PESTICIDES in the DIETS OF INFANTS AND CHILDREN

Committee on Pesticides in the Diets of Infants and Children

Board on Agriculture and Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.
1993



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Pesticides in the Diets of Infants and Children PESTICIDES in the DIETS OF INFANTS AND CHILDREN Committee on Pesticides in the Diets of Infants and Children Board on Agriculture and Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1993

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Pesticides in the Diets of Infants and Children NATIONAL ACADEMY PRESS 2101 Constitution Avenue Washington, DC 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. Support for this project was provided by the U.S. Environmental Protection Agency, Contract No. 68D-80101, with contributions from International Life Sciences Institute and Health and Welfare Canada. In addition, support for this project was provided by the Kellogg Endowment Fund of the National Academy of Sciences and the Institute of Medicine. Library of Congress Cataloging-in-Publication Data National Research Council (U.S.). Committee on Pesticides in the Diets of Infants and Children. Pesticides in the diets of infants and children/Committee on Pesticides in the Diets of Infants and Children, Board on Agriculture and Board on Environmental Studies and Toxicology, Commission on Life Sciences, National Research Council. p. cm. Includes bibliographical references and index. ISBN 0-309-04875-3 1. Pediatric toxicology. 2. Pesticide residues in food—United States. 3. Pesticides—Toxicology. 4. Infant formulas—Contamination. 5. Food contamination. I. Title. [DNLM: 1. Pesticides. 2. Diet—in infancy & childhood. 3. Food Contamination. WS 115 N277p 1993] RA1225.N38 1993 615.9'54—dc20 DNLM/DLC for Library of Congress Copyright 1993 by the National Academy of Sciences. All rights reserved. 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. Additional copies of this book are available from the National Academy Press, 2101 Constitution Avenue, NW, Box 285, Washington, DC 20055. Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area). Printed in the United States of America First Printing, June 1993 Second Printing, August 1993 Third Printing, November 1993 Fourth Printing, September 1997

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Pesticides in the Diets of Infants and Children COMMITTEE ON PESTICIDES IN THE DIETS OF INFANTS AND CHILDREN PHILIP J. LANDRIGAN, Chair, Mount Sinai School of Medicine, New York DONALD R. MATTISON, Vice-Chair, Graduate School of Public Health, University of Pittsburgh, Pittsburgh HARVEY J. BABICH, Rockefeller University and Yeshiva University, New York BARBARA BOARDMAN, Boston University Medical School and Boston City Hospital Pediatrics, Boston JAMES V. BRUCKNER, University of Georgia, Athens MICHAEL A. GALLO, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway DONALD E. HUTCHINGS, New York State Psychiatric Institute, New York RICHARD J. JACKSON, California State Department of Health Services, Berkeley MERYL H. KAROL, Graduate School of Public Health, University of Pittsburgh, Pittsburg DANIEL KREWSKI, Health and Welfare Canada, Ottawa, Ontario GEORGE A. PURVIS, Gerber Products Company, Fremont, Mich. ROBERT L. RIZEK, U.S. Department of Agriculture, Hyattsville, Md. JAMES N. SEIBER, University of Nevada, Reno WILLIAM B. WEIL, Michigan State University, East Lansing Staff FRANCES M. PETER, Project Manager RICHARD D. THOMAS, Principal Staff Scientist (BEST) CRAIG A. COX, Senior Staff Officer (BA) SANDRA S. FITZPATRICK, Senior Program Assistant (BEST) SHELLEY A. NURSE, Senior Project Assistant (BEST) RUTH P. DANOFF, Project Assistant (BEST)

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Pesticides in the Diets of Infants and Children Technical Advisers EMMANUEL AKPANYIE, Environmental Systems International, Vienna, Va. SHERYL BARTLETT, Health and Welfare Canada, Ottawa, Ontario JUDY HAUSWIRTH, Jellinek, Schwartz, Connolly and Freshman, Washington, D.C. JOHN P. WARGO, Yale University, New Haven, Conn. RICHARD WILES, Center for Resource Economics, Washington, D.C.

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Pesticides in the Diets of Infants and Children BOARD ON AGRICULTURE THEODORE L. HULLAR, Chair, University of California, Davis PHILIP H. ABELSON, American Association for the Advancement of Science, Washington, D.C. JOHN M. ANTLE, Montana State University, Bozeman DALE E. BAUMAN, Cornell University, Ithaca, N.Y. WILLIAM B. DeLAUDER, Delaware State College, Dover SUSAN K. HARLANDER, Land O'Lakes, Inc., Minneapolis, Minn. PAUL W. JOHNSON, Natural Resources Consultant, Decorah, Iowa T. KENT KIRK, U.S. Department of Agriculture, Forest Service, Madison, Wis. JAMES R. MOSELEY, Purdue University, West Lafayette, Ind. DONALD R. NIELSEN, University of California, Davis NORMAN R. SCOTT, Cornell University, Ithaca, N.Y. GEORGE E. SEIDEL, JR., Colorado State University, Fort Collins PATRICIA B. SWAN, Iowa State University, Ames JOHN R. WELSER, The Upjohn Company, Kalamazoo, Mich. FREDERIC WINTHROP, JR., The Trustees of Reservations, Beverly, Mass Staff SUSAN E. OFFUTT, Executive Director JAMES E. TAVARES, Associate Executive Director CARLA CARLSON, Director of Communications BARBARA J. RICE, Editor JANET OVERTON, Associate Editor

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Pesticides in the Diets of Infants and Children BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY PAUL G. RISSER, Chair, University of Miami, Oxford, Ohio FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. JOHN C. BAILAR III, McGill University School of Medicine, Montreal, Quebec, Canada GARRY D. BREWER, University of Michigan, Ann Arbor, Mich. JOHN CAIRNS, JR., Virginia Polytechnic Institute and State University, Blacksburg, Va. EDWIN H. CLARK, Department of Natural Resources and Environmental Control, State of Delaware, Dover, Del. JOHN L. EMMERSON, Lilly Research Laboratories, Greenfield, Ind. ROBERT C. FORNEY, Unionville, Pa. ALFRED G. KNUDSON, Fox Chase Cancer Center, Philadelphia, Pa. KAI LEE, Williams College, Williamstown, Mass. GENE E. LIKENS, The New York Botanical Garden, Millbrook, N.Y. JANE LUBCHENCO, Oregon State University, Corvallis, Oreg. DONALD MATTISON, University of Pittsburgh, Pittsburgh, Pa. HAROLD A. MOONEY, Stanford University, Stanford, Calif. GORDON ORIANS, University of Washington, Seattle, Wash. FRANK L. PARKER, Vanderbilt University, Nashville, Tenn., and Clemson University, Anderson, S.C. GEOFFREY PLACE, Hilton Head, S.C. MARGARET M. SEMINARIO, AFL/CIO, Washington, D.C. I. GLENN SIPES, University of Arizona, Tucson, Ariz. BAILUS WALKER, JR., University of Oklahoma, Oklahoma City, Okla. WALTER J. WEBER, JR., University of Michigan, Ann Arbor, Mich. Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director and Program Director for Natural Resources and Applied Ecology RICHARD D. THOMAS, Associate Director and Program Director for Human Toxicology and Risk Assessment LEE R. PAULSON, Program Director for Information Systems and Statistics RAYMOND A. WASSEL, Program Director for Environmental Sciences and Engineering

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Pesticides in the Diets of Infants and Children COMMISSION ON LIFE SCIENCES THOMAS D. POLLARD, Chair, Johns Hopkins Medical School, Baltimore, Md. BRUCE N. AMES, University of California, Berkeley, Calif. J. MICHAEL BISHOP, Hooper Research Foundation, University of California Medical Center, San Francisco, Calif. DAVID BOTSTEIN, Stanford University School of Medicine, Stanford, Calif. MICHAEL T. CLEGG, University of California, Riverside, Calif. GLENN A. CROSBY, Washington State University, Pullman, Wash. LEROY E. HOOD, University of Washington, Seattle, Wash. MARIAN E. KOSHLAND, University of California, Berkeley, Calif. RICHARD E. LENSKI, University of Oxford, Oxford, United Kingdom STEVEN P. PAKES, Southwestern Medical Center, Dallas, Tex. EMIL A. PFITZER, Hoffmann-La Roche Inc., Nutley, N.J. MALCOLM C. PIKE, University of Southern California School of Medicine, Los Angeles, Calif. PAUL G. RISSER, Miami University, Oxford, Ohio JOHNATHAN M. SAMET, University of New Mexico School of Medicine, Albuquerque, N. Mex. HAROLD M. SCHMECK, JR., Armonk, N.Y. CARLA J. SHATZ, University of California, Berkeley, Calif. SUSAN S. TAYLOR, University of California at San Diego, La Jolla, Calif. P. ROY VAGELOS, Merck and Company, Inc., Whitehouse Station, N.J. TORSTEN N. WIESEL, Rockefeller University, New York, N.Y. Staff PAUL GILMAN, Executive Director

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Pesticides in the Diets of Infants and Children 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. Frank Press 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. Robert M. White 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. Frank Press and Dr. Robert M. White are chairman and vice-chairman, respectively, of the National Research Council.

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Pesticides in the Diets of Infants and Children Preface IN 1988, THE U.S. CONGRESS requested that the National Academy of Sciences establish a committee within the National Research Council to study scientific and policy issues concerning pesticides in the diets of infants and children. The Committee on Pesticide Residues in the Diets of Infants and Children appointed to undertake this study was charged with responsibility for examining what is known about exposures to pesticide residues in the diets of infants and children, the adequacy of current risk assessment methods and policies, and toxicological issues of greatest concern. The committee operated under the joint aegis of the Board on Agriculture (BA) and the Board on Environmental Studies and Toxicology (BEST). The committee first met in October 1988 and held its last meeting in January 1993. Several full committee meetings were held each year, and subgroups of the committee were convened on a number of occasions to address such topics as the physiology of infants and children, the age-specific patterns of children's diets, the measurement of residue levels, and the mathematical modeling of risks. The expertise represented on the committee included pediatrics, toxicology, epidemiology, biostatistics, food science and nutrition, analytical chemistry, and child growth and development. When required, advice was obtained from experts outside the committee on a variety of topics. Critical assessment of potential risks to health resulting from exposures to toxicants in the environment has been the focus of several recent studies conducted by BEST and BA. Many of the approaches to risk assessment used in this report trace their origins to the reports on Drinking Water and

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Pesticides in the Diets of Infants and Children Health developed since 1977. Of particular value was Volume 6 in that series. The committee also found useful Risk Assessment in the Federal Government: Managing the Process (1983), Biologic Markers in Reproductive Toxicology (1989), Biologic Markers in Immunotoxicology (1992), and Environmental Neurotoxicology (1992). The analysis in this volume draws conceptually from the 1987 report from the Board on Agriculture called Regulating Pesticides in Food: The Delaney Paradox—an examination of the process by which levels of pesticide residues in foods are regulated by the U.S. Government. The Committee on Pesticides in the Diets of Infants and Children was greatly assisted by many individuals and groups who provided information on food consumption patterns and on pesticide residue concentrations in the U.S. diet. The groups include the U.S. Department of Agriculture, the U.S. Food and Drug Administration, the National Food Processors Association, the Gerber Products Company, and the Infant Formula Council. Many other food manufactures as well as pesticide manufacturers also provided useful data to the committee either individually or through various organizations. The committee is grateful for the assistance of the National Research Council (NRC) staff in the preparation of this report. In particular the committee wishes to acknowledge Frances Peter, project manager; Richard Thomas, principal staff scientist (BEST); Sandi Fitzpatrick, senior program assistant (BEST); James Reisa, director of BEST; and Susan Offutt, executive director of BA. Other staff members who contributed to this effort include Shelley A. Nurse, senior project assistant (BEST); Ruth P. Danoff, project assistant (BEST); Craig Cox, senior staff officer (BA); Mary Lou Sutton, administrative assistant (BA); Carla Carlson, director of communications (BA); Barbara J. Rice, editor (BA); Janet Overton, associate editor (BA); Lee. R. Paulson, program director for information systems and statistics (BEST); Bernidean Williams, information specialist (BEST); and Dawn M. Eichenlaub, production manager, and Richard E. Morris, editor, National Academy Press. Thanks are also due to Richard Wiles and Charles Benbrook, formerly of the BA staff. The interest in this report shown by the Executive Office of the National Research Council, especially by the Deputy Executive Officer Mitchel Wallerstein, is greatly appreciated. These individuals provided invaluable support to the committee throughout its deliberations. As consultant to the committee, John Wargo of the Yale University School of Forestry and Environmental Studies developed numerous innovative approaches to the analysis of highly complex data. His pellucid presentations permitted clear understanding of issues that previously had been opaque. Valuable assistance was also provided to the committee by Emmanuel Akpanyie, Sheryl Bartlett, and Judy Hauswirth, who served as technical advisers, and Dr. Marcia VanGemert, the EPA project officer.

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Pesticides in the Diets of Infants and Children Last, but by no means least, the work of all the members of the committee is greatly appreciated. We are also grateful to the U. S. Environmental Protection Agency, Health and Welfare Canada, the International Life Sciences Institute, and the Kellogg Endowment Fund of the National Academy of Sciences and the Institute of Medicine, whose financial support made the study possible. PHILIP J. LANDRIGAN, M.D., M.Sc. Chairman

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Pesticides in the Diets of Infants and Children Contents     EXECUTIVE SUMMARY   1 1   BACKGROUND AND APPROACH TO THE STUDY   13     Pesticide Use   14     Pesticide Control Legislation   17     Approach to the Study   18     References   22 2   SPECIAL CHARACTERISTICS OF CHILDREN   23     Growth   25     Development   36     Conclusions and Recommendations   42     References   44 3   PERINATAL AND PEDIATRIC TOXICITY   49     Acute Toxicity   49     Neurotoxicity   60     Immunotoxicity   66     Carcinogenesis and Mutagenesis   70     Metabolism and Pharmacokinetics   76

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Pesticides in the Diets of Infants and Children     Scaling and Progression Analysis   96     Conclusions and Recommendations   105     References   110 4   METHODS FOR TOXICITY TESTING   127     Current Methods: General Considerations   128     Acute Toxicity Studies   133     Subchronic Toxicity Studies   137     Chronic Toxicity Studies   145     Developmental Toxicity Studies   146     Reproduction Studies   147     Mutagenicity Studies   150     General Metabolism Studies   150     Neurotoxicity Studies   151     Special Testing   152     Conclusions and Recommendations   152     References   156 5   FOOD AND WATER CONSUMPTION   159     Food Consumption Surveys   159     Survey Methodology   161     Survey Design   164     Sample Weights   167     Sample Size   167     Comparisons of Intake Data with Standards   167     Validation of Food Consumption Data   168     The Strengths and Weaknesses of the Food Consumption Data Bases in Estimating Pesticide Exposure of Children   169     Water Intake   172     Quantification of Consumption Data   177     Age-Related Differences in Dietary Patterns   181     Issues Related to the Evaluation of Food Monitoring Data   194     Conclusions and Recommendations   195     References   197 6   PESTICIDE RESIDUES   203     Sources of Data on Usage   203

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Pesticides in the Diets of Infants and Children     The Occurrence and Fate of Pesticide Residues   206     Pesticide Registration and the Development of Analytical Methods   207     Methods for Sampling and Analysis   210     Monitoring   215     Quality Controls   223     Limitations of the Data   224     Pesticides in Water   227     Pesticides in Infant Formula   232     Pesticides in Human Milk   239     Pesticides in Foods   244     Conclusions and Recommendations   260     References   263 7   ESTIMATING EXPOSURES   267     The Use of Food Consumption and Residue Data for Exposure Assessment   270     Long-Term Exposure to Benomyl   277     Short-Term Exposure to Aldicarb   287     Multiple Exposure Assessment: Organophosphate Insecticides   297     Nondietary Exposure to Pesticides   307     Conclusions and Recommendations   314     References   319 8   ESTIMATING THE RISKS   323     General Principles of Risk Assessment   324     Risk Assessments for Infants and Children   339     Conclusions and Recommendations   359     References   363     INDEX   373