B (6:44)

So we continue to see recalls and outbreaks of FDA and USDA regulated foods top the headlines. In the third quarter of this year, FDA was involved in 145 recalls. That's the highest quarterly total since quarter one of 2020. Now, continued outbreaks and recalls, particularly those that result in severe illness and fatalities, are a sign that the system maybe isn't working as well as it should be. And looking at the current system for outbreak investigations, the question I'd like to pose for our discussion today is how can we do better? Now, outbreak investigation work is already continuous and complex, and it's made even more complicated by the fact that state and local agencies, as well as three different federal agencies, cdc, FDA and usda, can share responsibility for jointly handling outbreak investigations. In multi state outbreaks, the federal agencies work alongside state and local health departments to determine the cause of illness. So coordination, collaboration and transparency among all parties involved are critical to the process, but not always easy to achieve. Now, while preventing foodborne illness is always the goal, we also know there's a lot to be learned by doing better outbreak investigations, getting to the root cause, and sharing those lessons with regulated industries, which is something that doesn't always happen. So how might we achieve better outcomes in outbreak investigation, and what would that success look like? Here with me on the podcast today are four experts with deep food safety backgrounds in regulatory and industry. Frank Giannis, Drew McDonald, Dr. John Besser, and Dr. Craig Hedberg. So welcome gentlemen, and thanks for being here. Now, when we look at the reasons for wanting to improve foodborne outbreak investigations and root cause analysis processes, I kind of see it as threefold. So first, from the consumer side, we see too many people getting seriously ill or injured from food. Second, companies are having to spend a lot of money on recalls and reputational salvage. And third, more foodborne outbreaks and recalls means more and harder work for the federal and state agencies with oversight of food safety. So I'd like to kick off our discussion today by asking, how do you think we're doing with outbreak investigations today and how would you rate our current outcomes? Frank, would you like to kick off the discussion for this question?

C (9:11)

Sure. Thanks Adrian. I love that question. How are we doing as it relates to foodborne disease surveillance and outbreak investigations? And thank you for that great setup on the why really, we're having this conversation today because investigating foodborne outbreaks matters. You said our goal should always be prevention. There's no question about it. But without question, better foodborne outbreak investigations will lead to better prevention. That's why it matters. Investigating an outbreak, identifying the food involved, and pulling it from the marketplace is not good enough. Sure. That results in what we call secondary prevention.

D (9:47)

Right.

C (9:47)

If you pull a contaminated food off of the marketplace, less people will become ill. But how do we actually investigate those outbreaks to prevent reoccurrences? And, Adrian, the list of food vehicles responsible for outbreaks over and over again are as long and we aren't really learning lessons that we're sharing with regulated industries to prevent them from happening over and over again. And I can go through the list. I would break down your question, how are are we doing? Into two components. I would say, how are we doing on foodborne disease surveillance? Detecting signals of illnesses, cluster illnesses, knowing that they're attributed related to food. And then the second part is, how are we doing on foodborne outbreak investigations? Digging down into root cause, what are the lessons learned and sharing that with regulated industry? I would say on foodborne disease surveillance, if I use something like the scale of 1 to 10, 1 being we're not doing very good at all, and 10 being we're fantastic, I would say on foodborne disease surveillance, Giannis would say we're an eight. I'm an adjunct professor at Michigan State University. I have a hard time giving A's, and so I'm not going to say 10. And there's always room for improvement. But, you know, I think some of the best progress we've made in the area of food safety over the past two decades has been foodborne disease surveillance. Whether in the early days it was pulse, field gel, electrophoresis, FoodNet, WGS, all of that has informed, you know, what we know about food safety and strength and prevention. And we're still doing a really good job at that. I can tell you. There were many times when I was at the agency, I would advise commissioners, when we're going up to the Hill to testify in front of Congress, and I would review their scripts, and commissioners would want to say we have the safest food system in the world. And almost every time, I would strike it with a red pen or track changes, say, don't say that, ma', am, or sir, say we have among the safest food systems in the world, but you can say we have one of the best, if not the best, foodborne disease surveillance systems in the world. Now other countries are catching up, so I would say maybe an eight, and that's good. On foodborne outbreak investigations, I would rate us a 4. If you think on a scale of 1 to 10, 5 things, sometimes we're good and sometimes we're not, I would say needs improvement. And that's because, as I said, I just have seen the same outbreaks happening over and over again, and you don't have to look very long and to see what they were this year alone. What did we have? A salmonella outbreak associated with cucumbers in a particular grower in Florida. What did we have last year, that same grower involved in an outbreak with salmonella and cucumbers? There are other outbreaks that can go on. We've seen listeria over and over again and similar type foods. Why aren't we transferring the lessons learned to other producers so that they don't have to say, make the same mistakes? I could go on with you. Name the food category, but there's a real gap in our ability to investigate these foodborne outbreaks, drill down to the contributing factors and root causes, and then disseminating that information to regulated industries so that they can make changes so that they don't have the same occurrence. And so that's how I rate it. I don't think I'm being too tough. We have to get better at foodborne outbreak investigations.

B (13:05)

And Drew, what would you say, how do you think that we're doing on outbreak investigations today?

E (13:11)

Yeah, and I like Frank, I love this question. I agree pretty much 100% on the front end in terms of our surveillance. And I've had the privilege of working around the globe and in other locations and countries, and it's just not the same. We monitor on a whole new level here in the US but to Frank's point, they are catching up. I mean, in fact, they're, they're using our systems and they're going to. And so I think we're going to see a big change coming there soon. And I actually also agree on the outbreak investigations. I think there's a lot of opportunity. I do believe that we've seen an increase in attention. I think there's, I hate to use this term, but there's really good intentions, a lot of focus on it. But I, I don't know if we're focused the right way. You're, you know, we talk, I hear conversations. It's about funding, it's about resource allocation and all those things. I just don't know if we're set up right to get to where we need to be in terms of prevention. And I'm not saying that it's the job or the explicit role to get to root cause, but at the very least, we need the outbreak investigations to identify, I would say, more specific variables that regulators and Industry can use alike to make improvements. Frank mentioned the cucumber event that happened and produce is near and dear to me. But I would like to point out we have multiple facilities that are USDA and FDA jurisdiction. Some one, some the other, some both. And so we see side by side how the different approaches take place. But you know, FDA gets the most attention. I think their communication, the, the core table, all these things, there's really an effort to kind of communicate. I just don't know if we're communicating the right things that are going to drive the change that we need. When you look, in fact, one of the recent podcasts right on Food Safety Matters was talking about the perception, was it IFIC that did the perception is, you know, we're not getting better, that recalls are at all time high. It's arguable, you can look at it, but the perception is there. So I don't think we're getting better. I know we're not getting better. And I think that's the huge opportunity and I really look forward to the conversation today to kind of talk through some ideas.

B (15:44)

Now, John and Craig, you both have worked in the areas of outbreak investigation and public health surveillance. I'm really curious to hear your thoughts on this question as well. John, maybe you can tell us a little bit about your experience from the federal side.

D (16:01)

Well, I actually have experience both on the federal side and the state side where I worked with Greg Hedberg in Minnesota. But yeah, I've been involved in hundreds or perhaps even thousands of outbreak investigations and I've seen a steady improvement over the years as there's been new developments both on the epidemiology and on the laboratory side. And I think, as Frank suggested, I think that part of it works really well and we truly are the most robust system in the world. I've also worked in different parts of the world. I think it's due to 30 years of really inspired leadership, including some of the people on this call. Just quickly, I'd like to go over what, for sake of the audience, how these outbreaks are detected. Most outbreaks are actually local due to improperly prepared food, and that's not really what we're focusing on today. But the vast bulk of outbreaks in the United States are local and these are usually discovered by citizen reporting. They'll call up their local health departments or perhaps physicians will notice a cluster. These outbreaks detected involving mass distributed food items are occasionally discovered in this way, but most often it's due to foodborne disease surveillance, which is, I would argue, the most sensitive way there is for detecting unrecognized problems in the food supply. And it's been fabulously successful. The way it works is a patient takes medical care, a doctor will diagnose it an illness. If it's one of these reportable diseases like salmonella or listeria or sugar toxin producing E. Coli, it's mandated in every state that it be reported to the health department. Cases are interviewed in some states more thoroughly than in other states. And the states then voluntarily report that data to the cdc. We have a national system for sharing of information called outbreak net and isolates from cases of certain types of diseases like salmonella and listeria also go to state health agencies where they're subject to DNA sequencing. And there's a national database at the CDC where all these DNA fingerprints, so to speak can be compared. And we look for clusters. And this has gotten fabulously more sensitive over the years with, with new technology. So the states monitor for and local jurisdictions monitor for local clusters and the CDC monitors for multi state clusters, national clusters and international clusters.

C (18:55)

And.

D (18:58)

You don't see these in the news all the time, but there's between 30 and 60 of these multi state international clusters being investigated every single week and many, many more in the states. If they trigger investigation, there's a interview, data is analyzed and if it appears that there's a FDA or USDA regulated product, those agencies are then pulled in at that point. So all these isolates from all the different states go into a central database as I mentioned, and the FDA and USC also contribute isolates from these pathogens to PulseNet. And FDA has its own complementary system called Genome Tracker. If there a linkage between a product or environmental isolate is found and between that and human cases, this creates an instant hypothesis which is very powerful. It doesn't always happen, but sometimes it does. The CDC then works with the regulatory agencies when to declare an outbreak and on communications and at least until recently CDC it was a member of Infosan, which is a global alert network for foodborne emergencies. So what's working? Working well with the system. There's been a huge overall impact both there's been actually good data on the amount of medical costs and cases saved by the PulseNet activities and the real number is perhaps an order of magnitude larger than that. I think importantly these investigations have stimulated industry wide changes and I think we'll talk later about how we can even improve that much greater than if we have the root cause analyses. But pretty much every commodity of food in the United States has been Benefited, you know, leafy green vegetables, vine vegetables, beef, chicken, fish, ready to eat foods, stone fruits, melons, flour, even some weird things like freedom and rattlesnake powder that we didn't, I didn't even know people consumed. But of course we could. As as good as it's already working, we, we can, we can do, we can do much better. There's been really cutting edge technology, PulseNet, there's a data management system called Cedric that pulls together all the different data streams to allow real time analysis, AI tools and we really have world leadership in the epidemiology methods. There's distributed responsibility between all the states and local health departments and federal agencies. I think what works well is there's a dedicated investigation unit at FDA called FDA or works for most pathogens, not all or most commodities and we can talk about that later too. And the identification of clusters and at least development of hypotheses is relatively rapid. And increasingly we can identify small clusters. There's also been really great communication with the agencies developed over the, over the years. There's weekly cluster meetings with all of the agencies and the states as appropriate. And there's at least until recently embedded liaisons at CDC from the agencies and vice versa. CDC people embedded in fda. And I think I'll stop there. But I think overall, as Frank suggested, the systems for developing for hypotheses and detecting clusters works very well.

B (23:05)

I appreciate that background, John. I think that's really helpful for our listeners to hear a little bit more about how exactly do these investigations work. And you also talked about what you think is working well with the outbreak investigation process. I'd like to ask Craig to give his thoughts on, you know, how do you think we're doing with outbreak investigations and what do you think is working well? What elements of the outbreak investigation process are working for us right now?

F (23:32)

Sure. And I want to follow up on both what Frank and John said because I think there is a, you know, we're better at detecting outbreaks than we are at investigating them. And there's a number of reasons for that. One is a lot of the resources John was pointing to are operating on the, on the federal level. They're, they're really looking for large multi state outbreaks. Those are the ones that generate all the headlines and those are the ones that get most of the energy from CDC and from FDA and the USDA if it involves a meat or poultry product. But the process John described for how outbreaks are detected has a multiple steps between when somebody gets ill and when they get linked to an outbreak. So that's two to four weeks, usually between when somebody gets ill, before we can really link them as part of an outbreak. And that time delay is one of the challenges we have with outbreak investigations. We're trying to reconstruct what people ate in the week before they got sick, and we're asking them about that two to four weeks after their onset of their illness. Memories are fallible. We've developed a lot of tools to try to recreate what people actually purchased and would have eaten during that time frame. But. But that's a. That time delay creates a challenge. And it creates a challenge because, you know, one of the things that we might like to do, if we have a hypothesis that a particular food item might be the source of an illness, we like to collect whatever information we can about the description of that product. If it's a. If it's a commercially distributed food product, a bag of lettuce, a manufactured chicken, there will be labeling on the packaging really useful to help us identify what the source of the contamination might have been and even something about, you know, how that product might have been processed two to four weeks later. Most people aren't keeping that packaging material around, so we lose important information about the identity of the product. And so there's a more tedious traceback product process for. For trying to identify things. And this has been, you know, I know one of Frank's most important initiatives at FDA was to really try to improve our ability to trace food products back from where the point of consumption is to where the point of production was. In addition, you know, a lot of food, it's, you know, we. As an epidemiologist, if I'm asking somebody about what they ate, they'll say something like, I ate a hamburger. Well, you know, people think of hamburger as being ground beef, but if you go into a restaurant and order a hamburger, you've got a bun, you've got the meat, you've got whatever else gets put on. It might have cheese, it might have onions, it might have lettuce, it might have tomatoes. All of those things are competing hypotheses that need to be sorted through, traced back. And that process can be very difficult and time consuming, you know, to try to work through. And so most of our public health agencies. John mentioned the collaborative nature of our system. We have a very distributed public health system in the United States. The states are really independent of CDC at the federal level. In many states, it's a local health department that actually has the primary responsibility for Identifying and following up with cases so we can have an outbreak, a multi state outbreak that could involve hundreds of different local agencies, each of whom has a small piece of the investigation to be responsible for. And very few of these are dedicated people working on foodborne disease surveillance. They're people who might have 10 other responsibilities. And so we're constantly sort of juggling priorities at the state and local level to, to find time to conduct the interviews and potentially go back and re interview people to get additional details about what food items they might have had. So these, these are some of the challenges and, and some of the reasons why the investigations aren't as always effective as our ability to detect that something's going on. And that's really, you know, from the local public health perspective as well. Many of our public health practice agencies, you know, their focus is on stopping the outbreak. And once they feel like the outbreak has been stopped, you know, they have to move on to the next problem that they have to confront. And so there isn't necessarily a lot of incentive at the state and local level to do the detailed investigation investigations to look at the source, look at what happened and look at why that happened, to get into the root cause analysis that's so critical for giving tools to industry that they can work with to promote better prevention measures down the road.

B (29:09)

And so when we're looking at what might be working well, Craig, any thoughts on that? And I know Frank and Drew are going to want to speak to that as well. What might be things that in the outbreak investigation process that are working for us at the moment?

F (29:23)

Well, I think, you know, as John laid out, you know, we've made a lot of progress. You know, we have a system of federal support for foodborne illness surveillance and outbreak investigations. CDC has an EPI and lab capacity grant program that supports a lot of this activity at the state level. And we've actually shown in some recent studies that we did that, you know, that there's a direct relationship that the amount of funds that CDC puts into this ELC program is directly related to increased outbreaks being detected. And it's those outbreaks being detected then that give us the opportunity to begin to identify those root causes and to take the next step to prevention. Those investments, you know, are critical for the foundation of our food safety system. And you know, the, the, one of the challenges we face, you know, with, with financial constraints, you know, at the federal and state level is maintaining those investments and realizing the value that they have for the population.

B (30:45)

Frank, what are your thoughts on what's working well with our current outbreak investigation system.

C (30:50)

Yeah, thanks. Those were great overviews, obviously, by Craig and John. And, you know, I'm looking at this, Adrian, from the perspective of decades of experience in the private sector, including the world's largest retailer, and then the honor and privilege of serving as deputy commissioner from fda. So very, very much a public and private sector perspective. I would say two big ones for the audience to, to make sure they double down on it. Number one, you've heard it loud and clear here is signal and cluster detection. You know, we're the best in the world. Some of the men on this call have been working on this for decades. John, I like your comment that it took leadership, but our ability to detect foodborne illnesses and clusters of illnesses and attribute them to food has really been impressive. You, you asked me what's the number one thing that has advanced food safety in the 21st century? I'm sorry. Despite the 15th anniversary of FSMA coming up, I would not say it's FSMA. I would say it's pulse, field jelly electrophoresis, and now whole genome sequencing just game changing. And hats off to the men and women that have done that. You know, the states, you heard the important role they play in getting isolates and sequencing them, sending them to cdc. The cdc, John, detecting these clusters and then asking the right probing questions and working through the states to collect questionnaires. And even, you know, the federal agencies, fda, you heard John say, has something called genome tracker. You know, we solved outbreaks because we would test a positive product coming into the country, import, for example, shrimp positive for salmonella. We sequence it and lo and behold, we find out there's human cases and outbreak solved. So our ability to detect signals and clusters and link them to food is a success story. The second one that I think is worth mentioning, I'll pass it over to you, Drew. Is Craig coming from the state. And John, you have a state background is just, you know, applause to the men and women who do this work at the state and local level. When I was at the agency, oftentimes people would want to credit us for solving outbreaks. I can tell you it's the states that are doing the really hard detective work. And there have been outbreaks that just wouldn't have got solved without their amazing work. I remember in the fall of 2019, we saw E. Coli with leafy greens again, and it was the state of Maryland that had the intuition and the ability to go into a patient's home, get an unopened bag of Salad and find the outbreak strain and open bag of salad that very quickly allowed us at the agency, rather than do what we did in 2018, pull all Romaine nationwide, we say, well, it has to be romaine because the trace back from Salinas and limit the scope of that national advisory. So great work last year. What did we see? Lead intoxication with children that wouldn't have been solved. It wasn't for the great work of some men and women in the state of North Carolina. Right. The lead in the wanobana and cinnamon spices. Right. Now what are we dealing with? Infant botulism that wouldn't be on our radar. Wasn't for great work by the men and women in the state of California. And so I think another thing that's working really well is the great public health and detective and kind of shoe leather work done. Traditional epidemiology crank at the state and local level. And we can't, we can't ease up on that.

B (34:19)

Yeah, absolutely. And guess, Drew, what are your thoughts on what is working well?

E (34:24)

Yeah, I think that we've definitely hammered the fact that the surveillance and detection is improved greatly. And I, I would point out just. And I think John even referenced this a little bit. I think one outcome that I, I don't think I want to ignore because this hasn't, this hasn't been a failure, this has been a success is I think the industry, and I'm obviously vested in the produce side, but, but other industries as well. But I'll say the produce industry especially has responded to these, that these events occurring have resulted in significant change implementation of food best practices, commodity specific guidelines, famously the leafy greens marketing agreement for California and Arizona. But we see it with melons, we've seen it with papayas. So in a maybe twisted way almost that is one thing that is working well, that people are responding. Whole genome sequencing. I think we've really emphasized that as a tool and I think we need to continue that. But it's not an answer, it's a means to get to an answer. But I think there's a slightly overemphasis on it. I'm a little concerned about that. But I think overall whole genome sequencing is such a strong fact on the ground. I also would like to point out that FDA with each, especially FDA with each outbreak investigation, they've gotten better over the years of asking better questions. You know, before they would say, tell me all the farms that you use to make this salad or the farm. And now they know that if it's a spring Mix or another. There's multiple products, multiple locations that potentially go into that. There's harvesting, there's cooling, there's all these other process steps. And I've seen over time they've evolved their questions, they're asking much better questions. And I think in part that's because they're figuring it out, but they've also listened to industry and, and as an industry, we've developed a document for them that it's. Well, it's really for industry, but I know FDA's looked at it too, just, you know, the kinds of things that you want to ask questions on and the ways to ask them. So I think we have more tools, we have better knowledge. I would also say that and Craig talked about this, it's a, you know, two to four weeks sometimes before they can really respond. But with whole genome sequencing and previous signals, they're able to jump sooner. And we've seen fda, not my company in particular, but in general responding very quickly, getting people out in the field or getting them out into facilities much faster than ever before. And that's great, especially if they're sampling and they're looking at things. My caution on that, though, is just because that's the initial hypothesis doesn't mean that as new data comes in that they need to change as quickly as two. There tends to be this doubling down sometimes. And with whole genome sequencing, I don't think you can ignore the outliers as I think much as that happens. But I think there's some things that are working really well. We just need to harness them better. And talking about the states, the states do an amazing job, but not every state is created equal. Not every state does the same work for all different reasons. It's not that some states are worse at it, it's just they're maybe not equipped or the experience. I don't want to embarrass Craig, but as a former Minnesotan or born in Minnesota, Minnesota has always seems to be, you know, on top of it historically. It they just, they do a great job. And I think I want to look at those examples. Whenever someone says what's, what's working well, I always want to say the follow up to that is, okay, if that's working well, how do we do more of it across the board? And I think that's, to me, kind of the springboard question from that is there's opportunities to improve and formalize that because I think what we. Well, we can come to the next part. I'll stop there. Thank you.

B (38:41)

Yeah, thanks. Drew. And I think that is a really important point is, you know, looking at what we are doing well, and then how do we make sure that that does get, you know, that there's uptake of that in other localities and states and, you know, also by the agencies themselves, the federal agencies. So, you know, we've kind of set the stage by looking at how we're doing overall on outbreak investigations and what working well. But the next thing I'd like to move to, and I'll ask Craig to lead us off on this, because he already alluded to this in your previous comments, is, you know, what improvements should we be making to the process to get better outcomes and what do those better outcomes look like? Craig, if you wouldn't mind leading us off on this.

F (39:27)

Sure. Thank you. And just, you know, I'm currently at the University of Minnesota, so I haven't had an operational role in any outbreak investigations for 25 years. But, you know, the Minnesota has continued to be sort of a model for outbreak investigations largely because of what I think is a culture of public health. And Frank has, has been a big promoter of culture in the food safety world. But I think we always had the standpoint that foodborne outbreaks were public health emergencies. We had to jump on them, and we believed that we could figure out what was going on and then solve the case. And I don't think that that belief is actually widespread throughout most of our public health system. So I think one of the things that we need is to really develop that sense of both urgency in our public health investigations and a sense of importance that the work, it fundamentally matters and, and that we really continue to ask questions about that outbreak until we get to a point that we understand, you know, what happened and why. We're never going to be able to investigate all of our outbreaks that way. But, but I think that going in with that mindset is, is a critical piece of how we need to improve the system.

C (41:03)

That's great, Adrian, if I can build on that. Craig I appreciate it because we spent a lot of time talking about what's working and we rated. I want your readers and listeners to remember, I said, hey, there's a difference between foodborne disease detection and foodborne disease investigation. On the investigation, I rated it a 4 on a scale of 1 to 10. But what can we do better, Adrian? When I was at the FDA, I actually asked that question, and Dr. Hedberg is being humbled. I hired him to come in and actually take a look at how the agency, the FDA was investigating Foodborne outbreaks. And what could we do to get better? Because we had made a lot of progress over the years. He wrote a report, an independent report. It's on FDA's website to this day. As I recall, he interviewed 25 men and women across the agency. He interviewed of executives at usda, including cdc, developed a list of recommendations based on those recommendations. We published something at that time under the era of the new, under the auspices of the new era of smarter food safety, a report that was titled FDA's Foodborne Outbreak Improvement plan, and it's still on the agency's website. But there were four distinct concepts, Craig, that we kind of fleshed out from what you viewed that I think are areas for improvement. Number one, tech enabled traceability. Now, I don't know the traceability alone is going to help us solve all these outbreaks, but one of the things I do on a regular basis, I look at the outbreak table that core publishes. I'm grateful to say that happened during my tenure there. Starting to be a little bit more transparent. Men and women across the country, public taxpayers, needed to know what were the outbreaks the agency was investigating. But if you look on any given year, you know, it's generally 50, 60% of the outbreaks they're investigating, they're never able to identify the food vehicle causing the illnesses. Just think about that. The majority of the outbreaks they're investigating, they can't even identify the food. Now, this is not a criticism of them. It's just a criticism that we need to get better at the information collection. Craig, as you mentioned, questionnaires and asking people what they ate. You more modern tools. You know, these days, almost everybody leaves some type of digital footprint behind where they've been and maybe even what they've consumed. Can we modernize capturing information so that we can triangulate, inform a hypothesis on what might have caused these illnesses? And I think if we applied a little bit of creativity, Craig, to your point, saying we can do better, a spirit of culture that we can't do better, we might be able to do that. And in fact, there were outbreaks when I was at the agency. We started to develop a tool, Adrian, that if we could get the traceability data in the form that we're asking for it in the new food traceability rule, rather than having, you know, FDA staff draw traceback diagrams like you've all seen on the FDA website, take computational power to take the key data elements that are submitted to FDA and let computational power tell you what legs and what data Sources seem to be more associated with illnesses or not. And we solved an outbreak that way where the traditional traceback mechanism told us to go to Salinas, but the new data driven computational method told us to go to Florida and test the ingredient sources from a food product. And lo and behold, computational power won the day. The analogy I use, it's like using instruments to fly a plane. Sometimes pilots didn't want to use the instruments, but sometimes the instruments could be better than the human mind. The second thing we identified was root cause investigations. And in fact, you know, it wasn't that long ago in 2020 and 21 and 22, I would tell the commissioners that came in, I'd say, ask an FDA staffer what's a root cause investigation? And if you ask five people, you're going to get five different answers. @ that time, we hadn't even developed an SOP on how to properly do a root cause investigation. And so that's an area that we need to continue to work on. I assume there's been some advancements since I've been gone, but we need to do better at doing root cause investigations, not stopping at what is the product, but how do you dig down, identify contributing factors and then really having confidence that this is what led to the outbreak. The third thing was, just after you've done that is analyze the data and disseminate those learnings. I will ask you, we've all seen big outbreaks over the past two years, right? Tell me which outbreak you've seen reported with great granularity and detail so that you have confidence you know what happened and probably there won't be a single one that somebody can say, yeah, I saw a great detailed outbreak investigation report on the FDA website. We know exactly what happened and you won't be able to give me an example where, hey, and we've disseminated this information to similar regulated industries and even ask them to make changes. And so the third area that I think we need improvement on is once we do the root cause and if we do them, is then share those learnings with other. I say that's the difference between knowledge and experience. What's experience? Right. You all tell the three year old, don't touch the hot stove. What does the three year old do? They touch the hot stove. Why? Because they're not listening. You've given them the knowledge, but then they have a consequence. Well, the analogy I like to use, Adrian, is not everybody has to touch the hot stove. If we can share this information, we can give the industry experience of the lessons learned because of the mistakes of others. And then the last one that I'd love to see us get better at is establish some performance measures. Are there any performance measures on how we're doing an outbreak investigations? You know, is it good enough to show up on site 10 days after an outbreak investigation? Sometimes I can remember it takes a long time to document these assignments and get people on the ground. Drew, I'm glad you're saying that we're getting there faster. Perfect example relevant to today's conversation. Bihart Bihart Powdered infant formula by Hart reported almost three weeks ago that they have found c bot and unopened containers powdered in through formula. We haven't heard anything else in terms of test results from federal agencies. And so having some performance measures, I mean, when. How quickly should we be able to get to the facility? How quickly should we be able to get results? How many of them should we publish reports for? And I think, you know, it would serve us well to document some performance standards and rate ourselves on how well are we doing on the investigation component of.

B (48:03)

Outbreaks. Yeah, I think those are some really good points, Frank. And I appreciate you bringing up, you know, some of the work that you also did previously @fda on, on this front and trying to improve the outbreak investigation system and how we, how we track and trace these things. And I guess, you know, I'd also really love to hear John's perspective on some of the things that we could do to improve the system. You know, having done a lot of work with, with the CDC and at the state level, you know, I'm curious as to your thoughts on what would success look like with.

D (48:36)

Improvements. Well, thank you. As we've already heard, the timeline, some of it is just inherently long. Surveillance is a long process, but there's one particular part of it that actually could be shout out to Craig Hedberg here, who pioneered a method for interviewing cases which was called team diarrhea, which the. The news media has had a great time with. But the process is to interview cases with a long questionnaire, finding all of their exposures as soon as the illness is reported. And this is when they're most likely to remember what they ate. While this has really become the national model, the states are. Has been pointed out are all very different from each other. They have different level of resources, different level of expertise. And I think it would be really worthwhile to expand this model to the whole nation because this is where perhaps we can get the greatest bang for the buck in increasing the success level. And we've also heard from Frank about traceability, and I think that will also help in getting to the answers more quickly and for more.

B (50:04)

Vehicles. Great. Well, thank you, John. And, you know, I'm really curious also to hear from Drew on this from the industry side, which is a little bit of a different perspective than what we've heard so far. Drew, what are your thoughts on what we could do to improve the outbreak investigation.

E (50:20)

System? Yeah, I'm glad Frank brought up Craig's report because I think it outlines really well a lot of the opportunities.

C (50:29)

To.

E (50:29)

Improve the one thing that is in the report but doesn't come out right. It says it, but we do have a fragmented food regulatory system. At the end of the day, I don't know. I think it was great that John outlined how outbreaks are detected in that process because I think it's always good to remind folks of that, even in the industry. But I don't know the extent that people really understand our overall food regulatory setup from the states. We've talked about their role, but it's very fragmented, especially between USDA and fda. CDC will go out of their way to say they're not a regulatory agency, because they're not. But those three main groups working together, I've been flat out told they're not beholden to each other. So cdc, usda, fsis, and fda, they're there to inform each other. And I think it's. It can work and does work sometimes. And I think other times it's depending on personalities in the room and such. And again, this is from the outside looking in and asking questions. We have a vested interest in understanding where they're going with traceback and why they're asking these questions. And it's often difficult to navigate that. Usda, obviously we know them for meat and poultry, but they also do catfish. And FDA regulates other foods, most other foods. But it's a very bizarre kind of split in jurisdiction. There's reasons behind it that are interesting and kind of makes sense when you understand them. But when you step back, it is confusing. And FDA has jurisdiction over a cheese pizza, but USDA looks at a pepperoni pizza, FDA looks at shelled eggs, and USDA is looking at other egg products, and the list goes on. And so kind of recognizing or understanding this seemingly absurd structure, it's been, you know, proposed, of course, to have a single food agency. I'm not saying that's going to happen anytime soon. That's going to take an act of Congress. But the way I talk about it, with folks is we need to at least act more like a single food agency. And again I think there's definitely times where they have especially on the front end but on the back end when we're trying to really figure out what happened, that's where it sort of falls apiece and the very system becomes hampered from being able to address preventative opportunities. And at the end no single agency really has that responsibility and so there's no final accountability on that. And so I think the opportunity is all the words we've been saying, collaboration, cooperation, transparency, you know, communication and that includes with industry as well some of these things that take two to four weeks to find out. Many of us industry right know right now if we see a very specific marketplace with a specific outlet that's selling a particular product, many of us right now today know who supplies that and, and, and could provide a trace back right now. So I think there's opportunities to adjust some of the steps for expediency, efficiency and all of us kind of understand why and what and the important questions. I do think we've gotten better at it, but it's not the structure, there's not a systematic way to do that. And so I think we have to look at that. I think the other big, big opportunity is once a food hype. And I've seen this change over the last couple years and I don't really know why, maybe Frank or Craig or John can tell tell me but it seems that some of the traditional recommendations, and this is in Craig's report with C4 which is essentially the best practices for outbreak investigation talks about doing case controls, you know, if especially with whole genome sequencing right now it's such a fact on the ground and if you have let's say 100 people that are within 0 to 1 steps apart for the same illness strain and you interview because of all the constraints we've talked about, you could only interview a handful of them and you come up with a predominant food item. I often will say that it looks like they're more and I think Craig, you've talked about this misattribution where it becomes more of a what's the dominant product in that marketplace versus is that really what is the food vehicle? And I think on early signals and withhold gene that's fine to start down that path but the moment new information comes in I don't feel like we're equipped to adjust the hypothesis. In fact I would argue there tends to be this doubling down effect and some of those and many of the whole genome sequencing, the whole genome sequences get ignored, those cases, because they don't fit that initial narrative. And I mean this in an objective, you know, from an objective kind of critique standpoint, but sometimes those outliers, even a few outliers that absolutely did not eat the cucumbers or did not eat the poultry item, whatever it is, those could be the most important to actually getting to the bottom of things. And so I think an adjustment in, and maybe in just the nimbleness to go back and forth and accept being wrong initially, I think is okay. I mean, that's science, right. And so I think there's just a lot of opportunities in that regard to fine tune what is already. The pieces are there, the people are there, but really pull it all together in a coordinated.

B (56:30)

Fashion. Well, thanks for those thoughts, Drew. And I think you set us up really well for the next topic we want to tackle. When you talked about the importance of acting like a single food agency. And I want to kind of allude to Frank, you wrote a recent op ed piece where you proposed the idea of a National Foodborne Outbreak Investigation Board following the model used for airlines with the National Transportation Safety Board. So can you walk us through this proposed idea? And I'd love to hear every everybody's thoughts on how this might work for a similar model for.

C (57:02)

Food. Sure. I'd love to start it off and then hear from my colleagues because I haven't asked them specifically, other than this idea has been around for a while. I know I've had conversations about this with CDC officials in years past. And, you know, if you pause to think about it like I think, Drew, you suggested, this is in no way, shape or form being critical of what's happening today. It's not being critical of the men and women at the state and local level or at FDA or USDA or cdc. It is just this idea of continuous improvement of the system, not critical of people, but of the system. And Adrian, I can't help but think about airlines, you know, because that's an area where we're all very concerned about safety. If you look at that accidents or death due to airlines, they have plummeted over the years. Clearly. We know there's lots of reasons why that has happened. You know, they've designed safer aircraft. The air system control is better and smarter. But one of the things they do exceptionally well is when a tragedy happens or even a near miss, they investigate those with rigor. Right. And they have a body called the National Transportation Safety Port that really insists on getting to root cause, Craig. They have that culture that every airline accident can be prevented as opposed to, you know, some accidents happen, no zero tolerance. And it struck me that one of the things that's missing here is a similar type mindset and approach. And so what I proposed is, you know, having a national foodborne outbreak investigation similar in some way, shape or form to the ntsb. And that would allow us to achieve a couple of things. Number one, you've already heard here that investigating outbreaks is a team sport. You know, it involves local and state and CDC and sometimes FDA and usda like we've seen here with these meat pasta meals, right? At first it was usda, they ruled out that it wasn't the meat or the poultry. And then maybe it's the pasta. And by the way, just for all of the listeners, remember that one. I doubt we're going to get any type of report that provides any clarity that prevents us from having let the letting something like that happen again. But you need a quarterback, if you will, and that's the National Transportation Safety Board, a quarterback that says we're all going to work together, but somebody is accountable, somebody will do call the plays, be the quarterback for all of these multiple agencies. Now I think, I think in all fairness, you might hear some within the system say we're already doing that. But I think stronger accountability under a new structure would be really, really good. Personally. The other thing that would do is provide a little bit of independence. You know, oftentimes regulators, it depends on who you are. Right. These agencies are made up of people. Some get a little bit protective of the products that they regulate. And so I think some independence. And what you'll never see is an agency be self critical, at least not too self critical. Right. We heard excuses of, you know, whistleblower letters, getting lost in a mail room. If you have a little bit of independence, that independence could allow both critique of the industry and the mistakes that they've made critique in a constructive fashion. And it may be even critique of, well, you know, our regulations don't address that. Maybe we didn't conduct the investigation the right way. So I think that that would provide a little bit of independence. I think it could facilitate greater coordination. You know, I was just looking at this recent airline disaster that happened with ups, right, in Nashville. If you look at how the NTSB assembled a panel there, they have people they're talking to, people that include not only the faa, it includes ups. It was the UPS aircraft that went down. It includes Boeing, the manufacturers of the airplane And I think with a national foodborne outbreak type board approach, maybe we could be a little bit more inclusive and bring people to the table, including industry or maybe equipment manufacturers, and get data from them that might inform some of the root causes and strengthen prevention. And then, and I think another benefit will be we can actually develop some of these performance measures that I talked about. Say, are we investigating these outbreaks the right way and good enough? And the ultimate goal, I think Adrian, is for us to actually get to root cause, really know with confidence why it happened and what can be done to prevent it. And you know, one of the things the National Transportation Safety Board does with FFA is they disseminate information to other regulated airlines to take action, do the inspection on this type of plane or this type of piece of equipment. And to be candid with you, doing this for almost four decades, I have never seen that happen. To Drew's point, industry does a good job. We've learned a lot because of post village electrophoresis and whole genome sequencing. The industry tries to respond, but I think just continuing to improve by doing a better part on investigations, I think this could go such a long way in truly preventing additional foodborne outbreaks. And while, you know, sometimes we need new regulations, I think this, a simple move like this I would predict would be game changing in terms of strengthening foodborne disease prevention in our.

B (62:50)

Country. This is a really interesting and innovative idea and I would love to hear everybody's thoughts like. So let's start with John on, you know, what do you think about the idea of a National Foodborne Outbreak Investigation Board? What would that look like? John, your.

D (63:03)

Thoughts? Yes, I think Frank's comparison with the NTSB and FAA is very appropriate. I'd like to add to that that there's actually a potential mission conflict in investigating airline crashes or foodborne disease. The FAA has, its role is both in industry promotion and industry regulation. And for the NTSB its only role is investigation. So it doesn't conflict with promotion or regulation when investigating. I think the same is true in the food area. The CDC is only involved in, as, as CDC likes to say, in investigation and not regulation. And the FDA core is also strictly involved in investigation, although it is connected to the larger regulatory agency. Not all commodities are investigated by FDA Corp. For instance, a shellfish or infant formula. And this creates some, some real problems. So I think getting all those functions in one place makes a lot of sense. The reason that NTSB doesn't go away is because that system works. And I, I think this would Too. And this is, I know there's some new discussions on the Hill about single food safety agency, and I think we, we need to keep this idea in mind as those discussions go.

B (64:48)

Forth. Yeah, absolutely. And thanks for also bringing up that topic too. You know, looking at the potential idea of a single food safety agency and then also looking at what would it look like if we had one board that would, you know, look at foodborne outbreak investigations. Craig, I'd love to get your thoughts on Frank's proposal and this idea of, you know, a single outbreak investigation.

F (65:10)

Entity. Yeah, no, I think it's interesting and certainly for the big high profile outbreaks, you know, I think this would be appropriate. I think from my standpoint as an epidemiologist, back in the days of the Minnesota Department of Health, we dealt with so many outbreaks that having that level of scrutiny, you know, would really be considerable overkill. But when we look at sort of the large outbreaks, the ones that really start to need to transform our food system, those really warrant that. And I think, think the key piece that Frank talked about is that the findings have to be made public. And I think there are a lot of after action reports that get generated as a result of outbreak investigations. Typically, you know, they might involve multiple agencies, but they, they, they never wind up usually in useful public information. You know, they're, they're always viewed as an internal operational document. And so the fact that that information never leaves the agency really limits the value of the exercise. So I like the concept of the Food Outbreak Investigation Board for those really high profile, important outbreaks. But the independence and then public access to the information are really the two key things that I see.

B (66:42)

There. So super interesting perspective so far. Drew, I would love to hear your thoughts on this, you know, from the point of view of.

E (66:49)

Industry. Yeah, I think all the points brought up, I agree. I mean, it doesn't sound like we're thinking this is a bad idea. Again, I, I think when I look at, well, we look at at least. So the reports Craig referenced are, are available if you dig for them, right. EIR reports, environmental assessments on, on some produce items. And so we, and we don't hide this at all. We, we actually look at those ourselves. We, we retrieve them through foia. And I have a, my team, we review them and say, what can we learn from this? Even an infant formula, even non, you know, foods that we don't do. My line I use is I love to learn from other people's mistakes, but often there's not a lot of Actionable information in it. You know, there's observations. I always look at the 483s. If there's 483s, you know, is this something, you know, are they just saying there's condensate? But are these really the things that resulted in the outbreak? And, and more often than not, I think Frank has said this enough. They don't. There's very few examples where I look at that and say, oh, this is absolutely what, you know, this is what the problem was. And, and like I think Craig said, I liked how he described it's sort of an operational report. These are all the steps we took. But it's not tuned towards really meaningful, useful, actionable outcomes from an industry standpoint and quite frankly from a regulatory, to focus in on things moving forward. Which is why I think we see a lot of outbreak announcements that talk about, you know, it's likely they use the word confirmed, it's linked to this product, they're unable to truly get to that. And I understand the reasons why, but I think we need to change that. I think we can do better. And so having this, this kind of coordinated role, we can take advantage of the skill sets, experience across the board, as I mentioned earlier. And I think John, you touched upon.

C (69:00)

This.

E (69:03)

Core. You'll never see a poultry product in the core table and you're only going to see the products that fall under their items. And it sounds stupidly obvious, but we're not a cohesive food regulatory, you know, system. It's kind of over the board. So we, you know, just at the very sense of someone or something as an entity that's coordinating that. Now I have had this conversation, this is not a new topic and many folks on the different agencies will say, oh, we do coordinate, we do work together and I think at times they do. But even Craig, your example of yes, for national, you know, more, you know, larger multi state outbreaks, this is useful. But I would argue that in the NCBI database which we track often you'll see an outbreak strain from, you know, last year, three years ago, maybe one or two cases that are localized in that state and, and those were attributed in some cases to a food product never actually linked or they were never solved. And so maybe, maybe there is just having someone looking at it differently for even those seemingly isolated related strains showing up. Maybe that's a way to solve these, you know, moving forward. And because many of us internally are monitoring that and saying, oh wow, this could have been a great clue and we'll even call CDC and say, hey, we saw this outbreak strain from two years ago show up. And, and they don't, you know, because it's only one or two, they don't necessarily look at it. But maybe that's an important clue that we're missing. And, and this kind of organization or this kind of system would perhaps address that. And again, I think a lot of this happens, but it's not as formal as it could.

D (70:52)

Be. Yeah, no, I think that's a good point. What we're dealing with now more than any time in history is, is big data. We have these enormous databases. We have potentially enormous, incredible amount of interview data that's available. And it is an extremely big job to go all through that and find all the potential clusters or trends that would be useful. So I think it's really imperative that we keep up with technology. So for instance, right now, even though AI is not the perfect tool that people make it out to be, it will give us tremendous ability to link these subtle signals together. There's just not enough people to go through all this data without some machine intervention. So I think if we want to improve this part of the process, I think keeping up with technology is extremely important. And that requires resources, of course. And then, you know, there's other types of technology that we really, that could help us along the way too. There's big changes in the field of diagnostics, which is in the doctors or the clinic laboratory, which is where this all starts. They're starting to use more and more rapid diagnostic tests. And the states and the CDC all depend on getting isolates from these patient samples, but those are starting to go away. And if we want to keep this going and improve it by speeding it up, we need to have the resources to develop technology to do direct sequencing right from specimens. So I think both on the EPI side and the lab side, there's ways that we can improve this process and at the same time keep it going into the next.

C (72:46)

Decades. Yeah, John, what a great comment. You know, you mentioned earlier in, you mentioned leadership, Craig mentioned culture. This national foodborne outbreak investigation could be the energy which. How do we continue to modernize how we do things? Whether it's how we get traceback data to strengthen traceback hypothesis on which food might cause the illnesses, the innovations that you're talking about with culture independent tests and you know, the long delay in getting sequences, being able to capture food histories a little bit easier because everybody's leaving a digital footprint. I mean, all that's fantastic. That's an add on to One of the things this board can do. But I just want to state, you know, it's come up a couple times here on a single food safety agency. Adrian, I think this could be done without the creation of a single food safety agency. And so while I think all of us would agree, hey, if you were designing a regulatory system for the United States, you wouldn't design it the way it exists today. I don't want, you know, any listeners to say, we can't do this until we get a single food safety agency. We can do this, this proposal.

B (73:56)

Now. Yeah, yeah, I agree. And thank you, everybody, for your perspectives on this idea. And, you know, in the introduction to this podcast, we talked about that need for coordination and collaboration and transparency among all the parties that are involved in outbreak surveillance and also outbreak investigation. Another thing that heard echoed throughout this conversation was speed, the need for greater speed. And, you know, it's possible that if we did have one single national outbreak investigation board, that that would be, you know, something that might be enabled by that. So I think this has been a really dynamic conversation. I really appreciate you gentlemen coming on and, you know, contributing all your, you know, very expert and unique perspectives. And I think this is going to be really interesting for our listeners. I'm sure we'll hear some feedback on this interview. So thank you again. It's been a pleasure discussing how we can improve the foodborne illness outbreak investigation system. And what are we doing well, where do we need to improve and what might the future look like? So thank you, Frank. Thank you, Drew. Thank you, John. Thank you, Craig, for your thoughts and for sharing your ideas with our listeners.

C (75:03)

Today. Our.

D (75:04)

Pleasure. Thank.

E (75:05)

You. Pleasure. Thank.

F (75:06)

You. Yeah, thank.

A (75:07)

You. Thank you again to Drew McDonald, Frank Iannis, John Besser, and Craig Hedberg for joining us on the podcast today. And of course, thanks to all of you for listening. A very special thanks to our presenting sponsor, Michigan State University. To learn more about their master's degree in food safety, visit foodsafety.msu.edu and click on the Master's program link now. You know, we. We love hearing from you, so never, ever hesitate to send us your questions or suggestions to podcastood-safety.com or post a note on LinkedIn, X, Facebook or Instagram. We're always pleased to hear your feedback and to make sure that new and bonus episodes magically appear in your podcast player. All you have to do is click that Follow or Subscribe button in the player of your choice and presto, bingo. All the episodes appear. And while you're there, please throw some stars our way by rating the podcast, especially if you enjoyed it. It only takes a moment and it's good for everyone. And that's it for us today. Our next regular episode will post on January 13th. In the meantime, take good care of yourselves and those around you. We'll talk to you.