Label Verification of Imported Meat, Poultry, and Egg Products - Revision 2
DO NOT IMPLEMENT THIS DIRECTIVE UNTIL DECEMBER 28, 2020.
I. PURPOSE
This directive provides instructions to inspection program personnel (IPP) for conducting label verification of imported meat, poultry, and egg products. FSIS is reissuing this directive to update regulatory cites for egg products contained in the final rule Egg Products Inspection Regulations (85 FR 68640) and the timeframe in which an applicant may appeal egg products that were refused entry, based on the egg products final rule.
II. CANCELLATION
FSIS Directive 9900.5, Revision 1, Label Verification of Imported Meat, Poultry and Egg Products, 1/24/19
III. BACKGROUND
Foreign establishments exporting to the United States (U.S.) are required to adhere to the labeling requirements in the Federal meat, poultry, and egg product regulations in Title 9 of the Code of Federal Regulations (CFR). IPP verify compliance of imported product presented for reinspection with the labeling regulations by examining the labeling features on shipping and immediate containers, protective coverings, primal parts and carcasses.
IV. LABEL VERIFICATION
A. IPP are to verify that shipping containers, immediate containers, protective coverings, primal parts, and carcasses in every lot presented for reinspection meet FSIS labeling or marking requirements.
B. IPP are to:
- Select the number of sample units (pallets, totes, carcasses) from the presented lots using Table A below;
- Generate random numbers to determine which units in the presented lot are to be identified as the label verification pallets (LVP) or sample units; and
- Based on the number of units (pallets, totes, carcasses) in the presented lot, examine the number of designated sample units (e.g., 15 pallets in presented lot = 2 pallets as designated sample units) after the lot is staged for general condition examination. IPP are to examine the labeling of all cartons on each pallet identified as a sample unit.
C. If any sample cartons need to be opened, to determine label requirements on the interior products or containers (e.g., protective coverings, immediate containers), the sample cartons may need to be moved into the inspection room in the official import inspection establishment. Each shipping container opened to verify the labeling of inner contents must be identified as "USDA OFFICIAL IMPORT SAMPLE.”
V. LABEL VERIFICATION; SHIPMENTS FROM CANADA
A. When verifying the labeling of shipments from Canada that are not assigned any additional types of inspection (TOIs), IPP are to perform label verification on a single shipping container from each lot on the inspection certificate. The label verification is to be performed at the rear of the open truck or trailer backed into the unloading dock at the official import inspection establishment. Import inspection establishment management may rearrange the containers to facilitate the label verification. IPP are to have the establishment unload the conveyance and stage the lot(s), and IPP are to verify the general condition and labeling according to the procedures described in B and C above if any of the following occur:
- IPP observe or suspect any issues with the contents of the conveyance;
- The Label Verification or Certification TOI of the lot(s) is assigned at the intensified or increased level; or
- Additional TOIs (e.g., product exam, laboratory sampling, etc.) are assigned that necessitate unloading and staging of the lot(s) for IPP to select random samples.
B. Shipments from Canada that receive additional TOIs, other than Certification and Label Verification, are to be staged in an approved staging area in the official import inspection establishment where reinspection, including label verification, can occur.
C. When carcasses, sides, or quarters of livestock or ratites are presented for reinspection on a pallet or in a tote labeled as a shipping container, IPP are to verify that the labeling of that pallet or tote meets FSIS requirements.
D. When carcasses are individually labeled with the requirements for shipping containers, IPP are to verify that the labeling of each carcass on that pallet meets FSIS requirements.
VI. VERIFICATION PROCEDURE
A. IPP are to verify that labels are:
- Mechanically printed, stenciled, or stamped directly on the shipping container or on a self-destructive (cannot be removed and placed on another carton) adhesive label affixed to the shipping container. Handwriting is not acceptable on labeling, except for the following: 1) adding the value of random net weights in open net weight statements; or 2) marking checks in pre-printed check-off boxes. Handwriting must be in permanent ink; and
- In the English language. EXCEPTION: Products distributed solely in Puerto Rico may be labeled in Spanish only (9 CFR 317.2(b)).
B. Shipping Containers (meat and poultry) - IPP are to verify that shipping containers (i.e., the outside container) include the:
- Name of the country of origin preceded by "Product of;”
- NOTE: If the name of the country appears in the foreign country’s mark of inspection, or if the shipping container contains fully labeled immediate containers, the phrase "Product of” need not appear (9 CFR 327.14).
- Establishment number assigned by the foreign inspection system;
- Name of the product;
- Name and address of the foreign establishment, distributor, or importer, unless it appears on the labels of the immediate containers, if applicable;
- A complete and legible shipping mark, or other unique identifier that links the product to the foreign inspection certificate. These unique marks are used to link each lot of product to the corresponding lot on a foreign inspection certificate, or other foreign certification documents. FSIS regulations do not prohibit duplicate shipping marks;
- A special handling statement, where applicable, such as "Keep Refrigerated," "Keep Frozen," "Perishable, Keep Under Refrigeration," or such other statement as FSIS’s Labeling and Program Delivery Staff (LPDS) may approve in specific cases (9 CFR 317.2);
- Sufficient space on the main display panel for the USDA mark of import inspection (not applicable for products from Canada) to ensure that the USDA stamp is legible and does not cover any required label features or markings;
- Production dates within the range certified by the foreign inspection system, when the production dates are required by PHIS (e.g., period of ineligibility of country, establishment, product) at the time the application was submitted, or when the lot was received; and
- Weight expressed in terms of avoirdupois weight (e.g., pounds) or liquid (e.g., ounces) measure.
C. Immediate Containers (meat and poultry) - If the shipping containers contain fully labeled immediate containers, IPP are to verify that the immediate containers bear all of the mandatory label features, as required by 9 CFR 317.2 or 381.116.
NOTE: 9 CFR 301.2 defines the immediate container as “the receptacle or other covering in which any product is directly contained or wholly or partially enclosed.” If the product inside the box is not fully labeled, then the outside container (i.e., shipping container) is considered the immediate container and needs to bear all required labeling features of an immediate container including those stated in Section B above. Some features may not be included because of the type of product (e.g., if the product is fully cooked, it does not need safe handling instructions; if the product is not sold at retail and it does not bear a nutrient content claim, then it does not need nutrition labeling).
Specifically, when verifying labeling, IPP are to verify that immediate container labels include the following required features:
- Name of product or descriptive designation of product;
- Ingredients statement, if the product is fabricated from two or more ingredients;
- Foreign establishment number (canned products must comply with 9 CFR 327.14(b)(2));
- Special handling statements, such as "Keep Frozen" or "Keep Refrigerated," if applicable;
- Net quantity of contents, if applicable;
- Manufacturer's or distributor's name and address;
- Nutrition labeling, if applicable;
- Name of the country of origin, preceded by the words "Product of." The phrase "Product of” is required on immediate containers of meat and poultry products; and
- Safe handling instructions for not-ready-to-eat (NRTE) meat and poultry products that have not undergone further processing that would render them ready-to-eat (RTE) and are destined for the consuming public.
NOTE: Exemptions to the safe handling instructions include imported products identified in writing by the applicant as for further processing at an FSIS official establishment (see Section F. below). IPP are to refer to 9 CFR 317. 2(l) and 381.125 for further information on safe handling instructions.
D. Protective Coverings - Note: Products inside shipping containers may be packaged or wrapped in protective coverings without mandatory labeling provided that the shipping containers include all mandatory labeling requirements for immediate containers as referenced in C. above.
If shipping containers contain product wrapped in protective coverings, IPP are to verify that the protective coverings meet the regulatory requirements in 9 CFR 317.1(a). Specifically, IPP are to verify that:
- Processed or prepared product packaged in protective coverings include a statement of limited distribution on the shipping container (e.g., “Packed for Institutional Use,” etc.) and that protective coverings bear no required labeling features; unlabeled product may not be removed from shipping containers for further distribution nor displayed or offered for sale.
- Unprocessed meat cuts packaged in protective coverings bear no required labeling features except that such protective coverings may bear the foreign mark of inspection with country of origin and the establishment number, although this is not required.
- NOTE: Primal parts as defined in 9 CFR 316.9(b) are required to bear the foreign mark of inspection.
- Optional information is allowed on protective coverings, including:
- a. Company brand names;
- b. Trademarks; and
- c. Code numbers.
- When any other mandatory labeling feature appears on a protective covering, IPP are to consider the protective covering an immediate container and verify that all regulatory requirements for labels on immediate containers are met (see paragraph C of this section).
E. Marked Carcasses and Primal Parts - When shipping containers hold carcasses or primal parts, IPP are to verify that the requirements of 9 CFR 316.9(b), 327.14(a), and 327.14(b)(1) are met by observing the carcass or primal part surfaces. The phrase "Product of” is not required on a carcass or primal or sub-primal cut that prominently displays the name of the foreign country within the marking itself. Products required to bear an inspection legend include: red meat carcasses, each primal part of a red meat carcass, beef liver, beef tongue, and beef hearts.
F. Unmarked Carcasses and Primal Parts (Intended Use) - If the shipping conveyance (e.g., truck, or other such container) contains unmarked carcasses or unmarked primal parts, IPP are to allow the movement of the product to an FSIS official establishment for further processing, provided the shipping conveyance or the individual shipping containers are sealed to prevent tampering or substitution of product. Specifically, IPP are to:
- Unless otherwise directed, allow an alternative to the sealing of the shipping conveyance such as tamper-proof sealing of shipping containers of unmarked carcasses or primal parts that bear the official inspection legend on the sealing (e.g. box tape) or wrap;
- Verify that shipping conveyances containing unmarked carcasses or primal parts are resealed after inspection;
- Verify that a company seal is placed on the truck or other conveyance containing carcasses or primal parts, and that the seal number is noted on the shipping documents or invoices;
- Refuse entry to any shipments of unmarked carcasses or primal parts that are not tamper-resistant sealed, or for which destination information is not provided. Fail the Label Verification TOI in PHIS; and
- Retain any shipment of unmarked carcasses or primal parts that arrive without tamper-proof sealing and notify the Front Line Supervisor (FLS) for further instructions.
G. Qualifier, Claims, Grade, or Declaration Concerns - If IPP have concerns regarding special nutrition claims, qualifiers, the use of grading terminology, or other declarations (e.g., “For Cooking Only,” “Not for Grinding”, “Certified Organic by…”), they are to retain the lot, use the Lot Tracking function in PHIS to select, place the lot on hold, and contact the FLS.
NOTE: All labels with claims or certifications must be evaluated by the Office of Policy and Program Development (OPPD), LPDS prior to use. For labeling guidance available to industry see FSIS Labeling Policy Requirements.
H. Egg Products - IPP are to adhere to the following instructions for imported egg products when verifying labeling:
- Shipping Container - IPP are to verify that shipping containers bear the following information (required under 9 CFR 590.955):
- a. Name of the product;
- b. Name of the country of origin;
- NOTE: The name of the country of origin may appear in the inspection mark.
- c. Foreign establishment number where the egg product was processed or packed;
- d. Mark of inspection of the foreign country of origin;
- e. Lot number or production code;
- f. Weight expressed in terms of avoirdupois weight or liquid measure (e.g., lb., oz.); and
- g. Shipping or identification mark identified on the foreign inspection certificate is on the shipping containers.
- Immediate Container and Placards on Tankers - IPP are to verify that the immediate container or any placard bears the following mandatory labeling features, as applicable (required under 9 CFR 590.950):
- a. Name of product;
- b. Name of the country of origin of the product, on packaged products preceded by the words “Product of” and plant number at which the egg product was processed or packaged;
- c. Ingredient statement (for non-single ingredient items);
- d. Manufacturer’s, packer’s, or distributor’s name and address;
- e. Net quantity of content (net weight);
- f. Inspection mark of the country of origin;
- g. Date of production (production code); and
- h. Handling statement such as “Keep Refrigerated” as required under 9 CFR 590.410(a)(1).
NOTE: Egg products from Canada or the Netherlands are not required to bear the official import inspection mark.
VII. LOT DISPOSITIONS
A. IPP that observe imported product that fails to meet labeling regulatory requirements are to fail the Label Verification TOI in PHIS except when missing, incorrect, or completely illegible shipping marks are observed. When IPP observe missing, incorrect, or completely illegible shipping marks, IPP are to fail the Certification TOI. When IPP fail the Label Verification TOI or Certification TOI in PHIS, an automatic refuse entry for the entire lot is triggered. IPP are to go to the Refused Entry screen and click on “Send to Applicant” to notify the applicant of the refusal with an automated e-mail. IPP are to retain the lots that fail the Label Verification TOI or Certification TOI pending an appeal or rectification by the applicant.
NOTE: The applicant may appeal the refused entry (9 CFR 327.24) or request the opportunity to correct the labeling noncompliance in writing to the FLS.
B. The applicant has 45 days for taking specified actions in response to product that has been refused entries as per 9 CFR 327.13(a)(2), 381.202(a)(2), or 590.945(a)(4).
C. IPP are to allow shipping or immediate container labels to be brought into compliance as follows:
- Non-Compliant Containers - For refused entry lots, the importer, applicant, or representative may request that the shipment be sorted to remove all non-complying containers. Non-compliant containers are to be refused entry until corrected. IPP are to retain this product.
- Labels - The importer may correct any label deficiency, except shipping marks, missing foreign government inspection legends, or foreign processing establishment numbers by stenciling or stamping and obliterating the incorrect markings and labels on all non-complying containers. IPP are to verify the correction. IPP are to charge the official import inspection establishment for this reimbursable service as per FSIS Directive 12,600.1, Voluntary Reimbursable Inspection Services.
- NOTE: Hand written labels are not acceptable (9 CFR 317.2).
- Movement to an Official Establishment - For refused entry product that is not properly marked (e.g., missing processing establishment number), or shipments refused entry for label defects on protective coverings, the applicant may request to the District Office (DO) to correct the noncompliance by diverting the product to an official establishment for further processing. If approved, IPP are to seal the conveyance with a USDA seal, complete FSIS Form 7350-1, Request and Notice of Shipment of Sealed Meat/Poultry, and distribute copies of the form as noted on the form. IPP should retain a copy of the form in the case file at the official import inspection establishment.
- Immediate Containers - The sorting or re-labeling of immediate containers is to be approved on a case by case basis by the DO, taking into consideration the importer’s written plan describing how the labels will be corrected.
- IPP are to bring any other requests to correct label noncompliance to the attention of the FLS for approval.
D. Procedures for Correcting Shipping Marks
- When IPP refuse a lot because they observe cartons with partial shipping marks where a portion of a shipping mark is missing or illegible, and the remaining identifying characters are the same as the shipping mark on the other containers in the lot, the importer may rectify the refused entry by sorting the defective cartons from the lot. The importer also has the option to rectify (re-apply or correct) the shipping mark by either re-labeling or by stenciling the complete shipping mark on all containers in which only part of the shipping mark is legible. This may be carried out by the official import inspection establishment without a representative of the foreign government.
- When IPP refuse a lot because there are containers on which the shipping mark is missing, completely illegible, or incorrect, the importer may rectify the refused entry by sorting the defective cartons from the lot. The importer also has the option to rectify (re-apply or correct) the shipping mark by either re-labeling or by stenciling the complete shipping mark on all containers. Do note, however, that for missing, incorrect, or completely illegible shipping marks, rectification must be approved and observed by a representative of the foreign government.
- a. An official representative of the foreign inspection system may seek to obtain approval from the DO to re-certify and/or re-mark the product.
- b. The official representative of the foreign inspection system is to present documentation to support re-certifying the product. This documentation may be a replacement inspection certificate or a letter on the foreign country letterhead.
- c. If the DO decides to permit re-certifying and/or remarking of the product, it is to advise the official representative that they may coordinate with the official import inspection establishment to re-apply the shipping mark to the containers in accordance with FSIS label requirements under the supervision of IPP at the official import inspection establishment. IPP are to charge the official import inspection establishment for this reimbursable service as per FSIS Directive 12,600.1.
E. Procedures for Correcting Shipping Marks when Using Barcodes - FSIS permits official import inspection establishment personnel to apply the shipping mark to shipping units without having an official representative of the foreign inspection system on-site to approve and observe this activity, when FSIS IPP can verify the unique identifier within a barcode on the shipping unit using supporting documentation provided by the foreign country.
NOTE: These procedures apply only to countries that are eligible to use barcodes to verify missing or completely illegible shipping marks.
- When import inspection establishment management indicate they will utilize the barcode on the shipping unit to verify and apply the shipping mark, IPP are to:
- a. Access the Import Inspection Operations (IIO) SharePoint site. If IPP do not have access to this site, they are to send an e-mail to importinspection@fsis.usda.gov to request access. IPP are to include “IIO SharePoint Access” in the e-mail subject line; and
- b. Refer to the “Country Eligibility for Use of Barcodes” document on the IIO SharePoint site to determine whether the country is eligible to utilize barcodes to verify missing or completely illegible shipping marks.
- If the country is not listed on the IIO SharePoint site as eligible for the use of barcodes, IPP are to notify import inspection establishment management that the shipment is not eligible for the use of barcodes to rectify missing or completely illegible shipping marks, and refuse entry of the applicable shipping units.
- If the country is listed on the IIO SharePoint site as eligible for the use of barcodes, IPP are to verify that the foreign producing establishments name and number is on the country list. If the producing establishment number is on the country list, IPP are to review the examples of acceptable documentation available on the SharePoint site and based on these examples ensure that the documentation they have received is acceptable. If the producing establishment number is not on the country list, IPP are to notify import inspection establishment management that the shipment is not eligible for the use of barcodes to rectify missing or completely illegible shipping marks issues, and refuse entry of the applicable shipping units.
- When the foreign country and establishment are eligible for the use of barcodes to rectify missing or completely illegible shipping marks, IPP are to review documentation provided by the import inspection establishment management to verify that the shipping units are part of the lot identified on the foreign inspection certificate. Appropriate documentation would include:
- a. A letter from the CCA attesting to the identification of the shipment; or
- b. A report provided by the exporter that links the barcodes to the lot identified on the foreign inspection certificate.
- IPP are to verify that the barcode for each shipping unit matches the documentation provided. The numbers after the (21) identify the unique shipping unit number.
- IPP are to permit import inspection establishment personnel to apply the shipping mark to the shipping units if the documentation links the barcode to the foreign inspection certificate.
- IPP are to verify whether the shipping units have:
- a. Been identified with the correct shipping mark and release the product; or
- b. Not been identified with the correct shipping mark. IPP are not to release any shipping containers that have not been identified with the correct shipping mark.
NOTE: The IOR may still request to have a representative of the CCA certify and re-mark the product in the event the documentation does not link the barcodes to the foreign inspection certificate.
F. Verification of Corrected Lots - IPP are to observe the remarking. After the remarking is complete, IPP are to reinspect the lot following the procedures set out in Section V of this directive.
- IPP are to complete the disposition of the original lot in PHIS as outlined below:
- a. If a new shipping mark is applied, or if the original shipping mark is re-applied to the noncompliant cartons from the original lot (and the remainder of the lot is inspected and passed and released into commerce):
- i. Access the application and lot in PHIS and unlock the original application;
- ii. In PHIS, copy the original lot from the original application, thereby creating a new lot for the remarked product with the original application. Adjust the shipping mark, number of containers, and net weight, as applicable. Save and submit the application;
- iii. Access the application and new lot in PHIS. From the Lot Manager screen, receive the lot; and
- iv. Access the application and the original lot in PHIS from the Lot Manager screen, select Refused Entry, and complete disposition (e.g., re-marked with new shipping mark) of the refused entry product.
- a. If a new shipping mark is applied, or if the original shipping mark is re-applied to the noncompliant cartons from the original lot (and the remainder of the lot is inspected and passed and released into commerce):
b. If the original shipping mark is applied (shipping mark on original inspection certificate), and the entire lot or remainder of the lot is held pending the re-application of the shipping mark:
- i. Access the application and lot in PHIS. From the Lot Manager screen, select Refused Entry and Rectification (e.g., re-marked with original shipping mark) of the refused entry product; and
- ii. Perform any remaining reinspections on the lot.
VIII. HANDLING OF REFUSED ENTRY
IPP are to refer to FSIS Directive 9900.8, Meat, Poultry, and Egg Products Refused Entry Into The United States, for instructions on managing refused entry product.
IX. QUESTIONS
Refer questions regarding this directive to the OPPD Import and Export Policy Development Staff through askFSIS or by telephone at 202-690-4354.