[Federal Register Volume 60, Number 110 (Thursday, June 8, 1995)]
[Rules and Regulations]
[Pages 30336-30398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13287]
[[Page 30335]]
_______________________________________________________________________
Part II
Department of Health and Human Services
Public Health Service
42 CFR Part 84
Department of Labor
Mine Safety and Health Administration
30 CFR Parts 11, 49, 56, 57, 58, 70, 72, and 75
Department of Labor
Mine Safety and Health Administration
Department of Health and Human Services
Centers for Disease Control and Prevention
_______________________________________________________________________
Respiratory Protective Devices; Final Rules and Notice
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules
and Regulations
[[Page 30336]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 84
RIN 0905-AB58
Respiratory Protective Devices
AGENCY: National Institute for Occupational Safety and Health (NIOSH),
Centers for Disease Control and Prevention, Public Health Service, HHS.
ACTION: Final rule.
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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:
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Annual
Section number of Annual Average burden per Annual burden
respondents frequency response hours
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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.
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Total................................... ........... ........... .................... 130,805 hr.
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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 responses to
substandard respirator performance, it is not possible to attribute
health effects to a failure of respiratory protection. Most of the
serious occupational diseases have long latency periods, so respirator
users typically would not know if they used an inferior device. Even
the relationship to workplace exposures can be obscured because of the
presumption that respirators provide effective protection.
Respriator purchasers and users expect and deserve to be able to
select respirators with complete confidence that they will perform with
a specific efficiency for a specific purpose. They rely on the NIOSH,
formerly MSHA/NIOSH, performance standards and certification program to
assure them that they can have that confidence.
These new particulate filter efficiency tests are needed to reduce
potential health risks that may result from leakage of small
particulates through some filters certified under the current
regulations (30 CFR part 11). For over a decade the filter penetration
tests contained in 30 CFR part 11 have been known to be deficient.
Leakage of small aerosols has been recognized as a problem that could
be corrected only by revising that regulation.
The magnitude of the filter leakage problem came into sharper focus
in the early 1990's when NIOSH and other researchers used modern
methods not available under the provisions of part 11 to measure
performance over a range of particle sizes. For certain models,
leakages higher than 50% were found. Not all respirator models exhibit
this high level of leakage, but 30 CFR part 11 testing does not
distinguish adequate from inadequate filters.
The respirator community acknowledges filter leakage to be a
problem. The American National Standards Institute (ANSI) Z88.2-1992
national standard, for example, states that 2 of the 3 types of
particulate respirators certified under 30 CFR part 11 should be used
only when the workplace particulate contaminant is know to have a mass
median aerodynamic diameter (MMAD) greater that 2 micrometer.
Compliance with aerosol size limitations such as those of the ANSI
Z88.2 would represent a major technologic and economic burden for
respirator users. Those burdens are great even for the largest
employers and exceed the capacity of smaller employers. Adequate worker
protection with DM and DFM respirators certified under 30 CFR part 11
can be assured only if employers conduct sophisticated and expensive
measurements of the size distribution of the aerosol in each workplace.
This is simply too expensive for the great majority of respirator
users, who may elect to use DM or DFM respirators without evaluating
aerosols in their workplaces, thereby placing their workers at
increased risk of occupational disease or disability. The only
alternative at present is for those employers to provide costly high
efficiency (HEPA) filters. The difficult and costly aerosol size
measurements are not needed when HEPA filters are used because they are
tested with the most penetrating size of aerosol. HEPA filters are
therefore known to be effective against any aerosol regardless of size.
The new 42 CFR part 84 filter efficiency tests use only the most
penetrating aerosol size, so all filters certified under these new
procedures will be effective against any size aerosol. This new rule
thereby corrects an acknowledged deficiency in existing filter
efficiency tests, removes from the workplace respirators that fail to
deliver the expected degree of worker protection, relieves employers of
the need to perform costly and difficult measurements of aerosol size
distribution, and provides alternatives to the expensive HEPA filters
in workplaces where the aerosol size is either unknown or is known to
be small.
This new rule continues to limit, as does the current 30 CFR part
11, the breathing resistance (inhalation and exhalation resistance) of
the respirator. Breathing resistance is significant to respirator
wearers in three ways. First, higher breathing resistance increases
leakage at the face seal of the respirator. Face seal leakage is
directly proportional to breathing resistance, other factors being
equal. Second, respirators with lower breathing resistance are more
comfortable and more acceptable to wearers. If a respirator is
uncomfortable to wear, workers are less inclined to use their
respirator as often as they should. Third, high breathing resistance
can be an unacceptable physiological burden on some workers. For a
worker with impaired pulmonary or cardiovascular function, high
breathing resistance may make respirator use impossible. In this rule,
NIOSH has increased the allowable inhalation and exhalation resistance
in consideration of minimizing economic impact, but NIOSH has
maintained the breathing resistance at a level that still will minimize
adverse impacts on the respirator user.
E.O. 12866 further requires the agency to determine whether the
proposed rule is ``economically significant'' (e.g., it does not have
an annual effect on the economy of $100 million). NIOSH generally
prepares a regulatory flexibility analysis, in accordance with the Act,
if the rule is expected to have a significant impact on a substantial
number of small entities. NIOSH does not believe that this final rule
will have an annual impact on the economy of $100 million, nor does
NIOSH believe that the rule will have a significant impact on a
substantial number of small firms.
This regulatory change affects only particulate respirators. A
total of 56 manufacturers hold respirator approvals, and 33 of these
hold approvals for particulate respirators. Based on inquiries
received, NIOSH believes that several additional manufacturers are
planning to submit applications for particulate filter products under
this new regulation.
Data are not available to define company size, market share, or
diversity of products for the current approval-holders. Projections of
impact are based on an understanding of manufacturers dependence on
existing approved particulate respirators. Of the 33 manufacturers that
have particulate filer approvals, 24 hold additional approvals for
devices other than particulate respirators, and nine have only
particulate filter approvals. One of these manufacturer holds approvals
for DM, DFM and HEPA respirators, while the remaining eight each hold
only a single particulate filter approval. Because all existing HEPA
filters are expected to pass the new certification tests, it appears
that only eight of 56 respirator manufacturers might be dependent upon
particulate filter respirators possibly at risk of not passing the new
certification tests without redesign. At least one of these eight
manufacturers commented favorably on this proposed rule, indicating
readiness to meet these new criteria.
Any manufacturer that cannot meet the new criteria immediately will
have three years in which to develop new products or face removal from
the approved respirator market. However, loss of approved respirator
status does not prohibit sales of the devices as non-approved units.
The non-approved respirator market appears to be very lucrative, with
several of the larger manufacturers participating. Non-approved
respirators are sold in many retail outlets including hardware, auto
supply, and department stores. Consumers purchase these devices for use
against nuisance dusts while [[Page 30353]] performing various home and
hobby-related activities.
While some current respirator manufacturers may experience negative
impacts, other manufacturers that are not now approval holders have
indicated an intention to enter this market. The new rule thus will
stimulate competition as new technologies are introduced and new
markets are developed. Furthermore, this rule enhances the ability of
domestic manufacturers to compete globally, especially in the European
Community. NIOSH expects to see more new approval holders develop as a
result of the new rule.
A high percentage of the respirator manufacturers are large
corporations or subsidiaries and are international in nature, although
several employ 100 or fewer persons. NIOSH does not have an estimate of
the total number employed by the 33 manufacturers of particulate
respirators. Neither does NIOSH have any indication of how many
employees are engaged solely in the manufacture of particulate
respirators. However, the respirator manufacturing industry in general
is mature and stable. A 1982 survey of the industry performed for NIOSH
covered 29 firms that were active at that time, the majority of which
continue to manufacture respirators in 1995. Of these, 12 were
subsidiaries of larger firms. Median total employment was 375. A large
portion of these workers were believed to be engaged in activities
unrelated to particulate respirator manufacturing. Sales figures
indicated respirator sales ranged from less than 1% to 10-15% of total
corporate sales.
NIOSH believes the industry profile remains basically the same it
was in 1982. That is, respirators do not represent the primary source
of sales income for any of the manufacturers that will be affected.
Because respirators represent a low percentage of overall sales, the
percentage of total employees involved in the manufacture of
respirators is believed also to be low. Therefore, few employees are
likely to be severely impacted by the new rule. Indeed, the increased
competition and opening of markets expected to result from the rule may
well enhance aggregate employment for both current and new approval
holders.
Most employers rely on government standards to determine acceptable
levels of respirator performance. It would be inefficient and
unreasonably costly for each of millions of occasional purchasers of
these inexpensive devices to independently attempt to determine which
devices operate effectively to filter out submicron toxic particles.
This rule removes a regulatory impediment to the improved design of
respirators by substituting a performance standard for an obsolete
specifications standard. The practical effect of this will be to enable
firms to substitute a more effective and efficient filter material in
lower-cost respirators. Respirators already using high efficiency
filters meeting 30 CFR part 11 requirements will not be affected by
this proposal. These respirators will not require modification to be
certified under this final rule, although the certification may not be
at the new P100 efficiency level. Although the category of performance
may be reduced from the previous HEPA rating, no design or development
costs are associated with the certification of these products.
NIOSH received limited responses to its request for comments and
data for projected estimates of cost for materials and labor for these
improved respirators. Several respirator manufacturers referred to a
survey conducted by their trade association as suggesting that costs of
this module would exceed $100 million, but specific cost estimates for
this module were not provided. The trade association reported that
their estimate was based largely on the surveyed manufacturers'
projections of procuring new equipment, procuring new materials, plant
retooling, and the like. The largest manufacturer of respirators did
not project the same cost impact on its products, even though that
manufacturer recommended changing the proposed rule to eliminate the
least costly class of proposed respirators and to increase the severity
of two testing parameters. Another manufacturer stated that the
``projected increased user cost for disposables of 42 CFR part 84 would
be between $440 and $990 million,'' based solely on impacts to that
manufacturer's products. This manufacturer forecast that prices to end
users would rise by 1.7- to 2.9-fold or 9- to 16-fold depending on
filter type.
Very limited data were submitted in support of any of these
estimates, but it appears that the large discrepancy between NIOSH and
industry cost estimates are attributable to 3 principal factors:
(1) Cost estimates by industry included many capital investmet
costs rather than recurring annual costs, inclusion of which improperly
inflated the annual cost projections.
(2) An erroneous assumption made by the manufacturer projecting the
greatest cost impact. That manufacturer assumed that the proposed fit
test would require all disposable respirators to have an elastomeric
flange. Additional costs attributed to consumer reaction to this
assumption were:
(a) expensive reusable elastomeric cartridge respirators replacing
inexpensive disposable models, and
(b) costly respirator maintenance and training programs associated
with reusable respirators.
Neither NIOSH nor other manufacturers projected either of these as
a consequence of the fit testing. In any event, the requirement for fit
testing was eliminated from the final rule. That represents a cost
saving in itself but this change also renders moot the question of
elastomeric flanges for disposable respirators.
(3) Two additional elements of the proposed rule were identified as
having significant cost impact: statistical evaluation of certification
test results and limitations on inhalation/exhalation resistance. These
were changed in the final rule to eliminate the statistical criterion
and to adopt the inhalation/ exhalation resistance levels requested by
the manufacturers. As a result and as discussed below under specific
topics, NIOSH does not believe that this rule will approach the $100
million threshold. In fact, NIOSH believes that over time
manufacturers' costs and prices to users will fall.
Commenters stated that the statistical treatment of test data as
included in the proposal would ``add greatly to the cost of filters and
respirators.'' One commenter estimated that the added manufacturing and
waste costs attributable to this provision would be 25-30% of the costs
attributable to the proposal. According to the commenters, the
replacement of the proposed statistical treatment of test data with the
less stringent statistical treatment proposed by NIOSH in 1987 or a
pass/fail criterion would remove the added cost implications of the
proposed rule.
As discussed previously, NIOSH has replaced the proposed
requirement for the statistical treatment of test data with the
recommended pass-fail criterion. Twenty filters are to be tested,
reduced from 30 to be required under the proposal. This change in the
final rule, based on technical concerns discussed previously, will
significantly reduce the cost implications of the final rule from the
estimated costs of the proposal.
The fit test requirements proposed under Secs. 84.181 and 84.182
were identified as another source of a significant portion of the costs
attributed to the proposed rule. The increased costs resulted from the
interpretation that the isoamyl acetate testing would necessitate
elastomeric inner flanges to be added to all certified disposable
respirators in all categories. [[Page 30354]] This interpretation led
to two conclusions that increased the cost estimates. The first
conclusion was that all disposable filter respirators would need to be
redesigned to include a costly elastomeric facepiece. The estimated
increased costs of disposable respirators led to the second conclusion
that the currently inexpensive and widely used disposable particulate
respirators would be replaced by costly reusable elastomeric cartridge
masks. This increased use of reusable masks was estimated to increase
users' costs of respirator maintenance and training programs not
associated with disposable respirators. The costs associated with the
use of an isoamyl acetate represented a substantial portion of the
projected cost impact of the proposed rule.
As discussed earlier, NIOSH has reconsidered the proposed
requirement for isoamyl acetate fit-testing of these respirators. Based
on technical considerations, the isoamyl acetate tests have not been
included in the final rule. NIOSH anticipates that currently accepted,
fit-testing procedures will continue to be used to assure a proper
respirator-to-face seal for each respirator user. Based on prior
experience with currently certified disposable respirators using these
procedures, no redesign of the facepiece seal of disposable respirators
will be required as a result of this final rule. Therefore, the cost
implications attributed to the isoamyl acetate fit tests are not
applicable to this final rule.
It is our understanding that substituting better filter material
will have negligible effects on the costs of filters, over the long
run. The material costs may be slightly increased, but are relatively
small compared to those estimates for statistical evaluation and fit
testing. The costs associated with these latter two have been greatly
reduced by the requirements in the final rule.
The demonstrated level of performance for filters will be
substantially more effective. Instead of an efficiency rate of 95
percent for removing particles sized at 1 to 2 micrometers in diameter,
they will demonstrate the ability to remove particles of less than 1
micrometer in diameter at a typical efficiency rate of 95 to 99.97
percent. The importance of this change will vary considerably from
workplace setting to setting. However, in at least some settings the
benefits will be considerable.
For example, the classes of particulate filter respirators
certified under this rule will meet or exceed the recommendations for
respiratory protective devices used for M. tuberculosis. Of the
currently NIOSH-certified respirators, only high-efficiency particulate
air (HEPA) filters meet or exceed these recommendations. The
certification to an enhanced performance level will create options for
the choice of respirators that adhere to the recommendations at reduced
expense. A disposable (one-time use) HEPA filter respirator generally
sells for around $7 to $10 and replaceable respirators equipped with
HEPA filters can cost $20 or more, with replacement filters costing
about $5 each. Replacement non-HEPA filters cost about $1 to $2 each.
Disposable non-HEPA filters cost about $1 to $8 each when purchased in
bulk. Costs for a N95 filter are expected to be less than those of a
current HEPA filter. Applications of new filter technologies and market
competition is expected to generally have the impact of reducing the
cost of the new respirators. At least one commenter has already
indicated that the 95% efficiency level respirators will be priced not
exceeding the cost of 30 CFR part 11 disposable DFM respirators, $5 to
$8 each.
NIOSH would expect similar effects--both improved health and cost
avoidance--in many other settings. NIOSH estimates that as many as
seven million workers use respirators at some time each year. NIOSH
estimates that employers annually purchase over 110 million disposable
respirators.
There are approximately 35 manufacturers of these respiratory
devices. Most of these already possess or have access to test equipment
needed to perform the new filter tests. As is currently required under
30 CFR part 11, NIOSH will continue to require that applicants conduct
or have conducted examinations, inspections, and tests of respirator
performance at least equivalent to those set by the respirator
certification tests. This is to assure that all necessary research and
development is conducted by the applicant prior to submitting an
application to the Federal Government for testing of the respirator by
NIOSH. For those manufacturers that do not currently possess this
capability, NIOSH estimates that the purchase of this equipment
represents an investment of approximately $60,000. Amortized over time,
this would not represent a significant cost for most manufacturers.
Commenters indicated that the projected costs of new, updated test
instruments for the filter efficiency testing contributed significantly
to the costs reported to be attributable to the proposed rule. NIOSH
agrees that if manufacturers opt to purchase newly developed
instruments, this represents a significant investment. As discussed
previously, the filter efficiency tests of this final rule can be
conducted using the instrumentation previously specified for the
testing of high efficiency filters under 30 CFR part 11. Therefore, the
purchase of new test instruments is not required for most
manufacturers. Further, the purchase of test instruments represents a
capital investment amortized over time, not an annual recurring cost.
Filter materials are currently available that can be substituted
into present filter designs with minimal redesign (if any) to meet the
performance requirements of the new tests. Some currently NIOSH-
certified respirators have, when tested using the new standards,
demonstrated acceptable performance. Therefore, little or no cost will
be needed to develop suitable filtration materials or redesign existing
devices. However, NIOSH does realize that additional development and
redesign costs may be incurred to augment the presently available
products. NIOSH specifically requested relevant data and comments on
projected costs of redesign of respirators.
One commenter cited the cost of commercially available filter media
to meet the proposed standards as dramatically increased over the
present cost of the existing 30 CFR part 11 disposable dust/mist
requirements. The cost of present dust/mist media was stated as between
60 cents and one dollar per square yard, whereas the cost of
commercially available filter media to meet the proposed 42 CFR part 84
requirements is between 12 dollars and 17 dollars per square yard,
depending on the type (A, B, or C), and whether it is for the
``solids'' or ``liquid/solids'' category. Two other commenters
indicated the availability of prototype respirators and filters that
could be marketed for little or no cost increase from existing dust/
fume/mist respirators and filters.
Several comments were received stating that the combination of
proposed initial inhalation and exhalation resistance limits and
efficiency levels might require increasing the surface area of filters.
It was asserted that an increase in filter surface area to meet these
requirements would ``increase substantially the raw material and
manufacturing costs of respirator protection.'' For the technical
reasons discussed previously, the initial inhalation and exhalation
resistances have been increased in the final rule to the values
recommended by these commenters. Adoption of these values will allow
``latitude to develop filters at [[Page 30355]] a reasonable cost
without compromising safety or comfort to the user,'' according to the
comments.
In summary, NIOSH did not believe the proposed rule change was
``economically significant'' within the definition of E.O. 12866 based
on the cost projections attributable to the proposal that were provided
to NIOSH and those modifications incorporated into the final rule.
Notwithstanding these general conclusions, there may be some
manufacturers that will find it financially difficult, or a poor
investment, to meet the new standards. NIOSH expects such problems to
result from free market competition rather than the specific standards
of these final regulations. That is, most knowledgeable employers would
purchase more cost-effective respirators voluntarily and force major
changes in the market if the present regulatory barriers were removed.
List of Subjects in 42 CFR Part 84
Administrative practice and procedure, Incorporation by reference,
Labeling, Mine safety and health, Occupational safety and health,
Personal protective equipment, Reporting and recordkeeping
requirements, Respirators.
Dated: April 14, 1995.
Philip R. Lee,
Assistant Secretary for Health.
Dated: April 14, 1995.
Donna E. Shalala,
Secretary.
For the reasons set out in the preamble, 42 CFR part 84 is added to
read as follows:
PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Subpart A--General Provisions
Sec.
84.1 Purpose.
84.2 Definitions.
84.3 Respirators for mine rescue or other emergency use in mines.
Subpart B--Application for Approval
84.10 Application procedures.
84.11 Contents of application.
84.12 Delivery of respirators and components by applicant;
requirements.
Subpart C--Fees
84.20 Examination, inspection, and testing of complete respirator
assemblies; fees.
84.21 Examination, inspection, and testing of respirator components
or subassemblies; fees.
84.22 Unlisted fees; additional fees; payment by applicant prior to
approval.
Subpart D--Approval and Disapproval
84.30 Certificates of approval; scope of approval.
84.31 Certificates of approval; contents.
84.32 Notice of disapproval.
84.33 Approval labels and markings; approval of contents; use.
84.34 Revocation of certificates of approval.
84.35 Changes or modifications of approved respirators; issuance of
modification of certificate of approval.
84.36 Delivery of changed or modified approved respirator.
Subpart E--Quality Control
84.40 Quality control plans; filing requirements.
84.41 Quality control plans; contents.
84.42 Proposed quality control plans; approval by the Institute.
84.43 Quality control records; review by the Institute; revocation
of approval.
Subpart F--Classification of Approved Respirators; Scope of Approval;
Atmospheric Hazards; Service Time
84.50 Types of respirators to be approved; scope of approval.
84.51 Entry and escape, or escape only; classification.
84.52 Respiratory hazards; classification.
84.53 Service time; classification.
Subpart G--General Construction and Performance Requirements
84.60 Construction and performance requirements; general.
84.61 General construction requirements.
84.62 Component parts; minimum requirements.
84.63 Test requirements; general.
84.64 Pretesting by applicant; approval of test methods.
84.65 Conduct of examinations, inspections, and tests by the
Institute; assistance by applicant; observers; recorded data; public
demonstrations.
84.66 Withdrawal of applications; refund of fees.
Subpart H--Self-Contained Breathing Apparatus
84.70 Self-contained breathing apparatus; description.
84.71 Self-contained breathing apparatus; required components.
84.72 Breathing tubes; minimum requirements.
84.73 Harnesses; installation and construction; minimum
requirements.
84.74 Apparatus containers; minimum requirements.
84.75 Half-mask facepieces, full facepieces, mouthpieces; fit;
minimum requirements.
84.76 Facepieces; eyepieces; minimum requirements.
84.77 Inhalation and exhalation valves; minimum requirements.
84.78 Head harnesses; minimum requirements.
84.79 Breathing gas; minimum requirements.
84.80 Interchangeability of oxygen and air prohibited.
84.81 Compressed breathing gas and liquefied breathing gas
containers; minimum requirements.
84.82 Gas pressure gages; minimum requirements.
84.83 Timers; elapsed time indicators; remaining service life
indicators; minimum requirements.
84.84 Hand-operated valves; minimum requirements.
84.85 Breathing bags; minimum requirements.
84.86 Component parts exposed to oxygen pressures; minimum
requirements.
84.87 Compressed gas filters; minimum requirements.
84.88 Breathing-bag test.
84.89 Weight requirement.
84.90 Breathing resistance test; inhalation.
84.91 Breathing resistance test; exhalation.
84.92 Exhalation valve leakage test.
84.93 Gas flow test; open circuit apparatus.
84.94 Gas flow test; closed circuit apparatus.
84.95 Service-time test; open circuit apparatus.
84.96 Service-time test; closed circuit apparatus.
84.97 Test for carbon dioxide in inspired gas; open- and closed-
circuit apparatus; maximum allowable limits.
84.98 Tests during low temperature operation.
84.99 Man tests; testing conditions; general requirements.
84.100 Man tests 1, 2, 3, and 4; requirements.
84.101 Man test 5; requirements.
84.102 Man test 6; requirements.
84.103 Man tests; performance requirements.
84.104 Gas tightness test; minimum requirements.
Tables to Subpart H of Part 84
Subpart I--Gas Masks
84.110 Gas masks; description.
84.111 Gas masks; required components.
84.112 Canisters and cartridges in parallel; resistance
requirements.
84.113 Canisters and cartridges; color and markings; requirements.
84.114 Filters used with canisters and cartridges; location;
replacement.
84.115 Breathing tubes; minimum requirements.
84.116 Harnesses; installation and construction; minimum
requirements.
84.117 Gas mask containers; minimum requirements.
84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit;
minimum requirements.
84.119 Facepieces; eyepieces; minimum requirements.
84.120 Inhalation and exhalation valves; minimum requirements.
84.121 Head harnesses; minimum requirements.
84.122 Breathing resistance test; minimum requirements.
84.123 Exhalation valve leakage test.
84.124 Facepiece tests; minimum requirements. [[Page 30356]]
84.125 Particulate tests; canisters containing particulate filters;
minimum requirements.
84.126 Canister bench tests; minimum requirements.
Tables to Subpart I of Part 84
Subpart J--Supplied-Air Respirators
84.130 Supplied-air respirators; description.
84.131 Supplied-air respirators; required components.
84.132 Breathing tubes; minimum requirements.
84.133 Harnesses; installation and construction; minimum
requirements.
84.134 Respirator containers; minimum requirements.
84.135 Half-mask facepieces, full facepieces, hoods, and helmets;
fit; minimum requirements.
84.136 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
84.137 Inhalation and exhalation valves; check valves; minimum
requirements.
84.138 Head harnesses; minimum requirements.
84.139 Head and neck protection; supplied-air respirators; minimum
requirements.
84.140 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.141 Breathing gas; minimum requirements.
84.142 Air supply source; hand-operated or motor driven air
blowers; Type A supplied-air respirators; minimum requirements.
84.143 Terminal fittings or chambers; Type B supplied-air
respirators; minimum requirements.
84.144 Hand-operated blower test; minimum requirements.
84.145 Motor-operated blower test; minimum requirements.
84.146 Method of measuring the power and torque required to operate
blowers.
84.147 Type B supplied-air respirator; minimum requirements.
84.148 Type C supplied-air respirator, continuous-flow class;
minimum requirements.
84.149 Type C supplied-air respirator, demand and pressure demand
class; minimum requirements.
84.150 Air-supply line tests; minimum requirements.
84.151 Harness test; minimum requirements.
84.152 Breathing tube test; minimum requirements.
84.153 Airflow resistance test, Type A and Type AE supplied-air
respirators; minimum requirements.
84.154 Airflow resistance test; Type B and Type BE supplied-air
respirators; minimum requirements.
84.155 Airflow resistance test; Type C supplied-air respirator,
continuous flow class and Type CE supplied-air respirator; minimum
requirements.
84.156 Airflow resistance test; Type C supplied-air respirator,
demand class; minimum requirements.
84.157 Airflow resistance test; Type C supplied-air respirator,
pressure-demand class; minimum requirements.
84.158 Exhalation valve leakage test.
84.159 Man tests for gases and vapors; supplied-air respirators;
general performance requirements.
84.160 Man tests for gases and vapors; Type A and Type AE
respirators; test requirements.
84.161 Man tests for gases and vapors; Type B and Type BE
respirators; test requirements.
84.162 Man test for gases and vapors; Type C respirators,
continuous-flow class and Type CE supplied-air respirators; test
requirements.
84.163 Man test for gases and vapors; Type C supplied-air
respirators, demand and pressure-demand classes; test requirements.
Tables to Subpart J of Part 84
Subpart K--Non-Powered Air-Purifying Particulate Respirators
84.170 Non-powered air-purifying particulate respirators;
description.
84.171 Non-powered air-purifying particulate respirators; required
components.
84.172 Breathing tubes; minimum requirements.
84.173 Harnesses; installation and construction; minimum
requirements.
84.174 Respirator containers; minimum requirements.
84.175 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
84.176 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
84.177 Inhalation and exhalation valves; minimum requirements.
84.178 Head harnesses; minimum requirements.
84.179 Non-powered air-purifying particulate respirators; filter
identification.
84.180 Airflow resistance tests.
84.181 Non-powered air-purifying particulate filter efficiency
level determination.
84.182 Exhalation valve leakage test; minimum requirements.
Subpart L--Chemical Cartridge Respirators
84.190 Chemical cartridge respirators; description.
84.191 Chemical cartridge respirators; required components.
84.192 Cartridges in parallel; resistance requirements.
84.193 Cartridges; color and markings; requirements.
84.194 Filters used with chemical cartridges; location;
replacement.
84.195 Breathing tubes; minimum requirements.
84.196 Harnesses; installation and construction; minimum
requirements.
84.197 Respirator containers; minimum requirements.
84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods,
and helmets; fit; minimum requirements.
84.199 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
84.200 Inhalation and exhalation valves; minimum requirements.
84.201 Head harnesses; minimum requirements.
84.202 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.203 Breathing resistance test; minimum requirements.
84.204 Exhalation valve leakage test; minimum requirements.
84.205 Facepiece test; minimum requirements.
84.206 Particulate tests; respirators with filters; minimum
requirements; general.
84.207 Bench tests; gas and vapor tests; minimum requirements;
general.
Tables to Subpart L of Part 84
Subpart M--[Reserved]
Subpart N--Special Use Respirators
84.250 Vinyl chloride respirators; description.
84.251 Required components.
84.252 Gas masks; requirements and tests.
84.253 Chemical-cartridge respirators; requirements and tests.
84.254 Powered air-purifying respirators; requirements and tests.
84.255 Requirements for end-of-service-life indicator.
84.256 Quality control requirements.
84.257 Labeling requirements.
84.258 Fees.
Subparts O through JJ [Reserved]
Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray; Powered Air-
Purifying High Efficiency Respirators and Combination Gas Masks
84.1100 Scope and effective dates.
84.1101 Definitions.
84.1102 Examination, inspection and testing of complete respirator
assemblies; fees.
84.1103 Approval labels and markings; approval of contents; use.
84.1130 Respirators; description.
84.1131 Respirators; required components.
84.1132 Breathing tubes; minimum requirements.
84.1133 Harnesses; installation and construction; minimum
requirements.
84.1134 Respirator containers; minimum requirements.
84.1135 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
84.1136 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
84.1137 Inhalation and exhalation valves; minimum requirements.
84.1138 Head harnesses; minimum requirements.
84.1139 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.1140 Dust, fume, and mist respirators; performance requirements;
general.
84.1141 Isoamyl acetate tightness test; dust, fume, and mist
respirators designed for respiratory protection against fumes of
various metals having an air contamination level not less than 0.05
milligram per cubic meter; minimum requirements. [[Page 30357]]
84.1142 Isoamyl acetate tightness test; respirators designed for
respiratory protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter, or
against radionuclides; minimum requirements.
84.1143 Dust, fume, and mist air-purifying filter tests;
performance requirements; general.
84.1144 Silica dust test for dust, fume, and mist respirators;
single-use or reusable filters; minimum requirements.
84.1145 Silica dust test; non-powered single-use dust respirators;
minimum requirements.
84.1146 Lead fume test for dust, fume, and mist respirators;
minimum requirements.
84.1147 Silica mist test for dust, fume, and mist respirators;
minimum requirements.
84.1148 Tests for respirators designed for respiratory protection
against more than one type of dispersoid; minimum requirements.
84.1149 Airflow resistance tests; all dust, fume, and mist
respirators; minimum requirements.
84.1150 Exhalation valve leakage test; minimum requirements.
84.1151 DOP filter test; respirators designed as respiratory
protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter and
against radionuclides; minimum requirements.
84.1152 Silica dust loading test; respirators designed as
protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter and
against radionuclides; minimum requirements.
84.1153 Dust, fume, mist, and smoke tests; canister bench tests;
gas mask canisters containing filters; minimum requirements.
84.1154 Canister and cartridge requirements.
84.1155 Filters used with canisters and cartridges; location;
replacement.
84.1156 Pesticide respirators; performance requirements; general.
84.1157 Chemical cartridge respirators with particulate filters;
performance requirements; general.
84.1158 Dust, fume, and mist tests; respirators with filters;
minimum requirements; general.
Tables to Subpart KK of Part 84
Authority: 29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C. 3,
5, 7, 811, 842(h), 844.
Subpart A--General Provisions
Sec. 84.1 Purpose.
The purpose of the regulations contained in this part 84 is:
(a) To establish procedures and prescribe requirements which must
be met in filing applications for approval by the National Institute
for Occupational Safety and Health of respirators or changes or
modifications of approved respirators;
(b) To establish a schedule of fees to be charged each applicant
for the inspections, examinations, and testing conducted by the
Institute under the provisions of this part;
(c) To provide for the issuance of certificates of approval or
modifications of certificates of approval for respirators which have
met the applicable construction, performance, and respiratory
protection requirements set forth in this part; and
(d) To specify minimum requirements and to prescribe methods to be
employed by the Institute and by the applicant in conducting
inspections, examinations, and tests to determine the effectiveness of
respirators used during entry into or escape from hazardous
atmospheres.
Sec. 84.2 Definitions.
As used in this part--
(a) Applicant means an individual, partnership, company,
corporation, association, or other organization that designs,
manufactures, assembles, or controls the assembly of a respirator and
who seeks to obtain a certificate of approval for such respirator.
(b) Approval means a certificate or formal document issued by the
Institute stating that an individual respirator or combination of
respirators has met the minimum requirements of this part, and that the
applicant is authorized to use and attach an approval label to any
respirator, respirator container, or instruction card for any
respirator manufactured or assembled in conformance with the plans and
specifications upon which the approval was based, as evidence of such
approval.
(c) Approved means conforming to the minimum requirements of this
part.
(d) Auxiliary equipment means a self-contained breathing apparatus,
the use of which is limited in underground mine rescue and recovery
operations to situations where the wearer has ready access to fresh air
and at least one crew equipped with approved self-contained breathing
apparatus of 2 hours or longer rating, is in reserve at a fresh-air
base.
(e) Certification and Quality Assurance Branch means the
Certification and Quality Assurance Branch, Division of Safety
Research, Appalachian Laboratory for Occupational Safety and Health,
National Institute for Occupational Safety and Health, 1095 Willowdale
Road, Morgantown, West Virginia 26505-2888.
(f) Compressed-breathing gas means oxygen or air stored in a
compressed state and supplied to the wearer in gaseous form.
(g) dBA means sound pressure levels in decibels, as measured with
the A-weighted network of a standard sound level meter using slow
response.
(h) Dust means a solid mechanically produced particle with a size
ranging from submicroscopic to macroscopic.
(i) Respirators for entry into and escape from means respiratory
devices providing protection during entry into and escape from
hazardous atmospheres.
(j) Respirators for escape only means respiratory devices providing
protection only during escape from hazardous atmospheres.
(k) A facepiece or mouthpiece is a respirator component designed to
provide a gas-tight or dust-tight fit with the face and may include
headbands, valves, and connections for canisters, cartridges, filters,
or respirable gas source.
(l) Final inspection means that activity carried out on a product
after all manufacturing and assembly operations are completed to insure
completeness and adherence to performance or other specifications,
including satisfactory appearance.
(m) Fume means a solid condensation particle, generally less than 1
micrometer in diameter.
(n) Gas means an aeriform fluid which is in a gaseous state at
ordinary temperature and pressure.
(o) Hazardous atmosphere means:
(1) Any atmosphere containing a toxic or disease producing gas,
vapor, dust, fume, mist, or pesticide, either immediately or not
immediately dangerous to life or health; or
(2) Any oxygen-deficient atmosphere.
(p) A hood or helmet is a respirator component which covers the
wearer's head and neck, or head, neck, and shoulders, and is supplied
with incoming respirable air for the wearer to breathe. It may include
a headharness and connection for a breathing tube.
(q) Immediately dangerous to life or health means conditions that
pose an immediate threat to life or health or conditions that pose an
immediate threat of severe exposure to contaminants, such as
radioactive materials, which are likely to have adverse cumulative or
delayed effects on health.
(r) Incoming inspection means the activity of receiving, examining,
and accepting only those materials and parts whose quality conforms to
specification requirements.
(s) In-process inspection means the control of products at the
source of production and at each step of the manufacturing process, so
that departures from specifications can be [[Page 30358]] corrected
before defective components or materials are assembled into the
finished product.
(t) Institute means the National Institute for Occupational Safety
and Health, Department of Health and Human Services.
(u) Liquefied-breathing gas means oxygen or air stored in liquid
form and supplied to the wearer in a gaseous form.
(v) Mist means a liquid condensation particle with a size ranging
from submicroscopic to macroscopic.
(w) MSHA means the Mine Safety and Health Administration, U.S.
Department of Labor.
(x) Not immediately dangerous to life or health means any hazardous
atmosphere which may produce physical discomfort immediately, chronic
poisoning after repeated exposure, or acute adverse physiological
symptoms after prolonged exposure.
(y) Oxygen-deficient atmosphere means an atmosphere which contains
an oxygen partial pressure of less than 148 millimeters of mercury
(19.5 percent by volume at sea level).
(z) Powered air-purifying respirator means a device equipped with a
facepiece, hood, or helmet, breathing tube, canister, cartridge,
filter, canister with filter, or cartridge with filter, and a blower.
(aa) Respirator means any device designed to provide the wearer
with respiratory protection against inhalation of a hazardous
atmosphere.
(bb) Single-use respirator means a respirator that is entirely
discarded after excessive resistance, sorbent exhaustion, or physical
damage renders it unsuitable for further use.
(cc) Vapor means the gaseous state of a substance that is solid or
liquid at ordinary temperature and pressure.
Sec. 84.3 Respirators for mine rescue or other emergency use in mines.
(a)(1) NIOSH and the Mine Safety and Health Administration (MSHA),
U.S. Department of Labor, shall jointly review and issue certifications
for respirators used for mine emergencies and mine rescue, including
any associated service-life plans, users' manuals and other supporting
documentation.
(2) Each certification for a respirator designed for mine rescue or
other emergency use in mines shall include, as a condition of approval,
any use limitations related to mine safety and health.
(b) NIOSH and MSHA shall jointly determine appropriate recall and
retrofit remedies for field complaints or identified deficiencies
involving any respirators used in the mining environment.
Subpart B--Application for Approval
Sec. 84.10 Application procedures.
(a) Inspection, examination, and testing leading to the approval of
the types of respirators classified in subpart F of this part shall be
undertaken by the Institute only pursuant to written applications which
meet the minimum requirements set forth in this subpart B.
(b) Applications shall be submitted to the Certification and
Quality Assurance Branch, and shall be accompanied by a check, bank
draft, or money order in the amount specified in subpart C of this
part, payable to the order of the National Institute for Occupational
Safety and Health.
(c) Except as provided in Sec. 84.64, the examination, inspection,
and testing of all respirators shall be conducted by the Certification
and Quality Assurance Branch.
(d) Applicants, manufacturers, or their representatives may visit
or communicate with the Certification and Quality Assurance Branch in
order to discuss the requirements for approval of any respirator or the
proposed designs thereof. No charge shall be made for such consultation
and no written report shall be issued to applicants, manufacturers, or
their representatives by the Institute as a result of such
consultation.
(e) Respirators having electrical or electronic components that are
required to be permissible under chapter I of title 30 shall be tested
in accordance with 30 CFR part 18. Applications for approval of such
respirators by MSHA shall be submitted in writing to: MSHA, Approval
and Certification Center, Box 251, Industrial Park Road, Triadelphia,
West Virginia 26059.
Sec. 84.11 Contents of application.
(a) Each application for approval shall contain a complete written
description of the respirator for which approval is requested together
with drawings and specifications (and lists thereof) showing full
details of construction of the respirator and of the materials used.
(b) Drawings shall be titled, numbered, and dated; any revision
dates shall be shown on the drawings, and the purpose of each revision
being sought shall be shown on the drawing or described on an
attachment to the drawing to which it applies.
(c) Each application for approval shall contain a proposed plan for
quality control which meets the minimum requirements set forth in
subpart E of this part.
(d) Each application shall contain a statement that the respirator
has been pretested by the applicant as prescribed in Sec. 84.64, and
shall include the results of such tests.
(e) Each application for approval shall contain a statement that
the respirator and component parts submitted for approval are either
prototypes, or made on regular production tooling, with no operation
included which will not be incorporated in regular production
processing.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Sec. 84.12 Delivery of respirators and components by applicant;
requirements.
(a) Each applicant shall, when an application is filed pursuant to
Sec. 84.10, be advised by the Institute of the total number of
respirators and component parts required for testing.
(b) The applicant shall deliver, at his own expense, the number of
completely assembled respirators and component parts required for
testing, to the Certification and Quality Assurance Branch.
(c) Respirators and component parts submitted for approval must be
made from materials specified in the application.
(d) One completely assembled respirator approved under the
provisions of this part may be retained by the Institute as a
laboratory exhibit, the remaining respirators may be returned to the
applicant at his own expense, upon written request within 30 days after
notice of approval. If no such request is made, the respirators will be
disposed of by the Institute in such manner as it deems appropriate.
(e) Where a respirator fails to meet the requirements for approval
set forth in this part, all respirators and components delivered in
accordance with this section may be returned to the applicant at his
own expense, upon written request within 30 days after notice of
disapproval. If no such request is made, the respirators will be
disposed of by the Institute in such manner as it deems appropriate.
Subpart C--Fees
Sec. 84.20 Examination, inspection, and testing of complete respirator
assemblies; fees.
Except as provided in Sec. 84.22, the following fees shall be
charged by the Institute for the examination, inspection and testing of
complete respirator assemblies:
Self-contained breathing apparatus:
Entry and escape, 1 hour or more............................. $3,500
[[Page 30359]]
Entry and escape, less than 1 hour........................... 2,750
Escape only.................................................. 2,000
Gas masks:
Single hazard................................................ 1,100
Type N....................................................... 4,100
Supplied-air respirators....................................... 750
Particulate respirators........................................ 1,250
Chemical cartridge respirators................................. 1,150
Sec. 84.21 Examination, inspection, and testing of respirator
components or subassemblies; fees.
Except as provided in Sec. 84.22, the following fees shall be
charged by the Institute for the examination, inspection and testing of
the individual respirator components or subassemblies:
Facepieces....................................................... $450
Canisters........................................................ 900
Cartridges....................................................... 600
Filters.......................................................... 650
Hoses............................................................ 250
Blowers.......................................................... 250
Harnesses........................................................ 100
Sec. 84.22 Unlisted fees; additional fees; payment by applicant prior
to approval.
(a) Applications for the examination, inspection and testing of
complete respirator assemblies which are not listed in Sec. 84.20, or
for the examination, inspection, and testing of respirator components
or subassemblies which are not listed in Sec. 84.21, shall be
accompanied by the following deposits:
Complete respirator assembly................................... $1,500
Each individual component or subassembly....................... 500
(b) The Institute reserves the right to conduct any examination,
inspection, or test it deems necessary to determine the quality and
effectiveness of any listed or unlisted respirator assembly or
respirator component or subassembly, and to assess the cost of such
examinations, inspections, or tests against the applicant prior to the
issuance of any approval for such assembly, component, or subassembly.
(c) The fees charged for the examination, inspection, and testing
of unlisted respirator assemblies, unlisted individual respirator
components or subassemblies, and for the additional examination,
inspection, and testing of listed respirator assemblies and components
or subassemblies shall be at the rate of $100 per day for each man-day
required to be expended by the Institute.
(d) Upon completion of all examinations, inspections, and tests of
unlisted respirator assemblies or components, or following the
completion of any additional examination, inspections, or tests of
listed assemblies, or components or subassemblies, including retesting
subsequent to disapproval, the Institute shall advise the applicant in
writing of the total cost assessed and the additional amount, if any,
which must be paid to the Institute as a condition of approval.
(e) In the event the amount assessed by the Institute for unlisted
assemblies, or components or subassemblies is less than the amount of
the deposit submitted in accordance with paragraph (a) of this section,
the Institute shall refund the overpayment upon the issuance of any
approval or notice of disapproval.
Subpart D--Approval and Disapproval
Sec. 84.30 Certificates of approval; scope of approval.
(a) The Institute shall issue certificates of approval pursuant to
the provisions of this subpart only for individual, completely
assembled respirators which have been examined, inspected, and tested,
and which meet the minimum requirements set forth in subparts H through
L of this part, as applicable.
(b) The Institute will not issue certificates of approval for any
respirator component or for any respirator subassembly.
(c) The Institute shall not issue an informal notification of
approval. However, if the application for approval, submitted in
accordance with Sec. 84.11, states that the submitted respirator and
component parts are only prototypes, the Institute will examine,
inspect, and test such respirator and component parts in accordance
with the provisions of this part. If, upon completion of such
examinations, inspections and tests, it is found that the prototype
meets the minimum requirements set forth in this part, the Institute
may inform the applicant, in writing, of the results of the
examinations, inspections, and tests, and may require him to resubmit
respirators and component parts made on regular production tooling,
with no operations included which will not be incorporated in regular
production processing, for further examination, inspection, and
testing, prior to issuance of the certificate of approval.
(d) Applicants required to resubmit respirators and component parts
made on regular production tooling, with no operation included which
will not be incorporated in regular production processing, shall be
charged fees in accordance with subpart C of this part.
Sec. 84.31 Certificates of approval; contents.
(a) The certificate of approval shall contain a classification and
a description of the respirator or combination of respirators for which
it is issued, as provided in this part.
(b) The certificate of approval shall specifically set forth any
restrictions or limitations on the respirator's use in hazardous
atmospheres.
(c) Each certificate of approval shall be accompanied by the
drawings and specifications (and lists thereof) submitted by the
applicant in accordance with Sec. 84.11. These drawings and
specifications shall be referenced in the certificate of approval, and
shall be maintained by the applicant. The drawings and specifications
listed in each certificate of approval shall set forth in detail the
design and construction requirements which shall be met by the
applicant during commercial production of the respirator.
(d) Each certificate of approval shall be accompanied by a
reproduction of the approval label design to be employed by the
applicant with each approved respirator, as provided in Sec. 84.33.
(e) No test data or specific laboratory findings will accompany any
certificate of approval, however, the Institute will release pertinent
test data and specific findings upon written request by the applicant,
or as required by statute or regulation.
(f) Each certificate of approval shall also contain the approved
quality control plan as specified in Sec. 84.42.
Sec. 84.32 Notice of disapproval.
(a) If, upon the completion of the examinations, inspections, and
tests required to be conducted in accordance with the provisions of
this part, it is found that the respirator does not meet the minimum
requirements set forth in this part, the Institute shall issue a
written notice of disapproval to the applicant.
(b) Each notice of disapproval shall be accompanied by all
pertinent data or findings with respect to the defects of the
respirator for which approval was sought with a view to the possible
correction of any such defects.
(c) The Institute shall not disclose, except to the applicant or as
required by statute or regulation, any data, findings, or other
information with respect to any respirator for which a notice of
disapproval is issued.
Sec. 84.33 Approval labels and markings; approval of contents; use.
(a) Full-scale reproductions of approval labels and markings, and a
sketch or description of the method of application and position on the
harness, container, canister, cartridge, filter, or
[[Page 30360]] other component, together with instructions for the use
and maintenance of the respirator shall be submitted to the Institute
for approval.
(b) Approval labels shall bear the emblem of the National Institute
for Occupational Safety and Health and the seal of the Department of
Health and Human Services, the applicant's name and address, an
approval number assigned by the Institute and, where appropriate,
restrictions or limitations placed upon the use of the respirator by
the Institute. The approval number assigned by the Institute shall be
designated by the prefix TC and a serial number.
(c) The Institute shall, where necessary, notify the applicant when
additional labels, markings, or instructions will be required.
(d) Approval labels and markings shall only be used by the
applicant to whom they were issued.
(e) Legible reproductions or abbreviated forms of the label
approved by the Institute for use on each respirator shall be attached
to or printed at the following locations:
------------------------------------------------------------------------
Respirator type Label type Location
------------------------------------------------------------------------
Self-contained Entire............... Harness assembly and
breathing apparatus. canister (where
applicable).
Gas mask............. Entire............... Mask container and
canister.
Supplied air ......do............. Respirator container or
respirator. instruction card.
Particulate ......do............. Respirator container and
respirator. filter container.
Abbreviated.......... Filters.
Chemical-cartridge Entire............... Respirator container,
respirator. cartridge container, and
filter containers (where
applicable).
Abbreviated.......... Cartridges and filters and
filter containers.
------------------------------------------------------------------------
(f) The use of any Institute approval label obligates the applicant
to whom it is issued to maintain or cause to be maintained the approved
quality control sampling schedule and the acceptable quality level for
each characteristic tested, and to assure that it is manufactured
according to the drawings and specifications upon which the certificate
of approval is based.
(g) Each respirator, respirator component, and respirator container
shall, as required by the Institute to assure quality control and
proper use of the respirator, be labeled distinctly to show the name of
the applicant, and the name and letters or numbers by which the
respirator or respirator component is designated for trade purposes,
and the lot number, serial number, or approximate date of manufacture.
Sec. 84.34 Revocation of certificates of approval.
The Institute reserves the right to revoke, for cause, any
certificate of approval issued pursuant to the provisions of this part.
Such causes include, but are not limited to, misuse of approval labels
and markings, misleading advertising, and failure to maintain or cause
to be maintained the quality control requirements of the certificate of
approval.
Sec. 84.35 Changes or modifications of approved respirators; issuance
of modification of certificate of approval.
(a) Each applicant may, if he desires to change any feature of an
approved respirator, request a modification of the original certificate
of approval issued by the Institute for such respirator by filing an
application for such modification in accordance with the provisions of
this section.
(b) Applications shall be submitted as for an original certificate
of approval, with a request for a modification of the existing
certificate to cover any proposed change.
(c) The application shall be accompanied by appropriate drawings
and specifications, and by a proposed quality control plan which meets
the requirements of subpart E of this part.
(d) The application for modification, together with the
accompanying material, shall be examined by the Institute to determine
whether testing will be required.
(e) The Institute shall inform the applicant of the fee required
for any additional testing and the applicant will be charged for the
actual cost of any examination, inspection, or test required, and such
fees shall be submitted in accordance with the provisions of subpart C
of this part.
(f) If the proposed change or modification meets the requirements
of this part, a formal certificate of modification will be issued,
accompanied, where necessary, by a list of new and revised drawings and
specifications covering the change(s) and reproductions of revised
approval labels.
(The information collections contained in this section are approved
under OMB control number 0920-0109.)
Sec. 84.36 Delivery of changed or modified approved respirator.
An approved respirator for which a formal certificate of
modification has been issued shall be delivered, with proper markings
and containers, by the applicant to the Certification and Quality
Assurance Branch, as soon as it is commercially produced.
Subpart E--Quality Control
Sec. 84.40 Quality control plans; filing requirements.
As a part of each application for approval or modification of
approval submitted pursuant to this part, each applicant shall file
with the Institute a proposed quality control plan which shall be
designed to assure the quality of respiratory protection provided by
the respirator for which approval is sought.
Sec. 84.41 Quality control plans; contents.
(a) Each quality control plan shall contain provisions for the
management of quality, including:
(1) Requirements for the production of quality data and the use of
quality control records;
(2) Control of engineering drawings, documentations, and changes;
(3) Control and calibration of measuring and test equipment;
(4) Control of purchased material to include incoming inspection;
(5) Lot identification, control of processes, manufacturing,
fabrication, and assembly work conducted in the applicant's plant;
(6) Audit of final inspection of the completed product; and
(7) The organizational structure necessary to carry out these
provisions.
(b) Each provision for incoming and final inspection in the quality
control plan shall include a procedure for the selection of a sample of
respirators and the components thereof for testing, in accordance with
procedures set forth in Military Standard MIL-STD-414, 11 June 1957,
including Change Notice No. 1, ``Sampling Procedures and Tables for
Inspection by Variables for Percent Defective,'' or an approved
equivalent sampling procedure, or an approved
[[Page 30361]] combination of sampling procedures. The procedure of
Military Standard MIL-STD-105D, 29 April 1963, ``Sampling Procedures
and Tables for Inspection by Attributes,'' is an example of an
equivalent sampling procedure. MIL-STD-414 is incorporated by reference
and has been approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
obtained from DODSSP, Standardization Document Order Desk, 700 Robbins
Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected
at the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the
Federal Register, 800 North Capitol Street NW., suite 700, Washington,
DC. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH,
Certification and Quality Assurance Branch, 1095 Willowdale Road,
Morgantown, WV 26505-2888. Incoming bulk raw material inspection or
verification of specification, and in-process inspection shall be
sufficient to ensure control of product quality through the
manufacturing cycle.
(c) The sampling procedure shall include a list of the
characteristics to be tested by the applicant or his agent.
(d) The characteristics listed in accordance with paragraph (c) of
this section shall be classified according to the potential effect of
such defect and grouped into the following classes:
(1) Critical. A defect that judgment and experience indicate is
likely to result in a condition immediately hazardous to life or health
for individuals using or depending upon the respirator;
(2) Major A. A defect, other than critical, that is likely to
result in failure to the degree that the respirator does not provide
any respiratory protection, or a defect that reduces protection and is
not detectable by the user;
(3) Major B. A defect, other than Major A or critical, that is
likely to result in reduced respiratory protection, and is detectable
by the user; and
(4) Minor. A defect that is not likely to materially reduce the
usability of the respirator for its intended purpose, or a defect that
is a departure from established standards and has little bearing on the
effective use or operation of the respirator.
(e) The quality control inspection test method to be used by the
applicant or his agent for each characteristic required to be tested
shall be described in detail.
(f) Each item manufactured shall be 100 percent inspected for
defects in all critical characteristics and all defective items shall
be rejected.
(g) The Acceptable Quality Level (AQL) for each major or minor
defect so classified by the applicant shall be:
(1) Major A. 1.0 percent;
(2) Major B. 2.5 percent; and
(3) Minor. 4.0 percent.
(h) Except as provided in paragraph (i) of this section, inspection
level IV as described in MIL-STD-414, 11 June 1957, including Change
Notice No.1, ``Sampling Procedures and Tables for Inspection by
Variables for Percent Defective,'' or an equivalent procedure, shall be
used for major and minor characteristics and 100 percent inspection for
critical characteristics. Inspection level II as described in MIL-STD-
105D, 29 April 1963, ``Sampling Procedures and Tables for Inspection by
Attributes,'' is an example of an equivalent procedure.
(i) Subject to the approval of the Institute, where the quality
control plan provisions for raw material, processes, manufacturing, and
fabrication, inspections are adequate to ensure control of finished
article quality, destructive testing of finished articles may be
conducted at a lower level of inspection than that specified in
paragraph (h) of this section.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Sec. 84.42 Proposed quality control plans; approval by the Institute.
(a) Each proposed quality control plan submitted in accordance with
this subpart shall be reviewed by the Institute to determine its
effectiveness in ensuring the quality of respiratory protection
provided by the respirator for which an approval is sought.
(b) If the Institute determines that the proposed quality control
plan submitted by the applicant will not ensure adequate quality
control, the Institute shall require the applicant to modify the
procedures and testing requirements of the plan prior to approval of
the plan and issuance of any certificate of approval.
(c) Approved quality control plans shall constitute a part of and
be incorporated into any certificate of approval issued by the
Institute, and compliance with such plans by the applicant shall be a
condition of approval.
Sec. 84.43 Quality control records; review by the Institute;
revocation of approval.
(a) The applicant shall keep quality control inspection records
sufficient to carry out the procedures required in MIL-STD-414, 11 June
1957, including Change Notice No. 1, ``Sampling Procedures and Tables
for Inspection by Variables for Percent Defective,'' or an approved
equivalent sampling procedure. MIL-STD-105D, 29 April 1963, ``Sampling
Procedures and Tables for Inspection by Attributes,'' is an example of
an approved equivalent sampling procedure. MIL-STD-414 is incorporated
by reference and has been approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from DODSSP, Standardization Document Order Desk, 700
Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch,
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC. Copies of MIL-STD-105D may be inspected or obtained
from the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888.
(b) The Institute reserves the right to have its representatives
inspect the applicant's quality control test methods, equipment, and
records, and to interview any employee or agent of the applicant in
regard to quality control test methods, equipment, and records.
(c) The Institute reserves the right to revoke, for cause, any
certificate of approval where it is found that the applicant's quality
control test methods, equipment, or records do not ensure effective
quality control over the respirator for which the approval was issued.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Subpart F--Classification of Approved Respirators; Scope of
Approval; Atmospheric Hazards; Service Time
Sec. 84.50 Types of respirators to be approved; scope of approval.
Approvals shall be issued for the types of respirators which have
been classified pursuant to this subpart F, have been inspected,
examined and tested by the Institute, in accordance with the provisions
of subparts G through L of this part, and have been found to provide
respiratory protection for fixed periods of time against the hazards
specified in such approval.
Sec. 84.51 Entry and escape, or escape only; classification.
Respirators described in subparts H through L of this part shall be
classified for use as follows:
(a) Entry and escape. Respirators designed and approved for use
during [[Page 30362]] entry into a hazardous atmosphere, and for escape
from a hazardous atmosphere; or
(b) Escape only. Respirators designed and approved for use only
during escape from a hazardous atmosphere.
Sec. 84.52 Respiratory hazards; classification.
Respirators described in subparts H through L of this part shall be
classified as approved for use against any or all of the following
respiratory hazards:
(a) Oxygen deficiency;
(b) Gases and vapors; and
(c) Particles, including dusts, fumes and mists.
Sec. 84.53 Service time; classification.
(a) Respirators described in subparts H through L of this part
shall be classified, where applicable, as approved for use during the
following prescribed service times:
(1) Four hours;
(2) Three hours;
(3) Two hours;
(4) One hour;
(5) Forty-five minutes;
(6) Thirty minutes;
(7) Fifteen minutes;
(8) Ten minutes;
(9) Five minutes; or
(10) Three minutes.
(b) Other service times may be prescribed by the Institute.
Subpart G--General Construction and Performance Requirements
Sec. 84.60 Construction and performance requirements; general.
(a) The Institute shall issue approvals for the types of
respirators described in subparts H through L of this part which have
met the minimum requirements set forth for such respirators in this
part.
(b) In addition to the types of respirators specified in subparts H
through L of this part, the Institute shall issue approvals for other
respiratory protective devices not specifically described in this part
subject to such additional requirements as may be imposed in accordance
with Sec. 84.63(c).
Sec. 84.61 General construction requirements.
(a) Respirators will not be accepted by the Institute for
examination, inspection and testing unless they are designed on sound
engineering and scientific principles, constructed of suitable
materials and evidence good workmanship.
(b) Respirator components which come into contact with the wearer's
skin shall be made of nonirritating materials.
(c) Components replaced during or after use shall be constructed of
materials which will not be damaged by normal handling.
(d) Mouthpieces, hoods, helmets, and facepieces, except those
employed in single-use respirators, shall be constructed of materials
which will withstand repeated disinfection as recommended by the
applicant in his instructions for use of the device.
Sec. 84.62 Component parts; minimum requirements.
(a) The component parts of each respirator shall be:
(1) Designed, constructed, and fitted to insure against creation of
any hazard to the wearer;
(2) Assembled to permit easy access for inspection and repair of
functional parts; and
(3) Assembled to permit easy access to parts which require periodic
cleaning and disinfecting.
(b) Replacement parts shall be designed and constructed to permit
easy installation and to maintain the effectiveness of the respirator.
Sec. 84.63 Test requirements; general.
(a) Each respirator and respirator component shall when tested by
the applicant and by the Institute, and meet the applicable
requirements set forth in subparts H through L of this part.
(b) Where a combination respirator is assembled from two or more
types of respirators, as described in this part, each of the individual
respirator types which have been combined shall, as applicable, meet
the minimum requirements for such respirators set forth in subparts H
through L of this part, and such combination respirators, except as
specified in Sec. 84.70(b)(2), will be classified by the type of
respirator in the combination which provides the least protection to
the user.
(c) In addition to the minimum requirements set forth in subparts H
through L of this part, the Institute reserves the right to require, as
a further condition of approval, any additional requirements deemed
necessary to establish the quality, effectiveness, and safety of any
respirator used as protection against hazardous atmospheres.
(d) Where it is determined after receipt of an application that
additional requirements will be required for approval, the Institute
will notify the applicant in writing of these additional requirements,
and necessary examinations, inspections, or tests, stating generally
the reasons for such requirements, examinations, inspections, or tests.
Sec. 84.64 Pretesting by applicant; approval of test methods.
(a) Prior to making or filing any application for approval or
modification of approval, the applicant shall conduct, or cause to be
conducted, examinations, inspections, and tests of respirator
performance which are equal to or exceed the severity of those
prescribed in this part.
(b) With the application, the applicant shall provide a statement
to the Institute showing the types and results of the examinations,
inspections, and tests required under paragraph (a) of this section and
state that the respirator meets the minimum requirements of subparts H
through L of this part, as applicable. Complete examination,
inspection, and test data shall be retained on file by the applicant
and be submitted, upon request, to the Institute.
(c) The Institute may, upon written request by the applicant,
provide drawings and descriptions of its test equipment and otherwise
assist the applicant in establishing a test laboratory or securing the
services of a testing agency.
(d) No approval will be issued until the Institute has validated
the applicant's test results.
Sec. 84.65 Conduct of examinations, inspections, and tests by the
Institute; assistance by applicant; observers; recorded data; public
demonstrations.
(a) All examinations, inspections, and tests conducted pursuant to
subparts H through L of this part will be under the sole direction and
control of the Institute.
(b) The Institute may, as a condition of approval, require the
assistance of the applicant or agents of the applicant during the
assembly, disassembly, or preparation of any respirator or respirator
component prior to testing or in the operation of such equipment during
testing.
(c) Only Institute personnel, persons assisting the Institute
pursuant to paragraph (b) of this section, and such other persons as
are requested by the Institute or the applicant to be observers, shall
be present during any examination, inspection, or test conducted prior
to the issuance of an approval by the Institute for the equipment under
consideration.
(d) The Institute shall hold as confidential any analyses,
drawings, specifications, or materials submitted by the applicant and
shall not disclose any principles or patentable features of such
equipment, except as required by statute or regulation.
(e) As a condition of each approval issued for any respirator, the
Institute [[Page 30363]] reserves the right, following the issuance of
such approval, to conduct such public tests and demonstrations of the
approved respiratory equipment as is deemed appropriate.
Sec. 84.66 Withdrawal of applications; refund of fees.
(a) Any applicant may, upon a written request submitted to the
Institute, withdraw any application for approval of any respirator.
(b) Upon receipt of a written request for the withdrawal of an
application, the Institute shall determine the total man-days expended
and the amount due for services already performed during the course of
any examinations, inspections, or tests conducted pursuant to such
application. The total amount due shall be determined in accordance
with the provisions of Sec. 84.22 and assessed against the fees
submitted by the applicant. If the total amount assessed is less than
the fees submitted, the Institute shall refund the balance together
with a statement of the charges made for services rendered.
Subpart H--Self-Contained Breathing Apparatus
Sec. 84.70 Self-contained breathing apparatus; description.
(a) Self-contained breathing apparatus, including all completely
assembled, portable, self-contained devices designed for use as
respiratory protection during entry into and escape from or escape only
from hazardous atmospheres, are described as follows:
(1) Closed-circuit apparatus. An apparatus of the type in which the
exhalation is rebreathed by the wearer after the carbon dioxide has
been effectively removed and a suitable oxygen concentration restored
from sources composed of:
(i) Compressed oxygen; or
(ii) Chemical oxygen; or
(iii) Liquid-oxygen.
(2) Open-circuit apparatus. An apparatus of the following types
from which exhalation is vented to the atmosphere and not rebreathed:
(i) Demand-type apparatus. An apparatus in which the pressure
inside the facepiece in relation to the immediate environment is
positive during exhalation and negative during inhalation; or
(ii) Pressure-demand-type apparatus. An apparatus in which the
pressure inside the facepiece in relation to the immediate environment
is positive during both inhalation and exhalation.
(b) The following respirators may be classified as designed and
approved for use during emergency entry into a hazardous atmosphere:
(1) A combination respirator which includes a self-contained
breathing apparatus; and
(2) A Type ``C'' or Type ``CE'' supplied air respirator, where--
(i) The self-contained breathing apparatus is classified for 3-, 5-
, or 10-minute service time and the air line supply is used during
entry; or
(ii) The self-contained breathing apparatus is classified for 15
minutes or longer service time and not more than 20 percent of the
rated capacity of the air supply is used during entry.
(c) Self-contained breathing apparatus classified for less than 1
hour service time will not be approved for use during underground mine
rescue and recovery operations except as auxiliary equipment.
(d) Self-contained breathing apparatus classified for less than 30
minutes' service time will not be approved for use as auxiliary
equipment during underground mine rescue and recovery operations.
Sec. 84.71 Self-contained breathing apparatus; required components.
(a) Each self-contained breathing apparatus described in Sec. 84.70
shall, where its design requires, contain the following component
parts:
(1) Facepiece or mouthpiece, and noseclip;
(2) Respirable breathing gas container;
(3) Supply of respirable breathing gas;
(4) Gas pressure or liquid level gages;
(5) Timer;
(6) Remaining service life indicator or warning device;
(7) Hand-operated valves;
(8) Breathing bag;
(9) Safety relief valve or safety relief system; and
(10) Harness.
(b) The components of each self-contained breathing apparatus shall
meet the minimum construction requirements set forth in subpart G of
this part.
Sec. 84.72 Breathing tubes; minimum requirements. Flexible breathing
tubes used in conjunction with breathing apparatus shall be designed
and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces and mouthpieces;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm
pressure.
Sec. 84.73 Harnesses; installation and construction; minimum
requirements.
(a) Each apparatus shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
apparatus in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of apparatus parts and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.74 Apparatus containers; minimum requirements.
(a) Apparatus may be equipped with a substantial, durable container
bearing markings which show the applicant's name, the type and
commercial designation of the respirator it contains, and all
appropriate approval labels.
(b) Containers supplied by the applicant for carrying or storing
self-contained breathing apparatus will be inspected, examined, and
tested as components of the respirator for which approval is sought.
(c) Containers for self-contained breathing apparatus shall be
designed and constructed to permit easy removal of the apparatus.
Sec. 84.75 Half-mask facepieces, full facepieces, mouthpieces; fit;
minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes,
either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for the optional use of
corrective spectacles or lenses which shall not reduce the respiratory
protective qualities of the apparatus.
(c) Apparatus with mouthpieces shall be equipped with noseclips
which are securely attached to the mouthpiece or apparatus and provide
an airtight seal.
(d) Facepieces shall be designed to prevent eyepiece, spectacle,
and lens fogging.
Sec. 84.76 Facepieces; eyepieces; minimum requirements.
(a) Facepieces shall be designed and constructed to provide
adequate vision which is not distorted by the eyepiece.
(b) All eyepieces shall be designed and constructed to be impact
and penetration resistant. Federal Specification, Mask, Air Line: and
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965
with interim amendment-1, July 30, 1969, is an example of an
appropriate standard for determining impact and penetration resistance.
Copies of GGG-M-125d may be obtained from the NIOSH, Certification and
Quality Assurance [[Page 30364]] Branch, 1095 Willowdale Road,
Morgantown, WV 26505-2888.
Sec. 84.77 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against damage and distortion.
(b) Exhalation valves shall be--
(1) Protected against external influence; and
(2) Designed and constructed to prevent inward leakage of
contaminated air.
Sec. 84.78 Head harnesses; minimum requirements.
(a) Facepieces shall be equipped with adjustable and replaceable
head harnesses designed and constructed to provide adequate tension
during suspension and an even distribution of pressure over the entire
area in contact with the face.
(b) Mouthpieces shall be equipped, where applicable, with
adjustable and replaceable harnesses designed and constructed to hold
the mouthpiece in place.
Sec. 84.79 Breathing gas; minimum requirements.
(a) Breathing gas used to supply apparatus shall be respirable and
contain no less than 19.5 (dry atmosphere) volume percent of oxygen.
(b) Oxygen, including liquid oxygen, shall contain not less than
99.0 percent, by volume, of pure O2, not more than 0.03%, by
volume, carbon dioxide, and not more than 0.001%, by volume, carbon
monoxide. Methods for making these determinations can be found in the
U.S. Pharmacopeia National Formulary. Containers used for oxygen must
not be treated with any toxic, sleep-inducing, narcosis-producing, or
respiratory tract irritating compounds.
(c) Compressed, gaseous breathing air shall meet the applicable
minimum grade requirements for Type I gaseous air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade D or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
American National Standards Institute, Inc., 1430 Broadway, New York,
NY 10018. Copies may be inspected at the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888, or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(d) Compressed, liquefied breathing air shall meet the applicable
minimum grade requirements for Type II liquid air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade B or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
American National Standards Institute, Inc., 1430 Broadway, New York,
NY 10018. Copies may be inspected at the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888, or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
Sec. 84.80 Interchangeability of oxygen and air prohibited.
Approvals shall not be issued by the Institute for any apparatus,
combination of respirator assemblies, or any apparatus or respirator
component which is designed or constructed to permit the
interchangeable use of oxygen and air.
Sec. 84.81 Compressed breathing gas and liquefied breathing gas
containers; minimum requirements.
(a) Compressed breathing gas and liquefied breathing gas containers
shall meet the minimum requirements of the Department of Transportation
for interstate shipment of such containers when fully charged.
(b) Such containers shall be permanently and legibly marked to
identify their contents, e.g., compressed breathing air, compressed
breathing oxygen, liquefied breathing air, or liquefied breathing
oxygen.
(c) Containers normally removed from apparatus for refilling shall
be equipped with a dial indicating gage which shows the pressure in the
container.
(d) Compressed breathing gas contained valves or a separate
charging system or adapter provided with each apparatus shall be
equipped with outlet threads specified for the service by the American
Standards Association, Compressed Gas Cylinder Valve Outlet and Inlet
Connections, B57.1-1965. B57.1-1965 is incorporated by reference and
has been approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
American National Standards Institute, Inc., 1430 Broadway, New York,
NY Copies may be inspected at the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
Sec. 84.82 Gas pressure gages; minimum requirements.
(a) Gas pressure gages employed on compressed breathing gas
containers shall be calibrated in pounds per square inch.
(b) Liquid-level gages shall be calibrated in fractions of total
container capacity, or in units of liquid volume.
(c) Gas pressure gages other than those specified in paragraphs (a)
and (b) of this section shall be calibrated in:
(1) Pounds per square inch; or
(2) In fractions of total container capacity; or
(3) Both in pounds per square inch and fractions of total container
capacity.
(d)(1) Dial-indicating gages shall be reliable to within
5 percent of full scale when tested both up and down the
scale at each of 5 equal intervals.
(2) The full-scale graduation of dial-indicating gages shall not
exceed 150 percent of the maximum rated cylinder pressures specified
for the container in applicable Department of Transportation
specifications or permits.
(e)(1) Stem-type gages shall be readable by sight and by touch and
shall have a stem travel distance of not less than one-fourth inch
between each graduation.
(2) A minimum of five graduations shall be engraved on the stem of
each gage and these graduations shall include readings for empty, one-
quarter, one-half, three-quarters, and full.
(3) Stem gage readings shall not vary from true readings by more
than one-sixteenth inch per inch of stem travel.
(f) The loss of gas through a broken gage or severed gage
connection shall not exceed 70 liters per minute when the cylinder
pressure is 6,900 kN/m.2 (1,000 pounds per square inch gage) or
when the liquid level is at one-half.
(g) Where gages are connected to the apparatus through a gage line,
the gage and line shall be capable of being isolated from the apparatus
except where the failure of the gage or line would not impair the
performance or service life of the apparatus.
(h) Oxygen pressure gages shall have the words ``Oxygen'' and ``Use
No Oil'' marked prominently on the gage.
(i)(1) Apparatus using compressed breathing gas, except apparatus
classified for escape only, shall be equipped with gages visible to the
wearer which indicate the remaining gas content in the container.
(2) Apparatus using liquefied breathing gas, except apparatus
classified for escape only, shall be equipped with gages visible to the
wearer which indicate the remaining liquid content in the container;
[[Page 30365]] however, where the liquid content cannot be rapidly
vented, and the service time of the device begins immediately after
filling, a timer shall be provided in place of a visible gage.
Sec. 84.83 Timers; elapsed time indicators; remaining service life
indicators; minimum requirements.
(a) Elapsed time indicators shall be provided for apparatus with a
chemical oxygen source, except:
(1) Apparatus used for escape only; or
(2) Liquefied breathing gas apparatus equipped with gages visible
to the wearer which indicate the remaining liquid content in the
container.
(b) The timer or other indicator shall be accurately calibrated in
minutes of remaining service life.
(c) Timers shall be readable by sight and by touch during use by
the wearer.
(d) Timers shall be equipped with automatically preset alarms which
will warn the wearer for a period of 7 seconds or more after the preset
time has elapsed.
(e) Remaining service-life indicators or warning devices shall be
provided in addition to a pressure gage on compressed gas self-
contained breathing apparatus, except apparatus used for escape only,
and shall operate automatically without preadjustment by the wearer.
(f) Each remaining service-life indicator or warning device shall
give an alarm when the remaining service life of the apparatus is
reduced within a range of 20 to 25 percent of its rated service time.
Sec. 84.84 Hand-operated valves; minimum requirements.
(a) Hand-operated valves shall be designed and constructed to
prevent removal of the stem from the valve body during normal usage to
insure against a sudden release of the full pressure of the container
when the valve is opened.
(b) Valves shall be designed or positioned to prevent accidental
opening and closing, and damage from external forces.
(c) Valves operated during use of the apparatus shall be installed
in locations where they can be readily adjusted by the wearer.
(d) Main-line valves, designed and constructed to conserve gas in
the event of a regulator or demand valve failure, shall be provided in
addition to gas container valves, except when such failure will not
affect performance.
(e) Hand-operated bypass systems designed and constructed to permit
the wearer to breathe and to conserve his gas supply in the event of a
regulator or demand valve failure, shall be provided where necessary.
(f) Valves installed on apparatus shall be clearly distinguishable
from one another by sight and touch.
(g) The bypass system valve control shall be colored red.
(h) A main-line or bypass valve or system will not be required on
apparatus for escape only.
(i) Safety relief valves or systems, designed and constructed to
release excess pressure in the breathing circuit, shall be provided on
closed-circuit apparatus, and shall meet the following requirements:
(1) The relief valve or system shall operate automatically when the
pressure in the breathing circuit on the inhalation side of the
breathing bag reaches 13 mm. (one-half inch) water-column height of
pressure above the minimum pressure required to fill the breathing bag,
within the breathing resistance requirements for the apparatus.
(2) The relief valve or system shall be designed to prevent
external atmospheres from entering the breathing circuit.
(3) The relief valve or system shall be designed to permit manual
overriding for test purposes and in the event of a failure in the valve
or system.
Sec. 84.85 Breathing bags; minimum requirements.
(a) Breathing bags shall have sufficient volume to prevent gas
waste during exhalation and to provide an adequate reserve for
inhalation.
(b) Breathing bags shall be constructed of materials which are
flexible and resistant to gasoline vapors.
(c) Breathing bags shall be installed in a location which will
protect them from damage or collapse by external forces, except on
apparatus classified for escape only.
Sec. 84.86 Component parts exposed to oxygen pressures; minimum
requirements.
Each applicant shall certify that the materials employed in the
construction of component parts exposed to oxygen pressures above
atmospheric pressure are safe and compatible for their intended use.
Sec. 84.87 Compressed gas filters; minimum requirements.
All self-contained breathing apparatus using compressed gas shall
have a filter downstream of the gas source to effectively remove
particles from the gas stream.
Sec. 84.88 Breathing bag test.
(a) Breathing bags will be tested in an air atmosphere saturated
with gasoline vapor at room temperature (24-30 deg.C./75-85 deg.F.)
for a continuous period of twice the rated time of the apparatus
(except for apparatus for escape only where the test period shall be
the rated time of the apparatus).
(b) The bag will be operated during this test by a breathing
machine with 24 respirations per minute and a minute-volume of 40
liters.
(c) A breathing machine cam with a work rate of 622 kp.-m./min.
will be used. The dimensions of a suitable breathing machine cam are
available from the Institute upon request.
(d) The air within the bag(s) shall not contain more than 100 parts
per million of gasoline vapor at the end of the test.
Sec. 84.89 Weight requirement.
(a) The completely assembled and fully charged apparatus shall not
weigh more than 16 kg. (35 pounds); however, where the weight decreases
by more than 25 percent of its initial charge weight during its rated
service life, the maximum allowable weight of a completely assembled
and fully charged apparatus shall be 18 kg. (40 pounds).
(b) Where an apparatus employs equipment which contributes
materially to the wearer's comfort, e.g., a cooling system, the
completely assembled and fully charged apparatus shall not weigh more
than 18 kg. (40 pounds) regardless of the decrease in weight during
use.
Sec. 84.90 Breathing resistance test; inhalation.
(a) Resistance to inhalation airflow will be measured in the
facepiece or mouthpiece while the apparatus is operated by a breathing
machine as described in Sec. 84.88.
(b) The inhalation resistance of open-circuit apparatus shall not
exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120
liters per minute).
(c) The inhalation resistance of closed-circuit apparatus shall not
exceed the difference between exhalation resistance (Sec. 84.91(e)) and
10 cm. (4 inches) water-column height.
Sec. 84.91 Breathing resistance test; exhalation.
(a) Resistance to exhalation airflow will be measured in the
facepiece or mouthpiece of open-circuit apparatus with air flowing at a
continuous rate of 85 liters per minute.
(b) The exhalation resistance of demand apparatus shall not exceed
25 mm. (1 inch) water-column height.
(c) The exhalation resistance of pressure-demand apparatus shall
not exceed the static pressure in the facepiece by more than 51 mm. (2
inches) water-column height.
(d) The static pressure (at zero flow) in the facepiece shall not
exceed 38 mm. (1.5 inches) water-column height. [[Page 30366]]
(e) Resistance to exhalation airflow will be measured in the
facepiece or mouthpiece of closed-circuit apparatus with a breathing
machine as described in Sec. 84.88, and the exhalation resistance shall
not exceed 51 mm. (2 inches) water-column height.
Sec. 84.92 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. (1 inch) water-column height while in a normal
operating position.
(b) Leakage between the valve and the valve seat shall not exceed
30 milliliters per minute.
Sec. 84.93 Gas flow test; open-circuit apparatus.
(a) A static-flow test will be performed on all open-circuit
apparatus.
(b) The flow from the apparatus shall be greater than 200 liters
per minute when the pressure in the facepiece of demand-apparatus is
lowered by 51 mm. (2 inches) water-column height when full container
pressure is applied.
(c) Where pressure demand apparatus are tested, the flow will be
measured at zero gage pressure in the facepiece.
(d) Where apparatus with compressed-breathing-gas containers are
tested, the flow test shall also be made with 3,450 kN/m.\2\ (500
p.s.i.g.) container pressure applied.
Sec. 84.94 Gas flow test; closed-circuit apparatus.
(a) Where oxygen is supplied by a constant-flow device only, the
rate of flow shall be at least 3 liters per minute for the entire rated
service time of the apparatus.
(b) Where constant flow is used in conjunction with demand flow,
the constant flow shall be greater than 1.5 liters per minute for the
entire rated service time.
(c) All demand-flow devices shall provide at least 30 liters of
oxygen per minute when in the fully open position.
Sec. 84.95 Service time test; open-circuit apparatus.
(a) Service time will be measured with a breathing machine as
described in Sec. 84.88.
(b) The open-circuit apparatus will be classified according to the
length of time it supplies air or oxygen to the breathing machine.
(c) The service time obtained on this test will be used to classify
the open-circuit apparatus in accordance with Sec. 84.53.
Sec. 84.96 Service time test; closed-circuit apparatus.
(a) The closed-circuit apparatus will be classified according to
the length of time it supplies adequate breathing gas to the wearer
during man test No. 4 described in Table 4 of this subpart.
(b) The service time obtained on man test No. 4 will be used to
classify the closed-circuit apparatus in accordance with Sec. 84.53.
Sec. 84.97 Test for carbon dioxide in inspired gas; open- and closed-
circuit apparatus; maximum allowable limits.
(a) Open-circuit apparatus:
(1) The concentration of carbon dioxide in inspired gas in open-
circuit apparatus will be measured at the mouth while the apparatus
mounted on a dummy head is operated by a breathing machine. An
acceptable method for measuring the concentration of carbon dioxide is
described in Bureau of Mines Report of Investigations 6865, A Machine-
Test Method for Measuring Carbon Dioxide in the Inspired Air of Self-
Contained Breathing Apparatus, 1966. Copies of Report of Investigations
6865 may be inspected or obtained from the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV. 26505-
2888.
(2) The breathing rate will be 14.5 respirations per minute with a
minute-volume of 10.5 liters.
(3) A sedentary breathing machine cam will be used.
(4) The apparatus will be tested at a temperature of 27
2 deg. C. (80 5 deg. F.).
(5) A concentration of 5 percent carbon dioxide in air will be
exhaled into the facepiece.
(b) Closed-circuit apparatus. The concentration of carbon dioxide
in inspired gas in closed-circuit apparatus will be measured at the
mouth while the parts of the apparatus contributing to dead-air space
are mounted on a dummy head and operated by the breathing machine as in
paragraphs (a) (1) through (5) of this section.
(c) During the testing required by paragraphs (a) and (b) of this
section, the concentration of carbon dioxide in inspired gas at the
mouth will be continuously recorded, and the maximum average
concentration during the inhalation portion of the breathing cycle
shall not exceed the following limits:
------------------------------------------------------------------------
Maximum allowable
average concentration
Where the service time is of carbon dioxide in
inspired air percent by
volume
------------------------------------------------------------------------
Not more than 30 minutes....................... 2.5
1 hour......................................... 2.0
2 hours........................................ 1.5
3 hours........................................ 1.0
4 hours........................................ 1.0
------------------------------------------------------------------------
(d) In addition to the test requirements for closed-circuit
apparatus set forth in paragraph (b) of this section, gas samples will
be taken during the course of the man tests described in Tables 1, 2,
3, and 4 of this subpart. These gas samples will be taken from the
closed-circuit apparatus at a point downstream of the carbon dioxide
sorbent, and they shall not contain more than 0.5 percent carbon
dioxide at any time, except on apparatus for escape only, using a
mouthpiece only, the sample shall not contain more than 1.5 percent
carbon dioxide at any time.
Sec. 84.98 Tests during low temperature operation.
(a) The applicant shall specify the minimum temperature for safe
operation and two persons will perform the tests described in
paragraphs (c) and (d) of this section, wearing the apparatus according
to applicant's directions. At the specified temperature, the apparatus
shall meet all the requirements described in paragraph (e) of this
section.
(b) The apparatus will be precooled at the specified minimum
temperature for 4 hours.
(c) The apparatus will be worn in the low temperature chamber for
30 minutes, or for the service time of the apparatus, whichever is
less.
(d) During the test period, alternate 1-minute periods of exercise
and rest will be required with the exercise periods consisting of
stepping onto and off a box 21.5 cm. (8\1/2\ inches) high at a rate of
30 cycles per minute.
(e)(1) The apparatus shall function satisfactorily at the specified
minimum temperature on duplicate tests.
(2) The wearer shall have sufficient unobscured vision to perform
the work.
(3) The wearer shall not experience undue discomfort because of
airflow restriction or other physical or chemical changes in the
operation of the apparatus.
(f) Auxiliary low-temperature parts which are commercially
available to the user may be used on the apparatus to meet the
requirements described in paragraph (e) of this section.
Sec. 84.99 Man tests; testing conditions; general requirements.
(a) The man tests described in Tables 1, 2, 3, and 4 of this
subpart represent the workload performed in the mining, mineral, or
allied industries by a person wearing the apparatus tested.
(b) The apparatus tested will be worn by Institute personnel
trained in the use of self-contained breathing apparatus, and the
wearer will, before participating in these tests, pass a physical
[[Page 30367]] examination conducted by a qualified physician.
(c) All man tests will be conducted by the Institute.
(d) The apparatus will be examined before each man test to ensure
that it is in proper working order.
(e) Breathing resistance will be measured within the facepiece or
mouthpiece and the wearer's pulse and respiration rate will be recorded
during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.
(f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.
(g) If man tests are not completed through no fault of the
apparatus, the test will be repeated.
Sec. 84.100 Man tests 1, 2, 3, and 4; requirements.
Man tests 1, 2, 3, and 4, set forth in Tables 1, 2, 3, and 4 of
this subpart, respectively, prescribe the duration and sequence of
specific activities. These tests will be conducted to--
(a) Familiarize the wearer with the apparatus during use;
(b) Provide for a gradual increase in activity;
(c) Evaluate the apparatus under different types of work and
physical orientation; and
(d) Provide information on the operating and breathing
characteristics of the apparatus during actual use.
Sec. 84.101 Man test 5; requirements.
(a) Test 5 will be conducted to determine the maximum length of
time the apparatus will supply the respiratory needs of the wearer
while he is sitting at rest.
(b) The wearer will manipulate the devices controlling the supply
of breathing gas to the advantage of the apparatus.
(c) Samples of inspiration from within the apparatus facepiece or
mouthpiece shall be taken once every 15 minutes, and shall meet the
minimum requirement for oxygen specified in Sec. 84.79(a), and the
maximum allowable average concentration of carbon dioxide specified in
Sec. 84.97(c).
(d) One sample of inspiration will be taken in the case of 3-, 5-,
and 10-minute apparatus.
Sec. 84.102 Man test 6; requirements.
(a) Man test 6 will be conducted with respect to liquefied
breathing gas apparatus only.
(b) This test will be conducted to evaluate operation of the
apparatus in other than vertical positions.
(c) The wearer will lie face downward for one-fourth the service
life of the apparatus with a full charge of liquefied breathing gas,
and then a one-quarter full charge of liquefied breathing gas.
(d) The test will be repeated with the wearer lying on each side
and on his back.
(e) The oxygen content of the gas supplied to the wearer by the
apparatus will be continuously measured.
Sec. 84.103 Man tests; performance requirements.
(a) The apparatus shall satisfy the respiratory requirements of the
wearer for the classified service time.
(b) Fogging of the eyepiece shall not obscure the wearer's vision,
and the wearer shall not experience undue discomfort because of fit or
other characteristics of the apparatus.
(c) When the ambient temperature during testing is 246
deg.C. (7510 deg.F.), the maximum temperature of inspired
air recorded during man tests shall not exceed the following, after
correction for deviation from 24 deg.C. (75 deg.F.):
------------------------------------------------------------------------
Where percent Maximum permissible
relative temperature of inspired
Where service life of humidity of air shall not exceed--
apparatus is-- inspired air -------------------------
is-- deg.F. deg.C.
------------------------------------------------------------------------
\1/4\ hour or less............ 0-100 135 57
\1/4\ hour to \3/4\ hour...... 0-50
50-100 125
\1\ 110 52
\1\ 43
1 to 2 hours.................. 0-50
50-100 115
\1\105 46
\1\41
3 hours....................... 0-50
50-100 110
\1\100 43
\1\ 38
4 hours....................... 0-50
50-100 105
\1\ 95 41
\1\ 35
------------------------------------------------------------------------
\1\ Where percent relative humidity is 50-100 and apparatus is designed
for escape only, these maximum permissible temperatures will be
increased by 5 deg.C (10 deg.F).
Sec. 84.104 Gas tightness test; minimum requirements.
(a) Each apparatus will be tested for tightness by persons wearing
it in an atmosphere of 1,000 p.p.m. isoamyl acetate.
(b) Six persons will each wear the apparatus in the test
concentrations specified in paragraph (a) of this section for 2 minutes
and none shall detect the odor or taste of the test vapor.
Tables to Subpart H of Part 84
Table 1.--Duration and Sequence of Specific Activities for Test 1, in Minutes
[42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Service time--
------------------------------------------------------------------------------------------------------------
Activity 2, 3, and 4
3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings...................... ........... ........... ........... 2 2 2 2 Perform 1 hour
test 2, 3, or 4
times
respectively.
[[Page 30368]]
Walks at 4.8 km. (3 miles) per hour........ 3 5 3 4 8 12 18
Sampling and readings...................... ........... ........... 2 2 2 2 2
Walks at 4.8 km. (3 miles) per hour........ ........... ........... 3 5 8 12 18
Sampling and readings...................... ........... ........... 2 2 2 2 2 ................
Walks at 4.8 km. (3 miles) per hour........ ........... ........... ........... ........... 6 13 16
Sampling and readings...................... ........... ........... ........... ........... 2 2 2 ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2.--Duration and Sequence of Specific Activities For Test 2, in Minutes
[42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Service time--
----------------------------------------------------------------------------------------------------------------------
Activity 2, 3 and 4 hours
3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings............ ........... ........... ............. 2............ 2............ 2............ 2............ 2
Walks at 4.8 km. (3 miles) per ........... ........... 1............ 1............ 3............ 4............ 6............ 10.
hour.
Carries 23 kg. (50 pound) weight ........... ........... 1 time in 2 1 time in 2 2 times in 4 3 times in 6 4 times in 8 5 times in 10
over overcast. minutes. minutes. minutes. minutes. minutes. minutes.
Walks at 4.8 km. (3 miles) per ........... ........... ............. 1............ 3............ 3............ 3............ 5.
hour.
Climbs vertical treadmill \2\ (or 1 1 1............ 1............ 1............ 1............ 1............ 1.
equivalent).
Walks at 4.8 km. (3 miles) per ........... 1 1............ ............. ............. 2............ 3............ 5
hour.
Climbs vertical treadmill (or ........... 1 ............. ............. ............. 1............ 1............ 1.
equivalent).
Sampling and readings............ ........... ........... ............. ............. 2............ 2............ 2............ 2.
Walks at 4.8 km. (3 miles) per ........... ........... ............. 2............ 2............ 3............ 5............ 11.
hour.
Climbs vertical treadmill (or ........... ........... ............. 1............ 1............ 1............ 1............ 1.
equivalent).
Carries 23 kg. (50 pound) weight ........... ........... ............. 1 time in 2 3 times in 6 4 times in 8 5 times in 10 5 times in 10
over overcast. minutes. minutes. minutes. minutes. minutes.
Sampling and readings............ ........... ........... 2............ ............. ............. 2............ 2............ 2.
Walks at 4.8 km. (3 miles) per ........... ........... ............. 1............ 3............ 3............ 3............ ................
hour.
Climbs vertical treadmill (or ........... ........... 1............ 1............ 1............ 1............ 1............ Then repeat
equivalent). above
activities
once.
Walks at 4.8 km. (3 miles) per ........... ........... 2............ ............. ............. 2............ 3 ................
hour.
Climbs vertical treadmill (or ........... ........... ............. ............. ............. 1............ 1............ ................
equivalent).
Carries 20 kg. (45 pound) weight 1 ........... ............. ............. ............. ............. 2............ ................
and walks at 4.8 km. (3 miles)
per hour.
Walks at 4.8 km. (3 miles) per 1 2 ............. ............. ............. 1............ 4............ ................
hour.
Sampling and readings............ ........... ........... ............. 2............ 2............ 2............ 2............ ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 2 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.
\2\ Treadmill shall be inclined 15 deg. from vertical and operated at a speed of 1 foot per second.
[[Page 30369]]
Table 3.--Duration and Sequence of Specific Activities For Test 3, in Minutes
[42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Service time--
-------------------------------------------------------------------------------------------------------------------
Activity 2, 3 and 4
3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour hours \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings............... ........... ............. ............. 2............ 2............ 2............ 2............ (\2\)
Walks at 4.8 km. (3 miles) per hour. ........... ............. 1............ 1............ 2............ 2............ 3............ ...........
Runs at 9.7 km. (6 miles) per hour.. 1 1............ 1............ 1............ 1............ 1............ 1............ ...........
Pulls 20 kg. (45 pound) weight to 5 ........... 15 times in 1 ............. 30 times in 2 30 times in 2 30 times in 2 60 times in 6 ...........
feet. minute. minutes. minutes. minutes. minutes.
Lies on side........................ 1/2 1............ 1............ 2............ 3............ 4............ 5............ ...........
Lies on back........................ 1/2 1............ 1............ 2............ 2............ 3............ 3............ ...........
Crawls on hands and knees........... 1 1............ 1............ 2............ 2............ 2............ 2............ ...........
Sampling and readings............... ........... ............. 2............ ............. 2............ 2............ 2............ ...........
Runs at 9.7 km. (6 miles) per hour.. ........... ............. ............. 1............ 1............ 1............ 1............ ...........
Walks at 4.8 km. (3 miles) per hour. ........... ............. ............. ............. 2............ 8............ 10........... ...........
Pulls 20 kg. (45 pound) weight to 5 ........... ............. 30 times in 2 ............. 60 times in 6 60 times in 6 60 times in 6 ...........
feet. minutes. minutes. minutes. minutes.
Sampling and readings............... ........... ............. ............. 2............ ............. 2............ 2............ ...........
Walks at 4.8 km. (3 miles) per hour. ........... ............. 1............ ............. 3............ 4............ 10........... ...........
Lies on side........................ ........... ............. ............. ............. ............. 2............ 4............ ...........
Lies on back........................ ........... ............. ............. ............. ............. 2............ 1............ ...........
Sampling and readings............... ........... ............. ............. ............. 2............ 2............ 2............ ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 3 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.
\2\ Perform test No. 3 for 1 hr. apparatus; then perform test No. 1 for 1 hour apparatus.
[[Page 30370]]
Table 4.--Duration and Sequence of Specific Activities for Test 4, in Minutes
[42 CFR part 84, subpart H]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Service time--
Activity -----------------------------------------------------------------------------------------------------------------------------------------
3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour 2 hours 3 hours 4 hours
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings................................. ............. ............. ............. 2............ 2............ 2............ 2............ (\2\) (\3\) (\4\)
Walks at 4.8 km. (3 miles) per hour................... ............. ............. ............. 1............ 2............ 2............ 2............ ......... ......... .........
Climbs vertical treadmill \1\ (or equivalent)......... 1............ 1............ 1............ 1............ 1............ 1............ 1............ ......... ......... .........
Walks at 4.8 km. (3 miles) per hour................... ............. 1............ 1............ 1............ 2............ 2............ 2 ......... ......... .........
Pulls 20 kg. (45 pound) weight to 5 feet.............. ............. 30 times in 2 30 times in 2 30 times in 2 60 times in 5 60 times in 5 60 times in 5 ......... ......... .........
minutes. minutes. minutes. minutes. minutes. minutes.
Walks at 4.8 km. (3 miles) per hour................... ............. ............. 1............ 1............ 1............ 2............ 3............ ......... ......... .........
Carries 23 kg. (50 pound) weight over overcast........ ............. ............. ............. 1 time in 1 1 time in 1 2 times in 3 4 times in 8 ......... ......... .........
minute. minute. minutes. minutes.
Sampling and readings................................. ............. ............. 2............ ............. 2............ 2............ 2............ ......... ......... .........
Walks at 4.8 km. (3 miles) per hour................... ............. ............. ............. 1............ 3............ 3............ 4............ ......... ......... .........
Runs at 9.7 km. (6 miles) per hour.................... ............. 1............ 1............ 1............ 1............ 1............ 1............ ......... ......... .........
Carries 23 kg. (50 pound) weight over overcast........ ............. ............. 1 time in 1 1 time in 1 2 times in 3 4 times in 6 6 times in 9 ......... ......... .........
minute. minute. minutes. minutes. minutes.
Pulls 20 kg (45 pound) weight to 5 feet............... 15 times in 1 ............. ............. 15 times in 1 60 times in 5 30 times in 2 36 times in 3 ......... ......... .........
minute. minute. minutes. minutes. minutes.
Sampling and readings................................. ............. ............. ............. 2............ 2............ 2............ 2............ ......... ......... .........
Walks at 4.8 km. (3 miles) per hour................... 1............ ............. 1............ ............. ............. 2............ 6............ ......... .........
Pulls 20 kg. (45 pound) weight to 5 feet.............. ............. ............. ............. ............. ............. 60 times in 5 60 times in 5 ......... ......... .........
minutes. minutes.
Carries 20 kg. (45 pound) weight and walks at 4.8 km. ............. ............. ............. ............. ............. 3............ 3............ ......... ......... .........
(3 miles) per hour.
Sampling and readings................................. ............. ............. ............. ............. ............. 2............ 2............ ......... ......... .........
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Treadmill shall be inclined 15 deg. from vertical and operated at a speed of 30 cm. (1 foot) per second.
\2\ Perform test No. 1 for 30-minute apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 30-minute apparatus.
\3\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus.
\4\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus twice (i.e., two one-hour tests).
[[Page 30371]]
Subpart I--Gas Masks
Sec. 84.110 Gas masks; description.
(a) Gas masks including all completely assembled air purifying
masks designed for use as respiratory protection during entry into
atmospheres not immediately dangerous to life or health or escape only
from hazardous atmospheres containing adequate oxygen to support life
are described as follows:
(1) Front-mounted or back-mounted gas mask. A gas mask which
consists of a full facepiece, a breathing tube, a canister at the front
or back, a canister harness, and associated connections.
(2) Chin-style gas mask. A gas mask which consists of a full
facepiece, a canister which is usually attached to the facepiece, and
associated connections.
(3) Escape gas mask. A gas mask designed for use during escape only
from hazardous atmospheres which consists of a facepiece or mouthpiece,
a canister, and associated connections.
(b) Gas masks shall be further described according to the types of
gases or vapors against which they are designed to provide respiratory
protection, as follows:
Type of front-mounted or back-mounted gas mask:
Acid gas 1 2 3
Ammonia
Carbon monoxide
Organic Vapor 1 2 3
Other gas(es) and vapor(s) 1 2 3
Combination of two or more of the above gases and vapors.1 2 3
Combination of acid gas, ammonia, carbon monoxide, and organic
vapors.1 2 3
Type of chin-style gas mask:
Acid gas 1 2 3
Ammonia
Carbon monoxide
Organic vapor 1 2 3
Other gas(es) and vapor 1 2 3
Combination of two or more of the above gases and vapors.1 2 3
Type of escape gas mask:
Acid gas 1 2 3 4
Ammonia \4\
Carbon monoxide
Organic vapor 1 2 3 4
Other gas(s) and vapor(s) 1 2 3 4
Combination of two or more of the above gases and vapors. 1 2 3 4
\1\ Approval may be for acid gases or organic vapors as a class or for
specific acid gases or organic vapors.
\2\ Not for use against gases or vapors with poor warning properties
(except where MSHA or Occupational Safety and Health Administration
standards permit such use for a specific gas or vapor), or those which
generate high heats or reaction with sorbent materials in the
canister.
\3\ Use of the gas mask may be limited by factors such as lower
explosive limit, toxicological effects, and facepiece fit. Limitations
on gas mask service life and sorbent capacity limitations shall be
specified by the applicant in instructions for selection, use and
maintenance of the gas mask.
\4\ Eye protection may be required in certain concentrations of gases
and vapors.
(c) Gas masks for respiratory protection against gases and vapors
other than those specified in paragraph (b) of this section, may be
approved upon submittal of an application in writing for approval to
the Certification and Quality Assurance Branch listing the gas or vapor
and suggested maximum use concentration for the specific type of gas
mask. The Institute will consider the application and accept or reject
it on the basis of effect on the wearer's health and safety and any
field experience in use of gas masks for such exposures. If the
application is accepted, the Institute will test such masks in
accordance with the requirements of this subpart.
Sec. 84.111 Gas masks; required components.
(a) Each gas mask described in Sec. 84.110 shall, where its design
requires, contain the following component parts:
(1) Facepiece or mouthpiece and noseclip;
(2) Canister or cartridge;
(3) Canister harness;
(4) External check valve; and
(5) Breathing tube.
(b) The components of each gas mask shall meet the minimum
construction requirements set forth in subpart G of this part.
Sec. 84.112 Canisters and cartridges in parallel; resistance
requirements.
Where two or more canisters or cartridges are used in parallel,
their resistance to airflow shall be essentially equal.
Sec. 84.113 Canisters and cartridges; color and markings;
requirements.
The color and markings of all canisters and cartridges or labels
shall conform with the requirements of the American National Standards
Institute, American National Standard for Identification of Air-
Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI
K13.1 is incorporated by reference and has been approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be obtained from American National Standards
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch,
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
Sec. 84.114 Filters used with canisters and cartridges; location;
replacement.
(a) Particulate matter filters used in conjunction with a canister
or cartridge shall be located on the inlet side of the canister or
cartridge.
(b) Filters shall be incorporated in or firmly attached to the
canister or cartridge and each filter assembly shall, where applicable,
be designed to permit its easy removal from and replacement in the
canister or cartridge.
Sec. 84.115 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with gas masks shall
be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces or mouthpieces;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm
pressure.
Sec. 84.116 Harnesses; installation and construction; minimum
requirements.
(a) Each gas mask shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
gas mask in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of gas mask parts, and where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.117 Gas mask containers; minimum requirements.
(a) Gas masks shall be equipped with a substantial, durable
container bearing markings which show the applicant's name, the type
and commercial designation of mask it contains and all appropriate
approval labels.
(b) Containers for gas masks shall be designed and constructed to
permit easy removal of the mask.
Sec. 84.118 Half-mask facepieces, full facepieces, and mouthpieces;
fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or [[Page 30372]] lenses, which shall not reduce the
respiratory protective qualities of the gas mask.
(c) Half-mask facepieces shall not interfere with the fit of common
industrial safety spectacles, as determined by the Institute's
facepiece tests in Sec. 84.124.
(d) Gas masks with mouthpieces shall be equipped with noseclips
which are securely attached to the mouthpiece or gas mask and provide
an airtight seal.
(e) Facepieces shall be designed to prevent eyepiece fogging.
Sec. 84.119 Facepieces; eyepieces; minimum requirements.
(a) Full facepieces shall be designed and constructed to provide
adequate vision which is not distorted by the eye.
(b) All eyepieces shall be designed and constructed to be impact
and penetration resistant. Federal Specification, Mask, Air Line: and
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965
with interim amendment-1, July 30, 1969, is an example of an
appropriate standard for determining impact and penetration resistance.
Copies of GGG-M-125d may be obtained from the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
Sec. 84.120 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against damage and distortion.
(b) Inhalation valves shall be designed and constructed to prevent
excessive exhaled air from adversely affecting cartridges, canisters,
and filters.
(c) Exhalation valves shall be protected against external
influence, and designed and constructed to prevent inward leakage of
contaminated air.
Sec. 84.121 Head harnesses; minimum requirements.
(a) Facepieces shall be equipped with adjustable and replaceable
head harnesses, designed and constructed to provide adequate tension
during use and an even distribution of pressure over the entire area in
contact with the face.
(b) Mouthpieces shall be equipped, where applicable, with
adjustable and replaceable harnesses designed and constructed to hold
the mouthpiece in place.
Sec. 84.122 Breathing resistance test; minimum requirements.
(a) Resistance to airflow will be measured in the facepiece or
mouthpiece of a gas mask mounted on a breathing machine both before and
after each test conducted in accordance with Secs. 84.124, 84.125, and
84.126, with air flowing at a continuous rate of 85 liters per minute.
(b) The maximum allowable resistance requirements for gas masks are
as follows:
Maximum Resistance
[mm. water-column height]
------------------------------------------------------------------------
Inhalation
Type of gas mask -------------------------- Exhalation
Initial Final \1\
------------------------------------------------------------------------
Front-mounted or back-mounted
(without particulate filter).... 60 75 20
Front-mounted or back-mounted
(with approved particulate
filter)......................... 70 85 20
Chin-style (without particulate
filter)......................... 40 55 20
Chin-style (with approved
particulate filter)............. 65 80 20
Escape (without particulate
filter)......................... 60 75 20
Escape (with approved particulate
filter)......................... 70 85 20
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Tables 5, 6, and 7
of this subpart.
Sec. 84.123 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Sec. 84.124 Facepiece tests; minimum requirements.
(a) The complete gas mask will be fitted to the faces of persons
having varying facial shapes and sizes.
(b) Where the applicant specifies a facepiece size or sizes for the
gas mask, together with the approximate measurements of faces they are
designed to fit, the Institute will insure that test subjects suit such
facial measurements.
(c) Any gas mask parts which must be removed to perform the
facepiece or mouthpiece fit test shall be replaceable without special
tools and without disturbing the facepiece or mouthpiece fit.
(d) The facepiece or mouthpiece fit test, using positive or
negative pressure recommended by the applicant and described in his
instructions will be used before each test specified in paragraph (e)
of this section, and in Sec. 84.125.
(e)(1) Each wearer will enter a chamber containing 100 p.p.m.
isoamyl acetate vapor for a half-mask facepiece and 1,000 p.p.m.
isoamyl acetate vapor for a full facepiece or mouthpiece.
(2) The facepiece or mouthpiece may be adjusted, if necessary, in
the test chamber before starting the tests.
(3) Each wearer will remain in the chamber for 8 minutes while
performing the following activities:
(i) Two minutes, nodding and turning head;
(ii) Two minutes, calisthenic arm movements;
(iii) Two minutes, running in place; and
(iv) Two minutes, pumping with a tire pump into a 28 liter (1 cubic
foot) container.
(4) Each wearer shall not detect the odor of isoamyl acetate during
the test.
Sec. 84.125 Particulate tests; canisters containing particulate
filters; minimum requirements.
Gas mask canisters containing filters for protection against
particulates (e.g. dusts, fumes, mists, and smokes) in combination with
gases, vapors, or gases and vapors, shall also comply with the
requirements as prescribed in Secs. 84.170 through 84.183, except for
the airflow resistance test of Sec. 84.181.
Sec. 84.126 Canister bench tests; minimum requirements.
(a)(1) Bench tests, except for carbon monoxide tests, will be made
on an apparatus that allows the test atmosphere at 505
percent relative humidity and room temperature (252.5
deg.C.) to enter the canister continuously at concentrations and rates
of flow [[Page 30373]] specified in Tables 5, 6, and 7 of this subpart.
(2) Three canisters will be removed from containers and tested as
received from the applicant.
(3) Two canisters, other than those described in paragraph (a)(2)
of this section, will be equilibrated at room temperature by passing 25
percent relative humidity air through them at 64 liters per minute for
6 hours.
(4) Two canisters, other than those described in paragraphs (a) (2)
and (3) of this section, will be equilibrated at room temperature by
passing 85 percent relative humidity air through them at 64 liters per
minute for 6 hours.
(5) The equilibrated canisters will be resealed, kept in an upright
position at room temperature, and tested within 18 hours.
(b) Front-mounted and back-mounted gas mask canisters will be
tested and shall meet the minimum requirements set forth in Table 5 of
this subpart.
(c)(1) Front-mounted, and back-mounted, and chin-style canisters
designated as providing respiratory protection against gases, ammonia,
organic vapors, carbon monoxide and particulate contaminants shall have
a window or other indicator to warn the gas mask wearer when the
canister will no longer satisfactorily remove carbon monoxide from the
inhaled air.
(2) Other types of front- and back-mounted canisters may also be
equipped with a window or other indicator to warn of imminent leakage
of other gases or vapors.
(3) The window indicator canisters will be tested as regular
canisters, but shall show a satisfactory indicator change or other
warning before the allowable canister penetration has occurred.
(d) Chin-style gas mask canisters shall meet the minimum
requirements set forth in Table 6 of this subpart.
(e) Escape gas mask canisters shall meet the minimum requirements
set forth in Table 7 of this subpart.
Tables to Subpart I of Part 84
Table 5.--Canister Bench Tests and Requirements for Front-Mounted and Back-Mounted Gas Mask Canisters
[42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
---------------------------------------- Maximum
Flow rate Number of allowable Minimum
Canister type Test condition Concentration (liters tests penetratin service life
Gas or vapor (parts per per (parts per (minutes)
million) minute) million) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................................. As received SO2 20,000 64 3 5 12
Equilibrated Cl2 20,000 64 3 5 12
.................... SO2 20,000 32 4 5 12
.................... Cl2 20,000 32 4 5 12
Organic vapor........................................ As received CCl4 20,000 64 3 5 12
Equilibrated CCl4 20,000 32 4 5 12
Ammonia.............................................. As received NH3 30,000 64 3 50 12
Equilibrated NH3 30,000 32 4 50 12
Carbon monoxide...................................... As received CO 20,000 \4\ 64 2 (\3\) 60
Equilibrated CO 5,000 \2\ 32 3 (\3\) 60
.................... CO 3,000 \2\ 32 3 (\3\) 60
Combination of 2 or 3 of above types \5\
Combination of all above types \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 953pct; temperature of test atmosphere will be 252.5 deg. C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ Relative humidity of test atmosphere will be 953pct; temperature of test atmosphere entering the test fixture will be 02.5
deg.C-0 deg.C.
\5\ Test conditions and requirements will be applicable as shown in this table.
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and
ammonia will be 6 min instead of 12 min.
Table 6--Canister Bench Tests and Requirements for Chin-Style Gas Mask Canisters
[42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
---------------------------------------- Maximum
Flow rate Number of allowable Minimum
Canister type Test condition Concentration (liters tests penetration service life
Gas or vapor (parts per per (parts per (minutes)
million) minute) million) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................................ As received SO2 50,000 64 3 5 12
Equilibrated
.................... Cl2 5,000 64 3 5 12
.................... SO2 5,000 32 4 5 12
.................... Cl2 5,000 32 4 5 12
Organic vapor....................................... As received CCl4 5,000 64 3 5 12
Equilibrated
.................... CCl4 5,000 32 4 5 12
Ammonia............................................. As received NH3 5,000 64 3 50 12
Equilibrated
As received NH3 5,000 32 4 50 12
Equilibrated
Carbon monoxide..................................... As received CO 20,000 \2\ 64 2 (\3\) 60
.................... CO 5,000 \4\ 32 3 (\3\) 60
[[Page 30374]]
.................... CO 3,000 \2\ 32 3 (\3\) 60
Combination of 2 or 3 of above types \5\
Combination of all above types \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere will be 25 2.5 deg. C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere entering the test fixture will be 0
2.5 deg. C-0 deg. C.
\5\ Test conditions and requirements will be applicable as shown in this table.
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and
ammonia will be 6 min instead of 12 min.
Table 7.--Canister Bench Tests and Requirements for Escape Gas Mask Canisters
[42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
---------------------------------------- Maximum
Flow rate Number of allowable Minimum
Canister type Test condition Concentration (liters tests penetration service life
Gas or vapor (parts per per (parts per (minutes)
million) minute) million) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................................ As received......... SO2 5,000 64 3 5 12
Equilibrated........ Cl2 5,000 64 3 5 12
SO2 5,000 32 4 5 12
Cl2 5,000 32 4 5 12
Organic vapor....................................... As received......... CCl4 5,000 64 3 5 12
Equilibrated........ CCl4 5,000 32 4 5 12
Ammonia............................................. As received......... NH3 5,000 64 3 50 12
Equilibrated........ NH3 5,000 32 4 50 12
Carbon monoxide..................................... As received......... CO 10,000 \2\ 32 2 (\3\) \4\ 60
CO 5,000 \5\ 32 3 (\3\) 60
CO 3,000 \2\ 32 3 (\3\) 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 953pct; temperature of test atmosphere will be 252.5 deg. C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ If effluent temperature exceeds 100 deg. C during this test, the escape gas mask shall be equipped with an effective heat exchanger.
\5\ Relative humidity of test atmosphere will be 953 pct; temperature of test atmosphere entering the test fixture will be 02.5
deg. C--0 deg. C.
Subpart J--Supplied-Air Respirators
Sec. 84.130 Supplied-air respirators; description.
Supplied-air respirators, including all completely assembled
respirators designed for use as respiratory protection during entry
into and escape from atmospheres not immediately dangerous to life or
health are described as follows:
(a) Type ``A'' supplied-air respirators. A hose mask respirator,
for entry into and escape from atmospheres not immediately dangerous to
life or health, which consists of a motor-driven or hand-operated
blower that permits the free entrance of air when the blower is not
operating, a strong large-diameter hose having a low resistance to
airflow, a harness to which the hose and the life-line are attached and
a tight-fitting facepiece.
(b) Type ``AE'' supplied-air respirators. A Type ``A'' supplied-air
respirator equipped with additional devices designed to protect the
wearer's head and neck against impact and abrasion from rebounding
abrasive material, and with shielding material such as plastic, glass,
woven wire, sheet metal, or other suitable material to protect the
window(s) of facepieces, hoods, and helmets which do not unduly
interfere with the wearer's vision and permit easy access to the
external surface of such window(s) for cleaning.
(c) Type ``B'' supplied-air respirators. A hose mask respirator,
for entry into and escape from atmospheres not immediately dangerous to
life or health, which consists of a strong large-diameter hose with low
resistance to airflow through which the user draws inspired air by
means of his lungs alone, a harness to which the hose is attached, and
a tight-fitting facepiece.
(d) Type ``BE'' supplied-air respirators. A type ``B'' supplied-air
respirator equipped with additional devices designed to protect the
wearer's head and neck against impact and abrasion from rebounding
abrasive material, and with shielding material such as plastic, glass,
woven wire, sheet metal, or other suitable material to protect the
window(s) of facepieces, hoods, and helmets which do not unduly
interfere with the wearer's vision and permit easy access to the
external surface of such window(s) for cleaning.
(e) Type ``C'' supplied-air respirators. An airline respirator, for
entry into and escape from atmospheres not immediately dangerous to
life or health, which consists of a source of respirable breathing air,
a hose, a detachable coupling, a control valve, orifice, a
[[Page 30375]] demand valve or pressure demand valve, an arrangement
for attaching the hose to the wearer, and a facepiece, hood, or helmet.
(f) Type ``CE'' supplied-air respirators. A type ``C'' supplied-air
respirator equipped with additional devices designed to protect the
wearer's head and neck against impact and abrasion from rebounding
abrasive material, and with shielding material such as plastic, glass,
woven wire, sheet metal, or other suitable material to protect the
window(s) of facepieces, hoods, and helmets which do not unduly
interfere with the wearer's vision and permit easy access to the
external surface of such window(s) for cleaning.
Sec. 84.131 Supplied-air respirators; required components.
(a) Each supplied-air respirator described in Sec. 84.130 shall,
where its design requires, contain the following component parts:
(1) Facepiece, hood, or helmet;
(2) Air supply valve, orifice, or demand or pressure-demand
regulator;
(3) Hand operated or motor driven air blower;
(4) Air supply hose;
(5) Detachable couplings;
(6) Flexible breathing tube; and
(7) Respirator harness.
(b) The component parts of each supplied-air respirator shall meet
the minimum construction requirements set forth in subpart G of this
part.
Sec. 84.132 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with supplied-air
respirators shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or
helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm
pressure.
Sec. 84.133 Harnesses; installation and construction; minimum
requirements.
(a) Each supplied-air respirator shall, where necessary, be
equipped with a suitable harness designed and constructed to hold the
components of the respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of respirator parts, and where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.134 Respirator containers; minimum requirements.
Supplied-air respirators shall be equipped with a substantial,
durable container bearing markings which show the applicant's name, the
type and commercial designation of the respirator it contains, and all
appropriate approval labels.
Sec. 84.135 Half-mask facepieces, full facepieces, hoods, and helmets;
fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit
persons with various head sizes, provide for the optional use of
corrective spectacles or lenses, and insure against any restriction of
movement by the wearer.
(d) Facepieces, hoods, and helmets shall be designed to prevent
eyepiece fogging.
Sec. 84.136 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
(a) Facepieces, hoods, and helmets shall be designed and
constructed to provide adequate vision which is not distorted by the
eyepiece.
(b) All eyepieces except those on Types B, BE, C, and CE supplied-
air respirators shall be designed and constructed to be impact and
penetration resistant. Federal Specification, Mask, Air Line: and
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965
with interim amendment-1, July 30, 1969, is an example of an
appropriate standard for determining impact and penetration resistance.
Copies of GGG-M-125d may be obtained from the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
(c)(1) The eyepieces of AE, BE, and CE type supplied-air
respirators shall be shielded by plastic, glass, woven wire, sheet
metal, or other suitable material which does not interfere with the
vision of the wearer.
(2) Shields shall be mounted and attached to the facepiece to
provide easy access to the external surface of the eyepiece for
cleaning.
Sec. 84.137 Inhalation and exhalation valves; check valves; minimum
requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against distortion.
(b) Exhalation valves shall be:
(1) Protected against damage and external influence; and
(2) Designed and constructed to prevent inward leakage of
contaminated air.
(c) Check valves designed and constructed to allow airflow toward
the facepiece only shall be provided in the connections to the
facepiece or in the hose fitting near the facepiece of all Type A, AE,
B, and BE supplied-air respirators.
Sec. 84.138 Head harnesses; minimum requirements.
Facepieces shall be equipped with adjustable and replaceable head
harnesses which are designed and constructed to provide adequate
tension during use, and an even distribution of pressure over the
entire area in contact with the face.
Sec. 84.139 Head and neck protection; supplied-air respirators;
minimum requirements.
Type AE, BE, and CE supplied-air respirators shall be designed and
constructed to provide protection against impact and abrasion from
rebounding abrasive materials to the wearer's head and neck.
Sec. 84.140 Air velocity and noise levels; hoods and helmets; minimum
requirements.
Noise levels generated by the respirator will be measured inside
the hood or helmet at maximum airflow obtainable within pressure and
hose length requirements and shall not exceed 80 dBA.
Sec. 84.141 Breathing gas; minimum requirements.
(a) Breathing gas used to supply supplied-air respirators shall be
respirable breathing air and contain no less than 19.5 volume-percent
of oxygen.
(b) Compressed, gaseous breathing air shall meet the applicable
minimum grade requirements for Type I gaseous air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade D or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
American National Standards Institute, Inc., 1430 Broadway, New York,
NY 10018. Copies may be [[Page 30376]] inspected at the NIOSH,
Certification and Quality Assurance Branch, 1095 Willowdale Road,
Morgantown, WV 26505-2888, or at the Office of the Federal Register,
800 North Capitol Street, NW., suite 700, Washington, DC.
(c) Compressed, liquefied breathing air shall meet the applicable
minimum grade requirements for Type II liquid air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade B or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
American National Standards Institute, Inc., 1430 Broadway, New York,
NY 10018. Copies may be inspected at the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888, or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
Sec. 84.142 Air supply source; hand-operated or motor driven air
blowers; Type A supplied-air respirators; minimum requirements.
(a) Blowers shall be designed and constructed to deliver an
adequate amount of air to the wearer with either direction of rotation,
unless constructed to permit rotation in one direction only, and to
permit the free entrance of air to the hose when the blower is not
operated.
(b) No multiple systems, whereby more than one user is supplied by
one blower, will be approved, unless each hose line is connected
directly to a manifold at the blower.
Sec. 84.143 Terminal fittings or chambers; Type B supplied-air
respirators; minimum requirements.
(a) Blowers or connections to air supplies providing positive
pressures shall not be approved for use on Type B supplied-air
respirators.
(b) Terminal fittings or chambers employed in Type B supplied-air
respirators, shall be:
(1) Installed in the inlet of the hose.
(2) Designed and constructed to provide for the drawing of air
through corrosion resistant material arranged so as to be capable of
removing material larger than 0.149 mm. in diameter (149 micrometers,
100-mesh, U.S. Standard sieve).
(3) Installed to provide a means for fastening or anchoring the
fitting or chamber in a fixed position in a zone of respirable air.
Sec. 84.144 Hand-operated blower test; minimum requirements.
(a) Hand-operated blowers shall be tested by attaching them to a
mechanical drive and operating them 6 to 8 hours daily for a period of
100 hours at a speed necessary to deliver 50 liters of air per minute
through each completely assembled respirator. Each respirator shall be
equipped with the maximum length of hose with which the device is to be
approved and the hose shall be connected to each blower or manifold
outlet designed for hose connections.
(b) The crank speed of the hand-operated blower shall not exceed 50
revolutions per minute in order to deliver the required 50 liters of
air per minute to each facepiece.
(c) The power required to deliver 50 liters of air per minute to
each wearer through the maximum length of hose shall not exceed one-
fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg.
(5 pounds) on a 20 cm. (8-inch) crank, as defined in Sec. 84.146.
(d) The blower shall operate throughout the period without failure
or indication of excessive wear of bearings or other working parts.
Sec. 84.145 Motor-operated blower test; minimum requirements.
(a) Motor-operated blowers shall be tested by operating them at
their specified running speed 6 to 8 hours daily for a period of 100
hours when assembled with the kind and maximum length of hose for which
the device is to be approved and when connected to each blower or
manifold outlet designed for hose connections.
(b) The connection between the motor and the blower shall be so
constructed that the motor may be disengaged from the blower when the
blower is operated by hand.
(c) The blower shall operate throughout the period without failure
or indication of excessive wear of bearings or other working parts.
(d) Where a blower, which is ordinarily motor driven, is operated
by hand, the power required to deliver 50 liters of air per minute to
each wearer through the maximum length of hose shall not exceed one-
fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg.
(5 pounds) on a 20 cm. (8-inch) crank, as defined in Sec. 84.146.
(e) Where the respirator is assembled with the facepiece and 15 m.
(50 feet) of the hose for which it is to be approved, and when
connected to one outlet with all other outlets closed and operated at a
speed not exceeding 50 revolutions of the crank per minute, the amount
of air delivered into the respiratory-inlet covering shall not exceed
150 liters per minute.
Sec. 84.146 Method of measuring the power and torque required to
operate blowers.
As shown in Figure 1 of this section, the blower crank is replaced
by a wooden drum, a (13 cm. (5 inches) in diameter is convenient). This
drum is wound with about 12 m. (40 feet) of No. 2 picture cord, b. A
weight, c, of sufficient mass to rotate the blower at the desired speed
is suspended from this wire cord. A mark is made on the cord about 3 to
4.5 m. (10 to 15 feet) from the weight, c. Another mark is placed at a
measured distance (6-9 m./20-30 feet is convenient) from the first.
These are used to facilitate timing. To determine the torque or
horsepower required to operate the blower, the drum is started in
rotation manually at or slightly above the speed at which the power
measurement is to be made. The blower is then permitted to assume
constant speed, and then as the first mark on the wire leaves the drum,
a stopwatch is started. The watch is stopped when the second mark
leaves the drum. From these data the foot-pounds per minute and the
torque may be calculated.
BILLING CODE 4160-19-P
[[Page 30377]]
Figure 1--Apparatus for measuring power required to operate blower.
(42 CFR part 84, subpart J, Sec. 84.146)
[GRAPHIC][TIFF OMITTED]TR08JN95.000
BILLING CODE 4160-19-C
Sec. 84.147 Type B supplied-air respirator; minimum requirements.
No Type B supplied-air respirator shall be approved for use with a
blower or with connection to an air supply device at positive
pressures.
Sec. 84.148 Type C supplied-air respirator, continuous flow class;
minimum requirements.
(a) Respirators tested under this section shall be approved only
when they supply respirable air at the pressures and quantities
required.
(b) The pressure at the inlet of the hose connection shall not
exceed 863 kN/m.\2\ (125 pounds per square inch gage).
(c) Where the pressure at any point in the supply system exceeds
863 kN/m.\2\ (125 pounds per square inch gage), the respirator shall be
equipped with a pressure-release mechanism that will prevent the
pressure at the hose connection from exceeding 863 kN/m.\2\ (125 pounds
per square inch gage) under any conditions.
Sec. 84.149 Type C supplied-air respirator, demand and pressure demand
class; minimum requirements.
(a) Respirators tested under this section shall be approved only
when used to supply respirable air at the pressures and quantities
required.
(b) The manufacturer shall specify the range of air pressure at the
point of attachment of the air-supply hose to the air-supply system,
and the range of hose length for the respirator. For example, he might
specify that the respirator be used with compressed air at pressures
ranging from 280-550 kN/m.\2\ (40 to 80 pounds per square inch) with
from 6 to 76 m. (15 to 250 feet) of air-supply hose.
(c) The specified air pressure at the point of attachment of the
hose to the air-supply system shall not exceed 863 kN/m.\2\ (125 pounds
per square inch gage).
(d)(1) Where the pressure in the air-supply system exceeds 863 kN/
m.\2\ (125 pounds per square inch gage), the respirator shall be
equipped with a pressure-release mechanism that will prevent the
pressure at the point of attachment of the hose to the air-supply
system from exceeding 863 kN/m.\2\ (125 pounds per square inch gage).
(2) The pressure-release mechanism shall be set to operate at a
pressure not more than 20 percent above the manufacturer's highest
specified pressure. For example, if the highest specified pressure is
863 kN/m.\2\ (125 pounds per square inch), the pressure-release
mechanism would be set to operate at a maximum of 1,035 kN/m.\2\ (150
pounds per square inch).
Sec. 84.150 Air-supply line tests; minimum requirements.
Air supply lines employed on Type A, Type B, and Type C supplied-
air respirators shall meet the minimum test requirements set forth in
Table 8 of this subpart.
Sec. 84.151 Harness test; minimum requirements.
(a)(1) Shoulder straps employed on Type A supplied-air respirators
shall be tested for strength of material, joints, and seams and must
separately withstand a pull of 113 kg. (250 pounds) for 30 minutes
without failure.
(2) Belts, rings, and attachments for life lines must withstand a
pull of 136 kg. (300 pounds) for 30 minutes without failure.
(3) The hose shall be firmly attached to the harness so as to
withstand a pull of 113 kg. (250 pounds) for 30 minutes without
separating, and the hose attachments shall be arranged so that the pull
or drag of the hose behind an advancing wearer does not disarrange the
harness or exert pull upon the facepiece.
(4) The arrangement and suitability of all harness accessories and
fittings will be considered.
(b)(1) The harness employed on Type B supplied-air respirators
shall not be uncomfortable, disturbing, or interfere with the movements
of the wearer.
(2) The harness shall be easily adjustable to various sizes.
(3) The hose shall be attached to the harness in a manner that will
withstand a pull of 45 kg. (100 pounds) for 30 minutes without
separating or showing signs of failure. [[Page 30378]]
(4) The design of the harness and attachment of the line shall
permit dragging the maximum length of hose considered for approval over
a concrete floor without disarranging the harness or exerting a pull on
the facepiece.
(5) The arrangement and suitability of all harness accessories and
fittings will be considered.
(c) The harness employed on Type C respirators shall be similar to
that required on the Type B respirator, or, it may consist of a simple
arrangement for attaching the hose to a part of the wearer's clothing
in a practical manner that prevents a pull equivalent to dragging the
maximum length of the hose over a concrete floor from exerting pull
upon the respiratory-inlet covering.
(d) Where supplied-air respirators have a rigid or partly rigid
head covering, a suitable harness shall be required to assist in
holding this covering in place.
Sec. 84.152 Breathing tube test; minimum requirements.
(a)(1) Type A and Type B supplied-air respirators shall employ one
or two flexible breathing tubes of the nonkinking type which extend
from the facepiece to a connecting hose coupling attached to the belt
or harness.
(2) The breathing tubes employed shall permit free head movement,
insure against closing off by kinking or by chin or arm pressure, and
they shall not create a pull that will loosen the facepiece or disturb
the wearer.
(b) Breathing tubes employed on Type C supplied-air respirators of
the continuous flow class shall meet the minimum requirements set forth
in paragraph (a) of this section, however, an extension of the
connecting hose may be employed in lieu of the breathing tubes
required.
(c)(1) A flexible, nonkinking type breathing tube shall:
(i) Be employed on Type C supplied-air respirators of the demand
and pressure-demand class; and
(ii) Extend from the facepiece to the demand or pressure-demand
valve, except where the valve is attached directly to the facepiece.
(2) The breathing tube shall permit free head movement, insure
against closing off by kinking or by chin or arm pressure, and shall
not create a pull that will loosen the facepiece or disturb the wearer.
Sec. 84.153 Airflow resistance test, Type A and Type AE supplied-air
respirators; minimum requirements.
(a) Airflow resistance will be determined when the respirator is
completely assembled with the respiratory-inlet covering, the air-
supply device, and the maximum length of air-supply hose coiled for
one-half its length in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.
(b) The inhalation resistance, drawn at the rate of 85 liters (3
cubic feet) per minute when the blower is not operating or under any
practical condition of blower operation shall not exceed the following
amounts:
------------------------------------------------------------------------
Maximum length of hose for which Maximum resistance, water column
respirator is approved height
------------------------------------------------------------------------
Feet Meters Inches Millimeters
------------------------------------------------------------------------
75............ 23 1.5 38
150........... 46 2.5 64
250........... 76 3.5 89
300........... 91 4.0 102
------------------------------------------------------------------------
(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of
water-column height at a flow rate of 85 liters (3 cubic feet) per
minute when the blower is not operating or under any practical
condition of blower operation.
Sec. 84.154 Airflow resistance test; Type B and Type BE supplied-air
respirators; minimum requirements.
(a) Airflow resistance shall be determined when the respirator is
completely assembled with the respiratory-inlet covering and the hose
in the maximum length to be considered for approval, coiled in loops
1.5 to 2.1 m. (5 to 7 feet) in diameter.
(b) Airflow resistance shall not exceed 38 mm. (1.5 inches) of
water-column height to air drawn at the flow rate of 85 liters (3 cubic
feet) per minute.
(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of
water-column height at this flow rate.
Sec. 84.155 Airflow resistance test; Type C supplied-air respirator,
continuous flow class and Type CE supplied-air respirator; minimum
requirements.
The resistance to air flowing from the respirator shall not exceed
25 mm. (1 inch) of water-column height when the air flow into the
respiratory-inlet covering is 115 liters (4 cubic feet) per minute.
Sec. 84.156 Airflow resistance test; Type C supplied-air respirator,
demand class; minimum requirements.
(a) Inhalation resistance shall not exceed 50 millimeters (2
inches) of water at an air flow of 115 liters (4 cubic feet) per
minute.
(b) The exhalation resistance to a flow of air at a rate of 85
liters (3 cubic feet) per minute shall not exceed 25 millimeters (1
inch) of water.
Sec. 84.157 Airflow resistance test; Type C supplied-air respirator,
pressure-demand class; minimum requirements.
(a) The static pressure in the facepiece shall not exceed 38 mm.
(1.5 inches) of water-column height.
(b) The pressure in the facepiece shall not fall below atmospheric
at inhalation airflows less than 115 liters (4 cubic feet) per minute.
(c) The exhalation resistance to a flow of air at a rate of 85
liters (3 cubic feet) per minute shall not exceed the static pressure
in the facepiece by more than 51 mm. (2 inches) of water-column height.
Sec. 84.158 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Sec. 84.159 Man tests for gases and vapors; supplied-air respirators;
general performance requirements.
(a) Wearers will enter a chamber containing a gas or vapor as
prescribed in Secs. 84.160, 84.161, 84.162, and 84.163.
(b) Each wearer will spend 10 minutes in work to provide
observations on freedom of the device from leakage. The freedom and
comfort allowed the wearer will also be considered.
(c) Time during the test period will be divided as follows:
(1) Five minutes. Walking, turning head, dipping chin; and
(2) Five minutes. Pumping air with a tire pump into a 28-liter (1
cubic foot) container, or equivalent work. [[Page 30379]]
(d) No odor of the test gas or vapor shall be detected by the
wearer in the air breathed during any such test, and the wearer shall
not be subjected to any undue discomfort or encumbrance because of the
fit, air delivery, or other features of the respirator during the
testing period.
Sec. 84.160 Man test for gases and vapors; Type A and Type AE
respirators; test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.10.025 percent isoamyl acetate vapor, and the
blower, the intake of the hose, and not more than 25 percent of the
hose length will be located in isoamyl acetate-free air.
(b) The man in the isoamyl acetate atmosphere will draw his
inspired air through the hose, connections, and all parts of the air
device by means of his lungs alone (blower not operating).
(c) The 10-minute work test will be repeated with the blower in
operation at any practical speed up to 50 revolutions of the crank per
minute.
Sec. 84.161 Man test for gases and vapors; Type B and Type BE
respirators; test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.10.025 percent isoamyl acetate vapor, and the
intake of the hose, and not more than 25 percent of the hose length
will be located in isoamyl acetate-free air.
(b) The man in the isoamyl acetate atmosphere will draw his
inspired air through the hose and connections by means of his lungs
alone.
Sec. 84.162 Man test for gases and vapors; Type C respirators,
continuous-flow class and Type CE supplied-air respirators; test
requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.10.025 percent isoamyl acetate vapor, the
intake of the hose will be connected to a suitable source of respirable
air, and not more than 25 percent of the hose length will be located in
isoamyl acetate-free air.
(b) The minimum flow of air required to maintain a positive
pressure in the respiratory-inlet covering throughout the entire
breathing cycle will be supplied to the wearer, provided however, that
airflow shall not be less than 115 liters per minute for tight-fitting
and not less than 170 liters per minute for loose-fitting respiratory
inlet-coverings.
(c) The test will be repeated with the maximum rate of flow
attainable within specified operating pressures.
Sec. 84.163 Man test for gases and vapors; Type C supplied-air
respirators, demand and pressure-demand classes; test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.10.025 percent isoamyl acetate vapor, the
intake of the hose will be connected to a suitable source of respirable
air, and not more than 25 percent of the hose length will be located in
isoamyl acetate-free air.
(b) The test will be conducted at the minimum pressure with the
maximum hose length and will be repeated at the maximum pressure with
the minimum hose length.
Tables to Subpart J of Part 84
Table 8--Air-Supply-Line Requirements and Tests
[42 CFR part 84, subpart J]
------------------------------------------------------------------------
Requirements for the air-supply lines of the indicated
Specific type of supplied-air respirators
requirements -------------------------------------------------------
Type A Type B Type C
------------------------------------------------------------------------
Length of hose.. Maximum of 91 Maximum of 23 Maximum of 91 m.
m. (300 feet), m. (75 feet) (300 feet) in
in multiples in multiples multiples of 7.6 m.
of 7.6 m. (25 of 7.6 m. (25 (25 feet). It will
feet). feet). be permissible for
the applicant to
supply hose of the
approved type of
shorter length than
7.6 m. (25 feet)
provided it meets
the requirements of
the part.
Air flow........ None........... None........... The air-supply hose
with air regulating
valve or orifice
shall permit a flow
of not less than
115 liters (4 cubic
feet) per minute to
tight-fitting and
170 liters (6 cubic
feet) per minute to
loose-fitting
respiratory-inlet
coverings through
the maximum length
of hose for which
approval is granted
and at the minimum
specified air-
supply pressure.
The maximum flow
shall not exceed
425 liters (15
cubic feet) per
minute at the
maximum specified
air-supply pressure
with the minimum
length of hose for
which approval is
granted.
[[Page 30380]]
Air flow........ ......do....... ......do....... The air-supply hose,
detachable
coupling, and
demand valve of the
demand class or
pressure-demand
valve of the
pressure-demand
class for Type C
supplied-air
respirators, demand
and pressure-demand
classes, shall be
capable of
delivering
respirable air at a
rate of not less
than 115 liters (4
cubic feet) per
minute to the
respiratory-inlet
covering at an
inhalation
resistance not
exceeding 50
millimeters (2
inches) of water-
column height
measured in the
respiratory-inlet
covering with any
combination of air-
supply pressure and
length of hose
within the
applicant's
specified range of
pressure and hose
length. The air-
flow rate and
resistance to
inhalation shall be
measured while the
demand or pressure-
demand valve is
actuated 20 times
per minute by a
source of
intermittent
suction. The
maximum rate of
flow to the
respiratory-inlet
covering shall not
exceed 425 liters
(15 cubic feet) per
minute under the
specified operating
conditions.
Air-regulating ......do....... ......do....... If an air-regulating
valve. valve is provided,
it shall be so
designed that it
will remain at a
specific
adjustment, which
will not be
affected by the
ordinary movement
of the wearer. The
valve must be so
constructed that
the air supply with
the maximum length
of hose and at the
minimum specified
air-supply pressure
will not be less
than 115 liters (4
cubic feet) of air
per minute to tight-
fitting and 170
liters (6 cubic
feet) of air per
minute of loose-
fitting respiratory
inlet coverings for
any adjustment of
the valve. If a
demand or pressure-
demand valve
replaces the air-
regulating valve,
it shall be
connected to the
air-supply at the
maximum air
pressure for which
approval is sought
by means of the
minimum length of
air-supply hose for
which approval is
sought. The outlet
of the demand or
pressure-demand
valve shall be
connected to a
source of
intermittent
suction so that the
demand or pressure-
demand valve is
actuated
approximately 20
times per minute
for a total of
100,000
inhalations. To
expedite this test,
the rate of
actuation may be
increased if
mutually agreeable
to the applicant
and NIOSH. During
this test the valve
shall function
without failure and
without excessive
wear of the moving
parts. The demand
or pressure-demand
valve shall not be
damaged in any way
when subjected at
the outlet to a
pressure or suction
of 25 cm. (10
inches) of water
gage for 2 minutes.
Noncollapsibilit The hose shall Same as Type A. None.
y. not collapse
or exhibit
permanent
deformation
when a force
of 90 kg. (200
pounds) is
applied for 5
minutes
between 2
planes 7.6 cm.
(3 inches)
wide on
opposite sides
of the hose.
[[Page 30381]]
Nonkinkability.. None........... None........... A 7.6 m. (25 foot)
section of the hose
will be placed on a
horizontal-plane
surface and shaped
into a one-loop
coil with one end
of the hose
connected to an
airflow meter and
the other end of
the hose supplied
with air at the
minimum specified
supply pressure.
The connection
shall be in the
plane of the loop.
The other end of
the hose will be
pulled tangentially
to the loop and in
the plane of the
loop until the hose
straightens. To
meet the
requirements of
this test the loop
shall maintain a
uniform near-
circular shape and
ultimately unfold
as a spiral,
without any
localized
deformation that
decreases the flow
of air to less than
90 percent of the
flow when the hose
is tested while
remaining in a
straight line.
Strength of hose Hose and Same as Type A. Hose and couplings
and couplings. couplings shall not exhibit
shall not any separation or
separate or failure when tested
fail when with a pull of 45
tested with a kg. (100 pounds)
pull of 113 for 5 minutes and
kg. (250 when tested by
pounds) for 5 subjecting them to
minutes. an internal air
pressure of 2 times
the maximum
respirator-supply
pressure that is
specified by the
applicant or at 173
kN/m. 2 (25 pounds
per square inch)
gage, whichever is
higher.
Tightness....... No air leakage None........... Leakage of air
shall occur exceeding 50 cc.
when the hose per minute at each
and couplings coupling shall not
are joined and be permitted when
the joint(s) the hose and
are immersed couplings are
in water and joined and are
subjected to immersed in water,
an internal with air flowing
air pressure through the
of 35 kN/m. 2 respirator under a
(5 pounds per pressure of 173 kN/
square inch) m. 2 (25 pounds per
gage. square inch) gage
applied to the
inlet end of the
air-supply hose, or
at twice the
maximum respirator-
supply pressure
that is specified
by the applicant,
whichever is
higher.
Permeation of The permeation Same as for Same as for Type A,
hose by of the hose by Type A. except the test
gasoline. gasoline will period shall be 1
be tested by hour.
immersing 7.6
m. (25 feet)
of hose and
one coupling
in gasoline,
with air
flowing
through the
hose at the
rate of 8
liters per
minute for 6
hours. The air
from the hose
shall not
contain more
than 0.01
percent by
volume of
gasoline vapor
at the end of
the test.
Detachable None........... None........... A hand-operated
coupling. detachable coupling
by which the wearer
can readily attach
or detach the
connecting hose
shall be provided
at a convenient
location. This
coupling shall be
durable, remain
connected under all
conditions of
normal respirator
use, and meet the
prescribed tests
for strength and
tightness of hose
and couplings.
------------------------------------------------------------------------
Subpart K--Non-Powered Air-Purifying Particulate Respirators
Sec. 84.170 Non-powered air-purifying particulate respirators;
description.
(a) Non-powered air-purifying particulate respirators utilize the
wearer's negative inhalation pressure to draw the ambient air through
the air-purifying filter elements (filters) to remove particulates from
the ambient air. They are designed for use as respiratory protection
against atmospheres with particulate contaminants (e.g., dusts, fumes,
mists) that are not immediately dangerous to life or health and that
contain adequate oxygen to support life.
(b) Non-powered air-purifying particulate respirators are
classified into three series, N-, R-, and P-series. The N-series
filters are restricted to use in those workplaces free of oil aerosols.
The R- and P-series filters are intended for removal of any particulate
that includes oil-based liquid particulates.
(c) Non-powered air-purifying particulate respirators are
classified according to the efficiency level of the filter(s) as tested
according to the requirements of this part.
(1) N100, R100, and P100 filters shall demonstrate a minimum
efficiency level of 99.97 percent.
(2) N99, R99, and P99 filters shall demonstrate a minimum
efficiency level of 99 percent. [[Page 30382]]
(3) N95, R95, and P95 filters shall demonstrate a minimum
efficiency level of 95 percent.
Sec. 84.171 Non-powered air-purifying particulate respirators;
required components.
(a) Each non-powered air-purifying particulate respirator described
in Sec. 84.170 shall, where its design requires, contain the following
component parts:
(1) Facepiece, mouthpiece with noseclip, hood, or helmet;
(2) Filter unit;
(3) Harness;
(4) Attached blower; and
(5) Breathing tube.
(b) The components of each non-powered air-purifying particulate
respirator shall meet the minimum construction requirements set forth
in subpart G of this part.
Sec. 84.172 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with respirators shall
be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or
helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm
pressure.
Sec. 84.173 Harnesses; installation and construction; minimum
requirements.
(a) Each respirator shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of respirator parts, and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.174 Respirator containers; minimum requirements.
(a) Except as provided in paragraph (b) of this section each
respirator shall be equipped with a substantial, durable container
bearing markings which show the applicant's name, the type of
respirator it contains, and all appropriate approval labels.
(b) Containers for single-use respirators may provide for storage
of more than one respirator, however, such containers shall be designed
and constructed to prevent contamination of respirators which are not
removed, and to prevent damage to respirators during transit.
Sec. 84.175 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit
persons with various head sizes, provide for the optional use of
corrective spectacles or lenses, and insure against any restriction of
movement by the wearer.
(d) Mouthpieces shall be equipped with noseclips which are securely
attached to the mouthpiece or respirator and provide an airtight seal.
(e) Facepieces, hoods, and helmets shall be designed to prevent
eyepiece fogging.
(f) Half-mask facepieces shall not interfere with the fit of common
industrial safety corrective spectacles.
Sec. 84.176 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
Facepieces, hoods, and helmets shall be designed and constructed to
provide adequate vision which is not distorted by the eyepieces.
Sec. 84.177 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be protected against
distortion.
(b) Inhalation valves shall be designed and constructed and
provided where necessary to prevent excessive exhaled air from
adversely affecting filters, except where filters are specifically
designed to resist moisture.
(c) Exhalation valves shall be:
(1) Provided where necessary;
(2) Protected against damage and external influence; and
(3) Designed and constructed to prevent inward leakage of
contaminated air.
Sec. 84.178 Head harnesses; minimum requirements.
(a) All facepieces shall be equipped with head harnesses designed
and constructed to provide adequate tension during use and an even
distribution of pressure over the entire area in contact with the face.
(b) Facepiece head harnesses, except those employed on single-use
respirators, shall be adjustable and replaceable.
(c) Mouthpieces shall be equipped, where applicable, with
adjustable and replaceable harnesses, designed and constructed to hold
the mouthpiece in place.
Sec. 84.179 Non-powered air-purifying particulate respirators; filter
identification.
(a) The respirator manufacturer, as part of the application for
certification, shall specify the filter series and the filter
efficiency level (i.e., ``N95'', ``R95, ``P95'', ``N99, ``R99'',
``P99'', ``N100'', ``R100'', or ``P100'') for which certification is
being sought.
(b) Filters shall be prominently labeled as follows:
(1) N100 filters shall be labeled ``N100 Particulate Filter (99.97%
filter efficiency level)'' and shall be a color other than magenta.
(2) R100 filters shall be labeled ``R100 Particulate Filter (99.97%
filter efficiency level)'' and shall be a color other than magenta.
(3) P100 filters shall be labeled ``P100 Particulate Filter (99.97%
filter efficiency level)'' and shall be color coded magenta.
(4) N99 filters shall be labeled ``N99 Particulate Filter (99%
filter efficiency level)'' and shall be a color other than magenta.
(5) R99 filters shall be labeled ``R99 Particulate Filter (99%
filter efficiency level)'' and shall be a color other than magenta.
(6) P99 filters shall be labeled ``P99 Particulate Filter (99%
filter efficiency level)'' and shall be a color other than magenta.
(7) N95 filters shall be labeled as ``N95 Particulate Filter (95%
filter efficiency level)'' and shall be a color other than magenta.
(8) R95 filters shall be labeled as ``R95 Particulate Filter (95%
filter efficiency level)'' and shall be a color other than magenta.
(9) P95 filters shall be labeled as ``P95 Particulate Filter (95%
filter efficiency level)'' and shall be a color other than magenta.
Sec. 84.180 Airflow resistance tests.
(a) Resistance to airflow will be measured in the facepiece,
mouthpiece, hood, or helmet of a particulate respirator (complete
respirator) mounted on a test fixture with air flowing at continuous
rate of 852 liters per minute, before each test conducted
in accordance with Sec. 84.182.
(b) The resistances for particulate respirators upon initial
inhalation shall not exceed 35 mm water column height pressure and upon
initial exhalation shall not exceed 25 mm water column height
pressure. [[Page 30383]]
Sec. 84.181 Non-powered air-purifying particulate filter efficiency
level determination.
(a) Twenty filters of each non-powered air-purifying particulate
respirator model shall be tested for filter efficiency against:
(1) A solid sodium chloride particulate aerosol as per this
section, if N-series certification is requested by the applicant.
(2) A dioctyl phthalate or equivalent liquid particulate aerosol as
per this section, if R-series or P-series certification is requested by
the applicant.
(b) Filters including holders and gaskets; when separable, shall be
tested for filter efficiency level, as mounted on a test fixture in the
manner as used on the respirator.
(c) Prior to filter efficiency testing of 20 N-series filters, the
20 to be tested shall be taken out of their packaging and placed in an
environment of 855 percent relative humidity at
382.5 deg.C for 251 hours. Following the pre-
conditioning, filters shall be sealed in a gas-tight container and
tested within 10 hours.
(d) When the filters do not have separable holders and gaskets, the
exhalation valves shall be blocked so as to ensure that leakage, if
present, is not included in the filter efficiency level evaluation.
(e) For non-powered air-purifying particulate respirators with a
single filter, filters shall be tested at a continuous airflow rate of
854 liters per minute. Where filters are to be used in
pairs, the test-aerosol airflow rate shall be 42.52 liters
per minute through each filter.
(f) Filter efficiency test aerosols.
(1) When testing N-series filters, a sodium chloride or equivalent
solid aerosol at 255 deg.C and relative humidity of
3010 percent that has been neutralized to the Boltzmann
equilibrium state shall be used. Each filter shall be challenged with a
concentration not exceeding 200 mg/m\3\.
(2) When testing R-series and P-series filters, a neat cold-
nebulized dioctyl phthalate (DOP) or equivalent aerosol at
255 deg.C that has been neutralized to the Boltzmann
equilibrium state shall be used. Each filter shall be challenged with a
concentration not exceeding 200 mg/m\3\.
(3) The test shall continue until minimum efficiency is achieved or
until an aerosol mass of at least 2005 mg has contacted the
filter. For P-series filters, if the filter efficiency is decreasing
when the 2005 mg challenge point is reached, the test shall
be continued until there is no further decrease in efficiency.
(g) The sodium chloride test aerosol shall have a particle size
distribution with count median diameter of 0.0750.020
micrometer and a standard geometric deviation not exceeding 1.86 at the
specified test conditions as determined with a scanning mobility
particle sizer or equivalent. The DOP aerosol shall have a particle
size distribution with count median diameter of 0.1850.020
micrometer and a standard geometric deviation not exceeding 1.60 at the
specified test conditions as determined with a scanning mobility
particle sizer or equivalent.
(h) The efficiency of the filter shall be monitored and recorded
throughout the test period by a suitable forward-light-scattering
photometer or equivalent instrumentation.
(i) The minimum efficiency for each of the 20 filters shall be
determined and recorded and be equal to or greater than the filter
efficiency criterion listed for each level as follows:
P100, R100 and N100: Efficiency 99.97%
P99, R99 and N99: Efficiency 99%
P95, R95 and N95: Efficiency 95%
Sec. 84.182 Exhalation valve leakage test; minimum requirements.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Subpart L--Chemical Cartridge Respirators
Sec. 84.190 Chemical cartridge respirators: description.
(a) Chemical cartridge respirators including all completely
assembled respirators which are designed for use as respiratory
protection during entry into or escape from atmospheres not immediately
dangerous to life and health, are described according to the specific
gases or vapors against which they are designed to provide respiratory
protection, as follows:
------------------------------------------------------------------------
Maximum use
concentration,
Type of chemical cartridge respirator \1\ parts per
million
------------------------------------------------------------------------
Ammonia................................................. 300
Chlorine................................................ 10
Hydrogen chloride....................................... 50
Methyl amine............................................ 100
Organic vapor........................................... \2\ 1,000
Sulfur dioxide.......................................... 50
Vinyl chloride.......................................... 10
------------------------------------------------------------------------
\1\ Not for use against gases or vapors with poor warning properties
(except where MSHA or Occupational Safety and Health Administration
standards may permit such use for a specific gas or vapor) or those
which generate high heats of reaction with sorbent material in the
cartridge.
\2\ Maximum use concentrations are lower for organic vapors which
produce atmospheres immediately hazardous to life or health at
concentrations equal to or lower than this concentration.
(b) Chemical cartridge respirators for respiratory protection
against gases or vapors, which are not specifically listed with their
maximum use concentration, may be approved if the applicant submits a
request for such approval, in writing, to the Institute. The Institute
shall consider each such application and accept or reject the
application after a review of the effects on the wearer's health and
safety and in the light of any field experience in use of chemical
cartridge respirators as protection against such hazards.
Sec. 84.191 Chemical cartridge respirators; required components.
(a) Each chemical cartridge respirator described in Sec. 84.190
shall, where its design requires, contain the following component
parts:
(1) Facepiece, mouthpiece, and noseclip, hood, or helmet;
(2) Cartridge;
(3) Cartridge with filter;
(4) Harness;
(5) Breathing tube; and
(6) Attached blower.
(b) The components of each chemical cartridge respirator shall meet
the minimum construction requirements set forth in subpart G of this
part.
Sec. 84.192 Cartridges in parallel; resistance requirements.
Where two or more cartridges are used in parallel, their resistance
to airflow shall be essentially equal.
Sec. 84.193 Cartridges; color and markings; requirements.
The color and markings of all cartridges or labels shall conform
with the requirements of the American National Standards Institute,
American National Standard for Identification of Air-Purifying
Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is
incorporated by reference and has been approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from American [[Page 30384]] National Standards
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch,
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
Sec. 84.194 Filters used with chemical cartridges; location;
replacement.
(a) Particulate matter filters used in conjunction with a chemical
cartridge shall be located on the inlet side of the cartridge.
(b) Filters shall be incorporated in or firmly attached to the
cartridge and each filter assembly shall, where applicable, be designed
to permit its easy removal from and replacement on the cartridge.
Sec. 84.195 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with respirators shall
be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or
helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm
pressure.
Sec. 84.196 Harnesses; installation and construction; minimum
requirements.
(a) Each respirator shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of respirator parts and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.197 Respirator containers; minimum requirements.
Respirators shall be equipped with a substantial, durable container
bearing markings which show the applicant's name, the type and
commercial designation of the respirator it contains and all
appropriate approval labels.
Sec. 84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods,
and helmets; fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Hoods and helmets shall be designed and constructed to fit
persons with various head sizes, provide for the optional use of
corrective spectacles or lenses, and insure against any restriction of
movement by the wearer.
(c) Mouthpieces shall be equipped with noseclips which are securely
attached to the mouthpiece or respirator and provide an airtight fit.
(d) Full facepieces shall provide for optional use of corrective
spectacles or lenses which shall not reduce the respiratory protective
qualities of the respirator.
(e) Facepieces, hoods, and helmets shall be designed to prevent
eyepiece fogging.
Sec. 84.199 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
Facepieces, hoods, and helmets shall be designed and constructed to
provide adequate vision which is not distorted by the eyepieces.
Sec. 84.200 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against distortion.
(b) Inhalation valves shall be designed and constructed to prevent
excessive exhaled air from entering cartridges or adversely affecting
canisters.
(c) Exhalation valves shall be--
(1) Protected against damage and external influence; and
(2) Designed and constructed to prevent inward leakage of
contaminated air.
Sec. 84.201 Head harnesses; minimum requirements.
(a) (1) Facepieces for chemical cartridge respirators other than
single-use vinyl chloride shall be equipped with adjustable and
replaceable head harnesses designed and constructed to provide adequate
tension during use and an even distribution of pressure over the entire
area in contact with the face.
(2) Facepieces for single-use vinyl chloride respirators shall be
equipped with adjustable head harnesses designed and constructed to
provide adequate tension during use and an even distribution of
pressure over the entire area in contact with the face.
(b) Mouthpieces shall be equipped where applicable, with an
adjustable and replaceable harness designed and constructed to hold the
mouthpiece in place.
Sec. 84.202 Air velocity and noise levels; hoods and helmets; minimum
requirements.
Noise levels generated by the respirator will be measured inside
the hood or helmet at maximum airflow obtainable and shall not exceed
80 dBA.
Sec. 84.203 Breathing resistance test; minimum requirements.
(a) Resistance to airflow will be measured in the facepiece,
mouthpiece, hood, or helmet of a chemical cartridge respirator mounted
on a test fixture with air flowing at a continuous rate of 85 liters
per minute, both before and after each test conducted in accordance
with Secs. 84.206 through 84.207.
(b) The maximum allowable resistance requirements for chemical
cartridge respirators are as follows:
Maximum Resistance
[Millimeter water column height]
------------------------------------------------------------------------
Inhalation
Type of chemical-cartridge -------------------------- Exhalation
respirator Initial Final\1\
------------------------------------------------------------------------
Other than single-use vinyl
chloride respirators:
For gases, vapors, or gases
and vapors.................. 40 45 20
For gases, vapors, or gases
and vapors, and particulates 50 70 20
Single-use respirator with
valves:
For vinyl chloride........... 20 25 20
For vinyl chloride and
particulates................ 30 45 2
Single-use respirator without
valves:
For vinyl chloride........... 15 20 (2)
For vinyl chloride and
particulates................ 25 40 (2)
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 of this
subpart.
[[Page 30385]]
\2\ Same as inhalation.
Sec. 84.204 Exhalation valve leakage test; minimum requirements.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Sec. 84.205 Facepiece test; minimum requirements.
(a) The complete chemical cartridge respirator will be fitted to
the faces of persons having varying facial shapes and sizes.
(b) Where the applicant specifies a facepiece size or sizes for the
respirator together with the approximate measurement of faces they are
designed to fit, the Institute will provide test subjects to suit such
facial measurements.
(c) Any chemical cartridge respirator part which must be removed to
perform the facepiece or mouthpiece fit test shall be replaceable
without special tools and without disturbing facepiece or mouthpiece
fit.
(d) The facepiece or mouthpiece fit test using the positive or
negative pressure recommended by the applicant and described in his
instructions will be used before each test.
(e) (1) Each wearer will enter a chamber containing 100 p.p.m.
isoamyl acetate vapor for half-mask facepieces, and 1,000 p.p.m. for
full facepieces, mouthpieces, hoods, and helmets.
(2) The facepiece or mouthpiece may be adjusted, if necessary, in
the test chamber before starting the test.
(3) Each wearer will remain in the chamber for 8 minutes while
performing the following activities:
(i) Two minutes, nodding and turning head;
(ii) Two minutes, calisthenic arm movements;
(iii) Two minutes, running in place; and
(iv) Two minutes, pumping with a tire pump into a 28-liter (1
cubic-foot) container.
(4) Each wearer shall not detect the odor of isoamyl-acetate vapor
during the test.
Sec. 84.206 Particulate tests; respirators with filters; minimum
requirements; general.
(a) Three respirators with cartridges containing, or having
attached to them, filters for protection against particulates will be
tested in accordance with the provisions of Sec. 84.207.
(b) In addition to the test requirements set forth in paragraph (a)
of this section, three such respirators will be tested, as appropriate,
in accordance with the provisions of Secs. 84.179 through 84.183;
however, the maximum allowable resistance of complete particulate, and
gas, vapor, or gas and vapor chemical cartridge respirators shall not
exceed the maximum allowable limits set forth in Sec. 84.203.
Sec. 84.207 Bench tests; gas and vapor tests; minimum requirements;
general.
(a) Bench tests will be made on an apparatus that allows the test
atmosphere at 505 percent relative humidity and room
temperature, approximately 25 deg.C, to enter the cartridges
continuously at predetermined concentrations and rates of flow, and
that has means for determining the test life of the cartridges.
(b) Where two cartridges are used in parallel on a chemical
cartridge respirator, the bench test will be performed with the
cartridges arranged in parallel, and the test requirements will apply
to the combination rather than to the individual cartridges.
(c) Three cartridges or pairs of cartridges will be removed from
containers and tested as received from the applicant.
(d) Two air purifying cartridges or pairs of cartridges will be
equilibrated at room temperature by passing 25 percent relative
humidity air through them at the flow rate of 25 liters per minute
(l.p.m.) for 6 hours.
(e) Two air purifying cartridges or pairs of cartridges will be
equilibrated by passing 85 percent relative humidity air through them
at the flow rate of 25 l.p.m.
(f) All cartridges will be resealed, kept in an upright position,
at room temperatures, and tested within 18 hours.
(g) Cartridges will be tested and shall meet the minimum
requirements set forth in Table 11 of this subpart.
Tables to Subpart L of Part 84
Tables 9 and 10 [Reserved]
Table 11-Cartridge Bench Tests and Requirements
[42 CFR part 84, subpart L]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
------------------------------------- Flowrate Number of Penetration Minimum
Cartridge Test condition Concentration (l.p.m.) tests \1\ (p.p.m.) life \2\
Gas or vapor (p.p.m.) (min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ammonia...................... As received.................. NH3 1000 64 3 50 50
Ammonia...................... Equilibrated................. NH3 1000 32 4 50 50
Chlorine..................... As received.................. Cl2 500 64 3 5 35
Chlorine..................... Equilibrated................. Cl2 500 32 4 5 35
Hydrogen chloride............ As received.................. HCl 500 64 3 5 50
Hydrogen chloride............ Equilibrated................. HCl 500 32 4 5 50
Methylamine.................. As received.................. CH3NH2 1000 64 3 10 25
Methylamine.................. Equilibrated................. CH3NH2 1000 32 4 10 25
Organic vapors............... As received.................. CCl4 1000 64 3 5 50
Organic vapors............... Equilibrated................. CCl4 1000 32 4 5 50
Sulfur dioxide............... As received.................. SO2 500 64 3 5 30
Sulfur dioxide............... Equilibrated................. SO2 500 32 4 5 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
[[Page 30386]]
\2\ Where a respirator is designed for respiratory protection against more than one type of gas or vapor, as for use in ammonia and in chlorine, the
minimum life shall be one-half that shown for each type of gas or vapor. Where a respirator is designed for respiratory protection against more than
one gas of a type, as for use in chlorine and sulfur dioxide, the stated minimal life shall apply.
Subpart M--[Reserved]
Subpart N--Special Use Respirators
Sec. 84.250 Vinyl chloride respirators; description.
Vinyl chloride respirators, including all completely assembled
respirators which are designed for use as respiratory protection during
entry into and escape from vinyl chloride atmospheres containing
adequate oxygen to support life, are described according to their
construction as follows:
(a) Front-mounted or back-mounted gas masks;
(b) Chin-style gas masks;
(c) Chemical-cartridge respirators;
(d) Powered air-purifying respirators; and
(e) Other devices, including combination respirators.
Sec. 84.251 Required components.
(a) Each vinyl chloride respirator described in Sec. 84.250 shall,
where its design requires, contain the following component parts:
(1) Facepiece;
(2) Canister with end-of-service-life indicator;
(3) Cartridge with end-of-service-life indicator;
(4) Harness;
(5) Attached blower; and
(6) Breathing tube.
(b) The components of each vinyl chloride respirator shall meet the
minimum construction requirements set forth in Subpart G of this part.
Sec. 84.252 Gas masks; requirements and tests.
(a) Except for the tests prescribed in Sec. 84.126, the minimum
requirements and performance tests for gas masks, prescribed in Subpart
I of this part, are applicable to vinyl chloride gas masks.
(b) The following bench tests are applicable to canisters designed
for use with gas masks for entry into and escape from vinyl chloride
atmospheres containing adequate oxygen to support life:
(1) Four canisters will be equilibrated at 255 deg.C
by passing 855 percent relative humidity air through them
at 64 liters per minute for six hours.
(2) The equilibrated canisters will be resealed, kept in an upright
position at room temperature, and tested according to paragraph (b)(3)
of this section within 18 hours.
(3) The canisters equilibrated and stored as described in
paragraphs (b) (1) and (2) of this section will be tested on an
apparatus that allows the test atmosphere at 855 percent
relative humidity and 255 deg.C to enter the canister
continuously at a concentration of 25 ppm vinyl chloride monomer at a
total flow rate of 64 liters per minute.
(4) The maximum allowable penetration after six hours of testing
according to paragraph (b)(3) of this section shall not exceed 1 ppm
vinyl chloride.
(c) Where canisters are submitted for testing and approval with a
service life of more than four hours, the period of time for testing
for vinyl chloride penetration will be performed at 150% of the service
life specified in the manufacturer's application. (Example: If a
manufacturer requests approval of a respirator for six hours use
against exposure to vinyl chloride, the maximum allowable penetration
after nine hours of testing shall not exceed 1 ppm vinyl chloride.)
Sec. 84.253 Chemical-cartridge respirators; requirements and tests.
(a) Except for the tests prescribed in Secs. 84.206 and 84.207, the
minimum requirements and performance tests for chemical-cartridge
respirators prescribed in Subpart L of this part are applicable to
replaceable-cartridge and single-use vinyl chloride chemical-cartridge
respirators.
(b) The following bench tests are applicable to cartridges designed
for use with chemical-cartridge respirators for entry into and escape
from vinyl chloride atmospheres containing adequate oxygen to support
life:
(1) Where two cartridges are used in parallel on a chemical-
cartridge respirator, the bench test requirements will apply to the
combination rather than the individual cartridges.
(2) Four cartridges or pairs of cartridges will be equilibrated at
255 deg.C by passing 855 percent relative
humidity air through them at 25 liters per minute for six hours.
(3) The equilibrated cartridges will be resealed, kept in an
upright position, at room temperature, and tested according to
paragraphs (b)(4) and (b)(5) of this section for other than single-use
respirators or according to paragraphs (b)(6) and (b)(7) of this
section for single-use respirators within 18 hours.
(4) The cartridges or pairs of cartridges for other than single-use
respirators, equilibrated and stored as described in paragraphs (b)(1),
(b)(2), and (b)(3) of this section, will be tested on an apparatus that
allows the test atmosphere at 855 percent relative humidity
and 255 deg.C, to enter the cartridges or pairs of
cartridges continuously at a concentration of 10 ppm vinyl chloride
monomer at a total flowrate of 64 liters per minute.
(5) The maximum allowable penetration after 90 minutes testing of
cartridges or pairs of cartridges for other than single-use
respirators, according to paragraph (b)(4) of this section shall not
exceed 1 ppm vinyl chloride.
(6) The single-use respirators, equilibrated and stored as
described in paragraphs (b)(2) and (b)(3) of this section, will be
tested on an apparatus that allows a test atmosphere at 855
percent relative humidity and 255 deg.C to be cycled
through the respirator by a breathing machine at a concentration of 10
ppm vinyl chloride monomer at the rate of 24 respirations per minute at
a minute volume of 400.6 liters. Air exhaled through the
respirator will be 352 deg.C with 943 percent
relative humidity.
(7) The maximum allowable penetration after 144 minutes testing of
respirators, according to paragraph (b)(6) of this section, shall not
exceed 1 ppm vinyl chloride.
Sec. 84.254 Powered air-purifying respirators; requirements and tests.
(a) Except for the tests prescribed in Sec. 84.207, the minimum
requirements and performance tests for powered air-purifying
respirators prescribed in subpart L of this part are applicable to
vinyl chloride powered air-purifying respirators.
(b) The following bench tests are applicable to cartridges designed
for use with powered air-purifying respirators for entry into and
escape from vinyl chloride atmospheres containing adequate oxygen to
support life:
(1) Four cartridges will be equilibrated at 25 deg.C
by passing 855 percent relative humidity air through them
at 115 liters per minute for tight-fitting facepieces and 170 liters
per minute for loose-fitting hoods and helmets, for six hours.
(2) The equilibrated cartridges will be resealed, kept in an
upright position at room temperature and tested according to paragraph
(b)(3) of this section within 18 hours.
(3) The cartridges equilibrated and stored as described in
paragraphs (b) (1) and (2) of this section will be tested on an
apparatus that allows the test atmosphere at 855 percent
relative [[Page 30387]] humidity and 255 deg.C to enter
the cartridge continuously at a concentration of 25 ppm vinyl chloride
monomer at a total flow rate of 115 liters per minute for tight-fitting
facepieces and 170 liters per minute for loose-fitting hoods and
helmets.
(4) The maximum allowable penetration after six hours of testing
according to paragraph (b)(3) of this section shall not exceed 1 ppm
vinyl chloride.
Sec. 84.255 Requirements for end-of-service-life indicator.
(a) Each canister or cartridge submitted for testing and approval
in accordance with Secs. 84.252, 84.253, and 84.254 shall be equipped
with a canister or cartridge end-of-service-life indicator which shows
a satisfactory indicator change or other obvious warning before 1 ppm
vinyl chloride penetration occurs. The indicator shall show such change
or afford such warning at 8010 percent of the total service
life to 1 ppm leakage, as determined by continuing each test described
in Secs. 84.252(b), 84.253(b), and 84.254(b) until a 1 ppm leakage of
vinyl chloride occurs.
(b) The applicant shall provide sufficient pretest data to verify
the performance of the end-of-service-life indicator required in
paragraph (a) of this section.
Sec. 84.256 Quality control requirements.
(a) In addition to the construction and performance requirements
specified in Secs. 84.251, 84.252, 84.253, 84.254, and 84.255, the
quality control requirements in paragraphs (b), (c), and (d) of this
section apply to approval of gas masks, chemical cartridge respirators,
and powered air-purifying respirators for entry into and escape from
vinyl chloride atmospheres containing adequate oxygen to support life.
(b) The respirators submitted for approval as described in
paragraph (a) of this section shall be accompanied by a complete
quality control plan meeting the requirements of subpart E of this
part.
(c) (1) The applicant shall specify in the plan that a sufficient
number of samples will be drawn from each bulk container of sorbent
material and that where activated carbon is used, the following
specific tests will be performed:
(i) Apparent density;
(ii) Iodine number;
(iii) Moisture content;
(iv) Carbon tetrachloride number; and
(v) Mesh size.
(2) The tests in paragraph (c)(1) of this section shall be
performed in a quantity necessary to assure continued satisfactory
conformance of the canisters and cartridges to the requirements of this
subpart.
(d) Final performance quality control tests on the complete
canisters and cartridges shall be accomplished using the bench tests
and procedures prescribed in Secs. 84.252, 84.253, 84.254, and 84.255.
Sec. 84.257 Labeling requirements.
(a) A warning shall be placed on the label of each gas mask,
chemical-cartridge respirator, and powered air-purifying respirator,
and on the label of each canister and cartridge, alerting the wearer to
the need for a fitting test in accordance with the manufacturer's
facepiece fitting instructions, providing service life information,
providing specific instructions for disposal, and advising that the
wearer may communicate to NIOSH any difficulties that may be
experienced in the design and performance of any gas mask, chemical-
cartridge respirator, or powered air-purifying respirator approved
under the requirements of this subpart. The service lives of
respirators meeting the test requirements of this subpart shall be
specified as follows:
Chemical-cartridge respirator
1 hour.
Gas mask
4 hours.
Powered air-purifying respirator
4 hours.
(b) Where the service life of a respirator is approved for more
than four hours, the service life for which the respirator has been
approved will be specified.
Sec. 84.258 Fees.
The following fees shall be charged for the examination,
inspection, and testing of complete assemblies and components of
respirators described in Secs. 84.250 and 84.251:
Complete gas mask
$1,100
Complete chemical-cartridge respirator
1,150
Complete powered air-purifying respirator
1,500
Canister or cartridge only
750
Subparts O through JJ [Reserved]
Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray; Powered
Air-Purifying High Efficiency Respirators and Combination Gas Masks
Sec. 84.1100 Scope and effective dates.
The purpose of this subpart KK is to establish procedures and
requirements for issuing extensions of approval of particulate
respirators certified prior to July 10, 1995 under the provisions of 30
CFR part 11 (See 30 CFR part 11 edition, as revised July 1, 1994.), new
approvals and extensions of approval of particulate respirators for
applications that are in NIOSH receipt on July 10, 1995, and approval
of powered air-purifying respirators.
(a) Air-purifying respirators with particulate filters approved
under the provisions of this subpart after July 10, 1995 will have a 30
CFR part 11 approval label.
(b) Only changes or modifications of non-powered air-purifying
respirators with particulate filters approved under the provisions of
subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this
section and deemed necessary by NIOSH to ensure the health and safety
of the wearer will be approved until July 10, 1998 and will have a 30
CFR part 11 approval label.
(c) Only changes or modifications of powered air-purifying
respirators with particulate filters approved under the provisions of
subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this
section and deemed necessary by NIOSH to ensure the health and safety
of the wearer will be approved under this subpart until July 10, 1998
and will have a 30 CFR part 11 label.
(d) Approval of powered air-purifying respirators will be issued
under this subpart. Particulate filters for powered air-purifying
respirators approved under the provisions of this subpart shall be only
high-efficiency (HEPA) as described in Sec. 84.1130(a)(4) and will
carry a 42 CFR part 84 approval label. In addition, changes or
modifications of powered HEPA air-purifying respirators approved under
the provisions of this subpart KK will be approved under this subpart
and will have a 42 CFR part 84 approval label.
Sec. 84.1101 Definitions.
As used in this subpart
(a) Air Contamination Level means the standards of contaminant
levels prescribed by the Secretary of Labor in accordance with the
provisions of the Occupational Safety and Health Act of 1970 (Pub. L.
91-596; 84 Stat. 1590).
(b) DOP means a homogenous liquid aerosol, having a particle
diameter of 0.3 micrometer, which is generated by vaporization and
condensation of dioctyl phthalate.
(c) Pesticide means:
(1) Any substance or mixture of substances (including solvents and
impurities) intended to prevent, destroy, repel, or mitigate any
insect, rodent, nematode, fungus, weed, or other form of plant or
animal life or virus; and
(2) Any substance or mixture of substances (including solvents and
impurities) intended for use as a plant regulator, defoliant, or
desiccant, as defined in the Federal Insecticide,
[[Page 30388]] Fungicide, and Rodenticide Act of 1947, as amended (7
U.S.C. 135-135k), excluding fumigants which are applied as gases or
vapors or in a solid or liquid form as pellets or poured liquids for
subsequent release as gases or vapors.
(d) Radionuclide means an atom identified by the constitution of
its nucleus (specified by the number of protons Z, number of neutrons
N, and energy, or, alternatively, by the atomic number Z, mass number
A=(N+Z), and atomic mass) which exists for a measurable time; decays or
disintegrates spontaneously, emits radiation, and results in the
formation of new nuclides.
(e) Smoke means the products of incomplete combustion of organic
substances in the form of solid and liquid particles and gaseous
products in air, usually of sufficient concentration to perceptibility
obscure vision.
Sec. 84.1102 Examination, inspection and testing of complete
respirator assemblies; fees.
The following fees shall be charged by the Institute for the
examination, inspection and testing of complete respirator assemblies
approved under this subpart:
(a) Gas masks with particulate filter, including pesticide gas
masks--
(1) Single hazard--$1,100.
(2) Type N--$4,100.
(b) Dust, fume and mist respirators--
(1) Single particulate hazard having an Air Contamination Level
more than 0.05 mg./m.\3\ or 2 million particles per cubic foot--$500.
(2) Combination particulate hazards having an Air Contamination
Level more than 0.05 mg./m.\3\ or 2 million particles per cubic foot--
$750.
(3) Particulate hazards having an Air Contamination Level less than
0.05 mg./m.\3\ or 2 million particles per cubic foot, radon daughters
--$1,250.
(4) All dusts, fumes and mists--$2,000.
(c) Paint spray respirators--$1,600.
(d) Pesticide respirators--$1,600.
(e) Chemical cartridge respirators with particulate filter--$1,150.
Sec. 84.1103 Approval labels and markings; approval of contents; use.
(a) Full-scale reproductions of approval labels and markings, and a
sketch or description of the method of application and position on the
harness, container, canister, cartridge, filter, or other component,
together with instructions for the use and maintenance of the
respirator shall be submitted to MSHA and the Institute for approval.
(b) Approval labels for non-powered and powered air-purifying dust,
fume, mist respirators approved prior to July 10, 1995 under the
provisions of subpart K of 30 CFR part 11 (See 30 CFR Part 11 edition,
revised as of July 1, 1994.) shall bear the emblem of the Mine Safety
and Health Administration and the seal of the Department of Health and
Human Services, the applicant's name and address, an approval number
assigned by the Institute, a statement that the respirator was tested
and approved under subpart K of 30 CFR part 11 and, where appropriate,
restrictions or limitations placed upon the use of the respirator by
the Institute. The approval number assigned by the Institute shall be
designated by the prefix TC and a serial number.
(c) Approval labels for powered air-purifying respirators approved
under the provisions of this subpart shall bear the emblem of the
National Institute for Occupational Safety and Health and the seal of
the Department of Health and Human Services, the applicant's name and
address, an approval number assigned by the Institute, a statement
stating the respirator was tested under the provisions of this subpart,
and, where appropriate, restrictions or limitations placed upon the use
of the respirator by the Institute. The approval number assigned by the
Institute shall be designated by the prefix TC and a serial number.
(c) The Institute shall, where necessary, notify the applicant when
additional labels, markings, or instructions will be required.
(d) Approval labels and markings shall only be used by the
applicant to whom they were issued.
(e) Legible reproductions or abbreviated forms of the label
approved by the Institute for use on each respirator shall be attached
to or printed at the following locations:
------------------------------------------------------------------------
Respirator type Label type Location
------------------------------------------------------------------------
Gas mask with a Entire............. Mask and container.
particulate filter,
including pesticide gas
mask.
Dust, fume, and mist Entire............. Respirator container and
respirators. filter container.
Abbreviated........ Filters.
Chemical-cartridge Entire............. Respirator container,
respirator with a cartridge container,
particulate filter, and filter containers
including paint spray (where applicable).
respirator.
Abbreviated........ Cartridges and filters
and filter containers.
Pesticide respirator..... Entire............. Respirator container,
and cartridge and
filter containers.
Abbreviated........ Cartridges and filters.
------------------------------------------------------------------------
(f) The use of any MSHA and Institute approval label obligates the
applicant to whom it is issued to maintain or cause to be maintained
the approved quality control sampling schedule and the acceptable
quality level for each characteristic tested, and to assure that it is
manufactured according to the drawings and specifications upon which
the certificate of approval is based.
(g) Each respirator, respirator component, and respirator container
shall, as required by the Institute to assure quality control and
proper use of the respirator, be labeled distinctly to show the name of
the applicant, and the name and letters or numbers by which the
respirator or respirator component is designated for trade purposes,
and the lot number, serial number, or approximate date of manufacture.
Sec. 84.1130 Respirators; description.
(a) Dust, fume, and mist respirators, including all completely
assembled respirators designed for use as respiratory protection during
entry into and escape from atmospheres which contain adequate oxygen to
support life and hazardous particulates, are described as follows:
(1) Air-purifying respirators, either with replaceable or reusable
filters, designed as respiratory protection against dusts:
(i) Having an air contamination level not less than 0.05 milligram
per cubic meter of air, including but not limited to coal, arsenic,
cadmium, chromium, lead, and manganese; or
(ii) Having an air contamination level not less than 2 million
particles per cubic foot of air, including but not limited to aluminum,
flour, iron ore, and free silica, resulting principally from the
disintegration of a solid, e.g., dust clouds produced in mining,
[[Page 30389]] quarrying, and tunneling, and in dusts produced during
industrial operations, such as grinding, crushing, and the general
processing of minerals and other materials.
(2) Air-purifying respirators, with replaceable filters, designed
as respiratory protection against fumes of various metals having an air
contamination level not less than 0.05 milligram per cubic meter,
including but not limited to aluminum, antimony, arsenic, cadmium,
chromium, copper, iron, lead, magnesium, manganese, mercury (except
mercury vapor), and zinc, which result from the sublimation or
condensation of their respective vapors, or from the chemical reaction
between their respective vapors and gases.
(3) Air-purifying respirators, with replaceable filters, designed
as respiratory protection against mists of materials having an air
contamination level not less than 0.05 milligram per cubic meter or 2
million particles per cubic foot, e.g., mists produced by spray coating
with vitreous enamels, chromic acid mist produced during chromium
plating, and other mists of materials whose liquid vehicle does not
produce harmful gases or vapors.
(4) Air-purifying respirators, with replaceable filters, designed
as respiratory protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter, including
but not limited to lithium hydride and beryllium, and against
radionuclides.
(5) Air-purifying respirators, with replaceable filters, designed
as respiratory protection against radon daughters, and radon daughters
attached to dusts, fumes, and mists.
(6) Air-purifying respirators, with replaceable filters, designed
as respiratory protection against asbestos-containing dusts and mists.
(7) Air-purifying respirators, with replaceable filters, designed
as protection against various combinations of particulate matter.
(8) Air-purifying dust respirators designed as respiratory
protection against pneumoconiosis- and fibrosis-producing dusts, or
dusts and mists, including but not limited to aluminum, asbestos, coal,
flour, iron ore, and free silica.
(b) Gas masks containing filters for protection against dusts,
fumes, mists, and smokes in combination with gases, vapors, or gases
and vapors. These respirators are not for use against gases or vapors
with poor warning properties (except where MSHA or Occupational Safety
and Health Administration standards may permit such use for a specific
gas or vapor) or those which generate high heats of reaction with
sorbent material in the canister.
(c) Pesticide respirators, including all completely assembled
respirators which are designed for use as respiratory protection during
entry into and escape from atmospheres which contain pesticide hazards,
are described according to their construction as follows:
(1) Front-mounted or back-mounted gas masks;
(2) Chin-style gas mask;
(3) Chemical cartridge;
(4) Air-purifying respirator with attached blower; and,
(5) Other devices, including combination respirators.
(d) Respirators with cartridges containing or having attached to
them, filters for protection against mists of paints, lacquers, and
enamels. These respirators are not for use against gases or vapors with
poor warning properties (except where MSHA or Occupational Safety and
Health Administration standards may permit such use for a specific gas
or vapor) or those which generate high heats of reaction with sorbent
material in the cartridge.
(e) Respirators with cartridges containing or having attached to
them filters for protection against dusts, fumes, and mists, except the
mists of paints, lacquers, and enamels. These respirators are not for
use against gases or vapors with poor warning properties (except where
MSHA or Occupational Safety and Health Administration standards may
permit such use for a specific gas or vapor) or those which generate
high heats of reaction with sorbent material in the cartridge.
Sec. 84.1131 Respirators; required components.
(a) Each respirator described in Sec. 84.1130 shall, where its
design requires, contain the following component parts:
(1) Facepiece, mouthpiece with noseclip, hood, or helmet;
(2) Filter unit, canister with filter, or cartridge with filter;
(3) Harness;
(4) Attached blower; and
(5) Breathing tube.
(b) The components of each respirator shall meet the minimum
construction requirements set forth in Subpart G of this part.
Sec. 84.1132 Breathing tubes; minimum requirements.
(a) Flexible breathing tubes used in conjunction with respirators
shall be designed and constructed to prevent:
(1) Restriction of free head movement;
(2) Disturbance of the fit of facepieces, mouthpieces, hoods, or
helmets;
(3) Interference with the wearer's activities; and
(4) Shutoff of airflow due to kinking, or from chin or arm
pressure.
Sec. 84.1133 Harnesses; installation and construction; minimum
requirements.
(a) Each respirator shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of respirator parts, and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.1134 Respirator containers; minimum requirements.
(a) Except as provided in paragraph (b) of this section each
respirator shall be equipped with a substantial, durable container
bearing markings which show the applicant's name, the type of
respirator it contains, and all appropriate approval labels. Except for
dust, fume, and mist respirators, the commercial designation of the
respirator it contains shall be shown.
(b) Containers for single-use respirators may provide for storage
of more than one respirator, however, such containers shall be designed
and constructed to prevent contamination of respirators which are not
removed, and to prevent damage to respirators during transit.
(c) Containers for gas masks combinations shall be designed and
constructed to permit easy removal of the mask.
Sec. 84.1135 Half-mask facepieces, full facepieces, hoods, helmets,
and mouthpieces; fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit
persons with various head sizes, provide for the optional use of
corrective spectacles or lenses, and insure against any restriction of
movement by the wearer. [[Page 30390]]
(d) Mouthpieces shall be equipped with noseclips which are securely
attached to the mouthpiece or respirator and provide an airtight seal.
(e) Facepieces, hoods, and helmets shall be designed to prevent
eyepiece fogging.
(f) Half-mask facepieces shall not interfere with the fit of common
industrial safety corrective spectacles, as determined by the
Institute's facepiece tests in Secs. 84.1141, 84.1142, and 84.1156(b).
Sec. 84.1136 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
(a) Facepieces, hoods, and helmets shall be designed and
constructed to provide adequate vision which is not distorted by the
eyepieces.
(b) All eyepieces of gas masks combinations shall be designed and
constructed to be impact and penetration resistant. Federal
Specification, Mask, Air Line: and Respirator, Air Filtering,
Industrial, GGG-M-125d, October 11, 1965, with interim amendment-1,
July 30, 1969, is an example of an appropriate standard for determining
impact and penetration resistance. Copies of GGG-M-125d may be obtained
from the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888.
Sec. 84.1137 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be protected against
distortion.
(b) Inhalation valves shall be designed and constructed and
provided where necessary to prevent excessive exhaled air from
adversely affecting filters, cartridges, and canisters, except where
filters of dust, fume, and mist respirators are specifically designed
to resist moisture as prescribed in Sec. 84.1145.
(c) Exhalation valves shall be:
(1) Provided where necessary;
(2) Protected against damage and external influence; and
(3) Designed and constructed to prevent inward leakage of
contaminated air.
Sec. 84.1138 Head harnesses; minimum requirements.
(a) All facepieces shall be equipped with head harnesses designed
and constructed to provide adequate tension during use and an even
distribution of pressure over the entire area in contact with the face.
(b) Facepiece head harnesses, except those employed on single-use
dust, fume, and mist respirators, shall be adjustable and replaceable.
(c) Mouthpieces shall be equipped, where applicable, with
adjustable and replaceable harnesses, designed and constructed to hold
the mouthpiece in place.
Sec. 84.1139 Air velocity and noise levels; hoods and helmets; minimum
requirements.
Noise levels generated by the respirator will be measured inside
the hood or helmet at maximum airflow obtainable and shall not exceed
80 dBA.
Sec. 84.1140 Dust, fume, and mist respirators; performance
requirements; general.
Dust, fume, and mist respirators and the individual components of
each such device shall, as appropriate, meet the requirements for
performance and protection specified in the tests described in
Secs. 84.1141 through 84.1152 and prescribed in Tables 12 and 13.
Sec. 84.1141 Isoamyl acetate tightness test; dust, fume, and mist
respirators designed for respiratory protection against fumes of
various metals having an air contamination level not less than 0.05
milligram per cubic meter; minimum requirements.
(a) The respirator will be modified in such a manner that all of
the air that normally would be inhaled through the inhalation port(s)
is drawn through an efficient activated charcoal-filled canister, or
cartridge(s), without interference with the face-contacting portion of
the facepiece.
(b) The modified respirator will be worn by persons for at least 2
minutes each in a test chamber containing 100 parts (by volume) of
isoamyl-acetate vapor per million parts of air.
(c) The odor of isoamyl-acetate shall not be detected by the
wearers of the modified respirator while in the test atmosphere.
Sec. 84.1142 Isoamyl acetate tightness test; respirators designed for
respiratory protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter, or
against radionuclides; minimum requirements.
(a) The applicant shall provide a charcoal-filled canister or
cartridge of a size and resistance similar to the filter unit with
connectors which can be attached to the facepiece in the same manner as
the filter unit.
(b)(1) The canister or cartridge will be used in place of the
filter unit, and persons will each wear a modified half-mask facepiece
for 5 minutes in a test chamber containing 100 parts (by volume) of
isoamyl-acetate vapor per million parts of air.
(2) The following work schedule will be performed by each wearer in
the test chamber:
(i) Two minutes walking, nodding, and shaking head in normal
movements; and
(ii) Three minutes exercising and running in place.
(3) The facepiece shall be capable of adjustment, according to the
applicant's instructions, to each wearer's face, and the odor of
isoamyl-acetate shall not be detectable by any wearer during the test.
(c) Where the respirator is equipped with a full facepiece, hood,
helmet, or mouthpiece, the canister or cartridge will be used in place
of the filter unit, and persons will each wear the modified
respiratory-inlet covering for 5 minutes in a test chamber containing
1,000 parts (by volume) of isoamyl-acetate vapor per million parts of
air, performing the work schedule specified in paragraph (b)(2) of this
section.
Sec. 84.1143 Dust, fume, and mist air-purifying filter tests;
performance requirements; general.
Dust, fume, and mist respirators will be tested in accordance with
the schedule set forth in Table 13 of this subpart to determine their
effectiveness as protection against the particulate hazards specified
in Table 13.
Sec. 84.1144 Silica dust test for dust, fume, and mist respirators;
single-use or reusable filters; minimum requirements.
(a) Three non-powered respirators with single-use filters will be
tested for periods of 90 minutes each at a continuous airflow rate of
32 liters per minute.
(b) The relative humidity in the test chamber will be 20-80
percent, and the room temperature approximately 25 deg. C.
(c) The test suspension in the chamber will not be less than 50 nor
more than 60 milligrams of flint (99+ percent free silica) per cubic
meter of air.
(d) The flint in suspension will be ground to pass 99+ percent
through a 270-mesh sieve.
(e) The particle-size distribution of the test suspension will have
a geometric mean of 0.4 to 0.6 micrometer, and the standard geometric
deviation will not exceed 2.
(f) The total amount of unretained test suspension in samples taken
during testing shall not exceed 1.5 milligrams for a non-powered air-
purifying respirator.
(g) Three non-powered respirators with reusable filters will be
tested and shall meet the requirements specified in paragraphs (a)
through (f) of this section; each filter shall be tested three times:
Once as received; once after cleaning; and once after recleaning. The
applicant's instructions shall be followed for each cleaning.
[[Page 30391]]
Sec. 84.1145 Silica dust test; non-powered single-use dust
respirators; minimum requirements.
(a) Three respirators will be tested.
(b) As described in Sec. 84.1144, airflow will be cycled through
the respirator by a breathing machine at the rate of 24 respirations
per minute with a minute volume of 40 liters; a breathing machine cam
with a work rate of 622 kg.-m.2/minute shall be used.
(c) Air exhaled through the respirator will be 35 deg.
2 deg. C. with 94 3 percent relative humidity.
#
(d) Air inhaled through the respirator will be sampled and analyzed
for respirator leakage.
(e) The total amount of unretained test suspension, after drying,
in samples taken during testing, shall not exceed 1.8 milligrams for
any single test.
Sec. 84.1146 Lead fume test for dust, fume, and mist respirators;
minimum requirements.
(a) Three non-powered respirators will be tested for a period of
312 minutes each at a continuous airflow rate of 32 liters per minute.
(b) The relative humidity in the test chamber will be 20-80
percent, and the room temperature approximately 25 deg. C.
(c) The test suspension in the test chamber will not be less than
15 nor more than 20 milligrams of freshly generated lead-oxide fume,
calculated as lead (Pb), per cubic meter of air.
(d) The fume will be generated by impinging an oxygen-gas flame on
molten lead.
(e) Samples of the test suspension will be taken during each test
period for analysis.
(f) The total amount of unretained test suspension in the samples
taken during testing, which is analyzed and calculated as lead (Pb),
shall not exceed 1.5 milligrams of lead for a non-powered air-purifying
respirator.
Sec. 84.1147 Silica mist test for dust, fume, and mist respirators;
minimum requirements.
(a) Three non-powered respirators will be tested for a period of
312 minutes each at a continuous airflow rate of 32 liters per minute.
(b) The room temperature in the test chamber will be approximately
25 deg.C.
(c) The test suspension in the test chamber will not be less than
20 nor more than 25 milligrams of silica mist, weighed as silica dust,
per cubic meter of air.
(d) Mist will be produced by spraying an aqueous suspension of
flint (99+ percent free silica), and the flint shall be ground to pass
99+ percent through a 270-mesh sieve.
(e) Samples of the test suspension will be taken during each test
period for analysis.
(f) The total amount of silica mist unretained in the samples taken
during testing, weighed as silica dust, shall not exceed 2.5 milligrams
for a non-powered air-purifying respirator.
Sec. 84.1148 Tests for respirators designed for respiratory protection
against more than one type of dispersoid; minimum requirements.
Respirators designed as respiratory protection against more than
one particulate hazard (dust, fume, or mist) shall comply with all the
requirements of this part, with respect to each of the specific hazards
involved.
Sec. 84.1149 Airflow resistance tests; all dust, fume, and mist
respirators; minimum requirements.
(a) Resistance to airflow will be measured in the facepiece,
mouthpiece, hood, or helmet of a dust, fume, or mist respirator mounted
on a test fixture with air flowing at a continuous rate of 85 liters
per minute, both before and after each test conducted in accordance
with Secs. 84.1144 through 84.1147.
(b) The maximum allowable resistance requirements for dust, fume,
and mist respirators are as follows:
Maximum Resistance
[mm. water-column height]
------------------------------------------------------------------------
Initial Final
Type of respirator inhalation inhalation Exhalation
------------------------------------------------------------------------
Pneumoconiosis- and fibrosis-
producing dusts, or dusts and
mists........................... 12 15 15
Dust, fume, and mist, with single-
use filter...................... 30 50 20
Dust, fume, and mist, with
reusable filter................. 20 40 20
Radon daughter................... 18 \1\ 25 15
Asbestos dust and mist........... 18 25 15
------------------------------------------------------------------------
\1\ Measured after silica dust test described in Sec. 84.1144.
Sec. 84.1150 Exhalation valve leakage test; minimum requirements.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Sec. 84.1151 DOP filter test; respirators designed as respiratory
protection against dusts, fumes, and mists having an air contamination
level less than 0.05 milligram per cubic meter and against
radionuclides; minimum requirements.
(a) All single air-purifying respirator filter units will be tested
in an atmosphere concentration of 100 micrograms of DOP per liter of
air at continuous flow rates of 32 and 85 liters per minute for a
period of 5 to 10 seconds.
(b) Where filters are to be used in pairs, the flow rates will be
16 and 42.5 liters per minute, respectively, through each filter.
(c) The filter will be mounted on a connector in the same manner as
used on the respirator, and the total leakage for the connector and
filter shall not exceed 0.03 percent of the ambient DOP concentration
at either flow rate.
Sec. 84.1152 Silica dust loading test; respirators designed as
protection against dusts, fumes, and mists having an air contamination
level less than 0.05 milligram per cubic meter and against
radionuclides; minimum requirements.
(a) Three non-powered respirators will be tested in accordance with
the provisions of Sec. 84.1144, or equivalent, and shall meet the
minimum requirements of Secs. 84.1144 and 84.1149.
(b) Three powered air-purifying respirators will be tested in
accordance with the provisions of Sec. 84.1144 except they will be
tested for a period of 4 hours each at a flowrate not less than 115
liters per minute to tight-fitting facepieces, and not less than 170
liters per minute to loose-fitting hoods and helmets. The total amount
of unretained test suspension in samples taken during testing shall not
exceed 14.4 milligrams for a powered air-purifying respirator with
tight-fitting facepiece, and 21.3 milligrams for a powered air-
purifying respirator with loose-fitting hood or helmet. They shall meet
the minimum requirements of Sec. 84.1149.
[[Page 30392]]
Sec. 84.1153 Dust, fume, mist, and smoke tests; canister bench tests;
gas masks canisters containing filters; minimum requirements.
(a) Gas mask canisters containing filters for protection against
dusts, fumes, mists, and smokes in combination with gases, vapors, or
gases and vapors, will be tested as prescribed in Sec. 84.1140 except
for the breathing resistance which will be in accordance with
Sec. 84.122.
(b) Gas mask canisters designed for protection against smokes will
be tested in an atmospheric concentration of 100 micrograms of dioctyl
phthalate per liter of air at continuous flow rates of 32 liters per
minute and 85 liters per minute for a period of 5 to 10 seconds, and
the DOP leakage through the canister shall not exceed 0.03 percent of
the test concentration.
(c) Gas mask canisters containing filters for protection against
dusts, fumes, mists, and smokes in combination with gases, vapors, or
gases and vapors, will be tested as prescribed in Sec. 84.126.
Sec. 84.1154 Canister and cartridge requirements.
(a) Where two or more canisters or cartridges are used in parallel,
their resistance to airflow shall be essentially equal.
(b) The color and markings of all canisters and cartridges or
labels shall conform with the requirements of the American National
Standards Institute, American National Standard for Identification of
Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973.
ANSI K13.1 is incorporated by reference and has been approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be obtained from American National Standards
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch,
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
Sec. 84.1155 Filters used with canisters and cartridges; location;
replacement.
(a) Particulate matter filters used in conjunction with a canister
or cartridge shall be located on the inlet side of the canister or
cartridge.
(b) Filters shall be incorporated into or firmly attached to the
canister or cartridge and each filter assembly shall, where applicable,
be designed to permit its easy removal from and replacement on the
canister or cartridge.
Sec. 84.1156 Pesticide respirators; performance requirements; general.
Pesticide respirators and the individual components of each such
device shall, as appropriate, meet the following minimum requirements
for performance and protection:
(a) Breathing resistance test. (1) Airflow resistance will be
measured in the facepiece, mouthpiece, hood, or helmet of a pesticide
respirator mounted on a test fixture with air flowing at a continuous
rate of 85 liters per minute, both before and after each test conducted
in accordance with paragraphs (c) and (f) of this section.
(2) The maximum allowable resistance requirements for pesticide
respirators are as follows:
Maximum Resistance
[mm. water-column height]
------------------------------------------------------------------------
Inhalation
Type of pesticide respirator -------------------------- Exhalation
Initial Final \1\
------------------------------------------------------------------------
Front- or back-mounted gas mask.. 70 85 20
Chin-style gas mask.............. 65 80 20
Powered air-purifying \2\........ \2\ 50 \2\ 70 20
Chemical Cartridge............... 50 70 20
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Table 14 of this
subpart.
\2\ Resistance of filter(s), cartridge(s), and breathing tube(s) only
with blower not operating.
(b) Facepiece test. (1) The complete pesticide respirator will be
fitted to the faces of persons having varying facial shapes and sizes.
(2) Where the applicant specifies a facepiece size or sizes for his
respirator together with the approximate measurements of faces they are
designed to fit, the Institute will provide test subjects to suit such
facial measurements.
(3) Any pesticide respirator part which must be removed to perform
the facepiece fit test shall be replaceable without special tools and
without disturbing facepiece fit.
(4) The facepiece or mouthpiece fit test using positive or negative
pressure recommended by the applicant and described in his instructions
will be used during each test.
(5)(i) Each wearer will enter a chamber containing 1,000 p.p.m.
isoamyl-acetate vapor for a respirator equipped with a full facepiece,
mouthpiece, hood, or helmet and 100 p.p.m. isoamyl-acetate vapor for a
respirator equipped with a half-mask facepiece.
(ii) The facepiece, mouthpiece, hood, or helmet may be adjusted, if
necessary, in the test chamber before starting the test.
(iii) Each wearer will remain in the chamber while performing the
following activities:
(A) Two minutes, nodding and turning head;
(B) Two minutes, calisthenic arm movements;
(C) Two minutes, running in place; and
(D) Two minutes, pumping with a tire pump into a 28-liter (1 cubic
foot) container.
(iv) Each wearer shall not detect the odor of isoamyl-acetate
during the test.
(c) Silica dust test. Three completely assembled pesticide
respirators will be tested with a mechanical-testing apparatus as
follows:
(1) Temperature in the test chamber will be approximately 25 deg.
C.
(2) Continuous airflow through the respirator will be 32 liters per
minute for front-mounted, back-mounted, and chin-style gas mask
pesticide respirators and chemical cartridge pesticide respirators, and
not less than 115 (4 cubic feet) liters per minute to tight-fitting
facepieces and 170 liters (6 cubic feet) per minute to loose-fitting
hoods and helmets of powered air-purifying respirators. [[Page 30393]]
(3) The test aerosol will contain 50-60 milligrams of 99+ percent
free silica per cubic meter of air.
(4) The particle size distribution of the test suspension will have
a geometric mean diameter of 0.4 to 0.6 micrometer, with a standard
geometric deviation less than 2.
(5) Front-mounted, back-mounted, and chin-style gas mask pesticide
respirators and chemical cartridge pesticide respirators will be tested
for 90 minutes and powered air-purifying respirators will be tested for
4 hours.
(d) Lead fume test. Three completely assembled pesticide
respirators will be tested with a mechanical-testing apparatus as
follows:
(1) Continuous airflow through the respirator will be 32 liters per
minute for front-mounted, back-mounted, and chin-style gas mask
pesticide respirators and chemical cartridge pesticide respirators and
not less than 115 liters (4 cubic feet) per minute, for powered air-
purifying respirators with tight-fitting facepieces, and not less than
170 liters (6 cubic feet) per minute for powered air-purifying
respirators with loose-fitting hoods and helmets.
(2) The test aerosol will contain 15-20 milligrams of freshly
generated lead-oxide fume, calculated as lead, per cubic meter of air.
(3) The fume will be generated by impinging an oxygen-gas flame on
molten lead.
(4) Front-mounted, back-mounted, and chin-style gas mask pesticide
respirators and chemical cartridge pesticide respirators will be tested
for 90 minutes and powered air-purifying pesticide respirators will be
tested for 4 hours.
(5) The total amount of unretained test suspension, which is
analyzed and calculated as lead, shall not exceed:
(i) 0.43 milligram for any 90-minute test;
(ii) 4.8 milligrams for any 4-hour test made at 115 liters (4 cubic
feet) per minute; or
(iii) 6.2 milligrams for any 4-hour test made at 170 liters (6
cubic feet) per minute.
(e) Dioctyl-phthalate test. (1) All canisters submitted for use
with front-mounted and back-mounted gas mask pesticide respirators will
be tested in an atmospheric concentration of 100 micrograms of dioctyl-
phthalate per liter of air at continuous flow rates of 32 and 85 liters
per minute for a test period of 5 to 10 seconds.
(2) The DOP leakage through the canister shall not exceed 0.03
percent of the ambient DOP concentration.
(f) Bench tests for pesticide respirators. (1)(i) Bench tests will
be made on an apparatus that allows the test atmosphere at
505 percent relative humidity and at room temperature
(25 deg.2.5 deg. C.) to enter the canister or cartridge at
predetermined concentrations and rates of flow, and that has a means
for determining the test life of the canister or cartridge against
carbon tetrachloride.
(ii) Canisters and cartridges will be tested as they are used on
each pesticide respirator, either singly or in pairs.
(iii) Three canisters or cartridges or pairs of cartridges will be
removed from containers and tested as received from the applicant.
(iv) Two canisters, cartridges, or pairs of cartridges will be
equilibrated at room temperature by passing 25 percent relative
humidity air through them at the following flow rates (expressed as
liters per minute (l.p.m.)) for 6 hours:
------------------------------------------------------------------------
Airflow
Type of canister or cartridge rate,l.p.m.
------------------------------------------------------------------------
Air-purifying canister..................................... 64
Air-purifying cartridge.................................... 25
Powered air-purifying with tight-fitting facepiece......... 115
Powered air-purifying with loose-fitting hood or helmet.... 170
------------------------------------------------------------------------
(v) Two canisters, cartridges, or pairs of cartridges will be
equilibrated at room temperature by passing 85 percent relative
humidity air through them at the flow rates stated in paragraph
(f)(1)(iv) of this section for 6 hours.
(vi) The equilibrated canisters or cartridges will be resealed,
kept in an upright position at room temperature, and tested within 18
hours.
(2) Canisters and cartridges tested in accordance with the
provisions of this section shall meet the requirements specified in
Table 14 of this subpart.
Sec. 84.1157 Chemical cartridge respirators with particulate filters;
performance requirements; general.
Chemical cartridge respirators with particulate filters and the
individual components of each such device shall, as appropriate, meet
the following minimum requirements for performance and protection:
(a) Breathing resistance test. (1) Resistance to airflow will be
measured in the facepiece, mouthpiece, hood, or helmet of a chemical
cartridge respirator mounted on a test fixture with air flowing at a
continuous rate of 85 liters per minute, both before and after each
test conducted in accordance with paragraphs (d) through (f) of this
section.
(2) The maximum allowable resistance requirements for chemical
cartridge respirators are as follows:
Maximum Resistance
[mm. water-column height]
------------------------------------------------------------------------
Inhalation
Type of chemical cartridge -------------------------- Exhalation
respirator Initial Final \1\
------------------------------------------------------------------------
For gases, vapors, or gases and
vapors, and dusts, fumes, and
mists........................... 50 70 20
For gases, vapors, or gases and
vapors, and mists of paints,
lacquers, and enamels........... 50 70 20
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 in subpart L
of this part.
(b) Facepiece test. The facepiece test will be conducted as
specified in Sec. 84.205.
(c) Lacquer and enamel mist tests; general. (1) Three respirators
with cartridges containing or having attached to them, filters for
protection against mists of paints, lacquers, and enamels shall be
tested in accordance with the provisions of paragraph (f) of this
section.
(2) In addition to the test requirements set forth in paragraph
(c)(1) of this section, three such respirators will be tested against
each aerosol in accordance with the provisions of paragraphs (d) and
(e) of this section.
(d) Lacquer mist test. (1) Temperature in the test chamber will be
approximately 25 deg. C.
(2) Continuous airflow through the respirator will be 32 liters per
minute for air-purifying respirators, and not less than 115 liters per
minute to tight fitting facepieces and 170 liters per minute to
[[Page 30394]] loose-fitting hoods and helmets of powered air-purifying
respirators.
(3) Airflow through the chamber will be 20-25 air changes per
minute.
(4) The atomizer employed will be a No. 64-5 nozzle with setup 3,
or equivalent, operating at 69 kN/m.\2\ (10 pounds per square inch
gage).
(5) The test aerosol will be prepared by atomizing a mixture of one
volume of clear cellulose nitrate lacquer and one volume of lacquer
thinner. The lacquer described in Federal Specification TT-L-31,
October 7, 1953, is an example of an acceptable lacquer. Copies of TT-
L-31 may be inspected or obtained from the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
(6) The concentration of cellulose nitrate in the test aerosol will
be 95-125 milligrams per cubic meter.
(7) The test aerosol will be drawn to each respirator for a total
of 156 minutes for air-purifying respirators and 240 minutes for
powered air-purifying respirators.
(8) The total amount of unretained mist in the samples taken during
testing, weighed as cellulose nitrate, shall not exceed 5 milligrams
for an air-purifying respirator, 28 milligrams for a powered air-
purifying respirator with tight-fitting facepiece, and 41 milligrams
for a powered air-purifying respirator with loose-fitting hood or
helmet.
(e) Enamel mist test. (1) Temperature in the test chamber will be
approximately 25 deg. C.
(2) Continuous airflow through the respirator will be 32 liters per
minute for air-purifying respirators, and not less than 115 liters per
minute to tight-fitting facepieces and 170 liters per minute to loose-
fitting hoods and helmets of powered air-purifying respirators.
(3) Airflow through the chamber will be 20-25 air changes per
minute.
(4) The atomizer employed will be a No. 64 nozzle with setup 1A, or
equivalent, operating at 69 kN/m.2 (10 pounds per square inch
gage).
(5) The test aerosol will be prepared by atomizing a mixture of 1
volume of white enamel and 1 volume of turpentine. The enamel described
in Federal Specification TT-E-489b, May 12, 1953, with amendment-1 of 9
November 1955 is an example of an acceptable enamel. Copies of TT-E-
489b may be inspected or obtained from the NIOSH, Certification and
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
(6) The concentration of pigment in the test aerosol, weighed as
ash, will be 95-125 milligrams per cubic meter.
(7) The test aerosol will be drawn to each respirator for a total
of 156 minutes for air-purifying respirators and 240 minutes for power
air-purifying respirators.
(8) The total amount of unretained mist in the samples taken during
testing, weighed as ash, shall not exceed 1.5 milligrams for any air-
purifying respirator, 8.3 milligrams for a powered air-purifying
respirator with tight-fitting facepiece, and 12.3 milligrams for a
powered air-purifying respirator with loose-fitting hood or helmet.
(f) Bench tests; gas and vapor tests. (1) Bench tests will be made
in accordance with Sec. 84.207 and tested cartridges shall meet the
minimum requirements set forth in Table 11 of subpart L of this part.
Cartridges will be equilibrated in accordance with paragraph (f)(2) of
this section.
(2)(i) Two powered air-purifying cartridges or pairs of cartridges
will be equilibrated at room temperature by passing 25 percent relative
humidity air through them at the following flow rates (expressed in
liters per minute (l.p.m.)) for 6 hours:
------------------------------------------------------------------------
Airflow
Type of cartridge rate,l.p.m.
------------------------------------------------------------------------
Powered air purifying with tight-fitting facepiece......... 115
Powered air purifying with loose-fitting hood or helmet.... 170
------------------------------------------------------------------------
(ii) Two powered air-purifying cartridges or pairs of cartridges
will be equilibrated by passing 85 percent relative humidity air
through them at the flow rates stated in paragraph (f)(2)(i) of this
section.
(iii) All cartridges will be resealed, kept in an upright position,
at room temperatures, and tested within 18 hours.
Sec. 84.1158 Dust, fume, and mist tests; respirators with filters;
minimum requirements; general.
(a) Three respirators with cartridges containing, or having
attached to them, filters for protection against dusts, fumes, and
mists, except the mists of paints, lacquers, and enamels, will be
tested in accordance with the provisions of Sec. 84.1157(f).
(b) In addition to the test requirements set forth in paragraph (a)
of this section, three such respirators will be tested, as appropriate,
in accordance with the provisions of Secs. 84.1141 through 84.1152;
however, the maximum allowable resistance of complete dust, fume, and
mist, and gas, vapor, or gas and vapor chemical cartridge respirators
shall not exceed the maximum allowable limits set forth in
Sec. 84.1157(a)(2).
Tables to Subpart KK of Part 84
Table 12.--Facepiece Test Requirements
[42 CFR Part 84, Subpart KK]
------------------------------------------------------------------------
Pressure Isoamyl acetate test
Respirator types tightness ---------------------------
test \1\ 84.1141 84.1142
------------------------------------------------------------------------
Dusts: Air Contamination Level
not less than 0.05 mg/M3 or 2
mppcf........................ X
Fumes: Air Contamination Level
not less than 0.05 mg/M3..... X X
Mists: Air Contamination Level
not less than 0.05 mg/M3 or 2
mppcf........................ X
Dusts, Fumes, and Mists: Air
Contamination Level less than
0.05 mg/M3 or 2 mppcf, and
radionuclides................ X X
Radon daughters............... X X
Asbestos-containing dusts and
mists........................ X
------------------------------------------------------------------------
\1\ Test is required only where applicable.
[[Page 30395]]
Table 13.--Air-Purifying and Powered Air-Purifying Respirator Filter Tests Required for Approval
[42 CFR Part 84, Subpart KK]
----------------------------------------------------------------------------------------------------------------
Silica dust tests
Respirator types ------------------------------------------ Lead fume Silica mist DOP test
84.1144 84.1145 84.1152 test 84.1146 test 84.1147 84.1151
----------------------------------------------------------------------------------------------------------------
Dusts: Air Contamination
Level not less than 0.05 mg/
M3 or 2 mppcf.............. X
Fumes: Air Contamination
Level not less than 0.05 mg/
M3......................... X
Mists: Air Contamination
Level not less than 0.05 mg/
M3 or 2 mppcf.............. X
Dusts, Fumes, and Mists: Air
Contamination Level less
than 0.05 mg/M3 or 2 mppcf,
and radionuclides.......... X X
Radon daughters............. 1 X 2 X
Asbestos-containing dusts
and mists.................. 2 X 3 X
Single use dust and mist
respirators................ 3 X 3 X
----------------------------------------------------------------------------------------------------------------
\1\ For resistance only.
\2\ For penetration only.
\3\ Test required only where applicable.
Table 14.--Carbon Tetrachloride Bench Tests and Requirements for
Canisters and Cartridges
[42 CFR part 84, Subpart KK]
------------------------------------------------------------------------
Test Minimum
Type of pesticide concentration Flow rate Number of life
respirator p.p.m. CCl4 l.p.m. tests minutes1
------------------------------------------------------------------------
Chest-mounted or
back-mounted gas
mask (as
received)........ 20,000 64 3 12
Chest-mounted or
back-mounted gas
mask
(equilibrated)... 20,000 32 4 12
Chin-style gas
mask (as
received)........ 5,000 64 3 12
Chin-style gas
mask
(equilibrated)... 5,000 32 4 12
Chemical Cartridge
respirator (as
received)........ 1,000 64 3 50
Chemical cartridge
respirator
(equilibrated)... 1,000 32 4 50
Powered air-
purifying
respirator (tight-
fitting
facepiece, as
received)........ 1,000 2 115 3 50
Powered air-
purifying
respirator (tight-
fitting
facepiece,
equilibrated).... 1,000 2 115 4 25
Powered air-
purifying
respirator (loose-
fitting hood or
helmet, as
received)........ 1,000 3 170 3 50
Powered air-
purifying
respirator (loose-
fitting hood or
helmet,
equilibrated).... 1,000 3 170 4 25
------------------------------------------------------------------------
\1\ Minimum life will be determined at 5 p.p.m. leakage.
\2\ The flow rate shall be the effective flow rate of the device, but
shall be not less than 115 l.p.m.
\3\ The flow rate shall be the effective flow rate of the device, but
shall be not less than 170 l.p.m.
Note: The following appendix will not appear in the Code of
Federal Regulations.
Appendix A to Preamble--Comparison of Final Rule to Proposed Rule
------------------------------------------------------------------------
Proposed Final
section section Change from proposal to final
------------------------------------------------------------------------
84.1...... 84.1 No change from proposal.
84.2...... 84.2 No change from proposal.
84.3...... Incorporation by reference section is not
included in the final rule because of format
requirements of the Federal Register.
84.4...... 84.3 No change from proposal.
84.10..... 84.10 No change from proposal.
84.11..... 84.11 No change from proposal.
84.12..... 84.12 No change from proposal.
84.20..... 84.20 No change from proposal.
84.21..... 84.21 No change from proposal.
84.22..... 84.22 No change from proposal.
84.30..... 84.30 No change from proposal.
84.31..... 84.31 No change from proposal.
84.32..... 84.32 No change from proposal.
84.33..... 84.33 No change from proposal.
84.34..... 84.34 No change from proposal.
84.35..... 84.35 No change from proposal.
84.36..... 84.36 No change from proposal.
84.40..... 84.40 No change from proposal.
84.41..... 84.41 Changed from proposal to final rule for new
incorporation by reference wording.
84.42..... 84.42 No change from proposal.
84.43..... 84.43 No change from proposal.
84.50..... 84.50 No change from proposal.
84.51..... 84.51 No change from proposal.
84.52..... 84.52 No change from proposal.
[[Page 30396]]
84.53..... 84.53 No change from proposal.
84.60..... 84.60 No change from proposal.
84.61..... 84.61 No change from proposal.
84.62..... 84.62 No change from proposal.
84.63..... 84.63 No change from proposal.
84.64..... 84.64 No change from proposal.
84.65..... 84.65 No change from proposal.
84.66..... 84.66 No change from proposal.
84.70..... 84.70 No change from proposal.
84.71..... 84.71 No change from proposal.
84.72..... 84.72 No change from proposal.
84.73..... 84.73 No change from proposal.
84.74..... 84.74 No change from proposal.
84.75..... 84.75 No change from proposal.
84.76..... 84.76 Changed from proposal to final rule for new
incorporation by reference wording.
84.77..... 84.77 No change from proposal.
84.78..... 84.78 No change from proposal.
84.79..... 84.79 Changed from proposal to final rule for new
incorporation by reference wording.
84.80..... 84.80 No change from proposal.
84.81..... 84.81 Changed from proposal to final rule for new
incorporation by reference wording.
84.82..... 84.82 No change from proposal.
84.83..... 84.83 No change from proposal.
84.84..... 84.84 No change from proposal.
84.85..... 84.85 No change from proposal.
84.86..... 84.86 No change from proposal.
84.87..... 84.87 No change from proposal.
84.88..... 84.88 Changed from proposal to final rule for new
incorporation by reference wording.
84.89..... 84.89 No change from proposal.
84.90..... 84.90 No change from proposal.
84.91..... 84.91 No change from proposal.
84.92..... 84.92 No change from proposal.
84.93..... 84.93 No change from proposal.
84.94..... 84.94 No change from proposal.
84.95..... 84.95 No change from proposal.
84.96..... 84.96 No change from proposal.
84.97..... 84.97 Changed from proposal to final rule for new
incorporation by reference wording.
84.98..... 84.98 No change from proposal.
84.99..... 84.99 No change from proposal.
84.100.... 84.100 No change from proposal.
84.101.... 84.101 No change from proposal.
84.102.... 84.102 No change from proposal.
84.103.... 84.103 No change from proposal.
84.104.... 84.104 No change from proposal.
84.110.... 84.110 No change from proposal.
84.111.... 84.111 No change from proposal.
84.112.... 84.112 No change from proposal.
84.113.... 84.113 Changed from proposal to final rule for new
incorporation by reference wording.
84.114.... 84.114 No change from proposal.
84.115.... 84.115 No change from proposal.
84.116.... 84.116 No change from proposal.
84.117.... 84.117 No change from proposal.
84.118.... 84.118 No change from proposal.
84.119.... 84.119 Changed from proposal to final rule for new
incorporation by reference wording.
84.120.... 84.120 No change from proposal.
84.121.... 84.121 No change from proposal.
84.122.... 84.122 No change from proposal.
84.123.... 84.123 No change from proposal.
84.124.... 84.124 No change from proposal.
84.125.... 84.125 No change from proposal.
84.126.... 84.126 No change from proposal.
84.130.... 84.130 No change from proposal.
84.131.... 84.131 No change from proposal.
84.132.... 84.132 No change from proposal.
84.133.... 84.133 No change from proposal.
84.134.... 84.134 No change from proposal.
84.135.... 84.135 No change from proposal.
84.136.... 84.136 Changed from proposal to final rule for new
incorporation by reference wording.
84.137.... 84.137 No change from proposal.
84.138.... 84.138 No change from proposal.
84.139.... 84.139 No change from proposal.
84.140.... 84.140 No change from proposal.
[[Page 30397]]
84.141.... 84.141 Changed from proposal to final rule for new
incorporation by reference wording.
84.142.... 84.142 No change from proposal.
84.143.... 84.143 No change from proposal.
84.144.... 84.144 No change from proposal.
84.145.... 84.145 No change from proposal.
84.146.... 84.146 No change from proposal.
84.147.... 84.147 No change from proposal.
84.148.... 84.148 No change from proposal.
84.149.... 84.159 No change from proposal.
84.150.... 84.150 No change from proposal.
84.151.... 84.151 No change from proposal.
84.152.... 84.152 No change from proposal.
84.153.... 84.153 No change from proposal.
84.154.... 84.154 No change from proposal.
84.155.... 84.155 No change from proposal.
84.156.... 84.156 No change from proposal.
84.157.... 84.157 No change from proposal.
84.158.... 84.158 No change from proposal.
84.159.... 84.159 No change from proposal.
84.160.... 84.160 No change from proposal.
84.161.... 84.161 No change from proposal.
84.162.... 84.162 No change from proposal.
84.163.... 84.163 No change from proposal.
84.170.... 84.170 1. Changed to limit requirements to non-powered
air-purifying respirators. Added description of
non-powered air-purifying respirator.
2. Changed classification from ``solid'' and
``liquid and solid'' to ``N-series, R-series,
and P-series.''
3. Changed efficiency level designations from A
(99.97%), B(99%), and C (95%) to N100, R100,
P100 (99.97%), N99, R99, P99(99%), N95, R95,
and P95(95%).
84.171.... 84.171 Changed to limit requirements to non-powered air-
purifying respirators.
84.172.... 84.172 No change from proposal.
84.173.... 84.173 No change from proposal.
84.174.... 84.174 No change from proposal.
84.175.... 84.175 No change from proposal.
84.176.... 84.176 No change from proposal.
84.177.... 84.177 No change from proposal.
84.178.... 84.178 No change from proposal.
84.179.... Air velocity and noise levels for hoods and
helmets is not included in final rule because
these are applicable to powered air-purifying
respirators only.
84.180.... 84.179 1. Changed to limit requirements to non-powered
air-purifying respirators.
2. Changed classification from ``solid'' and
``liquid and solid'' to ``N-series, R-series,
and P-series.''
3. Changed efficiency level designations from A
(99.97%), B(99%), and C (95%) to N100, R100,
P100 (99.97%), N99, R99, P99(99%), N95, R95,
and P95(95%).
4. Changed labelling from S and L&S (e.g., Type
A/L&S) to series and efficiency level (e.g.,
P100 particulate filter (99.97% filter
efficiency level)).
84.181.... Isoamyl acetate tightness test for particulate
respirators with filters not intended to be
replaced is not included in the final rule to
avoid confusion and complications in the
certification process.
84.182.... Isoamyl acetate tightness test for respirators
with replaceable filters is not included in the
final rule to avoid confusion and complications
in the certification process.
84.183.... 84.180 1. Changed to increase initial inhalation
resistance from 30 mm water-column height to 35
mm.
2. Changed to increase initial exhalation
resistance from 20 mm water-column height to 25
mm.
84.184.... 84.181 1. Changed to limit requirements to non-powered
air-purifying respirators.
2. Changed test terminology from filter
penetration to filter efficiency.
3. Changed to reduce the number of tested units
from 30 to 20.
4. Changed the test acceptance criterion from a
statistical treatment of results to a pass/fail
criterion.
5. Changed the tolerances for measurements to
address testing consistency concerns.
6. Changed aerosol loading of tested filters to
add the P-series test until there is no further
decrease in efficiency.
7. Changed the description of dioctyl phthalate
(DOP) aerosol to add a purity requirement.
8. Changed to require only N-series filters
(formerly solid only) to be preconditioned
before testing. The proposal required
precondition of all filters before testing.
84.185.... Powered particulate respirator flow requirements
are not included in the final rule.
84.186.... 84.182 No change from proposal.
84.190.... 84.190 No change from proposal.
84.191.... 84.191 No change from proposal.
84.192.... 84.192 No change from proposal.
84.193.... 84.193 Changed from proposal to final rule for new
incorporation by reference wording.
84.194.... 84.194 No change from proposal.
84.195.... 84.195 No change from proposal.
84.196.... 84.196 No change from proposal.
84.197.... 84.197 No change from proposal.
84.198.... 84.198 No change from proposal.
84.199.... 84.199 No change from proposal.
[[Page 30398]]
84.200.... 84.200 No change from proposal.
84.201.... 84.201 No change from proposal.
84.202.... 84.202 No change from proposal.
84.203.... 84.203 No change from proposal.
84.204.... 84.204 No change from proposal.
84.205.... 84.205 No change from proposal.
84.206.... 84.206 No change from proposal.
84.207.... 84.207 No change from proposal.
84.250.... 84.250 No change from proposal.
84.251.... 84.251 No change from proposal.
84.252.... 84.252 No change from proposal.
84.253.... 84.253 No change from proposal.
84.254.... 84.254 No change from proposal.
84.255.... 84.255 No change from proposal.
84.256.... 84.256 No change from proposal.
84.257.... 84.257 No change from proposal.
84.258.... 84.258 No change from proposal.
------------------------------------------------------------------------
Subpart KK (Dust, Fume, and Mist; Pesticide; Paint Spray;
Powered Air-Purifying High Efficiency Respirators and Combination
Gas Masks) has been added to the final rule to allow needed
applications for extensions of approvals for dust/fume/mist
respirators previously approved under 30 CFR Part 11. This subpart
also includes the requirements for powered air-purifying
respirators.
84.1100 Scope and effective dates.
84.1101 Definitions.
84.1102 Examination, inspection and testing of complete respirator
assemblies; fees.
84.1103 Approval labels and markings; approval of contents; use.
84.1130 Respirators; description.
84.1131 Respirators; required components.
84.1132 Breathing tubes; minimum requirements.
84.1133 Harnesses; installation and construction; minimum
requirements.
84.1134 Respirator containers; minimum requirements.
84.1135 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
84.1136 Facepieces, hoods, and helmets; eyepieces; minimum
requirements.
84.1137 Inhalation and exhalation valves; minimum requirements.
84.1138 Head harnesses; minimum requirements.
84.1139 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.1140 Dust, fume, and mist respirators; performance requirements;
general.
84.1141 Isoamyl acetate tightness test; dust, fume, and mist
respirators designed for respiratory protection against fumes of
various metals having an air contamination level not less than 0.05
milligram per cubic meter; minimum requirements.
84.1142 Isoamyl acetate tightness test; respirators designed for
respiratory protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter, or
against radionuclides; minimum requirements.
84.1143 Dust, fume, and mist air-purifying filter tests;
performance requirements; general.
84.1144 Silica dust test for dust, fume, and mist respirators;
single-use or reusable filters; minimum requirements.
84.1145 Silica dust test; non-powered single-use dust respirators;
minimum requirements.
84.1146 Lead fume test for dust, fume, and mist respirators;
minimum requirements.
84.1147 Silica mist test for dust, fume, and mist respirators;
minimum requirements.
84.1148 Tests for respirators designed for respiratory protection
against more than one type of dispersoid; minimum requirements.
84.1149 Airflow resistance tests; all dust, fume, and mist
respirators; minimum requirements.
84.1150 Exhalation valve leakage test; minimum requirements.
84.1151 DOP filter test; respirators designed as respiratory
protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter and
against radionuclides; minimum requirements.
84.1152 Silica dust loading test; respirators designed as
protection against dusts, fumes, and mists having an air
contamination level less than 0.05 milligram per cubic meter and
against radionuclides; minimum requirements.
84.1153 Dust, fume, mist, and smoke tests; canister bench tests;
gas mask canisters containing filters; minimum requirements.
84.1154 Canister and cartridge requirements.
84.1155 Filters used with canisters and cartridges; location;
placement.
84.1156 Pesticide respirators; performance requirements; general.
84.1157 Chemical cartridge respirators with particulate filters;
performance requirements; general.
84.1158 Dust, fume, and mist tests; respirators with filters;
minimum requirements; general.
[FR Doc. 95-13287 Filed 6-2-95; 12:10 pm]
BILLING CODE 4160-19-P
