Addressing PFAS in Consumer Products: Challenges in Risk Assessment for Apple Watchbands

Dr. Alex LeBeau is an esteemed exposure scientist and the insightful host of the "Exposure Scientist Podcast," where he addresses listeners' concerns about everyday hazards and their potential impacts on health. With a commitment to educating the public, Dr. LeBeau navigates the complex world of environmental exposures, helping audiences understand and manage the risks they face daily. Although the podcast offers valuable information, Dr. LeBeau emphasizes that it is not a substitute for professional advice and encourages individuals to seek personalized consultation with an exposure scientist for specific scenarios. Through his engaging podcast, Dr. LeBeau continues to empower people with knowledge about the unseen hazards around them.

Contact Dr. Alex LeBeau at Exposure Consulting for exposure litigation support or Exposure Science Consulting.

Transcript

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You might not realize it, but we are exposed to dozens of hazards every day. Can any of these hazards negatively impact your health? Definitely. This is the Exposure Scientist Podcast. My name is Alex Labeaux, and here, we answer your questions and concerns on what you may be exposed to every day. Welcome to the Exposure Scientist Podcast. The views expressed in this podcast may not be those of the host or management. This podcast is for informational purposes only and should not be considered health advice. It is recommended that you consult an exposure scientist to discuss the particulars of your exposure scenario. Hello, and welcome to today's episode of the Exposure Scientist podcast. One item that has been in the news recently that you may have seen is this concern of PFAS in some consumer products. Namely, these are stories that are involving, PFAS and Apple watch bands. What's interesting about this is the assessment that was done and new stories that were done, and I'm looking at some of the articles now, and you can go search them up and find them. It says they're, you know, they're forever chemicals that were found in these bands. Some of them have specific names that they're found in as far as the type of band it was in, and there have been lawsuits that have been filed against, the manufacturers for the presence of these PFAS. So I have clients that are dealing with consumer product safety assessments and evaluations, And I've had to give them some additional warning on the potential of these higher scrutiny of PFAS and their products. We're already doing those assessments, or are they setting them up for success? But it's important to understand that, you know, there's gonna be additional scrutiny. So we may have to do some additional steps to make sure that they are covered in the event that someone does come and and and randomly grabs the samples, sends them off to a laboratory for analysis, and identifies PFAS. Now, there's lots of issues here with this assessment. What is the first issue? Well, as I pointed out, and this is an article on Popular Science, it says that there are no established guidance on the safe level of PFAS exposure. Okay. Well, and that that's that's, I'll I'll say, relevant from a consumer product standpoint. But more specifically, depending on the type of consumer product it is, there may not be specific prescriptive guidance for that particular product. A lot of the guidance that we like to use when we're doing assessments of any types from a toxicological or other type of assessment is we look at studies that are standardized that we can easily reproduce if we need to. We know the methods. We knew the methodology. The studies have been validated. We go to a laboratory that is, that has experience with these, and we say, okay. Perform these tests per guidance, whether it's EPA or FDA, or OECD or whatever guidance, that's irrelevant. So we know that the results, the positive, negatives, everything's set up, but it's it's a reproducible the intent is have it to be a reproducible test. There are a lacking of specific guidance for some consumer products, namely ones that are gonna be identified as wearable. So what we do from a toxicology standpoint is we use other guidance that are available for other more, I'll say, restrictive products, whether it be medical devices or some other type of device that's gonna be in a a long indirect or direct contact with the body for a prolonged period. And that's important when I say contact with the body for a prolonged period to do these assessments. Now what do the data tell us from these, stories that is out there? This is kind of a thought of, well, is it being evaluated in a way that is going to mimic normal use conditions? Okay. Well, what are normal use conditions? Well, wearing a wash band. I've got an Apple wash band on now. It's a metal one, but I've got one on right now. So are are is is the condition going to be prolonged contact with the skin under a wash band, or is it going to be hazard spotting? Are you going to be saying, well, it's in there. It must be coming out at some point. Well, what was the methodology that was used? That's that's always the next question I have. And and and I I repeat this whenever I can to anyone. I'll say anyone who will listen. But when you're reading news stories or articles and then do this as often as you can. If it's available now we're talking older studies. It's not. But if you're reading a news story or article and they say, oh, well, this study says this. Go get the study. Read the study. Understand what's in the study because a study is where the information is. And I I know people who are interpreting these studies that may not have the experience and do their best, but they don't always get it right or they're missing information or or context here. So, you know, what did I do? I went to go get the study. The study discusses the presence of, PFAS, and watch bands. But what's interesting within the study itself and, again, you can go get it. It's, it's environmental sciences and toxic and technology letters, is the methodology that they use. The question should be, what is the biological relevance of the presence of PFAS and the extractability or leachability and the bioavailability of the material when it's coming out of the band, potentially, and impacting the skin, potentially? Is there any dermal absorption going on? How well do the individual PFAS that they're looking at across the skin barrier or absorbed into the body? What is the what is the mechanism for absorption and distribution and excretion of these materials if it actually is? And I find it interesting. So with if you go to the study itself, it references it says, you know, I'm gonna paraphrase here. I'm paraphrasing everything. Generally, again, I recommend you go get the studies. It says the target analysis method using the analytes described here were described elsewhere. The methodology described elsewhere. Okay. Cool. Great. What are the methodologies? What are the ways that were they were done? And you go to these the study that's that it's referencing, and it's it's, interestingly, it's referencing FDA. I'll I'll say references in general here, but it's involving, for lack of better, terminology, it's it's referencing guidance for food contact surfaces. It's, hey, you know what? These are these are, I'll say, plastic storage containers that food are gonna contact. What is the leachability of out of this? What can be extracted out of these that may be in food and then that you may ingest. Well, that's a different route of exposure than the dermal route. Exposure science covers a broad subject area, including toxicology, industrial hygiene, and risk assessment. From occupational, community, or environmental exposure, exposure scientists apply scientific methodologies to understand exposure risks and apply controls when necessary. We at Exposure Assessment Consulting have this expertise. Please reach out to us at info@exposureconsulting.com for a free fifteen minute consultation to discuss the specifics of your exposure scenario. When you're looking at the standardized methodologies that we use for other I'll say guidance for other devices when we're looking at consumer products, they're they're very stringent. But they are very set in their ways for what may be extractable or leachable from a chemical analysis. And you say, okay. What is going to mimic human sweat? That's what we're really concerned with, something that's going to touch the dermal surface and what may leach out of it during the dermal extraction. The materials that were used, at least in this study from what I'm preliminarily seeing, are, I'll say, more aggressive than it would be for the anything that may simulate a human sweat environment. So you may be getting PFAS out of something, but what does it mean? Everything has to be taken in the context. So if you're looking at these studies and, again, I recommend you go pull them up if you can. I'm happy to have a conversation with you about them too. Is go look at the studies, see what methods were used. Are they applicable to the exposure route that you're concerned with? Because what I'm seeing here is there's a disconnect between finding the actual material and linking it to an actual human health risk outcome. Because there's differences in the route of exposure. There's differences in the way that it may become bioavailable from the route of exposure. And what is the potential absorption of the material, and what risk does it present? You know, a lot of the context here is missing the risk. Is it, are you looking for a hazard, something that may be hazardous at some study? And I'm I'm I'm talking about generally beyond PFAS. Some study says may be hazardous. Okay. Well, now we've you know, I always like to say there there's a difference between and we all know this that are listening or most of us. There's a difference between hazard and risk. Hazard is potential for something to cause harm. Risk is the actual quantification and a a a a a dose assessment kind of scenario that is going to incorporate actual real world use conditions. The conditions that are here, at least, again, from what I'm seeing, I have it all read, and I again, I mentioned earlier that there's a lawsuit's been filed. I haven't read that. I'm a scientist. I read the actual, you know, studies. I'm looking at the studies, and I I think that there are data gaps that exist between what's been done, at least in terms of these consumer products like Apple Watches that are named here. And, you know, let me go see. I just wanna quickly look at this study. You know, they have a picture, of what appears to be an Apple watch. I'm just gonna actually see recall and see if it it does not actually mention Apple here. And I think that's, you know, some important context. But they just wanna make sure that they're, I'll say, covering themselves to a degree. This is what all the stories are saying that it's Apple Watches. It's important to understand that there are ways to do things that are from a non research methodology that are important for understanding risk and real world conditions. That's great. You know, if if there is PFAS here and it's there and it's being extracted under this method, that's probably a way that we say, okay. Maybe we should find a way to engineer it out or or whatever it may be. Is it necessary to do because they are maybe looking at it from a different angle or way? That is something to for up for a scientific discussion because if they're misapplying the interpretation of the data from a hazard to a risk without going through the steps, then there may be an issue. So, again, if you're involving any cons customers like myself who have consumer products or putting consumer products out to market, and they are doing assessments, either driven, for other regulatory purposes or, sometimes it's even brand ambassador purposes to be associated with the brand. Some of them require steps to go through from a biocompatibility safety aspect. Is this something that and a lot of these have already you know, they already focus on PFAS. Is there something that needs to be drilled down more here, Or is there something we need to get ahead of and say, listen. You know, we do things this way because this is what's commonly accepted in industry. If there are data generated that are not following these methodologies, they don't really apply because there's been no risk assessment actually done. This is just something for you to think about, to view when you're seeing this information, seeing these studies. And I like to just hammer this home because, you know, if you're seeing articles on this stuff, go pull up the actual journal publications and find out what it really says. And if there are people who are contacting you from, news organizations for help and interpretation, help them out because we're the scientists. And a lot of people that are in the, publication, section or realm may not understand the nuances in some of the stuff we do. I hope you enjoyed today's episode of the exposure scientist podcast. I hope it was informative and educational. If you have any comments, you have any questions, or you'd like to discuss this more, please feel free to reach out. I'd be happy to talk to you with it. Hope to see you again soon. Take care. Thank you for listening to the Exposure Scientist podcast. You can connect with us at our website, exposureconsulting.com, where you can book a private consultation and send in any questions regarding any episodes or our guests. See you on the next episode.