Compliance dates approaching: Food Safety Modernization Act (FSMA) requirements for Foreign Supplier Verification Programs (FSVP) for importers of food

April 11, 2017 By


Service(s) related to this article:  FSMA Consulting Services

Food Safety Modernization Act (FSMA) Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals – Compliance Dates Fast Approaching

A key initiative under the Food Safety Modernization Act (FSMA) is the establishment of Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. The FDA FSMA Final Rule on FSVP was published November 27, 2015, and became effective January 26, 2016. Compliance dates for some businesses are fast approaching, beginning as soon as May 30, 2017.

Who is covered by the rule?

Importers of food into the United States are covered. FSVP defines an importer as the U.S. owner or consignee of the food, or when there is no U.S. owner or consignee, the U.S. agency or representative of the foreign owner of the consignee at the time of entry.

The final rule requires that importers perform 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. These include:

Determining known or reasonably foreseeable hazards with each food, evaluating the risk posed by a food, using that evaluation of the risk to approve suppliers, conducting supplier verification activities, and conducting corrective actions.

Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance.

Importers are required to develop, maintain and follow a Foreign Supplier Verification Program (FSVP) for each food brought into the United States, and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.

Under the FSMA requirements for FSVP, the evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance.

Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements.

Compliance Dates

The compliance dates for importers subject to the Foreign Supplier Verification Program (FSVP) rule differ according to a number of considerations, including the size of the foreign supplier, the nature of the importer, and whether the foreign supplier must meet the requirements of the “Preventive Controls (PC)” rules (the final rules for GMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food / Food for Animals).

The date by which importers must comply with the FSVP regulations is the latest of the following dates:

  • 18 months after publication of the final rule (i.e. May 27, 2017);
  • For food from a supplier that is subject to the PC or produce safety rules, six months after the foreign supplier is required to meet those regulations;
  • For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions.

For those importers whose suppliers are in the last two categories above, the compliance dates range from March 17, 2019 to July 27, 2020. Note that for business suppliers that do not have qualified exemptions under these categories, the compliance date is May 30, 2017.

In summary, the Food Safety Modernization Act (FSMA) Final Rule for Foreign Supplier Verification Programs (FSVP) carries a number of requirements that must be met by importers of food. Importers must be aware of the compliance dates associated with this key aspect of food safety in the U.S.

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