FDA's Food Traceability Rule requires records, not just labels. Here's what's actually in the regulation — which foods are covered, what you must record at each step, and what the 24-hour spreadsheet request looks like.
Written from the regulation itself, with section citations · Updated July 2026
| TLC ▾ | Product | Qty | CTE | Date | Shipped To |
|---|---|---|---|---|---|
| LOT2607A | Cucumbers 24ct | 52 cases | Init. pack | 07/06 | — |
| LOT2607A | Cucumbers 24ct | 40 cases | Shipping | 07/07 | DC — Riverside |
| LOT2607A | Cucumbers 24ct | 12 cases | Shipping | 07/08 | Wholesale — Fresno |
| LOT2607B | Roma Tomatoes 25lb | 60 cases | Init. pack | 07/07 | — |
| LOT2607B | Roma Tomatoes 25lb | 60 cases | Shipping | 07/08 | DC — Riverside |
Section 204 of the Food Safety Modernization Act directed FDA to require extra recordkeeping for the foods most often tied to outbreaks. The result is the Food Traceability Rule — codified at 21 CFR Part 1, Subpart S — and its core idea is simple: for foods on the Food Traceability List (FTL), everyone who harvests, cools, packs, ships, or receives the food must record specific facts (Key Data Elements) at specific moments (Critical Tracking Events), all tied together by one identifier: the traceability lot code.
When an outbreak investigation happens, those records let FDA follow a specific lot backward to the field and forward to every recipient — in hours instead of weeks. That's also why the rule's teeth are a deadline: records must be available to FDA within 24 hours of a request § 1.1455(c).
On timing: FDA extended the rule's original January 20, 2026 compliance date to July 20, 2028. Retail buyers aren't necessarily waiting, though — several major chains have set their own earlier supplier deadlines. Confirm current dates at fda.gov.
Coverage is by commodity, and the lines are more specific than most summaries let on. "Fresh" excludes previously frozen product, and several major produce categories are not listed at all:
Non-produce FTL items include certain soft cheeses, shell eggs, nut butters, much seafood, and refrigerated deli salads. FDA can update the list, so check the current FTL at fda.gov for your exact commodities.
The rule builds in real relief for small operations § 1.1305. The two that matter most for growers:
The $25,000 farm exemption. A produce farm is fully exempt if its average annual sales of raw agricultural commodities (plus the market value of produce it packs or holds without sale) over the previous 3 years is no more than $25,000, adjusted for inflation from a 2020 baseline, on a rolling basis.
Direct-to-consumer sales. Food produced on a farm and sold or donated directly to a consumer by the farm is outside the rule — farmers markets, CSAs, roadside stands.
There are further partial exemptions (small retail food establishments, foods that receive a kill step, commingled RACs, and more). If you're near a threshold, read § 1.1305 directly or ask FDA — this page is a map, not legal advice.
Everything in Subpart S hangs off one identifier. A traceability lot code (TLC) is "a descriptor, often alphanumeric, used to uniquely identify a traceability lot" § 1.1310. For produce, the TLC must be assigned at initial packing § 1.1320 — the moment a raw agricultural commodity goes into its case is the moment its traceability identity is born.
Two rules follow from that. First, once assigned, the TLC travels: every shipping and receiving record downstream must reference it, and you generally must not assign a new one just for shipping. Second, the records must always be able to point back to the traceability lot code source — the place where the code was assigned — either by full location description or by a reference like an FDA registration number.
If your cases already carry PTI labels, you've met this identifier halfway: the lot number encoded as AI (10) in the case's GS1-128 barcode is the natural TLC, assigned at packing, printed on every case, and scanned at every dock. That's the deliberate overlap between the industry standard and the regulation — more in Where PTI labels fit.
These are the records the rule actually lists for the events a produce operation owns. Every record set ends the same way: the reference document type and number — the BOL, invoice, or packout sheet the record lives on.
The harvester must also provide this information — plus business name and phone — to the initial packer, directly or through the supply chain.
Also must be provided forward to the initial packer.
A simplified set applies when you receive product from an exempt person — § 1.1330(c).
You must also send items 1–7 to your recipient (in electronic, paper, or written form) with every shipped traceability lot — the packout sheet is a legal handoff, not just a courtesy. Shipping records don't apply to pre-packing movements of a RAC.
Receiving § 1.1345 and transformation § 1.1350 have their own KDE sets, but those events belong mostly to your buyers — distributors, processors, and retailers — not to the grower-packer side of the chain.
Beyond per-lot records, covered operations must keep a written traceability plan § 1.1315 describing: how you keep the required records (format and location), how you identify FTL foods you handle, how you assign traceability lot codes, and a point of contact for questions. If you grow FTL produce, the plan must include a farm map showing the location and name of each field or growing area — including geographic coordinates.
When you update the plan, the previous version must be retained for 2 years. It's a living document, not a one-time filing — and it's the piece of FSMA 204 that no software can fully do for you, because it describes your operation.
All required records must be made available to FDA within 24 hours of a request (or a longer time FDA agrees to), along with whatever is needed to understand them — code glossaries, abbreviations, how your records map to the rule § 1.1455(c)(1).
And when it matters most — preventing or mitigating an outbreak, or assisting a recall — FDA can require the relevant traceability information as an electronic sortable spreadsheet, also within 24 hours § 1.1455(c)(3). That spreadsheet is the rule's whole design made visible: lot codes down one column, events and quantities across the rest, sortable by the lot under investigation. Farms averaging no more than $250,000 in annual sales (and small retailers/restaurants) may provide the information in another form.
Practical details that matter: records may be kept as paper, electronic records, or true copies; you can have another entity keep records on your behalf — like your software — as long as they're retrievable within 24 hours; offsite and cloud storage count as onsite if accessible from your location; and records must be retained for 2 years § 1.1455(a)–(d). You also don't need to duplicate what existing business records already capture — BOLs, invoices, and packout sheets can carry KDEs if they contain the required information.
The Produce Traceability Initiative and FSMA 204 grew up to fit together. A PTI case label puts the GTIN and lot number on every case in a GS1-128 barcode; FSMA 204 needs a traceability lot code on every record. Use the PTI lot as your TLC and the identifier the regulation revolves around is already printed on your product, scanned at every dock, and carried on your SSCC pallet labels alongside the quantities your shipping records need.
But be clear-eyed about the boundary: no label makes you FSMA 204 compliant. Compliance is records — KDEs kept and linked lot by lot, a written traceability plan, and the ability to hand FDA a sortable spreadsheet in 24 hours. What good labeling does is guarantee the identifiers in those records are real, consistent, and machine-readable end to end, instead of retyped and drifting.
PTI Label Studio handles the labeling half today: GTINs with correct check digits, lot numbers, pack dates, scan-verified GS1-128, and pallet tags that carry case quantities. Every label generated is logged with its GTIN, lot, and date — the same data spine an FSMA record set is built on.
Section 204 of the Food Safety Modernization Act and the Food Traceability Rule FDA issued under it (21 CFR Part 1, Subpart S). It requires traceability records — Key Data Elements captured at Critical Tracking Events — for foods on the Food Traceability List, available to FDA within 24 hours of a request.
Fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, and all fresh-cut produce are on the list. Avocados, citrus, bananas, pineapple, and whole-head cabbage are not. Check FDA's current FTL for your exact commodities.
The TLC is the identifier assigned at initial packing that every downstream record must reference. Yes — for PTI-labeled produce, the lot number in your case label's (10) field is the natural TLC, and using it means the code on your records matches the code scanned on your cases.
When needed for an outbreak or recall, FDA can require your relevant traceability information as an electronic sortable spreadsheet within 24 hours (§ 1.1455(c)(3)). Farms averaging no more than $250,000 in annual sales may provide it in another form.
Produce farms averaging no more than $25,000/year (3-year rolling, inflation-adjusted) are fully exempt, and direct-to-consumer farm sales are outside the rule. Other partial exemptions exist — see 21 CFR 1.1305.
FDA extended the original January 20, 2026 compliance date to July 20, 2028. Some retail buyers have set earlier supplier deadlines of their own, so your effective date may come from your customer, not FDA. Confirm current dates at fda.gov.
No software or label does — compliance is your records and traceability plan. PTI Label Studio produces the compliant case and pallet labels that carry your GTINs and lot codes, which are the identifiers your FSMA records are built around.
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