53998 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

As a result, the specific legislative

authority in the submission is no longer

in effect. In addition to the above

changes, Texas’s technical and

equivalency method has not identified

and quantified accurately the covered

fleets in the Federal and State covered

areas. The Texas CFF program has

excluded certain covered fleets from its

total fleet aggregation in the El Paso and

Houston/Galveston nonattainment

areas. Without an adequate determined

fleet baseline for comparison, the SIP

revision’s technical evaluation is not

sufficiently comprehensive to determine

equivalency with the Federal CFF

program. These and additional concerns

with the State CFF program and broad

compliance exemptions lead EPA to

conclude that the State has not made a

convincing and compelling

demonstration of equivalency with the

Federal CFF program. A more detailed

discussion of the Texas CFF program

elements and control strategy can be

found in the Technical Support

Document available from the EPA

Region VI office.

III. Proposed Action

The EPA is proposing disapproval of

the Texas CFF SIP revision submitted to

EPA on August 6, 1996. The State’s

proposed substitute program is codified

in 30 Texas Administrative Code,

Chapter 114, Sections 114.30, 114.32

through 114.34, and 114.36 through

114.40. The EPA is soliciting public

comments on the proposed action

discussed in this notice. These

comments will be considered before

taking final action. Interested parties

may participate in the Federal

rulemaking procedure by submitting

written comments to the EPA Regional

office listed in the ADDRESSES section of

this notice.

The regional office, with EPA’s Office

of Mobile Sources has initiated efforts to

help ensure that this action is consistent

with the Act and will not interfere with

any applicable requirement concerning

attainment or any other applicable

requirement of the Act.

Nothing in this action should be

construed as permitting or allowing or

establishing a precedent for any future

request for revision to any SIP. Each

request for revision to the SIP will be

considered separately in light of specific

technical, economic, and environmental

factors and in relation to relevant

statutory and regulatory requirements.

IV. State Options

The following are options available to

Texas in the implementation of its CFF

Program. The State may choose to;

adopt the Federal CFF Program; or

revise the current Texas CFF program

and resubmit to EPA or substitute

another State program or control

strategy for the Texas CFF program.

Such a substitution could be a

stationary or mobile source control

program, but only if it consists

exclusively of provisions other than

those required under the Act.

V. Administrative Requirements

A. Executive Order (E.O.) 12866

The Office of Management and Budget

has exempted this regulatory action

from E.O. 12866 review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act,

5 U.S.C. 600 et seq., EPA must prepare

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities. See 5 U.S.C.

603 and 604. Alternatively, EPA may

certify that the rule will not have a

significant impact on a substantial

number of small entities. Small entities

include small businesses, small not-forprofit enterprises, and government

entities with jurisdiction over

populations of less than 50,000.

The EPA’s disapproval of the State

request under section 110 and

subchapter I, part D of the Act does not

affect any existing requirements

applicable to small entities. Any

preexisting Federal requirements remain

in place after this disapproval. Federal

disapproval of the State submittal does

not affect its State enforceability.

Moreover, EPA’s disapproval of the

submittal does not impose any new

Federal requirements. Therefore, EPA

certifies that this disapproval action

does not have a significant impact on a

substantial number of small entities

because it does not remove existing

requirements and impose any new

Federal requirements.

C. Unfunded Mandates

Under section 202 of the Unfunded

Mandates Reform Act of 1995, signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate or to private sectors, of $100

million or more. Under section 205,

EPA must select the most cost-effective

and least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires EPA

to establish a plan for informing and

advising any small governments that

may be significantly or uniquely

impacted by the rule.

The EPA has determined that the

disapproval action proposed does not

include a Federal mandate that may

result in estimated costs of $100 million

or more to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

imposes no new requirements.

Accordingly, no additional costs to

State, local, or tribal governments, or to

the private sector, result from this

action.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Carbon monoxide,

Hydrocarbons, Incorporation by

reference, Intergovernmental relations,

Nitrogen dioxide, Ozone, Reporting and

Recordkeeping requirements.

Dated: October 8, 1997.

Jerry Clifford,

Acting Regional Administrator.

[FR Doc. 97–27622 Filed 10–16–97; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention (CDC)

42 CFR Part 84

National Institute for Occupational

Safety and Health; Certification of

Respiratory Devices Used to Protect

Workers in Hazardous Environments

AGENCY: National Institute for

Occupational Safety and Health

(NIOSH), Centers for Disease Control

and Prevention (CDC), Department of

Health and Human Services (DHHS).

ACTION: Notice of priorities for

rulemaking.

SUMMARY: In response to public

comments received from its May 16,

1996, request (61 FR 24740), NIOSH is

announcing the intended priority order

for the development of the next

proposed rule amendments (modules) to

the current NIOSH procedures for

certifying respiratory devices used to

protect workers in hazardous

environments. The priority order is

based on the comments and data in the

public record. The priority order of the

planned modules is provided to help

the respirator community plan for

potential changes.

FOR FURTHER INFORMATION CONTACT:

Roland Berry Ann, NIOSH, 1095

Willowdale Road, Morgantown, West
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 53999

Virginia 26505–2888, telephone (304)

285–5907.

Availability and access of copies:

Additional copies of this notice can be

obtained by calling the NIOSH toll-free

information number (1–800–35-NIOSH,

option 5, 9 a.m.–4 p.m. ET); the

electronic bulletin board of the

Government Printing Office, (202) 512–

1387; and the NIOSH Home Page on the

World-Wide Web (http://www.cdc.gov/

niosh/homepage.html).

SUPPLEMENTARY INFORMATION: NIOSH

intends to propose technical modules in

the following areas:

1. Powered Air Purifying Respirator

(PAPR)—Establishment of N, R, and P

series filters; Use of active low flow or

low pressure warning devices; and

Addition of new duration ratings.

2. Airline Respirator—Single airline

for pneumatic devices and breathing air;

Airline suits (i.e., Department of Energy/

Los Alamos National Laboratory suits);

Metabolic simulator tests; Air flow/

pressure rate requirements; and Air flow

measuring and warning devices.

3. Self Contained Breathing Apparatus

(SCBA)—Maximum weight limit, with

accessory definition; Upgrade of

cylinder air specifications;

Incorporation of National Fire

Protection Association (NFPA)

requirements; Non-facepiece SCBA;

Metabolic simulator tests; Air flow/

pressure rate requirements; and

Alternatives to Department of

Transportation and Compressed Gas

Association requirements.

4. Gas and Vapor Respirator—

Certification to a wider variety of

specific substances and addition of

service life categories.

NIOSH intends to propose three

Administrative/Quality Assurance

modules. The intended subjects for

these modules are:

1. Corrections to 42 CFR part 84 and

existing program policies not included

in the regulations.

2. Upgrade of Quality Assurance

requirements; Use of independent

quality auditors in the certification

program and updated fee schedule.

3. Use of independent testing

laboratories in the certification program

and restructured fee schedule.

I. Background

On May 16, 1996, NIOSH published a

document in the Federal Register (61

FR 24740) to request public comments

on what the agency’s priorities should

be in the area of respirator certification.

NIOSH sought public comments on

issues of privatization and fees related

to possible changes in its administration

of respirator certification, and

comments on establishing priorities for

future rulemaking. NIOSH held three

public meetings in June 1996 to discuss

these issues. All comments provided in

response to the notice were considered

in developing the rulemaking priorities.

II. Public Comment on Priority Issues

Thirty-two commenters responded to

the document including: eleven

respirator manufacturers, seven private

sector testing and certification

laboratories, five safety professionals,

two public utilities, two trade or

manufacturers’ associations, one Federal

agency, one National Laboratory, one

fire department, one professional

society, and one respirator accessory

manufacturer.

III. Ranking Criteria for Technical

Modules

NIOSH requested input on what

determinants should be used as the

criteria to rank the priority of each

module, in addition to

recommendations for module subject

areas. The determinants for ranking

listed in the notice were; consideration

of the number of persons (workers)

affected, the seriousness of hazards or

problems that would be addressed, the

extent to which changes would improve

protection, opportunity for cost savings

(reducing costs for manufacturers and

purchasers of respirators) and the

expediency by which a change could be

implemented (e.g., the existence of

adoptable consensus standards).

NIOSH specifically sought comments

on the following issues for prioritizing

the development of modules: the criteria

to prioritize each module, existing

national or international standards that

could be adopted to replace current

NIOSH certification requirements, and

public health effects of any

recommended changes.

A. Discussion of Comments Received

Commenters generally agreed with the

determinants listed in the notice. Two

commenters stated that allowing

flexibility of design and innovative

approaches to design and use, as well as

encouraging new product development

should be included in the priority

ranking criteria.

B. Conclusions

NIOSH believes that the ability to use

innovative approaches and flexibility in

design results in new product

development. Performance standards

allow manufacturers to use innovative

approaches and flexibility in design,

resulting in new products to address

hazards. NIOSH intends to develop

performance-based technical criteria to

the extent possible in its rulemaking

activities. Therefore, although neither of

these suggestions were included as

determinants in the priority ranking

criteria, NIOSH expects both will result

from the rulemaking activities.

The ranking criteria used to develop

the module priority order was: the

number of workers affected, the

seriousness of hazards or problems that

would be addressed, the extent to which

changes would improve protection, the

expediency by which a change can be

implemented (e.g., the existence of

adoptable consensus standards), and

opportunity for cost savings (reducing

costs for manufacturers and purchasers

of respirators).

IV. Technical Module Priority

NIOSH requested input to develop a

complete, ranked list of priorities for

rulemaking, including justification for

the ranking. NIOSH specifically sought

comments on the following issues for

module development ranking: changes

needed to current respirator certification

requirements in the modules identified

in the notice, subject areas for

improving current certification

requirements not identified in the

notice, suggested module rankings, with

ranking criteria and data or reasoning,

industries and workers affected by

potential changes, technical feasibility

of suggested changes, economic impact

to respirator manufacturers, purchasers,

and users, and other factors related to

the priority ranking.

A. Discussion of Comments Received

NIOSH has developed a ranked list of

priorities for rulemaking, including

justification for the ranking based on the

comments received. Areas

recommended for modification by

commenters were grouped into feasible

modules, then ranked according to the

priority ranking criteria. The ranking

justifications, based on the available

supporting information, are included

with the listing of the identified

modules in IV.B. Conclusions.

The purpose of this notice is to inform

the respirator community of regulatory

priorities to allow research and

planning to be coordinated with the

development of new standards. NIOSH

research and development efforts will

be directed primarily at the highest

priority areas identified in this notice.

NIOSH also encourages others in the

respirator community to conduct

research in the identified module areas.

Research results and planning

information for the regulatory priorities

identified in this notice should be

submitted to the NIOSH docket when

they become available. The information

will then be in a forum for public
54000 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

review and comment. The information

received in the NIOSH docket will

establish a database to help develop

future regulatory proposals.

Most of the determinants in the

ranking criteria are based up the

agency’s current understanding of the

capabilities of the manufacturing

community as well as the science upon

which the product development is

based. Chief among these is the

expediency by which a change can be

implemented. NIOSH has attempted to

estimate the research needed for each

identified module in this priorityranking process. It must be recognized

that module development will be based

on the successful completion of research

in most of the identified module areas.

Therefore, the rulemaking order of the

identified modules may vary slightly

from the priority order identified in this

notice.

B. Conclusions

The following module list identifies

the priority assessment for development

of technical improvements based on the

information provided by commenters:

1. Powered Air Purifying Respirator

(PAPR)

Areas for potential modification in

this module are: Establishment of N, R,

and P series filters; Use of active low

flow or low pressure warning devices;

and Addition of new duration ratings.

The regulations require the PAPR

battery to have a service time sufficient

to maintain a stated air flow throughout

4 hours of operation during a silica dust

loading test with particulate filters.

One commenter stated that the

current requirements result in units that

are too heavy and burdensome for most

applications. Another commenter

specifically suggested that modifications

should be made to allow a light weight

hood type PAPR for the health-care

industry.

One commenter recommended the

requirement of low flow and negative

pressure warning devices to assure

workers are protected from

overbreathing the PAPR air supply. This

commenter also recommended the

establishment of a pressure demand

PAPR. Two other commenters suggested

the use of these devices and breathingassist devices to establish positive

pressure and negative pressure classes

of PAPR’s. These commenters indicated

that PAPR duration may be able to be

defined by an active alarm from a low

pressure or low flow sensor, signaling

an end of the battery’s service life.

Presently, the filter choices for use

with PAPR’s has been limited to only

high efficiency particulate air (HEPA)

filters with the implementation of part

84. Commenters indicated that

additional choices are necessary.

Four commenters stated that the

regulations should be modified to

include the same filter classes for

PAPR’s as are provided for non-powered

filter respirators under 42 CFR 84. PAPR

filter testing was included in the

proposed 42 CFR 84 (59 FR 26850), but

was not included in the final rule

because additional research is needed to

make the proposed tests more feasible

and consistent with the part 84 filter

tests.

Seven commenters indicated that

PAPR requirements should be the top

priority for technical revision of the

regulations. The possibility of increased

worker protection with lighter, cheaper

units was represented by most of these

commenters.

Estimates of more than 500,000 PAPR

users in chemical, health care,

pharmaceutical, agriculture and welding

were provided by a commenter.

2. Airline Respirator

Areas for potential modification in

this module are: Single airline for

pneumatic devices and breathing air;

Airline suits (i.e., Department of Energy/

Los Alamos National Laboratory suits);

Metabolic simulator tests; Air flow/

pressure rate requirements; and Air flow

measuring and warning devices.

Presently, 42 CFR part 84 does not

contain a respirator classification that

allows a single airline to the person for

pneumatic devices and breathing air.

NIOSH has recommended against this

practice due to concerns over potential

contamination of the air supply, and the

high potential for negative impacts on

respirator performance. In the absence

of a dedicated breathing-air system,

there is an increased risk of a

contaminated air supply and negative

impacts on respirator performance due

to: backflow of contaminants from the

pneumatic device line to the respirator

air supply, low air flow and pressure to

the respirator from a severed pneumatictool line, and excessive air flow and

pressure from a blocked pneumatic-tool

line.

Four commenters asserted that the

breathing air could be filtered to Grade

D specifications at the person wearing

the respirator (e.g. on the belt). They

stated that technology is available to

ensure that an air filtering system

incorporated into a respirator design

would provide Grade D breathing air at

the wearer, and this design should be

certified by NIOSH. One of the

commenters indicated that by providing

safeguards against robbing air from the

respirator, or feedback from pneumatic

tools, a criteria could be developed for

supplied air respirators (SAR) that allow

a single airline for tools and breathing

air. The use of air flow or pressure

devices were suggested to provide

needed assurances and warning of

appropriate user air supply. Three of the

commenters indicated that appropriate

European standards that NIOSH could

adopt exist for such a respirator class.

Presently, there is a standardized set

of exercises and work rate criteria used

in the evaluation of SAR’s. The use of

a metabolic simulator for testing was

recommended by two commenters to

help eliminate the variability associated

with human testing. According to

several commenters, the criteria for

certifying SAR’s could be upgraded by

modifying the class criteria to reflect

differing work rates with minimum flow

rates and pressure differential from

atmosphere. This would result in new,

additional classifications for SAR’s. One

commenter recommended the use of air

flow volume measuring and low flow

warning devices. Three commenters

suggested that a positive pressure class

be defined. Another commenter

suggested that a positive pressure

within the facepiece should be required

at the tested work rate.

Two commenters stated that a criteria

is needed for NIOSH-acceptance of

airline suits for respiratory protection.

These commenters asserted that airline

suits (i.e., Department of Energy/Los

Alamos National Laboratory suits) have

been used for respiratory protection

against hazardous and toxic substances

for twenty years under a Department of

Energy acceptance program. In addition

to respiratory protection, one of the

commenters stated that the suits provide

benefits such as total body protection

and relief of heat stress. A Los Alamos

National Laboratory evaluation protocol

(LA–10156–MS) was recommended for

as an acceptable criteria by both

commenters.

Estimates of 50,000 auto body shops

with over 100,000 workers, with

additional unnumbered workers in

other industries were given by one

commenter as potential users of single

airline respirators.

Several commenters stated that

workers were improperly protected

because the NIOSH-certified supplied

air respirators were not conducive to

use because they require two airlines to

separate pneumatic device air from

breathing air. Estimates were given that

less than 5% of U.S., more than 95% of

British, and more than 90% of European

auto painters use proper respirators.

Cost savings and greater user acceptance

were projected based on the possible
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54001

elimination of the installation and

maintenance of a second airline.

3. Self Contained Breathing Apparatus

(SCBA)

Areas for potential change in this

module are: maximum weight limit,

with accessory definition; Upgrade of

cylinder air specifications;

Incorporation of NFPA requirements;

Non-facepiece SCBA; Metabolic

simulator tests; Air flow/pressure rate

requirements.

Presently, 42 CFR part 84 limits the

weight of a completely assembled and

fully charged SCBA apparatus to 35

pounds for most units. A maximum

weight of 40 pounds is allowed only

where the weight decreases by more

than 25 percent of its initial charge

weight during its rated service life or

where an apparatus employs a cooling

system. NIOSH does not include the

weight of accessories in the total weight

of a respirator.

Four commenters suggested that the

maximum weight limit of an SCBA

apparatus should be permitted to exceed

35 pounds where other fire fighter

protective clothing or equipment is

incorporated with the SCBA. One of

them recommended a definition for

accessories is needed to better define

those items not included in the weight

calculation. These commenters stated

that this change could result in more

comfort, greater protection, and a lower

overall ensemble weight for fire fighters.

Presently, there is a standardized set

of exercises and work rate criteria used

in the evaluation of air supplied

respirators. According to several

commenters, the criteria for certifying

SCBA’s could be upgraded by modifying

the class criteria to reflect differing work

rates with minimum flow rates and

pressure differential from atmosphere.

This would result in new, additional

classifications specifically for SCBA’s.

One commenter recommended the use

of air flow volume measuring and low

flow warning devices. Three

commenters suggested that a positive

pressure class be defined. Another

commenter suggested that a positive

pressure within the facepiece should be

required at the tested work rate. One

commenter suggested that the

requirements for open circuit apparatus

should be separated from the

requirements for closed circuit

apparatus.

The use of a metabolic simulator for

testing was recommended by two

commenters to help eliminate the

variability associated with human

testing.

Incorporation of standards consistent

with life support efficacy portions of the

NFPA requirements were recommended

to upgrade the current standards. Three

commenters stated that some NFPA

1981–1992 requirements should be

included in the NIOSH requirements.

Higher air flow rates and lens abrasion

resistance were provided as examples.

One of these commenters recommended

the incorporation of NFPA 1981–1992

for fire fighter SCBA, with some of the

requirements applicable to all SCBA.

This commenter also stated that the dew

point and particulate level requirements

of NFPA 1500–1992 should be required

for SCBA cylinder air.

One commenter requested provisions

be developed for NIOSH to approve

SCBA without a facepiece. This

commenter asserted that the National

Aeronautics and Space Administration

(NASA) has used non-facepiece, suit

SCBA since the early 1960’s without

any serious problems. This commenter

stated that similar suits are being

developed for decontamination and

decommissioning of Department of

Energy sites and other chemical waste

sites. The commenter recommended a

revision to the regulations to allow

NIOSH certification of this class of

respirator.

One commenter suggested that NIOSH

should accept alternatives to

Department of Transportation (DOT)

and Compressed Gas Association (CGA)

cylinder requirements. This commenter

asserted that a cylinder could be

incorporated as an integral part of the

SCBA design without a standardized

CGA cylinder thread, which is design

restrictive. The commenter also

recommended that cylinder acceptances

of other certifying agencies throughout

the world be recognized as equivalent to

the United State’s DOT requirements.

No user population size or overall user

type estimates were provided by

commenters for SCBA. However, NIOSH

is aware of estimates of the number of

fire fighters in the U.S. While not

representing users of all SCBA, fire

fighters are believed to be a significant

portion of the SCBA user population.

According to the National Fire

Protection Association’s (NFPA) 1995

Fire Department Profile, there are

1,098,850 fire fighters (260,850 career

and 838,000 volunteer) in the United

States. According to the National

Volunteer Fire Council, a non-profit

membership association representing

the interests of the volunteer fire,

emergency medical, and rescue services,

there are 1.5 million volunteer

firefighters who staff more than 28,000

fire departments throughout the United

States. The International Association of

Fire Fighters (IAFF) represents over

225,000 professional fire fighters and

emergency medical personnel in the

United States and Canada. In 1992,

NIOSH estimated 400,000 firefighter

SCBA’s were in use by some 200,000

full time and 1,000,000 volunteer and

non-municipal firefighters in the U.S.

4. Gas and Vapor Respirator

Areas for potential modification in

this module are: Certification to a wider

variety of specific substances and

addition of service life categories.

Presently, NIOSH certifies gas and

vapor (chemical cartridges included)

respirators only to provide protection

against only sixteen specific substances.

Gas mask canisters and chemical

cartridges may be classified for

protection against the general category

of organic vapors. Gas mask canisters

may also be classified for protection

against the general category of acid

gases. Their use against substances with

poor warning properties has not been

recommended.

One commenter stated that there is a

need for a new class of respirators for

protection against the accidental release

or terroristic use of chemical agents.

This commenter asserted that local law

enforcement, first response teams, and

local and state agencies are seeking and

need NIOSH-certified respirators in

responding to these events. The use of

existing facilities that test and evaluate

equipment against chemical warfare

agents for the military was proposed as

an alternative to new NIOSH facilities.

The current standards in 42 CFR 84

provide for a canister or cartridge

absorption capacity test criteria based

on the respirator type. Two commenters

indicated that NIOSH-certified canisters

and cartridges are heavy and bulky

because of too severe service life

requirements. They asserted that various

service times (or sorbent capacities)

could be appropriately used, based on

the conditions of use. They

recommended modifying the

certification standards to include other

service time possibilities and absorption

capacities under additional test

parameters. One of these commenters

recommended the regulations be

modified to allow for certification of

three cartridge capacity sizes by using

three challenge levels of exposure for

certification, similar to the European

standards.

No precise user population estimates

were cited by commenters. Users were

identified only as unnumbered workers

such as law enforcement personnel and

first response teams with accidental

release of chemical agents and chemical

warfare agents.
54002 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

V. Notification of Revised Priority

Assessment

A. Comment Request

NIOSH will readily notify respirator

manufacturers directly about changes to

the regulatory priorities established in

this notice. NIOSH specifically sought

comments on how respirator purchasers

and users should be notified of revised

priorities.

B. Discussion of Results

Commenters suggested various

mechanisms for notifying respirator

purchasers and users of revised

priorities. One commenter suggested the

use of a Respirator Users’ Notice. Three

commenters suggested the use of the

NIOSH internet Web site. Three

commenters recommended the

information be published in safety

industry newspapers, magazines, and

newsletters like the BNA ‘‘Occupational

Safety and Health Reporter’’. Two

commenters suggested the use of

another Federal Register notice. One

commenter each suggested that the

respirator manufacturers, sales and

marketing managers, and major users

groups like the American Industrial

Hygiene Association (AIHA), Chemical

Manufacturers Association (CMA),

National Association of Manufacturers

(NAM), and American Iron and Steel

Institute (AISI) be used to notify

respirator purchasers and users.

C. Conclusions

NIOSH has established the priorities

for rulemaking based on the comments

received to the May 16, 1996 request.

However, these priorities may change as

new needs are identified or unforeseen

delays are encountered with research

efforts. New modules may be needed to

respond to emerging hazards and

developing technology.

Commenters failed to reveal any new

mechanisms for NIOSH use to better

disseminate rulemaking priority

updates. NIOSH has used respiratorrelated mailing lists (including the

Users Notice List and Respirator

Manufacturers List), the NIOSH internet

Web site, the Government Printing

Office electronic bulletin board, press

releases, and the NIOSH toll-free

information number to disseminate

Federal Register notices.

Publication of the information in

safety industry newspapers, magazines,

and newsletters is dependent on the

publishers’ expectations of reader

interest. Dissemination of the

information by the respirator

manufacturers, sales and marketing

managers, and major users groups

depends on their willingness and ability

to relay the information to their

clientele. NIOSH respirator-related

mailing lists have historically been

generated as a result of public

comments or a request for respiratorrelated publications. World-Wide Web

and electronic bulletin board listings

rely on the reader to go to the site to

find the information.

NIOSH will continue to disseminate

Federal Register notices as in the past,

while continuing to seek better

notification methods.

VI. Administrative and Quality

Assurance Issues

A. Private Sector Testing Laboratories

Specifically, NIOSH sought comments

on the following issues for the potential

use of private sector testing laboratories

for the certification process:

• Capability of private sector testing

laboratories to conduct the respirator

testing currently performed by NIOSH.

• Qualification requirements of

private laboratories if they were to

perform certification and product audit

testing under NIOSH guidance.

• Assignment of a manufacturer’s

respirators to testing laboratories by

NIOSH or manufacturer choice among

approved laboratories.

• Monitoring of private sector

laboratories to assure quality service

would be continued if they were to

perform certification and product audit

testing under NIOSH guidance.

1. Discussion of Comments Received

Many of the commenters endorsed,

with reservation, the idea of

empowering private sector testing

laboratories to conduct the NIOSH

certification testing. Concerns about

NIOSH’s ability to empower these

laboratories were raised by most of the

commenters. These concerns centered

around (1) the existence of lab

capability in the private sector, (2)

impartiality and credibility of testing

and (3) documentation of the NIOSH

testing procedures and reproducibility

of results.

Five commenters questioned the

existence of testing laboratory capability

in the private sector. Nine commenters

supported the belief that private sector

testing laboratories are capable of

performing the NIOSH testing. Several

of these commenters indicated that the

testing ability and capacity currently

exists with certification of self

contained breathing apparatus to NFPA

requirements. They further stated that

added capacity would be quickly

obtained for other respirators once the

market was there.

Five commenters stated that the

documentation of the NIOSH testing

procedures need to be improved before

other testing authorities should be

authorized to conduct the certification

testing. These commenters expressed

concern that test results would not be

reproducible among a number of testing

facilities. That is, test results could vary

from laboratory to laboratory without an

inter-laboratory validation program.

Concerns were raised by several

commenters that impartiality and

credibility would be lost with the

testing portion of the certification

process removed from NIOSH control.

One commenter was concerned that any

laboratory not have any vested interest

in the certification of products or with

manufacturers. A few commenters

indicated increased NIOSH staff would

be more productive than using private

sector laboratories. These commenters

felt that NIOSH resources would be

consumed with oversight of accredited

laboratories.

Another commenter stated that the

survivability of private sector testing

laboratories depends on their ability to

demonstrate impartiality and credibility

in their test results. Several other

commenters indicated that use of

already established accreditation or

certification programs would require

little or no additional NIOSH oversight.

Four commenters indicated that the

European experience with privatization

and U.S. certification authorities such as

the NFPA and Safety Equipment

Institute (SEI) have been good.

Experiences with favorable turnaround

times and costs were reported.

Commenters recommended that

NIOSH adopt an existing system, rather

than create a new one. Three

commenters recommended

accreditation by the American National

Standards Institute (ANSI) to ANSI

Z34.1. This standard was judged

inappropriate for lab privatization by

another because it is a complete

program that includes design, QA and

product testing requirements for the

certification of manufacturers’ products

by the authorized entity. This is similar

to the current NIOSH process. ISO

Guide 25, a tool to assess and accept a

laboratory’s calibration and QA

procedures for accurate and consistent

results, was recommended by four

commenters. Two more commenters

suggested that NIOSH should become

ISO certified as well.

2. Conclusions

NIOSH agrees with those commenters

who stated that the use of private sector

testing laboratories could expedite the

approval process and the availability of

the latest and safest technology. This

will be accomplished only if the use of
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54003

these laboratories increases the

resources available to conduct the tests.

NIOSH shares the concern expressed by

some commenters that an insufficient

business base may exist to assure the

increased resources, quality level and

cost would be acceptable.

Private sector testing laboratories can

be utilized in the certification of

respirators, provided that adequate

procedures and safeguards are in place.

No existing testing laboratory

accreditation or certification programs

have standards and procedures that

accredit or certify laboratories to

perform the NIOSH tests. The

procedures and standards to accredit or

certify testing laboratories to conduct

the NIOSH tests need to be developed

before a laboratory could be accredited.

Clear, objective test requirements and

protocols that provide test results

reproducible between laboratories also

need to be finalized and made available

before most NIOSH tests can be used by

private testing laboratories.

NIOSH has determined that there are

private sector testing laboratories with

the capability to perform the NIOSH

tests. However, NIOSH is concerned

that there is insufficient testing capacity

to meet the demand for testing. NIOSH

has seen no evidence that this capacity

is present, especially considering the

comments that refined procedures are

needed to allow others to conduct the

NIOSH tests. Efforts to develop testing

laboratory certification and auditing

criteria will consume some NIOSH

resources to establish the program.

NIOSH is continuing to explore

options for the potential use of private

sector testing laboratories for the

certification process. However, the

infrastructure to define and support the

use of these laboratories remains to be

established. NIOSH intends to propose

an Administrative module to address

the use of private sector testing

laboratories for the certification process

after the infrastructure needs are better

determined.

B. Private Sector Quality Auditors

Specifically, NIOSH sought comments

on the following issues for the potential

use of private sector quality auditors for

the certification process:

• Qualification requirements (e.g.,

certification by ANSI-Registrar

Accreditation Board, United Kingdom

Accreditation Service, International

Auditor and Training Certification

Association, etc.) of independent quality

auditors if they were to perform

manufacturing site audits under NIOSH

guidance.

• Assurances of integrity for a

program using private quality auditors.

• Frequency of audits needed to

assure that only quality products are

distributed.

• Auditing of manufacturing sites

prior to the issuance of a NIOSH

certification.

1. Discussion of Comments Received

No commenters opposed the use of

private sector quality auditors for the

certification process. Three commenters

endorsed the use of the International

Organization of Standardization

certification standards (ISO) for

evaluation of the manufacturers’ quality

assurance systems. Two of these

commenters pointed out that,

specifically, ISO 9001 should be

adopted because it documents the

design and development process, unlike

ISO–9002.

The ISO standards were perceived by

several commenters as sufficient to

ensure the integrity of the program. One

commenter stated that the ISO system

requires auditors to be certified by

authorities such as Underwriters

Laboratories. A commenter stated that

NIOSH must develop the criteria for an

acceptable quality assurance plan for

use by an ISO auditor. Two commenters

believed that ISO 9001 audits could be

used instead of NIOSH audits because

the ISO audit would ensure the quality

assurance plan is met. These same

commenters thought that the ISO

semiannual or annual frequency of audit

was appropriate.

Two commenters pointed out that ISO

9000 requires site audits prior to

registration. Therefore, if a manufacturer

has been ISO-certified, they stated no

NIOSH pre-certification audit would be

needed. If the manufacturer has not

been ISO-certified or is a new

manufacturer, they stated that a NIOSH

pre-certification audit would be

appropriate.

2. Conclusions

Qualified quality auditors may be

used to perform site audits for

verification that the manufacturers’

quality systems are being followed and

are appropriate. Empowering qualified

auditors would expand the audit

portion of the certification program to

levels consistent with most

contemporary certification authority

requirements. NIOSH has been

developing audit guidelines that could

enable a qualified auditor to evaluate

compliance with the salient points of a

manufacturer’s quality assurance plan.

NIOSH is evaluating the

appropriateness of the ISO 9000 series

standards with NIOSH-added

requirements specific to respirators, or

equivalent, to evaluate a manufacturer’s

quality system. NIOSH is also

considering requirements for

certification of auditors, and the

oversight needed to ensure that audit

quality is comparable to that which has

been provided by NIOSH employees.

Audits conducted by independent

auditors would be used to complement

NIOSH audits. The requirement for a

pre-certification audit is also under

evaluation. NIOSH intends to address

the use of private sector quality auditors

for the certification process in an

Administrative/Quality Assurance

module to be proposed in the near

future.

C. Fee Schedule

Specifically, NIOSH sought comments

on the following issues for updating the

fee schedule to reflect the actual costs

to maintain the program:

• Certification fee structure and

calculation to recoup the cost of the

certification process.

• NIOSH fee collection for

manufacturing site and product audits.

• NIOSH fee collection for respirator

complaint investigations.

1. Discussion of Comments Received

Eight commenters supported fair fee

charges that accurately reflect the

services received. These commenters

stated that fees should be fair and

equitable to NIOSH and the

manufacturers. One of these

commenters noted that excessive fees

would be a deterrent to improving

products, while another stated a

willingness to pay more for faster

approval. Two commenters

recommended that collected fees be

retained in the certification program to

make it self-sustaining.

Five commenters did not think that

NIOSH should recoup all costs of the

program. One of these commenters felt

there should not be charges for site and

product audits. The other four argued

against fees for product complaint

investigations. One of them suggested

there could be challenge procedures

where the loser pays the investigative

costs for a complaint. Another stated

that the manufacturer should not be

responsible for most complaints,

because they are minor or frivolous.

Another commenter believed that fees

would be unfair because the

manufacturer may not necessarily be at

fault. The fifth commenter felt that

NIOSH should bear the cost of

complaint investigations because they

are a NIOSH responsibility. Three of

these commenters did indicate,

however, that a fee may be appropriate

if the basis for the complaint is
54004 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

determined to be the manufacturer’s

fault.

Five commenters specifically

endorsed a NIOSH fee to recoup the

total cost for audits. One of these

commenters stated that this would not

be an additional expense for NIOSH or

ISO-certified manufacturers if NIOSH

accepted the results of ISO audits.

Conversely, this commenter believed

that NIOSH should conduct audits and

charge fees to recoup their cost for

manufacturers not ISO-certified.

Another of these commenters suggested

that the original fees that NIOSH

charges for issuing a certification should

include the costs of site and product

audits.

One commenter stated that the fees

should relate to all the tasks performed

in the certification process. Another

stated that the fee structure should

include fees for each discrete,

identifiable part of the process. A third

commenter supported flat fees as the

preferred fee structure. This commenter

also stated that NIOSH should charge an

hourly rate based on staff time and

supply costs if flat rates can’t be

calculated. Two commenters suggested

an annual maintenance fee based on the

number of units produced or sales. One

of these commenters further stated that

an annual fee should be collected per

model.

Two commenters suggested that fees

should be reviewed and recalculated

annually. Another commenter stated

that the fees should be computed based

on actual costs, and published for

comment.

Several commenters recommended

that collected fees be retained in the

certification program to make it selfsustaining.

One commenter requested the

establishment of fee accounts for

withdrawal of fees when due.

2. Conclusions

The fees and fee structure for

activities conducted in the certification

program are currently based on the fee

schedule contained in 42 CFR part 84.

This fee schedule has not been updated

since 1972. The costs of conducting a

certification program have risen over the

years, but these increased costs have not

been reflected in certification charges.

The fees charged for NIOSH services do

not recover the costs to maintain the

program.

NIOSH intends to update the current

fee structure to offset the expenses and

administrative costs of the program.

NIOSH intends to update the current fee

structure in an Administrative/Quality

Assurance module to be proposed in the

near future. For future updates in the

fees, NIOSH may consider other fee

structures to better cover the program

costs.

D. Component Part Certification

Specifically, NIOSH sought comments

on the following issues for evaluation

and certification of respirator

component parts:

• Authorization of manufacturers

other than the original respirator

manufacturer for replacement parts.

• Effectiveness of replacement parts,

if alternate suppliers for replacement

parts were allowed.

• Component-specific requirements

of replacement parts, if alternate

suppliers for replacement parts were

allowed.

• Certification of respirator

components in addition to, or instead

of, complete respirators.

• Other certifying agencies or

standards organizations that allow

suppliers other than the original

manufacturer to provide replacement

parts for certified units.

• Monitoring of alternate suppliers, if

suppliers other than the original

manufacturer were permitted to provide

replacement parts.

• Monitoring of replacement parts, if

suppliers other than the original

manufacturer were permitted to provide

them.

• Interchangeability of parts by

design specifications, if alternate

suppliers for replacement parts were

allowed.

1. Discussion of Comments Received

Three commenters endorsed the

concept of component certification for

the manufacture and sale of replacement

parts by persons other than the

respirator manufacturer. Two of these

commenters stated that other standards

or certifying organizations, including

NFPA, allow third party replacement

parts. One commenter stated that lower

prices for respirators and disposable

parts would result from standards that

facilitate interchangeability of some

parts. Two commenters stated that the

replacement parts should be certified

just as complete respirators,

documenting equivalent form, fit and

function of the original respirator.

Component-specific requirements

should be able to be covered in the

general certification scheme, according

to one commenter.

Most commenters did not favor the

concept of component certification for

the manufacture and sale of replacement

parts by persons other than the

respirator manufacturer. Nine

commenters objected to allowing

replacement parts from a manufacturer

other than the respirator’s original

manufacturer. Respirator design

restrictions to allow interchangeability

of parts, copyright infringements and

liability concerns were expressed as

reasons for opposition.

Two commenters indicated that

replacement parts by others should be

permitted only if the manufacturer is in

agreement. Four commenters voiced

concerns of product liability of

replacement parts by others. One

commenter stated that the acceptable

use of third party parts would encourage

copyright infringements.

Six commenters believed there would

be no way to verify original

specifications are met with other

manufacturers’ parts. Therefore, they

asserted, the certification program could

not assure respirator system

performance. Two commenters

supported certification of complete

respirators only. Two commenters

stated that other standards, including

SEI certification, Japanese, Korean, and

Australian loosely-EN-based standards

do not allow interchangeability of

components.

Four commenters pointed out that

interchangeability in Europe is allowed

only for certain components. Two of

these commenters asserted that the

conformity required for

interchangeability in Europe creates

design restrictions. One commenter

believed that developing componentbased requirements would be

horrendous. Another commenter

reported the European experience to be

that users don’t utilize the option to

obtain replacement parts from third

parties. One commenter pointed to

significant administrative expenses with

testing and certification of replacement

parts as another rationale for not

adopting this concept.

Five commenters stated that NIOSH

would need to monitor third party parts

and suppliers the same as respirator

manufacturers. Three commenters

stated that allowing replacement parts

by other than the respirator

manufacturer would require testing to

assure overall compliance of assembled

respirator.

Some of the commenters opposing the

concept recognized potential cost and

program savings if a limited component

certification program were developed.

Three suggestions were made for

components to be certified for use

within the assembly of a single

manufacturer’s components, to make a

complete respirator by the assembly of

certified components. The certification

for interchangeability of air lines and

some air-supplied respirator parts were
Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules 54005

also suggested as viable program options

by two commenters.

2. Conclusions

The certification standards limit

NIOSH to certify only complete

respirators. Component parts are not

evaluated independently. Any

component part, or replacement part,

certification program would require the

development of component-specific

requirements that ensure that the

respirator continues to perform

effectively.

No commenters raised safety or health

concerns to support development of a

component parts certification program.

Only economic benefits were provided

as reasons for support. Commenters

raised seemingly valid safety and

health, legal and technical concerns

opposing component parts certification.

Based on the comments received,

NIOSH is not developing a component

certification program at this time.

E. Product Auditing

Specifically, NIOSH sought comments

on the following issues for product

auditing of respirators:

• The maximum number of

respirators per year, aside from problem

investigations, that NIOSH should

request from a manufacturer, at no

charge to NIOSH.

• Acquisition of products for audit

(i.e., by voucher, reimbursement,

random selection by NIOSH at the

manufacturer or distributor).

• Reimbursement of NIOSH costs for

product audits.

1. Discussion of Comments Received

One commenter stated that there

should be no charge for conducting

product audits. This commenter stated

that auditing costs should be included

in the cost of government enforcement

activities. Another commenter believed

that, with the resources available to the

government, the government should pay

for all products it acquires. Five

commenters indicated that fees should

relate to the task, and that the total cost

for any audit should be charged. One of

these commenters thought that the

original fees for a certification should

include costs of site and product audits.

One commenter suggested that

products for audit should be selected

from the manufacturer’s warehouse

during site audits, as is done in other

programs. A second commenter

recommended a voucher system be used

to acquire audit samples from

distributors. This commenter stated that

it was important that the manufacturer

not be allowed to pre-screen audit

samples to assure compliance.

2. Conclusions

NIOSH has historically purchased

product audit samples from distributors.

Although NIOSH occasionally requests

audit samples from the manufacturer’s

inventory during site audits, products

for audit are predominately purchased

with appropriated funds. This severely

limits the number and type of products

that can be audited each year.

NIOSH is considering options to

obtain appropriate numbers of product

audit samples from manufacturers at no

cost to NIOSH. NIOSH intends to

address the acquisition of product audit

samples in an Administrative/Quality

Assurance module to be proposed in the

near future.

F. Approval Duration

Specifically, NIOSH sought comments

on the following issues for limiting the

time duration or number of units for

which a respirator certification would

be valid:

• Time limits for the NIOSH

certification to be valid.

• Conditions for renewing a NIOSH

certification, if it were time-limited.

• Recommended time limits for a

NIOSH certification and renewal, if it

were time-limited.

• Notification requirements for

changes in production status and the

number of produced units when

production is halted.

• Affect on purchasers and users if

the certification of their respirator

expires.

• Benefits to purchasers and users of

an expired certification.

• Benefits to purchasers and users of

knowing the number of respirators

produced under a certification.

1. Discussion of Comments Received

Generally, comments were divided on

the issue of time limits on an approval.

Five commenters opposed time limits,

while four commenters endorsed the

concept.

Suggestions for a renewal process

varied. One commenter suggested that

annual renewal should be required.

Another commenter pointed out that the

National Fire Protection Association’s

standard for firefighter SCBA

certification (NFPA 1981) requires

recertification every 5 years. Yet another

commenter stated that product

approvals of this type are generally

required to be requalified after a one to

five year period. One commenter

believed that a complete resubmittal

from the manufacturer of the product

should be required 9 years after

certification, or the authority to

manufacture and sell the product as

NIOSH-certified would expire in the

tenth year.

Commenters opposed to time or

quantity limitations contended that

certification expirations would cause

undue user confusion and be overly

burdensome on the manufacturers, and

users would not benefit in knowing the

population of specific models. One

commenter pointed out that similar

European requirements resulted in

increased cost and obstructed sales.

Several commenters also believed that

production and sales levels are

confidential to the manufacturer. Other

commenters contended that such

limitations were not needed because the

evolution of products through

technological advancements and

approval schedule updates will limit the

age of approvals that can remain active.

Three commenters suggested that

NIOSH could require production change

reports from the respirator

manufacturers. A fourth commenter

suggested that NIOSH could check the

production status of approved

respirators in conjunction with annual

quality audits. Two commenters

recommended that approvals be

classified as Active, Inactive or Obsolete

based on their production status. One of

these commenters suggested inclusion

of the production status in the NIOSH

Certified Equipment List (CEL). Yet

another commenter stated that users

would be notified of an approval’s

expiration by removal from the

equipment list.

2. Conclusions

NIOSH agrees with commenters who

asserted that user notification of the

status of NIOSH-certified respirators is

important. NIOSH also agrees with

commenters who believed that time or

quantity limitations on certifications

could create an added burden on

manufacturers and NIOSH by creating

added applications for recertification of

products.

NIOSH is aware that manufacturers

generally sell components individually

that can be used in configurations

covered under a number of

certifications. Therefore, potentially

little data exists to represent the number

of respirators sold or in use under a

specific approved design.

NIOSH has concluded that it would

not be appropriate or beneficial to

initiate time or quantity limitations on

certifications at this time. The purpose

of user notification on certifications

could be served by receiving production

status reports from respirator

manufacturers to indicate if the

respirator is currently being produced

(active), no longer produced but units in
54006 Federal Register / Vol. 62, No. 201 / Friday, October 17, 1997 / Proposed Rules

the field are supported with parts

(inactive), or no longer in production or

supported with replacement parts

(obsolete).

The status listing of Active, Inactive,

or Obsolete status is included in the

NIOSH certified equipment list (CEL). In

accordance with received comments,

NIOSH is requesting the manufacturers

to provide this production status

information as soon as it becomes

available, to update the CEL. NIOSH

intends to address the reporting of

production status information in an

Administrative/Quality Assurance

module to be proposed in the near

future.

VII. Priority of Quality Assurance/

Administrative Modules

Based on the comments received,

NIOSH intends to propose three

Administrative/Quality Assurance

modules. The intended subjects for

these modules are:

A. Corrections and Existing Policies

1. Discussion of Comments Received

One commenter recommended that

NIOSH publish technical amendments

to 42 CFR part 84 prior to any other

modules. Specifically, this commenter

requested clarification of the 200 mg.

filter loading levels for particulate filters

used in pairs.

One commenter suggested that air

purifying respirators with end of service

life indicators (ESLI) should be certified

for polyisocyanate catalyzed paints.

Several commenters stated that workers

were improperly protected because the

adequate NIOSH-certified (supplied-air)

respirators were not conducive to use.

Estimates of 50,000 auto body shops

with over 100,000 workers, with

additional unnumbered workers such as

law enforcement personnel and first

response teams with accidental release

of chemical agents and chemical warfare

agents were given.

Air-purifying respirators can be

certified with ESLI’s in accordance with

requirements published in the Federal

Register on July 19, 1984 (49 FR 29270).

That notice provided for the approval of

air purifying respirators with either

effective passive or active ESLI for use

against gases and vapors with adequate

warning properties or for use against

gases and vapors with inadequate

warning properties whenever there is a

regulatory standard already permitting

the use of air purifying respirators.

Two commenters suggested a module

to address self contained self rescuers

(SCSR) that are used in the mining

industry. Both commenters urged

development of a duration testing

protocol using a metabolic simulator to

replace human subject testing.

2. Conclusions

There are typographical errors in 42

CFR 84 to be corrected. There are also

a number of existing program policies

that have been developed since 1972

that are not included in the regulations.

Policies affecting areas such as ESLI for

air purifying respirators and service life

plans for SCSR, need to be codified in

the regulations as a single source for the

respirator approval requirements.

NIOSH will publish a module to make

corrections and incorporate all existing

certification program policies into 42

CFR 84.

B. Upgrade of Quality Assurance

Requirements and Fee Schedule

1. Discussion of Comments Received

As discussed previously in VI.B., no

commenter opposed the use of private

sector quality auditors in the

certification program. Commenters also

generally endorsed the use of ISO–9000

or similar quality assurance

requirements. NIOSH acceptance of

audits conducted by private sector

auditors was also generally

recommended by commenters.

As discussed previously in VI.C., the

majority of commenters supported fees

that reflect the costs of the certification

program.

As discussed previously in VI.F., a

number of commenters supported use of

the NIOSH CEL to notify respirator

users of the production status of

approved respirators.

2. Conclusions

NIOSH intends to publish a module to

address the use of independent quality

auditors, respirator production status

information and updated fees.

C. Use of Independent Testing

Laboratories in the Certification

Program and Restructured Fee Schedule

1. Discussion of Comments Received

As discussed previously in VI.A., a

number of commenters expressed

reservations about the ability of NIOSH

to use private sector testing laboratories

in the certification program. Several

concerns, such as the availability of test

procedures and the accreditation

method, were presented.

As discussed previously in VI.C.,

some of the comments on fee revision

recommended substantial changes to the

fees structure. These recommendations

included concepts such as: retention of

the fees in the certification program;

annual maintenance fees; and fees for

complaint investigations.

2. Conclusions

NIOSH intends to publish a module to

address the use of independent testing

laboratories and a restructured fee

schedule.

VIII. Continued Comments

As stated previously, NIOSH is

requesting additional comments and

information on content for the modules

identified and prioritized in this notice.

Comments for the need to prioritize

other module topics are also welcomed.

NIOSH will periodically review the

information in the docket to assist in

determining if a priority reassessment is

needed. Comments should be mailed to

the NIOSH Docket Office, Robert A. Taft

Laboratories, M/S C34, 4676 Columbia

Parkway, Cincinnati, Ohio 45226,

telephone (513) 533–8450, fax (513)

533–8285. Comments may also be

submitted by e-mail to:

DMM2@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.

Dated: October 8, 1997.

Linda Rosenstock,

Director, National Institute for Occupational

Safety and Health (NIOSH), Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97–27224 Filed 10–16–97; 8:45 am]

BILLING CODE 4163–19–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 97–210, RM–9166]

Radio Broadcasting Services; Soldiers

Grove, WI

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: This document requests

comments on a petition filed by Lyle

Robert Evans d/b/a Rural Radio

Company proposing the allotment of

Channel 290A to Soldiers Grove,

Wisconsin, as that community’s first

local FM broadcast service. There is a

site restriction 11.8 kilometers (7.3

miles) northeast of the community at

coordinates 43–28–16 and 90–40–21.

DATES: Comments must be filed on or

before November 24, 1997, and reply

comments on or before December 9,

1997.

ADDRESSES: Federal Communications

Commission, Washington, DC. 20554. In

addition to filing comments with the

FCC, interested parties should serve the

petitioner, as follows: Lyle Robert

Evans, d/b/a Rural Radio Company,