Produce Traceability Initiative releases new FSMA 204 guidance

The Produce Traceability Initiative says it worked with more than 100 industry representatives to develop its PTI FSMA 204 Implementation Guidance, updated guidance that includes supply chain information.

This guidance is designed to help those who fall under the Food and Drug Administration’s “FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.” FDA will start enforcing these regulations Jan. 20, 2026.

PTI said the Food Safety Modernization Act or FSMA 204 applies to all fresh produce items on the FDA’s Food Traceability List, including imported products from outside the U.S. The final rule applies to persons who manufacture, process, pack or hold foods that appear on the Food Traceability List or foods that contain a listed food as an ingredient.  

PTI said that although FSMA 204 applies to foods listed on the FTL only, major U.S. buyers indicated an intention to require the same data set for all produce items received.

PTI said its requirements for case-level traceability align with FSMA’s final rule. The organization said what is new is its Traceability Lot Code Source and the Traceability Lot Code Source Reference. The organization said it will update its existing Why and How to Use EDI 856 Advance Ship Notice/Manifest Transaction and the Guidance for GLN Assignment documents.