[Federal Register Volume 61, Number 96 (Thursday, May 16, 1996)]
[Proposed Rules]
[Pages 24740-24743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11859]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 84
National Institute for Occupational Safety and Health (NIOSH);
Meeting
AGENCY: National Institute for Occupational Safety and Health, CDC,
HHS.
ACTION: Public meetings and request for comments.
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SUMMARY: This document is to request public comments in preparation of
rulemaking to revise current NIOSH procedures for certifying
respiratory devices used to protect workers in hazardous environments.
NIOSH is seeking 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 will hold three public meetings in June 1996 to
discuss these issues and will consider all comments provided in
response to this notice.
DATES: The meetings are scheduled as follows:
1. June 6, 1996, 9:00 a.m. to 5:00 p.m., Washington, D.C.
2. June 7, 1996, 9:00 a.m. to 5:00 p.m., Washington, D.C.
3. June 8, 1996, 9:00 a.m. to 5:00 p.m., Northglenn, Colorado
ADDRESSES: The meetings will be held at the following locations:
1. Washington--Holiday Inn Capitol (Columbia Room), 550 C Street SW.,
Washington, DC 20024
2. Washington--Holiday Inn Capitol (Columbia Room), 550 C Street SW.,
Washington, DC 20024
[Open to the public, limited only by the space available.
The meeting room accomodates approximately 150 people.]
3. Northglenn--Holiday Inn Denver Northglenn (Pikes Peak Room), 10 East
120th Avenue, Northglenn, Colorado 80233
[Open to the public, limited only by the space available.
The meeting room accommodates approximately 200 people.]
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. Requests to participate in the public meeting should be mailed
to the NIOSH Docket Officer, at the same address.
FOR FURTHER INFORMATION CONTACT:
Richard W. Metzler or Roland Berry Ann, NIOSH, 1095 Willowdale Road,
Morgantown, West Virginia 26505-2888, telephone 304/285-5907.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Federal Mine Safety and Health Act of 1977 (Pub. L. 91-
173, as amended by Pub. L. 95-164), NIOSH and the Mine Safety and
Health Administration are mandated to approve respirators used for
worker protection. In June 1995, NIOSH published a final rule (42 CFR
part 84), beginning a stepwise or ``modular'' approach to updating the
respirator certification process and requirements. The 1995 final rule
transferred the existing standards for respirator certification from
the labor section to the health section of federal regulations to
expedite NIOSH rulemaking to improve these standards. Concurrently, the
final rule revised existing standards for certifying the most commonly
used respirators, air-purifying respirators used to filter out toxic
particulates. NIOSH had identified these revisions as
[[Page 24741]]
the highest priority for improving the protection of workers using
respirators.
II. Public Meetings
NIOSH will convene two public meetings to obtain comments from
interested parties on priorities for updating respirator certification
standards and other issues addressed in this notice.
The tentative agenda of the meetings includes a brief summary by
NIOSH of plans for rulemaking and a review of the issues outlined in
this notice. This will be followed by presentations by the public.
Participants will be given fifteen minutes to present comments.
Participants may comment on the issues addressed by this notice as well
as other concerns related to respirator certification.
Any interested person may, consistent with the orderly conduct of
the meeting, record or otherwise make a transcript of the meeting. Each
participant may submit relevant written information, data, or views for
inclusion in the record of the meeting. Any person who desires to
submit an advance written statement may file it with the NIOSH Docket
Office. A participant may be accompanied by a reasonable number of
additional persons, space permitting.
All interested persons are encouraged to submit written comments to
assure receipt on or before the close of business August 16, 1996, and
to advise the NIOSH Docket Office by close of business May 24, 1996, of
their intent to participate in the informal public meeting. All
requests to present at the informal public meeting should contain the
name, address, and telephone number, relevant business affiliations of
the presenter, a brief summary of the presentation, and the approximate
time requested for the presentation. NIOSH requests that oral
presentations be limited to 15 minutes.
After reviewing the requests for presentations, NIOSH will notify
each presenter by mail or telephone of the approximate time that their
oral presentation is scheduled to begin. If a participant is not
present when his or her presentation is scheduled to begin, the
remaining participants will be heard in order. At the conclusion of the
meeting, an attempt will be made to allow presentations by any
scheduled participants who missed their assigned times. Attendees who
wish to speak but did not submit a request for the opportunity to make
presentations may be given this opportunity at the conclusion of the
meeting, at the discretion of the presiding officer.
The record of the informal public meetings will consist of the
meeting schedule and any written comments submitted at the meetings or
in response to the meetings. The meetings will be video taped for the
record. In addition, an administrative record will be established
including a record of the informal public meetings and all comments
received in response to this notice. The administrative record will be
made available for viewing and copying in the NIOSH Docket Office. All
requests for any portion of the administrative record must be submitted
in writing.
III. Matters To Be Discussed
A. Priority of Technical Modules
1. Background
On May 24, 1994, NIOSH published a Notice of Proposed Rulemaking
(50 FR 26580) which led to promulgation of the current respirator
certification standards at 42 CFR Part 84. This proposal introduced the
modular approach to rulemaking NIOSH has adopted and listed anticipated
subjects and a sequence for future rulemaking. These subjects (in
proposed priority order) were: assigned protection factors,
administrative program (application submittal and processing, fee
structure, etc.), quality assurance requirements, gas and vapor
requirements (including maximum use concentrations), positive pressure
self contained breathing apparatus requirements, and simulated
workplace protection factor test. In response to that notice, NIOSH
received numerous suggestions for additional module subjects, such as
powered air-purifying respirators, smoke masks, fit testing, supplied
air respirators, gas masks, and combination respirators. Many
commenters also recommended a priority order for the sequence of
rulemaking. However, opinions on priorities were diverse and few
commenters included a rationale to support their suggested priorities.
None of the commenters indicated specific changes needed to improve
current standards. One commonality among suggestions was that they all
referred to the need to improve individual respirator classes (e.g.,
gas and vapor, powered air purifying, self contained, etc.). However,
component specific upgrades that are applicable across respirator
classes (e.g., head harness, facepiece, breathing hose, etc.) are also
possible in the modular approach.
2. Issues for Comment
Specifically, NIOSH is seeking comments on the following issues for
prioritizing the development of modules:
Issue 1. Diverse criteria may be considered to establish priorities
for improving respirator certification standards.
These include standard public health criteria such as the number of
persons (workers) affected, the seriousness of hazards or problems that
would be addressed, and the extent to which changes would improve
protection. Other criteria that also may have an important influence on
worker protection include, opportunity for cost savings (reducing costs
for manufacturers and purchasers of respirators) and the expediency by
which a change can be implemented (e.g., the existence of adoptable
consensus standards).
(1) What criteria should be used to rank the priority of each
module?
Issue 2. NIOSH will be developing a complete, ranked listing of
priorities for rulemaking, including justification for the ranking.
(1) In general terms, what changes to current respirator
certification requirements are needed in the modules identified in this
notice?
(2) Are there any subject areas for improving current certification
requirements that are not identified in this notice that should be
considered in the prioritizing process? If so, please include an
explanation of the importance of the subject and describe in general
terms the changes needed in current requirements.
(3) How should the modules be ranked, and why? Please provide
criteria and data or reasoning used to determine ranking.
(2) Are there existing national or international standards that
could be adopted by NIOSH to replace current certification requirements
pertaining to a given module? Please provide a rationale and indicate
any inadequacies of the suggested standard.
(3) How would potential changes to current requirements achieved
through a proposed module affect public health?
(4) Which industries and how many workers would be affected by
potential changes achieved through a proposed module?
(5) What would be the technical feasibility of suggested changes?
(6) What would be the economic impact to respirator manufacturers,
purchasers, and users resulting from the suggested changes?
(7) What other factors relate to the priority ranking of the
proposed module?
Issue 3. NIOSH will inform the respirator community of regulatory
priorities to allow research and planning to be coordinated with the
[[Page 24742]]
development of new standards. However, these priorities may change as
new needs are identified. NIOSH can readily notify respirator
manufacturers directly about these changes.
(1) How should NIOSH notify respirator purchasers and users of
revised priorities?
B. Administrative/Quality Assurance Module
1. Background
NIOSH certification requirements (42 CFR Part 84) contain
application procedures and technical requirements for respirators.
NIOSH currently tests and evaluates a product for a fee paid by the
applicant. Pretesting is required by the manufacturers. Drawings and
specifications submitted with the application are evaluated to ensure
that applicable technical requirements of 42 CFR Part 84 are met. This
includes evaluation of the manufacturer's quality control plan.
Manufacturers must assure that approved respirators continue to
conform to the specifications and design approved by NIOSH. Any
proposed change to the documentation must be submitted prior to
implementation of the change. If NIOSH approves the change, it issues
an extension of certification for the modified product. Manufacturers
are authorized to mark the product to identify its certification
status. The introduction of new performance standards for particulate
filters in the NIOSH certification requirements promulgated in June
1995 increased competition, caused the development of new technologies,
and resulted in new uses for respirators. All of these factors have
resulted in a dramatic increase in the volume of respirator
certification applications submitted to NIOSH. This increased volume of
application continues unabated eight months later and is overwhelming
NIOSH resources to process applications. The number of applications
awaiting processing (the working inventory), and the length of
processing time are both increasing, despite an accelerated rate of
processing.
All of the manufacturers who hold NIOSH certifications under Part
11 will apply for certification under Part 84. To date, approximately
one-third of these manufacturers have applied for certification under
Part 84. In addition, many manufacturers that have already received
certifications under Part 84 have informed NIOSH that their volume of
applications will continue at an increased level for the next 18 to 24
months. NIOSH anticipates similar increases in the volume of
applications with the promulgation of additional modules to improve
certification requirements.
The long-term prospect of high demand for processing applications
is leading NIOSH to investigate alternatives to expedite certification.
The current application process, which is largely based on practices
established in the early 1900's by the U.S. Bureau of Mines, cannot
expeditiously respond to the volume of applications associated with
periodic improvements to the standards.
In response to this situation, NIOSH is considering adopting new
administrative and quality assurance procedures that will enable the
Institute to use private sector resources. A primary concern in
investigating this option is safeguarding the integrity and public
credibility of the certification process. NIOSH may consider adopting
national and international standards (e.g., ISO-9000, Nationally
Recognized Testing Laboratories (NRTL), etc.) where feasible, to
provide oversight for the certification process.
2. Issues for Comment
Specifically, NIOSH is seeking comments on the following issues for
the development of this module:
Issue 1. Independent laboratories should be capable of performing
routine testing required for respirator certification. Transferring
this testing to private laboratories would enable NIOSH to focus on
aspects of the certification program other than pre-certification
evaluation. Newly available resources could be used for investigation
of complaints about certified respirators and development of testing
procedures and new standards for improving the certification standards.
However, NIOSH must ultimately be able to ensure the integrity of the
program.
(1) Are private sector testing laboratories capable of conducting
the respirator testing currently performed by NIOSH?
(2) What qualification requirements (e.g., certification by
National Voluntary Lab Accreditation Program (NVLAP), American National
Standards Institute (ANSI), NRTL, etc.) should NIOSH require of private
laboratories who perform certification and product audit testing under
NIOSH guidance?
(3) Should NIOSH assign the testing of a manufacturer's respirators
to laboratories approved by NIOSH or should the manufacturer be
permitted to use the laboratory of choice among approved laboratories?
(4) What type of monitoring should NIOSH perform to assure that
private sector laboratories continue to provide quality service?
Issue 2. Quality auditors with international certification are
authorized to conduct audits for International Organization of
Standardization (ISO) certification. The auditors could conduct audits
of manufacturers for NIOSH concurrently with audits required for ISO.
Combining these audits could result in fewer interruptions for the
manufacturer and lower inspector costs. NIOSH oversight of these
auditors can ensure that audit quality is comparable to that which has
been provided by NIOSH employees.
By primarily examining auditors, rather than manufacturing sites
and processes, NIOSH would be able to enhance worker protection. Use of
private sector quality auditors to perform routine manufacturing site
audits would allow manufacturing sites to be audited more frequently;
NIOSH audits each manufacturer on the average of once every four years,
while ISO audits are conducted twice a year. Use of ISO auditors would
also free up NIOSH resources to evaluate a potential certification
holder's quality control system prior to the production of any
certified respirators. This type of audit could be advantageous to both
the manufacturer and respirator users, reducing the potential for
manufacture and distribution of deficient respirators.
(1) What qualification requirements (e.g., certification by ANSI-
Registrar Accreditation Board, United Kingdom Accreditation Service,
International Auditor and Training Certification Association, etc.)
should NIOSH require for the acceptance of independent quality auditors
to perform manufacturing site audits under NIOSH guidance?
(2) What measures should NIOSH use to ensure the integrity of the
program using private quality auditors?
(3) What frequency of audits would be considered a minimum to
provide assurance that only quality products are distributed?
(4) Should manufacturing sites be audited prior to the issuance of
a NIOSH certification?
Issue 3. The fees and free structure for activities conducted in
the certification program are based on the fee schedule contained in 42
CFR Part 84. This fee schedule has not been updated since 1972, and
applies to only one of the five primary functions of the NIOSH
certification program. The fees are assessed only for pre-certification
technical evaluations and tests. The costs of conducting a
certification
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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 will
be updating the fee schedule to reflect the actual costs to maintain
the program.
(1) How should certification fees be structured and calculated to
recoup the cost of the certification process?
(2) Should manufacturers be required to pay for manufacturing site
and product audits?
(3) Should fees be collected by NIOSH for respirator complaint
investigations?
Issue 4. The certifications standards currently limit NIOSH to
certify only complete respirators. Standards are not provided to
evaluate component parts independently. There are not provisions in the
current addressing standardization and interchangeability of
components. Any change to a component part, or a replacement part that
differs from the original, can change the effectiveness of a
respirator, and decreased effectiveness normally cannot be detected by
the user. To ensure that respirators perform effectively, they must be
maintained as approved. Replacement parts are limited to those
specified in the certification for the manufacturer's assembly of the
respirator. These are the only components that have been evaluated for
effectiveness. As a result, a respirator user must obtain replacement
parts and service from the respirator's original manufacturer.
(1) Should NIOSH allow replacement parts for respirators by
manufacturers other than the original manufacturer of the respirator?
(2) How should the effectiveness of replacement parts be assured?
(3) Would NIOSH need to adopt or develop component-specific
certification requirements to allow alternate suppliers for replacement
parts?
(4) Should NIOSH consider certifying respirator components in
addition to, or instead of, complete respirator?
(5) Do other certifying agencies or standards organizations allow
suppliers other than the original manufacturer to provide replacement
parts for certified units?
(6) If suppliers other than the original manufacturer were
permitted to provide replacement parts, how should NIOSH monitor these
alternate suppliers?
(7) If suppliers other than the original manufacturer were
permitted to provide replacement parts, how should NIOSH monitor those
parts?
(8) Would NIOSH need to adopt design specifications to ensure that
interchangeability of parts is safe?
Issue 5. Products auditing is an ongoing NIOSH activity involving
the acquisition of respirators to assure compliance with NIOSH
certification requirements. These products are purchased from
distributors, inspected, and tested to verify they continue to meet the
NIOSH certification criteria. This activity provides a ``snapshot'' of
the results of quality control, quality assurance, and manufacturing
processes used to produce the certified respirator.
NIOSH currently procures approximately 64 respirators a year to
perform product audits. With increasing budget constraints and the very
small number of respirators that NIOSH can purchase each year, NIOSH
may require manufacturers to supply respirators upon request for
product audits.
(1) What would be the maximum number of respirator per year, aside
from problem investigations, that NIOSH should request from a
manufacturer, at no charge to NIOSH?
(2) How should NIOSH acquire products for audit (i.e., by voucher,
reimbursement, random selection by NIOSH at the manufacturer or
distributor)?
(3) Should manufacturer be charged for these product audits, since
they are a condition of certification?
Issue 6. The NIOSH certification is issued for an unlimited number
of units, without an expiration date. In the past, some certified
respirators have been removed from production for a period of time,
then returned to production. Some certification holders have even gone
out of business. There is currently no provision for notification to be
given to NIOSH of these events. Typically, NIOSH becomes aware of these
events only when attempting to purchase the affected respirator for
audit, or as a result of a field complaint. Consequently, NIOSH has no
information for most certified respirators on the number sold, or
whether or not they are still in production.
The NIOSH certification is only removed in the event a
certification rescission proceeding is invoked. Since 1919, only a
couple of rescission proceedings have occurred. These proceedings are
costly and time consuming to NIOSH, the manufacturers and users.
NIOSH is considering provisions that will inform the Institute on
the production of respirators under a certification. These provisions
could limit the time that a certification would be valid or require
notification of production status.
(1) Should the NIOSH certification be valid for a limited time?
(2) What conditions should be met for a time-limited NIOSH
certification to be renewable?
(3) What time limits should be used for a NIOSH certification and
renewal?
(4) Should certification holders be required to notify NIOSH of
changes in production status and the number of produced units when
production is halted?
(5) How would purchasers and users be affected if the certification
of their respirator expires?
(6) Would an expired certification benefit purchasers and users by
informing them that their respirator is no longer produced?
(7) Could information on the number of respirators produced under a
certification be used to benefit purchasers and users?
Availability and Access of Copies: Additional copies of this
document 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).
Dated: May 7, 1996.
Nancy C. Hirsch,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 96-11859 Filed 5-15-96; 8:45 am]
BILLING CODE 4160-19-M