Concern about health effects from exposure to pesticides in foods is growing as scientists learn more about the toxic properties of pesticides. The Delaney Clause, a provision of the Food, Drug and Cosmetic Act, prohibits tolerances for any pesticide that causes cancer in test animals or in humans if the pesticide concentrates in processed food or feeds. This volume examines the impacts of the Delaney Clause on agricultural innovation and on the public's dietary exposure to potentially carcinogenic pesticide residues. Four regulatory scenarios are described to illustrate the effects of varying approaches to managing oncogenic pesticide residues in food.

Contents

• Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation
• Board on Agriculture
• Preface
• Acknowledgments
• Executive Summary
• 1. Introduction
  • FIFRA and the FDC Act
  • The Delaney Clause and the Purpose of This Report
  • The Committee's Tasks
• 2. The Current System: Theory and Practice
  • Registration of Pesticides Under FIFRA
  • Tolerance Setting Under the FDC Act
  • The Data Call-In Program
  • The Delaney Clause—A Closer Examination
  • Summary of Problems and Issues Posed By the Delaney Clause
• 3. Estimates of Dietary Oncogenic Risks
  • Introduction
  • Description of the Data Base and the Analytical Method
  • Estimation of Oncogenic Risk
  • Epa's Interpretation of the Delaney Clause to Date
  • Case Studies of Potential Policy Precedents
  • Projecting Past Actions Into Tile Future
  • The Short-Term Potential Impact of the Delaney Clause
• 4. The Scenarios and the Results
  • Introduction
  • Analytical Methods
  • Description of the Scenarios and Results
• 5. Comparing the Impact of the Scenarios
  • The Impacts of the Scenarios on Herbicides, Insecticides, and Fungicides
  • The Impacts of the Scenarios on Individual Active Ingredient Risk
  • A Crop-Level Analysis: the Impacts of the Scenarios on Benefits and Risks
  • Alternatives to the Scenarios
• 6. Pesticide Innovation and the Economic Effects of Implementing the Delaney Clause
  • The Innovation Process and the Pesticide Industry
  • Review of Industry R&D and Studies to Date
  • Future Prospects in Chemical Pest Control
  • Chemical Pesticide Prospects Relative to Dietary Risks
  • Innovation Prospects in Pest Control
  • Special Challenges to Innovation
• Appendixes
  • A Legislative History of the Pesticide Residues Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of 1958
  • B Analytical Methodology for Estimating Oncogenic Risks of Human Exposure to Agricultural Chemicals In Food Crops
  • C Case Studies of the EPA's Application of the Delaney Clause in the Tolerance-Setting Process
  • D Pesticide Innovation
  • E Survey of Pesticide R&D Directors: How Do Current Laws Affect Agricultural Pesticide Research Productivity?

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.

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.