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NOTE: This document is provided for historical purposes only.
DRAFT FOR DISCUSSION
This concept has been developed to evaluate components and identify procedures to retrofit previously deployed (field-deployed), NIOSH-approved full-facepiece, air-purifying respirators (APR) to chemical, biological, radiological, and nuclear (CBRN) approved configurations. The purpose of this program is to:
BackgroundIn a letter dated April 4, 2003 and sent to all to all respirator manufacturers, NIOSH announced plans to begin accepting applications to test and evaluate full-facepiece, air-purifying respirators for use against CBRN agents. Some approvals have been issued and additional applications are expected to be received. Prior to the April 2003 NIOSH announcement, manufacturers and users expressed the desire and need to upgrade equipment placed in service. The CBRN APR retrofit kits should increase the number of emergency responders afforded the protection provided by the NIOSH-approved CBRN APR. Requirements for the CBRN APR Retrofit Kit Program
The application must include the quality assurance provisions that will identify the resulting configuration and protections for each respirator updated under the CBRN APR retrofit Program. The manufacturer shall provide written evidence that the configuration of the full-facepiece is equivalent to the system that was evaluated as part of the CBRN APR approval. NIOSH CBRN APR Approval Procedure
Application ProceduresThe application package shall include four CBRN APR retrofit kits and four NIOSH-certified, tight-fitting, full-facepiece APRs. Two of the respirators submitted are to be from the light-condition of use and the other two from the heavy-condition of use. The manufacturer shall provide written evidence that the configuration of the full-facepiece is equivalent to the system that was evaluated as part of the CBRN APR approval. The evidence should include identification of the NIOSH certification number(s) with all of the applicable component parts, major assemblies, accessories, and rationale in the reason for application. The installation of the CBRN APR retrofit kits will be performed by a manufacturer trained and authorized technician in the presence of NIOSH representatives. The applicant may also retrofit the APR within their manufacturing facility using qualified technicians , and submit supporting documentation that the retrofit installation requirements have been followed . The application must include a description of the estimated frequency-of-use for the submitted APRs, and how this has been determined to be typical of the model’s use. The submitted APRs will be tested and evaluated to the special tests for Chemical Agent Permeation and Penetration Resistance Against Distilled Mustard (HD) and Sarin (GB) without further environmental conditioning. The application must include the quality assurance (QA) provisions for the retrofit kit and retrofit kit-applied-product configuration management in the form of all standard accountable QA documents and a listing of all applicable parts of the retrofit kit in the form of a bill of materials The application must support the APR industrial NIOSH-approved assembly matrix document that identifies all current 42CFR84, approved APR; plus the submitted CBRN APR retrofit kit. This listed configuration for each APR retrofitted under the CBRN APR retrofit program is linked to the assembly matrix via the specific drawing part number. The cost for processing a completed application (four retrofitted APRs) is $21,000. In instances where the pre-existing facepiece was unchanged for CBRN approval and the canister is the only other component of the CBRN APR approval, CBRN APR retrofit testing is not necessary. The applicant fee for document processing for an application that does not require testing is $1,000. Applications may be made following the standards application procedures available through the NPPTL web site: http://www.cdc.gov/niosh/npptl/resources/certpgmspt/pdfs/SAPJul2005.pdf NIOSH may request additional documentation or test samples from the manufacturer if it determines that such documentation or samples are necessary to evaluate the CBRN APR retrofit kit process application. If a CBRN APR retrofit kit fails testing, the extension of approval is denied. Note: Comments on the topics presented in this posting should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, M/S C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, Telephone 513–533–8303, Fax 513-533–8285. Comments may also be submitted by e-mail to niocindocket@cdc.gov . E-mail attachments should be formatted in Microsoft Word. Comments should be submitted to NIOSH no later than December 23, 2004 . Comments regarding CBRN APR Retrofit concept should reference Docket Number NIOSH-002 in the subject heading.
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