24740 Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Proposed Rules

Dated: May 7, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. In § 180.1001 the tables in

paragraphs (c) and (e) are amended by

adding alphabetically the inert

ingredient, to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(c) * * *

Inert Ingredient Limits Uses

* * * * * * *

2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and

ethenyl acetate, number average molecular weight (in amu)

6,000 - 12,000.

Binding Agent

* * * * * * *

(e) * * *

Inert Ingredient Limits Uses

* * * * * * *

2-Propene-1-sulfonic acid, sodium salt, polymer with ethenol and

ethenyl acetate, number average molecular weight (in amu)

6,000 - 12,000.

Binding Agent

* * * * * * *

[FR Doc. 96–12195 Filed 5–15–96; 8:45 am]

BILLING CODE 6560–50–F

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:

DMM2@NIOSDT1.EM.CDC.GOV. 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
Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Proposed Rules 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 airpurifying 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
24742 Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Proposed Rules

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 precertification 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
Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Proposed Rules 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 tollfree 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

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 1

[GC Docket No. 96–101, FCC 96–192]

In the Matter of Implementation of

Section 34(a)(1) of the Public Utility

Holding Company Act of 1935, as

Added by the Telecommunications Act

of 1996

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: This notice of proposed

rulemaking (NPRM) seeks comment on

proposed regulations which implement

new section 34(a)(1) of the Public Utility

Holding Company Act of 1935

(PUHCA), as added by section 103 of the

Telecommunications Act of 1996. Under

new section 34, registered public utility