[Federal Register Volume 74, Number 209 (Friday, October 30, 2009)]
[Proposed Rules]
[Pages 56141-56151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

RIN 0920-AA33


Total Inward Leakage Requirements for Respirators

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Centers for Disease Control and Prevention (``CDC'') 
proposes to establish total inward leakage (TIL) requirements for half-
mask air-purifying particulate respirators approved by the National 
Institute for Occupational Safety and Health (``NIOSH'') of CDC. The 
proposed new requirements specify TIL minimum performance requirements 
and testing to be conducted by NIOSH and respirator manufacturers to 
demonstrate that these respirators, when selected and used correctly, 
provide effective respiratory protection to intended users against 
toxic dusts, mists, fumes, fibers, and biological and infectious 
aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome 
(SARS) coronavirus, and Mycobacterium tuberculosis).

DATES: CDC invites comments on this proposed rule from interested 
parties. Comments must be received by December 29, 2009.

ADDRESSES: You may submit comments, identified by RIN: 0920-AA33, by 
any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: [email protected]. Include (HHS INSERT RIN 
NUMBER) and ``42 CFR part 84'' in the subject line of the message.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For detailed instructions on submitting comments and 
additional information on the rulemaking process, see the ``Public 
Participation'' heading of the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: William Newcomb, NIOSH National 
Personal Protective Technology Laboratory (``NPPTL''), Pittsburgh, PA, 
(412) 386-4034 (this is not a toll-free number). Information requests 
can also be submitted by e-mail to [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 56142]]

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this proposal.
    Comments submitted by e-mail or mail should be addressed to the 
``NIOSH Docket Officer,'' titled ``NIOSH Docket 137,'' and 
should identify the author(s), return address, and a phone number, in 
case clarification is needed. Comments can be submitted by e-mail to: 
[email protected]. E-mail comments can be provided as e-mail text or 
as a Word or Word Perfect file attachment. Printed comments can be sent 
to the NIOSH Docket Office at the address above. All communications 
received on or before the closing date for comments will be fully 
considered by CDC.
    All comments submitted will be available for examination in the 
rule docket (a publicly available repository of the documents 
associated with the rulemaking) both before and after the closing date 
for comments. A complete electronic docket containing all comments 
submitted will be available at: http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html and comments will be available in writing by 
request. NIOSH includes all comments received without change in the 
docket, including any personal information provided.

II. Background

A. Introduction

    Under 42 CFR part 84, ``Approval of Respiratory Protective 
Devices'' (``Part 84'') NIOSH approves respirators used by workers in 
mines and other workplaces for protection against hazardous 
atmospheres. The Mine Safety and Health Administration (``MSHA'') and 
the Occupational Safety and Health Administration (``OSHA'') require 
U.S. employers to supply NIOSH-approved respirators to their employees 
whenever the employer requires the use of respirators. In addition, 
MSHA co-approves with NIOSH all respirators used in mine emergencies 
and mine rescue.
    Testing, quality control, and other requirements under Part 84 are 
intended to ensure that respirators supplied to U.S. workers provide 
effective protection when properly employed within a complete 
respiratory protection program, as specified under MSHA and OSHA 
regulations. NIOSH requirements governing approval of the type of 
respirators covered by this proposed rule are specified in 42 CFR part 
84, principally under Subpart K--Non-Powered Air-Purifying Particulate 
Respirators. These were last updated in 1995 (60 FR 30336-30404). At 
that time, NIOSH proposed but ultimately omitted requirements for 
testing the performance of these respirators with respect to TIL \1\ to 
allow for further research on the effectiveness of TIL testing 
methods.\2\
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    \1\ TIL is the combination of contaminated air leaked through 
various potential sources including the facepiece-to-face seal, 
exhalation valves (if any), and gaskets (if any) and any 
contaminants that have penetrated the filter.
    \2\ The isoamyl acetate or American National Standards Institute 
(ANSI)/OSHA accepted fit tests.
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    The performance of the facepiece-to-face seal and other potential 
sources of leakage for this type of respirator are important because 
these determine how much unfiltered contaminated air the worker might 
inhale. The facepiece-to-face seal leakage can be substantial in the 
case of a poorly fitting respirator.
    Effective fit testing technology and procedures now exist to assure 
that respirators approved by NIOSH under Subpart K of Part 84 have 
adequately performing facepiece-to-face seals and sufficiently control 
TIL. The purpose of this rulemaking is to promulgate general 
requirements for such TIL testing and performance. The draft specific 
technical procedures to be applied under such requirements can be found 
at http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html. When 
finalized, the procedure will be detailed with all other NIOSH 
respirator certification testing procedures on the NIOSH Web page at 
http://www.cdc.gov/niosh/npptl/stps/respirator_testing.htm.

B. Background and Significance

    Employers rely upon NIOSH-approved respirators to protect their 
employees from airborne toxic contaminants and oxygen-deficient 
environments. More than 3.3 million private sector employees in the 
United States wear respirators for certain work tasks.
    Workers depend on respirators to protect them from asphyxiation or 
airborne contaminants that are known or suspected to cause acute and 
chronic health effects, such as heavy metal poisoning, acid burns, 
chronic obstructive pulmonary disease, silicosis, neurological 
disorders, and cancer.
    As the last line of protection for workers, respirators must be 
designed and manufactured to perform reliably and tested for compliance 
to a specified minimum level of performance. The worker might not be 
able to detect ineffective performance of the respirator prior to the 
toxic exposure, upon which it might be too late to avoid serious injury 
or death.
    Respirator manufacturers and NIOSH have critical roles in assuring 
employers, other purchasers of respirators, and workers that their 
respirators will provide the protection that is implied by their NIOSH 
certification. This rulemaking, which has been identified as a priority 
among the policymaking needs of the NIOSH respirator certification 
program by respirator manufacturers, employers, and other stakeholders 
of the program, is intended to strengthen this assurance.

C. Need for Rulemaking

    This rulemaking would establish TIL performance requirements and 
testing of half-mask, air-purifying particulate respirators currently 
approved under the requirements of Part 84 Subpart K--Non-Powered Air-
Purifying Particulate Respirators. These respirators are used by two 
million U.S. workers: For example, they are used in health care 
settings by caregivers and staff to patients with tuberculosis and 
other respiratory infections; in foundries, chemical manufacturing, and 
other production facilities with potentially hazardous aerosol 
exposures such as metals, coal, plastics, fibers, nano materials, and 
silica; and at construction and landscaping sites where workers are 
exposed to wood, silica, and other dusts from the grounds and building 
materials. These respirators are also stockpiled in large caches for 
deployment to public safety, health care, and other service personnel 
in the advent of an influenza pandemic.
    NIOSH evaluation of the TIL performance of these respirators would 
provide increased assurance to respirator purchasers and users that 
NIOSH-approved respirators can be expected to effectively protect the 
user against particulate contaminants, when properly donned and used. 
NIOSH has conducted benchmark testing of 101 respirator models 
currently on the market, using a testing regimen similar to that being 
proposed in this rulemaking, to assess their TIL performance. 
Approximately 30 percent of this class of respirators have facepiece 
seals that did not perform adequately to achieve a fit factor of 100 
(limiting total inward leakage to no more than 1 percent), as specified 
by OSHA,\3\ for substantial numbers of the human subjects donning them 
for

[[Page 56143]]

benchmark testing. This finding is supported by published 
research.4 5
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    \3\ See 29 CFR 1910.134 (f)(7).
    \4\ Coffey C, Lawrence R, Campbell D, Zhuang Z, Calvert C, 
Jensen P. Fitting Characteristics of Eighteen N95 Filtering 
Facepiece Respirators. JOEH. 2004;1: 262-271.
    \5\ Lawrence R, Duling M, Calvert C, and Coffey C. Comparison of 
Performance of Three Different Types of Respiratory Protection 
Devices. JOEH. 2006;3:465-474.
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    There are three implications of this finding from benchmark 
testing, which define the need for this rulemaking. One, when an 
employer purchases one of these respirator models with poor TIL 
performance for use within a complete respirator program, as specified 
by OSHA and MSHA, fit-testing of the employees should reveal that a 
substantial proportion of the employees do not achieve an adequate fit. 
This presumably compels the employer to purchase other respirators and 
conduct additional fit-testing on employees, continuing such purchases 
and fit testing until respirators are identified, through trial and 
error, that provide all employees with adequately fitting respirators.
    This process of identifying respirators that provide an adequate 
fit to each employee would be streamlined through NIOSH evaluation of 
TIL performance as proposed in this rulemaking, using panels of test 
subjects representative of intended users of a particular respirator 
model and size. The employee is more likely to achieve a good fit from 
a respirator make that has been demonstrated through testing to achieve 
a specified minimum level of performance in this respect.
    The second implication applies to situations in which these poorly 
performing respirators are being used by employees and other 
individuals without the benefit of a complete respirator program that 
includes fit testing. A recent NIOSH/Bureau of Labor Statistics (BLS) 
survey of respirator use among U.S. workers found that 40 percent of 
employers are not selecting respirators for their employees based on 
fit testing.\6\ Self-employed workers in industries such as 
construction may be even less likely to perform fit testing.
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    \6\ NIOSH/BLS [2003]. Respirator usage in private sector firms, 
2001 (PDF only 1,118 KB (278 pages)). Cincinnati, OH: U.S. 
Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health.
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    For these employee and worker populations, the poor fit might not 
be recognized, increasing the likelihood that substantial numbers of 
these respirator users are not being adequately protected from their 
hazardous exposures. While the only way to ensure that a particular 
respirator make and size performs adequately for a user is through fit 
testing of that user, NIOSH testing and evaluation of TIL performance 
would increase the likelihood that these workers who lack fit testing 
will be protected, by obtaining respirators that are demonstrated to 
generally provide a good fit to intended users when worn properly.
    The third implication applies to the stockpiling of respirators for 
use in case of an influenza pandemic. During a disease outbreak, such 
respirators might be deployed without a respirator program and without 
fit testing. Currently, the selection of NIOSH approved respirators 
provides no assurance that stockpiled respirators are likely to provide 
adequate protection to the health care, public safety, and other 
personnel who might use them without a respirator program and fit 
testing. The availability of NIOSH certification with respect to TIL 
performance would increase the likelihood that such users would obtain 
an adequate fit and protection, even though it could not provide the 
same level of assurance as is obtained from fit testing of each 
individual for the selection of respirators.
    In summary, revising Part 84 to incorporate minimum performance 
requirements governing TIL is a necessary step to ensure that NIOSH-
approved half-mask air purifying particulate respirators have 
facepiece-to-face and other seals that perform adequately to provide 
effective protection to most intended users. While this certification 
testing will not substitute for individual fit testing, respirator 
training, and other components of a complete respiratory protection 
program critical to worker protection, it will substantially improve 
the current circumstances by approving only respirators that 
demonstrate the ability to meet minimum specified performance 
requirements and are likely to provide adequate protection to most 
intended users when properly fitted and worn.

D. Public Meetings for Discussion and for Comment

    NIOSH held public meetings to discuss underlying issues and 
technical matters addressed in this proposed rule on August 25, 2004, 
at the Key Bridge Marriott, Arlington, VA, and June 26, 2007, at The 
Embassy Suites Pittsburgh International Airport, Coraopolis, 
Pennsylvania.\7\ Official transcripts of the meetings, as well as 
public comments submitted subsequently, are available in Docket 
36 from the NIOSH Docket Office at the address provided above.
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    \7\ Notice of these meetings was published in the Federal 
Register (FR69:133:42059) (FR72:102:29501-29502). NIOSH also sent a 
letter announcing the meetings to known stakeholders and posted it 
on the NIOSH Web page http://www.cdc.gov/niosh/npptl.
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    One issue of concern raised in response to NIOSH presentations was 
that the NIOSH rule would prevent respirator manufacturers from 
producing models targeted to specific demographic subpopulations, such 
as women, for example. The current proposal would not impose any such 
limitation. NIOSH will construct test subject panels for the 
certification testing that represent the population targeted by the 
manufacturer, as described in the manufacturer's user instructions.
    Another concern raised by commenters is that this rulemaking would 
shift responsibility for the fit achieved by employees from the 
employer, who is required to conduct fit testing under OSHA and MSHA 
regulations, to the respirator manufacturer. No such substitution is 
intended or effected by the rulemaking. As discussed above, NIOSH would 
require that manufacturers produce respirators that have effective face 
seals, such that they can be expected generally to fit intended users 
and control TIL adequately when the respirators are properly fit 
tested, donned, and used. This general assurance does not replace 
individual fit testing to be conducted by employers, which ensures that 
each individual employee obtains an effective fit, as required by OSHA 
and MSHA.
    NIOSH already requires adequate TIL performance for other types of 
respirators under Part 84. NIOSH omitted such requirements for the 
category of respirator covered in this rulemaking only because of 
testing limitations that existed in 1995 when Part 84 was established.
    NIOSH received concerns regarding the use of various testing 
technology and methods to evaluate TIL. The technology is identical to 
that in common use for measuring respirator fit and is accepted by 
OSHA.\8\
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    \8\ 29 CFR 1910.134, Appendix A, Part I, C, 3.
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    Comments were received questioning the representativeness of the 
test panel with respect to the population of respirator users. The test 
panel was developed by NIOSH to replace a panel developed decades ago 
by Los Alamos National Laboratory using military personnel. The new 
panel has been the subject of publications and multiple reviews, 
including a review by the

[[Page 56144]]

Institute of Medicine.9 10 11 It is documented in testing 
and agreed by reviewers that the proposed panel represents a 
substantial improvement over its predecessor panel and should be 
implemented.
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    \9\ Zhuang Z, Bradtmiller B, and Shaffer R.E. New Respirator Fit 
Test Panels Representing the Current U.S. Civilian Workforce. 
Journal of Occupational and Environmental Hygiene 2007;4: 647-659.
    \10\ Zhuang Z, Groce D, Ahlers H, Iskander W, Landsittle D, 
Guffey S, Benson S, Viscusi D, Shaffer R. Correlation between 
Respirator Fit and Respirator Fit Test Panel Cells by Respirator 
Size. Journal of Occupational and Environmental Hygiene. 2008;5: 
617-628.
    \11\ Institute of Medicine. Assessment of the NIOSH Head-and-
Face Anthropometric Survey of U.S. Respirator Users. The National 
Academies Press, Washington, DC (2007).
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    Commenters also questioned the number of test subjects and the 
pass/fail criteria. NIOSH has changed the pass/fail criteria and the 
number of test subjects as a result of these comments. A full technical 
discussion of the statistical basis for the proposed standards 
described below is provided in a paper titled ``Statistical Basis for 
TIL Testing'' in the NIOSH Docket for this rulemaking posted at: http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html. The maximum allowable 
leakage is now equivalent to the fit test criteria required by OSHA for 
this type of respirator.\12\
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    \12\ 29 CFR 1910.134(f)(7).
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    These concerns have been given consideration in the design of this 
proposed rule and will be considered further in the development of 
testing procedures to be implemented under a final rule. NIOSH 
encourages interested parties to submit any technical concerns along 
these lines, as well as policy concerns, in response to this proposed 
rule.
    NIOSH will convene a public meeting to provide stakeholders an 
opportunity to comment orally on this rulemaking during the comment 
period. The meeting will be in the vicinity of Washington DC and will 
be announced in a separate notice in the Federal Register. This meeting 
will also be available through remote access capabilities. Participants 
will be able to simultaneously listen and view presentations over the 
Internet, as well as comment.

III. Summary of Proposed Rule

    This proposed rule would establish new TIL requirements for half-
mask air-purifying particulate respirators approved by NIOSH, or NIOSH 
and MSHA, under 42 CFR part 84--Approval of Respiratory Protective 
Devices. These provisions would be added to Subpart K. The following is 
a section-by-section summary which describes and explains the 
provisions of the rule. The public is invited to provide comment on any 
aspect of the proposed rule. The complete regulatory text for this 
proposed rule is provided in the last section of this notice. For the 
convenience of readers, the regulatory text presents the amended 
sections in their entirety, including the proposed new and revised 
paragraphs and those that would remain unrevised under the amended 
sections.

Subpart K

Section 84.175 Half-Mask Facepieces, Full Facepieces, Hoods, Helmets, 
and Mouthpieces; Fit and Total Inward Leakage (TIL); Minimum 
Requirements

    This section includes a variety of general requirements governing 
the fit and functionality of the various designs of non-powered air-
purifying particulate respirators. NIOSH proposes to amend this section 
to incorporate TIL standards and a general specification of testing 
requirements. Paragraphs in this section that are not discussed below 
are current provisions that NIOSH is not proposing to amend.
A. Half-Mask Respirators Designed for Specific Segments of the 
Population
    Paragraph (a)(3) is new. It would allow applicants to seek approval 
for half-mask respirators designed to fit a specific segment of the 
population, such as ``women'' or persons within specific dimensional 
limits. Currently, respirators must be designed to fit the population 
broadly, either by providing one size that fits diverse facial shapes 
and sizes or by providing multiple sizes. It is advantageous to 
employers and other respirator purchasers to supply a respirator that 
fits the population broadly because it simplifies their selection and 
purchasing of such equipment. It also increases the likelihood that the 
majority of workers and other respirator users will obtain respirators 
that fit. However, in connection with public discussions regarding the 
concepts underlying TIL standards and testing, several respirator 
manufacturers have advocated that they have the option of producing 
respirators designed to fit particular subpopulations, presumably to 
more reliably achieve a fit for certain face shapes that might not 
obtain a good fit from generally-targeted designs. Furthermore, while 
NIOSH benchmark testing and other research have indicated that many 
respirators do not actually provide a good fit to substantial segments 
of the population, it is possible that some of these respirators are 
well designed to fit particular subpopulations.
    NIOSH accepts the proposition that in some cases it might be 
effective to design respirators to fit specific subpopulations that 
share common facial characteristics, resulting in better TIL 
performance. Since this approach would rely on purchasers recognizing 
an appropriate match, NIOSH has specified that the membership of the 
subpopulation, as described, must be somehow identified. Thus, for 
example, sex is clear. However, it is unclear to NIOSH whether there 
are other demographic classifications or descriptors for subpopulations 
that could be both reliably interpreted by users and reliably 
determinative in terms of respirator fit. Users must be provided 
sufficient information to permit them to self-identify. They might not 
effectively self-identify to match a manufacturer's intentions if 
provided only vague general descriptions of intended facial shapes or 
characteristics.
    A new paragraph (g) would require that any part of a respirator 
that would have to be removed to conduct a user seal check must be 
replaceable without disturbing the fit of the respirator. This is a 
current requirement for other types of respirators and is essential to 
assuring the validity of the seal check.
    Paragraph (h) is also new. It would require the user instructions 
of a half-mask respirator to specify the intended users of the 
respirator, by facial size, if applicable, and by other descriptive 
information as might be necessary for respirators designed for specific 
subpopulations, as explained above. This information would be relied 
upon by purchasers and users and by NIOSH in conducting TIL testing, as 
discussed below.
B. Half-Mask Respirator TIL Testing Requirements
General Discussion
    Subsection (i) is new. It proposes the general procedures, 
requirements, and performance standards for TIL of non-powered half-
mask air-purifying particulate respirators. The standards have been 
designed statistically to identify and pass with high accuracy (greater 
than 90 percent probability) those respirators that provide adequate 
TIL performance to the large majority of intended users (in the range 
of 80 to 90 percent of intended users) while failing with near 
certainty (greater than 99 percent probability) those respirators that 
do not provide adequate TIL performance to a majority (50 percent or 
more) of intended users. Adequate TIL performance is a TIL value of 
1.0,

[[Page 56145]]

equivalent to a fit factor of 100, which is the level of performance 
for these respirators specified by OSHA.\13\ The number of test 
subjects proposed for the testing has been limited to maintain 
reasonably modest testing costs for NIOSH and respirator manufacturers 
while achieving a representative cross-section of the intended user 
population and providing sufficient ``statistical power'' to evaluate 
TIL performance accurately. A full technical discussion of the 
statistical basis for the proposed standards described below is 
provided in a paper titled ``Statistical Basis for TIL Testing'' in the 
NIOSH Docket for this rulemaking posted at: http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html. NIOSH requests public comment concerning 
the judgments inherent to these proposed standards, as well as comment 
on the supporting statistical analysis referenced here.
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    \13\ See 29 CFR 1910.134(f)(7).
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    NIOSH invites public comment on the proposed standards specified in 
this subsection. There are several critical factors that the public 
should consider in providing such comments:
    1. What percentage of the intended user population should be able 
to achieve adequate TIL performance for the respirator to be approved 
by NIOSH? NIOSH has proposed that 75 percent or higher should be able 
to achieve such performance. This performance level is based on the 
design and statistical considerations presented above in this General 
Discussion section; essentially, using this 75 percent testing 
parameter would provide strong assurance (90 percent probability) that 
testing identifies for approval respirators fitting the large 
majority--80 to 90 percent--of intended users, while rejecting with 
near certainty (99 percent probability) respirators that fit only a 
minority--less than 50 percent--of intended users.
    2. As the percentage of the intended user population capable of 
achieving adequate TIL performance from a respirator declines, at what 
point, if any, should NIOSH set the limit to be nearly certain (e.g., 
99 percent or higher probability) that the respirator would not be 
approved? NIOSH has proposed that a respirator should be rejected with 
near certainty if it does not provide adequate TIL performance to at 
least a majority (50 percent or greater) of intended users. NIOSH 
believes this is a reasonable standard for defining the performance of 
a poorly fitting respirator that should not be approved.
    3. How many test subjects should be included in the testing, 
considering the fact that testing accuracy increases with the number of 
test subjects, but that the cost of testing also increases with the 
number of test subjects? Do the numbers of subjects proposed by NIOSH 
(15 to 35 test subjects, as specified under Sec.  84.175(i)(4)) reflect 
an appropriate balance between limiting manufacturer testing costs and 
providing sufficiently accurate results? What level of testing cost is 
supportable, in the view of manufacturers? Would manufacturers prefer a 
higher numbers of test subjects and associated higher costs, to reduce 
further the likelihood that a respirator with adequate TIL performance 
is denied by chance?
Discussion of Specific Provisions
    Paragraph (i)(1) specifies that NIOSH will apply solely the user 
instruction information describing the intended users of a respirator 
to select an appropriate panel of TIL test subjects. Thus, NIOSH will 
be interpreting the user instructions with the same limitations as a 
purchaser or intended user.
    This provision would have no practical effect in the case of a 
respirator designed to fit the general population, either through one 
size that fits all users or a comprehensive set of differing sizes. In 
such a case, the respirator would be tested against the NIOSH testing 
panel, which respirator manufacturers can replicate in their pre-
application TIL testing to ensure that their respirator is designed and 
manufactured to achieve an adequate fit on the testing panel to meet 
the NIOSH TIL standard. On the other hand, this provision limiting 
NIOSH to the information provided in the user instructions could be 
important in the case of a respirator designed for use by a specific 
subpopulation. As a consequence, if the applicant were to have selected 
test subjects for pre-application TIL testing using additional criteria 
or distinguishing factors not specified in the user instructions, it is 
possible the applicant would obtain a panel of test subjects 
substantially different from that selected by NIOSH for its TIL 
testing. A substantial difference in test panels could produce 
different testing results and potentially result in the failure of the 
respirator to pass the TIL performance standard.
    Paragraph (i)(1) also specifies the number or minimum number of 
representative test subjects to be used in TIL testing; 35 for a 
respirator intended to fit the general population and a minimum of 15 
for a respirator intended to fit one or more specific subpopulations. 
These numbers are proposed in combination with the performance 
standards specified in paragraph (i)(4) to provide a sufficiently 
accurate measure of a respirator's TIL performance for at least 75 
percent of intended users while minimizing the chance of either 
approving a respirator that did not achieve adequate TIL performance 
for at least 50 percent of intended users or of disapproving a 
respirator that only by chance failed to achieve the TIL performance 
standard for at least 75 percent of intended users. A full technical 
discussion of the statistical bases of these standards is provided in a 
paper titled ``Statistical Basis for TIL Testing'' posted at: http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html.
    Paragraph (i)(2) specifies that test subjects will conduct a user 
seal check or other donning procedure prior to each test. This is 
appropriate practice for a worker donning this type of respirator, to 
ensure that it is positioned correctly on the face to provide an 
optimal facepiece-to-face seal.
    Paragraph (i)(3) specifies that the TIL test will be administered 
to each test subject up to three times, terminating testing either when 
a test has produced a TIL value of 1.0 percent or less or after the 
third test, whichever occurs first. The TIL value of 1.0 percent is 
equivalent to a fit factor of 100, which is the minimum acceptable fit 
factor for half-mask respirators specified by OSHA under 29 CFR 
1910.134 (f)(7). The limit of administering the test up to three times 
to achieve this performance standard is integral to the statistical 
basis establishing the accuracy of the TIL testing, as discussed above 
and in technical detail in the paper ``Statistical Basis for TIL 
Testing'' posted at: http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html.
    Paragraph (i)(4) provides the TIL performance standards for 
approval of these respirators, differing under clauses (i) and (ii) to 
account for the lower minimum number of test subjects (a minimum of 15 
versus 35) that would be used to test a respirator intended to fit one 
or more specific subpopulations under clause (ii). Given the lower 
number of test subjects, a higher proportion of the test subjects (80 
percent versus approximately 75%) would be required to achieve a TIL 
value of 1.0 percent or less for the respirator to be approved. This 
difference is statistically based in the decreasing reliability of an 
individual test as the total number of test subjects declines. It is 
discussed and illustrated in the paper ``Statistical Basis for TIL 
Testing'' posted at: http://www.cdc.gov/niosh/docket/NIOSHdocket0137.html. The proposed use of a minimum of 15 test subjects 
for respirators intended to

[[Page 56146]]

fit one or more subpopulations of users allows for the use of a larger 
number of test subjects for subpopulations that are more diverse and 
hence, require a more diverse panel of test subjects to provide 
sufficiently comprehensive representation of facial dimensions.
    Paragraph (i)(5) specifies that the probe would be located halfway 
between the wearer's nose and mouth for TIL testing of the respirator. 
This specification is consistent with the technology used for such 
testing and is necessary to ensure a reproducible determination of TIL.
    Paragraph (i)(6) specifies the use of sodium chloride (table salt) 
as the challenge aerosol for TIL testing and specifies a particle size 
range of 0.02 to 0.06 micrometers within a concentration range of 1,500 
to 3,000 particles/cm\3\. Sodium chloride is used because it is safe 
for the test subjects and has appropriate physical properties for the 
test. The particle size range represents the most penetrating particle 
sizes, producing an atmosphere that challenges the limits of the 
respirator's TIL performance. The concentration range allows for 
accurate measurement using the current technology available for TIL 
testing.
    Paragraph (i)(7) specifies the sequence of exercises that comprise 
the TIL test. These are the standard, OSHA-required set of exercises to 
be used in fit-testing these respirators. They provide for realistic 
respirator use conditions that challenge the respirator's TIL 
performance through typical work movements, postures, grimaces that can 
disturb the facepiece-to-face seal, talking, and deep breathing to 
increase the negative pressure inside the facepiece.
    Paragraph (i)(8) specifies that the test exercises will be 
performed using the OSHA protocol provisions specified at 29 CFR 
1910.134 Appendix A, Part I.A.14(b). This protocol paragraph specifies 
the duration of each test exercise used in fit testing. Currently, OSHA 
requires each exercise be performed for one minute except for the 
grimace, which is performed for 15 seconds. By specifying this element 
of the OSHA protocol, NIOSH would ensure that NIOSH TIL testing remains 
consistent with OSHA fit testing requirements in this regard.
    Paragraph (i)(9) specifies that the test subject will not adjust 
the facepiece position once the TIL test exercises begin, and that any 
such adjustment would void the test, requiring that it be repeated. 
This is current fit-testing practice and is required by OSHA under 29 
CFR 1910.134 Appendix A, Part I.A.14(b). The intent of this requirement 
is to realistically reflect the practices and conditions of workers 
when wearing respirators. A worker typically would adjust the facepiece 
if he sensed a poor facepiece-to-face seal. However, a worker might not 
adjust the facepiece for many reasons, such as not sensing a poor 
facepiece-to-face seal, or being engaged in a task that occupies both 
hands. Moreover, the need to adjust the facepiece periodically after 
donning the respirator indicates an undesirable TIL performance 
characteristic. For example, the need to make such adjustments during a 
work task would constitute a hazard if safe work practice requires that 
the worker's hands and/or attention be fully engaged in the work task.
    Paragraph (i)(10) specifies how TIL is determined. TIL results are 
expressed as the percentage quantity of the ambient concentration of 
sodium chloride measured inside the respirator. For example, if the 
ambient concentration were 1000 particles/cm\3\ and the respirator 
reduced this concentration to 10 particles/cm\3\, then the TIL would be 
expressed as 1.0 percent, because the concentration inside the 
respirator facepiece was reduced to 1.0 percent of the ambient level. 
This is equivalent to a fit factor of 100, which is the inverse of the 
TIL and is calculated as the ratio of the ambient concentration over 
the concentration inside the respirator facepiece.
    Paragraph (i)(11) specifies design and performance attributes of 
the instrumentation to be used to take measurements of TIL. These 
include the use of a condensation nuclei counter, the ability to 
measure sodium chloride challenge aerosol in the specified size range 
of 0.02 to 0.06 micrometers, and during measurement, responding 
linearly to changes in the aerosol concentration, within plus or minus 
five percent, over the ambient concentration range of 70 to 3,000 
particles/cm\3\ and TIL <= 5.0 percent. These attributes are sufficient 
to meet the needs of TIL testing as proposed and to ensure that NIOSH 
and manufacturers use equivalent instrumentation.

Section 84.205 Facepiece Test; Minimum Requirements

    This section specifies facepiece test requirements for chemical 
cartridge respirators. Some of these respirators are designed as half-
mask, combination chemical cartridge/particulate filtering (i.e., air-
purifying) respirators. For such combination respirators, NIOSH 
proposes applying the identical TIL test requirements as proposed under 
Sec.  84.175 in this rulemaking for all half-mask air-purifying 
particulate respirators. These TIL test requirements would be in 
addition to the current facepiece test requirements already covered 
under this section for chemical cartridge respirators. Paragraphs in 
this section that are not discussed below are current provisions that 
NIOSH is not proposing to amend.
A. Non-Germane Technical Revisions to General Provisions of Sec.  
84.205
    Paragraphs (c) and (d) would be revised, substituting the term 
``user seal check'' for ``fit test'' to be consistent with current 
terminology in use.
    Paragraph (d)(1) would be revised to reduce the specified ambient 
concentration of isoamyl acetate vapor in the testing chamber from 
1,000 to 500 parts per million (ppm) for testing full facepieces, 
mouthpieces, hoods, and helmets. This represents current practice, 
which the NIOSH respirator certification program instituted when NIOSH 
lowered the IDLH (Immediately Dangerous to Life or Health 
concentration) for isoamyl acetate to 1,000 ppm.
B. Coverage of Combination Half-Mask Chemical Cartridge/Particulate 
Filtering Respirators by TIL Testing Requirements of Sec.  84.175
    A new paragraph (e) would be added to require TIL testing under the 
proposed provisions of Sec.  84.175(i) for all combination half-mask 
chemical cartridge/particulate filtering respirators. The NIOSH 
respirator certification program currently conducts qualitative testing 
using isoamyl acetate vapor to evaluate the fit of chemical cartridge 
respirators under Sec.  84.205, including these combination 
respirators. The proposed TIL testing would ensure that the particulate 
filtering protective capacity of these combination respirators is as 
effective as the single-purpose air-purifying respirators addressed by 
this rulemaking.

IV. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether a regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the executive order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in a rule (1) Having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity,

[[Page 56147]]

competition, jobs, the environment, public health or safety, or state, 
local, or tribal governments or communities (also referred to as 
``economically significant''); (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising novel legal or policy issues arising 
out of legal mandates, the President's priorities, or the principles 
set forth in this executive order.
    This proposed rule is not considered economically significant, as 
defined in section 3(f)(1) of the executive order. However, this 
proposed rule is a ``significant regulatory action'' within the meaning 
of the executive order and has been reviewed by OMB.
    For the leading U.S. respirator manufacturers who obtain approvals 
from NIOSH, likely to represent a majority share of the current market 
supply of NIOSH-approved products covered by this rulemaking, NIOSH 
benchmark testing indicates that the new TIL requirements can be met by 
current products without additional development or manufacturing costs. 
For those manufacturers whose products do not meet the proposed TIL 
testing standards, NIOSH has estimated design and retooling costs 
ranging from $55,000 to $200,000 per model or models of respirator with 
a unique facepiece, depending on the unit volume of production, the 
type of facepiece seal, and the degree of automation of the 
manufacturing operation. NIOSH invites comment from manufacturers on 
these estimates, all of which are based on expert opinion.
    It is not possible to estimate the number of current approval 
holders whose products would not meet the proposed TIL requirements and 
who would redesign their products to seek new NIOSH approvals, 
incurring design and retooling costs. However, to the extent that some 
manufacturers may decide not to redesign products and seek new 
approvals, the proposed implementation schedule for the new 
requirements (see Section IV.J of this preamble) would provide other 
manufacturers sufficient time to increase production capacity and 
replace products exiting the NIOSH-approved respirator market. NIOSH 
invites comment from approval holders on their intent to seek new 
approvals under the proposed requirements.
    All manufacturers intending to continue to hold NIOSH approvals for 
respirators covered by this rulemaking would incur additional costs for 
TIL testing. NIOSH estimates these costs would range from $8,500 to 
$12,000 per respirator approval, which would cover a respirator 
produced in multiple sizes and may also cover multiple respirator 
models employing the same respirator facepiece. The testing costs would 
vary based on the number of test subjects required. NIOSH anticipates 
applications for up to 500 approvals during the first two years of 
implementation of TIL requirements, when NIOSH expects the majority of 
requests for approval would be received. NIOSH estimates total testing 
and certification costs to manufacturers of up to $3.1 million annually 
for these two initial implementation years.\14\ NIOSH anticipates TIL 
testing associated with routine submissions for new product approvals 
in subsequent years will be required for less than 15 percent of the 
NIOSH-approved product market annually, for estimated costs of $825,000 
annually.\15\
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    \14\ This estimate assumes testing and certification of 250 
units annually for two years at an average annual cost of $11,000 
per unit for a panel of test subjects and $1,250 in other 
certification costs. About 30 percent of these other certification 
costs will be borne by the manufacturers irrespective of this 
proposed rulemaking as a result these products having a typical 
product life cycle of 5 to 10 years (see note 10 below).
    \15\ The product life cycle of these respirators is typically 5 
to 10 years; meaning between 10 and 20 percent of 500 NIOSH-
certified respirators could be expected to be redesigned annually on 
average. However, product redesigns would not necessarily involve 
redesign of the facepiece in such a way that would require TIL 
retesting.
---------------------------------------------------------------------------

    NIOSH does not anticipate additional costs to consumers (e.g., 
employers, self-employed workers) as a result of the proposed TIL 
requirements. The current NIOSH-approved products that NIOSH expects to 
pass the proposed requirements do not differ substantially in price 
from comparable products that are not expected to pass without 
modification.
    NIOSH anticipates the TIL requirements will also result in 
substantial benefits, although NIOSH lacks information to estimate them 
quantitatively. Of greatest importance, substantial numbers of workers 
are more likely to derive the expected respiratory protection from 
hazardous particulate exposures as a result of using respirators with 
adequate TIL performance. As discussed in Section II.C. of this 
preamble, NIOSH benchmark testing and other research indicate that many 
respirators covered by this rulemaking do not perform well in 
preventing substantial inward leakage when tested against diverse 
facial types and sizes. Over 50 percent of workers and other respirator 
users do not have the benefit of individual fit testing, let alone a 
complete respiratory protection program. This suggests that substantial 
numbers of workers may receive improved protection as a result of 
instituting TIL testing for the certification of these respirators, 
increasing the likelihood that a worker without fit-testing or training 
might obtain adequate TIL performance. Such improved protection will 
result in reduced work-related disease and disability among the 
workforce, including such conditions as work-related silicosis, chronic 
obstructive pulmonary disease (COPD), asthma, and cancer, and 
biological and infectious diseases such as avian influenza, SARS,\16\ 
and tuberculosis.17 18 Work-related COPD and asthma alone 
are estimated to cost $6.6 billion annually.\19\ The costs of this 
rulemaking would be covered by the prevention of a small fraction of a 
percent of the occupational disease burden associated with workplace 
respiratory hazards.
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    \16\ Eninger R, Honda T, Adhikari A, Heinonen-Tanski H, Reponen 
T, and Grinshpun S. Filter Performance of N99 and N95 Facepiece 
Respirators Against Viruses and Ultrafine Particles. Ann. Occup. 
Hyg. 2008;52(5):385-396.
    \17\ Willeke K, Qian Y, Donnelly J, Grinshpun S, Ulevicius V. 
Penetration of Airborne Microorganisms Through a Surgical Mask and a 
Dust/Mist Respirator. American Industrial Hygiene Association 
Journal. 1996;57(4):348-355.
    \18\ Qian Y, Willeke K, Grinshpun S, Donnelly J and Coffey C. 
Performance of N95 Respirators: Filtration Efficiency for Airborne 
Microbial and Inert Particles. American Industrial Hygiene 
Association Journal. 1998;59(2):128-132.
    \19\ Leigh JP, Romano P, Schenker MB, and Kreiss K. Costs of 
Occupational COPD and Asthma. Chest. 2002;121:264-272.
---------------------------------------------------------------------------

    In addition, as discussed in Section II.C. of this preamble, 
respirators that do not perform adequately in TIL testing would be 
expected to fail fit testing for employees among employers who conduct 
fit testing as required by OSHA. This is presumably causing the 
employers to purchase additional respirator models until all employees 
have respirators that fit adequately, incurring costs for the non-
fitting respirators, for repeated respirator fit testing, and for lost 
employee work time consumed by the repetitive fit testing. NIOSH 
invites comments from employers regarding the current extent of such 
costs.
    In summary, while NIOSH cannot estimate the total costs associated 
with this rulemaking, available information indicates these costs are 
modest and also suggests that they are likely to be considerably 
outweighed by economic benefits reaped by improved worker protection 
and the promotion of increased efficiency among employer respiratory 
protection programs.

[[Page 56148]]

Through this rulemaking, NIOSH is inviting public comment from 
respirator manufacturers, employers, and others to provide greater 
specificity for NIOSH estimates of economic costs and benefits 
anticipated in association with the implementation of the proposed TIL 
requirements.
    The proposed rule would not interfere with state, local, and tribal 
governments in the exercise of their governmental functions.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities, including small businesses, small 
governmental units, and small not-for-profit organizations. The 
Department of Health and Human Services (``HHS'') certifies that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities within the meaning of the RFA.
    The majority of respirator manufacturers producing half-mask air-
purifying particulate respirators approved by NIOSH and covered by this 
rule are small businesses as defined under the Small Business Act (Pub. 
L. 85-536) for this industry sector (NAICS 339112--Medical Instruments 
and Equipment Manufacturers), employing fewer than 500 employees. For 
these manufacturers, the proposed rule would establish new TIL 
requirements applicable to respirators approved by NIOSH for use in 
potentially hazardous work atmospheres involving toxic, obstructive, 
and carcinogenic dusts, nanoparticles, and biological and potentially 
infectious aerosols. Workers don these respirators for protection in a 
wide variety of industrial sectors, such as mining, manufacturing, 
construction, and agriculture, and service sectors, such as health 
care, where medical, nursing, and custodial staff are exposed to 
biological and potentially infectious aerosols. These respirators are 
also being stockpiled and would be employed extensively by health care, 
public health, safety, and other first responders who would be engaged 
in the case of a pandemic influenza outbreak.
    This rulemaking will result in additional costs for TIL testing and 
certification by NIOSH, for all respirator manufacturers intending to 
continue to hold NIOSH approvals for respirators covered by this 
rulemaking. As explained in Section IV.A of this preamble, NIOSH 
estimates the testing costs would range from $8,500 to $12,000 per 
respirator approval, which would include a respirator produced in 
multiple sizes and may also cover multiple respirator models employing 
the same respirator facepiece. The cost would vary depending on the 
number of test subjects required. NIOSH anticipates applications for up 
to 500 approvals during the first 2 years of implementation of TIL 
requirements, when the majority of requests for approval would be 
received. NIOSH estimates total testing and certification-related costs 
to manufacturers of $3.1 million annually for these 2 implementation 
years. NIOSH anticipates TIL testing associated with routine 
submissions for new product approvals in subsequent years will be 
required for less than 15 percent of the NIOSH-approved product market 
annually, for estimated costs of $825,000 annually.
    These total testing and certification costs, from the initial 2-
year implementation period, when annualized over an average 7.5-year 
product life-cycle, amount to less than $1.01 million annually. This is 
a small fraction of one percent of the annual revenues of respirator 
manufacturers, which totaled $1.7 billion in 2001 for all products and 
have grown extensively since.\20\ Although respirator manufacturers 
produce a wide range of products beyond those covered by this 
rulemaking, half-mask air-purifying particulate respirators, including 
chemical gas mask/filtering respirators, represent the highest volume 
respirator sales and comprise a large component of total revenues.
---------------------------------------------------------------------------

    \20\ Frost and Sullivan Research Service; http://www.frost.com/prod/servlet/report-brochure published 30 March 2005.
---------------------------------------------------------------------------

    After implementation, the routine annualized costs to manufacturers 
resulting from TIL testing associated with the redesign of products 
would be less than $141,000.\21\
---------------------------------------------------------------------------

    \21\ This assumes new products would be introduced for 15 
percent of the product market annually, resulting in $865,000 of 
annual TIL testing costs. These are annualized over a 7.5 year 
period (the average life-cycle of these products.
---------------------------------------------------------------------------

    As discussed in Section IV.A of this preamble, this rulemaking is 
not anticipated to result in any additional costs to small employers or 
self-employed workers and may result in lower costs. Based on NIOSH 
benchmark testing, respirators likely to represent a majority share of 
the current market supply are expected to pass the proposed TIL 
standards without modification, and these respirators are priced 
comparably to respirators that are not expected to pass as currently 
designed. Furthermore, the costs incurred by employers and by self-
employed workers in selecting adequately fitting respirators through 
trial-and-error processes should be reduced as the implementation of 
this proposed rule curtails the supply of NIOSH-approved respirators 
with poor TIL performance.
    NIOSH invites the public to provide more specific and current 
revenue data on the respirator market covered by this rulemaking.
    For the reasons provided, a regulatory flexibility analysis, as 
provided for under RFA, is not required.
C. What Are the Paperwork and Other Information Collection Requirements 
(Subject to the Paperwork Reduction Act) Imposed Under This Rule?
    The Paperwork Reduction Act is applicable to the data collection 
aspects of this rule. Under the Paperwork Reduction Act of 1995, a 
federal agency shall not conduct or sponsor a collection of information 
from ten or more persons other than Federal employees unless the agency 
has submitted a Standard Form 83, Clearance Request, and Notice of 
Action, to the Director of OMB, and the Director has approved the 
proposed collection of information. A person is not required to respond 
to a collection of information unless it displays a currently valid OMB 
control number.
    NIOSH has obtained approval from OMB to collect information from 
respirator manufacturers under OMB Control No 0920-109 (Respiratory 
Protective Devices), which covers all information collection under 42 
CFR part 84. This rulemaking would require NIOSH to collect new TIL 
testing information from manufacturers applying for approval of half-
mask air-purifying particulate respirators covered by this rulemaking.
    NIOSH estimates that the proposed TIL requirements will result in a 
minor increase in reporting burden to manufacturers. TIL testing would 
require the submission in the application package of one additional 
page of data describing the test results. These test results would 
already have been recorded by the applicant within the testing process 
so the only additional burden to the applicant would be any 
reformatting that might be necessary and the transfer of the results 
electronically to NIOSH. NIOSH anticipates this reporting, as part of 
the standard application package transmitted to NIOSH, would take no 
longer than 1 hour for completion; the current information collection 
approval pursuant to OMB Control No 0920-109 (Respiratory Protective 
Devices) estimates 86 hours per submission for each complete 
application under 42

[[Page 56149]]

CFR 84.11. Accordingly, in conjunction with this rulemaking, NIOSH will 
submit a request to OMB to amend its approval under OMB control No 
0920-109 to collect this additional information.
D. Small Business Regulatory Enforcement Fairness Act
    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS would 
report to Congress the promulgation of a final rule, once it is 
developed, prior to its taking effect. The report would state that HHS 
has concluded that the rule is not a ``major rule'' because it is not 
likely to result in an annual effect on the economy of $100 million or 
more.
E. Unfunded Mandates Reform Act of 1995
    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of federal regulatory 
actions on State, local, and tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
federal mandate that may result in increased annual expenditures in 
excess of $100 million by state, local or tribal governments in the 
aggregate, or by the private sector.
F. Executive Order 12988 (Civil Justice)
    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988, Civil Justice Reform and will not unduly burden 
the federal court system. NIOSH has provided TIL requirements it would 
apply uniformly to all applications from manufacturers of half-mask 
air-purifying particulate respirators. This proposed rule has been 
reviewed carefully to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
    HHS has reviewed this proposed rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The proposed rule does not ``have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)
    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this proposed rule on 
children. HHS has determined that the proposed rule would have no 
effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this proposed rule on energy supply, distribution, or use 
because it applies to the underground coal mining sector since coal 
mine operators are consumers of respirators. The proposed rule is 
unlikely to affect the cost of respirators used in coal mines and hence 
is not likely to have ``a significant adverse effect on the supply, 
distribution, or use of energy.'' Accordingly, this proposed rule does 
not constitute a ``significant energy action'' Under E.O. 13211 and 
requires no further Agency action or analysis.
J. Effective Date
    NIOSH proposes that the final rule would take effect 30 days from 
publication in the Federal Register for all new respirator approval 
applications for half-mask air-purifying particulate respirators. 
Approval holders could continue to sell and ship respirators certified 
under current provisions subpart K as NIOSH/MSHA certified respirators 
throughout a transition period of three years from the effective date 
of the final rule and NIOSH would continue to consider modifications to 
such approvals for two years from the effective date. Continued use of 
distributed respirators is under the jurisdiction of OSHA and MSHA and 
would not be affected by this rule. NIOSH anticipates that OSHA and 
MSHA would permit continued use of those respirators since 
certifications will not be revoked for respirators sold and shipped by 
the approval holder during the three-year transition period. The 
authority for an approval holder to sell and distribute under a NIOSH 
certification any half-mask air-purifying particulate respirator 
certified under the current provisions of subpart K would expire at the 
end of the three-year period.
    This 3-year transition period is proposed to ensure the timely 
replacement of respirators that demonstrate poor TIL performance while 
allowing an ample supply of respirators to remain available for use, 
since even a respirator with poor TIL performance may provide degrees 
of protection to different users. This timeframe would provide 
sufficient time for manufacturers to have respirators approved and 
manufactured in quantities to meet demand. According to NIOSH benchmark 
testing and other research, significant numbers of currently approved 
respirators of manufacturers with significant production capacity are 
likely to pass the proposed TIL testing and performance standards 
without modifications. On the other hand, NIOSH also seeks to ensure 
that total quantity of product supply remains sufficient during the 
transition period for current and potentially higher levels of demand. 
Such a demand spike could be anticipated if an influenza pandemic were 
to develop or increase in threat, instigating expanded stockpiling of 
respirators by health care, public health authorities, employers, 
workers, and the general public.
    NIOSH encourages the public to comment on this proposed 
implementation schedule and any related issues. Some specific issues 
for comment include the following:
    1. Do manufacturers believe they can meet the proposed TIL 
performance standards and testing requirements and provide adequate 
product supply to meet anticipated market demand within the proposed 3-
year deadline?
    2. Would any parties affected by this proposed rule incur an 
exceptional and unsupportable financial or other burden as a 
consequence of the proposed 3-year limit on the sale and distribution 
by approval holders of respirators certified under the current 
requirements (which omit TIL standards and testing)?
    3. Would a different implementation schedule be better justified in 
terms of balancing the public health, practical, and economic benefits 
of removing from the market NIOSH-approved respirators with inadequate 
TIL performance against the public health, practical, and economic 
benefits of ensuring that an adequate supply of NIOSH-approved 
respirators remains constantly available? Please describe the 
advantages and disadvantages of extending or contracting the 
implementation schedule.
    4. Are other factors that have not been identified by NIOSH 
important to deciding an appropriate implementation schedule?

List of Subjects in 42 CFR Part 84

    Mine safety and health, Occupational safety and health, Personal 
protective equipment, Respirators.

[[Page 56150]]

Text of the Proposed Rule

    For the reasons discussed in the preamble, NIOSH proposes to amend 
42 CFR part 84 as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

    1. The authority citation for Part 84 continues to read as follows:

    Authority:  29 U.S.C. 651 et seq., and 657(g); 30 U.S.C. 3, 5, 
7, 811, 842(h), 844.

Subpart K--Non-Powered Air-Purifying Particulate Respirators

    2. Amend Sec.  84.175 by revising the heading and adding new 
paragraphs (a)(3), and (g) through (i) to read as follows:


Sec.  84.175  Half-mask facepieces, full facepieces, hoods, helmets, 
and mouthpieces; fit and total inward leakage (TIL); minimum 
requirements.

    (a) * * *
    (3) Half-mask facepieces may be designed and constructed to fit 
only one or more defined subpopulations of the general population of 
respirator users, such as ``women'' or persons with faces within 
specific dimensional limits, provided that the membership of the 
subpopulation is readily discernable by the intended users.
* * * * *
    (g) Any respirator part that must be removed by the respirator user 
to perform a user seal check shall be replaceable without special tools 
and without disturbing the facepiece seal.
    (h) User instructions for half-mask respirators shall specify 
information necessary to identify the intended population of users:
    (1) The applicant shall specify in the user instructions the face 
size or sizes that the respirator is intended to fit; pursuant to this 
requirement, one respirator may be intended to fit all face sizes; and
    (2) If appropriate pursuant to paragraph (a)(3) of this section, 
then the applicant shall also specify in the user instructions any 
additional descriptions necessary to indicate the subpopulation(s) the 
respirator is intended to fit, such as sex, general facial 
characteristics, and/or precise facial measurements.
    (i) Half-mask respirator TIL\1\ testing requirements:
---------------------------------------------------------------------------

    \1\ TIL is the combination of contaminated air leaked through 
various potential sources including the facepiece-to-face seal, 
exhalation valves (if any), and gaskets (if any) and any 
contaminants that have penetrated the filter.
---------------------------------------------------------------------------

    (1) NIOSH will employ specifications provided in user instructions, 
pursuant to paragraphs (h)(1) and (h)(2) of this section, to select 
representative test subjects for TIL testing, without further guidance 
from the manufacturer. NIOSH will conduct testing on 35 test subjects 
for a respirator of a single size or multiple sizes intended to fit the 
general population of respirator users, or on 15 or more test subjects 
for a respirator of a single size or multiple sizes designed to fit one 
or more specific subpopulations of respirator users.
    (2) Immediately before each test, test subjects will conduct the 
user seal check or other donning procedures as specified in the user 
instructions.
    (3) The TIL test shall be administered to each test subject up to 
three times, terminating testing either when a test has produced a TIL 
value of 1.0 percent or less or after the third test administered to 
the test subject, whichever occurs first.
    (4) A TIL value of 1.0 percent or less shall be achieved by at 
least:
    (i) 26 out of 35 test subjects for a respirator of a single size or 
of multiple sizes, designed to fit the general population of respirator 
users; or
    (ii) 12 out of 15 test subjects (or 80 percent of test subjects if 
there are more than 15) for a respirator of a single size or multiple 
sizes designed to fit one or more specific subpopulations of respirator 
users.
    (5) Each respirator used for testing will be probed approximately 
halfway between the wearer's nose and mouth.
    (6) The TIL will be measured in the presence of a sodium chloride 
challenge aerosol with a concentration of 1,500 to 3,000 particles/
cm\3\ within the size range of 0.02 to 0.06 micrometers.
    (7) The TIL will be measured while the following sequence of test 
exercises is conducted:
    (i) Normal breathing;
    (ii) Deep breathing;
    (iii) Turn head side to side while pausing for two normal 
inhalations at each side;
    (iv) Move head up and down while pausing for two normal inhalations 
in the head up position and in the head down position;
    (v) Recite the Rainbow Passage;\2\
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    \2\ The Rainbow Passage is a public domain text used in 
respirator testing to fully challenge the face seal to distortions 
that might arise from talking while wearing the respirator. It is 
widely available on the internet using any Internet search engine by 
entering ``Rainbow Passage.'' It is also available in the OSHA 
respirator rule at 29 CFR 1910.134 Appendix A, part I.A.14(a)(5).
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    (vi) Reach for the floor and ceiling while pausing for two normal 
inhalations in the arms-up position and in the arms-down position;
    (vii) Grimace (measurements during the grimace are not included in 
the TIL determination); and
    (viii) Normal Breathing.
    (8) Each test exercise will be performed using the OSHA protocol as 
specified at 29 CFR 1910.134 Appendix A, Part I.A.14.(b).
    (9) The facepiece position will not be adjusted once the TIL test 
exercises begin; any adjustment performed will void the test and the 
test will be repeated in its entirety.
    (10) The TIL will be determined by the ratio of the averages of the 
sodium chloride aerosol challenge concentration inside the facepiece to 
the challenge concentration outside the facepiece during the test; the 
TIL results will be expressed as a percentage: TIL = [Cin/
Cout] x 100%.
    (11) The instrumentation used to measure the concentration inside 
and outside the facepiece will:
    (i) Utilize a condensation nuclei counter;
    (ii) Measure only the concentrations of sodium chloride challenge 
aerosol in the approximate size range of 0.02 to 0.06 micrometers (mass 
median aerodynamic diameter); and
    (iii) Respond linearly to changes in the aerosol concentration, 
within 5 percent, over the ambient concentration range of 
70 to 3,000 particles/cm\3\ and TIL <= 5.0 percent, within the particle 
size range of 0.02 to 0.06 micrometers.
    3. Amend Sec.  84.205 by revising paragraphs (c), (d) and (e) to 
read as follows:


Sec.  84.205  Facepiece test; minimum requirements.

* * * * *
    (c) Any chemical cartridge respirator part which must be removed to 
perform the facepiece or mouthpiece user seal check shall be 
replaceable without special tools and without disturbing facepiece or 
mouthpiece fit.
    (d) The facepiece or mouthpiece user seal check using the positive 
or negative pressure recommended by the applicant and described in his 
instructions will be used before each test.
    (1) Each wearer will enter a chamber containing 100 p.p.m. isoamyl 
acetate vapor for half-mask facepieces, and 500 p.p.m. for full 
facepieces, mouthpieces, hoods, and helmets.
    (2) The facepiece or mouthpiece may be adjusted, if necessary, in 
the test chamber before starting the test.
    (3) Each wearer will remain in the chamber for 8 minutes while 
performing the following activities:
    (i) Two minutes, nodding and turning head;
    (ii) Two minutes, calisthenic arm movements;

[[Page 56151]]

    (iii) Two minutes, running in place; and
    (iv) Two minutes, pumping with a tire pump into a 28-liter (1 
cubic-foot) container.
    (4) Each wearer shall not detect the odor of isoamyl-acetate vapor 
during the test.
    (e) In addition, any combination half-mask chemical cartridge/
particulate filtering respirator shall meet the TIL testing 
requirements specified in paragraph (i) of Sec.  84.175.

    Dated: August 18, 2009.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. E9-26008 Filed 10-29-09; 8:45 am]
BILLING CODE 4163-18-P