[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
