 Good afternoon. Welcome to the CPSC staff public meeting on phthalates. I'm Michael Babbage from the Division of Health Sciences and also the project manager for phthalates. Today's meeting is one in a series of public meetings on the Consumer Product Safety Improvement Act, or CPSIA. Today we'll be discussing Section 108, the prohibition of the sale of certain phthalates of certain products containing specified phthalates. Today's meeting is being webcast over the CPSC website and it is being recorded and will be available for viewing in a few days. Let me begin by thanking all of you who have responded for our request for information and comment. Your responses have been very thoughtful and they really are very helpful to the staff as we prepare to implement the CPSIA. We have two goals for today's meeting. First, we want it to be a dialogue between the CPSC staff in the public. We'll do our best to explain the requirements of the CPSIA and answer your questions, but we also hope to learn from you from your knowledge and experience on the issues that are at hand. Our second goal is to focus today's discussion on the practical and technical issues. Now the agenda for today is as follows. First, we'll have brief presentations by the members of the CPSC staff. Then this will be followed by a general discussion of Section 108. So in the interest of time, we ask that you reserve your questions for the discussion later on. Now let me begin by reviewing the requirements of Section 108 of the CPSIA. Beginning on February 10th of this year, there was a permanent ban on a manufacturer, sale, distribution, or importation of any children's toy or child care article containing more than 0.1% of these three phthalates. Di-to-ethylhexyl phthalate, dibutyl phthalate, or benzal butyl phthalate. Now it's important to note that the 0.1% applies to individual phthalate compounds, not the total amount of phthalate in the product. Also beginning on February 10th was an interim ban on the manufacturer, sale, distribution, or importation of any children's toy that can be placed in a child's mouth or child care articles that contain concentrations of more than 0.1% of these three phthalates. Again individually, diisodenol phthalate, diisodesyl phthalate, and dienoctyl phthalate. And this interim ban will be effective until the Chronic Hazard Advisory Panel completes its study of these and other phthalates, and the Commission promulgates a final rule. One of the CHAP's responsibilities will be to make a recommendation on whether there is a need to continue the interim ban. Section 108 contains some definitions that are specific to this section. First, a children's toy is a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays. A child care article is a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age three and younger or to help such children with sucking or teething. So it's a very specific or fairly specific definition of what aspects of child care are covered. In addition, the requirements also refer to children's toy that can be mouthed. For the purposes of this section, a toy can be placed in a child's mouth if any part of the toy can be brought to the mouth and kept in the mouth by a child so that it can be sucked or chewed. If the children's product can only be licked, it's not regarded as able to be placed in the child's mouth. And also, they include the five-centimeter rule. If any part of the toy has any one dimension of five centimeters or less, then it's considered that it can be mouthed. And so with that, let me begin by introducing Celestine Kiss of the Division of Human Factors. Celestine will talk a little bit more about exactly what constitutes a toy and a child care article and so on. Celestine? Okay. Now I got it. Good afternoon. Thank you. As Mike said, I'm going to talk about the scope of Section 108. And in my presentation, I'm also going to be asking questions. So feel free to make notes about the questions I'm asking you for the discussion later on. So the first part of Section 108 I want to talk about is children's toys. As Mike said, in this section of the CPSIA, a consumer product, a toy is defined as a consumer product design or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays. And we are directed to consider four factors when we are looking and trying to decide if a product meets that definition. One thing is the manufacturer's stated intent, and that means if it's on the label, if it's on the packaging, it's on any advertisement that they do or how it is marketed within a store. Two, we look at the packaging, the display, the promotion and advertising. All of it together we take into consideration. Then we look at whether it is commonly recognized as being for children 12 years of age and younger, and by that we mean does the general public agree that this is intended for children 12 years and younger. And we also use the commission's age determination guidelines as a source of determining what children are capable of doing at different ages for different products. Now in the last part of the definition, we're talking about toys that are intended for children when the child plays. So then we need to look at what is the definition of play. So we looked in Webster's dictionary and we came up with a couple definitions. One is to occupy oneself in amusement, sport or other recreation, and specifically children playing with toys. Recreational activity, especially the spontaneous activity of children. And third is exercise or activity for amusement or recreation. When we are looking at how do we get a grasp on what is a child's toy, we also looked to other sources. And one other source was ASTM voluntary standard F 963, which is the standard for children's toys. On February 10th, 2009, CPSIA mandated F 963. So we thought that would be a good spot to start. In there, they defined toy as any object designed, manufactured or marketed as a play thing for children under 14 years of age. They also list a number of exclusions, bicycles and tricycles, slingshots and sharp pointed darts, playground equipment, non-powdered guns, kites, art materials, sporting goods, camping goods, athletic equipment, musical instruments, furniture and powered models of aircraft, rockets, boats and land vehicles. So we thought, okay, why did they exclude those, should we use those same exclusions? And at first we said, yeah, maybe we should. And then we started looking at them again and said, well, some of them may have been excluded, not because they weren't toys, but because there were other voluntary standards. And so this is one of those areas where we would like your feedback. Should these exclusions be kept also in terms of section 108? So those are just a list and I'll have this list up again during the discussion so you can be thinking about should they be included or shouldn't they? One of the things that I do want to point out are sporting goods. Now regulation basketballs and baseballs and etc. are designed in that way to play a specific sport. But there are also toy versions and they are maybe foam balls and plastic bats. And so the question is, does play, is play being defined the same way? Is it being applied the same way when you talk about a regulation baseball and a plastic bat and ball? Are they two different things? Should we look at them as two different things? So that's where we're thinking in terms of how do we identify what's really supposed to be covered. So that's toys. Then we have some other items that we've been asked, does this apply or doesn't it apply? So what I've done here is I've just made a list of some of the things that we've been asked and I'm asking you to consider these. Should these be covered under section 108? Novelty books. Now I don't mean just a regular paper book. I mean a book that has some kind of interaction such as some of these books now where you can push buttons and they make sound effects along with the story. So there's an interaction of the child and the book more than just reading the book. Bath toys, pool toys, waiting pools and one of the things with waiting pools and I'm going to get to that is the issue of whether it's inflated or deflated and the mouthing aspect of that. Dolls, action figures, costumes, masks and balloons. Again, these are just to keep get us all talking and thinking about what all it really needs to be involved here. Toys in a child's mouth. In section 108, they say a toy can be placed in a child's mouth if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked or chewed. If the child's product can only be licked, it is not regarded as able to be placed in the mouth. And again, this is the five centimeters. If a toy or part of a toy in one dimension is smaller than five centimeters, it can be placed in the mouth. So that so as I was saying with the waiting pools, the issue is you've got an inflatable product, whether it's a waiting pool that the parent hasn't inflated yet or maybe a beach ball that you buy it uninflated and the parent is intended to inflate it. So do we if it's an uninflated state, it's less than five centimeters and a child can mouth it. So staff's opinion is that it should be covered. But we want to hear your opinion. So the next area. So we have three areas with the toys with the toys that can be mouth and then we have the childcare articles. Childcare articles are defined as consumer products designed or intended by the manufacturer to facilitate sleep or the feeding of children age three or younger, or to help such children with sucking or teething. And again, the CPSA did not define facilitate. So we went to Webster's dictionary and they say it is to make easier. But the question is, who does it facilitate? Does it facilitate the child or the parent during the feeding, sleeping, sucking or teething process? Staff's position is that there really are two situations here. There's a primary situation where a product is used directly by the child. It is in their mouth, for example, a pacifier or a teeter that has direct mouthing contact with a child. And we would call that a primary product that is being that is facilitating the child. A secondary product is a product that we consider being used by the parent, but we would really have no contact with the child. And by that, talking about, for example, a bottle warmer, the parent warms the bottle with this machine, and then gives the bottle to the child, but the child is not using the bottle warmer. So therefore it's facilitating the parent, not the child. And we consider that a secondary product. Now those are the easy ones. Now let's get on to the harder ones. What about products that are not necessarily in direct physical contact with the child, but in close proximity to the child? For instance, the crib, the crib mattress, the child is sleeping, technically, the child is sleeping on the mattress, but there's a mattress pad between them. There's a sheet between them. How, where do we go? Where do we make that line? Toddler mattress, mattress covers and mattress pads. These are all items that child is using during sleep. But how much contact are they having? The next thing is multiple function products. Now, as you recall, I said one of the four things we have to consider is how the manufacturer is promoting and advertising their product. So you have a stroller or a swing or a bouncer just for examples. These are items that have multiple functions. The stroller is used to help transport the child. The stroller has a reclining feature so that when the child is sleeping, it can sleep in the stroller. So it's, it's being advertised as having a function of facilitating sleep. It also has other functions. So the question is, do we consider that a primary or a secondary product? We also have to consider what is commonly recognized. So if a manufacturer says suddenly stops advertising this as a facilitating sleep, does that mean that consumers are going to stop recognizing it as facilitating sleep? That's what we have to consider. So that's a very quick broad outline of what the scope is. So here are questions. Does the staff's approach to determine which products are subject to the requirements of CPSIA section 108 provide clear guidance? The ASTM F 963 exclusions, should they be followed or should we go a little bit further and decide which ones maybe some and maybe some should and some shouldn't? And are there other classes of products or specific products that should be excluded? And with that, I'm going to give you a nice long list. But don't worry, we're going to have this up again. So you don't have to write all of these down. But these are some of the classes of products that we've said, okay, is it a toy? Is it a childcare article? Or is it something else? pacifier, bib, pajamas, crib or toddler mattress mattress covers, crib sheets, infant sleep positioner, play sand, baby swing, decorated swimming goggles, water wings, shampoo bottles with animal or cartoon characters on them, costumes and masks, baby walkers and waiting pools. So I hope all of these are going through your head and you're thinking of, okay, how do we make that distinction? And how do how do these fit into the categories that we that we have to decide? So I'm going to I'm going to leave it at that. I'm going to turn it over to Joel now. And he is going to talk about the the testing. Thank you. Thanks. So yes, my name is Joel wrecked. I'm the chemistry division director. I noticed that I've left my contact information off of the slide. Perhaps that'll stop my phone from ringing. But it seems you've all found how to find me in the past. I suspect you will again. I do want to point out something that has been on the first slide of all of our presentations. And this is our standard standard disclaimer that these comments are the staff's comments and they're not the commissions. I want to bring it out because I you know, we're here. I mean, it's kind of obvious from it. We're asking about some of, you know, what we've interpreted. We've been trying to give guidance. We have things published on our website. We continue to publish things on our website. The rulemaking isn't necessarily completed in all these cases or it's not in most of these cases. In some cases, it's far away. The testing method for phthalates, for example, we don't we're not required by the CPSIA to publish a method for it publish a rule for accreditation for third party testing for several months. But we want to, you know, get your input and get a dialogue going. We want to provide the best guidance we can. However, as we get your input, some of this could change. And certainly, if the Commission rules, they might not rule the way we're saying that we don't want to pretend differently. But this is the best of what we have to say. And that goes for all of us. That's why we're here asking you questions. I have a second disclaimer to give specific to mine. I want to warn you, it's a chemistry talk. I'm going to talk about chemistry. I know you're not all chemists. I have a family full of other people who aren't chemists. I know what happens when I talk to people like that about chemistry that not everybody likes that. But there are some chemists out there and we have some chemical questions and issues. So no real way around it. So I'll try and bear with me if you're not a chemist, and I'll try and make it understandable to all of us but we've got to cover some of the technical aspects. As Mike mentioned, in evaluating the phthalates, the Section 108 of the CPSIA bans the total phthalate content in a toy or childcare article. Again, there are six either prohibited or interim prohibited phthalates, just as were mentioned previously. As I alluded, we've published on our website a method for guidance on how you can do some of this testing. The general theme of our method is to grind or mill a toy into a powder. Dissolve or extract that powder with tetrahydrofuran, a particular solvent, precipitate PVC that might have been in there with hexane, and then analyze the remaining solution with what we call a GCMS, a gas chromatograph mass spectrometer using select ion monitoring. We're seeking comments on this method. We've gotten some, they've been helpful, and I'm sure the CPS labs who are here and those listening from afar will have further comments. In our method, we refer to several alternate methods and there are others as well that may be worth considering. Some of the other methods, again, I've just put a table here together. Our method is CPSCCHC100109, that's at the top of there, but there's a method from ASTM D7083, which involves a six hour SOXLID extraction in ethyl ether, followed by analysis by a gas chromatograph with a different type of a detection. This method might have some limitations in selectivity to be able to differentiate the different phthalates that might be present in things because of the flame ionization detector. But it is a method that's out there and we're certainly interested in your comments. It also takes longer and the ethyl ether can be an explosion hazard that's more difficult to work with perhaps, but it certainly think something used by chemists in chemistry labs. Another method that we listed was EPA8061. This method itself refers to several different extraction methods, including SOXLID extraction, microwave extraction, ultrasonic extraction, and they recommend a combination of methylene chloride and acetone as the solvents. They then specify an analysis by a different, yet another different detector by gas chromatograph. Health Canada has a method that uses a two hour extraction in dichloromethane, followed by a 12 hour precipitation and methanol and an analysis that's fairly similar to the one that we specify, but with a slightly different mode of ionization, little technical thing there. And in Europe, there's a method EN14372. This has a different extraction method than we use. It's more similar to the ASTM method. They then heat the product to dryness. They have an optional gravimetric step where you can simply weigh how much stuff you extracted. And then you can re-dissolve that extract, and they recommend a GCMS method very similar to the method that we have listed, but they don't necessarily require that. So we're certainly interested in comments on that. ASTM F963 refers to a method ASTM D3421 for DEHP, but that method was withdrawn without replacement quite a few years back. Anyway, in our method, again, just to illustrate, we take a toy, such as this rubber duck, cut it up into small pieces, cryogenically mill it into a very fine powder. And you end up with a very fine powder. You can hopefully see in that picture. And that's a large part of actually the issue is how to do the sample preparation is one big part of the method. A second part of the method is the analytical tool itself of the gas chromatography or other methods that might be useful for analyzing. Some of the issues that we've seen for testing phthalates, certainly I'd encourage you to take a look at our frequently asked questions page, which has some of this. One issue is that the 0.1%, as was mentioned before, is for any of the six. It's not the total of the six phthalates. One important thing to note is that you have to be careful in any of these methods to be able to differentiate alternate plasticizers, which are not banned by CPSIA, although I do point out that those are still covered by the Federal Hazard Substances Act. An issue that we've been really struggling with is the different language between the CPSIA and the EU's similar ban. But in our case, the legislation reads that the ban applies to any children's toy or childcare article that contains concentrations of more than 0.1% of the regulated phthalates. The European ban is per plasticized part and has other differences in the wording that are differences and that we have to treat it differently. There's no inaccessibility exemption as Europe has interpreted their rule to include. We're certainly interested in possibly considering alternate methods besides those that I've listed. One alternate analytical method that isn't necessarily separate from the sample prep techniques would be using LCMS, liquid chromatography mass spectrometry. If one of the test labs or if somehow together, subject to antitrust laws, if you would submit a method, we might consider that. I've not seen a published method available for LCMS so we didn't include one. Another question has been about composite testing and we'll certainly seek your comments on that. In identifying the different phthalates, as I said, there's a couple of issues here. Some of the regulated phthalates are complex mixtures and some of them share similarities with non-regulated phthalates and so great care must be used to identify them properly. I've got a picture here showing a typical chromatogram that's some of the output from a gas chromatograph. What you see as time progresses to the right on this graph, different compounds come out of the gas chromatograph and go into the detector after being separated. Well, in some of the cases like dibutal phthalate, benzobutal phthalate, diethylhexylphthalate, you get a very sharp peak because it's a pure compound that's very well defined but in some of these cases, the DINP and the DIDP, and I'm pointing with the pointer here on the screen in this region, there's a big hump of many peaks that come out all close together and that's because these are actually mixtures of many different very, very similar chemicals. Complicating this further, there are other similar chemicals which are not among those six that might come out and share some of those similarities. So it's important to do some qualitative work as well as the quantitative work to, if you find that there is the phthalate present, that it's actually one of these six and not one of the similar ones, a linear phthalate that's not the branched phthalate in the case of DINP or DIDP, for instance. What this means, and here it gets even more chemistry, my God. The staff considers that DINP is any isomer or mixture of isomers, and I apologize, I got no way to say let's accept this, of diesters of phthalic acid with any branched nine carbon alcohol. And what that is, the phthalic acid is the part of the molecule here on the left from the this hexagon, which represents a benzene ring, up to the carbon with these couple of oxygens, the C's and O's here connected. And with the C's, with these coming off it being in on adjacent parts of this molecule. I'm sorry, I just get there's no other way. Because one of the things that could be different, you can have where these chains that come off to the right, where these chains that come off to the right could be placed in different positions around this ring. Those are different compounds, those are not phthalates. So if the if the two chains were on opposite at corners points, vertices would be the right word, instead of adjacent ones, that would be not a phthalate, that that's a different product. But another thing that complicates this is those branched chains where I wrote on the on the right side of the this depiction of the molecule C9H19 parentheses branched. You can branch those chains all different ways you could have what it isn't is nine carbons in a row all lined up with with the hydrogens on each of those that would be a different product that would be a linear dye and no no no phthalate would be something else. But the for the branches you could have eight carbons with one carbon branched off on the second or the third or the fourth or the fifth or the sixth position, you could have seven carbons with two different one carbon branches you could have sit you know there's a huge you know you can do math and it's it's it's hundreds of different confirmations possible, especially when you consider the two different branches could each be different from one another. This is very complicated by the fact that some people sell products which are particular isomers of this as opposed to or or mixtures of much fewer isomers and others by different manufacturing processes might have the more of this kind of the varieties in this present. So it's a very complicated question or seeking your comments on it in in the European legislation they refer to two particular CAS numbers which are both different slightly mixtures of these different branched isomers. But they also go on to say or other CAS numbers for those for that substance and they call the substance you know this branched isomers. So we believe that any any branched isomer mixture or any single branched isomer is dinp such so long as they appear you know in those adjacent positions. Similarly for dinp it's the the same exact thing but one more carbon longers I won't drag you through that whole explanation again. The last issue I want to talk about is screening for phthalates. We've had meetings prior to this about lead and there was a lot of talk we've had even a whole separate meeting about using X-ray fluorescence as a screening tool for lead which you know has been helpful to us and to the to the industry. Unfortunately there's no equivalent screening tool available for testing phthalates. There are some methods that may be promising and may have limitations and we're certainly seeking input if people have good ideas you know we're all ears. Molecular spectroscopy such as FTIR and Raman spectroscopy have limited sensitivity and limited selectivity so they they might show in fact they're they're pretty good at showing the presence of phthalates if there's you know 10% phthalates in something but it won't tell you that it's dinp or dinp or one of many dozens of non-regulated phthalates and they're not so good as you get down to a tenth of a percent is my belief. Pyrolysis gas chromatography mass spectroscopy this is a technique of breaking down long chain polymers and directly injecting the breakdown products into a GCMS. This is promising as well but the the heat of the pyrolysis might pose problems of breaking down some of the long chain phthalates such as dinp or dinp perhaps in the right conditions this might be a good method it should have very low detection limits though it might be difficult to quantify and it's not at all portable. Another technique is direct analysis real-time mass spectrometry again very powerful technique that should be able to detect very low levels but would be more difficult to quantify and again not portable and then the test method ASTM D2124 is an extraction method for extracting phthalates from PVC and then analyzing by FTIR but it's time consuming and it's not portable so if anybody has comments on these or other techniques that might be useful we'd certainly welcome that and with that my chemistry lecture and talker over so I'll pass it back to Mike. Thank you Joel. Okay now we come to the discussion part of today's meeting. Now I mentioned earlier that I want this to be a dialogue between the CPSC staff in the public so we structured the discussion to have two parts first we're going to ask questions of you we have a just a few slides a limited number of questions to try to get your input on the different questions that we raised today and then following that we will open up to the audience for your questions of us. Now we will in responding to questions so we have a portable microphone available and we also have one fixed microphone here on the left side of the room and we ask when you speak that you give your name an affiliation and I think what we'll do is we've been here for about 45 minutes so we'll go for at least another 15 minutes and then we'll take a little break and so now I would like to bring back Celestine Kiss to talk about the definitions of child care articles and so on. Okay well I'm not actually going to talk too much you can see the questions and you heard what I presented a few minutes ago so really it is now we want to hear from you we'd like to get your opinion on what do you think is the staff's approach to determining which products are considered child care articles technically sound does the idea of a primary and a secondary approach seem reasonable is our guidance that we have out is that is that clear do you have any questions about anything that we've put out and are there any classes of products that should be included or excluded and I have I want to point out if you think there's a class that should be included or excluded if you can go into a little detail as to why you feel that go into which category that would help us a lot too so actually what I'm going to do is I'm going to sit down and take notes so if anyone wants to start if you have a question please go to the mic and and start asking questions or or given us information about these areas if you don't ask questions Joel's going to start chemistry again no more chemistry I'm Randy Swart from the Bicycle Helmet Safety Institute if I and this is about your guidance that's on the web right now if I read correctly your CPSI a page for small manufacturers says that sporting goods are exempt is that not correct I was a little surprised to hear you asking the questions today actually because I thought a lot of this had already been settled but and and my concern of course is bicycle helmets are they exempt or are they not and when I read through the guidance for small manufacturers it appeared to me that they are so if you could shed any light on that or take back the the need to shed some light on that I would appreciate it okay well first of all I think it's things like protective equipment helmets and so on are not really toys and therefore they would not be subject to these particular requirements however the proposal that we have out for public comment right now is just that and this is just the first step in a process so everything in in that document is is still open for discussion hi Nate Herman with the travel goods association had a question or two questions first in terms of the primary and secondary products as prior travel goods we have lunch bags plastic lunch bags and it was unclear first of all from the definition that you presented if would be classified as a primary secondary product and the second question along this line if it is classified as a secondary product would it be excluded from from the fallow ban because I'm not sure it was clear if secondary products were excluded or not from the fallow ban okay the way the staff is proposing this is that if if we consider it a secondary product then we're saying it should not be covered under the ban and in terms of a lunch bag or a lunch box or a lunch bag that the parent is using to carry the food and it's not necessarily the child that's using the bag then then I think that would fall under this category of a secondary product what about if the child's going to a daycare preschool and has the bag in their backpack or something like that where probably the the staff at the daycare preschool would probably be most likely handling it but there's a chance that the child could handle it in transit or something like that then that's one that we're going to have to look at specifically and and you know what we're looking for is what's your perspective and why I mean is that a primary or a secondary child care article and then the larger question of travel goods in general backpacks or children's wheelie suitcases uh we when we've submitted comments to the general council in the past that that we don't believe they're they would be classified as as child care articles or children's toys under the definition because they're not being used for play they're being used to carry clothes or or at lunch bags and lunch boxes and so I just wanted to see if there was any consideration on those types of products well I mean the the question that you the main all the manufacturers have to ask is does it is it for play is it to facilitate uh eating sleeping teething and sucking and if the answer to all of those is no then it's not covered thank you and also I I would say that one of the things that could push something into a secondary is how it's used and and when you're talking about the lunch box for again that would be for a child three years and under when we're talking about feeding so a two-year-old that goes to daycare and carries his lunch in his lunchbox the the lunch box isn't facilitating his eating lunch so that's one thing that we could consider when we look at that thank you hello my name is a rick locker i'm general counsel to the toy industry association juvenile product manufacturers association i'm going to i'm going to keep my questions in focus in and trying to answer the questions that celestine raised for this slide which is child care articles so to your question we do believe that your focus on creating primary secondary and multi-use product categories are a good first step the problem with that approach however is that it's only gets you where you partially we believe should be going and let me explain that comment we look at this from an historical perspective both in terms of regulation of these very same articles in europe and around the globe and then even in dealing with the legislation as it was developed in california and then in the united states here in congress and when we looked at this issue from that perspective we we believe that the word facilitate is something more than than just simply make easier we think there's another further analysis that needs to occur which is not just make it easier to sleep feed suck or teeth but also to make it easier to directly result in that activity so that function so a something that is a pacifier for example which is one of your examples up there might be used actually to comfort the child and actually induce sleep so we believe that that would be covered we believe that certain types of articles that are used to actually feed a child which are intended to go into the mouth would clearly be directly related but to the extent that they're even within some of those categories to the extent you had products that were used by a child if it was not actually exposing that child to the substance to the regulated phthalate if it didn't actually go it wasn't intended to go into their mouth you wouldn't actually have exposure no exposure no health risk so the categories were fine as far as they go but we think it needs to go to that next level in terms of defining which products actually directly result in the activity that's being regulated which is the sleeping the feeding the sucking and the teething and so so the cpc actually had done a lot of work as you know and you were there in the past where you looked at this very analysis you you yourselves have done extensive mouthing and observational studies on mouthing behavior of children you've modeled the risk and exposure to children from a variety of products over time and the activities that are involved with children with these products so you have that expertise the categories are fine we just believe it has to go further down into the into the activity so to speak directly related to the activity and in a manner that creates a hazard because let's let's give an example of a child care article that you did raise is another question in europe they don't regulate mattresses right because their position even under their existing a broad-based phthalate regulation because their position isn't the child is not likely to a mouth and ingest the mattress itself which is covered and you're not dealing with you know volatile organic emissions here you're dealing with a hazard that has to directly result from the mouthing the chewing and sucking not licking on the product so thank you i'm wondering about your thoughts about where you're going to go in that direction well we're where we're going to go is begin is we'll begin by analyzing all of the comments that we receive on this as far as the the risk additional risk assessment work goes the chap will be considering these things however the the cpsia is is what it what it is i mean we can only do there's only so much that we could do and i think what you're raising is really more of a policy issue uh that maybe a little bit beyond what we hope to accomplish today but we appreciate your comments hi my name is bob glennon with kit brothers i have a question specifically about sporting goods we sell a line of sporting goods that is not the name brands but what i guess the point is is that our the user is the one that determines whether it's a playground ball or a sporting good because it's in a toy and novelty book doesn't mean it you know we have lots of schools who'll buy a dozen balls to be used in gymnasium so so we i think part of the problem with many of the categories is what is the user going to do with it as opposed to how we intended to sell it now of course we have balls that have let's say you know novelty things on there well yes we even can sit we consider that a toy but a playground ball is not necessarily a toy and i don't know if you want this comment now or i could wait till later in the coming president i think a lot of the issues that that are um we're all presented with has to do with the age determination of this law and i know that you're not the legislator is not blaming you but is the things as this gentleman said that you explained that it's a three-year-old will mouth will mouth a healthy five-year-old will not mount and if you take if you take those products and go back to what we've done for all the 28 years i've been doing this is what is the age appropriateness and if an 11-year-old puts a ball in their mouth and sucks on it or mouths it sticks in their mouth that is not anything that any of us that can stop if it's not used appropriately toys that are using appropriately another comment i and i'm not in the mattress and crib business but i think you're you're in in that case you're making a determination um i believe uh lestine said you have a mattress with a mattress cover and a mattress pad and there i think you're making the assumption that you and i and probably maybe a hundred percent of people in this room would in fact do that when in fact there's a huge population and the people that are most i think affected by the lead and phthalate problem would not be using a mattress cover and a pad and a blanket so i think you know we're looking at a different audience and i you know i think you need to take that in consideration when you consider a mattress but as i say i'm not in that business so thank you thank you hi we're back in monta with the american panel footwear association we've already submitted comments um specifically on bibs and pajamas but we will be resubmitting those comments because they are um they are kind of on the cusp here and just wanted to make some quick comments about pajamas first of all the european union has already exempted pajamas they say that uh from the phallus standard they say that while a child happens to be wearing pajamas while sleeping that does not necessarily make it a child care article and in submitting these comments and researching these comments uh there's a lot of talk about how babies sleep four hours at a time and wake up you know throughout the day so a child may fall asleep in pajamas or in a onesie so i think that's something else to consider and then also i have a question for you and until the cpsc has time to determine whether these products are covered what would a manufacturer do do they continue to manufacture the product if they're unsure whether it's covered by the phallus standard do they test for the phallus or do they kind of hold off and wait well we'd certainly recommend if a manufacturer thinks that their product might be covered that they not include phallus and if they're really not sure you know at at this point we've given the best guidance that we have available at this point um you know beyond that you know we can't make a compliance determination on the spot there some products are going to be very variable depending on the particular design and and and things to that effect the uh EU's interpretations don't necessarily apply in the US again as we've mentioned the laws have differences in their definitions and uh that's that's right until the the certification requirements go into effect the most important thing is do your products contain phthalates and if you are confident that they don't or can test uh then i think that's what you should be doing if they're you know made from natural fibers or so on and then you're confident that they they are phthalate free the uh other the question i have has for you is how can we say to the public that uh pajamas don't facilitate sleep well facilitates to make easier and again a newborn infant sleeps throughout the day regardless of what they're wearing and um i also did some research on how to help a child fall asleep a newborn infant who may be temperamental in sleeping and they mentioned you know you might want to rock the child put it into a a crib or put it into a certain environment dim the lights but not once in any of the books or the internet pages that i saw did anybody mention put the child into pajamas so well i did some to and it talks about putting them into the sleeper blankets um so that they're warm during the night time and um one of the other things that we have to consider is how you're advertising or promoting your product and if you're advertising and promoting your product as pajamas then they are commonly recognized as intended to be used at night time for sleeping and that's where we're also told that we have to consider right and i'll i'll even point out that you know by calling your product uh sleepwear you've you've already uh you know subjected to additional uh flammable fabric requirements that we have for for sleepwear so there's a you know it's hard to say that somebody has gone to the to the effort to call something sleepwear to subject themselves to extra uh requirements and say but we didn't mean for it to be something that helps with sleeping a loungewear is also subject to the flammable fabrics act so we you know there's a wider variety of products that are covered by the ffa and you know again i i think that using the european union as a standard uh not only just with how the what kind of products are covered but the testing methods that go along with the european union standard i think that would be important to consider as businesses have been operating under that and it would just be an easy transition thank you hi my name is carol pollack nelson um an independent safety consultant and um i really wasn't going to offer a lot of comments on this i was very comfortable until rick said something that made me get up and that is that um i think that we can't just look at things that are intended to be placed in the mouth because babies don't really know the difference and i think that what we really have to focus on is the risk and what presents a risk and i know a lot of this is tied up joel with what you're doing um but or maybe not what you're doing but maybe what michael's doing but i think that we need to really stay focused on how does the risk present itself and if it with the very young children they don't know if it's intended to be in their mouth or not they tend to put something in their mouth um if they can do that when they're in that melding phase so i wasn't really going to comment on the specifics and then the only other thing that i would say and this was included in the comments that i submitted the written comments is that there are certain aspects of some of these products that we know from experience and i know that cell you're very familiar with from all of your um tremendous experience and there are certain aspects of certain products like cribs and swings um that are known to be areas that are mouthed and there are other areas that aren't possible to be mouthed like the handles on a stroller that the parent uses so again i i my concern is always just tied to the risk and so those are the only comments that i have um about this slide thank you hi i'm tom parks with easton bell sports and i agree with that uh previous speaker who talked about the safety aspect and think that we're probably not doing a good enough job of emphasizing that that is our primary goal outside of categorization and whatnot our focus has to be on the safety of the kids um i'm i'm concerned as a manufacturer that sometimes we drift away from the practicalities and the realities of what the exposures are within given categories randy uh squirt from the bhsi spoke on bicycle helmets and how we seem to have today very clear guidance that sporting goods are excluded from the phthalate requirements very logically from the safety of our kids standpoint we don't expect kids to mouth a lot of these sporting goods we're the cpsc to come out with a ruling and make that change um for one i don't think it it uh satisfies congress's intent the safety of the kids but secondly there's a huge impact on industry generally and i'm sure that's true with the non sporting goods manufacturers as well the more that you can consider safety first secondly impact on industry and the timing of that were you to come out in a month six months a year and say we've decided we've ruled the sporting goods are toys and must not have these phthalate contents that basically wrecks industry it lays off people were it to satisfy a strict safety need that would be understandable but the impact that you can have with the stroke of a pen when there isn't a safety need is something that has to be critical to your thought process and i advise you to be very sensitive to that impact also sometimes when we don't have clear direction i think the cpsc as a whole is a very reasonable group of people i think industry generally has found the cpsc to be almost if you will surprisingly reasonable on so many things in terms of guidance but if we would expect you to be reasonable in a certain area but we don't get the specific guidance from you some of our customers are then going to interpret the specific law in such a way that we have no choice in other words accessibility issues if we don't get specific guidance i realize that's outside of phthalates if we don't get specific guidance a given retailer could require us to meet the specific law without the reasonableness that the cpsc tends to show so when possible i know you're doing it now i know you're very limited on budget the faqs and whatnot they can give us specific guidance is extremely helpful so that then our retailers who set the rules so often for us on what we can and cannot do have understanding as to what's okay and what isn't i realize that's a bit of a ramble but certainly primarily i'd like you to focus on obviously safety first but secondly the impact on industry and how a simple change in categorization that may seem like kind of an easy thought process for you is hugely impacted on on industry thank you thank you i'll just point out you know again we what we're trying to do is be as proactive as you said and get the guidance out as quickly as we can but we cannot speak for the commission we cannot speak for if a court finds differently than we suggest so we have the choice we could give you no guidance or we can give you the best guidance we can so we're trying to give you the best guidance we can but we're not going to promise that things aren't going to change because i i can't speak for people other than the staff one thing i want to point out is when you talk about sporting goods i mean there's protective equipment helmets and that sort of thing and there's also footballs and in baseballs and that sort of thing i think when we're talking about what maybe should be included or excluded we're talking about baseballs and footballs i don't think we we um protective equipment per se uh has entered into our discussions yet um but i am wondering if there's a you know how what's the likelihood of phthalates being in like a bike helmets and so on in the in the padding or something i don't know if uh you you could answer to that i know our company has moved to eliminate phthalates or bring them into compliance even on our adult helmets just because we recognize that this is a trend that's going on but while it may have been fairly easy for us to do so in bicycle helmets it may be more difficult in a you know a small size football that very much is a sporting goods it's used to improve skill set it's used in competition it's not a traditional toy but it may be far more difficult to remove phthalates in that within bicycle helmets um you know we found it in adhesives rubber o-rings the perimeter strip that that holds the micro shell on but those have been expensive but something that we've been able to uh to bring into compliance whether it's required or not thank you thank you jackie hardwood with the following group um you continuously talk about manufacturing we should be manufacturing to be compliant with these laws but we keep forgetting one major thing inventory all of us still have a lot of inventory that we are holding on to waiting for these rules to be finalized so we know if this goes in landfill or if we're going to be able to sell it and us being a responsible company are taking it as cautiously as we can and we are holding off on doing anything without the guidance of the cpsc for final rules whereas we have competitors who aren't they classify items in whatever category it fits into things aren't toys anymore they fit in another category and it's it's very difficult to um talk to a customer and tell a customer we can't sell you this item any longer we can't sell you ballpoint pens any longer because they're uh well uh yeah we appreciate your comment uh ballpoint pens aren't toys usually so they probably aren't subject to the values yes but we're talking about values today and uh i'll just say you know you can always test your products and meet the requirements and sell your product uh you're looking at at finding where where products may be exempt uh we are we've issued the guidance that we can issue the rules will come when they come in the i mean the inventory issue was decided in we don't have any control over that no no i understand that what i'm what i'm saying is that um we lean towards the cpsc we we appreciate everything we recognize what the cpsc has done i am very much pro cpsc because without some of the rules that have been issued we'd be in a much worse situation as an industry so we recognize that but there is still a huge fear of from companies who don't know what to do and what the next step is and with the four-day reversal on the phthalates which none of us expected um we get cautious and the sporting good clarification what is the sporting good what is the sporting good we care a lot of sporting goods we care a lot of things that are novelties there's probably not a single person in this room would consider a fuzzy handcuff to be for their six-year-old child but there are novelty item and we sell toys and that's a toy that we sell so you know we sit and we wait and i just we're i mean the a toy means children under 12 and under um that's why we're here and that's why we're going to get this guidance out um and hopefully finalized as soon as possible thank you i'm back i'm back i have a couple more questions one is um questions um is there an understanding or can you probably directed to you joel uh as how they phthalate exposure risk is distinct from lead exposure risk and others is lead exposure risk can let let exposure risk we know can be is through touch i believe it can phthalates exposure be be through touch or is it only you know lead phthalates or any other material exposures could be from ingestion from inhalation from uh transdermal there's a number of different ways what are the most common routes and what are the most you know we have lots of of information on that really that's not germane to uh what we're talking about right now the the act the cpsia which is the law is written the way it is and it it bans the the content now the the chap the chronic hazard advisory panel will consider risk in its analysis of the three interim prohibited phthalates um but really that's the only place that that really enters into today's discussion well specifically okay so what happens with a cell phone is that a cell phone that has games in it would that be a toy or would that be is that covered here well i you know i think uh a cell phone is primarily a phone and not a it happens to have games if its primary purpose is a toy like a video game then it's a toy right there's also the question is it primarily intended for children 12 and under most cell phones are not primarily intended for children 12 and under and there's a separate jurisdictional question i'm not sure about that as far as fcc versus that i well i can't address that there's a number of possible jurisdictions but some products can cross over uh i think i want to uh let me just say that uh we're trying to stay on track and want to make sure or say one last call does anyone have any comments on this list of products uh in the definition of child care article um do we want to move on to i i think what we'll do right now i know we have one more we'll take one more question where that's next on the agenda so i think we'll take uh a 15 minute or so break and be back here at 25 to 3 and continue our discussion let me introduce myself i'm j howell director of the office of hazard identification and reduction uh it's it's been a uh an informative meeting thus far i want to take this opportunity to remind the audience that we have a unique opportunity here today with a limited amount of time for the stakeholders to inform the staff and help educate the staff in what approach they may take to the implementation of this particular section of of the cpsia i would encourage you to keep your comments and questions focused on the implementation i know there are many concerns about issues such as inventory which quite frankly on one hand certainly are a policy issue but on the other and i think more importantly is if you can help inform staff into the approach that they're taking an implementation for example i believe this product should be in and this product should be out and these are the reasons i think that they fall within those categories within the parameter of the law as written i believe if we focus on that kind of activity staff will walk away with some good information and a foundation to build upon as they develop an approach to recommend to the commission for implementation of this particular section so we appreciate your comments we hope that you keep them focused on the technical side of implementation and we'll open it back up for additional questions we have one left over from the earlier morning thank you thank you thank you j what we're going to do is we have one final question about the child care articles and then we're going to move on to toys and the astm exclusions so let's proceed my name is jennifer sassan with the natural resources to get defense council in rdc so i'm quick and pointed comments on the question that you've posed first of all thank you for having a public meeting and inviting comments it's a good opportunity i think for us to hear each other as well um and just to um you know though it hardly needs to be stated to remind that there is clear scientific evidence from animal studies that exposures particularly during early life in animal studies do cause or lead to irreversible permanent damage in animals that were exposed to phthalates given that it seems that the intention of the commission's actions are to prevent exposure and by that to protect the public and so our comments on your specific list are as follows um first of all we do believe that all crib and crib materials including mattresses mattress covers and sheets should be subject and that's because they often contain vinyl components that are likely to contain phthalates and there are large surface area children spend time on them and we do know that phthalates can not only cross the skin but also volatilize and are found in dust particles that could be on these materials we also believe secondly that um there should not be exemptions for products such as strollers bouncy seats or swings and that um products that have similar functions such as strollers should be subject to the same standards we also believe that packaging of personal care products for children in the shape of animals or cartoon characters should be subject and that's because they may be played with in and out of the tub and as well they are often made of PVC which may contain phthalates pajamas we also believe should be considered and that's because they not only facilitate sleep but the foot bottoms or um insignias that might be on them are often made of plastic materials and could contain phthalates and in addition we want to clarify that anything that doesn't contain phthalates should clearly if it's clearly phthalate free then it should definitely be exempt from testing requirements well if it's free of phthalates it should be you mean certain materials and right or products if it's clearly phthalate free for example wooden products or products that are made of natural fibers or fabrics okay thank you thank you now we're going to move on to the children's toys and hopefully we will get the slide up on the monitors going to ask are the ASTM exclusions appropriate for section 108 is there a better way to determine what should be considered a toy and are there any classes of products that should be included or excluded from section 108 and again um if if you have a product oh there we go if you have a product that you think should be included or excluded if you could tell us why that would help us a lot thank you okay hi i'm steve murphy with reed smith i've got a couple questions with respect to the f 963 exclusions i have a client that manufactures things like scissors and glue sticks and stickies and rulers and things of that nature which may well fall into the f 963 exclusion for art materials the question then becomes does that fall outside the definition of toy which brings to bear the issue of play um i've posed a couple questions to this effect to the cpsc looking for faqs but um haven't seen anything forthcoming on it it you know raises this interesting nexus between the definition of children's toy uh under 108 and the f 963 exclusions again i'd just like to point out we're we're really looking for your opinion on this what what do you think and why i would think that the of the work that's gone into the astm f 963 exclusions um is ground that the cpsc does not need to retread and that with respect to the art exclusion art material exclusion under f 963 that should be maintained if you bring up the list of f 963 exclusions that might also be helpful we'll we'll get that up do you have specific ones among those that you want to to discuss your materials yeah i mean the the proposal initially uh that's out for comment says uh the f 963 exclusions apply but i think we're we're rethinking that and what we're probably gonna have to do is come up with a scheme such as the scheme for child care articles where we uh classify things as either part of the toy rule or not right and again it would be interesting your your analysis given the wording and the law of how how the cpsia defines a toy and how how a why you would think perhaps or more likely not that a ruler is something used in play that's that's really the dilemma because the cpsia under section 108 gives you only the term use in play and there's no other definition if i recall correctly uh the language that um celestine used was from webster's dictionary um occupy oneself an amusement recreational activity or exercise or activity and that becomes very difficult to define you know for instance is a glue stick that is available to a child that perhaps may have a colorful exterior on it uh is that an art material which falls under the f 963 exception or in fact does it fall under the definition of toy and the hope is and from a lot of clients that i've heard is that the commission can give additional guidance as to what the term play actually means um my recollection of of my children growing up is that uh when you gave them the option to do something uh then that would be play but if they were forced to put together the little thing for third grade art class that was not at all considered play and the use of glue sticks was limited to those things that they had to do not the things that they actually would like to do which basically involve beating each other up but you know other than that if there's any guidance that can be provided it would be very very helpful thank you again i i will point out to everybody to the extent you guys can provide us guidance right now that's uh what we're most looking for thank you hello my name is robert canik i'm with a in-text recreation corp and we uh handle the sales and distribution in the u.s of a line of inflatables above ground pools different items one thing we've run into and we're often looked to by our retailers to provide guidance because we are the uh a large player in this business is one it's the crossover between the toy and then the mouth ability um we view a lot of products in our line as inflatable pool toys are inflatable toys and we are manufacturing all those free of the six phthalates we do manufacture a line of what we call like pool furniture in other words a floating lounge chair in all catalogs our work they're shown with adults they are not primarily marketed toward children they're not marketed as a toy again it's a floating chair and not to be confused with small ride-ons that would have animals that are clearly marketed towards children we have not looked at them as being a toy now we also are part of a uh our manufacturers that we distribute for manufacturer worldwide so we're looking at standards throughout the world and then trying to manufacture a product line that is consistent across all standards the best we can so in some cases we've already gone beyond the rules set forth here and have been for a couple of years for a number of years but i think the clarity because we've had a lot of confusion this year with our retail and our even our largest retailer retail customers coming to us for guidance is that a uh floating chair is not a toy now that's not to say we're manufacturing them with all phalates because we're not but then that kind of crosses over into the mouthability question it's something we don't view as a toy but in a deflated state is mouthable you know that's where i think some of the confusion comes in the other comment i would have is on items that are made to be used with children not not strictly for children many marketed for adults and children but are very large and an example might be a waiting pool though that's two feet deep and ten feet long um again when we there i think the issue question comes up on mouthability we understand that a small inflatable toy could be in a uninflated state with a child and therefore should be manufactured we refer six p free a cut a ten foot long pool which in a deflated state may weigh 45 pounds we have never viewed as having play value in a deflated state and really for a child that would tend to mouth something probably would not even be very available for that child to pick up and put to his mouth definitely could not drag it around from one place to another so that's some positions we've had there again we've tried to be up front on this and really ahead of the whole market and i feel that we have been relative to uh other manufacturers and based on the input we receive from our retail accounts but i think there has still been a great deal of confusion and i also would like to thank the cpsc because i think you have done an admiral job of trying to get ahead of this in the short time since it was enacted thank you hello uh rick locker on behalf of the toy industry association i thought we would address your question directly in terms of the toys and the use of the exclusionary categories in the astmf 963 standard uh certainly our view is to the extent you're prone to myopic statutory reading and uh that the congress in its wisdom is elected to adopt the astmf 963 standard 07 version whole cloth as a mandatory federal regulation with the exception of the flammability annex uh we do believe that our definitions also and it was reflected in the congressional intent that the definitions that provide a basis for exclusion from the category of toys should also be provided of the same weight as is evidenced in that standard and uh and we do make you know distinctions between products based upon uh they're not just their use but also their function so when you raise issue so for all these categories for example we do consider those excluded and not regulated as toys in terms of some of the specific categories of products like the previous speaker mentioned um we would address you know some of those so for example in terms of the inflatables we do believe that there's an enormous array of products out there in the marketplace now that are made of what would you call that what you've called the interim banned uh phthalates that are what we call three p free uh phthalates that are inflatables that uh many of them that have actually mouth pieces that are made of phthalate alternate material itself that are designed for a global marketplace and whether they and we believe that the function of the product and the construction of those materials should govern we believe the language that provides for the exclusion of of product in terms of or the limitation on product that can only be malted and chewed not licked with the five centimeter dimension or less is uh should govern in those cases we believe that some examples provided in the european approach to that make it clear that they they really intended to in many ways regulate product in a use mode which is after it's assembled or blown up whether it's by machine or by person and to measure whether there are protrusion product in that use mode and be malted and chewed but not licked and and and applying that criteria we think that that many inflatable products should be outside the scope of the regulation in terms of the issue related to some of the you know some of the other articles in terms of the toy category we do believe that that there has to be some very serious consideration to excluding a certain you know certain categories the gentleman before mentioned arts and crafts material we we note that there is a safe harbor for those products built into the testing and certification requirement they were excluded in terms of this approach not only because of the existence of other standards but because the fact that those products already go through a toxicological review and we believe that by adopting that exclusion the intention of the congress both as evidence in section 102 on testing and certification and then by carrying forward to the exclusion of the ASTM F 963 standard was really a recognition if we're tacit express recognition in some ways in the tacit recognition as well that those products are regulated from a toxicological perspective and should not be then regulated again so you know for all those reasons we do believe that that is that those are issues that should be considered as part of your consideration of children's toys in terms of the function and the comment that I made on functionality we do recognize the distinction between products that are that are simulations of actual functional products in the real world and and distinguish them from that so for example when we're talking about swim goggles or or even eye gear or helmets in many cases toy items are simulate the real thing but they don't provide the same protection or benefits as a real item and they may not function you know simulated a swim mask may not or a helmet may not function and be sufficient to actually play football in or to provide the types of visual acuity that you would expect in the real thing or the types of impact protection unless it was designed that way like you know with the exception of like a bicycle helmet so we view that we view that the functionally they can be very distinct and when we look at sporting goods we don't we don't look we recognize that there can be differences in sizing there are many sizes of sporting goods related to sports and athletic activity they were specifically excluded from the regulation there was a recognition that those products might come in different sizes and those are regulation sizes that might be used that way but they would not necessarily be toys on the other hand we do recognize that there might be toys that have a more of a play value that are not as directly related to the sport or activity that the sporting goods are related to baseball or football or soccer that might simulate those activities that may be more in the play mode the same thing for costumes goggles we make a distinction or eyewear we make distinction between ones that are simulant and ones that actually function so to us functionality is key in distinguishing between you know play and and and the real thing you know other definitions of toys you know include you know miniatures or simulated products of of real-life products and so that's why function comes into play for us and we believe it would be appropriate to make those a distinguishing points thank you on that on the idea of functionality one of the things that we're concerned about is some of the 963 exemptions like playground equipment in toy kites i think were excluded because not because they're not toys but because they were covered by another ASTM standard but they're they're still toys i mean the functionality is still as a toy and you know that's one of the things i mean we think we're agreement in agreement with what you said on distinguishing between the toy article and the real football although there's going to be some gray areas but but but some of the other exemptions were we're a little more concerned about well you know we we do know that's similar to to the the difference between actual sporting goods and simulated or play or toy sporting good items that there are differences between a playground equipment that that certainly is used by a child but we don't necessarily consider toys yet we do have categories of of play equipment home versions and play equipment that that actually replicate the same function as playground equipment and that do fall within the toy category we do have a lot of a variety in that if you look at that something like a backyard place at a swing set would be a toy or not no we we actually well no but you might have a home variety you might have a blow molded slide that's used in your basement or that can even be used outside that's not necessarily the same thing as the playground equipment i mean obviously we still believe that it's very important for you to to follow the science if you will in and not just the science but not but to apply that in a way that's that's rational which goes back to our comment on on child care articles which is you know we we believe that it's certainly you know toys it was a broader definition but we do believe that when congress enacted the ASTMF 963 standard they they didn't exclude the exclusions those are included so by by direct adoption those are now part of the regulatory structure in terms of child care articles we believe that the narrow construction that we referenced before that that was intended to be narrow but if congress intended to regulate product merely because of use they would have said so they would have said we're restricting phthalates for example and products that can be used for sleeping feeding teething and sucking instead they used a more refined or defined word which we think originated in the european model which was really keyed into a direct relationship again between that product and the function sought so you know under that rationale by the way you might consider a bibb as something that protects clothing not that facilitates feeding right but we're right now on the topic of the the at 963 exclusions now the toy as defined in the in section 108 they did use language used in play you said that they might use language such as used in if they wanted a more general case and the the phthalates are not part of the f 963 standard i mean there is a provision in there for phthalates for one particular phthalate at a higher concentration and one in particular class of products obviously the cpsia went beyond that and regulated six phthalates at a lower concentration right in the stm standard there was regulation of de hp at a three percent value of the product and we do understand that they did go beyond that but you know keep in mind the the toy standard and the adoption of the toy regulation in conjunction with your own mandatory toy regulations where you also have exclusions by the way in the existing mandatory 16c of r 1500 regulations for toys when you read those together that was adopted as a as a separate standalone regulation it wasn't pigeonholed only in the lead provision or only in the phthalate provision so we believe it is accorded equal weight and we think it does provide some a very good guideline particularly when the cpsc staff is as well as your own mandatory regulations and and list of excluded products of what is not considered a toy but still might be considered a children's product in your own own regulations we believe that that provides a good basis and a guideline for you to move ahead on on this on on implementing what is a perhaps not as artfully drafted a regulation as you're faced with they i i have one uh wanted to ask one more question either you or anyone in the audience uh there are also one of the f 963 uh exemptions include bicycles and tricycles uh yet we have all sorts of ride-on toys and even you know the big the plastic tricycles with the big wheels and and so on um and as you mentioned the indoor sort of playground equipment like you might have in your playroom um uh in in these things a lot of them are plastic you can even backyard playground equipment even the big industrial size stuff it's you see more and more plastic uh uh do you or does anyone else have any thoughts on uh these kinds of products because how can you say a tricycle is not a toy well you know this goes back to that difference of of uh fun functionality if you will and there are different categories and different products i mean there there are there are motor motorcycles there are ATVs there are there are variants of those there are motorized vehicles there are toy versions of those right and the power wheels items there are actual full commercial playgrounds then there are other types of home playgrounds and then there then you step down in our category of product there are more of these generally available products that that functionally are equivalent but are very different so we you know we we look at our standard and we rely on our standard and and that's what we use as as the basis unless there's going to be another guidance i i i think it's as good as anything until you clarify the more pressing issue of of layering in um a precondition if you will which is a amoutability or an accessibility amoutability provision and let until you get to that point this is as good as guidance as any as you're going to find and hopefully at one point with the help of or with the expertise of the cpsc staff and perhaps assistance from your congressional liaison offices you will get to the point where you do harmonize with the other standards that do focus in on accessibility and and amoutability as a as a precondition thank you i have a question and a comment about i'm i'm sorry i'm robert edwards from our box in washington i have a comment about products that are labeled as electric toys in compliance for the federal hazardous substances act would the cpsc automatically regard these as toys or would it do its own evaluation because the fhsa doesn't require that they be used by the child when the child plays they're just articles made by the child so i i would give me an example i'm not sure i understand which product you're talking about um well i don't want to give you an exact example but um well take an electric toothbrush i know that's regulated that's a lousy example because it's regulated by the fda but it would be say one in the shape of an animal would be obviously intended for a child it wouldn't be for for use for for play it would be for have a serious use um so would cpsc do its own evaluation regardless of how it was labeled because the fhsa definition of a toy is is wider than that of the cpsi yeah i think our goal is to come up with a guidance so that the manufacturers can look at it and say this is a toy or it's not a toy for this purpose so just because it was labeled electric toy uh in compliance for the fhsa wouldn't necessarily mean uh i'm not sure if it's a part i think the distinction is the part that plugs into the wall uh is i think that's right differently that's something we're going to have to consider and and and you know discuss amongst ourselves i don't think we're going to be able to answer this for you today well that's what i thought but here's the second part if it's if it's a rechargeable item um and say it was generally agreed that the the part that gets recharges a toy what about the charging base and and plug and cable which stays in place on a dresser or a vanity whatever would you have to would you have to test both of them or would you really have to test the part the child might use or might handle i guess i'd again ask you know what's your opinion on my opinion is uh you'd only test the part that the child uses and the charging base would be like any other charging base in the household it wouldn't be wouldn't come under the uh definition of a children's toy do you think that depends on the age range of the product that if it's a product intended for say uh six to twelve year olds would they be more perhaps involved in the doing the recharging and should that enter into the uh thought process um not necessarily not if not if the base just stayed in place all the time and wasn't moved around the house if it just kept in one particular place and the child put it in the charger when it needed to and then took it off when it when it wanted to use the product so my opinion my opinion would be that the the base shouldn't be included and therefore wouldn't need testing even if you had to test the um uh the the main item itself but that's something you'll think about it yes okay i have one other comment since someone brought up um inflatable toys um when they're deflated my opinion is they're not toys because you then they have no play value um just as i've say a blimp is not a mode of transportation when it's deflated since it's terribly useless in this deflated state i think uh uh say a large um pool inflatable pool toy isn't it isn't a toy when it's deflated because the the toy is actually the the item and the air inside it it's only usable as a toy when it's inflated so i my opinion is that it should not be regards a toy in its deflated state i i guess uh the question i have is uh my recollection is that the toys become inflated very quickly and uh frequently and they're often in a semi-inflated state where they might be able to be mouthed um well i suppose it depends on the size of the product too if you're talking about some large raft yeah i'm told we're i think we're talking about smaller things yeah okay thank you hi jennifer sass with nrdc i'm not sure how you're going to go through this so if you're going to do toys and then um facilitating sleeping or something so i thought i'd get my comment in quickly so don't miss the comment period this time um you had some a list of things that you wanted us to think about and so those were my last comments and i won't repeat them but i noticed in your written in your slides and overheads you had added two things i hadn't seen before pacifiers and tethers so i guess my question to you is why is that something that's controversial isn't that clearly something that facilitates sleep it's directly in contact with the young child and clearly marketed for children under three yeah how did that get on this one in confirmation yeah okay i'd like to confirm those three okay thanks hi eric stan cannell gates and some of you uh are not going to be surprised by some of what i say um you know a couple of basic sort of premises here um one is i wanted to agree with with what carol said that the decisions here as much as possible should be driven by risk in part because the costs of testing for phthalates is very high as i'm sure joel understands and for companies who are struggling as they are uh to decide what needs to be tested um some clear line guidance um something we always try to do when i was in compliance try to give simple guidance that people can understand would go a long way toward getting compliance um a couple of things about for like a better thing about the principles for making some of these calls i would agree that some of the things on this list are in fact toys if what you're measuring is play value but there are many things particularly when we're dealing with articles intended for children under three that have play value um and i would say if we're thinking about risk here and we're thinking about phthalates i would agree with our um participant from the n r d c that the risk is for smaller children that the um mouthing behavior is associated with smaller children and although congress has not expressly given you um a nice cut-off age group i would think in terms of defining toys about whether that is is a potential way to go so that you address the actual risk that that might exist and the children who would be most at most at risk because their behaviors in making these definitions um last week i was at the um national school supply show in Dallas whatever the official title is and i walked around there are hundreds and hundreds of exhibitors showing many many many different things ranging from books to posters to various kinds of learning toys and demonstrations many of those products have play value um is that the commission's position that a teaching aid if it's used in a classroom um is something that you consider a toy if it's used not in a classroom but it's still a teaching aid but you can get it at i hate to use the name of of a retailer that's out of business but at a toy retailer that specializes in learning toys is that a toy and i would suggest to you that some of these things that have a primary purpose for um education or some other purpose other than just play in quotes and that are intended for older children should be excluded from the definition um and i think ultimately that makes a good sense for you in terms of where you use your resources on enforcement and it makes good sense for consumers who ultimately will pay those costs of of the testing thank you john o'lachlan from wild gotchill and manji's i represent a number of companies in different industrial sectors both manufacturers importers and and retailers um i would suggest that you not make it more complicated than it needs to be congress clearly distinguished between children's products for purposes of lead and children's toys for purposes of phthalates and it's a subset of children's products um as rick said they adopted a stm 963 for a reason and it is extremely difficult for industry with all the ambiguity and the rapid pace of the compliance deadlines to come to grips with what's covered what's not covered so keep it simple for now you know you're going to have to readdress after the chap you're going to be readdressing feasibility for lead at a lower limit in the future so you'll have another opportunity to decide whether maybe some of these exceptions don't really fall logically within what should be an exception for phthalate purposes but for now you would make everybody's life a lot easier if you just stayed with the astm standard maybe added to some categories of exemptions if people can make the case for that but not pick and choose in this crush right now in the next few months to get the regulation in place then i'm going to leave you with an anecdote um one of my clients makes a product that is what we thought rather clearly a child care article and they were well in advance of the the compliance deadline under the california phthalate law already had lined up suppliers had done conformance testing thought there was no problem in december quality control testing found a phthalate problem at the time we thought it was going to be limited to the california market and a five hundred thousand dollar problem after the court decision it became a nationwide problem and it became a five million dollar problem um what we believe happened is that the compounder had a contaminated tank where they were mixing the products and the what should have been a phthalate compliant you can't really say phthalate free but a phthalate compliant compound was contaminated because of a product they were making for somebody else two or three days before and so there there's no guarantee no matter how good your program is as a manufacturer good the quality control is you're going to occasionally have these problems and it's not because of carelessness and it's not because of anybody trying to get around the law it's just it happens and so the the thought i want to leave you with is even if this is only the 80 solution or the 90 solution it should be good enough it's going to get rid of an awful lot of phthalates and that's what congress wanted i think if if it had not been an enactment of congress and instead the phthalate standard had been a notice and comment rulemaking it wouldn't look the way it looks and i understand you're stuck with the statutory language but don't make it more difficult than it needs to be already let's do the simple for now and reevaluate a couple years down the road thanks thank you hi i'm chris clea with the information technology industry council and we represent electronics manufacturers primarily and you might think about electronics that's led but we got drug into phthalates now apparently as well um kind of two comments and then half comment just the first half thanks for the testing method that provided some nice clarity in terms of what people are looking for and how to look for it there were a lot of issues with people failing electronic components because it had little pieces or just parts that they shouldn't have been looking for and the the testing method definitely cleared that up but one of the biggest problems we keep running into and it's been sort of addressed here before is this the definition of play and how is it play value one of the things that we're kind of looking at are different types of interactions for lack of a better word you know things that children use so that's clearly your children's product but then when is it when does it become a toy are they just using it are they interacting with it or are they playing with it and we're not sure where in this continuum the line is going to be drawn and and you know there there will be a gray area but the tighter we can get that gray area of interaction versus play and are they just sitting there using something and interacting with it or are they actually playing with it the one definition that uh was up that we sort of liked was the the exercise and activity that there's an action involved as opposed to just you know somebody entertaining themselves because there there can be a lot of entertainment and just watching television which is clearly not a toy or other things like that so so somewhere drawing that line where it's clearly play it clear as clear play value and you know at that point pardon at that point we'd be able to look at it whether or not the phthalates would have to be involved and then the other part and this wasn't discussed but it was in the the guidance was and you sort of brought up you know the use of cartoon characters or or devices basically to make it look more appealing to children we think functionality is really the first I have you need to look for a good example my wife has a laptop computer with the mickey mouse on it because she likes mickey mouse so our our opinion is you know the functionalities first and foremost and clearly my kid likes to play with my laptop and tosses it and we have to stop them from doing that but we don't think that that makes it a toy so something you need to look at in terms of whether or not it's a toy is the is that functionality as well so thank you thank you um uh I think what we'll do is we'll take a a couple more uh comments or so on the toys and then we'll move on to the testing issues so next Jackie Hartwick the following group I'd also like to request um similar to what you did with the lead for phthalates and that's an exclusion of specific materials that simply don't contain phthalates no matter what such as paper or plush fabric after testing thousands of pieces of plush we have failed to find phthalates in any of them but we spent the money to test them to make sure um glass rubber from basketballs um the thread of plush and metal doesn't contain phthalates but we continually have to test for them so I'd like to request some uh what we'd like to ask much as in the case of lead we know we receive lots of data from the apparel industry from the printing and publishing industry uh you know if you to the extent that you have information and data that you can provide that shows that certain classes of materials whether they be metals or or wood or things that affect please submit that data and certainly include uh you know the areas where you find the phthalates as well much as in the apparel industry uh for lead told us that they didn't find lead in the fabric that they tested but they did find it in the so-called hard parts the snaps and zippers and buttons we would welcome that how large of a sampling would you like we would welcome all the data you can provide and especially such that it's representative of the market and we'd also welcome uh uh any you know information that others have that show that certain materials do sometimes contain phthalates uh so that we'll know that that's an issue. Bob Johnson with the Child Safety Task Force I would just like to encourage you to try and make this what is can be a very convoluted process as simple as possible by keeping in mind that first of all this is this is interim clearly you're going to be dealing with this issue not just in this precise rulemaking before you but with the chap and after the chap and secondly um encourage you to make it as black and white as possible in this interim time that's why I think the exclusions uh in the ASTM are appropriate and should give some definition to the marketplace and and to parents and parent groups in the marketplace and that really is what I think is is key in this interim period it's an intuitive process um gives them as much stability as you can because clearly no matter what you do things are going to change again over the next couple of years. Hi Don Moffitt um product safety consultant could also work with juvenile product manufacturer um there's two topics I wanted to to just express some ideas on that sort of cross over a couple different areas they're related more to the accessibility as well as the moutable toy components looking at both those I know um the way the language is in law about moutable toys is that it says if any part of the product is moutable then the whole toy is moutable which is something that we're stuck with with congress I'm hoping some of the recent activity in congress where they're talking about actually allowing you guys to go back and rework some of the stuff that maybe wasn't done as well you could relook at the moutable toy aspect if I was to give you an extreme example let's say if we had a five foot square box of some material and it was just a five foot square solid surface that's not a moutable toy you wouldn't have to test any of that to the the second set of phthalates but now if you put a one centimeter protrusion on it now you have to test the entire five foot square toy because it now says that the whole thing is moutable when you look at the european regulation aspect of it you know what they do talk about is that there are the moutable components that would have to comply to it which makes a lot more sense that you attest those parts that can actually go into the mouth which is where the science and the concern is on that so that'd be one thing that if congress does free up the latitude of redefining some of those aspects I definitely expressed some concern doing that the second part is also with the accessibility which I think is one area that cpsc does have the latitude to reinterpret on when you look at europe when you look at the interpretations prior to the september meeting on this regulation everyone pretty much was working under the assumption that it's only the accessible parts that are of concern back in the meeting in september when it was brought up there's all parts of the components and the rationale used on that was because the lead portion specifically says that there's an exclusion for inaccessible parts well therefore congress didn't mean it for the other I could very easily challenge back that since there was no wording in either direction that cpsc could could definitely look at it as well since they obviously excluded components that can't be touched you could just as easily say that for thali's that there is no risk of danger there's no potential risk of exposure for components that are not accessible so why not therefore rule in in that direction I do think that is within the latitude of the current law that you could actually exclude inaccessible parts from that I know that's that's again more of a policy question we're really seeking them the technical issues but we appreciate your comment but that that's why i wanted to bring up though is that while it's sort of a policy it's also a very high concern because let me let me share an example um what one of the speakers had mentioned earlier about an electronic product I had a small toy that I was involved with that you know it's a relatively small toy when we did thali's testing is 7900 dollars to test one single toy and that's with testing it in asia where it's much much cheaper had I tested had it tested here in the us that would have been about 22 000 dollars in order to find out if any of the materials used actually contain thali's that we would have to change there are you know I think the testing method that we've published since addresses that in a in a very cost effective manner and really that's not part of the the cpsia we can't it's really nothing we can talk about right now but but the test measure doesn't if you have a failure now you have to go back and test every single component spend that money that's what that's why i'm challenging a little bit on that just because there are cost ramifications on the accessibility part and and I just appreciate it if cps you could consider that thank you and I think we'll have one more question on the toys hi good afternoon um my name is paul brown I'm with the national research center for women and families and I went through the guidance several times and overall I have several areas where I agree with you and I think you're on the right track for protecting children as a few comments I do want to make on the on the exclusions I think you're absolutely right when you talk about uh sports equipment used as toys and that's pretty that should be subject to the regulations I think that's pretty clear uh as a person that used to have a swimming pool for a number of years in my home I think you're also right about the beach balls and toys uh pool toys that are deflated children definitely will put them in the models and I can tell you from experience that most of the time those those toys are not fully inflated or or they're actually deflated uh as far as functionality I just want to mention that I don't think that should be the main emphasis I mean when you have a shampoo bottle that's shaped like a dinosaur or some other toy a child is not going to discern between that and a regular toy so functionality cannot be the overriding issue there okay thank you thank you um should we move on to the test methods and let me put up some those questions okay and I think this is our last slide is to uh talk about some issues relating to testing which we've kind of already moved toward anyway um and the slide does bring up a few questions in particular about component testing a toy versus parts which we were just touching on uh accessibility composite testing and as as we've also already touched on are there materials or components that should not require testing and and again when we we're asking that we mean based on evidence that they don't contain phthalates for instance if metals are heated to temperatures above which the phthalates wouldn't survive the processing is that a reason why or you know are there examples and testing data that can show why these are not uh items that should be tested or the contrary so do we have any comments or uh questions about these uh testing issues I mean we touched a little bit of on things like uh the materials and and uh accessibility and and so on is there does anyone have anything else to add on that and if not um uh as let's uh in the meeting by just opening up are there any questions that we could uh answer try to answer for you but again you know in in terms especially of of things that that can really contribute to our knowledge and and you know the the substance of what we have some control over and we're not trying to open this up to a discussion of what should have been could have been would have been yeah hi uh Sanjeev Gandhi from SCS uh I just want to support some of the comments made earlier about the risk-based approach and and that would definitely support the issue of consideration for accessibility of the components in a complex product and many of the electronic components products electronic toys would certainly fall under that category where accessibility of the parts underlying parts components can make a difference and in terms of the testing method component testing uh the way the uh staff method is currently written in terms of its sample preparation process it basically you know grinds up everything to a homogeneous mass of powder material uh through whatever technique is possible and but that in my view tends to kind of defeat the purpose of the intent of the law of making their products safe if you take the example of a crib with it uh teething rail and in that case do we test the whole crib and uh base the results based on the whole mass of the crib or you want a simpler product like a sippy cup where you have uh a soft material which is the part that is actually mouths and then they have rigid rigid plastics and other components and based on that the part that may possibly be very high in in talent content but the product may still pass the requirements and uh so whether that is consistent with the intent of the law that the product be free of those banned talents so these are some of the comments I just want to share with the staff thank you hello Bill Goodman with Perkin Elmer um I had kind of a question and then a follow-on comment um it's kind of my interpretation the test method is that you've presented the method that you were using that you have found to be quite useful um and then the question that I'm getting from others in terms of technical advice is we've been doing this testing for 18 months our method is different um than the method that the cpsc has presented um and I'm sure you know the folks at sgs have run into this um what should we do should we continue with our method which we have validated or um you know should we change and the way the way I've read through it um looking at it scientifically is that if you've got a method and you've got data that shows that your method works it's been validated to a reasonable degree is that they're my interpretation is that there is flexibility in the method to do it you know with reasonable scientific evidence um my advice is that if there's a possibility of maybe making it a bit more explicit in the method in the way the sop is written or was it your intent to um make it so that people really should follow that method um you know my so my question is was that the intent to make it that that's the method that's the be all end all and if it's not you know my recommendation is to you know there's certain portions of the method you know there's a specific section versus must and it's underlined and there's a little bit of wording that really makes it seem like this is the be all end all well I will address this uh it's a more complicated answer than just one or the other at this point we do not require uh third party accreditation uh testing by any particular method uh we weren't even set to do that until June apart from even the uh state of enforcement uh so no no rule has been passed saying what the method would be for accredited uh third party testing uh in some cases though where we have passed rules for accredited third party testing such as for um lead in children's metal jewelry uh we did specify a test method and you know it's an important consideration that we the we have already passed well that we need to pass rules for accreditation and for a for an accrediting body to accredit a laboratory we need to know what they're accrediting them to and not just any old test for there are certainly many different things that one could do to measure phthalates and we wouldn't want one to be measuring a and uh solubility of phthalate from the product when the law is based on the total phthalate content for instance um we're welcoming comments on the method for uh other parts as I mentioned that could be added perhaps explicitly into the methods to give for instance an option for an LCMS methodology in addition to the methods that we've uh given out so far as guidance we may take away some of the methods that we've given as guidance if we get comments that that method's no good that's not going to work um none of this is required as yet they're merely uh provided as a reasonable testing program to assist firms in in meeting at this point okay great thank you I would also add if you have a test method that you have validated that you if you can submit it to us so that we can review it and make be possibly use that too right but I what I'm not going to promise is that the staff will consider hundreds of different methods we simply don't have the staff time and resources to do that we we we may consider a a certain methods and we will make them available to the to the public we're not going to allow a private submission from each and every test lab that our lab wants to do it this way but keep it secret and this other lab you know there are hundreds and hundreds of labs already accredited by the agent well with the accreditation already recognized by this agency for for other test methods we that's that's simply not feasible but we will certainly entertain uh whether submitted just independently for us to publish or or whether by a uh some sort of a group effort uh peer reviewed in a journal anything to that effect we will consider it we may or may not uh accept it great thank you okay are there any other questions um let me just uh remind oh one more now okay uh joe uh you alluded to the issue of interference from some non-band plasticizers types of phthalates that give the same chemical signature if you will as some of the band phthalates uh going forward in future when cpsc eventually does publish a method which would be uh for third-party testing are you going to include some guidance on the kind of signature or the iron selection criteria that is coming from these non-band alternative plasticizers that are being used just to further elaborate on that like we at the test lab have encountered such issues and we have reached out to some of the manufacturers you know that do manufacture and are being used and uh some of them have been kind enough to share the data with us to tell us how to differentiate their plasticizer from others but uh it's not forthcoming from others that kind of information so it would be helpful uh and uh i think fruitful for have that kind of information in the cpsc method so the method is uh it complete in a sense that it can give unambiguous results that all the band phthalates are indeed not present as based on the determination of using cpsc method uh i think that's a good point uh and and to give an example uh there are some linear nine uh carbon length uh phthalates that would look very similar to the branched nine carbon length phthalates but are clearly not part of the the act um and they may elute at slightly different times the chromatograms and the uh both the ion chromatograms and the the chromatographs uh may appear slightly different and uh we we would welcome comments from the test labs as to certain qualifiers uh that would be helpful and we will certainly try and elucidate that as well but this is a an important issue because there's some some different chemicals look similar and then yes we would welcome we welcome that information and we'll we will try and include as as good methods of qualitatively identifying the quantified uh material as we can okay thank you um and well let me thank you all for coming today uh i think this has been a very helpful meeting and um we appreciate your comments i'd like to remind you that our proposal for the definitions of child care article and toy and so on uh is open for comment comment until March 25th the laboratory test method is also open for comment and we encourage you uh to submit comments uh there it's your chance as we said earlier to help us get uh do this in the best possible way and uh to keep our guidance as uh clear and simple as possible and to the extent that your comments give us uh helpful uh constructive information uh that will help us uh even more as we uh go on in our work of implementing the cpsia so uh again thank you all for coming and have a safe trip home