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REGULATING PESTICIDES IN FOOD THE DELANEY PARA1)OX Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation Board on Agriculture National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1987

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NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW 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. 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. Samuel O. Thier 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 of 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. This project was supported by the U.S. Environmental Protection Agency. Although the research described in this document has been funded wholly or in part by the U.S. Environmental Protection Agency under assistance agreement CR-812181-01 to the National Academy of Sciences, it has not been subjected to the agency's peer and administrative review and therefore may not necessarily reflect the views of the agency, and no official endorsement should be inferred. Preparation of this publication was supported by funds from the W. K. Kellogg Foundation; Dow Chemical U.S.A.; CIBA-GEIGY Corp., Agricultural Division; General Foods Corp.; ICI Americas Inc., Agricultural Chemicals Division; Lilly Research Laboratories; Mobay Chemical Corp., Agricultural Chemicals Division; Rhone-Poulenc, Inc., Agrochemical Division; Rohm and Haas Co.; and Shell Companies Foundation. First Printing, May 1987 Second Printing, July 1987 Third Printing, October 1987 Fours Printing, Junel990 Library of Congress Catalog Card Number 87-61095 ISBN 0-309-03746-8 Copyright ~ 1987 by the National Academy of Sciences No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use without written permission from the publisher, except for the purposes of official use by the U.S. government. Printed in the United States of America

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Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation RAY THORNTON, Chairman, University of Arkansas DARRYL BANKS, New York State Department of Environmental Conservation DONALD BISSING, FMC Corporation GERALD A. CARLSON, North Carolina State University FERGUS CLYDESDALE, University of Massachusetts T. ROY FUKUTO, University of California, Riverside GEORGE KENNEDY, North Carolina State University RICHARD A. MERRILL, University of Virginia WARREN R. MUIR, Hampshire Research Associates, Inc. GAIL M. PESYNA, E. I. du Pont de Nemours & Co., Inc. DEXTER SHARP, Monsanto Co. (retired) EARL SWANSON, University of Illinois MICHAEL R. TAYLOR, King & Spalding FRED H. TSCHIRLEY, Michigan State University (retired) ARTHUR C. UPTON, New York University EILEEN VAN RAVENSWAAY, Michigan State University PAUL WAGGONER, Connecticut Agricultural Experiment Station Staff RICHARD WILES, Project Officer *CONNIE MUSGROVE, Project Officer JOHN WARGO, Consultant DELORES CARTER, Senior Secretary ROMA DECOTEAU, Senior Secretary *Through January 1987 . . .

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Board on Agriculture WILLIAM L. BROWN, Chairman, Pioneer Hi-Bred International, Inc. JOHN A. PING, Vice-Chairman, National Research Council PERRY L. ADKISSON, Texas A&M University C. EUGENE ALLEN, University of Minnesota tEDWIN H. CLARK II, The Conservation Foundation TELLIS B. COWLING, North Carolina State University JOSEPH P. FONTENOT, Virginia Polytechnic Institute and State University ROBERT M. GOODMAN, Calgene, Inc. RALPH W. F. HARDY, Boyce Thompson Institute and BioTechnica International, Inc. *ROGER L. MITCHELL, University of Missouri CHARLES C. MUSCOPLAT, Molecular Genetics, Inc. tKARL H. NORRIS, U.S. Department of Agriculture, Beltsville, Maryland *ELDOR A. PAUL, Michigan State University VERNON W. RUTTAN, University of Minnesota tCHAMP B. TANNER, University of Wisconsin *JAMES A. TEER, Welder Wildlife Foundation THOMAS D. TRAUTMAN, General Mills, Inc. JAN VAN SCHILFGAARDE, U.S. Department of Agriculture, Fort Collins, Colorado VIRGINIA WALBOT, Stanford University CONRAD J. WEISER, Oregon State University CHARLES M. BENBROOK, Executive Director JAMES E. TAVARES, Associate Executive Director CARLA CARLSON, Reports Officer and Senior Editor GRACE JONES ROBBINS, Assistant Editor *Term ended December 31, 1986 tTerm began January 1, 1987 1V

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Preface In February 1985, the U.S. Environmental Protection Agency (EPA) asked the Board on Agriculture of the National Research Council to study the EPA's methods for setting tolerances for pesticide residues in food. Specifically, the EPA asked the board to examine the current and likely future impacts of the Delaney Clause on the tolerance-setting process. The Delaney Clause is a provision of the Federal Food, Drug and Cosmetic (FDC) Act, which is the law that governs the setting of pesticide tolerances. The clause purports to bar the EPA from granting any tolerance for a pesticide residue that has been found to induce cancer in animals and that concentrates in processed food. The board was asked to consider the impact of this prohibition on the availability of agricultural pesticides and the protection of the public health. To conduct the study, the board formed the Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricul- tural Innovation. The committee includes experts in agricultural pest control, pesticide development, agricultural economics, cancer risk as- sessment, public health, food science, regulatory decision making, and law. The committee undertook three principal tasks in preparing this report. First, it examined the statutory framework for setting tolerances for pesticide residues in food and the operation of the tolerance-setting process at the EPA. Second, it developed a computerized data base for estimating the impacts of the current standards for setting tolerances on dietary cancer risk as well as on pesticide use and development. Third, it v

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vi PREFACE analyzed the impacts of different standards for establishing pesticide tolerances on dietary cancer risk and pesticide use and development. The report is organized into six chapters preceded by an Executive Summary that contains the committee's findings, conclusions, and rec- ommendations. Chapter 1 introduces the problem. Chapter 2 describes the current law and administrative system for setting pesticide tolerances, with special attention to the sometimes divergent mandates of the FDC Act and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Chapter 3 presents a profile of potential cancer risk from tolerances currently associated with pesticide residues in food. It helps to illuminate the scope of the problem confronting the EPA. Chapters 4 and 5 describe four alternative scenarios for establishing or adjusting tolerances for oncogenic pesticide residues and compare the change in potential cancer risks and pesticide use patterns likely to be achieved under each scenario. Chapter 6 shows the prospects for developing new chemical pesticides and other innovative approaches to pest control and summarizes potential implications of the current regulatory framework for these innovations. The committee is impressed by the challenges facing the EPA in its efforts to regulate pesticide residues in food. The law is textually complex and difficult to implement. Relevant scientific knowledge is expanding rapidly, presenting new issues and problems daily. Public demands and expectations are unrelenting. The committee hopes this report will assist the EPA's effort in this important area of regulation. RAY THORNTON Chairman

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Acknowledgments The complexity of this report posed unusual challenges to the commit- tee. Many people deserve special thanks for their contributions to this task. The committee's analysis and this report would not have been possible without support and cooperation from Environmental Protection Agency officials and scientists: Douglas Campt, Reto Engler, John A. Moore, Steven Schatzow, and Richard Schmidt. These and other indi- viduals facilitated the committee's use of the agency's Tolerance Assess- ment System and provided other essential data and guidance needed to understand current EPA policy and practice. The committee expresses its appreciation to John P. Wargo, Yale University, for designing the data base and responding to requests for additional analyses. It also thanks Bruce S. Wilson, U.S. Court of Appeals for the Eighth Circuit, for providing the legal history of the Delaney Clause. The committee is grateful for the diligence and creativity of the Board on Agriculture staff, particularly that of project officers Connie Musgrove and Richard Wiles. The substantive contribution of Richard Wiles is especially noteworthy. The committee also appreciates the dedication of Delores Carter and Roma DeCoteau as they worked on the manuscript through many drafts. And it thanks the editors, Carla Carlson and Grace Jones Robbins. V11 . .

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Contents EXECUTIVE SUMMARY INTRODUCTION........................ FIFRA and the FDC Act, 18 The Delaney Clause and the Purpose of This Report, 20 The Committee's Tasks, 21 2 THE CURRENT SYSTEM: THEORY AND PRACTICE Registration of Pesticides Under FIFRA, 23 Tolerance Setting Under the FDC Act, 24 The Data Call-In Program, 36 The Delaney Clause A Closer Examination, 37 Summary of Problems and Issues Posed by the Delaney Clause, 40 ESTIMATES OF DIETARY ONCOGENIC RISKS . Introduction, 45 Description of the Data Base and the Analytical Method, 50 Estimation of Oncogenic Risk, 63 EPA's Interpretation of the Delaney Clause to Date, 83 Case Studies of Potential Policy Precedents, 91 Projecting Past Actions into the Future, 96 The Short-Term Potential Impact of the Delaney Clause, 97 1X . 17 .. 23 . 45

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x CONTENTS 4 THE SCENARIOS AND THE RESULTS. Introduction, 100 Analytical Methods, 102 Description of the Scenarios and Results, 103 COMPARING THE IMPACT OF THE SCENARIOS. The Impacts of the Scenarios on Herbicides, Insecticides, and Fungicides, 118 The Impacts of the Scenarios on Individual Active Ingredient Risk, 120 A Crop-Level Analysis: The Impacts of the Scenarios on Benefits and Risks, 123 Alternatives to the Scenarios, 129 6 PESTICIDE INNOVATION AND THE ECONOMIC EFFECTS OF IMPLEMENTING THE DELANEY CLAUSE ....................... The Innovation Process and the Pesticide Industry, 137 Review of Industry R&D and Studies to Date, 139 Future Prospects in Chemical Pest Control, 145 Chemical Pesticide Prospects Relative to Dietary Risks, 148 Innovation Prospects in Pest Control, 150 Special Challenges to Innovation, 155 APPENDIXES A. Legislative History of the Pesticide Residues Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of 1958 Bruce S. Wilson ............. B. Analytical Methodology for Estimating Oncogenic Risks of Human Exposure to Agricultural Chemicals in Food Crops John P. Wargo ........................... C. Case Studies of the EPA's Application of the Delaney Clause in the Tolerance-Setting Process Richard Wiles ......... Fosetyl Al, 196 Benomyl, 198 Captan, 201 Chlorobenzilate, 204 Dicamba, 206 EBDCs, 208 Metalaxyl, 214 Permethrin, 217 Thiodicarb, 220 . 100 .118 . 136 . 161 . 174 . 196

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CONTENTS X1 D. Pesticide Innovation ............... Trends in Innovation Earl R. Swanson Weed Control Fred H. Tschirley.... Insect Control T. Roy FuLuto...... E. Survey of Pesticide R&D Directors: How Do Current Laws Affect Agricultural Pesticide Research Productivity? INDEX . . . 226 228 234 ~ . . 226 . 249 . 257

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Tables and Figures TABLES 1-1 Section 408 and 409 Food Tolerances Listed in the CFR, 19 2-1 Food Tolerances in the CFR, 35 2-2 Food Tolerances in the CFR for 53 Oncogens, 36 3-1 Agricultural Use Information for Selected Oncogenic Herbicides, 47 3-2 Fungicide Use for 10 Major U.S. Food Commodities, 48 3-3 Potentially Oncogenic Pesticides Identified by the EPA, 52 3-4 Number of Pesticides Identified as Oncogens by the EPA, 56 3-5 Comparative Consumption of Selected Crop Groups, 58 3-6 Comparative Consumption of Selected Raw and Processed Crops, 58 3-7 Presumed Oncogenic Pesticides with Section 409 Tolerances, 63 3-8 Processed Foods in the Tolerance Assessment System (TAS) Compared with Section 409 Tolerances, 64 3-9 Estimated Oncogenic Risk from Dietary Exposure to 28 Pesticides, 68 3-10 Estimated Oncogenic Risk Distribution by Pesticide Type on Fresh and Processed Foods, 69 3-11 Crop Requirements for Processing Studies Under Current EPA Guidelines, 70 3-12 Worst-Case Impact of the Delaney Clause, 71 3-13 Industry Recommendations of Processed By-products Requiring Tolerances, 72 Animal Feeds Not Subject to Feed-Additive Regulations, 73 Estimated Oncogenic Risk from Meat, Milk, Dairy, and Poultry Products, 74 3-16 Distribution of Estimated Oncogenic Risk by Pesticide Type, 74 . . Xll

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TABLES AND FIGURES Xiii Estimated Oncogenic Risk from Dietary Exposure to Selected Herbicides, 76 3-18 Estimated Oncogenic Risk from Dietary Exposure to Selected Insecticides, 77 3-19 Estimated Oncogenic Risk from Dietary Exposure to Selected Fungicides, 77 3-20 Fifteen Foods with the Greatest Estimated Oncogenic Risk, 78 3-21 Estimated Oncogenic Risk from Herbicides in Major Foods, 79 3-22 Estimated Oncogenic Risk from Insecticides in Major Foods, 80 3-23 Estimated Oncogenic Risk from Fungicides in Major Foods, 80 3-24 Estimated Oncogenic Risk from All Active Ingredients Used on Selected Foods, 83 3-25 Foods with the Greatest Estimated Oncogenic Risk from Herbicides, 84 3-26 Foods with the Greatest Estimated Oncogenic Risk from Insecticides, 84 3-27 Foods with the Greatest Estimated Oncogenic Risk from Fungicides, 85 3-28 Estimated Oncogenic Risk from Tolerances over Time, 86 3-29 Tolerance Actions for Which the Delaney Clause Was Cited, 88 3-30 Pesticide Active Ingredients Under Review for Which the Delaney Clause Has Been a Concern, 89 3-31 Pesticides with Retracted or Unpursued Tolerance Applications, 90 3-32 Number of Cancer Studies Due for Pesticide Active Ingredients, 1986-1990, 96 3-33 Potential Short-Term Impact of the Delaney Clause on Selected Fungicides, 97 3-34 Potential Short-Term Impact of the Delaney Clause on Selected Herbicides, 98 4-1 Key Features of the Four Scenarios Examined by the Committee, 104 4-2 Scenario 1 Reduction in Estimated Risk, 105 4-3 Scenario 1 Effect on Active Ingredients, Tolerances, and Crops, 106 4-4 Impacts of Scenario 1 on Major Crop Uses for Registered Pesticides, 107 4-5 Scenario 2 Reduction in Estimated Risk, 108 4-6 Scenario 2 Effect on Active Ingredients, Tolerances, and Crops, 109 4-7 Impacts of Scenario 2 on Major Crop Uses for Registered Pesticides, 111 4-8 Scenario 3 Reduction in Estimated Risk, 112 4-9 Scenario 3- Effect on Active Ingredients, Tolerances, and Crops, 113 4-10 Impacts of Scenario 3 on Major Crop Uses for Registered Pesticides, 114 4-11 Scenario 4 Reduction in Estimated Risk, 115 4-12 Scenario 4 Effect on Active Ingredients, Tolerances, and Crops, 116 4-13 Impacts of Scenario 4 on Major Crop Uses for Registered Pesticides, 116 5-1 Estimated Risk Reduction for Each Type of Pesticide by Scenario, 119 5-2 Impact of Scenarios on Different Pesticide Active Ingredients, 121 5-3 Risk, Acre Treatment, and Expenditure Reductions for Selected Crop-Pesticide Combinations, 122 5-4 Potential Short-Term Impact of the Delaney Clause on Selected Fungicides, 132

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XIV TABLES AND FIGURES Estimated Change in Dietary Oncogenic Risk in Some Crops from Revoking Benomyl Tolerances, 133 Estimated Change in Dietary Oncogenic Risk in Some Crops from Revoking EBDC Tolerances, 134 6-1 Pesticide Industry Total R&D Expenditures, 141 6-2 Number of Chemicals Registered for the First Time as Pesticides Under FIFRA (1967-1984), 143 6-3 Evaluation of Experimental and Unregistered Citrus Insecticides, 146 6-4 Number of Herbicides in Field Tests, 147 6-5 Evaluation of Experimental and Unregistered Fungicides, 148 6-6 Current Status of Pesticides and Available Alternatives, 149 FIGURES 3-1 Percentage of theoretical maximum residue contribution for oncogenic pesticides by pesticide type, 60 Percentage of estimated dietary oncogenic risk from fungicides, herbicides, and insecticides, 75 Concentration of total estimated dietary oncogenic risk in selected foods, 78 3-4 Risk from tolerances granted before and after 1978, 87 6-1 Pesticide development from production to commercialization, 138 6-2 Estimated dietary oncogenic risk and R&D expenditures by pesticide type, 150

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REGULATING PESTICIDES IN FOOD

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