Part 1 of this series discussed the first step of compliance with the Foreign Supplier Verification Program regulations: determining who needed an FSVP. In this blog, we will discuss identifying the key parties in FSVP: the “foreign supplier” and the “importer.”
These terms can provide a false sense of familiarity, as they are commonly used in the trade. However, they are technical terms (terms of art) for FSVP, with their own meaning apart from other context. Thus, it is essential to understand these terms as they relate to the FSVP requirement.
Foreign Supplier
For the FSVP regulation, the “foreign supplier” is “the establishment that manufactures/processes the food . . . or harvests the food that is exported to the United States without further manufacturing/processing by another establishment, except for . . . [an] activity of a de minimis nature.” 21 C.F.R. 1.500
Note that the foreign supplier is the establishment that actually produces the food. This means that food brokers and distributors are not “foreign suppliers” for the FSVP regulation. This definition can create a practical difficulty, as food broker and distributors sometimes seek to keep the actual manufacturer as a trade secret. These food brokers and distributors will need to either disclose their manufacturers or modify their supply chain with the FSVP rule in mind.
In the context of produce/raw agricultural commodities, FDA clarified that the farm which grows the produce, and not a contract harvestor or a packhouse, is the foreign supplier. The Agency justified this appropach by asserting that the farm “produces” the food, while the other entities’ operations are more like holding and packing food.
Importer
The definition of “importer” is one of the more nuanced and complex definitions in the final rule, partially because the definition also includes another defined term, “U.S. owner or consignee.” Unlike Customs, which permits a foreign importer of record, the “importer” under FSVP must be located in the United States.
In the final rule, FDA defined an “importer” as:
- “The U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart.” 21 C.F.R. 1.500
In turn, a “U.S. owner or consignee” is:
- “The person in the United States who, at the time of entry of a food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food.” 21 C.F.R. 1.500
This U.S. locality requirement will cause a regulatory surprise for some companies. Some firms currently rely on foreign importers of record to handle the import clearance process, agreeing to buy the food after Customs clearance, believing that they thereby have no obligations for the importation. However, such firms are actually the “importer” for FSVP and must satisfy that requirement.
Once the importer and foreign supplier are identified, then the actual FSVP process can begin (hazards analysis, risk assessment, verication activities, etc). See below for videos featuring FDAImports.com CEO and Founder Benjamin L. England speak more about FSVP and its impact.
