By Jeffrey H. Brochin, J.D.
Proposed FDA rule would establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods designated for inclusion on the Food Traceability List.
The FDA has issued a proposed rule that would require certain entities in the food industry to establish and maintain records containing information on critical tracking events (CTEs) in the supply chain for designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the agency 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. The FDA has issued the proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA) as mandated by Congress (Proposed rule, 85 FR 59984, September 23, 2020).
Overhaul of U.S. food safety. The FSMA was signed into law in January, 2011 as part of the overhaul of U.S. food safety law in order to better ensure the safety and security of the nation’s food supply. Section 204(d) of the FSMA requires that the FDA establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that the agency designates as high-risk, in order to facilitate the rapid and effective traceability of such foods.
Congress directed the FDA to adopt the recordkeeping requirements to allow the agency to identify the immediate previous sources and immediate subsequent recipients of foods (commonly referred to as ‘‘one-up, one-back’’ recordkeeping) to address credible threats of serious adverse health consequences or death to humans or animals resulting from foods being adulterated, including by bioterrorism, or misbranded with respect to allergen labeling.
Key Data Elements. The core components of the proposed rule are the requirements to establish and maintain records containing key data elements (KDEs) associated with CTEs, in a listed food’s supply chain including the growing, receiving, transforming, creating, and shipping of listed foods. The proposed recordkeeping requirements emphasize the importance of documenting the applicable traceability of lot codes and linking those codes to other KDEs at critical points in the supply chain of a food to aid product tracing during an investigation of a foodborne illness outbreak or during a recall.
Full and partial exemptions. The proposed rule includes several proposed full and partial exemptions from the additional recordkeeping requirements, including some specified by Congress and some proposed by the agency on its own initiative. Proposed full exemptions include those for small retail food establishments, small farms, farms selling food directly to consumers, certain food produced and packaged on a farm, food that receives certain types of processing, and transporters of food.
Partial exemptions would apply to certain commingled raw agricultural commodities (not including fruits and vegetables subject to the produce safety regulations), fishing vessels, retail food establishments that receive a listed food directly from a farm, and farm to school and farm to institution programs. The proposed rule also includes special requirements for foods on the Food Traceability List that are subjected to a "kill step" which the agency proposes to define as processing that significantly minimizes pathogens in a food by way of cooking, pasteurization, heat treatment, high-pressure processing, and irradiation.
Procedures for modification and waiver. The proposed rule also contains procedures under which persons subject to the proposed rule could request modified requirements or an exemption from the recordkeeping regulations for a specific food or a type of entity on the grounds that application of the requirements to that food or type or entity is not necessary to protect public health. In addition, the proposed rule includes procedures for requesting a waiver of one or more of the requirements for an individual entity or a type of entity on the grounds that having to meet the requirements would impose an economic hardship.
Industry stakeholders wishing to comment on the proposed rule may submit comments until January 21, 2021.
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