Voluntary Program for Acceptance of Applications for the Testing and Evaluation of Full-Facepiece APR for Use Against CBRN Agents

Letter to All Interested Parties

Issue Date: April 4, 2003

From: Roland J. Berry Ann, Branch Chief, Respirator Branch, National Personal Protective Technology Laboratory

Subject: Voluntary Program for Acceptance of Applications for the Testing and Evaluation of Full-Facepiece Air Purifying Respirators (APR) for Use Against Chemical, Biological, Radiological and Nuclear (CBRN) Agents

It is imperative that the emergency responder community be afforded effective respiratory protection in responding to terrorist events involving possible chemical, biological, radiological and nuclear (CBRN) agents. Due to ongoing concern of a potential terrorist event and the need to provide the emergency responder community with the best available respiratory protection as quickly as possible, the National Institute for Occupational Safety and Health (NIOSH) is instituting this voluntary approval program on an expedited basis. The Institute began accepting applications on March 24, 2003, to test and evaluate full-facepiece air purifying respirators (APR) for use against CBRN agents. This letter informs manufacturers of voluntary requirements that a full-facepiece air purifying respirator must meet in order to obtain NIOSH approval. It also provides the procedures for the submission of applications for these approvals.

In April 2000, NIOSH entered into a Memorandum of Understanding with the National Institute for Standards and Technology (NIST), the Occupational Safety and Health Administration, and the National Fire Protection Association (NFPA) to work on the development of standards for all types of counter-terrorism respiratory protective equipment. NIOSH and NIST initiated Interagency Agreements with the U.S. Army Soldier and Biological Chemical Command (SBCCOM) for development of respiratory protection standards, test procedures and laboratory support. The new requirements for full-facepiece air purifying respirator certification have been developed under these agreements, and are responsive to public comments NIOSH received during two public meetings, numerous stakeholder meetings and to the NIOSH docket.

NIOSH initiates this voluntary approval program pursuant to Title 42, Code of Federal Regulations , 84.60(b), 84.63(c), and 84.110(c). These sections provide NIOSH with the authority to issue approvals for respirators not specifically addressed in Part 84 and to develop additional requirements that the agency determines are "necessary to establish the quality, effectiveness and safety of any respirator used as protection against hazardous atmospheres." NIOSH will issue an approval and approval labels identifying the full-facepiece air purifying respirators as appropriate for use against CBRN agents.

Requirements for Approval

To be approved for use in providing protection against CBRN agents, NIOSH has determined that a full-facepiece air purifying respirator must be evaluated against the criteria defined in the Statement of Standard for Chemical, Biological, Radiological and Nuclear (CBRN) Full-Facepiece Air Purifying Respirator (APR) dated March 7, 2003. ( Attachment A )

Applications will be processed in the order in which they are received by the Institute. Priority of applications received on the same day will be based on a random selection from all applications received on that day. The applicant shall provide three complete respirator systems with the application. Two of the submitted units will be used for testing in accordance with Chemical Agent Permeation Resistance Against Distilled Mustard (HD) and Sarin (GB) Agent Requirement and one will be used for general examination. The applicant will have eight weeks following notification of successful completion of the GB and HD tests, to complete the application with data from pretesting conducted by or for the applicant and remaining test equipment. See Attachment B, Guidelines for Identification of Test Configurations for Exposure to GB/HD and Part Number Change Guidelines for use in determining respirator configurations for test: Attachment C, Test Equipment and Test Data: Approval Labels and Markings contains information for providing test equipment, test data and approval labels and Attachment E, CBRN APR Certification Costs , for test and evaluation fees and additional information about the application procedure.

Notification to Users and Regulatory Agencies

NIOSH will maintain and disseminate an approval list for respirators approved under this program. This list will be entitled CBRN Full-Facepiece Air Purifying Respirators and contain the manufacturer, model, component parts, accessories, and rated duration. This list will be maintained as a separate category within the NIOSH Certified Equipment List.

NIOSH will also disseminate the list of approved CBRN Full-Facepiece Air Purifying Respirators by maintaining the list on its website, www.cdc.gov/niosh/ , and seek to have it placed on or linked to other appropriate websites that disseminate information to the first responder community. In addition, NIOSH will supply the list to the Occupational Safety and Health Administration for dissemination to its district offices.

Respirator Identification / Labeling

In accordance with the requirements of paragraph 84.33 of Title 42, CFR, Subpart D, approval labels shall be marked with a CBRN Rating as determined by paragraph 4.2 Service Life, of the Statement of Standard for Chemical, Biological, Radiological and Nuclear (CBRN) Full-Facepiece Air Purifying Respirator (APR) dated March 7, 2003. For example, canisters tested for 30 minutes are marked CBRN as a watermark. CBRN canisters shall comply with color requirements of ANSI Z88.7. The canister/label color shall be olive (Munshell notation 7.5 Y 5/6). For canisters where the color markings are achieved by labeling, the canister body can be any color. Facepiece assemblies shall be permanently marked with "CBRN".

Cautions and Limitations for the CBRN APR, Attachment D , must be incorporated into the manufacturers' instructions for use and canister label.

If you need additional information, please contact: NIOSH 412-386-4000 or E-mail at npptl@cdc.gov.

Attachment A: Statement of Standard (including Figure 1, NIOSH CBRN Full Facepiece APR Mechanical Connector and Gasket)

Attachment B: CBRN APR Guidelines for Identification of Test Configurations

Attachment C: CBRN APR Test Equipment and Preapproval Test Data; Approval Labels and Markings

Attachment D: CBRN APR Cautions and Limitations

Attachment E: CBRN APR Certification Costs

CBRN APR Test Flow Chart