A Conversation with Frank Yiannas
In an initiative called the New Era of Smarter Food Safety, the U.S. Food and Drug Administration plans to continue efforts to modernize how it honors its commitment to help protect consumers from foodborne illness. The agency plans to incorporate the use of new technologies, tools and approaches as it continues to implement the science and risk-based requirements of the FDA Food Safety Modernization Act (FSMA).
One of the architects of the New Era is Frank Yiannas, a renowned food safety expert and proponent of a more digital and transparent food system. Mr. Yiannas joined the FDA from the private sector in December 2018.
As the Deputy Commissioner for Food Policy and Response, he leads the development and execution of many policies related to food safety, including FSMA implementation and supply chain innovation. He is the primary advisor to the FDA commissioner on activities related to food-related outbreak response, traceback investigations, and product recall activities involving potential threats to human health.
On April 30, 2019, Mr. Yiannas and Acting FDA Commissioner Ned Sharpless, M.D., announced that FDA is developing a New Era of Smarter Food Safety blueprint in which FDA plans to spell out, among other things, how the agency will leverage new and emerging technologies to prevent contamination and rapidly trace the origin of a tainted food to its source.
As internal brainstorming groups generate ideas on how to usher FDA into this new era and the agency prepares for an October 21 public meeting on the initiative, Mr. Yiannas shares his insights on how he envisions the future of FDA’s food safety mission.
Q: What do you mean when you say there will be a New Era of Smarter Food Safety at FDA?
This isn’t just a slogan or a tagline. Instead, it’s a new approach to food safety, one that recognizes and builds on the progress made in the past, but also incorporates the use of new technologies that are being used in society and business sectors all around us. These include blockchain, sensor technology, the Internet of Things, and Artificial Intelligence to create a more digital, traceable, and safer food system. This new approach creates shared value for all stakeholders -- farmers, food producers, regulators, consumers, and the planet.
When you look at how other industries are able to track, through digital means, the real-time movement of planes, ride sharing, and packaged goods, we should be looking quickly to adopt and fully implement these new technologies for food.
That said, while technology is an important part of Smarter Food Safety, it’s more than that. It’s about simpler, more effective and modern approaches and processes. It’s about leadership and creativity. It’s also about working within and outside of FDA to foster a food safety culture that transcends borders between the public and private sector.
Walt Disney famously said, “You can design and create, and build the most wonderful place in the world. But it takes people to make the dream a reality.” That’s how I feel about the work we’re doing. Smarter Food Safety is people-led, FSMA-based and technology-enabled.
Q: Is this Food Safety 2.0? Is it “smarter” in the same way that phones and televisions are ‘smart’?
In a way, yes. We are in the midst of a new revolution in food technology. There will be more changes in the next 10 years than there have been in the past 20 years. Products will be reformulated; new food sources and production approaches will be realized, and the food system will become increasingly digitalized. As an agency – and as food safety professionals - we must be multidimensional, and we must adapt to the changing world around us to protect public health and facilitate innovation.
Q: Why are you so focused on traceability?
In my view, today’s food system is amazing, but it does have one major Achilles heel: A lack of traceability and transparency. You don’t have to look too far to see what a lack of traceability costs us, whether it was the Peanut Corporation of America outbreak, and all the ingredient-driven recalls it caused, to the two outbreaks of E. coli O157:H7 infections tied to consumption of romaine lettuce in 2018.
The second of the E. coli O157:H7 outbreaks, which made people sick in multiple U.S. states and Canadian provinces, essentially emptied all store shelves of romaine lettuce right before Thanksgiving while we were searching for the source of the contamination. Just think about this. At a time when most Americans across the country were sitting down with family and friends to celebrate over food – we had a nationwide food safety crisis. The damage that does to consumer trust is hard to measure.
When it comes to food traceability, some are stuck in a past in which each segment in the food system is responsible for keeping track of food, one step forward to identify where the food has gone and one step back to identify the source. And it’s largely done on paper. However, with the emergence of new digital technologies, the proliferation of the Internet of Things, and the continued advancement of sensor technology, many believe the one-step forward and one-step back model of food traceability is an outdated paradigm for the 21st Century.
There’s no question in my mind that there is a strong public health and business case for better traceability.
Q: In the private sector, you became a champion for the use of blockchain technology to improve traceability. Can you say more about that?
I’ve been chasing the holy grail of digital food traceability solutions for years, and I’ve been unsuccessful in finding it. The emergence of blockchain technology, because of its distributed and decentralized nature that aligns more closely with a decentralized and distributed food system, has enabled food system stakeholders to imagine being able to have full end-to-end traceability. An ability to deliver accurate, real-time information about food, how it’s produced, and how it flows from farm to table is a game-changer for food safety.
For example, I was involved in a pilot that traced mangoes back to their source using blockchain technology, so let me use them as an iconic example here. Mangoes have a complicated supply chain, beginning with seedlings that take five to eight years to mature. They’re harvested, transported, processed and shipped before a consumer picks them up at a store.
So, I bought a package of sliced mangoes and asked my colleagues to find out which farm these particular mangoes came from. Working with each stakeholder in the supply chain, they identified the farm in a mere six days, 18 hours and 26 minutes. And that was pretty good when the average traceback can take weeks.
Fast forward to the pilot using blockchain technology to trace mangoes from farms in Mexico to two stores in North America. For this test, each stakeholder in the supply chain, including farms, packing houses, transportation companies, importers/exporters, processing facilities, distribution centers, and stores, put data on the blockchain.
The blockchain then linked these blocks of data together to show the journey this mango took from farm to store. The result was a steep reduction in the time it took to trace mangoes—from 7 days to 2.2 seconds! That is what I have referred to as “food traceability @ the speed of thought.”
To give an example that’s more personal, when I sit down to enjoy one of my favorite desserts, tiramisu, I know that that I am looking at a multitude of ingredients, sourced from all over the world: cream from the U.S., chocolate from Belgium, vanilla from Madagascar, coffee beans from Colombia. My tiramisu may appear simple yet is made up of some of the world’s finest ingredients, and I care about the quality of every one.
Now imagine there’s a global recall of a certain brand of chocolate. As a consumer, I’d like to know that the chocolate in my tiramisu is not involved. As the food producer or retailer, I want this information too, and I need it immediately to minimize the impact on my business. New technologies and approaches, one of which is blockchain, have the potential to provide this level of traceability as part of a digitized food system.
Q: So, is FDA’s focus shifting away from FSMA?
No, we are not walking away from FSMA, but are building on it. A lot has changed since FSMA became law in January of 2011. And just like then, I believe we’re at another important inflection point as a society and as a profession. To me, FSMA is more than a Congressional mandate. It is a reflection of the dramatic changes happening in the food system during the years leading up to its passage, and it sets forth a vision of how regulators might continually modernize their approaches to meet new changes going forward. When FSMA was conceived and launched, it brought people to the table, both public and private partners. A New Era of Smarter Food Safety is doing the same. Now we plan to accelerate based on that foundation. How do we continue to modify and adapt? I foresee a more digital, data-driven, and transparent system that’s more precise and efficient.
Q: With the growth of e-commerce and the evolving last mile delivery, how will the changing marketplace be addressed in the New Era?
We’re looking broadly at how the food system is changing, from new foods to new business models that are emerging every day as consumers increasingly order their food online. For example, the growth of e-commerce and new ways to deliver food present many conveniences to consumers, but they could present new food safety challenges. How do we know, for example, that a food you ordered online comes from a firm that has adhered to good food safety practices and that the food will be maintained at a safe temperature as it makes its journey to your front door? Or how do we know that the container and packaging they’ve used are fit for this purpose?
And there is work to be done to help ensure the safety of foods sold at restaurants and other retail establishments, which are often at the center of foodborne illness outbreaks. How can we change longstanding behaviors that are known risk factors, such as sick employees being in contact with food?
The New Era is a broad approach to food safety, built on enhancing FSMA implementation, but also looking at other ways to tailor prevention to the realities of life so that you’re covered whether you’re buying your food, having it delivered, or eating out.
Q: You’ve spent a lot of your career focusing on food safety culture. What is that, and why do you feel it’s so important?
My interest in food safety cultures has a lot to do with my experiences in this work. And one of the things I’ve learned is that ensuring the safety of foods is more than simply having good procedures, policies, rules, or laws in place. At the end of the day, what’s written on paper is meaningless if people aren’t willing to put it into practice. It’s what people do – their behavior - that matters most.
That’s why culture is so important. You can never have enough inspectors to be everywhere. People must make the right decisions and display the right behaviors – at the right times and at the right places - even when no one is looking.
A food safety culture is how and what the employees in an organization think about food safety. It’s the food safety behaviors that they routinely practice and demonstrate. No food safety management system will be successful without a food safety culture in which employees understand what behaviors they must demonstrate and have the training and education they need. What is FDA’s role here? That’s what we’re looking at. We’ll do whatever we can to foster the development of strong food safety cultures on farms, in facilities, and even in the home, where safe food handling is important.
Q: What is the timeline for implementing the New Era approach?
Our plan is to publish a strategic blueprint early in 2020 that will outline the actions we’re planning. Right now, we have teams of FDA experts brainstorming ideas and considering how to make them a reality. We’ll also have the public meeting on October 21, 2019 to get input from a broad cross section of stakeholders, including the food industry, consumers, our regulatory partners, academia and others, on how they see this modern approach taking shape. People will also be able to submit written comments and data through the Federal Register when the meeting date is announced.
We plan to tap expertise both within and outside the boundaries of FDA and use all this information to build the roadmap. Dr. Sharpless has said, and I agree, it makes sense to establish the New Era at the start of a new decade.
Q: Why did you decide to come to FDA?
While I’m new to FDA, I’m not new to food safety. I’ve been doing this work for 30 plus years. At the Walt Disney Company and Walmart, my work involved helping to protect our guests and customers from contaminated food. Working at FDA is special because in a very real sense, all Americans are your customers. There’s a deep, scientific expertise here, and people are very committed to the agency’s public health mission. It’s a unique opportunity to serve the country in this manner.
Q: This is a new office – Office of Food Policy and Response. How do you see it taking shape?
As the title suggests, the priority for this office is food policy, with the emphasis on food safety and public health. This office will work with all branches of FDA involved in food safety, including the Centers for Food Safety and Applied Nutrition, the Center for Veterinary Medicine and the Office of Regulatory Affairs. We will be focused on prevention but will also respond to critical situations, such as outbreaks of foodborne illness. We’re consumer-centric. We advocate for the consumer in everything that we do.
Utlimately, whether you’re in the public or private sector, we’re all working for the same boss – the consumer. They’re counting on us to work together to keep their food safe.