December 01, 2022

FDA proposes Final Rule to prevent food borne illnesses

FDA proposes Final Rule to prevent food borne illnesses

By: Sydney Sheffield 

The Food and Drug Administration (FDA) has announced that it has submitted the FDA Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods. The rule is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the FDA has designated for inclusion on the Food Traceability List. FDA has submitted the rule to the Office of the Federal Register (OFR), meeting the November 7, 2022, deadline.

The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. These requirements are intended to help the FDA rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. This final rule is proposed with the FSMA. 

Using public comments and submitted information, FDA developed a draft risk-ranking model and collected data to populate the model for chemical and microbiological hazards associated with specific foods, with technical assistance from external expert panels. The model was subjected to two peer reviews as well. 

Foods on the Food Traceability List include cheeses other than hard cheeses, shell egg, nut butter, fresh cucumbers, fresh herbs, fresh leafy greens, fresh melons, fresh peppers, fresh sprouts, fresh tomatoes, fresh tropical tree fruit, fresh-cut fruits and vegetables, finfish, crustaceans, mollusks, bivalves, and ready-to-eat deli salads.

The proposed rule would also require that:

  • Records are maintained as either original paper records, electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss.

  • Traceability records are provided to FDA as soon as possible but no later than 24 hours after a request is made. 

  • An electronic sortable spreadsheet containing relevant traceability information be provided to the FDA within 24 hours of a request when necessary to assist the FDA during an outbreak, recall, or other threat to public health.

The publication of the final rule is managed by the OFR and the FDA anticipates publication within one or two weeks after submission.