FDA to Extend Compliance Date for Food Traceability Rule

Pickles — Image by Lukáš Jančička from Pixabay

The U.S. Food and Drug Administration has announced its intention to extend the compliance date for the Food Traceability Rule by 30 months.

The agency says intends to extend the compliance date using appropriate procedures at a later time, including publishing a proposed rule in the Federal Register. The compliance date extension does not amend, nor does the FDA intend to amend, the requirements of the final rule. Instead, the compliance date extension affords covered entities additional time to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements — ultimately providing FDA and consumers with greater transparency and food safety.

The final rule establishes additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for companies that manufacture, process, pack or hold foods on the Food Traceability List. The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Therefore, to achieve the full public health benefits of the final rule, all covered entities must be in compliance.

Even those few entities that are well positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA intends to allow industry additional time, across all regulated sectors, to fully implement the final rule’s requirements.

The FDA intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools and other resources to assist industry with implementation.

The final rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act.

Angela Fernandez, senior vice president of market development for GS1 US, says the not-for-profit standards organization appreciates the FDA's acknowledgement that some food industry entities need more time to comply.

"GS1 US will continue our important work of collaborating with all of industry to achieve deeper levels of traceability and supply chain visibility with the goal of creating a safer food supply chain for consumers in advance of the Final Rule’s new deadline," Fernandez says. "This extension for industry compliance allows GS1 US and our members more time to work toward changes needed and working through pilot efforts to help them meet the requirements of the rule by leveraging GS1 Standards for interoperability and efficient sharing of data up and down the supply chain."