Regulating pesticides in food : the Delaney paradox / Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation, Board on Agriculture, National Research Council.

Format:

Book

Author/Creator:

National Research Council (U.S.). Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation.

Contributor:

National Research Council (U.S.). Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation.

Language:

English

Subjects (All):

Pesticides--Government policy--United States.

Pesticides.

Pesticides--Toxicology.

Pesticide residues in food.

Physical Description:

1 online resource (288 pages)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1987.

Language Note:

English

Summary:

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:

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

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&amp

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

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

4 The Scenarios and the Results

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

Effects on Individual Active Ingredients

Crop-Level Impacts

Scenario 3

Impacts on Individual Active Ingredients

Scenario 4

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

EBDCs

6 Pesticide Innovation and the Economic Effects of Implementing the Delaney Clause

THE INNOVATION PROCESS AND THE PESTICIDE INDUSTRY

REVIEW OF INDUSTRY R&amp

D AND STUDIES TO DATE

Survey of R&amp

D Directors

Historical Perspective of R&amp

Insecticides

Herbicides

Fungicides

FUTURE PROSPECTS IN CHEMICAL PEST CONTROL

Citrus and Cotton Insecticides

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

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

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

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

Pest Resistance

Alternatives

Captan

Summary, of Oncogenic Findings

Estimate of Dietary Oncogenic Risk

Other Chronic Health Risks

Chlorobenzilate

Benefits and Alternatives

Oncogenic Contaminants and the Delaney Clause

Discussion.

General Safety Clause

The Constituents Policy

Benefits of Dicamba

Ethylenebisdithiocarbamates (EBDCs)

ETU

Summary of Oncogenic Findings

Dietary Exposure

Risk Assessment

History

Conversion to ETU

Metalaxyl

Estimation of Risk

Potential Uses and Alternatives

Delaney Clause Issues

Tomatoes

Corn

Soybeans

Discussion

Thiodicarb and Methomyl

Sensitivity-of-the-Method Procedure

D Pesticide Innovation

Trends in Innovation

Weed Control

New Chemistry

Allelopathy

Conclusions

Insect Control

Introduction

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

E Survey of Pesticide R&amp

D Directors: How Do Current Laws Affect Agricultural Pesticide Research Productivity?

Index.

Notes:

Bibliographic Level Mode of Issuance: Monograph

ISBN:

1-280-22158-5

9786610221585

0-309-55507-8

0-585-15000-1

OCLC:

43477179