April 13, 2021

FDA Proposes New Traceability Rule For Food Manufacturers

The FDA is proposing a new traceability rule for food manufacturers, as well as those who process, pack or hold foods on the Food Traceability List to help identify recipients of those foods quickly to help mitigate foodborne illness outbreaks. In the past few years, the government has blamed their inability to find the sources of foods that have caused outbreaks on traceability issues. This rule would be part of the Food Safety Modernization Act of 2011 (FSMA).

FDA Proposes New Traceability Rule For Food Manufacturers

The proposed rule is called Requirements for Additional Traceability Records for Certain Foods. It is a key component of the FDA’s New Era of Smarter Food Safety Blueprint. The comments periods for the proposed rule and information collection provisions have been extended until February 22, 2021.

The rule would be a requirement to create traceability lot codes for anyone who manufacturers, processes, packs, or holds foods. Those facilities would have to establish and maintain records containing Key Data Elements associated with different Critical Tracking Events. These requirements would only apply to foods on the Food Traceability List, but the government says they are suitable for all FDA-regulated products. The government is encouraging the voluntary adaptation of these practices industry-wide.

The food traceability list includes, broadly: cheese other than hard cheeses, shell eggs, nut butter, fresh cucumbers, fresh herbs, fresh leafy greens, fresh melons, fresh peppers, fresh sprouts, fresh tomatoes, tropical tree fruits, fresh cut fruits and vegetables, finfish, including smoked finfish, crustaceans, mollusks, bivalves, and ready-to-eat deli salads. There have been multistate food poisoning outbreaks in the past few years related to most of those foods.

Those foods on the list were identified by using a risk-making model for food tracing. The tool scored commodity-hazard pairs according to frequency of outbreaks, severity of illness, likelihood of contamination, growth potential, manufacturing process contaminating probability, consumption, and cost of illness. A commodity was included on the list if its risk score, aggregated across all hazards, was 330 or higher. You can see the table for Criteria and definitions, along with the table for designating risk scores, at the FDA web site.

The compliance date for all covered entities would be two years from the date the final rues becomes effective. The FDA wants the new traceability rule to be effective 60 days from the date when the final rule is published in the Federal Register.

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