Regulating Pesticides in Food -- Copyright -- Preface -- Acknowledgments -- Contents -- REGULATING PESTICIDES IN FOOD -- Executive Summary -- THE COMMITTEE'S ESTIMATES OF ONCOGENIC RISK -- ESTIMATED ONCOGENIC RISK AND ITS DISTRIBUTION IN THE FOOD SUPPLY -- Findings -- IMPACTS OF FOUR ALTERNATIVE WAYS TO REGULATE ONCOGENIC RESIDUES -- Results of the Scenarios -- Findings -- AN ANALYSIS OF THE FUNGICIDES: A SPECIAL CASE -- PESTICIDE INNOVATION AND ALTERNATIVE PEST-CONTROL METHODS -- Alternative Technologies -- The Effect of the Delaney Clause on R&D -- The Minor Use Issue -- The Delaney Clause and Pest Resistance -- MAJOR CONCLUSIONS AND RECOMMENDATIONS -- Legal Basis for Regulation -- A Nonzero Standard for Oncogenic Risk -- Targeting High-Risk Pesticide and Crop Uses -- The Adoption of an Analytical Framework -- 1 Introduction -- FIFRA AND THE FDC ACT -- THE DELANEY CLAUSE AND THE PURPOSE OF THIS REPORT -- THE COMMITTEE'S TASKS -- NOTES -- 2 The Current System: Theory and Practice -- REGISTRATION OF PESTICIDES UNDER FIFRA -- TOLERANCE SETTING UNDER THE FDC ACT -- Section 408-The Statutory Standard -- Section 409 -- The Tolerance-Setting Process Under Sections 408 and 409 -- Overview of the Process -- Specific Data Requirements -- Oncogenicity and Carcinogenicity -- Tolerance Setting for Non-Oncogenic Pesticides Under Section 408 -- Tolerance Setting for Oncogenic Compounds Under Section 408 -- Tolerance Setting Under Section 409 -- THE DATA CALL-IN PROGRAM -- THE DELANEY CLAUSE-A CLOSER EXAMINATION -- SUMMARY OF PROBLEMS AND ISSUES POSED BY THE DELANEY CLAUSE -- Inconsistency -- The Issue of Concentration in Processed Foods -- Paradoxical Regulatory Results -- NOTES -- 3 Estimates of Dietary Oncogenic Risks -- INTRODUCTION -- Pesticide Use Patterns in the United States -- Pesticide Use Data -- Problems in Estimating Current Risk.

DESCRIPTION OF THE DATA BASE AND THE ANALYTICAL METHOD -- The Universe of Oncogenic Pesticides -- Estimating Dietary Exposure to Pesticide Residues -- Food Consumption Data -- Method for Estimating Residues in Food -- Method for Estimating Exposure to Residues -- Method for Estimating Residues in Processed Foods -- ESTIMATION OF ONCOGENIC RISK -- An Analysis of Estimated Oncogenic Risk -- Distribution of Risk By Tolerance Type: Section 408 Versus Section 409 -- Oncogenic Risk Derived from Residues in Animal Feeds -- Distribution of Estimated Risk by Type of Pesticide -- Distribution of Estimated Risk by Active Ingredient -- Distribution of Estimated Risk by Crop -- EPA'S INTERPRETATION OF THE DELANEY CLAUSE TO DATE -- EPA Application of the Delaney Clause to New Active Ingredients -- CASE STUDIES OF POTENTIAL POLICY PRECEDENTS -- Tolerances for New Active Ingredients -- Prior-Sanctioned Pesticides -- Tolerance Actions and New Active Ingredients -- Fosetyl Al -- Permethrin -- Thiodicarb -- Dicamba -- Tolerance Actions and Old Active Ingredients -- Dicofol and Chlorobenzilate -- Benomyl -- PROJECTING PAST ACTIONS INTO TILE FUTURE -- THE SHORT-TERM POTENTIAL IMPACT OF THE DELANEY CLAUSE -- NOTES -- 4 The Scenarios and the Results -- INTRODUCTION -- Selection of Pesticide-Crop Combinations -- ANALYTICAL METHODS -- Dietary Risk -- Pesticide Use -- DESCRIPTION OF THE SCENARIOS AND RESULTS -- Scenario 1 -- Results -- Crop-Level Analysis -- Scenario 2 -- Results -- Effects on Individual Active Ingredients -- Crop-Level Impacts -- Scenario 3 -- Results -- Impacts on Individual Active Ingredients -- Crop-Level Impacts -- Scenario 4 -- Results -- Crop-Level Impacts -- Summary -- NOTE -- 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 -- Corn and Soybean Herbicides -- Cotton Insecticides -- Apple Fungicides -- Potato Fungicides -- Tomato Fungicides -- Peanut Fungicides -- ALTERNATIVES TO THE SCENARIOS -- Fungicides: a Special Case -- Cropwide Tolerance Reduction -- Benomyl -- EBDCs -- NOTES -- 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 -- Survey of R&D Directors -- Historical Perspective of R&D -- Insecticides -- Herbicides -- Fungicides -- FUTURE PROSPECTS IN CHEMICAL PEST CONTROL -- Citrus and Cotton Insecticides -- Corn and Soybean Herbicides -- Apple, Peanut, Potato, and Tomato Fungicides -- CHEMICAL PESTICIDE PROSPECTS RELATIVE TO DIETARY RISKS -- INNOVATION PROSPECTS IN PEST CONTROL -- Plant Breeding -- Genetic Engineering -- Biological Control -- Cultural Pest Control -- SPECIAL CHALLENGES TO INNOVATION -- The Minor-Use Issue -- Liability -- Interregional Project 4 -- The Pesticide Resistance Problem -- NOTES -- Appendixes -- A Legislative History of the Pesticide Residues Amendment of 1954 and the Delaney Clause of the Food Additives Amendment of… -- Statement of Problems -- Question Presented -- Conclusion -- Discussion of Authority -- The Delaney Committee Report -- The Pesticide Residues Amendments -- The Food Additives Amendment -- 1956 Hearings -- 1958 Hearings -- Addition of the Delaney Clause -- NOTES -- B Analytical Methodology for Estimating Oncogenic Risks of Human Exposure to Agricultural Chemicals In Food Crops -- Datamanagement System -- Data Base Construction -- Tape-to-Mainframe Transfer and Data Transformations -- Mainframe-to-Microcomputer Transfer -- Raw-to-dBASE III Format.

dBASE III-to-Lotus 1-2-3 Transfer -- Data Description and Sources -- Chemical Identification Data -- Chemical Tolerance Data -- Food Consumption Data -- Pesticide Residue Data -- Toxicological Data -- Regulatory Status Data -- Food Processing Data -- Chemical Use And Cost Data -- Pesticide-Commodity Codes -- Analytical Methods -- Risk Calculation -- Chemical Residues -- Consumption Estimates -- Estimate of Chemical Intake -- Potency Factor or Q -- Risk Estimates -- Percentage of Acres Treated -- Scenario Analyses -- Uncertainty in Oncogenic Risk Estimates -- Residue Estimates -- Food Consumption Estimates -- Acreage Treated -- Toxicological Certainty -- Conclusion-Worst-Case Scenario -- Notes -- C Case Studies of the EPA's Application of the Delaney Clause in the Tolerance-Setting Process -- Fosetyl AL -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary of Oncogenic Findings and Risk Estimation -- Tolerance and Delaney Clause Issues -- Benomyl -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary of Oncogenic Findings and Risk Estimation -- Tolerance and Delaney Clause Issues -- Pest Resistance -- Alternatives -- Captan -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary, of Oncogenic Findings -- Estimate of Dietary Oncogenic Risk -- Tolerance and Delaney Clause Issues -- Other Chronic Health Risks -- Chlorobenzilate -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary of Oncogenic Findings and Risk Estimation -- Tolerance and Delaney Clause Issues -- Benefits and Alternatives -- Dicamba -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Oncogenic Contaminants and the Delaney Clause -- Discussion -- General Safety Clause.

The Constituents Policy -- Benefits of Dicamba -- Ethylenebisdithiocarbamates (EBDCs) -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- EBDCs -- ETU -- Summary of Oncogenic Findings -- Dietary Exposure -- Risk Assessment -- Tolerance and Delaney Clause Issues -- History -- Conversion to ETU -- Alternatives -- Metalaxyl -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary of Oncogenic Findings -- Estimation of Risk -- Tolerance and Delaney Clause Issues -- Potential Uses and Alternatives -- Permethrin -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary of Oncogenic Findings and Risk Estimation -- Delaney Clause Issues -- Tomatoes -- Corn -- Soybeans -- Discussion -- Thiodicarb -- Description of the Chemical -- Regulatory Status -- Special Review Criteria Triggered -- Summary of Oncogenic Findings and Risk Estimation -- Thiodicarb and Methomyl -- Tolerance and Delaney Clause Issues -- Sensitivity-of-the-Method Procedure -- Notes -- D Pesticide Innovation -- Trends in Innovation -- Notes -- Weed Control -- Herbicides -- New Chemistry -- Biological Control -- Allelopathy -- Genetic Engineering -- Conclusions -- Notes -- Insect Control -- Introduction -- New Chemistry -- Octopamine Agonists -- Avermectins and Milbemycines -- Amidinohydrazones -- Benzoylphenylureas -- Pyrethroids -- Proinsecticides -- Natural Products -- Genetically Engineered Microorganisms -- Bacterial Insecticides -- Vital Insecticides -- Fungal Insecticides -- Future Developments in Microbiological Agents -- Summary -- Notes -- E Survey of Pesticide R&D Directors: How Do Current Laws Affect Agricultural Pesticide Research Productivity? -- Index.