The rule applies to any food facility handling products on the FDA’s Food Traceability List, which includes fresh-cut fruits and vegetables, shell eggs, nut butters, fresh herbs, certain cheeses, and ready-to-eat deli salads. If your operation touches anything on that list — even as an ingredient in a larger product — the traceability requirements apply to you.

FSMA 204 doesn’t replace existing food safety regulations. It layers on top of them. What it adds is a standardised set of data points that must be captured at three stages: receiving, transformation, and shipping.

The practical impact is that paper-based traceability systems become significantly harder to maintain. The rule requires records to be sortable and searchable, and that you can produce a complete trace within 24 hours of an FDA request.

Most food manufacturers who already run digital lot tracking are closer to compliance than they think. The gap is usually in the specific KDEs required — particularly traceability lot codes that link receiving records to production records to shipping records in an unbroken chain.