Hyperledger Foundation Hyperledger Global Forum 2021, 9 Jun 2021

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From YouTube: Keynote: The Role of Emerging Technologies, such as DLT, in Ushering in the Ne... Frank Yiannas, FDA

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Keynote: The Role of Emerging Technologies, such as DLT, in Ushering in the New Era of Smarter Food Safety - Frank Yiannas, Deputy Commissioner for Food Policy and Response, Food and Drug Administration

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A

Well, thank you, brian and good morning from the u.s, regardless of where you're at around the.

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World, it's a real pleasure to be participating in this hyper ledger event, um as you heard from.

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The introduction I work at the fda, but I spent most of my career in the private sector and I've.

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Been with fda for a couple of years now, what I was hoping to do today is talk about fda's new.

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Era of smarter food safety and the role that new emerging technologies, such as.

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Distributed ledger technology will play in that uh right at the outset. You might be saying well.

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Why is there a public health food guy at a hyperledger event? uh Well, number one. I would.

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Say we have more in common than you think if I were to ask the question how many of you eat food.

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If we were in a live audience, all of you would raise your hand and number two I've long.

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Recognized the important role that distributed ledger technology and blockchain can play because.

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Of work that I did in the private sector, but let me begin with this premise and I think you.

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Heard a lot of it already this morning, uh the world around us is changing pretty rapidly. We've.

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Heard this quote that never before has the rate of change been this fast and never again will.

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Be this slow again? Well, that's true! For food, too, you think about the food system. It's been changing.

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From the beginning of time, at the beginning of time, humans were hunter and gathers. They then.

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Started domestically plants and animals, we had the industrial farming revolution in the early.

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1900S and around the 1980s, when I was going to the grocery store with mom and dad there were about.

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15 000 food skis different food products. How many do you think there were at the turn of the century.

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There were close to 50 000 different food items and where are we going? We're really.

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Going to the place where the food system will be an endless shelf, where consumers can go.

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Online or to their favorite grocery store, whether it's a brick and mortar or romney channel and get.

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Anything that they want from anywhere around the world at any time granted the pandemic has.

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Presented challenges but we'll get through the pandemic, and I believe that supply chains will be.

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Stronger and more resilient than ever, the other thing that we realized the.

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Food system is changing, the reality is, as we speak, we're seeing foods being reformulated.

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We see new foods being realized, whether it's cell culture, plant-based foods or gene-edited foods.

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And we're seeing a lot of change, I believe we're literally in the midst of the food revolution.

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And to succeed in these modern times, it's the fda's opinion and many.

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In the food industry's opinion that we need more modern approaches, it's time to leverage and so.

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At fda, we've created a long tenure view of how we want to modernize the work that we do overseeing.

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Food for the nation and we're calling it a new era of smarter food safety which will continue to be.

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Ruled and law based, but increasingly technology enabled now I'm going to give you two examples of.

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The few minutes that we have together today of real work that the agency is doing using.

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New and emerging technologies, one is distributed, ledger technology of watching.

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I always like to emphasize as a public health guide. For me, it's never about the technology.

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It's really about what is the public health or business challenge that we're trying to solve.

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And when it comes to distributed ledger technology, it's this. The reality is even the biggest of.

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Companies don't really have a lot of visibility into how food they buy gets produced, transported.

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And ultimately, ends up on their shelves. It's pretty difficult because we have a very.

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Large distributed and decentralized food system, in fact, oftentimes people talk about the food system.

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As a food chain- and I try not to do that because it's not linear in fashion at all, in fact, as I.

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Learned and studied about blockchain, I thought you know the way the food system is created very.

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Decentralized and distributed it models, blockchain technology, and that's where I became interested.

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We've all seen food scares were because we would have an inability to track and trace foods quickly.

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It results in, for example, consumer advisories, where the fda or cdc might say, don't eat any.

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Product until we find the source of the outbreak- and sometimes it can take.

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Weeks for us to do that when I was in the private sector, I did a proof of concept to illustrate why.

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I think the power of blockchain is so great. Some of you may have heard it. I call it the.

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Life story of a mango, but we took a mango that has a very complicated life journey.

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For maturing on trees, then getting picked from farm crews going to packing house then.

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Getting shipped by airlander seat to the united states and by the time it arrives at the u.s.

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Process I wanted to see if we could trace those mangles back to source when I was working at a.

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Very large global retailer and it took that retailer six days, 18 hours and 26 minutes to.

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Trace that package of sliced mangoes that you see at the bottom of that slide back to source.

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Almost seven days now, that's pretty good because they had pretty sophisticated supply chains.

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We then did a proof of concept where we started to work with a major technology provider and small.

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Farmers and growers in central and south america uh scanned a package of mangoes after we were.

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Collecting that data on blockchain and we were able to trace those mangoes back to source in 2.2.

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Seconds, that's food traceability at the speed of thought. Now at the fda, we understand that scaling.

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Food traceability solutions is not going to be easy, but uh last year we issued a proposed rule.

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And we are on track to issue a final rule for food traceability next year. Key components of.

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That rule are defining what we call the key data elements. What are the date elements that need to.

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Be tracked for food, such as where the food was produced or used by date or a lot code.

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As well as critical tracking events, what are the types of changes that need to be tracked, whether.

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A food is harvested and whether it's processed, and so we believe this food traceability- will.

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Is the foundation for us to allow a new future of tech, enabled food traceability.

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Let me give you another example: we're leveraging technology for this new era of smarter food safety.

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And that's one using artificial intelligence. Again, it's not about ai! It's about the business.

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Problem that we're trying to solve, if you pause to think about it, americans eat foods from all.

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Around the world, it is a global food system in some categories it's fairly low, but another is.

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Extremely high, a good example is seafood about 94 of the seafood americans consume comes from abroad,.

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That's literally tens of millions of shipment lines of imports coming into the united states.

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Every year, tens of thousands of different food skus and so uh 300 different ports. I can tell.

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You it's a challenge and you can imagine for data scientists like some of you listening and today.

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It also represents opportunities, so we did a proof of concept. Last year where we took our.

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Existing overlaid it with ai and machine learning functionality, two years of retrospective seafood.

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Shipments and we wanted to see if that would increase our predictive capabilities of finding.

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Which containers of the tens of millions that come across our shores every year might have violated.

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Products and lo and behold, our proof of concept was very, very successful and we are now launching.

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Into a pilot and we're testing the technology, our ai function in the field, uh let let me close with.

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This idea, because I think the last speaker did a pretty good job of saying. Really it's not about.

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Distributed ledger technology alone, it really is about a different future and I like to say.

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I think distributed ledger. Technology is going to be a game changer longer term.

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On how companies do compliance, how regulatory agencies uh do oversight, and I have to say it's.

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Going to change the compliance paradigm, if you pause to think about it, let me describe in the.

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20Th century, whether you you work in the public or private sector, compliance was largely driven.

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Through writing, rules, regulations and standards for two things: facilities and the assets that.

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Those facilities produce, in my case food, and so we would write rules and good manufacturing.

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Practices for facilities, we would write standards of identity or specifications for food products.

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Assets and the way compliance was checked. You send inspectors in to do inspections of a facility.

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You might pull samples of a food product and test it to see if it meets standards or specifications.

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But we are changing, and this is where I'm so excited about the future of compliance and food.

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Safety oversight to a world where we no longer have to rely on rules that are paper written.

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And inspections or tests that are very infrequent to a world with the ability to.

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Give facilities and foods both assets, a digital footprint or a voice. You can see through things.

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Like sensor technology, iot leveraging machine learning and blockchain as a trusted platform.

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Where we can now not only track and trace those assets but monitor them in real time, and so.

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That's what I think the future looks like and so in the 10 minutes I had with you. I wanted to share.

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Some real world examples where usfda is looking at leveraging technology to modernize the way we do.

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Compliance or food safety oversight, it's not unique to the public sector, the private sector.

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Is taking this approach, and I wanted to end on this note that I think the future is. It was really.

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Bright, I would also say that just having lived through the global pandemic, we know that the.

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Virus that causes covid19 is not transmitted by food nor food packaging, but it did challenge the.

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Food system, uh because worker illnesses and supply chain continuity are two sides of the same coin.

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And uh what we've seen is that uh technologies such as distributed ledger technology. We believe.

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Could play a role in creating a 21st century food system that is stronger and more resilient? That.

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Will be good not only in the course of normal times, but certainly in the time of crisis and.

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So with that, uh we look for your questions and engaging with you more importantly, this idea that.

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Together, we can create a digital, more traceable and safer food system. That's better for consumers.

A

Thanks brian, thank you frank. I I really agree to see the work that you're doing and and the.

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Thinking you're, bringing to uh to the to the federal government, which I'm sure has.

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Ripple effects elsewhere as well um and we've been engaging since you worked for that certain large.

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Retailer um uh and uh uh obviously this is work- that's that's. That's been building up for years.

B

um And you've worked now, both uh in the private sector setting as well as in the public sector,.

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On food, traceability on on dlt and and other other technologies, what what's the right role.

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For government to play, uh what role do you see it playing um uh in an enterprise, blockchain network.

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um You know like: do you see them as uh kind of letting the private sector sort it out and being.

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Kind of out here and just saying: okay, these reports, perhaps maybe they're more auditable.

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Or do you think they might actually run nodes on these production networks and participate in the.

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Transactions on the network, it's a great question. Brian. You know I like to tell a story before I.

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Joined yesterday I was working at the world's largest retailer and I remember being on the.

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Hill uh at a hearing with congress, where they're asking questions about [, __ ] technology and they.

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Asked that same question- and I remember three years ago not that long ago I said: hey, listen.

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Telling political leaders stay out of this, let the innovation happen, don't stifle, it don't slow. It.

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Down, but I can tell you now that I find myself on the other side of the fence. I have a very.

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Different answer, I do think, there's a role for the public sector right now, as you can see at least.

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On food traceability, where the agency has started is writing a rule, but what are the types of foods.

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That require better food traceability. What are the key data elements that are important uh and.

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What are the tracking events, I think, longer term, as these distributed ledger ecosystems evolve? uh I.

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Think longer term: first, let's get let's: let's make it scale and let's get better tracking and tracing.

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Of foods but longer term, I do see government playing a role in a distributed model of trust.

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Where you have nodes that could be run by public sector entities, nodes that are run by academic.

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Institutions and roles run by the private sector, ecosystems, and so I think, a distributed model of.

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Trust like that is really important for the 21st century. I like to say if you think about the.

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Financial prices that occurred- you know now almost greater than a decade ago, if you think about.

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Political scandals, if you think about e coli and remain lettuce, they all have the same thing in.

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Common, which is a lack of consumer trust, trust us, and so the idea that we could create these.

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Digital ecosystems, where they're distributed models of government being involved in them.

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As well as other institutions, I think probably what society is going to toilet in the future.

B

Do you think, there's ways that these networks I mean we talked touched a little bit on in my.

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Intro on the ways people were starting to deploy them, but what what do you think from what you.

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Have learned about uh actually before I ask that question, let me just emphasize for the.

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uh Folks, watching this uh through hop in, please feel free to submit some questions. I I uh for.

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uh That will will cherry pick the better ones and and bring them up before the uh the the.

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Half hour mark, um but if you have questions for frank, please feel free I'll. Try to monitor those.

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Questions uh it'd be great to have have that as a part of this, um but before we dive into that, I.

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uh What do you think from your work with food safety uh you've seen as things that you know.

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We could have done better or perhaps we started to do a little bit, but should have done a lot more. I.

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I, in the response to the pandemic, um uh and and maybe just thinking about if we ever I mean knock.

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On wood, heaven forbid like had a resurgence or add another one of these. What what might help us.

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Be in a better position to respond to that from a from a supply chain, traceability, point of view.

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Yeah, it's another good question. You know I've been working on food for a long long time now and.

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I like to say that just experienced with the pandemic, while the virus wasn't transmitted by.

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Food by and it was the biggest test we've seen on the food system in 100 years- there's no question.

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About it in the early days of the pandemic, as you know, we were asking consumers to shelter in place.

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And before they did that they were running the grocery stores and buying products and hoarding.

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And we had the equivalent of what I call seven thanksgiving holidays all in a row, so we had out.

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Of stocks early on and then uh we started shutting down. As you know, institutions that produce food.

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Whether they were restaurants or hotels or theme parks, and so shortly thereafter we saw supply.

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Chain imbalances with food that was held up in those types of institutions, not making its way to.

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Retail and it wasn't that we didn't have enough food, we just had supply chain imbalances. Some.

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Logistical issues, and so what's become very clear- is that for the 21st century those supply chains.

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That were digitized, they could share information and were a little bit more nimble, uh behaved and.

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Got through it a little bit better, so I think the lesson learned for me is that digitalization of.

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Food- and we know brian there's a reason why food has lagged compared to other supply chains, margins.

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But I think this idea of digitizing food and how it can strengthen the food system is an idea whose.

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Time has come because we needed to have greater visibility of where food was and where were the.

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Bottlenecks and we needed to share information more rapidly and the fact that we weren't as.

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Digital and as collaborative as we can be as such, through a distributed decentralized ecosystem. uh I.

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Think you know looking back, some of us predict hey that would have helped us get the pandemic better.

B

But I this idea is not only good for, as I said, a time of crisis, I think it's good for normal times.

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You know the ability to optimize supply chains make them more sustainable to make them safer.

B

Yeah and while so much of the focus is on farm to table and trying to source food from as close to.

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You as you can, which is great. I I raise chickens and I I eat the eggs for my chickens uh whenever.

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I can um I obviously food networks are global these days. um In what way do you and yourself.

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Work with your peers and other uh governments around the world uh and coordinate on on this.

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Topic of blockchain technology are you sensing, some receptivity from other governments to to.

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Join in, do you think these networks become global networks that that that governments join as peers.

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Yeah, I I do so. We collaborate with our counterparts in other nations quite regularly.

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uh And some of them, for example, have already done. uh Pilots using distributed ledger technology from.

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Traceabilities, the uk fsa is a good example. uh We regularly talk with our neighbors to the north and.

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To the south and all over the world, um my feeling is that this idea of because of the new tools that.

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We have today where we no longer have to track goods on paper, one step up and one step back.

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Everybody's interested in better tracking of assets such as food, I think, there's a.

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Realization that distributed ledger technology, as I mentioned, because some of the features have.

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Been decentralized and distributed, you know concepts of the democratizing information and.

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Consensus, all of that makes it very attractive and nations around the world are interested in it. I.

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Think it begins with laying the foundation the data elements, uh the tracking events.

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And I think distributed ledger technology would be a natural leader because when you have such a.

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Large food system- it is enormous, sometimes people come talk to me about distribution systems and.

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We all know they're interested in blockchain, but they're very simple when you compare them to food.

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Food system is enormous and it will continue to be large and distributed decentralized, so I think.

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um We're going to see it pick up. I suspect that we're going to see food traceability legislation.

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Increase around the world and the the way people comply will increasingly be through digital.

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Technologies- and I think blockchain will probably be ahead of that, actually, that that uh ties into.

B

A question asked by chris gabriel: uh let me just read that, thanks for the great presentation, frank.

B

Will the fda will this? Is these? Are his words? Will the fda rule be general in nature? Regarding.

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Traceability, or will it actually mandate the use of specific technologies like blockchain? Do you.

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Think do you think it'll get that that particular yeah? You know, I, I think it's it's a matter of time.

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The rule that we've, the proposed rule that we've written was given to us by congress.

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So congress specifically said that we were not to mandate any type of digital technology or.

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Any single type of technology- but I do feel just defining those data elements- is really critical.

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Because you've heard a lot today talking about interoperability, I I sit back and say: hey I've.

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Been chasing this holy grail of food traceability for 30 years, I think we're closer than ever before.

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But why hasn't it failed ryan and I think there's a couple of things one is we didn't, have the.

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Digital technologies, a centralized database you're never going to get a large global food system in.

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A centralized database, it's just not going to happen, and so that's why I'm so interested in.

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Distributed larger technology standards, people were doing food, traceability, different ways and.

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So we've created standards I think, but there's other challenges. Now too, as you heard, you know.

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Today is, I think, uh governance models are going to be critical because we're going to see various.

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Ecosystems, I think previously there's two of them as islands, uh and I also think believe it or not.

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I hope that in this conference you guys spend a lot of time talking about it is data sharing.

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You know we know with blockchain networks, you can permission, but let me tell you, I still see.

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And since I've been in the public sector, I see this is a bigger challenge now than when I was.

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In the private sector, where a big retailer could demand suppliers to share information.

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I think sharing of data is still a hurdle that we have to get through.

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So the take-home message is we won't at least at this juncture mandate, any particular.

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Technology, but I think, there's some hurdles and I think some of the hurdles are not.

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The hard stuff, the tech component, I think it's the soft stuff, it's the human element, the work.

B

I'll provide another data point in this, though, which is uh in india a couple years ago. The.

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Telecom regulators, I issued a rule around um uh tracking of spam preferences for mobile phone.

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Users, they wanted a decentralized system, so in the regulation they actually specified a blockchain.

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System must be implemented for tracking of individual preferences in a way that was portable.

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Between the the major carriers, they went ahead and built this. uh In fact, we've got uh uh some a.

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Presentation on it later later, in this conference, um the different uh major telcos work together.

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On a decentralized network built on hyperledger fabric and they've, been in production now, and it's.

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Kind of remarkable um you know sometimes I'm never a fan of like being specific about technology and.

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Regulation because usually that works against the interest of innovation. But I think in some ways.

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That can that can accelerate it. um You mentioned quite a bit uh uh the importance of open standards.

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As part of this kind of international cooperation and cooperation with industry, what role do you.

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Think open source software plays in that in fostering that development and harmonizing.

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These operations, I mean, I know, government interest and adoption of open source software, has increased.

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Over there over the years, uh uh but uh how much of it is in front of mine for.

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The regulators in this space and people, thinking about how infrastructure gets built.

A

Yeah, for me, it's really critical right now and especially when you think about.

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Infrastructure being built, that's used by a lot of entities and regulated ecosystems.

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Like food, so I think it's a necessity. I relate it to this concept of transparency and trust.

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um You know just being very open with the industry that you regulate and the consumers.

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That you're doing something in an open and transparent way. So I think it's critical brian.

B

Okay, okay, great um you know, and and there's I think, there's a related question too, which is.

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A little bit on the topology of these different networks as they evolve. uh I think some people.

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Might imagine that there will be you know one global network for a given commodity. You know.

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uh For diamonds or rice uh or leafy green vegetables, um I you know, and certainly then you'd.

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Have one traceability mechanism it'd be easy to harmonize? um Do you think that's likely to happen.

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uh Or do you think we're likely to see you know different different blockchain networks and how do.

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They map do they map by clusters of goods. Do they map by geography or regulatory structure, and then.

B

I think a related question to that is uh actually I'll. Ask the related question later, because that.

B

Was a submitted question, but go ahead and start with that? It's great! You know it's! It's a bit of.

A

um Speculating and looking at crystal ball and imagining what's happening in the future. But.

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If you just look at what's happening right now, you know compared to where I was when we first started.

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The blockchain ecosystem, where we chose some foods uh three years ago, we now have a.

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Host, I can't even tell you how many different blockchain ecosystems, emerging or they're doing.

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Proof of concepts and they've moved beyond proof of concepts. A lot of these are in production. Now.

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Where they're tracing foods- and so uh I think we have to think about it in a way, at least.

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The legacy that there's going to be there there is what I call ecosystem, blockchain ecosystems,.

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um I think they're probably going to emerge around uh business partners, people that are.

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Doing business I think in some instances it might be around commodity, but I don't think there's.

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Going to be a one system fits off. Clearly I don't think there's going to be. One system fits all for.

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A lot of companies- and you know we'll see how it evolves over time, but I think there'll be multiple.

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Blockchain ecosystems for food and that's where it's critical, that we have them and it's not going.

B

To be just on the data standards, it's governments as well right well, this is where I lead into a.

B

Roon's question, which is um from a regulatory point of view, what is your take on multiple.

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Islands networks, as you call them, calls them and connecting them. uh What works in this space and.

B

What doesn't I mean, have you have you looked at this? Do you think there'll be some policy formed.

B

On like how to connect these distinct networks yeah, I know if people have good ideas on this. Let.

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Me know I've spent a lot of time. Thinking about that, because I think that's what the future looks.

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Like and we have to figure out how to get across that- I think you know um not everything. The agency.

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Does has to do by rulemaking, so I have been contemplating the idea of writing some guiding.

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Principles, how I think these islands should evolve and uh what type of governance structure should be.

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There for them to interoperate, but uh we're gonna have to cross this bridge. I think this is gonna, be.

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One of the most challenging bridges- the technology- won't be the challenge it will be. How do you film.

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Ecosystems work together. We even need to find find the right metaphors. I still struggle. Is it.

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An island is it a neighborhood, you know because it's kind of like you know cooperating peers, but.

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Is that a cul-de-sac I don't know? Well, we have to to work on that um maria monaro uh shifting.

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Back a little bit to talking about food and talking about uh really the impact on farmers.

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uh And and the last mile she calls it: how do you think that actually she calls it the first mile.

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How do you think the first mile can be resolved where it might involve farmers without access to.

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Technology or connectivity issues, how can they become aware and incentivize to participate in.

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These kinds of networks: how does that actually roll out to them? It's a great question and we.

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Spent a lot of time, thinking about this- both I didn't in the public sector and it's this idea.

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And you're familiar with these terms, brian, you really have to sit down and ask yourself how do.

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You create shared value so that everybody gets in. You can't create this concept of a digital divide.

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That I heard I'm a firm believer that these types of technologies are going to be good.

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For food producers of all sides, in fact, I think it's a game changer for small futures. I think.

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It'll be very good for small local producers, because I think it could result in some.

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Market access, they didn't you've heard the stories that small farmers in africa, one of.

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The best helped them was just uh when they had mobile phones, the mere fact that they had them.

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Not a hoe tractor, a mobile phone connected them to buyers, and so just think about the power that.

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This technology has, but I think we have to think is think about. How do you create shared value.

A

And how do you get small players and for farmers in particular, I believe.

A

It's market access, it's visibility, it's the ability for them to.

A

Tell their stories and I'm convinced, having talked to a lot of small farmers and farmers in general,.

A

When we start connecting payment payment, it'll be beneficial for them in a food safety scale for.

A

Example, but I'm very interested in if you think about some of these outbreaks that have happened.

A

Public health officials come out and say, for example, don't eat any romaine lettuce until.

A

We identify the source of the contamination and when you find a source of contamination at least.

A

In the spinach outbreak of over a decade ago, it was one producer, one day's production, one block.

A

You destroyed a lot of farmers, livelihoods because you couldn't track and trace quickly, and so uh I.

A

Think the benefits are there. I do think another reason why it hasn't scaled though ryan is. We have.

A

To get more creative in the economic models that cause us to skip, um and so I would challenge your.

A

Community to say how do you come up with creative economic models that allow these ecosystems or.

A

Islands are called the stacks to scale and uh right now we're running a challenge. The fda is.

A

So those that are, they can visit precision.fda.gov that we're calling a low to no cost food.

A

Traceability challenges so we're looking for people to come up with the models, because we.

A

Know the technology works, but we need a little bit more creativity around the economic models.

B

Bitching, you see, if there's ways to deploy these networks in such a way where the smallhold farmer.

B

The organic farmer, uh others can can join a system. You know, even if they're, not part of a.

B

Big cooperative or or big a big ag, you know, company, you could say I just want to write.

B

You know to the ledger: here's the product, I'm shipping, here's the serial numbers and have the.

B

The local consumer, who's just one hop away or two hops away, be able to verify that and also get the.

B

Notice of product recalls and that sort of thing um think about how to go down market but really.

B

How to decentralize this? It feels important um just have time for one more question. I you know.

B

You guys regulate so much of what gets billed out there. I think the number was 20 cents on.

B

The dollar spent by consumers on food on drugs on you know, cosmetics, and all these different things.

B

When you talk to your colleagues at the fda and all these different groups uh beyond even food.

B

About um about blockchain technology, how often comes to mind you know cryptocurrencies and energy.

B

Burn and uh speculative financial instruments, these kinds of things that I think are are.

B

You know part of the part of the spectrum, but I I, uh but how much does that create barriers to.

B

uh Diving into what's possible with the technology yeah. No, that's that's a great question. There's.

A

Been a real sea change on how I think, folks, within the agency, think about it. My brethren fellow.

A

Regulators, uh I can tell you when I first joined agency, which was two and a half years ago, even.

B

Financial disclosures, if you disclose, if you own cryptocurrencies, they didn't even know what you're.

A

Talking about, but I will tell you right now today, um cryptocurrency is not what comes to mind inside.

A

The agency we have a couple of work streams involving blockchain technology. We certainly.

A

Have the drug supply chain security act and many of you know there are pilots that are being done.

A

For drugs you've heard about vaccines, um there's a great system being run by cedar here at fda.

A

On sharing of health records on distributed, ledger technology, and so I can tell you.

A

Today, it's really about uh tracking assets and sharing of information in a trusted way and.

A

People no longer think of cryptocurrency. Those days are behind us. I think.

A

In federal service, that's great well, um let's keep them away from miami. Then.

B

um With that uh frank, thank you so much for uh giving us your time uh and I I will continue.

B

To work with the fda going forward, yeah, please thank you. Keep up there all right thanks! So much.