Earlier today, FDA issued a proposed rule that would extend the compliance date of the Food Traceability Rule by 30 months, i.e., until July 20, 2028. The Food Traceability Rule, which is one of the core rules FDA was required to issue under the Food Safety Modernization Act (FSMA), will impose additional traceability recordkeeping requirements on persons who manufacture, process, pack, or hold foods that appear on FDA’s Food Traceability List. FDA published the final Food Traceability Rule on November 15, 2022, with an original compliance date of January 20, 2026.
In the preamble to the proposed rule, FDA noted that “entities from across the supply chain have voiced strong concerns” with the rule’s initial implementation timeframe. In particular, FDA noted that stakeholders have expressed concerns regarding:
- The interoperability of data systems throughout the supply chain;
- The volume of data entities will be required to receive, maintain, and transmit under the rule;
- The fact that companies do not routinely share many of the rule’s required data elements under current practice; and
- The time it will take to develop, pilot, and implement technological solutions.
FDA also acknowledged that, even if some entities in the supply chain are prepared to come into compliance with the rule by January 20, 2026, the inability of other entities to comply by that date would “substantially diminish the rule’s effectiveness,” given that the rule requires that each entity in the supply chain pass required records down to the next entity in the supply chain. For these same reasons, FDA has tentatively concluded that it is appropriate to delay the compliance date for all entities in the supply chain, rather than implement a partial or phased approach to compliance.
FDA will accept public comments on the proposed rule for 30 days. FDA noted that this extension does not amend the Food Traceability Rule’s requirements and that the agency does not otherwise intend to amend the rule. That said, stakeholders may consider using this comment period to identify additional steps FDA could take to address implementation challenges associated with the rule.
In addition to releasing the proposed rule, FDA updated its Food Traceability Rule FAQ webpage to include more than 20 new FAQs, including on the following key topics:
- Does FDA expect 100% accuracy of key data elements (KDEs)?
- How does FDA see interoperability as contributing to improved traceability?
- What is an acceptable record in which to document a kill step?
- Do I need to keep records for all foods I handle, or only for foods on the Food Traceability List?
- If I keep records in multiple locations, as opposed to a single set of records, how do I provide the information to FDA?
- Is the traceability lot code (TLC) source the location where the TLC was determined, or the place where the food was physically located when it became associated with the TLC?
- Is it acceptable to use a Global Location Number (GLN) as the “location description” key data element?
FDA also updated its Food Traceability Rule webpage to include other new resources, including:
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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