 Well, thank you, Brian. And good morning from the US, regardless of where you're at around the world. It's a real pleasure to be participating in this hyperledger event. As you heard from the introduction, I work at the FDA, but I spent most of my career in the private sector, and I've been with FDA for a couple of years now. What I was hoping to do today is talk about FDA's new era of smarter food safety and the role that new emerging technology, such as distributed ledger technology, will play in that. Right at the outset, you might be saying, well, why is there a public health food guy at a hyperledger event? Well, number one, I would say we have more in common than you think. If I were to ask the question, how many of you eat food, if we're in a live audience, all of you would raise your hand. And number two, I've long recognized the important role that distributed ledger technology and blockchain can play because of work that I did in the private sector. But let me begin with this premise. And I think you heard a lot of it already this morning. The world around us is changing pretty rapidly. We've heard this quote that never before has the rate of change been this fast, and never again will it be this slow again. Well, that's true for food, too. You think about the food system. It's been changing from the beginning of time. At the beginning of time, humans were hunting gathers. They then started domestic plants and animals. We had the industrial farming revolution in the early 1900s. And around the 1980s, when I was going to the grocery store with mom and dad, there were about 15,000 foods, different food products. How many do you think there were at the turn of the century? There were close to 50,000 different food items. And where are we going? We're really going to the place where the food system will be an endless shelf where consumers can go online or to their favorite grocery store, whether it's brick-and-mortar or omnichannel, and get anything that they want from anywhere around the world at any time. Granted, the pandemic has presented challenges, but we'll get through the pandemic. And I believe that supply chains will be stronger and more resilient than ever. The other thing that we realize is the food system is changing. The reality is, as we speak, we're seeing foods being reformulated. We see new foods being realized, whether it's cell culture or plant-based foods or gene-edited foods. And we're seeing a lot of change. I believe we're literally in the midst of a food revolution. And to succeed in these modern times, it's the FDA's opinion, and many in the food industry's opinion, that we need more modern approaches. It's time to leverage. And so at FDA, we've created a long 10-year view of how we want to modernize the work that we do over seeing food for the nation. And we're calling it a new era of smarter food safety, which will continue to be rules and law-based, but increasingly technology in age. Now, I'm going to give you two examples in the few minutes that we have together today of real work that the agency is doing using new and emerging technologies. One is distributed ledger technology or blockchain. I always like to emphasize, as a public help guy, for me, it's never about the technology. It's really about what is the public health or business challenge that we're trying to solve. And when it comes to distributed ledger technology, it's this. The reality is, even the biggest of companies don't really have a lot of visibility into how food they buy gets produced, transported, and ultimately ends up on their shelves. It's pretty difficult because we have a very large distributed and decentralized food system. In fact, oftentimes people talk about the food system as a food chain, and I try not to do that because it's not linear fashion at all. In fact, as I learned and studied about blockchain, I thought the way the food system is created, very decentralized and distributed, it models blockchain technology, and that's where I became interested in. We've all seen food scanners because we do have an inability to track and trace foods quickly. It results in, for example, consumer advisories where the FDA or CDC might say, don't eat any product until we find the source of the outbreak, and sometimes it can take weeks for us to do that. When I was in the private sector, I did a proof of concept to illustrate why I think the power of blockchain is so great. Some of you may have heard it, I call it the life story of a mango, but we took a mango that has a very complicated life journey from maturing on trees, then getting picked from farm crews going to a packing house, then getting shipped by airlanders to the United States, and by the time it arrives in the U.S., it's been a long process. And wanted to see if we could trace those mangoes back to source when I was working at a very large global retailer. And it took that retailer six days, 18 hours and 26 minutes to trace that package of sliced mangoes that you see at the bottom of that slide back to source, almost seven days. Now that's pretty good because they had pretty sophisticated supply chains. We then did a proof of concept where we started to work with a major technology provider and small farmers and growers in Central and South America scanned a package of mangoes after we were collecting that data on blockchain and we were able to trace those mangoes back to source in 2.2 seconds. That's food traceability at the speed of thought. Now at the FDA, we understand that scaling food traceability solutions is not going to be easy, but last year we issued a proposed rule and we are on track to issue a final rule for food traceability next year. A key components of that rule are defining what we call the key data elements. What are the data elements that need to be tracked for food such as where the food was produced or are used by date or a lot code, as well as critical tracking events. What are the types of changes that need to be tracked? Whether a food is harvested or whether it's processed. And so we believe this food traceability rule is the foundation for us to allow a new future of tech-enabled food traceability. Let me give you another example where we're leveraging technology for this new era of smarter food safety and that's one using artificial intelligence. Again, it's not about AI, it's about the business problem that we're trying to solve. If you pause to think about it, Americans eat foods from all around the world. It is a global food system. In some categories, it's fairly low, but in others, extremely high. A good example is seafood. About 94% of the seafood Americans consume comes from abroad. That's literally tens of millions of shipment lines of imports come in in the United States every year. Tens of thousands of different food skews. And so 300 different ports, I can tell you it's a challenge. And you can imagine for data scientists like some of you listening in today, it also represents opportunities. So we did a proof of concept last year where we took our existing, some overlaid it with AI and machine learning functionality. Two years of retrospective seafood shipments that we wanted to see, and that would increase our predictive capabilities of finding which containers of the tens of millions that come across our shores every year might have violent products. And lo and behold, our proof of concept was very, very successful and that we are now launching into a pilot when we're testing the technology or AI function in the field. Let me close with this idea because I think the last speaker did a pretty good job of saying really it's not about distributed ledger technology alone, it really is about a different future. And I like to say, I think distributed ledger technology is going to be a game changer along the term on how companies do compliance, how regulatory agencies do oversight. And I have to say, it's going to change the compliance paradigm. If you pause to think about it, let me describe it in 20th century, whether you work in the public or private sector, compliance was largely driven through writing rules, regulations and standards for two things, facilities and the assets that those facilities produce in my case, food. And so we would write rules and good manufacturing practices for facilities. We would write standards of identity or specifications for the food products assets. And the way compliance was checked, you send inspectors in to do inspections of a facility, you might pull samples of a food product and test it to see if it meets standards or specifications. But we are changing and this is where I'm so excited about the future of compliance and food safety oversight to a world where we no longer have to rely on rules that are paper written and inspections or tests that are very infrequent. To a world with the ability to give facilities and foods, both assets a digital footprint or a voice. You can see through things like sensor technology, IoT, leveraging machine learning and blockchain as a trusted platform where we can now not only track and trace those assets but monitor them in real time. And so that's what I think the future looks like. And so in the 10 minutes I had with you, I wanted to share some real world examples where USFDA is looking at leveraging technology to modernize the way we do compliance or food safety oversight. It's not unique to the public sector, the private sector is taking this approach. And I wanted to end on this note that I think that the future is really bright. I would also say that just having lived through the global pandemic, we know that the virus that causes COVID-19 is not transmitted by food nor food packaging, but it did challenge the food system because worker illnesses and supply chain continuity are two sides of the same coin. And what we've seen is that technology such as distributed ledger technology, we believe could play a role in creating a 21st century food system that is stronger and more resilient, that will be good not only in the course of normal times, but certainly in the time of crisis. And so with that, we look for your questions and engaging with you more importantly. This idea that together we can create a digital, more traceable and safer food system that's better for consumers. Thanks, Brian. Thank you, Frank. I really agree to see the work that you're doing and the thinking you're bringing to the federal government, which I'm sure has ripple effects elsewhere as well. And we've been engaging since you worked for that certain large retailer. And obviously this is work that's been building up for years. And you've worked now both in the private sector setting as well as in the public sector on food traceability on DLT and other technologies. What's the right role for government to play? What role do you see it playing in an enterprise blockchain network? Do you see them as kind of letting the private sector sort it out and being kind of out here and just saying, okay, these reports perhaps maybe they're more auditable, or do you think they might actually run nodes on these production networks and participate in the transactions on the network? It's a great question, Brian. I like to tell a story. Before I joined yesterday, I was working at the World's Largest Retailer and I remember being on the Hill at a hearing with Congress and where they're asking questions about blockchain technology and they asked that same question. And I remember three years ago, not that long ago, I said, hey listen, telling political leaders, stay out of this, let the innovation happen, don't stifle it, don't slow it down. But I can tell you now that I find myself on the other side of the fence, I have a very different answer. I do think there's a role for the public sector. Right now, as you can see, at least on food traceability where the agency has started is writing a rule. Or what are the types of foods that require better food traceability? What are the key data elements that are important? And what are the tracking events? I think longer term as these distributed ledger ecosystems evolve, I think longer term. First of all, let's get, let's make it scale. And let's get better tracking and tracing of foods. But longer term, I do see a government playing the role in a distributed model of trust, where you have nodes that could be run by public sector entities, nodes that are run by academic institutions and roles run by the private sector ecosystems. And so I think a distributed model of trust like that is really important for the 21st century. I like to say, if you think about the financial prices that occurred, you know, now almost greater than a decade ago, if you think about political scandals, if you think about E. coli and runway lettuce, they all have the same thing in common, which is a lack of consumer trust, trust bust. And so the idea that we could create these digital ecosystems where they're distributed models of government being involved in them as well as other institutions, I think probably what society is going to toy with in the future. Do you think there's ways that these networks, I mean, we talked touched a little bit on in my intro on the ways people were starting to deploy them, but what do you think from what you have learned about? Actually, before I ask that question, let me just emphasize for the folks watching this through Hopin, please feel free to submit some questions for that we'll cherry pick the better ones and bring them up before the half hour mark. But if you have questions for Frank, please feel free, I'll try to monitor those questions. And it'd be great to have that as a part of this. But before we dive into that, what do you think from your work with food safety you've seen as things that we could have done better or perhaps we started to do a little bit but should have done a lot more in the response to the pandemic? And maybe just thinking about if we ever, I mean, knock on wood heaven forbid, like had a resurgence or had another one of these, what might help us be in a better position to respond to that from a supply chain traceability point of view? Yeah, it's another good question. You've been working on food for a long, long time now. And I like to say that we just experienced with the pandemic, the virus wasn't transmitted by food, Brian. It was the biggest test we've seen on the food system in a hundred years. There's no question about it. And in the early days of the pandemic, as you know, we were asking consumers to shelter in place. And before they did that, they were running the grocery stores and buying products and hoarding. And we had the equivalent of what I call seven Thanksgiving holidays all in a row. So we had out of stocks early on. And then we started shutting down, as you know, institutions that produce food, whether they were restaurants or hotels or theme parks. And so shortly thereafter, we saw supply chain imbalances with food that was held up in those types of institutions, not making its way to retail. And it wasn't that we didn't have enough food, we just had supply chain imbalances and logistical issues. And so what's become very clear is that for the 21st century, those supply chains that were digitized and can share information and were a little bit more nimble behaved and got through it a little bit better. So I think the lesson learned for me is that digitalization of food. And we know, Brian, there's a reason why food has lag compared to other supply chains margins. But I think this idea of digitizing food and how it can strengthen the food system is an idea whose time has come. Because we needed to have greater visibility of where food was and where were the bottlenecks. And we needed to share information more rapidly. And the fact that we weren't as digital and as collaborative as we can be as such to redistributed and centralized ecosystem. I think, you know, we're looking back, some of us predict that would have helped us get through the pandemic better. But I, this idea is not only good for, as I said, a time of crisis, I think it's good for normal times, you know, the ability to optimize supply chains, make them more sustainable to make them safer. Yeah. And well, so much of the focus is on farm to table and trying to source food from as close to you as you can, which is great. I raise chickens and I eat the eggs for my chickens whenever I can. I obviously food networks are global these days. In what way do you and yourself work with your peers and other governments around the world and coordinate on this topic of blockchain technology? Are you sensing some receptivity from other governments to join in? Do you think these networks become global networks that governments join as peers? Yeah, I do. So we collaborate with our counterparts in other nations quite regularly. And some of them, for example, have already done pilots using distributed ledger technology for few traceabilities. The UK FSA is a good example. We regularly talk with our neighbors to the north and to the south and all over the world. My feeling is that this idea, because of the new tools that we have today where we no longer have to track goods on paper one step up and one step back, everybody's interested in better tracking of assets such as food. I think there's a realization that distributed ledger technology, as I mentioned, because some of the features that can be centralized and distributed, you know, concepts of democratizing information and consensus, all of that makes it very attractive and nations around the world are interested in it. I think it begins with laying the foundation, the data elements, the tracking events, and I think distributed ledger technology would be a natural leader. Because when you have such a large food system, it is enormous. Sometimes people come talk to me about distribution systems and we all know they're interested in blockchain, but they're very simple when you compare them to food. Food system is enormous and it will continue to be large and distributed and decentralized. So I think we're going to see it pick up. I suspect that we're going to see food traceability legislation increase around the world and the way people comply will increasingly be through digital technologies and I think blockchain will probably be at the head of fact. Actually, that ties into a question asked by Chris Gabriel. Let me just read that. Thanks for the great presentation, Frank. Will the FDA, these are his words, will the FDA rule be general in nature regarding traceability or will it actually mandate the use of specific technologies like blockchain? Do you think it'll get that particular? Yeah, I think it's a matter of time. The proposed rule that we've written was given to us by Congress or Congress specifically said that we were not to mandate any type of digital technology or any single type of technology. But I do feel just defining those data elements is really critical because you've heard a lot today talking about interoperability. I sit back and say, hey, I've been chasing this holy grail of food traceability for 30 years. I think we're closer than ever before. But why hasn't it failed, Brian? And I think there's a couple of things. One is we didn't have the digital technologies, a centralized database, you're never going to get the large global food system in a centralized database. It's just not going to happen. And so that's why I'm so interested in distributed learning technology standards. People were doing food traceability different ways. And so when we created standards, and I think, but there's other challenges now too, and as you heard today, as I think governance models are going to be critical because we're going to see various ecosystems. I think previously there's a couple of them as islands. And I also think, believe it or not, I hope that in this conference, you guys spent a lot of time talking about it, is data sharing. You know, we know with blockchain networks, you can permission, but let me tell you, I still see, and since I've been in the public sector, I see this as a bigger challenge now than when I was in the private sector where a big retailer could demand suppliers to share information. I think sharing of data is still a hurdle that we have to get through. So the take home message is we won't, at least at this juncture, mandate any particular technology. But I think there's some hurdles. And I think some of the hurdles are not the hard stuff, the tech component. I think it's a soft stuff. The human element of working with blockchain systems. I'll provide another data point in this though, which is in India a couple of years ago, the telecom regulators issued a rule around tracking of spam preferences for mobile phone users. They wanted a decentralized system. So in the regulation, they actually specified a blockchain system must be implemented for tracking of individual preferences in a way that was portable between the major carriers. They went ahead and built this. In fact, we've got a presentation on it later in this conference. The different major telcos work together on a decentralized network built on hyperledger fabric and they've been in production now. And it's kind of remarkable. Sometimes I'm never a fan of being specific about technology and regulation because usually that works against the interest of innovation, but I think in some ways that can accelerate it. You mentioned quite a bit the importance of open standards as part of this kind of international cooperation and cooperation with industry. What role do you think open source software plays in that? In fostering that development and harmonizing these operations. I mean, I know government interest and adoption of open source software has increased over the years, but how much of it is in front of mind for the regulators in this space and people thinking about how infrastructure gets built? Yeah, for me, it's really critical right now and especially when you think about infrastructure being built that's used by a lot of entities in a regulated ecosystem like food. So I think it's a necessity. I relate it to this concept of transparency and trust. Just being very open with the industry that you regulate and the consumers that you're doing something in an open and transparent way. So I think it's critical, Brian. Okay, okay, great. And I think there's a related question too, which is a little bit on the topology of these different networks as they evolve. I think some people might imagine that there will be one global network for a given commodity, for diamonds or rice or leafy green vegetables. And certainly then you'd have one traceability mechanism, it'd be easy to harmonize. Do you think that's likely to happen? Or do you think we're likely to see different blockchain networks and how do they map? Do they map by clusters of goods? Do they map by geography or regulatory structure? And then I think a related question to that is, actually I'll ask the related question later because that was a submitted question, but go ahead and start with that. It's great. It's a bit of speculating and looking at crystal ball and imagining what's happening in the future, but if you just look at what's happening right now, you know, compared to where I was when we first started the blockchain ecosystem where we were tracing food three years ago, we now have a whole host, I can't even tell you how many different blockchain ecosystems emerging where they're doing proof of concepts and they're moving beyond proof of concepts. A lot of these are in production now where they're tracing foods. And so I think we have to think about it in a way at least the agency that there's going to be, there varies what I call ecosystem, blockchain ecosystems. I think they're probably going to emerge around business partners, people that are doing business. I think in some instances it might be around commodity, but I don't think there's going to be a one system fits all clearly. I don't think there's going to be one system fits all for a lot of commodities. And we'll see how it evolves over time, but I think there will be multiple blockchain ecosystems for food. And that's where it's critical that we have them in a problem there. And it's not going to be just on the data standard, it's governance as well. Right. Well, this is where I lead into Arun's question, which is from a regulatory point of view, what is your take on multiple island networks as he calls them and connecting them? What works in this space and what doesn't? I mean, have you looked at this, do you think there'd be some policy formed on how to connect these distinct networks? Yeah, no, if people have good ideas on this, let me know, I've spent a lot of time thinking about that, because I think that's what the future looks like and we have to figure out how to get across that. Not everything the agency does has to do by rulemaking. So I had been contemplating the idea of writing some guiding principles how I think these islands should evolve and what type of governance structure should be there for them to interoperate. We're going to have to cross this bridge. I think this is going to be one of the most challenging bridges that the technology won't be the challenge. How do different systems work together? We even need to find the right metaphors. I still struggle, is it an island? Is it a neighborhood? Cause it's kind of like cooperating peers, but is that a cul-de-sac? I don't know, we'll have to work on that. Maria Munaro, shifting back a little bit to talking about food and talking about really the impact on farmers and the last mile she calls it. How do you think that actually she calls it the first mile? How do you think the first mile can be resolved? Where it might involve farmers without access to technology or connectivity issues. How can they become aware and incentivize to participate in these kinds of networks? How does it actually roll out to them? It's a great question. And we spent a lot of time thinking about this, but I didn't, I'm the public sector. And it's this idea, and you're familiar with these terms, but we really have to sit down and ask yourself, how do you create shared values so that everybody gets in? You can't create this concept of a digital vibe that I heard, I'm a firm believer that these types of technologies are going to be good for food producers of all sizes. In fact, I think it's a game changer for small producers and I think it'll be very good for small local producers because I think it could result in some market access that they didn't. You've heard the stories that small farmers in Africa, one of the best help then was just when they got mobile phones. The mere fact that they had them, oh, not a hoe, not a tractor, a mobile phone connected them to buyers. And so just think about the power that this technology has. But I think we have to think about how do you create shared value and how do you get small players in? For farmers in particular, I believe it's market access to visibility, it's the ability for them to tell their stories. And I'm convinced having talked to a lot of small farmers and farmers in general, when we start connecting payment, rapid payment, it'll be beneficial for them. In a food safety scare, for example, what I'm very interested in, if you think about some of these outbreaks that have happened or public health officials come out and say, for example, don't eat any romaine lettuce until we identify the source of the contamination. And when you find the source of contamination, at least in the spinach outbreak of over a decade ago, it was one producer, one day's production, one lot. You destroyed a lot of farmers' livelihoods because you couldn't track and trace quickly. And so I think the benefits are there. I do think another reason why it hasn't scaled though, Brian, is we have to get more creative in the economic models that causes the scale. And so I would challenge your community to say, how do you come up with creative economic models that allow these ecosystems or islands or cul-de-sacs to scale? And right now we're running a challenge, the FDA is. So those that are interested can visit precision.fda.gov but we're calling a low to no cost food traceability challenge. And so we're looking for people to come up with the models because we know the technology works, but we need a little bit more creativity around the economic models. It's interesting to see if there's ways to deploy these networks in such a way where the small-hold farmer, the organic farmer, others can join a system, even if they're not part of a big cooperative or a big ag and a company could say, I just want to write to the ledger, here's the product I'm shipping, here's the serial numbers and have the local consumer who's just one hop away or two hops away be able to verify that and also get the notice of product recalls and that sort of thing. Thinking about how to go down market, but really how to decentralize this that feels important. Just have time for one more question. You guys regulate so much of what gets bill out there. I think the number was 20 cents on the dollar spent by consumers on food, on drugs, on cosmetics and all these different things. When you talk to your colleagues at the FDA and all these different groups beyond even food about blockchain technology, how often comes to mind, cryptocurrencies and energy burn and speculative financial instruments, these kinds of things that I think are part of the spectrum, but how much does that create barriers to diving into what's possible with the technology? Yeah, no, that's a great question. There's been a real sea change on how, I think, folks within the agency think about it. My brother and fellow regulators, I can tell you when I first joined the agency, which was two and a half years ago, even financial disclosures, if you don't have cryptocurrencies, they didn't even know what you're talking about. But I will tell you right now today, cryptocurrency is not what comes to mind inside the agency. We have a couple of work streams involving blockchain technology. We certainly have the Drug Supply Chain Security Act and many of you know there are pilots that are being done for drugs. You've heard about vaccines. There's a great system being run by Cedar here at FDA on sharing of health records on distributed ledger technology. And so I can tell you today, it's really about tracking assets and sharing of information in a trusted way and people no longer think of cryptocurrency. Those days are behind us, I think, in federal service. That's great. Well, let's keep them away from Miami then. With that, Frank, thank you so much for giving us your time. And we'll continue to work with the FDA going forward. Yeah, please. Thank you. Keep up the good work. All right. Thanks so much.