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Guide

FSMA 204 for produce, in plain English.

What the FDA’s food traceability rule asks of growers, packers, repackers and distributors, and how to keep the records without a second job.

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Earliest enforcement
July 20, 2028
Records to the FDA
24 hours
Keep records for
2 years
In a recall
A spreadsheet

By the Clovero teamUpdated Checked against the FDA’s rule on

Who it covers

FSMA 204 covers businesses that grow, pack, hold or ship foods on the FDA’s Food Traceability List. For produce, the list includes:

  • Leafy greens
  • Tomatoes
  • Peppers
  • Cucumbers
  • Fresh herbs
  • Melons
  • Sprouts
  • Tropical tree fruits
  • Fresh-cut fruits and vegetables

Some businesses are exempt or partly exempt, including some small farms and businesses that sell straight to consumers. The FDA’s rule (21 CFR 1.1305) and its exemption tool say who.

The idea: a lot code that follows the food

Whoever first packs a food on the list gives it a traceability lot code. Everyone after them records that code when they receive and ship it, and doesn’t change it. A business that repacks or otherwise transforms the food usually gives the new lot a new code; a repack of one lot into the same kind of pack, with nothing mixed in, can keep its code. If the FDA asks, each business can show where a lot came from and where it went, one step in each direction. How repacking works

The rule calls each step a critical tracking event, and the facts recorded at each step key data elements. Here are the ones produce businesses meet, in the order the food moves:

Harvesting

When you harvest a raw agricultural commodity on the list. Pass all but the reference document on to the initial packer, with your business name and phone number.

  1. Location of the immediate subsequent recipient (other than a transporter)
  2. Commodity, and variety if it has one
  3. Quantity and unit of measure
  4. Location of the farm where it was harvested
  5. Name of the field or growing area, as the grower names it
  6. Date of harvesting
  7. Reference document type and number

Cooling

When you cool a raw agricultural commodity on the list before it’s first packed. Pass all but the reference document on to the initial packer.

  1. Location of the immediate subsequent recipient (other than a transporter)
  2. Commodity, and variety if it has one
  3. Quantity and unit of measure
  4. Location where you cooled it
  5. Date of cooling
  6. Location of the farm where it was harvested
  7. Reference document type and number

Initial packing

When you pack a raw agricultural commodity on the list for the first time.

  1. Commodity and variety of the food received
  2. Date received, and quantity and unit of measure
  3. Farm where it was harvested, and the field or growing area
  4. Harvester’s business name and phone number
  5. Date of harvesting
  6. Where and when it was cooled, if it was
  7. The traceability lot code you assigned
  8. Product description, quantity and unit of measure of the packed food
  9. Location where you packed it (the lot code source) and the date
  10. Reference document type and number

Shipping

When you ship a food on the list to someone else.

  1. Traceability lot code
  2. Quantity and unit of measure
  3. Product description
  4. Location of the immediate subsequent recipient
  5. Location you shipped it from
  6. Date you shipped it
  7. Location of the traceability lot code source, or its reference
  8. Reference document type and number

Receiving

When you receive a food on the list from someone else.

  1. Traceability lot code
  2. Quantity and unit of measure
  3. Product description
  4. Location of the immediate previous source
  5. Location where you received it
  6. Date you received it
  7. Location of the traceability lot code source, or its reference
  8. Reference document type and number

Transformation (repacking, cutting, mixing)

When you repack, relabel, cut or mix a food on the list. It usually gets a new lot code; a like-into-like repack of a single lot can keep its code.

  1. Each input lot’s traceability lot code, product description and the quantity used
  2. The new traceability lot code
  3. Location where it was transformed (the lot code source)
  4. Date the transformation was completed
  5. Product description of the new food
  6. Quantity and unit of measure of the new food
  7. Reference document type and number

The 24-hour rule

When the FDA asks, you have 24 hours to hand over your records, unless it agrees to more time. In an outbreak or recall, it can ask for them as an electronic, sortable spreadsheet; businesses under certain sales limits can provide them another way (21 CFR 1.1455). Keep records for 2 years.

The traceability plan

Each business also writes a traceability plan: how it keeps the records and where, how it spots foods on the list, how it assigns lot codes, and who to contact. Farms add a map of their fields.

When it applies

The rule’s original compliance date was January 20, 2026. The FDA then proposed moving it to July 20, 2028; as of October 26, 2026 that proposal isn’t final. Separately, Congress directed the FDA not to enforce the rule before July 20, 2028, and the FDA says it intends to comply. Buyers are already asking for lot codes and records, so many businesses are starting now.

How Clovero keeps the records

Clovero records each lot as you receive, repack and ship it, and builds the sortable spreadsheet the FDA can ask for in a recall. Receiving, repacking and shipping each record their part as the work happens, so there’s no second set of paperwork.

See lot traceability in Clovero

This guide is a summary, not legal advice. Read the FDA’s rule for your own business. Some businesses are exempt; the FDA’s rule says who. Clovero keeps the records and doesn’t certify compliance.

Sources

Go deeper.

Questions about FSMA 204.

Does FSMA 204 apply to us yet?

The FDA won’t enforce it before July 20, 2028. Many buyers already ask for lot codes and records, so it’s worth starting before then.

Do we need special software?

No. The rule asks for the records, not a system. Paper or spreadsheets can work, but in a recall you have 24 hours to turn them into one sortable spreadsheet.

What’s a traceability lot code?

The code given to a lot when it’s first packed or transformed, such as repacked. It travels with the food, and everyone after records it.

Keep the records as you work.

Bring one lot. We’ll show you its FSMA 204 records in Clovero.

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