FDA Engages Stakeholders on FSMA 204 Implementation With Questions About Lot-Level Traceability
In April, the U.S. Food and Drug Administration (FDA) announced it would be hosting virtual town hall meetings on the implementation of the Food Traceability Rule, with a particular focus on challenges and opportunities related to the rule’s lot-level tracking requirements.
Ahead of the first of the two meetings, which will take place on June 15, FDA has released a discussion paper offering context and questions to help shape the agency’s engagements with stakeholders.
Topics listed in the discussion paper include:
- Reasonable range of traceability lot codes (TLCs) for distributors shipping to retailers
- Inferred TLCs with flexibility for distributors shipping to retailers
- Maintaining key data elements (KDEs) “eaches,” described as food items that are no longer part of a case
- Maintaining KDEs for returns and reclamations
- Maintaining KDEs for intracompany shipments
- Challenges around food waste recovery
- Shipments for retailers transforming Food Traceability List (FTL) foods and sending them to other retailers
- Data standardization.
FDA strongly encourages those attending the June 15 meeting to read the discussion paper ahead of time. The agency is also inviting stakeholders to provide feedback on the discussion paper on the Federal Register.
Update, July 7, 2026: FDA published a recording of the June 15 meeting on the meeting page.
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