[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Rules and Regulations]
[Pages 46986-46994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17765]


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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. H-049D]
RIN 1218-AC05


Controlled Negative Pressure REDON Fit Testing Protocol

AGENCY: Occupational Safety and Health Administration (OSHA), 
Department of Labor.

ACTION: Final rule.

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SUMMARY: In this rulemaking, OSHA is approving an additional 
quantitative fit testing protocol, the controlled negative pressure 
(CNP) REDON fit testing protocol, for inclusion in Appendix A of its 
Respiratory Protection Standard. The protocol affects, in addition to 
general industry, OSHA respiratory protection standards for shipyard 
employment and construction. The Agency is adopting this protocol under 
the provisions contained in the Respiratory Protection Standard that 
allow individuals to submit evidence for including additional fit 
testing protocols in this standard.
    The CNP REDON protocol requires the performance of three different 
test exercises followed by two redonnings of the respirator, while the 
CNP protocol approved previously by OSHA specifies eight test 
exercises, including one redonning of the respirator. In addition to 
amending the Standard to include the CNP REDON protocol, this 
rulemaking makes several editorial and non-substantive technical 
revisions to the Standard associated with the CNP REDON protocol and 
the previously approved CNP protocol.

DATES: The final rule becomes effective September 3, 2004.

ADDRESSES: In compliance with 28 U.S.C. 2212(a), the Agency designates 
the Associate Solicitor for Occupational Safety and Health, Office of 
the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution 
Ave., NW, Washington, DC 20210, as the recipient of petitions for 
review of this rulemaking.

FOR FURTHER INFORMATION CONTACT: For technical inquiries, contact Mr. 
John E. Steelnack, Directorate of Standards and Guidance, Room N-3718, 
OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW, 
Washington, DC 20210; telephone (202) 693-2289 or by facsimile (202) 
693-1678. Copies of this Federal Register notice are available from the 
OSHA Office of Publications, Room N-3101, U.S. Department of Labor, 200 
Constitution Avenue, NW, Washington DC 20210; telephone (202) 693-1888. 
For an electronic copy of this notice, go to OSHA's Web site (http://www.osha.gov), and select ``Federal Register,'' ``Date of 
Publication,'' and then ``2004.''

SUPPLEMENTARY INFORMATION:

I. Background

    The Respiratory Protection Standard includes the following three 
quantitative fit testing protocols: Generated-aerosol; ambient-aerosol 
condensation nuclei counter; and controlled negative pressure (CNP). 
Part II of Appendix A of the Respiratory Protection Standard specifies, 
in part, the procedure individuals must follow to submit new fit 
testing protocols for the Agency's consideration. The criteria OSHA 
uses for determining whether to propose adding a fit testing protocol 
to the Respiratory Protection Standard 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 test data 
support the accuracy and reliability of the protocol. When a protocol 
meets one of these criteria, the Agency conducts a notice-and-comment 
rulemaking under Section 6(b)(7) of the Occupational Safety and Health 
Act of 1970 (29 U.S.C. 655). As OSHA noted in the proposal, the CNP 
REDON protocol met the second of these criteria (68 FR 33887; June 6, 
2003).

II. Summary and Explanation of the Final Standard

A. Introduction

    With his letter submitting the CNP REDON protocol for review, Dr. 
Clifton D. Crutchfield included copies of two peer-reviewed articles 
from industrial-hygiene journals describing the accuracy and 
reliability of the proposed protocol (Exs. 2 and 3). In this 
submission, Dr. Crutchfield also described in detail the equipment and 
procedures required to administer the proposed protocol. According to 
this description, the proposed protocol is a variation of the CNP 
protocol developed by Dr. Crutchfield in the early 1990s, and which 
OSHA approved for inclusion in paragraphs (a) and (d) of Part I.C.4 of 
Appendix A when the Agency revised its Respiratory Protection Standard 
(63 FR 1152; January 8, 1998). Although the proposed protocol has the 
same fit-test requirements and uses the same test equipment as the CNP 
protocol previously approved by OSHA, it includes only three test 
exercises followed by two redonnings of the respirator instead of the 
eight test exercises and one respirator redonning required by the 
previously approved CNP protocol. The three test exercises, listed in 
order of administration, are normal breathing, bending over, and head 
shaking. The procedures for administering these three test exercises 
and the two respirator donnings to an employee, and for measuring 
respirator leakage during each test, are described below:
     Facing forward. In a normal standing position, without 
talking, the test subject must breathe normally for 30 seconds; then, 
while facing forward, he or she must hold his or her breath for 10 
seconds for test measurement.
     Bending over. The test subject (i.e., employee) must bend 
at the waist for 30 seconds as if he or she is going to touch his or 
her toes; then, while facing parallel to the floor, he or she must hold 
his or her breath for 10 seconds for test measurement.
     Head shaking. The test subject must shake his or her head 
back and forth vigorously several times while shouting for 
approximately three seconds; then, while facing forward, he or she must 
hold his or her breath for 10 seconds for test measurement.
     First redonning (REDON-1). The test subject must remove 
the respirator, loosen all facepiece straps, and then redon the 
respirator mask; after redonning the mask, he or she must face forward 
and hold his or her breath for 10 seconds for test measurement.
     Second redonning (REDON-2). The test subject must remove 
the respirator, loosen all facepiece straps, and then redon the 
respirator mask again; after redonning the mask, he or she must face 
forward and hold his or her breath for 10 seconds for test measurement. 
As noted earlier, Dr. Crutchfield submitted two peer-reviewed journal 
articles that

[[Page 46987]]

provided information on the accuracy and reliability of the proposed 
CNP REDON protocol. In the first of these articles, the most important 
conclusion made by the authors was that the protocol results in 
substantially lower respirator fit factors overall than the most 
commonly used ambient-aerosol protocol. Lower fit factors indicate that 
the CNP REDON protocol detects more respirator leaks than the ambient-
aerosol protocol, thereby providing employees with an increased margin 
of safety when they select respirators. The main conclusion reached by 
the authors in the second article was that the overall fit factors 
obtained from the three exercises and two redonnings required by the 
CNP REDON protocol are the same as the overall fit factors found when 
using the previously approved CNP protocol described in the Respiratory 
Protection Standard. Therefore, compared to the previously approved CNP 
protocol, the CNP REDON protocol submitted by Dr. Crutchfield obtains 
at least the same overall fit factors with fewer exercises and in less 
time.
    OSHA found that the information submitted by Dr. Crutchfield in 
support of the CNP REDON protocol met the criteria for proposing to add 
new fit testing protocols to Part I of Appendix A of the Respiratory 
Protection Standard. Therefore, the Agency initiated a rulemaking 
proposing to approve the CNP REDON protocol for inclusion in Appendix A 
of the Respiratory Protection Standard. However, because the only 
difference between the proposed CNP REDON protocol and the previously 
approved CNP protocol is the exercise procedure used during fit 
testing, the Agency proposed to limit the regulatory text revisions to 
a description of the proposed CNP REDON exercise procedure, and to 
refer instead to the previously approved CNP protocol described in 
paragraphs (a) and (c) of Part I.C.4 for information on CNP fit testing 
requirements and the CNP test instrument.

B. Editorial and Technical Revisions to the Respiratory Protection 
Standard

    In the proposal, OSHA also included several editorial and technical 
revisions to the language describing the two CNP fit testing protocols. 
The first proposed editorial revision added the CNP REDON protocol to 
the exception already specified for the previously approved CNP 
protocol under paragraph 14(a) of Part I.A in Appendix A of the 
Respiratory Protection Standard. Accordingly, paragraph 14(a) would 
exempt both the previously approved CNP protocol, as well as the 
proposed CNP REDON protocol, from the test exercises specified for the 
other approved fit testing protocols listed in the appendix. OSHA 
believed that this revision is necessary because the CNP REDON protocol 
consists of a test exercise procedure that differs substantially from 
the procedure required for the other OSHA-approved fit testing 
protocols.
    The second editorial revision included in the proposal involved the 
introductory paragraph describing the previously approved CNP protocol 
in Part I.C.4 of Appendix A of the Respiratory Protection Standard. The 
eighth sentence in this paragraph refers to the CNP instrument 
manufacturer as ``Dynatech Nevada.'' However, the instrument 
manufacturer now is Occupational Health Dynamics of Birmingham, 
Alabama. OSHA proposed to revise this sentence to identify the current 
manufacturer of this instrument.
    As noted in the proposal, Dr. Crutchfield stated that test 
administrators use either an auditory warning device or the screen 
tracing currently provided on the CNP test instrument to detect 
participants' failure to hold their breath for the required 10-second 
period when measuring respirator fit (Ex. 14). While using the screen 
tracing for this purpose was not part of the previously approved CNP 
protocol, the Agency believed that such a visual warning device would 
be a useful adjunct in measuring respirator fit under both the 
previously approved CNP protocol and the proposed CNP REDON protocol. 
Therefore, the Agency proposed to revise paragraph (c) of the 
previously approved CNP protocol (under Part I.A.4 of the Respiratory 
Protection Standard) to include the screen tracing currently provided 
on the CNP test instrument as a visual warning device to detect test 
subjects' non-compliance with the breath-hold procedure.
    In a 1998 journal article entitled ``CNP Fit Testing Under OSHA's 
Updated Respiratory Protection Standard,'' published in Respiratory 
Protection Update, Dr. Crutchfield indicated that the Agency's 
description of the CNP fit-test requirements in paragraph (a)(5) of the 
previously approved CNP protocol contained an error (Ex. 8). 
Specifically, he noted the breath-hold requirement in paragraph (a)(5) 
should be 10 (not 20) seconds. OSHA agreed. Accordingly, the Agency 
proposed to revise this requirement because implementing correct fit-
test procedures would improve the assessment of respirator fit factors 
using the previously approved CNP protocol, as well as the proposed CNP 
REDON protocol.

C. Comments to the Proposal

    In the proposal, OSHA requested the public to submit comments and 
data regarding the accuracy and reliability of the CNP REDON protocol, 
as well as its effectiveness in detecting respirator leakage and its 
usefulness in selecting respirators that protect employees from 
airborne contaminants in the workplace (68 FR 33887; June 6, 2003). 
Specifically, the Agency invited public comment on the following 
issues:
     Were the studies described in the peer-reviewed articles 
well controlled, and conducted according to accepted experimental 
design practices and principles?
     Were the results of the studies described in the peer-
reviewed articles properly, fully, and fairly presented and 
interpreted?
     Will the proposed protocol reliably identify respirators 
with unacceptable fit as effectively as the quantitative fit testing 
protocols already listed in Part I.C of Appendix A of the Respiratory 
Protection Standard?
     Will the proposed protocol generate reproducible fit 
testing results?
     Should OSHA expand application of the proposed protocol 
fit-test exercises to other quantitative fit tests (e.g., ambient 
aerosol tests)?
     Will the proposed editorial and technical revisions to 
Part I of Appendix A improve proper implementation of the approved CNP 
protocol and the proposed CNP REDON protocol?
    The Agency received 66 written comments and 116 electronic comments 
in response to its request for comments in the proposal (Exs. 3-1 to 3-
66 and 4-1 to 4-116, respectively). The following paragraphs in this 
section address the comments made on each of the six issues described 
previously.
1. Were the Studies Described in the Peer-Reviewed Articles Well 
Controlled, and Conducted According to Accepted Experimental Design 
Practices and Principles?
    Dr. Kent Oestenstad of the University of Alabama at Birmingham 
emphasized the high quality of the research studies supporting the CNP 
REDON protocol. In doing so, he stated that the research studies ``were 
well controlled and conducted according to established and accepted 
experimental design'' (Ex. 4-88), a judgment confirmed by their 
acceptance for publication in peer-reviewed journals.
    Several commenters questioned the research underlying the proposed 
protocol. One commenter stated that it

[[Page 46988]]

was inappropriate to validate the protocol based on ambient-aerosol 
concentrations measured using PortaCount equipment (Ex. 4-102). Another 
commenter asserted that the underlying research studies did not 
adequately support the accuracy and reliability of the proposed 
protocol, and cited problems with each of the articles (Ex. 3-32). In 
his view, the first article was deficient because only three test 
exercises (and no redonning exercises) from the proposed protocol were 
used, poor-fitting masks were not included, the numbers of test 
subjects were statistically inadequate, data from half-mask and full-
facepiece respirators were mixed inappropriately, a mixture of fit 
factors for the minimum pass-fail criterion was used, data from two 
different ambient-aerosol protocols were combined, paired t-tests were 
not used when comparing each test subject's performance on the two 
protocols, and statistical sensitivity was poor (see, also, Exs. 3-60 
and 4-84). The same commenter found the second article inadequate in 
that poor-fitting masks were not included and the criteria for 
evaluating new fit-test protocols specified in ANSI Z88.10-2001 were 
not met. Two commenters claimed that the proposed protocol cannot be 
evaluated using pass-fail fit factors derived using an aerosol 
challenge agent because a low correlation exists between fit factors 
assessed using the previously approved CNP protocol and an aerosol-
based protocol (Exs. 4-92 and 4-102).
    Regarding these comments, a review of the first study shows that 
redonning was performed between each of the fit tests, while the second 
study used the full CNP REDON protocol, including two redonning 
exercises. In addition, the pass-fail distributions for the studies 
indicate that respirator fit varied substantially among the test 
subjects. While the Agency agrees that inaccurate and unreliable 
measurements and combining results for different respirator types may 
lead to inconsistent results with large statistical variations, the 
peer-reviewed studies showed that the results were consistent and that 
large statistical variations did not occur. For example, these studies 
showed clearly that fit factors from the CNP REDON protocol were 
consistently lower than fit factors from the ambient-aerosol protocol 
and the CNP protocol previously approved by OSHA. Additionally, to be 
accepted for publication in peer-reviewed journals, the studies had to 
conform with the experimental-design and statistical procedures and 
practices used by the industrial-hygiene research community to collect 
and analyze data.
    As for the observation that the studies used an insufficient number 
of test subjects, the industrial-hygiene research community does not 
use a specified number of test subjects to assess fit testing 
protocols. Moreover, specifying a minimum number of test subjects for 
fit testing research would be arbitrary. Finally, had the sample sizes 
been too small to produce reliable results, the studies would not have 
been accepted for publication in peer-reviewed journals.
    The commenters who addressed fit factors based on aerosol challenge 
agents provided no data or additional information to support their 
position and, thus, were not able to negate the results of the first 
study submitted by Dr. Crutchfield, which showed a close correspondence 
between the results of the CNP REDON and ambient-aerosol protocols.
    In summary, the Agency finds that these comments did not identify 
any shortcoming in the research underlying the proposed protocol that 
would offset the criteria used to evaluate that research under the 
peer-review process. Furthermore, OSHA considers the results described 
in these articles to be reliable and valid. Therefore, the Agency has 
concluded that these results provide robust scientific support for the 
CNP REDON protocol as described in the proposal.
2. Were the Results of the Studies Described in the Peer-Reviewed 
Articles Properly, Fully, and Fairly Presented and Interpreted?
    Dr. Oestenstad observed that ``[s]tatements in the conclusions and 
results were fairly reported and interpreted'' (Ex. 4-88). However, 
another commenter observed that ``virtually all studies showing 
favorable performance by the CNP method were authored or co-authored by 
the inventor/developer of that method,'' an observation made by other 
commenters as well (Exs. 3-32, 3-58, 4-84, and 4-91).
    The Agency finds Dr. Oestenstad's comments convincing because, as 
noted in his responses to the third issue (see below), his laboratory 
has performed independent research on the CNP protocol previously 
approved by OSHA. Therefore, Dr Oestenstad is in an ideal position to 
know whether the results of the peer-reviewed articles were properly, 
fully, and fairly presented and interpreted, and whether the CNP 
protocol provides equivalent protection to workers. Additionally, the 
peer-review process specifically removes effects that may have been due 
to bias on the part of the authors.\1\ The Agency finds that the 
observations made by the other commenters simply oppose the supporting 
studies without presenting information or data that contradict the 
results.
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    \1\ To ensure minimal bias on the part of both authors and peer 
reviewers, the journal Applied Occupational and Environmental 
Hygiene (the journal in which Dr. Crutchfield published the first 
article submitted in support of the CNP REDON protocol) requires a 
double-blind review (i.e., both the authors and the reviewers remain 
anonymous to each other).
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3. Will the Proposed Protocol Reliably Identify Respirators With 
Unacceptable Fit as Effectively as the Quantitative Fit Testing 
Protocols Already Listed in Part I.C of Appendix A of the Respiratory 
Protection Standard?
    In his comments, Dr. Crutchfield described the two peer-reviewed 
studies that he submitted to OSHA in support of the proposed CNP REDON 
protocol, and stated that these studies showed that fit factors 
obtained using this protocol were significantly lower than fit factors 
obtained using the ambient-aerosol fit test previously approved by OSHA 
(Ex 4-13). He noted that the first study assessed the impact of fit-
test exercises and donning on respirator fit; consequently, he 
questioned the current practice of basing determinations of respirator 
fit on a single donning of a respirator mask.\2\ The second study 
involved fit testing Tucson firefighters using both the previously 
approved CNP protocol and the proposed CNP REDON protocol. Dr. 
Crutchfield observed that this study demonstrated that fit factors 
obtained using the proposed protocol were lower than fit factors 
achieved with the previously approved CNP protocol, although this 
difference was not significant statistically.
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    \2\ In the first study, multiple donnings consisted of removing 
and redonning the respirator between each fit test.
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    Dr. Crutchfield also submitted, with his comments, a paper that he 
drafted (Ex. 4-13-1). This paper described two studies in which a 
hypodermic needle was used to allow air to leak into the facepiece of a 
respirator in a predictable manner (i.e., to simulate poor respirator 
fit). The first study measured this leakage in half-mask respirators 
worn by five test subjects who each performed six fit-test exercises 
while being assessed using either the FitTester 3000 or the PortaCount 
Plus.\3\ The second

[[Page 46989]]

study evaluated this leakage at three locations in a half-mask or full-
facepiece respirator mounted on a head form; this study also used the 
FitTester 3000 and the PortaCount Plus to assess the leakage. The 
results of these two studies showed that the CNP fit testing system 
produced substantially less variability, and detected more respirator 
leakage, than the ambient-aerosol fit testing system.
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    \3\ The exercises used for the CNP protocol were facing forward, 
moving the head left, moving the head right, moving the head up, 
moving the head down, and facing forward, while the six exercises 
used for the ambient-aerosol protocol were normal breathing, deep 
breathing, moving the head side to side, moving the head up and 
down, reciting the Rainbow Passage, and normal breathing.
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    This paper also described a meta-analysis of six published studies, 
each of which compared fit factors obtained for the CNP and ambient-
aerosol fit-test systems. Consistent with the results of the previous 
two studies, the meta-analysis found that the CNP fit tests produced 
consistently and substantially lower fit factors than the ambient-
aerosol fit tests.
    OSHA believes the three studies described in Dr. Crutchfield's 
unpublished paper deserve serious consideration. The first two studies 
warrant consideration because the hypodermic-needle methodology has 
been demonstrated to be a reliable and valid measure of respirator 
leakage in at least two peer-reviewed journals,\4\ and the methodology 
also is described in Annex A2 of the ANSI Z88.10-2001 consensus 
standard as a research methodology for use in validating fit testing 
protocols. The third study did not involve collecting independent data, 
but used meta-analysis for the purpose of determining the overall 
strength of the protocol differences obtained in studies already 
published in peer-reviewed journals. The Agency also notes that while 
it is possible that differences between the exercises used in the CNP 
and ambient-aerosol protocols in the first study may account for some 
of the differences observed between the protocols, it is clear that the 
direction of these differences (i.e., the CNP protocol being more 
conservative than the ambient-aerosol protocol) is consistent with the 
findings of the second and third studies, as well as the peer-reviewed 
articles submitted by Dr. Crutchfield in support of the proposed CNP 
REDON protocol.
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    \4\ Crutchfield, C. D., Park, D. L., Henshel, J. L., et al. 
(1995). Determinations of known respirator leakage using controlled 
negative pressure and ambient aerosol QNFT systems. American 
Industrial Hygiene Association Journal, vol. 56, pp. 16-23; and 
Crutchfield, C. D. and Park, D. L. (1997). Effect of leak location 
on measured respirator fit. American Industrial Hygiene Association 
Journal, vol. 58, pp. 413-417.
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    Dr. Oestenstad noted that, in the second peer-reviewed study 
submitted by Dr. Crutchfield in support of the proposed protocol, 
``[t]he distributions of fit factors [measured] by the two methods were 
shown to be almost identical, and fit factors [measured] by the 
[proposed CNP REDON protocol] were lower than those [measured] by the 
[previously approved CNP protocol] at low levels of fit'' (Ex. 4-88). 
He stated further that ``[s]tudies by my students have found that the 
negative pressure method produced a significantly lower geometric 
standard deviation than the aerosol method for a series of fit tests on 
the same subjects wearing the same mask.''
    OSHA finds that Drs. Crutchfield and Oestenstad have demonstrated 
the reliability and effectiveness of the CNP REDON protocol in 
detecting respirator leaks, and that this and similar CNP protocols 
consistently produce fit factors that are substantially lower than fit 
factors obtained using the ambient-aerosol fit testing protocol. The 
Agency considers their comments especially significant because they are 
based on data collected under controlled laboratory conditions.
    Several commenters who currently use the previously approved CNP 
protocol endorsed the proposed protocol because they believed it would 
increase the effectiveness of the fit testing by improving the ability 
of employees to detect leaks while donning and doffing a respirator, 
enhancing confidence among employees and employers that the respirators 
fit properly, and yielding fit factors that do not differ substantially 
from fit factors obtained using the previously approved CNP protocol 
(Exs. 3-5, 3-7, 3-25, and 3-46). One commenter, who used the PortaCount 
protocol, disagreed with these comments, claiming that both CNP fit 
testing protocols would diminish effectiveness by interfering with 
training employees in the capabilities and limitations of their 
respirators (Ex. 4-84). However, this commenter did not elaborate on 
the supposed interference, provide any data, or present evidence of 
experience in administering either of the CNP protocols. One commenter 
believed that existing quantitative fit tests would detect respirator 
leakage more effectively that the proposed protocol (Ex. 4-99). 
However, this commenter provided no evidence on which to base this 
claim, which the Agency finds to be unsupported by other evidence in 
the record, including the peer-reviewed studies submitted by Dr. 
Crutchfield.
    The remaining comments lend strong support to the proposed CNP 
REDON protocol in that they generally found that the proposed protocol 
would assess respirator fit effectively, and also would train employees 
to detect leakage while donning and doffing a respirator (Exs. 3-5, 3-
7, 3-25, and 3-46). The Agency agrees that the CNP REDON protocol, 
through effective fit testing and training, also will improve employee 
confidence that their respirators fit properly.
    Several commenters asserted that the redonning exercises were not 
valid (Exs. 3-32, 4-6, and 4-66). Two commenters took issue with the 
elimination of the head side-to-side, head up-and-down, and talking 
exercises from the proposed protocol, which the first of these 
commenters asserted had a history of exposing poor respirator fit (Exs. 
3-32 and 3-61). One commenter questioned the validity of the head-shake 
exercise, while another commenter stated that the two articles 
submitted in support of the proposed protocol failed to demonstrate 
that the head-shake or multiple-donning exercises would expose the same 
leaks as the head-movement exercises (Exs. 3-60 and 3-32). This second 
commenter stated further that the first peer-reviewed article submitted 
by Dr. Crutchfield in support of the proposed protocol showed that 
``the talking exercise produces consistently lower fit factors than 
other exercises for fit test methods [e.g., the ambient-aerosol and 
generated-aerosol protocols],'' but noted this exercise was impossible 
to perform under the proposed or previously approved CNP protocols (Ex. 
3-32). Two commenters questioned the validity of the breath-hold 
requirement (Exs. 3-28 and 3-61).
    OSHA notes that none of the criticisms addressing specific test 
exercises were substantiated by any data or other evidence. 
Additionally, these comments did not take into consideration the 
evidence in the record showing that the proposed protocol, even after 
eliminating these test exercises, still yields reliable and accurate 
fit factors that are consistently below (i.e., more conservative than) 
the fit factors obtained using the ambient-aerosol protocol. The 
comments regarding the validity of the redonning exercises ignore the 
important contribution these exercises make in detecting respirator 
leaks, as described in the results of the second peer-reviewed study 
submitted by Dr. Crutchfield. One of these commenters, despite 
criticizing the redonning exercise, stated elsewhere in his comments 
that he ``has no disagreement with the concept of multiple mask 
donnings as part of a respirator fit test'' (Ex. 3-32). Moreover, the 
breath-hold requirement has been validated in the studies described in 
Dr. Crutchfield's peer-reviewed articles, and is a fundamental part of 
both the proposed and previously approved CNP protocols

[[Page 46990]]

(i.e., test subjects must maintain negative pressure inside the 
respirator for the equipment to detect leakage during the various 
exercises).
    In a general criticism of the proposed protocol, several commenters 
referred to a NIOSH study in which the previously approved CNP protocol 
(and, by implication, the proposed CNP REDON protocol) performed poorly 
when test subjects were exposed to Freon as a challenge agent during 
fit testing (Exs. 3-32, 3-45, 4-91, and 4-92).\5\ However, in 
explaining the poor results obtained using the CNP protocol, NIOSH 
stated, ``[T]he possibility of changes in fit during the Freon-113 
exposure in the chamber may have placed the * * * CNP method[s] at a 
disadvantage; any change in fit during the Freon-113 exposure would 
tend to decrease the observed correlation'' (Ex. 3-32-1, p. 866).
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    \5\ Exs. 3-32-1 and 3-32-2 in the docket are copies of articles 
describing these NIOSH studies.
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4. Will the Proposed Protocol Generate Reproducible Fit Testing 
Results?
    OSHA received no comments on this issue, which suggests that 
reproducibility of the fit testing results was not a critical concern 
to the regulated community. In addition, the Agency believes that the 
consistency of results between the two peer-reviewed studies 
demonstrates that fit factors obtained using the CNP REDON protocol 
would be highly reproducible.
5. Should OSHA Expand Application of the Proposed Protocol Fit-Test 
Exercises to Other Quantitative Fit Tests (e.g., Ambient Aerosol 
Tests)?
    Dr. Oestenstad concluded that ``no studies * * * have validated the 
measurement of respirator leakage using the ambient aerosol method and 
the proposed exercise protocol,'' and cautioned that ``[a]pplication of 
the proposed exercise protocol to the ambient aerosol method would be 
scientifically inappropriate if no studies have been conducted'' (Ex. 
4-88). Another commenter, who opposed OSHA's acceptance of the 
previously approved and proposed CNP protocols, also recommended that 
``OSHA * * * accept all * * * fit testing protocols [approved under 
ANSI Z88.10-2001] including those for generated aerosol and particle 
counting (ambient aerosol) methods'' (Ex. 3-32). An additional 65 
commenters endorsed the recommendation that OSHA should approve all of 
the protocols specified by this ANSI standard, including the 
abbreviated PortaCount ambient-aerosol protocol and the ANSI provision 
that allows a 30-second exercise duration. Several commenters urged the 
Agency to reduce each of the exercises in the PortaCount ambient-
aerosol protocol to 30 seconds, while other commenters asserted that 
such a reduction would have no adverse affect on fit factors obtained 
using the PortaCount ambient-aerosol protocol (Exs. 3-34, 3-37, 3-47, 
4-18, 4-45, 4-47, 4-51, 4-53, 4-93, 4-101, and 4-112). Some commenters 
noted that the existing Canadian respirator fit testing standard (CSA 
Z94.4-02) permits 30-second fit testing exercises for the PortaCount 
ambient-aerosol protocol (Exs. 3-32, 3-62, 4-62, 4-72, and 4-114). Two 
commenters wanted to shorten the PortaCount ambient-aerosol protocol by 
removing the grimace exercise (Exs. 3-23 and 3-53).
    The Agency concurs with Dr. Oestenstad's conclusion that no studies 
are available demonstrating that the exercises developed for the 
proposed CNP REDON protocol would determine a valid fit factor if used 
in another quantitative fit testing protocol. No other commenter 
provided evidence to refute this conclusion. Regarding the remaining 
comments in the previous paragraph, the proposal did not address using 
ANSI Z88.10-2001 to justify adopting any fit testing protocol. In 
section IV.G of the proposal (``Applicability of Existing Consensus 
Standards''), OSHA referred to ANSI Z88.10-2001 for the purpose of 
comparing the proposed fit test to the CNP REDON protocol described in 
the ANSI standard; OSHA did not use this reference to substantiate the 
accuracy, reliability, or validity of the proposed protocol or any 
other fit testing protocol. The Agency uses only the criteria specified 
in Part II of Appendix A of the Respiratory Protection Standard to 
determine whether to propose a new fit testing protocol or to modify 
protocols previously approved by OSHA (e.g., reducing exercise times or 
eliminating an exercise). OSHA's Respiratory Protection Standard is 
clear on the appropriate criteria and the method for assessing a new 
protocol. The Agency cannot consider any new fit testing protocol for 
approval that does not meet these criteria, regardless of its 
acceptance under ANSI Z88.10-2001 or any other standard (e.g., the 
Canadian respirator fit testing standard (CSA Z94.4-02)).
6. Will the Proposed Editorial and Technical Revisions to Part I of 
Appendix A Improve Proper Implementation of the Approved CNP Protocol 
and the Proposed CNP REDON Protocol?
    Two commenters questioned the efficacy of the two types of breath-
hold warning devices (i.e., auditory or visual), noting that the test 
operator could continue repeating the same exercise until achieving a 
passing fit factor (Exs. 3-32 and 3-60). In addition, one of these 
commenters recommended clarifying the CNP REDON instructions to ensure 
that test subjects: do not adjust their respirator masks during fit 
testing (to increase test validity); remove their respirator masks 
completely before redonning them (to provide two distinct 
measurements); and perform a five-minute comfort-assessment period 
prior to beginning the exercises (Ex. 3-32). This commenter also noted 
that the proposal required calculating the harmonic mean of the fit 
testing results in determining a final fit factor for an employee's 
respirator; the commenter stated, ``There are very few people who know 
what a harmonic mean is. Please provide the exact equation'' (Ex. 3-
32). The commenter also asserted that the validity of the proposed 
protocol would be improved if employees had to pass both redonning 
exercises (i.e., so that high fit factors achieved on the other 
exercises would not offset poor fit factors obtained on the redonning 
exercises) (Ex. 3-32).
    OSHA agrees with the observations made by the two commenters that 
continuing a fit-test exercise after activating the breath-hold warning 
device could invalidate the fit test, which may compromise proper 
respirator selection and employee protection. Accordingly, the Agency 
has added the phrase ``and restarted from the beginning'' to the 
paragraph describing the breath-hold warning devices. The Agency 
believes that requiring operators to repeat a failed fit test (as 
indicated by activation of the breath-hold warning device) from the 
beginning will enhance the validity of the fit test and increase the 
likelihood that employees will select the correct respirator.
    In response to the comment that permitting employees to adjust 
respirators during fit testing can invalidate the results, the Agency 
is adding language to paragraph C.4(a)(6) of the CNP REDON protocol 
prohibiting respirator adjustments once the fit-test exercises begin. 
This language is consistent with the existing requirement in Appendix A 
Part I.A.14(b) for the

[[Page 46991]]

other fit testing protocols. OSHA concludes that this revision will 
increase the validity of fit testing results and the protection 
afforded to the employee by a properly fitting respirator.
    OSHA also agrees with the recommendation to clarify the 
instructions so that test subjects perform two complete redonnings. The 
revised instructions now require test subjects to remove their 
respirator masks, loosen the straps, and then redon their respirators. 
The Agency believes that this revision will ensure that each redonning 
exercise contributes independently to the overall fit-test score, 
thereby enhancing proper respirator selection. However, OSHA is not 
including in the revised instructions a description of the five-minute 
comfort-assessment period because the general instructions for 
administering fit tests, including the CNP protocol, already require 
employers to implement a comfort-assessment period prior to fit 
testing.\6\ Therefore, repeating these instructions under the section 
that describes the CNP protocols is redundant.
---------------------------------------------------------------------------

    \6\ See Appendix A, Part I, A., paragraph 14(b) of the 
Respiratory Protection Standard.
---------------------------------------------------------------------------

    The Agency agrees with the commenter who recommended that 
delineating a specific method for calculating a harmonic mean would be 
useful in accurately calculating fit factors from the results of the 
CNP REDON protocol. OSHA believes that using such a method would save 
time in making these calculations and, additionally, would reduce 
errors in determining fit factors. While the commenter did not identify 
in his comments a procedure for calculating a harmonic mean, the Agency 
has selected for this purpose a method similar to the one described in 
the ANSI Z88.10-2001 standard. The ANSI calculation method is accepted 
generally by the industrial-hygiene community, and it also is the 
method required in Appendix A of OSHA's Respiratory Protection Standard 
for determining fit factors using the results of the ambient-aerosol 
protocol.
    OSHA is not persuaded that test subjects need to pass both 
redonning exercises so that the contribution of these exercises would 
not be offset by the other exercises, including the head-shaking and 
bending-over exercises. As is true for all quantitative fit testing 
protocols including the CNP REDON protocol, it is the fit factor 
obtained by averaging all of the fit-test scores obtained during fit 
testing that is important in assessing respirator fit, not the test 
score obtained from individual fit tests. OSHA currently does not 
impose a requirement that other quantitative fit tests listed in 
Appendix A of the Respiratory Protection Standard must have test 
subjects pass every fit testing exercise, and no evidence was submitted 
by the commenter to suggest that such a revision is necessary for the 
CNP REDON protocol.

D. Conclusions

    After reviewing the comments submitted to the record, the Agency 
finds that the proposed CNP REDON protocol is supported by peer-
reviewed studies that were well controlled, conducted according to 
accepted experimental design practices and principles, and that 
produced results that were properly, fully, and fairly presented and 
interpreted. In addition, based on the studies and the comments in the 
record, the Agency concludes that the proposed protocol will 
effectively and reliably identify respirators with unacceptable fit as 
well as other quantitative fit tests previously approved by OSHA, and 
also will generate reproducible fit testing results. Moreover, the 
proposed fit testing exercises are specific to the CNP REDON protocol, 
and no evidence is available in the rulemaking record to support 
applying the exercises to other quantitative fit tests previously 
approved by OSHA. The record also indicates that the editorial and 
technical revisions described in the proposal are appropriate. 
Additionally, the Agency adopted several other technical and editorial 
revisions recommended by commenters; OSHA believes these revisions will 
ensure proper selection of respirators for employee use.

III. Procedural Determinations

A. Legal Considerations

    OSHA's Respiratory Protection Standard is based on evidence that 
fit testing is necessary to ensure proper respirator fit for employees; 
proper respirator fit, in turn, protects employees against excessive 
exposure to airborne contaminants in the workplace. Employers covered 
by this revision 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 fit testing provisions currently 
are protecting their employees from the significant risk that results 
from poorly fitting respirators. For this final standard, the Agency 
has determined that the new CNP REDON fit testing protocol provides 
employees with protection that is comparable to the protection afforded 
to them by the existing fit testing provisions. In this regard, the CNP 
REDON protocol is not expected to replace existing fit testing 
protocols, but instead is an alternative to them. Therefore, OSHA finds 
that the final standard does not directly increase or decrease the 
protection afforded to employees, nor does it increase employers' 
compliance burdens.

B. Economic Analysis and Regulatory Flexibility Certification

    The final standard is not a significant rulemaking under Executive 
Order 12866, or a ``major rule'' under the Unfunded Mandates Reform Act 
of 1995 (2 U.S.C. 1501) or Section 801 of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 601). The final standard 
imposes 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 the Executive Order or relevant statutes.
    The CNP REDON protocol offers employers an additional option to fit 
test their employees for respirator use. In addition to the CNP 
protocol previously approved by OSHA, which continues to be an option, 
the Agency is adding the CNP REDON protocol. According to a recent 
NIOSH-BLS survey of respirator use, approximately 25,000 of 282,000 
establishments currently use the previously approved CNP protocol (see 
Ex. 6-3, Docket H-049C). With this final rule, employers now have a 
choice between the previously approved CNP protocol consisting of eight 
exercises, including one redonning of the respirator, or the new CNP 
REDON protocol, which involves three exercises and two redonnings of 
the respirator.
    By providing regulatory flexibility to employers, the addition of 
the CNP REDON protocol may reduce their costs in terms of decreasing 
the time required to fit test their employees for respirator use. In 
this regard, OSHA assumes that some employers who now use the 
previously approved CNP protocol will adopt the CNP REDON protocol. A 
number of employers who are purchasing new or replacement equipment for 
administering fit tests also will select the CNP REDON protocol because 
it consists of fewer exercises than the previously approved CNP and 
ambient-aerosol protocols, thereby decreasing the time and cost 
required for them to fit test their employees. However, the Agency 
believes that the CNP REDON protocol approved under this rulemaking is 
unlikely to be adopted by employers who currently use the ambient-
aerosol

[[Page 46992]]

protocols because these employers already have made an equipment and 
training investment to administer these fit testing protocols. Finally, 
OSHA has included the screen tracing in the previously approved CNP and 
CNP REDON protocols as a visual warning device to detect non-compliance 
by employees being fit tested with the breath-hold procedure required 
by these protocols. The Agency concludes that this tracing adds no cost 
burden to employers who use these protocols because, as noted earlier, 
the manufacturer already provides this capability on the CNP test 
equipment.
    In summary, OSHA concludes that this rulemaking imposes no 
additional costs on employers. Accordingly, OSHA certifies that this 
rulemaking has no significant impact on a substantial number of small 
businesses. Therefore, the Agency has not prepared a Final Regulatory 
Flexibility Analysis.

C. Paperwork Reduction Act

    After analyzing the fit testing provisions of this final rule in 
terms of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. 
and 5 CFR part 1320), OSHA determined that these provisions do 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 the existing 
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 strip chart recording or other recording of 
the test results. The employer must maintain this record until the next 
fit test is administered. However, this paperwork requirement remains 
the same whether employers use the other fit testing protocols already 
listed in Part I of Appendix A of the Respiratory Protection Standard, 
or implement the CNP REDON fit testing protocol instead. Therefore, use 
of the CNP REDON protocol in the context of the existing fit testing 
protocols does not require an additional paperwork-burden determination 
because OSHA already accounted for this burden during the final 
rulemaking for the Respiratory Protection Standard (see 63 FR 1152-
1154; OMB Control Number 1218-0099).
    OSHA solicited comments on this determination in the June 6, 2003 
Federal Register (68 FR 33891). The Agency did not receive any public 
comments questioning this determination. Therefore, OSHA concludes that 
the final rule does not add any burden hours to the existing 
collection-of-information requirements associated with fit testing for 
employees for respirator use.

D. Federalism

    The Agency reviewed the final standard revision according to the 
most recent Executive Order on Federalism (Executive Order 13132, 64 FR 
43225, August 10, 1999). This Executive Order 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 Executive 
Order allows Federal agencies to preempt state law only with the 
expressed consent of Congress. In such cases, Federal agencies must 
limit preemption of state law to the extent possible.
    Under section 18 of the Occupational Safety and Health Act of 1970 
(OSH Act), Congress 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 OSH Act. 
Accordingly, section 18 of the OSH 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 
(i.e., is a State-plan State). (See Gade v. National Solid Wastes 
Management Association, 112 S. Ct. 2374 (1992).) Therefore, with 
respect to states that do not have OSHA-approved plans, the Agency 
concludes that this revision conforms to the preemption provisions of 
the OSH Act. Additionally, section 18 of the OSH Act prohibits states 
without approved plans from issuing citations for violations of OSHA 
standards; the Agency finds that the final rulemaking does not expand 
this limitation.
    OSHA has authority under Executive Order 13132 to add the CNP REDON 
fit testing protocol to its Respiratory Protection Standard at 29 CFR 
1910.134 because the problems addressed by these requirements are 
national in scope. In this regard, the revision offers hundreds of 
thousands of employers across the nation an opportunity to adopt an 
additional protocol to use in assessing respirator fit among their 
employees. Therefore, the revision would provide employers in every 
state with an alternative means of complying with the fit testing 
requirements specified in paragraph (f) of OSHA's Respiratory 
Protection Standard.

E. State Plans

    Section 18(c)(2) of the OSH Act (29 U.S.C. 667(c)(2)) requires 
State-plan States to adopt mandatory standards promulgated by OSHA. 
However, compliance with the CNP REDON protocol provides employers with 
an alternative to the existing requirements for fit testing protocols 
specified in its Respiratory Protection Standard; therefore, the 
alternative is not, itself, a mandatory standard. Accordingly, State-
plan States are not obligated to adopt the final provisions that result 
from this rulemaking. Nevertheless, OSHA strongly encourages the 24 
states and two territories with their own State plans to revise their 
current Respiratory Protection Standard to adopt the CNP REDON fit 
testing protocol based on this final rulemaking.
    OSHA believes that adopting this revision would provide employers 
in the State-plan states and territories with economic benefits that 
may accrue from its enactment, while protecting the safety and health 
of employees who use respirators against airborne hazardous substances 
in the workplace. These State-plan states and territories are: Alaska, 
Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, 
Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto 
Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, 
and Wyoming. Connecticut, New Jersey, New York, and the Virgin Islands 
have OSHA-approved State Plans that apply to state and local government 
employees only.

F. Unfunded Mandates

    OSHA reviewed the revision according to the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) and Executive Order 
12875. As discussed above in section IV.B (Preliminary Economic 
Analysis and Regulatory Flexibility Certification) of this preamble, 
the Agency has made a determination that the revision imposes no 
additional costs on any private or public sector entity. The 
substantive content of the revision applies only to employers whose 
employees use respirators for protection against airborne workplace 
contaminants, and compliance with the revision would be strictly 
optional for these employers. Accordingly, the revision would require 
no additional

[[Page 46993]]

expenditures by either public or private employers.
    The Agency's standards do not apply to state and local governments, 
except in states that have voluntarily elected to adopt a State Plan 
approved by the Agency. Consequently, the revision does not meet the 
definition of a ``Federal intergovernmental mandate'' (see section 
421(5) of the UMRA (2 U.S.C. 658(5)). In conclusion, the revision does 
not mandate that state, local, and tribal governments adopt new, 
unfunded regulatory obligations.

G. Applicability of Existing Consensus Standards

    When OSHA promulgated its original respirator fit testing protocols 
on January 8, 1998, under Appendix A of its final Respiratory 
Protection Standard (29 CFR 1910.134), no national consensus standards 
addressed these protocols. However, the American National Standards 
Institute (ANSI) subsequently developed a national consensus standard 
on fit testing protocols as an adjunct to its respiratory-protection 
program, ANSI Z88.2-1992. ANSI approved this national consensus 
standard, entitled ``Respirator Fit Testing Methods,'' on June 8, 2001 
as ANSI Z88.10-2001.
    Paragraph 7.3 of ANSI Z88.10-2001 provides the requirements for 
conducting the CNP fit test, including requirements for test 
instrumentation and administering the fit test; these requirements are 
consistent with the CNP fit testing requirements specified in 1998 by 
OSHA in Part I.C.4 of its Respiratory Protection Standard. In addition, 
section 9 and Table 1 of ANSI Z88.10-2001 describe the exercises 
required during CNP fit testing; these required exercises duplicate the 
exercises described in the CNP REDON protocol, except that the second 
respirator redonning is optional under the ANSI standard.\7\ However, 
paragraph 9.2 of the ANSI standard specifies that one optional exercise 
must be included with the required exercises.
---------------------------------------------------------------------------

    \7\ Other optional exercises include deep breathing, side-to-
side head movement, up-and-down head movement, stepping up and down, 
a second normal breathing exercise, grimacing followed by normal 
breathing, painter or sand-blaster movements, and other job-specific 
movements.
---------------------------------------------------------------------------

    OSHA concludes that the CNP REDON protocol adopted in this 
rulemaking closely matches the requirements of the recent ANSI Z88.10-
2001 standard. The CNP REDON protocol relies on the CNP test procedures 
and instrumentation described in paragraphs (a) and (c) of Part I.C.4 
in Appendix A of the Respiratory Protection Standard, which are similar 
to requirements specified in paragraph 7.3 of the ANSI standard. Any 
differences between these OSHA requirements and the provisions of the 
ANSI standard appear to be minor. Additionally, the fit testing 
exercises in the CNP REDON protocol are the same exercises described in 
the ANSI standard when a second respirator redonning is selected as the 
optional exercise. OSHA also is requiring employers who use the CNP 
REDON protocol to calculate fit factors using the harmonic-mean 
equation provided in the final rule; this equation is consistent with 
the equation described for the ambient-aerosol protocol in Appendix A 
of OSHA's Respiratory Protection Standard.

H. List of Subjects in 29 CFR Part 1910

    Hazardous substances; Health; Occupational safety and health; 
Quantitative fit testing; Respirators; Respirator selection.

I. Authority and Signature

    John L. Henshaw, 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 this final rule 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 107, 
Contract Work Hours and Safety Standards Act (Construction Safety Act; 
40 U.S.C. 333); Section 41, Longshore and Harbor Worker's Compensation 
Act (33 U.S.C. 941); Secretary of Labor's Order No. 5-2002 (67 FR 
65008); and 29 CFR part 1911.

    Signed at Washington, DC on July 29, 2004.
John L. Henshaw,
Assistant Secretary of Labor.

IV. Amendments to the Standard

0
For the reasons stated in the preamble, the Agency amends 29 CFR part 
1910 as follows:

PART 1910--[AMENDED]

Subpart I--[Amended]

0
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 107, 
Contract Work Hours and Safety Standards Act (the Construction 
Safety Act; 40 U.S.C. 333); Section 41, Longshore and Harbor 
Worker's Compensation Act (33 U.S.C. 941); and Secretary of Labor's 
Order Nos. 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 
9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), or 5-2002 (67 FR 
65008), 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.


0
2. Amend Part I in Appendix A to Sec.  1910.134 as follows:

0
A. In Section A, revise the introductory text of paragraph 14(a).

0
B. In Section C, paragraph 4, 8th sentence, remove the name ``Dynatech 
Nevada'' and add, in its place, ``Occupational Health Dynamics of 
Birmingham, Alabama.''

0
C. In Section C, revise paragraphs 4(a)(5) and (6).

0
D. In Section C, revise paragraph 4(c)(1).

0
E. In Section C, add paragraph 5 at the end of Part I.
    The revised and added text reads as follows:


Sec.  1910.134  Respiratory protection.

* * * * *

Appendix A to Sec.  1910.134: Fit Testing Procedures (Mandatory)

* * * * *

Part I. OSHA--Accepted Fit Testing Protocols

A. Fit Testing Procedures--General Requirements

* * * * *
    14. Test Exercises. (a) Employers must perform the following 
test exercises for all fit testing methods prescribed in this 
appendix, except for the CNP quantitative fit testing protocol and 
the CNP REDON quantitative fit testing protocol. For these two 
protocols, employers must ensure that the test subjects (i.e., 
employees) perform the exercise procedure specified in Part I.C.4(b) 
of this appendix for the CNP quantitative fit testing protocol, or 
the exercise procedure described in Part I.C.5(b) of this appendix 
for the CNP REDON quantitative fit-testing protocol. For the 
remaining fit testing methods, employers must ensure that employees 
perform the test exercises in the appropriate test environment in 
the following manner:
* * * * *
    C. * * *
* * * * *
    (4) * * *
    (a) * * *
* * * * *
    (5) The employer must train the test subject to hold his or her 
breath for at least 10 seconds.
    (6) The test subject must don the test respirator without any 
assistance from the test administrator who is conducting the CNP fit 
test. The respirator must not be adjusted once the fit-test 
exercises begin. Any adjustment voids the test, and the test subject 
must repeat the fit test.
* * * * *

[[Page 46994]]

    (c) * * *
    (1) The test instrument must have an effective audio-warning 
device, or a visual-warning device in the form of a screen tracing, 
that indicates when the test subject fails to hold his or her breath 
during the test. The test must be terminated and restarted from the 
beginning when the test subject fails to hold his or her breath 
during the test. The test subject then may be refitted and retested.
* * * * *
    5. Controlled negative pressure (CNP) REDON quantitative fit 
testing protocol.
    (a) When administering this protocol to test subjects, employers 
must comply with the requirements specified in paragraphs (a) and 
(c) of Part I.C.4 of this appendix (``Controlled negative pressure 
(CNP) quantitative fit testing protocol''), as well as use the test 
exercises described below in paragraph (b) of this protocol instead 
of the test exercises specified in paragraph (b) of Part I.C.4 of 
this appendix.
    (b) Employers must ensure that each test subject being fit 
tested using this protocol follows the exercise and measurement 
procedures, including the order of administration, described below 
in Table A-1 of this appendix.

         Table A-1.--CNP REDON Quantitative Fit Testing Protocol
------------------------------------------------------------------------
                                                           Measurement
         Exercises\1\             Exercise procedure        procedure
------------------------------------------------------------------------
Facing Forward................  Stand and breathe       Face forward,
                                 normally, without       while holding
                                 talking, for 30         breath for 10
                                 seconds.                seconds.
Bending Over..................  Bend at the waist, as   Face parallel to
                                 if going to touch his   the floor,
                                 or her toes, for 30     while holding
                                 seconds.                breath for 10
                                                         seconds
Head Shaking..................  For about three         Face forward,
                                 seconds, shake head     while holding
                                 back and forth          breath for 10
                                 vigorously several      seconds
                                 times while shouting.
REDON 1.......................  Remove the respirator   Face forward,
                                 mask, loosen all        while holding
                                 facepiece straps, and   breath for 10
                                 then redon the          seconds.
                                 respirator mask.
REDON 2.......................  Remove the respirator   Face forward,
                                 mask, loosen all        while holding
                                 facepiece straps, and   breath for 10
                                 then redon the          seconds.
                                 respirator mask again.
------------------------------------------------------------------------
\1\ Exercises are listed in the order in which they are to be
  administered.

    (c) After completing the test exercises, the test administrator 
must question each test subject regarding the comfort of the 
respirator. When a test subject states that the respirator is 
unacceptable, the employer must ensure that the test administrator 
repeats the protocol using another respirator model.
    (d) Employers must determine the overall fit factor for each 
test subject by calculating the harmonic mean of the fit testing 
exercises as follows:
[GRAPHIC] [TIFF OMITTED] TR04AU04.001

Where:

N = The number of exercises;
FF1 = The fit factor for the first exercise;
FF2 = The fit factor for the second exercise; and
FFN = The fit factor for the nth exercise.

[FR Doc. 04-17765 Filed 8-3-04; 8:45 am]
BILLING CODE 4510-26-P