MANAGING HEALTH EFFECTS OF BERYLLIUM EXPOSURE

Committee on Beryllium Alloy Exposures

Committee on Toxicology

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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Committee on Beryllium Alloy Exposures Committee on Toxicology 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 W81K04-06-D-0023 between the National Academy of Sciences and the U.S. Department of Defense. Any opinions, findings, conclusions, or recommenda- tions expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-12532-1 International Standard Book Number-10: 0-309-12532-4 Additional copies of this report are available from The National Academies Press 500 Fifth Street, NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distin- guished 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 pol- icy 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 com- munities. The Council is administered jointly by both Academies and the Institute of Medi- cine. 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 BERYLLIUM ALLOY EXPOSURES Members CHARLES H. HOBBS (Chair), Lovelace Respiratory Research Institute, Albuquerque, NM PATRICK N. BREYSSE, Johns Hopkins University School of Public Health, Baltimore, MD SCOTT BURCHIEL, University of New Mexico, Albuquerque LUNG CHI CHEN, New York University School of Medicine, Tuxedo DAVID DIAZ-SANCHEZ, U.S. Environmental Protection Agency, Chapel Hill, NC (until October 2007) DAVID G. HOEL, Medical University of South Carolina, Charleston LOREN D. KOLLER, Loren Koller & Associates, Corvallis, OR DAVID KRIEBEL, University of Massachusetts, Lowell MICHAEL J. MCCABE, JR., University of Rochester School of Medicine, Rochester, NY CARRIE A. REDLICH, Yale University School of Medicine, New Haven, CT ROSALIND A. SCHOOF, Integral Consulting, Mercer Island, WA NANCY L. SPRINCE, University of Iowa, Iowa City SUSAN M. TARLO, University of Toronto, Toronto, ON, Canada LAURA S. WELCH, CPWR—The Center for Construction Research and Training, Silver Spring, MD Staff SUSAN N. J. MARTEL, Project Director NORMAN GROSSBLATT, Senior Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center PATRICK BAUR, Research Assistant TAMARA DAWSON, Program Associate RADIAH ROSE, Senior Editorial Assistant Sponsor U.S. DEPARTMENT OF DEFENSE v

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COMMITTEE ON TOXICOLOGY Members WILLIAM E. HALPERIN (Chair), UMDNJ–New Jersey Medical School, Newark LAWRENCE S. BETTS, Eastern Virginia Medical School, Norfolk EDWARD C. BISHOP, HDR Engineering, Inc., Omaha, NE JAMES V. BRUCKNER, University of Georgia, Athens GARY P. CARLSON, Purdue University, West Lafayette, IN MARION F. EHRICH, Virginia Polytechnic Institute and State University, Blacksburg SIDNEY GREEN, Howard University, Washington, DC MERYL H. KAROL, University of Pittsburgh, Pittsburgh, PA JAMES N. MCDOUGAL, Wright State University School of Medicine, Dayton, OH ROGER G. MCINTOSH, Science Applications International Corporation, Abingdon, MD GERALD N. WOGAN, Massachusetts Institute of Technology, Cambridge Staff SUSAN N. J. MARTEL, Senior Program Officer for Toxicology EILEEN N. ABT, Senior Program Officer for Risk Analysis ELLEN K. MANTUS, Senior Program Officer MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center TAMARA DAWSON, Program Associate RADIAH A. ROSE, Senior Editorial Assistant vi

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BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members JONATHAN M. SAMET (Chair), Johns Hopkins University, Baltimore, MD RAMON ALVAREZ, Environmental Defense Fund, Austin, TX JOHN M. BALBUS, Environmental Defense Fund, Washington, DC DALLAS BURTRAW, Resources for the Future, Washington, DC JAMES S. BUS, Dow Chemical Company, Midland, MI RUTH DEFRIES, University of Maryland, College Park COSTEL D. DENSON, University of Delaware, Newark E. DONALD ELLIOTT, Willkie, Farr & Gallagher LLP, Washington, DC MARY R. ENGLISH, University of Tennessee, Knoxville J. PAUL GILMAN, Covanta Energy Corporation, Fairfield, NJ SHERRI W. GOODMAN, Center for Naval Analyses, Alexandria, VA JUDITH A. GRAHAM (Retired), Pittsboro, NC WILLIAM P. HORN, Birch, Horton, Bittner and Cherot, Washington, DC WILLIAM M. LEWIS, JR., University of Colorado, Boulder JUDITH L. MEYER, University of Georgia, Athens DENNIS D. MURPHY, University of Nevada, Reno PATRICK Y. O’BRIEN, ChevronTexaco Energy Technology Company, Richmond, CA DOROTHY E. PATTON (Retired), U.S. Environmental Protection Agency, Chicago, IL DANNY D. REIBLE, University of Texas, Austin JOSEPH V. RODRICKS, ENVIRON International Corporation, Arlington, VA ARMISTEAD G. RUSSELL, Georgia Institute of Technology, Atlanta ROBERT F. SAWYER, University of California, Berkeley KIMBERLY M. THOMPSON, Harvard School of Public Health, Boston, MA MONICA G. TURNER, University of Wisconsin, Madison MARK J. UTELL, University of Rochester Medical Center, Rochester, NY CHRIS G. WHIPPLE, ENVIRON International Corporation, Emeryville, CA LAUREN ZEISE, California Environmental Protection Agency, Oakland Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Scholar RAYMOND A. WASSEL, Senior Program Officer for Environmental Studies EILEEN N. ABT, Senior Program Officer for Risk Analysis SUSAN N.J. MARTEL, Senior Program Officer for Toxicology KULBIR BAKSHI, Senior Program Officer ELLEN K. MANTUS, Senior Program Officer RUTH E. CROSSGROVE, Senior Editor 1 This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology. vii

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OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Estimating Mortality Risk Reduction and Economic Benefits from Controlling Ozone Air Pollution (2008) Respiratory Diseases Research at NIOSH (2008) Evaluating Research Efficiency in the U.S. Environmental Protection Agency (2008) Hydrology, Ecology, and Fishes of the Klamath River Basin (2008) Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment (2007) Models in Environmental Regulatory Decision Making (2007) Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007) Sediment Dredging at Superfund Megasites: Assessing the Effectiveness (2007) Environmental Impacts of Wind-Energy Projects (2007) Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Manage- ment and Budget (2007) Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006) New Source Review for Stationary Sources of Air Pollution (2006) Human Biomonitoring for Environmental Chemicals (2006) Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006) Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006) State and Federal Standards for Mobile-Source Emissions (2006) Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005) Health Implications of Perchlorate Ingestion (2005) Air Quality Management in the United States (2004) Endangered and Threatened Species of the Platte River (2004) Atlantic Salmon in Maine (2004) Endangered and Threatened Fishes in the Klamath River Basin (2004) Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003) Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002) Biosolids Applied to Land: Advancing Standards and Practices (2002) The Airliner Cabin Environment and Health of Passengers and Crew (2002) Arsenic in Drinking Water: 2001 Update (2001) Evaluating Vehicle Emissions Inspection and Maintenance Programs (2001) Compensating for Wetland Losses Under the Clean Water Act (2001) A Risk-Management Strategy for PCB-Contaminated Sediments (2001) Acute Exposure Guideline Levels for Selected Airborne Chemicals (six volumes, 2000-2008) Toxicological Effects of Methylmercury (2000) Strengthening Science at the U.S. Environmental Protection Agency (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (2000) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter (four volumes, 1998-2004) The National Research Council’s Committee on Toxicology: The First 50 Years (1997) Carcinogens and Anticarcinogens in the Human Diet (1996) viii

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Upstream: Salmon and Society in the Pacific Northwest (1996) Science and the Endangered Species Act (1995) Wetlands: Characteristics and Boundaries (1995) Biologic Markers (five volumes, 1989-1995) Science and Judgment in Risk Assessment (1994) Pesticides in the Diets of Infants and Children (1993) Dolphins and the Tuna Industry (1992) Science and the National Parks (1992) Human Exposure Assessment for Airborne Pollutants (1991) Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991) Decline of the Sea Turtles (1990) Copies of these reports may be ordered from the National Academies Press (800) 624-6242 or (202) 334-3313 www.nap.edu ix

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OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Review of Toxicologic and Radiologic Risks to Military Personnel from Exposures to Depleted Uranium (2008) Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants, Volume 1 (2007), Volume 2 (2008) Review of the Department of Defense Research Program on Low-Level Exposures to Chemical Warfare Agents (2005) Review of the Army's Technical Guides on Assessing and Managing Chemical Hazards to Deployed Personnel (2004) Spacecraft Water Exposure Guidelines for Selected Contaminants, Volume 1 (2004), Volume 2 (2007) Toxicologic Assessment of Jet-Propulsion Fuel 8 (2003) Review of Submarine Escape Action Levels for Selected Chemicals (2002) Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals (2001) Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) Acute Exposure Guideline Levels for Selected Airborne Contaminants, Volume 1 (2000), Volume 2 (2002), Volume 3 (2003), Volume 4 (2004), Volume 5 (2007), Volume 6 (2007) Review of the US Navy’s Human Health Risk Assessment of the Naval Air Facility at Atsugi, Japan (2000) Methods for Developing Spacecraft Water Exposure Guidelines (2000) Review of the U.S. Navy Environmental Health Center’s Health-Hazard Assessment Process (2000) Review of the U.S. Navy’s Exposure Standard for Manufactured Vitreous Fibers (2000) Re-Evaluation of Drinking-Water Guidelines for Diisopropyl Methylphosphonate (2000) Submarine Exposure Guidance Levels for Selected Hydrofluorocarbons: HFC-236fa, HFC-23, and HFC-404a (2000) Review of the U.S. Army’s Health Risk Assessments for Oral Exposure to Six Chemical- Warfare Agents (1999) Toxicity of Military Smokes and Obscurants, Volume 1(1997), Volume 2 (1999), Volume 3 (1999) Assessment of Exposure-Response Functions for Rocket-Emission Toxicants (1998) Toxicity of Alternatives to Chlorofluorocarbons: HFC-134a and HCFC-123 (1996) Permissible Exposure Levels for Selected Military Fuel Vapors (1996) Spacecraft Maximum Allowable Concentrations for Selected Airborne Contaminants, Volume 1 (1994), Volume 2 (1996), Volume 3 (1996), Volume 4 (2000) x

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Preface Beryllium is a lightweight metal that is used for its exceptional strength and high heat-absorbing capability. Beryllium and its alloys can be found in many important technologies in the defense and aeronautics industries, such as nuclear devices, satellite systems, radar systems, and aircraft bushings and bear- ings. Pulmonary disease associated with exposure to beryllium has been recog- nized and studied since the early 1940s, and an occupational guideline for limit- ing exposure to beryllium has been in place since 1949. Over the last few dec- ades, much has been learned about chronic beryllium disease and factors that contribute to its occurrence in exposed people. Despite reduced workplace expo- sure, chronic beryllium disease continues to occur. In addition, beryllium has been classified as a likely human carcinogen by several agencies, such as the International Agency for Research on Cancer, the National Toxicology Program, and the U.S. Environmental Protection Agency. Those developments have led to debates about the adequacy of the long-standing occupational exposure limit for protecting worker health. To help to determine the steps necessary to protect its workforce from the effects of beryllium used in military aerospace applications, the U.S. Air Force asked the Committee on Toxicology of the National Research Council to conduct an independent review of the scientific literature on beryl- lium and to estimate chronic inhalation exposure levels that are unlikely to pro- duce adverse health effects in military personnel and civilian contractors. In response to the Air Force’s request, the National Research Council con- vened the Committee on Beryllium Alloy Exposures, which prepared this report. The members of the committee were selected for their expertise in pulmonary and occupational medicine, epidemiology, industrial hygiene, inhalation toxi- cology, immunotoxicology, pathology, biostatistics, and risk assessment (see Appendix A for biographic information on the members). To help the committee in its review, two data-gathering meetings were held in early 2007. The committee is grateful to the people who gave presenta- tions on their research in and experience with beryllium exposure and disease. They include John Balmes, University of California, San Francisco); David De- Camp, Air Force Institute of Operational Health; Terry Gordon, New York Uni- xi

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xii Preface versity School of Medicine; Kathleen Kreiss, National Institute for Occupational Safety and Health; David Louis, Air Force Materiel Command; Lisa Maier, Na- tional Jewish Medical and Research Center; Aleksandr Stefaniak, National Insti- tute for Occupational Safety and Health; and Paul Wambach, U.S. Department of Energy. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures ap- proved by the National Research Council’s Report Review Committee. The pur- pose of the 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 of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manu- script remain confidential to protect the integrity of the deliberative process. We thank the following for their review of this report: John Balmes, University of California at San Francisco; Marc Kolanz, Brush Wellman, Inc.; Kathleen Kre- iss, National Institute for Occupational Safety and Health; Michael Luster, con- sultant; Lisa Maier, National Jewish Medical and Research Center; David Michaels, the George Washington University; Martha Sandy, California Envi- ronmental Protection Agency; and Timothy Takaro, Simon Fraser University. Although the reviewers listed above have provided many constructive 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 the report was overseen by Frank Speizer, Harvard School of Public Health. Appointed by the National Research Council, he was responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests en- tirely with the authoring committee and the institution. The committee is grateful for the assistance of National Research Council staff in preparing the report. It particularly wishes to acknowledge the support of Project Director Susan Martel, who coordinated the project and contributed to the committee’s report. Other staff members who contributed to this effort are James Reisa, director of the Board on Environmental Studies and Toxicology; Patrick Baur, research assistant; Tamara Dawson, program associate; Norman Grossblatt, senior editor; and Mirsada Karalic-Loncarevic, manager of the Technical Information Center. Finally, I thank all the members of the committee for their efforts throughout the development of this report. Charles H. Hobbs, DVM, Chair Committee on Beryllium Alloy Exposures

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Contents ABBREVIATIONS ........................................................................................ xvii SUMMARY ........................................................................................................ 3 1 INTRODUCTION ............................................................................. 10 Historical Review of Occupational Exposure Limits, 10 Other Exposure Guidelines, 14 Committee’s Tasks, 14 Committee’s Approach, 15 Organization of the Report, 15 2 EXPOSURE ASSESSMENT ............................................................ 17 Sources and Uses, 18 Toxicokinetics, 23 Review of Exposure Data, 23 Review of Sampling and Analytic Methods, 42 Exposure Metrics, 43 Conclusions and Recommendations, 50 3 EPIDEMIOLOGIC AND CLINICAL STUDIES OF BERYLLIUM SENSITIZATION AND CHRONIC BERYLLIUM DISEASE................................................................... 52 Epidemiologic Literature, 52 Clinical Literature, 70 Conclusions, 83 Recommendations, 83 4 MECHANISMS, GENETIC FACTORS, AND ANIMAL MODELS OF CHRONIC BERYLLIUM DISEASE...................... 85 Pathogenesis and Mechanisms of Action, 85 Genetic Susceptibility, 91 Animal Models of Pulmonary Immunotoxicity and Sensitization, 98 Conclusions, 105 xiii

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xiv Contents 5 GENOTOXICITY AND CARCINOGENICITY.......................... 106 Genotoxicity, 106 Carcinogenicity, 110 Conclusions and Recommendations, 121 6 ASSESSMENT OF OTHER HEALTH END POINTS................ 123 Reproductive and Developmental Effects, 124 Other Effects, 125 Summary, 126 7 DESIGNING A BERYLLIUM EXPOSURE- AND DISEASE- MANAGEMENT PROGRAM FOR WORKERS IN THE AIR FORCE ..................................................................................... 127 Existing Medical Screening or Surveillance Practices, 127 Considerations for the Air Force, 130 Specifics of the Medical Screening Program, 136 REFERENCES............................................................................................... 140 APPENDIX A: BIOGRAPHIC INFORMATION ON THE COMMITTEE ON BERYLLIUM ALLOY EXPOSURES...................................................................... 160 APPENDIX B: AIR FORCE BERYLLIUM PROGRAM CLINICAL DECISION LOGIC ............................................................ 165 BOXES, FIGURES, AND TABLES BOXES S-1 Statement of Task of the Committee on Beryllium Alloy Exposures, 4 FIGURES S-1 Beryllium exposure and disease management program, 7 3-1 Simplified schematic of natural history of beryllium sensitization (BeS) and chronic beryllium disease (CBD), 58 4-1 Immune response to beryllium, 86 7-1 Beryllium exposure and disease management program, 132 7-2 Medical monitoring approach, 135 B-1 BeLPT algorithm, 166

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xv Contents TABLES 1-1 Selected Exposure Guidelines and Actions Taken on Beryllium, 12 2-1 Anthropogenic and Natural Emissions of Beryllium and Beryllium Compounds to the Atmosphere, 19 2-2 Releases of Beryllium Metal to U.S. Environment from Facilities that Produce, Process, or Use It, 20 2-3 Releases of Beryllium Compounds to U.S. Environment from Facilities that Produce, Process, or Use Them (TRI99 2002), 21 2-4 Industries that Use Beryllium, 22 2-5 Summary of Beryllium Airborne-Exposure Studies, 26 2-6 Summary of Beryllium Skin-Exposure and Surface-Exposure Studies, 40 2-7 Physical and Chemical Properties of Beryllium and Beryllium Compounds, 45 2-8 Comparison of Beryllium Concentrations and Particle Sizes Obtained with Different Operations in a Precision Machining Plant, 47 3-1 Summary of Recent Epidemiologic Studies of Chronic Beryllium Disease, 55 3-2 Testing Characteristics in Two Laboratories Performing the BeLPT, 73 4-1 Summary of Association Studies on HLA-DPB1 Glu69 and TNF-α as Susceptibility Factors in Chronic Beryllium Disease and Beryllium Sensitization, 93 4-2 Selected Pulmonary and Immunologic Toxicity Studies in Animals, 99 5-1 Genotoxicity Studies of Beryllium Compounds, 107 5-2 Inhalation-Carcinogenicity Studies of Beryllium, 115 7-1 Summary of Published Beryllium-Exposure Management Programs, 128 7-2 Medical Screening Tests Used in Beryllium-Exposed Populations, 131

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Abbreviations ACGIH American Conference of Governmental Industrial Hygienists AEC Atomic Energy Commission ATSDR Agency for Toxic Substances and Disease Registry BAL bronchoalveolar lavage BeLPT beryllium lymphocyte proliferation test BeS beryllium sensitization CBD chronic beryllium disease CI confidence interval COT Committee on Toxicology DLCO carbon monoxide diffusing capacity DLCO/VA carbon monoxide diffusing capacity per liter of alveolar volume DOE U.S. Department of Energy EPA U.S. Environmental Protection Agency HLA human leukocyte antigen HRCT high-resolution computed tomography IARC International Agency for Research on Cancer LANL Los Alamos National Laboratory LOAEL lowest-observed-adverse-effect level MHC major histocompatibility complex MIF migration-inhibitory factor MMAD mass median aerodynamic diameter MOUDI micro-orifice uniform deposition impactor NIOSH National Institute for Occupational Safety and Health NTP National Toxicology Program OEL occupational exposure limit OR odds ratio OSHA Occupational Safety and Health Administration PPE personal protective equipment PPV positive predictive value RfD reference dose SMR standardized mortality ratio SSA specific surface area xvii

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xviii Abbreviations SUF serum ultrafiltrate TGF transforming growth factor TLV Threshold Limit Value TRI Toxic Release Inventory TWA time-weighted average VD/VT ratio of dead space to tidal volume