Frank Yiannas, former FDA deputy commissioner of food policy and response, continues to help advance food safety and the implementation of the Food Safety Modernization Act now as a strategic adviser with Wiliot.
Using ambient Internet of Things technology, Wiliot’s battery-free wireless platform can attach to any food product or packaging and provide case-level information about location, temperature, carbon footprint and more real-time data.
Finalized in November 2022, the FDA’s FSMA Rule 204 rule will require the food supply chain by January 2026 to trace food at each step throughout the entire supply chain, and Yiannas believes Wiliot will provide an important link.
Agri-Pulse talked to Yiannas about lessons learned in the industry, his new role and changes needed at FDA. His answers have been edited for length.
Q: You’ve spent the first 20 years of your career at the “happiest place on earth” and then the “busiest place on earth” and during different administrations at the Food and Drug Administration. What lessons have you learned from a lifetime working on food safety?
I spent the first 20 years at Disney, then Walmart for 10 years, the world's largest company. ... The Disney company is all about striving for excellence in detail. Details matter in food safety. ... The other thing I learned at Disney is this focus on people. The reality is that to make these types of technological innovations, they have to be people-led, technology-enabled. And Disney was great at that. It was Walt Disney who said, ‘You can dream, create the most magical place on earth but it requires people to make it happen.’ And so, I'm a strong believer that we need people in leadership to create a safer, smarter food system, and you need experts, too.
My first day on the job at Walmart, I made a decision to pull all Roma tomatoes because I arrived during the summer of salmonella. And that decision, first day on the job, was a $6 million decision. You quickly realize that at Walmart, everything is about scale, and you have to solve problems differently at scale.
If you really want to make the food system safer, you have to design it into the system, and design it into the processes and you just can't write rules or regulations. System safety begins with design. So that was one of my real big takeaways.
The other thing, when you work for an organization that has 2.2 million people, you quickly realize that what's complicated just doesn't get done. And one of the things we'll talk about with the Wiliot solution is that it's simple to use. We're not talking about people having to do a lot of labor, scanning a lot of cases.
Q: During your time at FDA, you oversaw the execution of the Food Safety Modernization Act, which is not fully implemented after over a decade. Where did you see implementation challenges and where are opportunities for continued cooperation for more food safety benefits?
I think Congress had it right in 2011. We had some big food scares in our nation ... and all of these things led up to Congress and consumer groups and industry saying, “Enough is enough. Let's try to make this food system safer." And Congress had it right when they said, "Hey, FDA, it's not enough to simply respond to outbreaks." The congressional mandate was: FDA, you have to do more to help industry prevent them from happening in the first place.
And FDA was given mandates ... (but the agency) got off to a slow start. There were three lawsuits against FDA for not writing these FSMA rules fast enough. They settled on the first two lawsuits, as you know. And then that third lawsuit was around food traceability, something that we're going to talk about with Wiliot. FDA just hadn't gotten around to writing it. And when I went to FDA, one of the reasons I wanted to go is my passion for creating greater food system transparency. So, I went over there, and the first capital that I spent was working with our chief legal counsel and working with HHS to say, "Let's settle this lawsuit. And let's get on with writing the rule."
In hindsight, I think there's things they could have done differently organizationally to get it done. A lot of the FSMA funding was front loaded. I think we just didn't have the right experts in place. It's taken way too long, in my opinion. I think congressional leaders feel it's too long, and consumer groups feel like it's taken too long.
There are two rules that I think are very targeted, and these are the game-changers. One is on ag water. ... In 2022 we issued a new ag waters standard. Now FDA has to finalize that. I'm hopeful. I'm very hopeful. I don't have insights now, but I'm hopeful that it can be finalized this year because we left it in a very good place. But when that gets finalized, that's a game-changer for food safety prevention. Because so many of the outbreaks that we're seeing these days are produce-related. And water is often, but not always, a conduit to those contamination events.
The second one is the food traceability rule. I'm a big believer that this is a game-changer. ... We got this final food traceability rule that's going to be in front of us very quickly. January 2026 is right around the corner. If you look at the FDA outbreak table right now, they're investigating all kinds of outbreaks. Sometimes the food sources are unknown. Why is that? Because we don't have transparency.
Q: You’re now serving as a strategic advisor at Wiliot, an Internet of Things platform that can help food and retail markets meet the traceability requirements of FSMA. How do you see this technology transforming the data requirements for the FSMA traceability rule?
After I left federal service, I started engaging with Wiliot, and I think the beauty of this solution is that it achieves what I think is really the endgame here. It's not just tracking and tracing the foods, which the FDA rule does and that's good. There's a return on investment by just better tracking and tracing food sources for safety reasons alone: preventing illnesses, reducing the burden of possible hospitalizations, deaths, lost time at work.
But the real benefit is when you can go to track, trace and monitor. ... You move beyond the track and trace, and you can monitor it, and it's going to soon allow us to start changing the paradigm. You don't always have to test the food, and you don't always have to go into a facility to inspect because now we're getting real-time data at different points in the food system. And it doesn't mean that we're going to replace that gold standard of going in person.
The analogy I like to use is how I change the oil in my car. In the old days, I changed it every three months or every four months. Do you know when I change the oil now? When my vehicle tells me I have to change the oil because there's monitoring and sensing.
And then the second thing is one of the big Achilles heels – is to get it to food service providers and retailers. ... I ran the foodborne outbreak investigation team at FDA for four and a half years. I can tell you outbreak after outbreak, one of the real missing gaps is that last mile. We know the consumers that get sick, but we can't really link it to the foods that they may have purchased or consumed because retailers and food service companies don't have traceability records.
Q: Your new position also builds on your long work of integrating blockchain into food supply chains. As we improve the capability to trace contamination back to farms, does this change the legal liability for growers? How will this impact growers of different sizes?
I don't chase technologies. What I do chase is public health problems. And if there's technologies out there that can help solve them, then that's what I'm going to be focused on.
I actually don't think it creates liability for producers. I think it will reduce liabilities by knowing the truth. And then one of the big things that it fixes is it creates a shared value. ... I think small and medium enterprises are going to come in because they're going to say, "Hey, it's going to allow me to get to the truth and sometimes it won't be my problem." If there's a recall and all romaine is getting pulled and my livelihood suffers when in reality sometimes after two weeks of products being off the shelf, it’s that's one producer, one day's production, one lot number and an entire industry has been devastated.
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If there's reservation or hesitation now, I think in time people are going to come around and say, "I’m balanced. This doesn't add risk or cost the food system." It eliminates risk and provides safeguards for the people that are doing things right. And ultimately, I'm absolutely convinced it'll lead to efficiencies. It'll take costs out of the food system at a time when inflation is soaring.
Another new role for you is an advisor position with the Western Growers Association's science team on its data sharing project, GreenLink. How do you see new technologies and data collection capabilities transforming and improving the food safety efforts by those in the market as well as regulators?
The project that we're doing with Western Growers is getting different growers to collaborate and share their data anonymously, with the hope that everybody's data allows the whole system to get smarter together, and we might uncover some questions that we don't know we need to be asking or see some trends that we can't see with one company's data alone.
The way I think it fits into what we're doing with Wiliot is that at the end, we can capture data. One of the challenges still in this distributed food system is the willingness of participants to share data. When we get to working on the technology problem and capturing data in a super user-friendly, low labor model, it's not just technology alone, there’s social aspects of how food companies work together.
I'm working on data sharing so we can create new models, proof of concept success, that companies can share data anonymously so they can get better and stronger together. In reality, when it comes to safety, they kind of win or lose together, right? And then we're bringing along the technologies to facilitate this happening.
A lot of attention was directed at FDA this year at efforts to transform the agency’s culture, especially during COVID and the infant formula crisis. You resigned in January before any specific details were revealed on proposed agency changes. Do you see the challenges facing FDA as structural, cultural or both?
During my tenure there we had a revolving door of commissioners. I had six bosses in four and a half years. The commissioner job is a tough job. But I do think that the organizational structure at FDA would be served better by having one truly empowered food expert. I think you hear what Commissioner [Robert] Califf saying is that they're moving in that direction.
Organizational structure matters. But as I also said, and I've had these conversations with all of the commissioners that I work for, is that strategy precedes structure. We need to have a real cohesive modernization strategy for the nation. Up until recently, it was food safety modernization. I think food safety modernization is a framework of rules, but we need to continue to modernize.
And I hope that FDA comes out with a more articulate strategy of what they want to achieve in the future. We did that during my tenure with the New Era of Smarter Food Safety’s four core elements. Strategy precedes structure. You need organizational structure. Structure is critical. But before those two comes organizational culture. And there's some work needed as well at the FDA in the organizational culture.
There's some great men and women that work there. But I think the public sector and agencies such as FDA would be well-suited by bringing in some of the corporate governance models of how to get things done a little bit more efficiently, a little bit quicker. There's reasons why things go slower in government. But there's also ways that they can work faster.
Some practices of the corporate sector that could be brought over to the public sector is attention to metrics. Government is not really so focused on outcome metrics. And I think real focus on outcome metrics, and even the leading indicators, I think FDA could do a better job on measurements.
Q: Congress is tasked with finalizing a budget for FDA in the months ahead. Do you believe Congress should allocate more funding for FDA? How can the agency be a better steward of the taxpayer’s money?
We all saw what happened to the credit rating here in our country. Using taxpayer dollars for our public health and just federal service missions is critical. We have to use them wisely. When I left, we had about a $1.4 billion budget for food. The agency is a big institution, most of the money goes to the drug space, and $1.4 billion, which is sizable, it's not anything to sneeze at.
The phrases that we get trained really well at FDA when we’re in front of Congress we’ll say, "Hey, we can always do more with more." That's true, right? If you give us more money, we can do more. But I do have my private sector guiding principles and beliefs, which is I can never go to the CEO of a company and ask for more money unless I can prove and demonstrate that I was doing a really good job with the money I was being allocated.
I think both things need to happen here. I think Congress needs to demand a good explanation. There needs to be a good accounting of the $1.4 billion and how it's being spent on food. When that's done, and we make sure we're using that very wisely, yeah, I would expect that there's more that we can do with additional funding, but both need to happen.
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