On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register for publication. The rule is scheduled to be published on November 21, 2022.
The rule requires 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"), unless an exemption applies.
Activities including "growing, receiving, transforming, creating, and shipping" are CTEs for which records containing KDEs are required. The required KDEs vary depending on the CTE but may include data like date and time of harvest, location of packer, or quantity received. Each KDE record must contain the traceability lot code of the relevant food. To determine which foods should be included on the FTL, the FDA developed a risk ranking model, which scores commodity-hazard pairs (such as E. coli and leafy greens or listeria and soft cheese).
The rule includes exemptions for certain types of foods and certain persons who manufacture, process, pack, or hold foods on the FTL. Notably, retail food establishments that employ 10 or fewer full-time equivalent employees are exempt from the rule. The rule also exempts certain farms and other originators that produce relatively small quantities of food, among others.
The requirements are intended to "help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death." The FDA notes that while the requirements apply only to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products.
The final rule will become effective 60 days after it is published in the Federal Register. The compliance date for all persons subject to the recordkeeping requirements is two years after the effective date.