On September 21, 2020, the US Food and Drug Administration (FDA) formally proposed a new rule to lay the foundation for additional traceability recordkeeping requirements for certain foods, based on Section 204 of the Food Safety Modernization Act (FSMA). Rooted in core concepts in current food traceability practices, the proposed rule outlines which foods are subject to the requirements (deemed the “Food Traceability List”), the collection and sharing of Key Data Elements (KDEs) at Critical Tracking Events (CTEs) on a batch/lot level, and traceability data request requirements in the event of food safety investigations by FDA.
The highly anticipated proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is emblematic of FDA’s New Era of Smarter Food Safety Blueprint, an initiative that will guide the FDA over the next decade. The rule implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA) while also taking authority from section 414 of the Food, Drug, & Cosmetic Act and Sections 311, 361, and 368 of the Public Health Service Act. It will be available for public comment for 120 days after its official publication in the Federal Register.
According to the FDA, FSMA Section 204 instructs the FDA to develop additional recordkeeping requirements for foods determined to be of high risk to public health. The FDA determined the Food Traceability List (FTL) through a combination of expert external panels, public comments, and a risk-ranking model which takes into account chemical and microbiological hazards and their association with specific foods. The criteria for inclusion into the FTL include outbreak frequency, illness severity, contamination likelihood, pathogen grow potential, probability of contamination in manufacturing, consumption rate by consumers, and the costs associated with illness. The risk-rank model methodology and results for determining the FTL can be found on FDA’s website.
After outlining the FTL, the proposed rule goes into great detail on the expectations and requirements for product/ingredient traceability of FTL foods, based on the recommendations of the Institute of Food Technologists’ report. The proposed requirements under this rule aim to aid the FDA in rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks by requiring those who manufacture, process, pack or hold foods to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). Key Data Elements are product attributes which aid FDA in responding to the outbreak including identifiers, and Critical Tracking Events are the pertinent junctures in the supply chain where the KDEs should be collected. Of particular importance is the necessity of traceability records to be linked from previous CTEs, thereby enabling “end-to-end” traceability.
Finally, the proposed rule mandates that how traceability records be kept, that companies provide FDA traceability records within 24 hours of request, and that traceability records be in the form of a sortable electronic spreadsheet to assist with outbreaks, recalls or other public health threats.
The proposed rule by FDA represents a paradigm shift from 1-up, 1-down recordkeeping to end-to-end traceability capabilities by industry. To read more information, FDA has set up an extensive website which goes into detail on all the above requirements.
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