[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
