Respiratory Diseases Research at NIOSH

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

Committee to Review the NIOSH Respiratory Diseases Research Program

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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Respiratory Diseases Research at NIOSH Reviews of Research Programs of the National Institute for Occupational Safety and Health Committee to Review the NIOSH Respiratory Diseases Research Program Board on Environmental Studies and Toxicology Division on Earth and Life Studies

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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 project was supported by Contract No. 211-2006-19152 between the National Academy of Sciences and the National Institute for Occupational Safety and Health. 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: 978-0-309-11873-6 International Standard Book Number-10: 0-309-11873-5 Cover: Photograph by Keith Weller, U.S. Department of Agriculture. The air-curtain orchard sprayer uses multiple crossflow fans to disperse pesticide to apple trees. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Suggested citation: National Research Council and Institute of Medicine. 2008. Respiratory Disesases Research at NIOSH. Committee to Review the NIOSH Respiratory Diseases Research Program. Rpt. No. 4, Reviews of Research Programs of the National Institute for Occupational Safety and Health. Washington, D.C.: 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 RESPIRATORY DISEASES RESEARCH PROGRAM Members MARk UTELL (Chair), University of Rochester, New York JOHN BALMES, University of California, San Francisco PAUL BLANC, University of California, San Francisco ELIzABETH CHAMBERLIN, Massey Coal Services, Chapmanville, WV ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, NM DAVID MANNINO, University of Kentucky, Lexington JAMES MERCHANT, University of Iowa, Iowa City JACqUELINE NOWELL, United Food and Commercial Workers International, Washington, DC CHARLES POOLE, University of North Carolina, Chapel Hill RICHARD SCHLESINGER, Pace University, New York, NY NOAH SEIxAS, University of Washington, Seattle IRA TAGER, University of California, Berkeley DAVID WEGMAN, University of Massachusetts, Lowell Staff k. JOHN HOLMES, Senior Program Officer kARL E. GUSTAVSON, Senior Program Officer DAVID J. POLICANSkY, Scholar RUTH E. CROSSGROVE, Senior Editor CAY BUTLER, Editor Mirsada Karalic-loncarevic, Manager, Technical Information Center JORDAN CRAGO, Senior Project Assistant MORGAN R. MOTTO, Senior Program Assistant RADIAH A. ROSE, Senior Editorial Assistant Sponsor NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH v

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Preface The National Institute for Occupational Safety and Health (NIOSH) was estab- lished by the Occupational Safety and Health Act of 1970 to “conduct . . . research, experiments, and demonstrations relating to occupational safety and health” and to develop “innovative methods, techniques, and approaches for dealing with [those] problems.” One component of these activities is the Respiratory Diseases Research Program, whose stated mission is “to provide national and international leadership for the prevention of work-related respiratory diseases, using a scientific approach to gather and synthesize information, create knowledge, provide recommendations, and deliver products and services to those who can effect prevention.” Work-related respiratory diseases are a serious problem of major magnitude. NIOSH indicates that deaths from work-related respiratory disease and malignancies account for about 70 percent of all occupational disease mortality. In this report, the Committee to Review the NIOSH Respiratory Diseases Research Program evaluates NIOSH’s Respiratory Diseases Research Program (RDRP). Using a framework developed by the NRC Committee to Review the NIOSH Research Program, this committee focused primarily on the last 10 years of RDRP activities to review the relevance and impact of RDRP’s research portfolio. In its evaluation the committee also discusses and makes recommendations for upcoming research areas and challenges to be addressed by RDRP. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by vii

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Preface viii the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in mak- ing its published report as sound as possible and to ensure that the report meets institutional standards of 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 for their review of this report: Lisa Brosseau, University of Minnesota; William Bunn III, International Truck & Engine Corporation; David Christiani, Harvard School of Public Health; Ellen Eisen, Harvard School of Public Health; Terry Gordon, New York University; Joel Kaufman, University of Washington; Franklin Mirer, Hunter College of the City University of New York; Roger McCarthy, Exponent, Inc.; Gunter Oberdorster, University of Rochester School of Medicine and Dentistry; Lorann Stallones, Colorado State University; and James Weeks, Advanced Tech- nologies and Laboratories International, Inc. 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 the review coordinator Frank Speizer, Harvard Medical School, and the review monitor, Mark Cullen, Yale University School of Medicine. Appointed by the NRC, they were responsible for making certain that an independent examination of this report was carried out in accor- dance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the committee and the institution. The committee gratefully acknowledges the following for making presenta- tions to the committee: Michael Attfield, Vincent Castranova, Paul Henneberger, Kathleen Kreiss, Jacek Mazurek, Paul Schulte, Lewis Wade, David Weissman, and Ainsley Weston, National Institute for Occupational Safety and Health; Jim Cooper, Synthetic Organic Chemical Manufacturers Association; David Duebner, Brush Inc.; Amanda Edens and William Perry, Occupational Safety and Health Admin- istration; Franklin E. Mirer, Hunter College; George Niewiadomski, Mine Safety and Health Administration; James Weeks, Advanced Technologies and Laboratories International, Inc. The committee also thanks Raymond Sinclair, National Institute for Occupational Safety and Health, for serving as the liaison to the committee and for his outstanding service and professionalism. The committee is also grateful for the assistance of the NRC staff in prepar- ing this report. Staff members who contributed to this effort are K. John Holmes, Karl Gustavson, and David Policansky, study directors; James Reisa, director of the

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Preface ix Board on Environmental Studies and Toxicology; Ruth Crossgrove and Cay Butler, editors; Mirsada Karalic-Loncarevic, research associate; and Morgan Motto, senior project assistant. I would especially like to thank the committee for their efforts throughout the development of this report. Mark J. Utell, Chair Committee to Review the NIOSH Respiratory Diseases Research Program

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Contents SUMMARY 1 1 INTRODUCTION 15 Overview of the Respiratory Diseases Research Program, 18 Study Charge and Evaluation Committee, 27 Evaluation Approach, 28 Organization of the Report, 32 2 EVALUATION OF THE RESPIRATORY DISEASES RESEARCH PROGRAM 34 RDRP Goals, Subgoals, and Resources, 35 External Factors Affecting the RDRP, 35 Surveillance, Health Hazard Evaluation and Technical Assistance Program, and Other Input Activities, 39 Introduction to Relevance and Impacts Assessment, 42 Strategic Goal 1: Prevent and Reduce Work-Related Airway Diseases, 43 Strategic Goal 2: Prevent and Reduce Interstitial Lung Diseases, 59 Strategic Goal 3: Prevent and Reduce Work-Related Infectious Respiratory Diseases, 81 Strategic Goal 4: Prevent and Reduce Work-Related Respiratory Malignancies, 97 xi

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contents xii Strategic Goal 5: Prevent Respiratory and Other Diseases Potentially Resulting from Occupational Exposures to Nanomaterials, 109 Overall Assessment of the RDRP Relevance and Impacts, 117 3 EMERGING RESEARCH AND RESEARCH ISSUES 120 Strategic Goal 1: Prevent and Reduce Work-Related Airways Diseases, 120 Strategic Goal 2: Prevent and Reduce Work-Related Interstitial Lung Diseases, 122 Strategic Goal 3: Prevent and Reduce Work-Related Infectious Respiratory Diseases, 125 Strategic Goal 4: Prevent and Reduce Work-Related Respiratory Malignancies, 127 Strategic Goal 5: Prevent Respiratory and Other Diseases Potentially Resulting from Occupational Exposures to Nanomaterials, 128 Cross-Cutting Issues: Continuing and Emerging Issues Cutting Across Multiple Program Goals, 129 4 RECOMMENDATIONS 132 Strategic Goal 1: Prevent and Reduce Work-Related Airway Diseases, 132 Strategic Goal 2: Prevent and Reduce Work-Related Interstitial Lung Diseases, 139 Strategic Goal 3: Prevent and Reduce Work-Related Infectious Respiratory Diseases, 141 Strategic Goal 4: Prevent and Reduce Work-Related Respiratory Malignancies, 143 Strategic Goal 5: Prevent Respiratory and Other Diseases Potentially Resulting from Occupational Exposures to Nanomaterials, 144 Cross-Cutting Issues, 145 Broader Programmatic Goals, 149 REFERENCES 150 APPENDIxES A Framework for the Review of Research Programs of the National Institute for Occupational Safety and Health 173 B Stakeholder Responses: Online Survey 217 C Bibliographic Information for the Committee to Review the NIOSH Respiratory Diseases Research Program 223 D Biographic Information on the Committee to Review the NIOSH Respiratory Diseases Research Program 226

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Tables, Figures, and Boxes TABLES 1-1 Timeline of Administrative Developments Related to NIOSH Respiratory Diseases Research, 19 1-2 NORA Priority Research Areas, 21 1-3 Example of NORA’s Matrix Approach to Coordinating Research, 21 1-4 NORA2 Structure, 22 1-5 NIOSH RDRP Funding by Fiscal Year, 1996-2005, 25 1-6 NIH versus NIOSH Extramural Funding, 26 2-1 Strategic Goals and Subgoals of the NIOSH RDRP, as of February 2007, 36 2-2 NIOSH RDRP Budget and Staffing by Research Goals, 37 2-3 NIOSH Divisions, Laboratories, and Offices Involved in the RDRP, 39 2-4 Summary of Infectious Diseases Program Outputs and Outcomes, 82 A-1 NORA High-priority Research Areas by Category, 181 A-2 Examples of NIOSH Program Research and Transfer Activities, 198 A-3 Examples of a Variety of Scientific Information Outputs, 201 A-4 Evaluation Committee Worksheet to Assess Research Programs and Subprograms, 209 xiii

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tables, figures, boxes and xiv C-1 List of Documents and Other Items Submitted by the NIOSH RDRP to the National Academies Evaluation Committee between October 10, 2006 and May 17, 2007, 224 FIGURES 1-1 NIOSH organization chart, as of October 2006, 16 1-2 RDRP projects throughout NIOSH, 23 1-3 Flow chart for the evaluation of the NIOSH research program, 29 1-4 Logic model for the RDRP, 32 2-1 Proportional Allocation of RDRP Intramural Funds by Goal by Fiscal Year, 38 2-2 Reductions in respirable dust concentrations derived from MSHA compliance data, and prevalence of CWP among participants in the Coal Workers’ Health Surveillance Program, 1970-2005, 67 A-1 The NIOSH operational plan presented as a logic model, 182 A-2 Flow chart for the evaluation of the NIOSH research program, 186 BOxES S-1 Scoring Criteria for NIOSH Program Reviews from Framework Document, 5 S-2 Summary of Recommendations, 13 1-1 Criteria for Rating Relevance, 30 1-2 Criteria for Rating Impact, 31 1-3 Logic Model Terms and Examples, 33 2-1 Scoring Criteria for NIOSH Program Reviews from Framework Document, 118 4-1 Summary of Recommendations, 134 B-1 Letter with Questionnaire, 218

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Abbreviations and Acronyms AIHA American Industrial Hygiene Association ALFORD Appalachian Laboratory for Occupational Respiratory Diseases ALOSH Appalachian Laboratory for Occupational Safety and Health AMT 3-amino-5-mercapto-1,2,4,-triazole AOEC Association of Occupational and Environmental Clinics APR Air Purifying Respirators ASTM American Society for Testing and Materials ATS American Thoracic Society ATSDR Agency for Toxic Substances and Disease Registry BDS Biological Detection Systems BEST Board on Environmental Studies and Toxicology BLS Bureau of Labor Statistics BRDPI Biomedical Research and Development Price Index BRFSS Behavior Risk Factor Surveillance Survey BSC Board of Scientific Counselors CBD Chronic Beryllium Disease CBR Chemical, Biological, and Radiological CBRN Chemical, Biological, Radiological, and Nuclear CDC Centers for Disease Control and Prevention COPD Chronic Obstructive Pulmonary Disease xv

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a b b r e v i at i o n s acronyms and xvi CPWR Center to Protect Workers’ Rights CWP Coal Workers’ Pneumoconiosis CSTE Council of State and Territorial Epidemiologists DART Division of Applied Research and Technology DBBS Division of Biological and Behavioral Science DELS Division of on Earth and Life Sciences DHHS Department of Health and Human Services DOD Department of Defense DOE Department of Energy DOI Department of the Interior DPSE Division of Physical Sciences and Engineering DRDS Division of Respiratory Disease Studies DSHEFS Division of Surveillance, Hazard Evaluations and Field Studies DSR Division of Safety Research EC Evaluation Committee EID Education and Information Division EPA Environmental Protection Agency FBI Federal Bureau of Investigation FC Framework Committee FDA Food and Drug Administration FDNY Fire Department of New York FEMA Federal Emergency Management Agency FEV1 Forced Expiratory Volume in One Second FTE Full-Time Equivalent FVC Forced Vital Capacity HELD Health Effects Laboratory Division HEPA High-Efficiency Particulate Aerosol HETA HHE and Technical Assistance HHE Health Hazard Evaluation HMW High Molecular Weight IARC International Agency for Research on Cancer ILO International Labour Office ILSI International Life Sciences Institute IOM Institute of Medicine ISO International Standards Organization

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a b b r e v i at i o n s acronyms and xvii JEM Job-Exposure Matrix LMW Low Molecular Weight MDI Methylene Diisocyanate MESA Mine Enforcement and Safety Administration MINER Mine Improvement and New Emergency Response MMWR Morbidity and Mortality Weekly Report MOU Memorandum of Understanding MSHA Mine Safety and Health Administration NA National Academies NAS National Academy of Sciences NACOSH National Advisory Committee on Occupational Safety and Health NCEH National Center for Environmental Health NCHS National Center for Health Statistics NCI National Cancer Institute NCID National Center for Infectious Diseases NFPA National Fire Protection Association NHANES National Health and Nutrition Examination Survey NHIS National Health Interview Survey NHLBI National Heart, Lung, and Blood Institute NIEHS National Institute of Environmental Health Sciences NIH National Institutes of Health NIOSH National Institute for Occupational Safety and Health NMAM NIOSH Manual of Analytical Methods NNI National Nanotechnology Initiative NOHSM National Occupational Health Survey of Mining NORA National Occupational Research Agenda NORMS National Occupational Respiratory Mortality System NPPTL National Personal Protective Technology Laboratory NRC National Research Council NSCWP National Study of Coal Workers’ Pneumoconiosis NSET Nanoscale Science, Engineering and Technology Subcommittee NSSPM National Surveillance System of Pneumoconiosis Mortality NSTC National Science and Technology Council NTP National Toxicology Program NTRC Nanotechnology Research Center OHC Office of Health Communications

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a b b r e v i at i o n s acronyms and xviii OMB Office of Management and Budget ORA Office of Regulatory Analysis ORDS Occupational Respiratory Disease Surveillance OSHA Occupational Safety and Health Administration PAPR Powered Air Purifying Respirator PART Program Assessment Rating Tool PCR Polymerase Chain Reaction PEL Permissible Exposure Limit PHS Public Health Service PPE Personal Protective Equipment PRL Pittsburgh Research Laboratory RCF Refractory Ceramic Fibers RDRP Respiratory Diseases Research Program REL Recommended Exposure Limit SARS Severe Acute Respiratory Syndrome SENSOR Sentinel Event Notification System for Occupational Risks SPIROLA Spirometry Longitudinal Data Analysis SRL Spokane Research Laboratory TB Tuberculosis TC Total Carbon TDI Toluene Diisocyanate TIL Total Inward Leakage UMWA United Mine Workers of America USPS United States Postal Service UVGI Ultraviolet Germicidal Irradiation VA Veterans’ Administration VOC Volatile Organic Compound WHO World Health Organization WoRLD Work-Related Lung Disease WRA Work-Related Asthma