[Federal Register: December 26, 2007 (Volume 72, Number 246)][Proposed Rules] [Page 72971-72976]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de07-27]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2007-0006]
RIN 1218-AC29
Abbreviated Bitrex® Qualitative Fit-Testing Protocol
AGENCY: Occupational Safety and Health Administration (OSHA); Labor.
ACTION: Notice of proposed rulemaking and request for comments.
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SUMMARY: OSHA is proposing to include the protocol for the abbreviated
Bitrex® qualitative fit test ("ABQLFT") in its Respiratory
Protection Standard; the proposed protocol would apply to employers in
general industry, shipyard employment, and the construction industry.
The proposed ABQLFT protocol consists of seven exercises described in
the existing Bitrex® qualitative fit-testing protocol specified
in OSHA's Respiratory Protection Standard. However, each of the
exercises in the proposed ABQLFT protocol lasts 15 seconds, compared to
60 seconds for exercises in the existing Bitrex® qualitative
fit-testing protocol. This proposal describes the test sensitivity,
predictive value of a pass, test specificity, and predictive value of a
fail for the ABQLFT protocol, and requests the public to comment on
whether this evidence supports OSHA including the ABQLFT in the
Respiratory Protection Standard.
DATES: Comments to this proposal, including comments to the
information-collection (paperwork) determination described under the
SUPPLEMENTARY INFORMATION section, must be submitted (postmarked, sent,
or received) by February 25, 2008.
ADDRESSES: Comments may be submitted as follows:
Electronic: Comments may be submitted electronically to
http://www.regulations.gov, which is the Federal eRulemaking portal.
Follow the instructions online for submitting comments.
Facsimile: OSHA allows facsimile transmission of comments
that are 10 pages or fewer in length (including attachments). Send
these comments to the OSHA Docket Office at (202) 693-1648; hard copies
of these comments are not required. Instead of transmitting facsimile
copies of attachments that supplement their comments (e.g., studies,
journal articles), commenters may submit these attachments, in
triplicate hard copy, to the OSHA Docket Office, Technical Data Center,
Room N-2625, OSHA, U.S. Department of Labor, 200 Constitution Ave.,
NW., Washington, DC 20210. These attachments must clearly identify the
sender's name, date, subject, and docket number (i.e., OSHA-2007-0006)
so that the Agency can attach them to the appropriate comments.
Regular mail, express delivery, hand (courier) delivery,
and messenger service: Submit three copies of comments and any
additional material (e.g., studies, journal articles) to the OSHA
Docket Office, Docket No. OSHA-2007-0006 or RIN No. 1218-AC29,
Technical Data Center, Room N-2625, OSHA, Department of Labor, 200
Constitution Ave., NW., Washington, DC 20210; telephone: (202) 693-
2350. (OSHA's TTY number is (877) 889-5627.) Please contact the OSHA
Docket Office for information about security procedures concerning
delivery of materials by express delivery, hand delivery, and messenger
service. The hours of operation for the OSHA Docket Office are 8:15
a.m. to 4:45 p.m., e.t.
Instructions: All submissions must include the Agency name
and the OSHA docket number (i.e., OSHA-2007-0006). Comments and other
material, including any personal information, are placed in the public
docket without revision, and will be available online at http://www.regulations.gov.
Therefore, the Agency cautions commenters about submitting statements
they do not want made available to the public, or submitting comments
that contain personal information (either about themselves or others)
such as social security numbers, birth dates, and medical data.
Docket: To read or download comments or other material in
the docket, go to http://www.regulations.gov or to the OSHA Docket
Office at the address above. Documents in the docket are listed in the
http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through this Web site. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.
Contact the OSHA Docket Office for assistance in locating docket
submissions.
FOR FURTHER INFORMATION CONTACT: For general information and press
inquiries, contact Mr. Kevin Ropp, Director, Office of Communications,
OSHA, U.S. Department of Labor, Room N-3637, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone: (202) 693-1999; facsimile: (202)
693-1634. For technical inquiries, contact Mr. John E. Steelnack,
Directorate of Standards and Guidance, Room N-3718, OSHA, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone: (202) 693-2289; facsimile: (202) 693-1678.
Copies of this Federal Register notice are available from the OSHA
Office of Publications, Room N-3101, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington DC 20210; telephone: (202) 693-
1888. Electronic copies of this Federal Register notice, as well as
news releases and other relevant documents, are available at OSHA's Web
page at http://www.osha.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Summary and Explanation of the Proposal
A. Introduction
B. Summary of the Peer-Reviewed Article
C. Conclusions
D. Issues for Public Comment
III. Procedural Determinations
A. Legal Considerations
B. Preliminary Economic Analysis and Regulatory Flexibility
Certification
C. Paperwork Reduction Act
D. Federalism
E. State-Plan States
F. Unfunded Mandates Reform Act
G. Applicability of Existing Consensus Standards
H. Review of the Proposed Standard by the Advisory Committee for
Construction Safety and Health (ACCSH)
List of Subjects
Authority and Signature
IV. Proposed Amendment to the Standard
I. Background
Appendix A of OSHA's Respiratory Protection Standard at 29 CFR
1910.134 currently includes four qualitative fit-testing protocols
using the following challenge agents: isoamyl acetate; saccharin-
solution aerosol; Bitrex® (denatonium benzoate) aerosol in
solution; and irritant smoke (stannic chloride). Appendix A of the
Respiratory Protection Standard also specifies the procedure for adding
new test protocols to this standard. The criteria for determining
whether OSHA must publish a fit-testing protocol for notice-and-comment
rulemaking under Section 6(b)(7) of the Occupational Safety and Health
Act of 1970 (29 U.S.C. 655) include: (1) A test report prepared by an
independent government research laboratory (e.g., Lawrence Livermore
National Laboratory, Los Alamos National Laboratory, the National
Institute for Standards and Technology) stating that the laboratory
tested the protocol and found it to be accurate and reliable; or (2) an
article published in a peer-reviewed industrial-hygiene journal describing
the protocol and explaining how the test data support the protocol's accuracy
and reliability.
II. Summary and Explanation of the Proposal
A. Introduction
In the letter submitting the abbreviated Bitrex® qualitative
fit-testing ("ABQLFT") protocol for review under the provisions of
Appendix A of OSHA's Respiratory Protection Standard (Ex. OSHA-2007-
0006-0002), Dr. Michael L. Runge of the 3M Company included a copy of a
peer-reviewed article from an industrial-hygiene journal describing the
accuracy and reliability of the proposed ABQLFT protocol (Ex. OSHA-
2007-0006-0003). This article also described in detail the equipment
and procedures required to administer the proposed ABQLFT protocol.
According to this description, the proposed protocol is a variation of
the existing Bitrex® qualitative fit-testing protocol developed
by the 3M Company in the early 1990s, which OSHA approved for inclusion
in the final Respiratory Protection Standard. The proposed ABQLFT
protocol uses the same fit-testing requirements and instrumentation
specified for the existing Bitrex® qualitative fit-testing
protocol in paragraphs (a) and (b) of Part I.B.4 of Appendix A of the
Respiratory Protection Standard, with the following two exceptions:
Exercise times are reduced from 60 seconds to 15 seconds;
and
The proposed ABQLFT protocol is used only with test
subjects who can taste the Bitrex® screening solution within the
first 10 squeezes of the nebulizer bulb (referred to as "Level 1
sensitivity").
B. Summary of the Peer-Reviewed Article
The peer-reviewed article, entitled "Development of an Abbreviated
Qualitative Fit Test Using Bitter Aerosol," appeared in the Fall/
Winter 2003 issue of the Journal of the International Society for
Respiratory Protection (Ex. OSHA-2007-0006-0003). The authors of this
study were T.J. Nelson of NIHS, Inc., and L.L. Janssen, M.D.
Luinenburg, and H.E. Mullins of the 3M Company; the 3M Company
supported the study. This article describes a study that determined
whether performing a fit test involving seven exercises lasting 15
seconds each while exposed to Bitrex® (referred to as the
abbreviated Bitrex® qualitative fit test or "ABQLFT") yielded
fit-testing results similar to results obtained with a generated-
aerosol (i.e., corn oil) quantitative fit test ("GAQNFT") using one-
minute exercises (i.e., the GAQNFT was the criterion measure or "gold
standard").
The study involved 43 experienced respirator users, 20 females and
23 males. The test subjects followed the existing Bitrex®
qualitative fit-testing protocol in Appendix A of OSHA's Respiratory
Protection Standard except that they performed each of the fit-testing
exercises for 15 seconds (instead of 60 seconds) while wearing a NIOSH-
certified elastomeric half-mask respirator equipped with P100 filters.
The authors selected the best fitting respirator for each test subject
from among four models, each available in three sizes; some test
subjects used more than one model during fit testing. In addition, the
authors induced poor respirator fits by assigning a respirator to test
subjects that was one or two sizes too small or too large as determined
by the Los Alamos National Laboratory panel-grid size and observation
of the test subjects' facial characteristics. Test subjects could
adjust the respirator facepiece for comfort, but they did not perform
user seal checks.
In conducting the study, the authors used the recommendations for
evaluating new fit-test methods specified by Annex A2 of ANSI Z88.10-
2001, including sequencing the ABQLFT and GAQNFT in random order
without disturbing facepiece fit. The authors used fit-test sample
adaptors or respirators with fixed probes to collect samples inside the
respirator. The sample point inside the respirator was located between
the nose and the mouth. For both fit tests, the authors had the test
subjects perform seven of the eight exercises listed in Part I.A.14 of
Appendix A of OSHA's Respiratory Protection Standard, which included:
normal breathing, deep breathing, turning the head side to side, moving
the head up and down, reading a passage, bending over, and normal
breathing.\1\ For the GAQNFT, the authors performed particle counts at
one-second intervals inside a test chamber for 15-30 seconds before and
after fit testing, and inside the respirator for the 60-second duration
of each exercise.
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\1\ The test subjects did not perform the grimace exercise.
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The 43 test subjects used in the study had Level 1 sensitivity to
Bitrex® because they were able to taste the Bitrex®
aerosol within 10 squeezes of the nebulizer bulb. Subjects having Level
2 or 3 sensitivity to Bitrex® were excluded from further
participation in thestudy because the nebulizer could not be
replenished for additional taste testing within the 15 seconds allotted
to perform each fit-testing exercise. After the test subjects passed a
Bitrex® sensitivity-screening test, the authors administered the
ABQLFT using the procedures and techniques specified for the existing
Bitrex® qualitative fit-testing protocol in Part I.B.14 of
Appendix A of OSHA's Respiratory Protection Standard, and determined
the fit factor using the particle count for the 15-second duration of
each exercise.
The authors required a fit factor of 100 to pass a fit test, which
served as the basis for determining the following statistics for the
ABQLFT: test sensitivity; predictive value of a pass; test specificity;
and predictive value of a fail. In calculating these statistics, the
authors adopted the variables defined by ANSI Z88.10-2001, in which: A
= false positives (passed the fit test with a fit factor < 100); B =
true positives (passed the fit test with a fit factor > 100); C = true
negatives (failed the fit test with a fit factor >= 100); and D = false
negatives (failed the fit test with a fit factor >= 100). Using these
variables, ANSI Z88.10-2001 specifies the formula and recommended value
("RV") for each statistic as follows: Test sensitivity = C / (A + C),
RV > 0.95; predictive value of a pass = B / (A + B), RV > 0.95; test
specificity = B / (B + D), RV > 0.50; and predictive value of a fail =
C / (C + D), RV > 0.50.
Using the GAQNFT as the criterion measure, the variables for the
ABQLFT had the following values: A = 4; B = 95; C = 48; and D = 20. The
statistics calculated for the ABQLFT from these values were: test
sensitivity = 0.92; predictive value of a pass = 0.96; test specificity
= 0.83; and predictive value of a fail = 0.71. Therefore, every
statistic for the ABQLFT, except test sensitivity, attained a value in
excess of the ANSI Z88.10-2001 recommended value.
The test-sensitivity value of 0.92 for the ABQLFT fell below the
ANSI recommended value of 0.95. The authors state that this slight
difference represents a single false positive value for the ABQLFT
(i.e., failed the GAQNFT but passed the ABQLFT). However, an additional
peer-reviewed article submitted by Dr. Runge of the 3M Company suggests
an alternative approach to examining these test-sensitivity values (see
Ex. OSHA-2007-0006-0004). This article, entitled "Recommendations for
the Acceptance Criteria for New Fit Test Methods" and published in the
Spring/Summer 2004 issue of the Journal of the International Society
for Respiratory Protection, describes an analytical study conducted
by T.J. Nelson of NIHS, Inc. and H. Mullins of the 3M Company, and
supported by the 3M Company. In this study, the authors performed a
binary logistic-regression analysis on pass-fail fit-testing data from
published studies involving two quantitative, and two qualitative, fit
tests. The authors justify using the binary logistic-regression
analysis for this purpose as follows:
When a simple sensitivity test is used to describe a new test,
the result can be affected by the distribution of the data. In
several cases using the theoretical distributions described in this
paper, the outcome of a sensitivity test for the Bitrex and Ambient
Particle Counter fit tests could have failed to meet the ANSI Z88.10
sensitivity requirement. The method used to determine acceptability
should be independent of specific data collected. (See Ex. OSHA-
2007-0006-0004, p. 8.)
The results of the binary logistic-regression analysis performed on the
ABQLFT data showed that the ABQLFT had a 0.20 probability of passing a
respirator user with a fit factor of 50 and a 0.33 probability of
passing a respirator user with a fit factor of 100. Figure 3 of the
article compares the binary logistic-regression analysis results of
test-sensitivity values obtained for a popular quantitative fit test
and the existing 60-second Bitrex® qualitative fit test. The
authors conclude that the analysis demonstrates that the distribution
of fit-testing data affected the test-sensitivity values derived using
the ANSI Z88.10-2001 test-sensitivity calculations. Based on this
analysis, the authors assert that "a sensitivity calculation may not
be the best indicator of fit test method performance. The binary
logistic regression analysis shows that the result of the 15 second
exercise time test is very similar to the ambient aerosol and 60 second
bitter aerosol tests" (Ex. OSHA-2007-0006-0003, p. 108). In
summarizing the study's results, the authors state that "[t]he 15
second bitter aerosol protocol sufficiently screens for adequate
respirator fit in subjects with Level 1 Bitrex taste sensitivity."
C. Conclusions
OSHA believes that the information submitted by Dr. Runge in
support of the proposed ABQLFT protocol meets the criteria for proposed
fit-testing protocols established by the Agency in Part II of Appendix
A of its Respiratory Protection Standard. Therefore, the Agency
concludes that the proposed ABQLFT protocol warrants notice-and-comment
rulemaking under Section 6(b)(7) of the OSH Act, and is initiating this
rulemaking to determine whether to approve the proposed protocol for
inclusion in Part I of Appendix A of its Respiratory Protection
Standard.
An important difference between the proposed ABQLFT protocol and
the existing Bitrex® qualitative fit-testing protocol specified
currently in Part I.B.4 of Appendix A of the Respiratory Protection
Standard is the duration of the exercises used during fit testing. The
Agency is taking comments on whether to add the ABQLFT protocol to Part
I.B.4 of Appendix A (see section IV, "Proposed Amendment to the
Standard," below); in addition to decreasing exercise durations from
60 seconds to 15 seconds each, the new regulatory text would limit use
of the proposed ABQLFT to respirator users who demonstrate Level 1
sensitivity to Bitrex®. If approved, the proposed ABQLFT
protocol would be an alternative to the existing qualitative fit-
testing protocols already listed in the Part I of Appendix A of the
Respiratory Protection Standard; employers would be free to select this
alternative or to continue using any of the other protocols currently
listed in the Appendix.
D. Issues for Public Comment
OSHA invites comments and data from the public regarding the
accuracy and reliability of the proposed ABQLFT protocol, its
effectiveness in detecting respirator leakage, and its usefulness in
selecting respirators that will protect employees from airborne
contaminants in the workplace. Specifically, the Agency invites public
comment on the following issues:
Were the studies described in the submitted articles well
controlled, and conducted according to accepted experimental design
practices and principles?
Were the results of the studies described in the submitted
articles properly, fully, and fairly presented and interpreted?
Will the proposed ABQLFT protocol generate reproducible
fit-testing results, and what additional experiments or analyses of
existing data are necessary to answer this question?
Will the proposed ABQLFT protocol reliably identify
respirators with unacceptable fit as effectively as the qualitative
fit-testing protocols, including the existing Bitrex®
qualitative fit-testing protocol, already listed in Part I.B of
Appendix A of the Respiratory Protection Standard?
What is the significance of the test-sensitivity value of
0.92 obtained for the ABQLFT relative to the test-sensitivity value of
0.95 recommended by ANSI Z88.10-2001, and does the authors' assertion
that "a sensitivity calculation may not be the best indicator of fit
test method performance" adequately account for the lower test-
sensitivity value?
What is the significance of limiting the ABQLT to
respirator users who demonstrate Level 1 sensitivity to Bitrex®?
III. Procedural Determinations
A. Legal Considerations
The purpose of the Occupational Safety and Health Act of 1970
("OSH 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 to
promulgate and enforce occupational safety and health standards. (29
U.S.C. 655(b) and 654(b).) A safety or health standard is a standard
that "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 or
places of employment." (29 U.S.C. 652(8).) A standard is reasonably
necessary or appropriate within the meaning of Section 652(8) of the
OSH Act when a significant risk of material harm exists in the
workplace, and the standard will substantially reduce or eliminate that
workplace risk.
Employers covered by this proposal already must comply with the
fit-testing requirements specified in paragraph (f) of OSHA's
Respiratory Protection Standard at 29 CFR 1910.134. Accordingly, these
provisions currently are protecting their employees from the
significant risk that results from poorly fitting respirators. For this
proposal, the Agency preliminarily determined that the proposed ABQLFT
fit-testing protocol provides employees with protection that is
comparable to the protection afforded to them by the existing
Bitrex® qualitative fit-testing provisions. In this regard, the
proposal is not expected to replace existing fit-testing protocols, but
instead would be an alternative to them. Therefore, OSHA preliminarily
finds that the proposal would not directly increase or decrease the
protection afforded to employees, nor would it increase employers'
compliance burdens. As demonstrated in the following section, the
proposal may reduce employers' compliance burdens by decreasing the
time required to fit test respirators for employee use. Accordingly,
OSHA concludes that it is unnecessary to determine significant risk or
the extent to which this proposal would reduce that risk, as typically
would be required by Industrial Union Department, AFL-CIO v. American
Petroleum Institute, 448 U.S. 607 (1980).
B. Preliminary Economic Analysis and Regulatory Flexibility
Certification
The proposal is not economically significant within the context of
Executive Order ("E.O.") 12866 (58 FR 51735). Additionally, the
proposal is not a "major rule" under Section 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 ("SBREFA"; 5
U.S.C. 804). The proposal would impose no additional costs on any
private- or public-sector entity, and does not meet any of the criteria
for an economically significant or major rule specified by E.O. 12866
or other relevant statutes.
The proposal offers employers an additional option to fit test
their employees for respirator use. In addition to the existing
Bitrex® qualitative fit-testing protocol, which would continue
to be an option, the Agency would add the ABQLFT protocol as a
supplemental option if OSHA approves it as a result of this proposed
rulemaking. According to a recent National Institute for Occupational
Safety and Health-Bureau of Labor Statistics survey of respirator use,
approximately 25,000 establishments currently use the existing
Bitrex® qualitative fit-testing protocol out of nearly 282,000
establishments requiring respirator use (Ex. 6-3, Docket H-049C).
Under this proposal, employers would have a choice between any of
the existing fit-testing protocols, including the existing
Bitrex® qualitative fit-testing protocol consisting of exercises
lasting one minute each, or the new ABQLFT protocol. By providing
regulatory flexibility to these employers, the proposal may reduce
their costs by decreasing fit-testing time. In this regard, OSHA
assumes that the proposed ABQLFT protocol would be adopted by some
employers who use the existing Bitrex® qualitative fit-testing
protocol for those employees with Level 1 sensitivity. These employers
would adopt the proposed ABQLFT protocol because it consists of
exercises lasting a shorter duration than the exercises in the existing
Bitrex® qualitative fit-testing protocol, thereby decreasing the
time and cost required for fit testing their employees. However, the
Agency believes that the proposed protocol is unlikely to be adopted by
employers who currently use the generated-aerosol, ambient-aerosol
condensation-nuclei counter, or contingent-negative pressure
quantitative fit-testing systems because of the significant equipment
and training investment they already have made to administer these fit
tests.
Based on the above discussion, the Agency preliminarily concludes
that this proposed rulemaking would impose no additional costs on
employers, thereby eliminating the need for a preliminary economic
analysis. Moreover, OSHA certifies that the proposal would not have a
significant impact on a substantial number of small entities, and that
the Agency does not have to prepare an initial regulatory flexibility
analysis for this rulemaking under the SBREFA (5 U.S.C. 601 et seq.).
C. Paperwork Reduction Act
After thoroughly analyzing the proposed fit-testing provisions in
terms of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.
and 5 CFR part 1320), OSHA believes that these provisions would not add
to the existing collection-of-information (i.e., paperwork)
requirements regarding fit testing employees for respirator use. The
paperwork requirement specified in paragraph (m)(2) of OSHA's
Respiratory Protection Standard at 29 CFR 1910.134 specifies that
employers must document and maintain the following information on
qualitative fit tests administered to employees: The name or
identification of the employee tested; the type of fit test performed;
the specific make, model, style, and size of respirator tested; the
date of the test; and the test results. The employer must maintain this
record until the next fit test is administered. However, this paperwork
requirement would remain the same whether employers currently use the
other fit-testing protocols already listed in Part I of Appendix A of
the Respiratory Protection Standard, or implement the proposed fit-
testing protocol instead. Therefore, using the proposed fit-testing
protocol in the context of the existing fit-testing protocols would not
involve an additional paperwork-burden determination by OSHA because it
already accounts for this burden under the paperwork analysis for the
Respiratory Protection Standard (OMB Control Number 1218-0099).
Members of the public may send comments on this paperwork analysis
to: Office of Information and Regulatory Affairs (Attention: Desk
Officer for OSHA), Office of Management and Budget, Room 10235, 725
17th Street, NW., Washington, DC 20503. The Agency also encourages
commenters to submit a copy of their comments on this paperwork
analysis to OSHA, along with their other comments on the proposed rule.
D. Federalism
The Agency reviewed the proposal according to the most recent
Executive Order ("E.O.") on Federalism (E.O. 13132; 64 FR 43225),
which requires that Federal agencies, to the extent possible, refrain
from limiting State policy options, consult with States before taking
actions that restrict their policy options, and take such actions only
when clear constitutional authority exists and the problem is national
in scope. E.O. 13132 allows Federal agencies to preempt State law only
with the expressed consent of Congress. In such cases, Federal agencies
must limit preemption of State law to the extent possible.
Under Section 18 of the Occupational Safety and Health Act of 1970
("OSH Act"; 29 U.S.C. 651 et seq.), Congress expressly authorizes
OSHA to preempt State occupational safety and health standards. Under
the OSH Act, a State can avoid such preemption only when it has an
OSHA-approved occupational safety and health plan (i.e., is a "State-
plan State"; see 29 U.S.C. 667). Occupational safety and health
standards developed by a State-Plan State must be at least as effective
in providing safe and healthful employment and places of employment as
the Federal standards. Subject to the limitations specified by the OSH
Act at 29 U.S.C. 667, State-Plan States are free to develop and enforce
their own requirements for safety and health standards under State law.
This proposed rulemaking complies with E.O. 13132. In States
without OSHA-approved State Plans, Congress expressly provides for
Agency standards to preempt State job safety and health rules in areas
addressed by the Federal standards; in these States, the proposed rule
would limit State policy options in the same manner as every OSHA
standard. Therefore, with respect to States that do not have OSHA-
approved plans, the Agency concludes that this proposal conforms to the
preemption provisions of the OSH Act. Additionally, Section 18 of the
OSH Act prohibits States without approved plans from issuing citations
for violations of OSHA standards; the Agency finds that the proposed
rulemaking does not expand this limitation.
OSHA has authority under E.O. 13132 to propose the use of the
ABQLFT protocol under its Respiratory Protection Standard at 29 CFR
1910.134 because the problems addressed by these fit-testing
requirements are national in scope. In this regard, the proposal offers
hundreds of thousands of employers across the nation an opportunity to
use an additional protocol to assess respirator fit among their employees.
Therefore, the proposal would provide employers in every State with an
alternative means of complying with the fit-testing requirements specified
in paragraph (f) of OSHA's Respiratory Protection Standard.
Should the Agency adopt a proposed standard in a final rulemaking,
Section 18(c)(2) of the OSH Act (29 U.S.C. 667(c)(2)) requires State-
plan States to adopt the same standard, or develop an alternative that
is at least as effective as the OSHA standard. However, the new fit-
testing protocol proposed in this rulemaking would only provide
employers with an alternative to the existing requirements for fit-
testing protocols specified in the Respiratory Protection Standard;
therefore, the alternative is not, itself, a mandatory standard.
Accordingly, States with OSHA-approved State Plans would not be
obligated to adopt the final provisions that may result from this
rulemaking. Nevertheless, OSHA strongly encourages them to adopt the
final provisions to provide compliance options to employers in their
States.
E. State-Plan States
When Federal OSHA promulgates a new standard or imposes additional
or more stringent requirements than an existing standard, the 26 States
and U.S. Territories with their own OSHA-approved occupational safety
and health plans (i.e., "State-Plan States") must revise their
standards to reflect the new OSHA standard or amendment, or show the
Agency why such action is unnecessary (e.g., because an existing State
standard covering this area already is at least as effective in
protecting employees as the new Federal standard or amendment (29 CFR
1953.5(a))). The State standard must be (1) at least as effective as
the final Federal rule in protecting employees, (2) applicable to both
the private and public (i.e., State and local government employees)
sectors, and (3) completed within six months of the publication date of
the final Federal rule.
When OSHA promulgates a new standard or amendment that does not
impose additional or more stringent requirements than an existing
standard, State-Plan States are not required to revise their standards,
although the Agency may encourage them to do so. Accordingly, the
Agency strongly encourages the 26 States and U.S. Territories with
their own OSHA-approved occupational safety and health plans to revise
their current Respiratory Protection Standard should the Agency adopt
the proposed fit-testing protocol based on this rulemaking. OSHA
preliminarily concludes that such a revision would provide employers in
the State-plan States with any economic benefits that may accrue from
such enactment, while protecting the safety and health of employees who
use respirators against hazardous airborne substances in the workplace
at least as well as the existing Bitrex® qualitative fit-test
protocol. These States and U.S. Territories are: 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. Connecticut, New Jersey, New York, and the Virgin Islands have
OSHA-approved State Plans that apply to State and local government
employees only.
F. Unfunded Mandates Reform Act
OSHA reviewed the proposal according to the Unfunded Mandates
Reform Act of 1995 ("UMRA"; 2 U.S.C. 1501 et seq.) and Executive
Order 12875. As discussed above in section III.B ("Preliminary
Economic Analysis and Regulatory Flexibility Certification") of this
preamble, the Agency made a preliminary determination that the proposal
imposes no additional costs on any private- or public-sector entity.
The substantive content of the proposal applies only to employers whose
employees use respirators for protection against airborne workplace
contaminants, and compliance with the proposal would be strictly
optional for these employers. Accordingly, the proposal would require
no additional expenditures by either public or private employers.
As noted above under section III.E ("State-Plan States") of this
preamble, OSHA standards do not apply to State and local governments
except in States that have voluntarily elected to adopt a State Plan
approved by the Agency. Consequently, this proposal 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 the proposal does not mandate that
State, local, or tribal governments adopt new, unfunded regulatory
obligations, or increase expenditures by the private sector of more
than $100 million in any year.
G. Applicability of Existing Consensus Standards
When OSHA promulgated its original respirator fit-testing protocols
under Appendix A of its final Respiratory Protection Standard (29 CFR
1910.134), no national consensus standards addressed these protocols.
However, the American National Standards Institute (ANSI) subsequently
developed a national consensus standard on fit-testing protocols
("Respirator Fit Testing Methods," ANSI Z88.10-2001) as an adjunct to
its national consensus standard on respiratory-protection programs.
Paragraph 7.3 of ANSI Z88.10-2001 provides the requirements for
conducting the Bitrex® qualitative fit test, including
requirements for administering the fit test; these requirements are
consistent with the existing Bitrex® qualitative fit-testing
requirements specified in Part I.B.4 of OSHA's Respiratory Protection
Standard, except that the ANSI exercises must last at least 30 seconds
each while the exercises required by the OSHA standard must last 60
seconds each. In addition, section 9 and Table 1 of ANSI Z88.10-2001
describe the exercises required during fit testing; these exercises
duplicate the exercises described in the proposed ABQLFT protocol,
except that, as noted previously, the ANSI standard requires that the
test exercises last at least 30 seconds each.
H. Review of the Proposed Standard by the Advisory Committee for
Construction Safety and Health ("ACCSH")
By adding the ABQLFT as an optional qualitative fit-testing
protocol to Part I.B of Appendix A of OSHA's Respiratory Protection
Standard,\2\ this proposal would revise the fit-testing requirements
specified by that standard for the construction industry. Whenever the
Agency proposes a rulemaking that involves the occupational safety and
health of construction employees, OSHA's regulation governing the ACCSH
at 29 CFR 1912.3 requires the Agency to consult with the ACCSH. Having
provided the ACCSH members with copies of the proposal and other
relevant information several weeks before the regular meeting, OSHA
staff then met with them at the regular meeting on October 11, 2006. At
this meeting, OSHA staff discussed the proposal with, and answered
questions from, the ACCSH members. At their regular meeting the
following day (October 12, 2006), the ACCSH members recommended, by a
vote of nine in favor with one abstention, that OSHA publish the
proposal.
---------------------------------------------------------------------------
\2\ The Respiratory Protection Standard for the construction
industry at 29 CFR 1926.103 cross-references Respiratory Protection
Standard for general industry at 29 CFR 1910.134.
---------------------------------------------------------------------------
List of Subjects in 29 CFR Part 1910
Hazardous substances, Health, Occupational safety and health, Toxic
substances.
Authority and Signature
Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor, 200 Constitution Avenue,
NW., Washington, DC 20210, directed the preparation of this notice.
Accordingly, the Agency issues the proposed amendment under the
following authorities: Sections 4, 6(b), 8(c), and 8(g) of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657);
Section 3704 of the Contract Work Hours and Safety Standards Act (40
U.S.C. 3701 et seq.); Section 41 of the Longshore and Harbor Worker's
Compensation Act (33 U.S.C. 941); Secretary of Labor's Order No. 5-2007
(72 FR 31159); and 29 CFR part 1911.
Signed at Washington, DC on December 17, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
IV. Proposed Amendment to the Standard
For the reasons stated above in the preamble, the Agency proposes
to amend 29 CFR part 1910 as follows:
PART 1910--[AMENDED]
Subpart I--[AMENDED]
1. Revise the authority citation for subpart I of part 1910 to read
as follows:
Authority: Sections 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, and 657); Section 3704 of
the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et
seq.); Section 41, Longshore and Harbor Worker's Compensation Act
(33 U.S.C. 941); and Secretary of Labor's Order Nos. 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), or 5-2007 (72 FR 31159), as applicable.
Sections 29 CFR 1910.132, 1910.134, and 1910.138 also issued
under 29 CFR part 1911.
Sections 29 CFR 1910.133, 1910.135, and 1910.136 also issued
under 29 CFR part 1911 and 5 U.S.C. 553.
2. Amend section B.4(b)(8) of Appendix A to Sec. 1910.134 to read
as follows:
Sec. 1910.134 Respiratory protection.
* * * * *
Appendix A to Sec. 1910.134: Fit Testing Procedures (Mandatory)
* * * * *
B. * * *
4. * * *
(b) * * *
(8) After generating the aerosol, the employer shall:
(i) Instruct the test subject to perform the exercises specified
by section I.A.14 of this appendix; and
(ii) Ensure that the test subject performs each of these test
exercises for one minute; however, if the test subject is able to
detect the taste of the Bitrex® sensitivity screening
solution within the first 10 squeezes of the nebulizer bulb ("Level
1 sensitivity"), the employer may elect to have the test subject
perform each of the test exercises for a minimum of 15 seconds.
* * * * *
[FR Doc. E7-24792 Filed 12-21-07; 8:45 am]
BILLING CODE 4510-26-P
