[Federal Register Volume 74, Number 209 (Friday, October 30, 2009)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26008]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 84
Total Inward Leakage Requirements for Respirators
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Notice of proposed rulemaking.
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
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].
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
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.
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
\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.
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
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
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
benchmark testing. This finding is supported by published
\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.
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.
\6\ NIOSH/BLS . 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.
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.
\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.
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
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
\8\ 29 CFR 1910.134, Appendix A, Part I, C, 3.
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
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
\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:
\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).
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\
\12\ 29 CFR 1910.134(f)(7).
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
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
Section 84.175 Half-Mask Facepieces, Full Facepieces, Hoods, Helmets,
and Mouthpieces; Fit and Total Inward Leakage (TIL); Minimum
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
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
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
B. Half-Mask Respirator TIL Testing Requirements
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
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.
\13\ See 29 CFR 1910.134(f)(7).
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
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
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.
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
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,
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
\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
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
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
\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.
\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
\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
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
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
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
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
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
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-
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
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.
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
(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
(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
(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
(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
(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\
\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).
(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
(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;
(iii) Two minutes, running in place; and
(iv) Two minutes, pumping with a tire pump into a 28-liter (1
(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.
Secretary, Department of Health and Human Services.
[FR Doc. E9-26008 Filed 10-29-09; 8:45 am]
BILLING CODE 4163-18-P