Occupational safety and health: Respiratory devices used to protect workers in hazardous environments; approval,
[Federal Register: August 24, 1999 (Volume 64, Number 163)]
[Proposed Rules]
[Page 46178-46179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au99-24]
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.
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:
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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]]
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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.
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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.
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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
Publication of Publication of Module
NPRM
final rule
Administrative/QA.......................
10/2000
06/2002 SCSR....................................
12/2001
06/2003 PAPR....................................
12/2001
09/2003
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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: NIOCINDOCKET@CDC.GOV. 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. 99-21890Filed8-23-99; 8:45 am]
BILLING CODE 4163-19-P
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