US: FDA Submits FSMA 204 Traceability Records Burden to OMB Review

On June 11, 2026, the US Food and Drug Administration (FDA) submitted to the Office of Management and Budget (OMB) a proposed information collection for the additional food traceability recordkeeping required under Section 204 of the FDA Food Safety Modernization Act (FSMA). The notice, published in the Federal Register as 91 FR 35486, requests reinstatement of OMB Control Number 0910-0560 and sets a comment deadline of July 13, 2026.

The submission is a Paperwork Reduction Act (PRA) step, not a new substantive obligation. It quantifies the paperwork burden of the traceability rule FDA finalized on November 21, 2022 (21 CFR Part 1, Subpart S), whose compliance date FDA has already extended to July 20, 2028. For compliance leads, the value of the notice is the updated burden picture it puts on the record: an estimated 23,071,935 annual recordkeeping hours across the Food Traceability List (FTL) supply chain.

What does the OMB submission cover?

The collection bundles two recordkeeping regimes. Subpart J (21 CFR 1.326 through 1.368) carries the older Bioterrorism Act source and recipient records. Subpart S (21 CFR 1.1300 through 1.1465) adds the FSMA 204 requirements: key data elements (KDEs) tied to critical tracking events (CTEs) for foods on the FTL, plus a written traceability plan under section 1.1315. Records must be retained for 2 years and produced to FDA in an electronic, sortable spreadsheet on request.

FDA's revised burden estimate reflects updates to its earlier accounting. The recordkeeping table reports 379,493 recordkeepers maintaining Subpart J records, 212,368 entities establishing a traceability plan, and roughly 2.98 billion total annual records across harvesting, packing, shipping, receiving and transformation activities. The separate reporting burden for petitions and waivers is modest: 20 respondents and 200 total hours.

Who has to maintain FSMA 204 traceability records?

The rule reaches any person who manufactures, processes, packs, or holds a food on the FTL, including farms, first land-based receivers of seafood, initial packers of raw agricultural commodities, shippers, receivers, and transformers. The FTL covers fresh produce, leafy greens, certain cheeses, eggs, nut butters, and ready-to-eat foods among other categories. Importers of FTL foods are within scope, because the recordkeeping follows the food rather than the establishment's location.

What is the compliance deadline, and has it moved?

The binding compliance date remains July 20, 2028. FDA extended it from the original January 20, 2026 date to give covered entities more time, and this OMB submission does not change it. The PRA process runs in parallel, not on the compliance critical path.

What should food traceability teams do now?

The PRA comment window is effectively closed, so the practical task is implementation against the 2028 deadline. Concretely: confirm which of your SKUs fall on the FTL; build or validate the traceability plan required under section 1.1315; map each CTE (harvesting, cooling, initial packing, first land-based receipt, shipping, receiving, transformation) to the KDEs you must capture; ensure records are sortable and exportable as an electronic spreadsheet within 24 hours of an FDA request; and verify the 2-year retention is enforced across systems and trading partners.

Obsidian's continuous, per-jurisdiction real-time monitoring surfaces this kind of administrative step the moment it publishes, alongside the substantive rule changes that actually move a compliance date.

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Next steps for compliance leads: audit your FTL exposure against the current product list, confirm your 2028 readiness against the KDE and CTE requirements, and brief your supply chain and IT teams on the sortable spreadsheet production obligation. The underlying rule is settled; the work now is execution, and Obsidian tracks each movement of the 2028 deadline as it happens.