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HHS/FDA RIN: 0910-AG28 Publication ID: 2012 
Title: Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals 
Abstract: The Food and Drug Administration (FDA) plans to publish a final rule to amend regulations regarding food additives, color additives, and animal drugs of carcinogenic concern used in food-producing animals. No food additive, color additive, or animal drug can be deemed safe if it is found to induce cancer in man or animals. An exception can be made for animal drugs and additives used in food producing animals if it can be found that: (1) An animal feed additive, color additive, or animal drug will not adversely affect the animal, and (2) no residue of the animal feed additive, color additive, or animal drug will be found in any edible portion of that animal when residues are measured according to an approved regulatory method. FDA regulations impose requirements for the sensitivity of the approved regulatory method for testing residues of carcinogenic compounds in edible animal tissues. The regulatory method must be sensitive enough to detect levels of carcinogenic compound that corresponds to the level of the compound that may be consumed daily by the human consumer with no significant increase in the risk of cancer. The sensitivity is calculated by determining the concentration of residue of carcinogenic concern in the total diet that can safely be consumed by humans over a lifetime. This concentration is termed the So. The So is currently defined by regulation primarily as the concentration of the carcinogenic compound that corresponds to a maximum lifetime risk to test animals of 1 in 1 million, and secondarily as corresponding to the concentration of residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to people. FDA believes that a careful reading of the December 31, 1987, final rule (52 FR 49586) suggests that an emphasis on no significant increase in the risk of cancer to the human consumer, rather than on the specific 1 in 1 million approach, reflects the original intent of the regulation. Specifically, FDA is proposing a revision to the definition of So for clarification purposes so that the term primarily means the concentration of residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to the human consumer and secondarily corresponds to the concentration of test compound in the total diet of test animals that corresponds to a maximum lifetime risk of cancer in the test animals of 1 in 1 million. These changes reflect advances in scientific technology. Other clarifying and conforming changes are also being proposed. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 500.82 and 500.84 
Legal Authority: 21 USC 348(c)(3)(A); 21 USC 360b(d)(1)(I); 21 USC 371(a); 21 USC 379e(b)(5)(B) 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/20/2010  75 FR 79320 
NPRM Comment Period End  03/07/2011   
Final Action  08/22/2012  77 FR 50591 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Kevin Greenlees
Senior Science Advisor
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine, Room 238B (MPN-1, HFV-100), 7520 Standish Place,
Rockville, MD 20855
Phone:240 276-8214
Fax:240 276-8118
Email: kevin.greenlees@fda.hhs.gov

 
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