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A
Hello, everyone, and welcome to Food Safety Matters, the podcast for food safety professionals. I'm Stacey Atchison, publisher of Food Safety magazine, and I'm here along with my co hosts, Adrienne Blum, our editorial director, and Bob Ferguson, president of strategic consulting. We're going to just dive in. We're just going to go. You ready to go? You guys, let's go. One, two, three, go. All right. So, Adrian, do you have a little sneak peek for us on the interview?
B
I do. So today I'm talking with Jay Berglund, who's the CEO of Aegis Foods, about innovation and egg product safety, including in shell pasteurization technology for raw and poached eggs, and also the role of consumer trust in food safety. I think Jay has some really interesting things to say about egg saf communicate with consumers on technologies that make food safer. So make sure to stay tuned for that interview.
A
Yes, always stay tuned for this. The interviews, it's quite the compendium. I mean, it really is. That's quite a. Quite a library of stuff that we have compiled and we just keep going.
B
So much stuff.
A
So much stuff. So, are you ready? We're ready. The agenda for the 2026 Food Safety Summit is ready for you to take your first look. Visit foodsafetysummit.com today to see all of the great sessions, certification courses, and networking events that we have lined up for you next year. Our educational advisory board has been working very hard to set the major themes so that you can get started. Started on your planning. We'll be filling in all the details soon, but I know that you're going to be very impressed with the scope of what we're building for you. I know I am. So we've also created our. Our event team has created a new interface for the agenda that makes it easier than ever for you to see everything that we have planned for you in each slot during the day. Well, for every day. So you'll also want to check out the exhibit hall and event map. We've revamped that too, highlighting all of the interesting features of the hall, including the community hub, solution stages, tech tents, podcast theater, and of course, all the amazing products and services that our exhibitors will be bringing to you to keep you on the cutting edge of food safety innovation. Oh, and a beer garden on Thursday. Bob just looked at me with big eyes. Yes, Bob, it's true. A beer garden on Thursdays. We're very excited. We've also made some adjustments to the layout of the session rooms and the keynote theater that will make it easier to navigate the space physically. We're always looking for ways to make this a great experience for everyone, so. And there's even more that we're working on that I can't mention quite yet, but it's going to be great. Just keeps getting better. So, as always, I want to personally extend our invitation to you, our podcast audience, to join us for the food safety summit May 11th through the 14th in the year of our Lord 2026. Make your plans to join us in easily accessible and affordable. Rosemont, Illinois. Have they changed their their websites or anything to include how I refer to them? No, we haven't checked. They haven't done that.
C
They should. They certainly should.
A
I think they should. Yeah. Remember, as a Food Safety Matters podcast listener, you save big when you register. Podcast listeners save 20% off of registration fees whenever you register, but if you register early, that's 20% on top of the early bird. So just use the discount code FSMATTERS20 when you register and save. Visit foodsafetysummit.com to check out the agenda and sign up for updates on the conference or follow the summit on Social and become part of this growing community. I did it. I was very excited. It was a lot. But.
C
Well, there's a beer garden and the podcast theater. You should be excited and all that. Everything else too.
A
All that, everything else. Yeah. Yeah. All right, how about some news?
B
Okay, how about some news? So first we want to tell you about a recent multi state outbreak of infant botulism illnesses that's been linked to Bihart brand powdered infant formula. So a total of 23 biohart associated cases, all of which required hospitalization, have been reported across 13 states as of November 14th. A broader set of infant botulism cases totaling at least 92 cases nationwide, is under investigation by state and federal agencies. No other infant formula brands have been identified and also no deaths have been reported in this outbreak thus far. So by heart, whole nutrition infant formula represents just 1% of the US infant formula market. So so FDA doesn't anticipate supply shortages of formula, unlike what was seen with the severe shortages in 2022 and 2023amid the Cronobacter outbreak associated with Abbott Nutrition infant formula produced at the Sturgis, Michigan plant. Before that plant shut down, Abbott Nutrition infant formula represented around 40% of the US infant formula market, so this is quite a bit smaller. Now FDA is co investigating the outbreak with the California Department of Public Health's Infant Botulism Treatment and Prevention Program, which first notified the CDC of the outbreak after noticing a spike in cases of botulism type a infections between August 1st of this year and November 10th, more than 40% of the sick infants who had been fed powdered infant formula exposure consumed Bihart formula. Investigators have collected leftover formula samples for laboratory testing and results are expected soon. Now. Originally, Biohart initiated a voluntary recall of just two lots of its Whole Nutrition infant formula, but on November 11th, the company expanded its voluntary recall to include all Biohart formula products nationwide. BIHART is also conducting its own testing on all batches and plans to share those results as they become available. So in a statement issued on November 11 by Hart asserted that the preliminary test results are not enough to definitively link its product to the outbreak. The company said neither we nor FDA or CDC have found Clostridium botulinum spores or toxins in any unopened can of biohart formula. And they added that a positive sample from an open can of formula lacks scientific basis to establish causation between the product and illness. So this claim runs contrary to a different statement issued on November 9 in which the firm said, today we were made aware by the California Department of Public Health that a single, previously open sample from one of the two two recalled batches of biohart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. The November 9th statement is in line with the information released by FDA. So according to FDA inspection reports and warning letters, Biohart has a history of food safety and hygiene violations at its production facilities, including issues like mold, dead insects and reoccurring roof leaks at its Reading, Pennsylvania facility, cross causing the plant to be shut down earlier in 2025. The firm also received a warning letter from FDA in 2023 after a batch of finished product tested positive for Cronobacter sakazaki, prompting an investigation of the facility. FDA found a roof leak in a production area, lapses in SOPs, as well as lapses in cleaning and sanitation verification activities. At that time, FDA also reprimanded by Hart for failing to conduct a comprehensive root cause analysis of the Cronobacter Cont. In fact, by Heart concluded from its root cause analysis that the Cronobacter positive test result was a laboratory error, which FDA said was contrary to the evidence. So this new botulism outbreak in infant formula is occurring despite FDA's promise to improve the quality, safety, nutritional adequacy and resilience of the US Infant formula supply under its Operation Stork Speed initiative, which was announced in May at the time advocacy groups expressed skepticism over the FDA's ability to deliver on these initiatives, given the significant Trump administration cuts to FDA's budget and workforce.
C
This one is.
A
Where do we begin?
C
Yeah, this, this one, of course, is, you know, another very dangerous one, as they all are, but another dangerous one because it's infant formula. A couple of things about this story jump out to me. One is because botulism botulinum is related to spores, they also have to germinate, so you could have something contaminated that doesn't necessarily cause the disease. The other thing is the spores are not evenly distributed throughout the powders or the formula. So it's the same thing like we saw a couple years ago, where you could have lots of cans uncontaminated, but other cans contaminated. The other thing that jumps out about this story to me is you see the infections between August 1 and November, which is a fairly long time. This is shelf stable type infant formula. So that could be just the way they're stocked. But it also said 40% of the sick infants who have been fed infant formula consumed by heart. Where are the other 60%? And what's the background to that? Unless that just wasn't connected. So there seems to be more to this story, at least as far as the outbreak and, and the detection of it. That's still to come.
A
I think I have a question, but. And I just. Sometimes I'm easily confused. So it happens. But. So total 23 associated cases, all of which. So we've read. I've read this in like, all the reporting, all of which required hospitalization, a broader set of 92. So I don't understand, like, is that all? Or they just haven't linked that to by heart. And so that's why they're saying. I guess that's the answer. There's 23 that they've linked and those all required hospitalization. There are others.
B
I think that's the 92 includes the 23 cases. And actually, I believe after this reporting there might be up to 24 by now.
A
I think this. I checked just before we got on. It's still 23.
B
Yeah. Okay. I think, I think that they're still trying to establish links between them. But I, I also have read some information indicating that there's a certain number of basically sporadic infant botulism cases per year in the United States. This is maybe what's driving the spike. The Bihart formula. So. Yeah, but. But that. California Public Health, Department of Public Health's Infant Botulism Treatment and Prevention Program is the only one in the United States that does anything like this. So they are, they are tracking infant botulism illnesses and they're seeing a spike. So I think more remains to be seen. This is obviously an unfolding outbreak unfolding story and we'll definitely be following this closely. You may have seen we've been publishing material on this several times in the previous weeks. So we'll definitely keep you updated on what the FDA is finding. Also test results from Biohart itself when it publishes those. And if the case count changes dramatically, including cases associated with by heart formula.
A
Well, by, I mean across the board food safety professionals are just going, what? This has been handled terribly. Just terribly. So yeah.
C
And Adrian, you brought up a really interesting point about the infant botulism treatment and prevention program. Not only is it the only one, but on their website I also read that they have the only antidote to botulism. Botulism. I didn't know this before, but it doesn't respond well to antibiotics. In fact, antibiotics can have some side effects just simply based upon what's on their website. But they also have a, an anti botulism antibody treatment that they have an immunoglobin that they have. And I think it's the only one available anywhere. And so I've not been familiar with this program. They've not heard about it before, but they're the only one. And they're the ones that are sort of the center of expertise in the world on this type of infection.
A
Babies. But I mean, babies. Well, yeah, it's just so hard to think about. It's hard enough for anybody to be hospitalized and it's, you know, it's a traumatic experience for the individuals and for families. I can't even imagine when it's a baby.
B
I guess the thing to be thankful for is that at least you know, as of as the time we're recording this podcast, there have been no deaths associated with this outbreak. So lots of, lots of infants coming into the hospital with botulism. But yeah, you know, they are being successfully treated. That's something to be thankful for. But yeah, obviously this, this could very well point to a systemic issue at the plant where this formula is manufactured. If there's a definitive link, which it sounds like there could be a cause.
A
There, I don't really understand. So I was reading about the expansions of their retail. You know, so they're growing. Good for them. Like any, you know, it's the goal of every company to grow. But they, in 2024, their retail footprint expanded over 200%. There was another expansion in 2025 that they're very proud of. And at the same time you have warning letters and things like that going out. And I'm just wondering how it is that you can expand like that with that hanging over the operation. That's a very thing to me. So an open question there, but also just the last statement that you made there at the time. Advocacy groups Express criticism over FDA's ability to deliver on the initiatives of stroke speed as well as other things. I just think in general, with the cutbacks and the layoffs and all of the upset within the regulators, I think most of this is going in the wrong direction. You know, we've, and we're seeing, you know, evidence of that, you know, but so that's concerning. So, you know, how can they respond? Who's even there to respond? Hello, does this department still exist? I mean, we know that operation, you know, we know folks involved with closer to zero and all well meaning and, you know, good stuff going on and then the hollowing out of the agency. So it's a little troubling. Okay, so I guess before we move on to the next story, it's a perfect time for me to mention that yesterday, before we were recording that, we held one of the wonderful webinars that Adrian plans and organizes with a wonderful lineup on dry sanitation and cleaning techniques for facilities and equipment. It was very, very well, like we had an amazing amount of people register and attend that and it's available on demand. If you go to our webinars page on our website, you can find that certainly some great information for folks who are looking to make sure that their systems are, you know, running as well as possible. So another great job there, Adrienne.
B
Thanks, Stacy. And you know, continuing the thread with the infant formula story. So in related news, and really strangely weird timing, on November 10, the Reagan Udall foundation for the FDA published a report detailing insights from four stakeholder discussions held in September on ways to improve U.S. infant formula safety and regulation related to Operation Stork Speed. So those discussions convened a diverse group of stakeholders, including public health experts, manufacturers, researchers and caregivers. Microbiological contaminants such as Clostridium botulinum and Cronobacter sakazaki were not a focus of the roundtable discussions or the report, however. So these discussions focused on three priority comprehensive nutrient review, contaminants and heavy metals, and labeling and marketing claims. So first, stakeholders agreed on the need to update FDA's nutrient requirements for infant formula, which were last comprehensively reviewed in 1998. They also supported incorporating functional health outcomes such as neurodevelopment and microbiome health into regulatory evaluations and called for the establishment of maximum nutrient levels. Stakeholders also expressed concern of the lack of enforceable limits for heavy metals in infant formula and urged FDA to expand the scope of its Closer to Zero initiative to include infant formula products. The discussions also called for stronger oversight of marketing claims such as Gentle, closer to breast milk and All Natural, which are often unregulated and potentially misleading. A public FDA managed database of approved formulas was also proposed to to improve transparency and help families make informed choices. And you can read a little bit more about the stakeholder discussions and the findings in the report at the link in our show. Notes.
A
Well, often not regulated is not regulated. Just they're not, it's not in the Federal Register, you know, unlike organic. So unfortunately, you know, going back into years of that, people are like, I don't know if it's like it's a law, it's a law, it's codified. There are steps you have to do. This means, this, it means that. It means that there are very specific things about what organic means and how it's certified. Not so with natural, which is suggested or informally means no artificial or synthetic colors or flavors, but again, unofficial.
C
I think we saw that.
A
Sorry, that's a pet peeve there.
C
I've never mentioned that before.
A
No, I've never mentioned it. Sorry.
C
No, I, I think you'll find we mentioned this in, in talking about infant formula in the past. I think it was the last POD or the one before where infant formula is very heavily studied as far as nutritional requirements and what they do. I think you'll find that if the FDA has not looked at this since 1998, that there's a lot of science that's available that they could catch up on with with the manufacturer, since a lot of this is, like I said, very, very heavily studied, particularly since they know that infants only have one source of food. It's the other reason why some of these outbreaks are so easy to track and associate back to where they happen because they, they only have one food to track. And the CDC folks have told us that in the past. The recommendations in here make a lot of sense though as far as standardizing claims with scientific evidence as opposed to just making claims that no one quite knows what they mean. What is better, what is best, these kind of things make sure that you have some sort of claims make sense, evidence based contamination limits, you not only have changes in the formulation, but you also have changes in the diagnostic test and the test used to measure contamination. We've talked about this, that you can get down to very, very low levels. And people have said that because milk is a main ingredient in formula, you have certain limitations on what you can remove. And there's going to be trace levels of certain, I'm sorry, trace levels of certain metals that are at such low levels that perhaps they have no impact at all. But we can measure them. That's one of the things that they need to make sure that they have some science based on that. Regular reviews of nutrition science since it's also improving. So what we can see, what we can tell, what we understand about this, particularly things like the microbiome which they mentioned, that's all fairly new. And I'm sure If it's the FDA's information is from 1998, none of it's current. So that's something that would be, sounds like a really good recommendation. The other thing is harm, they also mentioned harmonization with international standards, which I think is great. It does not say accept blindly international standards. It says harmon, harmonize with international standards as a starting point. They specifically say in the report as a starting point. But then using science based evidence to see is this standard that's out there, one we want to use, can we learn from that? But we're not automatically just going to cross off international and write in US and call it a standard like sometimes happens. So I think that all makes a lot of sense that it's not just a rubber stamp on someone else's work. But if the work makes sense, let's use the information so it sounds like they're on the right track.
A
And harmonization, that just means that's a baseline that everybody has to agree to. And then you can certainly exceed that, right?
C
Well, you can, you can certainly exceed it. But the thing at least, so I'll give you my pet peeve is just to say that well, those folks over there do it this way. So there. Why don't we just do it like that? Well, if they're right, I think it's a great way to learn. But it doesn't mean that, that they're necessarily not mistaken or not seeing something like anybody else would. Otherwise you can make the analogy that why doesn't California just write in new. Take New York's laws and make them California laws. What's the big deal? There's, there's probably a lot of things that are considered there. So it's the same thing with international standards. And again, who standards have a certain reason they're in place. Oftentimes they're much more focused on the developing world, which means that standards that would be perfectly acceptable and a huge improvement for certain areas of the developing world may not be what you want in the US Or Western Europe or something like that. So all those things have to be considered, I think.
A
Right.
C
But it sounds like that's exactly what they want to do.
B
Yeah, thanks for those comments, Bob and Stacy. I think this is a pretty interesting discussion on all things infant formula. And I do find it interesting that the stakeholder discussion for the Reagan Udall foundation, they looked at contaminants and heavy metals, it says, but they didn't discuss Cronobacter or Clostridium botulinum, which I think is interesting. So it kind of makes me wonder what contaminants other than heavy metals they looked at. But anyway, I'm sure we'll hear more about this coming out, so we'll make sure to keep you updated now. Next in news an analysis of publicly available FDA inspection data by ProPublica shows that foreign food safety inspections conducted by FDA have hit a new low after Trump administration budget and staff cuts. ProPublica determined that in March of this year, the number of foreign food inspections conducted by the agency dropped by nearly half compared to the monthly average of 110 that was seen in the previous two years. By the end of July, the number of foreign food inspections conducted by FDA was nearly 30% lower compared to similar periods in the previous two years. In May, FDA announced its intent to expand the use of unannounced inspections at foreign facilities that produce regulated goods. Although the agency has failed to meet this goal, however, historically FDA has struggled to meet its inspection targets for both foreign and domestic facilities that were set by Congress under FSMA. A 2025 report from the US Government Accountability Office uncovered that FDA has never met its FSMA mandated foreign facility inspection goals. In 2019, when FDA conducted the greatest number of foreign inspections, the agency only completed 9%, or 1,727 inspections of the target number of 19,200. So since the inauguration of President Trump, however, the already under resourced FDA has experienced two rounds of mass layoffs, budget cuts, and an FDA spending freeze that required inspectors and other FDA staff to undergo an arduous and delayed process to get travel and purchase expenses. Pre approved investigators, who are responsible for paying off their own credit cards used for agency expenses, were left waiting as a backlog of unfulfilled reimbursements climbed to more than $1 million. A number of FDA inspectors who could afford to leave took voluntary resignations, which significantly reduced the size of the inspector spectra. It so neither FDA nor the U.S. department of Health and Human Services responded to ProPublica's request for comment or data. So Bob, I know you had some thoughts on the data that ProPublica used in their analysis and what those findings actually mean.
C
Yeah, a couple things. There's a lot of moving parts here. One is as you look at the data, the number of facilities changes every year as well. So when you look at percentages and the number of inspections that they do, it is all different on a different baseline. So a lot of those numbers can change even if nothing's changing. But to put some of these numbers in the story into perspective, there have certainly been reductions in the number of international inspections being completed, but also domestic inspections as well. And the number of inspections post pandemic has not really recovered from the pre pandemic numbers. So 2023 versus 2017. So those were down in between the pandemic as well. So there's another moving part. There were some things that happened during the pandemic when they scaled back that have fully come back. So depending upon the year that you, you, you look at, the post pandemic ones are still down about 20%. And that also is probably exacerbated by the current budget issues. Adrian, that you mentioned, the international goal is to get to roughly 16%. My numbers of 120,000 facility. And like you mentioned, they really only get to about 9% of that goal, but the goal is only about what, 10% of the entire, not 10%, about 5 or 10% of that entire number. So they're not trying to get to most of them to begin with and they're not meeting the goal to even get to the right fraction of that. So the goal is like you mentioned, Adrian, 19,000, 20,000. But roughly they get to 2 to 3,000 on a regular basis. So the FDA is not doing that many inspections versus the number of plants to begin with. The domestic goal is similar with 20,000 based upon high risk facilities every two to three years and others every three to five years, which is those congressionally set limits. And of that 20%, they were really getting to somewhat less than, less than half of that goal. So the number of, of the number that they're off these goals has been always quite far off to begin with. The fact that it's up and down based upon certain things going on now is troublesome, but it's not the real reason why they're not getting to most of these plants. They really never have. And in some respects it's not as if of the 80,000 plants that you have in the US 120 broad that they're trying to get to 100% of them every year anyway. So there's a lot of moving parts with the numbers and you have to be careful to say what the, what caused them to move recently versus all these other causes that are going on at the same time. So there's certainly an issue here. The other thing we've talked about before is, is I think it's, it gets you on the wrong track to say that food plants are inspected by the fda and that's the main mechanism by which they, they, they're kept on track, if you would say, or kept them as a main enforcement mechanism. It's not as if the FDA shows up at all these plants to begin with. A typical plant in the US will probably get an inspection every three years, sometimes less. So that's not really how these things are enforced. More of the inspections that keep people enforced are through the audit schemes like gfsi, ISO certifications, specialty programs like Gap Seafood, Leafy Greens Alliances, or the states that have their own programs. And with the international programs, you have national programs too. So if a, if a company is producing food and local. Exactly. So if a company in a corporate. Oh, you said, yeah, exactly. Their own. Right. So if they're. Well, we talked about some of the giant retailers that have their own inspection programs or they hire somebody or they have insurance based on. Upon your liability insurance, where the insurance companies. So there's a whole range of inspections that these plants get that aren't necessarily from a federal employee working with the fda. So I think it's really important to keep an eye on that, that that's really how a lot of these things are held together. What I started to say is the international programs would always have, you know, if you have a plant in France that's inspected by the European and the French authorities as well. So it's not as if, if an FDA person doesn't get there personally, that no one is looking at any of these plants. And a lot of this is again organized by HACCP and people inspecting them according to what their HACCP plans are, these type of things. So there's a lot of inspections going on. But to get the idea that if they're not inspected by a federal employee with the fda, they're not being inspected is kind of like I said, put you on the wrong path about how these things are really regulated.
D
Hmm.
A
It's interesting.
C
Which is not to say that I'm defending the fact that their budgets have been cut, that there's some controversy. It's not that. It's just that there's an awful lot of other moving parts and things to consider when you look at how impactful this may really be.
A
I guess I'm kind of going back to the comment that I made about by heart, which is if there's evidence, whether by anybody. Right. That things aren't going well or that the, you know, they're violations or shortfalls, I'm not finding that there's a technical term for that. But are they using it? Is anybody referencing all of this information? So, you know, there is a lot of information. How are, how are we utilizing this?
C
So what happens for the stuff that.
A
Yeah, the non conformist is. Thank you, Bob. Yeah, yeah, yeah. So do they just say, oh, well, we're addressing. I don't, you know, I don't know. But there are some, some gaping, you know, there are some gaps here, like with Boar's head and now this. You know, it's like, okay, well, is anybody reading the reports that are happening?
C
So, yeah, okay, we got an interview. We get an inspector to come in and tell us exactly how that goes. And one of the things that came up in this report, also exactly what you're talking about, and I don't have notes to be sure about this, but I remember reading through the report, they were talking about the FDA coming back and how often they come back to do the reinspection after they see non conformances. And apparently the report said they were not getting back to those on a regular basis either. So your point is very clear on that particular basis, if the FDA is the one that goes in and does the, the inspection, I believe they're obligated to go back and do the re inspection, but they're not getting to all those either. Was what, what the part of the report I read said.
A
I realize, yeah, I'm mixing metaphors between USDA and FDA with Bohr's head and this. But I think the point is similar, right?
C
Yeah, yeah, that's right.
B
Okay, so we also want to tell you about a first of its kind study by researchers from Wageningen University that shows how listeria strains evolve into strong biofilm formers. So listeria monocytogenes can form biofilms on surfaces like stainless steel, plastic and glass. And this ability is a key factor in the pathogen's survival and contamination potential in food production environments. So the researchers from Wageningen University wanted to better understand the evolutionary mechanisms driving El Mono's biofilm formation ability. Using an experimental evolution model, the researchers isolated evolved variant strains from 2L mono backgrounds, one reference strain and a hypermutator food isolate. The resulting evolved variant strains demonstrated up to a seven fold increase in biofilm production compared to their ancestral counterparts. Phenotypic assays revealed that increased cell surface hydrophobicity was a dominant trait among the various isolates, correlating with stronger attachment to hydrophobic surfaces such as polystyrene and stainless steel steel. Further analysis identified two significantly upregulated proteins as key contributors to the enhanced biofilm phenotype. One protein was found to facilitate stronger attachment of L Mono to surfaces and the other was found to influence cell surface properties and biofilm capacity. So overall, the study marks the first application of experimental evolution to study biofilm enhancement in El Mino. It offers understanding of how certain mutations can drive phenotypic shifts for the pathogen, thereby posing significant threats to food safety. So very interesting study there, I think.
C
Yeah, Listeria is a. It's a sneaky, sneaky strain and tends to show up and then not show up and it causes people headaches. So this may be part of it as far as how they mutate to form biofilms. They're hard to get rid of once they're there.
A
I always get excited when I'm driven to my dictionary. I'm like, hydrophobic, so it's afraid of water. I mean, so I learned. Yeah, it is, yeah. Interesting. I, I don't, you know, clearly don't understand all the implications here, but it is very interesting. So anyway, I guess we'll see what happens here. If anything, that we're learning. All the stuff that we're learning makes food safer than. And especially like you say with these tricky ones, like.
B
Yeah, we've seen a lot of research lately and we've published articles, you know, on the specific topic of listeria within biofilms. So this is obviously a very hot topic and something that is really being studied currently. And certainly with this listeria and listeriosis being such a. Having such a high. Being associated with a high fatality rate, this is a pathogen worthy of much more study. So. So it's encouraging to see so much research pouring into listeria, especially when we're talking about Listeria within biofilms, because we know that those biofilms, once they're forming around that pathogen, they really protect them. And that can be very bad news for a food facility so good that we're studying it more. But before we go today, we want to share an interesting resource with you on AI application and food safety. The Food and Agriculture Organization of the United nations, or the FAO has released a report it jointly developed with Wageningen Food safety Research detailing the need for responsible adoption of AI in food safety fields. Three core areas of AI deployment were identified in the scientific advice, inspection and border control and operational activities of food safety authorities. AI is applied to support the generation of scientific advice, particularly by enhancing laboratory testing, efficiency and cost effectiveness. Research using AI also examines the causes of food contamination and foodborne diseases to inform preventative measures. Predictive models are also helping authorities target monitoring efforts based on environmental and historical data, while AI driven tools are improving food authenticity verification and contaminant detection at borders, and real time analytics and text mining from sources like social media and recall reports are enabling faster responses to emerging threats. So at the same time, the report underscores persistent challenges with data scarcity, capacity constraints and the need for robust governance. Key recommendations for food safety authorities include strengthening AI governance frameworks, building AI literacy and capacity, improving data systems, encouraging multi stakeholder collaboration, and adopting systems and thinking to integrate AI across the food value chain. You can read more about the report's findings and recommendations at the link in our show notes.
A
Well, I guess this is a good time for me to mention that the opening session of our workshops at the Food Safety Summit on Tuesday is Leveraging AI for Food Safety From Strategy to Impact.
B
So that'll be a good one.
A
Yeah, no, that is going to be a good one. Those opening sessions are always fantastic, but clearly anyway, lots to learn there, lots of stuff going on. So very good. Thank you Adrian. And Bob, as always, there are links to all the articles that we've referenced in our show notes. If you don't already, we invite you to follow us on our social channels LinkedIn, Facebook X and Instagram. Just search for Food Safety magazine. And of course, to take a deeper dive into all the great content that Adrian pulls together for us, Visit our website food-safety.com and now it's time for Adrian's interview with Jay Berglund, a nationally respected food safety expert and the principal of Aegis Foods, a consultancy focused on strengthening food safety systems across the supply chain. Aegis Foods is also the maker of Fearless Eggs, the only pasteurized in shell and poached eggs that are safe to eat raw. With over 25 years of experience in food manufacturing, regulatory compliance and quality assurance. Jay is a trusted voice on preventing foodborne illness, understanding federal regulations, and responding to product recalls. Jay has served in leadership roles overseeing food safety and quality programs for major U.S. food manufacturers. His expertise spans USDA and FDA inspection standards, HACCP and third party audit preparation. Through Aegis Foods, he now advises clients on building proactive recall resistant systems that prioritize both consumer health and brand integrity. All right, let's get to that discussion.
B
So today we are doing a deep dive on innovation in egg product safety and the role of consumer trust in food safety. And Jay, I know you have a lot to say on these topics, so welcome to the podcast.
D
It's my pleasure to be here.
B
So, Jay, you have over 25 years of experience in food safety across the food manufacturing supply chain, which has prepared you for not only advising clients in your consulting work now, but also for innovation in food safety science. So can you kind of trace a path for our listeners from the early days of your food career to your work with Aegis Foods and the idea for Fearless Eggs?
D
Sure thing. Yeah, I could go all the way back, but that would be well into the 19th century, so we don't want to go that. But I'll just highlight some of the things I've been doing in the last couple decades, let's say, and sometimes your, your career prepares you for your, your, your end point without you even knowing it. So my, one of my first big jobs in the business was working for a salad company just about the time that people were becoming very sensitized to Listeria. And because it's a refrigerated product and because our manufacturing plant was bringing in things like cabbage and potatoes, we, we became both very sensitized to Listeria. And also it became an issue for us on the marketing and sales side. Having to both understand and communicate that message was really important later on, actually, the subsequent job I had is I was in a startup that was doing cryogenically frozen lobsters, which is a great way of removing any concern about food safety. But it was a technological innovation and very new to the industry. And so when I first got involved with the pasteurized shell shell egg business, it came in really handy. We, in 2004, I joined that company. We had a water bath technology that was able to pasteurize an egg in the shell, killing salmonella inside and out. And without changing the, the quality aspects of the, of the product, it looks and performs just like a regular shell egg. Our team developed the brand and we Grew it from about a million in sales to about 150 million run rate when we sold it in two in 2016.
B
Wow. Okay, so can you walk us through the science behind the pasteurization method that's used for this in shell egg technology and also for the new in shell poached egg product that you're offering?
D
Great, thanks. Yeah. The, the previous method was to take eggs and dunk them in a warm water tank for a period of time. And the idea is, is you're trying to pass enough heat through the, the shell to kill salmonella. And it was an effective message method. When we started to look at this company, however, we knew that the process had to be improved in both quantity and be able to be used for different applications. Aegis technology, our current technology uses a water cascade method that transfers enough heat through to meet FDA standards for pasteurization, but it maintains the appearance again and texture of an ordinary egg. You can't tell the difference if you look at it in other words, and the taste is, we actually think improve because we're going to kill spoilage bacteria inside the egg as well as things like salmonella. Once, once our egg was perfected, we started looking at some other times and temperatures because that's the key in pasteurization, to get different levels of coagulation. And some of these in shell products that we've able develop is a poached egg in the shell. It's used by a couple of large food service chains nationwide already. A soft boiled egg and a jammy egg, which is still in development a little bit. These are all things that a chef can achieve. But the world is. Most of your food is not prepared by chefs. Most of the food in the world is prepared by cooks. And while they have varying levels of skill and ability, having these products allow restaurants and food service to have a more consistent result and for that matter, the home cook to have a more consistent result with, with less training and less, less, less time.
B
Interesting. Is there also a time saving aspect? I'm just curious, like for, for food service businesses with these products.
D
Absolutely. So, you know, for instance, it takes you about six to seven minutes to poach an egg in a, in a, in a food service kitchen. Ours, ours can be warmed up in about three minutes.
B
Oh, wow.
D
Same thing with the soft boiled egg. Yeah.
B
Great. Okay. And you know, we, you talked a little bit about, you know, salmonella, for example, which we know that's a risk in raw unpasteurized eggs. But how does the technology eliminate, you know, hazards like salmonella and also things like avian flu, you know, viruses, but without compromising the taste or the quality or the nutrition of the egg product.
D
So Salmonella is common in birds. It's in the feed, it's in soil, it's in surfaces, and probably for our discussion day, most importantly, it's found inside the hen, including the reproductive track at the hen. This is why any flock, no matter how large or how small, or whether they're being housed in, in a conventional facility or their pasture, raised or free range, can still have Salmonella. In fact, there have been several backyard flock breakouts of salmonella this year. People are concerned about the avian influenza in birds as well. As you just mentioned, it is not mutated so far to be able to pass from eggs to human. But as experience has shown with milk recently, the influence the fluke and jump species. Pasteurization essentially means using heat to destroy bacteria and viruses. Milk and liquid eggs are pasteurized with a very high heat for a very short period of time. Ours is the opposite. It, we are slow and low. So if you're going to use a low temperature, you have to keep the egg warm for a long period of time. So what we do is we use warm water and we constantly cascade the egg over a period of almost an hour with this warm water, rotating it the whole time to make sure that the heat gets evenly distributed and raises the internal temperature of the egg over 128 minutes for over 48 minutes, which is sufficient to achieve the FDA level of 5 log reduction 99.999 destruction of any microorganisms inside the, inside the egg.
B
And so what was the process of working with the FDA to approve and endorse this technology? Like?
D
They are meticulous, the fda, they are scientists. And while most of the science, the time and temperature was already established for pasteurization, our technology is brand new. And so they demanded, as they should, that we, that we prove out with a third party that we were able to hit the standards that they have and that our process would be, would consistently meet those standards. It took some time and they challenged us a lot. But they have a mission for food safety. And so they, they've actually been supportive. They ask really good questions, but they, as I said they wanted they had, we were required to hit their standards.
B
Okay. And you know, thinking about consumer trust, we know that's a huge part of food safety and especially for people who are more vulnerable to contracting a foodborne illness. So how does Aegis Foods and Fearless Eggs commitment to food safety Help build that trust, in your opinion.
D
Fearless Eggs, our retail brand, the mission is to ease the mind of people who are concerned about salmonella. While the incidence of salmonella is relatively low, outbreaks aside, we've had several outbreaks this year. It's about 1 in 10,000 eggs. It's, it's complicated by the fact that there is no sensory way to tell that an egg has salmonella. It looks the same, tastes the same. Unless it's really old, it wouldn't even be developing any changes. Additionally, people in families don't normally consume eggs one at a time and preparation increases the odds. You're going to mix an egg with a bunch of other eggs to make French toast, to make scrambled eggs in baking. And so think of the last time you make cracked an egg. You can get a little bit on your hand and that can cross cross contamination in a kitchen as well. And not just for the consumer, but anybody who handles eggs, including, you know, food service professionals. So we're trying to help people both avoid that if they're concerned about that or if they have health issues or depending upon the people, whether it's be older people, pregnant women or children who are eating the product. Salmonellosis is the infection, the medical condition that happens when a person is exposed to salmonella. Healthy individuals feel bad for a couple days, usually get over it without medical intervention. But as I mentioned, children, seniors, diabetics, pregnant people, people with long Covid people undergoing chemotherapy, their immune systems are compromised and they don't have the strength to fight off the infection. The bacteria then form bacteria then forms colonies and those colonies go on to attack organs and can cause severe illness, hospitalization and the threat of mortality. Under our ages brand we're selling a pasteurized egg to restaurants but to to the consumer and to the people running serving food to to the at risk growth group, we represent both a measure of protection and safety and probably as much as anything else and ease of mind.
B
And you know, speaking of consumer trust, so in light of the recent high profile foodborne illness outbreaks that we've seen and the Trump administration's workforce cuts to the, you know, I think food safety is an increasing concern for both consumers and businesses. And in fact a recent survey by the International Food Information Council of American consumers, confidence in the safety of the US food supply showed that confidence is actually at an all time low. So how do you see the reductions in FDA staffing and leadership affecting the agency's ability to oversee food safety regulations and also to respond to emerging foodborne illness outbreaks?
D
We're very concerned. We have seen the studies that show the consumer confidence that you reference is in food safety is low. Cutting staff and eliminating programs is not going to help that. So I, I am a bit gloomy for the prospects of, of consumer confidence regarding food safety, at least for the short term.
B
And so I guess, you know, going back to Fearless Eggs and Aegis Foods, how would you say that Aegis Foods is playing a role in leading the whole industry towards safer E products and you know, innovation in food safety As.
D
A mission, we feel we have to be at the vanguard of food safety. While there are other companies that produce pasteurized products both in the shell and liquid using the, using the old technologies, no one is really taking the lead in helping the consumer or operator understand their choices, understand the issues or help them to develop best practices or best prevent exposure to salmon unless or for that matter avian influenza. Aegis will evangelize our safety messages as we grow, we'll dedicate more and more resources to the spread of the gospel of safe eggs. One of the things that we have done is we've retained a consultant, someone working on a PhD in food safety who actually works with us on a regular basis and we interface with nutritionists, dietitians and doctors to help, as I said, spread the message and to help their patients or their clients understand what the issues are and to help keep them safe.
B
And actually a couple, I have a couple of follow up questions just about the, the product itself. So for the in shell liquid egg. Well actually for all, for the different, for all the different products that Fearless Eggs is offering, is the shelf life of those comparable to when you just buy unpasteurized eggs? Eggs in the store?
D
That's correct. We, we do put, we are able to put a longer shelf life in because as I mentioned really pretty much at the outset that our process kills spoilage bacteria as much as it kills other microorganisms. So the egg actually retains a higher level of quality longer the, the haw value which is the way the yolk sets up and the, and the flavor has less off flavors as a result. We also wax coat our product which is an innovation that really interesting we helped developed. And what it does is it not only helps the shelf life of the product but it prevents other flavors. Like if an egg is sitting in your refrigerator next to an onion or garlic, sometimes you'll pick up that flavor. You don't have to worry about that with, with the product that's been wax coated.
B
Oh, that's so interesting. I Never actually thought about that. But I guess that's a good point because the shells have some permeation ability, permeability to them. And then I guess, you know, so for example, you know, I know you talked about selling the products to food service establishments, but where can our listeners or consumers find or request Fearless Egg products?
D
So we are in, we're regional at this point. We hope to be national by, by this time next year. We are in the Northeast in shoprite, in King Cullen, in the, in Ohio, we're in Heinen's, in the Chicago market, we're in Caputo's, Pete's, Tony's Waltz. I don't know why it's all names, but in Wisconsin we're in some Piggly Wiggly, some Trigs, some other folks up there in, on the west coast, we're in Gelson's and Save Mart. But we're actually adding retailers every month. And if they want to go on our website, which is eat fearlesseggs.com we have a store locator in which you can find with if there's products, the pasteurized shell eggs in those markets because we just rolled out poached eggs. We're only, only going to be in a couple locations right now, but we're actually having Chicago and California mostly those, those retailers, but that will be expanding fairly quickly as well.
B
Well, great. Thanks for sharing the info about where people can find or request the products and hope to see it in Texas so that I can try some myself.
D
Oh, I'm working on HEB right now, so.
B
Oh, good. Great. That's wonderful. All right. Well, Jay, I want to thank you for this insightful interview. It's been really interesting hearing about the innovation and technology, you know, that you put into this, these safer egg products and then also your views on consumer trust and food safety and, and also, you know, some of the things that are happening at the fda. So I appreciate you taking the time to talk with us. It's very interesting conversation.
D
Thank you. It's been absolutely my pleasure.
A
Thanks again to Jay Berglund for joining us on the podcast today. And as always, thanks to all of you for listening. You know, we love hearing from you, so never hesitate. Send us questions or suggestions to podcastood safety.com or post a note on LinkedIn, X, Facebook or Instagram. We always love getting your feedback. We mean it. We really do. Please send us your notes, text, text us, social, whatever you got. Use it. 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, 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 December 9th. In the meantime, take good care of yourselves and those around you, and we'll talk to you then.
Episode 206: Jay Berglund – In Fearless Pursuit of Safer Eggs and Food Safety Innovation
Release Date: November 25, 2025
Host: Adrienne Blum, Food Safety Magazine
Guest: Jay Berglund, CEO of Aegis Foods
This episode centers on innovations in egg safety, featuring Jay Berglund, CEO of Aegis Foods and architect of Fearless Eggs—the only pasteurized in-shell and poached eggs that are safe to eat raw. The discussion delves into the science and challenges behind pasteurizing eggs, the importance of consumer trust in food safety, and the broader context of regulatory and pathogen challenges in the industry. The episode also touches on current news, notably outbreaks and regulatory trends impacting food safety professionals.
Background & Experience
Egg Pasteurization Innovation
“Fearless Eggs” Brand
In-Shell Pasteurization Science (41:04)
Pathogen Elimination & Food Safety
Why Trust Matters
Brand Commitment
Impact of Regulatory Resource Cuts (49:13)
Leadership in Industry Innovation
On Innovation and Science:
“Most of your food is not prepared by chefs...Having these products allow restaurants and food service to have a more consistent result...with less training and less time.”
—Jay Berglund (41:54)
On Regulatory Cooperation:
“They [FDA] are meticulous...We were required to hit their standards.”
—Jay Berglund (45:35)
On Consumer Risk:
“It’s complicated by the fact there is no sensory way to tell that an egg has salmonella...Preparation increases the odds. You’re going to mix an egg with a bunch of other eggs.”
—Jay Berglund (46:29)
On Industry Leadership:
“Aegis will evangelize our safety messages as we grow, we’ll dedicate more and more resources to the spread of the gospel of safe eggs.”
—Jay Berglund (49:59)
On Trust and FDA Cuts:
“Consumer confidence in food safety is low. Cutting staff and eliminating programs is not going to help that.”
—Jay Berglund (49:13)
Looking to the Future:
“We hope to be national by this time next year...we’re actually adding retailers every month.”
—Jay Berglund (52:08)
The conversation is practical and candid, blending scientific rigor with Jay’s humor and passion (“I could go all the way back, but that would be well into the 19th century…”). The episode maintains a reassuring, expert tone while not shying away from current challenges confronting the industry—from rising consumer anxiety to regulatory shortfalls.
This episode provides a thorough examination of how targeted innovation, rigorous science, and transparent communication can tackle persistent food safety threats, particularly in high-risk products like eggs. Jay Berglund’s approach highlights both the technical and human aspects of building trust—showing that technology, leadership, and consumer education are all essential in the fearless pursuit of safer food.