FDA this morning released the long-awaited Proposed Rules for the Foreign Supplier Verification Program (FSVP) and the related Accredited Third-Party Certification Program. These Proposed Rules are part of FDA’s push, begun with the passage of the Food Safety Modernization Act (FSMA), towards a proactive, preventive approach to food safety.
FSVP specifically requires U.S. importers to write and implement a plan where they verify that their foreign supplier and its food complies with the Food, Drug, and Cosmetic Act (FDCA). If a U.S. importer fails to satisfy the requirement, then its entries of food are subject to import refusal.
We’ll be posting more information in the upcoming weeks to more fully explain the Proposed Rules and their implications, but in the meantime there are three main points to take away:
- If importers aren’t FSVP-compliant, they won’t be allowed to import.
- The seafood industry thought FSMA would largely not affect them – it will.
- Foreign Suppliers now have incentive to only do business with importers having good FSV Plans.
FSVP-less importers can’t import: in the press conference this morning, Deputy Commissioner for foods and Veterinary Medicine Michael R. Taylor made it clear that if FDA finds importers not in compliance with FSVP, FDA will “stop them [importers] from importing food.” Previously, FDA issued prohibitions (through import alerts) on the foreign manufacturer – almost never did FDA block the importer.
Seafood, HACCP, and FSVP: the seafood industry needs to watch out; they generally have not paid close attention to FSMA, as they are largely exempted from its requirements. As proposed, FSVP is much stricter than HACCP’s foreign supplier verification requirement. FDA will not allow this incongruity to last and it will not weaken FSVP. Rather, FDA will tighten the requirements for HACCP so that it matches FSVP.
Foreign Suppliers may demand verification: As Michael Taylor said, if an importer is not complying with FSVP, FDA will “stop them [importers] from importing food.” This will not only affect the importer – it affects the foreign manufacturer too. FDA will require their food (which may be entirely compliant) to be exported or destroyed because the U.S. importer failed in its obligations. This can cause serious commercial and regulatory harm to the foreign manufacturer. While the U.S. importer must verify the compliance of the foreign manufacturer, the foreign manufacturer should verify the FSVP compliance of its U.S. importers.