0910-AC45 200310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" The Food and Drug Administration (FDA) amended its regulations relating to the operational definition of the term "no residue." The definition is used in determining whether any residue of carcinogenic compounds used in food-producing animals would "be found in the food produced from those animals under conditions of use reasonably certain to be followed in practice" (21 CFR 500.80(a)). Under the previous operational definition of no residue, it was possible for a residue detected by a method approved by FDA to be considered "no residue." FDA revised its regulations to make them consistent with a 1995 Department of Justice opinion regarding this definition. The changes revised the definition of "no residue" to mean that no residue is detected with an approved regulatory method. The rule has several conditions that sponsors of carcinogenic compounds must satisfy with respect to the sponsors' proposed regulatory methods. Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 500.80 21 CFR 500.82 21 CFR 500.84 21 CFR 500.88 21 USC 321 21 USC 331 21 USC 342 21 USC 343 21 USC 348 21 USC 351 to 353 21 USC 360b 21 USC 371 No NPRM 01/17/2002 67 FR 2384 NPRM Comment Period Ends 04/17/2002 Final Action 12/23/2002 67 FR 78172 No None NA Not Collected 0910-AC13 Previously reported as Steven Brynes 0910 Food and Drug Administration FDA 301 827-6975 sbrynes@cvm.fda.gov HFV-151, Center for Veterinary Medicine, 7500 Standish Place, Rockville MD 20855