SUPPLEMENTARY INFORMATION:

I. Background

The FDA final rule, “Requirements for Additional Traceability Records for Certain Foods” (87 FR 70910, November 21, 2022) (Food Traceability Rule), establishes enhanced recordkeeping requirements for those who manufacture, process, pack, or hold foods on FDA's Food Traceability List (FTL). The Food Traceability Rule requires lot-level tracking for foods on the FTL. Businesses that perform specific activities are required to assign unique codes, known as Traceability Lot Codes (TLCs), that must be passed along unchanged (unless the food is transformed) as the food moves through the supply chain. Entities that handle foods on the FTL are required to record Key Data Elements (KDEs), such as the TLC, when they perform specific Critical Tracking Events (CTEs), such as initial packing, transformation, and shipping. Lot-level tracking enables rapid tracing of contaminated foods during recall events, allowing FDA to identify the source of the food faster, narrowing the scope of recalls and removing affected product from the supply chain more quickly, resulting in fewer foodborne illnesses and deaths.

The original compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule was January 20, 2026. FDA proposed to extend the compliance date for the rule by 30 months to July 20, 2028 (90 FR 38084, August 7, 2025). Subsequently, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 (Pub. L. 119-37) (Continuing Appropriations Act) directed FDA not to enforce the Food Traceability Rule prior to that same date of July 20, 2028. FDA intends to comply with this Congressional directive.

Section 780 of the Continuing Appropriations Act also directed FDA to engage quarterly with regulated entities to identify and implement, as appropriate, additional flexibilities for satisfying the Food Traceability Rule's lot-level tracking requirement. The public meeting announced in this notice is part of a series of engagements being held to fulfill that directive. As part of the same series of engagements, we previously held a public meeting on June 15, 2026. Prior to that public meeting, we published a discussion paper titled “Identifying Additional Flexibilities for Satisfying the Food Traceability Rule's Lot-Level Tracking Requirement” ( www.regulations.gov/​document/​FDA-2014-N-0053-1371). We provided an opportunity for stakeholders to submit feedback on the ideas presented in the discussion paper. We received 26 comments on the discussion paper from industry, trade associations, and technology partners. We have provided a high-level summary of those comments below. All comments can be accessed by searching Docket No. FDA-2014-N-0053 on www.regulations.gov.

TLC Flexibilities: Many commenters supported flexibility for identification of TLCs by allowing for a reasonable range of TLCs or inferred TLCs to be used when shipping FTL foods from distribution to retail. With both options, several stakeholders noted the need for these flexibilities to be accompanied by guardrails, including documented operational practices, validation exercises, and an understanding that the reasonable range of TLCs or inferred TLCs be limited to the fewest TLCs possible. However, some commenters expressed concern that a flexibility for TLCs could reduce product-specific traceability and unnecessarily broaden the scope of a recall.

Flexibility for Eaches, Returns, Reclamations, and Food Waste Recovery: There was broad support from stakeholders to provide flexibilities for eaches, returns, and reclamations as these account for a relatively small amount of product that has often been separated from the original case. There was also support for additional clarity on the exemption for donated food to ensure that food waste recovery is not discouraged due to the requirements of the rule.

Intracompany Shipments: Some stakeholders noted continued confusion around the required records for intracompany shipments and requested clarification on these requirements. Some stakeholders also requested flexibility to track incoming and outgoing TLCs with records of internal movements of FTL foods that would be available upon request.

Retail Transformer Shipments: There was broad support from commenters for a simplified, modified recordkeeping framework for retail-kitchen-to-affiliated-store shipments.

Data Standardization: There was strong support among stakeholders for FDA to recognize GS1 as an acceptable data standard for use in identifying shipments of FTL foods. FDA recently posted a FAQ on data standards, which is available at www.fda.gov/​food/​food-safety-modernization-act-fsma/​frequently-asked-questions-fsma-food-traceability-rule#TPTS3.

II. Topics for Discussion at the Public Meeting

The goal of this public meeting is for FDA to hear stakeholder perspectives on lot-level food traceability efforts and implementation challenges facing industry. FDA is interested in learning more about the challenges and potential solutions for satisfying the Food Traceability Rule's lot-level tracking requirements.

Specifically, we are interested in feedback on the potential flexibilities in achieving compliance with the rule that have been identified to date and on the feedback received on the discussion paper in the docket. We encourage those participating in this public meeting to consider the questions posed in the discussion paper, stakeholder responses to these questions submitted to the docket, and any new ideas regarding flexibilities as you develop your ( printed page 64658) remarks for this meeting. We also welcome additional comments or presentation materials to be submitted to the docket for consideration.

III. Participating in the Public Meeting

Registration: Please visit the following website for additional information and to register for the public meeting: www.fda.gov/​news-events/​fda-meetings-conferences-and-workshops.

The virtual public meeting is free and open to the public, but registration is necessary to attend. General registration will remain open until November 5, 2026. Individuals who want to speak during the public comment period must register by October 26, 2026. Same-day registration is not allowed. Instructions for joining the virtual meeting will be provided upon registration.

Requests for Oral Presentations: During online registration you may indicate if you wish to present during the public comment session. We will do our best to accommodate all requests to make public comments. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin and will notify participants in advance by November 4, 2026. All requests to make oral presentations must be received by the close of speaker registration on October 26, 2026. All presentations must be given orally; we cannot accommodate slides or visuals on the virtual platform. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.