REVIEW OF THE ARMY’S TECHNICAL GUIDES ON ASSESSING AND MANAGING CHEMICAL HAZARDS TO DEPLOYED PERSONNEL

Subcommittee on the Toxicological Risks to Deployed Military Personnel

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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Subcomm ittee on the Toxicological Risks to Deployed Military Personnel Com mittee 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, D.C. 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. DAMD 17-99-C-9049 between the National Academy of Sciences and the U.S. Department of Defense. 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 0-309-09221-3 (Book) International Standard Book Number 0-309-53239-6 (PDF) 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 2004 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 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. Bruce M. Alberts 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 achieve- ments of engineers. Dr. Wm. A. Wulf 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 responsibil- ity 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 scien- tific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council www.national-academies.org

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SUBCOMMITTEE ON TOXICOLOGICAL RISKS TO DEPLOYED MILITARY PERSONNEL RICHARD J. BULL (Chair), Consultant, Richland, WA EDWARD BISHOP, Parsons Corporation, Fairfax, VA KENNETH T. BOGEN, Lawrence Livermore National Laboratory, Livermore, CA BARBARA CALLAHAN, University Research Engineers and Associates, Grantham, NH JUDITH GRAHAM, American Chemistry Council, Arlington, VA DAVID MOORE, Battelle Eastern Science and Technology Center, Aberdeen, MD DEBORAH IMEL NELSON, University of Oklahoma, Norman CHARLES F. REINHARDT, Consultant, Chadds Ford, PA ROSALIND A. SCHOOF, Integral Consulting, Inc., Mercer Island, WA ROBERT G. TARDIFF, The Sapphire Group, Inc., Vienna, VA NGA L. TRAN, Exponent, Inc., Washington, DC Staff SUSAN N.J. MARTEL, Project Director KELLY CLARK, Editor TAMARA DAWSON, Program Assistant Sponsor: U.S. Department of Defense v

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COMMITTEE ON TOXICOLOGY BAILUS WALKER, JR. (Chair), Howard University Medical Center and American Public Health Association, Washington, DC MELVIN E. ANDERSEN, CIIT-Centers for Health Research, Research Triangle Park, NC EDWARD C. BISHOP, Parsons Corporation, Fairfax, VA GARY P. CARLSON, Purdue University, West Lafayette, IN JANICE E. CHAMBERS, Mississippi State University, Mississippi State LEONARD CHIAZZE, JR., Georgetown University, Washington, DC JUDITH A. GRAHAM, American Chemistry Council, Arlington, VA SIDNEY GREEN, Howard University, Washington, DC MERYL KAROL, University of Pittsburgh, Pittsburgh, PA STEPHEN U. LESTER, Center for Health Environment and Justice, Falls Church, VA DAVID H. MOORE, Battelle Memorial Institute, Bel Air, MD CALVIN C. WILLHITE, Department of Toxic Substances, State of California, Berkeley GERALD WOGAN, Massachusetts Institute of Technology, Cambridge Staff KULBIR S. BAKSHI, Program Director ROBERTA M. WEDGE, Senior Program Officer for Risk Analysis SUSAN N. J. MARTEL, Senior Program Officer ELLEN K. MANTUS, Senior Program Officer KELLY CLARK, Assistant Editor AIDA NEEL, Senior Program Assistant TAMARA DAWSON, Program Assistant vi

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BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members JONATHAN M. SAMET (Chair), Johns Hopkins University, Baltimore, MD DAVID ALLEN, University of Texas, Austin THOMAS BURKE, Johns Hopkins University, Baltimore, MD JUDITH C. CHOW, Desert Research Institute, Reno, NV COSTEL D. DENSON, University of Delaware, Newark E. DONALD ELLIOTT, Willkie, Farr & Gallagher, LLP, Washington, DC CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, CA WILLIAM H. GLAZE, Oregon Health and Science University, Beaverton SHERRI W. GOODMAN, Center for Naval Analyses, Alexandria, VA DANIEL S. GREENBAUM, Health Effects Institute, Cambridge, MA ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, NM CAROL HENRY, American Chemistry Council, Arlington, VA ROBERT HUGGETT, Michigan State University, East Lansing BARRY L. JOHNSON Emory University, Atlanta, GA JAMES H. JOHNSON, Howard University, Washington, DC JUDITH L. MEYER, University of Georgia, Athens PATRICK Y. O’BRIEN, ChevronTexaco Energy Technology Company, Richmond, CA DOROTHY E. PATTON, International Life Sciences Institute, Washington, DC STEWARD T.A. PICKETT, Institute of Ecosystem Studies, Millbrook, NY ARMISTEAD G. RUSSELL, Georgia Institute of Technology, Atlanta LOUISE M. RYAN, Harvard University, Boston, MA KIRK SMITH, University of California, Berkeley LISA SPEER, Natural Resources Defense Council, New York, NY G. DAVID TILMAN, University of Minnesota, St. Paul CHRIS G. WHIPPLE, Environ Incorporated, Emeryville, CA LAUREN A. ZEISE, California Environmental Protection Agency, Oakland Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Scholar RAYMOND A. WASSEL, Senior Program Officer for Environmental Sciences and Engineering KULBIR BAKSHI, Senior Program Officer for Toxicology ROBERTA M. WEDGE, Senior Program Officer for Risk Analysis K. JOHN HOLMES, Senior Program Officer SUSAN N.J. MARTEL, Senior Program Officer SUZANNE VAN DRUNICK, Senior Program Officer EILEEN N. ABT, 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 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) Ecological Dynamics on Yellowstone’s Northern Range (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 (4 volumes, 2000-2003) 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) Modeling Mobile-Source Emissions (2000) Waste Incineration and Public Health (1999) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter (4 volumes, 1998-2003) Ozone-Forming Potential of Reformulated Gasoline (1999) The National Research Council’s Committee on Toxicology: The First 50 Years (1997) Carcinogens and Anticarcinogens in the Human Diet (1996) Upstream: Salmon and Society in the Pacific Northwest (1996) Science and the Endangered Species Act (1995) Wetlands: Characteristics and Boundaries (1995) Biologic Markers (5 volumes, 1989-1995) Review of EPA's Environmental Monitoring and Assessment Program (3 volumes, 1994-1995) 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 viii

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OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Spacecraft Water Exposure Guidelines for Selected Contaminants, Volume 1 (2004) 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) 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) ix

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Preface Military deployments include a spectrum of military activities ranging from peace-keeping, humanitarian, and nation-building missions to combat. In deployment situations, commanders must consider and balance a variety of hazards to the mission and to the health of their troops. To facilitate consideration of chemical threats in the decision-making process for mis- sion planning, the U.S. Army has developed two technical guides (Techni- cal Guide 230 and Technical Guide 248) and one reference guide (Refer- ence Document 230) that outline a process by which chemical hazards can be characterized in terms of their health risks and categorized in terms of their impact on the mission (e.g., mission capable, combat ineffective). A key element of the guidance was the establishment of military exposure guidelines (MEGs) for air, water, and soil that are to be used for assessing the significance of field exposures to chemical hazards during deployment. In this report, the National Research Council’s (NRC) Subcommittee on Toxicological Risks to Deployed Military Personnel evaluates the Army’s three guidance documents for their scientific validity and adequacy in characterizing chemical risks for comparison with other health and opera- tional risks. Specifically, the subcommittee evaluated the adequacy of the proposed MEGs for assessing risks to soldier health and missions, the meth- ods and special military considerations that should be used in developing exposure guidelines, and the application of the guidelines. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with proce- dures approved by the NRC’s Report Review Committee. The purpose of xi

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xii PREFACE 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, evi- dence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the delibera- tive process. We wish to thank the following individuals for their review of this report: Germaine Buck, National Institute of Child Health and Human Development Jeffrey Fisher, University of Georgia Howard Kipen, University of Medicine and Dentistry of New Jersey David Macys, University of Washington Roger O. McClellan, Albuquerque, New Mexico Lorenz Rhomberg, Gradient Corporation Joseph Rodricks, ENVIRON International Corporation Smita Siddhanti, EnDyna, Inc. Palmer W. Taylor, University of California, San Diego 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 this report was overseen by Gilbert Omenn, Univer- sity of Michigan, and Raymond Wymer, Oak Ridge, Tennessee. Appointed by the NRC, 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. Re- sponsibility for the final content of this report rests entirely with the authoring committee and the institution. The subcommittee gratefully acknowledges the following individuals for making presentations and providing information to the subcommittee: LTC John Ciesla, U.S. Army Center for Health Promotion and Preventive Medicine (USACHPPM); Ellen Embry, Deputy Assistant Secretary of Defense for Force Health Protection; Robert Garrett, Armed Forces Medical Intelligence Center; Veronique Hauschild, USACHPPM; Jack Heller, USACHPPM; Joleen Mobley, USACHPPM; and Tony Pitrat, USACH- PPM. The subcommittee is also grateful for the assistance of the NRC staff in preparing this report. It particularly wishes to acknowledge the contribu- tions of Susan Martel, project director, who coordinated the project and

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xiii PREFACE contributed to the subcommittee’s report. Other staff members who con- tributed to this effort are Kulbir Bakshi, senior program officer for toxicol- ogy; Kelly Clark, assistant editor; Mirsada Karalic-Loncarevic, research associate; and Tamara Dawson, program assistant. We would especially like to thank all the members of the subcommittee for their efforts throughout the development of this report. Richard J. Bull, Chair Subcommittee on Toxicological Risks to Deployed Military Personnel Bailus Walker, Chair Committee on Toxicology

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Contents ABBREVIATIONS................................................................................xvii SUMMARY...............................................................................................1 1 INTRODUCTION...............................................................................16 Background, 16 Guidance Documents, 21 Statement of Task, 23 The Subcommittee’s Approach, 24 References, 25 2 REVIEW OF THE ARMY’S TECHNICAL GUIDANCE...............27 Earlier Academies Reports on Developing Reliable Comparative Risk Assessments for Deployments, 27 The Army’s Risk Assessment Guidance for Deployment, 30 Recommendations, 45 References, 46 3 REVIEW OF KEY CONCEPTS, ASSUMPTIONS, AND DECISIONS MADE IN DEVELOPING TG-248, TG-230, AND RD-230.....................................................................................47 Use of Pre-Existing Exposure Guidelines, 47 Acceptable Cancer Risk, 60 Consideration of Immediate and Long-term Health Effects, 63 Aggregate Exposure and Cumulative Risk, 65 Exposure Assessment, 67 xv

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xvi CONTENTS Utility for Decision Makers, 70 Recommendations, 71 References, 72 4 A NEW SET OF EXPOSURE GUIDELINES: CHEMICAL CASUALTY ESTIMATING GUIDELINES...............76 Introduction, 76 Derivation of Chemical Casualty Estimating Guidelines, 78 Application and Interpretation of CCEGs, 84 Aggregate Exposure and Cumulative Risk, 87 Recommendations, 87 References, 89 5 PROCESS FOR ESTABLISHING AND APPLYING MILITARY EXPOSURE GUIDELINES............................................91 Air Exposure Guidelines, 91 Drinking Water Guidelines, 105 Soil Exposure Guidelines, 110 Application of MEGs, 119 Recommendations, 125 References, 127 Appendix A. Errata, Inconsistencies, and Comments on Specific Aspects of TG-248, TG-230, and RD-230, 133 Appendix B. Review of Acceptable Cancer Risk Levels, 137 Appendix C. Example Use of Probits for Developing Chemical Casualty Estimating Guidelines, 145 Appendix D. Critical Studies and Uncertainty Factors Used in Developing Acute Exposure Guideline Levels for Chemical Warfare Agents, 175 Appendix E. Probabilistic Approach to Address Exposure to Multiple Chemicals for Course-of-Action Analysis, 181 Appendix F. Biographical Information on the Subcommittee on Toxicological Risks to Deployed Military Personnel, 187 Appendix G. Definitions, 193

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Abbreviations ACGIH American Conference of Governmental Industrial Hygienists AEGL acute exposure guideline level ATSDR Agency for Toxic Substances and Disease Registry BW body weight CCEG chemical casualty estimating guideline CEGL continuous exposure guidance level CSF cancer slope factors CWA chemical warfare agent EEGL emergency exposure guidance level ERPG emergency response planning guideline FDWS field drinking water standards GSD geometric standard deviation HA health advisory HEAST health effects assessment summary tables HI hazard index HQ hazard quotient HSDB hazardous substance databank IOM Institute of Medicine IRIS Integrated Risk Information System LOAEL lowest-observed-adverse-effect level MAF military adjustment factor MCGL maximum contaminant level goal MCL maximum contaminant level xvii

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xviii ABBREVIATIONS MEG military exposure guideline MCRC military cancer risk concentration MF modifying factor MRC military risk concentration MRL minimal risk level NAAQS national ambient air quality standards NIOSH National Institute of Safety and Occupational Health NOAEL no-observed-adverse-effect level NRC National Research Council OEH/ED occupational and environmental health/endemic disease ORM operational risk management OSHA Occupational Safety and Health Administration PEF particulate emission factor PEGL permissible exposure guideline level PEL permissible exposure limit PMEG-L preliminary military exposure guidelines–long-term PPE personal protective equipment PRG preliminary remediation goal PSI pollution standard index RBC risk-based concentration REL recommended exposure level RfC reference concentration RfD reference dose SPEGL short-term public guidance level SSL soil screening level STEL short-term exposure level TEEL temporary emergency exposure limit THQ target hazard quotient TLV Threshold Limit Value UF uncertainty factor VOC volatile organic compound

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Review of the Army’s Technical Guides on Assessing and Managing Chemical Hazards to Deployed Personnel

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