§531.1. Definitions.

Amenable species. A species that is, and whose products are, subject to the Act and regulations promulgated under the Act, except as the Act may provide.

Animal food. Any article intended for use as food for dogs, cats, or other animals, derived wholly, or in part, from the carcass or parts or products of the carcass of any amenable species, except that the term animal food as used herein does not include:

Biological residue. Any substance, including metabolites, remaining in fish at time of slaughter or in any of their tissues after slaughter as the result of treatment or exposure of the fish to a pesticide, organic or inorganic compound, hormone, hormone like substance, anthelmintic, or other therapeutic or prophylactic agent.

Capable of use as human food. This term applies to any carcass or part or product of a carcass of any fish unless it is denatured or otherwise identified as required by § 540.3 of this subchapter to deter its use as a human food, or it is naturally inedible by humans; e.g., barbels or fins in their natural state.

Carcass. All parts, including viscera, of any slaughtered livestock.

Commerce. Commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia.

Consumer package. Any container in which a fish product is enclosed for the purpose of display and sale to household consumers.

Container. Any box, can, tin, cloth, plastic, or any other receptacle, wrapper, or cover.

Dead fish. The body of a fish that has died otherwise than by slaughter.

Dying or diseased fish. Fish affected by any of the conditions for which the fish are required to be condemned under part 539 or other regulations in this subchapter.

Edible. Intended for use as human food.

Farm-raised. Grown under controlled conditions, within an enclosed space, as on a farm.

Federal Food, Drug, and Cosmetic Act. The Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto.

Firm. Any partnership, association, or other unincorporated business organization.

Fish. (1) For the purposes of this subchapter, any fish of the order Siluriformes, whether live or dead.

Fish byproduct. Any fish part capable of use as human food, other than the skeletal muscle tissue, that has been derived from one or more fish.

Fish food product. Any article capable of use as human food that is made wholly or in part from any fish or part thereof; or any product that is made wholly or in part from any fish or part thereof, excepting those exempted from definition as a fish product by the Administrator in specific cases or by a regulation in this subchapter; upon a determination that they contain fish ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the fish food industry, and provided that they comply with any requirements that are imposed in such cases or regulations as conditions of such exemptions to ensure that the fish meat or other portions of such carcasses contained in such articles are not adulterated, and that such articles are not represented as fish food products.

Fish product. Any fish or fish part; or any product that is made wholly or in part from any fish or fish part, except for those exempted from definition as a fish product by the Administrator in a regulation in this subchapter. Except where the context requires otherwise (e.g., in part 540 of this subchapter), this term is limited to articles capable of use as human food.

Further processing. Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously prepared in official establishments.

Immediate container. The receptacle or other covering in which any product is directly contained or wholly or partially enclosed.

Inedible. Adulterated, uninspected, or not intended for use as human food.

“Inspected and passed” or “U.S. Inspected and Passed” or “U.S. Inspected and Passed by Department of Agriculture” (or any authorized abbreviation thereof). This term means that the product so identified has been inspected and passed under the regulations in this subchapter, and at the time it was inspected, passed, and identified, it was found to be not adulterated.

Label. A display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.

Labeling. All labels and other written, printed, or graphic matter:

Nonfood compound. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of fish food and fish products excluding labeling and packaging materials as covered in part 541 of this subchapter.

Official certificate. Any certificate prescribed by the regulations in this subchapter for issuance by an inspector or other person performing official functions under the Act.

Official device. Any device prescribed by the regulations in part 312 of this subchapter for use in applying any official mark.

Official establishment. Any slaughtering, cutting, boning, fish product canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter.

Official import inspection establishment. This term means any establishment, other than an official establishment as defined in this section, where inspections are authorized to be conducted as prescribed in part 557 of this subchapter.

Official inspection legend. Any symbol prescribed by the regulations in this subchapter showing that an article was inspected and passed in accordance with the Act.

Official mark. The official inspection legend or any other symbol prescribed by the regulations in this subchapter to identify the status of any article, fish, or fish product under the Act.

Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for fish products.

Person. Any individual, firm, or corporation.

Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for purposes of the Act and the regulations in this subchapter as under the Federal, Drug, and Cosmetic Act.

Prepared. Slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed.

Process authority. A person or organization with expert knowledge in fish production process control and relevant regulations. This definition does not apply to § 548.6 of this subchapter or to subpart G of part 318 of this chapter.

Process schedule. A written description of processing procedures, consisting of any number of specific, sequential operations directly under the control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production. This definition does not apply to § 548.6 of this subchapter or to subpart G of part 318 of this chapter.

Producer. Any person engaged in the business of growing farm-raised fish.

Product. Any carcass, fish, fish product, or fish food product, capable of use as human food.

Program. The organizational unit within the Department having the responsibility for carrying out the provisions of the Act.

Program employee. Any inspector or other individual employed by the Department or any cooperating agency who is authorized by the Secretary to do any work or perform any duty in connection with the Program.

Slaughter. With respect to fish, intentional killing under controlled conditions.

State. Any State of the United States or the Commonwealth of Puerto Rico.

Territory. Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States.

U.S. Condemned. This term means that the fish, part, or product of fish so identified was inspected and found to be adulterated and is condemned.

U.S. Detained. This term applies to fish, fish products, and other articles which are held in official custody in accordance with section 402 of the Act (21 U.S.C. 672), pending disposal as provided in the same section 402.

U.S. Retained. This term means that the fish, part, or product of fish so identified is held for further examination by an inspector at an official establishment to determine its disposal.

United States. The States, the District of Columbia, and the Territories of the United States.