The FDA’s FSMA Section 204 Architect Frank Yiannas

Transcript

• Steve Statler 00:00

  Welcome to the Mr. Beacon ambient IoT podcast. This week's episode is all about IoT and food safety. And timing. Timing is critical, whether you're telling a good joke, starting a company, or leading a social movement. And very often that timing is a function of converging forces. And that really, is what we're seeing with the adoption of Internet of Things technology, as a way of streamlining the compliance with a federal regulation is being enforced by the Food and Drug Administration. So there's a lot to learn. And very fortunately, we've got the architect of the FSMA 204 regulation with us, Frank Yanis. He's got an amazing career, we'll be talking about it. But Walmart, Disney, Deputy Undersecretary of the FDA, when I was interviewing him, it felt a bit like that same feeling that you have, if you've ever listened to music, you have a favorite artists to favorite album, and then through some miracle, you get to meet them. That's kind of how I felt today. Meeting with Frank, I've spent a lot of time digging into FSMA 204. Because I think it is so important to the adoption of Internet of Things, technology at a scale that's never been achieved before, with a set of benefits that have never been realized before. So I hope you enjoy this extensive conversation with them. We really cover a lot of bases, it should be very educational as well as fun. And Mr. Beacon ambient IoT podcast is sponsored by Wiliot, bringing intelligence to every single thing. Frank, welcome to the podcast. It's a real pleasure and an honor to have you on our show.

  
  

  Frank Yiannas 02:03

  Thank you, I'm delighted to be spending a little bit of time with the states.

  
  

  Steve Statler 02:06

  I think some people may kind of scratch their head a little bit about why are we talking about food safety with the guy that's the architect of the most significant food safety regulation, that the United States the safe. Why have that other than it's a chance to get have you on the show. But I think it's worth just saying a few things about that. And we'll we'll actually come back to it in a little bit in more depth. But you know, technology doesn't work in a vacuum. And there's some big problems there. And, you know, meaningful application occurs when, when you have a big problem, and you have a new technology, and very often, and I think IoT at times has been a technology that has been looking for a problem. And food safety, I think is, you know, a great fit. And for entrepreneurs, we have a lot of solution designers and entrepreneurs who watch the show. I encourage people to think about food safety, and the power of connecting every single thing to the cloud to the web to AI and what we can do. Frank, I don't know if you have any thoughts on that before we pitch in?

  
  

  Frank Yiannas 03:28

  Well, yeah, but the next didn't you know, I mean, to me, this isn't too foreign. Now. Why would you have somebody that just spent the last four and a half years and federal surfers working to try to advance the safety of food for the public, not only here in the United States, but across the globe. And the role of technology is critical. You know, when I was in federal service, I thought, the way we're going to make progress is with change. Simply put, if we don't change the way we're doing things, we won't make progress, we won't make progress on being able to feed 9 billion people, we won't make progress on reducing food waste, we won't reduce the burden of foodborne illness and keep people safe and improve the quality of lives. And I've often thought that it has to involve technology. Now, I've always said, Steve, it's got to be people lead smart men and women creative designing, how do we do things better, it has to be science based and rules based. And that's what I did at FDA with FISMA. And we're gonna talk a little bit about section 204, the food traceability rule in particular, but increasingly, it's going to be technology enabled. And so I think you're right on. But I've always said it's never really for me as a public health guy about technology per se. It's about the public health problem that we're trying to solve. And hopefully I'll share with you that there's some big challenges ahead that we have to solve now. If there's the right technology to address them, we should leverage them and that's why I'm a big fan of the work that Willie is doing and IoT in general. Our ability to create a smarter food system and even change the compliance paradigm from the way we've done it, let's say using the 20th century paradigm. So I think you're right on,

  
  

  Steve Statler 05:07

  I believe that what you did in setting the Food Safety Modernization Act, Section 204 rule, the new rule into motion is actually going to be a catalyst not just for Internet ambient Internet of Things technology, the subject of this podcast and the purpose for the company that pays me for my day job. But I think it has the potential to really revolutionize food supply chains, not just from the point of view of food safety, but to do a better job with omni channel to have a better experience to reduce waste to make it a more enjoyable experience to to understand more about where our food comes from. But you know, that's all a big left. And so I think it takes a mandatory piece of legislation that kind of causes people to raise their game. So how are we going to cover this, there's a lot to talk about, I thought we should start off with you. Just doing a recap on what is FISMA. And section 204. We had a another podcast about a year ago with Ed Tracy from the International fresh produce Association. But I think you're going to have a slightly different take on it, obviously, as the architects of that, that rule, then I'd like to talk with you about ambient IoT, which is a term that a lot of people are not familiar with, but they're going to become increasingly familiar with it as it becomes part of 5g, and the Wi Fi standard is already built on top of Bluetooth. But let's talk about that. And then I'd like to finish off with kind of a chronological, how did we get here? Where are we today in the application of the rule? And let's be, you know, candid, and yeah, I know you will be you always are. And then I'm, I think we'll end up with a which something which I think will really be interesting for people, which is your prediction of how it's going to pan out, you have now stepped back from crazy, the role. And I think you're pretty clear eyed, you're working with a number of, of your clients in your consulting practice. And I think you are probably the best person in the world to give us perspective on where it's going. So let's do that. But the other thing I need to do, just before we kick off is to just, you know, say a couple of words on the fact that you've joined Willie, Willie autism as a strategic advisor, you're offering your considerable advice and coaching us on what we need to do. And I want to thank you for that. And I think it's a great opportunity for us. But I really think it's a great opportunity for the whole ecosystem to embrace the new technology that can not just help them with compliance, but you know, all those other things that we touched on. So thank you for doing that.

  
  

  Frank Yiannas 08:05

  I pleasure. No, it's it's a it's an honor. And it was an easy Yes, Steve, I've been working on this idea of greater food, traceability, and more importantly, food transparency on the food system my entire career. And we'll talk a little bit about my history and leading some pretty big initiatives in the private sector, then going to FDA and as you said, being the architect of FDA new food traceability rule being really a strong force behind getting it done. We'll talk a little bit about why that was done. But since I've left federal service, you know, I have everybody that's working on food traceability contacting me, I can say humility. And you know, I haven't said yes, to anyone because I'm watching the landscape. But Ambien IoT is going to play such a critical role. I think it's a good bet. That this is one of the solutions, that has the potential to be a game changer to not only help us track and trace foods, but more importantly, we'll emphasize this a couple times today is go beyond tracking and tracing to Track Trace and monitor. And so that's a really important concept. And so, yeah, real honor and glad to be part of the affiliate team.

  
  

  Steve Statler 09:14

  Just let's get into that Track Trace versus Melissa, can you explain the difference? Here? Well,

  
  

  Frank Yiannas 09:19

  you know, tracking and tracing or traceability, generally, people presume you just need to be a bit a trace of food through its origin. We live in a very complicated society with a very large, impressive and powerful food system. But the food system is very decentralized and distributed. You know, we often talk about food chain, I wrestle with that, because everybody always talks about a food chain. I see it in written form, but it's really a food system, an interconnected and distributed food system. And increasingly, what we need to do is create greater visibility because there's so much anonymity in the food system. We really don't know what products were produced where how they were produced. Use, big manufacturers might not even know the ingredients that are in their product really in terms of where they came from, they can declare them. And, you know, the rule that we're going to talk about is presumably a food traceability rule. It's about being able to connect the dots and know where the food originated from how it traveled, whether it was from a farm to a processing facility to a distribution center, eventually to retail stores or food service locations, maybe ultimately to hold. That's traceability tracking and tracing. And while that's good, it's foundational, I think, to what Ambien IoT can do. It means not only can we track and trace the food, but we can know more about the food by leveraging things like IOT pixels. And so using sensor technology and ambient IoT, we can now know not only where the food came from, but important attributes about how it was maintained, how it was distributed, even how it was produced. And that's where I think the real power in this foundational food traceability rule is going beyond just knowing where it came from, but the how it was produced.

  
  

  Steve Statler 11:07

  That's really helpful. So we've talked about FISMA, or the Food Safety Modernization Act. And we've also talked about section 204. We'll get into, you know, some of the key buzzwords the concepts that people really need to know in order to get their head around it. But let's start off with what is the relationship between the Food Safety Modernization Act, which presumably is legislation and this rule, this new rule?

  
  

  Frank Yiannas 11:35

  Yeah, yeah. So for your audience, that hasn't been following Food Safety Modernization for the past decade and a half, you know, 2011 After a series of food safety scares here in the United States. We had the melamine incident in pet food where pets were die here in the United States due to melamine and pet food caused these illnesses and deaths. We had a spinach scare in 2006 2009, we had the peanut Corporation of America's large outbreak, I picked 700 Plus cases Salmonellosis. So there were some big food safety scares in the United States at that time. And Congress came together in a bipartisan fashion, and said we need to modernize our food safety laws. And they passed something called the Food Safety Modernization Act that was signed in January of 2011 by President Obama. And it was the most sweeping reform to our nation's food laws and over 100 years. It's pretty broad. Steve, it had a bunch of rules in there that FDA had to write an industry had to comply with, such as preventative controls, making sure that all manufacturers were taking their due diligence, identifying the hazards, and implementing controls to manage them. There was one rule called the Produce Safety Rule, a lot of the illnesses that occur in the US are produce related. If you look at what we call foodborne attribution studies, what we want Americans to eat more produce, unfortunately, when the outbreaks do occur, oftentimes their produce related not always, we had the intentional adulteration rule, you know, living in a new day after 911, not only trying to protect foods, from naturally occurring contaminants, but from potential bad actors that want to do harm. So there was a suite of seven foundational rules, but there was always one rule that was part of FISMA called Section 204. And it was called additional record keeping for certain foods, people often refer to them as high risk foods. But the rule is written with such certain foods and additional record keeping and always met traceability. And so Congress had given FDA a mandate that they had to write a food traceability rule, which we referred to as section 204. And so when I joined federal service, and maybe a little bit later, we'll get into how did we get here? How did how do we get to the point that FISMA was passed in 2011. And we didn't get the food traceability rule until 2022. I'd like to tell you that story. But that's what it is. It's about food traceability. And that's how section 204 came about. Congress gave, you know, FDA and food producers across the land of FDA regulated foods, which is about 80% of the food system, a mandate to say we have to do better at tracking and tracing certain foods. And the reason was, up until that time, we were operating under the old paradigm of the bipartisan Fairness Act. That said one step up, one step back traceability. But it didn't tell you how you had to do that. It was only one step up one step back. And so it always left me a little bit unfulfilled. One step up one step back. What does that mean? What are the data attributes that you have to capture and so I'm grateful that Congress wanted FDA to write this rule.

  
  

  Steve Statler 14:54

  Very good. So the rule gets a lot more specific So let's kind of dissect that so that everyone feels comfortable that they know what we're talking about for the rest of the the discussion. So what are the foods that are covered? Let's start there.

  
  

  Frank Yiannas 15:13

  Yeah, well, Steve, let me just back up if I can real quickly and I'll be so sick. I really like to say why, you know why, okay, the rule in the Y always informs what we do, and it's really important. I told you, there was some big scares that gave us FISMA. But why food traceability? Oh, and I like to say, you know, in my career, just about every food safety crisis that I've worked on, lack of traceability has been an Achilles heel, and our ability to do address it and I actually say today's food system is pretty impressive. Get me Bay, better yet, Steve can and it needs to be. But when you think about being able to go into a grocery store, even after the pandemic, and fined 50 60,000 Food skews different foods available for a fraction of your hard earned dollar. Now, granted, we're seeing some inflationary pressure and we should be concerned about that. It's pretty impressive. But the food system in my view, have to work 30 years on this and a large scale has an Achilles heel. And the Achilles heel was a lack of traceability and transparency. Just too much opaqueness. In the examples that I use, as in 2006, a large spinach outbreak in the United States, FDA and CDC saying consumers we know people are becoming sick with the harmful organism called Ecoli 15787. We know through interviews, epidemiological surveys that most of the people becoming ill have consumed bagged spinach. We just don't know where the back Spanish came from. And they advise all consumers nationwide tonight back spinach. I don't have you remember, if you were in the States at that time in 2006, bagged spinach everywhere being taken off the menu, restaurants, grocery store, that industry was devastated. The fitness industry will tell you it took them about seven years to recover from those losses. But when FDA did the trace back, because we didn't have good traceability requirements, it took them two weeks to trace that spinach back to source and whatnot. It was all said and done. It was one spinach producer one day is production. One lot number. That's what a lack of food traceability will do. It could potentially devastate entire industry, you're all guilty until proven innocent. And if you don't pull it rapidly enough, it could cause a lot of illnesses, right. And so that's why public health agencies react like that. If you fast forward to the year 2018. In November, when I joined FDA, literally as I was joining, we were having a romaine, outbreak. Same story. 2006. Fast forward to 2018. Same incident, not much progress, you know, in all those years over a decade, or 2009 When I was at Walmart PCA, it was a company that produced about two to 3% of the peanut paste in our country. Recalls happened, Steve, I can remember sitting at Walmart home office and getting contacted by big brands that you would recognize and say we got to do a recall, because we found out our peanut butter crackers or whatever they made contain PCAs and ingredient and guess what, Steve? These recalls were coming in three months after the original PCA recall was identified. Lack of traceability unacceptable and 21st century that companies would take three months to tell you that they had PCA peanut paste in their product. And so this lack of traceability is serious. I mean, it can cause people to be ill because you can't pull contaminated product faster. And if you do these over abundant and overcautious food advisories, you know, it destroys the livelihoods of food producers that are unaffected. So it's really, really important. So we went on to write the rule and I want to tell you when you hear the food traceability rule section 204. I try to break it down so you understand what it what it says. Congress said, We want you to require this additional record keeping for certain foods versus certain foods, that meant they didn't say all foods. I think one day we're going to see all foods have these type of capabilities, but for our was certain foods. And for FDA, what we did is we went through and identified the types of foods that are frequently in placate implicated in foodborne illnesses. We created a risk ranking model based on criteria that Congress gave us and it's available on FTAs website. But it was based on the frequency of illnesses, how much they cost to society, with their producers have controls that can eliminate the hazard. And we created a list of foods and it's pretty broad. I haven't calculated specifically how many SKUs or what percentage of the grocery store total entail but it's going to be a very large section. But they're obviously all the fresh fruits and vegetables that are cut, obviously because once they're cut they can support microbial growth, fresh leafy greens, fish products are on there, soft cheeses, some of the nut butters like peanut butter or almond butter that have been implicated in illnesses, fresher herbs, you can go out to the FDA website and you can find the list of what we call the food traceability list or food traceability food. So there's going to be a lion's share of food products and your grocery store. Now, some retailers are telling me it's too hard to discriminate which foods per will cry or traceability and which won't. So I think they're going to default to requiring this for more foods than not, but there's a list of types of foods. So if you're listening and you're in the food business, or you're interested in providing technology solutions for food traceability, get familiar with the foods that are on the list. This to other three other important concepts that the rural states d bar, we defined what we called key data elements, and critical tracking events, KT E's and CTS. And you heard me say I was a little bit unfulfilled with traceability legislation in some parts of the world. And even here in the US with the bipartisan preparedness act that said one step up and one step back traceability. Well, you're a data and tech guy, right? That's generic. I mean, what do you do with that? And so we at FDA tried to write the rule with what I call a 21st century lens that said, really, to be able to do this unit, you need standards, data standards. And so based on some pilots that we had done earlier, we said we need to really start rallying this large distributed food system around this concept of critical tracking events and key data elements. Critical tracking events, is where should these records be captured and kept, right? So at production, if you ship a food, you ought to keep a record of what you shipped. If you're receiving the food if the food gets transformed in some type of way, those are critical tracking events and the key data. And that's what type of data attributes that you need to keep location, obviously, quantity of food type of food. So it's important to get familiar with these key data elements and critical tracking events. And at FDA, we try to give examples of what they are for the different nodes in the food continuum, if you will. We also then went further to state that we want foods to have food traceability lead lock code. And we want that lock code to be maintained throughout the food continuum. Because one of the things we learned, Steve, is that people really enamored with lot codes of batch numbers, and they were at different points in the food system, even if the food wasn't changed, or transform. Somebody wanted to give it its own lock code, or it's a lot numbers. So you could have in the lifecycle of a food product, five different lot numbers that were totally unnecessary. And so we've come up with this concept of the food traceability lock code to try to keep consistency there. And where

  
  

  Steve Statler 23:01

  does that lock code start? How early in the life of the lettuce, we early

  
  

  Frank Yiannas 23:07

  so if you're going to do a bag of lettuce, that's where you're going to give it a food traceability lock code unless that product gets changed. And in some instances, you'll have a food product on the food traceability list that will travel through the food continuum, and then make its way into another food product. So when it's makes its way in another food product, that product unless there was a kill step. For that food that's on the food. Traceability will require continued food traceability, and there'd be a new lot futuristic, a lot assigned at that point. But the the situations are examples where there are lot codes assigned where they're not totally unnecessary because the food hasn't been changed. It's mainly a change in ownership. There's no need to reassign a lock code in those instances.

  
  

  Steve Statler 23:54

  So in the industry, we like to talk about Farm to Fork, has this really span farm to fork? Can I go from a field to something that's in someone's home or does it stop at the store?

  
  

  Frank Yiannas 24:06

  It's it's a it's a great question, because, you know, the course of my career I've seen in these food safety scares, there's always been a lot of finger pointing as we were working to try to improve food traceability, you know, the growers would like the point further downstream and say it's the retailers that don't do food traceability the retailers would, because I was a retailer, we'd always point the finger and say those farmers need to do a better job. The way we wrote the rule is we are requiring food traceability through point of service, whether that's a retail store, a restaurant or food service establishment. That's a big deal, Steve, because the reality is I'm not into pointing fingers but I have seen in federal service I oversaw FTAs foodborne outbreak response team. The real challenge has always been what does the consumer buy? We know there's ill consumers, but it's hard to make a connection with Which were the food they purchased because at the retail level, they generally didn't have traceability to what went in their store. They have traceability of what went into the DC. But then you've always lost traceability by and large, almost always, with what goes to a restaurant, what goes to a store. And so the rule intentionally we wrote it, you need traceability through point of sale. Now to the fork, I don't know, it's the consumers home. But increasingly, I think that's likely, as we're moving to this digital age, right, where we now know what people are buying, whether it's because they're doing orders online. So we know they purchased, let's say, a bag, a salad, because they placed the order online, and now they pick it up at the store, or a lot of retailers have loyalty cards that can identify what they purchased. And so right now we're going to at least get to the store level, which is a good start. But I think increasingly, we're going to be able to make those connections to what consumers purchases. And I saw that in my career Walmart, Steve, you know, when there were recalls related to fresh leafy greens, when I first started at Walmart, there was no way we could notify a customer. Because Walmart didn't have loyalty cards, we could do it at Sam's Club, because we had membership cards, so we knew what they purchased. But by the time I left, so many people were Portuguese purchasing online and picking up at the store, by purchasing online, you know, we could contact millions of customers were three years earlier, I couldn't contact a single one, that trust formation occurred at a period of just two or three years.

  
  

  Steve Statler 26:30

  So I think this is who gets to see the data is my next question. So this is potentially, I mean, certainly very interesting data for many, many reasons, consumers think increasingly want to know, where did my food come from? And, you know, obviously, first, is it safe? But then, you know, what's this produced? Under what conditions were the workers working? Is it a farm that is using a lot of inputs? Or is it a regenerative farm where it's actually pulling the carbon out of the atmosphere? It seems like this, again, is gonna the first thread giving people that visibility, but going back to the food safety, because because because that's what the rule is focused on. Is this something that the FDA gets the information? How do they get the information? And And what about consumers?

  
  

  Frank Yiannas 27:27

  Yes, so the way the rule is written is if there's an investigation and FDA asked you, you're going to have to submit traceability records to them in electronic form, very rapidly. So FDA will have access to help them conduct outbreak investigations and determine what was the product that's causing illnesses tried to remove it from the market as soon as possible to protect other people from becoming sick. Not only that, going a little bit further, Steve, and then they could do a better root cause investigation of why it happened in the first place and try to prevent reoccurrence is, which is an important thing, testament to food traceability. It's not only pulling product off the market, but it's learning so that we can prevent these things from happening again. There's nothing in the regulation or the rule that requires that information to be shared with the public. But I can tell you the FDA is policy is when they're involved in an outbreak investigation. And they determined that a food product might cause harm there, their desire to be transparent with the public is they they mentioned that and we'll go out with a consumer advisory and tell consumers to avoid certain foods or certain large numbers. If we have that type of specificity. What's going to happen as you know, we get started getting better compliance. But this rule itself is that those advisories will become more focused, more precise, as opposed to avoid all romaine lettuce, we could say avoid romaine lettuce from this farm, which is used by dates on it. And then eventually as we start doing more of these digital connections, I think we'll see a day and age Steve, where consumers might hear something on the news might not really catch that it was particular brand or lot number, they'll be able to go into their cupboard at home and scan a product and know whether it's been implicated in a recall or outbreak. And to your point further on, although it's not the rule itself, but you touched on this, and I think it's worth mentioning. I do think consumers are changing. The consumer is the key. And the 21st century. It's the data age, and increasingly, they're tipping the balance of power. You know, when I was growing up in the profession, we assumed regulators had this great authority. But now, you almost have to have a social licence to do anything that you want to do with food if you're a farmer, you know, do I have a social licence to use this type of practice? Do I have a social licence to use gene edited crops do I use that type of social licence to use this type of fertilizer? But today that way that information is provided to consumers is generally with labels. And as we start creating this digital footprint of these digital connections, we'll be able to provide information to consumers. So it's not just something that's on a label, but they can verify if in fact, the claim is really actual. Here's a perfect example. For your listeners. I don't know how many purchase organic foods, I'm not asking you if you do or doubt, Steve. But do you know there's more organic food sold in the world than is produced in the world?

  
  

  Steve Statler 30:29

  Hidden, it's disturbing.

  
  

  Frank Yiannas 30:31

  It's disturbing. But you know, people could put a label of organic on there. But in the future, I think we'll be able to do these verification procedures a little bit better.

  
  

  Steve Statler 30:41

  Now I was in, I do tend to buy food. I feel like I've just pigeon holed myself. But there's an amazing, actually, recently, I've started going to Walmart. But for groceries for this kind of organic food, then there's a local supermarket, there's like, I think five, five of them in San Diego. They're called gem bows. And they actually say, these sweet potatoes came from a farm 37 miles from this store, and they give you the name of the farm, okay, and that level of connection is worth a lot. And I can tell you, it's not the place you go for, for for budget, sweet brainers. But when you get that, that's Merchandising, and it's a story and it's, it makes you feel like you're getting real value for money, you're supporting local farms, which kind of feels good, probably less fuel required to get it from the farm to to where you are. So I think telling the story of the food. And that's why I'm excited about Ambien IoT enables that story to the the threads of the story to be gathered in a very automated way without having to hire a ton of people or write like millions of dollars of infrastructure. It's like commodity radios, it's the same radios that you are using in your phone and your Wi Fi access points. And so I think this ability to start to add a level of automation, without the expensive handheld scanners and so forth is key, but we're getting ahead of ourselves. So let's go back to the rule. One of the you know, rules have deadlines. So perhaps you can tell us about the status of the rule. And you know, the the deadlines that are associated with it.

  
  

  Frank Yiannas 32:35

  Yes. So the rule was finalized you the way rulemaking works in the United States is the agency FDA will issue a proposed rule. We did that during my tenure and 2020. We held public meetings to hear you know how we took a crack at the proposed rule, we considered that feedback. And then we issued a final rule in 20 to 2022 in November 2022, with a compliance date of January 2026. So Steve, you're looking at it, it's July 2023. If there's anybody thinking about the rule and thinking, well, we have some time, we really don't. January 2026 is right around the corner or shoot, it'll be here at the blink of an eye. It's so if you're working in the food sector, or you're working supporting the food sector, the time is now you have to start paying attention to these rules and start making efforts to understand the rule understand if there's any gaps. What are the data standards that you need to implement if you're already leveraging global what I call consensus standards, such as the GS one standards, you're well on the way you're on the 90 yard line already, and she has one is published some great documents on how to comply with Section 204. But you need to get started right now. So that you can be compliant. So January 2026, because it'll be here before you know it.

  
  

  Steve Statler 33:59

  And I'm chomping at the bit to get on some of the other topics that I want to make sure that people understand this one up one down thing because I think you talked about the fact that one up one down was not enough and how does to a fool go beyond that one up one down?

  
  

  Frank Yiannas 34:20

  Yeah. Well, Steve, I wish some of your listeners could have been in the sessions that I participated in where you have a national crisis, there's illnesses, deaths occurring because of a contaminated food product. And you're trying to trace that product back to source based on people are saying they're sick and we find out most of the people have been sick. There's a statistical association with certain food product when all that you had was the Biatches preparedness act that said you must keep records one step up one step down and doesn't specify how you do that. You know, we tend it would receive is a lot of paper records, believe it or not, in this food system, a lot of the records are still being kept on paper, right? The Read doesn't require digital data. But I think that's the way people are going to comply. But when there's no specificity to the data attributes, you get packing slips and invoices, none of them are standardized. And you have to try to connect the dots with this complicated supply chain that might be five layers deep. And so it takes a long time to try to piece that together. So what the rule did is we don't require that any one entity have full provenance, from farm to table. But we require that if you're a node in that food system or food continuum, you do your part. And by standardizing these key data elements, even if you keep track of it on paper, but increasingly we're seeing people are leveraging digital systems, it connects the dots, so to speak more quickly, and you can trace it back to source. And so by every node doing their part, and everybody speaking, what I call by standardizing or harmonizing around key data elements, critical tracking events, we're requiring everybody I like to use the analogy to speak the same language of food traceability. And once we're speaking the same language, you can make those connections mass much faster. And what I'm seeing, as Steve is that people are saying, hey, the only way to really comply with this and we're doing this in other sectors, right, you can track your luggage, you can track a package that you order on Amazon to your door. Using digital technologies, we're seeing that we're going from a time period of days or weeks to being able to track a food to origin and seconds. In fact, some of your listeners will know the mango story because when I was working at Walmart, we started digitizing these food records. And I did a proof of concept in those days, this was back in 2017, or 16, I took a package of sliced mangoes came into Walmart staff meeting, I put the package in the center of the conference table in a conference room and I told my team, tell me where those mangoes came from sliced mangoes. Steve, it took them six days, 18 hours and 26 minutes. Because of this one step up one step back traceability. Once you start connecting these dots the way I'm talking about now, if we did that, we could scan a package of mangoes and trace them back to source in 2.2 seconds raising. So what I call food traceability at the speed of thought. And so that's the future that we're going to see because of this rule.

  
  

  Steve Statler 37:21

  And rule it runs the route to a four essentially you have 24 hours within following a request to get a spreadsheet, which electronics be in any format. Yeah, which has that one up one down and this source ID right where the the origin was of the of the product. I imagine that there's a lot of CEOs of food companies, whether it's fast food restaurants or or supermarkets that probably say we take food safety seriously. I remember writing a check for a whole bunch of systems. We're probably compliant. what's your what's your sense of the state of readiness of industry? Today?

  
  

  Frank Yiannas 38:19

  Yeah, I think there's work to do. If we thought there was large compliance without the rule, we wouldn't have needed the role wouldn't have passed at. So I would say it fears a CEO out there thinking, hey, I'm already in compliance. You need to you need to do challenge test, if you will, for lack of a better term. The industry does a lot of recall, readiness type exercises, if they were going to execute a recall executed and test whether they could do it or not. I'm advising organizations say, do a gap analysis against traceability, you get a product that you have or you produce and see if you could trace it back to source in hours or minutes. And then you'll see whether you're in compliance or not. So my sense is there's work to do I think they're capturing data, they might not be capturing it the way that the FDA is asking for it. I was at FDA. Steve, I'll tell you when we wrote the rule, I was very aware of that there are some industry best practices in the world is already moving this way for commerce purposes, right? We want to track and trace foods for the ability to do commerce in an effective and efficient means. And I didn't want FDA to write a rule that was absent or devoid of what's already happening in the marketplace. And so as we wrote the rule, and we defined the key data elements in the critical tracking events, we did an exercise of bumping it or comparing it to these consensus standards, such as GS one thing that I mentioned are PTI. And so that's why I say if you're already leveraging some of these global consensus standards for commerce reasons, you're probably going to be in pretty good shape. But if you're a food producer that does not already leveraging some of these consensus standards, you probably got quite a bit of work to do to be in compliance. So don't don't assume that you're in compliance would be my take home message.

  
  

  Steve Statler 40:14

  So it's a matter of having using the right data standards like GS one having G tins, and using their standards for location and making sure that your suppliers are talking the same language and getting the connections between them. So that's a ton of work. And then there's the whole question of, okay, I've got this unique ID, this traceability lock code. But it's not just a matter of getting one and done, I get it from in some EDI, electronic document from a supplier. They have to trace it, as I understand it, and feel free to correct me if I'm wrong, they have to track it, when the light comes into the DC. And maybe that light gets transformed, or maybe it it then potentially gets mixed with other lots. You if you've got a big DC probably it's not just one a lot of oranges that have lettuce that is, or spinach that's coming in. So you need the where with all to keep track of the lock code among similar things. And then you found out and go to different supermarkets say, and you can't, as I understand that it's not just a matter of Well, we think it went here, it's like, you actually need to track it to scan it. And then you know, I think the whole supermarket industry was built with a different paradigm before omni channel before COVID Got to spying online and picking up in store and home deliveries and they'd found that what you thought you got shipped isn't necessarily or you got shit. You know, really, as a company, our focus is like we're like becoming laser focused on Miss shipments. Because, you know, with these Ambien IoT pixels, these things looks a bit like it's a postage stamp thing, it's talks Bluetooth, to very low cost devices, you can immediately detect when there's a miss shipment without having to hire a ton of staff, and, and so forth. And so not using handheld readers. And so there's much better compliance, but not a bunch of additional jobs, no additional jobs being put in place. But you know, my understanding at least is that it's about automating the receiving as well as the dispatching of the goods to ensure that you've got accuracy. Is that, is that fair? Obviously, I'm biased because I work for a vendor of technology.

  
  

  Frank Yiannas 42:54

  Well, I think you have a really good understanding of the rule itself. And I think that last mile, if you will, going from DCS to retail stores and to Food Services is going to be a really challenged point in the rule itself. Because this type of record keeping hasn't taken place to the state. And I told you it's largely the gap when there's illnesses, we will know they stop they shopped at a particular retailer will know they beaten that a particular chain, but not knowing with certainty what was shipped to those stores has been a problem. For the past four and a half years I was in federal service. And what the retailers and food servers so distributors will do they get they'll give you estimates, they know what they've received into the DCS, they know their rate of turns, they won't have a record of what they shipped to those stores. So they'll tell you, we think we could have shipped these five lots during that timeframe. And so there's there's not a lot of specificity. We know for any metric, you know, if you've taken statistics, these concepts of you've got to have precision and accuracy. And so what we want is precision and accuracy with what has been shipped. And so that's why I've been pleased to start working as a strategic advisor with William because of these that stamp that stamp looking device that you just held up if you can actually track with precision and accuracy, what goes to a store. And I think the type of technology with IoT pixels. The reason I think it's such a game changer is you can then track that using what I call a low labor model. Because that at the food service companies in the retail companies want to be scanning a lot of cases, right? So that you can capture that data without batteries and low labor model fashion. That's the game changer. And not only that, Steve, we haven't even touched on that. But not only will you be tracking the product, remember I said it's not only about track and trace, but it's about monitoring. Well, you could start overlaying some additional functionality such as temperature, for example, and you can move First In First Out to first expired first out and reduce food waste. And while I was the deputy commissioner for food policy, food safety and response, I'm a firm believer, because of my 30 years in the private sector, that the real benefit here, while there's a food safety benefit I did, I led the cost benefit analysis to the rule, your audience needs to know, if you're going to do a rule in United States, you just can't come up with this rule and say we're going to implement it and cause the regulated industries to comply with it, you got to do a cost benefit analysis and stakeholders have to react and Congress has to react. And there's a cost benefit analysis done for the food traceability rule, and there's a return on investment just on preventing illnesses. But the real benefit is going to be all of the other benefits that we're going to derive, you'll be able to do food safety in a more compliant and more efficient manager manner and reduce costs. You're gonna reduce food waste, which is a significant cost to society, a third of all food that gets produced gets wasted. Food Fraud, you know, economically motivated adulteration, you know, we talked about there's more organic food sold in the world that has produced in the world, by creating this level of transparency, you'll remove that type of unscrupulous behavior. And so their sustainability, I mean, we can go on and on, really, the benefits in time will be measured. And we'll be look, we'll look back, Steve 10 years from now and say, Oh, wow, food traceability was I use the analogy of pouring the concrete for it, the Interstate Highway System. And all the other benefits that you'll derive from this using IoT, Ambien IoT type of technology, and other technologies is going to be a real danger, you're quite frankly, needed for food. Like I said, at the beginning, there's not too many topics that are more important to food to society.

  
  

  Steve Statler 46:55

  I think it's so I realized times got away from us. And we do have, fortunately, there's gonna be a we have a webinar coming up with food safety magazine, where we get to kind of present this in a more structured way, cover some slightly different aspects of the of the topic. But I do want to talk to you about, you know how this is going to play out. And I'd like to offer my own prediction, which is, I think it's actually going to be the larger, more technologically savvy retailers, and it's not always the large ones that are but you know, there's some very notable ones, we're all very familiar with an incredible technical capacity in driving for adherence, and they know that they, they can't just scrape by with a C minus the they, they have to do this properly. I think when they do that, they have the opportunity to go from being perceived as the value player to also being the quality player, if you suddenly get this ability to see the cold chain of your of your perishable products, if you can go to repurpose, first with the data that you have, and you can start to open up that data chain to consumers and they can see the story of their food, then it may not be Oh, I go to this merchant because the you know, the prices are low and this merchant because of the quality of the product. I think those actually, technology could bring those two things together. But I'm interested in your sense of how this is going to play out. And specifically, inevitably, when you've got the you've got the January the 20th 2026. Deadline, the rules already finalized, the starting guns already been fired. Do you think the industry is going to be ready on time? I guess that's probably the biggest question

  
  

  Frank Yiannas 49:08

  here. Well, I you know, I get that question a lot. And people will say, Well, should we should we be serious about January 2026? And the answer is yes, you should be very serious about it. Because the final rule and a compliance date. If you've looked at what happened with the drug supply chain and the drugs supply chain security act, it took them a long time to get that one done. It's been in the making for about a decade. I was involved. Steve, I was there within FDA talking with all of the branches of government that were involved with this compliance dates. And we were all very committed and intentional to the January 26 date. You know, you you would be naive if you're listening to this and not think that there were conversations say do we make it more aggressive yet? There were conversations about that and there were conversations about D tube Push it out. But I would say on balance, the total of those conversations was nothing less than 2026. And maybe even some considerations of going faster, because I think we're at a very different place. So your audience should assume that the 2026 date is going to stick and they should try to stick it and get on the journey. I think, you know, we're at a different place this is that I, we have the tools available, we're talking about Ambien IoT, we're talking about either of these stamp light sensor devices that are available for a fraction of what they cost years ago. I think all the tools are there to comply. It's just getting started now and for large organizations, you know, moving the inertia to do it. i My sense is what's going to happen is, companies are going to figure out how to comply in a way that's beyond what I call mere regulatory compliance. Right now, people are just thinking, Okay, how do I comply with Section 204? I don't think it's gonna be long, I think there's gonna be a couple of use cases early on, and people are gonna say, Wow, the benefits of doing this far exceeded just complying with section 204. And now look at what I've been able to done, be able to do, I'll give you one example those slice mangoes that I told you about. When you can optimize the flow of those slice mangoes from small and medium growers in Central and South America, those mangoes that have to get to the US crust, the US Customs Border, they then go to a processing facility that us where they wash, PLM and spice and then they go to 6000 retail outlets across the nation. While it's not a high volume miscue, there was a lot of food waste or shrink in those stores because of that one, and you just optimize that supply chain just a little bit with the insights that we're talking about that you can capture here with this type of Ambien IoT technology, and temperatures, you just pull one day of distribution out of the continuum and give that day back to the consumer. You reduce shrink in retail stores, to the tune of 10s of millions of dollars, consumers get a fresher mango product and they're happier. Guess what else you could do, Steve, if you purchase lice mangoes, I like mangoes my mom was from Cuba. If you notice, they're usually a little bit hard. Why is that? I'd love to because they slice them when they're not perfectly right, because they're afraid of those products getting wasted. But when you have more confidence in your ability to master that supply chain, you can even offer a better quality product to the consumer.

  
  

  Steve Statler 52:40

  And I think that that's an opportunity to change market share, I really do because I will drive a long way to get a good mango, or tomatoes that that tastes good. And so I think if this wave of automation that comes in, it's driven by compliance, I think it will be a competitive weapon that's used, and it will enable people to gain share. Because, you know, if word gets round, you go for the best tasting food, then then then people will move who they shop with.

  
  

  Frank Yiannas 53:20

  Steve, one other comment, you know, we could go on for hours here. But to me it goes even beyond this. It because we're talking so much about tracking and tracing, we're talking about monitoring, but it really all then becomes data, right? capturing data at every node of the food system, about how food is being produced, how it's being handled, how it's being maintained. And you know, I I've been quoted as saying better food safety begins and ends with data, better food safety, or better food quality begins and ends with better data, better food sustainability begins and ends with data, our ability to feed 9.57 10 billion people begins with better data, our ability to deal with climate change begins with better data. And so it really is about to creating a smarter, more resilient food system. And so I think this goes all the benefits that we talked about are there, Steve, but I think it's an it's almost an imperative for the future of food and society at large.

  
  

  Steve Statler 54:17

  So Frank, we're at the part of the show, it's actually my favorite part of the show where we get to talk more about the guest and we've been very fortunate, especially fortunate in your case, there have been some people that have really achieved some amazing things. And so I I'm always fascinated about how they got to where they got to so you know, thinking back way, way early and into your childhood. Would would anyone have predicted that you ended up doing what you were doing? Were you like the class president or was your childhood like?

  
  

  Frank Yiannas 54:54

  Yeah, I don't know the, you know, the people that I hung out with and went to school All together with would have predicted that I would end up as deputy commissioner at the Food and Drug Administration. But you know, I think some of my foundation in terms of early youth was critical. I'm a strong believer, as you know, Steve on the importance of behavioral psychology. And I do think our foundational you ears are critical in shaping who you become. So I was born in Manhattan, and then moved outside of the city. So I'm a New Yorker by birth and still identify as a New Yorker, and I was a second born. And so second borns tend to be a little bit competitive. I had an older brother, I was very interested in sports. So you know, sports help you to understand, and especially team sports, baseball, and football, you know, they help you become team players. And so I think, you know, a lot of those principles shaped who I am, my parents were immigrants. So I'm a first generation American, you know, I've learned a lot about work ethic that you could do anything you want to in this great country. And so I think those early foundational years shaped who I became, and I look back now, and you might say, it wasn't a perfect trajectory to get into becoming Deputy Commissioner, large global scale in the US. But those principles, I think, certainly manifest themselves and were useful. And the work that I've done

  
  

  Steve Statler 56:23

  is interesting about how many of America's great achievers you know, I have that strong origin story from from somewhere else. And you can probably tell from my accent, I didn't grow up in America. So I it's for me, it feels like an incredible privilege to come from. When I grew up. In the 70s. In England, I was always interested in technology ever since I saw 2001 A Space Odyssey and how did the tried to kill all the astronauts? I wanted to be part of that. And there was, you know, England as an amazing history in technology. But there's no question that where it's happening is in the United States. So to get to come here and to be part of it is so exciting. And I think it's a motivational for so where did your parents come from?

  
  

  Frank Yiannas 57:19

  So my father was born in Greece on a small island on the west coast of Greece, the largest of three Ionian Islands called gefallen. Yeah. He lived through World War Two there saw, you know, occupation of the island that he was born on, and, you know, tried to escape that in a better life and came to the US and as you would imagine, came to New York, New York, at an early age at at the age of 18, and my mother is of Cuban descent. She was born in Havana, Cuba, and she escaped communism. And so, you know, it's interesting that you say that because we are a product of your background and how we were raised. But, you know, they came here to create a better life, and they just instilled in me and my brother, the idea that, you know, this is a wonderful land of opportunity. You can do anything that you want, son, you have to go to school, you have to study hard, you have to work hard, but the opportunities are plenty and so I still believe that to this day, but they certainly shaped who I am, my brother became

  
  

  Steve Statler 58:17

  before the FDA, you have this amazing resume of Disney and Walmart. How did you end up getting a job at Disney? That's, like, one of the I don't know where their brand equity is, but it's got to be like in the top five pretty good.

  
  

  Frank Yiannas 58:32

  Yeah. It really is a wonderful company here. You know, they've been in the news lately. All I can tell you is Disney is a fabulous organization. Really their attention to detail quality Culture Show. guest satisfaction is really just off the charts. But what happened to me Steve, I went to college in Central Florida University of Central Florida. I got my undergraduate degree in microbiology. I went on then to get a graduate degree in Public Health at the University of South Florida. But earlier in my career, I I did three steps. You know, when I first came out of college, I worked first it was a pharmaceutical company doing fruits, not food safety, but quality assurance in the pharmaceutical industry. And it was really good because the pharmaceutical industry has very high standards, SOPs and validation studies. But I did that for a year and then that plant closed their facility in Central Florida. And I was offered to relocate but chose not too and so I went to my first food job. I worked as a Quality Assurance Manager at an egg processing facility. We made pasteurized eggs we took shell eggs, crack them obviously in an automated fashion and created pasteurized egg products, whole eggs, egg whites, egg yolks, got my first taste of food, did that for a year. So this is two years out of college and I said well, I don't think I want to do this for the rest of my life and then went to a cosmetic manufacturer in Melbourne. Florida went on the coast. But that would be interesting. And so I've done you know, a lot of different mediums here food, pharmaceutical and cosmetic. But I was working in this cosmetic manufacturer Melbourne, Florida one day I was in the cafeteria. And back then we had the payphones on the wall and the payphone rang. Another employee picked it up and said, Hey, there's a gentleman on this line looking for Frey Gowanus. It was a painful and I don't know how this happened, how this fella track this number down. But I picked up the phone and it was the college professor that I had worked for. It was really because of him Dr. Rudi was Lewinsky that I actually focused in microbiology. I got my degree in micro because of him. I consider him one of three life mentors. And somehow he chased me down and at a payphone in my employers cafeteria and he said, Hey, Disney is looking for food safety person to start up their first lab. They've been testing foods for a long time. But they want to do it in house and he made the connection. And I went and interviewed at Disney and lo and behold, ended up getting the job staying there for 20 years moving up in the ranks. I eventually started their lab, oversaw the lab as a group then became the manager overall food safety efforts and then went on to oversee just about everything safety at Disney. Before I left there, I was overseeing Occupational Safety and Health guest safety, I was involved with attraction, safety, food safety, and not only at the Walt Disney World complex in Central Florida, but theme parks and resorts century ships worldwide. And so it was a fabulous place. I like to say I got my business trading, I got my my business, MBA at the Disney theme parks and resorts. And then I got out into the real world after that. And I said, Oh, they don't all operate like Disney, you know. So Disney was fabulous. And I went on, as you know, to work at the world's largest retailer, which was also a wonderful experience Walmart, you know, one out of every $4 spent on food approximately, in the US is spent at a Walmart store. So big impact on the large scale of the food system. But I like to joke that I went from the happiest place on earth to the busiest place on Earth, Walmart. And that was a good run. But you had to solve problems differently at Walmart, you had to solve them at scale. So really simplify and try to automate, Disney could rely on culture. And then thereafter that Steve, I got called in 2018, after a decade as global vice president of food safety at Walmart. I got a call by Commissioner Scott Gottlieb who was a bit of a celebrity commissioner at the US Food and Drug Administration. And he said, Hey, I've just joined federal service and doubled looking for somebody to head up our food safety efforts. And I did the transition from the private to public sector. So I said, What, from the happiest place on earth to the busiest place on earth, to one of the most important regulatory agencies honors. So it's been a great run. But Steve, I think the bottom line is, you know, every opportunity has been wonderful. I like to say I probably learned more than I taught in each of those organizations. They were brilliant. But it's really been a great run. And what an honor to serve the American public during the last four and a half years as deputy commissioner for the US FDA.

  
  

  Steve Statler 1:03:19

  And you worked across multiple administrations, didn't you?

  
  

  Frank Yiannas 1:03:23

  Yeah, one of the things I wanted to do was to show that food safety is not a political issue. And it's not a partisan issue. So I worked under the last two administrations, two years, under a Republican administration in two years in a Democratic administration. And I say, Steve, you know, the pathogens in the food supply don't recognize political parties. So when it comes to food safety, neither should we Yeah. And I intentionally want to do that to send a lousy message that we can't approach this topic with a partisan mindset. Now, the good news is, you know, I've worked with politicians and both the Senate and the House. And, you know, I think they get that, you know, this is a pretty divided country, sometimes societies, not only in the US around the world are polarized. But if there's one area that's really important for society at large, and we shouldn't polarize, it is food and food safety. You know, there's not a lot of topics in my view that are more important than food. And this intersection between food and technology is critical as you think about the challenges that lie ahead, you know, feeding 9 billion people reducing food waste, making sure that it's safe, the effects of climate change.

  
  

  Steve Statler 1:04:37

  So one of the so many interesting threads that cross these three huge pillars in your career, but one of the things that just occurred to me and maybe it's obvious is that Disney kind of runs cities, doesn't it those cruise ships, so like a city the the, I think, technically and all handmade is a city To hear that they have governance and everything about a city. So was that to what extent was that helpful when you went to the FDA? And to what extent was it like jarring? Because obviously, as a private as a company, they can maybe control more than then in a democracy,