Foreign Supplier Verification

Responsible Parties
The proposed rule’s definitions of “importer” and “foreign supplier” create uncertainties about obligations under FSVP. While an importer is required to conduct verifications of the supplier’s activities, the proposed rule defines the importer as the U.S. person who purchased the food for importation, or to whom it is consigned at the time of entry, or the U.S. agent of the foreign owner if it has not been sold or consigned at the time of entry.

The FSVP importer may not always be the importer of record for Customs purposes. This is important because the FSVP importer bears FSMA obligations and may be required to obtain and use a Dun & Bradstreet Data Universal Numbering System (“DUNS”) number in its entries, while the importer of record bears many Customs responsibilities and will use its importer identification number. If these two “importers” of a food shipment are not the same, the Customs and FDA compliance responsibilities may be difficult to separate.

Second, the proposed rule defines a foreign supplier as the manufacturer or harvester of the food. Exporters of fresh produce may be handlers or aggregators rather than harvesters, in which case the importer may not be able to verify that the actual harvesters have complied with the Produce Safety rule. Comments on the proposed rule have suggested that handlers or aggregators be included within the definition of “supplier” under FSVP, so the importer is required to verify that the handler or aggregator is in compliance with the Produce Safety or Preventive Controls rule, and has procedures to verify that harvesters are also in compliance.

Importer Assurances and Verification Activities
Importer FSVPs must be “adequate to provide assurances that each foreign supplier to the importer produces the imported food employing processes and procedures, including risk-based reasonably appropriate preventive controls, equivalent in preventing adulteration and reducing hazards” as required by FSMA’s Produce Safety and Preventive Controls rules.

It will be the importer’s responsibility to “verify” the foreign supplier meets its responsibilities under either the Produce Safety rule or the Preventive Controls rule (or both) of FSMA. The FDA may also require importers to perform “verification activities,” including “monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive controls plan of the foreign supplier, and periodically sampling shipments.”

The proposed FSVP rule provides two options for importer compliance, depending on the type of food product, category of importer, the nature of the identified hazard and who controls the risk. The final FSVP rule will determine the activities under the common framework that importers must undertake.

Recommendations for Compliance with the FSVP Common Framework
Many advisors to food importers recommended immediate development of procedures to comply with FSVP. While getting a head start on compliance issues can be a benefit, without knowing the requirements of the final rule, importers risk missing the final target or overextending their efforts beyond what is actually required. The proposed FSVP rule provides sufficient guidance in its common framework to assist food importers in developing compliance programs that will likely meet the final FSVP requirements.