August 22, 2012
The Food and Drug Administration (FDA) today is announcing the publication of a final rule that implements certain technical amendments to the regulations on carcinogenic compounds used in food-producing animals (subpart E of part 500, title 21 of the Code of Federal Regulations). These amendments are intended to clarify certain provisions of the regulation, but do not alter the existing process for approving carcinogenic compounds.
In particular, this final rule revises the definitions of the terms “So” and “Sm”, terms used to express the concentrations of residues of carcinogenic concern in the total human diet and in specific edible animal tissues, respectively. The revisions are intended to emphasize that these terms primarily refer to the concentration of a residue of carcinogenic concern that represents no significant increase in the risk of cancer to the human consumer, rather than on the specific 1 in 1 million risk of cancer to the test animals approach.
FDA sought comment on these changes through a proposed rule published on December 20, 2010 (75 FR 79320). The Agency received few comments and the proposed revisions were finalized without change.
Under Section 512(d)(1)(I) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), known as the Delaney Clause, FDA cannot approve any compound for use in food-producing animals where the drug or its metabolites has been found to induce cancer in man or animals.
There is an exception, however, commonly referred to as the DES (Diethylstilbestrol) Proviso. The DES proviso carves out an exception to the Delaney Clause allowing cancer-causing compounds (or compounds with cancer-causing metabolites) to be used in food-producing animals if: 1) the drug does not harm the animal, and 2) tests approved by FDA do not detect residues of the drug in any food from the animal. The regulations under part 500 implement the DES Proviso.