REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS

Subcommittee on Toxicological Hazard and Risk Assessment

Committee on Toxicology

Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Subcommittee on Toxicological Hazard and Risk Assessment Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W. Washington, D.C. 20418 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 Nos. DAMD17-89-C-9086 and DAMD17-99-C-9049 between the National Academy of Sciences and U.S. Army. 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 0-309-07147-X Additional copies of this report are available from: National Academy Press 2101 Constitution Ave., NWBox 285 Washington, DC 20055 800-624-6242202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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 achievements of engineers. Dr. William 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 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Subcommittee on Toxicological Hazard and Risk Assessment ROGENE HENDERSON (CHAIR), Lovelace Respiratory Research Institute, Albuquerque, New Mexico GERMAINE M. BUCK, University at Buffalo, State of New York JACK H. DEAN, Sanofi-Synthelabo, Inc., Malvern, Pennsylvania KEVIN E. DRISCOLL, Proctor and Gamble Pharmaceuticals, Cincinnati, Ohio DAVID W. GAYLOR, U.S. Food and Drug Administration, Jefferson, Arkansas JUDITH A. GRAHAM, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, New York ROBERT SNYDER, Rutgers University, Piscataway, New Jersey BERNARD M. WAGNER, Consultant, Short Hills, New Jersey ANNETTA P. WATSON, Oak Ridge National Laboratory, Oak Ridge, Tennessee HANSPETER R. WITSCHI, University of California, Davis, California Staff KULBIR S. BAKSHI, Project Director ROBERT J. CROSSGROVE, Editor MIRSADA KARALIC-LONCAREVIC, Information Specialist TANYA LEE, Acting Project Assistant Sponsor U.S. DEPARTMENTOF DEFENSE

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS COMMITTEE ON TOXICOLOGY BAILUS WALKER, JR. (Chair), Howard University Medical Center and American Public Health Association, Washington, D.C. MELVIN E. ANDERSEN, Colorado State University, Denver, Colorado GERMAINE M. BUCK, University at Buffalo, State of New York ROBERT E. FORSTER II, University of Pennsylvania, Philadelphia, Pennsylvania PAUL M.D. FOSTER, Chemical Industry Institute of Toxicology, Research Triangle Park, North Carolina WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health, Cincinnati, Ohio CHARLES H. HOBBS, Lovelace Respiratory Research Institute and Lovelace Biomedical and Environmental Research Institute, Albuquerque, New Mexico SAM KACEW, Department of Pharmacology Faculty of Medicine and University of Ottawa, Ontario,Canada NANCY KERKVLIET, Oregon State University, Agricultural and Life Sciences, Corvallis, Oregon FLORENCE K. KINOSHITA, Hercules Incorporated, Wilmington, Delaware MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver, Colorado MORTON LIPPMANN, New York University School of Medicine, Tuxedo, New York ERNEST E. MCCONNELL, ToxPath, Inc., Raleigh, North Carolina THOMAS E. MCKONE, Lawrence Berkeley National Laboratory and University of California, Berkeley, California HARIHARA MEHENDALE, The University of Louisiana at Monroe, Monroe, Louisiana DAVID H. MOORE, Battelle Memorial Institute, Bel Air, Maryland GÜNTER OBERDÖRSTER, University of Rochester, Rochester, New York JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, New York GEORGE M. RUSCH, AlliedSignal, Inc., Morristown, New Jersey MARY E. VORE, University of Kentucky, Lexington, Kentucky ANNETTA P. WATSON, Oak Ridge National Laboratory, Oak Ridge, Tennessee LAUREN ZEISE, Office of Environmental Health Hazard Assessment, Oakland, California Staff KULBIR S. BAKSHI, Program Director SUSAN N.J. PANG, Program Officer ABIGAIL E. STACK, Program Officer KATHRINE J. IVERSON, Manager, Toxicology Information Center TANYA LEE, Acting Project Assistant EMILY SMAIL, Project Assistant

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS (Chair), University of Washington, Seattle, Washington DONALD MATTISON (Vice Chair), March of Dimes, White Plains, New York DAVID ALLEN, University of Texas, Austin, Texas INGRID C. BURKE, Colorado State University, Fort Collins, Colorado WILLIAM L CHAMEIDES, Georgia Institute of Technology, Atlanta, Georgia JOHN DOULL, University of Kansas Medical Center, Kansas City, Kansas CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, California JOHN GERHART, University of California, Berkeley, California J. PAUL GILMAN, Celera Genomics, Rockville, Maryland BRUCE D. HAMMOCK, University of California, Davis, California MARK HARWELL, University of Miami, Miami, Florida ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New Mexico CAROL HENRY, Chemical Manufacturers Association, Arlington, Virginia BARBARA HULKA, University of North Carolina, Chapel Hill, North Carolina JAMES F. KITCHELL, University of Wisconsin, Madison, Wisconsin DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario JAMES A. MACMAHON, Utah State University, Logan, Utah MARIO J. MOLINA, Massachusetts Institute of Technology, Cambridge, Massachusetts CHARLES O'MELIA, Johns Hopkins University, Baltimore, Maryland WILLEM F. PASSCHIER, Health Council of the Netherlands KIRK SMITH, University of California, Berkeley, California MARGARET STRAND, Oppenheimer Wolff Donnelly & Bayh, LLP, Washington, D.C. TERRY F. YOSIE, Chemical Manufacturers Association, Arlington, Virginia Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director and Senior Program Director for Applied Ecology CAROL A. MACZKA, Senior Program Director for Toxicology and Risk Assessment RAYMOND A. WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology LEE R. PAULSON, Program Director for Resource Management ROBERTA M. WEDGE, Program Director for Risk Analysis

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS COMMISSION ON LIFE SCIENCES MICHAEL T. CLEGG (Chair), University of California, Riverside, California PAUL BERG (Vice Chair), Stanford University, Stanford, California FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. JOANNA BURGER, Rutgers University, Piscataway, New Jersey JAMES E. CLEAVER, University of California, San Francisco, California DAVID S. EISENBERG, University of California, Los Angeles, California JOHN L. EMMERSON, Fishers, Indiana NEAL L. FIRST, University of Wisconsin, Madison, Wisconsin DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, California ARTURO GOMEZ-POMPA, University of California, Riverside, California COREY S. GOODMAN, University of California, Berkeley, California JON W. GORDON, Mount Sinai School of Medicine, New York, New York DAVID G. HOEL, Medical University of South Carolina, Charleston, South Carolina BARBARA S. HULKA, University of North Carolina, Chapel Hill, North Carolina CYNTHIA J. KENYON, University of California, San Francisco, California BRUCE R. LEVIN, Emory University, Atlanta, Georgia DAVID M. LIVINGSTON, Dana-Farber Cancer Institute, Boston, Massachusetts DONALD R. MATTISON, March of Dimes, White Plains, New York ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, California ROBERT T. PAINE, University of Washington, Seattle, Washington RONALD R. SEDEROFF, North Carolina State University, Raleigh, North Carolina ROBERT R. SOKAL, State University of New York, Stony Brook, New York CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, California SHIRLEY M. TILGHMAN, Princeton University, Princeton, New Jersey RAYMOND L. WHITE, University of Utah, Salt Lake City, Utah Staff WARREN R. MUIR, Executive Director JACQUELINE K. PRINCE, Financial Officer BARBARA B. SMITH, Administrative Associate LAURA T. HOLLIDAY, Senior Program Assistant

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Strengthening Science at the U.S. Environmental Protection Agency: Research Management and Peer Review Practice (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Modeling Mobile-Source Emissions (2000) Copper in Drinking Water (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (1999) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (1998); II. Evaluating Research Progress and Updating the Portfolio (1999) Ozone-Forming Potential of Reformulated Gasoline (1999) Risk-Based Waste Classification in California (1999) Arsenic in Drinking Water (1999) Brucellosis in the Greater Yellowstone Area (1998) The National Research Council's Committee on Toxicology: The First 50 Years (1997) Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests (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 reports, 1989-1995) Review of EPA's Environmental Monitoring and Assessment Program (3 reports, 1994-1995) Science and Judgment in Risk Assessment (1994) Ranking Hazardous Waste Sites for Remedial Action (1994) Pesticides in the Diets of Infants and Children (1993) Issues in Risk Assessment (1993) Setting Priorities for Land Conservation (1993) Protecting Visibility in National Parks and Wilderness Areas (1993) Dolphins and the Tuna Industry (1992) Hazardous Materials on the Public Lands (1992) Science and the National Parks (1992) Animals as Sentinels of Environmental Health Hazards (1991) Assessment of the U.S. Outer Continental Shelf Environmental Studies Program, Volumes I-IV (1991-1993) Human Exposure Assessment for Airborne Pollutants (1991) Monitoring Human Tissues for Toxic Substances (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 Academy Press (800) 624-6242 or (202) 334-3313 www.nap.edu

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers (2000) Submarine Exposure Guidance Levels for Selected Hydrofluorocarbons: HFC-236fa, HFC-23, and HFC-404a (2000) Health Risk Assessment of Selected Flame-Retardant Chemicals (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) Review of a Screening Level Risk Assessment for the Naval Air Facility at Atsugi, Japan (Letter Report) (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, Vol. 1 (1994), Vol. 2 (1996), Vol. 3 (1996), Vol. 4 (2000)

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Preface THE U.S. NAVY Environmental Health Center (NEHC) supports the preventive medicine program of the Navy, especially in the areas of occupational health and public health. NEHC receives numerous requests to evaluate potential health hazards associated with materials used by the Navy and Marine Corps. In response to such requests, NEHC develops and reviews toxicological and related data and makes recommendations of acceptable exposures to these materials based on their potential to produce toxic effects in humans. As part of its efforts to protect Navy personnel and their families from exposures to toxic chemicals, the Navy's Office of the Surgeon General asked the National Research Council (NRC) to independently review the adequacy of the NEHC health- hazard assessment (HHA) process. The NRC assigned this task to the Committee on Toxicology (COT) of the Board on Environmental Studies and Toxicology. The COT established the Subcommittee on Toxicological Hazard Evaluation, which prepared this report. The subcommittee was asked to assess the validity and effectiveness of NEHC's HHA process; to determine whether the process as implemented provides the Navy with state-of-the-art, comprehensive, and defensible evaluations of toxicological hazards; and to identify any program elements that require improvement. This report is intended to provide NEHC with recommendations that will improve and strengthen the HHA process and aid the Navy's efforts related to preventive medicine. The subcommittee gratefully acknowledges Capt. David Macys, Capt.

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Richard Buck, Commander William Luttrell, Capt. George Kramer, Capt. Kenneth Still, James Crawl, Gerald Drewyer, Andrea Lunsford, Vera Wang, Charles Gross, Steven Sorgen (all from the U.S. Navy), and Dr. Ronald Wolff (Lilly Research Laboratories) for providing background information and for making presentations to the subcommittee. This report has been reviewed by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures for reviewing NRC reports approved by the NRC's Report Review Committee. The purpose of this independent review was to provide candid and critical comments to assist the NRC in making the 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, who are neither officials nor employees of the NRC, for their participation in the review of this report: Sidney Green, Howard University; George Rusch, AlliedSignal, Inc.; Donald Gardner, Inhalation Toxicology Associates; Joseph Barzelleca, Virginia Commonwealth University, and John Doull, University of Kansas Medical Center. The individuals listed above have provided many constructive comments and suggestions. It may be emphasized, however, that responsibility for the final content of this report rests entirely with the authoring committee and the NRC. The subcommittee was ably guided and assisted by staff of the NRC 's Board on Environmental Studies and Toxicology, especially Kulbir S. Bakshi (project director), Robert Crossgrove (editor), Evelyn Simeon, and Pamela Friedman (project administrative assistants). These staff members merit special recognition for their thoughtful contributions and extraordinary efforts in producing the report. Finally, we would like to express my thanks and admiration to the members of the subcommittee for their dedicated efforts throughout the development of the report. Rogene Henderson, Chair Subcommittee on Toxicological Hazard and Risk Assessment Bailus Walker, Chair Committee on Toxicology

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Contents     ABBREVIATIONS   xv     EXECUTIVE SUMMARY   1  1   INTRODUCTION   11      Background,   12      Subcommittee's Approach to the Charge,   13      Structure of this Report,   14  2   THE NAVY'S CURRENT HEALTH-HAZARD ASSESSMENT PROCESS   15      Navy Policies and Directives Related to Hazardous Substance,   15      Navy's Current Health-Hazard Assessment Process,   19      NEHC's Process for Preparing HHA Reports,   24      Special Considerations for Risk Assessments: Populations at Risk,   31      Exposure Information for Health-Hazard Assessments,   32      Human Resources Available to Conduct Health-Hazard Assessments,   33      Information Systems Used for Hazard Assessments,   34      Peer Review of Reports,   35

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS  3   OTHER RELATED HEALTH-HAZARD ASSESSMENT PROCESSES   37      Consumer Product and Pharmaceutical Industries,   37      U.S. Army Center for Health Promotion and Preventive Medicine,   41      Recommendation,   44  4   CONCLUSIONS AND RECOMMENDATIONS   45      Documentation and Development of Standard Operating Procedures,   46      Staffing,   47      Data Acquisition and Management,   50      Information Sources for Conducting Health-Hazard Assessments,   51      Quality Assurance and Quality Control,   53      Communication Within Other Navy Programs and With Other Organizations,   54      Medical Surveillance and Centralization of Medical Data,   56      Life-Cycle Assessment,   56      Overall Summary,   57     REFERENCES   58  APPENDIX A   History of NEHC and Its Relationship with Other Navy Organizations   63  APPENDIX B   Department of Defense and Navy Directives and Regulations Relating to the Use of Hazardous Materials.   67

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Abbreviations AAALAC American Association for the Accreditation of Laboratory Animal Care ACGIH American Conference of Governmental Industrial Hygienists AEGL acute exposure guideline level AEHA U.S. Army Environmental Hygiene Agency (now known as CHPPM) AIHA American Industrial Hygiene Association ATSDR Agency for Toxic Substances and Disease Registry BUMED Bureau of Medicine and Surgery CEGL continuous exposure guidance level CHPPM U.S. Army Center for Health Promotion and Preventive Medicine CNO Chief of Naval Operations COT Committee on Toxicology DOD Department of Defense DON Department of the Navy DTIC Defense Technical Information Center EEGL emergency exposure guidance level EPA U.S. Environmental Protection Agency GLP good laboratory practice HCS hazard communication standard

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS HEAST health effects assessment summary table HHA health hazard assessment HMD Hazardous Materials Department HSDB Hazardous Substances Data Base IARC International Agency for Research on Cancer IERA Institute for Environment, Safety, and Occupational Health Risk Analysis IH industrial hygiene IPCS International Program on Chemical Safety IRIS Integrated Risk Information System ISO International Organization for Standardization LCA life-cycle assessment MSDS Material Safety Data Sheet NAVOSH Navy Occupational Safety and Health NEHC Navy Environmental Health Center NHRC Naval Health Research Center NIOSH National Institute for Occupational Safety and Health NHRC/TD Naval Health Research Center's Toxicology Detachment NRC National Research Council ORNL Oak Ridge National Laboratory OSHA Occupational Safety and Health Administration QA/QC quality assurance/quality control QAO Quality Assurance Office RTECS Registry of Toxic Effects SOP standard operating procedure SECNAV Secretary of the Navy SMAC spacecraft maximum allowable concentration WPAFB Wright-Patterson Air Force Base

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS Review of the U.S. Navy Environmental Health Center's Health-Hazard Assessment Process

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REVIEW OF THE U.S. NAVY ENVIRONMENTAL HEALTH CENTER'S HEALTH-HAZARD ASSESSMENT PROCESS