Updating Developmental Toxicity Testing Guidelines for the Safety Assessment of Direct Food Additives and Color Additives Used in Food: Results of a Survey

Abstract

In 1982, the Food and Drug Administration (FDA) issued guidelines for testing the effects of direct food additives and color additives on developing embryos and for longer monitoring during several generations. In 1984, an FDA task force began a review of testing procedures for reproductive and developmental toxicity. The Developmental Toxicity Committee was formed specifically to evaluate the current guidelines and to propose revisions. As part of the evaluation, a two-part questionnaire was devised and sent to about 800 members of the Teratology Society and the Reproductive and Developmental Toxicity Specialty Section of the Society of Toxicology. The questionnaire included questions on multigeneration reproduction and developmental toxicity. A total of 132 responses (16.5%) were received, and they are discussed in detail in this report. The responses to the multigeneration reproduction questions were concerned with the optimum number of generations and litters, reduction of litter size for standardization, selection of offspring to produce the next generation, parameters to be measured, indices to be calculated, length of premating exposure, additional protocols, and microscopic examination of the offspring. Responses to the developmental toxicity questions were concerned with dose levels, diet variations, route of administration, examination of the offspring, and control of bias.