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HHS/FDA RIN: 0910-AC45 Publication ID: Spring 2003 
Title: Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 500.80    21 CFR 500.82    21 CFR 500.84    21 CFR 500.88   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/17/2002  67 FR 2384   
NPRM Comment Period Ends  04/17/2002    
Final Action  12/23/2002  67 FR 78172   
Next Action Undetermined      
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Previously reported as 0910-AC13 
Agency Contact:
Steven Brynes
Regulatory Scientist
Department of Health and Human Services
Food and Drug Administration
HFV-151, Center for Veterinary Medicine, 7500 Standish Place,
Rockville, MD 20855
Phone:301 827-6975

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