Deep Dive Episode 263 – Food Safety: When Regulatory Jurisdictional Battles and Public Safety Collide
Food is a necessity for life. It should therefore surprise few that the federal government regulates the production and processing of food before it reaches our dinner tables. Labels indicating some meats are “USDA-Prime” or confirming that the product was inspected and approved as safe before delivery to the grocery store reflect this regulatory role.
While labels may make the regulation apparent, which part of the administrative state handles that regulation can be less clear. Two agencies: the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) — part of the Department of Health and Human Services — both have jurisdiction over the foods we consume. Which agency handles what is not always apparent. Recent illnesses and deaths involving baby formula and spinach — both under the FDA’s inspection jurisdiction — have emphasized that regulatory structure can have life-or-death consequences. This has led some on both sides of the aisle to suggest a revamp of how we handle food safety regulation. One group contends the FDA should take the lead (Food being literally in the name); a second argues the USDA should run point (agriculture being the first step to food production), and a third group argues creating a separate agency entirely would be the best solution. The FDA itself has proposed an internal reorganization to emphasize its food safety mandate.
This panel of FDA and USDA veterans whose service spanned multiple administrations will examine the questions (1) how safe is our food, (2) is a reorganization of the agencies that handle food safety necessary to achieve the maximum level of safety, and (3) how should such a reorganization look.
Although this transcript is largely accurate, in some cases it could be incomplete or inaccurate due to inaudible passages or transcription errors.
Chayila Kleist: Hello, and welcome to this Regulatory Transparency Project webinar call. Today, April 27, 2023, we’re excited to host a panel discussion entitled “Food Safety: When Regulatory Jurisdictional Battles and Public Safety Collide.” My name is Chayila Kleist, and I’m an Assistant Director of the Regulatory Transparency Project here at The Federalist Society.
Joining us today is a stellar panel of FDA and USDA experts who bring a range of views to this discussion. As always, please note that all expressions of opinion are those of the experts on today’s program, as The Federalist Society takes no position on particular legal or public policy issues.
Today, we’re pleased to have with us as our moderator Dr. Stephen Vaden, who currently serves as a judge in the United States Court of International Trade. Prior to joining the court in 2020, Judge Vaden served as General Counsel at the United States Department of Agriculture.
During his nearly four-year tenure as head of the Office of General Counsel, the department won two cases before the United States Supreme Court, relocated and reorganized agencies that combined the department in order to better serve rural America, engaged in substantial regulatory reform, developed new regulations to allow the legal sale of hemp and labeling of bioengineered products, and implemented the 2018 Farm Bill.
Judge Vaden also served as a member of the board of the Commodity Credit Corporation, a government corporation devoted to helping American agricultural producers. And in the private sector, Judge Vaden has worked for two law firms: Jones Day and Patton Boggs. At both, he served as appellate litigator and as part of the firm’s political law practices.
Now, in the interest of time, I’ve kept my introduction brief, but if you’d like to know more about any of our guests today, you can access their full bios at fedsoc.org. One last note before we get started. Throughout the panel, if you have any questions, please submit them via the Question and Answer feature so we will have access to them when we get to that portion of today’s webinar. With that, thank you all for being with us today. Judge Vaden, the floor is yours.
Hon. Stephen Vaden: Thank you so much, Chayila, for that kind introduction, and thank you to everyone for joining us today for what promises to be a very interesting and timely panel. Food, of course, is a necessity for life. It should, therefore, surprise no one that the federal government regulates the production and processing of food before it reaches our dinner tables.
Labels indicating some meats are USDA prime or confirming that the product was inspected and approved as safe before delivery to the grocery store reflect this federal regulatory role. However, while labels may make the regulation apparent, which part of the administrative state handles that regulation can be less clear.
Two agencies, the United States Department of Agriculture and the Food and Drug Administration—which itself is part of the Department of Health and Human Services—both have jurisdiction over the foods we consume. Recent illnesses and deaths involving baby formula and spinach, both under FDA’s inspection jurisdiction, have emphasized that regulatory structure can have life-or-death consequences.
This has led some on both sides of the aisle to suggest a revamp of how we handle food safety regulation. One group contends the FDA should take the lead, as food is literally in its name. A second argues that USDA would be better suited to run point, agriculture being the first step in food production, while a third group argues that a whole new agency should be created with the sole mission of policing food safety.
Recently, the FDA itself proposed an internal reorganization to emphasize its food safety mandate. This was after the issuance of a report by the nonprofit Reagan-Udall Foundation, which recommended a complete revamp of the way the Food and Drug Administration regulates food safety. In a nutshell, as you’ll hear from our speakers soon, the report thought that food was not a high enough priority for the FDA, and there were too many people who had a leadership role in it rather than one central point person.
To tell us more about the problems that are becoming apparent in our food safety regulatory scheme, we literally have the best panel that you could put together. I’m going to introduce them in the order in which they will speak. First, Frank Yiannas. He is a former Deputy Commissioner for Food Policy and Response, a position he first assumed in December of 2018. In that role, Mr. Yiannas served as an adviser to the FDA commissioner in the development and execution of policies related to food safety, including implementation of the Food Safety and Modernization Act, known as FSMA.
Before his time at FDA, Mr. Yiannis worked for Walmart and Walt Disney, both concerning with food safety. He is a microbiologist and received his BS in microbiology from the University of Central Florida. He also holds a master’s in public health degree from the University of South Florida.
Following Mr. Yiannas, we’ll hear from Dr. Mindy Brashears. Dr. Brashears was a colleague of mine when I was at USDA, where she served as the Undersecretary of Agriculture in Food Safety. She is currently the Associate Vice President of Research at Texas Tech University and also serves as a professor of food safety and public health, holding the Roth and Letch Family Endowed Chair for Food Safety.
Dr. Brashears also serves as the Director of the International Center for Food Industry Excellence at Texas Tech University. And our audience may be interested to know that she’s not all academic; she is also involved in three spin-off companies that have been founded based on the research she has done. Dr. Brashears holds a BS in food technology from Texas Tech and master’s and PhD degrees in food science from Oklahoma State University.
And finally, we will be joined by Dr. Stephen Ostroff. Dr. Ostroff retired from the Food and Drug Administration in early 2019. During his seven years at FDA, he served as Deputy Commissioner for Foods and Veterinary Medicine, where he oversaw the agency’s food and animal health activities, including responsibilities over food safety, nutrition, food labeling, and child nutrition.
Dr. Ostroff served twice as the FDA’s acting commissioner in both the Obama and Trump administrations. He also served as FDA’s chief scientist. Before joining the Food and Drug Administration, Dr. Ostroff worked at the Centers for Disease Control in Atlanta for more than 20 years on infectious disease surveillance and outbreak investigations, and he was also a member of the U.S. Public Health Service Commissioned Corps, attaining the rank of Assistant Surgeon General.
Dr. Ostroff received his undergraduate and medical degrees from the University of Pennsylvania, and he currently holds Adjunct Professor appointments at Penn State’s College of Medicine’s Department of Public Health Sciences and the University of Pittsburgh School of Public Health’s Department of Epidemiology. So, as you can see, we have quite the panel of experts today. And I will delay no longer. Mr. Yiannas, the floor is yours.
Frank Yiannas: Thank you, Judge, and good morning, everyone. It’s a pleasure to be with you. You know, as I thought about what we were going to talk about today, I was delighted that we would have a bigger conversation about food, food policy, and food safety in our nation. The reality is I don’t think there are too many topics that are more important than the one we’re talking about today, quite frankly: food.
You’ve already heard from the Judge that food is essential to human existence. And while we’re living in an increasingly polarized society, the reality is there’s one thing we all have in common, and that is food. We’ve all heard food security is national security.
For the brief time that I had an opening comments, I’m going to try to answer the three central questions that we’ve been asked to do: How safe is our food supply? Should we be worried about it? Is a reorganization of the agencies that oversee food safety in our nation necessary, and what should a reorganization look like? But if I may real quickly, I’m going to try to set a little bit of the stage or context before we dive into these questions.
The reality is that the food system has been changing since the beginning of civilization—we all know that—with the emergence of agriculture to not just feed a family but a village and larger societies as men and women started to domesticate plants and animals, mainly around water and villages.
If you fast forward to life as we most know it, in the 20th century, we had the industrial farming revolution able to produce more food than ever before to feed growing cities and support economies. The trading routes and paths of food have become increasingly complex from around the corner to around the world, and through all this time, science and technology and regulatory agencies have been central to how these advancements have been made.
Today, I like to say often that we’re in the midst of a food revolution, and I don’t think I’m exaggerating when I say that. As we speak, foods are being reformulated, new foods are being produced and achieved. And Mindy and I actually signed a memorandum of understanding on how we would regulate cell-cultured foods, so what would FDA do versus USDA. We know there are new production methods being realized and the food system is becoming increasingly digitized.
And so, fundamentally, what you’re going to hear from me is that I believe, in these modern times, we’re going to need more moderate approaches to how we oversee and regulate food. The paradigms and the structures and the processes that we’ve used in the past, in my view, are insufficient.
Food regulations have changed. I won’t go through the long history lesson there, but concerns about food safety led to the founding of the Department of Agriculture by one of my favorite presidents, Abraham Lincoln, in 1862. Within the USDA, there was the division of chemistry, which would, years later, evolve into what we now know as FDA. And we then got the Federal Food, Drug, and Cosmetic Act of 1938, which gave FDA authority to oversee the safety of foods, among other things.
Much of what the FDA, the agency I work for, does today in terms of our guiding light or principle to overseeing food safety is through the passage of the 2011 Food Safety Modernization Act. And the agency is now trying to build on modernization through something we call the new era of smarter food safety.
Let me get to the three questions that the Judge has asked that I answer. The first question is, is our food system safe enough or, stated differently, are we winning the battle against foodborne disease? And while there’s no doubt in my mind that we’ve won many battles over the past century or centuries against infectious diseases, the battles that we face today, quite frankly, are a little different.
Recently, FDA Commissioner Rob Califf published a Voices blog that stated the U.S. has one of the safest food supplies in the world. And while that’s true, I don’t think it’s a response you want to give to the parents, let’s say, of little Lucas Parker, a young little boy that traveled from Canada with his parents during the fall of 2018 to visit Disneyland and, hopefully, having the vacation experience of a lifetime. Him and his family made the mistake of eating a salad that contained Romaine lettuce that was contaminated with E. coli 157. Little Lucas today suffered very harmful effects of that infection. He can no longer walk, he can no longer write, he can no longer talk, and he no longer can see.
Tell that to the parents of young boy by the name of Ricus [sp], who, after six weeks of age, started becoming very ill and was diagnosed with bacterial meningitis, ultimately identified to have an infection due to Cronobacter sakazakii, a rare but infectious organism often associated with powdered infant formula. Unfortunately, little Ricus [sp] had to have 75% of his left brain removed. Tell his parents that we have the safest food supply in the world.
Now, the CDC gives us the big picture. They say 48 million Americans experience foodborne illness a year, 128,000 hospitalizations, 3000 die. But I want this audience to know that behind these numbers are real faces and real people, and I want everyone to know that these types of stories are absolutely preventable and that the industry and regulatory agencies can do more.
And if you look at more recent times, is our food safe? If you look at the most current trends of foodborne disease published by the Centers for Disease Control and Prevention, the scorekeeper, they’ll show you that the incidence per 100,000 population of specific pathogens that we’re concerned of, such as salmonella and campylobacter and listeria—you can go to their website—the incidents per 100,000 population has remained relatively flat for almost two decades, for almost 20 years.
Is our food system safe? Well, it’s as safe as most nation’s, but there’s more that we can do and we must do. The second question the Judge asked: Is a reorganization of the agencies necessary to oversee food safety? Let me begin by stating the obvious, having worked on both sides of the fence the public and private sector. The private sector has the primary responsibility for producing safe food, but having stated that, the public sector has an important role.
The oversight system in the United States is what I call a patchwork of federal, state, and local agencies. You’ll hear a little bit about the difference between the FDA and USDA. I like to say the FDA has a very important responsibility, overseeing about 80 percent of the nation’s food supply. The jurisdiction falls like this: The FDA regulates about 80 percent of the food supply. Think about those foods and food ingredients introduced and offered in interstate commerce other than meat, poultry, certain processed eggs, and catfish.
If you think about your favorite grocery store and you walk into it, if you walk in and you see all of the bulk displayed and all the pre-cut salad at the front, for safety reasons, regulated by FDA. If you walk down most of those aisles and you see all the dry packaged goods, cereals, baby food, you name it, most of that regulated by FDA. If you look at the milk products and the non-animal sources of milk, all of the yogurts, the proliferation that has happened there over the past few decades, all of that regulated by FDA.
And so it’s a pretty important responsibility, and we’ll talk about some of the differences. But within FDA itself, our food safety oversight system is very fragmented. We all know the important role the FDA plays; obviously, a large, decentralized institution that oversees regulation of about 20 percent of the products that are purchased in the U.S., ranging from tobacco, drugs, over-the-counter type products, dietary supplements, and foods, but how it regulates foods is also decentralized, and I think you’ll probably hear this from Stephen Ostroff.
Currently, it has four offices or centers that oversee food safety: the Office of Food Policy and Response within the commissioner’s office that I played a role in. You have the Center for Food Safety and Nutrition, a very important center that people are aware of that work with food. You have the Center for Veterinary Medicine. Congress told us animal and human food are important and you got to look at these things similarly. And the Office of Regulatory Affairs, the large field force that gets the lion’s share of FDA’s $1.4 billion.
And as you heard from the Judge, recent experiences have shown that this decentralized nature of the FDA hinders its ability to do its job well and protect public health. And I testified to that recently in front of an oversight hearing in Congress, that the fragmented, siloed nature prohibited and minimize the ability for information to get rapidly to the places that knew.
And even as someone who should have known what was happening on infant formula very quickly, I didn’t learn about the start of that incident until almost four months after it occurred, and it almost took the agency for months to respond, to show up to the formula plant that was making the infant formula product.
So is a reorganization needed? Certainly, within FDA, the answer is yes. But the last question is, how would you do it? And I’ll leave you with this because I think we’ll get to the heart of the matter, Judge, in the discussion. I’ve learned by working some pretty good brands—the Disney Company and Walmart—that the initial focus shouldn’t be reorganization; it should be strategy.
Vision and strategy always comes before structure, and then and only then can you put the structure in place. I love this quote. I don’t know if it’s really by Petronius, but it’s attributed Petronius, who said, “We tend to meet any situation by reorganizing and, what a wonderful method it can be for creating the illusion of progress.”
So I can tell you I’m a firm believer after 38 years, some in the public and some in the private sector, that I do think it’s time for FDA to create a single food structure and strategy, but I also think it’s time for the nation. I’m a proponent of a single food safety agency.
Some of the principles, not necessarily the structure, is that it ought to be a cabinet-level position. Some of the principles are that we should do everything that we can as a nation to ensure that we’re producing safer, smarter, more sustainable, and resilient food supply chains. And I’ll touch on them real briefly and close in about 60 seconds.
How we ensure the safety of foods matters, and right now, the way FDA versus USDA does that is using two very different risk paradigms, one primarily continuous inspection versus one using a less frequent, risk-based model that needs to be improved. I think there’s a lot of work to do on inspection modernization living this new digital and data age. So I think there’s ways for us to make the food system safer.
Second, I think we have to create smarter supply chains. We’re going to have 9.57 billion people on the planet by the year 2050. Yeah, farmers and growers are innovating, but we know we need to run smarter supply chains, and so anything that can digitize the food system and make it smarter is something that the nation should get behind.
We need more resilient supply chains. I spent a lot of time in the private sector working on supply chain efficiencies, but the pandemic has taught us all too well that it’s not just about efficiency, but it’s about resiliency as well. And I think we all have concerns about the effects that’s happening on the planet with climate change, and we need to be focused on more sustainable food systems. We can’t do it with the regulatory patchwork what we have today, and so, longer term, we do need a single food and food safety agency. And so, with that, I’ll pause and I look forward to answering any of your questions.
Hon. Stephen Vaden: Mr. Yiannas has set a very fulsome table for us. Dr. Brashears, the same three questions to you from a USDA perspective: How safe is our food? Is a reorganization of the agencies that handle food safety necessary, and if it is, how should it be done?
Dr. Mindy Brashears: Thank you, Judge Vaden, and thank you for the kind introduction that you gave me. Again, I have spent over 25 years in academia as a scientist, so I’ve studied food safety and microbiology my entire career, aside from the time I spent in D.C. as Undersecretary for Food Safety, but I take a very science-based and data-driven approach.
As Frank mentioned, USDA really differs from FDA in our approach to inspection. USDA operates under continuous inspection, which means that every single animal that came through — We had oversight of meat, poultry, and processed eggs, and every single animal that came through was inspected by a veterinary inspector before harvest and as well as after harvest, and every single processing plant has an inspector on site at least once a day.
Again, FDA is more of a less continuous process than USDA. Am I saying the food supply isn’t safe? No. I think that we all will have experienced food safety reprocessing around the world, and I do agree that the U.S. has one of the safest food supplies in the world, if not the safest, but we can do better.
I don’t think that you fall back on that statement and say it is as good as it can be. There’s always room for improvement, and that’s one of my perspectives as a scientist. We’re always pushing the bar forward, not only in technology, but also how we solve problems and approach problems in order to make things better and to improve public health.
Now, whenever I was at USDA, I was able to oversee some landmark changes, such as modernization of swine inspection and implementation of egg HACCP. Those two events were really categorized as Trump administration initiatives; however, it took 25 years to get to both of those points in the process.
And that really brings up an important point when we talk about how we do this. I think, number one, we cannot politicize food safety. We have to bring the best minds together that have had the experience in the system, the best scientists, the best government leaders together to come up with an approach to make the food supply safe.
The comments that Frank made about the parents of children who have been lost or been injured from our food supply, that just shouldn’t happen. We have to be able to put politics aside, put all of those things aside, and come up with an approach that is best for the public for the United States.
Now, whenever I was in the government, I was able to establish a fellowship program, having a passion for universities. And I wanted to do this because there was really a lack of understanding from vet schools as well as university programs on what FSIS did, and I wanted to initiate something to bring in the greatest and the best talent.
That is where we have another gap. We need to be able to bring in the brightest and the best into FSIS, into FDA, whatever the food safety agencies look like, and be able to recruit them from the industry or from academia. Industry and academia pays well. We have to have a pay structure that compensates these individuals if they come into the operation.
In terms of restructuring, I did have the opportunity to work very closely with Frank when I was at USDA, Frank in the FDA. Now, it’s my understanding that — You know, we had monthly meetings. As Frank mentioned, we signed an MOU for the oversight of cell-based foods.
We also had to oversee outbreaks, recalls, and in some of our plants, they are under what we call dual jurisdiction. So, for example, if we had a Romaine lettuce outbreak, you might have a prepackaged Romaine salad or Caesar salad that only had Romaine lettuce and FDA ingredients, but then, on the flip side, you might have a Romaine salad with chicken in it.
Now, at our level, Frank and I would have the conversations. It would be very straightforward to us—not simple, but straightforward—in how to manage recall, but then, whenever it went down into the next level or to the inspectors in the logistics of that, it became very apparent that there wasn’t a culture of cooperative and collaborative relationships to work together to get these recalls done, and there was definitely a fragmented system.
Even though Frank and I spoke often at the leadership level, we had a long-term professional relationship, and I think it was very unusual in the way that we interacted with each other. Then, in 2020, Frank and I had the opportunity, with the direction of Secretary Perdue, to ensure the stability of the U.S. food supply during the global pandemic.
As Frank said—and I will reiterate—food safety and food security became a matter of national security. I think that we took this for granted. In the U.S., we never thought, “Oh, we’re going to actually run out of food. There may not be food to feed the people of the United States.” We were on the brink of that, and we had to work very closely together.
I think about those times, and it was so important that there was strong communication, strong collaborative efforts to work together with a common goal to make sure that the public was fed. Now, how do you do this? I don’t have the absolute answers other than putting aside the politics, but I do know, at USDA, I worked closely with the other undersecretaries. We had undersecretaries who oversaw various agencies, such as APIS.
APIS wasn’t just animals; it oversaw plants, vegetables, crops. Same with trade. Even when you look at the research side on the ARS, it included all commodities at USDA, whereas at my level, I worked with Frank in order to include everything. I think that we have to bring things together, I think that we have laid out some of the challenges that we have with our food safety system in the U.S., but I also think that, with challenges, it opens the door for opportunities.
So I’m very grateful to be here today, and I look forward to discussing some of those opportunities and how to move forward and make our food supply safer and to protect public health.
Hon. Stephen Vaden: Thank you so much, Mindy. And, as a reminder to our audience, I already see several questions coming into our Q&A box. So please, if you do have a question that has already come to your mind, don’t wait to type it in; you can go ahead and type it in now and I will take a look at those during the question-and-answer portion. Hopefully, we’ll get to as many as possible.
Dr. Ostroff, as a two-time acting commissioner of the FDA, what say you?
Dr. Stephen Ostroff: Well, thanks very much, Judge. It’s really a pleasure to be here. And I will say that it’s a tough act to follow both Frank and Mindy, who I think are incredibly articulate and passionate about food safety. I’m going to mostly focus on the question of the way the food safety and food regulatory system is structured.
Usually, when I give talks, I like to use quotes, mostly because people say things in a much more clever way than I do. Anybody who worked at FDA knows that I always used to use Yogi Berra quotes, but I’m going to spare you Yogi Berra quotes. Instead, I’m going to start with the one from the Oracle of Omaha, Warren Buffett, who said that if past history was all there was to the game, the richest people in the world would be librarians.
Well, obviously, he was talking about investing, but I think it’s pertinent to the topic at hand because as Frank mentioned, the laws that established our current food safety regulatory framework were developed more than 100 years ago. They were developed for the circumstances of their time, circumstances that bear little resemblance to the food safety landscape of today.
Now, I will say that there are many laws that age quite well. Others may not necessarily do so. And please understand that I do think that the basic framework has aged well, and that is the establishment of FDA and USDA food safety regulatory responsibilities, both fundamentally lie in the idea of protecting the public and holding industry accountable by preventing and controlling the consumption of unsafe, or what we refer to as adulterated food, and making sure that our food is properly labeled and branded.
That’s basically what both USDA and FDA do, but I don’t think that what has aged especially well is artificially dividing up the food supply into a completely different oversight paradigm for some parts of the food supply, the part overseen by USDA, from the oversight paradigm that’s in place for foods that are regulated by FDA.
As has been pointed out, the paradigm for USDA is that, until it’s inspected by USDA, it’s not safe for consumption. The exact opposite is true for FDA. The presumption for the foods that are overseen by FDA is that they are safe for consumption until FDA figures out that they may not necessarily be unsafe.
It makes me wonder, the folks that put these laws together 100 years ago, if we somehow transported them to the current time, what would they think? They’d probably think that the laws worked because our food supply is certainly a lot safer than it was 100 years ago when these laws were formulated, but I also think that they probably say, “Why are you doing a lot of things the exact same way how that you were doing them 100 years ago?” Or let me use a quote from Ronald Reagan: “Status quo, you know, is just Latin for the mess that we’re in.”
Now, I’m not sure that it’s quite a mess, but it sort of does raise the fundamental question: Does it really make sense to have two separate parts of the federal government doing essentially the exact same thing? I don’t know of any other area of federal oversight, where you have two completely different parts of the government essentially doing the same thing.
Now, I will say there are perfectly good reasons to inspect some types of food commodities more frequently than others based on risk, but it doesn’t quite seem to me that we take contemporary risk into account when we’re currently deciding how frequently we need to monitor foods.
So, in anticipation of this presentation, I went out yesterday — Since I’m retired, I have the time to do this. I went out to my local grocery store and walked up and down the aisles and saw many of the things that Frank was referring to. I found, in the refrigerated part of the grocery store, egg beaters, which are pasteurized processed eggs that have the USDA seal on them, sitting right next to unpasteurized, raw agricultural commodity eggs that are overseen by FDA.
Now, I’m hard pressed to think that somehow the egg beaters are riskier than the shell eggs happen to be. I walked down the frozen foods aisle and saw the frozen pizzas, the USDA seal on the pepperoni pizzas next to the cheese pizzas that don’t bear the USDA seal. I walked down the canned foods aisle and saw some soups with the USDA label and other soups without the USDA label.
I walked over to the seafood counter, and unfortunately, there wasn’t any catfish there, so I couldn’t see it there. But I’m hard pressed to find any data that suggests to me that somehow catfish is riskier and needs continuous inspection than tilapia or salmon or flounder or shrimp. It just doesn’t make a lot of sense.
And so we’re in a circumstance where somehow we’ve convinced ourselves that it’s more important to continuously monitor and inspect frozen pepperoni pizza, but we don’t require that of infant formula and we don’t require that of bad salad. Somebody has to say to me that that makes sense. It’s crazy. It’s inefficient. It makes no sense from the standpoint of trying to optimize existing government resources, let alone acquire additional resources. It isn’t good for industry, especially for producers that require dual regulation.
I’m not aware of any other advanced economy that has such a strange way of dividing up responsibilities when it comes to something as important as food safety, so I continue to be befuddled about why we believe the status quo is okay. If it was up to me, I’d blow up the whole thing, but of course, it’s not up to me.
But it sort of brings the quote from George Bernard Shaw. “There are those that look at things the way they are and ask why. I dream of things that never were and ask why not.” I do believe that we can do things, more effectively than we’re currently doing them in terms of mitigating risk more efficiently in terms of using the resources that we currently have, and serve industry and the public better. And so I will end my comments with those thoughts and turn it back over to you, Judge, and open it up to questions.
Hon. Stephen Vaden: Thank you so much Dr. Ostroff, and for each of you for those very thoughtful remarks. I’m seeing the questions pile up. We’ll get to them shortly, but first, I want to encourage some crosstalk among our panelists. If I heard properly, all three of you expressed frustration with the current food safety regime and recommended changes.
Dr. Brashears and Dr. Ostroff, you pointed quite notably at the different regulatory assumptions that govern an FDA-regulated facility versus a USDA-regulated facility, most notably that, if it’s a USDA regulated facility, there’s going to be an in-person inspector in that facility every day, whereas if it’s an FDA-inspected facility, that is not going to be the case; instead, it’s going to be sporadic and based upon a schedule of stops that the inspector must make over many plants over a particular given time period.
And you, Dr. Ostroff, noted quite well that it’s unclear why we would think that salad is less dangerous than meat, particularly given the very poignant examples that Mr. Yiannas started out with to remind us that these are not abstract issues at all; they truly affect real Americans every day.
My question for you all is, do you have a preference in terms of which set of regulatory assumptions you believe would best protect the public? Would it be the USDA in-person inspector in the plant each day model, would it be the FDA’s somewhat regular visits, but not in-person everyday model and taking a look at statistics, or is it something different entirely? Mr. Yiannas, I’ll start with you, and then the other two can chime in.
Frank Yiannas: Judge, I’ll try to be very succinct, but it’s a great question. I think neither paradigm is sufficient for the 21st century. You know, I like to say that, in the 20th century, we were living in the industrial age; in the 21st century, we’re living in the data and digital age. And neither paradigm, in my view sufficiently is preparing ourselves for the transformation that’s going to happen.
I think we’re going to see a paradigm shift in the compliance oversight method. Foods and food establishments are assets. They’re physical assets that increasingly can be given a digital identity and a digital footprint and a digital voice. And as this transition happens—and it’s going to happen; more equipment and processing facilities are leveraging sensor technology and IOT, foods are increasingly having sensors on packages so we can monitor time temperature, microbial methods are changing, interventions are changing—I think we need to move to a more data-informed oversight method.
As opposed to continuous improvement or as opposed to FDA’s inspections of once every five years, if it’s not a high risk, or once every three years, we should move to a model where we’re capturing as much data and insights about the products and facilities that we regulate, capture other sources of data and information that might be relevant, use these new and emerging tools like machine learning and artificial intelligence to make better sense of it, and do the inspection that’s needed when it’s needed at the right time and at the right place.
I’ll close by this simple analogy. The way I changed the oil of my automobile today is very different than I did in the 20th century. That was the old paradigm. That was the old food safety inspection paradigm. People would tell me I need to change the oil every 3000 miles every four months. What do I do today? I change it when my automobile tells me I need to change it. I know it seems like blue sky and way off, but we will look back 20 30, 40 years from now and we will say the way we’ve been doing food safety oversight for 100 years is outdated.
Hon. Stephen Vaden: Go right ahead.
Dr. Mindy Brashears: I’ll jump in here. I agree with everything that Frank said. Now, at this point in time, I do believe in continuous inspection of animals because you have to detect the disease. That has to stay in place, but I don’t think that continuous inspection with someone on site in person necessarily has to be in place for all food all the time. There are different levels of risk.
I think one of the challenges that we have is the inability to adopt technology; for example, virtual or online automated inspection or even incorporating microbiological testing. The government has brilliant scientist. I worked with the most brilliant people at FSI—and I told them that hopefully every single day—but the ability to adopt a technology is very, very slow to incorporate that into our inspection systems.
Like I said, egg HACCP, that took 25 years. HACCP, that’s an old concept; it shouldn’t have taken 25 years. So part of the process is getting through the red tape, and being able to adapt and implement new technology, the automation, the virtual ability to do inspection and taking the best of each system and combining it so that, ultimately, we can prevent the illnesses, prevent the outbreaks, and detect things more rapidly.
Dr. Stephen Ostroff: So I’ll be a bit more succinct, which is that, with the current structure, it’s never going to happen. What we need is, in terms of what’s the right inspection frequency, I think, Frank largely got it right, which is, it needs to be a continuum, and it needs to be a continuum based on our understanding of what the risk is associated with that particular commodity.
There are some commodities that need to be inspected very, very infrequently because, based on their track record of decades and decades, there’s rarely, if ever, a food safety problem associated with that commodity. I can’t think of in my lifetime, ever seeing an outbreak related to ketchup, as one example, but a system that requires continuous monitoring of a pasteurized egg product and doesn’t require that in a far riskier item like bagged salad isn’t getting it right.
And we’re never going to get it right when we have this artificial split between two different parts of the federal government where there are laws that govern where, if the commodity falls into this part, this is the way it has to be done, and if it falls into this part, this is the way it has to be done. That’s never ever, ever going to get us there.
And so I, like Frank mentioned, am a proponent, that it’s time that we knock down these artificially created barriers to taking a holistic approach to the food supply, have a single entity that could make decisions about the frequency in the appropriateness of inspection for every single commodity category that covers the entire food supply.
I’d love more inspections; I think they’re important. I agree with Frank that we have a lot more tools these days to help us not necessarily need to always be inspecting, but inspections are pretty important. We’re never going to have the resources to do continuous oversight and inspection of the vastness of our food supply and the number of entities not only domestically, but internationally, and we have to understand that a huge part of our food supply comes from outside the country. We’re never going to have the resources to be able to inspect with the frequency that we do with the USDA-regulated commodities.
So I think it’s important that we break down these silos, that we come up with a contemporary risk-based approach to how we oversee and monitor our food supply, and my guess is that, at the end of the day, we would end up with a safer food supply.
Hon. Stephen Vaden: One final big-picture question before I turn into the questions I have lined up from our audience members. Dr. Ostroff, you have suggested that we need one food safety agency alone. I know our other panelists kind of leaned in that direction. Dr. Brashears, you talked about how relations were often good among senior-level political appointees between the agencies, but when it came down to the people who were called upon to implement often career civil servants, they didn’t always work well together if it was a USDA-FDA joint project.
Did those concerns and agency culture concerns tilt in favor of, using Dr. Ostroff’s metaphor, when we blow the whole thing up, creating a whole new agency that can create a whole new culture, or do any of you believe it is possible for that one food agency to be one of the two existing food agencies and us to have an increased level of safety?
Frank Yiannas: This is Frank. I’m happy to take a quick start at that. And I’m glad Ostroff has the courage to say just blow it up. I’ll try to be a little bit more diplomatic, but I’m a student of organizational culture in large organizations, and culture matters. It really is critical sometimes.
As scientists, we think it’s the vague, abstract stuff, but I can tell you, working for large organizations—most of which were larger than the FDA—that it’s the soft stuff; organizational culture, that’s the hard stuff.. One of the best experts on organizational culture, Edgar Schein, said the most important job of the leader is the creation, strength, and formation of culture and, when and if necessary, the destruction of culture.
I think starting fresh with a new single food agency, while very difficult, would probably be the right thing to do. Mindy is right. People thought our government didn’t work together, USDA and FDA. It did when Mindy and I were there. And I don’t want to sound like knights in shining armor, but we had a relationship long before federal service. But that relationship didn’t always exist at the top above us, right, Mindy, between the secretaries and the commissioners?
And so we rolled up our sleeves and got the work done, but then even underneath us, there was reluctance between the two organizations. They’re very territorial, and there’s a culture there, without question, of sometimes not being willing to work together. So I would say, in an ideal world, you create a new single food agency, and you bring the resources together and, like Dr. Ostroff says, the best thinking from outside and inside government, but start anew.
Dr. Mindy Brashears: And I’ll comment on that. And one thing that that I touched on in my opening remarks is that we have to be able to bring people into a new agency. I do agree that I think the best approach would be a single freestanding food safety agency, not only with USDA, FDA, but also elements of CDC for traceback and investigation of outbreaks.
You know, CDC was in Atlanta. Frank was in Silver Springs. I was on the National Mall, and just the physical distance is challenging. It is so much more than just one new agency. There are issues with communication, IT, sharing information, how do we get that rapidly. And that’s not only at the federal level; you have to communicate quickly at the state level and even all the way down to the local health department, so it is a major undertaking to reorganize this to be able to make rapid decisions.
And also, there is a labor issue, getting the best experts in. As I, like I said, mentioned in my opening remarks, there are highly intelligent individuals within the government, and it’s valuing what they have what they bring to the table, and then finding the best and the brightest from industry, from academia to bring in to create a new culture, to create a new structure in order to have the greatest impact.
So it goes beyond just creating that agency. There are a lot of levels and a lot of layers of things you don’t even think about beyond the science, beyond the politics that will have to be restructured to make this successful.
Dr. Stephen Ostroff: Yeah. Well, let me jump in, Judge, because it’s a really good question. Now, I never worked at USDA. I worked at FDA. I worked at CDC. I worked at the state level as well. And one thing that I think is true of the USDA workforce that works on food safety, as well as the FDA workforce that works on food safety, is that both of these groups are passionately committed to ensuring the safety of the food supply.
And I wouldn’t say one is more or less passionate than the other because they both really, really are committed and believe in what they’re doing. And I think that, given that baseline, there is a way to bring these folks together and get them all to be marching in the same direction.
So I think that, even though it’s being done differently by the folks at USDA than the folks at FDA, at the end of the day, they all understand that it’s about safe food, and that’s what they’re committed to. And I think that that commitment could likely overcome any cultural differences that might exist between the two agencies should somebody bite the bullet and decide that we would all be better served with a single food safety agency that isn’t distracted by other things that both USDA as well as FDA do.
You know, as I say, I think from the standpoint of resources, we would use them much more efficiently. And again, I’ll come back to the fact that I believe, as Frank pointed out from all the data, things haven’t necessarily been going in the right direction, and I do believe that if we simply make better use of the resources that we have available to us—let alone new resources, which I also think are needed—we’d have better outcomes than we currently have.
We deserve better than what we’re currently experiencing, and we’re not going to get it with the status quo. I hate to say it. Now, another quote that I happen to like is that change does not necessarily guarantee progress, but we’re not going to get progress without change.
Hon. Stephen Vaden: All right, well, let’s get to some of our audience questions. Dr. Ostroff, I’m going to direct this first one to you, but others are welcome to chime in on it. Our questioners have noted that you have suggested that the United States is basically alone in bifurcating its food safety structure. They want to know whether or not there is any foreign country that you think provides a particularly good model for food safety regulation that America should look to for guidance and perhaps emulation.
Dr. Stephen Ostroff: Well, I’ll start by saying the circumstances in the United States are really considerably different than in many other parts of the world, so you have to account for that. But as I mentioned, among all of the advanced economies, I’m not aware of one that has this type of bifurcation.
The only one that readily comes to mind is our neighbors to the south, Mexico, which does have a bifurcated system, so you have one agency that handles manufactured foods, and you have another that handles the raw agricultural commodities. I’m not sure I’d necessarily point to them as a model that we want to follow, but if you look at virtually everybody else, they poll their inspectional and regulatory resources into a single agency. And so I think you could look at virtually any of them and say, “Why were they able to do it and we can’t?”
Hon. Stephen Vaden: All right. Next question, and this actually goes back to a First Principle matter. One of our questioners wants to know how much of food safety is personal responsibility, rather than government responsibility. The questioner points out that, when we go out to a restaurant, how well the cook does his job can have quite a lot to do with the safety of our food, and wonders how much, even in the best system of governmental regulation, we can lower foodborne illness in this country.
So I guess the bottom line question is how much is personal responsibility on us as the people who prepare the food, and how much of that can we eliminate the factor in with better regulation from the source of the food itself? Mr. Yiannas, I’ll posit that to you first.
Frank Yiannas: Yeah, it’s a good question. You know, in our profession, we often say there’s a shared responsibility for food safety, but let me be crystal clear: The industry has primary responsibility for producing safe food for their customers and the consumers that they serve. Government doesn’t make food; it’s the regulators.
And if you think of the incident that I’ve spent a lot of time on, infant formula, you can criticize FDA—and there’s criticism to go around there—but Abbott fundamentally failed to maintain a plant in sanitary conditions and adopt the most modern methods to minimize contamination.
So industry has the primary responsibility. It’s shared among industry because we have a very interconnected and distributed food system, so there isn’t one single actor or actress in the industry continuum that can do it alone. They’re relying on farmers to provide them products that are not contaminated or minimal contamination if they’re going to do some type of cooking steps. So it’s a shared responsibility. Everyone has to do their part.
I think, Judge, we have to strengthen what I call a food safety culture in our nation and among establishments because, when it’s part of our culture, the entities that are producing food will do it the right way, not because the government is holding me accountable to it, because I’m responsible. I realize it’s a fundamental obligation that I have. If I’m going to serve food to others, it has to be safe.
Having stated that, I think we all know too well there has to be a system of checks and balances. Our Founding Fathers knew that all too well, and that’s where the regulatory oversight system comes in. Regulators create the rules and the guidance documents based on science, like Mindy said, that are the minimum standards for industry to comply with.
And then, like Dr. Ostroff said, I’m a firm believer that you have to have that, to use quotes, “trust but verify” mechanism. Occasionally, the government has to come in and verify that the industry is, in fact, doing what they’re supposed to do. I think we need to use more modern tools and we need to do it in a more dynamic, risk-based method, but it is a shared responsibility. And if industry did it right 100 percent of the time, then there’d be less need for regulatory oversight.
Hon. Stephen Vaden: Let me follow up with another question from one of our questioners that plays off on that, Mr. Yiannas. One of our questioners wants to know—and Mr. Yiannas or any of you can take this—of the proposals that you have made here for reform, do you think any of those proposals would have prevented any of the unfortunate deaths that have been discussed by us today, whether it be Lucas with the E. coli or the horrible issue with baby formula that filled the latter part of your tenure, Mr. Yiannas? Can anyone here point to a specific reform that they believe would have stopped one of the recent incidents from occurring?
Dr. Stephen Ostroff: So let me just start by saying that’s a theoretical question. There’s no way of actually knowing the answer to that unless we do something different and see if the outcomes are different. I did want to follow up from the question you just posed to Frank, if I may, because, as I mentioned, I worked at CDC for a long time, and so I have followed patterns of foodborne illness for many, many years.
And the pandemic offered a really interesting opportunity to examine the question that was being asked about the relative responsibilities and the relative contribution to foodborne illness that occurs at the manufacturing facility or at the farm versus at the restaurant versus with the consumer.
One of the things that we noticed in the United States, as well as every other country around the world, is that, during the pandemic, the incidence of foodborne diseases and foodborne outbreaks dropped precipitously. Now, obviously, there were very significant differences in terms of what we were doing during the pandemic than we usually do.
People were paying a lot more attention to personal hygiene, as one example. People weren’t eating out to the same degree that they were. The manufacturers had to switch from the types of products that they were producing. It was an interesting experiment to be able to examine the question of the relative contribution of different parts of the infrastructure to foodborne illness.
Unfortunately, a lot of other things change, too: how likely people were to get diagnosed, the amount of effort that the public health system was making to looking at foodborne illness as opposed to being completely moved over to dealing with the pandemic. So sometimes it’s not easy to really be able to discern why things dropped the way that they did, but I do think that there are some fairly instructive lessons that we can learn from looking at what happened during the pandemic in terms of helping to inform us about where the problems happen to be that I wish we would pay more attention to.
Frank Yiannas: Can I try to tackle the question that was asked about it, some of the things that we talked about today, could we have prevented some of the examples. I agree with Dr. Ostroff; it’s a hypothetical, but listen: Smart government policies and not relying on status quo are the only things we can do for prevention. And I’ll use infant formula as an example.
You know, the plant that was in question had found Cronobacter sakazakii in finished product. The policies and the rules did not require them to notify FDA. So if we move forward with advancing science, working with a greater sense of urgency, changing the culture, and adopting smarter policies, yeah, had the company reported that to the FDA, I think FDA would have been obligated to act faster.
If you look about the supply chain implications of that crisis, which one infant formula manufacturer out of 21 going down and the drastic effects that had on a lack of supply chain availability to our nation, parents concerned about whether they’d get their infant formula, think about the role of government policies played there.
Government program that purchased, rightfully so, over 50 percent of all infant formula to make it available, but the policies that they had of assigning sole source contracts at the state and how that policy severely created the consolidated infant formula industry that we have. So to answer the question, yeah, I think a single agency that’s putting together all the issues of whether there’s available product, contracting, smarter food safety policies, yeah, I think we can prevent a lot of these with smarter regulations and smarter policy and smarter regulatory oversight.
Hon. Stephen Vaden: All right, I want to remain cognizant of time, but I have one last question that I’d like to pose to all three of you brought on by one of our questioners, and hopefully it can be answered with just a yes, no, and maybe an extra sentence or two. The FDA, as we mentioned at the beginning, has proposed to reform itself after reviewing the Reagan-Udall report. Some people do not think that the proposal goes far enough. Other people think it has an opportunity to work.
To each of our three panelists, do you believe the current proposal, as put forward by the current FDA commissioner, Mr. Califf, is sufficient to address the food safety issues that you have identified and believe need addressing. We’ll go in the order that we spoke. Mr. Yiannis, you first.
Frank Yiannas: I think it’s well intentioned, but it misses the mark. The answer is no. It brings back some of those four elements that I talked about in my opening comments under a deputy commissioner, but it doesn’t even go back to, I think, the organizational structure that Dr. Ostroff had at one time. So well intentioned. It falls short. Now is the time to go bold, not to take half measures.
Hon. Stephen Vaden: Dr. Brashears?
Dr. Mindy Brashears: I think it identifies many of the shortcomings and the challenges, but I also agree with Frank. It doesn’t do enough in terms of problem solving. It points out a lot of the challenges, but doesn’t have enough solution-driven information and action to actually make a long-term impact.
Hon. Stephen Vaden: And Dr. Ostroff?
Dr. Stephen Ostroff: It doesn’t go far enough. I’ll be quite blunt about that. You know, the one thing that I do appreciate about the USDA structure is that the folks that set the policy and the folks that do the inspections are within the same organizational entity. And that’s what you need to really have the most efficient and effective oversight, and the reorganization that was announced the other month doesn’t do that, and so I think it falls short.
Hon. Stephen Vaden: Chayila, we’ve come to the end of our time, but I’m proud to say we’ve noted on a point of agreement. Our panelists don’t think enough is being done and the proposal’s not good enough. So there you go.
Chayila Kleist: Well, thank you. Indeed, on behalf of both myself and the Regulatory Transparency Project, I want to thank our experts for sharing their time and expertise today. I know our audience really enjoyed it, given the number of questions. I’m sure we could have gone for longer, but I appreciate what you’ve given us, and I want to thank our audience for tuning in and participating.
As always, we welcome listener feedback, [email protected]. If you’re interested in more from us at RTP, you continue to follow us on all social media platforms, as well as find more content like this at regproject.org. Thank you all for joining us today. We’re adjourned.
International Center for Food Industry Excellence, Texas Tech University
Former Deputy Commissioner for Food Policy and Response
United States Court of International Trade
Federalist Society’s Administrative Law & Regulation Practice Group