19 U.S. Code § 2575b - Subpart definitions

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Notwithstanding section 2571 of this title, for purposes of this subpart—
(1) Animal
The term “animal” includes fish, bees, and wild fauna.
(2) Approval procedure
The term “approval procedure” means any registration, notification, or other mandatory administrative procedure for—
(A) approving the use of an additive for a stated purpose or under stated conditions, or
(B) establishing a tolerance for a stated purpose or under stated conditions for a contaminant,
in a food, beverage, or feedstuff prior to permitting the use of the additive or the marketing of a food, beverage, or feedstuff containing the additive or contaminant.
(3) Contaminant
The term “contaminant” includes pesticide and veterinary drug residues and extraneous matter.
(4) Control or inspection procedure
The term “control or inspection procedure” means any procedure used, directly or indirectly, to determine that a sanitary or phytosanitary measure is fulfilled, including sampling, testing, inspection, evaluation, verification, monitoring, auditing, assurance of conformity, accreditation, registration, certification, or other procedure involving the physical examination of a good, of the packaging of a good, or of the equipment or facilities directly related to production, marketing, or use of a good, but does not mean an approval procedure.
(5) Plant
The term “plant” includes wild flora.
(6) Risk assessment
The term “risk assessment” means an evaluation of—
(A) the potential for the introduction, establishment or spread of a pest or disease and associated biological and economic consequences; or
(B) the potential for adverse effects on human or animal life or health arising from the presence of an additive, contaminant, toxin or disease-causing organism in a food, beverage, or feedstuff.
(7) Sanitary or phytosanitary measure
(A) In general
The term “sanitary or phytosanitary measure” means a measure to—
(i) protect animal or plant life or health in the United States from risks arising from the introduction, establishment, or spread of a pest or disease;
(ii) protect human or animal life or health in the United States from risks arising from the presence of an additive, contaminant, toxin, or disease-causing organism in a food, beverage, or feedstuff;
(iii) protect human life or health in the United States from risks arising from a disease-causing organism or pest carried by an animal or plant, or a product thereof; or
(iv) prevent or limit other damage in the United States arising from the introduction, establishment, or spread of a pest.
(B) Form
The form of a sanitary or phytosanitary measure includes—
(i) end product criteria;
(ii) a product-related processing or production method;
(iii) a testing, inspection, certification, or approval procedure;
(iv) a relevant statistical method;
(v) a sampling procedure;
(vi) a method of risk assessment;
(vii) a packaging and labeling requirement directly related to food safety; and
(viii) a quarantine treatment, such as a relevant requirement associated with the transportation of animals or plants or with material necessary for their survival during transportation.

Source

(Pub. L. 96–39, title IV, § 463, as added Pub. L. 103–182, title III, § 351(a),Dec. 8, 1993, 107 Stat. 2119.)

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21 CFR - Food and Drugs

21 CFR Part 20 - PUBLIC INFORMATION

 

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