Carcinogenicity Testing of Compounds Used in Food-Producing Animals

The Food and Drug Administration (FDA) is amending the regulations that set forth the requirements for the carcinogenicity testing of compounds used in food-producing animals. The amended regulations will eliminate the specific requirement that a sponsor must conduct oral, chronic, dose-response studies. This action is intended to allow FDA and sponsors greater flexibility in choosing the types of studies used for testing the carcinogenicity of compounds used in food- producing animals. The increased flexibility will make it easier and more economical for sponsors to complete required testing. These actions are part of FDA's continuing effort to achieve the objectives set forth in the President's ``National Performance Review'' initiative, which is intended to provide a comprehensive review of all rules in order to identify those that are obsolete and burdensome and to delete or revise them.