Find out if the FDA Food Traceability Rule covers your food business, and exactly what records you will need.
FSMA 204 makes companies that handle foods on the FDA Food Traceability List keep new records at every step. Answer two questions to see whether you are covered, which tracking events apply to your role, and get a traceability-plan starter built for what you handle.
within 24 hrs
The seven Critical Tracking Events, in order down the chain
FSMA 204 records attach at specific points as a food moves. A traceability lot code is assigned once, then carried and matched at every later event. Your report highlights the stations that apply to your role.
Covered or exempt turns on two things: the food, then your role
The rule applies to anyone who manufactures, processes, packs, or holds a food on the Food Traceability List, at each point in the chain, unless a specific exemption applies. It reaches domestic operations and importers alike. The free check walks you through both questions and cites the exemption that fits.
As at July 12, 2026 FDA will not enforce the Food Traceability Rule before July 20, 2028. The substantive requirements (tracking events, data elements, plan, 24-hour records) are unchanged.
Check my scope, freeA working document, not a rehash of the rule
Built from your role and the foods you handle. Every determination cites its CFR section and the FDA page, with the check date on the report.
Your coverage determination
Covered or likely exempt, with the specific reason and the exemption subsection cited (for example 1.1305(i) for a retail food establishment at or below $250,000). Where a self-reported number triggers an exemption, we cite it and say it depends on your figures.
The compliance date, dated
FDA will not enforce before July 20, 2028, with the one-line basis (the 30-month extension plus the congressional non-enforcement directive) and the check date stamped on your report.
Which tracking events apply to your role
A role-to-CTE map and a chain-of-custody strip that highlights your stations, so you know exactly which events you are responsible for recording.
The exact data elements you must capture
For each event that applies to you, a ready-to-fill Key Data Element record template, with the traceability lot code called out as the spine that links every record.
Your Traceability Plan starter
The five required elements of 21 CFR 1.1315 as fill-in-the-blank sections: records procedures and where records live, how you identify FTL foods, how you assign or receive lot codes, your point of contact, and the farm map for growers, with the 2-year retention note.
What you send to FDA on request
The 24-hour rule, the electronic sortable-spreadsheet demand during an outbreak or recall, and the small-entity alternative, so you know the output format you must be able to produce.
Dated action checklist
Concrete steps working back from July 20, 2028: set a lot-code scheme, write the plan, wire data capture into receiving and shipping, confirm partners will pass the required elements forward, and run a mock 24-hour records pull.
Sources and citations
Every point cites its CFR section and the FDA page, with the check date, so anyone who reviews your file can trace it back to the rule.
If you handle one of these, the rule can follow it to you
The Food Traceability List (as at July 12, 2026). The rule also reaches foods that contain a listed food as an ingredient, where that ingredient stays in the same form it takes on the list, for example a fresh soft cheese inside a finished product.
| Category | Examples |
|---|---|
| Cheeses, fresh soft and soft unripened | Cottage cheese, cream cheese, mozzarella, queso fresco, ricotta |
| Cheeses, soft ripened and semi-soft | Brie, Camembert, blue, and similar |
| Shell eggs | Eggs in the shell from domesticated hens |
| Nut butters | Peanut, almond, and other nut butters |
| Produce, fresh | Cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits |
| Fresh-cut produce | Fresh-cut leafy greens, fresh-cut fruits, fresh-cut vegetables other than leafy greens |
| Seafood, fresh and frozen | Finfish (including smoked finfish), crustaceans, bivalve mollusks |
| Ready-to-eat deli salads | Potato salad, egg salad, pasta salad, coleslaw |
Source: FDA Food Traceability List. FDA can revise the list, so we treat it as a dated snapshot and re-verify it. See our sources.
Two different dollar thresholds, and several role and process carve-outs
The exemptions live in 21 CFR 1.1305. The two most-confused figures are the $25,000 small-farm produce threshold and the $250,000 small retail and restaurant threshold. They are not the same test.
Small produce farms
Average annual produce sales of no more than $25,000 (rolling, inflation-adjusted from a 2020 baseline).
Small shell-egg producers
A farm with fewer than 3,000 laying hens at that farm.
Small retail and restaurants
Average annual food sales of no more than $250,000 over the previous 3-year period (rolling, inflation-adjusted).
Direct-to-consumer farm sales
Food produced and sold or donated directly to a consumer from the farm.
Kill step or commercial processing
Foods that receive a kill step or processing that adequately reduces pathogens, or are changed so they are no longer an FTL food.
Transporters
A person who transports food is exempt with respect to that transportation activity.
Other carve-outs include rarely-consumed-raw produce (1.1305(e)), foods under USDA exclusive jurisdiction (1.1305(g)), fishing vessels (1.1305(m)), and nonprofit and personal-consumption cases. The report checks these against your answers.
Two questions, then a report you can build a plan from
Tell us the foods and your role
Pick the FTL foods you handle and your role in the chain: grower, cooler, packer, seafood first receiver, manufacturer, distributor, importer, or retailer.
We determine coverage
Covered or likely exempt, with the exemption cited, plus the tracking events and the count of data elements you will record at each.
Get your $39 report
A role-specific PDF: per-event record templates, a traceability-plan starter, the 24-hour rule, and a dated action checklist.
Build your FSMA 204 report
Answer below, or run the free scope check first and we will carry your answers over. One-time $39, delivered as a PDF to your inbox.
FSMA 204, in plain terms
When does FSMA 204 take effect?
As at July 12, 2026, FDA will not enforce the Food Traceability Rule before July 20, 2028. The date rests on a proposed 30-month extension (published August 7, 2025) and a congressional directive in the FY2026 appropriations act that FDA not enforce before then. The substantive requirements did not change.
Federal Register 2025-14967; FDA constituent updateWhich foods are on the Food Traceability List?
Certain cheeses, shell eggs, nut butters, cucumbers, fresh herbs, leafy greens (including fresh-cut), melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, finfish, crustaceans, bivalve mollusks, and ready-to-eat deli salads.
FDA Food Traceability ListDoes the rule apply if a listed food is only an ingredient in my product?
Yes, where the listed food used as an ingredient stays in the same form it takes on the list, for example a fresh soft cheese used in a finished product. If the ingredient is changed so it is no longer an FTL food, that can be a different situation.
FDA Food Traceability List pageIs my farm exempt if I sell under $25,000 of produce?
A small produce farm with average annual produce sales of no more than $25,000 (inflation-adjusted from a 2020 baseline) is exempt. That is a different test from the $250,000 retail and restaurant threshold.
21 CFR 1.1305(a)(1)Are restaurants and small retailers exempt?
A retail food establishment or restaurant with average annual food sales of no more than $250,000 over the previous 3-year period (inflation-adjusted) is exempt.
21 CFR 1.1305(i)What is a Critical Tracking Event?
A point in the supply chain where FSMA 204 requires you to keep records: harvesting, cooling, initial packing, first land-based receiving (seafood), shipping, receiving, and transformation.
21 CFR 1.1325 to 1.1350What is a Key Data Element?
A specific field you must record at a tracking event, such as the traceability lot code, product description, quantity, location descriptions, dates, and the reference document type and number.
21 CFR 1.1325 to 1.1350What is a traceability lot code and who assigns it?
It is the identifier that links a food to its records. It is assigned when you initially pack a raw agricultural commodity, do first land-based receiving of a fishing-vessel food, or transform a food, then it travels with the food down the chain.
21 CFR 1.1320, 1.1330, 1.1335, 1.1350What must my Traceability Plan include?
Five parts: how you keep records and where they live, how you identify FTL foods, how you assign lot codes, a point of contact, and (for growers) a farm map. Keep it current and retain prior versions for 2 years.
21 CFR 1.1315What do I have to give FDA, and how fast?
You must make required records available to FDA within 24 hours of a request. During an outbreak, recall, or other public-health threat, FDA can ask for the information as an electronic sortable spreadsheet within 24 hours. Smaller entities that meet the criteria may provide it another way.
21 CFR 1.1455