[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Proposed Rules]
[Pages 53998-54006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27224]


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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