FDA amends carcinogenicity testing requirements
Updated regulations eliminate requirement that a sponsor conduct oral, chronic, dose-type studies.
The Food and Drug Administration (FDA) is amending the regulations governing carcinogenicity testing requirements for food-producing animals.
The updated regulations eliminate the specific requirement that a sponsor has to conduct oral, chronic, dose-type studies. When the existing regulation was issued, chronic studies were the standard test for carcinogenicity. But research has shown that a chronic study may not be the best method for carcinogenicity testing, so the updated regulation allows for other study designs.
The regulation is designed to prevent using in food-producing animals compounds that may cause cancer in humans. However, compounds may be used if it can be determined that no residue from them will remain in the food produced from those animals.
The rest of the regulation remains unchanged. The full regulation can be found in 21 CFR 500.80.