21 CFR Part 1 Subpart S - Additional Traceability Records for Certain Foods

What it says

Persons who manufacture, process, pack or hold foods on the Food Traceability List must keep records of key data elements associated with critical tracking events, such as receiving, transformation and shipping, link them with traceability lot codes, maintain a traceability plan, and provide an electronic sortable spreadsheet to FDA within 24 hours of a request in an outbreak or similar situation. FDA has extended the compliance date, so check the current date.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The rule applies only to foods on the Food Traceability List, so the first task is to find out whether any of your products or ingredients are covered.
• Traceability lot codes carry the link from one critical tracking event to the next, so the code assigned and passed on is central.
• The goal is faster tracing during an outbreak, so records need to be searchable and producible quickly, not simply retained.

What FDA inspectors look for

• Whether the facility has determined which foods are covered and has a written traceability plan.
• Whether key data elements are recorded for each critical tracking event.
• Whether the facility can produce records in the required sortable electronic format within the time allowed.

Related regulations