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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

42 CFR Part 84

RIN 0905–AB58

Respiratory Protective Devices

AGENCY: National Institute for

Occupational Safety and Health

(NIOSH), Centers for Disease Control

and Prevention, Public Health Service,

HHS.

ACTION: Final rule.

SUMMARY: This final rule addresses

NIOSH and the Department of Labor/

Mine Safety and Health Administration

(MSHA) certification requirements for

respiratory protective devices.

Specifically, the rule replaces MSHA

regulations with new public health

regulations, while also upgrading testing

requirements for particulate filters.

This action is the first of a series of

modules that will incrementally

upgrade current respirator approval

requirements. This modular approach

will allow improvements to be

implemented on a safety and health

priority basis as well as facilitate

adaptation to new requirements by the

manufacturers and users of respirators.

It will also expedite the incorporation of

technological advancements and will

allow for the expeditious response to

emerging hazards.

Except for the particulate-filter

requirements, most requirements of the

existing regulations are incorporated

into the new regulations without

change. The revised testing

requirements for particulate filters

significantly improve the effectiveness

of evaluating air-purifying filters to

remove toxic particulates from the

ambient air. These requirements are

consistent with two decades of advances

in respiratory protection technology.

The certification of air-purifying

respirators under the final rule will also

enable respirator users to select from a

broader range of certified respirators

that meet the performance criteria

recommended by CDC for respiratory

devices used in health-care settings for

protection against Mycobacterium

tuberculosis (Mtb), the infectious agent

that causes tuberculosis (TB).

Elsewhere in this separate part of the

Federal Register, MSHA is publishing a

final rule to remove existing regulations

which are made obsolete by this final

rule.

EFFECTIVE DATES: This final rule is

effective on July 10, 1995. The

incorporation by reference of certain

publications used in the regulations is

approved by the Director of the Federal

Register as of July 10, 1995.

FOR FURTHER INFORMATION CONTACT:

Richard W. Metzler, NIOSH, 1095

Willowdale Road, Morgantown, West

Virginia 26505–2888. The telephone

number is (304) 285–5907.

SUPPLEMENTARY INFORMATION:

I. Availability of Copies and Access to

Final Rule

Additional copies of this final rule

can be obtained by calling the NIOSH

toll-free information number (1–800–

35–NIOSH, option 5, 9:00 AM–4:00 PM

ET). Arrangements have also been made

for this final rule to be listed on the

electronic bulletin boards of the

Government Printing Office and of the

Department of Labor; the telephone

numbers are (202) 512–1387 and (202)

219–4784, respectively. This final rule

may also be obtained from the NIOSH

Home Page on the World-Wide Web.

The location for the NIOSH Home Page

is http://www.cdc.gov/niosh/

homepage.html.

II. Paperwork Reduction Act

This final rule contains information

collections that have been approved by

the Office of Management and Budget

under the Paperwork Reduction Act of

1980 and assigned control Number

0920–0109. The title, description, and

respondent description of the

information collection are shown below

with an estimate of the annual reporting

and recordkeeping burden. Included in

the estimate is the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Title: Respiratory Protective Devices.

Description: This rule prescribes

requirements and procedures which

must be met in filing applications for

approval by NIOSH of respirators and

modifications of respirators.

Description of Respondents:

Businesses and other for-profits.

Estimated Annual Reporting and

Recordkeeping Burden:

Section

Annual

number of

respondents

Annual frequencyAverage burden

per response

Annual burden hours

84.35 ....................................................................................................................... 56 10.5 79.45 hr ............ 46,716 hr.

84.41 ....................................................................................................................... 56 10.5 22.70 hr ............ 13,347 hr.

84.43 ....................................................................................................................... 56 10.5 56.75 hr ............ 33,369 hr.

Total ............................................................................................................. ................... ................... ........................... 130,805 hr.

The above citations are currently

cleared under 30 CFR Part 11 as OMB

control Number 0920–0109.

A Paperwork Reduction package is

being submitted to OMB, requesting

approval of the requirement for labeling

to be effected by § 84.33. A document

will be published in the Federal

Register when such approval has been

obtained.

III. Background

NIOSH published a proposed rule (59

FR 26850) to establish a new 42 CFR

part 84, on May 24, 1994. On May 26,

1994, NIOSH published a notice in the

Federal Register (59 FR 27257) for an

extension of the public comment period

and a rescheduling of a public meeting.

A public meeting was held to obtain

comments on the proposal in

Washington, D.C. on June 23–24, 1994.

The proposal and public meeting

received response from the full

complement of affected parties in the

public. Commenters included safety

professionals, respirator manufacturers,

representatives of industrial and healthcare facilities, and workers’

associations. Three hundred and three

commenters responded to the proposed

rule. One hundred twenty six

commenters represented health-care

workers. Ninety six commenters

represented health-care facilities.

Fifteen commenters represented

associations of health-care

professionals. Fifteen commenters

represented associations of health-care

facilities. Seventeen commenters

represented respirator manufacturers.

Eight commenters represented trade or

manufacturers’ associations. Eight

individuals commented as private

citizens. Six commenters represented

regulatory agencies (federal, state,
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30337

county). Five commenters represented

respiratory protection experts. Three

commenters represented workers’

organizations. Two commenters

represented test instrument

manufacturers. One commenter

represented industrial hygiene

professionals. One commenter

represented a Federal Advisory

Committee. These figures include the 18

presenters at the Public Meeting held in

Washington, D.C. on June 23 and 24,

1994.

IV. Summary of Major Changes in

Response to Comments

The requirements of the final rule

differ from those proposed (59 FR

26850) in 8 major areas. These changes,

discussed in sections V. Administrative

and Procedural Matters of Final Rule

and VI. Discussion of Final Rule, are

summarized as follows:

1. Three categories (series) of

particulate filters (N-, R-, and P-series)

are included rather than two (solid and

liquid and solid);

2. Maximum allowable inhalation and

exhalation airflow resistance values

have been slightly increased and

labelling changes are included to

identify the certified efficiency level to

users;

3. The new certification categories

apply only to non-powered air-purifying

respirators. Powered air-purifying

particulate respirators (PAPRs) will be

approved only with filters meeting the

requirements for 30 CFR part 11 highefficiency filters;

4. A new subpart KK has been added

for the issuance of extensions of existing

30 CFR part 11 approvals to address

respirator non-conformances when there

is a demonstrated safety or health need

during the transition period and for the

approval of PAPRs;

5. Fit testing during the certification

process is not included for particulate

respirators;

6. The number of tested units has

been reduced and the test data will no

longer be treated statistically;

7. The period for sale and shipment

of 30 CFR part 11 certified particulate

respirators has been increased. The

period for processing part 11

applications has been eliminated,

except for demonstrated need; and

8. Testing parameters are stated more

explicitly.

A summary listing of the section-bysection changes from the proposal to

this final rule is provided in Appendix

A—Comparison of Technical

Requirements Final Rule to Proposed

Rule. Each of these changes is discussed

in detail in the following preamble.

V. Administrative and Procedural

Matters of Final Rule

A. Modular Approach

The proposed rule explained the

intent to promulgate modifications to

the requirements of 30 CFR part 11 in

a series of modules. There are numerous

benefits to utilizing a modular approach

to promulgate changes to the existing

requirements. Among these are the

following considerations:

1. Improvements can be implemented

on a priority basis, assuring that those

expected to contribute most to

improving worker protection are

implemented first;

2. Incremental promulgation of

improvements should facilitate

adaptation to new requirements by the

respirator manufacturer and user

communities, minimizing the potential

for any disruption in the supply of

certified respirators;

3. Public participation in the

rulemaking process will be facilitated by

proposing important regulatory changes

in individual segments of separate

rulemaking; and

4. Improvements made to limited

segments of the rule can be

implemented in a much shorter time

period than comprehensive revisions to

the entire rule. Therefore

implementation of technological

advancements and response to emerging

hazards will be expedited.

Comments overwhelmingly endorsed

the concept of the modular approach

with only two comments specifically

opposed to this approach. More than

250 comments supported the proposal’s

approach and approximately 40

specifically endorsed and offered

recommendations for changes in the

modular scheduling. Some commenters

expressed concerns about this new

rulemaking procedure. These

predominantly questioned the

interaction of modules and

implementation schedules. Module

interaction concerns included added

costs, confusion, transition periods

(grandfathering) of interrelated modules,

and redesign of respirators due to effects

of multiple modules. Concerns of

scheduling included the priority of

modules, additional module topics,

transition periods for products to meet

prior requirements, timetable for

completion of revisions, and availability

of NIOSH resources to support work on

multiple modules simultaneously.

The modular approach represents a

continuous improvement strategy for

rulemaking. With this process, NIOSH

expects regulations and products to be

incrementally improved and updated to

address worker health concerns and

prevent any disruption in the supply of

respirators. Each module will constitute

a separate rulemaking activity. The

modular approach undertaken by

NIOSH provides clear advantages over

the comprehensive approach to

rulemaking. No specific time period has

been identified in which all certification

standards will be revised. The Institute

recognizes that a predetermined

revision cycle could ensure the periodic

re-examination of standards. However, a

requirement of this type would also

diminish the capability of the Institute,

with its limited resources, to address

priority respiratory protection needs.

The Institute has determined that a

flexible approach is required that will

permit expeditious responses to

emerging respiratory protection

priorities. These can change rapidly as

technological advancements,

international harmonization, changed

working conditions, or the emergence of

new hazards make current standards

obsolete. As discussed below the

Institute will balance industry’s need for

planning and adjustment time

associated with future modules by

having ample public involvement in

setting the priorities for module

selection and with judicious selection of

transition periods.

NIOSH is aware of the needs of the

respirator community to be able to plan

future production and purchasing

needs. This is true for consumers as

well as manufacturers of respirators.

NIOSH announced at the informal

public meeting its intention to hold

ample public meetings in advance of

any proposed future modules so that

these concerns could be addressed. The

concerns expressed in the comments

can be addressed in these informal

public meetings and with the use of

appropriate transition periods.

NIOSH intends to establish transition

periods for implementing the

requirements of each module. These

transition periods will be determined by

an assessment of the industry’s ability to

adopt the new requirements, ongoing

transition periods from prior modules,

and the public health implications of

the changes.

Anticipated subjects and sequence of

the NIOSH rulemaking were outlined in

the proposed rule. Numerous comments

were received providing suggestions for

additional module subjects and their

priority. Suggested additional subjects

included powered air-purifying

respirators, smoke masks, fit testing,

supplied air respirators, gas masks, and

combination respirators. Suggestions on

scheduling priorities indicated a

diversity in perceived needs. Based on

the public interest in the future module
30338 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

subject areas and timetable, NIOSH will

conduct a public meeting to further

develop the schedule with input from

all interested parties. The location and

date for this meeting will be announced

in the Federal Register, Morbidity and

Mortality Weekly Report (MMWR), and

other media.

The Institute coordinated the

development and implementation of the

modular approach with OSHA and

MSHA. The specific requirements of

this first module were reviewed and

accepted by both agencies to ensure that

42 CFR part 84 properly links with

OSHA and MSHA respirator use

regulations. Both agencies will

participate in the development by

NIOSH of appropriate user guidelines.

NIOSH and MSHA developed a

Memorandum of Understanding to

delineate roles for the continuing joint

approval under 42 CFR part 84 of

respirators used for mine emergencies

and mine rescue. The Institute will

continue to collobrate with MSHA and

OSHA as future modules are developed.

B. User’s Guide

The proposal stated the intent to

develop a user’s notice or guide to

explain the use of respirators certified

for protection against particulate

exposures under the new 42 CFR part 84

that would replace the existing filter

respirators certified under 30 CFR part

11 subparts K and M. Commenters

indicated that this user’s guide should

be developed in a public forum with

public involvement. One commenter

stated that the user’s guide should be

issued prior to the finalization of part

84. Another believed that its availability

should coincide with the publication of

the final rule. Constraints on releasing

specific information as to the contents

of the final rule prior to its publication

limits the availability of information

needed for development of a user’s

guide, thus making its development

with public input prior to or concurrent

with this rule impossible. NIOSH agrees

with the commenters that public input

into the user’s guide will result in a

better product. An informational

respirator user’s guide for part 84

respirators will be developed with

public involvement.

The user’s guide will address both the

use of part 11 and part 84 respirators

during the transition period. Assigned

Protection Factor (APF) values are used

in the respirator selection process to

indicate the expected protection level

for the respirator wearer. NIOSH

recommends APFs for respirators

certified under 30 CFR part 11 in its

Guide to Industrial Respiratory

Protection and in the Respirator

Decision Logic. The future user’s guide

will recommend APFs appropriate for

use with the part 84 particulate

respirators until APFs can be addressed

through future rulemaking. It will also

provide information and

recommendations on a variety of other

respirator use issues associated with

this current rulemaking.

During review of this rule, both OSHA

and MSHA expressed strong interest in

the APF values for the new part 84

particulate filter classifications. Both

agencies agreed with NIOSH that APFs

could not be addressed properly in this

first module. They therefore urged

NIOSH to develop a subsequent module

defining APFs for all respirators. In the

interim, OSHA regulations under Title

29 and the MSHA regulations under

Title 30 will allow the use of the new

part 84 particulate classifications with

the APFs to be established by NIOSH in

the users’ guide. OSHA is in the process

of updating its respirator use

regulations, and the current proposal

specifies acceptance of APFs developed

and promulgated under part 84.

C. Use of Particulate Respirators for

Protection Against TB

While the requirements in this final

rule were not developed specifically to

certify respirators against biological

agents, this rule will address the

important public health need to control

the transmission of Mycobacterium

tuberculosis, the causative agent of TB,

in health-care and other facilities

through the use of respiratory protective

devices.

In response to the recognized risk of

TB transmission in health-care facilities,

increases in TB in many areas, and

recent outbreaks of multidrug-resistant

TB, CDC published ‘‘Guidelines for

Preventing the Transmission of

Mycobacterium tuberculosis in HealthCare Facilities, 1994’’, in the Federal

Register (59 FR 54242) and MMWR

(Volume 43, No. RR–13) on October 28,

1994. These guidelines enumerate four

performance criteria that CDC has

determined are necessary for respiratory

protective devices used in health-care

settings for protection against TB. The

only currently certified air-purifying

respirator class that meets all the

respiratory protection performance

criteria in the CDC Guidelines is a

respirator with a high efficiency (HEPA)

filter. Many comments were received

from the health-care community

supporting the positive impact of the

proposed rule on compliance with the

CDC Guidelines.

All nine classes of air-purifying,

particulate respirators to be certified

under the provisions of the new

particulate filter tests (filter efficiency)

in part 84 meet or exceed the

performance recommendations

contained in the CDC Guidelines.

Several of these new classes of airpurifying, particulate respirators are

expected to be less expensive than

respirators with HEPA filters.

Consequently, implementation of the

modifications included in this rule

should promote a substantial increase in

respiratory protection provided to

health-care and other workers

potentially exposed to the M.

tuberculosis droplet nuclei in healthcare and other occupational settings.

D. Conversion From 30 CFR Part 11 to

42 CFR Part 84

Since 1974, the Mine Enforcement

and Safety Administration (MESA),

MSHA, and the Occupational Safety and

Health Administration (OSHA) have

regulated the selection, use, and

maintenance of respirators in the

workplace under their respective

enforcement authorities. NIOSH is not

including the requirements of §§ 11.2

and 11.2–1 with this redesignation to 42

CFR part 84. Sections 11.2(a) and 11.2–

1 refer to respirator use and selection

criteria that since have been superseded

by OSHA and MSHA respirator

regulations.

Section 11.2(b) allows for the

continued manufacture and sale of gas

masks approved under the former U.S.

Bureau of Mines (BOM) Schedule 14F

(dated April 23, 1955). This Schedule

was replaced by the requirements in

Subpart I of 30 CFR part 11 in 1972. Gas

masks approved under Subpart I of 30

CFR part 11 (14G canisters) are widely

available and only a limited number of

types of 14F canisters are marketed.

MSHA experience indicates that few of

the 14F respirators are currently sold or

used. MSHA also indicated that removal

of the provisions in § 11.2(b) would

remove the authority to market these

respirators as approved devices.

NIOSH is not transferring the

requirements of § 11.2(b) to 42 CFR Part

84 since NIOSH does not have the

capability to process applications for

these respirators. The approval records

on these BOM-approved respirators no

longer exist and therefore NIOSH has no

way of monitoring the production of

these respirators to assure that they

continue to meet the approved design.

Thus, NIOSH will not authorize the sale

and shipment of the Schedule 14F

respirators under this part 84.

In addition, the codification of the

redesignated sections into a nonhyphenated numbering system results

in several general heading sections that

contained no substantive requirements
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30339

not being included in this redesignation.

These include §§ 11.85, 11.102, 11.124,

11.140, and 11.162.

NIOSH is making a limited revision to

the existing requirements of 30 CFR part

11 in this first module, requiring

updated particulate filter tests. This

revision eliminates the need for unique

tests for particulate respirators used for

different types of aerosols, such as dust/

mist, dust/fume/mist, paint spray, and

pesticides. The new certification tests

use the most penetrating aerosol size,

0.3μm, and either a non-degrading

particulate, sodium chloride, or a highly

degrading oil, dioctylphthalate.

Consequently, particulate filters

certified under these new procedures

can be used without regard to aerosol

size, taking into consideration only the

degrading or nondegrading nature of

particulates and the APF required by

exposure concentrations. To revise

respirator nomenclature to be consistent

with this fundamental change in

certification philosophy, the words

dust, fume and mist are replaced with

particulate in the final rule.

Existing subpart M of part 11

(§§ 11.170 through 11.183–7) addresses

the requirements for pesticide

respirators. The requirements of subpart

M are not included in this redesignation

to 42 CFR part 84. This rule eliminates

this category and the tests specific to it,

leaving subpart M reserved. All

references to subpart M and pesticides

as a classification for approval are

eliminated. NIOSH will discontinue

issuance of certifications that classify

these respirators as suitable for use

against a specific particulate.

The existing test requirements in

§§ 11.124–21 through 11.124–24 specify

that a test subject wearing the respirator

be exposed to an abrasive blasting

environment in which the blasting agent

is composed of 99+ percent free silica

(SiO2). This requirement is not included

in this redesignation to 42 CFR part 84.

The purpose of this requirement was to

determine the adequacy of protection

provided in such environments. NIOSH

administratively suspended such tests

over 20 years ago because they placed

test subjects at risk of exposure to

fractured crystalline silica. These tests

are not included in this final rule.

Requirements for abrasive blasting and

other atmosphere supplying respirators

as well as fit testing for all respirator

types will be addressed in a future

module. In the interim, NIOSH will

continue the administrative policy of

the past two decades of conducting

quantitative fit testing in lieu of the tests

stipulated in §§ 11.124–21 through

11.124–24.

Two comments recommended the

inclusion of administrative policies to

the rule. One commenter suggested that

§§ 11.124–21 through 11.124–24

(referring to air-line respirators) be

restored or replaced with the current

administrative policy of quantitative fit

testing. Another commenter was

concerned that the NIOSH policy of

allowing a mixed-gas Self Contained

Breathing Apparatus for fire fighting

was not included in the proposed rule.

NIOSH agrees with these commenters

that administrative policies related to

specific changes in a module should be

incorporated. However, the topics of

concern to these commenters addressed

administrative policies in subject areas

that were not proposed to be changed in

this module, therefore, they have not

been incorporated.

NIOSH has not included the test

procedures of §§ 11.124–21 through

11.124–24 due to NIOSH’s concern of

health risks to test subjects during presubmission testing performed by a

manufacturer seeking approval of a

respirator intended for use in an

abrasive blasting environment.

Although no Type AE or BE respirators

have ever been certified, Type AE, BE,

and CE respirators may be certified for

use in an abrasive blasting environment.

These respirators will be tested using

Air-supplied Respirator Section Test

Procedure Number 23 Abrasive-Blast,

Type CE. Copies of this procedure are

available from the Certification and

Quality Assurance Branch, 1095

Willowdale Road, Morgantown, West

Virginia, 26505–2888.

E. MSHA’s Regulatory Role

The final 42 CFR part 84 regulation is

consistent with the current MSHA and

NIOSH respirator approval program,

placing responsibility for certifying

most respirators with NIOSH. MSHA

and NIOSH will continue to jointly

review and approve respirators used for

mine emergencies, mine rescue, and the

associated service-life plans, user’s

manuals, and other documentation.

Among the types of devices for which

this role is particularly important are

self-contained self-rescue devices. The

final rule preserves MSHA’s current role

in the certification of such respirators

whose unique use in mining is an

important part of safeguarding the

health and safety of miners. In addition,

MSHA will continue to test electrical

and electronic components of

respirators for use in potentially

explosive atmospheres in gassy

underground mines and issue a separate

MSHA approval under 30 CFR part 18

for the electrical components of such

respirators.

In implementing the final regulation,

NIOSH and MSHA have developed a

new Memorandum of Understanding

(MOU) that reflects administrative

matters related to respirator approval,

including immediate notification to

MSHA of field complaints and

identified deficiencies concerning

approved respirators. Three commenters

recommended that the public be

allowed to review and comment on the

MSHA/NIOSH Memorandum of

Understanding. It was indicated by an

agency representative that such

comments on the contents of the MOU

would be welcomed. Two of these

commenters were concerned that the

responsibilities and accountability,

specifically MSHA’s involvement in the

certification of mining-specific

respiratory protective devices, be

maintained in the Memorandum of

Understanding. The third commenter

was unsure if the Memorandum of

Understanding would have an effect on

the notice of public rulemaking.

Comments submitted subsequent to the

public meeting reiterated the concerns

stated at the meeting. These comments

were considered in the MOU’s

development and have subsequently

been addressed. Copies of the MOU will

be available from NIOSH and MSHA.

The new Memorandum of

Understanding between MSHA and

NIOSH delineates the interaction

between the agencies in carrying out the

responsibilities and authorities

provided for in the Mine Safety and

Health Act of 1977 (30 USC § 801 et seq)

and this final rule. It defines the method

of implementation of the regulation and

has no effect on its content. The agency

has determined that this MOU is most

appropriately developed between the

two agencies and thus, commenters did

not directly participate in the

development of the MOU. As indicated

above, public comments on the MOU

are welcome.

F. Transition Period

The proposal included provisions for

phasing out part 11 particulate

respirators. Specifically, no applications

were to be accepted after the effective

date of part 84, with a maximum of 6

months for processing in-house

applications. Sale and shipment

(distribution) of part 11 particulate

respirators would have been allowed for

only 2 years from the effective date of

part 84.

Several commenters indicated that

these transition periods were much

shorter than the 5-year phase-out period

proposed by NIOSH in 1987. Some

comments on the proposed schedule

stated that there must be an appropriate
30340 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

time to develop new products, receive

certification, and initiate production of

the new respirators. Commenters were

also concerned the use of the term

distribution implied manufacturer

control of the distributer system and the

resale market. Several commenters

recommended 4 years for NIOSHprocessing of part 11 applications, and

for sale and shipment of part 11

respirators. NIOSH is expanding the

phase-out period from two to three years

to address these concerns.

With the effective date of part 84,

MSHA and NIOSH will no longer accept

applications for new approvals or

extensions of approval of respirators

under part 11 provisions. All

applications received after the effective

date of part 84 will be considered as

applications for a new or extension of

approval under part 84. Valid part 11

applications that were received prior to

the effective data of part 84 will be

processed for approval under part 11

provisions. A subpart KK containing the

part 11 requirements for particulate

respirators has been added to the final

rule to provide continued authority for

NIOSH to issue extensions of approvals

needed to address respirator recall and

retrofit matters that are associated with

health and safety issues for workers.

Respirators listed as certified under the

provisions of 30 CFR part 11, subparts

K or M, may not be sold or shipped by

the approval holder as NIOSH/MSHA

certified respirators effective July 10,

1998. Continued use of distributed

particulate respirators is under the

jurisdiction of OSHA and MSHA and

therefore is not affected by this rule.

Because certifications will not be

revoked for part 11 devices sold and

shipped by the approval holder prior

July 10, 1998, NIOSH anticipates that

OSHA and MSHA would permit

continued use of those part 11

respirators.

This 3 year period was selected to

ensure the timely replacement of the

part 11 respirators that exhibit low

initial efficiency levels while allowing

an ample supply of respirators to remain

available for use. This timeframe will

provide sufficient time for

manufacturers to have respirators

approved and manufactured in

quantities to meet demand.

Manufacturers’ comments to the

proposed rule support this timeframe, as

some manufacturers appear ready to

provide part 84 respirators immediately.

At least one commenter stated, without

reservation, preparedness to submit

applications to meet the new

requirements. Several commenters

requested that NIOSH accept

applications for part 84 respirators upon

publication, rather than the effective

date of part 84. One manufacturer

commented that NIOSH should

anticipate at least 10 applications from

each manufacturer upon part 84

becoming effective. NIOSH also expects

a significant number of presently

certified particulate respirators, in

addition to new designs, to meet the

requirements of this rule. Therefore, a

high initial application rate for approval

of part 84 particulate respirators is

expected.

Some commenters expressed concern

that NIOSH would not be able to

expeditiously process the part 84

applications, thereby delaying

introduction of the new respirators to

the marketplace. Delays in processing

the part 84 applications would prolong

the time needed for transition to these

new respirators. Division of the NIOSH

staff and resources between processing

part 84 applications and pending part

11 applications, along with routine

extensions of existing part 11 particulate

respirator certifications, may initially

slow the certification and availability of

part 84 respirators. However, the

Institute has determined that it cannot

reject without action part 11

applications that were validly prepared

and submitted while the provisions of

part 11 remain in effect. NIOSH

therefore will process all valid part 11

applications that were received by

NIOSH before the effective date of part

84. The authority for the approval

holder to sell and ship particulate

respirators under any part 11

certification issued under these

conditions will expire along with the

other part 11 certifications on July 10,

1998.

The new technical requirements of

part 84 only address air-purifying

respirators. Other classes of respirators,

such as self-contained breathing

apparatus, gas masks, etc., are not

affected by the new filter penetration

test requirements. Therefore, NIOSH

intends to continue issuing new and

extension of approval numbers in the

same format designation (TC number) as

issued under existing part 11 for those

respirator types whose technical

requirements for approval under part 84

have not been modified from existing

part 11. A new approval number series

will be initiated for the products whose

technical requirements have been

upgraded under part 84. By checking

the approval number, respirator users

will be able to quickly and easily

distinguish those products that have

demonstrated the improved

performance requirements of the new

part 84 from those that have

demonstrated compliance with only the

existing part 11 standards that are

transferred to part 84. NIOSH further

intends to issue public notices of the

new approval designations to be used

for products demonstrating performance

to the improved standards.

VI. Discussion of Final Rule

A. Certification Fit Testing

The proposal contained two sections

(§§ 84.181 and 84.182) that would have

retained the existing Part 11 particulate

respirator fit test protocols using

isoamyl acetate. These tests were

proposed to redesignate the existing

§§ 11.140–1 and 11.140–2 with the tests

unchanged to minimize the scope of the

changes proposed in the first module.

The currently required particulate

respirator facepiece fit tests of part 11

use isoamyl acetate, an organic vapor, as

the test agent. Under existing part 11,

such tests are required for high

efficiency (HEPA) and dust, fume, and

mist (DFM) respirators, but not dust/

mist (DM) respirators. Since particulate

filters are not intended to filter organic

vapors, the tested respirators must often

be modified by the addition of an

activated charcoal layer. This added

charcoal layer prevents penetration of

the isoamyl acetate through the filter so

that the respirator-to-face fit can be

evaluated. As a result, the certification

program tests surrogate respirators that

may have fitting characteristics that

differ from the marketed (certified)

respirators.

Numerous and varied comments were

provided on these sections. A number of

commenters suggested that NIOSH

eliminate fit testing as a condition of

certification. Two commenters

recommended that the rule should

require manufacturers to submit test

data showing good fit characteristics in

lieu of NIOSH conducting fit testing.

Other commenters requested that

NIOSH test the respirator-to-face fit, or

otherwise assure that proper fitting

characteristics were provided by every

certified respirator. Several other

commenters requested that fit testing be

made a meaningful test. Several others

suggested that a quantitative protocol

rather than a qualitative fit protocol

should be used. Two commenters stated

support for the fit tests as proposed.

Several of the reasons given for

eliminating fit testing were that fitting

respirators to individuals in the

certification program does not predict

the fit of an individual wearer; fit testing

of individual workers at the worksite is

required by OSHA and that is the

appropriate setting for fit testing; the

isoamyl acetate test has not been

validated; and, the isoamyl acetate test
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30341

has to be performed on modified

respirators.

The comments requesting that fit

testing be made a meaningful test were

based on reasoning similar to those

suggesting elimination of the test. In

lieu of elimination, they suggested that

some inadequacies could be resolved

with modification of the test protocol to

use a particulate aerosol, such as Bitrex,

as the test agent. Changing the test

protocol to test with a particulate would

at least permit the tested respirator

filters to be as certified, thereby

eliminating specially-made surrogates.

Commenters endorsing NIOSH

continuation of fit testing believed that

the present certification process

provides an assurance that the respirator

will properly fit a given worker when

use of the respirator is needed in the

workplace.

The problems associated with testing

the facepiece-fit in a certification

program have been recognized for years.

Efforts have been made to seek more

meaningful test results; nevertheless,

the validity of the test results remain

questionable.

Successful fit testing in the

certification process provides no

assurance that the respirator will

properly fit a given worker when used

in the workplace. The only means

presently available to assess the fit

achieved on the worker is a respiratorto-face fit test conducted on that

individual with the chosen respirator.

Even this test procedure, conducted on

the individual, cannot assure that the

respirator will maintain a proper fit

when use of the respirator is needed in

the workplace. This concern is

compounded when the fit is determined

with a surrogate respirator.

During review of this rule, both OSHA

and MSHA favored inclusion of

respirator fit testing and fit checking

procedures as part of NIOSH respirator

certifications under the new part 84

particulate filter classifications. Both

agencies accepted the determination by

NIOSH that these issues cannot be

properly addressed in this first module.

Both agencies therefore urged NIOSH to

develop a face fit module to include

respirator fit testing and fit checking

procedures for all respirators.

The purpose of face fit testing in the

certification program has been to assure

that respirators have generally good face

fitting characteristics. However, at this

time NIOSH does not have studies that

define the effectiveness of either the

isoamyl acetate or American National

Standards Institute (ANSI)/OSHA

accepted fit tests in predicting actual

workplace protection provided to

workers. NIOSH is presently conducting

research for this purpose. In the interim,

lacking validation and correlation of

testing protocols, workers’ health

concerns are best served through the

application of fit-testing and fitchecking procedures on individual

workers in a quality respirator program.

Therefore, the isoamyl acetate fit tests

proposed in §§ 84.181 and 84.182 are

not included in this final rule. NIOSH

will address issues associated with facefit efficacy in a separate module upon

completion of the necessary research.

B. Powered Air-purifying Particulate

Respirators

The proposed regulation included

filter efficiency requirements for

powered air-purifying respirators

(PAPRs). The solid and liquid and solid

categories were to be tested with sodium

chloride (NaCl) and dioctyl phthalate

(DOP), respectively. The classes to be

certified were the 99.97 and 99%

efficiency levels. The remaining design

and test parameters for PAPRs were

retained from part 11 without change.

Commenters questioned why the

efficiency levels proposed for PAPRs

were not the same as non-powered

respirators. The proposal specified three

efficiency levels for non-powered (95,

99, 99.97) and only two levels for

PAPRs (99 and 99.97). Commenters

indicated many present filter cartridges

are interchangeable between the nonpowered and PAPR units,

recommending corresponding filter

efficiencies between the non-powered

and PAPR units to retain this broader

market for a filter design.

Numerous commenters stated a

concern that the proposed requirements

of subpart K did not adequately address

PAPRs. These commenters indicated

that the respiratory protection provided

by PAPRs is dependent on the respirator

components working together as a

system. The proposed rule, focusing on

filter efficiency, did not address the

system requirements for these

respirators. These commenters reasoned

that the performance of these

complicated respirator systems deserves

special consideration because of unique

problems addressing airflow, filter

efficiency, and fit. These commenters

suggested that the requirements for

powered units be removed from subpart

K, to be addressed in a separate module.

Other commenters addressing PAPR

requirements stated concerns over

sodium chloride (NaCl) filter test

instrumentation capabilities. With the

present state-of-the-art capabilities, the

proposed PAPR loading requirements

are difficult to achieve. This leads to a

number of testing difficulties including

instrumentation availability, time

consuming tests, reproducibility of

results, and system costs. NIOSH agrees

with these concerns and will address

them in the forthcoming module.

Commenters to the proposal also

acknowledged that the resultant part 84

filters would be a significant

improvement over those currently

certified and marketed under part 11.

Two commenters recognized the

concern over the performance of part 11

powered dust, fume, mist respirators.

They indicated that this concern could

be addressed by incorporating only part

11 high-efficiency filter requirements for

PAPRs approved under part 84. NIOSH

agrees and has revised the rule to permit

the continued use of part 11 high

efficiency filters for PAPRs approved

under part 84.

NIOSH also agrees with commenters

that the proposed filter efficiency

requirements alone do not adequately

address the operational parameters of

PAPRs that should be revised. The

sections of subpart K have therefore

been modified to be applicable only to

non-powered air-purifying particulate

respirators. The requirements for the

powered units will be addressed in a

forthcoming module. In the interim,

powered air-purifying particulate

respirators equipped with HEPA filters

will be approved under the provisions

of subpart KK.

C. Filter Classification

The proposal provided for six classes

of filters in a filter classification system

with three filter efficiency levels and

two categories of filter degradation

resistance. The three efficiency levels

(99.97, 99, and 95%) were determined

by testing with the most penetrating

aerosol size until a maximum loading of

200 mg was reached. The two

degradation resistance categories were

established by the choice of either NaCl

or DOP as the test challenge aerosol.

Sodium Chloride is only mildly

degrading to filter media while DOP is

a liquid oil that is highly degrading.

Accordingly, filters tested with the NaCl

aerosol were recognized as not highly

resistant to degradation and only

appropriate for use with solid aerosols

in the workplace. Filters tested with the

liquid DOP oil were recognized as

highly resistant to degradation and

considered appropriate for both liquid

and solid workplace aerosols.

The categories and classes of filters

that would have been certified under

the proposal are summarized below:

Category Class Efficiency

Test

agent

Solid and liquid ..... A 99.97 DOP
30342 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

Category Class Efficiency

Test

agent

Solid ..................... A 99.97 NaCl

Solid and liquid ..... B 99 DOP

Solid ..................... B 99 NaCl

Solid and liquid ..... C 95 DOP

Solid ..................... C 95 NaCl

The behavior of filters to challenge by

each of the two test aerosols depends on

the filter type. Mechanical filters and

electrostatic filters are the two

fundamental types of particulate filters

on the market. Mechanical filters’

efficiencies are determined by

mechanical features such as the

diameter, orientation, and arrangement

of the fibers that comprise the filter.

Electrostatic filters have a static electric

charge on the filter fibers to enhance the

attraction and retention of the

aerosolized particles. The enhanced

efficiency due to the electrical charge

means that an electrostatic filter

generally offers lower breathing

resistance than a mechanical filter with

the same initial efficiency. This occurs

because fewer fibers are needed in the

electrostatic filter to achieve the same

level of efficiency as a mechanical filter.

However, the efficiency of electrostatic

filters can be significantly reduced by

exposure to certain aerosols while

mechanical filters are generally more

resistant to degradation.

Comments concerning resistance of

filters to degradation were generally of

two conflicting schools of thought. One

school favored replacing the two

proposed tests with a single, more

severe test. The other favored retaining

the two proposed tests at the same or

reduced level of severity.

Commenters opposing the proposed

classification system stated it was not a

severe enough test of resistance to filter

degradation because it did not represent

a worst-case test. They recommended

testing all filters with a DOP aerosol

with the test continued until there was

no further decrease in filter efficiency.

Those supporting this position argued

that the proposed filter classification

system could result in overexposure of

workers as workplace aerosols degrade

some filters to a level below the certified

efficiency level. It was indicated that

various workplace contaminants can

cause the beneficial filtering effects of

the charge on electrostatic filters to

become partially or totally ineffective

without indication to the wearer. As the

electrostatic charge on the filter fibers is

masked by the deposition of aerosol, the

efficiency of the filter can be reduced to

below the anticipated level of

protection, based on the certified

efficiency level. Further, these

contaminants have been identified as

solids as well as liquids. With no

warning to alert the wearer of a decrease

in the performance level of the filter,

these commenters believed that the

proposed tests to determine filter

efficiency should be modified to assure

that the filters are tested until the

minimum level of efficiency is

achieved. The stated advantage of such

an approach is that filters could be used

with any aerosol for indefinite time

periods without concern of filter

degradation.

The other school argued that the two

proposed categories were either

appropriate or too severe. They

suggested continuing with the two

categories either as proposed or with a

reduction in the amount of filter loading

(to reduce the severity of the test). They

argued that the two proposed filter tests,

being a combination of worst-case and

severe test parameters, would assure

adequate filter performance in the

workplace.

Several commenters stated that the

great majority of respirator applications

are in worksites with aerosols that do

not significantly diminish the efficiency

level of the electrostatic filters.

Workplace studies were submitted to

support the conclusion that, because of

the highly degrading nature of DOP and

the proposed high loading level, the

proposed test were many times more

severe than conditions realistically

encountered by workers. These

commenters recommended, not only the

certification of two categories as

proposed, but that the proposed test

loading levels for both the NaCl and

DOP aerosols be reduced to more

closely simulate workplace exposures.

The advantage of the proposed tests

was the benefit of potentially lower

breathing resistance, with the resulting

increased comfort, of electrostatic filters

for the great majority of respirator

wearers who are not exposed to highly

degrading workplace aerosols. Further,

the electrostatic filter types were

reported by commenters to have a

potentially lower cost than their

mechanical filter counterparts.

This final rule provides for the needs

of both the majority workers with no

need for filters highly resistant to

degradation and workers needing filters

most resistant to degradation. To that

end, this rule provides for a third

category of filters added to the two

categories provided for in the proposal.

The new filter category is tested with

the highly degrading DOP until no

further decrease in filter efficiency is

observed.

As discussed under VI. Discussion of

Final Rule, D. Section-by-Section

Discussion, § 84.170, NIOSH is

introducing a new terminology for the

three filter categories. The solid only

filters in the proposal are labeled Nseries filters in this final rule. The

proposal’s solid or liquid filters are now

labeled R-series filters. Filters of the

new, third category are labeled P-series

filters. The three categories, therefore,

provide filters for a complete range of

applications.

Further, to address concerns about the

use of A, B, and C in the proposal to

indicate the efficiency level, the final

rule uses numerical notations of 100, 99,

or 95 to indicate filter efficiency. The

rationale for retaining the proposed

efficiency levels of 99.97, 99, and 95%

is discussed in VI. Discussion of Final

Rule, D. Section-by-Section Discussion,

§ 84.170(c)(3). The terminology of this

final rule is related to that of the

proposal as follows:

Final Proposal

N100 ....... Solid only/type A.

N99 ......... Solid only/type B.

N95 ......... Solid only/type C.

R100 ....... Solid & Liquid/type A.

R99 ......... Solid & Liquid/type B.

R95 ......... Solid & Liquid/type C.

P100 ....... (Not included in proposal).

P99 ......... (Not included in proposal).

P95 ......... (Not included in proposal).

As stated in the proposal, NIOSH

selected the test criteria to be a

combination of worst-case and very

severe test conditions. The N- and Rseries filters will be tested to a specified

maximum loading level as in the

proposal. Performance of these two filter

classes at loadings beyond that

maximum will not be evaluated.

Furthermore, NIOSH is aware that few

data are available to assess the

performance of these respirators in

workplace settings over an extended

period of time. Therefore, the N- and Rseries filters will be certified with the

recognition that in some settings timeuse limitations should be applied. A

single shift limitation, for example, may

be appropriate to guard against possible

degradation of performance below the

efficiency certified by NIOSH. In

addition to possible time-use

restrictions, the N-series filters should

be restricted to use in those workplaces

free of oil aerosols because the N-series

certification tests will involve challenge

with non-degrading sodium chloride

aerosols. The R-series filters should

require no such aerosol-use restrictions

because R-series certification tests will

involve challenge with highly degrading

dioctylphthalate aerosols. Because the

P-series certification tests will involve

challenge with this highly degrading
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30343

aerosol that will continue until the filter

efficiency declines to its lowest level,

the P-series may require neither aerosoluse nor time-use limitations. As for any

filter, service time will be limited by

considerations of hygiene and increased

breathing resistance due to filter

loading.

Guidelines for the use and selection of

part 84 particulate respirators, as

described in V. Administrative and

Procedural Matters of Final Rule, B.

User’s Guide, are to be developed with

public input. The user’s guide will

include detailed guidance concerning

use limitations for these three filter

series.

D. Section-by-Section Discussion.

All sections redesignated to 42 CFR

part 84 without modification from 30

CFR part 11 are excluded in this

discussion of the final rule. The sections

redesignated without modification will

be revised, where appropriate, to:

(1) remove references to MSHA,

except for those related to certain

mining applications,

(2) update the NIOSH certifying

organization to the Certification and

Quality Assurance Branch, Division of

Safety Research, NIOSH, 1095

Willowdale Road, Morgantown, West

Virginia 26505–2888,

(3) remove references to subpart M,

pesticide respirators, and tests for

protection during abrasive blasting,

(4) correct nonsubstantive

typographical errors and reference the

new part 84 section designations, and

(5) update references to incorporationby-reference documents.

The sections redesignated without

modification are as follows:

84.1, 84.11, 84.12, 84.21, 84.22, 84.30,

84.31, 84.32, 84.34, 84.35, 84.36, 84.40,

84.41, 84.42, 84.43, 84.50, 84.51, 84.53,

84.60, 84.62, 84.63, 84.64, 84.65, 84.66,

84.70, 84.71, 84.72, 84.73, 84.74, 84.75,

84.76, 84.77, 84.78, 84.79, 84.80, 84.81,

84.82, 84.83, 84.84, 84.85, 84.86, 84.87,

84.88, 84.89, 84.90, 84.91, 84.92, 84.93,

84.94, 84.95, 84.96, 84.97, 84.98, 84.99,

84.100, 84.101, 84.102, 84.103, 84.104,

84.110, 84.111, 84.112, 84.113, 84.114,

84.115, 84.116, 84.117, 84.118, 84.119,

84.120, 84.121, 84.122, 84.123, 84.124,

84.126, 84.130, 84.131, 84.132, 84.133,

84.134, 84.135, 84.136, 84.137, 84.138,

84.139, 84.140, 84.141, 84.142, 84.143,

84.144, 84.145, 84.146, 84.147, 84.148,

84.149, 84.150, 84.151, 84.152, 84.153,

84.154, 84.155, 84.156, 84.157, 84.158,

84.159, 84.160, 84.161, 84.162, 84.163,

84.172, 84.173, 84.174, 84.175, 84.176,

84.178, 84.182, 84.190, 84.191, 84.192,

84.193, 84.194, 84.195, 84.196, 84.197,

84.198, 84.199, 84.200, 84.201, 84.202,

84.204, 84.205, 84.207, 84.250, 84.251,

84.252, 84.253, 84.254, 84.255, 84.256,

84.257, and 84.258.

The following section-by-section

analysis discusses each new or revised

section to 42 CFR part 84. All part and

section references for part 11 are to Title

30 of the Code of Federal Regulations

(30 CFR). All part and section references

for part 84 are to Title 42 of the Code

of Federal Regulations (42 CFR).

Subpart A—General Provisions

Section 84.2—Definitions

This section is redesignated and

revised from § 11.3. This section is

unmodified from the proposal.

The existing definitions for air

contamination level, Bureau,

concentration limits for radionuclides,

DOP, MESA, pesticide, radionuclides,

and smoke are deleted. These terms are

used in provisions that are modified or

deleted as a result of the filter

penetration test changes included in

this final rule. These definitions have,

therefore, become unnecessary.

The existing definition for Testing

and Certification Laboratory is modified

to reflect the present name of the

organization as the Certification and

Quality Assurance Branch. One

commenter suggested the definition of

respirator be modified to require a

respirator to have one-way airflow with

inspiratory and expiratory valves, able

to be properly positive and negative fitchecked under usual working

conditions. Additionally, this

commenter recommended adding a

definition for mask as any device that

protects the wearer against inhalation of

a hazardous atmosphere.

The primary purpose of a respirator is

to provide respiratory protection for the

wearer. Neither requiring inhalation and

exhalation valves nor reclassifying

respirators as masks would enhance

worker protection. Thus NIOSH

retained the current definition.

Section 84.3 Respirators For Mine

Rescue or Other Emergency Use In

Mines

This section is new and maintains

MSHA’s role in the approval of

respirators designed for mine rescue or

other mine emergency use. This section

is unmodified from the proposal. Under

this provision, MSHA and NIOSH will

conduct joint review and certification of

respirators used for mine emergencies

and mine rescue. This provision

recognizes MSHA’s expertise in

identifying the special needs and

considerations for respirators used in

the mining environment. This role

replaces MSHA’s existing role as a joint

approver of all respirators. Several

commenters, while endorsing the

transfer of the authority for the

regulation, recognized MSHA’s unique

expertise relating to mine-specific

respiratory protective devices. These

commenters strongly supported MSHA’s

continued close involvement in this

equipment including, but is not limited

to, filter self-rescuers, self-contained

self-rescuers, and emergency rescue

equipment.

Paragraph (a) specifies that NIOSH

and MSHA will jointly certify any

respirator designed for mine

emergencies, mine rescue or other

emergency use in mines. This joint

review and certification includes any

associated service-life plans, user’s

manuals, and other supporting

documentation. This paragraph further

specifies that certifications for these

respirators include any identified use

limitations related to mine safety and

health as a condition of certification.

Paragraph (b) specifies NIOSH and

MSHA will jointly address recall and

retrofit matters arising from field

complaints or identified deficiencies

concerning any respirators used in the

mining environment. A new

Memorandum of Understanding is to

further delineate MSHA’s role in such

matters, including participation in any

related field or manufacturing site

audits.

Subpart B—Application for Approval

Section 84.10 Application Procedures

This section is redesignated from

existing § 11.10 with only paragraph (e)

modified. This section is unmodified

from the proposal. Paragraph (e) retains

the existing requirement for inspection,

examination, and testing by MSHA of

electrical and electronic components to

be permissible in accordance with 30

CFR part 18 for respirators intended for

use in mining environments and having

permissible electrical or electronic

components. MSHA will continue to

conduct this testing and issue a separate

MSHA approval number for those

respirators found acceptable. The

process for conducting the

permissibility evaluation of these

components and their identification

remains unchanged from the existing

policies and practices.

Subpart C—Fees

Section 84.20 Examination,

Inspection, and Testing of Complete

Respirator Assemblies; Fees

This section is redesignated from

existing § 11.20, and modified only to

reflect the new particulate filter

classification scheme. This section is

unmodified from the proposal.
30344 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

Subpart D—Approval and Disapproval

Section 84.33 Approval Labels and

Markings; Approval of Contents; Use

This section is redesignated from

existing § 11.33. This section is

unmodified from the proposal.

Paragraph (b) specifies the use of the

NIOSH emblem on the approval label,

replacing the MSHA emblem.

Paragraph (e) of this section is

modified to identify the existing dust,

fume, and mist class of respirator as a

particulate respirator. The new

designation is consistent with the

testing criteria under which these

respirators are certified. The table in

paragraph (e) identifying the approval

label requirements is modified by the

removal of references specific to paint

spray and pesticide respirators, also

consistent with the changes associated

with the non-powered air-purifying

particulate filter efficiency level

determination test.

Subpart F—Classification of Approved

Respirators; Scope of Approval;

Atmospheric Hazards; Service Time

Section 84.52 Respiratory Hazards;

Classification

This section is redesignated from

existing § 11.52. This section is

unmodified from the proposal.

It is modified only to delete paragraph

(d). Reference to the pesticide

classification is no longer appropriate

with the introduction of the particulates

classification.

Subpart G—General Construction and

Performance Requirements

Section 84.61 General Construction

Requirements

This section is redesignated from

§ 11.61. This section is unmodified from

the proposal.

The provision for respirator

components to meet the permissibility

requirements of 30 CFR part 18

[paragraph (e)] has been deleted because

MSHA’s workplace regulations

separately and independently establish

this requirement for certain mining

applications. This change is consistent

with existing practice, whereby, MSHA

conducts the evaluation and testing of

these components and issues a separate

approval to cover this aspect of

respirator design.

Subpart I—Gas Masks

Section 84.125 Particulate Tests;

Canisters Containing Particulate Filters;

Minimum Requirements.

This section is redesignated from

existing § 11.102–4, without

modification except to specify the new

requirements that respirators for

protection against particulates (dusts,

fumes, mists, and smokes) in

combination with gases, vapors, or gases

and vapors, must meet. Except for

reference to the redesignated section

numbers of subpart K, this section is

unmodified from the proposal. With the

exception of the airflow resistance test

of § 84.181, these respirators are

required to meet the requirements

specified in §§ 84.170 through 84.183.

Subpart K—Non-Powered Air-Purifying

Particulate Respirators

Section 84.170 Non-Powered AirPurifying Particulate Respirators;

Description

This section, derived from § 11.130, is

revised to define non-powered airpurifying particulate respirators in a

more concise way than previously

provided for respirators designed for

protection against dusts, fumes, mists,

paint sprays, and pesticides. An

essential benefit to filter-mask

purchasers of new certifications under

this part is that they will no longer have

to be knowledgeable about the

contaminant particle sizes. Under the

provisions of this part, NIOSH will

certify filter performance with a test

aerosol size chosen so that filter

performance for essentially all other

aerosol sizes will be higher than that

certified by NIOSH.

Paragraph (a) describes non-powered

air-purifying particulate respirators as

those with air drawn through the air

purifying filter as a result of the negative

pressure generated with the inhalation

of the wearer. Non-powered respirators

include respirators that depend solely

on the inhalation and exhalation of the

wearer to provide an adequate supply of

purified breathing air to the wearer.

These respirators are designed with

filters to provide respiratory protection

against atmospheres that contain

adequate oxygen to support life and are

contaminated with particulates not

immediately dangerous to life or health.

Particulates for which these respirators

provide protection include

contaminants such as dusts, fumes,

mists and smoke.

Paragraph (b) establishes three series

of non-powered air-purifying particulate

respirators designated as N-series, Rseries, and P-series. The N-series

respirators are intended for use in those

workplaces free of oil aerosols. The Rseries and P-series respirators are

intended for removal of any particulate

that includes oil-based liquid

particulates.

Paragraph (c) establishes the

classification of non-powered airpurifying particulate respirators

according to the efficiency level of the

filter(s) when tested to the requirements

of part 84.

Paragraph (c)(1) requires N100, R100,

and P100 filters to demonstrate a

minimum efficiency level of 99.97

percent.

Paragraph (c)(2) requires N99, R99,

and P99 filters to demonstrate a

minimum efficiency level of 99 percent.

Paragraph (c)(3) requires N95, R95,

and P95 filters to demonstrate a

minimum efficiency level of 95 percent.

As discussed previously, some

commenters supported the twoclassification system that was proposed

while others stated only one class was

needed. NIOSH agrees with commenters

that a class of respirators should be

available for use in environments where

the filter efficiency level is not

diminished by the worksite aerosol (Nseries). Insufficient studies have been

conducted to definitively characterize

workplace aerosols and their effect upon

filter efficiencies. Therefore, NIOSH will

certify the new filter categories

recognizing potential aerosol-use and

time-use limitations as discussed above

and in VI. Discussion of Final Rule, C.

Filter Classification.

Many commenters expressed

concerns of confusion in the selection of

the proposed new particulate

respirators. Various commenters

pointed to the proposed multiple (two)

classes, class nomenclatures (Solid Only

and Liquid and Solid), type

nomenclature (A, B, and C), and filter

color requirements as sources for this

confusion.

Several commenters recommended

that the designations (A, B, and C) for

the types be changed to eliminate

confusion of the particulate respirator

classes with other approved respirator

types. Some of these commenters

suggested nomenclatures similar to P3,

P2, and P1 used for particulate filters in

the European community. Another of

these commenters recommended a

further delineation of the alphabetic

notation with each type and class

designated by a unique letter (A, B, C,

D, E, and F) for clarification. Still

another commenter suggested that the

nomenclatures be changed but made no

specific suggestion.

To address concerns about confusion

in the selection of respirators under part

84, NIOSH has developed new category

classifications and will develop a user’s

guide, as discussed in V. Administrative

and Procedural Matters of Final Rule, B.

User’s Guide.

Numerous comments were also

received regarding the proposed

efficiency levels. Many commenters
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30345

supported the three efficiency levels as

proposed, while others suggested levels

different than proposed. A 90% filter

efficiency level was the most frequently

recommended alternative, sometimes

suggested as a fourth class.

NIOSH recognizes that the efficiency

requirements contained in the proposed

rule are to some extent technologyforcing. However, HEPA-level

respirators that perform at an efficiency

level proposed under part 84 have been

available for years. One commenter (a

manufacturer) stated that the technology

for producing 95% (Class C) efficiency

level respirator is practical, reasonable,

and available. This commenter further

stated that a Class C respirator could be

marketed at a price not exceeding the

price of a 30 CFR part 11 disposable

DFM respirator.

The principal advantage of a 90%

efficiency class would be to permit a

larger percentage of filters certified

under part 11 to be certified without

modification under the new part 84

tests. The best performing of the current

DM and DFM respirators are expected to

meet the requirements of a 95% class,

but a significant number of DM

respirators would not be expected to

meet the requirements even of a 90%

class. Limiting the minimum filter

efficiency to 95% will minimize worker

exposure to airborne contaminants from

filter penetration. This is important

because it is the most controllable

element of protection afforded by

respiratory protection programs. The

human variables in these programs are

more difficult to guarantee: that workers

are provided the appropriate class of

respirator; that the workers are

effectively fit tested; that they achieve

and maintain an effective face seal each

time they wear a respirator; and that

they replace disposable respirators and

filters before their effectiveness is

diminished. Some commenters urged,

for these reasons, that all filters should

have greater than 99% efficiency. Such

high filter efficiency poses technologic

challenges, increases costs to

manufacturers and users, and increases

breathing difficulty for respirator

wearers. NIOSH believes that a 95%

minimum efficiency best balances the

public health concern and these

competing considerations.

Although a number of manufacturers

have indicated they are prepared now to

submit filters for certification under

these new test procedures, there may be

some who are not. These manufacturers

will have three years to develop this

capacity while they continue to market

their existing products.

Section 84.171 Non-powered Airpurifying Particulate Respirators;

Required Components

This section is redesignated from

existing § 11.131, modified only to

incorporate the new terminology of

particulates to describe dusts, fumes

and mists. This section is unmodified

from the proposal, except for the title

change.

Section 84.177 Inhalation and

Exhalation Valves; Minimum

Requirements

This section is redesignated from

existing § 11.137, modified only to

delete reference to the silica dust tests

for single-use respirators of § 11.140–5.

This section is unmodified from the

proposal. The respirator performance

requirements of these tests are replaced

by the non-powered air-purifying

particulate filter efficiency level

determination test contained in this

rule.

Section 84.179 Non-powered Airpurifying Particulate Respirators; Filter

Identification

This section requires the

identification of non-powered airpurifying particulate respirators by

labeling with a new classification

system for the series and efficiency of

the filters. The new terminology of nonpowered air-purifying particulate

respirator replaces the existing dust,

fume, and mist respirator, as discussed

previously.

The requirement for the manufacturer

to specify the filter-series and efficiency

level classification in the certification

application is contained in paragraph

(a). This classification would include

the series of the filter and the expected

efficiency of the filter based on the test

requirements specified in § 84.182.

The information to be included on the

label of a filter for a certified nonpowered air-purifying particulate

respirator is specified in paragraphs

(b)(1) through (b)(9). This labeling

defines the efficiency level achieved in

the performance testing (i.e., 99.97%,

99%, or 95%) and the series of the filter

(i.e., N, R, or P). This information is

necessary to allow the user to make an

informed decision on selecting the

appropriate respiratory protection.

To facilitate this selection process, the

P100 filters are color coded magenta to

allow them to be easily distinguished

from the other filter types. The filters

other than the P100 can be of any color

except magenta. This color coding is

consistent with the present universally

accepted color code convention which

identifies the best performing filters

(HEPAs) by their magenta color.

NIOSH has modified these labeling

requirements from the proposal in

agreement with the commenters who

stated that the labelling should clearly

state the certified efficiency rating

numerically and include the series on

the filter, filter package, or respirator

box.

One commenter suggested that all

classes of certified respirators should be

color coded for user identification;

another stated that the high efficiency

filters of each series should be magenta.

It was also requested that color coding

as well as letter designation be specified

for all respirators. A more complex

color-coding system may add confusion

to the respirator selection process. With

the more descriptive classification

identifying labels required by this final

rule, the potential for confusion in

selection of the appropriate respirator

has been reduced. Therefore, NIOSH has

not adopted these suggestions.

Section 84.180 Airflow Resistance

Tests

Section 84.180 is derived from

§ 11.140–9. It is modified to delete the

final inhalation resistance requirements.

The non-powered air-purifying

particulate filter efficiency level

determination tests are not designed to

simulate loading of the filter at the

worksite. Therefore, these requirements

are not appropriate with the

introduction of these new tests.

Paragraph (a) provides for

determining the inhalation-resistance of

the complete non-powered air-purifying

particulate respirator. This value

corresponds to the pressure drop across

the complete respirator mounted on a

test fixture with air drawn inward

through it at a continuous rate of 85±2

liters per minute. Tolerance limits have

been added to the test flow rates as

suggested by commenters.

The final rule does not include final

breathing resistance limits as requested

in some comments. The final breathing

resistances previously included in the

30 CFR part 11 requirements were based

on filters loading and clogging with a

silica dust. The loading experienced at

actual worksites is not represented by

such a test. The inclusion of final

breathing resistances as part of a

certification would primarily address

two concerns. The first is that the

breathing resistance does not exceed

physiological limits or pose undue

discomfort on the wearer. Wearers will

replace filters before breathing

resistances reach such levels. The

second concern is that the filter

efficiency is still at an acceptable level

at the certification final resistance value.

The filter efficiency level determination
30346 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

and respirator classifications provided

for in this rule are sufficiently severe to

alleviate this concern.

One commenter questioned NIOSH’s

intent for restricting final inhalation

resistance for particulate filters used in

conjunction with chemical cartridges.

This commenter pointed to § 84.203

requirements which specify maximum

allowable final inhalation resistances for

these combinations. The final inhalation

value is to be measured at the end of the

service life tests for the chemical

cartridge portion of the combination.

NIOSH will continue to measure the

initial and final inhalation and

exhalation resistances of the

combination in conjunction with the

service life test of the chemical

cartridge. The inhalation and exhalation

resistances need not be measured for

these combinations in conjunction with

the particulate efficiency level

determination tests.

Paragraph (b) states the inhalation

resistance of the complete respirator is

not to exceed 35 millimeters of watercolumn height. The exhalation

resistance of the complete respirator is

not to exceed 25 millimeters of watercolumn height.

The proposed rule would have

limited the inhalation and exhalation

resistances to 30 and 20 millimeters of

water-column height, respectively.

Several commenters requested that the

values be increased. Increased breathing

resistance values will permit the

effective use of presently available filter

material in respirators re-designed to

meet the efficiency level determination

tests at a reasonable cost. Others

expressed a concern that respirators

with higher breathing resistances are

less likely to be fitted properly, often

intentionally due to the discomfort.

Commenters expressed that this may be

true in the health-care profession where

the use of certified respirators is new.

The final rule has increased the

maximum acceptable breathing

resistance values slightly from the

proposed levels to those suggested by

commenters. The proposed resistance

levels of 30 and 20 millimeters of watercolumn height corresponded to the

maximum allowable resistance values in

part 11 for any particulate respirator.

The new resistance levels remain below

the acceptable limits for some nonparticulate respirator classes under the

existing part 11 provision. For example,

chemical cartridge respirators, which

have use patterns similar to particulate

filter respirators, have a maximum

initial inhalation resistance of 40

millimeters water-column height. This

increase in acceptable breathing

resistance for particulate respirators will

enable manufacturers to produce

respirators meeting the new

requirements more expeditiously and at

lower cost than the proposal would

have allowed. This small increase in

maximum allowable breathing

resistance for particulate respirators

does not add substantially to

physiologic burden for respirator users,

and will be compensated by increased

worker protection provided by the new

filter efficiency tests and classification

system. The acceptable breathing

resistance levels for the non-particulate

respirator classes are not affected.

Section 84.181 Non-powered AirPurifying Particulate Filter Efficiency

Level Determination

This section is new and specifies the

test criteria and acceptable performance

criteria for the new non-powered airpurifying particulate filter efficiency

level determination. This section has

been retitled from particulate

instantaneous-penetration-filter test in

response to a comment. The new title

more appropriately represents the intent

of the tests in this section to determine

the efficiency level of the filters.

Paragraph (a) requires the filter

efficiency testing of 20 filters of each

non-powered air-purifying particulate

respirator model. Testing is conducted

using a solid sodium chloride or

equivalent particulate aerosol for Nseries certification or a dioctyl phthalate

or equivalent liquid particulate aerosol

for R-series and P-series certification.

Paragraph (b) requires the filters,

including holders and gaskets; when

separable, to be tested mounted on a test

fixture in the manner as used on the

respirator. This provides for testing of

the assembly in a configuration as it will

be actually used.

Paragraph (c) describes

preconditioning requirements for the 20

N-series filters to be tested. After

removal from their packaging, the 20

filters are placed in an environment of

85±5 percent relative humidity at 38±2.5

°C for 25±1 hours. The filters shall be

stored in a gas-tight container until

tested. Testing for the filter efficiencies

must be performed within 10 hours

following preconditioning. These

preconditioning requirements apply

only to N-series filters differing from the

proposal which would have had filters

of each series subjected to

preconditioning.

Paragraph (d) provides for blocking

the exhalation valves to ensure that any

valve leakage is not included in the

filter efficiency level evaluation. This

only applies when the filters do not

have separable holders and gaskets.

Paragraph (e) specifies the continuous

test aerosol flow rates for the filter

efficiency testing. Single filters are

tested at a rate of 85±4 liters per minute;

filters used in pairs are tested at a rate

of 42.5 ± 2 liters per minute through

each filter.

Paragraph (f) describes the

penetration test aerosols and the test

criteria to be used. A sodium chloride

or equivalent solid aerosol is used when

testing for filter efficiency for N-series

filters. A neutralized-dioctyl phthalate

(DOP), or equivalent oil, liquid aerosol

is specified as the testing agent when

testing for filter efficiency of R- and Pseries filters. For P-series filters, the

filter efficiency test will be continued

until minimum efficiency is obtained.

However, for N- and R-series respirators

it will be terminated when an aerosol

mass of 200±5 mg has contacted the

filter unit, if minimum efficiency has

not been obtained.

Paragraph (f)(1) identifies the test

conditions for the sodium chloride or

equivalent solid aerosol to be at 25±5 °C

and relative humidity of 30±10 percent.

The aerosol specified to be used in these

tests will be neutralized to the

Boltzmann equilibrium state, and the

maximum concentration will not exceed

200 mg/m3. The relative humidity of the

sodium chloride aerosol has been

changed from the proposal in response

to a comment. This change, a small

increase in the relative humidity of the

aerosol, allows testing at the values

normally encountered with the test

instruments commonly used.

Paragraph (f)(2) specifies the DOP or

equivalent oil liquid particulate aerosol.

The test conditions for the liquid

aerosol are specified to be at 25±5 °C.

The aerosol specified to be used in these

tests will be neutralized to the

Boltzmann equilibrium state, and the

maximum concentration will not exceed

200 mg/m3.

Paragraph (g) specifies the particle

size limitations at the test conditions for

the filter efficiency test aerosols. The

sodium chloride aerosol will have a

particle size distribution with count

median diameter between 0.075±0.020

micrometer and a standard geometric

deviation not exceeding 1.86. The liquid

particulate aerosol has a particle size

distribution with count median

diameter between 0.185±0.020

micrometer and a standard geometric

deviation not exceeding 1.60. NIOSH

will make these particle size

distribution determinations at the

specified test conditions with a

scanning mobility particle sizer (SMPS)

or equivalent. The specification of a

scanning mobility particle sizer

represents newer technology than the
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30347

differential mobility particle sizer that

was specified in the proposal. This

reference to the newer technology was

added in response to comments from

the public. NIOSH will accept

manufacturer’s size verification data

determined by SPMS or an equivalent

particle sizing instrument that provides

particle sizing information consistent

with an SPMS.

Paragraph (h) requires the efficiency

of the filter (i.e., the amount of aerosol

particles that pass through the filter) to

be monitored and recorded throughout

the test period by a suitable forwardlight-scattering photometer or

equivalent instrumentation.

Paragraph (i) requires the minimum

filter efficiency for each of the 20 filters

to be determined and recorded. The

minimum efficiency of each tested filter

is to be greater than or equal to 99.97%

for P100, R100 and N100 filters; 99% for

P99, R99 and N99 filters; and 95% for

P95, R95 and N95 filters.

Many comments were received on all

aspects of the testing requirements.

Comments were received regarding the

proposed loading levels, test agents,

preconditioning requirements, number

of filters to be tested, and test

equipment specifications.

The proposal included a statistical

treatment of the filter efficiency test

results (U statistic). Thirty filter samples

were to be tested for each certification

application. The number of samples

tested and the test statistic used in the

treatment of the data was intended to

provide a 95% confidence interval of

95% conformance (95% tolerance

interval) of manufacturers’ product to

the certification criterion. These

methods rely on the applicability of the

‘‘normal’’ or Gaussian distribution for

test data. A similar statistical treatment

of the test data was included in the 1987

NIOSH proposal.

A number of commenters expressed

concern with the use of a NIOSH

proposed U statistic (based on a 95%

tolerance interval for the 95th

percentile) to determine if the

performance of filters submitted by

manufacturers meet the requirements

for requested classification (type).

Comments concerned the use of the

constant 2.22 for the calculation of the

U statistic, suggesting that this is too

strict a criterion for manufacturers to

meet and implying that 95% tolerance

intervals based on some lower

percentile (e.g., 90th) would be more

appropriate. Other comments concerned

the distribution assumptions inherent in

the calculation of the U statistic.

Commenters expressed concern that the

assumption that test data represent a

sample from a Gaussian distribution is

incorrect and that the application of

tolerance interval methods for this data

is inappropriate.

Other commenters questioned

NIOSH’s justification to ‘‘knowingly’’

allow the certification of respirators that

do not meet the performance

requirements. They interpreted the

statistical criterion as NIOSH accepting

up to 5% of the distributed respirators

to be less than the stated class

minimum. This analysis of the data

would imply that some of the

distributed certified respirators perform

below the inferred minimum

performance level of its class. The

commenters expressed concern that this

would cause an unacceptably large

number of workers to have inadequate

respirator protection.

One commenter pointed out that the

use of the U statistic was an attempt to

predict future production variability.

This commenter further asserted that

respirators submitted for certification

testing do not constitute a random

sample of a manufacturer’s product.

Production variability, this commenter

continued, is to be controlled by the

separate quality control program.

NIOSH concurs with the commenter

that the proposed statistical approach

addressing pre-market production

samples is inconsistent with

determining product quality in a

controlled process. NIOSH further

agrees that the samples submitted for

certification testing are not random

samples. Therefore, the final rule does

not include an acceptance criterion

based upon the statistical treatment of

test data.

A significant portion of the cost

attributed to the proposed regulations

(25 to 30% of the cost, by one estimate)

resulted from the statistical treatment of

data. Manufacturers stated that this cost

impact would be reduced if a 95%

tolerance interval based on a 90

percentile (i.e., 95% confidence of 90%

conformance) were used. Manufacturers

and others suggested that a pass/fail

criterion should be offered. Several

commenters suggested reducing the

number of test samples and using a

pass/fail criterion.

A pass/fail criterion is consistent with

the current respirator acceptance

criterion, and is generally accepted as

appropriate for a certification program

with testing of pre-production units.

The pass/fail criterion presents another

advantage in that it establishes the

minimum acceptable performance level

consistent with the class definition. A

member of a 95% class will not be in

compliance with the certification if it

has an efficiency below that level when

tested. The statistical test criterion

could allow some individual units to

have performance test measurements

below 95% but still meet certification

requirements.

Based on these comments, NIOSH has

reconsidered the use of the tolerance

interval approach for the analysis of

respirator performance data. NIOSH

agrees that the application of the

tolerance interval approach is

inconsistent with type approval and

recognizes that respirators submitted for

certification do not constitute a random

sample of a manufacturer’s product.

Consequently, the final rule has been

modified to test 20 respirators for

laboratory performance, with

certification if all 20 units meet the

specifications.

The proposal specified both sodium

chloride (NaCl) as the solid test aerosol

and dioctyl phthalate (DOP) as the

liquid test aerosol. Although DOP is a

suspected carcinogen, the set up of the

test instruments precludes laboratory

personnel exposure to the aerosol.

Sodium chloride does not pose a

suspected health hazard. Dioctyl

phthalate is the most severe liquid, or

degrading test aerosol known. It has

been used for decades as the test aerosol

for certification of the best (HEPA) part

11 filters. Sodium chloride is a solid test

aerosol that provides some degrading

characteristics. Sodium chloride has

also been used for years as the solid test

agent in the European (CEN)

certification standards.

No comments were received against

the use of NaCl as the solid test aerosol

for non-powered respirators. One

commenter, a former employee of the

Department of Defense, questioned its

use because the military does not use it

in their mask testing. Another

commenter, accepting the use of NaCl,

stated that part 84 should allow

equivalent test aerosols as well. The

only negative comments received to the

NaCl test aerosol were due to the

difficulties associated with the testing of

powered air-purifying respirators

(PAPRs). The requirements for PAPRs

was discussed previously in V.

Discussion of Final Rule, B. Powered

Air-Purifying Particulate Respirators.

Commenters interested in the use of

certified respirators for protection

against TB suggested the use of

biological agents (bioaerosols) for the

certification testing. It is not necessary

to subject filter respirators to a

bioaerosol as a condition of

certification. By using test aerosols of

the most penetrating size range, the

efficiency-level determination of the

certification testing will be the lowest

obtainable for any size aerosol.

Therefore, the efficiency level against
30348 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

any bioaerosol for any certified

respirator will meet or exceed the

certified efficiency level.

Comments concerning the choice of

liquid test aerosols were varied. Several

different test agents were suggested

including paraffin oil, Emery 3004, and

hydrofluoric acid. Paraffin oil was

suggested because it is consistent with

the European (CEN) standards. The U.S.

military has adopted Emery 3004 as a

DOP replacement in instantaneous

testing of filter efficiency. A commenter

suggested that because hydrofluoric acid

aerosol is common in many industries,

it would be a more realistic test agent.

Each of the suggested alternative

liquid aerosols would provide

essentially the same initial or lightly

loaded filter efficiency levels. The

initial efficiency level of a filter is

defined primarily by the particle size of

the aerosol, not its degrading ability.

The CEN standards use paraffin oil as

the liquid test aerosol, but the filters are

not loaded to a significant level. Emery

3004 has been adopted as a replacement

for DOP by the military in initial

efficiency testing as performed for the

part 11 HEPA filters. Unlike DOP, none

of the recommended alternative test

aerosols provide severe degrading

effects of the filters. This severity is an

integral part of the part 84 testing, and

addressing the uncertainties of the

effects of actual workplace aerosols.

In considering these options, NIOSH

is aware that no single test agent is used

by every prominent standard-setting

agency or organization. The CEN

standard uses NaCl as a solid test

aerosol. The current draft for revising

the ANSI Z88.8 standard proposes NaCl

and DOP as the test aerosols. No choice

of test aerosol would provide

consistency with all other standards, as

sought by commenters. A fundamental

purpose of the new testing standards is

to assure that at least one class of filters

is highly resistant to degradation by

workplace aerosols. The DOP aerosol

was selected for this purpose

specifically because of its severe effect

on filter efficiency level. The proposed

alternatives demonstrate less severe

effects on the filter media; therefore,

they have been considered

inappropriate for the evaluation

intended by NIOSH.

The generation method of dioctyl

phthalate aerosol was a concern to many

commenters. Commenters questioned

the particle size distribution for this test

aerosol specified in the proposal being

greater than that specified in the

existing part 11 requirements.

Commenters also questioned differences

in test results based on the use of

thermally generated (hot) or coldnebulized DOP aerosol. Although the

proposal did not specify any aerosol

generation technique to be used for DOP

testing, much of NIOSH’s research used

as a basis for the proposal was

performed with cold-nebulized DOP

and NIOSH testing has demonstrated

that correlation in results obtained

between the two aerosol generation

techniques is possible. Some

commenters believed that the DOP

aerosol generation method must be

specified to ensure reproducible test

results. These commenters used data

from Industrial Safety Equipment

Association-sponsored ‘‘round robin’’

testing of mechanical and electrostatic

filter material. Complete data and

specifics of the round robin testing were

not provided to NIOSH. These tests

were conducted among the majority of

the air-purifying respirator

manufacturers that are ISEA members.

The test results indicated excellent

correlation between the two aerosol

generation methods for efficiency of

standardized mechanical filter media.

For standardized electrostatic media, a

divergence in efficiency with increased

filter loading was reported between the

two aerosol generation methods. These

commenters also reported that both the

initial and stabilized efficiencies of the

electrostatic media correlated well

between the two aerosol generation

methods. The divergence reported

appears to be a different degradation

rate between the two aerosols.

Moreover, several of the participants

provided some additional insights into

the circumstances of the testing. A

significant portion of the manufacturers

had recently acquired the coldnebulized test instruments. The

reproducibility problems reported, they

admitted, could have resulted from

operator inexperience. One of the

participants with extensive experience

with both aerosol generation methods

related some of the experience gained

by that manufacturer. Excellent

correlation is maintained between this

commenter’s numerous cold-nebulized

DOP instruments in use world-wide.

Also, the commenter reported having

encountered no reproducibility

problems between thermally-generated

and cold-nebulized instruments in

testing electrostatic media when new

DOP is used.

In NIOSH testing, some tests have

provided good correlation of results

between the two aerosol generation

methods, while others have not. DOP

changes chemically as it ages, becoming

less pure. The thermal-generation

method induces a similar chemical

change, simulating accelerated aging of

the DOP. Recent NIOSH testing

indicates that the chemically-changed

DOP may cause the test instruments to

fluctuate from the stated testing

parameters. If monitored closely, and

kept within the specified parameters,

equivalent results are obtained with

either aerosol generation method.

Therefore, to accommodate these

concerns, the final rule specifies a test

using a neat cold-nebulized DOP test, or

equivalent test. Allowing equivalent test

methods permits the use of tests that

respirator manufacturers may have

already developed. As part of the

established certification process, NIOSH

evaluates the test results submitted by

the applicant by comparing them to the

results of NIOSH testing. Any test

method yielding results equivalent to

the NIOSH testing will be acceptable.

To further address the testing

reproducibility concerns expressed by

commenters, NIOSH is initiating a

program whereby a standard mechanical

and electrostatic filter media sample

will be made available upon request for

applicant correlation testing. NIOSH

will run characterization tests on these

standardized media and send a data

sheet showing the test results with the

samples. NIOSH has traditionally

conducted correlation testing for

applicants requesting such testing to

document the agreement of their test

instruments and procedures and those

of NIOSH. This new procedure will

continue the service provided to the

applicants of assuring that the results

they obtain on their instruments and

with their procedures provide results

comparable with NIOSH’s certification

tests. This new process will reduce the

NIOSH resource requirements for

corroborating the test results of the large

number of applicants that NIOSH

anticipates will be requesting this

service and expedite the correlation

process.

Several comments were received on

the humidity preconditioning

requirement for filters. One commenter

stated that the proposed

preconditioning time (24 hours) was

inadequate to have much of an effect on

the performance of electrostatic filter

media. The commenter suggested a

thirty-day preconditioning period.

Information provided regarding the

ISEA round-robin testing stated that the

effects of the preconditioning were

insignificant when testing with the DOP

aerosol. This assessment agrees with

NIOSH testing experience. The other

commenters had concerns that the

proposal did not provide: detail

regarding uniform preconditioning, the

size of the container, the allowable time

after conditioning at which filter media

must be placed within the container and
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30349

the allowable time for the filter to

remain within the container until tested.

The final rule has been modified to

require only N-series filters be taken out

of their packaging and humidity

preconditioned prior to filter efficiency

level testing at 85±5 percent relative

humidity at 38±2.5 °C for 25±1 hours.

The final rule states that following the

preconditioning, the filters shall be

sealed in a gas-tight container and tested

within 10 hours. R- and P-series filters

do not have to be preconditioned

because they are tested against DOP

which is much more severe than

humidity in regard to reducing filter

efficiency. The preconditioning

requirement is retained for the N-series

filters to address the effect of humidity

on the filter’s efficiency because the

sodium chloride aerosol is less severe

than DOP in reducing filter efficiency.

The 10-hour limitation on storage of the

filters before efficiency testing will

eliminate the variability concerns.

The final rule has been modified to

specify a scanning mobility particle

sizer (SMPS) or equivalent, as

recommended by commenters, to be

consistent with the latest technology.

One commenter suggested a flame

photometer be allowed for measurement

of sodium chloride. The same

commenter also stated that other sizing

devices such as the Tyndall Owl have

been used for years and should be an

acceptable measuring instrument.

NIOSH is aware that other

instrumentation can provide sizing

information that can equate to the

values specified in the rule. In

specifying the particle size, it is

important to identify the technology

used in its determination. The

differential mobility particle sizer

(DMPS) was specified in the proposed

rule because this is the technology

traditionally used by NIOSH to

determine the particle sizes of this test.

The use of these other instruments is

acceptable and all other such equipment

does not have to be specified in the final

rule. To make size verification

measurements manufacturers may use

any particle sizing instrument that

provides particle sizing information

consistent with an SPMS.

Subpart L—Chemical Cartridge

Respirators

Section 84.203 Breathing Resistance

Tests; Minimum Requirements

This section is redesignated from

existing § 11.162–1. This section is

unmodified from the proposal.

It is modified only to delete reference

to various classifications, such as paints

and pneumoconiosis and fibrous

producing dusts, that are no longer

appropriate with the introduction of the

particulates classification with the new

instantaneous-penetration test.

Section 84.206 Particulate Tests;

Respirators With Filters; Minimum

Requirements; General

This section is redesignated from

existing § 11.162–7. This section is

unmodified from the proposal. It is

modified only to delete reference to

various classifications, such as paints

and pneumoconiosis and fibrous

producing dusts, that are no longer

appropriate with the introduction of the

particulates classification with the new

instantaneous-penetration test.

Subpart KK—Dust, Fume, and Mist;

Pesticide; Paint Spray Respirators and

Combination Gas Masks

This subpart has been added to

continue the part 11 requirements for

the existing dust, fume, and mist;

pesticide; paint spray respirators and

combination gas masks during the

transition period to part 84.

These sections are derived from

existing 30 CFR part 11, subpart K. They

are modified to update them to part 84

section numbers.

This subpart also included the

upgraded requirements for PAPRs to

include only high efficiency filters

(HEPA).

Derivation Table

The following derivation table lists (1)

each section number of the final rule

(New Section); and (2) the section

number of the existing standard from

which the proposed standard is derived

(Old Section).

DERIVATION TABLE

New section Old section

42 CFR 30 CFR

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DERIVATION TABLE—Continued

New section Old section

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
30350 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

DERIVATION TABLE—Continued

New section Old section

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

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

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

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

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

84.144 ................... 11.124–1

84.145 ................... 11.124–2

84.146 ................... 11.124–3

84.147 ................... 11.124–4

84.148 ................... 11.124–5

84.149 ................... 11.124–6

84.150 ................... 11.124–7

84.151 ................... 11.124–8

84.152 ................... 11.124–9

84.153 ................... 11.124–10

84.154 ................... 11.124–11

84.155 ................... 11.124–12

84.156 ................... 11.124–13

84.157 ................... 11.124–14

84.158 ................... 11.124–15

84.159 ................... 11.124–16

84.160 ................... 11.124–17

84.161 ................... 11.124–18

84.162 ................... 11.124–19

84.163 ................... 11.124–20

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

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

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

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

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

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

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

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

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

84.179 ................... New.

84.180 ................... 11.140–9

84.181 ................... New.

84.182 ................... 11.140–10

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

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

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

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

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

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

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

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

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

84.199 ................... 11.158–1

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

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

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

84.203 ................... 11.162–1

84.204 ................... 11.162–2

84.205 ................... 11.162–3

84.206 ................... 11.162–7

84.207 ................... 11.162–8

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

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

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

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

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

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

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

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

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

84.1100 ................. New.

84.1101 ................. 11.3

84.1102 ................. 11.20

84.1103 ................. 11.33

84.1130 ................. 11.102–4, 11.130,

11.170

84.1131 ................. 11.91, 11.131,

11.171

DERIVATION TABLE—Continued

New section Old section

84.1132 ................. 11.95, 11.132,

11.175

84.1133 ................. 11.96, 11.133,

11.176

84.1134 ................. 11.97, 11.134,

11.177

84.1135 ................. 11.98, 11.135,

11.178

84.1136 ................. 11.99, 11.136,

11.179

84.1137 ................. 11.100, 11.137,

11.180

84.1138 ................. 11.101, 11.138,

11.181

84.1139 ................. 11.139, 11.182

84.1140 ................. 11.140

84.1141 ................. 11.140–1

84.1142 ................. 11.140–2

84.1143 ................. 11.140–3

84.1144 ................. 11.140–4

84.1145 ................. 11.140–5

84.1146 ................. 11.140–6

84.1147 ................. 11.140–7

84.1148 ................. 11.140–8

84.1149 ................. 11.140–9

84.1150 ................. 11.140–10

84.1151 ................. 11.140–11

84.1152 ................. 11.140–12

84.1153 ................. 11.102–4

84.1154 ................. 11.172, 11.173

84.1155 ................. 11.174

84.1156 ................. 11.183, 11.183–1,

11.183–3, 11.183–

4, 11.183–5,

11.183–6, 11.183–

7

84.1157 ................. 11.162, 11.162–1,

11.162–4, 11.162–

5, 11.162–6,

11.162–8

84.1158 ................. 11.162–7

Distribution Table

The following distribution table lists

(1) the section number of the existing

part 11 standard (Old Section); and (2)

each section number of the final rule

(New Section).

DISTRIBUTION TABLE

Old section New section

30 CFR 42 CFR

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

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

11.2–1 ................... Removed.

11.3 ....................... 84.2, 84.1101

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

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

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

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

11.20 ..................... 84.20, 84.1102

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

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

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

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

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

11.33 ..................... 84.33, 84.1103

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

DISTRIBUTION TABLE—Continued

Old section New section

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11.79–1 ................. 84.80

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

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

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

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

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

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

11.85–1 ................. 84.86

11.85–2 ................. 84.87

11.85–3 ................. 84.88

11.85–4 ................. 84.89

11.85–5 ................. 84.90

11.85–6 ................. 84.91

11.85–7 ................. 84.92

11.85–8 ................. 84.93

11.85–9 ................. 84.94

11.85–10 ............... 84.95

11.85–11 ............... 84.96

11.85–12 ............... 84.97

11.85–13 ............... 84.98

11.85–14 ............... 84.99

11.85–15 ............... 84.100

11.85–16 ............... 84.101

11.85–17 ............... 84.102

11.85–18 ............... 84.103

11.85–19 ............... 84.104

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

11.91 ..................... 84.111, 84.1131

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

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

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

11.95 ..................... 84.115, 84.1132

11.96 ..................... 84.116, 84.1133

11.97 ..................... 84.117, 84.1134

11.98 ..................... 84.118, 84.1135

11.99 ..................... 84.119, 84.1136

11.100 ................... 84.120, 84.1137

11.101 ................... 84.121, 84.1138

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

11.102–1 ............... 84.122

11.102–2 ............... 84.123

11.102–3 ............... 84.124

11.102–4 ............... 84.125, 84.1130,

84.1153

11.102–5 ............... 84.126
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30351

DISTRIBUTION TABLE—Continued

Old section New section

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11.124–1 ............... 84.144

11.124–2 ............... 84.145

11.124–3 ............... 84.146

11.124–4 ............... 84.147

11.124–5 ............... 84.148

11.124–6 ............... 84.149

11.124–7 ............... 84.150

11.124–8 ............... 84.151

11.124–9 ............... 84.152

11.124–10 ............. 84.153

11.124–11 ............. 84.154

11.124–12 ............. 84.155

11.124–13 ............. 84.156

11.124–14 ............. 84.157

11.124–15 ............. 84.158

11.124–16 ............. 84.159

11.124–17 ............. 84.160

11.124–18 ............. 84.161

11.124–19 ............. 84.162

11.124–20 ............. 84.163

11.124–21 ............. Removed.

11.124–22 ............. Removed.

11.124–23 ............. Removed.

11.124–24 ............. Removed.

11.130 ................... 84.170, 84.1130

11.131 ................... 84.171, 84.1131

11.132 ................... 84.172, 84.1132

11.133 ................... 84.173, 84.1133

11.134 ................... 84.174, 84.1134

11.135 ................... 84.175, 84.1135

11.136 ................... 84.176, 84.1136

11.137 ................... 84.177, 84.1137

11.138 ................... 84.178, 84.1138

11.139 ................... 84.1139

11.140 ................... 84.1140

11.140–1 ............... 84.1141

11.140–2 ............... 84.1142

11.140–3 ............... 84.1143

11.140–4 ............... 84.1144

11.140–5 ............... 84.1145

11.140–6 ............... 84.1146

11.140–7 ............... 84.1147

11.140–8 ............... 84.1148

11.140–9 ............... 84.180, 84.1149

11.140–10 ............. 84.182, 84.1150

11.140–11 ............. 84.1151

11.140–12 ............. 84.1152

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

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

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

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

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

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

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

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

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

11.158–1 ............... 84.199

DISTRIBUTION TABLE—Continued

Old section New section

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

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

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

11.162 ................... 84.1157

11.162–1 ............... 84.203, 84.1157

11.162–2 ............... 84.204

11.162–3 ............... 84.205

11.162–4 ............... 84.1157

11.162–5 ............... 84.1157

11.162–6 ............... 84.1157

11.162–7 ............... 84.206, 84.1158

11.162–8 ............... 84.207, 84.1157

11.170 ................... 84.1130

11.171 ................... 84.1131

11.172 ................... 84.1154

11.173 ................... 84.1154

11.174 ................... 84.1155

11.175 ................... 84.1132

11.176 ................... 84.1133

11.177 ................... 84.1134

11.178 ................... 84.1135

11.179 ................... 84.1136

11.180 ................... 84.1137

11.181 ................... 84.1138

11.182 ................... 84.1139

11.183 ................... 84.1156

11.183–1 ............... 84.1156

11.183–2 ............... Removed.

11.183–3 ............... 84.1156

11.183–4 ............... 84.1156

11.183–5 ............... 84.1156

11.183–6 ............... 84.1156

11.183–7 ............... 84.1156

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

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

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

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

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

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

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

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

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

VII. Executive Order 12866 and

Regulatory Flexibility Act

Section 1 of Executive Order 12866

requires that before promulgating a new

regulation, an agency must weigh many

competing factors. In particular, the

agency must assess the need for the

regulation, identify and assess

alternatives, determine whether the

regulation is designed to achieve the

agency’s objectives in the most costeffective manner, and, to the extent

feasible, use performance standards. In

addition, Section 5 of the Order requires

an assessment of the burden imposed by

existing regulations, to identify those

that have become unjustified or

unnecessary as a result of changed

circumstances. The Regulatory

Flexibility Act (the Act) also requires

that the agency periodically review

existing regulations and consider

reforming those that burden small

entities, taking into account the degree

to which technology or other factors

have changed in the area affected by the

rule. NIOSH is promulgating these

regulatory changes in compliance with

both sections of the Executive Order and

the Act.

Dose-response data are inadequate to

permit a quantitative description of the

risks that would be faced by American

workers if respirators were not used.

Neither are there dose-response data

that can support a quantitative

description of the risk reduction that

will be achieved by the revised filter

performance standards in 42 CFR part

84. Employers frequently lack the

economic means or the technical

expertise to make detailed workplace

hazard assessments. For the great

majority of occupational settings,

environmental data on the airborne

concentrations of toxic materials are

completely lacking. When exposure data

are available, they tend to be limited at

best. Consequently, it is difficult to

establish quantitative exposure-response

relationships. Most often, occupational

exposure data demonstrate the

association between exposure and

response, but do not support a precise

exposure-response curve. Extrapolation

from exposure to dose is subject to even

greater uncertainty. The variability in

exposure between and within

workplaces, exposures over long

working lifetimes, possibly inconsistent

or improper use of respiratory

protection, and undetected episodes of

substandard respirator performance,

among other factors, all make it very

difficult to determine what a worker’s

dose may be even if there are measured

exposure levels.

Employers, both large and small, rely

upon respirators to protect their

employees from airborne toxic

contaminants. The preferred and most

effective means of protecting workers is

to prevent hazards entering their

breathing zone in the first place, but it

is not technologically or economically

feasible in all instances to reduce

airborne concentrations to safe levels. In

those workplaces, respiratory protection

is required to minimize workers’ risks of

acute and chronic health effects.

Although the incremental risk reduction

associated with this rulemaking cannot

be quantified, it is evident that

increased filtering efficiency and

enhanced filter reliability must increase

the margin of safety for respirator users.

As the last, and occasionally the only,

defense against some acute and chronic

health hazards at work it is important

that respirators be reliable and that they

perform in the manner and to the extent

the user and employer expect. If

respirators fail to perform as expected,

the user will be at greatly increased risk

of suffering serious, sometimes fatal,
30352 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

occupational disease or injury. In most

circumstances the respirator user has no

way of knowing if respirator

performance is substandard. Except for

the most acute responses to substandard

respirator performance, it is not possible

to attribute health effects to a failure of

respiratory protection. Most of the

serious occupational diseases have long

latency periods, so respirator users

typically would not know if they used

an inferior device. Even the relationship

to workplace exposures can be obscured

because of the presumption that

respirators provide effective protection.

Respriator purchasers and users

expect and deserve to be able to select

respirators with complete confidence

that they will perform with a specific

efficiency for a specific purpose. They

rely on the NIOSH, formerly MSHA/

NIOSH, performance standards and

certification program to assure them that

they can have that confidence.

These new particulate filter efficiency

tests are needed to reduce potential

health risks that may result from leakage

of small particulates through some

filters certified under the current

regulations (30 CFR part 11). For over a

decade the filter penetration tests

contained in 30 CFR part 11 have been

known to be deficient. Leakage of small

aerosols has been recognized as a

problem that could be corrected only by

revising that regulation.

The magnitude of the filter leakage

problem came into sharper focus in the

early 1990’s when NIOSH and other

researchers used modern methods not

available under the provisions of part 11

to measure performance over a range of

particle sizes. For certain models,

leakages higher than 50% were found.

Not all respirator models exhibit this

high level of leakage, but 30 CFR part

11 testing does not distinguish adequate

from inadequate filters.

The respirator community

acknowledges filter leakage to be a

problem. The American National

Standards Institute (ANSI) Z88.2–1992

national standard, for example, states

that 2 of the 3 types of particulate

respirators certified under 30 CFR part

11 should be used only when the

workplace particulate contaminant is

know to have a mass median

aerodynamic diameter (MMAD) greater

that 2 micrometer.

Compliance with aerosol size

limitations such as those of the ANSI

Z88.2 would represent a major

technologic and economic burden for

respirator users. Those burdens are great

even for the largest employers and

exceed the capacity of smaller

employers. Adequate worker protection

with DM and DFM respirators certified

under 30 CFR part 11 can be assured

only if employers conduct sophisticated

and expensive measurements of the size

distribution of the aerosol in each

workplace. This is simply too expensive

for the great majority of respirator users,

who may elect to use DM or DFM

respirators without evaluating aerosols

in their workplaces, thereby placing

their workers at increased risk of

occupational disease or disability. The

only alternative at present is for those

employers to provide costly high

efficiency (HEPA) filters. The difficult

and costly aerosol size measurements

are not needed when HEPA filters are

used because they are tested with the

most penetrating size of aerosol. HEPA

filters are therefore known to be

effective against any aerosol regardless

of size.

The new 42 CFR part 84 filter

efficiency tests use only the most

penetrating aerosol size, so all filters

certified under these new procedures

will be effective against any size aerosol.

This new rule thereby corrects an

acknowledged deficiency in existing

filter efficiency tests, removes from the

workplace respirators that fail to deliver

the expected degree of worker

protection, relieves employers of the

need to perform costly and difficult

measurements of aerosol size

distribution, and provides alternatives

to the expensive HEPA filters in

workplaces where the aerosol size is

either unknown or is known to be small.

This new rule continues to limit, as

does the current 30 CFR part 11, the

breathing resistance (inhalation and

exhalation resistance) of the respirator.

Breathing resistance is significant to

respirator wearers in three ways. First,

higher breathing resistance increases

leakage at the face seal of the respirator.

Face seal leakage is directly

proportional to breathing resistance,

other factors being equal. Second,

respirators with lower breathing

resistance are more comfortable and

more acceptable to wearers. If a

respirator is uncomfortable to wear,

workers are less inclined to use their

respirator as often as they should. Third,

high breathing resistance can be an

unacceptable physiological burden on

some workers. For a worker with

impaired pulmonary or cardiovascular

function, high breathing resistance may

make respirator use impossible. In this

rule, NIOSH has increased the allowable

inhalation and exhalation resistance in

consideration of minimizing economic

impact, but NIOSH has maintained the

breathing resistance at a level that still

will minimize adverse impacts on the

respirator user.

E.O. 12866 further requires the agency

to determine whether the proposed rule

is ‘‘economically significant’’ (e.g., it

does not have an annual effect on the

economy of $100 million). NIOSH

generally prepares a regulatory

flexibility analysis, in accordance with

the Act, if the rule is expected to have

a significant impact on a substantial

number of small entities. NIOSH does

not believe that this final rule will have

an annual impact on the economy of

$100 million, nor does NIOSH believe

that the rule will have a significant

impact on a substantial number of small

firms.

This regulatory change affects only

particulate respirators. A total of 56

manufacturers hold respirator

approvals, and 33 of these hold

approvals for particulate respirators.

Based on inquiries received, NIOSH

believes that several additional

manufacturers are planning to submit

applications for particulate filter

products under this new regulation.

Data are not available to define

company size, market share, or diversity

of products for the current approvalholders. Projections of impact are based

on an understanding of manufacturers—

dependence on existing approved

particulate respirators. Of the 33

manufacturers that have particulate filer

approvals, 24 hold additional approvals

for devices other than particulate

respirators, and nine have only

particulate filter approvals. One of these

manufacturer holds approvals for DM,

DFM and HEPA respirators, while the

remaining eight each hold only a single

particulate filter approval. Because all

existing HEPA filters are expected to

pass the new certification tests, it

appears that only eight of 56 respirator

manufacturers might be dependent

upon particulate filter respirators

possibly at risk of not passing the new

certification tests without redesign. At

least one of these eight manufacturers

commented favorably on this proposed

rule, indicating readiness to meet these

new criteria.

Any manufacturer that cannot meet

the new criteria immediately will have

three years in which to develop new

products or face removal from the

approved respirator market. However,

loss of approved respirator status does

not prohibit sales of the devices as nonapproved units. The non-approved

respirator market appears to be very

lucrative, with several of the larger

manufacturers participating. Nonapproved respirators are sold in many

retail outlets including hardware, auto

supply, and department stores.

Consumers purchase these devices for

use against nuisance dusts while
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30353

performing various home and hobbyrelated activities.

While some current respirator

manufacturers may experience negative

impacts, other manufacturers that are

not now approval holders have

indicated an intention to enter this

market. The new rule thus will

stimulate competition as new

technologies are introduced and new

markets are developed. Furthermore,

this rule enhances the ability of

domestic manufacturers to compete

globally, especially in the European

Community. NIOSH expects to see more

new approval holders develop as a

result of the new rule.

A high percentage of the respirator

manufacturers are large corporations or

subsidiaries and are international in

nature, although several employ 100 or

fewer persons. NIOSH does not have an

estimate of the total number employed

by the 33 manufacturers of particulate

respirators. Neither does NIOSH have

any indication of how many employees

are engaged solely in the manufacture of

particulate respirators. However, the

respirator manufacturing industry in

general is mature and stable. A 1982

survey of the industry performed for

NIOSH covered 29 firms that were

active at that time, the majority of which

continue to manufacture respirators in

1995. Of these, 12 were subsidiaries of

larger firms. Median total employment

was 375. A large portion of these

workers were believed to be engaged in

activities unrelated to particulate

respirator manufacturing. Sales figures

indicated respirator sales ranged from

less than 1% to 10–15% of total

corporate sales.

NIOSH believes the industry profile

remains basically the same it was in

1982. That is, respirators do not

represent the primary source of sales

income for any of the manufacturers

that will be affected. Because respirators

represent a low percentage of overall

sales, the percentage of total employees

involved in the manufacture of

respirators is believed also to be low.

Therefore, few employees are likely to

be severely impacted by the new rule.

Indeed, the increased competition and

opening of markets expected to result

from the rule may well enhance

aggregate employment for both current

and new approval holders.

Most employers rely on government

standards to determine acceptable levels

of respirator performance. It would be

inefficient and unreasonably costly for

each of millions of occasional

purchasers of these inexpensive devices

to independently attempt to determine

which devices operate effectively to

filter out submicron toxic particles.

This rule removes a regulatory

impediment to the improved design of

respirators by substituting a

performance standard for an obsolete

specifications standard. The practical

effect of this will be to enable firms to

substitute a more effective and efficient

filter material in lower-cost respirators.

Respirators already using high

efficiency filters meeting 30 CFR part 11

requirements will not be affected by this

proposal. These respirators will not

require modification to be certified

under this final rule, although the

certification may not be at the new P100

efficiency level. Although the category

of performance may be reduced from the

previous HEPA rating, no design or

development costs are associated with

the certification of these products.

NIOSH received limited responses to

its request for comments and data for

projected estimates of cost for materials

and labor for these improved

respirators. Several respirator

manufacturers referred to a survey

conducted by their trade association as

suggesting that costs of this module

would exceed $100 million, but specific

cost estimates for this module were not

provided. The trade association reported

that their estimate was based largely on

the surveyed manufacturers’ projections

of procuring new equipment, procuring

new materials, plant retooling, and the

like. The largest manufacturer of

respirators did not project the same cost

impact on its products, even though that

manufacturer recommended changing

the proposed rule to eliminate the least

costly class of proposed respirators and

to increase the severity of two testing

parameters. Another manufacturer

stated that the ‘‘projected increased user

cost for disposables of 42 CFR part 84

would be between $440 and $990

million,’’ based solely on impacts to that

manufacturer’s products. This

manufacturer forecast that prices to end

users would rise by 1.7- to 2.9-fold or

9- to 16-fold depending on filter type.

Very limited data were submitted in

support of any of these estimates, but it

appears that the large discrepancy

between NIOSH and industry cost

estimates are attributable to 3 principal

factors:

(1) Cost estimates by industry

included many capital investmet costs

rather than recurring annual costs,

inclusion of which improperly inflated

the annual cost projections.

(2) An erroneous assumption made by

the manufacturer projecting the greatest

cost impact. That manufacturer assumed

that the proposed fit test would require

all disposable respirators to have an

elastomeric flange. Additional costs

attributed to consumer reaction to this

assumption were:

(a) expensive reusable elastomeric

cartridge respirators replacing

inexpensive disposable models, and

(b) costly respirator maintenance and

training programs associated with

reusable respirators.

Neither NIOSH nor other

manufacturers projected either of these

as a consequence of the fit testing. In

any event, the requirement for fit testing

was eliminated from the final rule. That

represents a cost saving in itself but this

change also renders moot the question

of elastomeric flanges for disposable

respirators.

(3) Two additional elements of the

proposed rule were identified as having

significant cost impact: statistical

evaluation of certification test results

and limitations on inhalation/exhalation

resistance. These were changed in the

final rule to eliminate the statistical

criterion and to adopt the inhalation/

exhalation resistance levels requested

by the manufacturers. As a result and as

discussed below under specific topics,

NIOSH does not believe that this rule

will approach the $100 million

threshold. In fact, NIOSH believes that

over time manufacturers’ costs and

prices to users will fall.

Commenters stated that the statistical

treatment of test data as included in the

proposal would ‘‘add greatly to the cost

of filters and respirators.’’ One

commenter estimated that the added

manufacturing and waste costs

attributable to this provision would be

25–30% of the costs attributable to the

proposal. According to the commenters,

the replacement of the proposed

statistical treatment of test data with the

less stringent statistical treatment

proposed by NIOSH in 1987 or a pass/

fail criterion would remove the added

cost implications of the proposed rule.

As discussed previously, NIOSH has

replaced the proposed requirement for

the statistical treatment of test data with

the recommended pass-fail criterion.

Twenty filters are to be tested, reduced

from 30 to be required under the

proposal. This change in the final rule,

based on technical concerns discussed

previously, will significantly reduce the

cost implications of the final rule from

the estimated costs of the proposal.

The fit test requirements proposed

under §§ 84.181 and 84.182 were

identified as another source of a

significant portion of the costs

attributed to the proposed rule. The

increased costs resulted from the

interpretation that the isoamyl acetate

testing would necessitate elastomeric

inner flanges to be added to all certified

disposable respirators in all categories.
30354 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

This interpretation led to two

conclusions that increased the cost

estimates. The first conclusion was that

all disposable filter respirators would

need to be redesigned to include a

costly elastomeric facepiece. The

estimated increased costs of disposable

respirators led to the second conclusion

that the currently inexpensive and

widely used disposable particulate

respirators would be replaced by costly

reusable elastomeric cartridge masks.

This increased use of reusable masks

was estimated to increase users’ costs of

respirator maintenance and training

programs not associated with disposable

respirators. The costs associated with

the use of an isoamyl acetate

represented a substantial portion of the

projected cost impact of the proposed

rule.

As discussed earlier, NIOSH has

reconsidered the proposed requirement

for isoamyl acetate fit-testing of these

respirators. Based on technical

considerations, the isoamyl acetate tests

have not been included in the final rule.

NIOSH anticipates that currently

accepted, fit-testing procedures will

continue to be used to assure a proper

respirator-to-face seal for each respirator

user. Based on prior experience with

currently certified disposable respirators

using these procedures, no redesign of

the facepiece seal of disposable

respirators will be required as a result

of this final rule. Therefore, the cost

implications attributed to the isoamyl

acetate fit tests are not applicable to this

final rule.

It is our understanding that

substituting better filter material will

have negligible effects on the costs of

filters, over the long run. The material

costs may be slightly increased, but are

relatively small compared to those

estimates for statistical evaluation and

fit testing. The costs associated with

these latter two have been greatly

reduced by the requirements in the final

rule.

The demonstrated level of

performance for filters will be

substantially more effective. Instead of

an efficiency rate of 95 percent for

removing particles sized at 1 to 2

micrometers in diameter, they will

demonstrate the ability to remove

particles of less than 1 micrometer in

diameter at a typical efficiency rate of

95 to 99.97 percent. The importance of

this change will vary considerably from

workplace setting to setting. However,

in at least some settings the benefits will

be considerable.

For example, the classes of particulate

filter respirators certified under this rule

will meet or exceed the

recommendations for respiratory

protective devices used for M.

tuberculosis. Of the currently NIOSHcertified respirators, only highefficiency particulate air (HEPA) filters

meet or exceed these recommendations.

The certification to an enhanced

performance level will create options for

the choice of respirators that adhere to

the recommendations at reduced

expense. A disposable (one-time use)

HEPA filter respirator generally sells for

around $7 to $10 and replaceable

respirators equipped with HEPA filters

can cost $20 or more, with replacement

filters costing about $5 each.

Replacement non-HEPA filters cost

about $1 to $2 each. Disposable nonHEPA filters cost about $1 to $8 each

when purchased in bulk. Costs for a N95

filter are expected to be less than those

of a current HEPA filter. Applications of

new filter technologies and market

competition is expected to generally

have the impact of reducing the cost of

the new respirators. At least one

commenter has already indicated that

the 95% efficiency level respirators will

be priced not exceeding the cost of 30

CFR part 11 disposable DFM respirators,

$5 to $8 each.

NIOSH would expect similar effects—

both improved health and cost

avoidance—in many other settings.

NIOSH estimates that as many as seven

million workers use respirators at some

time each year. NIOSH estimates that

employers annually purchase over 110

million disposable respirators.

There are approximately 35

manufacturers of these respiratory

devices. Most of these already possess

or have access to test equipment needed

to perform the new filter tests. As is

currently required under 30 CFR part

11, NIOSH will continue to require that

applicants conduct or have conducted

examinations, inspections, and tests of

respirator performance at least

equivalent to those set by the respirator

certification tests. This is to assure that

all necessary research and development

is conducted by the applicant prior to

submitting an application to the Federal

Government for testing of the respirator

by NIOSH. For those manufacturers that

do not currently possess this capability,

NIOSH estimates that the purchase of

this equipment represents an

investment of approximately $60,000.

Amortized over time, this would not

represent a significant cost for most

manufacturers.

Commenters indicated that the

projected costs of new, updated test

instruments for the filter efficiency

testing contributed significantly to the

costs reported to be attributable to the

proposed rule. NIOSH agrees that if

manufacturers opt to purchase newly

developed instruments, this represents a

significant investment. As discussed

previously, the filter efficiency tests of

this final rule can be conducted using

the instrumentation previously

specified for the testing of high

efficiency filters under 30 CFR part 11.

Therefore, the purchase of new test

instruments is not required for most

manufacturers. Further, the purchase of

test instruments represents a capital

investment amortized over time, not an

annual recurring cost.

Filter materials are currently available

that can be substituted into present filter

designs with minimal redesign (if any)

to meet the performance requirements of

the new tests. Some currently NIOSHcertified respirators have, when tested

using the new standards, demonstrated

acceptable performance. Therefore, little

or no cost will be needed to develop

suitable filtration materials or redesign

existing devices. However, NIOSH does

realize that additional development and

redesign costs may be incurred to

augment the presently available

products. NIOSH specifically requested

relevant data and comments on

projected costs of redesign of

respirators.

One commenter cited the cost of

commercially available filter media to

meet the proposed standards as

dramatically increased over the present

cost of the existing 30 CFR part 11

disposable dust/mist requirements. The

cost of present dust/mist media was

stated as between 60 cents and one

dollar per square yard, whereas the cost

of commercially available filter media to

meet the proposed 42 CFR part 84

requirements is between 12 dollars and

17 dollars per square yard, depending

on the type (A, B, or C), and whether it

is for the ‘‘solids’’ or ‘‘liquid/solids’’

category. Two other commenters

indicated the availability of prototype

respirators and filters that could be

marketed for little or no cost increase

from existing dust/fume/mist respirators

and filters.

Several comments were received

stating that the combination of proposed

initial inhalation and exhalation

resistance limits and efficiency levels

might require increasing the surface area

of filters. It was asserted that an increase

in filter surface area to meet these

requirements would ‘‘increase

substantially the raw material and

manufacturing costs of respirator

protection.’’ For the technical reasons

discussed previously, the initial

inhalation and exhalation resistances

have been increased in the final rule to

the values recommended by these

commenters. Adoption of these values

will allow ‘‘latitude to develop filters at
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30355

a reasonable cost without compromising

safety or comfort to the user,’’ according

to the comments.

In summary, NIOSH did not believe

the proposed rule change was

‘‘economically significant’’ within the

definition of E.O. 12866 based on the

cost projections attributable to the

proposal that were provided to NIOSH

and those modifications incorporated

into the final rule.

Notwithstanding these general

conclusions, there may be some

manufacturers that will find it

financially difficult, or a poor

investment, to meet the new standards.

NIOSH expects such problems to result

from free market competition rather

than the specific standards of these final

regulations. That is, most

knowledgeable employers would

purchase more cost-effective respirators

voluntarily and force major changes in

the market if the present regulatory

barriers were removed.

List of Subjects in 42 CFR Part 84

Administrative practice and

procedure, Incorporation by reference,

Labeling, Mine safety and health,

Occupational safety and health,

Personal protective equipment,

Reporting and recordkeeping

requirements, Respirators.

Dated: April 14, 1995.

Philip R. Lee,

Assistant Secretary for Health.

Dated: April 14, 1995.

Donna E. Shalala,

Secretary.

For the reasons set out in the

preamble, 42 CFR part 84 is added to

read as follows:

PART 84—APPROVAL OF

RESPIRATORY PROTECTIVE DEVICES

Subpart A—General Provisions

Sec.

84.1 Purpose.

84.2 Definitions.

84.3 Respirators for mine rescue or other

emergency use in mines.

Subpart B—Application for Approval

84.10 Application procedures.

84.11 Contents of application.

84.12 Delivery of respirators and

components by applicant; requirements.

Subpart C—Fees

84.20 Examination, inspection, and testing

of complete respirator assemblies; fees.

84.21 Examination, inspection, and testing

of respirator components or

subassemblies; fees.

84.22 Unlisted fees; additional fees;

payment by applicant prior to approval.

Subpart D—Approval and Disapproval

84.30 Certificates of approval; scope of

approval.

84.31 Certificates of approval; contents.

84.32 Notice of disapproval.

84.33 Approval labels and markings;

approval of contents; use.

84.34 Revocation of certificates of approval.

84.35 Changes or modifications of approved

respirators; issuance of modification of

certificate of approval.

84.36 Delivery of changed or modified

approved respirator.

Subpart E—Quality Control

84.40 Quality control plans; filing

requirements.

84.41 Quality control plans; contents.

84.42 Proposed quality control plans;

approval by the Institute.

84.43 Quality control records; review by the

Institute; revocation of approval.

Subpart F—Classification of Approved

Respirators; Scope of Approval;

Atmospheric Hazards; Service Time

84.50 Types of respirators to be approved;

scope of approval.

84.51 Entry and escape, or escape only;

classification.

84.52 Respiratory hazards; classification.

84.53 Service time; classification.

Subpart G—General Construction and

Performance Requirements

84.60 Construction and performance

requirements; general.

84.61 General construction requirements.

84.62 Component parts; minimum

requirements.

84.63 Test requirements; general.

84.64 Pretesting by applicant; approval of

test methods.

84.65 Conduct of examinations,

inspections, and tests by the Institute;

assistance by applicant; observers;

recorded data; public demonstrations.

84.66 Withdrawal of applications; refund of

fees.

Subpart H—Self-Contained Breathing

Apparatus

84.70 Self-contained breathing apparatus;

description.

84.71 Self-contained breathing apparatus;

required components.

84.72 Breathing tubes; minimum

requirements.

84.73 Harnesses; installation and

construction; minimum requirements.

84.74 Apparatus containers; minimum

requirements.

84.75 Half-mask facepieces, full facepieces,

mouthpieces; fit; minimum

requirements.

84.76 Facepieces; eyepieces; minimum

requirements.

84.77 Inhalation and exhalation valves;

minimum requirements.

84.78 Head harnesses; minimum

requirements.

84.79 Breathing gas; minimum

requirements.

84.80 Interchangeability of oxygen and air

prohibited.

84.81 Compressed breathing gas and

liquefied breathing gas containers;

minimum requirements.

84.82 Gas pressure gages; minimum

requirements.

84.83 Timers; elapsed time indicators;

remaining service life indicators;

minimum requirements.

84.84 Hand-operated valves; minimum

requirements.

84.85 Breathing bags; minimum

requirements.

84.86 Component parts exposed to oxygen

pressures; minimum requirements.

84.87 Compressed gas filters; minimum

requirements.

84.88 Breathing-bag test.

84.89 Weight requirement.

84.90 Breathing resistance test; inhalation.

84.91 Breathing resistance test; exhalation.

84.92 Exhalation valve leakage test.

84.93 Gas flow test; open circuit apparatus.

84.94 Gas flow test; closed circuit

apparatus.

84.95 Service-time test; open circuit

apparatus.

84.96 Service-time test; closed circuit

apparatus.

84.97 Test for carbon dioxide in inspired

gas; open- and closed-circuit apparatus;

maximum allowable limits.

84.98 Tests during low temperature

operation.

84.99 Man tests; testing conditions; general

requirements.

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

requirements.

84.101 Man test 5; requirements.

84.102 Man test 6; requirements.

84.103 Man tests; performance

requirements.

84.104 Gas tightness test; minimum

requirements.

Tables to Subpart H of Part 84

Subpart I—Gas Masks

84.110 Gas masks; description.

84.111 Gas masks; required components.

84.112 Canisters and cartridges in parallel;

resistance requirements.

84.113 Canisters and cartridges; color and

markings; requirements.

84.114 Filters used with canisters and

cartridges; location; replacement.

84.115 Breathing tubes; minimum

requirements.

84.116 Harnesses; installation and

construction; minimum requirements.

84.117 Gas mask containers; minimum

requirements.

84.118 Half-mask facepieces, full

facepieces, and mouthpieces; fit;

minimum requirements.

84.119 Facepieces; eyepieces; minimum

requirements.

84.120 Inhalation and exhalation valves;

minimum requirements.

84.121 Head harnesses; minimum

requirements.

84.122 Breathing resistance test; minimum

requirements.

84.123 Exhalation valve leakage test.

84.124 Facepiece tests; minimum

requirements.
30356 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

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; suppliedair respirators; minimum requirements.

84.140 Air velocity and noise levels; hoods

and helmets; minimum requirements.

84.141 Breathing gas; minimum

requirements.

84.142 Air supply source; hand-operated or

motor driven air blowers; Type A

supplied-air respirators; minimum

requirements.

84.143 Terminal fittings or chambers; Type

B supplied-air respirators; minimum

requirements.

84.144 Hand-operated blower test;

minimum requirements.

84.145 Motor-operated blower test;

minimum requirements.

84.146 Method of measuring the power and

torque required to operate blowers.

84.147 Type B supplied-air respirator;

minimum requirements.

84.148 Type C supplied-air respirator,

continuous-flow class; minimum

requirements.

84.149 Type C supplied-air respirator,

demand and pressure demand class;

minimum requirements.

84.150 Air-supply line tests; minimum

requirements.

84.151 Harness test; minimum

requirements.

84.152 Breathing tube test; minimum

requirements.

84.153 Airflow resistance test, Type A and

Type AE supplied-air respirators;

minimum requirements.

84.154 Airflow resistance test; Type B and

Type BE supplied-air respirators;

minimum requirements.

84.155 Airflow resistance test; Type C

supplied-air respirator, continuous flow

class and Type CE supplied-air

respirator; minimum requirements.

84.156 Airflow resistance test; Type C

supplied-air respirator, demand class;

minimum requirements.

84.157 Airflow resistance test; Type C

supplied-air respirator, pressure-demand

class; minimum requirements.

84.158 Exhalation valve leakage test.

84.159 Man tests for gases and vapors;

supplied-air respirators; general

performance requirements.

84.160 Man tests for gases and vapors; Type

A and Type AE respirators; test

requirements.

84.161 Man tests for gases and vapors; Type

B and Type BE respirators; test

requirements.

84.162 Man test for gases and vapors; Type

C respirators, continuous-flow class and

Type CE supplied-air respirators; test

requirements.

84.163 Man test for gases and vapors; Type

C supplied-air respirators, demand and

pressure-demand classes; test

requirements.

Tables to Subpart J of Part 84

Subpart K—Non-Powered Air-Purifying

Particulate Respirators

84.170 Non-powered air-purifying

particulate respirators; description.

84.171 Non-powered air-purifying

particulate respirators; required

components.

84.172 Breathing tubes; minimum

requirements.

84.173 Harnesses; installation and

construction; minimum requirements.

84.174 Respirator containers; minimum

requirements.

84.175 Half-mask facepieces, full facepieces,

hoods, helmets, and mouthpieces; fit;

minimum requirements.

84.176 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

84.177 Inhalation and exhalation valves;

minimum requirements.

84.178 Head harnesses; minimum

requirements.

84.179 Non-powered air-purifying

particulate respirators; filter

identification.

84.180 Airflow resistance tests.

84.181 Non-powered air-purifying

particulate filter efficiency level

determination.

84.182 Exhalation valve leakage test;

minimum requirements.

Subpart L—Chemical Cartridge Respirators

84.190 Chemical cartridge respirators;

description.

84.191 Chemical cartridge respirators;

required components.

84.192 Cartridges in parallel; resistance

requirements.

84.193 Cartridges; color and markings;

requirements.

84.194 Filters used with chemical

cartridges; location; replacement.

84.195 Breathing tubes; minimum

requirements.

84.196 Harnesses; installation and

construction; minimum requirements.

84.197 Respirator containers; minimum

requirements.

84.198 Half-mask facepieces, full

facepieces, mouthpieces, hoods, and

helmets; fit; minimum requirements.

84.199 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

84.200 Inhalation and exhalation valves;

minimum requirements.

84.201 Head harnesses; minimum

requirements.

84.202 Air velocity and noise levels; hoods

and helmets; minimum requirements.

84.203 Breathing resistance test; minimum

requirements.

84.204 Exhalation valve leakage test;

minimum requirements.

84.205 Facepiece test; minimum

requirements.

84.206 Particulate tests; respirators with

filters; minimum requirements; general.

84.207 Bench tests; gas and vapor tests;

minimum requirements; general.

Tables to Subpart L of Part 84

Subpart M—[Reserved]

Subpart N—Special Use Respirators

84.250 Vinyl chloride respirators;

description.

84.251 Required components.

84.252 Gas masks; requirements and tests.

84.253 Chemical-cartridge respirators;

requirements and tests.

84.254 Powered air-purifying respirators;

requirements and tests.

84.255 Requirements for end-of-service-life

indicator.

84.256 Quality control requirements.

84.257 Labeling requirements.

84.258 Fees.

Subparts O through JJ [Reserved]

Subpart KK—Dust, Fume, and Mist;

Pesticide; Paint Spray; Powered AirPurifying High Efficiency Respirators and

Combination Gas Masks

84.1100 Scope and effective dates.

84.1101 Definitions.

84.1102 Examination, inspection and

testing of complete respirator assemblies;

fees.

84.1103 Approval labels and markings;

approval of contents; use.

84.1130 Respirators; description.

84.1131 Respirators; required components.

84.1132 Breathing tubes; minimum

requirements.

84.1133 Harnesses; installation and

construction; minimum requirements.

84.1134 Respirator containers; minimum

requirements.

84.1135 Half-mask facepieces, full

facepieces, hoods, helmets, and

mouthpieces; fit; minimum

requirements.

84.1136 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

84.1137 Inhalation and exhalation valves;

minimum requirements.

84.1138 Head harnesses; minimum

requirements.

84.1139 Air velocity and noise levels;

hoods and helmets; minimum

requirements.

84.1140 Dust, fume, and mist respirators;

performance requirements; general.

84.1141 Isoamyl acetate tightness test; dust,

fume, and mist respirators designed for

respiratory protection against fumes of

various metals having an air

contamination level not less than 0.05

milligram per cubic meter; minimum

requirements.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30357

84.1142 Isoamyl acetate tightness test;

respirators designed for respiratory

protection against dusts, fumes, and

mists having an air contamination level

less than 0.05 milligram per cubic meter,

or against radionuclides; minimum

requirements.

84.1143 Dust, fume, and mist air-purifying

filter tests; performance requirements;

general.

84.1144 Silica dust test for dust, fume, and

mist respirators; single-use or reusable

filters; minimum requirements.

84.1145 Silica dust test; non-powered

single-use dust respirators; minimum

requirements.

84.1146 Lead fume test for dust, fume, and

mist respirators; minimum requirements.

84.1147 Silica mist test for dust, fume, and

mist respirators; minimum requirements.

84.1148 Tests for respirators designed for

respiratory protection against more than

one type of dispersoid; minimum

requirements.

84.1149 Airflow resistance tests; all dust,

fume, and mist respirators; minimum

requirements.

84.1150 Exhalation valve leakage test;

minimum requirements.

84.1151 DOP filter test; respirators designed

as respiratory protection against dusts,

fumes, and mists having an air

contamination level less than 0.05

milligram per cubic meter and against

radionuclides; minimum requirements.

84.1152 Silica dust loading test; respirators

designed as protection against dusts,

fumes, and mists having an air

contamination level less than 0.05

milligram per cubic meter and against

radionuclides; minimum requirements.

84.1153 Dust, fume, mist, and smoke tests;

canister bench tests; gas mask canisters

containing filters; minimum

requirements.

84.1154 Canister and cartridge

requirements.

84.1155 Filters used with canisters and

cartridges; location; replacement.

84.1156 Pesticide respirators; performance

requirements; general.

84.1157 Chemical cartridge respirators with

particulate filters; performance

requirements; general.

84.1158 Dust, fume, and mist tests;

respirators with filters; minimum

requirements; general.

Tables to Subpart KK of Part 84

Authority: 29 U.S.C. 577a, 651 et seq., and

657(g); 30 U.S.C. 3, 5, 7, 811, 842(h), 844.

Subpart A—General Provisions

§ 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.

§ 84.2 Definitions.

As used in this part—

(a) Applicant means an individual,

partnership, company, corporation,

association, or other organization that

designs, manufactures, assembles, or

controls the assembly of a respirator and

who seeks to obtain a certificate of

approval for such respirator.

(b) Approval means a certificate or

formal document issued by the Institute

stating that an individual respirator or

combination of respirators has met the

minimum requirements of this part, and

that the applicant is authorized to use

and attach an approval label to any

respirator, respirator container, or

instruction card for any respirator

manufactured or assembled in

conformance with the plans and

specifications upon which the approval

was based, as evidence of such

approval.

(c) Approved means conforming to the

minimum requirements of this part.

(d) Auxiliary equipment means a selfcontained breathing apparatus, the use

of which is limited in underground

mine rescue and recovery operations to

situations where the wearer has ready

access to fresh air and at least one crew

equipped with approved self-contained

breathing apparatus of 2 hours or longer

rating, is in reserve at a fresh-air base.

(e) Certification and Quality

Assurance Branch means the

Certification and Quality Assurance

Branch, Division of Safety Research,

Appalachian Laboratory for

Occupational Safety and Health,

National Institute for Occupational

Safety and Health, 1095 Willowdale

Road, Morgantown, West Virginia

26505–2888.

(f) Compressed-breathing gas means

oxygen or air stored in a compressed

state and supplied to the wearer in

gaseous form.

(g) dBA means sound pressure levels

in decibels, as measured with the Aweighted 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
30358 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

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.

§ 84.3 Respirators for mine rescue or other

emergency use in mines.

(a)(1) NIOSH and the Mine Safety and

Health Administration (MSHA), U.S.

Department of Labor, shall jointly

review and issue certifications for

respirators used for mine emergencies

and mine rescue, including any

associated service-life plans, users’

manuals and other supporting

documentation.

(2) Each certification for a respirator

designed for mine rescue or other

emergency use in mines shall include,

as a condition of approval, any use

limitations related to mine safety and

health.

(b) NIOSH and MSHA shall jointly

determine appropriate recall and retrofit

remedies for field complaints or

identified deficiencies involving any

respirators used in the mining

environment.

Subpart B—Application for Approval

§ 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 § 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.

§ 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 § 84.64, and shall include the results

of such tests.

(e) Each application for approval shall

contain a statement that the respirator

and component parts submitted for

approval are either prototypes, or made

on regular production tooling, with no

operation included which will not be

incorporated in regular production

processing.

(The information collections

contained in this section are approved

under OMB control number 0920–0109)

§ 84.12 Delivery of respirators and

components by applicant; requirements.

(a) Each applicant shall, when an

application is filed pursuant to § 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

§ 84.20 Examination, inspection, and

testing of complete respirator assemblies;

fees.

Except as provided in § 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
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30359

Entry and escape, less than 1

hour ........................................... 2,750

Escape only .................................. 2,000

Gas masks:

Single hazard ................................ 1,100

Type N .......................................... 4,100

Supplied-air respirators .................. 750

Particulate respirators ..................... 1,250

Chemical cartridge respirators ........ 1,150

§ 84.21 Examination, inspection, and

testing of respirator components or

subassemblies; fees.

Except as provided in § 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

§ 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 § 84.20, or for the examination,

inspection, and testing of respirator

components or subassemblies which are

not listed in § 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 manday 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

§ 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

§ 84.11, states that the submitted

respirator and component parts are only

prototypes, the Institute will examine,

inspect, and test such respirator and

component parts in accordance with the

provisions of this part. If, upon

completion of such examinations,

inspections and tests, it is found that the

prototype meets the minimum

requirements set forth in this part, the

Institute may inform the applicant, in

writing, of the results of the

examinations, inspections, and tests,

and may require him to resubmit

respirators and component parts made

on regular production tooling, with no

operations included which will not be

incorporated in regular production

processing, for further examination,

inspection, and testing, prior to issuance

of the certificate of approval.

(d) Applicants required to resubmit

respirators and component parts made

on regular production tooling, with no

operation included which will not be

incorporated in regular production

processing, shall be charged fees in

accordance with subpart C of this part.

§ 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 § 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

§ 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 § 84.42.

§ 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.

§ 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
30360 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

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 breathing apparatus Entire .............................................. Harness assembly and canister (where applicable).

Gas mask ....................................... Entire .............................................. Mask container and canister.

Supplied air respirator .................... ......do ............................................. Respirator container or instruction card.

Particulate respirator ...................... ......do ............................................. Respirator container and filter container.

Abbreviated .................................... Filters.

Chemical-cartridge respirator ......... Entire .............................................. Respirator container, 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.

§ 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.

§ 84.35 Changes or modifications of

approved respirators; issuance of

modification of certificate of approval.

(a) Each applicant may, if he desires

to change any feature of an approved

respirator, request a modification of the

original certificate of approval issued by

the Institute for such respirator by filing

an application for such modification in

accordance with the provisions of this

section.

(b) Applications shall be submitted as

for an original certificate of approval,

with a request for a modification of the

existing certificate to cover any

proposed change.

(c) The application shall be

accompanied by appropriate drawings

and specifications, and by a proposed

quality control plan which meets the

requirements of subpart E of this part.

(d) The application for modification,

together with the accompanying

material, shall be examined by the

Institute to determine whether testing

will be required.

(e) The Institute shall inform the

applicant of the fee required for any

additional testing and the applicant will

be charged for the actual cost of any

examination, inspection, or test

required, and such fees shall be

submitted in accordance with the

provisions of subpart C of this part.

(f) If the proposed change or

modification meets the requirements of

this part, a formal certificate of

modification will be issued,

accompanied, where necessary, by a list

of new and revised drawings and

specifications covering the change(s)

and reproductions of revised approval

labels.

(The information collections

contained in this section are approved

under OMB control number 0920–0109.)

§ 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

§ 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.

§ 84.41 Quality control plans; contents.

(a) Each quality control plan shall

contain provisions for the management

of quality, including:

(1) Requirements for the production of

quality data and the use of quality

control records;

(2) Control of engineering drawings,

documentations, and changes;

(3) Control and calibration of

measuring and test equipment;

(4) Control of purchased material to

include incoming inspection;

(5) Lot identification, control of

processes, manufacturing, fabrication,

and assembly work conducted in the

applicant’s plant;

(6) Audit of final inspection of the

completed product; and

(7) The organizational structure

necessary to carry out these provisions.

(b) Each provision for incoming and

final inspection in the quality control

plan shall include a procedure for the

selection of a sample of respirators and

the components thereof for testing, in

accordance with procedures set forth in

Military Standard MIL–STD–414, 11

June 1957, including Change Notice No.

1, ‘‘Sampling Procedures and Tables for

Inspection by Variables for Percent

Defective,’’ or an approved equivalent

sampling procedure, or an approved
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30361

combination of sampling procedures.

The procedure of Military Standard

MIL–STD–105D, 29 April 1963,

‘‘Sampling Procedures and Tables for

Inspection by Attributes,’’ is an example

of an equivalent sampling procedure.

MIL–STD–414 is incorporated by

reference and has been approved by the

Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained

from DODSSP, Standardization

Document Order Desk, 700 Robbins

Avenue, Bldg. 4D, Philadelphia, PA

19111–5094. Copies may be inspected at

the NIOSH, Certification and Quality

Assurance Branch, 1095 Willowdale

Road, Morgantown, WV 26505–2888, or

at the Office of the Federal Register, 800

North Capitol Street NW., suite 700,

Washington, DC. Copies of MIL–STD–

105D may be inspected or obtained from

the NIOSH, Certification and Quality

Assurance Branch, 1095 Willowdale

Road, Morgantown, WV 26505–2888.

Incoming bulk raw material inspection

or verification of specification, and inprocess inspection shall be sufficient to

ensure control of product quality

through the manufacturing cycle.

(c) The sampling procedure shall

include a list of the characteristics to be

tested by the applicant or his agent.

(d) The characteristics listed in

accordance with paragraph (c) of this

section shall be classified according to

the potential effect of such defect and

grouped into the following classes:

(1) Critical. A defect that judgment

and experience indicate is likely to

result in a condition immediately

hazardous to life or health for

individuals using or depending upon

the respirator;

(2) Major A. A defect, other than

critical, that is likely to result in failure

to the degree that the respirator does not

provide any respiratory protection, or a

defect that reduces protection and is not

detectable by the user;

(3) Major B. A defect, other than Major

A or critical, that is likely to result in

reduced respiratory protection, and is

detectable by the user; and

(4) Minor. A defect that is not likely

to materially reduce the usability of the

respirator for its intended purpose, or a

defect that is a departure from

established standards and has little

bearing on the effective use or operation

of the respirator.

(e) The quality control inspection test

method to be used by the applicant or

his agent for each characteristic required

to be tested shall be described in detail.

(f) Each item manufactured shall be

100 percent inspected for defects in all

critical characteristics and all defective

items shall be rejected.

(g) The Acceptable Quality Level

(AQL) for each major or minor defect so

classified by the applicant shall be:

(1) Major A. 1.0 percent;

(2) Major B. 2.5 percent; and

(3) Minor. 4.0 percent.

(h) Except as provided in paragraph

(i) of this section, inspection level IV as

described in MIL–STD–414, 11 June

1957, including Change Notice No.1,

‘‘Sampling Procedures and Tables for

Inspection by Variables for Percent

Defective,’’ or an equivalent procedure,

shall be used for major and minor

characteristics and 100 percent

inspection for critical characteristics.

Inspection level II as described in MIL–

STD–105D, 29 April 1963, ‘‘Sampling

Procedures and Tables for Inspection by

Attributes,’’ is an example of an

equivalent procedure.

(i) Subject to the approval of the

Institute, where the quality control plan

provisions for raw material, processes,

manufacturing, and fabrication,

inspections are adequate to ensure

control of finished article quality,

destructive testing of finished articles

may be conducted at a lower level of

inspection than that specified in

paragraph (h) of this section.

(The information collections

contained in this section are approved

under OMB control number 0920–0109)

§ 84.42 Proposed quality control plans;

approval by the Institute.

(a) Each proposed quality control plan

submitted in accordance with this

subpart shall be reviewed by the

Institute to determine its effectiveness

in ensuring the quality of respiratory

protection provided by the respirator for

which an approval is sought.

(b) If the Institute determines that the

proposed quality control plan submitted

by the applicant will not ensure

adequate quality control, the Institute

shall require the applicant to modify the

procedures and testing requirements of

the plan prior to approval of the plan

and issuance of any certificate of

approval.

(c) Approved quality control plans

shall constitute a part of and be

incorporated into any certificate of

approval issued by the Institute, and

compliance with such plans by the

applicant shall be a condition of

approval.

§ 84.43 Quality control records; review by

the Institute; revocation of approval.

(a) The applicant shall keep quality

control inspection records sufficient to

carry out the procedures required in

MIL–STD–414, 11 June 1957, including

Change Notice No. 1, ‘‘Sampling

Procedures and Tables for Inspection by

Variables for Percent Defective,’’ or an

approved equivalent sampling

procedure. MIL–STD–105D, 29 April

1963, ‘‘Sampling Procedures and Tables

for Inspection by Attributes,’’ is an

example of an approved equivalent

sampling procedure. MIL–STD–414 is

incorporated by reference and has been

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may

be obtained from DODSSP,

Standardization Document Order Desk,

700 Robbins Avenue, Bldg. 4D,

Philadelphia, Pa. 19111–5094. Copies

may be inspected at the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888, or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC. Copies of MIL–STD–

105D may be inspected or obtained from

the NIOSH, Certification and Quality

Assurance Branch, 1095 Willowdale

Road, Morgantown, WV 26505–2888.

(b) The Institute reserves the right to

have its representatives inspect the

applicant’s quality control test methods,

equipment, and records, and to

interview any employee or agent of the

applicant in regard to quality control

test methods, equipment, and records.

(c) The Institute reserves the right to

revoke, for cause, any certificate of

approval where it is found that the

applicant’s quality control test methods,

equipment, or records do not ensure

effective quality control over the

respirator for which the approval was

issued.

(The information collections

contained in this section are approved

under OMB control number 0920–0109)

Subpart F—Classification of Approved

Respirators; Scope of Approval;

Atmospheric Hazards; Service Time

§ 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.

§ 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
30362 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

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.

§ 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.

§ 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

§ 84.60 Construction and performance

requirements; general.

(a) The Institute shall issue approvals

for the types of respirators described in

subparts H through L of this part which

have met the minimum requirements set

forth for such respirators in this part.

(b) In addition to the types of

respirators specified in subparts H

through L of this part, the Institute shall

issue approvals for other respiratory

protective devices not specifically

described in this part subject to such

additional requirements as may be

imposed in accordance with § 84.63(c).

§ 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.

§ 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.

§ 84.63 Test requirements; general.

(a) Each respirator and respirator

component shall when tested by the

applicant and by the Institute, and meet

the applicable requirements set forth in

subparts H through L of this part.

(b) Where a combination respirator is

assembled from two or more types of

respirators, as described in this part,

each of the individual respirator types

which have been combined shall, as

applicable, meet the minimum

requirements for such respirators set

forth in subparts H through L of this

part, and such combination respirators,

except as specified in § 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.

§ 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.

§ 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
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30363

reserves the right, following the

issuance of such approval, to conduct

such public tests and demonstrations of

the approved respiratory equipment as

is deemed appropriate.

§ 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 mandays 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 § 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

§ 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.

§ 84.71 Self-contained breathing

apparatus; required components.

(a) Each self-contained breathing

apparatus described in § 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 selfcontained breathing apparatus shall

meet the minimum construction

requirements set forth in subpart G of

this part.

§ 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.

§ 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.

§ 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 selfcontained 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.

§ 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.

§ 84.76 Facepieces; eyepieces; minimum

requirements.

(a) Facepieces shall be designed and

constructed to provide adequate vision

which is not distorted by the eyepiece.

(b) All eyepieces shall be designed

and constructed to be impact and

penetration resistant. Federal

Specification, Mask, Air Line: and

Respirator, Air Filtering, Industrial,

GGG–M–125d, October 11, 1965 with

interim amendment-1, July 30, 1969, is

an example of an appropriate standard

for determining impact and penetration

resistance. Copies of GGG–M–125d may

be obtained from the NIOSH,

Certification and Quality Assurance
30364 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888.

§ 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.

§ 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.

§ 84.79 Breathing gas; minimum

requirements.

(a) Breathing gas used to supply

apparatus shall be respirable and

contain no less than 19.5 (dry

atmosphere) volume percent of oxygen.

(b) Oxygen, including liquid oxygen,

shall contain not less than 99.0 percent,

by volume, of pure O2, not more than

0.03%, by volume, carbon dioxide, and

not more than 0.001%, by volume,

carbon monoxide. Methods for making

these determinations can be found in

the U.S. Pharmacopeia National

Formulary. Containers used for oxygen

must not be treated with any toxic,

sleep-inducing, narcosis-producing, or

respiratory tract irritating compounds.

(c) Compressed, gaseous breathing air

shall meet the applicable minimum

grade requirements for Type I gaseous

air set forth in the Compressed Gas

Association Commodity Specification

for Air, G–7.1, 1966 (Grade D or higher

quality). G–7.1 is incorporated by

reference and has been approved by the

Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained

from American National Standards

Institute, Inc., 1430 Broadway, New

York, NY 10018. Copies may be

inspected at the NIOSH, Certification

and Quality Assurance Branch, 1095

Willowdale Road, Morgantown, WV

26505–2888, or at the Office of the

Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

(d) Compressed, liquefied breathing

air shall meet the applicable minimum

grade requirements for Type II liquid air

set forth in the Compressed Gas

Association Commodity Specification

for Air, G–7.1, 1966 (Grade B or higher

quality). G–7.1 is incorporated by

reference and has been approved by the

Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained

from American National Standards

Institute, Inc., 1430 Broadway, New

York, NY 10018. Copies may be

inspected at the NIOSH, Certification

and Quality Assurance Branch, 1095

Willowdale Road, Morgantown, WV

26505–2888, or at the Office of the

Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

§ 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.

§ 84.81 Compressed breathing gas and

liquefied breathing gas containers;

minimum requirements.

(a) Compressed breathing gas and

liquefied breathing gas containers shall

meet the minimum requirements of the

Department of Transportation for

interstate shipment of such containers

when fully charged.

(b) Such containers shall be

permanently and legibly marked to

identify their contents, e.g., compressed

breathing air, compressed breathing

oxygen, liquefied breathing air, or

liquefied breathing oxygen.

(c) Containers normally removed from

apparatus for refilling shall be equipped

with a dial indicating gage which shows

the pressure in the container.

(d) Compressed breathing gas

contained valves or a separate charging

system or adapter provided with each

apparatus shall be equipped with outlet

threads specified for the service by the

American Standards Association,

Compressed Gas Cylinder Valve Outlet

and Inlet Connections, B57.1–1965.

B57.1–1965 is incorporated by reference

and has been approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

Copies may be obtained from American

National Standards Institute, Inc., 1430

Broadway, New York, NY Copies may

be inspected at the NIOSH, Certification

and Quality Assurance Branch, 1095

Willowdale Road, Morgantown, WV

26505–2888, or at the Office of the

Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

§ 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 dialindicating 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, onehalf, three-quarters, and full.

(3) Stem gage readings shall not vary

from true readings by more than onesixteenth 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;
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30365

however, where the liquid content

cannot be rapidly vented, and the

service time of the device begins

immediately after filling, a timer shall

be provided in place of a visible gage.

§ 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.

§ 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) watercolumn 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.

§ 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.

§ 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.

§ 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.

§ 84.88 Breathing bag test.

(a) Breathing bags will be tested in an

air atmosphere saturated with gasoline

vapor at room temperature (24–30 °C./

75–85 °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 minutevolume of 40 liters.

(c) A breathing machine cam with a

work rate of 622 kp.-m./min. will be

used. The dimensions of a suitable

breathing machine cam are available

from the Institute upon request.

(d) The air within the bag(s) shall not

contain more than 100 parts per million

of gasoline vapor at the end of the test.

§ 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.

§ 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 § 84.88.

(b) The inhalation resistance of opencircuit 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 (§ 84.91(e)) and 10

cm. (4 inches) water-column height.

§ 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.
30366 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

(e) Resistance to exhalation airflow

will be measured in the facepiece or

mouthpiece of closed-circuit apparatus

with a breathing machine as described

in § 84.88, and the exhalation resistance

shall not exceed 51 mm. (2 inches)

water-column height.

§ 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.

§ 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.

§ 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.

§ 84.95 Service time test; open-circuit

apparatus.

(a) Service time will be measured

with a breathing machine as described

in § 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 opencircuit apparatus in accordance with

§ 84.53.

§ 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 § 84.53.

§ 84.97 Test for carbon dioxide in inspired

gas; open- and closed-circuit apparatus;

maximum allowable limits.

(a) Open-circuit apparatus:

(1) The concentration of carbon

dioxide in inspired gas in open-circuit

apparatus will be measured at the

mouth while the apparatus mounted on

a dummy head is operated by a

breathing machine. An acceptable

method for measuring the concentration

of carbon dioxide is described in Bureau

of Mines Report of Investigations 6865,

A Machine-Test Method for Measuring

Carbon Dioxide in the Inspired Air of

Self-Contained Breathing Apparatus,

1966. Copies of Report of Investigations

6865 may be inspected or obtained from

the NIOSH, Certification and Quality

Assurance Branch, 1095 Willowdale

Road, Morgantown, WV. 26505–2888.

(2) The breathing rate will be 14.5

respirations per minute with a minutevolume 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° C. (80 ± 5° 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:

Where the service

time is

Maximum allowable average concentration 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.

§ 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. (81⁄2 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.

§ 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
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30367

examination conducted by a qualified

physician.

(c) All man tests will be conducted by

the Institute.

(d) The apparatus will be examined

before each man test to ensure that it is

in proper working order.

(e) Breathing resistance will be

measured within the facepiece or

mouthpiece and the wearer’s pulse and

respiration rate will be recorded during

each 2 minute sample period prescribed

in tests 1, 2, 3, and 4.

(f) Man tests 1, 2, 3, 4, 5, and 6 will

be conducted in duplicate.

(g) If man tests are not completed

through no fault of the apparatus, the

test will be repeated.

§ 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.

§ 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

§ 84.79(a), and the maximum allowable

average concentration of carbon dioxide

specified in § 84.97(c).

(d) One sample of inspiration will be

taken in the case of 3-, 5-, and 10-

minute apparatus.

§ 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.

§ 84.103 Man tests; performance

requirements.

(a) The apparatus shall satisfy the

respiratory requirements of the wearer

for the classified service time.

(b) Fogging of the eyepiece shall not

obscure the wearer’s vision, and the

wearer shall not experience undue

discomfort because of fit or other

characteristics of the apparatus.

(c) When the ambient temperature

during testing is 24±6 °C. (75±10 °F.),

the maximum temperature of inspired

air recorded during man tests shall not

exceed the following, after correction for

deviation from 24 °C. (75 °F.):

Where service life of apparatus is—

Where percent

relative humidity of inspired

air is—

Maximum permissible

temperature of inspired

air shall not exceed—

°F. °C.

1⁄4 hour or less ..................................................................................................................................... 0–100 135 57 1⁄4 hour to 3⁄4 hour ................................................................................................................................ 0–50

50–100

125

1 110

52

1 43

1 to 2 hours .......................................................................................................................................... 0–50

50–100

115

1105

46

141

3 hours ................................................................................................................................................. 0–50

50–100

110

1100

43

1 38

4 hours ................................................................................................................................................. 0–50

50–100

105

1 95

41

1 35

1Where percent relative humidity is 50–100 and apparatus is designed for escape only, these maximum permissible temperatures will be increased by 5°C (10°F).

§ 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]

Activity

Service time—

3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour 2, 3, and 4

hours

Sampling and readings .. ................... ................... ................... 2 2 2 2 Perform 1

hour test 2,

3, or 4

times respectively.
30368 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

TABLE 1.—DURATION AND SEQUENCE OF SPECIFIC ACTIVITIES FOR TEST 1, IN MINUTES—Continued

[42 CFR part 84, subpart H]

Activity

Service time—

3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour 2, 3, and 4

hours

Walks at 4.8 km. (3

miles) per hour.

3 5 3 4 8 12 18

Sampling and readings .. ................... ................... 2 2 2 2 2

Walks at 4.8 km. (3

miles) per hour.

................... ................... 3 5 8 12 18

Sampling and readings .. ................... ................... 2 2 2 2 2

Walks at 4.8 km. (3

miles) per hour.

................... ................... ................... ................... 6 13 16

Sampling and readings .. ................... ................... ................... ................... 2 2 2

TABLE 2.—DURATION AND SEQUENCE OF SPECIFIC ACTIVITIES FOR TEST 2, IN MINUTES

[42 CFR part 84, subpart H]

Activity

Service time—

3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour 2, 3 and 4

hours 1

Sampling and readings .......... ................... ................... .................. 2 ............... 2 ............... 2 ............... 2 ............... 2

Walks at 4.8 km. (3 miles) per

hour.

................... ................... 1 ............... 1 ............... 3 ............... 4 ............... 6 ............... 10.

Carries 23 kg. (50 pound)

weight over overcast.

................... ................... 1 time in 2

minutes.

1 time in 2

minutes.

2 times in

4 minutes.

3 times in

6 minutes.

4 times in

8 minutes.

5 times in 10

minutes.

Walks at 4.8 km. (3 miles) per

hour.

................... ................... .................. 1 ............... 3 ............... 3 ............... 3 ............... 5.

Climbs vertical treadmill 2 (or

equivalent).

1 1 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... 1.

Walks at 4.8 km. (3 miles) per

hour.

................... 1 1 ............... .................. .................. 2 ............... 3 ............... 5

Climbs vertical treadmill (or

equivalent).

................... 1 .................. .................. .................. 1 ............... 1 ............... 1.

Sampling and readings .......... ................... ................... .................. .................. 2 ............... 2 ............... 2 ............... 2.

Walks at 4.8 km. (3 miles) per

hour.

................... ................... .................. 2 ............... 2 ............... 3 ............... 5 ............... 11.

Climbs vertical treadmill (or

equivalent).

................... ................... .................. 1 ............... 1 ............... 1 ............... 1 ............... 1.

Carries 23 kg. (50 pound)

weight over overcast.

................... ................... .................. 1 time in 2

minutes.

3 times in

6 minutes.

4 times in

8 minutes.

5 times in

10 minutes.

5 times in 10

minutes.

Sampling and readings .......... ................... ................... 2 ............... .................. .................. 2 ............... 2 ............... 2.

Walks at 4.8 km. (3 miles) per

hour.

................... ................... .................. 1 ............... 3 ............... 3 ............... 3 ...............

Climbs vertical treadmill (or

equivalent).

................... ................... 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... Then repeat

above activities

once.

Walks at 4.8 km. (3 miles) per

hour.

................... ................... 2 ............... .................. .................. 2 ............... 3

Climbs vertical treadmill (or

equivalent).

................... ................... .................. .................. .................. 1 ............... 1 ...............

Carries 20 kg. (45 pound)

weight and walks at 4.8 km.

(3 miles) per hour.

1 ................... .................. .................. .................. .................. 2 ...............

Walks at 4.8 km. (3 miles) per

hour.

1 2 .................. .................. .................. 1 ............... 4 ...............

Sampling and readings .......... ................... ................... .................. 2 ............... 2 ............... 2 ............... 2 ...............

1Total test time for Test 2 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.

2Treadmill shall be inclined 15° from vertical and operated at a speed of 1 foot per second.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30369

TABLE 3.—DURATION AND SEQUENCE OF SPECIFIC ACTIVITIES FOR TEST 3, IN MINUTES

[42 CFR part 84, subpart H]

Activity

Service time—

3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour 2, 3 and 4

hours 1

Sampling and readings .............. ................... .................. .................. 2 ............... 2 ............... 2 ............... 2 ............... (2)

Walks at 4.8 km. (3 miles) per

hour.

................... .................. 1 ............... 1 ............... 2 ............... 2 ............... 3 ............... ...................

Runs at 9.7 km. (6 miles) per

hour.

1 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... ...................

Pulls 20 kg. (45 pound) weight

to 5 feet.

................... 15 times in

1 minute.

.................. 30 times in

2 minutes.

30 times in

2 minutes.

30 times in

2 minutes.

60 times in

6 minutes.

...................

Lies on side ................................ 1/2 1 ............... 1 ............... 2 ............... 3 ............... 4 ............... 5 ............... ...................

Lies on back ............................... 1/2 1 ............... 1 ............... 2 ............... 2 ............... 3 ............... 3 ............... ...................

Crawls on hands and knees ...... 1 1 ............... 1 ............... 2 ............... 2 ............... 2 ............... 2 ............... ...................

Sampling and readings .............. ................... .................. 2 ............... .................. 2 ............... 2 ............... 2 ............... ...................

Runs at 9.7 km. (6 miles) per

hour.

................... .................. .................. 1 ............... 1 ............... 1 ............... 1 ............... ...................

Walks at 4.8 km. (3 miles) per

hour.

................... .................. .................. .................. 2 ............... 8 ............... 10 ............. ...................

Pulls 20 kg. (45 pound) weight

to 5 feet.

................... .................. 30 times in

2 minutes.

.................. 60 times in

6 minutes.

60 times in

6 minutes.

60 times in

6 minutes.

...................

Sampling and readings .............. ................... .................. .................. 2 ............... .................. 2 ............... 2 ............... ...................

Walks at 4.8 km. (3 miles) per

hour.

................... .................. 1 ............... .................. 3 ............... 4 ............... 10 ............. ...................

Lies on side ................................ ................... .................. .................. .................. .................. 2 ............... 4 ............... ...................

Lies on back ............................... ................... .................. .................. .................. .................. 2 ............... 1 ............... ...................

Sampling and readings .............. ................... .................. .................. .................. 2 ............... 2 ............... 2 ............... ...................

1Total test time for Test 3 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.

2Perform test No. 3 for 1 hr. apparatus; then perform test No. 1 for 1 hour apparatus.
30370 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

TABLE 4.—DURATION AND

SEQUENCE OF

SPECIFIC

ACTIVITIES FOR

TEST 4, IN

MINUTES

[42 CFR part 84, subpart H]

Activity

Service time—

3 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes 1 hour 2 hours 3 hours 4 hours

Sampling and readings .................................................... .................. .................. .................. 2 ............... 2 ............... 2 ............... 2 ............... (2) (3) (4)Walks at 4.8 km. (3 miles) per hour ................................ .................. .................. .................. 1 ............... 2 ............... 2 ............... 2 ............... ............... ............... ...............Climbs vertical treadmill 1 (or equivalent) ........................ 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... ............... ............... ...............Walks at 4.8 km. (3 miles) per hour ................................ .................. 1 ............... 1 ............... 1 ............... 2 ............... 2 ............... 2 ............... ............... ...............Pulls 20 kg. (45 pound) weight to 5 feet ......................... .................. 30 times in

2 minutes.

30 times in

2 minutes.

30 times in

2 minutes.

60 times in

5 minutes.

60 times in

5 minutes.

60 times in

5 minutes.

............... ............... ...............

Walks at 4.8 km. (3 miles) per hour ................................ .................. .................. 1 ............... 1 ............... 1 ............... 2 ............... 3 ............... ............... ............... ...............Carries 23 kg. (50 pound) weight over overcast ............. .................. .................. .................. 1 time in 1

minute.

1 time in 1

minute.

2 times in

3 minutes.

4 times in

8 minutes.

............... ............... ...............

Sampling and readings .................................................... .................. .................. 2 ............... .................. 2 ............... 2 ............... 2 ............... ............... ............... ...............Walks at 4.8 km. (3 miles) per hour ................................ .................. .................. .................. 1 ............... 3 ............... 3 ............... 4 ............... ............... ............... ...............Runs at 9.7 km. (6 miles) per hour ................................. .................. 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... 1 ............... ............... ............... ...............Carries 23 kg. (50 pound) weight over overcast ............. .................. .................. 1 time in 1

minute.

1 time in 1

minute.

2 times in

3 minutes.

4 times in

6 minutes.

6 times in

9 minutes.

............... ............... ...............

Pulls 20 kg (45 pound) weight to 5 feet .......................... 15 times in

1 minute.

.................. .................. 15 times in

1 minute.

60 times in

5 minutes.

30 times in

2 minutes.

36 times in

3 minutes.

............... ............... ...............

Sampling and readings .................................................... .................. .................. .................. 2 ............... 2 ............... 2 ............... 2 ............... ............... ............... ...............Walks at 4.8 km. (3 miles) per hour ................................ 1 ............... .................. 1 ............... .................. .................. 2 ............... 6 ............... ............... ...............Pulls 20 kg. (45 pound) weight to 5 feet ......................... .................. .................. .................. .................. .................. 60 times in

5 minutes.

60 times in

5 minutes.

............... ............... ...............

Carries 20 kg. (45 pound) weight and walks at 4.8 km.

(3 miles) per hour.

.................. .................. .................. .................. .................. 3 ............... 3 ............... ............... ............... ...............

Sampling and readings .................................................... .................. .................. .................. .................. .................. 2 ............... 2 ............... ............... ............... ...............

1Treadmill shall be inclined 15° from vertical and operated at a speed of 30 cm. (1 foot) per second. 2Perform test No. 1 for 30-minute apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 30-minute apparatus.3Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus.4Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus twice (i.e., two one-hour tests).
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30371

Subpart I—Gas Masks

§ 84.110 Gas masks; description.

(a) Gas masks including all

completely assembled air purifying

masks designed for use as respiratory

protection during entry into

atmospheres not immediately dangerous

to life or health or escape only from

hazardous atmospheres containing

adequate oxygen to support life are

described as follows:

(1) Front-mounted or back-mounted

gas mask. A gas mask which consists of

a full facepiece, a breathing tube, a

canister at the front or back, a canister

harness, and associated connections.

(2) Chin-style gas mask. A gas mask

which consists of a full facepiece, a

canister which is usually attached to the

facepiece, and associated connections.

(3) Escape gas mask. A gas mask

designed for use during escape only

from hazardous atmospheres which

consists of a facepiece or mouthpiece, a

canister, and associated connections.

(b) Gas masks shall be further

described according to the types of gases

or vapors against which they are

designed to provide respiratory

protection, as follows:

Type of front-mounted or back-mounted gas

mask:

Acid gas 1 2 3

Ammonia

Carbon monoxide

Organic Vapor 1 2 3

Other gas(es) and vapor(s) 1 2 3

Combination of two or more of the above

gases and vapors.1 2 3

Combination of acid gas, ammonia, carbon

monoxide, and organic vapors.1 2 3

Type of chin-style gas mask:

Acid gas 1 2 3

Ammonia

Carbon monoxide

Organic vapor 1 2 3

Other gas(es) and vapor 1 2 3

Combination of two or more of the above

gases and vapors.1 2 3

Type of escape gas mask:

Acid gas 1 2 3 4

Ammonia 4

Carbon monoxide

Organic vapor 1 2 3 4

Other gas(s) and vapor(s) 1 2 3 4

Combination of two or more of the above

gases and vapors. 1 2 3 4

1Approval may be for acid gases or organic

vapors as a class or for specific acid gases or

organic vapors. 2 Not for use against gases or vapors with

poor warning properties (except where MSHA

or Occupational Safety and Health Administration standards permit such use for a specific

gas or vapor), or those which generate high

heats or reaction with sorbent materials in the

canister.

3 Use of the gas mask may be limited by

factors such as lower explosive limit, toxicological effects, and facepiece fit. Limitations

on gas mask service life and sorbent capacity

limitations shall be specified by the applicant

in instructions for selection, use and maintenance of the gas mask. 4Eye protection may be required in certain

concentrations of gases and vapors.

(c) Gas masks for respiratory

protection against gases and vapors

other than those specified in paragraph

(b) of this section, may be approved

upon submittal of an application in

writing for approval to the Certification

and Quality Assurance Branch listing

the gas or vapor and suggested

maximum use concentration for the

specific type of gas mask. The Institute

will consider the application and accept

or reject it on the basis of effect on the

wearer’s health and safety and any field

experience in use of gas masks for such

exposures. If the application is

accepted, the Institute will test such

masks in accordance with the

requirements of this subpart.

§ 84.111 Gas masks; required

components.

(a) Each gas mask described in

§ 84.110 shall, where its design requires,

contain the following component parts:

(1) Facepiece or mouthpiece and

noseclip;

(2) Canister or cartridge;

(3) Canister harness;

(4) External check valve; and

(5) Breathing tube.

(b) The components of each gas mask

shall meet the minimum construction

requirements set forth in subpart G of

this part.

§ 84.112 Canisters and cartridges in

parallel; resistance requirements.

Where two or more canisters or

cartridges are used in parallel, their

resistance to airflow shall be essentially

equal.

§ 84.113 Canisters and cartridges; color

and markings; requirements.

The color and markings of all

canisters and cartridges or labels shall

conform with the requirements of the

American National Standards Institute,

American National Standard for

Identification of Air-Purifying

Respirator Canisters and Cartridges,

ANSI K13.1–1973. ANSI K13.1 is

incorporated by reference and has been

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may

be obtained from American National

Standards Institute, Inc., 1430

Broadway, New York, NY 10018. Copies

may be inspected at the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888, or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC.

§ 84.114 Filters used with canisters and

cartridges; location; replacement.

(a) Particulate matter filters used in

conjunction with a canister or cartridge

shall be located on the inlet side of the

canister or cartridge.

(b) Filters shall be incorporated in or

firmly attached to the canister or

cartridge and each filter assembly shall,

where applicable, be designed to permit

its easy removal from and replacement

in the canister or cartridge.

§ 84.115 Breathing tubes; minimum

requirements.

Flexible breathing tubes used in

conjunction with gas masks shall be

designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces

or mouthpieces;

(c) Interference with the wearer’s

activities; and

(d) Shutoff of airflow due to kinking,

or from chin or arm pressure.

§ 84.116 Harnesses; installation and

construction; minimum requirements.

(a) Each gas mask shall, where

necessary, be equipped with a suitable

harness designed and constructed to

hold the components of the gas mask in

position against the wearer’s body.

(b) Harnesses shall be designed and

constructed to permit easy removal and

replacement of gas mask parts, and

where applicable, provide for holding a

full facepiece in the ready position

when not in use.

§ 84.117 Gas mask containers; minimum

requirements.

(a) Gas masks shall be equipped with

a substantial, durable container bearing

markings which show the applicant’s

name, the type and commercial

designation of mask it contains and all

appropriate approval labels.

(b) Containers for gas masks shall be

designed and constructed to permit easy

removal of the mask.

§ 84.118 Half-mask facepieces, full

facepieces, and mouthpieces; fit; minimum

requirements.

(a) Half-mask facepieces and full

facepieces shall be designed and

constructed to fit persons with various

facial shapes and sizes either:

(1) By providing more than one

facepiece size; or

(2) By providing one facepiece size

which will fit varying facial shapes and

sizes.

(b) Full facepieces shall provide for

optional use of corrective spectacles or
30372 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

lenses, which shall not reduce the

respiratory protective qualities of the

gas mask.

(c) Half-mask facepieces shall not

interfere with the fit of common

industrial safety spectacles, as

determined by the Institute’s facepiece

tests in § 84.124.

(d) Gas masks with mouthpieces shall

be equipped with noseclips which are

securely attached to the mouthpiece or

gas mask and provide an airtight seal.

(e) Facepieces shall be designed to

prevent eyepiece fogging.

§ 84.119 Facepieces; eyepieces; minimum

requirements.

(a) Full facepieces shall be designed

and constructed to provide adequate

vision which is not distorted by the eye.

(b) All eyepieces shall be designed

and constructed to be impact and

penetration resistant. Federal

Specification, Mask, Air Line: and

Respirator, Air Filtering, Industrial,

GGG–M–125d, October 11, 1965 with

interim amendment-1, July 30, 1969, is

an example of an appropriate standard

for determining impact and penetration

resistance. Copies of GGG–M–125d may

be obtained from the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888.

§ 84.120 Inhalation and exhalation valves;

minimum requirements.

(a) Inhalation and exhalation valves

shall be provided where necessary and

protected against damage and distortion.

(b) Inhalation valves shall be designed

and constructed to prevent excessive

exhaled air from adversely affecting

cartridges, canisters, and filters.

(c) Exhalation valves shall be

protected against external influence,

and designed and constructed to

prevent inward leakage of contaminated

air.

§ 84.121 Head harnesses; minimum

requirements.

(a) Facepieces shall be equipped with

adjustable and replaceable head

harnesses, designed and constructed to

provide adequate tension during use

and an even distribution of pressure

over the entire area in contact with the

face.

(b) Mouthpieces shall be equipped,

where applicable, with adjustable and

replaceable harnesses designed and

constructed to hold the mouthpiece in

place.

§ 84.122 Breathing resistance test;

minimum requirements.

(a) Resistance to airflow will be

measured in the facepiece or

mouthpiece of a gas mask mounted on

a breathing machine both before and

after each test conducted in accordance

with §§ 84.124, 84.125, and 84.126, with

air flowing at a continuous rate of 85

liters per minute.

(b) The maximum allowable

resistance requirements for gas masks

are as follows:

MAXIMUM RESISTANCE

[mm. water-column height]

Type of gas mask

Inhalation

Exhalation

Initial Final 1

Front-mounted or back-mounted (without particulate filter) ..................................................................... 60 75 20

Front-mounted or back-mounted (with approved particulate filter) ......................................................... 70 85 20

Chin-style (without particulate filter) ......................................................................................................... 40 55 20

Chin-style (with approved particulate filter) ............................................................................................. 65 80 20

Escape (without particulate filter) ............................................................................................................. 60 75 20

Escape (with approved particulate filter) ................................................................................................. 70 85 20

1 Measured at end of the service life specified in Tables 5, 6, and 7 of this subpart.

§ 84.123 Exhalation valve leakage test.

(a) Dry exhalation valves and valve

seats will be subjected to a suction of 25

mm. water-column height while in a

normal operating position.

(b) Leakage between the valve and

valve seat shall not exceed 30 milliliters

per minute.

§ 84.124 Facepiece tests; minimum

requirements.

(a) The complete gas mask will be

fitted to the faces of persons having

varying facial shapes and sizes.

(b) Where the applicant specifies a

facepiece size or sizes for the gas mask,

together with the approximate

measurements of faces they are designed

to fit, the Institute will insure that test

subjects suit such facial measurements.

(c) Any gas mask parts which must be

removed to perform the facepiece or

mouthpiece fit test shall be replaceable

without special tools and without

disturbing the facepiece or mouthpiece

fit.

(d) The facepiece or mouthpiece fit

test, using positive or negative pressure

recommended by the applicant and

described in his instructions will be

used before each test specified in

paragraph (e) of this section, and in

§ 84.125.

(e)(1) Each wearer will enter a

chamber containing 100 p.p.m. isoamyl

acetate vapor for a half-mask facepiece

and 1,000 p.p.m. isoamyl acetate vapor

for a full facepiece or mouthpiece.

(2) The facepiece or mouthpiece may

be adjusted, if necessary, in the test

chamber before starting the tests.

(3) Each wearer will remain in the

chamber for 8 minutes while performing

the following activities:

(i) Two minutes, nodding and turning

head;

(ii) Two minutes, calisthenic arm

movements;

(iii) Two minutes, running in place;

and

(iv) Two minutes, pumping with a tire

pump into a 28 liter (1 cubic foot)

container.

(4) Each wearer shall not detect the

odor of isoamyl acetate during the test.

§ 84.125 Particulate tests; canisters

containing particulate filters; minimum

requirements.

Gas mask canisters containing filters

for protection against particulates (e.g.

dusts, fumes, mists, and smokes) in

combination with gases, vapors, or gases

and vapors, shall also comply with the

requirements as prescribed in §§ 84.170

through 84.183, except for the airflow

resistance test of § 84.181.

§ 84.126 Canister bench tests; minimum

requirements.

(a)(1) Bench tests, except for carbon

monoxide tests, will be made on an

apparatus that allows the test

atmosphere at 50±5 percent relative

humidity and room temperature (25±2.5

°C.) to enter the canister continuously at

concentrations and rates of flow
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30373

specified in Tables 5, 6, and 7 of this

subpart.

(2) Three canisters will be removed

from containers and tested as received

from the applicant.

(3) Two canisters, other than those

described in paragraph (a)(2) of this

section, will be equilibrated at room

temperature by passing 25 percent

relative humidity air through them at 64

liters per minute for 6 hours.

(4) Two canisters, other than those

described in paragraphs (a) (2) and (3)

of this section, will be equilibrated at

room temperature by passing 85 percent

relative humidity air through them at 64

liters per minute for 6 hours.

(5) The equilibrated canisters will be

resealed, kept in an upright position at

room temperature, and tested within 18

hours.

(b) Front-mounted and back-mounted

gas mask canisters will be tested and

shall meet the minimum requirements

set forth in Table 5 of this subpart.

(c)(1) Front-mounted, and backmounted, and chin-style canisters

designated as providing respiratory

protection against gases, ammonia,

organic vapors, carbon monoxide and

particulate contaminants shall have a

window or other indicator to warn the

gas mask wearer when the canister will

no longer satisfactorily remove carbon

monoxide from the inhaled air.

(2) Other types of front- and backmounted canisters may also be

equipped with a window or other

indicator to warn of imminent leakage

of other gases or vapors.

(3) The window indicator canisters

will be tested as regular canisters, but

shall show a satisfactory indicator

change or other warning before the

allowable canister penetration has

occurred.

(d) Chin-style gas mask canisters shall

meet the minimum requirements set

forth in Table 6 of this subpart.

(e) Escape gas mask canisters shall

meet the minimum requirements set

forth in Table 7 of this subpart.

Tables to Subpart I of Part 84

TABLE 5.—CANISTER BENCH TESTS AND REQUIREMENTS FOR FRONT-MOUNTED AND BACK-MOUNTED GAS MASK

CANISTERS

[42 CFR part 84, subpart I]

Canister type Test condition

Test atmosphere

Number

of tests

Maximum

allowable

penetratin

(parts per

million)

Minimum

service

life (minutes) 1Gas or

vapor

Concentration (parts

per million)

Flow rate

(liters per

minute)

Acid gas ................................................................ As received SO2 20,000 64 3 5 12

Equilibrated Cl2 20,000 64 3 5 12

SO2 20,000 32 4 5 12

Cl2 20,000 32 4 5 12

Organic vapor ....................................................... As received CCl4 20,000 64 3 5 12

Equilibrated CCl4 20,000 32 4 5 12

Ammonia ............................................................... As received NH3 30,000 64 3 50 12

Equilibrated NH3 30,000 32 4 50 12

Carbon monoxide ................................................. As received CO 20,000 4 64 2 (3) 60

Equilibrated CO 5,000 2 32 3 (3) 60

CO 3,000 2 32 3 (3) 60

Combination of 2 or 3 of above types 5

Combination of all above types 6

1 Minimum life will be determined at the indicated penetration.

2 Relative humidity of test atmosphere will be 95±3pct; temperature of test atmosphere will be 25±2.5° C. 3 Maximum allowable CO penetration will be 385 cm 3 during the minimum life. The penetration shall not exceed 500 p/m during this time. 4 Relative humidity of test atmosphere will be 95±3pct; temperature of test atmosphere entering the test fixture will be 0±2.5°C¥0°C. 5Test conditions and requirements will be applicable as shown in this table.

6Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and

ammonia will be 6 min instead of 12 min.

TABLE 6—Canister Bench Tests and Requirements for Chin-Style Gas Mask Canisters

[42 CFR part 84, subpart I]

Canister type Test condition

Test atmosphere

Number

of tests

Maximum

allowable

penetration

(parts per

million)

Minimum

service

life (minutes) 1

Gas or

vapor

Concentration (parts

per million)

Flow rate

(liters per

minute)

Acid gas ................................................................ As received

Equilibrated

SO2 50,000 64 3 5 12

Cl2 5,000 64 3 5 12

SO2 5,000 32 4 5 12

Cl2 5,000 32 4 5 12

Organic vapor ....................................................... As received

Equilibrated

CCl4 5,000 64 3 5 12

CCl4 5,000 32 4 5 12

Ammonia ............................................................... As received

Equilibrated

NH3 5,000 64 3 50 12

As received

Equilibrated

NH3 5,000 32 4 50 12

Carbon monoxide ................................................. As received CO 20,000 2 64 2 (3) 60

CO 5,000 4 32 3 (3) 60
30374 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

TABLE 6—Canister Bench Tests and Requirements for Chin-Style Gas Mask Canisters

[42 CFR part 84, subpart I]

Canister type Test condition

Test atmosphere

Number

of tests

Maximum

allowable

penetration

(parts per

million)

Minimum

service

life (minutes) 1Gas or

vapor

Concentration (parts

per million)

Flow rate

(liters per

minute)

CO 3,000 2 32 3 (3) 60

Combination of 2 or 3 of above types 5

Combination of all above types 6

1 Minimum life will be determined at the indicated penetration.

2 Relative humidity of test atmosphere will be 95 ± 3pct; temperature of test atmosphere will be 25 ± 2.5° C. 3 Maximum allowable CO penetration will be 385 cm 3 during the minimum life. The penetration shall not exceed 500 p/m during this time. 4 Relative humidity of test atmosphere will be 95 ± 3pct; temperature of test atmosphere entering the test fixture will be 0 ± 2.5° C¥0° C. 5Test conditions and requirements will be applicable as shown in this table.

6Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and

ammonia will be 6 min instead of 12 min.

TABLE 7.—CANISTER BENCH TESTS AND REQUIREMENTS FOR ESCAPE GAS MASK CANISTERS

[42 CFR part 84, subpart I]

Canister type Test condition

Test atmosphere

Number

of tests

Maximum

allowable

penetration

(parts per

million)

Minimum

service

life (minutes) 1

Gas or

vapor

Concentration (parts

per million)

Flow rate

(liters per

minute)

Acid gas ................................................................ As received ....... SO2 5,000 64 3 5 12

Equilibrated ....... Cl2 5,000 64 3 5 12

SO2 5,000 32 4 5 12

Cl2 5,000 32 4 5 12

Organic vapor ....................................................... As received ....... CCl4 5,000 64 3 5 12

Equilibrated ....... CCl4 5,000 32 4 5 12

Ammonia ............................................................... As received ....... NH3 5,000 64 3 50 12

Equilibrated ....... NH3 5,000 32 4 50 12

Carbon monoxide ................................................. As received ....... CO 10,000 2 32 2 (3) 4 60

CO 5,000 5 32 3 (3) 60

CO 3,000 2 32 3 (3) 60

1 Minimum life will be determined at the indicated penetration.

2 Relative humidity of test atmosphere will be 95≤3pct; temperature of test atmosphere will be 25±2.5° C. 3 Maximum allowable CO penetration will be 385 cm 3 during the minimum life. The penetration shall not exceed 500 p/m during this time. 4 If effluent temperature exceeds 100° C during this test, the escape gas mask shall be equipped with an effective heat exchanger. 5 Relative humidity of test atmosphere will be 95±3 pct; temperature of test atmosphere entering the test fixture will be 0±2.5° C—0° C.

Subpart J—Supplied-Air Respirators

§ 84.130 Supplied-air respirators;

description.

Supplied-air respirators, including all

completely assembled respirators

designed for use as respiratory

protection during entry into and escape

from atmospheres not immediately

dangerous to life or health are described

as follows:

(a) Type ‘‘A’’ supplied-air respirators.

A hose mask respirator, for entry into

and escape from atmospheres not

immediately dangerous to life or health,

which consists of a motor-driven or

hand-operated blower that permits the

free entrance of air when the blower is

not operating, a strong large-diameter

hose having a low resistance to airflow,

a harness to which the hose and the lifeline are attached and a tight-fitting

facepiece.

(b) Type ‘‘AE’’ supplied-air

respirators. A Type ‘‘A’’ supplied-air

respirator equipped with additional

devices designed to protect the wearer’s

head and neck against impact and

abrasion from rebounding abrasive

material, and with shielding material

such as plastic, glass, woven wire, sheet

metal, or other suitable material to

protect the window(s) of facepieces,

hoods, and helmets which do not

unduly interfere with the wearer’s

vision and permit easy access to the

external surface of such window(s) for

cleaning.

(c) Type ‘‘B’’ supplied-air respirators.

A hose mask respirator, for entry into

and escape from atmospheres not

immediately dangerous to life or health,

which consists of a strong largediameter hose with low resistance to

airflow through which the user draws

inspired air by means of his lungs alone,

a harness to which the hose is attached,

and a tight-fitting facepiece.

(d) Type ‘‘BE’’ supplied-air

respirators. A type ‘‘B’’ supplied-air

respirator equipped with additional

devices designed to protect the wearer’s

head and neck against impact and

abrasion from rebounding abrasive

material, and with shielding material

such as plastic, glass, woven wire, sheet

metal, or other suitable material to

protect the window(s) of facepieces,

hoods, and helmets which do not

unduly interfere with the wearer’s

vision and permit easy access to the

external surface of such window(s) for

cleaning.

(e) Type ‘‘C’’ supplied-air respirators.

An airline respirator, for entry into and

escape from atmospheres not

immediately dangerous to life or health,

which consists of a source of respirable

breathing air, a hose, a detachable

coupling, a control valve, orifice, a
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30375

demand valve or pressure demand

valve, an arrangement for attaching the

hose to the wearer, and a facepiece,

hood, or helmet.

(f) Type ‘‘CE’’ supplied-air respirators.

A type ‘‘C’’ supplied-air respirator

equipped with additional devices

designed to protect the wearer’s head

and neck against impact and abrasion

from rebounding abrasive material, and

with shielding material such as plastic,

glass, woven wire, sheet metal, or other

suitable material to protect the

window(s) of facepieces, hoods, and

helmets which do not unduly interfere

with the wearer’s vision and permit easy

access to the external surface of such

window(s) for cleaning.

§ 84.131 Supplied-air respirators; required

components.

(a) Each supplied-air respirator

described in § 84.130 shall, where its

design requires, contain the following

component parts:

(1) Facepiece, hood, or helmet;

(2) Air supply valve, orifice, or

demand or pressure-demand regulator;

(3) Hand operated or motor driven air

blower;

(4) Air supply hose;

(5) Detachable couplings;

(6) Flexible breathing tube; and

(7) Respirator harness.

(b) The component parts of each

supplied-air respirator shall meet the

minimum construction requirements set

forth in subpart G of this part.

§ 84.132 Breathing tubes; minimum

requirements.

Flexible breathing tubes used in

conjunction with supplied-air

respirators shall be designed and

constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces,

mouthpieces, hoods, or helmets;

(c) Interference with the wearer’s

activities; and

(d) Shutoff of airflow due to kinking,

or from chin or arm pressure.

§ 84.133 Harnesses; installation and

construction; minimum requirements.

(a) Each supplied-air respirator shall,

where necessary, be equipped with a

suitable harness designed and

constructed to hold the components of

the respirator in position against the

wearer’s body.

(b) Harnesses shall be designed and

constructed to permit easy removal and

replacement of respirator parts, and

where applicable, provide for holding a

full facepiece in the ready position

when not in use.

§ 84.134 Respirator containers; minimum

requirements.

Supplied-air respirators shall be

equipped with a substantial, durable

container bearing markings which show

the applicant’s name, the type and

commercial designation of the respirator

it contains, and all appropriate approval

labels.

§ 84.135 Half-mask facepieces, full

facepieces, hoods, and helmets; fit;

minimum requirements.

(a) Half-mask facepieces and full

facepieces shall be designed and

constructed to fit persons with various

facial shapes and sizes either:

(1) By providing more than one

facepiece size; or

(2) By providing one facepiece size

which will fit varying facial shapes and

sizes.

(b) Full facepieces shall provide for

optional use of corrective spectacles or

lenses, which shall not reduce the

respiratory protective qualities of the

respirator.

(c) Hoods and helmets shall be

designed and constructed to fit persons

with various head sizes, provide for the

optional use of corrective spectacles or

lenses, and insure against any

restriction of movement by the wearer.

(d) Facepieces, hoods, and helmets

shall be designed to prevent eyepiece

fogging.

§ 84.136 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

(a) Facepieces, hoods, and helmets

shall be designed and constructed to

provide adequate vision which is not

distorted by the eyepiece.

(b) All eyepieces except those on

Types B, BE, C, and CE supplied-air

respirators shall be designed and

constructed to be impact and

penetration resistant. Federal

Specification, Mask, Air Line: and

Respirator, Air Filtering, Industrial,

GGG–M–125d, October 11, 1965 with

interim amendment-1, July 30, 1969, is

an example of an appropriate standard

for determining impact and penetration

resistance. Copies of GGG–M–125d may

be obtained from the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888.

(c)(1) The eyepieces of AE, BE, and CE

type supplied-air respirators shall be

shielded by plastic, glass, woven wire,

sheet metal, or other suitable material

which does not interfere with the vision

of the wearer.

(2) Shields shall be mounted and

attached to the facepiece to provide easy

access to the external surface of the

eyepiece for cleaning.

§ 84.137 Inhalation and exhalation valves;

check valves; minimum requirements.

(a) Inhalation and exhalation valves

shall be provided where necessary and

protected against distortion.

(b) Exhalation valves shall be:

(1) Protected against damage and

external influence; and

(2) Designed and constructed to

prevent inward leakage of contaminated

air.

(c) Check valves designed and

constructed to allow airflow toward the

facepiece only shall be provided in the

connections to the facepiece or in the

hose fitting near the facepiece of all

Type A, AE, B, and BE supplied-air

respirators.

§ 84.138 Head harnesses; minimum

requirements.

Facepieces shall be equipped with

adjustable and replaceable head

harnesses which are designed and

constructed to provide adequate tension

during use, and an even distribution of

pressure over the entire area in contact

with the face.

§ 84.139 Head and neck protection;

supplied-air respirators; minimum

requirements.

Type AE, BE, and CE supplied-air

respirators shall be designed and

constructed to provide protection

against impact and abrasion from

rebounding abrasive materials to the

wearer’s head and neck.

§ 84.140 Air velocity and noise levels;

hoods and helmets; minimum

requirements.

Noise levels generated by the

respirator will be measured inside the

hood or helmet at maximum airflow

obtainable within pressure and hose

length requirements and shall not

exceed 80 dBA.

§ 84.141 Breathing gas; minimum

requirements.

(a) Breathing gas used to supply

supplied-air respirators shall be

respirable breathing air and contain no

less than 19.5 volume-percent of

oxygen.

(b) Compressed, gaseous breathing air

shall meet the applicable minimum

grade requirements for Type I gaseous

air set forth in the Compressed Gas

Association Commodity Specification

for Air, G–7.1, 1966 (Grade D or higher

quality). G–7.1 is incorporated by

reference and has been approved by the

Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained

from American National Standards

Institute, Inc., 1430 Broadway, New

York, NY 10018. Copies may be
30376 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

inspected at the NIOSH, Certification

and Quality Assurance Branch, 1095

Willowdale Road, Morgantown, WV

26505–2888, or at the Office of the

Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

(c) Compressed, liquefied breathing

air shall meet the applicable minimum

grade requirements for Type II liquid air

set forth in the Compressed Gas

Association Commodity Specification

for Air, G–7.1, 1966 (Grade B or higher

quality). G–7.1 is incorporated by

reference and has been approved by the

Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies may be obtained

from American National Standards

Institute, Inc., 1430 Broadway, New

York, NY 10018. Copies may be

inspected at the NIOSH, Certification

and Quality Assurance Branch, 1095

Willowdale Road, Morgantown, WV

26505–2888, or at the Office of the

Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

§ 84.142 Air supply source; hand-operated

or motor driven air blowers; Type A

supplied-air respirators; minimum

requirements.

(a) Blowers shall be designed and

constructed to deliver an adequate

amount of air to the wearer with either

direction of rotation, unless constructed

to permit rotation in one direction only,

and to permit the free entrance of air to

the hose when the blower is not

operated.

(b) No multiple systems, whereby

more than one user is supplied by one

blower, will be approved, unless each

hose line is connected directly to a

manifold at the blower.

§ 84.143 Terminal fittings or chambers;

Type B supplied-air respirators; minimum

requirements.

(a) Blowers or connections to air

supplies providing positive pressures

shall not be approved for use on Type

B supplied-air respirators.

(b) Terminal fittings or chambers

employed in Type B supplied-air

respirators, shall be:

(1) Installed in the inlet of the hose.

(2) Designed and constructed to

provide for the drawing of air through

corrosion resistant material arranged so

as to be capable of removing material

larger than 0.149 mm. in diameter (149

micrometers, 100-mesh, U.S. Standard

sieve).

(3) Installed to provide a means for

fastening or anchoring the fitting or

chamber in a fixed position in a zone of

respirable air.

§ 84.144 Hand-operated blower test;

minimum requirements.

(a) Hand-operated blowers shall be

tested by attaching them to a

mechanical drive and operating them 6

to 8 hours daily for a period of 100

hours at a speed necessary to deliver 50

liters of air per minute through each

completely assembled respirator. Each

respirator shall be equipped with the

maximum length of hose with which the

device is to be approved and the hose

shall be connected to each blower or

manifold outlet designed for hose

connections.

(b) The crank speed of the handoperated blower shall not exceed 50

revolutions per minute in order to

deliver the required 50 liters of air per

minute to each facepiece.

(c) The power required to deliver 50

liters of air per minute to each wearer

through the maximum length of hose

shall not exceed one-fiftieth

horsepower, and the torque shall not

exceed a force of 2.3 kg. (5 pounds) on

a 20 cm. (8-inch) crank, as defined in

§ 84.146.

(d) The blower shall operate

throughout the period without failure or

indication of excessive wear of bearings

or other working parts.

§ 84.145 Motor-operated blower test;

minimum requirements.

(a) Motor-operated blowers shall be

tested by operating them at their

specified running speed 6 to 8 hours

daily for a period of 100 hours when

assembled with the kind and maximum

length of hose for which the device is

to be approved and when connected to

each blower or manifold outlet designed

for hose connections.

(b) The connection between the motor

and the blower shall be so constructed

that the motor may be disengaged from

the blower when the blower is operated

by hand.

(c) The blower shall operate

throughout the period without failure or

indication of excessive wear of bearings

or other working parts.

(d) Where a blower, which is

ordinarily motor driven, is operated by

hand, the power required to deliver 50

liters of air per minute to each wearer

through the maximum length of hose

shall not exceed one-fiftieth

horsepower, and the torque shall not

exceed a force of 2.3 kg. (5 pounds) on

a 20 cm. (8-inch) crank, as defined in

§ 84.146.

(e) Where the respirator is assembled

with the facepiece and 15 m. (50 feet)

of the hose for which it is to be

approved, and when connected to one

outlet with all other outlets closed and

operated at a speed not exceeding 50

revolutions of the crank per minute, the

amount of air delivered into the

respiratory-inlet covering shall not

exceed 150 liters per minute.

§ 84.146 Method of measuring the power

and torque required to operate blowers.

As shown in Figure 1 of this section,

the blower crank is replaced by a

wooden drum, a (13 cm. (5 inches) in

diameter is convenient). This drum is

wound with about 12 m. (40 feet) of No.

2 picture cord, b. A weight, c, of

sufficient mass to rotate the blower at

the desired speed is suspended from

this wire cord. A mark is made on the

cord about 3 to 4.5 m. (10 to 15 feet)

from the weight, c. Another mark is

placed at a measured distance (6–9 m./

20–30 feet is convenient) from the first.

These are used to facilitate timing. To

determine the torque or horsepower

required to operate the blower, the drum

is started in rotation manually at or

slightly above the speed at which the

power measurement is to be made. The

blower is then permitted to assume

constant speed, and then as the first

mark on the wire leaves the drum, a

stopwatch is started. The watch is

stopped when the second mark leaves

the drum. From these data the footpounds per minute and the torque may

be calculated.

BILLING CODE 4160–19–P
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30377

Figure 1—Apparatus for measuring power required to operate blower. (42 CFR part 84, subpart J, § 84.146)

BILLING CODE 4160–19–C

§ 84.147 Type B supplied-air respirator;

minimum requirements.

No Type B supplied-air respirator

shall be approved for use with a blower

or with connection to an air supply

device at positive pressures.

§ 84.148 Type C supplied-air respirator,

continuous flow class; minimum

requirements.

(a) Respirators tested under this

section shall be approved only when

they supply respirable air at the

pressures and quantities required.

(b) The pressure at the inlet of the

hose connection shall not exceed 863

kN/m.2 (125 pounds per square inch

gage).

(c) Where the pressure at any point in

the supply system exceeds 863 kN/m.2

(125 pounds per square inch gage), the

respirator shall be equipped with a

pressure-release mechanism that will

prevent the pressure at the hose

connection from exceeding 863 kN/m.2

(125 pounds per square inch gage)

under any conditions.

§ 84.149 Type C supplied-air respirator,

demand and pressure demand class;

minimum requirements.

(a) Respirators tested under this

section shall be approved only when

used to supply respirable air at the

pressures and quantities required.

(b) The manufacturer shall specify the

range of air pressure at the point of

attachment of the air-supply hose to the

air-supply system, and the range of hose

length for the respirator. For example,

he might specify that the respirator be

used with compressed air at pressures

ranging from 280–550 kN/m.2 (40 to 80

pounds per square inch) with from 6 to

76 m. (15 to 250 feet) of air-supply hose.

(c) The specified air pressure at the

point of attachment of the hose to the

air-supply system shall not exceed 863

kN/m.2 (125 pounds per square inch

gage).

(d)(1) Where the pressure in the airsupply system exceeds 863 kN/m.2 (125

pounds per square inch gage), the

respirator shall be equipped with a

pressure-release mechanism that will

prevent the pressure at the point of

attachment of the hose to the air-supply

system from exceeding 863 kN/m.2 (125

pounds per square inch gage).

(2) The pressure-release mechanism

shall be set to operate at a pressure not

more than 20 percent above the

manufacturer’s highest specified

pressure. For example, if the highest

specified pressure is 863 kN/m.2 (125

pounds per square inch), the pressurerelease mechanism would be set to

operate at a maximum of 1,035 kN/m.2

(150 pounds per square inch).

§ 84.150 Air-supply line tests; minimum

requirements.

Air supply lines employed on Type A,

Type B, and Type C supplied-air

respirators shall meet the minimum test

requirements set forth in Table 8 of this

subpart.

§ 84.151 Harness test; minimum

requirements.

(a)(1) Shoulder straps employed on

Type A supplied-air respirators shall be

tested for strength of material, joints,

and seams and must separately

withstand a pull of 113 kg. (250 pounds)

for 30 minutes without failure.

(2) Belts, rings, and attachments for

life lines must withstand a pull of 136

kg. (300 pounds) for 30 minutes without

failure.

(3) The hose shall be firmly attached

to the harness so as to withstand a pull

of 113 kg. (250 pounds) for 30 minutes

without separating, and the hose

attachments shall be arranged so that

the pull or drag of the hose behind an

advancing wearer does not disarrange

the harness or exert pull upon the

facepiece.

(4) The arrangement and suitability of

all harness accessories and fittings will

be considered.

(b)(1) The harness employed on Type

B supplied-air respirators shall not be

uncomfortable, disturbing, or interfere

with the movements of the wearer.

(2) The harness shall be easily

adjustable to various sizes.

(3) The hose shall be attached to the

harness in a manner that will withstand

a pull of 45 kg. (100 pounds) for 30

minutes without separating or showing

signs of failure.
30378 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

(4) The design of the harness and

attachment of the line shall permit

dragging the maximum length of hose

considered for approval over a concrete

floor without disarranging the harness

or exerting a pull on the facepiece.

(5) The arrangement and suitability of

all harness accessories and fittings will

be considered.

(c) The harness employed on Type C

respirators shall be similar to that

required on the Type B respirator, or, it

may consist of a simple arrangement for

attaching the hose to a part of the

wearer’s clothing in a practical manner

that prevents a pull equivalent to

dragging the maximum length of the

hose over a concrete floor from exerting

pull upon the respiratory-inlet covering.

(d) Where supplied-air respirators

have a rigid or partly rigid head

covering, a suitable harness shall be

required to assist in holding this

covering in place.

§ 84.152 Breathing tube test; minimum

requirements.

(a)(1) Type A and Type B supplied-air

respirators shall employ one or two

flexible breathing tubes of the

nonkinking type which extend from the

facepiece to a connecting hose coupling

attached to the belt or harness.

(2) The breathing tubes employed

shall permit free head movement, insure

against closing off by kinking or by chin

or arm pressure, and they shall not

create a pull that will loosen the

facepiece or disturb the wearer.

(b) Breathing tubes employed on Type

C supplied-air respirators of the

continuous flow class shall meet the

minimum requirements set forth in

paragraph (a) of this section, however,

an extension of the connecting hose may

be employed in lieu of the breathing

tubes required.

(c)(1) A flexible, nonkinking type

breathing tube shall:

(i) Be employed on Type C suppliedair respirators of the demand and

pressure-demand class; and

(ii) Extend from the facepiece to the

demand or pressure-demand valve,

except where the valve is attached

directly to the facepiece.

(2) The breathing tube shall permit

free head movement, insure against

closing off by kinking or by chin or arm

pressure, and shall not create a pull that

will loosen the facepiece or disturb the

wearer.

§ 84.153 Airflow resistance test, Type A

and Type AE supplied-air respirators;

minimum requirements.

(a) Airflow resistance will be

determined when the respirator is

completely assembled with the

respiratory-inlet covering, the air-supply

device, and the maximum length of airsupply hose coiled for one-half its

length in loops 1.5 to 2.1 m. (5 to 7 feet)

in diameter.

(b) The inhalation resistance, drawn

at the rate of 85 liters (3 cubic feet) per

minute when the blower is not

operating or under any practical

condition of blower operation shall not

exceed the following amounts:

Maximum length of hose for which respirator is approved Maximum resistance, water column height

Feet Meters Inches Millimeters

75 23 1.5 38

150 46 2.5 64

250 76 3.5 89

300 91 4.0 102

(c) The exhalation resistance shall not

exceed 25 mm. (1 inch) of water-column

height at a flow rate of 85 liters (3 cubic

feet) per minute when the blower is not

operating or under any practical

condition of blower operation.

§ 84.154 Airflow resistance test; Type B

and Type BE supplied-air respirators;

minimum requirements.

(a) Airflow resistance shall be

determined when the respirator is

completely assembled with the

respiratory-inlet covering and the hose

in the maximum length to be considered

for approval, coiled in loops 1.5 to 2.1

m. (5 to 7 feet) in diameter.

(b) Airflow resistance shall not exceed

38 mm. (1.5 inches) of water-column

height to air drawn at the flow rate of

85 liters (3 cubic feet) per minute.

(c) The exhalation resistance shall not

exceed 25 mm. (1 inch) of water-column

height at this flow rate.

§ 84.155 Airflow resistance test; Type C

supplied-air respirator, continuous flow

class and Type CE supplied-air respirator;

minimum requirements.

The resistance to air flowing from the

respirator shall not exceed 25 mm. (1

inch) of water-column height when the

air flow into the respiratory-inlet

covering is 115 liters (4 cubic feet) per

minute.

§ 84.156 Airflow resistance test; Type C

supplied-air respirator, demand class;

minimum requirements.

(a) Inhalation resistance shall not

exceed 50 millimeters (2 inches) of

water at an air flow of 115 liters (4 cubic

feet) per minute.

(b) The exhalation resistance to a flow

of air at a rate of 85 liters (3 cubic feet)

per minute shall not exceed 25

millimeters (1 inch) of water.

§ 84.157 Airflow resistance test; Type C

supplied-air respirator, pressure-demand

class; minimum requirements.

(a) The static pressure in the facepiece

shall not exceed 38 mm. (1.5 inches) of

water-column height.

(b) The pressure in the facepiece shall

not fall below atmospheric at inhalation

airflows less than 115 liters (4 cubic

feet) per minute.

(c) The exhalation resistance to a flow

of air at a rate of 85 liters (3 cubic feet)

per minute shall not exceed the static

pressure in the facepiece by more than

51 mm. (2 inches) of water-column

height.

§ 84.158 Exhalation valve leakage test.

(a) Dry exhalation valves and valve

seats will be subjected to a suction of 25

mm. water-column height while in a

normal operating position.

(b) Leakage between the valve and

valve seat shall not exceed 30 milliliters

per minute.

§ 84.159 Man tests for gases and vapors;

supplied-air respirators; general

performance requirements.

(a) Wearers will enter a chamber

containing a gas or vapor as prescribed

in §§ 84.160, 84.161, 84.162, and 84.163.

(b) Each wearer will spend 10 minutes

in work to provide observations on

freedom of the device from leakage. The

freedom and comfort allowed the wearer

will also be considered.

(c) Time during the test period will be

divided as follows:

(1) Five minutes. Walking, turning

head, dipping chin; and

(2) Five minutes. Pumping air with a

tire pump into a 28-liter (1 cubic foot)

container, or equivalent work.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30379

(d) No odor of the test gas or vapor

shall be detected by the wearer in the air

breathed during any such test, and the

wearer shall not be subjected to any

undue discomfort or encumbrance

because of the fit, air delivery, or other

features of the respirator during the

testing period.

§ 84.160 Man test for gases and vapors;

Type A and Type AE respirators; test

requirements.

(a) The completely assembled

respirator will be worn in a chamber

containing 0.1±0.025 percent isoamyl

acetate vapor, and the blower, the intake

of the hose, and not more than 25

percent of the hose length will be

located in isoamyl acetate-free air.

(b) The man in the isoamyl acetate

atmosphere will draw his inspired air

through the hose, connections, and all

parts of the air device by means of his

lungs alone (blower not operating).

(c) The 10-minute work test will be

repeated with the blower in operation at

any practical speed up to 50 revolutions

of the crank per minute.

§ 84.161 Man test for gases and vapors;

Type B and Type BE respirators; test

requirements.

(a) The completely assembled

respirator will be worn in a chamber

containing 0.1±0.025 percent isoamyl

acetate vapor, and the intake of the

hose, and not more than 25 percent of

the hose length will be located in

isoamyl acetate-free air.

(b) The man in the isoamyl acetate

atmosphere will draw his inspired air

through the hose and connections by

means of his lungs alone.

§ 84.162 Man test for gases and vapors;

Type C respirators, continuous-flow class

and Type CE supplied-air respirators; test

requirements.

(a) The completely assembled

respirator will be worn in a chamber

containing 0.1±0.025 percent isoamyl

acetate vapor, the intake of the hose will

be connected to a suitable source of

respirable air, and not more than 25

percent of the hose length will be

located in isoamyl acetate-free air.

(b) The minimum flow of air required

to maintain a positive pressure in the

respiratory-inlet covering throughout

the entire breathing cycle will be

supplied to the wearer, provided

however, that airflow shall not be less

than 115 liters per minute for tightfitting and not less than 170 liters per

minute for loose-fitting respiratory inletcoverings.

(c) The test will be repeated with the

maximum rate of flow attainable within

specified operating pressures.

§ 84.163 Man test for gases and vapors;

Type C supplied-air respirators, demand

and pressure-demand classes; test

requirements.

(a) The completely assembled

respirator will be worn in a chamber

containing 0.1±0.025 percent isoamyl

acetate vapor, the intake of the hose will

be connected to a suitable source of

respirable air, and not more than 25

percent of the hose length will be

located in isoamyl acetate-free air.

(b) The test will be conducted at the

minimum pressure with the maximum

hose length and will be repeated at the

maximum pressure with the minimum

hose length.

Tables to Subpart J of Part 84

TABLE 8—AIR-SUPPLY-LINE REQUIREMENTS AND TESTS

[42 CFR part 84, subpart J]

Specific requirements

Requirements for the air-supply lines of the indicated type of supplied-air respirators

Type A Type B Type C

Length of hose .................... Maximum of 91 m. (300

feet), in multiples of 7.6

m. (25 feet).

Maximum of 23 m. (75

feet) in multiples of 7.6

m. (25 feet).

Maximum of 91 m. (300 feet) in multiples of 7.6 m. (25

feet). It will be permissible for the applicant to supply hose of the approved type of shorter length than

7.6 m. (25 feet) provided it meets the requirements

of the part.

Air flow ................................ None .................................. None .................................. The air-supply hose with air regulating valve or orifice

shall permit a flow of not less than 115 liters (4

cubic feet) per minute to tight-fitting and 170 liters (6

cubic feet) per minute to loose-fitting respiratory-inlet

coverings through the maximum length of hose for

which approval is granted and at the minimum specified air-supply pressure. The maximum flow shall

not exceed 425 liters (15 cubic feet) per minute at

the maximum specified air-supply pressure with the

minimum length of hose for which approval is granted.
30380 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

TABLE 8—AIR-SUPPLY-LINE REQUIREMENTS AND TESTS—Continued

[42 CFR part 84, subpart J]

Specific requirements

Requirements for the air-supply lines of the indicated type of supplied-air respirators

Type A Type B Type C

Air flow ................................ ......do ................................. ......do ................................. The air-supply hose, detachable coupling, and demand valve of the demand class or pressure-demand valve of the pressure-demand class for Type

C supplied-air respirators, demand and pressure-demand classes, shall be capable of delivering respirable air at a rate of not less than 115 liters (4

cubic feet) per minute to the respiratory-inlet covering at an inhalation resistance not exceeding 50 millimeters (2 inches) of water-column height measured

in the respiratory-inlet covering with any combination

of air-supply pressure and length of hose within the

applicant’s specified range of pressure and hose

length. The air-flow rate and resistance to inhalation

shall be measured while the demand or pressuredemand valve is actuated 20 times per minute by a

source of intermittent suction. The maximum rate of

flow to the respiratory-inlet covering shall not exceed 425 liters (15 cubic feet) per minute under the

specified operating conditions.

Air-regulating valve ............. ......do ................................. ......do ................................. If an air-regulating valve is provided, it shall be so designed that it will remain at a specific adjustment,

which will not be affected by the ordinary movement

of the wearer. The valve must be so constructed

that the air supply with the maximum length of hose

and at the minimum specified air-supply pressure

will not be less than 115 liters (4 cubic feet) of air

per minute to tight-fitting and 170 liters (6 cubic feet)

of air per minute of loose-fitting respiratory inlet coverings for any adjustment of the valve. If a demand

or pressure-demand valve replaces the air-regulating valve, it shall be connected to the air-supply at

the maximum air pressure for which approval is

sought by means of the minimum length of air-supply hose for which approval is sought. The outlet of

the demand or pressure-demand valve shall be connected to a source of intermittent suction so that the

demand or pressure-demand valve is actuated approximately 20 times per minute for a total of

100,000 inhalations. To expedite this test, the rate

of actuation may be increased if mutually agreeable

to the applicant and NIOSH. During this test the

valve shall function without failure and without excessive wear of the moving parts. The demand or

pressure-demand valve shall not be damaged in any

way when subjected at the outlet to a pressure or

suction of 25 cm. (10 inches) of water gage for 2

minutes.

Noncollapsibility .................. The hose shall not collapse

or exhibit permanent deformation when a force

of 90 kg. (200 pounds) is

applied for 5 minutes between 2 planes 7.6 cm.

(3 inches) wide on opposite sides of the hose.

Same as Type A ................ None.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30381

TABLE 8—AIR-SUPPLY-LINE REQUIREMENTS AND TESTS—Continued

[42 CFR part 84, subpart J]

Specific requirements

Requirements for the air-supply lines of the indicated type of supplied-air respirators

Type A Type B Type C

Nonkinkability ...................... None .................................. None .................................. A 7.6 m. (25 foot) section of the hose will be placed

on a horizontal-plane surface and shaped into a

one-loop coil with one end of the hose connected to

an airflow meter and the other end of the hose supplied with air at the minimum specified supply pressure. The connection shall be in the plane of the

loop. The other end of the hose will be pulled tangentially to the loop and in the plane of the loop

until the hose straightens. To meet the requirements

of this test the loop shall maintain a uniform nearcircular shape and ultimately unfold as a spiral, without any localized deformation that decreases the

flow of air to less than 90 percent of the flow when

the hose is tested while remaining in a straight line.

Strength of hose and couplings.Hose and couplings shall

not separate or fail when

tested with a pull of 113

kg. (250 pounds) for 5

minutes.

Same as Type A ................ Hose and couplings shall not exhibit any separation or

failure when tested with a pull of 45 kg. (100

pounds) for 5 minutes and when tested by subjecting them to an internal air pressure of 2 times the

maximum respirator-supply pressure that is specified by the applicant or at 173 kN/m. 2 (25 pounds

per square inch) gage, whichever is higher.

Tightness ............................ No air leakage shall occur

when the hose and couplings are joined and the

joint(s) are immersed in

water and subjected to

an internal air pressure

of 35 kN/m. 2 (5 pounds

per square inch) gage.

None .................................. Leakage of air exceeding 50 cc. per minute at each

coupling shall not be permitted when the hose and

couplings are joined and are immersed in water,

with air flowing through the respirator under a pressure of 173 kN/m. 2 (25 pounds per square inch)

gage applied to the inlet end of the air-supply hose,

or at twice the maximum respirator-supply pressure

that is specified by the applicant, whichever is higher.

Permeation of hose by gasoline.The permeation of the

hose by gasoline will be

tested by immersing 7.6

m. (25 feet) of hose and

one coupling in gasoline,

with air flowing through

the hose at the rate of 8

liters per minute for 6

hours. The air from the

hose shall not contain

more than 0.01 percent

by volume of gasoline

vapor at the end of the

test.

Same as for Type A .......... Same as for Type A, except the test period shall be 1

hour.

Detachable coupling ........... None .................................. None .................................. A hand-operated detachable coupling by which the

wearer can readily attach or detach the connecting

hose shall be provided at a convenient location.

This coupling shall be durable, remain connected

under all conditions of normal respirator use, and

meet the prescribed tests for strength and tightness

of hose and couplings.

Subpart K—Non-Powered Air-Purifying

Particulate Respirators

§ 84.170 Non-powered air-purifying

particulate respirators; description.

(a) Non-powered air-purifying

particulate respirators utilize the

wearer’s negative inhalation pressure to

draw the ambient air through the airpurifying filter elements (filters) to

remove particulates from the ambient

air. They are designed for use as

respiratory protection against

atmospheres with particulate

contaminants (e.g., dusts, fumes, mists)

that are not immediately dangerous to

life or health and that contain adequate

oxygen to support life.

(b) Non-powered air-purifying

particulate respirators are classified into

three series, N-, R-, and P-series. The Nseries filters are restricted to use in

those workplaces free of oil aerosols.

The R- and P-series filters are intended

for removal of any particulate that

includes oil-based liquid particulates.

(c) Non-powered air-purifying

particulate respirators are classified

according to the efficiency level of the

filter(s) as tested according to the

requirements of this part.

(1) N100, R100, and P100 filters shall

demonstrate a minimum efficiency level

of 99.97 percent.

(2) N99, R99, and P99 filters shall

demonstrate a minimum efficiency level

of 99 percent.
30382 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

(3) N95, R95, and P95 filters shall

demonstrate a minimum efficiency level

of 95 percent.

§ 84.171 Non-powered air-purifying

particulate respirators; required

components.

(a) Each non-powered air-purifying

particulate respirator described in

§ 84.170 shall, where its design requires,

contain the following component parts:

(1) Facepiece, mouthpiece with

noseclip, hood, or helmet;

(2) Filter unit;

(3) Harness;

(4) Attached blower; and

(5) Breathing tube.

(b) The components of each nonpowered air-purifying particulate

respirator shall meet the minimum

construction requirements set forth in

subpart G of this part.

§ 84.172 Breathing tubes; minimum

requirements.

Flexible breathing tubes used in

conjunction with respirators shall be

designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces,

mouthpieces, hoods, or helmets;

(c) Interference with the wearer’s

activities; and

(d) Shutoff of airflow due to kinking,

or from chin or arm pressure.

§ 84.173 Harnesses; installation and

construction; minimum requirements.

(a) Each respirator shall, where

necessary, be equipped with a suitable

harness designed and constructed to

hold the components of the respirator in

position against the wearer’s body.

(b) Harnesses shall be designed and

constructed to permit easy removal and

replacement of respirator parts, and,

where applicable, provide for holding a

full facepiece in the ready position

when not in use.

§ 84.174 Respirator containers; minimum

requirements.

(a) Except as provided in paragraph

(b) of this section each respirator shall

be equipped with a substantial, durable

container bearing markings which show

the applicant’s name, the type of

respirator it contains, and all

appropriate approval labels.

(b) Containers for single-use

respirators may provide for storage of

more than one respirator, however, such

containers shall be designed and

constructed to prevent contamination of

respirators which are not removed, and

to prevent damage to respirators during

transit.

§ 84.175 Half-mask facepieces, full

facepieces, hoods, helmets, and

mouthpieces; fit; minimum requirements.

(a) Half-mask facepieces and full

facepieces shall be designed and

constructed to fit persons with various

facial shapes and sizes either:

(1) By providing more than one

facepiece size; or

(2) By providing one facepiece size

which will fit varying facial shapes and

sizes.

(b) Full facepieces shall provide for

optional use of corrective spectacles or

lenses, which shall not reduce the

respiratory protective qualities of the

respirator.

(c) Hoods and helmets shall be

designed and constructed to fit persons

with various head sizes, provide for the

optional use of corrective spectacles or

lenses, and insure against any

restriction of movement by the wearer.

(d) Mouthpieces shall be equipped

with noseclips which are securely

attached to the mouthpiece or respirator

and provide an airtight seal.

(e) Facepieces, hoods, and helmets

shall be designed to prevent eyepiece

fogging.

(f) Half-mask facepieces shall not

interfere with the fit of common

industrial safety corrective spectacles.

§ 84.176 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

Facepieces, hoods, and helmets shall

be designed and constructed to provide

adequate vision which is not distorted

by the eyepieces.

§ 84.177 Inhalation and exhalation valves;

minimum requirements.

(a) Inhalation and exhalation valves

shall be protected against distortion.

(b) Inhalation valves shall be designed

and constructed and provided where

necessary to prevent excessive exhaled

air from adversely affecting filters,

except where filters are specifically

designed to resist moisture.

(c) Exhalation valves shall be:

(1) Provided where necessary;

(2) Protected against damage and

external influence; and

(3) Designed and constructed to

prevent inward leakage of contaminated

air.

§ 84.178 Head harnesses; minimum

requirements.

(a) All facepieces shall be equipped

with head harnesses designed and

constructed to provide adequate tension

during use and an even distribution of

pressure over the entire area in contact

with the face.

(b) Facepiece head harnesses, except

those employed on single-use

respirators, shall be adjustable and

replaceable.

(c) Mouthpieces shall be equipped,

where applicable, with adjustable and

replaceable harnesses, designed and

constructed to hold the mouthpiece in

place.

§ 84.179 Non-powered air-purifying

particulate respirators; filter identification.

(a) The respirator manufacturer, as

part of the application for certification,

shall specify the filter series and the

filter efficiency level (i.e., ‘‘N95’’, ‘‘R95,

‘‘P95’’, ‘‘N99, ‘‘R99’’, ‘‘P99’’, ‘‘N100’’,

‘‘R100’’, or ‘‘P100’’) for which

certification is being sought.

(b) Filters shall be prominently

labeled as follows:

(1) N100 filters shall be labeled ‘‘N100

Particulate Filter (99.97% filter

efficiency level)’’ and shall be a color

other than magenta.

(2) R100 filters shall be labeled ‘‘R100

Particulate Filter (99.97% filter

efficiency level)’’ and shall be a color

other than magenta.

(3) P100 filters shall be labeled ‘‘P100

Particulate Filter (99.97% filter

efficiency level)’’ and shall be color

coded magenta.

(4) N99 filters shall be labeled ‘‘N99

Particulate Filter (99% filter efficiency

level)’’ and shall be a color other than

magenta.

(5) R99 filters shall be labeled ‘‘R99

Particulate Filter (99% filter efficiency

level)’’ and shall be a color other than

magenta.

(6) P99 filters shall be labeled ‘‘P99

Particulate Filter (99% filter efficiency

level)’’ and shall be a color other than

magenta.

(7) N95 filters shall be labeled as

‘‘N95 Particulate Filter (95% filter

efficiency level)’’ and shall be a color

other than magenta.

(8) R95 filters shall be labeled as ‘‘R95

Particulate Filter (95% filter efficiency

level)’’ and shall be a color other than

magenta.

(9) P95 filters shall be labeled as ‘‘P95

Particulate Filter (95% filter efficiency

level)’’ and shall be a color other than

magenta.

§ 84.180 Airflow resistance tests.

(a) Resistance to airflow will be

measured in the facepiece, mouthpiece,

hood, or helmet of a particulate

respirator (complete respirator)

mounted on a test fixture with air

flowing at continuous rate of 85±2 liters

per minute, before each test conducted

in accordance with § 84.182.

(b) The resistances for particulate

respirators upon initial inhalation shall

not exceed 35 mm water column height

pressure and upon initial exhalation

shall not exceed 25 mm water column

height pressure.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30383

§ 84.181 Non-powered air-purifying

particulate filter efficiency level

determination.

(a) Twenty filters of each nonpowered air-purifying particulate

respirator model shall be tested for filter

efficiency against:

(1) A solid sodium chloride

particulate aerosol as per this section, if

N-series certification is requested by the

applicant.

(2) A dioctyl phthalate or equivalent

liquid particulate aerosol as per this

section, if R-series or P-series

certification is requested by the

applicant.

(b) Filters including holders and

gaskets; when separable, shall be tested

for filter efficiency level, as mounted on

a test fixture in the manner as used on

the respirator.

(c) Prior to filter efficiency testing of

20 N-series filters, the 20 to be tested

shall be taken out of their packaging and

placed in an environment of 85±5

percent relative humidity at 38±2.5 °C

for 25±1 hours. Following the preconditioning, filters shall be sealed in a

gas-tight container and tested within 10

hours.

(d) When the filters do not have

separable holders and gaskets, the

exhalation valves shall be blocked so as

to ensure that leakage, if present, is not

included in the filter efficiency level

evaluation.

(e) For non-powered air-purifying

particulate respirators with a single

filter, filters shall be tested at a

continuous airflow rate of 85±4 liters

per minute. Where filters are to be used

in pairs, the test-aerosol airflow rate

shall be 42.5±2 liters per minute

through each filter.

(f) Filter efficiency test aerosols.

(1) When testing N-series filters, a

sodium chloride or equivalent solid

aerosol at 25±5 °C and relative humidity

of 30±10 percent that has been

neutralized to the Boltzmann

equilibrium state shall be used. Each

filter shall be challenged with a

concentration not exceeding 200 mg/m3.

(2) When testing R-series and P-series

filters, a neat cold-nebulized dioctyl

phthalate (DOP) or equivalent aerosol at

25±5 °C that has been neutralized to the

Boltzmann equilibrium state shall be

used. Each filter shall be challenged

with a concentration not exceeding 200

mg/m3.

(3) The test shall continue until

minimum efficiency is achieved or until

an aerosol mass of at least 200±5 mg has

contacted the filter. For P-series filters,

if the filter efficiency is decreasing

when the 200±5 mg challenge point is

reached, the test shall be continued

until there is no further decrease in

efficiency.

(g) The sodium chloride test aerosol

shall have a particle size distribution

with count median diameter of

0.075±0.020 micrometer and a standard

geometric deviation not exceeding 1.86

at the specified test conditions as

determined with a scanning mobility

particle sizer or equivalent. The DOP

aerosol shall have a particle size

distribution with count median

diameter of 0.185±0.020 micrometer and

a standard geometric deviation not

exceeding 1.60 at the specified test

conditions as determined with a

scanning mobility particle sizer or

equivalent.

(h) The efficiency of the filter shall be

monitored and recorded throughout the

test period by a suitable forward-lightscattering photometer or equivalent

instrumentation.

(i) The minimum efficiency for each

of the 20 filters shall be determined and

recorded and be equal to or greater than

the filter efficiency criterion listed for

each level as follows:

P100, R100 and N100: Efficiency ≥99.97%

P99, R99 and N99: Efficiency ≥99%

P95, R95 and N95: Efficiency ≥95%

§ 84.182 Exhalation valve leakage test;

minimum requirements.

(a) Dry exhalation valves and valve

seats will be subjected to a suction of 25

mm. water-column height while in a

normal operating position.

(b) Leakage between the valve and

valve seat shall not exceed 30 milliliters

per minute.

Subpart L—Chemical Cartridge

Respirators

§ 84.190 Chemical cartridge respirators:

description.

(a) Chemical cartridge respirators

including all completely assembled

respirators which are designed for use

as respiratory protection during entry

into or escape from atmospheres not

immediately dangerous to life and

health, are described according to the

specific gases or vapors against which

they are designed to provide respiratory

protection, as follows:

Type of chemical cartridge respirator 1

Maximum

use concentration,

parts per

million

Ammonia ................................... 300

Chlorine .................................... 10

Hydrogen chloride .................... 50

Methyl amine ............................ 100

Organic vapor ........................... 2 1,000

Sulfur dioxide ............................ 50

Type of chemical cartridge respirator 1

Maximum

use concentration,

parts per

million

Vinyl chloride ............................ 10

1 Not for use against gases or vapors with

poor warning properties (except where MSHA

or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate

high heats of reaction with sorbent material in

the cartridge. 2 Maximum use concentrations are lower for

organic vapors which produce atmospheres

immediately hazardous to life or health at concentrations equal to or lower than this concentration.

(b) Chemical cartridge respirators for

respiratory protection against gases or

vapors, which are not specifically listed

with their maximum use concentration,

may be approved if the applicant

submits a request for such approval, in

writing, to the Institute. The Institute

shall consider each such application

and accept or reject the application after

a review of the effects on the wearer’s

health and safety and in the light of any

field experience in use of chemical

cartridge respirators as protection

against such hazards.

§ 84.191 Chemical cartridge respirators;

required components.

(a) Each chemical cartridge respirator

described in § 84.190 shall, where its

design requires, contain the following

component parts:

(1) Facepiece, mouthpiece, and

noseclip, hood, or helmet;

(2) Cartridge;

(3) Cartridge with filter;

(4) Harness;

(5) Breathing tube; and

(6) Attached blower.

(b) The components of each chemical

cartridge respirator shall meet the

minimum construction requirements set

forth in subpart G of this part.

§ 84.192 Cartridges in parallel; resistance

requirements.

Where two or more cartridges are

used in parallel, their resistance to

airflow shall be essentially equal.

§ 84.193 Cartridges; color and markings;

requirements.

The color and markings of all

cartridges or labels shall conform with

the requirements of the American

National Standards Institute, American

National Standard for Identification of

Air-Purifying Respirator Canisters and

Cartridges, ANSI K13.1–1973. ANSI

K13.1 is incorporated by reference and

has been approved by the Director of the

Federal Register in accordance with 5

U.S.C. 552(a) and 1 CFR part 51. Copies

may be obtained from American
30384 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

National Standards Institute, Inc., 1430

Broadway, New York, NY 10018. Copies

may be inspected at the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888, or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC.

§ 84.194 Filters used with chemical

cartridges; location; replacement.

(a) Particulate matter filters used in

conjunction with a chemical cartridge

shall be located on the inlet side of the

cartridge.

(b) Filters shall be incorporated in or

firmly attached to the cartridge and each

filter assembly shall, where applicable,

be designed to permit its easy removal

from and replacement on the cartridge.

§ 84.195 Breathing tubes; minimum

requirements.

Flexible breathing tubes used in

conjunction with respirators shall be

designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces,

mouthpieces, hoods, or helmets;

(c) Interference with the wearer’s

activities; and

(d) Shutoff of airflow due to kinking,

or from chin or arm pressure.

§ 84.196 Harnesses; installation and

construction; minimum requirements.

(a) Each respirator shall, where

necessary, be equipped with a suitable

harness designed and constructed to

hold the components of the respirator in

position against the wearer’s body.

(b) Harnesses shall be designed and

constructed to permit easy removal and

replacement of respirator parts and,

where applicable, provide for holding a

full facepiece in the ready position

when not in use.

§ 84.197 Respirator containers; minimum

requirements.

Respirators shall be equipped with a

substantial, durable container bearing

markings which show the applicant’s

name, the type and commercial

designation of the respirator it contains

and all appropriate approval labels.

§ 84.198 Half-mask facepieces, full

facepieces, mouthpieces, hoods, and

helmets; fit; minimum requirements.

(a) Half-mask facepieces and full

facepieces shall be designed and

constructed to fit persons with various

facial shapes and sizes either:

(1) By providing more than one

facepiece size; or

(2) By providing one facepiece size

which will fit varying facial shapes and

sizes.

(b) Hoods and helmets shall be

designed and constructed to fit persons

with various head sizes, provide for the

optional use of corrective spectacles or

lenses, and insure against any

restriction of movement by the wearer.

(c) Mouthpieces shall be equipped

with noseclips which are securely

attached to the mouthpiece or respirator

and provide an airtight fit.

(d) Full facepieces shall provide for

optional use of corrective spectacles or

lenses which shall not reduce the

respiratory protective qualities of the

respirator.

(e) Facepieces, hoods, and helmets

shall be designed to prevent eyepiece

fogging.

§ 84.199 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

Facepieces, hoods, and helmets shall

be designed and constructed to provide

adequate vision which is not distorted

by the eyepieces.

§ 84.200 Inhalation and exhalation valves;

minimum requirements.

(a) Inhalation and exhalation valves

shall be provided where necessary and

protected against distortion.

(b) Inhalation valves shall be designed

and constructed to prevent excessive

exhaled air from entering cartridges or

adversely affecting canisters.

(c) Exhalation valves shall be—

(1) Protected against damage and

external influence; and

(2) Designed and constructed to

prevent inward leakage of contaminated

air.

§ 84.201 Head harnesses; minimum

requirements.

(a) (1) Facepieces for chemical

cartridge respirators other than singleuse vinyl chloride shall be equipped

with adjustable and replaceable head

harnesses designed and constructed to

provide adequate tension during use

and an even distribution of pressure

over the entire area in contact with the

face.

(2) Facepieces for single-use vinyl

chloride respirators shall be equipped

with adjustable head harnesses designed

and constructed to provide adequate

tension during use and an even

distribution of pressure over the entire

area in contact with the face.

(b) Mouthpieces shall be equipped

where applicable, with an adjustable

and replaceable harness designed and

constructed to hold the mouthpiece in

place.

§ 84.202 Air velocity and noise levels;

hoods and helmets; minimum

requirements.

Noise levels generated by the

respirator will be measured inside the

hood or helmet at maximum airflow

obtainable and shall not exceed 80 dBA.

§ 84.203 Breathing resistance test;

minimum requirements.

(a) Resistance to airflow will be

measured in the facepiece, mouthpiece,

hood, or helmet of a chemical cartridge

respirator mounted on a test fixture with

air flowing at a continuous rate of 85

liters per minute, both before and after

each test conducted in accordance with

§§ 84.206 through 84.207.

(b) The maximum allowable

resistance requirements for chemical

cartridge respirators are as follows:

MAXIMUM RESISTANCE

[Millimeter water column height]

Type of chemical-cartridge respirator

Inhalation

Exhalation

Initial Final1

Other than single-use vinyl chloride respirators:

For gases, vapors, or gases and vapors .......................................................................................... 40 45 20

For gases, vapors, or gases and vapors, and particulates .............................................................. 50 70 20

Single-use respirator with valves:

For vinyl chloride ............................................................................................................................... 20 25 20

For vinyl chloride and particulates .................................................................................................... 30 45 2

Single-use respirator without valves:

For vinyl chloride ............................................................................................................................... 15 20 (2)

For vinyl chloride and particulates .................................................................................................... 25 40 (2)

1 Measured at end of service life specified in Table 11 of this subpart.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30385

2Same as inhalation.

§ 84.204 Exhalation valve leakage test;

minimum requirements.

(a) Dry exhalation valves and valve

seats will be subjected to a suction of 25

mm. water-column height while in a

normal operating position.

(b) Leakage between the valve and

valve seat shall not exceed 30 milliliters

per minute.

§ 84.205 Facepiece test; minimum

requirements.

(a) The complete chemical cartridge

respirator will be fitted to the faces of

persons having varying facial shapes

and sizes.

(b) Where the applicant specifies a

facepiece size or sizes for the respirator

together with the approximate

measurement of faces they are designed

to fit, the Institute will provide test

subjects to suit such facial

measurements.

(c) Any chemical cartridge respirator

part which must be removed to perform

the facepiece or mouthpiece fit test shall

be replaceable without special tools and

without disturbing facepiece or

mouthpiece fit.

(d) The facepiece or mouthpiece fit

test using the positive or negative

pressure recommended by the applicant

and described in his instructions will be

used before each test.

(e) (1) Each wearer will enter a

chamber containing 100 p.p.m. isoamyl

acetate vapor for half-mask facepieces,

and 1,000 p.p.m. for full facepieces,

mouthpieces, hoods, and helmets.

(2) The facepiece or mouthpiece may

be adjusted, if necessary, in the test

chamber before starting the test.

(3) Each wearer will remain in the

chamber for 8 minutes while performing

the following activities:

(i) Two minutes, nodding and turning

head;

(ii) Two minutes, calisthenic arm

movements;

(iii) Two minutes, running in place;

and

(iv) Two minutes, pumping with a tire

pump into a 28-liter (1 cubic-foot)

container.

(4) Each wearer shall not detect the

odor of isoamyl-acetate vapor during the

test.

§ 84.206 Particulate tests; respirators with

filters; minimum requirements; general.

(a) Three respirators with cartridges

containing, or having attached to them,

filters for protection against particulates

will be tested in accordance with the

provisions of § 84.207.

(b) In addition to the test

requirements set forth in paragraph (a)

of this section, three such respirators

will be tested, as appropriate, in

accordance with the provisions of

§§ 84.179 through 84.183; however, the

maximum allowable resistance of

complete particulate, and gas, vapor, or

gas and vapor chemical cartridge

respirators shall not exceed the

maximum allowable limits set forth in

§ 84.203.

§ 84.207 Bench tests; gas and vapor tests;

minimum requirements; general.

(a) Bench tests will be made on an

apparatus that allows the test

atmosphere at 50±5 percent relative

humidity and room temperature,

approximately 25 °C, to enter the

cartridges continuously at

predetermined concentrations and rates

of flow, and that has means for

determining the test life of the

cartridges.

(b) Where two cartridges are used in

parallel on a chemical cartridge

respirator, the bench test will be

performed with the cartridges arranged

in parallel, and the test requirements

will apply to the combination rather

than to the individual cartridges.

(c) Three cartridges or pairs of

cartridges will be removed from

containers and tested as received from

the applicant.

(d) Two air purifying cartridges or

pairs of cartridges will be equilibrated at

room temperature by passing 25 percent

relative humidity air through them at

the flow rate of 25 liters per minute

(l.p.m.) for 6 hours.

(e) Two air purifying cartridges or

pairs of cartridges will be equilibrated

by passing 85 percent relative humidity

air through them at the flow rate of 25

l.p.m.

(f) All cartridges will be resealed, kept

in an upright position, at room

temperatures, and tested within 18

hours.

(g) Cartridges will be tested and shall

meet the minimum requirements set

forth in Table 11 of this subpart.

Tables to Subpart L of Part 84

TABLES 9 AND 10 [RESERVED]

TABLE 11–CARTRIDGE BENCH TESTS AND REQUIREMENTS

[42 CFR part 84, subpart L]

Cartridge Test condition

Test atmosphere

Flowrate

(l.p.m.)

Number of

tests

Penetration 1

(p.p.m.)

Minimum

life 2 (min.) Gas or vapor Concentration (p.p.m.)

Ammonia ....................... As received ................... NH3 1000 64 3 50 50

Ammonia ....................... Equilibrated ................... NH3 1000 32 4 50 50

Chlorine ......................... As received ................... Cl2 500 64 3 5 35

Chlorine ......................... Equilibrated ................... Cl2 500 32 4 5 35

Hydrogen chloride ......... As received ................... HCl 500 64 3 5 50

Hydrogen chloride ......... Equilibrated ................... HCl 500 32 4 5 50

Methylamine .................. As received ................... CH3NH2 1000 64 3 10 25

Methylamine .................. Equilibrated ................... CH3NH2 1000 32 4 10 25

Organic vapors .............. As received ................... CCl4 1000 64 3 5 50

Organic vapors .............. Equilibrated ................... CCl4 1000 32 4 5 50

Sulfur dioxide ................. As received ................... SO2 500 64 3 5 30

Sulfur dioxide ................. Equilibrated ................... SO2 500 32 4 5 30

1 Minimum life will be determined at the indicated penetration.
30386 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

2Where a respirator is designed for respiratory protection against more than one type of gas or vapor, as for use in ammonia and in chlorine,

the minimum life shall be one-half that shown for each type of gas or vapor. Where a respirator is designed for respiratory protection against

more than one gas of a type, as for use in chlorine and sulfur dioxide, the stated minimal life shall apply.

Subpart M—[Reserved]

Subpart N—Special Use Respirators

§ 84.250 Vinyl chloride respirators;

description.

Vinyl chloride respirators, including

all completely assembled respirators

which are designed for use as

respiratory protection during entry into

and escape from vinyl chloride

atmospheres containing adequate

oxygen to support life, are described

according to their construction as

follows:

(a) Front-mounted or back-mounted

gas masks;

(b) Chin-style gas masks;

(c) Chemical-cartridge respirators;

(d) Powered air-purifying respirators;

and

(e) Other devices, including

combination respirators.

§ 84.251 Required components.

(a) Each vinyl chloride respirator

described in § 84.250 shall, where its

design requires, contain the following

component parts:

(1) Facepiece;

(2) Canister with end-of-service-life

indicator;

(3) Cartridge with end-of-service-life

indicator;

(4) Harness;

(5) Attached blower; and

(6) Breathing tube.

(b) The components of each vinyl

chloride respirator shall meet the

minimum construction requirements set

forth in Subpart G of this part.

§ 84.252 Gas masks; requirements and

tests.

(a) Except for the tests prescribed in

§ 84.126, the minimum requirements

and performance tests for gas masks,

prescribed in Subpart I of this part, are

applicable to vinyl chloride gas masks.

(b) The following bench tests are

applicable to canisters designed for use

with gas masks for entry into and escape

from vinyl chloride atmospheres

containing adequate oxygen to support

life:

(1) Four canisters will be equilibrated

at 25±5 °C by passing 85±5 percent

relative humidity air through them at 64

liters per minute for six hours.

(2) The equilibrated canisters will be

resealed, kept in an upright position at

room temperature, and tested according

to paragraph (b)(3) of this section within

18 hours.

(3) The canisters equilibrated and

stored as described in paragraphs (b) (1)

and (2) of this section will be tested on

an apparatus that allows the test

atmosphere at 85±5 percent relative

humidity and 25±5 °C to enter the

canister continuously at a concentration

of 25 ppm vinyl chloride monomer at a

total flow rate of 64 liters per minute.

(4) The maximum allowable

penetration after six hours of testing

according to paragraph (b)(3) of this

section shall not exceed 1 ppm vinyl

chloride.

(c) Where canisters are submitted for

testing and approval with a service life

of more than four hours, the period of

time for testing for vinyl chloride

penetration will be performed at 150%

of the service life specified in the

manufacturer’s application. (Example: If

a manufacturer requests approval of a

respirator for six hours use against

exposure to vinyl chloride, the

maximum allowable penetration after

nine hours of testing shall not exceed 1

ppm vinyl chloride.)

§ 84.253 Chemical-cartridge respirators;

requirements and tests.

(a) Except for the tests prescribed in

§§ 84.206 and 84.207, the minimum

requirements and performance tests for

chemical-cartridge respirators

prescribed in Subpart L of this part are

applicable to replaceable-cartridge and

single-use vinyl chloride chemicalcartridge respirators.

(b) The following bench tests are

applicable to cartridges designed for use

with chemical-cartridge respirators for

entry into and escape from vinyl

chloride atmospheres containing

adequate oxygen to support life:

(1) Where two cartridges are used in

parallel on a chemical-cartridge

respirator, the bench test requirements

will apply to the combination rather

than the individual cartridges.

(2) Four cartridges or pairs of

cartridges will be equilibrated at 25±5

°C by passing 85±5 percent relative

humidity air through them at 25 liters

per minute for six hours.

(3) The equilibrated cartridges will be

resealed, kept in an upright position, at

room temperature, and tested according

to paragraphs (b)(4) and (b)(5) of this

section for other than single-use

respirators or according to paragraphs

(b)(6) and (b)(7) of this section for

single-use respirators within 18 hours.

(4) The cartridges or pairs of

cartridges for other than single-use

respirators, equilibrated and stored as

described in paragraphs (b)(1), (b)(2),

and (b)(3) of this section, will be tested

on an apparatus that allows the test

atmosphere at 85±5 percent relative

humidity and 25±5 °C, to enter the

cartridges or pairs of cartridges

continuously at a concentration of 10

ppm vinyl chloride monomer at a total

flowrate of 64 liters per minute.

(5) The maximum allowable

penetration after 90 minutes testing of

cartridges or pairs of cartridges for other

than single-use respirators, according to

paragraph (b)(4) of this section shall not

exceed 1 ppm vinyl chloride.

(6) The single-use respirators,

equilibrated and stored as described in

paragraphs (b)(2) and (b)(3) of this

section, will be tested on an apparatus

that allows a test atmosphere at 85±5

percent relative humidity and 25±5 °C

to be cycled through the respirator by a

breathing machine at a concentration of

10 ppm vinyl chloride monomer at the

rate of 24 respirations per minute at a

minute volume of 40±0.6 liters. Air

exhaled through the respirator will be

35±2 °C with 94±3 percent relative

humidity.

(7) The maximum allowable

penetration after 144 minutes testing of

respirators, according to paragraph

(b)(6) of this section, shall not exceed 1

ppm vinyl chloride.

§ 84.254 Powered air-purifying respirators;

requirements and tests.

(a) Except for the tests prescribed in

§ 84.207, the minimum requirements

and performance tests for powered airpurifying respirators prescribed in

subpart L of this part are applicable to

vinyl chloride powered air-purifying

respirators.

(b) The following bench tests are

applicable to cartridges designed for use

with powered air-purifying respirators

for entry into and escape from vinyl

chloride atmospheres containing

adequate oxygen to support life:

(1) Four cartridges will be

equilibrated at 25± °C by passing 85±5

percent relative humidity air through

them at 115 liters per minute for tightfitting facepieces and 170 liters per

minute for loose-fitting hoods and

helmets, for six hours.

(2) The equilibrated cartridges will be

resealed, kept in an upright position at

room temperature and tested according

to paragraph (b)(3) of this section within

18 hours.

(3) The cartridges equilibrated and

stored as described in paragraphs (b) (1)

and (2) of this section will be tested on

an apparatus that allows the test

atmosphere at 85±5 percent relative
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30387

humidity and 25±5 °C to enter the

cartridge continuously at a

concentration of 25 ppm vinyl chloride

monomer at a total flow rate of 115 liters

per minute for tight-fitting facepieces

and 170 liters per minute for loosefitting hoods and helmets.

(4) The maximum allowable

penetration after six hours of testing

according to paragraph (b)(3) of this

section shall not exceed 1 ppm vinyl

chloride.

§ 84.255 Requirements for end-of-servicelife indicator.

(a) Each canister or cartridge

submitted for testing and approval in

accordance with §§ 84.252, 84.253, and

84.254 shall be equipped with a canister

or cartridge end-of-service-life indicator

which shows a satisfactory indicator

change or other obvious warning before

1 ppm vinyl chloride penetration

occurs. The indicator shall show such

change or afford such warning at 80±10

percent of the total service life to 1 ppm

leakage, as determined by continuing

each test described in §§ 84.252(b),

84.253(b), and 84.254(b) until a 1 ppm

leakage of vinyl chloride occurs.

(b) The applicant shall provide

sufficient pretest data to verify the

performance of the end-of-service-life

indicator required in paragraph (a) of

this section.

§ 84.256 Quality control requirements.

(a) In addition to the construction and

performance requirements specified in

§§ 84.251, 84.252, 84.253, 84.254, and

84.255, the quality control requirements

in paragraphs (b), (c), and (d) of this

section apply to approval of gas masks,

chemical cartridge respirators, and

powered air-purifying respirators for

entry into and escape from vinyl

chloride atmospheres containing

adequate oxygen to support life.

(b) The respirators submitted for

approval as described in paragraph (a)

of this section shall be accompanied by

a complete quality control plan meeting

the requirements of subpart E of this

part.

(c) (1) The applicant shall specify in

the plan that a sufficient number of

samples will be drawn from each bulk

container of sorbent material and that

where activated carbon is used, the

following specific tests will be

performed:

(i) Apparent density;

(ii) Iodine number;

(iii) Moisture content;

(iv) Carbon tetrachloride number; and

(v) Mesh size.

(2) The tests in paragraph (c)(1) of this

section shall be performed in a quantity

necessary to assure continued

satisfactory conformance of the canisters

and cartridges to the requirements of

this subpart.

(d) Final performance quality control

tests on the complete canisters and

cartridges shall be accomplished using

the bench tests and procedures

prescribed in §§ 84.252, 84.253, 84.254,

and 84.255.

§ 84.257 Labeling requirements.

(a) A warning shall be placed on the

label of each gas mask, chemicalcartridge respirator, and powered airpurifying respirator, and on the label of

each canister and cartridge, alerting the

wearer to the need for a fitting test in

accordance with the manufacturer’s

facepiece fitting instructions, providing

service life information, providing

specific instructions for disposal, and

advising that the wearer may

communicate to NIOSH any difficulties

that may be experienced in the design

and performance of any gas mask,

chemical-cartridge respirator, or

powered air-purifying respirator

approved under the requirements of this

subpart. The service lives of respirators

meeting the test requirements of this

subpart shall be specified as follows:

Chemical-cartridge respirator...............1 hour.

Gas mask ..............................................4 hours.

Powered air-purifying respirator ........4 hours.

(b) Where the service life of a

respirator is approved for more than

four hours, the service life for which the

respirator has been approved will be

specified.

§ 84.258 Fees.

The following fees shall be charged

for the examination, inspection, and

testing of complete assemblies and

components of respirators described in

§§ 84.250 and 84.251:

Complete gas mask.................................$1,100

Complete chemical-cartridge

respirator.......................................... 1,150

Complete powered air-purifying

respirator.......................................... 1,500

Canister or cartridge only....................... 750

Subparts O through JJ [Reserved]

Subpart KK—Dust, Fume, and Mist;

Pesticide; Paint Spray; Powered AirPurifying High Efficiency Respirators

and Combination Gas Masks

§ 84.1100 Scope and effective dates.

The purpose of this subpart KK is to

establish procedures and requirements

for issuing extensions of approval of

particulate respirators certified prior to

July 10, 1995 under the provisions of 30

CFR part 11 (See 30 CFR part 11 edition,

as revised July 1, 1994.), new approvals

and extensions of approval of

particulate respirators for applications

that are in NIOSH receipt on July 10,

1995, and approval of powered airpurifying respirators.

(a) Air-purifying respirators with

particulate filters approved under the

provisions of this subpart after July 10,

1995 will have a 30 CFR part 11

approval label.

(b) Only changes or modifications of

non-powered air-purifying respirators

with particulate filters approved under

the provisions of subparts I, K, L, or M

of 30 CFR part 11 or paragraph (a) of

this section and deemed necessary by

NIOSH to ensure the health and safety

of the wearer will be approved until July

10, 1998 and will have a 30 CFR part 11

approval label.

(c) Only changes or modifications of

powered air-purifying respirators with

particulate filters approved under the

provisions of subparts I, K, L, or M of

30 CFR part 11 or paragraph (a) of this

section and deemed necessary by

NIOSH to ensure the health and safety

of the wearer will be approved under

this subpart until July 10, 1998 and will

have a 30 CFR part 11 label.

(d) Approval of powered air-purifying

respirators will be issued under this

subpart. Particulate filters for powered

air-purifying respirators approved under

the provisions of this subpart shall be

only high-efficiency (HEPA) as

described in § 84.1130(a)(4) and will

carry a 42 CFR part 84 approval label.

In addition, changes or modifications of

powered HEPA air-purifying respirators

approved under the provisions of this

subpart KK will be approved under this

subpart and will have a 42 CFR part 84

approval label.

§ 84.1101 Definitions.

As used in this subpart

(a) Air Contamination Level means

the standards of contaminant levels

prescribed by the Secretary of Labor in

accordance with the provisions of the

Occupational Safety and Health Act of

1970 (Pub. L. 91–596; 84 Stat. 1590).

(b) DOP means a homogenous liquid

aerosol, having a particle diameter of 0.3

micrometer, which is generated by

vaporization and condensation of

dioctyl phthalate.

(c) Pesticide means:

(1) Any substance or mixture of

substances (including solvents and

impurities) intended to prevent, destroy,

repel, or mitigate any insect, rodent,

nematode, fungus, weed, or other form

of plant or animal life or virus; and

(2) Any substance or mixture of

substances (including solvents and

impurities) intended for use as a plant

regulator, defoliant, or desiccant, as

defined in the Federal Insecticide,
30388 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

Fungicide, and Rodenticide Act of 1947,

as amended (7 U.S.C. 135–135k),

excluding fumigants which are applied

as gases or vapors or in a solid or liquid

form as pellets or poured liquids for

subsequent release as gases or vapors.

(d) Radionuclide means an atom

identified by the constitution of its

nucleus (specified by the number of

protons Z, number of neutrons N, and

energy, or, alternatively, by the atomic

number Z, mass number A=(N+Z), and

atomic mass) which exists for a

measurable time; decays or disintegrates

spontaneously, emits radiation, and

results in the formation of new nuclides.

(e) Smoke means the products of

incomplete combustion of organic

substances in the form of solid and

liquid particles and gaseous products in

air, usually of sufficient concentration

to perceptibility obscure vision.

§ 84.1102 Examination, inspection and

testing of complete respirator assemblies;

fees.

The following fees shall be charged by

the Institute for the examination,

inspection and testing of complete

respirator assemblies approved under

this subpart:

(a) Gas masks with particulate filter,

including pesticide gas masks—

(1) Single hazard—$1,100.

(2) Type N—$4,100.

(b) Dust, fume and mist respirators—

(1) Single particulate hazard having

an Air Contamination Level more than

0.05 mg./m.3 or 2 million particles per

cubic foot—$500.

(2) Combination particulate hazards

having an Air Contamination Level

more than 0.05 mg./m.3 or 2 million

particles per cubic foot—$750.

(3) Particulate hazards having an Air

Contamination Level less than 0.05 mg./

m.3 or 2 million particles per cubic foot,

radon daughters —$1,250.

(4) All dusts, fumes and mists—

$2,000.

(c) Paint spray respirators—$1,600.

(d) Pesticide respirators—$1,600.

(e) Chemical cartridge respirators with

particulate filter—$1,150.

§ 84.1103 Approval labels and markings;

approval of contents; use.

(a) Full-scale reproductions of

approval labels and markings, and a

sketch or description of the method of

application and position on the harness,

container, canister, cartridge, filter, or

other component, together with

instructions for the use and

maintenance of the respirator shall be

submitted to MSHA and the Institute for

approval.

(b) Approval labels for non-powered

and powered air-purifying dust, fume,

mist respirators approved prior to July

10, 1995 under the provisions of subpart

K of 30 CFR part 11 (See 30 CFR Part

11 edition, revised as of July 1, 1994.)

shall bear the emblem of the Mine

Safety and Health Administration and

the seal of the Department of Health and

Human Services, the applicant’s name

and address, an approval number

assigned by the Institute, a statement

that the respirator was tested and

approved under subpart K of 30 CFR

part 11 and, where appropriate,

restrictions or limitations placed upon

the use of the respirator by the Institute.

The approval number assigned by the

Institute shall be designated by the

prefix TC and a serial number.

(c) Approval labels for powered airpurifying respirators approved under

the provisions of this subpart shall bear

the emblem of the National Institute for

Occupational Safety and Health and the

seal of the Department of Health and

Human Services, the applicant’s name

and address, an approval number

assigned by the Institute, a statement

stating the respirator was tested under

the provisions of this subpart, and,

where appropriate, restrictions or

limitations placed upon the use of the

respirator by the Institute. The approval

number assigned by the Institute shall

be designated by the prefix TC and a

serial number.

(c) The Institute shall, where

necessary, notify the applicant when

additional labels, markings, or

instructions will be required.

(d) Approval labels and markings

shall only be used by the applicant to

whom they were issued.

(e) Legible reproductions or

abbreviated forms of the label approved

by the Institute for use on each

respirator shall be attached to or printed

at the following locations:

Respirator type Label type Location

Gas mask with a particulate filter, including pesticide

gas mask.

Entire .................................. Mask and container.

Dust, fume, and mist respirators ...................................... Entire .................................. Respirator container and filter container.

Abbreviated ......................... Filters.

Chemical-cartridge respirator with a particulate filter, including paint spray respirator.Entire .................................. Respirator container, cartridge container, and filter containers (where applicable).

Abbreviated ......................... Cartridges and filters and filter containers.

Pesticide respirator .......................................................... Entire .................................. Respirator container, and cartridge and filter containers.

Abbreviated ......................... Cartridges and filters.

(f) The use of any MSHA and Institute

approval label obligates the applicant to

whom it is issued to maintain or cause

to be maintained the approved quality

control sampling schedule and the

acceptable quality level for each

characteristic tested, and to assure that

it is manufactured according to the

drawings and specifications upon which

the certificate of approval is based.

(g) Each respirator, respirator

component, and respirator container

shall, as required by the Institute to

assure quality control and proper use of

the respirator, be labeled distinctly to

show the name of the applicant, and the

name and letters or numbers by which

the respirator or respirator component is

designated for trade purposes, and the

lot number, serial number, or

approximate date of manufacture.

§ 84.1130 Respirators; description.

(a) Dust, fume, and mist respirators,

including all completely assembled

respirators designed for use as

respiratory protection during entry into

and escape from atmospheres which

contain adequate oxygen to support life

and hazardous particulates, are

described as follows:

(1) Air-purifying respirators, either

with replaceable or reusable filters,

designed as respiratory protection

against dusts:

(i) Having an air contamination level

not less than 0.05 milligram per cubic

meter of air, including but not limited

to coal, arsenic, cadmium, chromium,

lead, and manganese; or

(ii) Having an air contamination level

not less than 2 million particles per

cubic foot of air, including but not

limited to aluminum, flour, iron ore,

and free silica, resulting principally

from the disintegration of a solid, e.g.,

dust clouds produced in mining,
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30389

quarrying, and tunneling, and in dusts

produced during industrial operations,

such as grinding, crushing, and the

general processing of minerals and other

materials.

(2) Air-purifying respirators, with

replaceable filters, designed as

respiratory protection against fumes of

various metals having an air

contamination level not less than 0.05

milligram per cubic meter, including

but not limited to aluminum, antimony,

arsenic, cadmium, chromium, copper,

iron, lead, magnesium, manganese,

mercury (except mercury vapor), and

zinc, which result from the sublimation

or condensation of their respective

vapors, or from the chemical reaction

between their respective vapors and

gases.

(3) Air-purifying respirators, with

replaceable filters, designed as

respiratory protection against mists of

materials having an air contamination

level not less than 0.05 milligram per

cubic meter or 2 million particles per

cubic foot, e.g., mists produced by spray

coating with vitreous enamels, chromic

acid mist produced during chromium

plating, and other mists of materials

whose liquid vehicle does not produce

harmful gases or vapors.

(4) Air-purifying respirators, with

replaceable filters, designed as

respiratory protection against dusts,

fumes, and mists having an air

contamination level less than 0.05

milligram per cubic meter, including

but not limited to lithium hydride and

beryllium, and against radionuclides.

(5) Air-purifying respirators, with

replaceable filters, designed as

respiratory protection against radon

daughters, and radon daughters attached

to dusts, fumes, and mists.

(6) Air-purifying respirators, with

replaceable filters, designed as

respiratory protection against asbestoscontaining dusts and mists.

(7) Air-purifying respirators, with

replaceable filters, designed as

protection against various combinations

of particulate matter.

(8) Air-purifying dust respirators

designed as respiratory protection

against pneumoconiosis- and fibrosisproducing dusts, or dusts and mists,

including but not limited to aluminum,

asbestos, coal, flour, iron ore, and free

silica.

(b) Gas masks containing filters for

protection against dusts, fumes, mists,

and smokes in combination with gases,

vapors, or gases and vapors. These

respirators are not for use against gases

or vapors with poor warning properties

(except where MSHA or Occupational

Safety and Health Administration

standards may permit such use for a

specific gas or vapor) or those which

generate high heats of reaction with

sorbent material in the canister.

(c) Pesticide respirators, including all

completely assembled respirators which

are designed for use as respiratory

protection during entry into and escape

from atmospheres which contain

pesticide hazards, are described

according to their construction as

follows:

(1) Front-mounted or back-mounted

gas masks;

(2) Chin-style gas mask;

(3) Chemical cartridge;

(4) Air-purifying respirator with

attached blower; and,

(5) Other devices, including

combination respirators.

(d) Respirators with cartridges

containing or having attached to them,

filters for protection against mists of

paints, lacquers, and enamels. These

respirators are not for use against gases

or vapors with poor warning properties

(except where MSHA or Occupational

Safety and Health Administration

standards may permit such use for a

specific gas or vapor) or those which

generate high heats of reaction with

sorbent material in the cartridge.

(e) Respirators with cartridges

containing or having attached to them

filters for protection against dusts,

fumes, and mists, except the mists of

paints, lacquers, and enamels. These

respirators are not for use against gases

or vapors with poor warning properties

(except where MSHA or Occupational

Safety and Health Administration

standards may permit such use for a

specific gas or vapor) or those which

generate high heats of reaction with

sorbent material in the cartridge.

§ 84.1131 Respirators; required

components.

(a) Each respirator described in

§ 84.1130 shall, where its design

requires, contain the following

component parts:

(1) Facepiece, mouthpiece with

noseclip, hood, or helmet;

(2) Filter unit, canister with filter, or

cartridge with filter;

(3) Harness;

(4) Attached blower; and

(5) Breathing tube.

(b) The components of each respirator

shall meet the minimum construction

requirements set forth in Subpart G of

this part.

§ 84.1132 Breathing tubes; minimum

requirements.

(a) Flexible breathing tubes used in

conjunction with respirators shall be

designed and constructed to prevent:

(1) Restriction of free head movement;

(2) Disturbance of the fit of facepieces,

mouthpieces, hoods, or helmets;

(3) Interference with the wearer’s

activities; and

(4) Shutoff of airflow due to kinking,

or from chin or arm pressure.

§ 84.1133 Harnesses; installation and

construction; minimum requirements.

(a) Each respirator shall, where

necessary, be equipped with a suitable

harness designed and constructed to

hold the components of the respirator in

position against the wearer’s body.

(b) Harnesses shall be designed and

constructed to permit easy removal and

replacement of respirator parts, and,

where applicable, provide for holding a

full facepiece in the ready position

when not in use.

§ 84.1134 Respirator containers; minimum

requirements.

(a) Except as provided in paragraph

(b) of this section each respirator shall

be equipped with a substantial, durable

container bearing markings which show

the applicant’s name, the type of

respirator it contains, and all

appropriate approval labels. Except for

dust, fume, and mist respirators, the

commercial designation of the respirator

it contains shall be shown.

(b) Containers for single-use

respirators may provide for storage of

more than one respirator, however, such

containers shall be designed and

constructed to prevent contamination of

respirators which are not removed, and

to prevent damage to respirators during

transit.

(c) Containers for gas masks

combinations shall be designed and

constructed to permit easy removal of

the mask.

§ 84.1135 Half-mask facepieces, full

facepieces, hoods, helmets, and

mouthpieces; fit; minimum requirements.

(a) Half-mask facepieces and full

facepieces shall be designed and

constructed to fit persons with various

facial shapes and sizes either:

(1) By providing more than one

facepiece size; or

(2) By providing one facepiece size

which will fit varying facial shapes and

sizes.

(b) Full facepieces shall provide for

optional use of corrective spectacles or

lenses, which shall not reduce the

respiratory protective qualities of the

respirator.

(c) Hoods and helmets shall be

designed and constructed to fit persons

with various head sizes, provide for the

optional use of corrective spectacles or

lenses, and insure against any

restriction of movement by the wearer.
30390 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

(d) Mouthpieces shall be equipped

with noseclips which are securely

attached to the mouthpiece or respirator

and provide an airtight seal.

(e) Facepieces, hoods, and helmets

shall be designed to prevent eyepiece

fogging.

(f) Half-mask facepieces shall not

interfere with the fit of common

industrial safety corrective spectacles,

as determined by the Institute’s

facepiece tests in §§ 84.1141, 84.1142,

and 84.1156(b).

§ 84.1136 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

(a) Facepieces, hoods, and helmets

shall be designed and constructed to

provide adequate vision which is not

distorted by the eyepieces.

(b) All eyepieces of gas masks

combinations shall be designed and

constructed to be impact and

penetration resistant. Federal

Specification, Mask, Air Line: and

Respirator, Air Filtering, Industrial,

GGG–M–125d, October 11, 1965, with

interim amendment-1, July 30, 1969, is

an example of an appropriate standard

for determining impact and penetration

resistance. Copies of GGG–M–125d may

be obtained from the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888.

§ 84.1137 Inhalation and exhalation valves;

minimum requirements.

(a) Inhalation and exhalation valves

shall be protected against distortion.

(b) Inhalation valves shall be designed

and constructed and provided where

necessary to prevent excessive exhaled

air from adversely affecting filters,

cartridges, and canisters, except where

filters of dust, fume, and mist

respirators are specifically designed to

resist moisture as prescribed in

§ 84.1145.

(c) Exhalation valves shall be:

(1) Provided where necessary;

(2) Protected against damage and

external influence; and

(3) Designed and constructed to

prevent inward leakage of contaminated

air.

§ 84.1138 Head harnesses; minimum

requirements.

(a) All facepieces shall be equipped

with head harnesses designed and

constructed to provide adequate tension

during use and an even distribution of

pressure over the entire area in contact

with the face.

(b) Facepiece head harnesses, except

those employed on single-use dust,

fume, and mist respirators, shall be

adjustable and replaceable.

(c) Mouthpieces shall be equipped,

where applicable, with adjustable and

replaceable harnesses, designed and

constructed to hold the mouthpiece in

place.

§ 84.1139 Air velocity and noise levels;

hoods and helmets; minimum

requirements.

Noise levels generated by the

respirator will be measured inside the

hood or helmet at maximum airflow

obtainable and shall not exceed 80 dBA.

§ 84.1140 Dust, fume, and mist respirators;

performance requirements; general.

Dust, fume, and mist respirators and

the individual components of each such

device shall, as appropriate, meet the

requirements for performance and

protection specified in the tests

described in §§ 84.1141 through 84.1152

and prescribed in Tables 12 and 13.

§ 84.1141 Isoamyl acetate tightness test;

dust, fume, and mist respirators designed

for respiratory protection against fumes of

various metals having an air contamination

level not less than 0.05 milligram per cubic

meter; minimum requirements.

(a) The respirator will be modified in

such a manner that all of the air that

normally would be inhaled through the

inhalation port(s) is drawn through an

efficient activated charcoal-filled

canister, or cartridge(s), without

interference with the face-contacting

portion of the facepiece.

(b) The modified respirator will be

worn by persons for at least 2 minutes

each in a test chamber containing 100

parts (by volume) of isoamyl-acetate

vapor per million parts of air.

(c) The odor of isoamyl-acetate shall

not be detected by the wearers of the

modified respirator while in the test

atmosphere.

§ 84.1142 Isoamyl acetate tightness test;

respirators designed for respiratory

protection against dusts, fumes, and mists

having an air contamination level less than

0.05 milligram per cubic meter, or against

radionuclides; minimum requirements.

(a) The applicant shall provide a

charcoal-filled canister or cartridge of a

size and resistance similar to the filter

unit with connectors which can be

attached to the facepiece in the same

manner as the filter unit.

(b)(1) The canister or cartridge will be

used in place of the filter unit, and

persons will each wear a modified halfmask facepiece for 5 minutes in a test

chamber containing 100 parts (by

volume) of isoamyl-acetate vapor per

million parts of air.

(2) The following work schedule will

be performed by each wearer in the test

chamber:

(i) Two minutes walking, nodding,

and shaking head in normal movements;

and

(ii) Three minutes exercising and

running in place.

(3) The facepiece shall be capable of

adjustment, according to the applicant’s

instructions, to each wearer’s face, and

the odor of isoamyl-acetate shall not be

detectable by any wearer during the test.

(c) Where the respirator is equipped

with a full facepiece, hood, helmet, or

mouthpiece, the canister or cartridge

will be used in place of the filter unit,

and persons will each wear the

modified respiratory-inlet covering for 5

minutes in a test chamber containing

1,000 parts (by volume) of isoamylacetate vapor per million parts of air,

performing the work schedule specified

in paragraph (b)(2) of this section.

§ 84.1143 Dust, fume, and mist airpurifying filter tests; performance

requirements; general.

Dust, fume, and mist respirators will

be tested in accordance with the

schedule set forth in Table 13 of this

subpart to determine their effectiveness

as protection against the particulate

hazards specified in Table 13.

§ 84.1144 Silica dust test for dust, fume,

and mist respirators; single-use or reusable

filters; minimum requirements.

(a) Three non-powered respirators

with single-use filters will be tested for

periods of 90 minutes each at a

continuous airflow rate of 32 liters per

minute.

(b) The relative humidity in the test

chamber will be 20–80 percent, and the

room temperature approximately 25° C.

(c) The test suspension in the

chamber will not be less than 50 nor

more than 60 milligrams of flint (99+

percent free silica) per cubic meter of

air.

(d) The flint in suspension will be

ground to pass 99+ percent through a

270-mesh sieve.

(e) The particle-size distribution of

the test suspension will have a

geometric mean of 0.4 to 0.6

micrometer, and the standard geometric

deviation will not exceed 2.

(f) The total amount of unretained test

suspension in samples taken during

testing shall not exceed 1.5 milligrams

for a non-powered air-purifying

respirator.

(g) Three non-powered respirators

with reusable filters will be tested and

shall meet the requirements specified in

paragraphs (a) through (f) of this section;

each filter shall be tested three times:

Once as received; once after cleaning;

and once after recleaning. The

applicant’s instructions shall be

followed for each cleaning.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30391

§ 84.1145 Silica dust test; non-powered

single-use dust respirators; minimum

requirements.

(a) Three respirators will be tested.

(b) As described in § 84.1144, airflow

will be cycled through the respirator by

a breathing machine at the rate of 24

respirations per minute with a minute

volume of 40 liters; a breathing machine

cam with a work rate of 622 kg.-m.2/

minute shall be used.

(c) Air exhaled through the respirator

will be 35° ±2° C. with 94 ±3 percent

relative humidity. #

(d) Air inhaled through the respirator

will be sampled and analyzed for

respirator leakage.

(e) The total amount of unretained test

suspension, after drying, in samples

taken during testing, shall not exceed

1.8 milligrams for any single test.

§ 84.1146 Lead fume test for dust, fume,

and mist respirators; minimum

requirements.

(a) Three non-powered respirators

will be tested for a period of 312

minutes each at a continuous airflow

rate of 32 liters per minute.

(b) The relative humidity in the test

chamber will be 20–80 percent, and the

room temperature approximately 25° C.

(c) The test suspension in the test

chamber will not be less than 15 nor

more than 20 milligrams of freshly

generated lead-oxide fume, calculated as

lead (Pb), per cubic meter of air.

(d) The fume will be generated by

impinging an oxygen-gas flame on

molten lead.

(e) Samples of the test suspension will

be taken during each test period for

analysis.

(f) The total amount of unretained test

suspension in the samples taken during

testing, which is analyzed and

calculated as lead (Pb), shall not exceed

1.5 milligrams of lead for a nonpowered air-purifying respirator.

§ 84.1147 Silica mist test for dust, fume,

and mist respirators; minimum

requirements.

(a) Three non-powered respirators

will be tested for a period of 312

minutes each at a continuous airflow

rate of 32 liters per minute.

(b) The room temperature in the test

chamber will be approximately 25°C.

(c) The test suspension in the test

chamber will not be less than 20 nor

more than 25 milligrams of silica mist,

weighed as silica dust, per cubic meter

of air.

(d) Mist will be produced by spraying

an aqueous suspension of flint (99+

percent free silica), and the flint shall be

ground to pass 99+ percent through a

270-mesh sieve.

(e) Samples of the test suspension will

be taken during each test period for

analysis.

(f) The total amount of silica mist

unretained in the samples taken during

testing, weighed as silica dust, shall not

exceed 2.5 milligrams for a nonpowered air-purifying respirator.

§ 84.1148 Tests for respirators designed

for respiratory protection against more than

one type of dispersoid; minimum

requirements.

Respirators designed as respiratory

protection against more than one

particulate hazard (dust, fume, or mist)

shall comply with all the requirements

of this part, with respect to each of the

specific hazards involved.

§ 84.1149 Airflow resistance tests; all dust,

fume, and mist respirators; minimum

requirements.

(a) Resistance to airflow will be

measured in the facepiece, mouthpiece,

hood, or helmet of a dust, fume, or mist

respirator mounted on a test fixture with

air flowing at a continuous rate of 85

liters per minute, both before and after

each test conducted in accordance with

§§ 84.1144 through 84.1147.

(b) The maximum allowable

resistance requirements for dust, fume,

and mist respirators are as follows:

MAXIMUM RESISTANCE

[mm. water-column height]

Type of respirator Initial inhalation

Final inhalation Exhalation

Pneumoconiosis- and fibrosis-producing dusts, or dusts and mists ....................................................... 12 15 15

Dust, fume, and mist, with single-use filter .............................................................................................. 30 50 20

Dust, fume, and mist, with reusable filter ................................................................................................ 20 40 20

Radon daughter ....................................................................................................................................... 18 1 25 15

Asbestos dust and mist ............................................................................................................................ 18 25 15

1 Measured after silica dust test described in § 84.1144.

§ 84.1150 Exhalation valve leakage test;

minimum requirements.

(a) Dry exhalation valves and valve

seats will be subjected to a suction of 25

mm. water-column height while in a

normal operating position.

(b) Leakage between the valve and

valve seat shall not exceed 30 milliliters

per minute.

§ 84.1151 DOP filter test; respirators

designed as respiratory protection against

dusts, fumes, and mists having an air

contamination level less than 0.05 milligram

per cubic meter and against radionuclides;

minimum requirements.

(a) All single air-purifying respirator

filter units will be tested in an

atmosphere concentration of 100

micrograms of DOP per liter of air at

continuous flow rates of 32 and 85 liters

per minute for a period of 5 to 10

seconds.

(b) Where filters are to be used in

pairs, the flow rates will be 16 and 42.5

liters per minute, respectively, through

each filter.

(c) The filter will be mounted on a

connector in the same manner as used

on the respirator, and the total leakage

for the connector and filter shall not

exceed 0.03 percent of the ambient DOP

concentration at either flow rate.

§ 84.1152 Silica dust loading test;

respirators designed as protection against

dusts, fumes, and mists having an air

contamination level less than 0.05 milligram

per cubic meter and against radionuclides;

minimum requirements.

(a) Three non-powered respirators

will be tested in accordance with the

provisions of § 84.1144, or equivalent,

and shall meet the minimum

requirements of §§ 84.1144 and 84.1149.

(b) Three powered air-purifying

respirators will be tested in accordance

with the provisions of § 84.1144 except

they will be tested for a period of 4

hours each at a flowrate not less than

115 liters per minute to tight-fitting

facepieces, and not less than 170 liters

per minute to loose-fitting hoods and

helmets. The total amount of unretained

test suspension in samples taken during

testing shall not exceed 14.4 milligrams

for a powered air-purifying respirator

with tight-fitting facepiece, and 21.3

milligrams for a powered air-purifying

respirator with loose-fitting hood or

helmet. They shall meet the minimum

requirements of § 84.1149.
30392 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

§ 84.1153 Dust, fume, mist, and smoke

tests; canister bench tests; gas masks

canisters containing filters; minimum

requirements.

(a) Gas mask canisters containing

filters for protection against dusts,

fumes, mists, and smokes in

combination with gases, vapors, or gases

and vapors, will be tested as prescribed

in § 84.1140 except for the breathing

resistance which will be in accordance

with § 84.122.

(b) Gas mask canisters designed for

protection against smokes will be tested

in an atmospheric concentration of 100

micrograms of dioctyl phthalate per liter

of air at continuous flow rates of 32

liters per minute and 85 liters per

minute for a period of 5 to 10 seconds,

and the DOP leakage through the

canister shall not exceed 0.03 percent of

the test concentration.

(c) Gas mask canisters containing

filters for protection against dusts,

fumes, mists, and smokes in

combination with gases, vapors, or gases

and vapors, will be tested as prescribed

in § 84.126.

§ 84.1154 Canister and cartridge

requirements.

(a) Where two or more canisters or

cartridges are used in parallel, their

resistance to airflow shall be essentially

equal.

(b) The color and markings of all

canisters and cartridges or labels shall

conform with the requirements of the

American National Standards Institute,

American National Standard for

Identification of Air-Purifying

Respirator Canisters and Cartridges,

ANSI K13.1–1973. ANSI K13.1 is

incorporated by reference and has been

approved by the Director of the Federal

Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may

be obtained from American National

Standards Institute, Inc., 1430

Broadway, New York, NY 10018. Copies

may be inspected at the NIOSH,

Certification and Quality Assurance

Branch, 1095 Willowdale Road,

Morgantown, WV 26505–2888, or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC.

§ 84.1155 Filters used with canisters and

cartridges; location; replacement.

(a) Particulate matter filters used in

conjunction with a canister or cartridge

shall be located on the inlet side of the

canister or cartridge.

(b) Filters shall be incorporated into

or firmly attached to the canister or

cartridge and each filter assembly shall,

where applicable, be designed to permit

its easy removal from and replacement

on the canister or cartridge.

§ 84.1156 Pesticide respirators;

performance requirements; general.

Pesticide respirators and the

individual components of each such

device shall, as appropriate, meet the

following minimum requirements for

performance and protection:

(a) Breathing resistance test. (1)

Airflow resistance will be measured in

the facepiece, mouthpiece, hood, or

helmet of a pesticide respirator mounted

on a test fixture with air flowing at a

continuous rate of 85 liters per minute,

both before and after each test

conducted in accordance with

paragraphs (c) and (f) of this section.

(2) The maximum allowable

resistance requirements for pesticide

respirators are as follows:

MAXIMUM RESISTANCE

[mm. water-column height]

Type of pesticide respirator

Inhalation

Exhalation

Initial Final 1

Front- or back-mounted gas mask ........................................................................................................... 70 85 20

Chin-style gas mask ................................................................................................................................. 65 80 20

Powered air-purifying 2 ............................................................................................................................. 2 50 2 70 20

Chemical Cartridge .................................................................................................................................. 50 70 20

1 Measured at end of the service life specified in Table 14 of this subpart.

2 Resistance of filter(s), cartridge(s), and breathing tube(s) only with blower not operating.

(b) Facepiece test. (1) The complete

pesticide respirator will be fitted to the

faces of persons having varying facial

shapes and sizes.

(2) Where the applicant specifies a

facepiece size or sizes for his respirator

together with the approximate

measurements of faces they are designed

to fit, the Institute will provide test

subjects to suit such facial

measurements.

(3) Any pesticide respirator part

which must be removed to perform the

facepiece fit test shall be replaceable

without special tools and without

disturbing facepiece fit.

(4) The facepiece or mouthpiece fit

test using positive or negative pressure

recommended by the applicant and

described in his instructions will be

used during each test.

(5)(i) Each wearer will enter a

chamber containing 1,000 p.p.m.

isoamyl-acetate vapor for a respirator

equipped with a full facepiece,

mouthpiece, hood, or helmet and 100

p.p.m. isoamyl-acetate vapor for a

respirator equipped with a half-mask

facepiece.

(ii) The facepiece, mouthpiece, hood,

or helmet may be adjusted, if necessary,

in the test chamber before starting the

test.

(iii) Each wearer will remain in the

chamber while performing the following

activities:

(A) Two minutes, nodding and

turning head;

(B) Two minutes, calisthenic arm

movements;

(C) Two minutes, running in place;

and

(D) Two minutes, pumping with a tire

pump into a 28-liter (1 cubic foot)

container.

(iv) Each wearer shall not detect the

odor of isoamyl-acetate during the test.

(c) Silica dust test. Three completely

assembled pesticide respirators will be

tested with a mechanical-testing

apparatus as follows:

(1) Temperature in the test chamber

will be approximately 25° C.

(2) Continuous airflow through the

respirator will be 32 liters per minute

for front-mounted, back-mounted, and

chin-style gas mask pesticide respirators

and chemical cartridge pesticide

respirators, and not less than 115 (4

cubic feet) liters per minute to tightfitting facepieces and 170 liters (6 cubic

feet) per minute to loose-fitting hoods

and helmets of powered air-purifying

respirators.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30393

(3) The test aerosol will contain 50–

60 milligrams of 99+ percent free silica

per cubic meter of air.

(4) The particle size distribution of

the test suspension will have a

geometric mean diameter of 0.4 to 0.6

micrometer, with a standard geometric

deviation less than 2.

(5) Front-mounted, back-mounted,

and chin-style gas mask pesticide

respirators and chemical cartridge

pesticide respirators will be tested for

90 minutes and powered air-purifying

respirators will be tested for 4 hours.

(d) Lead fume test. Three completely

assembled pesticide respirators will be

tested with a mechanical-testing

apparatus as follows:

(1) Continuous airflow through the

respirator will be 32 liters per minute

for front-mounted, back-mounted, and

chin-style gas mask pesticide respirators

and chemical cartridge pesticide

respirators and not less than 115 liters

(4 cubic feet) per minute, for powered

air-purifying respirators with tightfitting facepieces, and not less than 170

liters (6 cubic feet) per minute for

powered air-purifying respirators with

loose-fitting hoods and helmets.

(2) The test aerosol will contain 15–

20 milligrams of freshly generated leadoxide fume, calculated as lead, per

cubic meter of air.

(3) The fume will be generated by

impinging an oxygen-gas flame on

molten lead.

(4) Front-mounted, back-mounted,

and chin-style gas mask pesticide

respirators and chemical cartridge

pesticide respirators will be tested for

90 minutes and powered air-purifying

pesticide respirators will be tested for 4

hours.

(5) The total amount of unretained

test suspension, which is analyzed and

calculated as lead, shall not exceed:

(i) 0.43 milligram for any 90-minute

test;

(ii) 4.8 milligrams for any 4-hour test

made at 115 liters (4 cubic feet) per

minute; or

(iii) 6.2 milligrams for any 4-hour test

made at 170 liters (6 cubic feet) per

minute.

(e) Dioctyl-phthalate test. (1) All

canisters submitted for use with frontmounted and back-mounted gas mask

pesticide respirators will be tested in an

atmospheric concentration of 100

micrograms of dioctyl-phthalate per liter

of air at continuous flow rates of 32 and

85 liters per minute for a test period of

5 to 10 seconds.

(2) The DOP leakage through the

canister shall not exceed 0.03 percent of

the ambient DOP concentration.

(f) Bench tests for pesticide

respirators. (1)(i) Bench tests will be

made on an apparatus that allows the

test atmosphere at 50±5 percent relative

humidity and at room temperature

(25°±2.5° C.) to enter the canister or

cartridge at predetermined

concentrations and rates of flow, and

that has a means for determining the test

life of the canister or cartridge against

carbon tetrachloride.

(ii) Canisters and cartridges will be

tested as they are used on each pesticide

respirator, either singly or in pairs.

(iii) Three canisters or cartridges or

pairs of cartridges will be removed from

containers and tested as received from

the applicant.

(iv) Two canisters, cartridges, or pairs

of cartridges will be equilibrated at

room temperature by passing 25 percent

relative humidity air through them at

the following flow rates (expressed as

liters per minute (l.p.m.)) for 6 hours:

Type of canister or cartridge

Airflow

rate,

l.p.m.

Air-purifying canister ..................... 64

Air-purifying cartridge ................... 25

Powered air-purifying with tight-fitting facepiece ............................ 115

Powered air-purifying with loosefitting hood or helmet ................ 170

(v) Two canisters, cartridges, or pairs

of cartridges will be equilibrated at

room temperature by passing 85 percent

relative humidity air through them at

the flow rates stated in paragraph

(f)(1)(iv) of this section for 6 hours.

(vi) The equilibrated canisters or

cartridges will be resealed, kept in an

upright position at room temperature,

and tested within 18 hours.

(2) Canisters and cartridges tested in

accordance with the provisions of this

section shall meet the requirements

specified in Table 14 of this subpart.

§ 84.1157 Chemical cartridge respirators

with particulate filters; performance

requirements; general.

Chemical cartridge respirators with

particulate filters and the individual

components of each such device shall,

as appropriate, meet the following

minimum requirements for performance

and protection:

(a) Breathing resistance test. (1)

Resistance to airflow will be measured

in the facepiece, mouthpiece, hood, or

helmet of a chemical cartridge respirator

mounted on a test fixture with air

flowing at a continuous rate of 85 liters

per minute, both before and after each

test conducted in accordance with

paragraphs (d) through (f) of this

section.

(2) The maximum allowable

resistance requirements for chemical

cartridge respirators are as follows:

MAXIMUM RESISTANCE

[mm. water-column height]

Type of chemical cartridge respirator

Inhalation

Exhalation

Initial Final 1

For gases, vapors, or gases and vapors, and dusts, fumes, and mists ................................................. 50 70 20

For gases, vapors, or gases and vapors, and mists of paints, lacquers, and enamels ......................... 50 70 20

1 Measured at end of service life specified in Table 11 in subpart L of this part.

(b) Facepiece test. The facepiece test

will be conducted as specified in

§ 84.205.

(c) Lacquer and enamel mist tests;

general. (1) Three respirators with

cartridges containing or having attached

to them, filters for protection against

mists of paints, lacquers, and enamels

shall be tested in accordance with the

provisions of paragraph (f) of this

section.

(2) In addition to the test

requirements set forth in paragraph

(c)(1) of this section, three such

respirators will be tested against each

aerosol in accordance with the

provisions of paragraphs (d) and (e) of

this section.

(d) Lacquer mist test. (1) Temperature

in the test chamber will be

approximately 25° C.

(2) Continuous airflow through the

respirator will be 32 liters per minute

for air-purifying respirators, and not less

than 115 liters per minute to tight fitting

facepieces and 170 liters per minute to
30394 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

loose-fitting hoods and helmets of

powered air-purifying respirators.

(3) Airflow through the chamber will

be 20–25 air changes per minute.

(4) The atomizer employed will be a

No. 64–5 nozzle with setup 3, or

equivalent, operating at 69 kN/m.2 (10

pounds per square inch gage).

(5) The test aerosol will be prepared

by atomizing a mixture of one volume

of clear cellulose nitrate lacquer and one

volume of lacquer thinner. The lacquer

described in Federal Specification TT–

L–31, October 7, 1953, is an example of

an acceptable lacquer. Copies of TT–L–

31 may be inspected or obtained from

the NIOSH, Certification and Quality

Assurance Branch, 1095 Willowdale

Road, Morgantown, WV 26505–2888.

(6) The concentration of cellulose

nitrate in the test aerosol will be 95–125

milligrams per cubic meter.

(7) The test aerosol will be drawn to

each respirator for a total of 156 minutes

for air-purifying respirators and 240

minutes for powered air-purifying

respirators.

(8) The total amount of unretained

mist in the samples taken during testing,

weighed as cellulose nitrate, shall not

exceed 5 milligrams for an air-purifying

respirator, 28 milligrams for a powered

air-purifying respirator with tight-fitting

facepiece, and 41 milligrams for a

powered air-purifying respirator with

loose-fitting hood or helmet.

(e) Enamel mist test. (1) Temperature

in the test chamber will be

approximately 25° C.

(2) Continuous airflow through the

respirator will be 32 liters per minute

for air-purifying respirators, and not less

than 115 liters per minute to tight-fitting

facepieces and 170 liters per minute to

loose-fitting hoods and helmets of

powered air-purifying respirators.

(3) Airflow through the chamber will

be 20–25 air changes per minute.

(4) The atomizer employed will be a

No. 64 nozzle with setup 1A, or

equivalent, operating at 69 kN/m.2 (10

pounds per square inch gage).

(5) The test aerosol will be prepared

by atomizing a mixture of 1 volume of

white enamel and 1 volume of

turpentine. The enamel described in

Federal Specification TT-E–489b, May

12, 1953, with amendment-1 of 9

November 1955 is an example of an

acceptable enamel. Copies of TT-E–489b

may be inspected or obtained from the

NIOSH, Certification and Quality

Assurance Branch, 1095 Willowdale

Road, Morgantown, WV 26505–2888.

(6) The concentration of pigment in

the test aerosol, weighed as ash, will be

95–125 milligrams per cubic meter.

(7) The test aerosol will be drawn to

each respirator for a total of 156 minutes

for air-purifying respirators and 240

minutes for power air-purifying

respirators.

(8) The total amount of unretained

mist in the samples taken during testing,

weighed as ash, shall not exceed 1.5

milligrams for any air-purifying

respirator, 8.3 milligrams for a powered

air-purifying respirator with tight-fitting

facepiece, and 12.3 milligrams for a

powered air-purifying respirator with

loose-fitting hood or helmet.

(f) Bench tests; gas and vapor tests. (1)

Bench tests will be made in accordance

with § 84.207 and tested cartridges shall

meet the minimum requirements set

forth in Table 11 of subpart L of this

part. Cartridges will be equilibrated in

accordance with paragraph (f)(2) of this

section.

(2)(i) Two powered air-purifying

cartridges or pairs of cartridges will be

equilibrated at room temperature by

passing 25 percent relative humidity air

through them at the following flow rates

(expressed in liters per minute (l.p.m.))

for 6 hours:

Type of cartridge

Airflow

rate,

l.p.m.

Powered air purifying with tight-fitting facepiece ............................ 115

Powered air purifying with loosefitting hood or helmet ................ 170

(ii) Two powered air-purifying

cartridges or pairs of cartridges will be

equilibrated by passing 85 percent

relative humidity air through them at

the flow rates stated in paragraph

(f)(2)(i) of this section.

(iii) All cartridges will be resealed,

kept in an upright position, at room

temperatures, and tested within 18

hours.

§ 84.1158 Dust, fume, and mist tests;

respirators with filters; minimum

requirements; general.

(a) Three respirators with cartridges

containing, or having attached to them,

filters for protection against dusts,

fumes, and mists, except the mists of

paints, lacquers, and enamels, will be

tested in accordance with the provisions

of § 84.1157(f).

(b) In addition to the test

requirements set forth in paragraph (a)

of this section, three such respirators

will be tested, as appropriate, in

accordance with the provisions of

§§ 84.1141 through 84.1152; however,

the maximum allowable resistance of

complete dust, fume, and mist, and gas,

vapor, or gas and vapor chemical

cartridge respirators shall not exceed the

maximum allowable limits set forth in

§ 84.1157(a)(2).

Tables to Subpart KK of Part 84

TABLE 12.—FACEPIECE TEST REQUIREMENTS

[42 CFR Part 84, Subpart KK]

Respirator types

Pressure

tightness

test 1

Isoamyl acetate test

84.1141 84.1142

Dusts: Air Contamination Level not less than 0.05 mg/M3 or 2 mppcf ................................................... X

Fumes: Air Contamination Level not less than 0.05 mg/M3 .................................................................... X X

Mists: Air Contamination Level not less than 0.05 mg/M3 or 2 mppcf .................................................... X

Dusts, Fumes, and Mists: Air Contamination Level less than 0.05 mg/M3 or 2 mppcf, and radionuclides ................................................................................................................................................. X X

Radon daughters ...................................................................................................................................... X X

Asbestos-containing dusts and mists ...................................................................................................... X

1Test is required only where applicable.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30395

TABLE 13.—AIR-PURIFYING AND POWERED AIR-PURIFYING RESPIRATOR FILTER TESTS REQUIRED FOR APPROVAL

[42 CFR Part 84, Subpart KK]

Respirator types

Silica dust tests Lead fume

test 84.1146

Silica mist

test 84.1147

DOP test

84.1151 84.1144 84.1145 84.1152

Dusts: Air Contamination Level not less than 0.05 mg/

M3 or 2 mppcf ............................................................... X

Fumes: Air Contamination Level not less than 0.05 mg/

M3 .................................................................................. X

Mists: Air Contamination Level not less than 0.05 mg/M3

or 2 mppcf ..................................................................... X

Dusts, Fumes, and Mists: Air Contamination Level less

than 0.05 mg/M3 or 2 mppcf, and radionuclides .......... X X

Radon daughters .............................................................. 1X 2X

Asbestos-containing dusts and mists ............................... 2X 3X

Single use dust and mist respirators ................................ 3X 3X

1For resistance only.

2For penetration only.

3Test required only where applicable.

TABLE 14.—CARBON TETRACHLORIDE BENCH TESTS AND REQUIREMENTS FOR CANISTERS AND CARTRIDGES

[42 CFR part 84, Subpart KK]

Type of pesticide respirator

Test concentration

p.p.m. CCl4

Flow rate

l.p.m.

Number of

tests

Minimum

life minutes1

Chest-mounted or back-mounted gas mask (as received) .............................................. 20,000 64 3 12

Chest-mounted or back-mounted gas mask (equilibrated) .............................................. 20,000 32 4 12

Chin-style gas mask (as received) ................................................................................... 5,000 64 3 12

Chin-style gas mask (equilibrated) ................................................................................... 5,000 32 4 12

Chemical Cartridge respirator (as received) .................................................................... 1,000 64 3 50

Chemical cartridge respirator (equilibrated) ..................................................................... 1,000 32 4 50

Powered air-purifying respirator (tight-fitting facepiece, as received) ............................. 1,000 2 115 3 50

Powered air-purifying respirator (tight-fitting facepiece, equilibrated) ............................. 1,000 2 115 4 25

Powered air-purifying respirator (loose-fitting hood or helmet, as received) ................... 1,000 3 170 3 50

Powered air-purifying respirator (loose-fitting hood or helmet, equilibrated) ................... 1,000 3 170 4 25

1 Minimum life will be determined at 5 p.p.m. leakage.

2The flow rate shall be the effective flow rate of the device, but shall be not less than 115 l.p.m.

3The flow rate shall be the effective flow rate of the device, but shall be not less than 170 l.p.m.

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

APPENDIX A TO PREAMBLE—COMPARISON OF FINAL RULE TO PROPOSED RULE

Proposed

section

Final

section Change from proposal to final

84.1 84.1 No change from proposal.

84.2 84.2 No change from proposal.

84.3 Incorporation by reference section is not included in the final rule because of format requirements of the Federal

Register.

84.4 84.3 No change from proposal.

84.10 84.10 No change from proposal.

84.11 84.11 No change from proposal.

84.12 84.12 No change from proposal.

84.20 84.20 No change from proposal.

84.21 84.21 No change from proposal.

84.22 84.22 No change from proposal.

84.30 84.30 No change from proposal.

84.31 84.31 No change from proposal.

84.32 84.32 No change from proposal.

84.33 84.33 No change from proposal.

84.34 84.34 No change from proposal.

84.35 84.35 No change from proposal.

84.36 84.36 No change from proposal.

84.40 84.40 No change from proposal.

84.41 84.41 Changed from proposal to final rule for new incorporation by reference wording.

84.42 84.42 No change from proposal.

84.43 84.43 No change from proposal.

84.50 84.50 No change from proposal.

84.51 84.51 No change from proposal.

84.52 84.52 No change from proposal.
30396 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

APPENDIX A TO PREAMBLE—COMPARISON OF FINAL RULE TO PROPOSED RULE—Continued

Proposed

section

Final

section Change from proposal to final

84.53 84.53 No change from proposal.

84.60 84.60 No change from proposal.

84.61 84.61 No change from proposal.

84.62 84.62 No change from proposal.

84.63 84.63 No change from proposal.

84.64 84.64 No change from proposal.

84.65 84.65 No change from proposal.

84.66 84.66 No change from proposal.

84.70 84.70 No change from proposal.

84.71 84.71 No change from proposal.

84.72 84.72 No change from proposal.

84.73 84.73 No change from proposal.

84.74 84.74 No change from proposal.

84.75 84.75 No change from proposal.

84.76 84.76 Changed from proposal to final rule for new incorporation by reference wording.

84.77 84.77 No change from proposal.

84.78 84.78 No change from proposal.

84.79 84.79 Changed from proposal to final rule for new incorporation by reference wording.

84.80 84.80 No change from proposal.

84.81 84.81 Changed from proposal to final rule for new incorporation by reference wording.

84.82 84.82 No change from proposal.

84.83 84.83 No change from proposal.

84.84 84.84 No change from proposal.

84.85 84.85 No change from proposal.

84.86 84.86 No change from proposal.

84.87 84.87 No change from proposal.

84.88 84.88 Changed from proposal to final rule for new incorporation by reference wording.

84.89 84.89 No change from proposal.

84.90 84.90 No change from proposal.

84.91 84.91 No change from proposal.

84.92 84.92 No change from proposal.

84.93 84.93 No change from proposal.

84.94 84.94 No change from proposal.

84.95 84.95 No change from proposal.

84.96 84.96 No change from proposal.

84.97 84.97 Changed from proposal to final rule for new incorporation by reference wording.

84.98 84.98 No change from proposal.

84.99 84.99 No change from proposal.

84.100 84.100 No change from proposal.

84.101 84.101 No change from proposal.

84.102 84.102 No change from proposal.

84.103 84.103 No change from proposal.

84.104 84.104 No change from proposal.

84.110 84.110 No change from proposal.

84.111 84.111 No change from proposal.

84.112 84.112 No change from proposal.

84.113 84.113 Changed from proposal to final rule for new incorporation by reference wording.

84.114 84.114 No change from proposal.

84.115 84.115 No change from proposal.

84.116 84.116 No change from proposal.

84.117 84.117 No change from proposal.

84.118 84.118 No change from proposal.

84.119 84.119 Changed from proposal to final rule for new incorporation by reference wording.

84.120 84.120 No change from proposal.

84.121 84.121 No change from proposal.

84.122 84.122 No change from proposal.

84.123 84.123 No change from proposal.

84.124 84.124 No change from proposal.

84.125 84.125 No change from proposal.

84.126 84.126 No change from proposal.

84.130 84.130 No change from proposal.

84.131 84.131 No change from proposal.

84.132 84.132 No change from proposal.

84.133 84.133 No change from proposal.

84.134 84.134 No change from proposal.

84.135 84.135 No change from proposal.

84.136 84.136 Changed from proposal to final rule for new incorporation by reference wording.

84.137 84.137 No change from proposal.

84.138 84.138 No change from proposal.

84.139 84.139 No change from proposal.

84.140 84.140 No change from proposal.
Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations 30397

APPENDIX A TO PREAMBLE—COMPARISON OF FINAL RULE TO PROPOSED RULE—Continued

Proposed

section

Final

section Change from proposal to final

84.141 84.141 Changed from proposal to final rule for new incorporation by reference wording.

84.142 84.142 No change from proposal.

84.143 84.143 No change from proposal.

84.144 84.144 No change from proposal.

84.145 84.145 No change from proposal.

84.146 84.146 No change from proposal.

84.147 84.147 No change from proposal.

84.148 84.148 No change from proposal.

84.149 84.159 No change from proposal.

84.150 84.150 No change from proposal.

84.151 84.151 No change from proposal.

84.152 84.152 No change from proposal.

84.153 84.153 No change from proposal.

84.154 84.154 No change from proposal.

84.155 84.155 No change from proposal.

84.156 84.156 No change from proposal.

84.157 84.157 No change from proposal.

84.158 84.158 No change from proposal.

84.159 84.159 No change from proposal.

84.160 84.160 No change from proposal.

84.161 84.161 No change from proposal.

84.162 84.162 No change from proposal.

84.163 84.163 No change from proposal.

84.170 84.170 1. Changed to limit requirements to non-powered air-purifying respirators. Added description of non-powered air-purifying respirator.

2. Changed classification from ‘‘solid’’ and ‘‘liquid and solid’’ to ‘‘N-series, R-series, and P-series.’’

3. Changed efficiency level designations from A (99.97%), B(99%), and C (95%) to N100, R100, P100 (99.97%),

N99, R99, P99(99%), N95, R95, and P95(95%).

84.171 84.171 Changed to limit requirements to non-powered air-purifying respirators.

84.172 84.172 No change from proposal.

84.173 84.173 No change from proposal.

84.174 84.174 No change from proposal.

84.175 84.175 No change from proposal.

84.176 84.176 No change from proposal.

84.177 84.177 No change from proposal.

84.178 84.178 No change from proposal.

84.179 Air velocity and noise levels for hoods and helmets is not included in final rule because these are applicable to powered air-purifying respirators only.

84.180 84.179 1. Changed to limit requirements to non-powered air-purifying respirators.

2. Changed classification from ‘‘solid’’ and ‘‘liquid and solid’’ to ‘‘N-series, R-series, and P-series.’’

3. Changed efficiency level designations from A (99.97%), B(99%), and C (95%) to N100, R100, P100 (99.97%),

N99, R99, P99(99%), N95, R95, and P95(95%).

4. Changed labelling from S and L&S (e.g., Type A/L&S) to series and efficiency level (e.g., P100 particulate filter

(99.97% filter efficiency level)).

84.181 Isoamyl acetate tightness test for particulate respirators with filters not intended to be replaced is not included in the

final rule to avoid confusion and complications in the certification process.

84.182 Isoamyl acetate tightness test for respirators with replaceable filters is not included in the final rule to avoid confusion

and complications in the certification process.

84.183 84.180 1. Changed to increase initial inhalation resistance from 30 mm water-column height to 35 mm.

2. Changed to increase initial exhalation resistance from 20 mm water-column height to 25 mm.

84.184 84.181 1. Changed to limit requirements to non-powered air-purifying respirators.

2. Changed test terminology from filter penetration to filter efficiency.

3. Changed to reduce the number of tested units from 30 to 20.

4. Changed the test acceptance criterion from a statistical treatment of results to a pass/fail criterion.

5. Changed the tolerances for measurements to address testing consistency concerns.

6. Changed aerosol loading of tested filters to add the P-series test until there is no further decrease in efficiency.

7. Changed the description of dioctyl phthalate (DOP) aerosol to add a purity requirement.

8. Changed to require only N-series filters (formerly solid only) to be preconditioned before testing. The proposal required precondition of all filters before testing.

84.185 Powered particulate respirator flow requirements are not included in the final rule.

84.186 84.182 No change from proposal.

84.190 84.190 No change from proposal.

84.191 84.191 No change from proposal.

84.192 84.192 No change from proposal.

84.193 84.193 Changed from proposal to final rule for new incorporation by reference wording.

84.194 84.194 No change from proposal.

84.195 84.195 No change from proposal.

84.196 84.196 No change from proposal.

84.197 84.197 No change from proposal.

84.198 84.198 No change from proposal.

84.199 84.199 No change from proposal.
30398 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Rules and Regulations

APPENDIX A TO PREAMBLE—COMPARISON OF FINAL RULE TO PROPOSED RULE—Continued

Proposed

section

Final

section Change from proposal to final

84.200 84.200 No change from proposal.

84.201 84.201 No change from proposal.

84.202 84.202 No change from proposal.

84.203 84.203 No change from proposal.

84.204 84.204 No change from proposal.

84.205 84.205 No change from proposal.

84.206 84.206 No change from proposal.

84.207 84.207 No change from proposal.

84.250 84.250 No change from proposal.

84.251 84.251 No change from proposal.

84.252 84.252 No change from proposal.

84.253 84.253 No change from proposal.

84.254 84.254 No change from proposal.

84.255 84.255 No change from proposal.

84.256 84.256 No change from proposal.

84.257 84.257 No change from proposal.

84.258 84.258 No change from proposal.

Subpart KK (Dust, Fume, and Mist;

Pesticide; Paint Spray; Powered Air-Purifying

High Efficiency Respirators and Combination

Gas Masks) has been added to the final rule

to allow needed applications for extensions

of approvals for dust/fume/mist respirators

previously approved under 30 CFR Part 11.

This subpart also includes the requirements

for powered air-purifying respirators.

84.1100 Scope and effective dates.

84.1101 Definitions.

84.1102 Examination, inspection and

testing of complete respirator assemblies;

fees.

84.1103 Approval labels and markings;

approval of contents; use.

84.1130 Respirators; description.

84.1131 Respirators; required components.

84.1132 Breathing tubes; minimum

requirements.

84.1133 Harnesses; installation and

construction; minimum requirements.

84.1134 Respirator containers; minimum

requirements.

84.1135 Half-mask facepieces, full

facepieces, hoods, helmets, and

mouthpieces; fit; minimum requirements.

84.1136 Facepieces, hoods, and helmets;

eyepieces; minimum requirements.

84.1137 Inhalation and exhalation valves;

minimum requirements.

84.1138 Head harnesses; minimum

requirements.

84.1139 Air velocity and noise levels;

hoods and helmets; minimum

requirements.

84.1140 Dust, fume, and mist respirators;

performance requirements; general.

84.1141 Isoamyl acetate tightness test; dust,

fume, and mist respirators designed for

respiratory protection against fumes of

various metals having an air contamination

level not less than 0.05 milligram per cubic

meter; minimum requirements.

84.1142 Isoamyl acetate tightness test;

respirators designed for respiratory

protection against dusts, fumes, and mists

having an air contamination level less than

0.05 milligram per cubic meter, or against

radionuclides; minimum requirements.

84.1143 Dust, fume, and mist air-purifying

filter tests; performance requirements;

general.

84.1144 Silica dust test for dust, fume, and

mist respirators; single-use or reusable

filters; minimum requirements.

84.1145 Silica dust test; non-powered

single-use dust respirators; minimum

requirements.

84.1146 Lead fume test for dust, fume, and

mist respirators; minimum requirements.

84.1147 Silica mist test for dust, fume, and

mist respirators; minimum requirements.

84.1148 Tests for respirators designed for

respiratory protection against more than

one type of dispersoid; minimum

requirements.

84.1149 Airflow resistance tests; all dust,

fume, and mist respirators; minimum

requirements.

84.1150 Exhalation valve leakage test;

minimum requirements.

84.1151 DOP filter test; respirators designed

as respiratory protection against dusts,

fumes, and mists having an air

contamination level less than 0.05

milligram per cubic meter and against

radionuclides; minimum requirements.

84.1152 Silica dust loading test; respirators

designed as protection against dusts,

fumes, and mists having an air

contamination level less than 0.05

milligram per cubic meter and against

radionuclides; minimum requirements.

84.1153 Dust, fume, mist, and smoke tests;

canister bench tests; gas mask canisters

containing filters; minimum requirements.

84.1154 Canister and cartridge

requirements.

84.1155 Filters used with canisters and

cartridges; location; placement.

84.1156 Pesticide respirators; performance

requirements; general.

84.1157 Chemical cartridge respirators with

particulate filters; performance

requirements; general.

84.1158 Dust, fume, and mist tests;

respirators with filters; minimum

requirements; general.

[FR Doc. 95–13287 Filed 6–2–95; 12:10 pm]

BILLING CODE 4160–19–P

DEPARTMENT OF LABOR

Mine Safety and Health Administration

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

75

RIN 1219–AA85

Respiratory Protective Devices

AGENCY: Mine Safety and Health

Administration, Labor.

ACTION: Final rule.

SUMMARY: This final rule, in conjunction

with the National Institute for

Occupational Safety and Health

(NIOSH) final rule published

concurrently in this Federal Register,

transfers to NIOSH existing Mine Safety

and Health Administration (MSHA)

regulations pertaining to the testing,

performance, and joint MSHA-NIOSH

approval of respirators under the Mine

Act. MSHA retains existing provisions

related to the selection, use, and

maintenance of respirators for coal and

metal and nonmetal mines. Under the

NIOSH rule, MSHA retains joint

approval responsibility for certain

mining-related respiratory protective

devices. MSHA’s transfer of the

respirator approval program to NIOSH

will more accurately reflect the

respective roles of the two agencies in

the approval of respirators. A

memorandum of understanding (MOU)

between MSHA and NIOSH delineates

the roles of both agencies in the

respirator approval program. This MOU

is published elsewhere in this separate

part of the Federal Register. MSHA’s

final rule will not affect the compliance

responsibilities of mine operators.

EFFECTIVE DATE: This final rule is

effective on July 10, 1995. The

incorporation by reference of certain