In a little over a year, grocers and their suppliers will need to comply with the U.S. Food and Drug Administration’s new food traceability requirements. But several major questions remain, according to a new report.
Grocery industry trade associations have said the rule, which has a compliance date of Jan. 20, 2026, presents the biggest food safety changes that retailers have seen in over a decade. A new report from the Reagan-Udall Foundation for the FDA explores which parts of the rule are confusing to executives that are working to bring their companies into alignment with the rule.
The report is based on three industry roundtables the foundation held this spring with more than two dozen participants, including executives from General Mills, FMI — The Food Industry Association, Subway, the International Fresh Produce Association and United Natural Foods, Inc.
Here are the main compliance challenges participants said they face, according to the report. The Reagan-Udall Foundation for the FDA plans to explore these top issues during a virtual public meeting on the rule on Oct. 7.
Level of labeling for Traceability Lot Codes (TLC)
Firms shipping foods covered by the rule will need to provide TLCs to recipients for each lot of food as well as information on where the food got the code. Participants said they need clarification on the degree of labeling and tracing activity required, and they want better definitions of what information TLCs need to have, according to the report.
“For example, some participants believe that labeling and tracking at the case-level is essential to generate the required information, although case-level labeling and tracking is not explicitly required,” the report noted.
Warehouse management systems
Warehouse management systems vary significantly across the industry and “most are likely not capable of capturing all [required data points] without significant upgrades or overall system replacement,” the report noted.
Given the labor intensity of labeling and scanning every case of food and the fact that a pallet can have mixed lots of the same product, participants wondered if “most likely” lot codes or probability calculations would be acceptable.
Reporting metrics
Participants said they are confused about when they need to submit a completed spreadsheet template to provide information requested by the FDA.
“Participants suggested making the instructional portion of the spreadsheet template more accessible and providing a sample ‘completed template’ to demonstrate expectations for each sector of the supply chain,” the report said.
The report continued: “Participants also requested the spreadsheet be tested with real-world or simulated data, through the supply chain from farm to restaurant or retailer, to identify any adjustments that might improve its adoption and usability.”
FDA investigation process
If food-borne illness outbreaks happen, participants said they have questions about the FDA investigation, such as what happens when multiple lot codes are submitted. They also raised concerns about what to do about “damaged, unreadable, improperly encoded, or lost labels,” which could lead to unreliable reporting.
Next steps
Since the rule’s release in November 2022, industry pilot programs have aimed to test current systems and identify changes, but “most” have focused on only one food product or category, the report said.
Along with urging for more pilots, participants said they would like templates for running pilots, spaces to share learnings and tailored tests for small, medium and large businesses.
Additionally, participants said they like to explore public-private partnerships where cross-sector companies work with state regulators and public health agencies. Such partnerships could help support implementation; create consistency around data structure, requirements, timing and standards; provide a space for pilot results; and collect information to share with the FDA.
The FDA said it is willing to participate in a public-private partnership, the report noted.
While it’s unclear how feasible this proposal is, some participants stated support for staggering the rule’s compliance date by sector or by company size, the report said.
“As each sector of the supply chain (the purchaser) relies on information provided by the prior sector participant (their supplier), sector by sector implementation could start at the beginning of the supply chain and progress through to retail and create a roadmap to compliance,” the report said.