no nutrition claims or nutrition information,

(5) Products custom slaughtered or prepared,

(6) Products intended for export, and (7) The following products prepared and served or sold at retail provided that the labels or the labeling of these products bear no nutrition claims or nutrition information:

(i) Ready-to-eat products that are packaged or portioned at a retail store or similar retail-type establishment; and

(ii) Multi-ingredient products (e.g., sausage) processed at a retail store or similar retail-type establishment.

(b) Restaurant menus generally do not constitute labeling or fall within the scope of these regulations.

(c)(1) Foods represented to be specifically for infants and children less than 2 years of age shall bear nutrition labeling as provided in paragraph (c)(2) of this section, except such labeling shall not include calories from fat, calories from saturated fat, saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat, and cholesterol. (2) Foods represented or purported to be specifically for infants and children less than 4 years of age shall bear nutrition labeling except that:

(i) Such labeling shall not include declarations of percent of Daily Value for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber;

(ii) Nutrient names and quantitative amounts by weight shall be presented in two separate columns;

(iii) The heading "Percent Daily Value" required in §317.309(d)(6) shall be placed immediately below the quantitative information by weight for protein;

(iv) The percent of the Daily Value for protein, vitamins, and minerals shall be listed immediately below the heading "Percent Daily Value"; and

(v) Such labeling shall not include the footnote specified in § 317.309(d)(9). (d)(1) Products in packages that have a total surface area available to bear labeling of less than 12 square inches are exempt from nutrition labeling, provided that the labeling for these products bear no nutrition claims or other nutrition information. The man

ufacturer, packer, or distributor shall provide, on the label of packages that qualify for and use this exemption, an address or telephone number that a consumer can use to obtain the required nutrition information (e.g., "For nutrition information call 1-800123-4567").

(2) When such products bear nutrition labeling, either voluntarily or because nutrition claims or other nutrition information is provided, all required information shall be in a type size no smaller than 6 point or all upper case type of 16-inch minimum height, except that individual servingsize packages of meat products that have a total area available to bear labeling of 3 square inches or less may provide all required information in a type size no smaller than 32-inch minimum height.

[58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995]

318.1 Products and other articles entering official establishments.

318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.

318.3 Designation of places of receipt of products and other articles for reinspection.

318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.

318.5 Requirements concerning procedures. 318.6 Requirements concerning ingredients and other articles used in preparation of products.

318.7 Approval of substances for use in the preparation of products.

318.8 Preservatives and other substances

permitted in product for export only; handling; such product not to be used for domestic food purposes.

318.9 Samples of products, water, dyes, chemicals, etc., to be taken for examination.

318.10 Prescribed treatment of pork and products containing pork to destroy trichinae.

318.11 [Reserved]

318.12 Manufacture of dog food or similar uninspected article at official establishments.

318.13 Mixtures containing product but not amendable to the Act. 318.14 Adulteration of product by polluted water; procedure for handling.

318.15 Tagging chemicals, preservatives, cereals, spices, etc., "U.S. retained." 318.16 Pesticide chemicals and other residues in products.

318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef products.

318.18 Handling of certain material for mechanical processing.

318.19 Compliance procedure for cured pork products.

318.20 Use of animal drugs.

318.21 Accreditation of chemistry labora

tablishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this subparagraph, product imported in accordance with part 327 of this subchapter and not prepared in the United States outside an official establishment, may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the Program employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with §318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under $318.3, until it has been reinspected by the inspector.

(b) No slaughtered poultry or poultry product shall be brought into an official establishment unless it has been (1) previously inspected and passed and is identified as such in accordance with the requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the regulations thereunder, and has not been prepared other than in an establishment inspected under said Act, or (2) has been inspected and passed and is identified as such in accordance with the requirements of a State law.

(c) Every article for use as an ingredient in the preparation of meat food products, when entering any official establishment and at all times while it is in such establishment, shall bear a label showing the name of the article, the amount or percentage therein of any substances restricted by this part or part 317 of this subchapter, and a list of ingredients in the article if composed of two or more ingredients: Provided, That in the case of articles received in tank car lots, only one such label shall be used to identify each lot. In addition, the label must show the name and address of the shipper.

(d) To ensure the safe use of preparations used in hog scalding water or in

the denuding of tripe, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or Subchapter E.

(e) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment.

(f) [Reserved]

(g) Glands and organs, such cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packaged in suitable containers so that the presence of such glands and organ will in no way interfere with the maintenance of sanitary conditions or constitute an interference with inspection. Glands or orIgans which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic or technical purposes, only if U.S. inspected and passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in §318.12(a).

(h)(1) Carcasses of game animals, and carcasses derived from the slaughter by any person of livestock of his own raising in accordance with the exemption provisions of paragraph 23(a) of the Act, and parts of such carcasses, may be brought into an official establishment for preparation, packaging, and storing in accordance with the provisions of $303.1(a)(2) of this subchapter.

be

(i) The operator of the official establishment shall furnish such information as is necessary to determine the origin of any product or other article entering the official establishment. Such information shall include, but is not limited to, the name and address of the seller or supplier, transportation company, agent, or broker involved in the sale or delivery of the product or article in question.

(j) Any product or any poultry or poultry product or other article that is brought into an official establishment contrary to any provision of this section may be required by the Administrator to be removed immediately from such establishment by the operator thereof, and failure to comply with such requirement shall be deemed a violation of this regulation. If any slaughtered poultry or poultry products or other articles are received at an official establishment and are suspected of being adulterated or misbranded under the Poultry Products Inspection Act or the Federal Food, Drug, and Cosmetic Act, or applicable State laws, the appropriate governmental authorities will be notified.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, 1984; 64 FR 72174, Dec. 23, 1999]

EFFECTIVE DATE NOTE: At 64 FR 72174, Dec. 23, 1999, §318.1, paragraph (d) was revised, effective Jan. 24, 2000. For the convenience of the user, the superseded text is set forth as follows:

(d) Containers of preparations which enter any official establishment for use in hog scalding water or in denuding of tripe shall bear labels showing the chemical names of the preparations. In the case of any preparation containing any of the chemicals which are specifically limited by §318.7(c)(4) as to amount permitted to be used, the labels on the containers must also show the percentage of each such chemical in the preparation and must provide dilution directions which prescribe the maximum allowable use concentration of the preparations.

$318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments.

(a) All products and all slaughtered poultry and poultry products brought into any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment and shall be subject to reinspection by a Program employee at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations in this subchapter.

even

(b) All products, whether fresh, cured, or otherwise prepared, though previously inspected and passed, shall be reinspected by Program employees as often as they may deem necessary in order to ascertain that they are not adulterated or misbranded at the time they enter or leave official establishments and that the requirements of the regulations in this subchapter are complied with.

(c) Reinspection may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The circuit supervisor shall designate the type of plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator. 1

1 Further information concerning sampling plans which have been adopted for specific products may be obtained from the Circuit Supervisors of Program circuits. These sampling plans are developed for individual prod

(d) A U.S. retained tag shall be placed by a Program employee at the time of reinspection at any official establishment on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized Program employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under the regulations in this subchapter, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with part 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall be cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the U.S. retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a U.S. retained tag, or a U.S. detention tag as provided in part 329 of this subchapter, pending correction of the misbranding or issuance of an order under section 7 of the Act to withhold from use the labeling or container of the product, or the institution of a judicial seizure action under section 403 of Act or other appropriate action. The inspector shall make a complete record

ucts by the Washington staff and will be distributed for field use as they are developed. The type of plan applicable depends on factors such as whether the product is in containers, stage of preparation, and procedures followed by the establishment operator. The specific plan applicable depends on the kind of product involved, such as liver, oxtails. etc.

of each transaction under this paragraph and shall report his action to the area supervisor.

[35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971]

$318.3 Designation of places of receipt

of products and other articles for reinspection.

Every official establishment shall designate, with the approval of the circuit supervisor, a dock or place at which products and other articles subject to reinspection under §318.2 shall be received, and such products and articles shall be received only at such dock or place.

$318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control.

(a) All processes used in curing, pickling, rendering, canning, or otherwise preparing any product in official establishments shall be supervised by Program employees unless such preparation is conducted as a custom operation exempted from inspection under §303.1(a)(2) of this subchapter in any official establishment or consists of operations that are exempted from inspection under $303.1(d) of this subchapter and are conducted in a retail store in an establishment subject to inspection only because the State or Territory in which the establishment is located is designated under paragraph 301(c) of the Act. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products.

(b) It shall be the responsibility of the operator of every official establishment to comply with the Act and the regulations in this subchapter. In order to carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to assure the maintenance of the

establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of this subchapter. The effectiveness of such measures will be subject to review by the Department.

(c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing meat food product who has a total plant quality control system or plan for controlling such product, after antemortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include:

(1) A letter to the Administrator from the establishment owner of operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control system requires it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary.

(2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of an establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will be