Abbreviated Bitrex® Qualitative Fit-Testing Protocol, 72971-72976 [E7-24792]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Proposed Rules
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1910
[Docket No. OSHA–2007–0006]
RIN 1218–AC29
Abbreviated Bitrex Qualitative FitTesting Protocol
Occupational Safety and Health
Administration (OSHA); Labor.
ACTION: Notice of proposed rulemaking
and request for comments.
jlentini on PROD1PC65 with PROPOSALS
AGENCY:
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 informationcollection (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 https://
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
VerDate Aug<31>2005
17:22 Dec 21, 2007
Jkt 214001
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 https://
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 https://www.regulations.gov
or to the OSHA Docket Office at the
address above. Documents in the docket
are listed in the https://
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
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)
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
72971
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 https://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 fittesting 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
E:\FR\FM\26DEP1.SGM
26DEP1
72972
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Proposed Rules
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 fittesting (‘‘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 fittesting 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’’).
jlentini on PROD1PC65 with PROPOSALS
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
VerDate Aug<31>2005
17:22 Dec 21, 2007
Jkt 214001
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 fittesting exercises for 15 seconds (instead
of 60 seconds) while wearing a NIOSHcertified 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.
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
1 The test subjects did not perform the grimace
exercise.
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
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 fittesting 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 testsensitivity 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
E:\FR\FM\26DEP1.SGM
26DEP1
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Proposed Rules
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 logisticregression 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 logisticregression analysis results of testsensitivity values obtained for a popular
quantitative fit test and the existing 60second Bitrex qualitative fit test. The
authors conclude that the analysis
demonstrates that the distribution of fittesting 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.’’
jlentini on PROD1PC65 with PROPOSALS
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-andcomment rulemaking under Section
6(b)(7) of the OSH Act, and is initiating
this rulemaking to determine whether to
approve the proposed protocol for
VerDate Aug<31>2005
17:22 Dec 21, 2007
Jkt 214001
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 fittesting 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 fittesting 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 testsensitivity 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
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
72973
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 fittesting 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
E:\FR\FM\26DEP1.SGM
26DEP1
72974
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Proposed Rules
would reduce that risk, as typically
would be required by Industrial Union
Department, AFL–CIO v. American
Petroleum Institute, 448 U.S. 607 (1980).
jlentini on PROD1PC65 with PROPOSALS
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 fittesting 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 fittesting 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 fittesting 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
VerDate Aug<31>2005
17:22 Dec 21, 2007
Jkt 214001
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.
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
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 ‘‘Stateplan 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
E:\FR\FM\26DEP1.SGM
26DEP1
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Proposed Rules
jlentini on PROD1PC65 with PROPOSALS
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 OSHAapproved 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 OSHAapproved 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
VerDate Aug<31>2005
18:25 Dec 21, 2007
Jkt 214001
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
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
72975
addressed these protocols. However, the
American National Standards Institute
(ANSI) subsequently developed a
national consensus standard on fittesting 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 crossreferences Respiratory Protection Standard for
general industry at 29 CFR 1910.134.
E:\FR\FM\26DEP1.SGM
26DEP1
72976
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Proposed Rules
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.
jlentini on PROD1PC65 with PROPOSALS
2. Amend section B.4(b)(8) of
Appendix A to § 1910.134 to read as
follows:
§ 1910.134
Respiratory protection.
*
*
*
*
*
Appendix A to § 1910.134: Fit Testing
Procedures (Mandatory)
*
*
*
*
*
B. * * *
VerDate Aug<31>2005
17:22 Dec 21, 2007
Jkt 214001
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
DEPARTMENT OF EDUCATION
34 CFR Part 8
[Docket ID ED–2007–OS–0138]
Demands for Testimony or Records in
Legal Proceedings
Office of the Secretary,
Department of Education.
ACTION: Notice of proposed rulemaking.
AGENCY:
SUMMARY: The Secretary proposes to
amend the Department’s regulations
regarding the production of information
pursuant to demands in judicial or
administrative proceedings. The
changes are intended to promote
consistency in the Department’s
assertion of privileges and objections,
and thereby prevent harm that may
result from inappropriate disclosure of
confidential information or
inappropriate allocation of agency
resources. These changes would apply
only where employees are subpoenaed
in litigation to which the agency is not
a party. Former Department employees
would be expressly required to seek the
Secretary’s approval prior to responding
to subpoenas that seek non-public
materials and information acquired
during their employment at the
Department.
We must receive your comments
on or before February 25, 2008.
ADDRESSES: Submit your comments
through the Federal eRulemaking Portal
or via postal mail, commercial delivery,
or hand delivery. We will not accept
comments by fax or by e-mail. Please
submit your comments only one time, in
order to ensure that we do not receive
duplicate copies. In addition, please
include the Docket ID at the top of your
comments.
• Federal eRulemaking Portal: Go to
https://www.regulations.gov Under
DATES:
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
‘‘Search Documents’’ go to ‘‘Optional
Step 2’’ and select ‘‘Department of
Education’’ from the agency drop-down
menu; then click ‘‘Submit.’’ In the
Docket ID column, select ED–2007–OS–
0138 to add or view public comments
and to view supporting and related
materials available electronically.
Information on using
www.regulations.gov, including
instructions for submitting comments,
accessing documents, and viewing the
docket after the close of the comment
period, is available through the site’s
‘‘User Tips’’ link.
• Postal Mail, Commercial Delivery,
or Hand Delivery. If you mail or deliver
your comments about these proposed
regulations, address them to Christine
M. Rose, U.S. Department of Education,
400 Maryland Avenue, SW., Room
6C122, Washington, DC 20202–2110.
Privacy Note: The Department’s policy for
comments received from members of the
public (including those comments submitted
by mail, commercial delivery, or hand
delivery) is to make these submissions
available for public viewing in their entirety
on the Federal eRulemaking Portal at
https://www.regulations.gov. Therefore,
commenters should be careful to include in
their comments only information that they
wish to make publicly available on the
Internet.
FOR FURTHER INFORMATION CONTACT:
Christine M. Rose, Telephone: (202)
401–6700.
If you use a telecommunications
device for the deaf (TDD), you may call
the Federal Relay Service (FRS) at 1–
800–877–8339.
Individuals with disabilities can
obtain this document in an alternative
format (e.g., Braille, large print,
audiotape, or computer diskette) on
request to the contact person listed
under FOR FURTHER INFORMATION
CONTACT.
SUPPLEMENTARY INFORMATION:
Invitation to Comment
We invite you to submit comments
regarding these proposed regulations.
To ensure that your comments have
maximum effect in developing the final
regulations, we urge you to identify
clearly the specific section or sections of
the proposed regulations that each of
your comments addresses and to arrange
your comments in the same order as the
proposed regulations.
We invite you to assist us in
complying with the specific
requirements of Executive Order 12866
and its overall requirement of reducing
regulatory burden that might result from
these proposed regulations. Please let us
know of any further opportunities we
should take to reduce potential costs or
E:\FR\FM\26DEP1.SGM
26DEP1
]]>Agencies
[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Proposed Rules]
[Pages 72971-72976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24792]
[[Page 72971]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
https://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 https://
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 https://www.regulations.gov or to the OSHA Docket
Office at the address above. Documents in the docket are listed in the
https://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 https://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.
---------------------------------------------------------------------------
\1\ The test subjects did not perform the grimace exercise.
---------------------------------------------------------------------------
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
