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HHS/FDA RIN: 0910-AG28 Publication ID: Spring 2011 
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 feed additive, color additive, or veterinary regulations regarding compounds of carcinogenic concern used in food-producing animals. No food additive drug can be deemed safe if it is found to induce cancer in man or animals. An exception can be made for drugs and additives used in food prducing animals if it can be found that: (1) An animal feed additive, color additive, or veterinary drug will not adversely affect the animal, and (2) no residue of the animal feed additive, color additive, or veterinary drug will be found in any edible portion of that animal when residues are measured according to an approved regulatory method. The approach permits the determination of the quantity of residues of carcinogenic concern in edible tissues (e.g. meat) that may be consumed daily by the human consumer with no significant increase in the risk of cancer. This quantity is termed the So. The So quantity is expressed as the concentration of residue of carcinogenic concern in the total diet that can safely be consumed by humans over a lifetime. The total diet refers to the daily 1500g typically consumed, of which 500g is assumed to come from meat. The So is typically presented as mg per person per day, or mg per kg body weight per day. The So is currently defined by regulation primarily as the concentration of the carcinogenic compound that corresponds to a maximum lifetime risk to the 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. FDA is also proposing a redefinition of Sm to conform to the revised definition of So. The total quantity of residues of carcinogenic concern in edible tissues derived from the So is termed the Sm. The Sm quantity is expressed as the total concentration of residues of carcinogenic concern in food which, when eaten at a given consumption rate, would not exceed the So. Specifically, FDA is proposing that Sm would mean the concentration of a residue of carcinogenic concern in a specific edible tissue corresponding to no significant increase in the risk of cancer to the human consumer, thus aligning more closely with the primary definition of So. 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: Final Rule Stage 
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  03/00/2012    
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