The rule aims to establish additional traceability recordkeeping requirements for companies that manufacture, process, pack or hold high-risk foods the FDA has designated for inclusion on the Food Traceability List. Specifically, the rule requires these entities to establish and maintain records containing key data elements associated with different “Critical Tracking Events.” The compliance date is Jan. 20, 2026.
NGA, the national trade association representing the independent supermarket industry, argues that the new traceability rule will disproportionately affect smaller grocers.
“Grocers are a customer’s last touch, and oftentimes the face of our vastly diverse food supply chain, and in turn, [this] makes product recalls an established part of our members’ operations,” said Stephanie Johnson, VP, government relations at Washington D.C.-based NGA. “Having the safest food supply chain in the world is a common goal shared among stakeholders. However, while we appreciate FDA’s efforts, this final rule unfortunately does not take an approach that provides flexibility for smaller operators as intended by Congress.”
NGA had submitted comments to the FDA on the proposed rule and participated in listening sessions to outline concerns, including the expanded scope and complexity of the proposed rule, the implementation phase-in period, and the requirements to produce a sortable electronic spreadsheet within 24 hours as foods including cheese, eggs, nut butters, some fresh fruits and vegetables, fish, and ready-to-eat deli salads move through the supply chain.
“Smaller retailers will be disproportionately impacted by this final rule, as it will be expensive to implement and require additional labor that many stores cannot spare,” Johnson said.
Additionally, NGA believes that the new rule exceeds the FDA’s statutory authority. FSMA explicitly prohibits case-level tracking and electronic recordkeeping, both of which are included as requirements in this rule.
Arlington, Va.-basedFMI agrees with NGA.
“It is already clear that implementation of the requirements in the rule will demand tremendous investments of time and resources across the entire food industry, and it looks like this rule significantly exceeds the statutory authority, both written and intended, by Congress,” said FMI Chief Public Policy Officer Jennifer Hatcher. “FMI and our members work every day to further strengthen the safety of our food supply and the continued rapid removal of any impacted products. This work needs to be done in the most efficient, consistent manner across all elements of the food supply chain, with the least possible impact on food prices, greatest impact on results and consistency with the intent of the law passed in 2011. Based on our quick review of this incredibly complex rule, it does not accomplish this.”
Hatcher went on to explain that since the proposed rule was released, FMI has continually urged FDA to release a Supplemental Rule rather than moving straight to a final rule, given the volume and complexity of changes that commenters have urged FDA to make. “We believed a Supplemental Rule was a critical step to ensure that a final regulation is consistent with the statutory mandate and realistic in terms of the ability of companies of all sizes to comply,” she said.
Both NGA and FMI said that they’re committed to ensuring that consumers have 100% confidence that the products their members make and sell are safe.
“NGA and independent community grocers across the country are fully committed to working collaboratively with industry partners and government to address ongoing concerns and developing commonsense solutions moving forward,” Johnson said.