Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals

Subcommittee on Acute Exposure Guideline Levels

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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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Subcommittee on Acute Exposure Guideline Levels 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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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals 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 the 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 0-309-07553-X Library of Congress Control Number: 2001090090 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 2001 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals 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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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals SUBCOMMITTEE ON ACUTE EXPOSURE GUIDELINE LEVELS DANIEL KREWSKI, (Chair), University of Ottawa, Ottawa, Ontario EDWARD C.BISHOP, Parsons Engineering Science, Inc., Fairfax, Virginia JAMES V.BRUCKNER, University of Georgia, Athens JOHN DOULL, University of Kansas Medical Center, Kansas City DONALD E.GARDNER, Inhalation Toxicology Associates, Inc., Raleigh, North Carolina DAVID W.GAYLOR, U.S. Food and Drug Administration, Jefferson, Arkansas FLORENCE K.KINOSHITA, Hercules Incorporated, Wilmington, Delaware STEPHEN U.LESTER, Center for Health, Environment and Justice, Falls Church, Virginia HARIHARA MEHENDALE, University of Louisiana, Monroe RICHARD B.SCHLESINGER, New York University School of Medicine, Tuxedo CALVIN C.WILLHITE, State of California, Berkeley Staff KULBIR S.BAKSHI, Project Director RUTH E.CROSSGROVE, Editor AIDA NEEL, Administrative Assistant Sponsor: U.S. Department of Defense

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals 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 GERMAINE M.BUCK, National Institute of Health, Washington, D.C. ROBERT E.FORSTER II, University of Pennsylvania, Philadelphia 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, University of Ottawa, Ottawa, Ontario NANCY KERKVLIET, Oregon State University, Corvallis MICHAEL J.KOSNETT, University of Colorado Health Sciences Center, Denver MORTON LIPPMANN, New York University School of Medicine, Tuxedo ERNEST E.MCCONNELL, ToxPath, Inc., Raleigh, North Carolina THOMAS E.MCKONE, Lawrence Berkeley National Laboratory and University of California, Berkeley HARIHARA MEHENDALE, University of Louisiana, Monroe DAVID H.MOORE, Battelle Memorial Institute, Bel Air, Maryland LAUREN ZEISE, California Environmental Protection Agency, Oakland Staff KULBIR S.BAKSHI, Program Director SUSAN N.J.MARTEL, Program Officer ABIGAIL E.STACK, Program Officer RUTH E.CROSSGROVE, Publications Manager AIDA NEEL, Administrative Assistant JESSICA BROCK, Project Assistant

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS (Chair), University of Washington, Seattle JOHN DOULL, University of Kansas Medical Center, Kansas City DAVID ALLEN, University of Texas, Austin INGRID C.BURKE, Colorado State University, Fort Collins THOMAS BURKE, Johns Hopkins University, Baltimore, Maryland GLEN R.CASS, Georgia Institute of Technology, Atlanta WILLIAM L.CHAMEIDES, Georgia Institute of Technology, Atlanta CHRISTOPHER B.FIELD, Carnegie Institute of Washington, Stanford, California JOHN GERHART, University of California, Berkeley J.PAUL GILMAN, Celera Genomics, Rockville, Maryland DANIEL S.GREENBAUM, Health Effects Institute, Cambridge, Massachusetts BRUCE D.HAMMOCK, University of California, Davis ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New Mexico CAROL HENRY, American Chemistry Council, Arlington, Virginia ROBERT HUGGETT, Michigan State University, East Lansing JAMES F.KITCHELL, University of Wisconsin, Madison DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario JAMES A.MACMAHON, Utah State University, Logan CHARLES O’MELIA, Johns Hopkins University, Baltimore, Maryland WILLEM F.PASSCHIER, Health Council of the Netherlands, The Hague ANN POWERS, Pace University School of Law, White Plains, New York KIRK SMITH, University of California, Berkeley TERRY F.YOSIE, American Chemistry Council, Arlington, Virginia Senior Staff JAMES J.REISA, Director DAVID J.POLICANSKY, Associate Director and Senior Program Director for Applied Ecology RAYMOND A.WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology ROBERTA M.WEDGE, Program Director for Risk Analysis JOHN HOLMES, Senior Staff Officer

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals COMMISSION ON LIFE SCIENCES MICHAEL T.CLEGG (Chair), University of California, Riverside 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 DAVID S.EISENBERG, University of California, Los Angeles NEAL L.FIRST, University of Wisconsin, Madison 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 COREY S.GOODMAN, University of California, Berkeley JON W.GORDON, Mount Sinai School of Medicine, New York DAVID G.HOEL, Medical University of South Carolina, Charleston BARBARA S.HULKA, University of North Carolina, Chapel Hill CYNTHIA J.KENYON, University of California, San Francisco 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 ROBERT T.PAINE, University of Washington, Seattle RONALD R.SEDEROFF, North Carolina State University, Raleigh ROBERT R.SOKAL, State University of New York, Stony Brook CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, California SHIRLEY M.TILGHMAN, Princeton University, Princeton, New Jersey RAYMOND L.WHITE, DNA Sciences, Inc., Mountain View, California 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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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY A Risk-Management Strategy for PCB-Contaminated Sediments (2001) Toxicological Effects of Methylmercury (2000) Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Modeling Mobile-Source Emissions (2000) Toxicological Risks of Selected Flame-Retardant Chemicals (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)

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals 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 (202) 334–3313 www.nap.edu

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) Acute Exposure Guideline Levels for Selected Airborne Contaminants, Volume 1 (2000) Review of the U.S. 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)

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Preface Extremely hazardous substances (EHSs)1 can be released accidentally as a result of chemical spills, industrial explosions, fires, or accidents involving railroad cars and trucks transporting EHSs. The people in communities surrounding industrial facilities where EHSs are manufactured, used, or stored and in communities along the nation’s railways and highways are potentially at risk of being exposed to airborne EHSs during accidental releases. Pursuant to the Superfund Amendments and Reauthorization Act of 1986, the U.S. Environmental Protection Agency (EPA) has identified approximately 400 EHSs on the basis of acute lethality data in rodents. As part of its efforts to develop acute exposure guideline levels for EHSs, EPA and the Agency for Toxic Substances and Disease Registry (ATSDR) requested that the National Research Council (NRC) in 1991 develop guidelines for establishing such levels. In response to that request, the NRC published Guidelines for Developing Community Emergency Exposure Levels for Hazardous Substances in 1993. Using the 1993 NRC guidelines report, the National Advisory Committee (NAC) on Acute Exposure Guideline Levels for Hazardous Substances—consisting of members from EPA, the Department of Defense (DOD), the Department of Energy (DOE), the Department of Transportation, other federal and state governments, the chemical industry, academia, and other organizations from the private sector—has developed acute exposure guideline levels (AEGLs) for approximately 80 EHSs. 1   As defined pursuant to the Superfund Amendments and Reauthorization Act of 1986.

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals In 1998, EPA and DOD requested that the NRC independently review the AEGLs developed by NAC. In response to that request, the NRC organized within its Committee on Toxicology the Subcommittee on Acute Exposure Guideline Levels, which prepared this report. This report evaluates the NAC’s Standing Operating Procedures (SOP) document for its scientific validity, completeness, and for conformance to the 1993 NRC guidelines report. The report will be useful to EPA, DOD, ATSDR, and other federal, state, and local agencies, and industry in developing toxicologic risk assessments for hazardous chemicals. This report has been reviewed in draft form 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 institution in making its 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 for their review of this report: Gary Carlson (Purdue University), Charles Feigley (University of South Carolina), and Ralph Kodell (National Center for Toxicological Research). 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 Mary Vore (University of Kentucky), appointed by the Commission on Life Sciences, who was 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. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. The subcommittee gratefully acknowledges the valuable assistance provided by the following persons: Roger Garrett, Paul Tobin, and Ernest Falke (all from EPA); George Rusch (Honeywell, Inc.); Po Yung Lu, Sylvia Talmage, Robert Young, and Cheryl Bast (all from Oak Ridge National Laboratory), and Karl Rozman (University of Kansas Medical Center). Aida Neel was the project assistant. Ruth Crossgrove edited the report. We are grateful to James J.Reisa, director of the Board on Environmental Studies and Toxicology (BEST), and David Policansky, associate director of BEST, for their helpful comments. The subcommittee particularly acknowledges Kulbir Bakshi, project director for the subcommittee, for bringing the report to

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals completion. Finally, we would like to thank all members of the subcommittee for their expertise and dedicated effort throughout the development of this report. Daniel Krewski, Chair Subcommittee on Acute Exposure Guideline Levels Bailus Walker, Chair Committee on Toxicology

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals Contents     INTRODUCTION   1     ROSTER OF THE NATIONAL ADVISORY COMMITTEE FOR ACUTE EXPOSURE GUIDELINE LEVELS (NAC/AEGL COMMITTEE) FOR HAZARDOUS SUBSTANCES   7     APPENDIX: STANDING OPERATING PROCEDURES FOR DEVELOPING ACUTE EXPOSURE GUIDELINE LEVELS FOR HAZARDOUS CHEMICALS   15     PREFACE   17 1.   OVERVIEW OF AEGL PROGRAM AND NAC/AEGL COMMITTEE   19      History,   19      Purpose and Objectives of the AEGL Program and the NAC/AEGL Committee,   21      Committee Membership and Organizational Structure,   23      Selection of Chemicals for AEGL Development,   24      Scientific Credibility of AEGL Values,   25      The AEGL Development and Peer-Review Process,   26      Operation of the NAC/AEGL Committee,   28      Value of a Collaborative Effort in the AEGL Program,   30      Applications of the AEGL Values,   31

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals 2.    DERIVATION OF AEGL VALUES    34       2.1    Characterization of AEGLs,    34       2.2    Empirical Toxicologic Endpoints and Methods for Determining Exposure Concentrations Used to Derive AEGLs 1, 2, and 3,    35       2.3    Guidelines and Criteria for the Search Strategy, Evaluation, Selection, and Documentation of Key Data and Supporting Data Used for the Derivation of AEGL Values,    46       2.4    Dosimetry Corrections from Animal to Human Exposures,    57       2.5    Guidelines and Criteria for Selection of Uncertainty Factors to Address the Variability Between Animals and Humans and Within the Human Population,    62       2.6    Guidelines and Criteria for Selection of Modifying Factors,    91       2.7    Guidelines and Criteria for Time Scaling,    92       2.8    Guidelines and Criteria for Addressing Short-Term Exposure Known and Suspect Carcinogens,    111       2.9    Guidelines and Criteria for Miscellaneous Procedures and Methods,    122 3.    FORMAT AND CONTENT OF TECHNICAL SUPPORT DOCUMENTS    124         Editorial Conventions,    124       3.1    Format and Content of Technical Support Documents,    125       3.2    Graphic Description of Data,    131 4.    CURRENT ADMINISTRATIVE PROCESSES AND PROCEDURES FOR THE DEVELOPMENT OF AEGL VALUES    139       4.1    Committee Membership and Organizational Structure,    140       4.2    The AEGL Development and Peer-Review Process,    141       4.3    Operation of the NAC/AEGL Committee,    144       4.4    Role of the Director of the AEGL Program,    146       4.5    Role of the Designated Federal Officer,    147       4.6    Role of the NAC/AEGL Committee Chair,    147       4.7    Classification of the Status of AEGL Values,    148       4.8    Function of AEGL Development Teams,    148       4.9    Role of NAC/AEGL Committee Members,    151       4.10    Role of the Organization That Drafts TSDs,    152 5.    REFERENCES    154 APPENDIX A.    PRIORITY LISTS OF CHEMICALS    165 APPENDIX B.    DIAGRAM OF THE AEGL DEVELOPMENT PROCESS    173

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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals APPENDIX C.   GLOSSARY OF ACRONYMS, ABBREVIATIONS, AND SYMBOLS   175 APPENDIX D.   EXAMPLE OF A TABLE OF CONTENTS OF A TECHNICAL SUPPORT DOCUMENT   179 APPENDIX E.   EXAMPLE OF A SUMMARY OF A TECHNICAL SUPPORT DOCUMENT   182 APPENDIX F.   EXAMPLE OF THE DERIVATION OF AEGL VALUES APPENDIX IN A TECHNICAL SUPPORT DOCUMENT   186 APPENDIX G.   EXAMPLE OF TIME-SCALING CALCULATIONS APPENDIX IN A TECHNICAL SUPPORT DOCUMENT   190 APPENDIX H.   EXAMPLE OF A CARCINOGENICITY ASSESSMENT APPENDIX IN A TECHNICAL SUPPORT DOCUMENT   194 APPENDIX I.   EXAMPLE OF THE AEGL DERIVATION SUMMARY APPENDIX IN A TECHNICAL SUPPORT DOCUMENT   196 APPENDIX J.   LIST OF EXTANT STANDARDS AND GUIDELINES IN A TECHNICAL SUPPORT DOCUMENT   201 LIST OF TABLES TABLE 2–1   Values of n from Ten Berge et al. (1986)   94 TABLE 3–1   Grouping Data into Categories for Plotting   132 TABLE A-1   Priority List of Chemicals   168 LIST OF FIGURES FIGURE 1–1   Hazard assessment   33 FIGURE 2–1   Decision tree for the selection of key and supporting data   55 FIGURE 2–2   Effects of varying n in the equation Cn×t=k   104 FIGURE 3–1   Plot of categories of data   137 FIGURE 4–1   The AEGL development process   142

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