National Institute for Occupational Safety and Health; Certification of Respiratory Devices Used to Protect Workers in Hazardous Environments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)

42 CFR Part 84

National Institute for Occupational Safety and Health;

Certification of Respiratory Devices Used to Protect Workers in

Hazardous Environments

AGENCY: National Institute for Occupational Safety and Health (NIOSH),

Centers for Disease Control and Prevention (CDC), Department of Health

and Human Services (DHHS).

ACTION: Notice of priorities for rulemaking.

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SUMMARY: In response to public comments received from its May 16, 1996,

request (61 FR 24740), NIOSH is announcing the intended priority order

for the development of the next proposed rule amendments (modules) to

the current NIOSH procedures for certifying respiratory devices used to

protect workers in hazardous environments. The priority order is based

on the comments and data in the public record. The priority order of

the planned modules is provided to help the respirator community plan

for potential changes.

FOR FURTHER INFORMATION CONTACT: Roland Berry Ann, NIOSH, 1095

Willowdale Road, Morgantown, West

[[Page 53999]]

Virginia 26505-2888, telephone (304) 285-5907.

Availability and access of copies: Additional copies of this notice

can be obtained by calling the NIOSH toll-free information number (1-

800-35-NIOSH, option 5, 9 a.m.-4 p.m. ET); the electronic bulletin

board of the Government Printing Office, (202) 512-1387; and the NIOSH

Home Page on the World-Wide Web (http://www.cdc.gov/niosh/

homepage.html).

SUPPLEMENTARY INFORMATION: NIOSH intends to propose technical modules

in the following areas:

1. Powered Air Purifying Respirator (PAPR)--Establishment of N, R,

and P series filters; Use of active low flow or low pressure warning

devices; and Addition of new duration ratings.

2. Airline Respirator--Single airline for pneumatic devices and

breathing air; Airline suits (i.e., Department of Energy/Los Alamos

National Laboratory suits); Metabolic simulator tests; Air flow/

pressure rate requirements; and Air flow measuring and warning devices.

3. Self Contained Breathing Apparatus (SCBA)--Maximum weight limit,

with accessory definition; Upgrade of cylinder air specifications;

Incorporation of National Fire Protection Association (NFPA)

requirements; Non-facepiece SCBA; Metabolic simulator tests; Air flow/

pressure rate requirements; and Alternatives to Department of

Transportation and Compressed Gas Association requirements.

4. Gas and Vapor Respirator--Certification to a wider variety of

specific substances and addition of service life categories.

NIOSH intends to propose three Administrative/Quality Assurance

modules. The intended subjects for these modules are:

1. Corrections to 42 CFR part 84 and existing program policies not

included in the regulations.

2. Upgrade of Quality Assurance requirements; Use of independent

quality auditors in the certification program and updated fee schedule.

3. Use of independent testing laboratories in the certification

program and restructured fee schedule.

I. Background

On May 16, 1996, NIOSH published a document in the Federal Register

(61 FR 24740) to request public comments on what the agency's

priorities should be in the area of respirator certification. NIOSH

sought public comments on issues of privatization and fees related to

possible changes in its administration of respirator certification, and

comments on establishing priorities for future rulemaking. NIOSH held

three public meetings in June 1996 to discuss these issues. All

comments provided in response to the notice were considered in

developing the rulemaking priorities.

II. Public Comment on Priority Issues

Thirty-two commenters responded to the document including: eleven

respirator manufacturers, seven private sector testing and

certification laboratories, five safety professionals, two public

utilities, two trade or manufacturers' associations, one Federal

agency, one National Laboratory, one fire department, one professional

society, and one respirator accessory manufacturer.

III. Ranking Criteria for Technical Modules

NIOSH requested input on what determinants should be used as the

criteria to rank the priority of each module, in addition to

recommendations for module subject areas. The determinants for ranking

listed in the notice were; consideration of the number of persons

(workers) affected, the seriousness of hazards or problems that would

be addressed, the extent to which changes would improve protection,

opportunity for cost savings (reducing costs for manufacturers and

purchasers of respirators) and the expediency by which a change could

be implemented (e.g., the existence of adoptable consensus standards).

NIOSH specifically sought comments on the following issues for

prioritizing the development of modules: the criteria to prioritize

each module, existing national or international standards that could be

adopted to replace current NIOSH certification requirements, and public

health effects of any recommended changes.

A. Discussion of Comments Received

Commenters generally agreed with the determinants listed in the

notice. Two commenters stated that allowing flexibility of design and

innovative approaches to design and use, as well as encouraging new

product development should be included in the priority ranking

criteria.

B. Conclusions

NIOSH believes that the ability to use innovative approaches and

flexibility in design results in new product development. Performance

standards allow manufacturers to use innovative approaches and

flexibility in design, resulting in new products to address hazards.

NIOSH intends to develop performance-based technical criteria to the

extent possible in its rulemaking activities. Therefore, although

neither of these suggestions were included as determinants in the

priority ranking criteria, NIOSH expects both will result from the

rulemaking activities.

The ranking criteria used to develop the module priority order was:

the number of workers affected, the seriousness of hazards or problems

that would be addressed, the extent to which changes would improve

protection, the expediency by which a change can be implemented (e.g.,

the existence of adoptable consensus standards), and opportunity for

cost savings (reducing costs for manufacturers and purchasers of

respirators).

IV. Technical Module Priority

NIOSH requested input to develop a complete, ranked list of

priorities for rulemaking, including justification for the ranking.

NIOSH specifically sought comments on the following issues for module

development ranking: changes needed to current respirator certification

requirements in the modules identified in the notice, subject areas for

improving current certification requirements not identified in the

notice, suggested module rankings, with ranking criteria and data or

reasoning, industries and workers affected by potential changes,

technical feasibility of suggested changes, economic impact to

respirator manufacturers, purchasers, and users, and other factors

related to the priority ranking.

A. Discussion of Comments Received

NIOSH has developed a ranked list of priorities for rulemaking,

including justification for the ranking based on the comments received.

Areas recommended for modification by commenters were grouped into

feasible modules, then ranked according to the priority ranking

criteria. The ranking justifications, based on the available supporting

information, are included with the listing of the identified modules in

IV.B. Conclusions.

The purpose of this notice is to inform the respirator community of

regulatory priorities to allow research and planning to be coordinated

with the development of new standards. NIOSH research and development

efforts will be directed primarily at the highest priority areas

identified in this notice. NIOSH also encourages others in the

respirator community to conduct research in the identified module

areas.

Research results and planning information for the regulatory

priorities identified in this notice should be submitted to the NIOSH

docket when they become available. The information will then be in a

forum for public

[[Page 54000]]

review and comment. The information received in the NIOSH docket will

establish a database to help develop future regulatory proposals.

Most of the determinants in the ranking criteria are based up the

agency's current understanding of the capabilities of the manufacturing

community as well as the science upon which the product development is

based. Chief among these is the expediency by which a change can be

implemented. NIOSH has attempted to estimate the research needed for

each identified module in this priority-ranking process. It must be

recognized that module development will be based on the successful

completion of research in most of the identified module areas.

Therefore, the rulemaking order of the identified modules may vary

slightly from the priority order identified in this notice.

B. Conclusions

The following module list identifies the priority assessment for

development of technical improvements based on the information provided

by commenters:

1. Powered Air Purifying Respirator (PAPR)

Areas for potential modification in this module are: Establishment

of N, R, and P series filters; Use of active low flow or low pressure

warning devices; and Addition of new duration ratings.

The regulations require the PAPR battery to have a service time

sufficient to maintain a stated air flow throughout 4 hours of

operation during a silica dust loading test with particulate filters.

One commenter stated that the current requirements result in units

that are too heavy and burdensome for most applications. Another

commenter specifically suggested that modifications should be made to

allow a light weight hood type PAPR for the health-care industry.

One commenter recommended the requirement of low flow and negative

pressure warning devices to assure workers are protected from

overbreathing the PAPR air supply. This commenter also recommended the

establishment of a pressure demand PAPR. Two other commenters suggested

the use of these devices and breathing-assist devices to establish

positive pressure and negative pressure classes of PAPR's. These

commenters indicated that PAPR duration may be able to be defined by an

active alarm from a low pressure or low flow sensor, signaling an end

of the battery's service life.

Presently, the filter choices for use with PAPR's has been limited

to only high efficiency particulate air (HEPA) filters with the

implementation of part 84. Commenters indicated that additional choices

are necessary.

Four commenters stated that the regulations should be modified to

include the same filter classes for PAPR's as are provided for non-

powered filter respirators under 42 CFR 84. PAPR filter testing was

included in the proposed 42 CFR 84 (59 FR 26850), but was not included

in the final rule because additional research is needed to make the

proposed tests more feasible and consistent with the part 84 filter

tests.

Seven commenters indicated that PAPR requirements should be the top

priority for technical revision of the regulations. The possibility of

increased worker protection with lighter, cheaper units was represented

by most of these commenters.

Estimates of more than 500,000 PAPR users in chemical, health care,

pharmaceutical, agriculture and welding were provided by a commenter.

2. Airline Respirator

Areas for potential modification in this module are: Single airline

for pneumatic devices and breathing air; Airline suits (i.e.,

Department of Energy/Los Alamos National Laboratory suits); Metabolic

simulator tests; Air flow/pressure rate requirements; and Air flow

measuring and warning devices.

Presently, 42 CFR part 84 does not contain a respirator

classification that allows a single airline to the person for pneumatic

devices and breathing air. NIOSH has recommended against this practice

due to concerns over potential contamination of the air supply, and the

high potential for negative impacts on respirator performance. In the

absence of a dedicated breathing-air system, there is an increased risk

of a contaminated air supply and negative impacts on respirator

performance due to: backflow of contaminants from the pneumatic device

line to the respirator air supply, low air flow and pressure to the

respirator from a severed pneumatic-tool line, and excessive air flow

and pressure from a blocked pneumatic-tool line.

Four commenters asserted that the breathing air could be filtered

to Grade D specifications at the person wearing the respirator (e.g. on

the belt). They stated that technology is available to ensure that an

air filtering system incorporated into a respirator design would

provide Grade D breathing air at the wearer, and this design should be

certified by NIOSH. One of the commenters indicated that by providing

safeguards against robbing air from the respirator, or feedback from

pneumatic tools, a criteria could be developed for supplied air

respirators (SAR) that allow a single airline for tools and breathing

air. The use of air flow or pressure devices were suggested to provide

needed assurances and warning of appropriate user air supply. Three of

the commenters indicated that appropriate European standards that NIOSH

could adopt exist for such a respirator class.

Presently, there is a standardized set of exercises and work rate

criteria used in the evaluation of SAR's. The use of a metabolic

simulator for testing was recommended by two commenters to help

eliminate the variability associated with human testing. According to

several commenters, the criteria for certifying SAR's could be upgraded

by modifying the class criteria to reflect differing work rates with

minimum flow rates and pressure differential from atmosphere. This

would result in new, additional classifications for SAR's. One

commenter recommended the use of air flow volume measuring and low flow

warning devices. Three commenters suggested that a positive pressure

class be defined. Another commenter suggested that a positive pressure

within the facepiece should be required at the tested work rate.

Two commenters stated that a criteria is needed for NIOSH-

acceptance of airline suits for respiratory protection. These

commenters asserted that airline suits (i.e., Department of Energy/Los

Alamos National Laboratory suits) have been used for respiratory

protection against hazardous and toxic substances for twenty years

under a Department of Energy acceptance program. In addition to

respiratory protection, one of the commenters stated that the suits

provide benefits such as total body protection and relief of heat

stress. A Los Alamos National Laboratory evaluation protocol (LA-10156-

MS) was recommended for as an acceptable criteria by both commenters.

Estimates of 50,000 auto body shops with over 100,000 workers, with

additional unnumbered workers in other industries were given by one

commenter as potential users of single airline respirators.

Several commenters stated that workers were improperly protected

because the NIOSH-certified supplied air respirators were not conducive

to use because they require two airlines to separate pneumatic device

air from breathing air. Estimates were given that less than 5% of U.S.,

more than 95% of British, and more than 90% of European auto painters

use proper respirators. Cost savings and greater user acceptance were

projected based on the possible

[[Page 54001]]

elimination of the installation and maintenance of a second airline.

3. Self Contained Breathing Apparatus (SCBA)

Areas for potential change in this module are: maximum weight

limit, with accessory definition; Upgrade of cylinder air

specifications; Incorporation of NFPA requirements; Non-facepiece SCBA;

Metabolic simulator tests; Air flow/pressure rate requirements.

Presently, 42 CFR part 84 limits the weight of a completely

assembled and fully charged SCBA apparatus to 35 pounds for most units.

A maximum weight of 40 pounds is allowed only where the weight

decreases by more than 25 percent of its initial charge weight during

its rated service life or where an apparatus employs a cooling system.

NIOSH does not include the weight of accessories in the total weight of

a respirator.

Four commenters suggested that the maximum weight limit of an SCBA

apparatus should be permitted to exceed 35 pounds where other fire

fighter protective clothing or equipment is incorporated with the SCBA.

One of them recommended a definition for accessories is needed to

better define those items not included in the weight calculation. These

commenters stated that this change could result in more comfort,

greater protection, and a lower overall ensemble weight for fire

fighters.

Presently, there is a standardized set of exercises and work rate

criteria used in the evaluation of air supplied respirators. According

to several commenters, the criteria for certifying SCBA's could be

upgraded by modifying the class criteria to reflect differing work

rates with minimum flow rates and pressure differential from

atmosphere. This would result in new, additional classifications

specifically for SCBA's. One commenter recommended the use of air flow

volume measuring and low flow warning devices. Three commenters

suggested that a positive pressure class be defined. Another commenter

suggested that a positive pressure within the facepiece should be

required at the tested work rate. One commenter suggested that the

requirements for open circuit apparatus should be separated from the

requirements for closed circuit apparatus.

The use of a metabolic simulator for testing was recommended by two

commenters to help eliminate the variability associated with human

testing.

Incorporation of standards consistent with life support efficacy

portions of the NFPA requirements were recommended to upgrade the

current standards. Three commenters stated that some NFPA 1981-1992

requirements should be included in the NIOSH requirements. Higher air

flow rates and lens abrasion resistance were provided as examples. One

of these commenters recommended the incorporation of NFPA 1981-1992 for

fire fighter SCBA, with some of the requirements applicable to all

SCBA. This commenter also stated that the dew point and particulate

level requirements of NFPA 1500-1992 should be required for SCBA

cylinder air.

One commenter requested provisions be developed for NIOSH to

approve SCBA without a facepiece. This commenter asserted that the

National Aeronautics and Space Administration (NASA) has used non-

facepiece, suit SCBA since the early 1960's without any serious

problems. This commenter stated that similar suits are being developed

for decontamination and decommissioning of Department of Energy sites

and other chemical waste sites. The commenter recommended a revision to

the regulations to allow NIOSH certification of this class of

respirator.

One commenter suggested that NIOSH should accept alternatives to

Department of Transportation (DOT) and Compressed Gas Association (CGA)

cylinder requirements. This commenter asserted that a cylinder could be

incorporated as an integral part of the SCBA design without a

standardized CGA cylinder thread, which is design restrictive. The

commenter also recommended that cylinder acceptances of other

certifying agencies throughout the world be recognized as equivalent to

the United State's DOT requirements. No user population size or overall

user type estimates were provided by commenters for SCBA. However,

NIOSH is aware of estimates of the number of fire fighters in the U.S.

While not representing users of all SCBA, fire fighters are believed to

be a significant portion of the SCBA user population.

According to the National Fire Protection Association's (NFPA) 1995

Fire Department Profile, there are 1,098,850 fire fighters (260,850

career and 838,000 volunteer) in the United States. According to the

National Volunteer Fire Council, a non-profit membership association

representing the interests of the volunteer fire, emergency medical,

and rescue services, there are 1.5 million volunteer firefighters who

staff more than 28,000 fire departments throughout the United States.

The International Association of Fire Fighters (IAFF) represents over

225,000 professional fire fighters and emergency medical personnel in

the United States and Canada. In 1992, NIOSH estimated 400,000

firefighter SCBA's were in use by some 200,000 full time and 1,000,000

volunteer and non-municipal firefighters in the U.S.

4. Gas and Vapor Respirator

Areas for potential modification in this module are: Certification

to a wider variety of specific substances and addition of service life

categories.

Presently, NIOSH certifies gas and vapor (chemical cartridges

included) respirators only to provide protection against only sixteen

specific substances. Gas mask canisters and chemical cartridges may be

classified for protection against the general category of organic

vapors. Gas mask canisters may also be classified for protection

against the general category of acid gases. Their use against

substances with poor warning properties has not been recommended.

One commenter stated that there is a need for a new class of

respirators for protection against the accidental release or

terroristic use of chemical agents. This commenter asserted that local

law enforcement, first response teams, and local and state agencies are

seeking and need NIOSH-certified respirators in responding to these

events. The use of existing facilities that test and evaluate equipment

against chemical warfare agents for the military was proposed as an

alternative to new NIOSH facilities.

The current standards in 42 CFR 84 provide for a canister or

cartridge absorption capacity test criteria based on the respirator

type. Two commenters indicated that NIOSH-certified canisters and

cartridges are heavy and bulky because of too severe service life

requirements. They asserted that various service times (or sorbent

capacities) could be appropriately used, based on the conditions of

use. They recommended modifying the certification standards to include

other service time possibilities and absorption capacities under

additional test parameters. One of these commenters recommended the

regulations be modified to allow for certification of three cartridge

capacity sizes by using three challenge levels of exposure for

certification, similar to the European standards.

No precise user population estimates were cited by commenters.

Users were identified only as unnumbered workers such as law

enforcement personnel and first response teams with accidental release

of chemical agents and chemical warfare agents.

[[Page 54002]]

V. Notification of Revised Priority Assessment

A. Comment Request

NIOSH will readily notify respirator manufacturers directly about

changes to the regulatory priorities established in this notice. NIOSH

specifically sought comments on how respirator purchasers and users

should be notified of revised priorities.

B. Discussion of Results

Commenters suggested various mechanisms for notifying respirator

purchasers and users of revised priorities. One commenter suggested the

use of a Respirator Users' Notice. Three commenters suggested the use

of the NIOSH internet Web site. Three commenters recommended the

information be published in safety industry newspapers, magazines, and

newsletters like the BNA ``Occupational Safety and Health Reporter''.

Two commenters suggested the use of another Federal Register notice.

One commenter each suggested that the respirator manufacturers, sales

and marketing managers, and major users groups like the American

Industrial Hygiene Association (AIHA), Chemical Manufacturers

Association (CMA), National Association of Manufacturers (NAM), and

American Iron and Steel Institute (AISI) be used to notify respirator

purchasers and users.

C. Conclusions

NIOSH has established the priorities for rulemaking based on the

comments received to the May 16, 1996 request. However, these

priorities may change as new needs are identified or unforeseen delays

are encountered with research efforts. New modules may be needed to

respond to emerging hazards and developing technology.

Commenters failed to reveal any new mechanisms for NIOSH use to

better disseminate rulemaking priority updates. NIOSH has used

respirator-related mailing lists (including the Users Notice List and

Respirator Manufacturers List), the NIOSH internet Web site, the

Government Printing Office electronic bulletin board, press releases,

and the NIOSH toll-free information number to disseminate Federal

Register notices.

Publication of the information in safety industry newspapers,

magazines, and newsletters is dependent on the publishers' expectations

of reader interest. Dissemination of the information by the respirator

manufacturers, sales and marketing managers, and major users groups

depends on their willingness and ability to relay the information to

their clientele. NIOSH respirator-related mailing lists have

historically been generated as a result of public comments or a request

for respirator-related publications. World-Wide Web and electronic

bulletin board listings rely on the reader to go to the site to find

the information.

NIOSH will continue to disseminate Federal Register notices as in

the past, while continuing to seek better notification methods.

VI. Administrative and Quality Assurance Issues

A. Private Sector Testing Laboratories

Specifically, NIOSH sought comments on the following issues for the

potential use of private sector testing laboratories for the

certification process:

Capability of private sector testing laboratories to

conduct the respirator testing currently performed by NIOSH.

Qualification requirements of private laboratories if they

were to perform certification and product audit testing under NIOSH

guidance.

Assignment of a manufacturer's respirators to testing

laboratories by NIOSH or manufacturer choice among approved

laboratories.

Monitoring of private sector laboratories to assure

quality service would be continued if they were to perform

certification and product audit testing under NIOSH guidance.

1. Discussion of Comments Received

Many of the commenters endorsed, with reservation, the idea of

empowering private sector testing laboratories to conduct the NIOSH

certification testing. Concerns about NIOSH's ability to empower these

laboratories were raised by most of the commenters. These concerns

centered around (1) the existence of lab capability in the private

sector, (2) impartiality and credibility of testing and (3)

documentation of the NIOSH testing procedures and reproducibility of

results.

Five commenters questioned the existence of testing laboratory

capability in the private sector. Nine commenters supported the belief

that private sector testing laboratories are capable of performing the

NIOSH testing. Several of these commenters indicated that the testing

ability and capacity currently exists with certification of self

contained breathing apparatus to NFPA requirements. They further stated

that added capacity would be quickly obtained for other respirators

once the market was there.

Five commenters stated that the documentation of the NIOSH testing

procedures need to be improved before other testing authorities should

be authorized to conduct the certification testing. These commenters

expressed concern that test results would not be reproducible among a

number of testing facilities. That is, test results could vary from

laboratory to laboratory without an inter-laboratory validation

program.

Concerns were raised by several commenters that impartiality and

credibility would be lost with the testing portion of the certification

process removed from NIOSH control. One commenter was concerned that

any laboratory not have any vested interest in the certification of

products or with manufacturers. A few commenters indicated increased

NIOSH staff would be more productive than using private sector

laboratories. These commenters felt that NIOSH resources would be

consumed with oversight of accredited laboratories.

Another commenter stated that the survivability of private sector

testing laboratories depends on their ability to demonstrate

impartiality and credibility in their test results. Several other

commenters indicated that use of already established accreditation or

certification programs would require little or no additional NIOSH

oversight.

Four commenters indicated that the European experience with

privatization and U.S. certification authorities such as the NFPA and

Safety Equipment Institute (SEI) have been good. Experiences with

favorable turnaround times and costs were reported.

Commenters recommended that NIOSH adopt an existing system, rather

than create a new one. Three commenters recommended accreditation by

the American National Standards Institute (ANSI) to ANSI Z34.1. This

standard was judged inappropriate for lab privatization by another

because it is a complete program that includes design, QA and product

testing requirements for the certification of manufacturers' products

by the authorized entity. This is similar to the current NIOSH process.

ISO Guide 25, a tool to assess and accept a laboratory's calibration

and QA procedures for accurate and consistent results, was recommended

by four commenters. Two more commenters suggested that NIOSH should

become ISO certified as well.

2. Conclusions

NIOSH agrees with those commenters who stated that the use of

private sector testing laboratories could expedite the approval process

and the availability of the latest and safest technology. This will be

accomplished only if the use of

[[Page 54003]]

these laboratories increases the resources available to conduct the

tests. NIOSH shares the concern expressed by some commenters that an

insufficient business base may exist to assure the increased resources,

quality level and cost would be acceptable.

Private sector testing laboratories can be utilized in the

certification of respirators, provided that adequate procedures and

safeguards are in place. No existing testing laboratory accreditation

or certification programs have standards and procedures that accredit

or certify laboratories to perform the NIOSH tests. The procedures and

standards to accredit or certify testing laboratories to conduct the

NIOSH tests need to be developed before a laboratory could be

accredited. Clear, objective test requirements and protocols that

provide test results reproducible between laboratories also need to be

finalized and made available before most NIOSH tests can be used by

private testing laboratories.

NIOSH has determined that there are private sector testing

laboratories with the capability to perform the NIOSH tests. However,

NIOSH is concerned that there is insufficient testing capacity to meet

the demand for testing. NIOSH has seen no evidence that this capacity

is present, especially considering the comments that refined procedures

are needed to allow others to conduct the NIOSH tests. Efforts to

develop testing laboratory certification and auditing criteria will

consume some NIOSH resources to establish the program.

NIOSH is continuing to explore options for the potential use of

private sector testing laboratories for the certification process.

However, the infrastructure to define and support the use of these

laboratories remains to be established. NIOSH intends to propose an

Administrative module to address the use of private sector testing

laboratories for the certification process after the infrastructure

needs are better determined.

B. Private Sector Quality Auditors

Specifically, NIOSH sought comments on the following issues for the

potential use of private sector quality auditors for the certification

process:

Qualification requirements (e.g., certification by ANSI-

Registrar Accreditation Board, United Kingdom Accreditation Service,

International Auditor and Training Certification Association, etc.) of

independent quality auditors if they were to perform manufacturing site

audits under NIOSH guidance.

Assurances of integrity for a program using private

quality auditors.

Frequency of audits needed to assure that only quality

products are distributed.

Auditing of manufacturing sites prior to the issuance of a

NIOSH certification.

1. Discussion of Comments Received

No commenters opposed the use of private sector quality auditors

for the certification process. Three commenters endorsed the use of the

International Organization of Standardization certification standards

(ISO) for evaluation of the manufacturers' quality assurance systems.

Two of these commenters pointed out that, specifically, ISO 9001 should

be adopted because it documents the design and development process,

unlike ISO-9002.

The ISO standards were perceived by several commenters as

sufficient to ensure the integrity of the program. One commenter stated

that the ISO system requires auditors to be certified by authorities

such as Underwriters Laboratories. A commenter stated that NIOSH must

develop the criteria for an acceptable quality assurance plan for use

by an ISO auditor. Two commenters believed that ISO 9001 audits could

be used instead of NIOSH audits because the ISO audit would ensure the

quality assurance plan is met. These same commenters thought that the

ISO semiannual or annual frequency of audit was appropriate.

Two commenters pointed out that ISO 9000 requires site audits prior

to registration. Therefore, if a manufacturer has been ISO-certified,

they stated no NIOSH pre-certification audit would be needed. If the

manufacturer has not been ISO-certified or is a new manufacturer, they

stated that a NIOSH pre-certification audit would be appropriate.

2. Conclusions

Qualified quality auditors may be used to perform site audits for

verification that the manufacturers' quality systems are being followed

and are appropriate. Empowering qualified auditors would expand the

audit portion of the certification program to levels consistent with

most contemporary certification authority requirements. NIOSH has been

developing audit guidelines that could enable a qualified auditor to

evaluate compliance with the salient points of a manufacturer's quality

assurance plan.

NIOSH is evaluating the appropriateness of the ISO 9000 series

standards with NIOSH-added requirements specific to respirators, or

equivalent, to evaluate a manufacturer's quality system. NIOSH is also

considering requirements for certification of auditors, and the

oversight needed to ensure that audit quality is comparable to that

which has been provided by NIOSH employees. Audits conducted by

independent auditors would be used to complement NIOSH audits. The

requirement for a pre-certification audit is also under evaluation.

NIOSH intends to address the use of private sector quality auditors for

the certification process in an Administrative/Quality Assurance module

to be proposed in the near future.

C. Fee Schedule

Specifically, NIOSH sought comments on the following issues for

updating the fee schedule to reflect the actual costs to maintain the

program:

Certification fee structure and calculation to recoup the

cost of the certification process.

NIOSH fee collection for manufacturing site and product

audits.

NIOSH fee collection for respirator complaint

investigations.

1. Discussion of Comments Received

Eight commenters supported fair fee charges that accurately reflect

the services received. These commenters stated that fees should be fair

and equitable to NIOSH and the manufacturers. One of these commenters

noted that excessive fees would be a deterrent to improving products,

while another stated a willingness to pay more for faster approval. Two

commenters recommended that collected fees be retained in the

certification program to make it self-sustaining.

Five commenters did not think that NIOSH should recoup all costs of

the program. One of these commenters felt there should not be charges

for site and product audits. The other four argued against fees for

product complaint investigations. One of them suggested there could be

challenge procedures where the loser pays the investigative costs for a

complaint. Another stated that the manufacturer should not be

responsible for most complaints, because they are minor or frivolous.

Another commenter believed that fees would be unfair because the

manufacturer may not necessarily be at fault. The fifth commenter felt

that NIOSH should bear the cost of complaint investigations because

they are a NIOSH responsibility. Three of these commenters did

indicate, however, that a fee may be appropriate if the basis for the

complaint is

[[Page 54004]]

determined to be the manufacturer's fault.

Five commenters specifically endorsed a NIOSH fee to recoup the

total cost for audits. One of these commenters stated that this would

not be an additional expense for NIOSH or ISO-certified manufacturers

if NIOSH accepted the results of ISO audits. Conversely, this commenter

believed that NIOSH should conduct audits and charge fees to recoup

their cost for manufacturers not ISO-certified. Another of these

commenters suggested that the original fees that NIOSH charges for

issuing a certification should include the costs of site and product

audits.

One commenter stated that the fees should relate to all the tasks

performed in the certification process. Another stated that the fee

structure should include fees for each discrete, identifiable part of

the process. A third commenter supported flat fees as the preferred fee

structure. This commenter also stated that NIOSH should charge an

hourly rate based on staff time and supply costs if flat rates can't be

calculated. Two commenters suggested an annual maintenance fee based on

the number of units produced or sales. One of these commenters further

stated that an annual fee should be collected per model.

Two commenters suggested that fees should be reviewed and

recalculated annually. Another commenter stated that the fees should be

computed based on actual costs, and published for comment.

Several commenters recommended that collected fees be retained in

the certification program to make it self-sustaining.

One commenter requested the establishment of fee accounts for

withdrawal of fees when due.

2. Conclusions

The fees and fee structure for activities conducted in the

certification program are currently based on the fee schedule contained

in 42 CFR part 84. This fee schedule has not been updated since 1972.

The costs of conducting a certification program have risen over the

years, but these increased costs have not been reflected in

certification charges. The fees charged for NIOSH services do not

recover the costs to maintain the program.

NIOSH intends to update the current fee structure to offset the

expenses and administrative costs of the program. NIOSH intends to

update the current fee structure in an Administrative/Quality Assurance

module to be proposed in the near future. For future updates in the

fees, NIOSH may consider other fee structures to better cover the

program costs.

D. Component Part Certification

Specifically, NIOSH sought comments on the following issues for

evaluation and certification of respirator component parts:

Authorization of manufacturers other than the original

respirator manufacturer for replacement parts.

Effectiveness of replacement parts, if alternate suppliers

for replacement parts were allowed.

Component-specific requirements of replacement parts, if

alternate suppliers for replacement parts were allowed.

Certification of respirator components in addition to, or

instead of, complete respirators.

Other certifying agencies or standards organizations that

allow suppliers other than the original manufacturer to provide

replacement parts for certified units.

Monitoring of alternate suppliers, if suppliers other than

the original manufacturer were permitted to provide replacement parts.

Monitoring of replacement parts, if suppliers other than

the original manufacturer were permitted to provide them.

Interchangeability of parts by design specifications, if

alternate suppliers for replacement parts were allowed.

1. Discussion of Comments Received

Three commenters endorsed the concept of component certification

for the manufacture and sale of replacement parts by persons other than

the respirator manufacturer. Two of these commenters stated that other

standards or certifying organizations, including NFPA, allow third

party replacement parts. One commenter stated that lower prices for

respirators and disposable parts would result from standards that

facilitate interchangeability of some parts. Two commenters stated that

the replacement parts should be certified just as complete respirators,

documenting equivalent form, fit and function of the original

respirator. Component-specific requirements should be able to be

covered in the general certification scheme, according to one

commenter.

Most commenters did not favor the concept of component

certification for the manufacture and sale of replacement parts by

persons other than the respirator manufacturer. Nine commenters

objected to allowing replacement parts from a manufacturer other than

the respirator's original manufacturer. Respirator design restrictions

to allow interchangeability of parts, copyright infringements and

liability concerns were expressed as reasons for opposition.

Two commenters indicated that replacement parts by others should be

permitted only if the manufacturer is in agreement. Four commenters

voiced concerns of product liability of replacement parts by others.

One commenter stated that the acceptable use of third party parts would

encourage copyright infringements.

Six commenters believed there would be no way to verify original

specifications are met with other manufacturers' parts. Therefore, they

asserted, the certification program could not assure respirator system

performance. Two commenters supported certification of complete

respirators only. Two commenters stated that other standards, including

SEI certification, Japanese, Korean, and Australian loosely-EN-based

standards do not allow interchangeability of components.

Four commenters pointed out that interchangeability in Europe is

allowed only for certain components. Two of these commenters asserted

that the conformity required for interchangeability in Europe creates

design restrictions. One commenter believed that developing component-

based requirements would be horrendous. Another commenter reported the

European experience to be that users don't utilize the option to obtain

replacement parts from third parties. One commenter pointed to

significant administrative expenses with testing and certification of

replacement parts as another rationale for not adopting this concept.

Five commenters stated that NIOSH would need to monitor third party

parts and suppliers the same as respirator manufacturers. Three

commenters stated that allowing replacement parts by other than the

respirator manufacturer would require testing to assure overall

compliance of assembled respirator.

Some of the commenters opposing the concept recognized potential

cost and program savings if a limited component certification program

were developed. Three suggestions were made for components to be

certified for use within the assembly of a single manufacturer's

components, to make a complete respirator by the assembly of certified

components. The certification for interchangeability of air lines and

some air-supplied respirator parts were

[[Page 54005]]

also suggested as viable program options by two commenters.

2. Conclusions

The certification standards limit NIOSH to certify only complete

respirators. Component parts are not evaluated independently. Any

component part, or replacement part, certification program would

require the development of component-specific requirements that ensure

that the respirator continues to perform effectively.

No commenters raised safety or health concerns to support

development of a component parts certification program. Only economic

benefits were provided as reasons for support. Commenters raised

seemingly valid safety and health, legal and technical concerns

opposing component parts certification. Based on the comments received,

NIOSH is not developing a component certification program at this time.

E. Product Auditing

Specifically, NIOSH sought comments on the following issues for

product auditing of respirators:

The maximum number of respirators per year, aside from

problem investigations, that NIOSH should request from a manufacturer,

at no charge to NIOSH.

Acquisition of products for audit (i.e., by voucher,

reimbursement, random selection by NIOSH at the manufacturer or

distributor).

Reimbursement of NIOSH costs for product audits.

1. Discussion of Comments Received

One commenter stated that there should be no charge for conducting

product audits. This commenter stated that auditing costs should be

included in the cost of government enforcement activities. Another

commenter believed that, with the resources available to the

government, the government should pay for all products it acquires.

Five commenters indicated that fees should relate to the task, and that

the total cost for any audit should be charged. One of these commenters

thought that the original fees for a certification should include costs

of site and product audits.

One commenter suggested that products for audit should be selected

from the manufacturer's warehouse during site audits, as is done in

other programs. A second commenter recommended a voucher system be used

to acquire audit samples from distributors. This commenter stated that

it was important that the manufacturer not be allowed to pre-screen

audit samples to assure compliance.

2. Conclusions

NIOSH has historically purchased product audit samples from

distributors. Although NIOSH occasionally requests audit samples from

the manufacturer's inventory during site audits, products for audit are

predominately purchased with appropriated funds. This severely limits

the number and type of products that can be audited each year.

NIOSH is considering options to obtain appropriate numbers of

product audit samples from manufacturers at no cost to NIOSH. NIOSH

intends to address the acquisition of product audit samples in an

Administrative/Quality Assurance module to be proposed in the near

future.

F. Approval Duration

Specifically, NIOSH sought comments on the following issues for

limiting the time duration or number of units for which a respirator

certification would be valid:

Time limits for the NIOSH certification to be valid.

Conditions for renewing a NIOSH certification, if it were

time-limited.

Recommended time limits for a NIOSH certification and

renewal, if it were time-limited.

Notification requirements for changes in production status

and the number of produced units when production is halted.

Affect on purchasers and users if the certification of

their respirator expires.

Benefits to purchasers and users of an expired

certification.

Benefits to purchasers and users of knowing the number of

respirators produced under a certification.

1. Discussion of Comments Received

Generally, comments were divided on the issue of time limits on an

approval. Five commenters opposed time limits, while four commenters

endorsed the concept.

Suggestions for a renewal process varied. One commenter suggested

that annual renewal should be required. Another commenter pointed out

that the National Fire Protection Association's standard for

firefighter SCBA certification (NFPA 1981) requires recertification

every 5 years. Yet another commenter stated that product approvals of

this type are generally required to be requalified after a one to five

year period. One commenter believed that a complete resubmittal from

the manufacturer of the product should be required 9 years after

certification, or the authority to manufacture and sell the product as

NIOSH-certified would expire in the tenth year.

Commenters opposed to time or quantity limitations contended that

certification expirations would cause undue user confusion and be

overly burdensome on the manufacturers, and users would not benefit in

knowing the population of specific models. One commenter pointed out

that similar European requirements resulted in increased cost and

obstructed sales. Several commenters also believed that production and

sales levels are confidential to the manufacturer. Other commenters

contended that such limitations were not needed because the evolution

of products through technological advancements and approval schedule

updates will limit the age of approvals that can remain active.

Three commenters suggested that NIOSH could require production

change reports from the respirator manufacturers. A fourth commenter

suggested that NIOSH could check the production status of approved

respirators in conjunction with annual quality audits. Two commenters

recommended that approvals be classified as Active, Inactive or

Obsolete based on their production status. One of these commenters

suggested inclusion of the production status in the NIOSH Certified

Equipment List (CEL). Yet another commenter stated that users would be

notified of an approval's expiration by removal from the equipment

list.

2. Conclusions

NIOSH agrees with commenters who asserted that user notification of

the status of NIOSH-certified respirators is important. NIOSH also

agrees with commenters who believed that time or quantity limitations

on certifications could create an added burden on manufacturers and

NIOSH by creating added applications for recertification of products.

NIOSH is aware that manufacturers generally sell components

individually that can be used in configurations covered under a number

of certifications. Therefore, potentially little data exists to

represent the number of respirators sold or in use under a specific

approved design.

NIOSH has concluded that it would not be appropriate or beneficial

to initiate time or quantity limitations on certifications at this

time. The purpose of user notification on certifications could be

served by receiving production status reports from respirator

manufacturers to indicate if the respirator is currently being produced

(active), no longer produced but units in

[[Page 54006]]

the field are supported with parts (inactive), or no longer in

production or supported with replacement parts (obsolete).

The status listing of Active, Inactive, or Obsolete status is

included in the NIOSH certified equipment list (CEL). In accordance

with received comments, NIOSH is requesting the manufacturers to

provide this production status information as soon as it becomes

available, to update the CEL. NIOSH intends to address the reporting of

production status information in an Administrative/Quality Assurance

module to be proposed in the near future.

VII. Priority of Quality Assurance/Administrative Modules

Based on the comments received, NIOSH intends to propose three

Administrative/Quality Assurance modules. The intended subjects for

these modules are:

A. Corrections and Existing Policies

1. Discussion of Comments Received

One commenter recommended that NIOSH publish technical amendments

to 42 CFR part 84 prior to any other modules. Specifically, this

commenter requested clarification of the 200 mg. filter loading levels

for particulate filters used in pairs.

One commenter suggested that air purifying respirators with end of

service life indicators (ESLI) should be certified for polyisocyanate

catalyzed paints. Several commenters stated that workers were

improperly protected because the adequate NIOSH-certified (supplied-

air) respirators were not conducive to use. Estimates of 50,000 auto

body shops with over 100,000 workers, with additional unnumbered

workers such as law enforcement personnel and first response teams with

accidental release of chemical agents and chemical warfare agents were

given.

Air-purifying respirators can be certified with ESLI's in

accordance with requirements published in the Federal Register on July

19, 1984 (49 FR 29270). That notice provided for the approval of air

purifying respirators with either effective passive or active ESLI for

use against gases and vapors with adequate warning properties or for

use against gases and vapors with inadequate warning properties

whenever there is a regulatory standard already permitting the use of

air purifying respirators.

Two commenters suggested a module to address self contained self

rescuers (SCSR) that are used in the mining industry. Both commenters

urged development of a duration testing protocol using a metabolic

simulator to replace human subject testing.

2. Conclusions

There are typographical errors in 42 CFR 84 to be corrected. There

are also a number of existing program policies that have been developed

since 1972 that are not included in the regulations. Policies affecting

areas such as ESLI for air purifying respirators and service life plans

for SCSR, need to be codified in the regulations as a single source for

the respirator approval requirements.

NIOSH will publish a module to make corrections and incorporate all

existing certification program policies into 42 CFR 84.

B. Upgrade of Quality Assurance Requirements and Fee Schedule

1. Discussion of Comments Received

As discussed previously in VI.B., no commenter opposed the use of

private sector quality auditors in the certification program.

Commenters also generally endorsed the use of ISO-9000 or similar

quality assurance requirements. NIOSH acceptance of audits conducted by

private sector auditors was also generally recommended by commenters.

As discussed previously in VI.C., the majority of commenters

supported fees that reflect the costs of the certification program.

As discussed previously in VI.F., a number of commenters supported

use of the NIOSH CEL to notify respirator users of the production

status of approved respirators.

2. Conclusions

NIOSH intends to publish a module to address the use of independent

quality auditors, respirator production status information and updated

fees.

C. Use of Independent Testing Laboratories in the Certification Program

and Restructured Fee Schedule

1. Discussion of Comments Received

As discussed previously in VI.A., a number of commenters expressed

reservations about the ability of NIOSH to use private sector testing

laboratories in the certification program. Several concerns, such as

the availability of test procedures and the accreditation method, were

presented.

As discussed previously in VI.C., some of the comments on fee

revision recommended substantial changes to the fees structure. These

recommendations included concepts such as: retention of the fees in the

certification program; annual maintenance fees; and fees for complaint

investigations.

2. Conclusions

NIOSH intends to publish a module to address the use of independent

testing laboratories and a restructured fee schedule.

VIII. Continued Comments

As stated previously, NIOSH is requesting additional comments and

information on content for the modules identified and prioritized in

this notice. Comments for the need to prioritize other module topics

are also welcomed. NIOSH will periodically review the information in

the docket to assist in determining if a priority reassessment is

needed. Comments should be mailed to the NIOSH Docket Office, Robert A.

Taft Laboratories, M/S C34, 4676 Columbia Parkway, Cincinnati, Ohio

45226, telephone (513) 533-8450, fax (513) 533-8285. Comments may also

be submitted by e-mail to: [email protected] E-mail attachments should be

formatted as WordPerfect 4.2, 5.0, 5.1/5.2, 6.0/6.1, or ASCII files.

Dated: October 8, 1997.

Linda Rosenstock,

Director, National Institute for Occupational Safety and Health

(NIOSH), Centers for Disease Control and Prevention (CDC).

[FR Doc. 97-27224 Filed 10-16-97; 8:45 am]

BILLING CODE 4163-19-P