# Respiratory Protective Devices

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URL: https://www.frixlaw.com/law-library/documents/fr%3A95-13287

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** June 8, 1995
- **Citation:** 60 FR 30336

## Text

SUMMARY: This final rule addresses NIOSH and the Department of Labor/
Mine Safety and Health Administration (MSHA) certification requirements
for respiratory protective devices. Specifically, the rule replaces
MSHA regulations with new public health regulations, while also
upgrading testing requirements for particulate filters.
This action is the first of a series of modules that will
incrementally upgrade current respirator approval requirements. This
modular approach will allow improvements to be implemented on a safety
and health priority basis as well as facilitate adaptation to new
requirements by the manufacturers and users of respirators. It will
also expedite the incorporation of technological advancements and will
allow for the expeditious response to emerging hazards.
Except for the particulate-filter requirements, most requirements
of the existing regulations are incorporated into the new regulations
without change. The revised testing requirements for particulate
filters significantly improve the effectiveness of evaluating air-
purifying filters to remove toxic particulates from the ambient air.
These requirements are consistent with two decades of advances in
respiratory protection technology.
The certification of air-purifying respirators under the final rule
will also enable respirator users to select from a broader range of
certified respirators that meet the performance criteria recommended by
CDC for respiratory devices used in health-care settings for protection
against Mycobacterium tuberculosis (Mtb), the infectious agent that
causes tuberculosis (TB).
Elsewhere in this separate part of the Federal Register, MSHA is
publishing a final rule to remove existing regulations which are made
obsolete by this final rule.

EFFECTIVE DATES: This final rule is effective on July 10, 1995. The
incorporation by reference of certain publications used in the
regulations is approved by the Director of the Federal Register as of
July 10, 1995.

FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, NIOSH, 1095
Willowdale Road, Morgantown, West Virginia 26505-2888. The telephone
number is (304) 285-5907.

SUPPLEMENTARY INFORMATION:

I. Availability of Copies and Access to Final Rule

Additional copies of this final rule can be obtained by calling the
NIOSH toll-free information number (1-800-35-NIOSH, option 5, 9:00 AM-
4:00 PM ET). Arrangements have also been made for this final rule to be
listed on the electronic bulletin boards of the Government Printing
Office and of the Department of Labor; the telephone numbers are (202)
512-1387 and (202) 219-4784, respectively. This final rule may also be
obtained from the NIOSH Home Page on the World-Wide Web. The location
for the NIOSH Home Page is http://www.cdc.gov/niosh/homepage.html.

II. Paperwork Reduction Act

This final rule contains information collections that have been
approved by the Office of Management and Budget under the Paperwork
Reduction Act of 1980 and assigned control Number 0920-0109. The title,
description, and respondent description of the information collection
are shown below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Respiratory Protective Devices.
Description: This rule prescribes requirements and procedures which
must be met in filing applications for approval by NIOSH of respirators
and modifications of respirators.
Description of Respondents: Businesses and other for-profits.
Estimated Annual Reporting and Recordkeeping Burden:

----------------------------------------------------------------------------------------------------------------
Annual
Section number of Annual Average burden per Annual burden
respondents frequency response hours
----------------------------------------------------------------------------------------------------------------
84.35......................................... 56 10.5 79.45 hr............ 46,716 hr.
84.41......................................... 56 10.5 22.70 hr............ 13,347 hr.
84.43......................................... 56 10.5 56.75 hr............ 33,369 hr.
-----------------------------------------------------------------
Total................................... ........... ........... .................... 130,805 hr.
----------------------------------------------------------------------------------------------------------------

The above citations are currently cleared under 30 CFR Part 11 as OMB
control Number 0920-0109.
A Paperwork Reduction package is being submitted to OMB, requesting
approval of the requirement for labeling to be effected by Sec. 84.33.
A document will be published in the Federal Register when such approval
has been obtained.

III. Background

NIOSH published a proposed rule (59 FR 26850) to establish a new 42
CFR part 84, on May 24, 1994. On May 26, 1994, NIOSH published a notice
in the Federal Register (59 FR 27257) for an extension of the public
comment period and a rescheduling of a public meeting. A public meeting
was held to obtain comments on the proposal in Washington, D.C. on June
23-24, 1994.
The proposal and public meeting received response from the full
complement of affected parties in the public. Commenters included
safety professionals, respirator manufacturers, representatives of
industrial and health-care facilities, and workers' associations. Three
hundred and three commenters responded to the proposed rule. One
hundred twenty six commenters represented health-care workers. Ninety
six commenters represented health-care facilities. Fifteen commenters
represented associations of health-care professionals. Fifteen
commenters represented associations of health-care facilities.
Seventeen commenters represented respirator manufacturers. Eight
commenters represented trade or manufacturers' associations. Eight
individuals commented as private citizens. Six commenters represented
regulatory agencies (federal, state, [[Page 30337]] county). Five
commenters represented respiratory protection experts. Three commenters
represented workers' organizations. Two commenters represented test
instrument manufacturers. One commenter represented industrial hygiene
professionals. One commenter represented a Federal Advisory Committee.
These figures include the 18 presenters at the Public Meeting held in
Washington, D.C. on June 23 and 24, 1994.

IV. Summary of Major Changes in Response to Comments

The requirements of the final rule differ from those proposed (59
FR 26850) in 8 major areas. These changes, discussed in sections V.
Administrative and Procedural Matters of Final Rule and VI. Discussion
of Final Rule, are summarized as follows:
1. Three categories (series) of particulate filters (N-, R-, and P-
series) are included rather than two (solid and liquid and solid);
2. Maximum allowable inhalation and exhalation airflow resistance
values have been slightly increased and labelling changes are included
to identify the certified efficiency level to users;
3. The new certification categories apply only to non-powered air-
purifying respirators. Powered air-purifying particulate respirators
(PAPRs) will be approved only with filters meeting the requirements for
30 CFR part 11 high-efficiency filters;
4. A new subpart KK has been added for the issuance of extensions
of existing 30 CFR part 11 approvals to address respirator non-
conformances when there is a demonstrated safety or health need during
the transition period and for the approval of PAPRs;
5. Fit testing during the certification process is not included for
particulate respirators;
6. The number of tested units has been reduced and the test data
will no longer be treated statistically;
7. The period for sale and shipment of 30 CFR part 11 certified
particulate respirators has been increased. The period for processing
part 11 applications has been eliminated, except for demonstrated need;
and
8. Testing parameters are stated more explicitly.
A summary listing of the section-by-section changes from the
proposal to this final rule is provided in Appendix A--Comparison of
Technical Requirements Final Rule to Proposed Rule. Each of these
changes is discussed in detail in the following preamble.

V. Administrative and Procedural Matters of Final Rule

A. Modular Approach

The proposed rule explained the intent to promulgate modifications
to the requirements of 30 CFR part 11 in a series of modules. There are
numerous benefits to utilizing a modular approach to promulgate changes
to the existing requirements. Among these are the following
considerations:
1. Improvements can be implemented on a priority basis, assuring
that those expected to contribute most to improving worker protection
are implemented first;
2. Incremental promulgation of improvements should facilitate
adaptation to new requirements by the respirator manufacturer and user
communities, minimizing the potential for any disruption in the supply
of certified respirators;
3. Public participation in the rulemaking process will be
facilitated by proposing important regulatory changes in individual
segments of separate rulemaking; and
4. Improvements made to limited segments of the rule can be
implemented in a much shorter time period than comprehensive revisions
to the entire rule. Therefore implementation of technological
advancements and response to emerging hazards will be expedited.
Comments overwhelmingly endorsed the concept of the modular
approach with only two comments specifically opposed to this approach.
More than 250 comments supported the proposal's approach and
approximately 40 specifically endorsed and offered recommendations for
changes in the modular scheduling. Some commenters expressed concerns
about this new rulemaking procedure. These predominantly questioned the
interaction of modules and implementation schedules. Module interaction
concerns included added costs, confusion, transition periods
(grandfathering) of interrelated modules, and redesign of respirators
due to effects of multiple modules. Concerns of scheduling included the
priority of modules, additional module topics, transition periods for
products to meet prior requirements, timetable for completion of
revisions, and availability of NIOSH resources to support work on
multiple modules simultaneously.
The modular approach represents a continuous improvement strategy
for rulemaking. With this process, NIOSH expects regulations and
products to be incrementally improved and updated to address worker
health concerns and prevent any disruption in the supply of
respirators. Each module will constitute a separate rulemaking
activity. The modular approach undertaken by NIOSH provides clear
advantages over the comprehensive approach to rulemaking. No specific
time period has been identified in which all certification standards
will be revised. The Institute recognizes that a predetermined revision
cycle could ensure the periodic re-examination of standards. However, a
requirement of this type would also diminish the capability of the
Institute, with its limited resources, to address priority respiratory
protection needs. The Institute has determined that a flexible approach
is required that will permit expeditious responses to emerging
respiratory protection priorities. These can change rapidly as
technological advancements, international harmonization, changed
working conditions, or the emergence of new hazards make current
standards obsolete. As discussed below the Institute will balance
industry's need for planning and adjustment time associated with future
modules by having ample public involvement in setting the priorities
for module selection and with judicious selection of transition
periods.
NIOSH is aware of the needs of the respirator community to be able
to plan future production and purchasing needs. This is true for
consumers as well as manufacturers of respirators. NIOSH announced at
the informal public meeting its intention to hold ample public meetings
in advance of any proposed future modules so that these concerns could
be addressed. The concerns expressed in the comments can be addressed
in these informal public meetings and with the use of appropriate
transition periods.
NIOSH intends to establish transition periods for implementing the
requirements of each module. These transition periods will be
determined by an assessment of the industry's ability to adopt the new
requirements, ongoing transition periods from prior modules, and the
public health implications of the changes.
Anticipated subjects and sequence of the NIOSH rulemaking were
outlined in the proposed rule. Numerous comments were received
providing suggestions for additional module subjects and their
priority. Suggested additional subjects included powered air-purifying
respirators, smoke masks, fit testing, supplied air respirators, gas
masks, and combination respirators. Suggestions on scheduling
priorities indicated a diversity in perceived needs. Based on the
public interest in the future module [[Page 30338]] subject areas and
timetable, NIOSH will conduct a public meeting to further develop the
schedule with input from all interested parties. The location and date
for this meeting will be announced in the Federal Register, Morbidity
and Mortality Weekly Report (MMWR), and other media.
The Institute coordinated the development and implementation of the
modular approach with OSHA and MSHA. The specific requirements of this
first module were reviewed and accepted by both agencies to ensure that
42 CFR part 84 properly links with OSHA and MSHA respirator use
regulations. Both agencies will participate in the development by NIOSH
of appropriate user guidelines. NIOSH and MSHA developed a Memorandum
of Understanding to delineate roles for the continuing joint approval
under 42 CFR part 84 of respirators used for mine emergencies and mine
rescue. The Institute will continue to collobrate with MSHA and OSHA as
future modules are developed.

B. User's Guide

The proposal stated the intent to develop a user's notice or guide
to explain the use of respirators certified for protection against
particulate exposures under the new 42 CFR part 84 that would replace
the existing filter respirators certified under 30 CFR part 11 subparts
K and M. Commenters indicated that this user's guide should be
developed in a public forum with public involvement. One commenter
stated that the user's guide should be issued prior to the finalization
of part 84. Another believed that its availability should coincide with
the publication of the final rule. Constraints on releasing specific
information as to the contents of the final rule prior to its
publication limits the availability of information needed for
development of a user's guide, thus making its development with public
input prior to or concurrent with this rule impossible. NIOSH agrees
with the commenters that public input into the user's guide will result
in a better product. An informational respirator user's guide for part
84 respirators will be developed with public involvement.
The user's guide will address both the use of part 11 and part 84
respirators during the transition period. Assigned Protection Factor
(APF) values are used in the respirator selection process to indicate
the expected protection level for the respirator wearer. NIOSH
recommends APFs for respirators certified under 30 CFR part 11 in its
Guide to Industrial Respiratory Protection and in the Respirator
Decision Logic. The future user's guide will recommend APFs appropriate
for use with the part 84 particulate respirators until APFs can be
addressed through future rulemaking. It will also provide information
and recommendations on a variety of other respirator use issues
associated with this current rulemaking.
During review of this rule, both OSHA and MSHA expressed strong
interest in the APF values for the new part 84 particulate filter
classifications. Both agencies agreed with NIOSH that APFs could not be
addressed properly in this first module. They therefore urged NIOSH to
develop a subsequent module defining APFs for all respirators. In the
interim, OSHA regulations under Title 29 and the MSHA regulations under
Title 30 will allow the use of the new part 84 particulate
classifications with the APFs to be established by NIOSH in the users'
guide. OSHA is in the process of updating its respirator use
regulations, and the current proposal specifies acceptance of APFs
developed and promulgated under part 84.

C. Use of Particulate Respirators for Protection Against TB

While the requirements in this final rule were not developed
specifically to certify respirators against biological agents, this
rule will address the important public health need to control the
transmission of Mycobacterium tuberculosis, the causative agent of TB,
in health-care and other facilities through the use of respiratory
protective devices.
In response to the recognized risk of TB transmission in health-
care facilities, increases in TB in many areas, and recent outbreaks of
multidrug-resistant TB, CDC published ``Guidelines for Preventing the
Transmission of Mycobacterium tuberculosis in Health-Care Facilities,
1994'', in the Federal Register (59 FR 54242) and MMWR (Volume 43, No.
RR-13) on October 28, 1994. These guidelines enumerate four performance
criteria that CDC has determined are necessary for respiratory
protective devices used in health-care settings for protection against
TB. The only currently certified air-purifying respirator class that
meets all the respiratory protection performance criteria in the CDC
Guidelines is a respirator with a high efficiency (HEPA) filter. Many
comments were received from the health-care community supporting the
positive impact of the proposed rule on compliance with the CDC
Guidelines.
All nine classes of air-purifying, particulate respirators to be
certified under the provisions of the new particulate filter tests
(filter efficiency) in part 84 meet or exceed the performance
recommendations contained in the CDC Guidelines. Several of these new
classes of air-purifying, particulate respirators are expected to be
less expensive than respirators with HEPA filters. Consequently,
implementation of the modifications included in this rule should
promote a substantial increase in respiratory protection provided to
health-care and other workers potentially exposed to the M.
tuberculosis droplet nuclei in health-care and other occupational
settings.

D. Conversion From 30 CFR Part 11 to 42 CFR Part 84

Since 1974, the Mine Enforcement and Safety Administration (MESA),
MSHA, and the Occupational Safety and Health Administration (OSHA) have
regulated the selection, use, and maintenance of respirators in the
workplace under their respective enforcement authorities. NIOSH is not
including the requirements of Secs. 11.2 and 11.2-1 with this
redesignation to 42 CFR part 84. Sections 11.2(a) and 11.2-1 refer to
respirator use and selection criteria that since have been superseded
by OSHA and MSHA respirator regulations.
Section 11.2(b) allows for the continued manufacture and sale of
gas masks approved under the former U.S. Bureau of Mines (BOM) Schedule
14F (dated April 23, 1955). This Schedule was replaced by the
requirements in Subpart I of 30 CFR part 11 in 1972. Gas masks approved
under Subpart I of 30 CFR part 11 (14G canisters) are widely available
and only a limited number of types of 14F canisters are marketed. MSHA
experience indicates that few of the 14F respirators are currently sold
or used. MSHA also indicated that removal of the provisions in
Sec. 11.2(b) would remove the authority to market these respirators as
approved devices.
NIOSH is not transferring the requirements of Sec. 11.2(b) to 42
CFR Part 84 since NIOSH does not have the capability to process
applications for these respirators. The approval records on these BOM-
approved respirators no longer exist and therefore NIOSH has no way of
monitoring the production of these respirators to assure that they
continue to meet the approved design. Thus, NIOSH will not authorize
the sale and shipment of the Schedule 14F respirators under this part
84.
In addition, the codification of the redesignated sections into a
non-hyphenated numbering system results in several general heading
sections that contained no substantive requirements [[Page 30339]] not
being included in this redesignation. These include Secs. 11.85,
11.102, 11.124, 11.140, and 11.162.
NIOSH is making a limited revision to the existing requirements of
30 CFR part 11 in this first module, requiring updated particulate
filter tests. This revision eliminates the need for unique tests for
particulate respirators used for different types of aerosols, such as
dust/mist, dust/fume/mist, paint spray, and pesticides. The new
certification tests use the most penetrating aerosol size,
0.3m, and either a non-degrading particulate, sodium chloride,
or a highly degrading oil, dioctylphthalate. Consequently, particulate
filters certified under these new procedures can be used without regard
to aerosol size, taking into consideration only the degrading or
nondegrading nature of particulates and the APF required by exposure
concentrations. To revise respirator nomenclature to be consistent with
this fundamental change in certification philosophy, the words dust,
fume and mist are replaced with particulate in the final rule.
Existing subpart M of part 11 (Secs. 11.170 through 11.183-7)
addresses the requirements for pesticide respirators. The requirements
of subpart M are not included in this redesignation to 42 CFR part 84.
This rule eliminates this category and the tests specific to it,
leaving subpart M reserved. All references to subpart M and pesticides
as a classification for approval are eliminated. NIOSH will discontinue
issuance of certifications that classify these respirators as suitable
for use against a specific particulate.
The existing test requirements in Secs. 11.124-21 through 11.124-24
specify that a test subject wearing the respirator be exposed to an
abrasive blasting environment in which the blasting agent is composed
of 99+ percent free silica (SiO2). This requirement is not
included in this redesignation to 42 CFR part 84. The purpose of this
requirement was to determine the adequacy of protection provided in
such environments. NIOSH administratively suspended such tests over 20
years ago because they placed test subjects at risk of exposure to
fractured crystalline silica. These tests are not included in this
final rule. Requirements for abrasive blasting and other atmosphere
supplying respirators as well as fit testing for all respirator types
will be addressed in a future module. In the interim, NIOSH will
continue the administrative policy of the past two decades of
conducting quantitative fit testing in lieu of the tests stipulated in
Secs. 11.124-21 through 11.124-24.
Two comments recommended the inclusion of administrative policies
to the rule. One commenter suggested that Secs. 11.124-21 through
11.124-24 (referring to air-line respirators) be restored or replaced
with the current administrative policy of quantitative fit testing.
Another commenter was concerned that the NIOSH policy of allowing a
mixed-gas Self Contained Breathing Apparatus for fire fighting was not
included in the proposed rule. NIOSH agrees with these commenters that
administrative policies related to specific changes in a module should
be incorporated. However, the topics of concern to these commenters
addressed administrative policies in subject areas that were not
proposed to be changed in this module, therefore, they have not been
incorporated.
NIOSH has not included the test procedures of Secs. 11.124-21
through 11.124-24 due to NIOSH's concern of health risks to test
subjects during pre-submission testing performed by a manufacturer
seeking approval of a respirator intended for use in an abrasive
blasting environment. Although no Type AE or BE respirators have ever
been certified, Type AE, BE, and CE respirators may be certified for
use in an abrasive blasting environment. These respirators will be
tested using Air-supplied Respirator Section Test Procedure Number 23
Abrasive-Blast, Type CE. Copies of this procedure are available from
the Certification and Quality Assurance Branch, 1095 Willowdale Road,
Morgantown, West Virginia, 26505-2888.

E. MSHA's Regulatory Role

The final 42 CFR part 84 regulation is consistent with the current
MSHA and NIOSH respirator approval program, placing responsibility for
certifying most respirators with NIOSH. MSHA and NIOSH will continue to
jointly review and approve respirators used for mine emergencies, mine
rescue, and the associated service-life plans, user's manuals, and
other documentation. Among the types of devices for which this role is
particularly important are self-contained self-rescue devices. The
final rule preserves MSHA's current role in the certification of such
respirators whose unique use in mining is an important part of
safeguarding the health and safety of miners. In addition, MSHA will
continue to test electrical and electronic components of respirators
for use in potentially explosive atmospheres in gassy underground mines
and issue a separate MSHA approval under 30 CFR part 18 for the
electrical components of such respirators.
In implementing the final regulation, NIOSH and MSHA have developed
a new Memorandum of Understanding (MOU) that reflects administrative
matters related to respirator approval, including immediate
notification to MSHA of field complaints and identified deficiencies
concerning approved respirators. Three commenters recommended that the
public be allowed to review and comment on the MSHA/NIOSH Memorandum of
Understanding. It was indicated by an agency representative that such
comments on the contents of the MOU would be welcomed. Two of these
commenters were concerned that the responsibilities and accountability,
specifically MSHA's involvement in the certification of mining-specific
respiratory protective devices, be maintained in the Memorandum of
Understanding. The third commenter was unsure if the Memorandum of
Understanding would have an effect on the notice of public rulemaking.
Comments submitted subsequent to the public meeting reiterated the
concerns stated at the meeting. These comments were considered in the
MOU's development and have subsequently been addressed. Copies of the
MOU will be available from NIOSH and MSHA.
The new Memorandum of Understanding between MSHA and NIOSH
delineates the interaction between the agencies in carrying out the
responsibilities and authorities provided for in the Mine Safety and
Health Act of 1977 (30 USC Sec. 801 et seq) and this final rule. It
defines the method of implementation of the regulation and has no
effect on its content. The agency has determined that this MOU is most
appropriately developed between the two agencies and thus, commenters
did not directly participate in the development of the MOU. As
indicated above, public comments on the MOU are welcome.

F. Transition Period

The proposal included provisions for phasing out part 11
particulate respirators. Specifically, no applications were to be
accepted after the effective date of part 84, with a maximum of 6
months for processing in-house applications. Sale and shipment
(distribution) of part 11 particulate respirators would have been
allowed for only 2 years from the effective date of part 84.
Several commenters indicated that these transition periods were
much shorter than the 5-year phase-out period proposed by NIOSH in
1987. Some comments on the proposed schedule stated that there must be
an appropriate [[Page 30340]] time to develop new products, receive
certification, and initiate production of the new respirators.
Commenters were also concerned the use of the term distribution implied
manufacturer control of the distributer system and the resale market.
Several commenters recommended 4 years for NIOSH-processing of part 11
applications, and for sale and shipment of part 11 respirators. NIOSH
is expanding the phase-out period from two to three years to address
these concerns.
With the effective date of part 84, MSHA and NIOSH will no longer
accept applications for new approvals or extensions of approval of
respirators under part 11 provisions. All applications received after
the effective date of part 84 will be considered as applications for a
new or extension of approval under part 84. Valid part 11 applications
that were received prior to the effective data of part 84 will be
processed for approval under part 11 provisions. A subpart KK
containing the part 11 requirements for particulate respirators has
been added to the final rule to provide continued authority for NIOSH
to issue extensions of approvals needed to address respirator recall
and retrofit matters that are associated with health and safety issues
for workers. Respirators listed as certified under the provisions of 30
CFR part 11, subparts K or M, may not be sold or shipped by the
approval holder as NIOSH/MSHA certified respirators effective July 10,
1998. Continued use of distributed particulate respirators is under the
jurisdiction of OSHA and MSHA and therefore is not affected by this
rule. Because certifications will not be revoked for part 11 devices
sold and shipped by the approval holder prior July 10, 1998, NIOSH
anticipates that OSHA and MSHA would permit continued use of those part
11 respirators.
This 3 year period was selected to ensure the timely replacement of
the part 11 respirators that exhibit low initial efficiency levels
while allowing an ample supply of respirators to remain available for
use. This timeframe will provide sufficient time for manufacturers to
have respirators approved and manufactured in quantities to meet
demand. Manufacturers' comments to the proposed rule support this
timeframe, as some manufacturers appear ready to provide part 84
respirators immediately. At least one commenter stated, without
reservation, preparedness to submit applications to meet the new
requirements. Several commenters requested that NIOSH accept
applications for part 84 respirators upon publication, rather than the
effective date of part 84. One manufacturer commented that NIOSH should
anticipate at least 10 applications from each manufacturer upon part 84
becoming effective. NIOSH also expects a significant number of
presently certified particulate respirators, in addition to new
designs, to meet the requirements of this rule. Therefore, a high
initial application rate for approval of part 84 particulate
respirators is expected.
Some commenters expressed concern that NIOSH would not be able to
expeditiously process the part 84 applications, thereby delaying
introduction of the new respirators to the marketplace. Delays in
processing the part 84 applications would prolong the time needed for
transition to these new respirators. Division of the NIOSH staff and
resources between processing part 84 applications and pending part 11
applications, along with routine extensions of existing part 11
particulate respirator certifications, may initially slow the
certification and availability of part 84 respirators. However, the
Institute has determined that it cannot reject without action part 11
applications that were validly prepared and submitted while the
provisions of part 11 remain in effect. NIOSH therefore will process
all valid part 11 applications that were received by NIOSH before the
effective date of part 84. The authority for the approval holder to
sell and ship particulate respirators under any part 11 certification
issued under these conditions will expire along with the other part 11
certifications on July 10, 1998.
The new technical requirements of part 84 only address air-
purifying respirators. Other classes of respirators, such as self-
contained breathing apparatus, gas masks, etc., are not affected by the
new filter penetration test requirements. Therefore, NIOSH intends to
continue issuing new and extension of approval numbers in the same
format designation (TC number) as issued under existing part 11 for
those respirator types whose technical requirements for approval under
part 84 have not been modified from existing part 11. A new approval
number series will be initiated for the products whose technical
requirements have been upgraded under part 84. By checking the approval
number, respirator users will be able to quickly and easily distinguish
those products that have demonstrated the improved performance
requirements of the new part 84 from those that have demonstrated
compliance with only the existing part 11 standards that are
transferred to part 84. NIOSH further intends to issue public notices
of the new approval designations to be used for products demonstrating
performance to the improved standards.

VI. Discussion of Final Rule

A. Certification Fit Testing

The proposal contained two sections (Secs. 84.181 and 84.182) that
would have retained the existing Part 11 particulate respirator fit
test protocols using isoamyl acetate. These tests were proposed to
redesignate the existing Secs. 11.140-1 and 11.140-2 with the tests
unchanged to minimize the scope of the changes proposed in the first
module.
The currently required particulate respirator facepiece fit tests
of part 11 use isoamyl acetate, an organic vapor, as the test agent.
Under existing part 11, such tests are required for high efficiency
(HEPA) and dust, fume, and mist (DFM) respirators, but not dust/mist
(DM) respirators. Since particulate filters are not intended to filter
organic vapors, the tested respirators must often be modified by the
addition of an activated charcoal layer. This added charcoal layer
prevents penetration of the isoamyl acetate through the filter so that
the respirator-to-face fit can be evaluated. As a result, the
certification program tests surrogate respirators that may have fitting
characteristics that differ from the marketed (certified) respirators.
Numerous and varied comments were provided on these sections. A
number of commenters suggested that NIOSH eliminate fit testing as a
condition of certification. Two commenters recommended that the rule
should require manufacturers to submit test data showing good fit
characteristics in lieu of NIOSH conducting fit testing. Other
commenters requested that NIOSH test the respirator-to-face fit, or
otherwise assure that proper fitting characteristics were provided by
every certified respirator. Several other commenters requested that fit
testing be made a meaningful test. Several others suggested that a
quantitative protocol rather than a qualitative fit protocol should be
used. Two commenters stated support for the fit tests as proposed.
Several of the reasons given for eliminating fit testing were that
fitting respirators to individuals in the certification program does
not predict the fit of an individual wearer; fit testing of individual
workers at the worksite is required by OSHA and that is the appropriate
setting for fit testing; the isoamyl acetate test has not been
validated; and, the isoamyl acetate test [[Page 30341]] has to be
performed on modified respirators.
The comments requesting that fit testing be made a meaningful test
were based on reasoning similar to those suggesting elimination of the
test. In lieu of elimination, they suggested that some inadequacies
could be resolved with modification of the test protocol to use a
particulate aerosol, such as Bitrex, as the test agent. Changing the
test protocol to test with a particulate would at least permit the
tested respirator filters to be as certified, thereby eliminating
specially-made surrogates.
Commenters endorsing NIOSH continuation of fit testing believed
that the present certification process provides an assurance that the
respirator will properly fit a given worker when use of the respirator
is needed in the workplace.
The problems associated with testing the facepiece-fit in a
certification program have been recognized for years. Efforts have been
made to seek more meaningful test results; nevertheless, the validity
of the test results remain questionable.
Successful fit testing in the certification process provides no
assurance that the respirator will properly fit a given worker when
used in the workplace. The only means presently available to assess the
fit achieved on the worker is a respirator-to-face fit test conducted
on that individual with the chosen respirator. Even this test
procedure, conducted on the individual, cannot assure that the
respirator will maintain a proper fit when use of the respirator is
needed in the workplace. This concern is compounded when the fit is
determined with a surrogate respirator.
During review of this rule, both OSHA and MSHA favored inclusion of
respirator fit testing and fit checking procedures as part of NIOSH
respirator certifications under the new part 84 particulate filter
classifications. Both agencies accepted the determination by NIOSH that
these issues cannot be properly addressed in this first module. Both
agencies therefore urged NIOSH to develop a face fit module to include
respirator fit testing and fit checking procedures for all respirators.
The purpose of face fit testing in the certification program has
been to assure that respirators have generally good face fitting
characteristics. However, at this time NIOSH does not have studies that
define the effectiveness of either the isoamyl acetate or American
National Standards Institute (ANSI)/OSHA accepted fit tests in
predicting actual workplace protection provided to workers. NIOSH is
presently conducting research for this purpose. In the interim, lacking
validation and correlation of testing protocols, workers' health
concerns are best served through the application of fit-testing and
fit-checking procedures on individual workers in a quality respirator
program. Therefore, the isoamyl acetate fit tests proposed in
Secs. 84.181 and 84.182 are not included in this final rule. NIOSH will
address issues associated with face-fit efficacy in a separate module
upon completion of the necessary research.

B. Powered Air-purifying Particulate Respirators

The proposed regulation included filter efficiency requirements for
powered air-purifying respirators (PAPRs). The solid and liquid and
solid categories were to be tested with sodium chloride (NaCl) and
dioctyl phthalate (DOP), respectively. The classes to be certified were
the 99.97 and 99% efficiency levels. The remaining design and test
parameters for PAPRs were retained from part 11 without change.
Commenters questioned why the efficiency levels proposed for PAPRs
were not the same as non-powered respirators. The proposal specified
three efficiency levels for non-powered (95, 99, 99.97) and only two
levels for PAPRs (99 and 99.97). Commenters indicated many present
filter cartridges are interchangeable between the non-powered and PAPR
units, recommending corresponding filter efficiencies between the non-
powered and PAPR units to retain this broader market for a filter
design.
Numerous commenters stated a concern that the proposed requirements
of subpart K did not adequately address PAPRs. These commenters
indicated that the respiratory protection provided by PAPRs is
dependent on the respirator components working together as a system.
The proposed rule, focusing on filter efficiency, did not address the
system requirements for these respirators. These commenters reasoned
that the performance of these complicated respirator systems deserves
special consideration because of unique problems addressing airflow,
filter efficiency, and fit. These commenters suggested that the
requirements for powered units be removed from subpart K, to be
addressed in a separate module.
Other commenters addressing PAPR requirements stated concerns over
sodium chloride (NaCl) filter test instrumentation capabilities. With
the present state-of-the-art capabilities, the proposed PAPR loading
requirements are difficult to achieve. This leads to a number of
testing difficulties including instrumentation availability, time
consuming tests, reproducibility of results, and system costs. NIOSH
agrees with these concerns and will address them in the forthcoming
module.
Commenters to the proposal also acknowledged that the resultant
part 84 filters would be a significant improvement over those currently
certified and marketed under part 11. Two commenters recognized the
concern over the performance of part 11 powered dust, fume, mist
respirators. They indicated that this concern could be addressed by
incorporating only part 11 high-efficiency filter requirements for
PAPRs approved under part 84. NIOSH agrees and has revised the rule to
permit the continued use of part 11 high efficiency filters for PAPRs
approved under part 84.
NIOSH also agrees with commenters that the proposed filter
efficiency requirements alone do not adequately address the operational
parameters of PAPRs that should be revised. The sections of subpart K
have therefore been modified to be applicable only to non-powered air-
purifying particulate respirators. The requirements for the powered
units will be addressed in a forthcoming module. In the interim,
powered air-purifying particulate respirators equipped with HEPA
filters will be approved under the provisions of subpart KK.

C. Filter Classification

The proposal provided for six classes of filters in a filter
classification system with three filter efficiency levels and two
categories of filter degradation resistance. The three efficiency
levels (99.97, 99, and 95%) were determined by testing with the most
penetrating aerosol size until a maximum loading of 200 mg was reached.
The two degradation resistance categories were established by the
choice of either NaCl or DOP as the test challenge aerosol. Sodium
Chloride is only mildly degrading to filter media while DOP is a liquid
oil that is highly degrading. Accordingly, filters tested with the NaCl
aerosol were recognized as not highly resistant to degradation and only
appropriate for use with solid aerosols in the workplace. Filters
tested with the liquid DOP oil were recognized as highly resistant to
degradation and considered appropriate for both liquid and solid
workplace aerosols.
The categories and classes of filters that would have been
certified under the proposal are summarized below:

------------------------------------------------------------------------
Test
Category Class Efficiency agent
------------------------------------------------------------------------
Solid and liquid.......................... A 99.97 DOP
[[Page 30342]]

Solid..................................... A 99.97 NaCl
Solid and liquid.......................... B 99 DOP
Solid..................................... B 99 NaCl
Solid and liquid.......................... C 95 DOP
Solid..................................... C 95 NaCl
------------------------------------------------------------------------

The behavior of filters to challenge by each of the two test
aerosols depends on the filter type. Mechanical filters and
electrostatic filters are the two fundamental types of particulate
filters on the market. Mechanical filters' efficiencies are determined
by mechanical features such as the diameter, orientation, and
arrangement of the fibers that comprise the filter. Electrostatic
filters have a static electric charge on the filter fibers to enhance
the attraction and retention of the aerosolized particles. The enhanced
efficiency due to the electrical charge means that an electrostatic
filter generally offers lower breathing resistance than a mechanical
filter with the same initial efficiency. This occurs because fewer
fibers are needed in the electrostatic filter to achieve the same level
of efficiency as a mechanical filter. However, the efficiency of
electrostatic filters can be significantly reduced by exposure to
certain aerosols while mechanical filters are generally more resistant
to degradation.
Comments concerning resistance of filters to degradation were
generally of two conflicting schools of thought. One school favored
replacing the two proposed tests with a single, more severe test. The
other favored retaining the two proposed tests at the same or reduced
level of severity.
Commenters opposing the proposed classification system stated it
was not a severe enough test of resistance to filter degradation
because it did not represent a worst-case test. They recommended
testing all filters with a DOP aerosol with the test continued until
there was no further decrease in filter efficiency. Those supporting
this position argued that the proposed filter classification system
could result in overexposure of workers as workplace aerosols degrade
some filters to a level below the certified efficiency level. It was
indicated that various workplace contaminants can cause the beneficial
filtering effects of the charge on electrostatic filters to become
partially or totally ineffective without indication to the wearer. As
the electrostatic charge on the filter fibers is masked by the
deposition of aerosol, the efficiency of the filter can be reduced to
below the anticipated level of protection, based on the certified
efficiency level. Further, these contaminants have been identified as
solids as well as liquids. With no warning to alert the wearer of a
decrease in the performance level of the filter, these commenters
believed that the proposed tests to determine filter efficiency should
be modified to assure that the filters are tested until the minimum
level of efficiency is achieved. The stated advantage of such an
approach is that filters could be used with any aerosol for indefinite
time periods without concern of filter degradation.
The other school argued that the two proposed categories were
either appropriate or too severe. They suggested continuing with the
two categories either as proposed or with a reduction in the amount of
filter loading (to reduce the severity of the test). They argued that
the two proposed filter tests, being a combination of worst-case and
severe test parameters, would assure adequate filter performance in the
workplace.
Several commenters stated that the great majority of respirator
applications are in worksites with aerosols that do not significantly
diminish the efficiency level of the electrostatic filters. Workplace
studies were submitted to support the conclusion that, because of the
highly degrading nature of DOP and the proposed high loading level, the
proposed test were many times more severe than conditions realistically
encountered by workers. These commenters recommended, not only the
certification of two categories as proposed, but that the proposed test
loading levels for both the NaCl and DOP aerosols be reduced to more
closely simulate workplace exposures.
The advantage of the proposed tests was the benefit of potentially
lower breathing resistance, with the resulting increased comfort, of
electrostatic filters for the great majority of respirator wearers who
are not exposed to highly degrading workplace aerosols. Further, the
electrostatic filter types were reported by commenters to have a
potentially lower cost than their mechanical filter counterparts.
This final rule provides for the needs of both the majority workers
with no need for filters highly resistant to degradation and workers
needing filters most resistant to degradation. To that end, this rule
provides for a third category of filters added to the two categories
provided for in the proposal. The new filter category is tested with
the highly degrading DOP until no further decrease in filter efficiency
is observed.
As discussed under VI. Discussion of Final Rule, D. Section-by-
Section Discussion, Sec. 84.170, NIOSH is introducing a new terminology
for the three filter categories. The solid only filters in the proposal
are labeled N-series filters in this final rule. The proposal's solid
or liquid filters are now labeled R-series filters. Filters of the new,
third category are labeled P-series filters. The three categories,
therefore, provide filters for a complete range of applications.
Further, to address concerns about the use of A, B, and C in the
proposal to indicate the efficiency level, the final rule uses
numerical notations of 100, 99, or 95 to indicate filter efficiency.
The rationale for retaining the proposed efficiency levels of 99.97,
99, and 95% is discussed in VI. Discussion of Final Rule, D. Section-
by-Section Discussion, Sec. 84.170(c)(3). The terminology of this final
rule is related to that of the proposal as follows:

------------------------------------------------------------------------
Final Proposal
------------------------------------------------------------------------
N100.......................... Solid only/type A.
N99........................... Solid only/type B.
N95........................... Solid only/type C.
R100.......................... Solid & Liquid/type A.
R99........................... Solid & Liquid/type B.
R95........................... Solid & Liquid/type C.
P100.......................... (Not included in proposal).
P99........................... (Not included in proposal).
P95........................... (Not included in proposal).
------------------------------------------------------------------------

As stated in the proposal, NIOSH selected the test criteria to be a
combination of worst-case and very severe test conditions. The N- and
R-series filters will be tested to a specified maximum loading level as
in the proposal. Performance of these two filter classes at loadings
beyond that maximum will not be evaluated. Furthermore, NIOSH is aware
that few data are available to assess the performance of these
respirators in workplace settings over an extended period of time.
Therefore, the N- and R-series filters will be certified with the
recognition that in some settings time-use limitations should be
applied. A single shift limitation, for example, may be appropriate to
guard against possible degradation of performance below the efficiency
certified by NIOSH. In addition to possible time-use restrictions, the
N-series filters should be restricted to use in those workplaces free
of oil aerosols because the N-series certification tests will involve
challenge with non-degrading sodium chloride aerosols. The R-series
filters should require no such aerosol-use restrictions because R-
series certification tests will involve challenge with highly degrading
dioctylphthalate aerosols. Because the P-series certification tests
will involve challenge with this highly degrading
[[Page 30343]] aerosol that will continue until the filter efficiency
declines to its lowest level, the P-series may require neither aerosol-
use nor time-use limitations. As for any filter, service time will be
limited by considerations of hygiene and increased breathing resistance
due to filter loading.
Guidelines for the use and selection of part 84 particulate
respirators, as described in V. Administrative and Procedural Matters
of Final Rule, B. User's Guide, are to be developed with public input.
The user's guide will include detailed guidance concerning use
limitations for these three filter series.

D. Section-by-Section Discussion.

All sections redesignated to 42 CFR part 84 without modification
from 30 CFR part 11 are excluded in this discussion of the final rule.
The sections redesignated without modification will be revised, where
appropriate, to:
(1) remove references to MSHA, except for those related to certain
mining applications,
(2) update the NIOSH certifying organization to the Certification
and Quality Assurance Branch, Division of Safety Research, NIOSH, 1095
Willowdale Road, Morgantown, West Virginia 26505-2888,
(3) remove references to subpart M, pesticide respirators, and
tests for protection during abrasive blasting,
(4) correct nonsubstantive typographical errors and reference the
new part 84 section designations, and
(5) update references to incorporation-by-reference documents.
The sections redesignated without modification are as follows:
84.1, 84.11, 84.12, 84.21, 84.22, 84.30, 84.31, 84.32, 84.34,
84.35, 84.36, 84.40, 84.41, 84.42, 84.43, 84.50, 84.51, 84.53, 84.60,
84.62, 84.63, 84.64, 84.65, 84.66, 84.70, 84.71, 84.72, 84.73, 84.74,
84.75, 84.76, 84.77, 84.78, 84.79, 84.80, 84.81, 84.82, 84.83, 84.84,
84.85, 84.86, 84.87, 84.88, 84.89, 84.90, 84.91, 84.92, 84.93, 84.94,
84.95, 84.96, 84.97, 84.98, 84.99, 84.100, 84.101, 84.102, 84.103,
84.104, 84.110, 84.111, 84.112, 84.113, 84.114, 84.115, 84.116, 84.117,
84.118, 84.119, 84.120, 84.121, 84.122, 84.123, 84.124, 84.126, 84.130,
84.131, 84.132, 84.133, 84.134, 84.135, 84.136, 84.137, 84.138, 84.139,
84.140, 84.141, 84.142, 84.143, 84.144, 84.145, 84.146, 84.147, 84.148,
84.149, 84.150, 84.151, 84.152, 84.153, 84.154, 84.155, 84.156, 84.157,
84.158, 84.159, 84.160, 84.161, 84.162, 84.163, 84.172, 84.173, 84.174,
84.175, 84.176, 84.178, 84.182, 84.190, 84.191, 84.192, 84.193, 84.194,
84.195, 84.196, 84.197, 84.198, 84.199, 84.200, 84.201, 84.202, 84.204,
84.205, 84.207, 84.250, 84.251, 84.252, 84.253, 84.254, 84.255, 84.256,
84.257, and 84.258.
The following section-by-section analysis discusses each new or
revised section to 42 CFR part 84. All part and section references for
part 11 are to Title 30 of the Code of Federal Regulations (30 CFR).
All part and section references for part 84 are to Title 42 of the Code
of Federal Regulations (42 CFR).

Subpart A--General Provisions

Section 84.2--Definitions

This section is redesignated and revised from Sec. 11.3. This
section is unmodified from the proposal.
The existing definitions for air contamination level, Bureau,
concentration limits for radionuclides, DOP, MESA, pesticide,
radionuclides, and smoke are deleted. These terms are used in
provisions that are modified or deleted as a result of the filter
penetration test changes included in this final rule. These definitions
have, therefore, become unnecessary.
The existing definition for Testing and Certification Laboratory is
modified to reflect the present name of the organization as the
Certification and Quality Assurance Branch. One commenter suggested the
definition of respirator be modified to require a respirator to have
one-way airflow with inspiratory and expiratory valves, able to be
properly positive and negative fit-checked under usual working
conditions. Additionally, this commenter recommended adding a
definition for mask as any device that protects the wearer against
inhalation of a hazardous atmosphere.
The primary purpose of a respirator is to provide respiratory
protection for the wearer. Neither requiring inhalation and exhalation
valves nor reclassifying respirators as masks would enhance worker
protection. Thus NIOSH retained the current definition.

Section 84.3 Respirators For Mine Rescue or Other Emergency Use In
Mines

This section is new and maintains MSHA's role in the approval of
respirators designed for mine rescue or other mine emergency use. This
section is unmodified from the proposal. Under this provision, MSHA and
NIOSH will conduct joint review and certification of respirators used
for mine emergencies and mine rescue. This provision recognizes MSHA's
expertise in identifying the special needs and considerations for
respirators used in the mining environment. This role replaces MSHA's
existing role as a joint approver of all respirators. Several
commenters, while endorsing the transfer of the authority for the
regulation, recognized MSHA's unique expertise relating to mine-
specific respiratory protective devices. These commenters strongly
supported MSHA's continued close involvement in this equipment
including, but is not limited to, filter self-rescuers, self-contained
self-rescuers, and emergency rescue equipment.
Paragraph (a) specifies that NIOSH and MSHA will jointly certify
any respirator designed for mine emergencies, mine rescue or other
emergency use in mines. This joint review and certification includes
any associated service-life plans, user's manuals, and other supporting
documentation. This paragraph further specifies that certifications for
these respirators include any identified use limitations related to
mine safety and health as a condition of certification.
Paragraph (b) specifies NIOSH and MSHA will jointly address recall
and retrofit matters arising from field complaints or identified
deficiencies concerning any respirators used in the mining environment.
A new Memorandum of Understanding is to further delineate MSHA's role
in such matters, including participation in any related field or
manufacturing site audits.

Subpart B--Application for Approval

Section 84.10 Application Procedures

This section is redesignated from existing Sec. 11.10 with only
paragraph (e) modified. This section is unmodified from the proposal.
Paragraph (e) retains the existing requirement for inspection,
examination, and testing by MSHA of electrical and electronic
components to be permissible in accordance with 30 CFR part 18 for
respirators intended for use in mining environments and having
permissible electrical or electronic components. MSHA will continue to
conduct this testing and issue a separate MSHA approval number for
those respirators found acceptable. The process for conducting the
permissibility evaluation of these components and their identification
remains unchanged from the existing policies and practices.

Subpart C--Fees

Section 84.20 Examination, Inspection, and Testing of Complete
Respirator Assemblies; Fees

This section is redesignated from existing Sec. 11.20, and modified
only to reflect the new particulate filter classification scheme. This
section is unmodified from the proposal. [[Page 30344]]

Subpart D--Approval and Disapproval

Section 84.33 Approval Labels and Markings; Approval of Contents; Use

This section is redesignated from existing Sec. 11.33. This section
is unmodified from the proposal.
Paragraph (b) specifies the use of the NIOSH emblem on the approval
label, replacing the MSHA emblem.
Paragraph (e) of this section is modified to identify the existing
dust, fume, and mist class of respirator as a particulate respirator.
The new designation is consistent with the testing criteria under which
these respirators are certified. The table in paragraph (e) identifying
the approval label requirements is modified by the removal of
references specific to paint spray and pesticide respirators, also
consistent with the changes associated with the non-powered air-
purifying particulate filter efficiency level determination test.
Subpart F--Classification of Approved Respirators; Scope of Approval;
Atmospheric Hazards; Service Time

Section 84.52 Respiratory Hazards; Classification

This section is redesignated from existing Sec. 11.52. This section
is unmodified from the proposal.
It is modified only to delete paragraph (d). Reference to the
pesticide classification is no longer appropriate with the introduction
of the particulates classification.

Subpart G--General Construction and Performance Requirements

Section 84.61 General Construction Requirements
This section is redesignated from Sec. 11.61. This section is
unmodified from the proposal.
The provision for respirator components to meet the permissibility
requirements of 30 CFR part 18 [paragraph (e)] has been deleted because
MSHA's workplace regulations separately and independently establish
this requirement for certain mining applications. This change is
consistent with existing practice, whereby, MSHA conducts the
evaluation and testing of these components and issues a separate
approval to cover this aspect of respirator design.

Subpart I--Gas Masks

Section 84.125 Particulate Tests; Canisters Containing Particulate
Filters; Minimum Requirements.

This section is redesignated from existing Sec. 11.102-4, without
modification except to specify the new requirements that respirators
for protection against particulates (dusts, fumes, mists, and smokes)
in combination with gases, vapors, or gases and vapors, must meet.
Except for reference to the redesignated section numbers of subpart K,
this section is unmodified from the proposal. With the exception of the
airflow resistance test of Sec. 84.181, these respirators are required
to meet the requirements specified in Secs. 84.170 through 84.183.

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

Section 84.170 Non-Powered Air-Purifying Particulate Respirators;
Description

This section, derived from Sec. 11.130, is revised to define non-
powered air-purifying particulate respirators in a more concise way
than previously provided for respirators designed for protection
against dusts, fumes, mists, paint sprays, and pesticides. An essential
benefit to filter-mask purchasers of new certifications under this part
is that they will no longer have to be knowledgeable about the
contaminant particle sizes. Under the provisions of this part, NIOSH
will certify filter performance with a test aerosol size chosen so that
filter performance for essentially all other aerosol sizes will be
higher than that certified by NIOSH.
Paragraph (a) describes non-powered air-purifying particulate
respirators as those with air drawn through the air purifying filter as
a result of the negative pressure generated with the inhalation of the
wearer. Non-powered respirators include respirators that depend solely
on the inhalation and exhalation of the wearer to provide an adequate
supply of purified breathing air to the wearer. These respirators are
designed with filters to provide respiratory protection against
atmospheres that contain adequate oxygen to support life and are
contaminated with particulates not immediately dangerous to life or
health. Particulates for which these respirators provide protection
include contaminants such as dusts, fumes, mists and smoke.
Paragraph (b) establishes three series of non-powered air-purifying
particulate respirators designated as N-series, R-series, and P-series.
The N-series respirators are intended for use in those workplaces free
of oil aerosols. The R-series and P-series respirators are intended for
removal of any particulate that includes oil-based liquid particulates.
Paragraph (c) establishes the classification of non-powered air-
purifying particulate respirators according to the efficiency level of
the filter(s) when tested to the requirements of part 84.
Paragraph (c)(1) requires N100, R100, and P100 filters to
demonstrate a minimum efficiency level of 99.97 percent.
Paragraph (c)(2) requires N99, R99, and P99 filters to demonstrate
a minimum efficiency level of 99 percent.
Paragraph (c)(3) requires N95, R95, and P95 filters to demonstrate
a minimum efficiency level of 95 percent.
As discussed previously, some commenters supported the two-
classification system that was proposed while others stated only one
class was needed. NIOSH agrees with commenters that a class of
respirators should be available for use in environments where the
filter efficiency level is not diminished by the worksite aerosol (N-
series). Insufficient studies have been conducted to definitively
characterize workplace aerosols and their effect upon filter
efficiencies. Therefore, NIOSH will certify the new filter categories
recognizing potential aerosol-use and time-use limitations as discussed
above and in VI. Discussion of Final Rule, C. Filter Classification.
Many commenters expressed concerns of confusion in the selection of
the proposed new particulate respirators. Various commenters pointed to
the proposed multiple (two) classes, class nomenclatures (Solid Only
and Liquid and Solid), type nomenclature (A, B, and C), and filter
color requirements as sources for this confusion.
Several commenters recommended that the designations (A, B, and C)
for the types be changed to eliminate confusion of the particulate
respirator classes with other approved respirator types. Some of these
commenters suggested nomenclatures similar to P3, P2, and P1 used for
particulate filters in the European community. Another of these
commenters recommended a further delineation of the alphabetic notation
with each type and class designated by a unique letter (A, B, C, D, E,
and F) for clarification. Still another commenter suggested that the
nomenclatures be changed but made no specific suggestion.
To address concerns about confusion in the selection of respirators
under part 84, NIOSH has developed new category classifications and
will develop a user's guide, as discussed in V. Administrative and
Procedural Matters of Final Rule, B. User's Guide.
Numerous comments were also received regarding the proposed
efficiency levels. Many commenters [[Page 30345]] supported the three
efficiency levels as proposed, while others suggested levels different
than proposed. A 90% filter efficiency level was the most frequently
recommended alternative, sometimes suggested as a fourth class.
NIOSH recognizes that the efficiency requirements contained in the
proposed rule are to some extent technology-forcing. However, HEPA-
level respirators that perform at an efficiency level proposed under
part 84 have been available for years. One commenter (a manufacturer)
stated that the technology for producing 95% (Class C) efficiency level
respirator is practical, reasonable, and available. This commenter
further stated that a Class C respirator could be marketed at a price
not exceeding the price of a 30 CFR part 11 disposable DFM respirator.
The principal advantage of a 90% efficiency class would be to
permit a larger percentage of filters certified under part 11 to be
certified without modification under the new part 84 tests. The best
performing of the current DM and DFM respirators are expected to meet
the requirements of a 95% class, but a significant number of DM
respirators would not be expected to meet the requirements even of a
90% class. Limiting the minimum filter efficiency to 95% will minimize
worker exposure to airborne contaminants from filter penetration. This
is important because it is the most controllable element of protection
afforded by respiratory protection programs. The human variables in
these programs are more difficult to guarantee: that workers are
provided the appropriate class of respirator; that the workers are
effectively fit tested; that they achieve and maintain an effective
face seal each time they wear a respirator; and that they replace
disposable respirators and filters before their effectiveness is
diminished. Some commenters urged, for these reasons, that all filters
should have greater than 99% efficiency. Such high filter efficiency
poses technologic challenges, increases costs to manufacturers and
users, and increases breathing difficulty for respirator wearers. NIOSH
believes that a 95% minimum efficiency best balances the public health
concern and these competing considerations.
Although a number of manufacturers have indicated they are prepared
now to submit filters for certification under these new test
procedures, there may be some who are not. These manufacturers will
have three years to develop this capacity while they continue to market
their existing products.

Section 84.171 Non-powered Air-purifying Particulate Respirators;
Required Components

This section is redesignated from existing Sec. 11.131, modified
only to incorporate the new terminology of particulates to describe
dusts, fumes and mists. This section is unmodified from the proposal,
except for the title change.

Section 84.177 Inhalation and Exhalation Valves; Minimum Requirements

This section is redesignated from existing Sec. 11.137, modified
only to delete reference to the silica dust tests for single-use
respirators of Sec. 11.140-5. This section is unmodified from the
proposal. The respirator performance requirements of these tests are
replaced by the non-powered air-purifying particulate filter efficiency
level determination test contained in this rule.

Section 84.179 Non-powered Air-purifying Particulate Respirators;
Filter Identification

This section requires the identification of non-powered air-
purifying particulate respirators by labeling with a new classification
system for the series and efficiency of the filters. The new
terminology of non-powered air-purifying particulate respirator
replaces the existing dust, fume, and mist respirator, as discussed
previously.
The requirement for the manufacturer to specify the filter-series
and efficiency level classification in the certification application is
contained in paragraph (a). This classification would include the
series of the filter and the expected efficiency of the filter based on
the test requirements specified in Sec. 84.182.
The information to be included on the label of a filter for a
certified non-powered air-purifying particulate respirator is specified
in paragraphs (b)(1) through (b)(9). This labeling defines the
efficiency level achieved in the performance testing (i.e., 99.97%,
99%, or 95%) and the series of the filter (i.e., N, R, or P). This
information is necessary to allow the user to make an informed decision
on selecting the appropriate respiratory protection.
To facilitate this selection process, the P100 filters are color
coded magenta to allow them to be easily distinguished from the other
filter types. The filters other than the P100 can be of any color
except magenta. This color coding is consistent with the present
universally accepted color code convention which identifies the best
performing filters (HEPAs) by their magenta color.
NIOSH has modified these labeling requirements from the proposal in
agreement with the commenters who stated that the labelling should
clearly state the certified efficiency rating numerically and include
the series on the filter, filter package, or respirator box.
One commenter suggested that all classes of certified respirators
should be color coded for user identification; another stated that the
high efficiency filters of each series should be magenta. It was also
requested that color coding as well as letter designation be specified
for all respirators. A more complex color-coding system may add
confusion to the respirator selection process. With the more
descriptive classification identifying labels required by this final
rule, the potential for confusion in selection of the appropriate
respirator has been reduced. Therefore, NIOSH has not adopted these
suggestions.

Section 84.180 Airflow Resistance Tests

Section 84.180 is derived from Sec. 11.140-9. It is modified to
delete the final inhalation resistance requirements. The non-powered
air-purifying particulate filter efficiency level determination tests
are not designed to simulate loading of the filter at the worksite.
Therefore, these requirements are not appropriate with the introduction
of these new tests.
Paragraph (a) provides for determining the inhalation-resistance of
the complete non-powered air-purifying particulate respirator. This
value corresponds to the pressure drop across the complete respirator
mounted on a test fixture with air drawn inward through it at a
continuous rate of 852 liters per minute. Tolerance limits
have been added to the test flow rates as suggested by commenters.
The final rule does not include final breathing resistance limits
as requested in some comments. The final breathing resistances
previously included in the 30 CFR part 11 requirements were based on
filters loading and clogging with a silica dust. The loading
experienced at actual worksites is not represented by such a test. The
inclusion of final breathing resistances as part of a certification
would primarily address two concerns. The first is that the breathing
resistance does not exceed physiological limits or pose undue
discomfort on the wearer. Wearers will replace filters before breathing
resistances reach such levels. The second concern is that the filter
efficiency is still at an acceptable level at the certification final
resistance value. The filter efficiency level determination
[[Page 30346]] and respirator classifications provided for in this rule
are sufficiently severe to alleviate this concern.
One commenter questioned NIOSH's intent for restricting final
inhalation resistance for particulate filters used in conjunction with
chemical cartridges. This commenter pointed to Sec. 84.203 requirements
which specify maximum allowable final inhalation resistances for these
combinations. The final inhalation value is to be measured at the end
of the service life tests for the chemical cartridge portion of the
combination. NIOSH will continue to measure the initial and final
inhalation and exhalation resistances of the combination in conjunction
with the service life test of the chemical cartridge. The inhalation
and exhalation resistances need not be measured for these combinations
in conjunction with the particulate efficiency level determination
tests.
Paragraph (b) states the inhalation resistance of the complete
respirator is not to exceed 35 millimeters of water-column height. The
exhalation resistance of the complete respirator is not to exceed 25
millimeters of water-column height.
The proposed rule would have limited the inhalation and exhalation
resistances to 30 and 20 millimeters of water-column height,
respectively. Several commenters requested that the values be
increased. Increased breathing resistance values will permit the
effective use of presently available filter material in respirators re-
designed to meet the efficiency level determination tests at a
reasonable cost. Others expressed a concern that respirators with
higher breathing resistances are less likely to be fitted properly,
often intentionally due to the discomfort. Commenters expressed that
this may be true in the health-care profession where the use of
certified respirators is new.
The final rule has increased the maximum acceptable breathing
resistance values slightly from the proposed levels to those suggested
by commenters. The proposed resistance levels of 30 and 20 millimeters
of water-column height corresponded to the maximum allowable resistance
values in part 11 for any particulate respirator. The new resistance
levels remain below the acceptable limits for some non-particulate
respirator classes under the existing part 11 provision. For example,
chemical cartridge respirators, which have use patterns similar to
particulate filter respirators, have a maximum initial inhalation
resistance of 40 millimeters water-column height. This increase in
acceptable breathing resistance for particulate respirators will enable
manufacturers to produce respirators meeting the new requirements more
expeditiously and at lower cost than the proposal would have allowed.
This small increase in maximum allowable breathing resistance for
particulate respirators does not add substantially to physiologic
burden for respirator users, and will be compensated by increased
worker protection provided by the new filter efficiency tests and
classification system. The acceptable breathing resistance levels for
the non-particulate respirator classes are not affected.

Section 84.181 Non-powered Air-Purifying Particulate Filter Efficiency
Level Determination

This section is new and specifies the test criteria and acceptable
performance criteria for the new non-powered air-purifying particulate
filter efficiency level determination. This section has been retitled
from particulate instantaneous-penetration-filter test in response to a
comment. The new title more appropriately represents the intent of the
tests in this section to determine the efficiency level of the filters.
Paragraph (a) requires the filter efficiency testing of 20 filters
of each non-powered air-purifying particulate respirator model. Testing
is conducted using a solid sodium chloride or equivalent particulate
aerosol for N-series certification or a dioctyl phthalate or equivalent
liquid particulate aerosol for R-series and P-series certification.
Paragraph (b) requires the filters, including holders and gaskets;
when separable, to be tested mounted on a test fixture in the manner as
used on the respirator. This provides for testing of the assembly in a
configuration as it will be actually used.
Paragraph (c) describes preconditioning requirements for the 20 N-
series filters to be tested. After removal from their packaging, the 20
filters are placed in an environment of 855 percent
relative humidity at 382.5 deg.C for 251
hours. The filters shall be stored in a gas-tight container until
tested. Testing for the filter efficiencies must be performed within 10
hours following preconditioning. These preconditioning requirements
apply only to N-series filters differing from the proposal which would
have had filters of each series subjected to preconditioning.
Paragraph (d) provides for blocking the exhalation valves to ensure
that any valve leakage is not included in the filter efficiency level
evaluation. This only applies when the filters do not have separable
holders and gaskets.
Paragraph (e) specifies the continuous test aerosol flow rates for
the filter efficiency testing. Single filters are tested at a rate of
854 liters per minute; filters used in pairs are tested at
a rate of 42.5 2 liters per minute through each filter.
Paragraph (f) describes the penetration test aerosols and the test
criteria to be used. A sodium chloride or equivalent solid aerosol is
used when testing for filter efficiency for N-series filters. A
neutralized-dioctyl phthalate (DOP), or equivalent oil, liquid aerosol
is specified as the testing agent when testing for filter efficiency of
R- and P-series filters. For P-series filters, the filter efficiency
test will be continued until minimum efficiency is obtained. However,
for N- and R-series respirators it will be terminated when an aerosol
mass of 2005 mg has contacted the filter unit, if minimum
efficiency has not been obtained.
Paragraph (f)(1) identifies the test conditions for the sodium
chloride or equivalent solid aerosol to be at 255 deg.C
and relative humidity of 3010 percent. The aerosol
specified to be used in these tests will be neutralized to the
Boltzmann equilibrium state, and the maximum concentration will not
exceed 200 mg/m\3\. The relative humidity of the sodium chloride
aerosol has been changed from the proposal in response to a comment.
This change, a small increase in the relative humidity of the aerosol,
allows testing at the values normally encountered with the test
instruments commonly used.
Paragraph (f)(2) specifies the DOP or equivalent oil liquid
particulate aerosol. The test conditions for the liquid aerosol are
specified to be at 255 deg.C. The aerosol specified to be
used in these tests will be neutralized to the Boltzmann equilibrium
state, and the maximum concentration will not exceed 200 mg/m\3\.
Paragraph (g) specifies the particle size limitations at the test
conditions for the filter efficiency test aerosols. The sodium chloride
aerosol will have a particle size distribution with count median
diameter between 0.0750.020 micrometer and a standard
geometric deviation not exceeding 1.86. The liquid particulate aerosol
has a particle size distribution with count median diameter between
0.1850.020 micrometer and a standard geometric deviation
not exceeding 1.60. NIOSH will make these particle size distribution
determinations at the specified test conditions with a scanning
mobility particle sizer (SMPS) or equivalent. The specification of a
scanning mobility particle sizer represents newer technology than the
[[Page 30347]] differential mobility particle sizer that was specified
in the proposal. This reference to the newer technology was added in
response to comments from the public. NIOSH will accept manufacturer's
size verification data determined by SPMS or an equivalent particle
sizing instrument that provides particle sizing information consistent
with an SPMS.
Paragraph (h) requires the efficiency of the filter (i.e., the
amount of aerosol particles that pass through the filter) to be
monitored and recorded throughout the test period by a suitable
forward-light-scattering photometer or equivalent instrumentation.
Paragraph (i) requires the minimum filter efficiency for each of
the 20 filters to be determined and recorded. The minimum efficiency of
each tested filter is to be greater than or equal to 99.97% for P100,
R100 and N100 filters; 99% for P99, R99 and N99 filters; and 95% for
P95, R95 and N95 filters.
Many comments were received on all aspects of the testing
requirements. Comments were received regarding the proposed loading
levels, test agents, preconditioning requirements, number of filters to
be tested, and test equipment specifications.
The proposal included a statistical treatment of the filter
efficiency test results (U statistic). Thirty filter samples were to be
tested for each certification application. The number of samples tested
and the test statistic used in the treatment of the data was intended
to provide a 95% confidence interval of 95% conformance (95% tolerance
interval) of manufacturers' product to the certification criterion.
These methods rely on the applicability of the ``normal'' or Gaussian
distribution for test data. A similar statistical treatment of the test
data was included in the 1987 NIOSH proposal.
A number of commenters expressed concern with the use of a NIOSH
proposed U statistic (based on a 95% tolerance interval for the 95th
percentile) to determine if the performance of filters submitted by
manufacturers meet the requirements for requested classification
(type). Comments concerned the use of the constant 2.22 for the
calculation of the U statistic, suggesting that this is too strict a
criterion for manufacturers to meet and implying that 95% tolerance
intervals based on some lower percentile (e.g., 90th) would be more
appropriate. Other comments concerned the distribution assumptions
inherent in the calculation of the U statistic. Commenters expressed
concern that the assumption that test data represent a sample from a
Gaussian distribution is incorrect and that the application of
tolerance interval methods for this data is inappropriate.
Other commenters questioned NIOSH's justification to ``knowingly''
allow the certification of respirators that do not meet the performance
requirements. They interpreted the statistical criterion as NIOSH
accepting up to 5% of the distributed respirators to be less than the
stated class minimum. This analysis of the data would imply that some
of the distributed certified respirators perform below the inferred
minimum performance level of its class. The commenters expressed
concern that this would cause an unacceptably large number of workers
to have inadequate respirator protection.
One commenter pointed out that the use of the U statistic was an
attempt to predict future production variability. This commenter
further asserted that respirators submitted for certification testing
do not constitute a random sample of a manufacturer's product.
Production variability, this commenter continued, is to be controlled
by the separate quality control program.
NIOSH concurs with the commenter that the proposed statistical
approach addressing pre-market production samples is inconsistent with
determining product quality in a controlled process. NIOSH further
agrees that the samples submitted for certification testing are not
random samples. Therefore, the final rule does not include an
acceptance criterion based upon the statistical treatment of test data.
A significant portion of the cost attributed to the proposed
regulations (25 to 30% of the cost, by one estimate) resulted from the
statistical treatment of data. Manufacturers stated that this cost
impact would be reduced if a 95% tolerance interval based on a 90
percentile (i.e., 95% confidence of 90% conformance) were used.
Manufacturers and others suggested that a pass/fail criterion should be
offered. Several commenters suggested reducing the number of test
samples and using a pass/fail criterion.
A pass/fail criterion is consistent with the current respirator
acceptance criterion, and is generally accepted as appropriate for a
certification program with testing of pre-production units. The pass/
fail criterion presents another advantage in that it establishes the
minimum acceptable performance level consistent with the class
definition. A member of a 95% class will not be in compliance with the
certification if it has an efficiency below that level when tested. The
statistical test criterion could allow some individual units to have
performance test measurements below 95% but still meet certification
requirements.
Based on these comments, NIOSH has reconsidered the use of the
tolerance interval approach for the analysis of respirator performance
data. NIOSH agrees that the application of the tolerance interval
approach is inconsistent with type approval and recognizes that
respirators submitted for certification do not constitute a random
sample of a manufacturer's product. Consequently, the final rule has
been modified to test 20 respirators for laboratory performance, with
certification if all 20 units meet the specifications.
The proposal specified both sodium chloride (NaCl) as the solid
test aerosol and dioctyl phthalate (DOP) as the liquid test aerosol.
Although DOP is a suspected carcinogen, the set up of the test
instruments precludes laboratory personnel exposure to the aerosol.
Sodium chloride does not pose a suspected health hazard. Dioctyl
phthalate is the most severe liquid, or degrading test aerosol known.
It has been used for decades as the test aerosol for certification of
the best (HEPA) part 11 filters. Sodium chloride is a solid test
aerosol that provides some degrading characteristics. Sodium chloride
has also been used for years as the solid test agent in the European
(CEN) certification standards.
No comments were received against the use of NaCl as the solid test
aerosol for non-powered respirators. One commenter, a former employee
of the Department of Defense, questioned its use because the military
does not use it in their mask testing. Another commenter, accepting the
use of NaCl, stated that part 84 should allow equivalent test aerosols
as well. The only negative comments received to the NaCl test aerosol
were due to the difficulties associated with the testing of powered
air-purifying respirators (PAPRs). The requirements for PAPRs was
discussed previously in V. Discussion of Final Rule, B. Powered Air-
Purifying Particulate Respirators.
Commenters interested in the use of certified respirators for
protection against TB suggested the use of biological agents
(bioaerosols) for the certification testing. It is not necessary to
subject filter respirators to a bioaerosol as a condition of
certification. By using test aerosols of the most penetrating size
range, the efficiency-level determination of the certification testing
will be the lowest obtainable for any size aerosol. Therefore, the
efficiency level against [[Page 30348]] any bioaerosol for any
certified respirator will meet or exceed the certified efficiency
level.
Comments concerning the choice of liquid test aerosols were varied.
Several different test agents were suggested including paraffin oil,
Emery 3004, and hydrofluoric acid. Paraffin oil was suggested because
it is consistent with the European (CEN) standards. The U.S. military
has adopted Emery 3004 as a DOP replacement in instantaneous testing of
filter efficiency. A commenter suggested that because hydrofluoric acid
aerosol is common in many industries, it would be a more realistic test
agent.
Each of the suggested alternative liquid aerosols would provide
essentially the same initial or lightly loaded filter efficiency
levels. The initial efficiency level of a filter is defined primarily
by the particle size of the aerosol, not its degrading ability. The CEN
standards use paraffin oil as the liquid test aerosol, but the filters
are not loaded to a significant level. Emery 3004 has been adopted as a
replacement for DOP by the military in initial efficiency testing as
performed for the part 11 HEPA filters. Unlike DOP, none of the
recommended alternative test aerosols provide severe degrading effects
of the filters. This severity is an integral part of the part 84
testing, and addressing the uncertainties of the effects of actual
workplace aerosols.
In considering these options, NIOSH is aware that no single test
agent is used by every prominent standard-setting agency or
organization. The CEN standard uses NaCl as a solid test aerosol. The
current draft for revising the ANSI Z88.8 standard proposes NaCl and
DOP as the test aerosols. No choice of test aerosol would provide
consistency with all other standards, as sought by commenters. A
fundamental purpose of the new testing standards is to assure that at
least one class of filters is highly resistant to degradation by
workplace aerosols. The DOP aerosol was selected for this purpose
specifically because of its severe effect on filter efficiency level.
The proposed alternatives demonstrate less severe effects on the filter
media; therefore, they have been considered inappropriate for the
evaluation intended by NIOSH.
The generation method of dioctyl phthalate aerosol was a concern to
many commenters. Commenters questioned the particle size distribution
for this test aerosol specified in the proposal being greater than that
specified in the existing part 11 requirements. Commenters also
questioned differences in test results based on the use of thermally
generated (hot) or cold-nebulized DOP aerosol. Although the proposal
did not specify any aerosol generation technique to be used for DOP
testing, much of NIOSH's research used as a basis for the proposal was
performed with cold-nebulized DOP and NIOSH testing has demonstrated
that correlation in results obtained between the two aerosol generation
techniques is possible. Some commenters believed that the DOP aerosol
generation method must be specified to ensure reproducible test
results. These commenters used data from Industrial Safety Equipment
Association-sponsored ``round robin'' testing of mechanical and
electrostatic filter material. Complete data and specifics of the round
robin testing were not provided to NIOSH. These tests were conducted
among the majority of the air-purifying respirator manufacturers that
are ISEA members. The test results indicated excellent correlation
between the two aerosol generation methods for efficiency of
standardized mechanical filter media. For standardized electrostatic
media, a divergence in efficiency with increased filter loading was
reported between the two aerosol generation methods. These commenters
also reported that both the initial and stabilized efficiencies of the
electrostatic media correlated well between the two aerosol generation
methods. The divergence reported appears to be a different degradation
rate between the two aerosols.
Moreover, several of the participants provided some additional
insights into the circumstances of the testing. A significant portion
of the manufacturers had recently acquired the cold-nebulized test
instruments. The reproducibility problems reported, they admitted,
could have resulted from operator inexperience. One of the participants
with extensive experience with both aerosol generation methods related
some of the experience gained by that manufacturer. Excellent
correlation is maintained between this commenter's numerous cold-
nebulized DOP instruments in use world-wide. Also, the commenter
reported having encountered no reproducibility problems between
thermally-generated and cold-nebulized instruments in testing
electrostatic media when new DOP is used.
In NIOSH testing, some tests have provided good correlation of
results between the two aerosol generation methods, while others have
not. DOP changes chemically as it ages, becoming less pure. The
thermal-generation method induces a similar chemical change, simulating
accelerated aging of the DOP. Recent NIOSH testing indicates that the
chemically-changed DOP may cause the test instruments to fluctuate from
the stated testing parameters. If monitored closely, and kept within
the specified parameters, equivalent results are obtained with either
aerosol generation method. Therefore, to accommodate these concerns,
the final rule specifies a test using a neat cold-nebulized DOP test,
or equivalent test. Allowing equivalent test methods permits the use of
tests that respirator manufacturers may have already developed. As part
of the established certification process, NIOSH evaluates the test
results submitted by the applicant by comparing them to the results of
NIOSH testing. Any test method yielding results equivalent to the NIOSH
testing will be acceptable.
To further address the testing reproducibility concerns expressed
by commenters, NIOSH is initiating a program whereby a standard
mechanical and electrostatic filter media sample will be made available
upon request for applicant correlation testing. NIOSH will run
characterization tests on these standardized media and send a data
sheet showing the test results with the samples. NIOSH has
traditionally conducted correlation testing for applicants requesting
such testing to document the agreement of their test instruments and
procedures and those of NIOSH. This new procedure will continue the
service provided to the applicants of assuring that the results they
obtain on their instruments and with their procedures provide results
comparable with NIOSH's certification tests. This new process will
reduce the NIOSH resource requirements for corroborating the test
results of the large number of applicants that NIOSH anticipates will
be requesting this service and expedite the correlation process.
Several comments were received on the humidity preconditioning
requirement for filters. One commenter stated that the proposed
preconditioning time (24 hours) was inadequate to have much of an
effect on the performance of electrostatic filter media. The commenter
suggested a thirty-day preconditioning period. Information provided
regarding the ISEA round-robin testing stated that the effects of the
preconditioning were insignificant when testing with the DOP aerosol.
This assessment agrees with NIOSH testing experience. The other
commenters had concerns that the proposal did not provide: detail
regarding uniform preconditioning, the size of the container, the
allowable time after conditioning at which filter media must be placed
within the container and [[Page 30349]] the allowable time for the
filter to remain within the container until tested.
The final rule has been modified to require only N-series filters
be taken out of their packaging and humidity preconditioned prior to
filter efficiency level testing at 855 percent relative
humidity at 382.5 deg.C for 251 hours. The
final rule states that following the preconditioning, the filters shall
be sealed in a gas-tight container and tested within 10 hours. R- and
P-series filters do not have to be preconditioned because they are
tested against DOP which is much more severe than humidity in regard to
reducing filter efficiency. The preconditioning requirement is retained
for the N-series filters to address the effect of humidity on the
filter's efficiency because the sodium chloride aerosol is less severe
than DOP in reducing filter efficiency. The 10-hour limitation on
storage of the filters before efficiency testing will eliminate the
variability concerns.
The final rule has been modified to specify a scanning mobility
particle sizer (SMPS) or equivalent, as recommended by commenters, to
be consistent with the latest technology. One commenter suggested a
flame photometer be allowed for measurement of sodium chloride. The
same commenter also stated that other sizing devices such as the
Tyndall Owl have been used for years and should be an acceptable
measuring instrument. NIOSH is aware that other instrumentation can
provide sizing information that can equate to the values specified in
the rule. In specifying the particle size, it is important to identify
the technology used in its determination. The differential mobility
particle sizer (DMPS) was specified in the proposed rule because this
is the technology traditionally used by NIOSH to determine the particle
sizes of this test. The use of these other instruments is acceptable
and all other such equipment does not have to be specified in the final
rule. To make size verification measurements manufacturers may use any
particle sizing instrument that provides particle sizing information
consistent with an SPMS.

Subpart L--Chemical Cartridge Respirators

Section 84.203 Breathing Resistance Tests; Minimum Requirements

This section is redesignated from existing Sec. 11.162-1. This
section is unmodified from the proposal.
It is modified only to delete reference to various classifications,
such as paints and pneumoconiosis and fibrous producing dusts, that are
no longer appropriate with the introduction of the particulates
classification with the new instantaneous-penetration test.

Section 84.206 Particulate Tests; Respirators With Filters; Minimum
Requirements; General

This section is redesignated from existing Sec. 11.162-7. This
section is unmodified from the proposal. It is modified only to delete
reference to various classifications, such as paints and pneumoconiosis
and fibrous producing dusts, that are no longer appropriate with the
introduction of the particulates classification with the new
instantaneous-penetration test.

Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray Respirators
and Combination Gas Masks

This subpart has been added to continue the part 11 requirements
for the existing dust, fume, and mist; pesticide; paint spray
respirators and combination gas masks during the transition period to
part 84.
These sections are derived from existing 30 CFR part 11, subpart K.
They are modified to update them to part 84 section numbers.
This subpart also included the upgraded requirements for PAPRs to
include only high efficiency filters (HEPA).

Derivation Table

The following derivation table lists (1) each section number of the
final rule (New Section); and (2) the section number of the existing
standard from which the proposed standard is derived (Old Section).

Derivation Table
------------------------------------------------------------------------
New section Old section
------------------------------------------------------------------------
42 CFR 30 CFR
84.1............................. 11.1
84.2............................. 11.3
84.3............................. 11.4
84.4............................. New.
84.10............................ 11.10
84.11............................ 11.11
84.12............................ 11.12
84.20............................ 11.20
84.21............................ 11.21
84.22............................ 11.22
84.30............................ 11.30
84.31............................ 11.31
84.32............................ 11.32
84.33............................ 11.33
84.34............................ 11.34
84.35............................ 11.35
84.36............................ 11.36
84.40............................ 11.40
84.41............................ 11.41
84.42............................ 11.42
84.43............................ 11.43
84.50............................ 11.50
84.51............................ 11.51
84.52............................ 11.52
84.53............................ 11.53
84.60............................ 11.60
84.61............................ 11.61
84.62............................ 11.62
84.63............................ 11.63
84.64............................ 11.64
84.65............................ 11.65
84.66............................ 11.66
84.70............................ 11.70
84.71............................ 11.71
84.72............................ 11.72
84.73............................ 11.73
84.74............................ 11.74
84.75............................ 11.75
84.76............................ 11.76
84.77............................ 11.77
84.78............................ 11.78
84.79............................ 11.79
84.80............................ 11.79-1
84.81............................ 11.80
84.82............................ 11.81
84.83............................ 11.82
84.84............................ 11.83
84.85............................ 11.84
84.86............................ 11.85-1
84.87............................ 11.85-2
84.88............................ 11.85-3
84.89............................ 11.85-4
84.90............................ 11.85-5
84.91............................ 11.85-6
84.92............................ 11.85-7
84.93............................ 11.85-8
84.94............................ 11.85-9
84.95............................ 11.85-10
84.96............................ 11.85-11
84.97............................ 11.85-12
84.98............................ 11.85-13
84.99............................ 11.85-14
84.100........................... 11.85-15
84.101........................... 11.85-16
84.102........................... 11.85-17
84.103........................... 11.85-18
84.104........................... 11.85-19
84.110........................... 11.90
84.111........................... 11.91
84.112........................... 11.92
84.113........................... 11.93
84.114........................... 11.94
84.115........................... 11.95
84.116........................... 11.96
84.117........................... 11.97
84.118........................... 11.98
84.119........................... 11.99
84.120........................... 11.100
84.121........................... 11.101
84.122........................... 11.102-1
84.123........................... 11.102-2
84.124........................... 11.102-3
84.125........................... 11.102-4
84.126........................... 11.102-5
84.130........................... 11.110
84.131........................... 11.111
84.132........................... 11.112
84.133........................... 11.113
84.134........................... 11.114
84.135........................... 11.115
84.136........................... 11.116
84.137........................... 11.117
84.138........................... 11.118
[[Page 30350]]

84.139........................... 11.119
84.140........................... 11.120
84.141........................... 11.121
84.142........................... 11.122
84.143........................... 11.123
84.144........................... 11.124-1
84.145........................... 11.124-2
84.146........................... 11.124-3
84.147........................... 11.124-4
84.148........................... 11.124-5
84.149........................... 11.124-6
84.150........................... 11.124-7
84.151........................... 11.124-8
84.152........................... 11.124-9
84.153........................... 11.124-10
84.154........................... 11.124-11
84.155........................... 11.124-12
84.156........................... 11.124-13
84.157........................... 11.124-14
84.158........................... 11.124-15
84.159........................... 11.124-16
84.160........................... 11.124-17
84.161........................... 11.124-18
84.162........................... 11.124-19
84.163........................... 11.124-20
84.170........................... 11.130
84.171........................... 11.131
84.172........................... 11.132
84.173........................... 11.133
84.174........................... 11.134
84.175........................... 11.135
84.176........................... 11.136
84.177........................... 11.137
84.178........................... 11.138
84.179........................... New.
84.180........................... 11.140-9
84.181........................... New.
84.182........................... 11.140-10
84.190........................... 11.150
84.191........................... 11.151
84.192........................... 11.152
84.193........................... 11.153
84.194........................... 11.154
84.195........................... 11.155
84.196........................... 11.156
84.197........................... 11.157
84.198........................... 11.158
84.199........................... 11.158-1
84.200........................... 11.159
84.201........................... 11.160
84.202........................... 11.161
84.203........................... 11.162-1
84.204........................... 11.162-2
84.205........................... 11.162-3
84.206........................... 11.162-7
84.207........................... 11.162-8
84.250........................... 11.200
84.251........................... 11.201
84.252........................... 11.202
84.253........................... 11.203
84.254........................... 11.204
84.255........................... 11.205
84.256........................... 11.206
84.257........................... 11.207
84.258........................... 11.208
84.1100.......................... New.
84.1101.......................... 11.3
84.1102.......................... 11.20
84.1103.......................... 11.33
84.1130.......................... 11.102-4, 11.130, 11.170
84.1131.......................... 11.91, 11.131, 11.171
84.1132.......................... 11.95, 11.132, 11.175
84.1133.......................... 11.96, 11.133, 11.176
84.1134.......................... 11.97, 11.134, 11.177
84.1135.......................... 11.98, 11.135, 11.178
84.1136.......................... 11.99, 11.136, 11.179
84.1137.......................... 11.100, 11.137, 11.180
84.1138.......................... 11.101, 11.138, 11.181
84.1139.......................... 11.139, 11.182
84.1140.......................... 11.140
84.1141.......................... 11.140-1
84.1142.......................... 11.140-2
84.1143.......................... 11.140-3
84.1144.......................... 11.140-4
84.1145.......................... 11.140-5
84.1146.......................... 11.140-6
84.1147.......................... 11.140-7
84.1148.......................... 11.140-8
84.1149.......................... 11.140-9
84.1150.......................... 11.140-10
84.1151.......................... 11.140-11
84.1152.......................... 11.140-12
84.1153.......................... 11.102-4
84.1154.......................... 11.172, 11.173
84.1155.......................... 11.174
84.1156.......................... 11.183, 11.183-1, 11.183-3,
11.183-4, 11.183-5, 11.183-6,
11.183-7
84.1157.......................... 11.162, 11.162-1, 11.162-4,
11.162-5, 11.162-6, 11.162-8
84.1158.......................... 11.162-7
------------------------------------------------------------------------

Distribution Table

The following distribution table lists (1) the section number of
the existing part 11 standard (Old Section); and (2) each section
number of the final rule (New Section).

Distribution Table
------------------------------------------------------------------------
Old section New section
------------------------------------------------------------------------
30 CFR 42 CFR
11.1............................. 84.1
11.2............................. Removed.
11.2-1........................... Removed.
11.3............................. 84.2, 84.1101
11.4............................. 84.3
11.10............................ 84.10
11.11............................ 84.11
11.12............................ 84.12
11.20............................ 84.20, 84.1102
11.21............................ 84.21
11.22............................ 84.22
11.30............................ 84.30
11.31............................ 84.31
11.32............................ 84.32
11.33............................ 84.33, 84.1103
11.34............................ 84.34
11.35............................ 84.35
11.36............................ 84.36
11.40............................ 84.40
11.41............................ 84.41
11.42............................ 84.42
11.43............................ 84.43
11.50............................ 84.50
11.51............................ 84.51
11.52............................ 84.52
11.53............................ 84.53
11.60............................ 84.60
11.61............................ 84.61
11.62............................ 84.62
11.63............................ 84.63
11.64............................ 84.64
11.65............................ 84.65
11.66............................ 84.66
11.70............................ 84.70
11.71............................ 84.71
11.72............................ 84.72
11.73............................ 84.73
11.74............................ 84.74
11.75............................ 84.75
11.76............................ 84.76
11.77............................ 84.77
11.78............................ 84.78
11.79............................ 84.79
11.79-1.......................... 84.80
11.80............................ 84.81
11.81............................ 84.82
11.82............................ 84.83
11.83............................ 84.84
11.84............................ 84.85
11.85............................ Removed.
11.85-1.......................... 84.86
11.85-2.......................... 84.87
11.85-3.......................... 84.88
11.85-4.......................... 84.89
11.85-5.......................... 84.90
11.85-6.......................... 84.91
11.85-7.......................... 84.92
11.85-8.......................... 84.93
11.85-9.......................... 84.94
11.85-10......................... 84.95
11.85-11......................... 84.96
11.85-12......................... 84.97
11.85-13......................... 84.98
11.85-14......................... 84.99
11.85-15......................... 84.100
11.85-16......................... 84.101
11.85-17......................... 84.102
11.85-18......................... 84.103
11.85-19......................... 84.104
11.90............................ 84.110
11.91............................ 84.111, 84.1131
11.92............................ 84.112
11.93............................ 84.113
11.94............................ 84.114
11.95............................ 84.115, 84.1132
11.96............................ 84.116, 84.1133
11.97............................ 84.117, 84.1134
11.98............................ 84.118, 84.1135
11.99............................ 84.119, 84.1136
11.100........................... 84.120, 84.1137
11.101........................... 84.121, 84.1138
11.102........................... Removed.
11.102-1......................... 84.122
11.102-2......................... 84.123
11.102-3......................... 84.124
11.102-4......................... 84.125, 84.1130, 84.1153
11.102-5......................... 84.126
[[Page 30351]]

11.110........................... 84.130
11.111........................... 84.131
11.112........................... 84.132
11.113........................... 84.133
11.114........................... 84.134
11.115........................... 84.135
11.116........................... 84.136
11.117........................... 84.137
11.118........................... 84.138
11.119........................... 84.139
11.120........................... 84.140
11.121........................... 84.141
11.122........................... 84.142
11.123........................... 84.143
11.124........................... Removed.
11.124-1......................... 84.144
11.124-2......................... 84.145
11.124-3......................... 84.146
11.124-4......................... 84.147
11.124-5......................... 84.148
11.124-6......................... 84.149
11.124-7......................... 84.150
11.124-8......................... 84.151
11.124-9......................... 84.152
11.124-10........................ 84.153
11.124-11........................ 84.154
11.124-12........................ 84.155
11.124-13........................ 84.156
11.124-14........................ 84.157
11.124-15........................ 84.158
11.124-16........................ 84.159
11.124-17........................ 84.160
11.124-18........................ 84.161
11.124-19........................ 84.162
11.124-20........................ 84.163
11.124-21........................ Removed.
11.124-22........................ Removed.
11.124-23........................ Removed.
11.124-24........................ Removed.
11.130........................... 84.170, 84.1130
11.131........................... 84.171, 84.1131
11.132........................... 84.172, 84.1132
11.133........................... 84.173, 84.1133
11.134........................... 84.174, 84.1134
11.135........................... 84.175, 84.1135
11.136........................... 84.176, 84.1136
11.137........................... 84.177, 84.1137
11.138........................... 84.178, 84.1138
11.139........................... 84.1139
11.140........................... 84.1140
11.140-1......................... 84.1141
11.140-2......................... 84.1142
11.140-3......................... 84.1143
11.140-4......................... 84.1144
11.140-5......................... 84.1145
11.140-6......................... 84.1146
11.140-7......................... 84.1147
11.140-8......................... 84.1148
11.140-9......................... 84.180, 84.1149
11.140-10........................ 84.182, 84.1150
11.140-11........................ 84.1151
11.140-12........................ 84.1152
11.150........................... 84.190
11.151........................... 84.191
11.152........................... 84.192
11.153........................... 84.193
11.154........................... 84.194
11.155........................... 84.195
11.156........................... 84.196
11.157........................... 84.197
11.158........................... 84.198
11.158-1......................... 84.199
11.159........................... 84.200
11.160........................... 84.201
11.161........................... 84.202
11.162........................... 84.1157
11.162-1......................... 84.203, 84.1157
11.162-2......................... 84.204
11.162-3......................... 84.205
11.162-4......................... 84.1157
11.162-5......................... 84.1157
11.162-6......................... 84.1157
11.162-7......................... 84.206, 84.1158
11.162-8......................... 84.207, 84.1157
11.170........................... 84.1130
11.171........................... 84.1131
11.172........................... 84.1154
11.173........................... 84.1154
11.174........................... 84.1155
11.175........................... 84.1132
11.176........................... 84.1133
11.177........................... 84.1134
11.178........................... 84.1135
11.179........................... 84.1136
11.180........................... 84.1137
11.181........................... 84.1138
11.182........................... 84.1139
11.183........................... 84.1156
11.183-1......................... 84.1156
11.183-2......................... Removed.
11.183-3......................... 84.1156
11.183-4......................... 84.1156
11.183-5......................... 84.1156
11.183-6......................... 84.1156
11.183-7......................... 84.1156
11.200........................... 84.250
11.201........................... 84.251
11.202........................... 84.252
11.203........................... 84.253
11.204........................... 84.254
11.205........................... 84.255
11.206........................... 84.256
11.207........................... 84.257
11.208........................... 84.258
------------------------------------------------------------------------

VII. Executive Order 12866 and Regulatory Flexibility Act

Section 1 of Executive Order 12866 requires that before
promulgating a new regulation, an agency must weigh many competing
factors. In particular, the agency must assess the need for the
regulation, identify and assess alternatives, determine whether the
regulation is designed to achieve the agency's objectives in the most
cost-effective manner, and, to the extent feasible, use performance
standards. In addition, Section 5 of the Order requires an assessment
of the burden imposed by existing regulations, to identify those that
have become unjustified or unnecessary as a result of changed
circumstances. The Regulatory Flexibility Act (the Act) also requires
that the agency periodically review existing regulations and consider
reforming those that burden small entities, taking into account the
degree to which technology or other factors have changed in the area
affected by the rule. NIOSH is promulgating these regulatory changes in
compliance with both sections of the Executive Order and the Act.
Dose-response data are inadequate to permit a quantitative
description of the risks that would be faced by American workers if
respirators were not used. Neither are there dose-response data that
can support a quantitative description of the risk reduction that will
be achieved by the revised filter performance standards in 42 CFR part
84. Employers frequently lack the economic means or the technical
expertise to make detailed workplace hazard assessments. For the great
majority of occupational settings, environmental data on the airborne
concentrations of toxic materials are completely lacking. When exposure
data are available, they tend to be limited at best. Consequently, it
is difficult to establish quantitative exposure-response relationships.
Most often, occupational exposure data demonstrate the association
between exposure and response, but do not support a precise exposure-
response curve. Extrapolation from exposure to dose is subject to even
greater uncertainty. The variability in exposure between and within
workplaces, exposures over long working lifetimes, possibly
inconsistent or improper use of respiratory protection, and undetected
episodes of substandard respirator performance, among other factors,
all make it very difficult to determine what a worker's dose may be
even if there are measured exposure levels.
Employers, both large and small, rely upon respirators to protect
their employees from airborne toxic contaminants. The preferred and
most effective means of protecting workers is to prevent hazards
entering their breathing zone in the first place, but it is not
technologically or economically feasible in all instances to reduce
airborne concentrations to safe levels. In those workplaces,
respiratory protection is required to minimize workers' risks of acute
and chronic health effects. Although the incremental risk reduction
associated with this rulemaking cannot be quantified, it is evident
that increased filtering efficiency and enhanced filter reliability
must increase the margin of safety for respirator users.
As the last, and occasionally the only, defense against some acute
and chronic health hazards at work it is important that respirators be
reliable and that they perform in the manner and to the extent the user
and employer expect. If respirators fail to perform as expected, the
user will be at greatly increased risk of suffering serious, sometimes
fatal, [[Page 30352]] occupational disease or injury. In most
circumstances the respirator user has no way of knowing if respirator
performance is substandard. Except for the most acute res

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-13287. Public record. Not legal advice.