FSMA204 Rule

Requirements for Additional Traceability Records for Certain Foods

“Extended 30 Months”

FSMA204 Rule? FTL? KDE? A lot of talk is going on in the food industry about the latest regulations from the U.S. Food and Drug Administration (U.S. FDA)—and it can be a lot to digest.

With a full plate of requirements, here is some information to snack on:

Signed into law in 2011, the Food Safety Modernization Act (FSMA) aims to strengthen the food safety system to protect public health.
Section 204(d), also known as FSMA204 Rule or the U.S. FDA Food Traceability Final Rule, went into effect in January 2023 and establishes the framework for end-to-end traceability throughout the food industry by requiring companies to maintain and provide specific information, also known as records.
The rule outlines specific Key Data Elements (KDEs) that describe Critical Tracking Events (CTEs), or steps in the supply chain, which need to be recorded.
If you manufacture, process, pack, or hold any of the foods on the Food Traceability List (FTL), you are required to keep and sometimes share these records.