[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.80]

[Page 12]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
 Subpart E--Regulation of Carcinogenic Compounds Used in Food-Producing 
                                 Animals
 
Sec. 500.80  Scope of this subpart.

    Source: 52 FR 49586, Dec. 31, 1987, unless otherwise noted.


    (a) The Federal Food, Drug, and Cosmetic Act requires that sponsored 
compounds intended for use in food-producing animals be shown to be safe 
and that food produced from animals exposed to these compounds be shown 
to be safe for consumption by people. The statute prohibits the use in 
food-producing animals of any compound found to induce cancer when 
ingested by people or animals unless it can be determined by methods of 
examination prescribed or approved by the Secretary (a function 
delegated to the Commissioner of Food and Drugs under Sec. 5.10 of this 
chapter) that no residue of that compound will be found in the food 
produced from those animals under conditions of use reasonably certain 
to be followed in practice. This subpart provides an operational 
definition of no residue and identifies the steps a sponsor of a 
compound shall follow to secure the approval of the compound. FDA 
guidance documents contain the procedures and protocols FDA recommends 
for the implementation of this subpart. These guidance documents are 
available from the Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 
Requests for these guidance documents should be identified with Docket 
No. 83D-0288.
    (b) If FDA concludes on the basis of the threshold assessment that a 
sponsor shall conduct carcinogenicity testing on the sponsored compound, 
FDA will also determine whether and to what extent the sponsor shall 
conduct carcinogenicity testing on metabolites of the sponsored 
compound. The bioassays that a sponsor conducts must be designed to 
assess carcinogenicity and to determine the quantitative aspects of any 
carcinogenic response.
    (c) If FDA concludes on the basis of the threshold assessment or at 
a later time during the approval process that the data show that the 
sponsored compound and its metabolites should not be subject to this 
subpart, FDA will continue to consider the compound for approval under 
the general safety provisions of the act for risks other than cancer.
    (d) This subpart does not apply to essential nutrients.

[52 FR 49586, Dec. 31, 1987, as amended at 59 FR 14365, Mar. 28, 1994; 
62 FR 66983, Dec. 23, 1997; 65 FR 56480, Sept. 19, 2000]