respiratory protection for the first responder community through research, standards development and certification

1. Respiratory Protection for the First Responder Community Through Research, Standards Development and Certification

3. NIOSH�s parent department is the Department of Health and Human Services NIOSH is an Institute under the Centers for Disease Control and Prevention And NPPTL is one of the Divisions in NIOSHNIOSH�s parent department is the Department of Health and Human Services NIOSH is an Institute under the Centers for Disease Control and Prevention And NPPTL is one of the Divisions in NIOSH

4. 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 NIOSH NIOSH consists of 13 Divisions and laboratories; NPPTL is one of the laboratories Located in Pittsburgh, PA. The NPPTL was officially established in July 2001 NIOSH consists of 13 Divisions and laboratories; NPPTL is one of the laboratories Located in Pittsburgh, PA. The NPPTL was officially established in July 2001

5. 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. 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). 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).

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 NIOSH Authority OSHA requires that respirators be NIOSH approved All NIOSH CBRN Respiratory Protective Device Standards to date were developed by Policy Future standards will be developed by using the Rulemaking process. 42 CFR is the overall respiratory approval regulation � very specific, change process is lengthy NIOSH Authority OSHA requires that respirators be NIOSH approved All NIOSH CBRN Respiratory Protective Device Standards to date were developed by Policy Future standards will be developed by using the Rulemaking process. 42 CFR is the overall respiratory approval regulation � very specific, change process is lengthy

7. Respirator Certification consists of application processing, respirator testing, QA evaluation and Post Certification activities More than 8,500 NIOSH approvals issued since 1972 84 approval holders 102 manufacturing sites 17 countries As of Oct 2007 the following approvals were Issued: 69 CBRN Open Circuit SCBA approvals and 19 approvals for retrofit kits 9 CBRN Air Purifying Respirators 5 CBRN Air Purifying Escape Respirators 2 CBRN Loose Fitting Powered Air-Purifying Respirators 1 CBRN Tight Fitting Powered Air-Purifying Respirators NIOSH Post Certification activities include purchasing approved new respirators and fielded items for follow-up tests to ensure they are in compliance with NIOSH standards. NIOSH QA personnel try to visit manufacturer sites at least once every two years. Respirator Certification consists of application processing, respirator testing, QA evaluation and Post Certification activities More than 8,500 NIOSH approvals issued since 1972 84 approval holders 102 manufacturing sites 17 countries As of Oct 2007 the following approvals were Issued: 69 CBRN Open Circuit SCBA approvals and 19 approvals for retrofit kits 9 CBRN Air Purifying Respirators 5 CBRN Air Purifying Escape Respirators 2 CBRN Loose Fitting Powered Air-Purifying Respirators 1 CBRN Tight Fitting Powered Air-Purifying Respirators NIOSH Post Certification activities include purchasing approved new respirators and fielded items for follow-up tests to ensure they are in compliance with NIOSH standards. NIOSH QA personnel try to visit manufacturer sites at least once every two years.

8. NIOSH-NPPTL personnel not only use 42 CFR Part 84 But actively participate on and support other Standards Developing Organizations such ANSI, ISO, NFPA and ASTM to develop consensus PPT standards SDOs committees are formed by a balance representation of personnel with the diverse background from Labor, User Community Academia, Government and Subject Matter experts NIOSH-NPPTL personnel not only use 42 CFR Part 84 But actively participate on and support other Standards Developing Organizations such ANSI, ISO, NFPA and ASTM to develop consensus PPT standards SDOs committees are formed by a balance representation of personnel with the diverse background from Labor, User Community Academia, Government and Subject Matter experts

9. 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 CBRN Standards Development One of the initial meetings held to address the respiratory protective needs of the first responder community was the NIOSH-DOD-OSHA Chemical-Biological Respiratory Workshop & Report (March 1999) This meeting lead to Inter Agency Agreements between with NIST and DOD�s RDECOM The Initial and continuing funding from was NIST-NIJ/NIST-DHS/CDC to NIOSH and RDECOM Memorandum of Understanding was made with RDECOM for their technical support and testing capabilities One of the initial meetings held to address the respiratory protective needs of the first responder community was the NIOSH-DOD-OSHA Chemical-Biological Respiratory Workshop & Report (March 1999) This meeting lead to Inter Agency Agreements between with NIST and DOD�s RDECOM The Initial and continuing funding from was NIST-NIJ/NIST-DHS/CDC to NIOSH and RDECOM Memorandum of Understanding was made with RDECOM for their technical support and testing capabilities

10. There was a Sequential process taken to developing the CBRN respirator standards. Hazard analysis which estimated the hazard and concentrations of the hazard in various scenarios Protection determinations (what needs to be protected) Human and environmental factors ( performance features that effect the limit human performance such as Field of view, communication, fogging resistance Standards concept paper were developed followed by Public Meetings Test requirements benchmarked Development of Standard Test Procedure (STP) development, testing, and methodology validation There was a Sequential process taken to developing the CBRN respirator standards. Hazard analysis which estimated the hazard and concentrations of the hazard in various scenarios Protection determinations (what needs to be protected) Human and environmental factors ( performance features that effect the limit human performance such as Field of view, communication, fogging resistance Standards concept paper were developed followed by Public Meetings Test requirements benchmarked Development of Standard Test Procedure (STP) development, testing, and methodology validation

11. At a CBRN event that hazards are not characterized: the hazard and concentration of the hazard Potential Hazards include Chemical, Biological, Radiological and Nuclear (CBRN) materials: Chemicals include Toxic Industrial Chemical (TICs) and Traditional Military Chemical Warfare Agents (CWA) At a CBRN event that hazards are not characterized: the hazard and concentration of the hazard Potential Hazards include Chemical, Biological, Radiological and Nuclear (CBRN) materials: Chemicals include Toxic Industrial Chemical (TICs) and Traditional Military Chemical Warfare Agents (CWA)

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.

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 The respirator is operating in a dynamic mode during this agent permeation resistance test.The respirator is operating in a dynamic mode during this agent permeation resistance test.

15. Technology Employed to test the LRPL Requirements Laboratory Respirator Protection Level (LRPL) Quantitative corn-oil, fit-factor test using human test subjects The LRPL measure the ratio of the concentration of corn-oil particles inside the facepiece to the concentration in the Challenge Chamber. It measures the ability of a particular respirator to fit to a panel of different facial sizes. The LRPL measure the ratio of the concentration of corn-oil particles inside the facepiece to the concentration in the Challenge Chamber. It measures the ability of a particular respirator to fit to a panel of different facial sizes.

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 Committee to address PPE needs of Law Enforcement NPPTL will continue with PPT research related to Respiratory Protection, Human Performance, Sensors and Ensembles NIOSH will Address the respiratory protection issues of all the various First Responder/Receiver Community during Rulemaking such as the Medical and Law Enforcement Communities. . NIOSH will Address the respiratory protection issues of all the various First Responder/Receiver Community during Rulemaking such as the Medical and Law Enforcement Communities. .

18. Quality Partnerships Enhance Worker Safety & Health Thank You.. This concludes my presentation. I address any questions at this time. Thank You.. This concludes my presentation. I address any questions at this time.