FSMA 204 for fresh-cut produce processors: what to record and when

Fresh-cut fruits and vegetables are on the FDA Food Traceability List, so a company that washes, cuts and packs them must keep lot-level records under FSMA 204 unless an exemption applies. Cutting is a “transformation,” which means you assign a new traceability lot code and record what went in and what came out.

This guide covers what counts as fresh-cut, which products are not covered, the records a cutting line keeps, and how it differs from a farm or packinghouse.

Which fresh-cut products are on the list?

FDA’s Food Traceability List has these entries that matter to a cutting room:

• Fruits (fresh-cut): “Includes all types of fresh-cut fruits.”
• Vegetables other than leafy greens (fresh-cut): “Includes all types of fresh-cut vegetables other than leafy greens.” Leafy greens have their own entry.
• Ready-to-eat deli salads (refrigerated): examples include egg, potato, pasta and seafood salad, and meat salads are not included.

Produce that FDA lists as rarely consumed raw is exempt. The list says that fruits and vegetables named in 21 CFR 112.2(a)(1) are exempt under 21 CFR 1.1305(e).

What is not covered?

FDA’s Food Traceability Rule FAQs set some clear limits:

Product	FDA’s answer
Frozen fresh-cut fruits and vegetables	Not covered (item TFTL.12)
Thawed fresh-cut products	Not covered, because “fresh-cut” does not include previously frozen forms (TFTL.24)
Bagged salad mix with fresh lettuce	Covered while the listed food stays in its listed form (TFTL.6)
Frozen pizza with a spinach topping	Not covered (TFTL.6)

Freezing changes the form of the food, and that is why the line falls where it does.

Is cutting a transformation or initial packing?

Cutting is a transformation. FDA’s rule page says transformation “involves manufacturing/processing or changing a food,” and that initial packing means packing a raw agricultural commodity for the first time. Slicing, dicing, peeling and shredding change the food. FDA’s FAQ adds that “transformation does not include the initial packing of a food” (item TT.4).

One more case matters if you buy field-run produce that nobody has packed yet. Under 21 CFR 1.1350(b), when you transform a listed raw agricultural commodity that was not initially packed before your transformation, you keep the initial packing records in 21 CFR 1.1330 for each lot you produce. Section 1.1350(a) opens with “Except as specified in paragraphs (b) and (c),” so for those lots the initial packing records apply instead of the transformation records below, not on top of them.

The FAQ also gives an example (TF.5). An orchard sells apples to a wholesaler, who sells them to a processor that makes sliced apples. FDA says the required records start at the processor. It keeps transformation records and shipping records for the sliced apples.

Repacking a listed food is a transformation too, so a repacker keeps transformation records (TT.4).

What records does a cutting line keep?

Unless 1.1350(b) applies, 21 CFR 1.1350 sets the transformation records. For each listed food you use as an input, you record:

1. The traceability lot code
2. The product description
3. The quantity and unit of measure used from each lot

For the food you produce, you record:

1. The new traceability lot code
2. The location where it was transformed, with any lot code source reference
3. The date the transformation was completed
4. The product description
5. The quantity and unit of measure
6. The reference document type and number for the event

21 CFR 1.1320 says you must assign a traceability lot code when you transform a food. So each new lot you produce gets its own code. Our lot code guide shows how to build one.

Ingredients that are not on the list do not trigger these records. FDA’s deli salad example (TT.1) says a salad with tomatoes, cucumbers and olives needs records for the tomatoes and cucumbers, but not the olives.

What do receiving and shipping records add?

If the whole produce you receive is itself on the list (tomatoes, cucumbers, melons, peppers or leafy greens, for example), 21 CFR 1.1345 lists the receiving records. FDA’s FAQ (TF.5) notes that a processor receiving apples is not required to keep records for the whole apples, so check whether your input is a listed food. Receiving records also do not apply before initial packing. The records are:

• The traceability lot code, quantity and unit, and product description
• The location of the immediate previous source and where you received the food
• The date you received it
• The lot code source location or reference
• The reference document type and number

After the cut, 21 CFR 1.1340 requires you to provide shipping information to the next recipient for each lot you ship. It includes the lot code, quantity, product description, the recipient’s location, your shipping location, the ship date, and the lot code source or source reference. Our distributors guide covers what the other side keeps.

1. 1Receive produce
2. 2Record listed input lot codes
3. 3Cut, wash and pack
4. 4Assign new lot code
5. 5Ship with lot code

Based on 21 CFR 1.1345, 1.1350, 1.1320 and 1.1340. Input records apply when the incoming food is on the list and was already initially packed.

The link between the steps is the point. Where an input is a listed food, the new lot code must tie back to the input lot codes, so a trace from a bag of cut melon can reach the lot code of the packer who supplied it.

Can you skip the rules?

Some businesses can. Under 21 CFR 1.1305:

• Produce that receives commercial processing that adequately reduces microorganisms is exempt if the conditions in 21 CFR 112.2(b) are met (paragraph (d)(1)). Do not assume a fresh-cut wash qualifies; the exemption depends on those conditions.
• A food that another entity (other than a retail food establishment, restaurant or consumer) will give a kill step, or change so it is no longer on the list, can be exempt with a written agreement between shipper and receiver, renewed at least every 3 years (paragraph (d)(6)).
• Retail food establishments and restaurants with an average annual monetary value of food sold or provided of no more than $250,000 over the previous 3 years, on a rolling basis and adjusted for inflation from 2020, are exempt (paragraph (i)).

Whether any of these fits your plant is a fact question. Read our exemptions guide and check with FDA or a food safety professional.

You also need a written plan. 21 CFR 1.1315 says it must describe how you keep records, identify listed foods and assign lot codes, and name a point of contact. Our plan template is a start.

When do I have to comply?

FDA’s rule page says the original compliance date was January 20, 2026. It says FDA proposed to extend the date by 30 months to July 20, 2028, and that Congress directed FDA not to enforce the rule before that date. Our compliance date post tracks the status.

Where Lotcrumb fits

Lotcrumb is being built to read the receiving invoices, cut-room batch sheets and shipping paperwork you already keep, link input lots to the new lot codes, and produce a sortable spreadsheet when someone asks. Join the waitlist for early access.

This guide is general information, not legal or regulatory advice. Whether a product or process is covered or exempt depends on your facts, so confirm it with FDA or a food safety professional.