Respiratory Protective Devices; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUMMARY: This proposed rule addresses NIOSH's and the Department of

Labor/Mine Safety and Health Administration's (MSHA) certification

requirements for respiratory protective devices. Specifically, the

proposal would replace existing MSHA regulations with new public health

regulations, while also upgrading current testing requirements for

particulate filters.

This action is the first of a series of modules which will, over

the next several years, upgrade current respirator requirements. This

modular approach will allow improvements to be implemented on a

priority basis as well as facilitate adaptation to new requirements by

the manufacturers and users of respirators. Except for the particulate-

filter requirements, most requirements of existing regulations would be

incorporated into the new regulations without change. The proposed

testing requirements for particulate filters would significantly

improve the current approach to evaluating the effectiveness of an air-

purifying respirator's filter to remove toxic particulates from the

ambient air, updating existing provisions to be consistent with two

decades of advances in respiratory protection technology.

The certification of air-purifying respirators under these proposed

requirements would also enable respirator users to select from a

broader range of certified respirators that meet the current

performance criteria recommended by CDC for respiratory devices used in

health-care settings for protection against Mycobacterium tuberculosis,

the infectious agent that causes tuberculosis (TB).

This Notice also announces an informal public meeting on the

proposed rule, as indicated below.

Elsewhere in this issue of the Federal Register, MSHA is publishing

a proposal to remove existing regulations at 30 CFR part 11, which

would be made obsolete by a final rule resulting from this proposed

rule.

DATES: Written comments must be received at the NIOSH Docket Office

before the close of business on July 8, 1994. Interested persons

wishing to provide oral comments at an informal public meeting should

file a request for appearance with the NIOSH Docket Office no later

than the close of business May 31, 1994. The informal public meeting

will be held on June 7th and 8th, 1994, beginning both days at 9 a.m.

ADDRESSES: Comments on the proposed rule should be mailed in triplicate

to the NIOSH Docket Office, Robert A. Taft Laboratories, Mail Stop C34,

4676 Columbia Parkway, Cincinnati, Ohio 45226. Requests to participate

in the public meeting should be mailed in duplicate to the NIOSH Docket

Officer, at the same address. The informal public meeting will be held

at the Holiday Inn/Capitol, 550 C St., SW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, Chief,

Certification and Quality Assurance Branch, Division of Safety

Research, NIOSH, 944 Chestnut Ridge Road, Morgantown, West Virginia

26505-2888; the telephone number is (304) 284-5713. Additional copies

of this proposed rule can be obtained by calling the NIOSH toll-free

information number (1-800-35-NIOSH). Arrangements have also been made

for this proposed rule to be listed on the electronic bulletin boards

of the Government Printing Office and of the Department of Labor; the

telephone numbers are (202) 512-1387 and (202) 219-4784, respectively.

SUPPLEMENTARY INFORMATION:

I. Paperwork Reduction Act

Manufacturers seeking approval of respiratory protective devices

would continue to be required to submit applications for approval,

including related drawings, drawing lists, specifications, and

descriptions. The paperwork burden for this application process is

identical to that included in existing 30 CFR 11.10, previously

approved by the Office of Management and Budget (OMB).

However, those sections containing information collections are

being submitted to OMB for review under section 3504(h) of the

Paperwork Reduction Act of 1980. Other organizations and individuals

desiring to submit comments on the information collections should

direct them to the NIOSH Docket Office and to the Office of Information

and Regulatory Affairs; OMB, New Exectutive Office Building (Room

3208), Washington, DC 20503, ATTN: Desk Officer for HHS/PHS/CDC/NIOSH.

II. Background

The existing rules and procedures in 30 CFR Part 11 for approval of

respiratory-protective devices, or respirators, evolved from rules and

procedures developed by the U.S. Department of the Interior, Bureau of

Mines (BOM). Until 1972, the BOM was solely responsible for testing and

approving respirators. In 1972, Part 11 was published jointly by the

BOM and NIOSH. This regulation replaced the BOM's rules and procedures,

and delineated the responsibilities of the two agencies. Under this

regulation, the BOM evaluated respirator performance, and NIOSH was

responsible for administration of the quality control provisions. The

BOM also tested the safety of electrical components of respirators for

use in potentially explosive atmospheres in underground-gassy mines

(intrinsic safety) under the requirements of 30 CFR part 18.

A Memorandum of Understanding, dated May 30, 1972, between the two

agencies refined their respective roles, and part 11 was amended in

1973. Under this arrangement, NIOSH undertook primary responsibility

for performance testing of respirators. Although all approvals

continued to be issued jointly, the BOM primarily retained only the

responsibility to test for intrinsic safety on the small number of

respirators that had electrical components.

The Mining Enforcement and Safety Administration, MSHA's

predecessor agency, was created in 1974, and the responsibilities of

the BOM under part 11 were transferred to that agency. Since MSHA was

created in 1978, it has continued to test electrical components of

respirators for intrinsic safety. MSHA has issued separate approvals

for respirators meeting the requirements of 30 CFR part 18. While MSHA

currently reviews applications for respirator certifications and has

conducted some product evaluations, laboratory testing, quality

assurance, and product audit for certain respirators, the principal

testing and approval activities specified by part 11 are primarily

conducted by NIOSH. NIOSH is proposing to redesignate the requirements

for the certification of respiratory-protective devices of part 11 to

part 84 of Title 42 (42 CFR part 84) under this action.

Following promulgation of 30 CFR part 11 in 1972, NIOSH began

conducting research in several areas of respiratory protection.

Concurrently, NIOSH began to receive public input concerning the

respirator-certification program.

In December 1977, NIOSH conducted a public meeting to obtain

comments on changes needed in 30 CFR part 11. In 1979, a group of

outside consultants conducted a thorough review of the program. The

report received from those consultants was published by NIOSH for

further consideration by other interested persons, and a public meeting

was held in July 1980 to obtain their comments on the program. In

December 1981, the American National Standards Institute Z88 Committee

on Respiratory Protection commented on 30 CFR part 11. In January 1982,

the Mine Health Research Advisory Committee transmitted its

recommendations to NIOSH for further changes to the program. Since

1982, NIOSH has solicited and investigated reports of problems with

NIOSH/MSHA-certified respirators with the purpose of obtaining direct

public input into the approval program.

Investigations, research, comments, and analyses were considered by

NIOSH and MSHA in preparation of a proposed comprehensive revision to

the approval requirements. These changes to existing requirements and

tests were proposed as a new 42 CFR part 84, which was published on

August 27, 1987 (52 FR 32402). Two public meetings were held to obtain

comments on the proposal (in San Francisco, CA on January 20, 1988, and

in Washington, D.C. on January 27-28, 1988). Two extensions of the

public comment period were issued (52 FR 37639 and 53 FR 5595), with it

ending on March 28, 1988. Concurrent with the publication of the

proposed part 84, MSHA published a notice in the Federal Register (52

FR 32313) proposing the withdrawal of 30 CFR part 11 upon final

publication of 42 CFR part 84. Under that proposal, MSHA would have

retained a consultative role in the approval of respirators used in

mining in order to protect the health and safety of miners,

particularly concerning mine rescue and mine emergency respirators.

During the 7-month comment period following the publication of the

proposed part 84, NIOSH received 271 comments on this comprehensive

proposal. Since receiving these comments, NIOSH has been conducting

investigations and research to consider the technical issues addressed

in these comments. Delays have been experienced in finalizing a revised

part 84 draft as a result of the number and diversity of the comments

received. NIOSH determined that at least four major, and more than one

hundred minor technical and administrative changes to the first

comprehensive proposal would be required to adequately address all the

areas of concern. Consequently, NIOSH has reevaluated its intent to

develop and implement a single, comprehensive revision to the existing

regulation of part 11.

Instead, NIOSH intends to promulgate modifications to the existing

requirements of 30 CFR part 11 in a series of modules. There are

numerous benefits to utilizing a modular approach to promulgate the

anticipated changes to the existing requirements. Among these are the

following considerations:

1. Improvements can be implemented on a priority basis, assuring

that those expected to contribute most to improving worker protection

are implemented first,

2. Incremental promulgation of improvements should facilitate

adaptation to new requirements by the respirator manufacturer and user

communities, minimizing the potential for any disruption in the supply

of certified respirators, and

3. Public participation in the rulemaking process will be

facilitated by proposing important regulatory changes in individual

segments of separate rulemaking.

The anticipated subjects and sequence of the NIOSH rulemaking,

according to this modular approach are:

------------------------------------------------------------------------

Anticipated

Subject area timetable for

proposed rule

------------------------------------------------------------------------

Particulate Filter Tests.............................. May 1994.

Assigned Protection Factors........................... Late 1994.

Administrative Program (application submittal and Early 1995.

processing, fee structure, etc.).

Quality Assurance Requirements........................ Early 1995.

Gas and Vapor Requirements............................ Mid 1995.

Positive Pressure SCBA Requirements................... Early 1996.

Simulated Workplace Protection Factor Test............ Early 1997.

------------------------------------------------------------------------

NIOSH is proposing a limited revision to the existing requirements

of 30 CFR part 11 in this first ``module'', requiring updated

particulate filter tests. These proposed changes would produce

significant improvements in the level of protection provided to the

wearers of the respiratory protective devices and would enable users to

easily discern the level of protection that can be expected when using

a particular respirator, with little impact on the certification

process. NIOSH estimates that these changes to the particulate filter

requirements will affect approximately 80% of all respirators currently

marketed.

These new filter requirements would update the existing 30 CFR part

11 provisions to provide a particulate efficiency determination and

classification system consistent with advances in respiratory

protection technology. The tests to determine the respirator filter's

particulate efficiency enable classification of the filters on their

ability to inhibit the penetration of particulates of the most

penetrating size. The effectiveness of a device to remove particulates

from the ambient air would be reflected in a three-tiered

classification system based on the filter's demonstrated efficiency.

Classification of the filters in this manner eliminates the need to

test and classify the filter respirator according to composition of

contaminant (e.g., ``dust, fume, and mist'', ``asbestos''), since the

penetration rate for particulates in the atmosphere, regardless of

composition, will not exceed that of the test particulate. To revise

respirator nomenclature to be consistent with this fundamental change

in certification philosophy, the words ``dust, fume and mist'' have

been changed to ``particulate'' in the proposed rule.

NIOSH has long been concerned with the health risks to workers due

to the inappropriate selection and use of dust/mist and dust/fume/mist

respirators. Assigned Protection Factor (APF) values are used in the

respirator selection process to indicate the expected protection level.

NIOSH has considered the possibility of reducing the Assigned

Protection Factor (APF) values given in the NIOSH Guide to Industrial

Respiratory Protection and in the Respirator Decision Logic for dust

and fume respirators to account for filter penetration that can occur,

theoretically, when these respirators are inappropriately used against

aerosols less than 2 micrometers in diameter. On September 15, 1992,

NIOSH prepared a draft report, ``A Performance Evaluation of DM and DFM

Filter Respirators Certified for Protection Against Toxic Dusts, Fumes,

and Mist,'' explaining its concerns and suggested course of action.

NIOSH solicited an external scientific peer review of this draft report

on September 15, 1992. This review did not support an immediate

revision of the APF values. The reviewers recommended that NIOSH

address the concern about excessive filter penetration by incorporating

improved filter-penetration tests into the respirator certification

regulation.

After careful consideration of this issue, NIOSH agrees with the

scientific reviewers that, during the transition period for the

implementation of the provisions contained in this rule, an adjustment

of APF values is unnecessary and may confuse respirator users. NIOSH

will continue to recommend the APF values contained in the NIOSH Guide

to Industrial Respiratory Protection (September 1987) and in the

Respirator Decision Logic (May 1987) for respirators previously

certified under the provisions of 30 CFR part 11. For respirators

certified for protection against particulate exposures under the new

part 84 which would replace the existing Dust/Mist and Dust/Fume/Mist

filter respirators under 30 CFR part 11, NIOSH will be recommending new

APF values that account for the new nomenclature and test criteria.

These new values, updating the recommendations cited above, will be

published in a Respirator User's Notice accompanying publication of

this rule as final. It is anticipated that the module on Assigned

Protection Factors will be proposed in late 1994, at which time public

comment will be solicited.

The current regulation in 30 CFR part 11 was developed to certify

respirators used in mining and general industry. They do not contain

performance requirements for certifying air-purifying respirators

against biological agents. Likewise, the modifications to the current

requirements in this proposed rule were not developed specifically to

certify respirators against biological agents. However, the provisions

of this rule will address an important public health need regarding the

control of Mycobacterium tuberculosis, the causative agent of TB,

transmission in health care and other facilities.

In response to the recognized risk of TB transmission in health-

care facilities, increases in TB in many areas, and recent outbreaks of

multidrug-resistant TB, CDC has published draft recommendations

revising existing CDC guidelines for preventing the transmission of

tuberculosis in health care facilities, entitled ``Guidelines for

Preventing the Transmission of Tuberculosis in Health-Care Facilities,

Second Edition'', published in the Federal Register on October 12, 1993

(58 FR 52810). This draft enumerates four performance criteria that CDC

has determined are necessary for respiratory protective devices used in

health-care settings for protection against TB. The only currently

certified air-purifying respirator class that meets all the respiratory

protection performance criteria in the CDC draft is a respirator with a

high efficiency (HEPA) filter. However, all six classes of air-

purifying, particulate respirators to be certified under the provisions

of the new particulate filter tests (filter penetration) would meet or

exceed the performance recommendations contained in the CDC document.

These other classes of air-purifying, particulate respirators are

expected to be markedly less expensive than respirators with HEPA

filters.

Consequently, immediate implementation of the modifications

included in this rule should promote a substantial increase in

respiratory protection provided to health care and other workers

potentially exposed to the M. tuberculosis droplet nuclei in health-

care and other occupational settings. For this reason, NIOSH is moving

forward with a schedule to publish a final rule pertaining to

particulate filters in late-1994.

III. Public Meeting

The record of the informal public meeting will remain open until

July 8, 1994 to allow interested persons to submit written statements

or comments regarding oral presentations made at the public meeting.

The rule is proposed to be effective as follows:

1. 42 CFR part 84 will be effective 30 days from publication of

this rule as final, and;

2. Sale and distribution of respirators listed as certified under

the provisions of 30 CFR Part 11, subparts K or M will no longer be

authorized effective 2 years from the date of publication of this rule

as final.

NIOSH is specifying an effective date for implementation for the

final rule to allow the introduction of filters demonstrating enhanced

performance as soon as possible. The existing 30 CFR part 11 is

expected to remain in effect for 6 months after this rule becomes final

to provide a transition period for manufacturers to prepare for new 42

CFR part 84 applications. NIOSH believes that this period provides

ample transition time for manufacturers to assemble the information

necessary for application for certification of particulate respirators

under the new part 84. Additionally, 2 years from the date this rule

becomes final, respirators can no longer be distributed or sold as

NIOSH-approved under part 11, subpart K or M, unless they demonstrate

compliance with and are certified under the provisions of the new part

84. This 2-year period was selected to ensure that an ample supply of

respirators remain available for use. NIOSH believes that this

timeframe will provide ample time for manufacturers to have respirators

approved and manufactured in sufficient quantities to meet the demand.

NIOSH specifically requests comments on the appropriateness of a 2-year

phase-in period, as proposed.

The administrative record of this rulemaking will consist of this

May 24, 1994 Notice of Proposed Rulemaking; all other relevant Federal

Register notices; agency records on this subject; all written

submissions made in response to the Notices; and the record of the

informal public meeting. The record of the informal public meeting will

consist of the meeting schedule, transcripts made by NIOSH of the oral

comments at the meeting, any written comments submitted by presenters

at the meeting, and statements or comments regarding oral presentations

made at the public meeting submitted by interested persons within the

allotted comment period. No written submission, or any portion thereof,

made in response to this Notice will be received or held in confidence.

The administrative record of the rulemaking will be made available for

viewing and copying in the NIOSH Docket Office. All requests for any

portion of the administrative record must be submitted in writing.

All interested persons are encouraged to submit written comments to

assure receipt on or before the close of business July 8, 1994, and to

advise the NIOSH Docket Office by the necessary date of their intent to

participate in the informal public meeting. All requests for appearance

at the informal public meeting should contain the name, address, and

telephone number, any business affiliation of the person desiring to

make a presentation, a brief summary of the presentation, and the

approximate time requested for the presentation. NIOSH requests that

oral presentations be limited to 10 minutes. Groups having similar

interests are requested to combine their comments and present them

through a single representative. NIOSH will assign the time available

for the meeting among the persons who properly file a request for

appearance.

After reviewing the submitted summaries and the requests for

appearance, NIOSH will schedule each appearance and notify each

participant by mail or telephone of the time assigned to the person and

the approximate time the person's oral presentation is scheduled to

begin. The meeting schedule will be placed on file in the NIOSH Docket

Office.

The proceedings of the meeting will be transcribed. Any interested

person may, consistent with the orderly conduct of the meeting, record

or otherwise make a transcript of the meeting. Each participant may

present relevant written information, data, or views for inclusion in

the record of the meeting.

Any person who desires to submit an advance written statement may

file three copies with the NIOSH Docket Office. A participant may be

accompanied by a reasonable number of additional persons, space

permitting.

If a participant is not present when his or her presentation is

scheduled to begin, the remaining participants will be heard in order.

At the conclusion of the meeting, an attempt will be made to hear any

scheduled participants who missed his or her assigned time. Interested

persons attending the meeting who did not request an opportunity to

make an oral presentation may be given an opportunity to do so at the

conclusion of the meeting, at the discretion of the presiding officer.

IV. Discussion of Proposed Rule--Testing of Particulate Filters

The BOM was solely responsible for testing and approving

respirators until 1972. In 1972, the existing rules and procedures in

30 CFR part 11 for approval of respiratory protective devices, or

respirators, were published jointly by the BOM and NIOSH. Since 1974,

the Mining Enforcement and Safety Administration (MSHA's predecessor

agency), MSHA, and the Occupational Safety and Health Administration

(OSHA) have regulated the selection, use, and maintenance of

respirators in the workplace under their enforcement authorities. With

this redesignation of the requirements for the certification of

respirators, NIOSH is deleting Secs. 11.2 and 11.21 because these

sections of part 11 have been superseded by OSHA's and MSHA's

respirator workplace regulations. Also, the codification of the

redesignated sections into a non-hyphenated numbering system results in

the deletion of several ``general heading'' sections that contain no

substantive requirements. These include Secs. 11.85, 11.102, 11.124,

11.140, and 11.162.

Existing subpart M of part 11 (Secs. 11.170 through 11.183-7)

addresses the requirements for pesticide respirators. The proposal

eliminates this category and the tests specific to it, leaving subpart

M reserved. The proposal also eliminates all references to subpart M

and pesticides as a classification for approval. Manufacturers can

continue to manufacture and market respirators labelled for use as

pesticide respirators, as well as other contaminant classifications,

based on the testing performed under the proposed filter penetration

test. NIOSH, however, would discontinue issuance of certifications that

classify these respirators as suitable for use against a specific

particulate. The proposed test would provide a suitable determination

as to the effectiveness of the filter element in removing particulates

from the ambient air, regardless of the contaminant.

The existing test requirements in Secs. 11.124-21 through 11.124-24

specify a person wearing the respirator to be exposed to an abrasive

blasting environment in which the blasting agent is composed of 99+

percent free silica (SiO2). The purpose of this requirement was to

determine the adequacy of protection provided in such environments.

Over the past two decades, NIOSH has not conducted these tests which

would pose known or potential health risks of exposure to fractured

crystalline silica to prospective test subjects. These tests have been

replaced administratively. This policy will remain in effect until

these regulatory requirements are addressed in a later module.

The proposed 42 CFR part 84 regulation is generally consistent with

the current MSHA and NIOSH respirator approval program, placing

responsibility for certifying most respirators with NIOSH. MSHA and

NIOSH would continue to jointly review and approve respirators used for

mine emergencies, mine rescue, and the associated service-life plans,

users' manuals, and other documentation. Among the types of devices for

which this role is particularly important are self-contained self-

rescue devices. This preserves MSHA's current role in the certification

of certain respirators whose unique use in mining is an important part

of safeguarding the health and safety of miners. In addition, MSHA

would continue to test electrical and electronic components of

respirators for use in potentially explosive atmospheres in underground

gassy mines and issue a separate MSHA approval under 30 CFR part 18 for

such respirators. In implementing the proposed regulation, NIOSH and

MSHA will develop a new Memorandum of Understanding which will reflect

administrative matters related to respirator approval, including

immediate notification to MSHA of field complaints and identified

deficiencies concerning approved respirators.

With the transfer of part 11 from title 30 to part 84 of title 42,

MSHA and NIOSH would no longer process applications for new approvals

or extensions of approval of respirators under part 11 provisions. All

applications received after the effective date of part 84 will be

considered as applications for a new or extension of approval under

part 84. NIOSH realizes that with this step in the development of part

84, some of the respirators that are currently approved would need to

be modified to meet the new requirements, while some would not.

Additionally, with each step in the modular rulemaking approach being

pursued, an increasing number of respirator designs will be affected by

the new regulation. NIOSH realizes that the incremental implementation

of improved test and performance requirements could cause some

confusion as to which respirators have demonstrated performance to the

improved requirements. To address this possibility, the Institute

intends to continue issuing new and extension of approval numbers in

the same format designation (TC number) as issued under existing part

11 for those respirator types whose technical requirements for approval

under part 84 have not been modified from existing part 11. A new

approval number series will be initiated for the products whose

technical requirements have been upgraded under part 84. By checking

the approval number, respirator users will be able to quickly and

easily distinguish those products that have demonstrated the improved

performance requirements of the new part 84 from those that have

demonstrated compliance with only the existing part 11 standard. The

Institute further intends to issue public notices of the new approval

designations to be used for the products demonstrating improved

performance to alert users that such improved standards are available.

Section-by-Section Discussion

All sections redesignated to 42 CFR part 84 without modification

from 30 CFR part 11 are not included in this discussion of the proposed

rule. The sections redesignated without modification will be revised,

where appropriate, to:

(1) remove references to MSHA, except for those related to certain

mining applications,

(2) update the NIOSH certifying organization to the Certification

and Quality Assurance Branch, Division of Safety Research, NIOSH, 944

Chestnut Ridge Road, Morgantown, West Virginia 26505-2888,

(3) remove references to subpart M, pesticide respirators, and

tests for protection during abrasive blasting, and

(4) correct nonsubstantive typographical errors and reference the

new part 84 section designations.

The sections redesignated without modification are as follows:

84.1, 84.3, 84.11, 84.12, 84.21, 84.22, 84.30, 84.31, 84.32, 84.34,

84.35, 84.36, 84.40, 84.41, 84.42, 84.43, 84.50, 84.51, 84.53, 84.60,

84.62, 84.63, 84.64, 84.65, 84.66, 84.70, 84.71, 84.72, 84.73, 84.74,

84.75, 84.76, 84.77, 84.78, 84.79, 84.80, 84.81, 84.82, 84.83, 84.84,

84.85, 84.86, 84.87, 84.88, 84.89, 84.90, 84.91, 84.92, 84.93, 84.94,

84.95, 84.96, 84.97, 84.98, 84.99, 84.100, 84.101, 84.102, 84.103,

84.104, 84.110, 84.111, 84.112, 84.113, 84.114, 84.115, 84.116, 84.117,

84.118, 84.119, 84.120, 84.121, 84.122, 84.123, 84.124, 84.126, 84.130,

84.131, 84.132, 84.133, 84.134, 84.135, 84.136, 84.137, 84.138, 84.139,

84.140, 84.141, 84.142, 84.143, 84.144, 84.145, 84.146, 84.147, 84.148,

84.149, 84.150, 84.151, 84.152, 84.153, 84.154, 84.155, 84.156, 84.157,

84.158, 84.159, 84.160, 84.161, 84.162, 84.163, 84.172, 84.173, 84.174,

84.175, 84.176, 84.178, 84.179, 84.186, 84.190, 84.191, 84.192, 84.193,

84.194, 84.195, 84.196, 84.197, 84.198, 84.199, 84.200, 84.201, 84.202,

84.204, 84.205, 84.207, 84.250, 84.251, 84.252, 84.253, 84.254, 84.255,

84.256, 84.257, and 84.258.

These sections, and revisions of these sections, will be subject to

public comment in future rulemaking.

The following section-by-section analysis discusses each new or

revised section to 42 CFR part 84. All part and section references for

part 11 are to Title 30 of the Code of Federal Regulations (30 CFR).

All part and section references for part 84 are to Title 42 of the Code

of Federal Regulations (42 CFR).

Subpart A--General Provisions

Section 84.2 Definitions

This section would be redesignated and revised from the existing

Sec. 11.3.

The existing definitions for ``air contamination level'',

``Bureau'', ``concentration limits for radionuclides'', ``DOP'',

``MESA'', ``pesticide'', ``radionuclides'', and ``smoke'' would be

deleted. These terms are used in provisions that are modified or

deleted as a result of the filter penetration test changes being

proposed. These definitions would, therefore, become unnecessary.

The existing definition for ``Testing and Certification

Laboratory'' would be modified to reflect the present name of the

organization as the ``Certification and Quality Assurance Branch.''

Section 84.4 Respirators For Mine Rescue or Other Emergency Use In

Mines

This section would be new, and would maintain MSHA's role in the

approval of respirators designed for mine rescue or other mine

emergency use. Under the proposal MSHA and NIOSH would conduct joint

review and certification of respirators used for mine emergencies and

mine rescue. This provision recognizes MSHA's expertise in identifying

the special needs and considerations for respirators used in the mining

environment. This role would replace MSHA's existing role as a joint

approver of all respirators.

Paragraph (a) specifies that NIOSH and MSHA would jointly certify

any respirator designed for mine emergencies, mine rescue or other

emergency use in mines. This joint review and certification would

include any associated service-life plans, user's manuals, and other

supporting documentation. This paragraph further specifies that

certifications for these respirators include any identified use

limitations related to mine safety and health as a condition of

certification.

Paragraph (b) specifies NIOSH and MSHA would jointly address recall

and retrofit matters arising from field complaints or identified

deficiencies concerning any respirators used in the mining environment.

The new Memorandum of Understanding would further delineate MSHA's role

in such matters, including participation in any related field or

manufacturing site audits.

Subpart B--Application for Approval

Section 84.10 Application Procedures

This section would be redesignated from existing Sec. 11.10 with

only paragraph (e) modified. Paragraph (e) would retain the existing

requirement for inspection, examination, and testing by MSHA of

electrical and electronic components to be permissible in accordance

with 30 CFR part 18 for respirators intended for use in mining

environments and having permissible electrical or electronic

components. MSHA would continue to conduct this testing and issue a

separate MSHA approval number for those respirators found acceptable.

The process for conducting the permissibility evaluation of these

components and their identification would remain unchanged from the

existing policies and practices.

Subpart C--Fees

Section 84.20 Examination, Inspection, and Testing of Complete

Respirator Assemblies; Fees

This section would be redesignated from existing Sec. 11.20, and

modified only to reflect the new particulate filter classification

scheme.

Subpart D--Approval and Disapproval

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

This section would be redesignated from existing Sec. 11.33.

Paragraph (b) would specify the use of the NIOSH emblem on the

approval label, replacing the MSHA emblem.

Paragraph (e) of this section would be modified to identify the

existing ``dust, fume, and mist'' class of respirator as a

``particulate'' respirator. The new designation is consistent with the

proposed testing criteria under which these respirators are certified.

The table in paragraph (e) identifying the approval label requirements

would be modified by the removal of references specific to paint spray

and pesticide respirators, also consistent with the changes associated

with the instantaneous penetration tests.

Subpart F--Classification of Approved Respirators; Scope of

Approval; Atmospheric Hazards; Service Time

Section 84.52 Respiratory Hazards; Classification

This section would be redesignated from existing Sec. 11.52.

It would be modified only to delete paragraph (d). Reference to the

pesticide ``classification'' would no longer be appropriate with the

introduction of the ``particulates'' classification with the new

instantaneous-penetration test.

Subpart G--General Construction and Performance Requirements

Section 84.61 General Construction Requirements

This section would be redesignated from existing Sec. 11.61.

The provision for respirator components to meet the permissibility

requirements of 30 CFR part 18 [paragraph (e)] would be deleted because

MSHA's workplace regulations separately and independently establish

this requirement for certain mining applications. This change would be

consistent with existing practice, whereby, MSHA conducts the

evaluation and testing of these components and issues a separate

approval to cover this aspect of respirator design.

Subpart I--Gas Masks

Section 84.125 Particulate Tests; Canisters Containing Particulate

Filters; Minimum Requirements

This section would be redesignated from existing Sec. 11.102-4,

without modification except to specify the new requirements that

respirators for protection against particulates (dusts, fumes, mists,

and smokes) in combination with gases, vapors, or gases and vapors,

must meet. With the exception of the airflow resistance test of

Sec. 84.183, these respirators are required to meet the proposed

requirements specified in Secs. 84.170 through 84.186.

Subpart K--Particulate Respirators

Section 84.170 Particulate Respirators; Description

This section would be derived from existing Sec. 11.130. It would

be revised to define particulate respirators in a more concise way than

previously provided for those designed for protection against dusts,

fumes, and mists.

Paragraph (a) would describe particulate air-purifying respirators

as those designed with filters to provide respiratory protection

against atmospheres that: (1) Contain adequate oxygen to support life

and (2) are contaminated with particulates not immediately dangerous to

life or health. The particulates for which protection would be provided

include contaminants such as dusts, fumes, mists and smoke. The

respirator could be designed to remove contaminants, either solid or

both liquid and solid, from the wearer's breathing air.

Paragraph (b) would establish the classification of particulate

air-purifying respirators as either powered or non-powered. Powered

respirators would include those designs where a motor or other device

enhances the air flow of inhalation air through the filter to provide

breathing air to the wearer. Non-powered respirators would include

respirators that depend solely on the inhalation and exhalation of the

wearer to provide an adequate supply of purified-breathing air to the

wearer. Either class of respirator, powered or non-powered, could be

designed and intended for removal of solid particulates only or for

both liquid and solid particulates. A ``liquid only'' category is not

included because a filter that can effectively remove liquid

particulates from the ambient air will also effectively remove solid

particulates.

Paragraphs (c) and (d) would establish the classification of filter

elements used with non-powered and powered air-purifying respirators,

respectively. These classifications are based on the filter's

efficiency in removing particulates from the ambient air as

demonstrated by the test requirements specified in this subpart.

Paragraphs (c)(1) and (d)(1), (c)(2) and (d)(2), and (c)(3) would

define the efficiency level for particulate removal needed to be

achieved in the performance testing for a filter element to be

classified as a Type A, B, or C filter, respectively. A Type A filter

would be required to perform at a minimum efficiency of 99.97%, a Type

B filter at a minimum efficiency of 99%, and a Type C at a minimum

efficiency of 95%.

Section 84.171 Particulate Respirators; Required Components

This section would be redesignated from existing Sec. 11.131,

modified only to incorporate the new terminology of ``particulates'' to

describe dusts, fumes and mists.

Section 84.177 Inhalation and Exhalation Valves; Minimum Requirements

This section would be redesignated from existing Sec. 11.137,

modified only to delete reference to the existing silica dust tests for

single-use respirators of Sec. 11.140-5. The respirator performance

requirements of these existing tests are replaced by the particulate

instantaneous filter penetration test contained in this proposal.

Section 84.180 Particulate Respirators; Filter Type Identification

This section proposes a new classification system for

identification of the efficiency of the filters for particulate

respirators. The new proposed terminology of ``particulate respirator''

would replace the existing ``dust, fume, and mist respirator'', as

discussed previously.

The requirement for the manufacturer to specify the filter-

efficiency/particulate-type classification in the certification

application would be contained in paragraph (a). This classification

would include the type of particulates that the filter is designed to

remove, either solid or both liquid and solid, and the expected

efficiency of the filter based on the test requirements specified in

Sec. 84.184.

The information to be included on the label of a filter for a

certified particulate respirator is specified in paragraphs (b)(1)

through (b)(6). This labeling would define the efficiency level

achieved in the performance testing (i.e., Type A, B, or C filter) and

whether the filter would perform properly in the removal of solid only

(S) or both liquid and solid (L&S) particulates. This information would

be necessary to allow the user to make an informed decision on

selecting the appropriate respiratory protection. To facilitate this

selection process, the Type A, L&S filters are color coded magenta to

allow them to be easily distinguished from the other filter types. The

filters other than Type A, L&S could be of any color, except magenta.

This color coding would be consistent with the present universally-

accepted color-code convention which identifies the best performing

filters (HEPA's) by their magenta color.

Section 84.181 Isoamyl Acetate Tightness Test; Particulate Respirators

With Filters Not Intended To Be Replaced

This section would be redesignated from existing Sec. 11.140-1 with

the test unchanged. Because the proposal would not classify respirators

as designed for protection against fumes from various metals having an

air contamination level not less than 0.05 milligram per cubic meter,

the test would be redirected to evaluate the performance of particulate

respirators with filters not intended to be replaced.

Section 84.182 Isoamyl Acetate Tightness Test; Respirators With

Replaceable Filters; Minimum Requirements

This section would be redesignated from existing Sec. 11.140-2 with

the test unchanged. Because the proposal would not classify respirators

designed for protection against dusts, fumes and mists having an air

contamination level less than 0.05 milligram per cubic meter, or

radionuclides, the test would be redirected to evaluate the performance

of particulate respirators with replaceable filters.

Section 84.183 Airflow-Resistance Tests

Section 84.183 would be redesignated from Sec. 11.140-9, modified

to delete the final inhalation resistance requirements. The proposed

instantaneous-penetration tests are not designed to simulate loading of

the filter at the worksite, and represent a significant change in the

testing philosophy from the existing requirements. Therefore, these

requirements would not be necessary or appropriate with the

introduction of these new tests.

Section 84.184 Particulate Instantaneous-Penetration-Filter Test

This section would be new. Section 84.184 would specify the test

criteria and acceptable performance criteria for the new particulate

instantaneous-penetration-filter test.

Paragraph (a) would require the instantaneous-penetration

efficiency testing of 30 filters of each particulate respirator model.

Testing would be conducted using a solid particulate aerosol or an oil

liquid particulate aerosol for solid particulate certification and both

liquid and solid particulate certification, respectively.

Paragraph (b) would apply to filters having separable air-purifying

elements. All the respirator's air-purifying elements, including the

element's holders and gaskets, are specified to be installed on the

respirator as used when mounted for testing.

Paragraph (c) would require the preconditioning of all air-

purifying elements of the respirators prior to testing. The elements,

removed from their packaging, are placed in an environment of

855 percent relative humidity at 382.5 degrees

celsius (1004.5 degrees fahrenheit) for 251

hours. Following the humidity conditioning, filters are required to be

sealed in a gas-tight container until tested.

Paragraph (d) would apply to filters having non-separable air-

purifying elements. It would require the exhalation valves to be sealed

during the testing. Sealing of the valves would ensure that the test

results were not affected by any valve leakage, if present.

Paragraph (e) would specify the continuous test-aerosol airflow

rates to be used in testing single and paired filters. Respirators with

a single filter are penetration-tested at a continuous airflow rate of

85 liters (3.0 cubic feet) per minute 5 percent. For pairs,

the test-aerosol airflow rate would be 42.5 liters (1.5 cubic feet) per

minute 5 percent through each filter. This airflow rate is

representative of a high work rate. These test conditions would ensure

that a sufficient number of particulates are applied to the filter

during the test period to provide an adequate indication of the

efficiency of the filters.

Paragraph (f) would specify the test criteria for powered air-

purifying particulate respirators (PAPRs). The PAPRs are penetration

tested while operating in their routine operational mode. This would

require fully-charged batteries, if so equipped, or at normal line

voltage, if line-powered. PAPRs with loose fitting facepieces are

tested in a free-flow mode, while those with tight-fitting facepieces

are tested on a headform connected to a breathing machine or equivalent

breathing device. The breathing machine would have a workrate cam of

622 kp-m/min. operated at a rate of 24 respirations per minute with a

minute volume of 40 liters.

Paragraph (g) would describe the penetration test aerosols and the

test criteria to be used. A sodium chloride solid aerosol would be used

when testing for filter leakage of solid particulate aerosols. A

neutralized-dioctyl phthalate (DOP), or equivalent oil, liquid aerosol

would be specified as the testing agent when testing for filter leakage

of liquid particulate aerosols. The penetration test would be continued

until maximum penetration is achieved or until an aerosol mass of at

least 2005 mg for non-powered respirators, or at least

2,00050 mg for powered air-purifying respirators, has

contacted the filter unit.

Paragraph (g)(1) would identify the test conditions for the sodium

chloride solid aerosol to be at 255 degrees celsius

(779 degrees fahrenheit) and relative humidity of less than

30 percent. The aerosol specified to be used in these tests would be

neutralized to the Boltzmann equilibrium state, and the maximum

concentration would not exceed 200 mg/m\3\.

Paragraph (g)(2) would specify the DOP or equivalent oil, liquid

particulate aerosol. The test conditions for the liquid aerosol are

specified to be at 255 degrees celsius. The aerosol

specified to be used in these tests would be neutralized to the

Boltzmann equilibrium state, and the maximum concentration would not

exceed 200 mg/m\3\.

Paragraph (h) would specify the particle size limitations at the

test conditions for the filter-penetration-test aerosols. The sodium

chloride aerosol would have a particle size distribution with count

median diameter between 0.06 and 0.11 micrometer and a standard

geometric deviation not exceeding 1.84. The liquid particulate aerosol

would have a particle size distribution with count median diameter

between 0.17 and 0.22 micrometer and a standard geometric deviation not

exceeding 1.60. These particle size distribution values would be

determined at the specified test conditions with a differential

mobility particle sizer.

Paragraph (i) would require the instantaneous penetration of the

filter (i.e., the amount of aerosol particles that pass through the

filter) to be monitored and recorded throughout the test period by a

suitable forward-light-scattering photometer or equivalent

instrumentation.

Paragraph (j) would require the maximum filter penetration for each

of the 30 filters to be determined and recorded. The mean maximum

penetration, m, and the standard deviation, s, would be required to be

calculated from these data. The test static U for the particulate

respirator filter would be calculated as the sum of the mean maximum

penetration and 2.22 multiplied by the standard deviation. The test

static would be used to determine if the performance of the filter

would meet the requirement for the requested classification (type). For

a type A filter, the test static would be less than or equal to 0.0003;

for a type B, the test static would be less than or equal to 0.01; for

a type C, the test static would be less than or equal to 0.05.

Section 84.185 Powered, Particulate Respirator Flow Requirements

This section would be new. It would specify the minimum

requirements and criteria for verification of the airflow rates of

powered, particulate respirators. This section would also define the

classes as loose-fitting and tight-fitting, depending on their reliance

on the tightness of the face seal.

The airflow of a powered air-purifying respirator would be measured

after each of the penetration tests. The airflow requirements that a

powered air-purifying respirator would be required to meet are

specified based on its design classification as tight-fitting or loose-

fitting. The minimum airflow requirements for each class are specified

in paragraphs (a) and (b) of this section. A tight-fitting, powered,

air-purifying respirator would be defined as designed to seal to the

wearer's face and provide protection as a non-powered respirator in the

event of a blower failure. A loose-fitting, powered, air-purifying

respirator would be defined as designed to function without reliance on

a tight-fitting face seal.

Paragraph (a) would require tight-fitting, powered air-purifying

respirators to maintain an air-flow rate of at least 115 liters (4.06

cubic feet) per minute for a period of at least 4 hours unless

otherwise specified.

Paragraph (b) would require loose-fitting, powered air-purifying

respirators to maintain an air-flow rate of at least 170 liters (6.0

cubic feet) per minute for a period of at least 4 hours, unless

otherwise specified.

Paragraph (c) would require powered air-purifying respirators to be

provided with an acceptable mechanism and appropriate instructions,

whereby, the user can routinely and simply determine that the minimum

airflow is maintained.

Subpart L--Chemical Cartridge Respirators

Section 84.203 Breathing Resistance Tests; Minimum Requirements

This section would be redesignated from existing Sec. 11.162-1.

It would be modified only to delete reference to various

``classifications'', such as paints and pneumoconiosis and fibrous

producing dusts, that would no longer be appropriate with the

introduction of the ``particulates'' classification with the new

instantaneous-penetration test.

Section 84.206 Particulate Tests; Respirators With Filters; Minimum

Requirements; General

This section would be redesignated from existing Sec. 11.162-7. It

would be modified only to delete reference to various

``classifications'', such as paints and pneumoconiosis and fibrous

producing dusts, that would no longer be appropriate with the

introduction of the ``particulates'' classification with the new

instantaneous-penetration test.

Derivation Table

The following derivation table lists: (1) Each section number of

the proposed rule (New Section); and (2) The section number of the

existing standard from which the proposed standard is derived (Old

Section).

Derivation Table

------------------------------------------------------------------------

New section Old section

------------------------------------------------------------------------

84.1............................... 11.1

84.2............................... 11.3

84.3............................... 11.4

84.4............................... New.

84.10.............................. 11.10

84.11.............................. 11.11

84.12.............................. 11.12

84.20.............................. 11.20

84.21.............................. 11.21

84.22.............................. 11.22

84.30.............................. 11.30

84.31.............................. 11.31

84.32.............................. 11.32

84.33.............................. 11.33

84.34.............................. 11.34

84.35.............................. 11.35

84.36.............................. 11.36

84.40.............................. 11.40

84.41.............................. 11.41

84.42.............................. 11.42

84.43.............................. 11.43

84.50.............................. 11.50

84.51.............................. 11.51

84.52.............................. 11.52

84.53.............................. 11.53

84.60.............................. 11.60

84.61.............................. 11.61

84.62.............................. 11.62

84.63.............................. 11.63

84.64.............................. 11.64

84.65.............................. 11.65

84.66.............................. 11.66

84.70.............................. 11.70

84.71.............................. 11.71

84.72.............................. 11.72

84.73.............................. 11.73

84.74.............................. 11.74

84.75.............................. 11.75

84.76.............................. 11.76

84.77.............................. 11.77

84.78.............................. 11.78

84.79.............................. 11.79

84.80.............................. 11.79-1

84.81.............................. 11.80

84.82.............................. 11.81

84.83.............................. 11.82

84.84.............................. 11.83

84.85.............................. 11.84

84.86.............................. 11.85-1

84.87.............................. 11.85-2

84.88.............................. 11.85-3

84.89.............................. 11.85-4

84.90.............................. 11.85-5

84.91.............................. 11.85-6

84.92.............................. 11.85-7

84.93.............................. 11.85-8

84.94.............................. 11.85-9

84.95.............................. 11.85-10

84.96.............................. 11.85-11

84.97.............................. 11.85-12

84.98.............................. 11.85-13

84.99.............................. 11.85-14

84.100............................. 11.85-15

84.101............................. 11.85-16

84.102............................. 11.85-17

84.103............................. 11.85-18

84.104............................. 11.85-19

84.110............................. 11.90

84.111............................. 11.91

84.112............................. 11.92

84.113............................. 11.93

84.114............................. 11.94

84.115............................. 11.95

84.116............................. 11.96

84.117............................. 11.97

84.118............................. 11.98

84.119............................. 11.99

84.120............................. 11.100

84.121............................. 11.101

84.122............................. 11.102-1

84.123............................. 11.102-2

84.124............................. 11.102-3

84.125............................. 11.102-4

84.126............................. 11.102-5

84.130............................. 11.110

84.131............................. 11.111

84.132............................. 11.112

84.133............................. 11.113

84.134............................. 11.114

84.135............................. 11.115

84.136............................. 11.116

84.137............................. 11.117

84.138............................. 11.118

84.139............................. 11.119

84.140............................. 11.120

84.141............................. 11.121

84.142............................. 11.122

84.143............................. 11.123

84.144............................. 11.124-1

84.145............................. 11.124-2

84.146............................. 11.124-3

84.147............................. 11.124-4

84.148............................. 11.124-5

84.149............................. 11.124-6

84.150............................. 11.124-7

84.151............................. 11.124-8

84.152............................. 11.124-9

84.153............................. 11.124-10

84.154............................. 11.124-11

84.155............................. 11.124-12

84.156............................. 11.124-13

84.157............................. 11.124-14

84.158............................. 11.124-15

84.159............................. 11.124-16

84.160............................. 11.124-17

84.161............................. 11.124-18

84.162............................. 11.124-19

84.163............................. 11.124-20

84.170............................. 11.130

84.171............................. 11.131

84.172............................. 11.132

84.173............................. 11.133

84.174............................. 11.134

84.175............................. 11.135

84.176............................. 11.136

84.177............................. 11.137

84.178............................. 11.138

84.179............................. 11.139

84.180............................. New.

84.181............................. 11.140-1

84.182............................. 11.140-2

84.183............................. 11.140.9

84.184............................. New.

84.185............................. New.

84.186............................. 11.140-10

84.190............................. 11.150

84.191............................. 11.151

84.192............................. 11.152

84.193............................. 11.153

84.194............................. 11.154

84.195............................. 11.155

84.196............................. 11.156

84.197............................. 11.157

84.198............................. 11.158

84.199............................. 11.158-1

84.200............................. 11.159

84.201............................. 11.160

84.202............................. 11.161

84.203............................. 11.162-1

84.204............................. 11.162-2

84.205............................. 11.162-3

84.206............................. 11.162-7

84.207............................. 11.162-8

84.250............................. 11.200

84.251............................. 11.201

84.252............................. 11.202

84.253............................. 11.203

84.254............................. 11.204

84.255............................. 11.205

84.256............................. 11.206

84.257............................. 11.207

84.258............................. 11.208

------------------------------------------------------------------------

Distribution Table

The following distribution table lists: (1) The section number of

the existing part 11 standard (Old Section); and (2) each section

number of the proposed rule (New Section).

Distribution Table

------------------------------------------------------------------------

Old section New section

------------------------------------------------------------------------

11.1............................... 84.1

11.2............................... Removed.

11.2-1............................. Removed.

11.3............................... 84.2

11.4............................... 84.3

11.10.............................. 84.10

11.11.............................. 84.11

11.12.............................. 84.12

11.20.............................. 84.20

11.21.............................. 84.21

11.22.............................. 84.22

11.30.............................. 84.30

11.31.............................. 84.31

11.32.............................. 84.32

11.33.............................. 84.33

11.34.............................. 84.34

11.35.............................. 84.35

11.36.............................. 84.36

11.40.............................. 84.40

11.41.............................. 84.41

11.42.............................. 84.42

11.43.............................. 84.43

11.50.............................. 84.50

11.51.............................. 84.51

11.52.............................. 84.52

11.53.............................. 84.53

11.60.............................. 84.60

11.61.............................. 84.61

11.62.............................. 84.62

11.63.............................. 84.63

11.64.............................. 84.64

11.65.............................. 84.65

11.66.............................. 84.66

11.70.............................. 84.70

11.71.............................. 84.71

11.72.............................. 84.72

11.73.............................. 84.73

11.74.............................. 84.74

11.75.............................. 84.75

11.76.............................. 84.76

11.77.............................. 84.77

11.78.............................. 84.78

11.79.............................. 84.79

11.79-1............................ 84.80

11.80.............................. 84.81

11.81.............................. 84.82

11.82.............................. 84.83

11.83.............................. 84.84

11.84.............................. 84.85

11.85.............................. Removed.

11.85-1............................ 84.86

11.85-2............................ 84.87

11.85-3............................ 84.88

11.85-4............................ 84.89

11.85-5............................ 84.90

11.85-6............................ 84.91

11.85-7............................ 84.92

11.85-8............................ 84.93

11.85-9............................ 84.94

11.85-10........................... 84.95

11.85-11........................... 84.96

11.85-12........................... 84.97

11.85-13........................... 84.98

11.85-14........................... 84.99

11.85-15........................... 84.100

11.85-16........................... 84.101

11.85-17........................... 84.102

11.85-18........................... 84.103

11.85-19........................... 84.104

11.90.............................. 84.110

11.91.............................. 84.111

11.92.............................. 84.112

11.93.............................. 84.113

11.94.............................. 84.114

11.95.............................. 84.115

11.96.............................. 84.116

11.97.............................. 84.117

11.98.............................. 84.118

11.99.............................. 84.119

11.100............................. 84.120

11.101............................. 84.121

11.102............................. Removed.

11.102-1........................... 84.122

11.102-2........................... 84.123

11.102-3........................... 84.124

11.102-4........................... 84.125

11.102-5........................... 84.126

11.110............................. 84.130

11.111............................. 84.131

11.112............................. 84.132

11.113............................. 84.133

11.114............................. 84.134

11.115............................. 84.135

11.116............................. 84.136

11.117............................. 84.137

11.118............................. 84.138

11.119............................. 84.139

11.120............................. 84.140

11.121............................. 84.141

11.122............................. 84.142

11.123............................. 84.143

11.124............................. Removed.

11.124-1........................... 84.144

11.124-2........................... 84.145

11.124-3........................... 84.146

11.124-4........................... 84.147

11.124-5........................... 84.148

11.124-6........................... 84.149

11.124-7........................... 84.150

11.124-8........................... 84.151

11.124-9........................... 84.152

11.124-10.......................... 84.153

11.124-11.......................... 84.154

11.124-12.......................... 84.155

11.124-13.......................... 84.156

11.124-14.......................... 84.157

11.124-15.......................... 84.158

11.124-16.......................... 84.159

11.124-17.......................... 84.160

11.124-18.......................... 84.161

11.124-19.......................... 84.162

11.124-20.......................... 84.163

11.124-21.......................... Removed.

11.124-22.......................... Removed.

11.124-23.......................... Removed.

11.124-24.......................... Removed.

11.130............................. 84.170

11.131............................. 84.171

11.132............................. 84.172

11.133............................. 84.173

11.134............................. 84.174

11.135............................. 84.175

11.136............................. 84.176

11.137............................. 84.177

11.138............................. 84.178

11.139............................. 84.179

11.140............................. Removed.

11.140-1........................... 84.181

11.140-2........................... 84.182

11.140-3........................... 84.183

11.140-4........................... Removed.

11.140-5........................... Removed.

11.140-6........................... Removed.

11.140-7........................... Removed.

11.140-8........................... Removed.

11.140-9........................... 84.183

11.140-10.......................... 84.146

11.140-11.......................... Removed.

11.140-12.......................... Removed.

11.150............................. 84.190

11.151............................. 84.191

11.152............................. 84.192

11.153............................. 84.193

11.154............................. 84.194

11.155............................. 84.195

11.156............................. 84.196

11.157............................. 84.197

11.158............................. 84.198

11.158-1........................... 84.199

11.159............................. 84.200

11.160............................. 84.201

11.161............................. 84.202

11.162............................. Removed.

11.162-1........................... 84.203

11.162-2........................... 84.204

11.162-3........................... 84.205

11.162-4........................... Removed.

11.162-5........................... Removed.

11.162-6........................... Removed.

11.162-7........................... 84.206

11.162-8........................... 84.207

11.170............................. Removed.

11.171............................. Removed.

11.172............................. Removed.

11.173............................. Removed.

11.174............................. Removed.

11.175............................. Removed.

11.176............................. Removed.

11.177............................. Removed.

11.178............................. Removed.

11.179............................. Removed.

11.180............................. Removed.

11.181............................. Removed.

11.182............................. Removed.

11.183............................. Removed.

11.183-1........................... Removed.

11.183-2........................... Removed.

11.183-3........................... Removed.

11.183-4........................... Removed.

11.183-5........................... Removed.

11.183-6........................... Removed.

11.183-7........................... Removed.

11.200............................. 84.250

11.201............................. 84.251

11.202............................. 84.252

11.203............................. 84.253

11.204............................. 84.254

11.205............................. 84.255

11.206............................. 84.256

11.207............................. 84.257

11.208............................. 84.258

------------------------------------------------------------------------

V. Executive Order 12866 and Regulatory Flexibility Act

Section 1 of Executive Order 12866 requires that before the

Department promulgates a new regulation, the need for the regulation

must be assessed, alternatives identified and assessed, the regulations

designed to achieve their objectives in the most cost-effective manner,

and, to the extent feasible, use performance standards. In addition,

Section 5 of the Order requires an assessment of the burden imposed by

existing regulations, to identify those that have become unjustified or

unnecessary as a result of changed circumstances. The Department is

proposing these changes in compliance with both sections of the

Executive Order.

The Department generally prepares a regulatory flexibility

analysis, in accordance with the Regulatory Flexibility Act, if the

rule is expected to have a significant impact on a substantial number

of small entities. That Act also requires that the Department

periodically review existing regulations and consider reforming those

that burden small entities, taking into account the degree to which

technology or other factors have changed in the area affected by the

rule.

The Department does not believe that this proposal is

``economically significant'' within the definition of E.O. 12866 (e.g.,

it would not have an effect on the economy of $100 million). Nor does

the Department believe that the proposal will have a significant impact

on a substantial number of small firms. However, it will create costs

for some firms in the respirator industry, and benefits for hospitals

and other entities using respirators. The magnitude of these effects is

uncertain. Accordingly, the Department has prepared the following

voluntary Initial Regulatory Flexibility Analysis.

Most employers rely on government standards to determine acceptable

levels of respirator performance. It would be inefficient and

unreasonably costly for each of millions of occasional purchasers of

these inexpensive devices to independently attempt to determine which

devices operate effectively to filter out minuscule particles.

This proposal will remove a regulatory impediment to the improved

design of respirators by substituting a performance standard for an

obsolete specifications standard. The practical effect of this will be

to enable firms to substitute a more effective and efficient filter

material in low-cost Class B and Class C respirators (respirators

already using high efficiency filters meeting Class A requirements will

not be affected by this proposal).

It is our understanding that substituting better filter material

will have negligible effects on the costs of filters, over the long

run. The material may cost very slightly more, but its cost will remain

measured in pennies per filter. NIOSH specifically solicits comments

and data for projected estimates of cost for materials and labor for

these improved respirators.

The demonstrated level of performance for filters will, however, be

substantially more effective. Instead of an efficiency rate of 95

percent for removing particles sized at 1 to 2 micrometers in diameter,

they will demonstrate the ability to remove particles of less than 1

micrometer in diameter at a typical efficiency rate of 95 to 99.97

percent. The importance of this change will vary considerably from

workplace setting to setting. However, in at least some settings the

benefits will be considerable.

For example, the classes of particulate filter respirators

certified under this rule will meet or exceed the CDC recommendations

for respiratory protective devices used for M. tuberculosis. Of the

currently NIOSH-certified respirators, only high-efficiency particulate

air (HEPA) filters meet or exceed these recommendations. The

certification to an enhanced performance level will create options for

the choice of respirators that adhere to CDC recommendations at reduced

expense. A disposable (one-time use) HEPA filter respirator generally

sells for around $7 to $10 and replaceable respirators equipped with

HEPA filters can cost $20 or more, with replacement filters costing

about $5 each. Replacement non-HEPA filters cost about $1 to $2 each.

Disposable non-HEPA filters cost about $1 to $8 each when purchased in

bulk.

The Department would expect similar effects--both improved health

and cost avoidance--in many other settings. The Department does not

have any basis at this time for quantifying either benefits or costs.

The Department does know that as many as seven million workers use

respirators at some time each year. NIOSH estimates that employers

annually purchase over 110 million disposable respirators. The

Department requests comments on potential savings in other settings.

There are approximately 35 manufacturers of these devices. NIOSH

believes that most of these already possess or have access to test

equipment needed to perform the new filter tests the Department

proposes to require. As is currently required under 30 CFR part 11,

NIOSH would continue to require that applicants conduct or have

conducted examinations, inspections, and tests of respirator

performance at least equivalent to those set by the respirator

certification tests. This is to assure that all necessary research and

development is conducted by the applicant prior to submitting an

application to the Federal Government for testing of the respirator by

NIOSH. For those manufacturers that do not currently possess this

capability, NIOSH estimates that the purchase of this equipment

represents an investment of approximately $60,000. Amortized over time,

this would not represent a significant cost for most manufacturers.

Filter materials are currently available that can be substituted

into present filter designs with minimal redesign (if any) to meet the

performance requirements of the new tests. Some currently NIOSH-

certified respirators have, when tested using the new standards,

demonstrated acceptable performance. Therefore, little or no cost will

be needed to develop suitable filtration materials or redesign existing

devices. However, the Department does realize that additional

development and redesign costs may be incurred to augment the presently

available products. NIOSH specifically requests relevant data and

comments on projected costs of redesign of respirators.

Notwithstanding these general conclusions, there may be some

manufacturers that will find it financially difficult, or a poor

investment, to meet the new standards. The Department would expect such

problems to result from free market competition rather than the

specific standards of these proposed regulations. That is, most

knowledgeable employers would purchase more cost-effective respirators

voluntarily and force major changes in the market if the present

regulatory barriers were removed. Nonetheless, there may be regulatory

alternatives that would minimize burdens on the smallest firms and the

Department welcomes suggestions for these.

List of Subjects in 42 CFR Part 84

Labeling, Mine safety and health, Occupational safety and health,

Personal protective equipment, Reporting and recordkeeping

requirements, Respirators.

Dated: February 14, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Approved: March 8, 1994.

Donna E. Shalala,

Secretary.

For the reasons set out in the preamble, 42 CFR part 84 is proposed

to be added to read as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Subpart A--General Provisions

Sec.

84.1 Purpose.

84.2 Definitions.

84.3 Incorporation by reference.

84.4 Respirators for mine rescue or other emergency use in mines.

Subpart B--Application for Approval

84.10 Application procedures.

84.11 Contents of application.

84.12 Delivery of respirators and components by applicant;

requirements.

Subpart C--Fees

84.20 Examination, inspection, and testing of complete respirator

assemblies; fees.

84.21 Examination, inspection, and testing of respirator components

or subassemblies; fees.

84.22 Unlisted fees; additional fees; payment by applicant prior to

approval.

Subpart D--Approval and Disapproval

84.30 Certificates of approval; scope of approval.

84.31 Certificates of approval; contents.

84.32 Notice of disapproval.

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

84.34 Revocation of certificates of approval.

84.35 Changes or modifications of approved respirators; issuance of

modification of certificate of approval.

84.36 Delivery of changed or modified approved respirator.

Subpart E--Quality Control

84.40 Quality control plans; filing requirements.

84.41 Quality control plans; contents.

84.42 Proposed quality control plans; approval by the Institute.

84.43 Quality control records; review by the Institute; revocation

of approval.

Subpart F--Classification of Approved Respirators; Scope of Approval;

Atmospheric Hazards; Service Time

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

84.51 Entry and escape, or escape only; classification.

84.52 Respiratory hazards; classification.

84.53 Service time; classification.

Subpart G--General Construction and Performance Requirements

84.60 Construction and performance requirements; general.

84.61 General construction requirements.

84.62 Component parts; minimum requirements.

84.63 Test requirements; general.

84.64 Pretesting by applicant; approval of test methods.

84.65 Conduct of examinations, inspections, and tests by the

Institute; assistance by applicant; observers; recorded data; public

demonstrations.

84.66 Withdrawal of applications; refund of fees.

Subpart H--Self-Contained Breathing Apparatus

84.70 Self-contained breathing apparatus; description.

84.71 Self-contained breathing apparatus; required components.

84.72 Breathing tubes; minimum requirements.

84.73 Harnesses; installation and construction; minimum

requirements.

84.74 Apparatus containers; minimum requirements.

84.75 Half-mask facepieces, full facepieces, mouthpieces; fit;

minimum requirements.

84.76 Facepieces; eyepieces; minimum requirements.

84.77 Inhalation and exhalation valves; minimum requirements.

84.78 Head harnesses; minimum requirements.

84.79 Breathing gas; minimum requirements.

84.80 Interchangeability of oxygen and air prohibited.

84.81 Compressed breathing gas and liquefied breathing gas

containers; minimum requirements.

84.82 Gas pressure gages; minimum requirements.

84.83 Timers; elapsed time indicators; remaining service life

indicators; minimum requirements.

84.84 Hand-operated valves; minimum requirements.

84.85 Breathing bags; minimum requirements.

84.86 Component parts exposed to oxygen pressures; minimum

requirements.

84.87 Compressed gas filters; minimum requirements.

84.88 Breathing-bag test.

84.89 Weight requirement.

84.90 Breathing resistance test; inhalation.

84.91 Breathing resistance test; exhalation.

84.92 Exhalation valve leakage test.

84.93 Gas flow test; open circuit apparatus.

84.94 Gas flow test; closed circuit apparatus.

84.95 Service-time test; open circuit apparatus.

84.96 Service-time test; closed circuit apparatus.

84.97 Test for carbon dioxide in inspired gas; open- and closed-

circuit apparatus; maximum allowable limits.

84.98 Tests during low temperature operation.

84.99 Man tests; testing conditions; general requirements.

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

84.101 Man test 5; requirements.

84.102 Man test 6; requirements.

84.103 Man tests; performance requirements.

84.104 Gas tightness test; minimum requirements.

Tables to Sub-Part H of Part 84

Subpart I--Gas Masks

84.110 Gas masks; description.

84.111 Gas masks; required components.

84.112 Canisters and cartridges in parallel; resistance

requirements.

84.113 Canisters and cartridges; color and markings; requirements.

84.114 Filters used with canisters and cartridges; location;

replacement.

84.115 Breathing tubes; minimum requirements.

84.116 Harnesses; installation and construction; minimum

requirements.

84.117 Gas mask containers; minimum requirements.

84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit;

minimum requirements.

84.119 Facepieces; eyepieces; minimum requirements.

84.120 Inhalation and exhalation valves; minimum requirements.

84.121 Head harnesses; minimum requirements.

84.122 Breathing resistance test; minimum requirements.

84.123 Exhalation valve leakage test.

84.124 Facepiece tests; minimum requirements.

84.125 Particulate tests; canisters containing particulate filters;

minimum requirements.

84.126 Canister bench tests; minimum requirements.

Tables to Subpart I of Part 84

Subpart J--Supplied-Air Respirators

84.130 Supplied-air respirators; description.

84.131 Supplied-air respirators; required components.

84.132 Breathing tubes; minimum requirements.

84.133 Harnesses; installation and construction; minimum

requirements.

84.134 Respirator containers; minimum requirements.

84.135 Half-mask facepieces, full facepieces, hoods, and helmets;

fit; minimum requirements.

84.136 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.137 Inhalation and exhalation valves; check valves; minimum

requirements.

84.138 Head harnesses; minimum requirements.

84.139 Head and neck protection; supplied-air respirators; minimum

requirements.

84.140 Air velocity and noise levels; hoods and helmets; minimum

requirements.

84.141 Breathing gas; minimum requirements.

84.142 Air supply source; hand-operated or motor driven air

blowers; Type A supplied-air respirators; minimum requirements.

84.143 Terminal fittings or chambers; Type B supplied-air

respirators; minimum requirements.

84.144 Hand-operated blower test; minimum requirements.

84.145 Motor-operated blower test; minimum requirements.

84.146 Method of measuring the power and torque required to operate

blowers.

84.147 Type B supplied-air respirator; minimum requirements.

84.148 Type C supplied-air respirator, continuous-flow class;

minimum requirements.

84.149 Type C supplied-air respirator, demand and pressure demand

class; minimum requirements.

84.150 Air-supply line tests; minimum requirements.

84.151 Harness test; minimum requirements.

84.152 Breathing tube test; minimum requirements.

84.153 Airflow resistance test, Type A and Type AE supplied-air

respirators; minimum requirements.

84.154 Airflow resistance test; Type B and Type BE supplied-air

respirators; minimum requirements.

84.155 Airflow resistance test; Type C supplied-air respirator,

continuous flow class and Type CE supplied-air respirator; minimum

requirements.

84.156 Airflow resistance test; Type C supplied-air respirator,

demand class; minimum requirements.

84.157 Airflow resistance test; Type C supplied-air respirator,

pressure-demand class; minimum requirements.

84.158 Exhalation valve leakage test.

84.159 Man tests for gases and vapors; supplied-air respirators;

general performance requirements.

84.160 Man tests for gases and vapors; Type A and Type AE

respirators; test requirements.

84.161 Man tests for gases and vapors; Type B and Type BE

respirators; test requirements.

84.162 Man test for gases and vapors; Type C respirators,

continuous-flow class and Type CE supplied-air respirators; test

requirements.

84.163 Man test for gases and vapors; Type C supplied-air

respirators, demand and pressure-demand classes; test requirements.

Tables to Subpart J of Part 84

Subpart K--Particulate Respirators

84.170 Particulate respirators; description.

84.171 Particulate respirators; required components.

84.172 Breathing tubes; minimum requirements.

84.173 Harnesses; installation and construction; minimum

requirements.

84.174 Respirator containers; minimum requirements.

84.175 Half-mask facepieces, full facepieces, hoods, helmets, and

mouthpieces; fit; minimum requirements.

84.176 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.177 Inhalation and exhalation valves; minimum requirements.

84.178 Head harnesses; minimum requirements.

84.179 Air velocity and noise levels; hoods and helmets; minimum

requirements.

84.180 Particulate respirators; filter type identification.

84.181 Isoamyl acetate tightness test; particulate respirators with

filters not intended to be replaced.

84.182 Isoamyl acetate tightness test; respirators with replaceable

filters; minimum requirements.

84.183 Airflow resistance tests.

84.184 Particulate instantaneous-penetration-filter test.

84.185 Powered, particulate respirator flow requirements.

84.186 Exhalation valve leakage test; minimum requirements.

Subpart L--Chemical Cartridge Respirators

84.190 Chemical cartridge respirators; description.

84.191 Chemical cartridge respirators; required components.

84.192 Cartridges in parallel; resistance requirements.

84.193 Cartridges; color and markings; requirements.

84.194 Filters used with chemical cartridges; location;

replacement.

84.195 Breathing tubes; minimum requirements.

84.196 Harnesses; installation and construction; minimum

requirements.

84.197 Respirator containers; minimum requirements.

84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods,

and helmets; fit; minimum requirements.

84.199 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.200 Inhalation and exhalation valves; minimum requirements.

84.201 Head harnesses; minimum requirements.

84.202 Air velocity and noise levels; hoods and helmets; minimum

requirements.

84.203 Breathing resistance test; minimum requirements.

84.204 Exhalation valve leakage test; minimum requirements.

84.205 Facepiece test; minimum requirements.

84.206 Particulate tests; respirators with filters; minimum

requirements; general.

84.207 Bench tests; gas and vapor tests; minimum requirements;

general.

Tables to Subpart L of Part 84

Subpart M--[Reserved]

Subpart N--Special Use Respirators

84.250 Vinyl chloride respirators; description.

84.251 Required components.

84.252 Gas masks; requirements and tests.

84.253 Chemical-cartridge respirators; requirements and tests.

84.254 Powered air-purifying respirators; requirements and tests.

84.255 Requirements for end-of-service-life indicator.

84.256 Quality control requirements.

84.257 Labeling requirements.

84.258 Fees.

Authority: 29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C. 3,

5, 7, 811, 842(h), 844.

Subpart A--General Provisions

Sec. 84.1 Purpose.

The purpose of the regulations contained in this part 84 is:

(a) To establish procedures and prescribe requirements which must

be met in filing applications for approval by the National Institute

for Occupational Safety and Health of respirators or changes or

modifications of approved respirators;

(b) To establish a schedule of fees to be charged each applicant

for the inspections, examinations, and testing conducted by the

Institute under the provisions of this part;

(c) To provide for the issuance of certificates of approval or

modifications of certificates of approval for respirators which have

met the applicable construction, performance, and respiratory

protection requirements set forth in this part; and

(d) To specify minimum requirements and to prescribe methods to be

employed by the Institute and by the applicant in conducting

inspections, examinations, and tests to determine the effectiveness of

respirators used during entry into or escape from hazardous

atmospheres.

Sec. 84.2 Definitions.

As used in this part--

(a) Applicant means an individual, partnership, company,

corporation, association, or other organization that designs,

manufactures, assembles, or controls the assembly of a respirator and

who seeks to obtain a certificate of approval for such respirator.

(b) Approval means a certificate or formal document issued by the

Institute stating that an individual respirator or combination of

respirators has met the minimum requirements of this part 84, and that

the applicant is authorized to use and attach an approval label to any

respirator, respirator container, or instruction card for any

respirator manufactured or assembled in conformance with the plans and

specifications upon which the approval was based, as evidence of such

approval.

(c) Approved means conforming to the minimum requirements of this

part 84.

(d) Auxiliary equipment means a self-contained breathing apparatus,

the use of which is limited in underground mine rescue and recovery

operations to situations where the wearer has ready access to fresh air

and at least one crew equipped with approved self-contained breathing

apparatus of 2 hours or longer rating, is in reserve at a fresh-air

base.

(e) Certification and Quality Assurance Branch means the

Certification and Quality Assurance Branch, Division of Safety

Research, Appalachian Laboratory for Occupational Safety and Health,

National Institute for Occupational Safety and Health, 944 Chestnut

Ridge Road, Morgantown, West Virginia 26505-2888.

(f) Compressed-breathing gas means oxygen or air stored in a

compressed state and supplied to the wearer in gaseous form.

(g) dBA means sound pressure levels in decibels, as measured with

the A-weighted network of a standard sound level meter using slow

response.

(h) Dust means a solid mechanically produced particle with a size

ranging from submicroscopic to macroscopic.

(i) Respirators for entry into and escape from means respiratory

devices providing protection during entry into and escape from

hazardous atmospheres.

(j) Respirators for escape only means respiratory devices providing

protection only during escape from hazardous atmospheres.

(k) A facepiece or mouthpiece is a respirator component designed to

provide a gas-tight or dust-tight fit with the face and may include

headbands, valves, and connections for canisters, cartridges, filters,

or respirable gas source.

(l) Final inspection means that activity carried out on a product

after all manufacturing and assembly operations are completed to insure

completeness and adherence to performance or other specifications,

including satisfactory appearance.

(m) Fume means a solid condensation particle, generally less than 1

micrometer in diameter.

(n) Gas means an aeriform fluid which is in a gaseous state at

ordinary temperature and pressure.

(o) Hazardous atmosphere means:

(1) Any atmosphere containing a toxic or disease producing gas,

vapor, dust, fume, mist, or pesticide, either immediately or not

immediately dangerous to life or health; or

(2) Any oxygen-deficient atmosphere.

(p) A hood or helmet is a respirator component which covers the

wearer's head and neck, or head, neck, and shoulders, and is supplied

with incoming respirable air for the wearer to breathe. It may include

a headharness and connection for a breathing tube.

(q) Immediately dangerous to life or health means conditions that

pose an immediate threat to life or health or conditions that pose an

immediate threat of severe exposure to contaminants, such as

radioactive materials, which are likely to have adverse cumulative or

delayed effects on health.

(r) Incoming inspection means the activity of receiving, examining,

and accepting only those materials and parts whose quality conforms to

specification requirements.

(s) In-process inspection means the control of products at the

source of production and at each step of the manufacturing process, so

that departures from specifications can be corrected before defective

components or materials are assembled into the finished product.

(t) Institute means the National Institute for Occupational Safety

and Health, Department of Health and Human Services.

(u) Liquefied-breathing gas means oxygen or air stored in liquid

form and supplied to the wearer in a gaseous form.

(v) Mist means a liquid condensation particle with a size ranging

from submicroscopic to macroscopic.

(w) MSHA means the Mine Safety and Health Administration, U.S.

Department of Labor.

(x) Not immediately dangerous to life or health means any hazardous

atmosphere which may produce physical discomfort immediately, chronic

poisoning after repeated exposure, or acute adverse physiological

symptoms after prolonged exposure.

(y) Oxygen-deficient atmosphere means an atmosphere which contains

an oxygen partial pressure of less than 148 millimeters of mercury

(19.5 percent by volume at sea level).

(z) Powered air-purifying respirator means a device equipped with a

facepiece, hood, or helmet, breathing tube, canister, cartridge,

filter, canister with filter, or cartridge with filter, and a blower.

(aa) Respirator means any device designed to provide the wearer

with respiratory protection against inhalation of a hazardous

atmosphere.

(bb) Single-use respirator means a respirator that is entirely

discarded after excessive resistance, sorbent exhaustion, or physical

damage renders it unsuitable for further use.

(cc) Vapor means the gaseous state of a substance that is solid or

liquid at ordinary temperature and pressure.

Sec. 84.3 Incorporation by reference.

Note: The technical publications referenced in this part 84,

which have been prepared by organizations other than the Institute,

were approved for incorporation by reference in 30 CFR part 11. The

Institute will be submitting these publications for approval of the

incorporation by reference by the Director of the Office of the

Federal Register under this part 84 prior to the publication of a

final rule.

Sec. 84.4 Respirators for mine rescue or other emergency use in mines.

(a) (1) NIOSH and the Mine Safety and Health Administration (MSHA),

U.S. Department of Labor, shall jointly review and issue certifications

for respirators used for mine emergencies and mine rescue, including

any associated service-life plans, users' manuals and other supporting

documentation.

(2) Each certification for a respirator designed for mine rescue or

other emergency use in mines shall include, as a condition of approval,

any use limitations related to mine safety and health.

(b) NIOSH and MSHA shall jointly determine appropriate recall and

retrofit remedies for field complaints or identified deficiencies

involving any respirators used in the mining environment.

Subpart B--Application for Approval

Sec. 84.10 Application procedures.

(a) Inspection, examination, and testing leading to the approval of

the types of respirators classified in subpart F of this part shall be

undertaken by the Institute only pursuant to written applications which

meet the minimum requirements set forth in this subpart B.

(b) Applications shall be submitted to the Certification and

Quality Assurance Branch, and shall be accompanied by a check, bank

draft, or money order in the amount specified in subpart C of this

part, payable to the order of the National Institute for Occupational

Safety and Health.

(c) Except as provided in Sec. 84.64, the examination, inspection,

and testing of all respirators shall be conducted by the Certification

and Quality Assurance Branch.

(d) Applicants, manufacturers, or their representatives may visit

or communicate with the Certification and Quality Assurance Branch in

order to discuss the requirements for approval of any respirator or the

proposed designs thereof. No charge shall be made for such consultation

and no written report shall be issued to applicants, manufacturers, or

their representatives by the Institute as a result of such

consultation.

(e) Respirators having electrical or electronic components that are

required to be permissible under chapter I of title 30 shall be tested

in accordance with 30 CFR part 18. Applications for approval of such

respirators by MSHA shall be submitted in writing to: MSHA, Approval

and Certification Center, Box 251, Industrial Park Road, Triadelphia,

West Virginia 26059.

Sec. 84.11 Contents of application.

(a) Each application for approval shall contain a complete written

description of the respirator for which approval is requested together

with drawings and specifications (and lists thereof) showing full

details of construction of the respirator and of the materials used.

(b) Drawings shall be titled, numbered, and dated; any revision

dates shall be shown on the drawings, and the purpose of each revision

being sought shall be shown on the drawing or described on an

attachment to the drawing to which it applies.

(c) Each application for approval shall contain a proposed plan for

quality control which meets the minimum requirements set forth in

subpart E of this part.

(d) Each application shall contain a statement that the respirator

has been pretested by the applicant as prescribed in Sec. 84.64, and

shall include the results of such tests.

(e) Each application for approval shall contain a statement that

the respirator and component parts submitted for approval are either

prototypes, or made on regular production tooling, with no operation

included which will not be incorporated in regular production

processing.

Sec. 84.12 Delivery of respirators and components by applicant;

requirements.

(a) Each applicant shall, when an application is filed pursuant to

Sec. 84.10, be advised by the Institute of the total number of

respirators and component parts required for testing.

(b) The applicant shall deliver, at his own expense, the number of

completely assembled respirators and component parts required for

testing, to the Certification and Quality Assurance Branch.

(c) Respirators and component parts submitted for approval must be

made from materials specified in the application.

(d) One completely assembled respirator approved under the

provisions of this part may be retained by the Institute as a

laboratory exhibit, the remaining respirators may be returned to the

applicant at his own expense, upon written request within 30 days after

notice of approval. If no such request is made, the respirators will be

disposed of by the Institute in such manner as it deems appropriate.

(e) Where a respirator fails to meet the requirements for approval

set forth in this part, all respirators and components delivered in

accordance with this section may be returned to the applicant at his

own expense, upon written request within 30 days after notice of

disapproval. If no such request is made, the respirators will be

disposed of by the Institute in such manner as it deems appropriate.

Subpart C--Fees

Sec. 84.20 Examination, inspection, and testing of complete respirator

assemblies; fees.

Except as provided in Sec. 84.22, the following fees shall be

charged by the Institute for the examination, inspection and testing of

complete respirator assemblies:

Self-contained breathing apparatus:

Entry and escape, 1 hour or more............................ $3,500

Entry and escape, less than 1 hour.......................... 2,750

Escape only................................................. 2,000

Gas masks:

Single hazard............................................... 1,100

Type N...................................................... 4,100

Supplied-air respirators...................................... 750

Particulate respirators:

All Types................................................... 1,250

Chemical cartridge respirators................................ 1,150

Sec. 84.21 Examination, inspection, and testing of respirator

components or subassemblies; fees.

Except as provided in Sec. 84.22, the following fees shall be

charged by the Institute for the examination, inspection and testing of

the individual respirator components or subassemblies:

Facepieces...................................................... $450

Canisters....................................................... 900

Cartridges...................................................... 600

Filters......................................................... 650

Hoses........................................................... 250

Blowers......................................................... 250

Harnesses....................................................... 100

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

to approval.

(a) Applications for the examination, inspection and testing of

complete respirator assemblies which are not listed in Sec. 84.20, or

for the examination, inspection, and testing of respirator components

or subassemblies which are not listed in Sec. 84.21, shall be

accompanied by the following deposits:

Complete respirator assembly.................................. $1,500

Each individual component or subassembly...................... 500

(b) The Institute reserves the right to conduct any examination,

inspection, or test it deems necessary to determine the quality and

effectiveness of any listed or unlisted respirator assembly or

respirator component or subassembly, and to assess the cost of such

examinations, inspections, or tests against the applicant prior to the

issuance of any approval for such assembly, component, or subassembly.

(c) The fees charged for the examination, inspection, and testing

of unlisted respirator assemblies, unlisted individual respirator

components or subassemblies, and for the additional examination,

inspection, and testing of listed respirator assemblies and components

or subassemblies shall be at the rate of $100 per day for each man-day

required to be expended by the Institute.

(d) Upon completion of all examinations, inspections, and tests of

unlisted respirator assemblies or components, or following the

completion of any additional examination, inspections, or tests of

listed assemblies, or components or subassemblies, including retesting

subsequent to disapproval, the Institute shall advise the applicant in

writing of the total cost assessed and the additional amount, if any,

which must be paid to the Institute as a condition of approval.

(e) In the event the amount assessed by the Institute for unlisted

assemblies, or components or subassemblies is less than the amount of

the deposit submitted in accordance with paragraph (a) of this section,

the Institute shall refund the overpayment upon the issuance of any

approval or notice of disapproval.

Subpart D--Approval and Disapproval

Sec. 84.30 Certificates of approval; scope of approval.

(a) The Institute shall issue certificates of approval pursuant to

the provisions of this subpart only for individual, completely

assembled respirators which have been examined, inspected, and tested,

and which meet the minimum requirements set forth in subparts H through

L of this part, as applicable.

(b) The Institute will not issue certificates of approval for any

respirator component or for any respirator subassembly.

(c) The Institute shall not issue an informal notification of

approval. However, if the application for approval, submitted in

accordance with Sec. 84.11, states that the submitted respirator and

component parts are only prototypes, the Institute will examine,

inspect, and test such respirator and component parts in accordance

with the provisions of this part 84. If, upon completion of such

examinations, inspections and tests, it is found that the prototype

meets the minimum requirements set forth in this part, the Institute

may inform the applicant, in writing, of the results of the

examinations, inspections, and tests, and may require him to resubmit

respirators and component parts made on regular production tooling,

with no operations included which will not be incorporated in regular

production processing, for further examination, inspection, and

testing, prior to issuance of the certificate of approval.

(d) Applicants required to resubmit respirators and component parts

made on regular production tooling, with no operation included which

will not be incorporated in regular production processing, shall be

charged fees in accordance with subpart C of this part.

Sec. 84.31 Certificates of approval; contents.

(a) The certificate of approval shall contain a classification and

a description of the respirator or combination of respirators for which

it is issued, as provided in this part.

(b) The certificate of approval shall specifically set forth any

restrictions or limitations on the respirator's use in hazardous

atmospheres.

(c) Each certificate of approval shall be accompanied by the

drawings and specifications (and lists thereof) submitted by the

applicant in accordance with Sec. 84.11. These drawings and

specifications shall be referenced in the certificate of approval, and

shall be maintained by the applicant. The drawings and specifications

listed in each certificate of approval shall set forth in detail the

design and construction requirements which shall be met by the

applicant during commercial production of the respirator.

(d) Each certificate of approval shall be accompanied by a

reproduction of the approval label design to be employed by the

applicant with each approved respirator, as provided in Sec. 84.33.

(e) No test data or specific laboratory findings will accompany any

certificate of approval, however, the Institute will release pertinent

test data and specific findings upon written request by the applicant,

or as required by statute or regulation.

(f) Each certificate of approval shall also contain the approved

quality control plan as specified in Sec. 84.42.

Sec. 84.32 Notice of disapproval.

(a) If, upon the completion of the examinations, inspections, and

tests required to be conducted in accordance with the provisions of

this part, it is found that the respirator does not meet the minimum

requirements set forth in this part, the Institute shall issue a

written notice of disapproval to the applicant.

(b) Each notice of disapproval shall be accompanied by all

pertinent data or findings with respect to the defects of the

respirator for which approval was sought with a view to the possible

correction of any such defects.

(c) The Institute shall not disclose, except to the applicant or as

required by statute or regulation, any data, findings, or other

information with respect to any respirator for which a notice of

disapproval is issued.

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

(a) Full-scale reproductions of approval labels and markings, and a

sketch or description of the method of application and position on the

harness, container, canister, cartridge, filter, or other component,

together with instructions for the use and maintenance of the

respirator shall be submitted to the Institute for approval.

(b) Approval labels shall bear the emblem of the National Institute

for Occupational Safety and Health and the seal of the Department of

Health and Human Services, the applicant's name and address, an

approval number assigned by the Institute and, where appropriate,

restrictions or limitations placed upon the use of the respirator by

the Institute. The approval number assigned by the Institute shall be

designated by the prefix TC and a serial number.

(c) The Institute shall, where necessary, notify the applicant when

additional labels, markings, or instructions will be required.

(d) Approval labels and markings shall only be used by the

applicant to whom they were issued.

(e) Legible reproductions or abbreviated forms of the label

approved by the Institute for use on each respirator shall be attached

to or printed at the following locations:

------------------------------------------------------------------------

Respirator type Label type Location

------------------------------------------------------------------------

Self-contained Entire.................... Harness assembly and

breathing apparatus. canister (where

applicable).

Gas mask............. Entire.................... Mask container and

canister.

Supplied air ......do.................. Respirator container

respirator. or instruction card.

Particulate ......do.................. Respirator container

respirator. and filter

container.

Abbreviated............... Filters.

Chemical-cartridge Entire.................... Respirator container,

respirator. cartridge container,

and filter

containers (where

applicable).

Abbreviated............... Cartridges and

filters and filter

containers.

------------------------------------------------------------------------

(f) The use of any Institute approval label obligates the applicant

to whom it is issued to maintain or cause to be maintained the approved

quality control sampling schedule and the acceptable quality level for

each characteristic tested, and to assure that it is manufactured

according to the drawings and specifications upon which the certificate

of approval is based.

(g) Each respirator, respirator component, and respirator container

shall, as required by the Institute to assure quality control and

proper use of the respirator, be labeled distinctly to show the name of

the applicant, and the name and letters or numbers by which the

respirator or respirator component is designated for trade purposes,

and the lot number, serial number, or approximate date of manufacture.

Sec. 84.34 Revocation of certificates of approval.

The Institute reserves the right to revoke, for cause, any

certificate of approval issued pursuant to the provisions of this part.

Such causes include, but are not limited to, misuse of approval labels

and markings, misleading advertising, and failure to maintain or cause

to be maintained the quality control requirements of the certificate of

approval.

Sec. 84.35 Changes or modification of approved respirators; issuance

of modification of certificate of approval.

(a) Each applicant may, if he desires to change any feature of an

approved respirator, request a modification of the original certificate

of approval issued by the Institute for such respirator by filing an

application for such modification in accordance with the provisions of

this section.

(b) Applications shall be submitted as for an original certificate

of approval, with a request for a modification of the existing

certificate to cover any proposed change.

(c) The application shall be accompanied by appropriate drawings

and specifications, and by a proposed quality control plan which meets

the requirements of subpart E of this part.

(d) The application for modification together with the accompanying

material, shall be examined by the Institute to determine whether

testing will be required.

(e) The Institute shall inform the applicant of the fee required

for any additional testing and the applicant will be charged for the

actual cost of any examination, inspection, or test required, and such

fees shall be submitted in accordance with the provisions of subpart C

of this part.

(f) If the proposed change or modification meets the requirements

of this part, a formal certificate of modification will be issued,

accompanied, where necessary, by a list of new and revised drawings and

specifications covering the change(s) and reproductions of revised

approval labels.

Sec. 84.36 Delivery of changed or modified approved respirator.

An approved respirator for which a formal certificate of

modification has been issued shall be delivered, with proper markings

and containers, by the applicant to the Certification and Quality

Assurance Branch, as soon as it is commercially produced.

Subpart E--Quality Control

Sec. 84.40 Quality control plans; filing requirements.

As a part of each application for approval or modification of

approval submitted pursuant to this part, each applicant shall file

with the Institute a proposed quality control plan which shall be

designed to assure the quality of respiratory protection provided by

the respirator for which approval is sought.

Sec. 84.41 Quality control plans; contents.

(a) Each quality control plan shall contain provisions for the

management of quality, including:

(1) Requirements for the production of quality data and the use of

quality control records;

(2) Control of engineering drawings, documentations, and changes;

(3) Control and calibration of measuring and test equipment;

(4) Control of purchased material to include incoming inspection;

(5) Lot identification, control of processes, manufacturing,

fabrication, and assembly work conducted in the applicant's plant;

(6) Audit of final inspection of the completed product; and,

(7) The organizational structure necessary to carry out these

provisions.

(b) Each provision for incoming and final inspection in the quality

control plan shall include a procedure for the selection of a sample of

respirators and the components thereof for testing, in accordance with

procedures set forth in Military Standard MIL-STD-105D, ``Sampling

Procedures and Tables for Inspection by Attributes,'' or Military

Standard MIL-STD-414, ``Sampling Procedures and Tables for Inspection

by Variables for Percent Defective,'' or an approved equivalent

sampling procedure, or an approved combination of sampling procedures.

Incoming bulk raw material inspection or verification of specification,

and in-process inspection shall be sufficient to ensure control of

product quality through the manufacturing cycle.

(c) The sampling procedure shall include a list of the

characteristics to be tested by the applicant or his agent.

(d) The characteristics listed in accordance with paragraph (c) of

this section shall be classified according to the potential effect of

such defect and grouped into the following classes:

(1) Critical. A defect that judgment and experience indicate is

likely to result in a condition immediately hazardous to life or health

for individuals using or depending upon the respirator;

(2) Major A. A defect, other than critical, that is likely to

result in failure to the degree that the respirator does not provide

any respiratory protection, or a defect that reduces protection and is

not detectable by the user;

(3) Major B. A defect, other than Major A or critical, that is

likely to result in reduced respiratory protection, and is detectable

by the user; and

(4) Minor. A defect that is not likely to materially reduce the

usability of the respirator for its intended purpose, or a defect that

is a departure from established standards and has little bearing on the

effective use or operation of the respirator.

(e) The quality control inspection test method to be used by the

applicant or his agent for each characteristic required to be tested

shall be described in detail.

(f) Each item manufactured shall be 100 percent inspected for

defects in all critical characteristics and all defective items shall

be rejected.

(g) The Acceptable Quality Level (AQL) for each major or minor

defect so classified by the applicant shall be:

(1) Major A. 1.0 percent;

(2) Major B. 2.5 percent; and

(3) Minor. 4.0 percent.

(h) Except as provided in paragraph (i) of this section, inspection

level II as described in MIL-STD-105D, or inspection level IV as

described in MIL-STD-414, shall be used for major and minor

characteristics and 100 percent inspection for critical

characteristics.

(i) Subject to the approval of the Institute, where the quality

control plan provisions for raw material, processes, manufacturing, and

fabrication, inspections are adequate to insure control of finished

article quality, destructive testing of finished articles may be

conducted at a lower level of inspection than that specified in

paragraph (h) of this section.

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

(a) Each proposed quality control plan submitted in accordance with

this subpart shall be reviewed by the Institute to determine its

effectiveness in insuring the quality of respiratory protection

provided by the respirator for which an approval is sought.

(b) If the Institute determines that the proposed quality control

plan submitted by the applicant will not insure adequate quality

control, the Institute shall require the applicant to modify the

procedures and testing requirements of the plan prior to approval of

the plan and issuance of any certificate of approval.

(c) Approved quality control plans shall constitute a part of and

be incorporated into any certificate of approval issued by the

Institute, and compliance with such plans by the applicant shall be a

condition of approval.

Sec. 84.43 Quality control records; review by the Institute;

revocation of approval.

(a) The applicant shall keep quality control inspection records

sufficient to carry out the procedures required in MIL-STD-105D or MIL-

STD-414, or an approved equivalent sampling procedure.

(b) The Institute reserves the right to have its representatives

inspect the applicant's quality control test methods, equipment, and

records, and to interview any employee or agent of the applicant in

regard to quality control test methods, equipment, and records.

(c) The Institute reserves the right to revoke, for cause any

certificate of approval where it is found that the applicant's quality

control test methods, equipment, or records do not insure effective

quality control over the respirator for which the approval was issued.

Subpart F--Classification of Approved Respirators; Scope of

Approval; Atmospheric Hazards; Service Time

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

Approvals shall be issued for the types of respirators which have

been classified pursuant to this subpart F, have been inspected,

examined and tested by the Institute, in accordance with the provisions

of subparts G through L of this part, and have been found to provide

respiratory protection for fixed periods of time against the hazards

specified in such approval.

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

Respirators described in subparts H through L of this part shall be

classified for use as follows:

(a) Entry and escape. Respirators designed and approved for use

during entry into a hazardous atmosphere, and for escape from a

hazardous atmosphere; or

(b) Escape only. Respirators designed and approved for use only

during escape from a hazardous atmosphere.

Sec. 84.52 Respiratory hazards; classification.

Respirators described in subparts H through L of this part shall be

classified as approved for use against any or all of the following

respiratory hazards:

(a) Oxygen deficiency;

(b) Gases and vapors; and

(c) Particles, including dusts, fumes and mists.

Sec. 84.53 Service time; classification.

(a) Respirators described in subparts H through L of this part

shall be classified, where applicable, as approved for use during the

following prescribed service times:

(1) Four hours;

(2) Three hours;

(3) Two hours;

(4) One hour;

(5) Forty-five minutes;

(6) Thirty minutes;

(7) Fifteen minutes;

(8) Ten minutes;

(9) Five minutes; or

(10) Three minutes.

(b) Other service times may be prescribed by the Institute.

Subpart G--General Construction and Performance Requirements

Sec. 84.60 Construction and performance requirements; general.

(a) The Institute shall issue approvals for the types of

respirators described in subparts H through L of this part which have

met the minimum requirements set forth for such respirators in this

part 84.

(b) In addition to the types of respirators specified in subparts H

through L of this part, the Institute shall issue approvals for other

respiratory protective devices not specifically described in this part

84 subject to such additional requirements as may be imposed in

accordance with Sec. 84.63(c).

Sec. 84.61 General construction requirements.

(a) Respirators will not be accepted by the Institute for

examination, inspection and testing unless they are designed on sound

engineering and scientific principles, constructed of suitable

materials and evidence good workmanship.

(b) Respirator components which come into contact with the wearer's

skin shall be made of nonirritating materials.

(c) Components replaced during or after use shall be constructed of

materials which will not be damaged by normal handling.

(d) Mouthpieces, hoods, helmets, and facepieces, except those

employed in single-use respirators, shall be constructed of materials

which will withstand repeated disinfection as recommended by the

applicant in his instructions for use of the device.

Sec. 84.62 Component parts; minimum requirements.

(a) The component parts of each respirator shall be:

(1) Designed, constructed, and fitted to insure against creation of

any hazard to the wearer;

(2) Assembled to permit easy access for inspection and repair of

functional parts; and

(3) Assembled to permit easy access to parts which require periodic

cleaning and disinfecting.

(b) Replacement parts shall be designed and constructed to permit

easy installation and to maintain the effectiveness of the respirator.

Sec. 84.63 Test requirements; general.

(a) Each respirator and respirator component shall when tested by

the applicant and by the Institute, meet the applicable requirements

set forth in subparts H through L of this part.

(b) Where a combination respirator is assembled from two or more

types of respirators, as described in this part, each of the individual

respirator types which have been combined shall, as applicable, meet

the minimum requirements for such respirators set forth in subparts H

through L of this part, and such combination respirators, except as

specified in Sec. 84.70(b)(2), will be classified by the type of

respirator in the combination which provides the least protection to

the user.

(c) In addition to the minimum requirements set forth in subparts H

through L of this part, the Institute reserves the right to require, as

a further condition of approval, any additional requirements deemed

necessary to establish the quality, effectiveness, and safety of any

respirator used as protection against hazardous atmospheres.

(d) Where it is determined after receipt of an application that

additional requirements will be required for approval, the Institute

will notify the applicant in writing of these additional requirements,

and necessary examinations, inspections, or tests, stating generally

the reasons for such requirements, examinations, inspections, or tests.

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

(a) Prior to making or filing any application for approval or

modification of approval, the applicant shall conduct, or cause to be

conducted, examinations, inspections, and tests of respirator

performance which are equal to or exceed the severity of those

prescribed in this part.

(b) With the application, the applicant shall provide a statement

to the Institute showing the types and results of the examinations,

inspections, and tests required under paragraph (a) of this section and

state that the respirator meets the minimum requirements of subparts H

through L of this part, as applicable. Complete examination,

inspection, and test data shall be retained on file by the applicant

and be submitted, upon request, to the Institute.

(c) The Institute may, upon written request by the applicant,

provide drawings and descriptions of its test equipment and otherwise

assist the applicant in establishing a test laboratory or securing the

services of a testing agency.

(d) No approval will be issued until the Institute has validated

the applicant's test results.

Sec. 84.65 Conduct of examinations, inspections, and tests by the

Institute; assistance by applicant; observers; recorded data; public

demonstrations.

(a) All examinations, inspections, and tests conducted pursuant to

subparts H through L of this part will be under the sole direction and

control of the Institute.

(b) The Institute may, as a condition of approval, require the

assistance of the applicant or agents of the applicant during the

assembly, disassembly, or preparation of any respirator or respirator

component prior to testing or in the operation of such equipment during

testing.

(c) Only Institute personnel, persons assisting the Institute

pursuant to paragraph (b) of this section, and such other persons as

are requested by the Institute or the applicant to be observers, shall

be present during any examination, inspection, or test conducted prior

to the issuance of an approval by the Institute for the equipment under

consideration.

(d) The Institute shall hold as confidential any analyses,

drawings, specifications, or materials submitted by the applicant and

shall not disclose any principles or patentable features of such

equipment, except as required by statute or regulation.

(e) As a condition of each approval issued for any respirator, the

Institute reserves the right, following the issuance of such approval,

to conduct such public tests and demonstrations of the approved

respiratory equipment as is deemed appropriate.

Sec. 84.66 Withdrawal of applications; refund of fees.

(a) Any applicant may, upon a written request submitted to the

Institute, withdraw any application for approval of any respirator.

(b) Upon receipt of a written request for the withdrawal of an

application, the Institute shall determine the total man-days expended

and the amount due for services already performed during the course of

any examinations, inspections, or tests conducted pursuant to such

application. The total amount due shall be determined in accordance

with the provisions of Sec. 84.22 and assessed against the fees

submitted by the applicant. If the total amount assessed is less than

the fees submitted, the Institute shall refund the balance together

with a statement of the charges made for services rendered.

Subpart H--Self-Contained Breathing Apparatus

Sec. 84.70 Self-contained breathing apparatus; description.

(a) Self-contained breathing apparatus, including all completely

assembled, portable, self-contained devices designed for use as

respiratory protection during entry into and escape from or escape only

from hazardous atmospheres, are described as follows:

(1) Closed-circuit apparatus. An apparatus of the type in which the

exhalation is rebreathed by the wearer after the carbon dioxide has

been effectively removed and a suitable oxygen concentration restored

from sources composed of:

(i) Compressed oxygen; or

(ii) Chemical oxygen; or

(iii) Liquid-oxygen.

(2) Open-circuit apparatus. An apparatus of the following types

from which exhalation is vented to the atmosphere and not rebreathed:

(i) Demand-type apparatus. An apparatus in which the pressure

inside the facepiece in relation to the immediate environment is

positive during exhalation and negative during inhalation; or

(ii) Pressure-demand-type apparatus. An apparatus in which the

pressure inside the facepiece in relation to the immediate environment

is positive during both inhalation and exhalation.

(b) The following respirators may be classified as designed and

approved for use during emergency entry into a hazardous atmosphere:

(1) A combination respirator which includes a self-contained

breathing apparatus; and

(2) A Type ``C'' or Type ``CE'' supplied air respirator, where--

(i) The self-contained breathing apparatus is classified for 3-, 5-

, or 10-minute service time and the air line supply is used during

entry; or

(ii) The self-contained breathing apparatus is classified for 15

minutes or longer service time and not more than 20 percent of the

rated capacity of the air supply is used during entry.

(c) Self-contained breathing apparatus classified for less than 1

hour service time will not be approved for use during underground mine

rescue and recovery operations except as auxiliary equipment.

(d) Self-contained breathing apparatus classified for less than 30

minutes' service time will not be approved for use as auxiliary

equipment during underground mine rescue and recovery operations.

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

(a) Each self-contained breathing apparatus described in Sec. 84.70

shall, where its design requires, contain the following component

parts:

(1) Facepiece or mouthpiece, and noseclip;

(2) Respirable breathing gas container;

(3) Supply of respirable breathing gas;

(4) Gas pressure or liquid level gages;

(5) Timer;

(6) Remaining service life indicator or warning device;

(7) Hand-operated valves;

(8) Breathing bag;

(9) Safety relief valve or safety relief system; and

(10) Harness.

(b) The components of each self-contained breathing apparatus shall

meet the minimum construction requirements set forth in subpart G of

this part.

Sec. 84.72 Breathing tubes; minimum requirements.

Flexible breathing tubes used in conjunction with breathing

apparatus shall be designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces and mouthpieces;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm

pressure.

Sec. 84.73 Harnesses; installation and construction; minimum

requirements.

(a) Each apparatus shall, where necessary, be equipped with a

suitable harness designed and constructed to hold the components of the

apparatus in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy

removal and replacement of apparatus parts and, where applicable,

provide for holding a full facepiece in the ready position when not in

use.

Sec. 84.74 Apparatus containers; minimum requirements.

(a) Apparatus may be equipped with a substantial, durable container

bearing markings which show the applicant's name, the type and

commercial designation of the respirator it contains, and all

appropriate approval labels.

(b) Containers supplied by the applicant for carrying or storing

self-contained breathing apparatus will be inspected, examined, and

tested as components of the respirator for which approval is sought.

(c) Containers for self-contained breathing apparatus shall be

designed and constructed to permit easy removal of the apparatus.

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

minimum requirements.

(a) Half-mask facepieces and full facepieces shall be designed and

constructed to fit persons with various facial shapes and sizes,

either:

(1) By providing more than one facepiece size; or

(2) By providing one facepiece size which will fit varying facial

shapes and sizes.

(b) Full facepieces shall provide for the optional use of

corrective spectacles or lenses which shall not reduce the respiratory

protective qualities of the apparatus.

(c) Apparatus with mouthpieces shall be equipped with noseclips

which are securely attached to the mouthpiece or apparatus and provide

an airtight seal.

(d) Facepieces shall be designed to prevent eyepiece, spectacle,

and lens fogging.

Sec. 84.76 Facepieces; eyepieces; minimum requirements.

(a) Facepieces shall be designed and constructed to provide

adequate vision which is not distorted by the eyepiece.

(b) All eyepieces shall be designed and constructed to meet the

impact and penetration requirements specified in Federal Specification,

Mask, Air Line, and Respirator, Air Filtering, Industrial, GGG-M-125d,

October 11, 1965. This Federal Specification is available from the

Government Printing Office or the General Services Administration.

Sec. 84.77 Inhalation and exhalation valves; minimum requirements.

(a) Inhalation and exhalation valves shall be provided where

necessary and protected against damage and distortion.

(b) Exhalation valves shall be:

(1) Protected against external influence; and

(2) Designed and constructed to prevent inward leakage of

contaminated air.

Sec. 84.78 Head harnesses; minimum requirements.

(a) Facepieces shall be equipped with adjustable and replaceable

head harnesses designed and constructed to provide adequate tension

during suspension and an even distribution of pressure over the entire

area in contact with the face.

(b) Mouthpieces shall be equipped, where applicable, with

adjustable and replaceable harnesses designed and constructed to hold

the mouthpiece in place.

Sec. 84.79 Breathing gas; minimum requirements.

(a) Breathing gas used to supply apparatus shall be respirable and

contain no less than 19.5 (dry atmosphere) volume percent of oxygen.

(b) Oxygen, including liquid oxygen, shall meet the minimum

requirements for medical or breathing oxygen set forth in the U.S.

Pharmacopeia.

(c) Compressed, gaseous breathing air shall meet the applicable

minimum grade requirements for Type I gaseous air set forth in the

Compressed Gas Association Commodity Specification for Air, G-7.1

(Grade D or higher quality).

(d) Compressed, liquefied breathing air shall meet the applicable

minimum grade requirements for Type II liquid air set forth in the

Compressed Gas Association Commodity Specification for Air, G-7.1

(Grade B or higher quality).

Sec. 84.80 Interchangeability of oxygen and air prohibited.

Approvals shall not be issued by the Institute for any apparatus,

combination of respirator assemblies, or any apparatus or respirator

component which is designed or constructed to permit the

interchangeable use of oxygen and air.

Sec. 84.81 Compressed breathing gas and liquefied breathing gas

containers; minimum requirements.

(a) Compressed breathing gas and liquefied breathing gas containers

shall meet the minimum requirements of the Department of Transportation

for interstate shipment of such containers when fully charged.

(b) Such containers shall be permanently and legibly marked to

identify their contents, e.g., compressed breathing air, compressed

breathing oxygen, liquefied breathing air, or liquefied breathing

oxygen.

(c) Containers normally removed from apparatus for refilling shall

be equipped with a dial indicating gage which shows the pressure in the

container.

(d) Compressed breathing gas contained valves or a separate

charging system or adapter provided with each apparatus shall be

equipped with outlet threads specified for the service by the American

National Standard for Compressed Gas Cylinder Valve Outlet and Inlet

Connections, B57.1 (1965), obtainable from American National Standards

Institute, Inc., 1430 Broadway, New York, NY 10018.

Sec. 84.82 Gas pressure gages; minimum requirements.

(a) Gas pressure gages employed on compressed breathing gas

containers shall be calibrated in pounds per square inch.

(b) Liquid-level gages shall be calibrated in fractions of total

container capacity, or in units of liquid volume.

(c) Gas pressure gages other than those specified in paragraphs (a)

and (b) of this section shall be calibrated in:

(1) Pounds per square inch; or

(2) In fractions of total container capacity; or

(3) Both in pounds per square inch and fractions of total container

capacity.

(d)(1) Dial-indicating gages shall be reliable to within

5 percent of full scale when tested both up and down the

scale at each of 5 equal intervals.

(2) The full-scale graduation of dial-indicating gages shall not

exceed 150 percent of the maximum rated cylinder pressures specified

for the container in applicable Department of Transportation

specifications or permits.

(e)(1) Stem-type gages shall be readable by sight and by touch and

shall have a stem travel distance of not less than one-fourth inch

between each graduation.

(2) A minimum of five graduations shall be engraved on the stem of

each gage and these graduations shall include readings for empty, one-

quarter, one-half, three-quarters, and full.

(3) Stem gage readings shall not vary from true readings by more

than one-sixteenth inch per inch of stem travel.

(f) The loss of gas through a broken gage or severed gage

connection shall not exceed 70 liters per minute when the cylinder

pressure is 6,900 kN/m.\2\ (1,000 pounds per square inch gage) or when

the liquid level is at one-half.

(g) Where gages are connected to the apparatus through a gage line,

the gage and line shall be capable of being isolated from the apparatus

except where the failure of the gage or line would not impair the

performance or service life of the apparatus.

(h) Oxygen pressure gages shall have the words ``Oxygen'' and ``Use

No Oil'' marked prominently on the gage.

(i)(1) Apparatus using compressed breathing gas, except apparatus

classified for escape only, shall be equipped with gages visible to the

wearer which indicate the remaining gas content in the container.

(2) Apparatus using liquefied breathing gas, except apparatus

classified for escape only, shall be equipped with gages visible to the

wearer which indicate the remaining liquid content in the container;

however, where the liquid content cannot be rapidly vented, and the

service time of the device begins immediately after filling, a timer

shall be provided in place of a visible gage.

Sec. 84.83 Timers; elapsed time indicators; remaining service life

indicators; minimum requirements.

(a) Elapsed time indicators shall be provided for apparatus with a

chemical oxygen source, except:

(1) Apparatus used for escape only; or

(2) Liquefied breathing gas apparatus equipped with gages visible

to the wearer which indicate the remaining liquid content in the

container.

(b) The timer or other indicator shall be accurately calibrated in

minutes of remaining service life.

(c) Timers shall be readable by sight and by touch during use by

the wearer.

(d) Timers shall be equipped with automatically preset alarms which

will warn the wearer for a period of 7 seconds or more after the preset

time has elapsed.

(e) Remaining service-life indicators or warning devices shall be

provided in addition to a pressure gage on compressed gas self-

contained breathing apparatus, except apparatus used for escape only,

and shall operate automatically without preadjustment by the wearer.

(f) Each remaining service-life indicator or warning device shall

give an alarm when the remaining service life of the apparatus is

reduced within a range of 20 to 25 percent of its rated service time.

Sec. 84.84 Hand-operated valves; minimum requirements.

(a) Hand-operated valves shall be designed and constructed to

prevent removal of the stem from the valve body during normal usage to

insure against a sudden release of the full pressure of the container

when the valve is opened.

(b) Valves shall be designed or positioned to prevent accidental

opening and closing, and damage from external forces.

(c) Valves operated during use of the apparatus shall be installed

in locations where they can be readily adjusted by the wearer.

(d) Main-line valves, designed and constructed to conserve gas in

the event of a regulator or demand valve failure, shall be provided in

addition to gas container valves, except when such failure will not

affect performance.

(e) Hand-operated bypass systems designed and constructed to permit

the wearer to breathe and to conserve his gas supply in the event of a

regulator or demand valve failure, shall be provided where necessary.

(f) Valves installed on apparatus shall be clearly distinguishable

from one another by sight and touch.

(g) The bypass system valve control shall be colored red.

(h) A main-line or bypass valve or system will not be required on

apparatus for escape only.

(i) Safety relief valves or systems, designed and constructed to

release excess pressure in the breathing circuit, shall be provided on

closed-circuit apparatus, and shall meet the following requirements:

(1) The relief valve or system shall operate automatically when the

pressure in the breathing circuit on the inhalation side of the

breathing bag reaches 13 mm. (one-half inch) water-column height of

pressure above the minimum pressure required to fill the breathing bag,

within the breathing resistance requirements for the apparatus.

(2) The relief valve or system shall be designed to prevent

external atmospheres from entering the breathing circuit.

(3) The relief valve or system shall be designed to permit manual

overriding for test purposes and in the event of a failure in the valve

or system.

Sec. 84.85 Breathing bags; minimum requirements.

(a) Breathing bags shall have sufficient volume to prevent gas

waste during exhalation and to provide an adequate reserve for

inhalation.

(b) Breathing bags shall be constructed of materials which are

flexible and resistant to gasoline vapors.

(c) Breathing bags shall be installed in a location which will

protect them from damage or collapse by external forces, except on

apparatus classified for escape only.

Sec. 84.86 Component parts exposed to oxygen pressures; minimum

requirements.

Each applicant shall certify that the materials employed in the

construction of component parts exposed to oxygen pressures above

atmospheric pressure are safe and compatible for their intended use.

Sec. 84.87 Compressed gas filters; minimum requirements.

All self-contained breathing apparatus using compressed gas shall

have a filter downstream of the gas source to effectively remove

particles from the gas stream.

Sec. 84.88 Breathing bag test.

(a) Breathing bags will be tested in an air atmosphere saturated

with gasoline vapor at room temperature (24-30 deg.C./75-85 deg.F.)

for a continuous period of twice the rated time of the apparatus

(except for apparatus for escape only where the test period shall be

the rated time of the apparatus).

(b) The bag will be operated during this test by a breathing

machine with 24 respirations per minute and a minute-volume of 40

liters.

(c) A breathing machine cam with a work rate of 622 kg.-m./min.

will be used.\1\

---------------------------------------------------------------------------

\1\Silverman, L., G. Lee, T. Plotkin, L. Amory, and A. R.

Yancey, Fundamental Factors in Design of Protective Equipment,

O.S.R.D. Report No. 5732, issued Apr. 1, 1945. The dimensions of the

breathing machine cam are available from the Institute upon request.

---------------------------------------------------------------------------

(d) The air within the bag(s) shall not contain more than 100 parts

per million of gasoline vapor at the end of the test.

Sec. 84.89 Weight requirement.

(a) The completely assembled and fully charged apparatus shall not

weigh more than 16 kg. (35 pounds); however, where the weight decreases

by more than 25 percent of its initial charge weight during its rated

service life, the maximum allowable weight of a completely assembled

and fully charged apparatus shall be 18 kg. (40 pounds).

(b) Where an apparatus employs equipment which contributes

materially to the wearer's comfort, e.g., a cooling system, the

completely assembled and fully charged apparatus shall not weigh more

than 18 kg. (40 pounds) regardless of the decrease in weight during

use.

Sec. 84.90 Breathing resistance test; inhalation.

(a) Resistance to inhalation airflow will be measured in the

facepiece or mouthpiece while the apparatus is operated by a breathing

machine as described in Sec. 84.88.

(b) The inhalation resistance of open-circuit apparatus shall not

exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120

liters per minute).

(c) The inhalation resistance of closed-circuit apparatus shall not

exceed the difference between exhalation resistance (Sec. 84.91(e)) and

10 cm. (4 inches) water-column height.

Sec. 84.91 Breathing resistance test; exhalation.

(a) Resistance to exhalation airflow will be measured in the

facepiece or mouthpiece of open-circuit apparatus with air flowing at a

continuous rate of 85 liters per minute.

(b) The exhalation resistance of demand apparatus shall not exceed

25 mm. (1 inch) water-column height.

(c) The exhalation resistance of pressure-demand apparatus shall

not exceed the static pressure in the facepiece by more than 51 mm. (2

inches) water-column height.

(d) The static pressure (at zero flow) in the facepiece shall not

exceed 38 mm. (1.5 inches) water-column height.

(e) Resistance to exhalation airflow will be measured in the

facepiece or mouthpiece of closed-circuit apparatus with a breathing

machine as described in Sec. 84.88, and the exhalation resistance shall

not exceed 51 mm. (2 inches) water-column height.

Sec. 84.92 Exhalation valve leakage test.

(a) Dry exhalation valves and valve seats will be subjected to a

suction of 25 mm. (1 inch) water-column height while in a normal

operating position.

(b) Leakage between the valve and the valve seat shall not exceed

30 milliliters per minute.

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

(a) A static-flow test will be performed on all open-circuit

apparatus.

(b) The flow from the apparatus shall be greater than 200 liters

per minute when the pressure in the facepiece of demand-apparatus is

lowered by 51 mm. (2 inches) water-column height when full container

pressure is applied.

(c) Where pressure demand apparatus are tested, the flow will be

measured at zero gage pressure in the facepiece.

(d) Where apparatus with compressed-breathing-gas containers are

tested, the flow test shall also be made with 3,450 kN/m.2 (500

p.s.i.g.) container pressure applied.

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

(a) Where oxygen is supplied by a constant-flow device only, the

rate of flow shall be at least 3 liters per minute for the entire rated

service time of the apparatus.

(b) Where constant flow is used in conjunction with demand flow,

the constant flow shall be greater than 1.5 liters per minute for the

entire rated service time.

(c) All demand-flow devices shall provide at least 30 liters of

oxygen per minute when in the fully open position.

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

(a) Service time will be measured with a breathing machine as

described in Sec. 84.88.

(b) The open-circuit apparatus will be classified according to the

length of time it supplies air or oxygen to the breathing machine.

(c) The service time obtained on this test will be used to classify

the open-circuit apparatus in accordance with Sec. 84.53.

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

(a) The closed-circuit apparatus will be classified according to

the length of time it supplies adequate breathing gas to the wearer

during man test No. 4 described in Table 4 of this subpart.

(b) The service time obtained on man test No. 4 will be used to

classify the closed-circuit apparatus in accordance with Sec. 84.53.

Sec. 84.97 Test for carbon dioxide in inspired gas; open- and closed-

circuit apparatus; maximum allowable limits.

(a) Open-circuit apparatus:

(1) The concentration of carbon dioxide in inspired gas in open-

circuit apparatus will be measured at the mouth while the apparatus

mounted on a dummy head is operated by a breathing machine.2

---------------------------------------------------------------------------

\2\Kloos, E. J., and J. Lamonica, A Machine-Test Method for

Measuring Carbon Dioxide in the Inspired Air of Self-Contained

Breathing Apparatus. Bureau of Mines Report of Investigations 6865,

1966, 11 pp.

---------------------------------------------------------------------------

(2) The breathing rate will be 14.5 respirations per minute with a

minute-volume of 10.5 liters.

(3) A sedentary breathing machine cam will be used.

(4) The apparatus will be tested at a temperature of 27

2 deg. C. (80 5 deg. F.).

(5) A concentration of 5 percent carbon dioxide in air will be

exhaled into the facepiece.

(b) Closed-circuit apparatus. The concentration of carbon dioxide

in inspired gas in closed-circuit apparatus will be measured at the

mouth while the parts of the apparatus contributing to dead-air space

are mounted on a dummy head and operated by the breathing machine as in

paragraphs (a)(1) through (5) of this section.

(c) During the testing required by paragraphs (a) and (b) of this

section, the concentration of carbon dioxide in inspired gas at the

mouth will be continuously recorded, and the maximum average

concentration during the inhalation portion of the breathing cycle

shall not exceed the following limits:

------------------------------------------------------------------------

Maximum allowable

average concentration

Where the service time is of carbon dioxide in

inspired air percent by

volume

------------------------------------------------------------------------

Not more than 30 minutes....................... 2.5

1 hour......................................... 2.0

2 hours........................................ 1.5

3 hours........................................ 1.0

4 hours........................................ 1.0

------------------------------------------------------------------------

(d) In addition to the test requirements for closed-circuit

apparatus set forth in paragraph (b) of this section, gas samples will

be taken during the course of the man tests described in Tables 1, 2,

3, and 4 of this subpart. These gas samples will be taken from the

closed-circuit apparatus at a point downstream of the carbon dioxide

sorbent, and they shall not contain more than 0.5 percent carbon

dioxide at any time, except on apparatus for escape only, using a

mouthpiece only, the sample shall not contain more than 1.5 percent

carbon dioxide at any time.

Sec. 84.98 Tests during low temperature operation.

(a) The applicant shall specify the minimum temperature for safe

operation and two persons will perform the tests described in

paragraphs (c) and (d) of this section, wearing the apparatus according

to applicant's directions. At the specified temperature, the apparatus

shall meet all the requirements described in paragraph (e) of this

section.

(b) The apparatus will be precooled at the specified minimum

temperature for 4 hours.

(c) The apparatus will be worn in the low temperature chamber for

30 minutes, or for the service time of the apparatus, whichever is

less.

(d) During the test period, alternate 1-minute periods of exercise

and rest will be required with the exercise periods consisting of

stepping onto and off a box 21.5 cm. (8\1/2\ inches) high at a rate of

30 cycles per minute.

(e)(1) The apparatus shall function satisfactorily at the specified

minimum temperature on duplicate tests.

(2) The wearer shall have sufficient unobscured vision to perform

the work.

(3) The wearer shall not experience undue discomfort because of

airflow restriction or other physical or chemical changes in the

operation of the apparatus.

(f) Auxiliary low-temperature parts which are commercially

available to the user may be used on the apparatus to meet the

requirements described in paragraph (e) of this section.

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

(a) The man tests described in Tables 1, 2, 3, and 4 of this

subpart represent the workload performed in the mining, mineral, or

allied industries by a person wearing the apparatus tested.

(b) The apparatus tested will be worn by Institute personnel

trained in the use of self-contained breathing apparatus, and the

wearer will, before participating in these tests, pass a physical

examination conducted by a qualified physician.

(c) All man tests will be conducted by the Institute.

(d) The apparatus will be examined before each man test to ensure

that it is in proper working order.

(e) Breathing resistance will be measured within the facepiece or

mouthpiece and the wearer's pulse and respiration rate will be recorded

during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.

(f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.

(g) If man tests are not completed through no fault of the

apparatus, the test will be repeated.

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

Man tests 1, 2, 3, and 4, set forth in Tables 1, 2, 3, and 4 of

this subpart, respectively, prescribe the duration and sequence of

specific activities. These tests will be conducted to:

(a) Familiarize the wearer with the apparatus during use;

(b) Provide for a gradual increase in activity;

(c) Evaluate the apparatus under different types of work and

physical orientation; and

(d) Provide information on the operating and breathing

characteristics of the apparatus during actual use.

Sec. 84.101 Man test 5; requirements.

(a) Test 5 will be conducted to determine the maximum length of

time the apparatus will supply the respiratory needs of the wearer

while he is sitting at rest.

(b) The wearer will manipulate the devices controlling the supply

of breathing gas to the advantage of the apparatus.

(c) Samples of inspiration from within the apparatus facepiece or

mouthpiece shall be taken once every 15 minutes, and shall meet the

minimum requirement for oxygen specified in Sec. 84.79(a), and the

maximum allowable average concentration of carbon dioxide specified in

Sec. 84.97(c).

(d) One sample of inspiration will be taken in the case of 3-, 5-,

and 10-minute apparatus.

Sec. 84.102 Man test 6; requirements.

(a) Man test 6 will be conducted with respect to liquefied

breathing gas apparatus only.

(b) This test will be conducted to evaluate operation of the

apparatus in other than vertical positions.

(c) The wearer will lie face downward for one-fourth the service

life of the apparatus with a full charge of liquefied breathing gas,

and then a one-quarter full charge of liquefied breathing gas.

(d) The test will be repeated with the wearer lying on each side

and on his back.

(e) The oxygen content of the gas supplied to the wearer by the

apparatus will be continuously measured.

Sec. 84.103 Man tests; performance requirements.

(a) The apparatus shall satisfy the respiratory requirements of the

wearer for the classified service time.

(b) Fogging of the eyepiece shall not obscure the wearer's vision,

and the wearer shall not experience undue discomfort because of fit or

other characteristics of the apparatus.

(c) When the ambient temperature during testing is 246

deg.C. (7510 deg.F.), the maximum temperature of inspired

air recorded during man tests shall not exceed the following, after

correction for deviation from 24 deg.C. (75 deg.F.):

----------------------------------------------------------------------------------------------------------------

Maximum permissible temperature of inspired air

Where percent relative shall not exceed--

Where service life of apparatus is-- humidity of inspired -------------------------------------------------

air is-- deg.F. deg.C.

----------------------------------------------------------------------------------------------------------------

\1/4\ hour or less................... 0-100 135 57

\1/2\ hour to \3/4\ hour............. 0-50 125 52

50-100 \1\110 \1\43

1 to 2 hours......................... 0-50 115 46

50-100 \1\105 \1\41

3 hours.............................. 0-50 110 43

50-100 \1\100 \1\38

4 hours.............................. 0-50 105 41

50-100 \1\95 \1\35

----------------------------------------------------------------------------------------------------------------

\1\Where percent relative humidity is 50-100 and apparatus is designed for escape only, these maximum

permissible temperatures will be increased by 5 deg.C. (10 deg.F.).

Sec. 84.104 Gas tightness test; minimum requirements.

(a) Each apparatus will be tested for tightness by persons wearing

it in an atmosphere of 1,000 p.p.m. isoamyl acetate.

(b) Six persons will each wear the apparatus in the test

concentrations specified in paragraph (a) of this section for 2 minutes

and none shall detect the odor or taste of the test vapor.

Tables to Subpart H of Part 84

Table 1.--Duration and Sequence of Specific Activities for Test 1, in Minutes

[42 CFR part 84, subpart H]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Service time--

---------------------------------------------------------------------------------------------------------------------------------------

Activity 2, 3, and 4

3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour hours

--------------------------------------------------------------------------------------------------------------------------------------------------------

Sampling and ............... ............... ............... 2.............. 2.............. 2.............. 2.............. Perform 1 hour

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