FDA to Revise Tolerances for Residues of New Animal Drugs in Food

The Food and Drug Administration (FDA) has issued a proposed rule that
would update tolerances “for residues of approved and conditionally
approved new animal drugs in food by standardizing, simplifying, and
clarifying the determination standards and codification style.” According to
FDA, the regulations describing how to set animal drug tolerances for human
food are not uniform, do not provide all relevant information, and “no longer
accurately reflect current regulatory science.”

“For example, the regulations provide the ADI [acceptable daily intake] and safe concentrations for some, but not all, drugs,” states the proposed rule. “In addition, the regulations list some tolerances as being for ‘negligible’ residue, and others as ‘no residue,’ ‘zero’ or ‘not required,’ but they do not explain what these important terms mean. The proposed rule addresses these inconsistencies by simplifying and standardizing the determination standards and codification style and by adding definitions for key terms.” FDA will accept comments on the proposal until March 5, 2013. See Federal Register, December 5, 2012.