US food traceability records (FSMA 204)

Who it applies to

Businesses that manufacture, process, pack or hold foods on the US Food and Drug Administration's Food Traceability List, including many foods produced outside the US for the US market. The list includes fresh produce such as leafy greens, tomatoes and fresh herbs, shell eggs, nut butters, fresh-cut fruits and vegetables, some cheeses, and finfish and shellfish.

What it requires, in plain terms

The rule, under section 204 of the FDA Food Safety Modernization Act, asks businesses to keep specific records for listed foods.

• Critical tracking events. Records at defined points such as harvesting, cooling, initial packing, shipping, receiving and transformation.
• Key data elements. For each event, specific data, centred on a traceability lot code that follows the food through the supply chain.
• A traceability plan. A written plan describing how records are kept and how listed foods are identified.
• Retrieval on request. The ability to give the FDA an electronic, sortable spreadsheet of the relevant records within 24 hours of a request.

Key dates

As of November 2026:

FDA has said the extension does not change what the rule requires.

What it means for your systems

• Lot codes have to be captured at each event and linked across receiving, production and shipping, often across an ERP, a warehouse system and paper records on the floor.
• The 24-hour sortable spreadsheet is a query over clean, linked records. If those records live in several systems and on paper, assembling it is a scramble.
• Supplier and customer records need consistent identifiers so a lot can be followed one step back and one step forward.

Official sources

• FDA: FSMA final rule on requirements for additional traceability records (opens in a new tab)
• Federal Register: compliance date extension (2025-14967) (opens in a new tab)

How this connects to our work

A data foundation links lot codes and supplier records across the ERP, warehouse system and production records, so the sortable spreadsheet becomes a query rather than a project. See also Manufacturing.