FDA Update: Guidance on Four Rules Implementing the FDA Food Safety Modernization Act

The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety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:

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 Download the full draft guidance here:

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About Anastasia Sonneman

Anastasia Sonneman serves as a Communications Specialist at NACCHO. Her work includes promoting local health departments' best practices, as well as partner tools and resources, in environmental health, health and disability, and preparedness through NACCHO's communications channels, storytelling, and outreach to various audiences.

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