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On November 16, 2015, FDA published the FSMA final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals and the first compliance dates began May 30. 2017.

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.

The FSVP applies only to importers of food products in the United States.  By federal definition, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.

For more information, see the Am I Subject to FSVP flow diagram.

Importers of the following categories of food products do not have to comply with the FSVP rule:

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

Read more on Compliance Dates for the FSVP Final Rule and Compliance Date Extensions and Clarifications for FSMA Final Rules.

FSVP is a program that importers covered by the rule must have 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 or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

The specific responsibilities of importers with respect to food safety include:

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 or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.

Importers are required to develop, maintain, and follow an 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. Similarly, if the importer obtains many different foods, from a single supplier, a separate FSVP would be required for each food.

Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if:

The FSVP rule requires importers to provide the name, email address, and unique facility identifier (UFI) for each line entry of food product offered for importation into the United States.

DUNS numbers, assigned and managed by DUN & Bradstreet, are available free of charge to importers by visiting FDAdunslookup.com.

In certain cases, importers need not comply with all the FSVP requirements. The criteria for modified FSVP requirements are listed below.


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