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Good afternoon. I wish I could be with you in person today, but nevertheless, this truly feels like a gathering of friends and family to me. This is my third time speaking to you in my role as a Deputy Commissioner at FDA.
And I’m always glad to share a platform with my respected colleague and friend Sandy Eskin, who has worked so closely with FDA to protect consumers from unsafe foods, first at Pew Charitable Trusts and now at the U.S. Department of Agriculture.
In my pre-FDA life, I had the honor of being IAFP’s president.
So for me, this is exactly the right time to be with you, my partners in a common mission that we share to bend the curve of foodborne illness in this country and around the world - once and for all – so that consumers worldwide can live better lives.
We have a lot to cover today, but right at the outset I want you to know – very sincerely – how inspired I am by each and every one of you. During the COVID-19 pandemic, a public health crisis of historic proportions, your commitment to public health has never wavered. So, on behalf of FDA and consumers worldwide, I want to say THANK YOU.
The pandemic shaped our work, but it didn’t stop it. In contrast, as you will see when I give an update on our progress on the New Era of Smarter Food Safety, it has been re-energized, validated and re-focused.
FSMA – A Decade Later
I should also note at the start that this year marks a 10-year anniversary for the FDA Food Safety Modernization Act (FSMA), which was signed into law in January 2011. Congress’ mandate a decade ago is still true today. It’s not enough to respond to outbreaks of foodborne illness. We must prevent them from happening in the first place.
A decade later, what can we say has been accomplished? Because of FSMA, those who grow, produce, pack, hold, import and transport our food are now taking concrete steps every day to reduce the risk of contamination. The result is safer food in this country, whether that food is produced domestically or imported.
And importantly, and as a result of FSMA, there has been a bigger conversation about the importance of food safety over the past decade. This call to action has emanated from the halls of Congress to farms, food production facilities, corporate boardrooms, and consumers all over the world.
However, we recognize that there’s still work to be done and modernization isn’t something you can only do once a decade. It’s ongoing.
Modern Times Require Modern Approaches
In talking about our New Era of Smarter Food Safety initiative, I often say that we are in the midst of a food revolution. Think about it: Foods are being reformulated, new foods are being produced, there are new production methods being realized, and the food system is becoming more digitized.
But I believe that now we can declare that we are also in the midst of a food safety revolution. Let me repeat: We stand on the verge of a food safety revolution with new tools, new data streams, new technologies, and new approaches that will allow us to solve some of our remaining and most significant public health or food safety challenges.
I heard this quote recently and it really speaks to me: “The pace of change has never been this fast before, yet it will never be this slow again.”
On July 13th we marked one year since the release of the New Era of Smarter Food Safety blueprint that outlines our plans to leverage technologies, tools, and approaches to keep pace with the changing world around us and the evolving food system.
We’ve accomplished a lot of over the past year, despite COVID-19. I’d like to update you on both the progress we’ve made in strengthening the food safety net and the challenges we face, especially in our work to break the cycle of recurring outbreaks in certain foods.
The New Era of Smarter Food Safety
By the time the blueprint was released last year, it was clear that the time had come for the New Era of Smarter Food Safety. We learned during the pandemic that there is an accelerated need for certain goals in this blueprint, especially those involving food supply chain continuity and resiliency, modernized inspectional approaches, and the safety of foods ordered by consumers online.
We also saw how the New Era of Smarter Food Safety initiative advances FDA’s commitment to modernize how we utilize existing volumes of big data, as well as data from news sources to enhance inspections with a strengthened, data-driven, risk-based approach.
That we have been able to move forward with a plan launched in the heart of the pandemic speaks to the dedication of FDA staff and our regulatory partners at all levels of government, in this country and other nations.
It also speaks to the food industry’s commitment to protecting consumers. We have seen an impressive level of engagement by organizations representing farmers, manufacturers, retailers, technology companies, and other stakeholders.
Enhanced Food Traceability
A priority in both FSMA and the New Era of Smarter Food Safety is advancing food traceability to rapidly identify where contaminated foods were grown or produced and speed recalls when necessary. The first step toward this goal was accomplished when, in September 2020, the FDA published the FSMA-mandated Proposed Food Traceability Rule and a proposed list of foods for which the rule’s additional recordkeeping requirements would apply.
The proposed rule lays out key data elements and critical tracking events for enhanced traceability of these listed foods. We held three public meetings and anticipate issuing a final version of the rule in late 2022.
We learned during the pandemic that enhanced food system traceability might enable greater transparency that might help anticipate disruptions in the food supply chain and possibly avoid the kind of food waste we saw in the early months of the pandemic.
Our ultimate goal, as stated in the New Era of Smarter Food Safety blueprint, is end-to-end traceability throughout the food system, and we are taking steps to help ensure that tracing solutions are cost effective for food operations of all sizes.
In June, the FDA launched the New Era of Smarter Food Safety Low or No-Cost Tech-Enabled Traceability Challenge. Through July 30, the agency is calling for the submission of food traceability solutions that utilize economic models that are affordable for even the smallest producers and can scale to some of the largest firms – all with an eye toward encouraging widespread adoption.
And let me close with this, I know there are some who think traceability is a reactive concept. And while that comment may be well intentioned, I think it misses the mark. Better traceability is a game-changer for prevention, like pulsed-field gel electrophoresis and now whole genome sequencing (WGS) have been (neither one of them preventive tools).
With WGS, we’re increasingly finding needles in the haystack or turning the invisible visible by identifying clusters of illnesses. Think about it. While we can find the needles, we often can’t find the haystacks. This has to change in the 21st century. And it will.
WGS + realtime traceability = a game changer for food safety.
Strengthening Predictive Analytics
The New Era of Smarter Food Safety blueprint calls for data analysis to strengthen predictive capabilities and make more informed risk management decisions. Artificial intelligence is an important predictive tool and one we are using in a pilot that leverages AI, specifically machine learning, to strengthen our ability to predict which shipments of imported foods pose the greatest risk of violation.
Early findings focused on imported seafood indicate that this tool could significantly increase our ability to know which of millions of shipments to examine because they are more likely to have violative products.
The second phase of this pilot was launched in February, applying the AI model to field conditions. We hope to use this information to better target import review resources. And the agency is looking to apply lessons learned from the AI seafood pilot to scale the capabilities for other food and medical imports.
And while our focus will always be to help industry stay focused on prevention, the New Era blueprint also calls for an exploration of alternative ways for the agency to conduct its compliance oversight obligations.
Let me be clear, the 20th century is described as the Industrial Age. The 21st Century is and will be described as the Digital Age. To me, better compliance oversight (I would even say better food safety) begins and ends with better data.
Our plan to modernize inspections was put into action out of necessity during the pandemic when routine surveillance inspections were temporarily suspended last year before being resumed in July 2020.
In April 2020, we began remote inspections of importers subject to the Foreign Supplier Verification Programs requirements. The FSVP rule established by FSMA allows the FDA to request records electronically from importers to help ensure that their foreign food suppliers are meeting U.S. safety standards. By doing this, we have conducted a record number of FSVP inspections since March 2020 – almost 1,900.
But inspection modernization involves so much more than adding new tools tour toolbox. The heart of the matter is that we plan to further leverage new and emerging technologies and data-driven, predictive analytical approaches to strengthen our compliance oversight work.
The goal is not to do fewer inspections or less compliance oversight work. In contrast, the goal is to have greater insights and predictive capabilities so we can do the right work, at the right time, and when it’s needed to further strengthen safeguards for consumers.
This will be an exciting journey and, as usual, we will invite industry and stakeholders to have a seat at the table to so we can modernize together.
Turning Attention to E-Commerce
The way food gets to your home has evolved from around the corner to around the world, with an ever-changing last mile. Once again, a New Era focus to address potential food safety vulnerabilities for foods ordered online and delivered directly to the consumer has been accelerated by the pandemic because of the boom in online ordering.
One study reported that food retailers saw online sales jump more than 300 percent in the first several months of the pandemic. We are actively planning, along with state regulators, a public summit for later this year in which we will seek a greater understanding of direct-to-consumer business models and explore the best ways to keep these foods safe for consumers. Be on the lookout for the save-the-date notice very soon and I hope you can join us.
A New Perspective on Food Safety Culture
Now, very briefly, a few words on a topic that’s near and dear to me. We gained a new perspective during the pandemic on the importance of strong food safety cultures around the world.
At a time when regulatory officials were limited in their ability to conduct compliance oversight inspections, it was really up to food producers to ensure they were producing safe food every day, not because the inspector was coming but rather because they know food safety is the right thing to do and they care about their customers.
But embracing a food safety culture also means keeping food workers safe, a priority that has become clear during the pandemic. And with more people cooking at home when restaurants temporarily closed and consumers sheltered in place, we recognized that a food safety culture must start on the farm, but end in the home, so we responded to the need to support consumers with information on best food safety practices in their kitchen.
A big part of the New Era plan on culture in the short term is to promote food safety culture throughout the entire food system and throughout the agency itself. Our goals this year include work that is already underway to develop and launch internal training and education for FDA inspectional staff to introduce them to behavioral science and organizational culture principles that make-up food safety culture. We also plan to evaluate the feasibility of offering this training to state regulatory inspectors.
And lastly, it’s good to see Food Safety Culture becoming a legitimate subset of the profession – and not just a tagline or slogan -- all over the world. For example, the European Commission included food safety culture in an amendment of its hygiene legislation. And regulatory bodies in nations around the world are also focused on food safety culture.
Bending the Curve of Foodborne Illness
As I near the close of my talk, I’d like to come back to my title and ask you a question: Are we winning the battle against foodborne diseases? Because everything I’ve just mentioned and everything that we’re doing is to win the battle as measured objectively, right?
We know that statistics on the incidence of foodborne disease have stayed fairy flat over the past couple of decades and, in some cases, we’ve seen increases.
But I believe we can, working together, Bend the Curve of Foodborne Illnesses this decade.
As an example, let me the progress we’re making in our fight to break the cycle of outbreaks tied to leafy greens. In April, we released the report on our investigation into the Fall 2020 outbreak of E. coli O157:H7 illnesses linked to leafy greens grown in the California Central Coast.
Stakeholders familiar with this issue recognized the importance of the language we used. For the first time, we called a recurring E. coli strain O157:H7 a “reasonably foreseeable hazard” and identified the presence of livestock as a recurring safety issue on adjacent lands.
We are asking that all growers consider how the land adjacent to their fields is used, especially as it relates to the presence of livestock, and to execute appropriate risk assessments and mitigation strategies. And we are recommending that the agriculture community in the California Central Coast region work to identify where the reoccurring strain of E. coli O157:H7 is persisting and the likely routes of contamination.
We have updated the Leafy Greens Action Plan we released last year to renew the emphasis on actions to help prevent contamination from adjacent land use. Again, together, we MUST break the cycle of reoccurring outbreaks linked to leafy greens.
Revisiting Agricultural Water Standards
Another significant body of work that I believe will be a game-changer for food safety is work FDA is doing to issue a new, proposed Agricultural Water Standard under the Produce Safety Rule. I think we all know of the importance of the water link to all types of foods, whether its seafood, animal livestock production, and certainly produce.
Some of you will recall that the original Ag Water Standard compliance date was originally extended. But rather than simply extending the compliance date, FDA took another in-depth review at the original ag water quality proposal and we’ve revised it to ensure it’s strong enough to protect public health but practical enough to be effective on farms of all size and type.
We are committed to using the best science available to help minimize the risk that produce can become contaminated, including lessons learned from outbreak investigations. We expect the new, proposed ag water standard will be released within the next couple of months. And we look forward to receiving your feedback, once it’s public.
Working to Prevent Cyclospora Infections
Lastly, we’ve renewed our commitment to break the cycle of outbreaks caused by the parasite Cyclospora. Earlier this month, FDA released the Cyclospora Prevention, Response and Research Action Plan. Modeled after our Leafy Greens Shiga toxin-producing E. coli (STEC) Action Plan, the plan focuses on improving prevention, enhancing response activities and filling knowledge gaps to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.
The number of reported cases has been rising in recent years, in part because of better diagnostic and detection methods. According to the Centers for Disease Control and Prevention, there have been about 6,000 domestically acquired cases of Cyclospora infections over the last three years.
Despite improved detection methods, FDA and CDC continue to collaborate to develop a validated method for comparing human illness with food or environmental samples, in order to identify and respond to outbreaks more quickly.
We are currently investigating an outbreak of infections caused by the parasite Cyclospora that has made dozens of people sick. These illnesses often increase starting in May each year, and CDC will actively monitor these illnesses through September.
Rising case numbers and the emergence of Cyclospora contamination in domestically grown produce prompted the FDA to create the Cyclospora Task Force in 2019. The task force is comprised of multidisciplinary experts across the FDA and CDC, with the goal of reducing the public health burden of foodborne illness caused by Cyclospora in produce.
Our action plan underscores the importance of collaboration across industry, academia, state, federal and foreign government partners, and other stakeholders to reduce the risks and public health burden caused by foodborne Cyclospora. We’ll continue updating this plan as actions are completed and new actions are identified.
The Key is Working Together
In closing, I want to thank each one of you, as well as IAFP, for all that you’re doing to advance food safety, so that consumers can live better lives. Your work makes a difference. I hope you can see that we’re making progress and we’re doing work that’s never been done before.
But food safety requires collaboration. That’s never been truer than it is today. It’s a shared responsibility and we’ve all got a stake in this. And working together, I’m convinced, we WILL bend the curve of foodborne illness in this country, using the right technology, the best data, and the most consistent oversight.
Consumers deserve no less. Thank you.