[Federal Register: January 21, 2009 (Volume 74, Number 12)][Proposed Rules] [Page 3526-3534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja09-36]
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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.
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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.
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\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
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: http://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 http://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 http://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 http://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 http://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® quantitative fit-testing protocol
(hereafter, "the standard PortaCount® QNFT protocol"). OSHA
included the standard PortaCount® QNFT protocol in Appendix A of
its final Respiratory Protection Standard.
(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").
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\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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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.
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\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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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® 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.
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In-mask
Duration of sampling
Protocol Number of each exercise duration for
exercises (secs.) each exercise
(secs.) \1\
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Standard PortaCount® QNFT Protocol........ 8 60 40
Revised PortaCount® QNFT Protocol 1....... 8 30 10
Revised PortaCount® QNFT Protocol 2....... \2\ 6 40 20
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\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® 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® 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® 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.
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Values for half-mask respirators
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Variables Revised Revised
ANSI requirement PortaCount® PortaCount®
QNFT Protocol 1 QNFT Protocol 2
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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
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\1\ = Fail.
\2\ = Borderline fail.
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Values for full-facepiece respirators
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Variables Revised Revised
ANSI requirement PortaCount® PortaCount®
QNFT Protocol 1 QNFT Protocol 2
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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
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\1\ = 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 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® 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 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 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® QNFT protocol specified
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 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® 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® 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 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® 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
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\
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\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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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 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, 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® 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® 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 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").
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\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®
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 http://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 http://www.regulations.gov \6\ and at
OSHA's docket Web site at http://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 http://www.regulations.gov and http://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
http://www.regulations.gov and 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
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also are available at OSHA's Web site at
http://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.
* * * * *
Appendix A to Sec. 1910.134: Fit Testing Procedures (Mandatory)
* * * * *
C. * * *
* * * * *
3. * * *
* * * * *
(c) Revised PortaCount® 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:
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 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:
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
