frank palya

Respiratory Protection for the First Responder Community Through Research, Standards

Development and Certification

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

2005 October 26 PSD RBA

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?

HHSHHS

CDCCDC

NIOSHNIOSH

NPPTLNPPTL

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health

National Personal Protective Technology Laboratory

NPPTL: Federal Agency Hierarchy

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

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).

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

2005 October 16 PSD TC

Respirator Certification

Respirator certification

Application processing

Respirator testing and QA Plan evaluation

Post certification

Product and site audits

Respirator equipment evaluations

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

Personal Protective Technology Standards Participation

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

2005 October 16 RES HA

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

Research to Development of CBRN Standards

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

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.


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


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


Technology Employed to test the LRPL Requirements

Laboratory Respirator Protection Level (LRPL)

Quantitative corn-oil, fit-factor test using human test subjects


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


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


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.

frank palya

Documents