As mentioned above, in the October 31, 2016, Federal Register, FDA announced the availability of a draft guidance for industry titled "Describing a Hazard that Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety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 This draft guidance explains FDA's current thinking on disclosure statements, which must be made in "documents of the trade" accompanying food, that certain hazards have not been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. This document describes FDA's current thinking and recommendations on how to describe the hazard under each of the four rules and which documents the Agency considers to be "documents of the trade" for the purpose of disclosure statements. Comments are due May 1, 2017.
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