[Federal Register Volume 64, Number 163 (Tuesday, August 24, 1999)]
[Proposed Rules]
[Pages 46178-46179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21890]


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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]
BILLING CODE 4163-19-P