiene areas and practices are appropriate to further reduce that
risk. See Building and Constr. Trades Dept. v. Brock (Asbestos II), 838
F.2d 1258, 1274 (D.C. Cir. 1988). As discussed in this preamble at
Section V, Health Effects and Section VI, Risk Assessment, dermal
contact with beryllium can cause beryllium sensitization, the first
step in the development of CBD. Compliance with the hygiene provisions
of the final standards will reduce the amount and duration of
employees' dermal contact with beryllium, and will therefore more
effectively reduce employees' risk of developing CBD than would
compliance with the TWA PEL alone.
Another commenter noted that hygiene areas and practices specified
in the proposal exceed requirements for abrasive blasting operations
discussed in OSHA's Ventilation standard for construction (29 CFR
1926.57) and Mechanical paint removers standard in maritime employment
(29 CFR 1915.34) (Document ID 1673, p. 23). Ancillary provisions in
standards for specific substances such as beryllium complement these
general OSHA standards. As OSHA noted in Section XVIII of the NPRM, the
standards for abrasive blasting provide protection primarily to
blasting operators, and do not apply to other employees who are likely
to experience beryllium exposures, such as blasting helpers and cleanup
workers. In addition, OSHA expects the hygiene provisions in the final
beryllium standards to decrease the airborne exposure and dermal
contact even of employees who wear respiratory protection and PPE
required by other standards, and will therefore reduce significant risk
of beryllium-related health effects among abrasive blasters in
construction and shipyards.
Paragraph (i)(1) of the proposed standard required that employers
provide, for each employee working in a beryllium work area, readily
accessible washing facilities to remove beryllium from the hands, face,
and neck. It also required employers to ensure that each employee
exposed to beryllium use these facilities when necessary.
The requirements for washing facilities will reduce employees' skin
contact with beryllium, the possibility of accidental ingestion and
inhalation of beryllium, and the spread of beryllium within and outside
the workplace. As discussed in Section V of this preamble, Health
Effects, respiratory tract, skin, eye, or mucosal contact with
beryllium can result in beryllium sensitization, which is a necessary
first step toward the development of CBD. Also, beryllium can
contaminate employees' clothing, shoes, skin, and hair, prolonging
workers' beryllium exposure and exposing others such as family members
if proper hygiene practices are not observed. A study by Sanderson et
al. measured the levels of beryllium on workers' skin and vehicle
surfaces at a machining plant. The study showed beryllium was present
on workers' skin and in their vehicles, demonstrating that workers
carried residual beryllium on their hands when leaving work (Sanderson
et al., 1999, Document ID 0474). In addition, dermal contact with
beryllium has been shown to occur even at low airborne exposure levels.
For example, skin wipe sample analysis of dental laboratory technicians
performing grinding operations demonstrated that beryllium was present
on the hands of workers even when airborne exposures were well below
the TWA PEL (Document ID 1878, pp. 8-9).
The requirements in the standards to use washing facilities are
performance-oriented, simply requiring employees to use the washing
facilities to remove beryllium from their skin when the criteria in
paragraph (i)(1) of the standards are met. Typically, washing
facilities will consist of one or more sinks, soap or another cleaning
agent, and a means for employees to dry themselves after washing. OSHA
does not intend to require the use of any particular soap, cleaning
agent, or drying mechanism. Employers can provide whatever washing
materials and equipment they choose, as long as those materials and
equipment are effective in removing beryllium from the skin and do not
themselves cause skin or eye problems.
Washing reduces exposure by limiting the period of time that
beryllium is in contact with the skin, and helps prevent accidental
ingestion. Although engineering and work practice controls and
protective clothing and equipment are designed to prevent hazardous
skin and eye contact, OSHA realizes that in some circumstances exposure
will nevertheless occur. For example, an employee who wears gloves to
protect against hand contact with beryllium may inadvertently touch his
or her face with the contaminated glove during the course of the day.
The purpose of requiring washing facilities is to mitigate adverse
health effects when skin or eye contact with beryllium occurs.
OSHA did not receive comment on this provision. Therefore,
paragraph (i)(1) of the final standards is substantively unchanged from
proposed paragraph (i)(1). Paragraph (i)(1) of the final standard for
general industry requires the employer to provide readily accessible
washing facilities for employees who work in beryllium work areas to
remove beryllium from the
hands, face, and neck and ensure that employees who have had dermal
contact with beryllium use these facilities at the end of the activity,
process, or work shift and prior to eating, drinking, smoking, chewing
tobacco or gum, applying cosmetics, or using the toilet.
Because the standards for construction and shipyards do not require
beryllium work areas, the requirements for washing facilities set forth
in paragraph (i)(1) of the construction and shipyard standards differ
from the general industry standard in that they require employers to
provide washing facilities for each employee required to wear personal
protective clothing or equipment by the final standards--that is, where
employees are reasonably expected to be exposed to beryllium above the
TWA PEL or STEL or where there is a reasonable expectation of dermal
contact with beryllium. Otherwise, the requirements for washing
facilities are the same in all three standards.
Paragraph (i)(2) of the proposed standard required employers to
provide affected employees with a designated change room and washing
facilities in accordance with the proposed standard and the Sanitation
standard where employees were required to remove their personal
clothing.
Change rooms allow employees to remove their personal clothing in
order to use personal protective clothing. Minimizing contamination of
employees' personal clothes will also reduce the likelihood that
beryllium will contaminate employees' cars and homes, and other areas
outside the workplace. Requiring employers to provide employees with
change rooms to change out of work clothes, which are then segregated
from their street clothes, and to leave work clothing at the workplace
significantly reduces the possibility of beryllium migration outside
the workplace, providing added protection from take-home beryllium
exposure to workers and their families.
One commenter recommended that change rooms be required only when
there is required use of personal protective clothing and equipment
(Document ID 1667, pp. 5-6). OSHA intends the change rooms requirement
only to apply to covered workplaces where employees must change their
clothing (i.e., take off their street clothes) to use protective
clothing. In situations where removal of street clothes is not
necessary (e.g., in a workplace where only gloves are used as
protective clothing), change rooms are not required. The standards do
not create a requirement for employees to change their clothing. Note
that paragraph (h) of all three standards requires employers to provide
"appropriate" personal protective clothing. It is not appropriate for
employees to wear protective clothing over street clothing if doing so
results in contamination of the employee's street clothes. In such
situations, the employer must ensure that employees wear protective
clothing in lieu of (rather than over) street clothing, and provide
change rooms.
Another commenter stated that the final rule should require
employers to develop a program that defines approved storage areas for
protective apparel and personal hygiene towels, restricts access to
this area, provides for employee training when handling or reusing
previously used items, and establishes an objective means for
determining when an item can no longer be reused and must be laundered
or discarded (Document ID 1962, p. 5). OSHA agrees that employers
should develop and document procedures for limiting beryllium cross-
contamination and migration, and has included such requirements in
paragraph (f), Methods of Compliance, and paragraph (j), Housekeeping.
These paragraphs of the final standards require each employer to
develop, document, and implement procedures for limiting beryllium
migration and cross-contamination in their facilities, which should
address storage, handling and reuse of beryllium-contaminated items and
access to storage facilities for beryllium-contaminated clothing and
PPE, including towels if these are contaminated with beryllium during
washing and showering.
After carefully reviewing the record, OSHA has decided to keep
paragraph (i)(2) substantively unchanged. Paragraph (i)(2) of the final
standard for general industry requires the employer to provide a
designated change room for employees who work in a beryllium work area
and are required to remove their personal clothing. Paragraph (i)(2) of
the final standards for construction and shipyards requires the
employer to provide a designated change room for employees who are
required by the final standards to wear personal protective clothing or
equipment and are required to remove their personal clothing. The
changed trigger for change rooms in the construction and shipyard
standards is due to the fact that there are no beryllium work areas in
those standards, and requiring change rooms where employees are
required to wear personal protective clothing or equipment provides a
similar level of protection to the general industry standard. Change
rooms must be designed in accordance with the written exposure control
plan required by paragraph (f)(1) of all three standards, and with the
applicable Sanitation standards in general industry (29 CFR 1910.141),
construction (29 CFR 1926.51), and shipyards (29 CFR 1915.88). These
Sanitation standards require change rooms to be equipped with storage
facilities (e.g., lockers) for protective clothing, and separate
storage facilities for street clothes, to prevent cross-contamination.
As in the proposed standard for general industry, paragraph (i)(3)
of the final standard for general industry requires employers in
general industry to provide and ensure the use of showers if employees
are or can reasonably be expected to be exposed above the TWA PEL or
STEL (paragraph (i)(3)(i)(A)) and if employees' hair or body parts
other than hands, face, and neck could reasonably be expected to be
contaminated with beryllium (paragraph (i)(3)(i)(B)). Employers are
only required to provide showers if paragraphs (i)(3)(i)(A) and (B)
both apply. Paragraph (i)(3)(ii) of the final standard for general
industry, like the proposed standard for general industry, requires
employers to ensure that employees use the showers at the end of the
work activity or shift involving beryllium if the employees reasonably
could have been exposed above the TWA PEL or STEL, and if beryllium
could reasonably have contaminated the employees' body parts other than
hands, face, and neck. The requirement is restricted to body parts
other than the hands, face, and neck because if employees have dermal
contact with beryllium on their hands, faces, or necks, they must use
the washing facilities required by paragraph (i)(1)(i). This language
is intended to convey that showers must be used immediately after work
activities involving beryllium exposure have been completed for the
day. For example, if employees perform work activities involving
beryllium exposure that meet the requirements for showers for the first
two hours of a work shift, and then perform activities that do not
involve exposure, they should shower after the exposure period to avoid
increasing the duration of exposure, potential of accidental ingestion,
and contamination of the work area from beryllium residue on their hair
and body parts other than hands, face, and neck. If, however, employees
are performing tasks involving exposure intermittently throughout the
day, this provision is intended to require them to shower after the
last task involving exposure, not after the completion of each such
task.
The requirements of paragraph (i)(3) of the final standard for
general industry are similar to requirements for provision and use of
shower facilities in other substance-specific OSHA health standards,
such as the standards for cadmium (29 CFR 1910.1027) and lead (29 CFR
1910.1025), which also require showers when exposures exceed the TWA
PEL. OSHA's standard for coke oven emissions (29 CFR 1910.1029)
requires employers to provide showers and ensure that employees working
in a regulated area shower at the end of the work shift. The standard
for methylenedianiline (MDA) (29 CFR 1910.1050) requires employers to
ensure that employees who may potentially be exposed to MDA above the
action level shower at the end of the work shift.
A majority of the comments on the proposed hygiene areas and
practices provisions for general industry concerned the requirement for
showers. The Sampling and Analysis Subcommittee Task Group of the
Beryllium Health and Safety Committee (BHSC Task Group) expressed
support for the mandatory use of showers for workers in beryllium
regulated areas where airborne exposures can reasonably be expected to
exceed the TWA PEL or STEL so that proper decontamination can occur and
prevent beryllium from leaving the work area, and to ensure that
workers and their families are not exposed to beryllium once workers
leave their place of employment (Document ID 1665, pp. 10-11). Ameren
Corporation (Ameren), the United Steelworkers (USW), and Materion
Corporation (Materion) also supported the requirement for showers and
their use by employees working in a beryllium regulated area (that is,
where airborne exposures can reasonably be expected to exceed the TWA
PEL or STEL) (Document ID 1675, p. 13; 1680, p. 5; 1681, p.12).
Some commenters supported the requirement for showers, but
suggested that employers should be required to provide shower
facilities to workers exposed at lower exposure levels than the TWA PEL
or STEL. National Jewish Health (NJH) suggested that showers should be
required for workers exposed above the action level rather than the TWA
PEL or STEL and in facilities where beryllium can be expected to
contaminate the employees' hair or other body parts (Document ID 1664,
p. 7). The North America's Building Trades Unions (NABTU) suggested
that any beryllium work area should include all necessary
decontamination facilities, including showers (Document ID 1679, p. 9).
OSHA notes that NJH and NABTU's comments addressed the provisions
of the proposed standard for general industry, which did not include a
requirement to provide PPE wherever there is a potential for dermal
contact with beryllium. As discussed previously in the Summary and
Explanation for paragraph (h) of the final standards, OSHA has adopted
much more comprehensive requirements for employers to provide and
ensure the use of personal protective clothing and equipment (PPE)
wherever exposure exceeds the TWA PEL or STEL or dermal contact with
beryllium is reasonably expected to occur. The Agency believes that
employees working in low-exposure contexts (where exposures do not
exceed the TWA PEL or STEL) and using comprehensive PPE as required in
paragraph (h) are unlikely to experience beryllium contamination that
requires shower facilities to effectively remove beryllium from the
hair and skin. OSHA therefore concludes that the required washing
facilities and change rooms for general industry employees working in
beryllium work areas in combination with the comprehensive PPE
requirements described in paragraph (h) of the final standards are
sufficient to protect workers in areas where exposures do not exceed
the TWA PEL or STEL and where there is no reasonable expectation that
body areas other than hands, face and neck will be contaminated with
beryllium. OSHA therefore has decided not to require the provision of
showers in general industry workplaces where exposure does not exceed
the TWA PEL or STEL.
The Boeing Company (Boeing) suggested requiring showers only when
beryllium visibly contaminates employees' hair or body parts other than
hands, face, and neck (Document ID 1667, p. 6). However, as discussed
previously in the Summary and Explanation of paragraph (h), Personal
Protective Clothing and Equipment, dermal contact with beryllium can
lead to adverse health effects regardless of whether sufficient
beryllium-containing dust has accumulated to be visible to the naked
eye. Therefore, OSHA has determined that requiring showers only where
beryllium contamination is visible would not adequately protect
employees from prolonged dermal contact with beryllium or adequately
prevent transfer of beryllium outside the workplace.
Another commenter suggested that air showers for when employees
leave the work area would be more cost effective and acceptable than
water-based showers (Document ID 1596, p. 1). OSHA does not believe
that air showers are appropriate for removing beryllium from workers'
skin. Air showers are designed to remove accumulations of dust from the
surface of work clothing, PPE, and exposed skin, but cannot remove
residual beryllium as effectively as washing with water and soap. In
addition, air showers can disperse beryllium-containing dust into the
air and cause employees additional airborne exposure, whereas water-
based showers do not re-entrain dust into the air.
OSHA has not included a requirement for showers in the final
standards for construction and shipyards. Workers in these industries
are exposed to beryllium primarily when an abrasive that contains trace
amounts of beryllium, usually coal or copper slags, is used during
abrasive blasting operations. These abrasive slags contain less than
0.1% beryllium but may result in significant airborne exposure to
beryllium because of the high dust levels generated during abrasive
blasting. However, workers conducting abrasive blasting with these
abrasives are currently protected from dermal contact with beryllium
under existing OSHA standards. The OSHA Ventilation standard for
construction (29 CFR 1926.57) and the OSHA Mechanical paint removers
standard for shipyard employment (29 CFR 1915.34) require personal
protective clothing and respiratory protection for abrasive blasters.
The Ventilation standard requires employers to use only respirators
approved by NIOSH under 42 CFR part 84 for protecting employees from
dusts produced during abrasive-blasting operations (29 CFR
1926.57(f)(5)(i)) and abrasive-blasting respirators must be worn by all
abrasive-blasting operators (29 CFR 1926.57(f)(5)(ii)). These abrasive
blasting respirators cover the entire head, neck and shoulder area to
protect the worker from rebounding abrasive during these operations and
prevent beryllium exposure to the head and neck area. The Mechanical
paint removers standard has similar requirements for abrasive blasters
including the use of hoods and airline respirators, along with
protective clothing (29 CFR 1915.34(c)). Compliance with these
requirements should effectively prevent contamination of abrasive
blasters' bodies with beryllium; thus, use of showers to remove
beryllium is unnecessary for these workers.
Abrasive blasting support workers such as pot tenders and cleanup
workers are also potentially exposed to beryllium during abrasive
blasting
activities (Chapter IV, Technological Feasibility). However, their work
is usually remote from the actual abrasive blasting or occurs prior to
or after the operation is completed, resulting in lower exposures.
OSHA's exposure profile for these workers shows a median exposure below
the final standards' action level (0.09 μg/m3\ for pot tenders and
helpers and 0.07 μg/m3\ for cleanup helpers) which is well below
the median exposure level of 0.2 μg/m3\ for abrasive blasters
(Chapter IV, Technological Feasibility) and well below the trigger for
provision of showers established in the final standard for general
industry. While abrasive blasting support workers are not exposed to
the high dust levels experienced by the abrasive blasting operator,
these workers are nevertheless protected under the personal protective
clothing and equipment requirements in paragraph (h) of the final
standards which requires the use of appropriate personal protective
clothing and equipment where exposure can reasonably be expected to
exceed the TWA PEL or STEL or where there is a reasonable expectation
of dermal contact with beryllium. Based on the personal protective
clothing and equipment requirements under OSHA standards for abrasive
blasting operators and support workers, and the low exposure levels
described above and in Chapter IV, Technological Feasibility, OSHA is
not requiring showers in the final standards for construction and
shipyards. OSHA also notes that providing showers can be impractical in
some temporary worksites, such as those often used in construction
settings.
Paragraph (i)(4) (eating and drinking areas) of OSHA's proposed
rule for general industry required that whenever the employer allows
employees to consume food or beverages at a worksite where beryllium is
present, the employer must ensure that surfaces in eating and drinking
areas are as free as practicable of beryllium to minimize the
possibility of food contamination and the likelihood of additional
exposure to beryllium through inhalation or ingestion. Proposed
paragraph (i)(4) further required employers to ensure that no employee
in eating and drinking areas is exposed to airborne beryllium at or
above the action level, and that eating and drinking areas must comply
with the Sanitation standard (29 CFR 1910.141). Paragraph (i)(5)(ii)
(prohibited activities) of the proposed rule, also related to eating
and drinking areas, required the employer to ensure that no employees
enter any eating or drinking area with personal protective clothing or
equipment unless, prior to entry, surface beryllium has been removed
from the clothing or equipment by methods that do not disperse
beryllium into the air or onto an employee's body.
A commenter with the American Federation of Labor and Congress of
Industrial Organizations (AFL-CIO) recommended that OSHA develop
stronger language to ensure that exposure levels are "well below" the
action level for eating and drinking areas and that surfaces are truly
as free as practicable of beryllium (Document ID 1689, pp. 12-13). OSHA
agrees with the commenter that airborne beryllium should be maintained
well below the action level in eating and drinking areas and has
decided not to include the proposal's hygiene provision that no
employee in eating and drinking areas is exposed to airborne beryllium
at or above the action level in the final standards. OSHA believes that
this language may be interpreted to allow airborne exposure levels up
to the action level in eating and drinking areas, which is not OSHA's
intent. The requirements to maintain surfaces in these eating and
drinking areas as free as practicable of beryllium and to ensure that
employees do not enter eating and drinking areas with personal
protective work clothing or equipment unless beryllium has been removed
will limit contamination and airborne exposure to beryllium and provide
workers with safe areas to eat and drink.
In comments on surface cleanliness pertaining to eating and
drinking areas, Boeing suggested that the standard should define
specific surface contaminant levels or instead simply rely on the
existing OSHA Sanitation standard (1910.141) (Document ID 1667, p. 6).
Kimberly-Clark Professional (KCP) suggested that OSHA should set a
future goal of establishing maximum allowable surface contamination
standards for toxic substances (Document ID 1962, p. 3). Materion
suggests that its "visibly clean" standard is analogous to OSHA's
standard of "as free as practicable" and that its cleaning program
ensures that surfaces remain "as free as practicable" of beryllium
(Document ID 1807, p. 5). Materion and USW proposed the term "visibly
clean" because they "have found it to be well understood by both
workers and management" (Document ID 1808, p. 4). However, Materion
also points out that the use of the term "as free as practicable" has
been understood by workers, management and OSHA compliance officers and
has been successfully applied and effective in practice: "[f]or
decades, OSHA has used the term "as free as practicable" in its
substance specific standards . . . OSHA's use of this term has been
understood by workers, management and OSHA compliance officers. OSHA
has successfully applied this compliance term in many prior OSHA
standards which serves to demonstrate that its use is understandable
and effective in practice" (Document ID 1808, p. 5). In post-hearing
comments, KCP states its belief that "visibly contaminated" is an
inadequate standard and should not be used as a stand-in for "as clean
as practicable" (Document ID 1962, p. 2).
In developing the final standards, OSHA carefully considered these
comments on the use of "as free as practicable" and alternative
requirements in reference to surface cleanliness in eating and drinking
areas and elsewhere in the beryllium standards, and concluded that "as
free as practicable" is the most appropriate terminology for
requirements pertaining to surface cleanliness. Issues related to use
of "as free as practicable" and alternatives to this language are
also discussed in the Summary and Explanation for paragraph (j),
Housekeeping.
The requirement to maintain surfaces as free as practicable of the
regulated substance is included in other OSHA health standards such as
those for lead in general industry (29 CFR 1910.1025), lead in
construction (29 CFR 1926.62), chromium (IV) (29 CFR 1910.1026), and
asbestos (29 CFR 1910.1001). Employers therefore have the benefit of
previous experience interpreting and developing methods for compliance
with requirements to maintain surfaces "as free as practicable" of
toxic substances, as well as guidance from OSHA on compliance with such
requirements. As OSHA explained in a January 13, 2003 letter of
interpretation concerning the meaning of "as free as practicable" in
OSHA's Lead in Construction standard, OSHA evaluates whether a surface
is "as free as practicable" of a contaminant by the rigor of the
employer's program to keep surfaces clean (OSHA, 2003, Document ID
0550). A sufficient housekeeping program may be indicated by a routine
cleaning schedule and the use of effective cleaning methods to minimize
the possibility of exposure from accumulation of beryllium on surfaces.
OSHA's compliance directive on Inspection Procedures for the Chromium
(VI) Standards provides additional detail on how OSHA interprets "as
free as practicable" for enforcement purposes (OSHA, 2008, Document ID
0546, pp. 45-47). As explained in the directive, if a wipe
sample reveals a toxic substance on a surface, and the employer has not
taken practicable measures to keep the surface clean, the employer has
not kept the surface as free as practicable of the toxic substance.
Thus, OSHA believes that the term "as free as practicable" is clearly
understood by employers through its use in other standards and as
explained in letters of interpretation and is using this term in the
hygiene provision of the final standards.
OSHA does not set quantitative limits for surface contamination
because the best available scientific evidence on adverse health
effects from dermal contact with beryllium does not provide sufficient
information to link risk of adverse health effects with specific levels
of surface contamination. As described above, OSHA finds that wipe
sampling can be helpful in determining whether an employer is in
compliance with a requirement to keep surfaces as free as practicable
of toxic substances, but concludes that use of a specific target level
of surface contamination should not define compliance with surface
cleanliness requirements of the beryllium standards.
Based on these conclusions, paragraph (i)(4) of the final standards
requires that wherever the employer allows employees to consume food or
beverages at a worksite where beryllium is present, the employer must
ensure that surfaces in these areas are as free as practicable of
beryllium. The employer must also ensure that employees do not enter
eating and drinking areas with personal protective work clothing or
equipment unless, prior to entry, surface beryllium has been removed
from the clothing and equipment by methods that do not disperse
beryllium into the air or onto an employee's body, further protecting
workers from beryllium contamination in areas where eating and drinking
occurs. Eating and drinking areas must further comply with the
Sanitation standards (29 CFR 1910.141(g), 1926.51(g), 1915.88(h)),
which prohibit consuming or storing food or beverages in a toilet area
or in any area exposed to a toxic material. In the final standards, the
provisions for eating and drinking areas (paragraph (i)(4) of the
general industry standard, paragraph (i)(3) of the construction and
shipyard standards) and prohibited activities (paragraph (i)(5) of the
general industry standard and paragraph (i)(4) of the construction and
shipyard standards) have been retained with one exception and one
structural change. The proposed requirement to ensure that no employee
in eating and drinking areas is exposed to airborne beryllium at or
above the action level has been removed for the reasons already
discussed above. And the requirement concerning employees entering any
eating or drinking area with personal protective clothing or equipment
has been moved from the prohibited activities section of the proposed
rule's hygiene provision to the eating and drinking areas section in
the final standards.
Paragraph (i)(4) of the final standard for general industry and
paragraph (i)(3) of the final standards for construction and shipyards
do not require the employer to provide separate eating and drinking
areas to employees at the worksite. Employees may consume food or
beverages offsite. However, where the employer chooses to allow
employees to consume food or beverages at a worksite where beryllium is
present, the employer is required to maintain the area in accordance
with paragraph (i)(4) of the final standard for general industry or
paragraph (i)(3) of the final standards for construction and shipyards,
and with the applicable Sanitation standard (29 CFR 1910.141, 29 CFR
1915.1915.88, or 29 CFR 1926.51), and the employer must ensure that
employees do not enter eating and drinking areas wearing contaminated
personal protective clothing or equipment.
Paragraph (i)(5)(i) of the proposed standard, setting forth
prohibited activities, required the employer to ensure that no
employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in
regulated areas. OSHA did not receive comment on this provision.
Therefore, paragraph (i)(5) of the final standards is substantively
unchanged from proposed paragraph (i)(5)(i). Paragraph (i)(4) of the
final construction and shipyard standards is substantively identical to
paragraph (i)(5) of the general industry standard.
Paragraph (i)(5) of the final standard for general industry and
paragraph (i)(4) of the final standard for shipyards prohibit eating,
drinking, smoking, chewing tobacco or gum, or applying cosmetics in
regulated areas (areas where airborne exposure to beryllium is expected
to exceed the TWA PEL or STEL). Paragraph (i)(4) of the final standard
for construction differs slightly in that the employer is required to
ensure that no employees eat, drink, smoke, chew tobacco or gum, or
apply cosmetics in work areas where there is a reasonable expectation
of exposure above the TWA PEL or STEL. This difference arises because
the final standard for construction does not have a requirement for
regulated areas but instead relies on a competent person provision
(paragraph (e)) to restrict employee access to areas where exposures
are, or can reasonably be expected to be, above the TWA PEL or STEL.
Exposure at these levels creates a greater risk of beryllium
contaminating the food, drink, tobacco, gum, or cosmetics. Prohibiting
eating and drinking in these areas will reduce the potential for this
manner of exposure.
For the foregoing reasons, OSHA has decided to promulgate all the
requirements of the proposed hygiene areas and practices provisions in
the beryllium final standard for general industry except for the eating
and drinking areas action level limit noted above. For the final
standards for construction and shipyards, OSHA has decided to include
all of the hygiene areas and practices provisions proposed for general
industry except for the requirement for showers and the eating and
drinking areas action level limit.
(j) Housekeeping
Paragraph (j) of the final standard for general industry requires
employers to maintain all surfaces in beryllium work areas as free as
practicable of beryllium; promptly clean spills and emergency releases
of beryllium; use appropriate cleaning methods; and properly dispose of
materials containing or contaminated with beryllium. Paragraph (j) of
the final standards for construction and shipyards requires employers
to follow the written exposure control plan required under paragraph
(f)(1) when cleaning beryllium-contaminated areas, use appropriate
cleaning methods, and provide recipients of beryllium-containing
materials for use or disposal with a copy of the warning described in
paragraphs (m)(2) and (m)(3), respectively.
As discussed in more detail below, the housekeeping requirements in
the final standards are similar to those included in the proposal.
While some stakeholders submitted divergent opinions on certain aspects
of the proposed provisions, several commenters offered broad support
for the inclusion of housekeeping provisions in the final rule (e.g.,
Document ID 1664, p. 7; 1681, Attachment 1, p. 13). For example, United
Steelworkers (USW) stated that "the proposed text provides employers
with clear responsibilities and provides strong provisions to ensure
worker protection" (Document ID 1681, Attachment 1, p. 13). USW also
expressed appreciation for the "precautions incorporated into this
section to minimize the amount of particulate suspended in the air"
(Document ID 1681, Attachment 1, p. 13). Another stakeholder, National
Jewish Health (NJH), agreed with the
proposed rule regarding housekeeping (Document ID 1664, p. 7).
Similarly, the American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO) argued that "housekeeping provisions are
essential" "[b]ecause of the hazardous nature of beryllium and the
significant risk of developing beryllium sensitization or disease"
(Document ID 1689, p. 13).
These comments support OSHA's view, as expressed in the NPRM, that
these provisions are important because they minimize additional sources
of exposure to beryllium that engineering controls do not completely
eliminate. Good housekeeping measures are a cost-effective way to
control worker exposures by removing settled beryllium that could
otherwise become re-entrained into the surrounding atmosphere by
physical disturbances or air currents and could enter an employee's
breathing zone. Moreover, housekeeping provisions may be especially
critical in the final beryllium standards because contact with
contaminated surfaces can result in dermal exposure to beryllium. As
discussed in this preamble at section V, Health Effects, researchers
have identified skin exposure to beryllium as a pathway to
sensitization. In addition, the housekeeping provisions in paragraph
(j) of the standards for general industry, construction, and shipyards
are generally consistent with housekeeping requirements in other OSHA
standards for toxic metals, including cadmium (29 CFR 1910.1027,
1926.1127), chromium (VI) (29 CFR 1910.1026), and lead (29 CFR
1910.1025, 1926.62).
The Abrasive Blasting Manufacturers Alliance (ABMA) asserted that
the proposed housekeeping requirements are not consistent with the
abrasive blasting requirements for construction and shipyards (e.g., 29
CFR 1926.57(f), 29 CFR 1915.34) (Document ID 1673, pp. 22-23). OSHA
disagrees. The performance-oriented provisions in the final
construction and shipyard standards for beryllium provide employers
with a great deal of flexibility in cleaning beryllium-contaminated
areas and spills and emergency releases of beryllium and disposing of
materials designated for disposal or recycling. In essence, the text
requires employers to choose cleaning methods that minimize the
likelihood and level of airborne exposure (unless certain conditions
are met), handle and maintain cleaning equipment in a way that
minimizes exposure, and protect their employees when dry sweeping,
brushing, or using compressed air to clean in beryllium-contaminated
areas. When transferring materials containing beryllium to another
party for use or disposal, the employer is required to advise the
recipient of the beryllium content and hazards. These provisions
complement, rather than contradict, the rules set out in 29 CFR
1926.57(f) and 29 CFR 1915.34, and are necessary for employee
protection from beryllium-related adverse health effects.
Paragraph (j)(1)(i) of the proposed rule would have required
employers to maintain all surfaces in beryllium work areas as free as
practicable of accumulations of beryllium and in accordance with the
exposure control plan required under paragraph (f)(1) and the cleaning
methods required under paragraph (j)(2) of the proposed rule. In this
context, the phrase "as free as practicable" set forth the baseline
goal in the development of an employer's housekeeping program to keep
work areas free from surface contamination. For a detailed discussion
of the meaning of the phrase "as free as practicable," see the
discussion in the Summary and Explanation for paragraph (i), Hygiene
areas and practices, in this section of the preamble.
Although this requirement is often included in OSHA's substance
specific regulations, a number of commenters expressed concern about
its inclusion in this rulemaking. For example, USW argued that a
"requirement to maintain all surfaces in beryllium work areas as free
as practicable of accumulations of beryllium could lead to difficulties
in assessing compliance, since `as free as practicable' is open to
interpretation"; instead, USW suggested that beryllium work areas
should be required to be maintained "visibly clean" of accumulations
(Document ID 1681, p. 13). Materion Corporation (Materion) also
proposed the term "visibly clean" (Document ID 1808, p. 5; 1752, p.
1). However, Materion stated that OSHA has long used the term "as free
as practicable" in its standards as a measure of cleanliness for work
areas and eating areas, and the term is well understood by workers,
management, and OSHA compliance officers. According to Materion,
"visibly clean" is similar to "as free as practicable" and also
well understood by workers and management (Document ID 1808, p. 5).
Kimberly-Clark Professional (KCP) stated that this "ostensible
equivalence" between the "as free as practicable" and "visibly
clean" standards is "unfounded," in part, because "[i]t is
practicable using readily known and available methods to make many
surfaces clean beyond that which is visibly apparent" (Document ID
1962, p. 2). Instead, KCP recommended that OSHA "establish surface
contamination standards such that all subjectivity of surface
cleanliness is removed" (Document ID 1962, p. 2). KCP also argued that
OSHA should require an employer's surface cleanliness protocol to be
based on objective sampling and measurement. KCP maintained that there
are many examples where surface sampling is used in economically
feasible ways, including in the facilities governed by the Department
of Energy (DOE). However, it acknowledged that the methods in other
environments, including the DOE protocols for beryllium control in
energy facilities, may not translate directly to industrial facilities.
Nevertheless, KCP observed that "there is sufficient ongoing
successful use of such approaches to provide a framework for a more
objective, data-driven protocol for surface control than `visibly
contaminated' " (Document ID 1962, p. 3). The Boeing Company (Boeing)
also requested that "as free as practicable" be replaced with defined
surface contaminant levels (Document ID 1667, pp. 6).
Conversely, the Department of Defense (DOD) commented that
employers should not be required to measure beryllium contamination on
surfaces, as the relationship between level of surface contamination
and health risk is unknown. It also stated that wipe samples are not an
appropriate enforcement tool for determining that surfaces are "as
free as practicable" of beryllium contamination (Document ID 1684,
Attachment 1, p. 1). ORCHSE Strategies (ORCHSE) agreed that OSHA should
not require measurement of beryllium contamination on surfaces
(Document ID 1691, p. 18). And, the American Industrial Hygiene
Association (AIHA) commented that "the evaluation of `visible' is
subjective" (Document ID 1686, p. 1).
After carefully considering these comments and other evidence in
the record, OSHA has chosen not to require employers to measure
beryllium contamination on surfaces, as suggested by KCP, or to
otherwise "define specific surface contaminant levels," as requested
by Boeing Company. As DOD explains in its comments, the relationship
between a precise amount of surface contamination and health risk is
unknown. Therefore, OSHA cannot find that a particular level of
contamination is safe. Rather, OSHA has determined that keeping
surfaces as clean as practicable is appropriate because promptly
removing beryllium deposits prevents them from becoming airborne, thus
reducing employees'
inhalation exposure, and helps to minimize the likelihood of skin
contact with beryllium. The Agency notes, however, that wipe samples
can be a helpful tool for employers. For example, wipe samples can be
used by employers to detect the presence of beryllium on surfaces and
help gauge when surfaces are as free as practicable of accumulations of
beryllium.
Therefore, OSHA has decided to retain the requirement that
employers maintain all surfaces in beryllium work areas as free as
practicable of beryllium in paragraph (j)(1)(i) of the final general
industry standard. The term "as free as practicable" is accepted
language and used in other OSHA housekeeping requirements for toxic
dusts (Asbestos, 29 CFR 1910.1001 and Cadmium, 29 CFR 1910.1027). As
the Agency has explained in a letter of interpretation on this term as
used in the lead standard, "the requirement to maintain surfaces `as
free as practicable' is performance-oriented. . . . The requirement is
met when the employer is vigilant in his efforts to ensure that
surfaces are kept free of accumulations of lead-containing dust. The
role of the Compliance Safety and Health Officer (CSHO) is to evaluate
the employer's housekeeping schedule, the possibility of exposure from
these surfaces, and the characteristics of the workplace" (OSHA, Jan.
13, 2003, Letter of Interpretation.) The term "surface" has a common
meaning but is not separately defined in the standard. This term has
been used multiple times in OSHA's substance specific standards and
OSHA has not found that it is a source of confusion for employers. As
indicated in the preamble to the proposed standard, the term includes
the outer parts of objects that workers come into contact with, such as
equipment, floors, and items in storage facilities, as well as objects
that workers may not directly contact, such as rafters and ledges. See
80 FR 47796. Because all surfaces in beryllium work areas could
potentially accumulate beryllium that could become airborne or that
workers could later inhale, touch, or ingest, all surfaces in beryllium
works areas must be kept as free as practicable of beryllium.
OSHA has also decided to remove the phrase "accumulations of"
from (j)(1)(i), because OSHA believes the reference to
"accumulations" may be misinterpreted to suggest that cleaning is
only required when substantial deposits of beryllium-containing
material have accumulated on surfaces. As discussed previously, dermal
contact with small amounts of beryllium that are not visible to the
naked eye can cause beryllium sensitization. Thus, the final standard
for general industry requires the employer to maintain all surfaces in
beryllium work areas as free as practicable of beryllium and in
accordance with the written exposure control plan required under
paragraph (f)(1) and the cleaning methods required under paragraph
(j)(2) of this standard.
OSHA has not included the requirement that employers maintain all
surfaces in beryllium work areas as free as practicable of beryllium in
the final standards for construction and shipyards because certain
conditions typical in these sectors warrant different approaches in the
housekeeping provisions. As discussed in the Summary and Explanation
for paragraph (a), Scope and application, in this preamble, although
employees in the construction and shipyard industries may be exposed to
beryllium during the demolition of beryllium-contaminated buildings and
metal recycling or through the dressing of non-sparking tools, the
primary exposure source of beryllium at construction worksites and in
shipyards is from abrasive blasting operations (Document ID 1671,
Attachment 1, p. 5; 1756, Tr. 97-99). Specifically, employees in the
construction and shipyard industries are typically exposed when they
use abrasive blasting media that contain beryllium.
Abrasive blasting in the construction and shipyard industries often
occurs outdoors (see the Final Economic Analysis (FEA), Chapter IV. The
surfaces being blasted can be large structures, such as buildings or
ships. The blasting process itself can be transient and may occur for
short periods of time. The work can be performed in the open or in
temporary work enclosures when abrading large objects or structures
that cannot be transported or are fixed. These enclosures are typically
constructed of tarps and regularly moved from newly abraded areas to
areas needing abrasion over very large distances (Document ID 1632, p.
6).
During the abrasive blasting process, large amounts of dust become
airborne and then settle on nearby surfaces. Spent blasting media
containing trace amounts of beryllium is cleaned up after the blasting
operation is complete and has moved to a different area of the
worksite. Paragraph (j)(2) of the construction and shipyard standards
requires employers to ensure that employees use methods that minimize
beryllium exposure during this cleaning process. However, due to the
outdoor location of many worksites in construction and shipyards, OSHA
finds it is not practical to require employers to maintain all surfaces
in work areas as free as practicable of beryllium in construction or
shipyards as for general industry. Therefore, OSHA has not included a
reference to surfaces in the provisions of in paragraph (j)(1)(i) of
the final standards for construction and shipyards. OSHA has modified
paragraph (j)(1)(i) of these standards to require only that the
employer follow the written exposure control plan required under
paragraph (f)(1) when cleaning beryllium-contaminated areas.
When beryllium is released into the workplace as a result of a
spill or emergency release, paragraph (j)(1)(ii) of the final
standards, like paragraph (j)(1)(ii) of the proposal, requires the
employer to ensure prompt cleanup. As defined in paragraph (b) of the
final standards, the term "emergency" means any uncontrolled release
of airborne beryllium. An emergency could result from equipment
failure, rupture of containers, or failure of control equipment, among
other causes. Spills or emergency releases not attended to promptly are
likely to result in additional employee exposure or skin contact.
Boeing objected to the proposed requirement that employers maintain
surfaces and clean up spills or emergency releases in accordance with
the written exposure control plans required by paragraph (f)(1), in
part, because it did not believe OSHA should require employees to
establish a written exposure control plan. Instead, Boeing suggested
the Agency revise the standard to allow employers to use "existing
processes, such as a written beryllium worksite control procedure"
(Document ID 1667, p. 4). To that end, Boeing suggested that employers
be allowed to ensure prompt and proper cleanup in accordance with the
exposure control plan, "or equally as effective documentation"
(Document ID 1667, pp. 6-7). As explained in the Summary and
Explanation for paragraph (f), Methods of Compliance, in this preamble,
OSHA disagrees with Boeing and has chosen to retain the requirement to
establish, implement, and maintain a written exposure control plan.
Final paragraphs (j)(1)(i) and (ii) of the standards, like proposed
paragraphs (j)(1)(i) and (ii), thus require employers to perform
housekeeping activities in accordance with the written exposure control
plan required by paragraph (f)(1) and the cleaning methods required by
paragraph (j)(2) of the standards.
Paragraph (j)(2) of the proposed rule included a few requirements
regarding cleaning methods. Because OSHA recognizes that each work
environment is unique, the Agency proposed
performance-oriented requirements for housekeeping to allow employers
to determine how best to clean beryllium work areas. Paragraph
(j)(2)(i) of the proposed standard would have required that surfaces in
beryllium work areas be cleaned by high-efficiency particulate air
filter (HEPA) vacuuming or other methods that minimize the likelihood
and level of beryllium exposure.
Some commenters, including NJH and USW, expressed support for the
proposed requirement to use HEPA-filtered vacuuming (e.g., Document ID
1664, p. 7; 1681, p. 13). NJH indicated that HEPA-filtered vacuuming is
one of the methods that it recommends using because "it has been shown
to minimize exposures" (Document ID 1664, p. 7). USW added that HEPA
vacuums are common in the manufacturing industry and requiring their
use should not burden employers (Document ID 1681, p. 13). Southern
Company also noted that where beryllium is present as a trace element
in coal-fired power generation, "surfaces are cleaned and kept free of
coal dust and ash by various methods, including vacuuming or washing,"
methods that may already comply with this proposed provision (Document
ID 1668, p. 6).
KCP also indicated its support for HEPA vacuums, stating that
vacuuming with HEPA filters is the safest way to remove dry
contaminants from surfaces (Document ID 1676, Attachment 1, p. 5).
However, KCP added that HEPA vacuums do not always work well in tight
areas with recesses, crevices, and complex arrangements of equipment
components and that workers are likely to use a towel to clean such
areas. Because workers will naturally use nearby towels, KCP
recommended that OSHA specify that towels used to clean surfaces must
be wet, not dry.
The Sampling and Analysis Subcommittee Task Group of the Beryllium
Health and Safety Committee (BHSC Task Group) also expressed concern
with the proposed provision's reliance on HEPA-filtered vacuuming. The
BHSC Task Group observed that although HEPA-filtered vacuuming is
considered to be the most effective method for cleaning surfaces, it is
not necessarily effective in minimizing the spread of contamination
because the vacuums fail in various ways during use. The BHSC Task
Group further suggested that if OSHA were to prescribe HEPA-filtered
equipment use, it should include a requirement for particle counting
during use (Document ID 1665, p. 11).
OSHA finds that HEPA-filtered vacuuming is a highly effective
method of cleaning beryllium-contaminated surfaces. However, the Agency
acknowledges that any housekeeping equipment may fail and that
maintaining the equipment according to the manufacturer's
recommendations can be a critical part of ensuring that it functions as
intended. (See summary and explanation of paragraph (j)(2)(v) which
addresses maintenance of cleaning equipment.) Nevertheless, OSHA
believes that when HEPA vacuums are maintained in proper working
condition, it is not necessary to include a requirement for particle
counting during the vacuuming. In addition, the Agency agrees with KCP
that in certain circumstances other cleaning methods, such as wet
wiping with towels, may also be effective in minimizing the likelihood
and level of airborne exposure. Thus, paragraph (j)(2)(i) of the
general industry standard retains the requirement that employers must
ensure that surfaces in beryllium work areas are cleaned by HEPA-filter
vacuuming or other cleaning methods that minimize the likelihood and
level of airborne exposure. However, as discussed in detail below, OSHA
has also added provisions to accommodate situations where cleaning with
HEPA-filtered vacuums or other cleaning methods that minimize airborne
exposure are not effective.
As explained above, OSHA has chosen not to include a provision
requiring the cleaning of surfaces in the final construction and
shipyard standards. And, as explained in the Summary and Explanation
for paragraph (e), the construction and shipyard standards do not
include a provision establishing beryllium work areas. Thus, references
to surface cleaning and beryllium work areas have been removed from
paragraph (j)(2)(i) of the construction and shipyard standards.
Paragraph (j)(2)(i) in these standards requires employers to ensure the
use of HEPA-filter vacuuming or other methods that minimize the
likelihood and level of airborne exposure when cleaning spent blast
media or performing other cleaning in beryllium-contaminated areas.
Paragraph (j)(2)(ii) of the proposed rule addressed the use of dry
sweeping and brushing for cleaning in beryllium work areas. This
proposed provision would have disallowed the use of dry sweeping and
brushing unless the employer had tried cleaning with a HEPA-filtered
vacuum or another method that minimizes the likelihood and level of
exposure, and found that the method attempted was not effective under
the particular circumstances found in the workplace. As explained in
the proposal, OSHA included this provision to provide employers
flexibility when exposure-minimizing cleaning methods would not be
effective. See 80 FR 47796. However, the Agency indicated it was not
aware of any circumstances in which dry sweeping or brushing would be
necessary and requested comment on whether either of these cleaning
methods would ever be necessary, and if so, under what circumstances.
See 80 FR 47574.
Some commenters expressed general support for the prohibition on
dry sweeping and brushing. For example, Ashlee Fitch, representing USW
and Materion, commented that HEPA vacuums should be used whenever
feasible, and stated that "OSHA has appropriately characterized this
provision relative to exceptions" (Document ID 1680, p. 5). ORCHSE
also agreed that prohibiting dry sweeping or brushing to clean surfaces
in beryllium work areas is appropriate, and that employers should only
be permitted to use dry sweeping and dry brushing when HEPA-filtered
vacuuming have been tried and found not effective (Document ID 1691,
Attachment 1, p. 5).
Commenters AFL-CIO, AWE, the BHSC Task Group, and North America's
Building Trades Unions (NABTU), recommended prohibiting the use of dry
sweeping under any circumstances (Document ID 1689, p. 13; 1615, p. 1,
9; 1655, p. 11; 1679, p. 9). For example, Clive LeGresley of AWE stated
that AWE does not permit dry sweeping or brushing to clean surfaces and
recommended banning this practice (Document ID 1615, p. 1). The BHSC
Task Group recommended that dry sweeping be prohibited because it
disturbs settled beryllium on surfaces, "which can exacerbate airborne
contamination" (Document ID 1655, p. 11). It also argued that dry
sweeping is not an effective cleaning method, and when dry cleaning is
the only available option, dry pickup cloths rather than sweeping
should be used (Document ID 1655, p. 13). The AFL-CIO recommended
strengthening language in the final rule to prohibit dry housekeeping
methods (Document ID 1689, p. 13). In addition, the AFL-CIO pointed out
that under the DOE Chronic Beryllium Disease Prevention Program, 10 CFR
850.30 (Housekeeping), the use of dry methods for cleaning floors and
surfaces in areas where beryllium is present is prohibited (Document ID
1689, p. 13). NABTU argued that there are no circumstances in which dry
sweeping or brushing is necessary, that these practices are unsafe, and
the use of such practices would trigger the need to decontaminate
entire work areas
before any work could be performed (Document ID 1679, p. 9). AFL-CIO
additionally recommended that if dry cleaning methods are necessary due
to feasibility issues, "employers should be required to conduct an
exposure assessment and provide a work process description" (Document
ID 1809, p. 2). OSHA has considered AFL-CIO's comment, and finds that
the requirements for exposure assessment included in paragraph (d) of
the final standards adequately address AFL-CIO's recommendation for
exposure assessment. If an employer uses dry methods for cleaning
beryllium-contaminated surfaces or areas, exposure from these methods
should be included in exposure assessment, and re-assessment of
exposures must be conducted when an employer adopts or changes dry
methods because this could cause new or additional exposures.
In addition, OSHA has considered AFL-CIO's recommendation to
require employers who use dry methods to provide a work process
description, and finds that a work process description provides no
clear benefit to workers using dry methods for cleaning. However, OSHA
notes that paragraph (m) of this standard, which requires training for
every employee who is or can reasonably be expected to be exposed to
airborne beryllium, encompasses any use of dry cleaning methods in the
demarcated beryllium work areas (or, in construction and shipyard
settings, in beryllium-contaminated areas). Paragraph (m)(4) includes
requirements that employees can demonstrate knowledge and understanding
of hazards associated with beryllium exposure, operations that could
result in airborne exposure, and measures employees can take to protect
themselves from airborne exposure to and contact with beryllium. OSHA
intends that employees who use dry methods for cleaning beryllium-
contaminated surfaces or areas must be trained on the potential for
airborne exposure during such cleaning, the hazards associated with
such exposure, and the measures they can take to protect themselves,
including the requirements of final paragraphs (j)(2)(iv) and (j)(2)(v)
discussed later in this section. OSHA finds that these training
requirements serve the purpose of providing information to employees
regarding the work process, hazards and methods of protection related
to dry sweeping, as OSHA believes the AFL-CIO's recommendation
intended.
Several stakeholders cited problems with the use of HEPA-filtered
vacuums or wet methods in particular circumstances, or noted specific
circumstances where they believed the use of dry sweeping was necessary
(Document ID 1676, p. 5; 1668, p. 6; 1807, pp. 2-3; 1756, Tr. 42-43).
For example, as noted above, KCP argued that HEPA-filtered vacuums do
not always work well in tight areas with recesses, crevices, and
complex arrangements of equipment components. Materion commented that
it generally prohibits the use of dry brushing or broom cleaning for
cleaning but, in instances such as machining operations, the use of
paint brushes to clean small chips is required. Materion also noted
that some manufacturing processes may use dry brushes. It added that
when it permits use of a brush, it performs an exposure assessment "to
help ensure the task is well controlled" (Document ID 1807, Attachment
1, pp. 2-3). In addition, Jerrod Weaver from the Non-Ferrous Founders'
Society (NFFS) testified that dry sweeping is "not unusual" in the
foundry industry. He explained that the use of wet sweeping or other
wet cleaning methods would be dangerous in foundries because when water
hits molten metal, it can cause an explosion (Document ID 1756, Tr. 42-
43).
Other stakeholders offered opinions on when the use of dry sweeping
and dry brushing should be constrained. For example, the Southern
Company argued that when dry sweeping does not result in exposure to
beryllium above the action level, it should be considered a feasible
cleaning option (Document ID 1668, p. 6). Similarly, Ameren Corporation
stated that "prohibiting dry sweeping should be based on employee
exposure at or above the action level, not whether it's a beryllium
work area" (Document ID 1675, p. 6). As discussed in Section V, Health
Effects, and Section VI, Risk Assessment, the best available scientific
evidence suggests that adverse health effects such as beryllium
sensitization and CBD can result from airborne exposures below the
action level of 0.1 μg/m3\. In addition, OSHA does not see this
suggestion as a practical solution where employers may feel obligated
to perform exposure monitoring (or exposure assessments) every time
housekeeping functions are performed. OSHA, as it has done in many
other standards (e.g., Chromium (VI), 29 CFR 1910.1026), continues to
believe that a general prohibition is warranted considering the risk
even at the action level.
After carefully reviewing the evidence in the record, OSHA finds
that the use of dry sweeping and dry brushing can contribute to
employee exposure. However, OSHA also finds convincing evidence that
wet methods and HEPA-filtered vacuums may not be safe or effective in
all situations in general industry. For example, wet sweeping in
certain foundry work areas may be effective but is not safe because of
the physical hazard created when water comes into contact with molten
metal. Therefore, the Agency has retained both the prohibition on dry
sweeping and dry brushing and the exceptions to that prohibition in
paragraph (j)(2)(ii) of the final standard for general industry.
Although OSHA has decided not to allow these methods based on a
specific exposure level, OSHA has revised (j)(2)(ii) to clarify that
employers may use dry sweeping or dry brushing to clean surfaces where
HEPA-filtered vacuuming or other appropriate methods that minimize
likelihood and level of exposure are not safe or effective. The
proposed provision merely stated that employers could utilize the dry
sweeping or brushing when HEPA-filtered vacuuming or the other methods
were not "effective." The Agency intended this term to encompass
those situations in which HEPA-filtered vacuuming or the other chosen
method would not accomplish the task at hand, i.e., cleaning, and
situations in which the use of HEPA-filtered vacuuming or the other
methods were unsafe. OSHA has modified the text of the final rule to
make this intent explicit.
In sum, final paragraph (j)(2)(ii) of the general industry standard
states that the employer must not allow dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
airborne exposure are not safe or effective. In situations where HEPA-
filtered vacuuming or other methods that minimize the likelihood and
level of airborne exposure would be ineffective, would cause damage, or
would create a hazard in the workplace, the employer is not required to
use these cleaning methods. The revised paragraph (j)(2)(ii) gives
employers the necessary flexibility to use dry sweeping or dry brushing
in such situations.
Although OSHA is allowing for dry sweeping and brushing, the Agency
anticipates that the number of circumstances where these methods are
necessary will be extremely limited. Where the employer uses dry
sweeping or brushing, the employer must be able to demonstrate that
HEPA-filtered vacuuming or other methods, such as wet sweeping, that
minimize the likelihood or exposure are not safe or effective. To
comply with the final rule, it is enough for employers to demonstrate
that such cleaning methods
are unsafe or ineffective--actually attempting the method on a
particular worksite is unnecessary. However, as in the proposal, the
employer bears the burden of providing that these methods are either
unsafe or ineffective. OSHA has included a similar provision in final
paragraph (j)(2)(ii) of the standards for construction and shipyards.
Like the general industry provision, final paragraph (j)(2)(ii) of the
standards for construction and shipyards disallows dry sweeping and dry
brushing and includes an exception for circumstances where HEPA-
filtered vacuuming, or other methods that minimize the likelihood of
exposure are not safe or effective. Because the construction and
shipyard standards do not include a provision establishing beryllium
work areas, paragraph (j)(2)(i) of these standards requires the
employer to ensure the use of HEPA-filter vacuuming or other methods
that minimize the likelihood and level of airborne exposure when
cleaning beryllium-contaminated areas. Paragraph (j)(2)(ii) states that
the employer must not allow dry sweeping or brushing for cleaning in
beryllium-contaminated areas unless HEPA-filtered vacuuming or other
methods that minimize the likelihood and level of airborne exposure are
not safe or effective.
OSHA notes that methods that minimize the likelihood and level of
airborne exposure other than HEPA vacuuming may be appropriate for use
in construction and shipyards. Use of wet methods, such as wet sweeping
or wet shoveling, or using mechanical equipment to move wetted
material, may be viable alternatives for cleaning large amounts of
spent blasting media used in abrasive blasting operations.
Paragraph (j)(2)(iii) of the proposed rule would have prohibited
the use of compressed air in cleaning beryllium-contaminated surfaces
unless it was used in conjunction with a ventilation system designed to
capture any resulting airborne beryllium. As OSHA indicated in the
proposal, this provision was intended to limit airborne exposure by
preventing the dispersal of beryllium into the air (80 FR 47796).
Stakeholders offered a number of comments on the use of compressed
air. For example, NJH expressed support for this provision, and
emphasized that compressed air should only be used in conjunction with
a ventilation system (Document ID 1664, p. 7). Several commenters
discussed the use of compressed air for cleaning and other processes.
Materion commented that it generally prohibits the use of compressed
air, but production operations may incorporate compressed air into
manufacturing processes (Document ID 1807, Attachment 1, p. 3).
Materion further commented that on the few occasions when it permits
the use of compressed air, it performs an exposure assessment "to help
ensure the task is well controlled" (Document ID 1807, Attachment 1,
p. 3). Mr. Weaver, a representative of NFFS, testified that the use of
compressed air in the foundry industry is "not unusual" (Document ID
1756, Tr. 42). He added that compressed air is useful for cleaning work
surfaces (Document ID 1756, Tr. 42).
Some commenters, including the AFL-CIO, AWE, and United Automobile,
Aerospace & Agricultural Implement Workers of America (UAW), objected
to the use of compressed air for cleaning (Document ID 1615 p. 1; 1689,
p. 13; 1693, p. 4). For example, the AFL-CIO noted that the DOE Chronic
Beryllium Disease Prevention Program prohibits the use of compressed
air and dry methods for cleaning floors and surfaces in areas where
beryllium is present (Document ID 1689, p. 13). And, UAW stated that
"[c]apture hoods capable of reliably controlling particulates pushed
by compressed air do not exist" (Document ID 1693, p. 4).
OSHA has carefully considered these comments and finds that the use
of compressed air to clean beryllium-contaminated surfaces may
occasionally be necessary in general industry; particularly in
manufacturing processes. Therefore, paragraph (j)(2)(iii) of the final
standards allows for the use of compressed air to clean, but only where
the compressed air is used in conjunction with a ventilation system
designed to capture the particulates made airborne by the use of
compressed air. This provision is consistent with other recent
substance-specific standards, such as the standard for respirable
crystalline silica (29 CFR 1910.1053).
Because the standards for construction and shipyards do not include
a provision establishing beryllium work areas, paragraph (j)(2)(iii) of
these standards states that employers must not allow the use of
compressed air for cleaning in beryllium-contaminated areas unless the
compressed air is used in conjunction with a ventilation system
designed to capture the particulates made airborne by the use of
compressed air. OSHA intends this paragraph to apply when using
compressed air to clean, for example, surfaces in work areas, tarps
used for abrasive blasting enclosures, abrasive blasting equipment, and
material designated for recycling or disposal in order to prevent
dispersal of beryllium into workers' breathing zones.
OSHA recognizes that even the limited uses permitted under these
standards of dry sweeping, dry brushing, and compressed air to clean
can result in employee exposure to beryllium. To help mitigate the
potential health risks, OSHA included a provision in the proposed rule
to further protect employees who are using these cleaning methods.
Under proposed paragraph (j)(2)(iv), where employees use dry sweeping,
brushing, or compressed air to clean beryllium-contaminated surfaces,
the employer was required to provide respiratory protection and
protective clothing and equipment and ensure that each employee use
this protection in accordance with paragraphs (g) and (h) of this
standard. As OSHA explained in the proposal, the failure to provide
proper and adequate protection to those employees performing cleanup
activities would defeat the purpose of the housekeeping practices
required to control beryllium exposure. See 80 FR 47796.
In its post-hearing comments, the AFL-CIO indicated support for
this requirement. Specifically, the AFL-CIO argued that if dry
housekeeping methods are permitted, "workers should be provided a N-95
respirator--or a higher level of protection as required based on the
exposure--and personal protective clothing" (Document ID 1809, p. 2).
After considering the record on this issue, OSHA concludes that
requiring employers to provide respiratory protection and protective
clothing and equipment in the limited situations where dry sweeping,
brushing, or compressed air is used is essential to minimize exposure.
Therefore, the Agency has included this provision in paragraph
(j)(2)(iv) of the final standard for general industry. OSHA has also
included a similar provision in paragraph (j)(2)(iv) of the final
standards for construction and shipyards. Proposed paragraph (j)(2)(v)
would have required employers to ensure that equipment used to clean
beryllium from surfaces is handled and maintained in a manner that
minimizes employee exposure and the re-entrainment of beryllium into
the workplace environment. Re-entrainment occurs when particles that
have settled on surfaces become airborne and remain suspended in the
air. Beryllium particles that have been disturbed from surfaces and re-
entrained contribute to employee's airborne beryllium exposure.
Commenters generally supported the inclusion of this provision in the
final rule. For example,
Materion stated that preventing migration of beryllium requires
"looking at all those migratory pathways where material can move
around in an operation," keeping the material as close to the source
as possible, and keeping it off of people and off of surfaces (Document
ID 1755, Tr. 150). The BHSC Task Group commented that HEPA vacuums
"must be maintained per the manufacturer's recommendations and
oriented in such a manner that the exhaust side of the HEPA vacuum is
not blowing hazardous dust into the work area" (Document ID 1655, p.
11). Among other things, the BHSC Task Group said this provision would
cause employers to ensure that cleaning and maintenance of HEPA-
filtered vacuum equipment is done carefully to avoid exposure to
beryllium. This provision would also require employers to ensure that
filter changes and bag and waste disposal be performed in a manner that
minimizes the risk of employee exposure to airborne beryllium and
accidentally dispersing beryllium back into the workplace environment.
After carefully reviewing these comments, OSHA finds that the
provisions of paragraph (j)(2)(v) are necessary to the protection of
employees from the adverse health effects associated with beryllium
exposure, and has decided to include this provision (with minor
changes) in paragraph (j)(2)(v) of the final standards. OSHA notes that
paragraph (j)(2)(v) complements paragraph (f)(1)(i)(F), which requires
employers to establish and implement a written exposure control plan
that includes procedures for minimizing the migration of beryllium.
Paragraph (j)(3)(i) of the proposed rule would have required the
employer to ensure that waste, debris, and materials visibly
contaminated with beryllium and consigned for disposal were disposed of
in sealed, impermeable enclosures, such as bags or containers.
Paragraph (j)(3)(ii) would have further required such bags or
containers to be labeled in accordance with paragraph (m)(3) of the
proposed rule. Finally, paragraph (j)(3)(iii) of the proposed rule
would have required materials designated for recycling that are visibly
contaminated with beryllium to be either cleaned to remove visible
particulate, or placed in sealed, impermeable enclosures, such as bags
or containers, that are labeled in accordance with paragraph (m)(3) of
the proposed rule.
OSHA intended these provisions to protect and inform workers who
may be exposed to beryllium when handling waste or recycled materials.
As discussed in the NPRM, alerting employers and employees who are
involved in disposal to the potential hazards of beryllium exposure
will better enable them to implement protective measures (80 FR 47771).
OSHA reasoned that employers and employees should be similarly alerted
if handling materials designated for recycling that have not been
cleaned of visible particulate. The proposed requirements to use
impermeable enclosures and/or clean materials of visible particulate
were intended to reduce employees' risk of beryllium sensitization from
dermal contact with beryllium in handling waste materials or materials
designated for recycling. The options provided to employers in proposed
paragraph (j)(3)(iii) were intended to allow employers flexibility to
facilitate the recycling process.
In the NPRM, OSHA asked for feedback on proposed paragraph (j)(3)
(80 FR 47574). A number of stakeholders responded. For example, NFFS
argued that:
[t]he sections regulating the manner in which waste product is
labeled, packaged and shipped have already been regulated by both
the [Environmental Protection Agency (EPA) (e.g. treatment,
recycling and reuse of waste materials) and the DoT (e.g. shipping
and placarding requirements, shipping containers for hazardous
materials). Additionally, scrap and process coproducts in the non-
ferrous foundry industry are treated as products and provided with
appropriate labeling and SDS information as required by OSHA and the
GHS/Hazard Communication standard. Requiring the non-ferrous casting
industry to treat our process coproducts the same as waste and
debris streams contradicts the requirements of the EPA and DoT
regarding the identification, processing, packing, handling and
transportation requirements of these materials" (Document ID 1678,
p. 5).
OSHA's requirement for warning labels must be consistent with the
Hazard Communication Standard. Therefore, OSHA is not convinced that
these are barriers to appropriately warning downstream users of
beryllium contamination. In the Hazard Communication Standard (HCS),
OSHA has carefully defined when other Agencies have jurisdiction for
labeling requirements such as EPA and the Department of Transportation
(DOT). Additionally, as OSHA further explainsed in the Summary and
Explanation for paragraph (m), Communication of hazards, OSHA intends
for the hazard communication requirements in the final standards to be
substantively as consistent as possible with the HCS, while including
additional specific requirements needed to protect employees exposed to
beryllium, in order to avoid duplicative administrative burden on
employers who must comply with both the HCS and this rule. To that end,
OSHA allows employers to include the information required by these
beryllium standards on the labels created to comply with the HCS. Thus,
if NFFS's members are already supplying labels that conform to the HCS,
they can add the beryllium-specific information to the existing labels.
OSHA deems this information is warranted and would not contradict or
cast doubt on the other information required on the label.
Some commenters, including USW, generally agreed with OSHA's
proposed disposal and recycling requirements (e.g., Document ID 1680,
p. 6). Materion noted that a similar provision appeared in Materion and
the USW's joint draft model standard (Document ID 1681, p. 12). In
addition, Materion argued that OSHA should not require that all
material to be recycled be decontaminated regardless of perceived
surface cleanliness or require that all material disposed or discarded
be in enclosures regardless of perceived surface cleanliness (Document
ID 1681, p. 12). The company maintained that this requirement would be
technologically and economically infeasible and extremely costly in
many regards, particularly with regard to surface residue from abrasive
blasting (Document ID 1681, p. 12). As discussed below, OSHA has
decided for the construction and shipyard standards not to require
decontamination or enclosure of materials designated for recycling or
disposal due in part to concerns about the feasibility of such
requirements in these sectors.
However, many other stakeholders argued in favor of cleaning or
enclosing all beryllium-contaminated materials designated for recycling
and enclosing such materials destined for disposal. For example, the
BHSC Task Group, NJH, the National Institute for Occupational Safety
and Health, Southern Company, NFFS, AIHA, NABTU, and ORCHSE disagreed
with the proposal's use of the term "visible" when determining
whether the provisions for containment and labeling included in
proposed paragraph (j)(3) should apply to materials designated for
recycling or disposal (e.g., Document ID 1664, p. 7; 1671, Attachment
1, p. 7; 1668, p. 6; 1678, p. 5; 1686, p. 2; 1679, p. 10; 1691, p. 5).
NJH and ORCHSE recommended that OSHA require all materials designated
for recycling "be decontaminated regardless of perceived surface
cleanliness" (Document ID 1664, p. 7; 1691, p. 5). NJH added that
"particles may not be visible to the naked eye" and
"[d]econtaminating all
materials ensures that exposure is minimized." It also recommended
that materials designated for disposal be discarded per local hazardous
waste regulations (Document ID 1664, p. 7). ORCHSE argued that for the
protection of municipal and commercial disposal workers, materials
discarded from beryllium work areas should be in bags or other
containers (Document ID 1691, p. 5). NFFS asserted that "visibly
contaminated," "cleaned to remove visible particulate," and
"sealed, impermeable enclosures" are vague terms (Document ID 1678,
p. 5).
As discussed previously in the Summary and Explanation for
paragraph (h), Personal protective clothing and equipment, in this
preamble, OSHA finds that "visibly contaminated" is a subjective
trigger for most purposes in the final standards, and dermal contact
with beryllium can cause beryllium sensitization even if the beryllium
is not visible to the naked eye. OSHA therefore agrees with the
commenters who criticized the use of "visibly contaminated." (see,
e.g. Document ID 1686, p. 1). The Agency intends that waste, debris,
and materials be disposed of as specified in paragraph (j)(3)
regardless of particulate visibility. However, OSHA does not intend for
this requirement to extend to articles containing beryllium that are
outside of the scope the standard, but to beryllium dust generated
during processing. Similarly, materials designated for recycling must
be cleaned to remove particulate or placed in sealed, impermeable
enclosures, such as bags or containers, and labeled in accordance with
paragraph (m)(3) of the standards, regardless of particulate
visibility. To make this intention clear to employers, OSHA has removed
the terms "visibly" and "visible" from paragraph (j)(3) of the
final standard for general industry, and has replaced them with "as
free as practicable." OSHA discusses the meaning of "as free as
practicable" and addresses comments on this phrase in this Summary and
Explanation of paragraph (j), Housekeeping.
OSHA also agrees with ORCHSE that materials discarded from
beryllium work areas in general industry should be in bags or other
containers for the protection of municipal and commercial disposal
workers (Document ID 1691, p. 5). However, OSHA disagrees with NFFS's
comment that "sealed, impermeable enclosures" is problematically
vague (Document ID 1678, p. 5). OSHA intends this term to be broad and
the provision performance-oriented, so as to allow employers in a
variety of industries flexibility to decide what type of enclosures
(e.g., bags or other containers) are best suited to their workplace and
the nature of the beryllium-containing materials they are disposing or
designating for reuse outside the facility. OSHA finds that the terms
"sealed" and "impermeable" are commonly understood and should not
cause employers confusion. OSHA intends these terms to mean that the
enclosures selected should not allow the materials they contain to
escape the enclosures under normal conditions of use.
In addition, the BHSC Task Group stated that certain beryllium-
contaminated items should not be considered for recycling. According to
the BHSC Task Group, only materials scheduled for use within beryllium
regulated areas at other facilities, and not by the general public,
should be recycled. The BHSC Task Group recommended surface wipe
sampling to determine whether items should be decontaminated again and
should be resampled prior to recycling; otherwise, if not meeting
established limits, they should be disposed of according to
"appropriate waste management practices" (Document ID 1655, p. 13).
After careful consideration, OSHA has decided not to adopt the BHSC
Task Group's suggestion. The Agency finds that the requirement to
either clean and label or enclose and label beryllium-contaminated or
containing materials designated for recycling should provide protection
for later recipients of these items, as discussed in more detail below.
In addition to the previously discussed changes to the proposed
rule, which were directly related to comments received by OSHA, the
Agency has made several changes to better implement and communicate the
intention of paragraph (j)(3). First, OSHA has modified the provisions
of paragraph (j)(3) to state that it applies to materials that contain
beryllium as well as materials contaminated with beryllium. OSHA finds
that employers and employees who work with materials that were recycled
or discarded by other facilities should be made aware of any beryllium-
containing materials they process. Provisions to ensure awareness of
beryllium in materials received from other facilities aid employers who
otherwise might not know they are required to comply with the beryllium
standard, and employees who otherwise might not be appropriately
protected or adequately informed about potential beryllium exposures in
their workplace.
Second, the requirements of (j)(3) regarding labeling materials
designated for recycling have been modified. While the proposed rule
required materials designated for recycling to be labeled in accordance
with paragraph (m)(3) only if employers choose to enclose rather than
clean them, the final standards require employers to label materials
designated for recycling in either case. This modification, like OSHA's
addition of the reference to beryllium-containing materials discussed
above, ensures that employers and employees who work with materials
that were recycled by other facilities are aware of any beryllium-
containing materials they process. OSHA also modified the requirements
of proposed paragraph (j)(3) for the construction and shipyard sectors.
Paragraph (j)(3) of the construction and shipyard standards requires
employers who transfer materials containing beryllium to another party
for use or disposal to provide the recipient with a copy of the warning
described in paragraph (m)(3) of the standards, for the same reasons
this requirement was retained in the final general industry standard.
However, employers in construction and shipyards are not required to
place beryllium-containing materials in sealed, impermeable enclosures
for use or disposal by other entities. OSHA made this change from
paragraph (j)(3) of the general industry standard because the Agency
believes that spent media from abrasive blasting operations will
constitute the great majority of beryllium-containing materials
designated for disposal or recycling in construction and shipyards and
it is generally not practical for employers to enclose spent blasting
media in sealed, impermeable bags or containers, because of the large
volume of waste material generated in these operations OSHA finds that
requiring employers in construction and shipyards to include a warning
label on beryllium-containing materials designated for disposal or
reuse, but not requiring them to seal such materials in impermeable
enclosure, appropriately informs recipients of the potential hazards of
handling the materials without imposing impractical containment
requirements on these employers. In addition, these separate
requirements for construction and shipyards are responsive to
Materion's concern regarding the technological and economic feasibility
of cleaning or enclosing materials contaminated with surface residue
from abrasive blasting.
In summary, paragraph (j)(3)(i) of the final standard for general
industry requires that items containing or contaminated with beryllium
and designated for disposal be disposed of
in sealed, impermeable bags or other sealed, impermeable containers,
and requires these containers to be marked with warning labels in
accordance with paragraph (m)(3) of the standards. Paragraph (j)(3)(ii)
of the final standard for general industry requires materials
designated for recycling that contain or are contaminated with
beryllium be cleaned to be as free as practicable of surface beryllium
contamination and labeled in accordance with paragraph (m)(3) of this
standard, or to be placed in sealed, impermeable enclosures, such as
bags or containers, that are so labeled. Paragraph (j)(3) of the
construction and shipyard standards requires employers who transfer
materials containing beryllium to another party for use or disposal to
provide the recipient with a copy of the warning described in paragraph
(m)(3) of these standards. The term "use" is intended to include
recycling, as well as any other use the recipient may make of the
beryllium-containing materials.
Finally, USW and Materion requested that OSHA make it clear that
this provision does not apply to beryllium-containing scrap metals
being reused within the facility (Document ID 1680, p. 6; 1661 p. 12).
USW offered the example of copper beryllium machine turnings being
utilized within the same facility. The union explained: "In this
example, it would not make sense to require cleaning or enclosing
because they are either very clean to start with or have a thin coating
of machining coolant. Requiring them to be cleaned before reuse in the
facility might actually lead to greater worker exposures" (Document ID
1680, p. 6).
OSHA did not intend to require employers to clean or enclose
materials designated for reuse elsewhere in the same facility.
Therefore, OSHA clarifies that paragraph (j)(3)(ii)'s requirements do
not apply to scrap metals designated for reuse within the same
facility.
(k) Medical Surveillance
Paragraph (k) of the final standards sets forth requirements for
the medical surveillance provisions. The paragraph specifies which
employees must be offered medical surveillance, as well as the
frequency and content of medical examinations. It also sets forth the
information that the licensed physician and CBD diagnostic center is to
provide to the employee and employer. Many of the provisions in the
final standards are substantively consistent with the 2012 joint draft
recommended standard by Materion Corporation (Materion) and the United
Steelworkers (USW) (Document ID 0754).
The purposes of medical surveillance for beryllium are: (1) To
identify beryllium-related adverse health effects so that appropriate
intervention measures can be taken; (2) to determine if an employee has
any condition that might make him or her more sensitive to beryllium
exposure; and (3) to determine the employee's fitness to use personal
protective equipment such as respirators. The inclusion of medical
surveillance in these final standards is consistent with section
6(b)(7) of the OSH Act (29 U.S.C. 655(b)(7)), which requires that,
where appropriate, medical surveillance programs be included in OSHA
health standards to aid in determining whether the health of employees
is adversely affected by exposure to the hazards addressed by the
standard. Almost all other OSHA health standards, such as Chromium (VI)
(29 CFR 1910.1026), Methylene Chloride (29 CFR 1910.1052), Cadmium (29
CFR 1910.1027), and Respirable Crystalline Silica (29 CFR 1910.1053),
have also included medical surveillance requirements and OSHA finds
that a medical surveillance requirement is appropriate for the
beryllium standards because of the health risks resulting from
exposure.
General. Consistent with the proposed standards, paragraph
(k)(1)(i) of the final standards, requires employers to make medical
surveillance available at no cost, and at a reasonable time and place,
for each employee who meets a trigger for medical surveillance. As in
previous OSHA standards, the "no cost, and at a reasonable time and
place" requirement in the final beryllium standards is intended to
encourage employee participation. Under this requirement, if
participation requires travel away from the worksite, the employer will
be required to bear the cost of travel, and employees will have to be
paid for time spent taking medical examinations, including travel time.
OSHA clarifies that employees of beryllium vendors who qualify for
benefits under the Energy Employees Occupational Illness Compensation
Program Act (EEOICPA) (42 U.S.C. 7384-7385s-15) and its implementing
regulations (20 CFR part 30) may also qualify for medical surveillance
benefits under this final standard. Medical benefits provided to
covered employees for covered beryllium diseases under the EEOICPA
program are paid for by the federal government.
Employees covered by both the EEOICPA program and this final
standard will not be required to choose between the programs. Rather,
these dual-coverage employees may undergo medical examinations where
they can receive the services and/or treatment covered under both
programs. Treatment and services for covered beryllium disease of a
covered beryllium employee under the EEOICPA program will be paid for
by the federal government to the extent that the services provided are
covered under the EEOICPA program. If this final standard requires
services or treatment that are not covered by the EEOICPA program, the
employer will be required to pay for these additional services.
OSHA received numerous comments during the public comment period
regarding the inclusion of the medical surveillance provision for the
beryllium standard. Most comments supported inclusion of medical
screening or surveillance in the final beryllium standard, including
those from National Safety Council (NSC), Materion, National Jewish
Health (NJH), North America's Building Trades Union (NABTU), USW, the
American College of Occupational and Environmental Medicine (ACOEM),
the American Thoracic Society (ATS), the American Federation of Labor
and Congress of Industrial Organizations (AFL-CIO), ORCHSE Strategies
(ORCHSE), the National Institute of Occupational Safety and Health
(NIOSH), and Public Citizen (e.g., Document ID 1612, p. 3; 1661, p. 10;
1664, pp. 1, 8; 1679, pp. 11-12; 1681, pp. 13-14; 1685, p. 4; 1688, p.
2; 1689, pp. 13-14; 1691, Attachment 1, pp. 5-13; 1725, p. 33; 1964, p.
3). No commenters opposed the inclusion of a medical surveillance
requirement.
In support of medical surveillance, the AFL-CIO and others
indicated that medical surveillance is essential in screening for
sensitization and preventing CBD (Document ID 1658, p. 3; 1689, p. 13).
As noted in Section V, Health Effects, employees in the early stages of
beryllium disease are often asymptomatic, and as a result, medical
surveillance is critical to identify those employees who may benefit
from interventions such as removal from exposure. ATS also commented
that medical surveillance helps to identify those with sensitization
and potentially CBD, as well as to define the risk of various work
exposures, jobs, and tasks (Document ID 1688, p. 3). Commenter Evan
Shoemaker said surveillance could "inform employers that workplace
controls and safeguards need updating" (Document ID 1658, p. 3).
NJH commented that early disease detection, before symptoms occur,
is the cornerstone for managing work-related disease (Document ID 1806,
pp. 2-3). Studies highlighted by NJH show that medical surveillance
could be important for identifying workers that might
benefit from removal from exposure. Those studies show that rates of
CBD development in sensitized workers are lower for short-term than
long term workers (1.4% versus 9.1% in a study by Henneberger et al.,
2001, Document ID 1313). Other studies it cited showed improvements in
gas exchange and radiography with decreased peak air concentrations of
beryllium (Sprince et al., 1978, as cited in Document ID 1806) and
improvements in lung function in most patients after stopping beryllium
exposures (Sood et al., 2004, Document ID 1331).
NJH also submitted evidence showing that once employees do develop
symptoms, the knowledge that the symptoms are caused by CBD could lead
to treatment to improve outcome (Document ID 1806, pp. 2-3). NJH found
that identifying disease at an early stage allows the use of inhaled
corticosteroids for mild symptoms, which it found to be effective for
reducing expected levels of lung function decline and improving lung
function and cough in employees with lower lung function (Document ID
1811, Attachment 8). Early detection of beryllium disease and
identification of employees who would benefit from oral corticosteroid
treatment before fibrosis develops can result in regression of signs
and symptoms and possibly prevent progression of the disease (Marchand-
Adam et al., 2008, Document ID 0370; 80 FR 47588). NJH concluded that
early detection of beryllium disease allows for exposures to be
decreased and symptoms to be treated at the earliest time point, which
can result in decreases in medication doses, side effects, and risk of
disease progression.
In paragraphs (k)(1)(i)(A)-(C) of the proposal, OSHA specified that
employers must "make medical surveillance as required by this
paragraph available" for each employee: (1) Who has worked in a
regulated area for more than 30 days in the last 12 months; (2) showing
signs or symptoms of CBD, such as shortness of breath after a short
walk or climbing stairs, persistent dry cough, chest pain, or fatigue;
or (3) exposed to beryllium during an emergency. OSHA requested
comments on these triggers and also presented alternatives to expand
eligibility for medical surveillance to a broader group of employees
(80 FR 47565, 47571, 47576). Under Regulatory Alternative #14, medical
surveillance would have been available to employees who are exposed to
beryllium above the proposed permissible exposure limit (PEL),
including employees exposed for fewer than 30 days per year. Regulatory
Alternative #15 would have expanded eligibility for medical
surveillance to employees who are exposed to beryllium above the
proposed action level, including employees exposed for fewer than 30
days per year.\39\ OSHA requested comment on these alternatives.
---------------------------------------------------------------------------
\39\ OSHA also proposed Regulatory Alternative #21, which would
have extended eligibility for medical surveillance to all employees
in shipyards, construction, and general industry who meet the
criteria of proposed paragraph (k)(1) (or any of the alternative
criteria under consideration). However, under Regulatory Alternative
#21, all other provisions of the standard would have been in effect
only for employers and employees that fell within the scope of the
proposed rule. As discussed in the Summary and Explanation for
paragraph (a), Scope and application, OSHA has decided to expand the
proposal's scope to cover construction and shipyards. Therefore,
Regulatory Alternative #21 is moot.
---------------------------------------------------------------------------
OSHA received numerous comments related to each of the proposed
triggers. First, a number of stakeholders commented on the proposed
trigger of working in a regulated area, i.e., an area in the workplace
where an employee's exposure exceeds, or can reasonably be expected to
exceed, either the PEL or the short-term exposure limit (STEL), for
more than 30 days in a 12-month period. For example, NIOSH argued that
employees exposed above an action level of 0.1 µg/m3\ for 30
days a year should be eligible for medical surveillance because
"substantial risk for [sensitization] and [chronic beryllium disease
(CBD)] exists even at the [a]ction [l]evel" (Document ID 1725, p. 32;
1755, Tr. 40). Public Citizen also advocated for an action level
trigger based on risk of sensitization below the proposed PEL, arguing
that triggering medical surveillance at the PEL, where significant risk
remains, would be inconsistent with other OSHA health standards
(Document ID 1964, p. 3). Public Citizen asked OSHA to consider the
feasibility of making medical surveillance available to employees
exposed at any level of beryllium for any duration of time (Document ID
1964, p. 3).
ATS and NJH supported expanding medical surveillance to all
employees exposed to beryllium in beryllium work areas (above or below
the action level), because of remaining significant risk at the PEL and
because exposure monitoring is sporadic and may not always reflect
higher exposures (Document ID 1664, p. 1; 1688, pp. 2, 4). Lisa Maier,
M.D., from NJH further indicated that medical surveillance should be
offered to these employees, regardless of the amount of time they spend
in the work areas (Document ID 1756, Tr. 101-103). To support this
recommendation, NJH referenced three studies (Henneberger et al., 2001,
Document ID 1313; Schuler et al., 2005, (0919); and Taiwao et al, 2008,
(1264)) that examine relationships between beryllium exposure and
development of sensitization and CBD. NJH stated that exposure levels
as low as 0.01 μg/m3\ were associated with the development of
sensitization and disease (Document ID 1720; 1756, Tr. 93-94). NJH also
presented evidence showing that some individuals are genetically
susceptible to developing beryllium sensitization and CBD (e.g., Maier
et al., 2003, Document ID 0484; 1720, p. 3).
The National Supplemental Screening Program (NSSP), an organization
that provides medical screening for former Department of Energy
workers, and ACOEM supported an action level trigger, including for
employees exposed for less than 30 days a year (Document ID 1677, p. 3;
1685, p. 4; 1756, Tr. 83-84). However, Lee Newman, MD, who represented
ACOEM at the public hearing, testified that he personally felt that
medical surveillance should be offered to anyone who has worked in a
beryllium work area with measurable beryllium exposures (Document ID
1756, Tr. 84). Dr. Newman stated that his personal opinion was based
upon his "30 years of experience of working with people [exposed to
beryllium" and "the studies that [he and his colleagues] have done"
(Document ID 1756, Tr. 84).
In contrast, Materion argued medical surveillance should be
triggered by exposures above the PEL because Johnson et al. (2001)
(Document ID 1505) concluded that 2.0 μg/m3\ is sufficient to
protect employees from developing clinical CBD, most recent scientific
studies suggest that 0.2 μg/m3\ is sufficient to protect against
CBD, and the coke oven emissions standard and formaldehyde standards
trigger medical surveillance at the PEL (Document ID 1661, p. 10). NGK
Metals Corporation (NGK) was also opposed to setting the medical
surveillance trigger at the action level, claiming that this would be
burdensome, costly, and cause distress in employees who receive false
positive results (Document ID 1663, p. 5). The Department of Defense
(DOD) argued that medical surveillance should be triggered above the
PEL to monitor the effectiveness of engineering controls and
respiratory protection (Document ID 1684, Attachment 2, p. 1-9).
Based on the comments and other record evidence, OSHA finds that
triggering medical surveillance at the action level of 0.1 μg/m3\
better addresses residual significant risk and varying susceptibility
of employees that can result in sensitization and CBD at lower exposure
levels. OSHA disagrees
with Materion that a PEL trigger for medical surveillance is
sufficiently protective because OSHA's own risk assessment shows
significant risk remaining at the action level and PEL (see Section VI,
Risk Assessment). In addition, OSHA is aware of individuals who are
genetically predisposed to developing beryllium sensitization and CBD
at beryllium levels that would not cause disease in other individuals
(See Section V, Health Effects). As a result, OSHA is concerned that a
PEL trigger is not sufficient to identify disease at an early stage in
employees who are genetically susceptible to developing disease.
Moreover, OSHA finds that an action level trigger for medical
surveillance encourages employers to maintain exposures below that
level, which in turns provides reasonable assurance that exposures will
not exceed the PEL on days when exposures are not measured (See Summary
and Explanation for paragraphs (b), Definitions, and (d), Exposure
Assessment). Therefore, an action level trigger in these standards is
also appropriate to address stakeholder concerns, such as those raised
by ATS and NJH, that exposure assessments might underestimate actual
exposures due to variability in exposure levels or other factors.
Medical surveillance triggered by the action level is the norm for
OSHA health standards. Materion noted two exceptions, observing that
medical surveillance is not triggered at the action level in standards
for formaldehyde and coke oven emissions. However, the Coke Oven
Emissions standard does not include an action level, and the trigger
for medical surveillance is employment in a regulated area, which is a
discretely identified area on or around the coke oven battery, for at
least 30 days a year (29 CFR 1910.1029). Significantly, the Coke Oven
Emissions standard requires employers to assure that no employee in the
regulated area is exposed to coke oven emissions at concentrations
greater than the PEL (29 CFR 1910.1029(c)). Therefore, the trigger in
the Coke Oven Emissions standard, which would include employees who are
exposed to levels no higher than the PEL for at least 30 days per year,
is more protective than a requirement that does not trigger medical
surveillance until exposures exceed the PEL for 30 days a year. With
the exception of formaldehyde, OSHA standards trigger medical
surveillance at exposure levels at or below the PEL, and typically at
the action level.
In sum, OSHA is persuaded that a lower trigger for medical
surveillance is necessary because of the remaining health risk at both
the action level and PEL. However, OSHA is not persuaded by those
commenters who advocated triggering medical surveillance below the
action level, in part, because nearly everyone in the general
population is potentially exposed to beryllium as it is a naturally
occurring compound in rocks and soil. In addition, the lack of
conclusive evidence of non-industrial-related beryllium-related disease
in the record suggests there is a level of exposure at which the risk
of developing beryllium-related disease becomes negligible, but OSHA
does not have information to precisely determine that level. As a
result, offering medical surveillance to all potentially exposed
employees would result in some low-risk employees receiving medical
examinations when they have very little likelihood of benefiting from
those examinations. OSHA is especially concerned by this because some
medical examination components, such as the BeLPT, are invasive. In
addition, OSHA finds that triggering surveillance at a level that is
achievable for some employers is important because it provides
employers with an incentive to keep exposures low to avoid the costs of
providing medical surveillance. Employees benefit from those lower
exposures because it reduces their risk of developing disease.
Triggering medical surveillance at any level of exposure eliminates the
incentive to keep exposures low and thus may be counterproductive to
protecting employees.
In conclusion, an action level trigger is appropriate because it is
a level at which risks are measurable and found to be lower than at the
PEL, especially for employees who may be more susceptible to developing
disease. The action level is achievable for many employers, and those
employers are likely to maintain exposures below the action level to
avoid the costs associated with exposure assessments and offering
medical surveillance. Maintaining exposures below the action level also
benefits employees because it decreases the chances that exposures will
not exceed the PEL on a day on which exposure assessments are not
conducted, and it lowers the risk of developing disease. For those
reasons, an action level trigger is appropriate in the beryllium
standard, consistent with the majority of OSHA standards.
Comments were also received on the 30-day duration as part of the
medical surveillance trigger. NIOSH supported it (Document ID 1725, p.
32; 1755, Tr. 40). However, NJH, NSSP, and ACOEM did not support OSHA's
proposed duration trigger of more than 30 days a year, stating that
eligible employees exposed less than 30 days a year should be offered
medical surveillance (Document ID 1664, p. 9; 1677, p. 3; 1685, p. 4).
Other stakeholders did not support extending medical surveillance
to employees exposed for fewer than 30 days per year. For example, DOD
commented that "[w]hile it is conceivable that workers can be
sensitized to beryllium after brief exposures, it is unlikely that
infrequent, brief exposures will cause either sensitization or chronic
beryllium disease" (Document ID 1684, Attachment 2, p. 1-2).
After careful consideration of these comments and other evidence in
the record, OSHA finds that maintaining the 30-day exposure-duration
trigger is appropriate in the final standards because the Agency's risk
assessment shows increasing risk of health effects from exposure at
increasing cumulative exposures, which considers both exposure level
and duration (See Section VI, Risk Assessment). OSHA finds that a 30-
day trigger is a reasonable benchmark for capturing increasing risk
from cumulative effects caused by repeated exposures. Including a 30-
day exposure-duration trigger also maintains consistency with other
OSHA standards, such as Chromium (VI) (29 CFR 1910.1026), Cadmium (29
CFR 1910.1027), Lead (29 CFR 1910.1025), Asbestos (29 CFR 1910.1001),
and Respirable Crystalline Silica (29 CFR 1910.1053). As discussed in
more detail below, OSHA notes that the triggers in final paragraphs
(k)(1)(i)(B) and (C) may address employees who could be at risk, even
though they may not have had repeated exposures.
Therefore, OSHA has decided to revise the first proposed medical
surveillance trigger to require the offering of medical surveillance
based on exposures at or above the action level, rather than the PEL
(i.e, work in a regulated area). But the Agency will retain the 30-day-
per-year-exposure-duration trigger. In addition, OSHA has chosen to
revise the proposed trigger to require employers to make medical
surveillance available to each employee "who is or is reasonably
expected to be exposed . . . for more than 30 days a year," rather
than waiting for the 30th day of exposure to occur. OSHA made this
revision because the proposed provision, in combination with paragraph
(k)(2)(i)(A), may not have resulted in timely medical examinations for
new employees who are not exposed to beryllium concentrations above the
action level every day. For example, a new employee exposed to
beryllium once per week would not receive a
medical examination until being employed for up to 34 weeks. As noted
below, several stakeholders commented that a medical exam should be
offered before or within 30 days of placement (e.g., Document ID 1664,
p. 7; 1685, p. 4, 1689, p. 13). OSHA agrees that a medical examination
should be conducted shortly after placement to allow the employee to
find out if he or she has any condition that may make him or her more
sensitive to beryllium exposure. For these reasons, paragraph
(k)(1)(i)(A) of the final standards require that employers make medical
surveillance available to each employee who is or is reasonably
expected to be exposed above the action level for more than 30 days per
year.
The proposal's "regulated area" trigger corresponded to setting
the trigger at the PEL, and so has been superseded by the final rule's
action level trigger. The elimination of the "regulated area" trigger
may also affect whether employees exposed above the short-term exposure
limit (STEL) receive medical surveillance. As noted above and discussed
extensively in the Summary and Explanation for paragraph (e), the
proposed standard defined the term "regulated area" to mean an area
that the employer must demarcate, including temporary work areas where
maintenance or non-routine tasks are performed, where an employee's
exposure exceeds, or can reasonably be expected to exceed, either of
the permissible exposure limits (PELs). Proposed paragraphs (c) and (e)
made clear that this definition included both the proposed 8-hour TWA
PEL and the proposed STEL. Because the revised trigger in final
paragraph (k)(1)(i)(A) focuses on the action level, rather than working
in a regulated area, it does not directly require medical surveillance
for employees who are exposed above the STEL, provided their airborne
exposure levels do not exceed the action level for more than 30 days
per year.
However, as explained in Chapter IV-Section 15 of the Final
Economic Analysis and discussed in the Summary and Explanation for
paragraph (c), Permissible Exposure Limits (PELs), the occurrence of
one or more short-term exposures to elevated airborne concentration
during a work shift can substantially increase a worker's 8-hour TWA
exposure. For example, the TWA exposure of a worker who is exposed to a
background level at the final action level of 0.1 μg/m3\ will be
0.16 μg/m3\ if that worker is exposed to a single 15-minute period
at an exposure level just above 2.0 μg/m3\, the final STEL.
Therefore, OSHA finds that the revised action level trigger will
frequently address the STEL component of the proposed trigger because
when exposures exceed the STEL, it is very likely that the action level
will also be exceeded, thus triggering medical surveillance.
Signs or Symptoms. Proposed paragraph (k)(1)(i)(B)) required
employers to "make medical surveillance as required by this paragraph
available" to each employee showing signs or symptoms of CBD, such as
shortness of breath after a short walk or climbing stairs, persistent
dry cough, chest pain, or fatigue. As OSHA explained in the proposal, a
sign-or-symptoms trigger is necessary, in part, because beryllium
sensitization and CBD could develop in employees who are especially
sensitive to beryllium, may have been unknowingly exposed, or may have
been exposed to greater amounts than the exposure assessment suggests.
A signs-or-symptoms trigger was also included in the draft standard
submitted by Materion and USW (Document ID 0754).
One commenter, ORCHSE, argued that a symptom trigger should only
apply to confirmed positive, i.e., sensitized, employees because the
types of symptoms listed are non-specific for CBD and would require
employers to offer medical surveillance to employees who were never
exposed to beryllium (Document ID 1691, Attachment 1, pp. 5-6).
However, the majority of the stakeholders who opined on the signs-or-
symptoms trigger supported its inclusion in the final rule. For
example, NJH, ATS, and NIOSH supported a symptom trigger for medical
surveillance (Document ID 1664, p. 4, 8; 1688, p. 3; 1725, p. 32).
ACOEM and NJH indicated that skin symptoms should trigger medical
examinations for employees exposed to beryllium (Document ID 1664, p.
4; 1685, p. 4). NJH and ACOEM also offered examples of specific
symptoms or signs of skin disease, including rashes or nodules and
dermatitis that is unresponsive to treatment but responsive to removal
from exposure (Document ID 1664, pp. 4, 8; 1688, p. 3; 1725, p. 32). In
addition, United Kingdom defense contractor, AWE, indicated that it
allows its employees with "insignificant likelihood of exposure" to
undergo a medical examination if they report symptoms (Document ID
1651, p. 10).
After carefully considering these comments, OSHA reaffirms its
preliminary finding that the proposed signs-or-symptoms trigger serves
as a valuable complement to the use of airborne exposure triggers as a
mechanism for initiating medical surveillance. A signs-or-symptoms
trigger is appropriate for employees covered by the standard because
the risk of material impairment of health remains significant at the
action level (see Section VI, Risk Assessment). Consequently, even
employees exposed at the action level for fewer than 30 days in a year
may be at risk of developing CBD and other beryllium-related diseases
and adverse health effects. In addition, beryllium sensitization and
CBD could develop in employees who are especially sensitive to
beryllium, may have been unknowingly exposed, or may have been exposed
to greater amounts than the exposure assessment suggests. By requiring
covered employers to make a medical exam available when an employee
exhibits signs or symptoms, the final standard protects all employees
who may have developed CBD, including employees who have been exposed
to beryllium in an emergency or for less than 30 days above the action
level.
OSHA also finds that signs or symptoms of beryllium-related health
effects other than CBD should also trigger medical surveillance (see
Section V, Health Effects). As noted by NJH and ACOEM, these signs or
symptoms can be indicative of beryllium-related skin disease or a sign
of exposure that could lead to sensitization. For example, dermatitis
that is unresponsive to treatment but responsive to removal from
exposure may be a sign of a beryllium-related health effect. Other skin
symptoms, such as reddened, elevated or fluid-filled lesions following
contact with soluble beryllium compounds and ulceration or granulomas
from soluble or poorly soluble beryllium compounds entering through
cuts or scrapes, can also be a sign of a beryllium-related health
effect (See Section V, Health Effects). Therefore, OSHA has revised
paragraph (k)(1)(i)(B) to include signs or symptoms of other beryllium-
related health effects.
OSHA disagrees with ORCHSE's recommendation that the final
standards apply this trigger only to employees who have been confirmed
positive, i.e., are sensitized, for several reasons. First, limiting
the sign-or-symptoms trigger in this way could prevent sensitized
employees from finding out that they are sensitized. For example, as
noted above, individuals who are genetically predisposed can develop
beryllium sensitization and CBD at beryllium levels that would not
cause disease in other individuals. Such an employee could conceivably
become sensitized and develop CBD without meeting the action level or
30-day exposure trigger. Because this hypothetical employee would not
otherwise be entitled to
medical surveillance, he or she might not know that they are
sensitized. If this employee began suffering from signs or symptoms of
CBD, he or she would not be entitled to medical surveillance under
ORCHSE's proposal, precisely because they are not entitled to the BeLPT
that would detect sensitization and then entitle them to further
medical surveillance.
Second, as discussed in more detail below, under the final
standards, employers do not automatically find out whether their
employees have been confirmed positive. If an employee chooses not to
inform his or her employer of this fact, the employer may never find
out. See paragraphs (k)(6) and (k)(7) of the final standards.
Third, OSHA recognizes that signs and symptoms associated with
adverse health effects of beryllium such as CBD and skin sensitization
may be non-specific (i.e., they may be caused by factors other than
beryllium exposure). However, it is important to realize the context in
which signs and symptoms are expected to be used in medical
surveillance. Signs and symptoms are generally expected to be self-
reported by employees who could potentially be exposed to beryllium and
as such are not intended to serve as a means for diagnosing adverse
health effects or determining their causality. Rather, they serve as a
useful signal that an employee may be suffering from a beryllium
exposure-related health effect. Once these signals are recognized, the
employee should be offered medical surveillance and see a PLHCP who
can, with sufficient information about the employee's duties, potential
exposures, and medical and work histories (as required by this standard
and discussed later), make determinations about the beryllium-related
effects, provide medical treatment, and make other referrals or
recommendations where necessary.
However, ORCHSE's comment does raise the concern that the non-
specific signs and symptoms listed in the proposal, i.e., shortness of
breath after a short walk or climbing stairs, persistent dry cough,
chest pain, or fatigue, might cause the employer to offer medical
surveillance to employees experiencing signs or symptoms that are not
related to beryllium exposure. OSHA understands that many of these non-
specific symptoms can have various causes unrelated to beryllium
exposure. For example, a dry cough could be related to a respiratory
infection or allergies. On the other hand, the symptoms listed in the
proposal can also be symptoms of CBD where they are recurring or
persistent. Therefore, OSHA has removed the specific examples of signs
or symptoms of CBD that were included in the proposal. OSHA finds that
removing these examples makes it less likely that this will be
misinterpreted to require medical surveillance for employees
experiencing signs or symptoms not related to beryllium exposure. OSHA
also clarifies that signs or symptoms that are indicative of CBD or
other beryllium-related effects are typically persistent or recurring.
Finally, OSHA emphasizes that although this provision requires
employers to offer medical surveillance if persistent or recurring
symptoms related to CBD or other beryllium-related health effects are
reported to or observed by the employer (e.g., if an employee "shows"
a persistent cough), it is not intended to force employers to survey
their workforce, make diagnoses, or determine causality. Self-reporting
by employees is supported by the training required under paragraph
(m)(4)(ii) on the health hazards of beryllium and the signs and
symptoms of CBD, and the medical surveillance and medical removal
requirements of the final standard in paragraphs (k) and (l). Section
11(c) of the OSH Act gives employees the right to report suspected
work-related health effects and prohibits employers from retaliating
against employees for exercising this right. Separately, OSHA's
Recordkeeping Rule gives employees the right to report work-related
illnesses such as CBD or other beryllium-related health effects, and
Section 1904.35(b)(1)(iv) of that rule prohibits retaliation against
employees for reporting these health effects.
Emergencies. Proposed paragraph (k)(1)(i)(C) required employers to
offer medical surveillance to employees exposed during an emergency.
Although an emergency trigger for medical surveillance was not included
in the joint draft recommended standard by Materion and USW, none of
the comments on the proposal objected to its inclusion in the final
rule (Document ID 0754). At least one commenter, NJH, supported a
trigger for employees exposed in an emergency (Document ID 1664, p. 4).
OSHA agrees with NJH that such a trigger is appropriate because
emergency situations involve uncontrolled releases of airborne
beryllium, and the significant exposures that can occur in these
situations justify a requirement for medical surveillance. Therefore,
OSHA has decided to include this provision as part of the final
standards in paragraph (k)(1)(i)(C). As in the proposal, medical
surveillance triggered by airborne exposures in emergency situations
must be offered regardless of the airborne concentrations of beryllium
to which these employees are routinely exposed in the workplace. The
requirement for medical examinations after airborne exposure in an
emergency is consistent with several other OSHA health standards,
including the standards for Chromium (VI) (29 CFR 1910.1026),
Methylenedianiline (29 CFR 1910.1050), 1,3-Butadiene (29 CFR
1910.1051), and Methylene Chloride (29 CFR 1910.1052).
Periodic medical surveillance. As noted above, OSHA asked
stakeholders to opine on which employees should be included in medical
surveillance and, as discussed in more detail below, on the appropriate
frequency for examinations (e.g., 80 FR 47574, 47541). Several
stakeholders, including Ameren Corporation (Ameren), NSSP, and ATS,
submitted pre-hearing comments supporting the provision of continuing
medical surveillance to employees who are confirmed positive (Document
ID 1675, p. 16; 1677, p. 6; 1688, p. 3). For example, ATS commented
that once an employee is sensitized, continued medical surveillance
should be offered to determine if progression to CBD occurs (Document
ID 1688, p. 3). Similarly, Ameren commented that sensitized employees
should have the opportunity for further surveillance based on the
recommendations of a pulmonologist (Document ID 1677, p. 6).
OSHA agrees that an employee who is confirmed positive should
continue to receive medical surveillance to determine if progression
from sensitization to CBD occurs and to monitor the severity of disease
if progression does occur. As discussed below, the standards provide
for medical surveillance every 2 years in certain cases, such as when
the employee continues to be exposed above the action level for more
than 30 days a year, when the employee continues to have signs or
symptoms of CBD or other beryllium-related health effects, or when an
employee is exposed to beryllium during an emergency. However, under
these first three triggers, periodic surveillance would end if an
employee no longer met those triggers. Thus, an employee who was
confirmed positive and no longer meets these triggers might not qualify
for medical surveillance again until he or she develops signs or
symptoms of disease. This gap in coverage is especially concerning
considering the potentially long lag time between sensitization and the
development of CBD and the benefits of early detection (see Section V,
Health Effects).
To allow for continued medical surveillance to this limited group
of high risk employees who would not otherwise be eligible for periodic
examinations, OSHA has added final paragraph (k)(1)(i)(D), which
requires that medical surveillance be made available when the most
recent written medical opinion to the employer recommends continued
medical surveillance. Under final paragraphs (k)(6) and (k)(7), the
written opinion must contain a recommendation for continued periodic
medical surveillance if the employee is confirmed positive or diagnosed
with CBD, and the employee provides written authorization. Under these
provisions, the employer will only receive the recommendation for
continued periodic medical surveillance with the employee's written
consent. However, even where the employee provides his or her written
consent, the written opinion must not include any specific findings or
diagnoses that led to the recommendation for continued surveillance.
Instead, the licensed physician or CBD diagnostic center's written
opinion would simply recommend continued periodic medical surveillance.
As discussed in more detail below, OSHA chose this method to convey the
need for continued medical evaluations for employees who are confirmed
positive or diagnosed with CBD, while protecting the employee's privacy
by not revealing to the employer the specific finding that triggered
the recommendation for continuing medical examinations.
OSHA notes that although this requirement was not included in
either the proposed standard or the joint draft recommended standard by
Materion and USW (Document ID 0754), proposed paragraph (k)(1)(i)(D)
(discussed below) would have allowed for limited medical surveillance
(i.e., low dose computerized tomography (LDCT)) for certain high risk
individuals.
Low dose computerized tomography (LDCT). The proposal included a
trigger to provide LDCT to some employees who met certain criteria
regarding exposure levels, exposure duration, and age. The requirement
is now included under paragraph (k)(3)(ii)(F) as a test that can be
selected by the PLHCP for employees based on certain risk factors. A
full discussion of LDCT scans and the reasons for this change is
included below under the discussion of medical examination contents.
Licensed physicians. Proposed paragraph (k)(1)(ii) required that
the employer ensure that all medical examinations and procedures
required by the standard are performed by or under the direction of a
licensed physician. OSHA chose to require licensed physicians, as
opposed to the broader category of PLHCPs, to oversee medical
surveillance in this standard, and to provide certain services required
by this standard (see, e.g., proposed paragraphs (k)(1)(ii) and
(k)(5)). OSHA has in the past allowed a PLHCP to perform all aspects of
medical surveillance, regardless of whether the PLHCP is a licensed
physician (see OSHA's standards regulating Chromium (VI) (29 CFR
1910.1026) and Respirable Crystalline Silica (29 CFR 1910.1053)). As
explained in the NPRM, OSHA proposed that a licensed physician perform
some of the requirements of paragraph (k) in response to Materion and
USW's 2012 joint draft recommended standard (80 FR 47797). OSHA
preliminarily found that this requirement struck an appropriate balance
between ensuring that a licensed physician supervises the overall care
of the employee, while giving the employer the flexibility to retain
the services of a variety of qualified licensed health care
professionals to perform certain other services required by paragraph
(k). However, the Agency specifically requested stakeholder comment on
this proposed requirement (80 FR 47575, 47797).
OSHA received comments on this subject from a variety of
stakeholders, including public health officials and representatives
from industry and labor. ATS stated that due to the complex nature of
CBD and sensitization, including multi-organ involvement and atypical
presentations, all medical procedures should be carried out by or under
the direction a licensed physician (Document ID 1688, p. 4). Similar
support for medical procedures to be carried out by or under the
direction of a licensed physician was expressed by NJH, Ameren, NSSP,
NIOSH, and ACOEM (Document ID 1664, p. 8; 1675, p. 18; 1677, p. 7;
1755, Tr. 27; 1756, Tr. 82). Materion commented that in the joint draft
recommended standard, Materion and USW intended for a licensed
physician to perform certain critical aspects of medical surveillance
such as diagnosis and preparation of the written medical opinion
(Document ID 1661, Attachment 2, p. 7). NABTU commented that medical
and nursing experts supervise medical screening of Department of Energy
workers in a program that is administered by the Center for
Construction Research and Training (CPWR) (Document ID 1679, p. 10).
OSHA recognizes that the requirement for a licensed physician to
provide oversight and some services required under the standard departs
from policy in recent standards, such as Chromium (VI) (29 CFR
1910.1026) and Respirable Crystalline Silica (29 CFR 1910.1053). In the
recently promulgated Respirable Crystalline Silica standard, OSHA
allowed medical services to be provided by a PLHCP, defined as an
individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows him or her to independently
provide or be delegated the responsibility to provide some or all of
the particular health services required under the rule (81 FR 16818).
To ensure competency while increasing flexibility for employers, OSHA
found it appropriate to allow any healthcare professional to perform
medical examinations and procedures made available under the standard
when he or she is licensed by state law to provide those services. In
the case of respirable crystalline silica, such a decision was
justified because the record did not provide convincing evidence that
such a requirement was not appropriate, and some stakeholders expressed
concerns that healthcare professionals might be limited in certain
geographical locations (81 FR 16818).
In contrast to the silica rulemaking record, the beryllium
rulemaking record shows support for a licensed physician to oversee and
perform certain functions of medical surveillance and lacks evidence
showing that licensed physicians may be limited in certain areas. As a
result, OSHA is requiring in final paragraph (k)(1)(ii) that the
employer ensure that all medical examinations and procedures required
by the standard are performed by, or under the direction of, a licensed
physician. In the case of the beryllium standard, OSHA finds this
requirement strikes an appropriate balance between ensuring that a
licensed physician supervises the overall care of the employee, while
giving the employer the flexibility to retain the services of a variety
of qualified licensed health care professionals to perform certain
other services required by paragraph (k). Therefore, final paragraph
(k)(1)(ii) requires the employer to ensure that all medical
examinations and procedures required by the standard are performed by,
or under the direction of a licensed physician.
Frequency. Proposed paragraph (k)(2) specified when and how
frequently medical examinations were to be offered to those employees
covered by the medical surveillance program. Under proposed paragraph
(k)(2)(i)(A), employers would have been required to provide each
employee with a medical examination within 30 days after
determining that the employee had worked in a regulated area for more
than 30 days in the past 12 months, unless the employee had received a
medical examination provided in accordance with this standard within
the previous 12 months. Under proposed paragraphs (k)(2)(i)(B)
employers would have been required to provide medical examinations to
employees exposed to beryllium during an emergency, and to those
showing signs or symptoms of CBD, within 30 days of the employer
becoming aware that these employees met those criteria.
As noted above, a number of stakeholders supported a baseline
examination. For example, ACOEM recommended that the criteria for
inclusion in the medical surveillance program be revised to clearly
indicate a baseline examination and BeLPT for employees assigned to
regulated areas (Document ID 1685, p. 4). Similarly, NABTU and AFL-CIO
commented that medical screening of employees should be done before
they start working in a beryllium area (Document ID 1679, p. 12; 1689,
p. 13). NJH also recommended a BeLPT at the beginning of employment but
stated that some of their clients do the exams within 30 days to not
influence hiring practices (Document ID 1664, p. 7). Ameren and NSSP
commented that 30 days from initial assignment is a reasonable period
to provide an examination; however, NSSP recommended a baseline BeLPT
at the time of employment, while Ameren indicated that a baseline BeLPT
should be at the employer's discretion based on employment history
(Document ID 1675, pp. 15-16; 1677, p. 6). These comments run contrary
to the proposed requirement allowing employers to withhold offering
medical surveillance until after more than 30 days of exposure.
OSHA is persuaded that it is appropriate to trigger medical
surveillance within 30 days after making the determinations described
in final paragraphs (k)(2)(i)(A) and (B). As a result of changes made
to final paragraph (k)(1)(i)(A), the initial exam required under final
paragraph (k)(2)(i)(A) is now triggered within 30 days after the
employer determines that the employee is or is reasonably expected to
be exposed at or above the action level for more than 30 days of year.
This revised trigger for medical surveillance in the final beryllium
standard is consistent with Ameren and NSSP recommendations to provide
an exam within 30 days of initial assignment. OSHA finds that it is a
reasonable period to offer medical surveillance because new employees
are not likely to experience signs of beryllium exposure during that
time, and it provides employers with administrative convenience because
it gives them time to make the appointment, in addition to maintaining
consistency with most OSHA standards, such as the Respirable
Crystalline Silica (29 CFR 1910.1053). In response to Ameren's comment,
OSHA acknowledges that an employee who was not previously exposed to
beryllium would not be at risk for sensitization. However, an employer
may not have a complete occupational exposure history to rule out prior
beryllium exposure of the employee, and the employee may not be aware
that he or she was exposed. OSHA considers a baseline BeLPT within 30
days of when the employer determines that the employee is reasonably
expected to be exposed for more than 30 days a year to be prudent to
rule out sensitization in an employee who may have previously been
exposed to beryllium unknowingly. Providing a baseline examination is
also consistent with the joint draft recommended standard by Materion
and USW, which recommended that medical surveillance including a BeLPT
be made available to employees who are expected to meet the trigger for
medical surveillance (Document ID 0754, pp. 7-8).
Final paragraph (k)(2)(i)(A) also differs from the proposal in that
in the proposed paragraph the employer did not have to offer an
examination if the employee had received an equivalent examination
within the last 12 months. In the final rule, this was increased to two
years to align that provision with the frequency of periodic
examinations, which is every two years in the final standards. The
reason why frequency of periodic examinations was changed from every
year to every two years is discussed below. In sum, paragraph
(k)(2)(i)(A) requires the employer to make a medical examination
available to employees who meet the criteria of paragraph (k)(1)(i)(A),
unless the employee received a medical examination provided in
accordance with the standard, within the last two years.
As noted above, proposed paragraph (k)(2)(i)(B) would have required
employers to provide medical examinations to employees exposed to
beryllium during an emergency, and to those who are showing signs or
symptoms of CBD, within 30 days of the employer becoming aware that
these employees meet the criteria of proposed paragraph (k)(1)(i)(B) or
(C), regardless of whether these employees received an exam in the
previous 2 years. OSHA is not aware of any comments from stakeholders
about the time period to offer medical examinations following a report
of symptoms or exposure in an emergency; however the 30-day requirement
to offer medical examinations to employees experiencing signs or
symptoms was included in the joint draft proposal by Materion and USW
(Document ID 0754, p. 7). Moreover, OSHA finds that the 30-day trigger
is administratively convenient for post-emergency surveillance as well
as after CBD signs or symptoms (and other beryllium-related effects
like rashes) are reported, insofar as it is consistent with other OSHA
standards and with other triggers in the beryllium standards. OSHA is
therefore retaining paragraph (k)(2)(i)(B), as proposed, in the final
rule. Proposed paragraph (k)(2)(ii) would have required employers to
provide an examination annually (after the first examination is made
available) to employees who continue to meet the criteria of proposed
paragraph (k)(1)(i)(A) or (B). The Agency requested comment on the
frequency of this medical surveillance (80 FR 47574).
Ameren agreed with the proposed frequency of annual examinations,
and USW commented that the proposed medical surveillance requirements
would allow for timely detection of sensitization and health outcomes
(Document ID 1675, p. 16; 1681, p. 13). AWE commented that it offers
annual spirometry testing to its employees with "significant
likelihood for exposure" (Document ID 1615, p. 10). DOD also provides
annual medical surveillance for its beryllium-exposed employees
(Document ID 1684, Attachment 2, p. 1-5). NIOSH commented that OSHA
should require an annual questionnaire for symptoms (Document ID 1725,
p. 32). However, other commenters argued that annual surveillance was
not routinely required. For example, NJH and ACOEM supported offering
medical examinations to eligible employees every two years (Document ID
1664, p. 4; 1685, p. 4); NJH indicated that after initial testing,
biennial medical surveillance is adequate to identify any new cases of
sensitization that may develop in the workplace. In addition, NJH,
NSSP, and NGK were opposed to annual BeLPTs (Document ID 1664, p. 4;
1677, p. 3; 1663, p. 5). ATS and NIOSH recommended examinations every 1
to 3 years for sensitized individuals to determine if progression is
occurring (Document ID 1688, p. 3; 1725, pp. 2, 32). Finally, NABTU
agreed with the proposed frequency for screening but noted that
Department of Energy
workers participating in a medical screening program administered by
CPWR are examined every three years (Document ID 1679, pp. 10-12).
After careful consideration of the record on this issue, OSHA
agrees with commenters like NJH who recommended that a BeLPT every two
years is appropriate. In addition, based on its review of beryllium
health effects, which shows that CBD generally progresses slowly (See
Section V, Health Effects), the Agency finds that a two-year frequency
period is also appropriate for the remaining parts of the medical
examinations. This two-year period is consistent with NJH's suggestion
to offer medical examinations biennially after the initial exam and
with ATS and NIOSH's recommendations for examinations every 1 to 3
years for sensitized individuals. However, OSHA disagrees with NIOSH
that a yearly questionnaire for symptoms is needed because the
standards already permit employees to receive medical surveillance by
self-reporting signs and symptoms of CBD.
To align the requirements for BeLPTs with the medical and work
history, the physical examination, and pulmonary function testing, OSHA
is requiring that all those components of the examination be offered
every two years. OSHA concludes that this approach is more convenient
for employers to administer, while maintaining adequate protection of
employees. Offering examinations every two years accomplishes the main
goals of medical surveillance for employees exposed to beryllium, which
are to detect beryllium sensitization before employees develop CBD, and
to diagnose CBD and other adverse health effects at an early stage.
Requiring examinations to be offered every two years also strikes a
reasonable balance between the resources required to provide
surveillance and the need to diagnose health effects at an early stage
to allow for interventions.
In addition, OSHA finds that it is appropriate to extend the
requirement for biennial surveillance under final paragraph (k)(2)(ii)
for employees who continue to meet the criteria of final paragraph
(k)(1)(i)(D), i.e., each employee whose most recent written medical
opinion required by paragraph (k)(6) or (k)(7) recommends periodic
medical surveillance. As discussed above, the recommendation for
continued medical surveillance is based on a confirmed positive finding
or a diagnosis of CBD. Employees such as those who are confirmed
positive benefit from periodic surveillance to determine if
sensitization progresses to CBD and monitor possible CBD progression.
Finally, OSHA revised proposed paragraph (k)(2)(ii) to specify that
medical examinations were to be made available "at least" every two
years. This change clarifies OSHA's intent that the employer need not
wait precisely two years to make medical surveillance available to
employees who continue to meet the criteria of (k)(1)(A), (B), or (D)
of this standard.
Under the final standards, employees exposed in an emergency, who
are covered by paragraph (k)(1)(i)(C), are not included in the biennial
examination requirement unless they also meet the criteria of paragraph
(k)(1)(i)(A) or (B), because OSHA expects that most effects of airborne
exposure will be detected during the medical examination provided
within 30 days of the emergency, pursuant to paragraph (k)(2)(i)(A).
This is consistent with the proposal. An exception to this is beryllium
sensitization, which OSHA finds may result from exposure in an
emergency, but may not be detected within 30 days of the emergency.
OSHA received no comments on this issue. To address possible delayed
sensitization in employees exposed in an emergency, final paragraph
(k)(3)(ii)(E) requires biennial BeLPTs for employees who have not been
confirmed positive, including those exposed in emergencies. This
paragraph is discussed in more detail later in this section of the
preamble.
Proposed paragraph (k)(2)(iii) required the employer to offer a
medical examination at the termination of employment, if the departing
employee met any of the criteria of proposed paragraphs (k)(1)(i)(A),
(B), or (C) at the time the employee's employment was terminated. This
proposed requirement was waived if the employer provided the departing
employee with an exam during the six months prior to the date of
termination. OSHA explained that the provision of an exam at
termination was intended to ensure that no employee terminates
employment while carrying a detectable, but undiagnosed, health
condition related to beryllium exposure (80 FR 47798). A similar
provision was included in the draft joint recommended standard by
Materion and USW (Document ID 0754, p. 8).
Commenters generally supported the inclusion of this provision in
the final standard. NJH and NSSP agreed with the proposed requirement
to perform a BeLPT at the time of termination and Ameren stated that a
BeLPT is not needed if the employee was tested within the last six
months (Document ID 1664, p. 7; 1675, p. 16; 1677, p. 6). However,
NABTU indicated that the BeLPT need not be repeated if the employee's
last test was done within the previous 60 days because the experience
of their medical professionals indicates that a different test result
is unlikely to occur within that time period (Document ID 1805,
Attachment 1, p. 5). After considering these comments, OSHA reaffirms
its preliminary decision to require employers to make medical
surveillance available at the time of termination to eligible
employers. Final paragraph (k)(2)(iii) requires the employer to make a
medical examination available to each employee who meets the criteria
of final paragraph (k)(1)(i)--the action level/30-day-exposure based
trigger, shows signs or symptoms of CBD, or is exposed during an
emergency--at the termination of employment, unless the employee
received an exam meeting the requirements of the standards within the
last 6 months. OSHA also finds that it is appropriate to extend the
requirement to employees who meet the criteria of final paragraph
(k)(1)(i)(D), i.e., each employee whose most recent written medical
opinion required by paragraph (k)(6) or (k)(7) recommends periodic
medical surveillance. Like the other employees covered by this
provision, those employees could potentially have beryllium-related
disease that was not present or detectable at their last examination or
that has advanced.
As indicated in the proposal, OSHA finds that providing a BeLPT at
the time of termination, unless the employee was tested within the last
six months or the employee was confirmed positive, is important to
ensure that no employee is unknowingly sensitized at the time he or she
leaves the job. In addition, OSHA finds that the other components of
the examination, such as a medical and work history, the physical
examination, and lung function testing are also important to determine
if an employee may have developed physical signs of disease or if
existing disease may have progressed since the last examination. OSHA
disagrees with NABTU that another BeLPT should be conducted if the
employee's last BeLPT was done more than two months ago. Requiring
another BeLPT if the employee has not had one within the past six
months is an abundantly cautious approach considering that public
health officials, such as NJH, recommend a BeLPT every two years, since
that time period is considered adequate to identify any new cases of
sensitization that may develop in the workplace (Document ID 1664, p.
4). Therefore, OSHA concludes that
offering a BeLPT at termination, if the employee has not had one in the
past six months, is an approach that adequately protects the employee's
health.
Contents of Examination. Proposed paragraph (k)(3) detailed the
contents of the examination. Proposed paragraph (k)(3)(i) required the
employer to ensure that the PLHCP advised the employee of the risks and
benefits of participating in the medical surveillance program and the
employee's right to opt out of any or all parts of the medical
examination. As OSHA explained in the proposal, the benefits of
participating in medical surveillance may include early detection of
adverse health effects, and aiding intervention efforts to prevent or
treat disease. However, there may also be risks associated with medical
testing for some conditions, such as radiation risks from CT scans for
lung cancer (80 FR 47798). The employer must make sure the PLHCP
communicates those risks to the employee. This requirement was included
in the draft proposed rule submitted to the Agency by Materion and USW
(Document ID 0754, p. 8). In the absence of public comments on this
issue, the requirement remains substantively unchanged from the
proposal in final paragraph (k)(3)(i). OSHA did, however, make one
minor change to clarify the intent of this provision. Under the final
standards, the PLHCP who advises the employee must be the PLCHP who is
conducting the examination. Proposed paragraphs (k)(3)(ii)(A)-(D)
specified that the medical examination must consist of: A medical and
work history, with emphasis on past and present exposure, smoking
history, and any history of respiratory dysfunction; a physical
examination with emphasis on the respiratory system; a physical
examination for skin breaks and wounds; and a pulmonary function test,
performed in accordance with guidelines established by the American
Thoracic Society including forced vital capacity (FVC) and a forced
expiratory volume in one second (FEV1). Exam contents under
the proposal also included a standardized BeLPT and, in some cases, a
computerized tomography (CT) scan, both of which are discussed in more
detail below. OSHA asked for comment on the contents of the medical
surveillance exam in the proposal (80 FR 47574). Among other things,
the Agency asked whether the required tests were appropriate, if
additional tests should be included, and whether the skin should be
examined for signs and symptoms of beryllium exposure or other medical
issues, as well as for breaks and wounds. Stakeholders from the medical
community and industry responded to OSHA's request for comment on the
proposed contents for medical examinations. Ameren, NSSP, and NABTU
agreed with the tests that OSHA proposed, including skin examinations
(Document ID 1675, p. 16; 1677, p. 6; 1679, p. 12). ORCHESE was opposed
to examining the skin for wounds and breaks because although skin
injuries could allow for increased beryllium absorption, they are
temporary conditions that could heal within days, thus making the
finding observed during the exam irrelevant (Document ID 1691,
Attachment 1, p. 7). NIOSH and ATS supported medical and work histories
or questionnaires, but neither they nor NJH supported routine physical
examinations and lung function testing of beryllium exposed employees
(Document ID 1664, p. 8; 1688 p. 3; 1725, p. 32). ATS and NIOSH
commented that physical examinations and lung function testing are not
effective for identifying sensitization or CBD. NJH recommended that
physical examinations and pulmonary function tests be offered to
employees who do not have CBD but are experiencing symptoms, while
NIOSH said that required tests should be determined by the PLHCP, based
on responses to the questionnaire. Lung function (spirometry) testing
is the only type of examination that AWE routinely does on its
employees with "significant likelihood for exposure" (Document ID
1615, p. 10). DOD includes a history, physical exam, a chest X-ray, and
spirometry in its surveillance program, and agreed that the skin should
be examined (Document ID 1684, Attachment 2, p. 1-5). 3M agreed that an
employee's fitness to wear a respirator should be evaluated, but they
argued that incorporating requirements of the medical evaluation under
the respiratory protection program (29 CFR 1910.134(e)) would be a
better tool for evaluating fitness to wear a respirator than the
proposed medical surveillance requirements. In support of this
statement, it asserted that pulmonary function tests are a poor
predictor for fitness to wear a respirator (Document ID 1625, pp. 3-5).
OSHA recognizes, as ATS, NIOSH, and NJH commented, that physical
examinations and lung function testing are not effective for detecting
sensitization or CBD. However, OSHA still finds that these tests should
be included as part of medical surveillance examinations of beryllium
exposed workers because they accomplish important goals of medical
surveillance as part of an occupational health program. As indicated
above, the major purposes of medical surveillance for beryllium-exposed
employees go beyond identifying disease and include identifying
conditions that put employees at increased risk from beryllium exposure
and determining the employee's fitness to use personal protective
equipment such as respirators. The medical examination for beryllium
complements the medical evaluation under the respiratory protection
program that must still be conducted before an employee is fitted for a
respirator or uses the respirator in the workplace (29 CFR
1910.134(e)(1)). Physical examinations and lung function tests are
objective measures that are valuable in accomplishing the goals of
medical surveillance for beryllium and to determine fitness to use
personal protective equipment. For example, listening to heart and lung
sounds with a stethoscope and conducting lung function testing might
identify an impairment in an employee who is not experiencing symptoms
but might be at risk with use of a negative pressure respirator. Such
impairments in employees lacking symptoms may not be identified in the
medical evaluation for respirator use, which typically involves
administering a questionnaire and may not involve an examination.
Another example of how the required tests under the beryllium standard
accomplish goals of medical surveillance is that an employee who is
found to have a loss in lung function can be warned that lung function
loss can be compounded if that employee develops CBD.
Skin examinations are also important because skin rashes could be a
sign of dermal sensitization or also a sign that exposures that put the
employee at risk of becoming sensitized have occurred. However, OSHA
agrees with ORCHESE that conditions such as breaks and wounds are
temporary and has therefore revised the proposed paragraph so that
final paragraph (k)(3)(ii)(C) requires a physical examination for skin
rashes, rather than an examination for breaks and wounds. OSHA notes
that PLHCPs will nonetheless detect skin injuries during the skin
examination, and when doing so can take that as an opportunity to
educate the employee on the importance of using protective clothing,
because beryllium absorption can be increased through broken skin.
OSHA also revised proposed paragraph (k)(3)(ii)(A), which would
have required, among other things, "a medical and work history, with
emphasis on past and present exposure" so that final paragraph
(k)(3)(ii)(A)
includes emphasis on past and present airborne exposure to or dermal
contact with beryllium. OSHA added dermal contact to this list because,
as noted by NJH and ACOEM, dermal contact can result in skin effects
and sensitization (Document ID 1664, p. 5, 1685, p. 3). As discussed in
Section V, Health Effects, dermal contact with beryllium can lead to
respiratory and dermal sensitization and it is therefore an appropriate
factor to consider as part of the medical and work history. With these
changes, final paragraphs (k)(3)(ii)(A)-(D) require the medical
examination to include: (1) Medical and work history, with emphasis on
past and present airborne exposure to or dermal contact with beryllium,
smoking history, and any history of respiratory dysfunction; (2) a
physical examination with emphasis on the respiratory system; (3) a
physical examination for skin rashes; and (4) a pulmonary function
test, performed in accordance with guidelines established by the ATS
including forced vital capacity (FVC) and a forced expiratory volume in
one second (FEV1).
Under proposed paragraph (k)(3)(ii)(E), an employee would have been
offered a BeLPT or an equivalent test at the first examination, and
then at least every two years after the first examination, unless the
employee was confirmed positive. As OSHA explained in the preamble to
the proposal, the proposed requirement to test for beryllium
sensitization was intended to apply whether or not an employee was
otherwise entitled to a medical examination in a given year (80 FR
47799). For example, for an employee exposed during an emergency who
would have normally been entitled to 1 exam within 30 days of the
emergency but not annual exams thereafter, the employer would still
have been required to provide this employee with a test for beryllium
sensitization every 2 years. OSHA further explained that this proposed
biennial requirement would have applied until the employee was
confirmed positive. The Agency preliminarily found that the biennial
testing required under proposed paragraph (k)(3)(ii)(E) was adequate to
monitor employees at risk of developing sensitization while being
sufficiently affordable for employers.
The record showed strong support for use of BeLPT, with limited
exceptions. NIOSH supported the BeLPT to identify sensitized employees,
citing recent evidence that the BeLPT has a sensitivity of 66 to 86%
and a specificity of >99%, which it stated is superior or comparable to
other common medical screening test (Document ID 1725, pp. 32-33). In
responding to comparisons of the BeLPT against World Health
Organization (WHO) (Wilson) criteria (see next paragraph), NIOSH
concluded that current evidence supports the use of the BeLPT to
benefit both the individual employee and to identify improvements that
could be made in work areas to prevent other workers from becoming
sensitized (Document ID 1725, p. 33). BeLPT is also supported by or
used in medical screening by medical authorities, unions, and industry
stakeholders including Materion, NJH, Ameren, NSSP, USW, ACOEM, ATS,
and ORCHSE (Document ID 1661, Attachment 2, pp. 7-8; 1664, p. 4; 1675,
p. 16; 1677, pp. 5-6; 1681, p. 25; 1685, p. 4; 1688, p. 3; 1691,
Attachment 1, p. 12). Ameren also commented that a BeLPT should be
provided for employees diagnosed with sarcoidosis because of the
potential for a misdiagnosis of CBD (Document ID 1675, p. 16). USW
supported periodic BeLPTs because workers with a history of exposure
remain at risk in the future (Document ID 1681, pp. 13-14). NJH
supported biennial BeLPTs, which is consistent with the draft joint
recommended standard by Materion and USW (Document ID 0754; 1664, p.
4).
In contrast, based on a false positive rate reported in a review
done by AWE in 1990, AWE commented that it does not routinely use BeLPT
in its medical surveillance program (Document ID 1615, p. 11). DOD did
not support the BeLPT, arguing that it has not been shown to meet WHO
guidelines as a screening tool (often referred to as the Wilson
Criteria, which evaluates factors such as reliability of the assay and
its usefulness to identify disease at an early stage in which treatment
would be beneficial) (Document ID 1958, p. 8).
After carefully considering these comments, OSHA agrees with NIOSH
that the BeLPT is appropriate based on its sensitivity and low false
positive rate that is comparable or superior to other screening tests.
Unlike DOD, OSHA finds that the BeLPT does meet a number of the Wilson
criteria because it is an acceptable, reliable test that allows for a
serious disease to be diagnosed at an early stage, when employees with
symptoms could benefit from treatment, or in the case of occupational
exposures, interventions such as removal from exposure. OSHA agrees
with Ameren that a BeLPT is an important component for diagnosing lung
disease in beryllium-exposed employees to prevent a misdiagnosis. And
OSHA reaffirms that it is important to conduct the BeLPT at least every
two years to screen for beryllium sensitization, until the employee is
confirmed positive. As in the proposal, the biennial requirement to
test for beryllium sensitization applies regardless of whether an
employee is otherwise entitled to a medical examination in a given
year. OSHA concludes that this continuing requirement is important
because sensitization can occur after exposures end.
OSHA finds that in general, the biennial testing required under
paragraph (k)(3)(ii)(E) is adequate to monitor employees that have the
potential to develop sensitization while being sufficiently affordable
for employers. However, one change to this provision compared to the
proposed standard is to allow the test to be offered "at least" every
two years, rather than every two years as proposed. This change
clarifies OSHA's intent that the employer need not wait precisely two
years to make the BeLPT available to employees.
Final paragraph (3)(ii)(E) contains a number of other differences
compared to the proposed requirements. Consistent with the definition
in the proposed standards, the proposed paragraph considered two
abnormal test results necessary to confirm a finding of beryllium
sensitization when using the BeLPT ("confirmed positive"). Therefore,
the proposal would have required that the BeLPT be repeated within one
month of an employee receiving a single abnormal result. As discussed
in more detail in the Summary and Explanation for paragraph (b),
Definitions, commenters including ACOEM and ATS indicated that
retesting should also be done following borderline BeLPT results, and
as ACOEM noted, one borderline and one positive test or three
borderline tests have a high predictive value for sensitization
(Document ID 1685, p. 4; 1688, p. 2). In response to such comments,
OSHA changed the definition of confirmed positive to two abnormal test
results, an abnormal test result and a borderline test result, or three
borderline test results. Therefore, to make this paragraph consistent
with the revised definition, the text was changed to indicate that a
follow-up BeLPT must be offered within 30 days for results that are
"other than normal" unless the employee has been confirmed positive.
This language makes it clear that not only abnormal BeLPT results, but
also borderline BeLPT results must be followed up according to the
definition for confirmed positive. When an other than normal result is
obtained, testing is to be repeated within 30 days, unless the employee
is confirmed positive. This means that follow-up can stop as soon as it
is determined that the
employee is confirmed positive (e.g., after receiving an abnormal and
borderline test or three borderline tests).
The proposed paragraph indicated that the requirement for a repeat
BeLPT was waived if a more reliable and accurate test were to become
available that could confirm beryllium sensitization based on one test
result. OSHA requested comments on the availability of more reliable
and accurate tests than the BeLPT for identifying beryllium
sensitization (80 FR 47575). ORCHSE took issue with the statement that
retesting would not be required if a more reliable and accurate test
became available that could confirm beryllium sensitization based on
one test result. It interpreted the statement to mean that an employee
who tested positive would not receive a second BeLPT or second test
that is more reliable and accurate than the BeLPT, leaving the employee
with only one abnormal test that was unconfirmed (Document ID 1691;
Attachment 1, pp. 7-8).
To streamline the paragraph and avoid misunderstandings of the
Agency's intent, OSHA removed the language waiving a second
confirmatory test if a more accurate and reliable test became available
that did not require retesting for confirmation of sensitization.
Instead, final paragraph (k)(3)(E) requires a standardized BeLPT or
equivalent test, upon the first examination and at least every two
years thereafter, unless the employee is confirmed positive. If the
results of the BeLPT are other than normal, a follow-up BeLPT must be
offered within 30 days, unless the employee has been confirmed
positive. This revision clarifies that only other than normal BeLPT
results must be followed up within 30 days. Because the paragraph
refers to follow-up testing for other than normal "BeLPT" results,
the requirement would not apply to a more accurate and reliable test
that would not require an abnormal result to be confirmed.
OSHA acknowledges that the "more accurate and reliable"
alternative remains hypothetical as there are currently no tests for
beryllium sensitization that allow for a confirmed diagnosis of
sensitization based on one test. However, if developed and validated as
described below, such a test would be an improvement because it would
eliminate the need for an employee to go back to have blood drawn a
second and possible third time. OSHA's intent was to allow the current
BeLPT requirement to be replaced with a more accurate and reliable test
that would not require retesting to confirm sensitization, if such a
test were ever developed. To clarify the Agency's intent, final
paragraph (k)(3)(ii)(E) now specifies that a standardized BeLPT "or
equivalent test" is to be offered. OSHA considers an "equivalent
test" to be a test that would accurately identify sensitization based
on one test result. Thus, the original intent of that requirement is
unchanged, but OSHA clarifies that an "equivalent test" could also be
a validated test that is superior to the BeLPT for other reasons. For
example, NJH commented that alternative tests to the BeLPT are being
developed that could require less blood and less sample manipulation
and provide earlier results (Document ID 1664, p. 9).
NJH commented on validating tests for beryllium sensitization that
might be superior to a BeLPT (Document ID 1664, p. 9). It noted that
validation could occur in a College of American Pathologists (CAP)/
Clinical Laboratory Improvement Amendments (CLIA) laboratory. Once the
assay is determined to be robust and reproducible, clinical validation
should then be performed using samples from patients known to be
sensitized and from unexposed controls. OSHA agrees and as explained in
the Summary and Explanation for paragraph (b), Definitions, before any
test could be considered "equivalent" to a BeLPT for identifying
sensitization but based on a single test result, the test must undergo
rigorous validation to ensure that it has comparable or increased
sensitivity, specificity, and positive predictive value within one test
result than the BeLPT. OSHA also recommends that before any test for
sensitization is considered equivalent to a BeLPT, it should be widely
accepted by authoritative sources, such as CDC/NIOSH, ACOEM, and ATS,
based on the validation criteria described above. Such an approach is
conceptually consistent with that in the draft recommended standard by
Materion and USW that required the CDC to approve a more reliable test
that could eliminate the need to confirm a positive finding. The joint
draft recommended standard by Materion and USW required that the BeLPT
be performed in a laboratory licensed by the CDC (Document ID 0754). In
contrast, OSHA's proposed provision did not require that a BeLPT be
conducted by a laboratory that was licensed or accredited. OSHA
requested comment on whether testing should be performed by a
laboratory accredited by an organization such as CLIA (80 FR 47575).
Commenters including NJH, Ameren, NSSP, Materion and USW, ACOEM,
and ORCHSE supported the inclusion of a requirement that laboratories
performing BeLPT be accredited by CAP and/or CLIA (Document ID 1664,
pp. 8, 9; 1675, p. 19; 1677, p. 7; 1680, p. 7; 1685, p. 5; 1691,
Attachment 1, p. 13). For example, NJH commented that a CAP/CLIA
certification represents the standard for oversight for clinical
testing to ensure proper quality control and testing (Document ID 1664,
p. 9). ACOEM further added that those laboratories should undergo
periodic proficiency testing (Document ID 1685, p. 5). Materion and USW
also recommended that all laboratories that conduct BeLPT have a
standard procedure and algorithm and that their BeLPT be approved by
the FDA, but that these issues should not delay promulgation of the
rule (Document ID 1680, p. 7). However, NJH indicated that while it
would be preferable, standardization of interpretation algorithms
across laboratories is challenging because it is influenced by many
variables such as serum and reagent lots, sample quality, use of round
versus flat bottomed plates, and technician skill (Document ID 1664, p.
8). NSSP commented that all current BeLPT laboratories have
certifications from CAP and/or another accreditation organization
approved under CLIA and have participated in inter-laboratory split
specimen testing (Document ID 1677, p. 7).
After reviewing these comments and the remainder of the record on
this issue, OSHA is convinced that requiring that the BeLPT be
conducted by CAP/CLIA-certified laboratories would improve quality of
BeLPT results. Based on comments from NSSP, all laboratories conducting
BeLPTs are currently accredited. OSHA therefore finds that accredited
laboratories are currently available and including such a requirement
in the standards would not delay promulgation of the rule. The Agency
also finds that CAP/CLIA certification helps improve proficiency in
terms of obtaining accurate results that are appropriately interpreted
and ensures that quality control procedures are followed. Therefore, to
improve the accuracy and reliability of BeLPTs, the standards require
that samples be analyzed by a laboratory certified under CAP/CLIA
guidelines to perform the BeLPT.
As a result of the changes discussed above, final paragraph
(k)(3)(E) specifies that the examination must include a standardized
BeLPT or equivalent test, upon the first examination and at least every
two years thereafter, unless the employee is confirmed positive. If the
results of the BeLPT are other than normal, a follow-up BeLPT must be
offered within 30 days, unless the employee has been confirmed
positive. Samples must be analyzed by a laboratory certified under the
College of American Pathologists (CAP)/Clinical Laboratory Improvement
Amendments (CLIA) guidelines to perform the BeLPT.
Proposed paragraph (k)(3)(ii)(F) would have required a CT scan to
be offered to employees who had been exposed to beryllium at
concentrations above 0.2 μg/m3\ for more than 30 days in a 12-month
period for 5 years or more. As OSHA explained in the preamble, the five
years of exposure did not need to be consecutive (80 FR 47799). As with
the requirement for sensitization testing explained above, the CT scan
would have been required to be offered to an employee who met the
criteria of paragraph (k)(1)(i)(D) without regard to whether the
employee was otherwise required to receive a medical exam in a given
year. OSHA explained that the CT scan would have been offered to
employees who met the criteria of paragraph (k)(1)(i)(D) for the first
time beginning on the start-up date of this standard, or 15 years after
the employee's first exposure to beryllium above 0.2 μg/m3\ for
more than 30 days in a 12-month period, whichever was later. OSHA
proposed the requirement for CT screening based in part on the Agency's
consideration of the draft recommended standard submitted by industry
and union stakeholders (Document ID 0754, p. 8).
OSHA requested comment on the proposed CT scan requirements, as
part of the content of the medical examinations (80 FR 47574). In
addition, OSHA asked stakeholders to opine on two regulatory
alternatives related to CT scans: (1) Regulatory Alternative #18, which
would have dropped the CT scan requirement from the proposed rule, and
(2) Regulatory Alternative #19, which would have increased the
frequency of periodic CT scans from biennial to annual scans (80 FR
47571).
A number of stakeholders responded to the Agency's request for
comments on the proposed CT scan requirements. Two such commenters,
Public Citizen and NJH, referenced criteria for low-dose CT lung cancer
screening set forth by the U.S. Preventive Services Task Force
(USPSTF), an independent, volunteer panel of national experts in
prevention and evidence-based medicine (Document ID 1664, p. 4; 1964,
p. 4). In December, 2013, the USPSTF recommended annual screening for
lung cancer with LDCT for adults aged 55 to 80 years with a 30-pack-
year smoking history and who either currently smoke or have quit within
the past 15 years. Under USPSTF's criteria, screening should be
discontinued once a person has not smoked for 15 years or develops a
health problem that substantially limits life expectancy or the ability
or willingness to have curative lung surgery (Moyer et al., 2014,
Document ID 1791). The USPSTF recommendation was based on the findings
of the National Lung Cancer Screening Trial (NLST), which was a large
study of the effectiveness of using x-ray and LDCT screening for early
detection of lung cancer.
The NLST enrolled asymptomatic men and women (n = 53,454), aged 55
to 74, that were current smokers or former smokers within the last 15
years and had a smoking history of at least 30 pack-years. The
participants underwent annual lung cancer screening with either LDCT or
chest radiography for three years. The results showed a statistically
significant 20-percent relative reduction in lung cancer mortality with
LDCT screening (Aberle, et al., 2011, Document ID 1701). However, the
trial also showed that LDCT screening results in a high false-positive
rate; 24.2 percent of the total LDCT screening tests were classified as
positive, with 96.4 percent of these positive results ultimately being
false positives. In addition, 39.1 percent of the 26,722 (or about
10,450) participants in the LDCT screening group had at least one
positive screening result out of three LDCT scans during the study
(Alberle, et al., 2011, Document ID 1701). Given that only 649 cancers
were diagnosed after a positive screening test, and assuming that each
of these cancers was in a different participant, it follows that only
6.2 percent of those with at least one positive test were ultimately
diagnosed with lung cancer. This means that 36.7 percent of
participants in the LDCT screening group had at least one false
positive result. Most positive initial screening results in the NLST--
many of which were false positives--were followed up with a diagnostic
evaluation that included further imaging and, infrequently, invasive
procedures (Alberle, et al., 2011, Document ID 1701).
Given these findings, the USPSTF noted, in its recommendation for
lung cancer screening for high-risk individuals, the importance of
shared decision making. The USPSTF advised:
Shared decision making is important for the population for whom
screening is recommended. The benefit of screening varies with risk
because persons who are at higher risk because of smoking history or
other risk factors are more likely to benefit. Screening cannot
prevent most lung cancer deaths, and smoking cessation remains
essential. Lung cancer screening has substantial harms, most notably
the risk for false-positive results and incidental findings that
lead to a cascade of testing and treatment that may result in more
harms, including the anxiety of living with a lesion that may be
cancer. Overdiagnosis of lung cancer and the risks of radiation are
real harms, although their magnitude is uncertain. The decision to
begin screening should be the result of a thorough discussion of the
possible benefits, limitations, and known and uncertain harms
(Moyer, et al., 2014, Document ID 1791, p. 333).
In addition to the USPSTF, several other organizations have
recommended similar lung cancer screening protocols for high-risk
individuals, including the American Cancer Society, American College of
Chest Physicians, American Society of Clinical Oncology, American Lung
Association, National Comprehensive Cancer Network, and the American
Association for Thoracic Surgery. Each organization's specific
screening recommendations are summarized by the U.S. Centers for
Disease Control and Prevention: http://www.cdc.gov/cancer/lung/pdf/guidelines.pdf.
With regard to occupational exposure, OSHA is not aware of any
definitive recommendations based on a large, well-conducted,
randomized, controlled study examining the benefit of lung cancer
screening with LDCT among occupationally-exposed workers. In its pre-
hearing comments, NIOSH noted that the screened population must be at
sufficiently high risk for lung cancer in order to assure that the
benefit of LDCT screening for early detection exceeds the harm
(Document ID 1671, Attachment 1, p. 8). NIOSH cited a report by the
Finnish Institute of Occupational Health (FIOH) that recommended LDCT
screening in asbestos-exposed individuals if their personal combination
of risk factors, particularly smoking history, yields a risk for lung
cancer equal to that needed for entry into the NLST. NIOSH noted that
the absolute risk for lung cancer in the NLST and the threshold
absolute risk for lung cancer proposed by FIOH as a trigger for LDCT
screening was 1.34% over 6 years (Document ID 1671, Attachment 1, p.
8).
OSHA also received comments in the record pointing to the LDCT lung
cancer screening recommendations of the National Comprehensive Cancer
Network (NCCN), a nonprofit alliance of 27 cancer centers (Document ID
1805, Attachment 1; Document ID 1959). In addition to recommending
screening for individuals (current smokers or former smokers that have
quit within the last 15 years) who are 55 to 74 years of age
with a smoking history of at least 30 pack-years, the NCCN recommended
LDCT screening for individuals age 50 years or older with a smoking
history of at least 20 pack-years and with one or more additional risk
factors; these risk factors include a history of COPD or pulmonary
fibrosis, a history of cancer, a family history of lung cancer, radon
exposure, or occupational exposure to the carcinogens asbestos,
arsenic, beryllium, cadmium, chromium, nickel, silica, or diesel fumes
(Document ID 1815, Attachment 39). Like the USPSTF, NCCN noted that
individuals who qualify under these LDCT screening recommendations
should engage in shared decision making with their physician and
discuss the benefits and harms of LDCT screening for lung cancer
(Document ID 1815, Attachment 39).
Thus, the studies and recommendations discussed above indicate that
age and smoking history are crucial risk factors that determine when
the benefits of LDCT screening are likely to outweigh the risks from
radiation exposure and false-positive results. The radiation exposure
received from periodic LDCT scans increases the risk of lung and breast
cancer, as well as leukemia. Public Citizen estimated the risk of these
cancers that could result when workers are screened as described in
OSHA's proposed rule (Document ID 1964, pp. 4-6). Public Citizen also
estimated the total radiation dose received to range from 900 to 2,400
mrems, depending on age at which screening begins. The excess cancer
risks resulting from these exposures, based on Public Citizen's use of
the National Academies BIER VII report, ranged from 3.7 to 29.9 deaths
per 1,000 workers for solid organ cancers, and from 0.5 to 2.3 deaths
per 1,000 for leukemia (Document ID 1964, p. 6). These risk estimates
are comparable to OSHA's estimated lung cancer mortality risk resulting
from exposure to beryllium at the PEL of 0.2 μg/m3\ over a working
life (see Section VI, Risk Assessment). False-positive results carry
the risk of additional radiation exposure from repeat scans, as well as
unnecessary anxiety for the workers and his or her family, unnecessary
invasive procedures that may have risks of medical complications, and
unnecessary medical expenses (Document ID 1806, pp. 1-2; 1964, pp. 7-
8).
A number of rulemaking participants agreed that the lung cancer
risks from beryllium exposure are, for the vast majority of workers,
unlikely to be so high that LDCT screening would be beneficial,
including NJH, ATS, ORCHSE, NIOSH, Public Citizen, NGK, and the
Aluminum Association (Document ID 1664, pp. 1, 4; 1688, p. 2; 1691,
Attachment 1, p. 1; 1671, Attachment 1, pp. 8-9; 1964, p. 4; 1663, p.
3; 1666, pp. 3-4). For example, NJH commented that the risk of lung
cancer associated with exposure to beryllium at the final rule's PEL of
0.2 μg/m3\ was likely to be lower than that from the radiation
exposure received from LDCT screening, particularly for workers under
age 50 (Document ID 1664, p. 4). NJH also stated that the majority of
beryllium-exposed workers are former smokers and many would not fit the
criteria for the USPSTF recommendations (Document ID 1664, p. 4).
ORCHSE argued that "[e]xtrapolation of the results of the non-
occupational National Lung Screening Trial for implementation in the
occupational setting is premature, and fraught with a number of
potential issues and concerns [e.g., over-diagnosis, false positives,
radiation dose, follow-on invasive procedures and attendant
complications]. The requisite 30 pack-year trigger recommended for
screening is associated with risks orders of magnitude higher than that
associated with beryllium exposure" (Document ID 1691, Attachment 1,
p. 1). Similarly, in post-hearing comment, Public Citizen remarked that
it would be a "dangerous mistake" to provide LDCT screening for the
majority of non-smoking beryllium-exposed workers who are at low risk
for lung cancer and thus would not benefit from such screening
(Document ID 1964, p. 10).
The suggestion that beryllium exposure alone would lead to lung
cancer risks too low to warrant LDCT screening was illustrated by NIOSH
in an analysis of risk information. NIOSH used the mortality study by
Schubauer-Berigan et al. (2011 b, Document ID 0521) to estimate the
exposure levels to beryllium that would result in a risk level at least
as high as that suggested by FIOH as a trigger for LDCT screening
(i.e., an absolute increased risk of 1.34 percent over a 6-year
period). To reach risk levels of this magnitude, NIOSH found that a 40-
year-old would have had to have been exposed to a mean daily weighted
average exposure of 12 μg/m3\ to achieve a lung cancer risk level
sufficient to justify LDCT, and a 50-year-old worker would have had to
have been exposed to a mean daily weighted average exposure of 2 μg/
m3\, a daily exposure equal to the previous PEL. It was not possible
for NIOSH to estimate the required level of beryllium exposure
necessary above age 60 to reach a risk level equal to that suggested by
FIOH because the background rate of lung cancer already exceeded that
level. Although there are uncertainties around the NIOSH estimates (for
example, use of 10-year rather than 6-year age intervals, which would
understate the required level of beryllium exposure), OSHA finds that
the NIOSH analysis demonstrates that LDCT screening would benefit non-
smoking workers exposed to beryllium only where the workers were
exposed to very high concentrations of beryllium, i.e., levels at and
above the previous PEL.
Many of the rulemaking commenters who objected to the proposed
requirement for LDCT screening also believed that the absence of any
studies showing the effectiveness of LDCT screening on beryllium-
exposed workers was further reason not to require LDCT screening based
only on a history of beryllium exposure (Document ID 1664, p. 1; 1688,
p. 2; 1691, Attachment 1, p. 1; 1756, pp. 123-125; 1806, pp. 1-2). For
example, Dr. Newman, who represented ACOEM at the public hearing, in
response to a question testified that
. . . we don't have any data on beryllium--specifically looking at
beryllium workers with the cluster of risk factors [i.e., smoking
plus Be exposure] that you've described. And I think that absent
that it means that there is more of a question mark around . . . how
far should OSHA go at this point with low dose CT (Document ID 1756,
pp. 124-125).
In contrast to these commenters, inclusion of LDCT screening into the
final rule was supported by USW in written comments and at the informal
public hearing. Sara Brooks of the USW commented that
The proposed inclusion of a low dose CT scan as part of medical
surveillance is entirely justified. The low dose CT scan can
effectively detect lung cancer at an early stage and has been
demonstrated to reduce lung cancer mortality among high risk
individuals. Since lung cancer is recognized as an outcome caused by
beryllium exposure, inclusion of the low dose CT scan in the
proposed rule is appropriate (Document ID 1681, Attachment 1, p.
14).
Dr. Steven Markowitz of the City University of New York, testifying on
behalf of USW, supported OSHA requiring LDCT screening for beryllium-
exposed workers, citing the NLST finding that screening reduced lung
cancer mortality by 20 percent. He also noted that
[t]he use of LDCT is rapidly increasing because of just how common
lung cancer is. And this is an effective non-invasive technique. And
that there can really [be] a display of leadership by including LDCT
now in the proposed medical standard for beryllium (Document ID
1755, Tr. 110).
In post-hearing comment, Dr. Markowitz suggested limiting the
proposal's requirement to apply to workers age 50 or more, and pointed
out that this was consistent with OSHA's past practice (i.e., medical
surveillance requirements under the Cadmium standard, 29 CFR 1910.1027)
and with NCCN recommendations (Document ID 1959, p. 1). Second, he
argued that the assertion that LDCT should not be included in the rule
based on the lack of studies showing efficacy of LDCT on beryllium-
exposures workers was "without merit" (Document ID 1959, p. 1). He
pointed out that many of the risk factors used by the medical community
as a basis for recommending LDCT (e.g., family medical history,
presence of chronic obstructive lung disease) lack empirical evidence
relating the effectiveness of LDCT to the presence of these risk
factors. Thus, Dr. Markowitz argued that "[t]he decision to undergo
(by the individual) or to recommend (by the physician) LDCT for lung
cancer screening is based on that individual's overall level of risk of
lung cancer, not on the particular mix and magnitude of individual risk
factors that constitute overall risk" (Document ID 1959, p. 1). He
also argued that because cancers caused by beryllium exposure are
similar to the types of lung cancers from other causes, beryllium
exposure is not more or less amenable to LDCT screening than are
smoking history or other risk factors (Document ID 1959, p. 2). Dr.
Markowitz concluded that the absence of studies on beryllium-exposed
workers and LDCT screening "should not be a decisive factor in
determining whether LDCT should be included in the final OSHA standard
on beryllium." (Document ID 1959, p. 3).
OSHA agrees in general that beryllium exposure should be considered
as a risk factor when deciding whether LDCT screening is appropriate,
and agrees that it is not appropriate to wait for specific studies to
be conducted before considering that a history of beryllium exposure
should be factored into a decision to undergo LDCT screening. This is,
in fact, consistent with the NCCN's criteria for LDCT screening that
include occupational exposures along with age, smoking history, and
other risk factors. However, LDCT screening is not triggered under
these criteria based on occupational exposures and age alone; there
must also be a history of smoking (albeit a lower trigger than when
considering only age and smoking). As discussed above, there is no
evidence in the record that exposure to beryllium alone at the level
used in the proposal to trigger LDCT screening results in a cancer risk
sufficiently high to warrant LDCT screening.
For the final rule, OSHA considered increasing the threshold of
beryllium exposure such that LDCT screening would be triggered at much
higher exposures to beryllium (e.g., average exposure above 2 µg/
m3\ for over several years), as was suggested by the NIOSH analysis.
OSHA rejected this approach for three reasons. First, as pointed out by
ORCHSE (Document ID 1691, Attachment 1, p. 6), it is unlikely that
exposure records would be available for many workers to show that the
trigger was met, except where workers had long employment tenure with
their present employer. Second, establishing such a high exposure
trigger for LDCT screening would, in fact, exclude workers with a
history of lesser beryllium exposure even when other risk factors are
present such that LDCT would be beneficial. Finally, OSHA is reluctant
to fix a hard exposure trigger in the standard given that, as pointed
out by USW, LDCT technology is likely to advance and increase the
efficacy of screening to where screening becomes beneficial for those
with lesser risk of lung cancer than is reflected by current
recommendations.
Therefore, OSHA concludes that the best approach is to require LDCT
screening for beryllium-exposed workers based on the recommendation of
the physician conducting or overseeing the medical examination, after
all relevant risk factors have been considered, and has accordingly
reflected this approach in the final standards. For these reasons,
paragraph (k)(3)(ii)(F) of the final standards requires the medical
examination to include an LDCT scan, when recommended by the PLHCP
after considering the employee's history of exposure to beryllium along
with other risk factors, such as smoking history, family medical
history, age, sex, and presence of existing lung disease.
The seventh and final item required as part of the medical
examination under the proposal was any other test deemed appropriate by
the PLHCP. OSHA explained that other types of tests and examinations
not mentioned in this standard, including X-ray, arterial blood gas,
diffusing capacity, and oxygen desaturation during exercise, may also
be useful in evaluating the effects of beryllium exposure (80 FR
47799). In addition, OSHA noted that medical examinations that include
more invasive testing, such as bronchoscopy, alveolar lavage, and
transbronchial biopsy, have been demonstrated to provide additional
valuable medical information. The Agency preliminarily found that the
PLHCP was in the best position to decide which medical tests are
necessary for each individual examined. Although a requirement for
other tests deemed appropriate by the PLCHP was not included in the
draft joint recommended standard by Materion and USW (Document ID
0754), similar requirements have been included in previous OSHA health
standards, such as Chromium (VI) (29 CFR 1910.1026) and Respirable
Crystalline Silica (29 CFR 1910.1053).
No stakeholders objected to the proposal's requirement that the
medical examination include other tests deemed appropriate by the
PLHCP. However, some commenters offered examples of tests that might be
useful in certain situations. For example, for employees diagnosed with
CBD, NJH recommended that the test battery include pulmonary function
tests including diffusing capacity, exercise tolerance tests, chest X-
ray or CT scan, bronchoscopy with lavage and biopsy, and
bronchoalveolar lavage BeLPT (Document ID 1806, p. 12).
After reviewing the comments on this issue, OSHA reaffirms that
allowing the PLHCP to select other tests is appropriate because there
are no particular tests--beyond those listed in paragraph
(k)(3)(ii)(A)-(E)--that are necessarily applicable to all employees
covered by the medical surveillance requirements. This provision gives
the examining PLHCP the flexibility to determine additional tests
deemed to be appropriate for individual employees. While the tests
conducted under this paragraph are for screening purposes, diagnostic
tests may be necessary to address a specific medical complaint or
finding related to beryllium exposure or the PLHCP may decide that the
test battery needs to be expanded once an employee has been diagnosed
with CBD. Although the tests suggested by NJH have been demonstrated to
provide additional valuable medical information, OSHA considers the
PLHCP to be in the best position to decide if any additional medical
tests, especially the more invasive tests, are necessary for each
individual examined. Under this provision, if a PLHCP decides another
test related to beryllium exposure is medically indicated, the employer
must make it available. OSHA intends the phrase "deemed appropriate"
to mean that additional tests requested by the PLHCP must be both
related to beryllium exposure and medically necessary, based on the
findings of the medical examination.
Information Provided to the PLHCP. Proposed paragraph (k)(4)
detailed which information must be provided to the PHLCP. Specifically,
the proposed standard required the employer to ensure the examining
PLHCP has a copy of the standard, and to provide to the examining PLHCP
the following information, if known to the employer: A description of
the employee's former and current duties that relate to the employee's
occupational exposure ((k)(4)(i)); the employee's former and current
levels of occupational exposure ((k)(4)(ii)); a description of any
personal protective clothing and equipment, including respirators, used
by the employee, including when and for how long the employee has used
that clothing and equipment ((k)(4)(iii)); and information the employer
has obtained from previous medical examinations provided to the
employee, that is currently within the employer's control, if the
employee provides a medical release of the information ((k)(4)(iv)). A
similar requirement was contained in the draft joint recommended
standard by Materion and USW (Document ID 0754, p. 8). However,
Materion and USW's standard did not require written authorization from
the employee for the employer to release medical information to the
PLHCP. OSHA has included similar provisions, with the exception of the
employee's medical release, in previous OSHA standards, such as
Chromium (VI) (29 CFR 1910.1026) and Respirable Crystalline Silica (29
CFR 1910.1053).
OSHA did not receive any comments on the proposed requirement to
provide information to the PLHCP. Therefore, the Agency is including it
in the final standards with three modifications. First, OSHA has
updated paragraph (k)(4)(i) to require the employer to provide a
description of the employee's former and current duties that relate to
both the employee's airborne exposure to and dermal contact with
beryllium, instead of merely requiring the provision of information
related to airborne exposures, as in the proposal. As indicated above
with regard to the medical examination's medical and work history
requirements, OSHA finds that this change is appropriate because the
record indicates that dermal contact with beryllium can lead to
respiratory and dermal sensitization.
Second, OSHA revised the requirement that the employer obtain a
"medical release" before providing the PLHCP with information from
records of employment-related medical examinations. ORCHSE recommended
that paragraph (k)(4)(iv) be revised to indicate that the requirement
to provide medical information to the PLHCP be waived if the employee
refuses to sign a medical release (Document ID 1691, Attachment 1, pp.
10-11). After considering this comment, OSHA finds that a change to the
provision is not needed because the employer can demonstrate a good
faith effort in meeting this requirement by documenting the employee's
refusal to provide a medical release. However, the Agency has chosen to
use the phrase "written consent" instead of "medical release" in
the final standards. This non-substantive change brings the language in
this provision in line with the language used in final paragraphs
(k)(6) and (k)(7), discussed below.
Third, OSHA revised the provision to indicate that the employer
must ensure that the same information provided to the PLHCP is also
provided to the agreed-upon CBD diagnostic center, if an evaluation is
required under paragraph (k)(7) of this standard. OSHA made this change
because the CBD diagnostic center will need the same information as the
PLHCP in order to effectively evaluate the employee.
OSHA concludes that making this information available to the PLHCP
and CBD diagnostic center will aid in the evaluation of the employee's
health as it relates to the employee's assigned duties and fitness to
use personal protective equipment, including respirators, when
necessary. Providing the PLHCP and CBD diagnostic center with exposure
monitoring results, as required under paragraph (k)(4)(ii), will assist
them in determining if an employee is likely to be at risk of adverse
effects from airborne beryllium exposure at work and indicate that
information in the written medical report for the employee. A well-
documented exposure history will also assist the PLCHP in determining
if a condition (e.g., dermatitis, decreased lung function) may be
related to beryllium exposure.
Written medical reports and opinions. Paragraph (k)(5) of the
proposed standard provided for the licensed physician to give a written
medical opinion to the employer, but relied on the employer to give the
employee a copy of that opinion; thus, there was no difference between
information the employer and employee received. The final standards
differentiate the types of information the employer and employee
receive by including two separate paragraphs within the medical
surveillance section that require a written medical report to go to the
employee, and a more limited written medical opinion to go to the
employer. The former requirement is in paragraph (k)(5) of the final
standards; the latter requirement is in paragraph (k)(6) of the final
standards. This summary and explanation for those paragraphs first
discusses the proposed requirements and general comments received in
response during the rulemaking. OSHA then explains in this subsection
of the preamble its decision in response to these comments to change
from the proposed requirement for a single opinion to go to both the
employee and employer and replace it with two separate and distinct
requirements: (1) A full report for the employee, which includes
medical findings, any recommendations on the employee's use of
respirators, protective clothing, or equipment or limitations on
airborne exposure to beryllium, and any recommendations for referral to
a CBD diagnostic center, continued periodic surveillance, and medical
removal; and (2) an opinion for the employer, which focuses primarily
on any recommended limitations on respirator, protective clothing, or
equipment use, and with the employee's consent, recommendations for
referral to a CBD diagnostic center, continued periodic surveillance,
and medical removal. The ensuing two subsections will then discuss the
specific requirements and the record comments and testimony relating to
those specific requirements.
Proposed paragraphs (k)(5)(i)(A)-(C) would have required the
employer to obtain from the licensed physician a written medical
opinion containing: (1) The licensed physician's opinion as to whether
the employee has any detected medical condition that would place the
employee at increased risk of CBD from further airborne exposure to
beryllium; (2) any recommended limitations on the employee's airborne
exposure to beryllium, including the use and limitations of protective
clothing or equipment, including respirators; and (3) a statement that
the PLHCP explained the results of the medical examination to the
employee, including tests conducted, any medical conditions related to
airborne exposure that require further evaluation or treatment, and any
special provisions related to use of protective clothing or equipment.
Proposed paragraph (k)(5)(ii) would have required the employer to
ensure that neither the licensed physician nor any other PLCHP revealed
to the employer specific findings or diagnoses unrelated to airborne
beryllium exposure or contact with soluble beryllium compounds.
Finally, proposed paragraph (k)(5)(iii) would have required the
employer to provide the employee with a copy of the opinion within two
weeks of receiving it.
OSHA asked stakeholders to consider what if any information the
PLHCP should give to the employer. Specifically, the Agency asked
whether it should revise the medical surveillance provisions of the
proposed standard to allow employees to choose what, if any, medical
information goes to the employer from the PLHCP. For example, OSHA
explained, the employer could instead be required to obtain a
certification from the PLHCP stating (1) when the examination took
place, (2) that the examination complied with the standard, and (3)
that the PLHCP provided the licensed physician's written medical
opinion to the employee. Such an approach would require the employee to
provide written consent for the medical opinion or any other medical
information about the employee to be sent to the employer. OSHA asked
stakeholders to comment on the relative merits of the proposed
standard's requirement that employers obtain the PLHCP's written
opinion or an alternative that would provide employees with greater
discretion over the information that goes to employers. OSHA also asked
that commenters explain the basis for their position and the potential
impacts of such an approach (80 FR 47575).
OSHA received a number of comments related to the proposed
provisions and the issues raised. Many of these comments related to the
proposed contents of the PLHCP's written medical opinion and its
transmission to the employer. Some commenters offered suggestions to
address privacy concerns regarding the content of the proposed licensed
physician's written medical opinion and the proposed requirement that
the opinion be given to the employer instead of the employee. For
example, David Weissman, M.D., the director of the Respiratory Health
Division at NIOSH, objected to providing a specific diagnosis to
employers and urged OSHA to adopt a policy consistent with the
International Code of Ethics for Occupational Health Professionals
established by the International Commission on Occupational Health
(Document ID 1725, p. 33; 1815, Attachment 82). The policy recommends
reporting only information on fitness for work and medically related
limitations to management. NIOSH, AFL-CIO, and NABTU also recommended
the ACOEM guidance on confidentiality as a model for the types of
information submitted to the employer (Document ID 1679, p. 13; 1689,
p. 14; 1725, p. 33). The ACOEM guidelines state:
Physicians should disclose their professional opinion to both
the employer and the employee when the employee has undergone a
medical assessment for fitness to perform a specific job. However,
the physician should not provide the employer with specific medical
details or diagnoses unless the employee has given his or her
permission (Document ID 1815, Attachment 60, p. 1).
Exceptions to this recommendation listed under the ACOEM guidelines
include health and safety concerns.
Dr. Weissman also expressed concerns about employers' ability to
ensure the confidentiality of the medical information obtained from
workers (Document ID 1725, pp. 33-34). He argued that if OSHA were to
require diagnoses of beryllium sensitization to be shared with
employers, provisions would be needed to ensure that sensitive
information was protected (Document ID 1725, p. 34). He maintained that
"[s]uch provisions are especially needed because employers are not
necessarily covered entities under the Health Insurance Portability and
Accountability Act (HIPPAA) Privacy Rule" (Document ID 1725, p. 34).
In fact, some employers who commented during the silica rulemaking
expressed concerns about having to maintain confidential medical
information (81 FR 16832).
Commenters representing employee interests also objected to giving
the opinion to the employer, and offered solutions. For example, AFL-
CIO fellow Mary Kathryn Fletcher testified that OSHA should consider
the MSHA requirements for black lung, which requires health care
providers to give their opinion directly to the employee (Document ID
1756, Tr. 201-202; 30 CFR 90.3).
OSHA has accounted for stakeholder privacy concerns in devising the
medical disclosure requirements in the rule. OSHA understands that the
need to inform employers about a licensed physician's recommendations
on work limitations associated with an employee's exposure to beryllium
must be balanced against the employee's privacy interests. As discussed
in further detail below, OSHA finds it appropriate to distinguish
between the licensed physician's recommendations and the underlying
medical reasons for those recommendations. In doing so, OSHA intends
for the licensed physician to limit disclosure to the employer to what
the employer needs to know to protect the employee, which does not
include an employee's diagnosis.
OSHA concludes that the employer primarily needs to know about any
recommended work-related limitations or recommendations without
conveying the medical reasons for the limitations. Thus, consistent
with the weight of opinion in this rulemaking record and with evolving
notions about where the balance between preventive health policy and
patient privacy is properly struck, OSHA is taking a more privacy- and
consent-based approach regarding the contents of the licensed
physician's written medical opinion for the employer. The approach is
similar to the approach that OSHA took in the recently promulgated
Respirable Crystalline Silica standard, but more privacy-based compared
to the proposed beryllium requirements and OSHA standards promulgated
before the Respirable Crystalline Silica standard. These changes, which
are reflected in paragraph (k)(6) of the standards, and the comments
that led to these changes, are more fully discussed below.
Reinforcing the privacy concerns, stakeholders testified about job
loss concerns when employees are diagnosed with an illness. For
example, NABTU's Chris Trahan testified that workers in the
construction industry get laid off if an employer finds out they are
ill (Document ID 1756, Tr. 237-238). Mike Wright, Director of the
Environmental Health and Safety Department, USW, testified that he has
repeatedly seen employers fire employees who are in the early stages of
occupational disease (Document ID 1751, p. 284). Dr. Weissman testified
that if medical results are given directly to the employer, employees
may fear that it would result in loss of their jobs and that would
discourage them from participating in medical surveillance (Document ID
1755, Tr. 47-48). In commenting on a proposed standard provision that
required an employer to get a signed release before sending medical
information to a PLHCP, ORCHSE expressed concerns that employees are
not compelled to sign releases (Document ID 1691, p. 10). The ORCHSE
comment suggests that employees are reluctant to automatically have
their medical information shared with medical professionals, much less
their own employers. These comments mirror concerns voiced in the
recent silica rulemaking. As part of that rulemaking, Dr. Weissman
testified that fear of medical information being shared with employers
is one of the biggest reasons that miners give for not participating in
medical surveillance, and a number of employees testified that they
would not participate in medical surveillance that lacked both employee
confidentiality and anti-
retaliation and discrimination protection (81 FR 16831-16832). In
addition, the Construction Industry Safety Coalition commented that
some employers might refuse to hire an employee with silicosis for fear
that they would be held liable or have to offer workers' compensation
if the disease progressed (81 FR 16832)).
A number of stakeholders, including Southern Company, Ameren, and
NSSP highlighted the importance of reporting beryllium-related findings
to the employer for reasons such as evaluating the effectiveness of
workplace programs and making workplace changes to protect employees
(Document ID 1668, p. 7; 1675, p. 18; 1677, p. 7). NJH reflected
similar views and also indicated that the employer would need medical
information for medical follow-up and removal and to help the employee
file for workers' compensation (Document ID 1664, p. 8). Materion
opposed withholding medical information from employers. It commented
that Materion has a cooperative process where employees are involved in
problem identification and resolution, and when an employee is
diagnosed with sensitization or CBD, senior and safety personnel
conduct an investigation (Document ID 1755, Tr. 172-173; 1807, pp. 4-
5). It indicated that the approach has resulted in improvements aimed
at preventing other workers from developing CBD in the future (Document
ID 1807, pp. 4-5).
Although USW agreed that patient confidentiality is essential, it
argued in comments submitted before the hearing that the employer needs
certain information to comply with the standard, identify over-
exposures, and accommodate the needs of affected employees; it
commented that the proposed rule struck the appropriate balance by
giving the employer needed information while prohibiting the reporting
of medical findings not related to beryllium exposure (Document ID
1681, p. 26). However, at the hearings USW presented a slightly
different view, as Mike Wright testified:
So in this circumstance, we'd like the employer to know that
there's an operation that has caused illness. In a union setting, we
can usually protect people, but we only represent a fraction of the
workforce. In a nonunion setting, and even in the union setting,
people who report an occupational illness put their jobs at peril.
So we tend to resolve that dilemma in terms of privacy (Document ID
1756, Tr. 285).
When questioned how privacy concerns could be balanced with
improving the work environment, Dr. Weissman testified that medical
providers could provide aggregated medical data to employers that would
let employers know there may be a problem but not identify the specific
employees affected (Document ID 1755, Tr. 47-49). He also said that
employers could foster a strong culture of safety so that employees
would be more likely to share medical findings. Dr. Maier, from NJH,
suggested a similar approach of analyzing combined data based on job
task with employees de-identified (Document ID 1756, p. 145). However,
Terry Civic, Director of Safety Health and Regulatory Affairs from
Materion, and Dr. Newman argued that such an approach may not be able
to maintain employee confidentiality in many cases, such as when very
few employees are involved with a process or are employed by a small
company (Document ID 1755, Tr. 173-174; 1756, Tr. 145).
Mr. Wright presented another view when he testified that risk can
be determined in many ways, including air sampling and analyses of work
processes. He went on to say that waiting for an employee to get sick
is the least effective way of determining risk (Document ID 1756, Tr.
284-285). Chris Trahan of NABTU expressed similar thoughts in her
testimony (Document ID 1756, Tr. 240). Rebecca Reindel, Senior Safety
and Health Specialist from AFL-CIO, added:
Employers don't need to hear about a disease in order to
implement engineering controls. It's unlikely that a disease is
necessarily going to trigger engineering controls more than what
OSHA requires in its standards (Document ID 1756, Tr. 240).
OSHA acknowledges that identifying workers with beryllium-related
disease has led to an increased understanding of exposures related to
beryllium disease and development of controls to protect workers, and
OSHA recognizes the efforts of employers who have promoted a strong
health and safety culture and contributed to the knowledge on
beryllium. However, OSHA also recognizes that many employees may fear
possible repercussions of the release of medical information to their
employers.
Moreover, OSHA agrees with commenters who said that employers
should be basing their actions on exposure assessments and implementing
controls, and it encourages employers to regularly evaluate their
beryllium programs. The standards for beryllium require employers to
review and evaluate the written exposure control plan if the employer
is notified that an employee is eligible for medical removal, is
referred to a CBD diagnostic center, or shows signs or symptoms
associated with airborne exposure to or dermal contact with beryllium
(paragraph (f)(1)(ii)(B)). OSHA also encourages analyses of aggregated
data when employers have the resources to do that and are able to
maintain employee confidentially, which is not always possible.
However, in the case where an employee may have disease related to
beryllium exposure and the employer is effectively implementing
controls to maintain exposures within the PEL, the only further action
required by the employer would be to follow the licensed physician's
recommendations to protect the employee who may be especially sensitive
to exposure and may need special accommodations such as continuing
medical examinations at a CBD diagnostic center or medical removal if
requested by the employee. The employer does not need the specific
health findings that contributed to those recommendations.
OSHA examined a number of other factors in determining what the
possible outcomes could be of not providing medical findings to
employers. One possible outcome is that employers would not be able to
report or record illness according to OSHA's standard on recording and
reporting occupational injuries and illnesses (29 CFR 1904). OSHA notes
that if employees do not participate in medical surveillance because of
discrimination or retaliation fears, illnesses associated with
beryllium would also generally not be identified. Although not
disclosing medical information to employers appears inconsistent with
the objective of recording illnesses, the net effect of that decision
to guard employee privacy is improving employee protections due to more
employees participating in medical surveillance.
An additional possible outcome relating to what information goes to
the employer is that withholding information, such as conditions that
might place an employee at risk of health impairment with further
exposure, may leave employers with no medical basis to aid in the
placement of employees. For example, DOD opposed withholding medical
information from employers because the information lets the employer
know if the worker can continue to work without undue risk (Document ID
1684, Attachment 2, pp. 1-7). However, in the recent silica rulemaking,
a number of stakeholders commented that because of the significance of
job loss or modifications, employees that are able to perform work
duties should make their own decisions on whether to continue working
and that such decisions should be made with guidance from the PLHCP (81
FR
16833). OSHA finds that this is also true for beryllium-exposed
employees. As a result of participating in medical surveillance, those
employees will receive information about any health condition they have
that might put them at further risk with exposure to beryllium and
allow them to make employment choices to benefit their health.
Such an approach is not inconsistent with Materion's approach of
letting employees make some employment decisions after learning that
they are sensitized or have CBD, although Materion strongly supports
providing employers with sensitization information (Document ID 1807,
pp. 4-5; Attachment 6, pp. 75-76). At Materion, the confirmed positive
finding is reported to management so an investigation can be conducted,
and the Materion Medical Director informs the employee about the rates
of progression from sensitization to CBD based on Materion's most
recent epidemiological data. If the employee is diagnosed with CBD by
his or her personal pulmonologist, the employee can choose to provide
the information to Materion's Medical Director. Materion reported that
employees "often do [disclose their diagnosis of CBD] in choosing to
apply for Materion benefits under its CBD policy" (Document ID 1807,
p. 4). Under the CBD policy, employees who are physically able to
perform the job are given the choice of remaining in their current job,
taking a job with lower beryllium exposures, or receiving benefits for
12 months. OSHA agrees with Materion's approach of letting employees
decide how to proceed if they are confirmed positive or diagnosed with
CBD, but disagrees that the employer must receive specific health
findings before that can happen.
In review of this evidence, OSHA concludes that if employees decide
to make employment changes to protect their health, there are ways to
communicate recommended limitations or medical removal, without
revealing the specific medical finding leading to those
recommendations. Because of evolving views on medical privacy, such as
those set forth in ACOEM's Confidentiality Guidelines, OSHA does not
find that medical reasons for limitations or medical removal should be
automatically reported to employers. In addition, providing
confidential medical information to all employers presents challenges
in some cases. Unlike Materion, many employers do not have medical
departments and may not therefore be aware of medical privacy laws or
have the resources to maintain medical records under strict
confidentiality.
Another factor that OSHA considered was the value of giving health
information to all employers, when some companies, such as small
businesses, may not have in-house health and safety personnel to answer
employee questions or emphasize the importance of protective measures,
such as work practices or proper use of respirators. In such cases,
employees are not likely to benefit from having their medical findings
given to employers, who may have no deeper knowledge about health risks
than the employee. OSHA expects that the training required under the
standards will give employees knowledge to understand protective
measures recommended by the PLHCP, and will make it more likely they
will authorize PLHCP recommendations to be disclosed to the employer.
As was the case in the silica rulemaking, OSHA agrees that
employees exposed to beryllium have the most at stake in terms of their
health and employability, and they should not have to choose between
continued employment and the health benefits offered by medical
surveillance, which they are entitled to under the OSH Act. OSHA agrees
that employees should make employment decisions, following discussions
with the PLHCP that include the risks of continued exposure. Before
that can happen, however, employees need to have confidence that
participation in medical surveillance will not threaten their
livelihoods. After considering the various viewpoints expressed during
the rulemaking on these issues, OSHA concludes that the best way to
maximize employee participation in medical surveillance, therefore
promoting the protective and preventative purposes of this rule, is by
limiting required disclosures of information to the employer to only
the bare minimum of what the employer needs to know to protect employee
health--recommended restrictions on respirator and protective clothing
and equipment use and, only with consent of the employee, the licensed
physician's recommended limitations on airborne exposure to beryllium
and recommendations for evaluation at a CBD diagnostic center,
continued medical surveillance, and removal from airborne exposure to
beryllium. Thus, OSHA views this consent-based approach to reporting of
medical surveillance findings critical to the ultimate success of this
provision, which will be measured not just in the participation rate,
but in the benefits to participating employees--early detection of
beryllium-related disease so that employees can make decisions to
mitigate adverse health effects and to possibly retard progression of
the disease.
In sum, OSHA concludes that the record offers compelling evidence
for modifying the proposed content of the licensed physician's written
medical opinion for the employer. The evidence includes employee
privacy concerns, as well as evidence on the limited utility for giving
specific medical findings to employers. OSHA is particularly concerned
that the proposed requirements would have led to many employees not
participating in medical surveillance and thus not receiving its
benefits. OSHA therefore has limited the information to be given to the
employer under this rule, but is requiring that the employee receive a
separate written medical report with more detailed medical information.
The requirements for the type of information provided to the
employer are consistent with those in the Respirable Crystalline Silica
standard (29 CFR 1910.1053), but are different from requirements in the
majority of OSHA standards that were promulgated before that standard.
The requirements in other standards remain in effect for those
standards. The requirements for this rule are based on the evidence
obtained during this rulemaking for beryllium, in particular that many
employees, especially those who are not represented by a labor union or
who work in a company that does not foster a strong health and safety
culture, would not take advantage of medical surveillance without
stronger privacy protections.
Licensed Physician's written medical report for the employee. OSHA
did not propose a separate report given directly by the licensed
physician to the employee, but as discussed in detail above, several
commenters requested that a report containing medical information be
given to the employee only. OSHA agrees and in response to those
comments, final paragraph (k)(5) requires the employer to ensure that
the PLHCP explains the results of the medical examination and that the
licensed physician provides the employee with a written medical report
within 45 days of the examination (including any follow-up BeLPT
required under paragraph (k)(3)(ii)(E) of this standard). In other
words, the examination does not end (and trigger the 45-day disclosure
period) until all of the follow-up BeLPTs have been administered. This
deadline is consistent with the deadline for the licensed physician's
written medical
opinion for the employer, which is discussed below.
The contents of the licensed physician's written medical report for
the employee are set forth in final paragraphs (k)(5)(i)-(v). They
include: The results of the medical examination, including any medical
condition(s), such as CBD or beryllium sensitization (i.e., the
employee is confirmed positive, as is defined in paragraph (b) of the
standard), that may place the employee at increased risk from further
airborne exposure; any medical conditions related to airborne exposure
that require further evaluation or treatment; any recommendations on
the employee's use of respirators, protective clothing, or equipment;
and any recommended limitations on airborne beryllium exposure. If the
employee is confirmed positive or diagnosed with CBD, the written
medical report must also contain any recommendations for referral to a
CBD diagnostic center, continued medical surveillance, and medical
removal from airborne beryllium exposures, as described in paragraph
(l) of the standard. Paragraph (l) specifies that medical removal
applies only to work scenarios where airborne exposures exceed the
action level. Paragraph (k)(5)(iii) also states that the licensed
physician may recommend evaluations at a CBD diagnostic center based on
any other reason deemed appropriate. For example, the physician might
recommend an evaluation at a CBD diagnostic center because he or she
suspects that results from the BeLPT are questionable based on signs or
symptoms in the employee or other clinical findings that are consistent
with CBD and wants a specialist in beryllium disease to examine the
employee. However, OSHA notes that recommendations for referrals for
evaluations at CBD diagnostic centers under this standard should only
be given for health-related reasons that pertain to beryllium.
The health-related information in the licensed physician's written
medical report for the employee is generally consistent with the
proposed written medical opinion for the employer, with a few notable
exceptions. The proposal required the written medical opinion to
indicate "whether the employee had any medical condition that would
place the employee at increased risk of CBD from further [airborne]
exposure." Although including a statement in the opinion that "the
employee has a medical condition that places him or her at increased
risk of CBD" implies that the employee is sensitized to beryllium, the
proposal did not require that a specific finding such as "confirmed
beryllium sensitization" be included in the opinion. Because only the
employee will be receiving the written medical report, the written
medical report will include any specific diagnoses, such as CBD or
beryllium sensitization. OSHA added "CBD" as a condition to be
included in the written medical report to the employee because
employees who have CBD may be at risk of increased progression of the
disease if they continue to be exposed. Including a confirmed positive
finding or CBD diagnosis will also give the employee a record of his or
her eligibility for medical removal. An additional change from the
proposed to final requirement is that the proposed phrase of "would
place the employee at risk of CBD from further [airborne] exposure"
was changed to "may place the employee at increased risk from further
airborne exposure." The change of the word "would" to "may" was
for clarification because the word "would" implies a certainty that
does not exist.
The phrase "risk of CBD" was also changed to "risk" to clarify
that risks may be increased by conditions other than CBD-related
disease. For example, the employee may have lung function loss related
to a disease such as chronic obstructive pulmonary disease and that
lung function loss might be compounded if the employee develops CBD. As
noted in the introduction to the Summary and Explanation, the word
"airborne" was included as a modifier to the term "exposure" in
many cases in the final standards to clarify that OSHA did not intend a
change from the proposal. In this provision, OSHA included the term
"airborne" to reaffirm its intent that the report must discuss any
detected medical conditions that may place the employee at increased
risk from further airborne exposure, rather than dermal exposure. OSHA
finds that this distinction is appropriate because it is inhalation
exposure and not dermal contact that increases the risk of CBD
development in a sensitized employee or increases the risk of
progression in an employee who has CBD. (For this same reason the word
"airborne" was added to final paragraph (k)(5)(ii)(B).)
Finally, the proposed phrase "including the use and limitations of
protective clothing and equipment, including respirators" was changed
to "use of respirators, protective clothing or equipment" in final
paragraph (k)(5)(ii)(A). That change reflected an edit to remove
superfluous language and the intent of that requirement has not
changed. OSHA intends this provision to cover situations where the
physician might have recommendations on the use of respirators,
protective clothing or equipment in general, e.g., that the employee
should wear long sleeves to limit the possibility of dermal exposure.
OSHA also intends for the provision to address recommended limitations
on an employee's use of respirators, protective clothing or equipment,
e.g., that the employee cannot safely wear a negative pressure
respirator.
In addition to these changes, OSHA added a number of
recommendations that the licensed physician is to include in the
written medical report to the employee if the employee is confirmed
positive or diagnosed with CBD: (1) Referral for an evaluation at a CBD
diagnostic center (paragraph (k)(5)(iii)), (2) continued medical
surveillance (paragraph (k)(5)(iv)), and (3) medical removal from
airborne exposure to beryllium as described in paragraph (l) (paragraph
(k)(5)(v). Aside from a confirmed positive or CBD diagnosis, if
otherwise deemed appropriate by the licensed physician, the written
medical report must also contain a referral for an evaluation at the
CBD diagnostic center.
Each of these recommendations reflects another requirement of the
final standard. For example, proposed paragraph (k)(6)(i) and (ii)
indicated that an evaluation at a CBD diagnostic center was to occur
when an employee was confirmed positive and agreed to the examination.
OSHA updated the requirement to make it clear that an evaluation at a
CBD diagnostic center should not be limited to employees who have been
confirmed positive and want to find out if they have CBD, and should be
extended to employees already diagnosed with CBD. Such employees would
benefit from having a pulmonologist familiar with beryllium disease
select appropriate tests to monitor progression of the disease. OSHA
therefore expanded the trigger for referral to a CBD diagnostic center
to include CBD in addition to sensitization in final paragraphs
(k)(5)(iii), (k)(6)(iii), and paragraph (k)(7)(i).
The referral for continued medical surveillance for employees who
are confirmed positive or have been diagnosed with CBD reflects the
addition of paragraph (k)(1)(i)(D) that allows employees whose most
recent medical opinion required by paragraph (k)(6) or (k)(7)
recommends periodic medical surveillance to continue receiving medical
examinations, even if they do not qualify under any other trigger; a
more detailed discussion is included under the summary and explanation
for final paragraph (k)(1)(i)(D).
Finally, the triggers for a medical removal recommendation in
paragraph (k)(5)(v) reflect the triggers under paragraph (l)(1)(i) and
are discussed in more detail in the summary and explanation for final
paragraph (l), medical removal protection. OSHA added these
recommendations to the written medical report to make it clear to the
licensed physician and employee that each of these recommendations is
to occur when an employee is confirmed positive or diagnosed with CBD.
A similar approach is applied in the Respirable Crystalline Silica
standard, where the PLHCP is to include a statement that the employee
should be examined by a specialist if that employee has X-ray evidence
of silicosis.
The requirements for the health-related information to be included
in the written medical report for the employee are consistent with the
overall goals of medical surveillance: To identify beryllium-related
adverse health effects so that the employee can consider appropriate
steps to manage his or her health; to let the employee know if he or
she can be exposed to beryllium in the workplace without increased risk
of experiencing adverse health effects; and to determine the employee's
fitness to use respirators. By providing the licensed physician's
written medical report to employees, those who might be at increased
risk of health impairment from airborne beryllium exposure will be able
to consider interventions (i.e., health management strategies) with
guidance from the licensed physician. Such strategies might include
employment choices to limit airborne exposures or using a respirator
for additional protection.
The requirement for a verbal explanation from the PLHCP in
paragraph (k)(5) allows the employee to confidentially ask questions or
discuss concerns with the PLHCP. It also allows the PLHCP to inform the
employee about any non-occupationally related health conditions so that
the employee can follow-up as needed with his or her personal
healthcare provider at the employee's expense. The requirement for a
written medical report ensures that the employee receives a record of
all findings. Employees would also be able to provide the written
medical report to future health care providers.
Licensed physician's written medical opinion for the employer. As
discussed in detail above, some commenters objected to OSHA's proposed
content for the written medical opinion for the employer based on
employee privacy concerns. OSHA shares these privacy concerns and is
thus revising the contents of the written medical opinion. In
developing the contents of the written medical opinion for the
employer, OSHA considered what type of information needs to be included
to provide employers with information to protect employee health, while
at the same time protecting employee privacy as much as possible. NIOSH
commented that the employer should only be provided with information on
the employee's fitness for duty, in addition to restrictions and
eligibility for medical removal benefits, as applicable (Document ID
1725, page pp. 33-34). AFL-CIO recommended that OSHA use the language
from the respirable crystalline silica rule promulgated in March of
2016, and referred OSHA to the final brief it submitted for the silica
rulemaking since the justifications for increased confidentiality apply
to beryllium (Document ID 1809, p. 1; 1786). In the silica standard,
OSHA required that only limitations on respirator use be included in
the written medical opinion without the employee's consent. The
decision was largely influence by physician testimony that giving the
employer information on an employee's ability to use a respirator, but
not specific medical information, strikes the appropriate balance
between the employee's privacy and the employer's right to know because
employees who are not fit to wear a respirator and then do so can be at
risk of sudden incapacitation or death (81 FR 16835; see also Document
ID 1786; pp. 89-90; 1805, Attachment 2, p. 133).
Based on the record evidence, OSHA has determined that for the
beryllium standards, the written medical opinion for the employer must
contain only the date of the examination, a statement that the
examination has met the requirements of this standard, and any
recommended limitations on the employee's use of respirators,
protective clothing, and equipment; and a statement that the PLHCP
explained the results of the examination to the employee, including any
tests conducted, any medical conditions related to airborne exposure
that require further evaluation or treatment, and any special
provisions for use of personal protective clothing or equipment. These
requirements are set forth in paragraph (k)(6)(i) of the standards.
OSHA is persuaded to include recommended limitations on the
employee's use of respirators, protective clothing, and equipment, with
no other medically-related information, in the written medical opinion
for the employer without further consent from the employee. The Agency
notes that the limitation on respirator use is consistent with
information provided to the employer under the Respiratory Protection
standard (29 CFR 1910.134). OSHA concludes that only providing
information on respirator and protective clothing and equipment
limitations in the written medical opinion for the employer is
consistent with the ACOEM confidentiality guidelines that address the
reporting of health and safety concerns to the employer (Document ID
1815, Attachment 60, p. 1). The date and statement about the
examination meeting the requirements of this standard are to provide
both the employer and employee with evidence that compliance with the
medical surveillance requirements are current. Employees will be able
to show this opinion to future employers to demonstrate that they have
received the medical examination.
Paragraph (k)(6)(ii) states that if the employee provides written
authorization, the written medical opinion for the employer must also
contain any recommended limitations on the employee's airborne exposure
to beryllium. Paragraphs (i)(6)(iii)-(v) state that if an employee is
confirmed positive or diagnosed with CBD and the employee provides
written authorization, the written opinion must also contain
recommendations for evaluation at a CBD diagnostic center, continued
medical surveillance, and medical removal from airborne exposure to
beryllium as described in paragraph (l). If otherwise deemed
appropriate by the licensed physician and the employee authorizes the
information to be included in the written medical opinion, the opinion
must also contain a referral for an evaluation at the CBD diagnostic
center. As noted above, referrals for evaluations at CBD diagnostic
centers under this standard should only be given for health-related
reasons that pertain to beryllium.
OSHA intends for this provision to allow the employee to give
authorizations for the written medical opinion for the employer to
contain only the referral for evaluation at a CBD diagnostic center,
only the recommendation for continued periodic surveillance, or only
the recommendation for medical removal, or both. This will allow
employees to choose one or more options that best fit their needs. For
example, an employee may choose to only let the employer know that he
or she wants continued medical surveillance but not at the CBD
diagnostic center because he or she is satisfied with the care provided
by the current PLHCP. In another case, an employee may decide that he
or she
wants only the recommendation for evaluation at a CBD diagnostic center
reported to the employer because the employer wants to be evaluated by
someone who is more specialized in beryllium disease before making any
major employment decisions. In a third case, the employee may only want
the recommendation for removal from airborne exposure reported to the
employer because the employee is very concerned about his or her health
and wants to be immediately removed without an evaluation at the CBD
diagnostic center. OSHA expects that the written authorization could
easily be accomplished through the use of a form that allows the
employee to check, initial, or otherwise indicate which (if any) of
these items discussed above the employee wishes to be included in the
written medical opinion for the employer. OSHA concludes that allowing
the employee to decide what if any additional information can be
reported to the employer is warranted based on the seriousness and
irreversibility of beryllium disease and the major impact that the
decision may have on the employee's health and employment.
OSHA is convinced that routinely including recommended limitations
on airborne exposure, evaluations at a CBD diagnostic center, and
especially medical removal in the written medical opinion for the
employer absent employee consent could adversely affect employees'
willingness to participate in medical surveillance. The requirements
for this paragraph are consistent with recommendations to let employees
make their own health decisions. OSHA stresses that information given
to the employer should not include an underlying diagnosis--only the
specific recommendation or referral called for under the standards.
OSHA considers this a reasonable approach that balances the need to
maintain employee confidentiality with the employer's need to know that
it may want to reevaluate its beryllium program. Reporting that a
referral or medical removal is recommended, when authorized by the
employee, allows the employer to reevaluate its written exposure
control plan, as required under paragraph (f)(1)(ii)(B).
OSHA finds that this new format for the licensed physician's
medical opinion for beryllium will better address concerns of ORCHSE,
who feared it would be in violation if the written medical opinion for
the employer included information that OSHA proposed the licensed
physician or PLHCP not report to the employer, such as an unrelated
diagnosis (Document ID 1691, p. 11). OSHA finds that removing the
prohibition on unrelated diagnoses and instead specifying the only
information that is to be included in the written medical opinion for
the employer remedies this concern because it makes the contents of the
opinion easier to understand and less subject to misinterpretation.
OSHA recognizes that some employees might be exposed to multiple
OSHA-regulated substances at levels that trigger medical surveillance
and requirements for written opinions. For example, Newport News
Shipbuilding indicated that their employees already undergo medical
surveillance for arsenic (Document ID 1657, p. 2). The licensed
physician can opt to prepare one written medical opinion for the
employer for each employee that addresses the requirements of all
relevant standards, as noted in preambles for past rulemakings, such as
Chromium (VI) (71 FR 10100, 10365 (2/28/06)). However, the combined
written medical opinion for the employer must include the information
required under each relevant OSHA standard. For example, if the PLHCP
opts to combine written medical opinions for an employee exposed to
both inorganic arsenic and beryllium, then the combined opinion to the
employer must contain the information required by paragraphs (n)(6)(i)
of the inorganic arsenic standard (29 CFR 1910.1018) and the
information required by paragraphs (k)(6)(i) (and paragraphs
(k)(6)(ii)-(v) with written authorization from the employee) of the
beryllium standards.
NABTU noted that the black lung rule for coal miners protects
confidentiality by prohibiting mine operators from requiring miners to
provide a copy of their medical information (Document ID 1679, p. 13;
30 CFR 90.3). NABTU requested that the beryllium rule protect
confidentiality by prohibiting employers from asking employees or the
PLHCP for medical information (Document ID 1679, p. 13). Consistent
with the Respirable Crystalline Silica standard, OSHA is not including
such a prohibition in the beryllium standard because employers may have
legitimate reasons for requesting medical information, such as BeLPT
results. For example, employers might request such information for
doing an investigation or helping employees file compensation claims.
If employees are not concerned about discrimination or retaliation, or
need the employer's help in filing a claim, they could provide the
health information to the employer. Paragraph (k)(6)(vi) requires the
employer to ensure that employees receive a copy of the written medical
opinion for the employer within 45 days of any medical examination
(including any follow-up BeLPT required under paragraph (k)(3)(ii)(E)
of this standard) performed for that employee. The reason for the 45-
day deadline to provide the written medical opinion is discussed below.
OSHA is requiring that employees receive a copy of the written medical
opinion for the employer, in addition to the written medical report,
because they can present the written medical opinion as proof of a
current medical examination to future employers. This is especially
important in industries with high turnover because employees may work
for more than one employer during a two-year period and this ensures
that tests are not performed more frequently than required.
On the topic of transient employment, NSC asked OSHA to consider
workers employed by staffing agencies and assigned to multiple host
employers and possibly employees of contractors to the host employer,
who might not receive medical surveillance because of the transient
nature of their employment (Document ID 1612, p. 3). OSHA's July 15,
2014, memorandum titled Policy Background on the Temporary Worker
Initiative indicates that both the host and staffing agency are
responsible for the health and safety of temporary employees. For
example, the policy memorandum indicates that host employers are well
suited for assuming responsibility for compliance related to workplace
hazards, while staffing agencies may be best positioned to provide
medical surveillance. Under this policy, staffing agencies are expected
to offer medical surveillance to eligible employees, and they could
send a copy of the written medical opinion to the host employer so that
the host employer would know about any limitations that might be
recommended by the licensed physician. Similarly contract employers
whose employees work at different job sites are expected to offer
medical surveillance to their eligible employees. Also, OSHA revised
the triggers for medical surveillance in paragraphs (k)(1)(i)(A) and
(k)(2)(i)(A) so that employees must be offered medical surveillance
within 30 days of when the employer determines they are reasonably
expected to be exposed above the action level for 30 or more days a
year. The revised trigger allows for more timely medical examinations
than the proposed trigger, which would have allowed for the employee to
be exposed for 30 days before the employer had to offer medical
surveillance. As a result, more temporary workers who are
employed for short periods of time will meet the trigger for medical
surveillance.
As indicated above, the standards require that employers ensure
that employees get a copy of the PLHCP's written medical report and
opinion and that they get a copy of the written opinion within 45 days
of each medical examination (including any follow-up BeLPT required
under paragraph (k)(3)(ii)(E) of this standard) (paragraphs (k)(5),
(k)(6)(i), (k)(6)(vi)). By contrast, the proposed rule would have
required that the employer obtain the licensed physician's written
medical opinion within 30 days of the medical examination and then
provide a copy to the employee within 2 weeks after receiving it. NJH
commented that 45 days is a better time period for notifying employers
because it can take more than 2 weeks to process the BeLPT (Document ID
1664, p. 8). ORCHSE expressed concern about the 30-day timeline,
stating that the employer would be in violation if the physician took
more than 30 days to deliver the report (Document ID 1691, pp. 11-12).
In light of NJH and ORCHSE's comments, OSHA has revised the
proposed 30-day timeline to allow for 45 days. OSHA expects that the
new 45-day period will give the licensed physician sufficient time to
consider the results of any tests, including a follow-up BeLPT, done as
part of the examination. OSHA finds that delivering the report to the
employer within 45 days will still ensure that the employee and
employer are informed in a timely manner and allows the employer to
take any necessary protective measures within a reasonable time period.
To ensure timely delivery of reports and opinions containing the
correct information and demonstrate a good faith effort in meeting
these requirements of the standard, the employer could inform licensed
physicians about the time deadline and other requirements of the
beryllium standard in a written agreement and follow up with the
physician if there is concern about timely delivery or content of these
documents. Because the licensed physician will be providing the
employee with a copy of the written medical report, he or she could
give the employee a copy of the written medical opinion at the same
time. This would eliminate the need for the employer to give the
employee a copy of the PLHCP's written medical opinion for the
employer, but the employer would still need to ensure timely delivery.
OSHA has also revised this provision to account for the time to
administer any follow-up BeLPT tests required under paragraph
(k)(3)(ii)(E) of these standards. As discussed above, if the results of
the BeLPT are other than normal, paragraph (k)(3)(ii)(E) requires a
follow-up BeLPT to be offered within 30 days, unless the employee has
been confirmed positive. In order to allow for the licensed physician
to consider BeLPT results and prepare the written medical opinion, the
Agency must allow time for the BeLPT to be administered, processed, and
interpreted. Therefore, OSHA has decided to require the employer to
obtain a written medical opinion from the licensed physician within 45
days of the medical examination (including any follow-up BeLPT required
under paragraph (k)(3)(ii)(E) of this standard).
Evaluation at a CBD Diagnostic Center. OSHA proposed that within 30
days after an employer learned that an employee was confirmed positive,
the licensed physician was to consult with the employee to discuss
referral to a CBD diagnostic center that was mutually agreed upon by
the employer and employee (proposed paragraph (k)(6)(i)). Following the
consultation, if the employee decided to be clinically evaluated at a
CBD diagnostic center, the employer was to provide the examination at
no cost to the employee (proposed paragraph (k)(6)(ii)).
OSHA asked stakeholders to comment on the proposed requirement for
evaluation at a CBD diagnostic center, especially whether the
requirements for mutual agreement by the employee and employer is
necessary and appropriate and how the diagnostic center should be
chosen if the employer and employee cannot agree. OSHA also asked
whether the standard should specify that evaluation at a diagnostic
center must be at a reasonable location (80 FR 47574-47575).
The term CBD diagnostic center is defined in paragraph (b),
Definitions, of the standards. As provided in paragraph (b) and
explained in the Summary and Explanation, the CBD diagnostic center can
be a hospital or other facility that has an on-site pulmonary
specialist who can interpret biopsy pathology and bronchoalveolar
lavage (BAL) results. The diagnostic center must also have onsite
facilities that can do a clinical evaluation for CBD that includes
pulmonary function testing according to ATS guidelines, transbronchial
biopsy, and BAL, with the ability to transfer BAL samples to a
laboratory for diagnostic evaluation within 24 hours.
Ameren supported a specialist exam but asserted that an examination
by a pulmonologist was sufficient and that the pulmonologist could be
allowed to work with a CBD diagnostic center to treat a sensitized
employee (Document ID 1675, p. 17). Southern Company argued that rather
than requiring an evaluation at a CBD diagnostic center, the standard
should instead specify the types of exams required (Document ID 1668,
pp. 2-3). DOD commented that employees should be referred to a board-
certified pulmonologist who is capable of doing bronchoscopy, bronchial
biopsy, and broncho-alveolar lavage (Document ID 1684, Attachment 2, p.
1-6), NSSP, NABTU, ACOEM, and ATS advocated for an examination at a CBD
center for sensitized employees (Document ID 1677, p. 6; 1679, p. 12;
1685, p. 5; 1688, p. 3).
OSHA is not persuaded by Southern Company's argument that the final
standards should detail specific tests for confirmed positive
employees, instead of requiring an examination at a CBD diagnostic
center. As described above, the types of evaluations required for an
employee who has a confirmed positive finding or is diagnosed with CBD
must be determined on a case-by-case basis, and therefore determining
appropriate testing requires a pulmonologist with the expertise
described in the definition for CBD diagnostic center. In addition,
many of the procedures that a pulmonologist may recommend are invasive
and therefore involve risks. As a result, these tests should only be
performed by a pulmonologist familiar with beryllium disease at a
facility that meets the definition of a CBD diagnostic center, after
the pulmonologist has carefully considered the employee's medical and
occupational history. For these reasons, OSHA reaffirms that it is
essential that eligible employees be evaluated at a CBD diagnostic
center. Requiring that the diagnostic center be able to perform all the
functions described under the Definitions section also makes the exam
more convenient for the employer and the employee because the employee
will not have to go to multiple facilities in order to undergo
different procedures.
Southern Company disagreed with the proposed requirement that both
the employee and employer agree upon the CBD diagnostic center,
asserting that the requirement could conflict with selection of a
physician under workers' compensation laws, because OSHA does not have
a mechanism to settle disputes, and because similar requirements are
not included in other OSHA standards (Document ID 1668, pp. 6-7).
Ameren and ORCHSE also opposed the requirement for mutual agreement on
a CBD diagnostic center and recommended that location be considered
when the employee and employer cannot reach agreement
(Document ID 1675, p. 17; 1691, p. 10). NJH supported mutual agreement
on the CBD diagnostic center between the employee and employer and
stated that location, expertise of the center, and feasibility should
all be accounted for when agreement cannot be reached (Document ID
1664, p. 8).
OSHA acknowledges the concerns of these stakeholders, but maintains
that the employee should be given a choice in the selection of a CBD
diagnostic center because of the risks involved with procedures that
the employee may have to undergo and because of the life-changing
decisions that the employee might have to make based on the results of
the evaluation. The employer and employee should make a good faith
effort to agree on a CBD diagnostic center that is acceptable to them
both. In making the decision, the first consideration is identifying
qualified CBD diagnostic centers. The next considerations in the
decision should include requirements under other laws and geographical
location. OSHA expects that once these criteria are considered, there
will not be unlimited options, which will help the employee and
employer come to a decision.
Although OSHA was not convinced that changes needed to be made
based on public comments, OSHA did find changes were required to make
the final provision consistent with other requirements of the final
standard. First, OSHA changed the trigger for referral to a CBD
diagnostic center to include both confirmed positive and a CBD
diagnosis for consistency with paragraphs (k)(5)(iii) and (k)(6)(iii).
The reasoning for this change is described above in the discussion of
paragraph (k)(5)(iii). Second, OSHA removed the requirement for a
consultation between the physician and employee within 30 days after
the employer learned that the employee was confirmed positive. Under
paragraph (k)(6)(D), the employer already must ensure that the PLHCP
explains findings to the employee, including conditions related to
airborne beryllium exposures that require further evaluation or
treatment within 30 days of the medical examination. The discussion
about recommended referral can occur as part of that conversation, and
OSHA does not find that a separate consultation with the physician or
PLHCP is necessary.
The third major change to this provision was detailing how the
employer would be informed that the employee is eligible for an
evaluation at a CBD diagnostic center. The change reflects updates made
to paragraph (k)(6) to allow the employee more privacy and control over
the type of information the employer receives. Under final paragraph
(k)(6), the employee must authorize the written medical opinion to
contain recommendations for an evaluation at a CBD diagnostic center,
and the licensed physician would then provide the employer that
recommendation in the written medical opinion. Under paragraph (k)(5),
the employee's written medical report is to contain medical findings,
including a confirmed positive test result and a CBD diagnosis. The
report must also contain a referral for an evaluation at a CBD
diagnostic center if the employee is confirmed positive or diagnosed
with CBD or if the licensed physician otherwise deems it appropriate.
The employee has the option of providing the employer with a copy of
the written medical report indicating a confirmed positive finding or
diagnosis of CBD, or recommending referral. OSHA is providing the
option for a written medical report listing a confirmed positive
finding or diagnoses of CBD to be offered as proof of eligibility for
an evaluation at a CBD diagnostic center, in the event that a licensed
physician did not recommend a referral to a CBD diagnostic center in
either the written medical report or the written medical opinion.
As the result of the changes discussed above, final paragraph
(k)(7) requires that employers provide a no-cost evaluation at a CBD-
diagnostic center that is mutually agreed upon by the employee and
employer within 30 days of receiving a medical opinion that recommends
the referral (paragraph (k)(7)(i)(A)) or within 30 days after the
employee presents the employer with a written medical report indicating
that the employee has been confirmed positive or diagnosed with CBD, or
recommending referral to a CBD diagnostic center (paragraph
(k)(7)(i)(B)). As is the case with the PLHCP's examination, the
employer is responsible for providing the employee with a medical
examination at a CBD diagnostic center, at no cost, and at a reasonable
time and place.
Under paragraph (k)(7)(ii) of the standards the employer must
ensure that the CBD diagnostic center explains medical findings to the
employee and gives the employee a written medical report within 30 days
of the examination. Like the licensed physician's written medical
report, the written medical report from the CBD diagnostic center must
contain the results of the examination, including conditions such as
sensitization or CBD that might increase the employee's risk from
airborne exposure to beryllium; any medical conditions related to
beryllium that require further follow-up; any recommendations on the
employee's use of respirators, protective clothing, or equipment; and
any recommended limitations on beryllium exposure. If the employee is
confirmed positive or diagnosed with CBD, the written medical report
must also contain recommendations for continued periodic medical
surveillance and recommendations for removal from exposure to
beryllium, as described in paragraph (l). The reasons why the CBD
diagnostic center is to give the employee this information are the same
as discussed above, under the requirements for the licensed physician's
written medical report for the employee. This provision was added to
the final standards to ensure that the employee gets a written record
from the CBD diagnostic center and to allow the employee to consult
with the CBD diagnostic center about the findings.
Paragraph (k)(7)(iii) requires that the CBD diagnostic center
provides the employer with a written medical opinion within 30 days of
the medical examination. The written medical opinion must contain the
date of the examination, any recommended limitations on the employee's
use of respirators, protective clothing, or equipment, and a statement
that a PLHCP explained the results of the medical examination to the
employee. It must also contain a statement that the examination met the
requirements of the standard, if a periodic examination was conducted
for an employee who chooses examinations conducted at the CBD
diagnostic center as specified under paragraph (7)(iv). If the employee
provides written authorization, the written medical opinion for the
employer must also contain any recommended limitations on the
employee's airborne exposure to beryllium. If an employee is confirmed
positive or diagnosed with CBD and the employee provides written
authorization, the written opinion must also contain recommendations
for continued medical surveillance, and/or medical removal from
exposure to beryllium, as described in paragraph (l).
This provision was not in the proposed standard or the joint draft
recommended standard by Materion and USW but was added to the final
standards to allow for transmittal of CBD diagnostic center
recommendations to the employer without revealing the specific medical
reason for those recommendations. The structure parallels the written
medical opinion from the licensed physician, which was developed based
on stakeholder requests to increase confidentiality of
medical findings. A separate written medical opinion from the CBD
diagnostic center is needed because the recommendations may differ from
those of the licensed physician and usually comes from a different
provider. For example, the employee may have wanted only a
recommendation for evaluation at a CBD diagnostic center to be included
on the written medical opinion from the physician, but, after
evaluation at a CBD diagnostic center, may decide to include the
recommendation for medical removal from exposure on the CBD diagnostic
center's written medical opinion.
Paragraph (k)(7)(iv) requires the employer to ensure that each
employee receives a copy of the written medical opinion from the CBD
diagnostic center described in paragraph (k)(7) of this standard within
30 days of any medical examination performed for that employee. As
discussed above with regard to paragraph (k)(6)(vi), requiring the
provision of all written medical opinions to employees can permit
employees to provide that information to future employers without
divulging private medical information and also present the opinion as
proof of a current examination that meets the requirements of the
beryllium standard.
The deadlines for submittal of the written medical opinion and
report are shorter for the CBD diagnostic center (30 days) than the
licensed physician (45 days). The reasoning is because CBD diagnostic
centers are not expected to routinely conduct BeLPTs, which as noted
above, take 2 weeks to process. They will not, therefore, be affected
by the same time limitations as licensed physicians.
In the NPRM, OSHA asked stakeholders to comment on whether
sensitized employees should be given the opportunity to be examined at
a CBD diagnostic center more than once and how frequently those
employees should be evaluated (80 FR 47574). This provision was not
included in the draft standard or the joint draft recommended standard
by Materion and USW (Document ID 0754).
NABTU commented that a sensitized employee should continue to be
periodically evaluated at a CBD diagnostic center because it cannot be
predicted when a sensitized employee will develop CBD (Document ID
1679, p. 12). NSSP, ACOEM, and ATS agreed with continued periodic
surveillance at a CBD diagnostic center for sensitized employees
(Document ID 1677, p. 6; 1685, p. 5; 1688, p. 3). ATS recommended that
sensitized employees be evaluated every one to three years and NSSP
recommended that the original physician, CBD diagnostic center, and
employee determine the frequency of medical examinations. Finally,
Ameren stated that the standard should allow for follow-up based on
pulmonologist recommendations (Document ID 1675, p. 16).
OSHA agrees that continued evaluation at a CBD diagnostic center is
appropriate for sensitized employees and employees diagnosed with CBD.
Specialized evaluation is needed to determine the appropriate tests to
monitor for possible progression from sensitization to CBD and to
monitor the progression of CBD if it does occur. Therefore, after
considering the record, OSHA added the requirement for continued
evaluation at a CBD diagnostic center for these employees.
This new requirement is contained in paragraph (k)(7)(v), which
specifies that after an employee has received a clinical evaluation at
a CBD diagnostic center described by paragraph (k)(7)(i) of the
standards, the employee may choose to have any subsequent medical
examinations for which the employee is eligible under paragraph (k) of
this standard performed at a CBD diagnostic center. The evaluations
must continue to be done at a CBD diagnostic center mutually agreed
upon by the employee and employer and provided at no cost to the
employee. To allow for continued medical surveillance for those
employees who would not otherwise be entitled under (k)(1) or (k)(2),
the employee must authorize the recommendation for continued periodic
medical surveillance to be included in the most recent written medical
opinion from the CBD diagnostic center (paragraph (k)(7)(iii)). Under
paragraph (k)(2)(ii), the CBD diagnostic center can recommend continued
surveillance every two years. OSHA is not including a provision for
more frequent examinations because, as indicated above, surveillance
done every two years is appropriate to monitor for sensitization and
CBD progression in most employees.
Proposed paragraph (k)(7) had required that employers were to
convey the results of beryllium sensitization tests to OSHA for
evaluation and analysis at the request of OSHA. The employer was to
remove all personally identifiable information (e.g., names, social
security numbers) before sending the results to OSHA. A similar
provision was included in the joint draft recommended standard by
Materion and USW. OSHA asked for comment on this provision,
specifically if such a requirement would be burdensome for employers
and whether it would be more appropriate to send the information to
other organizations (80 FR 47575).
Some commenters did not support the inclusion of this requirement
in the final rule. For example, Ameren commented that the proposed
requirement would be burdensome because it would be cumbersome to get
signed releases for this information (Document ID 1675, p. 20). ORCHSE
also argued that employees would have a difficult time complying with
this requirement because employees would not likely sign a release
(Document ID 1691, p. 13). DOD also claimed that the requirement would
be burdensome and said that it would be better to send the results to
NIOSH but not routinely (Document 1684, Attachment 2, pp. 1-7-1-8). On
the other hand, NJH supported this requirement because it believed the
information would help OSHA identify industries where sensitization is
occurring (Document ID 1664, p. 9). However, NJH added that small
companies may need help complying with this requirement (Document ID
1664, p. 9). In addition, NJH and ATS recommended that the rule specify
that employers routinely and systematically analyze medical screening
results along with job and exposure data to identify employees who may
be at risk of sensitization and working conditions contributing to
sensitization and CBD risk (Document ID 1664, p. 8; 1688, 4).
Consistent with the concerns of Ameren and ORCHSE regarding getting
releases from employees, OSHA has given much thought to maintaining
confidentiality of medical findings as discussed in detail above. As a
result of changes made in the standards to enhance employee privacy,
the Agency eliminated the proposed paragraph for the written medical
opinion to the employer to include a statement about whether the
employee had a condition that would put him or her at risk of
developing CBD with further beryllium exposure. That provision
suggested that the written medical opinion might include findings such
as beryllium sensitization. In the final standard, it is explicit that
the employer will not receive information about sensitization or CBD in
the written medical opinion to the employer, and the employer will only
receive that information when an employee presents the employer with
the employee's written medical report. As a result, many employers may
not have that information to submit to OSHA or to otherwise conduct a
systematic analysis of medical screening results. As discussed above,
even if employers were provided aggregated medical findings, it may
still be difficult
to maintain confidentiality when companies are small or few employees
are involved in a process.
OSHA has other ways to obtain medical findings if needed. For
example, as noted in the Summary and Explanation for paragraph (n),
Recordkeeping, OSHA's Access to Employee Exposure and Medical Records
standard (29 CFR 1910.1020) requires employers to ensure that most
employee medical records are retained for the duration of employment
plus 30 years for employees employed more than one year, and requires
that those records be made available to OSHA upon request (29 CFR
1910.1020 (d)(1)(i) and (e)(3)). OSHA therefore deleted proposed
paragraph (k)(7) from the final standard.
(l) Medical Removal
Paragraph (l) of the standards for general industry, shipyards, and
construction provide for medical removal protection (MRP). This
paragraph applies only to workers with airborne exposure to beryllium
at or above the action level who are diagnosed with CBD or confirmed
positive and provide documentation of their diagnosis of CBD or
confirmed positive status or a physician's recommendations for removal
from exposure to beryllium to their employers. Under this paragraph,
employees must provide eligible employees with a choice of removal from
exposure at or above the action level or remaining in their job with
airborne exposure at or above the action level and wearing a
respirator. If the employee chooses removal, the employer is required
to remove the employee to comparable work in a work environment where
the airborne exposure is below the action level, if such work is
available. If comparable work is not available, the employer must
maintain the employee's base earnings, seniority, and other rights and
benefits that existed at the time of removal for six months or until
such time that comparable work described in paragraph (l)(3)(i) becomes
available, whichever comes first. The employee's earnings under MRP can
be diminished by the amount of compensation received from certain other
sources.
OSHA included medical removal provisions in the proposed rule as a
protective, preventative health mechanism that was intended to work in
concert with the proposed medical surveillance provisions. As OSHA
explained in the proposal, the Agency preliminarily found that medical
removal is an important means of protecting employees who have become
sensitized or developed CBD, and is an appropriate means to enable them
to avoid further exposure. See 80 FR 47802. The Agency further
explained that the inclusion of MRP in the proposal was in keeping with
the recommendation of beryllium health specialists in the medical
community and with the draft recommended standard provided by union and
industry stakeholders (Document ID 0754).
OSHA solicited comments on the health effects that should trigger
MRP and the proposed provisions for MRP. In addition, the Agency
included several specific questions to guide stakeholders in their
response, including whether beryllium sensitization and CBD are
appropriate triggers for medical removal, whether there were other
medical conditions or findings that should trigger medical removal, and
the amount of time for which a removed employee's benefits should be
extended. OSHA also included questions regarding the costs and benefits
of MRP (see 80 FR 47575).
During the public comment periods and informal public hearing,
numerous stakeholders submitted comments supporting the inclusion of
MRP in this rulemaking (e.g., Document ID 1664, pp. 3-4, 9; 1680, pp.
1, 7; 1681, p. 14-15; 1683, p. 3; 1688, p. 2; 1689, pp. 8, 13-14; 1690,
pp. 1, 3-4; 1691, Attachment 1, pp. 13, 15; 1755, Tr. 26, 168; 1756,
Tr. 142-143; 1809, p. 1; 1963, pp. 13-14). The commenters who commented
on the issue supported MRP in general terms; none opposed inclusion of
MRP in the final rule. Some of these stakeholders noted that they
supported MRP because it promotes participation in medical surveillance
programs. For example, National Council on Occupational Safety and
Health (National COSH) argued that MRP benefits are crucial to a
successful medical surveillance program (Document ID 1690, pp. 3-4).
National COSH maintained that "workers will not willingly participate
in medical surveillance or disclose early signs and symptoms of disease
if doing so means they lose their job and can no longer pay their
bills. For this reason, an effective medical surveillance program for
CBD must include . . . [MRP] benefits" (Document ID 1690, p. 3). NIOSH
similarly argued that "[f]ear of job loss and associated loss of
income and other benefits is an important barrier to translating
medical screening and surveillance findings into secondary prevention.
Inclusion of medical removal provisions is critical to addressing that
barrier" (Document ID 1755, Tr. 26). The American Association for
Justice agreed, observing that "MRP benefits are an essential tool to
ensure that workers with signs and symptoms of disease step forward
without fear of reprisal and seek medical advice" (Document ID 1683,
p. 3).
Other commenters indicated that the option for removal was
necessary for workers' health. For example, the USW argued that the
inclusion of MRP is necessary to provide a safe and healthful workplace
(Document ID 1963, p. 13). USW further commented that Section VIII
(Significance of Risk) of the NPRM shows that existing evidence within
the docket indicates that workers who are sensitized to beryllium or
are in the early stages of chronic beryllium disease can significantly
benefit from MRP (Document ID 1963, p. 13). National Jewish Health
(NJH) generally agreed with USW's opinion, stating that "removal from
exposure is the best form of prevention" (Document ID 1664, p. 4).
Other stakeholders indicated that the inclusion of a medical
removal provision might lower exposures in the workplace as a whole.
For example, USW testified that MRP provides employers with a financial
incentive to keep beryllium exposures low (Document ID 1755, Tr. 167-
68). Mike Wright from USW observed that this incentive helped to lower
exposure levels in the context of the lead standard:
But what really, I think, best protected workers was medical
removal protection because employers did not want to pay people to
stay at home until their blood leads got down. So I think if you
look at the real benefits of MRP, it isn't simply that it removes
workers from exposure, who might be harmed by further exposure. It
is that it really provides an incentive for employers to keep
exposures low in the first place. And that's been our experience
(Document ID 1755, Tr. 167-68).
After careful consideration of these comments, OSHA has decided to
include MRP in the final standards. As noted by commenters, MRP serves
three main interrelated purposes. First, it increases employee
participation and confidence in the standards' medical surveillance
program. Under paragraph (k)(1)(i)(B), employers must offer medical
examinations to employees showing signs or symptoms of CBD. The success
of that program will depend in part on employees' willingness to report
their symptoms, submit to examinations, respond to questions, and
comply with instructions. Guaranteeing comparable work or earnings,
seniority, and other rights and benefits for a period of time can help
allay an employee's fear that a CBD diagnosis or
being confirmed positive will negatively affect earnings or career
prospects. MRP encourages employees to report their symptoms and seek
treatment, as OSHA has previously recognized when including medical
removal in regulations governing the exposure to Lead (43 FR 52952,
52973, November 14, 1978), Benzene (52 FR 34460, 34557, September 11,
1987), and Cadmium (57 FR 42102, 42367-42368, September 14, 1992). This
reasoning was also cited by the Department of Energy in support of the
medical removal provisions of its Chronic Beryllium Disease Prevention
Program, stating that the availability of medical removal benefits
encourages worker participation and cooperation in medical surveillance
(64 FR 68893).
Second, by requiring the employer to remove employees with the
highest risk of suffering material impairment of health (if the
employee chooses removal), MRP may benefit sensitized employees and
those with CBD. OSHA notes that there remains some scientific
uncertainty regarding the effects of exposure cessation on the
development of CBD among sensitized individuals and the progression
from early-stage to late-stage CBD. For example, Steven Markowitz, MD,
a medical consultant for USW, acknowledged during the informal public
hearing that "there's a paucity of evidence that removal from exposure
results in improvement of CBD" (Document ID 1755, Tr. 101).
Nonetheless, most members of the medical community support removal from
beryllium exposure as a prudent step in the management of beryllium
sensitization and CBD. As noted above, physicians at NJH recommend that
individuals diagnosed with beryllium sensitization and CBD who continue
to work in a beryllium industry should have exposure of no more than
0.01 micrograms per cubic meter of beryllium as an 8-hour TWA, which is
10 times below the action level of 0.1 micrograms per cubic meter
(http://www.nationaljewish.org/healthinfo/conditions/beryllium-disease/environment-management/) (Document ID 0637). Furthermore, OSHA received
comments from Lisa Maier, MD and Margaret Mroz, MSPH from NJH during
the public comment period supporting MRP for workers with sensitization
or CBD (Document ID 1664; 1806, pp. 3-4). Specifically, Ms. Mroz
commented that "eliminating or reducing exposure can lead to
improvement in symptoms" for beryllium workers and that "[r]emoval or
reduction in exposure may prevent the development of CBD" (Document ID
1806, p. 3-4). And, during the informal public hearing, Dr. Lee Newman,
testifying on behalf of the American College of Occupational and
Environmental Medicine (ACOEM), commented that "removal from exposure
is the right thing to do for somebody who is at a stage of being
beryllium sensitized or any stage beyond that" (Document ID 1756, Tr.
143). Thus, even though CBD and sensitization are considered to be
irreversible, OSHA finds removal may still benefit sensitized employees
and those with CBD.
Finally, MRP may provide employers with an additional incentive to
keep employee exposures low. Precisely because MRP will impose
additional costs on employers, MRP can increase the protection afforded
workers by the beryllium standards not only directly by improving
medical surveillance but also indirectly by providing employers with
economic incentives to comply with other provisions of the standard.
The costs of MRP are likely to decrease as employer compliance with
other provisions of the standard increases. Employers who comply with
other provisions of the standard may have to remove relatively few
employees. With only a small number of employees requiring removal,
complying employers are more likely to be able to find positions
available to which removed employees can be transferred. By contrast,
employers who make only cursory attempts to comply with the central
provisions of these standards are likely to find that the greater their
degree of noncompliance, the greater the number of employees requiring
medical removal and the greater the associated MRP costs. Thus, as OSHA
explained in the preambles to its substance-specific standards on
Cadmium and Lead, the inclusion of MRP in a final rule can serve as a
strong stimulus for employers to protect worker health and rewards
employers who through innovation and creativity derive new ways of
protecting worker health not contemplated by these standards (57 FR
42102, 42368 (Sep. 14, 1992); 43 FR 54354, 54450 (Nov. 21, 1978)).
OSHA has the authority to include MRP in this standard. Indeed, the
Court of Appeals for the D.C. Circuit recognized the Agency's authority
to adopt such provisions more than 35 years ago in its review of the
Agency's Lead standard (Lead I, 647 F.2d at 1229-1236). There, the
Court found that MRP "appears to lie well within the general range of
OSHA's powers," and reasonable in the case of lead because it would
help prevent impermissibly high blood lead levels and mitigate
potential employee concerns about cooperating with the medical
surveillance program (Id. at 1232, 1237). And, in the three and a half
decades since the Lead I decision, OSHA has adopted MRP in five other
substance-specific health standards: Cadmium (29 CFR 1910.1027),
Benzene (29 CFR 1910.1028), Formaldehyde (29 CFR 1910.1048),
Methylenedianiline (29 CFR 1910.1050), and Methylene chloride
(1910.1052).
Paragraph (l)(1) of the proposed standard detailed the eligibility
requirements for medical removal. The provision explained that an
employee would be eligible for medical removal if he or she works in a
job with exposure at or above the action level and is diagnosed with
CBD or confirmed positive for sensitization. OSHA specifically asked
for comments on whether beryllium sensitization and CBD are appropriate
triggers for medical removal and whether there are other medical
conditions or findings that should trigger medical removal.
Stakeholders generally supported the proposed triggers. ORCHSE
Strategies (ORCHSE) argued that confirmed beryllium sensitization and
CBD are appropriate triggers for medical removal (Document ID 1691,
Attachment 1, p. 15). ORCHSE explained that since CBD is a chronic,
progressive lung disease with no known cure, it is imperative that
signs of health impairment be found early and exposure be terminated to
avoid further impairment (Document ID 1691, Attachment 1, p. 15). NJH
also commented that confirmed beryllium sensitization and CBD are
appropriate triggers for medical removal (Document ID 1664, p. 9).
Ameren, North America's Building Trades Unions (NABTU), Materion
Corporation (Materion), and USW agreed (Document ID 1675, p. 20; 1679,
p. 14; 1680, p. 7; 1681, pp. 14-15). USW commented that medical removal
could prevent the progression of disease in workers diagnosed with
sensitization or CBD (Document ID 1681, p. 15). However the Department
of Defense argued that CBD but not beryllium sensitization is an
appropriate trigger for medical removal and that sensitization is an
appropriate trigger for advising employees about risk and requiring use
of personal protective equipment if the employee chooses to return to
work (Document ID 1684, Attachment 2, p. 1-8). The American Federation
of Labor and Congress of Industrial Organizations (AFL-CIO) indicated
support for the action level exposure trigger (Document ID 1809, p. 1;
1809, Attachment 2, Tr. 930-931; 942-943).
After reviewing the record on this issue, OSHA has decided that a
CBD diagnosis and a confirmed positive test for sensitization are
appropriate triggers for medical removal. OSHA disagrees
with the DOD and concludes that sensitization is an appropriate trigger
for medical removal because removal from exposure may prevent the onset
of CBD. Therefore, OSHA is retaining the triggers of both sensitization
and CBD.
Final paragraph (l)(1), consistent with the proposal, states that
the employee is eligible for medical removal if the employee works in a
job with exposure at or above the action level, but contains more
specificity about the types of documentation that are submitted to the
employer to demonstrate eligibility for medical removal. This change
was made to track employee privacy protections included in the licensed
physician's medical opinion in paragraph (k)(6) and the CBD diagnostic
center's medical opinion in paragraph (k)(7)(iii). Under paragraphs
(k)(5) and (k)(7)(ii), the standards now specify that the licensed
physician or CBD diagnostic center provides only the employee a medical
report that contains detailed medical findings, such as confirmed
positive findings or a diagnosis of CBD. In cases where the employee is
confirmed positive or diagnosed with CBD, the physician or CBD
diagnostic center also includes recommendations for removal from
exposure in the written medical report. However, under paragraphs
(k)(6) and (k)(7)(iii), employers do not receive a written medical
opinion that contains an employee's medical information (other than any
recommended limitations on the employee's use of respirators) without
the employee's written consent. The written opinion to the employer may
contain a recommendation for removal from exposure, without the medical
reason for the recommendation, only if the employee authorizes that
recommendation to be included in the opinion. This allows an employee
who is eligible for medical removal and chooses that option to provide
official documentation requesting removal, without disclosing a
specific medical condition.
Thus, paragraph (l)(1) allows an employee's eligibility for removal
to be established by four different types of documentation:
The employee may provide a (k)(5) or (k)(7)(ii) written
medical report indicating a confirmed positive finding or diagnoses of
CBD and recommending removal because of that finding or diagnosis.
The employee may provide a (k)(5) or (k)(7)(ii) written
medical report in which the confirmed positive finding or diagnosis has
been obscured or removed, but still contains the recommendation of
removal because of that finding or diagnosis. An employee might do this
if, consistent with the approach of paragraph (k), the employee wishes
to keep the details of the condition private.
The employee may provide any reliable medical
documentation establishing a confirmed positive finding or diagnosis of
CBD, regardless of whether it was issued in compliance with paragraph
(k)(5). An employee might do this if, for example, the documentation
predates this standard. This documentation would be a "written medical
report" for purposes of (l)(1)(i)(A).
The employer receives a (k)(6) or (k)(7)(iii) written
medical opinion recommending removal from the licensed physician or CBD
diagnostic center.
OSHA added the language "in accordance with paragraph (k)(5)(v) or
(k)(7)(ii) of this standard" to (l)(1)(i)(B) and "in accordance with
paragraph (k)(6)(v) or (k)(7)(iii) of the standard" to (l)(1)(ii) to
be clear that medical removal is required under those provisions only
when the removal recommendation is based on a confirmed positive
finding or a diagnosis of CBD.
Paragraph (l)(2) of the proposal laid out the options for employees
who are eligible for MRP. Specifically, paragraph (l)(2) required
eligible employees to choose removal, as described under paragraph
(l)(3), or to remain in a job with exposure at or above the action
level as long as they wear a respirator in accordance with paragraph
(g) of this standard. While both ORCHSE and Public Citizen supported
the MRP provision, neither supported making removal optional (Document
ID 1691, Attachment 1, p. 13; 1756, Tr. 189). ORCHSE specifically
stated that utilizing respiratory protection as a means of protecting
workers violates the hierarchy of controls and removal is most prudent
for worker protection (Document ID 1691, Attachment 1, p. 13).
After careful consideration of these comments, OSHA has decided to
allow employees to choose between removal and remaining in a job with
airborne exposure at or above the action level, provided that the
employee uses respiratory protection for exposures at or above the
action level, as contemplated in the proposal. OSHA recognizes that
removal may reduce the risk of the onset of CBD and lead to reduction
of symptoms. However, CBD is unlike triggers for MRP in some other OSHA
standards, such as lead and benzene, because CBD is not reversible.
Thus, without the respirator option, mandatory removal would require
that the employee switch careers permanently. OSHA believes the worker
should be given a voice in such a fundamental life decision where the
confirmed positive employee may be able to minimize the risk of CBD
through the consistent and careful use of respiratory protection in a
workplace where feasible controls are implemented to maintain exposures
within the PEL. Indeed, mandatory permanent removal might lead workers
to hide their symptoms or not seek treatment, which is directly
contrary to the purpose of MRP. For these reasons, the Agency finds
mandating removal is not appropriate in this rulemaking. Therefore,
paragraph (l)(2) of the final standards requires employers to provide
eligible employees with the employee's choice of: (i) Removal as
described in paragraph (l)(3) of these standards; or (ii) remaining in
a job with airborne exposure at or above the action level, provided
that the employee uses respiratory protection that complies with
paragraph (g) of these standards whenever exposures are at or above the
action level.
Although paragraph (l)(2) of the final standards tracks OSHA's
intent as expressed in the proposal, the final provision contains
several clarifying changes. First, final paragraph (l)(2) explicitly
places the responsibility for providing the choices on the employer,
while the proposal merely implied that the employer would do so. OSHA
believes that this clarification eliminates the possibility of
confusion. Second, final paragraph (l)(2)(ii) refers to paragraph (g)
of these standards, instead of referring to the Respiratory Protection
standard (29 CFR 1910.134). OSHA made this second change to bring this
provision into line with a similar provision in paragraph (e) of the
final standards; it does not affect the employer's obligations as set
forth in the proposed rule. Third, final paragraph (l)(2)(ii) expressly
requires employers to ensure that employees use the respiratory
protection whenever airborne exposures meet or exceed the action level.
Again, this requirement was implied in the proposal, but OSHA believes
that making the requirement express helps employers understand their
obligations under these standards.
Proposed paragraph (l)(3) contained requirements that would have
applied if an eligible employee elected removal. Under the proposal,
when an employee chooses removal, the employer would have been required
to remove the employee to comparable work if such work was available.
Proposed paragraph (l)(3)(i) explained that comparable work is a
position for which the employee is already qualified or can be trained
within one month, in an environment where beryllium exposure is below
the action level. As explained in the preamble to the proposal, this
provision would not have required an employer to place an employee on
paid leave under proposed paragraph (l)(3)(iii) if the employee refused
comparable work offered under paragraph (l)(3)(i).
If comparable work was not immediately available, paragraph
(l)(3)(ii) of the proposal would have required the employer to place
the employee on paid leave for six months or until comparable work
becomes available, whichever occurs first. Proposed paragraph
(l)(3)(ii) further explained that if comparable work became available
before the end of the six month paid leave period, the employer would
have been obligated to offer the open position to the employee.
However, OSHA explained that if the employee declined the position, the
employer would have had no further obligation to provide paid leave.
Proposed paragraph (l)(3)(iii) would have continued a removed
employee's rights and benefits for six months, regardless of whether
the employee was removed to comparable work or placed on paid leave.
The six-month period would have begun when the employee was removed,
which means either the day the employer transferred the employee to
comparable work, or the day the employer placed the employee on paid
leave. For this period, the provision would have required the employer
to maintain the employee's base earnings, seniority, and other rights
and benefits of employment as they existed at the time of removal. OSHA
explained that this provision is typical of medical removal provisions
in other OSHA standards, such as Cadmium (29 CFR 1910.1027), Benzene
(29 CFR 1910.1028), Formaldehyde (29 CFR 1910.1048), Methylenedianiline
(29 CFR 1910.1050), and Methylene Chloride (29 CFR 1910.1052).
As detailed above, there is widespread support among stakeholders
for the inclusion of removal and wage protection for eligible employees
in this rulemaking. The provisions included in the proposal were
consistent with the recommendation of beryllium health specialists in
the medical community and with the draft recommended standard provided
by Materion and USW (Document ID 0754). However, not all commenters
agreed with the proposed provisions. One commenter, NABTU, argued that
"[i]f an employer who has placed an employee at risk cannot offer
alternative employment [within six months], then a better solution
would be to provide MRP until the employee has obtained new and
equivalent employment, provided that the employee is making a good
faith effort at finding new employment [emphasis added]." (Document ID
1679, p. 15).
OSHA is sympathetic to NABTU's position--some employers, especially
small employers, may lack the flexibility and resources to provide
comparable positions for MRP-eligible employees (Document ID 0345, p.
24), and as a result, employees' base earnings and benefits would only
be maintained for a six-month period. However, OSHA also recognizes
that the requirement to maintain the employee's base earnings,
seniority, and other rights and benefits that existed at the time of
removal for even a six-month period may be difficult for some
employers. After weighing these two concerns, OSHA finds that the
requirement to provide medical removal protection for a six-month
period strikes a reasonable balance between protecting employees and
limiting the burden on employers. Therefore, OSHA has decided to retain
these provisions in the final standard with minor edits, as follows.
First, OSHA reorganized and edited paragraph (l)(3)(i) to clarify
and emphasize the employer's responsibilities. Like the proposed
provision, final paragraph (l)(3) applies where an eligible employee
chooses removal. If a comparable job is available where exposures to
beryllium are below the action level, and the employee is qualified for
that job or can be trained within one month, final paragraph (l)(3)(i)
requires the employer to remove the employee to that job. Although each
of these requirements was expressly stated in the NPRM in either the
regulatory text or the preamble (80 FR 47802), OSHA has chosen to make
its intent express in the final regulatory text. For example, the NPRM
implied in regulatory text and explained in the preamble that an
employer's obligation under proposed paragraph (l)(3)(i) arose where
comparable work was available, but the final text makes the trigger for
this obligation explicit (see 80 FR 47802; proposed paragraph
(l)(3)(ii) (which applied "if comparable work is not available)).
Second, OSHA omitted the proposed requirement in paragraph
(l)(3)(i) that "[t]he employee must accept comparable work if such
work is available" from final paragraph (l)(3)(i). As stated in the
preamble to the proposal, OSHA included this statement in proposed
paragraph (l)(3)(i), in part, to make clear that if the employee
declines an offer of comparable work, then the employer was not
obligated to place the employee on paid leave under paragraph
(l)(3)(ii) (80 FR 47802). However, because OSHA regulates employers,
this requirement is better expressed as a clarification to the
employer's responsibilities. OSHA concludes that the opening clause to
proposed and final paragraphs (l)(3)(ii), which indicates that an
employer's obligation to maintain the employee's base earnings,
seniority, and other rights and benefits that existed at the time of
removal arises "[i]f comparable work is not available" makes this
sufficiently clear.
Third, OSHA eliminated proposed paragraphs (l)(3)(iii), which
stated that "whether the employee is removed to comparable work or
placed on paid leave, the employer shall maintain for 6 months the
employee's base earnings, seniority, and other rights and benefits that
existed at the time of removal." In the final rule, proposed
(l)(3)(iii)'s requirements have been incorporated into final paragraphs
(l)(3)(i) and (ii). OSHA believes that this simplification will clarify
the Agency's intent.
OSHA has also omitted the phrase "paid leave" from final
paragraph (l)(3)(ii) because, with the incorporation of proposed
paragraph (l)(3)(iii)'s temporal and benefits requirements into final
paragraph (l)(3)(ii), it is unnecessary to specify what an employee who
has been removed but is not working in a comparable job would be doing.
In addition, OSHA wishes to give employers the flexibility to work with
removed employees to create alternatives to merely placing the employee
on paid leave. For example, employers might choose to offer the
employee the opportunity to train for more than one month so that he or
she could qualify for a different job. Provided that the employer
otherwise complied with final paragraph (l)(3)(ii), such an arrangement
would be permissible under the final standards.
Finally, proposed paragraph (l)(4) provided that an employer's
obligation to provide MRP benefits to a removed employee would be
reduced if, and to the extent that, the employee receives compensation
from a publicly or employer-funded compensation program for earnings
lost during the removal period, or receives income from another
employer made possible by virtue of the employee's removal. OSHA
retained this requirement unchanged in final paragraph (l)(4). OSHA
clarifies that benefits received under the Energy Employees
Occupational Illness Compensation Program Act (EEOICPA) do not
constitute wage replacement; therefore, EEOICPA benefits would not
offset the employee's MRP benefits.
OSHA did not receive any comments specifically directed to this
provision, but, as noted above, several stakeholders commented that
they supported the MRP provisions contained in the proposal as a whole
(i.e., Document ID 1664, pp. 3-4, 9; 1680, pp. 1, 7; 1681, pp. 14-15;
1683, p. 3; 1688, p. 2; 1689, pp. 8, 13-14; 1690, pp. 1, 3-4; 1691,
Attachment 1, pp. 13, 15; 1755, Tr. 26, 168; 1756, Tr. 142-143; 1809,
p. 1; 1963, pp. 13-14). After considering all comments and the record
as a whole on MRP, OSHA finds that a provision for MRP is a necessary
part of the final rule. As discussed above, MRP protects an employee's
rights and benefits during the first six months of removal, and OSHA
structured the MRP provisions to provide for ways to reduce in certain
circumstances an employer's obligation to compensate employees for
earnings lost. OSHA emphasizes, however, that MRP is not intended to
serve as a workers' compensation system. The primary reason the Agency
is including MRP in this standard is to provide eligible employees a
six-month period to adjust to the comparable work arrangement or to
seek alternative employment, without any further exposure at or above
the action level. The Agency finds that this provision accomplishes
that goal while providing for allowing the employer to control costs in
many cases. In addition, this provision is consistent with other
standards such as Formaldehyde (29 CFR 1910.1048), Methylenedianiline
(29 CFR 1910.1050), and Methylene Chloride (29 CFR 1910.1052).
For the reasons discussed above, OSHA finds that maintaining the
MRP provision, with the clarifying changes noted above, in the final
rule provides workers the incentive to participate in the medical
surveillance program and provides workers with sensitization or CBD the
opportunity and means to minimize further exposure to beryllium.
(m) Communication of Hazards
Paragraph (m) of the standards for general industry, construction,
and shipyards sets forth the employer's obligations to comply with
OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200) relative
to beryllium, and to take additional steps to warn and train employees
about the hazards of beryllium. Employees need to know about the
hazards to which they are exposed, along with the associated protective
measures, in order to understand how they can minimize potential health
hazards. As part of an overall hazard communication program, training
serves to explain and reinforce the information presented on labels and
safety data sheets (SDSs). These written forms of communication will be
most effective when employees understand the information presented and
are aware of how to avoid or minimize exposures, thereby reducing the
possibility of experiencing adverse health effects. Several commenters,
including Ameren Corporation (Ameren) and United Steelworkers (USW),
generally supported inclusion of a hazard communication requirement in
the beryllium standards (e.g., Document ID 1675, p. 7; 1681, p. 15).
As a general matter, the HCS requires a comprehensive hazard
evaluation and communication process, aimed at ensuring that the
hazards of all chemicals are evaluated, and also requires that the
information concerning chemical hazards and necessary protective
measures is properly transmitted to employees. The HCS achieves this
goal, in part, by requiring chemical manufacturers and importers to
review available scientific evidence concerning the physical and health
hazards of the chemicals they produce or import to determine if they
are hazardous. For every chemical found to be hazardous, the chemical
manufacturer or importer must develop a container label and an SDS, and
provide both documents to downstream users of the chemical. All
employers with employees exposed to hazardous chemicals must develop a
hazard communication program and ensure that all containers of
hazardous chemicals are labeled and employees are provided access to
SDSs and are trained on the hazardous chemicals in their workplace.
Because OSHA preliminarily found beryllium to be a hazardous chemical,
the Agency determined that hazard communications provisions should be
included in the proposal. OSHA intends for the hazard communication
requirements in the final standards to be substantively as consistent
as possible with the HCS, while including additional specific
requirements needed to protect employees exposed to beryllium, in order
to avoid duplicative administrative burden on employers who must comply
with both the HCS and this rule. Proposed paragraph (m)(1)(i) required
chemical manufacturers, importers, distributors, and employers to
comply with all applicable requirements of the HCS (29 CFR 1910.1200)
for beryllium. Stakeholders did not offer any comments on this
provision. After reviewing the full record, including all available
evidence, and as discussed in this preamble at Section V, Health
Effects, and Section VI, Risk Assessment, OSHA finds that beryllium is
a hazardous chemical for purposes of the HCS. Therefore, the Agency
includes paragraph (m)(1)(i) of the final standards for general
industry, construction, and shipyards to require chemical
manufacturers, importers, distributors, and employers to comply with
their duties under HCS. The final provision in these standards is
substantively unchanged from the proposed provision. Paragraph
(m)(1)(ii) of the proposal required employers to address at least the
following, in classifying the hazards of beryllium: Cancer; lung
effects (chronic beryllium disease and acute beryllium disease);
beryllium sensitization; skin sensitization; and skin, eye, and
respiratory tract irritation. According to the HCS, employers must
classify hazards if they do not rely on the classifications of chemical
manufacturers, importers, and distributors (see 29 CFR
1910.1200(d)(1)). Commenters did not object to this provision.
Therefore, after considering the record, including the general comments
in favor of the proposed hazard communications provisions and the
evidence presented in Section V, Health Effects, and Section VI, Risk
Assessment, regarding the enumerated hazards of exposure to beryllium,
OSHA has decided to retain this proposed provision substantively
unchanged in final paragraph (m)(1)(ii) of the standards for general
industry and shipyards. However, OSHA has revised the language to bring
it into conformity with other substance specific standards so it is
clear that chemical manufacturers, importers, and distributors are
among the entities required to classify the hazards of beryllium (See
77 FR 17748-50).
OSHA has chosen not to include an equivalent requirement in the
final standards for construction and shipyards since employers in
construction and shipyards are downstream users of beryllium products
(blasting media) and would not therefore be classifying chemicals
(Chapter IV of the Final Economic Analysis).
Proposed paragraph (m)(1)(iii) required employers to include
beryllium in the hazard communication program established to comply
with the HCS, and ensure that each employee has access to labels on
containers and safety data sheets for beryllium and is trained in
accordance with the HCS and paragraph (m)(4) of this section.
Stakeholders did not object to any part of this provision. After
reviewing the record, OSHA reaffirms that employees
exposed to beryllium need additional training and information.
Therefore, OSHA has decided to include the approach set forth in the
proposed rule in the final paragraph (m)(1)(iii) of the final standards
for general industry and shipyards and final paragraph (m)(1)(ii) of
the standard for construction. The final provisions are substantively
unchanged from the proposal.
Paragraph (m)(2)(i) of the proposed standard required employers to
provide and display warning signs at each approach to a regulated area
so that each employee is able to read and understand the signs and take
necessary protective steps before entering the area. Proposed paragraph
(m)(2)(ii) of the standards required employers to ensure that warning
signs are legible and readily visible, and that they bear the following
legend:
DANGER
BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING AND EQUIPMENT IN
THIS AREA
A number of stakeholders offered opinions on these provisions. Some
stakeholders, like the USW, supported the proposed provisions (e.g.,
Document ID 1681, p. 15). Other stakeholders offered specific critiques
regarding the proposed required language for the signs. For example,
NGK Metals Corporation (NGK) and Materion Corporation (Materion)
strongly opposed having cancer warnings displayed on warning signs.
These commenters requested that OSHA strike out the cancer warning
based on the results of a recent study by Boffetta, et al. (2014)
(Document ID 0403) that does not show an elevated risk of cancer to
workers exposed to beryllium (Document ID 1663, p. 3; 0403; 1958, pp.
3-5). Materion added that the cancer warning masks the true risk, CBD,
and that the wording on warning signs should be changed to "Causes
Damage to Lungs" to reflect the true hazard (Document ID 1958, pp. 4-
5).
OSHA has decided to retain the hazard statement about cancer as a
requirement for the warning signs. As discussed in this preamble at
Section V, Health Effects, and Section VI, Risk Assessment, OSHA has
reviewed the scientific literature for beryllium carcinogenicity,
including the Boffeta study, and has concluded that beryllium is
carcinogenic. The Agency's finding is based on the best available
epidemiological data, reflects evidence from animal and mechanistic
research, and is consistent with the conclusions of other government
and public health organizations. Furthermore, the International Agency
for Research on Cancer (IARC), National Toxicology Program (NTP), and
American Conference of Governmental Industrial Hygienists (ACGIH) have
all classified beryllium as a known human carcinogen (Document ID 0651;
0389, pp. 1-3; 1304; 0345, p. 4). In light of this evidence, OSHA finds
the comments opposing the cancer warning language on signs
unpersuasive. However, with regard to Materion's suggested language,
OSHA agrees that a warning that beryllium can cause damage to lungs is
appropriate and retains that language, as proposed, in the final
standards for general industry and shipyards.
A few other stakeholders also suggested edits or additions to the
proposed sign legend. For example, NGK recommended that the phrase,
WEAR RESPIRATORY PROTECTION AND PROTECTIVE EQUIPMENT IN THIS AREA be
changed to WEAR RESPIRATORY PROTECTION AND PROTECTIVE EQUIPMENT PRIOR
TO ENTERING THIS AREA, on warning signs to emphasize that personal
protective equipment (PPE) must be put on before entering the
restricted work area (Document ID 1663, p. 3). OSHA agrees that
employees need to don PPE prior to entering the regulated area, but
finds the suggested language requiring respiratory protection and PPE
"in this area" is sufficient to alert the workers to put their
equipment and respirators on prior to entering the restricted work
area. Therefore, OSHA has decided to retain the text "in this area"
as stated in the final standards for general industry and shipyards.
OSHA also notes that this language is consistent with the HCS and other
previous health standards, such as Benzene (29 CFR 1910.1028).
One stakeholder proposed a provision particular to shipyards. In
hearing testimony, Ashlee Fitch of USW commented that warning signs
"demarking abrasive blasting operations with beryllium-containing
materials" should be posted (Document ID 1756, p. 245). OSHA has
chosen not to incorporate this suggestion. The signs required by
paragraph (m)(2) of this final rule are intended to serve as a warning
to employees and others who may not be aware that they are entering a
regulated area, and to remind them of the hazards of beryllium so that
they take necessary protective steps before entering the area. These
signs are also intended to supplement the training that employees must
receive regarding the hazards of beryllium, since even trained
employees need to be reminded of the locations of regulated areas and
of the precautions necessary before entering these dangerous areas (see
paragraph (m)(4) of this rule and 29 CFR 1910.1200(h) for training
requirements). OSHA does not believe it is necessary for the signs to
denote the precise activity occurring within the regulated area in
order to accomplish these goals. However, employers may choose to
include additional information on the signs required under this rule,
provided that the additional information included is not confusing or
misleading and does not detract from required warnings.
Thus, paragraph (m)(2)(i)) of the final standards for general
industry and shipyards requires employers to provide and display
warning signs at each approach to a regulated area so that each
employee is able to read and understand the signs and take necessary
protective steps before entering the area. Pursuant to final paragraph
(m)(2)(ii), employers must ensure that these warning signs legible and
readily visible and include the specified legend. The only alteration
to the legend from the proposal is the addition of the words,
"REGULATED AREA" following the word, "DANGER." OSHA has not
included these regulated area signage requirements in the final
standard for construction, because the construction standard does not
contain requirements for establishing regulated area and uses the
competent person (paragraph (e) of the construction standard) to limit
access to areas where exposures have the potential to be above the PEL.
In summary, OSHA finds that the use of warning signs is important to
make employees who are regularly scheduled to work at these sites aware
of beryllium hazards, to alert employees who have limited access to
these sites of beryllium hazards, and to warn those who do not require
access to regulated areas to avoid those areas. Access must be limited
to authorized personnel to ensure that those entering the area are
adequately trained and equipped, and to limit exposure to those whose
presence is absolutely necessary. By limiting access to authorized
persons, employers can minimize employee exposure to beryllium in
regulated areas and thereby minimize the number of employees who may
require medical surveillance or may be subject to the other
requirements associated with working in a regulated area.
Proposed paragraph (m)(3) required that labels be affixed to all
bags and containers of clothing, equipment, and materials visibly
contaminated with beryllium. OSHA also included a requirement that the
labels contain the following statement:
DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN
The USW supported the proposal's requirement that bags and
containers storing materials visibly contaminated with beryllium have
specific warning labels to alert workers of the dangers of beryllium
exposure (Document ID 1681, p. 15). However, as discussed in the
Summary and Explanation on paragraph (h) on personal protective
clothing and equipment, several commenters objected to the use of the
term "visibly contaminated." For example, the Non-Ferrous Founder's
Society (NFFS) commented that the definition of "visibly contaminated
with beryllium" was not provided in the proposed rule and was vague
(Document ID 1679, p. 5). OSHA agrees that the term is ambiguous and
has chosen to remove the term visibly from the final standards. OSHA
has therefore relied on terminology that is commonly used in other
substance specific standards for metals, such as Chromium (VI) (29 CFR
1910.1026). NGK also recommended that OSHA insert the word
"particulate" (Document ID 1663, pp. 3-4). OSHA declines to adopt
this suggestion. The addition of the term "particulate" is
unnecessary and may cause confusion since the final standards cover
beryllium in all forms, compounds, and mixtures. Several stakeholders
also weighed in on other aspects of these provisions. For example, NGK
and Materion offered comments on the proposed wording of the required
labels, which restated their requests that the cancer warnings be
struck from the proposed language (Document ID 1663, pp. 3-4; 1958, pp.
3-5). OSHA has decided to retain the cancer warning labeling
requirements in the final rule for the reasons discussed in response to
their comments on paragraph (m)(2) above.
ORCHSE Strategies (ORCHSE) also commented on the labeling
requirements of containers and bags in paragraph (m)(3). First, it
argued that the provision would require the precautionary statements
"Avoid creating dust" and "Do not get on skin" for all bags and
containers which it maintained is inconsistent with the HCS
precautionary statements (Document ID 1691, Attachment 1, p. 23). OSHA
acknowledges that these "precautionary statements" are not from
Appendix C of the HCS. However, OSHA is requiring alternate language
for the unique situation for bags of contaminated clothing or equipment
where workers handling these materials may not have access to other
more in-depth forms of information. The Agency is therefore requiring
that employers place appropriate warning language on bags and
containers containing beryllium-contaminated materials. This provision
is consistent with other substance-specific health standards.
Second, ORSCHSE argued that the proposed labeling requirements are
inconsistent with the HCS. It stated that paragraph (m)(1) required
compliance with the HCS, which covers warning labels for hazardous
chemicals other than beryllium, "so using the same standard for
beryllium labels would promote consistency throughout the workplace."
Therefore, it suggested that paragraph (m)(3) be deleted, because
paragraph (m)(1) already requires observation of "all requirements"
of the HCS. Additionally, ORCHSE commented that the HCS does not
require labeling for carcinogens on bags and containers unless the
concentration is 1% or more (Document ID 1691, Attachment 1, pp. 23-
24).
After considering these comments and the record on this issue, OSHA
has decided to retain proposed paragraph (m)(3) with the minor
alteration described above. The final provision, which appears in
paragraph (m)(3) of the final standards for general industry and
shipyards and paragraph (m)(2) of the final standard for construction,
requires employers to label each bag and container of clothing,
equipment, and materials contaminated with beryllium. The required
label must, at a minimum, include the language specified in the
proposal. The warning label language for the signal word (danger) and
hazard statements (may cause cancer) are consistent with the GHS.
However, OSHA has decided that the precautionary statements needed to
be slightly different due to the nature of the exposure and the fact
that sensitization can result from short term exposures (see Health
Effects section V of this preamble).
While ORCHSE correctly notes that the HCS contains a concentration
cutoff (0.1% for category 1 carcinogens, and 1% for category 2
carcinogens), that cutoff is difficult to apply in the case of clothing
or other material that has been contaminated with beryllium-containing
dust. As a practical matter, it may be difficult to determine whether
the cutoffs have been exceeded with dust contamination. Moreover, the
cutoffs were developed for mixtures that are products and more
homogeneous in nature, rather than materials contaminated with dust. If
contaminated clothing or other materials are handled in a way that
generates dust, exposures of concern might occur more readily than with
homogenous mixtures of similar concentration. OSHA believes the clearer
approach is to require all contaminated materials with a uniform
labelling scheme, as it has for other substance-specific standards
(e.g., Lead, 29 CFR 1910.1025; Cadmium, 29 CFR 1910.1027; Coke Oven
Emissions, 29 CFR 1910.1029). Including this provision will ensure that
downstream workers who might receive the contaminated material have
notice of the contamination. As discussed in the summary and
explanation for paragraph (b) the term "materials" includes waste,
scrap, debris, and any other items contaminated with beryllium.
The Agency finds that the final labeling requirements will help
ensure that all affected employees, not only the employees of a
particular employer, are apprised of the presence of beryllium-
containing materials and the hazardous nature of beryllium exposure.
With this knowledge, employees can take steps to protect themselves
through proper work practices established by their employers. Employees
are also better able to alert their employers if they believe exposures
or skin contamination can occur.
Proposed paragraph (m)(4) contained requirements for employee
information and training. The proposed provisions applied to each
employee who is or can reasonably be expected to be exposed to airborne
beryllium. ORCHSE strongly urged OSHA to rewrite this provision to
align with the HCS training, arguing that "there is no need to include
chemical hazard training requirements in a substance specific
standard" (Document ID 1691, Attachment 1, p. 20). While OSHA agrees
that the HCS is designed to cover all chemical hazards in the
workplace, an employer may choose to train by specific chemical or by
hazard. In this substance specific standard, OSHA find that employees
need to be trained on the hazards specifically associated with
beryllium, in addition to the training they receive under the HCS.
These types of requirements are not uncommon in substance specific
hazards. For example, the Lead standard requires annual training on the
specific hazards associated with lead exposure (see 29 CFR 1910.1025
(l)(1)). Consequently, OSHA is not persuaded by ORCHSE that OSHA should
substantially change the training provisions in the final rule.
The Boeing Company (Boeing) suggested that OSHA add the text
"within the scope of this standard" to the end of this requirement
(Document ID 1667, p. 7). It contended that its
recommended language would "set a measurable boundary consistent with
the scope of the standard," while the proposal would create an "open
ended boundary that would confuse compliance efforts." OSHA has
considered the suggestion but does not find Boeing's argument
persuasive. OSHA does not believe this adds additional clarity to
employer on which employees should be trained. OSHA expects that once
the employer is covered under the standard they are in the best
position to determine who would be potentially exposed to beryllium.
Additionally, this language is consistent with other substance specific
standards, such as Benzene (29 CFR 1910.1028).
NGK also commented on the proposed trigger. Specifically, it
suggested the training requirements should be consistent with the lead
standard (29 CFR 1910.1025(l)(1)(ii)) in that the training should be
done for those workers exposed above the action level (Document ID
1663, p. 4). OSHA declines to adopt this suggestion. As discussed in
Section V, Health Effects, and Section VI, Risk Assessment, risk of
material impairment to health remains at exposure levels below the
action level. Because of this risk, OSHA concludes that it is necessary
and appropriate to train all employees who may be exposed to airborne
beryllium at any level. The Agency finds that all such employees will
benefit from this training. Therefore, OSHA is continuing to trigger
the training requirements proposed in paragraph (m)(4)(i) based on
airborne exposure, or anticipated exposure, at any level. The final
provisions are contained in paragraph (m)(4)(i) of the standards for
general industry and shipyards and paragraph (m)(3)(i) of the standard
for construction.
Proposed paragraph (m)(4)(i)(A) required employers to provide
employees who are or can reasonably be expected to be exposed to
airborne beryllium with information and training in accordance with the
requirements of the HCS (29 CFR 1910.1200(h)), including specific
information on beryllium as well as any other hazards addressed in the
workplace hazard communication program.
OSHA did not receive any objections to or comments on this
provision. After a review of the rulemaking record, the Agency
continues to believe that the provision of information and training in
accordance with the HCS will benefit employees. For example, under the
HCS, employers must provide their employees with information such as
the location and availability of the written hazard communication
program, including lists of hazardous chemicals and safety data sheets,
and the location of operations in their work areas where hazardous
chemicals are present. The HCS also requires employers to train their
employees on ways to detect the presence or release of hazardous
chemicals in the work area, such as any monitoring conducted, the
physical and health hazards of the chemicals in the work area, measures
employees can take to protect themselves, and the details of the
employer's hazard communication program (29 CFR 1910.1200(h)(3)).
Therefore, OSHA has included proposed paragraph (m)(4)(i)(A)
substantively unchanged from the proposal in paragraph (m)(4)(i)(A) of
the final standards for general industry and shipyards and paragraph
(m)(3)(i)(A) of the final standard for construction.
Proposed paragraphs (m)(4)(i)(B) and (C) specified when an
employer's obligation to train covered employees should begin and how
often training should occur. Proposed paragraph (m)(4)(i)(B) required
initial training by the time of initial assignment, which means before
the employee's first day of work in a job that could reasonably be
expected to involve exposure to airborne beryllium. Under proposed
paragraph (m)(4)(i)(C), employers were required to repeat training at
least annually thereafter. USW supported the requirement of initial and
annual training for workers who are or can be reasonably expected to be
exposed to beryllium (Document ID 1681, p. 15).
After reviewing the record on this topic, OSHA has decided to
retain proposed paragraphs (m)(4)(i)(B) and (m)(4)(i)(C) in paragraph
(m)(4)(i)(B) and (C) of the final standards for general industry and
shipyards and paragraph (m)(3)(i)(B) and (C) of the final standard for
construction. OSHA finds that initial training and annual retraining
are necessary due to the serious and debilitating health effects of
beryllium exposure, and for reinforcement of employees' knowledge of
those hazards. The initial training requirement is consistent with the
HCS, which requires that employers provide employees with effective
information and training on hazardous chemicals in their work area at
the time of their initial assignment (29 CFR 1910.1200(h)(1)). In
addition, while the triggers may be slightly different, the initial and
annual training requirement are consistent with other OSHA standards
such as those for Lead (29 CFR 1910.1025), Cadmium (29 CFR 1910.1027),
Benzene (29 CFR 1910.1028), Coke Oven emissions (29 CFR 1910.1029),
Cotton Dust (29 CFR 1910.1043), and 1,3-Butadiene (29 CFR 1910.1051).
Proposed paragraph (m)(4)(ii) required the employer to ensure that
each employee who is or can reasonably be expected to be exposed to
airborne beryllium can demonstrate knowledge of nine enumerated
categories of information. ORCHSE and NGK objected to this proposed
requirement. ORCHSE suggested that OSHA replace "can demonstrate
knowledge of" with "has been informed of" in paragraph (m)(4)(ii).
ORCHSE also argued that employers can control what information they
provide, but cannot control what information the employee retains, and
a literal interpretation of the requirement that employees must
"demonstrate knowledge of" the nine enumerated categories of
information will result in citations whenever "any employee, at any
moment, is unable to recite detail" on those topics (Document ID 1691,
Attachment 1, pp. 21-23). Similarly, NGK commented that the requirement
that employers must ensure that employees who may be exposed to
beryllium can demonstrate knowledge of enumerated subjects should be
replaced with a requirement that employers ensure employee
participation in a training program, consistent with the lead standard
(29 CFR 1910.1025(l)(1)(ii)) (Document ID 1663, p. 4).
OSHA does not find these arguments persuasive. Because beryllium is
a hazardous chemical with serious and debilitating health effects, it
is imperative that employers can ensure that employees can demonstrate
that they understand the material and have knowledge of the topics
covered during the training sessions, as previously indicated. To
adjust the text to read "has been informed of" or to require the
employer to ensure employee participation in training will not ensure
employee comprehension and consequently could lead to employees not
understanding the health effects associated with beryllium exposure and
safety concerns to protect themselves from exposure. This language
would also be inconsistent with the HCS, which requires effective
training which OSHA indicates must be in a manner which an employee
comprehends.
The Agency understands that employers would like more clarity on
how to determine whether training requirements are met. However, OSHA
has decided that the training requirements under the final beryllium
standards, like those in HCS, are best accomplished when they are
performance-oriented. But, as in past
standards, the Agency does offer some suggestions.
First, although OSHA finds that the employer is in the best
position to determine how the training can most effectively be
accomplished, the Agency notes that hands-on training, videotapes, DVD
or slide presentations, classroom instruction, informal discussions
during safety meetings, written materials, or any combination of these
methods may be appropriate. Second, to ensure that employees comprehend
the material presented during training, it is critical that trainees
have the opportunity to ask questions and receive answers if they do
not fully understand the material that is presented to them. When
videotape presentations or computer-based programs are used, this
requirement may be met by having a qualified trainer available to
address questions after the presentation, or providing a telephone
hotline so that trainees will have direct access to a qualified
trainer. Although it is important that employees be able to ask
questions, OSHA finds that the employer is in the best position to
determine whether the instructor must be available for questions during
training or if an instructor or trainer can answer questions after the
training session. Such performance-oriented requirements are intended
to encourage employers to tailor training to the needs of their
workplaces, thereby resulting in the most effective training program
for each workplace.
Third, in addition to being performance-oriented, these training
requirements are also results-oriented. As discussed in the respirable
crystalline silica standard, there are a variety of methods employers
can use to determine whether employees have the requisite knowledge.
For example, employers may choose to facilitate discussions of the
required training subjects or administer written tests or oral quizzes.
Any of these methods could alert an employer to an employee knowledge
gap.
Finally, OSHA has included a modification in the final standards
that was prompted by ORCHSE and NGK's questions. In the final standards
(paragraph (m)(4)(ii) of the standards for general industry and
shipyards and paragraph (m)(3)(ii) of the standard for construction),
OSHA requires that the employer must ensure that employees demonstrate
understanding, in addition to knowledge. As discussed above this is
consistent with the HCS and emphasizes that it is not enough for an
employee to simply be provided with the information; the employer must
also ensure that the employee understands the topics on which he or she
is trained.
This change is consistent with Assistant Secretary David Michaels'
memorandum to OSHA Regional Administrators (Document ID 1754, p. 2).
The memorandum explains that because employees have varying educational
levels, literacy, and language skills, training must be presented in a
language, or languages, and at a level of understanding that accounts
for these differences in order to ensure that employees understand the
training. As stated by Assistant Secretary Michaels:
[A]n employer must instruct its employees using both a language
and vocabulary that the employees can understand. For example, if an
employee does not speak or comprehend English, instruction must be
provided in a language that the employee can understand. Similarly,
if the employee's vocabulary is limited, the training must account
for that limitation. By the same token, if employees are not
literate, telling them to read training materials will not satisfy
the employer's training obligation (Document ID 1754, p. 2).
This may mean, for example, providing materials, instruction, or
assistance in Spanish rather than or in addition to English if some of
the employees being trained are Spanish-speaking and do not understand
English. However, the employer is not required to provide training in
the employee's preferred language if the employee understands the
language used for training.
Finally, Boeing suggested that OSHA add the text "or equally as
effective documentation" to paragraph (m)(4)(ii)(B), so that the
employer could satisfy its obligations by ensuring that employees who
are or can reasonably be expected to be exposed to airborne beryllium
could demonstrate knowledge of "[t]he written exposure control plan,
or equally as effective documentation, with emphasis on the location(s)
of beryllium work areas, including any regulated areas, and the
specific nature of operations that could result in employee exposure,
especially employee exposure above the TWA PEL or STEL." They contend
that this added language would allow employers "to provide the
required information through the use of existing processes instead of
through the creation of a second redundant document" (Document ID
1667, p. 7).
OSHA has considered Boeing's suggestion but does not find its
arguments persuasive. Paragraph (m)(4)(ii)(B) of the final standards
specifically requires the employer to ensure that employees can
demonstrate understanding and knowledge of the topics covered in the
written control plan, not from a similar document. The suggested
language makes it unclear whether the employee would get the
appropriate training needed and still gain the same knowledge and
understanding required by the beryllium standard. OSHA, therefore, has
decided to retain paragraph (m)(4)(ii)(B)'s requirements from the
proposed rule in these final standards. That said, employers are free
to incorporate their current exposure control program into the written
control program required by paragraph (f)(1) if their program meets the
requirements of that paragraph. If they do so, and train their
employees on that program, paragraph (m)(4)(ii)(B) requires no "second
redundant document."
Proposed paragraph (m)(4)(ii)(A)-(I) specified the contents of
training for employees who are or can reasonably be expected to be
exposed to airborne beryllium. The proposed list required employers to
ensure that employees can demonstrate knowledge of: (1) The health
hazards associated with exposure to soluble beryllium compounds,
including the signs and symptoms of CBD; (2) the written exposure
control plan, with emphasis on the location(s) of beryllium work areas,
including any regulated areas, and the specific nature operations that
could result in employee exposure, especially employee exposure above
the TWA PEL or STEL; (3) the purpose, proper selection, fitting, proper
use, and limitations of personal protective clothing and equipment,
including respirators; (4) applicable emergency procedures; (5)
measures employees can take to protect themselves from exposure to
beryllium and contact with soluble beryllium compounds, including
personal hygiene practices; (6) the purpose and a description of the
medical surveillance program required by paragraph (k) of this
standard, including risks and benefits of each test to be offered; (7)
the purpose and a description of the medical removal protection
provided under paragraph (l) of this standard; (8) the contents of this
standard; and (9) the employee's right of access to records under the
Records Access Standard (29 CFR 1910.1020).
Stakeholders offered several comments on these proposed training
topics. For example, ORCHSE commented that the employer should just
"provide information and training as specified in the HCS" (Document
1691, Attachment 1, p. 23). OSHA has chosen not to adopt this
suggestion because it finds that employees need training specific to
beryllium and its hazards, not only the general training
required by the HCS on the hazards in the workplace. The Agency
concludes that providing information and training on the topics
proposed is essential to ensuring that employees are informed about the
hazards attributed to beryllium exposures, the measures necessary to
protect themselves, and the rights accorded to them under these
standards.
Stakeholder comments support OSHA's finding that training will lead
to better work practices and hazard avoidance. For example, in hearing
testimony, Chris Trahan from North America's Building Trades Unions
(NABTU) commented that in construction, she does not "see a high level
of awareness about hazards related to beryllium" (Document ID 1756,
pp. 207-08). NABTU also commented that it "developed a survey to
determine the level of awareness of beryllium hazards and knowledge of
exposures among building trades trainers," and found widespread
ignorance of beryllium health risks even among survey respondents
responsible for delivering hazard awareness training (Document ID 1679
p. 5). Ashlee Fitch from the USW testified that in her experience in
abrasive blasting, there was no training specific to what the material
contained, and "the health effects associated with . . . blasting
media" were not discussed (Document ID 1756, p. 247). Thus, OSHA
concludes that mandating information and training on the topics
specific to beryllium as outlined in proposed paragraph (m)(4)(ii) is
particularly important.
In light of these comments, OSHA reaffirms its finding that all
nine of the training topics listed in proposed paragraph (m)(4)(ii)(A)-
(I) should be included in the final standards. The Agency has thus
retained these topics in final paragraphs (m)(4)(ii)(A)-(I) of the
standards for general industry and shipyards and paragraph
(m)(3)(ii)(A)-(I) of the standard for construction, with minor
alterations for consistency with triggers that were updated from the
proposal to the final. For example, OSHA has changed the (m)(4)(ii)(A)
from "contact with soluble beryllium" to "contact with beryllium."
OSHA is not mandating additional training for a competent person in
paragraph (m) of the standards for construction. As discussed in more
detail in the summary and explanation of Written Exposure Control Plan,
the knowledge required by an individual implementing the written
exposure control plan required by these standards already ensure a high
level of competence. OSHA recognizes that there may be situations in
which an employee needs additional training in order to ensure that he
or she has the knowledge, skill, and ability to be a designated
competent person, but because of unique scenarios in the construction
and shipyard environments, those training requirements would vary
widely. OSHA concludes, therefore, that it is the employer's
responsibility to identify and provide any additional training that the
competent person would need to implement the written exposure control
plan.
Proposed paragraph (m)(4)(iii) required employers to provide
additional training when workplace changes (such as modification of
equipment, tasks, or procedures) result in new or increased employee
exposure that exceeds or can reasonably be expected to exceed either
the TWA PEL or the STEL. OSHA did not receive any comments on this
provision, and retains it in the final to ensure that employees are
aware of new or additional hazards. This training must be provided at
the time of (or prior to) the new or increased exposure, even if a year
has not passed since the previous training. New training would be
required under the standard if the employer changes work production
operations or personnel in a way that would require equipment to be
operated differently to avoid exposures above the TWA PEL or STEL.
Additional training would also be required if employers introduce new
production or personal protective equipment to employees who do not yet
know how to properly use the new equipment. Misuse of either the new
production equipment or PPE could result in new exposures above the TWA
PEL or STEL. Similarly, employers must provide additional training
before employees repair or upgrade engineering controls if exposures
during these activities will exceed or can reasonably be expected to
exceed either the TWA PEL or the STEL. OSHA has concluded that the
additional training requirement in this final rule is essential because
it ensures that employees are able to actively participate in
protecting themselves under the conditions found in the workplace, even
if those conditions change.
Proposed paragraph (m)(4)(iv) required the employer to make a copy
of the standard and its appendices readily available at no cost to each
employee and designated employee representative(s). OSHA did not
receive any comments on this provision, and the Agency has retained the
requirement in paragraph (m)(4)(iv) of the standards for general
industry and shipyards and paragraph (m)(3)(iv) of the standard for
construction. This is a common requirement in OSHA standards such as
Chromium (VI) (29 CFR 1910.1026), Acrylonitrile (29 CFR 1910.1045),
respirable crystalline silica (29 CFR 1910.1053), and Cotton Dust (29
CFR 1910.1043). The provision leaves employers free to determine the
best way to make the standard available, which could include giving the
employer a copy of the standard or placing a printed or electronic copy
in a central location that the employees can easily access. In order to
help ensure employees are protected against beryllium hazards, they
need to be familiar with and have access to the beryllium standard
applicable to their workplace (general industry, shipyard, or
construction), and be aware of the employer's obligations to comply
with it.
(n) Recordkeeping
Paragraph (n) of the final standards for general industry,
construction, and shipyards sets forth the employer's obligation to
comply with requirements to maintain records of air monitoring data,
objective data, medical surveillance, and training. The recordkeeping
requirements are in accordance with section 8(c) of the OSH Act (29
U.S.C. 657(c)), which authorizes OSHA to require employers to keep and
make available records as necessary or appropriate for the enforcement
of the Act or for developing information regarding the causes and
prevention of occupational injuries and illnesses. The recordkeeping
provisions are also consistent with OSHA's Access to Employee Exposure
and Medical Records (Records Access) standard at 29 CFR 1910.1020,
which addresses access to employee exposure and medical records.
As discussed in more detail below, the recordkeeping requirements
in the final standards are similar to those included in the proposal.
In the proposed rule, OSHA identified recordkeeping requirements for
exposure measurements, historical monitoring data, objective data,
medical surveillance, and training, and required employers to comply
with Record Access standard requirements regarding access to and
transfer of these records. Ameren Corporation (Ameren) expressed
support for these requirements (Document ID 1675, p. 7). All other
comments regarding the recordkeeping requirements focused on specific
areas of the recordkeeping requirements and are discussed in the
appropriate subject section.
Proposed paragraph (n)(1)(i) required employers to maintain records
of all
measurements taken to monitor employee exposure to beryllium as
required by paragraph (d) of the standard. OSHA did not receive
comments on this provision and has decided to retain it in the final
rule, in part, because it will enable both employers and OSHA to ensure
compliance with exposure assessment requirements under paragraph (d) of
the standards. It will also allow employers to ascertain which of the
final standards' provisions that are triggered at various exposure
levels apply to their employees. Thus, OSHA is retaining the proposed
provision with one minor modification. Specifically, the Agency has
added the words "make and" prior to "maintain" in order to clarify
that the employer's obligation is to create and preserve such records.
This clarification has also been made for other records required by the
final beryllium standards. The revised language is consistent with
OSHA's Records Access standard, which refers to employee exposure and
medical records that are made or maintained (29 CFR 1910.1020(b)(3)).
Proposed paragraph (n)(1)(ii) required that records of all
measurements taken to monitor employee exposure include at least the
following information: The date of measurement for each sample taken;
the operation being monitored; the sampling and analytical methods used
and evidence of their accuracy; the number, duration, and results of
samples taken; the type of personal protective clothing and equipment,
including respirators, worn by monitored employees at the time of
monitoring; and the name, social security number, and job
classification of each employee represented by the monitoring,
indicating which employees were actually monitored.
The Sampling and Analysis Subcommittee Task Group of the Beryllium
Health and Safety Committee (BHSC Task Group) recommended that the
recordkeeping provision should include the purpose and rationale for
the sampling performed as this would show that the exposure monitoring
requirements are being met (Document ID 1665, p. 2). After careful
consideration, OSHA has decided not to require that records include the
purpose and rationale for the sampling. The Agency points out that the
purpose and rationale for the sampling performed are dictated by the
exposure assessment provision in paragraph (d), which requires the
employer to assess the airborne exposure of each employee who is or may
reasonably be expected to be exposed to airborne beryllium in
accordance with either a performance option or the scheduled monitoring
option. The air monitoring requirements described in paragraph (d) and
the air monitoring data retention described in this section (paragraph
(n)) provide adequate information to show whether the exposure
monitoring requirements are being met. Furthermore, paragraphs
(n)(1)(ii)(A)-(F) of the standards are generally consistent with other
OSHA standards, such as respirable crystalline silica (29 CFR
1910.1053), chromium (VI) (29 CFR 1910.1026), and methylene chloride
(29 CFR 1910.1052).
OSHA received several comments regarding the requirement in
paragraph (n)(1)(ii)(F) that the employer include employee social
security numbers in exposure measurement records. The American Dental
Association (ADA), the Boeing Company (Boeing), and ORCHSE Strategies
(ORCHSE) cited employee privacy and identity theft concerns (Document
ID 1597, p. 4 (pdf); 1667, pp. 7-8; 1691, Attachment 1, p. 19). Boeing
and ORCHSE suggested the use of an identifier other than the social
security number, such as an employee identification number or another
unique personal identification number. The ADA recommended that
employers with fewer than ten employees should not be required to
include employee social security numbers in records required by the
standard. It further stated that some state statutes "impose data
security and breach notification requirements on those who collect
social security numbers," and in small businesses, "the risk to
employees of identity theft outweighs the difficulty of identifying
employee records" (Document ID 1597, p. 2-4 (pdf)).
OSHA has considered these comments and decided to retain the
requirement for including the employee's social security number in the
recordkeeping requirements of the rule. The requirement to use an
employee's social security number is a long-standing OSHA practice,
because a social security number is unique to an individual, is
retained for a lifetime, and does not change when an employee changes
employers. The social security number is therefore a useful tool for
evaluating an individual's exposure over time, particularly where
exposures are associated with chronic beryllium disease (CBD), which
has a varying rate of progression during which time an employee may
have several employers or had beryllium exposure sometime in the past.
OSHA recognizes the privacy concerns expressed by commenters
regarding this requirement, and understands the need to balance that
interest against the public health interest in requiring the social
security identifier. Instances of identity theft and breaches of
personal privacy are widely reported and concerning. However, OSHA has
concluded that this rule should adhere to the past, consistent practice
of requiring employee social security numbers on exposure records
mandated by every OSHA substance-specific health standard, and that any
change to the Agency's requirements for including employee social
security numbers on exposure records should be comprehensive and apply
to all OSHA standards, not just the standards for beryllium.
OSHA is proposing to delete the requirement that employers include
employee social security numbers in records required by its substance-
specific standards in the Agency's Standards Improvement Project--Phase
IV (SIP-IV) proposed rule (81 FR 68504, 68526-68528 (10/4/16)). OSHA
will revisit, if necessary, its decision to require employers to
maintain employee social security numbers in beryllium records in light
of the decision it makes in the SIP-IV rulemaking. In the meantime,
OSHA has included the requirement to use and retain social security
numbers in the final standards.
The ADA also urged OSHA to pursue Regulatory Alternative #1b, which
would exempt, except for recordkeeping purposes, operations where the
employer can show that employee exposures will not meet or exceed the
action level or exceed the STEL. It further argued under this option
that OSHA should limit employers' recordkeeping requirements to those
records that show that employees' exposure will not meet or exceed the
action level or exceed the STEL (Document ID 1597, p. 3 (pdf)). It
maintained that this is reasonable because the "employees are not at
significant risk of exposure" and "the record retention period is
onerous" (Document ID 1597, p. 3 (pdf)).
OSHA disagrees with this suggestion for several reasons. First, the
OSH Act states that standards adopted by OSHA must require employers
maintain "accurate records of employee exposures to potentially toxic
materials or harmful physical agents which are required to be monitored
or measured under section 6." OSH Act Sec. 8(c)(3). Thus, on its
face, the Act requires records of all exposure measurements required by
the final standards to be maintained, not just high ones. The OSH Act
also requires that employees have access to exposure records, (id.),
and requiring the employer to maintain those records helps to fulfill
that right. Further, as discussed in Section V,
Health Effects, and Section VII, Significant Risk, employees who are
exposed below the action level may still be at risk. Maintaining
records of those exposures may assist in the diagnosis of employee
disease long after the exposure occurs. It also allows employees to
have confidence that their exposures are within the requirements of the
final standards, and valuable insights about exposure control methods
may be gained through the review of exposure records, even those that
are below the action level. In addition, as the Supreme Court noted in
the Benzene case, air monitoring and medical testing, when done for
employees exposed below the PEL, "keep a constant check on the
validity of the assumptions made in developing" the PEL, giving a
basis to lower the PEL if necessary. Benzene, 448 U.S. at 657-58.
Requiring the employers to maintain those records furthers that
purpose. Other OSHA substance-specific rules also require employee
exposure records to be maintained, regardless of exposure level, such
as the standards addressing exposure to respirable crystalline silica
(29 CFR 1910.1053), methylene chloride (29 CFR 1910.1052), and chromium
(VI) (29 CFR 1910.1026).
Second, employee information and training requirements under
paragraph (m) of the standards apply to each employee who is or can
reasonably be expected to be exposed to airborne beryllium. As
discussed in paragraph (m) of the Summary and Explanation in this
preamble, OSHA finds that all employees who are or can be reasonably
expected to be exposed in this manner will benefit from the specified
forms of training. The creation and maintenance of training records
will permit both OSHA and employers to ensure that the required
training has occurred on schedule. Finally, OSHA notes that employers
may reduce their recordkeeping burden in some cases by ensuring their
employees are only exposed below the action level. For example, under
paragraph (k), employers are required to offer medical surveillance
those employees who meet certain exposure thresholds. By keeping
exposures level below the action level, employers decrease the
likelihood that their employees will fall into one of the enumerated
groups. If employers do not have any employees covered by medical
surveillance under paragraph (k), then they have no medical
surveillance records to retain under these standards.
As to the expense and difficulty of maintaining the records
required under these standards, OSHA recognizes that there will be
time, effort, and expense involved in maintaining medical records.
However, as stated earlier, OSHA expects that employers will have a
system for maintaining these records, just as they do for their other
business records. In addition, the Agency allows employers to use
whatever method works best for them in meeting these requirements,
paper or electronic (29 CFR 1910.1020(d)(2)).
In summary, paragraph (n)(1)(ii) in the final standards is
substantively unchanged from the proposed rule. However, OSHA has made
one editorial modification to paragraph (n)(1)(ii)(B), which is to
change "operation" to "task." Both "task" and "operation" are
commonly used in describing work. However, OSHA uses the term "task"
throughout the rule, and the Agency is using "task" in the
recordkeeping provision for consistency and to avoid any potential
misunderstanding that could result from using a different term. This
editorial change neither increases nor decreases an employer's
obligations as set forth in the proposed rule. The requirements of
paragraph (n)(1)(ii) are generally consistent with those found in other
OSHA standards, such as the standards for respirable crystalline silica
(29 CFR 1910.1053), methylene chloride (29 CFR 1910.1052), and chromium
(VI) (29 CFR 1910.1026).
Proposed paragraph (n)(1)(iii) required the employer to maintain
exposure records in accordance with OSHA's Records Access standard,
which specifies that exposure records must be maintained for 30 years
(29 CFR 1910.1020(d)(1)(ii)). The Agency did not receive comment on
this provision. However, OSHA has changed the requirement that the
employer "maintain this record as required by" OSHA's Records Access
standard to "ensure that exposure records are maintained and made
available in accordance with" that standard. OSHA believes that the
language of the final standard more clearly conveys the Agency's intent
that in addition to maintaining records, employers must make records
available to employees and others as specified in the Records Access
standard. As noted above, this clarifying change is editorial and
neither increases nor decreases an employer's obligations as set forth
in the proposed rule. This clarification has also been made for other
records required by the final beryllium standards.
Proposed paragraph (n)(2) contained the requirement to retain
records of any historical monitoring data used to satisfy the proposed
standard's the initial monitoring requirements. As explained in the
Summary and Explanation of paragraphs (b) and (d) in this preamble, the
definition of the term "objective data" in the final rule includes
all information that demonstrates airborne exposure to beryllium
associated with a particular product or material or a specific process,
task, or activity. Historical data that reflects workplace conditions
closely resembling or with a higher airborne exposure potential than
the processes, types of material, control methods, work practices, and
environmental conditions in the employer's current operations would be
considered objective data under the final rule. The requirement to keep
records of objective data is addressed under a separate paragraph.
Therefore, OSHA has chosen to delete the separate recordkeeping
requirement for historical data.
Proposed paragraph (n)(3) contained the requirements to keep
accurate records of objective data. Proposed paragraph (n)(3)(i)
required employers to establish and maintain accurate records of the
objective data relied upon to satisfy the requirement for initial
monitoring in proposed paragraph (d)(2). Under proposed paragraph
(n)(3)(ii), the record was required to contain at least the following
information: The data relied upon; the beryllium-containing material in
question; the source of the data; a description of the operation
exempted from initial monitoring and how the data supported the
exemption; and other information demonstrating that the data met the
requirements for objective data in accordance with paragraph
(d)(2)(ii).
OSHA did not receive comments regarding this provision, and the
Agency finds that it should be included in the final rule. Since
objective data may be used to exempt the employer from certain types of
monitoring, as specified in paragraph (d), it is critical that the use
of these types of data be carefully documented. Objective data are
intended to provide the same degree of assurance that employee
exposures have been correctly characterized as would exposure
assessment. The specified content elements are required to ensure that
the records are capable of demonstrating to OSHA a reasonable basis for
the conclusions drawn by the employer from the objective data.
Therefore, OSHA has included proposed paragraph (n)(3) as paragraph
(n)(2) in the final standards, with minor alterations. Specifically, in
the final standards, OSHA has changed paragraphs (n)(2)(ii)(D) to
require the record to contain "[a] description of the process, task,
or activity on which the objective data were based," and paragraph
(n)(2)(ii)(E) to require the
record to contain "[o]ther data relevant to the process, task,
activity, material, or airborne exposure on which the objective data
were based." These changes are editorial, and intended to clarify the
maintenance and availability of objective data records. They are only
intended to aid employers in determining the precise information to be
retained. They do not affect the employer's obligations as set forth in
the proposed rule.
Proposed paragraph (n)(3)(iii) required the employer to maintain a
record of objective data relied upon as required by the Records Access
standard, which specifies that exposure records must be maintained for
30 years (29 CFR 1910.1020(d)(1)(ii)). The Agency did not receive
comment on this provision. Objective data may include employee exposure
records that must be maintained, and therefore, the Agency has retained
it in the final standards as paragraph (n)(2)(iii). OSHA notes that
this final provision, like all of the final provisions in this
paragraph related to the Records Access standard, includes the non-
substantive change from the proposed requirement to maintain the record
as required by the Records Access standard, to the requirement to
maintain and make available the record in accordance with the Records
Access standard. OSHA's reasons for this change are discussed above.
Paragraph (n)(3) of the final standards, like paragraph (n)(4) of
the proposal, addresses medical surveillance records. Under proposed
paragraph (n)(4)(i), employers had to establish and maintain medical
surveillance records for each employee covered by the medical
surveillance requirements in paragraph (k) of the proposed standard.
Proposed paragraph (n)(4)(ii) listed the categories of information that
an employer was required to record: The employee's name, social
security number, and job classification; a copy of all licensed
physicians' written medical opinions; and a copy of the information
provided to the PLHCP as required by paragraph (k)(4) of the proposed
standard.
The ADA and ORCHSE questioned the requirement that the employee's
social security number be included in medical surveillance records
(Document ID 1597, pp. 2-4 (pdf); 1691, Attachment 1, p. 19). As noted
above in the discussion on exposure measurement records, OSHA finds the
privacy and security issues associated with the required use of social
security numbers are of concern. However, for the same reasons
discussed above, the Agency has decided to retain the requirement for
use of social security numbers in medical records. OSHA is examining
the requirements for social security numbers separately from this
rulemaking.
Medical records document the results of medical surveillance and
are especially important when an employee's medical condition places
him or her at increased risk of health impairment from further exposure
to beryllium in the workplace. Furthermore, the records can be used by
the Agency and others to identify illnesses and deaths that may be
attributable to beryllium exposure, evaluate compliance programs, and
assess the efficacy of the standards. OSHA concludes that medical
surveillance records are necessary and appropriate for protection of
employee health, enforcement of the standards, and development of
information regarding the causes and prevention of occupational
illnesses. Therefore, OSHA has decided to retain proposed paragraph
(n)(4)(ii)'s requirements regarding medical surveillance records in
paragraph (n)(3)(ii) of the final standards. However, OSHA has changed
the requirement in proposed paragraph (n)(4)(ii)(B) that the record
include copies of all licensed physicians' written opinions to the
requirement that the record include copies of all licensed physicians'
written medical opinions for each employee in paragraph (n)(3)(ii)(B)
of the final standards. These changes are editorial and intended to
clarify that employees are entitled to their own written medical
opinion, not all written opinions. This change neither increases nor
decreases an employer's obligations as set forth in the proposed rule.
Proposed paragraph (n)(4)(iii) required the employer to maintain
employee medical records for at least the duration of the employee's
employment plus 30 years in accordance with OSHA's Records Access
Standard at 29 CFR 1910.1020(d)(1)(i). The ADA objected to this
provision, arguing that the proposed retention period is onerous
(Document ID 1597, p. 3 (pdf)). OSHA has considered this comment and
concluded that the best approach is to maintain consistency with 29 CFR
1910.1020 and its required retention periods of (1) 30 years for
exposure records and objective data, and (2) the duration of employment
plus 30 years for medical surveillance records. It is necessary to keep
medical records for these extended time periods because of the varying
rate of progression for CBD and the long latency period between
exposure and development of lung cancer. OSHA recognizes that in some
cases, the latency period for beryllium-related cancer may extend
beyond 30 years. However, the Agency concludes that the retention
periods specified in 29 CFR 1910.1020 represent a reasonable balance
between the need to maintain records and the administrative burdens
associated with maintaining those records for extended time periods.
Because the 30-year, and the duration of employment plus 30-year,
record retention requirements are currently included in 29 CFR
1910.1020, these time periods are consistent with longstanding Agency
and employer practice. Other substance-specific rules are also subject
to the retention requirements of 29 CFR 1910.1020, such as the
standards addressing exposure to respirable crystalline silica (29 CFR
1910.1053), methylene chloride (29 CFR 1910.1052), and chromium (VI)
(29 CFR 1910.1026). Thus, OSHA finds that the 30-year retention period
is necessary and appropriate for exposure records, historical
monitoring data, and objective data, and that the duration of
employment plus 30-year retention period is necessary and appropriate
for medical surveillance records.
Therefore, OSHA has decided to include the retention periods
provided by the Records Access standard in paragraph (n)(3)(iii) of the
final standards. For the reasons discussed above, OSHA has added "and
made available" after "maintained" in paragraph (n)(3)(iii) of the
standards. Under the final standards, the employer is responsible for
the maintenance of records in his or her possession. The employer is
also responsible for ensuring the retention of records in the
possession of the licensed physician (e.g., the written medical reports
described in paragraph (n)(3) that are created pursuant to this rule's
medical surveillance requirements). This responsibility, which derives
from 29 CFR 1910.1020(b), means that employers must ensure that the
licensed physician retains a copy of medical records for the employee's
duration of employment plus 30 years. The employer can generally
fulfill this obligation by including the retention requirement in its
agreement with the licensed physician. The requirements are consistent
with other OSHA health standards, such as Hexavalent Chromium (VI) (29
CFR 1910.1026), respirable crystalline silica (29 CFR 1910.1053), and
Methylene Chloride (29 CFR 1910.1052).
Paragraph (n)(4) of the final standards, like proposed paragraph
(n)(5), addresses training records. Proposed paragraph (n)(5)(i)
required employers to prepare records of any training required by these
standards. At the completion of training, the employer
was required to prepare a record that included the name, social
security number, and job classification of each employee trained; the
date the training was completed; and the topic of the training. This
record maintenance requirement also applied to records of annual
retraining or additional training as described in paragraph (m)(4).
The ADA and ORCHSE questioned the requirement that the employee's
social security number be included in training records (Document ID
1597, p. 2-4 (pdf); 1691, Attachment 1, p. 19). As noted above in the
discussions on exposure measurement and medical surveillance records,
OSHA finds the privacy and security issues associated with the required
use of social security numbers are of concern. However, for the same
reasons discussed above, the Agency has decided to retain the
requirement for use of social security numbers in training records. As
stated above, OSHA is examining the requirements for social security
numbers separately from this rulemaking. In the meantime, OSHA has
retained the social security requirement in the final standards.
No other comments were received on this provision. Proposed
paragraph (n)(5)(i) is now paragraph (n)(4)(i) in the final standards.
Paragraph (n)(4)(i) in the final standards is substantively unchanged
from the proposal.
Proposed paragraph (n)(5)(ii) required employers to retain training
records, including records of annual retraining or additional training
required under these standards, for a period of three years after the
completion of the training. North America's Building Trades Unions
(NABTU) commented that employers "must maintain documentation of [any]
training" required for beryllium construction workers (Document ID
1679, p. 3). OSHA agrees. As noted above, OSHA finds that the creation
and maintenance of training records will permit both OSHA and employers
to ensure that the required training has occurred on schedule. Thus,
the Agency has included this provision in the standard for
construction, as well as the standards for general industry and
shipyards. Proposed paragraph (n)(5)(ii) is now paragraph (n)(4)(ii) in
the final standards, and is substantively unchanged from the proposal.
The three-year time period is consistent with the Bloodborne Pathogens
standard (29 CFR 1910.1030).
Paragraph (n)(5) of the final standards, like proposed paragraph
(n)(6), addresses access to records. Proposed paragraph (n)(6) required
employers to make all records mandated by these standards available for
examination and copying to the Assistant Secretary, the Director of
NIOSH, each employee, and each employee's designated representative as
stipulated by OSHA's Records Access standard (29 CFR 1910.1020). OSHA
did not receive comment on this provision, and includes it in the final
standards to emphasize and ensure proper employee and government access
to records.
Paragraph (n)(6) of the final standards, like proposed paragraph
(n)(7), addresses transfer of records. Proposed paragraph (n)(7)
required that employers comply with the Records Access standard
regarding the transfer of records. The requirements for the transfer of
records are explained in 29 CFR 1910.1020(h), which instructs employers
either to transfer records to successor employers or, if there is no
successor employer, to inform employees of their access rights at least
three months before the cessation of the employer's business. OSHA did
not receive comment on this provision, and includes it the final
standards to help ensure consistent records access.
(o) Dates
Paragraph (o) of the standards for general industry, construction,
and shipyards sets forth the effective date of the standards and the
dates for compliance with their requirements. OSHA proposed that the
final rule would become effective 60 days after its publication in the
Federal Register, and that employer obligations to comply with most
requirements of the final rule would begin 90 days after the effective
date (150 days after publication of the final rule), while the
requirements for establishing change rooms and implementing engineering
controls would begin one year and two years after the effective date,
respectively. Ameren, AFL-CIO, and United Steelworkers expressed
support for the proposed effective and compliance dates (Document ID
1675, p. 7; 1681, Attachment 1, p. 15; 1689, p. 15).
OSHA sets the effective date to allow sufficient time for employers
to obtain the standard and read and understand its requirements.
Unchanged from the proposal, paragraph (o)(1) provides that the
standards will become effective on March 10, 2017.
OSHA sets the compliance dates to allow sufficient time for
employers to undertake the necessary planning and preparation for
compliance with the various provisions of the standards. In addition to
the default compliance date of 90 days that applied to most provisions,
OSHA's proposal included extended compliance dates for the provisions
that require the establishment of change rooms and the implementation
of engineering controls in order to give affected employers sufficient
time to design and construct change rooms where necessary, and to
design, obtain, and install any required control equipment. In response
to comments stating that more time is necessary to prepare for
compliance, the compliance dates in the final rule have been extended
from those proposed.
Paragraph (o)(2) of the standards establishes the dates for
compliance with the requirements of the standard. Several employers and
industry representatives commented that the proposal's default
compliance date (90 days after the effective date) provided inadequate
time to prepare for compliance. ORCHSE Strategies (ORCHSE) commented
that an additional six months are needed "to make necessary changes to
facilities, broad-based exposure assessments, and delineate work and
regulated areas" (Document ID 1691, Attachment 1, p. 24). Also, the
Boeing Company (Boeing) commented that the standard should require
compliance two years after the effective date, explaining that "it
will take, for a company of our size, between 1 and 2 years to
accurately and comprehensively determine what our exposures are, prior
to developing and implementing an exposure plan" (Document ID 1667, p.
8).
The Sampling and Analysis Subcommittee Task Group of the Beryllium
Health and Safety Committee (BHSC Task Group) also commented on the
amount of time needed to comply with the "Accuracy of Measurement"
requirement in paragraph (d)(1)(v) of the proposal, which has been
renamed "Methods of sample analysis" and moved to paragraph (d)(5) in
the final standards (Document ID 1665, p. 3). Specifically, BHSC Task
Group expressed concern that laboratories would need to adopt newer
analytical methods not widely used by the majority of analytical
laboratories to perform beryllium measurements to the level of accuracy
specified by the standard. BHSC Task Group acknowledges that although
the OSHA rule does not require it, a Department of Energy requirement
for accreditation that exists in their Beryllium Worker Safety and
Health Program would drive laboratories to obtain accreditation by an
external accrediting body to use these newer methods, which can take
well over 150 days. (Document ID 1665, p. 3-4). OSHA rejects the
reasoning behind BHSC Task Group's concern on the amount of time needed
to comply the accuracy of measurement
requirement, as the newer analytical methods for beryllium are
available and, as pointed out by BHSC Task Group, OSHA does not require
laboratories to be accredited in these methods to comply with the
standards.
Nonetheless, OSHA recognizes the concerns expressed by Boeing,
ORCHSE, and BHSC Task Group that employers may need additional time to
assess exposures and undertake the necessary planning and preparation
for compliance with the obligations of the standards, and has
determined that some of those concerns are reasonable. OSHA has
therefore extended the final standards' default compliance date, which
applies to all provisions except for those with separate compliance
dates under paragraphs (o)(2)(i) and (o)(2)(ii), to one year from the
effective date.
Paragraph (o)(2)(i) of the standards provides the date for
compliance with the requirement in paragraph (i) to establish change
rooms, and in the general industry standard, to provide showers. OSHA
proposed a compliance date of one year after the effective date for
establishing change rooms, but commenters indicated that more time was
needed to modify their facilities. Boeing requested that the compliance
date for establishing change rooms begin three years after the
effective date, stating that "for large facilities, modifications such
as showers, clothing storage and change rooms need a significant amount
of time to be planned, designed, contracted, and constructed within
operating factory sites" (Document ID 1667, p. 8). ORCHSE also
indicated that additional time is needed to "make necessary changes to
facilities" (Document ID 1691, Attachment 1, p. 24).
OSHA expects that most employers will be able to establish change
rooms and showers within a year of the effective date, but the Agency
understands that some employers, both large and small, may need
additional time to plan and construct these areas. OSHA is persuaded by
the concerns expressed by the commenters that employers may need
additional time to modify their facilities, and has extended the
compliance date for the general industry standard's change rooms and
showers requirements to two years after the effective date. Providing
an extended compliance date for establishing change rooms and providing
showers is consistent with the approach taken in OSHA's general
industry standard for Cadmium (29 CFR 1910.1027(p)(2)(vi)(B)).
The construction and shipyard standards do not require employers to
provide showers, but OSHA recognizes that construction and shipyard
employers may also need additional time to plan and establish change
rooms at construction sites and shipyard industry establishments.
Change room facilities in these industries may be permanent or
temporary, including mobile units that can be purchased or rented. OSHA
has thus set the compliance date for the construction and shipyard
standards' requirement to establish change rooms to two years after the
effective date.
Paragraph (o)(2)(ii) of the standards provides the date for
compliance with the requirements in paragraph (f) to implement
engineering controls. OSHA proposed a compliance date of two years
after the effective date for employers to comply with the engineering
control requirements in paragraph (f). Boeing, however, commented that
the compliance date for implementing engineering controls should be
extended to four years after the effective date, explaining that "for
large companies, exposure assessments and feasibility studies would
have to be completed on a vast scale, and then engineering controls may
have to be installed," making four years "a reasonable time frame for
these compliance measures" (Document ID 1667, pp. 8). The Non-Ferrous
Founders' Society (NFFS) also commented that a two-year implementation
period was insufficient because it takes 12 to 24 months to obtain an
Environmental Protection Agency (EPA) permit for changes to ventilation
systems, and foundries cannot begin work to modify ventilation systems
until they obtain a permit (Document ID 1756, Tr. 61-62).
OSHA recognizes the concerns expressed by Boeing regarding the time
needed to implement engineering controls, but does not agree that four
years are needed to comply with the engineering control requirements.
OSHA expects that many workplaces with beryllium will already have
engineering controls in place for other hazardous materials that will
need only modification or updating to comply with the final standards.
For new installations, most types of engineering controls for working
with materials such as beryllium are readily available.
Furthermore, because beryllium is regulated under EPA rules as a
"hazardous air pollutant" with a relatively low volume threshold for
a permit requirement, foundries that already exhaust beryllium in any
quantity would likely already be subjected to the permitting
requirements. Therefore, OSHA predicts that any changes to ventilation
systems to comply with the final beryllium standards would generally
only be subject to routine reporting requirements or permit
modifications. Cases that are unusually problematic, however, can be
addressed through OSHA's enforcement discretion if the employer can
show that it has made good faith efforts to implement engineering
controls, but has been unable to implement such controls due to the
time needed for environmental permitting.
However, OSHA acknowledges that some general industry, construction
and shipyard employers may need more than two years to comply with the
engineering control obligations in paragraph (f), including the need to
update any permits before modifying ventilation systems, and has
extended the standards' compliance date for the engineering control
requirements to three years from the effective date. OSHA has
determined that setting a compliance date three years after the
effective date will ensure that employers have sufficient time to
complete the process of designing, obtaining, and installing the
necessary control equipment.
OSHA's decision here to provide employers with an extended deadline
for complying with engineering control requirements is consistent with
what the Agency has done in health standards, including standards for
respirable crystalline silica (29 CFR 1910.1053(l)), Chromium (VI) (29
CFR 1910.1026(n)(3), 29 CFR 1915.1026(l)(3), 29 CFR 1926.1126(l)(3)),
and Cadmium (29 CFR 1910.1027(p)(2)(v)). Extending the compliance
deadline for implementation of engineering controls will allow those
firms that need extensive engineering controls time to adequately plan
for and implement the controls, which will thus help to ensure that
adequate protection is provided for workers. OSHA has also determined
that the extension will have the ancillary benefit of limiting the
economic impact of the rule by providing employers with additional time
to plan for and absorb the costs associated with compliance. Based on
its review of the rulemaking record, OSHA has concluded that employers
will be able to implement engineering controls within the extended time
frame that is established in the final rule.
(p) Appendix A to 29 CFR 1910.1024--Control Strategies To Minimize
Beryllium Exposure
Appendix A to the final standard for general industry, 29 CFR
1910.1024, provides information to employers on
control options that employers could use to comply with paragraph
(f)(2)(i) of the final rule, which requires employers to ensure that at
least one of the types of controls listed in paragraph (f)(2)(i) is in
place to reduce airborne exposure for each operation in a beryllium
work area that releases airborne beryllium. Appendix A is for
informational and guidance purposes only and none of the statements in
Appendix A should be construed as imposing a mandatory requirement on
employers that is not otherwise imposed by the standard. In addition,
this appendix is not intended to detract from any obligation that the
rule imposes.
The control strategies to minimize beryllium exposure were in
Appendix B of the proposed rule, but proposed Appendix B has been
redesignated as Appendix A in the final standard for general industry,
following the deletion (discussed below) of proposed Appendix A. The
information on control strategies presented in the appendix was derived
from OSHA's analysis of the technological feasibility of the PELs,
presented in Chapter IV of the Final Economic Analysis. The content of
Appendix A of the final standard for general industry remains unchanged
from that contained in Appendix B of the proposal.
The proposed rule also contained a non-mandatory appendix
(designated in the proposal as Appendix A) that provided technical
information on the BeLPT test. OSHA has determined that the information
contained in proposed Appendix A is more suitable for separate guidance
that will be issued in conjunction with the standards. OSHA will be
able to more readily update this separate guidance to reflect
technological advances and changes in recommendations from the medical
community. Therefore, OSHA is not including proposed Appendix A in the
final standards.
OSHA has also not included any appendices in the final standards
for construction and shipyards since OSHA has identified only one
principle operation (abrasive blasting) in these sectors involving
worker exposure to beryllium.
List of Subjects in 29 CFR Parts 1910, 1915, and 1926
Beryllium, Cancer, Chemicals, Hazardous substances, Health,
Occupational safety and health, Reporting and recordkeeping
requirements.
Authority and Signature
This document was prepared under the direction of David Michaels,
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210.
The Agency issues the sections under the following authorities: 29
U.S.C. 653, 655, 657; 40 U.S.C. 3704; 33 U.S.C. 941; Secretary of
Labor's Order 1-2012 (77 FR 3912 (1/25/2012)); and 29 CFR part 1911.
Signed at Washington, DC, on December 14, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
Amendments to Standards
For the reasons set forth in the preamble, Chapter XVII of Title
29, parts 1910, 1915, and 1926, of the Code of Federal Regulations is
amended as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
Subpart Z--[Amended]
0
1. The authority citation for subpart Z of part 1910 is revised to read
as follows:
Authority: 29 U.S.C. 653, 655, 657) Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR
65008), 5-2007 (72 FR 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR
3912), 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat.
1901.
Section 1910.1201 also issued under 49 U.S.C. 5101 et seq.
0
2. In Sec. 1910.1000, paragraph (e):
0
a. Amend Table Z-1--Limits on Air Contaminants, by revising the entry
for "Beryllium and beryllium compounds (as Be)" and adding footnote
8.
0
b. Amend Table Z-2 by revising the entry for "Beryllium and beryllium
compounds (Z37.29-1970)"; and adding footnote d.
The revisions read as follows:
Sec. 1910.1000 Air contaminants.
* * * * *
Table Z-1--Limits for Air Contaminants
----------------------------------------------------------------------------------------------------------------
mg/m3\ (b) Skin
Substance CAS No. (c) ppm (a) 1 1 designation
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beryllium and beryllium compounds (as Be); see 7440-41-7 .............. .............. ..............
1910.1024 8.................................
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * * * *
8 See Table Z-2 for the exposure limits for any operations or sectors where the exposure limits in Sec.
1910.1024 are stayed or otherwise not in effect.
Table Z-2
----------------------------------------------------------------------------------------------------------------
Acceptable maximum peak above the
Acceptable acceptable ceiling average
Substance 8-hour time ceiling concentration for an 8-hr shift
weighted average concentration ---------------------------------------
Concentration Maximum duration
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beryllium and beryllium 2 μg/m3\...... 5 μg/m3\...... 25 μg/m3\..... 30 minutes.
compounds (Z37.29-1970) \d\.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * * * *
\d\ This standard applies to any operations or sectors for which the exposure limits in the beryllium standard,
Sec. 1910.1024, are stayed or is otherwise not in effect.
* * * * *
0
3. Add Sec. 1910.1024 to read as follows:
Sec. 1910.1024 Beryllium.
(a) Scope and application. (1) This standard applies to
occupational exposure to beryllium in all forms, compounds, and
mixtures in general industry, except those articles and materials
exempted by paragraphs (a)(2) and (a)(3) of this standard.
(2) This standard does not apply to articles, as defined in the
Hazard Communication standard (HCS) (Sec. 1910.1200(c)), that contain
beryllium and that the employer does not process.
(3) This standard does not apply to materials containing less than
0.1% beryllium by weight where the employer has objective data
demonstrating that employee exposure to beryllium will remain below the
action level as an 8-hour TWA under any foreseeable conditions.
(b) Definitions. As used in this standard:
Action level means a concentration of airborne beryllium of 0.1
micrograms per cubic meter of air (μg/m3\) calculated as an 8-hour
time-weighted average (TWA).
Airborne exposure and airborne exposure to beryllium mean the
exposure to airborne beryllium that would occur if the employee were
not using a respirator.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, United States Department of Labor, or
designee.
Beryllium lymphocyte proliferation test (BeLPT) means the
measurement of blood lymphocyte proliferation in a laboratory test when
lymphocytes are challenged with a soluble beryllium salt.
Beryllium work area means any work area containing a process or
operation that can release beryllium where employees are, or can
reasonably be expected to be, exposed to airborne beryllium at any
level or where there is the potential for dermal contact with
beryllium.
CBD diagnostic center means a medical diagnostic center that has an
on-site pulmonary specialist and on-site facilities to perform a
clinical evaluation for the presence of chronic beryllium disease
(CBD). This evaluation must include pulmonary function testing (as
outlined by the American Thoracic Society criteria), bronchoalveolar
lavage (BAL), and transbronchial biopsy. The CBD diagnostic center must
also have the capacity to transfer BAL samples to a laboratory for
appropriate diagnostic testing within 24 hours. The on-site pulmonary
specialist must be able to interpret the biopsy pathology and the BAL
diagnostic test results.
Chronic beryllium disease (CBD) means a chronic lung disease
associated with airborne exposure to beryllium.
Confirmed positive means the person tested has beryllium
sensitization, as indicated by two abnormal BeLPT test results, an
abnormal and a borderline test result, or three borderline test
results. It also means the result of a more reliable and accurate test
indicating a person has been identified as having beryllium
sensitization.
Director means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee.
Emergency means any uncontrolled release of airborne beryllium.
High-efficiency particulate air (HEPA) filter means a filter that
is at least 99.97 percent efficient in removing particles 0.3
micrometers in diameter.
Objective data means information, such as air monitoring data from
industry-wide surveys or calculations based on the composition of a
substance, demonstrating airborne exposure to beryllium associated with
a particular product or material or a specific process, task, or
activity. The data must reflect workplace conditions closely resembling
or with a higher airborne exposure potential than the processes, types
of material, control methods, work practices, and environmental
conditions in the employer's current operations.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services required by paragraph (k) of this standard.
Regulated area means an area, including temporary work areas where
maintenance or non-routine tasks are performed, where an employee's
airborne exposure exceeds, or can reasonably be expected to exceed,
either the time-weighted average (TWA) permissible exposure limit (PEL)
or short term exposure limit (STEL).
This standard means this beryllium standard, 29 CFR 1910.1024.
(c) Permissible Exposure Limits (PELs)--(1) Time-weighted average
(TWA) PEL. The employer must ensure that no employee is exposed to an
airborne concentration of beryllium in excess of 0.2 μg/m3\
calculated as an 8-hour TWA.
(2) Short-term exposure limit (STEL). The employer must ensure that
no employee is exposed to an airborne concentration of beryllium in
excess of 2.0 μg/m3\ as determined over a sampling period of 15
minutes.
(d) Exposure assessment--(1) General. The employer must assess the
airborne exposure of each employee who is or may reasonably be expected
to be exposed to airborne beryllium in accordance with either the
performance option in paragraph (d)(2) or the scheduled monitoring
option in paragraph (d)(3) of this standard.
(2) Performance option. The employer must assess the 8-hour TWA
exposure and the 15-minute short-term exposure for each employee on the
basis of any combination of air monitoring data and objective data
sufficient to accurately characterize airborne exposure to beryllium.
(3) Scheduled monitoring option. (i) The employer must perform
initial monitoring to assess the 8-hour TWA exposure for each employee
on the basis of one or more personal breathing zone air samples that
reflect the airborne
exposure of employees on each shift, for each job classification, and
in each work area.
(ii) The employer must perform initial monitoring to assess the
short-term exposure from 15-minute personal breathing zone air samples
measured in operations that are likely to produce airborne exposure
above the STEL for each work shift, for each job classification, and in
each work area.
(iii) Where several employees perform the same tasks on the same
shift and in the same work area, the employer may sample a
representative fraction of these employees in order to meet the
requirements of this paragraph (d)(3). In representative sampling, the
employer must sample the employee(s) expected to have the highest
airborne exposure to beryllium.
(iv) If initial monitoring indicates that airborne exposure is
below the action level and at or below the STEL, the employer may
discontinue monitoring for those employees whose airborne exposure is
represented by such monitoring.
(v) Where the most recent exposure monitoring indicates that
airborne exposure is at or above the action level but at or below the
TWA PEL, the employer must repeat such monitoring within six months of
the most recent monitoring.
(vi) Where the most recent exposure monitoring indicates that
airborne exposure is above the TWA PEL, the employer must repeat such
monitoring within three months of the most recent 8-hour TWA exposure
monitoring.
(vii) Where the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the action level, the
employer must repeat such monitoring within six months of the most
recent monitoring until two consecutive measurements, taken 7 or more
days apart, are below the action level, at which time the employer may
discontinue 8-hour TWA exposure monitoring for those employees whose
exposure is represented by such monitoring, except as otherwise
provided in paragraph (d)(4) of this standard.
(viii) Where the most recent exposure monitoring indicates that
airborne exposure is above the STEL, the employer must repeat such
monitoring within three months of the most recent short-term exposure
monitoring until two consecutive measurements, taken 7 or more days
apart, are below the STEL, at which time the employer may discontinue
short-term exposure monitoring for those employees whose exposure is
represented by such monitoring, except as otherwise provided in
paragraph (d)(4) of this standard.
(4) Reassessment of exposure. The employer must reassess airborne
exposure whenever a change in the production, process, control
equipment, personnel, or work practices may reasonably be expected to
result in new or additional airborne exposure at or above the action
level or STEL, or when the employer has any reason to believe that new
or additional airborne exposure at or above the action level or STEL
has occurred.
(5) Methods of sample analysis. The employer must ensure that all
air monitoring samples used to satisfy the monitoring requirements of
paragraph (d) of this standard are evaluated by a laboratory that can
measure beryllium to an accuracy of plus or minus 25 percent within a
statistical confidence level of 95 percent for airborne concentrations
at or above the action level.
(6) Employee notification of assessment results. (i) Within 15
working days after completing an exposure assessment in accordance with
paragraph (d) of this standard, the employer must notify each employee
whose airborne exposure is represented by the assessment of the results
of that assessment individually in writing or post the results in an
appropriate location that is accessible to each of these employees.
(ii) Whenever an exposure assessment indicates that airborne
exposure is above the TWA PEL or STEL, the employer must describe in
the written notification the corrective action being taken to reduce
airborne exposure to or below the exposure limit(s) exceeded where
feasible corrective action exists but had not been implemented when the
monitoring was conducted.
(7) Observation of monitoring. (i) The employer must provide an
opportunity to observe any exposure monitoring required by this
standard to each employee whose airborne exposure is measured or
represented by the monitoring and each employee's representative(s).
(ii) When observation of monitoring requires entry into an area
where the use of personal protective clothing or equipment (which may
include respirators) is required, the employer must provide each
observer with appropriate personal protective clothing and equipment at
no cost to the observer and must ensure that each observer uses such
clothing and equipment.
(iii) The employer must ensure that each observer follows all other
applicable safety and health procedures.
(e) Beryllium work areas and regulated areas--(1) Establishment.
(i) The employer must establish and maintain a beryllium work area
wherever the criteria for a "beryllium work area" set forth in
paragraph (b) of this standard are met.
(ii) The employer must establish and maintain a regulated area
wherever employees are, or can reasonably be expected to be, exposed to
airborne beryllium at levels above the TWA PEL or STEL.
(2) Demarcation. (i) The employer must identify each beryllium work
area through signs or any other methods that adequately establish and
inform each employee of the boundaries of each beryllium work area.
(ii) The employer must identify each regulated area in accordance
with paragraph (m)(2) of this standard.
(3) Access. The employer must limit access to regulated areas to:
(i) Persons the employer authorizes or requires to be in a
regulated area to perform work duties;
(ii) Persons entering a regulated area as designated
representatives of employees for the purpose of exercising the right to
observe exposure monitoring procedures under paragraph (d)(7) of this
standard; and
(iii) Persons authorized by law to be in a regulated area.
(4) Provision of personal protective clothing and equipment,
including respirators. The employer must provide and ensure that each
employee entering a regulated area uses:
(i) Respiratory protection in accordance with paragraph (g) of this
standard; and
(ii) Personal protective clothing and equipment in accordance with
paragraph (h) of this standard.
(f) Methods of compliance--(1) Written exposure control plan. (i)
The employer must establish, implement, and maintain a written exposure
control plan, which must contain:
(A) A list of operations and job titles reasonably expected to
involve airborne exposure to or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to
involve airborne exposure at or above the action level;
(C) A list of operations and job titles reasonably expected to
involve airborne exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination, including
preventing the transfer of beryllium between surfaces, equipment,
clothing, materials, and articles within beryllium work areas;
(E) Procedures for keeping surfaces as free as practicable of
beryllium;
(F) Procedures for minimizing the migration of beryllium from
beryllium work areas to other locations within or outside the
workplace;
(G) A list of engineering controls, work practices, and respiratory
protection required by paragraph (f)(2) of this standard;
(H) A list of personal protective clothing and equipment required
by paragraph (h) of this standard; and
(I) Procedures for removing, laundering, storing, cleaning,
repairing, and disposing of beryllium-contaminated personal protective
clothing and equipment, including respirators.
(ii) The employer must review and evaluate the effectiveness of
each written exposure control plan at least annually and update it, as
necessary, when:
(A) Any change in production processes, materials, equipment,
personnel, work practices, or control methods results, or can
reasonably be expected to result, in new or additional airborne
exposure to beryllium;
(B) The employer is notified that an employee is eligible for
medical removal in accordance with paragraph (l)(1) of this standard,
referred for evaluation at a CBD diagnostic center, or shows signs or
symptoms associated with airborne exposure to or dermal contact with
beryllium; or
(C) The employer has any reason to believe that new or additional
airborne exposure is occurring or will occur.
(iii) The employer must make a copy of the written exposure control
plan accessible to each employee who is, or can reasonably be expected
to be, exposed to airborne beryllium in accordance with OSHA's Access
to Employee Exposure and Medical Records (Records Access) standard
(Sec. 1910.1020(e)).
(2) Engineering and work practice controls. (i) For each operation
in a beryllium work area that releases airborne beryllium, the employer
must ensure that at least one of the following is in place to reduce
airborne exposure:
(A) Material and/or process substitution;
(B) Isolation, such as ventilated partial or full enclosures;
(C) Local exhaust ventilation, such as at the points of operation,
material handling, and transfer; or
(D) Process control, such as wet methods and automation.
(ii) An employer is exempt from using the controls listed in
paragraph (f)(2)(i) of this standard to the extent that:
(A) The employer can establish that such controls are not feasible;
or
(B) The employer can demonstrate that airborne exposure is below
the action level, using no fewer than two representative personal
breathing zone samples taken at least 7 days apart, for each affected
operation.
(iii) If airborne exposure exceeds the TWA PEL or STEL after
implementing the control(s) required by paragraph (f)(2)(i) of this
standard, the employer must implement additional or enhanced
engineering and work practice controls to reduce airborne exposure to
or below the exposure limit(s) exceeded.
(iv) Wherever the employer demonstrates that it is not feasible to
reduce airborne exposure to or below the PELs by the engineering and
work practice controls required by paragraphs (f)(2)(i) and (f)(2)(iii)
of this standard, the employer must implement and maintain engineering
and work practice controls to reduce airborne exposure to the lowest
levels feasible and supplement these controls by using respiratory
protection in accordance with paragraph (g) of this standard.
(3) Prohibition of rotation. The employer must not rotate employees
to different jobs to achieve compliance with the PELs.
(g) Respiratory protection--(1) General. The employer must provide
respiratory protection at no cost to the employee and ensure that each
employee uses respiratory protection:
(i) During periods necessary to install or implement feasible
engineering and work practice controls where airborne exposure exceeds,
or can reasonably be expected to exceed, the TWA PEL or STEL;
(ii) During operations, including maintenance and repair activities
and non-routine tasks, when engineering and work practice controls are
not feasible and airborne exposure exceeds, or can reasonably be
expected to exceed, the TWA PEL or STEL;
(iii) During operations for which an employer has implemented all
feasible engineering and work practice controls when such controls are
not sufficient to reduce airborne exposure to or below the TWA PEL or
STEL;
(iv) During emergencies; and
(v) When an employee who is eligible for medical removal under
paragraph (l)(1) chooses to remain in a job with airborne exposure at
or above the action level, as permitted by paragraph (l)(2)(ii) of this
standard.
(2) Respiratory protection program. Where this standard requires an
employer to provide respiratory protection, the selection and use of
such respiratory protection must be in accordance with the Respiratory
Protection standard (Sec. 1910.134).
(3) The employer must provide at no cost to the employee a powered
air-purifying respirator (PAPR) instead of a negative pressure
respirator when
(i) Respiratory protection is required by this standard;
(ii) An employee entitled to such respiratory protection requests a
PAPR; and
(iii) The PAPR provides adequate protection to the employee in
accordance with paragraph (g)(2) of this standard.
(h) Personal protective clothing and equipment--(1) Provision and
use. The employer must provide at no cost, and ensure that each
employee uses, appropriate personal protective clothing and equipment
in accordance with the written exposure control plan required under
paragraph (f)(1) of this standard and OSHA's Personal Protective
Equipment standards (subpart I of this part):
(i) Where airborne exposure exceeds, or can reasonably be expected
to exceed, the TWA PEL or STEL; or
(ii) Where there is a reasonable expectation of dermal contact with
beryllium.
(2) Removal and storage. (i) The employer must ensure that each
employee removes all beryllium-contaminated personal protective
clothing and equipment at the end of the work shift, at the completion
of tasks involving beryllium, or when personal protective clothing or
equipment becomes visibly contaminated with beryllium, whichever comes
first.
(ii) The employer must ensure that each employee removes beryllium-
contaminated personal protective clothing and equipment as specified in
the written exposure control plan required by paragraph (f)(1) of this
standard.
(iii) The employer must ensure that each employee stores and keeps
beryllium-contaminated personal protective clothing and equipment
separate from street clothing and that storage facilities prevent
cross-contamination as specified in the written exposure control plan
required by paragraph (f)(1) of this standard.
(iv) The employer must ensure that no employee removes beryllium-
contaminated personal protective clothing or equipment from the
workplace, except for employees authorized to do so for the purposes of
laundering, cleaning, maintaining or disposing of beryllium-
contaminated personal protective clothing and equipment at an
appropriate location or facility away from the workplace.
(v) When personal protective clothing or equipment required by this
standard is removed from the workplace for laundering, cleaning,
maintenance or disposal, the employer must ensure that
personal protective clothing and equipment are stored and transported
in sealed bags or other closed containers that are impermeable and are
labeled in accordance with paragraph (m)(3) of this standard and the
HCS (Sec. 1910.1200).
(3) Cleaning and replacement. (i) The employer must ensure that all
reusable personal protective clothing and equipment required by this
standard is cleaned, laundered, repaired, and replaced as needed to
maintain its effectiveness.
(ii) The employer must ensure that beryllium is not removed from
personal protective clothing and equipment by blowing, shaking or any
other means that disperses beryllium into the air.
(iii) The employer must inform in writing the persons or the
business entities who launder, clean or repair the personal protective
clothing or equipment required by this standard of the potentially
harmful effects of airborne exposure to and dermal contact with
beryllium and that the personal protective clothing and equipment must
be handled in accordance with this standard.
(i) Hygiene areas and practices--(1) General. For each employee
working in a beryllium work area, the employer must:
(i) Provide readily accessible washing facilities in accordance
with this standard and the Sanitation standard (Sec. 1910.141) to
remove beryllium from the hands, face, and neck; and
(ii) Ensure that employees who have dermal contact with beryllium
wash any exposed skin at the end of the activity, process, or work
shift and prior to eating, drinking, smoking, chewing tobacco or gum,
applying cosmetics, or using the toilet.
(2) Change rooms. In addition to the requirements of paragraph
(i)(1)(i) of this standard, the employer must provide employees who
work in a beryllium work area with a designated change room in
accordance with this standard and the Sanitation standard (Sec.
1910.141) where employees are required to remove their personal
clothing.
(3) Showers. (i) The employer must provide showers in accordance
with the Sanitation standard (Sec. 1910.141) where:
(A) Airborne exposure exceeds, or can reasonably be expected to
exceed, the TWA PEL or STEL; and
(B) Beryllium can reasonably be expected to contaminate employees'
hair or body parts other than hands, face, and neck.
(ii) Employers required to provide showers under paragraph
(i)(3)(i) of this standard must ensure that each employee showers at
the end of the work shift or work activity if:
(A) The employee reasonably could have had airborne exposure above
the TWA PEL or STEL; and
(B) Beryllium could reasonably have contaminated the employee's
hair or body parts other than hands, face, and neck.
(4) Eating and drinking areas. Wherever the employer allows
employees to consume food or beverages at a worksite where beryllium is
present, the employer must ensure that:
(i) Surfaces in eating and drinking areas are as free as
practicable of beryllium;
(ii) No employees enter any eating or drinking area with personal
protective clothing or equipment unless, prior to entry, surface
beryllium has been removed from the clothing or equipment by methods
that do not disperse beryllium into the air or onto an employee's body;
and
(iii) Eating and drinking facilities provided by the employer are
in accordance with the Sanitation standard (Sec. 1910.141).
(5) Prohibited activities. The employer must ensure that no
employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in
regulated areas.
(j) Housekeeping--(1) General. (i) The employer must maintain all
surfaces in beryllium work areas as free as practicable of beryllium
and in accordance with the written exposure control plan required under
paragraph (f)(1) and the cleaning methods required under paragraph
(j)(2) of this standard; and
(ii) The employer must ensure that all spills and emergency
releases of beryllium are cleaned up promptly and in accordance with
the written exposure control plan required under paragraph (f)(1) and
the cleaning methods required under paragraph (j)(2) of this standard.
(2) Cleaning methods. (i) The employer must ensure that surfaces in
beryllium work areas are cleaned by HEPA-filtered vacuuming or other
methods that minimize the likelihood and level of airborne exposure.
(ii) The employer must not allow dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
airborne exposure are not safe or effective.
(iii) The employer must not allow the use of compressed air for
cleaning beryllium-contaminated surfaces unless the compressed air is
used in conjunction with a ventilation system designed to capture the
particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air
to clean beryllium-contaminated surfaces, the employer must provide,
and ensure that each employee uses, respiratory protection and personal
protective clothing and equipment in accordance with paragraphs (g) and
(h) of this standard.
(v) The employer must ensure that cleaning equipment is handled and
maintained in a manner that minimizes the likelihood and level of
airborne exposure and the re-entrainment of airborne beryllium in the
workplace.
(3) Disposal. The employer must ensure that:
(i) Materials designated for disposal that contain or are
contaminated with beryllium are disposed of in sealed, impermeable
enclosures, such as bags or containers, that are labeled in accordance
with paragraph (m)(3) of this standard; and
(ii) Materials designated for recycling that contain or are
contaminated with beryllium are cleaned to be as free as practicable of
surface beryllium contamination and labeled in accordance with
paragraph (m)(3) of this standard, or placed in sealed, impermeable
enclosures, such as bags or containers, that are labeled in accordance
with paragraph (m)(3) of this standard.
(k) Medical surveillance--(1) General. (i) The employer must make
medical surveillance required by this paragraph available at no cost to
the employee, and at a reasonable time and place, to each employee:
(A) Who is or is reasonably expected to be exposed at or above the
action level for more than 30 days per year;
(B) Who shows signs or symptoms of CBD or other beryllium-related
health effects;
(C) Who is exposed to beryllium during an emergency; or
(D) Whose most recent written medical opinion required by paragraph
(k)(6) or (k)(7) of this standard recommends periodic medical
surveillance.
(ii) The employer must ensure that all medical examinations and
procedures required by this standard are performed by, or under the
direction of, a licensed physician.
(2) Frequency. The employer must provide a medical examination:
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A),
unless the employee has received a medical examination, provided in
accordance
with this standard, within the last two years; or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or
(C).
(ii) At least every two years thereafter for each employee who
continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D)
of this standard.
(iii) At the termination of employment for each employee who meets
any of the criteria of paragraph (k)(1)(i) of this standard at the time
the employee's employment terminates, unless an examination has been
provided in accordance with this standard during the six months prior
to the date of termination.
(3) Contents of examination. (i) The employer must ensure that the
PLHCP conducting the examination advises the employee of the risks and
benefits of participating in the medical surveillance program and the
employee's right to opt out of any or all parts of the medical
examination.
(ii) The employer must ensure that the employee is offered a
medical examination that includes:
(A) A medical and work history, with emphasis on past and present
airborne exposure to or dermal contact with beryllium, smoking history,
and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory system;
(C) A physical examination for skin rashes;
(D) Pulmonary function tests, performed in accordance with the
guidelines established by the American Thoracic Society including
forced vital capacity (FVC) and forced expiratory volume in one second
(FEV1);
(E) A standardized BeLPT or equivalent test, upon the first
examination and at least every two years thereafter, unless the
employee is confirmed positive. If the results of the BeLPT are other
than normal, a follow-up BeLPT must be offered within 30 days, unless
the employee has been confirmed positive. Samples must be analyzed in a
laboratory certified under the College of American Pathologists/
Clinical Laboratory Improvement Amendments (CLIA) guidelines to perform
the BeLPT.
(F) A low dose computed tomography (LDCT) scan, when recommended by
the PLHCP after considering the employee's history of exposure to
beryllium along with other risk factors, such as smoking history,
family medical history, sex, age, and presence of existing lung
disease; and
(G) Any other test deemed appropriate by the PLHCP.
(4) Information provided to the PLHCP. The employer must ensure
that the examining PLHCP (and the agreed-upon CBD diagnostic center, if
an evaluation is required under paragraph (k)(7) of this standard) has
a copy of this standard and must provide the following information, if
known:
(i) A description of the employee's former and current duties that
relate to the employee's airborne exposure to and dermal contact with
beryllium;
(ii) The employee's former and current levels of airborne exposure;
(iii) A description of any personal protective clothing and
equipment, including respirators, used by the employee, including when
and for how long the employee has used that personal protective
clothing and equipment; and
(iv) Information from records of employment-related medical
examinations previously provided to the employee, currently within the
control of the employer, after obtaining written consent from the
employee.
(5) Licensed physician's written medical report for the employee.
The employer must ensure that the employee receives a written medical
report from the licensed physician within 45 days of the examination
(including any follow-up BeLPT required under paragraph (k)(3)(ii)(E)
of this standard) and that the PLHCP explains the results of the
examination to the employee. The written medical report must contain:
(i) A statement indicating the results of the medical examination,
including the licensed physician's opinion as to whether the employee
has
(A) Any detected medical condition, such as CBD or beryllium
sensitization (i.e., the employee is confirmed positive, as defined in
paragraph (b) of this standard), that may place the employee at
increased risk from further airborne exposure, and
(B) Any medical conditions related to airborne exposure that
require further evaluation or treatment.
(ii) Any recommendations on:
(A) The employee's use of respirators, protective clothing, or
equipment; or
(B) Limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD
or if the licensed physician otherwise deems it appropriate, the
written report must also contain a referral for an evaluation at a CBD
diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD
the written report must also contain a recommendation for continued
periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD the
written report must also contain a recommendation for medical removal
from airborne exposure to beryllium, as described in paragraph (l) of
this standard.
(6) Licensed physician's written medical opinion for the employer.
(i) The employer must obtain a written medical opinion from the
licensed physician within 45 days of the medical examination (including
any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this
standard). The written medical opinion must contain only the following:
(A) The date of the examination;
(B) A statement that the examination has met the requirements of
this standard;
(C) Any recommended limitations on the employee's use of
respirators, protective clothing, or equipment; and
(D) A statement that the PLHCP has explained the results of the
medical examination to the employee, including any tests conducted, any
medical conditions related to airborne exposure that require further
evaluation or treatment, and any special provisions for use of personal
protective clothing or equipment;
(ii) If the employee provides written authorization, the written
opinion must also contain any recommended limitations on the employee's
airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD
or if the licensed physician otherwise deems it appropriate, and the
employee provides written authorization, the written opinion must also
contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD
and the employee provides written authorization, the written opinion
must also contain a recommendation for continued periodic medical
surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD and
the employee provides written authorization, the written opinion must
also contain a recommendation for medical removal from airborne
exposure to beryllium, as described in paragraph (l) of this standard.
(vi) The employer must ensure that each employee receives a copy of
the written medical opinion described in paragraph (k)(6) of this
standard within 45 days of any medical examination (including any
follow-up BeLPT required under paragraph (k)(3)(ii)(E) of
this standard) performed for that employee.
(7) CBD diagnostic center. (i) The employer must provide an
evaluation at no cost to the employee at a CBD diagnostic center that
is mutually agreed upon by the employer and the employee. The
examination must be provided within 30 days of:
(A) The employer's receipt of a physician's written medical opinion
to the employer that recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician's written
medical report indicating that the employee has been confirmed positive
or diagnosed with CBD, or recommending referral to a CBD diagnostic
center.
(ii) The employer must ensure that the employee receives a written
medical report from the CBD diagnostic center that contains all the
information required in paragraph (k)(5)(i), (ii), (iv), and (v) of
this standard and that the PLHCP explains the results of the
examination to the employee within 30 days of the examination.
(iii) The employer must obtain a written medical opinion from the
CBD diagnostic center within 30 days of the medical examination. The
written medical opinion must contain only the information in paragraph
(k)(6)(i), as applicable, unless the employee provides written
authorization to release additional information. If the employee
provides written authorization, the written opinion must also contain
the information from paragraphs (k)(6)(ii), (iv), and (v), if
applicable.
(iv) The employer must ensure that each employee receives a copy of
the written medical opinion from the CBD diagnostic center described in
paragraph (k)(7) of this standard within 30 days of any medical
examination performed for that employee.
(v) After an employee has received the initial clinical evaluation
at a CBD diagnostic center described in paragraph (k)(7)(i) of this
standard, the employee may choose to have any subsequent medical
examinations for which the employee is eligible under paragraph (k) of
this standard performed at a CBD diagnostic center mutually agreed upon
by the employer and the employee, and the employer must provide such
examinations at no cost to the employee.
(l) Medical removal. (1) An employee is eligible for medical
removal, if the employee works in a job with airborne exposure at or
above the action level and either:
(i) The employee provides the employer with:
(A) A written medical report indicating a confirmed positive
finding or CBD diagnosis; or
(B) A written medical report recommending removal from airborne
exposure to beryllium in accordance with paragraph (k)(5)(v) or
(k)(7)(ii) of this standard; or
(ii) The employer receives a written medical opinion recommending
removal from airborne exposure to beryllium in accordance with
paragraph (k)(6)(v) or (k)(7)(iii) of this standard.
(2) If an employee is eligible for medical removal, the employer
must provide the employee with the employee's choice of:
(i) Removal as described in paragraph (l)(3) of this standard; or
(ii) Remaining in a job with airborne exposure at or above the
action level, provided that the employer provides, and ensures that the
employee uses, respiratory protection that complies with paragraph (g)
of this standard whenever airborne exposures are at or above the action
level.
(3) If the employee chooses removal:
(i) If a comparable job is available where airborne exposures to
beryllium are below the action level, and the employee is qualified for
that job or can be trained within one month, the employer must remove
the employee to that job. The employer must maintain for six months
from the time of removal the employee's base earnings, seniority, and
other rights and benefits that existed at the time of removal.
(ii) If comparable work is not available, the employer must
maintain the employee's base earnings, seniority, and other rights and
benefits that existed at the time of removal for six months or until
such time that comparable work described in paragraph (l)(3)(i) becomes
available, whichever comes first.
(4) The employer's obligation to provide medical removal protection
benefits to a removed employee shall be reduced to the extent that the
employee receives compensation for earnings lost during the period of
removal from a publicly or employer-funded compensation program, or
receives income from another employer made possible by virtue of the
employee's removal.
(m) Communication of hazards--(1) General. (i) Chemical
manufacturers, importers, distributors, and employers must comply with
all requirements of the HCS (Sec. 1910.1200) for beryllium.
(ii) In classifying the hazards of beryllium, at least the
following hazards must be addressed: Cancer; lung effects (CBD and
acute beryllium disease); beryllium sensitization; skin sensitization;
and skin, eye, and respiratory tract irritation.
(iii) Employers must include beryllium in the hazard communication
program established to comply with the HCS. Employers must ensure that
each employee has access to labels on containers of beryllium and to
safety data sheets, and is trained in accordance with the requirements
of the HCS (Sec. 1910.1200) and paragraph (m)(4) of this standard.
(2) Warning signs. (i) Posting. The employer must provide and
display warning signs at each approach to a regulated area so that each
employee is able to read and understand the signs and take necessary
protective steps before entering the area.
(ii) Sign specification. (A) The employer must ensure that the
warning signs required by paragraph (m)(2)(i) of this standard are
legible and readily visible.
(B) The employer must ensure each warning sign required by
paragraph (m)(2)(i) of this standard bears the following legend:
DANGER
REGULATED AREA
BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PERSONAL PROTECTIVE CLOTHING AND
EQUIPMENT IN THIS AREA
(3) Warning labels. Consistent with the HCS (Sec. 1910.1200), the
employer must label each bag and container of clothing, equipment, and
materials contaminated with beryllium, and must, at a minimum, include
the following on the label:
DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN
(4) Employee information and training. (i) For each employee who
has, or can reasonably be expected to have, airborne exposure to or
dermal contact with beryllium:
(A) The employer must provide information and training in
accordance with the HCS (Sec. 1910.1200(h));
(B) The employer must provide initial training to each employee by
the time of initial assignment; and
(C) The employer must repeat the training required under this
standard annually for each employee.
(ii) The employer must ensure that each employee who is, or can
reasonably be expected to be, exposed to airborne beryllium can
demonstrate
knowledge and understanding of the following:
(A) The health hazards associated with airborne exposure to and
contact with beryllium, including the signs and symptoms of CBD;
(B) The written exposure control plan, with emphasis on the
location(s) of beryllium work areas, including any regulated areas, and
the specific nature of operations that could result in airborne
exposure, especially airborne exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and
limitations of personal protective clothing and equipment, including
respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from airborne
exposure to and contact with beryllium, including personal hygiene
practices;
(F) The purpose and a description of the medical surveillance
program required by paragraph (k) of this standard including risks and
benefits of each test to be offered;
(G) The purpose and a description of the medical removal protection
provided under paragraph (l) of this standard;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records
Access standard (Sec. 1910.1020).
(iii) When a workplace change (such as modification of equipment,
tasks, or procedures) results in new or increased airborne exposure
that exceeds, or can reasonably be expected to exceed, either the TWA
PEL or the STEL, the employer must provide additional training to those
employees affected by the change in airborne exposure.
(iv) Employee information. The employer must make a copy of this
standard and its appendices readily available at no cost to each
employee and designated employee representative(s).
(n) Recordkeeping--(1) Air monitoring data. (i) The employer must
make and maintain a record of all exposure measurements taken to assess
airborne exposure as prescribed in paragraph (d) of this standard.
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task that is being monitored;
(C) The sampling and analytical methods used and evidence of their
accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment,
including respirators, worn by monitored employees at the time of
monitoring; and
(F) The name, social security number, and job classification of
each employee represented by the monitoring, indicating which employees
were actually monitored.
(iii) The employer must ensure that exposure records are maintained
and made available in accordance with the Records Access standard
(Sec. 1910.1020).
(2) Objective data. (i) Where an employer uses objective data to
satisfy the exposure assessment requirements under paragraph (d)(2) of
this standard, the employer must make and maintain a record of the
objective data relied upon.
(ii) This record must include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(D) A description of the process, task, or activity on which the
objective data were based; and
(E) Other data relevant to the process, task, activity, material,
or airborne exposure on which the objective data were based.
(iii) The employer must ensure that objective data are maintained
and made available in accordance with the Records Access standard
(Sec. 1910.1020).
(3) Medical surveillance. (i) The employer must make and maintain a
record for each employee covered by medical surveillance under
paragraph (k) of this standard.
(ii) The record must include the following information about each
employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written medical opinions for
each employee; and
(C) A copy of the information provided to the PLHCP as required by
paragraph (k)(4) of this standard.
(iii) The employer must ensure that medical records are maintained
and made available in accordance with the Records Access standard
(Sec. 1910.1020).
(4) Training. (i) At the completion of any training required by
this standard, the employer must prepare a record that indicates the
name, social security number, and job classification of each employee
trained, the date the training was completed, and the topic of the
training.
(ii) This record must be maintained for three years after the
completion of training.
(5) Access to records. Upon request, the employer must make all
records maintained as a requirement of this standard available for
examination and copying to the Assistant Secretary, the Director, each
employee, and each employee's designated representative(s) in
accordance the Records Access standard (Sec. 1910.1020).
(6) Transfer of records. The employer must comply with the
requirements involving transfer of records set forth in the Records
Access standard (Sec. 1910.1020).
(o) Dates--(1) Effective date. This standard shall become effective
March 10, 2017.
(2) Compliance dates. All obligations of this standard commence and
become enforceable on March 12, 2018, except:
(i) Change rooms and showers required by paragraph (i) of this
standard must be provided by March 11, 2019; and
(ii) Engineering controls required by paragraph (f) of this
standard must be implemented by March 10, 2020.
(p) Appendix. Appendix A--Control Strategies to Minimize Beryllium
Exposure of this standard is non-mandatory.
Appendix A to Sec. 1910.1024--Control Strategies To Minimize Beryllium
Exposure (Non-Mandatory)
Paragraph (f)(2)(i) of this standard requires employers to use
one or more of the control methods listed in paragraph (f)(2)(i) to
minimize worker exposure in each operation in a beryllium work area,
unless the operation is exempt under paragraph (f)(2)(ii). This
appendix sets forth a non-exhaustive list of control options that
employers could use to comply with paragraph (f)(2)(i) for a number
of specific beryllium operations.
Table A.1--Exposure Control Recommendations
----------------------------------------------------------------------------------------------------------------
Operation Minimal control strategy * Application group
----------------------------------------------------------------------------------------------------------------
Beryllium Oxide Forming (e.g., pressing, For pressing operations:.................. Primary Beryllium
extruding). (1) Install local exhaust ventilation Production; Beryllium
(LEV) on oxide press tables, oxide feed Oxide Ceramics and
drum breaks, press tumblers, powder Composites.
rollers, and die set disassembly
stations;.
(2) Enclose the oxide presses; and........
(3) Install mechanical ventilation (make-
up air) in processing areas.
For extruding operations:
(1) Install LEV on extruder powder loading
hoods, oxide supply bottles, rod breaking
operations, centerless grinders, rod
laydown tables, dicing operations,
surface grinders, discharge end of
extrusion presses;.
(2) Enclose the centerless grinders; and..
(3) Install mechanical ventilation (make-
up air) in processing areas.
Chemical Processing Operations (e.g., For medium and high gassing operations:... Primary Beryllium
leaching, pickling, degreasing, (1) Perform operation with a hood having a Production; Beryllium
etching, plating). maximum of one open side; and. Oxide Ceramics and
(2) Design process so as to minimize Composites; Copper
spills; if accidental spills occur, Rolling, Drawing and
perform immediate cleanup. Extruding.
Finishing (e.g., grinding, sanding, (1) Perform portable finishing operations Secondary Smelting;
polishing, deburring). in a ventilated hood. The hood should Fabrication of Beryllium
include both downdraft and backdraft Alloy Products; Dental
ventilation, and have at least two sides Labs.
and a top.
(2) Perform stationary finishing
operations using a ventilated and
enclosed hood at the point of operation.
The grinding wheel of the stationary unit
should be enclosed and ventilated.
Furnace Operations (e.g., Melting and (1) Use LEV on furnaces, pelletizer; arc Primary Beryllium
Casting). furnace ingot machine discharge; pellet Production; Beryllium
sampling; arc furnace bins and conveyors; Oxide Ceramics and
beryllium hydroxide drum dumper and Composites; Nonferrous
dryer; furnace rebuilding; furnace tool Foundries; Secondary
holders; arc furnace tundish and tundish Smelting.
skimming, tundish preheat hood, and
tundish cleaning hoods; dross handling
equipment and drums; dross recycling; and
tool repair station, charge make-up
station, oxide screener, product sampling
locations, drum changing stations, and
drum cleaning stations
(2) Use mechanical ventilation (make-up
air) in furnace building.
Machining............................... Use (1) LEV consistent with ACGIH[supreg] Primary Beryllium
ventilation guidelines on deburring Production; Beryllium
hoods, wet surface grinder enclosures, Oxide Ceramics and
belt sanding hoods, and electrical Composites; Copper
discharge machines (for operations such Rolling, Drawing, and
as polishing, lapping, and buffing); Extruding; Precision
(2) high velocity low volume hoods or Turned Products.
ventilated enclosures on lathes, vertical
mills, CNC mills, and tool grinding
operations;.
(3) for beryllium oxide ceramics, LEV on
lapping, dicing, and laser cutting; and.
(4) wet methods (e.g., coolants)..........
Mechanical Processing (e.g., material (1) Enclose and ventilate sources of Primary Beryllium
handling (including scrap), sorting, emission; Production; Beryllium
crushing, screening, pulverizing, (2) Prohibit open handling of materials; Oxide Ceramics and
shredding, pouring, mixing, blending). and. Composites; Aluminum and
(3) Use mechanical ventilation (make-up Copper Foundries;
air) in processing areas. Secondary Smelting.
Metal Forming (e.g., rolling, drawing, (1) For rolling operations, install LEV on Primary Beryllium
straightening, annealing, extruding). mill stands and reels such that a hood Production; Copper
extends the length of the mill; Rolling, Drawing, and
(2) For point and chamfer operations, Extruding; Fabrication of
install LEV hoods at both ends of the Beryllium Alloy Products.
rod;.
(3) For annealing operations, provide an
inert atmosphere for annealing furnaces,
and LEV hoods at entry and exit points;.
(4) For swaging operations, install LEV on
the cutting head;.
(5) For drawing, straightening, and
extruding operations, install LEV at
entry and exit points; and.
(6) For all metal forming operations,
install mechanical ventilation (make-up
air) for processing areas.
Welding................................. For fixed welding operations:............. Primary Beryllium
(1) Enclose work locations around the Production; Fabrication
source of fume generation and use local of Beryllium Alloy
exhaust ventilation; and. Products; Welding.
(2) Install close capture hood enclosure
designed so as to minimize fume emission
from the enclosure welding operation..
For manual operations:....................
(1) Use portable local exhaust and general
ventilation.
----------------------------------------------------------------------------------------------------------------
* All LEV specifications should be in accordance with the ACGIH[supreg] Publication No. 2094, "Industrial
Ventilation--A Manual of Recommended Practice" wherever applicable.
PART 1915--OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD
EMPLOYMENT
0
4. The authority citation for part 1915 is revised to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754); 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912); 29 CFR part 1911; and 5 U.S.C. 553,
as applicable.
0
5. In Sec. 1915.1000 amend Table Z--Shipyards, by revising the entry
for "Beryllium and beryllium compounds (as Be)" and adding footnote
q.
The revisions read as follows:
* * * * *
Sec. 1915.1000 Air contaminants.
* * * * *
Table Z--Shipyards
----------------------------------------------------------------------------------------------------------------
Substance CAS No.d ppm a* mg/m3 b* Skin designation
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beryllium and beryllium compounds (as Be); 7440-41-7 .............. 0.002 ................
see 1915.1024 \(q)\........................
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be
determined from breathing-zone air samples.
\a\ Parts of vapor or gas per million parts of contaminated air by volume at 25 [deg]C and 760 torr.
\b\ Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when
listed with a ppm entry, it is approximate.
* * * * * * *
\d\ The CAS number is for information only. Enforcement is based on the substance name. For an entry covering
more than one metal compound, measured as the metal, the CAS number for the metal is given--not CAS numbers
for the individual compounds.
* * * * * * *
\q\ This standard applies to any operations or sectors for which the beryllium standard, 1915.1024, is stayed or
otherwise is not in effect.
* * * * *
0
6. Add Sec. 1915.1024 to read as follows:
Sec. 1915.1024 Beryllium.
(a) Scope and application. (1) This standard applies to
occupational exposure to beryllium in all forms, compounds, and
mixtures in shipyards, except those articles and materials exempted by
paragraphs (a)(2) and (a)(3) of this standard.
(2) This standard does not apply to articles, as defined in the
Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain
beryllium and that the employer does not process.
(3) This standard does not apply to materials containing less than
0.1% beryllium by weight where the employer has objective data
demonstrating that employee exposure to beryllium will remain below the
action level as an 8-hour TWA under any foreseeable conditions.
(b) Definitions. As used in this standard:
Action level means a concentration of airborne beryllium of 0.1
micrograms per cubic meter of air (μg/m3\) calculated as an 8-hour
time-weighted average (TWA).
Airborne exposure and airborne exposure to beryllium mean the
exposure to airborne beryllium that would occur if the employee were
not using a respirator.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, United States Department of Labor, or
designee.
Beryllium lymphocyte proliferation test (BeLPT) means the
measurement of blood lymphocyte proliferation in a laboratory test when
lymphocytes are challenged with a soluble beryllium salt.
CBD diagnostic center means a medical diagnostic center that has an
on-site pulmonary specialist and on-site facilities to perform a
clinical evaluation for the presence of chronic beryllium disease
(CBD). This evaluation must include pulmonary function testing (as
outlined by the American Thoracic Society criteria), bronchoalveolar
lavage (BAL), and transbronchial biopsy. The CBD diagnostic center must
also have the capacity to transfer BAL samples to a laboratory for
appropriate diagnostic testing within 24 hours. The on-site pulmonary
specialist must be able to interpret the biopsy pathology and the BAL
diagnostic test results.
Chronic beryllium disease (CBD) means a chronic lung disease
associated with airborne exposure to beryllium.
Confirmed positive means the person tested has beryllium
sensitization, as indicated by two abnormal BeLPT test results, an
abnormal and a borderline test result, or three borderline test
results. It also means the result of a more reliable and accurate test
indicating a person has been identified as having beryllium
sensitization.
Director means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee.
Emergency means any uncontrolled release of airborne beryllium.
High-efficiency particulate air (HEPA) filter means a filter that
is at least 99.97 percent efficient in removing particles 0.3
micrometers in diameter.
Objective data means information, such as air monitoring data from
industry-wide surveys or calculations based on the composition of a
substance, demonstrating airborne exposure to beryllium associated with
a particular product or material or a specific process, task, or
activity. The data must reflect workplace conditions closely resembling
or with a higher airborne exposure potential than the processes, types
of material, control methods, work practices, and environmental
conditions in the employer's current operations.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services required by paragraph (k) of this standard.
Regulated area means an area, including temporary work areas where
maintenance or non-routine tasks are performed, where an employee's
airborne exposure exceeds, or can reasonably be expected to exceed,
either the time-weighted average (TWA) permissible exposure limit (PEL)
or short term exposure limit (STEL).
This standard means this beryllium standard, 29 CFR 1915.1024.
(c) Permissible Exposure Limits (PELs)--(1) Time-weighted average
(TWA) PEL. The employer must ensure that no employee is exposed to an
airborne concentration of beryllium in excess of 0.2 μg/m3\
calculated as an 8-hour TWA.
(2) Short-term exposure limit (STEL). The employer must ensure that
no employee is exposed to an airborne concentration of beryllium in
excess of 2.0 μg/m3\ as determined over a sampling period of 15
minutes.
(d) Exposure assessment--(1) General. The employer must assess the
airborne exposure of each employee who is or may reasonably be expected
to be exposed to airborne beryllium in accordance with either the
performance option in paragraph (d)(2) or the scheduled monitoring
option in paragraph (d)(3) of this standard.
(2) Performance option. The employer must assess the 8-hour TWA
exposure and the 15-minute short-term exposure for each employee on the
basis of any combination of air monitoring data and objective data
sufficient to accurately characterize airborne exposure to beryllium.
(3) Scheduled monitoring option. (i) The employer must perform
initial monitoring to assess the 8-hour TWA exposure for each employee
on the basis of one or more personal breathing zone air samples that
reflect the airborne exposure of employees on each shift, for each job
classification, and in each work area.
(ii) The employer must perform initial monitoring to assess the
short-term exposure from 15-minute personal breathing zone air samples
measured in operations that are likely to produce airborne exposure
above the STEL for each work shift, for each job classification, and in
each work area.
(iii) Where several employees perform the same tasks on the same
shift and in the same work area, the employer may sample a
representative fraction of these employees in order to meet the
requirements of paragraph (d)(3) of this standard. In representative
sampling, the employer must sample the employee(s) expected to have the
highest airborne exposure to beryllium.
(iv) If initial monitoring indicates that airborne exposure is
below the action level and at or below the STEL, the employer may
discontinue monitoring for those employees whose airborne exposure is
represented by such monitoring.
(v) Where the most recent exposure monitoring indicates that
airborne exposure is at or above the action level but at or below the
TWA PEL, the employer must repeat such monitoring within six months of
the most recent monitoring.
(vi) Where the most recent exposure monitoring indicates that
airborne exposure is above the TWA PEL, the employer must repeat such
monitoring within three months of the most recent 8-hour TWA exposure
monitoring.
(vii) Where the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the action level, the
employer must repeat such monitoring within six months of the most
recent monitoring until two consecutive measurements, taken 7 or more
days apart, are below the action level, at which time the employer may
discontinue 8-hour TWA exposure monitoring for those employees whose
exposure is represented by such monitoring, except as otherwise
provided in paragraph (d)(4) of this standard.
(viii) Where the most recent exposure monitoring indicates that
airborne exposure is above the STEL, the employer must repeat such
monitoring within three months of the most recent short-term exposure
monitoring until two consecutive measurements, taken 7 or more days
apart, are below the STEL, at which time the employer may discontinue
short-term exposure monitoring for those employees whose exposure is
represented by such monitoring, except as otherwise provided in
paragraph (d)(4) of this standard.
(4) Reassessment of exposure. The employer must reassess airborne
exposure whenever a change in the production, process, control
equipment, personnel, or work practices may reasonably be expected to
result in new or additional airborne exposure at or above the action
level or STEL, or when the employer has any reason to believe that new
or additional airborne exposure at or above the action level or STEL
has occurred.
(5) Methods of sample analysis. The employer must ensure that all
air monitoring samples used to satisfy the monitoring requirements of
paragraph (d) of this standard are evaluated by a laboratory that can
measure beryllium to an accuracy of plus or minus 25 percent within a
statistical confidence level of 95 percent for airborne concentrations
at or above the action level.
(6) Employee notification of assessment results. (i) Within 15
working days after completing an exposure assessment in accordance with
paragraph (d) of this standard, the employer must notify each employee
whose airborne exposure is represented by the assessment of the results
of that assessment individually in writing or post the results in an
appropriate location that is accessible to each of these employees.
(ii) Whenever an exposure assessment indicates that airborne
exposure is above the TWA PEL or STEL, the employer must describe in
the written notification the corrective action being taken to reduce
airborne exposure to or below the exposure limit(s) exceeded where
feasible corrective action exists but had not been implemented when the
monitoring was conducted.
(7) Observation of monitoring. (i) The employer must provide an
opportunity to observe any exposure monitoring required by this
standard to each employee whose airborne exposure is measured or
represented by the monitoring and each employee's representative(s).
(ii) When observation of monitoring requires entry into an area
where the use of personal protective clothing or equipment (which may
include respirators) is required, the employer must provide each
observer with appropriate personal protective clothing and equipment at
no cost to the observer and must ensure that each observer uses such
clothing and equipment.
(iii) The employer must ensure that each observer follows all other
applicable safety and health procedures.
(e) Regulated areas--(1) Establishment. The employer must establish
and maintain a regulated area wherever employees are, or can reasonably
be expected to be, exposed to airborne beryllium at levels above the
TWA PEL or STEL.
(2) Demarcation. The employer must identify each regulated area in
accordance with paragraph (m)(2) of this standard.
(3) Access. The employer must limit access to regulated areas to:
(i) Persons the employer authorizes or requires to be in a
regulated area to perform work duties;
(ii) Persons entering a regulated area as designated
representatives of employees for the purpose of exercising the right to
observe exposure monitoring procedures under paragraph (d)(7) of this
standard; and
(iii) Persons authorized by law to be in a regulated area.
(4) Provision of personal protective clothing and equipment,
including respirators. The employer must provide and ensure that each
employee entering a regulated area uses:
(i) Respiratory protection in accordance with paragraph (g) of this
standard; and
(ii) Personal protective clothing and equipment in accordance with
paragraph (h) of this standard.
(f) Methods of compliance--(1) Written exposure control plan. (i)
The employer must establish, implement, and maintain a written exposure
control plan, which must contain:
(A) A list of operations and job titles reasonably expected to
involve airborne exposure to or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to
involve airborne exposure at or above the action level;
(C) A list of operations and job titles reasonably expected to
involve airborne exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination;
(E) Procedures for minimizing the migration of beryllium within or
to locations outside the workplace;
(F) A list of engineering controls, work practices, and respiratory
protection required by paragraph (f)(2) of this standard;
(G) A list of personal protective clothing and equipment required
by paragraph (h) of this standard; and
(H) Procedures for removing, laundering, storing, cleaning,
repairing, and disposing of beryllium-contaminated personal protective
clothing and equipment, including respirators.
(ii) The employer must review and evaluate the effectiveness of
each written exposure control plan at least annually and update it, as
necessary, when:
(A) Any change in production processes, materials, equipment,
personnel, work practices, or control methods results, or can
reasonably be expected to result, in new or additional airborne
exposure to beryllium;
(B) The employer is notified that an employee is eligible for
medical removal in accordance with paragraph (l)(1) of this standard,
referred for evaluation at a CBD diagnostic center, or shows signs or
symptoms associated with airborne exposure to or dermal contact with
beryllium; or
(C) The employer has any reason to believe that new or additional
airborne exposure is occurring or will occur.
(iii) The employer must make a copy of the written exposure control
plan accessible to each employee who is, or can reasonably be expected
to be, exposed to airborne beryllium in accordance with OSHA's Access
to Employee Exposure and Medical Records (Records Access) standard (29
CFR 1910.1020(e)).
(2) Engineering and work practice controls. (i) Where exposures
are, or can reasonably be expected to be, at or above the action level,
the employer must ensure that at least one of the following is in place
to reduce airborne exposure:
(A) Material and/or process substitution;
(B) Isolation, such as ventilated partial or full enclosures;
(C) Local exhaust ventilation, such as at the points of operation,
material handling, and transfer; or
(D) Process control, such as wet methods and automation.
(ii) An employer is exempt from using the controls listed in
paragraph (f)(2)(i) of this standard to the extent that:
(A) The employer can establish that such controls are not feasible;
or
(B) The employer can demonstrate that airborne exposure is below
the action level, using no fewer than two representative personal
breathing zone samples taken at least 7 days apart, for each affected
operation.
(iii) If airborne exposure exceeds the TWA PEL or STEL after
implementing the control(s) required by (f)(2)(i), the employer must
implement additional or enhanced engineering and work practice controls
to reduce airborne exposure to or below the exposure limit(s) exceeded.
(iv) Wherever the employer demonstrates that it is not feasible to
reduce airborne exposure to or below the PELs by the engineering and
work practice controls required by paragraphs (f)(2)(i) and
(f)(2)(iii), the employer must implement and maintain engineering and
work practice controls to reduce airborne exposure to the lowest levels
feasible and supplement these controls by using respiratory protection
in accordance with paragraph (g) of this standard.
(3) Prohibition of rotation. The employer must not rotate employees
to different jobs to achieve compliance with the PELs.
(g) Respiratory protection--(1) General. The employer must provide
respiratory protection at no cost to the employee and ensure that each
employee uses respiratory protection:
(i) During periods necessary to install or implement feasible
engineering and work practice controls where airborne exposure exceeds,
or can reasonably be expected to exceed, the TWA PEL or STEL;
(ii) During operations, including maintenance and repair activities
and non-routine tasks, when engineering and work practice controls are
not feasible and airborne exposure exceeds, or can reasonably be
expected to exceed, the TWA PEL or STEL;
(iii) During operations for which an employer has implemented all
feasible engineering and work practice controls when such controls are
not sufficient to reduce airborne exposure to or below the TWA PEL or
STEL;
(iv) During emergencies; and
(v) When an employee who is eligible for medical removal under
paragraph (l)(1) chooses to remain in a job with airborne exposure at
or above the action level, as permitted by paragraph (l)(2)(ii).
(2) Respiratory protection program. Where this standard requires an
employer to provide respiratory protection, the selection and use of
such respiratory protection must be in accordance with the Respiratory
Protection standard (29 CFR 1910.134).
(3) The employer must provide at no cost to the employee a powered
air-purifying respirator (PAPR) instead of a negative pressure
respirator when
(i) Respiratory protection is required by this standard;
(ii) An employee entitled to such respiratory protection requests a
PAPR; and
(iii) The PAPR provides adequate protection to the employee in
accordance with paragraph (g)(2) of this standard.
(h) Personal protective clothing and equipment--(1) Provision and
use. The employer must provide at no cost, and ensure that each
employee uses, appropriate personal protective clothing and equipment
in accordance with the written exposure control plan required under
paragraph (f)(1) of this standard and OSHA's Personal Protective
Equipment standards for shipyards (subpart I of this part):
(i) Where airborne exposure exceeds, or can reasonably be expected
to exceed, the TWA PEL or STEL; or
(ii) Where there is a reasonable expectation of dermal contact with
beryllium.
(2) Removal and storage. (i) The employer must ensure that each
employee removes all beryllium-contaminated personal protective
clothing and equipment at the end of the work shift, at the completion
of tasks involving beryllium, or when personal protective clothing or
equipment becomes visibly contaminated with beryllium, whichever comes
first.
(ii) The employer must ensure that each employee removes beryllium-
contaminated personal protective clothing and equipment as specified in
the written exposure control plan required by paragraph (f)(1) of this
standard.
(iii) The employer must ensure that each employee stores and keeps
beryllium-contaminated personal
protective clothing and equipment separate from street clothing and
that storage facilities prevent cross-contamination as specified in the
written exposure control plan required by paragraph (f)(1) of this
standard.
(iv) The employer must ensure that no employee removes beryllium-
contaminated personal protective clothing or equipment from the
workplace, except for employees authorized to do so for the purposes of
laundering, cleaning, maintaining or disposing of beryllium-
contaminated personal protective clothing and equipment at an
appropriate location or facility away from the workplace.
(v) When personal protective clothing or equipment required by this
standard is removed from the workplace for laundering, cleaning,
maintenance or disposal, the employer must ensure that personal
protective clothing and equipment are stored and transported in sealed
bags or other closed containers that are impermeable and are labeled in
accordance with paragraph (m)(3) of this standard and the HCS (29 CFR
1910.1200).
(3) Cleaning and replacement. (i) The employer must ensure that all
reusable personal protective clothing and equipment required by this
standard is cleaned, laundered, repaired, and replaced as needed to
maintain its effectiveness.
(ii) The employer must ensure that beryllium is not removed from
personal protective clothing and equipment by blowing, shaking or any
other means that disperses beryllium into the air.
(iii) The employer must inform in writing the persons or the
business entities who launder, clean or repair the personal protective
clothing or equipment required by this standard of the potentially
harmful effects of airborne exposure to and dermal contact with
beryllium and that the personal protective clothing and equipment must
be handled in accordance with this standard.
(i) Hygiene areas and practices--(1) General. For each employee
required to use personal protective clothing or equipment by this
standard, the employer must:
(i) Provide readily accessible washing facilities in accordance
with this standard and the Sanitation standard (Sec. 1915.88) to
remove beryllium from the hands, face, and neck; and
(ii) Ensure that employees who have dermal contact with beryllium
wash any exposed skin at the end of the activity, process, or work
shift and prior to eating, drinking, smoking, chewing tobacco or gum,
applying cosmetics, or using the toilet.
(2) Change rooms. In addition to the requirements of paragraph
(i)(1)(i) of this standard, the employer must provide employees
required to use personal protective clothing by this standard with a
designated change room in accordance with the Sanitation standard
(Sec. 1915.88) where employees are required to remove their personal
clothing.
(3) Eating and drinking areas. Wherever the employer allows
employees to consume food or beverages at a worksite where beryllium is
present, the employer must ensure that:
(i) Surfaces in eating and drinking areas are as free as
practicable of beryllium;
(ii) No employees enter any eating or drinking area with personal
protective clothing or equipment unless, prior to entry, surface
beryllium has been removed from the clothing or equipment by methods
that do not disperse beryllium into the air or onto an employee's body;
and
(iii) Eating and drinking facilities provided by the employer are
in accordance with the Sanitation standard (29 CFR 1915.88).
(4) Prohibited activities. The employer must ensure that no
employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in
regulated areas.
(j) Housekeeping--(1) General. (i) When cleaning beryllium-
contaminated areas, the employer must follow the written exposure
control plan required under paragraph (f)(1) of this standard; and
(ii) The employer must ensure that all spills and emergency
releases of beryllium are cleaned up promptly and in accordance with
the written exposure control plan required under paragraph (f)(1).
(2) Cleaning methods. (i) When cleaning beryllium-contaminated
areas, the employer must ensure the use of HEPA-filtered vacuuming or
other methods that minimize the likelihood and level of airborne
exposure.
(ii) The employer must not allow dry sweeping or brushing for
cleaning in beryllium-contaminated areas unless HEPA-filtered vacuuming
or other methods that minimize the likelihood and level of airborne
exposure are not safe or effective.
(iii) The employer must not allow the use of compressed air for
cleaning in beryllium-contaminated areas unless the compressed air is
used in conjunction with a ventilation system designed to capture the
particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air
to clean in beryllium-contaminated areas, the employer must provide,
and ensure that each employee uses, respiratory protection and personal
protective clothing and equipment in accordance with paragraphs (g) and
(h) of this standard.
(v) The employer must ensure that cleaning equipment is handled and
maintained in a manner that minimizes the likelihood and level of
airborne exposure and the re-entrainment of airborne beryllium in the
workplace.
(3) Disposal. When the employer transfers materials containing
beryllium to another party for use or disposal, the employer must
provide the recipient with a copy of the warning described in paragraph
(m)(3) of this standard.
(k) Medical surveillance--(1) General. (i) The employer must make
medical surveillance required by this paragraph available at no cost to
the employee, and at a reasonable time and place, to each employee:
(A) Who is or is reasonably expected to be exposed at or above the
action level for more than 30 days per year;
(B) Who shows signs or symptoms of CBD or other beryllium-related
health effects;
(C) Who is exposed to beryllium during an emergency; or
(D) Whose most recent written medical opinion required by paragraph
(k)(6) or (k)(7) recommends periodic medical surveillance.
(ii) The employer must ensure that all medical examinations and
procedures required by this standard are performed by, or under the
direction of, a licensed physician.
(2) Frequency. The employer must provide a medical examination:
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A) of
this standard, unless the employee has received a medical examination,
provided in accordance with this standard, within the last two years;
or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or (C)
of this standard.
(ii) At least every two years thereafter for each employee who
continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D)
of this standard.
(iii) At the termination of employment for each employee who meets
any of the criteria of paragraph (k)(1)(i) of this standard at the time
the employee's employment terminates, unless an examination has been
provided in accordance with this standard during the six months prior
to the date of termination.
(3) Contents of examination. (i) The employer must ensure that the
PLHCP conducting the examination advises the employee of the risks and
benefits of participating in the medical surveillance program and the
employee's right to opt out of any or all parts of the medical
examination.
(ii) The employer must ensure that the employee is offered a
medical examination that includes:
(A) A medical and work history, with emphasis on past and present
airborne exposure to or dermal contact with beryllium, smoking history,
and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory system;
(C) A physical examination for skin rashes;
(D) Pulmonary function tests, performed in accordance with the
guidelines established by the American Thoracic Society including
forced vital capacity (FVC) and forced expiratory volume in one second
(FEV1);
(E) A standardized BeLPT or equivalent test, upon the first
examination and at least every two years thereafter, unless the
employee is confirmed positive. If the results of the BeLPT are other
than normal, a follow-up BeLPT must be offered within 30 days, unless
the employee has been confirmed positive. Samples must be analyzed in a
laboratory certified under the College of American Pathologists/
Clinical Laboratory Improvement Amendments (CLIA) guidelines to perform
the BeLPT.
(F) A low dose computed tomography (LDCT) scan, when recommended by
the PLHCP after considering the employee's history of exposure to
beryllium along with other risk factors, such as smoking history,
family medical history, sex, age, and presence of existing lung
disease; and
(G) Any other test deemed appropriate by the PLHCP.
(4) Information provided to the PLHCP. The employer must ensure
that the examining PLHCP (and the agreed-upon CBD diagnostic center, if
an evaluation is required under paragraph (k)(7) of this standard) has
a copy of this standard and must provide the following information, if
known:
(i) A description of the employee's former and current duties that
relate to the employee's airborne exposure to and dermal contact with
beryllium;
(ii) The employee's former and current levels of airborne exposure;
(iii) A description of any personal protective clothing and
equipment, including respirators, used by the employee, including when
and for how long the employee has used that personal protective
clothing and equipment; and
(iv) Information from records of employment-related medical
examinations previously provided to the employee, currently within the
control of the employer, after obtaining written consent from the
employee.
(5) Licensed physician's written medical report for the employee.
The employer must ensure that the employee receives a written medical
report from the licensed physician within 45 days of the examination
(including any follow-up BeLPT required under paragraph (k)(3)(ii)(E)
of this standard) and that the PLHCP explains the results of the
examination to the employee. The written medical report must contain:
(i) A statement indicating the results of the medical examination,
including the licensed physician's opinion as to whether the employee
has
(A) Any detected medical condition, such as CBD or beryllium
sensitization (i.e., the employee is confirmed positive, as defined in
paragraph (b) of this standard), that may place the employee at
increased risk from further airborne exposure, and
(B) Any medical conditions related to airborne exposure that
require further evaluation or treatment.
(ii) Any recommendations on:
(A) The employee's use of respirators, protective clothing, or
equipment; or
(B) Limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD
or if the licensed physician otherwise deems it appropriate, the
written report must also contain a referral for an evaluation at a CBD
diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD
the written report must also contain a recommendation for continued
periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD the
written report must also contain a recommendation for medical removal
from airborne exposure to beryllium, as described in paragraph (l).
(6) Licensed physician's written medical opinion for the employer.
(i) The employer must obtain a written medical opinion from the
licensed physician within 45 days of the medical examination (including
any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this
standard). The written medical opinion must contain only the following:
(A) The date of the examination;
(B) A statement that the examination has met the requirements of
this standard;
(C) Any recommended limitations on the employee's use of
respirators, protective clothing, or equipment; and
(D) A statement that the PLHCP has explained the results of the
medical examination to the employee, including any tests conducted, any
medical conditions related to airborne exposure that require further
evaluation or treatment, and any special provisions for use of personal
protective clothing or equipment;
(ii) If the employee provides written authorization, the written
opinion must also contain any recommended limitations on the employee's
airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD
or if the licensed physician otherwise deems it appropriate, and the
employee provides written authorization, the written opinion must also
contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD
and the employee provides written authorization, the written opinion
must also contain a recommendation for continued periodic medical
surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD and
the employee provides written authorization, the written opinion must
also contain a recommendation for medical removal from airborne
exposure to beryllium, as described in paragraph (l).
(vi) The employer must ensure that each employee receives a copy of
the written medical opinion described in paragraph (k)(6) of this
standard within 45 days of any medical examination (including any
follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this
standard) performed for that employee.
(7) CBD diagnostic center. (i) The employer must provide an
evaluation at no cost to the employee at a CBD diagnostic center that
is mutually agreed upon by the employer and the employee. The
examination must be provided within 30 days of:
(A) The employer's receipt of a physician's written medical opinion
to the employer that recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician's written
medical report indicating that the employee has been confirmed positive
or diagnosed with CBD, or recommending referral to a CBD diagnostic
center.
(ii) The employer must ensure that the employee receives a written
medical report from the CBD diagnostic center that contains all the
information required in paragraph (k)(5)(i), (ii), (iv), and (v) and
that the PLHCP explains the results of the examination to the employee
within 30 days of the examination.
(iii) The employer must obtain a written medical opinion from the
CBD diagnostic center within 30 days of the medical examination. The
written medical opinion must contain only the information in paragraphs
(k)(6)(i), as applicable, unless the employee provides written
authorization to release additional information. If the employee
provides written authorization, the written opinion must also contain
the information from paragraphs (k)(6)(ii), (iv), and (v), if
applicable.
(iv) The employer must ensure that each employee receives a copy of
the written medical opinion from the CBD diagnostic center described in
paragraph (k)(7) of this standard within 30 days of any medical
examination performed for that employee.
(v) After an employee has received the initial clinical evaluation
at a CBD diagnostic center described in paragraph (k)(7)(i) of this
standard, the employee may choose to have any subsequent medical
examinations for which the employee is eligible under paragraph (k) of
this standard performed at a CBD diagnostic center mutually agreed upon
by the employer and the employee, and the employer must provide such
examinations at no cost to the employee.
(l) Medical removal. (1) An employee is eligible for medical
removal, if the employee works in a job with airborne exposure at or
above the action level and either:
(i) The employee provides the employer with:
(A) A written medical report indicating a confirmed positive
finding or CBD diagnosis; or
(B) A written medical report recommending removal from airborne
exposure to beryllium in accordance with paragraph (k)(5)(v) or
(k)(7)(ii) of this standard; or
(ii) The employer receives a written medical opinion recommending
removal from airborne exposure to beryllium in accordance with
paragraph (k)(6)(v) or (k)(7)(iii) of this standard.
(2) If an employee is eligible for medical removal, the employer
must provide the employee with the employee's choice of:
(i) Removal as described in paragraph (l)(3) of this standard; or
(ii) Remaining in a job with airborne exposure at or above the
action level, provided that the employer provides, and ensures that the
employee uses, respiratory protection that complies with paragraph (g)
of this standard whenever airborne exposures are at or above the action
level.
(3) If the employee chooses removal:
(i) If a comparable job is available where airborne exposures to
beryllium are below the action level, and the employee is qualified for
that job or can be trained within one month, the employer must remove
the employee to that job. The employer must maintain for six months
from the time of removal the employee's base earnings, seniority, and
other rights and benefits that existed at the time of removal.
(ii) If comparable work is not available, the employer must
maintain the employee's base earnings, seniority, and other rights and
benefits that existed at the time of removal for six months or until
such time that comparable work described in paragraph (l)(3)(i) becomes
available, whichever comes first.
(4) The employer's obligation to provide medical removal protection
benefits to a removed employee shall be reduced to the extent that the
employee receives compensation for earnings lost during the period of
removal from a publicly or employer-funded compensation program, or
receives income from another employer made possible by virtue of the
employee's removal.
(m) Communication of hazards--(1) General. (i) Chemical
manufacturers, importers, distributors, and employers must comply with
all requirements of the HCS (29 CFR 1910.1200) for beryllium.
(ii) Employers must include beryllium in the hazard communication
program established to comply with the HCS. Employers must ensure that
each employee has access to labels on containers of beryllium and to
safety data sheets, and is trained in accordance with the requirements
of the HCS (29 CFR 1910.1200) and paragraph (m)(4) of this standard.
(2) Warning signs. (i) Posting. The employer must provide and
display warning signs at each approach to a regulated area so that each
employee is able to read and understand the signs and take necessary
protective steps before entering the area.
(ii) Sign specification. (A) The employer must ensure that the
warning signs required by paragraph (m)(2)(i) of this standard are
legible and readily visible.
(B) The employer must ensure each warning sign required by
paragraph (m)(2)(i) of this standard bears the following legend:
DANGER
REGULATED AREA
BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PERSONAL PROTECTIVE CLOTHING AND
EQUIPMENT IN THIS AREA
(3) Warning labels. Consistent with the HCS (29 CFR 1910.1200), the
employer must label each bag and container of clothing, equipment, and
materials contaminated with beryllium, and must, at a minimum, include
the following on the label:
DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN
(4) Employee information and training. (i) For each employee who
has, or can reasonably be expected to have, airborne exposure to or
dermal contact with beryllium:
(A) The employer must provide information and training in
accordance with the HCS (29 CFR 1910.1200(h));
(B) The employer must provide initial training to each employee by
the time of initial assignment; and
(C) The employer must repeat the training required under this
standard annually for each employee.
(ii) The employer must ensure that each employee who is, or can
reasonably be expected to be, exposed to airborne beryllium can
demonstrate knowledge and understanding of the following:
(A) The health hazards associated with airborne exposure to and
contact with beryllium, including the signs and symptoms of CBD;
(B) The written exposure control plan, with emphasis on the
location(s) of any regulated areas, and the specific nature of
operations that could result in airborne exposure, especially airborne
exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and
limitations of personal protective clothing and equipment, including
respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from airborne
exposure to and contact with beryllium, including personal hygiene
practices;
(F) The purpose and a description of the medical surveillance
program required by paragraph (k) of this
standard including risks and benefits of each test to be offered;
(G) The purpose and a description of the medical removal protection
provided under paragraph (l) of this standard;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records
Access standard (29 CFR 1910.1020).
(iii) When a workplace change (such as modification of equipment,
tasks, or procedures) results in new or increased airborne exposure
that exceeds, or can reasonably be expected to exceed, either the TWA
PEL or the STEL, the employer must provide additional training to those
employees affected by the change in airborne exposure.
(iv) Employee information. The employer must make a copy of this
standard and its appendices readily available at no cost to each
employee and designated employee representative(s).
(n) Recordkeeping--(1) Air monitoring data. (i) The employer must
make and maintain a record of all exposure measurements taken to assess
airborne exposure as prescribed in paragraph (d) of this standard.
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task that is being monitored;
(C) The sampling and analytical methods used and evidence of their
accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment,
including respirators, worn by monitored employees at the time of
monitoring; and
(F) The name, social security number, and job classification of
each employee represented by the monitoring, indicating which employees
were actually monitored.
(iii) The employer must ensure that exposure records are maintained
and made available in accordance with the Records Access standard (29
CFR 1910.1020).
(2) Objective data. (i) Where an employer uses objective data to
satisfy the exposure assessment requirements under paragraph (d)(2) of
this standard, the employer must make and maintain a record of the
objective data relied upon.
(ii) This record must include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(D) A description of the process, task, or activity on which the
objective data were based; and
(E) Other data relevant to the process, task, activity, material,
or airborne exposure on which the objective data were based.
(iii) The employer must ensure that objective data are maintained
and made available in accordance with the Records Access standard (29
CFR 1910.1020).
(3) Medical surveillance. (i) The employer must make and maintain a
record for each employee covered by medical surveillance under
paragraph (k) of this standard.
(ii) The record must include the following information about each
employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written medical opinions for
each employee; and
(C) A copy of the information provided to the PLHCP as required by
paragraph (k)(4) of this standard.
(iii) The employer must ensure that medical records are maintained
and made available in accordance with the Records Access standard (29
CFR 1910.1020).
(4) Training. (i) At the completion of any training required by
this standard, the employer must prepare a record that indicates the
name, social security number, and job classification of each employee
trained, the date the training was completed, and the topic of the
training.
(ii) This record must be maintained for three years after the
completion of training.
(5) Access to records. Upon request, the employer must make all
records maintained as a requirement of this standard available for
examination and copying to the Assistant Secretary, the Director, each
employee, and each employee's designated representative(s) in
accordance the Records Access standard (29 CFR 1910.1020).
(6) Transfer of records. The employer must comply with the
requirements involving transfer of records set forth in the Records
Access standard (29 CFR 1910.1020).
(o) Dates--(1) Effective date. This standard shall become effective
March 10, 2017.
(2) Compliance dates. All obligations of this standard commence and
become enforceable on March 12, 2018, except:
(i) Change rooms required by paragraph (i) of this standard must be
provided by March 11, 2019; and
(ii) Engineering controls required by paragraph (f) of this
standard must be implemented by March 10, 2020.
PART 1926--SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION
Subpart D--Occupational Health and Environmental Controls
0
7. The authority citation for subpart D of part 1926 is revised to read
as follows:
Authority: 40 U.S.C. 3704; 29 U.S.C. 653, 655, 657; Secretary
of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83
(48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912); 29 CFR part 1911; and 5 U.S.C. 553,
as applicable.
Section 1926.61 also issued under 49 U.S.C. 5101 et seq.
Section 1926.62 also issued under 42 U.S.C. 4853.
Section 1926.65 also issued under 126 of Public Law 99-499, 100
Stat. 1613.
0
8. In Sec. 1926.55, amend appendix A by revising the entry for
"Beryllium and beryllium compounds (as Be)" and adding footnote q.
The revisions read as follows:
Sec. 1926.55 Gases, vapors, fumes, dusts, and mists.
* * * * *
Appendix A to Sec. 1926.55--1970 American Conference of Governmental
Industrial Hygienists' Threshold Limit Values of Airborne Contaminants
Threshold Limit Values of Airborne Contaminants for Construction
----------------------------------------------------------------------------------------------------------------
Substance CAS No.\d\ ppm a* mg/m 3b Skin designation
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beryllium and beryllium compounds (as Be); 7440-41-7 ............... 0.002 ................
see 1926.1124 \(q)\.......................
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Parts of vapor or gas per million parts of contaminated air by volume at 25 [deg]C and 760 torr.
\b\ Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when
listed with a ppm entry, it is approximate.
* * * * * * *
\d\ The CAS number is for information only. Enforcement is based on the substance name. For an entry covering
more than one metal compound, measured as the metal, the CAS number for the metal is given--not CAS numbers
for the individual compounds.
* * * * * * *
\q\ This standard applies to any operations or sectors for which the beryllium standard, 1926.1124, is stayed or
otherwise is not in effect.
* * * * *
Subpart Z--Toxic and Hazardous Substances
0
9. The authority for subpart Z of part 1926 is revised to read as
follows:
Authority: 40 U.S.C. 3704; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912); 29 CFR part 1911; and 5 U.S.C. 553,
as applicable.
0
10. Add Sec. 1926.1124 to read as follows:
Sec. 1926.1124 Beryllium.
(a) Scope and application. (1) This standard applies to
occupational exposure to beryllium in all forms, compounds, and
mixtures in construction, except those articles and materials exempted
by paragraphs (a)(2) and (a)(3) of this standard.
(2) This standard does not apply to articles, as defined in the
Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain
beryllium and that the employer does not process.
(3) This standard does not apply to materials containing less than
0.1% beryllium by weight where the employer has objective data
demonstrating that employee exposure to beryllium will remain below the
action level as an 8-hour TWA under any foreseeable conditions.
(b) Definitions. As used in this standard:
Action level means a concentration of airborne beryllium of 0.1
micrograms per cubic meter of air (μg/m3\) calculated as an 8-hour
time-weighted average (TWA).
Airborne exposure and airborne exposure to beryllium mean the
exposure to airborne beryllium that would occur if the employee were
not using a respirator.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, United States Department of Labor, or
designee.
Beryllium lymphocyte proliferation test (BeLPT) means the
measurement of blood lymphocyte proliferation in a laboratory test when
lymphocytes are challenged with a soluble beryllium salt.
CBD diagnostic center means a medical diagnostic center that has an
on-site pulmonary specialist and on-site facilities to perform a
clinical evaluation for the presence of chronic beryllium disease
(CBD). This evaluation must include pulmonary function testing (as
outlined by the American Thoracic Society criteria), bronchoalveolar
lavage (BAL), and transbronchial biopsy. The CBD diagnostic center must
also have the capacity to transfer BAL samples to a laboratory for
appropriate diagnostic testing within 24 hours. The on-site pulmonary
specialist must be able to interpret the biopsy pathology and the BAL
diagnostic test results.
Chronic beryllium disease (CBD) means a chronic lung disease
associated with airborne exposure to beryllium.
Competent person means an individual who is capable of identifying
existing and foreseeable beryllium hazards in the workplace and who has
authorization to take prompt corrective measures to eliminate or
minimize them. The competent person must have the knowledge, ability,
and authority necessary to fulfill the responsibilities set forth in
paragraph (e) of this standard.
Confirmed positive means the person tested has beryllium
sensitization, as indicated by two abnormal BeLPT test results, an
abnormal and a borderline test result, or three borderline test
results. It also means the result of a more reliable and accurate test
indicating a person has been identified as having beryllium
sensitization.
Director means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee.
Emergency means any uncontrolled release of airborne beryllium.
High-efficiency particulate air (HEPA) filter means a filter that
is at least 99.97 percent efficient in removing particles 0.3
micrometers in diameter.
Objective data means information, such as air monitoring data from
industry-wide surveys or calculations based on the composition of a
substance, demonstrating airborne exposure to beryllium associated with
a particular product or material or a specific process, task, or
activity. The data must reflect workplace conditions closely resembling
or with a higher airborne exposure potential than the processes, types
of material, control methods, work practices, and environmental
conditions in the employer's current operations.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services required by paragraph (k) of this standard.
This standard means this beryllium standard, 29 CFR 1926.1124.
(c) Permissible Exposure Limits (PELs)--(1) Time-weighted average
(TWA) PEL. The employer must ensure that no employee is exposed to an
airborne concentration of beryllium in excess of 0.2 μg/m3\
calculated as an 8-hour TWA.
(2) Short-term exposure limit (STEL). The employer must ensure that
no employee is exposed to an airborne concentration of beryllium in
excess of 2.0 μg/m3\ as determined over a sampling period of 15
minutes.
(d) Exposure assessment--(1) General. The employer must assess the
airborne exposure of each employee who is or may reasonably be expected
to be exposed to airborne beryllium in accordance with either the
performance option in paragraph (d)(2) or the scheduled monitoring
option in paragraph (d)(3) of this standard.
(2) Performance option. The employer must assess the 8-hour TWA
exposure and the 15-minute short-term exposure for each employee on the
basis of any
combination of air monitoring data and objective data sufficient to
accurately characterize airborne exposure to beryllium.
(3) Scheduled monitoring option. (i) The employer must perform
initial monitoring to assess the 8-hour TWA exposure for each employee
on the basis of one or more personal breathing zone air samples that
reflect the airborne exposure of employees on each shift, for each job
classification, and in each work area.
(ii) The employer must perform initial monitoring to assess the
short-term exposure from 15-minute personal breathing zone air samples
measured in operations that are likely to produce airborne exposure
above the STEL for each work shift, for each job classification, and in
each work area.
(iii) Where several employees perform the same tasks on the same
shift and in the same work area, the employer may sample a
representative fraction of these employees in order to meet the
requirements of paragraph (d)(3). In representative sampling, the
employer must sample the employee(s) expected to have the highest
airborne exposure to beryllium.
(iv) If initial monitoring indicates that airborne exposure is
below the action level and at or below the STEL, the employer may
discontinue monitoring for those employees whose airborne exposure is
represented by such monitoring.
(v) Where the most recent exposure monitoring indicates that
airborne exposure is at or above the action level but at or below the
TWA PEL, the employer must repeat such monitoring within six months of
the most recent monitoring.
(vi) Where the most recent exposure monitoring indicates that
airborne exposure is above the TWA PEL, the employer must repeat such
monitoring within three months of the most recent 8-hour TWA exposure
monitoring.
(vii) Where the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the action level, the
employer must repeat such monitoring within six months of the most
recent monitoring until two consecutive measurements, taken 7 or more
days apart, are below the action level, at which time the employer may
discontinue 8-hour TWA exposure monitoring for those employees whose
exposure is represented by such monitoring, except as otherwise
provided in paragraph (d)(4) of this standard.
(viii) Where the most recent exposure monitoring indicates that
airborne exposure is above the STEL, the employer must repeat such
monitoring within three months of the most recent short-term exposure
monitoring until two consecutive measurements, taken 7 or more days
apart, are below the STEL, at which time the employer may discontinue
short-term exposure monitoring for those employees whose exposure is
represented by such monitoring, except as otherwise provided in
paragraph (d)(4) of this standard.
(4) Reassessment of exposure. The employer must reassess airborne
exposure whenever a change in the production, process, control
equipment, personnel, or work practices may reasonably be expected to
result in new or additional airborne exposure at or above the action
level or STEL, or when the employer has any reason to believe that new
or additional airborne exposure at or above the action level or STEL
has occurred.
(5) Methods of sample analysis. The employer must ensure that all
air monitoring samples used to satisfy the monitoring requirements of
paragraph (d) of this standard are evaluated by a laboratory that can
measure beryllium to an accuracy of plus or minus 25 percent within a
statistical confidence level of 95 percent for airborne concentrations
at or above the action level.
(6) Employee notification of assessment results. (i) Within 15
working days after completing an exposure assessment in accordance with
paragraph (d) of this standard, the employer must notify each employee
whose airborne exposure is represented by the assessment of the results
of that assessment individually in writing or post the results in an
appropriate location that is accessible to each of these employees.
(ii) Whenever an exposure assessment indicates that airborne
exposure is above the TWA PEL or STEL, the employer must describe in
the written notification the corrective action being taken to reduce
airborne exposure to or below the exposure limit(s) exceeded where
feasible corrective action exists but had not been implemented when the
monitoring was conducted.
(7) Observation of monitoring. (i) The employer must provide an
opportunity to observe any exposure monitoring required by this
standard to each employee whose airborne exposure is measured or
represented by the monitoring and each employee's representative(s).
(ii) When observation of monitoring requires entry into an area
where the use of personal protective clothing or equipment (which may
include respirators) is required, the employer must provide each
observer with appropriate personal protective clothing and equipment at
no cost to the observer.
(iii) The employer must ensure that each observer follows all other
applicable safety and health procedures.
(e) Competent person. Wherever employees are, or can reasonably be
expected to be, exposed to airborne beryllium at levels above the TWA
PEL or STEL, the employer must designate a competent person to
(1) Make frequent and regular inspections of job sites, materials,
and equipment;
(2) Implement the written exposure control plan under paragraph (f)
of this standard;
(3) Ensure that all employees use respiratory protection in
accordance with paragraph (g) of this standard; and
(4) Ensure that all employees use personal protective clothing and
equipment in accordance with paragraph (h) of this standard.
(f) Methods of compliance--(1) Written exposure control plan. (i)
The employer must establish, implement, and maintain a written exposure
control plan, which must contain:
(A) A list of operations and job titles reasonably expected to
involve airborne exposure to or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to
involve airborne exposure at or above the action level;
(C) A list of operations and job titles reasonably expected to
involve airborne exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination;
(E) Procedures for minimizing the migration of beryllium within or
to locations outside the workplace;
(F) A list of engineering controls, work practices, and respiratory
protection required by paragraph (f)(2) of this standard;
(G) A list of personal protective clothing and equipment required
by paragraph (h) of this standard;
(H) Procedures for removing, laundering, storing, cleaning,
repairing, and disposing of beryllium-contaminated personal protective
clothing and equipment, including respirators; and
(I) Procedures used to restrict access to work areas when airborne
exposures are, or can reasonably be expected to be, above the TWA PEL
or STEL, to minimize the number of employees exposed to airborne
beryllium and their level of exposure, including exposures generated by
other employers or sole proprietors.
(ii) The employer must review and evaluate the effectiveness of
each
written exposure control plan at least annually and update it, as
necessary, when:
(A) Any change in production processes, materials, equipment,
personnel, work practices, or control methods results, or can
reasonably be expected to result, in new or additional airborne
exposure to beryllium;
(B) The employer is notified that an employee is eligible for
medical removal in accordance with paragraph (l)(1) of this standard,
referred for evaluation at a CBD diagnostic center, or shows signs or
symptoms associated with airborne exposure to or dermal contact with
beryllium; or
(C) The employer has any reason to believe that new or additional
airborne exposure is occurring or will occur.
(iii) The employer must make a copy of the written exposure control
plan accessible to each employee who is, or can reasonably be expected
to be, exposed to airborne beryllium in accordance with OSHA's Access
to Employee Exposure and Medical Records (Records Access) standard (29
CFR 1910.1020(e)).
(2) Engineering and work practice controls. (i) Where exposures
are, or can reasonably be expected to be, at or above the action level,
the employer must ensure that at least one of the following is in place
to reduce airborne exposure:
(A) Material and/or process substitution;
(B) Isolation, such as ventilated partial or full enclosures;
(C) Local exhaust ventilation, such as at the points of operation,
material handling, and transfer; or
(D) Process control, such as wet methods and automation.
(ii) An employer is exempt from using the controls listed in
paragraph (f)(2)(i) of this standard to the extent that:
(A) The employer can establish that such controls are not feasible;
or
(B) The employer can demonstrate that airborne exposure is below
the action level, using no fewer than two representative personal
breathing zone samples taken at least 7 days apart, for each affected
operation.
(iii) If airborne exposure exceeds the TWA PEL or STEL after
implementing the control(s) required by paragraph (f)(2)(i) of this
standard, the employer must implement additional or enhanced
engineering and work practice controls to reduce airborne exposure to
or below the exposure limit(s) exceeded.
(iv) Wherever the employer demonstrates that it is not feasible to
reduce airborne exposure to or below the PELs by the engineering and
work practice controls required by paragraphs (f)(2)(i) and
(f)(2)(iii), the employer must implement and maintain engineering and
work practice controls to reduce airborne exposure to the lowest levels
feasible and supplement these controls by using respiratory protection
in accordance with paragraph (g) of this standard.
(3) Prohibition of rotation. The employer must not rotate employees
to different jobs to achieve compliance with the PELs.
(g) Respiratory protection--(1) General. The employer must provide
respiratory protection at no cost to the employee and ensure that each
employee uses respiratory protection:
(i) During periods necessary to install or implement feasible
engineering and work practice controls where airborne exposure exceeds,
or can reasonably be expected to exceed, the TWA PEL or STEL;
(ii) During operations, including maintenance and repair activities
and non-routine tasks, when engineering and work practice controls are
not feasible and airborne exposure exceeds, or can reasonably be
expected to exceed, the TWA PEL or STEL;
(iii) During operations for which an employer has implemented all
feasible engineering and work practice controls when such controls are
not sufficient to reduce airborne exposure to or below the TWA PEL or
STEL;
(iv) During emergencies; and
(v) When an employee who is eligible for medical removal under
paragraph (l)(1) chooses to remain in a job with airborne exposure at
or above the action level, as permitted by paragraph (l)(2)(ii) of this
standard.
(2) Respiratory protection program. Where this standard requires an
employer to provide respiratory protection, the selection and use of
such respiratory protection must be in accordance with the Respiratory
Protection standard (29 CFR 1910.134).
(3) The employer must provide at no cost to the employee a powered
air-purifying respirator (PAPR) instead of a negative pressure
respirator when
(i) Respiratory protection is required by this standard;
(ii) An employee entitled to such respiratory protection requests a
PAPR; and
(iii) The PAPR provides adequate protection to the employee in
accordance with paragraph (g)(2) of this standard.
(h) Personal protective clothing and equipment--(1) Provision and
use. The employer must provide at no cost, and ensure that each
employee uses, appropriate personal protective clothing and equipment
in accordance with the written exposure control plan required under
paragraph (f)(1) of this standard and OSHA's Personal Protective and
Life Saving Equipment standards for construction (29 CFR part 1926
Subpart E):
(i) Where airborne exposure exceeds, or can reasonably be expected
to exceed, the TWA PEL or STEL; or
(ii) Where there is a reasonable expectation of dermal contact with
beryllium.
(2) Removal and storage. (i) The employer must ensure that each
employee removes all beryllium-contaminated personal protective
clothing and equipment at the end of the work shift, at the completion
of tasks involving beryllium, or when personal protective clothing or
equipment becomes visibly contaminated with beryllium, whichever comes
first.
(ii) The employer must ensure that each employee removes beryllium-
contaminated personal protective clothing and equipment as specified in
the written exposure control plan required by paragraph (f)(1) of this
standard.
(iii) The employer must ensure that each employee stores and keeps
beryllium-contaminated personal protective clothing and equipment
separate from street clothing and that storage facilities prevent
cross-contamination as specified in the written exposure control plan
required by paragraph (f)(1) of this standard.
(iv) The employer must ensure that no employee removes beryllium-
contaminated personal protective clothing or equipment from the
workplace, except for employees authorized to do so for the purposes of
laundering, cleaning, maintaining or disposing of beryllium-
contaminated personal protective clothing and equipment at an
appropriate location or facility away from the workplace.
(v) When personal protective clothing or equipment required by this
standard is removed from the workplace for laundering, cleaning,
maintenance or disposal, the employer must ensure that personal
protective clothing and equipment are stored and transported in sealed
bags or other closed containers that are impermeable and are labeled in
accordance with paragraph (m)(2) of this standard and the HCS (29 CFR
1910.1200).
(3) Cleaning and replacement. (i) The employer must ensure that all
reusable personal protective clothing and equipment required by this
standard is cleaned, laundered, repaired, and replaced as needed to
maintain its effectiveness.
(ii) The employer must ensure that beryllium is not removed from
personal protective clothing and equipment by blowing, shaking or any
other means that disperses beryllium into the air.
(iii) The employer must inform in writing the persons or the
business entities who launder, clean or repair the personal protective
clothing or equipment required by this standard of the potentially
harmful effects of airborne exposure to and dermal contact with
beryllium and that the personal protective clothing and equipment must
be handled in accordance with this standard.
(i) Hygiene areas and practices--(1) General. For each employee
required to use personal protective clothing or equipment by this
standard, the employer must:
(i) Provide readily accessible washing facilities in accordance
with this standard and the Sanitation standard (Sec. 1926.51) to
remove beryllium from the hands, face, and neck; and
(ii) Ensure that employees who have dermal contact with beryllium
wash any exposed skin at the end of the activity, process, or work
shift and prior to eating, drinking, smoking, chewing tobacco or gum,
applying cosmetics, or using the toilet.
(2) Change rooms. In addition to the requirements of paragraph
(i)(1)(i) of this standard, the employer must provide employees
required to use personal protective clothing by this standard with a
designated change room in accordance with this standard and the
Sanitation standard (Sec. 1926.51) where employees are required to
remove their personal clothing.
(3) Eating and drinking areas. Wherever the employer allows
employees to consume food or beverages at a worksite where beryllium is
present, the employer must ensure that:
(i) Surfaces in eating and drinking areas are as free as
practicable of beryllium;
(ii) No employees enter any eating or drinking area with personal
protective clothing or equipment unless, prior to entry, surface
beryllium has been removed from the clothing or equipment by methods
that do not disperse beryllium into the air or onto an employee's body;
and
(iii) Eating and drinking facilities provided by the employer are
in accordance with the Sanitation standard (Sec. 1926.51).
(4) Prohibited activities. The employer must ensure that no
employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in
work areas where there is a reasonable expectation of exposure above
the TWA PEL or STEL.
(j) Housekeeping--(1) General. (i) When cleaning beryllium-
contaminated areas, the employer must follow the written exposure
control plan required under paragraph (f)(1) of this standard;
(ii) The employer must ensure that all spills and emergency
releases of beryllium are cleaned up promptly and in accordance with
the written exposure control plan required under paragraph (f)(1) of
this standard.
(2) Cleaning methods. (i) When cleaning beryllium-contaminated
areas, the employer must ensure the use of HEPA-filtered vacuuming or
other methods that minimize the likelihood and level of airborne
exposure.
(ii) The employer must not allow dry sweeping or brushing for
cleaning in beryllium-contaminated areas unless HEPA-filtered vacuuming
or other methods that minimize the likelihood and level of airborne
exposure are not safe or effective.
(iii) The employer must not allow the use of compressed air for
cleaning in beryllium-contaminated areas unless the compressed air is
used in conjunction with a ventilation system designed to capture the
particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air
to clean in beryllium-contaminated areas, the employer must provide,
and ensure that each employee uses, respiratory protection and personal
protective clothing and equipment in accordance with paragraphs (g) and
(h) of this standard.
(v) The employer must ensure that cleaning equipment is handled and
maintained in a manner that minimizes the likelihood and level of
airborne exposure and the re-entrainment of airborne beryllium in the
workplace.
(3) Disposal. When the employer transfers materials containing
beryllium to another party for use or disposal, the employer must
provide the recipient with a copy of the warning described in paragraph
(m)(2) of this standard.
(k) Medical surveillance--(1) General. (i) The employer must make
medical surveillance required by this paragraph available at no cost to
the employee, and at a reasonable time and place, to each employee:
(A) Who is or is reasonably expected to be exposed at or above the
action level for more than 30 days per year;
(B) Who shows signs or symptoms of CBD or other beryllium-related
health effects;
(C) Who is exposed to beryllium during an emergency; or
(D) Whose most recent written medical opinion required by paragraph
(k)(6) or (k)(7) recommends periodic medical surveillance.
(ii) The employer must ensure that all medical examinations and
procedures required by this standard are performed by, or under the
direction of, a licensed physician.
(2) Frequency. The employer must provide a medical examination:
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A),
unless the employee has received a medical examination, provided in
accordance with this standard, within the last two years; or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or
(C).
(ii) At least every two years thereafter for each employee who
continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D)
of this standard.
(iii) At the termination of employment for each employee who meets
any of the criteria of paragraph (k)(1)(i) of this standard at the time
the employee's employment terminates, unless an examination has been
provided in accordance with this standard during the six months prior
to the date of termination.
(3) Contents of examination. (i) The employer must ensure that the
PLHCP conducting the examination advises the employee of the risks and
benefits of participating in the medical surveillance program and the
employee's right to opt out of any or all parts of the medical
examination.
(ii) The employer must ensure that the employee is offered a
medical examination that includes:
(A) A medical and work history, with emphasis on past and present
airborne exposure to or dermal contact with beryllium, smoking history,
and any history of respiratory system dysfunction;
(B) A physical examination with emphasis on the respiratory system;
(C) A physical examination for skin rashes;
(D) Pulmonary function tests, performed in accordance with the
guidelines established by the American Thoracic Society including
forced vital capacity (FVC) and forced expiratory volume in one second
(FEV1);
(E) A standardized BeLPT or equivalent test, upon the first
examination and at least every two years thereafter, unless the
employee is confirmed positive. If the results of the BeLPT are other
than normal, a follow-up BeLPT must be offered within 30 days, unless
the employee has been
confirmed positive. Samples must be analyzed in a laboratory certified
under the College of American Pathologists/Clinical Laboratory
Improvement Amendments (CLIA) guidelines to perform the BeLPT.
(F) A low dose computed tomography (LDCT) scan, when recommended by
the PLHCP after considering the employee's history of exposure to
beryllium along with other risk factors, such as smoking history,
family medical history, sex, age, and presence of existing lung
disease; and
(G) Any other test deemed appropriate by the PLHCP.
(4) Information provided to the PLHCP. The employer must ensure
that the examining PLHCP (and the agreed-upon CBD diagnostic center, if
an evaluation is required under paragraph (k)(7) of this standard) has
a copy of this standard and must provide the following information, if
known:
(i) A description of the employee's former and current duties that
relate to the employee's airborne exposure to and dermal contact with
beryllium;
(ii) The employee's former and current levels of airborne exposure;
(iii) A description of any personal protective clothing and
equipment, including respirators, used by the employee, including when
and for how long the employee has used that personal protective
clothing and equipment; and
(iv) Information from records of employment-related medical
examinations previously provided to the employee, currently within the
control of the employer, after obtaining written consent from the
employee.
(5) Licensed physician's written medical report for the employee.
The employer must ensure that the employee receives a written medical
report from the licensed physician within 45 days of the examination
(including any follow-up BeLPT required under paragraph (k)(3)(ii)(E)
of this standard) and that the PLHCP explains the results of the
examination to the employee. The written medical report must contain:
(i) A statement indicating the results of the medical examination,
including the licensed physician's opinion as to whether the employee
has
(A) Any detected medical condition, such as CBD or beryllium
sensitization (i.e., the employee is confirmed positive, as defined in
paragraph (b) of this standard), that may place the employee at
increased risk from further airborne exposure, and
(B) Any medical conditions related to airborne exposure that
require further evaluation or treatment.
(ii) Any recommendations on:
(A) The employee's use of respirators, protective clothing, or
equipment; or
(B) Limitations on the employee's airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD
or if the licensed physician otherwise deems it appropriate, the
written report must also contain a referral for an evaluation at a CBD
diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD
the written report must also contain a recommendation for continued
periodic medical surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD the
written report must also contain a recommendation for medical removal
from airborne exposure to beryllium, as described in paragraph (l).
(6) Licensed physician's written medical opinion for the employer.
(i) The employer must obtain a written medical opinion from the
licensed physician within 45 days of the medical examination (including
any follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this
standard). The written medical opinion must contain only the following:
(A) The date of the examination;
(B) A statement that the examination has met the requirements of
this standard;
(C) Any recommended limitations on the employee's use of
respirators, protective clothing, or equipment; and
(D) A statement that the PLHCP has explained the results of the
medical examination to the employee, including any tests conducted, any
medical conditions related to airborne exposure that require further
evaluation or treatment, and any special provisions for use of personal
protective clothing or equipment;
(ii) If the employee provides written authorization, the written
opinion must also contain any recommended limitations on the employee's
airborne exposure to beryllium.
(iii) If the employee is confirmed positive or diagnosed with CBD
or if the licensed physician otherwise deems it appropriate, and the
employee provides written authorization, the written opinion must also
contain a referral for an evaluation at a CBD diagnostic center.
(iv) If the employee is confirmed positive or diagnosed with CBD
and the employee provides written authorization, the written opinion
must also contain a recommendation for continued periodic medical
surveillance.
(v) If the employee is confirmed positive or diagnosed with CBD and
the employee provides written authorization, the written opinion must
also contain a recommendation for medical removal from airborne
exposure to beryllium, as described in paragraph (l).
(vi) The employer must ensure that each employee receives a copy of
the written medical opinion described in paragraph (k)(6) of this
standard within 45 days of any medical examination (including any
follow-up BeLPT required under paragraph (k)(3)(ii)(E) of this
standard) performed for that employee.
(7) CBD diagnostic center. (i) The employer must provide an
evaluation at no cost to the employee at a CBD diagnostic center that
is mutually agreed upon by the employer and the employee. The
examination must be provided within 30 days of:
(A) The employer's receipt of a physician's written medical opinion
to the employer that recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician's written
medical report indicating that the employee has been confirmed positive
or diagnosed with CBD, or recommending referral to a CBD diagnostic
center.
(ii) The employer must ensure that the employee receives a written
medical report from the CBD diagnostic center that contains all the
information required in paragraphs (k)(5)(i), (ii), (iv), and (v) of
this standard and that the PLHCP explains the results of the
examination to the employee within 30 days of the examination.
(iii) The employer must obtain a written medical opinion from the
CBD diagnostic center within 30 days of the medical examination. The
written medical opinion must contain only the information in paragraph
(k)(6)(i) of this standard, as applicable, unless the employee provides
written authorization to release additional information. If the
employee provides written authorization, the written opinion must also
contain the information from paragraphs (k)(6)(ii), (iv), and (v), if
applicable.
(iv) The employer must ensure that each employee receives a copy of
the written medical opinion from the CBD diagnostic center described in
paragraph (k)(7) of this standard within 30 days of any medical
examination performed for that employee.
(v) After an employee has received the initial clinical evaluation
at a CBD diagnostic center described in paragraph (k)(7)(i) of this
standard, the employee may choose to have any subsequent
medical examinations for which the employee is eligible under paragraph
(k) of this standard performed at a CBD diagnostic center mutually
agreed upon by the employer and the employee, and the employer must
provide such examinations at no cost to the employee.
(l) Medical removal. (1) An employee is eligible for medical
removal, if the employee works in a job with airborne exposure at or
above the action level and either:
(i) The employee provides the employer with:
(A) A written medical report indicating a confirmed positive
finding or CBD diagnosis; or
(B) A written medical report recommending removal from airborne
exposure to beryllium in accordance with paragraph (k)(5)(v) or
(k)(7)(ii) of this standard; or
(ii) The employer receives a written medical opinion recommending
removal from airborne exposure to beryllium in accordance with
paragraph (k)(6)(v) or (k)(7)(iii) of this standard.
(2) If an employee is eligible for medical removal, the employer
must provide the employee with the employee's choice of:
(i) Removal as described in paragraph (l)(3) of this standard; or
(ii) Remaining in a job with airborne exposure at or above the
action level, provided that the employer provides, and ensures that the
employee uses, respiratory protection that complies with paragraph (g)
of this standard whenever airborne exposures are at or above the action
level.
(3) If the employee chooses removal:
(i) If a comparable job is available where airborne exposures to
beryllium are below the action level, and the employee is qualified for
that job or can be trained within one month, the employer must remove
the employee to that job. The employer must maintain for six months
from the time of removal the employee's base earnings, seniority, and
other rights and benefits that existed at the time of removal.
(ii) If comparable work is not available, the employer must
maintain the employee's base earnings, seniority, and other rights and
benefits that existed at the time of removal for six months or until
such time that comparable work described in paragraph (l)(3)(i) becomes
available, whichever comes first.
(4) The employer's obligation to provide medical removal protection
benefits to a removed employee shall be reduced to the extent that the
employee receives compensation for earnings lost during the period of
removal from a publicly or employer-funded compensation program, or
receives income from another employer made possible by virtue of the
employee's removal.
(m) Communication of hazards--(1) General. (i) Chemical
manufacturers, importers, distributors, and employers must comply with
all requirements of the HCS (29 CFR 1910.1200) for beryllium.
(ii) Employers must include beryllium in the hazard communication
program established to comply with the HCS. Employers must ensure that
each employee has access to labels on containers of beryllium and to
safety data sheets, and is trained in accordance with the requirements
of the HCS (29 CFR 1910.1200) and paragraph (m)(4) of this standard.
(2) Warning labels. Consistent with the HCS (29 CFR 1910.1200), the
employer must label each bag and container of clothing, equipment, and
materials contaminated with beryllium, and must, at a minimum, include
the following on the label:
DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN
(3) Employee information and training. (i) For each employee who
has, or can reasonably be expected to have, airborne exposure to or
dermal contact with beryllium:
(A) The employer must provide information and training in
accordance with the HCS (29 CFR 1910.1200(h));
(B) The employer must provide initial training to each employee by
the time of initial assignment; and
(C) The employer must repeat the training required under this
standard annually for each employee.
(ii) The employer must ensure that each employee who is, or can
reasonably be expected to be, exposed to airborne beryllium can
demonstrate knowledge and understanding of the following:
(A) The health hazards associated with airborne exposure to and
dermal contact with beryllium, including the signs and symptoms of CBD;
(B) The written exposure control plan, with emphasis on the
specific nature of operations that could result in airborne exposure,
especially airborne exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and
limitations of personal protective clothing and equipment, including
respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from airborne
exposure to and dermal contact with beryllium, including personal
hygiene practices;
(F) The purpose and a description of the medical surveillance
program required by paragraph (k) of this standard including risks and
benefits of each test to be offered;
(G) The purpose and a description of the medical removal protection
provided under paragraph (l) of this standard;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records
Access standard (29 CFR 1910.1020).
(iii) When a workplace change (such as modification of equipment,
tasks, or procedures) results in new or increased airborne exposure
that exceeds, or can reasonably be expected to exceed, either the TWA
PEL or the STEL, the employer must provide additional training to those
employees affected by the change in airborne exposure.
(iv) Employee information. The employer must make a copy of this
standard and its appendices readily available at no cost to each
employee and designated employee representative(s).
(n) Recordkeeping--(1) Air monitoring data. (i) The employer must
make and maintain a record of all exposure measurements taken to assess
airborne exposure as prescribed in paragraph (d) of this standard.
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task that is being monitored;
(C) The sampling and analytical methods used and evidence of their
accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment,
including respirators, worn by monitored employees at the time of
monitoring; and
(F) The name, social security number, and job classification of
each employee represented by the monitoring, indicating which employees
were actually monitored.
(iii) The employer must ensure that exposure records are maintained
and made available in accordance with the Records Access standard (29
CFR 1910.1020).
(2) Objective data. (i) Where an employer uses objective data to
satisfy the exposure assessment requirements under paragraph (d)(2) of
this standard, the employer must make and maintain
a record of the objective data relied upon.
(ii) This record must include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(D) A description of the process, task, or activity on which the
objective data were based; and
(E) Other data relevant to the process, task, activity, material,
or airborne exposure on which the objective data were based.
(iii) The employer must ensure that objective data are maintained
and made available in accordance with the Records Access standard (29
CFR 1910.1020).
(3) Medical surveillance. (i) The employer must make and maintain a
record for each employee covered by medical surveillance under
paragraph (k) of this standard.
(ii) The record must include the following information about each
employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written medical opinions for
each employee; and
(C) A copy of the information provided to the PLHCP as required by
paragraph (k)(4) of this standard.
(iii) The employer must ensure that medical records are maintained
and made available in accordance with the Records Access standard (29
CFR 1910.1020).
(4) Training. (i) At the completion of any training required by
this standard, the employer must prepare a record that indicates the
name, social security number, and job classification of each employee
trained, the date the training was completed, and the topic of the
training.
(ii) This record must be maintained for three years after the
completion of training.
(5) Access to records. Upon request, the employer must make all
records maintained as a requirement of this standard available for
examination and copying to the Assistant Secretary, the Director, each
employee, and each employee's designated representative(s) in
accordance the Records Access standard (29 CFR 1910.1020).
(6) Transfer of records. The employer must comply with the
requirements involving transfer of records set forth in the Records
Access standard (29 CFR 1910.1020).
(o) Dates--(1) Effective date. This standard shall become effective
March 10, 2017.
(2) Compliance dates. All obligations of this standard commence and
become enforceable on March 12, 2018, except:
(i) Change rooms required by paragraph (i) of this standard must be
provided by March 11, 2019; and
(ii) Engineering controls required by paragraph (f) of this
standard must be implemented by March 10, 2020.
[FR Doc. 2016-30409 Filed 1-6-17; 8:45 am]
BILLING CODE 4510-26-P
