[Federal Register Volume 60, Number 110 (Thursday, June 8, 1995)]
[Rules and Regulations]
[Pages 30336-30398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13287]




[[Page 30335]]

_______________________________________________________________________

Part II

Department of Health and Human Services
Public Health Service



42 CFR Part 84

Department of Labor
Mine Safety and Health Administration



30 CFR Parts 11, 49, 56, 57, 58, 70, 72, and 75

Department of Labor
Mine Safety and Health Administration

Department of Health and Human Services
Centers for Disease Control and Prevention
_______________________________________________________________________



Respiratory Protective Devices; Final Rules and Notice

Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules 
and Regulations  
[[Page 30336]] 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 84

RIN 0905-AB58


Respiratory Protective Devices

AGENCY: National Institute for Occupational Safety and Health (NIOSH), 
Centers for Disease Control and Prevention, Public Health Service, HHS.

ACTION: Final rule.

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

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

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

SUPPLEMENTARY INFORMATION:

I. Availability of Copies and Access to Final Rule

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

II. Paperwork Reduction Act

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

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

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

III. Background

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

IV. Summary of Major Changes in Response to Comments

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

V. Administrative and Procedural Matters of Final Rule

A. Modular Approach

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

B. User's Guide

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

C. Use of Particulate Respirators for Protection Against TB

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

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

    Since 1974, the Mine Enforcement and Safety Administration (MESA), 
MSHA, and the Occupational Safety and Health Administration (OSHA) have 
regulated the selection, use, and maintenance of respirators in the 
workplace under their respective enforcement authorities. NIOSH is not 
including the requirements of Secs. 11.2 and 11.2-1 with this 
redesignation to 42 CFR part 84. Sections 11.2(a) and 11.2-1 refer to 
respirator use and selection criteria that since have been superseded 
by OSHA and MSHA respirator regulations.
    Section 11.2(b) allows for the continued manufacture and sale of 
gas masks approved under the former U.S. Bureau of Mines (BOM) Schedule 
14F (dated April 23, 1955). This Schedule was replaced by the 
requirements in Subpart I of 30 CFR part 11 in 1972. Gas masks approved 
under Subpart I of 30 CFR part 11 (14G canisters) are widely available 
and only a limited number of types of 14F canisters are marketed. MSHA 
experience indicates that few of the 14F respirators are currently sold 
or used. MSHA also indicated that removal of the provisions in 
Sec. 11.2(b) would remove the authority to market these respirators as 
approved devices.
    NIOSH is not transferring the requirements of Sec. 11.2(b) to 42 
CFR Part 84 since NIOSH does not have the capability to process 
applications for these respirators. The approval records on these BOM-
approved respirators no longer exist and therefore NIOSH has no way of 
monitoring the production of these respirators to assure that they 
continue to meet the approved design. Thus, NIOSH will not authorize 
the sale and shipment of the Schedule 14F respirators under this part 
84.
    In addition, the codification of the redesignated sections into a 
non-hyphenated numbering system results in several general heading 
sections that contained no substantive requirements [[Page 30339]] not 
being included in this redesignation. These include Secs. 11.85, 
11.102, 11.124, 11.140, and 11.162.
    NIOSH is making a limited revision to the existing requirements of 
30 CFR part 11 in this first module, requiring updated particulate 
filter tests. This revision eliminates the need for unique tests for 
particulate respirators used for different types of aerosols, such as 
dust/mist, dust/fume/mist, paint spray, and pesticides. The new 
certification tests use the most penetrating aerosol size, 
0.3<greek-m>m, and either a non-degrading particulate, sodium chloride, 
or a highly degrading oil, dioctylphthalate. Consequently, particulate 
filters certified under these new procedures can be used without regard 
to aerosol size, taking into consideration only the degrading or 
nondegrading nature of particulates and the APF required by exposure 
concentrations. To revise respirator nomenclature to be consistent with 
this fundamental change in certification philosophy, the words dust, 
fume and mist are replaced with particulate in the final rule.
    Existing subpart M of part 11 (Secs. 11.170 through 11.183-7) 
addresses the requirements for pesticide respirators. The requirements 
of subpart M are not included in this redesignation to 42 CFR part 84. 
This rule eliminates this category and the tests specific to it, 
leaving subpart M reserved. All references to subpart M and pesticides 
as a classification for approval are eliminated. NIOSH will discontinue 
issuance of certifications that classify these respirators as suitable 
for use against a specific particulate.
    The existing test requirements in Secs. 11.124-21 through 11.124-24 
specify that a test subject wearing the respirator be exposed to an 
abrasive blasting environment in which the blasting agent is composed 
of 99+ percent free silica (SiO<INF>2). This requirement is not 
included in this redesignation to 42 CFR part 84. The purpose of this 
requirement was to determine the adequacy of protection provided in 
such environments. NIOSH administratively suspended such tests over 20 
years ago because they placed test subjects at risk of exposure to 
fractured crystalline silica. These tests are not included in this 
final rule. Requirements for abrasive blasting and other atmosphere 
supplying respirators as well as fit testing for all respirator types 
will be addressed in a future module. In the interim, NIOSH will 
continue the administrative policy of the past two decades of 
conducting quantitative fit testing in lieu of the tests stipulated in 
Secs. 11.124-21 through 11.124-24.
    Two comments recommended the inclusion of administrative policies 
to the rule. One commenter suggested that Secs. 11.124-21 through 
11.124-24 (referring to air-line respirators) be restored or replaced 
with the current administrative policy of quantitative fit testing. 
Another commenter was concerned that the NIOSH policy of allowing a 
mixed-gas Self Contained Breathing Apparatus for fire fighting was not 
included in the proposed rule. NIOSH agrees with these commenters that 
administrative policies related to specific changes in a module should 
be incorporated. However, the topics of concern to these commenters 
addressed administrative policies in subject areas that were not 
proposed to be changed in this module, therefore, they have not been 
incorporated.
    NIOSH has not included the test procedures of Secs. 11.124-21 
through 11.124-24 due to NIOSH's concern of health risks to test 
subjects during pre-submission testing performed by a manufacturer 
seeking approval of a respirator intended for use in an abrasive 
blasting environment. Although no Type AE or BE respirators have ever 
been certified, Type AE, BE, and CE respirators may be certified for 
use in an abrasive blasting environment. These respirators will be 
tested using Air-supplied Respirator Section Test Procedure Number 23 
Abrasive-Blast, Type CE. Copies of this procedure are available from 
the Certification and Quality Assurance Branch, 1095 Willowdale Road, 
Morgantown, West Virginia, 26505-2888.

E. MSHA's Regulatory Role

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

F. Transition Period

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

VI. Discussion of Final Rule

A. Certification Fit Testing

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

B. Powered Air-purifying Particulate Respirators

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

C. Filter Classification

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

------------------------------------------------------------------------
                                                                   Test 
                 Category                     Class   Efficiency   agent
------------------------------------------------------------------------
Solid and liquid..........................  A             99.97   DOP   
[[Page 30342]]
                                                                        
Solid.....................................  A             99.97   NaCl  
Solid and liquid..........................  B             99      DOP   
Solid.....................................  B             99      NaCl  
Solid and liquid..........................  C             95      DOP   
Solid.....................................  C             95      NaCl  
------------------------------------------------------------------------

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

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

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

D. Section-by-Section Discussion.

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

Subpart A--General Provisions

Section 84.2--Definitions

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

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

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

Subpart B--Application for Approval

Section 84.10  Application Procedures

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

Subpart C--Fees

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

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

Subpart D--Approval and Disapproval

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

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

Section 84.52  Respiratory Hazards; Classification

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

Subpart G--General Construction and Performance Requirements

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

Subpart I--Gas Masks

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

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

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

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

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

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

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

Section 84.177  Inhalation and Exhalation Valves; Minimum Requirements

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

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

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

Section 84.180  Airflow Resistance Tests

    Section 84.180 is derived from Sec. 11.140-9. It is modified to 
delete the final inhalation resistance requirements. The non-powered 
air-purifying particulate filter efficiency level determination tests 
are not designed to simulate loading of the filter at the worksite. 
Therefore, these requirements are not appropriate with the introduction 
of these new tests.
    Paragraph (a) provides for determining the inhalation-resistance of 
the complete non-powered air-purifying particulate respirator. This 
value corresponds to the pressure drop across the complete respirator 
mounted on a test fixture with air drawn inward through it at a 
continuous rate of 85<plus-minus>2 liters per minute. Tolerance limits 
have been added to the test flow rates as suggested by commenters.
    The final rule does not include final breathing resistance limits 
as requested in some comments. The final breathing resistances 
previously included in the 30 CFR part 11 requirements were based on 
filters loading and clogging with a silica dust. The loading 
experienced at actual worksites is not represented by such a test. The 
inclusion of final breathing resistances as part of a certification 
would primarily address two concerns. The first is that the breathing 
resistance does not exceed physiological limits or pose undue 
discomfort on the wearer. Wearers will replace filters before breathing 
resistances reach such levels. The second concern is that the filter 
efficiency is still at an acceptable level at the certification final 
resistance value. The filter efficiency level determination 
[[Page 30346]] and respirator classifications provided for in this rule 
are sufficiently severe to alleviate this concern.
    One commenter questioned NIOSH's intent for restricting final 
inhalation resistance for particulate filters used in conjunction with 
chemical cartridges. This commenter pointed to Sec. 84.203 requirements 
which specify maximum allowable final inhalation resistances for these 
combinations. The final inhalation value is to be measured at the end 
of the service life tests for the chemical cartridge portion of the 
combination. NIOSH will continue to measure the initial and final 
inhalation and exhalation resistances of the combination in conjunction 
with the service life test of the chemical cartridge. The inhalation 
and exhalation resistances need not be measured for these combinations 
in conjunction with the particulate efficiency level determination 
tests.
    Paragraph (b) states the inhalation resistance of the complete 
respirator is not to exceed 35 millimeters of water-column height. The 
exhalation resistance of the complete respirator is not to exceed 25 
millimeters of water-column height.
    The proposed rule would have limited the inhalation and exhalation 
resistances to 30 and 20 millimeters of water-column height, 
respectively. Several commenters requested that the values be 
increased. Increased breathing resistance values will permit the 
effective use of presently available filter material in respirators re-
designed to meet the efficiency level determination tests at a 
reasonable cost. Others expressed a concern that respirators with 
higher breathing resistances are less likely to be fitted properly, 
often intentionally due to the discomfort. Commenters expressed that 
this may be true in the health-care profession where the use of 
certified respirators is new.
    The final rule has increased the maximum acceptable breathing 
resistance values slightly from the proposed levels to those suggested 
by commenters. The proposed resistance levels of 30 and 20 millimeters 
of water-column height corresponded to the maximum allowable resistance 
values in part 11 for any particulate respirator. The new resistance 
levels remain below the acceptable limits for some non-particulate 
respirator classes under the existing part 11 provision. For example, 
chemical cartridge respirators, which have use patterns similar to 
particulate filter respirators, have a maximum initial inhalation 
resistance of 40 millimeters water-column height. This increase in 
acceptable breathing resistance for particulate respirators will enable 
manufacturers to produce respirators meeting the new requirements more 
expeditiously and at lower cost than the proposal would have allowed. 
This small increase in maximum allowable breathing resistance for 
particulate respirators does not add substantially to physiologic 
burden for respirator users, and will be compensated by increased 
worker protection provided by the new filter efficiency tests and 
classification system. The acceptable breathing resistance levels for 
the non-particulate respirator classes are not affected.

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

    This section is new and specifies the test criteria and acceptable 
performance criteria for the new non-powered air-purifying particulate 
filter efficiency level determination. This section has been retitled 
from particulate instantaneous-penetration-filter test in response to a 
comment. The new title more appropriately represents the intent of the 
tests in this section to determine the efficiency level of the filters.
    Paragraph (a) requires the filter efficiency testing of 20 filters 
of each non-powered air-purifying particulate respirator model. Testing 
is conducted using a solid sodium chloride or equivalent particulate 
aerosol for N-series certification or a dioctyl phthalate or equivalent 
liquid particulate aerosol for R-series and P-series certification.
    Paragraph (b) requires the filters, including holders and gaskets; 
when separable, to be tested mounted on a test fixture in the manner as 
used on the respirator. This provides for testing of the assembly in a 
configuration as it will be actually used.
    Paragraph (c) describes preconditioning requirements for the 20 N-
series filters to be tested. After removal from their packaging, the 20 
filters are placed in an environment of 85<plus-minus>5 percent 
relative humidity at 38<plus-minus>2.5  deg.C for 25<plus-minus>1 
hours. The filters shall be stored in a gas-tight container until 
tested. Testing for the filter efficiencies must be performed within 10 
hours following preconditioning. These preconditioning requirements 
apply only to N-series filters differing from the proposal which would 
have had filters of each series subjected to preconditioning.
    Paragraph (d) provides for blocking the exhalation valves to ensure 
that any valve leakage is not included in the filter efficiency level 
evaluation. This only applies when the filters do not have separable 
holders and gaskets.
    Paragraph (e) specifies the continuous test aerosol flow rates for 
the filter efficiency testing. Single filters are tested at a rate of 
85<plus-minus>4 liters per minute; filters used in pairs are tested at 
a rate of 42.5 <plus-minus> 2 liters per minute through each filter.
    Paragraph (f) describes the penetration test aerosols and the test 
criteria to be used. A sodium chloride or equivalent solid aerosol is 
used when testing for filter efficiency for N-series filters. A 
neutralized-dioctyl phthalate (DOP), or equivalent oil, liquid aerosol 
is specified as the testing agent when testing for filter efficiency of 
R- and P-series filters. For P-series filters, the filter efficiency 
test will be continued until minimum efficiency is obtained. However, 
for N- and R-series respirators it will be terminated when an aerosol 
mass of 200<plus-minus>5 mg has contacted the filter unit, if minimum 
efficiency has not been obtained.
    Paragraph (f)(1) identifies the test conditions for the sodium 
chloride or equivalent solid aerosol to be at 25<plus-minus>5  deg.C 
and relative humidity of 30<plus-minus>10 percent. The aerosol 
specified to be used in these tests will be neutralized to the 
Boltzmann equilibrium state, and the maximum concentration will not 
exceed 200 mg/m\3\. The relative humidity of the sodium chloride 
aerosol has been changed from the proposal in response to a comment. 
This change, a small increase in the relative humidity of the aerosol, 
allows testing at the values normally encountered with the test 
instruments commonly used.
    Paragraph (f)(2) specifies the DOP or equivalent oil liquid 
particulate aerosol. The test conditions for the liquid aerosol are 
specified to be at 25<plus-minus>5  deg.C. The aerosol specified to be 
used in these tests will be neutralized to the Boltzmann equilibrium 
state, and the maximum concentration will not exceed 200 mg/m\3\.
    Paragraph (g) specifies the particle size limitations at the test 
conditions for the filter efficiency test aerosols. The sodium chloride 
aerosol will have a particle size distribution with count median 
diameter between 0.075<plus-minus>0.020 micrometer and a standard 
geometric deviation not exceeding 1.86. The liquid particulate aerosol 
has a particle size distribution with count median diameter between 
0.185<plus-minus>0.020 micrometer and a standard geometric deviation 
not exceeding 1.60. NIOSH will make these particle size distribution 
determinations at the specified test conditions with a scanning 
mobility particle sizer (SMPS) or equivalent. The specification of a 
scanning mobility particle sizer represents newer technology than the 
[[Page 30347]] differential mobility particle sizer that was specified 
in the proposal. This reference to the newer technology was added in 
response to comments from the public. NIOSH will accept manufacturer's 
size verification data determined by SPMS or an equivalent particle 
sizing instrument that provides particle sizing information consistent 
with an SPMS.
    Paragraph (h) requires the efficiency of the filter (i.e., the 
amount of aerosol particles that pass through the filter) to be 
monitored and recorded throughout the test period by a suitable 
forward-light-scattering photometer or equivalent instrumentation.
    Paragraph (i) requires the minimum filter efficiency for each of 
the 20 filters to be determined and recorded. The minimum efficiency of 
each tested filter is to be greater than or equal to 99.97% for P100, 
R100 and N100 filters; 99% for P99, R99 and N99 filters; and 95% for 
P95, R95 and N95 filters.
    Many comments were received on all aspects of the testing 
requirements. Comments were received regarding the proposed loading 
levels, test agents, preconditioning requirements, number of filters to 
be tested, and test equipment specifications.
    The proposal included a statistical treatment of the filter 
efficiency test results (U statistic). Thirty filter samples were to be 
tested for each certification application. The number of samples tested 
and the test statistic used in the treatment of the data was intended 
to provide a 95% confidence interval of 95% conformance (95% tolerance 
interval) of manufacturers' product to the certification criterion. 
These methods rely on the applicability of the ``normal'' or Gaussian 
distribution for test data. A similar statistical treatment of the test 
data was included in the 1987 NIOSH proposal.
    A number of commenters expressed concern with the use of a NIOSH 
proposed U statistic (based on a 95% tolerance interval for the 95th 
percentile) to determine if the performance of filters submitted by 
manufacturers meet the requirements for requested classification 
(type). Comments concerned the use of the constant 2.22 for the 
calculation of the U statistic, suggesting that this is too strict a 
criterion for manufacturers to meet and implying that 95% tolerance 
intervals based on some lower percentile (e.g., 90th) would be more 
appropriate. Other comments concerned the distribution assumptions 
inherent in the calculation of the U statistic. Commenters expressed 
concern that the assumption that test data represent a sample from a 
Gaussian distribution is incorrect and that the application of 
tolerance interval methods for this data is inappropriate.
    Other commenters questioned NIOSH's justification to ``knowingly'' 
allow the certification of respirators that do not meet the performance 
requirements. They interpreted the statistical criterion as NIOSH 
accepting up to 5% of the distributed respirators to be less than the 
stated class minimum. This analysis of the data would imply that some 
of the distributed certified respirators perform below the inferred 
minimum performance level of its class. The commenters expressed 
concern that this would cause an unacceptably large number of workers 
to have inadequate respirator protection.
    One commenter pointed out that the use of the U statistic was an 
attempt to predict future production variability. This commenter 
further asserted that respirators submitted for certification testing 
do not constitute a random sample of a manufacturer's product. 
Production variability, this commenter continued, is to be controlled 
by the separate quality control program.
    NIOSH concurs with the commenter that the proposed statistical 
approach addressing pre-market production samples is inconsistent with 
determining product quality in a controlled process. NIOSH further 
agrees that the samples submitted for certification testing are not 
random samples. Therefore, the final rule does not include an 
acceptance criterion based upon the statistical treatment of test data.
    A significant portion of the cost attributed to the proposed 
regulations (25 to 30% of the cost, by one estimate) resulted from the 
statistical treatment of data. Manufacturers stated that this cost 
impact would be reduced if a 95% tolerance interval based on a 90 
percentile (i.e., 95% confidence of 90% conformance) were used. 
Manufacturers and others suggested that a pass/fail criterion should be 
offered. Several commenters suggested reducing the number of test 
samples and using a pass/fail criterion.
    A pass/fail criterion is consistent with the current respirator 
acceptance criterion, and is generally accepted as appropriate for a 
certification program with testing of pre-production units. The pass/
fail criterion presents another advantage in that it establishes the 
minimum acceptable performance level consistent with the class 
definition. A member of a 95% class will not be in compliance with the 
certification if it has an efficiency below that level when tested. The 
statistical test criterion could allow some individual units to have 
performance test measurements below 95% but still meet certification 
requirements.
    Based on these comments, NIOSH has reconsidered the use of the 
tolerance interval approach for the analysis of respirator performance 
data. NIOSH agrees that the application of the tolerance interval 
approach is inconsistent with type approval and recognizes that 
respirators submitted for certification do not constitute a random 
sample of a manufacturer's product. Consequently, the final rule has 
been modified to test 20 respirators for laboratory performance, with 
certification if all 20 units meet the specifications.
    The proposal specified both sodium chloride (NaCl) as the solid 
test aerosol and dioctyl phthalate (DOP) as the liquid test aerosol. 
Although DOP is a suspected carcinogen, the set up of the test 
instruments precludes laboratory personnel exposure to the aerosol. 
Sodium chloride does not pose a suspected health hazard. Dioctyl 
phthalate is the most severe liquid, or degrading test aerosol known. 
It has been used for decades as the test aerosol for certification of 
the best (HEPA) part 11 filters. Sodium chloride is a solid test 
aerosol that provides some degrading characteristics. Sodium chloride 
has also been used for years as the solid test agent in the European 
(CEN) certification standards.
    No comments were received against the use of NaCl as the solid test 
aerosol for non-powered respirators. One commenter, a former employee 
of the Department of Defense, questioned its use because the military 
does not use it in their mask testing. Another commenter, accepting the 
use of NaCl, stated that part 84 should allow equivalent test aerosols 
as well. The only negative comments received to the NaCl test aerosol 
were due to the difficulties associated with the testing of powered 
air-purifying respirators (PAPRs). The requirements for PAPRs was 
discussed previously in V. Discussion of Final Rule, B. Powered Air-
Purifying Particulate Respirators.
    Commenters interested in the use of certified respirators for 
protection against TB suggested the use of biological agents 
(bioaerosols) for the certification testing. It is not necessary to 
subject filter respirators to a bioaerosol as a condition of 
certification. By using test aerosols of the most penetrating size 
range, the efficiency-level determination of the certification testing 
will be the lowest obtainable for any size aerosol. Therefore, the 
efficiency level against [[Page 30348]] any bioaerosol for any 
certified respirator will meet or exceed the certified efficiency 
level.
    Comments concerning the choice of liquid test aerosols were varied. 
Several different test agents were suggested including paraffin oil, 
Emery 3004, and hydrofluoric acid. Paraffin oil was suggested because 
it is consistent with the European (CEN) standards. The U.S. military 
has adopted Emery 3004 as a DOP replacement in instantaneous testing of 
filter efficiency. A commenter suggested that because hydrofluoric acid 
aerosol is common in many industries, it would be a more realistic test 
agent.
    Each of the suggested alternative liquid aerosols would provide 
essentially the same initial or lightly loaded filter efficiency 
levels. The initial efficiency level of a filter is defined primarily 
by the particle size of the aerosol, not its degrading ability. The CEN 
standards use paraffin oil as the liquid test aerosol, but the filters 
are not loaded to a significant level. Emery 3004 has been adopted as a 
replacement for DOP by the military in initial efficiency testing as 
performed for the part 11 HEPA filters. Unlike DOP, none of the 
recommended alternative test aerosols provide severe degrading effects 
of the filters. This severity is an integral part of the part 84 
testing, and addressing the uncertainties of the effects of actual 
workplace aerosols.
    In considering these options, NIOSH is aware that no single test 
agent is used by every prominent standard-setting agency or 
organization. The CEN standard uses NaCl as a solid test aerosol. The 
current draft for revising the ANSI Z88.8 standard proposes NaCl and 
DOP as the test aerosols. No choice of test aerosol would provide 
consistency with all other standards, as sought by commenters. A 
fundamental purpose of the new testing standards is to assure that at 
least one class of filters is highly resistant to degradation by 
workplace aerosols. The DOP aerosol was selected for this purpose 
specifically because of its severe effect on filter efficiency level. 
The proposed alternatives demonstrate less severe effects on the filter 
media; therefore, they have been considered inappropriate for the 
evaluation intended by NIOSH.
    The generation method of dioctyl phthalate aerosol was a concern to 
many commenters. Commenters questioned the particle size distribution 
for this test aerosol specified in the proposal being greater than that 
specified in the existing part 11 requirements. Commenters also 
questioned differences in test results based on the use of thermally 
generated (hot) or cold-nebulized DOP aerosol. Although the proposal 
did not specify any aerosol generation technique to be used for DOP 
testing, much of NIOSH's research used as a basis for the proposal was 
performed with cold-nebulized DOP and NIOSH testing has demonstrated 
that correlation in results obtained between the two aerosol generation 
techniques is possible. Some commenters believed that the DOP aerosol 
generation method must be specified to ensure reproducible test 
results. These commenters used data from Industrial Safety Equipment 
Association-sponsored ``round robin'' testing of mechanical and 
electrostatic filter material. Complete data and specifics of the round 
robin testing were not provided to NIOSH. These tests were conducted 
among the majority of the air-purifying respirator manufacturers that 
are ISEA members. The test results indicated excellent correlation 
between the two aerosol generation methods for efficiency of 
standardized mechanical filter media. For standardized electrostatic 
media, a divergence in efficiency with increased filter loading was 
reported between the two aerosol generation methods. These commenters 
also reported that both the initial and stabilized efficiencies of the 
electrostatic media correlated well between the two aerosol generation 
methods. The divergence reported appears to be a different degradation 
rate between the two aerosols.
    Moreover, several of the participants provided some additional 
insights into the circumstances of the testing. A significant portion 
of the manufacturers had recently acquired the cold-nebulized test 
instruments. The reproducibility problems reported, they admitted, 
could have resulted from operator inexperience. One of the participants 
with extensive experience with both aerosol generation methods related 
some of the experience gained by that manufacturer. Excellent 
correlation is maintained between this commenter's numerous cold-
nebulized DOP instruments in use world-wide. Also, the commenter 
reported having encountered no reproducibility problems between 
thermally-generated and cold-nebulized instruments in testing 
electrostatic media when new DOP is used.
    In NIOSH testing, some tests have provided good correlation of 
results between the two aerosol generation methods, while others have 
not. DOP changes chemically as it ages, becoming less pure. The 
thermal-generation method induces a similar chemical change, simulating 
accelerated aging of the DOP. Recent NIOSH testing indicates that the 
chemically-changed DOP may cause the test instruments to fluctuate from 
the stated testing parameters. If monitored closely, and kept within 
the specified parameters, equivalent results are obtained with either 
aerosol generation method. Therefore, to accommodate these concerns, 
the final rule specifies a test using a neat cold-nebulized DOP test, 
or equivalent test. Allowing equivalent test methods permits the use of 
tests that respirator manufacturers may have already developed. As part 
of the established certification process, NIOSH evaluates the test 
results submitted by the applicant by comparing them to the results of 
NIOSH testing. Any test method yielding results equivalent to the NIOSH 
testing will be acceptable.
    To further address the testing reproducibility concerns expressed 
by commenters, NIOSH is initiating a program whereby a standard 
mechanical and electrostatic filter media sample will be made available 
upon request for applicant correlation testing. NIOSH will run 
characterization tests on these standardized media and send a data 
sheet showing the test results with the samples. NIOSH has 
traditionally conducted correlation testing for applicants requesting 
such testing to document the agreement of their test instruments and 
procedures and those of NIOSH. This new procedure will continue the 
service provided to the applicants of assuring that the results they 
obtain on their instruments and with their procedures provide results 
comparable with NIOSH's certification tests. This new process will 
reduce the NIOSH resource requirements for corroborating the test 
results of the large number of applicants that NIOSH anticipates will 
be requesting this service and expedite the correlation process.
    Several comments were received on the humidity preconditioning 
requirement for filters. One commenter stated that the proposed 
preconditioning time (24 hours) was inadequate to have much of an 
effect on the performance of electrostatic filter media. The commenter 
suggested a thirty-day preconditioning period. Information provided 
regarding the ISEA round-robin testing stated that the effects of the 
preconditioning were insignificant when testing with the DOP aerosol. 
This assessment agrees with NIOSH testing experience. The other 
commenters had concerns that the proposal did not provide: detail 
regarding uniform preconditioning, the size of the container, the 
allowable time after conditioning at which filter media must be placed 
within the container and [[Page 30349]] the allowable time for the 
filter to remain within the container until tested.
    The final rule has been modified to require only N-series filters 
be taken out of their packaging and humidity preconditioned prior to 
filter efficiency level testing at 85<plus-minus>5 percent relative 
humidity at 38<plus-minus>2.5  deg.C for 25<plus-minus>1 hours. The 
final rule states that following the preconditioning, the filters shall 
be sealed in a gas-tight container and tested within 10 hours. R- and 
P-series filters do not have to be preconditioned because they are 
tested against DOP which is much more severe than humidity in regard to 
reducing filter efficiency. The preconditioning requirement is retained 
for the N-series filters to address the effect of humidity on the 
filter's efficiency because the sodium chloride aerosol is less severe 
than DOP in reducing filter efficiency. The 10-hour limitation on 
storage of the filters before efficiency testing will eliminate the 
variability concerns.
    The final rule has been modified to specify a scanning mobility 
particle sizer (SMPS) or equivalent, as recommended by commenters, to 
be consistent with the latest technology. One commenter suggested a 
flame photometer be allowed for measurement of sodium chloride. The 
same commenter also stated that other sizing devices such as the 
Tyndall Owl have been used for years and should be an acceptable 
measuring instrument. NIOSH is aware that other instrumentation can 
provide sizing information that can equate to the values specified in 
the rule. In specifying the particle size, it is important to identify 
the technology used in its determination. The differential mobility 
particle sizer (DMPS) was specified in the proposed rule because this 
is the technology traditionally used by NIOSH to determine the particle 
sizes of this test. The use of these other instruments is acceptable 
and all other such equipment does not have to be specified in the final 
rule. To make size verification measurements manufacturers may use any 
particle sizing instrument that provides particle sizing information 
consistent with an SPMS.

Subpart L--Chemical Cartridge Respirators

Section 84.203  Breathing Resistance Tests; Minimum Requirements

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

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

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

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

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

Derivation Table

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

                            Derivation Table                            
------------------------------------------------------------------------
            New section                          Old section            
------------------------------------------------------------------------
42 CFR                               30 CFR                             
  84.1.............................    11.1                             
  84.2.............................    11.3                             
  84.3.............................    11.4                             
  84.4.............................    New.                             
  84.10............................    11.10                            
  84.11............................    11.11                            
  84.12............................    11.12                            
  84.20............................    11.20                            
  84.21............................    11.21                            
  84.22............................    11.22                            
  84.30............................    11.30                            
  84.31............................    11.31                            
  84.32............................    11.32                            
  84.33............................    11.33                            
  84.34............................    11.34                            
  84.35............................    11.35                            
  84.36............................    11.36                            
  84.40............................    11.40                            
  84.41............................    11.41                            
  84.42............................    11.42                            
  84.43............................    11.43                            
  84.50............................    11.50                            
  84.51............................    11.51                            
  84.52............................    11.52                            
  84.53............................    11.53                            
  84.60............................    11.60                            
  84.61............................    11.61                            
  84.62............................    11.62                            
  84.63............................    11.63                            
  84.64............................    11.64                            
  84.65............................    11.65                            
  84.66............................    11.66                            
  84.70............................    11.70                            
  84.71............................    11.71                            
  84.72............................    11.72                            
  84.73............................    11.73                            
  84.74............................    11.74                            
  84.75............................    11.75                            
  84.76............................    11.76                            
  84.77............................    11.77                            
  84.78............................    11.78                            
  84.79............................    11.79                            
  84.80............................    11.79-1                          
  84.81............................    11.80                            
  84.82............................    11.81                            
  84.83............................    11.82                            
  84.84............................    11.83                            
  84.85............................    11.84                            
  84.86............................    11.85-1                          
  84.87............................    11.85-2                          
  84.88............................    11.85-3                          
  84.89............................    11.85-4                          
  84.90............................    11.85-5                          
  84.91............................    11.85-6                          
  84.92............................    11.85-7                          
  84.93............................    11.85-8                          
  84.94............................    11.85-9                          
  84.95............................    11.85-10                         
  84.96............................    11.85-11                         
  84.97............................    11.85-12                         
  84.98............................    11.85-13                         
  84.99............................    11.85-14                         
  84.100...........................    11.85-15                         
  84.101...........................    11.85-16                         
  84.102...........................    11.85-17                         
  84.103...........................    11.85-18                         
  84.104...........................    11.85-19                         
  84.110...........................    11.90                            
  84.111...........................    11.91                            
  84.112...........................    11.92                            
  84.113...........................    11.93                            
  84.114...........................    11.94                            
  84.115...........................    11.95                            
  84.116...........................    11.96                            
  84.117...........................    11.97                            
  84.118...........................    11.98                            
  84.119...........................    11.99                            
  84.120...........................    11.100                           
  84.121...........................    11.101                           
  84.122...........................    11.102-1                         
  84.123...........................    11.102-2                         
  84.124...........................    11.102-3                         
  84.125...........................    11.102-4                         
  84.126...........................    11.102-5                         
  84.130...........................    11.110                           
  84.131...........................    11.111                           
  84.132...........................    11.112                           
  84.133...........................    11.113                           
  84.134...........................    11.114                           
  84.135...........................    11.115                           
  84.136...........................    11.116                           
  84.137...........................    11.117                           
  84.138...........................    11.118                           
[[Page 30350]]
                                                                        
  84.139...........................    11.119                           
  84.140...........................    11.120                           
  84.141...........................    11.121                           
  84.142...........................    11.122                           
  84.143...........................    11.123                           
  84.144...........................    11.124-1                         
  84.145...........................    11.124-2                         
  84.146...........................    11.124-3                         
  84.147...........................    11.124-4                         
  84.148...........................    11.124-5                         
  84.149...........................    11.124-6                         
  84.150...........................    11.124-7                         
  84.151...........................    11.124-8                         
  84.152...........................    11.124-9                         
  84.153...........................    11.124-10                        
  84.154...........................    11.124-11                        
  84.155...........................    11.124-12                        
  84.156...........................    11.124-13                        
  84.157...........................    11.124-14                        
  84.158...........................    11.124-15                        
  84.159...........................    11.124-16                        
  84.160...........................    11.124-17                        
  84.161...........................    11.124-18                        
  84.162...........................    11.124-19                        
  84.163...........................    11.124-20                        
  84.170...........................    11.130                           
  84.171...........................    11.131                           
  84.172...........................    11.132                           
  84.173...........................    11.133                           
  84.174...........................    11.134                           
  84.175...........................    11.135                           
  84.176...........................    11.136                           
  84.177...........................    11.137                           
  84.178...........................    11.138                           
  84.179...........................    New.                             
  84.180...........................    11.140-9                         
  84.181...........................    New.                             
  84.182...........................    11.140-10                        
  84.190...........................    11.150                           
  84.191...........................    11.151                           
  84.192...........................    11.152                           
  84.193...........................    11.153                           
  84.194...........................    11.154                           
  84.195...........................    11.155                           
  84.196...........................    11.156                           
  84.197...........................    11.157                           
  84.198...........................    11.158                           
  84.199...........................    11.158-1                         
  84.200...........................    11.159                           
  84.201...........................    11.160                           
  84.202...........................    11.161                           
  84.203...........................    11.162-1                         
  84.204...........................    11.162-2                         
  84.205...........................    11.162-3                         
  84.206...........................    11.162-7                         
  84.207...........................    11.162-8                         
  84.250...........................    11.200                           
  84.251...........................    11.201                           
  84.252...........................    11.202                           
  84.253...........................    11.203                           
  84.254...........................    11.204                           
  84.255...........................    11.205                           
  84.256...........................    11.206                           
  84.257...........................    11.207                           
  84.258...........................    11.208                           
  84.1100..........................    New.                             
  84.1101..........................    11.3                             
  84.1102..........................    11.20                            
  84.1103..........................    11.33                            
  84.1130..........................    11.102-4, 11.130, 11.170         
  84.1131..........................    11.91, 11.131, 11.171            
  84.1132..........................    11.95, 11.132, 11.175            
  84.1133..........................    11.96, 11.133, 11.176            
  84.1134..........................    11.97, 11.134, 11.177            
  84.1135..........................    11.98, 11.135, 11.178            
  84.1136..........................    11.99, 11.136, 11.179            
  84.1137..........................    11.100, 11.137, 11.180           
  84.1138..........................    11.101, 11.138, 11.181           
  84.1139..........................    11.139, 11.182                   
  84.1140..........................    11.140                           
  84.1141..........................    11.140-1                         
  84.1142..........................    11.140-2                         
  84.1143..........................    11.140-3                         
  84.1144..........................    11.140-4                         
  84.1145..........................    11.140-5                         
  84.1146..........................    11.140-6                         
  84.1147..........................    11.140-7                         
  84.1148..........................    11.140-8                         
  84.1149..........................    11.140-9                         
  84.1150..........................    11.140-10                        
  84.1151..........................    11.140-11                        
  84.1152..........................    11.140-12                        
  84.1153..........................    11.102-4                         
  84.1154..........................    11.172, 11.173                   
  84.1155..........................    11.174                           
  84.1156..........................    11.183, 11.183-1, 11.183-3,      
                                      11.183-4, 11.183-5, 11.183-6,     
                                      11.183-7                          
  84.1157..........................    11.162, 11.162-1, 11.162-4,      
                                      11.162-5, 11.162-6, 11.162-8      
  84.1158..........................    11.162-7                         
------------------------------------------------------------------------

Distribution Table

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

                           Distribution Table                           
------------------------------------------------------------------------
            Old section                          New section            
------------------------------------------------------------------------
30 CFR                               42 CFR                             
  11.1.............................    84.1                             
  11.2.............................    Removed.                         
  11.2-1...........................    Removed.                         
  11.3.............................    84.2, 84.1101                    
  11.4.............................    84.3                             
  11.10............................    84.10                            
  11.11............................    84.11                            
  11.12............................    84.12                            
  11.20............................    84.20, 84.1102                   
  11.21............................    84.21                            
  11.22............................    84.22                            
  11.30............................    84.30                            
  11.31............................    84.31                            
  11.32............................    84.32                            
  11.33............................    84.33, 84.1103                   
  11.34............................    84.34                            
  11.35............................    84.35                            
  11.36............................    84.36                            
  11.40............................    84.40                            
  11.41............................    84.41                            
  11.42............................    84.42                            
  11.43............................    84.43                            
  11.50............................    84.50                            
  11.51............................    84.51                            
  11.52............................    84.52                            
  11.53............................    84.53                            
  11.60............................    84.60                            
  11.61............................    84.61                            
  11.62............................    84.62                            
  11.63............................    84.63                            
  11.64............................    84.64                            
  11.65............................    84.65                            
  11.66............................    84.66                            
  11.70............................    84.70                            
  11.71............................    84.71                            
  11.72............................    84.72                            
  11.73............................    84.73                            
  11.74............................    84.74                            
  11.75............................    84.75                            
  11.76............................    84.76                            
  11.77............................    84.77                            
  11.78............................    84.78                            
  11.79............................    84.79                            
  11.79-1..........................    84.80                            
  11.80............................    84.81                            
  11.81............................    84.82                            
  11.82............................    84.83                            
  11.83............................    84.84                            
  11.84............................    84.85                            
  11.85............................    Removed.                         
  11.85-1..........................    84.86                            
  11.85-2..........................    84.87                            
  11.85-3..........................    84.88                            
  11.85-4..........................    84.89                            
  11.85-5..........................    84.90                            
  11.85-6..........................    84.91                            
  11.85-7..........................    84.92                            
  11.85-8..........................    84.93                            
  11.85-9..........................    84.94                            
  11.85-10.........................    84.95                            
  11.85-11.........................    84.96                            
  11.85-12.........................    84.97                            
  11.85-13.........................    84.98                            
  11.85-14.........................    84.99                            
  11.85-15.........................    84.100                           
  11.85-16.........................    84.101                           
  11.85-17.........................    84.102                           
  11.85-18.........................    84.103                           
  11.85-19.........................    84.104                           
  11.90............................    84.110                           
  11.91............................    84.111, 84.1131                  
  11.92............................    84.112                           
  11.93............................    84.113                           
  11.94............................    84.114                           
  11.95............................    84.115, 84.1132                  
  11.96............................    84.116, 84.1133                  
  11.97............................    84.117, 84.1134                  
  11.98............................    84.118, 84.1135                  
  11.99............................    84.119, 84.1136                  
  11.100...........................    84.120, 84.1137                  
  11.101...........................    84.121, 84.1138                  
  11.102...........................    Removed.                         
  11.102-1.........................    84.122                           
  11.102-2.........................    84.123                           
  11.102-3.........................    84.124                           
  11.102-4.........................    84.125, 84.1130, 84.1153         
  11.102-5.........................    84.126                           
[[Page 30351]]
                                                                        
  11.110...........................    84.130                           
  11.111...........................    84.131                           
  11.112...........................    84.132                           
  11.113...........................    84.133                           
  11.114...........................    84.134                           
  11.115...........................    84.135                           
  11.116...........................    84.136                           
  11.117...........................    84.137                           
  11.118...........................    84.138                           
  11.119...........................    84.139                           
  11.120...........................    84.140                           
  11.121...........................    84.141                           
  11.122...........................    84.142                           
  11.123...........................    84.143                           
  11.124...........................    Removed.                         
  11.124-1.........................    84.144                           
  11.124-2.........................    84.145                           
  11.124-3.........................    84.146                           
  11.124-4.........................    84.147                           
  11.124-5.........................    84.148                           
  11.124-6.........................    84.149                           
  11.124-7.........................    84.150                           
  11.124-8.........................    84.151                           
  11.124-9.........................    84.152                           
  11.124-10........................    84.153                           
  11.124-11........................    84.154                           
  11.124-12........................    84.155                           
  11.124-13........................    84.156                           
  11.124-14........................    84.157                           
  11.124-15........................    84.158                           
  11.124-16........................    84.159                           
  11.124-17........................    84.160                           
  11.124-18........................    84.161                           
  11.124-19........................    84.162                           
  11.124-20........................    84.163                           
  11.124-21........................    Removed.                         
  11.124-22........................    Removed.                         
  11.124-23........................    Removed.                         
  11.124-24........................    Removed.                         
  11.130...........................    84.170, 84.1130                  
  11.131...........................    84.171, 84.1131                  
  11.132...........................    84.172, 84.1132                  
  11.133...........................    84.173, 84.1133                  
  11.134...........................    84.174, 84.1134                  
  11.135...........................    84.175, 84.1135                  
  11.136...........................    84.176, 84.1136                  
  11.137...........................    84.177, 84.1137                  
  11.138...........................    84.178, 84.1138                  
  11.139...........................    84.1139                          
  11.140...........................    84.1140                          
  11.140-1.........................    84.1141                          
  11.140-2.........................    84.1142                          
  11.140-3.........................    84.1143                          
  11.140-4.........................    84.1144                          
  11.140-5.........................    84.1145                          
  11.140-6.........................    84.1146                          
  11.140-7.........................    84.1147                          
  11.140-8.........................    84.1148                          
  11.140-9.........................    84.180, 84.1149                  
  11.140-10........................    84.182, 84.1150                  
  11.140-11........................    84.1151                          
  11.140-12........................    84.1152                          
  11.150...........................    84.190                           
  11.151...........................    84.191                           
  11.152...........................    84.192                           
  11.153...........................    84.193                           
  11.154...........................    84.194                           
  11.155...........................    84.195                           
  11.156...........................    84.196                           
  11.157...........................    84.197                           
  11.158...........................    84.198                           
  11.158-1.........................    84.199                           
  11.159...........................    84.200                           
  11.160...........................    84.201                           
  11.161...........................    84.202                           
  11.162...........................    84.1157                          
  11.162-1.........................    84.203, 84.1157                  
  11.162-2.........................    84.204                           
  11.162-3.........................    84.205                           
  11.162-4.........................    84.1157                          
  11.162-5.........................    84.1157                          
  11.162-6.........................    84.1157                          
  11.162-7.........................    84.206, 84.1158                  
  11.162-8.........................    84.207, 84.1157                  
  11.170...........................    84.1130                          
  11.171...........................    84.1131                          
  11.172...........................    84.1154                          
  11.173...........................    84.1154                          
  11.174...........................    84.1155                          
  11.175...........................    84.1132                          
  11.176...........................    84.1133                          
  11.177...........................    84.1134                          
  11.178...........................    84.1135                          
  11.179...........................    84.1136                          
  11.180...........................    84.1137                          
  11.181...........................    84.1138                          
  11.182...........................    84.1139                          
  11.183...........................    84.1156                          
  11.183-1.........................    84.1156                          
  11.183-2.........................    Removed.                         
  11.183-3.........................    84.1156                          
  11.183-4.........................    84.1156                          
  11.183-5.........................    84.1156                          
  11.183-6.........................    84.1156                          
  11.183-7.........................    84.1156                          
  11.200...........................    84.250                           
  11.201...........................    84.251                           
  11.202...........................    84.252                           
  11.203...........................    84.253                           
  11.204...........................    84.254                           
  11.205...........................    84.255                           
  11.206...........................    84.256                           
  11.207...........................    84.257                           
  11.208...........................    84.258                           
------------------------------------------------------------------------

VII. Executive Order 12866 and Regulatory Flexibility Act

    Section 1 of Executive Order 12866 requires that before 
promulgating a new regulation, an agency must weigh many competing 
factors. In particular, the agency must assess the need for the 
regulation, identify and assess alternatives, determine whether the 
regulation is designed to achieve the agency's objectives in the most 
cost-effective manner, and, to the extent feasible, use performance 
standards. In addition, Section 5 of the Order requires an assessment 
of the burden imposed by existing regulations, to identify those that 
have become unjustified or unnecessary as a result of changed 
circumstances. The Regulatory Flexibility Act (the Act) also requires 
that the agency periodically review existing regulations and consider 
reforming those that burden small entities, taking into account the 
degree to which technology or other factors have changed in the area 
affected by the rule. NIOSH is promulgating these regulatory changes in 
compliance with both sections of the Executive Order and the Act.
    Dose-response data are inadequate to permit a quantitative 
description of the risks that would be faced by American workers if 
respirators were not used. Neither are there dose-response data that 
can support a quantitative description of the risk reduction that will 
be achieved by the revised filter performance standards in 42 CFR part 
84. Employers frequently lack the economic means or the technical 
expertise to make detailed workplace hazard assessments. For the great 
majority of occupational settings, environmental data on the airborne 
concentrations of toxic materials are completely lacking. When exposure 
data are available, they tend to be limited at best. Consequently, it 
is difficult to establish quantitative exposure-response relationships. 
Most often, occupational exposure data demonstrate the association 
between exposure and response, but do not support a precise exposure-
response curve. Extrapolation from exposure to dose is subject to even 
greater uncertainty. The variability in exposure between and within 
workplaces, exposures over long working lifetimes, possibly 
inconsistent or improper use of respiratory protection, and undetected 
episodes of substandard respirator performance, among other factors, 
all make it very difficult to determine what a worker's dose may be 
even if there are measured exposure levels.
    Employers, both large and small, rely upon respirators to protect 
their employees from airborne toxic contaminants. The preferred and 
most effective means of protecting workers is to prevent hazards 
entering their breathing zone in the first place, but it is not 
technologically or economically feasible in all instances to reduce 
airborne concentrations to safe levels. In those workplaces, 
respiratory protection is required to minimize workers' risks of acute 
and chronic health effects. Although the incremental risk reduction 
associated with this rulemaking cannot be quantified, it is evident 
that increased filtering efficiency and enhanced filter reliability 
must increase the margin of safety for respirator users.
    As the last, and occasionally the only, defense against some acute 
and chronic health hazards at work it is important that respirators be 
reliable and that they perform in the manner and to the extent the user 
and employer expect. If respirators fail to perform as expected, the 
user will be at greatly increased risk of suffering serious, sometimes 
fatal, [[Page 30352]] occupational disease or injury. In most 
circumstances the respirator user has no way of knowing if respirator 
performance is substandard. Except for the most acute responses to 
substandard respirator performance, it is not possible to attribute 
health effects to a failure of respiratory protection. Most of the 
serious occupational diseases have long latency periods, so respirator 
users typically would not know if they used an inferior device. Even 
the relationship to workplace exposures can be obscured because of the 
presumption that respirators provide effective protection.
    Respriator purchasers and users expect and deserve to be able to 
select respirators with complete confidence that they will perform with 
a specific efficiency for a specific purpose. They rely on the NIOSH, 
formerly MSHA/NIOSH, performance standards and certification program to 
assure them that they can have that confidence.
    These new particulate filter efficiency tests are needed to reduce 
potential health risks that may result from leakage of small 
particulates through some filters certified under the current 
regulations (30 CFR part 11). For over a decade the filter penetration 
tests contained in 30 CFR part 11 have been known to be deficient. 
Leakage of small aerosols has been recognized as a problem that could 
be corrected only by revising that regulation.
    The magnitude of the filter leakage problem came into sharper focus 
in the early 1990's when NIOSH and other researchers used modern 
methods not available under the provisions of part 11 to measure 
performance over a range of particle sizes. For certain models, 
leakages higher than 50% were found. Not all respirator models exhibit 
this high level of leakage, but 30 CFR part 11 testing does not 
distinguish adequate from inadequate filters.
    The respirator community acknowledges filter leakage to be a 
problem. The American National Standards Institute (ANSI) Z88.2-1992 
national standard, for example, states that 2 of the 3 types of 
particulate respirators certified under 30 CFR part 11 should be used 
only when the workplace particulate contaminant is know to have a mass 
median aerodynamic diameter (MMAD) greater that 2 micrometer.
    Compliance with aerosol size limitations such as those of the ANSI 
Z88.2 would represent a major technologic and economic burden for 
respirator users. Those burdens are great even for the largest 
employers and exceed the capacity of smaller employers. Adequate worker 
protection with DM and DFM respirators certified under 30 CFR part 11 
can be assured only if employers conduct sophisticated and expensive 
measurements of the size distribution of the aerosol in each workplace. 
This is simply too expensive for the great majority of respirator 
users, who may elect to use DM or DFM respirators without evaluating 
aerosols in their workplaces, thereby placing their workers at 
increased risk of occupational disease or disability. The only 
alternative at present is for those employers to provide costly high 
efficiency (HEPA) filters. The difficult and costly aerosol size 
measurements are not needed when HEPA filters are used because they are 
tested with the most penetrating size of aerosol. HEPA filters are 
therefore known to be effective against any aerosol regardless of size.
    The new 42 CFR part 84 filter efficiency tests use only the most 
penetrating aerosol size, so all filters certified under these new 
procedures will be effective against any size aerosol. This new rule 
thereby corrects an acknowledged deficiency in existing filter 
efficiency tests, removes from the workplace respirators that fail to 
deliver the expected degree of worker protection, relieves employers of 
the need to perform costly and difficult measurements of aerosol size 
distribution, and provides alternatives to the expensive HEPA filters 
in workplaces where the aerosol size is either unknown or is known to 
be small.
    This new rule continues to limit, as does the current 30 CFR part 
11, the breathing resistance (inhalation and exhalation resistance) of 
the respirator. Breathing resistance is significant to respirator 
wearers in three ways. First, higher breathing resistance increases 
leakage at the face seal of the respirator. Face seal leakage is 
directly proportional to breathing resistance, other factors being 
equal. Second, respirators with lower breathing resistance are more 
comfortable and more acceptable to wearers. If a respirator is 
uncomfortable to wear, workers are less inclined to use their 
respirator as often as they should. Third, high breathing resistance 
can be an unacceptable physiological burden on some workers. For a 
worker with impaired pulmonary or cardiovascular function, high 
breathing resistance may make respirator use impossible. In this rule, 
NIOSH has increased the allowable inhalation and exhalation resistance 
in consideration of minimizing economic impact, but NIOSH has 
maintained the breathing resistance at a level that still will minimize 
adverse impacts on the respirator user.
    E.O. 12866 further requires the agency to determine whether the 
proposed rule is ``economically significant'' (e.g., it does not have 
an annual effect on the economy of $100 million). NIOSH generally 
prepares a regulatory flexibility analysis, in accordance with the Act, 
if the rule is expected to have a significant impact on a substantial 
number of small entities. NIOSH does not believe that this final rule 
will have an annual impact on the economy of $100 million, nor does 
NIOSH believe that the rule will have a significant impact on a 
substantial number of small firms.
    This regulatory change affects only particulate respirators. A 
total of 56 manufacturers hold respirator approvals, and 33 of these 
hold approvals for particulate respirators. Based on inquiries 
received, NIOSH believes that several additional manufacturers are 
planning to submit applications for particulate filter products under 
this new regulation.
    Data are not available to define company size, market share, or 
diversity of products for the current approval-holders. Projections of 
impact are based on an understanding of manufacturers dependence on 
existing approved particulate respirators. Of the 33 manufacturers that 
have particulate filer approvals, 24 hold additional approvals for 
devices other than particulate respirators, and nine have only 
particulate filter approvals. One of these manufacturer holds approvals 
for DM, DFM and HEPA respirators, while the remaining eight each hold 
only a single particulate filter approval. Because all existing HEPA 
filters are expected to pass the new certification tests, it appears 
that only eight of 56 respirator manufacturers might be dependent upon 
particulate filter respirators possibly at risk of not passing the new 
certification tests without redesign. At least one of these eight 
manufacturers commented favorably on this proposed rule, indicating 
readiness to meet these new criteria.
    Any manufacturer that cannot meet the new criteria immediately will 
have three years in which to develop new products or face removal from 
the approved respirator market. However, loss of approved respirator 
status does not prohibit sales of the devices as non-approved units. 
The non-approved respirator market appears to be very lucrative, with 
several of the larger manufacturers participating. Non-approved 
respirators are sold in many retail outlets including hardware, auto 
supply, and department stores. Consumers purchase these devices for use 
against nuisance dusts while [[Page 30353]] performing various home and 
hobby-related activities.
    While some current respirator manufacturers may experience negative 
impacts, other manufacturers that are not now approval holders have 
indicated an intention to enter this market. The new rule thus will 
stimulate competition as new technologies are introduced and new 
markets are developed. Furthermore, this rule enhances the ability of 
domestic manufacturers to compete globally, especially in the European 
Community. NIOSH expects to see more new approval holders develop as a 
result of the new rule.
    A high percentage of the respirator manufacturers are large 
corporations or subsidiaries and are international in nature, although 
several employ 100 or fewer persons. NIOSH does not have an estimate of 
the total number employed by the 33 manufacturers of particulate 
respirators. Neither does NIOSH have any indication of how many 
employees are engaged solely in the manufacture of particulate 
respirators. However, the respirator manufacturing industry in general 
is mature and stable. A 1982 survey of the industry performed for NIOSH 
covered 29 firms that were active at that time, the majority of which 
continue to manufacture respirators in 1995. Of these, 12 were 
subsidiaries of larger firms. Median total employment was 375. A large 
portion of these workers were believed to be engaged in activities 
unrelated to particulate respirator manufacturing. Sales figures 
indicated respirator sales ranged from less than 1% to 10-15% of total 
corporate sales.
    NIOSH believes the industry profile remains basically the same it 
was in 1982. That is, respirators do not represent the primary source 
of sales income for any of the manufacturers that will be affected. 
Because respirators represent a low percentage of overall sales, the 
percentage of total employees involved in the manufacture of 
respirators is believed also to be low. Therefore, few employees are 
likely to be severely impacted by the new rule. Indeed, the increased 
competition and opening of markets expected to result from the rule may 
well enhance aggregate employment for both current and new approval 
holders.
    Most employers rely on government standards to determine acceptable 
levels of respirator performance. It would be inefficient and 
unreasonably costly for each of millions of occasional purchasers of 
these inexpensive devices to independently attempt to determine which 
devices operate effectively to filter out submicron toxic particles.
    This rule removes a regulatory impediment to the improved design of 
respirators by substituting a performance standard for an obsolete 
specifications standard. The practical effect of this will be to enable 
firms to substitute a more effective and efficient filter material in 
lower-cost respirators. Respirators already using high efficiency 
filters meeting 30 CFR part 11 requirements will not be affected by 
this proposal. These respirators will not require modification to be 
certified under this final rule, although the certification may not be 
at the new P100 efficiency level. Although the category of performance 
may be reduced from the previous HEPA rating, no design or development 
costs are associated with the certification of these products.
    NIOSH received limited responses to its request for comments and 
data for projected estimates of cost for materials and labor for these 
improved respirators. Several respirator manufacturers referred to a 
survey conducted by their trade association as suggesting that costs of 
this module would exceed $100 million, but specific cost estimates for 
this module were not provided. The trade association reported that 
their estimate was based largely on the surveyed manufacturers' 
projections of procuring new equipment, procuring new materials, plant 
retooling, and the like. The largest manufacturer of respirators did 
not project the same cost impact on its products, even though that 
manufacturer recommended changing the proposed rule to eliminate the 
least costly class of proposed respirators and to increase the severity 
of two testing parameters. Another manufacturer stated that the 
``projected increased user cost for disposables of 42 CFR part 84 would 
be between $440 and $990 million,'' based solely on impacts to that 
manufacturer's products. This manufacturer forecast that prices to end 
users would rise by 1.7- to 2.9-fold or 9- to 16-fold depending on 
filter type.
    Very limited data were submitted in support of any of these 
estimates, but it appears that the large discrepancy between NIOSH and 
industry cost estimates are attributable to 3 principal factors:
    (1) Cost estimates by industry included many capital investmet 
costs rather than recurring annual costs, inclusion of which improperly 
inflated the annual cost projections.
    (2) An erroneous assumption made by the manufacturer projecting the 
greatest cost impact. That manufacturer assumed that the proposed fit 
test would require all disposable respirators to have an elastomeric 
flange. Additional costs attributed to consumer reaction to this 
assumption were:
    (a) expensive reusable elastomeric cartridge respirators replacing 
inexpensive disposable models, and
    (b) costly respirator maintenance and training programs associated 
with reusable respirators.
    Neither NIOSH nor other manufacturers projected either of these as 
a consequence of the fit testing. In any event, the requirement for fit 
testing was eliminated from the final rule. That represents a cost 
saving in itself but this change also renders moot the question of 
elastomeric flanges for disposable respirators.
    (3) Two additional elements of the proposed rule were identified as 
having significant cost impact: statistical evaluation of certification 
test results and limitations on inhalation/exhalation resistance. These 
were changed in the final rule to eliminate the statistical criterion 
and to adopt the inhalation/ exhalation resistance levels requested by 
the manufacturers. As a result and as discussed below under specific 
topics, NIOSH does not believe that this rule will approach the $100 
million threshold. In fact, NIOSH believes that over time 
manufacturers' costs and prices to users will fall.
    Commenters stated that the statistical treatment of test data as 
included in the proposal would ``add greatly to the cost of filters and 
respirators.'' One commenter estimated that the added manufacturing and 
waste costs attributable to this provision would be 25-30% of the costs 
attributable to the proposal. According to the commenters, the 
replacement of the proposed statistical treatment of test data with the 
less stringent statistical treatment proposed by NIOSH in 1987 or a 
pass/fail criterion would remove the added cost implications of the 
proposed rule.
    As discussed previously, NIOSH has replaced the proposed 
requirement for the statistical treatment of test data with the 
recommended pass-fail criterion. Twenty filters are to be tested, 
reduced from 30 to be required under the proposal. This change in the 
final rule, based on technical concerns discussed previously, will 
significantly reduce the cost implications of the final rule from the 
estimated costs of the proposal.
    The fit test requirements proposed under Secs. 84.181 and 84.182 
were identified as another source of a significant portion of the costs 
attributed to the proposed rule. The increased costs resulted from the 
interpretation that the isoamyl acetate testing would necessitate 
elastomeric inner flanges to be added to all certified disposable 
respirators in all categories. [[Page 30354]] This interpretation led 
to two conclusions that increased the cost estimates. The first 
conclusion was that all disposable filter respirators would need to be 
redesigned to include a costly elastomeric facepiece. The estimated 
increased costs of disposable respirators led to the second conclusion 
that the currently inexpensive and widely used disposable particulate 
respirators would be replaced by costly reusable elastomeric cartridge 
masks. This increased use of reusable masks was estimated to increase 
users' costs of respirator maintenance and training programs not 
associated with disposable respirators. The costs associated with the 
use of an isoamyl acetate represented a substantial portion of the 
projected cost impact of the proposed rule.
    As discussed earlier, NIOSH has reconsidered the proposed 
requirement for isoamyl acetate fit-testing of these respirators. Based 
on technical considerations, the isoamyl acetate tests have not been 
included in the final rule. NIOSH anticipates that currently accepted, 
fit-testing procedures will continue to be used to assure a proper 
respirator-to-face seal for each respirator user. Based on prior 
experience with currently certified disposable respirators using these 
procedures, no redesign of the facepiece seal of disposable respirators 
will be required as a result of this final rule. Therefore, the cost 
implications attributed to the isoamyl acetate fit tests are not 
applicable to this final rule.
    It is our understanding that substituting better filter material 
will have negligible effects on the costs of filters, over the long 
run. The material costs may be slightly increased, but are relatively 
small compared to those estimates for statistical evaluation and fit 
testing. The costs associated with these latter two have been greatly 
reduced by the requirements in the final rule.
    The demonstrated level of performance for filters will be 
substantially more effective. Instead of an efficiency rate of 95 
percent for removing particles sized at 1 to 2 micrometers in diameter, 
they will demonstrate the ability to remove particles of less than 1 
micrometer in diameter at a typical efficiency rate of 95 to 99.97 
percent. The importance of this change will vary considerably from 
workplace setting to setting. However, in at least some settings the 
benefits will be considerable.
    For example, the classes of particulate filter respirators 
certified under this rule will meet or exceed the recommendations for 
respiratory protective devices used for M. tuberculosis. Of the 
currently NIOSH-certified respirators, only high-efficiency particulate 
air (HEPA) filters meet or exceed these recommendations. The 
certification to an enhanced performance level will create options for 
the choice of respirators that adhere to the recommendations at reduced 
expense. A disposable (one-time use) HEPA filter respirator generally 
sells for around $7 to $10 and replaceable respirators equipped with 
HEPA filters can cost $20 or more, with replacement filters costing 
about $5 each. Replacement non-HEPA filters cost about $1 to $2 each. 
Disposable non-HEPA filters cost about $1 to $8 each when purchased in 
bulk. Costs for a N95 filter are expected to be less than those of a 
current HEPA filter. Applications of new filter technologies and market 
competition is expected to generally have the impact of reducing the 
cost of the new respirators. At least one commenter has already 
indicated that the 95% efficiency level respirators will be priced not 
exceeding the cost of 30 CFR part 11 disposable DFM respirators, $5 to 
$8 each.
    NIOSH would expect similar effects--both improved health and cost 
avoidance--in many other settings. NIOSH estimates that as many as 
seven million workers use respirators at some time each year. NIOSH 
estimates that employers annually purchase over 110 million disposable 
respirators.
    There are approximately 35 manufacturers of these respiratory 
devices. Most of these already possess or have access to test equipment 
needed to perform the new filter tests. As is currently required under 
30 CFR part 11, NIOSH will continue to require that applicants conduct 
or have conducted examinations, inspections, and tests of respirator 
performance at least equivalent to those set by the respirator 
certification tests. This is to assure that all necessary research and 
development is conducted by the applicant prior to submitting an 
application to the Federal Government for testing of the respirator by 
NIOSH. For those manufacturers that do not currently possess this 
capability, NIOSH estimates that the purchase of this equipment 
represents an investment of approximately $60,000. Amortized over time, 
this would not represent a significant cost for most manufacturers.
    Commenters indicated that the projected costs of new, updated test 
instruments for the filter efficiency testing contributed significantly 
to the costs reported to be attributable to the proposed rule. NIOSH 
agrees that if manufacturers opt to purchase newly developed 
instruments, this represents a significant investment. As discussed 
previously, the filter efficiency tests of this final rule can be 
conducted using the instrumentation previously specified for the 
testing of high efficiency filters under 30 CFR part 11. Therefore, the 
purchase of new test instruments is not required for most 
manufacturers. Further, the purchase of test instruments represents a 
capital investment amortized over time, not an annual recurring cost.
    Filter materials are currently available that can be substituted 
into present filter designs with minimal redesign (if any) to meet the 
performance requirements of the new tests. Some currently NIOSH-
certified respirators have, when tested using the new standards, 
demonstrated acceptable performance. Therefore, little or no cost will 
be needed to develop suitable filtration materials or redesign existing 
devices. However, NIOSH does realize that additional development and 
redesign costs may be incurred to augment the presently available 
products. NIOSH specifically requested relevant data and comments on 
projected costs of redesign of respirators.
    One commenter cited the cost of commercially available filter media 
to meet the proposed standards as dramatically increased over the 
present cost of the existing 30 CFR part 11 disposable dust/mist 
requirements. The cost of present dust/mist media was stated as between 
60 cents and one dollar per square yard, whereas the cost of 
commercially available filter media to meet the proposed 42 CFR part 84 
requirements is between 12 dollars and 17 dollars per square yard, 
depending on the type (A, B, or C), and whether it is for the 
``solids'' or ``liquid/solids'' category. Two other commenters 
indicated the availability of prototype respirators and filters that 
could be marketed for little or no cost increase from existing dust/
fume/mist respirators and filters.
    Several comments were received stating that the combination of 
proposed initial inhalation and exhalation resistance limits and 
efficiency levels might require increasing the surface area of filters. 
It was asserted that an increase in filter surface area to meet these 
requirements would ``increase substantially the raw material and 
manufacturing costs of respirator protection.'' For the technical 
reasons discussed previously, the initial inhalation and exhalation 
resistances have been increased in the final rule to the values 
recommended by these commenters. Adoption of these values will allow 
``latitude to develop filters at [[Page 30355]] a reasonable cost 
without compromising safety or comfort to the user,'' according to the 
comments.
    In summary, NIOSH did not believe the proposed rule change was 
``economically significant'' within the definition of E.O. 12866 based 
on the cost projections attributable to the proposal that were provided 
to NIOSH and those modifications incorporated into the final rule.
    Notwithstanding these general conclusions, there may be some 
manufacturers that will find it financially difficult, or a poor 
investment, to meet the new standards. NIOSH expects such problems to 
result from free market competition rather than the specific standards 
of these final regulations. That is, most knowledgeable employers would 
purchase more cost-effective respirators voluntarily and force major 
changes in the market if the present regulatory barriers were removed.

List of Subjects in 42 CFR Part 84

    Administrative practice and procedure, Incorporation by reference, 
Labeling, Mine safety and health, Occupational safety and health, 
Personal protective equipment, Reporting and recordkeeping 
requirements, Respirators.

    Dated: April 14, 1995.
Philip R. Lee,
Assistant Secretary for Health.

    Dated: April 14, 1995.
Donna E. Shalala,
Secretary.

    For the reasons set out in the preamble, 42 CFR part 84 is added to 
read as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Subpart A--General Provisions

Sec.
84.1  Purpose.
84.2  Definitions.
84.3  Respirators for mine rescue or other emergency use in mines.

Subpart B--Application for Approval

84.10  Application procedures.
84.11  Contents of application.
84.12  Delivery of respirators and components by applicant; 
requirements.

Subpart C--Fees

84.20  Examination, inspection, and testing of complete respirator 
assemblies; fees.
84.21  Examination, inspection, and testing of respirator components 
or subassemblies; fees.
84.22  Unlisted fees; additional fees; payment by applicant prior to 
approval.

Subpart D--Approval and Disapproval

84.30  Certificates of approval; scope of approval.
84.31  Certificates of approval; contents.
84.32  Notice of disapproval.
84.33  Approval labels and markings; approval of contents; use.
84.34  Revocation of certificates of approval.
84.35  Changes or modifications of approved respirators; issuance of 
modification of certificate of approval.
84.36  Delivery of changed or modified approved respirator.

Subpart E--Quality Control

84.40  Quality control plans; filing requirements.
84.41  Quality control plans; contents.
84.42  Proposed quality control plans; approval by the Institute.
84.43  Quality control records; review by the Institute; revocation 
of approval.

Subpart F--Classification of Approved Respirators; Scope of Approval; 
Atmospheric Hazards; Service Time

84.50  Types of respirators to be approved; scope of approval.
84.51  Entry and escape, or escape only; classification.
84.52  Respiratory hazards; classification.
84.53  Service time; classification.

Subpart G--General Construction and Performance Requirements

84.60  Construction and performance requirements; general.
84.61  General construction requirements.
84.62  Component parts; minimum requirements.
84.63  Test requirements; general.
84.64  Pretesting by applicant; approval of test methods.
84.65  Conduct of examinations, inspections, and tests by the 
Institute; assistance by applicant; observers; recorded data; public 
demonstrations.
84.66  Withdrawal of applications; refund of fees.

Subpart H--Self-Contained Breathing Apparatus

84.70  Self-contained breathing apparatus; description.
84.71  Self-contained breathing apparatus; required components.
84.72  Breathing tubes; minimum requirements.
84.73  Harnesses; installation and construction; minimum 
requirements.
84.74  Apparatus containers; minimum requirements.
84.75  Half-mask facepieces, full facepieces, mouthpieces; fit; 
minimum requirements.
84.76  Facepieces; eyepieces; minimum requirements.
84.77  Inhalation and exhalation valves; minimum requirements.
84.78  Head harnesses; minimum requirements.
84.79  Breathing gas; minimum requirements.
84.80  Interchangeability of oxygen and air prohibited.
84.81  Compressed breathing gas and liquefied breathing gas 
containers; minimum requirements.
84.82  Gas pressure gages; minimum requirements.
84.83  Timers; elapsed time indicators; remaining service life 
indicators; minimum requirements.
84.84  Hand-operated valves; minimum requirements.
84.85  Breathing bags; minimum requirements.
84.86  Component parts exposed to oxygen pressures; minimum 
requirements.
84.87  Compressed gas filters; minimum requirements.
84.88  Breathing-bag test.
84.89  Weight requirement.
84.90  Breathing resistance test; inhalation.
84.91  Breathing resistance test; exhalation.
84.92  Exhalation valve leakage test.
84.93  Gas flow test; open circuit apparatus.
84.94  Gas flow test; closed circuit apparatus.
84.95  Service-time test; open circuit apparatus.
84.96  Service-time test; closed circuit apparatus.
84.97  Test for carbon dioxide in inspired gas; open- and closed-
circuit apparatus; maximum allowable limits.
84.98  Tests during low temperature operation.
84.99  Man tests; testing conditions; general requirements.
84.100  Man tests 1, 2, 3, and 4; requirements.
84.101  Man test 5; requirements.
84.102  Man test 6; requirements.
84.103  Man tests; performance requirements.
84.104  Gas tightness test; minimum requirements.

Tables to Subpart H of Part 84

Subpart I--Gas Masks

84.110  Gas masks; description.
84.111  Gas masks; required components.
84.112  Canisters and cartridges in parallel; resistance 
requirements.
84.113  Canisters and cartridges; color and markings; requirements.
84.114  Filters used with canisters and cartridges; location; 
replacement.
84.115  Breathing tubes; minimum requirements.
84.116  Harnesses; installation and construction; minimum 
requirements.
84.117  Gas mask containers; minimum requirements.
84.118  Half-mask facepieces, full facepieces, and mouthpieces; fit; 
minimum requirements.
84.119  Facepieces; eyepieces; minimum requirements.
84.120  Inhalation and exhalation valves; minimum requirements.
84.121  Head harnesses; minimum requirements.
84.122  Breathing resistance test; minimum requirements.
84.123  Exhalation valve leakage test.
84.124  Facepiece tests; minimum requirements. [[Page 30356]] 
84.125  Particulate tests; canisters containing particulate filters; 
minimum requirements.
84.126  Canister bench tests; minimum requirements.

Tables to Subpart I of Part 84

Subpart J--Supplied-Air Respirators

84.130  Supplied-air respirators; description.
84.131  Supplied-air respirators; required components.
84.132  Breathing tubes; minimum requirements.
84.133  Harnesses; installation and construction; minimum 
requirements.
84.134  Respirator containers; minimum requirements.
84.135  Half-mask facepieces, full facepieces, hoods, and helmets; 
fit; minimum requirements.
84.136  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.
84.137  Inhalation and exhalation valves; check valves; minimum 
requirements.
84.138  Head harnesses; minimum requirements.
84.139  Head and neck protection; supplied-air respirators; minimum 
requirements.
84.140  Air velocity and noise levels; hoods and helmets; minimum 
requirements.
84.141  Breathing gas; minimum requirements.
84.142  Air supply source; hand-operated or motor driven air 
blowers; Type A supplied-air respirators; minimum requirements.
84.143  Terminal fittings or chambers; Type B supplied-air 
respirators; minimum requirements.
84.144  Hand-operated blower test; minimum requirements.
84.145  Motor-operated blower test; minimum requirements.
84.146  Method of measuring the power and torque required to operate 
blowers.
84.147  Type B supplied-air respirator; minimum requirements.
84.148  Type C supplied-air respirator, continuous-flow class; 
minimum requirements.
84.149  Type C supplied-air respirator, demand and pressure demand 
class; minimum requirements.
84.150  Air-supply line tests; minimum requirements.
84.151  Harness test; minimum requirements.
84.152  Breathing tube test; minimum requirements.
84.153  Airflow resistance test, Type A and Type AE supplied-air 
respirators; minimum requirements.
84.154  Airflow resistance test; Type B and Type BE supplied-air 
respirators; minimum requirements.
84.155  Airflow resistance test; Type C supplied-air respirator, 
continuous flow class and Type CE supplied-air respirator; minimum 
requirements.
84.156  Airflow resistance test; Type C supplied-air respirator, 
demand class; minimum requirements.
84.157  Airflow resistance test; Type C supplied-air respirator, 
pressure-demand class; minimum requirements.
84.158  Exhalation valve leakage test.
84.159  Man tests for gases and vapors; supplied-air respirators; 
general performance requirements.
84.160  Man tests for gases and vapors; Type A and Type AE 
respirators; test requirements.
84.161  Man tests for gases and vapors; Type B and Type BE 
respirators; test requirements.
84.162  Man test for gases and vapors; Type C respirators, 
continuous-flow class and Type CE supplied-air respirators; test 
requirements.
84.163  Man test for gases and vapors; Type C supplied-air 
respirators, demand and pressure-demand classes; test requirements.

Tables to Subpart J of Part 84

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

84.170  Non-powered air-purifying particulate respirators; 
description.
84.171  Non-powered air-purifying particulate respirators; required 
components.
84.172  Breathing tubes; minimum requirements.
84.173  Harnesses; installation and construction; minimum 
requirements.
84.174  Respirator containers; minimum requirements.
84.175 Half-mask facepieces, full facepieces, hoods, helmets, and 
mouthpieces; fit; minimum requirements.
84.176  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.
84.177  Inhalation and exhalation valves; minimum requirements.
84.178  Head harnesses; minimum requirements.
84.179  Non-powered air-purifying particulate respirators; filter 
identification.
84.180  Airflow resistance tests.
84.181  Non-powered air-purifying particulate filter efficiency 
level determination.
84.182  Exhalation valve leakage test; minimum requirements.

Subpart L--Chemical Cartridge Respirators

84.190  Chemical cartridge respirators; description.
84.191  Chemical cartridge respirators; required components.
84.192  Cartridges in parallel; resistance requirements.
84.193  Cartridges; color and markings; requirements.
84.194  Filters used with chemical cartridges; location; 
replacement.
84.195  Breathing tubes; minimum requirements.
84.196  Harnesses; installation and construction; minimum 
requirements.
84.197  Respirator containers; minimum requirements.
84.198  Half-mask facepieces, full facepieces, mouthpieces, hoods, 
and helmets; fit; minimum requirements.
84.199  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.
84.200  Inhalation and exhalation valves; minimum requirements.
84.201  Head harnesses; minimum requirements.
84.202  Air velocity and noise levels; hoods and helmets; minimum 
requirements.
84.203  Breathing resistance test; minimum requirements.
84.204  Exhalation valve leakage test; minimum requirements.
84.205  Facepiece test; minimum requirements.
84.206  Particulate tests; respirators with filters; minimum 
requirements; general.
84.207  Bench tests; gas and vapor tests; minimum requirements; 
general.

Tables to Subpart L of Part 84

Subpart M--[Reserved]

Subpart N--Special Use Respirators

84.250  Vinyl chloride respirators; description.
84.251  Required components.
84.252  Gas masks; requirements and tests.
84.253  Chemical-cartridge respirators; requirements and tests.
84.254  Powered air-purifying respirators; requirements and tests.
84.255  Requirements for end-of-service-life indicator.
84.256  Quality control requirements.
84.257  Labeling requirements.
84.258  Fees.

Subparts O through JJ [Reserved]

Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray; Powered Air-
Purifying High Efficiency Respirators and Combination Gas Masks

84.1100  Scope and effective dates.
84.1101  Definitions.
84.1102  Examination, inspection and testing of complete respirator 
assemblies; fees.
84.1103  Approval labels and markings; approval of contents; use.
84.1130  Respirators; description.
84.1131  Respirators; required components.
84.1132  Breathing tubes; minimum requirements.
84.1133  Harnesses; installation and construction; minimum 
requirements.
84.1134  Respirator containers; minimum requirements.
84.1135  Half-mask facepieces, full facepieces, hoods, helmets, and 
mouthpieces; fit; minimum requirements.
84.1136  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.
84.1137  Inhalation and exhalation valves; minimum requirements.
84.1138  Head harnesses; minimum requirements.
84.1139  Air velocity and noise levels; hoods and helmets; minimum 
requirements.
84.1140  Dust, fume, and mist respirators; performance requirements; 
general.
84.1141  Isoamyl acetate tightness test; dust, fume, and mist 
respirators designed for respiratory protection against fumes of 
various metals having an air contamination level not less than 0.05 
milligram per cubic meter; minimum requirements. [[Page 30357]] 
84.1142  Isoamyl acetate tightness test; respirators designed for 
respiratory protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter, or 
against radionuclides; minimum requirements.
84.1143  Dust, fume, and mist air-purifying filter tests; 
performance requirements; general.
84.1144  Silica dust test for dust, fume, and mist respirators; 
single-use or reusable filters; minimum requirements.
84.1145  Silica dust test; non-powered single-use dust respirators; 
minimum requirements.
84.1146  Lead fume test for dust, fume, and mist respirators; 
minimum requirements.
84.1147  Silica mist test for dust, fume, and mist respirators; 
minimum requirements.
84.1148  Tests for respirators designed for respiratory protection 
against more than one type of dispersoid; minimum requirements.
84.1149  Airflow resistance tests; all dust, fume, and mist 
respirators; minimum requirements.
84.1150  Exhalation valve leakage test; minimum requirements.
84.1151  DOP filter test; respirators designed as respiratory 
protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter and 
against radionuclides; minimum requirements.
84.1152  Silica dust loading test; respirators designed as 
protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter and 
against radionuclides; minimum requirements.
84.1153  Dust, fume, mist, and smoke tests; canister bench tests; 
gas mask canisters containing filters; minimum requirements.
84.1154  Canister and cartridge requirements.
84.1155  Filters used with canisters and cartridges; location; 
replacement.
84.1156  Pesticide respirators; performance requirements; general.
84.1157  Chemical cartridge respirators with particulate filters; 
performance requirements; general.
84.1158  Dust, fume, and mist tests; respirators with filters; 
minimum requirements; general.

Tables to Subpart KK of Part 84

    Authority: 29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C. 3, 
5, 7, 811, 842(h), 844.

Subpart A--General Provisions


Sec. 84.1  Purpose.

    The purpose of the regulations contained in this part 84 is:
    (a) To establish procedures and prescribe requirements which must 
be met in filing applications for approval by the National Institute 
for Occupational Safety and Health of respirators or changes or 
modifications of approved respirators;
    (b) To establish a schedule of fees to be charged each applicant 
for the inspections, examinations, and testing conducted by the 
Institute under the provisions of this part;
    (c) To provide for the issuance of certificates of approval or 
modifications of certificates of approval for respirators which have 
met the applicable construction, performance, and respiratory 
protection requirements set forth in this part; and
    (d) To specify minimum requirements and to prescribe methods to be 
employed by the Institute and by the applicant in conducting 
inspections, examinations, and tests to determine the effectiveness of 
respirators used during entry into or escape from hazardous 
atmospheres.
Sec. 84.2  Definitions.

    As used in this part--
    (a) Applicant means an individual, partnership, company, 
corporation, association, or other organization that designs, 
manufactures, assembles, or controls the assembly of a respirator and 
who seeks to obtain a certificate of approval for such respirator.
    (b) Approval means a certificate or formal document issued by the 
Institute stating that an individual respirator or combination of 
respirators has met the minimum requirements of this part, and that the 
applicant is authorized to use and attach an approval label to any 
respirator, respirator container, or instruction card for any 
respirator manufactured or assembled in conformance with the plans and 
specifications upon which the approval was based, as evidence of such 
approval.
    (c) Approved means conforming to the minimum requirements of this 
part.
    (d) Auxiliary equipment means a self-contained breathing apparatus, 
the use of which is limited in underground mine rescue and recovery 
operations to situations where the wearer has ready access to fresh air 
and at least one crew equipped with approved self-contained breathing 
apparatus of 2 hours or longer rating, is in reserve at a fresh-air 
base.
    (e) Certification and Quality Assurance Branch means the 
Certification and Quality Assurance Branch, Division of Safety 
Research, Appalachian Laboratory for Occupational Safety and Health, 
National Institute for Occupational Safety and Health, 1095 Willowdale 
Road, Morgantown, West Virginia 26505-2888.
    (f) Compressed-breathing gas means oxygen or air stored in a 
compressed state and supplied to the wearer in gaseous form.
    (g) dBA means sound pressure levels in decibels, as measured with 
the A-weighted network of a standard sound level meter using slow 
response.
    (h) Dust means a solid mechanically produced particle with a size 
ranging from submicroscopic to macroscopic.
    (i) Respirators for entry into and escape from means respiratory 
devices providing protection during entry into and escape from 
hazardous atmospheres.
    (j) Respirators for escape only means respiratory devices providing 
protection only during escape from hazardous atmospheres.
    (k) A facepiece or mouthpiece is a respirator component designed to 
provide a gas-tight or dust-tight fit with the face and may include 
headbands, valves, and connections for canisters, cartridges, filters, 
or respirable gas source.
    (l) Final inspection means that activity carried out on a product 
after all manufacturing and assembly operations are completed to insure 
completeness and adherence to performance or other specifications, 
including satisfactory appearance.
    (m) Fume means a solid condensation particle, generally less than 1 
micrometer in diameter.
    (n) Gas means an aeriform fluid which is in a gaseous state at 
ordinary temperature and pressure.
    (o) Hazardous atmosphere means:
    (1) Any atmosphere containing a toxic or disease producing gas, 
vapor, dust, fume, mist, or pesticide, either immediately or not 
immediately dangerous to life or health; or
    (2) Any oxygen-deficient atmosphere.
    (p) A hood or helmet is a respirator component which covers the 
wearer's head and neck, or head, neck, and shoulders, and is supplied 
with incoming respirable air for the wearer to breathe. It may include 
a headharness and connection for a breathing tube.
    (q) Immediately dangerous to life or health means conditions that 
pose an immediate threat to life or health or conditions that pose an 
immediate threat of severe exposure to contaminants, such as 
radioactive materials, which are likely to have adverse cumulative or 
delayed effects on health.
    (r) Incoming inspection means the activity of receiving, examining, 
and accepting only those materials and parts whose quality conforms to 
specification requirements.
    (s) In-process inspection means the control of products at the 
source of production and at each step of the manufacturing process, so 
that departures from specifications can be [[Page 30358]] corrected 
before defective components or materials are assembled into the 
finished product.
    (t) Institute means the National Institute for Occupational Safety 
and Health, Department of Health and Human Services.
    (u) Liquefied-breathing gas means oxygen or air stored in liquid 
form and supplied to the wearer in a gaseous form.
    (v) Mist means a liquid condensation particle with a size ranging 
from submicroscopic to macroscopic.
    (w) MSHA means the Mine Safety and Health Administration, U.S. 
Department of Labor.
    (x) Not immediately dangerous to life or health means any hazardous 
atmosphere which may produce physical discomfort immediately, chronic 
poisoning after repeated exposure, or acute adverse physiological 
symptoms after prolonged exposure.
    (y) Oxygen-deficient atmosphere means an atmosphere which contains 
an oxygen partial pressure of less than 148 millimeters of mercury 
(19.5 percent by volume at sea level).
    (z) Powered air-purifying respirator means a device equipped with a 
facepiece, hood, or helmet, breathing tube, canister, cartridge, 
filter, canister with filter, or cartridge with filter, and a blower.
    (aa) Respirator means any device designed to provide the wearer 
with respiratory protection against inhalation of a hazardous 
atmosphere.
    (bb) Single-use respirator means a respirator that is entirely 
discarded after excessive resistance, sorbent exhaustion, or physical 
damage renders it unsuitable for further use.
    (cc) Vapor means the gaseous state of a substance that is solid or 
liquid at ordinary temperature and pressure.


Sec. 84.3  Respirators for mine rescue or other emergency use in mines.

    (a)(1) NIOSH and the Mine Safety and Health Administration (MSHA), 
U.S. Department of Labor, shall jointly review and issue certifications 
for respirators used for mine emergencies and mine rescue, including 
any associated service-life plans, users' manuals and other supporting 
documentation.
    (2) Each certification for a respirator designed for mine rescue or 
other emergency use in mines shall include, as a condition of approval, 
any use limitations related to mine safety and health.
    (b) NIOSH and MSHA shall jointly determine appropriate recall and 
retrofit remedies for field complaints or identified deficiencies 
involving any respirators used in the mining environment.

Subpart B--Application for Approval


Sec. 84.10  Application procedures.

    (a) Inspection, examination, and testing leading to the approval of 
the types of respirators classified in subpart F of this part shall be 
undertaken by the Institute only pursuant to written applications which 
meet the minimum requirements set forth in this subpart B.
    (b) Applications shall be submitted to the Certification and 
Quality Assurance Branch, and shall be accompanied by a check, bank 
draft, or money order in the amount specified in subpart C of this 
part, payable to the order of the National Institute for Occupational 
Safety and Health.
    (c) Except as provided in Sec. 84.64, the examination, inspection, 
and testing of all respirators shall be conducted by the Certification 
and Quality Assurance Branch.
    (d) Applicants, manufacturers, or their representatives may visit 
or communicate with the Certification and Quality Assurance Branch in 
order to discuss the requirements for approval of any respirator or the 
proposed designs thereof. No charge shall be made for such consultation 
and no written report shall be issued to applicants, manufacturers, or 
their representatives by the Institute as a result of such 
consultation.
    (e) Respirators having electrical or electronic components that are 
required to be permissible under chapter I of title 30 shall be tested 
in accordance with 30 CFR part 18. Applications for approval of such 
respirators by MSHA shall be submitted in writing to: MSHA, Approval 
and Certification Center, Box 251, Industrial Park Road, Triadelphia, 
West Virginia 26059.


Sec. 84.11  Contents of application.

    (a) Each application for approval shall contain a complete written 
description of the respirator for which approval is requested together 
with drawings and specifications (and lists thereof) showing full 
details of construction of the respirator and of the materials used.
    (b) Drawings shall be titled, numbered, and dated; any revision 
dates shall be shown on the drawings, and the purpose of each revision 
being sought shall be shown on the drawing or described on an 
attachment to the drawing to which it applies.
    (c) Each application for approval shall contain a proposed plan for 
quality control which meets the minimum requirements set forth in 
subpart E of this part.
    (d) Each application shall contain a statement that the respirator 
has been pretested by the applicant as prescribed in Sec. 84.64, and 
shall include the results of such tests.
    (e) Each application for approval shall contain a statement that 
the respirator and component parts submitted for approval are either 
prototypes, or made on regular production tooling, with no operation 
included which will not be incorporated in regular production 
processing.
    (The information collections contained in this section are approved 
under OMB control number 0920-0109)


Sec. 84.12  Delivery of respirators and components by applicant; 
requirements.

    (a) Each applicant shall, when an application is filed pursuant to 
Sec. 84.10, be advised by the Institute of the total number of 
respirators and component parts required for testing.
    (b) The applicant shall deliver, at his own expense, the number of 
completely assembled respirators and component parts required for 
testing, to the Certification and Quality Assurance Branch.
    (c) Respirators and component parts submitted for approval must be 
made from materials specified in the application.
    (d) One completely assembled respirator approved under the 
provisions of this part may be retained by the Institute as a 
laboratory exhibit, the remaining respirators may be returned to the 
applicant at his own expense, upon written request within 30 days after 
notice of approval. If no such request is made, the respirators will be 
disposed of by the Institute in such manner as it deems appropriate.
    (e) Where a respirator fails to meet the requirements for approval 
set forth in this part, all respirators and components delivered in 
accordance with this section may be returned to the applicant at his 
own expense, upon written request within 30 days after notice of 
disapproval. If no such request is made, the respirators will be 
disposed of by the Institute in such manner as it deems appropriate.

Subpart C--Fees


Sec. 84.20  Examination, inspection, and testing of complete respirator 
assemblies; fees.

    Except as provided in Sec. 84.22, the following fees shall be 
charged by the Institute for the examination, inspection and testing of 
complete respirator assemblies:

Self-contained breathing apparatus:                                     
  Entry and escape, 1 hour or more.............................  $3,500 
[[Page 30359]]
                                                                        
  Entry and escape, less than 1 hour...........................    2,750
  Escape only..................................................    2,000
Gas masks:                                                              
  Single hazard................................................    1,100
  Type N.......................................................    4,100
Supplied-air respirators.......................................      750
Particulate respirators........................................    1,250
Chemical cartridge respirators.................................    1,150
                                                                        

Sec. 84.21  Examination, inspection, and testing of respirator 
components or subassemblies; fees.

    Except as provided in Sec. 84.22, the following fees shall be 
charged by the Institute for the examination, inspection and testing of 
the individual respirator components or subassemblies:

Facepieces.......................................................   $450
Canisters........................................................    900
Cartridges.......................................................    600
Filters..........................................................    650
Hoses............................................................    250
Blowers..........................................................    250
Harnesses........................................................    100
                                                                        

Sec. 84.22  Unlisted fees; additional fees; payment by applicant prior 
to approval.

    (a) Applications for the examination, inspection and testing of 
complete respirator assemblies which are not listed in Sec. 84.20, or 
for the examination, inspection, and testing of respirator components 
or subassemblies which are not listed in Sec. 84.21, shall be 
accompanied by the following deposits:

Complete respirator assembly...................................   $1,500
Each individual component or subassembly.......................      500
                                                                        

    (b) The Institute reserves the right to conduct any examination, 
inspection, or test it deems necessary to determine the quality and 
effectiveness of any listed or unlisted respirator assembly or 
respirator component or subassembly, and to assess the cost of such 
examinations, inspections, or tests against the applicant prior to the 
issuance of any approval for such assembly, component, or subassembly.
    (c) The fees charged for the examination, inspection, and testing 
of unlisted respirator assemblies, unlisted individual respirator 
components or subassemblies, and for the additional examination, 
inspection, and testing of listed respirator assemblies and components 
or subassemblies shall be at the rate of $100 per day for each man-day 
required to be expended by the Institute.
    (d) Upon completion of all examinations, inspections, and tests of 
unlisted respirator assemblies or components, or following the 
completion of any additional examination, inspections, or tests of 
listed assemblies, or components or subassemblies, including retesting 
subsequent to disapproval, the Institute shall advise the applicant in 
writing of the total cost assessed and the additional amount, if any, 
which must be paid to the Institute as a condition of approval.
    (e) In the event the amount assessed by the Institute for unlisted 
assemblies, or components or subassemblies is less than the amount of 
the deposit submitted in accordance with paragraph (a) of this section, 
the Institute shall refund the overpayment upon the issuance of any 
approval or notice of disapproval.

Subpart D--Approval and Disapproval


Sec. 84.30  Certificates of approval; scope of approval.

    (a) The Institute shall issue certificates of approval pursuant to 
the provisions of this subpart only for individual, completely 
assembled respirators which have been examined, inspected, and tested, 
and which meet the minimum requirements set forth in subparts H through 
L of this part, as applicable.
    (b) The Institute will not issue certificates of approval for any 
respirator component or for any respirator subassembly.
    (c) The Institute shall not issue an informal notification of 
approval. However, if the application for approval, submitted in 
accordance with Sec. 84.11, states that the submitted respirator and 
component parts are only prototypes, the Institute will examine, 
inspect, and test such respirator and component parts in accordance 
with the provisions of this part. If, upon completion of such 
examinations, inspections and tests, it is found that the prototype 
meets the minimum requirements set forth in this part, the Institute 
may inform the applicant, in writing, of the results of the 
examinations, inspections, and tests, and may require him to resubmit 
respirators and component parts made on regular production tooling, 
with no operations included which will not be incorporated in regular 
production processing, for further examination, inspection, and 
testing, prior to issuance of the certificate of approval.
    (d) Applicants required to resubmit respirators and component parts 
made on regular production tooling, with no operation included which 
will not be incorporated in regular production processing, shall be 
charged fees in accordance with subpart C of this part.


Sec. 84.31  Certificates of approval; contents.

    (a) The certificate of approval shall contain a classification and 
a description of the respirator or combination of respirators for which 
it is issued, as provided in this part.
    (b) The certificate of approval shall specifically set forth any 
restrictions or limitations on the respirator's use in hazardous 
atmospheres.
    (c) Each certificate of approval shall be accompanied by the 
drawings and specifications (and lists thereof) submitted by the 
applicant in accordance with Sec. 84.11. These drawings and 
specifications shall be referenced in the certificate of approval, and 
shall be maintained by the applicant. The drawings and specifications 
listed in each certificate of approval shall set forth in detail the 
design and construction requirements which shall be met by the 
applicant during commercial production of the respirator.
    (d) Each certificate of approval shall be accompanied by a 
reproduction of the approval label design to be employed by the 
applicant with each approved respirator, as provided in Sec. 84.33.
    (e) No test data or specific laboratory findings will accompany any 
certificate of approval, however, the Institute will release pertinent 
test data and specific findings upon written request by the applicant, 
or as required by statute or regulation.
    (f) Each certificate of approval shall also contain the approved 
quality control plan as specified in Sec. 84.42.


Sec. 84.32  Notice of disapproval.

    (a) If, upon the completion of the examinations, inspections, and 
tests required to be conducted in accordance with the provisions of 
this part, it is found that the respirator does not meet the minimum 
requirements set forth in this part, the Institute shall issue a 
written notice of disapproval to the applicant.
    (b) Each notice of disapproval shall be accompanied by all 
pertinent data or findings with respect to the defects of the 
respirator for which approval was sought with a view to the possible 
correction of any such defects.
    (c) The Institute shall not disclose, except to the applicant or as 
required by statute or regulation, any data, findings, or other 
information with respect to any respirator for which a notice of 
disapproval is issued.


Sec. 84.33  Approval labels and markings; approval of contents; use.

    (a) Full-scale reproductions of approval labels and markings, and a 
sketch or description of the method of application and position on the 
harness, container, canister, cartridge, filter, or 
[[Page 30360]] other component, together with instructions for the use 
and maintenance of the respirator shall be submitted to the Institute 
for approval.
    (b) Approval labels shall bear the emblem of the National Institute 
for Occupational Safety and Health and the seal of the Department of 
Health and Human Services, the applicant's name and address, an 
approval number assigned by the Institute and, where appropriate, 
restrictions or limitations placed upon the use of the respirator by 
the Institute. The approval number assigned by the Institute shall be 
designated by the prefix TC and a serial number.
    (c) The Institute shall, where necessary, notify the applicant when 
additional labels, markings, or instructions will be required.
    (d) Approval labels and markings shall only be used by the 
applicant to whom they were issued.
    (e) Legible reproductions or abbreviated forms of the label 
approved by the Institute for use on each respirator shall be attached 
to or printed at the following locations:

------------------------------------------------------------------------
   Respirator type           Label type                Location         
------------------------------------------------------------------------
Self-contained         Entire...............  Harness assembly and      
 breathing apparatus.                          canister (where          
                                               applicable).             
Gas mask.............  Entire...............  Mask container and        
                                               canister.                
Supplied air           ......do.............  Respirator container or   
 respirator.                                   instruction card.        
Particulate            ......do.............  Respirator container and  
 respirator.                                   filter container.        
                       Abbreviated..........  Filters.                  
Chemical-cartridge     Entire...............  Respirator container,     
 respirator.                                   cartridge container, and 
                                               filter containers (where 
                                               applicable).             
                       Abbreviated..........  Cartridges and filters and
                                               filter containers.       
------------------------------------------------------------------------

    (f) The use of any Institute approval label obligates the applicant 
to whom it is issued to maintain or cause to be maintained the approved 
quality control sampling schedule and the acceptable quality level for 
each characteristic tested, and to assure that it is manufactured 
according to the drawings and specifications upon which the certificate 
of approval is based.
    (g) Each respirator, respirator component, and respirator container 
shall, as required by the Institute to assure quality control and 
proper use of the respirator, be labeled distinctly to show the name of 
the applicant, and the name and letters or numbers by which the 
respirator or respirator component is designated for trade purposes, 
and the lot number, serial number, or approximate date of manufacture.


Sec. 84.34  Revocation of certificates of approval.
    The Institute reserves the right to revoke, for cause, any 
certificate of approval issued pursuant to the provisions of this part. 
Such causes include, but are not limited to, misuse of approval labels 
and markings, misleading advertising, and failure to maintain or cause 
to be maintained the quality control requirements of the certificate of 
approval.


Sec. 84.35  Changes or modifications of approved respirators; issuance 
of modification of certificate of approval.

    (a) Each applicant may, if he desires to change any feature of an 
approved respirator, request a modification of the original certificate 
of approval issued by the Institute for such respirator by filing an 
application for such modification in accordance with the provisions of 
this section.
    (b) Applications shall be submitted as for an original certificate 
of approval, with a request for a modification of the existing 
certificate to cover any proposed change.
    (c) The application shall be accompanied by appropriate drawings 
and specifications, and by a proposed quality control plan which meets 
the requirements of subpart E of this part.
    (d) The application for modification, together with the 
accompanying material, shall be examined by the Institute to determine 
whether testing will be required.
    (e) The Institute shall inform the applicant of the fee required 
for any additional testing and the applicant will be charged for the 
actual cost of any examination, inspection, or test required, and such 
fees shall be submitted in accordance with the provisions of subpart C 
of this part.
    (f) If the proposed change or modification meets the requirements 
of this part, a formal certificate of modification will be issued, 
accompanied, where necessary, by a list of new and revised drawings and 
specifications covering the change(s) and reproductions of revised 
approval labels.
    (The information collections contained in this section are approved 
under OMB control number 0920-0109.)


Sec. 84.36  Delivery of changed or modified approved respirator.

    An approved respirator for which a formal certificate of 
modification has been issued shall be delivered, with proper markings 
and containers, by the applicant to the Certification and Quality 
Assurance Branch, as soon as it is commercially produced.

Subpart E--Quality Control


Sec. 84.40  Quality control plans; filing requirements.

    As a part of each application for approval or modification of 
approval submitted pursuant to this part, each applicant shall file 
with the Institute a proposed quality control plan which shall be 
designed to assure the quality of respiratory protection provided by 
the respirator for which approval is sought.


Sec. 84.41  Quality control plans; contents.

    (a) Each quality control plan shall contain provisions for the 
management of quality, including:
    (1) Requirements for the production of quality data and the use of 
quality control records;
    (2) Control of engineering drawings, documentations, and changes;
    (3) Control and calibration of measuring and test equipment;
    (4) Control of purchased material to include incoming inspection;
    (5) Lot identification, control of processes, manufacturing, 
fabrication, and assembly work conducted in the applicant's plant;
    (6) Audit of final inspection of the completed product; and
    (7) The organizational structure necessary to carry out these 
provisions.
    (b) Each provision for incoming and final inspection in the quality 
control plan shall include a procedure for the selection of a sample of 
respirators and the components thereof for testing, in accordance with 
procedures set forth in Military Standard MIL-STD-414, 11 June 1957, 
including Change Notice No. 1, ``Sampling Procedures and Tables for 
Inspection by Variables for Percent Defective,'' or an approved 
equivalent sampling procedure, or an approved 
[[Page 30361]] combination of sampling procedures. The procedure of 
Military Standard MIL-STD-105D, 29 April 1963, ``Sampling Procedures 
and Tables for Inspection by Attributes,'' is an example of an 
equivalent sampling procedure. MIL-STD-414 is incorporated by reference 
and has been approved by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from DODSSP, Standardization Document Order Desk, 700 Robbins 
Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected 
at the NIOSH, Certification and Quality Assurance Branch, 1095 
Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the 
Federal Register, 800 North Capitol Street NW., suite 700, Washington, 
DC. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, 
Certification and Quality Assurance Branch, 1095 Willowdale Road, 
Morgantown, WV 26505-2888. Incoming bulk raw material inspection or 
verification of specification, and in-process inspection shall be 
sufficient to ensure control of product quality through the 
manufacturing cycle.
    (c) The sampling procedure shall include a list of the 
characteristics to be tested by the applicant or his agent.
    (d) The characteristics listed in accordance with paragraph (c) of 
this section shall be classified according to the potential effect of 
such defect and grouped into the following classes:
    (1) Critical. A defect that judgment and experience indicate is 
likely to result in a condition immediately hazardous to life or health 
for individuals using or depending upon the respirator;
    (2) Major A. A defect, other than critical, that is likely to 
result in failure to the degree that the respirator does not provide 
any respiratory protection, or a defect that reduces protection and is 
not detectable by the user;
    (3) Major B. A defect, other than Major A or critical, that is 
likely to result in reduced respiratory protection, and is detectable 
by the user; and
    (4) Minor. A defect that is not likely to materially reduce the 
usability of the respirator for its intended purpose, or a defect that 
is a departure from established standards and has little bearing on the 
effective use or operation of the respirator.
    (e) The quality control inspection test method to be used by the 
applicant or his agent for each characteristic required to be tested 
shall be described in detail.
    (f) Each item manufactured shall be 100 percent inspected for 
defects in all critical characteristics and all defective items shall 
be rejected.
    (g) The Acceptable Quality Level (AQL) for each major or minor 
defect so classified by the applicant shall be:
    (1) Major A. 1.0 percent;
    (2) Major B. 2.5 percent; and
    (3) Minor. 4.0 percent.
    (h) Except as provided in paragraph (i) of this section, inspection 
level IV as described in MIL-STD-414, 11 June 1957, including Change 
Notice No.1, ``Sampling Procedures and Tables for Inspection by 
Variables for Percent Defective,'' or an equivalent procedure, shall be 
used for major and minor characteristics and 100 percent inspection for 
critical characteristics. Inspection level II as described in MIL-STD-
105D, 29 April 1963, ``Sampling Procedures and Tables for Inspection by 
Attributes,'' is an example of an equivalent procedure.
    (i) Subject to the approval of the Institute, where the quality 
control plan provisions for raw material, processes, manufacturing, and 
fabrication, inspections are adequate to ensure control of finished 
article quality, destructive testing of finished articles may be 
conducted at a lower level of inspection than that specified in 
paragraph (h) of this section.
    (The information collections contained in this section are approved 
under OMB control number 0920-0109)


Sec. 84.42  Proposed quality control plans; approval by the Institute.

    (a) Each proposed quality control plan submitted in accordance with 
this subpart shall be reviewed by the Institute to determine its 
effectiveness in ensuring the quality of respiratory protection 
provided by the respirator for which an approval is sought.
    (b) If the Institute determines that the proposed quality control 
plan submitted by the applicant will not ensure adequate quality 
control, the Institute shall require the applicant to modify the 
procedures and testing requirements of the plan prior to approval of 
the plan and issuance of any certificate of approval.
    (c) Approved quality control plans shall constitute a part of and 
be incorporated into any certificate of approval issued by the 
Institute, and compliance with such plans by the applicant shall be a 
condition of approval.


Sec. 84.43  Quality control records; review by the Institute; 
revocation of approval.

    (a) The applicant shall keep quality control inspection records 
sufficient to carry out the procedures required in MIL-STD-414, 11 June 
1957, including Change Notice No. 1, ``Sampling Procedures and Tables 
for Inspection by Variables for Percent Defective,'' or an approved 
equivalent sampling procedure. MIL-STD-105D, 29 April 1963, ``Sampling 
Procedures and Tables for Inspection by Attributes,'' is an example of 
an approved equivalent sampling procedure. MIL-STD-414 is incorporated 
by reference and has been approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from DODSSP, Standardization Document Order Desk, 700 
Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be 
inspected at the NIOSH, Certification and Quality Assurance Branch, 
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC. Copies of MIL-STD-105D may be inspected or obtained 
from the NIOSH, Certification and Quality Assurance Branch, 1095 
Willowdale Road, Morgantown, WV 26505-2888.
    (b) The Institute reserves the right to have its representatives 
inspect the applicant's quality control test methods, equipment, and 
records, and to interview any employee or agent of the applicant in 
regard to quality control test methods, equipment, and records.
    (c) The Institute reserves the right to revoke, for cause, any 
certificate of approval where it is found that the applicant's quality 
control test methods, equipment, or records do not ensure effective 
quality control over the respirator for which the approval was issued.
    (The information collections contained in this section are approved 
under OMB control number 0920-0109)

Subpart F--Classification of Approved Respirators; Scope of 
Approval; Atmospheric Hazards; Service Time


Sec. 84.50  Types of respirators to be approved; scope of approval.

    Approvals shall be issued for the types of respirators which have 
been classified pursuant to this subpart F, have been inspected, 
examined and tested by the Institute, in accordance with the provisions 
of subparts G through L of this part, and have been found to provide 
respiratory protection for fixed periods of time against the hazards 
specified in such approval.


Sec. 84.51  Entry and escape, or escape only; classification.

    Respirators described in subparts H through L of this part shall be 
classified for use as follows:
    (a) Entry and escape. Respirators designed and approved for use 
during [[Page 30362]] entry into a hazardous atmosphere, and for escape 
from a hazardous atmosphere; or
    (b) Escape only. Respirators designed and approved for use only 
during escape from a hazardous atmosphere.


Sec. 84.52  Respiratory hazards; classification.

    Respirators described in subparts H through L of this part shall be 
classified as approved for use against any or all of the following 
respiratory hazards:
    (a) Oxygen deficiency;
    (b) Gases and vapors; and
    (c) Particles, including dusts, fumes and mists.


Sec. 84.53  Service time; classification.

    (a) Respirators described in subparts H through L of this part 
shall be classified, where applicable, as approved for use during the 
following prescribed service times:
    (1) Four hours;
    (2) Three hours;
    (3) Two hours;
    (4) One hour;
    (5) Forty-five minutes;
    (6) Thirty minutes;
    (7) Fifteen minutes;
    (8) Ten minutes;
    (9) Five minutes; or
    (10) Three minutes.
    (b) Other service times may be prescribed by the Institute.
Subpart G--General Construction and Performance Requirements


Sec. 84.60  Construction and performance requirements; general.

    (a) The Institute shall issue approvals for the types of 
respirators described in subparts H through L of this part which have 
met the minimum requirements set forth for such respirators in this 
part.
    (b) In addition to the types of respirators specified in subparts H 
through L of this part, the Institute shall issue approvals for other 
respiratory protective devices not specifically described in this part 
subject to such additional requirements as may be imposed in accordance 
with Sec. 84.63(c).


Sec. 84.61  General construction requirements.

    (a) Respirators will not be accepted by the Institute for 
examination, inspection and testing unless they are designed on sound 
engineering and scientific principles, constructed of suitable 
materials and evidence good workmanship.
    (b) Respirator components which come into contact with the wearer's 
skin shall be made of nonirritating materials.
    (c) Components replaced during or after use shall be constructed of 
materials which will not be damaged by normal handling.
    (d) Mouthpieces, hoods, helmets, and facepieces, except those 
employed in single-use respirators, shall be constructed of materials 
which will withstand repeated disinfection as recommended by the 
applicant in his instructions for use of the device.


Sec. 84.62  Component parts; minimum requirements.

    (a) The component parts of each respirator shall be:
    (1) Designed, constructed, and fitted to insure against creation of 
any hazard to the wearer;
    (2) Assembled to permit easy access for inspection and repair of 
functional parts; and
    (3) Assembled to permit easy access to parts which require periodic 
cleaning and disinfecting.
    (b) Replacement parts shall be designed and constructed to permit 
easy installation and to maintain the effectiveness of the respirator.


Sec. 84.63  Test requirements; general.

    (a) Each respirator and respirator component shall when tested by 
the applicant and by the Institute, and meet the applicable 
requirements set forth in subparts H through L of this part.
    (b) Where a combination respirator is assembled from two or more 
types of respirators, as described in this part, each of the individual 
respirator types which have been combined shall, as applicable, meet 
the minimum requirements for such respirators set forth in subparts H 
through L of this part, and such combination respirators, except as 
specified in Sec. 84.70(b)(2), will be classified by the type of 
respirator in the combination which provides the least protection to 
the user.
    (c) In addition to the minimum requirements set forth in subparts H 
through L of this part, the Institute reserves the right to require, as 
a further condition of approval, any additional requirements deemed 
necessary to establish the quality, effectiveness, and safety of any 
respirator used as protection against hazardous atmospheres.
    (d) Where it is determined after receipt of an application that 
additional requirements will be required for approval, the Institute 
will notify the applicant in writing of these additional requirements, 
and necessary examinations, inspections, or tests, stating generally 
the reasons for such requirements, examinations, inspections, or tests.


Sec. 84.64  Pretesting by applicant; approval of test methods.

    (a) Prior to making or filing any application for approval or 
modification of approval, the applicant shall conduct, or cause to be 
conducted, examinations, inspections, and tests of respirator 
performance which are equal to or exceed the severity of those 
prescribed in this part.
    (b) With the application, the applicant shall provide a statement 
to the Institute showing the types and results of the examinations, 
inspections, and tests required under paragraph (a) of this section and 
state that the respirator meets the minimum requirements of subparts H 
through L of this part, as applicable. Complete examination, 
inspection, and test data shall be retained on file by the applicant 
and be submitted, upon request, to the Institute.
    (c) The Institute may, upon written request by the applicant, 
provide drawings and descriptions of its test equipment and otherwise 
assist the applicant in establishing a test laboratory or securing the 
services of a testing agency.
    (d) No approval will be issued until the Institute has validated 
the applicant's test results.


Sec. 84.65  Conduct of examinations, inspections, and tests by the 
Institute; assistance by applicant; observers; recorded data; public 
demonstrations.
    (a) All examinations, inspections, and tests conducted pursuant to 
subparts H through L of this part will be under the sole direction and 
control of the Institute.
    (b) The Institute may, as a condition of approval, require the 
assistance of the applicant or agents of the applicant during the 
assembly, disassembly, or preparation of any respirator or respirator 
component prior to testing or in the operation of such equipment during 
testing.
    (c) Only Institute personnel, persons assisting the Institute 
pursuant to paragraph (b) of this section, and such other persons as 
are requested by the Institute or the applicant to be observers, shall 
be present during any examination, inspection, or test conducted prior 
to the issuance of an approval by the Institute for the equipment under 
consideration.
    (d) The Institute shall hold as confidential any analyses, 
drawings, specifications, or materials submitted by the applicant and 
shall not disclose any principles or patentable features of such 
equipment, except as required by statute or regulation.
    (e) As a condition of each approval issued for any respirator, the 
Institute [[Page 30363]] reserves the right, following the issuance of 
such approval, to conduct such public tests and demonstrations of the 
approved respiratory equipment as is deemed appropriate.


Sec. 84.66  Withdrawal of applications; refund of fees.

    (a) Any applicant may, upon a written request submitted to the 
Institute, withdraw any application for approval of any respirator.
    (b) Upon receipt of a written request for the withdrawal of an 
application, the Institute shall determine the total man-days expended 
and the amount due for services already performed during the course of 
any examinations, inspections, or tests conducted pursuant to such 
application. The total amount due shall be determined in accordance 
with the provisions of Sec. 84.22 and assessed against the fees 
submitted by the applicant. If the total amount assessed is less than 
the fees submitted, the Institute shall refund the balance together 
with a statement of the charges made for services rendered.

Subpart H--Self-Contained Breathing Apparatus


Sec. 84.70  Self-contained breathing apparatus; description.

    (a) Self-contained breathing apparatus, including all completely 
assembled, portable, self-contained devices designed for use as 
respiratory protection during entry into and escape from or escape only 
from hazardous atmospheres, are described as follows:
    (1) Closed-circuit apparatus. An apparatus of the type in which the 
exhalation is rebreathed by the wearer after the carbon dioxide has 
been effectively removed and a suitable oxygen concentration restored 
from sources composed of:
    (i) Compressed oxygen; or
    (ii) Chemical oxygen; or
    (iii) Liquid-oxygen.
    (2) Open-circuit apparatus. An apparatus of the following types 
from which exhalation is vented to the atmosphere and not rebreathed:
    (i) Demand-type apparatus. An apparatus in which the pressure 
inside the facepiece in relation to the immediate environment is 
positive during exhalation and negative during inhalation; or
    (ii) Pressure-demand-type apparatus. An apparatus in which the 
pressure inside the facepiece in relation to the immediate environment 
is positive during both inhalation and exhalation.
    (b) The following respirators may be classified as designed and 
approved for use during emergency entry into a hazardous atmosphere:
    (1) A combination respirator which includes a self-contained 
breathing apparatus; and
    (2) A Type ``C'' or Type ``CE'' supplied air respirator, where--
    (i) The self-contained breathing apparatus is classified for 3-, 5-
, or 10-minute service time and the air line supply is used during 
entry; or
    (ii) The self-contained breathing apparatus is classified for 15 
minutes or longer service time and not more than 20 percent of the 
rated capacity of the air supply is used during entry.
    (c) Self-contained breathing apparatus classified for less than 1 
hour service time will not be approved for use during underground mine 
rescue and recovery operations except as auxiliary equipment.
    (d) Self-contained breathing apparatus classified for less than 30 
minutes' service time will not be approved for use as auxiliary 
equipment during underground mine rescue and recovery operations.


Sec. 84.71  Self-contained breathing apparatus; required components.

    (a) Each self-contained breathing apparatus described in Sec. 84.70 
shall, where its design requires, contain the following component 
parts:
    (1) Facepiece or mouthpiece, and noseclip;
    (2) Respirable breathing gas container;
    (3) Supply of respirable breathing gas;
    (4) Gas pressure or liquid level gages;
    (5) Timer;
    (6) Remaining service life indicator or warning device;
    (7) Hand-operated valves;
    (8) Breathing bag;
    (9) Safety relief valve or safety relief system; and
    (10) Harness.
    (b) The components of each self-contained breathing apparatus shall 
meet the minimum construction requirements set forth in subpart G of 
this part.


Sec. 84.72  Breathing tubes; minimum requirements. Flexible breathing 
tubes used in conjunction with breathing apparatus shall be designed 
and constructed to prevent:

    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces and mouthpieces;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm 
pressure.


Sec. 84.73  Harnesses; installation and construction; minimum 
requirements.

    (a) Each apparatus shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
apparatus in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of apparatus parts and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.


Sec. 84.74  Apparatus containers; minimum requirements.

    (a) Apparatus may be equipped with a substantial, durable container 
bearing markings which show the applicant's name, the type and 
commercial designation of the respirator it contains, and all 
appropriate approval labels.
    (b) Containers supplied by the applicant for carrying or storing 
self-contained breathing apparatus will be inspected, examined, and 
tested as components of the respirator for which approval is sought.
    (c) Containers for self-contained breathing apparatus shall be 
designed and constructed to permit easy removal of the apparatus.


Sec. 84.75  Half-mask facepieces, full facepieces, mouthpieces; fit; 
minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes, 
either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for the optional use of 
corrective spectacles or lenses which shall not reduce the respiratory 
protective qualities of the apparatus.
    (c) Apparatus with mouthpieces shall be equipped with noseclips 
which are securely attached to the mouthpiece or apparatus and provide 
an airtight seal.
    (d) Facepieces shall be designed to prevent eyepiece, spectacle, 
and lens fogging.


Sec. 84.76  Facepieces; eyepieces; minimum requirements.

    (a) Facepieces shall be designed and constructed to provide 
adequate vision which is not distorted by the eyepiece.
    (b) All eyepieces shall be designed and constructed to be impact 
and penetration resistant. Federal Specification, Mask, Air Line: and 
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 
with interim amendment-1, July 30, 1969, is an example of an 
appropriate standard for determining impact and penetration resistance. 
Copies of GGG-M-125d may be obtained from the NIOSH, Certification and 
Quality Assurance [[Page 30364]] Branch, 1095 Willowdale Road, 
Morgantown, WV 26505-2888.


Sec. 84.77  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against damage and distortion.
    (b) Exhalation valves shall be--
    (1) Protected against external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.


Sec. 84.78  Head harnesses; minimum requirements.

    (a) Facepieces shall be equipped with adjustable and replaceable 
head harnesses designed and constructed to provide adequate tension 
during suspension and an even distribution of pressure over the entire 
area in contact with the face.
    (b) Mouthpieces shall be equipped, where applicable, with 
adjustable and replaceable harnesses designed and constructed to hold 
the mouthpiece in place.


Sec. 84.79  Breathing gas; minimum requirements.
    (a) Breathing gas used to supply apparatus shall be respirable and 
contain no less than 19.5 (dry atmosphere) volume percent of oxygen.
    (b) Oxygen, including liquid oxygen, shall contain not less than 
99.0 percent, by volume, of pure O<INF>2, not more than 0.03%, by 
volume, carbon dioxide, and not more than 0.001%, by volume, carbon 
monoxide. Methods for making these determinations can be found in the 
U.S. Pharmacopeia National Formulary. Containers used for oxygen must 
not be treated with any toxic, sleep-inducing, narcosis-producing, or 
respiratory tract irritating compounds.
    (c) Compressed, gaseous breathing air shall meet the applicable 
minimum grade requirements for Type I gaseous air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade D or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from 
American National Standards Institute, Inc., 1430 Broadway, New York, 
NY 10018. Copies may be inspected at the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888, or at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (d) Compressed, liquefied breathing air shall meet the applicable 
minimum grade requirements for Type II liquid air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade B or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from 
American National Standards Institute, Inc., 1430 Broadway, New York, 
NY 10018. Copies may be inspected at the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888, or at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.


Sec. 84.80  Interchangeability of oxygen and air prohibited.

    Approvals shall not be issued by the Institute for any apparatus, 
combination of respirator assemblies, or any apparatus or respirator 
component which is designed or constructed to permit the 
interchangeable use of oxygen and air.


Sec. 84.81  Compressed breathing gas and liquefied breathing gas 
containers; minimum requirements.

    (a) Compressed breathing gas and liquefied breathing gas containers 
shall meet the minimum requirements of the Department of Transportation 
for interstate shipment of such containers when fully charged.
    (b) Such containers shall be permanently and legibly marked to 
identify their contents, e.g., compressed breathing air, compressed 
breathing oxygen, liquefied breathing air, or liquefied breathing 
oxygen.
    (c) Containers normally removed from apparatus for refilling shall 
be equipped with a dial indicating gage which shows the pressure in the 
container.
    (d) Compressed breathing gas contained valves or a separate 
charging system or adapter provided with each apparatus shall be 
equipped with outlet threads specified for the service by the American 
Standards Association, Compressed Gas Cylinder Valve Outlet and Inlet 
Connections, B57.1-1965. B57.1-1965 is incorporated by reference and 
has been approved by the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from 
American National Standards Institute, Inc., 1430 Broadway, New York, 
NY Copies may be inspected at the NIOSH, Certification and Quality 
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC.


Sec. 84.82  Gas pressure gages; minimum requirements.

    (a) Gas pressure gages employed on compressed breathing gas 
containers shall be calibrated in pounds per square inch.
    (b) Liquid-level gages shall be calibrated in fractions of total 
container capacity, or in units of liquid volume.
    (c) Gas pressure gages other than those specified in paragraphs (a) 
and (b) of this section shall be calibrated in:
    (1) Pounds per square inch; or
    (2) In fractions of total container capacity; or
    (3) Both in pounds per square inch and fractions of total container 
capacity.
    (d)(1) Dial-indicating gages shall be reliable to within 
<plus-minus>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.<SUP>2 (1,000 pounds per square inch gage) or 
when the liquid level is at one-half.
    (g) Where gages are connected to the apparatus through a gage line, 
the gage and line shall be capable of being isolated from the apparatus 
except where the failure of the gage or line would not impair the 
performance or service life of the apparatus.
    (h) Oxygen pressure gages shall have the words ``Oxygen'' and ``Use 
No Oil'' marked prominently on the gage.
    (i)(1) Apparatus using compressed breathing gas, except apparatus 
classified for escape only, shall be equipped with gages visible to the 
wearer which indicate the remaining gas content in the container.
    (2) Apparatus using liquefied breathing gas, except apparatus 
classified for escape only, shall be equipped with gages visible to the 
wearer which indicate the remaining liquid content in the container; 
[[Page 30365]] however, where the liquid content cannot be rapidly 
vented, and the service time of the device begins immediately after 
filling, a timer shall be provided in place of a visible gage.
Sec. 84.83  Timers; elapsed time indicators; remaining service life 
indicators; minimum requirements.

    (a) Elapsed time indicators shall be provided for apparatus with a 
chemical oxygen source, except:
    (1) Apparatus used for escape only; or
    (2) Liquefied breathing gas apparatus equipped with gages visible 
to the wearer which indicate the remaining liquid content in the 
container.
    (b) The timer or other indicator shall be accurately calibrated in 
minutes of remaining service life.
    (c) Timers shall be readable by sight and by touch during use by 
the wearer.
    (d) Timers shall be equipped with automatically preset alarms which 
will warn the wearer for a period of 7 seconds or more after the preset 
time has elapsed.
    (e) Remaining service-life indicators or warning devices shall be 
provided in addition to a pressure gage on compressed gas self-
contained breathing apparatus, except apparatus used for escape only, 
and shall operate automatically without preadjustment by the wearer.
    (f) Each remaining service-life indicator or warning device shall 
give an alarm when the remaining service life of the apparatus is 
reduced within a range of 20 to 25 percent of its rated service time.


Sec. 84.84  Hand-operated valves; minimum requirements.

    (a) Hand-operated valves shall be designed and constructed to 
prevent removal of the stem from the valve body during normal usage to 
insure against a sudden release of the full pressure of the container 
when the valve is opened.
    (b) Valves shall be designed or positioned to prevent accidental 
opening and closing, and damage from external forces.
    (c) Valves operated during use of the apparatus shall be installed 
in locations where they can be readily adjusted by the wearer.
    (d) Main-line valves, designed and constructed to conserve gas in 
the event of a regulator or demand valve failure, shall be provided in 
addition to gas container valves, except when such failure will not 
affect performance.
    (e) Hand-operated bypass systems designed and constructed to permit 
the wearer to breathe and to conserve his gas supply in the event of a 
regulator or demand valve failure, shall be provided where necessary.
    (f) Valves installed on apparatus shall be clearly distinguishable 
from one another by sight and touch.
    (g) The bypass system valve control shall be colored red.
    (h) A main-line or bypass valve or system will not be required on 
apparatus for escape only.
    (i) Safety relief valves or systems, designed and constructed to 
release excess pressure in the breathing circuit, shall be provided on 
closed-circuit apparatus, and shall meet the following requirements:
    (1) The relief valve or system shall operate automatically when the 
pressure in the breathing circuit on the inhalation side of the 
breathing bag reaches 13 mm. (one-half inch) water-column height of 
pressure above the minimum pressure required to fill the breathing bag, 
within the breathing resistance requirements for the apparatus.
    (2) The relief valve or system shall be designed to prevent 
external atmospheres from entering the breathing circuit.
    (3) The relief valve or system shall be designed to permit manual 
overriding for test purposes and in the event of a failure in the valve 
or system.


Sec. 84.85  Breathing bags; minimum requirements.

    (a) Breathing bags shall have sufficient volume to prevent gas 
waste during exhalation and to provide an adequate reserve for 
inhalation.
    (b) Breathing bags shall be constructed of materials which are 
flexible and resistant to gasoline vapors.
    (c) Breathing bags shall be installed in a location which will 
protect them from damage or collapse by external forces, except on 
apparatus classified for escape only.


Sec. 84.86  Component parts exposed to oxygen pressures; minimum 
requirements.

    Each applicant shall certify that the materials employed in the 
construction of component parts exposed to oxygen pressures above 
atmospheric pressure are safe and compatible for their intended use.


Sec. 84.87  Compressed gas filters; minimum requirements.

    All self-contained breathing apparatus using compressed gas shall 
have a filter downstream of the gas source to effectively remove 
particles from the gas stream.


Sec. 84.88  Breathing bag test.

    (a) Breathing bags will be tested in an air atmosphere saturated 
with gasoline vapor at room temperature (24-30  deg.C./75-85  deg.F.) 
for a continuous period of twice the rated time of the apparatus 
(except for apparatus for escape only where the test period shall be 
the rated time of the apparatus).
    (b) The bag will be operated during this test by a breathing 
machine with 24 respirations per minute and a minute-volume of 40 
liters.
    (c) A breathing machine cam with a work rate of 622 kp.-m./min. 
will be used. The dimensions of a suitable breathing machine cam are 
available from the Institute upon request.
    (d) The air within the bag(s) shall not contain more than 100 parts 
per million of gasoline vapor at the end of the test.


Sec. 84.89  Weight requirement.

    (a) The completely assembled and fully charged apparatus shall not 
weigh more than 16 kg. (35 pounds); however, where the weight decreases 
by more than 25 percent of its initial charge weight during its rated 
service life, the maximum allowable weight of a completely assembled 
and fully charged apparatus shall be 18 kg. (40 pounds).
    (b) Where an apparatus employs equipment which contributes 
materially to the wearer's comfort, e.g., a cooling system, the 
completely assembled and fully charged apparatus shall not weigh more 
than 18 kg. (40 pounds) regardless of the decrease in weight during 
use.


Sec. 84.90  Breathing resistance test; inhalation.

    (a) Resistance to inhalation airflow will be measured in the 
facepiece or mouthpiece while the apparatus is operated by a breathing 
machine as described in Sec. 84.88.
    (b) The inhalation resistance of open-circuit apparatus shall not 
exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120 
liters per minute).
    (c) The inhalation resistance of closed-circuit apparatus shall not 
exceed the difference between exhalation resistance (Sec. 84.91(e)) and 
10 cm. (4 inches) water-column height.


Sec. 84.91  Breathing resistance test; exhalation.

    (a) Resistance to exhalation airflow will be measured in the 
facepiece or mouthpiece of open-circuit apparatus with air flowing at a 
continuous rate of 85 liters per minute.
    (b) The exhalation resistance of demand apparatus shall not exceed 
25 mm. (1 inch) water-column height.
    (c) The exhalation resistance of pressure-demand apparatus shall 
not exceed the static pressure in the facepiece by more than 51 mm. (2 
inches) water-column height.
    (d) The static pressure (at zero flow) in the facepiece shall not 
exceed 38 mm. (1.5 inches) water-column height. [[Page 30366]] 
    (e) Resistance to exhalation airflow will be measured in the 
facepiece or mouthpiece of closed-circuit apparatus with a breathing 
machine as described in Sec. 84.88, and the exhalation resistance shall 
not exceed 51 mm. (2 inches) water-column height.


Sec. 84.92  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. (1 inch) water-column height while in a normal 
operating position.
    (b) Leakage between the valve and the valve seat shall not exceed 
30 milliliters per minute.


Sec. 84.93  Gas flow test; open-circuit apparatus.

    (a) A static-flow test will be performed on all open-circuit 
apparatus.
    (b) The flow from the apparatus shall be greater than 200 liters 
per minute when the pressure in the facepiece of demand-apparatus is 
lowered by 51 mm. (2 inches) water-column height when full container 
pressure is applied.
    (c) Where pressure demand apparatus are tested, the flow will be 
measured at zero gage pressure in the facepiece.
    (d) Where apparatus with compressed-breathing-gas containers are 
tested, the flow test shall also be made with 3,450 kN/m.\2\ (500 
p.s.i.g.) container pressure applied.


Sec. 84.94  Gas flow test; closed-circuit apparatus.

    (a) Where oxygen is supplied by a constant-flow device only, the 
rate of flow shall be at least 3 liters per minute for the entire rated 
service time of the apparatus.
    (b) Where constant flow is used in conjunction with demand flow, 
the constant flow shall be greater than 1.5 liters per minute for the 
entire rated service time.
    (c) All demand-flow devices shall provide at least 30 liters of 
oxygen per minute when in the fully open position.


Sec. 84.95  Service time test; open-circuit apparatus.

    (a) Service time will be measured with a breathing machine as 
described in Sec. 84.88.
    (b) The open-circuit apparatus will be classified according to the 
length of time it supplies air or oxygen to the breathing machine.
    (c) The service time obtained on this test will be used to classify 
the open-circuit apparatus in accordance with Sec. 84.53.


Sec. 84.96  Service time test; closed-circuit apparatus.

    (a) The closed-circuit apparatus will be classified according to 
the length of time it supplies adequate breathing gas to the wearer 
during man test No. 4 described in Table 4 of this subpart.
    (b) The service time obtained on man test No. 4 will be used to 
classify the closed-circuit apparatus in accordance with Sec. 84.53.


Sec. 84.97  Test for carbon dioxide in inspired gas; open- and closed-
circuit apparatus; maximum allowable limits.

    (a) Open-circuit apparatus:
    (1) The concentration of carbon dioxide in inspired gas in open-
circuit apparatus will be measured at the mouth while the apparatus 
mounted on a dummy head is operated by a breathing machine. An 
acceptable method for measuring the concentration of carbon dioxide is 
described in Bureau of Mines Report of Investigations 6865, A Machine-
Test Method for Measuring Carbon Dioxide in the Inspired Air of Self-
Contained Breathing Apparatus, 1966. Copies of Report of Investigations 
6865 may be inspected or obtained from the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV. 26505-
2888.
    (2) The breathing rate will be 14.5 respirations per minute with a 
minute-volume of 10.5 liters.
    (3) A sedentary breathing machine cam will be used.
    (4) The apparatus will be tested at a temperature of 27 
<plus-minus> 2 deg. C. (80 <plus-minus> 5 deg. F.).
    (5) A concentration of 5 percent carbon dioxide in air will be 
exhaled into the facepiece.
    (b) Closed-circuit apparatus. The concentration of carbon dioxide 
in inspired gas in closed-circuit apparatus will be measured at the 
mouth while the parts of the apparatus contributing to dead-air space 
are mounted on a dummy head and operated by the breathing machine as in 
paragraphs (a) (1) through (5) of this section.
    (c) During the testing required by paragraphs (a) and (b) of this 
section, the concentration of carbon dioxide in inspired gas at the 
mouth will be continuously recorded, and the maximum average 
concentration during the inhalation portion of the breathing cycle 
shall not exceed the following limits:

------------------------------------------------------------------------
                                                    Maximum allowable   
                                                  average concentration 
           Where the service time is               of carbon dioxide in 
                                                 inspired air percent by
                                                          volume        
------------------------------------------------------------------------
Not more than 30 minutes.......................                      2.5
1 hour.........................................                      2.0
2 hours........................................                      1.5
3 hours........................................                      1.0
4 hours........................................                      1.0
------------------------------------------------------------------------

    (d) In addition to the test requirements for closed-circuit 
apparatus set forth in paragraph (b) of this section, gas samples will 
be taken during the course of the man tests described in Tables 1, 2, 
3, and 4 of this subpart. These gas samples will be taken from the 
closed-circuit apparatus at a point downstream of the carbon dioxide 
sorbent, and they shall not contain more than 0.5 percent carbon 
dioxide at any time, except on apparatus for escape only, using a 
mouthpiece only, the sample shall not contain more than 1.5 percent 
carbon dioxide at any time.


Sec. 84.98  Tests during low temperature operation.

    (a) The applicant shall specify the minimum temperature for safe 
operation and two persons will perform the tests described in 
paragraphs (c) and (d) of this section, wearing the apparatus according 
to applicant's directions. At the specified temperature, the apparatus 
shall meet all the requirements described in paragraph (e) of this 
section.
    (b) The apparatus will be precooled at the specified minimum 
temperature for 4 hours.
    (c) The apparatus will be worn in the low temperature chamber for 
30 minutes, or for the service time of the apparatus, whichever is 
less.
    (d) During the test period, alternate 1-minute periods of exercise 
and rest will be required with the exercise periods consisting of 
stepping onto and off a box 21.5 cm. (8\1/2\ inches) high at a rate of 
30 cycles per minute.
    (e)(1) The apparatus shall function satisfactorily at the specified 
minimum temperature on duplicate tests.
    (2) The wearer shall have sufficient unobscured vision to perform 
the work.
    (3) The wearer shall not experience undue discomfort because of 
airflow restriction or other physical or chemical changes in the 
operation of the apparatus.
    (f) Auxiliary low-temperature parts which are commercially 
available to the user may be used on the apparatus to meet the 
requirements described in paragraph (e) of this section.


Sec. 84.99  Man tests; testing conditions; general requirements.

    (a) The man tests described in Tables 1, 2, 3, and 4 of this 
subpart represent the workload performed in the mining, mineral, or 
allied industries by a person wearing the apparatus tested.
    (b) The apparatus tested will be worn by Institute personnel 
trained in the use of self-contained breathing apparatus, and the 
wearer will, before participating in these tests, pass a physical 
[[Page 30367]] examination conducted by a qualified physician.
    (c) All man tests will be conducted by the Institute.
    (d) The apparatus will be examined before each man test to ensure 
that it is in proper working order.
    (e) Breathing resistance will be measured within the facepiece or 
mouthpiece and the wearer's pulse and respiration rate will be recorded 
during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.
    (f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.
    (g) If man tests are not completed through no fault of the 
apparatus, the test will be repeated.


Sec. 84.100  Man tests 1, 2, 3, and 4; requirements.

    Man tests 1, 2, 3, and 4, set forth in Tables 1, 2, 3, and 4 of 
this subpart, respectively, prescribe the duration and sequence of 
specific activities. These tests will be conducted to--
    (a) Familiarize the wearer with the apparatus during use;
    (b) Provide for a gradual increase in activity;
    (c) Evaluate the apparatus under different types of work and 
physical orientation; and
    (d) Provide information on the operating and breathing 
characteristics of the apparatus during actual use.


Sec. 84.101  Man test 5; requirements.

    (a) Test 5 will be conducted to determine the maximum length of 
time the apparatus will supply the respiratory needs of the wearer 
while he is sitting at rest.
    (b) The wearer will manipulate the devices controlling the supply 
of breathing gas to the advantage of the apparatus.
    (c) Samples of inspiration from within the apparatus facepiece or 
mouthpiece shall be taken once every 15 minutes, and shall meet the 
minimum requirement for oxygen specified in Sec. 84.79(a), and the 
maximum allowable average concentration of carbon dioxide specified in 
Sec. 84.97(c).
    (d) One sample of inspiration will be taken in the case of 3-, 5-, 
and 10-minute apparatus.


Sec. 84.102  Man test 6; requirements.

    (a) Man test 6 will be conducted with respect to liquefied 
breathing gas apparatus only.
    (b) This test will be conducted to evaluate operation of the 
apparatus in other than vertical positions.
    (c) The wearer will lie face downward for one-fourth the service 
life of the apparatus with a full charge of liquefied breathing gas, 
and then a one-quarter full charge of liquefied breathing gas.
    (d) The test will be repeated with the wearer lying on each side 
and on his back.
    (e) The oxygen content of the gas supplied to the wearer by the 
apparatus will be continuously measured.


Sec. 84.103  Man tests; performance requirements.

    (a) The apparatus shall satisfy the respiratory requirements of the 
wearer for the classified service time.
    (b) Fogging of the eyepiece shall not obscure the wearer's vision, 
and the wearer shall not experience undue discomfort because of fit or 
other characteristics of the apparatus.
    (c) When the ambient temperature during testing is 24<plus-minus>6 
deg.C. (75<plus-minus>10  deg.F.), the maximum temperature of inspired 
air recorded during man tests shall not exceed the following, after 
correction for deviation from 24  deg.C. (75  deg.F.):

------------------------------------------------------------------------
                                 Where percent     Maximum permissible  
                                   relative      temperature of inspired
     Where service life of        humidity of    air shall not exceed-- 
        apparatus is--           inspired air  -------------------------
                                     is--          deg.F.       deg.C.  
------------------------------------------------------------------------
\1/4\ hour or less............           0-100          135           57
\1/4\ hour to \3/4\ hour......            0-50                          
                                        50-100          125             
                                                    \1\ 110           52
                                                                  \1\ 43
1 to 2 hours..................            0-50                          
                                        50-100          115             
                                                     \1\105           46
                                                                   \1\41
3 hours.......................            0-50                          
                                        50-100          110             
                                                     \1\100           43
                                                                  \1\ 38
4 hours.......................            0-50                          
                                        50-100          105             
                                                     \1\ 95           41
                                                                  \1\ 35
------------------------------------------------------------------------
\1\ Where percent relative humidity is 50-100 and apparatus is designed 
  for escape only, these maximum permissible temperatures will be       
  increased by 5 deg.C (10 deg.F).                                      

Sec. 84.104  Gas tightness test; minimum requirements.

    (a) Each apparatus will be tested for tightness by persons wearing 
it in an atmosphere of 1,000 p.p.m. isoamyl acetate.
    (b) Six persons will each wear the apparatus in the test 
concentrations specified in paragraph (a) of this section for 2 minutes 
and none shall detect the odor or taste of the test vapor.

Tables to Subpart H of Part 84

                                      Table 1.--Duration and Sequence of Specific Activities for Test 1, in Minutes                                     
                                                               [42 CFR part 84, subpart H]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Service time--                                              
                                            ------------------------------------------------------------------------------------------------------------
                  Activity                                                                                                                 2, 3, and 4  
                                              3 minutes    5 minutes    10 minutes   15 minutes   30 minutes   45 minutes     1 hour          hours     
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings......................  ...........  ...........  ...........            2            2            2            2  Perform 1 hour  
                                                                                                                                         test 2, 3, or 4
                                                                                                                                         times          
                                                                                                                                         respectively.  
[[Page 30368]]
                                                                                                                                                        
Walks at 4.8 km. (3 miles) per hour........            3            5            3            4            8           12           18                  
Sampling and readings......................  ...........  ...........            2            2            2            2            2                  
Walks at 4.8 km. (3 miles) per hour........  ...........  ...........            3            5            8           12           18                  
Sampling and readings......................  ...........  ...........            2            2            2            2            2  ................
Walks at 4.8 km. (3 miles) per hour........  ...........  ...........  ...........  ...........            6           13           16                  
Sampling and readings......................  ...........  ...........  ...........  ...........            2            2            2  ................
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                      Table 2.--Duration and Sequence of Specific Activities For Test 2, in Minutes                                     
                                                               [42 CFR part 84, subpart H]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Service time--                                                   
                                  ----------------------------------------------------------------------------------------------------------------------
             Activity                                                                                                                   2, 3 and 4 hours
                                    3 minutes    5 minutes     10 minutes     15 minutes     30 minutes     45 minutes       1 hour            \1\      
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings............  ...........  ...........  .............  2............  2............  2............  2............  2               
Walks at 4.8 km. (3 miles) per     ...........  ...........  1............  1............  3............  4............  6............  10.             
 hour.                                                                                                                                                  
Carries 23 kg. (50 pound) weight   ...........  ...........  1 time in 2    1 time in 2    2 times in 4   3 times in 6   4 times in 8   5 times in 10   
 over overcast.                                               minutes.       minutes.       minutes.       minutes.       minutes.       minutes.       
Walks at 4.8 km. (3 miles) per     ...........  ...........  .............  1............  3............  3............  3............  5.              
 hour.                                                                                                                                                  
Climbs vertical treadmill \2\ (or            1            1  1............  1............  1............  1............  1............  1.              
 equivalent).                                                                                                                                           
Walks at 4.8 km. (3 miles) per     ...........            1  1............  .............  .............  2............  3............  5               
 hour.                                                                                                                                                  
Climbs vertical treadmill (or      ...........            1  .............  .............  .............  1............  1............  1.              
 equivalent).                                                                                                                                           
Sampling and readings............  ...........  ...........  .............  .............  2............  2............  2............  2.              
Walks at 4.8 km. (3 miles) per     ...........  ...........  .............  2............  2............  3............  5............  11.             
 hour.                                                                                                                                                  
Climbs vertical treadmill (or      ...........  ...........  .............  1............  1............  1............  1............  1.              
 equivalent).                                                                                                                                           
Carries 23 kg. (50 pound) weight   ...........  ...........  .............  1 time in 2    3 times in 6   4 times in 8   5 times in 10  5 times in 10   
 over overcast.                                                              minutes.       minutes.       minutes.       minutes.       minutes.       
Sampling and readings............  ...........  ...........  2............  .............  .............  2............  2............  2.              
Walks at 4.8 km. (3 miles) per     ...........  ...........  .............  1............  3............  3............  3............  ................
 hour.                                                                                                                                                  
Climbs vertical treadmill (or      ...........  ...........  1............  1............  1............  1............  1............  Then repeat     
 equivalent).                                                                                                                            above          
                                                                                                                                         activities     
                                                                                                                                         once.          
Walks at 4.8 km. (3 miles) per     ...........  ...........  2............  .............  .............  2............  3              ................
 hour.                                                                                                                                                  
Climbs vertical treadmill (or      ...........  ...........  .............  .............  .............  1............  1............  ................
 equivalent).                                                                                                                                           
Carries 20 kg. (45 pound) weight             1  ...........  .............  .............  .............  .............  2............  ................
 and walks at 4.8 km. (3 miles)                                                                                                                         
 per hour.                                                                                                                                              
Walks at 4.8 km. (3 miles) per               1            2  .............  .............  .............  1............  4............  ................
 hour.                                                                                                                                                  
Sampling and readings............  ...........  ...........  .............  2............  2............  2............  2............  ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 2 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.                                                                     
\2\ Treadmill shall be inclined 15 deg. from vertical and operated at a speed of 1 foot per second.                                                     


                                                                                                                                                        
[[Page 30369]]
                                      Table 3.--Duration and Sequence of Specific Activities For Test 3, in Minutes                                     
                                                               [42 CFR part 84, subpart H]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Service time--                                                  
                                     -------------------------------------------------------------------------------------------------------------------
              Activity                                                                                                                        2, 3 and 4
                                       3 minutes     5 minutes      10 minutes     15 minutes     30 minutes     45 minutes       1 hour      hours \1\ 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings...............  ...........  .............  .............  2............  2............  2............  2............        (\2\)
Walks at 4.8 km. (3 miles) per hour.  ...........  .............  1............  1............  2............  2............  3............  ...........
Runs at 9.7 km. (6 miles) per hour..            1  1............  1............  1............  1............  1............  1............  ...........
Pulls 20 kg. (45 pound) weight to 5   ...........  15 times in 1  .............  30 times in 2  30 times in 2  30 times in 2  60 times in 6  ...........
 feet.                                              minute.                       minutes.       minutes.       minutes.       minutes.                 
Lies on side........................          1/2  1............  1............  2............  3............  4............  5............  ...........
Lies on back........................          1/2  1............  1............  2............  2............  3............  3............  ...........
Crawls on hands and knees...........            1  1............  1............  2............  2............  2............  2............  ...........
Sampling and readings...............  ...........  .............  2............  .............  2............  2............  2............  ...........
Runs at 9.7 km. (6 miles) per hour..  ...........  .............  .............  1............  1............  1............  1............  ...........
Walks at 4.8 km. (3 miles) per hour.  ...........  .............  .............  .............  2............  8............  10...........  ...........
Pulls 20 kg. (45 pound) weight to 5   ...........  .............  30 times in 2  .............  60 times in 6  60 times in 6  60 times in 6  ...........
 feet.                                                             minutes.                      minutes.       minutes.       minutes.                 
Sampling and readings...............  ...........  .............  .............  2............  .............  2............  2............  ...........
Walks at 4.8 km. (3 miles) per hour.  ...........  .............  1............  .............  3............  4............  10...........  ...........
Lies on side........................  ...........  .............  .............  .............  .............  2............  4............  ...........
Lies on back........................  ...........  .............  .............  .............  .............  2............  1............  ...........
Sampling and readings...............  ...........  .............  .............  .............  2............  2............  2............  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 3 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.                                                                     
\2\ Perform test No. 3 for 1 hr. apparatus; then perform test No. 1 for 1 hour apparatus.                                                               


                                                                                                                                                        
[[Page 30370]]
                                                          Table 4.--Duration and Sequence of Specific Activities for Test 4, in Minutes                                                         
                                                                                   [42 CFR part 84, subpart H]                                                                                  
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Service time--                                                             
                       Activity                        -----------------------------------------------------------------------------------------------------------------------------------------
                                                          3 minutes      5 minutes      10 minutes     15 minutes     30 minutes     45 minutes       1 hour      2 hours    3 hours    4 hours 
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings.................................  .............  .............  .............  2............  2............  2............  2............      (\2\)      (\3\)      (\4\)
Walks at 4.8 km. (3 miles) per hour...................  .............  .............  .............  1............  2............  2............  2............  .........  .........  .........
Climbs vertical treadmill \1\ (or equivalent).........  1............  1............  1............  1............  1............  1............  1............  .........  .........  .........
Walks at 4.8 km. (3 miles) per hour...................  .............  1............  1............  1............  2............  2............  2              .........  .........  .........
Pulls 20 kg. (45 pound) weight to 5 feet..............  .............  30 times in 2  30 times in 2  30 times in 2  60 times in 5  60 times in 5  60 times in 5  .........  .........  .........
                                                                        minutes.       minutes.       minutes.       minutes.       minutes.       minutes.                                     
Walks at 4.8 km. (3 miles) per hour...................  .............  .............  1............  1............  1............  2............  3............  .........  .........  .........
Carries 23 kg. (50 pound) weight over overcast........  .............  .............  .............  1 time in 1    1 time in 1    2 times in 3   4 times in 8   .........  .........  .........
                                                                                                      minute.        minute.        minutes.       minutes.                                     
Sampling and readings.................................  .............  .............  2............  .............  2............  2............  2............  .........  .........  .........
Walks at 4.8 km. (3 miles) per hour...................  .............  .............  .............  1............  3............  3............  4............  .........  .........  .........
Runs at 9.7 km. (6 miles) per hour....................  .............  1............  1............  1............  1............  1............  1............  .........  .........  .........
Carries 23 kg. (50 pound) weight over overcast........  .............  .............  1 time in 1    1 time in 1    2 times in 3   4 times in 6   6 times in 9   .........  .........  .........
                                                                                       minute.        minute.        minutes.       minutes.       minutes.                                     
Pulls 20 kg (45 pound) weight to 5 feet...............  15 times in 1  .............  .............  15 times in 1  60 times in 5  30 times in 2  36 times in 3  .........  .........  .........
                                                         minute.                                      minute.        minutes.       minutes.       minutes.                                     
Sampling and readings.................................  .............  .............  .............  2............  2............  2............  2............  .........  .........  .........
Walks at 4.8 km. (3 miles) per hour...................  1............  .............  1............  .............  .............  2............  6............  .........  .........           
Pulls 20 kg. (45 pound) weight to 5 feet..............  .............  .............  .............  .............  .............  60 times in 5  60 times in 5  .........  .........  .........
                                                                                                                                    minutes.       minutes.                                     
Carries 20 kg. (45 pound) weight and walks at 4.8 km.   .............  .............  .............  .............  .............  3............  3............  .........  .........  .........
 (3 miles) per hour.                                                                                                                                                                            
Sampling and readings.................................  .............  .............  .............  .............  .............  2............  2............  .........  .........  .........
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Treadmill shall be inclined 15 deg. from vertical and operated at a speed of 30 cm. (1 foot) per second.                                                                                    
\2\ Perform test No. 1 for 30-minute apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 30-minute apparatus.                                                  
\3\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus.                                                        
\4\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus twice (i.e., two one-hour tests).                       


[[Page 30371]]

Subpart I--Gas Masks


Sec. 84.110  Gas masks; description.

    (a) Gas masks including all completely assembled air purifying 
masks designed for use as respiratory protection during entry into 
atmospheres not immediately dangerous to life or health or escape only 
from hazardous atmospheres containing adequate oxygen to support life 
are described as follows:
    (1) Front-mounted or back-mounted gas mask. A gas mask which 
consists of a full facepiece, a breathing tube, a canister at the front 
or back, a canister harness, and associated connections.
    (2) Chin-style gas mask. A gas mask which consists of a full 
facepiece, a canister which is usually attached to the facepiece, and 
associated connections.
    (3) Escape gas mask. A gas mask designed for use during escape only 
from hazardous atmospheres which consists of a facepiece or mouthpiece, 
a canister, and associated connections.
    (b) Gas masks shall be further described according to the types of 
gases or vapors against which they are designed to provide respiratory 
protection, as follows:

                                                                        
                                                                        
Type of front-mounted or back-mounted gas mask:                         
  Acid gas <SUP>1 <SUP>2 <SUP>3                                                        
  Ammonia                                                               
  Carbon monoxide                                                       
  Organic Vapor <SUP>1 <SUP>2 <SUP>3                                                   
  Other gas(es) and vapor(s) <SUP>1 <SUP>2 <SUP>3                                      
  Combination of two or more of the above gases and vapors.<SUP>1 <SUP>2 <SUP>3        
  Combination of acid gas, ammonia, carbon monoxide, and organic        
   vapors.<SUP>1 <SUP>2 <SUP>3                                                         
Type of chin-style gas mask:                                            
  Acid gas <SUP>1 <SUP>2 <SUP>3                                                        
  Ammonia                                                               
  Carbon monoxide                                                       
  Organic vapor <SUP>1 <SUP>2 <SUP>3                                                   
  Other gas(es) and vapor <SUP>1 <SUP>2 <SUP>3                                         
  Combination of two or more of the above gases and vapors.<SUP>1 <SUP>2 <SUP>3        
Type of escape gas mask:                                                
  Acid gas <SUP>1 <SUP>2 <SUP>3 <SUP>4                                                      
  Ammonia \4\                                                           
  Carbon monoxide                                                       
  Organic vapor <SUP>1 <SUP>2 <SUP>3 <SUP>4                                                 
  Other gas(s) and vapor(s) <SUP>1 <SUP>2 <SUP>3 <SUP>4                                     
  Combination of two or more of the above gases and vapors. <SUP>1 <SUP>2 <SUP>3 <SUP>4     
\1\ Approval may be for acid gases or organic vapors as a class or for  
  specific acid gases or organic vapors.                                
\2\ Not for use against gases or vapors with poor warning properties    
  (except where MSHA or Occupational Safety and Health Administration   
  standards permit such use for a specific gas or vapor), or those which
  generate high heats or reaction with sorbent materials in the         
  canister.                                                             
\3\ Use of the gas mask may be limited by factors such as lower         
  explosive limit, toxicological effects, and facepiece fit. Limitations
  on gas mask service life and sorbent capacity limitations shall be    
  specified by the applicant in instructions for selection, use and     
  maintenance of the gas mask.                                          
\4\ Eye protection may be required in certain concentrations of gases   
  and vapors.                                                           

    (c) Gas masks for respiratory protection against gases and vapors 
other than those specified in paragraph (b) of this section, may be 
approved upon submittal of an application in writing for approval to 
the Certification and Quality Assurance Branch listing the gas or vapor 
and suggested maximum use concentration for the specific type of gas 
mask. The Institute will consider the application and accept or reject 
it on the basis of effect on the wearer's health and safety and any 
field experience in use of gas masks for such exposures. If the 
application is accepted, the Institute will test such masks in 
accordance with the requirements of this subpart.


Sec. 84.111  Gas masks; required components.

    (a) Each gas mask described in Sec. 84.110 shall, where its design 
requires, contain the following component parts:
    (1) Facepiece or mouthpiece and noseclip;
    (2) Canister or cartridge;
    (3) Canister harness;
    (4) External check valve; and
    (5) Breathing tube.
    (b) The components of each gas mask shall meet the minimum 
construction requirements set forth in subpart G of this part.


Sec. 84.112  Canisters and cartridges in parallel; resistance 
requirements.

    Where two or more canisters or cartridges are used in parallel, 
their resistance to airflow shall be essentially equal.


Sec. 84.113  Canisters and cartridges; color and markings; 
requirements.

    The color and markings of all canisters and cartridges or labels 
shall conform with the requirements of the American National Standards 
Institute, American National Standard for Identification of Air-
Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI 
K13.1 is incorporated by reference and has been approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. Copies may be obtained from American National Standards 
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be 
inspected at the NIOSH, Certification and Quality Assurance Branch, 
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.


Sec. 84.114  Filters used with canisters and cartridges; location; 
replacement.

    (a) Particulate matter filters used in conjunction with a canister 
or cartridge shall be located on the inlet side of the canister or 
cartridge.
    (b) Filters shall be incorporated in or firmly attached to the 
canister or cartridge and each filter assembly shall, where applicable, 
be designed to permit its easy removal from and replacement in the 
canister or cartridge.


Sec. 84.115  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with gas masks shall 
be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces or mouthpieces;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm 
pressure.


Sec. 84.116  Harnesses; installation and construction; minimum 
requirements.

    (a) Each gas mask shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
gas mask in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of gas mask parts, and where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.


Sec. 84.117  Gas mask containers; minimum requirements.

    (a) Gas masks shall be equipped with a substantial, durable 
container bearing markings which show the applicant's name, the type 
and commercial designation of mask it contains and all appropriate 
approval labels.
    (b) Containers for gas masks shall be designed and constructed to 
permit easy removal of the mask.


Sec. 84.118  Half-mask facepieces, full facepieces, and mouthpieces; 
fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for optional use of corrective 
spectacles or [[Page 30372]] lenses, which shall not reduce the 
respiratory protective qualities of the gas mask.
    (c) Half-mask facepieces shall not interfere with the fit of common 
industrial safety spectacles, as determined by the Institute's 
facepiece tests in Sec. 84.124.
    (d) Gas masks with mouthpieces shall be equipped with noseclips 
which are securely attached to the mouthpiece or gas mask and provide 
an airtight seal.
    (e) Facepieces shall be designed to prevent eyepiece fogging.


Sec. 84.119  Facepieces; eyepieces; minimum requirements.

    (a) Full facepieces shall be designed and constructed to provide 
adequate vision which is not distorted by the eye.
    (b) All eyepieces shall be designed and constructed to be impact 
and penetration resistant. Federal Specification, Mask, Air Line: and 
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 
with interim amendment-1, July 30, 1969, is an example of an 
appropriate standard for determining impact and penetration resistance. 
Copies of GGG-M-125d may be obtained from the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.


Sec. 84.120  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against damage and distortion.
    (b) Inhalation valves shall be designed and constructed to prevent 
excessive exhaled air from adversely affecting cartridges, canisters, 
and filters.
    (c) Exhalation valves shall be protected against external 
influence, and designed and constructed to prevent inward leakage of 
contaminated air.


Sec. 84.121  Head harnesses; minimum requirements.

    (a) Facepieces shall be equipped with adjustable and replaceable 
head harnesses, designed and constructed to provide adequate tension 
during use and an even distribution of pressure over the entire area in 
contact with the face.
    (b) Mouthpieces shall be equipped, where applicable, with 
adjustable and replaceable harnesses designed and constructed to hold 
the mouthpiece in place.


Sec. 84.122  Breathing resistance test; minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece or 
mouthpiece of a gas mask mounted on a breathing machine both before and 
after each test conducted in accordance with Secs. 84.124, 84.125, and 
84.126, with air flowing at a continuous rate of 85 liters per minute.
    (b) The maximum allowable resistance requirements for gas masks are 
as follows:

                           Maximum Resistance                           
                        [mm. water-column height]                       
------------------------------------------------------------------------
                                          Inhalation                    
         Type of gas mask         --------------------------  Exhalation
                                     Initial     Final \1\              
------------------------------------------------------------------------
Front-mounted or back-mounted                                           
 (without particulate filter)....           60           75           20
Front-mounted or back-mounted                                           
 (with approved particulate                                             
 filter).........................           70           85           20
Chin-style (without particulate                                         
 filter).........................           40           55           20
Chin-style (with approved                                               
 particulate filter).............           65           80           20
Escape (without particulate                                             
 filter).........................           60           75           20
Escape (with approved particulate                                       
 filter).........................           70           85           20
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Tables 5, 6, and 7 
  of this subpart.                                                      

Sec. 84.123  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.


Sec. 84.124  Facepiece tests; minimum requirements.

    (a) The complete gas mask will be fitted to the faces of persons 
having varying facial shapes and sizes.
    (b) Where the applicant specifies a facepiece size or sizes for the 
gas mask, together with the approximate measurements of faces they are 
designed to fit, the Institute will insure that test subjects suit such 
facial measurements.
    (c) Any gas mask parts which must be removed to perform the 
facepiece or mouthpiece fit test shall be replaceable without special 
tools and without disturbing the facepiece or mouthpiece fit.
    (d) The facepiece or mouthpiece fit test, using positive or 
negative pressure recommended by the applicant and described in his 
instructions will be used before each test specified in paragraph (e) 
of this section, and in Sec. 84.125.
    (e)(1) Each wearer will enter a chamber containing 100 p.p.m. 
isoamyl acetate vapor for a half-mask facepiece and 1,000 p.p.m. 
isoamyl acetate vapor for a full facepiece or mouthpiece.
    (2) The facepiece or mouthpiece may be adjusted, if necessary, in 
the test chamber before starting the tests.
    (3) Each wearer will remain in the chamber for 8 minutes while 
performing the following activities:
    (i) Two minutes, nodding and turning head;
    (ii) Two minutes, calisthenic arm movements;
    (iii) Two minutes, running in place; and
    (iv) Two minutes, pumping with a tire pump into a 28 liter (1 cubic 
foot) container.
    (4) Each wearer shall not detect the odor of isoamyl acetate during 
the test.


Sec. 84.125  Particulate tests; canisters containing particulate 
filters; minimum requirements.

    Gas mask canisters containing filters for protection against 
particulates (e.g. dusts, fumes, mists, and smokes) in combination with 
gases, vapors, or gases and vapors, shall also comply with the 
requirements as prescribed in Secs. 84.170 through 84.183, except for 
the airflow resistance test of Sec. 84.181.


Sec. 84.126  Canister bench tests; minimum requirements.

    (a)(1) Bench tests, except for carbon monoxide tests, will be made 
on an apparatus that allows the test atmosphere at 50<plus-minus>5 
percent relative humidity and room temperature (25<plus-minus>2.5 
deg.C.) to enter the canister continuously at concentrations and rates 
of flow [[Page 30373]] specified in Tables 5, 6, and 7 of this subpart.
    (2) Three canisters will be removed from containers and tested as 
received from the applicant.
    (3) Two canisters, other than those described in paragraph (a)(2) 
of this section, will be equilibrated at room temperature by passing 25 
percent relative humidity air through them at 64 liters per minute for 
6 hours.
    (4) Two canisters, other than those described in paragraphs (a) (2) 
and (3) of this section, will be equilibrated at room temperature by 
passing 85 percent relative humidity air through them at 64 liters per 
minute for 6 hours.
    (5) The equilibrated canisters will be resealed, kept in an upright 
position at room temperature, and tested within 18 hours.
    (b) Front-mounted and back-mounted gas mask canisters will be 
tested and shall meet the minimum requirements set forth in Table 5 of 
this subpart.
    (c)(1) Front-mounted, and back-mounted, and chin-style canisters 
designated as providing respiratory protection against gases, ammonia, 
organic vapors, carbon monoxide and particulate contaminants shall have 
a window or other indicator to warn the gas mask wearer when the 
canister will no longer satisfactorily remove carbon monoxide from the 
inhaled air.
    (2) Other types of front- and back-mounted canisters may also be 
equipped with a window or other indicator to warn of imminent leakage 
of other gases or vapors.
    (3) The window indicator canisters will be tested as regular 
canisters, but shall show a satisfactory indicator change or other 
warning before the allowable canister penetration has occurred.
    (d) Chin-style gas mask canisters shall meet the minimum 
requirements set forth in Table 6 of this subpart.
    (e) Escape gas mask canisters shall meet the minimum requirements 
set forth in Table 7 of this subpart.

Tables to Subpart I of Part 84

                          Table 5.--Canister Bench Tests and Requirements for Front-Mounted and Back-Mounted Gas Mask Canisters                         
                                                               [42 CFR part 84, subpart I]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Test atmosphere                                                
                                                                            ----------------------------------------              Maximum               
                                                                                                          Flow rate  Number of   allowable     Minimum  
                    Canister type                         Test condition                   Concentration   (liters     tests    penetratin  service life
                                                                             Gas or vapor    (parts per      per                (parts per    (minutes) 
                                                                                              million)     minute)               million)        \1\    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas.............................................  As received           SO<INF>2                 20,000          64          3           5           12 
                                                       Equilibrated          Cl<INF>2                 20,000          64          3           5           12 
                                                       ....................  SO<INF>2                 20,000          32          4           5           12 
                                                       ....................  Cl<INF>2                 20,000          32          4           5           12 
Organic vapor........................................  As received           CCl<INF>4                20,000          64          3           5           12 
                                                       Equilibrated          CCl<INF>4                20,000          32          4           5           12 
Ammonia..............................................  As received           NH<INF>3                 30,000          64          3          50           12 
                                                       Equilibrated          NH<INF>3                 30,000          32          4          50           12 
Carbon monoxide......................................  As received           CO                  20,000      \4\ 64          2       (\3\)           60 
                                                       Equilibrated          CO                   5,000      \2\ 32          3       (\3\)           60 
                                                       ....................  CO                   3,000      \2\ 32          3       (\3\)           60 
Combination of 2 or 3 of above types \5\                                                                                                                
Combination of all above types \6\                                                                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.                                                                                       
\2\ Relative humidity of test atmosphere will be 95<plus-minus>3pct; temperature of test atmosphere will be 25<plus-minus>2.5 deg. C.                   
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.             
\4\ Relative humidity of test atmosphere will be 95<plus-minus>3pct; temperature of test atmosphere entering the test fixture will be 0<plus-minus>2.5  
  deg.C-0 deg.C.                                                                                                                                        
\5\ Test conditions and requirements will be applicable as shown in this table.                                                                         
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and       
  ammonia will be 6 min instead of 12 min.                                                                                                              


                                    Table 6--Canister Bench Tests and Requirements for Chin-Style Gas Mask Canisters                                    
                                                               [42 CFR part 84, subpart I]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Test atmosphere                                                 
                                                                           ----------------------------------------              Maximum                
                                                                                                         Flow rate  Number of   allowable      Minimum  
                    Canister type                        Test condition                   Concentration   (liters     tests    penetration  service life
                                                                            Gas or vapor    (parts per      per                 (parts per    (minutes) 
                                                                                             million)     minute)                million)        \1\    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................................  As received           SO<INF>2                 50,000          64          3           5            12 
                                                       Equilibrated                                                                                     
                                                      ....................  Cl<INF>2                  5,000          64          3           5            12 
                                                      ....................  SO<INF>2                  5,000          32          4           5            12 
                                                      ....................  Cl<INF>2                  5,000          32          4           5            12 
Organic vapor.......................................  As received           CCl<INF>4                 5,000          64          3           5            12 
                                                       Equilibrated                                                                                     
                                                      ....................  CCl<INF>4                 5,000          32          4           5            12 
Ammonia.............................................  As received           NH<INF>3                  5,000          64          3          50            12 
                                                       Equilibrated                                                                                     
                                                      As received           NH<INF>3                  5,000          32          4          50            12 
                                                       Equilibrated                                                                                     
Carbon monoxide.....................................  As received           CO                  20,000      \2\ 64          2       (\3\)            60 
                                                      ....................  CO                   5,000      \4\ 32          3       (\3\)            60 
[[Page 30374]]
                                                                                                                                                        
                                                      ....................  CO                   3,000      \2\ 32          3       (\3\)            60 
Combination of 2 or 3 of above types \5\                                                                                                                
Combination of all above types \6\                                                                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.                                                                                       
\2\ Relative humidity of test atmosphere will be 95 <plus-minus> 3pct; temperature of test atmosphere will be 25 <plus-minus> 2.5 deg. C.               
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.             
\4\ Relative humidity of test atmosphere will be 95 <plus-minus> 3pct; temperature of test atmosphere entering the test fixture will be 0 <plus-minus>  
  2.5 deg. C-0 deg. C.                                                                                                                                  
\5\ Test conditions and requirements will be applicable as shown in this table.                                                                         
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and       
  ammonia will be 6 min instead of 12 min.                                                                                                              


                                      Table 7.--Canister Bench Tests and Requirements for Escape Gas Mask Canisters                                     
                                                               [42 CFR part 84, subpart I]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Test atmosphere                                                 
                                                                           ----------------------------------------              Maximum                
                                                                                                         Flow rate  Number of   allowable      Minimum  
                    Canister type                        Test condition                   Concentration   (liters     tests    penetration  service life
                                                                            Gas or vapor    (parts per      per                 (parts per    (minutes) 
                                                                                             million)     minute)                million)        \1\    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................................  As received.........  SO<INF>2                  5,000          64          3           5            12 
                                                      Equilibrated........  Cl<INF>2                  5,000          64          3           5            12 
                                                                            SO<INF>2                  5,000          32          4           5            12 
                                                                            Cl<INF>2                  5,000          32          4           5            12 
Organic vapor.......................................  As received.........  CCl<INF>4                 5,000          64          3           5            12 
                                                      Equilibrated........  CCl<INF>4                 5,000          32          4           5            12 
Ammonia.............................................  As received.........  NH<INF>3                  5,000          64          3          50            12 
                                                      Equilibrated........  NH<INF>3                  5,000          32          4          50            12 
Carbon monoxide.....................................  As received.........  CO                  10,000      \2\ 32          2       (\3\)        \4\ 60 
                                                                            CO                   5,000      \5\ 32          3       (\3\)            60 
                                                                            CO                   3,000      \2\ 32          3       (\3\)            60 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.                                                                                       
\2\ Relative humidity of test atmosphere will be 95<plus-minus>3pct; temperature of test atmosphere will be 25<plus-minus>2.5 deg. C.                   
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.             
\4\ If effluent temperature exceeds 100 deg. C during this test, the escape gas mask shall be equipped with an effective heat exchanger.                
\5\ Relative humidity of test atmosphere will be 95<plus-minus>3 pct; temperature of test atmosphere entering the test fixture will be 0<plus-minus>2.5 
  deg. C--0 deg. C.                                                                                                                                     

Subpart J--Supplied-Air Respirators


Sec. 84.130  Supplied-air respirators; description.

    Supplied-air respirators, including all completely assembled 
respirators designed for use as respiratory protection during entry 
into and escape from atmospheres not immediately dangerous to life or 
health are described as follows:
    (a) Type ``A'' supplied-air respirators. A hose mask respirator, 
for entry into and escape from atmospheres not immediately dangerous to 
life or health, which consists of a motor-driven or hand-operated 
blower that permits the free entrance of air when the blower is not 
operating, a strong large-diameter hose having a low resistance to 
airflow, a harness to which the hose and the life-line are attached and 
a tight-fitting facepiece.
    (b) Type ``AE'' supplied-air respirators. A Type ``A'' supplied-air 
respirator equipped with additional devices designed to protect the 
wearer's head and neck against impact and abrasion from rebounding 
abrasive material, and with shielding material such as plastic, glass, 
woven wire, sheet metal, or other suitable material to protect the 
window(s) of facepieces, hoods, and helmets which do not unduly 
interfere with the wearer's vision and permit easy access to the 
external surface of such window(s) for cleaning.
    (c) Type ``B'' supplied-air respirators. A hose mask respirator, 
for entry into and escape from atmospheres not immediately dangerous to 
life or health, which consists of a strong large-diameter hose with low 
resistance to airflow through which the user draws inspired air by 
means of his lungs alone, a harness to which the hose is attached, and 
a tight-fitting facepiece.
    (d) Type ``BE'' supplied-air respirators. A type ``B'' supplied-air 
respirator equipped with additional devices designed to protect the 
wearer's head and neck against impact and abrasion from rebounding 
abrasive material, and with shielding material such as plastic, glass, 
woven wire, sheet metal, or other suitable material to protect the 
window(s) of facepieces, hoods, and helmets which do not unduly 
interfere with the wearer's vision and permit easy access to the 
external surface of such window(s) for cleaning.
    (e) Type ``C'' supplied-air respirators. An airline respirator, for 
entry into and escape from atmospheres not immediately dangerous to 
life or health, which consists of a source of respirable breathing air, 
a hose, a detachable coupling, a control valve, orifice, a 
[[Page 30375]] demand valve or pressure demand valve, an arrangement 
for attaching the hose to the wearer, and a facepiece, hood, or helmet.
    (f) Type ``CE'' supplied-air respirators. A type ``C'' supplied-air 
respirator equipped with additional devices designed to protect the 
wearer's head and neck against impact and abrasion from rebounding 
abrasive material, and with shielding material such as plastic, glass, 
woven wire, sheet metal, or other suitable material to protect the 
window(s) of facepieces, hoods, and helmets which do not unduly 
interfere with the wearer's vision and permit easy access to the 
external surface of such window(s) for cleaning.


Sec. 84.131  Supplied-air respirators; required components.

    (a) Each supplied-air respirator described in Sec. 84.130 shall, 
where its design requires, contain the following component parts:
    (1) Facepiece, hood, or helmet;
    (2) Air supply valve, orifice, or demand or pressure-demand 
regulator;
    (3) Hand operated or motor driven air blower;
    (4) Air supply hose;
    (5) Detachable couplings;
    (6) Flexible breathing tube; and
    (7) Respirator harness.
    (b) The component parts of each supplied-air respirator shall meet 
the minimum construction requirements set forth in subpart G of this 
part.
Sec. 84.132  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with supplied-air 
respirators shall be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm 
pressure.


Sec. 84.133  Harnesses; installation and construction; minimum 
requirements.

    (a) Each supplied-air respirator shall, where necessary, be 
equipped with a suitable harness designed and constructed to hold the 
components of the respirator in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of respirator parts, and where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.


Sec. 84.134  Respirator containers; minimum requirements.

    Supplied-air respirators shall be equipped with a substantial, 
durable container bearing markings which show the applicant's name, the 
type and commercial designation of the respirator it contains, and all 
appropriate approval labels.


Sec. 84.135  Half-mask facepieces, full facepieces, hoods, and helmets; 
fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for optional use of corrective 
spectacles or lenses, which shall not reduce the respiratory protective 
qualities of the respirator.
    (c) Hoods and helmets shall be designed and constructed to fit 
persons with various head sizes, provide for the optional use of 
corrective spectacles or lenses, and insure against any restriction of 
movement by the wearer.
    (d) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.


Sec. 84.136  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.

    (a) Facepieces, hoods, and helmets shall be designed and 
constructed to provide adequate vision which is not distorted by the 
eyepiece.
    (b) All eyepieces except those on Types B, BE, C, and CE supplied-
air respirators shall be designed and constructed to be impact and 
penetration resistant. Federal Specification, Mask, Air Line: and 
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 
with interim amendment-1, July 30, 1969, is an example of an 
appropriate standard for determining impact and penetration resistance. 
Copies of GGG-M-125d may be obtained from the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
    (c)(1) The eyepieces of AE, BE, and CE type supplied-air 
respirators shall be shielded by plastic, glass, woven wire, sheet 
metal, or other suitable material which does not interfere with the 
vision of the wearer.
    (2) Shields shall be mounted and attached to the facepiece to 
provide easy access to the external surface of the eyepiece for 
cleaning.


Sec. 84.137  Inhalation and exhalation valves; check valves; minimum 
requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against distortion.
    (b) Exhalation valves shall be:
    (1) Protected against damage and external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.
    (c) Check valves designed and constructed to allow airflow toward 
the facepiece only shall be provided in the connections to the 
facepiece or in the hose fitting near the facepiece of all Type A, AE, 
B, and BE supplied-air respirators.


Sec. 84.138  Head harnesses; minimum requirements.

    Facepieces shall be equipped with adjustable and replaceable head 
harnesses which are designed and constructed to provide adequate 
tension during use, and an even distribution of pressure over the 
entire area in contact with the face.


Sec. 84.139  Head and neck protection; supplied-air respirators; 
minimum requirements.

    Type AE, BE, and CE supplied-air respirators shall be designed and 
constructed to provide protection against impact and abrasion from 
rebounding abrasive materials to the wearer's head and neck.
Sec. 84.140  Air velocity and noise levels; hoods and helmets; minimum 
requirements.

    Noise levels generated by the respirator will be measured inside 
the hood or helmet at maximum airflow obtainable within pressure and 
hose length requirements and shall not exceed 80 dBA.


Sec. 84.141  Breathing gas; minimum requirements.

    (a) Breathing gas used to supply supplied-air respirators shall be 
respirable breathing air and contain no less than 19.5 volume-percent 
of oxygen.
    (b) Compressed, gaseous breathing air shall meet the applicable 
minimum grade requirements for Type I gaseous air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade D or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from 
American National Standards Institute, Inc., 1430 Broadway, New York, 
NY 10018. Copies may be [[Page 30376]] inspected at the NIOSH, 
Certification and Quality Assurance Branch, 1095 Willowdale Road, 
Morgantown, WV 26505-2888, or at the Office of the Federal Register, 
800 North Capitol Street, NW., suite 700, Washington, DC.
    (c) Compressed, liquefied breathing air shall meet the applicable 
minimum grade requirements for Type II liquid air set forth in the 
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 
(Grade B or higher quality). G-7.1 is incorporated by reference and has 
been approved by the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from 
American National Standards Institute, Inc., 1430 Broadway, New York, 
NY 10018. Copies may be inspected at the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888, or at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.


Sec. 84.142  Air supply source; hand-operated or motor driven air 
blowers; Type A supplied-air respirators; minimum requirements.

    (a) Blowers shall be designed and constructed to deliver an 
adequate amount of air to the wearer with either direction of rotation, 
unless constructed to permit rotation in one direction only, and to 
permit the free entrance of air to the hose when the blower is not 
operated.
    (b) No multiple systems, whereby more than one user is supplied by 
one blower, will be approved, unless each hose line is connected 
directly to a manifold at the blower.


Sec. 84.143  Terminal fittings or chambers; Type B supplied-air 
respirators; minimum requirements.

    (a) Blowers or connections to air supplies providing positive 
pressures shall not be approved for use on Type B supplied-air 
respirators.
    (b) Terminal fittings or chambers employed in Type B supplied-air 
respirators, shall be:
    (1) Installed in the inlet of the hose.
    (2) Designed and constructed to provide for the drawing of air 
through corrosion resistant material arranged so as to be capable of 
removing material larger than 0.149 mm. in diameter (149 micrometers, 
100-mesh, U.S. Standard sieve).
    (3) Installed to provide a means for fastening or anchoring the 
fitting or chamber in a fixed position in a zone of respirable air.


Sec. 84.144  Hand-operated blower test; minimum requirements.

    (a) Hand-operated blowers shall be tested by attaching them to a 
mechanical drive and operating them 6 to 8 hours daily for a period of 
100 hours at a speed necessary to deliver 50 liters of air per minute 
through each completely assembled respirator. Each respirator shall be 
equipped with the maximum length of hose with which the device is to be 
approved and the hose shall be connected to each blower or manifold 
outlet designed for hose connections.
    (b) The crank speed of the hand-operated blower shall not exceed 50 
revolutions per minute in order to deliver the required 50 liters of 
air per minute to each facepiece.
    (c) The power required to deliver 50 liters of air per minute to 
each wearer through the maximum length of hose shall not exceed one-
fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. 
(5 pounds) on a 20 cm. (8-inch) crank, as defined in Sec. 84.146.
    (d) The blower shall operate throughout the period without failure 
or indication of excessive wear of bearings or other working parts.


Sec. 84.145  Motor-operated blower test; minimum requirements.

    (a) Motor-operated blowers shall be tested by operating them at 
their specified running speed 6 to 8 hours daily for a period of 100 
hours when assembled with the kind and maximum length of hose for which 
the device is to be approved and when connected to each blower or 
manifold outlet designed for hose connections.
    (b) The connection between the motor and the blower shall be so 
constructed that the motor may be disengaged from the blower when the 
blower is operated by hand.
    (c) The blower shall operate throughout the period without failure 
or indication of excessive wear of bearings or other working parts.
    (d) Where a blower, which is ordinarily motor driven, is operated 
by hand, the power required to deliver 50 liters of air per minute to 
each wearer through the maximum length of hose shall not exceed one-
fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg. 
(5 pounds) on a 20 cm. (8-inch) crank, as defined in Sec. 84.146.
    (e) Where the respirator is assembled with the facepiece and 15 m. 
(50 feet) of the hose for which it is to be approved, and when 
connected to one outlet with all other outlets closed and operated at a 
speed not exceeding 50 revolutions of the crank per minute, the amount 
of air delivered into the respiratory-inlet covering shall not exceed 
150 liters per minute.
Sec. 84.146  Method of measuring the power and torque required to 
operate blowers.

    As shown in Figure 1 of this section, the blower crank is replaced 
by a wooden drum, a (13 cm. (5 inches) in diameter is convenient). This 
drum is wound with about 12 m. (40 feet) of No. 2 picture cord, b. A 
weight, c, of sufficient mass to rotate the blower at the desired speed 
is suspended from this wire cord. A mark is made on the cord about 3 to 
4.5 m. (10 to 15 feet) from the weight, c. Another mark is placed at a 
measured distance (6-9 m./20-30 feet is convenient) from the first. 
These are used to facilitate timing. To determine the torque or 
horsepower required to operate the blower, the drum is started in 
rotation manually at or slightly above the speed at which the power 
measurement is to be made. The blower is then permitted to assume 
constant speed, and then as the first mark on the wire leaves the drum, 
a stopwatch is started. The watch is stopped when the second mark 
leaves the drum. From these data the foot-pounds per minute and the 
torque may be calculated.

BILLING CODE 4160-19-P

[[Page 30377]]

Figure 1--Apparatus for measuring power required to operate blower. 
(42 CFR part 84, subpart J, Sec. 84.146)
[GRAPHIC][TIFF OMITTED]TR08JN95.000


BILLING CODE 4160-19-C
Sec. 84.147  Type B supplied-air respirator; minimum requirements.

    No Type B supplied-air respirator shall be approved for use with a 
blower or with connection to an air supply device at positive 
pressures.


Sec. 84.148  Type C supplied-air respirator, continuous flow class; 
minimum requirements.

    (a) Respirators tested under this section shall be approved only 
when they supply respirable air at the pressures and quantities 
required.
    (b) The pressure at the inlet of the hose connection shall not 
exceed 863 kN/m.\2\ (125 pounds per square inch gage).
    (c) Where the pressure at any point in the supply system exceeds 
863 kN/m.\2\ (125 pounds per square inch gage), the respirator shall be 
equipped with a pressure-release mechanism that will prevent the 
pressure at the hose connection from exceeding 863 kN/m.\2\ (125 pounds 
per square inch gage) under any conditions.


Sec. 84.149  Type C supplied-air respirator, demand and pressure demand 
class; minimum requirements.

    (a) Respirators tested under this section shall be approved only 
when used to supply respirable air at the pressures and quantities 
required.
    (b) The manufacturer shall specify the range of air pressure at the 
point of attachment of the air-supply hose to the air-supply system, 
and the range of hose length for the respirator. For example, he might 
specify that the respirator be used with compressed air at pressures 
ranging from 280-550 kN/m.\2\ (40 to 80 pounds per square inch) with 
from 6 to 76 m. (15 to 250 feet) of air-supply hose.
    (c) The specified air pressure at the point of attachment of the 
hose to the air-supply system shall not exceed 863 kN/m.\2\ (125 pounds 
per square inch gage).
    (d)(1) Where the pressure in the air-supply system exceeds 863 kN/
m.\2\ (125 pounds per square inch gage), the respirator shall be 
equipped with a pressure-release mechanism that will prevent the 
pressure at the point of attachment of the hose to the air-supply 
system from exceeding 863 kN/m.\2\ (125 pounds per square inch gage).
    (2) The pressure-release mechanism shall be set to operate at a 
pressure not more than 20 percent above the manufacturer's highest 
specified pressure. For example, if the highest specified pressure is 
863 kN/m.\2\ (125 pounds per square inch), the pressure-release 
mechanism would be set to operate at a maximum of 1,035 kN/m.\2\ (150 
pounds per square inch).


Sec. 84.150  Air-supply line tests; minimum requirements.

    Air supply lines employed on Type A, Type B, and Type C supplied-
air respirators shall meet the minimum test requirements set forth in 
Table 8 of this subpart.


Sec. 84.151  Harness test; minimum requirements.

    (a)(1) Shoulder straps employed on Type A supplied-air respirators 
shall be tested for strength of material, joints, and seams and must 
separately withstand a pull of 113 kg. (250 pounds) for 30 minutes 
without failure.
    (2) Belts, rings, and attachments for life lines must withstand a 
pull of 136 kg. (300 pounds) for 30 minutes without failure.
    (3) The hose shall be firmly attached to the harness so as to 
withstand a pull of 113 kg. (250 pounds) for 30 minutes without 
separating, and the hose attachments shall be arranged so that the pull 
or drag of the hose behind an advancing wearer does not disarrange the 
harness or exert pull upon the facepiece.
    (4) The arrangement and suitability of all harness accessories and 
fittings will be considered.
    (b)(1) The harness employed on Type B supplied-air respirators 
shall not be uncomfortable, disturbing, or interfere with the movements 
of the wearer.
    (2) The harness shall be easily adjustable to various sizes.
    (3) The hose shall be attached to the harness in a manner that will 
withstand a pull of 45 kg. (100 pounds) for 30 minutes without 
separating or showing signs of failure. [[Page 30378]] 
    (4) The design of the harness and attachment of the line shall 
permit dragging the maximum length of hose considered for approval over 
a concrete floor without disarranging the harness or exerting a pull on 
the facepiece.
    (5) The arrangement and suitability of all harness accessories and 
fittings will be considered.
    (c) The harness employed on Type C respirators shall be similar to 
that required on the Type B respirator, or, it may consist of a simple 
arrangement for attaching the hose to a part of the wearer's clothing 
in a practical manner that prevents a pull equivalent to dragging the 
maximum length of the hose over a concrete floor from exerting pull 
upon the respiratory-inlet covering.
    (d) Where supplied-air respirators have a rigid or partly rigid 
head covering, a suitable harness shall be required to assist in 
holding this covering in place.


Sec. 84.152  Breathing tube test; minimum requirements.

    (a)(1) Type A and Type B supplied-air respirators shall employ one 
or two flexible breathing tubes of the nonkinking type which extend 
from the facepiece to a connecting hose coupling attached to the belt 
or harness.
    (2) The breathing tubes employed shall permit free head movement, 
insure against closing off by kinking or by chin or arm pressure, and 
they shall not create a pull that will loosen the facepiece or disturb 
the wearer.
    (b) Breathing tubes employed on Type C supplied-air respirators of 
the continuous flow class shall meet the minimum requirements set forth 
in paragraph (a) of this section, however, an extension of the 
connecting hose may be employed in lieu of the breathing tubes 
required.
    (c)(1) A flexible, nonkinking type breathing tube shall:
    (i) Be employed on Type C supplied-air respirators of the demand 
and pressure-demand class; and
    (ii) Extend from the facepiece to the demand or pressure-demand 
valve, except where the valve is attached directly to the facepiece.
    (2) The breathing tube shall permit free head movement, insure 
against closing off by kinking or by chin or arm pressure, and shall 
not create a pull that will loosen the facepiece or disturb the wearer.
Sec. 84.153  Airflow resistance test, Type A and Type AE supplied-air 
respirators; minimum requirements.

    (a) Airflow resistance will be determined when the respirator is 
completely assembled with the respiratory-inlet covering, the air-
supply device, and the maximum length of air-supply hose coiled for 
one-half its length in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.
    (b) The inhalation resistance, drawn at the rate of 85 liters (3 
cubic feet) per minute when the blower is not operating or under any 
practical condition of blower operation shall not exceed the following 
amounts:

------------------------------------------------------------------------
 Maximum length of hose for which     Maximum resistance, water column  
      respirator is approved                       height               
------------------------------------------------------------------------
      Feet             Meters            Inches           Millimeters   
------------------------------------------------------------------------
  75............             23               1.5                 38    
  150...........             46               2.5                 64    
  250...........             76               3.5                 89    
  300...........             91               4.0                102    
------------------------------------------------------------------------

    (c) The exhalation resistance shall not exceed 25 mm. (1 inch) of 
water-column height at a flow rate of 85 liters (3 cubic feet) per 
minute when the blower is not operating or under any practical 
condition of blower operation.


Sec. 84.154  Airflow resistance test; Type B and Type BE supplied-air 
respirators; minimum requirements.

    (a) Airflow resistance shall be determined when the respirator is 
completely assembled with the respiratory-inlet covering and the hose 
in the maximum length to be considered for approval, coiled in loops 
1.5 to 2.1 m. (5 to 7 feet) in diameter.
    (b) Airflow resistance shall not exceed 38 mm. (1.5 inches) of 
water-column height to air drawn at the flow rate of 85 liters (3 cubic 
feet) per minute.
    (c) The exhalation resistance shall not exceed 25 mm. (1 inch) of 
water-column height at this flow rate.


Sec. 84.155  Airflow resistance test; Type C supplied-air respirator, 
continuous flow class and Type CE supplied-air respirator; minimum 
requirements.

    The resistance to air flowing from the respirator shall not exceed 
25 mm. (1 inch) of water-column height when the air flow into the 
respiratory-inlet covering is 115 liters (4 cubic feet) per minute.


Sec. 84.156  Airflow resistance test; Type C supplied-air respirator, 
demand class; minimum requirements.

    (a) Inhalation resistance shall not exceed 50 millimeters (2 
inches) of water at an air flow of 115 liters (4 cubic feet) per 
minute.
    (b) The exhalation resistance to a flow of air at a rate of 85 
liters (3 cubic feet) per minute shall not exceed 25 millimeters (1 
inch) of water.


Sec. 84.157  Airflow resistance test; Type C supplied-air respirator, 
pressure-demand class; minimum requirements.

    (a) The static pressure in the facepiece shall not exceed 38 mm. 
(1.5 inches) of water-column height.
    (b) The pressure in the facepiece shall not fall below atmospheric 
at inhalation airflows less than 115 liters (4 cubic feet) per minute.
    (c) The exhalation resistance to a flow of air at a rate of 85 
liters (3 cubic feet) per minute shall not exceed the static pressure 
in the facepiece by more than 51 mm. (2 inches) of water-column height.


Sec. 84.158  Exhalation valve leakage test.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.


Sec. 84.159  Man tests for gases and vapors; supplied-air respirators; 
general performance requirements.

    (a) Wearers will enter a chamber containing a gas or vapor as 
prescribed in Secs. 84.160, 84.161, 84.162, and 84.163.
    (b) Each wearer will spend 10 minutes in work to provide 
observations on freedom of the device from leakage. The freedom and 
comfort allowed the wearer will also be considered.
    (c) Time during the test period will be divided as follows:
    (1) Five minutes. Walking, turning head, dipping chin; and
    (2) Five minutes. Pumping air with a tire pump into a 28-liter (1 
cubic foot) container, or equivalent work. [[Page 30379]] 
    (d) No odor of the test gas or vapor shall be detected by the 
wearer in the air breathed during any such test, and the wearer shall 
not be subjected to any undue discomfort or encumbrance because of the 
fit, air delivery, or other features of the respirator during the 
testing period.


Sec. 84.160  Man test for gases and vapors; Type A and Type AE 
respirators; test requirements.

    (a) The completely assembled respirator will be worn in a chamber 
containing 0.1<plus-minus>0.025 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 0.1<plus-minus>0.025 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 0.1<plus-minus>0.025 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 0.1<plus-minus>0.025 percent isoamyl acetate vapor, the 
intake of the hose will be connected to a suitable source of respirable 
air, and not more than 25 percent of the hose length will be located in 
isoamyl acetate-free air.
    (b) The test will be conducted at the minimum pressure with the 
maximum hose length and will be repeated at the maximum pressure with 
the minimum hose length.
Tables to Subpart J of Part 84

             Table 8--Air-Supply-Line Requirements and Tests            
                       [42 CFR part 84, subpart J]                      
------------------------------------------------------------------------
                  Requirements for the air-supply lines of the indicated
    Specific                 type of supplied-air respirators           
  requirements   -------------------------------------------------------
                       Type A           Type B             Type C       
------------------------------------------------------------------------
Length of hose..  Maximum of 91    Maximum of 23    Maximum of 91 m.    
                   m. (300 feet),   m. (75 feet)     (300 feet) in      
                   in multiples     in multiples     multiples of 7.6 m.
                   of 7.6 m. (25    of 7.6 m. (25    (25 feet). It will 
                   feet).           feet).           be permissible for 
                                                     the applicant to   
                                                     supply hose of the 
                                                     approved type of   
                                                     shorter length than
                                                     7.6 m. (25 feet)   
                                                     provided it meets  
                                                     the requirements of
                                                     the part.          
Air flow........  None...........  None...........  The air-supply hose 
                                                     with air regulating
                                                     valve or orifice   
                                                     shall permit a flow
                                                     of not less than   
                                                     115 liters (4 cubic
                                                     feet) per minute to
                                                     tight-fitting and  
                                                     170 liters (6 cubic
                                                     feet) per minute to
                                                     loose-fitting      
                                                     respiratory-inlet  
                                                     coverings through  
                                                     the maximum length 
                                                     of hose for which  
                                                     approval is granted
                                                     and at the minimum 
                                                     specified air-     
                                                     supply pressure.   
                                                     The maximum flow   
                                                     shall not exceed   
                                                     425 liters (15     
                                                     cubic feet) per    
                                                     minute at the      
                                                     maximum specified  
                                                     air-supply pressure
                                                     with the minimum   
                                                     length of hose for 
                                                     which approval is  
                                                     granted.           
[[Page 30380]]
                                                                        
Air flow........  ......do.......  ......do.......  The air-supply hose,
                                                     detachable         
                                                     coupling, and      
                                                     demand valve of the
                                                     demand class or    
                                                     pressure-demand    
                                                     valve of the       
                                                     pressure-demand    
                                                     class for Type C   
                                                     supplied-air       
                                                     respirators, demand
                                                     and pressure-demand
                                                     classes, shall be  
                                                     capable of         
                                                     delivering         
                                                     respirable air at a
                                                     rate of not less   
                                                     than 115 liters (4 
                                                     cubic feet) per    
                                                     minute to the      
                                                     respiratory-inlet  
                                                     covering at an     
                                                     inhalation         
                                                     resistance not     
                                                     exceeding 50       
                                                     millimeters (2     
                                                     inches) of water-  
                                                     column height      
                                                     measured in the    
                                                     respiratory-inlet  
                                                     covering with any  
                                                     combination of air-
                                                     supply pressure and
                                                     length of hose     
                                                     within the         
                                                     applicant's        
                                                     specified range of 
                                                     pressure and hose  
                                                     length. The air-   
                                                     flow rate and      
                                                     resistance to      
                                                     inhalation shall be
                                                     measured while the 
                                                     demand or pressure-
                                                     demand valve is    
                                                     actuated 20 times  
                                                     per minute by a    
                                                     source of          
                                                     intermittent       
                                                     suction. The       
                                                     maximum rate of    
                                                     flow to the        
                                                     respiratory-inlet  
                                                     covering shall not 
                                                     exceed 425 liters  
                                                     (15 cubic feet) per
                                                     minute under the   
                                                     specified operating
                                                     conditions.        
Air-regulating    ......do.......  ......do.......  If an air-regulating
 valve.                                              valve is provided, 
                                                     it shall be so     
                                                     designed that it   
                                                     will remain at a   
                                                     specific           
                                                     adjustment, which  
                                                     will not be        
                                                     affected by the    
                                                     ordinary movement  
                                                     of the wearer. The 
                                                     valve must be so   
                                                     constructed that   
                                                     the air supply with
                                                     the maximum length 
                                                     of hose and at the 
                                                     minimum specified  
                                                     air-supply pressure
                                                     will not be less   
                                                     than 115 liters (4 
                                                     cubic feet) of air 
                                                     per minute to tight-
                                                     fitting and 170    
                                                     liters (6 cubic    
                                                     feet) of air per   
                                                     minute of loose-   
                                                     fitting respiratory
                                                     inlet coverings for
                                                     any adjustment of  
                                                     the valve. If a    
                                                     demand or pressure-
                                                     demand valve       
                                                     replaces the air-  
                                                     regulating valve,  
                                                     it shall be        
                                                     connected to the   
                                                     air-supply at the  
                                                     maximum air        
                                                     pressure for which 
                                                     approval is sought 
                                                     by means of the    
                                                     minimum length of  
                                                     air-supply hose for
                                                     which approval is  
                                                     sought. The outlet 
                                                     of the demand or   
                                                     pressure-demand    
                                                     valve shall be     
                                                     connected to a     
                                                     source of          
                                                     intermittent       
                                                     suction so that the
                                                     demand or pressure-
                                                     demand valve is    
                                                     actuated           
                                                     approximately 20   
                                                     times per minute   
                                                     for a total of     
                                                     100,000            
                                                     inhalations. To    
                                                     expedite this test,
                                                     the rate of        
                                                     actuation may be   
                                                     increased if       
                                                     mutually agreeable 
                                                     to the applicant   
                                                     and NIOSH. During  
                                                     this test the valve
                                                     shall function     
                                                     without failure and
                                                     without excessive  
                                                     wear of the moving 
                                                     parts. The demand  
                                                     or pressure-demand 
                                                     valve shall not be 
                                                     damaged in any way 
                                                     when subjected at  
                                                     the outlet to a    
                                                     pressure or suction
                                                     of 25 cm. (10      
                                                     inches) of water   
                                                     gage for 2 minutes.
Noncollapsibilit  The hose shall   Same as Type A.  None.               
 y.                not collapse                                         
                   or exhibit                                           
                   permanent                                            
                   deformation                                          
                   when a force                                         
                   of 90 kg. (200                                       
                   pounds) is                                           
                   applied for 5                                        
                   minutes                                              
                   between 2                                            
                   planes 7.6 cm.                                       
                   (3 inches)                                           
                   wide on                                              
                   opposite sides                                       
                   of the hose.                                         
[[Page 30381]]
                                                                        
Nonkinkability..  None...........  None...........  A 7.6 m. (25 foot)  
                                                     section of the hose
                                                     will be placed on a
                                                     horizontal-plane   
                                                     surface and shaped 
                                                     into a one-loop    
                                                     coil with one end  
                                                     of the hose        
                                                     connected to an    
                                                     airflow meter and  
                                                     the other end of   
                                                     the hose supplied  
                                                     with air at the    
                                                     minimum specified  
                                                     supply pressure.   
                                                     The connection     
                                                     shall be in the    
                                                     plane of the loop. 
                                                     The other end of   
                                                     the hose will be   
                                                     pulled tangentially
                                                     to the loop and in 
                                                     the plane of the   
                                                     loop until the hose
                                                     straightens. To    
                                                     meet the           
                                                     requirements of    
                                                     this test the loop 
                                                     shall maintain a   
                                                     uniform near-      
                                                     circular shape and 
                                                     ultimately unfold  
                                                     as a spiral,       
                                                     without any        
                                                     localized          
                                                     deformation that   
                                                     decreases the flow 
                                                     of air to less than
                                                     90 percent of the  
                                                     flow when the hose 
                                                     is tested while    
                                                     remaining in a     
                                                     straight line.     
Strength of hose  Hose and         Same as Type A.  Hose and couplings  
 and couplings.    couplings                         shall not exhibit  
                   shall not                         any separation or  
                   separate or                       failure when tested
                   fail when                         with a pull of 45  
                   tested with a                     kg. (100 pounds)   
                   pull of 113                       for 5 minutes and  
                   kg. (250                          when tested by     
                   pounds) for 5                     subjecting them to 
                   minutes.                          an internal air    
                                                     pressure of 2 times
                                                     the maximum        
                                                     respirator-supply  
                                                     pressure that is   
                                                     specified by the   
                                                     applicant or at 173
                                                     kN/m. 2 (25 pounds 
                                                     per square inch)   
                                                     gage, whichever is 
                                                     higher.            
Tightness.......  No air leakage   None...........  Leakage of air      
                   shall occur                       exceeding 50 cc.   
                   when the hose                     per minute at each 
                   and couplings                     coupling shall not 
                   are joined and                    be permitted when  
                   the joint(s)                      the hose and       
                   are immersed                      couplings are      
                   in water and                      joined and are     
                   subjected to                      immersed in water, 
                   an internal                       with air flowing   
                   air pressure                      through the        
                   of 35 kN/m. 2                     respirator under a 
                   (5 pounds per                     pressure of 173 kN/
                   square inch)                      m. 2 (25 pounds per
                   gage.                             square inch) gage  
                                                     applied to the     
                                                     inlet end of the   
                                                     air-supply hose, or
                                                     at twice the       
                                                     maximum respirator-
                                                     supply pressure    
                                                     that is specified  
                                                     by the applicant,  
                                                     whichever is       
                                                     higher.            
Permeation of     The permeation   Same as for      Same as for Type A, 
 hose by           of the hose by   Type A.          except the test    
 gasoline.         gasoline will                     period shall be 1  
                   be tested by                      hour.              
                   immersing 7.6                                        
                   m. (25 feet)                                         
                   of hose and                                          
                   one coupling                                         
                   in gasoline,                                         
                   with air                                             
                   flowing                                              
                   through the                                          
                   hose at the                                          
                   rate of 8                                            
                   liters per                                           
                   minute for 6                                         
                   hours. The air                                       
                   from the hose                                        
                   shall not                                            
                   contain more                                         
                   than 0.01                                            
                   percent by                                           
                   volume of                                            
                   gasoline vapor                                       
                   at the end of                                        
                   the test.                                            
Detachable        None...........  None...........  A hand-operated     
 coupling.                                           detachable coupling
                                                     by which the wearer
                                                     can readily attach 
                                                     or detach the      
                                                     connecting hose    
                                                     shall be provided  
                                                     at a convenient    
                                                     location. This     
                                                     coupling shall be  
                                                     durable, remain    
                                                     connected under all
                                                     conditions of      
                                                     normal respirator  
                                                     use, and meet the  
                                                     prescribed tests   
                                                     for strength and   
                                                     tightness of hose  
                                                     and couplings.     
------------------------------------------------------------------------

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


Sec. 84.170  Non-powered air-purifying particulate respirators; 
description.

    (a) Non-powered air-purifying particulate respirators utilize the 
wearer's negative inhalation pressure to draw the ambient air through 
the air-purifying filter elements (filters) to remove particulates from 
the ambient air. They are designed for use as respiratory protection 
against atmospheres with particulate contaminants (e.g., dusts, fumes, 
mists) that are not immediately dangerous to life or health and that 
contain adequate oxygen to support life.
    (b) Non-powered air-purifying particulate respirators are 
classified into three series, N-, R-, and P-series. The N-series 
filters are restricted to use in those workplaces free of oil aerosols. 
The R- and P-series filters are intended for removal of any particulate 
that includes oil-based liquid particulates.
    (c) Non-powered air-purifying particulate respirators are 
classified according to the efficiency level of the filter(s) as tested 
according to the requirements of this part.
    (1) N100, R100, and P100 filters shall demonstrate a minimum 
efficiency level of 99.97 percent.
    (2) N99, R99, and P99 filters shall demonstrate a minimum 
efficiency level of 99 percent. [[Page 30382]] 
    (3) N95, R95, and P95 filters shall demonstrate a minimum 
efficiency level of 95 percent.


Sec. 84.171  Non-powered air-purifying particulate respirators; 
required components.

    (a) Each non-powered air-purifying particulate respirator described 
in Sec. 84.170 shall, where its design requires, contain the following 
component parts:
    (1) Facepiece, mouthpiece with noseclip, hood, or helmet;
    (2) Filter unit;
    (3) Harness;
    (4) Attached blower; and
    (5) Breathing tube.
    (b) The components of each non-powered air-purifying particulate 
respirator shall meet the minimum construction requirements set forth 
in subpart G of this part.


Sec. 84.172  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with respirators shall 
be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm 
pressure.


Sec. 84.173  Harnesses; installation and construction; minimum 
requirements.

    (a) Each respirator shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
respirator in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of respirator parts, and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.


Sec. 84.174  Respirator containers; minimum requirements.

    (a) Except as provided in paragraph (b) of this section each 
respirator shall be equipped with a substantial, durable container 
bearing markings which show the applicant's name, the type of 
respirator it contains, and all appropriate approval labels.
    (b) Containers for single-use respirators may provide for storage 
of more than one respirator, however, such containers shall be designed 
and constructed to prevent contamination of respirators which are not 
removed, and to prevent damage to respirators during transit.


Sec. 84.175  Half-mask facepieces, full facepieces, hoods, helmets, and 
mouthpieces; fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for optional use of corrective 
spectacles or lenses, which shall not reduce the respiratory protective 
qualities of the respirator.
    (c) Hoods and helmets shall be designed and constructed to fit 
persons with various head sizes, provide for the optional use of 
corrective spectacles or lenses, and insure against any restriction of 
movement by the wearer.
    (d) Mouthpieces shall be equipped with noseclips which are securely 
attached to the mouthpiece or respirator and provide an airtight seal.
    (e) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.
    (f) Half-mask facepieces shall not interfere with the fit of common 
industrial safety corrective spectacles.


Sec. 84.176  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.

    Facepieces, hoods, and helmets shall be designed and constructed to 
provide adequate vision which is not distorted by the eyepieces.


Sec. 84.177  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be protected against 
distortion.
    (b) Inhalation valves shall be designed and constructed and 
provided where necessary to prevent excessive exhaled air from 
adversely affecting filters, except where filters are specifically 
designed to resist moisture.
    (c) Exhalation valves shall be:
    (1) Provided where necessary;
    (2) Protected against damage and external influence; and
    (3) Designed and constructed to prevent inward leakage of 
contaminated air.


Sec. 84.178  Head harnesses; minimum requirements.

    (a) All facepieces shall be equipped with head harnesses designed 
and constructed to provide adequate tension during use and an even 
distribution of pressure over the entire area in contact with the face.
    (b) Facepiece head harnesses, except those employed on single-use 
respirators, shall be adjustable and replaceable.
    (c) Mouthpieces shall be equipped, where applicable, with 
adjustable and replaceable harnesses, designed and constructed to hold 
the mouthpiece in place.


Sec. 84.179  Non-powered air-purifying particulate respirators; filter 
identification.

    (a) The respirator manufacturer, as part of the application for 
certification, shall specify the filter series and the filter 
efficiency level (i.e., ``N95'', ``R95, ``P95'', ``N99, ``R99'', 
``P99'', ``N100'', ``R100'', or ``P100'') for which certification is 
being sought.
    (b) Filters shall be prominently labeled as follows:
    (1) N100 filters shall be labeled ``N100 Particulate Filter (99.97% 
filter efficiency level)'' and shall be a color other than magenta.
    (2) R100 filters shall be labeled ``R100 Particulate Filter (99.97% 
filter efficiency level)'' and shall be a color other than magenta.
    (3) P100 filters shall be labeled ``P100 Particulate Filter (99.97% 
filter efficiency level)'' and shall be color coded magenta.
    (4) N99 filters shall be labeled ``N99 Particulate Filter (99% 
filter efficiency level)'' and shall be a color other than magenta.
    (5) R99 filters shall be labeled ``R99 Particulate Filter (99% 
filter efficiency level)'' and shall be a color other than magenta.
    (6) P99 filters shall be labeled ``P99 Particulate Filter (99% 
filter efficiency level)'' and shall be a color other than magenta.
    (7) N95 filters shall be labeled as ``N95 Particulate Filter (95% 
filter efficiency level)'' and shall be a color other than magenta.
    (8) R95 filters shall be labeled as ``R95 Particulate Filter (95% 
filter efficiency level)'' and shall be a color other than magenta.
    (9) P95 filters shall be labeled as ``P95 Particulate Filter (95% 
filter efficiency level)'' and shall be a color other than magenta.


Sec. 84.180  Airflow resistance tests.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a particulate respirator (complete 
respirator) mounted on a test fixture with air flowing at continuous 
rate of 85<plus-minus>2 liters per minute, before each test conducted 
in accordance with Sec. 84.182.
    (b) The resistances for particulate respirators upon initial 
inhalation shall not exceed 35 mm water column height pressure and upon 
initial exhalation shall not exceed 25 mm water column height 
pressure. [[Page 30383]] 


Sec. 84.181  Non-powered air-purifying particulate filter efficiency 
level determination.

    (a) Twenty filters of each non-powered air-purifying particulate 
respirator model shall be tested for filter efficiency against:
    (1) A solid sodium chloride particulate aerosol as per this 
section, if N-series certification is requested by the applicant.
    (2) A dioctyl phthalate or equivalent liquid particulate aerosol as 
per this section, if R-series or P-series certification is requested by 
the applicant.
    (b) Filters including holders and gaskets; when separable, shall be 
tested for filter efficiency level, as mounted on a test fixture in the 
manner as used on the respirator.
    (c) Prior to filter efficiency testing of 20 N-series filters, the 
20 to be tested shall be taken out of their packaging and placed in an 
environment of 85<plus-minus>5 percent relative humidity at 
38<plus-minus>2.5  deg.C for 25<plus-minus>1 hours. Following the pre-
conditioning, filters shall be sealed in a gas-tight container and 
tested within 10 hours.
    (d) When the filters do not have separable holders and gaskets, the 
exhalation valves shall be blocked so as to ensure that leakage, if 
present, is not included in the filter efficiency level evaluation.
    (e) For non-powered air-purifying particulate respirators with a 
single filter, filters shall be tested at a continuous airflow rate of 
85<plus-minus>4 liters per minute. Where filters are to be used in 
pairs, the test-aerosol airflow rate shall be 42.5<plus-minus>2 liters 
per minute through each filter.
    (f) Filter efficiency test aerosols.
    (1) When testing N-series filters, a sodium chloride or equivalent 
solid aerosol at 25<plus-minus>5  deg.C and relative humidity of 
30<plus-minus>10 percent that has been neutralized to the Boltzmann 
equilibrium state shall be used. Each filter shall be challenged with a 
concentration not exceeding 200 mg/m\3\.
    (2) When testing R-series and P-series filters, a neat cold-
nebulized dioctyl phthalate (DOP) or equivalent aerosol at 
25<plus-minus>5  deg.C that has been neutralized to the Boltzmann 
equilibrium state shall be used. Each filter shall be challenged with a 
concentration not exceeding 200 mg/m\3\.
    (3) The test shall continue until minimum efficiency is achieved or 
until an aerosol mass of at least 200<plus-minus>5 mg has contacted the 
filter. For P-series filters, if the filter efficiency is decreasing 
when the 200<plus-minus>5 mg challenge point is reached, the test shall 
be continued until there is no further decrease in efficiency.
    (g) The sodium chloride test aerosol shall have a particle size 
distribution with count median diameter of 0.075<plus-minus>0.020 
micrometer and a standard geometric deviation not exceeding 1.86 at the 
specified test conditions as determined with a scanning mobility 
particle sizer or equivalent. The DOP aerosol shall have a particle 
size distribution with count median diameter of 0.185<plus-minus>0.020 
micrometer and a standard geometric deviation not exceeding 1.60 at the 
specified test conditions as determined with a scanning mobility 
particle sizer or equivalent.
    (h) The efficiency of the filter shall be monitored and recorded 
throughout the test period by a suitable forward-light-scattering 
photometer or equivalent instrumentation.
    (i) The minimum efficiency for each of the 20 filters shall be 
determined and recorded and be equal to or greater than the filter 
efficiency criterion listed for each level as follows:

P100, R100 and N100: Efficiency <gr-thn-eq>99.97%
P99, R99 and N99: Efficiency <gr-thn-eq>99%
P95, R95 and N95: Efficiency <gr-thn-eq>95%


Sec. 84.182  Exhalation valve leakage test; minimum requirements.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.
Subpart L--Chemical Cartridge Respirators


Sec. 84.190  Chemical cartridge respirators: description.

    (a) Chemical cartridge respirators including all completely 
assembled respirators which are designed for use as respiratory 
protection during entry into or escape from atmospheres not immediately 
dangerous to life and health, are described according to the specific 
gases or vapors against which they are designed to provide respiratory 
protection, as follows:

------------------------------------------------------------------------
                                                            Maximum use 
                                                          concentration,
        Type of chemical cartridge respirator \1\            parts per  
                                                              million   
------------------------------------------------------------------------
Ammonia.................................................            300 
Chlorine................................................             10 
Hydrogen chloride.......................................             50 
Methyl amine............................................            100 
Organic vapor...........................................      \2\ 1,000 
Sulfur dioxide..........................................             50 
Vinyl chloride..........................................             10 
------------------------------------------------------------------------
\1\ Not for use against gases or vapors with poor warning properties    
  (except where MSHA or Occupational Safety and Health Administration   
  standards may permit such use for a specific gas or vapor) or those   
  which generate high heats of reaction with sorbent material in the    
  cartridge.                                                            
\2\ Maximum use concentrations are lower for organic vapors which       
  produce atmospheres immediately hazardous to life or health at        
  concentrations equal to or lower than this concentration.             

    (b) Chemical cartridge respirators for respiratory protection 
against gases or vapors, which are not specifically listed with their 
maximum use concentration, may be approved if the applicant submits a 
request for such approval, in writing, to the Institute. The Institute 
shall consider each such application and accept or reject the 
application after a review of the effects on the wearer's health and 
safety and in the light of any field experience in use of chemical 
cartridge respirators as protection against such hazards.


Sec. 84.191  Chemical cartridge respirators; required components.

    (a) Each chemical cartridge respirator described in Sec. 84.190 
shall, where its design requires, contain the following component 
parts:
    (1) Facepiece, mouthpiece, and noseclip, hood, or helmet;
    (2) Cartridge;
    (3) Cartridge with filter;
    (4) Harness;
    (5) Breathing tube; and
    (6) Attached blower.
    (b) The components of each chemical cartridge respirator shall meet 
the minimum construction requirements set forth in subpart G of this 
part.


Sec. 84.192  Cartridges in parallel; resistance requirements.

    Where two or more cartridges are used in parallel, their resistance 
to airflow shall be essentially equal.


Sec. 84.193  Cartridges; color and markings; requirements.

    The color and markings of all cartridges or labels shall conform 
with the requirements of the American National Standards Institute, 
American National Standard for Identification of Air-Purifying 
Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is 
incorporated by reference and has been approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies may be obtained from American [[Page 30384]] National Standards 
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be 
inspected at the NIOSH, Certification and Quality Assurance Branch, 
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.


Sec. 84.194  Filters used with chemical cartridges; location; 
replacement.

    (a) Particulate matter filters used in conjunction with a chemical 
cartridge shall be located on the inlet side of the cartridge.
    (b) Filters shall be incorporated in or firmly attached to the 
cartridge and each filter assembly shall, where applicable, be designed 
to permit its easy removal from and replacement on the cartridge.


Sec. 84.195  Breathing tubes; minimum requirements.

    Flexible breathing tubes used in conjunction with respirators shall 
be designed and constructed to prevent:
    (a) Restriction of free head movement;
    (b) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (c) Interference with the wearer's activities; and
    (d) Shutoff of airflow due to kinking, or from chin or arm 
pressure.


Sec. 84.196  Harnesses; installation and construction; minimum 
requirements.

    (a) Each respirator shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
respirator in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of respirator parts and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.


Sec. 84.197  Respirator containers; minimum requirements.

    Respirators shall be equipped with a substantial, durable container 
bearing markings which show the applicant's name, the type and 
commercial designation of the respirator it contains and all 
appropriate approval labels.


Sec. 84.198  Half-mask facepieces, full facepieces, mouthpieces, hoods, 
and helmets; fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Hoods and helmets shall be designed and constructed to fit 
persons with various head sizes, provide for the optional use of 
corrective spectacles or lenses, and insure against any restriction of 
movement by the wearer.
    (c) Mouthpieces shall be equipped with noseclips which are securely 
attached to the mouthpiece or respirator and provide an airtight fit.
    (d) Full facepieces shall provide for optional use of corrective 
spectacles or lenses which shall not reduce the respiratory protective 
qualities of the respirator.
    (e) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.


Sec. 84.199  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.

    Facepieces, hoods, and helmets shall be designed and constructed to 
provide adequate vision which is not distorted by the eyepieces.


Sec. 84.200  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against distortion.
    (b) Inhalation valves shall be designed and constructed to prevent 
excessive exhaled air from entering cartridges or adversely affecting 
canisters.
    (c) Exhalation valves shall be--
    (1) Protected against damage and external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.


Sec. 84.201  Head harnesses; minimum requirements.

    (a) (1) Facepieces for chemical cartridge respirators other than 
single-use vinyl chloride shall be equipped with adjustable and 
replaceable head harnesses designed and constructed to provide adequate 
tension during use and an even distribution of pressure over the entire 
area in contact with the face.
    (2) Facepieces for single-use vinyl chloride respirators shall be 
equipped with adjustable head harnesses designed and constructed to 
provide adequate tension during use and an even distribution of 
pressure over the entire area in contact with the face.
    (b) Mouthpieces shall be equipped where applicable, with an 
adjustable and replaceable harness designed and constructed to hold the 
mouthpiece in place.


Sec. 84.202  Air velocity and noise levels; hoods and helmets; minimum 
requirements.

    Noise levels generated by the respirator will be measured inside 
the hood or helmet at maximum airflow obtainable and shall not exceed 
80 dBA.


Sec. 84.203  Breathing resistance test; minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a chemical cartridge respirator mounted 
on a test fixture with air flowing at a continuous rate of 85 liters 
per minute, both before and after each test conducted in accordance 
with Secs. 84.206 through 84.207.
    (b) The maximum allowable resistance requirements for chemical 
cartridge respirators are as follows:

                           Maximum Resistance                           
                    [Millimeter water column height]                    
------------------------------------------------------------------------
                                          Inhalation                    
    Type of chemical-cartridge    --------------------------  Exhalation
            respirator               Initial      Final\1\              
------------------------------------------------------------------------
Other than single-use vinyl                                             
 chloride respirators:                                                  
    For gases, vapors, or gases                                         
     and vapors..................           40           45           20
    For gases, vapors, or gases                                         
     and vapors, and particulates           50           70           20
Single-use respirator with                                              
 valves:                                                                
    For vinyl chloride...........           20           25           20
    For vinyl chloride and                                              
     particulates................           30           45            2
Single-use respirator without                                           
 valves:                                                                
    For vinyl chloride...........           15           20          (<SUP>2)
    For vinyl chloride and                                              
     particulates................           25           40          (<SUP>2)
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 of this       
  subpart.                                                              
[[Page 30385]]
                                                                        
\2\ Same as inhalation.                                                 

Sec. 84.204  Exhalation valve leakage test; minimum requirements.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.


Sec. 84.205  Facepiece test; minimum requirements.

    (a) The complete chemical cartridge respirator will be fitted to 
the faces of persons having varying facial shapes and sizes.
    (b) Where the applicant specifies a facepiece size or sizes for the 
respirator together with the approximate measurement of faces they are 
designed to fit, the Institute will provide test subjects to suit such 
facial measurements.
    (c) Any chemical cartridge respirator part which must be removed to 
perform the facepiece or mouthpiece fit test shall be replaceable 
without special tools and without disturbing facepiece or mouthpiece 
fit.
    (d) The facepiece or mouthpiece fit test using the positive or 
negative pressure recommended by the applicant and described in his 
instructions will be used before each test.
    (e) (1) Each wearer will enter a chamber containing 100 p.p.m. 
isoamyl acetate vapor for half-mask facepieces, and 1,000 p.p.m. for 
full facepieces, mouthpieces, hoods, and helmets.
    (2) The facepiece or mouthpiece may be adjusted, if necessary, in 
the test chamber before starting the test.
    (3) Each wearer will remain in the chamber for 8 minutes while 
performing the following activities:
    (i) Two minutes, nodding and turning head;
    (ii) Two minutes, calisthenic arm movements;
    (iii) Two minutes, running in place; and
    (iv) Two minutes, pumping with a tire pump into a 28-liter (1 
cubic-foot) container.
    (4) Each wearer shall not detect the odor of isoamyl-acetate vapor 
during the test.


Sec. 84.206  Particulate tests; respirators with filters; minimum 
requirements; general.

    (a) Three respirators with cartridges containing, or having 
attached to them, filters for protection against particulates will be 
tested in accordance with the provisions of Sec. 84.207.
    (b) In addition to the test requirements set forth in paragraph (a) 
of this section, three such respirators will be tested, as appropriate, 
in accordance with the provisions of Secs. 84.179 through 84.183; 
however, the maximum allowable resistance of complete particulate, and 
gas, vapor, or gas and vapor chemical cartridge respirators shall not 
exceed the maximum allowable limits set forth in Sec. 84.203.


Sec. 84.207  Bench tests; gas and vapor tests; minimum requirements; 
general.

    (a) Bench tests will be made on an apparatus that allows the test 
atmosphere at 50<plus-minus>5 percent relative humidity and room 
temperature, approximately 25  deg.C, to enter the cartridges 
continuously at predetermined concentrations and rates of flow, and 
that has means for determining the test life of the cartridges.
    (b) Where two cartridges are used in parallel on a chemical 
cartridge respirator, the bench test will be performed with the 
cartridges arranged in parallel, and the test requirements will apply 
to the combination rather than to the individual cartridges.
    (c) Three cartridges or pairs of cartridges will be removed from 
containers and tested as received from the applicant.
    (d) Two air purifying cartridges or pairs of cartridges will be 
equilibrated at room temperature by passing 25 percent relative 
humidity air through them at the flow rate of 25 liters per minute 
(l.p.m.) for 6 hours.
    (e) Two air purifying cartridges or pairs of cartridges will be 
equilibrated by passing 85 percent relative humidity air through them 
at the flow rate of 25 l.p.m.
    (f) All cartridges will be resealed, kept in an upright position, 
at room temperatures, and tested within 18 hours.
    (g) Cartridges will be tested and shall meet the minimum 
requirements set forth in Table 11 of this subpart.
Tables to Subpart L of Part 84

                                                               Tables 9 and 10 [Reserved]                                                               
                                                     Table 11-Cartridge Bench Tests and Requirements                                                    
                                                               [42 CFR part 84, subpart L]                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Test atmosphere                                                                 
                                                             -------------------------------------   Flowrate    Number of     Penetration     Minimum  
          Cartridge                    Test condition                               Concentration    (l.p.m.)      tests      \1\ (p.p.m.)     life \2\ 
                                                                  Gas or vapor         (p.p.m.)                                                 (min.)  
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ammonia......................  As received..................  NH<INF>3                           1000            64            3             50            50
Ammonia......................  Equilibrated.................  NH<INF>3                           1000            32            4             50            50
Chlorine.....................  As received..................  Cl<INF>2                            500            64            3              5            35
Chlorine.....................  Equilibrated.................  Cl<INF>2                            500            32            4              5            35
Hydrogen chloride............  As received..................  HCl                            500            64            3              5            50
Hydrogen chloride............  Equilibrated.................  HCl                            500            32            4              5            50
Methylamine..................  As received..................  CH<INF>3NH<INF>2                        1000            64            3             10            25
Methylamine..................  Equilibrated.................  CH<INF>3NH<INF>2                        1000            32            4             10            25
Organic vapors...............  As received..................  CCl<INF>4                          1000            64            3              5            50
Organic vapors...............  Equilibrated.................  CCl<INF>4                          1000            32            4              5            50
Sulfur dioxide...............  As received..................  SO<INF>2                            500            64            3              5            30
Sulfur dioxide...............  Equilibrated.................  SO<INF>2                            500            32            4              5            30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.                                                                                       
[[Page 30386]]
                                                                                                                                                        
\2\ Where a respirator is designed for respiratory protection against more than one type of gas or vapor, as for use in ammonia and in chlorine, the    
  minimum life shall be one-half that shown for each type of gas or vapor. Where a respirator is designed for respiratory protection against more than  
  one gas of a type, as for use in chlorine and sulfur dioxide, the stated minimal life shall apply.                                                    

Subpart M--[Reserved]

Subpart N--Special Use Respirators


Sec. 84.250  Vinyl chloride respirators; description.

    Vinyl chloride respirators, including all completely assembled 
respirators which are designed for use as respiratory protection during 
entry into and escape from vinyl chloride atmospheres containing 
adequate oxygen to support life, are described according to their 
construction as follows:
    (a) Front-mounted or back-mounted gas masks;
    (b) Chin-style gas masks;
    (c) Chemical-cartridge respirators;
    (d) Powered air-purifying respirators; and
    (e) Other devices, including combination respirators.


Sec. 84.251  Required components.

    (a) Each vinyl chloride respirator described in Sec. 84.250 shall, 
where its design requires, contain the following component parts:
    (1) Facepiece;
    (2) Canister with end-of-service-life indicator;
    (3) Cartridge with end-of-service-life indicator;
    (4) Harness;
    (5) Attached blower; and
    (6) Breathing tube.
    (b) The components of each vinyl chloride respirator shall meet the 
minimum construction requirements set forth in Subpart G of this part.


Sec. 84.252  Gas masks; requirements and tests.

    (a) Except for the tests prescribed in Sec. 84.126, the minimum 
requirements and performance tests for gas masks, prescribed in Subpart 
I of this part, are applicable to vinyl chloride gas masks.
    (b) The following bench tests are applicable to canisters designed 
for use with gas masks for entry into and escape from vinyl chloride 
atmospheres containing adequate oxygen to support life:
    (1) Four canisters will be equilibrated at 25<plus-minus>5  deg.C 
by passing 85<plus-minus>5 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 85<plus-minus>5 percent 
relative humidity and 25<plus-minus>5  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 
25<plus-minus>5  deg.C by passing 85<plus-minus>5 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<plus-minus>5 percent relative humidity 
and 25<plus-minus>5  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 85<plus-minus>5 
percent relative humidity and 25<plus-minus>5  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 40<plus-minus>0.6 liters. Air exhaled through the 
respirator will be 35<plus-minus>2  deg.C with 94<plus-minus>3 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<plus-minus>  deg.C 
by passing 85<plus-minus>5 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 85<plus-minus>5 percent 
relative [[Page 30387]] humidity and 25<plus-minus>5  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 80<plus-minus>10 percent of the total service 
life to 1 ppm leakage, as determined by continuing each test described 
in Secs. 84.252(b), 84.253(b), and 84.254(b) until a 1 ppm leakage of 
vinyl chloride occurs.
    (b) The applicant shall provide sufficient pretest data to verify 
the performance of the end-of-service-life indicator required in 
paragraph (a) of this section.


Sec. 84.256  Quality control requirements.

    (a) In addition to the construction and performance requirements 
specified in Secs. 84.251, 84.252, 84.253, 84.254, and 84.255, the 
quality control requirements in paragraphs (b), (c), and (d) of this 
section apply to approval of gas masks, chemical cartridge respirators, 
and powered air-purifying respirators for entry into and escape from 
vinyl chloride atmospheres containing adequate oxygen to support life.
    (b) The respirators submitted for approval as described in 
paragraph (a) of this section shall be accompanied by a complete 
quality control plan meeting the requirements of subpart E of this 
part.
    (c) (1) The applicant shall specify in the plan that a sufficient 
number of samples will be drawn from each bulk container of sorbent 
material and that where activated carbon is used, the following 
specific tests will be performed:
    (i) Apparent density;
    (ii) Iodine number;
    (iii) Moisture content;
    (iv) Carbon tetrachloride number; and
    (v) Mesh size.
    (2) The tests in paragraph (c)(1) of this section shall be 
performed in a quantity necessary to assure continued satisfactory 
conformance of the canisters and cartridges to the requirements of this 
subpart.
    (d) Final performance quality control tests on the complete 
canisters and cartridges shall be accomplished using the bench tests 
and procedures prescribed in Secs. 84.252, 84.253, 84.254, and 84.255.


Sec. 84.257  Labeling requirements.

    (a) A warning shall be placed on the label of each gas mask, 
chemical-cartridge respirator, and powered air-purifying respirator, 
and on the label of each canister and cartridge, alerting the wearer to 
the need for a fitting test in accordance with the manufacturer's 
facepiece fitting instructions, providing service life information, 
providing specific instructions for disposal, and advising that the 
wearer may communicate to NIOSH any difficulties that may be 
experienced in the design and performance of any gas mask, chemical-
cartridge respirator, or powered air-purifying respirator approved 
under the requirements of this subpart. The service lives of 
respirators meeting the test requirements of this subpart shall be 
specified as follows:

Chemical-cartridge respirator
1 hour.
Gas mask
4 hours.
Powered air-purifying respirator
4 hours.

    (b) Where the service life of a respirator is approved for more 
than four hours, the service life for which the respirator has been 
approved will be specified.


Sec. 84.258  Fees.

    The following fees shall be charged for the examination, 
inspection, and testing of complete assemblies and components of 
respirators described in Secs. 84.250 and 84.251:

Complete gas mask
$1,100
Complete chemical-cartridge   respirator
 1,150
Complete powered air-purifying respirator
 1,500
Canister or cartridge only
  750

Subparts O through JJ [Reserved]

Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray; Powered 
Air-Purifying High Efficiency Respirators and Combination Gas Masks


Sec. 84.1100  Scope and effective dates.

    The purpose of this subpart KK is to establish procedures and 
requirements for issuing extensions of approval of particulate 
respirators certified prior to July 10, 1995 under the provisions of 30 
CFR part 11 (See 30 CFR part 11 edition, as revised July 1, 1994.), new 
approvals and extensions of approval of particulate respirators for 
applications that are in NIOSH receipt on July 10, 1995, and approval 
of powered air-purifying respirators.
    (a) Air-purifying respirators with particulate filters approved 
under the provisions of this subpart after July 10, 1995 will have a 30 
CFR part 11 approval label.
    (b) Only changes or modifications of non-powered air-purifying 
respirators with particulate filters approved under the provisions of 
subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this 
section and deemed necessary by NIOSH to ensure the health and safety 
of the wearer will be approved until July 10, 1998 and will have a 30 
CFR part 11 approval label.
    (c) Only changes or modifications of powered air-purifying 
respirators with particulate filters approved under the provisions of 
subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this 
section and deemed necessary by NIOSH to ensure the health and safety 
of the wearer will be approved under this subpart until July 10, 1998 
and will have a 30 CFR part 11 label.
    (d) Approval of powered air-purifying respirators will be issued 
under this subpart. Particulate filters for powered air-purifying 
respirators approved under the provisions of this subpart shall be only 
high-efficiency (HEPA) as described in Sec. 84.1130(a)(4) and will 
carry a 42 CFR part 84 approval label. In addition, changes or 
modifications of powered HEPA air-purifying respirators approved under 
the provisions of this subpart KK will be approved under this subpart 
and will have a 42 CFR part 84 approval label.


Sec. 84.1101  Definitions.

    As used in this subpart
    (a) Air Contamination Level means the standards of contaminant 
levels prescribed by the Secretary of Labor in accordance with the 
provisions of the Occupational Safety and Health Act of 1970 (Pub. L. 
91-596; 84 Stat. 1590).
    (b) DOP means a homogenous liquid aerosol, having a particle 
diameter of 0.3 micrometer, which is generated by vaporization and 
condensation of dioctyl phthalate.
    (c) Pesticide means:
    (1) Any substance or mixture of substances (including solvents and 
impurities) intended to prevent, destroy, repel, or mitigate any 
insect, rodent, nematode, fungus, weed, or other form of plant or 
animal life or virus; and
    (2) Any substance or mixture of substances (including solvents and 
impurities) intended for use as a plant regulator, defoliant, or 
desiccant, as defined in the Federal Insecticide, 
[[Page 30388]] Fungicide, and Rodenticide Act of 1947, as amended (7 
U.S.C. 135-135k), excluding fumigants which are applied as gases or 
vapors or in a solid or liquid form as pellets or poured liquids for 
subsequent release as gases or vapors.
    (d) Radionuclide means an atom identified by the constitution of 
its nucleus (specified by the number of protons Z, number of neutrons 
N, and energy, or, alternatively, by the atomic number Z, mass number 
A=(N+Z), and atomic mass) which exists for a measurable time; decays or 
disintegrates spontaneously, emits radiation, and results in the 
formation of new nuclides.
    (e) Smoke means the products of incomplete combustion of organic 
substances in the form of solid and liquid particles and gaseous 
products in air, usually of sufficient concentration to perceptibility 
obscure vision.


Sec. 84.1102  Examination, inspection and testing of complete 
respirator assemblies; fees.

    The following fees shall be charged by the Institute for the 
examination, inspection and testing of complete respirator assemblies 
approved under this subpart:
    (a) Gas masks with particulate filter, including pesticide gas 
masks--
    (1) Single hazard--$1,100.
    (2) Type N--$4,100.
    (b) Dust, fume and mist respirators--
    (1) Single particulate hazard having an Air Contamination Level 
more than 0.05 mg./m.\3\ or 2 million particles per cubic foot--$500.
    (2) Combination particulate hazards having an Air Contamination 
Level more than 0.05 mg./m.\3\ or 2 million particles per cubic foot--
$750.
    (3) Particulate hazards having an Air Contamination Level less than 
0.05 mg./m.\3\ or 2 million particles per cubic foot, radon daughters 
--$1,250.
    (4) All dusts, fumes and mists--$2,000.
    (c) Paint spray respirators--$1,600.
    (d) Pesticide respirators--$1,600.
    (e) Chemical cartridge respirators with particulate filter--$1,150.


Sec. 84.1103  Approval labels and markings; approval of contents; use.

    (a) Full-scale reproductions of approval labels and markings, and a 
sketch or description of the method of application and position on the 
harness, container, canister, cartridge, filter, or other component, 
together with instructions for the use and maintenance of the 
respirator shall be submitted to MSHA and the Institute for approval.
    (b) Approval labels for non-powered and powered air-purifying dust, 
fume, mist respirators approved prior to July 10, 1995 under the 
provisions of subpart K of 30 CFR part 11 (See 30 CFR Part 11 edition, 
revised as of July 1, 1994.) shall bear the emblem of the Mine Safety 
and Health Administration and the seal of the Department of Health and 
Human Services, the applicant's name and address, an approval number 
assigned by the Institute, a statement that the respirator was tested 
and approved under subpart K of 30 CFR part 11 and, where appropriate, 
restrictions or limitations placed upon the use of the respirator by 
the Institute. The approval number assigned by the Institute shall be 
designated by the prefix TC and a serial number.
    (c) Approval labels for powered air-purifying respirators approved 
under the provisions of this subpart shall bear the emblem of the 
National Institute for Occupational Safety and Health and the seal of 
the Department of Health and Human Services, the applicant's name and 
address, an approval number assigned by the Institute, a statement 
stating the respirator was tested under the provisions of this subpart, 
and, where appropriate, restrictions or limitations placed upon the use 
of the respirator by the Institute. The approval number assigned by the 
Institute shall be designated by the prefix TC and a serial number.
    (c) The Institute shall, where necessary, notify the applicant when 
additional labels, markings, or instructions will be required.
    (d) Approval labels and markings shall only be used by the 
applicant to whom they were issued.
    (e) Legible reproductions or abbreviated forms of the label 
approved by the Institute for use on each respirator shall be attached 
to or printed at the following locations:

------------------------------------------------------------------------
     Respirator type            Label type              Location        
------------------------------------------------------------------------
Gas mask with a            Entire.............  Mask and container.     
 particulate filter,                                                    
 including pesticide gas                                                
 mask.                                                                  
Dust, fume, and mist       Entire.............  Respirator container and
 respirators.                                    filter container.      
                           Abbreviated........  Filters.                
Chemical-cartridge         Entire.............  Respirator container,   
 respirator with a                               cartridge container,   
 particulate filter,                             and filter containers  
 including paint spray                           (where applicable).    
 respirator.                                                            
                           Abbreviated........  Cartridges and filters  
                                                 and filter containers. 
Pesticide respirator.....  Entire.............  Respirator container,   
                                                 and cartridge and      
                                                 filter containers.     
                           Abbreviated........  Cartridges and filters. 
------------------------------------------------------------------------

    (f) The use of any MSHA and Institute approval label obligates the 
applicant to whom it is issued to maintain or cause to be maintained 
the approved quality control sampling schedule and the acceptable 
quality level for each characteristic tested, and to assure that it is 
manufactured according to the drawings and specifications upon which 
the certificate of approval is based.
    (g) Each respirator, respirator component, and respirator container 
shall, as required by the Institute to assure quality control and 
proper use of the respirator, be labeled distinctly to show the name of 
the applicant, and the name and letters or numbers by which the 
respirator or respirator component is designated for trade purposes, 
and the lot number, serial number, or approximate date of manufacture.
Sec. 84.1130  Respirators; description.

    (a) Dust, fume, and mist respirators, including all completely 
assembled respirators designed for use as respiratory protection during 
entry into and escape from atmospheres which contain adequate oxygen to 
support life and hazardous particulates, are described as follows:
    (1) Air-purifying respirators, either with replaceable or reusable 
filters, designed as respiratory protection against dusts:
    (i) Having an air contamination level not less than 0.05 milligram 
per cubic meter of air, including but not limited to coal, arsenic, 
cadmium, chromium, lead, and manganese; or
    (ii) Having an air contamination level not less than 2 million 
particles per cubic foot of air, including but not limited to aluminum, 
flour, iron ore, and free silica, resulting principally from the 
disintegration of a solid, e.g., dust clouds produced in mining, 
[[Page 30389]] quarrying, and tunneling, and in dusts produced during 
industrial operations, such as grinding, crushing, and the general 
processing of minerals and other materials.
    (2) Air-purifying respirators, with replaceable filters, designed 
as respiratory protection against fumes of various metals having an air 
contamination level not less than 0.05 milligram per cubic meter, 
including but not limited to aluminum, antimony, arsenic, cadmium, 
chromium, copper, iron, lead, magnesium, manganese, mercury (except 
mercury vapor), and zinc, which result from the sublimation or 
condensation of their respective vapors, or from the chemical reaction 
between their respective vapors and gases.
    (3) Air-purifying respirators, with replaceable filters, designed 
as respiratory protection against mists of materials having an air 
contamination level not less than 0.05 milligram per cubic meter or 2 
million particles per cubic foot, e.g., mists produced by spray coating 
with vitreous enamels, chromic acid mist produced during chromium 
plating, and other mists of materials whose liquid vehicle does not 
produce harmful gases or vapors.
    (4) Air-purifying respirators, with replaceable filters, designed 
as respiratory protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter, including 
but not limited to lithium hydride and beryllium, and against 
radionuclides.
    (5) Air-purifying respirators, with replaceable filters, designed 
as respiratory protection against radon daughters, and radon daughters 
attached to dusts, fumes, and mists.
    (6) Air-purifying respirators, with replaceable filters, designed 
as respiratory protection against asbestos-containing dusts and mists.
    (7) Air-purifying respirators, with replaceable filters, designed 
as protection against various combinations of particulate matter.
    (8) Air-purifying dust respirators designed as respiratory 
protection against pneumoconiosis- and fibrosis-producing dusts, or 
dusts and mists, including but not limited to aluminum, asbestos, coal, 
flour, iron ore, and free silica.
    (b) Gas masks containing filters for protection against dusts, 
fumes, mists, and smokes in combination with gases, vapors, or gases 
and vapors. These respirators are not for use against gases or vapors 
with poor warning properties (except where MSHA or Occupational Safety 
and Health Administration standards may permit such use for a specific 
gas or vapor) or those which generate high heats of reaction with 
sorbent material in the canister.
    (c) Pesticide respirators, including all completely assembled 
respirators which are designed for use as respiratory protection during 
entry into and escape from atmospheres which contain pesticide hazards, 
are described according to their construction as follows:
    (1) Front-mounted or back-mounted gas masks;
    (2) Chin-style gas mask;
    (3) Chemical cartridge;
    (4) Air-purifying respirator with attached blower; and,
    (5) Other devices, including combination respirators.
    (d) Respirators with cartridges containing or having attached to 
them, filters for protection against mists of paints, lacquers, and 
enamels. These respirators are not for use against gases or vapors with 
poor warning properties (except where MSHA or Occupational Safety and 
Health Administration standards may permit such use for a specific gas 
or vapor) or those which generate high heats of reaction with sorbent 
material in the cartridge.
    (e) Respirators with cartridges containing or having attached to 
them filters for protection against dusts, fumes, and mists, except the 
mists of paints, lacquers, and enamels. These respirators are not for 
use against gases or vapors with poor warning properties (except where 
MSHA or Occupational Safety and Health Administration standards may 
permit such use for a specific gas or vapor) or those which generate 
high heats of reaction with sorbent material in the cartridge.


Sec. 84.1131  Respirators; required components.

    (a) Each respirator described in Sec. 84.1130 shall, where its 
design requires, contain the following component parts:
    (1) Facepiece, mouthpiece with noseclip, hood, or helmet;
    (2) Filter unit, canister with filter, or cartridge with filter;
    (3) Harness;
    (4) Attached blower; and
    (5) Breathing tube.
    (b) The components of each respirator shall meet the minimum 
construction requirements set forth in Subpart G of this part.


Sec. 84.1132  Breathing tubes; minimum requirements.

    (a) Flexible breathing tubes used in conjunction with respirators 
shall be designed and constructed to prevent:
    (1) Restriction of free head movement;
    (2) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (3) Interference with the wearer's activities; and
    (4) Shutoff of airflow due to kinking, or from chin or arm 
pressure.


Sec. 84.1133  Harnesses; installation and construction; minimum 
requirements.

    (a) Each respirator shall, where necessary, be equipped with a 
suitable harness designed and constructed to hold the components of the 
respirator in position against the wearer's body.
    (b) Harnesses shall be designed and constructed to permit easy 
removal and replacement of respirator parts, and, where applicable, 
provide for holding a full facepiece in the ready position when not in 
use.


Sec. 84.1134  Respirator containers; minimum requirements.

    (a) Except as provided in paragraph (b) of this section each 
respirator shall be equipped with a substantial, durable container 
bearing markings which show the applicant's name, the type of 
respirator it contains, and all appropriate approval labels. Except for 
dust, fume, and mist respirators, the commercial designation of the 
respirator it contains shall be shown.
    (b) Containers for single-use respirators may provide for storage 
of more than one respirator, however, such containers shall be designed 
and constructed to prevent contamination of respirators which are not 
removed, and to prevent damage to respirators during transit.
    (c) Containers for gas masks combinations shall be designed and 
constructed to permit easy removal of the mask.


Sec. 84.1135  Half-mask facepieces, full facepieces, hoods, helmets, 
and mouthpieces; fit; minimum requirements.

    (a) Half-mask facepieces and full facepieces shall be designed and 
constructed to fit persons with various facial shapes and sizes either:
    (1) By providing more than one facepiece size; or
    (2) By providing one facepiece size which will fit varying facial 
shapes and sizes.
    (b) Full facepieces shall provide for optional use of corrective 
spectacles or lenses, which shall not reduce the respiratory protective 
qualities of the respirator.
    (c) Hoods and helmets shall be designed and constructed to fit 
persons with various head sizes, provide for the optional use of 
corrective spectacles or lenses, and insure against any restriction of 
movement by the wearer. [[Page 30390]] 
    (d) Mouthpieces shall be equipped with noseclips which are securely 
attached to the mouthpiece or respirator and provide an airtight seal.
    (e) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.
    (f) Half-mask facepieces shall not interfere with the fit of common 
industrial safety corrective spectacles, as determined by the 
Institute's facepiece tests in Secs. 84.1141, 84.1142, and 84.1156(b).


Sec. 84.1136  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.

    (a) Facepieces, hoods, and helmets shall be designed and 
constructed to provide adequate vision which is not distorted by the 
eyepieces.
    (b) All eyepieces of gas masks combinations shall be designed and 
constructed to be impact and penetration resistant. Federal 
Specification, Mask, Air Line: and Respirator, Air Filtering, 
Industrial, GGG-M-125d, October 11, 1965, with interim amendment-1, 
July 30, 1969, is an example of an appropriate standard for determining 
impact and penetration resistance. Copies of GGG-M-125d may be obtained 
from the NIOSH, Certification and Quality Assurance Branch, 1095 
Willowdale Road, Morgantown, WV 26505-2888.


Sec. 84.1137  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be protected against 
distortion.
    (b) Inhalation valves shall be designed and constructed and 
provided where necessary to prevent excessive exhaled air from 
adversely affecting filters, cartridges, and canisters, except where 
filters of dust, fume, and mist respirators are specifically designed 
to resist moisture as prescribed in Sec. 84.1145.
    (c) Exhalation valves shall be:
    (1) Provided where necessary;
    (2) Protected against damage and external influence; and
    (3) Designed and constructed to prevent inward leakage of 
contaminated air.


Sec. 84.1138  Head harnesses; minimum requirements.

    (a) All facepieces shall be equipped with head harnesses designed 
and constructed to provide adequate tension during use and an even 
distribution of pressure over the entire area in contact with the face.
    (b) Facepiece head harnesses, except those employed on single-use 
dust, fume, and mist respirators, shall be adjustable and replaceable.
    (c) Mouthpieces shall be equipped, where applicable, with 
adjustable and replaceable harnesses, designed and constructed to hold 
the mouthpiece in place.


Sec. 84.1139  Air velocity and noise levels; hoods and helmets; minimum 
requirements.

    Noise levels generated by the respirator will be measured inside 
the hood or helmet at maximum airflow obtainable and shall not exceed 
80 dBA.


Sec. 84.1140  Dust, fume, and mist respirators; performance 
requirements; general.

    Dust, fume, and mist respirators and the individual components of 
each such device shall, as appropriate, meet the requirements for 
performance and protection specified in the tests described in 
Secs. 84.1141 through 84.1152 and prescribed in Tables 12 and 13.


Sec. 84.1141  Isoamyl acetate tightness test; dust, fume, and mist 
respirators designed for respiratory protection against fumes of 
various metals having an air contamination level not less than 0.05 
milligram per cubic meter; minimum requirements.

    (a) The respirator will be modified in such a manner that all of 
the air that normally would be inhaled through the inhalation port(s) 
is drawn through an efficient activated charcoal-filled canister, or 
cartridge(s), without interference with the face-contacting portion of 
the facepiece.
    (b) The modified respirator will be worn by persons for at least 2 
minutes each in a test chamber containing 100 parts (by volume) of 
isoamyl-acetate vapor per million parts of air.
    (c) The odor of isoamyl-acetate shall not be detected by the 
wearers of the modified respirator while in the test atmosphere.


Sec. 84.1142  Isoamyl acetate tightness test; respirators designed for 
respiratory protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter, or 
against radionuclides; minimum requirements.

    (a) The applicant shall provide a charcoal-filled canister or 
cartridge of a size and resistance similar to the filter unit with 
connectors which can be attached to the facepiece in the same manner as 
the filter unit.
    (b)(1) The canister or cartridge will be used in place of the 
filter unit, and persons will each wear a modified half-mask facepiece 
for 5 minutes in a test chamber containing 100 parts (by volume) of 
isoamyl-acetate vapor per million parts of air.
    (2) The following work schedule will be performed by each wearer in 
the test chamber:
    (i) Two minutes walking, nodding, and shaking head in normal 
movements; and
    (ii) Three minutes exercising and running in place.
    (3) The facepiece shall be capable of adjustment, according to the 
applicant's instructions, to each wearer's face, and the odor of 
isoamyl-acetate shall not be detectable by any wearer during the test.
    (c) Where the respirator is equipped with a full facepiece, hood, 
helmet, or mouthpiece, the canister or cartridge will be used in place 
of the filter unit, and persons will each wear the modified 
respiratory-inlet covering for 5 minutes in a test chamber containing 
1,000 parts (by volume) of isoamyl-acetate vapor per million parts of 
air, performing the work schedule specified in paragraph (b)(2) of this 
section.


Sec. 84.1143  Dust, fume, and mist air-purifying filter tests; 
performance requirements; general.

    Dust, fume, and mist respirators will be tested in accordance with 
the schedule set forth in Table 13 of this subpart to determine their 
effectiveness as protection against the particulate hazards specified 
in Table 13.


Sec. 84.1144  Silica dust test for dust, fume, and mist respirators; 
single-use or reusable filters; minimum requirements.

    (a) Three non-powered respirators with single-use filters will be 
tested for periods of 90 minutes each at a continuous airflow rate of 
32 liters per minute.
    (b) The relative humidity in the test chamber will be 20-80 
percent, and the room temperature approximately 25 deg. C.
    (c) The test suspension in the chamber will not be less than 50 nor 
more than 60 milligrams of flint (99+ percent free silica) per cubic 
meter of air.
    (d) The flint in suspension will be ground to pass 99+ percent 
through a 270-mesh sieve.
    (e) The particle-size distribution of the test suspension will have 
a geometric mean of 0.4 to 0.6 micrometer, and the standard geometric 
deviation will not exceed 2.
    (f) The total amount of unretained test suspension in samples taken 
during testing shall not exceed 1.5 milligrams for a non-powered air-
purifying respirator.
    (g) Three non-powered respirators with reusable filters will be 
tested and shall meet the requirements specified in paragraphs (a) 
through (f) of this section; each filter shall be tested three times: 
Once as received; once after cleaning; and once after recleaning. The 
applicant's instructions shall be followed for each cleaning. 
[[Page 30391]] 


Sec. 84.1145  Silica dust test; non-powered single-use dust 
respirators; minimum requirements.

    (a) Three respirators will be tested.
    (b) As described in Sec. 84.1144, airflow will be cycled through 
the respirator by a breathing machine at the rate of 24 respirations 
per minute with a minute volume of 40 liters; a breathing machine cam 
with a work rate of 622 kg.-m.2/minute shall be used.
    (c) Air exhaled through the respirator will be 35 deg. 
<plus-minus>2 deg. C. with 94 <plus-minus>3 percent relative humidity. 
#
    (d) Air inhaled through the respirator will be sampled and analyzed 
for respirator leakage.
    (e) The total amount of unretained test suspension, after drying, 
in samples taken during testing, shall not exceed 1.8 milligrams for 
any single test.


Sec. 84.1146  Lead fume test for dust, fume, and mist respirators; 
minimum requirements.

    (a) Three non-powered respirators will be tested for a period of 
312 minutes each at a continuous airflow rate of 32 liters per minute.
    (b) The relative humidity in the test chamber will be 20-80 
percent, and the room temperature approximately 25 deg. C.
    (c) The test suspension in the test chamber will not be less than 
15 nor more than 20 milligrams of freshly generated lead-oxide fume, 
calculated as lead (Pb), per cubic meter of air.
    (d) The fume will be generated by impinging an oxygen-gas flame on 
molten lead.
    (e) Samples of the test suspension will be taken during each test 
period for analysis.
    (f) The total amount of unretained test suspension in the samples 
taken during testing, which is analyzed and calculated as lead (Pb), 
shall not exceed 1.5 milligrams of lead for a non-powered air-purifying 
respirator.
Sec. 84.1147  Silica mist test for dust, fume, and mist respirators; 
minimum requirements.

    (a) Three non-powered respirators will be tested for a period of 
312 minutes each at a continuous airflow rate of 32 liters per minute.
    (b) The room temperature in the test chamber will be approximately 
25 deg.C.
    (c) The test suspension in the test chamber will not be less than 
20 nor more than 25 milligrams of silica mist, weighed as silica dust, 
per cubic meter of air.
    (d) Mist will be produced by spraying an aqueous suspension of 
flint (99+ percent free silica), and the flint shall be ground to pass 
99+ percent through a 270-mesh sieve.
    (e) Samples of the test suspension will be taken during each test 
period for analysis.
    (f) The total amount of silica mist unretained in the samples taken 
during testing, weighed as silica dust, shall not exceed 2.5 milligrams 
for a non-powered air-purifying respirator.


Sec. 84.1148  Tests for respirators designed for respiratory protection 
against more than one type of dispersoid; minimum requirements.

    Respirators designed as respiratory protection against more than 
one particulate hazard (dust, fume, or mist) shall comply with all the 
requirements of this part, with respect to each of the specific hazards 
involved.


Sec. 84.1149  Airflow resistance tests; all dust, fume, and mist 
respirators; minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a dust, fume, or mist respirator mounted 
on a test fixture with air flowing at a continuous rate of 85 liters 
per minute, both before and after each test conducted in accordance 
with Secs. 84.1144 through 84.1147.
    (b) The maximum allowable resistance requirements for dust, fume, 
and mist respirators are as follows:

                           Maximum Resistance                           
                        [mm. water-column height]                       
------------------------------------------------------------------------
                                     Initial       Final                
        Type of respirator          inhalation   inhalation   Exhalation
------------------------------------------------------------------------
Pneumoconiosis- and fibrosis-                                           
 producing dusts, or dusts and                                          
 mists...........................           12           15           15
Dust, fume, and mist, with single-                                      
 use filter......................           30           50           20
Dust, fume, and mist, with                                              
 reusable filter.................           20           40           20
Radon daughter...................           18       \1\ 25           15
Asbestos dust and mist...........           18           25          15 
------------------------------------------------------------------------
\1\ Measured after silica dust test described in Sec.  84.1144.         

Sec. 84.1150  Exhalation valve leakage test; minimum requirements.

    (a) Dry exhalation valves and valve seats will be subjected to a 
suction of 25 mm. water-column height while in a normal operating 
position.
    (b) Leakage between the valve and valve seat shall not exceed 30 
milliliters per minute.


Sec. 84.1151  DOP filter test; respirators designed as respiratory 
protection against dusts, fumes, and mists having an air contamination 
level less than 0.05 milligram per cubic meter and against 
radionuclides; minimum requirements.

    (a) All single air-purifying respirator filter units will be tested 
in an atmosphere concentration of 100 micrograms of DOP per liter of 
air at continuous flow rates of 32 and 85 liters per minute for a 
period of 5 to 10 seconds.
    (b) Where filters are to be used in pairs, the flow rates will be 
16 and 42.5 liters per minute, respectively, through each filter.
    (c) The filter will be mounted on a connector in the same manner as 
used on the respirator, and the total leakage for the connector and 
filter shall not exceed 0.03 percent of the ambient DOP concentration 
at either flow rate.


Sec. 84.1152  Silica dust loading test; respirators designed as 
protection against dusts, fumes, and mists having an air contamination 
level less than 0.05 milligram per cubic meter and against 
radionuclides; minimum requirements.

    (a) Three non-powered respirators will be tested in accordance with 
the provisions of Sec. 84.1144, or equivalent, and shall meet the 
minimum requirements of Secs. 84.1144 and 84.1149.
    (b) Three powered air-purifying respirators will be tested in 
accordance with the provisions of Sec. 84.1144 except they will be 
tested for a period of 4 hours each at a flowrate not less than 115 
liters per minute to tight-fitting facepieces, and not less than 170 
liters per minute to loose-fitting hoods and helmets. The total amount 
of unretained test suspension in samples taken during testing shall not 
exceed 14.4 milligrams for a powered air-purifying respirator with 
tight-fitting facepiece, and 21.3 milligrams for a powered air-
purifying respirator with loose-fitting hood or helmet. They shall meet 
the minimum requirements of Sec. 84.1149.

[[Page 30392]]

Sec. 84.1153  Dust, fume, mist, and smoke tests; canister bench tests; 
gas masks canisters containing filters; minimum requirements.

    (a) Gas mask canisters containing filters for protection against 
dusts, fumes, mists, and smokes in combination with gases, vapors, or 
gases and vapors, will be tested as prescribed in Sec. 84.1140 except 
for the breathing resistance which will be in accordance with 
Sec. 84.122.
    (b) Gas mask canisters designed for protection against smokes will 
be tested in an atmospheric concentration of 100 micrograms of dioctyl 
phthalate per liter of air at continuous flow rates of 32 liters per 
minute and 85 liters per minute for a period of 5 to 10 seconds, and 
the DOP leakage through the canister shall not exceed 0.03 percent of 
the test concentration.
    (c) Gas mask canisters containing filters for protection against 
dusts, fumes, mists, and smokes in combination with gases, vapors, or 
gases and vapors, will be tested as prescribed in Sec. 84.126.


Sec. 84.1154  Canister and cartridge requirements.

    (a) Where two or more canisters or cartridges are used in parallel, 
their resistance to airflow shall be essentially equal.
    (b) The color and markings of all canisters and cartridges or 
labels shall conform with the requirements of the American National 
Standards Institute, American National Standard for Identification of 
Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. 
ANSI K13.1 is incorporated by reference and has been approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. Copies may be obtained from American National Standards 
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be 
inspected at the NIOSH, Certification and Quality Assurance Branch, 
1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC.


Sec. 84.1155  Filters used with canisters and cartridges; location; 
replacement.

    (a) Particulate matter filters used in conjunction with a canister 
or cartridge shall be located on the inlet side of the canister or 
cartridge.
    (b) Filters shall be incorporated into or firmly attached to the 
canister or cartridge and each filter assembly shall, where applicable, 
be designed to permit its easy removal from and replacement on the 
canister or cartridge.


Sec. 84.1156  Pesticide respirators; performance requirements; general.

    Pesticide respirators and the individual components of each such 
device shall, as appropriate, meet the following minimum requirements 
for performance and protection:
    (a) Breathing resistance test. (1) Airflow resistance will be 
measured in the facepiece, mouthpiece, hood, or helmet of a pesticide 
respirator mounted on a test fixture with air flowing at a continuous 
rate of 85 liters per minute, both before and after each test conducted 
in accordance with paragraphs (c) and (f) of this section.
    (2) The maximum allowable resistance requirements for pesticide 
respirators are as follows:

                           Maximum Resistance                           
                        [mm. water-column height]                       
------------------------------------------------------------------------
                                          Inhalation                    
   Type of pesticide respirator   --------------------------  Exhalation
                                     Initial     Final \1\              
------------------------------------------------------------------------
Front- or back-mounted gas mask..           70           85           20
Chin-style gas mask..............           65           80           20
Powered air-purifying \2\........       \2\ 50       \2\ 70           20
Chemical Cartridge...............           50           70           20
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Table 14 of this   
  subpart.                                                              
\2\ Resistance of filter(s), cartridge(s), and breathing tube(s) only   
  with blower not operating.                                            

    (b) Facepiece test. (1) The complete pesticide respirator will be 
fitted to the faces of persons having varying facial shapes and sizes.
    (2) Where the applicant specifies a facepiece size or sizes for his 
respirator together with the approximate measurements of faces they are 
designed to fit, the Institute will provide test subjects to suit such 
facial measurements.
    (3) Any pesticide respirator part which must be removed to perform 
the facepiece fit test shall be replaceable without special tools and 
without disturbing facepiece fit.
    (4) The facepiece or mouthpiece fit test using positive or negative 
pressure recommended by the applicant and described in his instructions 
will be used during each test.
    (5)(i) Each wearer will enter a chamber containing 1,000 p.p.m. 
isoamyl-acetate vapor for a respirator equipped with a full facepiece, 
mouthpiece, hood, or helmet and 100 p.p.m. isoamyl-acetate vapor for a 
respirator equipped with a half-mask facepiece.
    (ii) The facepiece, mouthpiece, hood, or helmet may be adjusted, if 
necessary, in the test chamber before starting the test.
    (iii) Each wearer will remain in the chamber while performing the 
following activities:
    (A) Two minutes, nodding and turning head;
    (B) Two minutes, calisthenic arm movements;
    (C) Two minutes, running in place; and
    (D) Two minutes, pumping with a tire pump into a 28-liter (1 cubic 
foot) container.
    (iv) Each wearer shall not detect the odor of isoamyl-acetate 
during the test.
    (c) Silica dust test. Three completely assembled pesticide 
respirators will be tested with a mechanical-testing apparatus as 
follows:
    (1) Temperature in the test chamber will be approximately 25 deg. 
C.
    (2) Continuous airflow through the respirator will be 32 liters per 
minute for front-mounted, back-mounted, and chin-style gas mask 
pesticide respirators and chemical cartridge pesticide respirators, and 
not less than 115 (4 cubic feet) liters per minute to tight-fitting 
facepieces and 170 liters (6 cubic feet) per minute to loose-fitting 
hoods and helmets of powered air-purifying respirators. [[Page 30393]] 
    (3) The test aerosol will contain 50-60 milligrams of 99+ percent 
free silica per cubic meter of air.
    (4) The particle size distribution of the test suspension will have 
a geometric mean diameter of 0.4 to 0.6 micrometer, with a standard 
geometric deviation less than 2.
    (5) Front-mounted, back-mounted, and chin-style gas mask pesticide 
respirators and chemical cartridge pesticide respirators will be tested 
for 90 minutes and powered air-purifying respirators will be tested for 
4 hours.
    (d) Lead fume test. Three completely assembled pesticide 
respirators will be tested with a mechanical-testing apparatus as 
follows:
    (1) Continuous airflow through the respirator will be 32 liters per 
minute for front-mounted, back-mounted, and chin-style gas mask 
pesticide respirators and chemical cartridge pesticide respirators and 
not less than 115 liters (4 cubic feet) per minute, for powered air-
purifying respirators with tight-fitting facepieces, and not less than 
170 liters (6 cubic feet) per minute for powered air-purifying 
respirators with loose-fitting hoods and helmets.
    (2) The test aerosol will contain 15-20 milligrams of freshly 
generated lead-oxide fume, calculated as lead, per cubic meter of air.
    (3) The fume will be generated by impinging an oxygen-gas flame on 
molten lead.
    (4) Front-mounted, back-mounted, and chin-style gas mask pesticide 
respirators and chemical cartridge pesticide respirators will be tested 
for 90 minutes and powered air-purifying pesticide respirators will be 
tested for 4 hours.
    (5) The total amount of unretained test suspension, which is 
analyzed and calculated as lead, shall not exceed:
    (i) 0.43 milligram for any 90-minute test;
    (ii) 4.8 milligrams for any 4-hour test made at 115 liters (4 cubic 
feet) per minute; or
    (iii) 6.2 milligrams for any 4-hour test made at 170 liters (6 
cubic feet) per minute.
    (e) Dioctyl-phthalate test. (1) All canisters submitted for use 
with front-mounted and back-mounted gas mask pesticide respirators will 
be tested in an atmospheric concentration of 100 micrograms of dioctyl-
phthalate per liter of air at continuous flow rates of 32 and 85 liters 
per minute for a test period of 5 to 10 seconds.
    (2) The DOP leakage through the canister shall not exceed 0.03 
percent of the ambient DOP concentration.
    (f) Bench tests for pesticide respirators. (1)(i) Bench tests will 
be made on an apparatus that allows the test atmosphere at 
50<plus-minus>5 percent relative humidity and at room temperature 
(25 deg.<plus-minus>2.5 deg. C.) to enter the canister or cartridge at 
predetermined concentrations and rates of flow, and that has a means 
for determining the test life of the canister or cartridge against 
carbon tetrachloride.
    (ii) Canisters and cartridges will be tested as they are used on 
each pesticide respirator, either singly or in pairs.
    (iii) Three canisters or cartridges or pairs of cartridges will be 
removed from containers and tested as received from the applicant.
    (iv) Two canisters, cartridges, or pairs of cartridges will be 
equilibrated at room temperature by passing 25 percent relative 
humidity air through them at the following flow rates (expressed as 
liters per minute (l.p.m.)) for 6 hours:

------------------------------------------------------------------------
                                                               Airflow  
               Type of canister or cartridge                 rate,l.p.m.
------------------------------------------------------------------------
Air-purifying canister.....................................          64 
Air-purifying cartridge....................................          25 
Powered air-purifying with tight-fitting facepiece.........         115 
Powered air-purifying with loose-fitting hood or helmet....         170 
------------------------------------------------------------------------

    (v) Two canisters, cartridges, or pairs of cartridges will be 
equilibrated at room temperature by passing 85 percent relative 
humidity air through them at the flow rates stated in paragraph 
(f)(1)(iv) of this section for 6 hours.
    (vi) The equilibrated canisters or cartridges will be resealed, 
kept in an upright position at room temperature, and tested within 18 
hours.
    (2) Canisters and cartridges tested in accordance with the 
provisions of this section shall meet the requirements specified in 
Table 14 of this subpart.
Sec. 84.1157   Chemical cartridge respirators with particulate filters; 
performance requirements; general.

    Chemical cartridge respirators with particulate filters and the 
individual components of each such device shall, as appropriate, meet 
the following minimum requirements for performance and protection:
    (a) Breathing resistance test. (1) Resistance to airflow will be 
measured in the facepiece, mouthpiece, hood, or helmet of a chemical 
cartridge respirator mounted on a test fixture with air flowing at a 
continuous rate of 85 liters per minute, both before and after each 
test conducted in accordance with paragraphs (d) through (f) of this 
section.
    (2) The maximum allowable resistance requirements for chemical 
cartridge respirators are as follows:

                           Maximum Resistance                           
                        [mm. water-column height]                       
------------------------------------------------------------------------
                                          Inhalation                    
    Type of chemical cartridge    --------------------------  Exhalation
            respirator               Initial     Final \1\              
------------------------------------------------------------------------
For gases, vapors, or gases and                                         
 vapors, and dusts, fumes, and                                          
 mists...........................           50           70           20
For gases, vapors, or gases and                                         
 vapors, and mists of paints,                                           
 lacquers, and enamels...........           50           70           20
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 in subpart L  
  of this part.                                                         

    (b) Facepiece test. The facepiece test will be conducted as 
specified in Sec. 84.205.
    (c) Lacquer and enamel mist tests; general. (1) Three respirators 
with cartridges containing or having attached to them, filters for 
protection against mists of paints, lacquers, and enamels shall be 
tested in accordance with the provisions of paragraph (f) of this 
section.
    (2) In addition to the test requirements set forth in paragraph 
(c)(1) of this section, three such respirators will be tested against 
each aerosol in accordance with the provisions of paragraphs (d) and 
(e) of this section.
    (d) Lacquer mist test. (1) Temperature in the test chamber will be 
approximately 25 deg. C.
    (2) Continuous airflow through the respirator will be 32 liters per 
minute for air-purifying respirators, and not less than 115 liters per 
minute to tight fitting facepieces and 170 liters per minute to 
[[Page 30394]] loose-fitting hoods and helmets of powered air-purifying 
respirators.
    (3) Airflow through the chamber will be 20-25 air changes per 
minute.
    (4) The atomizer employed will be a No. 64-5 nozzle with setup 3, 
or equivalent, operating at 69 kN/m.\2\ (10 pounds per square inch 
gage).
    (5) The test aerosol will be prepared by atomizing a mixture of one 
volume of clear cellulose nitrate lacquer and one volume of lacquer 
thinner. The lacquer described in Federal Specification TT-L-31, 
October 7, 1953, is an example of an acceptable lacquer. Copies of TT-
L-31 may be inspected or obtained from the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
    (6) The concentration of cellulose nitrate in the test aerosol will 
be 95-125 milligrams per cubic meter.
    (7) The test aerosol will be drawn to each respirator for a total 
of 156 minutes for air-purifying respirators and 240 minutes for 
powered air-purifying respirators.
    (8) The total amount of unretained mist in the samples taken during 
testing, weighed as cellulose nitrate, shall not exceed 5 milligrams 
for an air-purifying respirator, 28 milligrams for a powered air-
purifying respirator with tight-fitting facepiece, and 41 milligrams 
for a powered air-purifying respirator with loose-fitting hood or 
helmet.
    (e) Enamel mist test. (1) Temperature in the test chamber will be 
approximately 25 deg. C.
    (2) Continuous airflow through the respirator will be 32 liters per 
minute for air-purifying respirators, and not less than 115 liters per 
minute to tight-fitting facepieces and 170 liters per minute to loose-
fitting hoods and helmets of powered air-purifying respirators.
    (3) Airflow through the chamber will be 20-25 air changes per 
minute.
    (4) The atomizer employed will be a No. 64 nozzle with setup 1A, or 
equivalent, operating at 69 kN/m.<SUP>2 (10 pounds per square inch 
gage).
    (5) The test aerosol will be prepared by atomizing a mixture of 1 
volume of white enamel and 1 volume of turpentine. The enamel described 
in Federal Specification TT-E-489b, May 12, 1953, with amendment-1 of 9 
November 1955 is an example of an acceptable enamel. Copies of TT-E-
489b may be inspected or obtained from the NIOSH, Certification and 
Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-
2888.
    (6) The concentration of pigment in the test aerosol, weighed as 
ash, will be 95-125 milligrams per cubic meter.
    (7) The test aerosol will be drawn to each respirator for a total 
of 156 minutes for air-purifying respirators and 240 minutes for power 
air-purifying respirators.
    (8) The total amount of unretained mist in the samples taken during 
testing, weighed as ash, shall not exceed 1.5 milligrams for any air-
purifying respirator, 8.3 milligrams for a powered air-purifying 
respirator with tight-fitting facepiece, and 12.3 milligrams for a 
powered air-purifying respirator with loose-fitting hood or helmet.
    (f) Bench tests; gas and vapor tests. (1) Bench tests will be made 
in accordance with Sec. 84.207 and tested cartridges shall meet the 
minimum requirements set forth in Table 11 of subpart L of this part. 
Cartridges will be equilibrated in accordance with paragraph (f)(2) of 
this section.
    (2)(i) Two powered air-purifying cartridges or pairs of cartridges 
will be equilibrated at room temperature by passing 25 percent relative 
humidity air through them at the following flow rates (expressed in 
liters per minute (l.p.m.)) for 6 hours:

------------------------------------------------------------------------
                                                               Airflow  
                     Type of cartridge                       rate,l.p.m.
------------------------------------------------------------------------
Powered air purifying with tight-fitting facepiece.........         115 
Powered air purifying with loose-fitting hood or helmet....         170 
------------------------------------------------------------------------

    (ii) Two powered air-purifying cartridges or pairs of cartridges 
will be equilibrated by passing 85 percent relative humidity air 
through them at the flow rates stated in paragraph (f)(2)(i) of this 
section.
    (iii) All cartridges will be resealed, kept in an upright position, 
at room temperatures, and tested within 18 hours.


Sec. 84.1158  Dust, fume, and mist tests; respirators with filters; 
minimum requirements; general.

    (a) Three respirators with cartridges containing, or having 
attached to them, filters for protection against dusts, fumes, and 
mists, except the mists of paints, lacquers, and enamels, will be 
tested in accordance with the provisions of Sec. 84.1157(f).
    (b) In addition to the test requirements set forth in paragraph (a) 
of this section, three such respirators will be tested, as appropriate, 
in accordance with the provisions of Secs. 84.1141 through 84.1152; 
however, the maximum allowable resistance of complete dust, fume, and 
mist, and gas, vapor, or gas and vapor chemical cartridge respirators 
shall not exceed the maximum allowable limits set forth in 
Sec. 84.1157(a)(2).

Tables to Subpart KK of Part 84

                 Table 12.--Facepiece Test Requirements                 
                      [42 CFR Part 84, Subpart KK]                      
------------------------------------------------------------------------
                                  Pressure       Isoamyl acetate test   
       Respirator types           tightness  ---------------------------
                                  test \1\       84.1141       84.1142  
------------------------------------------------------------------------
Dusts: Air Contamination Level                                          
 not less than 0.05 mg/M<SUP>3 or 2                                          
 mppcf........................            X                             
Fumes: Air Contamination Level                                          
 not less than 0.05 mg/M<SUP>3.....            X             X               
Mists: Air Contamination Level                                          
 not less than 0.05 mg/M<SUP>3 or 2                                          
 mppcf........................            X                             
Dusts, Fumes, and Mists: Air                                            
 Contamination Level less than                                          
 0.05 mg/M<SUP>3 or 2 mppcf, and                                             
 radionuclides................            X                           X 
Radon daughters...............            X             X               
Asbestos-containing dusts and                                           
 mists........................            X                             
------------------------------------------------------------------------
\1\ Test is required only where applicable.                             


                                                                        
[[Page 30395]]
        Table 13.--Air-Purifying and Powered Air-Purifying Respirator Filter Tests Required for Approval        
                                          [42 CFR Part 84, Subpart KK]                                          
----------------------------------------------------------------------------------------------------------------
                                          Silica dust tests                                                     
      Respirator types       ------------------------------------------   Lead fume    Silica mist    DOP test  
                                 84.1144       84.1145       84.1152    test 84.1146  test 84.1147     84.1151  
----------------------------------------------------------------------------------------------------------------
Dusts: Air Contamination                                                                                        
 Level not less than 0.05 mg/                                                                                   
 M<SUP>3 or 2 mppcf..............            X                                                                       
Fumes: Air Contamination                                                                                        
 Level not less than 0.05 mg/                                                                                   
 M<SUP>3.........................                                                      X                             
Mists: Air Contamination                                                                                        
 Level not less than 0.05 mg/                                                                                   
 M<SUP>3 or 2 mppcf..............                                                                    X               
Dusts, Fumes, and Mists: Air                                                                                    
 Contamination Level less                                                                                       
 than 0.05 mg/M<SUP>3 or 2 mppcf,                                                                                    
 and radionuclides..........                                        X                                         X 
Radon daughters.............          <SUP>1 X                                                     <SUP>2 X               
Asbestos-containing dusts                                                                                       
 and mists..................          <SUP>2 X                                                     <SUP>3 X               
Single use dust and mist                                                                                        
 respirators................                        <SUP>3 X                                       <SUP>3 X               
----------------------------------------------------------------------------------------------------------------
\1\ For resistance only.                                                                                        
\2\ For penetration only.                                                                                       
\3\ Test required only where applicable.                                                                        


    Table 14.--Carbon Tetrachloride Bench Tests and Requirements for    
                        Canisters and Cartridges                        
                      [42 CFR part 84, Subpart KK]                      
------------------------------------------------------------------------
                         Test                                  Minimum  
 Type of pesticide  concentration   Flow rate    Number of       life   
    respirator       p.p.m. CCl<INF>4      l.p.m.       tests       minutes<SUP>1 
------------------------------------------------------------------------
Chest-mounted or                                                        
 back-mounted gas                                                       
 mask (as                                                               
 received)........        20,000            64            3           12
Chest-mounted or                                                        
 back-mounted gas                                                       
 mask                                                                   
 (equilibrated)...        20,000            32            4           12
Chin-style gas                                                          
 mask (as                                                               
 received)........         5,000            64            3           12
Chin-style gas                                                          
 mask                                                                   
 (equilibrated)...         5,000            32            4           12
Chemical Cartridge                                                      
 respirator (as                                                         
 received)........         1,000            64            3           50
Chemical cartridge                                                      
 respirator                                                             
 (equilibrated)...         1,000            32            4           50
Powered air-                                                            
 purifying                                                              
 respirator (tight-                                                     
 fitting                                                                
 facepiece, as                                                          
 received)........         1,000         <SUP>2 115            3           50
Powered air-                                                            
 purifying                                                              
 respirator (tight-                                                     
 fitting                                                                
 facepiece,                                                             
 equilibrated)....         1,000         <SUP>2 115            4           25
Powered air-                                                            
 purifying                                                              
 respirator (loose-                                                     
 fitting hood or                                                        
 helmet, as                                                             
 received)........         1,000         <SUP>3 170            3           50
Powered air-                                                            
 purifying                                                              
 respirator (loose-                                                     
 fitting hood or                                                        
 helmet,                                                                
 equilibrated)....         1,000         <SUP>3 170            4           25
------------------------------------------------------------------------
\1\ Minimum life will be determined at 5 p.p.m. leakage.                
\2\ The flow rate shall be the effective flow rate of the device, but   
  shall be not less than 115 l.p.m.                                     
\3\ The flow rate shall be the effective flow rate of the device, but   
  shall be not less than 170 l.p.m.                                     

  Note: The following appendix will not appear in the Code of 
Federal Regulations.

    Appendix A to Preamble--Comparison of Final Rule to Proposed Rule   
------------------------------------------------------------------------
 Proposed      Final                                                    
  section     section             Change from proposal to final         
------------------------------------------------------------------------
84.1......      84.1    No change from proposal.                        
84.2......      84.2    No change from proposal.                        
84.3......              Incorporation by reference section is not       
                         included in the final rule because of format   
                         requirements of the Federal Register.          
84.4......      84.3    No change from proposal.                        
84.10.....      84.10   No change from proposal.                        
84.11.....      84.11   No change from proposal.                        
84.12.....      84.12   No change from proposal.                        
84.20.....      84.20   No change from proposal.                        
84.21.....      84.21   No change from proposal.                        
84.22.....      84.22   No change from proposal.                        
84.30.....      84.30   No change from proposal.                        
84.31.....      84.31   No change from proposal.                        
84.32.....      84.32   No change from proposal.                        
84.33.....      84.33   No change from proposal.                        
84.34.....      84.34   No change from proposal.                        
84.35.....      84.35   No change from proposal.                        
84.36.....      84.36   No change from proposal.                        
84.40.....      84.40   No change from proposal.                        
84.41.....      84.41   Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.42.....      84.42   No change from proposal.                        
84.43.....      84.43   No change from proposal.                        
84.50.....      84.50   No change from proposal.                        
84.51.....      84.51   No change from proposal.                        
84.52.....      84.52   No change from proposal.                        
[[Page 30396]]
                                                                        
84.53.....      84.53   No change from proposal.                        
84.60.....      84.60   No change from proposal.                        
84.61.....      84.61   No change from proposal.                        
84.62.....      84.62   No change from proposal.                        
84.63.....      84.63   No change from proposal.                        
84.64.....      84.64   No change from proposal.                        
84.65.....      84.65   No change from proposal.                        
84.66.....      84.66   No change from proposal.                        
84.70.....      84.70   No change from proposal.                        
84.71.....      84.71   No change from proposal.                        
84.72.....      84.72   No change from proposal.                        
84.73.....      84.73   No change from proposal.                        
84.74.....      84.74   No change from proposal.                        
84.75.....      84.75   No change from proposal.                        
84.76.....      84.76   Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.77.....      84.77   No change from proposal.                        
84.78.....      84.78   No change from proposal.                        
84.79.....      84.79   Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.80.....      84.80   No change from proposal.                        
84.81.....      84.81   Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.82.....      84.82   No change from proposal.                        
84.83.....      84.83   No change from proposal.                        
84.84.....      84.84   No change from proposal.                        
84.85.....      84.85   No change from proposal.                        
84.86.....      84.86   No change from proposal.                        
84.87.....      84.87   No change from proposal.                        
84.88.....      84.88   Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.89.....      84.89   No change from proposal.                        
84.90.....      84.90   No change from proposal.                        
84.91.....      84.91   No change from proposal.                        
84.92.....      84.92   No change from proposal.                        
84.93.....      84.93   No change from proposal.                        
84.94.....      84.94   No change from proposal.                        
84.95.....      84.95   No change from proposal.                        
84.96.....      84.96   No change from proposal.                        
84.97.....      84.97   Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.98.....      84.98   No change from proposal.                        
84.99.....      84.99   No change from proposal.                        
84.100....      84.100  No change from proposal.                        
84.101....      84.101  No change from proposal.                        
84.102....      84.102  No change from proposal.                        
84.103....      84.103  No change from proposal.                        
84.104....      84.104  No change from proposal.                        
84.110....      84.110  No change from proposal.                        
84.111....      84.111  No change from proposal.                        
84.112....      84.112  No change from proposal.                        
84.113....      84.113  Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.114....      84.114  No change from proposal.                        
84.115....      84.115  No change from proposal.                        
84.116....      84.116  No change from proposal.                        
84.117....      84.117  No change from proposal.                        
84.118....      84.118  No change from proposal.                        
84.119....      84.119  Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.120....      84.120  No change from proposal.                        
84.121....      84.121  No change from proposal.                        
84.122....      84.122  No change from proposal.                        
84.123....      84.123  No change from proposal.                        
84.124....      84.124  No change from proposal.                        
84.125....      84.125  No change from proposal.                        
84.126....      84.126  No change from proposal.                        
84.130....      84.130  No change from proposal.                        
84.131....      84.131  No change from proposal.                        
84.132....      84.132  No change from proposal.                        
84.133....      84.133  No change from proposal.                        
84.134....      84.134  No change from proposal.                        
84.135....      84.135  No change from proposal.                        
84.136....      84.136  Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.137....      84.137  No change from proposal.                        
84.138....      84.138  No change from proposal.                        
84.139....      84.139  No change from proposal.                        
84.140....      84.140  No change from proposal.                        
[[Page 30397]]
                                                                        
84.141....      84.141  Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.142....      84.142  No change from proposal.                        
84.143....      84.143  No change from proposal.                        
84.144....      84.144  No change from proposal.                        
84.145....      84.145  No change from proposal.                        
84.146....      84.146  No change from proposal.                        
84.147....      84.147  No change from proposal.                        
84.148....      84.148  No change from proposal.                        
84.149....      84.159  No change from proposal.                        
84.150....      84.150  No change from proposal.                        
84.151....      84.151  No change from proposal.                        
84.152....      84.152  No change from proposal.                        
84.153....      84.153  No change from proposal.                        
84.154....      84.154  No change from proposal.                        
84.155....      84.155  No change from proposal.                        
84.156....      84.156  No change from proposal.                        
84.157....      84.157  No change from proposal.                        
84.158....      84.158  No change from proposal.                        
84.159....      84.159  No change from proposal.                        
84.160....      84.160  No change from proposal.                        
84.161....      84.161  No change from proposal.                        
84.162....      84.162  No change from proposal.                        
84.163....      84.163  No change from proposal.                        
84.170....      84.170  1. Changed to limit requirements to non-powered 
                         air-purifying respirators. Added description of
                         non-powered air-purifying respirator.          
                        2. Changed classification from ``solid'' and    
                         ``liquid and solid'' to ``N-series, R-series,  
                         and P-series.''                                
                        3. Changed efficiency level designations from A 
                         (99.97%), B(99%), and C (95%) to N100, R100,   
                         P100 (99.97%), N99, R99, P99(99%), N95, R95,   
                         and P95(95%).                                  
84.171....      84.171  Changed to limit requirements to non-powered air-
                         purifying respirators.                         
84.172....      84.172  No change from proposal.                        
84.173....      84.173  No change from proposal.                        
84.174....      84.174  No change from proposal.                        
84.175....      84.175  No change from proposal.                        
84.176....      84.176  No change from proposal.                        
84.177....      84.177  No change from proposal.                        
84.178....      84.178  No change from proposal.                        
84.179....              Air velocity and noise levels for hoods and     
                         helmets is not included in final rule because  
                         these are applicable to powered air-purifying  
                         respirators only.                              
84.180....      84.179  1. Changed to limit requirements to non-powered 
                         air-purifying respirators.                     
                        2. Changed classification from ``solid'' and    
                         ``liquid and solid'' to ``N-series, R-series,  
                         and P-series.''                                
                        3. Changed efficiency level designations from A 
                         (99.97%), B(99%), and C (95%) to N100, R100,   
                         P100 (99.97%), N99, R99, P99(99%), N95, R95,   
                         and P95(95%).                                  
                        4. Changed labelling from S and L&S (e.g., Type 
                         A/L&S) to series and efficiency level (e.g.,   
                         P100 particulate filter (99.97% filter         
                         efficiency level)).                            
84.181....              Isoamyl acetate tightness test for particulate  
                         respirators with filters not intended to be    
                         replaced is not included in the final rule to  
                         avoid confusion and complications in the       
                         certification process.                         
84.182....              Isoamyl acetate tightness test for respirators  
                         with replaceable filters is not included in the
                         final rule to avoid confusion and complications
                         in the certification process.                  
84.183....      84.180  1. Changed to increase initial inhalation       
                         resistance from 30 mm water-column height to 35
                         mm.                                            
                        2. Changed to increase initial exhalation       
                         resistance from 20 mm water-column height to 25
                         mm.                                            
84.184....      84.181  1. Changed to limit requirements to non-powered 
                         air-purifying respirators.                     
                        2. Changed test terminology from filter         
                         penetration to filter efficiency.              
                        3. Changed to reduce the number of tested units 
                         from 30 to 20.                                 
                        4. Changed the test acceptance criterion from a 
                         statistical treatment of results to a pass/fail
                         criterion.                                     
                        5. Changed the tolerances for measurements to   
                         address testing consistency concerns.          
                        6. Changed aerosol loading of tested filters to 
                         add the P-series test until there is no further
                         decrease in efficiency.                        
                        7. Changed the description of dioctyl phthalate 
                         (DOP) aerosol to add a purity requirement.     
                        8. Changed to require only N-series filters     
                         (formerly solid only) to be preconditioned     
                         before testing. The proposal required          
                         precondition of all filters before testing.    
84.185....              Powered particulate respirator flow requirements
                         are not included in the final rule.            
84.186....      84.182  No change from proposal.                        
84.190....      84.190  No change from proposal.                        
84.191....      84.191  No change from proposal.                        
84.192....      84.192  No change from proposal.                        
84.193....      84.193  Changed from proposal to final rule for new     
                         incorporation by reference wording.            
84.194....      84.194  No change from proposal.                        
84.195....      84.195  No change from proposal.                        
84.196....      84.196  No change from proposal.                        
84.197....      84.197  No change from proposal.                        
84.198....      84.198  No change from proposal.                        
84.199....      84.199  No change from proposal.                        
[[Page 30398]]
                                                                        
84.200....      84.200  No change from proposal.                        
84.201....      84.201  No change from proposal.                        
84.202....      84.202  No change from proposal.                        
84.203....      84.203  No change from proposal.                        
84.204....      84.204  No change from proposal.                        
84.205....      84.205  No change from proposal.                        
84.206....      84.206  No change from proposal.                        
84.207....      84.207  No change from proposal.                        
84.250....      84.250  No change from proposal.                        
84.251....      84.251  No change from proposal.                        
84.252....      84.252  No change from proposal.                        
84.253....      84.253  No change from proposal.                        
84.254....      84.254  No change from proposal.                        
84.255....      84.255  No change from proposal.                        
84.256....      84.256  No change from proposal.                        
84.257....      84.257  No change from proposal.                        
84.258....      84.258  No change from proposal.                        
------------------------------------------------------------------------

  Subpart KK (Dust, Fume, and Mist; Pesticide; Paint Spray; 
Powered Air-Purifying High Efficiency Respirators and Combination 
Gas Masks) has been added to the final rule to allow needed 
applications for extensions of approvals for dust/fume/mist 
respirators previously approved under 30 CFR Part 11. This subpart 
also includes the requirements for powered air-purifying 
respirators.

84.1100  Scope and effective dates.
84.1101  Definitions.
84.1102  Examination, inspection and testing of complete respirator 
assemblies; fees.
84.1103  Approval labels and markings; approval of contents; use.
84.1130  Respirators; description.
84.1131  Respirators; required components.
84.1132  Breathing tubes; minimum requirements.
84.1133  Harnesses; installation and construction; minimum 
requirements.
84.1134  Respirator containers; minimum requirements.
84.1135  Half-mask facepieces, full facepieces, hoods, helmets, and 
mouthpieces; fit; minimum requirements.
84.1136  Facepieces, hoods, and helmets; eyepieces; minimum 
requirements.
84.1137  Inhalation and exhalation valves; minimum requirements.
84.1138  Head harnesses; minimum requirements.
84.1139  Air velocity and noise levels; hoods and helmets; minimum 
requirements.
84.1140  Dust, fume, and mist respirators; performance requirements; 
general.
84.1141  Isoamyl acetate tightness test; dust, fume, and mist 
respirators designed for respiratory protection against fumes of 
various metals having an air contamination level not less than 0.05 
milligram per cubic meter; minimum requirements.
84.1142  Isoamyl acetate tightness test; respirators designed for 
respiratory protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter, or 
against radionuclides; minimum requirements.
84.1143  Dust, fume, and mist air-purifying filter tests; 
performance requirements; general.
84.1144  Silica dust test for dust, fume, and mist respirators; 
single-use or reusable filters; minimum requirements.
84.1145  Silica dust test; non-powered single-use dust respirators; 
minimum requirements.
84.1146  Lead fume test for dust, fume, and mist respirators; 
minimum requirements.
84.1147  Silica mist test for dust, fume, and mist respirators; 
minimum requirements.
84.1148  Tests for respirators designed for respiratory protection 
against more than one type of dispersoid; minimum requirements.
84.1149  Airflow resistance tests; all dust, fume, and mist 
respirators; minimum requirements.
84.1150  Exhalation valve leakage test; minimum requirements.
84.1151  DOP filter test; respirators designed as respiratory 
protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter and 
against radionuclides; minimum requirements.
84.1152  Silica dust loading test; respirators designed as 
protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter and 
against radionuclides; minimum requirements.
84.1153  Dust, fume, mist, and smoke tests; canister bench tests; 
gas mask canisters containing filters; minimum requirements.
84.1154  Canister and cartridge requirements.
84.1155  Filters used with canisters and cartridges; location; 
placement.
84.1156  Pesticide respirators; performance requirements; general.
84.1157  Chemical cartridge respirators with particulate filters; 
performance requirements; general.
84.1158  Dust, fume, and mist tests; respirators with filters; 
minimum requirements; general.

[FR Doc. 95-13287 Filed 6-2-95; 12:10 pm]
BILLING CODE 4160-19-P