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i Tenth Interim Report of the Subcommittee on Acute Exposure Guideline Levels Subcommittee on Acute Exposure Guideline Levels Committee on Toxicology Board on Environmental Studies and Toxicology Division on Earth and Life Studies NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu
ii NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, D.C. 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose mem- bers 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. DAMD 17-89-C-9086 and DAMD17-99-C-9049 between the National Academy of Sci- ences and the U.S. Army. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Additional copies of this report are available from: The National Academies Press 500 Fifth Street, NW Box 285 Washington, DC 20055 800â624â6242 202â334â3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2004 by the National Academy of Sciences. All rights reserved. Printed in the United States of America
iii 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 Acade my 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. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the 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 Academyâs 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. Wm. A. Wulf are chairman and vice chairman, respectively, of the National Research Council. www.national-academies.org
v SUBCOMMITTEE ON ACUTE EXPOSURE GUIDELINE LEVELS DANIEL KREWSKI (Chair), University of Ottawa, Ottawa, Ontario EDWARD C.BISHOP, Parsons Corporation, Pasadena, CA JAMES V.BRUCKNER, University of Georgia, Athens DAVID P.KELLY, Dupont Company, Newark, DE KANNAN KRISHNAN, University of Montreal, Montreal, Quebec STEPHEN U.LESTER, Center for Health, Environment, and Justice, Falls Church, VA JUDITH MAC GREGOR, Toxicology Consulting Services, Arnold, MD PATRICIA M.MCGINNIS, Syracuse Research Corporation, Ft. Washington, PA FRANZ OESCH, University of Mainz, Mainz, Germany RICHARD B.SCHLESINGER, Pace University, New York, NY CALVIN C.WILLHITE, State of California, Berkeley FREDERIK A.DE WOLFF , Leiden University Medical Center, Leiden, Netherlands Staff KULBIR S.BAKSHI, Project Director RUTH CROSSGROVE, Editor AIDA C.NEEL, Senior Project Assistant Sponsor U.S. DEPARTMENT OF DEFENSE
vi COMMITTEE ON TOXICOLOGY BAILUS WALKER, JR. (Chair), Howard University Medical Center and American Public Health Association, Washington, DC MELVIN E.ANDERSEN, CIIT-Centers for Health Research, Research Triangle, Park, NC EDWARD C.BISHOP, Parsons Corporation, Pasadena, CA GARY P.CARLSON, Purdue University, West Lafayette, IN JANICE E.CHAMBERS, Mississippi State University, Mississippi State LEONARD CHIAZZE, J R., Georgetown University, Washington, DC JUDITH A.GRAHAM, American Chemistry Council, Arlington, VA SIDNEY GREEN, Howard University, Washington, DC MERYL KAROL, University of Pittsburgh, Pittsburgh, PA STEPHEN U.LESTER, Center for Health Environment and Justice, Falls Church, VA DAVID H.MOORE, Battelle Memorial Institute, Bel Air, MD CALVIN C.WILLHITE, Department of Toxic Substances, State of California, Berkeley GERALD N.WOGAN, Massachusetts Institute of Technology, Cambridge Staff KULBIR S.BAKSHI, Program Director ROBERTA M.WEDGE, Program Director for Risk Analysis SUSAN N.J.MARTEL, Senior Staff Officer ELLEN K.MANTUS, Senior Staff Officer KELLY CLARK, Assistant Editor AIDA NEEL, Senior Project Assistant TAMARA DAWSON, Project Assistant
vii BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members JONATHAN SAMET (Chair), Johns Hopkins University, Baltimore, MD DAVID ALLEN, University of Texas, Austin THOMAS BURKE, Johns Hopkins University, Baltimore, MD JUDITH C.CHOW, Desert Research Institute, Reno, NV COSTEL D.DENSON, University of Delaware, Newark E.DONALD ELLIOTT, Willkie, Farr & Gallagher, LLP, Washington, DC CHRISTOPHER B.FIELD, Carnegie Institute of Washington, Stanford, CA WILLIAM H.G LAZE, Oregon Health & Sciences University, Beaverton SHERRI W.GOODMAN, Center for Naval Analyses, Alexandria, VA DANIEL S.GREENBAUM, Health Effects Institute, Cambridge, MA ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, NM CAROL HENRY, American Chemistry Council, Arlington, VA ROBERT HUGGETT, Michigan State University, East Lansing BARRY L.J OHNSON, Emory University, Atlanta, GA JAMES H.JOHNSON, JR., Howard University, Washington, DC JUDITH L.M EYER, University of Georgia, Athens PATRICK V.O'BRIEN, Chevron Research and Technology, Richmond, CA DOROTHY E.PATTON, International Life Sciences Institute, Washington, DC STEWARD T.A.PICKETT, Institute of Ecosystems Studies, Millbrook, NY ARMISTEAD G.RUSSELL, Georgia Institute of Technology, Atlanta LOUISE M.R YAN, Harvard University, Boston, MA KIRK SMITH, University of California, Berkeley LISA SPEER , Natural Resources Defense Council, New York, NY G.DAVID T ILMAN, University of Minnesota, St. Paul CHRIS G.WHIPPLE, Environ, Inc., Emeryville, CA LAUREN A.ZEISE, California Environmental Protection Agency, Oakland Senior Staff JAMES J.REISA, Director DAVID J.POLICANSKY, Associate Director RAYMOND A.WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR B AKSHI, Program Director for Toxicology ROBERTA M.WEDGE, Program Director for Risk Analysis K.JOHN HOLMES, Senior Staff Officer SUSAN N.J.MARTEL, Senior Staff Officer SUZANNE VAN DRUNICK, Senior Staff Officer EILEEN N.ABT, Senior Staff Officer ELLEN K.MANTUS, Senior Staff Officer RUTH E.CROSSGROVE, Managing Editor 1This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.
PREFACE ix PREFACE Extremely hazardous substances (EHSs)1 can be released accidentally as a result of chemical spills, industrial explosions, fires, or accidents involving railroad cars or trucks transporting EHSs, or intentionally through terrorist activities. 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 of being exposed to airborne EHSs during accidental and intentional 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. The National Advisory Committee (NAC) on Acute Exposure Guideline Levels for Hazardous Substances has developed acute exposure guideline levels (AEGLs) for approximately 100 EHSs to date. In 1998, EPA and the U.S. Department of Defense (DOD) requested that the National Research Council (NRC) independently review the AEGLs developed by the NAC. In response to that request, the NRC organized within its Committee on Toxicology the Subcommittee on Acute Exposure Guideline Levels. The NAC's Standing Operating Procedures for Developing AEGLs for Airborne Chemicals was reviewed by the subcommittee and published in May 2001. That report provides step-by-step guidance for the derivation of AEGLs for hazardous chemicals. In December 2000, the subcommittee's first report, Acute Exposure Guideline Levels for Selected Airborne Chemicals, Volume 1, was published by the NRC; volumes 2 and 3 in that series were published in 2002 and 2003, respectively. The subcommittee meets two to three times each calendar year. At those meetings, the subcommittee hears presentations from the NAC staff and its contractorâthe Oak Ridge National Laboratoryâon draft AEGL documents. At some meetings, the subcommittee also hears presentations from NAC's collaborators from other countries, such as Germany. The subcommittee provides comments and recommendations on those documents to NAC in its interim reports, and the NAC uses those comments to make revisions. The revised reports are presented by the NAC to the subcommittee at subsequent meetings until the subcommittee concurs with the final draft documents. The revised reports are then published as appendixes in the subcommittee's reports. The present report is the subcommittee's tenth interim report. It summarizes the subcommittee's conclusions and recommendations for improving NAC's AEGL documents for 17 chemicals: Hydrazine, ethylene oxide, propylene oxide, iron pentacarbonyl, nickel carbonyl, phosphine, boron trichloride, chlorine trifluoride, dichlorodiemthyl silane, trichloromethyl silane, ethylenimine, propylenimine, allyl alcohol, aniline, arsine, monomethylhydrazine, and dimethylhydrazine. 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 1As defined pursuant to the Superfund Amendments and Reauthorization Act of 1986.
PREFACE x 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: Sidney Green of Howard University, Charles Reinhardt (retired) of DuPont Haskell Laboratory, and Bernard M.Wagner of New York University Medical Center. 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: David H.Moore of Battelle Memorial Institute. Appointed by the National Research Council, he 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: Ernest Falke and Paul Tobin (both from EPA); Cheryl Bast, Kowetha Davidson, Po Yung Lu, Sylvia Milanez, Sylvia Talmage, Claudia Troxel, Annetta Watson, and Robert Young (all from Oak Ridge National Laboratory). Aida Neel was the project assistant and Ruth Crossgrove was the editor. We are grateful to James J.Reisa, director of the Board on Environmental Studies and Toxicology, for his helpful guidance. The subcommittee particularly acknowledges Kulbir Bakshi, project director for the subcommittee, for bringing the report to 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