Document ID: OSHA-2007-0006-0001
Agency: osha
Document Type: Proposed Rule
Title: Abbreviated Bitrex[supreg]Qualitative Fit-Testing Protocol
Posted Date: 2007-12-26T05:00Z

[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]                         

[[Page 72971]]

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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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] (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

[[Page 72972]]

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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] (referred to as the 
abbreviated Bitrex[supreg] 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[supreg] 
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[supreg] because they were able to taste the Bitrex[supreg] 
aerosol within 10 squeezes of the nebulizer bulb. Subjects having Level 
2 or 3 sensitivity to Bitrex[supreg] 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[supreg] sensitivity-screening test, the authors administered the 
ABQLFT using the procedures and techniques specified for the existing 
Bitrex[supreg] 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

[[Page 72973]]

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[supreg] 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[supreg] 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[supreg]. 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[supreg] 
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[supreg]?

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[supreg] 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

[[Page 72974]]

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[supreg] 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[supreg] 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[supreg] 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[supreg] 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[supreg] 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

[[Page 72975]]

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[supreg] 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[supreg] qualitative fit test, including 
requirements for administering the fit test; these requirements are 
consistent with the existing Bitrex[supreg] 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.

---------------------------------------------------------------------------

[[Page 72976]]

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[supreg] 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