On November 7, the FDA sent the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR).
The final rule includes a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The FDA notes that while the proposed requirements only apply to those foods on the FTL, “they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industrywide.”
The final rule will become effective 60 days after it is published in the Federal Register, which the FDA anticipated would happen within one to two weeks. The compliance date for all persons subject to the recordkeeping requirements is two years after the effective date.