According to NGFA, the U.S. Food and Drug Administration (FDA) on Jan. 10 issued final guidance for the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals rule. The FSVP regulations were mandated by the Food Safety Modernization Act (FSMA) and require that importers of human and animal foods verify the foods are produced in compliance with the hazard analysis and risk-based preventive controls requirements established under other FSMA-related rules, are not adulterated, and are not misbranded.
The final guidance provides information to importers of human and animal food about how they can comply with the FSVP regulation. It includes recommendations on the requirements to analyze the hazards in food; evaluate a potential foreign supplier’s performance and the risk posed by the food; and determine and conduct appropriate foreign supplier verification activities.
Significant to the grain and feed industry, FDA previously issued a document in January 2018 indicating that the agency intends to exercise enforcement discretion in regard to application of the FSVP rule to certain importers of raw agricultural commodities that FDA classifies as “grain.”
This enforcement discretion is still in effect and applies to those importers of “grain” that: 1) are solely engaged in the storage of grain intended for further distribution or processing; or 2) do not take physical possession of the grain they import, but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing. FDA’s use of enforcement discretion in this respect means the agency does not intend to enforce the FSVP requirements for importers of grain meeting either of the two specified conditions.
FDA’s new guidance finalizes a draft guidance issued in 2018. In response to comments received to the draft guidance, including those made by NGFA, changes were made to the final guidance, including providing additional clarification regarding to what food the FSVP regulation applies; what information must be included in the FSVP; and who must develop and perform FSVP activities.