Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety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) details the agency’s current thinking related to “disclosure 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 final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.
“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,” according to an FDA release.
The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).