September/October 2024

No time to waste: Company scaling up food safety solution
By Melinda Waldrop, Managing Editor

The way Frank Yiannas sees it, there’s no time to waste.

Yiannas, former deputy commissioner of food policy and response for the Food and Drug Administration, has joined cutting-edge efforts to help providers and processors comply with imminent changes to federal regulations aimed at making the nation’s food supply safer.

Last August, startup Internet of Things technology (IoT) company Wiliot tapped Yiannas as a strategic advisor to help educate retailers and food producers on how the IoT can ease and speed compliance with the FDA’s Food Safety Modernization Act (FSMA) Rule 204. The rule, which has a January 2026 compliance deadline, focuses on tracking food at each step across the supply chain to enhance visibility and enable a better response to foodborne illnesses, contamination and other public health issues.

Frank Yiannas

Persons who manufacture, process, pack or hold foods included on the Food Traceability List (FTL) must maintain records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs) and be able to quickly provide information to the FDA.

Yiannas, who helped create the federal legislation during his FDA tenure, knows firsthand how crucial increased traceability is. He resigned from the FDA in January 2023, citing the FDA’s response to 2022’s nationwide infant formula shortage.

In his resignation letter, he told FDA Commissioner Robert Califf that the previous structure of the foods program “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”

The federal agency announced sweeping structural changes to its Human Foods Program, including a restructuring of the Office of Regulatory Affairs, last year.

That top-level view left Yiannas, also Walmart’s former vice president for food safety, convinced of the need to shore up food production and distribution — and fast.

“Most people are talking about food traceability in the context of regulation, but a lack of visibility, transparency and traceability in the food system is what I’ve described as an Achilles’ heel,” Yiannas told Produce Processing. “We have some great food companies and great systems in place, but the Achilles’ heel is when a crisis happens, we just don’t really know with specificity, accuracy, precision and speed where the contaminated food came from.”

Wiliot’s Visibility Platform utilizes Wiliot IoT Pixels, mass-manufactured, postage stamp-sized devices affixed to products and packaging. Photos courtesy of Wiliot.

Accessible tech

That’s where Wiliot hopes to make a difference. Wiliot’s Visibility Platform utilizes Wiliot IoT Pixels, mass-manufactured, postage stamp-sized devices affixed to products and packaging, such as a crate of tomatoes. The pixels transmit real-time information including location, temperature, carbon emission and humidity sensing, to the Wiliot Cloud via standard Bluetooth devices.

Wiliot has taken steps to make its technology easier and faster for users, partnering with food safety product development company Trustwell and its FoodLogiQ platform, as well as food traceability platform iFoodDS, to enable a no-labor option for automatically capturing CTEs.

The supply chain management software, tailored to FSMA 204 compliance, will help make Wiliot’s technology scalable for smaller users, according to Steve Statler, Wiliot chief marketing officer.

“We recognize we can provide the no-labor generation of these Critical Tracking Events, but that’s really just part of the part picture,” Statler said. “What you need is a spreadsheet. To go beyond compliance, you need a solution. Our strategy is to have an open platform that works with apps.”

On Aug. 20, the company unveiled Wilibot, a generative artificial intelligence chatbot. Wilibot connects Wiliot’s pixels to a Large Language Model, which facilitates general-purpose language generation and other natural language processing tasks. Through Wilibot, companies can “talk” to their products, ask questions and analyze data, and then take corrective action if, for instance, produce has been handled at unsafe temperatures.

Select Wiliot customers have begun piloting WiliBot, with a broader rollout scheduled to launch later this year. Wiliot envisions consumers eventually using the technology in store and at home through the mobile apps to improve their shopping experience.

“Humidity and temperature sensing are key to reducing the number of times you go home with something that’s bad,” Statler said.

Currently, Statler said, produce is bred for resistance rather than flavor, leading to too-frequent substandard quality of products such as strawberries, which “don’t come built with ‘nature’s wrapper’ like bananas or oranges,” he said. “It’s more important to save lives, but my personal crusade is to get a decent strawberry that lasts more than five minutes.”

Wiliot has taken steps to make its technology easier and faster for users, partnering with food safety product development company Trustwell and its FoodLogiQ platform, as well as food traceability platform iFoodDS.

As Yiannas learned more about the technology driving such ambitions, his interest in working with Wiliot grew.

“I thought, this technology will not only help companies comply with food traceability, but it will go way beyond regulatory compliance and add value to the food system,” Yiannas said. “(It will) provide the type of enhanced visibility that we needed in the midst of the pandemic, when we weren’t sure where foods were — a type of technology that literally would light up where every case was at any moment in time so you could divert products where they needed to be.”

Statler didn’t expect to get Yiannas to agree to work with Wiliot.

“It’s a bit like you go to a Rolling Stones concert and then Mick Jagger says ‘Hey, do you wanna come up on stage and play with us?’” he said. “Frank, obviously because he was instrumental in creating the (FSMA 204) rule, has helped us understand how we fit and what we can add and where we need to work with others.”

Imminent importance

The January 2026 compliance deadline is “an aggressive timeline,” Yiannas said. “Companies are making great inroads and great strides. I talk to a lot of companies every day. What I’ve concluded is that I’ve seen more changes on food traceability in the past year alone than I have in the past 10.

“I am very hopeful that by 2026, a lot of companies will be in compliance, and those that are remaining — I can’t put a percentage on it — will get there shortly thereafter.”

While Yiannas doesn’t expect the FDA “to come out in January 2026 issuing warning letters requiring compliance,” he said improving food traceability should remain a top and timely priority.

“I don’t think now is the time to slow down. Now is the time to stay the course and accelerate,” he said. “It might be that it will take some a little bit longer than 2026, but I think we’re well on our way. The train has left the station.”

A recent recall of cucumbers because of potential salmonella contamination underscored Yiannas’ concern. In the early stages of investigation, the FDA website listed the outbreak source as “unknown” — a lack of specificity also notable during a 2023 listeria outbreak linked to leafy greens, when the FDA “had to advise all consumers nationwide to avoid all romaine, because we didn’t know what was the source of the contaminated romaine,” Yiannas said.

“So while I want everybody to focus on trying to comply with Section 204 by January 2026, the reality is better food traceability can’t wait,” he said. “We have to create more transparency in the food system to protect the public.”



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