FSMA 204 and the Food Traceability Rule: what produce businesses must keep

What the rule is, and who it covers

The rule's formal name is "Requirements for Additional Traceability Records for Certain Foods". It establishes recordkeeping requirements, beyond those already in FDA regulations, for persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

It also reaches foods that contain a listed food as an ingredient, as long as that listed food stays in the same form (for example, fresh) in which it appears on the list. So a grower, a packer, a cold store, a distributor, and an importer of a listed produce item can each be a covered entity for their step in the chain.

Is your produce on the Food Traceability List?

The FTL is the specific set of foods the rule applies to, not all produce. For fresh produce it includes fresh-cut fruits and vegetables and a defined set of fresh leafy greens: arugula, baby leaf, butter lettuce, chard, chicory, endive, escarole, green leaf, iceberg lettuce, kale, red leaf, pak choi, romaine, sorrel, spinach, and watercress, among other listed items.

The list is specific and it is the authority, so check your exact commodity against the FDA Food Traceability List rather than assuming. If none of what you handle is on the list, the additional records in this rule do not apply to you (though your normal FDA recordkeeping still does).

The compliance date: now July 20, 2028

The original compliance date for the recordkeeping requirements was January 20, 2026. The FDA has since proposed to extend that date by 30 months, to July 20, 2028, citing the time affected businesses need to implement the requirements and their reliance on accurate data from supply-chain partners.

Alongside that, Congress directed the FDA, through the Continuing Appropriations and Extensions Act of 2026, not to enforce the rule before July 20, 2028, and the FDA has said it intends to comply with that direction. The practical takeaway: the deadline moved, but the requirements did not, and the businesses that fare best are the ones already keeping lot-level records rather than waiting.

What you actually record: lot codes, events, and data elements

The rule works through three ideas. A traceability lot code is the identifier that follows a lot through the chain. Critical Tracking Events (CTEs) are the points where you must keep records, such as harvesting, initial packing, shipping, receiving, and transformation. Key Data Elements (KDEs) are the specific pieces of information you record at each event.

The FDA gives examples of KDEs: the traceability lot code, the date the product was received, the date it was shipped, and a product description. The through-line is that every covered lot needs an unbroken record from where its lot code was assigned to where it left your control, with the KDEs captured at each event and available to the FDA within 24 hours of a request.

Getting ready without a paperwork project

The rule rewards systems that already assign a lot code and capture the who, what, when, and where at each step. If your records live in binders and spreadsheets, the gap is usually at transformation, when received produce is packed into new cartons and the link back to the source lot is easy to lose.

Fernable keeps that chain automatically: every receival, pack run, pallet, and dispatch is tied to a traceability lot code, so the receiving, transformation, and shipping records the rule asks for are a by-product of running the operation, not a separate compliance exercise. When a lot is questioned, the one-back and one-forward trace is a lookup, not an investigation.

This guide summarises the rule for orientation and is not legal advice. Confirm the current requirements, the Food Traceability List, and compliance dates against the FDA Food Safety Modernization Act (FSMA) traceability pages before you rely on them.