Respiratory Protective Devices

SUMMARY: This final rule addresses NIOSH and the Department of Labor/

Mine Safety and Health Administration (MSHA) certification requirements

for respiratory protective devices. Specifically, the rule replaces

MSHA regulations with new public health regulations, while also

upgrading testing requirements for particulate filters.

This action is the first of a series of modules that will

incrementally upgrade current respirator approval requirements. This

modular approach will allow improvements to be implemented on a safety

and health priority basis as well as facilitate adaptation to new

requirements by the manufacturers and users of respirators. It will

also expedite the incorporation of technological advancements and will

allow for the expeditious response to emerging hazards.

Except for the particulate-filter requirements, most requirements

of the existing regulations are incorporated into the new regulations

without change. The revised testing requirements for particulate

filters significantly improve the effectiveness of evaluating air-

purifying filters to remove toxic particulates from the ambient air.

These requirements are consistent with two decades of advances in

respiratory protection technology.

The certification of air-purifying respirators under the final rule

will also enable respirator users to select from a broader range of

certified respirators that meet the performance criteria recommended by

CDC for respiratory devices used in health-care settings for protection

against Mycobacterium tuberculosis (Mtb), the infectious agent that

causes tuberculosis (TB).

Elsewhere in this separate part of the Federal Register, MSHA is

publishing a final rule to remove existing regulations which are made

obsolete by this final rule.

EFFECTIVE DATES: This final rule is effective on July 10, 1995. The

incorporation by reference of certain publications used in the

regulations is approved by the Director of the Federal Register as of

July 10, 1995.

FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, NIOSH, 1095

Willowdale Road, Morgantown, West Virginia 26505-2888. The telephone

number is (304) 285-5907.

SUPPLEMENTARY INFORMATION:

I. Availability of Copies and Access to Final Rule

Additional copies of this final rule can be obtained by calling the

NIOSH toll-free information number (1-800-35-NIOSH, option 5, 9:00 AM-

4:00 PM ET). Arrangements have also been made for this final rule to be

listed on the electronic bulletin boards of the Government Printing

Office and of the Department of Labor; the telephone numbers are (202)

512-1387 and (202) 219-4784, respectively. This final rule may also be

obtained from the NIOSH Home Page on the World-Wide Web. The location

for the NIOSH Home Page is http://www.cdc.gov/niosh/homepage.html.

II. Paperwork Reduction Act

This final rule contains information collections that have been

approved by the Office of Management and Budget under the Paperwork

Reduction Act of 1980 and assigned control Number 0920-0109. The title,

description, and respondent description of the information collection

are shown below with an estimate of the annual reporting and

recordkeeping burden. Included in the estimate is the time for

reviewing instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information.

Title: Respiratory Protective Devices.

Description: This rule prescribes requirements and procedures which

must be met in filing applications for approval by NIOSH of respirators

and modifications of respirators.

Description of Respondents: Businesses and other for-profits.

Estimated Annual Reporting and Recordkeeping Burden:

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

Annual

Section number of Annual Average burden per Annual burden

respondents frequency response hours

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

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

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

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

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

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

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

The above citations are currently cleared under 30 CFR Part 11 as OMB

control Number 0920-0109.

A Paperwork Reduction package is being submitted to OMB, requesting

approval of the requirement for labeling to be effected by Sec. 84.33.

A document will be published in the Federal Register when such approval

has been obtained.

III. Background

NIOSH published a proposed rule (59 FR 26850) to establish a new 42

CFR part 84, on May 24, 1994. On May 26, 1994, NIOSH published a notice

in the Federal Register (59 FR 27257) for an extension of the public

comment period and a rescheduling of a public meeting. A public meeting

was held to obtain comments on the proposal in Washington, D.C. on June

23-24, 1994.

The proposal and public meeting received response from the full

complement of affected parties in the public. Commenters included

safety professionals, respirator manufacturers, representatives of

industrial and health-care facilities, and workers' associations. Three

hundred and three commenters responded to the proposed rule. One

hundred twenty six commenters represented health-care workers. Ninety

six commenters represented health-care facilities. Fifteen commenters

represented associations of health-care professionals. Fifteen

commenters represented associations of health-care facilities.

Seventeen commenters represented respirator manufacturers. Eight

commenters represented trade or manufacturers' associations. Eight

individuals commented as private citizens. Six commenters represented

regulatory agencies (federal, state, [[Page 30337]] county). Five

commenters represented respiratory protection experts. Three commenters

represented workers' organizations. Two commenters represented test

instrument manufacturers. One commenter represented industrial hygiene

professionals. One commenter represented a Federal Advisory Committee.

These figures include the 18 presenters at the Public Meeting held in

Washington, D.C. on June 23 and 24, 1994.

IV. Summary of Major Changes in Response to Comments

The requirements of the final rule differ from those proposed (59

FR 26850) in 8 major areas. These changes, discussed in sections V.

Administrative and Procedural Matters of Final Rule and VI. Discussion

of Final Rule, are summarized as follows:

1. Three categories (series) of particulate filters (N-, R-, and P-

series) are included rather than two (solid and liquid and solid);

2. Maximum allowable inhalation and exhalation airflow resistance

values have been slightly increased and labelling changes are included

to identify the certified efficiency level to users;

3. The new certification categories apply only to non-powered air-

purifying respirators. Powered air-purifying particulate respirators

(PAPRs) will be approved only with filters meeting the requirements for

30 CFR part 11 high-efficiency filters;

4. A new subpart KK has been added for the issuance of extensions

of existing 30 CFR part 11 approvals to address respirator non-

conformances when there is a demonstrated safety or health need during

the transition period and for the approval of PAPRs;

5. Fit testing during the certification process is not included for

particulate respirators;

6. The number of tested units has been reduced and the test data

will no longer be treated statistically;

7. The period for sale and shipment of 30 CFR part 11 certified

particulate respirators has been increased. The period for processing

part 11 applications has been eliminated, except for demonstrated need;

and

8. Testing parameters are stated more explicitly.

A summary listing of the section-by-section changes from the

proposal to this final rule is provided in Appendix A--Comparison of

Technical Requirements Final Rule to Proposed Rule. Each of these

changes is discussed in detail in the following preamble.

V. Administrative and Procedural Matters of Final Rule

A. Modular Approach

The proposed rule explained the intent to promulgate modifications

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

numerous benefits to utilizing a modular approach to promulgate changes

to the existing requirements. Among these are the following

considerations:

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

that those expected to contribute most to improving worker protection

are implemented first;

2. Incremental promulgation of improvements should facilitate

adaptation to new requirements by the respirator manufacturer and user

communities, minimizing the potential for any disruption in the supply

of certified respirators;

3. Public participation in the rulemaking process will be

facilitated by proposing important regulatory changes in individual

segments of separate rulemaking; and

4. Improvements made to limited segments of the rule can be

implemented in a much shorter time period than comprehensive revisions

to the entire rule. Therefore implementation of technological

advancements and response to emerging hazards will be expedited.

Comments overwhelmingly endorsed the concept of the modular

approach with only two comments specifically opposed to this approach.

More than 250 comments supported the proposal's approach and

approximately 40 specifically endorsed and offered recommendations for

changes in the modular scheduling. Some commenters expressed concerns

about this new rulemaking procedure. These predominantly questioned the

interaction of modules and implementation schedules. Module interaction

concerns included added costs, confusion, transition periods

(grandfathering) of interrelated modules, and redesign of respirators

due to effects of multiple modules. Concerns of scheduling included the

priority of modules, additional module topics, transition periods for

products to meet prior requirements, timetable for completion of

revisions, and availability of NIOSH resources to support work on

multiple modules simultaneously.

The modular approach represents a continuous improvement strategy

for rulemaking. With this process, NIOSH expects regulations and

products to be incrementally improved and updated to address worker

health concerns and prevent any disruption in the supply of

respirators. Each module will constitute a separate rulemaking

activity. The modular approach undertaken by NIOSH provides clear

advantages over the comprehensive approach to rulemaking. No specific

time period has been identified in which all certification standards

will be revised. The Institute recognizes that a predetermined revision

cycle could ensure the periodic re-examination of standards. However, a

requirement of this type would also diminish the capability of the

Institute, with its limited resources, to address priority respiratory

protection needs. The Institute has determined that a flexible approach

is required that will permit expeditious responses to emerging

respiratory protection priorities. These can change rapidly as

technological advancements, international harmonization, changed

working conditions, or the emergence of new hazards make current

standards obsolete. As discussed below the Institute will balance

industry's need for planning and adjustment time associated with future

modules by having ample public involvement in setting the priorities

for module selection and with judicious selection of transition

periods.

NIOSH is aware of the needs of the respirator community to be able

to plan future production and purchasing needs. This is true for

consumers as well as manufacturers of respirators. NIOSH announced at

the informal public meeting its intention to hold ample public meetings

in advance of any proposed future modules so that these concerns could

be addressed. The concerns expressed in the comments can be addressed

in these informal public meetings and with the use of appropriate

transition periods.

NIOSH intends to establish transition periods for implementing the

requirements of each module. These transition periods will be

determined by an assessment of the industry's ability to adopt the new

requirements, ongoing transition periods from prior modules, and the

public health implications of the changes.

Anticipated subjects and sequence of the NIOSH rulemaking were

outlined in the proposed rule. Numerous comments were received

providing suggestions for additional module subjects and their

priority. Suggested additional subjects included powered air-purifying

respirators, smoke masks, fit testing, supplied air respirators, gas

masks, and combination respirators. Suggestions on scheduling

priorities indicated a diversity in perceived needs. Based on the

public interest in the future module [[Page 30338]] subject areas and

timetable, NIOSH will conduct a public meeting to further develop the

schedule with input from all interested parties. The location and date

for this meeting will be announced in the Federal Register, Morbidity

and Mortality Weekly Report (MMWR), and other media.

The Institute coordinated the development and implementation of the

modular approach with OSHA and MSHA. The specific requirements of this

first module were reviewed and accepted by both agencies to ensure that

42 CFR part 84 properly links with OSHA and MSHA respirator use

regulations. Both agencies will participate in the development by NIOSH

of appropriate user guidelines. NIOSH and MSHA developed a Memorandum

of Understanding to delineate roles for the continuing joint approval

under 42 CFR part 84 of respirators used for mine emergencies and mine

rescue. The Institute will continue to collobrate with MSHA and OSHA as

future modules are developed.

B. User's Guide

The proposal stated the intent to develop a user's notice or guide

to explain the use of respirators certified for protection against

particulate exposures under the new 42 CFR part 84 that would replace

the existing filter respirators certified under 30 CFR part 11 subparts

K and M. Commenters indicated that this user's guide should be

developed in a public forum with public involvement. One commenter

stated that the user's guide should be issued prior to the finalization

of part 84. Another believed that its availability should coincide with

the publication of the final rule. Constraints on releasing specific

information as to the contents of the final rule prior to its

publication limits the availability of information needed for

development of a user's guide, thus making its development with public

input prior to or concurrent with this rule impossible. NIOSH agrees

with the commenters that public input into the user's guide will result

in a better product. An informational respirator user's guide for part

84 respirators will be developed with public involvement.

The user's guide will address both the use of part 11 and part 84

respirators during the transition period. Assigned Protection Factor

(APF) values are used in the respirator selection process to indicate

the expected protection level for the respirator wearer. NIOSH

recommends APFs for respirators certified under 30 CFR part 11 in its

Guide to Industrial Respiratory Protection and in the Respirator

Decision Logic. The future user's guide will recommend APFs appropriate

for use with the part 84 particulate respirators until APFs can be

addressed through future rulemaking. It will also provide information

and recommendations on a variety of other respirator use issues

associated with this current rulemaking.

During review of this rule, both OSHA and MSHA expressed strong

interest in the APF values for the new part 84 particulate filter

classifications. Both agencies agreed with NIOSH that APFs could not be

addressed properly in this first module. They therefore urged NIOSH to

develop a subsequent module defining APFs for all respirators. In the

interim, OSHA regulations under Title 29 and the MSHA regulations under

Title 30 will allow the use of the new part 84 particulate

classifications with the APFs to be established by NIOSH in the users'

guide. OSHA is in the process of updating its respirator use

regulations, and the current proposal specifies acceptance of APFs

developed and promulgated under part 84.

C. Use of Particulate Respirators for Protection Against TB

While the requirements in this final rule were not developed

specifically to certify respirators against biological agents, this

rule will address the important public health need to control the

transmission of Mycobacterium tuberculosis, the causative agent of TB,

in health-care and other facilities through the use of respiratory

protective devices.

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

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

multidrug-resistant TB, CDC published ``Guidelines for Preventing the

Transmission of Mycobacterium tuberculosis in Health-Care Facilities,

1994'', in the Federal Register (59 FR 54242) and MMWR (Volume 43, No.

RR-13) on October 28, 1994. These guidelines enumerate four performance

criteria that CDC has determined are necessary for respiratory

protective devices used in health-care settings for protection against

TB. The only currently certified air-purifying respirator class that

meets all the respiratory protection performance criteria in the CDC

Guidelines is a respirator with a high efficiency (HEPA) filter. Many

comments were received from the health-care community supporting the

positive impact of the proposed rule on compliance with the CDC

Guidelines.

All nine classes of air-purifying, particulate respirators to be

certified under the provisions of the new particulate filter tests

(filter efficiency) in part 84 meet or exceed the performance

recommendations contained in the CDC Guidelines. Several of these new

classes of air-purifying, particulate respirators are expected to be

less expensive than respirators with HEPA filters. Consequently,

implementation of the modifications included in this rule should

promote a substantial increase in respiratory protection provided to

health-care and other workers potentially exposed to the M.

tuberculosis droplet nuclei in health-care and other occupational

settings.

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

Since 1974, the Mine Enforcement and Safety Administration (MESA),

MSHA, and the Occupational Safety and Health Administration (OSHA) have

regulated the selection, use, and maintenance of respirators in the

workplace under their respective enforcement authorities. NIOSH is not

including the requirements of Secs. 11.2 and 11.2-1 with this

redesignation to 42 CFR part 84. Sections 11.2(a) and 11.2-1 refer to

respirator use and selection criteria that since have been superseded

by OSHA and MSHA respirator regulations.

Section 11.2(b) allows for the continued manufacture and sale of

gas masks approved under the former U.S. Bureau of Mines (BOM) Schedule

14F (dated April 23, 1955). This Schedule was replaced by the

requirements in Subpart I of 30 CFR part 11 in 1972. Gas masks approved

under Subpart I of 30 CFR part 11 (14G canisters) are widely available

and only a limited number of types of 14F canisters are marketed. MSHA

experience indicates that few of the 14F respirators are currently sold

or used. MSHA also indicated that removal of the provisions in

Sec. 11.2(b) would remove the authority to market these respirators as

approved devices.

NIOSH is not transferring the requirements of Sec. 11.2(b) to 42

CFR Part 84 since NIOSH does not have the capability to process

applications for these respirators. The approval records on these BOM-

approved respirators no longer exist and therefore NIOSH has no way of

monitoring the production of these respirators to assure that they

continue to meet the approved design. Thus, NIOSH will not authorize

the sale and shipment of the Schedule 14F respirators under this part

84.

In addition, the codification of the redesignated sections into a

non-hyphenated numbering system results in several general heading

sections that contained no substantive requirements [[Page 30339]] not

being included in this redesignation. These include Secs. 11.85,

11.102, 11.124, 11.140, and 11.162.

NIOSH is making a limited revision to the existing requirements of

30 CFR part 11 in this first module, requiring updated particulate

filter tests. This revision eliminates the need for unique tests for

particulate respirators used for different types of aerosols, such as

dust/mist, dust/fume/mist, paint spray, and pesticides. The new

certification tests use the most penetrating aerosol size,

0.3m, and either a non-degrading particulate, sodium chloride,

or a highly degrading oil, dioctylphthalate. Consequently, particulate

filters certified under these new procedures can be used without regard

to aerosol size, taking into consideration only the degrading or

nondegrading nature of particulates and the APF required by exposure

concentrations. To revise respirator nomenclature to be consistent with

this fundamental change in certification philosophy, the words dust,

fume and mist are replaced with particulate in the final rule.

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

addresses the requirements for pesticide respirators. The requirements

of subpart M are not included in this redesignation to 42 CFR part 84.

This rule eliminates this category and the tests specific to it,

leaving subpart M reserved. All references to subpart M and pesticides

as a classification for approval are eliminated. NIOSH will discontinue

issuance of certifications that classify these respirators as suitable

for use against a specific particulate.

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

specify that a test subject wearing the respirator be exposed to an

abrasive blasting environment in which the blasting agent is composed

of 99+ percent free silica (SiO2). This requirement is not

included in this redesignation to 42 CFR part 84. The purpose of this

requirement was to determine the adequacy of protection provided in

such environments. NIOSH administratively suspended such tests over 20

years ago because they placed test subjects at risk of exposure to

fractured crystalline silica. These tests are not included in this

final rule. Requirements for abrasive blasting and other atmosphere

supplying respirators as well as fit testing for all respirator types

will be addressed in a future module. In the interim, NIOSH will

continue the administrative policy of the past two decades of

conducting quantitative fit testing in lieu of the tests stipulated in

Secs. 11.124-21 through 11.124-24.

Two comments recommended the inclusion of administrative policies

to the rule. One commenter suggested that Secs. 11.124-21 through

11.124-24 (referring to air-line respirators) be restored or replaced

with the current administrative policy of quantitative fit testing.

Another commenter was concerned that the NIOSH policy of allowing a

mixed-gas Self Contained Breathing Apparatus for fire fighting was not

included in the proposed rule. NIOSH agrees with these commenters that

administrative policies related to specific changes in a module should

be incorporated. However, the topics of concern to these commenters

addressed administrative policies in subject areas that were not

proposed to be changed in this module, therefore, they have not been

incorporated.

NIOSH has not included the test procedures of Secs. 11.124-21

through 11.124-24 due to NIOSH's concern of health risks to test

subjects during pre-submission testing performed by a manufacturer

seeking approval of a respirator intended for use in an abrasive

blasting environment. Although no Type AE or BE respirators have ever

been certified, Type AE, BE, and CE respirators may be certified for

use in an abrasive blasting environment. These respirators will be

tested using Air-supplied Respirator Section Test Procedure Number 23

Abrasive-Blast, Type CE. Copies of this procedure are available from

the Certification and Quality Assurance Branch, 1095 Willowdale Road,

Morgantown, West Virginia, 26505-2888.

E. MSHA's Regulatory Role

The final 42 CFR part 84 regulation is consistent with the current

MSHA and NIOSH respirator approval program, placing responsibility for

certifying most respirators with NIOSH. MSHA and NIOSH will continue to

jointly review and approve respirators used for mine emergencies, mine

rescue, and the associated service-life plans, user's manuals, and

other documentation. Among the types of devices for which this role is

particularly important are self-contained self-rescue devices. The

final rule preserves MSHA's current role in the certification of such

respirators whose unique use in mining is an important part of

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

continue to test electrical and electronic components of respirators

for use in potentially explosive atmospheres in gassy underground mines

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

electrical components of such respirators.

In implementing the final regulation, NIOSH and MSHA have developed

a new Memorandum of Understanding (MOU) that reflects administrative

matters related to respirator approval, including immediate

notification to MSHA of field complaints and identified deficiencies

concerning approved respirators. Three commenters recommended that the

public be allowed to review and comment on the MSHA/NIOSH Memorandum of

Understanding. It was indicated by an agency representative that such

comments on the contents of the MOU would be welcomed. Two of these

commenters were concerned that the responsibilities and accountability,

specifically MSHA's involvement in the certification of mining-specific

respiratory protective devices, be maintained in the Memorandum of

Understanding. The third commenter was unsure if the Memorandum of

Understanding would have an effect on the notice of public rulemaking.

Comments submitted subsequent to the public meeting reiterated the

concerns stated at the meeting. These comments were considered in the

MOU's development and have subsequently been addressed. Copies of the

MOU will be available from NIOSH and MSHA.

The new Memorandum of Understanding between MSHA and NIOSH

delineates the interaction between the agencies in carrying out the

responsibilities and authorities provided for in the Mine Safety and

Health Act of 1977 (30 USC Sec. 801 et seq) and this final rule. It

defines the method of implementation of the regulation and has no

effect on its content. The agency has determined that this MOU is most

appropriately developed between the two agencies and thus, commenters

did not directly participate in the development of the MOU. As

indicated above, public comments on the MOU are welcome.

F. Transition Period

The proposal included provisions for phasing out part 11

particulate respirators. Specifically, no applications were to be

accepted after the effective date of part 84, with a maximum of 6

months for processing in-house applications. Sale and shipment

(distribution) of part 11 particulate respirators would have been

allowed for only 2 years from the effective date of part 84.

Several commenters indicated that these transition periods were

much shorter than the 5-year phase-out period proposed by NIOSH in

1987. Some comments on the proposed schedule stated that there must be

an appropriate [[Page 30340]] time to develop new products, receive

certification, and initiate production of the new respirators.

Commenters were also concerned the use of the term distribution implied

manufacturer control of the distributer system and the resale market.

Several commenters recommended 4 years for NIOSH-processing of part 11

applications, and for sale and shipment of part 11 respirators. NIOSH

is expanding the phase-out period from two to three years to address

these concerns.

With the effective date of part 84, MSHA and NIOSH will no longer

accept applications for new approvals or extensions of approval of

respirators under part 11 provisions. All applications received after

the effective date of part 84 will be considered as applications for a

new or extension of approval under part 84. Valid part 11 applications

that were received prior to the effective data of part 84 will be

processed for approval under part 11 provisions. A subpart KK

containing the part 11 requirements for particulate respirators has

been added to the final rule to provide continued authority for NIOSH

to issue extensions of approvals needed to address respirator recall

and retrofit matters that are associated with health and safety issues

for workers. Respirators listed as certified under the provisions of 30

CFR part 11, subparts K or M, may not be sold or shipped by the

approval holder as NIOSH/MSHA certified respirators effective July 10,

1998. Continued use of distributed particulate respirators is under the

jurisdiction of OSHA and MSHA and therefore is not affected by this

rule. Because certifications will not be revoked for part 11 devices

sold and shipped by the approval holder prior July 10, 1998, NIOSH

anticipates that OSHA and MSHA would permit continued use of those part

11 respirators.

This 3 year period was selected to ensure the timely replacement of

the part 11 respirators that exhibit low initial efficiency levels

while allowing an ample supply of respirators to remain available for

use. This timeframe will provide sufficient time for manufacturers to

have respirators approved and manufactured in quantities to meet

demand. Manufacturers' comments to the proposed rule support this

timeframe, as some manufacturers appear ready to provide part 84

respirators immediately. At least one commenter stated, without

reservation, preparedness to submit applications to meet the new

requirements. Several commenters requested that NIOSH accept

applications for part 84 respirators upon publication, rather than the

effective date of part 84. One manufacturer commented that NIOSH should

anticipate at least 10 applications from each manufacturer upon part 84

becoming effective. NIOSH also expects a significant number of

presently certified particulate respirators, in addition to new

designs, to meet the requirements of this rule. Therefore, a high

initial application rate for approval of part 84 particulate

respirators is expected.

Some commenters expressed concern that NIOSH would not be able to

expeditiously process the part 84 applications, thereby delaying

introduction of the new respirators to the marketplace. Delays in

processing the part 84 applications would prolong the time needed for

transition to these new respirators. Division of the NIOSH staff and

resources between processing part 84 applications and pending part 11

applications, along with routine extensions of existing part 11

particulate respirator certifications, may initially slow the

certification and availability of part 84 respirators. However, the

Institute has determined that it cannot reject without action part 11

applications that were validly prepared and submitted while the

provisions of part 11 remain in effect. NIOSH therefore will process

all valid part 11 applications that were received by NIOSH before the

effective date of part 84. The authority for the approval holder to

sell and ship particulate respirators under any part 11 certification

issued under these conditions will expire along with the other part 11

certifications on July 10, 1998.

The new technical requirements of part 84 only address air-

purifying respirators. Other classes of respirators, such as self-

contained breathing apparatus, gas masks, etc., are not affected by the

new filter penetration test requirements. Therefore, NIOSH intends to

continue issuing new and extension of approval numbers in the same

format designation (TC number) as issued under existing part 11 for

those respirator types whose technical requirements for approval under

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

number series will be initiated for the products whose technical

requirements have been upgraded under part 84. By checking the approval

number, respirator users will be able to quickly and easily distinguish

those products that have demonstrated the improved performance

requirements of the new part 84 from those that have demonstrated

compliance with only the existing part 11 standards that are

transferred to part 84. NIOSH further intends to issue public notices

of the new approval designations to be used for products demonstrating

performance to the improved standards.

VI. Discussion of Final Rule

A. Certification Fit Testing

The proposal contained two sections (Secs. 84.181 and 84.182) that

would have retained the existing Part 11 particulate respirator fit

test protocols using isoamyl acetate. These tests were proposed to

redesignate the existing Secs. 11.140-1 and 11.140-2 with the tests

unchanged to minimize the scope of the changes proposed in the first

module.

The currently required particulate respirator facepiece fit tests

of part 11 use isoamyl acetate, an organic vapor, as the test agent.

Under existing part 11, such tests are required for high efficiency

(HEPA) and dust, fume, and mist (DFM) respirators, but not dust/mist

(DM) respirators. Since particulate filters are not intended to filter

organic vapors, the tested respirators must often be modified by the

addition of an activated charcoal layer. This added charcoal layer

prevents penetration of the isoamyl acetate through the filter so that

the respirator-to-face fit can be evaluated. As a result, the

certification program tests surrogate respirators that may have fitting

characteristics that differ from the marketed (certified) respirators.

Numerous and varied comments were provided on these sections. A

number of commenters suggested that NIOSH eliminate fit testing as a

condition of certification. Two commenters recommended that the rule

should require manufacturers to submit test data showing good fit

characteristics in lieu of NIOSH conducting fit testing. Other

commenters requested that NIOSH test the respirator-to-face fit, or

otherwise assure that proper fitting characteristics were provided by

every certified respirator. Several other commenters requested that fit

testing be made a meaningful test. Several others suggested that a

quantitative protocol rather than a qualitative fit protocol should be

used. Two commenters stated support for the fit tests as proposed.

Several of the reasons given for eliminating fit testing were that

fitting respirators to individuals in the certification program does

not predict the fit of an individual wearer; fit testing of individual

workers at the worksite is required by OSHA and that is the appropriate

setting for fit testing; the isoamyl acetate test has not been

validated; and, the isoamyl acetate test [[Page 30341]] has to be

performed on modified respirators.

The comments requesting that fit testing be made a meaningful test

were based on reasoning similar to those suggesting elimination of the

test. In lieu of elimination, they suggested that some inadequacies

could be resolved with modification of the test protocol to use a

particulate aerosol, such as Bitrex, as the test agent. Changing the

test protocol to test with a particulate would at least permit the

tested respirator filters to be as certified, thereby eliminating

specially-made surrogates.

Commenters endorsing NIOSH continuation of fit testing believed

that the present certification process provides an assurance that the

respirator will properly fit a given worker when use of the respirator

is needed in the workplace.

The problems associated with testing the facepiece-fit in a

certification program have been recognized for years. Efforts have been

made to seek more meaningful test results; nevertheless, the validity

of the test results remain questionable.

Successful fit testing in the certification process provides no

assurance that the respirator will properly fit a given worker when

used in the workplace. The only means presently available to assess the

fit achieved on the worker is a respirator-to-face fit test conducted

on that individual with the chosen respirator. Even this test

procedure, conducted on the individual, cannot assure that the

respirator will maintain a proper fit when use of the respirator is

needed in the workplace. This concern is compounded when the fit is

determined with a surrogate respirator.

During review of this rule, both OSHA and MSHA favored inclusion of

respirator fit testing and fit checking procedures as part of NIOSH

respirator certifications under the new part 84 particulate filter

classifications. Both agencies accepted the determination by NIOSH that

these issues cannot be properly addressed in this first module. Both

agencies therefore urged NIOSH to develop a face fit module to include

respirator fit testing and fit checking procedures for all respirators.

The purpose of face fit testing in the certification program has

been to assure that respirators have generally good face fitting

characteristics. However, at this time NIOSH does not have studies that

define the effectiveness of either the isoamyl acetate or American

National Standards Institute (ANSI)/OSHA accepted fit tests in

predicting actual workplace protection provided to workers. NIOSH is

presently conducting research for this purpose. In the interim, lacking

validation and correlation of testing protocols, workers' health

concerns are best served through the application of fit-testing and

fit-checking procedures on individual workers in a quality respirator

program. Therefore, the isoamyl acetate fit tests proposed in

Secs. 84.181 and 84.182 are not included in this final rule. NIOSH will

address issues associated with face-fit efficacy in a separate module

upon completion of the necessary research.

B. Powered Air-purifying Particulate Respirators

The proposed regulation included filter efficiency requirements for

powered air-purifying respirators (PAPRs). The solid and liquid and

solid categories were to be tested with sodium chloride (NaCl) and

dioctyl phthalate (DOP), respectively. The classes to be certified were

the 99.97 and 99% efficiency levels. The remaining design and test

parameters for PAPRs were retained from part 11 without change.

Commenters questioned why the efficiency levels proposed for PAPRs

were not the same as non-powered respirators. The proposal specified

three efficiency levels for non-powered (95, 99, 99.97) and only two

levels for PAPRs (99 and 99.97). Commenters indicated many present

filter cartridges are interchangeable between the non-powered and PAPR

units, recommending corresponding filter efficiencies between the non-

powered and PAPR units to retain this broader market for a filter

design.

Numerous commenters stated a concern that the proposed requirements

of subpart K did not adequately address PAPRs. These commenters

indicated that the respiratory protection provided by PAPRs is

dependent on the respirator components working together as a system.

The proposed rule, focusing on filter efficiency, did not address the

system requirements for these respirators. These commenters reasoned

that the performance of these complicated respirator systems deserves

special consideration because of unique problems addressing airflow,

filter efficiency, and fit. These commenters suggested that the

requirements for powered units be removed from subpart K, to be

addressed in a separate module.

Other commenters addressing PAPR requirements stated concerns over

sodium chloride (NaCl) filter test instrumentation capabilities. With

the present state-of-the-art capabilities, the proposed PAPR loading

requirements are difficult to achieve. This leads to a number of

testing difficulties including instrumentation availability, time

consuming tests, reproducibility of results, and system costs. NIOSH

agrees with these concerns and will address them in the forthcoming

module.

Commenters to the proposal also acknowledged that the resultant

part 84 filters would be a significant improvement over those currently

certified and marketed under part 11. Two commenters recognized the

concern over the performance of part 11 powered dust, fume, mist

respirators. They indicated that this concern could be addressed by

incorporating only part 11 high-efficiency filter requirements for

PAPRs approved under part 84. NIOSH agrees and has revised the rule to

permit the continued use of part 11 high efficiency filters for PAPRs

approved under part 84.

NIOSH also agrees with commenters that the proposed filter

efficiency requirements alone do not adequately address the operational

parameters of PAPRs that should be revised. The sections of subpart K

have therefore been modified to be applicable only to non-powered air-

purifying particulate respirators. The requirements for the powered

units will be addressed in a forthcoming module. In the interim,

powered air-purifying particulate respirators equipped with HEPA

filters will be approved under the provisions of subpart KK.

C. Filter Classification

The proposal provided for six classes of filters in a filter

classification system with three filter efficiency levels and two

categories of filter degradation resistance. The three efficiency

levels (99.97, 99, and 95%) were determined by testing with the most

penetrating aerosol size until a maximum loading of 200 mg was reached.

The two degradation resistance categories were established by the

choice of either NaCl or DOP as the test challenge aerosol. Sodium

Chloride is only mildly degrading to filter media while DOP is a liquid

oil that is highly degrading. Accordingly, filters tested with the NaCl

aerosol were recognized as not highly resistant to degradation and only

appropriate for use with solid aerosols in the workplace. Filters

tested with the liquid DOP oil were recognized as highly resistant to

degradation and considered appropriate for both liquid and solid

workplace aerosols.

The categories and classes of filters that would have been

certified under the proposal are summarized below:

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

Test

Category Class Efficiency agent

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

Solid and liquid.......................... A 99.97 DOP

[[Page 30342]]

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

Solid and liquid.......................... B 99 DOP

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

Solid and liquid.......................... C 95 DOP

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

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

The behavior of filters to challenge by each of the two test

aerosols depends on the filter type. Mechanical filters and

electrostatic filters are the two fundamental types of particulate

filters on the market. Mechanical filters' efficiencies are determined

by mechanical features such as the diameter, orientation, and

arrangement of the fibers that comprise the filter. Electrostatic

filters have a static electric charge on the filter fibers to enhance

the attraction and retention of the aerosolized particles. The enhanced

efficiency due to the electrical charge means that an electrostatic

filter generally offers lower breathing resistance than a mechanical

filter with the same initial efficiency. This occurs because fewer

fibers are needed in the electrostatic filter to achieve the same level

of efficiency as a mechanical filter. However, the efficiency of

electrostatic filters can be significantly reduced by exposure to

certain aerosols while mechanical filters are generally more resistant

to degradation.

Comments concerning resistance of filters to degradation were

generally of two conflicting schools of thought. One school favored

replacing the two proposed tests with a single, more severe test. The

other favored retaining the two proposed tests at the same or reduced

level of severity.

Commenters opposing the proposed classification system stated it

was not a severe enough test of resistance to filter degradation

because it did not represent a worst-case test. They recommended

testing all filters with a DOP aerosol with the test continued until

there was no further decrease in filter efficiency. Those supporting

this position argued that the proposed filter classification system

could result in overexposure of workers as workplace aerosols degrade

some filters to a level below the certified efficiency level. It was

indicated that various workplace contaminants can cause the beneficial

filtering effects of the charge on electrostatic filters to become

partially or totally ineffective without indication to the wearer. As

the electrostatic charge on the filter fibers is masked by the

deposition of aerosol, the efficiency of the filter can be reduced to

below the anticipated level of protection, based on the certified

efficiency level. Further, these contaminants have been identified as

solids as well as liquids. With no warning to alert the wearer of a

decrease in the performance level of the filter, these commenters

believed that the proposed tests to determine filter efficiency should

be modified to assure that the filters are tested until the minimum

level of efficiency is achieved. The stated advantage of such an

approach is that filters could be used with any aerosol for indefinite

time periods without concern of filter degradation.

The other school argued that the two proposed categories were

either appropriate or too severe. They suggested continuing with the

two categories either as proposed or with a reduction in the amount of

filter loading (to reduce the severity of the test). They argued that

the two proposed filter tests, being a combination of worst-case and

severe test parameters, would assure adequate filter performance in the

workplace.

Several commenters stated that the great majority of respirator

applications are in worksites with aerosols that do not significantly

diminish the efficiency level of the electrostatic filters. Workplace

studies were submitted to support the conclusion that, because of the

highly degrading nature of DOP and the proposed high loading level, the

proposed test were many times more severe than conditions realistically

encountered by workers. These commenters recommended, not only the

certification of two categories as proposed, but that the proposed test

loading levels for both the NaCl and DOP aerosols be reduced to more

closely simulate workplace exposures.

The advantage of the proposed tests was the benefit of potentially

lower breathing resistance, with the resulting increased comfort, of

electrostatic filters for the great majority of respirator wearers who

are not exposed to highly degrading workplace aerosols. Further, the

electrostatic filter types were reported by commenters to have a

potentially lower cost than their mechanical filter counterparts.

This final rule provides for the needs of both the majority workers

with no need for filters highly resistant to degradation and workers

needing filters most resistant to degradation. To that end, this rule

provides for a third category of filters added to the two categories

provided for in the proposal. The new filter category is tested with

the highly degrading DOP until no further decrease in filter efficiency

is observed.

As discussed under VI. Discussion of Final Rule, D. Section-by-

Section Discussion, Sec. 84.170, NIOSH is introducing a new terminology

for the three filter categories. The solid only filters in the proposal

are labeled N-series filters in this final rule. The proposal's solid

or liquid filters are now labeled R-series filters. Filters of the new,

third category are labeled P-series filters. The three categories,

therefore, provide filters for a complete range of applications.

Further, to address concerns about the use of A, B, and C in the

proposal to indicate the efficiency level, the final rule uses

numerical notations of 100, 99, or 95 to indicate filter efficiency.

The rationale for retaining the proposed efficiency levels of 99.97,

99, and 95% is discussed in VI. Discussion of Final Rule, D. Section-

by-Section Discussion, Sec. 84.170(c)(3). The terminology of this final

rule is related to that of the proposal as follows:

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

Final Proposal

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

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

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

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

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

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

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

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

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

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

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

As stated in the proposal, NIOSH selected the test criteria to be a

combination of worst-case and very severe test conditions. The N- and

R-series filters will be tested to a specified maximum loading level as

in the proposal. Performance of these two filter classes at loadings

beyond that maximum will not be evaluated. Furthermore, NIOSH is aware

that few data are available to assess the performance of these

respirators in workplace settings over an extended period of time.

Therefore, the N- and R-series filters will be certified with the

recognition that in some settings time-use limitations should be

applied. A single shift limitation, for example, may be appropriate to

guard against possible degradation of performance below the efficiency

certified by NIOSH. In addition to possible time-use restrictions, the

N-series filters should be restricted to use in those workplaces free

of oil aerosols because the N-series certification tests will involve

challenge with non-degrading sodium chloride aerosols. The R-series

filters should require no such aerosol-use restrictions because R-

series certification tests will involve challenge with highly degrading

dioctylphthalate aerosols. Because the P-series certification tests

will involve challenge with this highly degrading

[[Page 30343]] aerosol that will continue until the filter efficiency

declines to its lowest level, the P-series may require neither aerosol-

use nor time-use limitations. As for any filter, service time will be

limited by considerations of hygiene and increased breathing resistance

due to filter loading.

Guidelines for the use and selection of part 84 particulate

respirators, as described in V. Administrative and Procedural Matters

of Final Rule, B. User's Guide, are to be developed with public input.

The user's guide will include detailed guidance concerning use

limitations for these three filter series.

D. Section-by-Section Discussion.

All sections redesignated to 42 CFR part 84 without modification

from 30 CFR part 11 are excluded in this discussion of the final rule.

The sections redesignated without modification will be revised, where

appropriate, to:

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

mining applications,

(2) update the NIOSH certifying organization to the Certification

and Quality Assurance Branch, Division of Safety Research, NIOSH, 1095

Willowdale Road, Morgantown, West Virginia 26505-2888,

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

tests for protection during abrasive blasting,

(4) correct nonsubstantive typographical errors and reference the

new part 84 section designations, and

(5) update references to incorporation-by-reference documents.

The sections redesignated without modification are as follows:

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

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

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

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

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

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

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

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

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

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

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

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

84.175, 84.176, 84.178, 84.182, 84.190, 84.191, 84.192, 84.193, 84.194,

84.195, 84.196, 84.197, 84.198, 84.199, 84.200, 84.201, 84.202, 84.204,

84.205, 84.207, 84.250, 84.251, 84.252, 84.253, 84.254, 84.255, 84.256,

84.257, and 84.258.

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

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

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

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

of Federal Regulations (42 CFR).

Subpart A--General Provisions

Section 84.2--Definitions

This section is redesignated and revised from Sec. 11.3. This

section is unmodified from the proposal.

The existing definitions for air contamination level, Bureau,

concentration limits for radionuclides, DOP, MESA, pesticide,

radionuclides, and smoke are deleted. These terms are used in

provisions that are modified or deleted as a result of the filter

penetration test changes included in this final rule. These definitions

have, therefore, become unnecessary.

The existing definition for Testing and Certification Laboratory is

modified to reflect the present name of the organization as the

Certification and Quality Assurance Branch. One commenter suggested the

definition of respirator be modified to require a respirator to have

one-way airflow with inspiratory and expiratory valves, able to be

properly positive and negative fit-checked under usual working

conditions. Additionally, this commenter recommended adding a

definition for mask as any device that protects the wearer against

inhalation of a hazardous atmosphere.

The primary purpose of a respirator is to provide respiratory

protection for the wearer. Neither requiring inhalation and exhalation

valves nor reclassifying respirators as masks would enhance worker

protection. Thus NIOSH retained the current definition.

Section 84.3 Respirators For Mine Rescue or Other Emergency Use In

Mines

This section is new and maintains MSHA's role in the approval of

respirators designed for mine rescue or other mine emergency use. This

section is unmodified from the proposal. Under this provision, MSHA and

NIOSH will conduct joint review and certification of respirators used

for mine emergencies and mine rescue. This provision recognizes MSHA's

expertise in identifying the special needs and considerations for

respirators used in the mining environment. This role replaces MSHA's

existing role as a joint approver of all respirators. Several

commenters, while endorsing the transfer of the authority for the

regulation, recognized MSHA's unique expertise relating to mine-

specific respiratory protective devices. These commenters strongly

supported MSHA's continued close involvement in this equipment

including, but is not limited to, filter self-rescuers, self-contained

self-rescuers, and emergency rescue equipment.

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

any respirator designed for mine emergencies, mine rescue or other

emergency use in mines. This joint review and certification includes

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

documentation. This paragraph further specifies that certifications for

these respirators include any identified use limitations related to

mine safety and health as a condition of certification.

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

and retrofit matters arising from field complaints or identified

deficiencies concerning any respirators used in the mining environment.

A new Memorandum of Understanding is to further delineate MSHA's role

in such matters, including participation in any related field or

manufacturing site audits.

Subpart B--Application for Approval

Section 84.10 Application Procedures

This section is redesignated from existing Sec. 11.10 with only

paragraph (e) modified. This section is unmodified from the proposal.

Paragraph (e) retains the existing requirement for inspection,

examination, and testing by MSHA of electrical and electronic

components to be permissible in accordance with 30 CFR part 18 for

respirators intended for use in mining environments and having

permissible electrical or electronic components. MSHA will continue to

conduct this testing and issue a separate MSHA approval number for

those respirators found acceptable. The process for conducting the

permissibility evaluation of these components and their identification

remains unchanged from the existing policies and practices.

Subpart C--Fees

Section 84.20 Examination, Inspection, and Testing of Complete

Respirator Assemblies; Fees

This section is redesignated from existing Sec. 11.20, and modified

only to reflect the new particulate filter classification scheme. This

section is unmodified from the proposal. [[Page 30344]]

Subpart D--Approval and Disapproval

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

This section is redesignated from existing Sec. 11.33. This section

is unmodified from the proposal.

Paragraph (b) specifies the use of the NIOSH emblem on the approval

label, replacing the MSHA emblem.

Paragraph (e) of this section is modified to identify the existing

dust, fume, and mist class of respirator as a particulate respirator.

The new designation is consistent with the testing criteria under which

these respirators are certified. The table in paragraph (e) identifying

the approval label requirements is modified by the removal of

references specific to paint spray and pesticide respirators, also

consistent with the changes associated with the non-powered air-

purifying particulate filter efficiency level determination test.

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

Atmospheric Hazards; Service Time

Section 84.52 Respiratory Hazards; Classification

This section is redesignated from existing Sec. 11.52. This section

is unmodified from the proposal.

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

pesticide classification is no longer appropriate with the introduction

of the particulates classification.

Subpart G--General Construction and Performance Requirements

Section 84.61 General Construction Requirements

This section is redesignated from Sec. 11.61. This section is

unmodified from the proposal.

The provision for respirator components to meet the permissibility

requirements of 30 CFR part 18 [paragraph (e)] has been deleted because

MSHA's workplace regulations separately and independently establish

this requirement for certain mining applications. This change is

consistent with existing practice, whereby, MSHA conducts the

evaluation and testing of these components and issues a separate

approval to cover this aspect of respirator design.

Subpart I--Gas Masks

Section 84.125 Particulate Tests; Canisters Containing Particulate

Filters; Minimum Requirements.

This section is redesignated from existing Sec. 11.102-4, without

modification except to specify the new requirements that respirators

for protection against particulates (dusts, fumes, mists, and smokes)

in combination with gases, vapors, or gases and vapors, must meet.

Except for reference to the redesignated section numbers of subpart K,

this section is unmodified from the proposal. With the exception of the

airflow resistance test of Sec. 84.181, these respirators are required

to meet the requirements specified in Secs. 84.170 through 84.183.

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

Section 84.170 Non-Powered Air-Purifying Particulate Respirators;

Description

This section, derived from Sec. 11.130, is revised to define non-

powered air-purifying particulate respirators in a more concise way

than previously provided for respirators designed for protection

against dusts, fumes, mists, paint sprays, and pesticides. An essential

benefit to filter-mask purchasers of new certifications under this part

is that they will no longer have to be knowledgeable about the

contaminant particle sizes. Under the provisions of this part, NIOSH

will certify filter performance with a test aerosol size chosen so that

filter performance for essentially all other aerosol sizes will be

higher than that certified by NIOSH.

Paragraph (a) describes non-powered air-purifying particulate

respirators as those with air drawn through the air purifying filter as

a result of the negative pressure generated with the inhalation of the

wearer. Non-powered respirators include respirators that depend solely

on the inhalation and exhalation of the wearer to provide an adequate

supply of purified breathing air to the wearer. These respirators are

designed with filters to provide respiratory protection against

atmospheres that contain adequate oxygen to support life and are

contaminated with particulates not immediately dangerous to life or

health. Particulates for which these respirators provide protection

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

Paragraph (b) establishes three series of non-powered air-purifying

particulate respirators designated as N-series, R-series, and P-series.

The N-series respirators are intended for use in those workplaces free

of oil aerosols. The R-series and P-series respirators are intended for

removal of any particulate that includes oil-based liquid particulates.

Paragraph (c) establishes the classification of non-powered air-

purifying particulate respirators according to the efficiency level of

the filter(s) when tested to the requirements of part 84.

Paragraph (c)(1) requires N100, R100, and P100 filters to

demonstrate a minimum efficiency level of 99.97 percent.

Paragraph (c)(2) requires N99, R99, and P99 filters to demonstrate

a minimum efficiency level of 99 percent.

Paragraph (c)(3) requires N95, R95, and P95 filters to demonstrate

a minimum efficiency level of 95 percent.

As discussed previously, some commenters supported the two-

classification system that was proposed while others stated only one

class was needed. NIOSH agrees with commenters that a class of

respirators should be available for use in environments where the

filter efficiency level is not diminished by the worksite aerosol (N-

series). Insufficient studies have been conducted to definitively

characterize workplace aerosols and their effect upon filter

efficiencies. Therefore, NIOSH will certify the new filter categories

recognizing potential aerosol-use and time-use limitations as discussed

above and in VI. Discussion of Final Rule, C. Filter Classification.

Many commenters expressed concerns of confusion in the selection of

the proposed new particulate respirators. Various commenters pointed to

the proposed multiple (two) classes, class nomenclatures (Solid Only

and Liquid and Solid), type nomenclature (A, B, and C), and filter

color requirements as sources for this confusion.

Several commenters recommended that the designations (A, B, and C)

for the types be changed to eliminate confusion of the particulate

respirator classes with other approved respirator types. Some of these

commenters suggested nomenclatures similar to P3, P2, and P1 used for

particulate filters in the European community. Another of these

commenters recommended a further delineation of the alphabetic notation

with each type and class designated by a unique letter (A, B, C, D, E,

and F) for clarification. Still another commenter suggested that the

nomenclatures be changed but made no specific suggestion.

To address concerns about confusion in the selection of respirators

under part 84, NIOSH has developed new category classifications and

will develop a user's guide, as discussed in V. Administrative and

Procedural Matters of Final Rule, B. User's Guide.

Numerous comments were also received regarding the proposed

efficiency levels. Many commenters [[Page 30345]] supported the three

efficiency levels as proposed, while others suggested levels different

than proposed. A 90% filter efficiency level was the most frequently

recommended alternative, sometimes suggested as a fourth class.

NIOSH recognizes that the efficiency requirements contained in the

proposed rule are to some extent technology-forcing. However, HEPA-

level respirators that perform at an efficiency level proposed under

part 84 have been available for years. One commenter (a manufacturer)

stated that the technology for producing 95% (Class C) efficiency level

respirator is practical, reasonable, and available. This commenter

further stated that a Class C respirator could be marketed at a price

not exceeding the price of a 30 CFR part 11 disposable DFM respirator.

The principal advantage of a 90% efficiency class would be to

permit a larger percentage of filters certified under part 11 to be

certified without modification under the new part 84 tests. The best

performing of the current DM and DFM respirators are expected to meet

the requirements of a 95% class, but a significant number of DM

respirators would not be expected to meet the requirements even of a

90% class. Limiting the minimum filter efficiency to 95% will minimize

worker exposure to airborne contaminants from filter penetration. This

is important because it is the most controllable element of protection

afforded by respiratory protection programs. The human variables in

these programs are more difficult to guarantee: that workers are

provided the appropriate class of respirator; that the workers are

effectively fit tested; that they achieve and maintain an effective

face seal each time they wear a respirator; and that they replace

disposable respirators and filters before their effectiveness is

diminished. Some commenters urged, for these reasons, that all filters

should have greater than 99% efficiency. Such high filter efficiency

poses technologic challenges, increases costs to manufacturers and

users, and increases breathing difficulty for respirator wearers. NIOSH

believes that a 95% minimum efficiency best balances the public health

concern and these competing considerations.

Although a number of manufacturers have indicated they are prepared

now to submit filters for certification under these new test

procedures, there may be some who are not. These manufacturers will

have three years to develop this capacity while they continue to market

their existing products.

Section 84.171 Non-powered Air-purifying Particulate Respirators;

Required Components

This section is redesignated from existing Sec. 11.131, modified

only to incorporate the new terminology of particulates to describe

dusts, fumes and mists. This section is unmodified from the proposal,

except for the title change.

Section 84.177 Inhalation and Exhalation Valves; Minimum Requirements

This section is redesignated from existing Sec. 11.137, modified

only to delete reference to the silica dust tests for single-use

respirators of Sec. 11.140-5. This section is unmodified from the

proposal. The respirator performance requirements of these tests are

replaced by the non-powered air-purifying particulate filter efficiency

level determination test contained in this rule.

Section 84.179 Non-powered Air-purifying Particulate Respirators;

Filter Identification

This section requires the identification of non-powered air-

purifying particulate respirators by labeling with a new classification

system for the series and efficiency of the filters. The new

terminology of non-powered air-purifying particulate respirator

replaces the existing dust, fume, and mist respirator, as discussed

previously.

The requirement for the manufacturer to specify the filter-series

and efficiency level classification in the certification application is

contained in paragraph (a). This classification would include the

series of the filter and the expected efficiency of the filter based on

the test requirements specified in Sec. 84.182.

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

certified non-powered air-purifying particulate respirator is specified

in paragraphs (b)(1) through (b)(9). This labeling defines the

efficiency level achieved in the performance testing (i.e., 99.97%,

99%, or 95%) and the series of the filter (i.e., N, R, or P). This

information is necessary to allow the user to make an informed decision

on selecting the appropriate respiratory protection.

To facilitate this selection process, the P100 filters are color

coded magenta to allow them to be easily distinguished from the other

filter types. The filters other than the P100 can be of any color

except magenta. This color coding is consistent with the present

universally accepted color code convention which identifies the best

performing filters (HEPAs) by their magenta color.

NIOSH has modified these labeling requirements from the proposal in

agreement with the commenters who stated that the labelling should

clearly state the certified efficiency rating numerically and include

the series on the filter, filter package, or respirator box.

One commenter suggested that all classes of certified respirators

should be color coded for user identification; another stated that the

high efficiency filters of each series should be magenta. It was also

requested that color coding as well as letter designation be specified

for all respirators. A more complex color-coding system may add

confusion to the respirator selection process. With the more

descriptive classification identifying labels required by this final

rule, the potential for confusion in selection of the appropriate

respirator has been reduced. Therefore, NIOSH has not adopted these

suggestions.

Section 84.180 Airflow Resistance Tests

Section 84.180 is derived from Sec. 11.140-9. It is modified to

delete the final inhalation resistance requirements. The non-powered

air-purifying particulate filter efficiency level determination tests

are not designed to simulate loading of the filter at the worksite.

Therefore, these requirements are not appropriate with the introduction

of these new tests.

Paragraph (a) provides for determining the inhalation-resistance of

the complete non-powered air-purifying particulate respirator. This

value corresponds to the pressure drop across the complete respirator

mounted on a test fixture with air drawn inward through it at a

continuous rate of 852 liters per minute. Tolerance limits

have been added to the test flow rates as suggested by commenters.

The final rule does not include final breathing resistance limits

as requested in some comments. The final breathing resistances

previously included in the 30 CFR part 11 requirements were based on

filters loading and clogging with a silica dust. The loading

experienced at actual worksites is not represented by such a test. The

inclusion of final breathing resistances as part of a certification

would primarily address two concerns. The first is that the breathing

resistance does not exceed physiological limits or pose undue

discomfort on the wearer. Wearers will replace filters before breathing

resistances reach such levels. The second concern is that the filter

efficiency is still at an acceptable level at the certification final

resistance value. The filter efficiency level determination

[[Page 30346]] and respirator classifications provided for in this rule

are sufficiently severe to alleviate this concern.

One commenter questioned NIOSH's intent for restricting final

inhalation resistance for particulate filters used in conjunction with

chemical cartridges. This commenter pointed to Sec. 84.203 requirements

which specify maximum allowable final inhalation resistances for these

combinations. The final inhalation value is to be measured at the end

of the service life tests for the chemical cartridge portion of the

combination. NIOSH will continue to measure the initial and final

inhalation and exhalation resistances of the combination in conjunction

with the service life test of the chemical cartridge. The inhalation

and exhalation resistances need not be measured for these combinations

in conjunction with the particulate efficiency level determination

tests.

Paragraph (b) states the inhalation resistance of the complete

respirator is not to exceed 35 millimeters of water-column height. The

exhalation resistance of the complete respirator is not to exceed 25

millimeters of water-column height.

The proposed rule would have limited the inhalation and exhalation

resistances to 30 and 20 millimeters of water-column height,

respectively. Several commenters requested that the values be

increased. Increased breathing resistance values will permit the

effective use of presently available filter material in respirators re-

designed to meet the efficiency level determination tests at a

reasonable cost. Others expressed a concern that respirators with

higher breathing resistances are less likely to be fitted properly,

often intentionally due to the discomfort. Commenters expressed that

this may be true in the health-care profession where the use of

certified respirators is new.

The final rule has increased the maximum acceptable breathing

resistance values slightly from the proposed levels to those suggested

by commenters. The proposed resistance levels of 30 and 20 millimeters

of water-column height corresponded to the maximum allowable resistance

values in part 11 for any particulate respirator. The new resistance

levels remain below the acceptable limits for some non-particulate

respirator classes under the existing part 11 provision. For example,

chemical cartridge respirators, which have use patterns similar to

particulate filter respirators, have a maximum initial inhalation

resistance of 40 millimeters water-column height. This increase in

acceptable breathing resistance for particulate respirators will enable

manufacturers to produce respirators meeting the new requirements more

expeditiously and at lower cost than the proposal would have allowed.

This small increase in maximum allowable breathing resistance for

particulate respirators does not add substantially to physiologic

burden for respirator users, and will be compensated by increased

worker protection provided by the new filter efficiency tests and

classification system. The acceptable breathing resistance levels for

the non-particulate respirator classes are not affected.

Section 84.181 Non-powered Air-Purifying Particulate Filter Efficiency

Level Determination

This section is new and specifies the test criteria and acceptable

performance criteria for the new non-powered air-purifying particulate

filter efficiency level determination. This section has been retitled

from particulate instantaneous-penetration-filter test in response to a

comment. The new title more appropriately represents the intent of the

tests in this section to determine the efficiency level of the filters.

Paragraph (a) requires the filter efficiency testing of 20 filters

of each non-powered air-purifying particulate respirator model. Testing

is conducted using a solid sodium chloride or equivalent particulate

aerosol for N-series certification or a dioctyl phthalate or equivalent

liquid particulate aerosol for R-series and P-series certification.

Paragraph (b) requires the filters, including holders and gaskets;

when separable, to be tested mounted on a test fixture in the manner as

used on the respirator. This provides for testing of the assembly in a

configuration as it will be actually used.

Paragraph (c) describes preconditioning requirements for the 20 N-

series filters to be tested. After removal from their packaging, the 20

filters are placed in an environment of 855 percent

relative humidity at 382.5 deg.C for 251

hours. The filters shall be stored in a gas-tight container until

tested. Testing for the filter efficiencies must be performed within 10

hours following preconditioning. These preconditioning requirements

apply only to N-series filters differing from the proposal which would

have had filters of each series subjected to preconditioning.

Paragraph (d) provides for blocking the exhalation valves to ensure

that any valve leakage is not included in the filter efficiency level

evaluation. This only applies when the filters do not have separable

holders and gaskets.

Paragraph (e) specifies the continuous test aerosol flow rates for

the filter efficiency testing. Single filters are tested at a rate of

854 liters per minute; filters used in pairs are tested at

a rate of 42.5 2 liters per minute through each filter.

Paragraph (f) describes the penetration test aerosols and the test

criteria to be used. A sodium chloride or equivalent solid aerosol is

used when testing for filter efficiency for N-series filters. A

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

is specified as the testing agent when testing for filter efficiency of

R- and P-series filters. For P-series filters, the filter efficiency

test will be continued until minimum efficiency is obtained. However,

for N- and R-series respirators it will be terminated when an aerosol

mass of 2005 mg has contacted the filter unit, if minimum

efficiency has not been obtained.

Paragraph (f)(1) identifies the test conditions for the sodium

chloride or equivalent solid aerosol to be at 255 deg.C

and relative humidity of 3010 percent. The aerosol

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

Boltzmann equilibrium state, and the maximum concentration will not

exceed 200 mg/m\3\. The relative humidity of the sodium chloride

aerosol has been changed from the proposal in response to a comment.

This change, a small increase in the relative humidity of the aerosol,

allows testing at the values normally encountered with the test

instruments commonly used.

Paragraph (f)(2) specifies the DOP or equivalent oil liquid

particulate aerosol. The test conditions for the liquid aerosol are

specified to be at 255 deg.C. The aerosol specified to be

used in these tests will be neutralized to the Boltzmann equilibrium

state, and the maximum concentration will not exceed 200 mg/m\3\.

Paragraph (g) specifies the particle size limitations at the test

conditions for the filter efficiency test aerosols. The sodium chloride

aerosol will have a particle size distribution with count median

diameter between 0.0750.020 micrometer and a standard

geometric deviation not exceeding 1.86. The liquid particulate aerosol

has a particle size distribution with count median diameter between

0.1850.020 micrometer and a standard geometric deviation

not exceeding 1.60. NIOSH will make these particle size distribution

determinations at the specified test conditions with a scanning

mobility particle sizer (SMPS) or equivalent. The specification of a

scanning mobility particle sizer represents newer technology than the

[[Page 30347]] differential mobility particle sizer that was specified

in the proposal. This reference to the newer technology was added in

response to comments from the public. NIOSH will accept manufacturer's

size verification data determined by SPMS or an equivalent particle

sizing instrument that provides particle sizing information consistent

with an SPMS.

Paragraph (h) requires the efficiency of the filter (i.e., the

amount of aerosol particles that pass through the filter) to be

monitored and recorded throughout the test period by a suitable

forward-light-scattering photometer or equivalent instrumentation.

Paragraph (i) requires the minimum filter efficiency for each of

the 20 filters to be determined and recorded. The minimum efficiency of

each tested filter is to be greater than or equal to 99.97% for P100,

R100 and N100 filters; 99% for P99, R99 and N99 filters; and 95% for

P95, R95 and N95 filters.

Many comments were received on all aspects of the testing

requirements. Comments were received regarding the proposed loading

levels, test agents, preconditioning requirements, number of filters to

be tested, and test equipment specifications.

The proposal included a statistical treatment of the filter

efficiency test results (U statistic). Thirty filter samples were to be

tested for each certification application. The number of samples tested

and the test statistic used in the treatment of the data was intended

to provide a 95% confidence interval of 95% conformance (95% tolerance

interval) of manufacturers' product to the certification criterion.

These methods rely on the applicability of the ``normal'' or Gaussian

distribution for test data. A similar statistical treatment of the test

data was included in the 1987 NIOSH proposal.

A number of commenters expressed concern with the use of a NIOSH

proposed U statistic (based on a 95% tolerance interval for the 95th

percentile) to determine if the performance of filters submitted by

manufacturers meet the requirements for requested classification

(type). Comments concerned the use of the constant 2.22 for the

calculation of the U statistic, suggesting that this is too strict a

criterion for manufacturers to meet and implying that 95% tolerance

intervals based on some lower percentile (e.g., 90th) would be more

appropriate. Other comments concerned the distribution assumptions

inherent in the calculation of the U statistic. Commenters expressed

concern that the assumption that test data represent a sample from a

Gaussian distribution is incorrect and that the application of

tolerance interval methods for this data is inappropriate.

Other commenters questioned NIOSH's justification to ``knowingly''

allow the certification of respirators that do not meet the performance

requirements. They interpreted the statistical criterion as NIOSH

accepting up to 5% of the distributed respirators to be less than the

stated class minimum. This analysis of the data would imply that some

of the distributed certified respirators perform below the inferred

minimum performance level of its class. The commenters expressed

concern that this would cause an unacceptably large number of workers

to have inadequate respirator protection.

One commenter pointed out that the use of the U statistic was an

attempt to predict future production variability. This commenter

further asserted that respirators submitted for certification testing

do not constitute a random sample of a manufacturer's product.

Production variability, this commenter continued, is to be controlled

by the separate quality control program.

NIOSH concurs with the commenter that the proposed statistical

approach addressing pre-market production samples is inconsistent with

determining product quality in a controlled process. NIOSH further

agrees that the samples submitted for certification testing are not

random samples. Therefore, the final rule does not include an

acceptance criterion based upon the statistical treatment of test data.

A significant portion of the cost attributed to the proposed

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

statistical treatment of data. Manufacturers stated that this cost

impact would be reduced if a 95% tolerance interval based on a 90

percentile (i.e., 95% confidence of 90% conformance) were used.

Manufacturers and others suggested that a pass/fail criterion should be

offered. Several commenters suggested reducing the number of test

samples and using a pass/fail criterion.

A pass/fail criterion is consistent with the current respirator

acceptance criterion, and is generally accepted as appropriate for a

certification program with testing of pre-production units. The pass/

fail criterion presents another advantage in that it establishes the

minimum acceptable performance level consistent with the class

definition. A member of a 95% class will not be in compliance with the

certification if it has an efficiency below that level when tested. The

statistical test criterion could allow some individual units to have

performance test measurements below 95% but still meet certification

requirements.

Based on these comments, NIOSH has reconsidered the use of the

tolerance interval approach for the analysis of respirator performance

data. NIOSH agrees that the application of the tolerance interval

approach is inconsistent with type approval and recognizes that

respirators submitted for certification do not constitute a random

sample of a manufacturer's product. Consequently, the final rule has

been modified to test 20 respirators for laboratory performance, with

certification if all 20 units meet the specifications.

The proposal specified both sodium chloride (NaCl) as the solid

test aerosol and dioctyl phthalate (DOP) as the liquid test aerosol.

Although DOP is a suspected carcinogen, the set up of the test

instruments precludes laboratory personnel exposure to the aerosol.

Sodium chloride does not pose a suspected health hazard. Dioctyl

phthalate is the most severe liquid, or degrading test aerosol known.

It has been used for decades as the test aerosol for certification of

the best (HEPA) part 11 filters. Sodium chloride is a solid test

aerosol that provides some degrading characteristics. Sodium chloride

has also been used for years as the solid test agent in the European

(CEN) certification standards.

No comments were received against the use of NaCl as the solid test

aerosol for non-powered respirators. One commenter, a former employee

of the Department of Defense, questioned its use because the military

does not use it in their mask testing. Another commenter, accepting the

use of NaCl, stated that part 84 should allow equivalent test aerosols

as well. The only negative comments received to the NaCl test aerosol

were due to the difficulties associated with the testing of powered

air-purifying respirators (PAPRs). The requirements for PAPRs was

discussed previously in V. Discussion of Final Rule, B. Powered Air-

Purifying Particulate Respirators.

Commenters interested in the use of certified respirators for

protection against TB suggested the use of biological agents

(bioaerosols) for the certification testing. It is not necessary to

subject filter respirators to a bioaerosol as a condition of

certification. By using test aerosols of the most penetrating size

range, the efficiency-level determination of the certification testing

will be the lowest obtainable for any size aerosol. Therefore, the

efficiency level against [[Page 30348]] any bioaerosol for any

certified respirator will meet or exceed the certified efficiency

level.

Comments concerning the choice of liquid test aerosols were varied.

Several different test agents were suggested including paraffin oil,

Emery 3004, and hydrofluoric acid. Paraffin oil was suggested because

it is consistent with the European (CEN) standards. The U.S. military

has adopted Emery 3004 as a DOP replacement in instantaneous testing of

filter efficiency. A commenter suggested that because hydrofluoric acid

aerosol is common in many industries, it would be a more realistic test

agent.

Each of the suggested alternative liquid aerosols would provide

essentially the same initial or lightly loaded filter efficiency

levels. The initial efficiency level of a filter is defined primarily

by the particle size of the aerosol, not its degrading ability. The CEN

standards use paraffin oil as the liquid test aerosol, but the filters

are not loaded to a significant level. Emery 3004 has been adopted as a

replacement for DOP by the military in initial efficiency testing as

performed for the part 11 HEPA filters. Unlike DOP, none of the

recommended alternative test aerosols provide severe degrading effects

of the filters. This severity is an integral part of the part 84

testing, and addressing the uncertainties of the effects of actual

workplace aerosols.

In considering these options, NIOSH is aware that no single test

agent is used by every prominent standard-setting agency or

organization. The CEN standard uses NaCl as a solid test aerosol. The

current draft for revising the ANSI Z88.8 standard proposes NaCl and

DOP as the test aerosols. No choice of test aerosol would provide

consistency with all other standards, as sought by commenters. A

fundamental purpose of the new testing standards is to assure that at

least one class of filters is highly resistant to degradation by

workplace aerosols. The DOP aerosol was selected for this purpose

specifically because of its severe effect on filter efficiency level.

The proposed alternatives demonstrate less severe effects on the filter

media; therefore, they have been considered inappropriate for the

evaluation intended by NIOSH.

The generation method of dioctyl phthalate aerosol was a concern to

many commenters. Commenters questioned the particle size distribution

for this test aerosol specified in the proposal being greater than that

specified in the existing part 11 requirements. Commenters also

questioned differences in test results based on the use of thermally

generated (hot) or cold-nebulized DOP aerosol. Although the proposal

did not specify any aerosol generation technique to be used for DOP

testing, much of NIOSH's research used as a basis for the proposal was

performed with cold-nebulized DOP and NIOSH testing has demonstrated

that correlation in results obtained between the two aerosol generation

techniques is possible. Some commenters believed that the DOP aerosol

generation method must be specified to ensure reproducible test

results. These commenters used data from Industrial Safety Equipment

Association-sponsored ``round robin'' testing of mechanical and

electrostatic filter material. Complete data and specifics of the round

robin testing were not provided to NIOSH. These tests were conducted

among the majority of the air-purifying respirator manufacturers that

are ISEA members. The test results indicated excellent correlation

between the two aerosol generation methods for efficiency of

standardized mechanical filter media. For standardized electrostatic

media, a divergence in efficiency with increased filter loading was

reported between the two aerosol generation methods. These commenters

also reported that both the initial and stabilized efficiencies of the

electrostatic media correlated well between the two aerosol generation

methods. The divergence reported appears to be a different degradation

rate between the two aerosols.

Moreover, several of the participants provided some additional

insights into the circumstances of the testing. A significant portion

of the manufacturers had recently acquired the cold-nebulized test

instruments. The reproducibility problems reported, they admitted,

could have resulted from operator inexperience. One of the participants

with extensive experience with both aerosol generation methods related

some of the experience gained by that manufacturer. Excellent

correlation is maintained between this commenter's numerous cold-

nebulized DOP instruments in use world-wide. Also, the commenter

reported having encountered no reproducibility problems between

thermally-generated and cold-nebulized instruments in testing

electrostatic media when new DOP is used.

In NIOSH testing, some tests have provided good correlation of

results between the two aerosol generation methods, while others have

not. DOP changes chemically as it ages, becoming less pure. The

thermal-generation method induces a similar chemical change, simulating

accelerated aging of the DOP. Recent NIOSH testing indicates that the

chemically-changed DOP may cause the test instruments to fluctuate from

the stated testing parameters. If monitored closely, and kept within

the specified parameters, equivalent results are obtained with either

aerosol generation method. Therefore, to accommodate these concerns,

the final rule specifies a test using a neat cold-nebulized DOP test,

or equivalent test. Allowing equivalent test methods permits the use of

tests that respirator manufacturers may have already developed. As part

of the established certification process, NIOSH evaluates the test

results submitted by the applicant by comparing them to the results of

NIOSH testing. Any test method yielding results equivalent to the NIOSH

testing will be acceptable.

To further address the testing reproducibility concerns expressed

by commenters, NIOSH is initiating a program whereby a standard

mechanical and electrostatic filter media sample will be made available

upon request for applicant correlation testing. NIOSH will run

characterization tests on these standardized media and send a data

sheet showing the test results with the samples. NIOSH has

traditionally conducted correlation testing for applicants requesting

such testing to document the agreement of their test instruments and

procedures and those of NIOSH. This new procedure will continue the

service provided to the applicants of assuring that the results they

obtain on their instruments and with their procedures provide results

comparable with NIOSH's certification tests. This new process will

reduce the NIOSH resource requirements for corroborating the test

results of the large number of applicants that NIOSH anticipates will

be requesting this service and expedite the correlation process.

Several comments were received on the humidity preconditioning

requirement for filters. One commenter stated that the proposed

preconditioning time (24 hours) was inadequate to have much of an

effect on the performance of electrostatic filter media. The commenter

suggested a thirty-day preconditioning period. Information provided

regarding the ISEA round-robin testing stated that the effects of the

preconditioning were insignificant when testing with the DOP aerosol.

This assessment agrees with NIOSH testing experience. The other

commenters had concerns that the proposal did not provide: detail

regarding uniform preconditioning, the size of the container, the

allowable time after conditioning at which filter media must be placed

within the container and [[Page 30349]] the allowable time for the

filter to remain within the container until tested.

The final rule has been modified to require only N-series filters

be taken out of their packaging and humidity preconditioned prior to

filter efficiency level testing at 855 percent relative

humidity at 382.5 deg.C for 251 hours. The

final rule states that following the preconditioning, the filters shall

be sealed in a gas-tight container and tested within 10 hours. R- and

P-series filters do not have to be preconditioned because they are

tested against DOP which is much more severe than humidity in regard to

reducing filter efficiency. The preconditioning requirement is retained

for the N-series filters to address the effect of humidity on the

filter's efficiency because the sodium chloride aerosol is less severe

than DOP in reducing filter efficiency. The 10-hour limitation on

storage of the filters before efficiency testing will eliminate the

variability concerns.

The final rule has been modified to specify a scanning mobility

particle sizer (SMPS) or equivalent, as recommended by commenters, to

be consistent with the latest technology. One commenter suggested a

flame photometer be allowed for measurement of sodium chloride. The

same commenter also stated that other sizing devices such as the

Tyndall Owl have been used for years and should be an acceptable

measuring instrument. NIOSH is aware that other instrumentation can

provide sizing information that can equate to the values specified in

the rule. In specifying the particle size, it is important to identify

the technology used in its determination. The differential mobility

particle sizer (DMPS) was specified in the proposed rule because this

is the technology traditionally used by NIOSH to determine the particle

sizes of this test. The use of these other instruments is acceptable

and all other such equipment does not have to be specified in the final

rule. To make size verification measurements manufacturers may use any

particle sizing instrument that provides particle sizing information

consistent with an SPMS.

Subpart L--Chemical Cartridge Respirators

Section 84.203 Breathing Resistance Tests; Minimum Requirements

This section is redesignated from existing Sec. 11.162-1. This

section is unmodified from the proposal.

It is modified only to delete reference to various classifications,

such as paints and pneumoconiosis and fibrous producing dusts, that are

no longer appropriate with the introduction of the particulates

classification with the new instantaneous-penetration test.

Section 84.206 Particulate Tests; Respirators With Filters; Minimum

Requirements; General

This section is redesignated from existing Sec. 11.162-7. This

section is unmodified from the proposal. It is modified only to delete

reference to various classifications, such as paints and pneumoconiosis

and fibrous producing dusts, that are no longer appropriate with the

introduction of the particulates classification with the new

instantaneous-penetration test.

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

and Combination Gas Masks

This subpart has been added to continue the part 11 requirements

for the existing dust, fume, and mist; pesticide; paint spray

respirators and combination gas masks during the transition period to

part 84.

These sections are derived from existing 30 CFR part 11, subpart K.

They are modified to update them to part 84 section numbers.

This subpart also included the upgraded requirements for PAPRs to

include only high efficiency filters (HEPA).

Derivation Table

The following derivation table lists (1) each section number of the

final rule (New Section); and (2) the section number of the existing

standard from which the proposed standard is derived (Old Section).

Derivation Table

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

New section Old section

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

42 CFR 30 CFR

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[[Page 30350]]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

84.180........................... 11.140-9

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

84.182........................... 11.140-10

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

84.1130.......................... 11.102-4, 11.130, 11.170

84.1131.......................... 11.91, 11.131, 11.171

84.1132.......................... 11.95, 11.132, 11.175

84.1133.......................... 11.96, 11.133, 11.176

84.1134.......................... 11.97, 11.134, 11.177

84.1135.......................... 11.98, 11.135, 11.178

84.1136.......................... 11.99, 11.136, 11.179

84.1137.......................... 11.100, 11.137, 11.180

84.1138.......................... 11.101, 11.138, 11.181

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

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

84.1141.......................... 11.140-1

84.1142.......................... 11.140-2

84.1143.......................... 11.140-3

84.1144.......................... 11.140-4

84.1145.......................... 11.140-5

84.1146.......................... 11.140-6

84.1147.......................... 11.140-7

84.1148.......................... 11.140-8

84.1149.......................... 11.140-9

84.1150.......................... 11.140-10

84.1151.......................... 11.140-11

84.1152.......................... 11.140-12

84.1153.......................... 11.102-4

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

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

84.1156.......................... 11.183, 11.183-1, 11.183-3,

11.183-4, 11.183-5, 11.183-6,

11.183-7

84.1157.......................... 11.162, 11.162-1, 11.162-4,

11.162-5, 11.162-6, 11.162-8

84.1158.......................... 11.162-7

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

Distribution Table

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

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

number of the final rule (New Section).

Distribution Table

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

Old section New section

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

30 CFR 42 CFR

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11.102-4......................... 84.125, 84.1130, 84.1153

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

[[Page 30351]]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11.140-1......................... 84.1141

11.140-2......................... 84.1142

11.140-3......................... 84.1143

11.140-4......................... 84.1144

11.140-5......................... 84.1145

11.140-6......................... 84.1146

11.140-7......................... 84.1147

11.140-8......................... 84.1148

11.140-9......................... 84.180, 84.1149

11.140-10........................ 84.182, 84.1150

11.140-11........................ 84.1151

11.140-12........................ 84.1152

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11.162-1......................... 84.203, 84.1157

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

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

11.162-4......................... 84.1157

11.162-5......................... 84.1157

11.162-6......................... 84.1157

11.162-7......................... 84.206, 84.1158

11.162-8......................... 84.207, 84.1157

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

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

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

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

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

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

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

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

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

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

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

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

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

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

11.183-1......................... 84.1156

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

11.183-3......................... 84.1156

11.183-4......................... 84.1156

11.183-5......................... 84.1156

11.183-6......................... 84.1156

11.183-7......................... 84.1156

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

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

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

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

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

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

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

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

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

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

VII. Executive Order 12866 and Regulatory Flexibility Act

Section 1 of Executive Order 12866 requires that before

promulgating a new regulation, an agency must weigh many competing

factors. In particular, the agency must assess the need for the

regulation, identify and assess alternatives, determine whether the

regulation is designed to achieve the agency's objectives in the most

cost-effective manner, and, to the extent feasible, use performance

standards. In addition, Section 5 of the Order requires an assessment

of the burden imposed by existing regulations, to identify those that

have become unjustified or unnecessary as a result of changed

circumstances. The Regulatory Flexibility Act (the Act) also requires

that the agency periodically review existing regulations and consider

reforming those that burden small entities, taking into account the

degree to which technology or other factors have changed in the area

affected by the rule. NIOSH is promulgating these regulatory changes in

compliance with both sections of the Executive Order and the Act.

Dose-response data are inadequate to permit a quantitative

description of the risks that would be faced by American workers if

respirators were not used. Neither are there dose-response data that

can support a quantitative description of the risk reduction that will

be achieved by the revised filter performance standards in 42 CFR part

84. Employers frequently lack the economic means or the technical

expertise to make detailed workplace hazard assessments. For the great

majority of occupational settings, environmental data on the airborne

concentrations of toxic materials are completely lacking. When exposure

data are available, they tend to be limited at best. Consequently, it

is difficult to establish quantitative exposure-response relationships.

Most often, occupational exposure data demonstrate the association

between exposure and response, but do not support a precise exposure-

response curve. Extrapolation from exposure to dose is subject to even

greater uncertainty. The variability in exposure between and within

workplaces, exposures over long working lifetimes, possibly

inconsistent or improper use of respiratory protection, and undetected

episodes of substandard respirator performance, among other factors,

all make it very difficult to determine what a worker's dose may be

even if there are measured exposure levels.

Employers, both large and small, rely upon respirators to protect

their employees from airborne toxic contaminants. The preferred and

most effective means of protecting workers is to prevent hazards

entering their breathing zone in the first place, but it is not

technologically or economically feasible in all instances to reduce

airborne concentrations to safe levels. In those workplaces,

respiratory protection is required to minimize workers' risks of acute

and chronic health effects. Although the incremental risk reduction

associated with this rulemaking cannot be quantified, it is evident

that increased filtering efficiency and enhanced filter reliability

must increase the margin of safety for respirator users.

As the last, and occasionally the only, defense against some acute

and chronic health hazards at work it is important that respirators be

reliable and that they perform in the manner and to the extent the user

and employer expect. If respirators fail to perform as expected, the

user will be at greatly increased risk of suffering serious, sometimes

fatal, [[Page 30352]] occupational disease or injury. In most

circumstances the respirator user has no way of knowing if respirator

performance is substandard. Except for the most acute responses to

substandard respirator performance, it is not possible to attribute

health effects to a failure of respiratory protection. Most of the

serious occupational diseases have long latency periods, so respirator

users typically would not know if they used an inferior device. Even

the relationship to workplace exposures can be obscured because of the

presumption that respirators provide effective protection.

Respriator purchasers and users expect and deserve to be able to

select respirators with complete confidence that they will perform with

a specific efficiency for a specific purpose. They rely on the NIOSH,

formerly MSHA/NIOSH, performance standards and certification program to

assure them that they can have that confidence.

These new particulate filter efficiency tests are needed to reduce

potential health risks that may result from leakage of small

particulates through some filters certified under the current

regulations (30 CFR part 11). For over a decade the filter penetration

tests contained in 30 CFR part 11 have been known to be deficient.

Leakage of small aerosols has been recognized as a problem that could

be corrected only by revising that regulation.

The magnitude of the filter leakage problem came into sharper focus

in the early 1990's when NIOSH and other researchers used modern

methods not available under the provisions of part 11 to measure

performance over a range of particle sizes. For certain models,

leakages higher than 50% were found. Not all respirator models exhibit

this high level of leakage, but 30 CFR part 11 testing does not

distinguish adequate from inadequate filters.

The respirator community acknowledges filter leakage to be a

problem. The American National Standards Institute (ANSI) Z88.2-1992

national standard, for example, states that 2 of the 3 types of

particulate respirators certified under 30 CFR part 11 should be used

only when the workplace particulate contaminant is know to have a mass

median aerodynamic diameter (MMAD) greater that 2 micrometer.

Compliance with aerosol size limitations such as those of the ANSI

Z88.2 would represent a major technologic and economic burden for

respirator users. Those burdens are great even for the largest

employers and exceed the capacity of smaller employers. Adequate worker

protection with DM and DFM respirators certified under 30 CFR part 11

can be assured only if employers conduct sophisticated and expensive

measurements of the size distribution of the aerosol in each workplace.

This is simply too expensive for the great majority of respirator

users, who may elect to use DM or DFM respirators without evaluating

aerosols in their workplaces, thereby placing their workers at

increased risk of occupational disease or disability. The only

alternative at present is for those employers to provide costly high

efficiency (HEPA) filters. The difficult and costly aerosol size

measurements are not needed when HEPA filters are used because they are

tested with the most penetrating size of aerosol. HEPA filters are

therefore known to be effective against any aerosol regardless of size.

The new 42 CFR part 84 filter efficiency tests use only the most

penetrating aerosol size, so all filters certified under these new

procedures will be effective against any size aerosol. This new rule

thereby corrects an acknowledged deficiency in existing filter

efficiency tests, removes from the workplace respirators that fail to

deliver the expected degree of worker protection, relieves employers of

the need to perform costly and difficult measurements of aerosol size

distribution, and provides alternatives to the expensive HEPA filters

in workplaces where the aerosol size is either unknown or is known to

be small.

This new rule continues to limit, as does the current 30 CFR part

11, the breathing resistance (inhalation and exhalation resistance) of

the respirator. Breathing resistance is significant to respirator

wearers in three ways. First, higher breathing resistance increases

leakage at the face seal of the respirator. Face seal leakage is

directly proportional to breathing resistance, other factors being

equal. Second, respirators with lower breathing resistance are more

comfortable and more acceptable to wearers. If a respirator is

uncomfortable to wear, workers are less inclined to use their

respirator as often as they should. Third, high breathing resistance

can be an unacceptable physiological burden on some workers. For a

worker with impaired pulmonary or cardiovascular function, high

breathing resistance may make respirator use impossible. In this rule,

NIOSH has increased the allowable inhalation and exhalation resistance

in consideration of minimizing economic impact, but NIOSH has

maintained the breathing resistance at a level that still will minimize

adverse impacts on the respirator user.

E.O. 12866 further requires the agency to determine whether the

proposed rule is ``economically significant'' (e.g., it does not have

an annual effect on the economy of $100 million). NIOSH generally

prepares a regulatory flexibility analysis, in accordance with the Act,

if the rule is expected to have a significant impact on a substantial

number of small entities. NIOSH does not believe that this final rule

will have an annual impact on the economy of $100 million, nor does

NIOSH believe that the rule will have a significant impact on a

substantial number of small firms.

This regulatory change affects only particulate respirators. A

total of 56 manufacturers hold respirator approvals, and 33 of these

hold approvals for particulate respirators. Based on inquiries

received, NIOSH believes that several additional manufacturers are

planning to submit applications for particulate filter products under

this new regulation.

Data are not available to define company size, market share, or

diversity of products for the current approval-holders. Projections of

impact are based on an understanding of manufacturers dependence on

existing approved particulate respirators. Of the 33 manufacturers that

have particulate filer approvals, 24 hold additional approvals for

devices other than particulate respirators, and nine have only

particulate filter approvals. One of these manufacturer holds approvals

for DM, DFM and HEPA respirators, while the remaining eight each hold

only a single particulate filter approval. Because all existing HEPA

filters are expected to pass the new certification tests, it appears

that only eight of 56 respirator manufacturers might be dependent upon

particulate filter respirators possibly at risk of not passing the new

certification tests without redesign. At least one of these eight

manufacturers commented favorably on this proposed rule, indicating

readiness to meet these new criteria.

Any manufacturer that cannot meet the new criteria immediately will

have three years in which to develop new products or face removal from

the approved respirator market. However, loss of approved respirator

status does not prohibit sales of the devices as non-approved units.

The non-approved respirator market appears to be very lucrative, with

several of the larger manufacturers participating. Non-approved

respirators are sold in many retail outlets including hardware, auto

supply, and department stores. Consumers purchase these devices for use

against nuisance dusts while [[Page 30353]] performing various home and

hobby-related activities.

While some current respirator manufacturers may experience negative

impacts, other manufacturers that are not now approval holders have

indicated an intention to enter this market. The new rule thus will

stimulate competition as new technologies are introduced and new

markets are developed. Furthermore, this rule enhances the ability of

domestic manufacturers to compete globally, especially in the European

Community. NIOSH expects to see more new approval holders develop as a

result of the new rule.

A high percentage of the respirator manufacturers are large

corporations or subsidiaries and are international in nature, although

several employ 100 or fewer persons. NIOSH does not have an estimate of

the total number employed by the 33 manufacturers of particulate

respirators. Neither does NIOSH have any indication of how many

employees are engaged solely in the manufacture of particulate

respirators. However, the respirator manufacturing industry in general

is mature and stable. A 1982 survey of the industry performed for NIOSH

covered 29 firms that were active at that time, the majority of which

continue to manufacture respirators in 1995. Of these, 12 were

subsidiaries of larger firms. Median total employment was 375. A large

portion of these workers were believed to be engaged in activities

unrelated to particulate respirator manufacturing. Sales figures

indicated respirator sales ranged from less than 1% to 10-15% of total

corporate sales.

NIOSH believes the industry profile remains basically the same it

was in 1982. That is, respirators do not represent the primary source

of sales income for any of the manufacturers that will be affected.

Because respirators represent a low percentage of overall sales, the

percentage of total employees involved in the manufacture of

respirators is believed also to be low. Therefore, few employees are

likely to be severely impacted by the new rule. Indeed, the increased

competition and opening of markets expected to result from the rule may

well enhance aggregate employment for both current and new approval

holders.

Most employers rely on government standards to determine acceptable

levels of respirator performance. It would be inefficient and

unreasonably costly for each of millions of occasional purchasers of

these inexpensive devices to independently attempt to determine which

devices operate effectively to filter out submicron toxic particles.

This rule removes a regulatory impediment to the improved design of

respirators by substituting a performance standard for an obsolete

specifications standard. The practical effect of this will be to enable

firms to substitute a more effective and efficient filter material in

lower-cost respirators. Respirators already using high efficiency

filters meeting 30 CFR part 11 requirements will not be affected by

this proposal. These respirators will not require modification to be

certified under this final rule, although the certification may not be

at the new P100 efficiency level. Although the category of performance

may be reduced from the previous HEPA rating, no design or development

costs are associated with the certification of these products.

NIOSH received limited responses to its request for comments and

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

improved respirators. Several respirator manufacturers referred to a

survey conducted by their trade association as suggesting that costs of

this module would exceed $100 million, but specific cost estimates for

this module were not provided. The trade association reported that

their estimate was based largely on the surveyed manufacturers'

projections of procuring new equipment, procuring new materials, plant

retooling, and the like. The largest manufacturer of respirators did

not project the same cost impact on its products, even though that

manufacturer recommended changing the proposed rule to eliminate the

least costly class of proposed respirators and to increase the severity

of two testing parameters. Another manufacturer stated that the

``projected increased user cost for disposables of 42 CFR part 84 would

be between $440 and $990 million,'' based solely on impacts to that

manufacturer's products. This manufacturer forecast that prices to end

users would rise by 1.7- to 2.9-fold or 9- to 16-fold depending on

filter type.

Very limited data were submitted in support of any of these

estimates, but it appears that the large discrepancy between NIOSH and

industry cost estimates are attributable to 3 principal factors:

(1) Cost estimates by industry included many capital investmet

costs rather than recurring annual costs, inclusion of which improperly

inflated the annual cost projections.

(2) An erroneous assumption made by the manufacturer projecting the

greatest cost impact. That manufacturer assumed that the proposed fit

test would require all disposable respirators to have an elastomeric

flange. Additional costs attributed to consumer reaction to this

assumption were:

(a) expensive reusable elastomeric cartridge respirators replacing

inexpensive disposable models, and

(b) costly respirator maintenance and training programs associated

with reusable respirators.

Neither NIOSH nor other manufacturers projected either of these as

a consequence of the fit testing. In any event, the requirement for fit

testing was eliminated from the final rule. That represents a cost

saving in itself but this change also renders moot the question of

elastomeric flanges for disposable respirators.

(3) Two additional elements of the proposed rule were identified as

having significant cost impact: statistical evaluation of certification

test results and limitations on inhalation/exhalation resistance. These

were changed in the final rule to eliminate the statistical criterion

and to adopt the inhalation/ exhalation resistance levels requested by

the manufacturers. As a result and as discussed below under specific

topics, NIOSH does not believe that this rule will approach the $100

million threshold. In fact, NIOSH believes that over time

manufacturers' costs and prices to users will fall.

Commenters stated that the statistical treatment of test data as

included in the proposal would ``add greatly to the cost of filters and

respirators.'' One commenter estimated that the added manufacturing and

waste costs attributable to this provision would be 25-30% of the costs

attributable to the proposal. According to the commenters, the

replacement of the proposed statistical treatment of test data with the

less stringent statistical treatment proposed by NIOSH in 1987 or a

pass/fail criterion would remove the added cost implications of the

proposed rule.

As discussed previously, NIOSH has replaced the proposed

requirement for the statistical treatment of test data with the

recommended pass-fail criterion. Twenty filters are to be tested,

reduced from 30 to be required under the proposal. This change in the

final rule, based on technical concerns discussed previously, will

significantly reduce the cost implications of the final rule from the

estimated costs of the proposal.

The fit test requirements proposed under Secs. 84.181 and 84.182

were identified as another source of a significant portion of the costs

attributed to the proposed rule. The increased costs resulted from the

interpretation that the isoamyl acetate testing would necessitate

elastomeric inner flanges to be added to all certified disposable

respirators in all categories. [[Page 30354]] This interpretation led

to two conclusions that increased the cost estimates. The first

conclusion was that all disposable filter respirators would need to be

redesigned to include a costly elastomeric facepiece. The estimated

increased costs of disposable respirators led to the second conclusion

that the currently inexpensive and widely used disposable particulate

respirators would be replaced by costly reusable elastomeric cartridge

masks. This increased use of reusable masks was estimated to increase

users' costs of respirator maintenance and training programs not

associated with disposable respirators. The costs associated with the

use of an isoamyl acetate represented a substantial portion of the

projected cost impact of the proposed rule.

As discussed earlier, NIOSH has reconsidered the proposed

requirement for isoamyl acetate fit-testing of these respirators. Based

on technical considerations, the isoamyl acetate tests have not been

included in the final rule. NIOSH anticipates that currently accepted,

fit-testing procedures will continue to be used to assure a proper

respirator-to-face seal for each respirator user. Based on prior

experience with currently certified disposable respirators using these

procedures, no redesign of the facepiece seal of disposable respirators

will be required as a result of this final rule. Therefore, the cost

implications attributed to the isoamyl acetate fit tests are not

applicable to this final rule.

It is our understanding that substituting better filter material

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

run. The material costs may be slightly increased, but are relatively

small compared to those estimates for statistical evaluation and fit

testing. The costs associated with these latter two have been greatly

reduced by the requirements in the final rule.

The demonstrated level of performance for filters will be

substantially more effective. Instead of an efficiency rate of 95

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

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

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

percent. The importance of this change will vary considerably from

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

benefits will be considerable.

For example, the classes of particulate filter respirators

certified under this rule will meet or exceed the recommendations for

respiratory protective devices used for M. tuberculosis. Of the

currently NIOSH-certified respirators, only high-efficiency particulate

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

certification to an enhanced performance level will create options for

the choice of respirators that adhere to the recommendations at reduced

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

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

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

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

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

bulk. Costs for a N95 filter are expected to be less than those of a

current HEPA filter. Applications of new filter technologies and market

competition is expected to generally have the impact of reducing the

cost of the new respirators. At least one commenter has already

indicated that the 95% efficiency level respirators will be priced not

exceeding the cost of 30 CFR part 11 disposable DFM respirators, $5 to

$8 each.

NIOSH would expect similar effects--both improved health and cost

avoidance--in many other settings. NIOSH estimates that as many as

seven million workers use respirators at some time each year. NIOSH

estimates that employers annually purchase over 110 million disposable

respirators.

There are approximately 35 manufacturers of these respiratory

devices. Most of these already possess or have access to test equipment

needed to perform the new filter tests. As is currently required under

30 CFR part 11, NIOSH will continue to require that applicants conduct

or have conducted examinations, inspections, and tests of respirator

performance at least equivalent to those set by the respirator

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

development is conducted by the applicant prior to submitting an

application to the Federal Government for testing of the respirator by

NIOSH. For those manufacturers that do not currently possess this

capability, NIOSH estimates that the purchase of this equipment

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

this would not represent a significant cost for most manufacturers.

Commenters indicated that the projected costs of new, updated test

instruments for the filter efficiency testing contributed significantly

to the costs reported to be attributable to the proposed rule. NIOSH

agrees that if manufacturers opt to purchase newly developed

instruments, this represents a significant investment. As discussed

previously, the filter efficiency tests of this final rule can be

conducted using the instrumentation previously specified for the

testing of high efficiency filters under 30 CFR part 11. Therefore, the

purchase of new test instruments is not required for most

manufacturers. Further, the purchase of test instruments represents a

capital investment amortized over time, not an annual recurring cost.

Filter materials are currently available that can be substituted

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

performance requirements of the new tests. Some currently NIOSH-

certified respirators have, when tested using the new standards,

demonstrated acceptable performance. Therefore, little or no cost will

be needed to develop suitable filtration materials or redesign existing

devices. However, NIOSH does realize that additional development and

redesign costs may be incurred to augment the presently available

products. NIOSH specifically requested relevant data and comments on

projected costs of redesign of respirators.

One commenter cited the cost of commercially available filter media

to meet the proposed standards as dramatically increased over the

present cost of the existing 30 CFR part 11 disposable dust/mist

requirements. The cost of present dust/mist media was stated as between

60 cents and one dollar per square yard, whereas the cost of

commercially available filter media to meet the proposed 42 CFR part 84

requirements is between 12 dollars and 17 dollars per square yard,

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

``solids'' or ``liquid/solids'' category. Two other commenters

indicated the availability of prototype respirators and filters that

could be marketed for little or no cost increase from existing dust/

fume/mist respirators and filters.

Several comments were received stating that the combination of

proposed initial inhalation and exhalation resistance limits and

efficiency levels might require increasing the surface area of filters.

It was asserted that an increase in filter surface area to meet these

requirements would ``increase substantially the raw material and

manufacturing costs of respirator protection.'' For the technical

reasons discussed previously, the initial inhalation and exhalation

resistances have been increased in the final rule to the values

recommended by these commenters. Adoption of these values will allow

``latitude to develop filters at [[Page 30355]] a reasonable cost

without compromising safety or comfort to the user,'' according to the

comments.

In summary, NIOSH did not believe the proposed rule change was

``economically significant'' within the definition of E.O. 12866 based

on the cost projections attributable to the proposal that were provided

to NIOSH and those modifications incorporated into the final rule.

Notwithstanding these general conclusions, there may be some

manufacturers that will find it financially difficult, or a poor

investment, to meet the new standards. NIOSH expects such problems to

result from free market competition rather than the specific standards

of these final regulations. That is, most knowledgeable employers would

purchase more cost-effective respirators voluntarily and force major

changes in the market if the present regulatory barriers were removed.

List of Subjects in 42 CFR Part 84

Administrative practice and procedure, Incorporation by reference,

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

Personal protective equipment, Reporting and recordkeeping

requirements, Respirators.

Dated: April 14, 1995.

Philip R. Lee,

Assistant Secretary for Health.

Dated: April 14, 1995.

Donna E. Shalala,

Secretary.

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

read as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Subpart A--General Provisions

Sec.

84.1 Purpose.

84.2 Definitions.

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

Subpart B--Application for Approval

84.10 Application procedures.

84.11 Contents of application.

84.12 Delivery of respirators and components by applicant;

requirements.

Subpart C--Fees

84.20 Examination, inspection, and testing of complete respirator

assemblies; fees.

84.21 Examination, inspection, and testing of respirator components

or subassemblies; fees.

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

approval.

Subpart D--Approval and Disapproval

84.30 Certificates of approval; scope of approval.

84.31 Certificates of approval; contents.

84.32 Notice of disapproval.

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

84.34 Revocation of certificates of approval.

84.35 Changes or modifications of approved respirators; issuance of

modification of certificate of approval.

84.36 Delivery of changed or modified approved respirator.

Subpart E--Quality Control

84.40 Quality control plans; filing requirements.

84.41 Quality control plans; contents.

84.42 Proposed quality control plans; approval by the Institute.

84.43 Quality control records; review by the Institute; revocation

of approval.

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

Atmospheric Hazards; Service Time

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

84.51 Entry and escape, or escape only; classification.

84.52 Respiratory hazards; classification.

84.53 Service time; classification.

Subpart G--General Construction and Performance Requirements

84.60 Construction and performance requirements; general.

84.61 General construction requirements.

84.62 Component parts; minimum requirements.

84.63 Test requirements; general.

84.64 Pretesting by applicant; approval of test methods.

84.65 Conduct of examinations, inspections, and tests by the

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

demonstrations.

84.66 Withdrawal of applications; refund of fees.

Subpart H--Self-Contained Breathing Apparatus

84.70 Self-contained breathing apparatus; description.

84.71 Self-contained breathing apparatus; required components.

84.72 Breathing tubes; minimum requirements.

84.73 Harnesses; installation and construction; minimum

requirements.

84.74 Apparatus containers; minimum requirements.

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

minimum requirements.

84.76 Facepieces; eyepieces; minimum requirements.

84.77 Inhalation and exhalation valves; minimum requirements.

84.78 Head harnesses; minimum requirements.

84.79 Breathing gas; minimum requirements.

84.80 Interchangeability of oxygen and air prohibited.

84.81 Compressed breathing gas and liquefied breathing gas

containers; minimum requirements.

84.82 Gas pressure gages; minimum requirements.

84.83 Timers; elapsed time indicators; remaining service life

indicators; minimum requirements.

84.84 Hand-operated valves; minimum requirements.

84.85 Breathing bags; minimum requirements.

84.86 Component parts exposed to oxygen pressures; minimum

requirements.

84.87 Compressed gas filters; minimum requirements.

84.88 Breathing-bag test.

84.89 Weight requirement.

84.90 Breathing resistance test; inhalation.

84.91 Breathing resistance test; exhalation.

84.92 Exhalation valve leakage test.

84.93 Gas flow test; open circuit apparatus.

84.94 Gas flow test; closed circuit apparatus.

84.95 Service-time test; open circuit apparatus.

84.96 Service-time test; closed circuit apparatus.

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

circuit apparatus; maximum allowable limits.

84.98 Tests during low temperature operation.

84.99 Man tests; testing conditions; general requirements.

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

84.101 Man test 5; requirements.

84.102 Man test 6; requirements.

84.103 Man tests; performance requirements.

84.104 Gas tightness test; minimum requirements.

Tables to Subpart H of Part 84

Subpart I--Gas Masks

84.110 Gas masks; description.

84.111 Gas masks; required components.

84.112 Canisters and cartridges in parallel; resistance

requirements.

84.113 Canisters and cartridges; color and markings; requirements.

84.114 Filters used with canisters and cartridges; location;

replacement.

84.115 Breathing tubes; minimum requirements.

84.116 Harnesses; installation and construction; minimum

requirements.

84.117 Gas mask containers; minimum requirements.

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

minimum requirements.

84.119 Facepieces; eyepieces; minimum requirements.

84.120 Inhalation and exhalation valves; minimum requirements.

84.121 Head harnesses; minimum requirements.

84.122 Breathing resistance test; minimum requirements.

84.123 Exhalation valve leakage test.

84.124 Facepiece tests; minimum requirements. [[Page 30356]]

84.125 Particulate tests; canisters containing particulate filters;

minimum requirements.

84.126 Canister bench tests; minimum requirements.

Tables to Subpart I of Part 84

Subpart J--Supplied-Air Respirators

84.130 Supplied-air respirators; description.

84.131 Supplied-air respirators; required components.

84.132 Breathing tubes; minimum requirements.

84.133 Harnesses; installation and construction; minimum

requirements.

84.134 Respirator containers; minimum requirements.

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

fit; minimum requirements.

84.136 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.137 Inhalation and exhalation valves; check valves; minimum

requirements.

84.138 Head harnesses; minimum requirements.

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

requirements.

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

requirements.

84.141 Breathing gas; minimum requirements.

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

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

84.143 Terminal fittings or chambers; Type B supplied-air

respirators; minimum requirements.

84.144 Hand-operated blower test; minimum requirements.

84.145 Motor-operated blower test; minimum requirements.

84.146 Method of measuring the power and torque required to operate

blowers.

84.147 Type B supplied-air respirator; minimum requirements.

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

minimum requirements.

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

class; minimum requirements.

84.150 Air-supply line tests; minimum requirements.

84.151 Harness test; minimum requirements.

84.152 Breathing tube test; minimum requirements.

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

respirators; minimum requirements.

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

respirators; minimum requirements.

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

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

requirements.

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

demand class; minimum requirements.

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

pressure-demand class; minimum requirements.

84.158 Exhalation valve leakage test.

84.159 Man tests for gases and vapors; supplied-air respirators;

general performance requirements.

84.160 Man tests for gases and vapors; Type A and Type AE

respirators; test requirements.

84.161 Man tests for gases and vapors; Type B and Type BE

respirators; test requirements.

84.162 Man test for gases and vapors; Type C respirators,

continuous-flow class and Type CE supplied-air respirators; test

requirements.

84.163 Man test for gases and vapors; Type C supplied-air

respirators, demand and pressure-demand classes; test requirements.

Tables to Subpart J of Part 84

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

84.170 Non-powered air-purifying particulate respirators;

description.

84.171 Non-powered air-purifying particulate respirators; required

components.

84.172 Breathing tubes; minimum requirements.

84.173 Harnesses; installation and construction; minimum

requirements.

84.174 Respirator containers; minimum requirements.

84.175 Half-mask facepieces, full facepieces, hoods, helmets, and

mouthpieces; fit; minimum requirements.

84.176 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.177 Inhalation and exhalation valves; minimum requirements.

84.178 Head harnesses; minimum requirements.

84.179 Non-powered air-purifying particulate respirators; filter

identification.

84.180 Airflow resistance tests.

84.181 Non-powered air-purifying particulate filter efficiency

level determination.

84.182 Exhalation valve leakage test; minimum requirements.

Subpart L--Chemical Cartridge Respirators

84.190 Chemical cartridge respirators; description.

84.191 Chemical cartridge respirators; required components.

84.192 Cartridges in parallel; resistance requirements.

84.193 Cartridges; color and markings; requirements.

84.194 Filters used with chemical cartridges; location;

replacement.

84.195 Breathing tubes; minimum requirements.

84.196 Harnesses; installation and construction; minimum

requirements.

84.197 Respirator containers; minimum requirements.

84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods,

and helmets; fit; minimum requirements.

84.199 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.200 Inhalation and exhalation valves; minimum requirements.

84.201 Head harnesses; minimum requirements.

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

requirements.

84.203 Breathing resistance test; minimum requirements.

84.204 Exhalation valve leakage test; minimum requirements.

84.205 Facepiece test; minimum requirements.

84.206 Particulate tests; respirators with filters; minimum

requirements; general.

84.207 Bench tests; gas and vapor tests; minimum requirements;

general.

Tables to Subpart L of Part 84

Subpart M--[Reserved]

Subpart N--Special Use Respirators

84.250 Vinyl chloride respirators; description.

84.251 Required components.

84.252 Gas masks; requirements and tests.

84.253 Chemical-cartridge respirators; requirements and tests.

84.254 Powered air-purifying respirators; requirements and tests.

84.255 Requirements for end-of-service-life indicator.

84.256 Quality control requirements.

84.257 Labeling requirements.

84.258 Fees.

Subparts O through JJ [Reserved]

Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray; Powered Air-

Purifying High Efficiency Respirators and Combination Gas Masks

84.1100 Scope and effective dates.

84.1101 Definitions.

84.1102 Examination, inspection and testing of complete respirator

assemblies; fees.

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

84.1130 Respirators; description.

84.1131 Respirators; required components.

84.1132 Breathing tubes; minimum requirements.

84.1133 Harnesses; installation and construction; minimum

requirements.

84.1134 Respirator containers; minimum requirements.

84.1135 Half-mask facepieces, full facepieces, hoods, helmets, and

mouthpieces; fit; minimum requirements.

84.1136 Facepieces, hoods, and helmets; eyepieces; minimum

requirements.

84.1137 Inhalation and exhalation valves; minimum requirements.

84.1138 Head harnesses; minimum requirements.

84.1139 Air velocity and noise levels; hoods and helmets; minimum

requirements.

84.1140 Dust, fume, and mist respirators; performance requirements;

general.

84.1141 Isoamyl acetate tightness test; dust, fume, and mist

respirators designed for respiratory protection against fumes of

various metals having an air contamination level not less than 0.05

milligram per cubic meter; minimum requirements. [[Page 30357]]

84.1142 Isoamyl acetate tightness test; respirators designed for

respiratory protection against dusts, fumes, and mists having an air

contamination level less than 0.05 milligram per cubic meter, or

against radionuclides; minimum requirements.

84.1143 Dust, fume, and mist air-purifying filter tests;

performance requirements; general.

84.1144 Silica dust test for dust, fume, and mist respirators;

single-use or

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