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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels Committee on Acute Exposure Guideline Levels Committee on Toxicology Board on Environmental Studies and Toxicology NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by Contract Numbers W81K04-06-D-0023 and EP-W-09-007 between the National Academy of Sciences and the U.S. Department of Defense and the U.S Environmental Protection Agency. 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. This report is available online from the National Academies Press at http://www.nap.edu. 0-309-15139-2 Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels COMMITTEE ON ACUTE EXPOSURE GUIDELINE LEVELS Members DONALD E. GARDNER (Chair), Inhalation Toxicology Associates, Savannah, GA EDWARD C. BISHOP, HDR Inc., Omaha, NE LUNG CHI CHEN, New York University, Tuxedo, NY FREDERIK A. DE WOLFF, Leiden University Medical Center (retired), Leiden, Netherlands RAKESH DIXIT, MedImmune/AstraZeneca Biologics, Inc., Gaithersburg, MD JEFFREY W. FISHER, University of Georgia, Athens, GA FERNANDO HOLGUIN, University of Pittsburgh, Pittsburgh, PA DAVID P. KELLY, E. I. du Pont de Nemours & Company , Newark, DE MARGARET MACDONELL, Argonne National Laboratory, Argonne, IL DAVID A. MACYS, U.S. Department of the Navy (retired), Oak Harbor, WA FRANZ OESCH, University of Mainz, Mainz, Germany NU-MAY RUBY REED, California Environmental Protection Agency, Sacramento, CA GEORGE C. RODGERS JR., University of Louisville, Louisville, KY RICHARD B. SCHLESINGER, Pace University, New York, NY ROBERT SNYDER, Rutgers University, Piscataway, NJ Staff RAYMOND WASSEL, Senior Program Officer for Environmental Studies KEEGAN SAWYER, Associate Program Officer NORMAN GROSSBLATT, Senior Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects ORIN LUKE, Senior Program Assistant Sponsors U.S. DEPARTMENT OF DEFENSE U.S. ENVIRONMENTAL PROTECTION AGENCY
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels COMMITTEE ON TOXICOLOGY Members GARY P. CARLSON (Chair), Purdue University, West Lafayette, IN LAWRENCE S. BETTS, Eastern Virginia Medical School, Norfolk, VA EDWARD C. BISHOP, HDR Engineering, Inc., Omaha, NE JAMES V. BRUCKNER, University of Georgia, Athens, GA MARION F. EHRICH, Virginia Polytechnic Institute and State University, Blacksburg, VA SIDNEY GREEN, Howard University, Washington, DC WILLIAM E. HALPERIN, UMDNJ–New Jersey Medical School, Newark, NJ MERYL H. KAROL, University of Pittsburgh, Pittsburgh, PA JAMES N. MCDOUGAL, Wright State University School of Medicine, Dayton, OH ROGER G. MCINTOSH, Science Applications International Corporation, Abingdon, MD GERALD N. WOGAN, Massachusetts Institute of Technology, Cambridge, MA Staff SUSAN N. J. MARTEL, Senior Program Officer for Toxicology EILEEN N. ABT, Senior Program Officer for Risk Analysis ELLEN K. MANTUS, Senior Program Officer MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects TAMARA DAWSON, Program Associate
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members ROGENE F. HENDERSON (Chair), Lovelace Respiratory Research Institute, Albuquerque, NM RAMÓN ALVAREZ, Environmental Defense Fund, Austin, TX TINA BAHADORI, American Chemistry Council, Arlington, VA MICHAEL J. BRADLEY, M.J. Bradley & Associates, Concord, MA DALLAS BURTRAW, Resources for the Future, Washington, DC JAMES S. BUS, Dow Chemical Company, Midland, MI JONATHAN Z. CANNON, University of Virginia, Charlottesville GAIL CHARNLEY, HealthRisk Strategies, Washington, DC RUTH DEFRIES, Columbia University, New York, NY RICHARD A. DENISON, Environmental Defense Fund, Washington, DC H. CHRISTOPHER FREY, North Carolina State University, Raleigh J. PAUL GILMAN, Covanta Energy Corporation, Fairfield, NJ RICHARD M. GOLD, Holland & Knight, LLP, Washington, DC LYNN R. GOLDMAN, Johns Hopkins University, Baltimore, MD JUDITH A. GRAHAM (retired), Pittsboro, NC HOWARD HU, University of Michigan, Ann Harbor ROGER E. KASPERSON, Clark University, Worcester, MA TERRY L. MEDLEY, E. I. du Pont de Nemours & Company, Wilmington, DE JANA MILFORD, University of Colorado at Boulder, Boulder DANNY D. REIBLE, University of Texas, Austin JOSEPH V. RODRICKS, ENVIRON International Corporation, Arlington, VA ROBERT F. SAWYER, University of California, Berkeley KIMBERLY M. THOMPSON, Harvard School of Public Health, Boston, MA MARK J. UTELL, University of Rochester Medical Center, Rochester, NY Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Scholar RAYMOND A. WASSEL, Senior Program Officer for Environmental Studies SUSAN N.J. MARTEL, Senior Program Officer for Toxicology ELLEN K. MANTUS, Senior Program Officer for Risk Analysis EILEEN N. ABT, Senior Program Officer RUTH E. CROSSGROVE, Senior Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects 1 This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Hidden Costs of Energy: Unpriced Consequences of Energy Production and Use (2009) Contaminated Water Supplies at Camp Lejeune—Assessing Potential Health Effects (2009) Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (2009) Science and Decisions: Advancing Risk Assessment (2009) Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2008) Estimating Mortality Risk Reduction and Economic Benefits from Controlling Ozone Air Pollution (2008) Respiratory Diseases Research at NIOSH (2008) Evaluating Research Efficiency in the U.S. Environmental Protection Agency (2008) Hydrology, Ecology, and Fishes of the Klamath River Basin (2008) Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment (2007) Models in Environmental Regulatory Decision Making (2007) Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007) Sediment Dredging at Superfund Megasites: Assessing the Effectiveness (2007) Environmental Impacts of Wind-Energy Projects (2007) Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007) Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006) New Source Review for Stationary Sources of Air Pollution (2006) Human Biomonitoring for Environmental Chemicals (2006) Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006) Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006) State and Federal Standards for Mobile-Source Emissions (2006) Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005) Health Implications of Perchlorate Ingestion (2005) Air Quality Management in the United States (2004) Endangered and Threatened Species of the Platte River (2004) Atlantic Salmon in Maine (2004) Endangered and Threatened Fishes in the Klamath River Basin (2004) Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003) Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002) Biosolids Applied to Land: Advancing Standards and Practices (2002) The Airliner Cabin Environment and Health of Passengers and Crew (2002) Arsenic in Drinking Water: 2001 Update (2001) Evaluating Vehicle Emissions Inspection and Maintenance Programs (2001) Compensating for Wetland Losses Under the Clean Water Act (2001) A Risk-Management Strategy for PCB-Contaminated Sediments (2001) Acute Exposure Guideline Levels for Selected Airborne Chemicals (seven volumes, 2000-2009) Toxicological Effects of Methylmercury (2000) Strengthening Science at the U.S. Environmental Protection Agency (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (2000) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter (four volumes, 1998-2004) The National Research Council’s Committee on Toxicology: The First 50 Years (1997)
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels 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 (five volumes, 1989-1995) Science and Judgment in Risk Assessment (1994) Pesticides in the Diets of Infants and Children (1993) Dolphins and the Tuna Industry (1992) Science and the National Parks (1992) Human Exposure Assessment for Airborne Pollutants (1991) Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991) Decline of the Sea Turtles (1990) Copies of these reports may be ordered from the National Academies Press (800) 624-6242 or (202) 334-3313 www.nap.edu
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Combined Exposures to Hydrogen Cyanide and Carbon Monoxide in Army Operations: Final Report (2008) Managing Health Effects of Beryllium Exposure (2008) Review of Toxicologic and Radiologic Risks to Military Personnel from Exposures to Depleted Uranium (2008) Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants, Volume 1 (2007), Volume 2 (2008) Review of the Department of Defense Research Program on Low-Level Exposures to Chemical Warfare Agents (2005) Review of the Army’s Technical Guides on Assessing and Managing Chemical Hazards to Deployed Personnel (2004) Spacecraft Water Exposure Guidelines for Selected Contaminants, Volume 1 (2004), Volume 2 (2007), Volume 3 (2008) Toxicologic Assessment of Jet-Propulsion Fuel 8 (2003) Review of Submarine Escape Action Levels for Selected Chemicals (2002) Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals (2001) Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity (2001) Acute Exposure Guideline Levels for Selected Airborne Contaminants, Volume 1 (2000), Volume 2 (2002), Volume 3 (2003), Volume 4 (2004), Volume 5 (2007), Volume 6 (2008), Volume 7 (2009), Volume 8 (2009) 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), Volume 5 (2008)
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels Preface Extremely hazardous substances (EHSs)2 can be released intentionally through terrorist activities or accidentally as a result of chemical spills, industrial explosions, fires, or accidents involving railroad cars or trucks transporting EHSs. EHSs can also be released because of improper storage or handling. Workers and residents 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 for exposure to airborne EHSs during accidental or intentional releases. Pursuant to the Superfund Amendments and Reauthorization Act of 1986, the U.S. Environmental Protection Agency (EPA) has identified some 400 EHSs on the basis of data on acute lethality 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) in 1991 requested that the National Research Council develop guidelines for establishing such levels. In response to that request, the National Research Council published Guidelines for Developing Community Emergency Exposure Levels for Hazardous Substances in 1993. Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Substances, published in 2001, provided updated procedures, methods, and other guidelines used by the National Advisory Committee (NAC) on Acute Exposure Guideline Levels for Hazardous Substances and the National Research Council Committee on Acute Exposure Guideline Levels (AEGLs) in developing the AEGL values. Using the 1993 and 2001 National Research Council guidelines reports, the NAC—consisting of members in EPA, the Department of Defense (DOD), the Department of Energy (DOE), the Department of Transportation (DOT), other federal and state governments, the chemical industry, academe, and other organizations in the private sector—has developed AEGLs for about 200 EHSs. In 1998, EPA and DOD requested that the National Research Council independently review the AEGLs developed by the NAC. In response to that request, the National Research Council organized within its Committee on Toxicology the Committee on Acute Exposure Guideline Levels, which prepared the present report. At its meetings, the committee hears presentations from NAC staff and its contractors on draft AEGL documents. At some meetings, the committee also hears presentations from the NAC’s collaborators in other countries, such Germany and the Netherlands. The committee provides comments and recommendations on those documents to the NAC in its interim reports, and the NAC uses the comments to make revisions. The revised documents are presented to the committee by the NAC at later meetings until the committee concurs with the final draft documents. The revised documents are then published as appendixes in the committee’s reports. The present report is the committee’s 17th interim report. It summarizes the committee’s conclusions and recommendations for improving the NAC’s AEGL documents for 17 chemicals: acetaldehyde, arsenic trioxide, benzene, 1,3-butadiene, butane, chloroacetaldehyde, chlorobenzene, hexane, jet propellant fuels 5 and 8, ketene, methylene chloride, oleum, propane, propionaldehyde, 2 As defined pursuant to the Superfund Amendments and Reauthorization Act of 1986.
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels sulfuric acid, sulfur trioxide, and trichloroethylene. The report also summarizes the committee’s conclusions and recommendations for improving the Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Substances, published in 2001. Committee member Robert Snyder recused himself from discussion of the draft AEGL document for benzene. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council Report Review Committee. The purpose of the independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and ensuring that the report meets institutional standards of 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 thank the following for their review of this report: Harvey Clewell, The Hamner Institutes for Health Sciences; Sammuel Kacew, University of Ottawa; and Kenneth Still, Occupational Toxicology Associates. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by Robert Goyer, University of Western Ontario. Appointed by the National Research Council, he was responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the author committee and the National Research Council. The committee gratefully acknowledges the valuable assistance provided by the following: Iris Camacho and Ernest Falke, EPA; Sylvia Talmage, consultant to EPA; and Peter Bos, Joanne Nijhof, and Marcel van Raaij, the National Institute for Public Health and the Environment of the Netherlands. The committee acknowledges James J. Reisa, director of the Board on Environmental Studies and Toxicology, for his helpful guidance and Raymond Wassel, project director, for his work on this project. Other staff members who contributed to this effort are Keegan Sawyer (associate program officer), Norman Grossblatt (senior editor), Mirsada Karalic-Loncarevic (manager, Technical Information Center), Radiah Rose (manager, Editorial Projects), and Orin Luke (senior program assistant). Finally, I thank all members of the committee for their expertise and dedicated effort throughout the development of this report. Donald E. Gardner, Chair Committee on Acute Exposure Guideline Levels
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Seventeenth Interim Report of the Committee on Acute Exposure Guideline Levels Contents BACKGROUND 1 THE CHARGE TO THE COMMITTEE 1 COMMENTS ON ACETALDEHYDE 2 COMMENTS ON ARSENIC TRIOXIDE 5 COMMENTS ON BENZENE 12 COMMENTS ON 1,3-BUTADIENE 16 COMMENTS ON BUTANE 20 COMMENTS ON CHLOROACETALDEHYDE 21 COMMENTS ON CHLOROBENZENE 23 COMMENTS ON HEXANE 26 COMMENTS ON JET PROPELLANT FUELS 5 AND 8 28 COMMENTS ON KETENE 29 COMMENTS ON METHYLENE CHLORIDE 33 COMMENTS ON PROPANE 40 COMMENTS ON PROPIONALDEHYDE 42 COMMENTS ON SULFURIC ACID, SULFUR TRIOXIDE, AND OLEUM 47 COMMENTS ON TRICHLOROETHYLENE 50 COMMENTS ON STANDING OPERATING PROCEDURES 54 ABBREVIATIONS 55
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