Guide: The Finalized FDA Food Traceability Rule

About the Food Traceability Guide

On November 7, 2022, the FDA published the much-anticipated final version of the Food Traceability Rule (or FSMA 204). Over 10 years in the making, this rule impacts many food industry segments and will allow regulators to identify the source of foodborne illness outbreaks more quickly.

The records required in the finalized Food Traceability Rule will vary depending on the product and processes being used, and it will include Critical Tracking Events (CTEs) and Key Data Elements (KTEs) that can be provided to the FDA or regulators within 24 hours in the event of an investigation or recall.

Previous Traceability Rule guidance lacked the level of granularity needed to track food items back to a specific farm, ranch, or lot. The compliance date for these enhanced record-keeping requirements is set for January 20, 2026.

The FDA has not created any template for manufacturers to draw on and compliance relies on efficient planning that begins now.

What's Inside 

  • Changes to items on the Food Traceability List 

  • Exemptions and clarifications on new rule requirements

  • Guidance for a successful Food Traceability Plan and tips for implementation

Download Your Copy