- The time to start is now for companies that make, handle or sell foods in the FDA’s list of high risk foods – produce, fish and nut butters.
- Some retailers are in discussions and pilots with food brands to ensure they can share digital data about the product’s supply chain.
Legislation that might be driving technology adoption is approaching its January 2026 due date—The Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) 204.
FSMA is leading food companies to seek a clear and, in some cases, automated view into their supply chain. The new rule, several years in the works, will require some food makers, transporters and retailers to share a digital view of the product from field or farm to plate. While the rule doesn’t require any technology—only a sortable spreadsheet to be sent to the FDA within 24 hours—some companies are taking technology adoption further.
FSMA 204 comes from a broader rule: the Food Safety Modernization Act that has been in place since 2011. It outlines the responsibilities for each supply chain stakeholder in order to make the food supply safer, said Lucelena Angarita, supply chain visibility director at GS1 U.S. Angarita assists companies understand their compliance requirements, which go into effect Jan 20, 2026.
The rule was aimed at replacing a less cohesive approach to specific, high-risk foods. Although data is being collected about conditions around food, it has been hard for the FDA to connect the pieces of the puzzle when different stakeholders would send them information to serve a foodborne illness investigation for example.
“They could not tie those records together, there was a lack of identifiers to connect the dots,” Angarita said.
According to the FDA
Because the Food Traceability Final Rule requires entities to share specific information with other entities in their supply chain, FDA officials recommend the most effective and efficient way to implement the rule is to have all persons subject to the requirements come into compliance by the same date.
At the core of this rule is the need for companies to maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or another agreed upon timeframe.
The food traceability list includes cheeses and other dairy products, fresh produce, seafood and nut butters. Foods for animals are not included in the current risk-ranking model and therefore not covered by the final rule. Critical tracking events include harvesting, cooling, initial packing, shipping, receiving, transformation, first and-based receiving event, and traceability plan (the procedure to maintain the data).
Pervasive Foodborne Illnesses
Statistics from the Center for Disease Control (CDC) and prevention have found that every year four million people—one in six Americans—contracts a foodborne illness. Of those, reporting found, 128,000 are hospitalized and 3000 die.
With FSMA 204 deadline approaching, early planning is underway. Some of the leading retailers and operators have aligned on a minimal deployment plan to meet the requirements of the new rule. “These companies are agreeing not to ask for a million different things but just focus on what’s needed for that deadline,” said Angarita.
Companies that make perishable and risk-adverse foods are well aware of this pending mandate, but she added “there’s still a lot of education and awareness that is needed,” and companies can gain some of that from each other, from industries groups, and from GS1 U.S.
Following a High Risk Food Template
The rule doesn’t require any labeling nor any specific technology. What it does require is that every stakeholder—from manufacturers, processors and those further down the supply chain—collect data that’s accessible to other members of the supply chain.
“There are some exemptions based on revenue, or if goods are sold through a local market, however the directive indicates a record needs to be accessible,” said Angarita. Not all data needs to be collected and accessed, she added, just shipping events.
When the list was released, GS1 U.S. met with industry members and plotted out a specific actionable guidelines and best practices related to the record-keeping mechanisms to use. It begins with the advanced ship notice (ASN), a process companies are already familiar with.
Regardless of the version that a food company is using for their ASN, that form will include the FSMA specific key data elements or attributes that need to be collected and sent to the next trading partner for the shipping event record. That data includes the “ship from” location, “ship to” location, the product’s lot code as well as the place where that product was packed or manufactured – all could be linked to the ASN.
Strategizing the Way Forward
Beyond the ASN, companies should collaborate to ensure they are all planning to collect the data in the same language that all will understand. “Best practices is to use a common language for retailers operators and even suppliers, distributors, associations regardless of how the data is being captured,” Angarita said: barcode, 2D barcode or RFID technology can help automated for greater efficiency and accuracy.
In fact, some operators and retailers already have been undertaking pilots with RFID tags on products packed into cases, which then serves as the data carrier.
Whether or not RFID is used, products companies will assign identifiers like Global Trade Item Numbers (GTINs) to the products. It will then be easier to share that product information through GS1’s global data synchronization network—the GDSN, global data synchronization network, said Angarita.
Starting With Higher Volume Players
Users who create a GTIN, a date, and lot number would be able to meet the mandate and could benefit from inventory management, Angarita pointed out, including identifying any inefficiencies around inventory management and better manage their stock rotation for freshness. “One thing we’d like to tell our members and the industry is: focus on the highest volume suppliers or trading partners you have first,” she said.
Angarita pointed out that for many companies, 20 percent of their suppliers contribute 80 percent of the product volume. “So focus on them,” she said.
Those early discussions should include finding out if they are using ASNs today, do the ASNs have all the attributes for FSMA 204, and how they might add these specific attributes once the ASN is in place. Along the supply chain, FSMA 204 also requires several critical tracking events to be captured and recorded for the FDA as needed: when a product is harvested, when it’s cooled (transformed) initially, when it’s packed, shipped and received at a store.
GS1 U.S. advises that data can be structured in a specific language known as Electronic Product Code Information Services (EPCIS). GS1 recommends use of EPCIS for all supply chain events — the majority of food companies are familiar with the language, while it has a long history in healthcare and pharmaceutical tracking.
The critical tracking events are, for example: harvesting, transforming, shipping and receiving. The key data elements answers the questions of what the event consisted of, when it occurred, where and why.
When Goods are Broken Down
Sometimes users repack product on different pallets or in different cases, at which time they may not need a new lot code. For instance, if a salad mix company uses five incoming ingredients to make the salads they ship to retailers; they need to capture which ingredients went to the salad as part of their Food Traceability List (FTL) and the final product that was made. They can then share that data with the FDA as requested.
“It’s not required to share all that with the downstream trading partners,” Angarita said. What is required to be shared is the shipping event information and related lot code.
Companies also need a traceability plan. “When the FDA comes knocking on someone’s door after January 20, 2026 they’re going to say OK I need these records within 24 hours,” and users need to be ready to provide the basics of each critical tracking event and their related key data elements, said Angarita. The records need to be stored for at least two years.
Steps to Address Visibility
Analysts are urging companies that haven’t done so yet to assemble a task force across the product’s constituencies, trading partners, and customers. After that is done, they should confirm whether the lot IDs are associated with pallets or logistics units such as cartons, then confirm the ID is unique. The following step should decide if EPCIS will be the shared language.
With each product shipment, companies will need to have a link between the product’s traceability lot code and the pallet. For distributors, upon receiving, they can confirm that when they receive the goods, they can scan a pallet’s barcode and view or access the advanced shipping notice.
When it comes to software management, if EPCIS is not being used, companies need to ensure their partners can work with their system of documentation, whether it’s a spreadsheet (the minimal requirement from the FDA) or another software system.
Food associations are developing guidelines to meet FSMA 204 to help guide companies from produce farmers to fishermen create the GTIN. The industry groups have aligned to use a GTIN and lot ID to guarantee the unique identity of a product.
Finding Resources
Companies still seeking more clarity in the system can access resources by joining industry webinars in which companies share with their communities, for example the National Fisheries Institute, Produce Traceability Initiative and Food Industry Association.
‘These associations have partnered to say: these are all the educational materials and we’re not stepping on each other’s toes, we’re actually all agreeing that this is the best way to do it,” said Angarita.
GS1 is working with some leading operators and retailers that are in the process of implementing and testing the data management. “Several of them have already sent out supplier requirement letters saying this is what we need from you and here are some examples,” stated Angarita. The point is to keep the planning simple, initially. “They realize the more they deviate from that common vision the harder it’s going to be for suppliers or for smaller companies to meet those requirements.”
Years in the Planning
Since the proposed rule was announced in September 2020, GS1 has been talking to its members. It created a FSMA 204 Work Group to develop guidelines and tools, since November, 2021. “We started talking about all the data that’s required and it seemed a little bit overwhelming,” Angarita said. “But having all voices represented helped: [including] the distributors the suppliers, the retailers, solution providers, operators associations.”
GS1 aims to be a bridge with a neutral perspective where people can talk to their competitors, to come up with solutions.
“The competitive environment is not going to help” she pointed out. “This is not a competitive advantage and people are realizing that more and more.”
Time to Start is Now
Anyone who may have to meet the rule will benefit from starting now. “Don’t wait because some people are still saying, ‘Oh let’s see if it changes,’” Angarita said. Such late arrivals to the program are going to have to catch up when the deadline approaches.
The final rule aligns with current industry best practices and covers domestic, as well as foreign firms producing food for U.S. consumption, along the entire food supply chain in the farm-to-table continuum, according to the FDA.