Navigating the New FDA Food Traceability Rule: Meeting Requirements and Enhancing Safety

Editor’s Note: This article was written by Angela Fernandez, senior vice president, market development, GS1 US.

The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) marks a crucial milestone in the agency’s efforts to fortify food safety standards. Enacted in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, the goal of FSMA is to address preventable foodborne illness as a significant public health problem and a threat to the economic well-being of the food system.

The FDA has finalized several major rules to implement FSMA — including the Food Traceability Rule which implements section 204(d) of FSMA — hence it is commonly referred to as “FSMA Rule 204.” It assigns new responsibilities to companies that handle certain foods at any point in the supply chain — from harvest or creation through production to point-of-sale or point-of-consumption.

The FDA set a Jan. 20, 2026, compliance deadline. With less than two years to go, it is important for anyone involved in the food supply chain to understand the rule and its requirements. Entities that are subject to the rule must begin preparing their systems and practices now for implementation.   

UNDERSTANDING THE RULE'S MANDATES. FSMA Rule 204 imposes rigorous record-keeping requirements on entities engaged in the “production, processing, packing or holding” of specific high-risk foods identified on the FDA’s Food Traceability List (FTL). These foods include leafy greens, fresh-cut fruits and vegetables, deli meats and ready to eat deli salads, seafood, cheeses and eggs, among others. FTL foods are specifically singled out for additional traceability measures because they have proven historically to be the source most of the foodborne illness outbreaks in the U.S.

Key requirements of FSMA Rule 204 include:

• Detailed Record-Keeping: Companies must maintain comprehensive records documenting key data elements (KDEs) associated with critical tracking events (CTEs) at various stages of the supply chain. The required records must be kept for at least two years.
• Unique Product Identification: Traceability lot codes (TLCs) must be assigned to foods on the FTL during specific activities (such as initial packing or transformation) to enable precise linking of the traceability records from production to distribution. ​TLC refers to a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned it. Once a food has been assigned a TLC, the records required at each CTE must include that TLC. All KDEs, including the TLC, must be linked to the relevant traceability lot. Companies that leverage GS1 Standards may use the GS1 Global Trade Item Number (GTIN) and lot code as the TLC.
• Traceability Plan: A traceability plan must be established and maintained, including procedures for recordkeeping, identification of foods on the FTL, assignment of TLCs, a point of contact and a farm map for relevant foods.
• Timely Reporting: In the event of a recall or foodborne illness outbreak, companies must provide the FDA with relevant traceability data within 24 hours of FDA request (or within some reasonable time to which FDA has agreed) to facilitate prompt and effective response measures. Companies with more advanced digital capabilities and systems are using technology to automate the process; a sortable spreadsheet is the minimum required by FDA.  
  

KDES AND CTES EXPLAINED. The FDA has defined a set of attributes, KDEs, that refer to critical information that must be documented for critical events, or CTEs, in the food supply chain. CTEs include events like harvesting, cooling, packing, manufacturing, processing, transforming, shipping and receiving. KDEs include the place where it is shipped, delivered, transformed or purchased.

These attributes and tracking events map directly to several GS1 Standards. These standards provide a globally recognized framework for product and entity/location identification and data exchange throughout the supply chain. GTINs identify products up and down the food supply chain and when used with batch/lot numbers can represent the Traceability Lot Code that links the different CTEs along the supply chain. Global Location Numbers (GLNs) identify entities and locations, which can be used to link company/location information to CTEs.

For detailed directions on applying voluntary GS1 Standards to satisfy the FSMA Rule 204 requirements, readers can refer to the materials available from GS1 US here.

DETERMINING OBLIGATIONS. First, figure out whether the business is subject to the rule requirements based on the foods the business produces and/or handles, what the business’ role within the supply chain is and the activities the business performs. Any business or entity that handles any of the foods listed on the FTL, including their use as ingredients, fall within the rule's purview. This includes growers, packers, processors, wholesalers, distributors, manufacturers, retailers and foodservice operators.

See if the activities performed within your organization for FTL foods are among the CTEs that require documentation under the rule.  If so, consult the rule to determine whether any exemptions apply to your specific situation here.

IMPORTANCE OF TRANSPARENCY AND TRACEABILITY. Transparency and traceability are crucial aspects of the food supply chain, playing a vital role in preventing the spread of foodborne illness. According to the Centers for Disease Control and Prevention (CDC), 48 million people in the United States get sick annually, leading to thousands of hospitalizations and even deaths.

In 2022 alone, the FDA witnessed product recalls hit a 10-year high, with 419 million units recalled, a 700.6% increase from the year before. This underscores the need for robust traceability measures to identify and remove contaminated products from the market promptly.

By implementing comprehensive traceability systems and maintaining accurate records, food producers and distributors can quickly trace the source of contaminated products and prevent further distribution, reducing the risk of widespread illness outbreaks. Moreover, transparency in the food supply chain builds consumer trust and confidence, empowering consumers to make informed choices about the products they purchase and consume.

COLLABORATION IS KEY. FSMA Rule 204 represents a significant step forward in strengthening food safety measures and protecting public health. A great deal of collaboration is needed to ensure the proper coding of required data so that it meets FDA requirements and can be ingested, understood and exchanged between trading partners throughout the supply chain. By adhering to the rule's mandates and leveraging digital technologies such as GS1 Standards, the food industry can enhance traceability capabilities, mitigate risks associated with foodborne illness, foster greater transparency throughout the supply chain and positively impact the bottom line.