[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Rules and Regulations]
[Pages 42582-42628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10678]
Vol. 85
Tuesday,
No. 135
July 14, 2020
Part III
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Part 1910
Revising the Beryllium Standard for General Industry; Final Rule
Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Rules
and Regulations
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2018-0003]
RIN 1218-AD20
Revising the Beryllium Standard for General Industry
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Final rule.
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SUMMARY: OSHA is amending its existing general industry standard for
occupational exposure to beryllium and beryllium compounds to clarify
certain provisions and simplify or improve compliance. The revisions in
this final rule are designed to maintain or enhance worker protections
overall by ensuring that the rule is well understood and compliance is
more straightforward.
DATES: This final rule becomes effective on September 14, 2020.
ADDRESSES: In accordance with 28 U.S.C. 2112(a)(2), OSHA designates
Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety
and Health, to receive petitions for review of the final rule. Contact
the Associate Solicitor at the Office of the Solicitor, Room S-4004,
U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC
20210; telephone: (202) 693-5445.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Mr. Frank Meilinger, OSHA Office of
Communications, Occupational Safety and Health Administration;
telephone: (202) 693-1999; email: meilinger.francis2@dol.gov.
General information and technical inquiries: Ms. Maureen Ruskin,
Directorate of Standards and Guidance, Occupational Safety and Health
Administration; telephone: (202) 693-1950; email:
ruskin.maureen@dol.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Events Leading to the Final Rule
III. Legal Considerations
IV. Final Economic Analysis and Regulatory Flexibility Act
Certification (FEA)
V. Office of Management and Budget (OMB) Review Under the Paperwork
Reduction Act of 1995
VI. Federalism
VII. State Plans
VIII. Unfunded Mandates Reform Act
IX. Consultation and Coordination With Indian Tribal Governments
X. Environmental Impacts
XI. Summary and Explanation of the Final Rule
List of Subjects for 29 CFR Part 1910
Authority
Citation Method
In the docket for this rulemaking found at http://www.regulations.gov, every submission was assigned a document
identification (ID) number that consists of the docket number (OSHA-
2018-0003) followed by an additional four-digit number. For example,
the document ID number for the proposed rule is OSHA-2018-0003-0016.
Some document ID numbers include one or more attachments (see, e.g.,
Document ID OSHA-2018-0003-0026).
When citing exhibits in the OSHA-2018-0003 docket in this preamble,
OSHA includes the term ``Document ID'' followed by the last four digits
of the document number; the attachment number or other attachment
identifier, if necessary for clarity; and page numbers (designated
``p.'' or ``pp.''). In a citation that contains two or more document ID
numbers, the document ID numbers are separated by semi-colons. For
example, a citation referring to National Jewish Health's comments and
the first attachment to Materion Brush, Inc.'s comments would be
indicated as follows: (Document ID 0022, pp. X-X; 0038-A1, p. X).
Occasionally this preamble refers to documents located in the
rulemaking dockets that were used for previous beryllium rulemaking
activities, including the 2017 final rule. When citing exhibits in
other dockets, OSHA includes the term ``Document ID'' followed by the
full document number. For example, this preamble cites a publication by
Armstrong et al. (2014), titled ``Migration of beryllium via multiple
exposure pathways among work processes in four different facilities,''
designated Document ID OSHA-H005C-2006-0870-0502.
The exhibits in the docket (and the other beryllium-rulemaking
dockets cited in this preamble), including public comments, supporting
materials, meeting transcripts, and other documents, are listed on
http://www.regulations.gov. All exhibits are listed in the docket index
on http://www.regulations.gov, but some exhibits (e.g., copyrighted
material) are not available to read or download from that website. All
materials in the docket are available for inspection at the OSHA Docket
Office, Room N-3508, U.S. Department of Labor, 200 Constitution Avenue
NW, Washington, DC 20210; telephone (202) 693-2350.
I. Executive Summary
On January 9, 2017, OSHA published a final rule on Occupational
Exposure to Beryllium and Beryllium Compounds (82 FR 2470). This rule
created health standards for beryllium exposure in the general industry
(29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyards (29
CFR 1915.1024) sectors. On December 11, 2018, OSHA published a Notice
of Proposed Rulemaking (NPRM) in which the agency proposed various
amendments to the beryllium standard for general industry (83 FR
63746). With the proposed revisions, OSHA sought to clarify certain
provisions and simplify or improve compliance with the beryllium
standard for general industry. In this final rule, OSHA is finalizing
the majority of the changes proposed in the NPRM, with some revisions
intended to address concerns raised by stakeholders during the comment
period. OSHA believes that these changes to the standard will maintain
safety and health protections for workers and will further enhance
worker protections by ensuring that the standard is well-understood.
The changes to the final standard for general industry are fully
discussed in Section XI, Summary and Explanation of the Final Rule.
Broadly, OSHA proposed to add one definition and modify five existing
terms in paragraph (b), Definitions; to amend paragraph (f), Methods of
compliance; paragraph (h), Personal protective clothing and equipment;
paragraph (i), Hygiene areas and practices; paragraph (j),
Housekeeping; paragraph (k), Medical surveillance; paragraph (m),
Communication of hazards; and paragraph (n), Recordkeeping; and to
replace the 2017 final standard's Appendix A with a new appendix
designed to supplement the proposed definition of beryllium work area.
OSHA is finalizing these provisions as proposed, with the following
exceptions. First, OSHA is revising the definition of confirmed
positive to state that the findings of two abnormal, one abnormal and
one borderline, or three borderline results need to occur from
beryllium lymphocyte proliferation tests (BeLPTs) conducted within a
three-year period. This differs from the definition proposed in the
2018 NPRM, which would have required that any combination of test
results specified in the definition must be obtained within the 30-day
follow-up test period required after a first abnormal or borderline
BeLPT test result. Second, OSHA is modifying the proposed paragraph
(j)(3), which requires employers to take certain actions when
transferring materials that contain at least 0.1 percent beryllium by
weight or that are contaminated with beryllium outside a plant for the
purpose of disposal, recycling, or reuse, to clarify that only
transfers outside of a plant, including between facilities owned by the
same employer, are subject to the labeling requirements of paragraph
(m)(3).
Third, in paragraphs (k)(2)(iii) and (iv), OSHA is modifying the
proposed provisions pertaining to an employer's obligation to offer a
medical examination after an employee is exposed to beryllium in an
emergency. Fourth, OSHA is amending proposed paragraph (k)(7)(i) to
require that an examination at a chronic beryllium disease (CBD)
diagnostic center be scheduled within 30 days of the employer receiving
certain types of documentation, listed in paragraph (k)(7)(i)(A) and
(B), that trigger evaluation for CBD. OSHA is further revising proposed
paragraph (k)(7) by adding a new provision, paragraph (k)(7)(ii), which
clarifies that, as part of the evaluation at the CBD diagnostic center,
the employer must ensure that the employee is offered any tests deemed
appropriate by the examining physician at the CBD diagnostic center and
to state that if any tests deemed appropriate by the physician are not
available at the CBD diagnostic center, they may be performed at
another location that is mutually agreed upon by the employer and the
employee. For a full explanation of comments received and OSHA's
reasoning for these revisions, see Section XI, Summary and Explanation
of the Final Rule.
OSHA's examination of the technological and economic feasibility of
this final rule is presented in the Final Economic Analysis and
Regulatory Flexibility Analysis (FEA), in Section IV of this preamble.
As explained there, OSHA finds that none of the revisions would impose
any new employer obligations or increase the overall cost of
compliance, while some of the revisions in this final rule will clarify
and simplify compliance in such a way that results in cost savings.
OSHA also finds that none of the revisions would require any new
controls or other technology. OSHA therefore concludes that the final
rule is both economically and technologically feasible.
Further, this final rule is considered to be an Executive Order
(E.O.) 13771 deregulatory action. Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory
Affairs designated this rule not a ``major rule,'' as defined by 5
U.S.C. 804(2).
II. Events Leading to the Final Rule
On January 9, 2017, OSHA published the final rule Occupational
Exposure to Beryllium and Beryllium Compounds (2017 final rule) in the
Federal Register (82 FR 2470).\1\ Therein, OSHA concluded that
employees exposed to beryllium and beryllium compounds at the preceding
permissible exposure limits (PELs) were at significant risk of material
impairment of health, specifically chronic beryllium disease (CBD) and
lung cancer. The agency further determined that limiting employee
exposure to an 8-hour time-weighted average (TWA) PEL of 0.2 [micro]g/
m\3\ would reduce this significant risk to the maximum extent feasible.
Therefore, the 2017 final rule adopted a TWA PEL of 0.2 [micro]g/m\3\.
In addition to the revised PEL, the 2017 final rule established a new
short-term exposure limit (STEL) of 2.0 [micro]g/m\3\ over a 15-minute
sampling period and an action level of 0.1 [micro]g/m\3\ as an 8-hour
TWA, along with a number of ancillary provisions intended to provide
additional protections to employees. The ancillary provisions included
requirements for exposure assessment, methods for controlling exposure,
respiratory protection, personal protective clothing and equipment,
housekeeping, medical surveillance, hazard communication, and
recordkeeping that are similar to those found in other OSHA health
standards.
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\1\ In the 2017 final rule, OSHA issued three separate beryllium
standards--general industry, shipyards, and construction. This final
rule amends only the general industry standard. Therefore, neither
this Events Leading to the Final Rule section nor the remainder of
the preamble will include information about the other two standards.
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The 2017 final rule went into effect on May 20, 2017, and OSHA
began enforcing the PEL and the general industry standard's provisions
for exposure assessment, respiratory protection, medical surveillance,
and medical removal on May 11, 2018. See Updated Interim Enforcement
Guidance for the Beryllium Standards, available at https://www.osha.gov/laws-regs/standardinterpretations/2018-12-11. The majority
of the general industry standard's other provisions became enforceable
on December 12, 2018, with compliance obligations for showers and
change rooms following on March 11, 2019 (83 FR 39351). OSHA began
enforcing the general industry requirements for engineering controls on
March 10, 2020.
In response to concerns raised by stakeholders following the
publication of the 2017 final rule, OSHA published a direct final rule
(DFR) in the Federal Register on May 7, 2018 (83 FR 19936), amending
the text of the beryllium standard for general industry to clarify
OSHA's intent with respect to certain terms in the standard, including
the definition of beryllium work area (BWA), the definition of
emergency, and the meaning of the terms dermal contact and beryllium
contamination (see 83 FR at 19938). The DFR also clarified OSHA's
intent with respect to provisions for disposal and recycling and with
respect to provisions that the agency intended to apply only where skin
can be exposed to materials containing at least 0.1% beryllium by
weight (83 FR at 19938). Because the agency did not receive any
significant adverse comments, OSHA published a Federal Register notice
confirming the effective date of the DFR as July 6, 2018, and
withdrawing the companion NPRM (83 FR 31045 (July 3, 2018)).
On December 11, 2018, OSHA published an NPRM in the Federal
Register (83 FR 63746) in which the agency proposed to further amend
the beryllium standard for general industry.\2\ The proposal sought to
clarify certain provisions-with proposed changes designed to facilitate
application of the standard consistent with the intent of the 2017
final rule-and to simplify or improve compliance, preventing costs that
may flow from misinterpretation or misapplication of the standard. OSHA
requested public comment on the proposed changes and provided
stakeholders 60 days to submit comments. OSHA received 22 comments
before the comment period closed on February 11, 2019.
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\2\ OSHA stated in the NPRM that the agency believed that the
standard as modified by the proposal would provide equivalent
protection to the existing standard; and OSHA would therefore accept
compliance with the standard, as modified by the proposal, as
compliance with the standard while the rulemaking was pending.
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III. Legal Considerations
The purpose of the Occupational Safety and Health Act of 1970
(``the OSH Act'' or ``the Act''), 29 U.S.C. 651 et seq., 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 promulgate occupational safety and
health standards pursuant to notice and comment rulemaking. See 29
U.S.C. 655(b). An occupational safety or health standard is a standard
which requires conditions, or the adoption or use of one or more
practices, means, methods, operations, or processes, reasonably
necessary or appropriate to provide safe
or healthful employment and places of employment. 29 U.S.C. 652(8).
The Act also authorizes the Secretary to ``modify'' or ``revoke''
any occupational safety or health standard, 29 U.S.C. 655(b), and under
the Administrative Procedure Act, regulatory agencies generally may
revise their rules if the changes are supported by a reasoned analysis,
see Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463
U.S. 29, 42 (1983). ``While the removal of a regulation may not entail
the monetary expenditures and other costs of enacting a new standard,
and accordingly, it may be easier for an agency to justify a
deregulatory action, the direction in which an agency chooses to move
does not alter the standard of judicial review established by law.''
Id.
The Act provides that in promulgating health standards dealing with
toxic materials or harmful physical agents, such as the January 9,
2017, final rule regulating occupational exposure to beryllium, the
Secretary must set the standard that most adequately assures, to the
extent feasible and 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).
The Supreme Court has held that before the Secretary can promulgate
any permanent health or safety standard, he must make a threshold
finding that significant risk is present and that such risk can be
eliminated or lessened by a change in practices. See Indus. Union
Dep't, AFL-CIO v. Am. Petroleum Inst. (``Benzene''), 448 U.S. 607, 641-
42 (1980) (plurality opinion). OSHA need not make additional findings
on risk for this revised rule because OSHA previously determined that
the beryllium standard addresses a significant risk that can be
eliminated or lessened by a change in practices, see 82 FR 2545-52, and
the changes and clarifications in this final rule do not affect that
determination. See, e.g., Pub. Citizen Health Research Grp. v. Tyson,
796 F.2d 1479, 1502 n.16 (D.C. Cir. 1986) (rejecting the argument that
OSHA must ``find that each and every aspect of its standard eliminates
a significant risk'').
OSHA standards must also be both technologically and economically
feasible. See United Steelworkers of Am., AFL-CIO-CLC v. Marshall
(``Lead I''), 647 F.2d 1189, 1264 (D.C. Cir. 1980). The Supreme Court
has defined feasibility as ``capable of being done.'' Am. Textile Mfrs.
Inst. v. Donovan (``Cotton Dust''), 452 U.S. 490, 508-09 (1981). The
courts have further clarified that a standard is technologically
feasible if OSHA proves a reasonable possibility, ``within the limits
of the best available evidence . . . that the typical firm will be able
to develop and install engineering and work practice controls that can
meet the [standard] in most of its operations.'' Lead I, 647 F.2d at
1272. With respect to economic feasibility, the courts have held that
``[a] standard is feasible if it does not threaten massive dislocation
to or imperil the existence of the industry.'' Id. at 1265 (internal
quotation marks and citations omitted).
OSHA exercises significant discretion in carrying out its
responsibilities under the Act. Indeed, ``[a] number of terms of the
statute give OSHA almost unlimited discretion to devise means to
achieve the congressionally mandated goal'' of ensuring worker safety
and health. See Lead I, 647 F.2d at 1230 (citation omitted). Thus,
where OSHA has chosen some measures to address a significant risk over
other measures, parties challenging the OSHA standard must ``identify
evidence that their proposals would be feasible and generate more than
a de minimis benefit to worker health.'' N. Am.'s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 282 (D.C. Cir. 2017).
Although OSHA is required to set standards ``on the basis of the
best available evidence,'' 29 U.S.C. 655(b)(5), its determinations are
``conclusive'' if supported by ``substantial evidence in the record
considered as a whole,'' 29 U.S.C. 655(f). Similarly, as the Supreme
Court noted in Benzene, OSHA must look to ``a body of reputable
scientific thought'' in making determinations, but 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. When
there is disputed scientific evidence in the record, OSHA must review
the evidence on both sides and ``reasonably resolve'' the dispute.
Tyson, 796 F.2d at 1500. The ``possibility of drawing two inconsistent
conclusions from the evidence does not prevent the agency's finding
from being supported by substantial evidence.'' N. Am.'s Bldg. Trades
Unions, 878 F.3d at 291 (quoting Cotton Dust, 452 U.S. at 523)
(alterations omitted). As the D.C. Circuit has noted, 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. Tyson, 796 F.2d at 1500.
Finally, because section 6(b)(5) of the Act explicitly requires
OSHA to set health standards that eliminate risk ``to the extent
feasible,'' OSHA uses feasibility analysis rather than cost-benefit
analysis to make standards-setting decisions dealing with toxic
materials or harmful physical agents. 29 U.S.C. 655(b)(5). An OSHA
standard in this area must be technologically and economically
feasible-and also cost effective, which means that the protective
measures it requires are the least costly of the available alternatives
that achieve the same level of protection-but OSHA cannot choose an
alternative that provides a lower level of protection for workers'
health simply because it is less costly. See Int'l Union, UAW v. OSHA,
37 F.3d 665, 668 (D.C. Cir. 1994); see also Cotton Dust, 452 U.S. at
513 n.32. In Cotton Dust, the Court explained that Congress itself had
defined the appropriate relationship between costs and benefits by
prioritizing the ``benefit'' of worker health above all other
considerations, save those that would make this ``benefit''
unachievable. The Court further stated that 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 section 6(b)(5). See Cotton Dust, 452
U.S. at 509. Thus, while OSHA estimates the costs and benefits of its
proposed and final rules, in part to ensure compliance with
requirements such as those in Executive Orders 12866 and 13771, these
calculations do not form the basis for the agency's regulatory
decisions.
IV. Final Economic Analysis and Regulatory Flexibility Act
Certification (FEA)
A. Summary of Economic Impact
This rule amends OSHA's existing general industry standard for
occupational exposure to beryllium and beryllium compounds (29 CFR
1910.1024) to clarify certain provisions and simplify or improve
compliance. OSHA's final economic analysis shows that these changes
will result in unquantifiable cost savings, largely due to the
prevention of misinterpretation and misapplication of the standard.
In promulgating the 2017 final rule, OSHA determined that the
beryllium rule was both technologically and economically feasible. See
82 FR at 2582-86, 2590-96, Summary of the Final Economic Analysis. The
changes herein are intended to align the rule more clearly with the
intent of the 2017 final rule. Because OSHA has
determined that this final rule will decrease the costs of compliance
by preventing misinterpretation and misapplication of the standard, and
would require no new controls or other technology, OSHA has also
determined that the rule is both technologically and economically
feasible.
Because this final rule only clarifies the existing beryllium
standard or makes minor revisions that will generally aid in
compliance, the revised beryllium standard will maintain safety and
health protections for workers. And, to the extent this final rule
helps employers avoid misapplication of the beryllium standard's
requirements and hence achieves greater compliance with the standard's
intended meaning, there will be increased protection for workers.
B. Final Economic Analysis and Regulatory Flexibility Act Certification
Executive Orders 12866 and 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act (UMRA) (2 U.S.C.
1532(a)) require that OSHA estimate the benefits, costs, and net
benefits of regulations, and analyze the impacts of certain rules that
OSHA promulgates. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, reducing costs, harmonizing rules,
and promoting flexibility.
This final rule is not a ``significant regulatory action'' under
Executive Order 12866 or the UMRA. Neither the benefits nor the costs
of this final rule would exceed $100 million in any given year. On the
contrary, the possible effects of each provision on costs and benefits
appear to be relatively small, and OSHA has not been able to quantify
them. Nor has OSHA been able to quantify the cost savings it expects
from preventing misinterpretation and misapplication of the standard.
However, OSHA does expect that this final rule will increase
understanding and compliance with the standard and, therefore, the
agency expects the rule to result in some, unquantifiable cost savings.
Moreover, and as discussed above, OSHA expects this final rule will
maintain safety and health protections for workers.
1. Final Determinations Regarding Costs and Cost Savings Attributable
to the Final Rule
In the Preliminary Economic Analysis and Regulatory Flexibility Act
Certification (PEA) in the 2018 NPRM, OSHA considered whether each of
the proposed changes could affect the costs and, if so, how those costs
might be affected (83 FR at 63760-65). For the purposes of the
preliminary analysis, the agency divided the proposed changes into two
groups: (1) Proposed clarifications and (2) proposed revisions. The
``proposed clarifications'' were those that were solely intended to
clarify provisions and would not alter the requirements and scope of
the rule (83 FR at 63760-61). The items OSHA identified as
clarifications included the addition of a definition of beryllium
sensitization to paragraph (b); minor changes to the definitions of CBD
diagnostic center and chronic beryllium disease in paragraph (b); minor
changes to the written exposure control plan provisions in paragraphs
(f)(1)(i)(D) and (f)(1)(ii)(B); a minor change in the PPE removal
provision of paragraph (h)(2)(i); minor changes to provisions for the
cleaning of PPE in paragraph (h)(3)(iii); minor changes to the cleaning
of PPE upon entry to eating or drinking areas in paragraph (i)(4)(ii);
and minor changes to provisions for employee information and training
in paragraphs (m)(4)(ii)(A) and (m)(4)(ii)(E) (83 FR at 63760-61).
The ``proposed revisions,'' on the other hand, were those that
would go beyond clarification and alter certain requirements of the
beryllium standard (83 FR at 63761). The proposed provisions that OSHA
identified as revisions included changes to the definitions of
beryllium work area, confirmed positive, and dermal contact with
beryllium in paragraph (b); a change to the requirements for washing
facilities in paragraph (i)(1); a change to the requirements for
provision of change rooms in paragraph (i)(2); changes to the
requirements pertaining to disposal and recycling in paragraph (j)(3);
a change to the requirements for medical surveillance following an
employee's exposure to beryllium in an emergency in paragraph (k)(2);
revision to provisions for evaluation at a CBD diagnostic center in
paragraph (k)(7)(i); a change to the requirements for warning labels in
paragraph (m)(3); and changes to the requirements for recordkeeping in
paragraphs (n)(1)(ii)(F), (n)(3)(ii)(A), and (n)(4)(i).
After carefully reviewing the proposed clarifications and
revisions, OSHA preliminarily determined that their net total effect
would result in potential cost savings, mainly from improving employer
understanding and facilitating application of the rule (83 FR at 63760-
61). OSHA preliminarily identified a new potential cost, which would
result from the proposed changes as a whole: A de minimis cost for the
time employers would need to become familiar with the revised portions
of this final rule (83 FR at 63761, 63765). Viewing all the proposed
changes as a whole, OSHA explained that it preliminarily anticipated
that the proposed provisions' net effect would result in some cost
savings (83 FR at 63761). OSHA invited comment on all aspects of the
PEA, including these preliminary determinations (83 FR at 63760-62,
63764-65).
Stakeholders either agreed with or did not comment on OSHA's
analysis of potential costs and costs savings attributable to the vast
majority of the proposed clarifications and revisions (e.g., Document
ID 0026, pp. 1-2; 0038, pp. 21, 26, 32). The only objections the agency
received related to two of the four proposed paragraphs that OSHA is
revising from the proposal in the final rule: (1) The definition of the
term confirmed positive; and (2) the requirement related to
examinations at CBD diagnostic centers (Document ID 0021, p. 4; 0022,
pp. 5-6). Those comments, and OSHA's final determination that each of
the four paragraphs that OSHA is revising from the proposal will result
in small and unquantifiable cost savings, are discussed in detail
below.
OSHA has also examined the record concerning the proposed
clarifications and revisions that OSHA has finalized without change. As
noted above, stakeholders either agreed with or did not comment on
OSHA's analysis of potential costs and costs savings attributable to
these proposed changes. Therefore, after carefully considering all the
comments received and the remainder of the record, OSHA affirms its
preliminary determination that these clarifications and revisions are
likely to result in cost savings, largely from improving employer
understanding and facilitating application of the rule. OSHA also
affirms its preliminary determination that the only potential new costs
are de minimis costs for the time employers would need to become
familiar with the revised portions of this final rule.
In summary, OSHA finds that both the four paragraphs that OSHA is
revising from the proposal and the remainder of the proposed
clarifications and revisions that OSHA is finalizing without change in
the final rule will result in potential cost savings mainly
attributable to improving employer understanding and facilitating
application of the rule, as well as preventing costs that would follow
from misunderstanding the standard. OSHA expects that the cost savings
attributable to these changes will offset the de minimis employer
familiarization costs, resulting in a net result of cost savings.
Therefore, OSHA finds that this final rule is likely to result in cost
savings.
2. Analysis of Costs and Costs Savings Attributable to Provisions in
the Final Rule That Differ From Those in the Proposal
In this section the agency discusses the four changes in the final
rule that differ from the proposal: The definition of confirmed
positive in paragraph (b), Definitions; a clarification to inter-plant
transfers in paragraph (j), Housekeeping; and two changes to paragraph
(k), Medical Surveillance: Requirements related to CBD diagnostic
centers and requirements for medical examination at termination of
employment. In all cases, as stated above, the agency has determined
these will have de minimis cost or cost savings implications.
Definition of Confirmed Positive.
The 2017 final rule did not specify a time limit within which the
BeLPT tests that contribute toward a finding of ``confirmed positive''
must occur. In the 2018 NPRM, OSHA proposed to modify the definition of
confirmed positive to require that the qualifying test results be
obtained within one testing cycle (including the 30-day follow-up test
period required after a first abnormal or borderline BeLPT test
result), rather than arguably over an unlimited time period that might
have led to false positives that could needlessly concern workers and
their families, could lead workers to undergo unnecessary testing, and
would not enhance worker protections. In the PEA, OSHA explained that
the exact effect of the proposed change was uncertain as it is unknown
how many employees would have a series of BeLPT results associated with
a confirmed positive finding (two abnormal results, one abnormal and
one borderline result, or three borderline results) over an unlimited
period of time, but would not have any such combination of results
within a single testing cycle (83 FR at 63761-62). OSHA preliminarily
concluded that the proposed change would not increase compliance costs
and would incidentally yield some cost savings by lessening the
likelihood of false positives (83 FR at 63762). The agency invited
comment on its preliminary conclusion (83 FR at 63762).
As discussed in Section XI, Summary and Explanation for paragraph
(b), a number of stakeholders commented that requiring results within a
30-day testing cycle could create logistical challenges, for example
due to repeat testing requirements or for businesses in remote areas
with limited healthcare facilities (Document ID 0022, p. 4; 0021, p. 4;
0024, p. 1; 0033, p. 5; 0027, p. 3). National Jewish Health (NJH) also
commented that removing the time frame of 30 days for confirming
abnormal results would allow for employee workplace protection and
clinical evaluation referral at a lower cost and with less logistical
burden (Document ID 0022, p. 5).
Stakeholders' logistical concerns and NJH's comment about costs
reflect a misunderstanding of the proposed change. As explained in more
detail in the Summary and Explanation for paragraph (b), OSHA did not
intend that the initial and any follow-up tests had to be completed and
interpreted within 30 days. Rather, the agency intended that the test
results be obtained during one cycle of testing, that is, an initial or
periodic examination followed by follow-up testing conducted within 30
days of an abnormal or borderline result. For example, if an employee
received a borderline BeLPT result at his or her periodic examination,
paragraph (k)(3)(ii)(E) would require the employer to offer a follow-up
BeLPT within 30 days of the test results. If the follow-up BeLPT result
was also borderline, paragraph (k)(3)(ii)(E) would again require the
employer to offer a follow-up BeLPT within 30 days of the first follow-
up test's results. If that second follow-up was borderline or abnormal,
the employee would have been confirmed positive under the proposal
because all of the tests that ``confirmed'' the results were triggered
by the initial test. In other words, OSHA did not intend to suggest
that the proposal would have required employers to conduct all of the
tests or obtain the confirming results within a single 30-day period.
In this final rule, OSHA has revised the definition of confirmed
positive to specify that the findings of two abnormal, one abnormal and
one borderline, or three borderline results must be obtained from
BeLPTs conducted within a three-year period. OSHA determined that this
revision strikes the appropriate balance between the shorter time
period for confirmation in the proposal and the unspecified, arguably
indefinite, time period of the original definition. As explained in the
Summary and Explanation section, the final three-year period will
capture the identification of sensitized workers enrolled in medical
surveillance. OSHA finds that the addition of a specific time period to
the text of the final rule will decrease the possibility of a
misinterpretation of the provision's time frame that could lead to
false positive results.
As with the proposed revisions to this definition, OSHA finds that
the exact effect of this change is uncertain because it is unknown how
many employees would have a series of BeLPT results associated with a
confirmed positive finding (two abnormal results, one abnormal and one
borderline result, or three borderline results) over an unlimited
period of time, but would not have any such combination of results
within a three-year testing cycle, though it is likely to be small. As
discussed in Section XI, Summary and Explanation of the Final Rule, NJH
reported that in a group of 194 CBD patients in their care, the length
of time between abnormal results ranged from 14 days to 5.8 years, with
a 95th percentile of 2.9 years. This suggests that the vast majority of
individuals who will have two abnormal BeLPT tests in the course of
medical surveillance are likely to be confirmed positive within the
three-year window of time OSHA is establishing in the definition of
confirmed positive. The Summary and Explanation section notes further
that a three-year testing cycle is consistent with practices and
recommendations of the medical community, pointing to the increasing
likelihood that a confirmed positive finding over longer periods of
time will be a false-positive and lead to costly further medical exams
with no benefit. Thus, OSHA concludes that this change will not
increase compliance costs and will incidentally yield some cost savings
by lessening the likelihood of false positives.
Disposal, Recycling, and Reuse.
Paragraph (j)(3) of the previous standard (29 CFR 1910.1024(j)(3))
addresses disposal and recycling of materials that contain beryllium in
concentrations of 0.1 percent by weight or more or that are
contaminated with beryllium. In the 2018 NPRM, OSHA proposed to modify
this paragraph in a number of ways--all of which the agency
preliminarily found would not increase the costs of complying with the
standard and may also result in unquantifiable savings to employers by
preventing misinterpretation or misapplication of the rule (83 FR at
63762-63). Stakeholders did not offer any comments objecting to this
preliminary determination. With the exception of one minor
clarification to the regulatory text, discussed below, OSHA is adopting
all of the proposed revisions to paragraph (j)(3) in this final rule.
After reviewing the record as a whole and having received no evidence
or comment to the contrary, the agency reaffirms its preliminary
determination that the proposed revisions to paragraph (j)(3) that are
being adopted in this final rule will result in some cost savings from
increased employer understanding.
OSHA has made one change to the proposed provisions in paragraph
(j)(3) in this final rule. When employers transfer certain materials to
another party for disposal, recycling, or reuse, proposed paragraph
(j)(3)(i) would have required employers to label the materials in
accordance with paragraph (m)(3) of the standard. As explained in the
Summary and Explanation for paragraph (j)(3), a comment alerted the
agency to a potential ambiguity in this proposed text. Specifically,
OSHA realized that the phrase ``to another party'' could be read to
suggest that transfers between two facilities owned by the same
employer are exempted from the labeling requirements in paragraph
(j)(3)(i). That was not the agency's intent in the proposal. To
eliminate any ambiguity on this point, OSHA revised paragraph (j)(3)(i)
in the final rule to strike the phrase ``to another party'' and add the
``except for intra-plant transfers'' language that is found in
paragraphs (j)(3)(ii) and (iii).
As with the proposed changes to paragraphs (j)(3)(ii) and (iii),
which clarified that those paragraphs' requirements did not apply to
intra-plant transfers, OSHA finds that this proposed change is not a
substantive change to the standard. It is simply clarifying OSHA's
original intent that all transfers outside of a plant, including
between facilities owned by the same employer, are subject to the
labeling requirements of paragraph (m)(3). Since this change does not
alter the requirements of the standard, it will not affect the costs of
compliance with the standard. Therefore, OSHA finds that none of the
changes this final rule makes to paragraph (j)(3) will increase the
costs of complying with the standard.
Medical Surveillance.
In the 2018 NPRM, OSHA proposed two sets of changes to paragraph
(k). The first set of changes proposed is in paragraph (k)(2), which
specifies when and how frequently medical examinations are to be
offered to those employees covered by the medical surveillance program.
Paragraph (k)(2)(i)(B) of the previous standard required the employer
to provide a medical examination within 30 days after determining that
the employee shows signs or symptoms of CBD or other beryllium-related
health effects or that the employee has been exposed to beryllium in an
emergency.
Based on stakeholder feedback and other evidence indicating that
the 30-day period in the previous standard may be insufficient to
detect beryllium sensitization in individuals exposed one time in an
emergency, OSHA proposed removing the requirement for a medical
examination within 30 days of exposure to beryllium during an
emergency, under paragraph (k)(2)(i)(B), and adding paragraph
(k)(2)(iv), which would require the employer to offer a medical
examination at least one year after but no more than two years after
the employee is exposed to beryllium during an emergency (83 FR at
63757).
In the PEA, OSHA preliminarily determined that the net cost impact
of these proposed changes would be slight, with some possible cost
savings. Specifically, OSHA explained that, in the FEA for the 2017
final rule, the agency estimated that emergencies would affect a very
small number of employees in a given year, likely less than 0.1 percent
of the affected population, representing a small addition to the costs
of medical surveillance for the standard (Document ID OSHA-H005C-2006-
0870-2042, p. V-196). Under the 2017 final rule, some employees might
have required two examinations to be confirmed positive: A first test
cycle within the initial 30-day period and a second BeLPT at least two
years later. Under the 2018 NPRM, OSHA expected that more of the
employees who became sensitized from exposure in an emergency would be
confirmed positive through a single testing cycle because that test
would have been administrated one to two years following the emergency.
The agency anticipated that the proposed change would result in the
elimination of one premature testing, which would ensure better
detection for more employees and incidentally trigger some cost savings
(83 FR at 63764).\3\
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\3\ Assuming that this initial analysis does not result in a
confirmed positive diagnosis, that employee would not be confirmed
positive until a second test two years later under the current rule.
---------------------------------------------------------------------------
To the extent that lengthening the time period in which the test
must be offered from within 30 days to between one and two years leads
to earlier confirmed positive results (within two years, as opposed to
within two years plus 30 days), OSHA preliminarily found that the
proposed change could slightly accelerate costs to the employer for
earlier CBD diagnostic center referral and medical removal protection.
OSHA estimated that the proposed change would affect a very small
percentage of an already very small population. The agency
preliminarily determined that the proposed revision would only
potentially change the timing of the already-required BeLPT, CBD
diagnostic center referral, and medical removal protection (83 FR at
63764, 63764 n.5).
In summary, OSHA preliminarily found that the end result of the
proposed changes to paragraph (k)(2) from a cost perspective would be
that the cost savings from the potential avoidance of a premature BeLPT
within 30 days following an emergency would likely be largely canceled
out by the acceleration of the cost of the CBD diagnostic center
evaluation and medical removal protection. Therefore, OSHA
preliminarily determined that the net cost impact of the proposed
changes would be slight, with some possible cost savings (83 FR at
63764). Stakeholders did not submit any comments related to OSHA's
preliminary determinations regarding potential costs of the proposed
revisions to paragraph (k)(2).
In sum, after considering the record as a whole, OSHA finds that
its preliminary estimates were correct: A small change in costs, with
possible cost savings. Nevertheless, as discussed in more detail in the
Summary and Explanation for paragraph (k), Medical Surveillance, some
stakeholders expressed concerns about possible delays in medical
consultations and examinations and lack of employee knowledge of
potential health effects, and one stakeholder argued that employees who
terminate employment before receiving the post-emergency examination
might not receive an examination at all after being exposed in an
emergency (Document ID 0023, pp. 2-3; 0024, p. 2; 0027, p. 4).
OSHA is revising paragraphs (k)(2) in the final rule in two ways to
address these concerns. First, OSHA has added two sub-provisions under
paragraph (k)(2)(iv) to provide for post-emergency examination timing
for two separate groups of employees. Final paragraph (k)(2)(iv)(A)
focuses on the very small group of employees who are exposed in an
emergency but have not received a medical examination under paragraph
(k)(1)(i) within the previous two years. The requirement for these
employees is similar to the requirement contained in the previous
standard; i.e., under the final standard, the employer must provide
these employees with a medical examination within 30 days of the date
of the emergency. Because the final standard treats these employees
similarly to the manner in which the previous standard treated all
employees exposed in an emergency, OSHA does not expect that there will
be any change in cost attributable to this change. In other words, for
those employees who have not had a medical examination within the past
two years there is no change in protocol and, thus, no change in costs.
Final paragraph (k)(2)(iv)(B) focuses on employees who are exposed
during an emergency, but have recently received an examination. Under
this new provision, if an employee has received a medical examination
under paragraph (k)(1)(i) within the previous two years, then the
employer would be required to offer that employee a medical examination
that meets the requirements of the standard at least one year but no
more than two years after the employee was exposed to beryllium in an
emergency. Because this provision treats employees who have recently
received an examination similarly to the manner in which the proposal
would have treated all employees exposed in an emergency, OSHA expects
that this change will result in a fraction of the small cost savings
preliminarily estimated in the proposal.
Second, to address concerns that delaying the medical examination
to at least one year and no more than two years following the emergency
may result in employees not receiving a post-emergency examination if
their employment ends soon after exposure during an emergency, OSHA is
revising paragraph (k)(2)(iii) to require that each employee who is
exposed in an emergency and has not received an examination since the
emergency exposure is provided an examination at the time employment is
terminated. Because paragraph (k)(2)(iii) already requires an
examination at termination if there has not been one within the last
six months due to any of the standard medical exam triggers, including
emergency exposure, OSHA expects that this change will affect an
extremely small group of employees. This revision, however, will ensure
that all employees with emergency exposure are offered a medical exam,
even under this very narrow set of circumstances. The baseline of costs
and cost savings of this analysis is the previous rule, which already
required a medical exam within 30 days of emergency exposure. Thus,
OSHA does not expect that this change will have any cost implications.
In summary, OSHA finds that this final rule's revisions to
paragraph (k)(2) will result in slight cost savings. No costs or costs
savings are attributable to new paragraph (k)(2)(iv)(A), which treats
employees exposed in an emergency who have not received a medical
examination within the previous two years pursuant to paragraph
(k)(1)(i) similarly to how all employees exposed in an emergency were
treated under the previous standard. The end result of final paragraph
(k)(2)(iv)(B), however, will be cost savings from the potential
avoidance of a premature BeLPT that are largely offset by the
acceleration of the cost of the CBD diagnostic center evaluation and
medical removal protection. OSHA does not attribute any costs or cost
savings to result from the revisions to paragraph (k)(2)(iii).
Therefore, the agency expects the new result of final paragraph (k)(2)
to be a slight cost savings.
The second set of changes proposed to the standard's medical
surveillance requirements is in paragraph (k)(7), which contains the
requirements for evaluation at a CBD diagnostic center. Paragraph
(k)(7)(i) of the previous rule required employers to provide an
evaluation at no cost to the employee at a CBD diagnostic center that
is mutually agreed upon by the employee and employer within 30 days of
the employer receiving a written medical opinion that recommends
referral to a CBD diagnostic center, or a written medical report
indicating that the employee has been confirmed positive or diagnosed
with CBD. To address stakeholder concerns that scheduling the
appropriate tests with an examining physician at the CBD diagnostic
center may take longer than 30 days, OSHA proposed that the employer
provide an initial consultation with the CBD diagnostic center, rather
than the full evaluation, within 30 days of the employer receiving one
of the types of documentation listed in paragraph (k)(7)(i)(A) or (B).
The agency noted that the consultation could occur via telephone or
virtual conferencing methods and would demonstrate that the employer
made an effort to begin the process for a medical examination (83 FR at
63758). Evaluation and any testing would then occur within a reasonable
time after the consultation.
In the PEA, OSHA noted that while the addition of the consultation
would not result in any additional costs or cost savings (since the
2017 FEA had already accounted for a 15-minute discussion between the
employee and a physician (Document ID OSHA-H005C-2006-0870-2042, p. V-
206)), allowing more flexibility in scheduling the tests at the CBD
diagnostic center would enable employers to find more economical travel
and accommodation options. To the extent that it takes longer than 30
days to schedule the tests at the CBD diagnostic center, the agency
preliminarily found that employers may realize a cost savings due to
retaining funds during the delay. OSHA could not quantify the effect of
this flexibility, however, concluding only that it expected that the
changes would produce minor, if any, cost savings. The agency invited
comment on its preliminary assessment of these potential effects (83 FR
at 63764).
Stakeholders did not offer any comments on the agency's preliminary
estimates regarding the cost savings attributable to these proposed
changes. Several commenters objected to adding the consultation
requirement, however, arguing that it was an unnecessary step that
would add logistical complications and costs (see, e.g., Document ID
0021, p. 3; 022, p. 6). This is discussed in more detail in the Summary
and Explanation for paragraph (k), Medical Surveillance. After
considering these comments and the record as a whole, OSHA decided to
modify paragraph (k)(7)(i) to require that the employer within 30 days
of receiving one of the types of documentation listed in paragraph
(k)(7)(i)(A) or (B) schedule an evaluation at a CBD diagnostic center.
In addition, OSHA is adding a requirement that the evaluation itself
must occur within a reasonable time.
OSHA finds that these changes may slightly delay the incidence of
costs of an evaluation under paragraph (k)(7)(i), in that it may occur
at a later date in some cases than under the existing provision. This
would slightly decrease the costs of compliance with the standard. The
agency also finds that allowing the evaluation to occur within a
reasonable time, rather than within 30 days, may allow for more cost-
effective travel and accommodation options. Thus, as with the proposal,
OSHA concludes that these changes may produce minor cost savings.
To account for a proposed change to the definition of CBD
diagnostic center, the proposed rule would also have amended paragraph
(k)(7)(i) to clarify that the employer must provide, at no cost to the
employee and within a reasonable time after consultation with the CBD
diagnostic center, any of the following tests that a CBD diagnostic
center must be capable of performing, if deemed appropriate by the
examining physician at the CBD diagnostic center: A pulmonary function
test as outlined by American Thoracic Society criteria testing,
bronchoalveolar lavage (BAL), and transbronchial biopsy. In the PEA,
OSHA explained that this proposed change would not alter the
requirements of the standard and therefore would not change the costs
of compliance with the standard (83 FR at 63764).
Stakeholders did not offer any comments on OSHA's determination
that these proposed changes would not affect costs. Some stakeholders
argued, however, that the proposed provision could be misinterpreted to
mean that the employer does not have to make available other tests that
the examining
physician deems appropriate for reasons such as diagnosing or
determining the severity of CBD (Document ID 0021, p. 3; 0022, p. 3;
0028, p. 2). This is discussed in more detail in the Summary and
Explanation for paragraph (k), Medical Surveillance. To address these
concerns, OSHA is adding a new provision, paragraph (k)(7)(ii), which
clarifies that, as part of the evaluation at the CBD diagnostic center,
the employer must ensure that the employee is offered any tests deemed
appropriate by the examining physician at the CBD diagnostic center,
such as pulmonary function testing as outlined by American Thoracic
Society criteria testing, bronchoalveolar lavage (BAL), and
transbronchial biopsy.\4\ If any of these tests deemed appropriate by
the examining physician are not available at the CBD diagnostic center,
the final rule allows them to be performed at another location that is
mutually agreed upon by the employer and the employee.
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\4\ As discussed in Section XI, Summary and Explanation of the
Final Rule, OSHA also redesignated previous paragraphs (k)(7)(ii),
(iii), (iv), and (v) as paragraphs (k)(7)(iii), (iv), (v), and (vi),
respectively. This redesignation in paragraph (k) also affects a
reference in paragraph (l)(1)(ii). These changes are merely
administrative and do not have any substantive or monetary effect.
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OSHA does not believe that requiring employers to provide any tests
deemed appropriate by the examining physician would change the costs of
compliance with the standard because the agency accounted for such
costs in the 2017 final rule.\5\ Specifically, when calculating the
unit cost for going to a CBD diagnostic center in the 2017 FEA, the
agency used a typical suite of tests that would be performed (Document
ID OSHA-H005C-2006-0870-2042, p. V-205). Consequently, OSHA's unit cost
in the 2017 final rule for an evaluation at a CBD diagnostic center was
an average for standard tests that are required. The agency finds that
this average set of tests by definition is constructed to give the
average cost for the tests deemed appropriate by the examining
physician and, thus, concludes that there are no costs or cost savings
attributable to this change.
---------------------------------------------------------------------------
\5\ As discussed in the Summary and Explanation for paragraph
(k), Medical Surveillance, OSHA never intended to limit the required
tests to the three tests listed in the previous definition of the
term CBD diagnostic center.
---------------------------------------------------------------------------
Paragraph (k)(7)(ii) requires that if any test deemed appropriate
by the examining physician is not available at the CBD diagnostic
center, the test must be performed at another location that is mutually
agreed to by the employer and employee. OSHA believes that such
circumstances would be very rare. CBD diagnostic centers with the
ability to perform pulmonary function testing (as outlined by the
American Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy are most likely to also provide other medical
tests related to CBD.\6\ As a result, the CBD diagnostic center in the
vast majority of cases will be able to offer the additional testing
deemed necessary by the examining physician. Moreover, because the
three tests noted above are the tests that are commonly needed to
diagnose CBD, OSHA expects that these are the tests that would most
commonly be performed (see Section XI, Summary and Explanation of the
Final Rule). Given that this standard requires CBD diagnostic centers
to be able to perform the three tests that are most commonly performed
to diagnose CBD and CBD diagnostic centers typically would be able to
offer any additional tests deemed necessary, OSHA expects that
employees would rarely, if ever, need to travel to a second
location.\7\ In those rare cases, the added flexibility of having the
tests performed outside of a CBD diagnostic center gives more options
for the employer and employee and should lead to cost savings. Because
this situation should be quite uncommon, OSHA expects that the cost
savings of allowing employees to have additional tests outside of a CBD
diagnostic center are likely to be de minimis.
---------------------------------------------------------------------------
\6\ Document ID OSHA-H005C-2006-0870-0637 provides some
information from the NJH website, which provides an overview of the
types of tests performed.
\7\ OSHA also notes that it has always intended for employers to
make available any additional tests deemed appropriate by the
examining physician (see the discussion of paragraph (k), Medical
Surveillance, in Section XI, Summary and Explanation of the Final
Rule, of this preamble). The economic analysis of the 2017 final
rule did not explicitly account for these rare cases where a test
recommended by the examining physician of the CBD diagnostic center
was not available at the same center. Hence, there would be a de
minimis cost adjustment increase of the total cost of the 2017 final
rule due to this consideration. This is not a change in people's
behavior, simply a methodological change. The current final rule
could affect people's behavior and be a true change (decrease) in
costs. This change merely provides employers with a more flexible,
potentially less expensive, manner to provide those tests in the
rare situation where they are not available at the original CBD
diagnostic center.
---------------------------------------------------------------------------
This change to paragraph (k)(7) clarifies OSHA's intent that the
employer provide any tests deemed appropriate by the examining
physician at the CBD diagnostic center, or at another location if not
available at the CBD diagnostic center, but does not substantively
change the requirements of the beryllium standard. OSHA expects that
the changes described here would maintain safety and health protections
for workers.
3. Economic and Technological Feasibility
In the FEA in support of OSHA's 2017 Beryllium Final Rule, OSHA
concluded that the general industry beryllium standard was economically
and technologically feasible (see 82 FR at 2471). In the 2018 NPRM,
OSHA explained that it anticipated that none of the proposed changes
would impose any new employer obligations or increase the overall cost
of compliance, while some of the changes would clarify and simplify
compliance in such a way that results in cost savings. In addition,
OSHA preliminarily anticipated that the de minimis cost of any time
spent reviewing the proposed changes would be more than offset by the
cost savings described in the PEA. OSHA further found that none of the
proposed revisions would require any new controls or other technology.
OSHA therefore preliminarily determined that the proposed rule was both
economically and technologically feasible. OSHA did not receive any
comments objecting to or otherwise questioning this preliminary
determination.\8\ Therefore, after considering the record as a whole,
OSHA finds that the proposed provisions that are being adopted in this
final rule are economically and technologically feasible.
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\8\ Although the agency did not receive any comments questioning
the economic or technological feasibility of the proposed changes,
at least one stakeholder argued that the previous standard was not
economically or technologically feasible and that the proposed
provisions remedied some of that stakeholder's concerns with
feasibility (Document ID 0038, pp. 13, 21-22, 43). Because the
feasibility of the January 2017 final rule as a whole is not at
issue in this rulemaking, OSHA considers these comments indicating
that these changes provide both economic and technological
feasibility relief as support for the economic and technological
feasibility of the proposed revisions.
---------------------------------------------------------------------------
OSHA also finds that the few new changes between the proposal and
the final rule would not require any new controls or other technology
and will result in cost savings. Therefore, OSHA finds that these final
provisions, and the final rule as a whole, are economically and
technologically feasible.
4. Effects on Benefits
In the 2017 FEA, OSHA attributed approximately 67 percent of the
beryllium sensitization cases and the CBD cases avoided, and none of
the lung cancer cases avoided, solely to the ancillary provisions of
the standard (Document ID OSHA-H005C-2006-0870-2042, pp. VII-4 to VII-
5, VII-24). This estimate was based on the ancillary provisions as a
whole, rather than each provision separately.
In the PEA, OSHA considered the potential effect of each proposed
change to ancillary provisions on employee protections. Because the
proposed revisions to the standard would not remove or change the
general nature of any ancillary provisions, and because the agency
expected the proposed revisions to maintain safety and health
protections for workers and facilitate employer understanding and
compliance, OSHA preliminarily determined that the proposed changes
would increase the standard's benefits as a whole by enhancing worker
protections overall and by preventing costs that follow from
misunderstanding the standard.
OSHA did not receive any comments related to its preliminary
assessment of the proposed provisions' effects on benefits. Having
considered the record as a whole, including all the comments received,
OSHA finds that the changes in this final rule will maintain safety and
health protections for workers while aligning the standard with the
intent behind the 2017 final rule and otherwise preventing costs that
could follow from misinterpretation or misapplication of the standard.
And the agency reaffirms its determination that facilitating employer
understanding and compliance has the benefit of enhancing worker
protections overall. Therefore, OSHA finds that the changes in this
final rule will increase the benefits of the standard as a whole.
5. Regulatory Flexibility Act Certification
In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et
seq. (as amended), OSHA has examined the regulatory requirements of
this final rule to revise the general industry beryllium standard to
determine whether they would have a significant economic impact on a
substantial number of small entities. The final rule modifies the
general industry standard to clarify certain provisions and simplify or
improve compliance. It does not impose any new duties or increase the
overall cost of compliance, and OSHA expects it will provide some cost
savings. OSHA therefore expects that this final rule will not have a
significant economic impact on any small entities. Accordingly, OSHA
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities.
V. Office of Management and Budget (OMB) Review Under the Paperwork
Reduction Act of 1995
A. Overview
This final rule revises information collection (paperwork)
requirements in the occupational exposure to beryllium in general
industry (29 CFR 1910.1024) standard that are subject to Office of
Management and Budget (OMB) approval under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.) and its implementing regulations
(5 CFR part 1320). OSHA is revising the previously approved paperwork
package under OMB control number 1218-0267, as it pertains to general
industry only. The collection of information items contained in the
Information Collection Request (ICR) pertaining to occupational
exposure to beryllium in the construction and shipyard sectors remain
in the ICR without change.
The PRA generally requires that agencies consider the impact of
paperwork and other information collection burdens imposed on the
public, obtain public input, and obtain approval from OMB before
conducting any collection of information (44 U.S.C. 3507). The PRA
defines a collection of information as ``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)). Federal agencies generally
cannot conduct or sponsor a collection of information, and the public
is generally not required to respond to an information collection,
unless it is approved by OMB under the PRA and displays a valid OMB
control number (44 U.S.C. 3507). Also, notwithstanding any other
provision of law, no person shall be subject to penalty for failing to
comply with a collection of information if the collection of
information does not display a valid OMB control number (44 U.S.C.
3512).
B. Solicitation of Comments
On January 9, 2017, OSHA published a final rule establishing new
permissible exposure limits and other provisions to protect employees
from beryllium exposure, such as requirements for exposure assessment,
respiratory protection, personal protective clothing and equipment,
housekeeping, medical surveillance, hazard communication, and
recordkeeping for the general industry, construction, and shipyard
sectors. OMB approved the collections of information contained in the
final rule under OMB Control Number 1218-0267.
On December 11, 2018, OSHA published a Notice of Proposed
Rulemaking (NPRM) to modify the general industry beryllium standard by
clarifying certain provisions to improve and simplify compliance (83 FR
63746). The 2018 NPRM proposed to revise the collections of information
contained in the general industry standard by modifying provisions for
the written exposure control plan; the cleaning and replacement of
personal protection equipment; the disposal, recycling, and reuse of
contaminated materials; certain aspects of medical surveillance; and
the collection of social security numbers in recordkeeping. OSHA
prepared and submitted to OMB an ICR for the 2018 proposed rule for
review in accordance with 44 U.S.C. 3507(d). A copy of the proposed ICR
is available to the public at http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267.
In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited
public comments on the collection of information contained in the 2018
proposed rule. OSHA encouraged commenters to submit their comments on
the information collection requirements contained in the proposed rule
under docket number OSHA-2018-0003, along with their comments on other
parts of the proposed rule. In addition to generally soliciting
comments on the collection of information requirements, the proposed
rule indicated that OSHA and OMB were particularly interested in the
following items:
Whether the proposed collection of information is
necessary for the proper performance of the agency's functions,
including whether the information is useful;
The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
The quality, utility, and clarity of the information to be
collected; and
Ways to minimize the compliance burden on employers, for
example, through the use of automated or other technological techniques
for collecting and transmitting information (83 FR 63766).
On March 29, 2019, OMB issued a Notice of Action (NOA) stating,
``Terms of the previous clearance remain in effect. OMB is withholding
approval at this time. 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'' (see OMB
Conclusion Action on ICR Reference No. 201812-1218-001, dated March 29,
2019, available at: https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267).
The agency did not receive any public comments in response to the
proposed ICR submitted to OMB for review. Public comments submitted in
response to the NPRM, however, substantively addressed provisions
containing collection of information. OSHA considered these comments
when it developed the revised ICR for this final rule. Summaries of
comments received on the NPRM and OSHA's responses are found in
Sections XI, Summary and Explanation of the Final Rule, and IV, Final
Economic Analysis and Regulatory Flexibility Act Certification.
The Department of Labor submitted the final ICR concurrent with the
publication of this final rule, containing the full analysis and
description of the burden hours and costs associated with the final
rule, to OMB for approval. A copy of this ICR will be available to the
public at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202006-1218-006 (this link will become active on the day following publication
of this notice). At the conclusion of OMB's review, OSHA will publish a
separate notice in the Federal Register to announce the results.
C. Summary of Information Collection Requirements
As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the
following paragraphs provide information about the ICR.
1. Title: Beryllium Standard for General Industry (29 CFR
1910.1024), Construction (29 CFR 1926.1124), and Maritime (29 CFR
1915.1024).
2. Type of Review: Revision.
3. OMB Control Number: 1218-0267.
4. Affected Public: Business or Other For-Profit. This final rule
applies to employers in general industry 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).
5. Occupational Exposure to Beryllium in General Industry only:
a. Number of Respondents: 4,538.
b. Frequency of Responses: On occasion, quarterly, semi-annually,
annually, biannually.
c. Number of Responses: 134,570.
d. Estimated Total Burden Hours: 82,822.
e. Estimated Cost: $18,741,540.
6. Occupational Exposure to Beryllium in Construction and Shipyard
Sectors (previously-approved costs not affected by this rulemaking):
a. Number of Respondents: 2,796.
b. Frequency of responses: On occasion, quarterly, semi-annually,
annually, biannually.
c. Number of responses: 39,420.
d. Estimated Total Burden Hours: 25,269.
e. Estimated Cost: $8,774,874.
7. Total Estimated Burden Hours and Cost for All Three Industries:
a. Estimated Total Number of responses: 173,990.
b. Estimated Total Burden Hours: 108,091.
c. Estimated Cost: $27,516,414.
D. Summary of Changes in the Collection of Information Requirements
This final standard for occupational exposure to beryllium and
beryllium compounds in general industry revises the collection of
information requirements contained in the existing ICR for general
industry, approved under OMB control number 1218-0267. OSHA is updating
the new ICR to reflect those changes, which include changes to the
written exposure control plan; the cleaning and replacement of personal
protection equipment; the disposal, recycling, and reuse of
contaminated materials; certain aspects of medical surveillance; and
the collection of Social Security numbers in recordkeeping (see Table
V.1 below). The majority of these changes were adopted by the agency as
proposed. However, in response to comments on the proposed rule, OSHA
has revised a few of the provisions of the final rule that affect the
collection of information. Those changes are also noted in Table V.1
below.
Table V.1--Changes to Collection of Information Requirements in the
Final Rule for General Industry
------------------------------------------------------------------------
Explanation of this final
Information collection requirements in this rule's changes to the
final rule information collection
requirements
------------------------------------------------------------------------
Sec. 1910.1024(f)(1)(i), (ii), & (iii)-- This final rule removed
Methods of Compliance--Written Exposure the word ``preventing''
Control Plan. from (f)(i)(D), which
(i) The employer must establish, implement, previously contained the
and maintain a written exposure control phrase ``including
plan, which must contain:. preventing the transfer
(A) A list of operations and job titles of beryllium.'' In
reasonably expected to involve airborne addition, the final rule
exposure to or dermal contact with revised (f)(1)(ii)(B) by
beryllium;. replacing the phrase
(B) A list of operations and job titles ``airborne exposure to
reasonably expected to involve airborne or dermal contact with
exposure at or above the action level;. beryllium'' with
(C) A list of operations and job titles ``exposure to
reasonably expected to involve airborne beryllium.'' Both of
exposure above the TWA PEL or STEL;. these changes were
adopted as proposed.
(D) Procedures for minimizing cross-
contamination, including 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 for evaluation at a CBD
diagnostic center, or shows signs or
symptoms associated with exposure to
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)).
Sec. 1910.1024(h)(3)(iii)--Personal This final rule revised
Protective Clothing and Equipment--Cleaning (h)(3)(iii) by replacing
and Replacement. the phrase ``airborne
(3)(iii) The employer must inform in writing exposure to and dermal
the persons or the business entities who contact with beryllium''
launder, clean, or repair the personal with ``exposure to
protective clothing or equipment required by beryllium.'' This change
this standard of the potentially harmful was adopted as proposed.
effects of exposure to beryllium and that
the personal protective clothing and
equipment must be handled in accordance with
this standard..
Sec. 1910.1024(j)(3)(i), (ii), & (iii)-- This final rule revised
Housekeeping--Disposal, recycling, and reuse. (j)(3) by explicitly
(3)(i) Except for intra-plant transfers, when addressing transferring
the employer transfers materials that materials for reuse;
contain at least 0.1% beryllium by weight or reorganizing the
are contaminated with beryllium for previous two provisions
disposal, recycling, or reuse, the employer into three to allow the
must label the materials in accordance with agency to incorporate
paragraph (m)(3) of this standard;. the new reuse
(ii) Except for intra-plant transfers, requirements, while also
materials designated for disposal that setting out each
contain at least 0.1% beryllium by weight or distinct obligation
are contaminated with beryllium must be clearly; replacing the
cleaned to be as free as practicable of phrase materials ``that
beryllium or placed in enclosures that contain beryllium in
prevent the release of beryllium-containing concentrations of 0.1
particulate or solutions under normal percent by weight or
conditions of use, storage, or transport, more'' with a shorter,
such as bags or containers; and. easier to understand
(iii) Except for intra-plant transfers, phrase: Materials ``that
materials designated for recycling or reuse contain at least 0.1
that contain at least 0.1% beryllium by percent beryllium by
weight or are contaminated with beryllium weight;'' clarifying
must be cleaned to be as free as practicable that the rule's
of beryllium or placed in enclosures that requirements for
prevent the release of beryllium-containing disposal, recycling, and
particulate or solutions under normal reuse do not apply to
conditions of use, storage, or transport, intra-plant transfers;
such as bags or containers.. clarifying the enclosure
requirements by
providing more detail on
what constitutes an
appropriate enclosure;
allowing for the
cleaning of materials
bound for disposal; and
removing the undefined
phrase ``surface
beryllium
contamination.''
In addition to the above
actions, which were all
adopted as proposed, in
this final rule, OSHA
revised paragraph
(j)(3)(i) to explicitly
incorporate the
clarification that the
rule's requirements for
disposal, recycling, and
reuse do not apply to
intra-plant transfers.
Sec. 1910.1024(k)(2)--Medical Surveillance. Paragraph (k)(2)(i)(B) of
(2) Frequency. the 2017 standard
The employer must provide a medical previously required the
examination:. employer to provide a
(i) Within 30 days after determining that:... medical examination
(A) An employee meets the criteria of within 30 days after
paragraph (k)(1)(i)(A), unless the employee determining that the
has received a medical examination, provided employee shows signs or
in accordance with this standard, within the symptoms of CBD or other
last two years; or. beryllium-related health
(B) An employee meets the criteria of effects or that the
paragraph (k)(1)(i)(B) of this standard.. employee has been
(ii) At least every two years thereafter for exposed to beryllium in
each employee who continues to meet the an emergency. The 2018
criteria of paragraph (k)(1)(i)(A), (B), or NPRM would have added
(D) of this standard.. paragraph (k)(2)(iv) to
(iii) At the termination of employment for require employers to
each employee who meets any of the criteria offer an examination to
of paragraph (k)(1)(i) of this standard at employees exposed to
the time the employee's employment beryllium in an
terminates, unless an examination has been emergency at least one
provided in accordance with this standard year after but no more
during the six months prior to the date of than two years after the
termination. Each employee who meets the employee is exposed to
criteria of paragraph (k)(1)(i)(C) of this beryllium in an
standard and who has not received an emergency. It also would
examination since exposure to beryllium have amended paragraph
during the emergency must be provided an (k)(2)(i)(B) to focus
examination at the time the employee's only on the frequency of
employment terminates.. examinations for
(iv) For an employee who meets the criteria employees who show signs
of paragraph (k)(1)(i)(C) of this standard:. or symptoms of CBD or
(A) If that employee has not received a other beryllium-related
medical examination within the previous two health effects.
years pursuant to paragraph (k)(1)(i) of This final rule's
this standard, then within 30 days after the provisions differ from
employee meets the criteria of paragraph those in the proposal.
(k)(1)(i)(C) of this standard; or. Specifically, in this
(B) If that employee has received a medical final rule, OSHA removed
examination within the previous two years the requirement for a
pursuant to paragraph (k)(1)(i) of this medical examination
standard, then at least one year but no more within 30 days of
than two years after the employee meets the exposure in an emergency
criteria of paragraph (k)(1)(i)(C) of this and added paragraph
standard.. (k)(2)(iv). Final
paragraph (k)(2)(iv)(A)
requires the employer to
offer a medical
examination to an
employee within 30 days
after the employee was
exposed to beryllium in
an emergency, if the
employee has not had an
examination under
paragraph (k)(1)(i)
within the last two
years, while final
paragraph (k)(2)(iv)(B)
requires the employer to
offer a medical
examination to an
employee within one to
two years after the
employee was exposed to
beryllium in an
emergency, if the
employee had an
examination under
paragraph (k)(1)(i) of
the beryllium standard
within the last two
years. In addition, this
final rule revised
paragraph (k)(2)(iii) to
require that each
employee who is exposed
in an emergency and has
not received an
examination since the
emergency exposure must
be provided an
examination at the time
employment is
terminated.
As proposed in the 2018
NPRM, this final rule
also amended paragraph
(k)(2)(i)(B) to focus
only on the frequency of
examinations for
employees who show signs
or symptoms of CBD or
other beryllium-related
health effects.
Sec. 1910.1024(k)(7)--Medical Surveillance-- The 2018 NPRM would have
Referral to the CBD Diagnostic Center. amended paragraph (k)(7)
(7) CBD diagnostic center. (i) The employer of the 2017 standard to
must provide an evaluation at no cost to the require employers to
employee at a CBD diagnostic center that is provide, at no cost to
mutually agreed upon by the employer and the the employee and within
employee. The evaluation at the CBD a reasonable time after
diagnostic center must be scheduled within the initial consultation
30 days, and must occur within a reasonable with the CBD diagnostic
time, of:. center, any of the
(A) The employer's receipt of a physician's following tests if
written medical opinion to the employer that deemed appropriate by
recommends referral to a CBD diagnostic the examining physician
center; or. at the CBD diagnostic
(B) The employee presenting to the employer a center: Pulmonary
physician's written medical report function testing (as
indicating that the employee has been outlined by the American
confirmed positive or diagnosed with CBD, or Thoracic Society
recommending referral to a CBD diagnostic criteria),
center.. bronchoalveolar lavage
(ii) The employer must ensure that, as part (BAL), and
of the evaluation, the employee is offered transbronchial biopsy.
any tests deemed appropriate by the The proposal also
examining physician at the CBD diagnostic specified the timing of
center, such as pulmonary function testing the initial
(as outlined by the American Thoracic consultation.
Society criteria), bronchoalveolar lavage This final rule's
(BAL), and transbronchial biopsy. If any of provisions differ from
the tests deemed appropriate by the those in the proposal.
examining physician are not available at the Specifically, OSHA
CBD diagnostic center, they may be performed revised paragraph
at another location that is mutually agreed (k)(7)(i) to require
upon by the employer and the employee.. that the evaluation must
(iii) The employer must ensure that the be scheduled within 30
employee receives a written medical report days, and must occur
from the CBD diagnostic center that contains within a reasonable
all the information required in paragraph time, of the employer
(k)(5)(i), (ii), (iv), and (v) of this receiving one of the
standard and that the PLHCP explains the types of documentation
results of the examination to the employee listed in paragraph
within 30 days of the examination.. (k)(7)(i)(A) or (B).
(iv) The employer must obtain a written Previously, the general
medical opinion from the CBD diagnostic industry standard
center within 30 days of the medical required employers to
examination. The written medical opinion provide the examination
must contain only the information in within 30 days of the
paragraph (k)(6)(i), as applicable, unless employer receiving one
the employee provides written authorization of the types of
to release additional information. If the documentation listed in
employee provides written authorization, the paragraph (k)(7)(i)(A)
written opinion must also contain the or (B).
information from paragraphs (k)(6)(ii), This final rule also
(iv), and (v), if applicable.. added a provision, in
(v) The employer must ensure that each paragraph (k)(7)(ii),
employee receives a copy of the written which specifies that the
medical opinion from the CBD diagnostic employer must ensure
center described in paragraph (k)(7) of this that, as part of the
standard within 30 days of any medical evaluation, the employee
examination performed for that employee.. is offered any tests
(vi) After an employee has received the deemed appropriate by
initial clinical evaluation at a CBD the examining physician
diagnostic center described in paragraphs at the CBD diagnostic
(k)(7)(i) and (ii) of this standard, the center, such as
employee may choose to have any subsequent pulmonary function
medical examinations for which the employee testing (as outlined by
is eligible under paragraph (k) of this the American Thoracic
standard performed at a CBD diagnostic Society criteria),
center mutually agreed upon by the employer bronchoalveolar lavage
and the employee, and the employer must (BAL), and
provide such examinations at no cost to the transbronchial biopsy.
employee.. The new provision also
states that if any of
the tests deemed
appropriate by the
examining physician are
not available at the CBD
diagnostic center, they
may be performed at
another location that is
mutually agreed upon by
the employer and the
employee.
Sec. 1910.1024(n)(1)(i), (ii), & (iii)-- This final rule removed
Recordkeeping--Air Monitoring Data. the requirement for
(i) The employer must make and maintain a collection and recording
record of all exposure measurements taken to of Social Security
assess airborne exposure as prescribed in numbers from this
paragraph (d) of this standard.. provision. This change
(ii) This record must include at least the was adopted as proposed.
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 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).
Sec. 1910.1024(n)(3)(i), (ii), & (iii)-- This final rule removed
Recordkeeping--Medical Surveillance. the requirement for
(i) The employer must make and maintain a collection and recording
record for each employee covered by medical of Social Security
surveillance under paragraph (k) of this numbers from this
standard.. provision. This change
(ii) The record must include the following was adopted as proposed.
information about the employee:.
(A) Name 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).
Sec. 1910.1024(n)(4)(i) & (ii)-- This final rule removed
Recordkeeping--Training. the requirement for
(4) Training. (i) At the completion of any collection and recording
training required by this standard, the of Social Security
employer must prepare a record that numbers from this
indicates the name and job classification of provision. This change
each employee trained, the date the training was adopted as proposed.
was completed, and the topic of the
training..
(ii) This record must be maintained for three
years after the completion of training.
------------------------------------------------------------------------
VI. Federalism
OSHA reviewed this rule in accordance with the Executive Order on
Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999), which
requires that federal agencies, to the extent possible, refrain from
limiting state policy options, consult with states prior to taking any
actions that would restrict state policy options, and take such actions
only when clear constitutional and statutory authority exists and the
problem is national in scope. Executive Order 13132 provides for
preemption of state law only with the expressed consent of Congress.
Any such preemption is to be limited to the extent possible.
Under Section 18 of the OSH Act, Congress expressly provides that
states and U.S. territories may adopt, with federal approval, a plan
for the development and enforcement of occupational safety and health
standards. OSHA refers to such states and territories as ``State
Plans'' (29 U.S.C. 667). Occupational safety and health standards
developed by State Plans 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 Plans are free to
develop and enforce under state law their own requirements for safety
and health standards.
OSHA previously concluded from its analysis for the 2017 final rule
that promulgation of the beryllium standard complies with E.O. 13132
(82 FR at 2633). The amendments in this final rule do not change that
conclusion. 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 OSHA. In states with
OSHA-approved State Plans, this rulemaking does not significantly limit
state policy options.
VII. State Plans
When federal OSHA promulgates a new standard or more stringent
amendment to an existing standard, the states and U.S. Territories with
their own OSHA-approved occupational safety and health plans (State
Plans) must promulgate a state standard adopting such new federal
standard, or more stringent amendment to an existing federal standard,
or an at least as effective equivalent thereof, within six months of
promulgation of the new federal standard or more stringent amendment.
The state may demonstrate that a standard change is not necessary
because the state standard is already the same or at least as effective
as the federal standard change. Because a state may include standards
and standard provisions that are equally or more stringent than federal
standards, it would generally be unnecessary for a state to revoke a
standard when the comparable federal standard is revoked or made less
stringent. 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 state and local
government employees: Connecticut, Illinois, Maine, New Jersey, New
York, and the Virgin Islands.
As discussed in detail below in Section XI, Summary and Explanation
of the Final Rule, the majority of the changes made by this final rule
will clarify certain provisions and simplify or improve employer
compliance. After considering all of the changes made by this final
rule and the record as a whole, OSHA believes that this final rule
enhances employee safety, in part by revising provisions that may be
misinterpreted. Therefore, OSHA has determined that, within six months
of the rule's promulgation date, State Plans must review their state
standards and adopt amendments to those standards that are at least as
effective as the amendments to the beryllium general industry standard
finalized herein, as required by 29 CFR 1953.5(a), unless the State
Plans demonstrate that such amendments are not necessary because their
existing standards are already at least as effective at protecting
workers as this final rule. This decision is also informed by a comment
from Materion Brush, Inc. (Materion), in which Materion argued that
OSHA should require states to adopt the proposed changes (Document ID
0038-A5, p. 2).\9\ No other stakeholders opined on this issue.
---------------------------------------------------------------------------
\9\ OSHA notes that Materion also argued that the State Plans
that have already adopted the original OSHA standard should be
required to adopt the changes OSHA previously adopted in the 2018
direct final rule, as well as the changes that result from the
current rulemaking (Document ID 0038-A5, p. 1). Whether OSHA should
require State Plans to adopt the changes made in the 2018 direct
final rule is out of the scope of this rulemaking and, thus, will
not be considered here.
---------------------------------------------------------------------------
VIII. Unfunded Mandates Reform Act
OSHA reviewed this final rule according to the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) and Executive Order
13132 (64 FR 43255). As discussed above in Section IV, Final Economic
Analysis and Regulatory Flexibility Act Certification (FEA), of this
preamble, the agency determined that this final rule will not impose
significant additional costs on any private- or public-sector entity.
Further, OSHA previously concluded that the rule will not impose a
federal mandate on the private sector in excess of $100 million
(adjusted annually for inflation) in expenditures in any one year (82
FR at 2634). Accordingly, this final rule will not require significant
additional
expenditures by either public or private employers.
As noted above under Section VII, State Plans, the agency's
standards do not apply to state and local governments except in states
that have elected voluntarily to adopt a State Plan approved by the
agency. Consequently, this final rule does not meet the definition of a
``federal intergovernmental mandate'' (see Section 421(5) of the UMRA
(2 U.S.C. 658(5))). Therefore, for the purposes of the UMRA, the agency
certifies that this final rule will not mandate that state, local, or
tribal governments adopt new, unfunded regulatory obligations of, or
increase expenditures by the private sector by, more than $100 million
in any year.
IX. Consultation and Coordination With Indian Tribal Governments
OSHA has reviewed this final rule in accordance with Executive
Order 13175 (65 FR 67249) and determined that it does not have ``tribal
implications'' as defined in that order. This final rule does not have
substantial direct effects on one or more Indian tribes, 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.
X. Environmental Impacts
OSHA has reviewed this final rule in accordance with the
requirements of the National Environmental Policy Act of 1969 (NEPA)
(42 U.S.C. 4321 et seq.), the Council on Environmental Quality NEPA
regulations (40 CFR part 1500-1508), and the Department of Labor's NEPA
procedures (29 CFR part 11). As a result of this review, OSHA has
determined that this final rule will not have a significant impact on
air, water, or soil quality; plant or animal life; the use of land; or
aspects of the external environment.
XI. Summary and Explanation of the Final Rule
On December 11, 2018, OSHA published a Notice of Proposed
Rulemaking (83 FR 63746) (2018 NPRM) proposing changes to a number of
provisions in the general industry beryllium standard. Following
publication of the 2018 NPRM, a variety of stakeholders, including
representatives of industry, labor, medical groups, public health
organizations, federal and state government agencies, academia, trade
associations, and private citizens, submitted comments on OSHA's
proposed changes. After reviewing and carefully considering these
comments and the remainder of the record, OSHA has decided to adopt the
majority of the changes proposed, as well as additional changes that
were prompted by the comments received. These changes clarify certain
provisions and simplify or improve compliance for the other provisions
of the standard. OSHA believes that these changes will maintain safety
and health protections for workers and will further enhance worker
protections by ensuring that the standard is well understood and
implemented according to the agency's intent.
The following discussion summarizes the comments received on the
proposed changes to the general industry standard, lays out OSHA's
responses to and final determinations regarding the issues in the
comments, and explains each new or revised provision in this final rule
including details on any modification made from the proposal. As
discussed in detail below, the changes include the addition of one
definition and modifications to five existing definitions in paragraph
(b) and revisions to seven of the standard's other paragraphs,
including paragraph (f), Methods of compliance; paragraph (h), Personal
protective clothing and equipment; paragraph (i), Hygiene areas and
practices; paragraph (j), Housekeeping; paragraph (k), Medical
surveillance; paragraph (m), Communication of hazards; and paragraph
(n), Recordkeeping. The final rule also replaces the 2017 standard's
Appendix A with a new appendix designed to supplement the final
standard's definition of beryllium work area.
Definitions.
Paragraph (b) of the beryllium standard for general industry
provides definitions of key terms used in the standard. In this final
rule, OSHA is changing or adding six terms in the definitions paragraph
of the standard. The terms that OSHA is changing or adding are
beryllium sensitization, beryllium work area, CBD diagnostic center,
chronic beryllium disease, confirmed positive, and dermal contact with
beryllium.
Beryllium sensitization.
OSHA is adding the following definition for beryllium
sensitization: ``a response in the immune system of a specific
individual who has been exposed to beryllium. There are no associated
physical or clinical symptoms and no illness or disability with
beryllium sensitization alone, but the response that occurs through
beryllium sensitization can enable the immune system to recognize and
react to beryllium. While not every beryllium-sensitized person will
develop chronic beryllium disease (CBD), beryllium sensitization is
essential for development of CBD.'' The agency is adding this
definition to clarify other provisions in the standard, such as the
definitions of chronic beryllium disease (CBD) and confirmed positive,
as well as the provisions for medical surveillance in paragraph (k) and
hazard communication in paragraph (m).
This definition of beryllium sensitization is identical to the
definition proposed in the 2018 NPRM and is consistent with information
provided in the 2017 final beryllium rule (82 FR 2470). In the preamble
to the 2017 final rule, OSHA found that individuals sensitized through
either the dermal or inhalation exposure pathways respond to beryllium
through the formation of a beryllium-protein complex, which then binds
to T-cells stimulating a beryllium-specific immune response (82 FR at
2494). The formation of the T-cell-beryllium-protein complex that
results in beryllium sensitization rarely manifests in any outward
symptoms (such as coughing or wheezing); most who are sensitized show
no symptoms at all (see 82 FR at 2492, 2527). Once an individual has
been sensitized, any subsequent beryllium exposures via inhalation can
progress to serious lung disease through the formation of granulomas
and fibrosis (see 82 FR at 2491-98). Since the pathogenesis of CBD
involves a beryllium-specific, cell-mediated immune response, CBD
cannot occur in the absence of sensitization (82 FR at 2492; see also
NAS, 2008 (Document ID OSHA-H005C-2006-0870-1355)). Therefore, this
definition's explanation that beryllium sensitization is essential for
development of CBD is consistent with the agency's findings in the 2017
final rule.
Several commenters expressed support for OSHA's inclusion of a
definition of beryllium sensitization in the beryllium general industry
standard, including NJH (Document ID 0022, p. 2), the United
Steelworkers (USW) (Document ID 0033, p. 1), Materion (Document ID
0038, p. 8), the U.S. Department of Defense (DOD) (Document ID 0029, p.
1), and Edison Electric Institute (EEI) (Document ID 0031, p. 2).
According to the USW, the proposed definition is clear and accurate,
and is necessary because the beryllium standard includes many
provisions related to the recognition of and appropriate response to
beryllium sensitization among beryllium-exposed workers (Document ID
0033, p. 1).
Materion similarly commented that inclusion of the proposed definition
in the standard would improve workers' and employers' understanding of
this term (Document ID 0038, p. 4).
While OSHA received no objections to including a definition of
beryllium sensitization in the beryllium standard, several commenters
suggested changes to the proposed definition. The National Supplemental
Screening Program (NSSP) and NJH recommended that the definition of
beryllium sensitization should include the following text, based on the
ATS Statement on Beryllium: ``Beryllium sensitization is a response in
the immune system of an individual who has been exposed to beryllium. A
diagnosis of [beryllium sensitization] can be based on two abnormal
blood BeLPTs, one abnormal and one borderline blood BeLPT, three
borderline BeLPTs, or one abnormal bronchoalveolar lavage (BAL) BeLPT.
Beryllium sensitization is essential for development of CBD'' (Document
ID 0027 p. 1; 0022, p. 2; see also Document ID OSHA-H005C-2006-0870-
0364, pp. 1, 44). Neither organization, however, explained why this
definition of beryllium sensitization should be used instead of the
definition OSHA proposed.
OSHA disagrees with this recommendation. The agency is providing a
definition of beryllium sensitization to give stakeholders a general
understanding of what beryllium sensitization is and its relationship
to CBD. Information pertinent to medical identification of
sensitization is provided in the definition of confirmed positive,
which appears later in this section. OSHA has determined that the
agency's definitions of beryllium sensitization and confirmed positive
together provide the information suggested by NJH and the NSSP. The
definition of confirmed positive explains how the results of BeLPT
testing should be interpreted in the context of the standard's
provisions that refer to that term, such as evaluation at a CBD
diagnostic center and medical removal protection. The confirmed
positive definition establishes that these benefits should be extended
to workers who have a pattern of BeLPT results, obtained in a three-
year period, consistent with the NJH and the NSSP's recommended
definition of beryllium sensitization. The remainder of the information
suggested by NJH and the NSSP, which pertains to the relationship of
beryllium sensitization to beryllium exposure, the immune system, and
the development of CBD, is included in the definition of beryllium
sensitization that OSHA proposed and is including in this final
standard. For these reasons, OSHA has decided not to adopt the language
suggested by NJH and the NSSP.
The NSSP objected to the statement that no physical or clinical
symptoms, illness, or disability are associated with beryllium
sensitization alone, but did not explain the reason for their concern
with this statement (Document ID 0027, p. 1). Materion supported the
agency's inclusion of this information in the definition, stating that
``employees deserve to understand that beryllium sensitization does not
involve symptoms . . .'' (Document ID 0038, p. 5). The USW also
specifically supported the accuracy of this section of OSHA's proposed
definition of beryllium sensitization (Document ID 0033, p. 1).
The agency has decided to retain this statement in the definition
of beryllium sensitization because it is important that employers and
employees understand the asymptomatic nature of beryllium sensitization
and the need for specialized testing such as the BeLPT. The statement
is consistent with OSHA's discussion of beryllium sensitization in the
2017 final rule (82 FR at 2492-99). As OSHA discussed in the 2017 final
rule, sensitization through dermal contact has sometimes been
associated with skin granulomas, contact dermatitis, and skin
irritation, but these reactions are rare and those sensitized through
dermal exposure to beryllium typically do not exhibit any outward signs
or symptoms (see 82 FR at 2488, 2491-92, 2527). OSHA determined that
while beryllium sensitization rarely leads to any outward signs or
symptoms, beryllium sensitization is an adverse health effect because
it is a change to the immune system that leads to risk of developing
CBD (82 FR at 2498-99). The agency believes that the asymptomatic
nature of beryllium sensitization, especially in the lung, should be
conveyed to employers and employees to emphasize why specialized
testing such as the BeLPT should be provided to workers who may have no
symptoms of illness associated with beryllium exposure. For these
reasons, OSHA is retaining the statement ``[t]here are no associated
physical or clinical symptoms and no illness or disability with
beryllium sensitization alone'' in the definition of beryllium
sensitization.
The State of Washington Department of Labor and Industries,
Division of Occupational Safety and Health (DOSH), commented that
OSHA's proposed definition of beryllium sensitization places
unnecessary emphasis on the role that beryllium sensitization plays in
the development of CBD. According to DOSH, ``[t]his language may cause
confusion with proper diagnosis of CBD and application of the rule
requirements for workers who have developed CBD without a confirmed
beryllium sensitization'' (Document ID 0023, p. 1). Other commenters,
however, including NJH, the NSSP, and the USW, supported including the
statement that beryllium sensitization is necessary for the development
of CBD in OSHA's definition of beryllium sensitization (Document ID
0022, p. 2; 0027, p. 1; 0033, p. 1).
Following consideration of DOSH's comment, OSHA has determined that
this information should remain in the definition of beryllium
sensitization (as well as the definition of chronic beryllium disease,
discussed later). OSHA believes that an understanding of the
relationship between beryllium sensitization and CBD is key to workers'
and employers' understanding of the beryllium standard. By including
the role that sensitization plays in the development of CBD in the
definition of beryllium sensitization, OSHA intends to make a number of
things clear to workers and employers: That beryllium sensitization,
although not itself a disease, is nevertheless an adverse health effect
that presents a risk for developing CBD and thus should be prevented;
the need to identify beryllium sensitization through regular medical
screening; and why workers who are confirmed positive should be offered
specialized medical evaluation and medical removal protection. OSHA
notes that DOSH does not dispute the factual accuracy of OSHA's
statement regarding the role beryllium sensitization plays in the
development of CBD, which the agency established in the Health Effects
section of the 2017 final rule (82 FR at 2495-96).
Nevertheless, OSHA agrees with DOSH that it is not always necessary
to identify a worker as beryllium sensitized by the BeLPT as part of a
diagnosis of CBD, and the agency acknowledges that some sensitized
individuals may not be confirmed positive for beryllium sensitization
by BeLPT testing. OSHA established in the Health Effects section of the
preamble to the 2017 final rule that while BeLPT testing is helpful to
identify workers at risk for CBD and to differentiate CBD from
respiratory diseases with similar clinical presentation, CBD can be
diagnosed in the absence of a confirmed positive BeLPT (see 82 FR at
2499-5002) (discussing a number of studies conducted prior to the
development of the BeLPT). At least one study in the rulemaking record
found that some
beryllium workers who would not have been confirmed positive by their
BeLPT results were found to be sensitized via the BAL BeLPT and went on
to develop CBD (Newman et al., 2001, Document ID OSHA-H005C-2006-0870-
1354, p. 234). Other studies indicate that the BeLPT has a false-
negative rate of approximately 25-28 percent (that is, approximately
25-28 percent of individuals who have a single normal BeLPT result are
in fact sensitized) (Middleton et al., 2011, Document ID OSHA-H005C-
2006-0870-0399, p. 2 (25 percent); Stange et al., 2004, Document ID
OSHA-H005C-2006-0870-1402, p. 457 (27.7 percent)). Because the BeLPT
itself may have a false-negative result and because other means exist
to diagnose CBD apart from the BeLPT, examining physicians should have
the latitude to diagnose CBD in the absence of a ``confirmed positive''
pattern of BeLPT results. Moreover, as discussed below, the
determination that an employee is ``confirmed positive'' under the
beryllium standard acts only as a trigger for medical monitoring and
surveillance and OSHA does not intend the phrase ``confirmed positive''
to be interchangeable with ``beryllium sensitized.''
The standard provides a mechanism for an employee to be referred to
a CBD diagnostic center and diagnosed with CBD, even in the absence of
a confirmed positive blood BeLPT result. Under paragraph (k)(5)(iii),
the licensed physician can recommend referral to a CBD diagnostic
center if he or she deems it appropriate. As OSHA explained in the
preamble to the 2017 final rule, the licensed physician could recommend
an evaluation at a CBD diagnostic center based on questionable BeLPT
findings (82 FR at 2714). For example, in a scenario where an employee
has repeating borderline or abnormal results but does not meet the
definition for confirmed positive, referral to a CBD diagnostic center
may be appropriate.
Furthermore, the standard does not specify how CBD is diagnosed and
gives the licensed physician at the CBD diagnostic center discretion
for making that diagnosis, including by means other than blood BeLPT
results. The diagnostic criteria for CBD include (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 (82 FR at 2500; see also Newman et
al., 1989 (Document ID OSHA-H005C-2006-0870-0196, p. 1480)). The
availability of transbronchial lung biopsy facilitates the evaluation
of the second criterion, by making histopathological confirmation
possible in almost all cases (82 FR at 2500). The ATS has noted that
the BAL BeLPT can be useful in diagnosing CBD in individuals who have
normal blood BeLPT results and considers one positive BAL BeLPT
sufficient for the diagnosis of beryllium sensitization (Document ID
OSHA-H005C-2006-0870-0364, pp. 44-45). OSHA expects that the licensed
physician might apply such criteria in the diagnosis of CBD, without
relying on a confirmed positive finding based on blood BeLPT results.
In summary, OSHA believes that emphasizing the role that beryllium
sensitization plays in the development of CBD provides employers and
employees with important context for understanding the beryllium
standard. At the same time, the agency acknowledges that employees may
be diagnosed with CBD in the absence of a confirmed positive BeLPT, and
the beryllium standard allows for such a diagnosis. Thus, following
consideration of the record of comments on OSHA's proposed definition
of beryllium sensitization, the agency is finalizing the definition as
proposed in the 2018 NPRM. The addition of this definition for
beryllium sensitization does not change employer obligations under
paragraphs (k) and (m) and, therefore, OSHA expects that the new
definition will maintain safety and health protections for workers.
Beryllium work area.
Paragraph (b) of the final rule defines beryllium work area as any
work area where materials that contain at least 0.1 percent beryllium
by weight are processed either: (1) During any of the operations listed
in Appendix A of the standard; or (2) where employees are, or can
reasonably be expected to be, exposed to airborne beryllium at or above
the action level. The presence of a beryllium work area triggers a
number of requirements in the standard. These include the requirements
under paragraphs (e)(1)(i) and (2)(i) to establish, maintain, and
demarcate the boundaries of each beryllium work area, as well as
requirements under paragraphs (f)(1)(i)(D) and (F), written exposure
control plan requirements; paragraph (f)(2)(ii), required exposure
controls; paragraphs (i)(1) and (2), general hygiene practices and
change rooms requirements; paragraphs (j)(1)(i) and (2), housekeeping
requirements; and paragraph (m)(4)(ii)(B), employee training. The
establishment of beryllium work areas serves to ensure that employees
and other persons are aware of the potential presence of airborne
beryllium; to control access to these areas; and in conjunction with
other provisions such as the written control plan, hygiene, and
housekeeping requirements, to minimize the transfer of beryllium to
other areas of the facility and reduce the potential for exposure to
other employees.
The term beryllium work area (as revised in the 2018 direct final
rule) was defined as any work area (1) containing a process or
operation that can release beryllium and that involves material that
contains at least 0.1 percent beryllium by weight; and, (2) 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. That definition was developed in response to
stakeholder comments on the 2015 NPRM, which had proposed to define a
beryllium work area as any work area where there is potential for
exposure to airborne beryllium at any level, and which did not include
dermal contact as a trigger for establishment of a beryllium work area.
Some stakeholders argued that the definition proposed in the 2015 NPRM
was overly broad and could be interpreted as applying to most or all
areas of a worksite, regardless of the work processes or operations
occurring in those areas. Commenters also expressed concern that the
definition was vague and should be triggered on a measurable threshold
of exposure. NIOSH commented that the proposed definition's focus on
airborne beryllium did not account for the potential contribution of
dermal exposures to total exposure (82 FR at 2659).
In response to these comments, OSHA modified the definition in the
2017 final rule to require the presence of a beryllium-releasing
process. The agency explained in the preamble that triggering the
requirement of creating a beryllium work area on a specific threshold
level of exposure would be insufficiently protective of workers, but
also explained that the agency did not intend for a beryllium work area
to be established in areas where work processes or operations that
release beryllium do not occur, such as where employees handle articles
containing beryllium (82 FR at 2659-60). Rather, the purpose of
establishing beryllium work areas is to identify and demarcate areas
within a facility where processes or operations release beryllium so
that necessary control measures can be implemented, such as those
designed to prevent the migration of beryllium to other areas where
beryllium is not processed or released. OSHA clarified this intent by
defining a beryllium work
area as an area that contains processes or operations that release
beryllium to which workers could be exposed. Additionally, OSHA
accounted for NIOSH's concern by including the potential for dermal
contact with beryllium in the definition (see 82 FR at 2658-60).
In the preamble to the 2017 final rule, however, OSHA disagreed
with commenters who claimed that the proposed definition of beryllium
work area was impermissibly vague. The agency explained that, by
limiting the trigger for beryllium work areas to exposures generated
from a beryllium-releasing process or operation within the area, the
definition made clear that the requirements were not triggered solely
on the fact that an employee may be handling solid material containing
beryllium. Additionally, any employer who had doubts about whether a
process was releasing beryllium or created the potential for dermal
contact with beryllium could use air sampling or wipe sampling to
determine where the boundary of a beryllium work area should be
established. OSHA reasoned that, rather than rendering the provision
vague, defining a beryllium work area in a performance-based manner
left employers flexibility in complying with the standard (82 FR at
2659).
Nevertheless, following publication of the 2017 standard, OSHA
continued to hear from stakeholders that the definition of beryllium
work area remained a source of substantial uncertainty and confusion.
Some stakeholders expressed concern that defining a beryllium work area
to include any area where unspecified processes can reasonably be
expected to generate any level of airborne beryllium, or where there is
a process or operation that can release beryllium or the potential for
dermal contact with beryllium, could lead to the designation of entire
facilities as beryllium work areas because minute quantities of
beryllium can sometimes be detected in areas of a facility far distant
from the work processes that create beryllium exposures. Stakeholders
requested that OSHA provide a list of operations that are known to
release airborne beryllium, which would allow employers to more
accurately identify where beryllium work areas must be established and
demarcated at their workplaces. As described in more detail below,
stakeholders also requested that ``dermal contact'' be removed from the
definition of beryllium work area.
In response to this feedback, OSHA proposed in this rulemaking to
modify the definition of beryllium work area to provide clarity for
employers on where and when to establish a beryllium work area. First,
OSHA proposed a new appendix to the standard (Appendix A), containing
Table A.1, which includes a list of operations that are commonly
performed when processing beryllium materials and are known to generate
airborne beryllium. OSHA proposed to revise the definition of beryllium
work area so that any work area where an operation that is listed in
proposed Appendix A occurs, and involves materials containing at least
0.1 percent beryllium by weight, is a beryllium work area. For work
areas where no operations listed in proposed Appendix A occur, the
proposed definition would require a beryllium work area wherever
materials containing at least 0.1 percent beryllium by weight are
processed and where employees are, or can be reasonably expected to be,
exposed to airborne beryllium at or above the action level. The list of
operations in Table A.1 was compiled based on the experience of
Materion, the primary beryllium manufacturer in the United States, and
the USW, the primary union representing employees with beryllium
exposure.\10\ As noted in the preamble to the 2018 NPRM, OSHA intends
the list to cover all operations and processes that have the potential
for exposure to airborne beryllium (83 FR at 63761).
---------------------------------------------------------------------------
\10\ Table A.1 is divided into three categories: (1) Beryllium
Metal Alloy Operations (generally <10% beryllium by weight); (2)
Beryllium Composite Operations (generally >10% beryllium by weight)
and Beryllium Metal Operations; and (3) Beryllium Oxide Operations.
---------------------------------------------------------------------------
Second, OSHA proposed to remove the reference to dermal contact
from the definition of the term beryllium work area. OSHA preliminarily
determined that this change would make it less likely that the
definition could be misinterpreted as extending to areas of a facility
where work processes or operations that release beryllium do not occur
or even to entire facilities (83 FR at 63749). Further, the agency
explained that it was unaware of beryllium-releasing processes or
operations that have a potential for dermal contact that are not
included in the proposed Appendix A or do not generate airborne
exposures at or above the action level (83 FR at 63749). Therefore,
OSHA preliminarily determined that the proposed change would be as
protective as the previous definition, while more clearly avoiding the
erroneous perception that the standard would require employers to treat
entire facilities as beryllium work areas.
Comments submitted in response to the NPRM showed general support
from employers, unions, and public health experts for OSHA's proposed
approach and for providing better clarity with respect to beryllium
work areas (Document ID 0017; 0022, pp. 6-7; 0029, p. 1; 0033, pp. 1-4;
0038, pp. 8-9). For example, the USW agreed with OSHA that the
revisions proposed in the NPRM would make the definition more precise
and help to ensure that employers can appropriately comply with the
standard. The USW stated that the proposed definition ``provides
employers with a clearer means of understanding when and where
demarcation is required'' for beryllium work areas (Document ID 0033,
p. 2). Materion likewise indicated that this new approach ``greatly
improves and simplifies an understanding of where beryllium work areas
should be in a facility, allowing employers and employees to know and
understand how to comply with the requirement to establish these
protective work areas'' (Document ID 0038, p. 9).
While there was general support for this proposed approach to
beryllium work areas, several commenters expressed concerns about
various aspects of the new definition and new Appendix A. For example,
DOSH agreed that the addition of a new Appendix A would provide clarity
to the beryllium work area requirements but expressed concern that
removal of the dermal contact trigger would reduce worker protections.
DOSH suggested the use of a defined lower limit for beryllium
contamination on surfaces that would address this concern while
maintaining the protection for workers (Document ID 0023, pp. 1-2).
OSHA does not agree that removing the reference to dermal contact
from the definition of the term beryllium work area reduces
protections. As noted above and explained in both the preambles to the
2017 final rule and the 2018 NPRM, OSHA's intent was to capture those
areas of a facility where beryllium-generating processes or operations
are located; OSHA never intended for dermal contact alone to trigger
the standard's beryllium work area requirements (82 FR at 2659; 83 FR
at 63748). Contrary to DOSH's assertion, the requirement to establish a
beryllium work area was dependent on the presence of a process or
operation that can release beryllium and that involves material that
contains at least 0.1 percent beryllium by weight in the area in
question; exposure alone, whether airborne or dermal, was never a
trigger for the beryllium work area requirements.
Moreover, again as noted above, OSHA explained in the 2018 NPRM
that it did not know of any beryllium-releasing processes or operations
with
the potential for dermal contact that are not included in the proposed
Appendix A or that do not generate airborne exposures at or above the
action level. Put more simply, OSHA was unaware of any situation where
an employer would be required to establish a beryllium work area under
the previous definition but would not be required to do so under the
proposed definition. However, in the interest of caution, OSHA asked
stakeholders specifically whether there are any operations or processes
that trigger beryllium work areas under the previous definition that
would not be covered under the proposed definition (83 FR at 63749).
Commenters did not point to any such processes. On the contrary, the
only stakeholder to squarely address this issue, Materion, noted that
it too was ``unaware of work areas containing beryllium-releasing
processes or operations that have a potential for dermal contact that
are not included in the proposed Appendix A or generate airborne
exposures at or above the action level'' (Document ID 0038 p. 13).
Furthermore, another stakeholder, the USW commented that it
supported OSHA's proposed removal of the reference to dermal contact
from the definition of the term beryllium work area (Document ID 0033,
p. 3). The USW stated that it does not have reservations about the
proposed change and explained its belief ``that dermal exposure is
properly addressed elsewhere in the standard'' (Document ID 0033, pp.
1-3). According to the USW, ``[a]lthough dermal exposure to beryllium
is important and must be properly addressed, removal of dermal exposure
from this definition will reduce the confounding factors that might
result in unnecessarily extending beryllium work areas beyond needed
portions of a workplace'' (Document ID 0033, p. 3).
In addition, DOSH did not explain why it believes the change would
reduce worker protections. Given that DOSH did not point to any
particular loss of worker protection and the lack of evidence of any
differences between the coverage of the two definitions, OSHA has
decided to adopt the proposed definition, which commenters have
indicated reduces the confusion caused by the previous definition. OSHA
expects the revised definition to provide clarity on the proper
boundaries of a beryllium work area. Employers are required by
paragraph (j)(1), in conjunction with paragraph (f)(1), to minimize the
migration of beryllium from beryllium work areas, and clearly defining
the beryllium work area ensures employees working outside of these
areas receive the protective benefits of these requirements. If a
beryllium work area is defined overly broadly, then more employees may
inadvertently be exposed to beryllium within the beryllium work area
and would not receive some of these benefits. Moreover, as stated in
the 2018 NPRM, PPE requirements to protect against dermal exposure to
beryllium do not depend on the existence of a beryllium work area. The
standard requires employers to provide and ensure the use of
appropriate PPE whenever there is a reasonable expectation of dermal
contact with beryllium, regardless of whether or not the area is a
beryllium work area (see 83 FR at 63749).
OSHA also does not agree with DOSH that a lower limit for beryllium
contamination on surfaces is necessary as a trigger for establishing a
beryllium work area. In the 2017 final rule, OSHA chose not to set
quantitative limits for surface contamination because the best
available scientific evidence on adverse health effects from dermal
contact with beryllium made it difficult to identify an appropriate
limit for surface contamination (82 FR at 2688). This remains the case
today. OSHA discusses the limitations of this data more fully below in
the Summary and Explanation of the definition of dermal contact with
beryllium.
Two commenters objected to the exemption for materials that contain
less than 0.1 percent beryllium from the definition of beryllium work
area (Document ID 0022, p. 7; 0027, p. 2). However, OSHA incorporated
this change in the 2018 direct final rule. At the time, OSHA explained
that it was never the agency's intent that the requirements related to
beryllium work areas apply to these materials (83 FR 19936, 19938 (May
7, 2018)). OSHA did not receive any adverse comments on the direct
final rule and therefore finalized the change. The 2018 NPRM did not
propose to amend this portion of the definition and therefore comments
related to the 0.1 percent limitation are not within the scope of this
rulemaking.
OSHA also received comments on the new Appendix A. NJH expressed
concerns that the proposed list of operations in Appendix A was geared
toward manufacturing and that it ``may restrict employers'
interpretations of a beryllium work area and prevent employees from the
protections afforded by the beryllium standard. Employers may only
consider these featured tasks as those that dictate a beryllium work
area, when other tasks may be considered as such'' (Document ID 0022,
pp. 6-7). OSHA believes NJH's concern is misplaced. First, OSHA
requested comment on whether there were additional operations that
should be included on the list of operations in Appendix A, and no
suggestions for additional operations were put forth by commenters.
More importantly, the final standard requires that a beryllium work
area be established if exposures can reasonably be expected to exceed
the action level where materials that contain at least 0.1 percent
beryllium by weight are processed, regardless of whether the operation
is listed in Appendix A. As the USW noted, this requirement ``provides
a backstop for any unforeseen operation which can expose employees
above the action level'' (Document ID 0033, p. 2). Thus, employees who
may be exposed above the action level during a process not listed in
Appendix A will still receive the protections afforded by the beryllium
work area requirements.
DOD, while generally supportive of the proposed definition of
beryllium work area, expressed some concerns about Appendix A (Document
ID 0029, p. 1). First, DOD suggested, without explanation, that OSHA
remove the word ``generally'' from the description of the table in
Appendix A, which describes beryllium metal alloy operations as being
``generally < 10% beryllium by weight'' and beryllium composite
operations as being ``generally > 10% beryllium by weight.'' OSHA
disagrees with this suggestion. The table in Appendix A reflects
materials that are on the market today. However, the inclusion of the
word ``generally'' accounts for the possibility of beryllium metal
alloy operations and beryllium composite operations involving different
materials. Thus, if alloys are developed with greater than 10 percent
beryllium or composites less than 10 percent beryllium, these materials
will be covered under Table A.1. Because OSHA does not intend to limit
Table A.1 to processes involving only those materials on the market
today, the agency is retaining the word ``generally'' in the
description of the tables in Appendix A.\11\
---------------------------------------------------------------------------
\11\ The agency notes that DOD's comment suggests there might be
some confusion as to whether beryllium alloys and beryllium
composites are analogous. In fact, these materials have different
structures and should be treated differently from a control strategy
point of view. A metal alloy is a metal which is a homogeneous
mixture of two or more metals or of a metal and another element to
provide unique characteristics or properties (see https://www.thefreedictionary.com/Metal+alloy). A ``beryllium composite,''
on the other hand, is a metal matrix composite or (MMC) which
typically contain at least two distinct constituent parts (see
https://www.azom.com/article.aspx?ArticleID=9843).
---------------------------------------------------------------------------
DOD, along with DOSH, also questioned the deletion of the Appendix
A published with the 2017 final beryllium rule. That old appendix
provided non-mandatory general control strategies for common
operations. These commenters thought that the old appendix was useful
and should be retained in the standard (Document ID 0029, p. 1; 0023,
p. 3). OSHA agrees that the old appendix contained useful information,
but expects that in time it would have become either obsolete or
incomplete. Instead, OSHA plans to provide this information about
general control strategies in guidance materials tailored to reach the
targeted audience. This will make it easier to update as new
technologies or beryllium processes become available.
In addition, under paragraph (f)(2), Engineering and work
practices, employers are obligated to use engineering controls in
beryllium work areas. OSHA requires employers to use at least one type
of control that is listed in paragraph (f)(2)(ii) (substitution,
isolation, local exhaust ventilation, or process controls) unless
controls are infeasible or exposures are demonstrated to be below the
action level. These general controls are the same types of controls
that were listed in Appendix A and are required regardless of whether
that appendix is retained. For these reasons, this final standard does
not retain the old Appendix A.
Materion fully supported the proposed changes to the beryllium work
area definition and the proposed Appendix A. However, it noted a
typographical error in Appendix A for ``High Speed Machining (<= 10,000
rpm),'' which should be (> 10,000 rpm) (Document ID 0038, p. 10). OSHA
agrees that the entry in the NPRM's Appendix A is incorrect and made
the appropriate correction in this final rule.
After careful consideration of the record, OSHA has determined that
the revised definition of beryllium work area will improve compliance
with the standard by providing greater clarity to employers regarding
when and where beryllium work areas should be established in the
workplace. The agency further finds that properly identifying beryllium
work areas will reduce potential exposure for workers outside of these
areas through the various provisions triggered by beryllium work areas.
In sum, OSHA has determined that the revision to the definition of
beryllium work area will ensure that the standard's requirements
related to beryllium work areas are workable and properly understood.
Therefore, OSHA has decided to finalize the definition of beryllium
work area and the corresponding update to Appendix A as proposed, with
the exception of correcting the typographical error in Appendix A noted
by Materion.
CBD diagnostic center.
OSHA is amending the 2017 final rule's definition of CBD diagnostic
center to clarify certain requirements used to qualify an existing
medical facility as a CBD diagnostic center. The clarification does not
change the requirement for the employer to offer a follow-up
examination at a CBD diagnostic center to employees meeting the
criteria set forth in paragraph (k). OSHA is defining CBD diagnostic
center to mean a medical diagnostic center that has a pulmonologist or
pulmonary specialist on staff and on-site facilities to perform a
clinical evaluation for the presence of CBD. The revised definition
also states that a CBD diagnostic center must have the capacity to
perform pulmonary function testing (as outlined by the American
Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy. In the revised definition, the CBD diagnostic
center must also have the capacity to transfer BAL samples to a
laboratory for appropriate diagnostic testing within 24 hours and the
pulmonologist or pulmonary specialist must be able to interpret the
biopsy pathology and the BAL diagnostic test results. This definition
is identical to the definition of CBD diagnostic center that OSHA
proposed in the 2018 NPRM.
The revised definition of CBD diagnostic center differs from the
former definition in a number of ways. First, whereas the 2017 final
rule's definition specified only that a CBD diagnostic center must have
a pulmonary specialist, OSHA is adding the term ``pulmonologist'' to
clarify that either type of specialist is qualified to perform a
clinical evaluation for the presence of CBD. Additionally, the 2017
definition required that a CBD diagnostic center have an on-site
pulmonary specialist. The revised definition states that the CBD
diagnostic center must simply have a pulmonologist or pulmonary
specialist on staff. This clarifies OSHA's intent that a specialist
must be available to the CBD diagnostic center but need not necessarily
be on site at all times.
In their comments on the 2018 NPRM, two commenters, NJH and the
ATS, recommended that a pulmonologist, occupational medicine
specialist, or physician with expertise in beryllium disease should
conduct the clinical evaluation for CBD and that a pulmonologist should
be on staff or available to perform the bronchoscopy (Document ID 0022,
p. 2; 0021, p. 2). According to NJH, clinics that regularly evaluate
patients for CBD have physicians with experience in occupational health
conduct the clinical evaluation for CBD, in conjunction with a
pulmonologist who performs a bronchoscopy (Document ID 0022, pp. 2-3).
OSHA notes that, although the agency is requiring facilities to
have a pulmonologist or pulmonary specialist on staff who is able to
interpret the biopsy pathology and the BAL diagnostic test results,
OSHA does not intend that all aspects of clinical evaluation for CBD
must be performed by a pulmonologist or pulmonary specialist. In the
preamble to the 2017 final rule, OSHA explained that the agency was
defining a CBD diagnostic center as a facility with a pulmonary
specialist ``on-site'' specifically to indicate that the specialist
need not personally perform the BeLPT testing (82 FR at 2645).
Moreover, paragraph (k)(7), which sets out the substantive requirements
for the evaluation at the CBD diagnostic center, refers to
recommendations of the ``examining physician,'' not necessarily the
pulmonologist or pulmonary specialist.
Paragraph (b), in turn, defines physician or other licensed health
care professional (PLHCP) as an individual licensed to provide some or
all of the services required by paragraph (k). As such, some parts of
the evaluation, such as lung function tests, might be performed by a
certified medical professional other than a pulmonologist or pulmonary
specialist. The arrangement that NJH describes as typical for clinics
treating CBD patients, in which physicians with experience in
occupational health conduct the clinical evaluation for CBD in
conjunction with a pulmonologist who performs a bronchoscopy, is
consistent with OSHA's intent for the definition of CBD diagnostic
center and other provisions of the standard related to CBD diagnosis.
Therefore, OSHA has determined that it is not necessary to revise the
definition of CBD diagnostic center to require that the clinical
evaluation for CBD be conducted by a pulmonologist, occupational
medicine specialist, or physician with expertise in beryllium disease.
An additional change to the definition of CBD diagnostic center
clarifies that the diagnostic center must have the capacity to perform
pulmonary function testing (according to American Thoracic Society
criteria), bronchoalveolar lavage (BAL), and tranbronchial biopsy. OSHA
determined that the former definition--which stated that the evaluation
at the
diagnostic center ``must include'' these tests--could have been
misinterpreted to mean that the examining physician was required to
perform each of these tests during every clinical evaluation at a CBD
diagnostic center. The agency's intent is not to dictate which tests an
evaluation at a CBD diagnostic center should include, but to ensure
that any CBD diagnostic center has the capacity to perform any of these
tests, which are commonly needed to diagnose CBD. OSHA expects that
these are the tests that would most commonly be requested for a CBD
evaluation. Therefore, the agency is revising the definition to clarify
that the CBD diagnostic center must simply have the ability to perform
each of these tests when deemed appropriate. These changes clarify the
definition of CBD diagnostic center, and OSHA expects they will
maintain safety and health protections for workers.
Materion submitted comments supporting OSHA's intent to specify the
required capacities of a CBD diagnostic center, rather than the
contents of a CBD evaluation, in the definition of CBD diagnostic
center (Document ID 0038, pp. 16-17). NJH expressed concern that this
change to the definition may indicate that the clinical evaluation for
CBD need not include certain aspects of a CBD evaluation, which NJH,
the Association of Occupational and Environmental Clinics (AOEC), and
the ATS recommend should typically include full pulmonary function
testing (lung volumes, spirometry, and diffusion capacity for carbon
monoxide), chest imaging, and cardiopulmonary exercise testing, and may
also include bronchoscopy in some cases (Document ID 0022, p. 3; 0028,
p. 2; 0021, pp. 1-2). Similarly, the ATS commented that not requiring
certain diagnostic tests ``could reduce the potential to diagnose CBD
and determine disease severity'' (Document ID 0021, p. 3). NJH
recommended that OSHA require the ATS recommendations for diagnostic
evaluation, which the NJH stated include the BeLPT; pulmonary function
testing and chest imaging; and in some cases bronchoscopy (Document ID
0022, p. 3).
As explained below in the Summary and Explanation of paragraph
(k)(7), that provision--which establishes the substantive requirements
for the evaluation at the CBD diagnostic center--makes clear that the
employer must offer any tests that the examining physician at the CBD
diagnostic center deems appropriate. The definition of CBD diagnostic
center in paragraph (b) does not alter this requirement. In light of
paragraph (k), the revised definition of CBD diagnostic center cannot
reasonably be read to limit the types of tests available to the
employee (see the Summary and Explanation for paragraph (k)(7) for a
full discussion of this topic). Thus, after considering these comments,
OSHA has decided to retain the proposed change to the definition of CBD
diagnostic center.
Chronic beryllium disease (CBD).
OSHA is also amending the definition of chronic beryllium disease.
For the purposes of this standard, the agency is using the term chronic
beryllium disease to mean a chronic granulomatous lung disease caused
by inhalation of airborne beryllium by an individual who is beryllium
sensitized. OSHA is finalizing the definition as proposed. It includes
several changes to the 2017 final rule's definition of chronic
beryllium disease, which was ``a chronic lung disease associated with
exposure to airborne beryllium'' (82 FR at 2645-46). The revisions
serve to differentiate CBD from other respiratory diseases associated
with beryllium exposure (e.g., lung cancer) and to make clear that
beryllium sensitization and the presence of beryllium in the lung are
essential in the development of CBD (see 82 FR at 2492).
First, OSHA is adding the term ``granulomatous'' to the definition.
A granulomatous lung formation is a focal collection of inflammatory
cells (e.g., T-cells) creating a nodule in the lung (see Ohshimo et
al., 2017, Document ID OSHA-H005C-2006-0870-2171, p. 2). The formation
of the type of lung granuloma specific to a beryllium immune response
can occur only in those with CBD (82 FR at 2492-2502). Next, OSHA is
removing the phrase ``associated with airborne exposure to beryllium''
and replacing it with ``caused by inhalation of airborne beryllium.''
This change is more consistent with the findings in the 2017 final rule
that beryllium is the causative agent for CBD and that CBD occurs only
after inhalation of beryllium (82 FR at 2513). Finally, OSHA is
clarifying that CBD is caused by inhalation of airborne beryllium ``by
an individual who is beryllium sensitized.'' Along with the revised
definition of beryllium sensitization discussed above, this revision
emphasizes to employers and employees the role that beryllium
sensitization plays in the development of CBD.
NJH, the USW, and Materion agreed with OSHA that the 2017 final
standard's definition of chronic beryllium disease should be clarified.
Materion supported the changes OSHA proposed, which it characterized as
a necessary clarification to ensure the definition provided is specific
to chronic beryllium disease (Document ID 0038, p. 17). The USW
similarly supported the proposed definition, stating that it clarifies
the previous definition which ``could be read to apply to any chronic
lung disease caused by beryllium, including lung cancer'' (Document ID
0033, p. 5). These comments reinforce OSHA's determination that adding
the term ``granulomatous'' to the definition will better distinguish
CBD from other occupationally associated chronic pulmonary diseases. As
OSHA explained in the preamble to the 2017 final rule, the formation of
the type of lung granuloma specific to a beryllium immune response can
occur only in those with CBD (82 FR at 2492-2502).
Several commenters expressed concern that the proposed definition
of chronic beryllium disease does not provide sufficient information to
guide diagnosis of CBD, and specifically that OSHA's emphasis on the
role of sensitization in the development of CBD may confuse diagnostic
efforts. The ATS noted that demonstrating beryllium sensitization may
be challenging in certain settings and recommended that OSHA's
definition of chronic beryllium disease use the diagnostic criteria for
CBD outlined in a 2014 ATS document on diagnosis and management of
beryllium sensitivity and CBD (``the ATS Statement''). These diagnostic
criteria include confirmation of an immune response to beryllium and
granulomatous lung inflammation using lung biopsy and emphasize the
various approaches which may be used ``[d]epending on the clinical
setting, feasibility of certain diagnostic tests, and degree of
diagnostic certainty needed'' (Document ID 0021, p. 5). DOSH similarly
emphasized that individuals may be diagnosed with CBD without a
confirmed positive BeLPT result and advocated that the definition of
chronic beryllium disease ``ensure employers and medical providers are
given a clear expectation of how beryllium conditions are properly
identified'' (Document ID 0023, p. 2).
OSHA notes that the standard's definition of chronic beryllium
disease is not intended to provide criteria for the diagnosis of CBD.
The agency's intent is to provide readers who may have little or no
familiarity with CBD with a general understanding of the term, rather
than to provide diagnostic criteria for healthcare professionals in
addressing CBD.
Due to differences in individual cases and circumstances, medical
specialists may need to apply somewhat different
testing regimens and/or diagnostic criteria to different individuals
they evaluate for CBD. Furthermore, the diagnostic tools and criteria
available to medical specialists may change over time. As discussed in
the Summary and Explanation for paragraph (k)(7), OSHA believes that
the physician at the CBD diagnostic center should have the latitude to
use any tests he or she deems appropriate for the purpose of diagnosing
or otherwise evaluating CBD in a patient, and has revised paragraph
(k)(7) to make this clear. Therefore, OSHA has determined that it is
neither necessary nor appropriate to specify diagnostic criteria in the
beryllium standard's definition of chronic beryllium disease. Instead,
OSHA has decided to retain a definition that provides the reader with a
general understanding of the term.
NJH suggested that the agency define chronic beryllium disease as a
disease ``characterized by evidence of granulomatous lung inflammation
in an individual who is sensitized to beryllium.'' According to NJH,
this definition would allow for diagnosis based on different
combinations of clinical evaluation results as detailed the ATS
Statement (Document ID 0022, p. 3). OSHA believes that the definition
the agency proposed--a chronic granulomatous lung disease caused by
inhalation of airborne beryllium by an individual who is beryllium
sensitized--conveys the substance of NJH's recommended definition while
also emphasizing that CBD results from the inhalation of airborne
beryllium. OSHA has therefore decided not to adopt the definition NJH
suggested.
The ATS expressed concern that OSHA's proposed changes to the
definition of chronic beryllium disease could create confusion in the
diagnosis of CBD because it may be challenging in certain settings to
identify sensitization and granulomatous lung disease based on lung
pathology (Document ID 0021, p. 5). DOSH similarly commented that the
proposed definition may be misleading because, although those with CBD
have sensitization to beryllium, the current testing for sensitization
has a high false-negative rate and individuals may be diagnosed with
CBD without first being confirmed positive for beryllium sensitization
(Document ID 0023, p. 2).
Although OSHA agrees that employees may be diagnosed with CBD
without confirmed positive BeLPT results, the agency does not agree
with these commenters that references to sensitization should be
excluded from the definition of chronic beryllium disease. OSHA first
notes that neither DOSH nor the ATS contend that OSHA's definition is
inaccurate. Furthermore, as OSHA explained previously in its discussion
of the beryllium sensitization definition, the agency believes that a
correct understanding of the relationship between beryllium
sensitization and CBD is key to workers' and employers' understanding
of many provisions of the beryllium standard. By stating the role that
sensitization plays in the development of CBD in the standard's
definition of chronic beryllium disease, OSHA intends to convey clearly
to the regulated community why protecting workers from becoming
beryllium sensitized is key to the prevention of CBD and why workers
who are confirmed positive for beryllium sensitization should be
offered both a clinical evaluation for CBD and medical removal
protection.
OSHA acknowledges that it is not always necessary to identify a
worker as confirmed positive for beryllium sensitization using the
BeLPT as part of a diagnosis of CBD and that the BeLPT can yield false-
negative results in some individuals. For this reason, an examining
physician should have the latitude to diagnose CBD even in the absence
of a ``confirmed positive'' pattern of BeLPT results. As explained in
the Summary and Explanation of paragraph (k)(7) of the 2017 final rule,
that provision gives the examining physician this latitude (82 FR 2704,
2709). Because the substantive provisions of the standard leave the
examining physician discretion in diagnosing CBD, OSHA does not agree
that acknowledging the role of beryllium sensitization in the
development of CBD will result in diagnostic confusion.
The NSSP recommended the following addition to OSHA's proposed
definition of chronic beryllium disease: ``The presence of interstitial
mononuclear cell (T cell) infiltrates (lymphocytosis) is characteristic
of chronic beryllium disease'' (Document ID 0027, pp. 3-4). The NSSP
argued that the presence of these infiltrates on lung biopsy indicates
the presence of chronic beryllium disease, and should therefore be
included in the standard's definition (Document ID 0027, p. 4). OSHA
disagrees. The agency believes that the term ``granulomatous''
sufficiently addresses the presence of T-cell infiltrates, which occur
at an early stage in the development of granulomas (82 FR at 2492-
2502). As discussed previously, OSHA's intent in defining chronic
beryllium disease is to provide the reader a general understanding of
what CBD is, rather than provide a technical definition for diagnostic
use. The suggested addition is not necessary to describe the nature of
CBD in general terms. With the addition of the term ``granulomatous,''
the definition is sufficiently specific for OSHA's purposes in the
context of paragraph (b).
In summary, for the purposes of this standard OSHA is defining
chronic beryllium disease as a chronic granulomatous lung disease
caused by inhalation of airborne beryllium by an individual who is
beryllium sensitized. This definition is identical to the definition of
chronic beryllium disease OSHA proposed in 2018 and includes only minor
changes from the definition included in the 2017 final standard. OSHA
is providing this definition to enhance stakeholders' general
understanding of the beryllium standard; it is neither intended nor
suitable to provide guidance to medical professionals on the diagnosis
of CBD. OSHA expects these changes to the 2017 definition of chronic
beryllium disease will clarify the standard, and will therefore
maintain safety and health protections for workers.
Confirmed positive.
OSHA is amending the definition of confirmed positive to mean (1)
the person tested has had two abnormal BeLPT test results, an abnormal
and a borderline test result, or three borderline test results,
obtained from tests conducted within a three-year period; or (2) the
result of a more reliable and accurate test indicating a person has
been identified as having beryllium sensitization. The revised
definition includes several changes to the 2017 definition of confirmed
positive and one change from the definition of confirmed positive that
OSHA proposed in the 2018 NPRM.
First, the agency is removing the phrase ``beryllium
sensitization'' from the first sentence of the definition, which
previously stated that a person is confirmed positive if that person
has beryllium sensitization, as indicated by two abnormal BeLPT test
results, an abnormal and a borderline test result, or three borderline
test results. OSHA intends that confirmed positive act only as a
trigger for requirements such as continued medical monitoring and
surveillance for the purposes of this standard, and not as a general-
purpose definition of beryllium sensitization. By removing the phrase
``beryllium sensitization'' from the first sentence of the definition,
the agency hopes to avoid confusion resulting from scientific
disagreements over whether certain test results, such as three
borderlines, necessarily prove that sensitization has occurred. For
purposes of the beryllium
standard, any worker with the BeLPT test results specified in the
definition of confirmed positive should be offered an evaluation for
CBD with continued medical surveillance as well as the option of
medical removal protection, even though some small percentage of
workers who are confirmed positive by this definition may not in fact
be sensitized to beryllium, as is the case for any diagnostic test
(Middleton et al., 2008 (Document ID OSHA-H005C-2006-0870-0480, p.
4)).\12\
---------------------------------------------------------------------------
\12\ In the preamble to the 2017 final rule, OSHA found that
three borderline BeLPT results recognize a change in a person's
immune system with respect to beryllium exposure based on Middleton
et al.'s 2011 finding that three borderline BeLPT results have a
positive predictive value (PPV) of over 90 percent (82 FR at 2501),
and therefore the agency included three borderline results in the
criteria for confirmed positive (82 FR at 2646).
---------------------------------------------------------------------------
Both the USW and Materion supported this proposed revision. The USW
stated that the former definition of confirmed positive had acted ``as
a de facto definition of sensitization'' and that removing the phrase
from this portion of the definition ensures that a finding of confirmed
positive will trigger medical surveillance and medical removal
protection ``without an intermediate stop at a finding of
sensitization'' (Document ID 0033, p. 5). Similarly, Materion commented
that the revised definition allows individuals with three borderline
BeLPT results to obtain the protections of the standard, including
evaluation for CBD and medical removal protection, without necessarily
being ``declared sensitized'' (Document ID 0038, p. 18). Materion
further asserted that the change enhances employee protection by
increasing the number of persons eligible for further testing (Document
ID 0038, p. 19).
NJH opposed the revised definition, asserting that the removal of
the phrase ``beryllium sensitization'' could prevent individuals who
meet the definition of being confirmed positive from being identified
as sensitized. NJH further expressed concern that this could make it
difficult for some workers to access the medical testing and workplace
protections required by the rule (Document ID 0022, p. 4).
The ATS and the AOEC also disagreed with the removal of the phrase
``beryllium sensitization'' from the definition of confirmed positive,
stating the medically accepted interpretation of BeLPT testing results
is that they indicate beryllium sensitization, and that removing this
phrase may cause confusion about what condition the term confirmed
positive refers to (Document ID 0021, p. 3; 0028, p. 2). The ATS
further stated without explanation that removing the term ``beryllium
sensitization'' from the definition of confirmed positive would reduce
worker protections.\13\ The NSSP also expressed disagreement with
OSHA's proposal to remove ``beryllium sensitization'' from the first
part of the confirmed positive definition, but did not state the
reasons for their concern (Document ID 0027, p. 3).
---------------------------------------------------------------------------
\13\ The ATS also asserted that the removal of the phrase
``beryllium sensitization'' would reduce workers' right to file for
worker's compensation (Document ID 0021, p. 3). The ATS did not
explain how the definition of confirmed positive in the beryllium
standard could affect worker's compensation claims and at least one
other commenter questioned the ATS's assertion (see Document ID
0038, p. 19). Regardless, OSHA intends the definition of confirmed
positive to serve only as a trigger for certain provisions of the
beryllium standard. How OSHA defines this phrase for purposes of the
beryllium standard in no way limits healthcare professionals'
ability or incentive to diagnose beryllium sensitization.
---------------------------------------------------------------------------
Following consideration of the concerns raised by these
organizations, OSHA disagrees that removing the phrase ``beryllium
sensitization'' from the first sentence of the definition of confirmed
positive will create confusion or reduce worker protections. The
provisions of the standard intended to benefit workers who may be
sensitized (evaluation at a CBD diagnostic center and medical removal
protection) are available to all workers who meet the definition of
confirmed positive. Therefore, removing the term ``beryllium
sensitization'' from the first sentence of the definition will not
change the access to these benefits for any workers. By removing the
term ``beryllium sensitization'' from the first sentence of the
definition, OSHA seeks to ensure that workers with three borderline
BeLPT results (or other patterns of test results that some physician or
other licensed health care professionals (PLHCPs) may consider
ambiguous) will receive the benefits of the standard regardless of
whether their PLHCP views their results as firm evidence of
sensitization. Furthermore, OSHA disagrees that removing the reference
to ``beryllium sensitization'' will lead to confusion about what the
BeLPT results are supposed to indicate because the second sentence of
the definition of confirmed positive makes clear that a worker who has
been diagnosed with beryllium sensitization would also meet the
definition of confirmed positive: ``It [confirmed positive] also means
the result of a more reliable and accurate test indicating a person has
been identified as having beryllium sensitization.''
An additional change to the definition of confirmed positive
provides that the findings of two abnormal, one abnormal and one
borderline, or three borderline results need to occur from BeLPTs
conducted within a three-year period. This change in the definition of
confirmed positive differs from the proposal and is based on comments
submitted to the record following publication of the 2018 NPRM.
The 2017 final rule did not specify a time limit within which the
BeLPT tests that contribute toward a finding of ``confirmed positive''
must occur. After publication of the 2017 final rule, stakeholders
suggested to OSHA that the definition of confirmed positive could be
interpreted as meaning that findings of two abnormal, one abnormal and
one borderline, or three borderline results over any time period, even
as long as 10 years, would result in the employee being confirmed
positive and automatically referred to a CBD diagnostic center for
evaluation. As discussed in the preamble to the 2017 standard, clinical
evaluation for CBD involves bronchoalveolar lavage and biopsy (82 FR at
2497) which, like all invasive medical procedures, carry risks of
infection and other complications.\14\ Given such risks, and the
possibility that some repeat abnormal or borderline results obtained
over a long period of time could be false positives, it was not the
agency's intent that workers with rarely recurring abnormal or
borderline BeLPT results should necessarily proceed to evaluation at a
CBD diagnostic center unless recommended to do so by their examining
physician. At the same time, OSHA notes that under paragraph
(k)(5)(iii), the licensed physician performing the BeLPT testing
retains the discretion to refer an employee to a CBD diagnostic center
if the licensed physician deems it appropriate, regardless of the BeLPT
result.
---------------------------------------------------------------------------
\14\ 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 (82 FR at
2497).
---------------------------------------------------------------------------
In the 2018 NPRM OSHA proposed that any combination of test results
specified in the definition of confirmed positive must result from the
tests conducted in one cycle of testing, including the initial BeLPT
and the follow-up retesting offered within 30 days of an abnormal or
borderline result (paragraph (k)(3)(ii)(E)). As outlined in proposed
paragraph (k)(3)(ii)(E), an employee would be offered a follow-up BeLPT
within 30 days if the initial test result is anything other than
normal, unless the employee had been confirmed positive (e.g., if the
initial
BeLPT was performed on a split sample and showed two abnormal results).
Thus, for example, if an employee's initial test result was abnormal,
and the result of the follow-up testing offered to confirm the initial
test result was abnormal or borderline, the employee would be confirmed
positive. Alternatively, if the result of the follow-up testing offered
to confirm the initial abnormal test result was normal, the employee
would not be confirmed positive. Any additional abnormal or borderline
results obtained from the next required BeLPT for that employee
(typically, two years later) would not identify that employee as
confirmed positive under the proposed modification to confirmed
positive. OSHA requested comments on the appropriateness of this
proposed time period.
Several stakeholders, including Materion, NJH, the ATS, DOSH, the
NSSP, the AOEC, the USW, and The American College of Occupational and
Environmental Medicine (ACOEM), submitted comments regarding OSHA's
proposal to require that the test results specified in the agency's
definition of confirmed positive must occur within a single testing
cycle. Commenters focused on several aspects of the proposed timing.
First, many of the comments focused on the logistics of OSHA's proposed
change. Materion supported the proposed definition of confirmed
positive, stating that a 30-day allowance for follow-up testing after a
first abnormal or borderline BeLPT result is appropriate to ensure that
testing is completed in a timely manner (Document ID 0038, p. 17).
However, NJH, the ATS, ACOEM, the USW, and the NSSP all indicated that
requiring results with a 30-day testing cycle could create logistical
challenges, for example due to repeat testing requirements or for
businesses in remote areas with limited healthcare facilities (Document
ID 0022, p. 4; 0021, p. 4; 0024, p. 1; 0033, p. 5; 0027, p. 3). In this
final rule and preamble, OSHA clarifies that it did not intend that the
initial and follow-up tests had to be completed and interpreted within
30 days. It intended that the test results used to determine if a
worker is confirmed positive be obtained during one cycle of testing
(i.e., an initial or periodic examination), including follow-up testing
conducted within 30 days of an abnormal or borderline result.
Secondly, stakeholders commented on the appropriateness of limiting
the use of the BeLPT from one test cycle in determining if a worker is
confirmed positive. Materion agreed with the proposed timing and
commented that the change ``increases employee protections by
establishing an employee as confirmed positive in a shorter time frame,
thus, making the medical removal benefit option available to the worker
in a more timely manner'' (Document ID 0038, p. 19). Stakeholders from
the medical community disagreed and raised concerns that limiting test
results to one test cycle would affect the ability to identify workers
who should be referred for a CBD evaluation and receive other
protections under the standard.
The NSSP cited data from healthcare providers to demonstrate that a
30-day testing cycle is insufficient to properly identify sensitized
workers. According to the NSSP, in over 20 years of conducting BeLPTs
in worker populations, Oak Ridge Associated Universities observed
approximate median times of 45 days (range of 3 days to 16 years)
between first and second abnormal tests, 1.5 years (range of 30 days to
11 years) for the abnormal/borderline test combination, and 1 year
(range of 30 days to 11 years) for three borderlines (Document ID 0027,
p. 3). Under the proposed 30-day requirement, the NSSP stated that the
majority of workers who have been identified as sensitized in the past
would not meet the proposed definition of confirmed positive (Document
ID 0027, p. 3).
NJH reported similar findings in new evidence submitted to the
record (Document ID 0022, pp. 4-5). The evidence indicates that many
workers who develop CBD have abnormal or borderline results that do not
immediately repeat upon retesting. To the contrary, many CBD patients
have a series of tests which alternate between normal and abnormal.
Data based on NJH's extensive experience show that the BeLPT does not
yield consistently abnormal results among CBD patients. Of 194 patients
diagnosed with CBD at NJH, the length of time between abnormal results
ranged from 14 days to 5.8 years, with a 95th percentile of 2.9 years.
In this group, 150 patients (or 77 percent) would not have been
evaluated for CBD if two abnormal BeLPT results were required to occur
within a 30-day testing cycle (Document ID 0022, p. 5).
Although the information the NSSP and NJH submitted to the record
is unpublished, their findings are consistent with published studies.
Kreiss et al. (1997) reported that nine individuals had initial
abnormal BeLPT results followed by two normal tests; six of those
individuals were re-tested approximately one year later and four were
confirmed positive for beryllium sensitization based on abnormal BeLPT
results (Document ID OSHA H005C-2006-0870-1360, pp. 610-12). These
findings suggest a high rate of false-negative results and are
consistent with results reported in a study by Stange et al. (2004).
That study found an average false-positive rate of 1.09 percent, and a
false-negative rate of 27.7 percent for the BeLPT (Document ID OSHA-
H005C-2006-0870-1402, p. 459).
Other public health organizations, including DOSH, the ATS, the
NSSP, and the AOEC, agreed with NJH that workers who are sensitized to
beryllium may show varying test results over time; and restricting the
time period for determining ``confirmed positive'' status to 30 days
would cause sensitized individuals to go undetected (Document ID 0023,
p. 2; 0021, p. 2; 0027, p. 3; 0028, p. 2). The ATS and the AOEC
recommended that results from tests performed up to at least three
years after the initial abnormal or borderline test result should be
used to determine whether the person tested is confirmed positive for
beryllium sensitization (Document ID 0021, p. 2; 0028, p. 2). The ATS
stated that a timeframe of at least three years, which encompasses two
rounds of regularly scheduled testing required biennially by the
beryllium standard, would adequately address its concerns regarding
logistical feasibility, would improve diagnostic accuracy, and help
ensure that sensitized workers are identified (Document ID 0021, p. 4).
The AOEC agreed that consideration of BeLPT test results obtained
during a time period of at least three years ``will increase the
potential that workers are accurately diagnosed with beryllium
sensitization [and] will receive the necessary care'' (Document ID
0028, p. 2).
The approaches recommended by the ATS and the AOEC are similar to
the approach NJH used in providing medical surveillance consultation to
workforces that use beryllium. NJH stated that, if an individual's
BeLPT results are abnormal and normal on their initial round of BeLPT
testing, they will usually request another BeLPT within a month. If the
result of that test is normal, they do not request further testing
until the next regularly scheduled BeLPT. If the result of the next
regularly scheduled BeLPT comes back abnormal, they refer the worker
for clinical evaluation even though the tests are separated by the two-
year testing cycle (Document ID 0022, p. 5).
Following consideration of the comments and of the new evidence
submitted to the record following the proposal, OSHA is convinced that
some workers who are ultimately found to be sensitized to beryllium or
diagnosed
with CBD may have alternating abnormal and normal BeLPT results, and
that the time period for abnormal or borderline results to repeat can
be months or years. OSHA is also convinced that requiring two abnormal,
an abnormal and borderline, or three borderline results to occur in one
cycle of an initial or periodic exam before an employee can be
confirmed positive could result in beryllium sensitization or CBD going
undetected in many employees. This is demonstrated by the unpublished
data submitted by NJH showing that a substantial percentage of
individuals with CBD (77 percent) may not have been referred for
further testing based on results obtained within a 30-day cycle of
testing and is confirmed by the experience of the NSSP. Therefore, OSHA
finds that its proposed change would have the unintended and
unacceptable consequence of reducing employee protections because some
employees who are sensitized or have CBD would be deprived of the
benefits available through the standard, such as a timely evaluation at
a CBD diagnostic center. In addition, requiring that results be
obtained in one test cycle is not consistent with the approaches
currently applied or supported by the medical community.
For these reasons, OSHA is revising the definition of confirmed
positive to specify that the findings of two abnormal, one abnormal and
one borderline, or three borderline results must be obtained from
BeLPTs conducted within a three-year period. OSHA agrees with the ATS
and the AOEC that a three-year period will facilitate the
identification of sensitized workers enrolled in medical surveillance
(see Document ID 0022, p. 5; 0028, p. 2). In addition, this approach is
consistent with the practices and recommendations from the medical
community, including NJH, which provides beryllium-related medical
surveillance consultation. OSHA believes that allowing a worker to be
confirmed positive based on BeLPT results obtained over a three-year
time period strikes a reasonable balance that would allow a timely
evaluation for CBD, while at the same time, maintaining OSHA's original
intent that a confirmed positive finding not be based on results
obtained over an indefinite time period.
OSHA emphasizes that this revision does not modify the requirements
of paragraph (k)(3)(ii)(E). Under that paragraph, if the results of the
BeLPT are other than normal, a follow-up BeLPT must be offered within
30 days of receiving the results, unless the employee has been
confirmed positive. Only other than normal BeLPT results must be
followed up within 30 days of the same test cycle (i.e., an initial or
periodic medical examination).
As an example, an employee who receives a borderline result during
one periodic examination conducted in 2020 would be retested within 30
days, and if the follow-up test is normal, testing would stop. That
employee would be offered another BeLPT at the next periodic
examination conducted in 2022. However, if the result of the 2022 test
is borderline, the employee would be retested within 30 days of that
test result receipt, and if the follow-up test is borderline, the
employee would be confirmed positive because of receiving three
borderline tests within three years. A three-year period for the
employee to be confirmed positive would ensure sufficient time for such
follow-up tests that may need to be conducted over two cycles of
medical examinations.
DOD recommended changing the term ``confirmed positive'' to another
term such as ``confirmed non-negative,'' ``confirmed finding of
concern,'' or ``pattern of concern.'' According to the DOD, the term
``confirmed positive'' typically ``implies an initial positive test
that was repeated with another test or another, more sensitive test,
which confirms the initial positive test result'' (Document ID 0029, p.
2). The CBD literature, however, commonly treats individuals as
confirmed positive for sensitization through sequentially conducted
BeLPTs (see, for example, the ATS Statement on Diagnosis and Management
of Beryllium Sensitivity and Chronic Beryllium Disease, ATS 2014,
Document ID OSHA-H005C-2006-0870-0364, p. e41; see also Document ID
OSHA-H005C-2006-0870-1543, 0603, 0398, 1403, 1449). Additionally, OSHA
again emphasizes that terms defined in the beryllium standard are
defined only for purposes of the standard and are not intended as
diagnostic, scientific, or all-purpose definitions. OSHA believes that
its definition of confirmed positive clearly indicates what that term
means for purposes of the beryllium standard and therefore disagrees
with DOD's concern that the term may cause confusion. Accordingly, OSHA
is retaining the term ``confirmed positive'' in this final standard.
Dermal contact with beryllium.
Paragraph (b) of this final rule defines dermal contact with
beryllium as skin exposure to (1) soluble beryllium compounds
containing beryllium in concentrations greater than or equal to 0.1
percent by weight; (2) solutions containing beryllium in concentrations
greater than or equal to 0.1 percent by weight; or (3) visible dust,
fumes, or mists containing beryllium in concentrations greater than or
equal to 0.1 percent by weight. The definition also states that
handling of beryllium materials in non-particulate solid form that are
free from visible dust containing beryllium in concentrations greater
than or equal to 0.1 percent by weight is not considered dermal contact
under the standard. Several of the standard's provisions are triggered
where an employee has, or can be reasonably expected to have, dermal
contact with beryllium. These include provisions in paragraph (f),
Written exposure control plan; paragraph (h), Personal protective
clothing and equipment (PPE); paragraph (i), Hygiene areas and
practices; paragraph (k), Medical surveillance; and paragraph (m),
Communication of hazards.
This final rule makes two changes to the previous definition, which
was added to the standard through the 2018 direct final rule (83 FR at
19940) following OSHA's promulgation of the final rule in January 2017.
That direct final rule defined dermal contact with beryllium as skin
exposure to soluble beryllium compounds, beryllium solutions, or dust,
fumes, or mists containing beryllium, where these materials contain
beryllium in concentrations greater than or equal to 0.1 percent by
weight (83 FR at 19940). First, this final rule modifies the definition
to refer to ``visible'' dust, fumes, or mists containing beryllium in
concentrations greater than or equal to 0.1 percent by weight. Second,
OSHA is adding a sentence to the definition specifying that handling
beryllium materials in non-particulate solid form that are free from
visible dust containing beryllium in concentrations greater than or
equal to 0.1 percent by weight is not considered dermal contact with
beryllium under the standard. This final rule's definition of dermal
contact with beryllium is identical to the definition that OSHA
proposed in the 2018 NPRM.
The revisions incorporated in this definition are intended to help
employers more accurately identify areas where the provisions triggered
by dermal contact apply. Based on feedback OSHA received from
stakeholders following publication of the 2017 final standard, OSHA
became concerned that employers might have difficulty accurately
identifying when and where the provisions triggered by dermal contact
are required. Beryllium-generating processes can release beryllium in
varying particle sizes and amounts, some of which are visible to the
naked eye and some of which are not. OSHA was concerned that
employers could reasonably interpret the provisions triggered by dermal
contact with beryllium (e.g., the use of PPE) as extending to every
employee who could potentially encounter a minute and non-visible
amount of beryllium particulate at its facility, irrespective of the
employee's job duties and tasks, or who might handle an object
containing beryllium. Such an interpretation would be contrary to
OSHA's intent and could prompt employers to attempt infeasible
compliance measures. Therefore, as explained in the 2018 NPRM, OSHA
proposed adding the term ``visible'' to clarify when skin exposure to
beryllium-containing dust, fumes, or mist should be considered dermal
contact with beryllium for the purpose of triggering the standard's
requirements. OSHA also proposed adding a sentence to state that
handling of beryllium materials in non-particulate solid form that are
free from visible dust containing beryllium in concentrations greater
than or equal to 0.1 percent by weight is not considered ``dermal
contact with beryllium'' under the standard.
Several commenters supported revising the definition of dermal
contact with beryllium to apply to visible particulate, agreeing that
the revised definition would facilitate compliance with the standard.
In its submission, Materion stated that the proposed change to the
definition ``clears up the ambiguity and eliminates the vagueness of
the [previous] . . . standard,'' and that
Revising the standard to provide employees as well as employers
clear lines will likely immeasurably help not only with compliance
but with enforcement of the standard. Without the visible cue,
employees will have no idea whether and when they should be
protected by PPE. . . . OSHA has fixed this problem with a sensible
and clear demarcation threshold for dermal contact, and has done so
in a manner that does not sacrifice protection against the risk of
CBD.
(Document ID 0038, p. 21). Similarly, the USW stated that dermal
exposure to beryllium needed to be ``properly addressed,'' but that
triggering provisions by dermal contact with materials containing
beryllium at any level ``could extend the application of the standard
far beyond what OSHA intended or what is necessary to protect workers''
(Document ID 0033, p. 4). The USW referred to non-sparking tools made
from beryllium-copper alloy and beryllium foil used for x-ray windows
as examples of materials where dermal contact should not trigger
provisions of the standard (Document ID 0033, p. 4).
Century Aluminum Company (Century Aluminum) (Document ID 0026, p.
2) and DOD (Document ID 0029, p. 1) also agreed with the proposal to
add the term ``visible'' to the definition. However, DOD recommended
that OSHA revise the definition to explicitly identify skin exposure to
``visible dust that has accumulated on surfaces'' in addition to
visible dust, fumes, or mists containing beryllium in concentrations
greater than or equal to 0.1 percent by weight. OSHA does not believe
this added phrase is necessary. The definition of dermal contact with
beryllium does not distinguish the exposure routes that cause the skin
exposure and, as proposed, the phrase ``visible dust'' encompasses
exposures via both air and surface contamination.
The ATS commented that adding ``visible'' to the definition to
trigger provisions related to dermal contact ``could be helpful,'' but
cautioned that inhalation of beryllium particulate that is not visible
is ``the major concern'' for developing CBD (Document ID 0021, p. 5).
It urged OSHA to ensure that the revised definition neither undermines
the requirements of the beryllium standard which limit exposure to
respirable beryllium, nor limits education on the health effects of
beryllium to only those workers with exposure to visible dust (Document
ID 0021, p. 5).
NJH objected to OSHA's proposal to restrict the definition to
visible dust, fumes, and mists, believing that doing so could reduce
employee protections from beryllium-induced sensitization and disease
(Document ID 0022 p. 7). NJH commented that the smallest respirable
particles are not visible and are inhaled into the deepest part of the
lung. It further commented that a ``monitoring program that routinely
samples all departments with air and wipe samples can accomplish
identifying `nonvisible' dust contamination and should be part of any
industry that needs to comply with an exposure limit'' (Document ID
0022, p. 7). Other commenters voiced similar concerns about the risk
posed by exposure to ultrafine particles containing beryllium,
including the NSSP (Document ID 0027, p. 3), the AOEC (Document ID
0028, p. 2), and DOSH (Document ID 0023, p. 2).
OSHA agrees that exposure to airborne beryllium, even when not
visible to the naked eye, is an important risk factor for developing
CBD and that it would be inappropriate to rely on the presence of
visible airborne particulate to assess workers' exposure to airborne
beryllium and the need to implement engineering and work practice
controls or respiratory protection. The standard's permissible exposure
limits and requirements for quantitative exposure assessments and use
of respiratory protection are of paramount importance for ensuring that
workers are protected from CBD, and these requirements are unaffected
by the changes to the dermal contact with beryllium definition. In
addition, the standard's requirements to train workers on the health
hazards of exposure to beryllium and on the employer's exposure control
plan (paragraph (m)(4)) apply to all employees within the scope of the
general industry standard who have, or can reasonably be expected to
have, airborne exposure (regardless of the size fraction) to or dermal
contact with beryllium, thus including all workers that would be
considered to be potentially at risk of beryllium-related disease.\15\
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\15\ NJH also asserted that ``[a]ll workers in a beryllium using
industry should receive beryllium education with programs tailored
to specific jobs and processes'' (Document ID 0022, p. 7). Mount
Sinai Selikoff Centers for Occupational Health similarly advocated
for ``intensive training and protective gear for all workers who may
be at risk of beryllium exposure'' (Document ID 0032, p. 3). OSHA
notes that the beryllium standard has never required all workers in
a beryllium-using industry to receive training. Rather, the standard
has always required training for those workers who have or are
reasonably expected to have airborne exposure to beryllium
regardless of the size fraction. The standard continues to require
training for all such workers.
---------------------------------------------------------------------------
DOSH advocated for surface sampling as being a ``practical method''
for assessing exposure and asserted that adopting a ``specific
numerical surface contamination criterion'' to assess dermal contact
hazard was a more protective strategy. DOSH further suggested that, in
establishing this numerical criterion, OSHA ``consider levels that
could result in uptake of beryllium by workers at rates similar to
action level airborne exposures'' (Document ID 0023, p. 2).
With respect to inhalation hazards associated with beryllium, OSHA
agrees that relying on the visibility of particulate does not
adequately protect workers from CBD or lung cancer, and that both
conducting routine air sampling and ensuring no employees are exposed
to airborne beryllium in excess of the PELs are essential to minimizing
workers' exposures to airborne particulate. The TWA PEL for beryllium
is based on robust evidence from studies of beryllium workers that
permitted the agency to determine that there is significant risk of
sensitization, CBD, and lung cancer associated with the previous TWA
PEL, and that this
risk would be substantially reduced by the new PEL (82 FR at 2545-52).
Unlike the case for inhalation, the available data on the effects
of dermal contact with beryllium make it difficult to establish a
reasonably precise, objective limit on surface contamination above
which protective measures should be triggered. The most recent effort
to derive a health-based measure of surface cleanliness for beryllium
was that of Shay et al. (Document ID H005C-2006-0870-0417), who used
models that accounted for particulate dissipation, resuspension into
air, transfer efficiency from surface to skin, dermal absorption of
particulate through intact or damaged skin, and other factors. The
authors used these models along with both oral and inhalation toxicity
values derived by the Environmental Protection Agency to relate the
level of surface contamination to target risk values for cancer and
noncancer effects that would generally be considered to be de minimis
(i.e., an exposure associated with either a lifetime cancer risk of one
death per million persons exposed, or no excess risk of adverse
noncancer effects). After accounting for these factors, the resulting
surface dust cleanup criteria for each health endpoint ranged over
several orders of magnitude, reflecting a high degree of uncertainty
(for the noncancer endpoint, the criteria ranged from 5 to 370
[micro]g/cm\2\ for damaged skin, and from 17 to 3,337 [micro]g/cm\2\
for intact skin; for cancer, the criteria ranged from 51 to 485
[micro]g/cm\2\).
This study illustrates the difficulty in establishing a reliable
and objective risk-based limit on surface contamination that could be
used to trigger measures that would prevent dermal contact with
beryllium particulate when such contact is sufficient to contribute to
a significant risk of disease. Absent an objective measure, OSHA finds
that it is preferable to base the definition of dermal contact with
beryllium on a clear, qualitative indicator of when dermal contact is
occurring or is reasonably anticipated to occur so that employers can
have assurance that they are in compliance with the provisions that are
triggered by dermal contact. Accordingly, the final rule's definition
of dermal contact with beryllium refers to skin exposure to visible
dusts, fumes, or mists, as well as to soluble compounds and solutions
of beryllium, as was proposed. As stated above, OSHA expects that
revisions in this final rule will maintain worker protections.
NJH also objected to defining dermal contact with beryllium when
handling finished beryllium products only by the presence of visible
dust, asserting that gloves are warranted because beryllium could
oxidize on the surface (Document ID 0022, p. 7). However, for the
reasons explained below, OSHA considers these comments to be beyond the
scope of the proposal. The agency also notes that the revision NJH's
comment refers to merely clarifies the meaning of the 2017 standard,
rather than modifying it substantively.
OSHA's revision to the definition of dermal contact with beryllium
clarifies OSHA's intent that the provisions in the standard related to
dermal contact with beryllium do not apply to the handling of solid
beryllium-containing objects that the employer does not process, unless
visible beryllium particulate has contaminated the surface of the
object. OSHA explained in the 2017 final rule that beryllium-containing
solid objects, or ``articles,'' with uncompromised physical integrity
are unlikely to release beryllium that would pose a health hazard for
workers (82 FR at 2640). An article, by definition, ``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'' (29 CFR
1910.1200(c)). The agency therefore excluded articles that contain
beryllium, and that the employer does not process, from the scope of
the 2017 beryllium standard (see paragraph (a)(3)). OSHA did not intend
for the 2018 NPRM to open the agency's underlying findings on the
handling of beryllium-containing articles, nor their exclusion from the
scope of the standard, for notice and comment. To the extent NJH's
comment challenges the articles exemption, these comments are beyond
the scope of the proposal.
Nevertheless, even for those solid beryllium-containing objects
that do not fall under the definition of an article, such as ingots
that might be processed further, OSHA notes that PPE would be required
if there is a reasonable expectation that oxidation may result in
visible surface contamination. In its comments on the 2015 NPRM,
Materion explained that beryllium oxides are created through particular
manufacturing processes, typically those involving heating of the
beryllium-containing materials (e.g., hot forming operations, melting,
or heat treating) (see Document ID OSHA-H005C-2006-0870-1662, p. 16).
These operations may give rise to a reasonable expectation of dermal
contact due to the expected oxidization that will occur as a result of
the process. Where there is a reasonable expectation that oxidization
may result in visible surface contamination, an employer must not wait
for the surface to be contaminated to require PPE for potentially
exposed employees. For example, if the surface of a solid object must
be heat treated, and the employer has reason to believe this will
result in surface oxidation absent cleaning the surface, PPE would be
required under this final rule.
After carefully considering the record of public comments on this
topic, OSHA finds that the revised definition of dermal contact with
beryllium will provide a clearer and more workable definition, without
reducing worker protections. The specification of ``visible dust,
fumes, or mists containing beryllium in concentrations greater than or
equal to 0.1 percent by weight'' and clarification regarding beryllium-
containing articles will allow employers to accurately identify the
employees, particularly those working outside of beryllium work areas
or regulated areas, to whom the provisions triggered by dermal contact
with beryllium apply, including the requirement in paragraph (h) to
provide employees with PPE to protect against reasonably expected
dermal contact with beryllium. The revised definition will also render
more workable the additional provisions in the standard that are
triggered by dermal contact with beryllium, which include provisions in
paragraph (f), Written exposure control plan; paragraph (i), Hygiene
areas and practices; paragraph (k), Medical surveillance; and paragraph
(m), Communication of hazards.
This final rule better addresses the practical aspects of a
``reasonable expectation'' trigger for PPE than did the previous rule,
which could have been read as effectively requiring employees to wear
PPE facility-wide, even when not in proximity to beryllium generating
processes, such as in administrative offices. OSHA believes that use of
PPE in that circumstance is unwarranted and would not meaningfully
enhance worker protections against beryllium exposure. Where an
employer has a reasonable expectation that even very small amounts of
beryllium dust, fume, or mist might spread outside of beryllium work
areas, they might have interpreted the language of the previous rule to
require all employees in the facility to wear PPE all of the time. OSHA
did not intend and did not cost the previous rule as requiring PPE to
protect against dermal contact with non-visible beryllium dust, fumes,
or mists outside of beryllium work areas. The addition of a visual cue
will enable employers to accurately identify the employees outside of
beryllium work
areas who need to wear PPE due to their reasonably-expected dermal
contact with beryllium.
As OSHA explained in the 2018 NPRM (83 FR at 63752), the agency
expects that the use of PPE will always be required in beryllium work
areas because both the operations listed in Appendix A and those that
can be reasonably expected to generate exposure at or above the action
level would create a reasonable expectation of dermal contact with
beryllium. This expectation is based, in part, on a study conducted by
NIOSH and Materion and published in the Journal of Occupational and
Environmental Hygiene (Document ID OSHA-H005C-2006-0870-0502, p. 791).
In the 2018 NPRM, OSHA explained that this study identified a strong
correlation between airborne beryllium concentrations and the amount
measured on gloves worn by workers at multiple beryllium facilities and
jobs, indicating the potential for skin exposure where airborne
beryllium is present. The study further concluded that this correlation
implies that one type of measurement can be indicative of other
exposure pathways (Document ID OSHA-H005C-2006-0870-0502, p. 791). OSHA
further explained that the expectation of dermal contact within
beryllium work areas is also based on OSHA's review of data collected
during site visits conducted by the agency that cover a wide range of
processes (e.g., furnace and melting operations, casting, grinding/
deburring, machining and stamping) and a wide range of materials
including beryllium composite, beryllium alloy, and beryllium oxide.
The data show that those operations that would create a reasonable
expectation of dermal contact, either through beryllium surface
contamination or skin contamination, are covered either by proposed
Appendix A or have exposures above the action level (see Document ID
OSHA-H005C-2006-0870-0341).
In its comment, Materion questioned OSHA's reliance on the 2007 Day
et al. study (82 FR at 2488-89) and suggested that, contrary to OSHA's
statement, Day did not identify a ``strong correlation'' between
airborne concentrations and skin exposure (Document ID 0038, pp. 13-
14). Materion cited Day's finding of a potential for greater transfer
of beryllium from surfaces to cotton gloves that could lead to an
overestimation of the amount of beryllium transferred. OSHA disagrees
with Materion's assessment of the Day study. Day indicates that the
underlying assumption that glove-sampling techniques actually remove
the majority of the contamination may be overstated and that the
surface and skin wipe samples may underestimate the mass of beryllium
that is present. The Day study demonstrates that there is a correlation
between airborne and potential for skin exposures (Document ID OSHA-
H005C-2006-0870-1548, p. 79).
As OSHA discussed in the NPRM, this finding is supported by a
follow-up study by Armstrong et al. (2014) conducted at four different
Materion manufacturing locations over a wide variety of jobs. This
study also showed strong positive correlations between air, dermal, and
surface exposures among the four different facilities that process
beryllium (Document ID OSHA-H005C-2006-0870-0502, p. 791). The study
further concludes that this correlation implies that one type of
measurement can be indicative of other exposure pathways. OSHA finds
that these studies demonstrate a correlation between airborne exposure
and the reasonable expectation of dermal contact.\16\
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\16\ Materion also asserted that the evidence in the record is
insufficient to conclude that ``dermal contact alone is sufficient
to create a significant risk of CBD or even beryllium
sensitization'' (Document ID 0038, pp. 14-15). However, in the 2017
final rule, OSHA specifically found that that dermal exposure can
result in sensitization (see 82 FR at 2489). The 2018 NPRM did not
propose revisiting this finding.
---------------------------------------------------------------------------
In the 2018 NPRM, OSHA specifically requested comments on whether
processes exist that could trigger the creation of a beryllium work
area, but could be reasonably expected to release only non-visible
beryllium-containing dusts, fumes, or mists. No commenter provided
evidence of such processes. Materion asserted that OSHA should not
``automatically classify'' beryllium work areas as having a reasonable
expectation of dermal contact because this would serve as ``a serious
disincentive for employers to eliminate exposure meeting the definition
of dermal contact'' (Document ID 0038, p. 15). However, Materion did
not explain how such a presumption would serve as a disincentive and,
more importantly, did not identify any process that could trigger the
creation of a beryllium work area while not also, in fact, creating a
reasonable expectation of dermal contact.
Accordingly, OSHA reaffirms its expectation that both the
provisions associated with beryllium work areas (listed above) and the
provisions associated with dermal contact with beryllium would apply to
employees in a beryllium work area. OSHA expects that employers will,
for each beryllium work area, assess the PPE needs as required by
paragraph (f)(1) and OSHA's Personal Protective Equipment standards
(subpart I of 29 CFR 1910) and provide their employees with appropriate
PPE.
Because it will help employers identify which employees have, or
can be reasonably expected to have, dermal contact with beryllium, the
revised definition will allow employers to more accurately comply with
the requirement in paragraph (f)(1)(i)(A) to establish, implement, and
maintain a written exposure control plan that includes a list of
operations and job titles reasonably expected to involve airborne
exposure to or dermal contact with beryllium. OSHA expects that the
list would likely include all operations and job titles in beryllium
work areas, along with any additional operations or job titles for
employees whose skin could be exposed to visible beryllium dust, fumes,
or mists in concentrations of 0.1 percent by weight or more. Under the
previous definition, employers could have reasonably interpreted the
standard as requiring them to list the job title for every employee at
the facility who could come into contact with a minute and non-visible
amount of beryllium particulate, including employees who do not work in
proximity to beryllium-releasing processes.
Similarly, the revised definition will facilitate employer
compliance with the requirement to provide information and training (in
accordance with the Hazard Communication standard (29 CFR 1910.1200(h))
to each employee who has, or can reasonably be expected to have,
airborne exposure to or dermal contact with beryllium by the time of
the employee's initial assignment and annually thereafter (paragraphs
(m)(4)(i)(A)-(C)). Under this requirement, employees entitled to
training include all employees who work in beryllium work areas and any
other employees who may not be working directly with a beryllium-
generating process, but who may nonetheless reasonably be expected to
have airborne exposure to and/or skin contact with soluble beryllium,
beryllium solutions, or visible beryllium dust, fumes, or mists in
concentrations of 0.1 percent by weight or more. As discussed
previously, OSHA intends the revised definition of dermal contact with
beryllium to provide employers with a workable indicator for
determining which employees outside of beryllium work areas should
receive this information and training.
Because the change would allow employers to more accurately
identify areas where provisions related to dermal contact should apply,
the revised
definition would also facilitate proper compliance with paragraph
(i)(1)(ii), which requires employers to ensure 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. OSHA's revisions to the definition of dermal contact with
beryllium would prevent employers from speculating that all employees
in a facility, including those employees who do not work near
beryllium-releasing processes, must wash their exposed skin because
they might have come into contact with non-visible beryllium
particulate or handled articles that contain beryllium. Such an
interpretation would be contrary to OSHA's intent.
The revised definition is designed to further improve employer
compliance with the requirements in paragraph (k) to offer employees a
medical examination including a medical and work history that
emphasizes past and present airborne exposure to or dermal contact with
beryllium (paragraph (k)(3)(ii)(A)), and to provide the examining
physician or other licensed health care professional (PLHCP) (and the
agreed-upon CBD diagnostic center, if such an evaluation is required)
with a description of the employee's former and current duties that
relate to the employee's airborne exposure to and dermal contact with
beryllium (paragraph (k)(4)(i)). Because it would improve employers'
ability to identify when dermal contact with beryllium has occurred or
could occur, this change would permit employers to accurately complete
employee medical and work histories and the reports that they must
provide to examining PLHCPs or CBD diagnostic centers. As with the
provisions discussed above, OSHA's revisions to the definition of
dermal contact with beryllium will prevent employers from including
superfluous information in these medical and work histories and reports
because they are concerned that an employee might have conceivably had
skin contact with minute, non-visible beryllium particulate or handled
beryllium-containing articles outside of a beryllium work area. Such an
expansive interpretation is again contrary to OSHA's intent.
OSHA is adding two references to dermal contact with beryllium in
paragraph (i), Hygiene areas and practices, to account for the final
rule's changes to the definition of beryllium work area in paragraph
(b). Paragraph (i) in the previous rule included requirements for
employers to provide each employee working in a beryllium work area
with readily accessible washing facilities (paragraph (i)(1)(i)) and a
designated change room where employees are required to remove their
personal clothing (paragraph (i)(2)). But, as explained earlier in this
section, OSHA is revising the definition of beryllium work area so that
the requirement to establish these areas is no longer triggered on the
potential for dermal contact with beryllium.
OSHA intends for the washing facilities and change rooms
requirements to apply where employees are reasonably expected to have
dermal contact with beryllium, regardless of whether they work in a
beryllium work area, as now defined in this final rule. As discussed
above, there may be employees outside of the beryllium work area that
may have a reasonable expectation of dermal contact with beryllium.
Therefore, as was proposed, OSHA is adding two additional references to
dermal contact with beryllium to paragraph (i). First, OSHA is revising
paragraph (i)(1) so that the requirements would apply to each employee
who works in a beryllium work area or who can reasonably be expected to
have dermal contact with beryllium. Paragraph (i)(1)(i) would then
require employers to provide washing facilities to all employees who
can be reasonably expected to have dermal contact with beryllium.
Second, OSHA is revising paragraph (i)(2) so that employers are
required to provide change rooms to employees who are required to use
personal protective clothing or equipment under paragraph (h)(1)(ii),
if those employees are required by the employer to remove their
personal clothing. Because paragraph (h)(1)(ii) requires the use of PPE
where there is a reasonable expectation of dermal contact with
beryllium, the change to paragraph (i)(2) ensures that the requirement
for change rooms would continue to protect those employees who can
reasonably be expected to have dermal contact with beryllium.
Methods of Compliance.
Paragraph (f) of the beryllium standard for general industry
contains provisions covering 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) sets forth the
requirements for written exposure control plans. Paragraph (f)(1)(i)
requires employers to establish, implement, and maintain such a plan,
and paragraphs (f)(1)(i)(A)-(H) specifies the information and
procedures that must be included in the plan. Paragraph (f)(1)(ii)
directs employers to review and evaluate each plan at least annually
and update it under specified circumstances.
In the 2018 NPRM, OSHA proposed two wording changes to paragraph
(f)(1) (83 FR at 63754). The first proposed change relates to the
contents of the written exposure control plan. Under paragraph
(f)(1)(i)(D), employers were previously required to include procedures
in their plans for minimizing cross-contamination, ``including
preventing the transfer of beryllium'' between surfaces, equipment,
clothing, materials, and articles within beryllium work areas. OSHA
proposed removing the word ``preventing'' from the regulatory text to
clarify that these procedures may not totally eliminate the transfer of
beryllium, but should minimize cross-contamination of beryllium,
including between surfaces, equipment, clothing, materials, and
articles.
The second proposed change involves one of the circumstance when
employers must update their written exposure control plans. Paragraph
(f)(1)(ii)(B) of the standard directed employers to update the written
exposure control plan, as necessary, when they are notified that an
employee is eligible for medical removal in accordance with paragraph
(l)(1), referred for evaluation at a CBD diagnostic center, or shows
signs or symptoms associated with ``airborne exposure to or dermal
contact with beryllium.'' In the 2018 NPRM, OSHA proposed to replace
the phrase ``airborne exposure to and dermal contact with beryllium''
with ``exposure to beryllium.'' The agency explained that the change
would simplify the language of the provision while still capturing all
potential exposure scenarios currently covered. Because these proposed
changes are merely clarifying, OSHA explained that it expected that
they would maintain safety and health protections for workers.
All of the stakeholders that submitted comments related to OSHA's
proposed changes to the written exposure control plan provisions
supported the changes (see, e.g., Document ID 0031, p. 2; 0038, p. 31).
For example, EEI observed that OSHA's discussion of the proposed
changes were appropriate modifications to the beryllium standard
(Document ID 0031, p. 2). Materion also supported the proposed changes
and agreed with OSHA that these proposed changes are merely clarifying,
and that they will maintain safety and health protections for
employees. In addition, Materion noted that it ``identifie[d] no
reduction
in protection to employees associated with these clarifying language
revisions'' (Document ID 0038, p. 31).
After reviewing these comments and considering the record as a
whole, OSHA has determined that the proposed changes will clarify for
employers the requirements of the written exposure control plan without
sacrificing safety and health protections for workers. Therefore, OSHA
is finalizing the proposed changes to paragraph (f) in this final rule.
Personal Protective Clothing and Equipment.
Paragraph (h) of the beryllium standard for general industry
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, or where there
is a 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 this standard. As explained in
the 2017 final rule preamble, these PPE requirements are intended to
protect employees by preventing dermal exposure to beryllium and the
accumulation of airborne beryllium on PPE, and to protect employees and
other individuals both inside and outside the workplace from exposures
that could occur if contaminated clothing were to transfer beryllium
(82 FR at 2678).
In the 2018 NPRM, OSHA proposed two changes to paragraph (h). The
first revision relates to paragraph (h)(2)(i), which addresses removal
and storage of PPE. Paragraph (h)(2)(i) previously required employers
to ensure that each employee removes all beryllium-contaminated PPE at
the end of the work shift, ``at the completion of tasks involving
beryllium,'' or when PPE becomes visibly contaminated with beryllium,
whichever comes first. OSHA proposed modifying the phrase ``at the
completion of tasks involving beryllium'' by changing ``tasks'' to
``all tasks,'' so that it reads ``at the completion of all tasks
involving beryllium'' (83 FR at 63754).
OSHA explained in the 2018 NPRM that this revision to paragraph
(h)(2)(i) merely clarifies the trigger for when employees must remove
beryllium-contaminated PPE, consistent with the agency's original
intent (83 FR at 63754). As expressed in the preamble to the 2017 final
rule, OSHA intended that PPE contaminated with beryllium should not be
worn after tasks involving beryllium exposure have been completed for
the day (82 FR at 2682). Thus, when employees perform multiple tasks
involving beryllium successively or intermittently throughout the day,
the employer must ensure that each employee removes all beryllium-
contaminated PPE at the completion of the set of tasks involving
beryllium, not necessarily after each separate task. If, however,
employees perform tasks involving beryllium exposure for only a portion
of a work shift, and then perform tasks that do not involve exposure to
beryllium, the employer must ensure that employees remove their PPE
after the beryllium exposure period. Unless the PPE becomes visibly
contaminated with beryllium, OSHA did not intend this provision to
require multiple PPE changes throughout the work shift. Thus, the
proposed revision to paragraph (h)(2)(i) clarifies OSHA's original
intent.
OSHA received multiple comments in support of the proposed change
to paragraph (h)(2)(i). The USW commented that it believes the change
is reasonable and clarifies the intent of the standard (Document ID
0033, p. 6). Similarly, Century Aluminum expressed its support for this
``sensibl[e]'' revision, commenting that it is an example of a logical
and workable requirement that will produce better work practices and
habits and, in turn, improve employee health and safety outcomes
(Document ID 0026, p. 2). In addition, Century Aluminum commented that
requiring PPE to be changed after every task would ``significantly
increase costs without increasing employee health and safety'' and
could actually increase the amount of time employees are exposed to
beryllium, thus increasing their risk of sensitization and disease
(Document ID 0026, p. 2). Materion also expressed its general support
for the ``clarifying language revisions'' to paragraph (h) (Document ID
0038, p. 32).
OSHA also received two comments opposing the proposed change to
paragraph (h)(2)(i). A private citizen commented that, although OSHA
did not intend to require continuous PPE changes throughout a work
shift, doing so seemed necessary to limit transmission of contaminant
between workers and work areas (Document ID 0017). And another private
citizen commented that if a worker's suit is contaminated, the worker
should be required to change even if the suit is not visibly
contaminated (Document ID 0019).
OSHA does not believe it is necessary for workers to change PPE
after each work task, or after each instance of PPE contamination, in
order to limit the spread of beryllium particulate between work areas
because, absent visible contamination of PPE, any contamination present
will likely be minute and will not contaminate other work areas to such
a degree as to materially increase worker exposures. Furthermore, as
explained in the preamble to the 2017 final rule (82 FR at 2682),
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. Moreover, the process of
changing contaminated PPE can create opportunities for both inhalation
exposure and dermal contact with beryllium. Accordingly, the use of
``visibly contaminated'' protects employees from potential exposures
while changing PPE by limiting the requirement 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.
Notably, the USW commented that it believes including the term
``visibly contaminated'' in the provision provides for employee safety
(Document ID 0033, pp. 6-7), and Materion similarly stated that
``visibility [of beryllium-contaminated PPE and equipment] is a
conservative, stringent'' trigger that ``also has the benefit of
compliance clarity'' (Document ID 0038, p. 32). After reviewing these
comments and considering the record as a whole, OSHA finds that the
proposed change in paragraph (h)(2)(i) is reasonably necessary and
appropriate and has retained the revised language in the final rule.
The second proposed revision relates to paragraph (h)(3)(iii),
which addresses cleaning and replacement of PPE. This paragraph
required employers to inform in writing the persons or the business
entities who launder, clean, or repair the PPE required by this
standard of the potentially harmful effects of ``airborne exposure to
and dermal contact with beryllium.'' The 2018 NPRM proposed replacing
the phrase ``airborne exposure to and dermal contact with beryllium''
with ``exposure to beryllium'' (83 FR at 63755). OSHA explained that
this change simplifies the language of the provision while still
capturing all potential exposure scenarios currently covered; and, as
such, the agency concluded that the revised language will maintain
safety and health protections for workers. OSHA received no comments on
this proposed change beyond Materion's general support for the
clarifying revisions to paragraph (h) as a whole (Document ID 0038, p.
32). OSHA is therefore retaining the proposed revision to paragraph
(h)(3)(iii) in the final rule.
Hygiene Areas and Practices.
Paragraph (i) of the beryllium general industry standard requires
that the employer provide employees with readily accessible washing
facilities, change rooms, and showers when certain conditions are met;
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. As explained in the 2017 final rule,
OSHA believes that strict compliance with these provisions will reduce
the amount and duration of employees' airborne exposure and dermal
contact with beryllium (82 FR at 2683-88).
In the 2018 NPRM, OSHA proposed three changes to paragraph (i) of
the general industry standard. The agency proposed the first two
changes (83 FR at 63755), which apply to paragraphs (i)(1) and (i)(2),
to maintain the protections included in these paragraphs for employees
who have dermal contact with beryllium notwithstanding the proposed
change to the definition of beryllium work area, discussed previously
in this Summary and Explanation. OSHA proposed the third change, which
applies to paragraph (i)(4), to clarify the requirements for cleaning
beryllium-contaminated PPE prior to entering an eating or drinking area
(83 FR at 63755-56).
As explained in the previous discussion of changes to the
definition of beryllium work area, OSHA proposed and has finalized
these changes to the definition of beryllium work area to clarify where
a beryllium work area must be established. One of these changes removes
dermal contact with beryllium as one of the triggers that requires an
employer to establish a beryllium work area. As explained in the 2018
NPRM, OSHA intended for the hygiene provisions related to washing
facilities and change rooms to continue to apply to all employees who
can reasonably be expected to have dermal contact with beryllium,
regardless of whether they work in beryllium work areas as defined in
the revised definition (83 FR at 63755). OSHA accordingly proposed two
changes.
First, OSHA proposed a change in the wording of paragraph (i)(1),
which required that ``[f]or each employee working in a beryllium work
area,'' the employer must provide readily accessible washing facilities
to remove beryllium from the hands, face, and neck; and ensure that
employees who have dermal contact with beryllium wash any exposed skin
at specific designated times. The 2018 NPRM proposed amending the
language to apply to ``each employee . . . who can reasonably be
expected to have dermal contact with beryllium,'' in addition to each
employee working in a beryllium work area (83 FR at 63768).
Second, OSHA proposed a change in the wording of paragraph (i)(2),
which required employers to provide ``employees who work in a beryllium
work area,'' with a designated change room where employees are required
to remove their personal clothing. OSHA proposed revising paragraph
(i)(2) to require employers to provide a designated change room to
employees who are required to use personal protective clothing or
equipment under paragraph (h)(1)(ii) of the beryllium standard, instead
of to employees who work in a beryllium work area (83 FR at 63768).
Paragraph (h)(1)(ii) of the beryllium standard requires the provision
and use of appropriate PPE where there is a reasonable expectation of
dermal contact with beryllium. The requirement to provide change rooms
would continue to apply only where employees are required to remove
their personal clothing. As noted above and explained in the 2018 NPRM,
the proposed changes to paragraphs (i)(1) and (i)(2) were merely
intended to ensure that the hygiene provisions related to washing
facilities and change rooms would continue to protect employees who are
reasonably expected to have dermal contact with beryllium, if the
agency adopted the proposed revised definition of the term beryllium
work area.
OSHA also proposed a third change, which applies to paragraph
(i)(4), in order to clarify the requirements for cleaning beryllium-
contaminated PPE prior to entering an eating or drinking area.
Paragraph (i)(4)(ii) required the employer to ensure that no employees
enter any eating or drinking area with beryllium-contaminated 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.
In the 2018 NPRM, OSHA proposed to modify this paragraph to require the
employer to ensure that, before employees enter an eating or drinking
area, beryllium-contaminated PPE is cleaned, as necessary, to be as
free as practicable of beryllium by methods that do not disperse
beryllium into the air or onto an employee's body (83 FR at 63768). The
agency explained that this proposed change would clarify that OSHA does
not expect the methods used to clean PPE prior to entering an eating or
drinking area to completely eliminate residual beryllium from the
surface of the PPE if complete elimination is not practicable (83 FR at
63755-56). OSHA also explained that this is consistent with its
determination, expressed in the preamble to the 2017 final rule, that
``as free as practicable'' is ``the most appropriate terminology for
requirements pertaining to surface cleanliness'' (82 FR at 2687). This
proposed clarification also aligns the language of paragraph (i)(4)(ii)
with the language of paragraph (i)(4)(i), which requires employers to
ensure that beryllium-contaminated surfaces in eating and drinking
areas are as free as practicable of beryllium. Finally, OSHA explained
that requiring cleaning only ``as necessary'' would clarify that
cleaning would not be required if the PPE is already as free as
practicable of beryllium. OSHA stated that it expected these proposed
changes to paragraph (i) would maintain safety and health protections
for workers.
Commenters expressed broad support for OSHA's proposed changes to
paragraph (i) (see, e.g., Document ID 0029, p. 1; 0031, p. 2; 0033, p.
6; 0038, p. 32). For example, EEI observed that the proposed changes to
this paragraph as a whole were appropriate modifications to the
beryllium standard (Document ID 0031, p. 2) and DOD generally agreed
with the proposed changes, commenting that they are evidence based and
provide greater employee protections (Document ID 0029, p. 1). Materion
also supported the proposed changes to paragraph (i) as a whole, and
agreed with OSHA that these proposed changes are merely clarifying, and
that they will maintain safety and health protections for employees
(Document ID 0038, p. 32; see also Document ID 0034 and 0035, p. 1
(supporting and endorsing the comments submitted by Materion)).
OSHA did not receive any comments that specifically addressed the
two proposed changes to paragraphs (i)(1) and (i)(2). The agency is
therefore
adopting the changes to those paragraphs as proposed.
Stakeholders also did not submit any comments on the majority of
the agency's proposed changes to paragraph (i)(4). A DOD comment
specifically addressed the term ``as free as practicable,'' suggesting
that because the term is not defined, OSHA should require employers to
establish procedures for cleaning PPE, document accomplishment of
procedures, and periodically review compliance with cleaning procedures
(Document ID 0029, p. 2). The USW supported the proposed change for
cleaning PPE ``as necessary,'' agreeing with OSHA's explanation in the
2018 NPRM that requiring cleaning only as necessary would clarify that
cleaning would not be required if the PPE is already as free as
practicable of beryllium (Document ID 0033, p. 6).
The requirement to maintain surfaces as free as practicable of a
regulated substance is included in other OSHA health standards, such as
those for lead (29 CFR 1910.1025, 29 CFR 1926.62), chromium (VI) (29
CFR 1910.1026), and asbestos (29 CFR 1910.1001), and is used elsewhere
in the beryllium general industry standard (29 CFR
1910.1024(f)(1)(i)(E), (i)(4)(i), (j)(1)(i), (j)(3)(ii)). 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, including
beryllium, as well as guidance from OSHA on compliance with such
requirements. OSHA discussed the meaning of this phrase in the Summary
and Explanation of paragraph (j) in the 2017 final rule (82 FR at
2690), as well as in a 2014 letter of interpretation explaining the
phrase in the context of the agency's standard for chromium (VI) (OSHA,
Nov. 5, 2014, Letter of Interpretation, available at https://www.osha.gov/laws-regs/standardinterpretations/2014-11-05). As OSHA
explained in the 2014 letter of interpretation, OSHA evaluates whether
a surface is ``as free as practicable'' of a contaminant by the
efficacy of the employer's program to keep surfaces clean. OSHA intends
for this term to be broad and performance-oriented, so as to allow
employers in a variety of industries flexibility to decide what type of
control methods and procedures are best suited to their beryllium
operations, and OSHA intends to evaluate compliance based on employer
efforts under the circumstances present at each facility. Notably, in
its comment, Materion expressed general support for use of the phrase
``as free as practicable'' in other parts of the standard,
acknowledging that this is the workable legal standard OSHA relies on
in occupational health standards (Document ID 0038, pp. 25-26, 33).
Moreover, as to DOD's recommendation that OSHA require employers to
establish procedures for cleaning PPE, document accomplishment of
procedures, and periodically review compliance with cleaning procedures
(Document ID 0029, p. 2), OSHA agrees that requiring employers to
establish PPE cleaning procedures is important. To meet this objective,
the written exposure control plan provision in paragraph (f)(1)(i)
requires employers to establish, implement, and maintain a written
exposure control plan, which must contain, among other things,
procedures for removing, laundering, storing, cleaning, repairing, and
disposing of beryllium-contaminated personal protective clothing and
equipment, including respirators. Paragraph (f)(1)(ii) requires
employers to review and evaluate the effectiveness of each written
exposure control plan at least annually and update it, as necessary, if
certain specified events occur. OSHA believes that these requirements
satisfy DOD's concerns while still allowing employers the flexibility
to establish, implement, and maintain a plan that works best for their
individual workplaces.
After reviewing these comments and considering the record as a
whole, OSHA believes that the term ``as free as practicable'' is
understood by employers through its use in other standards and as
explained in letters of interpretation and other guidance, and does not
believe that defining the term in this standard or establishing
specific PPE cleaning and documentation procedures is necessary. OSHA
also believes the proposed change is necessary to align the language of
paragraphs (i)(4)(i) and (i)(4)(ii). OSHA did not receive any comments
objecting to the revised requirement that PPE be ``cleaned, as
necessary,'' which makes clear that cleaning would not be required if
PPE is already as free as practicable of beryllium. OSHA believes these
changes clarify the agency's intent without sacrificing safety and
health protection for workers. The agency is therefore adopting the
changes as proposed to paragraph (i)(4)(ii) in this final rule.
Disposal, Recycling, and Reuse.
Paragraph (j) of the beryllium general industry standard requires
employers to adhere to certain housekeeping practices. Paragraphs
(j)(1) and (j)(2) require employers to maintain all surfaces in
beryllium work areas as free as practicable of beryllium, promptly
clean spills and emergency releases of beryllium, and use appropriate
cleaning methods, while paragraph (j)(3) requires employers to take
certain actions when transferring materials that contain at least 0.1
percent beryllium by weight or that are contaminated with beryllium
outside a plant for the purpose of disposal, recycling, or reuse.
Specifically, paragraph (j)(3)(i) requires that, except for intra-plant
transfers, when transferring these materials for any of these purposes
the employer must label the materials in accordance with paragraph
(m)(3). Paragraph (j)(3)(ii) further requires that those materials
designated for disposal must be either cleaned to be as free as
practicable of beryllium or placed in enclosures that prevent the
release of beryllium-containing particulate or solutions under normal
conditions of use, storage, or transport, such as bags or containers.
Paragraph (j)(3)(iii) requires the same for materials designated for
recycling or reuse.
The final rule makes a number of changes to the previous
requirements of paragraph (j)(3). As originally promulgated in the 2017
final rule, paragraph (j)(3)(i) required that materials designated for
disposal be disposed of in sealed, impermeable enclosures, such as bags
or containers, that are labeled according to paragraph (m)(3) of the
beryllium standard, but did not allow employers the alternative option
of cleaning such material to be as free as practicable of beryllium.
Further, both paragraphs (j)(3)(i) and (j)(3)(ii) required that
materials be transferred in sealed, impermeable bags, but did not
further define this requirement. Finally, the original paragraph (j)(3)
did not explicitly address transfers of materials for the purpose of
reuse.\17\
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\17\ Subsequent to the 2017 final rule, the 2018 direct final
rule clarified that the requirements of paragraph (j)(3) do not
apply to materials containing only trace amounts of beryllium (less
than 0.1 percent by weight).
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After the promulgation of the final rule in 2017, OSHA learned that
some stakeholders were confused about these requirements. For example,
stakeholders were uncertain about what types of enclosures would be
acceptable under the standard. To help alleviate stakeholder confusion,
OSHA proposed a number of changes in the 2018 NPRM that make explicit
what had been intended in the 2017 final rulemaking. Specifically, OSHA
proposed adding provisions explicitly addressing transferring materials
for reuse; clarifying that the rule's requirements for disposal,
recycling, and reuse do not apply to intra-plant transfers; and
allowing for the cleaning of materials bound for disposal. The agency
also proposed reorganizing the paragraph's two paragraphs into three
that focused on specific topics and making minor changes in terminology
to improve the clarity and internal consistency of the standard. Only
one of the changes is substantive, which is the inclusion of the option
for cleaning instead of enclosure; the remaining edits merely clarify
OSHA's original intent. As discussed in more detail below, OSHA is
retaining the changes proposed in the 2018 NPRM in the final rule with
only one clarifying revision. With these changes, final paragraph
(j)(3) provides comprehensive, easy to understand requirements for
employers that are transferring materials outside of their plants for
disposal, recycling, or reuse that contain at least 0.1 percent
beryllium by weight or are contaminated with beryllium.
In response to the 2018 NPRM, a number of commenters, including the
DOD, Materion, the USW, and EEI, expressed support for the proposed
revisions generally (see, e.g., Document ID 0029, p. 1; 0038, pp. 32-
33; 0033, p. 5; 0031, p. 2). For example, DOD stated that the revisions
``are evidence based and provide greater employee protection''
(Document ID 0029, p. 1). Similarly, Materion commented that the
revisions ``will provide improved understanding and more practical
meaning to manufacturers by improving the clarity and internal
consistency of the standard'' (Document ID 0038, p. 32).
Stakeholders also offered specific comments on the individual
changes OSHA proposed to paragraph (j)(3). OSHA outlines each of those
changes below, along with any specific comments received on those
changes and the agency's final determination as to whether to retain
the proposed change in the final rule.
OSHA proposed seven changes to the 2017 version of paragraph
(j)(3). First, the agency proposed that the provisions address reuse
(in addition to disposal and recycling). As noted above, paragraph
(j)(3) of the 2017 final rule contained requirements for the labeling
and enclosure of certain materials designated for disposal and the
labeling and either enclosure or cleaning of materials designated for
recycling. The preamble to the 2017 final rule made clear that
paragraph (j)(3)'s requirements related to recycling also applied to
reuse (see 82 FR at 2695-96), but the standard did not explicitly
advise employers of this requirement. To make the agency's original
intent clear, OSHA proposed in the 2018 NPRM to include provisions
addressing reuse. This proposed change was intended to ensure that
workers who may be exposed to materials containing or contaminated with
beryllium that are directly reused without first being processed into a
different form are appropriately protected. For example, a manufacturer
may sell a by-product from a process to a downstream manufacturer that
would reuse the by-product as a component of a new product. Recycling,
on the other hand, typically involves the further processing of waste
materials to separate and recover various components of value. OSHA did
not receive any specific comments on the addition addressing reuse of
materials in paragraph (j)(3). Therefore, OSHA has finalized the
inclusion of requirements related to the reuse of materials in
paragraph (j)(3).
Second, OSHA proposed reorganizing paragraph (j)(3)'s original two
paragraphs (one on disposal, one on recycling--with the labeling
requirements specified in each) into three new paragraphs with each
paragraph focusing on a different topic. Proposed paragraph (j)(3)(i)
spelled out the labeling requirements, proposed paragraph (j)(3)(ii)
included the requirements for cleaning or enclosing materials bound for
disposal, and proposed paragraph (j)(3)(iii) laid out the obligations
as to materials designated for recycling or reuse. The proposed
reorganization allowed the agency to incorporate the new reuse
requirements, while also setting out each distinct obligation clearly.
OSHA further explained in the proposal that this is not a substantive
change to the standard, but rather only a reorganization of the
existing provisions (see 83 FR at 63763). One commenter, Materion,
addressed the reorganization of paragraph (j)(3), noting that the
change would improve the clarity and employers' understanding of the
provisions (Document ID 0038, p. 32). Having received no comments to
the contrary, OSHA is adopting the new structure to paragraph (j)(3) in
the final rule.
Third, OSHA proposed a simplifying change relating to the
description of which materials must be labeled and cleaned or enclosed
prior to transfer for disposal, recycling, or reuse. The 2018 direct
final rule required employers to label and clean or enclose two groups
of materials: (1) Materials that contain beryllium in concentrations of
0.1 percent by weight or more, and (2) materials that are contaminated
with beryllium. In the 2018 NPRM, OSHA proposed a simplifying edit to
the first group of materials. Specifically, the agency proposed
replacing the phrase materials ``that contain beryllium in
concentrations of 0.1 percent by weight or more'' with a shorter
phrase: Materials ``that contain at least 0.1 percent beryllium by
weight.'' As the agency explained in the 2018 NPRM, this change is
meant to simplify the language and does not change the meaning. OSHA
did not receive any comments on the proposed simplification of this
language. Therefore, OSHA is adopting the new phrase ``that contain at
least 0.1 percent beryllium by weight'' in paragraph (j)(3) in the
final rule.
Fourth, OSHA proposed adding an explicit exemption for materials
transferred within a plant from the cleaning and enclosure requirements
in new paragraphs (j)(3)(ii) and (iii). While this exemption was not
explicitly included in the regulatory text of the 2017 final rule, its
inclusion in this final rule is not a substantive change. As OSHA noted
in the 2018 NPRM, the agency never intended the provisions of paragraph
(j)(3) to require employers to clean or enclose materials to be used in
another location within the same facility (83 FR at 63756 (citing 82 FR
at 2696)).\18\ Thus, the inclusion of the exemption in the proposed
regulatory text simply makes the agency's intent plain.
---------------------------------------------------------------------------
\18\ As OSHA noted in the 2018 NPRM, employees who may be
exposed to these materials during intra-plant transfers will not go
unprotected. On the contrary, other provisions of the beryllium
standard require employers to communicate possible hazards to these
employees and protect them during such transfers (see, e.g.,
paragraph (f), Methods of compliance; paragraph (g), Respiratory
protection; paragraph (h), Personal protective clothing and
equipment; paragraph (m), Communication of hazards).
---------------------------------------------------------------------------
The USW supported the proposed inclusion of the ``intra-plant
transfer'' exemption in the regulatory text (Document ID 0033, p. 5).
Specifically, the USW pointed to its comments on OSHA's 2015 NPRM,
which stated that the agency should not require all materials to be
decontaminated or sealed in an enclosure (Document ID 0033, p. 5).
Rather, the USW explained, the initial intent of the corresponding
provision of the model standard it drafted jointly with Materion was
``to ensure that materials leaving a facility and designated for
recycling be containerized or visibly clean'' (Document ID 0033, p. 5)
(emphasis added).
DOD did not submit a comment on the proposed intra-plant transfer
exception, but its comment on another part of paragraph (j)(3)
suggested that it understood the paragraph to apply to intra-plant
transfers (see Document ID
0029, p. 1 (``To support the proposed revisions that require surface
cleaning of equipment and materials to remove beryllium before
recycling, re-use, or intra-plant transfers, we recommend the use of
the Department of Energy's (DOE's) cleanliness standards as specified
in Title 10 Code of Federal Regulations Part 850.'')).\19\ As discussed
below, OSHA does not agree with DOD's suggested use of DOE's surface
limits and, as already stated, OSHA never intended to require employers
to clean or enclose materials transferred within a single plant.
Rather, the provisions in paragraph (j)(3) have always been intended to
protect employees after the materials leave the facility.
---------------------------------------------------------------------------
\19\ DOD's suggestion regarding DOE's cleanliness standards is
addressed below in this section of this final rule as part of the
discussion of the seventh and final proposed change to paragraph
(j)(3) relating to the cleaning of materials designated for
disposal, recycling, or reuse.
---------------------------------------------------------------------------
Materion commented that beryllium-containing scrap metal or wastes
are, in most cases, recycled internally ``either within or between
facilities,'' but companies ``also recycle scrap or purchase scrap on
the open market'' (Document ID 0038, p. 32). Materion further asserted
that OSHA's regulation ``should not be construed as potentially
limiting the environmentally beneficial recycling of metals'' (Document
ID 0038, p. 32). OSHA agrees that paragraph (j)(3)'s requirements
should not be read to discourage the reuse or recycling of metals and
reads Materion's statements regarding the manner in which companies
recycle scrap metal or wastes (i.e., within or between facilities or on
the open market) as purely informational. However, the agency notes
that this comment could be read to suggest that the exception for items
transferred within a facility also applies to items transferred between
two facilities owned by the same employer. Such an interpretation would
be incorrect--the intra-plant transfer exception only exempts transfers
within a single plant; material transfers between plants are not
excluded, regardless of plant ownership.
This comment also alerted the agency to a potential ambiguity in
the text of proposed paragraph (j)(3)(i). Specifically, OSHA realized
that the phrase ``to another party'' could be read to suggest that
transfers between two facilities owned by the same employer are
exempted from the labeling requirements in paragraph (j)(3)(i). Again,
this was not the agency's intent. As noted above, the proposed addition
of the explicit intra-plant transfer exception in paragraphs (j)(3)(ii)
and (iii) was not a substantive change--the agency never intended to
require employers to clean or enclose materials transferred within a
single plant. The reorganization of paragraph (j)(3) was also not a
substantive change; it merely allowed the agency to make clear that the
labeling requirements apply regardless of whether the employer
transfers materials for the purpose of disposal, recycling, or reuse
(83 FR at 63763, 63756). Because the labeling requirements were part of
paragraphs (j)(3)(i) and (ii) in the 2017 final rule, to which the
intra-plant exemption applied, and were simply moved to a new stand-
alone paragraph without substantive change, the scope of those
activities requiring labeling has not changed. Put another way, the
intra-plant exemption continues to apply to the labeling provision to
the same extent it did prior to the proposal. And, more to the point,
the labeling requirement continues to apply to all other transfers for
purposes of disposal, recycling, or reuse, regardless of whether they
involve transfers between two locations operated by the same employer.
If proposed paragraph (j)(3)(i) was interpreted to only require the
labeling of materials transferred to another employer (rather than
another facility), then an employer could place materials that were
designated for reuse in an enclosure and transfer them to another
facility without a label, so long as the employer owned the second
facility. This scheme could potentially put both the transferring and
receiving employees at risk by failing to appropriately apprise them of
the presence of beryllium-containing materials and the hazardous nature
of beryllium exposure.
Moreover, such an interpretation could lead to inconsistencies or
conflicts with the Hazard Communication standard (HCS) (29 CFR
1910.1200), which requires labeling for all hazardous chemicals leaving
a worksite regardless of destination. This is clearly laid out in
OSHA's Hazard Communication directive (CPL 02-02-079): ``Manufacturers,
importers, and distributors are required to ensure that each container
of hazardous chemicals is appropriately labeled. Labeling requirements
apply for shipped containers leaving the workplace regardless of
whether the intended destination is interstate or intrastate.''
Although the agency's intent was always to exempt only intra-plant
transfers from the labeling requirement, OSHA sees value in eliminating
any ambiguity and ensuring that labeling is consistent with the
requirements of the HCS. Therefore, the agency is revising the text of
paragraph (j)(3)(i) to more explicitly match the intent expressed in
both the 2017 rule and the 2018 proposal. Specifically, OSHA is
revising paragraph (j)(3)(i) in the final rule to strike the phrase
``to another party'' and add the ``except for intra-plant transfers''
language that is found in paragraphs (j)(3)(ii) and (iii). Final
paragraph (j)(3)(i), therefore, provides that except for intra-plant
transfers, when the employer transfers materials that contain at least
0.1 percent beryllium by weight or are contaminated with beryllium for
disposal, recycling, or reuse, the employer must label the materials in
accordance with paragraph (m)(3) of this standard.
In summary, OSHA is adopting the proposed addition of the explicit
intra-plant exception in final paragraphs (j)(3)(ii) and (iii). No
commenters opposed these revisions and, therefore, OSHA has decided to
retain them, unchanged from the proposal (see Document ID 0038, p. 32;
0033, p. 5). The agency is also revising proposed paragraph (j)(3)(i)
to explicitly incorporate the exception. As explained in detail above,
none of these changes are substantive, but OSHA expects the clarified
language will aid employers in understanding and, thus, carrying out
their responsibilities under these provisions.
OSHA's fifth proposed change to paragraph (j)(3) focused on the
requirement to place items in ``sealed, impermeable enclosures.''
Specifically, paragraph (j)(3)(i) in the 2017 final rule required
employers to place certain materials bound for disposal in ``sealed,
impermeable enclosures, such as bags or containers.'' Paragraph
(j)(3)(ii) in the 2017 final rule also required enclosure of certain
materials that had not been appropriately cleaned. In the preamble to
the 2017 final rule, OSHA explained that it intended these requirements
to be broad and performance-oriented and clarified that the term
``impermeable'' was not intended to mean absolutely impervious to
rupture but, rather, that the enclosures would not allow materials to
escape under normal conditions of use (82 FR at 2695). Nevertheless,
the agency learned that confusion around the enclosure requirement
remained.
To alleviate the confusion regarding the enclosure requirements,
OSHA proposed in the 2018 NPRM to clarify the ``sealed, impermeable
bag'' requirement to make explicit what had been intended in the 2017
final rulemaking: That employers must utilize enclosures that prevent
the release of beryllium-containing
particulate or solutions under normal conditions of use, storage, or
transport. The agency further explained that the proposed change would
reinforce the requirement that employers select the appropriate type of
container to prevent release based on the form of beryllium and how it
is normally handled. For example, a container that prevents the release
of a beryllium particulate may not be effective in preventing the
release of a beryllium solution.
One commenter, Materion, submitted comments specific to this
proposed change (Document ID 0038, p. 32). Materion was supportive of
the revision, noting that it will significantly improve understanding
of the requirements for containerization and transport of recycled
materials and asserting its belief that without the proposed changes
the disposal and recycling provision are technologically and
economically infeasible (Document ID 0038, p. 32). According to
Materion, the change appropriately accommodates the various physical
properties of beryllium materials being recycled, the ``many different
applications resulting in many types of container configurations,'' and
the ``many types of transfer mechanisms and end use processing
applications'' (Document ID 0038, p. 32). No commenters opposed these
revisions and, therefore, OSHA has decided to retain them unchanged
from the proposal.
Unlike the previous five proposed changes, the sixth proposed
change was more than a clarifying change from the 2017 final rule.
Under the 2017 final rule, employers could either clean or enclose
materials designated for recycling. Materials designated for disposal,
however, could only be enclosed; the option to clean the materials was
not available. The difference in the two provisions stemmed from the
concern that municipal and commercial disposal workers should be
protected from exposure to beryllium from contact with materials
discarded from beryllium work areas in general industry by placing
those materials in enclosed containers. However, as OSHA explained in
the 2018 NPRM, the agency had not considered situations where it would
be impractical to require enclosure because the materials in question
were large items, such as machines or structures, that may contain at
least 0.1 percent beryllium by weight or be contaminated with
beryllium, rather than more common items, such as beryllium scrap metal
or shavings.
With that situation in mind, OSHA reconsidered its earlier
determination and preliminarily determined that workers handling items
designated for disposal, like workers handling items designated for
recycling or reuse, would be just as protected from exposure to
beryllium if the items are cleaned to be as free as practicable of
beryllium as if the items were placed in containers. In accordance with
this preliminary determination, OSHA in the 2018 NPRM proposed adding
the cleaning option to paragraph (j)(3)(ii). The agency explained that,
regardless of whether an employer chooses to clean or enclose materials
designated for disposal, the labeling requirements under proposed
paragraph (j)(3)(i) would apply and would require that the materials
designated for disposal be labeled in accordance with paragraph (m)(3)
of this standard. It further noted its expectation that these proposed
changes would maintain safety and health protections for workers.
OSHA received no comments on this proposed revision and has
therefore finalized it as proposed.
The seventh and final proposed change also relates to the cleaning
of materials designated for disposal, recycling, or reuse. Paragraph
(j)(3)(ii) in the 2017 final rule required the specified materials to
be cleaned to be as free as practicable of surface beryllium
contamination. However, the 2017 final rule did not define the term
``surface beryllium contamination'' and other parts of the 2017 final
rule used the term ``as free as practicable'' without the ``surface
beryllium contamination'' modifier. To alleviate any potential
confusion stemming from the agency's use of this new, undefined term,
OSHA proposed to eliminate any potential confusion by removing the
phrase ``surface beryllium contamination.''
OSHA did not receive any comments that directly addressed the
removal of this phrase but one stakeholder, DOD, offered a suggestion.
Specifically, DOD recommended the use of the Department of Energy's
(DOE's) cleanliness standards as specified in Title 10 Code of Federal
Regulations Part 850 (Document ID 0029, p. 1). According to DOD, these
standards are ``generally-acceptable criteria for surface contamination
and were adopted based on DOE's assessment of practical cleanliness
levels and proven feasibility'' (Document ID 0029, p. 1).
OSHA agrees that DOE's standards might be a useful reference for
employers seeking advice on how to clean materials prior to transfer
for disposal, reuse, or recycling or how to determine the effectiveness
of existing cleaning efforts and that wipe sampling in general can be a
useful tool for employers to provide feedback on their cleaning
procedures. To the extent that DOD's recommendation was intended to
suggest an amendment to the proposed provisions, however, OSHA does not
believe such an amendment is appropriate. As discussed in the 2018
NPRM, the ``as free as practicable'' standard is well-understood by the
regulated community. OSHA has used the phrase in existing substance-
specific standards, including those for lead (29 CFR 1910.1025, 29 CFR
1926.62), chromium (VI) (29 CFR 1910.1026), and asbestos (29 CFR
1910.1001), and has previously discussed its meaning in a 2014 letter
of interpretation explaining the phrase in the context of the chromium
standard (OSHA, Nov. 5, 2014, Letter of Interpretation, available at
https://www.osha.gov/laws-regs/standardinterpretations/2014-11-05).
Additionally, as discussed in the Summary and Explanation of the
definition of the term dermal contact with beryllium, 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. Therefore, the agency has chosen not to require a
specific target level of surface contamination for any of the surface
cleanliness requirements of the beryllium standards. Instead, the
agency has determined that the more performance-oriented ``as free as
practicable'' standard for cleaning--rather than a more prescriptive
requirement--is appropriate. The agency finds that the use of the
broader standard will better serve employees by allowing employers in a
variety of industries flexibility to decide what type of control
methods and procedures are best suited to their beryllium operations.
Having received no other comments on this proposed provision, OSHA
strikes the phrase ``surface beryllium contamination'' from the
regulatory text, as proposed.
In summary, OSHA is finalizing (j)(3) as proposed in 2018, except
for the clarifying revision in paragraph (j)(3)(i), which explicitly
incorporates the intra-plant exception found in paragraphs (j)(3)(ii)
and (j)(3)(iii). OSHA has based this decision on the record and has
determined this will maintain or enhance worker protections.
Medical Surveillance.
Paragraph (k) of the beryllium standard for general industry (29
CFR 1910.1024) addresses medical surveillance requirements. 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 must be provided to the employee and employer. 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 the beryllium standard for general industry 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.
In the 2018 NPRM, OSHA proposed two sets of changes to paragraph
(k). The first set of changes proposed is in paragraph (k)(2), which
specifies when and how frequently medical examinations were to be
offered to those employees covered by the medical surveillance program.
Paragraph (k)(2)(i)(B) of the standard requires the employer to provide
a medical examination within 30 days after determining that the
employee shows signs or symptoms of CBD or other beryllium-related
health effects or that the employee has been exposed to beryllium in an
emergency. After publication of the 2017 final rule, stakeholders
suggested to OSHA that, for individuals exposed one-time during an
emergency, 30 days may be insufficient to detect beryllium
sensitization, so a longer timeframe for medical examinations may be
more appropriate (83 FR at 63757).
In the 2018 NPRM, OSHA acknowledged uncertainty regarding the time
period in which sensitization may occur following a one-time exposure
to a significant concentration of beryllium in an emergency (83 FR at
63757). In fact, beryllium sensitization can occur several months or
more after initial exposure to beryllium among workers with regular
occupational exposure to beryllium (see 83 FR at 63757 (citing 82 FR at
2530, 2533)). Based on this evidence and stakeholder feedback, OSHA
proposed removing the requirement for a medical examination within 30
days of exposure in an emergency, under paragraph (k)(2)(i)(B), and
adding paragraph (k)(2)(iv), which would require the employer to offer
a medical examination at least one year after but no more than two
years after the employee is exposed to beryllium in an emergency. OSHA
requested comments on the appropriateness of this change (83 FR at
63757).
Several stakeholders commented on this issue. NJH supported
extending the time to offer medical surveillance to one year after an
emergency because 30 days following a high exposure may not be enough
time to detect beryllium sensitization (Document ID 0022, p. 8).
Materion also agreed with the proposed one-to-two-year timeframe for
examinations following exposure during an emergency because 30 days may
be too soon to detect an immunological change using the BeLPT (Document
ID 0038, p. 33). DOSH similarly commented that delaying the medical
examination to one year might improve the detection of sensitization
because it may take several months to detect it (Document ID 0023, p.
2). DOSH also expressed concern, however, that workers would not get
counseling about signs and symptoms of beryllium-related conditions, an
occupational history review, and other medical advice which may allow
for the worker to identify a developing condition within the first year
after exposure (Document ID 0023, p. 2). DOSH added that if the medical
examination will be delayed, it would be appropriate to have a
requirement for additional training or a brief medical consultation for
workers who are not knowledgeable about beryllium and the potential
medical conditions that may be triggered by exposure (Document ID 0023,
pp. 2-3).
The ACOEM and NSSP shared DOSH's concerns regarding potential
delays in consultations and counseling (Document ID 0024, p. 2; 0027,
p. 4). The NSSP recommended an earlier discussion with employees
exposed in an emergency to address their individual concerns, the
medical path forward, options available, and to answer any questions
the employees might have (Document ID 0027, p. 4). It suggested that
the medical examination could then be scheduled in keeping with the
individual employee's medical needs (Document ID 0027, p. 4). ACOEM
opposed the change, arguing that workers who are exposed to beryllium
in an emergency deserve prompt medical evaluation to understand the
potential health risks, receive baseline testing, if desired, and to
receive medical counseling (Document ID 0024, p. 2). ACOEM maintained
that it would be ``an extremely insensitive and harsh change in
policy'' to require exposed workers to wait more than a year to receive
professional medical advice (Document ID 0024, p. 2). On the other
hand, Materion argued that the standard protects workers who may have
been exposed in an emergency, regardless of when the emergency
occurred, by requiring employers to make medical surveillance available
to any employees showing signs and symptoms of CBD or other beryllium-
related health effects (Document ID 0038, p. 33). Specifically,
paragraph (k)(2)(i)(B) requires employers to provide an examination to
these employees within 30 days of determining that the employee shows
signs or symptoms of CBD.
After considering these comments and the record as a whole on this
issue, OSHA reaffirms its preliminary belief that testing conducted
during the proposed time period of one to two years is more likely to
detect sensitization than testing conducted 30 days following emergency
exposure (82 FR at 63757). Nevertheless, DOSH, the NSSP, and ACOEM's
concerns about possible delays in medical consultations and
examinations and lack of employee knowledge of potential health effects
prompted the agency to reevaluate the standard's medical surveillance
and training triggers to determine if any employees could potentially
be exposed in an emergency but may not be knowledgeable about symptoms,
health effects, and medical surveillance because they have not been
trained, or if any employees might be exposed but have not recently
received a medical examination during which they had the opportunity to
talk with a PLHCP about exposure to beryllium.
First, OSHA considered the population of employees affected by
emergencies. As noted in the 2018 NPRM, OSHA estimates that a very
small number of employees, likely less than 0.1 percent of the affected
population, would be affected by emergencies in a given year (83 FR at
63764). Second, OSHA considered if any of the small number of employees
exposed in an emergency in a given year would not be knowledgeable
about symptoms, health effects, and medical surveillance through the
training provided under paragraph (m)(4) at the time of emergency and,
thus, might need such training after exposure during an emergency.
Paragraph (m)(4)(i) requires the employer to provide information and
training in accordance with the Hazard Communication Standard (HCS), 29
CFR 1910.1200(h), for each employee who has, or can reasonably be
expected to have, airborne exposure to or dermal contact with
beryllium. Final paragraph (m)(4)(ii) requires employers to ensure that
each
employee who is, or can reasonably be expected to be, exposed to
airborne beryllium can demonstrate knowledge and understanding of a
number of specified topics, including (1) the health hazards associated
with airborne exposure to and dermal contact with beryllium, including
signs and symptoms of CBD; (2) the purpose and a description of the
medical surveillance program under paragraph (k) of the standard,
including risks and benefits of each test to be offered; (3) the
purpose and a description of the medical removal protection provided
under paragraph (l) of the standard; and (4) the contents of the
standard.
OSHA expects that the vast majority of employees who could be
exposed to beryllium in an emergency are those who are regularly
exposed to beryllium as part of their normal work duties performed near
processes involving beryllium. Therefore, most of those employees are
already likely to be trained in accordance with the HCS under paragraph
(m)(4)(i) because the training requirements under paragraph (m)(4)(i)
are triggered by actual, or reasonably anticipated, airborne exposure
at any level or dermal contact with beryllium. In addition, OSHA
anticipates that most of these employees would also be knowledgeable
about beryllium-related health effects, medical surveillance, medical
removal, and the remainder of the standard, as required by paragraph
(m)(4)(ii). Nevertheless, if an employee who had not been trained in
accordance with paragraph (m)(4) or was not knowledgeable of the
subjects covered in paragraph (m)(4)(ii) was exposed in an emergency,
the standard would require that the employee be trained after the
emergency because the exposure during the emergency would cause them to
meet the standard's training triggers. In other words, the standard
already provides for training of the very small number of untrained or
unknowledgeable employees who might be exposed during an emergency.\20\
---------------------------------------------------------------------------
\20\ OSHA notes that the standard would require additional
training for workers who were exposed during an emergency who had
already been trained if the employer realized that those workers
were not knowledgeable about topics such as the potential medical
conditions which may result from exposure to beryllium or symptoms
that may trigger a medical examination (see paragraph (m)(4)(ii)(A);
see also additional training requirements under paragraph
(m)(4)(iii)).
---------------------------------------------------------------------------
Third, OSHA considered if any employees exposed during an emergency
would likely not have received a recent examination under the standard.
Under paragraph (k)(1)(i), the employer must make medical surveillance
available to four groups of employees: (A) Employees who are or are
reasonably expected to be exposed at or above the action level for more
than 30 days per year, (B) employees who show signs or symptoms of CBD
or other beryllium-related health effects, (C) employees who are
exposed to beryllium during an emergency, and (D) employees whose most
recent written medical surveillance opinion required by paragraph
(k)(6) or (k)(7) of the standard recommends periodic medical
surveillance. Under paragraph (k)(2)(ii), employees who continue to
meet above-triggers (A), (B), or (D) of the standard receive
examinations at least every two years after their most recent
examination. Employees previously exposed in an emergency (and all
other employees who have received an examination, but no longer meet
the criteria for periodic examinations) continue to be offered a
standardized BeLPT or equivalent test at least every two years, unless
they are confirmed positive (paragraph (k)(3)(i)(E); 82 FR at 2705).
As noted above, OSHA expects that the vast majority of employees
who could be exposed to beryllium in an emergency are those who are
regularly exposed to beryllium as part of their normal work duties that
are performed near processes involving beryllium. As a result, OSHA
expects that the majority of employees who could be exposed to
beryllium in an emergency are likely to be those who meet the trigger
for periodic medical surveillance under paragraph (k)(1)(i)(A) (i.e.,
they are or are reasonably expected to be exposed at or above the
action level for more than 30 days per year). Thus, they have likely
had an opportunity to consult with a PLHCP at a minimum of every two
years (paragraph (k)(2)(ii)). Other employees exposed during an
emergency may have also had a recent examination because they have
recently met one of the other triggers, such as experiencing signs or
symptoms of CBD or other beryllium-related health effects. OSHA
recognizes, however, that a much smaller number of employees, such as
office and warehouse workers, who do not have regular exposures to
beryllium at or above the action level and have also not met one of the
other medical surveillance triggers, could potentially be exposed to
beryllium in an emergency. These employees may have never received a
medical examination or a BeLPT or equivalent test.
OSHA agrees with ACOEM that it is unacceptable to have employees
who have not recently been offered a medical examination under the
beryllium standard wait for a year or more for a medical consultation
and examination after exposure during an emergency. These employees may
not have baseline information on their health status, and they may not
have had the opportunity to speak to a PLHCP to ask questions related
to their concerns, such as possible health risks, symptoms, and medical
interventions. In contrast, employees who had a medical examination
within the previous two years would have a baseline and have had the
opportunity to speak with a health professional. Therefore, to
adequately meet the needs of all employees who may be exposed in an
emergency, OSHA is deleting final paragraph (k)(2)(iv) and replacing it
with paragraphs (k)(2)(iv)(A) and (k)(2)(iv)(B).
New paragraph (k)(2)(iv)(A) addresses the needs of the very small
group of employees who are exposed in an emergency but have not
received a medical examination under paragraph (k)(1)(i) within the
previous two years. Specifically, paragraph (k)(2)(iv)(A) requires that
if an employee is exposed to beryllium during an emergency and has not
received a medical examination under paragraph (k)(1)(i) within the
previous two years, then the employer must provide that employee with a
medical examination within 30 days of the date of the emergency. New
paragraph (k)(2)(iv)(B), on the other hand, focuses on employees who
are exposed during an emergency, but have recently received an
examination. Under paragraph (k)(2)(iv)(B), if an employee has received
a medical examination under paragraph (k)(1)(i) within the previous two
years, then the employer would be required to offer that employee a
medical examination that meets the requirements of the standard at
least one year but no more than two years after the employee was
exposed to beryllium in an emergency.
OSHA concludes that it is appropriate to provide a medical
examination within 30 days after the employee was exposed in an
emergency, if the employee has not had an examination under the
beryllium standard within the last two years. It addresses the concerns
of DOSH, ACOEM, and the NSSP that employees receive timely medical
consultations and evaluations. If an employee has not had a previous
examination under the standard, the examination at 30 days after the
emergency allows for collection of baseline values on health status, as
recommended by ACOEM. Baseline information about the employee's current
health status, such as lung function, will allow for a comparison with
changes that might occur in the future. Moreover, if the employee is
confirmed positive by the baseline
BeLPT and there is a possibility that the employee could be exposed to
beryllium again in the future, knowledge about the confirmed positive
finding would allow the employee to consider risks and options related
to employment (82 FR at 2702).
OSHA recognizes, as NJH, DOSH, and Materion noted, that 30 days
following the emergency is not the best timeframe for detecting
sensitization. However, paragraph (k)(3)(ii)(E) of the beryllium
standard for general industry already requires that employees who
received a medical examination because of an emergency exposure
continue to receive a BeLPT, or an equivalent test, every two years
following that examination, unless the employee is confirmed positive.
Therefore, the standard already requires the employers to offer these
employees a BeLPT for the remainder of their tenure in the workplace
where they were exposed in an emergency, rather than limiting the
opportunity to detect sensitization to 30 days following the emergency.
OSHA also concludes that it is appropriate to require employers to
offer medical surveillance within one to two years after exposure to
beryllium in an emergency, if that employee had an examination that
meets the requirements of the beryllium standard within the last two
years. These employees could include those who undergo periodic medical
surveillance at least every two years under paragraph (k)(2)(A) or (D),
or who may have received a medical examination within the last two
years because they were experiencing symptoms or were exposed in a
previous emergency (paragraphs (k)(2)(B) and (C)). These employees
would have received a recent medical consultation and examination which
would have allowed them to ask questions. In addition, these employees
would have received a baseline examination. Like the employees examined
within 30 days after exposure to beryllium in an emergency, all these
employees examined within one to two years of the emergency will
continue to be offered BeLPT testing every two years under paragraph
(k)(3)(ii)(E) if they have not been confirmed positive and do not or no
longer meet the criteria for full periodic medical examinations under
paragraph (k)(2)(ii).
The requirement for continuing BeLPTs for any employee who has
received an examination under the beryllium standard, including for an
emergency exposure, addresses another concern voiced by NJH, which is
that anyone exposed in an emergency should be provided periodic medical
surveillance (Document ID 0022, p. 8). If the employee is confirmed
positive, or if the licensed physician otherwise deems it appropriate,
the licensed physician is to provide in the written medical opinion to
the employee a referral to a CBD diagnostic center and a recommendation
for continued periodic medical surveillance under paragraph (k)(5)(iii)
and (iv). If the employee authorizes the recommendation for referral to
be included in the written opinion, the employer must provide an
examination at a CBD diagnostic center (discussed in more detail below)
(paragraph (k)(6)(iii)). Once an employee is evaluated at a CBD
diagnostic center, as described under paragraph (k)(7)(i), the employee
may choose to have any subsequent medical examinations for which the
employee is eligible, performed at the CBD diagnostic center at no cost
to the employee (see final paragraph (k)(7)(vi)). Therefore, the
standard already allows for periodic BeLPT testing for all employees
exposed in an emergency, and periodic medical surveillance for any of
those employees who are confirmed positive.
Another concern that was raised by DOSH is that delaying the
medical examination to at least one year following the emergency may
result in employees not receiving the examination if their employment
ends within that one-year period (Document ID 0023, p. 3). This concern
continues to be relevant to employees who are receiving the examination
for an emergency exposure at one to two years after the exposure in the
emergency (paragraph (k)(2)(iv)(B)). If employment does end before one
year after the emergency, paragraphs (k)(2)(iii) and (1)(i)(C) require
the employer to offer a medical examination at termination of
employment to any employee exposed to beryllium in an emergency, unless
the employee received an examination in accordance with the standard
within the last 6 months. OSHA is concerned that this provision would
not require employers to offer a medical examination to some employees
who would receive the emergency examination at one to two years after
the emergency exposure. For example, if such an employee, already under
medical surveillance, received a medical examination one month before
the emergency and then terminated employment two months after the
emergency, the employer would not be required to offer a medical
examination to that employee exposed during the emergency under the
proposed changes, and the employee would not have an opportunity to
have an medical exam that could detect any adverse effects that might
have occurred because of the emergency. OSHA agrees with DOSH that
further revision is necessary to ensure that every employee who is
exposed in an emergency receives an examination following the
emergency.
Accordingly, OSHA is revising paragraph (k)(2)(iii) to require that
each employee who is exposed in an emergency and has not received an
examination since the emergency exposure is provided an examination at
the time employment is terminated. OSHA finds that this change better
protects employees because it allows health effects that could have
resulted from the emergency exposure to be more readily detected.
In making these decisions on the appropriate timing for medical
examinations for employees exposed to beryllium during an emergency,
OSHA considered Materion's point that employees experiencing signs or
symptoms or other beryllium-related health effects after an emergency
can ask for an examination under paragraph (k)(1)(i)(B) (Document ID
0038, p. 33). As explained above, all employees who are exposed in an
emergency will either have previously received training under paragraph
(m)(4) or will need to be trained within a reasonable time after
exposure. And these employees should already be knowledgeable or will
soon become knowledgeable about the health hazards associated with
airborne exposure to and dermal contact with beryllium, including signs
and symptoms of CBD, as required by paragraph (m)(4)(ii). Therefore,
all employees exposed during an emergency should be able to identify
and report signs or symptoms of CBD or other beryllium-related health
effects either at the time of the emergency or within a reasonable time
after it. Materion is, thus, correct in pointing out that if these
employees did experience such signs or symptoms, they could ask for a
medical examination. Other employees exposed during an emergency that
have not had an examination and do not experience these health effects,
however, would still not have had the opportunity for a timely
consultation and medical examination with a PLHCP. Consequently, OSHA
does not find that the signs-or-symptoms trigger is sufficient to
resolve the concerns raised by the other stakeholders.
OSHA also proposed one additional change to the paragraph involving
emergency exposure. As promulgated in the 2017 final rule, paragraph
(k)(2)(i)(B) required the employer to provide a medical examination
within 30 days
after the employer determines that an employee shows signs or symptoms
of CBD or other beryllium-related health effects or has been exposed to
beryllium in an emergency. Because OSHA believes that employers
typically will learn of any emergency resulting in exposure immediately
or soon after it occurs, OSHA preliminarily determined that it is
appropriate to measure the time period from the date of exposure.
Therefore, under proposed paragraph (k)(2)(iv), the time period for
providing a medical examination begins to run from the date the
employee is exposed during an emergency, regardless of when the
employer discovers that the exposure occurred. OSHA requested comments
on the appropriateness of calculating the time period for a medical
examination from the occurrence of the emergency rather than from the
employer's determination of eligibility.
Materion agreed with OSHA that most employers will learn about the
emergency resulting in exposure immediately or soon after the
occurrence, and it supported measuring the time period from the date of
the exposure, provided that the employer determined that the incident
can be defined as an emergency under the standard (Document ID 0038,
pp. 33-34). OSHA did not receive any comments objecting to OSHA's
proposal to measure the time period from the date of exposure in an
emergency; therefore, OSHA is retaining the proposed language to
measure the time period from the date of the exposure in the emergency
in final paragraphs (k)(2)(iv)(A) and (B).
Paragraph (k)(2)(iv)(B) does not preclude employers from
voluntarily providing a medical examination within the first year after
an emergency. Providing a medical examination sooner would not,
however, relieve an employer of the duty to provide an exam in the one-
to-two-year window. For those employees who are already eligible for
periodic medical surveillance, the examination for the emergency
exposure could be scheduled to coincide with the next periodic
examination that is within two years of the last periodic medical
examination and at least one but no more than two years after the
emergency exposure, satisfying the requirements of both paragraphs
(k)(2)(ii) and (iv)(B).
In summary, OSHA is modifying proposed paragraph (k)(2)(iv) to
customize protections for two general groups of employees who could be
exposed to beryllium in an emergency. Paragraph (k)(2)(iv)(A) will
require the employer to offer a medical examination to an employee
within 30 days after the employee was exposed to beryllium in an
emergency, if the employee has not had an examination under paragraph
(k)(1)(i) within the last two years. This requirement improves
protections for what is likely to be a very small group of employees
who have not had a medical examination under the beryllium standard
within the last two years because it allows those employees to have a
timely consultation and examination. Paragraph (k)(2)(iv)(B) will
require the employer to offer a medical examination to an employee
within one to two years after the employee was exposed to beryllium in
an emergency, if the employee had an examination under paragraph
(k)(1)(i) of the beryllium standard within the last two years. This
provision eliminates the requirement to offer an examination within 30
days to the majority of employees who are likely to be exposed in an
emergency and have already received a recent medical examination. Thus,
these employees would have received a baseline examination and a recent
consultation regarding beryllium. And either group will continue to be
offered the BeLPT, or an equivalent test, every two years under
paragraph (k)(3)(ii)(E), even if they do not or no longer meet the
criteria for full periodic medical examinations under paragraph
(k)(ii). OSHA is also revising paragraph (k)(2)(iii) to require that
employers offer a medical examination to any employee who has not
received an examination since the emergency exposure at the time the
employee's employment is terminated. Again, OSHA expects this to be a
very small group of employees that would have had an exam within six
months of termination but not have had an exam since exposure during an
emergency. This change ensures that all employees exposed in an
emergency receive a medical examination for the emergency exposure
before their employment is terminated.
In addition, other provisions in the standard ensure that either
group of employees (i.e., those who receive a medical examination
within 30 days or one to two years after an emergency) are
knowledgeable about the signs and symptoms of CBD and that if employees
are experiencing signs and symptoms, they will be provided a medical
examination within 30 days of the employer determining that they are
experiencing such signs or symptoms.
The second (and final) set of changes that OSHA proposed to the
standard's medical surveillance requirements is in paragraph (k)(7),
which contains the requirements for evaluation at a CBD diagnostic
center. In this final rule, OSHA is amending paragraph (k)(7) in three
ways. First, OSHA is revising paragraph (k)(7)(i) to require that the
evaluation must be scheduled within 30 days, and must occur within a
reasonable time, of the employer receiving one of the types of
documentation listed in paragraph (k)(7)(i)(A) or (B). Second, OSHA is
adding a provision, in paragraph (k)(7)(ii), which clarifies that, as
part of the evaluation at the CBD diagnostic center, the employer must
ensure that the employee is offered any tests deemed appropriate by the
examining physician at the CBD diagnostic center, such as pulmonary
function testing (as outlined by the American Thoracic Society
criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. The
new provision also states that if any of the tests deemed appropriate
by the examining physician are not available at the CBD diagnostic
center, they may be performed at another location that is mutually
agreed upon by the employer and the employee. Third, OSHA is making a
handful of minor, non-substantive numbering and reference edits to
other provisions in paragraph (k)(7) to account for the addition of new
paragraph (k)(7)(ii). Specifically, OSHA is renumbering current
paragraphs (k)(7)(ii), (iii), (iv), and (v) as (k)(7)(iii), (iv), (v),
and (vi), respectively, and is adding a reference to new paragraph
(k)(7)(ii) to the newly renumbered paragraph (k)(7)(vi).
Each of these final revisions differ in some way from the proposed
amendments based on stakeholder feedback. With regard to the first
change concerning the timing of the exam, the current standard requires
employers to provide the examination within 30 days of the employer
receiving one of the types of documentation listed in paragraph
(k)(7)(i)(A) or (B). The purpose of the 30-day requirement was to
ensure that employees receive the examination in a timely manner. As
OSHA explained in the proposal, however, since the publication of the
2017 final rule stakeholders have raised concerns that the examination
and any required tests could not be scheduled and completed within 30
days (83 FR at 63758).
To address this concern, OSHA proposed that the employer provide an
initial consultation with the CBD diagnostic center, which could occur
via telephone or virtual conferencing methods, rather than the full
evaluation, within 30 days of the employer receiving one of the types
of documentation listed in paragraph (k)(7)(i)(A) or (B). OSHA
explained that providing a consultation before the full examination at
the CBD diagnostic
center would demonstrate that the employer made an effort to begin the
process for a medical examination. OSHA also noted that the proposed
change would also allow (1) the employee to consult with a physician to
discuss concerns and ask questions while waiting for a medical
examination, and (2) the physician to explain the types of tests that
are recommended based on medical findings about the employee and the
risks and benefits of undergoing such testing. OSHA requested comments
on the appropriateness of providing the consultation within 30 days and
on the sufficiency of a consultation via telephone or virtual
conference (83 FR at 63758).
Several stakeholders offered comments on this issue (Document ID
0021, p. 3; 0022, p. 6; 0029, p. 2; 0038, p. 34). The ATS, NJH, and
Materion agreed that an examination at the CBD diagnostic center should
not be required to occur within 30 days of the referral because it may
take weeks or months before the CBD diagnostic center has an opening
for an evaluation. In addition, many of the stakeholders noted that
work responsibilities, personal and family obligations, or the need to
arrange travel may make it difficult for employees to have an
evaluation done within that time period.
Materion also supported the proposed requirement for a telephone or
virtual consultation within 30 days, claiming that it is a more
workable solution that does not reduce protections, while allowing
employees to consider medical options available under the standard and
offering the employee more flexibility in determining when they can
undergo testing based on their availability and preference (Document ID
0038, p. 34). In contrast to Materion, the ATS and NJH opposed the
proposed requirement for a consultation that can be performed via
telephone or virtual conferencing within 30 days of the employer
receiving documentation recommending a referral. NJH commented that a
video or phone consultation would add cost and logistical difficulty to
scheduling, and that it is not necessary because the PLHCP who sees the
employee for screening provides information on the clinical evaluation.
Furthermore, they commented, there are HIPAA privacy issues of a phone
or video conference to consider (Document ID 0022, p. 6).
The ATS agreed with many of the concerns expressed by NJH,
including concerns regarding logistical challenges, the need for an in-
person clinical evaluation and review of medical tests to provide
effective care, and redundancy with the PLHCP consultation (Document ID
0021, p. 3). The ATS and NJH recommended that the standard be revised
to require that the employer make an appointment for the employee to be
evaluated at the CBD diagnostic center within 30 days of receiving
documentation for the referral (Document ID 0021, p. 3; 0022, p. 6).
DOD also opposed requiring an evaluation by telephone or virtual
conferencing and stated that an ill worker should be examined
immediately; it recommended that the employer make the appointment for
evaluation at a CBD diagnostic center within seven days of receiving
documentation for a referral (Document ID 0029, p. 2).
After considering these comments, OSHA is convinced that scheduling
a phone or virtual consultation with the CBD diagnostic center is an
unnecessary step that adds logistical complications and costs. Although
the agency understands Materion's point that the additional
consultation could provide employees with more time and information to
make medical decisions, as well as accommodate other scheduling
logistics, OSHA finds that the scheduling approach suggested by the ATS
and NJH addresses both the logistical difficulties cited by
stakeholders with respect to the requirements in the current standard
and the timing concerns Materion raised. Moreover, OSHA finds that
employees will have enough information (through trainings under
paragraph (m) and discussions with the PLHCP) to allow them to decide
whether to be evaluated at the CBD diagnostic center.\21\ OSHA is
therefore amending paragraph (k)(7)(i) to require that the employer
schedule an examination at a CBD diagnostic center within 30 days of
receiving one of the types of documentation listed in paragraph
(k)(7)(i)(A) or (B). And to maintain the intent of the 2017 final rule
and the 2018 NPRM that evaluation at a CBD diagnostic center occurs in
a timely manner, OSHA is adding that the evaluation must occur within a
reasonable time. Requiring that the evaluation occur within a
reasonable time ensures that the evaluation is done as soon as
practicable based upon availability of openings at the CBD diagnostic
center and the employee's preferences. This revision better addresses
OSHA's original intent that the employee be examined within a timely
period, while providing employees and employers with maximum
flexibility and convenience.
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\21\ Under paragraph (k)(6)(i)(D), the employer is to ensure
that the PLHCP explains the results of the medical examination to
the employee, including results of tests conducted and medical
conditions related to airborne beryllium exposure that require
further evaluation or treatment.
---------------------------------------------------------------------------
Although OSHA understands DOD's concerns about making a timely
appointment, requiring that an appointment be made within a seven-day
period might not give the employee enough time to consider his or her
future obligations and possibly have discussions with family members to
determine the best time period for the examination. OSHA believes that
a 30-day period to schedule an appointment for an examination is a
reasonable time that allows the employee to consider his or her
preferences for an examination date. In addition, a 30-day period
offers more administrative convenience for employers because it is
consistent with other triggers in the beryllium standard.
The second change that OSHA proposed to paragraph (k)(7)(i) relates
to the contents of the examination at the CBD diagnostic center. As
discussed in more detail above, the former definition of CBD diagnostic
center--which stated that the evaluation at the diagnostic center
``must include'' a pulmonary function test as outlined by American
Thoracic Society criteria, bronchoalveolar lavage (BAL), and
transbronchial biopsy--could have been misinterpreted to mean that the
examining physician was required to perform each of these tests during
every clinical evaluation at a CBD diagnostic center. That was not
OSHA's intent. Rather, the agency merely intended to ensure that any
CBD diagnostic center has the capacity to perform any of these tests,
which are commonly needed to diagnose CBD. Therefore, OSHA proposed
revising the definition to clarify that the CBD diagnostic center must
simply have the ability to perform each of these tests when deemed
appropriate.
To account for that proposed change to the definition of CBD
diagnostic center and to ensure that the employer provides those tests
if deemed appropriate by the examining physician at the CBD diagnostic
center, OSHA proposed expanding paragraph (k)(7)(i) to require that the
employer provide, at no cost to the employee and within a reasonable
time after consultation with the CBD diagnostic center, any of the
three tests mentioned above, if deemed appropriate by the examining
physician at the CBD diagnostic center (83 FR at 63764). OSHA explained
that the revision would also clarify the agency's original intent that,
instead of requiring all three tests to be conducted after referral to
a CBD diagnostic center, the standard would allow the examining
physician at the CBD diagnostic center the discretion to select one or
more of those tests as appropriate (83 FR at 63764).
Several stakeholders offered opinions on these proposed changes.
For example, Materion agreed with the proposed changes to align
paragraph (k)(7)(i) with the definition for CBD diagnostic center
(Document ID 0038, p. 34). However, as discussed above in the Summary
and Explanation of paragraph (b), Definitions, the ATS argued that
``not requiring certain diagnostic tests (or an equivalent) could
reduce the potential to diagnose CBD and determine disease severity''
(Document ID 0021, p. 3). The ATS further asserted that ``confirmed
positive workers should have an assessment of lung function and gas
exchange (such as a full set of pulmonary function tests with
spirometry, lung volumes and diffusion capacity for carbon monoxide or
other similar tests) and also chest imaging'' (Document ID 0021, p. 3).
NJH and the AOEC expressed similar concerns, commenting that lung
function and imaging tests should be included as part of an evaluation
at the CBD diagnostic center (Document ID 0022, p. 3; 0028, p. 2).
After reviewing these comments and the remainder of the record on this
issue, OSHA agrees that pulmonary function testing, BAL, and
transbronchial biopsies are important diagnostic tools, but finds that
the examining physician at the CBD diagnostic center is in the best
position to determine which diagnostic tests are appropriate for
particular workers. The agency believes that the modified definition of
the term CBD diagnostic center, which requires the centers to have the
capacity to perform these three tests, will serve to ensure that
healthcare providers at the centers are aware of the importance of and
are able to perform pulmonary function testing, BAL, and transbronchial
biopsies.
Nevertheless, OSHA understands that the proposed provision could be
misinterpreted to mean that the employer does not have to make
available additional tests that the examining physician deems
appropriate for diagnosing or determining severity of CBD. That was
never the agency's intent. In fact, OSHA noted the potential for other
tests, as deemed necessary by the CBD diagnostic center physician,
several times in the preamble to the 2017 final rule (see, e.g., 82 FR
at 2709, 2714). Similar to paragraph (k)(3)(ii)(G), which requires the
employer to ensure that the employee is offered as part of the initial
or periodic medical examination any test deemed appropriate by the
PLHCP, OSHA intends for the employer to ensure the employee is offered
any tests deemed appropriate by the examining physician at the CBD
diagnostic center, including tests for diagnosing CBD, for determining
its severity, and for monitoring progression of CBD following
diagnosis. Allowing the physician at the CBD diagnostic center to order
additional tests that are deemed appropriate is also consistent with
most OSHA substance-specific standards, such as respirable crystalline
silica (29 CFR 1910.1053) and chromium (VI) (29 CFR 1910.1026).
To clarify the agency's intent that the physician at the CBD
diagnostic center has discretion to order appropriate tests, and to
further respond to stakeholder concerns regarding the necessity of
pulmonary function testing, BAL, and transbronchial biopsies, OSHA is
adding a new sub-paragraph (k)(7)(ii), which focuses on the content of
the examination. This new provision requires the employer to ensure
that, as part of the evaluation, the employee is offered any tests
deemed appropriate by the examining physician at the CBD diagnostic
center, such as pulmonary function testing (as outlined by the American
Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy. OSHA intends for the new provision to make clear
that the employer must provide additional tests, such as those noted by
the ATS, NJH, and the AOEC, at no cost to the employee, if those tests
are deemed necessary by the examining physician. The agency also
believes that explicitly naming the three examples of tests that may be
appropriate will further emphasize their importance to examining
physicians at the CBD diagnostic centers.
Consistent with OSHA's original intent, those tests are required to
be offered only if deemed appropriate by the physician at the CBD
diagnostic center. For example, if lung volume and diffusion tests were
performed according to the ATS criteria as part of the periodic medical
examination under paragraph (k)(3) and the physician at the CBD
diagnostic center found them to be of acceptable quality, those tests
would not have to be repeated as part of a CBD evaluation. The addition
of paragraph (k)(7)(ii) clarifies that the employer must, however,
offer any test that the PLHCP deems appropriate. Consistent with
previous health standards and the meaning of the identical phrase in
paragraph (k)(3)(ii)(G), OSHA intends the phrase ``deemed appropriate''
to mean that additional tests requested by the physician must be both
related to beryllium exposure and medically necessary, based on the
findings of the medical examination (see 82 FR at 2709; 81 FR 16286,
16826 (March 25, 2016)).
New paragraph (k)(7)(ii) also addresses the possibility that a test
that is deemed appropriate by the examining physician at the CBD
diagnostic center might not be available at that center. Although
OSHA's intention has been to require any testing to be provided by the
same CBD diagnostic center unless the employer and employee agree to a
different CBD diagnostic center (see 83 FR at 63758), there may be
cases where the CBD diagnostic center does not perform a type of test
deemed appropriate by the examining physician. In such a case, OSHA
wants to ensure that the employee can receive the appropriate test.
Therefore, OSHA is also including in paragraph (k)(7)(ii) a requirement
that if any of those tests deemed appropriate by the physician are not
available at the CBD diagnostic center, they may be performed at
another location that is mutually agreed upon by the employer and the
employee. This other location does not need to be a CBD diagnostic
center as long as it is able to perform tests according to requirements
under paragraph (k). OSHA believes that such circumstances would be
very rare because CBD diagnostic centers with the ability to perform
pulmonary function testing (as outlined by the ATS criteria), BAL, and
transbronchial biopsy are likely to also provide other medical tests
related to CBD.\22\ As a result, the CBD diagnostic center in the vast
majority of cases will be able to offer the additional testing deemed
necessary by the examining physician. Given that this standard requires
CBD diagnostic centers to be able to perform the three most common
tests for diagnosing CBD, and CBD diagnostic centers typically would be
able to offer any additional tests deemed necessary, OSHA expects that
employees would rarely, if ever, need to travel to a second location.
---------------------------------------------------------------------------
\22\ Document ID OSHA-H005C-2006-0870-0637 provides information
from the NJH website, which provides an overview of the types of
tests performed.
---------------------------------------------------------------------------
In summary, final paragraph (k)(7)(i) requires that the employer
provide an evaluation at no cost to the employee at a CBD diagnostic
center that is mutually agreed to by the employer and the employee. The
evaluation must be scheduled within 30 days and must occur within a
reasonable time of the employer receiving one of the types of
documentation listed in paragraph (k)(7)(i)(A) or (B). Final paragraph
(k)(7)(ii) requires the employer to ensure that, as part of the
evaluation, the
employee is offered any tests deemed appropriate by the examining
physician at the CBD diagnostic center, such as pulmonary function
testing (as outlined by the American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and transbronchial biopsy. Paragraph
(k)(7)(ii) further provides that any test deemed appropriate by the
examining physician that is not available at the CBD diagnostic center
may be performed at another location that is agreed upon by the
employer and employee. Such tests must be provided at no cost to the
employee, whether performed at the CBD diagnostic center or at another
location.
As noted above, OSHA is also making a handful of minor, non-
substantive numbering and reference edits to other provisions in
paragraph (k)(7) to account for the addition of new paragraph
(k)(7)(ii). Specifically, OSHA is renumbering current paragraphs
(k)(7)(ii)-(v) as (k)(7)(iii), (iv), (v), and (vi), accordingly, and is
adding a reference to new paragraph (k)(7)(ii) to the newly renumbered
paragraph (k)(7)(vi). Paragraph (k)(7)(vi) provided that after an
employee received the initial clinical evaluation at the CBD diagnostic
center described in paragraph (k)(7)(i), the employee could choose to
have any subsequent medical evaluations for which the employee is
eligible under paragraph (k) performed at a CBD diagnostic center
mutually agreed upon by the employer and employee and that the employer
must provide such examinations to the employee at no cost. OSHA is
revising the paragraph to add the reference to new paragraph (k)(7)(ii)
because the description of the initial clinical evaluation is now split
between paragraph (k)(7)(i) and (ii), rather than appearing solely in
paragraph (k)(7)(i). OSHA does not expect that this clarifying change
will have any substantive effect. Newly renumbered paragraph (k)(7)(vi)
(previous paragraph (k)(7)(v)), therefore, continues to require that,
after an employee has received the initial clinical evaluation at a CBD
diagnostic center, 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.
The addition of paragraph (k)(7)(ii) and consequential renumbering
of current paragraphs (k)(7)(ii)-(v) as (k)(7)(iii), (iv), (v), and
(vi) also affects two other cross-references in the standard. Paragraph
(l)(1) of the standard details the eligibility requirements for medical
removal. Two of the criteria, those in (l)(1)(i)(B) and (l)(1)(ii)
reference paragraphs (k)(7)(ii) and (k)(7)(iii), respectively. In this
final rule, OSHA is updating those references to reflect the
renumbering in paragraph (k)(7). Therefore, final paragraph
(l)(1)(i)(B) references paragraph (k)(7)(iii) and paragraph (l)(1)(ii)
references paragraph (k)(7)(iv). These edits, like those noted above in
paragraph (k)(7)(vi), do not change the substantive meaning of the
provisions.
Communication of Hazards.
Paragraph (m) of the beryllium standard for general industry (29
CFR 1910.1024(m)) sets forth the employer's obligation to comply with
the 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. Under the HCS, beryllium manufacturers
and importers are required to evaluate the hazards of beryllium and
prepare labels and safety data sheets (SDSs) and provide both documents
to downstream users. Employers whose employees are exposed to beryllium
in their workplace must develop a hazard communication program and
ensure that employees are trained on the hazards of beryllium. These
employers must also ensure that all containers of beryllium are labeled
and that employees are provided access to the SDSs. In addition to the
requirements under the HCS, paragraph (m)(1)(ii) of the beryllium
standard for general industry specifies certain criteria that must be
addressed in classifying the hazards of beryllium. Paragraph (m)(2)
requires employers to provide and display warning signs with specified
wording at each approach to a regulated area. Paragraph (m)(3) requires
employers to label each container of clothing, equipment, and materials
contaminated with beryllium using specified language. Finally,
paragraph (m)(4) details employers' duties to provide information and
training to employees.
In the 2018 NPRM, OSHA proposed three revisions to paragraph (m) of
the beryllium standard for general industry (83 FR at 63759-60, 63769).
The first change is related to paragraph (m)(3), which previously
required employers to label ``each bag and container'' of clothing,
equipment, and materials contaminated with beryllium. In the 2018 NPRM,
OSHA proposed to replace the phrase ``each bag and container'' with the
phrase ``each immediate container,'' to clarify that the employer need
only label the immediate bag or container of beryllium-contaminated
items and not larger containers holding the labeled bag or container.
OSHA proposed this change to be consistent with the HCS, which requires
only the primary or immediate container to be labeled (see 29 CFR
1910.1200(c)) (definition of ``Label''). OSHA explained that this
proposed change would effectuate OSHA's intent, expressed in the 2017
final rule, that the hazard communication requirements of the beryllium
standard ``be substantively as consistent as possible'' with the HCS
(82 FR at 2694, 2724). As such, OSHA preliminarily determined that the
change would maintain safety and health protections for workers.
Next, OSHA proposed two revisions to paragraph (m)(4), which
addresses employee information and training. Paragraph (m)(4)(ii)
requires the employer to ensure that each employee who is, or can
reasonably be expected to be, exposed to airborne beryllium can
demonstrate knowledge and understanding of certain specified topics.
One of the topics specified in the previous standard was the health
hazards associated with ``airborne exposure to and contact with
beryllium,'' including the signs and symptoms of CBD (83 FR at 63759).
OSHA proposed to modify this language by adding the word ``dermal''
immediately prior to ``contact with beryllium.'' OSHA explained that
the change would clarify OSHA's intent that employers must ensure that
exposed employees can demonstrate knowledge and understanding of the
health hazards caused by dermal contact with beryllium.
OSHA also proposed to modify the language in paragraph
(m)(4)(ii)(E), which required the employer to ensure that each employee
who is, or can reasonably be expected to be, exposed to airborne
beryllium can demonstrate knowledge and understanding of measures
employees can take to protect themselves from ``airborne exposure to
and contact with beryllium,'' including personal hygiene practices (83
FR at 63759). As with the previous revision, OSHA proposed adding the
word ``dermal'' to ``contact with beryllium'' to clarify OSHA's intent
that employers must ensure exposed employees can demonstrate knowledge
and understanding of measures employees can take to protect themselves
from dermal contact with beryllium.
Commenters did not object to any of the changes that OSHA proposed
to paragraph (m). In fact, the only stakeholder that offered any
comments on these revisions, Materion, generally supported the proposed
changes,
commenting that the changes will maintain safety and health protections
for employees (Document ID 0038, p. 34). OSHA agrees with this
assessment and finds that the proposed changes will clarify employers'
requirements for the communication of hazards of beryllium. Therefore,
OSHA is finalizing the proposed changes to paragraph (m) in this final
rule.
Recordkeeping.
Paragraph (n) of the beryllium standard for general industry
requires employers to make and maintain air monitoring data, objective
data, and medical surveillance records, and prepare and maintain
training records. The 2017 final rule required employers' air
monitoring data ((n)(1)(ii)(F)), medical surveillance ((n)(3)(ii)(A)),
and training ((n)(4)(i)) records to include employee Social Security
Numbers (SSNs). In the 2018 NPRM, OSHA proposed to modify paragraph (n)
to remove that requirement. This final rule adopts the proposed
revisions, eliminating the requirement to include employee SSNs in
these records.
The issue of whether to include employee SSNs in records under
OSHA's standards for beryllium dates back to the 2015 beryllium NPRM.
In that NPRM, OSHA proposed to require inclusion of employee SSNs in
records related to air monitoring, medical surveillance, and training,
similar to provisions in previous substance-specific health standards.
Some stakeholders objected to the proposed requirement based on
employee privacy and identity theft concerns (82 FR at 2730). OSHA
recognized the validity of these concerns, but preliminarily concluded
that due to the agency's past consistent practice of requiring an
employee's SSN on records, any change to this requirement should be
comprehensive and apply to all OSHA standards, not just the standards
for beryllium (82 FR at 2730).
In 2016, in its Standards Improvement Project-Phase IV (SIP-IV)
proposed rule (81 FR 68504, 68526-28 (October 4, 2016)), OSHA proposed
to delete the requirement that employers include employee SSNs in
records required by the agency's substance-specific standards. The 2017
final rule for beryllium included the SSN requirements, but, in the
preamble, OSHA recognized that the SIP-IV rulemaking was ongoing and
stated that it would revisit its decision to require employers to
include SSNs in beryllium records in light of the SIP-IV rulemaking, if
appropriate (82 FR at 2730).
The SIP-IV rulemaking was still ongoing when OSHA published the
2018 NPRM. Consistent with the SIP-IV proposal, OSHA proposed to modify
the beryllium standard for general industry by removing the requirement
to include SSNs in the recordkeeping provisions in paragraphs
(n)(1)(ii)(F) (air monitoring data), (n)(3)(ii)(A) (medical
surveillance), and (n)(4)(i) (training). OSHA noted that these proposed
revisions would address the privacy concerns raised in response to the
2015 NPRM, while maintaining safety and health protection for workers.
Three commenters, Phylmar Regulatory Roundtable, DOD, and Materion,
expressed general support for the proposed changes to the recordkeeping
provisions (Document ID 0020, p. 1; 0029, p. 1; 0038, p. 34), and no
commenters expressed opposition to OSHA's proposal to remove the
requirement to include each employee's SSN in these three sets of
records. After reviewing these comments, OSHA is finalizing the
proposed deletion of the SSN requirements in this final rule. This
change is also consistent with the agency's decision in the SIP-IV
rulemaking, which was finalized in the months since the publication of
the 2018 NPRM (84 FR 21416 (May 14, 2019)). The SIP-IV final rule
deletes the requirement to include employee SSNs in records employers
must maintain under the substance-specific standards that existed at
the time of OSHA's 2016 SIP-IV proposal (see 84 FR at 21439-40).\23\
The deletion of the SSN requirements in the beryllium general industry
standard will, thus, bring this standard into line with the majority of
OSHA's other substance-specific standards.
---------------------------------------------------------------------------
\23\ The beryllium standard for general industry, which was not
published until 2017, was not listed in the SIP-IV NPRM and,
therefore, the SIP-IV final rule did not affect the 2017 final
rule's requirement to include employee SSNs in records.
---------------------------------------------------------------------------
OSHA received one other comment related to SSNs in this rulemaking.
A private citizen agreed that the proposed changes were ``necessary and
appropriate,'' but expressed concerns that there is no additional
requirement to remove SSNs from existing records and that allowing
employers the option to continue using SSNs will not effectively
protect employee privacy (Document ID 0017). OSHA understands the
private citizen's concerns. The SIP-IV NPRM did not propose to require
employers to remove employee SSNs from existing records or to prohibit
employers from using employee SSNs in their records. The agency did,
however, request comment on whether employers should be required to use
an alternative identification system rather than SSNs, or to remove
SSNs from existing records (81 FR at 68528).
As discussed in the preamble to the SIP-IV final rule, the comments
that OSHA received in response to the SIP-IV NPRM advocated against
requiring employers to use an alternative type of employee identifier
or to remove SSNs from existing records (84 FR at 21440). For example,
the Construction Industry Safety Coalition (CISC) supported OSHA's
statements in the SIP-IV NPRM that employers would not be required to
delete employee SSNs from existing records, would not be required to
use an alternative employee identifier on existing records, and would
still be permitted to use SSNs if they wish to do so. CISC stated that
limiting employers' flexibility to come up with an identification
system that works best for their situations would create an undue
compliance burden (84 FR at 21440). After considering the comments,
OSHA decided in the SIP-IV final rule to proceed with removing the SSN
collection requirements from previously published standards, but not to
require employers to delete employee SSNs from existing records or to
use an alternative employee identifier.
In order to maintain consistency among OSHA recordkeeping
requirements for substance-specific standards, the agency has decided
not to require employers to delete employee SSNs from existing records
relating to beryllium or to use an alternative employee identifier. The
final rule allows employers the option to still use SSNs or to use some
other alternative employee identifier system, as explained in the SIP-
IV final rule. This will give employers the flexibility to choose the
best option for their particular circumstance and will avoid
unnecessarily increasing employers' compliance burdens.
Additional Comments.
The scope of the 2018 proposal was limited to the specific
revisions and clarifications to the beryllium standard identified in
the NPRM. The NPRM did not invite comment on all of the agency's
underlying determinations from the 2017 beryllium final rule. As such,
OSHA determined that some comments the agency received in response the
2018 NPRM pertained to subjects outside the scope of the proposal. OSHA
briefly addresses these comments below.
Two commenters addressed issues related to OSHA's significant risk
finding from the 2017 final rule. One commenter focused on the risk of
health effects related to beryllium exposure in the aluminum smelting
industry and the methodologies underlying OSHA's risk
assessment of occupational exposure to beryllium (Document ID 0026,
Attachment 2, pp. 9-16). Another took issue with OSHA's risk
determination pertaining to dermal contact with beryllium and argued
that the current standard did not distinguish between the chemical
forms of beryllium and its varying risk of injury from dermal contact
(Document ID 0038, pp. 13-15). OSHA addressed these concerns about risk
in the 2017 final rule and determined that the beryllium standard
addresses a significant risk (see 82 FR at 2545-52). The changes and
clarifications proposed by the 2018 NPRM do not affect that
determination.
Another commenter took issue with the revised PEL for beryllium set
in the 2017 final rule, suggesting that a lower PEL was needed to
protect workers from CBD and lung cancer (Document ID 0028, p. 1).
Although OSHA determined in the 2017 final rule that there remains a
significant risk of material impairment of health at the 0.2 [micro]g/
m\3\ PEL and the 2.0 ug/m\3\ STEL, the agency further determined that
it could not demonstrate that a lower PEL would be technologically
feasible (82 FR at 2552). Again, OSHA did not propose to revisit this
finding in this rulemaking.
List of Subjects for 29 CFR Part 1910
Beryllium, General industry, Health, Occupational safety and
health.
Authority
Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, directed the
preparation of this document. The agency issues the sections under the
following authorities: 29 U.S.C. 653, 655, 657; Secretary of Labor's
Order 1-2012 (77 FR 3912); 29 CFR part 1911; and 5 U.S.C. 553, as
applicable.
Signed at Washington, DC, on May 13, 2020.
Loren Sweatt,
Principal Deputy 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, part 1910 is amended to read as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
0
1. The authority section for part 1910, subpart Z, continues 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); and 29 CFR part 1911.
All of subpart Z issued under 29 U.S.C. 655(b), except those
substances that have exposure limits listed in Tables Z-1, Z-2, and
Z-3 of Sec. 1910.1000. The latter were issued under 29 U.S.C.
655(a).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5
U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic
(organic compounds), benzene, cotton dust, and chromium (VI)
listings.
Section 1910.1001 also issued under 40 U.S.C. 3704 and 5 U.S.C.
553.
Section 1910.1002 also issued under 5 U.S.C. 553, but not under
29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029, and 1910.1200 also issued under
29 U.S.C. 653.
Section 1910.1030 also issued under Public Law 106-430, 114
Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5
U.S.C. 553.
0
2. Amend Sec. 1910.1024 by:
0
A. Revising the definitions for ``Beryllium sensitization,''
``Beryllium work area,'' ``CBD diagnostic center,'' ``Chronic beryllium
disease (CBD),'' and ``Dermal contact with beryllium''.
0
B. Revise paragraphs (f)(1)(i)(D), (f)(ii)(B), (h)(2)(i), (h)(3)(iii),
(i)(1) introductory text, (i)(2), (i)(4)(ii), (j)(3), (k)(2)(i)(B),
(k)(2)(iii) and (iv), (k)(7)(i) introductory text, (k)(7)(ii) through
(vi), (l)(1)(i)(B), (l)(1)(ii), (m)(3), (m)(4)(ii)(A), (m)(4)(ii)(E),
(n)(1)(ii)(F), (n)(3)(ii)(A), (n)(4)(i), and Appendix A.
The revisions read as follows:
Sec. 1910.1024 Beryllium.
* * * * *
(b) * * *
Beryllium sensitization means a response in the immune system of a
specific individual who has been exposed to beryllium. There are no
associated physical or clinical symptoms and no illness or disability
with beryllium sensitization alone, but the response that occurs
through beryllium sensitization can enable the immune system to
recognize and react to beryllium. While not every beryllium-sensitized
person will develop chronic beryllium disease (CBD), beryllium
sensitization is essential for development of CBD.
Beryllium work area means any work area where materials that
contain at least 0.1 percent beryllium by weight are processed either:
(1) During any of the operations listed in Appendix A of this
standard; or
(2) Where employees are, or can reasonably be expected to be,
exposed to airborne beryllium at or above the action level.
CBD diagnostic center means a medical diagnostic center that has a
pulmonologist or pulmonary specialist on staff and on-site facilities
to perform a clinical evaluation for the presence of chronic beryllium
disease (CBD). The CBD diagnostic center must have the capacity to
perform 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 pulmonologist or pulmonary
specialist must be able to interpret the biopsy pathology and the BAL
diagnostic test results.
Chronic beryllium disease (CBD) means a chronic granulomatous lung
disease caused by inhalation of airborne beryllium by an individual who
is beryllium sensitized.
Confirmed positive means the person tested has had two abnormal
BeLPT test results, an abnormal and a borderline test result, or three
borderline test results, obtained from tests conducted within a three-
year period. It also means the result of a more reliable and accurate
test indicating a person has been identified as having beryllium
sensitization.
* * * * *
Dermal contact with beryllium means skin exposure to:
(1) Soluble beryllium compounds containing beryllium in
concentrations greater than or equal to 0.1 percent by weight;
(2) Solutions containing beryllium in concentrations greater than
or equal to 0.1 percent by weight; or
(3) Visible dust, fumes, or mists containing beryllium in
concentrations greater than or equal to 0.1 percent by weight. The
handling of beryllium materials in non-particulate solid form that are
free from visible dust containing beryllium in concentrations greater
than or equal to 0.1 percent by weight is not considered dermal contact
under the standard.
* * * * *
(f) * * *
(1) * * *
(i) * * *
(D) Procedures for minimizing cross-contamination, including the
transfer of beryllium between surfaces, equipment, clothing, materials,
and articles within beryllium work areas;
* * * * *
(ii) * * *
(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
exposure to beryllium; or
* * * * *
(h) * * *
(2) * * *
(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 all tasks involving
beryllium, or when personal protective clothing or equipment becomes
visibly contaminated with beryllium, whichever comes first.
* * * * *
(3) * * *
(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 exposure to beryllium and that the personal
protective clothing and equipment must be handled in accordance with
this standard.
* * * * *
(i) * * *
(1) General. For each employee working in a beryllium work area or
who can reasonably be expected to have dermal contact with beryllium,
the employer must:
* * * * *
(2) Change rooms. In addition to the requirements of paragraph
(i)(1)(i) of this standard, the employer must provide employees who are
required to use personal protective clothing or equipment under
paragraph (h)(1)(ii) of this standard 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.
* * * * *
(4) * * *
(ii) No employees enter any eating or drinking area with beryllium-
contaminated personal protective clothing or equipment unless, prior to
entry, it is cleaned, as necessary, to be as free as practicable of
beryllium by methods that do not disperse beryllium into the air or
onto an employee's body; and
* * * * *
(j) * * *
(3) Disposal, recycling, and reuse. (i) Except for intra-plant
transfers, when the employer transfers materials that contain at least
0.1 percent beryllium by weight or are contaminated with beryllium for
disposal, recycling, or reuse, the employer must label the materials in
accordance with paragraph (m)(3) of this standard;
(ii) Except for intra-plant transfers, materials designated for
disposal that contain at least 0.1 percent beryllium by weight or are
contaminated with beryllium must be cleaned to be as free as
practicable of beryllium or placed in enclosures that prevent the
release of beryllium-containing particulate or solutions under normal
conditions of use, storage, or transport, such as bags or containers;
and
(iii) Except for intra-plant transfers, materials designated for
recycling or reuse that contain at least 0.1 percent beryllium by
weight or are contaminated with beryllium must be cleaned to be as free
as practicable of beryllium or placed in enclosures that prevent the
release of beryllium-containing particulate or solutions under normal
conditions of use, storage, or transport, such as bags or containers.
* * * * *
(k) * * *
(2) * * *
(i) * * *
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) 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. Each employee who meets the criteria of
paragraph (k)(1)(i)(C) of this standard and who has not received an
examination since exposure to beryllium during the emergency must be
provided an examination at the time the employee's employment
terminates.
(iv) For an employee who meets the criteria of paragraph
(k)(1)(i)(C) of this standard:
(A) If that employee has not received a medical examination within
the previous two years pursuant to paragraph (k)(1)(i) of this
standard, then within 30 days after the employee meets the criteria of
paragraph (k)(1)(i)(C) of this standard; or
(B) If that employee has received a medical examination within the
previous two years pursuant to paragraph (k)(1)(i) of this standard,
then at least one year but no more than two years after the employee
meets the criteria of paragraph (k)(1)(i)(C) of this standard.
* * * * *
(7) * * *
(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 evaluation at the CBD diagnostic center
must be scheduled within 30 days, and must occur within a reasonable
time, of:
* * * * *
(ii) The employer must ensure that, as part of the evaluation, the
employee is offered any tests deemed appropriate by the examining
physician at the CBD diagnostic center, such as pulmonary function
testing (as outlined by the American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and transbronchial biopsy. If any of the
tests deemed appropriate by the examining physician are not available
at the CBD diagnostic center, they may be performed at another location
that is mutually agreed upon by the employer and the employee.
(iii) 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.
(iv) 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.
(v) 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.
(vi) After an employee has received the initial clinical evaluation
at a CBD diagnostic center described in paragraphs (k)(7)(i) and (ii)
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) * * *
(1) * * *
(i) * * *
(B) A written medical report recommending removal from airborne
exposure to beryllium in accordance with paragraph (k)(5)(v) or
(k)(7)(iii) 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)(iv) of this standard.
* * * * *
(m) * * *
(3) Warning labels. Consistent with the HCS (Sec. 1910.1200), the
employer must label each immediate 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) * * *
(ii) * * *
(A) The health hazards associated with airborne exposure to and
dermal contact with beryllium, including the signs and symptoms of CBD;
* * * * *
(E) Measures employees can take to protect themselves from airborne
exposure to and dermal contact with beryllium, including personal
hygiene practices;
* * * * *
(n) * * *
(1) * * *
(ii) * * *
(F) The name and job classification of each employee represented by
the monitoring, indicating which employees were actually monitored.
* * * * *
(3) * * *
(ii) * * *
(A) Name and job classification;
* * * * *
(4) * * *
(i) At the completion of any training required by this standard,
the employer must prepare a record that indicates the name and job
classification of each employee trained, the date the training was
completed, and the topic of the training.
* * * * *
(p) Appendix. Table A.1 in this appendix sets forth the operations
that, where performed under the circumstances described in the column
heading above the particular operations, trigger the requirement for a
beryllium work area.
Appendix A to Sec. 1910.1024--Operations for Establishing Beryllium
Work Areas
Paragraph (b) of this standard defines a beryllium work area as
any work area where materials that contain at least 0.1 percent
beryllium by weight are processed (1) during any of the operations
listed in Appendix A of this standard, or (2) where employees are,
or can reasonably be expected to be, exposed to airborne beryllium
at or above the action level. Table A.1 in this appendix sets forth
the operations that, where performed under the circumstances
described in the column heading above the particular operations,
trigger the requirement for a beryllium work area.
Table A.1--Operations for Establishing Beryllium Work Areas Where
Processing Materials Containing at Least 0.1 Percent Beryllium by Weight
------------------------------------------------------------------------
Beryllium composite
Beryllium metal alloy operations (generally
operations (generally >10% beryllium by Beryllium oxide
<10% beryllium by weight) and beryllium operations
weight) metal operations
------------------------------------------------------------------------
Abrasive Blasting. Abrasive Blasting. Abrasive Blasting.
Abrasive Processing. Abrasive Processing. Abrasive Processing.
Abrasive Sawing. Abrasive Sawing. Abrasive Sawing.
Annealing. Annealing. Boring.
Bright Cleaning. Atomizing. Brazing (>1,100 [deg]C).
Brushing. Attritioning. Broaching with green
ceramic.
Buffing. Blanking. Brushing.
Burnishing. Bonding. Buffing.
Casting. Boring. Centerless grinding.
Centerless Grinding. Breaking. Chemical Cleaning.
Chemical Cleaning. Bright Cleaning. Chemical Etching.
Chemical Etching. Broaching. CNC Machining.
Chemical Milling. Brushing. Cold Isostatic Pressing
(CIP).
Dross Handling. Buffing. Crushing.
Deburring (grinding). Burnishing. Cutting.
Electrical Chemical Casting. Deburring (grinding).
Machining (ECM).
Electrical Discharge Centerless Grinding. Deburring (non-
Machining (EDM). grinding).
Extrusion. Chemical Cleaning. Destructive Testing.
Forging. Chemical Etching Dicing.
Grinding. Chemical Milling. Drilling.
Heat Treating (in CNC Machining Dry/wet Tumbling.
air).
High Speed Machining Cold Isostatic Extrusion.
(>10,000 rpm). Pressing.
Hot Rolling. Cold Pilger. Filing by Hand.
Lapping. Crushing. Firing of Green Ceramic.
Laser Cutting. Cutting. Firing of Refractory
Metallization (>1,100
[deg]C).
Laser Machining. Deburring. Grinding.
Laser Scribing. Dicing. Honing.
Laser Marking. Drawing. Hot Isostatic Pressing
(HIP).
Melting. Drilling. Lapping.
Photo-Etching. Dross Handling. Laser Cutting.
Pickling. Electrical Chemical Laser Machining.
Machining (ECM).
Point and Chamfer. Electrical Discharge Laser Scribing.
Machining (EDM).
Polishing. Extrusion. Laser Marking.
Torch Cutting (i.e., Filing by Hand. Machining.
oxy-acetylene).
Tumbling. Forging. Milling.
Water-jet Cutting. Grinding. Piercing.
Welding. Heading. Mixing.
Sanding. Heat Treating. Plasma Spray.
Slab Milling. Honing. Polishing.
Hot Isostatic Pressing Powder Handling.
(HIP).
Lapping. Powder Pressing.
Laser Cutting. Reaming.
Laser Machining. Sanding.
Laser Scribing. Sectioning.
Laser Marking. Shearing.
Machining. Sintering of Green
Ceramic.
Melting. Sintering of Refractory
Metallization (>1,100
[deg]C).
Milling. Snapping.
Mixing. Spray Drying.
Photo-Etching. Tape Casting.
Pickling. Turning.
Piercing. Water Jet Cutting.
Pilger.
Plasma Spray.
Point and Chamfer.
Polishing.
Powder Handling.
Powder Pressing.
Pressing.
Reaming.
Roll Bonding.
Rolling.
Sanding.
Sawing (tooth blade).
Shearing.
Sizing.
Skiving.
Slitting.
Snapping.
Sputtering.
Stamping.
Spray Drying.
Tapping.
Tensile Testing.
Torch Cutting (i.e.,
oxy acetylene).
Trepanning.
Tumbling
Turning.
Vapor Deposition.
Water-Jet Cutting.
Welding.
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[FR Doc. 2020-10678 Filed 7-13-20; 8:45 am]
BILLING CODE P
