This instruction provides import inspection personnel with guidelines on the requirements and procedures for the reinspection of imported meat and poultry products for labeling compliance.

Companies exporting to the United States must adhere to the labeling standards incorporated in the Federal meat and poultry inspection regulations and policies. Companies will be fully accountable for the content and production of all labels, whether generically approved, modified without resubmission, or submitted to FSIS for review and approval. FSIS's Labeling and Consumer Protection Staff (LCPS) develops policies and inspection methods and administers programs to protect consumers from misbranded and economically adulterated meat and poultry products. Further guidance on labeling issues may be obtained by accessing "A Guide to Federal Food Labeling Requirements of Meat and Poultry" found at http://www.fsis.usda.gov/pdf/Labeling_Requirements_Guide.pdf.

Part 2, Section 2, "Label Compliance for Imported Meat and Poultry Products," dated October 30, 2006. 
Part 2, Labeling Declaration Requirements: "For Cooking Only" dated May 16, 2008.
 

3. FORMS

FSIS Form 7234-1, "Application for Approval of Labels, Marking or Device," dated 10/03/2002. Available at: http://www.fsis.usda.gov/fsisforms/7234-1.pdf

4. APPROVAL OF LABELS OF FOREIGN MEAT AND POULTRY PRODUCTS

   1. Foreign establishments are responsible for ensuring the accuracy of labeling for all products exported to the United States. Foreign inspection systems will:

      • verify that each establishment maintains complete labeling records

      • Verify labeling practices that result in compliance with current FSIS labeling regulations and policies

      • Ensure that animal production or raising claims, such as Free Range or Grass-fed, which are made by the producers and applied to the label are truthful and accurate.

   2. Foreign establishments certified as eligible to export to the United States by a foreign inspection system have the authority to use generically approved labeling for the following in accordance with 9 CFR 317.5 and 381.133:

      1. Product which has a standard of identity and which does not contain any special claims;

      2. Single-ingredient products which do not contain special claims;

      3. Product sold under contract specifications to Federal Government agencies;

      4. Shipping containers which contain fully labeled immediate containers;

      5. Products not intended for human food;

      6. Inspection legends;

      7. Inserts, tags, liners, pasters, and like devices, and protective coverings that contain no reference to product and bear no misleading features;

      8. Consumer test products;

      9. Modifications as per 9CFR 317.5(b)(9)(i-xxiv); and

      10. Previously approved sketch labeling.

3. Labels which display any printing, lithographing, embossing, stickers, seals or other written matter upon an immediate container (except for inspection legends or foreign establishment numbers printed or stamped on casings, bags, or wrappers) must be submitted for approval to FSIS, LCPS. Sketch labeling with the following special claims such as quality, nutrient content, health, negative, geographic origin and animal production must be submitted for sketch approval. Requests for temporary approvals must also be sent to LCPS. Refer to FSIS Directive 7221.1, "Procedures for Preparing and Submitting Label Application by Establishments Requesting Label Approvals" or to the instructions provided on the FSIS web site: ( (http://www.fsis.usda.gov/OPPDE/larc/index.htm)  for complete procedures for requesting label approvals.

A shipping container is an outside container (box, bag, barrel, crate, or other receptacle for covering) containing or wholly or partly enclosing any product packed in one or more immediate containers (per 9 CFR 301.2). This includes imported meat and poultry products packed in bulk or in protective coverings.

1. Labeling Requirements - Shipping Containers

   1. Shipping container labels must have, in a prominent and legible manner, the following information:

      1. Name or descriptive designation of the product.

• as the species of origin (i.e., Beef);

• as species without identifying the primal or subprimal when certain terms associated with various portions are part of the product name (i.e., pork chop, pork cutlet, beef steak, lamb filet, beef roast);

• as species and primal or subprimal cut (i.e. pork shoulder butt collar);

• as species, primal or subprimal cut and coin name (i.e., butt, cala, daisy, picnic, etc.). The species and coin name are not appropriate as a complete product name since it is missing the primal or subprimal cut (i.e., "pork shoulder picnic" is incomplete without "shoulder").
  
• as species with generic designation (e.g. Boneless Beef Boneless Cuts (cut name), Bone In Beef Cuts (cut name), etc). For example: in cases such as this, a foreign health certificate could state "Boneless Beef Tenderloins," and the shipping container could be labeled "Boneless Beef Cuts" or vice versa.
  
Note: Single ingredient products, such as meat cuts or poultry parts should be grouped by process category/sub-category, such as 03C Cuts ; 03C Bone-in Cuts, 03C Carcasses; or, 03C Organs/Offal/By- products when presented for reinspection.

2. Processed Products.

When the shipping container contains fully labeled immediate containers, the product name on the shipping container label must be the same as it appears on the label of the immediate container. Ingredient statements, 'cured with' statements, 'injected' with statements, and other statements of the same nature are not required on the shipping container when the shipping container contains fully labeled immediate containers.

3. Qualifiers, Claims, Grades

   When a qualifier, special or nutrition claim, or grading terminology is present, import inspection personnel will refer to Part X.D. and Enclosure 1 for guidance. For information related to labeling declarations, refer to Enclosure 3 of this section for guidance.

2. The name of the country of origin, preceded by "Product of." However, if the name of the country appears in the mark of inspection of the foreign country or the shipping container contains fully labeled immediate containers, the phrase "Product of" need not appear;

3. The establishment number assigned by the foreign meat inspection system and certified to FSIS;

4. A shipping mark. This unique mark is used to link the product to the foreign health certificate. Import inspection personnel must refer to Part 4, Section 2,"Document Examination and Identification of Imported Product," of the import manual for procedures concerning identification of product;

5. The name and address of either the foreign establishment, distributor, or importer; unless it appears on the labels of the immediate containers inside the shipping container;

6. A special handling statement, where applicable, such as "KEEP REFRIGERATED", "KEEP FROZEN", "PERISHABLE, KEEP UNDER REFRIGERATION", or such similar statement as LCPS may approve in specific cases (317.2). KEEP CHILLED is not acceptable terminology. Handling statements should be accurate for the product being presented for reinspection or they must be corrected; and

7. Sufficient space on the main panel for the U.S. mark of inspection. NOTE: Not applicable to product from Canada since the U.S. mark of inspection is applied to the health certificate and import application (FSIS Form 9540-1).

NOTE: Hanging carcass loads/lots from Canada may utilize a placard containing the required labeling information. The entire shipping unit (trailer, truck) is considered the shipping container in this situation.

2. Labeling Information

   1. The labeling information must be:

      1. Mechanically printed, stenciled, or stamped directly on the shipping container or on a self-destructive label affixed to the shipping container. Hand written labels or labeling information are not acceptable.

      2. In the English language; however, in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English.

   2. Duplicate labeling information may appear on other panels of the shipping container (e.g. shipping marks may be applied to areas in addition to the principal display panel, including the top of the carton).

   3. If a net weight is declared, it must be in avoirdupois weight (i.e. pounds, ounces) or liquid measure (i.e. fluid ounces, quart). It is acceptable to state the net weight in metric weight in addition to the avoirdupois weight.

6. LABELS OF IMMEDIATE CONTAINERS
   1. Import inspection personnel will examine labels of randomly selected immediate containers. An immediate container is a receptacle or other covering in which any product is directly contained or wholly or partially enclosed (per 9 CFR 301.2) and must include all mandatory labeling features. Import inspection personnel will examine labels of immediate containers to assure that the following mandatory features appear on the label, as required by 9 CFR 317.2 and 381.116.
   2.  The mandatory features include:

1. Name of product (Refer to Enclosure 1 for use of qualifiers considered part of the product name)

2. Ingredients statement, if needed

3. Foreign establishment number

4. Handling statements, such as "keep frozen" or "keep refrigerated", if needed

5. Net quantity of contents, if needed

6. Manufacturer's or distributor's name and address

7. Nutrition labeling, if needed

8. Name of the country of origin, preceded by the words "Product of". NOTE: The phrase "Product of _______" is required on all immediate containers of meat and/or poultry products. The phrase "Product of _______" IS NOT required on a red meat carcass, primal or subprimal cut that prominently displays the name of the foreign country within the marking itself, e.g., the Canadian mark of inspection is a circle surrounding the word Canada and the establishment number.

9. Safe handling instructions for raw and partially cooked meat and poultry products that have not undergone further processing that would render them as ready-to-eat and are destined for the consuming public. Exemptions to this requirement include imported products intended for further processing at an FSIS official establishment and all ready-to-eat products.

7. Protective Coverings

Until further notice, import inspection personnel will contact the Regional Import Field Office (RIFO) when foreign products packaged in protective coverings do not comply with the labeling guidance identified below. Labeling requirements for protective coverings are under review by the Office of Policy, Program, and Employee Development (OPPED) and exceptions will be granted on a case-by-case basis.

At this time, protective covering is defined in FSIS Labeling Policy Memo 090B. The use of protective coverings is intended solely to protect the product against soiling or excessive drying during transportation or storage. Product not destined directly to consumers is exempt from internal examination for protective covering labeling (e.g. Bulk Packed Frozen Boneless Beef).

At this time, protective covering is defined in FSIS Labeling Policy Memo 090B. The use of protective coverings is intended solely to protect the product against soiling or excessive drying during transportation or storage.

1. To qualify as a protective covering exempt from mandatory labeling features, unprocessed red meat products must be:
   • packaged in transparent wrappings
   • bear the country of origin (the words ‘product of’ are not required)
   • bear the foreign establishment number
   Optional information allowed on protective coverings includes:
   • company brand names
   • trade marks
   • code numbers

NOTE: Protective covering do not need to be marked with official mark of inspection if the product is stamped and the stamp is clearly visible through the transparent protective covering
 
2. If any additional information is applied to protective coverings, such as the name of product, ingredient statement, handling statement, safe handling instructions, net weight, manufacturer or distributor name, or nutrition statement, the label will be considered an immediate container and will have to comply with those requirements (refer to V.B).

8. Application of the Import Mark - Carcasses and Primal Parts
   
   Title 9 of the Code of Federal Regulations, Part 327.14 (a) requires that portions of fresh red meat products that are susceptible of being marked bear the official marks of the country of origin, preceded by the words "product of" on each cut of meat. Imported products susceptible of being marked include carcasses, each primal part of a carcass, beef liver, beef tongue, and beef hearts. Primal parts include the wholesale cuts of carcasses as customarily distributed to retailers (9 CFR 316.9(b)).
1. Carcasses and Parts of Carcasses Not Imported in Shipping Cartons
   1. Labeling Requirements

      Labeling carcasses or parts thereof of cattle, sheep, swine, goats, horses, mules or other equine that are not containerized in shipping containers must include:

      • the foreign establishment number
      • a unique shipping mark
      • the name of the country of origin, preceded by the words "Product of "

      If the name of the country of origin appears as part of the foreign country's mark of inspection and is prominently and legibly displayed, the words "Product of" may be omitted. Acceptable methods of labeling may include packaging enclosing the product, a placard on the container, or a tag affixed to each unit of product.

2. Primal Parts
   
   FSIS regulations (9 CFR 316.9) require that each primal part of a carcass and each liver, beef tongue, and beef heart which has been inspected and passed be marked with the official inspection legend containing the number of the official establishment before it leaves the establishment in which it is first inspected and passed.
   
   Primal Parts as defined in 9 CFR 316.9(b)

   Beef	Veal, Mutton, Goat	Pork	Equine
   Round Flank Loin Rib Plate Briskets Chuck Shank	Leg Flank Loin Rack, Breast Shoulder	Ham Loin Belly Shoulder Jowl	Round Loin Flank Rib Plate Brisket Chuck Shank

   
   Boning, trimming or skinning a primal part does not change its muscle tissue content and it continues to be a primal part that requires marking. Primal parts cut into marketable sections or sub-primal parts do not require marking.

9. Unmarked Inspected Product
   1. Unmarked primal parts will be allowed to move from an official foreign establishment, through an official USDA/FSIS import establishment to an official USDA/FSIS production establishment for further processing, provided the shipping container is sealed in a manner to prevent tampering or substitution of product.
      1. If the shipment/load is assigned a type of inspection (TOI), the shipping containers will have to be resealed by the import establishment with tamper proof tape or another acceptable security means.
      2. If import inspection personnel are unaware of the product's final destination, the import establishment plant management or importer of record must verify (in writing) the final destination to inspection personnel.
   2. Options for tamper-proof sealing of shipments of unmarked foreign products which have been inspected and passed but do not bear the official inspection legend on the primal parts include the following:
      1. In fully marked cartons closed with a tape bearing the foreign meat inspection legend. The seal provided by the tape must be such that the container cannot be opened without breaking the seal/tape. (Some polypropylene tape has not been found satisfactory for this purpose on product held under freezer conditions).
      2. In fully marked cartons (non-waxed or waxed) to which a strap has been applied that bears in a permanent manner, the company name and address or foreign country and establishment number.
      3. In fully marked combo bins with a liner that can be sealed with a company seal bearing the company name. The company seal may be a plastic strap or a metallic seal and must be non-removable without breaking the seal or tearing the liner.
      4. In fully marked reusable containers and waxed cartons closed with a company seal bearing the company name and establishment number. Such a company seal must make it very difficult to open these reusable waxed cartons or returnable containers without breaking the seal.
      5. In fully marked containers closed by a pressure sensitive tamper evident label that doubles as a seal. This label sticker will display either the meat inspection legend or a complete label in compliance with shipping container label verification requirements.
      6. In fully marked containers shrink wrapped with a stick-on foreign meat inspection legend or a complete shipping container label on the outside of the shrink wrap.

      Import inspection personnel will HOLD any shipments and contact the RIFO if shipments arrive with any other means of tamper proof sealing the carton/container. The RIFO will determine acceptance of any alternative means of sealing cartons on a case by case basis.

      NOTE: Applying a seal (either government or company) to the transportation vessel is not an acceptable option for tamper-proof sealing.

10. Labeling Verification Procedures (LVP)
    
    Currently, the Automated Import Information System (AIIS) only assigns a Labeling Verification (LVP) type of inspection (TOI) when the shipment receives a product examination inspection assignment. However, every lot of imported meat and/or poultry will be subjected to label verification.
    
    In all cases of performing the LVP-TOI, import inspection personnel must verify labeling compliance for the shipping container, immediate container, and protective covering, including the marking of primal parts.
    1. Sample Selection for LVP
       1. Staged lots
          1. For each staged lot, the import inspector must randomly select samples for LVP from the number of pallet(s), combo bin(s), drum(s), etc., in accordance with Table A.
              

             Number of Pallets, Combos, Drums, Etc. (Lot Size)	Number of Pallets, Combos, Drums, Etc. (Sample Size)
             01-10	1
             11-20	2
             21-30	3
             31-40	4
             41-50	5
             51 or more	5 plus 1 additional sample unit for every increase in lot size by 10 units or parts thereof.

              

          2. Examine the labeling of all shipping containers of the selected pallet(s), combo(s), drum(s), etc. EXAMPLE: For a lot size of 55 pallets, the sample size will be six pallets. The disposition of the lot, with respect to label compliance, will be based on a label examination of all shipping cartons located on the six randomly selected pallets.
          3. If any of the required information (e.g. shipping mark) is not visible on the shipping container during the labeling examination, import inspection personnel will require import establishment management to present the containers in a manner to facilitate examination of all the required features for each container on the selected pallet. If the missing information is determined to be on the containers, then the lot will be accepted.
          4. Examine the labeling inside the shipping container to verify the labeling of immediate containers, protective coverings, and the labeling/marking of primal parts and carcasses. . Product not destined directly to consumers is exempt from internal examination for protective covering labeling (e.g. Bulk Packed Frozen Boneless Beef Trimmings).

          Note: For product (carcasses or parts) offered on pallets, crates, or similar holders, import inspection personnel will randomly select 1 unit (carcass, side, quarter, etc.) from each randomly selected pallet, crate or other similar holder. For product offered on rails or in a similar manner, import inspection personnel will randomly select 1 unit of product (carcass or part).

       2. Skipped Lots from Canada
          1. Skipped lots from Canada are not staged, but import inspection personnel must verify labeling compliance on the product at the rear of the vehicle, including placards, shipping containers, immediate containers, and protective coverings, as applicable.
          2. When a labeling verification TOI is assigned by the AIIS, the lot will have to be off-loaded and staged at the import establishment.
    2. Reporting Results into the AIIS
       1. If the LVP is assigned by the AIIS, import inspection personnel will either "accept" or "reject" this TOI in the AIIS physical results screen, depending on the results of the verification.
       2. If the LVP is not assigned by the AIIS and the TOI fails for any of the stated criteria, import inspection personnel must access the AIIS physical results screen, add an unscheduled Label Verification- Product Examination TOI, and enter the result as rejected in the AIIS physical results screen.
       3. If the LVP is not assigned by the AIIS and the TOI passes for all stated criteria, import inspection personnel will not enter results into the AIIS physical results screen as an unscheduled Label Verification- Product Exam.
    3. Sorting Rejected Lots - AIIS Amendments
       1.  When the importer elects to sort a lot, the import inspector will e-mail the following information to Import Inspection Division (IID) Headquarters (HQ) at ImportInspection@fsis.usda.gov:
          • the AIIS Lot ID number
          • the name of the foreign country
          • the producing establishment number
          • indicate which “rejection” should be removed because the lot is being sorted
       2. The specific lot which failed the LVP-TOI will have the "rejection" removed. This will allow import inspection personnel the opportunity to enter a "Partial Rejection" for the portion of the lot that was found to be non-compliant for mislabeling under "labeling defects." Inspection personnel will "Accept" the remainder of the lot.
       3. Although the "rejection" is removed, IID-HQ will ensure that the foreign establishment will remain at the "Intensified" status until 10 consecutive lots of product from the same process category from the same establishment are reported as "Acceptable" for the LVP-TOI and documented through the AIIS. Import inspection personnel will follow the sampling plan outlined in Table A located in IX of this procedure.
11. Lot Disposition
    
    Import inspection personnel must notify import establishment management when a labeling discrepancy is identified. If requested, import establishment management will have one working day to produce documentation in support of the labeling. If supporting documentation is not provided, the importer/broker/applicant may: (1) request to bring the labeling into compliance with the applicable requirements; (2) contact LCPS for a determination as to the acceptability of the label; or, (3) request to continue holding the shipment pending clarification.
    1.  The lot will be rejected if ANY SAMPLE UNIT fails to meet the labeling requirements. Labels may be brought into compliance as stated below.
       1.  Sorting Non-Compliant Containers
          For rejected lots that can be sorted, the importer/applicant or representative will request that the shipment be allowed to be sorted by removing all non-complying containers. Non-compliant containers will be refused entry.
       2. Re-stenciling Labels
          The importer/applicant may correct any labeling deficiency, except shipping marks, by relabeling, stenciling, or obliterating the incorrect markings/labels on all non-complying containers.
       3. Movement to an FSIS Production Establishment
          For rejected lots of carcasses or primal parts not properly marked, the importer/applicant or representative may request to divert this product to an FSIS registered production establishment for further processing. These request will be considered on a case-by-case basis and require approval by the RIFO and Deputy Director of Operations (DDO).
       4. Space on End Panel for “US Inspected and Passed Stamp”
          When there is insufficient space for the application of the mark of inspection, the lot must be placed on HOLD. The lot will remain on HOLD until corrective action is received from the foreign establishment or importer assuring that future shipments will have sufficient space for the mark of inspection. Once written corrective action has been received, the application of the mark to the shipment may proceed. The mark of inspection must be applied in a manner that prevents marking over required labeling information. For example, if the only open space is on the top of each container, the mark will be applied in the top open space of each container. Import establishment management is responsible for breaking down pallets to assure that all containers are marked.
       5. Immediate Containers
          When any randomly selected immediate container label does not comply with the labeling or marking requirements, import inspection personnel will reject the lot. Sorting or the relabeling of immediate containers will be done on a case by case basis with approval from the RIFO and DDO. The importer/applicant must furnish a written plan on how the labels are to be corrected.
       6. Remarking Shipping Marks
          Shipping containers on which the shipping mark is missing, incorrect, partially or completely illegible will be permitted entry provided the containers are marked per the conditions listed in X.B.
       7. Any other corrective action request on labeling deficiencies should be brought to the attention of the RIFO and DDO for approval.
    2.  Procedures for Correcting Shipping Marks
       1. 1. When a portion of a shipping mark is not legible and the identifying characters are identical to the shipping mark of the other containers in the lot, import establishment management will have the option to re-apply (correct) the complete shipping mark by either re-labeling or stenciling the complete shipping mark on all containers in which only part of the shipping mark is legible prior to release of the shipment. This must be done under the supervision of inspection personnel at the official import establishment where the product was presented for reinspection.
       2. Import inspection personnel will have any shipping container which the shipping mark is missing, incorrect, or completely illegible (i.e., no character of the shipping mark is identifiable) sorted and removed from the lot. This product will be rejected and stamped refused entry, unless the importer requests to have the shipping marks re-applied, as permitted below.
          1. An official representing the foreign inspection system will obtain approval to remark the product from the RIFO.
          2. The RIFO will forward the approval to inspection personnel at the import establishment were the remarking will take place.
          3. An official representing the foreign inspection system will re-apply a shipping mark to these containers. If the same shipping mark is applied, the foreign official will provide suitable documentation that certifies the product is covered by the original health certificate. If new shipping marks are applied, the foreign official will provide a new health certificate.
          4. The re-labeling of shipping containers will be done in accordance with FSIS labeling requirements under the supervision of import inspection personnel at an official FSIS import establishment.
          5. The importer or their representative will reimburse the Agency at the specified rate for the cost of the reinspection service furnished for re-labeling. Import inspection personnel will maintain copies of all requests for remarking by filing such requests with the applicable in plant case file.
       3. Shipping containers removed from the lot that are approved to be re-marked by an official representing the foreign inspection service will not be stamped refused entry. Once the shipping mark is applied by the foreign official, the lot must be placed back into the original lot or, if this lot has been completed and released from the import establishment, entered into the AIIS as a new lot. Import inspection personnel will:
          1. Enter the cartons as a partial rejection for labeling into the AIIS, pending remarking by the foreign official. (NOTE: Do not stamp the original foreign health certificate "US Inspected and Passed or Refused Entry"
          2. If the original lot has not been completed and shipped from the import establishment, add the cartons re-marked with the same shipping mark to the original lot and stamp all documents as appropriate.
          3. If any portion of the original lot has been shipped from the import establishment, the importer/broker/agent must modify the import application (FSIS Form 9540-1) by adding the new corrected lot. Enter the new corrected lot into the AIIS using the "Add lot" feature to the original shipment. Obtain an inspection assignment.
          4. Enter in the partial rejection comment section something similar to "shipping marks were re-applied by the foreign official"
          5. Any shipping containers removed from a lot for remarking by a foreign official that is either not approved or is not completed within 45 days will be refused entry. No extensions will be granted.
              
    3. Re-Examination of the Lot
       
       When the add lot is presented for re-inspection it will be considered a new lot and will be reinspected according to the IMOP procedures.
    4. Grade Concerns
       
       Import inspection personnel who have concerns regarding special / nutrition claims, qualifiers, or the use of grading terminology that are not addressed in Enclosure 1 of this procedure should be brought to the attention of the RIFO. If necessary, the RIFO should submit such concerns via e-mail to the IID generic import e-mail address at: (ImportInspection@fsis.usda.gov).