FSMA 204FDA Food Safety Modernization Act, Section 204
FSMA 204 is the FDA Food Traceability Rule (21 CFR Part 1, Subpart S). Firms that manufacture, process, pack or hold foods on the Food Traceability List keep Key Data Elements for defined Critical Tracking Events, keep a traceability plan, and provide records to FDA within 24 hours of a request (or a reasonable time FDA agrees to).
Read the full summary
FDA has said it will not enforce the rule before July 20, 2028.
On this page · 8 sections
How does FSMA 204 apply to your shop floor?
Pick your industry and scale — Ask V5 rewrites the definition in your context, gives a worked example, and shows what V5 does on day one.
01What FSMA 204 is
Section 204 of the FDA Food Safety Modernization Act told FDA to designate foods that need additional traceability records. FDA's answer is the Food Traceability Rule, codified at 21 CFR Part 1, Subpart S, and the Food Traceability List (FTL) that says which foods it covers. The aim, in FDA's words, is faster identification and rapid removal of potentially contaminated food from the market.
It is a US federal recordkeeping rule. It does not set food-safety limits, require a particular software system, or require public reporting. It requires that certain records exist, are linked to a traceability lot, and can be produced quickly when FDA asks.
- Mandatory law (if you are in scope): the rule itself.
- Industry practice: GS1 identifiers, EPCIS event formats and supplier data-sharing agreements are common ways to meet it, but the rule does not mandate them.
- V5 behaviour: described separately below, and never a substitute for your own applicability assessment.
02Who it applies to and when
The rule applies to persons who manufacture, process, pack or hold foods on the FTL. It also applies to foods that contain a listed food as an ingredient, provided the listed food stays in the same form (for example, fresh) as it appears on the list. It covers domestic and foreign firms producing food for US consumption.
Full and partial exemptions exist and are listed in § 1.1305; FDA also has a process to modify requirements or grant exemptions for a food or type of entity (§§ 1.1360–1.1400). Whether you are in scope depends on your actual foods and activities, so check the FTL and the exemptions before designing anything.
03The seven Critical Tracking Events
Records are tied to Critical Tracking Events (§§ 1.1325–1.1350). Which Key Data Elements you keep depends on which event you perform.
| CTE | What it means (FDA summary) |
|---|---|
| Harvesting | Farm activities that remove raw agricultural commodities from where they are grown or raised and prepare them for use as food. |
| Cooling | Active temperature reduction of a RAC before initial packing (hydrocooling, icing other than seafood, forced air, vacuum cooling or similar). |
| Initial packing | Packing a RAC, other than food from a fishing vessel, for the first time. |
| First land-based receiving | Taking possession on land of food directly from a fishing vessel for the first time. |
| Shipping | Arranging transport of food from one location to another, including intracompany moves between street addresses; excludes sales direct to consumers and donations of surplus food. |
| Receiving | Receipt by someone other than a consumer after transport, including intracompany receipts. |
| Transformation | Manufacturing/processing or changing a food (e.g. commingling, repacking, relabeling) or its packaging, when the output is an FTL food. |
04Traceability lot codes and the traceability plan
A traceability lot code (TLC) uniquely identifies a traceability lot within the records of the firm that assigned it. You assign a TLC when you initially pack a RAC (other than fishing-vessel food), perform first land-based receiving, or transform a food. If you receive an FTL food from an exempt entity and no TLC exists, you assign one (unless you are a retail food establishment or restaurant). You must not create a new TLC for other activities such as shipping. Every CTE record carries the TLC.
Under § 1.1315 you keep a traceability plan describing:
- how you maintain the required records, including their format and location;
- how you identify FTL foods you handle;
- how you assign TLCs, if applicable;
- a point of contact for questions about the plan and records;
- for growers (other than eggs) a farm map with field names and geographic coordinates, or for aquaculture a map of containers.
05Record format and the 24-hour request
Under § 1.1455, records may be original paper or electronic records, or true copies, and must be legible and protected from deterioration or loss. Electronic records may include valid, working links to the required information.
All required records, plus anything needed to understand them, must be made available to FDA within 24 hours of a request, or within a reasonable time FDA agrees to. Unless exempt, when it is necessary to help FDA during an outbreak, recall or other public-health threat, you must also provide an electronic sortable spreadsheet of the relevant traceability information within the same window.
06Worked example: a fresh-cut salad processor
Illustrative only. A processor receives cut-ready leafy greens (assume the greens are on the FTL) and makes bagged salad.
- Receiving: record the incoming TLC from the supplier with the receiving KDEs for that event.
- Transformation: washing, cutting and mixing creates a new FTL output, so assign a new TLC and link it to every input TLC consumed.
- Shipping: ship cases under the transformation TLC; do not assign another one.
- Request drill: from one finished TLC, produce the input TLCs, suppliers and customers as a sortable spreadsheet, and time how long it takes.
The weak point in most real plants is step 2: partial use of input lots, rework and line changeovers are where links get lost.
07Common failure modes and how to test for them
| Failure mode | How to evaluate the control |
|---|---|
| Scope assumed, not checked | Map each SKU's ingredients against the current FTL and § 1.1305 exemptions; record the decision. |
| New TLC created at shipping | Sample shipments and confirm the shipped TLC equals the packing or transformation TLC. |
| Inputs not linked at transformation | Pick finished lots and confirm every consumed input lot appears, including rework. |
| Supplier data missing or late | Check what fraction of receipts arrive with the KDEs you need; agree formats with suppliers. |
| Records exist but cannot be assembled | Run a timed retrieval and spreadsheet build from a random lot, off-hours included. |
| Plan out of date | Confirm the plan's record locations and contact still match reality. |
08Where V5 fits
V5 records lots and traceability with GS1-128 labels as part of receiving, production and shipping, and lists FSMA 204 / EPCIS 2.0 publishing of CTEs to repositories such as ReposiTrak, iFoodDS, TraceGains or your own EPCIS repository. Your team still decides which foods are in scope, writes the traceability plan, and approves what is provided to FDA. V5 does not determine applicability or exemptions.
Frequently asked questions
Q.Has the FSMA 204 compliance date moved?+
Yes. The original date was 20 January 2026. FDA proposed 20 July 2028, and the Continuing Appropriations Act of 2026 directed FDA not to enforce the rule before that date; FDA says it intends to comply. Check FDA's page for the current position.
Q.Does FSMA 204 apply to every food?+
No. It applies to foods on the Food Traceability List and foods containing a listed food as an ingredient in the same form, subject to the exemptions in § 1.1305.
Q.Do I have to send records to FDA routinely?+
No. You make records available within 24 hours of an FDA request, or a reasonable time FDA agrees to. The sortable spreadsheet is required when needed to assist FDA during an outbreak, recall or other public-health threat, unless you are exempt from that requirement.
Q.When do I assign a traceability lot code?+
At initial packing of a RAC (other than fishing-vessel food), first land-based receiving, or transformation, and when receiving an FTL food from an exempt entity without a TLC (unless you are a retail food establishment or restaurant). Not at shipping.
Q.Does the rule require GS1 or EPCIS?+
FDA's summary does not require any particular standard or software. GS1 and EPCIS are common industry choices for sharing the data.
Primary sources
Further reading
- Critical Tracking Event (CTE)The events the rule attaches records to.
- Key Data Element (KDE)The data fields recorded at each event.
- Mock recallExercising whether your records can actually be retrieved.
- GS1-128One common way to carry lot data on case labels.
- FSMA 204 readiness guideLonger planning guide for food sites.
- FSMA 204 softwareHow V5 supports traceability records.
Explore this topic
FSMA 204 sits inside 2 overlapping topic clusters in our glossary. Every neighbour is one click away.
HACCP, FSMA, allergen control and the GFSI-recognised certification schemes.
Want to see how FSMA 204 could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.