On November 13, 2015, the United States Food and Drug Administration (FDA) finalized three new rules designed to increase foods safety in the wake of recent food-borne illness outbreaks. Significantly, as part of this expansion of the Food Safety Modernization Act (FSMA), the FDA has created new obligations for food importers to verify that foreign suppliers are complying with U.S. safety standards.

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The Foreign Supplier Verification Programs (FSVP) for Importers of Food for Human and Animals sets forth substantial obligations for food importers to help minimize risks to food safety throughout their supply chain. Under the FSVP, food importers are required to develop and maintain procedures to ensure that their foreign producers are abiding by the same levels of public health standards which would be applicable in the United States.  To comply with the FSVP, importers must maintain detailed records of thier supply chain protocols and preventative controls in addition to conducting audits and evaluations of each of their foreign producers.

In addition, importers must also evaluate any known or foreseeable hazards associated with specific foods they import.  This ‘hazard analysis’ is designed to evaluate all of the potential areas where food-borne illness may arise; from the harvesting of raw materials and food formulation, to transportation, storage, and final distribution.  Importers may rely on third-party auditors to evaluate the foreseeable risks in their supply chain, however, the importer must review and assess any evaluations from foreign producers or third-party auditors.

The FSVP is set to take effect in 18 months. The first step for U.S. importers is evaluate the supply chain policies they have in place and to develop and test additional ‘risk analysis’ protocols.  The FDA is in the process of creating additional guidance for importers, but knowledgeable counsel will likely be an invaluable resource when navigating these new and potentially onerous provisions of the FSMA.