For Immediate Release: February 13, 2024
In November 2022, US Food & Drug Administration (FDA) released the “FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.” These regulations will be enforced starting on January 20, 2026.
The Food Safety Modernization Act or FSMA 204 applies to all fresh produce items on the Food Traceability List (FTL), including imported product from outside the United States. The Final Rule applies to persons who manufacture, process, pack or hold foods that appear on the Food Traceability List (FTL) or foods that contain a listed food as an ingredient. The Produce Traceability Initiative (PTI), founded more than 15 years ago to advocate for food traceability, has worked with over 100 industry representatives to develop the PTI FSMA 204 Implementation Guidance, including information by supply chain role.
Although FSMA 204 is applicable to foods listed on the FTL only, major U.S. buyers intend to require the same data set for all produce items received.
The requirements of the Produce Traceability Initiative for case-level traceability are aligned with the Final Rule and cover approximately 90-95% of the requirements. What is new to PTI is the Traceability Lot Code Source and the Traceability Lot Code Source Reference. A guidance document on the Traceability Lot Code Source Reference was also posted on the PTI website today. The existing Why and How to Use EDI 856 Advance Ship Notice/Manifest Transaction and the Guidance for GLN Assignment documents are being updated and will be published on the PTI website later this year.
The PTI sponsoring organizations would like to extend our sincere thanks to the 100+ industry members who worked on the five working groups that together developed this industry guidance and continue to support the efforts as noted above. As support documents are finalized, the PTI website will be updated to support industry implementation.
Contacts: See list of sponsoring organization contacts on the PTI website.
