The Personal Protective Technology Program at NIOSH

Reviews of Research Programs of the National Institute for Occupational Safety and Health

Committee to Review the NIOSH Personal Protective Technology Program

Board on Health Sciences Policy

INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

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The Personal Protective Technology Program at NIOSH Reviews of Research Programs of the National Institute for Occupational Safety and Health Committee to Review the NIOSH Personal Protective Technology Program Board on Health Sciences Policy

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was requested by the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention and supported by Award No. 211-2006-19152, T.O. #1, between the National Academy of Sciences and the Centers for Disease Control and Prevention. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number 13: 978-0-309-12018-0 International Standard Book Number 10: 0-309-12018-7 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Cover credits: Photographs are reprinted with permission courtesy of DuPont and of MSA (Mine Safety Appliances Company). Suggested Citation: Institute of Medicine and National Research Council. 2008. The Personal Protective Technology Program at NIOSH. Committee to Review the NIOSH Personal Protective Technology Program. Rpt. No. 5, Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, DC: The National Academies Press.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal govern- ment on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to as- sociate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE TO REVIEW THE NIOSH PERSONAL PROTECTIVE TECHNOLOGY PROGRAM E. JOHN GALLAGHER (Chair), University Chair, Department of Emergency Medicine, Albert Einstein College of Medicine, New York City ROGER L. BARKER, Professor, Department of Textile Engineering, Chemistry and Science, North Carolina State University, Raleigh HOWARD J. COHEN, Professor of Occupational Safety and Health Management, University of New Haven, CT JANICE COMER-BRADLEY, Technical Director, International Safety Equipment Association, Arlington, VA ELIZABETH A. CORLEY, Assistant Professor, School of Public Affairs, Arizona State University, Phoenix RICHARD M. DUFFY, Assistant to the General President, International Association of Fire Fighters, Washington, DC JAMES S. JOHNSON, Consultant, JSJ and Associates, Pleasanton, CA JAMES M. MCCULLOUGH,1 Senior Researcher, SRI International, Arlington, VA JIMMY PERKINS, Professor, Environmental and Occupational Health, University of Texas School of Public Health, San Antonio DAVID PREZANT, Chief Medical Officer, Office of Medical Affairs, New York City Fire Department; Professor of Medicine, Albert Einstein College of Medicine, New York City KNUT RINGEN, Independent Consultant, Seattle, WA EMANUEL P. RIVERS, Director of Research, Emergency Department, Henry Ford Hospital, Detroit, MI JOSEPH J. SCHWERHA, Professor and Director of the Occupational and Environmental Medicine Residency and the Disaster Preparedness Certificate Program, University of Pittsburgh, PA ANUGRAH SHAW, Professor, Department of Human Ecology, University of Maryland Eastern Shore, Princess Anne TONYA SMITH-JACKSON, Associate Professor of Human Factors Engineering, Department of Industrial and Systems Engineering, Virginia Polytechnic Institute and State University, Blacksburg Framework Committee Liaison SUSAN E. COZZENS, Director, Technology Policy and Assessment Center, Georgia Institute of Technology, Atlanta 1 Resigned from committee effective November 12, 2007. v

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Board on Health Sciences Policy Liaison MARTHA HILL, Dean and Professor of Nursing, Johns Hopkins University, Baltimore, MD Project Staff CATHY LIVERMAN, Study Director TOM PLEWES, Senior Program Officer ERICKA MCGOWAN, Associate Program Officer JUDY ESTEP, Program Associate vi

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Independent Report Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures ap- proved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Jacqueline Agnew, Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health Don B. Chaffin, Industrial and Operations Engineering and Biomedical Engineering, University of Michigan Sarah Felknor, Southwest Center for Occupational and Environmental Health, University of Texas School of Public Health Robert A. Freese, Globe Manufacturing Company Zane Frund, Chemical Research and Analytical Services, Mine Safety Appliances Company Stephan Graham, Industrial Hygiene Field Services Program, Directorate of Occupational Health Sciences, U.S. Army Center for Health Promotion and Preventive Medicine vii

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Independent RepoRt RevIeweRs viii Sundaresan Jayaraman, School of Polymer, Textile and Fiber Engineering and College of Management, Georgia Institute of Technology Jeffery Kravitz, Scientific Development, Mine Safety and Health Administration Fred A. Mettler, Radiology and Nuclear Medicine, New Mexico Veterans Health Care System James W. Platner, CPWR: The Center for Construction Research and Training Lewis J. Radonovich, Project BREATHE, and Biosecurity Programs, Office of Program Development, North Florida/South Georgia Veterans Health System Kenneth D. Rosenman, Division of Occupational and Environmental Medicine, Michigan State University John A. Schaefer, Health, Safety and Environment Department, Johns Hopkins University School of Medicine Bruce Tatarchuk, Center for Microfibrous Materials Manufacturing, Department of Chemical Engineering, Auburn University Although the reviewers listed above have provided many constructive com- ments and suggestions, they were not asked to endorse the conclusions or rec- ommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Paul D. Stolley, University of Maryland School of Medicine, and Kristine M. Gebbie, Columbia University School of Nurs- ing. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface A firefighter wearing turn-out gear to avoid burn injury and using a self- contained breathing apparatus to prevent inhalation of smoke and other toxic atmospheres; an emergency responder in an encapsulated suit to protect against chemical, biological, and nuclear threats; or a healthcare pro- vider wearing gloves, gown, and a respirator to reduce transmission of infectious diseases—these examples are prototypic of the millions of workers in a wide array of occupations who depend on personal protective technologies (PPT) for their health and safety every day. This report provides a critical appraisal of selected features of the Personal Protective Technology Program of the National Institute for Occupational Safety and Health (NIOSH). The committee was asked to evaluate the relevance and im- pact of a dozen specific elements of the PPT Program in preventing work-related injury and illness, identify important future considerations for scientific investiga- tion, and provide recommendations for program improvement. Consistent with the committee’s charge from NIOSH, we focused on eight components of respira- tory protection, three components of dermal protection, and a single component of injury prevention. Where relevant, we evaluated these efforts across the three domains of research, certification, and standards setting. In conducting this study, the committee noted the significant progress that has been made in developing and testing respirators to reduce or prevent hazardous ix

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pReface x inhalation exposures, currently limited mainly by the problems of facial fit and user adherence. Concurrently the committee identified important challenges ahead in ensuring that other types of non-respiratory PPT (e.g., protective clothing, gloves, eyewear, hearing protection, helmets, and fall harnesses) receive similar attention in their testing and development. Furthermore, there are many substantive scientific and regulatory challenges in providing workers with integrated PPT that offers multiple types of necessary protection. These challenges arise because few PPT products are designed to work together in a seamless and coordinated fashion, thus causing gaps in protection where different components interface, compromising worker health and safety. In addition, PPT may be uncomfortable and may impede communication or the ability to perform one’s job. Thus, as explored in detail in the report, there are a wealth of opportunities for improving PPT to better protect U.S. workers. The impetus for a national focus on PPT gained momentum with a congres- sional mandate from which the National Personal Protective Technology Labora- tory was created in 2001. However, the mandate was not accompanied by sufficient resources to fully implement a PPT program that could lead efforts to meet the many and varied PPT needs across all relevant occupations. The committee ex- amined the progress the PPT Program has made in the face of limited resources, and urges implementation of our recommendations to move the entirety of this critically important area of endeavor forward. It was a privilege to chair this committee. Truly an interdisciplinary group, its strength was in the extensive expertise, thoughtful intelligence, dedicated efforts, and unfailing good nature of its members. The committee worked diligently to provide a fair scoring of the PPT Program’s relevance and impact upon worker safety and health. But rating scales have inherent limitations and it is in going beyond the scores to the narrative component of this report, particularly the five recommendations, where the committee hopes it can make a contribution to the already substantial efforts of the PPT Program. The committee greatly benefited from the thorough briefings and informa- tive discussions with staff members of the NIOSH PPT Program. On behalf of the committee, I want to thank Les Boord, Maryann D’Alessandro, Roland Berry Ann, Ron Shaffer, Heinz Ahlers, Jon Szalajda, Bill Haskell, Ray Sinclair, and the many other NIOSH staff who provided a wealth of information to the committee and were exceedingly patient with our sometimes insistent queries and frequent requests for clarification. I would also like to acknowledge the extraordinary contributions made to this report by the IOM and NRC staff, specifically Cathy Liverman, Tom Plewes, Ericka McGowan, and Judy Estep.

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pReface xi Efforts to improve the safety and health of workers in the United States and around the world are vitally important. It is the committee’s hope that this report can help move those efforts another step forward. E. John Gallagher, Chair Committee to Review the NIOSH Personal Protective Technology Program

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Contents ABBREVIATIONS AND ACRONYMS xvii SUMMARY 1 1 INTRODUCTION 19 Scope of This Report, 20 Context and Background, 21 Overview of the NIOSH PPT Program, 24 Evaluation Approach, 30 Overview of This Report, 33 References, 33 2 RELEVANCE OF THE NIOSH PPT PROGRAM 34 Overview of PPT Program Resources, 35 Goal 1: Reduce Exposures to Inhalation Hazards, 41 Goals 2 and 3: Reduce Exposures to Dermal and Injury Hazards, 63 Surveillance, 71 Overall Assessment of Relevance, 74 References, 76 3 IMPACT OF THE NIOSH PPT PROGRAM 81 External Factors, 82 xiii

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contents xiv End Outcomes, 83 Intermediate Outcomes, 84 Overall Assessment of Impact, 97 References, 99 4 EMERGING ISSUES AND RESEARCH AREAS IN PERSONAL 101 PROTECTIVE TECHNOLOGY PPT Program’s Process for Identifying Emerging Issues, 101 Committee’s Assessment of the PPT Program’s Process, 103 Emerging Issues Identified by the Committee, 104 References, 114 5 RECOMMENDATIONS FOR PPT PROGRAM IMPROVEMENT 116 Implement and Sustain a Comprehensive National PPT Program, 117 Establish PPT Research Centers of Excellence, 120 Enhance the Respirator Certification Process, 122 Increase Research on the Use and Usability of PPT, 125 Assess PPT Use and Effectiveness in the Workplace, 126 Concluding Remarks, 128 References, 129 APPENDIXES A Framework for the Review of Research Programs of the 131 National Institute for Occupational Safety and Health B Methods: Committee Information Gathering 176 C Information Provided by the NIOSH PPT Program 185 D Biographical Sketches of Committee Members 187

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Tables, Figures, and Boxes TABLES 2-1 PPT Overall Budget Summary, 36 2-2 Breakdown of the PPT Program Budget by Objective, 38 2-3 Staff Allocations (FTE) by PPT Program Objectives, 39 2-4 Ongoing NIOSH Extramural Grants with a PPT Component, 41 2-5 Manufacturers’ Respirator Certification Fees Retained by NIOSH, 43 2-6 Product Investigations, Including FFFIPP Investigations, 47 2-7 Number of Respirator Certifications by Category and Calendar Year, 48 2-8 Funding for NIOSH PPT Policy and Standards Development, 50 2-9 Steps in the Federal Rule-Making Process for Changes to 42 CFR 84, 52 2-10 Status of Federal Regulatory Changes (as of March 2008), 54 3-1 Recent Consensus Standards with PPT Program Involvement, 93 FIGURES 1-1 PPT-relevant efforts within the NIOSH organizational structure, 28 1-2 Logic model for the NIOSH Personal Protective Technology Program, 31 2-1 PPT Program funding by year and source, 35 2-2 PPT Program budget FY 2001-2007, 37 xv

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tables, fIguRes, boxes and xvi 2-3 Funding sources for respirator certification by fiscal year, 42 2-4 Percentage of respirator certification applications processed within 90 days, 45 BOXES S-1 PPT Program Strategic Goals and Objectives, 4 S-2 Scoring Criteria for Relevance, 7 S-3 Scoring Criteria for Impact, 9 S-4 Summary of Report Recommendations, 11 1-1 PPT Program Strategic Goals and Objectives, 26 1-2 NIOSH PPT Objectives Not Considered as Part of This Review, 27 1-3 Logic Model Terms and Examples, 32 2-1 NIOSH-Sponsored PPT Meetings, 51 2-2 Timeline of Key Events for the Dermal PPT Program—Inputs, Activities, and Outputs, 65 2-3 Scoring Criteria for Relevance, 76 3-1 Scoring Criteria for Impact, 98

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Abbreviations and Acronyms AIHA American Industrial Hygiene Association ANSI American National Standards Institute APR air-purifying respirator ASTM originally, the American Society for Testing and Materials, now ASTM International BLS Bureau of Labor Statistics CBRN chemical, biological, radiological, and nuclear CCSCBA closed-circuit self-contained breathing apparatus CDC Centers for Disease Control and Prevention CEL Certified Equipment List CFR Code of Federal Regulations COPPE Committee on Personal Protective Equipment CPIP Certified Product Investigation Process DHHS Department of Health and Human Services DHS Department of Homeland Security DoD Department of Defense DoL Department of Labor DRDS Division of Respiratory Disease Studies (NIOSH) xvii

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a b b R e v I at I o n s acRonyms and xviii EPA Environmental Protection Agency ERC Education and Research Center (NIOSH) ESLI end-of-service-life indicator FDA Food and Drug Administration FEV forced expiratory volume FFFIPP Fire Fighter Fatality Investigation and Prevention Program FTE full-time equivalent FVC forced vital capacity HEROES Homeland Emergency Response Operational and Equipment Systems HHE Health Hazard Evaluation IAB InterAgency Board for Equipment Standardization and Interoperability IAFF International Association of Fire Fighters IOM Institute of Medicine ISO International Organization for Standardization LTFE Long-Term Field Evaluation MINER Act Mine Improvement and New Emergency Response Act of 2006 MOU memorandum of understanding MSHA Mine Safety and Health Administration NFPA National Fire Protection Association NIOSH National Institute for Occupational Safety and Health NIST National Institute of Standards and Technology NORA National Occupational Research Agenda NPPTL National Personal Protective Technology Laboratory NRC National Research Council OMB Office of Management and Budget OSHA Occupational Safety and Health Administration PAPR powered air-purifying respirator PASS personal alert safety system PPE personal protective equipment PPT personal protective technology/technologies

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a b b R e v I at I o n s acRonyms and xix r2p research to practice RKB Responder Knowledge Base SARS severe acute respiratory syndrome SCBA self-contained breathing apparatus SCSR self-contained self-rescuer (respirator) SEI Safety Equipment Institute SRUP Survey of Respirator Use and Practices TIL total inward leakage TSWG Technical Support Working Group UL Underwriters Laboratories USDA U.S. Department of Agriculture

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