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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
OCR for page R16
