- Speech by
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
Good afternoon. I want to thank NASDA for the invitation to join you today. It is a pleasure to be with you and to join the distinguished speakers in this session of your conference.
As the “junior” member of this group, I appreciate this chance to introduce myself to you and have the opportunity to engage in a discussion of some of the key issues about which we share an interest.
I’d like to start with the 3 priorities that we, at FDA, have established for the upcoming year – 1) unleashing data, 2) empowering the America Consumer, and 3) increasing choice and competition through innovation. All of these priorities are relevant in the area of food safety.
As you know we are in an unprecedented time for the development and application of scientific tools and new methods for using data to advance food safety.
I come to the job of Commissioner from a background in medicine -- as a researcher, cancer physician, and someone who has led medical research institutions.
What some might see as missing from my experience is a specific focus on food policy. So, let me begin by assuring you of my commitment to health and safety of the American people and this is of particularly important in the safety and security of our food supply.
I also realize how a strong partnership between FDA and NASDA members is so critical to these efforts.
This job presents many important areas for focus, but I am particularly enthusiastic about the chance to explore two of them – one being the world of foods and food safety. (The other one, which I’ll mention briefly – involves the work we do with veterinarians and pets. I am a big dog lover and proud pet owner.)
There is a good deal of overlap between medical science and food science. Most significantly, perhaps, in both areas we are the beneficiaries of unprecedented scientific advances that offer us significant opportunities to make the lives of American consumers … and patients … safer and healthier.
To cite just one example, consider our ever-increasing understanding of genetic analysis and in particular genome wide screening. Advances in this area have changed the way we look at many diseases, and today that offers us enormous potential for the development of new treatments and cures for many diseases.
But it also informs and improves our work in other areas, for example, giving us unprecedented ability to track and trace food outbreaks to their source.
The application of new technologies that change how we do research -- combined with the development and more effective use of new sources of data – are central to the work we’re doing at the FDA to modernize food safety and accelerate our responses to crises.
Indeed, one underlying principle is at the core of this work – the FDA’s science-based focus and the understanding that the agency’s decisions must be based on good data and sound science.
So, when I found out I would have this opportunity to speak with you today, I was pleased, because I knew we shared interest in some key issues and approaches.
In my relatively brief time at FDA and as I mentioned already, I’ve learned that the partnership we have with the states and NASDA is a valuable and productive one.
State agriculture agencies and NASDA are our partners in all aspects of our mission to protect consumers from contaminated foods, including produce, whether we’re implementing the Produce Safety Rule, educating growers, conducting inspections of produce farms, or responding to outbreaks of foodborne illness.
I’ve discussed with Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, the tremendous progress NASDA and FDA have made working together over the last decade or so. And we’ve also talked about some of the challenges we still face.
I want to assure you that we are committed to working together with you to overcome these challenges as they arise. We will do everything we can to build on our existing collaboration.
In looking at some of the challenges we face, I thought I would start with a topic I know is a great concern to all of us -- the importance of ensuring the safety of leafy greens.
Clearly, the leafy green outbreaks over the last several years underscore that we have more to do to ensure the safety of this food that so many Americans rely on as an important part of a nutritious diet.
As you know, FDA has been working with the produce industry and with you, our state counterparts, to respond to outbreaks of foodborne illness tied to the consumption of leafy greens.
We’re all concerned and frustrated by the recurring outbreaks of Shiga-toxin producing E. coli (STEC) infections tied to romaine lettuce and heartbroken by the stories of victims whose lives have been shattered.
We continue to support states taking the lead with routine (non-sprout) inspections of produce farms. As we finish our first year of routine produce inspections, our focus remains one of helping growers achieve compliance. Nevertheless, when necessary, we will work together to ensure prompt actions are taken to protect the public.
Moreover, when outbreaks occur, we must work together -- with all hands on deck -- to determine what went wrong and how to prevent them from happening in the future.
We are committed to doing more to prevent future outbreaks. For some commodities with which we’ve seen repeated outbreaks, we know that we need to change our approach. Past efforts clearly haven’t been enough to prevent additional outbreaks.
I am pleased to say that we are on the verge of releasing our Leafy Greens STEC Action Plan. This plan will outline specific steps we’re already taking, as well as important new actions that we’ll add this year to address this public health hazard from STEC. Many of the actions highlighted in this plan are the result of discussions with NASDA leadership and agriculture departments in various states.
Though we’ll release the full details of the plan soon, today I wanted to briefly outline the focus and give you some examples of how it will affect our efforts is in three areas: prevention, response and knowledge gaps.
First … prevention: We will continue our focused sampling assignment of romaine lettuce grown in the Central Coast, Central Valley, and Imperial Valley in California and in Yuma, Arizona for pathogenic E.coli and Salmonella. And we are taking multiple steps to address the safety of agricultural water.
Second … response: We will soon publish an investigational report of traceback and sampling activities conducted in the Salinas Valley growing region of California in the wake of three outbreaks last fall of E. coli O157:H7 associated with romaine lettuce or leafy greens.
I have asked Deputy Commissioner Yiannas and Director Susan Mayne, of our Center for Food Safety and Applied Nutrition, as well as Acting Associate Commissioner Judith McMeekin from the Office of Regulatory Affairs to expedite these reports.
We want to ensure prompt sharing of our investigational findings with you and the public as we work to prevent future outbreaks and re-evaluate how we are conducting outbreak investigations. Our goal is to ensure that we are doing all that we can in the most effective ways possible.
Third … addressing knowledge gaps: It is clear there is much we still don’t know about STECs in the produce environment -- where they live, how long they survive, as well as other questions.
Our goal is to work with growers and states to conduct long term studies in California and Arizona. This will help us better understand where the pathogens live in the produce environment and how we can place additional hurdles to prevent leafy greens from being contaminated.
We will also engage in a retrospective analysis of past outbreaks, mining data and conducting a risk assessment for contributing factors.
There’s much more in this action plan that I look forward to sharing with you in the very near future. It will play an important part in our efforts to get to the bottom of this frustrating situation and stop these recurring outbreaks once and for all.
You have my promise that we will do everything we can to this end. We owe it to the American consumer.
There are several ways we are combating the challenge of outbreaks, including those linked to leafy greens, that will also help us improve prevention of, and speed response to, other foodborne illnesses.
For instance, the work we’re doing to implement the Food Safety Modernization Act (what we all know as FSMA), is providing us with important new tools in this regard. FDA also is planning to release a blueprint for a New Era of Smarter Food Safety.
I’ll start with a brief discussion of FSMA, the landmark law that is a centerpiece of our work to help ensure food safety and prevent foodborne illness.
I know how hard you’ve worked to prepare the nation’s farmers to comply with the Produce Safety Rule under FSMA. The On-Farm Readiness Reviews alone continue to be an invaluable resource in helping farms assess how ready they are to meet the rule’s requirements.
As we roll out routine inspections to small farms (other than sprouts operations) this year, we look forward to continuing to work with our state partners and with NASDA. We also continue to recognize the extraordinary importance of education and technical assistance for smaller farms.
For our part, we are making progress in addressing some of the challenges we’ve encountered in our implementation of the produce rule, most notably involving the agricultural water standards.
We’ve also taken steps to honor our commitment to parity in oversight between domestic and imported foods. FDA began inspections of importers of produce under the Foreign Supplier Verification Programs in FY 2020 to ensure that they are verifying that their suppliers are complying with the food safety standards established by FSMA. I look forward to working with you as we implement and build on the framework created through FSMA as methods of food production and delivery evolve to meet the needs of the modern consumer.
New Era of Smarter Food Safety
I mentioned the New Era of Smarter Food Safety. We are very excited about the promise of this initiative. And as we move into this “new era,” our partnership with NASDA will be more important than ever.
That’s because the New Era plan incorporates the use of cutting-edge technologies that are already being used in society and business sectors, including blockchain technology, sensor technology, the Internet of Things, and Artificial Intelligence.
Each of these are examples of something I mentioned earlier – that we are living in a time of unsurpassed technological innovations, and we must use them in ways that empower consumers and enable farmers.
I will soon be announcing the publication of the New Era of Smarter Food Safety Blueprint. This will discuss measures that FDA and others may take to make this vision a reality.
What I can say right now is that one of the core elements of the New Era initiative is to tap into new technologies and integrate data streams to trace the origin of a contaminated food to its source in minutes, or even seconds. The technology already exists to do this.
This traceability component takes on a heightened importance in the face of recent outbreaks. That’s because our ability to rapidly trace back to the source of a contaminated food has lagged, in part, because of the lack of modern traceability capabilities.
Another core element of this plan is to expand how FDA mines data and uses predictive analytics to shape preventive measures.
As I noted earlier, one of the most important resources for our work lies in the power of data. We must do everything we can to attain more and better data for the work we’re doing, and to be more creative and thorough in our analysis of it.
The New Era is also about ensuring that we keep pace with new business models that produce and deliver foods in innovative ways, while working with traditional food retailers to protect from contamination the foods they serve.
I want to mention one more aspect of the New Era of Food Safety Blueprint that addresses an essential component of our work. This is the element of positively influencing behaviors on farms, in facilities, and within government itself to create a culture of food safety in which we each embrace our responsibility to help keep foods safe.
As I hope you can sense, we are very excited about the promise of The New Era of Smarter Food Safety. It’s about using innovative new technology. But it’s not just about technology. It’s about creating and putting in place more effective approaches and processes. It’s a new era for a new decade.
We look forward to sharing the blueprint with you and working with you to implement it.
Our collaboration with states is central to the success of the New Era – and to everything we do. It requires creating better processes for collaboration with states across a range of activities, from work planning, to training, to emergency response coordination.
Before I close, I’d like to touch on one other subject I know is of concern to you and the American people -- the regulation of CBD products.
At the FDA, we recognize that there is significant public interest in CBD. It’s also an area of particular attention for me. We want to empower the American consumer with accurate information about CBD and the role that FDA plays.
That’s because even before I came to the FDA, I saw the many CBD products that are out there and making claims that the products provide significant health benefits.
I’m also aware that many Americans are confused about whether these products are safe or whether they are even regulated by FDA.
We know that many Americans, farmers, industry, and states (among many others) have a strong interest in the path we ultimately take in this regard. In fact, my office has heard directly from many of you in this room on this challenging issue.
Over the last year, a priority of ours has been the evaluation of potential regulatory pathways, outside of the existing drug pathway, that would allow various types of CBD products to be lawfully marketed.
As we consider these issues, we will remain focused on the many unanswered questions concerning the safety of CBD in unapproved medical products, consumer products, and foods.
For instance, there’s still much we don’t know about the effects of sustained, long-term exposure to these products.
I can assure you that FDA will move forward carefully and deliberately as we determine the appropriate path to take.
It’s the approach that goes back to that core principle I mentioned earlier – our reliance on the best available science. Our decisions will be informed by a review of all the relevant research and data.
And our conclusions will address the needs and access of consumers in a way that ensures the protection of public health while maintaining incentives for cannabis drug development.
As we move forward in this area, I know that all of you will continue to play an important role in this process.
For many years, the FDA and NASDA have had good, strong and open channels of communication. We welcome feedback on how we can make this partnership even stronger in the future.
I am committed to ensuring the vibrancy and productivity of this partnership and to working closely with all our stakeholders, including our state and federal regulatory partners who are here today, as well as with industry and consumers.
I know there is a strong desire for continuing to strengthen communications between us, especially regarding contamination events and sampling assignments.
A strong, transparent, and ongoing collaboration benefits all of us – including the American consumer.
Deputy Commissioner Yiannas will continue to be the point person on food safety issues, working closely with both Dr. Mayne and Dr. McMeekin. I will be working closely with this very capable team on the many important food safety efforts within FDA.
I want to thank you again for inviting me to be here today. NASDA’s commitment to public health is robust and impressive. And I look forward to working with all of you to ensure that the food supply remains safe for all Americans.