21 CFR § 500.82 - Definitions.
(a) The definitions and interpretations contained in section 201 of the act apply to those terms when used in this subpart.
(b) The following definitions apply to this subpart:
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.
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.
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.
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.
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.
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