Assessment of Exposure-Response Functions for Rocket-Emission Toxicants

Subcommittee on Rocket-Emission Toxicants

Committee on Toxicology

Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.
1998



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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants Assessment of Exposure-Response Functions for Rocket-Emission Toxicants Subcommittee on Rocket-Emission Toxicants Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1998

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants 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 report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. This project was supported by Contract No. DAMD 17-89-C-9086 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. Library of Congress Catalog Card Number 98-86245 International Standard Book Number 0-309-06144-X Additional copies of this report are available from: National Academy Press 2101 Constitution Ave., NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 1998 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants SUBCOMMITTEE ON ROCKET-EMISSION TOXICANTS DONALD E. GARDNER (Chair), Inhalation Toxicology Associates, Raleigh, N.C. CHARLES E. FEIGLEY, University of South Carolina School of Public Health, Columbia, S.C. DAVID W. GAYLOR, U.S. Food and Drug Administration, Jefferson, Ark. THOMAS E. MCKONE, University of California School of Public Health and Lawrence Berkeley National Laboratory, Berkeley, Calif. JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, N.Y. HANSPETER R. WITSCHI, University of California, Davis, Calif. GAROLD S. YOST, University of Utah, Salt Lake City, Utah Staff KULBIR S. BAKSHI, Program Director for the Committee on Toxicology CAROL A. MACZKA, Study Director MARGARET E. McVEY, Staff Officer RUTH E. CROSSGROVE, Editor CATHERINE M. KUBIK, Senior Program Assistant LINDA V. LEONARD, Senior Project Assistant LUCY V. FUSCO, Project Assistant Sponsor U.S. Department of Defense

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants COMMITTEE ON TOXICOLOGY ROGENE F. HENDERSON (Chair), Lovelace Biomedical and Environmental Research Institute, Albuquerque, N.Mex. DONALD E. GARDNER (Vice-Chair), Inhalation Toxicology Associates, Raleigh, N.C. GERMAINE M. BUCK, State University at Buffalo, Buffalo, N.Y. GARY P. CARLSON, Purdue University, West Lafayette, Ind. JACK H. DEAN, Sanofi Winthrop, Inc., Malvern, Pa. KEVIN E. DRISCOLL, The Procter & Gamble Co., Cincinnati, Ohio ELAINE M. FAUSTMAN, University of Washington, Seattle, Wash. CHARLES E. FEIGLEY, University of South Carolina School of Public Health, Columbia, S.C. DAVID W. GAYLOR, U.S. Food and Drug Administration, Jefferson, Ark. JUDITH A. GRAHAM, U.S. Environmental Protection Agency, Research Triangle Park, N.C. IAN A. GREAVES, University of Minnesota, Minneapolis, Minn. SIDNEY GREEN, Corning Hazelton, Inc., Vienna, Va. WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health, Atlanta, Ga. DANIEL KREWSKI, Health Canada, Ottawa, Ont. THOMAS E. McKONE, University of California School of Public Health, Berkeley, Calif. MICHELE A. MEDINSKY, Chemical Industry Institute of Toxicology, Research Triangle Park, N.C. JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, N.Y. ROBERT SNYDER, Environmental and Occupational Health Sciences Institute, Piscataway, N.J. BERNARD M. WAGNER, Wagner Associates, Inc., Millburn, N.J. ANNETTA P. WATSON, Oak Ridge National Laboratory, Oak Ridge, Tenn. HANSPETER R. WITSCHI, University of California, Davis, Calif. GAROLD S. YOST, University of Utah, Salt Lake City, Utah Staff KULBIR S. BAKSHI, Program Director for the Committee on Toxicology SUSAN N.J. PANG, Research Associate RUTH E. CROSSGROVE, Publications Manager KATHRINE IVERSON, Manager of the Toxicology Information Center CATHERINE M. KUBIK, Senior Program Assistant LINDA V. LEONARD, Senior Project Assistant LUCY V. FUSCO, Project Assistant

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS (Chair), University of Washington, Seattle, Wash. DONALD MATTISON (Vice-Chair), University of Pittsburgh, Pittsburgh, Pa. MAY R. BERENBAUM, University of Illinois, Urbana, Ill. EULA BINGHAM, University of Cincinnati, Cincinnati, Ohio PAUL BUSCH, Malcolm Pirnie, Inc., White Plains, N.Y. GEORGE P. DASTON, The Procter & Gamble Co., Cincinnati, Ohio PETER L. DEFUR, Virginia Commonwealth University, Richmond, Va. DAVID L. EATON, University of Washington, Seattle, Wash. ROBERT A. FROSCH, Harvard University, Cambridge, Mass. MARK HARWELL, University of Miami, Miami, Fla. BARBARA HULKA, University of North Carolina, Chapel Hill, N.C. DANIEL KREWSKI, Health Canada and University of Ottawa, Ottawa, Ont. RAYMOND C. LOEHR, The University of Texas, Austin, Tex. JAMES A. MACMAHON, Utah State University, Logan, Utah MARIO J. MOLINA, Massachusetts Institute of Technology, Cambridge, Mass. WARREN MUIR, Hampshire Research Institute, Alexandria, Va. GEOFFREY PLACE, Hilton Head, S.C. MARGARET STRAND, Bayh, Connaughton and Malone, Washington, D.C. BAILUS WALKER, JR., Howard University, Washington, D.C. DIANA WALL, Colorado State University, Ft. Collins, Colo. GERALD N. WOGAN, Massachusetts Institute of Technology, Cambridge, Mass. TERRY F. YOSIE, Ruder Finn Inc., Washington, D.C. Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director, Program Director for Applied Ecology CAROL A. MACZKA, Program Director for Toxicology and Risk Assessment LEE R. PAULSON, Program Director for Resource Management RAYMOND A. WASSEL, Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants COMMISSION ON LIFE SCIENCES THOMAS D. POLLARD (Chair), The Salk Institute, La Jolla, Calif. FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. JOHN C. BAILAR III, University of Chicago, Chicago, Ill. PAUL BERG, Stanford University School of Medicine, Stanford, Calif. JOANNA BURGER, Rutgers University, Piscataway, N.J. SHARON L. DUNWOODY, University of Wisconsin, Madison, Wisc. JOHN L. EMMERSON, Portland, Oreg. NEAL L. FIRST, University of Wisconsin, Madison, Wisc. URSULA W. GOODENOUGH, Washington University, St. Louis, Mo. HENRY W. HEIKKINEN, University of Northern Colorado, Greeley, Colo. HANS J. KENDE, Michigan State University, East Lansing, Mich. CYNTHIA K. KENYON, University of California, San Francisco, Calif. DAVID M. LIVINGSTON, Dana-Farber Cancer Institute, Boston, Mass. THOMAS E. LOVEJOY, Smithsonian Institution, Washington, D.C. DONALD R. MATTISON, University of Pittsburgh, Pittsburgh, Pa. JOSEPH E. MURRAY, Wellesley Hills, Mass. EDWARD E. PENHOET, Chiron Corporation, Emeryville, Calif. MALCOLM C. PIKE, University of Southern California, Los Angeles, Calif. JONATHAN M. SAMET, The Johns Hopkins University, Baltimore, Md. CHARLES F. STEVENS, The Salk Institute, La Jolla, Calif. JOHN L. VANDEBERG, Southwest Foundation for Biomedical Research, San Antonio, Tex. PAUL GILMAN, Executive Director

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (1998) The National Research Council's Committee on Toxicology: The First 50 Years, 1947-1997 (1998) Carcinogens and Anticarcinogens in the Human Diet: A Comparison of Naturally Occurring Synthetic and Natural Substances (1996) Upstream: Salmon and Society in the Pacific Northwest (1996) Science and the Endangered Species Act (1995) Wetlands: Characteristics and Boundaries (1995) Biologic Markers (Urinary Toxicology (1995), Immunotoxicology (1992), Environmental Neurotoxicology (1992), Pulmonary Toxicology (1989), Reproductive Toxicology (1989)) Review of EPA's Environmental Monitoring and Assessment Program (three reports, 1994-1995) Science and Judgment in Risk Assessment (1994) Ranking Hazardous 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) Biologic Markers in Immunotoxicology (1992) 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) Tracking Toxic Substances at Industrial Facilities (1990) Copies of these reports may be ordered from the National Academy Press (800) 624-6242 or (202) 334-3313

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Review of Acute Human-Toxicity Estimates for Selected Chemical-Warfare Agents (1997) Toxicity of Military Smokes and Obscurants, Volume 1 (1997) Toxicologic Assessment of the Army's Zinc Cadmium Dispersion Tests (1997) 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), and Volume 3 (1996) Nitrate and Nitrite in Drinking Water (1995) Guidelines for Chemical Warfare Agents in Military Field Drinking Water (1995) Review of the U.S. Naval Medical Research Institute's Toxicology Program (1994) Health Effects of Permethrin-lmpregnated Army Battle-Dress Uniforms (1994) Health Effects of Ingested Fluoride (1993) Guidelines for Developing Community Emergency Exposure Levels for Hazardous Substances (1993) Guidelines for Developing Spacecraft Maximum Allowable Concentrations for Space Station Contaminants (1992) Review of the U.S. Army Environmental Hygiene Agency Toxicology Division (1991) Permissible Exposure Levels and Emergency Exposure Guidance Levels for Selected Airborne Contaminants (1991)

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants c 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 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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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants PREFACE THE U.S. Air Force is developing a computer model, called the Launch Area Toxic Risk Analysis (LATRA) model, to assist commanders at Cape Canaveral and Vandenberg Air Force Base in determining when it is safe to launch rocket vehicles. LATRA estimates the incidence and types of adverse health effects that might occur in military and civilian populations exposed to the ground cloud created by rocket exhaust during a normal launch or during a catastrophic abort of a rocket that is destroyed near the ground. This report is intended to assist the Air Force in further development of the LATRA model to ensure that the toxicity criteria used to predict health effects are scientifically valid and protective of military and civilian populations. In this report, the Subcommittee on Rocket-Emission Toxicants of the National Research Council's Committee on Toxicology evaluates the toxicity data for three rocket-emission toxicants: hydrogen chloride (HCl), nitrogen dioxide (NO2), and nitric acid (HNO3). The subcommittee also evaluates the exposure-response functions in the LATRA model; the functions translate exposure estimates into probabilities of health effects in populations near a launch site. The subcommittee wishes to thank Col. Gene Killan and Mr. Tim Clapp of Peterson Air Force Base for their support of this project, and Mr. John P. Hinz and Dr. David R. Mattie of the Armstrong Laboratory at Brooks Air Force Base, Dr. Lloyd L. Philipson of ACTA Incorporated, Dr. Jeffrey I. Daniels of Lawrence Livermore National Laboratory, and Dr. Darryl Dargitz of Vandenberg Air Force Base for providing the subcommittee with information on the development and structure of the LATRA model.

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants This report has been reviewed by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will 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 content of the review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The subcommittee wishes to thank the following individuals, who are neither officials nor employees of the NRC, for their participation in the review of this report: Robert T. Drew of Hague, Va.; Yves Alarie of the University of Pittsburgh; Richard B. Schlesinger of New York University Medical Center; Matthew S. Bogdanffy of E.I. du Pont de Nemours; Sati Mazumdar of the University of Pittsburgh; and Calvin Campbell Willhite of the California Environmental Protection Agency. These reviewers have provided many constructive comments and suggestions; it must be emphasized, however, that the authoring subcommittee and the NRC are responsible for the final content of this report. We are also grateful for the assistance of the NRC staff in the preparation of this report. In particular, the subcommittee wishes to acknowledge Carol A. Maczka, director of the Toxicology and Risk Assessment Program of the Board on Environmental Studies and Toxicology; Kulbir S. Bakshi, program director for the Committee on Toxicology; and Margaret E. McVey, staff officer for the subcommittee. Other staff members who contributed to this effort are Ruth E. Crossgrove, editor; Linda V. Leonard, senior program assistant; and Lucy Fusco, project assistant. Finally, we would like to thank the members of the subcommittee for their valuable expertise and dedicated efforts throughout the preparation of this report. Donald E. Gardner, Ph.D. Chair, Subcommittee on Rocket Emission Toxicants Rogene F. Henderson, Ph.D. Chair, Committee on Toxicology

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants CONTENTS     ABBREVIATIONS   xv     EXECUTIVE SUMMARY   1 1   INTRODUCTION   10     Development of LATRA,   11     Organization of this Report,   12 2   DESCRIPTION OF THE LAUNCH AREA TOXIC RISK ANALYSIS(LATRA) MODEL   14     Toxicity of Rocket Emissions,   15     Identification of Sensitive Populations,   15     Definition of Severity of Effects,   17     Selection of the Exposure-Response Model and Independent Variable,   18     Quantification of the Exposure-Response Functions,   19     Representation of Uncertainties,   22 3   SUBPOPULATIONS SENSITIVE TO AIR CONTAMINATION   24     Literature Review for Sensitive Subpopulations,   24     Chemical-Specific Variation in Human Sensitivity,   26     Limitations of Existing Studies,   29     Common Risk-Assessment Practices for Sensitive Subpopulations,   31     Defining Sensitive Populations,   32     Conclusions and Recommendations,   33

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants 4   EFFECT SEVERITY   37     Precedent for Severity Descriptors   37     LATRA's Use of the Term ''Severity"   41     Conclusions and Recommendations   42 5   EVALUATION OF THE LATRA EXPOSURE-RESPONSE FUNCTIONS   45     The LATRA-ERF Model   46     Alternative Approaches   55     Conclusions and Recommendations   61 6   EXPOSURE-RESPONSE FUNCTIONS FOR ROCKET-EMISSION TOXICANTS   67     Nitric Acid   67     Hydrogen Chloride   70     Nitrogen Dioxide   76     Continuous (Nonquantal) Measurements   79     Conclusions and Recommendations   82     REFERENCES   84 APPENDIX A:   AIR FORCE EXPOSURE LIMITS FOR ROCKET EMISSIONS   90 APPENDIX B:   DEFINITIONS OF CURRENT EXPOSURE GUIDANCE LEVELS   98 APPENDIX C:   AMERICAN SOCIETY’S THORACIC’S LIST OF ADVERSE RESPIRATORY HEALTH EFFECTS   103 APPENDIX D:   ACUTE TOXICITY OF HYDROGEN CHLORIDE   105 APPENDIX E:   ACUTE TOXICITY OF NITROGEN DIOXIDE   147 APPENDIX F:   ACUTE TOXICITY OF NITRIC ACID   197

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants ABBREVIATIONS ACGIH American Conference of Governmental Industrial Hygienists AFB Air Force Base ATS American Thoracic Society BAL; bronchoalveolar lavage CEL continuous exposure limit, now called CEGL (see below) CEGL continuous exposure guidance level (NRC guideline) COT Committee on Toxicolo gy CT product of exposure concentration and time DOD U.S. Department of Defense DHHS Department of Human Health Services EEC estimated exposure concentration EEGL emergency exposure guidance level (NRC guideline) EEL emergency exposure limit, now called EEGL (see above) ERF exposure-response function EPA U.S. Environmental Protection Agency ERPG Emergency Response Planning Guideline FDA U.S. Food and Drug Administration GSD geometric standard deviation HCl hydrogen chloride HNO3 nitric acid ICBM intercontinental ballistic missile IDLH immediately dangerous to life and health LATRA Launch Area Toxic Risk Analysis LC50 lethal concentration for 50% of the test animals LCT50 concentration multiplied by exposure time that is lethal to 50% of the test animals

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants LD50 lethal dose for 50% of the test animals LOAEL lowest-observed-adverse-effect level LOC level of concern (EPA guideline) N2O4 nitrogen tetroxide NAS National Academy of Sciences NHIS National Health Interview Survey NIOSH National Institute for Occupational Safety and Health NO2 nitrogen dioxide NOAEL no-observed-adverse-effect level NOEL no-observed-effect level NRC National Research Council OEL occupational exposure limit OSHA Occupational Safety and Health Administration PEL permissible exposure level (OSHA standard) PM-10 particulate matter less than 10 µm in diameter PMN polymorphonuclear neutrophils RD50 concentration (or dose) that produces a 50% decrease in respiratory rate REEDM Rocket Exhaust Effluent Diffusion Model REL recommended exposure limit (NIOSH recommendation) REWG Rocket Emissions Working Group RTV reference toxicity value SPEGL short-term public emergency guidance level (NRC guideline) STEL short-term exposure limit (NRC guideline) STPL short-term public limit (NRC guideline) TLV threshold limit value (ACGIH guideline) TWA time-weighted average VAFB Vandenberg Air Force Base

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Assessment of Exposure-Response Functions for Rocket-Emission Toxicants Assessment of Exposure-Response Functions for Rocket-Emission Toxicant

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