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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 |
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Timetable:
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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 Email: sbrynes@cvm.fda.gov |