FSMA 204 Compliance Guide
The FDA food traceability rule, in plain English.
If you grow, pack, ship, or sell food on the FDA's Food Traceability List, FSMA 204 applies to you. Here's what it requires, whether you're a 50-acre farm or a national distributor.No technical background needed. No jargon.
- 24 hours to respond to an FDA request
- Applies to all foods on the FTL
- Earliest enforcement date under current public posture: July 20, 2028
What is FSMA 204?
The FDA's Food Safety Modernization Act Section 204 (commonly called “FSMA 204” or the “Food Traceability Rule”) requires anyone who grows, receives, ships, or transforms certain high-risk foods to keep detailed traceability records.
The goal is simple: when a foodborne illness outbreak happens, FDA can request your traceability records and you must produce a sortable electronic spreadsheet within 24 hours. Before this rule, that process could take weeks.
The rule was finalized in 2022. The original compliance date was January 20, 2026. Congress directed FDA not to enforce the rule before July 20, 2028. The requirements themselves have not changed.
The deadline moved. The rule didn't.
Congress directed FDA not to enforce before July 2028, but major retailers have published supplier traceability programs that pre-date the federal enforcement date. If you sell to a major retailer, check your supplier portal: your effective deadline may already have passed.
The Food Traceability List (FTL)
Are your products covered?
FDA's Food Traceability List identifies covered foods and certain foods containing listed ingredients in the same form. Examples are below; verify each product against FDA's current FTL and applicable exemptions.
Leafy Greens
Romaine, spinach, spring mix, kale
Fruits
Tomatoes, peppers, melons, berries
Fresh Herbs
Cilantro, basil, parsley
Seafood
Finfish, crustaceans, mollusks
Shell Eggs
Shell eggs (per FDA FTL definition)
Nut Butters
Peanut butter, almond butter
Cheeses
Cheeses other than hard cheese (per FTL)
Ready-to-Eat Deli Salads
RTE deli salads (per FTL)
Not sure if your specific products are on the list?
What the FDA requires
Seven events you need to track.
FSMA 204 calls these “Critical Tracking Events” (CTEs). Each one has specific data points (called KDEs) you must record. Here's what they mean in practice:
Harvesting
Farms & growers
Record when and where you harvested, the lot code, and what product it is.
Cooling
Farms & coolers
Record when the product was cooled after harvest, where, and under what lot code.
Initial Packing
Packhouses
Record what was packed, when, the lot code, and the quantity.
First Land-Based Receiving
Receivers of seafood from a fishing vessel
Under §1.1335, record when seafood was received from a fishing vessel, the lot code, the harvest and landing location, and the receiving facility. This is distinct from generic imported-food entry.
Shipping
Anyone sending product
Record who shipped, who received, the lot code, carrier, and date.
Receiving
Anyone receiving product
Record what arrived, from where, the lot code, quantity, and date.
Transformation
Processors
Record what went in (input lots) and what came out (new lot), with dates and location.
Which events apply to you?
Most farms need to record harvesting, cooling, packing, and shipping. Distributors typically handle receiving and shipping. Processors handle receiving and transformation. Importers must also record first land-based receiving. You only record the events that happen at your facility.
The 24-hour rule
When the FDA calls, you have one day.
During a recall or outbreak investigation, the FDA can request your traceability records. You must provide them in an electronic, sortable format (like a spreadsheet) within 24 hours.
Without a system
Dig through paper records, spreadsheets across multiple computers, call suppliers for missing info. Typical response: 3-5 days, incomplete.
With RegEngine
Click “Export” in your dashboard. RegEngine produces a sortable electronic spreadsheet structured to FDA's §1.1455 format, populated from your uploaded lot codes, dates, and locations. Done in minutes.
Getting started
How RegEngine supports your FSMA 204 program.
No IT department required. No six-figure software contract. If you can fill out a spreadsheet, you can use RegEngine.
Check your products
Use our free FTL Checker to see which of your products are on the FDA Food Traceability List. Takes 30 seconds.
FTL CheckerUpload your data
Download our CSV or Excel template, fill in your lot codes, locations, and dates. Upload it to RegEngine. No code, no API, just a spreadsheet.
Download TemplatesRegEngine maps your events
We map your data to the 7 Critical Tracking Events defined in the FSMA 204 rule: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving, and transformation. You only record the events that occur at your operation. The dashboard shows what’s covered and what’s missing.
Be ready when they ask
When the FDA or a retailer requests traceability records, RegEngine produces a sortable electronic spreadsheet structured to FDA's §1.1455 format, populated from the lot codes, dates, and locations you've uploaded. Compliance remains your operation's legal responsibility.
Common questions
I’m a small farm. Does this really apply to me?
If you grow, harvest, cool, pack, or ship any food on the FDA Food Traceability List, yes. There are limited exemptions for farms that sell directly to consumers, but if you sell to a distributor, retailer, or restaurant, you’re likely covered.
I don’t have a developer or IT person. Can I still use RegEngine?
Yes. You can upload your data using our CSV or Excel templates, with no code required. Download the template, fill in your lot codes and dates, and upload. RegEngine handles the rest.
What if I already track this in spreadsheets?
That’s a great start. The challenge is that the FDA requires a specific format and the ability to trace lots forward and backward through your supply chain. RegEngine takes your existing data and organizes it into the structure the FDA expects.
How is this different from what Walmart already asks for?
Major retailers have been requiring traceability data ahead of the FDA deadline. If you already supply traceability data to a retailer, you’re partially prepared. RegEngine helps you produce records structured to meet retailer schemas and FDA’s §1.1455 sortable-spreadsheet format from one system.
What happens if I’m not compliant by July 2028?
FDA enforcement under §1.1455 focuses on producing the required records on request. Beyond direct enforcement, major retailers may drop non-compliant suppliers. The bigger risk for most farms is losing a key retail customer over missing traceability data.
How much does this cost?
We have plans designed for small farms and growers. Start with a free readiness assessment to see where you stand, then we’ll recommend the right plan.
Earliest FSMA 204 Enforcement Date: July 20, 2028
Don't wait for the deadline.
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