By Mike Schwartz, Senior Vice President, Member Value
July 2024
- The new FDA requirement, FSMA 204, mandates that by January 2026, companies involved in the food supply chain must maintain detailed records of food traceability to improve food safety and expedite the response to foodborne illness outbreaks.
- FSMA 204 requires tracking Key Data Elements (KDEs) and Critical Tracking Events (CTEs) for foods on the Food Traceability List (FTL), covering everything from farm fields to consumer purchases.
- Companies need substantial lead time, ranging from 6-14 months, and significant financial investment to upgrade systems and technology for FSMA 204 compliance, highlighting the importance of starting preparations immediately.
- IFMA is compiling resources and hosting educational sessions to ensure that the industry is informed, ready, and prepared.
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Some might say that January 20, 2026, is a good long while from now. After all, if you were invited to a wedding that’s nearly 18 months away, you wouldn’t be stressing out now about your travel plans. If you planned to move more than a year from today, you wouldn’t be packing this afternoon.
But if you must make a substantial upgrade to the way your entire company maintains your business records, believe me; January 2026 is coming right up.
Say ‘Hello’ to FSMA Rule 204 and its implementation deadline.
FSMA 204 is a new FDA requirement for anyone who manufactures, processes, packs, or holds foods that are on an established Food Traceability List (FTL). Starting in January 2026, these companies must maintain records of specific information about that food and be capable of providing that information to the FDA quickly. The rule covers domestic and foreign firms producing food for U.S. consumption, all along the supply chain. The requirements will assist the FDA to more rapidly and effectively track the movement of a food to prevent foodborne illness outbreaks and limit product recalls.
That all sounds great, right? As consumers and business owners, we applaud improvements to food safety and new processes that will more quickly address problems arising from food. But implementing FSMA 204 is a big lift for our industry.
The FTL covers items like many types of fresh produce, a wide range of cheeses, nut butters, some categories of seafood, and ready-to-eat deli salads. You can view the full list on the FDA site. Every company along the supply chain must keep track of a defined set of metrics that the FDA calls Key Data Elements (KDEs), and all the places where the food is shipped, delivered, transformed, or purchased, called Critical Tracking Events (CTEs).
Given the magnitude of companies involved in the food supply chain, the transfer and “passing along” of consistent KDE and CTE data by each entity (farm fields/harvesting to processing/manufacturing to distribution to operator/restaurant to consumer) is the most critical element for FSMA204 compliance. The actual handling stages in the lifecycle of food products is found in these two sets of data.
There is no question, as identified by FSMA 204 subject matter experts and the federal government, that all food companies will need to invest heavily in system upgrades and technology that will enable the ability to capture the many steps involved in both producing KDE and CTE information. The lead time required to accurately provide all the data required is more than a 6-8 month time frame if your organization already has a base reporting system. In the event your organization is just getting started, the lead time will be more than 12-14 months. The financial investment will also be significant given the many providers that can be deployed depending on operating technology platform each trading partner depends on.
If you have not begun to prepare for what FSMA 204 will do to your operation, now is definitely the time to mobilize your organization, specifically around the time frame and financial implications ahead. One other key element to consider in this process is the transparency that is required and the data sharing between trading partners that must be agreed upon prior to any execution of a compliance plan. Time and money again become the motivating factor in meeting the compliance deadline and avoiding significant fines and potential operating shutdowns that the government can implement.
In the future, with everyone adhering to these requirements, we will have true traceability of these foods from farm to plate. FSMA 204 establishes the first-of-its-kind standardized approach to recordkeeping across the food supply chain, paving the way for our industry to use more effective traceability systems across our entire ecosystem. It will allow for quick identification of the source of any contaminated products, limiting the scope of recalls and waste, and reducing the risk of illness or death.
Of course, standardizing recordkeeping across an industry as huge as ours is daunting. Here at IFMA, we have invited experts from GS-1 US to several of our events to address the challenges surrounding FSMA 204.
GS1 is a not-for-profit, global data standards organization, best known as the only official provider of EAN/UPC barcodes. Suppliers, distributors, trade associations, and others are currently collaborating with GS1 US to build greater confidence in food traceability in anticipation of FSMA 204 implementation.
We recommend that if you are not yet aware of GS1’s work on these new traceability requirements, that you get to know them. See their website information on food safety here. They can help you better understand what you must do to be compliant with the new rules and how to implement new processes into your recordkeeping.
IFMA’s annual virtual Marketing and Sales Conference, August 6-8, will include a session on FSMA 204 (access will be both live and on-demand for several weeks afterward). The conference is open to everyone in the industry, you may learn more and register here. We will also cover the implications of the FDA’s food traceability requirements at our Presidents Conference in November, more here.
Although technology used for traceability has advanced to be a lot more cost-feasible, no "no-cost" solutions exist. Also remember that 18 months isn’t very much time. If you haven’t started addressing what your company needs to do to meet the FSMA 204 requirements, start now! For anyone who doesn’t touch any of the foods on the current FTL, consider that the FDA is almost certain to expand that list considerably in the next few years. Stay aware and leverage IFMA and the available industry resources to stay ahead.