[Federal Register Volume 68, Number 109 (Friday, June 6, 2003)]
[Proposed Rules]
[Pages 33887-33894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13748]


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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: Notice of proposed rulemaking and request for comments.

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SUMMARY: OSHA is proposing to approve an additional controlled negative 
pressure (CNP) fit testing protocol for its Respiratory Protection 
Standard. The proposed protocol would affect OSHA respiratory 
protection standards for shipyard employment and construction. The 
proposed protocol is referred to as the CNP REDON fit testing protocol. 
Provisions contained in OSHA's current Respiratory Protection Standard 
allow individuals to propose additional fit testing protocols. This 
proposed revision is based on a new quantitative fit testing protocol 
submitted to OSHA for addition to the standard.
    The proposed protocol requires three different test exercises 
followed by two

[[Page 33888]]

redonnings of the respirator, while the currently approved CNP protocol 
specifies eight test exercises, including one redonning of the 
respirator. In addition to amending the Respiratory Protection Standard 
to include the proposed protocol, this rulemaking is proposing to make 
several editorial and non-substantive technical revisions to this 
standard associated with the proposed protocol and the approved CNP 
protocol.

DATES: Submit written comments regarding this proposal, including 
comments on the information-collection determination described in 
section IV.C (Paperwork Reduction Act) of this notice, by the following 
dates:
    Hard copy. Submitted (postmarked or sent) by September 4, 2003.
    Facsimile and electronic transmission. Sent by September 4, 2003.
    Please see the section below entitled SUPPLEMENTARY INFORMATION for 
additional information on submitting written comments.

ADDRESSES: Submit comments and attachments to comments using one of the 
procedures described below:
    Regular mail, express delivery, hand-delivery, and messenger 
service. Submit three copies of written comments and attachments to the 
OSHA Docket Office, Docket No. H-049D, Technical Data Center, Room N-
2625, U.S. Department of Labor, 200 Constitution Ave., NW., Washington, 
DC 20210; telephone (202) 693-2350. OSHA Docket Office and Department 
of Labor hours of operation are 8:15 a.m. to 4:45 p.m., EST.
    Please note that security-related problems may result in 
significant delays in receiving comments and other written materials by 
regular mail. Telephone the OSHA Docket Office at (202) 693-2350 for 
information regarding security procedures associated with delivery of 
materials by express delivery, hand delivery, and messenger service.
    Facsimile. Transmit written comments (including attachments) 
consisting of 10 or fewer pages by facsimile to the OSHA Docket Office 
at (202) 693-1648. You must include the docket number of this notice, 
Docket No. H-049D, in your comments.
    Electronic. You may submit comments electronically through the 
Internet on OSHA's Homepage at http://ecomments.osha.gov. If you would 
like to submit additional studies or journal articles, you must submit 
three copies of them to the OSHA Docket Office at the address above. 
These materials must clearly identify your electronic comments by name, 
date, subject, and docket number so we can attach them to your 
comments.
    All comments and submissions will be available for inspection and 
copying in the OSHA Docket Office at the address above. Comments and 
submissions posted on OSHA's web page will be available at http://www.osha.gov. Contact the OSHA Docket Office at (202) 693-2350 for 
information about materials not available on the OSHA web page and for 
assistance in using this web page to locate docket submissions. Because 
comments sent to the docket or to OSHA's web page are available for 
public inspection, the Agency cautions against including in these 
comments personal information such as social security numbers and birth 
dates.

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 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 website 
(http://www.osha.gov), and select ``Federal Register,'' ``Date of 
Publication,'' and then ``2003.''

SUPPLEMENTARY INFORMATION: 

I. Background

    The Respiratory Protection Standard currently includes three (3) 
quantitative fit testing protocols: Generated aerosol fit testing 
protocol; ambient aerosol condensation nuclei counter (CNC) fit testing 
protocol; and controlled negative pressure (CNP) fit testing protocol. 
The standard specifies the procedure to be followed to add new test 
protocols as they are developed and validated. The criteria for 
determining that a fit testing protocol is valid 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. When a protocol 
meets such criteria, OSHA conducts a notice-and-comment rulemaking 
under Section 6(b)(7) of the Occupational Safety and Health Act of 
1970. OSHA believes the CNP REDON meets these criteria as described 
below.

II. Summary and Explanation of the Proposal

    Introduction. In his letter submitting the protocol for review, Dr. 
Crutchfield included copies of two peer-reviewed articles from 
industrial hygiene journals describing the accuracy and reliability of 
the CNP REDON fit testing protocol. (See Exs. 2 and 3; Section III 
below provides complete reference information on these articles.) 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 
controlled negative pressure (CNP) fit testing protocol developed by 
Dr. Crutchfield in the early 1990s, which OSHA approved for inclusion 
in Part I.C of Appendix A when the Agency developed the final 
Respiratory Protection Standard. The proposed protocol uses the same 
fit test requirements and test instrumentation specified for the CNP 
fit testing protocol in paragraphs (a) and (c) of Part I.C.4 of 
Appendix A of this standard. However, the proposed protocol includes 
only three test exercises followed by two redonnings of the respirator, 
instead of the eight test exercises and one respirator redonning 
required in paragraph (b) of the CNP fit testing protocol. The three 
tests, 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:
    [sbull] Facing forward. In a normal standing position, without 
talking, the test participant shall breathe normally; then, while 
facing forward, he/she shall hold his/her breath for 10 seconds for 
test measurement.
    [sbull] Bending over. The test participant shall bend at the waist 
as if he/she is going to touch his/her toes; then, while facing 
parallel to the floor, he/she shall hold his/her breath for 10 seconds 
for test measurement.
    [sbull] Head shaking. The test participant shall shake his/her head 
back and forth vigorously several times while shouting for 
approximately three seconds; then, while facing forward, he/she shall 
hold his/her breath for 10 seconds for test measurement.
    [sbull] First redonning (REDON-1). The test participant shall 
remove and redon the respirator mask; after redonning the

[[Page 33889]]

mask, he/she shall face forward and hold his/her breath for 10 seconds 
for test measurement.
    [sbull] Second redonning (REDON-2). The test participant shall 
remove and redon the respirator mask again; after redonning the mask, 
he/she shall face forward and hold his/her breath for 10 seconds for 
test measurement.
    As noted earlier, Dr. Crutchfield submitted two peer-reviewed 
journal articles that provided information on the accuracy and 
reliability of the proposed CNP REDON fit testing protocol. In the 
first of these articles, the most important conclusion made by the 
authors is that the proposed CNP REDON fit testing protocol results in 
substantially lower respirator fit factors overall than the most 
commonly used ambient aerosol (AA) fit testing protocol. Accordingly, 
lower fit factors indicate that the proposed protocol would detect more 
respirator leaks than the AA 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 is that the 
overall fit factors obtained from the three exercises and two 
redonnings required by the proposed protocol are the same as the 
overall fit factors found when using the eight-exercise CNP protocol 
described in the Respiratory Protection Standard. Therefore, compared 
to the eight-exercise CNP protocol, the same overall fit factors can be 
obtained in less time using the proposed protocol.
    Peer-reviewed articles. In the first peer-reviewed article, 
entitled ``Effect of exercise and mask donning on measured respirator 
fit'' and published in Applied Occupational and Environmental Hygiene, 
Dr. Crutchfield and his colleagues tested 14 Air Force personnel who 
wore elastomeric full facepiece or half mask air purifying respirators 
while being fit tested using either AA fit testing equipment (the 
Portacount Plus[reg], manufactured by TSI, Inc., St. Paul, MN) or CNP 
fit testing equipment (FitTester 3000[reg], manufactured by 
Occupational Health Dyanmics, Birmingham, AL) (Ex. 2). The study 
participants wore their usual respirator mask for half of the tests 
(mask 1), and a respirator mask that was either a size larger or 
smaller than their usual mask for the other half of the tests (mask 2). 
The purpose of using the second mask was to obtain poor respirator fit 
(i.e., to ensure respirator leakage on some of the tests). Each study 
participant received three fit tests per day for five consecutive days; 
they removed and redonned the respirator between fit tests. During a 
fit test, they engaged in one of two test-exercise procedures. The 
first procedure (procedure 1) consisted of the three test exercises 
described in the proposed protocol (i.e., facing forward, bending over, 
and head shaking), with no repeated donnings. The second procedure 
(procedure 2) consisted of the following nine exercises (listed in 
order of administration): Normal breathing; deep breathing; side-to-
side head turning (pausing to inhale at each extreme position); up-and-
down head nodding (pausing to inhale at each extreme position); talking 
loudly (reading a standard passage, counting backward from 100, or 
reciting a memorized poem or song ); grimacing (contracting the facial 
muscles); bending over (as if touching the toes); jogging in place; and 
normal breathing. Only the first AA fit test administered each day with 
each mask (1 and 2) used the second test-exercise procedure; the 
remaining AA fit tests, and all of the CNP fit tests, used the first 
test-exercise procedure.
    The authors used the AA fit test equipment to compare fit factors 
for both procedures 1 and 2 under the two mask conditions. This 
comparison showed that, for mask 1, the log-transformed median overall 
fit factor obtained under procedure 1 was significantly lower than it 
was for procedure 2, while no significant difference was found between 
the procedures for mask 2. Additionally, the authors compared fit 
factors obtained from the two types of fit test equipment (i.e., CNP 
and AA) under procedure 1. Accordingly, they found that the log-
transformed median fit factors obtained using either type of equipment 
did not differ significantly among the three test exercises (i.e., 
facing forward, bending over, and head shaking) for mask 1. However, 
for mask 2, the data obtained using both types of equipment showed that 
the bending over test exercise resulted in a significantly lower log-
transformed mean fit factor than was obtained using the normal 
breathing test exercise.
    Assessing the fit factors for procedure 2 using the AA fit test 
equipment, the authors found that the talking exercise resulted in a 
significantly lower log-transformed mean fit factor than the fit factor 
determined using the normal breathing exercise for mask 1; for mask 2, 
the log-transformed mean fit factors for both the talking and bending 
over exercises were significantly lower than the fit factor obtained 
for the normal breathing exercise. A subsequent analysis showed that 
the initial normal breathing exercise, as well as the bending over and 
the head shaking exercises, accounted for most of the fit testing 
failures. Finally, after collapsing the data across mask conditions and 
exercise procedures, the authors found that the log-transformed median 
fit factor for the CNP equipment was significantly lower than the log-
transformed median fit factor for the AA equipment.
    The authors concluded that the results obtained using the AA 
equipment showed that the three exercises in procedure 1 were as 
effective in determining poor mask fit as the nine exercises that 
composed procedure 2. In reaching this conclusion, they specifically 
discounted the talking exercise, which was assessed in this study using 
only the AA equipment. In doing so, they asserted that the prolonged 
exhalation associated with the talking exercise may increase particle 
migration from the lungs to the sampling probe, which would cause the 
probe to detect an increase in particle concentration; consequently, 
the talking exercise likely results in artificially low fit factors. 
They also concluded that CNP equipment used with the three exercises in 
procedure 1 detected more poorly fitting masks than AA equipment used 
with either exercise procedure. The authors noted as well that the 
study participants took substantially less time to perform the three 
exercises in procedure 1 than the nine exercises in procedure 2, 
regardless of the type of equipment used.
    The second peer-reviewed article, entitled ``A faster, more 
rigorous protocol for fit testing emergency response respirators'' and 
published in Semiconductor Safety Association Journal, describes a 
study in which 511 firefighters were fit tested for the Scott Model AV-
2000 self-contained breathing apparatus using CNP fit testing equipment 
(Ex. 3). To detect respirator leakage, the authors converted the 
respirator, which normally operates at positive pressure, to operate in 
the negative pressure mode. During fit testing, the firefighters 
performed one of two exercise procedures. The first exercise procedure 
(procedure 1), administered to 407 firefighters, consisted of the full 
complement of exercises described in the proposed protocol (i.e., 
facing forward, bending over, head shaking, and two mask redonnings). 
The second procedure (procedure 2), administered to 104 of the 
firefighters, replicated the CNP test exercises listed in Part I.4(b) 
of Appendix A in the Respiratory Protection Standard, including (listed 
in order of administration): Normal breathing; deep breathing; side-to-
side head turning (pausing to inhale at each extreme position); up-and-
down head nodding (pausing to inhale at each

[[Page 33890]]

extreme position); talking (reading a standard passage, counting 
backward from 100, or reciting a memorized poem or song); grimacing 
(contracting the facial muscles); bending over (as if touching the 
toes); and breathing normally (remove and redon the respirator mask, 
then breathe normally). In addition, the authors used a short screening 
procedure to identify firefighters who could not pass the a complete 
fit testing protocol. Eighty-five (85) of the firefighters in procedure 
1 (20.9%) and 30 of the firefighters in procedure 2 (28.8%) did not 
pass this screening test.
    Comparisons among the firefighters who completed a fit testing 
protocol showed that the log-transformed median overall fit factor did 
not vary significantly between the two exercise procedures. However, 
after plotting the overall fit factors of the individual firefighters 
for the two exercises (i.e., one plot for each exercise), the authors 
noted that the overall fit factors for procedure 1 were substantially 
less than the fit factors for procedure 2 at the low end of the two 
distributions. They interpreted this difference as indicating that the 
fit factors obtained using procedure 1 were more conservative (i.e., 
lower) than the fit factors obtained for procedure 2 at lower levels of 
respirator fit. Based on these results, the authors concluded that the 
two exercise procedures resulted in similar fit factors, and that 
procedure 1, with three exercises and two respirator redonnings, took 
substantially less time to administer than procedure 2, with eight 
exercises (including one redonning).
    Editorial and technical revisions to the Respiratory Protection 
Standard. In addition to proposing the CNP REDON fit testing protocol, 
this rulemaking is proposing to make several editorial and technical 
revisions to the Respiratory Protection Standard. The first editorial 
revision would add the proposed CNP REDON protocol to the exception 
already specified for the approved CNP protocol under paragraph 14(a) 
of Part I.A in Appendix A of the Standard. Accordingly, paragraph 14(a) 
would except both the approved CNP protocol and the CNP REDON protocol 
from the test exercises specified for the other approved fit testing 
protocols listed in the appendix. OSHA believes that this revision is 
necessary because the proposed protocol consists of a test exercise 
procedure that differs substantially from the procedure required for 
the other approved fit testing protocols.
    The second editorial revision involves the introductory paragraph 
describing the CNP protocol under Part I.C.4 of Appendix A. 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 is proposing 
to revise this sentence to identify the current manufacturer of this 
instrument.
    In an earlier comment to OSHA (Ex. 14), Dr. Crutchfield noted 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. While using the screen tracing 
for this purpose was not part of the CNP protocol approved earlier by 
OSHA, the Agency believes that such a visual warning device would be 
useful in measuring respirator fit under both the approved CNP protocol 
and the proposed CNP REDON protocol. Therefore, OSHA is proposing to 
revise paragraph (c) of the approved CNP protocol (under Part I.A.4 of 
the standard) to include the screen tracing currently provided on the 
CNP test instrument as a visual warning device to detect 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 OSHA's description of 
the CNP fit test requirements in paragraphs (a)(2) and (a)(5) of the 
approved CNP protocol contained several errors (Ex. 8). In this regard, 
the default test pressure in paragraph (a)(2) should read -15 (not -
1.5) mm of water, while the breath hold requirement in paragraph (a)(5) 
should be 10 (not 20) seconds. Accordingly, the Agency is proposing to 
revise these parameters because implementing correct fit test 
procedures will improve the assessment of respirator fit factors using 
the approved CNP protocol, as well as the proposed CNP REDON protocol 
should the Agency approve it in a final rulemaking.
    Conclusions. OSHA believes that the information submitted by Dr. 
Crutchfield in support of the proposed protocol meets the criteria for 
proposed fit testing protocols established by the Agency in Part II of 
Appendix A of the Respiratory Protection Standard. Therefore, the 
Agency concludes that the proposed protocol warrants notice-and-comment 
rulemaking under Section 6(b)(7) of the OSH Act, and is initiating this 
rulemaking to determine whether to approve the proposed protocol for 
inclusion in Part I of Appendix A of the standard. However, because the 
only difference between the proposed protocol and the existing CNP 
protocol in Part I.C.4 of Appendix A is the exercise procedure used 
during fit testing, the Agency is limiting the proposed regulatory text 
(see section V below) to a description of the exercise procedure, and 
is referring to paragraphs (a) and (c) of Part I.C.4 for information on 
the CNP fit test requirements and the CNP test instrument. In addition, 
if approved, the protocol would be an alternative to the existing 
quantitative fit testing protocols already listed in the Part I of 
Appendix A; employers would be free to select this alternative or to 
continue using any of the other protocols currently listed in the 
appendix. The Agency also believes that the proposed editorial and 
technical revisions to Part I of Appendix A are necessary for proper 
implementation of both the approved CNP protocol and the proposed CNP 
REDON protocol.
    Issues for public comment. OSHA invites comments and data from the 
public 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 will protect employees 
from airborne contaminants in the workplace. Specifically, the Agency 
invites public comment on the following issues:
    [sbull] Were the studies described in the peer-reviewed articles 
well controlled, and conducted according to accepted experimental 
design practices and principles?
    [sbull] Were the results of the studies described in the peer-
reviewed articles properly, fully, and fairly presented and 
interpreted?
    [sbull] 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?
    [sbull] Will the proposed protocol generate reproducible fit 
testing results?
    [sbull] Should OSHA expand application of the proposed protocol fit 
test exercises to other quantitative fit tests (e.g., ambient aerosol 
tests)?
    [sbull] 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?

III. References

    The preamble to this proposal cites the following references:
    (1) Crutchfield C.D., E.O. Fairbank, and S.L. Greenstein. ``Effect 
of exercise

[[Page 33891]]

and mask donning on measured respirator fit.'' Applied Occupational and 
Environmental Hygiene, vol. 14 (no. 12), pages 827-837, 1999. (See Ex. 
2.)
    (2) Crutchfield, C.D., W.F. Peate, and D.W. Kautz. ``A faster, more 
rigorous protocol for fit testing emergency response respirators.'' 
Semiconductor Safety Association Journal,\1\ vol. 13 (no. 4), pages 23-
29, 1999. (See Ex. 3.)
    Copies of these references are available from the OSHA's Docket 
Office, Room N-2625, U.S. Department of Labor, 200 Constitution Avenue, 
N.W., Washington, DC 20210; telephone (202) 693-2350 or facsimile (202) 
693-1648.
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    \1\ Now the Semiconductor Environmental Safety and Health 
Association Journal.
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IV. Procedural Determinations

A. Legal Considerations

    Employers covered by this proposal already must comply with the fit 
testing requirements specified in paragraph (f) of OSHA's Respiratory 
Protection Standard at 29 CFR 1910.134. Accordingly, these provisions 
currently are protecting their employees from the significant risk that 
results from poorly fitting respirators. For this proposal, the Agency 
preliminarily determined that the new CNP 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 
proposal is not expected to replace existing fit testing protocols, but 
instead would be an alternative to them. Therefore, OSHA preliminarily 
finds that the proposal would not directly increase or decrease the 
protection afforded to employees, nor would it increase employers' 
compliance burdens. As demonstrated in the following section, the 
proposal may reduce employers' compliance burdens by decreasing the 
time required for fit testing respirators for employee use.

B. Preliminary Economic Analysis and Regulatory Flexibility 
Certification

    The proposal 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 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 the Executive Order or relevant statutes.
    The proposal offers employers an additional option to fit test 
their employees for respirator use. In addition to the existing CNP 
protocol, which would continue to be an option, the Agency would add 
the CNP REDON protocol as a supplemental option. According to a recent 
NIOSH-BLS survey of respirator use, approximately 25,000 establishments 
currently use the existing CNP fit testing protocol out of some 282,000 
establishments requiring respirator use (Ex. 6-3, Docket H-049C). 
Employers would have a choice between the existing protocol consisting 
of eight exercises, including one redonning of the respirator, or the 
new protocol, which involves three exercises and two redonnings of the 
respirator. By providing regulatory flexibility to these employers, the 
proposal may reduce their costs in terms of decreasing fit testing 
time. In this regard, OSHA assumes that the proposed CNP REDON protocol 
would be adopted by some employers who use the existing CNP protocol, 
as well as some employers who are purchasing new or replacement 
equipment for administering fit tests; these employers would adopt the 
proposed protocol because it consists of fewer exercises than the 
existing CNP and ambient aerosol protocols, thereby decreasing the time 
and cost required for fit testing. However, the Agency believes that 
the proposed protocol is unlikely to be adopted by employers who 
currently use the ambient aerosol protocols because of the equipment 
and training investment they have already made to administer these 
protocols. Finally, the Agency proposes to include the screen tracing 
in the existing and proposed CNP fit testing protocols as a visual 
warning device to detect non-compliance with the breath hold procedure. 
OSHA concludes that this proposal would add no additional cost burden 
to employers because, as noted earlier, the manufacturer already 
provides this capability on the CNP test equipment. Therefore, the 
Agency preliminarily concludes that this proposed rulemaking would 
impose no additional costs on these employers. Consequently, the 
proposal requires no Preliminary Economic Analysis. Furthermore, 
because the proposal imposes no costs on employers, OSHA certifies that 
it would not have a significant impact on a substantial number of small 
businesses. Accordingly, the Agency need not prepare an Initial 
Regulatory Flexibility Analysis.

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 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 would 
remain the same whether employers currently use the other fit testing 
protocols already listed in Part I of Appendix A of the Respiratory 
Protection Standard, or implement the proposed fit testing protocol 
instead. Therefore, use of the proposed fit testing 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).
    Interested parties who wish to comment on OSHA's determination that 
the proposed fit testing protocol contains no additional paperwork 
requirements compared to the existing paperwork requirements must send 
their written comments to the Office of Information and Regulatory 
Affairs, Attn: OMB 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 their comments on this 
paperwork determination 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 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

[[Page 33892]]

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 proposal conforms to the preemption provisions of 
the OSH Act. Additionally, section 18 of the OSH Act prohibits states 
without approved plans from issuing citations for violations of OSHA 
standards; the Agency finds that the proposed rulemaking does not 
expand this limitation.
    OSHA has authority under Executive Order 13132 to propose adding 
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 proposal 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 proposal would provide employers in 
every state with an alternative means of complying with the fit testing 
requirements specified in paragraph (f) of OSHA's Respiratory 
Protection Standard.
    Should OSHA adopt the proposed fit testing protocol in a final 
rulemaking, section 18(c)(2) of the OSH Act (29 U.S.C. 667(c)(2)) 
requires State-plan States to adopt the same protocol, or develop an 
alternative that is at least as effective as that protocol. However, 
compliance with the new fit testing protocol would only provide 
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 them to adopt the final provisions to provide 
compliance options to employers in their states.

E. State Plans

    The Agency strongly encourages the 24 states and two territories 
with their own OSHA-approved occupational safety and health plans to 
revise their current Respiratory Protection Standard should the Agency 
adopt the proposed fit testing protocol based on this rulemaking. OSHA 
believes that such a revision would provide employers in the State-plan 
States with any 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 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, Virgin Islands, Washington, and Wyoming. 
Connecticut, New Jersey, and New York have OSHA-approved State Plans 
that apply to state and local government employees only.

F. Unfunded Mandates

    OSHA reviewed the proposal according to the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) and Executive Order 
12875. As discussed above in section IV.B (Preliminary Economic 
Analysis and Regulatory Flexibility Certification) of this preamble, 
the Agency has made a preliminary determination that the proposal 
imposes no additional costs on any private or public sector entity. The 
substantive content of the proposal applies only to employers whose 
employees use respirators for protection against airborne workplace 
contaminants, and compliance with the proposal would be strictly 
optional for these employers. Accordingly, the proposal would require 
no additional expenditures by either public or private employers.
    OSHA standards do not apply to state and local governments, except 
in states that have voluntarily elected to adopt a State Plan approved 
by the Agency. Consequently, the proposal 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 proposal 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 test 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 this CNP REDON proposal, except that the second 
respirator redonning is optional under the ANSI standard.\2\ However, 
paragraph 9.2 of the ANSI standard specifies that one optional exercise 
must be included with the required exercises.
---------------------------------------------------------------------------

    \2\ 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 fit testing protocol proposed in 
this rulemaking closely matches the requirements of the recent ANSI 
Z88.10-2001 standard. The proposed 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. In addition, the 
fit testing exercises in the proposed CNP REDON protocol are the same 
exercises in the ANSI standard when a second respirator redonning is 
selected as the optional exercise.

[[Page 33893]]

H. Review of the Proposed Standard by the Advisory Committee for 
Construction Safety and Health (ACCSH)

    This proposal would revise Part I.C of Appendix A of OSHA's current 
Respiratory Protection Standard (29 CFR 1910.134) by including the CNP 
REDON protocol with the three fit testing protocols already approved by 
the Agency, and would also make several technical revisions to the 
approved CNP protocol. Accordingly, this proposal would revise the fit 
testing requirements specified by the Respiratory Protection Standard 
for the construction industry (see 29 CFR 1926.103).
    OSHA's regulation governing the Advisory Committee on Construction 
Safety and Health (ACCSH) at 29 CFR 1912.3 requires the Agency to 
consult with the ACCSH whenever the Agency proposes a rulemaking that 
involves the occupational safety and health of construction employees. 
OSHA met with the ACCSH and described the CNP proposed rule at the 
ACCSH meeting on December 5, 2002. The ACCSH members had no questions 
or comments on this proposal at this meeting. Subsequently, OSHA 
distributed the proposed CNP rule to the ACCSH membership for their 
review prior to their next regular meeting on May 22, 2003. OSHA staff 
discussed the CNP proposal and answered questions from the ACCSH 
members during their meeting on May 22, 2003. The ACCSH then 
recommended that OSHA proceed with publishing the proposal.

I. Public Participation

    The Agency requests members of the public to submit written 
comments and other information concerning this proposal. These comments 
may include objections to the proposal, as well as comments that 
endorse or support the proposed amendment set forth in this notice. 
OSHA welcomes such comments and information so that the record of this 
rulemaking will represent a balanced public response on the issues 
involved. (See the sections above titled DATES and ADDRESSES for 
information on submitting these comments and information to the 
Agency.) Submissions received within the specified comment period will 
become part of the record, and will be available for public inspection 
and copying in the OSHA Docket Office.

J. List of Subjects in 29 CFR Part 1910

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

K. 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 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 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 May 28, 2003.
John L. Henshaw,
Assistant Secretary of Labor.

V. Proposed Amendment to Standard

    For the reasons stated 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 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.

    2. Appendix A to Sec.  1910.134 is amended as follows in Part I:
    A. In Section A, revise the introductory text of paragraph 14(a);
    B. In Section C, paragraph 4, 8th sentence, remove the name 
``Dynatech Nevada'' and add, in its place, ``Occupational Health 
Dynamics of Birmingham, Alabama.''
    C. In Section C, paragraphs 4(a)(2) and (5) are revised.
    D. In Section C, paragraph 4(c)(1) is revised.
    E. In Section C, paragraph 5 is added 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 shall 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 shall 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 shall ensure that the test 
exercises are performed in the appropriate test environment in the 
following manner:
* * * * *
    C. * * *
* * * * *
    (a) * * *
* * * * *
    (2) The CNP system default selected for test pressure shall be 
set at -15.0 mm (-0.58 inches) of water, and the modeled inspiratory 
flow rate shall be 53.8 liters per minute for performing fit tests.
* * * * *
    (5) The test subject shall be trained to hold his/her breath for 
at least 10 seconds.
* * * * *
    (c) * * *
    (1) The test instrument shall 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/her breath 
during the test. The test shall be terminated if the test subject 
fails to hold his/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 
shall 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), except they may 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 shall 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.

[[Page 33894]]



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

    (c) After completing the test exercises, the test administrator 
shall question each test subject regarding the comfort of the 
respirator. If the test subject states that the respirator is 
unacceptable, the employer shall ensure that the test administrator 
repeats the protocol using another respirator model.
    (d) When calculating the overall fit factor for each test 
subject, employers shall determine the harmonic mean of the fit 
factors measured for each test exercise.

[FR Doc. 03-13748 Filed 6-5-03; 8:45 am]
BILLING CODE 4510-26-P