Food and Drug Administration: approach to evaluating neurotoxicity.

One of the primary features of the mission of the Food and Drug Administration is to assure with reasonable certainty that no harm will result from the intended use of chemicals added to food. In carrying out this mission the FDA uses a structured process to assess the safety of each food chemical. The detailed mechanics of this process are described in an FDA document entitled "Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Use in Food" (Food and Drug Administration, 1982). Central to its evaluation the FDA requires a collective set of information, including estimates of the anticipated human exposure to the food chemical and a broad-based toxicological profile. Certainly, any adverse effect observed in the nervous system is recognized as an important element in the determination of chemical safety and follow-up information which would enable an assessment of such an effect to be included in the toxicological profile. The agency's current approach to evaluating neurotoxicity should be viewed within the context of its overall strategy for the safety assessment of food chemicals. Four basic premises underlie the FDA's approach to safety assessment.