FDA Issues Draft Guidance on FSMA Downstream Customer Disclosure Statements

The Food and Drug Administration issued draft guidance (here) on how to comply with Food Safety Modernization Act regulations that allow food facilities and importers to rely on downstream customers to control food safety hazards. Included under FSMA regulations on produce safety, preventive controls for human and animal food and the Foreign Supplier Verification Program, the regulations require a disclosure statement, in documents accompanying food, that certain hazards have not been controlled by the food facility or importer. According to the draft guidance, the statement may be provided using a “wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read,” though it is “not sufficient to reference a website in a document of the trade without including the disclosure statement, itself, in the document of the trade,” FDA said. In FSVP disclosure statements, importers may identify biological hazards using general terms (i.e., not describing the specific microbe), but chemical and physical hazards must be described specifically, the draft guidance said. Comments on the draft are due May 1, FDA said (here).