compliance with labeling requirements. Any finding of false or misleading labeling shall institute the proceedings prescribed in § 381.233.

(b) Generically approved labeling is labeling which complies with the following:

(1) Labeling for a product which has a product standard as specified in subpart 381 of this subchapter or the Standards and Labeling Policy Book and which does not contain any special claims, such as quality claims, nutrient content claims, health claims, negative claims, geographical origin claims, or guarantees, or which is not a domestic product labeled in a foreign language;

(2) Labeling for single-ingredient products (such as chicken legs or turkey breasts) which does not contain any special claims, such as quality claims, nutrient content claims, health claims, negative claims, geographical origin claims, or guarantees, or which is not a domestic product labeled with a foreign language;

(3) Labeling for containers of products sold under contract specifications to Federal Government agencies, when such product is not offered for sale to the general public, provided that the contract specifications include specific requirements with respect to labeling, and are made available to the inspector-in-charge;

(4) Labeling for shipping containers which contain fully labeled immediate containers, provided such labeling complies with §381.127;

(5) Labeling for products not intended for human food, provided they comply with §§ 381.152(c) and 381.193, and labeling for poultry heads and feet for export for processing as human food if they comply with §381.190(b);

(6) Poultry inspection legends, which comply with subpart M of this part;

as sketch labeling, and the final labeling was prepared without modification or with the following modifications:

(1) All features of the labeling are proportionately enlarged or reduced, provided that all minimum size requirements specified in applicable regulations are met and the labeling is legible;

(ii) The substitution of any unit of measurement with its abbreviation or the substitution of any abbreviation with its unit of measurement, e.g., "lb.' for "pound," or "Oz." "ounce," or of the word "pound" for "lb." or "ounce” for “oz.";

for

(iii) A master or stock label has been approved from which the name and address of the distributor are omitted and such name and address are applied before being used (in such case, the words "prepared for" or similar statement must be shown together with the blank space reserved for the insertion of the name and address when such labels are offered for approval);

(iv) Wrappers or other covers bearing pictorial designs, emblematic designs or illustrations, e.g., floral arrangements, illustrations of animals, fireworks, etc. are used with approved labeling (the use of such designs will not make necessary the application of labeling not otherwise required);

(v) A change in the language or the arrangement of directions pertaining to the opening of containers or the serving of the product;

(vi) The addition, deletion, or amendment of a dated or undated coupon, a cents-off statement, cooking instructions, packer product code information, or UPC product code information;

(vii) Any change in the name or address of the packer, manufacturer or distributor that appears in the signature line;

(viii) Any change in the net weight, provided that the size of the net weight statement complies with §381.121;

(ix) The addition, deletion, or amendment of recipe suggestions for the product;

(x) Any change in punctuation;

(xi) Newly assigned or revised establishment numbers for a particular establishment for which use of the labeling has been approved by the Food Labeling Division, Regulatory Programs;

(xii) The addition or deletion of open dating information;

(xiii) A change in the type of packaging material on which the label is printed;

(xiv) Brand name changes, provided that there are no design changes, the brand name does not use a term that connotes quality or other product characteristics, the brand name has no geographic significance, and the brand name does not affect the name of the product;

(xv) The deletion of the word "new" on new product labeling;

or

(xvi) The addition, deletion, amendment of special handling statements, provided that the change is consistent with §381.125(a);

(xvii) The addition of safe handling instructions as required by §381.125(b); (xviii) Changes reflecting a change in the quantity of an ingredient shown in the formula without a change in the order of predominance shown on the label, provided that the change in quantity of ingredients complies with any minimum or maximum limits for the use of such ingredients prescribed in § 381.147 and subpart P of this part;

(xix) Changes in the color of the labeling, provided that sufficient contrast and legibility remain;

(xx) A change in the product vignette, provided that the change does not affect mandatory labeling information or misrepresent the content of the package;

(xxi) The addition, deletion, or substitution of the official USDA poultry grade shield; (xxii) A change in the establishment number by a corporation or parent company for an establishment under its ownership;

(xxiii) Changes in nutrition labeling that only involve quantitative adjustments to the nutrition labeling information, except for services sizes, provided the nutrition labeling information maintains its accuracy and consistency;

(xxiv) Deletion of any claim, and the deletion of non-mandatory features or non-mandatory information;

(xxv) The addition or deletion of a direct translation of the English lan

§ 381.134 Requirement of formulas.

Copies of each label submitted for approval, shall when the Administrator requires in any specific case, be accompanied by a statement showing, by their common or usual names, the kinds and percentages of the ingredients comprising the poultry product and by a statement indicating the method or preparation of the product with respect to which the label is to be used. Approximate percentages may be given in cases where the percentages of ingredients may vary from time to time, if the limits of variation are stated.

[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 45196, Sept. 1, 1994. Redesignated at 60 FR 67457, Dec. 29, 1995]

§ 381.135 Irradiated poultry product.

(a) The labeling of packages of poultry product irradiated in conformance with §381.147(f)(4) of this part must bear the following logo along with a statement such as, "Treated with radiation" or "Treated by irradiation,” in addition to all other labeling requirements of this subpart. The logo must be placed prominently and conspicuously in conjunction with the required statement and be colored green. The statement must appear as a qualifier contiguous to the product name and in letters of the same style, color, and type as the product name. Letters used for the qualifying statement shall be no less than one-third the size of the largest letter in the product name. Any labeling bearing the logo and any wording of explanation with respect to this logo must be approved as required by subparts M and N of this part.

(b) The product label must bear the handling statement "Keep Refrigerated" or "Keep Frozen," as appropriate, in conformance with §381.125 of this subpart.

(c) Optional labeling statements about the purpose for radiation processing may be included on the product label in addition to the above stated requirements. Such statements must not be false or misleading.

[57 FR 43597, Sept. 21, 1992]

§ 381.136 Affixing of official identification.

(a) No official inspection legend or any abbreviation or other simulation thereof may be affixed to or placed on or caused to be affixed to or placed on any poultry product or container thereof, except by an inspector or under the supervision of an inspector E or other person authorized by the Administrator, and no container bearing any such legend shall be filled except under such supervision.

(b) No official inspection legend shall be used on any poultry product or other article which does not qualify for such mark under the regulations.

§ 381.137 Evidence of labeling and devices approval.

No inspector shall authorize the use of any device bearing any official inspection legend unless he or she has on file evidence that such device has been approved in accordance with the provisions of this subpart.

[60 FR 67458, Dec. 29, 1995]

§381.138 Unauthorized use or disposition of approved labeling or devices.

(a) Labeling and devices approved for use pursuant to §381.115 shall be used only for the purpose for which approved, and shall not be disposed of from the official establishment for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved labeling or devices bearing official inspection marks is prohibited and may result in cancellation of the approval.

(b) Labeling and containers bearing any official inspection marks, with or without the official establishment number, may be transported from one official establishment to any other official establishment, only if such shipments are made with the prior authorization of the inspector in charge at point of origin, who will notify the inspector in charge at destination concerning the date of shipment, quantity, and type of labeling material involved. Approved labeling and containers may be moved without restriction under this part between official establishments operated by the same person if such labeling and containers are approved for use at all such establishments. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subpart.

§ 381.139 Removal of official identifications.

(a) Every person who receives any poultry product in containers which bear any official inspection legend shall remove or deface such legend or destroy the containers upon removal of such articles from the containers.

(b) No person shall alter, detach, deface, or destroy any official identifications prescribed in subpart M that were applied pursuant to the regulations, unless he is authorized to do so by an inspector or this section; and no person shall fail to use any such official identification when required by this part.

§ 381.140 Relabeling poultry products.

When it is claimed by the operator of an official establishment that some of its labeled poultry product, which has been transported to a location other

than an official establishment, is in need of relabeling because the labeling has become mutilated or damaged, or for some other reason needs relabeling, the requests for relabeling the poultry product shall be sent to the Administrator and accompanied with a statement of the reasons therefor and the quantity of labeling required. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Administrator. The relabeling of inspected and passed product with official labels shall be done under the supervision of an inspector pursuant to the regulations in part 362 of this chapter. The establishment shall reimburse the Inspection Service for any cost involved in supervising the relabeling of such product as provided in said regulations.

§§ 381.141-381.143 [Reserved]

§ 381.144 Packaging materials.

may

(a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which render the contents adulterated or injurious to health. All packaging materials must be safe for the intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA).

(b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific

shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty.

(c) The guaranty by the packaging supplier will be accepted by Program inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations.

(d) The Department will monitor the use of packaging materials in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information to designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not proIvided within the time indicated in the request a minimum of 30 days-any applicable guaranty shall cease to be effective and approval to continue using the specified packaging material

in official establishments may be denied. The Administrator may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers.

(e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with the FFDCA and applicable food additive regulations. Before approval to use = a packaging material is finally denied

by the Administrator, the affected offiEcial establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not acccept the Administrator's determina

tion, a hearing in accordance with applicable rules of practice will be held to I resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing Eshall be denied if the Administrator determines that such use may present an imminent hazard to public health.

(f) Periodically, the Administrator will issue to inspectors a listing, by distinguishing brand name or code des“ ignation, of packaging materials that E have been reviewed and that fail to meet the requirements of paragraph (a) of this section. Listed materials will not be permitted for use in official esI tablishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (a), the material will be deleted from the listing.

Subpart O-Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements

§ 381.145 Poultry products and other articles entering or at official establishments; examination and other requirements.

(a) No poultry product (including poultry broth for use in any poultry product in any official establishment) may be brought into any official establishment unless it has been processed in the United States only in an official establishment or imported from a foreign country listed in §381.196(b), and inspected and passed, in accordance with the regulations; and unless the container of such product is marked so as to identify the product as so inspected and passed, in accordance with §381.115 or §381.205, except that poultry products inspected and passed and identified as such under the laws of an "at least equal" State or territory listed in §381.187 may be brought into any official establishment solely for storage and distribution therefrom without repackaging, relabeling, or processing in such establishment. No carcass, part thereof, meat or meat food product of cattle, sheep, swine, goats, or equines may be brought into an official establishment unless it has been prepared in the United States only in an official meat packing establishment, or imported, and inspected and passed, in accordance with the Federal Meat Inspection Act, and the regulations under such Act (Subchapter A of this chapter) and is properly marked as so inspected and passed; or has been inspected and passed and is identified as such in accordance with the requirements of the law and regulations of a State not designated in §331.2 of this chapter; or is present in the official establishment by reason of an exemption allowed in the Federal Meat Inspection Act and the regulations under such Act (Subchapter A of this chapter) or the