Annex L: Guideline for Food Safety and Inspection Service (FSIS) port of entry inspection requirements

1. Introduction

All imported shipments of meat products must be presented to Food Safety and Inspection Service (FSIS) for inspection. FSIS import inspection occurs after the product has met U.S. Customs and Border Protection (CBP) and USDA-Animal and Plant Health Inspection Service (APHIS) requirements at the U.S. Port of Entry (for example conditional release). CBP's release of the shipment at the U.S. Port of Entry allows the shipment to transfer to the designated FSIS official import inspection establishment. It does not mean that FSIS import inspection requirements have been met.

The importer (person primarily liable for the payment of any duties on the merchandise, or an authorized agent acting on the importer's behalf, such as a broker (19 CFR 101.1)) must apply for FSIS inspection of imported product (9 CFR 327.5, 381.198, and 590.920). Importers (foe example the applicant) must either the paper FSIS Form 9540-1 Import Inspection Application to the FSIS inspection personnel in the designated official import inspection establishment; or the electronic application data (Partner Government Agency (PGA) Message Set) into the U.S.

Importers must submit the inspection application as far as possible in advance of the anticipated arrival of each consignment, but no later than when entry is filed with CBP (9 CFR 327.5(b), 381.198(b), and 590.920(b)). Importers who submit inspection application data electronically using the PGA Message Set automatically meet the prior notification requirement. The prior notification requirement is particularly important for shipments that cross land borders (U.S.-Canada and U.S. –Mexico), because of the relative speed with which those shipments enter the United States, compared to shipments that enter the country on ocean vessels or by air. For all shipments, including those from Canada and Mexico, it is essential that sufficient advance notice occur to ensure data entry can be completed in advance of the shipment arriving at the official import inspection establishment to avoid delays at the official import inspection establishment. Import inspection applications must be complete, including the Customs entry number. Further guidance on the PHIS Import Component can be found in the following industry Q&A.

Refer also to FSIS Guidance for Importing Meat, Poultry, and Egg Products into the United States (PDF – 1,149 kb), FSIS Directives 9900.1 (PDF – 73 kb) and 9900.2 (PDF – 386 kb) for more information.

2. Failure to Present (FTP)

Any shipment of meat, poultry, or egg product that has entered commerce without FSIS import inspection violates the FMIA; the PPIA; or the EPIA, as well as the associated implementing regulations (9 CFR 327.6; 381.199; 590.925). Meat, poultry, and egg products from outside the U.S. are considered "in-commerce" when they are off-loaded at a location other than the official import inspection establishment or the official egg processing establishment designated on the import inspection application. FSIS considers such product to be a Failure to Present (FTP), and therefore ineligible for FSIS inspection. When a product has been identified as a FTP, FSIS will request, through CBP, a redelivery of the shipment and appropriate penalties.

FTP product still in the original shipping containers may either be destroyed or returned to the country of origin. If any imported product identified as FTP has been removed from the original cartons or further processed, FSIS will initiate a regulatory control action on the product, including any further processed product that contains the FTP product, to ensure appropriate disposition (for example, destruction). FSIS will likely request that the importer recall the FTP product.

3. Products categorization

To help foreign exporters and governments accurately identify eligible meat, poultry, and egg products intended for export to the United States, FSIS has published an updated Product Categorization guide on the Agency's website (PDF – 184 kb)

The guide now aligns more closely with product categorization in PHIS and includes all species that are now under FSIS jurisdiction.

4. Product lot grouping and certification

FSIS requires product to be presented for reinspection in lots certified on the official inspection certificate. PHIS assigns reinspection tasks based on the lots included on the certificate/eCert. The lots on the certificate/eCert must align with those on the FSIS 9540-1 Import Inspection Application or PGA Message Set, and cannot be changed at import reinspection. Therefore, it is critical that the importer (or agent) correlates the lotting and certification of the product with the foreign exporter before the foreign government certifies the shipment. When the lots on the inspection certificate do not match the lots on the import application, FSIS requires a replacement inspection certificate to continue reinspection of a shipment. The importer (or agent) must resolve any discrepancies between the import application and the official inspection certificate before FSIS reinspection takes place. PHIS allows this process to take place electronically between the importer (or agent) and the FSIS import inspector.

Lot groupings are based on like product by species, process category, product category and product group. The FSIS Product Categorization Chart (PDF – 184 kb) provides product descriptions to determine lot grouping on the official inspection certificate. When a shipment includes multiple lots of like product with the same shipping mark, additional information must be provided (for example production dates) to identify the lots. Refer to Annex L-3 for more details.

5. Placement of containers on trucks

Shipping containers at the rear of the truck must be loaded on the truck so that the labelling features face the rear of the truck allowing the USDA-FSIS inspector to conduct the required verification.

6. FSIS sampling process

FSIS reinspection sampling is allocated by country, process category, product category, product group and in some instances, species. Each imported product shipment is to be identified by the foreign exporting establishment with a unique shipping mark or identification mark that is entered into PHIS for the initial identification and subsequent tracking of the product while in U.S. commerce distribution channels. When a lot of imported product is selected for reinspection, several types of inspection (TOI) may be assigned and performed by FSIS import inspection personnel. These include a physical examination of the product for visible defects and an examination of container condition.

At set intervals, FSIS also collects and analyzes samples for pathogens, food chemistry, and drug and chemical residues. There are three levels of reinspection (LOR) relative to sampling: Normal LOR is randomly selected lots based on the annual sampling plan; Increased LOR is targeted based on a FSIS management decision; and Intensified LOR is automatically generated by PHIS after a lot fails a TOI.

If a shipment fails reinspection, the result is recorded in PHIS. Thereafter, PHIS will automatically generate an intensified rate of reinspection. In the case of failures the next 15 consecutive lots (and 15 times the weight of the failed lot) are selected for repeat analysis. Products that fail reinspection are refused entry into the United States. If the IOR wants to appeal a failed TOI, they are to go through the appropriate chain of command within the Office of Field Operations.

Products that pass reinspection are allowed to enter U.S. commerce. Under U.S. meat, poultry, and egg products inspection laws, reinspected and passed imported articles are, upon entry into the United States, deemed and treated as domestic articles in commerce.

7. Laboratory testing

When FSIS schedules a laboratory TOI of selected products for specific adulterants, the selected product shipment must be held pending acceptable results (Test and Hold on Shipments).

The test and hold policy above applies to imported shipments of:

1. Non-intact raw beef product or intact raw beef product intended for non-intact use that is tested for Escherichia coli O157:H7 (E. coli O157:H7) and other shiga-toxin producing E. coli (STEC) that FSIS considers to be adulterants
2. Ready-to-eat products tested for Listeria monocytogenes or Salmonella
3. Livestock carcasses and meat products tested for residues and

The test and hold policy above does not apply to imported shipments of:

1. Raw meat or poultry products tested for Salmonella or other pathogens that FSIS has not designated as adulterants in those products or
2. Poultry carcasses or raw poultry parts sampled for residues

The importer, or the importer's agent, is responsible for controlling the product that is on hold. The sampled lot may move off-site, however, the held shipment must be controlled (for example, company seals) and not enter into commerce until acceptable results are received and the FSIS reinspection is completed. The sampled lot may move off-site if the laboratory TOI is assigned at the Normal level of reinspection (LOR). When the laboratory TOI is assigned at the Increased or Intensified LOR, the lot is ineligible to move from the official import inspection establishment until acceptable laboratory sample results are reported. The IOR is responsible for ensuring that the product does not move into commerce prior to the receipt of acceptable laboratory results and the completion of the product reinspection by FSIS.

If the laboratory analysis results show that the product is not in compliance, shipments on hold must be returned to the official import inspection establishment, have the marks of inspection obliterated, and will be stamped "United States Refused Entry." The IOR and the import establishment management can receive laboratory results electronically directly from the FSIS laboratory by providing an e-mail address on the FSIS import inspection application. FSIS has prepared a compliance guideline for the test and hold requirements: FSIS Compliance Guideline for Controlling Meat and Poultry Products Pending FSIS Test Results (PDF – 167 kb).

8. U.S. refused entry process

Meat, poultry, and egg products that do not comply with U.S requirements are not allowed by FSIS to enter U.S. commerce and are identified with a "United States Refused Entry" stamp or tag. When FSIS refuses entry, FSIS sends a notification from PHIS to the applicant by e-mail, utilizing the email address provided on the import inspection application. Product that is securely held at a location other than the official import establishment, pending lab results, must be returned to the official import establishment if the product is Refused Entry. Within 45 days for meat and poultry and 30 days for egg products, the IOR must provide disposition of the refused entry product 9 CFR 327.13(a)(2), 381.202(a)(2), or 590.945(a)). Disposition options for refused entry products include: rectification (for example misbranded brought into compliance within the product-specific time frames listed above); exportation (return) to originating country or third country; landfill; rendering; incineration; denaturing the product not for human food; or conversion of product to animal food with prior Food and Drug Administration (FDA) approval. The IOR is to notify FSIS in writing if he/she wishes to bring refused entry product into compliance, or appeal the refusal. FSIS provides for extensions to the timeframes for product to be re-exported, which may be requested by the IOR when extreme circumstances warrant it (for example, a dock workers strike or unforeseeable vessel delay).