LotcrumbJoin the waitlist
All guides

FSMA 204 key data elements: what to record at each critical tracking event

, 7 minute read

Under the FDA Food Traceability Rule, you keep records of specific facts, called key data elements (KDEs), for each critical tracking event (CTE) you perform on a listed food. The KDEs differ by event. This guide lists them in plain language, based on 21 CFR 1.1325 through 1.1350, and then shows what a small packer and a distributor actually keep.

If you are still deciding whether a product is covered, start with FSMA 204 in plain English.

Four terms that appear everywhere

  • Location description. Business name, phone number, physical address (or geographic coordinates), and city, state and zip. Foreign locations give comparable information including country.
  • Product description. Product name, including brand name, commodity and variety where they apply, plus packaging size and style.
  • Quantity and unit of measure. For example, 6 cases or 200 pounds.
  • Reference document type and number. The invoice, bill of lading, purchase order, advance ship notice, work order, batch log or similar record that carries the data.

The traceability lot code (TLC) and the TLC source (the location description for where the code was assigned, or a TLC source reference such as an FDA registration number or web address) travel with the food from the point the code is assigned.

Every KDE must be linked to its traceability lot. Putting the lot code on the invoice or bill of lading is one way. The same row of a spreadsheet is another.

What to record, event by event

Harvesting (farms)

  • Location description for the next recipient, other than a transporter
  • Commodity and variety, quantity and unit of measure
  • Location description for the farm
  • Produce: the name of the field or growing area, matching the name the grower uses (aquaculture: the pond, tank or cage name)
  • Date of harvest
  • Reference document type and number

Send to the initial packer: your business name, your phone number, and everything above except the reference document.

Cooling, before initial packing

  • Location description for the next recipient, other than a transporter
  • Commodity and variety, quantity and unit of measure
  • Location description for where you cooled the food, and the cooling date
  • Location description for the farm where it was harvested
  • Reference document type and number

Send the same items, minus the reference document, to the initial packer.

Initial packing of a raw agricultural commodity

You assign the TLC here. Keep, linked to that lot:

  • Commodity and variety, date received, quantity and unit of measure received
  • Farm location description and, for produce, the field or growing area name
  • Harvester’s business name and phone number, and the harvest date
  • Where and when the food was cooled, if it was
  • The TLC you assigned
  • Product description and quantity of the packed food
  • Location description for where you packed it (the TLC source), plus a TLC source reference if you use one
  • Date of initial packing
  • Reference document type and number

Sprout packers keep extra seed-related records. If you receive the food from a business the rule does not cover, such as a very small farm, a shorter list applies (21 CFR 1.1330(c)).

First land-based receiving, for seafood from a fishing vessel

  • The TLC you assigned
  • Species or market name (or product description if packaged)
  • Quantity and unit of measure
  • Harvest date range and locations for the trip, using a widely recognized standard such as the FAO Major Fishing Area list
  • Location description for the receiver (the TLC source), and the date landed
  • Reference document type and number

Shipping

  • TLC, quantity and unit of measure, product description
  • Location description for the next recipient, other than a transporter
  • Location description for where you shipped from
  • Ship date
  • Location description for the TLC source, or the TLC source reference
  • Reference document type and number

You must also give the recipient everything above except the reference document.

Receiving

  • TLC, quantity and unit of measure, product description
  • Location description for the previous source, other than a transporter
  • Location description for where you received the food
  • Receiving date
  • Location description for the TLC source, or the TLC source reference
  • Reference document type and number

Transformation

For each new lot you make, keep, linked to the new lot:

  • For each listed food used: its TLC, product description, and the quantity used from that lot
  • The new TLC
  • Location description for where you transformed it (the TLC source)
  • Date the transformation was completed
  • Product description and quantity of the new food
  • Reference document type and number for the transformation

Transformation includes cutting, mixing, repacking and relabeling when the output is a listed food. Retail food establishments and restaurants do not keep transformation records for food they sell or send straight to consumers.

A distributor: receiving and shipping

A distributor who only moves cases keeps receiving and shipping records, and no others.

  • At receiving, capture the supplier’s TLC, TLC source, quantity, product description, supplier location, your location and the date.
  • At shipping, pass the same TLC and TLC source to the customer, with your own location, the customer’s location and the ship date.
  • Do not create a new TLC for food that arrives with one. Only transformation changes it. The exception is food from a supplier the rule does not cover, where you assign a code if none exists (retailers and restaurants excepted).

FDA’s February 2026 draft guidance, which is not binding, says breaking a pallet to ship single cases is not a transformation, and neither is putting an internal tracking sticker on a case. Repacking or relabeling is.

A small packer: initial packing and shipping

A packer who buys from farms keeps initial packing and shipping records.

  • Record the farm, harvester, field name and dates from the paperwork the farm sends.
  • Assign a TLC to each packed lot and record the packing location as the TLC source.
  • On every shipment, send the TLC, TLC source, quantity, product description, locations and date.
  • Receiving records are not required for a raw agricultural commodity that arrives before it is initially packed (21 CFR 1.1345(c)). The initial packing record covers it.

If you also harvest or cool, add those records.

Checklist

  1. For each listed product, mark the events you perform.
  2. Compare each event’s list with your invoices, bills of lading and production sheets.
  3. Fix the usual gaps: phone numbers in location descriptions, the TLC source, and quantities without units.
  4. Put the TLC on every document that carries the KDEs.
  5. Write down where each record lives. Your traceability plan must describe the format and location of your records.
  6. Keep records for two years.

Existing records count. You do not have to copy data into a new system if what you already keep has the required information.

Where Lotcrumb fits

Lotcrumb is being built to pull key data elements from the invoices, bills of lading and labels you already handle, check each event against the required list, and flag what is missing. Join the waitlist for early access.

This guide is general information, not regulatory advice. The rule has exceptions for specific businesses and foods, so confirm your exact records with FDA guidance or a food safety professional.