National Institute for Occupational Safety and Health; Approval of Respiratory Devices Used to Protect Workers in Hazardous Environments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

42 CFR Part 84

National Institute for Occupational Safety and Health; Approval

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.

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SUMMARY: NIOSH is announcing a change in priority order and projected

dates for publication of proposed rule amendments (modules) for

respiratory devices used to protect workers in hazardous environments.

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 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 is currently in the process of

developing modules to be proposed in the priority order below:

1. Administrative/Quality Assurance Module

Areas for potential modification in this module are: Upgrade of

Quality Assurance requirements; Ability to use private sector quality

auditors and private sector testing laboratories in the approval

program; Revised approval label requirements; Validated approval fit

tests; Updated and restructured fee schedule; and Fee retention in the

Respirator program.

[[Page 46179]]

2. Self Contained Self Rescuer (SCSR)

Areas for potential modification in this module are: Metabolic

simulator performance tests; Environmental tests (shock, vibration,

temperature); Hypoxia tests; Reliability assessment; and Minimum

performance requirements.

3. 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; Addition of new duration ratings; and Development of

new types, such as pressure-demand PAPRs.

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 approval, 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 rulemaking priorities.

NIOSH published a Notice for priority rulemaking in the Federal

Register on October 17, 1997 (62 FR 53998) based on the comments

received in response to its May 16, 1996 request. That Notice listed

four technical and three Administrative/Quality Assurance topic areas

for priority rulemaking. In establishing the priorities for rulemaking,

NIOSH acknowledged that those priorities may change to respond to

emerging hazards and developing technologies or unforeseen delays

encountered with research efforts. As established with that Notice, the

NIOSH Docket remains open for additional public input on priority needs

and module content.

Since that time, NIOSH has reconsidered those priorities due to

recent serious field problems with deployed Self Contained Self

Rescuers (SCSRs). Investigation of the problems with these respirators

has revealed reliability issues resulting in product recalls and

withdrawal of one product approval. NIOSH considers these recent

experiences and the resultant concerns raised about the use of SCSRs to

represent an emerging hazard requiring immediate attention. As a

result, NIOSH has reevaluated its previously-published regulatory

priority assessment to include an SCSR module as a priority. The

Institute has formed a committee to review SCSR issues to be addressed

in a module. Except for the addition of the SCSR module as the highest

priority in the technical area, the originally prioritized topic areas

remain unchanged.

To aid stakeholders in the respirator community in planning for

possible regulatory changes, the schedule below provides general

guidance for anticipating regulatory announcements.

Projected 42 CFR Part 84 Module Schedules

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Publication of Publication of

Module NPRM final rule

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Administrative/QA....................... 10/2000 06/2002

SCSR.................................... 12/2001 06/2003

PAPR.................................... 12/2001 09/2003

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II. Continued Comments

As stated previously, the NIOSH docket remains open for receipt of

additional comments and information on content for the modules

announced in this notice. Comments for the need to re-prioritize other

module topics also are welcome. 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: [email protected] E-

mail attachments should be formatted as WordPerfect 4.2, 5.0, 5.1/5.2,

6.0/7.0/8.0, or ASCII files.

Dated: August 18, 1999.

Bryan Hardin,

Acting Director, National Institute for Occupational Safety and Health,

Centers for Disease Control and Prevention.

[FR Doc. 99-21890 Filed 8-23-99; 8:45 am]

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