Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary / Food Forum, Food and Nutrition Board, Institute of Medicine.

Format:

Book

Contributor:

Institute of Medicine (U.S.). Food Forum.

Language:

English

Subjects (All):

Food additives--United States--Congresses.

Food additives.

Food additives--Safety regulations--United States--Congresses.

Physical Description:

1 online resource (vii, 150 pages)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1999.

Language Note:

English

Summary:

The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.

Contents:

Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies

Copyright

PREFACE

Contents

WORKSHOP SUMMARY

INTRODUCTION AND BACKGROUND

OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES

Food Additives

GRAS SUBSTANCES

Interim Additives

LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS

Flaws of the Current Review Process

Proposed Changes in the Approval Process

Change or Enforce Deadlines for Petition Reviews

Implement User Fees

Grant a Period of Market Exclusivity

Re-evaluate GRAS Affirmation Process

Eliminate Notice-and-Comment Procedures

Abbreviate Review for Supplemental Uses

Evaluate Use of Extramural Petition Review

Prioritize Reviews

Implement Safeguards to Prevent Sham Petitioning

Establish a Sunset Period for Interim Additives

Foster Improved Communication between Industry and FDA

Improve Quality of Petitions Submitted to FDA

SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS

CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY

CURRENT EFFORTS

International Efforts

IMPROVING THE REGULATORY REVIEW PROCESS

Government Perspective

Industry Perspective

Consumer Perspective

SUMMARY

APPENDIX A Legal Aspects of the Food Additive Approval Process

HISTORY

The Food, Drug, and Cosmetic Act of 1938

The Food Additives Amendment of 1958

DEFINITION OF FOOD ADDITIVE

Components of Food

Indirect Additives

Dietary Supplements

Generally Recognized as Safe

APPROVAL PROCEDURES

Food Additive Petitions

GRAS Affirmation Petitions

Interim Food Additives

SAFETY STANDARDS

General Safety Standard

Carcinogenicity and the Delaney Clause

Special Restrictions: Labeling

CASE STUDIES

Artificial Sweeteners: Aspartame

Biotechnology: Calgene's Tomato

Novel Macroingredients: Olestra.

THE COMPOSITE PICTURE

Track Records Compared

A Catalogue of Proposed Solutions

Internal Management Initiatives

Statutory Hammers

Prioritizing Reviews

Imposing User Fees

Extramural Reviews

Combatting Sham Petitioning

CONCLUSION

APPENDIX: INTERNATIONAL COMPARISONS

Canada

The United Kingdom

The European Union

Japan

REFERENCES

APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,…

TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES

Introduction

Developments in Analytical Chemistry

Developments in Toxicology

The Emerging Understanding of Mechanisms

Changes in Risk and Safety Assessment

Changes in Agriculture

Environmental Concerns

Consumer Activity

Changes in Food Marketing and Consumption Trends

The Impact on FDA

Provisions That Continue to Work Well after Six Decades

Conclusion

CYCLAMATE

Overview

Chronology

Comments

Lessons Learned

IRRADIATED POULTRY

OLESTRA

FD&amp

C RED NO. 2 (AMARANTH)

Comment

C RED NO. 3 (ERYTHROSINE)

TCE AND DCM

D-LIMONENE

BENZYL ACETATE

ISO-AMYL ACETATE

FURFURAL

PULSED LIGHT

CHYMOSIN

Lessons Learned.

APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop

WORKSHOP AGENDA

APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies

PARTICIPANTS LIST

ACRONYMS.

Notes:

Based on a workshop convened by the Food Forum, May 6-7, 1997.

Includes bibliographical references.

ISBN:

9786610185948

9780309184137

0309184134

9781280185946

1280185945

9780309597043

0309597048

9780585057804

058505780X

OCLC:

44957865