FSMA 204 traceability: the 2028 deadline and what it asks of a produce distributor

FDA's Food Traceability Rule, written under Section 204 of the Food Safety Modernization Act, was supposed to take effect on January 20, 2026. It did not. FDA proposed a 30-month extension in August 2025, and Congress then directed the agency not to enforce the rule before July 20, 2028^{1, 3, 4}. The requirements themselves have not changed, and several of the foods we handle every day are on the list. This is a plain reading of what the rule requires, who is covered, and what the next 21 months look like for a Los Angeles produce house and its customers.

What the rule covers

The rule applies to anyone who manufactures, processes, packs or holds a food on FDA's Food Traceability List, domestic or foreign, as long as the food is bound for U.S. consumption¹. The list is specific. For produce it includes fresh cucumbers, fresh peppers, fresh tomatoes, fresh herbs (FDA names parsley, cilantro and basil as examples and exempts dill), fresh and fresh-cut leafy greens, fresh melons, fresh sprouts, fresh tropical tree fruits such as mango and papaya, and all fresh-cut fruits and vegetables². The rest of the list is shell eggs, nut butters, soft and semi-soft cheeses, finfish, crustaceans, bivalve shellfish and refrigerated ready-to-eat deli salads².

Foods that contain a listed food as an ingredient are covered as well, provided the listed ingredient is still in the form shown on the list^{1, 2}. A clamshell of fresh-cut cucumber is covered because the cucumber is still fresh; canned tomatoes are not, because the list specifies fresh tomatoes².

For a Los Angeles produce house, that means every box of Persian, pickling and American slicing cucumbers, every habanero and Anaheim, every beefsteak and Roma, and every bunch of basil and bag of tarragon in the building. Squash, beans, grapes, pomegranates and persimmons are not on the list².

Critical tracking events and key data elements

The rule is built on two terms. Critical tracking events, or CTEs, are the points in the chain where a record must be made: harvesting, cooling before initial packing, initial packing of a raw agricultural commodity, first land-based receiving of fish, shipping, receiving and transformation¹. Key data elements, or KDEs, are the facts that must be recorded at each of those events¹.

For a distributor the two events that matter are receiving and shipping. The International Fresh Produce Association's July 2026 overview states it directly: processors, wholesalers, distributors and retailers must keep KDEs for receiving, transformation and shipping⁶. IFPA also notes that many of the required shipping data elements already appear on bills of lading, but formats vary from shipper to shipper, which is the practical problem the industry is working through⁷.

Each covered firm also needs a written traceability plan that describes its recordkeeping procedures, how it identifies listed foods, how it assigns traceability lot codes and who FDA should contact; growers must include a farm map¹. Records must be legible and stored so they are not lost, and electronic records may link to supporting documents¹.

The 24-hour rule

The requirement that worries operators most is the response time. When FDA asks, a covered firm must provide its traceability records within 24 hours, or within a reasonable time the agency has agreed to¹. During an outbreak, recall or other public health threat, FDA can also require an electronic sortable spreadsheet of the relevant records¹. IFPA puts the purpose of the whole rule in one line: cut traceback and trace-forward investigations from five or six weeks to five or six days⁶.

IFPA's advice to distributors is to start with that spreadsheet. List every received product that contains a listed food and that you ship; decide how you will know whom you shipped each product to; create a data field for the traceability lot code source, meaning where the product was packed; and review every required data element against the template⁶. IFPA estimates that the Produce Traceability Initiative's case-label standard covers 90 to 95% of what FSMA 204 requires, recommends the PTI harmonized case label with a 2D barcode, and notes that the most common way the industry passes lot-code source information today is the EDI 856 advance ship notice⁶. FDA itself has no label requirement; it wants the data, not a particular sticker⁶.

Who is exempt

The rule contains a full exemption for small retail food establishments and restaurants, and FDA has issued a draft enforcement-discretion policy for certain smaller establishments that fall outside that exemption¹. Farms with average annual produce sales under $25,000 are exempt⁶. FDA can also modify requirements or grant exemptions for a particular food or type of entity through Federal Register notice and comment, and it can grant waivers for economic hardship¹.

Larger restaurants, grocers and commissaries that receive listed foods are covered for the receiving event, which is one reason many retail buyers already require the same data on every case of produce they take in, listed or not⁶.

Why the date moved

FDA's proposed rule of August 7, 2025 lays out the reasons. Some required data elements were not routinely kept or shared across supply chains; many data systems could not talk to each other; distributors in particular struggled to obtain lot codes from suppliers; and the technology to do all of it was still being piloted and tested for interoperability³. Very few firms expected to comply by January 2026, and because traceability is a chain, one non-compliant link breaks it. FDA concluded a phased rollout would not work and proposed a single 30-month delay for everyone, to July 20, 2028³.

FDA's own economics show the trade-off. The agency estimated the delay would forgo $91 million to $112 million a year in public-health benefits while saving industry $54 million to $73 million a year, with $16 million to $22 million of the savings going to small businesses³.

Congress then settled the question. The continuing appropriations act for fiscal 2026 directed FDA not to enforce the rule before July 20, 2028, and FDA has said it intends to comply⁴. The same act told FDA to meet quarterly with regulated firms to find additional flexibilities on lot-level tracking⁴. FDA held a public meeting on that subject on June 15, 2026, received 26 comments on a discussion paper, and has scheduled a second virtual meeting for November 6, 2026, with comments open through December 6⁴. Topics on the table include allowing a reasonable range of lot codes or inferred lot codes for shipments from distribution to retail, simpler rules for intracompany transfers and for returns and food-waste recovery, and recognition of GS1 standards for identifying shipments⁴.

Western Growers noted when FDA first signaled the delay in March 2025 that the extension postpones enforcement but leaves the requirements intact, and that FDA planned to use the time to work with stakeholders and offer technical assistance⁵. That is still the posture: the rule stands, the clock moved.

What it means for Los Angeles buyers

If you buy from a distributor that already runs HACCP-based handling, the receiving side of your own obligation gets easier, because the lot code, product description, quantity and ship-from and ship-to locations should arrive on the paperwork with each pallet^{6, 7}. Ask your suppliers now whether their cases carry PTI labels and whether their invoices or ship notices carry the traceability lot code source⁶. If the answer is no, you have 21 months to change suppliers or get them to change.

For restaurants and markets below the exemption thresholds, the rule does not reach you directly, but your distributor still has to be able to tell FDA within 24 hours which of your deliveries contained a given lot of cucumbers¹. Keep your delivery invoices; they are the receiving record on your end even when the law does not require one.

For our part, we are working through the receiving and shipping data elements now, well ahead of 2028, and we will share lot-level data in whatever format your system needs. The point of the rule is simple even if the paperwork is not: when a recall happens, the fewer boxes that have to be pulled, the better for everyone who handles produce. Call the office if you want to talk through how your receiving records line up with ours.