Additional Quantitative Fit-Testing Protocols for the Respiratory Protection Standard, 3526-3534 [E9-922]
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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules
paragraph and § 1.861–12T(c)(2)) in the
stock of the redeeming corporation).
These adjustments are to be made
annually and are noncumulative.
(vii) Examples. Certain of the rules of
this paragraph (c)(2) may be illustrated
by the following examples:
Examples 1 and 2. [Reserved]. For
further guidance, see § 1.861–
12T(c)(2)(vii), Examples 1 and 2.
Example 3. X, an unaffiliated domestic
corporation that was organized on January 1,
2000, owns all of the stock of Y, a foreign
corporation with a functional currency other
than the U.S. dollar since January 1, 2000.
The Y stock held by X includes Class A and
Class B common stock. X’s adjusted basis in
the Class A and Class B common stock is
$25,000 and $50,000, respectively. Y has
earnings and profits for the 2008 taxable year
of $40,000. During the 2008 taxable year, Y
redeems all of the Class A common stock
held by X for $40,000. Because X still owns
all of the outstanding stock of Y, the
redemption is treated as a distribution with
respect to the stock of Y under section 301.
Under § 1.302–5(a)(3), X’s $ 25,000 adjusted
basis in the redeemed shares of Class A
common stock is treated as a loss recognized
on the date of the redemption, none of which
is taken into account in 2008. Under
paragraph (c)(2)(vi) of this section, solely for
purposes of apportioning expenses on the
basis of the tax book value of assets, X’s
adjusted basis in its remaining Class B
common stock of Y is considered to be
$75,000 ($50,000 adjusted basis in the Class
B common stock plus $ 25,000 unrecovered
basis in the redeemed Class A common
stock).
(c)(2)(viii) Effective/applicability date.
Paragraph (c)(2)(vi) and Example 3
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date these regulations are published as
final regulations in the Federal Register.
(c)(3) through (j) [Reserved]. For
further guidance, see § 1.861–12T(c)(3)
through (j).
§ 1.1002–1
[Redesignated as § 1.1001–6]
Par. 18. Section 1.1002–1 is
redesignated as 1.1001–6 and amended
by revising paragraph (c) and adding a
new paragraph (e) to read as follows:
§ 1.1001–6
Sales or exchanges.
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(c) Certain exceptions to general rule.
Exceptions to the general rule are made,
for example, by sections 351(a), 354,
361(a), 721, 1031, 1035, and 1036. These
sections describe certain specific
exchanges of property in which at the
time of the exchange particular
differences exist between the property
parted with and the property acquired,
but such differences are more formal
than substantial. As to these, the
Internal Revenue Code provides that
such differences shall not be deemed
controlling, and that gain or loss shall
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not be recognized at the time of the
exchange. The underlying assumption
of these exceptions is that the new
property is substantially a continuation
of the old investment still unliquidated;
and, in the case of reorganizations, that
the new enterprise, the new corporate
structure and the new property are
substantially continuations of the old
still unliquidated. Solely for purposes of
determining whether the exceptions to
the general rule under sections 354 and
361 apply to an exchange, to the extent
the terms of the exchange specify that a
particular property is received in
exchange for a particular property, such
terms shall control provided such terms
are economically reasonable.
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(e) Effective/applicability date. This
section applies to exchanges that occur
after the date these regulations are
published as final regulations in the
Federal Register. For exchanges that
occur on or before the date these
regulations are published as final
regulations in the Federal Register, see
this section as contained in 26 CFR part
1 revised April 1, for the year before
these regulations are published as final
regulations in the Federal Register.
Par. 19. Section 1.1016–2 is amended
by adding paragraphs (e) and (f) to read
as follows:
§ 1.1016–2 Items properly chargeable to
capital account.
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(e) Solely for purposes of determining
basis in stock, in the case of a
shareholder capital contribution to
which section 118 applies, the
principles of § 1.358–2(g)(3) (allocation
of basis in a section 351 transaction in
which stock is deemed received) shall
apply.
(f) This section applies to transactions
that occur after the date these
regulations are published as final
regulations in the Federal Register. For
exchanges that occur on or before the
date these regulations are published as
final regulations in the Federal Register,
see this section as contained in 26 CFR
part 1 revised April 1, for the year
before these regulations are published as
final regulations in the Federal Register.
Par. 20. Section 1.1374–10, the first
sentence of paragraph (a) is revised to
read as follows:
§ 1.1374–10
rules.
Effective date and additional
(a) In general. For transactions to
which § 1.302–5 applies [Reserved].
Sections 1.1374–1 through 1.1374–9,
other than § 1.1374–3(b) and (c)
Examples 2 through 4, apply for taxable
years ending on or after December 27,
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1994, but only in cases where the S
corporation’s return for the taxable year
is filed pursuant to an S election or a
section 1374(d)(8) transaction occurring
on or after December 27, 1994. * * *
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Linda M. Kroening,
(Acting) Deputy Commissioner for Services
and Enforcement.
[FR Doc. E9–1100 Filed 1–16–09; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1910
[Docket No. OSHA–2007–0007]
RIN 1218–AC39
Additional Quantitative Fit-Testing
Protocols for the Respiratory
Protection Standard
AGENCY: Occupational Safety and Health
Administration (OSHA); Labor.
ACTION: Notice of proposed rulemaking;
request for comments.
SUMMARY: OSHA is proposing to add
two PortaCount® quantitative fit-testing
protocols to its Respiratory Protection
Standard (29 CFR 1910.134); the
proposed protocols would apply to
employers in general industry, shipyard
employment, and the construction
industry. The first of the two proposed
protocols consists of the eight fit-testing
exercises described in Part I.A.14 of
Appendix A of the Respiratory
Protection Standard, except each
exercise would last 30 seconds instead
of the currently required 60 seconds.1
The second proposed protocol would
eliminate two of the eight fit-testing
exercises, and each of the remaining six
exercises would last 40 seconds; in
addition, this proposed protocol would
increase the current minimum pass-fail
fit-testing criterion from a fit factor of
100 to 200 for half masks, and from 500
to 1,000 for full facepieces.
DATES: Submit comments to this
proposal, including comments to the
information collection (paperwork)
determination described under the
section this preamble titled
SUPPLEMENTARY INFORMATION, as well as
1 Except for the grimace exercise, which currently
lasts 15 seconds and would remain at 15 seconds
in both of the proposed protocols. However, neither
the current nor proposed protocols include the fit
factor obtained from this exercise in determining
the overall fit factor for a respirator tested using a
quantitative fit test.
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other information, by March 23, 2009.
All submissions must bear a postmark
or provide other evidence of the
submission date. (See the following
section titled ADDRESSES for methods
used in submitting comments to the
docket.)
Submit comments,
identified by docket number OSHA–
2007–0007 or regulatory information
number (RIN) 1218–AC39, by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: (202) 693–1648 for comments
that are 10 pages or fewer in length
(including attachments). Instead of
transmitting facsimile copies of
attachments that supplement these
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
Avenue, NW., Washington, DC 20210.
These attachments must clearly identify
the sender’s name, date, subject, and
docket number or RIN number (i.e.,
OSHA–2007–0007 or 1218–AC39,
respectively) so that the Agency can
attach them to the appropriate
comments.
• Mail, Hand Delivery, or Courier (for
Paper, Disk, or CD–ROM Submissions):
OSHA Docket Office, Docket No.
OSHA–2007–0007 or RIN No. 1218–
AC39, Technical Data Center, Room N–
2625, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210; telephone: (202) 693–2350.
(OSHA’s TTY number is (877) 889–
5627.) 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 docket
number or RIN number (i.e., OSHA–
2007–0007 or 1218–AC39, respectively)
for this rulemaking. All comments
received will be posted without change
to https://www.regulations.gov, including
any personal information provided. For
detailed instruction on submitting
comments and additional information
on the rulemaking process, see the
‘‘Public Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
• Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and/or to the
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ADDRESSES:
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OSHA Docket Office in Room N–2625,
U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC. The https://www.regulations.gov
index lists the documents in the docket;
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:
• General information and press
inquiries: Contact Ms. Jennifer Ashley,
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.
• Technical inquiries: Contact Mr.
John 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: Electronic copies of this Federal
Register notice, news releases, and other
similar documents are available on
OSHA’s Web page at https://
www.osha.gov (select ‘‘Federal
Register,’’ ‘‘Date of Publication,’’ and
then ‘‘2008’’).
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 Authority
B. Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis
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
I. Public Participation
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 three quantitative fittesting protocols using the following
challenge agents: A non-hazardous
generated aerosol such as corn oil,
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polyethylene glycol 400, di-2-ethyl
hexyl sebacate, or sodium chloride;
ambient aerosol; and controlled negative
pressure. Appendix A of the Respiratory
Protection Standard also specifies the
procedure for adding new fit-testing
protocols to this standard. The criteria
for determining whether OSHA must
publish a fit-testing protocol for noticeand-comment rulemaking under Section
6(b)(7) of the Occupational Safety and
Health Act of 1970 (the ‘‘Act’’) (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 peerreviewed industrial-hygiene journal
describing the protocol and explaining
how the test data support the protocol’s
accuracy and reliability. Using this
procedure, OSHA has added one fittesting protocol (i.e., the controlled
negative pressure REDON quantitative
fit-testing protocol) to Appendix A of its
Respiratory Protection Standard (see 69
FR 46986).
II. Summary and Explanation of the
Proposal
A. Introduction
In the letter submitting two new
quantitative fit-testing protocols for
review under the provisions of
Appendix A of OSHA’s Respiratory
Protection Standard (Ex. OSHA–2007–
0007–0002), Mr. Jeff Weed of TSI Inc.
included a copy of a peer-reviewed
article from an industrial-hygiene
journal describing the accuracy and
reliability of these proposed protocols
(Ex. OSHA–2007–0007–0003).2 The
submission letter also included
instructions that described in detail the
equipment and procedures required to
administer the proposed protocols.
According to this description, the
proposed protocols are variations of the
existing ambient-aerosol condensationnuclei-counter quantitative fit-testing
protocol developed by TSI Inc., in the
1980’s, commonly referred to as the
standard PortaCount® quantitative fittesting protocol (hereafter, ‘‘the standard
PortaCount® QNFT protocol’’). OSHA
included the standard PortaCount®
QNFT protocol in Appendix A of its
final Respiratory Protection Standard.
2 This letter and the accompanying article
describe three fit-testing protocols, but Mr. Weed of
TSI Inc., in a subsequent telephone call to OSHA
staff, requested that the Agency include only two
of them in this proposed rulemaking.
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(For consistency, OSHA will refer to the
two proposed protocols as ‘‘revised
PortaCount® quantitative fit-testing
protocols 1 and 2’’ (i.e., ‘‘revised
PortaCount® QNFT protocols 1 and 2’’).
The proposed protocols use the same
fit-testing requirements and
instrumentation specified for the
standard PortaCount® QNFT protocol in
paragraphs (a) and (b) of Part I.C.3 of
Appendix A of the Respiratory
Protection Standard, with the following
exceptions:
• Revised PortaCount® QNFT
protocol 1 reduces the duration of the
eight fit-testing exercises from 60
seconds to 30 seconds; and
• Revised PortaCount® QNFT
protocol 2 eliminates two of the eight
fit-testing exercises, with each of the
remaining six exercises having a
duration of 40 seconds; in addition, this
proposed protocol increases the current
minimum pass-fail fit-testing criterion
from a fit factor of 100 to 200 for half
masks, and from 500 to 1,000 for full
facepieces.
B. Summary of the Peer-Reviewed
Article
Peer-reviewed industrial-hygiene
journal article. The peer-reviewed
article submitted by Mr. Jeff Weed of
TSI Inc., entitled ‘‘Evaluation of Three
New Fit Test Protocols for Use with the
TSI PortaCount,’’ appeared in the Fall/
Winter 2005 issue of the Journal of the
International Society for Respiratory
Protection (Ex. OSHA–2007–0007–
0003). This article describes a study that
determined whether performing the
proposed protocols yields fit-testing
results similar to results obtained with
the standard PortaCount® QNFT
protocol (i.e., the standard PortaCount®
QNFT protocol was the criterion
measure or ‘‘gold standard’’).
Test subjects and respirator selection.
The study involved 30 test subjects who
performed 140 fit tests while wearing
elastomeric half-mask and full-facepiece
respirators equipped with P100 filters.
The test subjects selected respirators
from among 24 models, with some test
subjects using more than one model
during fit testing. Respirator fit varied
across the test subjects, with 60 of 140
fit factors below 100, and 91 of 140 fit
factors less than 500, as determined by
the standard PortaCount® QNFT
protocol.3 Poor respirator fit resulted
from improper respirator selection by
the test subjects themselves, or from
assigning respirators to test subjects that
were either too small or too large. Test
subjects could adjust the respirator for
comfort, but they did not perform user
seal checks.
Procedures. In conducting the study,
the authors followed the
recommendations for evaluating new fit-
testing protocols specified by Annex A2
(‘‘Criteria for Evaluating Fit Tests
Methods’’) of ANSI Z88.10–2001
(‘‘Respirator Fit Testing Methods’’).
Specially designed testing software
allowed for calculation of fit factors
every 10 seconds during the in-mask
sampling periods without disturbing the
facepiece (i.e., at 10-, 20-, and 30-second
intervals for comparison with the 40second in-mask sampling intervals
determined using the standard
PortaCount® QNFT protocol). The
authors used TSI-supplied sampling
adaptors, or respirators with fixed
probes provided by the respirator
manufacturer, to collect samples inside
the respirators. The sampling point
inside the respirator was between the
nose and the mouth. During sampling,
the test subjects performed the exercises
listed in Part I.A.14 of Appendix A of
OSHA’s Respiratory Protection
Standard, which include: initial normal
breathing, deep breathing, turning the
head side to side, moving the head up
and down, reading a passage, grimace,
bending over, and final normal
breathing.
The TSI PortaCount® Plus fit-testing
instrument performed particle counts on
samples collected during the study. The
table below provides the exercise and
sampling parameters for each of the
protocols used in the study.
Number of
exercises
Protocol
Standard PortaCount® QNFT Protocol .......................................................................................
Revised PortaCount® QNFT Protocol 1 ......................................................................................
Revised PortaCount® QNFT Protocol 2 ......................................................................................
8
8
26
Duration of
each exercise
(secs.)
In-mask sampling duration
for each
exercise
(secs.) 1
60
30
40
40
10
20
1 Does
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2 This
not include 20 seconds for each exercise to collect ambient-air samples and to purge the in-mask and ambient-air sampling tubes.
protocol eliminated the initial normal-breathing exercise and the deep-breathing exercise.
Results. To pass a fit test using revised
PortaCount® QNFT protocol 1, test
subjects had to attain a fit factor of 100
for half masks and 500 for full-facepiece
respirators; the pass-fail criteria for fullfacepiece respirators using revised
PortaCount® QNFT protocol 2 were 200
for half masks and 1,000 for fullfacepiece respirators. Based on these
criteria, the authors determined the
following statistics for the two proposed
protocols: test sensitivity; predictive
value of a pass; test specificity;
predictive value of a fail; and the kappa
statistic. 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); D =
false negatives (failed the fit test with a
fit factor ≥ 100); Po = observed
proportion of the two fit tests that are
concordant; and Pe = expected
proportion of the two fit tests expected
to be concordant when the two tests are
statistically independent. 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; predictive value of a fail =
C/(C + D), RV > 0.50; and the kappa
statistic = (Po¥Pe)/(1¥Pe).
Using the standard PortaCount®
QNFT protocol as the criterion measure,
the variables for the two proposed
protocols had values for half masks and
full-facepiece respirators listed in the
following two tables.
3 After excluding from the analysis fit factors
within one standard deviation of the reference fit-
factor pass-fail criterion, these figures are 57 of 135
fit factors below 100, and 91 of 135 fit factors less
than 500.
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Values for half-mask respirators
Variables
Sensitivity .............................................................................................................
Predictive Value of a Pass ..................................................................................
Specificity .............................................................................................................
Predictive Value of a Fail ....................................................................................
Kappa Statistic .....................................................................................................
1=
2=
Revised
PortaCount®
QNFT Protocol 1
ANSI
requirement
≥0.95
≥0.95
>0.50
>0.50
>0.70
Revised
PortaCount®
QNFT Protocol 2
1 0.91
1.00
1.00
0.81
0.79
0.78
2 0.94
0.99
0.98
0.91
Fail.
Borderline fail.
Values for full-facepiece respirators
Variables
Sensitivity .............................................................................................................
Predictive Value of a Pass ..................................................................................
Specificity .............................................................................................................
Predictive Value of a Fail ....................................................................................
Kappa Statistic .....................................................................................................
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1=
Revised
PortaCount®
QNFT Protocol 1
ANSI
requirement
≥0.95
≥0.95
>0.50
>0.50
>0.70
0.97
1 0.94
0.98
0.99
0.94
Revised
PortaCount®
QNFT Protocol 2
1.00
1.00
0.84
0.92
0.87
Borderline fail.
For half masks, revised PortaCount®
QNFT protocol 1 failed to meet the
sensitivity value specified by ANSI
Z88.10–2001, and, consistent with this
failure, the value for the predictivevalue-of-a-pass variable was marginal.
However, for full-facepiece respirators,
the sensitivity value for this proposed
protocol exceeded the ANSI
requirement, although the predictivevalue-of-a-pass variable was again
slightly below the ANSI specification.
The failure of this proposed protocol to
attain an adequate sensitivity value
when applied to half masks indicates
that, for half masks, the proposed
protocol is susceptible to alpha, or false
positive, error—i.e., it would pass some
half masks that would function below a
fit factor of 100 when tested with the
protocol used as the criterion measure
(i.e., the standard PortaCount® QNFT
protocol). The authors did not provide
an explanation for this deficiency.
However, the deficiency is unlikely to
be the result of statistical error because
the number of test subjects appeared to
be adequate, and a procedural or
measurement error should have
decreased the sensitivity value for
revised PortaCount® QNFT protocol 2,
which was not the case. Despite these
problems, revised PortaCount® QNFT
protocol 1 performed well above the
values established by the ANSI standard
for the three remaining variables,
including specificity, predictive value of
a fail, and the kappa statistic. These
values indicate that the vast majority of
the test subjects who passed (or failed)
the criterion measure also passed (or
failed) the proposed protocol, and the
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proposed protocol correlated highly
with the criterion measure. Nonetheless,
the fact that revised PortaCount® QNFT
protocol 1 failed to meet the sensitivity
value specified by ANSI Z88.10–2001
for half masks raises the question of
whether it is as protective as the
standard PortaCount® QNFT protocol,
and OSHA has raised this as an issue for
public comment (see below).
The variables for revised PortaCount®
QNFT protocol 2 had sensitivity values
for both half masks and full-facepiece
respirators well in excess of the
sensitivity value specified by the ANSI
standard. The sensitivity values for this
proposed protocol demonstrate that it
identified 100% of the poorly fitting
half masks and full-facepiece
respirators. In addition, this proposed
protocol performed well above the
values listed in the ANSI standard for
the four remaining variables, including
predictive value of a pass, specificity,
predictive value of a fail, and the kappa
statistic. Consistent with the sensitivity
values derived for this proposed
protocol, these four values indicate that
the proposed protocol resulted in fit
factors that accurately identified half
masks and full-facepiece respirators
with acceptable and poor fits, and that
these fit factors agreed closely with the
fit factors attained from the criterion
measure.
In discussing the results for revised
PortaCount® QNFT protocol 2, the
authors noted that excluding the two
least strenuous fit-testing exercises (i.e.,
the initial normal-breathing exercise
and the deep-breathing exercise) from
this proposed protocol was a
conservative approach in that the
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proposed protocol was more likely than
protocols consisting of eight fit-testing
exercises to detect respirator leakage
(i.e., using data from less strenuous fittesting exercises inappropriately inflates
the overall fit factor for respirators,
thereby increasing alpha error). Another
conservative approach used by this
proposed protocol was raising the passfail criterion for half masks from a fit
factor of 100 to 200, and, for fullfacepiece respirators, from 500 to 1,000.
This approach likely enhanced the
sensitivity of the proposed protocol.
However, enhancing sensitivity may
increase beta (false-negative) error,
which would increase the number of
repeated tests and, consequently, the
total testing time required by some
employees to identify a respirator
having an acceptable fit.
C. Conclusions
OSHA believes that the information
submitted by Mr. Weed in support of
the proposed protocols meets the
criteria for determining whether OSHA
must publish fit-testing protocols for
notice-and-comment rulemaking
established by the Agency in Part II of
Appendix A of its Respiratory
Protection Standard. Therefore, the
Agency concludes that the proposed
protocols warrant notice-and-comment
rulemaking under Section 6(b)(7) of the
Act (29 U.S.C. 655), and is initiating this
rulemaking to determine whether to
approve these proposed protocols for
inclusion in Part I of Appendix A of its
Respiratory Protection Standard.
The only differences between the two
proposed protocols and the standard
PortaCount® QNFT protocol specified
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currently in Part I.C.3 of Appendix A of
the Respiratory Protection Standard are
the duration of the exercises used
during fit testing, and for revised
PortaCount® QNFT protocol 2, the
exclusion of the two least strenuous fittesting exercises and the raising of the
minimum passing criteria. Therefore,
the Agency is proposing to add the
proposed protocols to Part I.C.3 of
Appendix A (see section IV of this
preamble titled ‘‘Proposed Amendment
to the Standard’’). In addition to
decreasing exercise durations from 60
seconds to 30 or 40 seconds, the
proposed revisions to the regulatory text
would limit use of revised PortaCount®
QNFT protocol 2 to respirator users who
demonstrate a minimum passing criteria
of 200 for half masks or 1,000 for fullfacepiece respirators. If approved, the
proposed protocols would be
alternatives to the existing quantitative
fit-testing protocols already listed in the
Part I of Appendix A of the Respiratory
Protection Standard; employers would
be free to select these alternatives or to
continue using any of the other
protocols currently listed in the
appendix.
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D. Issues for Public Comment
OSHA invites comments and data
from the public regarding the accuracy
and reliability of the two proposed
protocols, their effectiveness in
detecting respirator leakage, and their
usefulness in selecting respirators that
will protect employees from airborne
contaminants in the workplace.
Specifically, the Agency invites public
comment on the following issues:
• Was the study described in the
peer-reviewed journal article well
controlled, and conducted according to
accepted experimental design practices
and principles?
• Were the results of the study
described in this article properly, fully,
and fairly presented and interpreted?
• Will the proposed protocols
generate reproducible fit-testing results?
• Will the proposed protocols reliably
identify respirators with unacceptable
fit as effectively as the quantitative fittesting protocols, including the standard
PortaCount® QNFT protocol, already
listed in Part I.C.3 of Appendix A of the
Respiratory Protection Standard?
• Is the test-sensitivity value of 0.91
obtained for half masks by revised
PortaCount® QNFT protocol 1
acceptable in view of the test-sensitivity
value of 0.95 required by ANSI Z88.10–
2001. If not, would it be appropriate for
OSHA to limit application of revised
PortaCount® QNFT protocol 1 to fullfacepiece respirators?
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• The study evaluating the proposed
protocols involved only elastomeric
half-mask and full-facepiece respirators.
Accordingly, is it appropriate to apply
the results of the study to other types of
respirators (e.g., filtering-facepiece
respirators)?
III. Procedural Determinations
A. Legal Authority
The purpose of the Occupational
Safety and Health Act of 1970 (‘‘the
Act’’; 29 U.S.C. 651 et seq.) is ‘‘to assure
so far as possible every working man
and woman in the nation safe and
healthful working conditions and to
preserve our human resources’’ (29
U.S.C. 651(b)). To achieve this goal,
Congress authorized the Secretary of
Labor to promulgate and enforce
occupational safety and health
standards (29 U.S.C. 655(b) and 654(b)).
Under the Act, 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 Act when it
substantially reduces or eliminates a
significant workplace risk, and is
technologically and economically
feasible, cost effective, consistent with
prior Agency action or supported by a
reasoned justification for departing from
prior Agency action, and supported by
substantial evidence; it also must
effectuate the Act’s purposes better than
any national consensus standard it
supersedes (see International Union,
UAW v. OSHA (LOTO II), 37 F.3d 665
(D.C. Cir. 1994); and 58 FR 16612–16616
(March 30, 1993)). Rules promulgated
by the Agency must be highly protective
(see 58 FR 16612, 16614–15 (March 30,
1993); LOTO II, 37 F.3d 665, 669 (D.C.
Cir. 1994)). Moreover, Section 8(g)(2) of
the Act authorizes OSHA ‘‘to prescribe
such rules and regulations as [it] may
deem necessary to carry out its
responsibilities under the Act’’ (see 29
U.S.C. 657(g)(2)).
Based on the available evidence,
OSHA has preliminarily determined
that the protocols described in the
proposed rule meet the legal
requirements to provide substantial
protection to employees who use
respirators when exposed to hazardous
atmospheres (see Industrial Union Dept.
v. American Petroleum Institute, 448
U.S. 607, 655 (1980); International
Union v. Pendergrass, 878 F.2d 389,
392–93 (DC Cir. 1989); Building and
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Construction Trades Dept., AFL-CIO v.
Brock, 838 F.2d 1258, 1264–65 (DC Cir.
1988)). OSHA also made a preliminary
finding that the proposed rule is
technologically feasible because the
protective measures it requires already
exist (see American Textile Mfrs.
Institute v. OSHA (Cotton Dust), 452
U.S. 490, 513 (1981); American Iron and
Steel Institute v. OSHA (Lead II), 939
F.2d 975, 980 (DC Cir. 1991)).
Specifically, 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. In this regard, for
OSHA to adopt the proposed protocols
in the final rule, OSHA would have to
determine that the proposed protocols
provide employees with protection that
is comparable to the protection afforded
to them by the provisions of the
standard PortaCount® QNFT protocol. If
adopted, the protocols would not
replace existing fit-testing protocols, but
instead would be alternatives to them.
Therefore, OSHA preliminarily finds
that the proposal would not directly
increase or decrease the protection
afforded to employees, nor would it
increase employers’ compliance
burdens. As demonstrated in the
following section, the proposal may
reduce employers’ compliance burdens
by decreasing the time required to fit
test respirators for employee use.
Accordingly, OSHA concludes that it is
unnecessary to determine significant
risk or the extent to which this proposal
would reduce that risk, as typically
would be required by Industrial Union
Department, AFL-CIO v. American
Petroleum Institute, 448 U.S. 607 (1980).
The Agency believes that the
proposed rule is economically feasible
because the employers can absorb or
pass on the costs of compliance without
threatening their long-term profitability
or competitive structure (see Cotton
Dust, 452 U.S. at 530 n. 55 (1981); Lead
II, 939 F.2d 975, 980 (DC Cir. 1991)).
Moreover, the preliminary economic
analysis of the proposed rule describes
the benefits and costs of the proposed
rule (see section III.B. of this preamble,
‘‘Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis’’).
Based on this information, OSHA made
a preliminary determination that the
proposed rule is an economically
feasible means of meeting its statutory
objective of reducing the risk associated
with employee exposure to hazardous
atmospheres while using respirators (see
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Cotton Dust, 453 U.S. at 514 n. 32
(1981); LOTO II, 37 F.3d 665, 668 (DC
Cir. 1994)).
B. Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis
The proposal is not economically
significant within the context of
Executive Order (‘‘E.O.’’) 12866 (58 FR
51735), or 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 a
significant or major rule specified by
E.O. 12866 or other relevant statutes.
The proposal offers employers
additional options to fit test their
employees for respirator use. In this
regard, OSHA would supplement the
standard PortaCount® QNFT protocol
currently in Appendix A of the
Respiratory Protection Standard with
the proposed protocols if it approves
them as a result of this proposed
rulemaking. According to a recent
survey of respirator use conducted by
the National Institute for Occupational
Safety and Health and the Bureau of
Labor Statistics, approximately 7,500
establishments currently use an
ambient-aerosol protocol out of nearly
282,000 establishments found by the
survey to require respirator use (Ex. 6–
3, Docket No. H049C (‘‘Respiratory
Protection—Assigned Protection
Factors’’).4
Under this proposal, employers
would have a choice between the
standard PortaCount® QNFT protocol
consisting of exercises lasting one
minute each, or the proposed protocols
with exercises (six or eight) lasting 30 or
40 seconds each. 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 protocols would be adopted
by some employers who currently use
the standard PortaCount® QNFT
protocol for their employees. These
employers would adopt the proposed
protocols because these protocols would
take less time to administer than the
standard PortaCount® QNFT protocol,
thereby decreasing the cost required for
fit testing their employees. However, the
Agency believes that the proposed
protocols are unlikely to be adopted by
employers who currently perform fit
testing using other quantitative or
qualitative fit tests because of the
4 The standard PortaCount® QNFT protocol is the
only ambient-aerosol protocol currently listed in
Appendix A of the Respiratory Protection Standard.
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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 quantitative 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 fittesting protocols already listed in Part I
of Appendix A of the Respiratory
Protection Standard, or implement the
proposed fit-testing protocols instead.
Therefore, using one of the proposed fittesting protocols 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.
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3531
D. Federalism
The Agency reviewed the proposal
according to the most recent Executive
Order (‘‘E.O.’’) on Federalism (E.O.
13132; 64 FR 43225). This E.O. 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. The E.O. allows Federal agencies
to preempt State law only with the
expressed consent of Congress. In such
cases, Federal agencies must limit
preemption of State law to the extent
possible.
Section 18 of the Act; 29 U.S.C. 651
et seq.), expressly provides OSHA with
authority to preempt State occupational
safety and health standards to the extent
that the Agency promulgates a Federal
standard under Section 6 of the Act.
Accordingly, Section 18 of the Act
authorizes the Agency to preempt State
promulgation and enforcement of
requirements dealing with occupational
safety and health issues covered by
OSHA standards unless the State has an
OSHA-approved occupational safety
and health plan (namely, is a ‘‘Stateplan State’’). (See Gade v. National
Solid Waste Management Association,
112 S. Ct. 2374 (1992).)
With respect to States that do not
have OSHA-approved plans, the Agency
concludes that this proposed rule
conforms to the preemption provisions
of the Act. Additionally, Section 18 of
the 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. Therefore, for States that do
not have approved occupational safety
and health plans, this proposed rule
would not affect the preemption
provisions of Section 18 of the Act.
OSHA has authority under E.O. 13132
to propose the use of additional fittesting protocols under its Respiratory
Protection Standard at 29 CFR 1910.134
because the problems addressed by
these fit-testing requirements are
national in scope. The Agency
preliminarily concludes that the fittesting protocols proposed by this
rulemaking would provide employers in
every State with procedures that would
assist them in protecting their
employees from the risks of exposure to
atmospheric hazards. In this regard, the
proposal offers thousands of employers
across the nation an opportunity to use
additional protocols to assess respirator
fit among their employees. Therefore,
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the proposal would provide employers
in every State with an alternative means
of complying with the fit-testing
requirements specified by 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 Act (29 U.S.C. 667(c)(2))
requires State-plan States to adopt the
same standard, or to develop and
enforce an alternative standard that is at
least as effective as the OSHA standard.
However, the new fit-testing protocols
proposed in this rulemaking would only
provide employers with an alternative
to the existing requirements for fittesting 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 proposed rulemaking. Nevertheless,
OSHA strongly encourages them to
adopt the final provisions to provide
additional compliance options to
employers in their States.
In summary, this proposed rule
complies with E.O. 13132. In States
without OSHA-approved State Plans,
Congress expressly provides for OSHA
standards to preempt State job safety
and health rules in areas addressed by
the Federal standards; in these States,
this proposed rule would limit State
policy options in the same manner as
every standard promulgated by the
Agency. In States with OSHA-approved
State Plans, this rulemaking does not
significantly limit State policy options.
E. State-Plan States
Section 18(c)(2) of the Act (29 U.S.C.
667(c)(2)) requires State-Plan States to
adopt mandatory standards promulgated
by OSHA. However, as noted in the
previous section of this preamble, States
with OSHA-approved State Plans would
not be obligated to adopt the final
provisions that may result from this
proposed rulemaking. Nevertheless,
OSHA strongly encourages them to
adopt the final provisions to provide
compliance options to employers in
their States. In this regard, OSHA
preliminarily concludes that the fittesting protocols proposed by this
rulemaking would provide employers in
the State-Plan States with procedures
that would protect the safety and health
of employees who use respirators
against hazardous airborne substances
in their workplace at least as well as the
standard PortaCount® QNFT protocol.
The 24 States and two Territories with
State Plans are: Alaska, Arizona,
California, Hawaii, Indiana, Iowa,
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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
(58 FR 58093). As discussed above in
section III.B of this preamble
(‘‘Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis’’),
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-sector
employers; therefore, this proposal is
not a significant regulatory action
within the meaning of Section 202 of
the UMRA (2 U.S.C. 1532).
Under voluntary agreement with
OSHA, some States enforce compliance
with their State standards on publicsector entities, and these agreements
specify that these State standards must
be equivalent to OSHA standards. Thus,
although OSHA preliminarily concludes
that the proposed protocols would
impose no additional costs on publicsector employers, the proposal would
not involve any unfunded mandates
imposed on any other State or local
government entity. 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
preliminarily certifies that this proposal
does not mandate that State, local, or
tribal governments adopt new,
unfunded regulatory obligations, nor
does the proposed rule increase
expenditures by the private sector of
more than $100 million a year.
G. Applicability of Existing Consensus
Standards
Section 6(b)(8) of the Act (29 U.S.C.
655(b(8)) requires OSHA to explain
‘‘why a rule promulgated by the
Secretary differs substantially from an
existing national consensus standard,’’
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by publishing ‘‘a statement of the
reasons why the rule as adopted will
better effectuate the purposes of the Act
than the national consensus standard.’’
In this regard, 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.
Later, the American National Standards
Institute (ANSI) 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 7.2 of ANSI Z88.10–2001
specifies the requirements for
conducting a PortaCount® quantitative
fit test, which differ substantially from
the standard PortaCount® QNFT
protocol provided in Part I.C.3 of
OSHA’s Respiratory Protection
Standard. These protocols differ in
terms of the fit-testing exercises
required, and the duration of these
exercises. In addition, the ANSI
standard provides no data or
information on the accuracy and
reliability of its protocol. The Agency
believes that limiting fit-testing options
to the protocol currently specified by
the ANSI standard would seriously
impede the development of fit-testing
protocols that are more accurate and
reliable, and less costly to administer,
than the ANSI protocol.
H. Advisory Committee for Construction
Safety and Health Review of the
Proposed Standard
The proposal to add two quantitative
fit-testing protocols to Part I.C of
Appendix A of OSHA’s Respiratory
Protection Standard would affect the
construction industry because it revises
the fit-testing requirements specified by
the standard, which is applicable to the
construction industry.5 Whenever the
Agency proposes a rule involving
construction activities, the Contract
Work Hours and Safety Standards Act
(Construction Safety Act) (40 U.S.C.
3704), OSHA regulations governing the
Advisory Committee for Construction
Safety and Health (ACCSH) (i.e., 29 CFR
1912.3), and provisions governing
OSHA rulemaking (i.e., 29 CFR 1911.10)
require OSHA to consult with the
ACCSH. Specifically, 29 CFR 1911.10
requires that the Assistant Secretary
provide the ACCSH with ‘‘any proposal
5 The Respiratory Protection Standard for the
construction industry at 29 CFR 1926.103 crossreferences the Respiratory Protection Standard for
general industry at 29 CFR 1910.134.
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of his own,’’ together with ‘‘all pertinent
factual information available to him,
including the results of research,
demonstrations, and experiments.’’
Accordingly, OSHA provided the
ACCSH members with copies of the
proposal and other relevant information
several weeks before the January 24,
2008, ACCSH meeting. OSHA staff met
with the ACCSH at that meeting to
discuss the proposal, and to answer
members’ questions about it. At the end
of this session, the ACCSH voted to
defer making any recommendations to
OSHA regarding the proposal until their
next meeting so they could thoroughly
review the proposal and the other
relevant information, including the
peer-reviewed article described above
under section II.B of this notice
(‘‘Summary of the Peer-Reviewed
Article’’).
At the May 16, 2008, ACCSH meeting,
OSHA staff again met with the ACCSH
to discuss the proposal. Following this
discussion, the ACCSH recommended
unanimously that OSHA: (1) Remove
the PortaCount® QNFT protocol 1 from
the proposal because it failed to meet
the ANSI Z88.10–2001 criteria for test
sensitivity and predicted value of a
pass; and (2) include the PortaCount®
QNFT protocol 2 in the proposal
because it met all of the ANSI Z88.10–
2001 criteria.
I. Public Participation
OSHA encourages members of the
public to participate in this rulemaking
by submitting comments on the
proposal, as well as documentary
evidence in support of these comments.
Accordingly, the Agency invites
interested parties having knowledge of,
or experience with, respirator fit-testing
protocols to participate in this process,
and welcomes any pertinent
information that will provide it with the
best available evidence on which to
develop the final regulatory provisions.
The Agency invites interested parties to
submit written views, arguments, and
data concerning this proposed rule,
including: responses to the issues
specified under section II.B of this
preamble (‘‘Issues for Public
Comment’’), and comments on OSHA’s
determination of the economic or other
regulatory impacts of the proposed rule
on the regulated community. Comments
may be submitted in response to this
Federal Register notice: (1)
Electronically at https://
www.regulations.gov, which is the
Federal eRulemaking portal; (2) by
facsimile (fax); or (3) by hard copy.
When submitting comments, follow the
procedures specified above in the
sections of this preamble titled DATES
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and ADDRESSES. All comments,
attachments, and other material must
identify the Agency name and the
OSHA docket number for this
rulemaking (Docket No. OSHA–2007–
0007). In addition, comments must
clearly identify the provision of the
proposal being addressed, the position
taken with respect to an issue, and the
basis for that position. Comments, along
with supporting data and references,
received by the end of the specified
comment period will become part of the
proceedings record. This material,
including comments, is available for
public inspection without change at
https://www.regulations.gov 6 and at
OSHA’s docket Web site at https://
www.dockets.osha.gov (under Docket
No. OSHA–2007–0007). Therefore,
OSHA cautions commenters about
submitting personal information such as
social security numbers and birth dates
with their comments. Exhibits
referenced in this Federal Register
notice also will be available at https://
www.regulations.gov and https://
www.dockets.osha.gov under the same
docket number.
Material that supplements electronic
comments may be uploaded
electronically (including by fax).
Supplemental material also may be
mailed to the OSHA Docket Office (see
the section of this preamble titled
ADDRESSES) provided it identifies the
electronic comments using the
commenter’s name, comment
submission date, and docket number so
OSHA can attach the materials to the
appropriate comments. Reading or
downloading some of this material (e.g.,
copyrighted material) from the https://
www.regulations.gov and https://
www.dockets.osha.gov Web sites is not
possible; however, this material is
available for inspection and copying
(along with comments and exhibits) at
the OSHA Docket Office (see the section
of this preamble titled ADDRESSES).
Security-related procedures may
delay significantly the delivery of
comments and other material submitted
through the regular mail. For
information about security procedures
involving the regular mail, as well as
express delivery and messenger or
courier service, contact the OSHA
Docket Office at (202) 693–2350 (TTY
(877) 889–5627).
Electronic copies of this Federal
Register notice are available at https://
www.regulations.gov. This notice, as
well as news releases and other relevant
6 Information on using this Web site to submit
comments and to access dockets is available at the
Web site’s ‘‘User Tips’’ link. Contact the OSHA
Docket Office for information and assistance about
using the Internet to locate docket submissions.
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3533
information, also are available at
OSHA’s Web site at https://
www.osha.gov.
List of Subjects in 29 CFR Part 1910
Fit testing, Hazardous substances,
Health, Occupational safety and health,
Respirators, Toxic substances.
Authority and Signature
Thomas M. Stohler, Acting 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 January 13,
2009.
Thomas M. Stohler,
Acting 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), 5–2002 (67 FR 65008), 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. Add paragraphs (c) and (d) to
section C.3 of Appendix A to § 1910.134
to read as follows:
§ 1910.134
Respiratory protection.
*
*
E:\FR\FM\21JAP1.SGM
*
21JAP1
*
*
3534
Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Proposed Rules
(c) Revised PortaCount® Quantitative FitTesting Protocol 1.
(1) When administrating this protocol to
test subjects (i.e., employees), employers
must comply with the requirements specified
in paragraphs (a) and (b) of Part 1.C.3 of this
appendix. In addition, employers must use
the eight fit-testing exercises specified in
*
*
*
*
*
*
*
*
*
*
C. * * *
*
*
3. * * *
*
*
Overall Fit Factor =
Note to Paragraph (c)(2): Only seven of the
eight fit-testing exercises are used in this
calculation because the results for the
grimace exercise (ff6) are not included in the
calculation.
(d) Revised PortaCount® Quantitative FitTesting Protocol 2.
(1) When administrating this protocol to
test subjects (i.e., employees), employers
must comply with the requirements specified
in paragraphs (a) and (b) of Part 1.C.3 of this
7
1/ff1 + 1/ff 2 + 1/ff3 + 1/ff 4 + 1/ff5 + 1/ff 7 + 1/ff8
appendix. In addition, employers must use
the fit-testing exercises specified in section
I.A.14 of this appendix when administering
this protocol, except that test subjects must
not perform the fit-testing exercises specified
by paragraphs (a)(1) and (a)(2) of section
I.A.14 (i.e., the initial normal-breathing
exercise and the deep-breathing exercise,
respectively). Test subjects must perform
these fit-testing exercises for at least 40
seconds, except for the grimace exercise,
Overall Fit Factor =
Note to Paragraph (d)(3): Only five of the
eight fit-testing exercises are used in this
calculation because test subjects do not
perform the initial normal-breathing exercise
(ff1) and the deep-breathing exercise (ff2), and
the results for the grimace exercise (ff6) are
not included in the calculation.
*
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*
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*
[FR Doc. E9–922 Filed 1–16–09; 8:45 am]
BILLING CODE 4510–26–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 160, 161, 164, and 165
[USCG–2005–21869]
RIN 1625–AA99
Vessel Requirements for Notices of
Arrival and Departure, and Automatic
Identification System
Coast Guard, DHS.
Notice of public meeting;
request for comments.
AGENCY:
mstockstill on PROD1PC66 with PROPOSALS
ACTION:
SUMMARY: The Coast Guard announces a
public meeting to receive comments on
a notice of proposed rulemaking to
amend Coast Guard regulations
governing Notice of Arrival and
Departure (NOAD) and Automatic
Identification System (AIS)
requirements.
VerDate Nov<24>2008
18:22 Jan 16, 2009
Jkt 217001
5
1/ff3 + 1/ff 4 + 1/ff5 + 1/ff 7 + 1/ff8
DATES: A public meeting will be held on
March 5, 2009, from 12:30 p.m. to 3
p.m. to provide an opportunity for oral
comments. Written comments and
related material may also be submitted
to Coast Guard personnel specified at
that meeting. The comment period for
the proposed rule closes April 15, 2009.
All comments and related material
submitted after the meeting must either
be submitted to our online docket via
https://www.regulations.gov on or before
April 15, 2009, or reach the Docket
Management Facility by that date.
ADDRESSES: The public meeting will be
held at the United States Coast Guard
Headquarters Building, Room 2415,
2100 2nd Street, SW., Washington, DC
20593; a government-issued photo
identification (for example, a driver’s
license) will be required for entrance to
the building.
You may submit written comments
identified by docket number USCG–
2005–21869 before or after the meeting
using any one of the following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE, Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
PO 00000
Frm 00085
which test subjects must perform for 15
seconds.
(2) This protocol requires the following
minimum pass-fail fit-testing criteria: for half
masks, an overall fit factor of 200 (instead of
the usual 100); and, for full-facepiece
respirators, an overall fit factor of 1,000
(instead of the usual 500).
(3) Calculate the overall fit factor for this
protocol as follows:
Fmt 4702
Sfmt 4702
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. Our online
docket for this rulemaking is available
on the Internet at https://
www.regulations.gov under docket
number USCG–2005–21869.
FOR FURTHER INFORMATION CONTACT: If
you have questions concerning the
NOAD portion of this proposed
rulemaking or concerning the public
meeting, please contact Lieutenant
Sharmine Jones, Office of Vessel
Activities (CG–543), Coast Guard,
Sharmine.N.Jones@uscg.mil, telephone
202–372–1234. If you have questions on
the AIS portion of this proposed
rulemaking, contact Mr. Jorge Arroyo,
Office of Navigation Systems (CG–5413),
Coast Guard, Jorge.Arroyo@uscg.mil,
telephone 202–372–1563. If you have
questions on viewing or submitting
material to the docket, call Ms. Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Background and Purpose
We published a notice of proposed
rulemaking (NPRM) in the Federal
Register on December 16, 2008 (73 FR
76295), entitled ‘‘Vessel Requirements
for Notices of Arrival and Departure,
and Automatic Identification System.’’
In it we stated our intention to hold a
public meeting, and to publish a notice
E:\FR\FM\21JAP1.SGM
21JAP1
EP21JA09.122</GPH>
*
section I.A.14 of this appendix when
administering this protocol. Test subjects
must perform these fit-testing exercises for at
least 30 seconds, except for the grimace
exercise, which test subjects must perform
for 15 seconds.
(2) Calculate the overall fit factor for this
protocol as follows:
EP21JA09.126</GPH>
Appendix A to § 1910.134: Fit Testing
Procedures (Mandatory)
]]>Agencies
[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Proposed Rules]
[Pages 3526-3534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-922]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2007-0007]
RIN 1218-AC39
Additional Quantitative Fit-Testing Protocols for the Respiratory
Protection Standard
AGENCY: Occupational Safety and Health Administration (OSHA); Labor.
ACTION: Notice of proposed rulemaking; request for comments.
-----------------------------------------------------------------------
SUMMARY: OSHA is proposing to add two PortaCount[supreg] quantitative
fit-testing protocols to its Respiratory Protection Standard (29 CFR
1910.134); the proposed protocols would apply to employers in general
industry, shipyard employment, and the construction industry. The first
of the two proposed protocols consists of the eight fit-testing
exercises described in Part I.A.14 of Appendix A of the Respiratory
Protection Standard, except each exercise would last 30 seconds instead
of the currently required 60 seconds.\1\ The second proposed protocol
would eliminate two of the eight fit-testing exercises, and each of the
remaining six exercises would last 40 seconds; in addition, this
proposed protocol would increase the current minimum pass-fail fit-
testing criterion from a fit factor of 100 to 200 for half masks, and
from 500 to 1,000 for full facepieces.
---------------------------------------------------------------------------
\1\ Except for the grimace exercise, which currently lasts 15
seconds and would remain at 15 seconds in both of the proposed
protocols. However, neither the current nor proposed protocols
include the fit factor obtained from this exercise in determining
the overall fit factor for a respirator tested using a quantitative
fit test.
DATES: Submit comments to this proposal, including comments to the
information collection (paperwork) determination described under the
section this preamble titled SUPPLEMENTARY INFORMATION, as well as
[[Page 3527]]
other information, by March 23, 2009. All submissions must bear a
postmark or provide other evidence of the submission date. (See the
following section titled ADDRESSES for methods used in submitting
---------------------------------------------------------------------------
comments to the docket.)
ADDRESSES: Submit comments, identified by docket number OSHA-2007-0007
or regulatory information number (RIN) 1218-AC39, by any of the
following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Fax: (202) 693-1648 for comments that are 10 pages or
fewer in length (including attachments). Instead of transmitting
facsimile copies of attachments that supplement these 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 Avenue,
NW., Washington, DC 20210. These attachments must clearly identify the
sender's name, date, subject, and docket number or RIN number (i.e.,
OSHA-2007-0007 or 1218-AC39, respectively) so that the Agency can
attach them to the appropriate comments.
Mail, Hand Delivery, or Courier (for Paper, Disk, or CD-
ROM Submissions): OSHA Docket Office, Docket No. OSHA-2007-0007 or RIN
No. 1218-AC39, Technical Data Center, Room N-2625, U.S. Department of
Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone:
(202) 693-2350. (OSHA's TTY number is (877) 889-5627.) 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 docket number or RIN number (i.e., OSHA-2007-0007 or 1218-AC39,
respectively) for this rulemaking. All comments received will be posted
without change to https://www.regulations.gov, including any personal
information provided. For detailed instruction on submitting comments
and additional information on the rulemaking process, see the ``Public
Participation'' heading of the SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to read background
documents or comments received, go to https://www.regulations.gov and/or
to the OSHA Docket Office in Room N-2625, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC. The https://
www.regulations.gov index lists the documents in the docket; 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:
General information and press inquiries: Contact Ms.
Jennifer Ashley, 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.
Technical inquiries: Contact Mr. John 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: Electronic copies
of this Federal Register notice, news releases, and other similar
documents are available on OSHA's Web page at https://www.osha.gov
(select ``Federal Register,'' ``Date of Publication,'' and then
``2008'').
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 Authority
B. Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis
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
I. Public Participation
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 three quantitative fit-testing protocols
using the following challenge agents: A non-hazardous generated aerosol
such as corn oil, polyethylene glycol 400, di-2-ethyl hexyl sebacate,
or sodium chloride; ambient aerosol; and controlled negative pressure.
Appendix A of the Respiratory Protection Standard also specifies the
procedure for adding new fit-testing 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 (the ``Act'') (29 U.S.C.
655) include: (1) A test report prepared by an independent government
research laboratory (e.g., Lawrence Livermore National Laboratory, Los
Alamos National Laboratory, the National Institute for Standards and
Technology) stating that the laboratory tested the protocol and found
it to be accurate and reliable; or (2) an article published in a peer-
reviewed industrial-hygiene journal describing the protocol and
explaining how the test data support the protocol's accuracy and
reliability. Using this procedure, OSHA has added one fit-testing
protocol (i.e., the controlled negative pressure REDON quantitative
fit-testing protocol) to Appendix A of its Respiratory Protection
Standard (see 69 FR 46986).
II. Summary and Explanation of the Proposal
A. Introduction
In the letter submitting two new quantitative fit-testing protocols
for review under the provisions of Appendix A of OSHA's Respiratory
Protection Standard (Ex. OSHA-2007-0007-0002), Mr. Jeff Weed of TSI
Inc. included a copy of a peer-reviewed article from an industrial-
hygiene journal describing the accuracy and reliability of these
proposed protocols (Ex. OSHA-2007-0007-0003).\2\ The submission letter
also included instructions that described in detail the equipment and
procedures required to administer the proposed protocols. According to
this description, the proposed protocols are variations of the existing
ambient-aerosol condensation-nuclei-counter quantitative fit-testing
protocol developed by TSI Inc., in the 1980's, commonly referred to as
the standard PortaCount[supreg] quantitative fit-testing protocol
(hereafter, ``the standard PortaCount[supreg] QNFT protocol''). OSHA
included the standard PortaCount[supreg] QNFT protocol in Appendix A of
its final Respiratory Protection Standard.
[[Page 3528]]
(For consistency, OSHA will refer to the two proposed protocols as
``revised PortaCount[supreg] quantitative fit-testing protocols 1 and
2'' (i.e., ``revised PortaCount[supreg] QNFT protocols 1 and 2'').
---------------------------------------------------------------------------
\2\ This letter and the accompanying article describe three fit-
testing protocols, but Mr. Weed of TSI Inc., in a subsequent
telephone call to OSHA staff, requested that the Agency include only
two of them in this proposed rulemaking.
---------------------------------------------------------------------------
The proposed protocols use the same fit-testing requirements and
instrumentation specified for the standard PortaCount[supreg] QNFT
protocol in paragraphs (a) and (b) of Part I.C.3 of Appendix A of the
Respiratory Protection Standard, with the following exceptions:
Revised PortaCount[supreg] QNFT protocol 1 reduces the
duration of the eight fit-testing exercises from 60 seconds to 30
seconds; and
Revised PortaCount[supreg] QNFT protocol 2 eliminates two
of the eight fit-testing exercises, with each of the remaining six
exercises having a duration of 40 seconds; in addition, this proposed
protocol increases the current minimum pass-fail fit-testing criterion
from a fit factor of 100 to 200 for half masks, and from 500 to 1,000
for full facepieces.
B. Summary of the Peer-Reviewed Article
Peer-reviewed industrial-hygiene journal article. The peer-reviewed
article submitted by Mr. Jeff Weed of TSI Inc., entitled ``Evaluation
of Three New Fit Test Protocols for Use with the TSI PortaCount,''
appeared in the Fall/Winter 2005 issue of the Journal of the
International Society for Respiratory Protection (Ex. OSHA-2007-0007-
0003). This article describes a study that determined whether
performing the proposed protocols yields fit-testing results similar to
results obtained with the standard PortaCount[supreg] QNFT protocol
(i.e., the standard PortaCount[supreg] QNFT protocol was the criterion
measure or ``gold standard'').
Test subjects and respirator selection. The study involved 30 test
subjects who performed 140 fit tests while wearing elastomeric half-
mask and full-facepiece respirators equipped with P100 filters. The
test subjects selected respirators from among 24 models, with some test
subjects using more than one model during fit testing. Respirator fit
varied across the test subjects, with 60 of 140 fit factors below 100,
and 91 of 140 fit factors less than 500, as determined by the standard
PortaCount[supreg] QNFT protocol.\3\ Poor respirator fit resulted from
improper respirator selection by the test subjects themselves, or from
assigning respirators to test subjects that were either too small or
too large. Test subjects could adjust the respirator for comfort, but
they did not perform user seal checks.
---------------------------------------------------------------------------
\3\ After excluding from the analysis fit factors within one
standard deviation of the reference fit-factor pass-fail criterion,
these figures are 57 of 135 fit factors below 100, and 91 of 135 fit
factors less than 500.
---------------------------------------------------------------------------
Procedures. In conducting the study, the authors followed the
recommendations for evaluating new fit-testing protocols specified by
Annex A2 (``Criteria for Evaluating Fit Tests Methods'') of ANSI
Z88.10-2001 (``Respirator Fit Testing Methods''). Specially designed
testing software allowed for calculation of fit factors every 10
seconds during the in-mask sampling periods without disturbing the
facepiece (i.e., at 10-, 20-, and 30-second intervals for comparison
with the 40-second in-mask sampling intervals determined using the
standard PortaCount[supreg] QNFT protocol). The authors used TSI-
supplied sampling adaptors, or respirators with fixed probes provided
by the respirator manufacturer, to collect samples inside the
respirators. The sampling point inside the respirator was between the
nose and the mouth. During sampling, the test subjects performed the
exercises listed in Part I.A.14 of Appendix A of OSHA's Respiratory
Protection Standard, which include: initial normal breathing, deep
breathing, turning the head side to side, moving the head up and down,
reading a passage, grimace, bending over, and final normal breathing.
The TSI PortaCount[supreg] Plus fit-testing instrument performed
particle counts on samples collected during the study. The table below
provides the exercise and sampling parameters for each of the protocols
used in the study.
----------------------------------------------------------------------------------------------------------------
In-mask
Duration of sampling
Protocol Number of each exercise duration for
exercises (secs.) each exercise
(secs.) \1\
----------------------------------------------------------------------------------------------------------------
Standard PortaCount[supreg] QNFT Protocol....................... 8 60 40
Revised PortaCount[supreg] QNFT Protocol 1...................... 8 30 10
Revised PortaCount[supreg] QNFT Protocol 2...................... \2\ 6 40 20
----------------------------------------------------------------------------------------------------------------
\1\ Does not include 20 seconds for each exercise to collect ambient-air samples and to purge the in-mask and
ambient-air sampling tubes.
\2\ This protocol eliminated the initial normal-breathing exercise and the deep-breathing exercise.
Results. To pass a fit test using revised PortaCount[supreg] QNFT
protocol 1, test subjects had to attain a fit factor of 100 for half
masks and 500 for full-facepiece respirators; the pass-fail criteria
for full-facepiece respirators using revised PortaCount[supreg] QNFT
protocol 2 were 200 for half masks and 1,000 for full-facepiece
respirators. Based on these criteria, the authors determined the
following statistics for the two proposed protocols: test sensitivity;
predictive value of a pass; test specificity; predictive value of a
fail; and the kappa statistic. 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); D = false
negatives (failed the fit test with a fit factor >= 100); Po
= observed proportion of the two fit tests that are concordant; and
Pe = expected proportion of the two fit tests expected to be
concordant when the two tests are statistically independent. 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; predictive value of a fail =
C/(C + D), RV > 0.50; and the kappa statistic = (Po-
Pe)/(1-Pe).
Using the standard PortaCount[supreg] QNFT protocol as the
criterion measure, the variables for the two proposed protocols had
values for half masks and full-facepiece respirators listed in the
following two tables.
[[Page 3529]]
----------------------------------------------------------------------------------------------------------------
Values for half-mask respirators
-----------------------------------------------------------
Variables Revised Revised
ANSI requirement PortaCount[supreg] PortaCount[supreg]
QNFT Protocol 1 QNFT Protocol 2
----------------------------------------------------------------------------------------------
Sensitivity....................... >=0.95 \1\ 0.91 1.00
Predictive Value of a Pass........ >=0.95 \2\ 0.94 1.00
Specificity....................... >0.50 0.99 0.81
Predictive Value of a Fail........ >0.50 0.98 0.79
Kappa Statistic................... >0.70 0.91 0.78
----------------------------------------------------------------------------------------------------------------
\1\ = Fail.
\2\ = Borderline fail.
----------------------------------------------------------------------------------------------------------------
Values for full-facepiece respirators
-----------------------------------------------------------
Variables Revised Revised
ANSI requirement PortaCount[supreg] PortaCount[supreg]
QNFT Protocol 1 QNFT Protocol 2
----------------------------------------------------------------------------------------------
Sensitivity....................... >=0.95 0.97 1.00
Predictive Value of a Pass........ >=0.95 \1\ 0.94 1.00
Specificity....................... >0.50 0.98 0.84
Predictive Value of a Fail........ >0.50 0.99 0.92
Kappa Statistic................... >0.70 0.94 0.87
----------------------------------------------------------------------------------------------------------------
\1\ = Borderline fail.
For half masks, revised PortaCount[supreg] QNFT protocol 1 failed
to meet the sensitivity value specified by ANSI Z88.10-2001, and,
consistent with this failure, the value for the predictive-value-of-a-
pass variable was marginal. However, for full-facepiece respirators,
the sensitivity value for this proposed protocol exceeded the ANSI
requirement, although the predictive-value-of-a-pass variable was again
slightly below the ANSI specification. The failure of this proposed
protocol to attain an adequate sensitivity value when applied to half
masks indicates that, for half masks, the proposed protocol is
susceptible to alpha, or false positive, error--i.e., it would pass
some half masks that would function below a fit factor of 100 when
tested with the protocol used as the criterion measure (i.e., the
standard PortaCount[supreg] QNFT protocol). The authors did not provide
an explanation for this deficiency. However, the deficiency is unlikely
to be the result of statistical error because the number of test
subjects appeared to be adequate, and a procedural or measurement error
should have decreased the sensitivity value for revised
PortaCount[supreg] QNFT protocol 2, which was not the case. Despite
these problems, revised PortaCount[supreg] QNFT protocol 1 performed
well above the values established by the ANSI standard for the three
remaining variables, including specificity, predictive value of a fail,
and the kappa statistic. These values indicate that the vast majority
of the test subjects who passed (or failed) the criterion measure also
passed (or failed) the proposed protocol, and the proposed protocol
correlated highly with the criterion measure. Nonetheless, the fact
that revised PortaCount[supreg] QNFT protocol 1 failed to meet the
sensitivity value specified by ANSI Z88.10-2001 for half masks raises
the question of whether it is as protective as the standard
PortaCount[supreg] QNFT protocol, and OSHA has raised this as an issue
for public comment (see below).
The variables for revised PortaCount[supreg] QNFT protocol 2 had
sensitivity values for both half masks and full-facepiece respirators
well in excess of the sensitivity value specified by the ANSI standard.
The sensitivity values for this proposed protocol demonstrate that it
identified 100% of the poorly fitting half masks and full-facepiece
respirators. In addition, this proposed protocol performed well above
the values listed in the ANSI standard for the four remaining
variables, including predictive value of a pass, specificity,
predictive value of a fail, and the kappa statistic. Consistent with
the sensitivity values derived for this proposed protocol, these four
values indicate that the proposed protocol resulted in fit factors that
accurately identified half masks and full-facepiece respirators with
acceptable and poor fits, and that these fit factors agreed closely
with the fit factors attained from the criterion measure.
In discussing the results for revised PortaCount[supreg] QNFT
protocol 2, the authors noted that excluding the two least strenuous
fit-testing exercises (i.e., the initial normal-breathing exercise and
the deep-breathing exercise) from this proposed protocol was a
conservative approach in that the proposed protocol was more likely
than protocols consisting of eight fit-testing exercises to detect
respirator leakage (i.e., using data from less strenuous fit-testing
exercises inappropriately inflates the overall fit factor for
respirators, thereby increasing alpha error). Another conservative
approach used by this proposed protocol was raising the pass-fail
criterion for half masks from a fit factor of 100 to 200, and, for
full-facepiece respirators, from 500 to 1,000. This approach likely
enhanced the sensitivity of the proposed protocol. However, enhancing
sensitivity may increase beta (false-negative) error, which would
increase the number of repeated tests and, consequently, the total
testing time required by some employees to identify a respirator having
an acceptable fit.
C. Conclusions
OSHA believes that the information submitted by Mr. Weed in support
of the proposed protocols meets the criteria for determining whether
OSHA must publish fit-testing protocols for notice-and-comment
rulemaking established by the Agency in Part II of Appendix A of its
Respiratory Protection Standard. Therefore, the Agency concludes that
the proposed protocols warrant notice-and-comment rulemaking under
Section 6(b)(7) of the Act (29 U.S.C. 655), and is initiating this
rulemaking to determine whether to approve these proposed protocols for
inclusion in Part I of Appendix A of its Respiratory Protection
Standard.
The only differences between the two proposed protocols and the
standard PortaCount[supreg] QNFT protocol specified
[[Page 3530]]
currently in Part I.C.3 of Appendix A of the Respiratory Protection
Standard are the duration of the exercises used during fit testing, and
for revised PortaCount[supreg] QNFT protocol 2, the exclusion of the
two least strenuous fit-testing exercises and the raising of the
minimum passing criteria. Therefore, the Agency is proposing to add the
proposed protocols to Part I.C.3 of Appendix A (see section IV of this
preamble titled ``Proposed Amendment to the Standard''). In addition to
decreasing exercise durations from 60 seconds to 30 or 40 seconds, the
proposed revisions to the regulatory text would limit use of revised
PortaCount[supreg] QNFT protocol 2 to respirator users who demonstrate
a minimum passing criteria of 200 for half masks or 1,000 for full-
facepiece respirators. If approved, the proposed protocols would be
alternatives to the existing quantitative fit-testing protocols already
listed in the Part I of Appendix A of the Respiratory Protection
Standard; employers would be free to select these alternatives 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 two proposed protocols, their
effectiveness in detecting respirator leakage, and their usefulness in
selecting respirators that will protect employees from airborne
contaminants in the workplace. Specifically, the Agency invites public
comment on the following issues:
Was the study described in the peer-reviewed journal
article well controlled, and conducted according to accepted
experimental design practices and principles?
Were the results of the study described in this article
properly, fully, and fairly presented and interpreted?
Will the proposed protocols generate reproducible fit-
testing results?
Will the proposed protocols reliably identify respirators
with unacceptable fit as effectively as the quantitative fit-testing
protocols, including the standard PortaCount[supreg] QNFT protocol,
already listed in Part I.C.3 of Appendix A of the Respiratory
Protection Standard?
Is the test-sensitivity value of 0.91 obtained for half
masks by revised PortaCount[supreg] QNFT protocol 1 acceptable in view
of the test-sensitivity value of 0.95 required by ANSI Z88.10-2001. If
not, would it be appropriate for OSHA to limit application of revised
PortaCount[supreg] QNFT protocol 1 to full-facepiece respirators?
The study evaluating the proposed protocols involved only
elastomeric half-mask and full-facepiece respirators. Accordingly, is
it appropriate to apply the results of the study to other types of
respirators (e.g., filtering-facepiece respirators)?
III. Procedural Determinations
A. Legal Authority
The purpose of the Occupational Safety and Health Act of 1970
(``the Act''; 29 U.S.C. 651 et seq.) is ``to assure so far as possible
every working man and woman in the nation safe and healthful working
conditions and to preserve our human resources'' (29 U.S.C. 651(b)). To
achieve this goal, Congress authorized the Secretary of Labor to
promulgate and enforce occupational safety and health standards (29
U.S.C. 655(b) and 654(b)).
Under the Act, 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 Act when it
substantially reduces or eliminates a significant workplace risk, and
is technologically and economically feasible, cost effective,
consistent with prior Agency action or supported by a reasoned
justification for departing from prior Agency action, and supported by
substantial evidence; it also must effectuate the Act's purposes better
than any national consensus standard it supersedes (see International
Union, UAW v. OSHA (LOTO II), 37 F.3d 665 (D.C. Cir. 1994); and 58 FR
16612-16616 (March 30, 1993)). Rules promulgated by the Agency must be
highly protective (see 58 FR 16612, 16614-15 (March 30, 1993); LOTO II,
37 F.3d 665, 669 (D.C. Cir. 1994)). Moreover, Section 8(g)(2) of the
Act authorizes OSHA ``to prescribe such rules and regulations as [it]
may deem necessary to carry out its responsibilities under the Act''
(see 29 U.S.C. 657(g)(2)).
Based on the available evidence, OSHA has preliminarily determined
that the protocols described in the proposed rule meet the legal
requirements to provide substantial protection to employees who use
respirators when exposed to hazardous atmospheres (see Industrial Union
Dept. v. American Petroleum Institute, 448 U.S. 607, 655 (1980);
International Union v. Pendergrass, 878 F.2d 389, 392-93 (DC Cir.
1989); Building and Construction Trades Dept., AFL-CIO v. Brock, 838
F.2d 1258, 1264-65 (DC Cir. 1988)). OSHA also made a preliminary
finding that the proposed rule is technologically feasible because the
protective measures it requires already exist (see American Textile
Mfrs. Institute v. OSHA (Cotton Dust), 452 U.S. 490, 513 (1981);
American Iron and Steel Institute v. OSHA (Lead II), 939 F.2d 975, 980
(DC Cir. 1991)). Specifically, 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. In this regard, for OSHA to adopt the proposed protocols
in the final rule, OSHA would have to determine that the proposed
protocols provide employees with protection that is comparable to the
protection afforded to them by the provisions of the standard
PortaCount[supreg] QNFT protocol. If adopted, the protocols would not
replace existing fit-testing protocols, but instead would be
alternatives to them. Therefore, OSHA preliminarily finds that the
proposal would not directly increase or decrease the protection
afforded to employees, nor would it increase employers' compliance
burdens. As demonstrated in the following section, the proposal may
reduce employers' compliance burdens by decreasing the time required to
fit test respirators for employee use. Accordingly, OSHA concludes that
it is unnecessary to determine significant risk or the extent to which
this proposal would reduce that risk, as typically would be required by
Industrial Union Department, AFL-CIO v. American Petroleum Institute,
448 U.S. 607 (1980).
The Agency believes that the proposed rule is economically feasible
because the employers can absorb or pass on the costs of compliance
without threatening their long-term profitability or competitive
structure (see Cotton Dust, 452 U.S. at 530 n. 55 (1981); Lead II, 939
F.2d 975, 980 (DC Cir. 1991)). Moreover, the preliminary economic
analysis of the proposed rule describes the benefits and costs of the
proposed rule (see section III.B. of this preamble, ``Preliminary
Economic Analysis and Initial Regulatory Flexibility Analysis''). Based
on this information, OSHA made a preliminary determination that the
proposed rule is an economically feasible means of meeting its
statutory objective of reducing the risk associated with employee
exposure to hazardous atmospheres while using respirators (see
[[Page 3531]]
Cotton Dust, 453 U.S. at 514 n. 32 (1981); LOTO II, 37 F.3d 665, 668
(DC Cir. 1994)).
B. Preliminary Economic Analysis and Initial Regulatory Flexibility
Analysis
The proposal is not economically significant within the context of
Executive Order (``E.O.'') 12866 (58 FR 51735), or 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 a significant or major rule specified by
E.O. 12866 or other relevant statutes.
The proposal offers employers additional options to fit test their
employees for respirator use. In this regard, OSHA would supplement the
standard PortaCount[supreg] QNFT protocol currently in Appendix A of
the Respiratory Protection Standard with the proposed protocols if it
approves them as a result of this proposed rulemaking. According to a
recent survey of respirator use conducted by the National Institute for
Occupational Safety and Health and the Bureau of Labor Statistics,
approximately 7,500 establishments currently use an ambient-aerosol
protocol out of nearly 282,000 establishments found by the survey to
require respirator use (Ex. 6-3, Docket No. H049C (``Respiratory
Protection--Assigned Protection Factors'').\4\
---------------------------------------------------------------------------
\4\ The standard PortaCount[supreg] QNFT protocol is the only
ambient-aerosol protocol currently listed in Appendix A of the
Respiratory Protection Standard.
---------------------------------------------------------------------------
Under this proposal, employers would have a choice between the
standard PortaCount[supreg] QNFT protocol consisting of exercises
lasting one minute each, or the proposed protocols with exercises (six
or eight) lasting 30 or 40 seconds each. 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 protocols would be adopted by some employers who currently use
the standard PortaCount[supreg] QNFT protocol for their employees.
These employers would adopt the proposed protocols because these
protocols would take less time to administer than the standard
PortaCount[supreg] QNFT protocol, thereby decreasing the cost required
for fit testing their employees. However, the Agency believes that the
proposed protocols are unlikely to be adopted by employers who
currently perform fit testing using other quantitative or qualitative
fit tests 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
quantitative 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 protocols instead. Therefore, using one of the proposed fit-
testing protocols 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).
This E.O. 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. The E.O. allows Federal agencies to preempt State
law only with the expressed consent of Congress. In such cases, Federal
agencies must limit preemption of State law to the extent possible.
Section 18 of the Act; 29 U.S.C. 651 et seq.), expressly provides
OSHA with authority to preempt State occupational safety and health
standards to the extent that the Agency promulgates a Federal standard
under Section 6 of the Act. Accordingly, Section 18 of the Act
authorizes the Agency to preempt State promulgation and enforcement of
requirements dealing with occupational safety and health issues covered
by OSHA standards unless the State has an OSHA-approved occupational
safety and health plan (namely, is a ``State-plan State''). (See Gade
v. National Solid Waste Management Association, 112 S. Ct. 2374
(1992).)
With respect to States that do not have OSHA-approved plans, the
Agency concludes that this proposed rule conforms to the preemption
provisions of the Act. Additionally, Section 18 of the 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. Therefore, for States that do not have approved
occupational safety and health plans, this proposed rule would not
affect the preemption provisions of Section 18 of the Act.
OSHA has authority under E.O. 13132 to propose the use of
additional fit-testing protocols under its Respiratory Protection
Standard at 29 CFR 1910.134 because the problems addressed by these
fit-testing requirements are national in scope. The Agency
preliminarily concludes that the fit-testing protocols proposed by this
rulemaking would provide employers in every State with procedures that
would assist them in protecting their employees from the risks of
exposure to atmospheric hazards. In this regard, the proposal offers
thousands of employers across the nation an opportunity to use
additional protocols to assess respirator fit among their employees.
Therefore,
[[Page 3532]]
the proposal would provide employers in every State with an alternative
means of complying with the fit-testing requirements specified by
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 Act (29 U.S.C. 667(c)(2)) requires State-plan
States to adopt the same standard, or to develop and enforce an
alternative standard that is at least as effective as the OSHA
standard. However, the new fit-testing protocols 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 proposed rulemaking. Nevertheless, OSHA strongly
encourages them to adopt the final provisions to provide additional
compliance options to employers in their States.
In summary, this proposed rule complies with E.O. 13132. In States
without OSHA-approved State Plans, Congress expressly provides for OSHA
standards to preempt State job safety and health rules in areas
addressed by the Federal standards; in these States, this proposed rule
would limit State policy options in the same manner as every standard
promulgated by the Agency. In States with OSHA-approved State Plans,
this rulemaking does not significantly limit State policy options.
E. State-Plan States
Section 18(c)(2) of the Act (29 U.S.C. 667(c)(2)) requires State-
Plan States to adopt mandatory standards promulgated by OSHA. However,
as noted in the previous section of this preamble, States with OSHA-
approved State Plans would not be obligated to adopt the final
provisions that may result from this proposed rulemaking. Nevertheless,
OSHA strongly encourages them to adopt the final provisions to provide
compliance options to employers in their States. In this regard, OSHA
preliminarily concludes that the fit-testing protocols proposed by this
rulemaking would provide employers in the State-Plan States with
procedures that would protect the safety and health of employees who
use respirators against hazardous airborne substances in their
workplace at least as well as the standard PortaCount[supreg] QNFT
protocol. The 24 States and two Territories with State Plans 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 (58 FR 58093). As discussed above in section III.B of this
preamble (``Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis''), 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-
sector employers; therefore, this proposal is not a significant
regulatory action within the meaning of Section 202 of the UMRA (2
U.S.C. 1532).
Under voluntary agreement with OSHA, some States enforce compliance
with their State standards on public-sector entities, and these
agreements specify that these State standards must be equivalent to
OSHA standards. Thus, although OSHA preliminarily concludes that the
proposed protocols would impose no additional costs on public-sector
employers, the proposal would not involve any unfunded mandates imposed
on any other State or local government entity. 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 preliminarily
certifies that this proposal does not mandate that State, local, or
tribal governments adopt new, unfunded regulatory obligations, nor does
the proposed rule increase expenditures by the private sector of more
than $100 million a year.
G. Applicability of Existing Consensus Standards
Section 6(b)(8) of the Act (29 U.S.C. 655(b(8)) requires OSHA to
explain ``why a rule promulgated by the Secretary differs substantially
from an existing national consensus standard,'' by publishing ``a
statement of the reasons why the rule as adopted will better effectuate
the purposes of the Act than the national consensus standard.'' In this
regard, 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. Later, the American National Standards Institute (ANSI)
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 7.2 of ANSI Z88.10-2001 specifies the requirements for
conducting a PortaCount[supreg] quantitative fit test, which differ
substantially from the standard PortaCount[supreg] QNFT protocol
provided in Part I.C.3 of OSHA's Respiratory Protection Standard. These
protocols differ in terms of the fit-testing exercises required, and
the duration of these exercises. In addition, the ANSI standard
provides no data or information on the accuracy and reliability of its
protocol. The Agency believes that limiting fit-testing options to the
protocol currently specified by the ANSI standard would seriously
impede the development of fit-testing protocols that are more accurate
and reliable, and less costly to administer, than the ANSI protocol.
H. Advisory Committee for Construction Safety and Health Review of the
Proposed Standard
The proposal to add two quantitative fit-testing protocols to Part
I.C of Appendix A of OSHA's Respiratory Protection Standard would
affect the construction industry because it revises the fit-testing
requirements specified by the standard, which is applicable to the
construction industry.\5\ Whenever the Agency proposes a rule involving
construction activities, the Contract Work Hours and Safety Standards
Act (Construction Safety Act) (40 U.S.C. 3704), OSHA regulations
governing the Advisory Committee for Construction Safety and Health
(ACCSH) (i.e., 29 CFR 1912.3), and provisions governing OSHA rulemaking
(i.e., 29 CFR 1911.10) require OSHA to consult with the ACCSH.
Specifically, 29 CFR 1911.10 requires that the Assistant Secretary
provide the ACCSH with ``any proposal
[[Page 3533]]
of his own,'' together with ``all pertinent factual information
available to him, including the results of research, demonstrations,
and experiments.'' Accordingly, OSHA provided the ACCSH members with
copies of the proposal and other relevant information several weeks
before the January 24, 2008, ACCSH meeting. OSHA staff met with the
ACCSH at that meeting to discuss the proposal, and to answer members'
questions about it. At the end of this session, the ACCSH voted to
defer making any recommendations to OSHA regarding the proposal until
their next meeting so they could thoroughly review the proposal and the
other relevant information, including the peer-reviewed article
described above under section II.B of this notice (``Summary of the
Peer-Reviewed Article'').
---------------------------------------------------------------------------
\5\ The Respiratory Protection Standard for the construction
industry at 29 CFR 1926.103 cross-references the Respiratory
Protection Standard for general industry at 29 CFR 1910.134.
---------------------------------------------------------------------------
At the May 16, 2008, ACCSH meeting, OSHA staff again met with the
ACCSH to discuss the proposal. Following this discussion, the ACCSH
recommended unanimously that OSHA: (1) Remove the PortaCount[supreg]
QNFT protocol 1 from the proposal because it failed to meet the ANSI
Z88.10-2001 criteria for test sensitivity and predicted value of a
pass; and (2) include the PortaCount[supreg] QNFT protocol 2 in the
proposal because it met all of the ANSI Z88.10-2001 criteria.
I. Public Participation
OSHA encourages members of the public to participate in this
rulemaking by submitting comments on the proposal, as well as
documentary evidence in support of these comments. Accordingly, the
Agency invites interested parties having knowledge of, or experience
with, respirator fit-testing protocols to participate in this process,
and welcomes any pertinent information that will provide it with the
best available evidence on which to develop the final regulatory
provisions. The Agency invites interested parties to submit written
views, arguments, and data concerning this proposed rule, including:
responses to the issues specified under section II.B of this preamble
(``Issues for Public Comment''), and comments on OSHA's determination
of the economic or other regulatory impacts of the proposed rule on the
regulated community. Comments may be submitted in response to this
Federal Register notice: (1) Electronically at https://
www.regulations.gov, which is the Federal eRulemaking portal; (2) by
facsimile (fax); or (3) by hard copy. When submitting comments, follow
the procedures specified above in the sections of this preamble titled
DATES and ADDRESSES. All comments, attachments, and other material must
identify the Agency name and the OSHA docket number for this rulemaking
(Docket No. OSHA-2007-0007). In addition, comments must clearly
identify the provision of the proposal being addressed, the position
taken with respect to an issue, and the basis for that position.
Comments, along with supporting data and references, received by the
end of the specified comment period will become part of the proceedings
record. This material, including comments, is available for public
inspection without change at https://www.regulations.gov \6\ and at
OSHA's docket Web site at https://www.dockets.osha.gov (under Docket No.
OSHA-2007-0007). Therefore, OSHA cautions commenters about submitting
personal information such as social security numbers and birth dates
with their comments. Exhibits referenced in this Federal Register
notice also will be available at https://www.regulations.gov and https://
www.dockets.osha.gov under the same docket number.
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\6\ Information on using this Web site to submit comments and to
access dockets is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information and assistance about
using the Internet to locate docket submissions.
---------------------------------------------------------------------------
Material that supplements electronic comments may be uploaded
electronically (including by fax). Supplemental material also may be
mailed to the OSHA Docket Office (see the section of this preamble
titled ADDRESSES) provided it identifies the electronic comments using
the commenter's name, comment submission date, and docket number so
OSHA can attach the materials to the appropriate comments. Reading or
downloading some of this material (e.g., copyrighted material) from the
https://www.regulations.gov and https://www.dockets.osha.gov Web sites is
not possible; however, this material is available for inspection and
copying (along with comments and exhibits) at the OSHA Docket Office
(see the section of this preamble titled ADDRESSES).
Security-related procedures may delay significantly the delivery of
comments and other material submitted through the regular mail. For
information about security procedures involving the regular mail, as
well as express delivery and messenger or courier service, contact the
OSHA Docket Office at (202) 693-2350 (TTY (877) 889-5627).
Electronic copies of this Federal Register notice are available at
https://www.regulations.gov. This notice, as well as news releases and
other relevant information, also are available at OSHA's Web site at
https://www.osha.gov.
List of Subjects in 29 CFR Part 1910
Fit testing, Hazardous substances, Health, Occupational safety and
health, Respirators, Toxic substances.
Authority and Signature
Thomas M. Stohler, Acting 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 January 13, 2009.
Thomas M. Stohler,
Acting 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), 5-2002 (67 FR 65008), 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. Add paragraphs (c) and (d) to section C.3 of Appendix A to Sec.
1910.134 to read as follows:
Sec. 1910.134 Respiratory protection.
* * * * *
[[Page 3534]]
Appendix A to Sec. 1910.134: Fit Testing Procedures (Mandatory)
* * * * *
C. * * *
* * * * *
3. * * *
* * * * *
(c) Revised PortaCount[supreg] Quantitative Fit-Testing Protocol
1.
(1) When administrating this protocol to test subjects (i.e.,
employees), employers must comply with the requirements specified in
paragraphs (a) and (b) of Part 1.C.3 of this appendix. In addition,
employers must use the eight fit-testing exercises specified in
section I.A.14 of this appendix when administering this protocol.
Test subjects must perform these fit-testing exercises for at least
30 seconds, except for the grimace exercise, which test subjects
must perform for 15 seconds.
(2) Calculate the overall fit factor for this protocol as
follows:
[GRAPHIC] [TIFF OMITTED] TP21JA09.126
Note to Paragraph (c)(2): Only seven of the eight fit-testing
exercises are used in this calculation because the results for the
grimace exercise (ff6) are not included in the
calculation.
(d) Revised PortaCount[supreg] Quantitative Fit-Testing Protocol
2.
(1) When administrating this protocol to test subjects (i.e.,
employees), employers must comply with the requirements specified in
paragraphs (a) and (b) of Part 1.C.3 of this appendix. In addition,
employers must use the fit-testing exercises specified in section
I.A.14 of this appendix when administering this protocol, except
that test subjects must not perform the fit-testing exercises
specified by paragraphs (a)(1) and (a)(2) of section I.A.14 (i.e.,
the initial normal-breathing exercise and the deep-breathing
exercise, respectively). Test subjects must perform these fit-
testing exercises for at least 40 seconds, except for the grimace
exercise, which test subjects must perform for 15 seconds.
(2) This protocol requires the following minimum pass-fail fit-
testing criteria: for half masks, an overall fit factor of 200
(instead of the usual 100); and, for full-facepiece respirators, an
overall fit factor of 1,000 (instead of the usual 500).
(3) Calculate the overall fit factor for this protocol as
follows:
[GRAPHIC] [TIFF OMITTED] TP21JA09.122
Note to Paragraph (d)(3): Only five of the eight fit-testing
exercises are used in this calculation because test subjects do not
perform the initial normal-breathing exercise (ff1) and
the deep-breathing exercise (ff2), and the results for
the grimace exercise (ff6) are not included in the
calculation.
* * * * *
[FR Doc. E9-922 Filed 1-16-09; 8:45 am]
BILLING CODE 4510-26-P
