Will FDA’s New Food Traceability Rules Make Our Food Supply Safer? The origin of outbreaks should be detected faster, and the bar has been raised on recordkeeping requirements.
(FSMA). These foods include fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers and tropical tree fruits, as well as fresh- cut fruits and vegetables and ready- to-eat deli salads. Key features of the rule include: Critical Tracking Events: at specific points in the supply chain – such as harvesting, cooling, initial packing, receiving, transforming and shipping FTL foods — records containing Key Data Elements are required. Traceability Plan: information es - sential to help regulators understand an entity’s traceability program. These include a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceabil- ity plan and a farm map for those that grow or raise food on the FTL. Additional Requirements: main - tenance of records as original paper or electronic records, or true copies; providing requested records to the FDA within 24 hours of a request (or within a reasonable time to which the FDA has agreed); and providing records in an electronic sortable spreadsheet when necessary to assist the FDA during an outbreak, recall or other threat to public health. Time will tell if the goals of get- ting tainted products out of the mar- ket faster and being able to determine the “root cause” of an outbreak will be met, but the ambitious goals of the FDA seem to be moving those goals in the right direction. • Bill Marler is a food safety advocate and the managing partner of Seat- tle-based law firm Marler Clark.
by BILL MARLER
A s our food supply has be- come longer — essentially worldwide — and food products have become more complex, food traceability has become the goal for manufacturers, consumers and government regula- tors. Perhaps the reasoning for trace- ability comes from slightly different perspectives, but the goals — at least as it relates to food safety — are the same. The goals are to quickly and accurately identify likely tainted products and remove them from the market, hopefully before illnesses occur, and to identify the likely “root cause” of the contamination so as to learn how to avoid the same fate in the future. The U.S. Food and Drug Adminis- tration (FDA) has announced chang- es in foodborne illness prevention through the finalization of a rule to better trace contaminated food through the food supply, whether sourced in the United States or abroad. The final rule establishes addi -
tional traceability recordkeeping requirements for those that man- ufacture, process, pack, or hold certain foods, including fresh leafy greens, nut butter, fresh-cut fruits and vegetables and ready-to-eat deli salads. In collaboration with industry, the FDA says it will be able to more rapidly and effectively identify the origin and route of travel for certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products. Foods subject to the final rule requirements appear on the Food Traceability List (FTL). To deter- mine which foods should be includ- ed in the FTL, the FDA developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act
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