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.