The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety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 is intended for any entity that is subject to certain provisions (in part 117, part 507, the produce safety regulation, or the FSVP regulation) that require a disclosure statement, in documents accompanying food, that certain hazards have not been controlled by that entity.

The resource covers the four following FSMA rules:

• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

Using this guidance the FDA aims 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 the statements accompanying the food. Download the full draft guidance here. :

For More Information

• Federal Register Notice
• Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety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
• FDA Food Safety Modernization Act