The U.S. Food and Drug Administration (FDA) on Wednesday issued its final rule on Requirements for Additional Traceability Records for Certain Foods, which has grocery industry associations expressing concerns regarding the ruling.
The final rule is designed to provide a means for additional traceability of high-risk foods through recordkeeping requirements from companies who manufacture, process, pack or hold foods the FDA has designated for inclusion on the Food Traceability List (FTL).
But FMI – The Food Industry Association and the National Grocers Association (NGA) this week voiced their concerns about the expanded scope of the final food traceability rule.
The NGA, which represents independent supermarkets, said the rule will disproportionately impact smaller grocers.
“Grocers are a customer’s last touch, and often times the face of our vastly diverse food supply chain, and in turn, makes product recalls an established part of our members operations,” said Stephanie Johnson, NGA vice president of government relations, in a statement. “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 requirements of those subject to the rule 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 added.
The compliance date for the new recordkeeping requirements is Jan. 20, 2026.
“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 in a statement. “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."
Both associations agree the new rule exceeds the FDA’s statutory authority.
“We will analyze the 597-page final rule on traceability released today to understand the range of its impact on our member companies,” Hatcher added. “Since the proposed rule was released, we have continually urged FDA to release a Supplemental Rule rather than moving straight to a final rule given the volume and complexity of changes commenters 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.”
Both associations expressed their ongoing full commitment to support and work to protect public health through appropriate product tracing and recordkeeping practices for high-risk foods.