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Frank Palya

Frank Palya Ninth Annual Technology for Critical Incident Preparedness Conference and Exposition 2007 Hosted by U.S. Departments of Justice, Homeland Security and Defense November 7, 2007.

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Frank Palya

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  1. Frank Palya Ninth Annual Technology for Critical Incident Preparedness Conference and Exposition 2007 Hosted by U.S. Departments of Justice, Homeland Security and Defense November 7, 2007 Respiratory Protection for the First Responder Community Through Research, Standards Development and Certification

  2. Topics of Presentation • NIOSH-National Personal Protective Technology Laboratory (NPPTL) Hierarchy and Mission • NIOSH Statutory/Regulatory Authority • Certification • Personal Protective Technology Standards and Participation with other Standards Organizations • Standards Development through Research and Implementation of new Technology • What’s Next?

  3. NPPTL: Federal Agency Hierarchy HHS U.S. Department of Health and Human Services CDC Centers for Disease Control and Prevention National Institute for Occupational Safety and Health NIOSH NPPTL National Personal Protective Technology Laboratory

  4. NIOSH • Office of the Director, NIOSH • Office of Extramural Programs • Pittsburgh Research Laboratory (PRL) • National Personal Protective Technology Laboratory (NPPTL) • Located In Pittsburgh, PA • Established in July 2001 • Division of Respiratory Disease Studies (DRDS) • Division of Safety Research (DSR) • Health Effects Laboratory Division (HELD) • Education and Information Division (EID) • Division of Applied Research and Technology (DART) • Division of Surveillance Hazard Evaluation and Field Studies (DSHEFS) • Office of Compensation Analysis and Support (OCAS) • Research to Practice (R2P) • Spokane Research Laboratory

  5. NIOSH Personal Protective Technology (PPT) Vision & Mission The VISION is to be the leading provider of quality, relevant, and timely PPT research, training, and evaluation. The MISSION of the PPT program is to prevent work-related injury, illness and death by advancing the state of knowledge and application of personal protective technologies (PPT). PPT in this context is defined as the technical methods, processes, techniques, tools, and materials that support the development and use of personal protective equipment worn by individuals to reduce the effects of their exposure to a hazard.

  6. Statutory/Regulatory Authority for NIOSH to Issue Respiratory Protective Device Approvals • Authority for NIOSH to approve respiratory protective devices is derived from the Federal Mine Safety and Health Act of 1977 and Occupational Safety and Health Act of 1970 -Authority • Department of Labor; Occupational Safety and Health Administration (OSHA); 29 CFR Parts 1910. 132-138 requires employers to provide respirators certified by NIOSH under Title 42 Code of Federal Regulation (CFR) Part 84 – Respiratory Protective Devices -Statutory/Regulatory • To date, all existing NIOSH Respiratory Protective Device Standards for Protection against CBRN hazards were developed by Policy - Authority 42 CFR 84.63(c), 84.110 or 84.190 • Future Respirator Standards will be developed by Informal Rulemaking (Changing the 42 CFR 84) including future CBRN Standards

  7. Respirator Certification • Respirator certification • Application processing • Respirator testing and QA Plan evaluation • Post certification • Product and site audits • Respirator equipment evaluations

  8. Personal Protective Technology Standards Participation • Title 42 Code of Federal Regulation (CFR) Part 84 – Respiratory Protective Devices (42 CFR Part 84)- Regulatory • NPPTL participation with other Standards Developing Organizations (SDO) such as- Public outreach • American National Standards Institute (ANSI) • International Standards Organization (ISO) • National Fire Protection Association (NFPA) • American Standard for Testing Materials (ASTM) • Consensus Standards • Created by SDOs • Standards Setting Committees with balanced representation: • Users • Labor • Government • Academia • Subject Matter Experts

  9. CBRN Standards Development • Workshops/Committee Meetings • NIOSH-DOD-OSHA Chemical-Biological Respiratory Workshop & Report (March 1999) • Interagency Board (IAB) and DHS adoption of CBRN Respirator Standards • Inter Agency Agreements (IAA): Cooperation among NIST, RDECOM, OSHA, NIOSH, NFPA, and DHS • IAA’s with NIST and DOD’s RDECOM • Initial and continuing funding from NIST-NIJ/NIST-DHS/CDC • Memorandum of Understanding (MOU): RDECOM support for specific testing

  10. Research to Development of CBRN Standards Sequential Process • Hazard analysis • Protection determinations • Human and environmental factors • Standards concept paper (Public Meetings) • Test requirements benchmarked • Standard Test Procedure (STP) development, testing, and methodology validation

  11. Hazards from a CBRN Terrorism Event • Respiratory Hazards for First Responders (Law Enforcement, Fire, EMT and others) / First Receivers (Medical Community) were not well defined • Potential Hazards include Chemical, Biological, Radiological and Nuclear (CBRN) materials: • Chemicals include Toxic Industrial Chemical (TICs) and Traditional Military Chemical Warfare Agents (CWA) • Thousands of CBRN materials with different toxicities, quantities and physical and chemical properties that is a challenge for respiratory protection mechanisms • Concentrations of the CBRN agent is not characterized at the terrorist site: • May lack detection equipment for characterization • Toxicity data for CBRN agents are unknown • There is no known carbon that can absorb/adsorp every chemical

  12. Hazard Analysis and Selection • A hazard analysis was performed that identified the most likely CBRN agents and estimated contaminant concentration profiles for likely CBRN Terrorist venues with two CWA (GB and HD) and several TICs. • In an effort to reduce the number of certification tests necessary for the CBRN standard, 139 respiratory hazards were categorized into families. • Test representative agent(s) (TRA) required for each family of agents. • Biological and radiological agents are addressed as part of the particulate agent family and requires P-100 media.

  13. Special CBRN Performance Requirements Note: CBRN respirators meet advanced performance, design and quality standards, including special CBRN tests • Requirements for All CBRN Respirators • Live agent tests (LAT) • System testing against GB (Sarin) and HD (distilled sulfur mustard) • Laboratory Respirator Protection Level (LRPL) • Quantitative corn-oil, fit-factor test using human test subjects • Requirements for CBRN Air Purifying Respirators • Canister gas life tests • Address high physiological demand protection for multiple respiratory hazards • 139 respiratory hazards were categorized into families • 10 Chemical Test Representative Agents plus DOP for particulate Testing • Human Factors • Speech Intelligibility, Fogging, Field of View

  14. Technology Employed to test the CBRN LAT Requirements Live Agent Testing (LAT) • Respiratory systems are challenged with chemical warfare agents, Sarin (GB) and Sulfur Mustard (HD), using a Simulant Agent Resistant Test Manikin (SMARTMAN) while functioning

  15. Technology Employed to test the LRPL Requirements Laboratory Respirator Protection Level (LRPL) • Quantitative corn-oil, fit-factor test using human test subjects

  16. CBRN Respirator Standards CBRN Standards Completed by Policy • Open Circuit SCBA – January 2002 • Open Circuit SCBA Upgrades – March 2003 • Air Purifying Respirator / Gas Mask – March 2003 • Air Purifying Escape Respirator – October 2003 • Self Contained Escape Respirator – October 2003 • Powered Air Purifying Respirator – October 2006 CBRN Standards in Development Under Rulemaking • Supplied Air Respirator • Closed-Circuit SCBA • Combination SCBA/PAPR or SCBA/APR

  17. What’s Next? • Increase national inventory of respirators by testing and evaluating CBRN respirators when applications are submitted to NIOSH • Continue to increase capacity for testing (e.g. LRPL, LAT) • Develop CBRN standards for supplied air respirators, closed circuit SCBA and combination units via rulemaking • Continue involvement with national and international SDOs (NFPA, Canadian Standards, BSI, ISO, etc.) • Develop CBRN guidance documents • NIOSH-NPPTL is Participating with NIJ on the CBRN Ensemble Standard Special Technical Committeeto address PPE needs of Law Enforcement • NPPTL will continue with PPT research related to Respiratory Protection, Human Performance, Sensors and Ensembles

  18. Quality Partnerships Enhance Worker Safety & Health Visit Us at: http://www.cdc.gov/niosh/npptl/default.html Disclaimer:The findings and conclusions in this presentation have not been formally disseminated by the National Institute for Occupational Safety and Health and should not be construed to represent any agency determination or policy.

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