Roundtable Talks Bring FSMA 204 Compliance Concerns to Light

With the compliance date for the U.S. Food and Drug Administration's (FDA's) Food Traceability Final Rule a little more than 15 months away as of the time of this publication, industry and regulators continue to stay engaged—especially regarding industry's concerns about meeting the deadline.

Fulfilling Section 204(d) of the Food Safety Modernization Act (FSMA), the Food Traceability Final Rule requires enhanced traceability along the food supply chain for foods listed on FDA's Food Traceability List. While industry generally agrees on the value of improved traceability, roundtable discussions conducted by the Reagan-Udall Foundation—the same organization that conducted the independent evaluation of FDA's Human Foods Program in 2022—have uncovered persistent concerns related to timing, traceability data elements, and business size and capabilities.

Industry Airs Concerns on FSMA 204

In the roundtable discussions, many participants suggested that a staggered approach to compliance be taken because purchasers downstream rely on information provided by suppliers upstream to implement full traceability. Specific questions were raised about the necessary levels and flexibilities of labeling, tracing, capturing, sharing, and standardization for Traceability Lot Codes (TLCs), which are data elements used to identify a food product as it moves along the supply chain. As the Traceability Rule requires food product recipients to share TLCs and TLC source information with FDA—which would create a strain on labor, equipment, and space if every case of food is scanned individually—industry has proposed the use of "most likely" lot codes or probability calculations as a mitigating solution.

Furthermore, not all warehouse management systems are capable of capturing Key Data Element (KDE) records without major overhauls that could take years to complete. Distributors closer to the end of the supply chain may carry thousands of different items covered by the Traceability Rule, with some pallets containing mixed lots or products, adding to the complexity of compliance for these stakeholders. Roundtable participants cited additional issues with low levels of awareness of the Traceability Rule and its specific requirements among small- and medium-sized suppliers, foreign suppliers, non-chain restaurants, companies unattached to an industry association, and certain industry sectors.

Stakeholders suggested that staggering implementation by sector or company size could enable industry to capitalize on learnings shared along the supply chain or between large and small entities. Sector-by-sector implementation, beginning at the start of the supply chain and progressing through to retail, could also create a roadmap to compliance, they said.

FDA and the Reagan-Udall Foundation plan to hold a virtual public meeting on October 7 to review what was revealed through the roundtable discussions and provide further opportunity to offer feedback. Additionally, a summary of the learnings from the Reagan-Udall roundtable discussions can be read here.

“One action item noted during the roundtable discussions has seen progress—the formation of a public-private partnership to support effective and consistent implementation of the Food Traceability Final Rule.”

Legal Challenges and Pilot Projects

The suggestions to stagger or delay implementation of the Traceability Rule and allow greater flexibility in TLC requirements are not the first proposals FDA has received along these lines. Two pieces of legislation have been introduced to Congress to achieve similar aims: the Food Traceability Enhancement Act, which would ease recordkeeping and TLC requirements for restaurants, retail food establishments, and warehouses; and a provision in the fiscal year 2025 agriculture appropriations bill that aims to put the January 2026 Traceability Rule implementation date on hold by demanding that FDA conduct additional traceability pilot projects. The Safe Food Coalition has urged Congress to reject the two legislative proposals, claiming that they undermine the Traceability Rule.

Since the release of the Traceability Rule in November 2022, multiple traceability pilot programs have been conducted by industry to test current systems and identify necessary changes. Most of these pilots have been conducted independently and have focused on only one food product or category. Reagan-Udall roundtable participants discussed the value of additional pilots, including integrated pilots scaled beyond a solitary product or facility and tailoring pilots to small, intermediate, and larger businesses.

New Partnerships for Traceability

One action item noted during the roundtable discussions has seen progress—the formation of a public-private partnership to support effective and consistent implementation of the Food Traceability Final Rule. Announced on September 4, the Partnership for Food Traceability (PFT) serves as an independent, sector-neutral forum for industry, regulators (including FDA, state, and local officials), industry associations, technical experts, and technology vendors to facilitate the wide coordination required to comply with FSMA 204. 

PFT will work toward defining a consistent set of business and functional requirements for traceability, a decision-making mechanism on industry's traceability implementation, and an organized plan for how industry can successfully achieve enhanced traceability. All resources created via the PFT will be open-source. The organization will also identify additional pilot needs and coordinate public-private engagement in future pilot projects.

In the same spirit of collaboration and transparency, eight leading food industry member associations announced on September 10 that they have joined forces to form the Food Industry FSMA 204 Collaboration, with the goal of enhancing industrywide awareness of the Traceability Rule. The organizations include the Association of Food and Drug Officials, FMI—The Food Industry Association, GS1 US, the Institute of Food Technologists, the International Foodservice Distributors Association, the International Foodservice Manufacturers Association, the International Fresh Produce Association, and the National Association of State Departments of Agriculture.

The Food Industry FSMA 204 Collaboration intends to distribute clear, concise messaging and resources that will help industry take action in preparing to comply with the Traceability Rule. It will also provide a forum where business and government officials can come together to educate industry and potentially help ease the burden of compliance. Through these efforts, the Collaboration hopes to accelerate industrywide compliance with FSMA 204. 

Keeping You Covered on Traceability

To keep you ahead of the curve on traceability and FSMA 204, we'll continue to cover the topic through our eNews coverage, our webinars program, our eMagazine, the Food Safety Matters podcast, and the upcoming 2025 Food Safety Summit.

Keep an eye out for our upcoming coverage on FSMA 204/Traceability in the April/May 2025 issue of our eMagazine, as well as planned webinars on "How to Conduct a Mock Recall and Ensure Traceability" in February 2025 and another on "FSMA 204 Readiness" in April 2025. And in case you missed it, the 2024 Food Safety Summit workshop on "Traceability Best Practice Sharing," featuring a panel of government and industry experts, is still available to watch on-demand here.

As always, if there's anything specific you'd like us to cover related to traceability and FSMA 204, please feel free to drop me a note at blumea@bnpmedia.com. I always look forward to hearing from you!

References

1. Food Safety Magazine Editorial Team. "FDA Publishes FSMA Pre-Harvest Agricultural Water Final Rule." Food Safety Magazine. May 2, 2024. https://www.food-safety.com/articles/9449-fda-publishes-fsma-preharvest-agricultural-water-final-rule.
2. U.S. Food and Drug Administration (FDA). FSMA Final Rule on Pre-Harvest Agricultural Water. Current as of May 8, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-pre-harvest-agricultural-water.
3. International Fresh Produce Association (IFPA). "FDA Issues Final Ag Water Rule, IFPA Reacts." May 6, 2024. https://www.freshproduce.com/who-we-are/press-center/2024/fda-issues-final-ag-water-rule-ifpa-reacts/.
4. Food Safety Magazine. "Ep. 125. Dr. Conrad Choiniere: Moving 'Closer to Zero' Through Collaboration." Food Safety Matters Podcast. August 23, 2022. https://www.food-safety.com/articles/7959-ep-125-dr-conrad-choiniere-moving-closer-to-zero-through-collaboration.
5. FDA. "Agricultural Water Assessment Builder." https://agwaterassessment.fda.gov/.
6. FDA. "Annual Agricultural Water Assessments and Risk-Based Outcomes." https://www.fda.gov/media/178219/download?attachment.