FSMA Rule 204, also known as the FDA Food Traceability Rule, establishes additional recordkeeping requirements for certain foods. Organizations that manufacture, process, pack or hold covered foods must maintain Key Data Elements connected to specific Critical Tracking Events throughout the supply chain.

The rule is intended to help the FDA identify and remove potentially contaminated food from the market more quickly. Better lot-level traceability can support faster investigations and recalls while helping reduce the public health impact of foodborne illness.

The rule applies to foods on the FDA Food Traceability List. These include certain soft and semi-soft cheeses, shell eggs, nut butters, fresh cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes and tropical tree fruits, along with fresh-cut fruits and vegetables, certain seafood products and ready-to-eat deli salads. Foods containing a listed ingredient may also be covered when that ingredient remains in the same form in which it appears on the list.

The rule generally applies to domestic and foreign organizations that manufacture, process, pack or hold foods on the Food Traceability List for consumption in the United States. Certain exemptions and modified requirements may apply depending on the food, business and activity involved.

The FDA has proposed moving the compliance date to July 20, 2028, and Congress has directed the agency not to enforce the rule before that date. Because implementation requires coordination among multiple supply chain partners, food companies should begin evaluating their processes, systems and data needs well before enforcement begins.

Critical Tracking Events, or CTEs, are activities in the food supply chain for which additional traceability records may be required. The rule identifies harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation as CTEs.

Key Data Elements, or KDEs, are the specific pieces of information that must be maintained for a Critical Tracking Event. Depending on the activity, these may include the traceability lot code, product description, quantity, unit of measure, relevant locations, dates and reference-document information.

A traceability lot code is a unique descriptor used to identify a traceability lot within an organization’s records. Once assigned, it must remain connected to the relevant Key Data Elements as the food moves through covered supply chain activities.

The FDA allows required records to be maintained as original paper records, electronic records or true copies, provided they are legible and protected against loss or deterioration.

Retailers may establish their own data exchange, labeling or implementation expectations in addition to FDA requirements. Food companies should understand both the regulatory requirements that apply to their operations and the specific expectations of the retailers and supply chain partners they serve.

Companies can begin by identifying covered foods, mapping the Critical Tracking Events they perform and determining which Key Data Elements they already capture. They should also evaluate how information moves between internal systems and supply chain partners, document their procedures and test their ability to retrieve and exchange traceability records.

Lineage supports the operational processes and technology used to capture, maintain and exchange traceability information during warehouse receiving, storage and shipping. This may include warehouse management systems, EDI connections, labeling support and customer visibility tools.

No. Lineage works alongside customers to support traceability processes within its operations but does not provide regulatory or legal compliance consulting. Each organization remains responsible for determining how the Food Traceability Rule applies to its business and for meeting its own regulatory obligations.