On December 7th, FDA presented a webinar on the new Final Rule for additional record requirements for the traceability of certain foods. Excellent webinar, available on YouTube. The presentation slides and the Final Rule are also below:
The rule covers certain cheeses, shell eggs, nut butters, fresh herbs, certain fresh fruits and vegetables, several types of fish, crustaceans, and mollusks, and ready-to-eat salads, for both domestic and imported foods. Please see the webpage for the full Food Traceability List and for definitions and exemptions. Note that if the food is merely an ingredient, it can still be covered.
The Exemption Tool on the webpage goes over, for example, exemptions for the size of the business in terms of yearly sales, which are adjusted for inflation. Certain foods and processing stages can have partial exemptions.
Covered persons in the supply chain (including for example, packers, holders, distributors, restaurants) will need to keep records of certain Key Data Elements (such as a Traceability Lot Code) and Critical Tracking Events depending on where a covered person fits in the supply chain and what operations have been performed on the food. A Traceability Plan that describes internal procedures used to maintain the records is required. In the event of an outbreak, the covered entity must furnish FDA with the requested elements within 24 hours in the form of an electronic sortable spreadsheet and any information needed to interpret it.
Records can also be kept by a third-party agent, for example, a customs broker. But the covered entity is the responsible party.
Enforced Compliance for the Final Rule is planned for January 20, 2026. So if you are a covered entity, you will want to start researching and shopping soon for possible recordkeeping software that fits your needs. FDA does not prescribe a format for the records, so companies can maintain legible written or electronic records in any language. However, a translation must be provided in a reasonable time period if FDA asks for a translation.
Recordkeeping compliance audits may be performed by FDA field offices but also by local, state and tribal authorities, all the way down to the restaurant and retail levels.
Covered entities should begin reviewing record transmission and retention with their suppliers and buyers now. Under the Final Rule, confidentiality can be maintained, as the transmitter’s identity can be recorded as merely a job title, and not a specific person’s name. A food facility registration number can also be used to ensure confidentiality.