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FDA Releases Guidance for Industry Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act The U.S. Food and Drug Administration is announcing today the release of a Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA). This guidance explains our current thinking on statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four FSMA rules. These provisions are found in the regulations for preventive controls for human food (PCHF), preventive controls for animal food (PCAF), produce safety, and foreign supplier verification programs (FSVP). This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food. Food Safety Modernization Act and Animal Feed
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