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FDA Insight: Episode 24 – Transcript

Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. I hope everyone had a safe and happy holiday season, and thank you so much for joining us for another great episode.

This week, we'll be discussing FDA's new approach to the New Era of Smarter Food Safety. My guest and colleague today is Frank Yiannas, the FDA's Deputy Commissioner for Food Policy and Response.

Mr. Yiannas has a deep background in microbiology and public health. He has held multiple successive senior leadership roles, including two industry leaders in Walmart and the Walt Disney Company. Mr. Yiannas is recognized within the industry for his role in elevating food safety standards and building effective food safety management systems based on modern science in risk-based prevention principles. At FDA, he's been committed to championing a forward-leaning food policy as part of the agency's public health mission.

Mr. Yiannas, welcome to FDA Insight. It's really great to have you here.

Frank Yiannas: Well thank you, Dr. Shah. It's a pleasure for me to be on this podcast with you, but please feel free to call me Frank.

Anand Shah: Thanks. And likewise. Well, let's jump right in. What is the New Era of Smarter Food Safety? And why is this important to consumers?

Frank Yiannas: Well, that's a great question. Let me begin with the why. I really like that you started with that, because the why really is the antecedent to all the actions that a person or organization might take. The reality is, Dr. Shah, that the food system has been changing from the beginning of time. If you pause to think about it, at the beginning of time, man was ... and I use the term “man” effectually to refer to both genders. Man was mainly a hunter-gatherer, would bring food home. Shortly thereafter, we started to see villages forming around water and the domestication of plants and animals. If you fast forward to the early 1900s, you had the industrial farming revolution. And where we find ourselves today is in the modern food retail environment, where consumers can go into a grocery store and literally find anywhere up to 50,000 different food items.

The truth is, Dr. Shah, that the food system is continuing to change. And in fact, some are predicting that we will see more changes in food in the next 10 years than we saw in the past 20 or 30. As we speak, foods are being reformulated, there are new foods and new food production methods being realized, and the food system is increasingly becoming digitized. We also know that our ability to detect foodborne illnesses is getting better than it's ever been before.

And so at FDA, we believe that these modern times required more modern approaches. And that's why we're talking about a New Era of Smarter Food Safety. What it is is actually a new approach, if you will, or a new mindset on how we're going to tackle the remaining food safety issues that exist in society today. It's largely what I call people-led, a New Era of Smarter Food Safety is going to have to be required to be led by smart men and women working in the food industry and FDA. It will continue, for the FDA, to be FSMA based, in the rules and regulations that we have in place called the Food Safety Modernization Act. But we believe it will increasingly be technology enabled. So, a New Era of Smarter From Safety is people-led, FSMA-based, technology enabled.

What we want to do is just many sectors of society have these new tools, new approaches and new and emerging technologies to solve business problems; we want to do the same to solve food safety challenges. And so, we've set out a blueprint or a vision on how we'll further modernize our approaches over the course of the next 10 years. Some of your listeners will know that literally almost 10 years ago to this day, Congress passed the Food Safety Modernization Act, the most sweeping reform to our nation's food laws. What we want to do is build on that, because modernization isn't something you can do simply once a decade. And so we've created another decade – a view of how we're going to advance food safety, but with this new mindset, leveraging new and emerging technologies. And we're calling this this new era of smarter food safety.

Anand Shah: Frank, you describe an increasingly complex universe related to food and food policy, and accordingly, the goals of the blueprint encompass several complex topics such as new business models, improving predictive analytics and enhancing traceability. Will these changes make the process even more complex?

Frank Yiannas: Now, that's a good question. The reality is they will not. They'll make them more effective, more efficient. And let me give you two examples. In the blueprint we have a host of ideas, they're broken down into four of what we call core elements. Number one is enabling food traceability through technology; the idea that we want to trace things back to source quickly in the event of a food scare, and just create greater transparency in the food system, knowing that transparency is a powerful motivator for guiding people to self-observe behaviors. The second area in our blueprint is what we call smarter tools and approaches to prevention. We have a third section that we're calling new business models as the food system continues to change. And the fourth one is an area called food safety culture, realizing that in addition to technology, you have to influence and change human behavior for the better.

But let me give you two examples of things we've already started doing that will illustrate that this new era approach will actually simplify and make things more effective and efficient. First one is through traceability. Right now, if there's a food outbreak and you want to trace foods back to source, it's pretty difficult, because the food system is distributed, decentralized, and food traceability records today are largely kept on paper. And so if you have to trace back of food, let's say a lettuce product, you literally have to go to various points in the chain and collect paper records and try to piece that together. And that can be very labor-intensive.

But one of the things I did, Dr. Shah, before I joined the agency and private sector, I did a proof of concept or a pilot using a new technology called distributed ledger technology, blockchain technology, and wanted to see if we started capturing food traceability record in a distributed ledger in a very simple user fashion with very simple apps that farmers and processors could use, could we speed that?

And so let me give you the life story of a mango to illustrate how we did that. Mangoes, when they're planted in seedlings into the ground, they take eight to nine years to mature and bear fruit. Those mango seedlings then become the large trees that are bearing fruit. Small farm crews will go out and pick those mangoes, they'll send them to a packing house. From the packing house, at least in this hemisphere, they're grown in Central and South America, so they'll get shipped by air, land or sea to the United States. They then go to further processing in the US. By the time they make it to a consumer's dinner table, there's a lot of hands that that mango has gone through. I called it the life story of a mango. I wanted to see, if you used today's system, how long does it take you to trace those mangoes back to source?

And so I challenged a team working at a retailer to trace back those mangoes, and it took them six days, 18 hours and 26 minutes to trace those mangoes back to source. The proof of concept that we completed using distributed ledger technology ... and by the way, it was very simple to capture the information off the time signatures, scanning a package. I did a proof of concept and scanned a package of sliced mangoes and was able to trace those mangoes back to source in 2.2 seconds. Seven days to 2.2 seconds. The process was not only more efficient, more accurate, and more precise, but it was easier to perform. And so that's an example where this new era approach could simplify things and make them better. And that's good for consumers.

The other example I'll give you is on imported foods. You know, Americans want their foods to be safe, regardless of whether they're domestically produced or imported from abroad, and the reality is I think a lot of people think that Americans eat a lot of imported food. Our estimates are that about 50% of all food consumed in this nation comes from abroad, although it's much higher in certain categories, such as seafood. While the FDA does a very thorough job of working with foreign governance to make sure that they meet our standards, we certainly do foreign inspections, but once those food items start hitting US ports, we have a process where we screen those food items to do testing and screening to make sure they meet US standards. Well, again, wanting to use this new era approach, what we did in a proof of concept last year is we said, "If we overlay our current processes and technologies that we use today with a new and emerging technology called machine learning, can we strengthen and make our work more efficient?"

And what our proof of concept showed, Dr. Shah, is by leveraging this technology of machine learning, scanning all of the data that we acquire through these food imports year after year, and making the risk prioritization a little bit more dynamic and using the power of statistics with the computing power that exists today, we showed that we could potentially increase our ability to find violative products by 300%. Let me repeat: 300%. That's a whopping increase.

So again, by leveraging technology what we've done is we we're allowing FDA inspectors to be looking at those food shipments or containers that are most likely to be violative. And so, I hope that those two examples illustrate the power of new and emerging technologies and how they can make things more effective and efficient.

Anand Shah: That's really great, Frank. I really enjoyed your example of mangoes here, my favorite fruit. And let's take a deep dive into two current events which I think are near and dear to many of our listeners and consumers. I mean, as we both know, the COVID-19 pandemic has had a tremendous impact on our food supply chain, and has the potential for an even greater disruption. What is the impact of the new era blueprint on our current COVID-19 response and for future health emergency preparedness?

Frank Yiannas: Now, that's a great question. Let me just pause and emphasize to the listeners, I think they know; the virus that causes COVID-19 is not known to be transmitted by food. It's a respiratory virus. Nevertheless, as you suggested, the pandemic has had an effect on the food system, largely through ill food workers. And if you start halving your workers, it affects your ability to produce, and food operations, farms and processors and deliveries to operate at normal capacity. And so at the beginning and at the height of the pandemic, what we saw as we asked consumers to shelter at home, we saw them go to grocery stores and load up, buy more groceries than they normally would, and so we saw a lot of outages with center of the store type items.

Shortly thereafter, as restaurants and hotels and theme parks closed, what we saw was not a lack of food, not a food supply issue, but supply chain logistics issue. There was too much food, Dr. Shah, simply in the wrong places, and so the FDA worked with growers and manufacturers to allow those foods to get diverted to grocery stores so that they could reach consumers. And the pandemic has, without question, had an impact on the food system.

Now, I've always believed, having worked 30 years in the private sector, that the U.S. food system is one of the best food systems in the world, but we just experienced what I would describe as the biggest test on the food system in 100 years. We passed the test. Did we pass it with flying colors? No. Did we score an A plus? No. But if you pause to think about it, even at the heights of the pandemic, what we were seeing is consumers could still go to their favorite grocery store and find tens of thousands of different food SKUs or food items available for a fraction of their hard earned dollar. So, we passed the test.

But it has revealed what I would call vulnerabilities in the food system. And I believe that one of the silver linings of this event for food is that we're going to learn how to make the food system even stronger and more resilient than ever before. But in the blueprint, we have been working on this since last year, we were on the verge of unleashing the blueprint earlier in 2020, and then the pandemic hit and we had to put it on pause. And what we see now is that so many of the things that we wanted to do in the blueprint would be useful in the time of crisis, like the COVID pandemic, and they'd be useful in times of not being in a crisis.

I'll give you a few examples. One, we know that we want greater traceability and transparency in the food system. When we saw the early types of imbalances that existed and that I mentioned, too much food in the wrong places, clearly having a more digital and traceable food system would have been very useful to make sure that we could get that food to the right places as quickly as possible, knowing that food is a perishable product. So, in hindsight, the work that we want to do under new era would be very, very useful in a time of a crisis.

Another example is in the blueprint we've talked about wanting to do virtual remote monitoring. We had identified this long before the pandemic. The pandemic hits, people want to protect workers, and we had to implement virtual and remote inspection processes. Again, hindsight 20/20, realizing that this virtual and remote way of working would have been useful during the pandemic.

And then a third example I'll give you is in the blueprint I mentioned that there's a core element called new business models. One of the things we wanted to work on, we realized that the way consumers are buying food has changed. In fact, it was projected that one out of every $5 spent on food would be done online in the coming years. What the pandemic did was blow those statistics out of the water as more and more consumers stayed at home and ordered foods online. And so, again, illustrating that our vision of creating a food system that addressed all of the different ways consumers might access food would be beneficial.

And so I will tell you that the new era blueprint will be invaluable at all times, but especially needed in times of crisis.

Anand Shah: That's great. And Frank, it seems every year we hear in the news that there's another case of foodborne outbreaks of e-coli, and more specifically Shiga toxin producing e-coli, with a confirmed or suspected link to leafy greens. How will the new era blueprint safeguard Americans from tainted leafy greens? Or in other words, what impact will the blueprint have on these types of outbreaks?

Frank Yiannas: Yeah, that's a good question. Let me begin by providing a little bit of context. The reality is that every day, literally every day in this country, millions of portions of leafy greens are consumed safely, every single day. Having stated that, as you've mentioned, we've seen over the past several years that when outbreaks do occur at times, maybe too frequently, they are implicated with fresh leafy greens. And we've seen this pattern repeat itself, seasonal, year after year. At the FDA we are of the belief that one foodborne illness is one too many, and so we will continue to work on accelerating prevention.

For leafy greens in particular, Dr. Shah, there's a couple of initiatives that are intersecting. One is the Food Safety Modernization Act that I mentioned, and we've developed a produce safety rule. There's still some additional work to do under the produce safety rules, specifically with an ag-water standard that we're proposing. We also, in 2020, as a result of these repeat nature outbreaks, we developed what we call an STEC Leafy Green Action Plan that identifies work or commitments on actions that we'll take along with the industry to further strengthen leafy greens.

But the new era in particular, as you mentioned, will be useful as well, and I'll give you two good examples, one under the new era. And when we talk about new and smarter approaches, we want to strengthen what we call root cause analysis, which means when these outbreaks happen, we have to thoroughly investigate and get down to the root causes or contributing factors so that we can truly understand why they happen and better inform prevention so that they don't happen again. And one of the ways we best do that is by further advancing traceability, as identified in the blueprint. The reality is trace backs today, remember the mango example, six days, 18 hours, 26 minutes; that's too long. And when there's a food scare or food problem, what you want to do is trace back quickly so you can get boots on the ground and really understand what went wrong so that you can correct those things, inform industry and prevent them from happening again.

So, I would say tech enabled traceability under the new era and root cause will be game changers that will ultimately allow us to further strengthen the safety protections for fresh leafy greens.

Anand Shah: Well, Frank, this is great. It's time to wrap it up, and I really want to thank you for taking the time to join us this week on FDA Insight. This has been an incredible update on the latest on food policy at FDA. Thanks to you and your team for keeping Americans educated on these issues, and of course safe.

Frank Yiannas: Well, thank you. I've enjoyed participating.

Anand Shah: In the weeks ahead we'll be covering a variety of topics that are important to public health. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow.

Again, we all hope you had a wonderful holiday season and wish a great start to your new year.

We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcasts or Google Podcasts. We're also on Spotify and Pandora, so whatever platform you're on, thanks for listening.

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