A major difficulty with food irradiation from a regulatorypoint of view is that it is related to many food issues, such as safety, labeling and consumer acceptance. Food that i s intedionully irradiated is judged to be adulterated under current law unless there is a regulation for such use. As a first step in the rulemakingprocess, the Bureau of Foods has developed criteria useful for evaluating the safety of irradiated food by considering present knowledge in radiation chemistry and toxicity testing. These criteria will be used for evaluating existing toxicology studies and for developingpolicy on food irradiation.

Food irradiation has been a subject of controversy since its first use as a food process. This article reviews the legislative and regulatory history of food irradiation in the United States and the role of the U.S. Food and Drug Administration, then and now.This article also discusses the status of FDA's regulations on food irradiation in the production, processing, and handling of food, as promulgated in the April 18, 1986, final rule, and reviews the safety, labeling, and current good manufacturing practice.

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