WASHINGTON, DC - After the United States Food and Drug Administration released the “FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods,” in November of 2022, many have wondered how to navigate these new waters. After all, these regulations will begin to be enforced starting January 20, 2026. Not entirely that far away with an industry that moves as quickly as ours.

Luckily, the Produce Traceability Initiative (PTI) has worked with over 100 industry representatives to develop the PTI FSMA 204 Implementation Guidance, including information by supply chain role.

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. According to a press release, the Final Rule applies to persons who manufacture, process, pack or hold foods that appear on the FTL or foods that contain a listed food as an ingredient.

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 release went on to note.

The requirements of the Produce Traceability Initiative for case-level traceability are aligned with the Final Rule and cover approximately 90—95 percent of the requirements. What is new is the Traceability Lot Code Source and the Traceability Lot Code Source Reference. 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.

As support documents are finalized, the PTI website will be updated to support industry implementation.