Foreign Supplier Verification Program

What is Foreign Supplier Verification Program (FSVP)

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Foreign Supplier Verification Program (FSVP)

The Food and Drug Administration (FDA) oversees the safety of most of the human and animal food consumed in the United States. For the safety of imported food, FDA assures that food imported from abroad is held to the same food safety requirements and standards as food produced domestically. 

The FDA Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Under the Foreign Supplier Verification Programs (FSVP) regulation, a U.S.-based importer is now required, among other things, to conduct a hazard analysis – an evaluation of risk of the food and foreign supplier – and to conduct verification activities based on the hazard analysis.

This new authority augments the agency’s authority in the seafood and juice hazard analysis and critical control point (HACCP) rules, which also require importers to verify their suppliers. In addition, the FSVP rule complements supply chain controls required as preventive controls for some foods. Through inspection of importers, domestic producers, and foreign suppliers, FDA will promote compliance with foreign supplier verification programs as well as supply chain requirements and will gather additional information to prevent unsafe food from entering the U.S. market.

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In-Depth Coverage: Importing Food Products 

The regulation applies to U.S. importers of food. However, importers may request information from their foreign suppliers or others to meet their FSVP requirements.

Standard FSVP requirements include, but are not limited to,

  • conducting hazard analyses for imported food,
  • evaluating the food and the foreign supplier,
  • determining and performing supplier verification activities,
  • taking corrective actions (when necessary),
  • ensuring importer identification at entry, and
  • maintaining records.

The FSVP importer of a food might choose to rely on others to conduct certain FSVP activities, provided the importer reviews and assesses the results of these activities. For example, an importer may rely on a hazard analysis of a food conducted by the foreign supplier, and an importer might rely on the results of an independent third-party audit of the supplier that the supplier has requested.  Depending on what verification activities the importer conducts, the importer might request information from the foreign supplier, such as results of audits or copies of relevant food safety records, so that it can meet its verification requirements.

FSMA: Final Rules for FSVP and Third Party Auditors

In-Depth Coverage: Country of Origin

Who is the Importer under FSVP?

For the purposes of FSVP, the definition of the term “importer” is the “U.S. owner or consignee” of an article of food offered for import into the U.S. This is the person in the United States who, at the time of entry of an article of food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.

Is the “importer” under the FSVP rule the same as the “importer of record” recognized by U.S. Customs and Border Protection for import entry?

The importer of record (as defined by CBP) may be the same as the importer under FSVP, but is not necessarily. The FSVP Importer performs certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. In contrast, the CBP importer of record of a food might be an express consignment operator with little to no knowledge of the safety regulations applicable to the products for which they obtain clearance from CBP.

What do I need to do to verify my foreign supplier is following the FSVP rule?

Importers covered by FSVP must have a program in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls requirements for human and animal food under section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the produce safety requirements under section 419 of the FD&C Act if applicable, and the implementing regulations, and to ensure that the food is not adulterated and is not misbranded with respect to allergen labeling.

Standard FSVP requirements include determining known or reasonably foreseeable hazards with each food; evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier's performance; using that evaluation of the risk posed by an imported food and the supplier's performance to approve suppliers and determine appropriate supplier verification activities; conducting supplier verification activities; and conducting corrective actions, as appropriate. Modified requirements may apply in some circumstances.

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Are foods that are subject to USDA regulation exempt from FSVP?

The FSVP regulation does not apply to certain meat, poultry, and egg products that at the time of U.S. entry are subject to USDA regulation, as follows:

1)  Meat food products that, at the time of importation, are subject to the requirements of USDA under the Federal Meat Inspection Act (FMIA).

The FMIA regulates the inspection of the following species: cattle, sheep, swine, goats, horses, mules or other equines, including their carcasses and parts. In addition, under the FMIA, the USDA regulates fish of the order Siluriformes and products derived from these fish.

Food from other animals (e.g., bison, rabbits, game animals, and all members of the deer family including elk (wapiti) and moose) is not subject to the requirements of the FMIA at the time of importation and therefore would be subject to FSVP.

In addition, products with 3 percent or less raw meat; less than 2 percent cooked meat or other portions of the carcass; or less than 30 percent fat, tallow or meat extract, alone or in combination; and closed-face sandwiches are not subject to the requirements of the FMIA at the time of importation and therefore would be subject to FSVP.

In-Depth Coverage: USDA-Regulated Products

2)  Poultry products that at the time of importation are subject to the requirements of the USDA under the Poultry Products Inspection Act (PPIA).

The PPIA defines the term poultry as any domesticated bird. USDA has interpreted this to include domestic chickens, turkeys, ducks, geese and guineas, ratites and squab. Products containing either less than 2 percent cooked poultry meat; or less than 10 percent cooked poultry skins, giblets, fat and poultry meat (limited to less than 2 percent); and closed-face sandwiches are not subject to the requirements of the PPIA at the time of importation and therefore would be subject to FSVP. In addition, food from all non-specified birds, including wild turkeys, wild ducks, and wild geese, is not subject to the requirements of the PPIA at the time of importation.

3)  Egg products that at the time of importation are subject to the requirements of the USDA under the Egg Products Inspection Act (EPIA).

Egg products are made from the shell eggs of domesticated chicken, turkey, duck, goose or guinea. USDA defines “egg product” to include dried, frozen, or liquid eggs, with or without added ingredients, but mentions many exceptions. Note that egg products do not include shell eggs.

Also, egg products do not include, among other foods: egg substitutes, cooked egg products, freeze-dried products, imitation egg products, dietary foods, dried no-bake custard mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, sandwiches containing eggs or egg products, and balut and other similar ethnic delicacies.

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