With over 200 years of industry experience, Share-ify’s team of professionals offer unmatched expertise to assist your company with traceability and record keeping requirements.
The rule becomes effective on January 20, 2026, thereby giving companies less than 3 years to identify a technology partner, create a plan, implement a system, and have it in production use. To learn more about Share-ify’s Critical Tracking Event solution, click here. To learn more about Share-ify’s case and pallet labeling solution, click here.
While many companies call this “FSMA 204” it is formally know as the Food Traceability Rule or “FTR.”
In 2011, Congress passed the Food Safety Modernization Act (FSMA) which included a provision directing FDA to establish record keeping requirements for designated foods that would be additional to the existing traceability record keeping requirements. The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA)
To begin, assess where you are today. You can start to review the Food Traceability List (FTL) to assess whether any product your company is selling is currently subject to the Food Traceability Rule. Click here for the list. Be sure to see whether your product may be subject to exemption. Click here for information.
Next, what Critical Tracking Events (CTE’s) does your company conduct? The Final Rule lists 7 types of CTE’s. Click here to see the list. Evaluate which ones apply to you.
After that, take note of what Key Data Elements (KDE’s) you are already collecting and which ones you are missing in your current process. Click here to see details.
Finally, the proposed rule requires the assignment, recording, and sharing of Traceability Lot Codes (TLC’s). Traceability Lot Codes must be linked to other identifying information as they move through the supply chain. The basic requirement of the rule is that this information be shared within 24 hours via an electronic sortable spreadsheet.
Working with a technology provider helps companies gain business value that goes beyond compliance with the law. Share-ify offers company the ability to utilize information to improve on your brand promise with your customers and trading partners.
Sharing information may be a key hurdle for many companies. The final rule applies to all persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), including food importers. Entities covered by the rule may designate entities that are not covered, such as importers or brokers who do not hold the food, to maintain traceability records on behalf of the covered entity. Make sure you have a technology partner that can help you think through these kinds of complex details in your supply chain.
For FSMA 204, companies must establish and maintain a traceability plan that contains the following information:
(1) A description of the procedures you use to maintain the records you are required to keep (including the format and location of these records).
(2) A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold;
(3) A description of how you assign traceability lot codes (lot code formulation) to foods on the Food Traceability List
(4) A statement identifying a point of contact for questions regarding your traceability plan and records;
(5) If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
(i) Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
(ii) For aquaculture farms, the farm map must show the location and name of each container ( e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.
(b) You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.
To learn more about Share-ify’s solution and how we can help you comply with FSMA 204, click here.
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