The United States Food and Drug Administration has announced unprecedented progress in the prevention of foodborne illnesses through the development of a rule to more effectively trace contaminated food through the food supply, whether it comes from the United States or from abroad.

The final rule establishes additional traceability record keeping requirements for those who produce, process, package or hold certain foods, including fresh leafy greens, nut butters, freshly cut fruits and vegetables, and ready-to-eat deli salads. In partnership with industry, FDA will be able to more quickly and effectively identify the origin and travel route of certain contaminated foods to prevent or mitigate foodborne disease outbreaks, address credible threats of serious adverse consequences for health or death, and minimize overly broad warnings or recalls involving unaffected food products.

“This rule sets the stage for even greater end-to-end food traceability across the food system that we are working on as part of the New Era of Smarter Food Safety initiative,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “This data-driven, standardized approach to traceability record keeping helps create a harmonized and universal language of food traceability that will help pave the way for the industry to adopt and leverage more digital, interoperable and technology-enabled traceability systems. both in the short term and in the future.”

Foods subject to the requirements of the final standard appear on the Food Traceability List (FTL). To determine which foods should be included in the FTL, the FDA developed a food traceability risk classification model based on factors identified by Congress in Section 204 of the FDA’s Food Safety Modernization Act (FSMA). These foods include fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, and tropical tree fruits, as well as eggs in their shells, nut butters, freshly cut fruits and vegetables, prepared deli salads, cheeses (several from hard cheeses), fish and shellfish.

The FDA released a proposed rule in 2020 and held a public comment period where comments were received from food manufacturers and other interested parties through early 2021. In response, the agency made several changes to the final standard so that it better aligns with current industry approaches to food traceability and harmonizes the points in the supply chain where records must be kept.

Key features of the Final Rule include:

  • Critical tracking events: At specific points in the supply chain, such as the collection, chilling, initial packing, receiving, processing and shipping of FTL foods, records containing key data elements are required.
  • Traceability plan: essential information to help regulators understand an entity’s traceability program. These include a description of the procedures used to maintain the required records, descriptions of the procedures used to identify foods in the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions relating to the traceability plan and a farm map for those who grow or raise a food on the FTL.
  • Additional Requirements: record keeping as original paper or electronic records, or certified copies; provide the required records to the FDA within 24 hours of the request (or within a reasonable time agreed by the FDA); and provide records in a searchable spreadsheet when needed to assist the FDA during an outbreak, recall or other public health threat.

Foodborne illnesses affect millions of Americans every year. This action advances the agency’s efforts to better protect the public by ensuring a safe and healthy food supply. Improved record keeping requirements for FTL foods will allow for faster identification and rapid removal of potentially contaminated foods from the market, ultimately resulting in fewer foodborne illnesses and deaths.

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