← Food Safety Matters
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- [00:10]
A
Hello everyone and welcome to Food Safety Matters, the podcast for food safety professionals. I'm Stacey Acheson, publisher of Food Safety magazine, and I'm joined by Adrienne Blum, our editorial director, and Bailey Henderson, our content strategist and editor, who many of you know from our year end review episodes. Bob Ferguson is on vacation this week, so he'll be back. I was gonna say you'll see him but you'll hear him next time. But we've been wanting, we keep talking about it. We talk about it all the time, having Bailey on other episodes other than the year end. So we finally did it. So yay. Welcome, Bailey.
- [00:50]
B
Thanks.
- [00:52]
C
Thanks for letting us pull you away from your PC screen and keyboard for a little bit. Bailey, we know you're constantly typing, so.
- [00:59]
B
Yeah.
- [00:59]
A
Yes. See, that's the typing sound that you hear at the end of the. That's all of us getting back to work. You ever wonder what that sound is? It's all of us going, okay, now back to our day jobs. All right, so Adrienne, do you want to get us started by telling us a little bit about today's interview?
- [01:16]
C
GUEST so in today's interview, exposure scientist and toxicologist Dr. Alex LeBeau explains how contaminant testing, exposure assessment and risk assessment work together and why detecting a substance in food doesn't necessarily necessarily indicate a health risk, with discussions around Florida's testing for arsenic and candy as an example. And we also talk about what regulators and industry need to know to interpret food contaminant findings responsibly. So make sure to tune in.
- [01:45]
A
All right, Excellent as always. So today is a no frills episode. No frills for me anyway, so let's get right to it.
- [01:54]
C
Yeah. Okay. So first up in our news lineup today, infant formula has been in the news more or less constantly lately, it seems like, and new developments are shedding light on the recent infant botulism outbreaks linked to powdered infant formula, which may have significant implications for how the industry detects and manages Clostridium botulinum risk. So first, Bihart has announced the development of a new C. Botulinum specific testing protocol after research commissioned by the company found that the industry's long standing screening approach may not be sufficient for powdered infant formul. The findings stem from a study published in Frontiers in Microbiology where researchers concluded that sulfite reducing clostridia, or SRC enumeration, which has long been recommended by the International Commission on Microbiological Specifications for Foods as a general indicator of spore contamination may not reliably detect the presence of C. Botulinum in powdered infant formula. So according to By Heart, the newly developed protocol is approximately 1000 times more sensitive than SRC enumeration and was created in in collaboration with an independent laboratory. The company said it has already shared the method with FDA and other infant formula manufacturers in an effort to encourage broader adoption across the industry. This research follows FDA's investigation into the 2025 Bihart outbreak, which sickened 48 infants across 17 states before the outbreak was declared over in February of this year. So during that investigation, FDA detected C. Botulinum in a powdered whole milk ingredient and matched isolates recovered from a Dairy Farmer's America processing facility to isolates found in both an affected infant and a finished Bihart formula sample. However, FDA says it still hasn't identified the root cause of contamination or determined exactly how the organism entered the supply chain. Until these outbreaks, C. Botulinum had generally not been considered a hazard reasonably likely to occur in powdered infant formula manufacturing.
- [03:56]
B
Yeah, and that FDA announcement comes as investigators continue examining a second infant botulism outbreak involving NARA Organics Whole Milk Organic Powdered Infant Formula, which has hospitalized four infants in three states. While product testing remains ongoing and no definitive source of contamination has been identified, investigators have uncovered a notable connection between the two outbreaks. According to industry sources who spoke to Food Safety magazine, both By Heart and NARA Organics sourced organic whole milk from Organic west that was spray dried into powdered whole milk at a Dairy Farmers of America facility in Fallon, Nevada during overlapping periods between October 2024 and April 2025. Although NARA had transitioned to a European dairy supplier before the June 2026 outbreak was identified. Formula manufactured with the early with the earlier US Sourced powdered milk remained on the market after details of the bihart outbreak became public. The shared supplier has intensified scrutiny of powdered whole milk as a potential vehicle for C. Botulinum spores. Botulinum spores can survive conventional pasteurization and the spray drying process used to produce milk powder. FDA previously warned the infant formula industry in a 2023 call to action Letter that whole milk powder should be considered a potential source of contamination. But neither FDA regulations nor prevailing industry practices require direct testing for C. Botulinum in powdered infant formula. Instead, manufacturers have generally relied on SRC enumeration as an indirect indicator of spore contamination. The NARA outbreak also raises questions about the effectiveness of that approach. Prior to the recall, the company promoted its use of SRC testing at specifications 10 times more stringent than those recommended by the International Commission on Microbiological Specifications for Foods. But those protocols didn't detect contamination in ingredients, manufacturing processes or finished product before infants became il. Supporting concerns that SRC enumeration alone may not adequately protect against seed botulinum contamination in powdered formula. FDA said there's currently insufficient evidence to conclude that the shared milk supplier or processing facility is a source of contamination in the NARA outbreak. As the investigation remains ongoing, the agency has also confirmed that inspections conducted at the European manufacturing facilities producing NARA formula identified deficiencies, although both manufacturers have submitted corrective action responses that remain under FDA review. So.
- [06:29]
A
Yeah, well, first of all, and you know, all transparency here, we were like checking our notes as we were getting through this story going, is it how many states and how. And because we've just added another illness. Was that right today? It was, it went to four.
- [06:45]
B
Yeah, it was, I think yesterday or today.
- [06:50]
A
The days blend together, but they are blending right now. Yeah, yeah.
- [06:54]
B
FDA also announced that the California Department of Public Health detected Clostridium botulinum in a opened can of formula from one of the sickened babies homes. So that's another important development along with the additional illness.
- [07:14]
A
Well, and when I was, you know, reading all this stuff over the, the, the more sensitive testing really got my attention and. But then it said that then we get to, you know, SRC enumeration alone may not adequately, adequately protect against it. So I feel like, you know, we're. And we're back. Right?
- [07:33]
C
Yeah.
- [07:33]
A
So it makes me wonder where we really are.
- [07:36]
C
I think that what we know still leaves a lot of questions because, you know, we do know that at one point there was that spray dried milk powder at that Fallon, Nevada plant that was spray dried by the Dairy Federation of America and that was supplied to both NARA Organics and by heart. That was a short window of time. But I think it's interesting that originally, I believe the, the, the supplier of the ingredient, which was Organixx, they had supplied FDA with a list of places where that ingredient was sent and they accidentally left off nara. And they told FDA that now as they're investigating this NARA outbreak, But you know, it seems like the transparency along the supply chain is not really great here. And that of course makes, you know, traceback and trace forward as FDA has been employing in this outbreak investigation, it makes it more difficult. And then, you know, knowing that in the NARA outbreak, they're also looking at the facility in Germany that supplied, um, some of the, the ingredients for the powdered infant formula. And they found Some problems at that plant too. So there's multiple, I think, points that where there could be, you know, issues here. Um, and then also I think it's interesting that when we're talking about, you know, with the botulinum being detected in an open can and from a household, Bob is always very quick to say that, like when you have open product from a household that you're testing, that cannot be 100% proof because we know that organisms can get into the environment. And it's interesting because that's actually something that we'll be talking about on the next episode, which is dropping on July 28th. And I'm doing a deep dive on infant formula and, and donor milk safety with Elena Meadow, who's the founder of Leone Health pbc. And in that interview, we're going to focus on the 2026 cereulide contamination crisis as an example. But we're also talking about these outbreaks that we're discussing here with BIHART and nara and also going back to the Abbott outbreak with Cronobacter. So looking at these different organisms and looking at the different contamination pathways and how can formula and milk processors avoid these problems? So that's a really interesting interview. So I definitely recommend you tune in on the 28th for our next episode too.
- [10:13]
A
Yeah. Hopefully get some more the testing thing and having a methodology and knowing that you can have confidence. Right. That's a huge piece for everybody, for manufacturers, suppliers, consumers, knowing that we've gotten to the bottom of these things.
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B
Okay, so next up in news, USDA's Food Safety and Inspection Service has announced a new pilot program that will evaluate alternative approaches to controlling salmonella in raw poultry slaughter and processing estab. The pilot is part of the agency's continued effort to develop science based strategies following the withdrawal of its proposed salmonella regulatory framework in 2025. The voluntary pilot is open to chicken and turkey establishments that are already subject to one or more existing salmonella performance standards. To participate, facilities must either implement salmonella biomapping throughout their operations or include a validated salmonella critical control point in their HACCP plan. One of the primary goals of the pilot is to evaluate a shorter, more responsive moving window for assessing compliance with Salmonel instead of the current 52 week evaluation period. Participating establishments would initially be assessed using a 13 week moving window that could expand to a maximum of 52 weeks. FSIS will also consider requests from participating establishments for alternative carcass microbial sampling frequencies through the agency's Salmonella Initiative program. Facilities participating through the Biomapping option will be required to submit a sampling plan identifying the facility locations where salmonella will be routinely collected and enumerated. Those who are participating through the critical Control point option must demonstrate that their salmonella intervention has been scientifically validated and incorporated into their HACCP systems. Existing biomapping and validated critical Control point programs are also eligible to participate. According to fsis, data collected through the pilot will help the agency evaluate the effectiveness of these control strategies and could inform future regulatory and policy decisions aimed at reducing salmonella illnesses associated with raw poultry products, which is something that's been a big topic of discussion ever since that proposal was withdrawn last year.
- [12:22]
A
Yeah, yeah, so I checked, I drilled down there, four companies right now that are participating in this and I don't, I wondered if they were trying to get to more or if there was, you know, in other things there have been, there was some information that said that they maxed it out at 20, but so I hope that, you know, four facilities is, you know, enough for statistically valid results here. So I guess. Watch this space. Yeah, yeah.
- [12:52]
C
And I mean, since they're also inviting facilities that already do the biomapping or have a validated CCP to participate, you could have those folks who probably already have a pretty good process in place there, along with the folks who are saying, like, okay, we're going to do this new as part of the program participation. And so I think that could yield an interesting mix of data, but it would definitely be good to see more than four facilities joining this effort since we can't really seem to get salmonella in poultry right yet. So, you know, there's some new things happening, new, new, new tries at tackling that and hopefully more of industry will participate so that we could nail down some of the factors that go into this.
- [13:36]
A
Yeah, so I was trying to figure out like, what's the benefit to people, like to open up their doors and say, you know, other than, you know, wanting, you know, just wanting to help, is there anything in it for them? And I guess that's the difference between the 52 and the 13 week window which would help them get product out faster. Is that to understand, did I understand that correctly?
- [13:58]
C
I'm assuming what, that, that's what that means.
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A
Yeah. Yeah.
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C
Okay, so let's, let's turn to Europe now. So in European news, the European Commission has published its 2025 annual report on the Alert and Cooperation Network, providing a snapshot of the year's most significant food safety hazards, emerging trends and multinational incidents across Europe the network processed a record of 10,490 notifications in 2025, which was an 11% increase over the previous year, which reflects both expanded surveillance and continued food safety challenges across global supply chains. So among food products, fruits and vegetables generated the most notifications, with pesticide residues accounting for nearly 60% of reports, particularly for non imported product. Mycotoxins, especially aflatoxins, remain the leading hazard in nuts and seeds, while Salmonella continued to be a major concern in poultry and meat products. The report also highlighted persistent issues involving Listeria in fish and seafood, chemical migration from food contact materials and fraudulent or non compliant food supplements, many of which were sold through online marketplaces. The Commission also reviewed several of the year's most significant international food safety events. One was the multinational Listeria monocytogenes outbreak linked to pasteurized cows and goat milk cheeses produced in France. This outbreak sickened 21 people, resulted in two deaths and led to recalls affecting products distributed under multiple brands in 65 countries. Investigators concluded the contamination most likely occurred during cheese production rather than in the raw milk. Another major incident involved the global recall of ceralide contaminated infant formula, as we'll discuss in that July 28th episode that I teased earlier. So, investigators traced the cereulide contamination to arachidonic oil imported from China and supplied to multiple infant formula manufacturers, which affected 99 countries and territories and led to recalls across more than 60 countries. In addition to new cerilide safety thresholds for infant formula, the incident prompted new EU emergency import controls as well. The report also highlighted the multinational Salmonella strathcona outbreak linked to tomatoes produced in Sicily, which caused more than 400 illnesses across Europe as well as cases UK, Canada and the US environmental sampling ultimately identified the outbreak strain in irrigation water, reinforcing the importance of agricultural water management and fresh produce safety overall. The European Commission said the report underscores the growing importance of international surveillance and rapid information sharing as regulators respond to microbiological and chemical hazards, food fraud and increasingly complex food supply chains.
- [16:44]
A
Well, it is interesting taking a look at what's, you know, Europe as opposed to, you know, what we're so familiar with here in the US One of the things that caught my attention because I guess, you know, I haven't I don't hear about Listeria in fish and seafood a lot. It doesn't seem like something that we cover a lot. So that one kind of popped out at me as different from from some of the trends that we see here. But I'm sure you know, lots to Take a look at and compare and contrast.
- [17:11]
C
So, so one of the things that stood out in the report to me was just a little bit unusual about that outbreak of listeria in cows and goats milk cheeses produced in France. Because the investigation found that the milk was pasteurized and then it was used to make cheese, they found that the contamination most likely occurred during cheese production. So then you've got listeria in the cheese making plant, but it came from pasteurized milk, which you think like, oh, well, pasteurization destroys listeria and it does. But then if you get it into a plant that has, you know, is making cheese and you've got listeria there, then you're going to have a big problem. So, yeah, I mean, we worry, we worry about raw milk here in the United States and, you know, kind of people pushing that and saying, oh, it's healthier and all this stuff. And there's a million reasons that the CDC and the FDA keep throwing at people as to why you should not drink raw milk and eat raw dairy. But in this case, you know, you would think, oh, you're, you're safe because the milk is pasteurized and then the cheese was made for the milk. But, you know, again, two people died and at least 21 people got sick because there was something wrong at the cheese making plant.
- [18:20]
B
The report itself underlined that quote as contamination of cheeses made from pasteurized milk is less common. Such consumption is not discouraged for pregnant women, young children, the elderly, or immunocompromised. So that just makes it the stakes a little bit higher because these populations aren't expecting their pasteurized milk products to get them sick. But yeah, the report also did outline that this contamination can happen during production, even post pasteurization, due to the presence of listeria in the environment. So that's that.
- [18:58]
C
But it sounds like even, even, you know, the report even acknowledges that this is a little bit of a, a freak, unusual thing that happened.
- [19:06]
B
So, yeah, yeah, cool.
- [19:08]
A
And I'm excited about this next one here because it will put an end to some of my ongoing confusions.
- [19:15]
C
All right. Yeah, so, okay, so before we go today, we want to let you know that a new California food labeling law is now in effect and that makes the state the first in the nation to standardize consumer facing date labels on packaged food. So beginning with products manufactured on or after July 1st of this year, companies selling packaged foods in California may only use the phrases best if used by or best if used or frozen by to indicate product quality. And the statements used by or Use by or freeze by to indicate food safety. So consumer facing sell by dates, along with other ambiguous terms like expires on or freshest buy, are now prohibited to reduce confusion and unnecessarily necessary food waste. So, as we said, the law applies to packaged foods manufactured on or after July 1, but it doesn't require manufacturers to add date labels where none previously existed. It also retains California's requirement that refrigerated packaged foods have a shelf life of no more than 30 calendar days from packaging to consumption or the original safety date, whichever comes first. So I think since California represents such a large consumer market, the new labeling requirements will influence packaging practices well beyond the state. Manufacturers are going to have to look at whether they want to adopt the standardized terminology nationwide, which is probably the better course, or if they want to make separate products for the California marketplace, which is a little more complicated.
- [20:44]
A
But, I mean, I don't even know how many times I've done that. Calculate well, sell by. Well, let's see, what does that mean?
- [20:51]
C
I find it confusing too, even as, you know, as a consumer, but as someone who works in this industry and understands more than maybe the average, you know, food consumer would, I still find it confusing when I see, you know, a sell by and then something else. And. Yeah, I don't know.
- [21:07]
A
And the fact that, that they acknowledge that statements like best buy are quality. So I'm glad that they go through and really, you know, point out use by as opposed to best buy.
- [21:18]
C
Yeah, yeah. I want to see. Okay. As a person who is really paranoid about food spoiling, you know, even one day past its quote, unquote expiration date, I want to see used by dates when I see sell by. And especially if it's something that's, you know, prone to spoilage, it can spoil quickly. I like, that makes me nervous because I would be that person who would be contributing to food waste by throwing out food if the, you know, the sell by date, if I feel like, oh, it's one or two days pass, so maybe that means it's not good anymore. And then, you know, it probably was completely fine.
- [21:52]
B
So.
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C
Yeah.
- [21:54]
B
On the other hand, you have me that because I know so much about the cell by used by microbial pathogens and spoilage and stuff, I'll look at the used by. Then I'm like, one day this is probably gonna come back and bite me.
- [22:09]
C
But I won't throw it out till it starts growing mold. Right.
- [22:12]
B
Or like, it'll be like, oh, the milk's still good. Yeah. And then you take a sip and it's not.
- [22:17]
A
It's like, yeah, the smell, if by, you know, can be applied. I find that it works pretty well on lettuce too. It's like arugula takes on a whole other thing. Smell by day when it's this.
- [22:32]
B
I'm interested to see if the rest of the country follows suit though, because as it usually happens, where California goes, everybody else follows. And I've seen on like comments and stuff on the story and social media, mostly supportive probably because our audience is mostly in food safety. But I've only, I've seen only a couple of comments about, oh, the costs for manufacturers and whatnot. But, you know, if California might be just setting a new standard for the country, we'll see.
- [23:02]
A
I mean, they just. It's just a. Well, I imagine there's some cost involved with changing the way they label things, but I mean, anyway, yeah, there's always someone that's got a problem with something. I've come to.
- [23:17]
C
It's certainly not as much, much of a cost as, for example, updating your allergen labeling that that's what you call an expensive, you know, but necessary formulating. Yes, exactly. Yep.
- [23:30]
A
Yeah.
- [23:31]
C
All of which we've been discussing that food. We, we realize and we acknowledge absolutely that food manufacturers have a ton of things being thrown at them right now, especially in the US when, you know, these things are changing so quickly here. So we're absolutely not belittling or, you know, undermining what food manufacturers have to go through. But, you know, I feel like changing the way that you specify what the food quality and safety dates on packaged
- [24:01]
A
doesn't seem to be the heaviest lift that we should.
- [24:03]
C
Yeah, exactly. Yeah, you put it really well.
- [24:05]
A
Yeah, yeah, exactly. Well, thank you both. So, as always, there are links to all the articles that we've referenced in our show notes. And if you don't already, we invite you to follow us on our social channels, curated expertly by our own Bailey Henderson. Those are LinkedIn X, Facebook, Instagram and YouTube. Definitely check out our YouTube channel. We're adding more and more stuff to that all the time. And we've recently started putting up some of our past webinars on there. So that's. That's real helpful. So check it out. Food Safety magazine. Everywhere you get stuff. And to take a deeper dive into all the great content that we offer, Visit our website, food-safety.com and while you're there, register for a free membership. This will give you unlimited access to our website and a free subscription to our Food Safety Digest, our twice weekly newsletter that keeps you up to date on news and food safety magazine feature articles, videos, podcasts and monthly webinars, AKA everything. So do that. And now it's time for Adrienne's interview with Dr. Alex Lebow, owner of Exposure Assessment Consulting in Orlando, Florida, where he offers toxicology, industrial hygiene, risk assessment and public health consulting services. Over his 13 year career, he has evaluated environmental and occupational exposures and has performed toxicological evaluations of chemicals and biological agents. He's also performed human health risk assessments of contaminated sites using U.S. environmental Protection Agency and state regulatory guidelines and has monitored remediation activities at those sites to evaluate the exposure of impacts on building occupants. He's performed indoor environmental quality assessments, including Legionella and water quality assessments at healthcare, residential and industrial facilities. Dr. Lebow has been a co author on industry guidance for COVID 19 issues. He's also been retained as a testifying expert witness and provided consultation on several occupational and environmental exposure claims. Finally, Dr. Lebow has authored safety assessments on consumer products, including antimicrobial pesticide registration dossiers, generally recognizes safer grass determinations for food ingredients following FDA regulations for scientific procedures, and submitted a health claim petition for the FDA that was successfully accepted by the agency. All right, and with absolutely no ado. Here's their discussion.
- [26:41]
C
Well, recent reporting on Florida's arsenic testing in candy has raised questions about how contaminant data are generated, interpreted and communicated to the public. So here with me today is Dr. Alex Lebow, an exposure scientist and toxicologist to examine the scientific context behind these findings and what may be missing from the current discussion. So welcome to the podcast, Alex. It's great to have you here.
- [27:06]
D
I appreciate you having me.
- [27:08]
C
So you have nearly two decades of experience conducting human health risk assessment. So how does that background shape your initial reaction to Florida's reported arsenic findings in confectionery products?
- [27:21]
D
Sure, that's a great question. Let me ask a quick question to you back. Do you have kids?
- [27:26]
C
I don't, but I know, you know, most people do. So they're probably concerned about, I mean,
- [27:31]
D
I'm sure you probably know some parents who probably have kids. And you know, when, when the general public kind of sees this information about something that's in their kids products, whether it's a food product or a toy or something like that, you know, people get upset about it and if they don't have that knowledge, they get reactionary. They say, oh my God, what's going on? And I look at this and I help Shape my thinking and I help shape others as best I can. And say, listen, you know, there's ways that these data can be interpreted. There's processes to go through on risk assessment and understanding what hazards are and what risks are. So that background assists me to understand what, what I mean, I have two kids, what I can all feel I could safely give my kids versus, you know, explaining to other people why I may or may not be concerned about something in a product like arsenic or whatever it may be. You know, I do also, I'll say product safety assessments on other products and I'll say whether, you know, I'm concerned about it or I don't really have concerns based on the data. And it very much comes down to what the data looks like and how to interpret that data from, from as you said, the exposure science standpoint.
- [28:47]
C
And you know, in reviewing the healthy Florida first data that's been highlighted in this recent coverage, what specific gaps in like testing methodology or data reporting or transparency do you think make the findings kind of difficult to interpret from a scientific standpoint?
- [29:07]
D
When this first I'll say came out in January and February this year, there were, were a lot of unknowns. It was seemed like a media blitz on looking at kind of sensationalization of data and saying, look what we found, you know, and, and making this like, I want to say a bigger deal than it is, but a big deal without context. And you know, there's, there's been some, I'll say, updates on information that the Florida Department of Health has released, but overall there's lots of missing information. You know, when I look at doing assessments, I want to understand the entire process from selection of the material through the risk assessment process. I don't know how these materials were selected. You know, the Florida Department of Health says something to the effect of, you know, these products now recently said this from. They get them from multiple retailers and online locations to get different manufacturing batches and lot numbers. That information was released initially with, you know, how many samples did they run? I don't know how many that, you know, there's a data gap there. The data and reporting. I don't know what the data is looks like from the lab report. If it's, if it's easy data. They say that they're following laboratory standards. Great. Release the lab reports. Let us see it. Let other people who are used to this just see the data itself. Even layman can let me look at it. And because there's usually a summary in there. So the transparency make it difficult from the data reporting side and the methodology, what equations did you use? What inputs did you use? Again, the frequently asked questions that they have recently put out kind of generally touch on subjects, but they still don't give the basic information requirements for understanding how the assessments were done, who decided what inputs to use, how those inputs were applied, and how different input parameters may change the outcome. Sometimes in science we refer to as this as a sensitivity analysis. If we use these inputs, we may get this output X, but if we use these other inputs, we'll get output Y. Why are there differences? What do the differences look like? And is the actual number somewhere in the middle between X and. Yeah.
- [31:24]
C
Interesting. And, you know, looking at this from a toxicology perspective, how is arsenic typically evaluated in food and consumer products? And, you know, what kind of context is necessary to determine whether detected levels are even meaningful for human health?
- [31:41]
D
You know, there are a variety of methods that are out there. And what you would like a laboratory to do is typically start a basis using a standard method that's been approved by, I'll say by a regulatory agency, by FDA or EPA or someone. And labs are known, and they can do this following their internal standards and procedures and auditing requirements are following, or they may be modifying those methods to better fit the scenarios. So if you look at the laboratory, they say we run, I'll just say say FDA method or whatever method is, but they'll say a modified method. And if they, if they have some kind of modification to a method, they'll explain the rationale, they'll explain how they get this. You can backtrack and saying, okay, that makes sense why they did that. Maybe they've run into issues with, I'll say, what we call a matrix. And before we say, well, we can't analyze that matrix using this method, we've modified it so we can do that. And there's lots of things laboratory. I don't have a lab. I've worked in labs. But they use standards and they run standards and they compare them to curves and they'll do something called spiking the material, saying, we'll put it in a known concentration to see if we can recover that concentration within this tolerance level. And it all depends on what the intended use is of that material. For example, if you're looking at a food product, there are, I'll say, food analytical methods that are out there for looking at my, maybe heavy metals that are in foods. Finding out what the Florida Department of Health did was very difficult. You know, they, I, when I was searching this up there was a quote and a news story from someone that, that purportedly was from the Florida Department of Health FDOH and said, well we use this EPA method. And on their FAQs they say oh yes, this test follow us EPA methods. Well, if you look at the EPA method and the one that they are quoted and News is using is for soil matrices. So it's not a food source. It's for something that's an environmental source. So I, I think it all depends on what you're using the material for and how you're using the data. For example, if I'm going to use a product, do something for product safety assessments and your, your listeners may or may not be aware of this. You know, certain, certain regulatory agents, agencies require things for. I'll say if it's a medical device or something implanted in your body, there's standards, there's ISO standards that you have to all say follow. But they're also, and I've worked with some of these, there are brands that if you're selling something associated with the brand identity, they have their own set of safety parameters that you have to follow on understanding. Let's just say it's, and I'm just throwing random things out there, it's a phone case. And you want to make sure that if you're holding your phone case all day, which way too many of us probably do, that nothing is coming out of that phone case that could get onto your hands. So they do these studies to determine whether or not soaking the phone case in something that's going to mimic sweat may release anything from that material onto your hand. And there's methods and ways to do that. So it's applicable to the scenario that is, is, is being evaluated. So if they're using potentially an EPA method for environmental, I'll say soil matrix to apply to food, that makes maybe interpreting the data more difficult because I mean there, there are certain issues or diseases that are, are the people want to eat dirt? That's a whole nother story and scenario. But is it is are you getting the data that you need based on the method that's being used? And there's probably better methods that are out there to use. But again, if there is a modification to the laboratory that said, hey, we had to use this method because the most sensitive methods, the one that helps us get the best resolution, understanding it based on the digestion of the material or whatever it is, then it should be explained in the report, should be explained in an audit. And the fact that this information is not released makes me, I don't want to say suspect of the data, but it makes me very much want to question what those data actually mean.
- [35:53]
C
Yeah, absolutely. Now you've emphasized that detection alone doesn't equate to danger. Now can you walk us through the difference between hazard identification and risk assessment and why that distinction is so critical in this case?
- [36:10]
D
I'll take this a step further and back. And this is always a difficult, I'll say challenging conversation to have because when people hear hazards, they hear risks. And they tend to use them synonymously, saying, oh, they're interchangeable when they're actually not. So hazard is generally a theoretical kind of idea that something could be harmful at any amount. So I think it's important to remember, and this is important context, is something hazardous, they say hazardous material, where many things can be hazardous. And I'll explain that a little more in a second. When you think of risk, risk is the amount of, I'll say quantifying the amount of hazard associated with something based on a lot more, I'll say parameters, exposure parameters, what we refer to as dose, the amount that gets into your body, how it interacts with the body. There's lots of things. So when you think of hazards and doses, dose or risk assessment, risk, everybody says, oh, well, things are hazardous, you know, but people don't realize that if you, if you know, water is something that's essential for life, it can be. Water could be hazardous. You can actually take in too much water in a 24 hour period and essentially drown yourself by drinking it. So it's important to recognize that just because something is a hazard doesn't mean it's an actual, what we call human health screen. Risk, risk driver. Say that, you know, just because it's detecting something doesn't mean that our bodies can't handle it like water. Our, our bodies require water. If we have too much water, we visit the bathroom too often. If we have way too much water, then that obviously ends up a problem. But it's like, like this scenario of arsenic. Our bodies can handle a certain amount of exposure to lots of things in arsenic. Here, here. Our bodies know how to deal with it. We know how to eliminate. The whole point of getting something in our body is our body wants to get it out when it's not supposed to be there. So it's important to realize that when you're assessing risk from, again from the arsenic or whatever it is, there's lots of parameters that go into beyond just saying something is a hazard. You need to understand if the actual risk or risk driver. And that's an important distinction that a lot of people don't seem to want to explain. Well, from the, from the public health perspective. And the person that's a parent is going to say, what does that matter to me? So having the explanation to think is always crucial.
- [38:40]
C
Yeah, I think, you know, the context is really important here and certainly the communication about risk is so important. Now, looking at, you know, this example of arsenic in candy, what types of exposure assumptions and risk calculations are normally required to translate, you know, the results you get from contaminant testing into a realistic assessment of consumer risk?
- [39:05]
D
When you're, there's. There's lots of different equations out there. So we, what we do is we do modeling. We say, okay, we. These are modeled parameters on lots of different, I'll say, some assumptions, they could be, you know, as long as they have validation behind the assumptions, they go into these model parameters and then we can model what. What are our risks are. So we look at a few things. So as I mentioned before, and this is going to be crucial and probably discussions further is there's four main parts to a risk assessment. So hazard identification. We've already talked about identifying a hazard. The next two are exposure assessment and toxicological or dose response assessment. So when you're looking at evaluating this, you want to know what the exposure parameters are. Are you want to say, okay, well, if you think about water, you know, when you're doing risk assessments, there are. There's generally, and this is, I'll say it's beyond just the environmental exposure. There's a document that EPA puts out, it's called the Exposure Factors Handbook. And it talks about how people are exposed, what they are exposed to, as far as, I'll say, intake parameters. So one of them is discussing, you know, intake of water per day. So generally they have all these studies and they summarize them and they say, listen, you know, individuals take in, I'll just put it out there, an average of 2 liters a day of water. Now, it's important that there's a distinction there because it's two liters a day for everybody. Or is it two liters a day for certain populations? And if you look at it, we'll say, well, adults probably take in a higher volume of water than kids. So you want to understand, okay, well, are the exposure parameters they're evaluating, did they use a general, adult and kid kind of average. Did they use the adult value or did they use the kid value for Water intake or whatever intake you're concerned with. What weight did they use in their parameters? Because usually it's a. When you look at something as far as dose, it's usually a concentration milligram per kilogram body weight. So, so arsenic in the milligrams and body weight in the kilogram. So did they use an adult, did they weight, do they use a teen weight, did they use a child weight? All these parameters go into understanding what the exposures potentially could have been and the fact that those are not being reported anywhere other than again, and I point out to the Florida Department of Health having these frequently asked questions they recently put out. They just said, you know, how is the risk evaluated? They just randomly just mentioned epa, efsa, European Food Safety Authority, ATSDR and other default exposure factors. But that doesn't help me understand what their inputs were in their equations. So not having that information is difficult to translate into a risk. Because as someone who does this, I want to see what your inputs were because sometimes they're open for discussion. You can say, well, it doesn't make sense that you're using that one. Let's discuss why and support why. Whenever I'm doing a risk assessment, I say I use this value because it made sense for the scenario that I was evaluating as opposed to, well, these are just the default ones we figured out and fall back to, but I don't even know which default ones they used.
- [42:31]
C
And you know, speaking of how the federal agency, these typically structure exposure science and toxic toxicological risk assessments for contaminants in food, you know, how, how do they do that, like the fda, the epa, and how does that compare then to what's been shared in this case?
- [42:50]
D
Sure. And you know, as I was alluding to, you know, when you, if I'm doing a risk assessment for all, you know, a state agency or a federal agency, they want to see everything explained now. They want to see, you know, what all my inputs were, why I chose them. And interestingly enough, and I don't think this has changed recently, but you know, if you're looking at FDA, FDA may say, okay, we're going to assume an individual 60 kilograms, whereas the EPA is going to say we're going to assume an individual adult is 80kg. That could have an impact on what the risk is. So which risk level did they use? You know, all that is typically explained very plainly when these, I'll say if you have to submit a risk assessment for an environmental cause or if you're doing something, there's Some stuff that you do for FDA from the food side, from the CFSAN side is, you know, if you're doing a generally recognized, a safe or grass determination or for you using, you know, a food additive petition or something, you know, that stuff is explained in there. This is what we did. This is what our assumptions were, this is our toxicological basis for we chose this threshold. And the fact that again that it's. This FAQ from Florida Department of Health is a page and a half. You know, if you've seen grass notifications, if you've seen these submissions for food added petitions, they're 100 pages long. If you look at risk assessments for EPA, they could be 100, 200, 500 pages long, depending on how many sites there are, what data evaluation they did. The fact that this is not released and not available, just, just, you know, it, it pales in comparison to what's typically done. And again, it's, it should be easy for them to release this. And I don't know why they have it, but they just, you know, they're, they're, they're very hush hush, which always makes me, when someone's hush hush with the data always makes me go, why?
- [44:41]
C
So, yeah, it's, it's definitely an interesting question now, you know, kind of looking at this issue and the concerns that we're raising in this interview. So in your view, how can incomplete or selectively presented data unintentionally distort public understanding or elevate concerns, particularly when it involves contaminants like heavy metals and foods?
- [45:05]
D
You know, and again, this goes back to the laboratory question is, what was done at the lab? How did they, you know, how did they evaluate that? So, for example, one portion of what I do is I'm like, I'm adjunct faculty at the University of South Florida College of Public Health. So we've got some research going on using some secondary data from nhanes, which many of your readers may or may, or listeners may or may not be aware, is the National Health and Nutrition Examination Survey. We're looking at arsenic data and childhood, I'll say, growth outcomes to see if there are any associations or not with any of those. But when you look at that data from nhanes, you know, and this is important context is, you know, non detect from the laboratory doesn't mean non, detective. Non detect from a laboratory means that based on their internal, internal standards and internal requirements, they just couldn't detect it at the levels they have set. Typically, people refer to these as the reporting limit or A limit of detection or limit of quantification. And all those have slightly different meanings. You know, if I look at NHANES data, they report and they say, listen, we report this data as, you know, the limit of detection divided by the square root of 2, which is kind of a standard methodology for saying, listen, we're going to say that there is some amount there, we just can't see it. But we're air on the side of caution to say, listen, when you're evaluating this data, this is how you need to evaluate it and show that, you know, even though it was not detect, we're assuming that there's a small amount in there. I don't see the state of Florida did this. You know, they, they just say, and their data is to say it's non detect. I don't know what non detect means. Non, non detective tech can even vary between laboratories. So you know, I don't know if the lab that they use, they talk about the standards and ISO standards, which is kind of a traceability requirement. I don't know if they use the same laboratory. There can be intra laboratory or inter laboratory variations and say their limit of detection may be higher than another laboratory where all the samples done at the same lab at the same time. They sent different places, different reporting limits. So, so, you know, when, when you look at those things and then say, well why isn't that available for me to look at? It's, it makes me question it and it kind of distorts things. It says, well, you know, I don't know what those levels actually mean. Is that actually non detective? Conversely, for the detections, it goes back to the discussion. What did the data actually mean? Did they, you know, how did they evaluate the sample? Did they, you know, that they, let's just say it's a little piece of candy or whatever it is a skittle or whatever. I say skittle, generally just a small little circle candy. You know, did they look at one skittle? Did they put the whole pack in there and homogenize it? They mix it all together. Did that. Was it based on one piece of candy with the whole bag, A few samples from the bag? We have no idea. And that kind of distorts things also. You're like, you know, when they say, oh, you should limit your, your, your ingestion of these. And I'm, I'm trying to look at it right now, you know, and limit your ingestion of candy or this particular candy to you know, three bags a year, 16 pieces. Oh, they're Looking at gummies and stuff, you know, but what does that mean? Was that again, based on a per piece? Did they look at multiple pieces from multiple bags? It just, it almost biases. What, without the context, it biases what they're reporting. So then people say, well, what does it mean? Because in the important context here, arsenic is found naturally in nature. It's, it's everywhere. And there are food products. You know, if you think about there, there's, there's FDA regulations or at least notifications for having rice. If you're talking about, I'll say root vegetables or something that's grown in soil, it could uptake anything from the soil, including arsenic. So, you know, it used to be, and I don't know if this is much now, you know, sweet potatoes used to have a high amount of arsenic, right? Rice has a high amount of arsenic. You know, the apples could as well. So, you know, there, there are, it's not unique to candy having arsenic in there or anything, which is why, you know, there's, there's obviously a push to want to analyze the food products. And also importantly, and I, I bring this up also is, you know, often food manufacturers have internal standards or I'll say specifications that they have to, that have to, they follow and say, listen, we're going to analyze our own products and we're going to, you know, set our tolerances at these levels based on our own risk assessments. There's no indication that, you know, the Florida DoH reached out to any of these manufacturers and said, hey, what are your internal tolerances? How do our numbers compare to yours? You know, it doesn't. You know, it gives a distorted view because, you know, and typically the, the manufacturer's information is not released. It's more so for their internal standards. But, you know, if that data, if the, if the manufacturer's data is an order of magnitude or two orders of magnitude, you know, 10 times or 100 times lower than what the FDOH is saying. I think that information is important to get out there and get ahead of because somebody's going to go, why are there such vast differences? And I think that that will help with the public's view of what these numbers may mean in context.
- [50:28]
C
Now, you know, given that context is so important when we talk about this, and you need those specific data points to understand the context. What do you think are some best practices that regulators and public health authorities should be following when they're communicating things like contaminant testing results and, you know, with the view that that information is accurate and transparent and also responsibly interpreted by both the industry and consumers.
- [50:57]
D
Yeah, and I'm gonna, I'm a challenge you and your listeners a little bit because I want, you know, I always, I always love feedback. I, you know, they're good or bad. Give me feedback. I'd love to hear from your listeners and they can reach out to you or me or. I don't care, you know, tell me what you want to know. Tell me what will help you understand when data like this come out. Because there are, I'll say, guidance documents for how you, how agencies should deal with risk communication. Risk communication is super important because if you're not communicating your risk efficiently and effectively, then why are you even communicating in the first place? You know, when you want someone to distill this down to the. I want to say the simplest terms with the terms that are most easily digestible. You know, I want to know what people want to know. Do they want to know is it safe? For me, it's some kind. That may be a dichotomous yes or no. That may be. Give me more details than I need to know so I can make my own informed decision. Because people may make their own risk assessment. They say, listen, I'm not, you know, going out in a huge science route of doing these equations. I want to know what, you know, inputs are out there for me to make my own choices. Pretty much.
- [52:10]
C
Much.
- [52:11]
D
And I think that the information that Florida Department of Health, I think it's a, it's a good goal to do, but if you're not releasing all the information out there for effectively communicating any kind of contaminants that for people to make their own decisions, then you're not doing anyone a service. You know, if, if I am going to, and again, I mentioned this earlier. If, if I'm going to do assessments, you're going to know every decision why I made that decision. And, you know, sometimes again I said, well, based on this input, will you use this? Or based on this one, we'll use the other one based on site parameters, you know, intake may vary between different regions of the, of the, of the United States where, you know, I've, I've seen those, those maps of, you know, favorite sodas or favorite candies or whatever in different states. And you may say, well, that's not, not applicable here. We use more of this one or we sell more of this one. So, you know, there are effective risk communication tools that are out there, and a lot of agencies do follow them. But when they don't follow them. And I think that what we're doing here is appropriate, is held holding them accountable on why they're not following them and what they need to do to follow them and hopefully get that data released for future information. Because if I'm sure even people in industry going, what are these, what are they talking about with these data? It doesn't make any sense. Especially as I mentioned earlier, if they go to look at their own internal data, it looks nothing like it. It makes, it's like comparing apples to oranges. They use different methods that they didn't do it in a, I'll say sample in a normal manner. It makes the data almost uninterpretable. So when you're looking at things from transparency and responsibility, you have to understand that, that not only is getting that data point out there the responsible thing, but explaining what it means in an effective communication is also vital to the end user.
- [54:11]
C
Yeah, absolutely. And along with that, I think communication, knowing which audience you're speaking to. Because if you're talking directly to industry versus consumers, like industry, they can take the science and the more data, but consumers need it distilled down a little bit. What does it mean for you? What does it mean when you're standing at the grocery store trying to decide what to buy and if something is, is okay to give to your kids? Right, right.
- [54:35]
D
That's exactly it. You know, I'll have people reaching out to me and be like, oh, are, are, are you still letting your kids have this? I was like, I'm not concerned because I don't see that the data are there to concern me because I don't know what these data mean.
- [54:48]
C
Right.
- [54:48]
D
You know, maybe there is some validity to it, except explain it, tell me why it's valid, you know, go through it. Like you said in industry. Sure. You're going to be talking to people who do this all the time. You know, these industry folks are going to be able to say, and I'm sure they have, and I think I've seen some articles that say, what do these data mean? But when you're making the decision in the store whether you should buy, you know, a hard sweet candy versus chocolate, be like, well, you know, Florida Department of Health says I shouldn't have this or my kids shouldn't have this, that. And you know, are you going to leave a crying kid in the store because they're letting them have something from data that makes no sense? So yeah, I mean it's, it does have to be distilled down but still, you have to understand that you have to talk to people so they, so they understand it. You know, don't talk. And I, and I hate to say this, don't talk down to people. Talk to them on, on in a way that they're going to understand it, whether it's using an analogy or something else that's going to help them, I'll say, absorb that information. So you're not talking over their head.
- [55:50]
C
Absolutely. I want to thank you, Alex, for being on the podcast today. This discussion has been really interesting and I think, you know, it will be interesting to see if there's any more clarification on this data that has been released, if Florida will come out with, you know, a little bit more context or background for, for the methods that they used in this case looking at arsenic and. And candy. So thanks for shedding some light on this issue. I think this is really valuable information for our listeners to have.
- [56:17]
D
Sure, I'm happy to help and I appreciate you having me on.
- [56:20]
A
Thanks again to Dr. Alex Lebow for joining us on the podcast today. And of course, thanks to all of you for listening. Now, you know, we love hearing from you, so please don't hesitate to send us any questions or suggestions to podcastood-safety.com or post a note on LinkedIn, X, Facebook or Instagram. We're always happy 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. Two hundred and many, many, many. Right. 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 July 28th. In the meantime, take good care of yourselves and those around you, and we'll talk to you then.