FSMA 204 food traceability compliance for small food manufacturers

When do you have to comply?

The original compliance date was January 20, 2026. On August 7, 2025 the FDA published a Federal Register proposal to extend it by 30 months, to July 20, 2028, and clarified that the extension does not change the rule's requirements.

Afterwards, the Continuing Appropriations Act of 2026 (Pub. L. 119-37) directed the FDA not to enforce the rule before July 20, 2028, and the FDA says it will comply with that directive. Section 780 of that law also directs the FDA to engage quarterly with industry to identify additional flexibilities for the lot-level tracking requirement.

The new date is not final yet. As of November 11, 2026, the rule's Federal Register docket (FDA-2014-N-0053) contains the August 7, 2025 extension proposal but no final rule adopting it, and an FDA notice from October 9, 2026 still describes the extension as proposed. The requirements have not changed, so the extra time is for getting ready.

Note: the "Getting Started" section of the FDA's page on the rule still says the compliance date is January 20, 2026, even though the same page explains the proposed extension and the Congressional directive.

Who is covered?

The rule applies to anyone who manufactures, processes, packs or holds foods on the Food Traceability List (FTL) for consumption in the United States, domestic or foreign. It also applies to foods that contain a listed ingredient, if that ingredient stays in the form in which it appears on the list (for example, fresh).

The rule does not apply to foods under the exclusive jurisdiction of the USDA under the meat, poultry and egg products inspection laws (21 CFR 1.1305(g)).

The Food Traceability List

The FDA's list includes:

• Cheeses other than hard cheeses (fresh soft, soft ripened or semi-soft cheeses made from pasteurized milk, and unpasteurized-milk cheeses other than hard cheeses). IMS-listed Grade "A" cottage cheese is exempt.
• Shell eggs and nut butters.
• Fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes and tropical tree fruits.
• Fresh-cut leafy greens, fruits and vegetables.
• Finfish (fresh, frozen and previously frozen), smoked finfish, crustaceans and bivalve mollusks.
• Refrigerated ready-to-eat deli salads.

Critical tracking events (CTEs) and key data elements (KDEs)

The critical tracking events are harvesting, cooling, initial packing, first land-based receiving (for seafood), shipping, receiving and transformation. A manufacturing plant usually has three: receiving, transformation and shipping. At each one you keep key data elements linked to the traceability lot code.

When receiving (21 CFR 1.1345): lot code, quantity and unit of measure, product description, location of the immediate previous source, receiving location, date received, location of the traceability lot code source (or a reference to it), and the reference document type and number.

When transforming (21 CFR 1.1350): for each listed ingredient, the lot code, description and quantity used; for the new product, the new lot code, the location where it was transformed, the date, the description, the quantity and the reference document.

When shipping (21 CFR 1.1340): lot code, quantity and unit of measure, description, location of the immediate subsequent recipient, location you shipped from, ship date, lot code source and reference document. You must pass all of that data to your customer except the reference document.

The traceability lot code

A traceability lot code is assigned when a raw agricultural commodity is initially packed, when seafood is first received on land, or when a food is transformed. A new one is not created for other activities, such as shipping. For a manufacturer, this means each lot you produce with a listed ingredient needs its own code, linked to the codes of the ingredients you used.

The traceability plan

21 CFR 1.1315 requires a traceability plan that includes:

• The procedures you use to maintain the records the rule requires, including their format and location.
• The procedures you use to identify the listed foods you manufacture, process, pack or hold.
• How you assign traceability lot codes, if applicable.
• A point of contact for questions about the plan and the records.
• If you grow or raise a listed food (other than eggs), a farm map, or a map of aquaculture containers, with locations and coordinates.

Keeping the plan current

You update the plan as needed so it reflects your current practices, and you keep the previous version for 2 years after you update it (21 CFR 1.1315(b)).

Producing records within 24 hours

Records must be made available to the FDA within 24 hours of a request, or within a reasonable time the FDA agrees to. They can be paper, electronic or true copies, and they are kept for 2 years (21 CFR 1.1455).

During an outbreak, recall or other public health threat, the FDA can request them as an electronic sortable spreadsheet. The FDA's template is optional.

Exemptions that matter for small businesses

The size-based exemptions in 21 CFR 1.1305 are for small farms and producers (average annual sales of no more than $25,000), shell egg producers with fewer than 3,000 laying hens, and retail food establishments and restaurants with average annual sales of no more than $250,000. None of those is a size-based exemption for manufacturers. For a small manufacturer, the size-based relief is different: if its average annual food sales are no more than $1 million, it does not have to provide the sortable spreadsheet and can provide the information in another form (21 CFR 1.1455). All thresholds are averages of the previous 3 years, adjusted for inflation from 2020.

Other exemptions that may apply to a manufacturer:

• Foods that receive a kill step, such as cooking: whoever applies the kill step only keeps the receiving record and a record of the kill step (1.1305(d)(3)).
• Foods you change so they are no longer on the list: you only keep the receiving record (1.1305(d)(4)).
• Foods that already received a kill step before reaching you (1.1305(d)(5)).
• The FDA can also grant exemptions or modified requirements, and waivers for economic hardship, through the rule's process.

What to do now

Although the FDA will not enforce the rule before July 20, 2028, the requirements have not changed. A small manufacturer can start like this:

• Check your recipes and raw materials against the Food Traceability List.
• Check whether an exemption applies (for example, a cooking step) using the FDA's exemptions tool and section 1.1305.
• Decide how you will assign lot codes to what you produce.
• Test whether, today, you can pull together for one lot who supplied each listed ingredient and who you shipped the product to, in under 24 hours.
• Write a draft of your traceability plan.