How quickly must traceability records be given to the FDA?

Within 24 hours of a request, or within a reasonable time the FDA has agreed to, as an electronic sortable spreadsheet containing the relevant traceability information, when the FDA needs it during an outbreak, a recall or another threat to public health. Some entities are exempt from the spreadsheet requirement.

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Requirements for Additional Traceability Records for Certain Foods

The Food Traceability rule, 21 CFR part 1 subpart S, requires anyone who manufactures, processes, packs or holds a food on the FDA's Food Traceability List to keep records of key data elements at defined critical tracking events and to produce them, as a sortable spreadsheet, within 24 hours of an FDA request.

What it is: FSMA final rule
Where it lives: 21 CFR part 1, subpart S
Final rule: November 2022
Docket: FDA-2014-N-0053
Published by: U.S. Food and Drug Administration

Who it covers

Persons who manufacture, process, pack or hold foods on the Food Traceability List, domestic and foreign, wherever they sit in the chain from farm to table. The list is the FDA's, drawn from a risk-ranking model, and it is the list rather than the rule that decides whether a given product is in scope: the FDA's own worked supply-chain examples for the rule are cheese, deli salad, sprouts, aquacultured tilapia, canned tomatoes, canned salmon, imported mangos, shell eggs and fresh produce for meal kits, which is the range of the list.

The rule implements section 204(d) of FSMA and is the part of the FDA's New Era of Smarter Food Safety blueprint with the most direct effect on what a supplier has to record.

What it requires

Records of key data elements at seven critical tracking events: harvesting, cooling before initial packing, initial packing of a raw agricultural commodity, first land-based receiving of a food from a fishing vessel, shipping, receiving, and transformation. Which elements are required depends on the event, and every one has to be linked to a traceability lot code assigned when the food is initially packed, first received on land or transformed.

A traceability plan, describing how the records are kept and where, how foods on the list are identified, how lot codes are assigned, and who to contact. And the ability to hand the FDA an electronic sortable spreadsheet of the relevant records within 24 hours of a request, or within a reasonable time the FDA has agreed, when it is investigating an outbreak, a recall or another threat to public health.

The rule is written so that data passes between trading partners: a receiver's record has to be able to name the shipper's lot code, which is why the FDA has argued for a single compliance date for the whole chain rather than a staggered one.

In the FDA’s words

“The original compliance date for all persons subject to the recordkeeping requirements of the Food Traceability Rule was Tuesday, January 20, 2026. The FDA proposed to extend the compliance date for the rule by 30 months to July 20, 2028.”

U.S. Food and Drug Administration, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, updated 2026-07-24. Read 2026-09-16.

Two dates, both real, and a plan built against a third date made of parts of each would be wrong. Congress has since directed the FDA not to enforce before the later one.

“The Critical Tracking Events in the final rule are harvesting; cooling (before initial packing); initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel; first land-based receiving of a food obtained from a fishing vessel; shipping; receiving; and transformation of the food.”

U.S. Food and Drug Administration, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, updated 2026-07-24. Read 2026-09-16.

Seven events. Which key data elements a record needs depends on which of these it is recording.

“Unless exempt from this requirement, an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.”

U.S. Food and Drug Administration, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, updated 2026-07-24. Read 2026-09-16.

Twenty-four hours, as a spreadsheet. Paper records are permitted, but they have to be turned into one inside that window.

Compliance dates

Who	Date
All persons subject to the rule: the original compliance date	January 20, 2026
Proposed extension of 30 months, and the date before which Congress has directed the FDA not to enforce	July 20, 2028

Two dates, and both are real. January 20, 2026 is the date in the rule as published. The FDA proposed extending it by 30 months to July 20, 2028, and the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 then directed the FDA not to enforce the rule before that same date. The FDA has said it will comply with the directive. In June 2026 it held a public meeting on flexibilities for the lot-level tracking requirement, so the requirements themselves may still move; read the FDA's page before planning against either date.

The dates are the FDA’s, as stated on FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, updated 2026-07-24, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.

Exemptions

The full and partial exemptions are listed in section 1.1305 and turn on the size of the business, the kind of establishment and what happens to the food. Very small producers, farms selling directly to consumers, food that receives a kill step with records to prove it, and certain retail and food service situations are among them. The FDA publishes a yes-or-no tool for working out whether one applies, and can modify or exempt a food or entity type where the requirements are not needed to protect public health.

Where it is in 21 CFR

The rule is codified at 21 CFR part 1, subpart S, General Enforcement Regulations. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.

What goes wrong in practice

A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.

Questions

When is the FSMA Food Traceability rule compliance date?: The rule as published set January 20, 2026 for everyone subject to it. The FDA proposed a 30-month extension to July 20, 2028, and Congress has directed the FDA not to enforce the rule before that date, which the FDA has said it will comply with. Both dates are the FDA's; check its Food Traceability rule page before planning against either.
What are the critical tracking events in the Food Traceability rule?: Harvesting; cooling before initial packing; initial packing of a raw agricultural commodity other than a food from a fishing vessel; first land-based receiving of a food from a fishing vessel; shipping; receiving; and transformation. Each event has its own set of key data elements that must be recorded and linked to a traceability lot code.
How quickly must traceability records be given to the FDA?: Within 24 hours of a request, or within a reasonable time the FDA has agreed to, as an electronic sortable spreadsheet containing the relevant traceability information, when the FDA needs it during an outbreak, a recall or another threat to public health. Some entities are exempt from the spreadsheet requirement.

The other FSMA rules

FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.

An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.