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FDA’s New Food Traceability Rule: Resources to Help Your Organization Prepare

adminOctober 9, 2024

About 1 in 6. According to the U.S. Department of Health and Human Services (HHS), that’s the number of people in the U.S. that get foodborne illnesses each year. 

“Many foodborne illnesses are caused by bacteria, like Campylobacter, E. coli, Listeria, and Salmonella,” HHS says. “Each year in the United States, more than 100,000 people go to the hospital and 3,000 people die because of foodborne illnesses.”

Although foodborne illnesses can be the result of unsafe food practices at home, they can also be due to a breakdown in food safety within the supply chain — underscoring the importance of the ability to trace food products and identify the culprits when a new outbreak occurs. 

Which is where a new regulation from the U.S. Food and Drug Administration (FDA) comes in. Here, we’ll provide an overview of the new rule, challenges to implementation, and resources to help your organization get ready for the rapidly approaching compliance date. 

Food Traceability Final Rule

According to the FDA, the 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 FDA says the final rule is a key component of the agency’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA): “The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.” 

The agency says that at the core of this rule is “a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed,” and that 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.”

Although the new regulation will impact stakeholder organizations of all sizes within the food supply chain, the FDA decided to issue the same compliance date — which is January 20, 2026 — for “all persons subject to the requirements.”  

Key features of the Food Traceability Final Rule

The FDA says key features of the new regulation include the following. 

Critical Tracking Events (CTE) 

“The final rule identifies Critical Tracking Events (CTEs) for which records containing Key Data Elements (KDEs) will be required,” FDA says, noting that the KDEs required will “vary depending on the CTE that is being performed.”

In the final rule, CTEs include: 

  • Harvesting
  • Cooling (before initial packing)
  • Initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel
  • First land-based receiving of a food obtained from a fishing vessel
  • Shipping
  • Receiving
  • Transformation of the food

For specific descriptions of each, please see the FDA resource.

Traceability Lot Code

According to the FDA, the traceability lot code (TLC) refers to a “descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

The agency says businesses must assign a TLC to a food on the FTL when they do any of the following:

  • Initially pack a raw agricultural commodity (RAC) other than a food obtained from a fishing vessel
  • Perform the first land-based receiving of a food obtained from a fishing vessel
  • Transform a food

“If you receive an FTL food from an entity that is exempt from the final rule, you must assign a TLC if one has not already been assigned (unless you are a retail food establishment or restaurant),” FDA says. “Otherwise, you must not establish a new TLC when you conduct other activities (e.g., shipping) for a food on the Food Traceability List. Once a food has been assigned a TLC, the records required at each Critical Tracking Event (CTE) must include that TLC. All of the Key Data Elements (KDEs), including the TLC, must be linked to the relevant traceability lot.”

Traceability Plan 

Businesses that fall under the final rule requirements must “establish and maintain a traceability plan” that contains the following:  

  • A description of the procedures used to maintain required records related to the rule, including their format and location
  • A description of the procedures used to identify foods on the FTL that the company manufactures, processes, packs, or holds
  • A description of how TLCs are assigned to foods on the FTL
  • Identification of a contact person for questions regarding the traceability plan and records
  • A farm map indicating the areas in which foods on the TLC (other than eggs) are grown or raised

Additional Requirements 

The final rule also requires affected businesses to:

  • Maintain original records in paper or electronic form, or as “true copies,” ensuring they are legible and stored in a manner that prevents “deterioration or loss.” Additionally, electronic records may include “valid, working electronic links to the information required to be maintained under the rule.”
  • Make all required records, along with “any information required to understand the records,” available to the FDA “within 24 hours after a request is made (or within a reasonable time to which the FDA has agreed).” 
  • Provide the FDA with an “electronic sortable spreadsheet containing relevant traceability information” within 24 hours of a request (or within some reasonable time to which the FDA has agreed) “when necessary to assist the FDA during an outbreak, recall, or other threat to public health.” 

Challenges and Concerns

Although the Food Traceability Rule will help to improve food safety, a recently released report indicates that industry stakeholders have a number of concerns when it comes to implementation. 

In a series of interviews and roundtables conducted by the Reagan-Udall Foundation for the FDA (Foundation) in Spring 2024 to better understand industry perspectives and challenges on the topic, several key concerns were identified.  

  • Awareness: “Participants described low awareness of the rule and its specific requirements across the food system, especially among certain industry sectors, small and medium-sized suppliers, foreign suppliers, non-chain restaurants, and companies not connected to a trade association. …” 
  • Traceability Lot Code & Labeling: “… Several concerns were raised about the new TLC requirements, including discussion of the level of labeling and tracing activity necessary to generate the required information. … Key TLC themes emerged around defining, capturing, and sharing the TLCs, assuring accuracy and allowing flexibility, and storage of TLCs in case of an investigation. …”
  • Warehouse Management System Capability: “A significant operational challenge of the final rule occurs within food warehouse management,” with specific concerns about the variable capabilities of warehouse management systems, how to handle TLCs at the pallet level, the potential costs for new technology, more space, increased labor, and more.
  • Technology: “Various technology systems (such as master data management systems, warehouse management systems, enterprise resource planning systems, third party traceability systems) may support compliance with the rule, but industry must evaluate multiple aspects, ranging from functionality to storage capacity to connectivity with internal and external systems. …”

Resources to help with preparation and compliance

Although industry stakeholders are expressing concerns about implementing the final rule, the good news is there are several initiatives aiming to help. 

New implementation guidance from the Product Traceability Initiative

On February 13, the Product Traceability Initiative (PTI) announced the release of its new guidance related to FSMA 204 implementation. 

“The Produce Traceability Initiative (PTI), founded more than 15 years ago to advocate for food traceability, has worked with over 100 industry representatives to develop the PTI FSMA 204 Implementation Guidance, including information by supply chain role,” the press release said. “Although FSMA 204 is applicable to foods listed on the FTL only, major U.S. buyers intend to require the same data set for all produce items received.”

“The requirements of the Produce Traceability Initiative for case-level traceability are aligned with the Final Rule and cover approximately 90-95% of the requirements,” according to PTI. “What is new to PTI is the Traceability Lot Code Source and the Traceability Lot Code Source Reference.”

A list of new and updated FSMA 204 resources are available on the PTI website. 

New resources from GS1 US

On March 13, GS1 US® — which refers to itself as a “not-for-profit, global data standards organization that creates a common language for companies to identify, capture, and share trusted data that links their physical and digital supply chains” — announced the release of a suite of resources to help the food industry comply with the new regulation.  

“GS1 US has published a new suite of resources to help companies address the requirements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act Traceability Rule (FSMA Rule 204),” the press release said. “The documents are designed to help trading partners understand how they can use GS1 Standards to meet the stringent recordkeeping requirements for ‘high-risk’ foods.”

The new resources include:

  • “Retail Grocery and Foodservice Application of GS1 System of Standards to Support FSMA 204” Guideline (updated to version 2.0) which was “prepared by the GS1 US FSMA 204 Workgroup industry members to assist the U.S. food industry with implementing GS1 Standards for traceability and specifically to help meet the requirements.”
  • “GS1 US EPCIS Recommendations for FSMA 204 Critical Tracking Events,” which “shows how the Electronic Product Code Information Services (EPCIS) Standard can be used to capture supply chain events and what information from those events can be used to supplement the needed data for FSMA Rule 204 CTEs and KDEs. The EPCIS Standard is designed to capture when and where supply chain objects are involved in many different processes, including when they are created and when they are transferred between trading partners and locations.”
  • “GS1 US EDI Implementation Recommendation for FSMA 204 Critical Tracking Events,” which “supplements the new Guideline by providing direction for implementing the X12 Electronic Data Interchange (EDI) 856 Advance Ship Notice to help meet the Shipping CTE requirements of FSMA Rule 204. It seeks to increase consistency and ease of implementation by explaining the data elements and codes and providing real-world examples. This document provides guidance on how to incorporate the additional data required by FSMA Rule 204 into existing EDI implementation.”
  • “How to Apply GS1 Standards for FSMA 204 Requirements,” an e-learning course, is also available: “The module provides an interactive overview of FSMA Rule 204 requirements and how to utilize the GS1 System of Standards to help meet those requirements.”

“Together these new GS1 US resources form a substantial foundation of guidance for companies to follow in implementing GS1 Standards to meet FSMA Rule 204 requirements,” said Melanie Nuce-Hilton, senior vice president, community engagement, GS1 US. “As the January 2026 compliance deadline for the FSMA Rule 204 approaches, taking steps now to digitize data and recordkeeping systems to share information more efficiently will help to create safer and more resilient food supply chains.”

Food Industry FSMA 204 Collaboration

On September 10, the International Foodservice Distributors Association (IFDA) announced a new collaboration to help address FSMA Rule 204 challenges. 

“Eight prominent food industry organizations have united to form the “Food Industry FSMA 204 Collaboration” to enhance industry-wide awareness of the U.S. Food and Drug Administration’s (U.S. FDA’s) Food Traceability Rule, which implements Section 204(d) of the U.S. FDA Food Safety Modernization Act (FSMA),” according to the press release. 

Participating organizations include: 

  • Association of Food and Drug Officials (AFDO)
  • The Food Industry Association (FMI)
  • GS1 US
  • Institute of Food Technologists (IFT)
  • International Foodservice Distributors Association (IFDA)
  • International Foodservice Manufacturers Association (IFMA)
  • International Fresh Produce Association (IFPA)
  • National Association of State Departments of Agriculture (NASDA)

“The Collaboration will share clear, concise messaging and resources that enable industry to take action in preparing for FSMA Rule 204,” the press release said, adding that it will provide a “forum where business and government officials can come together to educate industry and potentially help ease the burden of compliance.” 

IFDA says the Collaboration is founded on “core principles,” which include:

  • Operational effectiveness through collaboration
  • Traceability for enhanced food safety
  • Standardized data collection
  • Widespread training and education initiatives

“The Collaboration prioritizes the enhancement of awareness and understanding of emerging traceability technologies to help ensure the safety and integrity of the food supply chain,” according to the announcement. “Through united efforts, the Collaboration promotes acceleration of industry-wide compliance with FSMA Rule 204.”

For more, check out these additional resources:

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