[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]



=======================================================================
-----------------------------------------------------------------------

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.

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

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

[[Page 24743]]

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