When it comes to food, traceability equals safety. On the USDA side, the agency continues to look for ways to enhance the traceability of meat and poultry products. On the FDA side, the agency is now also recognizing the benefits that enhanced traceability can provide.

Last fall, FDA published a proposed rule titled "Requirements for Additional Traceability Records for Certain Foods" (“the Rule”). Under the new Rule, FDA proposes to: (1) identify and itemize high-risk foods; and (2) establish enhanced traceability requirements for those foods. By mandating and standardizing new traceability records for high-risk foods, FDA hopes to facilitate rapid and accurate traceability, thus preventing or mitigating foodborne illness outbreaks.

The list of high-risk foods can be found in the FDA’s Food Traceability List. The list is expansive, including, among other foods, shell eggs, all types of fresh-cut fruits and vegetables, all types of leafy greens, nut butters, ready-to-eat deli salads, and all soft cheeses. The list was generated using a risk-ranking model that focused on immediate public health risks such as biological hazards and acute chemical toxins. More specifically, the list took into account, for each high-risk food, the likelihood of contamination, the frequency of outbreaks, the severity of potential illnesses, cost of illness and other criteria.

The Rule (if implemented in its current form) would require companies that manufacture, process, pack or hold foods on the Food Traceability List to establish and maintain certain traceability program records. Specifically, it would require all companies to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). CTEs include growing, receiving, transforming, creating and shipping. The required KDEs would vary depending on the CTE.

Additionally, all companies will be required to provide FDA with an electronic, sortable spreadsheet containing relevant traceability information within 24 hours of a request during outbreaks, recalls or other public health threats. This would include a description of how traceability lot codes are assigned, a description of relevant reference records, and any other information needed to understand the data within the traceability records. In terms of accessibility, the proposed rule would also require that all underlying traceability records be made available to FDA as soon as possible, but no later than 24 hours after a request is made.

While the proposed requirements would apply only to foods on the Food Traceability List, FDA is encouraging all companies to uniformly adopt these practices. If a Final Rule is published — and implementation unfolds smoothly — it would not be surprising to see FDA continue to broaden the categories of products that would be subject to the rule. The period for public comment on the proposed rule is closing on Feb. 22, 2021.

As traceability continues to improve, the original source of more outbreaks can likely be determined, and more outbreaks and/or illness can likely be stopped. As the new Rule is implemented, we look forward to seeing if it will, in fact, prevent illness and save lives.

New traceability rule coming soon

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