These are the questions food distributors ask most about FSMA 204, the FDA's Food Traceability Rule. Each answer is short and points to the FDA source. Where the answer depends on your exact operation, we say so. This is not legal advice; for questions about your situation, the FDA runs a Technical Assistance Network.

Scope and dates

What is FSMA 204?

Section 204 of the FDA Food Safety Modernization Act told the FDA to set extra recordkeeping rules for foods it designates as higher risk. The result is the Food Traceability Rule, finalized in November 2022 and codified at 21 CFR Part 1, Subpart S. It applies to anyone who manufactures, processes, packs or holds a food on the Food Traceability List (FDA rule page).

Which foods are covered?

The foods on the FDA's Food Traceability List: cheeses other than hard cheeses, shell eggs, nut butters, fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes and tropical tree fruits, fresh-cut fruits and vegetables, finfish (including smoked finfish), crustaceans, molluscan shellfish (bivalves), and refrigerated ready-to-eat deli salads. Foods that contain a listed food as an ingredient in the same form, for example still fresh, are covered too. The list's wording on fresh, fresh-cut and frozen forms matters, so check each entry. The FDA can change the list by notice; additions take effect two years after the notice unless it says otherwise.

When do we have to comply?

The original compliance date was January 20, 2026. The FDA proposed moving it to July 20, 2028, and Congress then directed the FDA not to enforce the rule before that date. The FDA says it intends to comply with that direction. You do not need covered records from before the compliance date.

We only buy and resell. Are we covered?

Yes, if you hold covered foods. Holding is one of the activities the rule covers, and receiving and shipping are tracking events. A transfer between your own sites at different street addresses counts as shipping and receiving too.

Is there a small-business exemption?

Not a general one for distributors. The size-based exemptions are for small produce farms and other small producers, and for retail food establishments and restaurants below a sales threshold. Other exemptions cover, for example, transporters, certain foods that receive a kill step, and produce that is rarely eaten raw. Smaller businesses below the rule's sales thresholds are excused from one requirement, the electronic sortable spreadsheet, but still keep the records. The full list is in section 1.1305 of the rule.

Records

What do we have to record?

Key data elements for each critical tracking event you perform: for most distributors, receiving and shipping, plus transformation if you repack or relabel. Our article on what critical tracking events mean for your software lists every element. You also need a written traceability plan describing how you keep the records, how you identify covered foods, how you assign lot codes if you do, and a point of contact.

Can the records be on paper?

Yes. The rule accepts original paper records, electronic records or true copies such as scans and photos, as long as they are legible and stored safely. The FDA does not require any specific software, and it has said barcode scanning is not required. What paper makes harder is the next answer.

What is the 24-hour rule?

When the FDA asks, you must make the required records available within 24 hours (or a longer time the FDA agrees to), along with whatever is needed to understand them, such as your internal codes and abbreviations.

What is the electronic sortable spreadsheet?

During a foodborne illness outbreak, a recall or another threat to public health, the FDA can ask for the records for specific foods and date ranges or lot codes as a sortable electronic spreadsheet, also within 24 hours. It is not required during a routine inspection. The FDA has posted a template, which it describes as illustrative; you do not have to use it.

How long do we keep records?

Two years from the date you created or obtained them. When you update your traceability plan, keep the previous version for two years.

Does this replace one-up, one-back records?

No. The older Bioterrorism Act records (immediate previous source and immediate subsequent recipient) stay in effect. FSMA 204 adds to them for covered foods.

Lot codes and repacking

Do we assign our own traceability lot codes?

Only when you transform a food (or initially pack a raw agricultural commodity, or are the first land-based receiver of seafood from a fishing vessel). Otherwise you keep the supplier's traceability lot code. The FDA's FAQ says a distributor should not change the code provided to it. If you receive a covered food from a supplier that is not subject to the rule and no code was assigned, you assign one.

Is a case break a transformation?

Repacking a covered food is always a transformation, according to the FDA's FAQ, and the rule's definition also names relabeling and commingling. Breaking down a pallet is not; the rule counts it as holding. The rule does not specifically address opening a case and selling sealed, fully labeled inner packs, so if that is your workflow, read the definition and ask the FDA's Technical Assistance Network.

Enforcement

What happens if we do not comply?

Violating the rule's recordkeeping requirements is a prohibited act under the Federal Food, Drug, and Cosmetic Act, except when a farm commits it. The FDA says it intends to educate before and while it regulates, and usually gives firms a chance to correct problems voluntarily. Beyond that, it can issue warning letters or untitled letters, and the government can seek a court injunction or bring a criminal case. The FDA has said it does not have authority to impose fines for violations of this rule. Imported food can be refused entry if its records appear not to comply.

Getting ready

Where should we start?

Mark your covered items, ask suppliers how lot codes will reach you, and make sure every shipped line records its lot. Then test it: a recall mock drill shows where the gaps are faster than any meeting. Our FSMA 204 guide has a short summary of the rule.

Where does APFoodz fit?

APFoodz records each lot's events as the work happens, from receiving to shipping, so a trace forward or back, or a recall, is a lookup. See FSMA 204 traceability and recalls.