CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES

IMPROVING WORKER SAFETY

Committee on the Certification of Personal Protective Technologies

Board on Health Sciences Policy

Howard J. Cohen and Catharyn T. Liverman, Editors

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES IMPROVING WORKER SAFETY Committee on the Certification of Personal Protective Technologies Board on Health Sciences Policy Howard J. Cohen and Catharyn T. Liverman, Editors

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, N.W. • 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. 200-2005-10881, T.O. #9, 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: 978-0-309-15855-8 International Standard Book Number-10: 0-309-15855-9 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 2011 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Cover credit: Photo of firefighters reprinted with permission from MSA – The Safety Company. Suggested Citation: IOM (Institute of Medicine). 2011. Certifying personal protective technologies: Improving worker safety. 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 government 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 associate 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 ON THE CERTIFICATION OF PERSONAL PROTECTIVE TECHNOLOGIES HOWARD J. COHEN (Chair), Professor of Occupational Safety and Health, Emeritus, University of New Haven ROGER L. BARKER, Professor, North Carolina State University JANICE COMER BRADLEY, Executive Vice President, Waste Equipment Technology Association, Washington, DC BARBARA J. BURGEL, Clinical Professor of Occupational and Environmental Health Nursing, University of California, San Francisco MICHAEL EASTERBROOK, Professor of Ophthalmology, University of Toronto CHRISTINA EGAN, Director, Biodefense Laboratory, Wadsworth Center, New York State Department of Health, Albany ALEXANDER ISAKOV, Executive Director, Office of Critical Event Preparedness and Response, Emory University, Atlanta, Georgia SUNDARESAN JAYARAMAN, Professor, Georgia Institute of Technology, Atlanta JAMES S. JOHNSON, Consultant, JSJ and Associates, Pleasanton, California MELISSA A. MCDIARMID, Director, Occupational Health Program, University of Maryland JAMES W. PLATNER, Associate Director, CPWR–Center for Construction Research and Training, Silver Spring, Maryland ANUGRAH SHAW, Professor, University of Maryland–Eastern Shore TANYA WANCHEK, Health Economist, Center for Economic and Policy Studies, University of Virginia, Charlottesville SAMUEL E. WEHR, Consultant in Survival and Flotation Technology, Standards and Regulations Manager, Mustang Survival Corporation, Woodbridge, Virginia Study Staff CATHARYN T. LIVERMAN, Study Director ANDREW M. POPE, Board on Health Sciences Policy Director SARAH L. HANSON, Associate Program Officer (through July 2010) JUDITH L. ESTEP, Program Associate v

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved 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 pub- lished report as sound as possible and to ensure that the report meets in- stitutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confi- dential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Jacqueline Agnew, Johns Hopkins University Bloomberg School of Public Health Paul Citron, Medtronic, Inc. (Retired) Richard M. Duffy, International Association of Fire Fighters Patricia A. Gleason, Safety Equipment Institute Jimmy Perkins, University of Texas Health Science Center Daniel K. Shipp, International Safety Equipment Association Debra Stoe, Department of Justice Jeffrey O. Stull, International Personnel Protection, Inc. Paul F. Vinger, Lexington Eye Associates Sharon Welbel, John H. Stroger Jr. Hospital Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by vii

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viii REVIEWERS Richard Merrill, University of Virginia, and Edward B. Perrin, Uni- versity of Washington. 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 careful- ly considered. Responsibility for the final content of this report rests en- tirely with the authoring committee and the institution.

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Preface Conformity assessment is key to ensuring that the products we pur- chase are effective and perform to specifications; as users we are not ex- pected to know or be engaged in the actual intricacies of how products are tested and verified to make sure that they meet performance require- ments. This report focuses on conformity assessment for occupational personal protective technologies (PPT)—ensuring that PPT are effective in preventing or reducing hazardous exposures or situations that workers face in their jobs. Because respirators already have an extensive testing and conformity assessment process in place, the charge to this committee was to address conformity assessment processes for other types of PPT, including eye and face protection, gloves, hearing protectors, and protec- tive clothing. The impetus for this study comes from the recommendations of a 2009 Institute of Medicine and National Research Council report that reviewed the PPT Program at the National Institute for Occupational Safety and Health (NIOSH). The report identified gaps and inconsisten- cies in the certification and other conformity assessment processes for non-respirator PPT and urged that this issue be further explored. As the committee surveyed the current state of conformity assess- ment for PPT products, it became evident that a number of varied ap- proaches are currently in place with the involvement of multiple organizations and federal agencies. Processes differed in the rigor of the testing, the extent of independent third-party involvement in the process, requirements for quality manufacturing processes, and follow-up efforts to identify post-marketing concerns. The need for a greater emphasis on a consistent and risk-based approach to PPT conformity assessment was identified as a priority by the committee. In workplaces where there are ix

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x PREFACE greater risks to the health and safety of the worker if the PPT product does not perform effectively, increased levels of involvement and re- quirements for independent third-party testing and certification are deemed appropriate. The NIOSH National Personal Protective Technology Laboratory (NPPTL) has a unique role to play as the nation’s focal point for occupa- tional PPT. NPPTL staff’s depth of expertise is being used effectively in respirator testing and certification and in standards development efforts for non-respirator PPT. This expertise can be leveraged by increased col- laborations with other federal agencies and organizations to enhance PPT conformity assessment efforts and by NPPTL serving as a central reposi- tory for research and dissemination of PPT conformity assessment in- formation. In exploring conformity assessment processes and the standards be- hind them, the committee had the opportunity to engage in discussions with a number of dedicated professionals in government agencies and in the private sector who work to develop and improve product standards and conformity assessment processes. The committee learned a great deal from its April 2010 workshop and in other conversations and greatly appreciates the time and effort that the workshop presenters, study spon- sors, and many others provided in informing this study. This report reflects the hard work and careful considerations of a dedicated committee. I want to thank each committee member and the IOM staff members for working first to get a handle on this complex top- ic and then to carefully consider and discuss the many facets of this is- sue. The committee hopes this report will be a step forward in improving worker safety and health by ensuring consistent and rigorous testing of PPT products, thorough verification that products meet the performance criteria, and transparent and widespread dissemination of information on certified products. Howard J. Cohen, Chair Committee on the Certification of Personal Protective Technologies

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Contents ACRONYMS xiii SUMMARY 1 1 INTRODUCTION 15 Scope of This Report, 16 Personal Protective Technologies, 18 Basics of Conformity Assessment, 19 Why Certify? Why Conform?, 20 Relevant Agencies and Organizations, 28 Overview of This Report, 29 References, 30 2 ROLE OF GOVERNMENT AGENCIES IN CONFORMITY ASSESSMENT 33 Standards Development, 34 Product Testing, 39 Accreditation of Laboratories and Certifying Organizations, 41 Declaration of Conformity and Certification, 43 Communication: Certification Marks and Labels, 45 Incentives and Enforcement, 47 Surveillance and Post-Marketing Testing and Evaluation, 48 Other Government Roles, 51 References, 52 3 CURRENT PPT CONFORMITY ASSESSMENT PROCESSES 55 Respirator Certification, 56 Healthcare Worker PPT, 60 xi

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xii CONTENTS Firefighter and Emergency Responder PPT, 65 Ballistic-Resistant Body Armor, 69 Hearing Protection Devices, 73 Personal Flotation Devices, 75 Protective Clothing for Pesticide Operators, 79 Other PPT, 80 PPE Conformity Assessment in the European Union, 82 Summary, 84 References, 84 4 IMPACT AND ISSUES IN CONFORMITY ASSESSMENT FOR PPT 89 Impact of Conformity Assessment on Safety and Health, 90 Conformity Assessment Issues for PPT, 94 References, 102 5 CONFORMITY ASSESSMENT FOR NON-RESPIRATOR PPT: A RISK-BASED FRAMEWORK 105 Guiding Principles for Conformity Assessment, 105 A Tiered Approach to PPT Conformity Assessment, 109 References, 113 6 FINDINGS AND RECOMMENDATIONS 115 A Comprehensive Risk-Based Framework for PPT Conformity Assessment, 115 Research, Surveillance, and Communication, 119 7 TOWARD A COMPREHENSIVE APPROACH TO SAFE AND EFFECTIVE PPT FOR WORKERS 125 Reference, 126 APPENDIXES A Agendas of Public Meetings 127 B Workshop Participants 137 C Biographical Sketches of Committee Members 143

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Acronyms AAMI Association for the Advancement of Medical Instrumentation AIHA American Industrial Hygiene Association ANSI American National Standards Institute ASSE American Society of Safety Engineers ASTM originally, the American Society for Testing and Materials, now ASTM International BVP Bulletproof Vest Partnership CBRN chemical, biological, radiological, and nuclear CDC Centers for Disease Control and Prevention CEL Certified Equipment List CFR Code of Federal Regulations CPSC Consumer Product Safety Commission CSA Canadian Standards Association DHS Department of Homeland Security DoD Department of Defense DOJ Department of Justice DOL Department of Labor EC European Commission EEC European Economic Community EPA Environmental Protection Agency EU European Union xiii

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xiv ACRONYMS FAR Federal Acquisition Regulations FDA Food and Drug Administration FFFIPP Fire Fighter Fatality Investigation and Prevention Program GAO Government Accountability Office (prior to 2004, General Accounting Office) HECC Hockey Equipment Certification Council HEROES Homeland Emergency Response Operational and Equipment Systems HHE Health Hazard Evaluation HHS U.S. Department of Health and Human Services IAB InterAgency Board for Equipment Standardization and Interoperability IAFF International Association of Fire Fighters IEC International Electrotechnical Commission IOM Institute of Medicine ISEA International Safety Equipment Association ISO International Organization for Standardization MAUDE Manufacturer and User Device Experience MedSun FDA Medical Product Safety Network MedWatch FDA Safety Information and Adverse Event Reporting Program MSHA Mine Safety and Health Administration NCSCI National Center for Standards and Certification Information NEISS National Electronic Injury Surveillance System NFPA National Fire Protection Association NIJ National Institute of Justice NIOSH National Institute for Occupational Safety and Health NIST National Institute of Standards and Technology NLECTC National Law Enforcement and Corrections Technology Center NORA National Occupational Research Agenda NPPTL National Personal Protective Technology Laboratory NRC National Research Council

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xv ACRONYMS NRR noise reduction rating NRTL Nationally Recognized Testing Laboratories NTTAA National Technology Transfer and Advancement Act NVFC National Volunteer Fire Council NVLAP National Voluntary Laboratory Accreditation Program OMB Office of Management and Budget OSHA Occupational Safety and Health Administration PFD personal flotation device PMA premarket approval application PPE personal protective equipment PPT personal protective technologies QA quality assurance SCBA self-contained breathing apparatus SCSR self-contained self-rescuer (respirator) SEI Safety Equipment Institute SENSOR Sentinel Event Notification System for Occupational Risks UL Underwriters Laboratories USBM U.S. Bureau of Mines USCG U.S. Coast Guard USDA U.S. Department of Agriculture

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