ROCKVILLE, MdThe FDA has amended its regulations for testing the carcinogenicity of compounds used in food-producing animals to eliminate the specific requirement for oral, chronic, dose-response studies. The new wording states that bioassays must be designed to assess carcinogenicity and to determine the quantitative aspects of any carcinogenic response.
When the existing regulation was issued, chronic studies were the standard. However, advances in carcinogenicity modeling have changed scientists views. For example, many researchers now agree that a chronic study may not measure the appropriate time point necessary to assess carcinogenicity for some compounds, the FDA said.