- Speech by
(Remarks as prepared for delivery)
IAFP members, respected colleagues, and friends, it’s so great to be with you in person. As a former president of IAFP, attending an annual meeting always feels like a bit of a food safety family reunion, as I get to reconnect with so many of the food safety professionals worldwide who I’ve had the opportunity to learn from and collaborate with for more than three decades.
And while I’ve presented at IAFP meetings many times, this is my fourth time as Deputy Commissioner, this time it feels different. Maybe it’s because of the moment.
For our brief time together, there’s much I could say. I could give an update on our current activities. Instead of trying to run through an update list, though, I’d like to do something that I think is equally important. I’d like to reflect on what we’ve been through, together, and more importantly, where we’re headed.
These are challenging times in our nation and in the world as the global food system faces unprecedented headwinds. And these are challenging times as we find ourselves re-evaluating how to best achieve our mission to ensure consumers have access to safe and available food.
The sheer scope and scale of the global food system is daunting. On top of that, we’re facing a multitude of new pressures, whether it’s labor shortages, supply chain bottlenecks, effects of climate change, regional conflicts, or inflationary headwinds.
New Era Dawning
But challenges give birth to opportunity. They shape a vision of what the future could be, looking beyond what we currently do know to what we will know.
The greatest visionaries throughout history – be they world leaders, architects, or scientists – all forged a path to a future they could only imagine, a path that led to innovations in technology and thought that became a reality for those who followed.
Today, I’m asking YOU to do the same.
I want you to imagine a future in which all the information we need about food or how it is being produced is available to us at the speed of thought.
I’m asking you to imagine a future in which the global food system is so transparent and data-informed that we can immediately trace a food’s journey to its origin in seconds – not days. And we’ll know more than where it came from; we’ll know exactly how it was produced and handled at each step of the way - and will also know the impact that any disruptions related to that food will have on the food system and, ultimately, its safety and availability to consumers.
I’m asking you to envision a future in which the generations who follow us will know that the food system and the food it produces is safe and sustainable because the steps we take today will make that a reality for them tomorrow.
I know it feels like we’ve come so far in food production and food safety, and we have. Yet both will be dramatically transformed in the years ahead.
Changing Food System
Food systems have been evolving since the dawn of civilization and the emergence of agriculture to feed not just a family, but a village, as humans started to raise plants and animals around water.
Fast forward to the industrial farming revolution of the early 20th century and food production became further organized to feed larger cities and support economies. Over those centuries, trading routes evolved from linear paths to today’s complex, distributed, and interdependent networks.
Through the years, science and technology have always been critical drivers of that change. And today, we’re in the midst of a food revolution. Foods are being reformulated, new foods are being produced, new food production and delivery methods are being realized, and food is increasingly becoming digitized.
And food has gone from around the corner to around the world in both production and our shopping practices. In fact, the world is essentially the grocery store, with retail stores evolving from a limited number of SKUs to tens of thousands of SKUs, with e-commerce and omni-channel, where you can go online and order what you want, anywhere, and anytime. The endless shelf, not limited by the size of a store or distribution center.
We are at an inflection point as industry employs new technologies to meet consumer expectations for convenience, healthier, safer, more transparent, sustainable, and affordable food. We are also at an inflection point in our work to help ensure that innovations and efficiencies don’t come at a cost to public health. To create this safer, future food system, we’re going to have to think and work differently.
Evolution of Food Safety
Our approach to food safety has also been evolving over the course of centuries. Concerns about food safety led to the founding of the U.S. Department of Agriculture by Abraham Lincoln in 1862. Within the new USDA was the Division of Chemistry, which would evolve years later into the FDA. The Federal Food, Drug, and Cosmetics Act of 1938 gave FDA the authority to oversee the safety of food, drugs, medical devices, and cosmetics.
The landmark legislation that is our guiding light today is the 2011 FDA Food Safety Modernization Act, in which Congress shifted FDA’s focus to the prevention of foodborne illness by establishing science and risk-based standards for domestic and imported foods.
And today, we’re building on FSMA through the New Era of Smarter Food Safety Blueprint that FDA announced in 2020.
Now you might be asking yourself, why is this New Era needed? While there is no doubt that we’ve made a lot of progress in our battles against foodborne illnesses over centuries, the battles we face today are different.
In 2022, can we say that we are currently winning the battle against foodborne disease? Are we truly bending the curve of foodborne illness in this country? Reporting by the Centers for Disease Control and Prevention indicates that our recent progress has been flat, without significant declines in the incidence of many foodborne pathogens for over two decades.
In other words, our progress is stalled. Improvements in detection are no doubt a factor, but we can’t use that as a crutch.
A Bridge to the Future
One of the ways we’re building a bridge towards that brighter future and bending that curve is through our New Era of Smarter Food Safety initiative. The New Era emphasizes the need to create safer, more digitized, and traceable food systems for the future. It also calls on the need to use new tools and approaches for prevention.
Using authorities granted by FSMA, and through New Era approaches, we’re doing just that. As an example, we anticipate finalizing in November the proposed Food Traceability Rule and the list of foods for which additional recordkeeping requirements apply. The approach we’re taking, emphasizing key data elements (KDEs), and critical tracking events (CTEs), is an initial and critical step to creating a universal language of food traceability that will ultimately lead to greater transparency.
To me, what we’re doing is the equivalent of pouring concrete for a national, hopefully global, interstate highway system of information tracking for food.
As yet another example, we’re exploring the use of artificial intelligence in import screening to strengthen our predictive capability to identify potentially violative products. Early results are very encouraging.
You can see that, in many ways, we have already started on this path to the future.
Data, Data Sharing, Digitalization, and New Ways of Collaborating
But we’re just scratching the surface. We, as professionals who have dedicated our careers to food safety, must see that the world of big data and digital transformation is sweeping across all industries and disciplines – and the field of food safety will be no exception.
Simply put, better food safety begins and ends with better data.
Increased, high-quality data, along with emerging information technologies and better sense making tools will help us convert data into better predictive, prescriptive, and preventive information. This in turn will allow us to target risk and apply our food safety resources in more effective ways.
Imagine a world in which we are using real-time data and computing tools to see patterns and trends that have gone unseen and turn it into predictive information, such as to understand how weather patterns in another part of the world in April could impact the safety of food consumed in August in our country.
Or imagine if we had mechanisms to share data amongst industry players that helps us identify root causes of contamination that we never understood before. What if FDA could use that data to collaborate with industry to trigger near real-time interventions when a risk factor appears, rather than using our current three and five-year high-risk and non-high risk inspectional cycles.
I can see a future in which FDA food safety experts – as well as industry professionals - are working together in a more multi-disciplinary way and with new tools – using their collective expertise to act rapidly to make our food supply safer.
But for this new future to become a reality, digitized data alone in one node of the food system is not enough. In an interdependent food system, data will have to be democratized so the entire food system gets smarter together and enhances how the different parts work together.
You see, I believe that in the 21st century, we have to redefine collaboration to include data sharing, both private to private, private to public, and public to public. A good example is the regulatory partnerships we’re exploring with other countries to leverage commodity-specific oversight systems, along with data and information to strengthen food safety before and at the port of entry.
I also know some data trusts are underway in the private sector, such as the Western Grower’s data sharing project on fresh leafy greens.
These are good starts, but there’s much more to do.
Let me share a real-world example to demonstrate that this future is already here, using work that we’ve done using our 21 Forward supply chain data and analytics platform.
This tool was originally created during COVID-19 to monitor in real-time the pandemic’s impact on FDA- regulated food facilities. It was born out of discussions I was having at the time with the Commissioner that included a recognition that the health of food industry workers is critical to the function of the food supply chain. Food supply chain continuity and worker safety and health are two sides of the same coin.
Thus, we developed, in record time, a platform that identifies – in spatial form - FDA regulated food locations by type, size, and food produced – along with COVID transmission modeling down to the county level. This data-driven approach and platform enabled us to help companies anticipate when COVID might be on the verge of impacting communities near their facilities and help them protect their workforce.
It also enabled us to provide information on the location and number of food workers to state agencies for vaccination planning. And it gave us a better understanding of what was happening across the country, such as raw material needs and transportation challenges.
When the infant formula crisis hit, we were able to build on 21 Forward to help support the data analysis needed for an all-of-government response to the nationwide shortages. Today, we have insights about infant formula availability, and distribution that we’ve never had before. This system is already paying dividends by providing insights that have facilitated private-public collaboration to help ensure parents and caregivers have access to safe, nutritious, and available infant formula.
But infant formula isn’t the only food commodity for which this type of data analysis and response scenario planning is needed. And supply chain resiliency isn't the only use-case that can benefit from this approach. My team is envisioning right now how these tools could be used in more traditional areas of FDA’s work, such inspection planning tied to emerging food safety concerns and outbreak response informed by market data.
Poised for a Quantum Leap
Now, you might have heard that FDA Commissioner Robert Califf has pledged a top-to-bottom review of the agency’s foods program, addressing fundamental questions about structure, function, funding, leadership, as well evaluating FDA’s inspectional activities.
I support this review.
Dr. Califf’s statement reflects a recognition that now is the time take note of what is needed to make a quantum leap, not incremental steps, so that FDA’s food program will be able to make decisions – and act on them -- based on the best information, in minutes or hours instead of days, weeks, and months.
Now is not the time for small steps, neither at FDA, nor in your own organization. Instead, now is a time to reimagine a better future using new tools and new approaches.
In closing, I’d like to leave you with this thought: This is our moment.
This is the moment when we can choose to invest in new and life-changing food safety approaches, such as emerging data and technology systems, genomics, new microbial interventions, automated monitoring, near real-time microbial detection methods, and more.
This is the moment when we can build the kind of systems that will help prevent a crisis, like many of the recent foodborne outbreaks reported around the world, or the recent infant formula incident in the U.S., so that incidents like these never happen again.
This is the moment when FDA and other food safety system leaders alike unite - not to simply imagine a better future, but to create it, together.
So here we stand. We have a choice. We can continue to take incremental steps. Or we can take a quantum leap forward.
You – each and every one of you – are the ones who can envision the future and support the actions we need to take today to get us there.
Imagine a world in which you can pick up a food package in a grocery store and you can trust it, because you know everything you need to know about it.
Imagine that – and leap.