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Good morning. This is my second time speaking to you in my role as a Deputy Commissioner at FDA, although our history together far predates my time at this agency.
I once had the honor of being IAFP’s president and I’m delighted once again to be with you, my colleagues and friends in industry, academia and government from all over the world, working together in our common mission to keep consumers safe.
At last year’s IAFP meeting, I introduced you to this idea of a New Era of Smarter Food Safety. Since we last talked about it, a lot of progress has been made and a lot has changed, too.
In March, we were literally days away from releasing the New Era of Smarter Food Safety Blueprint when the pandemic hit and the agency’s focus had to turn, rightfully so, to our COVID response. However, while we were dealing with COVID we had staff working behind the scenes on New Era and in July our Commissioner Stephen Hahn unveiled our New Era of Smarter Food Safety blueprint.
And today I want to provide you with a brief update on how our plans have evolved, progress that we’re making, and how our plans have been shaped by the pandemic.
We’ve also experienced a few foodborne outbreaks this summer, one associated with peaches, another with red onions and we had an outbreak of Cyclospora illnesses linked to bagged salads. So I’m going to try to touch on the objectives we set out in our New Era blueprint, building on the protections established by the FDA Food Safety Modernization Act, that I believe will have a direct impact on our efforts to prevent foodborne disease and once and for all bend the curve of foodborne illness.
But first, I’d like to pause and acknowledge the role that each and every one of you has played in keeping your fellow Americans and consumers worldwide, for that matter, safe during this pandemic.
Early on in the pandemic we saw some outages of certain food SKUs and tremendous imbalances in the marketplace as traditional food service and institutional outlets had to close, resulting in too much food being in the wrong places. Food producers had to quickly adapt, as you know, to implement measures to protect their workforce from the spread of COVID-19 in the workplace. But through it all, our food supply has remained what I call amazingly resilient. Consumers can still go into their favorite supermarket and have access thousands of different food SKUs that are available.
I’ve heard it said that food security is national security. I believe that -- it’s important. The work that you’ve done to ensure that consumers have access to safe and available food during this crisis is impressive and commendable. And for that, I wanted at the outset to pause to salute you. Together, we will come through this crisis stronger and more resilient than ever.
Four Core Elements
There are four Core Elements of the New Era of Smarter Food Safety blueprint:
- Tech-enabled traceability
- Smarter Tools and Approaches for Prevention and Outbreak Response
- New Business Models and Retail Modernization and
- Food Safety Culture
I know many of you have heard me say that a lack of traceability is an Achilles heel in today’s modern food system.
Better traceability from farm to table in outbreak situations will help us identify food vehicles sooner and potentially shorten epidemic curves and thus, in this manner, it is a form of prevention – secondary prevention.
But more importantly, better food traceability will help us to get back to source quicker to conduct the types of root cause analyses that we need to understand how these outbreaks occurred in the first place from pathogens such as Salmonella, Shiga-toxin producing E. coli and other pathogens. And once we learn how these contaminations can occur we can prevent them. Tech-enabled end-to-end traceability coupled with whole genome sequencing is a game changer for food safety prevention.
We also learned during the pandemic that enhancing traceability could also help create the transparency that’s needed in a crisis to anticipate and help prevent supply chain disruptions in a public health emergency, such as the COVID-19 pandemic.
And it can help FDA and industry anticipate and help prevent the kind of market imbalances and food waste we’ve seen over the past few months.
Food Traceability Rule
The first step in our work is to harmonize the key data elements and critical tracking events, known as KDEs and CTEs, needed for enhanced traceability. And we’ve done just that by issuing the draft Food Traceability Rule that is mandated by FSMA and we announced on September 21st .
In the new proposed rule, which hopefully you’ve already reviewed, we’ve released a draft of the food traceability list for the foods that would require additional recordkeeping.
Note that I’m not calling this a high-risk foods list. I’m calling it a foods traceability list because the reality is that any food can present a risk if the right food safety practices are not followed.
And while the proposed rule is for select foods, it does lay a foundation for end-to-end traceability by creating a standardized approach to traceability recordkeeping, paving the way for industry to adopt, harmonize, and scale more digital traceability systems in the future.
We will be holding virtual public meetings, actually several of them, which I encourage you to join, to get stakeholder input on this proposed rule on November 6th , November 18th and December 2nd .
And the public comment period via the Federal Register is open until January 21, 2021. So let’s hear from you.
Smarter Tools & Approaches for Prevention
Next, let’s move to Smarter Tools and Approaches for Prevention and Outbreak Response.
At the heart of this core element is a call for the use of smarter tools, such as root cause analyses, to understand how a food became contaminated and prevent risk factors from reoccurring. This element also has a very strong focus on predictive analytics.
And we’re also looking to expand how FDA mines data to strengthen our predictive capabilities, using new tools such as artificial intelligence and machine learning, among other things.
Imported Seafood Pilot
For example, we’re conducting a pilot that will leverage artificial intelligence and machine learning to strengthen our ability to predict which shipments of imported foods pose the greatest risk of violation and use that information to better target import review resources.
- A proof of concept application of AI and machine learning models to 2 years’ worth of historical shipment data of seafood import products into the U.S. indicates we can expect very promising results that I’m pretty excited about.
- Imagine having a tool that improves by almost 300 percent our ability to know which of millions of shipping containers to examine because they’re more likely to have violative products. You see, we’re not talking about things that can’t be done; we’re already doing this. This type of approach would save time, and more importantly, would save lives, and that’s critical.
- And beyond imports, strengthening our predictive capabilities will be transformational for the agency, and for our profession. We believe we will be able to leverage such approaches to decide, for example, which facilities we prioritize for inspection, what foods are most likely to make people sick, and other risk prioritization questions that we and many of you have.
New Business Models and Retail Modernization
The third element is New Business Models and Retail Modernization.
Some of you have heard me say that we’re in the midst of a food revolution. We’ll see more changes in the food system in the next 10 years than we’ve seen in the past 30. New foods are being produced, new food production methods are being realized, and the food system is becoming increasingly digitized.
Online Grocery Shopping
Before the COVID-19 pandemic, research indicated that online grocery shopping would have a 20 percent share of consumer food spending within the next few years. But now one survey, in the midst of the pandemic, reports that 31 percent of U.S. households are already using online grocery services.
This evolving landscape accelerates the need for us to work together to establish the appropriate standard of care to establish the safety of foods from around the corner to around the world and address the ever-changing last mile.
And as I mentioned, we’re real serious about bending the curve of foodborne illness so we’re taking a fresh look at more traditional business models to ensure foods sold at restaurants and other retail establishments are as safe as they can be.
- When outbreaks are tied to a single food-preparation location, the CDC reports that oftentimes the most important nexus is restaurants and other retail food establishments. And these collectively contribute to the overall burden of foodborne disease.
- At the same time, FDA baseline surveys of out-of-compliance rates of the risk factors at retail establishments have not changed decade after decade, despite continual retail food inspection and training efforts.
Are there creative, new, and smarter approaches – beyond traditional retail inspections and training – that could result in higher rates of compliance and reduced food safety risk to consumers? Of course, and we’re starting to work on them.
Food Safety Culture
And last but not least, the New Era speaks to the establishment and support of food safety cultures on farms, in food facilities, and in homes. The importance of food safety culture, as you know, has been a mission for me for many, many years and a discussion for IAFP.
Why Food Safety Culture Matters
Think about some of the major catastrophic events that you’ve read about in the newspaper – and when society has asked the smartest men and women to investigate those incidents. What do they conclude? Do they conclude it was improper training, inadequate SOPs, operator error, or faulty design?
No, when it really matters most of these investigations result in an underlying root cause and it’s almost always stated that it was a culture that allowed these tragedies to happen.
Peanut Butter, Infant Formula, & Ice Cream
You see, I believe some outbreaks we have seen in our profession and we investigate have more to do with culture than they do with what we often report about them. For example, the PCA (Peanut Corporation of America) outbreak, in my opinion, had more to do with culture than the ability for Salmonella to survive in a low moisture food.
Or how about melamine in dairy powders? It’s not just the idea of chemistry or something being introduced to make a product look higher in protein content. It’s a culture that allowed that to happen. Or Listeria in ice cream, in a company that hadn’t had a negative experience with food safety failure in 108 years of experience. You can see where an organization might get a little bit complacent.
Food Safety = Behavior
What we say or what we write about food safety matters, but it’s not what matters most. It’s what we DO - our behaviors - that matters most. In fact, I like to say that simply put, food safety equals behavior.
We will not make dramatic improvements in reducing the burden of foodborne disease without doing more to influence what employees think about food safety and how they show a commitment to this goal.
And lastly, the pandemic has shined a light on other aspects of what it truly means to have a food safety culture.
- It’s about influencing the behaviors of the people who work on farms and in facilities, but it’s also about keeping those our employees and our colleagues safe when others are sick.
- It’s about educating consumers on the best food safety practices to apply in the home when we know that consumers are doing more cooking at home than ever before.
FDA wants to advance this idea of food safety culture as a legitimate subset of the science – and not just a slogan.
And our first step is to work with you stakeholders in a collaborative manner to better define food safety culture and what it means in particular in the context of regulatory oversight.
We will be identifying ways for industry to develop a strong food safety culture within existing regulatory requirements, and tools that companies can use to assess their own food safety culture.
Produce Safety Update
I’d like to segue here to advances we’ve made in helping to ensure the safety of fresh produce.
Leafy Greens Action Plan
Work has continued throughout the pandemic on the 2020 Leafy Greens STEC Action plan to help prevent recurring outbreaks of Shiga-toxin producing E. coli linked to the consumption of fresh leafy greens. This initiative echoes many of the same themes you’ve heard as I’ve discussed the blueprint. And we’ve made progress, despite the challenges of these times.
- For example, in May we issued a report on the investigation into the contamination of romaine lettuce implicated in outbreaks of E. coli. The traceback and sampling in the Salinas Valley growing region of California suggest that a potential contributing factor in this, and other outbreaks, was the proximity of cattle to those produce fields.
Water Treatment Protocol
Another advance tied to this plan is an announcement we made in July that FDA and EPA have released a new protocol to aid in the development and registration of treatments for the control of microbial contaminants in preharvest agricultural water.
- EPA approved the protocol, developed by FDA scientists, that will assist companies in registering their products if they can demonstrate that they will be safe and effective against pathogens that might be in water and are hazardous to public health.
- Once available, EPA-registered water treatments will be yet another valuable tool to help farmers address contamination issues in their water sources and protect consumers from foodborne illness.
In addition, and very importantly, we intend to release a proposed rule in the coming months to revise certain agricultural water requirements in the Produce Safety Rule under FSMA. We’re going to ensure that it’s practical enough to address the implementation challenges that we heard while protecting public health.
I also want to share a development that highlights some the great work that our scientists have done over the past few years to enhance our ability to investigate outbreaks related to Cyclospora. This past year, many of you have heard there was an outbreak of Cyclospora illnesses tied to the consumption of bagged salads. This outbreak made 700 consumers sick in 14 states.
In August, we were able to report the scientific progress we’ve made in using a new method developed and validated by the FDA staff to sample and detect Cyclospora in agricultural water for the first time in a field investigation.
This method was used in our investigation and I think it’s going to be instrumental in our efforts to better understand the dispersion of this parasite in the environment, and it will help prevent future outbreaks. Environmental sampling detected the presence of Cyclospora in the surface water of a canal near a farm which had been identified in traceback.
FDA also pioneered a new method to test for Cyclospora in produce. This method was used in 2018 to confirm the presence of the parasite in a salad mix product tied to an outbreak that sickened hundreds of people. These scientific tools are going to be invaluable in our battle for prevention.
Lastly, I’d like to touch on the importance of collaboration and partnerships. We all know that food safety requires collaboration, both in the private sector and in the public sector. A classic example is the work we have done with the papaya industry, among others.
In an August of last year, I sent a letter to all sectors of the papaya industry with a call to action to break the cycle of recurring outbreaks of Salmonella infections associated with imported papayas. This pattern of eight outbreaks since 2011 tied to consumption of imported papaya accounted for almost 500 reported cases of illness, more than 100 hospitalizations and two deaths. We knew we could do better.
And since that call to action our regulatory partners in Mexico, the largest supplier of papayas to U.S. customers, and the produce industry and others have really stepped up to do important work to develop food safety best practices for the papaya industry to follow.
And I’m very proud to report that this year we have not experienced a major outbreak of Salmonella in papaya. That’s partnership at work! And I call that the anonymity of prevention. No headline, but I don’t think that happens by chance.
This is just part of the work we’re doing as part of an agreement with our regulatory counterparts in Mexico to strengthen our food safety partnership for the benefit of consumers in both our countries.
So I hope you can see that there is some real progress being made despite the current challenges we’ve all been facing. The FDA is doing work that it has never done before.
In closing, I’d like to pivot back to the New Era of Smarter Food Safety. Even though the blueprint is out, these are early days in an initiative that will span the next decade.
We will work with a broad expanse of stakeholders in industry, academia, trade associations, and consumer groups, as well as our regulatory partners, and groups that we had not traditionally engaged with before, such as technology companies.
The role that each and every one of you play in protecting the food supply makes you essential. Rest assured, you will always have a seat at this table.
And I look forward to working with you as we enter this New Era of Smarter Food Safety together. Thank you.