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RegulatorySupply ChainFDAFSMATraceability/Recall

Food Safety in Transition: Looking Toward FSMA 204 Compliance

By Sara Bratager
women working in warehouse

Image credit: Drazen Zigic via Freepik

January 21, 2025

"Why are there so many food recalls?" has echoed through public discourse over the past year. The answer is not straightforward. Improved testing and monitoring, heightened consumer reporting, advancements in traceability capabilities, regulatory changes, supply chain globalization, and occasional lapses in sanitation and processing are all potential contributors.

Where preventive food safety measures fail to eliminate product defects, but reactive measures allow us to identify and track those defects through the food system, we have recalls.

Historically, reactive capabilities have been inadequate, resulting in prolonged recalls and widespread product removals due to insufficient traceability. The Food Traceability Final Rule, released by the U.S. Food and Drug Administration (FDA) in 2022, aims to disrupt this trend by improving the speed, precision, and scope of recall processes. The Rule has ignited activity across the food system. 

The compliance clock started ticking in January 2023 with food companies having three years to comply or face penalties. With one year left until the compliance deadline, significant progress has been made, but challenges remain.

Progress and Challenges

Regulators

FDA has worked to educate and engage with the food community in preparation for compliance with the rule. Since the release of the rule, FDA's library of Food Traceability Rule resources has ballooned, offering guidance documents, FAQs, and other tools to aid compliance efforts. Regulators have supplemented online resource development with staff members making in-person appearances at industry events and conferences to speak with food system stakeholders about the Rule. 

Additionally, the Reagan-Udall Foundation held a series of roundtables with industry members to share insights from those involved in implementation, identify and prioritize key issues, and explore implementation strategies. These valuable resources have helped, but there are still many gaps to fill, with increased funding for FDA needed to properly support the implementation of the Rule.

While regulators are steadily building awareness, the industry's readiness varies widely.

Industry

Several retailers have taken a comprehensive approach, mandating compliance across all suppliers' commodities—not just those handling foods on FDA's Food Traceability List (FTL). A Kroger letter to suppliers1 explained that the organization "intends to collect and record Traceability information for all food products entering Kroger facilities, to ensure the safety of food supply for every customer." Walmart has taken similar measures2 and expects compliance among suppliers by August 2025, although the company plans to limit initial monitoring efforts to those products on the FTL. The rule was designed with flexibility in mind so that it could easily be applied beyond the scope of products on the FTL. 

For distributors, the Rule presents significant hurdles. The Reagan-Udall Foundation report that summarized the industry roundtable series noted, "the capabilities of warehouse management systems are highly variable, and most are likely not capable of capturing all KDE [Key Data Element] data points without significant upgrades or overall system replacement." During a public meeting held in October 2024 that followed the release of the report, several participants expressed concern about receiving data from upstream distributors. 

Inadequate adoption of data standards exacerbates concerns about data-sharing among supply chain actors. The Food Traceability Rule provided the first step to achieving interoperability: defining what data needs to be collected, and when. The Rule did not, however, define how data must be formatted and shared. Without standardized data formatting and sharing protocols, moving data from one system to another can be costly and complex. Stakeholders across the food system are calling for widespread data standardization to enable seamless, interoperable data sharing. Established data standards, such as those maintained by GS1 US and the Global Dialogue on Seafood Traceability, provide a foundation for interoperable data exchange in food supply chains. Adoption continues to present a challenge, however, and there remains a need for collaborative approaches that tailor existing frameworks to address sector-specific traceability needs and practices.

Associations and Advocacy Groups

Multi-stakeholder working groups and coalitions have been supportive of the Rule and have played a significant role in supporting supply chain actors in their compliance efforts. IFT's Global Food Traceability Center recently partnered with GS1 US and seven other food organizations to form the Food Industry FSMA 204 Collaboration3 to provide educational resources and enhance industry-wide awareness of the Rule. 

Meanwhile, sector-specific initiatives, such as the Produce Traceability Initiative and the National Fisheries Institute, have fostered collaboration and shared resources, aligning their respective sectors in their approach to compliance.

Technology Providers

The technology landscape presents a mixed picture. Although technology capability remains a pressing concern for many supply chain actors, there exist numerous technology providers ready to tackle the compliance challenge. Technology providers present at the Reagan-Udall Foundation public meeting in October 2024 expressed that compliance with the rule is feasible, citing customers that have scaled, efficient traceability systems.  

At the industry scale, interoperability still presents a challenge among technology providers, yielding instances of data roadblocks and vendor lock-in. However, many solution providers are engaged in industry initiatives to standardize data formatting and sharing methodology to support interoperability and seamless data-sharing among distinct systems and providers. These initiatives will require time and investment—likely more time than remains before the compliance deadline—but they are critical in providing the foundation for more cohesive digital ecosystems in the future. 

Media

Media has played an active role in raising awareness about the Food Traceability Rule. Trade publications have published numerous sector-specific articles along the lines of "What X Needs to Know About the Food Traceability Rule," providing tailored insights for various stakeholders. Simultaneously, mainstream media coverage of high-profile recalls has kept food safety top-of-mind for consumers, helping ensure they avoid unsafe foods.  

Recall Data and Public Perception

Although high-profile recalls have dominated headlines, FDA's dashboard data4 does not demonstrate unprecedented recall numbers. However, bacterial contamination recalls have reached a five-year high,5 following the years of pandemic lows. An increase in bacterial contamination recalls leads to increased media coverage and public visibility, which may provide context for polls6 that show a decline in consumer confidence regarding the safety of the food supply.

Notably, while the Food Traceability Rule seeks to improve recall readiness across the board, most items on the FTL are those historically linked to bacterial contamination and foodborne illnesses such as nut butters, leafy greens, and fresh-cut produce.

A Shared Responsibility

The food industry stands at a pivotal moment. Regardless of regulatory pressures, traceability demands will persist. Potentially harmful products will still be identified. Recalls will still be initiated. Data will still be requested of all actors in the food supply chain. Regulators will still investigate outbreaks. 

Collaboration remains key. Stakeholders must continue working together to implement and enhance traceability systems—if not for the sake of regulatory requirements, then to ensure consumer safety and confidence.

With one year left until the deadline, the food community has made significant progress. Yet, the journey toward end-to-end traceability is far from over. The safety of consumers and the resilience of the food system depend on the collective effort to meet this challenge head-on.

To learn more about IFT's Global Food Traceability Center (GFTC) or the Food Traceability Rule, visit the GFTC website.

References

  1. The Kroger Co. "Re: The Kroger Co Food Traceability Policy & Requirements." December 1, 2023. https://edi.kroger.com/EDIPortal/documents/Maps/kroger-modernized-systems/Food%20Traceability%20Requirements.pdf.
  2.  Walmart. "Food Traceability Requirements." 2025. https://one.walmart.com/content/food-safety/en_us/food-safety-requirements/food-traceability.html.
  3. IFT. "Food Industry FSMA 204 Collaboration." https://info.ift.org/global-food-traceability-center-fsma-collab.
  4. FDA. "Recalls." 2025. https://datadashboard.fda.gov/ora/cd/recalls.htm.
  5. Holger, P. "Bacteria food recalls reach five-year high in 2024." Consumer Affairs. December 30, 2024. https://www.consumeraffairs.com/news/bacteria-food-recalls-reach-five-year-high-in-2024-123024.html.
  6. Yi, R. "Trust in Government Assurance of Food Safety Hits Record Low." Gallup. September 6, 2024. https://news.gallup.com/poll/650024/trust-government-assurance-food-safety-hits-record-low.aspx.   

 

KEYWORDS: Food Traceability Final Rule IFT

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Sara bratager

Sara Bratager is a Food Traceability and Food Safety Scientist at the Global Food Traceability Center (GFTC) at the Institute of Food Technologists (IFT). She enjoys applying years of traceability and food safety management experience in manufacturing toward GFTC's efforts to engage food system stakeholders in their traceability journey through applied research, capacity building, advocacy, system design, and implementation. Ms. Bratager and the GFTC team continue to support industry actors in their FSMA 204 compliance journey.

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