On October 31, 2016, FDA announced the availability of a draft guidance for industry titled "Describing a Hazard that Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry." This draft guidance explains FDA's current thinking on statements made by an entity in documents accompanying food, which disclose that certain hazards have not been controlled by that entity as required by certain provisions in the four final rules—Preventive Controls for Human Food, Preventive Controls for Food for Animals, Produce Safety Regulation, and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. FDA provides that a disclosure statement would be required mostly for biological hazards, for which general terms may be used (e.g., "microbial pathogens" rather than "Salmonella"). However, a manufacturing/processing facility that chooses not to control chemical or physical hazards, and relies on its customers to do so, would have to indentify such hazards using a specific term, such as "mycotoxins," "aflatoxin," or "stones." These disclosures must be made in "documents of the trade": documents accompanying 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." FDA does not consider it sufficient to reference a website in a document of the trade without including the disclosure statement itself. Finally, FDA does not recommend documents such as contractual agreements, letters of guarantee, specifications, or terms and conditions to be used as documents of the trade. Comments are due May 1, 2017.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.