In November 2022, U.S. Food & Drug Administration released the 597-page “FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods.” These regulations will be enforced starting on Jan. 20, 2026.
FSMA 204 applies to all fresh produce items on the Food Traceability List, including imported product from outside the United States. The Final Rule applies to persons (not facilities) who manufacture, process, pack or hold foods that appear on the Food Traceability List or foods that contain a listed food as an ingredient.
The implementation of FSMA 204 is expected to reduce traceback and trace-forward investigations from five to six weeks to five to six days.
This rule requires entities that harvest, cool, pack, transform, ship and/or receive food on the Food Traceability List, to establish and maintain records at these Critical Tracking Events containing certain information (Key Data Elements and link that information a traceability lot code. Entities that do not take physical possession of foods on the FTL are not covered by this rule.
The following fresh produce items are included on the Food Traceability List: fresh cucumbers, fresh herbs, fresh leafy greens (including fresh cut leafy greens), fresh melons, fresh peppers, fresh sprouts, fresh tomatoes, fresh tropical tree fruits, all fresh cut fruits, all fresh cut vegetables, ready-to-eat deli salads as well as some seafood, eggs and nut butters.
The traceability lot code assigned at the time of initial packing must be captured, stored and shared through the supply chain from packing all the way to a retail store or foodservice operation/restaurant. As well, the traceability lot code source consisting of the name, address and phone number of the location that the food was packed must be captured, stored and shared through the supply chain from packing to a retail store or food service operation/restaurant.
A common question is “Does FSMA 204 apply to my company?” There are full and partial exemptions for certain entities. FDA have created a tool to determine if your company is exempt.
The Final Rule requires entities to send an electronic sortable spreadsheet to FDA within 24 hours of the FDA notifying them that they are involved in a traceback investigation. The Produce Traceability Initiative volunteer working groups have created a PTI FSMA 204 implementation Guidance Document to assist industry members in complying with FSMA 204 and creating the electronic sortable spreadsheets to send to FDA. They have created sample spreadsheets for each role in the supply chain.
FSMA 204 is applicable to foods listed on the FTL only. However, the major buyers in the U.S. intend to require the same data set for all produce items received. For items not on the Food Traceability List, the Traceability Lot Code Source could be the corporate office contact information rather than the location where the product was packed.
The requirements of the Produce Traceability Initiative are aligned with the Final Rule and cover approximately 90-95 percent 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 is in development and will be published on the PTI website later this year. 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.
A Traceability Plan is required for all covered entities by FSMA 204. It is a roadmap of your traceability program and where things are located. Your traceability plan must include the following:
- A description of the procedures you use to maintain the required records, including the format and location of the records.
- A description of the procedures you use to identify foods on the FTL that you manufacture, process, pack, or hold and how you assign traceability lot codes to foods on the FTL, if applicable.
- A description of how you assign traceability lot codes.
- A statement identifying a point of contact for questions regarding your traceability plan and records.
- If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods, including the location and name of each field (or other growing area) in which you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing area.
You must update your traceability plan as needed to ensure that the information reflects your current practices and to ensure you are compliant with the rule. As well, you must retain your previous traceability plan for two years after you update the plan.
All records required under the rule must be maintained for 2 years from the date they were created and be made available to FDA within 24 hours of a request from FDA via phone, in writing or in person.
Offsite storage of the records is permissible, provided the records can be made available to an FDA representative no later than 24 hours after a request. Electronic records are considered onsite if they are accessible from an onsite location. Electronic records may include electronic links. Records also can be required to be provided in English within a reasonable time if they are maintained in a language other than English. Covered entities may enter into agreements with individuals or firms to create and keep the records required by the rule on their behalf. There is no requirement to create duplicate records or maintain information in a single set.
My recommendation to all companies that handle fresh produce is to start implementation of compliance with FSMA 204 today. Form a team and plan on piloting with your trading partners in advance of the enforcement date.