FDA Seeks Feedback on Enhanced Food Traceability Record-Keeping Rules
Published Date: 12/9/2025
Notice
Summary
The FDA wants to hear from food businesses about new rules for keeping extra records to track certain foods better. This helps keep food safe and makes it easier to find problems fast. If you’re involved in food production or handling, you have until February 9, 2026, to share your thoughts—no extra costs yet, just a chance to comment!
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
New traceability record rules for food firms
If you manufacture, process, pack, hold, receive, distribute, transport, or import food in the U.S., FDA requires you to establish and maintain records that identify immediate previous sources and immediate subsequent recipients for covered foods. These requirements are in 21 CFR part 1, subparts J and S and are intended to speed up finding contaminated food.
Large estimated aggregate recordkeeping burden
FDA estimates the annual recordkeeping burden for these requirements totals 23,071,935 hours and 2,981,605,187 records across affected entities. The agency reports an overall increase of 4,227,299 hours in its revised estimate.
You must have a written traceability plan
Persons who manufacture, process, pack, or hold foods on FDA's Food Traceability List must create and keep records that demonstrate the creation and establishment of a traceability plan (see Sec. 1.1315). The plan and related records must be maintained for 2 years from the date they were created or obtained.
Specific data elements required by activity
For foods on the Food Traceability List, FDA requires different specific data elements depending on the activity (harvesting/cooling, initial packing, first land-based receiving from vessels, shipping/receiving, transforming). Required fields include things like traceability lot code, product description, quantity, harvest or ship dates, location descriptions, and reference document type and number (see Secs. 1.1325–1.1350 and 1.1340–1.1345).
Route to request exemptions or waivers
You may submit a citizen petition to request modified requirements or exemptions (Sec. 1.1370) or a written request/citizen petition to seek waivers for economic hardship (Secs. 1.1415 and 1.1425). Waiver requests must specify the entity type, show why the requirement creates economic hardship, and explain why the waiver will not significantly impair FDA's ability to trace foods.
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