 Good morning everyone and welcome to this public meeting of the United States Consumer Product Safety Commission We have one item on the agenda this morning a public briefing on the subject of wearable technologies Today staff will present their preliminary research into wearable technologies This emerging product area includes products ranging from fitness trackers to smart textiles and brain computer interfaces and carries a similarly wide range of potential hazards Staff activity in the FY 20 operating plan includes a newly added active voluntary standard in this area and a Milestone report on safety issue with these products. We'll start with the staff's Presentation followed by rounds of questions by the commissioners. I'll call on each commissioner in order of seniority We'll start with five-minute rounds, but aim to be flexible and we'll go as many rounds as needed Today we're going to hear from Dr. Trey Thomas Program area risk manager for chemicals nanotechnology and emerging materials. I want to see your business card And he is joined by Dwayne Boniface assistant executive director for hazard reduction and analysis Thank you so much for being here this morning and you may now begin your presentation Well, thank you to the commission and I appreciate this opportunity to talk about a very Exciting technology so that the title of our talk today is wearable technology overview of products potential hazards and risks and we will talk about wearable technology and What the the team within CPSC has been doing to address the potential hazards? When we talk about wearable technology I think first we can start with just a basic understanding of where we are as far as Consumer products. This is a very exciting time for us We're seeing Significant changes in consumer products. You've heard for example that we can now print out products through 3d printing We have new and emerging materials such as nanomaterials that can be incorporated in the products And we also can see the evolution of electronics if we recall in past decades Most of our electronic devices were remote from us We have the even the radio back in the 1930s and 40s was in the somewhere in the living room the television Even computers were large and in rooms and now we're seeing that they are becoming smaller and more intimate to us So we have laptops and tablets. We have Devices such as our cell phones and other devices that we'll talk about today that are literally worn on or in the body So again, this is a very exciting time, but also challenging in terms of understanding these new technologies and the potential implications of them So today we'll we'll again talk about wearable technology We'll discuss what the staff is doing as far as categorization and hazard identification We'll focus on jurisdiction and the next steps So first what is wearable technology? There are a number of definitions in in the electronic sphere, but one Definition would be technology that is worn on the human body. So basically it's technology or electronics that are worn on the human body Staff has come developed a preliminary definition of our own It's basically the same as the other definitions. However, we have expanded it to include chemical electronic and magnetic Technology that's worn or applied or inserted into the body One of the interesting facets of wearable technology that it encompasses such a wide range of products everything from clothing and textiles to Watches to a game pieces that are worn on the head and on the body at which we'll talk about so that's one of the challenges that's understand this very broad range of Technologies materials and how do we make sense of of them? Also wearable technology is growing very rapidly again, there are many different estimates, but it's expected for Calendar year 2019 to wear around 50 billion dollars and that's almost doubled since around 2014 So it is a very rapidly expanding and growing technology Also Very popular is the Internet of Things and although wearable is a separate category It is connected most of the devices that we'll see have some type of connection Either to the internet or to another device through Bluetooth or some other type of transmission So there is this connection to the internet of things So staff has developed a classification scheme for wearable technology to try this to make sense of this again broad universe of products how we can address the hazards so many of the Characteristics that we take into account or what type of product is it? Where is it placed on the body? what's the function and What are some of the foreseeable uses of the product? and this classification scheme we include five Categories accessories articles embeds patches and inserts and I'm going to quickly walk through Each category to give you a better idea of the types of products involved with wearable technology so our first Category are accessories and accessories are worn on the surface of the body They typically are not attached to the body examples are fitness trackers Which I think most of us are aware of watch watches smart watches bracelets and rings They have a number of functions primarily the They involve Physiologic monitoring of the body for example the fitness tracker can track your heart rate It also communicates and collects and stores data So it may Interface with your phone or with a computer and so that is also a facet of the other Categories of products as well some of the other Interesting and and some of these are fully commercialized others or prototypes are warning devices for example There is a device that you can wear to the beach And it will warn you of sun exposure if you've exceeded a certain threshold so there are these types of devices and as Staff involved with chemicals. They're actually chemical monitors and we will see this for example carbon monoxide They're also used in External environmental And air pollution chemistry as well. So these are some devices that are quickly Proliferating on the market one question about them is their accuracy, you know, how accurate are these measurements? And can they be relied upon by the consumer? One other point quick point of the National Academy of Sciences Perhaps a year ago had a Seminar on the citizen scientist and talked about again the greater use of these types of devices Among consumers also some of the potential hazards since they are on the body are skin irritation We are aware of With some products that they there are specific products that have been involved with irritation and other hazards like thermal burns Our next category are articles so articles are typically Clothing and textiles again similar to previous category They war are worn on the body the difference is they typically cover a larger surface area Examples shirts dresses jackets athletic gear backpacks similar functions again They're they're commonly used to monitor the body heart rate Neurological function. They also provide can provide some other Interesting applications including entertainment of some can play music. They have speakers There are others that can change color. For example, you can control the color of the clothing We also have here listed an electronic hug So for example, if you wanted to send someone a hug it provides that sensation and I think that's another interesting Facet of these these products is that many of them can provide sensations to the body also Communicate collect and store data like the other categories One particular area of interest is the use in athletics We know that there are professional sports teams that are using these types of products both For example shirts and pants to monitor the neurological function. It helps them in their training And athletic performance. They can also potentially be used to warn of safety issues So for example, if you're on a playing on a football and I'm talking more high school In junior high that they may potentially be able to monitor and to warn if you exceed a certain threshold Like heat stress or trauma. So there are there's great potential for these products again Not all of these all this potential has been fully commercialized Our next two categories are very similar patches and embeds patches of course as the name implies is Place directly on the skin Embeds are typically under the skin. These are things like chips They're actually circuits that can be placed on the surface of the skin on the fingernails and so forth One interesting application for these products is that they can be used for access to buildings Just this morning. I had issues with my PIV card and so now there are literally companies that are using them either on the surface or as embeds for Employees to have access to buildings There also can be used in amusement parks if you pay for certain Rides of certain sections they can be used there and certainly age restricted activities such as in a bar so quite a number of Potential applications us in addition to tracking and identification one concern That we do have obviously these are on the skin or under under the surface cuts Bruises burns, but also if it's under the skin. Is there greater access to the blood? Circulatory system could there be systemic toxicity again? We're not aware of any issues at this time But it is going to be important that these you know materials have a high level of purity if they are certainly under the skin And finally there are inserts these are products that are placed into the body Most of us are familiar with things like earbuds that we place into our ears in order to amplify Sound they're also products like the smart mouth guard and this is an interesting device You can it will monitor the saliva the saliva chemistry and Provide sort of feedback on the health status of the body It can also be used for head trauma So if there is an impact this can monitor that so again Similar to some of the other products that that ability to be able to monitor trauma and provide feedback in some way And similar to the other products again the potential irritation and since it is in the mouth Maybe in for example the mouth is there a greater likelihood of ingestion of chemicals So we'll move on and talk about the hazards and risks one of these since again, we're we're talking about a Incredible range of products and and potential uses. How do we categorize the hazards? So we are looking for hazard patterns and consequences we're also monitoring potentially higher risk products for example are their children's products and Products that are used on parts of the body and we'll talk about this in the next couple of slides that where the bodies were sensitive to injury So there's a lot of information on these next couple of slides, but we purposely did that I think to demonstrate The complexity and and try and understand the hazards So the first question is where on the body is this device located is it on the arm the leg? Again, is it on the areas of the body that perhaps a more sensitive and more susceptible to injury could they also? Be removed easily or are they attached more permanently to the body? Also the product function we talked about the number Some of the functions for these products, but it certainly is a wide range of functions everything from Biomonitoring which many of these products do Chemical resistance also electrical generation that we've not seen many of these products in the market but there is this certainly I think we could all agree that the Potential for solar technology having solar cells also that would involve some type of energy storage Some type of battery so electrical issues. We talked about the monitoring and entertainment and Also the use of light light therapy and as far as using light in in entertainment And then finally what are the specific hazards and exposures to those hazards? So we talked about where it is on the body the function, but Due to that function what type of specific exposures could we potentially imagine so? electrical chemical Light and combustion and sound as well as thermal So there are a number of hazards that covers many of the hazard areas within the risk management group and again If there may be multiple hazards from one particular product I'd like to focus on one area that the team has been Focused on are the what we call the brain computer interface products. We're seeing a number of products that are have greater Potential impact on the brain and neurological system. One is virtual reality I don't know if everyone has played a virtual reality game. It is really an intense experience You're literally immersed in this three dimensional reality and given your immersion, you know, there are questions about What impact does that have on the brain in the neurological system? Somewhat similar is the augmented reality That's where you're projecting images into our three dimensional world And so for example, there are our glasses that potentially can do that So it's not as intense, but clearly it is changing your reality There are also brain stimulation and monitoring products. So there are products that He purposely stimulate the brain often through electrical current and they are Believed to improve memory and cognitive function. This is exciting. We we've seen just the proliferation in things like Alzheimer's and and memory loss Mondial release. So that's this could potentially be Something to help that population as well as improving memory and learning among younger younger children Also, there are brain Monitoring devices that actually monitor the brain waves and can interpret those brain waves And in fact, they are incorporated into games so that you can control the game through the mind And there are some games that are available At this time and clearly the potential risks with this Certainly if we're talking about direct brain stimulation or more to the cross-reality products like virtual reality Given this more immersive and intense experience What are the impacts that we mentioned and particularly on developing minds and neurological systems of young children? There are other hazards as well since you are immersed You don't see the three-dimensional world and so you may run into objects literally, but again I want to be clear that as far as the brain and neurological system We have not had any incidents time aware of but as we're exploring where the potential issues may be These are some beautiful graphics of some of these products, but I think they emphasize some of the potential uses we have a classroom and I think that education and training is going to be a significant user of these products we've talked to Some of our federal partners and we'll touch on that more who are using this for example doD and in training Their personnel in the upper right is the the brain Monitoring device and in the lower right Not only do you have with the virtual reality the eye? You know the portion the visible portion, but there are also some games that are developing sort of like a bodysuit so that you have Sensations for example if you're at the the beach and So visually you're in the beach setting you might feel warmth or the wind So it does provide an even greater level of immersion in that VR experience So Next we'll move on to what staff that is doing In regards to wearable technology We do have an internal team We do and with that's interdisciplinary We've developed to maintain an internal database and we currently have about 400 products in our internal database again Most of this is based on web searches We have reports that have been written internal reports by the staff as well as attending conferences of workshops And that's really great to interact with the stakeholders to better understand Commercialization and what type of products do we see coming down the pike? Collaboration with stakeholders is critical We have been meeting regularly with the FDA Food Drug Administration as whereas NIOSH and NIST Coming out of one model for interaction has been nanotechnology and many of the folks that are engaged In wearables and 3d are coming out of the nanotechnology community So there's already been these Connections, but we but particularly with FDA we have been meeting regularly with them and discussing issues of Function and jurisdiction as well. We've also Interacted with manufacturers and trade associations We've had manufacturers come in for for meetings and we've also had global outreach We've talked to our colleagues in health Canada EU In particular we met with the German Bureau of Risk Assessment Excellent meeting and it's great to understand how their perspectives and how they align with ours And in fact they have many of the same questions and approaches that we have So we'll talk briefly about jurisdiction again and in this dialogue with our Federal partners that jurisdiction is going to be on a case-by-case basis. So there's not much unfortunately we can say broadly but it's Based on claims based on function based on potential risks That's going to impact the jurisdiction For example, there are Devices that repel that act as insect repellent. So we would think that that would likely be regulated under FIFRA by the EPA as far as jurisdiction and Requirements we we also need to consider how our existing regulations may impact or apply To these new products. For example, we've mentioned textiles the flammable fabrics act or FFA or chemical exposure the FHSA And even some of the products that may not be under our jurisdiction like these drug delivery But under the PPPA is there is there some jurisdiction there? So again, these are questions another issue that comes up in IOT and it's very interesting It's that typically we focus on the product itself But part of this technology is the fact that these products have algorithms Programs apps associated with their function. So how do we deal with that and not just the physical product? But the algorithm especially if the failure of this algorithm or Misunderstanding of it if it can impact the safety of that product So that's a new factor that we we need to address with these new products And finally the path forward What is it that we as a team think we need to do as we move forward? Clearly to continue to identify the hazards within each product group to identify to understand the market and Quantifying the risk to consumers also voluntary standards are going to play a very important role In in in addressing the potential implications of these products We've begun to engage in the bonus voluntary standards activities and Again, that's going to be critical for addressing these issues So in summary wearable technology is a rapidly evolving landscape The regulatory jurisdictions they're going to be questions, but again, that's going to be Handled on a case-by-case basis. We're working to understand these technologies To organize them into categories to understand their potential hazards And as always it's important for manufacturers and other stakeholders Many people use that term risk governance that we're all in it together And we all have to do our role to ensure that these products are evaluated and that there are any potential Hazards or risks can be adequately addressed So I want to end by thanking the the staff. We've had so much hard work come from the From the wearable technology team as well as the Parms It has truly been a great and I think fun effort and again understanding this this area and learning more about it So that I'll be happy to take questions So, thank you very much absolutely fascinating presentation And you've got a wonderful team that's doing a lot of incredibly interesting work So this always brings me back to a Thought I have and that is I think it's important that we be Ahead of the curve in terms of addressing emerging technologies I always worry at times about the shiny object about what's she she ocaron state of the art cutting edge Capturing or capturing our attention when we still have fundamental risks that we got to address So here's a tough philosophical question if I might on a scale from one to ten if at this point You were to rank where you think wearable technologies fit in terms of risks that we should be concerned about Could you give it a number and could you give a reason for that number? I? Didn't mean to hit you with anything too heavy You know it's still because you you've been do it dealing with nano and that was that's another area where I've had that similar kind of question I Can help dr. Thomas a bit. I think this is one of the areas we've certainly seen Existing hazards with these products They have been fortunate the minor scale I think our intent in this area is to try I think as you know to get ahead of the curve Work with the standard development organizations to sort of head off those hazards I think what we have here is an opportunity to do just that we can work with the the community in that area and Keep this out of the 910 range and keep it down at a less concerning level Thank you. Let me return to planet earth if I might and I'm sorry to hit you with such a heavy question One of my ongoing concerns and you touched on it is with respect to elderly and senior citizens Do you see a whole area of? products coming out that would Not only protect seniors in terms of warnings, but also be affirmative things that would help them Maybe Andy fall devices or anything like that. Is that? Is that something that has captured your attention? I think so absolutely. I think in terms of We've mentioned biomonitoring and so it can help understand what's going on with the body also even the brain function You know so I think overall and one thing I did not mention is with some of these products For example, there's clothing that even if you're stressed it can send a message to a loved one and they One particular manufacturer at a commercial where someone stressed The the article clothing sent it to their loved one and they probably gave you a right after gave you a hug But it wore them so although that's that's lighter than what you're asking But certainly yes, you can they can also contact a physician And other medical personnel, so I think that is really an important and I think very exciting part that can really help people So monitoring that as well as the therapy again, not our jurisdiction, but I think you know more the therapeutic Aspects as well and oftentimes they're combined. So yeah, I think it's important to really think about You know the potential Benefits to the the consumer from this technology Yeah, and I also love the fact that you've reached out to other agencies because jurisdiction is going to be so fluid and so Flexible and overlapping at times and so this also popped in my mind We had a terrific and have a terrific task force on nano technology. Is there any move in addition to IOT? Federal task forces to have one dedicated to this or will this probably be just a sub chapter a sub part of the IOT federal task force well actually there is a nano sensors group and I you know we Participate in that so again much of the nano community because they're looking at ways to apply nano technology To sensors to miniaturize them so they can be incorporated into clothing and and the rings and other devices So yes, that is ongoing. We participate in that and again it that that sort of model of interagency Collaboration and sharing of data is is going not only from this area, but to 3d and to wearable So that's certainly exciting and I'm gonna touch just a little bit on your earlier question I think one of the lessons that we learned about nano and I was there from From pretty much the beginning there were a lot of concerns but I think through interagency collaboration and Coordination we've been able to address a lot of those issues the sky was not falling the gray goo is not gonna destroy us So I think that we have been able with good robust science and research be able to address those questions So I think that that provides us with a good model for again interlink agency Collaboration as well as the ability to address the implications and risk as well as one other thing too I think for stakeholders to change the paradigm. It's not the government coming after you But we're working with you. We wanted to responsibly develop this technology So it's it's good. So your R&D. You're getting the scientists the material scientists the R&D developer and the toxicologist at the table I don't know how successful we've been but I do think that there has been that shift in Thinking so that we think about health and safety from the very beginning and not when you're about to commercialize Well, thank you my time's up, but you're the perfect person to address that issue. So again, I appreciate it commissioner K Thank You mr. Chairman. Thank you. Dr. Thomas and to the rest of the team for great work. Just excellent excellent work I wanted to dig into some of the areas that you were just talking about specifically starting with the collaboration outside of the United States and You mentioned talking to one of the member states in the European Commission the Germans I was curious at the commission level the European Commission level though Have there been a lot of discussions or any discussions with our staff and the European Commission staff about? How they see this issue With the wearables not as much at the Commission staff Commission level, but certainly as I mentioned at the state level Again Germans being one of the largest markets. So we're starting there, but we anticipate Expanding that more and I think you know to the earlier question of collaboration I think many of the Same group same staff that was involved in nano is also looking at some of these other emerging issues So I do anticipate for war collaboration. I see and was when during the NNI initiative was the how much? Collaboration was there with the Commission itself the European Commission itself. Oh, there's extraordinary amount We have what's called the USEU communities of research and it's just been extraordinary Collaborative effort we have annual meetings We the and this is where researchers from the European from Europe and the US but even government But it's it's focused quite a bit on the research community and we've seen projects come out of this collaborations even CPSC funded work that That that has really pushed the science forward and the health and safety So again, we we look to that as a paradigm for interaction with the EU. That's great to hear looking forward to more of that You talked about industry collaboration and the goal absolutely being to build safety and on the front end Obviously, we spent a lot of time on that over the years and one of the things that we've discovered is that a lot of the time In particularly with startups, they're so busy trying to stay funded get funded get their idea the proof of concept to be effective that they're often just not aware of safety issues and so What have you all been able to do to try to bridge that gap more so that in particular as these small startups that are often funded in incubators or by Silicon Valley Entrepreneurs to really reach them so that safety is built in on the front end Well, I think in attendance with meetings, there's been, you know, personal Conversations we look at we anticipate participating more perhaps providing Talks on CPSC Unfortunately when we go out a lot of people are not aware of CPSC So I think part of that is going to involve, you know more Understanding who we are our jurisdiction and reach out again the voluntary standards I think it's one way to do that But I think attendance at these conferences particularly when you find as you said a lot of these are small startups Even in graduate school, so they just aren't aware of the regulatory landscape But I will say one final thing. It was great. There is one conference I do attend regularly and finally they did have a at least one speaker talk about the need to understand regulation So we are moving forward, but there are certainly things that we can do to outreach more with these With through the conferences and that speaker was not a CPSC employee That's good. And in terms of so the work that you've outlined and toward the end of the slides that the staff is doing That's all currently funded work, correct Yes, and so is there additional and if you and your team had additional funds Would you be able to do more or some of it just Can not be done sooner because the time is just not ripe to spend that money I'm trying to understand that if the Commission were to provide more funds Through the mid-year for instance, would that make a difference in terms of the pace of the staff's work? I can help out a bit. I think one of the One of the challenges we have in this area given where we're at in the dialogue particularly with standards development organizations Our limit is at this stage the human capital and not the fiscal capital that we can Leverage through the mid-year process Meaning we need more people. I think we're limited by the number of people we have here So this is I think as Acting chair noted earlier. We have to balance this work Hazards that we're working with them and so we have we have to make that adjudication Got it And then on the people front mr. Boniface that you're responding to that too. We feel and we obviously have a great team We know we've a great team But do we have the depth of expertise that we feel that we need in light of these issues that have been identified I think that we have an outstanding team. I'm truly Truly blessed with this team. I think couldn't be prouder with them, but I do think that we have Deep capabilities, and I think the Commission in the operating plan identified a path for us to bring in External help and so we are actively pursuing that great. Thank you so much Thank you Commissioner Bianco Thank you, and thank you. Dr. Thomas and mr. Boniface. This is a fabulous presentation It's as exciting as it is scary to me The one thing a couple things that jumped out at me I do agree with you dr. Thomas on the voluntary standards front in fact Often when I was speaking to different conferences That is the one thing that is consistent throughout my remarks to those organizations or entities that are Leading the way through technology. I tell them all the time get in front of this get a voluntary standard in place You know what the safety pit falls are So address them first, so I do think that's a good way to start, but that leads me to my second second question or comment and Probably my biggest concern and that is the definition here and the jurisdiction and how we divide this up I was looking at the the definition in your slides, and I understand as a working definition I wanted to know why you included chemical I was trying to get an idea and you helped me along through the Presentation get an idea of where the chemicals come into wearables But that made me think how many of these wearables really are more medical devices as opposed to consumer goods Well, I think the chemicals specifically for example, there are Products that will change color, but it's more of a chemical reaction rather than computers So we incorporated that so it might react to the atmosphere might react to your body heat or so I think we wanted to include those products more of a reaction rather than the actual actual having a chemical in it Right. Yes. It's it's a reaction that brings me back to the hugs That's gonna bring us up to a whole new level of employment law sending hugs each other On a that you mentioned that trying to divide up the Jurisdiction it was on a case-by-case basis. Is there any way at this juncture for the agencies? Because I can see you know one of the products you were talking about talks about You were talking about reliability and it tells us you know x or y or sun exposure and whether that sun exposure It's telling us is actually correct. That made me think gosh. There's FTC issues here. There's FCC issues here There's FDA issue issues here not to mention CPSC and I wonder if it would Help to try to Divide up the products and start putting them into Appropriate jurisdictional categories so that we know we know what our core Function is going to be as opposed to it could be this or it could be that And I know the term wearables is very broad But you know when we're talking about brain activity and Alzheimer's and things like that I wonder if that's more appropriately dealt with the FDA as opposed to the CPSC Well the team has tried to do that and I think part of our Meetings with FDA is to do just that are there areas that we can exclude that are clearly ours And again, I the jurisdiction issues clearly I will defer to general counsel But I think we have tried to do that, but it's difficult and I think that there is it's really Gonna be on a case-by-case basis, but I think as much as we can to try to carve out what's ours and and what is not I certainly will attempt to do that. Okay? I've been reading a lot about performance fabrics with minerals in them or silver Silver threads or electronic threads that you can actually scan and it'll give you some feedback on performance or whether the product is authentic or not Are we? When I look at the definition of wearable technology, I'm not sure whether or not our Working definition captured that am I missing that or is that something that we haven't addressed yet or is it too new? You know it's a working definition And and I think that you know we're trying our best to try to capture just starting out What is it so it's going to evolve over time you know what you're saying? There's so many new product there's so many new products coming online And we're trying to make sure that that definition and then the rule change I'm sure over time and it's something that we've just used someone internally for our team purposes But I think as you know as we all move forward I think that will update these definitions and and also I think looking as we look to our federal partners How they define it as well as the industry so I think it's just an evolving process And I wrote down here. Do we have a list of specific examples? And I think you said we do we have about 400 products captured I'd love to see what that is and if we could highlight maybe Which of those are the children's products would be of particular interest? I would I would love to see that because I can't even think of 400 different products That would be wearable if you will but thank you very much. My time is up. It was just excellent presentation. Thank you Thank you commissioner Feldman. Thank you acting chairman Adler and thank you. Dr. Thomas and mr Boniface for the presentation and the work that you put into this I think that this is a product segment that's incredibly exciting and You've done a good job today Discussing some of the potential and currently realized benefits that wearables have to offer As CPSC determines what its posture is going to be with respect to wearables Or for that matter all emerging technology including IOT and 3d printing like we discussed a couple weeks ago It's my view that it should do so with an eye not only to our safety mission to protect consumers from unreasonable risks of injury and our statutory obligations But also with an eye towards preserving innovation and keeping barriers to entry low That the benefits that you've discussed Aren't actually going to be realized if firms are regulated out of existence Or the barriers to entry to the market are so high that consumers aren't able to take advantage of some of the exciting things that this technology Currently has and will potentially have to offer in the future But to that point what is CPSC currently doing and what more can we do? To make sure that this product segment remains vibrant and competitive Well again, I think ensuring that products are safe I think the last thing we want is for something to be recalled So I think that as we've mentioned, you know reaching out to Manufacturers making them aware and not just CPSC, but all of the federal partners making sure that they are aware that You know that the regulations exist to voluntary standards exist and that they participate I mentioned earlier when I was at this wearables meeting and there was this Presentation on regulation Again, we're talking about in many cases grad students very small people that just have put a lot of work use credit cards to pay For research and they want to get it on the market So I think that outreach to them that you have to consider Health and safety not just the regulator going after you, but it's good for your product You don't want to invest the time and effort and then it harms someone. It's just not good for anyone So I think that has been the message and so we'll continue to dialogue and work in all of these sectors voluntary standards Communicating with industry through conferences and other things To get that message out great and with respect to voluntary standards Can you talk a little bit more about what your and staff's role has been and will be in the future with respect to SDOs? Well, I think two things want to participate We also are looking for ways that perhaps we can suggest Voluntary standards for product categories. So I think that's where this categorization is so important What should we focus on and could we depending on the appropriate voluntary standards? Organization perhaps recommend that there be some activity great I hope that moving forward we can continue the dialogue so that the commission can actually work to help direct that conversation In a way that's that's useful and meets all of the the objectives that we're talking about today You mentioned that there's a bit of a crossover between nanotechnology and wearables if if if for no other reason then it's a lot of the agency staff that had been previously tasked with With working on nanotech that's now sort of feeling its way into the the wearable sector With nanotech that was a significant agency expenditure it focused Fairly heavily on on hypothetical risks that weren't necessarily Ultimately realized I'm wondering that in your experience Are there any lessons learned from nanotech that may be applicable to the current discussion about wearables? well, I think you know again we having the interagency collaboration and And more importantly the stakeholder outreach. I think Nana was unique We had a coordination office that not only brought the agencies together But also this all of the stakeholders the industry academia as well as the NGOs So I think that in many ways and we're in a kind of reflective time. It's been 15 years since Dan and I but I think In many ways and and I've been involved in it there There is a victory there that that we have addressed it wasn't as hazardous as perhaps we thought in some instances And again keep in mind nano is is continuing Continuing to evolve new materials and so forth, but I think What was good is that we were able to address the environmental health and safety issues I remember in the mid 2000s there was a scathing report that was published on CPSC and our ability and other agencies to address this And they just said it's too complex we have been able through robust research and Working with our not only our federal partners, but academia and others to address it So I think the lesson learned is that you know, we are able to to to identify what those issues are with nano. We had a a strategy document for health and safety and we were able to understand what the agency roles were Very good. My time's expired. I appreciate y'all being here Uh, thank you, and I just have one or two questions and maybe a comment I did want to pick up on what commissioner Feldman and also commissioner Bianco were saying about voluntary standards I think developments here happened so quickly that the idea of having mandatory standards written It is probably a big challenge and one. I hope we never face So if we're going to rely on voluntary standards and the only fallback from a voluntary standard that fails Aside from a long laborious process to doing a mandatory standard is a recall And I hope we don't reach either of those concerns But that does lead me to say and I do want to underscore the need for us to be proactive And I was pleased to hear you say that we're not only Participating but we're also suggesting and I would urge you and the voluntary standards folks to continue to do that I guess one quick question And this is always an issue when it comes to chemicals for example because we do worry about the acute hazards But then there's always the chronic hazard that's lurking. Are we thinking about? Chronic hazard concerns as much as we're thinking about acute hazard concerns and have we identified anything? That seems to be a particular area of chronic challenge that may not exist in the acute world We're chronic now at this time. We have had some issues with the acute hazard So but I think that goes into what we've described in this stepwise process of understanding the technology Understanding the types of materials that are being used. I think one facet of this is the People going from nano to quote-unquote advanced story verging materials. So it's an evolving side I think part of our challenge and that my own program, you know has changed And longer to reflect that so I think that part of our job is to definitely understand What are the overall hazards both acute and chronic and I think? Also when we talked about our categorization scheme not only where it's on the body But how long is it perp? Let's say permanently attached if so then we have to be concerned more about Chronic hazards or even if it's not but it's used, you know regularly and number of hours used for example The virtual gaming, you know, are there materials there? So I think that's the the thinking and the rationale that we have and I think again Those are the lessons learned from nano that you know, how do we approach? Understanding new certainly from the chemical nano as a quote-unquote chemical. How do we understand and and is there a Methodology to understanding these hazards. So I think we have a good model to use Thank you having over further questions at this time commissioner Kaye none. Thanks again to the staff for a great job Thank you commissioner Bianco. I have one thing. I love your point about Reaching out to the grad students and starting that thought process about safety with them. I do know I Actually been looking at this myself. I do know Penn State Has a an advanced in their master's program for their engineers an advanced course that they give in the summer Which is you know the law and what they're doing particularly in additive manufacturing and and I would suspect that that could be extended I have spoken with one professor there and just chatted with him about what's in the course now and what he could add If you wanted to consider it and I I'm thinking that that might be something that we toss around a little bit and maybe have a Cheat sheet if you will or a checklist that we want to make sure it gets out there on the very basics as these programs are being Developed the companies are being funded and the students are learning their trades. I think that's a great idea. Thank you Did you have no, I hate going back keep going back to nano But I do think that that's one of the things that we do have through the national now technology coordination office webinars and I they've been very effective in Reaching out to the stakeholders particularly the academics and understanding the safe use of these materials So again, it is a good paradigm and and you know, they can be archived So even if you can't watch them alive, you know, you can go back to them and even have training programs So I think there's a lot of talk about that you mentioned centers And that's another thing another thing too if there are centers of excellent centers of research to target those and to say is This part of your curriculum that helped in safety So again, it's part of that changing of the paradigm that we get to the grad students not just for emerging and but just overall That you must consider safety, you know as you're as you're developing any type of product It should be automatic. It should be part of the development the whole developmental process. Absolutely Well, let's keep that dialogue. I'm going because I'm very interested in that and maybe we can come up with something Thank you Thank you commission Felburn. Thank you I definitely want to keep this dialogue going and I just want to circle back to something that you said And and commissioner Bianco said and I don't remember probably commissioner Kay agrees But I don't want to speak for him, which is just how important the the the voluntary standards process here is and will be in the future When we were meeting to discuss the the operating plan for 2020 We took a specific look at the voluntary standards development for emerging technologies, and I think that would include What would include wearables and in IOT? and the way it exists right now it calls for you know a significant amount of commission involvement in in in sort of direction to staff about Figuring out what the what the best path forward is and what that participation should look like So I do hope that we continue this conversation and that we continue the conversation amongst the four of us to direct that staff participation in a way that that maximizes all the benefits and and Risk mitigation that that we've been talking about today last question and and this is Echoing something that commissioner Bianco brought up When you put together the classifications It's it's You did a good job of outlining sort of what considerations you you put into that But as you're surveilling the market right now and looking at products that are coming online Does it make sense to to think about a separate and distinct classification for children's products? That's the way the agency handles children's products with with respect to other market segmentations Well, we have in a way I think when we talked about the brain stimulation devices and the VR that's Part of because children typically will use many of these games. I think that's part of that effort As as well as you know, again, that's a good suggestion I think with all these categories are there specific children's products So we can you know look at them as as a subcategory right or or maybe maybe in addition Infit and toddler products. Can you talk a little bit about what what you're seeing in the marketplace? Those We're seeing some the monitoring type products And I think one of the questions is whether they are under our just because some of them are therapeutic For example, there's a blanket that uses light therapy So there are questions on these jurisdictional issues, but we certainly have seen them and again a lot of them are therapeutic monitoring type devices, okay Again, thank you very much. This has been a very interesting and exciting conversation Thank You commissioner Feldman and of course along with worrying about the vulnerable population of children Let's not forget the seniors I want to make sure that the commissioners have asked all the questions they've asked So may I see if there's any additional comment question? If not Dr. Thomas and mr. Boniface, we can't thank you enough for a superb presentation You really got our brains working this morning without any excess our external stimulation I want to thank the wonderful staff sitting behind you who have done such terrific work on this project We can't thank you enough for this and therefore this concludes a public meeting of the United States Consumer Product Safety Commission Thank everyone