KANSAS CITY — Deli cheeses, several produce commodities, fresh seafood and deli salads are among the foods that will be subjected to a more thorough traceability protocol under new proposed federal government regulations.  

The US Food and Drug Administration wants to establish additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the agency has designated for inclusion on its Food Traceability List.

The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule), is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA), according to the agency.

The proposed requirements would help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.

At the core of the proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).  While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. FDA said it will encourage the voluntary adoption of these practices industry-wide.

“(This is) an important, critical step forward in the US Food and Drug Administration’s efforts to bring about farm-to-table traceability in our food supply,” said Frank Yiannas, the FDA’s deputy commissioner for food policy and response. “When we say traceability, what we are really talking about is the ability to track food at every step of the supply chain. While limited to certain foods, this proposed rule would create a first-of-its-kind standardized approach to traceability recordkeeping, paving the way for the industry to adopt and leverage more digital, tech-enabled traceability systems both in the near term and the future.”

Building on FSMA’s foundation

Congress recognized the need for greater traceability, Yiannas said, in the FDA Food Safety Modernization Act (FSMA). FSMA section 204, Enhancing Tracking and Tracing of Food and Recordkeeping, instructs the FDA to develop additional recordkeeping requirements for certain foods to help establish clear tracing of a food product’s source when needed to address food safety risks. The proposed rule, when finalized, would implement this key component of the landmark food safety law.

“We recognize that to fully realize the public health benefits envisioned by FSMA, we need to continue to improve our ability to rapidly and accurately identify foods that may be causing illness, and this rulemaking is part of that,” Yiannas said. “When FDA Commissioner Stephen Hahn and I announced the New Era of Smarter Food Safety Blueprint in July, this proposed rule was presented as the first step in our work to advance traceability. We want to help protect consumers by more quickly identifying the source of contaminated products, limiting the scope of recalls, and reducing the risk of illness or death.”

Advancing traceability, he added, will also greatly facilitate timelier root-cause investigations to learn more about how contamination occurs in order to prevent future outbreaks.

Consumers don’t normally think of food traceability as being a means of preventing foodborne illness, Yiannas said, but like many of the improvements in food safety over the years, such as whole-genome sequencing, the proposed rule will have a direct impact on preventing foodborne illness.

“More comprehensive traceability through access to records of key data elements associated with critical tracking events in food production and distribution has the potential to help us pinpoint the exact sources of foods involved in outbreaks,” Yiannas said. “Not only does this help us to remove potentially unsafe products from the market more quickly, preventing additional illness or death, but it also helps us to conduct root cause investigations to figure out what went wrong leading to the outbreak.”

Without knowing the source of contaminated food, he added, it’s extremely hard, if not impossible, for the FDA to fully diagnose the problem and work with industry to develop and implement strategies to prevent similar issues in the future. Recent outbreaks of foodborne illness tied to fresh produce like leafy greens and papayas, he said, highlight the importance of this work.