§500.84. Conditions for approval of the sponsored compound. — Inbound Citations

(2) For those compounds that FDA determines have been shown to induce cancer when ingested by man or animals, §§ 500.82 through 500.90 apply.

(8) Any information required under §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in Food-Producing Animals), where applicable.

(b) Any notification establishing, amending, or revoking an import tolerance will be made publicly available. A summary of the basis for the decision will be publicly released in accordance with the provisions of part 20 of this chapter. If FDA determines that the new animal drug referred to in the request is a new animal drug that induces cancer when ingested by people or animals, and the requester complies with the requirements of §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in Food-Producing Animals), the regulatory method for ascertaining the marker residue in the target tissue will be made publicly available. All information and safety data submitted with the request, or previously submitted information incorporated in, and considered as part of, a request on the basis of specific reference to such information, shall be available for public disclosure, also in accordance with the provisions of part 20 of this chapter. Trade secrets and confidential commercial or financial information are exempted from release under § 20.61 of this chapter.

(b) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)).

Essential nutrients means compounds that are found in the tissues of untreated, healthy target animals and not produced in sufficient quantity to support the animal's growth, development, function, or reproduction, e.g., vitamins, essential minerals, essential amino acids, and essential fatty acids. These compounds must be supplied from external sources.

FDA means the Food and Drug Administration.

Limit of detection (LOD) means the lowest concentration of analyte that can be confirmed by the approved regulatory method.

Marker residue means the residue selected for assay whose concentration is in a known relationship to the concentration of the residue of carcinogenic concern in the last tissue to deplete to its Sm.

No residue means the marker residue is below the limit of detection using the approved regulatory method. The “no residue” designation applies only to compounds of carcinogenic concern.

Preslaughter withdrawal period or milk discard time means the time after cessation of administration of the sponsored compound at which no residue is detectable in the edible product using the approved regulatory method (i.e., the marker residue is below the LOD).

Regulatory method means the aggregate of all experimental procedures for measuring and confirming the presence of the marker residue of the sponsored compound in the target tissue of the target animal.

Rm means the concentration of the marker residue in the target tissue when the residue of carcinogenic concern is equal to Sm.

Residue means any compound present in edible tissues of the target animal which results from the use of the sponsored compound, including the sponsored compound, its metabolites, and any other substances formed in or on food because of the sponsored compound's use.

Residue of carcinogenic concern means all compounds in the total residue of a demonstrated carcinogen excluding any compounds judged by FDA not to present a carcinogenic risk.

Sm means 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. For the purpose of § 500.84(c)(1), FDA will assume that this Sm will correspond to the concentration of residue in a specific edible tissue that corresponds to a maximum lifetime risk of cancer in the test animals of 1 in 1 million.

So means the concentration of a residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to the human consumer. For the purpose of § 500.84(c)(1), FDA will assume that this So will correspond 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.

Sponsor means the person or organization proposing or holding an approval by FDA for the use of a sponsored compound or the person initiating a request for an import tolerance under § 510.205 of this chapter.

Sponsored compound means any drug or food additive or color additive proposed for use, or used, in food-producing animals or in their feed.

Target animals means the production class of animals in which a sponsored compound is proposed or intended for use.

Target tissue means the edible tissue selected to monitor for residues in the target animals, including, where appropriate, milk or eggs.

Test animals means the species selected for use in the toxicity tests.

Threshold assessment means FDA's review of data and information about a sponsored compound to determine whether chronic bioassays in test animals are necessary to resolve questions concerning the carcinogenicity of the compound.