(a) When used in this part, the following terms are defined to mean:

(1) Import (imported). To bring within the territorial limits of the United States whether that arrival is accomplished by land, air, or water.

(2) Offer(ed) for entry. The point at which the importer presents the imported product for reinspection.

(3) Entry (entered). The point at which imported product offered for entry receives reinspection and is marked with the official mark of inspection, as required by § 327.26.

(b) The provisions of this part shall apply to products derived from cattle, sheep, swine, goats, horses, mules, and other equines, if capable of use as human food. Compliance with the conditions for importation of products under this part does not excuse the need for compliance with applicable requirements under other laws, including the provisions in parts 94, 95, and 96 of chapter I of this title.

(a)(1) Whenever it shall be determined by the Administrator that the system of meat inspection maintained by any foreign country, with respect to establishments preparing products in such country for export to the United States, insures compliance of such establishments and their products with requirements equivalent to all the inspection, building construction standards, and all other provisions of the Act and the regulations in this subchapter which are applied to official establishments in the United States, and their products, and that reliance can be placed upon certificates required under this part from authorities of such foreign country, notice of that fact will be given in accordance with paragraph (b) of this section. Thereafter, products prepared in such establishments which are certified and approved in accordance with paragraph (a)(3) of this section, shall be eligible so far as this subchapter is concerned for importation into the United States from such foreign country after applicable requirements of this subchapter have been met.

(2) The determination of acceptability of a foreign meat inspection system for purposes of this section shall be based on an evaluation of the foreign program in accordance with the following requirements and procedures:

(i) The system shall have a program organized and administered by the national government of the foreign country. The system as implemented must provide standards equivalent to those of the Federal system of meat inspection in the United States with respect to:

(A) Organizational structure and staffing, so as to insure uniform enforcement of the requisite laws and regulations in all establishments throughout the system at which products are prepared for export to the United States;

(B) Ultimate control and supervision by the national government over the official activities of all employees or licensees of the system;

(C) The assignment of competent, qualified inspectors;

(D) Authority and responsibility of national inspection officials to enforce the requisite laws and regulations governing meat inspection and to certify or refuse to certify products intended for export;

(E) Adequate administrative and technical support;

(F) The inspection, sanitation, quality, species verification, and residue standards applied to products produced in the United States.

(G) Other requirements of adequate inspection service as required by the regulations in this subchapter.

(ii) The legal authority for the system and the regulations thereunder shall impose requirements equivalent to those governing the system of meat inspection organized and maintained in the United States with respect to:

(A) Ante-mortem inspection of animals for slaughter and inspection of methods of slaughtering and handling in connection with slaughtering which shall be performed by veterinarians or by other employees or licensees of the system under the direct supervision of the veterinarians;

(B) Post-mortem inspection of carcasses and parts thereof at time of slaughter, performed by veterinarians or other employees or licensees of the system under the direct supervision of veterinarians;

(C) Official controls by the national government over establishment construction, facilities, and equipment;

(D) Direct and continuous official supervision of slaughtering and preparation of product, by the assignment of inspectors to establishments certified under paragraph (a)(3) of this section, to assure that adulterated or misbranded product is not prepared for export to the United States;

(E) Complete separation of establishments certified under subparagraph (3) of this paragraph from establishments not certified and the maintenance of a single standard of inspection and sanitation throughout all certified establishments;

(F) Requirements for sanitation at certified establishments and for sanitary handling of product;

(G) Official controls over condemned material until destroyed or removed and thereafter excluded from the establishment;

(H) A Hazard Analysis and Critical Control Point (HACCP) system, as set forth in part 417 of this chapter.

(I) Other matters for which requirements are contained in the Act or regulations in this subchapter.

(iii) Countries desiring to establish eligibility for importation of product into the United States may request a determination of eligibility by presenting copies of the laws and regulations on which the foreign meat inspection system is based and such other information as the Administrator may require with respect to matters enumerated in paragraphs (a)(2) (i) and (ii) of this section. Determination of eligibility is based on a study of the documents and other information presented and an initial review of the system in operation by a representative of the Department using the criteria listed in paragraphs (a)(2) (i) and (ii) of this section. Maintenance of eligibility of a country for importation of products into the United States depends on the results of periodic reviews of the foreign meat inspection system in operation by a representative of the Department, and the timely submission of such documents and other information related to the conduct of the foreign inspection system, including information required by paragraph (e) of section 20 of the Act, as the Administrator may find pertinent to and necessary for the determinations required by this section of the regulations.

(iv) The foreign inspection system must maintain a program to assure that the requirements referred to in this section, equivalent to those of the Federal system of meat inspection in the United States, are being met. The program as implemented must provide for the following:

(A) Periodic supervisory visits by a representative of the foreign inspection system to each establishment certified in accordance with paragraph (a)(3) of this section to ensure that requirements referred to in paragraphs (a)(2)(ii)(A) through (H) of this section are being met: Provided, That such visits are not required with respect to any establishment during a period when the establishment is not operating or is not engaged in producing products for exportation to the United States;

(B) Written reports prepared by the representative of the foreign inspection system who has conducted a supervisory visit, documenting his or her findings with respect to the requirements referred to in (A) through (H) of paragraph (a)(2)(ii) of this section, copies of which shall be made available to the representative of the Department at the time of that representative's review upon request by that representative to a responsible foreign meat inspection official: Provided, That such reports are not required with respect to any establishment during a period when the establishment is not operating or is not engaged in producing products for exportation to the United States; and

(C) Random sampling of internal organs and fat of carcasses at the point of slaughter and the testing of such organs and fat, for such residues having been identified by the exporting country's meat inspection authorities or by this Agency as potential contaminants, in accordance with sampling and analytical techniques approved by the Administrator: Provided, That such testing is required only on samples taken from carcasses from which meat or meat food products intended for importation into the United States are produced.

(3) Only those establishments that are determined and certified to the Agency by a responsible official of the foreign meat inspection system as fully meeting the requirements of paragraphs (a)(2)(i) and (ii) of this section are eligible to have their products imported into the United States. Establishment eligibility is subject to review by the Agency (including observations of the establishments by Program representatives at times prearranged with the foreign meat inspection system officials). Foreign establishment certifications must be renewed annually. Notwithstanding certification by a foreign official, the Administrator may terminate the eligibility of any foreign establishment for the importation of its products into the United States if it does not comply with the requirements listed in paragraphs (a)(2)(i) and (ii) of this section, or if current establishment information cannot be obtained. The Administrator will provide reasonable notice to the foreign government of the proposed termination of any foreign establishment, unless a delay in terminating its eligibility could result in the importation of adulterated or misbranded product.

(i) For a new establishment, or any establishment for which information from last year's electronic certification or paper certificate has changed, the certification or certificate must contain: The date; the foreign country; the foreign establishment's name, address, and foreign establishment number; the foreign official's title and signature (for paper certificates only); the type of operations conducted at the establishment (e.g., slaughter, processing, storage, exporting warehouse); and the establishment's eligibility status (e.g., new or relisted (if previously delisted)). Slaughter and processing establishment certifications must address the species and type of products produced at the establishment (e.g., the process category).

(ii) If the establishment information provided on the preceding year's electronic foreign establishment certification or paper certificate, as required in paragraph (a)(3)(i) of this section, has not changed, the certification or certificate must contain: The date, the foreign country, the foreign establishment's name, and the foreign official's title and signature (for paper certificates only).

(4) Meat and meat food products from foreign countries not deemed eligible in accordance with paragraph (b) of this section are not eligible for importation into the United States, except as provided by § 327.16 or § 327.17. Eligibility of any foreign country under this section may be withdrawn whenever the Administrator determines that the system of meat inspection maintained by such foreign country does not assure compliance with requirements equivalent to all the inspection, building construction standards, and other requirements of the Act and the regulations in this subchapter as applied to official establishments in the United States; or that reliance cannot be placed upon certificates required under this part from authorities of such foreign country; or that, for lack of current information concerning the system of meat inspection being maintained by such foreign country, such foreign country should be required to reestablish its eligibility.

(b) A list of countries eligible to export specific process categories of meat and meat food products is maintained at http://www.fsis.usda.gov/importlibrary. Meat and meat food products from listed countries must be accompanied by foreign inspection certificates of the country of origin, as required by § 327.4, and are eligible under the regulations in this subchapter for entry into the United States after inspection and marking as required by the applicable provisions of this part. Fresh, chilled, or frozen or other product from countries in which rinderpest, foot-and-mouth disease or African swine fever exist, as provided in part 94 of this title, are ineligible for importation into the United States.

(a) No product offered for importation from any foreign country shall be admitted into the United States if it is adulterated or misbranded or does not comply with all the requirements of this subchapter that would apply to it if it were a domestic product.

(b) No cooked or partially cooked meat or meat trimmings, either in separable pieces or molded into larger forms, shall be permitted entry except under the following conditions:

(1) A complete procedure for preparing and handling the product in the foreign country and en route to the United States shall be submitted by the exporter or his authorized agent to the Administrator and determined by the Administrator to be adequate to assure that the product will not be adulterated or misbranded at the time of offer for entry.

(2) A system acceptable to the Administrator (upon his determination that the system will provide a reliable indication of the kinds and numbers of microorganisms present) for the microbiological testing of the finished product shall be installed by the processor, the product is subjected to such testing, and the results thereof are furnished to the Administrator and are acceptable to him as showing that the product has been prepared and handled in a sanitary manner.

(c) [Reserved]

(a) Except as provided in § 327.16, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product.

(b) An official of the foreign government must certify that any product described on any official certificate was produced in accordance with the regulatory requirements in § 327.2.

(c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product's arrival at the official import inspection establishment, and be available to import inspection personnel.

(d) The paper foreign inspection certificate must accompany each consignment; be submitted to import inspection personnel at the official import inspection establishment; be in English; bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue inspection certificates for products imported to the United States.

(e) The electronic foreign inspection certification and paper foreign inspection certificate must contain:

(1) The date;

(2) The foreign country of export and the producing foreign establishment number;

(3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country;

(4) The product's description, including the process category, the product category, and the product group;

(5) The name and address of the importer or consignee;

(6) The name and address of the exporter or consignor;

(7) The number of units (pieces or containers) and the shipping or identification mark on the units;

(8) The net weight of each lot; and

(9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States.

(a) Applicants must submit an import inspection application, to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form.

(b) Import inspection applications for each consignment must be submitted (electronically or on paper) to FSIS in advance of the shipment's arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection.

(c) The provisions of this section do not apply to products that are exempted from inspection by §§ 327.16 and 327.17.

(a)(1) Except as provided in §§ 327.16 and 327.17, all products offered for entry from any foreign country shall be reinspected by a Program inspector before they shall be allowed entry into the United States.

(2) Every lot of product shall routinely be given visual inspection by a Program import inspector for appearance and condition, and checked for certification and label compliance.

(3) The electronic inspection system shall be consulted for reinspection instructions. The electronic inspection system will assign reinspection levels and procedures based on established sampling plans and established product and plant history.

(4) When the inspector deems it necessary, the inspector may sample and inspect lots not designated by the electronic inspection system.

(b) All products, required by this part to be inspected, shall be inspected only at an official establishment or at an official import inspection establishment approved by the Administrator as provided in this section. Such approved official import inspection establishments will be listed in the Directory of Meat and Poultry Inspection Program Establishments, Circuits and Officials, published by the Food Safety and Inspection Service. The listing will categorize the kind or kinds of product 2 which may be inspected at each official import inspection establishment, based on the adequacy of the facilities for making such inspections and handling such products in a sanitary manner.

(c) Owners or operators of establishments, other than official establishments, who want to have import inspections made at their establishments, shall apply to the Administrator for approval of their establishments for such purpose. Application shall be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC, and shall include all information called for by that form.

(d) Approval for Federal import inspection shall be in accordance with part 304 of this subchapter.

(e) Owners or operators of official import inspection establishments must furnish adequate sanitary facilities and equipment for examination of such product. The requirements of §§ 304.2, 307.1, 307.2(b), (d), (f), (h), (k), and (l), and part 416 of this chapter shall apply as conditions for approval of establishments as official import inspection establishments to the same extent and in the same manner as they apply with respect to official establishments.

(f) The Administrator is authorized to approve any establishment as an official import inspection establishment provided that an application has been filed and drawings have been submitted in accordance with the requirements of paragraphs (c) and (d) of this section and he determines that such establishment meets the requirements under paragraph (e) of this section. Any application for inspection under this section may be denied or refused in accordance with the rules of practice in part 500 of this chapter.

(g) Approval of an official import inspection establishment may be withdrawn in accordance with applicable rules of practice if it is determined that the sanitary conditions are such that the product is rendered adulterated, that such action is authorized by section 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), or that the requirements of paragraph (e) of this section were not complied with. Approval may also be withdrawn in accordance with section 401 of the Act and applicable rules of practice.

(h) A special official number shall be assigned to each official import inspection establishment. Such number shall be used to identify all products inspected and passed for entry at the establishment.

(i) A sampling inspection shall be made, as provided in paragraph (a) of this section, of foreign chilled fresh or frozen fresh meat, including defrosting if necessary to determine its condition. Inspection standards for foreign chilled fresh or frozen fresh meat shall be the same as those used for domestic chilled fresh or frozen fresh meat. (See § 327.21)

(j) Imported canned products are required to be sound, healthful, properly labeled, wholesome, and otherwise not adulterated at the time the products are offered for importation into the United States. Provided other requirements of this part are met, the determination of the acceptability of the product and the condition of the containers shall be based on the results of an examination of a statistical sample drawn from the consignment as provided in paragraph (a) of this section. If the inspector determines, on the basis of the sample examination, that the product does not meet the requirements of the Act and regulations thereunder, the consignment shall be refused entry. However, a consignment rejected for container defects but otherwise acceptable may be reoffered for inspection under the following conditions:

(1) If the defective containers are not indicative of an unsafe and unstable product as determined by the Administrator;

(2) If the number and kinds of container defects found in the original sample do not exceed the limits specified for this purpose in FSIS guidelines; and

(3) If the defective containers in the consignment have been sorted out and exported or destroyed under the supervision of an inspector.

(k) Program inspectors or Customs officers at border or seaboard ports shall report the sealing of cars, trucks, or other means of conveyance, and the sealing or identification of containers of foreign product on Form MP-410 to Program area supervisors at points where such product is to be inspected.

(l) Representative samples of canned product designated by the Administrator in instructions to inspectors shall be incubated under supervision of such inspectors in accordance with § 318.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii) and (d)(1)(viii) of this subchapter. The importers or his/her agent shall provide the necessary incubation facilities in accordance with § 318.309(d)(1)(i) of this subchapter.

(m) Sampling plans and acceptance levels as prescribed in paragraphs (j) and (l) of this section may be obtained, upon request, from International Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

(a) No product required by this part to be inspected shall be moved, prior to inspection from any port, or, if arriving by water from the wharf where first unloaded, to any place other than the place designated by, or in accordance with, this part as the place where the same shall be inspected.

(b) No product required by this part to be inspected shall be conveyed, prior to inspection, from any port, or, if arriving by water, from the wharf where first unloaded, in any manner other than in compliance with this part.

(c) No product required by this part to be inspected shall be delivered to the consignee or his agent prior to inspection, unless the consignee shall furnish a bond, in form prescribed by the Secretary of the Treasury, conditioned that the product shall be returned, if demanded, to the collector of the port where the same is offered for clearance through the customs.

(d) The consignee or his agent shall provide such assistance as Program inspectors may require for the handling and marking of product offered for entry.

Compartments of steamships, sailing vessels, railroad cars, and other means of conveyance transporting any product to the United States, and all trucks, chutes, platforms, racks, tables, tools, utensils, and all other devices used in moving and handling any product offered for importation into the United States, shall be maintained in a sanitary condition.

Burlap shall not be used as a wrapping for foreign meat unless the meat is first wrapped with a good grade of paper or cloth of a kind which will prevent contamination with lint or other foreign material.

(a) Program inspectors may take, without cost to the United States, for laboratory examination, samples of any product which is subject to analysis, from each consignment offered for importation, except that such samples shall not be taken of any product offered for importation under § 327.16.

(b) Except for product offered for entry from Canada, the outside containers of all products offered for entry from any foreign country and accompanied with a foreign inspection certificate as required by this part, which, upon reinspection by import inspectors are found not to be adulterated or misbranded and are otherwise eligible for entry into the United States under this part, or the products themselves if not in containers, shall be marked with the official inspection legend prescribed in § 327.26 of this part. Except for Canadian product, all other products so marked, in compliance with this part, shall be entered into the United States, insofar as such entry is regulated under the Act.

(c) Product which is inspected and rejected shall be marked “U.S. Refused Entry” as shown in § 327.26(c). Such marks shall be applied to the shipping container or the product itself if not in a container.

(d) The inspection legend may be placed on containers of product before completion of official import inspection if the containers are being inspected by an import inspector who reports directly to an Import Field Office Supervisor; the product is not required to be held at the establishment pending the receipt of laboratory test results; and a written procedure for controlled stamping, submitted by the import establishment and approved by the Director, Import Inspection Division, is on file at the import inspection facility where the inspection is to be performed.

(1) The written procedure for controlled pre-stamping should be in the form of a letter and shall include the following:

(i) That stamping under this part will be limited to those lots of product which can be inspected on the day that certificates for the product are examined;

(ii) That all product which has been pre-stamped will be stored in the facility where the import inspection will occur;

(iii) That inspection marks applied under this part will be removed from any lot of product subsequently refused entry on the day the product is rejected; and

(iv) That the establishment will maintain a daily stamping log containing the following information for each lot of product: the date of inspection, the country of origin, the foreign establishment number, the product name, the number of units, the shipping container marks, and the MP-410 number covering the product to be inspected. The daily stamping log must be retained by the establishment in accordance with the requirements of § 320.3.

(2) An official import establishment's controlled pre-stamping privilege may be cancelled orally or in writing by the inspector or other Agency employee who is supervising its enforcement whenever the employee finds that the official import establishment has failed to comply with the provisions of this part or any conditions imposed pursuant thereto. If the cancellation is oral, the decision or action and the reasons therefor will be confirmed in writing, as promptly as circumstances allow. Any person whose controlled pre-stamping privilege has been cancelled may appeal the decision or action in accordance with 9 CFR 500.9. The appeal must state all of the facts and reasons upon which the person relies to show that the controlled pre-stamping privilege was wrongfully cancelled.

In order that importers may be assured that samples of foreign products collected for laboratory examination are to be used exclusively for that purpose, official receipts shall be issued and delivered to importers, or their agents, by inspectors for all samples of foreign products collected. The official receipt shall be prepared in duplicate, over the signature of the inspector who collects the samples, and shall show the name of the importer, country of origin, quantity and kind of product collected, date of collection, and that the sample was collected for laboratory examination. The duplicate copy of the receipt shall be retained by the inspectors as their office record.

(a) Samples of foreign canned or packaged products bearing on their immediate containers trade labels which have not been approved under § 317.3 of this subchapter shall be collected and forwarded to the laboratory by the Program inspector for examination, and the products shall be held pending receipt of the report of the laboratory findings and the results of the examination of trade labels and the marks on shipping containers.

(b) Foreign canned or packaged products bearing trade labels and other markings which have been approved under § 317.3 of this subchapter shall be inspected for soundness and checked for net weight. Samples may be collected for laboratory examination, but the products may be released under customs' bond pending the report of laboratory findings.

(c) Samples shall be taken from foreign canned products or packaged products as required by § 327.6 (a) and (j) of this part.

(a)(1) Program inspectors shall report their findings as to any product which has been inspected in accordance with this part, to the Director of Customs at the original port of entry where the same is offered for clearance through Customs inspection.

(2) When product has been identified as “U.S. refused entry, ” the inspector shall request the Director of Customs to refuse admission to such product and to direct that it be exported by the owner or consignee within the time specified in this section, unless the owner or consignee, within the specified time, causes it to be destroyed by disposing of it under the supervision of a Program employee so that the product can no longer be used as human food, or by converting it to animal food uses, if permitted by the Food and Drug Administration. The owner or consignee of the refused entry product shall not transfer legal title to such product, except to a foreign consignee for direct and immediate exportation, or to an end user, e.g., an animal food manufacturer or a renderer, for destruction for human food purposes. “Refused entry” product must be delivered to and used by the manufacturer or renderer within the 45-day time limit. Even if such title is illegally transferred, the subsequent purchaser will still be required to export the product or have it destroyed as specified in the notice under paragraph (a)(5) of this section.

(3) No lot of product which has been refused entry may be subdivided during disposition pursuant to paragraph (a)(2) of this section, except that removal and destruction of any damaged or otherwise unsound product from a lot destined for reexportation is permitted under supervision of USDA prior to exportation. Additionally, such refused entry lot may not be shipped for export from any port other than that through which the product came into the United States, without the expressed consent of the Administrator based on full information concerning the product's disposition, including the name of the vessel and the date of export. For the purposes of this paragraph, the term “lot” shall refer to that product indentified on MP Form 410 in the original request for inspection for importation pursuant to § 327.5.

(4) Product which has been refused entry solely because of misbranding, in lieu of exportation or destruction pursuant to paragraph (a)(2) of this section, may be brought into compliance with the requirements of this part, under supervision of an authorized representative of the Administrator.

(5) The owner or consignee shall have 45 days after notice is given by FSIS to the Director of Customs at the original port of entry to take the action required in paragraph (a)(2) of this section for “refused entry” product. Extension beyond the 45-day period may be granted by the Administrator when extreme circumstances warrant it; e.g., a dock workers' strike or an unforeseeable vessel delay.

(6) If the owner or consignee fails to take the required action within the time specified under paragraph (a)(5) of this section, the Department will take such action as may be necessary to effectuate its order to have the product destroyed for human food purposes. The Department shall seek court costs and fees, storage, and proper expense in the appropriate legal forum.

(7) No product which has been refused entry and exported to another country pursuant to paragraph (a)(2) of this section may be returned to the United States under any circumstance. Any such product so returned to the United States shall be subject to administrative detention in accordance with section 402 of the Act and seizure and condemnation in accordance with section 403 of the Act.

(b) Upon the request of the Director of Customs at the port where a product is offered for clearance through the customs, the consignee of the product shall, at the consignee's own expense, immediately return to the Director any product which has been delivered to consignee under § 327.7 and subsequently designated “U.S. Refused Entry” or found in any respect not to comply with the requirements in this part.

(c) All charges for storage, cartage, and labor with respect to any product which was imported contrary to the Act shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against such product and any other product thereafter imported by or for such owner or consignee.

(a) Product which is offered for importation, and which is susceptible of marking, shall, whether or not enclosed in an immediate container, bear the name of the country of origin, preceded by the words “product of”; the establishment number assigned by the foreign meat inspection system and certified to the Program; and such other markings as are necessary for compliance with part 316 of this subchapter. When such markings are imprints of stamps or brands made with branding ink, such ink shall be harmless and shall create permanent imprints. In case the name of the country of origin appears as part of an official mark of the national foreign government and such name is prominently and legibly displayed, the words “product of” may be omitted.

(b) In addition to the marking of products required under paragraph (a) of this section, the immediate container of any product offered for importation:

(1) Shall bear a label showing in accordance with § 317.2 of this subchapter all information required by that section (except that the establishment number assigned by the foreign meat inspection system and certified to the Program and the official inspection mark of the foreign meat inspection system shall be shown instead of the official inspection legend of the United States) and in addition the name of the country of origin preceded by the words “product of,” immediately under the name or descriptive designation of the product as required by § 317.2: Provided, That such establishment number may be omitted from a label lithographed directly on a can if said number is lithographed or embossed elsewhere on the can; and

(2) Shall, if such immediate container is a sealed metal container, have the establishment number assigned by the foreign meat inspection authority and certified by the Program embossed or lithographed on the sealed metal container, and such establishment number shall not be covered or obscured by any label or other means.

(c) All marks and other labeling for use on or with immediate containers, as well as private brands on carcasses or parts of carcasses, must be approved by the Food Safety and Inspection Service in accordance with part 412 of this chapter before products bearing such marks, labeling, or brands will be entered into the United States. The marks of inspection of foreign systems embossed on metal containers or branded on carcasses or parts thereof need not be submitted to the Food Safety and Inspection Service for approval, and such marks of inspection put on stencils, box dies, labels, and brands may be used on such immediate containers as tierces, barrels, drums, boxes, crates, and large-size fiberboard containers of foreign products without such marks of inspection being submitted for approval, provided the markings made by such articles are applicable to the product and are not false or misleading.

(a) The outside container in which any immediate container of foreign product is shipped to the United States shall bear, in English, in a prominent and legible manner:

(1) The name or descriptive designation of the product in accordance with § 317.2 of this subchapter;

(2) The name of the country of origin; and

(3) The establishment number assigned by the foreign meat inspection system and certified to the Program.

(b) All labeling used with an outside container of foreign product must be approved in accordance with part 317 of this subchapter.

(c) Except for product offered for entry from Canada, all outside containers of products which have been inspected and passed in accordance with this part shall be marked by a Program import inspector or under a Program import inspector's supervision with the official import meat inspection mark prescribed in § 327.26.

Any product in a quantity of 50 pounds or less which was purchased by the importer outside the United States for his/her own consumption, is eligible to be imported into the United States from any country without compliance with the provisions in other sections of this part but subject to applicable requirements under other laws, including the regulations in part 94 of this title. However, Program employees may inspect any product imported under this section to determine whether it is within the class eligible to be imported under this paragraph.

U.S. inspected and passed and so marked products exported to and returned from foreign countries will be admitted into the United States without compliance with this part upon notification to and approval of the Deputy Administrator, International Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, in specific cases.

(a) All products, after entry into the United States, shall be deemed and treated as domestic products and shall be subject to the applicable provisions of the Act and the regulations in this subchapter and the applicable requirements under the Federal Food, Drug and Cosmetic Act, except that products imported under § 327.16 are required to comply only with the requirements of that Act and § 327.16 of this subchapter.

(b) Products entered in accordance with this part may, subject to the provisions of part 318 of this subchapter, be taken into official establishments and be mixed with or added to any product in such establishments which has been inspected and passed therein.

(c) Imported product which has been inspected, passed, and marked under this part may be transported in the course of importation or subsequently in commerce only upon compliance with part 325 of this subchapter.

The provisions in this part do not apply to specimens of products for laboratory examination, research, or similar purposes when authorized importation by the Administrator under conditions specified by him in specific cases, including requirements of denaturing or other identification to deter their use for human food. Authorization will not be given for the importation of any products contrary to the provisions of part 94 of this chapter.

No inedible grease, inedible tallow, or other inedible rendered fat shall be imported into the United States unless it has been first denatured as prescribed in § 327.25 of this part and the containers marked as prescribed by § 316.15 of this subchapter or unless it is identified and handled as prescribed by § 325.11 (b) or (c) of this subchapter.

(a) Definitions; sampling; standards. (1) Frozen boneless manufacturing meat is meat, frozen in the fresh state from cattle, sheep, swine, goats, horses, mules, or other equines that has all bone removed and is cut into pieces or trimmings, frozen into a compact block of any shape and suitable for slicing or chopping in the manufacturing of meat food products. As used in this section, the term “frozen” includes “chilled fresh,” and “lot” means any amount of frozen boneless manufacturing meat of one species, similarly packaged, shipped from one establishment, and offered for import inspection under one or more foreign inspection certificates.

(2) Imported frozen boneless manufacturing meat shall be sampled as required by § 327.6(a) of this part, and the samples defrosted for inspection. The Program import inspector, or in the case of Canadian product subject to procedures described in § 327.5(d)(1), the Canadian representative will select from a lot the appropriate number of cartons specified by the table of sampling plans. The total sample for inspection will consist of the necessary number of 12-pound units drawn from these cartons. The 12-pound units selected will be completely defrosted and examined.

(b) Lots refused entry. Reinspection (including resampling) will be provided for any lot of frozen boneless manufacturing meat which was refused entry under this section on the basis of the original evaluation of the sample thereof, upon appeal from the inspector's initial decision.

(a) Definitions. For the purposes of this section:

(1) A Product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading “Product Name and Qualifying Statements” in the chart in § 319.104 or § 319.105 of this subchapter.

(2) A Product Group or a Group means one of the following:

(i) Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product that fits into the Group shall be placed in this Group regardless of any other considerations.

(ii) Group II, consisting of cured pork products which have been water cooked. Any product that does not fit into Group I but does fit into Group II shall be placed into Group II regardless of any other considerations.

(iii) Group III, consisting of boneless, smokehouse heated cured pork products. Any boneless product that does not fit into Group I or II shall be placed in Group III.

(iv) Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product and does not fit into Group I, II, or III shall be placed in this Group.

(3) Protein Fat-Free Percentage, Protein Fat-Free Content, PFF Percentage, PFF Content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product.

(4) A PFF Standardized Difference is the PFF of the sample minus the minimum PFF requirement, set forth in § 319.104 and § 319.105 of this subchapter, for the product being analyzed, divided by the Appropriate Standard Deviation for the product group.

(5) The Absolute Minimum PFF Requirement is that no laboratory result of an individual sample for PFF content be below the applicable minimum requirement of § 319.104 or § 319.105 of this subchapter by 2.3 or more percentage points for a Group I or II product or 2.7 or more percentage points for a Group III or IV product.

(6) A PFF Standardized Arithmetic Average of the Country's Products is the arithmetic average of PFF Standardized Differences from either 36 or 100 consecutively sampled lots of product entering the United States from a given producing country.

(7) A PFF Standardized Weighted Average of the Country's Products is an estimate of the average of the PFF Standardized Differences from either 36 or 100 consecutively sampled lots, adjusted for the size of the lot, of different types of cured pork product entering the United States from a given producing country. A Standardized Weighted Average is computed by multiplying the PFF Standardized Difference calculated for each lot by the number of pounds of product in each lot, adding those results together, and dividing the sum by the total weight of product from all the lots making up the average.

(8) The Appropriate Standard Deviation is based on within lot variability. That assigned to Groups I and II = 0.75 percent PFF and that assigned to Groups III and IV = 0.91 percent PFF.

(9) A Lot is all product of one type from one establishment presented by an importer as the unit for inspection at the Port of Entry.

(b) Normal monitoring procedures. Except for product imported from Canada, the Department shall collect sample(s) of cured pork product on a random basis from lots offered for entry at the Port of Entry and, after analyzing the sample for fat and indigenous protein content, calculate the PFF percentage. The product shall not be held pending laboratory results during the monitoring phase. The PFF percentage for each sample shall be considered along with the cumulative results of prior samples to assess the effectiveness of a country's overall compliance program and to determine the course of action for subsequent lots of product.

(1) Factors determining whether a country's inspection system is functioning adequately:

(i) The PFF percentage for each sample must not be below the minimum PFF requirement by 2.3 percentage points for cured pork products in Groups I and II or 2.7 percentage points for cured pork products in Groups III and IV.

(ii) Both of the PFF Standardized Averages, Arithmetic and Weighted, for the last 100 consecutive lots of all cured pork products from the country must be equal to or greater than zero. The count for the 100 consecutive lots starts with the lots arriving from that country after April 15, 1985.

(iii) Both of the PFF Standardized Averages, Arithmetic and Weighted, for the last 36 consecutive lots of all cured pork products from the country must be above the lowest 5 percent of the Normal distribution. This minimum value is minus 0.28 (−0.28) for the Arithmetic Average and depends on the production volume for the Weighted Average.

(2) Actions when calculations indicate that processing procedures in a country are out-of-compliance:

(i) If the PFF level of a sample taken during normal monitoring procedures is found to be as low as the Absolute Minimum PFF Requirement, the country of origin shall be notified; the lot involved shall be retained if still available in an official establishment or subject to detention or other actions pursuant to the Act; and all subsequently presented lots of that cured pork product from the same foreign establishment shall be held under retention until the provisions of paragraph (c) are satisfied.

(ii) If either of the PFF Standardized Averages, Arithmetic or Weighted, for the last 100 consecutive lots falls below zero or either of the PFF Standardized Averages for the last 36 consecutive lots falls below the upper 95 percent of the Normal distribution, all available cured pork product from the foreign country shall be subject to administrative retention and all subsequently presented lots of cured pork product from the foreign country shall be held under retention until the provisions of paragraph (c) are satisfied. The country of origin shall be notified, and shall be subject to other actions pursuant to the Act.

(c) Retention. When lots of cured pork product are under retention they shall be refused entry and reexported in accordance with § 327.13 of this subchapter unless they can be released in accordance with the provisions of paragraph (c)(1), establishments may be returned to normal monitoring procedures in accordance with paragraph (c)(2), and countries may be returned to normal monitoring procedures in accordance with paragraph (c)(3).

(1) If a lot is subject to retention procedures under this section, the Department shall collect five randomly selected sample units from each lot and determine the PFF of each sample unit. The lot may be released into commerce if:

(i) The average PFF percentage of the five randomly selected sample units is equal to or greater than the applicable minimum PFF percentage required by § 319.104 or § 319.105 of this subchapter, or

(ii) The product is relabeled under the supervision of a program employee so that it conforms to the provisions of § 319.104 or § 319.105 of this subchapter.

(2) If product from a foreign establishment is subject to retention procedures under this section, the foreign establishment may be returned to normal monitoring procedures when:

(i) Ten consecutively presented lots of that cured pork product from that establishment have been sampled as provided in paragraph (c)(1) of this section and the average of each set of five sample units representing each lot have been found to be equal to or greater than the required minimum PFF percentage; and

(ii) The PFF percentage of each sample unit (50 in all) is above the Absolute Minimum PFF Percentage.

(3) If a country is subject to retention procedures under this section, the country shall be returned to normal monitoring procedures when:

(i) Twenty-five consecutively presented lots of cured pork product have been sampled as required in paragraph (c)(1) of this section and the average of each set of five sample units representing each lot have been found to be equal to or greater than the required minimum PFF percentage; and

(ii) The PFF percentage of each sample unit (125 in all) is above the Absolute Minimum PFF Percentage; and

(iii) Both of the PFF Standardized Averages for 36 consecutive lots are in the required percentage of the Normal distribution; and

(iv) Both of the PFF Standardized Averages for 100 consecutive lots are zero or higher.

(4) The sample units collected under retention procedures as provided in paragraph (c)(2) of this section will not be included in the PFF standardized averages for 36 and 100 consecutive lots.

(d) Adulterated and Misbranded Products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act (21 U.S.C. 601(m)(8)) and misbranded under section 1(n) of the Act (21 U.S.C. 601(n)).

(e) Activities requiring additional inspectional supervision, such as relabeling, shall be at the importer's expense. In addition, if the importer wishes, he or she may have samples analyzed at an accredited laboratory.

Any appeal of a decision or action of any program employee will be made to his/her immediate supervisor having responsibility over the subject matter of the appeal in accordance with 9 CFR 500.9.

(a) Carcasses, parts thereof, meat and meat food products (other than rendered animal fats) that have been treated in accordance with the provisions of this section shall be considered denatured for the purposes of the regulations in this part, except as otherwise provided in part 314 of this subchapter for articles condemned at official establishments or at official import inspection establishments.

(1) The following agents are prescribed for denaturing carcasses, parts thereof, meat or meat food products which are affected with any condition that would result in their condemnation and disposal under part 314 of this subchapter if they were at an official establishment or at an official import inspection establishment: Crude carbolic acid; cresylic disinfectant; a formula consisting of 1 part FD&C green No. 3 coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella, or other proprietary substance approved by the Administrator in specific cases. 1

(2) Meat may be denatured by dipping it in a solution of 0.0625 percent tannic acid, followed by immersion in a water bath, then dipping it in a solution of 0.0625 percent ferric acid; and except as provided in paragraphs (a) (3) and (5) of this section, the following agents are prescribed for denaturing other carcasses, parts thereof, meat and meat food products, for which denaturing is required by this part: FD&C green No. 3 coloring; FD&C blue No. 1 coloring; FD&C blue No. 2 coloring; finely powdered charcoal; or other proprietary substance approved by the Administrator in specific cases. 1 Carcasses (other than viscera), parts thereof, cuts of meat, and unground pieces of meat darkened by charcoal or other black dyes shall be deemed to be denatured pursuant to this section only if they contain at least that degree of darkness depicted by diagram 1 of the Meat Denaturing Guide (MP Form 91). 2

(3) Tripe may be denatured by dipping it in a 6 percent solution of tannic acid for 1 minute followed by immersion in a water bath, then immersing it for 1 minute in a solution of 0.022 percent FD&C yellow No. 5 coloring.

(4) When meat, meat byproducts, or meat food products are in ground form, 4 percent by weight of coarsely ground hard done, which shall be in pieces no smaller than the opening size specified for No. 5 mesh in the standards issued by the U.S. Bureau of Standards or 6 percent by weight of coarsely ground hard bone, which shall be in pieces no smaller than the opening size specified for No. 8 mesh in said Standards, uniformly incorporated with the product, may be used in lieu of the agents prescribed in paragraph (a)(2) of this section.

(5) Before the denaturing agents are applied to articles in pieces more than 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or sectioning will not be necessary.) The application of any of the denaturing agents listed in paragraph (a) (1) or (2) of this section to the outer surface of molds or blocks or boneless meat, meat by-products, or meat food products shall not be adequate. The denaturing agent must be mixed intimately with all the material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.

(b) Inedible rendered animal fats shall be denatured by thoroughly mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, finely powdered charcoal, or any proprietary denaturing agent approved for the purpose by the Administrator in specific cases. The charcoal shall be used in no less quantity than 100 parts per million and shall be of such character that it will remain suspended indefinitely in the liquid fat. Sufficient of the chosen identifying agents shall be used to give the rendered fat so distinctive a color, odor, or taste that it cannot be confused with an article of human food.

(a) When import inspections are performed in official import inspection establishments, the official inspection legend to be applied to imported meat and meat food products shall be in the appropriate form 1 as herein specified.

For application to cattle, sheep, swine, and goat carcasses, primal parts, and cuts, not in containers.

For application to outside containers of meat and meat food products prepared from cattle, sheep, swine, and goats.

For application to horse carcasses, primal parts, and cuts, not in containers.

For application to outside containers of horsemeat food products.

For application to mule and other (nonhorse) equine carcasses, primal parts, and cuts, not in containers.

For application to outside containers of equine meat food products.

(b) Except for product offered for entry from Canada, when import inspections are performed in official establishments the official inspection legend to be applied to meat and meat food products offered for entry shall be the appropriate form as specified in §§ 312.2 and 312.3 of this subchapter.

(c) When products are refused entry into the United States, the official mark to be applied to the products refused entry shall be in the following form:

(d) Devices for applying “United States Refused Entry” marks shall be furnished to Program inspectors by the Department.

(e) The ordering and manufacture of brands containing official inspection legends shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations.