FDA Clarifies Owners and Purchasers as Responsible for Verification in Final FSVP Rule

importerA big win for IWLA! The U.S. Food and Drug Administration (FDA) published the final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. 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 final rule favorably addresses IWLA’s concern that a 3PL could be considered an “agent” or “consignee,” and thus become responsible to verify foreign suppliers. IWLA raised this in written comments on the proposed rule in a 2014 conference call with FDA.

Here are excerpts from the final rule:

“For the purposes of FSVP, 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 of consignee at the time of entry, as confirmed in a signed statement of consent.”

“We [FDA]are defining ‘U.S. owner or consignee’ to mean 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.”

“We [FDA] agree that a person should not be required to serve as the U.S. agent or representative of a foreign owner or consignee unless the person has agreed to serve in this capacity. …we therefore are adding a clarification to the definition of ‘importer’ stating that when the foreign owner or consignee of the article must designate a U.S. agent or representative (when there is no U.S. owner or consignee) for the purposes of the definition of ‘importer,’ the U.S. agent or representative’s role should be confirmed in a signed statement of consent. The signed statement of consent must confirm that the U.S. agent or representative agrees to serve as the importer under the FSVP regulation.”

“The effect of our change to the definition of ‘importer,’ in conjunction with the new definition of ‘U.S. owner or consignee,’ likely will result in different entities serving as the FSVP importer in some circumstances than those who might have served as the importer under the proposed definition. For instance, in the case of a Canadian company that ships a food product to a Montana warehouse and for which delivery is made to the Montana facility in anticipation of possible orders from customers in the United States, it is possible, under the proposed rule, that the warehouse would have been the FSVP ‘importer’ because the food might be considered to be consigned to the warehouse at the time of entry and no one in the United States at the time of entry either owned or had purchased the food. Under the final rule, however, the warehouse would not necessarily be the FSVP importer. Because there is no person in the United States at the time of entry who owns the food, purchased the food, or promised to purchase the food, there is no  ‘U.S. owner or consignee.’ Therefore, the FSVP ‘importer’ would have to be a properly designated U.S. agent or representative.”

This is an enormous victory for IWLA. The association stepped in at the right time to raise concerns and add further clarification on the responsibilities of third-party warehouse providers. Thank you to everyone who contributed to our comments and participated in this effort.

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