With less than a year and a half until compliance with the Traceability Rule (FSMA 204) is due on January 20, 2026, a number of questions and concerns remain about its implementation and industry impact.
To create a forum for industry discussion, the FDA worked with the Reagan-Udall Foundation to host a three-part series of virtual, invitation-based roundtable conversations with firms who are actively working on implementation. The roundtables, which included a diverse representation of commodity types, firm sizes, and roles in the supply chain, were intended to gain insight into industry perspectives on implementation, challenges, and solutions. Because companies may need to implement new systems and processes to comply with the rule, the roundtables were intended to facilitate cross-sector dialogue, provide opportunities for shared learning, and discuss solutions related to the concerns.
It was determined to be important to start with small group discussions as the rule impacts each step of the supply chain for certain commodities and requires sequential sharing of information. In early September a Top-Line Learnings Summary report on the industry roundtable series was published, listing seven key themes that were discussed.
Of particular interest to TAG was the participants’ interest in the creation of a well-organized public-private partnership that included cross-sector companies of all sizes along with government regulators and public health agencies. Noting that such an organization could facilitate collaboration to support implementation; help build consistency on data structure, requirements, timing, and standards; provide a platform to compare pilot learnings; and aggregate implementation challenges to share with FDA, the participants could have been citing the playbook of the Partnership for Food Traceability (PFT), of which TAG was a co-founder.
With a focus on defining consensus business and functional requirements for traceability, PFT is a forum for the exchange, gathering, and use of traceability data among supply chain partners to deliver a common vision for traceability across sectors, industries, associations, and consortia. Intended to provide a forum for technical implementation discussions, the group 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 the industry can successfully migrate to enhanced traceability. The organization will also identify additional pilot needs and coordinate public-private engagement in future pilots and develop open-source resources and materials.
FDA has agreed to participate in the PFT public-private partnership, bringing regulatory insights as the members work toward solutions. For more information and membership application, visit PFTraceability.org.
In addition to deeming a public-private partnership to be of significant value, the roundtable participants found concerns and factors in effective Traceability Rule implementation to be:
- Awareness. The low awareness of the rule and its requirements (especially among certain sectors, small and medium-sized suppliers, foreign suppliers, non-chain restaurants, and companies not in a trade association) is of concern. The new requirements may be the first instance some supply chain participants are required to provide information to the FDA and many may not maintain the required level of data. There also are varying interpretations of the rule, causing potential compliance questions for both industry and regulators.
- Traceability Lot Code (TLC) & Labeling. Concerns were raised about the level of labeling and tracing activity necessary to generate the required information. Thus, there is a need to better define the information needed for TLCs, the intersection of lot-level and case-level tracking, and best practices for capturing and storing accurate details.
- Warehouse Management System Capability. Distributors often carry thousands of different Food Traceability List (FTL) items, which creates significant complexity and requires a flexible warehouse management system. But with much of the industry interpreting the rule to mean that every case of food must be labeled and scanned, there are grave concerns as most are likely not capable of capturing all rule-required data points without significant upgrades or system replacement.
- Technology. Various technology systems may support compliance with the rule, but questions remain around realistic metrics, opportunities for data/technology standardization, navigating various levels of technical sophistication (from pen and paper to block chain), and what a successful system and its output look like.
- Pilots. Although many pilot programs have been conducted by industry to test current systems and identify necessary changes, most have been conducted independently and focused on a single food product or category. Integrated pilots scaled beyond a solitary product or facility could be helpful, as well as those that test the new regulatory requirements down the full supply chain and to FDA, to assess the usability of the information in foodborne illness investigations.
- Implementation Schedule. Although FDA determined the most effective and efficient way to implement the rule is to have all be compliant at the same time, participants suggested that a staggered implementation schedule by sector or company size might offer greater efficiency and compliance and capitalize on learnings. Sector-by-sector implementation could start at the beginning of the supply chain and progress through to retail and create a roadmap to compliance.
Moving forward, FDA will continue to work with industry and solicit feedback through meetings, comments, its PFT partnership, and other public forums, and will post regular updates and resources as the compliance date approaches. Keep an eye on this space for updated information on both FDA works and that of PFT.
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