Abstract

Joseph V. Rodricks recently resigned his position as Associate Commissioner for Science at the FDA. His career at FDA spanned 15 years in which he was involved in developing guidelines for the conduct and evaluation of toxicity studies used for the safety evaluation of food additives and contaminants. He is currently Science Director at Clement Associates, a Washington consulting firm specializing in toxic substance hazard evaluation. In the United States, concerns about the safety of food have been embodied in laws that dictate the conditions under which new substances may be deliberately added to foods to achieve des~ired technological goals. These laws recognize that society benefits from the use of additives in food production, but they also place certain demands on manufacturers who wish to introduce such substances into commerce. Specifically, manufacturers are required to provide information about the chemical and toxicological properties of a proposed food additive sufficient to show the safety of the substance under its proposed conditions of use. If a showing of safety (which the law defines as 'reasonable certainty of no harm') cannot be made, then a proposed additive cannot legally be used in food. DES, while not directly added to food, can enter food indirectly because of its use as an animal growth promotant, and it is therefore subject to the food additive requirements of law. In its recent action to prohibit the use of DES as an animal growth promotant, the U.S. Food and Drug Administration (FDA) held that the manufacturers of DES had failed to provide the information necessary to ascertain that animal drug uses of DES are safe. Professor Jukes has thus misinterpreted the basis of FDA's action, the full details of which are set forth in the official document he cites 1.

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