Foreign Supplier Verification Program

Foreign Supplier Verification Program Rule

The Foreign Supplier Verification Program (FSVP) final rule applies to most entities who import food into the United States from abroad, including domestic facilities and food brokers. For each food it imports, an importer would be required to develop, maintain, and follow a Foreign Supplier Verification Program that provides “adequate assurances” that its foreign supplier is producing the food in compliance with processes and procedures that provide “at least the same level of public health protection” as FDA’s standards for preventive controls and produce safety, if either is applicable. The foreign supplier must also demonstrate that it is producing the food in compliance with the adulteration and allergen-labeling requirements of the Food Drug and Cosmetic Act (Sections 402 and 403(w), respectively). To learn more about the FSVP Final Rule go to the GMA Resources section below.

Importers are responsible for actions that include: (i) determining known or reasonably foreseeable hazards with each food imported, (ii) evaluating the risk posed by the food, based on the hazard analysis, and the foreign supplier’s performance, (iii) 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, (iv) conducting supplier verification activities, and (v) conducting corrective actions.   To learn more about the FSVP Final Rule, go to the GMA Resources section below.

Update ( 11/27/2015): On November 27, 2015, three Final Rules were published to the Federal Register: Accredited Third-Party Certification, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

Important Dates: For the Foreign Supplier Verification Program, the earliest compliance date for most entities will be six (6) months after their foreign supplier’s must comply with FSMA regulations or 18 months after the final rule is published, whichever is later. For example, if an importer’s foreign supplier is a very small business that must comply with the Preventive Controls Rule, the foreign supplier would have three (3) years after the Preventive Controls Final Rule is published to comply, and the importer would have six (6) months from that date to comply with FSVP. For Compliance Periods go to the GMA Resources section below.

GMA Resources:

In-Depth Analysis of the Original FSVP Proposed Rule
GMA Comments on the Original FSVP Proposed  Rule
In-Depth Analysis of the Supplemental FSVP Rule
GMA Comments on FSVP for Importers of Food for Humans and Animals
GMA Comments on Economically Motivated Adulteration
FSMA Timeline and Milestones
GMA Reference Sheet for FSMA Compliance Dates
GMA Summary Reference Sheet for FSMA Compliance Dates
Hogan Lovells Memorandum

Links to FSMA Documents:

Full Text of the Original FSVP Proposed Rule
Redlined Supplemental FSVP Rule
Full Text Final FSVP Rule
Full Text of the Supplemental FSVP Rule
Original FSVP PRIA
Supplemental FSVP PRIA

Links to FDA Resources:

FDA’s FSVP Rule page
FSVP Rule Docket

Contact Information: Shannon Cooksey

Disclaimer: The materials on this website are provided for informational purposes only and do not constitute legal advice. GMA does not advise on the application of law to an individual’s or company’s specific circumstances.  Although we go to great lengths to make sure our information is accurate and useful, we recommend you consult a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.