National Institute for Occupational Safety and Health (NIOSH); Meeting

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