FDA'S Policy for Foods Developed by Biotechnology
(The following document is a chapter in the proceedings of American Chemical Society Symposium Series No. 605, 1995. It was presented by J. H. Maryanski, Strategic Manager for Biotechnology, Center for Food Safety and Applied Nutrition, FDA.)


Table of Contents
Abstract
Introduction
FDA's Role in Assuring Food Safety
Chymosin: The First Biotechnology-Derived Food Ingredient
FDA's Policy for Foods Derived from New Plant Varieties
Evaluation of the Flavr Savr Tomato
Labeling
Summary
Postscript
Acknowledgments
Literature Cited

Abstract
The Food and Drug Administration (FDA) has authority under the Federal Food, Drug, and Cosmetic Act (the Act) to ensure the safety and wholesomeness of most foods, except meat and poultry, including foods developed through modern biotechnology. In 1990, FDA issued the first regulation for the use of a recombinant DNA-produced food ingredient, fermentation-derived chymosin (rennet). In 1992, FDA published a policy statement that explains how foods and animal feeds derived from new plant varieties developed by both conventional and new breeding techniques are regulated under the Act. The 1992 policy provides "guidance to industry" that established a standard of care for assuring safety and wholesomeness. This discussion will summarize FDA's policy and illustrate how the policy was applied by the agency in reaching decisions on chymosin and on the Flavr Savr tomato.

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