(a) No livestock used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless:
(1) The operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Program, or the Veterinary Services unit of the Animal and Plant Health Inspection Service of the Department of Agriculture or to the Environmental Protection Agency or to the Food and Drug Administration of the Department of Health, Education, and Welfare, data or a summary evaluation of the data which demonstrates that the use of such biological product, drug, or chemical will not result in the products of such livestock being adulterated, and a Program employee has approved such slaughter;
(2) Written approval by the Deputy Administrator, Meat and Poultry Inspection Field Operations is furnished the area supervisor prior to the time of slaughter;
(3) In the case of an animal administered any unlicensed, experimental veterinary biologic product regulated under the Virus-Serum Toxin Act (21 U.S.C. 151 et seq.), the product was prepared and distributed in compliance with Part 103 of the regulations issued under said Act ( part 103 of this title ), and used in accordance with the labeling approved under said regulations;
(4) In the case of an animal administered any investigational drug regulated under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), the drug was prepared and distributed in compliance with the applicable provisions of part 135 of the regulations issued under said Act ( 21 CFR part 135 ), and used in accordance with the labeling approved under said regulations;
(5) In the case of an animal subjected to any experimental economic poison under section 2(a) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 135 et seq.), the product was prepared and distributed in accordance with § 362.17 of the regulations issued under said Act ( 7 CFR 362.17 ), and used in accordance with the labeling approved under said regulations.
(6) In the case of an animal administered or subjected to any substance that is a food additive or pesticide chemical under the Federal Food, Drug, and Cosmetic Act, supra, there has been compliance with all tolerance limitations established by said Act and the regulations promulgated thereunder ( 21 CFR 1.1 et seq.), and all other restrictions and requirements imposed by said Act and said regulations will be complied with at the time of slaughter.
(b) The inspector in charge may deny or withdraw the approval for slaughter of any livestock subject to the provision of this section when he deems it necessary to assure that all products prepared at the official establishment are free from adulteration.
Title 9 published on 2013-01-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.