title: Research activities in toxicology and toxicological requirements of the FDA for food and color additives.
abstract: The Center for Food Safety and Applied Nutrition of the Food and Drug Administration has published guidelines for the safety assessment of direct food and color additives. These guidelines are to be updated beginning in 1988. The safety of a food and color additive must be established prior to marketing by an evaluation of probable exposure of consumers and appropriate toxicological information. "Safe" and "safety" are defined as a reasonable certainty that a substance is not harmful under the intended conditions of use. A number of tests are used in determining the safety of food additives. Some of these are: subchronic toxicity studies, chronic toxicity studies, carcinogenicity, reproduction, teratogenicity, and occasionally short-term tests for carcinogenicity. The Center also has a research program in toxicology which in part focuses on diet/toxicity interaction and risk assessment. Examples of such activities are investigation of the teratogenicity of textured vegetable protein and of the potential of zinc to prevent or ameliorate such effects, the development of whole rat embryo cultures as a model to investigate the mechanisms by which teratogens may act, and a program in pharmacokinetics and molecular toxicology to aid in studying assumptions underlying risk assessment.
authors.affiliation: Division of Toxicology, Food and Drug Administration, Washington, D.C. 20204.
authors.forename: S
authors.initials: S
authors.lastname: Green
mesh_terms: D005503:Food Additives / Q000592:standards / Q000633:toxicity*; D012106:Research; D014116:Toxicology / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005503:Food Additives