Acceptance of Applications for the Testing and Evaluation of Self-Contained Breathing Apparatus for Use Against Chemical, Biological, Radiological, and Nuclear Agents

Letter to All Interested Parties

Issue Date: December 28, 2001

From: Richard W. Metzler, Acting Director, National Personal Protective Technology Laboratory

Subject: Acceptance of Applications for the Testing and Evaluation of Self-Contained Breathing Apparatus for Use Against Chemical, Biological, Radiological, and Nuclear Agents

It is imperative that the first responder community be afforded effective respiratory protection in responding to terrorist events involving possible chemical, biological, radiological, and nuclear (CBRN) agents. Because of the recent national emergencies and the need to provide the first responder community with the best available protection immediately, the National Institute for Occupational Safety and Health (NIOSH, or "the Institute") will begin accepting applications on January 22, 2002, to test and evaluate self-contained breathing apparatus (SCBAs) for use against these CBRN agents. This letter informs applicants of additional requirements that an SCBA must meet for NIOSH approval and provides the procedures for submitting applications to participate in this voluntary program. In developing these procedures and standards, NIOSH has obtained individual input from potential users and potential applicants of these devices, as well as from experts in the field of chemical and biological warfare. NIOSH obtained this input in public meetings and in individual meetings with various interested parties. NIOSH believes that these standards are based on the best information presently available. However, because knowledge regarding protection against biological and chemical agents continues to evolve as research progresses, NIOSH will continue to accept written comments and suggestions on improving these procedures and standards, including comments on the fees for participation.

Written comments should be submitted by E-mail to npptl@cdc.gov or by mail to:

Attn: Records Room
Respirator Branch
NIOSH
National Personal Protective Technology Laboratory (NPPTL)
1095 Willowdale Road
Morgantown, WV 26505-2888

Please submit any written comments on the fees established in this package on or before March 22, 2002. NIOSH will not increase the fees for this program stated in this letter during the first year of accepting applications. However, if (based on the comments received) NIOSH decides to reduce the fees, it will refund to any applicant the fees previously paid by the applicant that exceed the new, reduced fee.

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 (OSHA), and the National Fire Protection Association (NFPA) to jointly work on developing standards for all types of counterterrorism 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 procedures for SCBA certification are consistent with the guidance of the Federal Emergency Management Agency (FEMA) and NFPA, which calls for the use of SCBAs when hazards are unknown (i.e., within the first hours of an event).

NIOSH initiates this voluntary approval program pursuant to 42 CFR Parts 84.60(b) and 84.63(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 a special approval and approval label identifying the SCBA as appropriate for use against CBRN agents.

Summary of the Requirements for Approval

NIOSH has determined that an SCBA must be evaluated against the following existing and additional criteria to be approved for use in providing protection against CBRN agents.

• Requirements for approval of an SCBA under 42 CFR Part 84 . Approval under 42 CFR Part 84 demonstrates that the SCBA is approved for industrial usage and requires the applicant to maintain a quality control program and documentation for the SCBA in accordance with Part 84.
• Requirements for compliance of an SCBA to the National Fire Protection Association (NFPA) 1981 . Certification by the NFPA demonstrates that the SCBA can meet the flame, heat, and other requirements of NFPA 1981 that are important for protection against hazards that may be present for first responders to a terrorist incident.
• Additional standards for special tests associated with resistance of chemical penetration and permeation and quantitative laboratory protection levels as specified in Attachment A . NIOSH and SBCCOM have determined that the vulnerabilities of SCBAs to CBRN agents necessitate two additional special tests. Test criteria have been developed to assess the extent to which the components and materials of the SCBA can be penetrated and permeated if the wearer is in a hazardous chemical environment for an extended period. The penetration/permeation test procedures and protocol are provided in Attachment B . The laboratory respirator protection level test assesses the respirator's ability to fit a wide range of facial dimensions. The test procedure is provided in Attachment C .
• Additional approval application requirements are described in Attachment D . Applications will be processed in the order in which they are received by the Institute. However, due to the expedited nature of the CBRN SCBA program, NIOSH will follow a flexible program for test and evaluation of SCBAs for a limited period of 1 year. NIOSH will process CBRN SCBA applications as a priority. NIOSH intends to allow an applicant to retain their position in the processing queue for a period of up to 2 months while corrections or modifications are made to address application deficiencies and test failures. NIOSH will also permit applicants to procure two additional agent tests, as needed, to test and implement effective design modifications to meet the standard. NIOSH specifically requests comments regarding the priority and flexibility needed to expedite implementation of this important program.

Notification to Users and Regulatory Agencies

NIOSH will maintain and disseminate an approval list for the SCBAs approved under this program. This list will be entitled "CBRN Self-Contained Breathing Apparatus" and will contain the name of the approval holder, 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 SCBAs 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 OSHA for dissemination to its district offices.

Respirator Identification/Labeling

NIOSH will authorize the use of an additional approval label on apparatus that demonstrate compliance to the CBRN criteria. This label is to be placed in a visible location on the SCBA backplate, e.g., on the upper corner or in the area of the cylinder neck. The addition of this label will provide visible and easy identification of equipment for its appropriate use. A sample label is shown below.

Cautions and Limitations for the CBRN SCBA, Attachment E , must be incorporated into the applicants instructions for use.

If you need more information, please contact NIOSH at 412-386-6111 or E-mail at npptl@cdc.gov.

Attachments:

Statement of Standard - Attachment A

Determination of Open Circuit, Self-Contained Breathing Apparatus (SCBA) Performance During Dynamic Testing Against Chemical Agents of Sarin (GB) Vapor and Distilled Sulfur Mustard (HD) Vapor and Liquid Standard Testing Procedure (STP) - Attachment B

Laboratory Respirator Protection Level Test Quantitative (High-Flow Deep Probe Corn Oil) for Self-Contained Breathing Apparatus With Full Facepieces Standard Testing Procedure (STP) - Attachment C

Procedures for Applying for CBRN SCBA Approval - Attachment D

Cautions and Limitations of Use for CBRN SCBA - Attachment E