New Draft Traceability Rules Under FSMA

FDA is currently working to draft a proposed rule under Section 204 of the Food Safety Modernization Act (FSMA). Taryn Sjursen Webb, health communications specialist for the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), noted the agency is using the findings from the Institute of Food Technologists’ product tracing pilot proj­ects, feedback from the draft approach for developing a high-risk foods list, and related information FDA has learned about traceability to draft the rule.

“We anticipate sending the proposed rule to the Office of the Federal Register by Sept. 2020 and doing the same for a final rule by Nov. 2022,” she said. “After the FDA publishes the proposed rule, the agency will hold three public meet­ings during the comment period to provide stakeholders the opportunity to provide feedback before finalizing.”

In the meantime, FDA released the 2020 Leafy Greens STEC Action Plan March 5, outlining steps the agency plans to take this year to advance the safety of leafy greens. Specifi­cally, one of the steps the plan mentions is the proposed rule for implementing FSMA Section 204 related to the records required for tracking and tracing designated foods, which may serve as a foundation for traceability throughout the entire food system. It also included intent to prioritize work with leafy green stakeholders to design and initiate a pilot on concepts needed for traceability, such as testing interop­erability of tracing systems and public-private data sharing.

A Need for Modernized Traceability

When it comes to food traceability, many in the food system have traditionally utilized a largely paper-based system of taking one step forward to identify where the food has gone and one step back to identify the source. This makes it chal­lenging to quickly and effectively trace product through the supply chain.

FDA recognized to fully realize the public health benefits envisioned by FSMA, it needed to improve its ability to rap­idly identify the source of foods that may be causing illness. Frank Yiannas, the current head of food safety at FDA, has said repeatedly traceability is a huge priority for both FDA and the food industry, calling lack of traceability a “major Achilles heel” of today’s food system.

“Part of our work right now is developing and issuing the proposed rule that is required by FSMA 204, but we are also exploring ways that we can use new and emerging tech­nologies that may help us trace the origin of contaminated food to its source in minutes, rather than days or weeks,” Webb said. “To help accomplish this goal, our New Era of Smarter Food Safety Initiative will explore opportunities and specific actions to evaluate new technologies and upgrade our abili­ties to rapidly track and trace food through the supply chain.”

Sarah Sorscher, deputy director of regulatory affairs for the Center for Science in the Public Interest, noted this work is critical to enable the public health investigators to trace outbreaks of foodborne illness back to the source and issue targeted and swift recalls.

“Traceability is also vital to identify the root causes of con­tamination and develop protective measures that will ulti­mately prevent the next outbreak,” she said. “Lack of trace­ability has repeatedly hampered investigations of outbreaks linked to leafy greens, where investigators have been unable to identify the source of contaminated food, leaving them with no other option but to issue broad public warnings against eating any lettuce grown in particular regions of the country. Better recordkeeping by industry will dramatically improve the chances that outbreaks are solved.”

Being Prepared

Sorscher explained the standards will apply only to certain foods specifically identified by the FDA as high priority, but there won’t be an exact list until the rule is proposed in September.

While the FDA cannot require a specific technology, Sorscher noted that meeting the standard will likely require numerous companies to update their systems in order to maintain more streamlined and consistent records than they have in the past. The elements may include, for example, the harvest location and harvest date (for fresh produce), and unique company and product identifiers based on a widely adopted standardized system.

Several industry groups have developed recommendations for further progress.

For instance, the FMI: The Food In­dustry Association put together a guide recommending food safety best practices for leafy greens, which includes suggestions for traceability and capturing key data elements for leafy greens.

Additionally, United Fresh Produce Association and the Produce Mar­keting Association released their recommendations for traceability through the Romaine Task Force, which also emphasized the need to capture consistent data elements as products move through the supply chain.

Webb suggested now is the time for companies to look at how they can improve their own ability to track and trace their products and ingredients through the supply chain.

“Very soon, FDA will be releasing a Strategic Blueprint for the New Era of Smarter Food Safety, which will explore how industry can leverage technology to improve their traceability systems and what we can do as regulators to improve traceability throughout the food safety system,” she said.