PART 531—DEFINITIONS Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 2.18, 2.53. § 531.1 Definitions. As used in this subchapter, unless otherwise required by the context, the following terms shall be construed, respectively, to mean: Act. et seq. Adulterated. (1) If it bears or contains any such poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; (2)(i) If it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance (other than one which is: (A) A pesticide chemical in or on a raw agricultural commodity; (B) A food additive; or (C) A color additive which may, in the judgment of the Administrator, make such article unfit for human food; (ii) If it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act; (iii) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act; (iv) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Provided, That an article which is not deemed adulterated under paragraphs (2)(ii), (iii), or (iv) of this definition shall nevertheless be deemed adulterated if use of the pesticide chemical food additive, or color additive in or on such article is prohibited by the regulations in this subchapter in official establishments; (3) If it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food; (4) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; (5) If it is, in whole or in part, the product of an animal which has died otherwise than by slaughter; (6) If its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; (7) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act; (8) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefore; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. Amenable species. Animal food. (1) Processed dry animal food or (2) Feeds for amenable species manufactured from processed by products of amenable species. Applicant. Biological residue. Capable of use as human food. e.g., Carcass. Commerce. Consumer package. Container. Dead fish. Dying or diseased fish. Edible. Farm-raised. Federal Food, Drug, and Cosmetic Act. Firm. Fish. (2) The skeletal muscle tissue of fish. As applied to products of fish of the order Siluriformes, this term has a meaning comparable to that of “meat” in the meat inspection regulations (9 CFR 301.2). Fish byproduct. Fish food product. Fish product. e.g., Further processing. Immediate container. Inedible. “Inspected and passed” or “U.S. Inspected and Passed” or “U.S. Inspected and Passed by Department of Agriculture” (or any authorized abbreviation thereof). Label. Labeling. (1) Upon any article or any of its containers or wrappers, or (2) Accompanying such article. Misbranded. (1) If its labeling is false or misleading in any particular; (2) If it is offered for sale under the name of another food; (3) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated; (4) If its container is so made, formed, or filled as to be misleading; (5) If in a package or other container unless it bears a label showing: (i) The name and place of business of the manufacturer, packer, or distributor; and (ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in part 317 of this subchapter with respect to the quantity of contents; (6) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (7) If it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by the regulations in part 319 of this subchapter unless: (i) It conforms to such definition and standard, and (ii) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food; (8) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by the regulations in part 319 of this subchapter, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; (9) If it is not subject to the provisions of paragraph (7)(ii) of this definition unless its label bears: (i) The common or usual name of the food, if any there be, and (ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient, except as otherwise provided in part 317 of this subchapter; (10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as is required by the regulations in part 317 of this subchapter. (11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided by the regulations in part 317 of this subchapter; or (12) If it fails to bear, directly thereon or on its containers, when required by the regulations in part 316 or 317 of this subchapter, the inspection legend and, unrestricted by any of the foregoing, such other information as the Administrator may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition. Nonfood compound. Official certificate. Official device. Official establishment. Official import inspection establishment. Official inspection legend. Official mark. Packaging material. Person. Pesticide chemical, food additive, color additive, raw agricultural commodity. Prepared. Process authority. Process schedule. Producer. Product. Program. Program employee. Slaughter. State. Territory. U.S. Condemned. U.S. Detained. U.S. Retained. United States. [80 FR 75616, Dec. 2, 2015]