In providing temperature-controlled storage and transportation services throughout the food supply chain, food safety is of utmost importance to cold chain operators. Successfully managing the receipt, storage, and distribution of food is fundamental for third-party logistics providers, so the ability to track where products have come from, their current location, and where they are going has long been a priority for the Global Cold Chain Alliance (GCCA) and its members.

The U.S. Food and Drug Administration's (FDA's) Requirements for Additional Traceability Records for Certain Foods Rule, finalized in November 2022, is slated to add a complicated, new regulatory framework for tracing food throughout the supply chain. The Rule is a part of the overall Food Safety Modernization Act (FSMA) and will include enhanced recordkeeping for businesses that manufacture, process, pack, or hold the foods listed on the FDA's Food Traceability List (FTL). The new food traceability requirements will necessitate changes of approach, implementation of new systems, and increased collaboration throughout the food supply chain from farm to fork.

For successful realization of the consumer food safety ambitions behind these changes, the implementation of the new requirements must be smooth, measured, and well supported with guidance and learnings from pilot projects.

The FSMA 204 Rule

The enhanced traceability requirements established by the FSMA 204 Rule cover both domestic and foreign firms handling food for U.S. consumption, along the entire food supply chain. In March 2025, FDA announced its intention to extend the compliance date for the Food Traceability Rule by 30 months, pushing the deadline from January 20, 2026 to July 20, 2028. The extension comes after calls from industry and others have expressed the need for additional time. GCCA has requested such an extension directly to FDA, as well as through legislation introduced in 2024 entitled the Food Traceability Enhancement Act.

This welcome postponement of the compliance date for the Food Traceability Rule provides much-needed time for industry to meet the regulatory requirements. The Rule's complexity has raised concerns about the burden it places on businesses, and this additional time allows for further collaboration between industry stakeholders and regulators to address outstanding challenges. Pilots that include players from across the supply chain need to be conducted and their learnings applied. In addition, the extension of the compliance date will allow time for the refinement of compliance requirements and the development of further guidance.

Significant Change on the Horizon

The implementation of the Food Traceability Rule will mean significant change in the operation of the food supply chain. The Rule requires food supply chain businesses to capture, record, and share key data elements (KDEs) for designated critical tracking events (CTEs). This is an end-to-end activity, requiring information to be communicated from one tracking event to the next, both within each business in the chain and between multiple supply chain partners. Companies will need to track food products' journeys, deliver end-to-end product visibility, and collaborate through systems that can seamlessly recognize and share information. Interoperability will be critically important.

The scope and reach of the Food Traceability Rule will be extensive, impacting companies in the U.S. and across the world. The Rule will impact the entire food supply chain with complex product tracing and lot code requirements, resulting in de facto case-level tracking, which can be cost-prohibitive. Individual food products subject to the Rule will number in the tens of thousands, and some food companies have indicated that they will require the same treatment of foods not on the FTL. All businesses involved, from the producer through to retail establishments, restaurants, grocery stores, and convenience stores, will need to keep product information on a sortable spreadsheet and be able to produce this information within 24 hours for submission to the FDA, if requested. Companies will be required to maintain these records for two years, which is significantly longer than the short shelf life of most foods on the FTL.

New Approaches and Systems

Technology will be an important component of compliance for many companies in the food supply chain. A number of emerging approaches can support delivery of the Food Traceability Rule requirements by food supply chain businesses.

In terms of building visibility of each product across the supply chain, transitioning away from manual systems to digital systems can support accurate product tracking and location identification. A number of technologies can provide the framework for the tracking that is the cornerstone of Food Traceability Rule compliance, such as barcodes and QR codes to provide quick access to origin and journey information, radio frequency identification (RFID) tags attached to individual products or pallets for real-time tracking, blockchain technology for transparency and accountability, and Internet of Things (IoT) management platforms for automated, touchless, track-and-trace capabilities and analytics.

Enabling best practice data management, these tools can also support rapid supply chain response to a food safety concern by facilitating swift product tracing and accurate product removal.

A collaborative and interoperable approach throughout the supply chain will be essential for the successful implementation of FSMA 204. Digitized tracking throughout would enable users to follow food all the way through the supply chain, streamlines the compliance process, and can also highlight opportunities to improve operations. However, ensuring that supply chain partners' different warehouse management systems and product tracking systems can successfully and accurately pass and receive information between each other—which can be a complex operation—will be crucial.

Preparing for Compliance

In order to make decisions about investing in tools and systems such as these, food supply chain businesses need to have a full understanding of the Food Traceability Rule requirements, enabling them to assess the changes they will need to make to their current operations and supply chain interactions.

FDA's Food Traceability List plays a key role in understanding and applying the requirements, as it details which foods are subject to the FSMA 204 requirements. Businesses in the food supply chain are working to understand the list and assess how it impacts specific products and operations. It is important to note when specific product conditions are mentioned in the list. When a food is specifically mentioned as "fresh," then the frozen version of the product is not covered by the Rule. For example, while fresh spinach is on the list, frozen spinach is not covered by the Rule. Some products, like seafood, are listed with both fresh and frozen forms being covered by the Food Traceability Rule.

The Rule requires businesses to build traceability plans that include details of the procedures for identifying foods listed on the FTL and assigning Traceability Lot Codes (TLCs). Businesses will also need to determine which CTEs apply to their operations, and for which listed foods. This will help determine which KDEs they will need to collect for covered foods. It is good practice to document all preparation procedures and audit the information a business is receiving and communicating. Staff will be trained on the new requirements and on understanding how to deliver the appropriate response in a range of new scenarios.

Measured Implementation

The Food Traceability Rule requires significant changes to systems and operations across the entire food industry. Businesses of all types, sizes, and services need to understand the full requirements of FSMA 204 and assess what they mean for their operations. They must devise how these requirements can be met in practice and make investment decisions for the new systems and equipment required.

Substantial work will be required to manage the installation of new systems and equipment and deliver a comprehensive program of staff training on new requirements, processes, and systems. Businesses will need to trial their chosen approaches within their own operations, and also conduct trials alongside their supply chain partners. This will help them tackle the challenges identified before embedding the new product tracking and tracing procedures into their business culture. At a food industry level, this is a huge undertaking requiring a major investment of time, budget, and labor.

FDA has been engaging with the food industry, and has made the details of the Rule and a range of resources available on the FSMA section of the agency's website. These resources include papers on "Food Traceability Rule at a Glance" and "Getting Started with the Food Traceability Rule," the Food Traceability List, information on modifications and exemptions, supply chain examples, and frequently asked questions.

However, areas of ambiguity do still remain, and these will need to be clarified before businesses can start practical preparations in earnest.

GCCA has recently joined the Partnership for Food Traceability (PFT), an industry-driven, independent, sector-neutral nonprofit partnership that is working to address some of these issues. The PFT is developing a shared, overarching vision for food traceability across the supply chain to help support the streamlined implementation of compliant traceability systems. Importantly, FDA and state governments are also participating in the PFT and providing technical expertise. The primary objective of the PFT is to facilitate implementation of compliant traceability programs and the adoption of interoperable electronic traceability systems for FTL foods, while maintaining the flexibility to accommodate and support alternative and non-electronic methods for small businesses.

The PFT currently has two active committees, and GCCA is participating in both to ensure the voice of the cold chain is included. The Pilots Committee is consolidating pilot lessons learned to date and identifying gaps where additional pilot activity would be valuable. These learnings will be used to design operational pilots that will inform both industry and FDA ahead of the compliance date. The Traceability Committee is defining high-level concepts for traceability, such as how to manage and exchange Key Data Elements, and identifying other key issues that will impact operations and compliance.

Once the new compliance date is reached, initial agency enforcement activity should focus on education and compliance assistance. Like any major supply chain operational change involving multiple partners and systems, some disruptions should be expected as industry and government work to smooth implementation.

Improving food traceability through the implementation of the Food Traceability Rule aims to bring important benefits for food safety. Alongside our food supply chain partners, the cold chain is preparing to deliver against the new requirements. A well-supported and measured implementation schedule is crucial to securing those food safety benefits in practice and cementing them for the long term.

References

1. U.S. Food and Drug Administration (FDA). "Economically Motivated Adulteration (Food Fraud)." Content current as of April 18, 2024. https://www.fda.gov/food/compliance-enforcement-food/economically-motivated-adulteration-food-fraud.
2. Everstine, K., J. Spink, and S. Kennedy. "Economically Motivated Adulteration (EMA) of Food: Common Characteristics of EMA Incidents." Journal of Food Protection 76, no. 4 (April 2013): 723–735. https://pubmed.ncbi.nlm.nih.gov/23575142/.
3. Grigoriou, K. "When Lies Cost Lives: Economically Motivated Adulteration in the Food Industry." FOODAKAI. https://www.foodakai.com/when-lies-cost-lives-economically-motivated-adulteration-in-the-food-industry/.
4. Brevett, C.A. and J.A. Cox. "Intentional Adulteration of Foods with Chemicals: Snapshot for 2009–2022." Journal of Food Protection 87, no. 7 (July 2024): 100305. https://pubmed.ncbi.nlm.nih.gov/38796113/.
5. FDA. "Protecting the Food Supply from Intentional Adulteration, such as Acts of Terrorism." Content current as of July 15, 2020. https://www.fda.gov/food/conversations-experts-food-topics/protecting-food-supply-intentional-adulteration-such-acts-terrorism.