Zdrowie i gospodarka · 20/06/1996

Carcinogenicity Testing of Compounds Used in Food-Producing Animals

The Food and Drug Administration (FDA) is proposing to revise the regulation that sets forth the requirements for the carcinogenicity testing of compounds used in food-producing animals to allow the agency and sponsors greater flexibility when choosing the types of studies used for testing the carcinogenicity of compounds used in food- producing animals. FDA is proposing to revise the study requirements because FDA recognizes that advances in models used to assess the carcinogenicity of compounds have been made. The specific requirement that a sponsor must conduct oral, chronic, dose-response studies would be deleted under the proposed regulation. Sponsors would have more options for testing the carcinogenicity of compounds used in food- producing animals. This proposal implements the goals stated by the National Performance Review.