[Federal Register Volume 59, Number 99 (Tuesday, May 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11879]
[[Page Unknown]]
[Federal Register: May 24, 1994]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
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42 CFR Part 84
Respiratory Protective Devices; Proposed Rule
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: Notice of proposed rulemaking.
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SUMMARY: This proposed rule addresses NIOSH's and the Department of
Labor/Mine Safety and Health Administration's (MSHA) certification
requirements for respiratory protective devices. Specifically, the
proposal would replace existing MSHA regulations with new public health
regulations, while also upgrading current testing requirements for
particulate filters.
This action is the first of a series of modules which will, over
the next several years, upgrade current respirator requirements. This
modular approach will allow improvements to be implemented on a
priority basis as well as facilitate adaptation to new requirements by
the manufacturers and users of respirators. Except for the particulate-
filter requirements, most requirements of existing regulations would be
incorporated into the new regulations without change. The proposed
testing requirements for particulate filters would significantly
improve the current approach to evaluating the effectiveness of an air-
purifying respirator's filter to remove toxic particulates from the
ambient air, updating existing provisions to be consistent with two
decades of advances in respiratory protection technology.
The certification of air-purifying respirators under these proposed
requirements would also enable respirator users to select from a
broader range of certified respirators that meet the current
performance criteria recommended by CDC for respiratory devices used in
health-care settings for protection against Mycobacterium tuberculosis,
the infectious agent that causes tuberculosis (TB).
This Notice also announces an informal public meeting on the
proposed rule, as indicated below.
Elsewhere in this issue of the Federal Register, MSHA is publishing
a proposal to remove existing regulations at 30 CFR part 11, which
would be made obsolete by a final rule resulting from this proposed
rule.
DATES: Written comments must be received at the NIOSH Docket Office
before the close of business on July 8, 1994. Interested persons
wishing to provide oral comments at an informal public meeting should
file a request for appearance with the NIOSH Docket Office no later
than the close of business May 31, 1994. The informal public meeting
will be held on June 7th and 8th, 1994, beginning both days at 9 a.m.
ADDRESSES: Comments on the proposed rule should be mailed in triplicate
to the NIOSH Docket Office, Robert A. Taft Laboratories, Mail Stop C34,
4676 Columbia Parkway, Cincinnati, Ohio 45226. Requests to participate
in the public meeting should be mailed in duplicate to the NIOSH Docket
Officer, at the same address. The informal public meeting will be held
at the Holiday Inn/Capitol, 550 C St., SW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, Chief,
Certification and Quality Assurance Branch, Division of Safety
Research, NIOSH, 944 Chestnut Ridge Road, Morgantown, West Virginia
26505-2888; the telephone number is (304) 284-5713. Additional copies
of this proposed rule can be obtained by calling the NIOSH toll-free
information number (1-800-35-NIOSH). Arrangements have also been made
for this proposed 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.
SUPPLEMENTARY INFORMATION:
I. Paperwork Reduction Act
Manufacturers seeking approval of respiratory protective devices
would continue to be required to submit applications for approval,
including related drawings, drawing lists, specifications, and
descriptions. The paperwork burden for this application process is
identical to that included in existing 30 CFR 11.10, previously
approved by the Office of Management and Budget (OMB).
However, those sections containing information collections are
being submitted to OMB for review under section 3504(h) of the
Paperwork Reduction Act of 1980. Other organizations and individuals
desiring to submit comments on the information collections should
direct them to the NIOSH Docket Office and to the Office of Information
and Regulatory Affairs; OMB, New Exectutive Office Building (Room
3208), Washington, DC 20503, ATTN: Desk Officer for HHS/PHS/CDC/NIOSH.
II. Background
The existing rules and procedures in 30 CFR Part 11 for approval of
respiratory-protective devices, or respirators, evolved from rules and
procedures developed by the U.S. Department of the Interior, Bureau of
Mines (BOM). Until 1972, the BOM was solely responsible for testing and
approving respirators. In 1972, Part 11 was published jointly by the
BOM and NIOSH. This regulation replaced the BOM's rules and procedures,
and delineated the responsibilities of the two agencies. Under this
regulation, the BOM evaluated respirator performance, and NIOSH was
responsible for administration of the quality control provisions. The
BOM also tested the safety of electrical components of respirators for
use in potentially explosive atmospheres in underground-gassy mines
(intrinsic safety) under the requirements of 30 CFR part 18.
A Memorandum of Understanding, dated May 30, 1972, between the two
agencies refined their respective roles, and part 11 was amended in
1973. Under this arrangement, NIOSH undertook primary responsibility
for performance testing of respirators. Although all approvals
continued to be issued jointly, the BOM primarily retained only the
responsibility to test for intrinsic safety on the small number of
respirators that had electrical components.
The Mining Enforcement and Safety Administration, MSHA's
predecessor agency, was created in 1974, and the responsibilities of
the BOM under part 11 were transferred to that agency. Since MSHA was
created in 1978, it has continued to test electrical components of
respirators for intrinsic safety. MSHA has issued separate approvals
for respirators meeting the requirements of 30 CFR part 18. While MSHA
currently reviews applications for respirator certifications and has
conducted some product evaluations, laboratory testing, quality
assurance, and product audit for certain respirators, the principal
testing and approval activities specified by part 11 are primarily
conducted by NIOSH. NIOSH is proposing to redesignate the requirements
for the certification of respiratory-protective devices of part 11 to
part 84 of Title 42 (42 CFR part 84) under this action.
Following promulgation of 30 CFR part 11 in 1972, NIOSH began
conducting research in several areas of respiratory protection.
Concurrently, NIOSH began to receive public input concerning the
respirator-certification program.
In December 1977, NIOSH conducted a public meeting to obtain
comments on changes needed in 30 CFR part 11. In 1979, a group of
outside consultants conducted a thorough review of the program. The
report received from those consultants was published by NIOSH for
further consideration by other interested persons, and a public meeting
was held in July 1980 to obtain their comments on the program. In
December 1981, the American National Standards Institute Z88 Committee
on Respiratory Protection commented on 30 CFR part 11. In January 1982,
the Mine Health Research Advisory Committee transmitted its
recommendations to NIOSH for further changes to the program. Since
1982, NIOSH has solicited and investigated reports of problems with
NIOSH/MSHA-certified respirators with the purpose of obtaining direct
public input into the approval program.
Investigations, research, comments, and analyses were considered by
NIOSH and MSHA in preparation of a proposed comprehensive revision to
the approval requirements. These changes to existing requirements and
tests were proposed as a new 42 CFR part 84, which was published on
August 27, 1987 (52 FR 32402). Two public meetings were held to obtain
comments on the proposal (in San Francisco, CA on January 20, 1988, and
in Washington, D.C. on January 27-28, 1988). Two extensions of the
public comment period were issued (52 FR 37639 and 53 FR 5595), with it
ending on March 28, 1988. Concurrent with the publication of the
proposed part 84, MSHA published a notice in the Federal Register (52
FR 32313) proposing the withdrawal of 30 CFR part 11 upon final
publication of 42 CFR part 84. Under that proposal, MSHA would have
retained a consultative role in the approval of respirators used in
mining in order to protect the health and safety of miners,
particularly concerning mine rescue and mine emergency respirators.
During the 7-month comment period following the publication of the
proposed part 84, NIOSH received 271 comments on this comprehensive
proposal. Since receiving these comments, NIOSH has been conducting
investigations and research to consider the technical issues addressed
in these comments. Delays have been experienced in finalizing a revised
part 84 draft as a result of the number and diversity of the comments
received. NIOSH determined that at least four major, and more than one
hundred minor technical and administrative changes to the first
comprehensive proposal would be required to adequately address all the
areas of concern. Consequently, NIOSH has reevaluated its intent to
develop and implement a single, comprehensive revision to the existing
regulation of part 11.
Instead, NIOSH intends to promulgate modifications to the existing
requirements of 30 CFR part 11 in a series of modules. There are
numerous benefits to utilizing a modular approach to promulgate the
anticipated 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, and
3. Public participation in the rulemaking process will be
facilitated by proposing important regulatory changes in individual
segments of separate rulemaking.
The anticipated subjects and sequence of the NIOSH rulemaking,
according to this modular approach are:
------------------------------------------------------------------------
Anticipated
Subject area timetable for
proposed rule
------------------------------------------------------------------------
Particulate Filter Tests.............................. May 1994.
Assigned Protection Factors........................... Late 1994.
Administrative Program (application submittal and Early 1995.
processing, fee structure, etc.).
Quality Assurance Requirements........................ Early 1995.
Gas and Vapor Requirements............................ Mid 1995.
Positive Pressure SCBA Requirements................... Early 1996.
Simulated Workplace Protection Factor Test............ Early 1997.
------------------------------------------------------------------------
NIOSH is proposing a limited revision to the existing requirements
of 30 CFR part 11 in this first ``module'', requiring updated
particulate filter tests. These proposed changes would produce
significant improvements in the level of protection provided to the
wearers of the respiratory protective devices and would enable users to
easily discern the level of protection that can be expected when using
a particular respirator, with little impact on the certification
process. NIOSH estimates that these changes to the particulate filter
requirements will affect approximately 80% of all respirators currently
marketed.
These new filter requirements would update the existing 30 CFR part
11 provisions to provide a particulate efficiency determination and
classification system consistent with advances in respiratory
protection technology. The tests to determine the respirator filter's
particulate efficiency enable classification of the filters on their
ability to inhibit the penetration of particulates of the most
penetrating size. The effectiveness of a device to remove particulates
from the ambient air would be reflected in a three-tiered
classification system based on the filter's demonstrated efficiency.
Classification of the filters in this manner eliminates the need to
test and classify the filter respirator according to composition of
contaminant (e.g., ``dust, fume, and mist'', ``asbestos''), since the
penetration rate for particulates in the atmosphere, regardless of
composition, will not exceed that of the test particulate. To revise
respirator nomenclature to be consistent with this fundamental change
in certification philosophy, the words ``dust, fume and mist'' have
been changed to ``particulate'' in the proposed rule.
NIOSH has long been concerned with the health risks to workers due
to the inappropriate selection and use of dust/mist and dust/fume/mist
respirators. Assigned Protection Factor (APF) values are used in the
respirator selection process to indicate the expected protection level.
NIOSH has considered the possibility of reducing the Assigned
Protection Factor (APF) values given in the NIOSH Guide to Industrial
Respiratory Protection and in the Respirator Decision Logic for dust
and fume respirators to account for filter penetration that can occur,
theoretically, when these respirators are inappropriately used against
aerosols less than 2 micrometers in diameter. On September 15, 1992,
NIOSH prepared a draft report, ``A Performance Evaluation of DM and DFM
Filter Respirators Certified for Protection Against Toxic Dusts, Fumes,
and Mist,'' explaining its concerns and suggested course of action.
NIOSH solicited an external scientific peer review of this draft report
on September 15, 1992. This review did not support an immediate
revision of the APF values. The reviewers recommended that NIOSH
address the concern about excessive filter penetration by incorporating
improved filter-penetration tests into the respirator certification
regulation.
After careful consideration of this issue, NIOSH agrees with the
scientific reviewers that, during the transition period for the
implementation of the provisions contained in this rule, an adjustment
of APF values is unnecessary and may confuse respirator users. NIOSH
will continue to recommend the APF values contained in the NIOSH Guide
to Industrial Respiratory Protection (September 1987) and in the
Respirator Decision Logic (May 1987) for respirators previously
certified under the provisions of 30 CFR part 11. For respirators
certified for protection against particulate exposures under the new
part 84 which would replace the existing Dust/Mist and Dust/Fume/Mist
filter respirators under 30 CFR part 11, NIOSH will be recommending new
APF values that account for the new nomenclature and test criteria.
These new values, updating the recommendations cited above, will be
published in a Respirator User's Notice accompanying publication of
this rule as final. It is anticipated that the module on Assigned
Protection Factors will be proposed in late 1994, at which time public
comment will be solicited.
The current regulation in 30 CFR part 11 was developed to certify
respirators used in mining and general industry. They do not contain
performance requirements for certifying air-purifying respirators
against biological agents. Likewise, the modifications to the current
requirements in this proposed rule were not developed specifically to
certify respirators against biological agents. However, the provisions
of this rule will address an important public health need regarding the
control of Mycobacterium tuberculosis, the causative agent of TB,
transmission in health care and other facilities.
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 has published draft recommendations
revising existing CDC guidelines for preventing the transmission of
tuberculosis in health care facilities, entitled ``Guidelines for
Preventing the Transmission of Tuberculosis in Health-Care Facilities,
Second Edition'', published in the Federal Register on October 12, 1993
(58 FR 52810). This draft enumerates 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 draft is a respirator with a
high efficiency (HEPA) filter. However, all six classes of air-
purifying, particulate respirators to be certified under the provisions
of the new particulate filter tests (filter penetration) would meet or
exceed the performance recommendations contained in the CDC document.
These other classes of air-purifying, particulate respirators are
expected to be markedly less expensive than respirators with HEPA
filters.
Consequently, immediate 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. For this reason, NIOSH is moving
forward with a schedule to publish a final rule pertaining to
particulate filters in late-1994.
III. Public Meeting
The record of the informal public meeting will remain open until
July 8, 1994 to allow interested persons to submit written statements
or comments regarding oral presentations made at the public meeting.
The rule is proposed to be effective as follows:
1. 42 CFR part 84 will be effective 30 days from publication of
this rule as final, and;
2. Sale and distribution of respirators listed as certified under
the provisions of 30 CFR Part 11, subparts K or M will no longer be
authorized effective 2 years from the date of publication of this rule
as final.
NIOSH is specifying an effective date for implementation for the
final rule to allow the introduction of filters demonstrating enhanced
performance as soon as possible. The existing 30 CFR part 11 is
expected to remain in effect for 6 months after this rule becomes final
to provide a transition period for manufacturers to prepare for new 42
CFR part 84 applications. NIOSH believes that this period provides
ample transition time for manufacturers to assemble the information
necessary for application for certification of particulate respirators
under the new part 84. Additionally, 2 years from the date this rule
becomes final, respirators can no longer be distributed or sold as
NIOSH-approved under part 11, subpart K or M, unless they demonstrate
compliance with and are certified under the provisions of the new part
84. This 2-year period was selected to ensure that an ample supply of
respirators remain available for use. NIOSH believes that this
timeframe will provide ample time for manufacturers to have respirators
approved and manufactured in sufficient quantities to meet the demand.
NIOSH specifically requests comments on the appropriateness of a 2-year
phase-in period, as proposed.
The administrative record of this rulemaking will consist of this
May 24, 1994 Notice of Proposed Rulemaking; all other relevant Federal
Register notices; agency records on this subject; all written
submissions made in response to the Notices; and the record of the
informal public meeting. The record of the informal public meeting will
consist of the meeting schedule, transcripts made by NIOSH of the oral
comments at the meeting, any written comments submitted by presenters
at the meeting, and statements or comments regarding oral presentations
made at the public meeting submitted by interested persons within the
allotted comment period. No written submission, or any portion thereof,
made in response to this Notice will be received or held in confidence.
The administrative record of the rulemaking will be made available for
viewing and copying in the NIOSH Docket Office. All requests for any
portion of the administrative record must be submitted in writing.
All interested persons are encouraged to submit written comments to
assure receipt on or before the close of business July 8, 1994, and to
advise the NIOSH Docket Office by the necessary date of their intent to
participate in the informal public meeting. All requests for appearance
at the informal public meeting should contain the name, address, and
telephone number, any business affiliation of the person desiring to
make a presentation, a brief summary of the presentation, and the
approximate time requested for the presentation. NIOSH requests that
oral presentations be limited to 10 minutes. Groups having similar
interests are requested to combine their comments and present them
through a single representative. NIOSH will assign the time available
for the meeting among the persons who properly file a request for
appearance.
After reviewing the submitted summaries and the requests for
appearance, NIOSH will schedule each appearance and notify each
participant by mail or telephone of the time assigned to the person and
the approximate time the person's oral presentation is scheduled to
begin. The meeting schedule will be placed on file in the NIOSH Docket
Office.
The proceedings of the meeting will be transcribed. Any interested
person may, consistent with the orderly conduct of the meeting, record
or otherwise make a transcript of the meeting. Each participant may
present relevant written information, data, or views for inclusion in
the record of the meeting.
Any person who desires to submit an advance written statement may
file three copies with the NIOSH Docket Office. A participant may be
accompanied by a reasonable number of additional persons, space
permitting.
If a participant is not present when his or her presentation is
scheduled to begin, the remaining participants will be heard in order.
At the conclusion of the meeting, an attempt will be made to hear any
scheduled participants who missed his or her assigned time. Interested
persons attending the meeting who did not request an opportunity to
make an oral presentation may be given an opportunity to do so at the
conclusion of the meeting, at the discretion of the presiding officer.
IV. Discussion of Proposed Rule--Testing of Particulate Filters
The BOM was solely responsible for testing and approving
respirators until 1972. In 1972, the existing rules and procedures in
30 CFR part 11 for approval of respiratory protective devices, or
respirators, were published jointly by the BOM and NIOSH. Since 1974,
the Mining Enforcement and Safety Administration (MSHA's predecessor
agency), MSHA, and the Occupational Safety and Health Administration
(OSHA) have regulated the selection, use, and maintenance of
respirators in the workplace under their enforcement authorities. With
this redesignation of the requirements for the certification of
respirators, NIOSH is deleting Secs. 11.2 and 11.21 because these
sections of part 11 have been superseded by OSHA's and MSHA's
respirator workplace regulations. Also, the codification of the
redesignated sections into a non-hyphenated numbering system results in
the deletion of several ``general heading'' sections that contain no
substantive requirements. These include Secs. 11.85, 11.102, 11.124,
11.140, and 11.162.
Existing subpart M of part 11 (Secs. 11.170 through 11.183-7)
addresses the requirements for pesticide respirators. The proposal
eliminates this category and the tests specific to it, leaving subpart
M reserved. The proposal also eliminates all references to subpart M
and pesticides as a classification for approval. Manufacturers can
continue to manufacture and market respirators labelled for use as
pesticide respirators, as well as other contaminant classifications,
based on the testing performed under the proposed filter penetration
test. NIOSH, however, would discontinue issuance of certifications that
classify these respirators as suitable for use against a specific
particulate. The proposed test would provide a suitable determination
as to the effectiveness of the filter element in removing particulates
from the ambient air, regardless of the contaminant.
The existing test requirements in Secs. 11.124-21 through 11.124-24
specify a person wearing the respirator to be exposed to an abrasive
blasting environment in which the blasting agent is composed of 99+
percent free silica (SiO2). The purpose of this requirement was to
determine the adequacy of protection provided in such environments.
Over the past two decades, NIOSH has not conducted these tests which
would pose known or potential health risks of exposure to fractured
crystalline silica to prospective test subjects. These tests have been
replaced administratively. This policy will remain in effect until
these regulatory requirements are addressed in a later module.
The proposed 42 CFR part 84 regulation is generally consistent with
the current MSHA and NIOSH respirator approval program, placing
responsibility for certifying most respirators with NIOSH. MSHA and
NIOSH would continue to jointly review and approve respirators used for
mine emergencies, mine rescue, and the associated service-life plans,
users' manuals, and other documentation. Among the types of devices for
which this role is particularly important are self-contained self-
rescue devices. This preserves MSHA's current role in the certification
of certain respirators whose unique use in mining is an important part
of safeguarding the health and safety of miners. In addition, MSHA
would continue to test electrical and electronic components of
respirators for use in potentially explosive atmospheres in underground
gassy mines and issue a separate MSHA approval under 30 CFR part 18 for
such respirators. In implementing the proposed regulation, NIOSH and
MSHA will develop a new Memorandum of Understanding which will reflect
administrative matters related to respirator approval, including
immediate notification to MSHA of field complaints and identified
deficiencies concerning approved respirators.
With the transfer of part 11 from title 30 to part 84 of title 42,
MSHA and NIOSH would no longer process 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. NIOSH realizes that with this step in the development of part
84, some of the respirators that are currently approved would need to
be modified to meet the new requirements, while some would not.
Additionally, with each step in the modular rulemaking approach being
pursued, an increasing number of respirator designs will be affected by
the new regulation. NIOSH realizes that the incremental implementation
of improved test and performance requirements could cause some
confusion as to which respirators have demonstrated performance to the
improved requirements. To address this possibility, the Institute
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 standard. The
Institute further intends to issue public notices of the new approval
designations to be used for the products demonstrating improved
performance to alert users that such improved standards are available.
Section-by-Section Discussion
All sections redesignated to 42 CFR part 84 without modification
from 30 CFR part 11 are not included in this discussion of the proposed
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, 944
Chestnut Ridge Road, Morgantown, West Virginia 26505-2888,
(3) remove references to subpart M, pesticide respirators, and
tests for protection during abrasive blasting, and
(4) correct nonsubstantive typographical errors and reference the
new part 84 section designations.
The sections redesignated without modification are as follows:
84.1, 84.3, 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, 84.179, 84.186, 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.
These sections, and revisions of these sections, will be subject to
public comment in future rulemaking.
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 would be redesignated and revised from the existing
Sec. 11.3.
The existing definitions for ``air contamination level'',
``Bureau'', ``concentration limits for radionuclides'', ``DOP'',
``MESA'', ``pesticide'', ``radionuclides'', and ``smoke'' would be
deleted. These terms are used in provisions that are modified or
deleted as a result of the filter penetration test changes being
proposed. These definitions would, therefore, become unnecessary.
The existing definition for ``Testing and Certification
Laboratory'' would be modified to reflect the present name of the
organization as the ``Certification and Quality Assurance Branch.''
Section 84.4 Respirators For Mine Rescue or Other Emergency Use In
Mines
This section would be new, and would maintain MSHA's role in the
approval of respirators designed for mine rescue or other mine
emergency use. Under the proposal MSHA and NIOSH would 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 would replace MSHA's existing role as a joint
approver of all respirators.
Paragraph (a) specifies that NIOSH and MSHA would jointly certify
any respirator designed for mine emergencies, mine rescue or other
emergency use in mines. This joint review and certification would
include 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 would jointly address recall
and retrofit matters arising from field complaints or identified
deficiencies concerning any respirators used in the mining environment.
The new Memorandum of Understanding would 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 would be redesignated from existing Sec. 11.10 with
only paragraph (e) modified. Paragraph (e) would retain 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 would 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 would remain unchanged from the
existing policies and practices.
Subpart C--Fees
Section 84.20 Examination, Inspection, and Testing of Complete
Respirator Assemblies; Fees
This section would be redesignated from existing Sec. 11.20, and
modified only to reflect the new particulate filter classification
scheme.
Subpart D--Approval and Disapproval
Section 84.33 Approval Labels and Markings; Approval of Contents; Use
This section would be redesignated from existing Sec. 11.33.
Paragraph (b) would specify the use of the NIOSH emblem on the
approval label, replacing the MSHA emblem.
Paragraph (e) of this section would be modified to identify the
existing ``dust, fume, and mist'' class of respirator as a
``particulate'' respirator. The new designation is consistent with the
proposed testing criteria under which these respirators are certified.
The table in paragraph (e) identifying the approval label requirements
would be modified by the removal of references specific to paint spray
and pesticide respirators, also consistent with the changes associated
with the instantaneous penetration tests.
Subpart F--Classification of Approved Respirators; Scope of
Approval; Atmospheric Hazards; Service Time
Section 84.52 Respiratory Hazards; Classification
This section would be redesignated from existing Sec. 11.52.
It would be modified only to delete paragraph (d). Reference to the
pesticide ``classification'' would no longer be appropriate with the
introduction of the ``particulates'' classification with the new
instantaneous-penetration test.
Subpart G--General Construction and Performance Requirements
Section 84.61 General Construction Requirements
This section would be redesignated from existing Sec. 11.61.
The provision for respirator components to meet the permissibility
requirements of 30 CFR part 18 [paragraph (e)] would be deleted because
MSHA's workplace regulations separately and independently establish
this requirement for certain mining applications. This change would be
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 would be 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. With the exception of the airflow resistance test of
Sec. 84.183, these respirators are required to meet the proposed
requirements specified in Secs. 84.170 through 84.186.
Subpart K--Particulate Respirators
Section 84.170 Particulate Respirators; Description
This section would be derived from existing Sec. 11.130. It would
be revised to define particulate respirators in a more concise way than
previously provided for those designed for protection against dusts,
fumes, and mists.
Paragraph (a) would describe particulate air-purifying respirators
as those designed with filters to provide respiratory protection
against atmospheres that: (1) Contain adequate oxygen to support life
and (2) are contaminated with particulates not immediately dangerous to
life or health. The particulates for which protection would be provided
include contaminants such as dusts, fumes, mists and smoke. The
respirator could be designed to remove contaminants, either solid or
both liquid and solid, from the wearer's breathing air.
Paragraph (b) would establish the classification of particulate
air-purifying respirators as either powered or non-powered. Powered
respirators would include those designs where a motor or other device
enhances the air flow of inhalation air through the filter to provide
breathing air to the wearer. Non-powered respirators would 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. Either class of respirator, powered or non-powered, could be
designed and intended for removal of solid particulates only or for
both liquid and solid particulates. A ``liquid only'' category is not
included because a filter that can effectively remove liquid
particulates from the ambient air will also effectively remove solid
particulates.
Paragraphs (c) and (d) would establish the classification of filter
elements used with non-powered and powered air-purifying respirators,
respectively. These classifications are based on the filter's
efficiency in removing particulates from the ambient air as
demonstrated by the test requirements specified in this subpart.
Paragraphs (c)(1) and (d)(1), (c)(2) and (d)(2), and (c)(3) would
define the efficiency level for particulate removal needed to be
achieved in the performance testing for a filter element to be
classified as a Type A, B, or C filter, respectively. A Type A filter
would be required to perform at a minimum efficiency of 99.97%, a Type
B filter at a minimum efficiency of 99%, and a Type C at a minimum
efficiency of 95%.
Section 84.171 Particulate Respirators; Required Components
This section would be redesignated from existing Sec. 11.131,
modified only to incorporate the new terminology of ``particulates'' to
describe dusts, fumes and mists.
Section 84.177 Inhalation and Exhalation Valves; Minimum Requirements
This section would be redesignated from existing Sec. 11.137,
modified only to delete reference to the existing silica dust tests for
single-use respirators of Sec. 11.140-5. The respirator performance
requirements of these existing tests are replaced by the particulate
instantaneous filter penetration test contained in this proposal.
Section 84.180 Particulate Respirators; Filter Type Identification
This section proposes a new classification system for
identification of the efficiency of the filters for particulate
respirators. The new proposed terminology of ``particulate respirator''
would replace the existing ``dust, fume, and mist respirator'', as
discussed previously.
The requirement for the manufacturer to specify the filter-
efficiency/particulate-type classification in the certification
application would be contained in paragraph (a). This classification
would include the type of particulates that the filter is designed to
remove, either solid or both liquid and solid, and the expected
efficiency of the filter based on the test requirements specified in
Sec. 84.184.
The information to be included on the label of a filter for a
certified particulate respirator is specified in paragraphs (b)(1)
through (b)(6). This labeling would define the efficiency level
achieved in the performance testing (i.e., Type A, B, or C filter) and
whether the filter would perform properly in the removal of solid only
(S) or both liquid and solid (L&S) particulates. This information would
be necessary to allow the user to make an informed decision on
selecting the appropriate respiratory protection. To facilitate this
selection process, the Type A, L&S filters are color coded magenta to
allow them to be easily distinguished from the other filter types. The
filters other than Type A, L&S could be of any color, except magenta.
This color coding would be consistent with the present universally-
accepted color-code convention which identifies the best performing
filters (HEPA's) by their magenta color.
Section 84.181 Isoamyl Acetate Tightness Test; Particulate Respirators
With Filters Not Intended To Be Replaced
This section would be redesignated from existing Sec. 11.140-1 with
the test unchanged. Because the proposal would not classify respirators
as designed for protection against fumes from various metals having an
air contamination level not less than 0.05 milligram per cubic meter,
the test would be redirected to evaluate the performance of particulate
respirators with filters not intended to be replaced.
Section 84.182 Isoamyl Acetate Tightness Test; Respirators With
Replaceable Filters; Minimum Requirements
This section would be redesignated from existing Sec. 11.140-2 with
the test unchanged. Because the proposal would not classify respirators
designed for protection against dusts, fumes and mists having an air
contamination level less than 0.05 milligram per cubic meter, or
radionuclides, the test would be redirected to evaluate the performance
of particulate respirators with replaceable filters.
Section 84.183 Airflow-Resistance Tests
Section 84.183 would be redesignated from Sec. 11.140-9, modified
to delete the final inhalation resistance requirements. The proposed
instantaneous-penetration tests are not designed to simulate loading of
the filter at the worksite, and represent a significant change in the
testing philosophy from the existing requirements. Therefore, these
requirements would not be necessary or appropriate with the
introduction of these new tests.
Section 84.184 Particulate Instantaneous-Penetration-Filter Test
This section would be new. Section 84.184 would specify the test
criteria and acceptable performance criteria for the new particulate
instantaneous-penetration-filter test.
Paragraph (a) would require the instantaneous-penetration
efficiency testing of 30 filters of each particulate respirator model.
Testing would be conducted using a solid particulate aerosol or an oil
liquid particulate aerosol for solid particulate certification and both
liquid and solid particulate certification, respectively.
Paragraph (b) would apply to filters having separable air-purifying
elements. All the respirator's air-purifying elements, including the
element's holders and gaskets, are specified to be installed on the
respirator as used when mounted for testing.
Paragraph (c) would require the preconditioning of all air-
purifying elements of the respirators prior to testing. The elements,
removed from their packaging, are placed in an environment of
855 percent relative humidity at 382.5 degrees
celsius (1004.5 degrees fahrenheit) for 251
hours. Following the humidity conditioning, filters are required to be
sealed in a gas-tight container until tested.
Paragraph (d) would apply to filters having non-separable air-
purifying elements. It would require the exhalation valves to be sealed
during the testing. Sealing of the valves would ensure that the test
results were not affected by any valve leakage, if present.
Paragraph (e) would specify the continuous test-aerosol airflow
rates to be used in testing single and paired filters. Respirators with
a single filter are penetration-tested at a continuous airflow rate of
85 liters (3.0 cubic feet) per minute 5 percent. For pairs,
the test-aerosol airflow rate would be 42.5 liters (1.5 cubic feet) per
minute 5 percent through each filter. This airflow rate is
representative of a high work rate. These test conditions would ensure
that a sufficient number of particulates are applied to the filter
during the test period to provide an adequate indication of the
efficiency of the filters.
Paragraph (f) would specify the test criteria for powered air-
purifying particulate respirators (PAPRs). The PAPRs are penetration
tested while operating in their routine operational mode. This would
require fully-charged batteries, if so equipped, or at normal line
voltage, if line-powered. PAPRs with loose fitting facepieces are
tested in a free-flow mode, while those with tight-fitting facepieces
are tested on a headform connected to a breathing machine or equivalent
breathing device. The breathing machine would have a workrate cam of
622 kp-m/min. operated at a rate of 24 respirations per minute with a
minute volume of 40 liters.
Paragraph (g) would describe the penetration test aerosols and the
test criteria to be used. A sodium chloride solid aerosol would be used
when testing for filter leakage of solid particulate aerosols. A
neutralized-dioctyl phthalate (DOP), or equivalent oil, liquid aerosol
would be specified as the testing agent when testing for filter leakage
of liquid particulate aerosols. The penetration test would be continued
until maximum penetration is achieved or until an aerosol mass of at
least 2005 mg for non-powered respirators, or at least
2,00050 mg for powered air-purifying respirators, has
contacted the filter unit.
Paragraph (g)(1) would identify the test conditions for the sodium
chloride solid aerosol to be at 255 degrees celsius
(779 degrees fahrenheit) and relative humidity of less than
30 percent. The aerosol specified to be used in these tests would be
neutralized to the Boltzmann equilibrium state, and the maximum
concentration would not exceed 200 mg/m\3\.
Paragraph (g)(2) would specify the DOP or equivalent oil, liquid
particulate aerosol. The test conditions for the liquid aerosol are
specified to be at 255 degrees celsius. The aerosol
specified to be used in these tests would be neutralized to the
Boltzmann equilibrium state, and the maximum concentration would not
exceed 200 mg/m\3\.
Paragraph (h) would specify the particle size limitations at the
test conditions for the filter-penetration-test aerosols. The sodium
chloride aerosol would have a particle size distribution with count
median diameter between 0.06 and 0.11 micrometer and a standard
geometric deviation not exceeding 1.84. The liquid particulate aerosol
would have a particle size distribution with count median diameter
between 0.17 and 0.22 micrometer and a standard geometric deviation not
exceeding 1.60. These particle size distribution values would be
determined at the specified test conditions with a differential
mobility particle sizer.
Paragraph (i) would require the instantaneous penetration 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 (j) would require the maximum filter penetration for each
of the 30 filters to be determined and recorded. The mean maximum
penetration, m, and the standard deviation, s, would be required to be
calculated from these data. The test static U for the particulate
respirator filter would be calculated as the sum of the mean maximum
penetration and 2.22 multiplied by the standard deviation. The test
static would be used to determine if the performance of the filter
would meet the requirement for the requested classification (type). For
a type A filter, the test static would be less than or equal to 0.0003;
for a type B, the test static would be less than or equal to 0.01; for
a type C, the test static would be less than or equal to 0.05.
Section 84.185 Powered, Particulate Respirator Flow Requirements
This section would be new. It would specify the minimum
requirements and criteria for verification of the airflow rates of
powered, particulate respirators. This section would also define the
classes as loose-fitting and tight-fitting, depending on their reliance
on the tightness of the face seal.
The airflow of a powered air-purifying respirator would be measured
after each of the penetration tests. The airflow requirements that a
powered air-purifying respirator would be required to meet are
specified based on its design classification as tight-fitting or loose-
fitting. The minimum airflow requirements for each class are specified
in paragraphs (a) and (b) of this section. A tight-fitting, powered,
air-purifying respirator would be defined as designed to seal to the
wearer's face and provide protection as a non-powered respirator in the
event of a blower failure. A loose-fitting, powered, air-purifying
respirator would be defined as designed to function without reliance on
a tight-fitting face seal.
Paragraph (a) would require tight-fitting, powered air-purifying
respirators to maintain an air-flow rate of at least 115 liters (4.06
cubic feet) per minute for a period of at least 4 hours unless
otherwise specified.
Paragraph (b) would require loose-fitting, powered air-purifying
respirators to maintain an air-flow rate of at least 170 liters (6.0
cubic feet) per minute for a period of at least 4 hours, unless
otherwise specified.
Paragraph (c) would require powered air-purifying respirators to be
provided with an acceptable mechanism and appropriate instructions,
whereby, the user can routinely and simply determine that the minimum
airflow is maintained.
Subpart L--Chemical Cartridge Respirators
Section 84.203 Breathing Resistance Tests; Minimum Requirements
This section would be redesignated from existing Sec. 11.162-1.
It would be modified only to delete reference to various
``classifications'', such as paints and pneumoconiosis and fibrous
producing dusts, that would no longer be 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 would be redesignated from existing Sec. 11.162-7. It
would be modified only to delete reference to various
``classifications'', such as paints and pneumoconiosis and fibrous
producing dusts, that would no longer be appropriate with the
introduction of the ``particulates'' classification with the new
instantaneous-penetration test.
Derivation Table
The following derivation table lists: (1) Each section number of
the proposed 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
------------------------------------------------------------------------
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
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............................. 11.139
84.180............................. New.
84.181............................. 11.140-1
84.182............................. 11.140-2
84.183............................. 11.140.9
84.184............................. New.
84.185............................. New.
84.186............................. 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
------------------------------------------------------------------------
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 proposed rule (New Section).
Distribution Table
------------------------------------------------------------------------
Old section New section
------------------------------------------------------------------------
11.1............................... 84.1
11.2............................... Removed.
11.2-1............................. Removed.
11.3............................... 84.2
11.4............................... 84.3
11.10.............................. 84.10
11.11.............................. 84.11
11.12.............................. 84.12
11.20.............................. 84.20
11.21.............................. 84.21
11.22.............................. 84.22
11.30.............................. 84.30
11.31.............................. 84.31
11.32.............................. 84.32
11.33.............................. 84.33
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
11.92.............................. 84.112
11.93.............................. 84.113
11.94.............................. 84.114
11.95.............................. 84.115
11.96.............................. 84.116
11.97.............................. 84.117
11.98.............................. 84.118
11.99.............................. 84.119
11.100............................. 84.120
11.101............................. 84.121
11.102............................. Removed.
11.102-1........................... 84.122
11.102-2........................... 84.123
11.102-3........................... 84.124
11.102-4........................... 84.125
11.102-5........................... 84.126
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
11.131............................. 84.171
11.132............................. 84.172
11.133............................. 84.173
11.134............................. 84.174
11.135............................. 84.175
11.136............................. 84.176
11.137............................. 84.177
11.138............................. 84.178
11.139............................. 84.179
11.140............................. Removed.
11.140-1........................... 84.181
11.140-2........................... 84.182
11.140-3........................... 84.183
11.140-4........................... Removed.
11.140-5........................... Removed.
11.140-6........................... Removed.
11.140-7........................... Removed.
11.140-8........................... Removed.
11.140-9........................... 84.183
11.140-10.......................... 84.146
11.140-11.......................... Removed.
11.140-12.......................... Removed.
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............................. Removed.
11.162-1........................... 84.203
11.162-2........................... 84.204
11.162-3........................... 84.205
11.162-4........................... Removed.
11.162-5........................... Removed.
11.162-6........................... Removed.
11.162-7........................... 84.206
11.162-8........................... 84.207
11.170............................. Removed.
11.171............................. Removed.
11.172............................. Removed.
11.173............................. Removed.
11.174............................. Removed.
11.175............................. Removed.
11.176............................. Removed.
11.177............................. Removed.
11.178............................. Removed.
11.179............................. Removed.
11.180............................. Removed.
11.181............................. Removed.
11.182............................. Removed.
11.183............................. Removed.
11.183-1........................... Removed.
11.183-2........................... Removed.
11.183-3........................... Removed.
11.183-4........................... Removed.
11.183-5........................... Removed.
11.183-6........................... Removed.
11.183-7........................... Removed.
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
------------------------------------------------------------------------
V. Executive Order 12866 and Regulatory Flexibility Act
Section 1 of Executive Order 12866 requires that before the
Department promulgates a new regulation, the need for the regulation
must be assessed, alternatives identified and assessed, the regulations
designed to achieve their 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 Department is
proposing these changes in compliance with both sections of the
Executive Order.
The Department generally prepares a regulatory flexibility
analysis, in accordance with the Regulatory Flexibility Act, if the
rule is expected to have a significant impact on a substantial number
of small entities. That Act also requires that the Department
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.
The Department does not believe that this proposal is
``economically significant'' within the definition of E.O. 12866 (e.g.,
it would not have an effect on the economy of $100 million). Nor does
the Department believe that the proposal will have a significant impact
on a substantial number of small firms. However, it will create costs
for some firms in the respirator industry, and benefits for hospitals
and other entities using respirators. The magnitude of these effects is
uncertain. Accordingly, the Department has prepared the following
voluntary Initial Regulatory Flexibility Analysis.
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 minuscule particles.
This proposal will remove 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 low-cost Class B and Class C respirators (respirators
already using high efficiency filters meeting Class A requirements will
not be affected by this proposal).
It is our understanding that substituting better filter material
will have negligible effects on the costs of filters, over the long
run. The material may cost very slightly more, but its cost will remain
measured in pennies per filter. NIOSH specifically solicits comments
and data for projected estimates of cost for materials and labor for
these improved respirators.
The demonstrated level of performance for filters will, however, 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 CDC 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 CDC 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.
The Department would expect similar effects--both improved health
and cost avoidance--in many other settings. The Department does not
have any basis at this time for quantifying either benefits or costs.
The Department does know 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. The
Department requests comments on potential savings in other settings.
There are approximately 35 manufacturers of these devices. NIOSH
believes that most of these already possess or have access to test
equipment needed to perform the new filter tests the Department
proposes to require. As is currently required under 30 CFR part 11,
NIOSH would 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.
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, the Department does realize that additional
development and redesign costs may be incurred to augment the presently
available products. NIOSH specifically requests relevant data and
comments on projected costs of redesign of respirators.
Notwithstanding these general conclusions, there may be some
manufacturers that will find it financially difficult, or a poor
investment, to meet the new standards. The Department would expect such
problems to result from free market competition rather than the
specific standards of these proposed 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. Nonetheless, there may be regulatory
alternatives that would minimize burdens on the smallest firms and the
Department welcomes suggestions for these.
List of Subjects in 42 CFR Part 84
Labeling, Mine safety and health, Occupational safety and health,
Personal protective equipment, Reporting and recordkeeping
requirements, Respirators.
Dated: February 14, 1994.
Philip R. Lee,
Assistant Secretary for Health.
Approved: March 8, 1994.
Donna E. Shalala,
Secretary.
For the reasons set out in the preamble, 42 CFR part 84 is proposed
to be 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 Incorporation by reference.
84.4 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 Sub-Part 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.
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--Particulate Respirators
84.170 Particulate respirators; description.
84.171 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 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.180 Particulate respirators; filter type identification.
84.181 Isoamyl acetate tightness test; particulate respirators with
filters not intended to be replaced.
84.182 Isoamyl acetate tightness test; respirators with replaceable
filters; minimum requirements.
84.183 Airflow resistance tests.
84.184 Particulate instantaneous-penetration-filter test.
84.185 Powered, particulate respirator flow requirements.
84.186 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.
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 84, 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 84.
(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, 944 Chestnut
Ridge 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 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 Incorporation by reference.
Note: The technical publications referenced in this part 84,
which have been prepared by organizations other than the Institute,
were approved for incorporation by reference in 30 CFR part 11. The
Institute will be submitting these publications for approval of the
incorporation by reference by the Director of the Office of the
Federal Register under this part 84 prior to the publication of a
final rule.
Sec. 84.4 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.
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
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:
All Types................................................... 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 84. 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 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
respirator. or instruction card.
Particulate ......do.................. Respirator container
respirator. and 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 modification 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.
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-105D, ``Sampling
Procedures and Tables for Inspection by Attributes,'' or Military
Standard MIL-STD-414, ``Sampling Procedures and Tables for Inspection
by Variables for Percent Defective,'' or an approved equivalent
sampling procedure, or an approved combination of sampling procedures.
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 II as described in MIL-STD-105D, or inspection level IV as
described in MIL-STD-414, shall be used for major and minor
characteristics and 100 percent inspection for critical
characteristics.
(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 insure 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.
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 insuring 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 insure 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-105D or MIL-
STD-414, or an approved equivalent sampling procedure.
(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 insure effective
quality control over the respirator for which the approval was issued.
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 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 84.
(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
84 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, 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 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 meet the
impact and penetration requirements specified in Federal Specification,
Mask, Air Line, and Respirator, Air Filtering, Industrial, GGG-M-125d,
October 11, 1965. This Federal Specification is available from the
Government Printing Office or the General Services Administration.
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 meet the minimum
requirements for medical or breathing oxygen set forth in the U.S.
Pharmacopeia.
(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
(Grade D or higher quality).
(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
(Grade B or higher quality).
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
National Standard for Compressed Gas Cylinder Valve Outlet and Inlet
Connections, B57.1 (1965), obtainable from American National Standards
Institute, Inc., 1430 Broadway, New York, NY 10018.
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;
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 kg.-m./min.
will be used.\1\
---------------------------------------------------------------------------
\1\Silverman, L., G. Lee, T. Plotkin, L. Amory, and A. R.
Yancey, Fundamental Factors in Design of Protective Equipment,
O.S.R.D. Report No. 5732, issued Apr. 1, 1945. The dimensions of the
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.
(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.2
---------------------------------------------------------------------------
\2\Kloos, E. J., and J. Lamonica, A Machine-Test Method for
Measuring Carbon Dioxide in the Inspired Air of Self-Contained
Breathing Apparatus. Bureau of Mines Report of Investigations 6865,
1966, 11 pp.
---------------------------------------------------------------------------
(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
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.):
----------------------------------------------------------------------------------------------------------------
Maximum permissible temperature of inspired air
Where percent relative shall not exceed--
Where service life of apparatus is-- humidity of inspired -------------------------------------------------
air is-- deg.F. deg.C.
----------------------------------------------------------------------------------------------------------------
\1/4\ hour or less................... 0-100 135 57
\1/2\ hour to \3/4\ hour............. 0-50 125 52
50-100 \1\110 \1\43
1 to 2 hours......................... 0-50 115 46
50-100 \1\105 \1\41
3 hours.............................. 0-50 110 43
50-100 \1\100 \1\38
4 hours.............................. 0-50 105 41
50-100 \1\95 \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 ............... ............... ............... 2.............. 2.............. 2.............. 2.............. Perform 1 hour
readings. test 2, 3, or
4 times
respectively.
Walks at 4.8 km. 3.............. 5.............. 3.............. 4.............. 8.............. 12............. 18............. ...............
(3 miles) per
hour.
Sampling and ............... ............... 2.............. 2.............. 2.............. 2.............. 2..............
readings.
Walks at 4.8 km. ............... ............... 3.............. 5.............. 8.............. 12............. 18............. ...............
(3 miles) per
hour.
Sampling and ............... ............... 2.............. 2.............. 2.............. 2.............. 2..............
readings.
Walks at 4.8 km. ............... ............... ............... ............... 6.............. 13............. 16............. ...............
(3 miles) per
hour.
Sampling and ............... ............... ............... ............... 2.............. 2.............. 2.............. ...............
readings.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour hours\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and ............... ............... ............... 2.............. 2.............. 2.............. 2.............. 2.
readings.
Walks at 4.8 km. ............... ............... 1.............. 1.............. 3.............. 4.............. 6.............. 10.
(3 miles) per
hour.
Carries 23 kg. ............... ............... 1 time in 2 1 time in 2 2 times in 4 3 times in 6 4 times in 8 5 times in 10
(50 pound) minutes. minutes. minutes. minutes. minutes. minutes.
weight over
overcast.
Walks at 4.8 km. ............... ............... ............... 1.............. 3.............. 3.............. 3.............. 5.
(3 miles) per
hour.
Climbs vertical 1.............. 1.............. 1.............. 1.............. 1.............. 1.............. 1.............. 1.
treadmill\2\
(or equivalent).
Walks at 4.8 km. ............... 1.............. 1.............. ............... ............... 2.............. 3.............. 5.
(3 miles) per
hour.
Climbs vertical ............... 1.............. ............... ............... ............... 1.............. 1.............. 1.
treadmill (or
equivalent).
Sampling and ............... ............... ............... ............... 2.............. 2.............. 2.............. 2.
readings.
Walks at 4.8 km. ............... ............... ............... 2.............. 2.............. 3.............. 5.............. 11.
(3 miles) per
hour.
Climbs vertical ............... ............... ............... 1.............. 1.............. 1.............. 1.............. 1.
treadmill (or
equivalent).
Carries 23 kg. ............... ............... ............... 1 time in 2 3 times in 6 4 times in 8 5 times in 10 5 times in 10
(50 pound) minutes. minutes. minutes. minutes. minutes.
weight over
overcast.
Sampling and ............... ............... 2.............. ............... ............... 2.............. 2.............. 2.
readings.
Walks at 4.8 km. ............... ............... ............... 1.............. 3.............. 3.............. 3..............
(3 miles) per
hour.
Climbs vertical ............... ............... 1.............. ............... 1.............. 1.............. 1.............. Then repeat
treadmill (or above
equivalent). activities
once.
Walks at 4.8 km. ............... ............... 2.............. ............... ............... 2.............. 3..............
(3 miles) per
hour.
Climbs vertical ............... ............... ............... ............... ............... 1.............. 1..............
treadmill (or
equivalent).
Carries 20 kg. 1.............. ............... ............... ............... ............... ............... 2..............
(45 pound)
weight and
walks at 4.8
km. (3 miles)
per hour.
Walks at 4.8 km. 1.............. 2.............. ............... ............... ............... 1.............. 4..............
(3 miles) per
hour.
Sampling and ............... ............... ............... 2.............. 2.............. 2.............. 2..............
readings.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
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 ............... ............... ............... 2.............. 2.............. 2.............. 2.............. (\2\)
readings.
Walks at 4.8 km. ............... ............... 1.............. 1.............. 2.............. 2.............. 3.............. ...............
(3 miles) per
hour.
Runs at 9.7 km. 1.............. 1.............. 1.............. 1.............. 1.............. 1.............. 1.............. ...............
(6 miles) per
hour.
Pulls 20 kg. (45 ............... 15 times in 1 ............... 30 times in 2 30 times in 2 30 times in 2 60 times in 6 ...............
pound) weight minute. minutes. minutes. minutes. minutes.
to 5 feet.
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 1.............. 1.............. 1.............. 2.............. 2.............. 2.............. 2.............. ...............
and knees.
Sampling and ............... ............... 2.............. ............... 2.............. 2.............. 2.............. ...............
readings.
Runs at 9.7 km. ............... ............... ............... 1.............. 1.............. 1.............. 1.............. ...............
(6 miles) per
hour.
Walks at 4.8 km. ............... ............... ............... ............... 2.............. 8.............. 10............. ...............
(3 miles) per
hour.
Pulls 20 kg. (45 ............... ............... 30 times in 2 ............... 60 times in 6 60 times in 6 60 times in 6 ...............
pound) weight minutes. minutes. minutes. minutes.
to 5 feet.
Sampling and ............... ............... ............... 2.............. ............... 2.............. 2.............. ...............
readings.
Walks at 4.8 km. ............... ............... 1.............. ............... 3.............. 4.............. 10............. ...............
(3 miles) per
hour.
Lies on side.... ............... ............... ............... ............... ............... 2.............. 4.............. ...............
Lies on back.... ............... ............... ............... ............... ............... 2.............. 1.............. ...............
Sampling and ............... ............... ............... ............... 2.............. 2.............. 2.............. ...............
readings.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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-hour apparatus; then perform test No. 1 for 1-hour apparatus.
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 .................. .................. .................. 2................. 2................. 2................. 2................. (2) (3) (4)
readings.
Walks at 4.8 km. (3 .................. .................. .................. 1................. 2................. 2................. 2................. ......... ......... .........
miles) per hour.
Climbs vertical 1................. 1................. 1................. 1................. 1................. 1................. 1................. ......... ......... .........
treadmill (1) (or
equivalent).
Walks at 4.8 km. (3 .................. 1................. 1................. 1................. 2................. 2................. 2................. ......... ......... .........
miles) per hour.
Pulls 20 kg. (45 .................. 30 times in 2 30 times in 2 30 times in 2 60 times in 5 60 times in 5 60 times in 5 ......... ......... .........
pound) weight to 5 minutes. minutes. minutes. minutes. minutes. mins..
feet.
Walks at 4.8 km. (3 .................. .................. 1................. 1................. 1................. 2................. 3................. ......... ......... .........
miles) per hour.
Carries 23 kg. (50 .................. .................. .................. 1 time in 1 minute 1 time in 1 minute 2 times in 3 4 times in 8 mins. ......... ......... .........
pound) weight over minutes.
overcast.
Sampling and .................. .................. 2................. .................. 2................. 2................. 2................. ......... ......... .........
readings.
Walks at 4.8 km. (3 .................. .................. .................. 1................. 3................. 3................. 4................. ......... ......... .........
miles) per hour.
Runs at 9.7 km. (6 .................. 1................. 1................. 1................. 1................. 1................. 1................. ......... ......... .........
miles) per hour.
Carries 23 kg. (50 .................. .................. 1 time in 1 minute 1 time in 1 minute 2 times in 3 4 times in 6 6 times in 9 mins. ......... ......... .........
pound) weight over minutes. minutes.
overcast.
Pulls 20 kg (45 15 times in 1 .................. .................. 15 times in 1 60 times in 5 30 times in 2 36 times in 3 ......... ......... .........
pound) weight to 5 minute. minute. minutes. minutes. mins..
feet.
Sampling and .................. .................. .................. 2................. 2................. 2................. 2................. ......... ......... .........
readings.
Walks at 4.8 km. (3 1................. .................. 1................. .................. .................. 2................. 6................. ......... ......... .........
miles) per hour.
Pulls 20 kg. (45 .................. .................. .................. .................. .................. 60 times in 5 60 times in 5 ......... ......... .........
pound) weight to 5 minutes. mins..
feet.
Carries 20 kg. (45 .................. .................. .................. .................. .................. 3................. 3................. ......... ......... .........
pound) weight and
walks at 4.8 km.
(3 miles) per hour.
Sampling and .................. .................. .................. .................. .................. 2................. 2................. ......... ......... .........
readings.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\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).
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 gas1 2 3
Ammonia
Carbon monoxide
Organic vapor1 2 3
Other gas(es) and vapor(s)1 2 3
Combination of two or more of the above gases and vapors.123
Combination of acid gas, ammonia, carbon monoxide, and organic
vapors.123
Type of chin-style gas mask:
Acid gas1 2 3
Ammonia
Carbon monoxide
Organic vapor1 2 3
Other gas(es) and vapor(s)1 2 3
Combination of two or more of the above gases and vapors.123
Type of escape gas mask:
Acid gas1 2 3 4
Ammonia4
Carbon monoxide
Organic vapor1 2 3 4
Other gas(es) and vapor(s)1 2 3 4
Combination of two or more of the above gases and vapors.1234
1Approval may be for acid gases or organic vapors as a class or for
specific acid gases or organic vapors.
2Not 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.
3Use 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.
4Eye 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 Standard
for Identification of Air Purifying Respirator Canisters and
Cartridges, K 13.1-1973, obtainable from the American National
Standards Institute, Inc.; 1430 Broadway; New York, N.Y. 10018.
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 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 meet the
impact and penetration requirements specified in Federal Specification,
Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d,
October 11, 1965.
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 84.186, except for
the airflow resistance test of Sec. 84.183.
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 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 allowable Minimum
Canister type Test condition Concentration (liters of penetration service life
Gas or vapor (parts per per tests (parts per (minutes)\1\
million) minute) million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (2)64 2 (3) 60
CO 5,000 (4)32 3 (3) 60
CO 3,000 (2)32 3 ........... 60
.................... ............................ ............. ......... ....... (\3\) ............
Combination of 2 or 3 of above
types\5\
Combination of all of above.\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 cm3 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 above.
\6\Test conditions and requirements will be applicable as shown above, 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 allowable Minimum
Canister type Test condition Concentration (liters of penetration service life
Gas or vapor (parts per per tests (parts per (minutes)\1\
million) minute) million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 20,000 (2)64 2 (\3\) 60
CO 5,000 (4)32 3 (3) 60
CO 3,000 (2)32 3 (3) 60
Combination of 2 or 3 of above
types\5\
Combination of all of 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 cm3 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 above.
\6\Test conditions and requirements will be applicable as shown above, 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 allowable Minimum
Canister type Test condition Gas or Concentration (liters of penetration service life
vapor (parts per per tests (parts per (minutes)(1)
million) minute) million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 ......... 3 (\3\) 60
CO 3,000 (5)32 3 (\3\) 60
(2)32
--------------------------------------------------------------------------------------------------------------------------------------------------------
1Minimum life will be determined at the indicated penetration.
2Relative humidity of test atmosphere will be 953pct; temperature of test atmosphere will be 252.5 deg.C.
3Maximum allowable CO penetration will be 385 cm3 during the minimum life. The penetration shall not exceed 500 p/m during this time.
4If effluent temperature exceeds 100 deg.C during this test, the escape gas mask shall be equipped with an effective heat exchanger.
5Relative humidity of test atmosphere will be 953 pct; temperature of test atmosphere entering the test fixture will be 0+2.5 deg.C-0
deg.C.
Subpart J--Supplied-Air Respirators
Sec. 84.130 Supplied-air respirators; description.
(a) 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:
(1) 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.
(2) 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.
(3) 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.
(4) 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.
(5) 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 demand valve
or pressure demand valve, an arrangement for attaching the hose to the
wearer, and a facepiece, hood, or helmet.
(6) 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 meet the impact
and penetration requirements specified in Federal Specification, Mask,
Air Line, and Respirator, Air Filtering, Industrial GGG-M-125d, October
11, 1965.
(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
(Grade D or higher quality).
(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
(Grade B or higher quality).
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.
Figure 1--Apparatus for measuring power required to operate blower. (42
CFR part 84, subpart J, Sec. 84.146)
Note: Figure 1 does not appear here, but is identical to the one
that appears in 30 CFR 11.124-3. The full text will be included and
printed in the final rule.]
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/m2. (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.
(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.
(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.
Airflow......... 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.
Airflow......... ......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 airflow
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.
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.
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--Particulate Respirators
Sec. 84.170 Particulate respirators; description.
(a) Particulate air-purifying respirators have filters to remove
solid or both liquid and solid particulates from the ambient air. They
are designed for use as respiratory protection against atmospheres with
particulate contaminants (e.g., dust, fume, mists) that are not
immediately dangerous to life or health and that contain adequate
oxygen to support life.
(b) Particulate air-purifying respirators are classified as either
non-powered or powered, according to their design and are further
classified into one of two types: those intended for removal of solid
particulates only and those intended for both liquid and solid
particulates.
(c) Non-powered particulate air-purifying respirators are
classified according to the efficiency of the filter element(s) as
tested according to the requirements of this part.
(1) Type A filters shall demonstrate a minimum efficiency of 99.97
percent.
(2) Type B filters shall demonstrate a minimum efficiency of 99
percent.
(3) Type C filters shall demonstrate a minimum efficiency of 95
percent.
(d) Powered particulate air-purifying respirators are classified
according to the efficiency of the filter element(s) as tested
according to the requirements of this part.
(1) Type A filters shall demonstrate a minimum efficiency of 99.97
percent.
(2) Type B filters shall demonstrate a minimum efficiency of 99
percent.
Sec. 84.171 Particulate respirators; required components.
(a) Each 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 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, as determined by the
Institute's facepiece tests in Secs. 84.181 and 84.182.
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 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. 84.180 Particulate respirators; filter type identification.
(a) The respirator manufacturer, as part of the application for
certification, shall specify the filter-efficiency/particulate-type
classification (i.e., 95, 99, or 99.97
percent efficiency against solid or both liquid and solid particulates)
for which certification is being sought.
(b) Filters shall be prominently labeled as follows:
(1) Type A (99.97% efficiency) filters intended for use against
only solid particulates shall be labeled ``Type A/S Particulate
Filter'' and shall be a color other than magenta.
(2) Type A (99.97% efficiency) filters intended for use against
both liquid and solid particulates shall be labeled ``Type A/L&S
Particulate Filter'' and shall be color coded magenta.
(3) Type B (99% efficiency) filters intended for use against only
solid particulates shall be labeled ``Type B/S Particulate Filter'' and
shall be a color other than magenta.
(4) Type B (99% efficiency) filters intended for use against both
liquid and solid particulates shall be labeled ``Type B/L&S Particulate
Filter'' and shall be a color other that magenta.
(5) Type C (95% efficiency) filters intended for use against only
solid particulates shall be labeled as ``Type C/S Particulate Filter''
and shall be a color other that magenta.
(6) Type C (95% efficiency) filters intended for use against both
liquid and solid particulates shall be labeled as ``Type C/L&S
Particulate Filter'' and shall be a color other than magenta.
Sec. 84.181 Isoamyl acetate tightness test; particulate respirators
with filters not intended to be replaced.
(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. 84.182 Isoamyl acetate tightness test; respirators with
replaceable filters; 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. 84.183 Airflow-resistance tests.
(a) Resistance to airflow shall be measured in the facepiece,
mouthpiece, hood, or helmet of a particulate respirator (complete
respirator) mounted on a test fixture with air flowing at a continuous
rate of 85 liters (3.0 cubic feet) per minute, before each test
conducted in accordance with Sec. 84.184.
(b) The resistances for particulate respirators upon initial
inhalation shall not exceed 30 mm water column height (1.18 inch)
pressure and upon initial exhalation shall not exceed 20 mm water
column height (0.79 inch) pressure.
Sec. 84.184 Particulate instantaneous-penetration-filter test.
(a) Thirty filters of each particulate respirator model shall be
tested for instantaneous penetration efficiency against:
(1) A solid sodium chloride particulate aerosol as per this section
if solid particulate certification only is requested by the applicant.
(2) A dioctyl phthalate or equivalent oil liquid particulate
aerosol as per this section if both liquid and solid particulate
certification is requested by the applicant.
(b) Air-purifying elements of the respirators including the
element's holders and gaskets; when separable, shall be tested for
instantaneous filter leakage as mounted on a test fixture that
incorporates the connector in the manner as used on the respirator.
(c) Prior to penetration testing, all air-purifying elements of
particulate filter respirators shall be taken out of their packaging
and placed in an environment of 855 percent relative
humidity at 382.5 deg.C (1004.5 deg.F) for
251 hours. Following the humidity conditioning, filters
shall be sealed in a gas-tight container until tested.
(d) When the air-purifying elements are not separable, the
exhalation valves shall be blocked so as to ensure that leakage, if
present, is not included in the filter penetration evaluation.
(e) For air-purifying respirators with a single filter, filters
shall be penetration tested at a continuous airflow rate of 85 liters
(3.0 cubic feet) per minute 5 percent. Where filters are to
be used in pairs, the test-aerosol airflow rate shall be 42.5 liters
(1.5 cubic feet) per minute 5 percent through each filter.
(f) Powered air-purifying particulate respirators (PAPRs) shall be
penetration tested while operating in their routine operational mode
(with fully-charged batteries if they possess battery packs or at
normal line voltage, if line-powered). Powered air-purifying
respirators with loose fitting facepieces shall be tested in a free-
flow mode. Powered air-purifying respirators with tight fitting
facepieces shall be tested on a headform connected to a breathing
machine operated at a rate of 24 respirations per minute with a minute
volume of 40 liters and equipped with a workrate cam of 622 kp-m/min or
equivalent breathing device. The airflow of a powered air-purifying
respirator will be measured after each of the penetration tests and it
shall meet the airflow requirements of Sec. 84.185 of this Subpart.
(g) Penetration test aerosols.
(1) When testing for filter leakage of solid particulate aerosols,
a sodium chloride solid aerosol at 255 deg.C
(779 deg.F) and relative humidity of less than 30 percent
that has been neutralized to the Boltzmann equilibrium state shall be
used. Each respirator filter unit shall be challenged with a
concentration not exceeding 200 mg/m\3\. For nonpowered respirators,
the penetration test shall continue until maximum penetration is
achieved or until an aerosol mass of at least 2005 mg has
contacted the filter unit. For powered air-purifying respirators, the
penetration test shall continue until maximum penetration is achieved
or until a mass of at least 2,00050 mg has contacted the
filter unit.
(2) When testing for filter leakage of oil liquid particulate
aerosols, a dioctyl phthalate (DOP) or equivalent oil at
255 deg.C that has been neutralized to the Boltzmann
equilibrium state shall be used. Each respirator filter unit shall be
challenged with a concentration not exceeding 200 mg/m\3\. For non-
powered respirators, the penetration test shall continue until maximum
penetration is achieved or until an aerosol mass of at least
2005 mg has contacted the filter unit. For powered air-
purifying respirators, the penetration test shall continue until a
maximum penetration is achieved or until a mass of at least
2,00050 mg has contacted the filter unit.
(h) The sodium chloride test aerosol shall have a particle size
distribution with count median diameter between 0.06 and 0.11
micrometer and a standard geometric deviation not exceeding 1.86 at the
specified test conditions as determined with a differential mobility
particle sizer. The liquid particulate test aerosol shall have a
particle size distribution with count median diameter between 0.17 and
0.22 micrometer and a standard geometric deviation not exceeding 1.60
at the specified test conditions as determined with a differential
mobility particle sizer.
(i) The instantaneous penetration of the filter shall be monitored
and recorded throughout the test period by a suitable forward-light-
scattering photometer or equivalent instrumentation.
(j) The maximum filter penetration for each of the 30 filters shall
be determined and recorded. The mean maximum penetration, m, and the
standard deviation, s, shall be calculated. The particulate respirator
filter shall be considered as meeting the requirement of this Subpart
if the test static U meets the following condition:
U=m+2.22s0.0003 type A.
U=m+2.22s0.01 type B.
U=m+2.22s0.05 type C.
Sec. 84.185 Powered, particulate respirator flow requirements.
Powered, air-purifying respirators shall be classified as tight-
fitting or loose-fitting depending on their design. Tight-fitting,
powered, air-purifying respirators shall be designed to seal to the
wearer's face and shall provide protection as a non-powered respirator
in the event of a blower failure. Loose-fitting, powered, air-purifying
respirators shall be designed to function without reliance on a tight-
fitting faceseal. The minimum airflow requirements for each class is as
follows:
(a) Tight-fitting, powered, air-purifying respirators shall
maintain an airflow rate of at least 115 liters (4.06 cubic feet) per
minute for a period of at least 4 hours unless otherwise specified.
(b) Loose-fitting, powered, air-purifying respirators shall
maintain an airflow rate of at least 170 liters (6.0 cubic feet) per
minute for a period of at least 4 hours unless otherwise specified.
(c) Powered, air-purifying respirators shall be provided with an
acceptable mechanism and appropriate instructions whereby the user can
routinely and simply determine that the minimum airflow is maintained.
Sec. 84.186 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 Standard for
Identification of Gas Mask Canisters, K13.1, obtainable from American
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018.
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 respirator -------------------- Exhalation
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 20
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.
\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. 84.180 through 84.186;
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 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.
------------------------------------------------------------------------
Air purifying................................................. 25
Powered air purifying with tight-fitting facepiece............ 115
Powered air purifying with loose-fitting hood or helmet....... 170
------------------------------------------------------------------------
(e) Two cartridges or pairs of cartridges will be equilibrated by
passing 85 percent relative humidity air through them at the flow rates
stated in paragraph (d) of this section.
(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 Gas or Concentration (l.p.m.) tests (p.p.m.)\1\ life\2\
vapor (p.p.m.) (minutes)
----------------------------------------------------------------------------------------------------------------
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 As received.... HCl 500 64 3 5 50
chloride.
Hydrogen Equilibrated... HCl 500 32 4 5 50
chloride.
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.
\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 85 5 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 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
[FR Doc. 94-11879 Filed 5-19-94; 9:44 am]
BILLING CODE 4160-19-P
