June Edition

  • U.S. FDA Foreign Supplier Verification Program now in force

U.S. FDA Foreign Supplier Verification Program now in force

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The FSVP which became effective on 27th May is a central feature of the U.S Food Safety Modernization Act (FSMA). It is intended to provide a flexible, risk-based system to verify foreign suppliers and the safety of the food they produce. Key elements of the scheme involve:

  • the clear identification of each FSVP Importer of food products supplied by foreign producers;
  • the responsibility of each such importer for the establishment of foreign supplier verification procedures to ensure that their overseas suppliers always use safe processes and procedures and that the food they supply is not adulterated or misbranded;
  • the correct identification of each FSVP Importer on all ACE (Automated Commercial Environment) documents
  • the obligation of each food importer to determine if he/she is the duly recognised FSVP Importer (and, if not, who is) so that the task of properly verifying all foreign suppliers can begin.

Who is a FSVP Importer?

The FSVP Importer must be a U.S. owner or consignee of the imported goods with a direct financial interest in the food product. The FDA definition of such an owner/consignee is the person who, at the time of entry, owns, has purchased, or has agreed in writing to purchase the food.

If there is no U.S. owner or consignee at the time of entry, the foreign supplier of the food must appoint a U.S. FSVP agent who will be responsible for ensuring that all required supplier verification activities are carried out for each food product imported. In all such cases the appointment of such an agent must be confirmed in a formal written document for submission to U.S. customs - duly signed by the agent - to confirm his/her consent. NB the FSVP agent should not be confused with the agent required for food facility registration.

FSVP importers are also required to verify that their foreign suppliers produce food in a manner that meets the same level of public health protection as the Preventive Controls for Human and Animal Food Rules (21 CFR Part 117, Part 507) and Produce Safety Rule (21 CFR Part 113); and guarantee that such food is unadulterated and is also properly labelled for allergens.

Please note that FedEx can in no circumstances act as the FSVP agent for any of our customers.

Exceptions to the new regulations

Food imported for personal consumption or for research and evaluation, various alcoholic beverages and juices and certain other food products are exempt from the above controls. Exceptions also exist for importers with low sales income over a given time frame, certain smaller food suppliers, and imports from countries/territories with similar food safety systems to those used in the U.S., plus several further categories.

For full details of all such exceptions click here.

Compliance Dates

There is a range of dates by which importers are required to meet the new FSVP regulations. These are based on the size of the receiving facility, the nature of the importer, and the date by when the receiving facility’s supplier is required to comply with the new FSMA regulations.

The earliest of these dates was 30th May 2017, while the latest – for “very small businesses” as defined in 21 CFR 112.3 – is 27th July 2020. For further information on compliance dates click here.

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