 Good morning, and welcome back to the seventh chap meeting Just repeat the Message that this is a public meeting. It's being webcast and recorded Bill Okay, I wanted to talk about the schedule for the rest of our Existence as a chap Here we are February 17th chap 8 coming to a conclusion And we're getting down to the point where we're putting together the report and I think we're making great progress My thought was that And we attentively said we were going to have something for the external reviewers by March 1st I think that's now not realistic particularly given The fact that burn is not able to be with us So I my thought was If if we gave ourselves as a committee another month to Do the revisions to do the additional writing assignments? Is that is that sufficient first? and then If we Got those documents together the revisions and the additional writings We could share those by email or we could if Necessary have another chap discuss issues But the idea would be then to have a report ready for the external reviewers by April 15th and then they would have a month To do their review and return it to us by by May 15th And the idea would be for us and again This would be I think by email to respond to those Reviewers comments. I think we could do this by email All did that by track changes To Mike we should be able to to finalize the document and again If if there were issues that were so Important that we needed to meet as a group. I guess we could do that, but yeah The goal would be then to have a report to see a CPSC by June 15th This this sounds very sensible to me and I I think I would say personally I can Can we be explicit the the deadline the original one for getting the material to the peer reviewers was first of March So you're suggesting to put this back to 1st of April Back April 15th April 15th. Yes. Yeah April 15th to send out to get it ready for the reviewers to yeah fine. Yeah, lovely. Thank you that also takes that out Beyond the SOT meeting so that doesn't Interfere with their review Yes, I know some of them are going to that meeting and you're saying that we wouldn't get together again unless need be and that would be Hey well We could get together before we send out the report to the reviewers if it was felt necessary Do you think at this point? Given where we are today that we would need another chat meeting before we send out the report to the reviewers I don't feel that we would need that I Agree with you Phil. I think we can do it by email. Yeah, that's my sense Very much more efficient user then we can reserve judgment. We may need need another one after after yeah I would be much more inclined in the rest of the reviewers. Yeah, because we may get some real Interesting comments and we don't know to debate them. I I agree with that plan. Okay What happened? Okay, I'll I'll send out an email with that schedule then to you. Oh, okay So what well, let's can we just? Capture that a little bit. We have it to the peer review. Okay March 17th then revisions And all writing assignments would be due to you that would that would be March 17th 17th, okay, and then the peer review and then those would be distributed to everyone and then a final I Guess a penultimate. Yeah draft would be put together and Circulated among us we do final edits and of a report would go out to the reviewers April 15th. Okay Back back me if there's the high schools protesting side They have Haunt signs that say honk if you want peace If you if you don't be silent the May 15th the report would go to the review or come back from the reviewers and then we would have a month to Respond to the reviewers and put together the final report That's good. And now that's going to require from me than a letter to you I think yeah That's what I'm told is is a letter from the chairman Asking for a An extension, okay Any questions or comments about this? Schedule hearing none then let us proceed with the recommendations for the phthalate substitutes and Mike are we going to have hard copies or we just want to work from the hard copies are coming Shortly, okay, so we'll start with okay this reading from the screen Hey, and the first one is TX IV So again these we just have summary reports for these correct, right? Well, there are toxicity reviews for all of the Okay, this one was prepared by us The other five were prepared by Versar Well, that is Difficult these studies are not published There's no way to examine their quality and there's this ominous sentence that changes an epididymal and to sickle sperm counts We're reported by the authors, but considered not to be adverse Well, this is in one of those study. It's in the category of we don't have the actual study We have a summary I'm worse yet. It's high exposure And well I don't know if you're ready to scroll down yet, but TX IV was we found it in a fair number of the toys that we tested It's not a plasticizer exactly, it's a I think it's used to reduce the viscosity But it's it's present in a lot of things. It's it's found a lot of products. It's found in indoor air So there there are exposures other than from toys Other than that, we really don't know anything about its potential toxicity. Well, let's look at this part so this material is in a variety of locations for exposure, but we don't have enough data to talk about the weight of evidence or The true hazard of this combat. No, and you know this statement, this is This is a you know, it's a drafted. I don't think this is yet the chap's wording So what's written there under a experimental design seems to suggest that our Series deficiencies in these easement studies if I understand this correctly What does GL mean as reported in the GL GL is guideline GLP, I guess Yeah, the OECD that's guideline. Yeah, all right. So this is not a comment on the easement studies. It's a comment on Guideline 421. Yeah, and actually I think this is from this might be from something burn rope That actually could it sounds like something he would yeah put in there Limited information on toxicity. We have limited information on exposure both from the External side and we have no information from Internal exposures so we can't make a determination or anything at this point in time Yeah, and as it says here that You know it's been found in well, it says 50% of living or you know living rooms and bedrooms I'm not sure if that of that. That's maybe dust particles. Yeah dust I know we found we found it Here and we were studying something else. I mean TX IB was there in in indoor air I think it was So, you know, there are other sources. I think it's used in paints or something other kinds of products And we did see it in a fair number of the of the toys I think more more than I expected Remind me again the gestation days that are important this says 21 to 23 days that too late Well spotted that's too late. Yeah At this point, we just don't have any information Well, it's too late for or not the right period for anti-andrena effect. It's appropriate for other Developmental landmarks but not and I'm not sure these were probably done a while back Then you see from the chemical structure or the identity of the chemical We have to Broaden our mind here. It's not necessarily We expect anti-andrena effect that could be anything. It's it's yeah, I mean, it's not a it's who knows. It's not a phthalate Well or say that Can't say something. Yeah, I don't think we can't but I really would like to complain I mean, okay. We're saying it's not a phthalate. We're saying it is a phthalate substitute In air dust So we all expose it and we don't know anything about it. We're gonna find some more of that this morning, too So, but the point is I Hate to just say oh, we can't say anything about it if we could It's really frustrating Let's go stepwise. Let's do the part C first and then we can Go on so regarding risk we could say Unknown unquantified Obviously, there is an exposure, right? Well, we don't know if it's high we just know it's exposure is there but not 60% of bedrooms But that could be a little bit of stuff in 60% of bed And it's little and we don't know what the end point health endpoint to compare that to have to assume Assume exposures It's the incidence of exposure. Well, we know we know the incidence is there Prevalence I'd say it's better. All right. We don't know the incidence. We just know the prevalence Prevalent, but we don't know whether it's high whether it's low whether it's transient whether it's Consistent it's just like with the toxicology. We don't have enough information to make a judgment on either the hazard or the exposure to Quantifier risk. We have neither model data. No nor biomonitoring data to quantify On that basis, what can we recommend? We can recommend nothing. We can't recommend anything Maybe we should say that and then add a clause saying that That does not mean an endorsement of this substance for use in toys I don't know what can we say it says that we need to have tests done to before Things like this happened. I mean, why the hell are we dealing with this after the fact again? You know, we've looked at what? 15 14 substances some of which are banned some which are not banned all of which are come to our attention because they were in products and We have to make a decision the fact that there is no pre-todic testing for exposure Before you put this into into commerce is to me negligence and I don't know whose claim it is It's a DPA is an industry. I have no clue, but it is not the right way to go I couldn't agree more, but what's open to us in terms of options? Can we Can we recommend testing? Oh, I don't know It was in our remit We had some we had some verbiage for some of the ethalates in terms of what? Thank you You could put it very clearly the chaps on the chap is unable to make a recommendation due to the lack of published information or data on peer reviewed peer reviewed on exposure and hazard Yes, but that and then there'd be another sentence after that in terms of I think we had somewhere with one of the other thales I think we had some verbiage that did follow that in terms of because if you just say chap is unable to come to any Assessment then you know some people might say thank God for that. That's right No, no, but I'm able to because of the lack of the data and then you can go on and write another sentence or two Well, the sentence should be basically this is that this doesn't mean that there's an endorsement of this chemical We're saying that the appropriate organizations have to Now conduct the toxicity and exposure assessments to ensure that this would be safe in children's toys or it's a lot of different toys. Yeah before or either before or Maintained I don't know. I don't know if it is in children's toys one concrete thing that the Commission can do is I Mean, it's very simple. We can nominate it to the NTP for testing But the first thing that they will ask is if it is it a commercial product in you know If is there a possibility that the manufacturer would do these testing? I mean You know, they won't test something if they think that the there's a likelihood that the manufacturer will or The NTP is or something that NTP is only part of the issue because that deals with the hazard side Yeah, we have no idea what the exposure issue is at this point. We know that there's prevalence We don't the presulence is it? This level or at that level and whether we are doing with de minimis exposures and then de minimis risk or We're dealing with something that may have a quantifiable outcome We basically may have an unintended consequence situation where we may have a you know No consequence situation, but we don't have the data to prove it one way or the other If any idea whether our previous recommendation might have an influence on future exposure levels for the substance might we You have no idea Are you asking so based on our recommendations on the other chemicals? Is this chemical going to be used in substitution? We don't know what the plan is what it would substitute for you don't even know because as Mike said obviously it's not It's primary use is not as a plasticizer, but there's something like a gelating agent or well I they call it some sort of a an additive or modifier I think someone told me it's it reduces the viscosity and Especially in products where you need fine details and I think possibly as they're going to Different kinds of plasticizers. Maybe they need this to make the other plasticizers work and there might be some you know The manufacturer probably tell us more about it some of the the technical people we could we can ask The point you're just made is reasonable. It's just that we don't have enough information to decide How to proceed on the substance? It's not that I'm Saying that substance is bad or not bad. It's just that without information. We don't know how to deal with it somebody want to start coming up with Some text for the risk We did that but we need to start putting it on the screen something like Expo assume assume exposes What would you put it in birds? I think you do have um Those your data It's a true in general that children that toddlers are exposed to chemicals that are in dust more than other Because they're down in the floor playing around we call them the rug rats So the children are at the most risk of chemicals like this that are present in I mean I've proven that I've done what? Multiple studies on that issue and demonstrated clearly that the rug rats are highest risk to Materials that a deposit in the rug for two reasons one the rug is a great reservoir It's a great reservoir for everything from peanut butter and jelly to other materials. Is there a multiplier? Can you say it's twice as the exposures twice as high ten times as high? It depends upon how long the material has been in there like if you have a Material has been there a long long time you can have very large quantities and it's been a short period time small quantities In other cases, you know, that's can you give a rain roughly? It can be a factor of two to twenty You know, it's it's just depends upon the chemical lead is our classic example where it can be astronomical because of the fact that it's In places where we find lead paint, you know flaking off of walls and tracking in lead paint from yards and street dust You clearly get a high concentration So why don't we let our children be the guinea pigs on this? I mean this is outrageous to me the company needs to hold be responsible to show toxicity data for these chemicals Well an EPA knows all about these dusts. So where are they in this all this? I mean, it's it's it's a multitude of of errors here This is the migration data that we have for The plasticizers that we found in toys I mean, this is Tx I be it's it's generally present at lower levels than the other phthalates, but you can see the curve of of This is the plasticizer concentration down here in the migration rate the curve the curve is steeper But it's the migration rates are about the same because it's usually It's always present within other plasticizer But we have data for Tx I be ATBC Dinch and DEHT the pterothalate DHT is the is a an isomer of DEHP Now if can you see that? Sorry, I'm slow Mike explain to me the migration you're saying into saliva. Is that what? Well, this is a This is migration into simulated saliva using a test that was developed By the European Commission It's a simulation. It's a simulation, but this is used to estimate exposure from outing Toys teeters and toys that kind of thing and so this is this is dinp And Dinch is very similar These others are a little bit higher But overall But it's of course depends on concentration and overall the I mean the absolute magnitude of the migration is probably about the same For Tx I be is the others Because it's not used alone You know it shows that my Exposure from outing does occur and that we can estimate the magnitude of that exposure But what we don't you know, but really in that case what's lacking is the hazard information and this is Just a pie chart. I mean Tx I be was present in you know, say 15% of the things that we tested just a Sort of a grab sample But this is what we have essentially on exposure For the substitutes when was this done Mike? This was done in 2010 He actually got these samples a month or two before the new regulations went into effect We were going to do a for before and after but I Mean there was only two Phthalates that we saw so we didn't ever follow it up And of those two phthalates one of them Is actually allowed because it's it was a toy that can't fit in the dinp is in a bigger rubber ball And it will can't fit in the kids mouth. Yeah, which is fine understandable and the DEHP was some I Some kind of toy that Or some product that at the time I guess in the pasty it was outside the scope of the products that we were considering There any way to get more information from Eastman chemical about this 2001 study Where they say that they observed Yeah, well, I think it's the similar situation with Dinch is The they have the data. They're willing to share it, but they don't want it to become public is my understanding. I think it's it's essentially in the same boat as those other chemicals and You know the chap talked about this at the early meetings in about Transparency and so on and it's you know, it's a decision So, you know, if you look at the FDA model of companies coming and showing data, I mean, that's all Kept confidential. Yes, at least there's a regulatory Agency involved in reviewing the data. I mean could could a process like that be recommended by chap Maybe that's pie in the sky but to have more transparency between the regulator and the company Otherwise, it's not a I mean, I know that's a big deal, but this is ridiculous to let this just go on and on Especially with our children I Do think that the issue needs an airing with all parties involved to come up with a I'd say a logical plan of action so that one the public doesn't feel it's at risk to The industry feels it's got a fair hearing to get things done and three we the scientists can sit and Evaluate the data in such a way that we can come up with more concrete conclusions at times rather than being in the position We are today. This is a much broader issue than just what we're dealing with today It's a very major realize that I realize that but I'm what I'm trying to say is You know, it's not acceptable to me for this to keep going on like this If the if the company's doing studies, we have no way of evaluating the quality of the studies But and in my ranking I would much prefer them having the opportunity to come talk to a regulating body Then for us to have transparency Right. Well, I'm obviously the model is different for things like drugs in Drugs and pesticides. It's a very different model in In that case the government couldn't demand a whole list of studies and They have control over that but the data are kept confidential and that's one model I mean the way we've always done it here is to have it all public, but obviously There are disadvantages to that and You know this this proceeding is not a routine regulatory process like a Pesticide registration or something like that this kind of a process maybe does need to be much more transparent than like something like reach registration or or you know, Tosca Notice, I mean, it's it's a complicated issue. I think it is broader. It's a lot broader than the chap in just CPSC and I Don't know the answers or the best way to do do this but I think The we have I Don't think there's a An overarching system. I Mean we have the different agencies and the different responsibilities Well, I would propose that we write in as strong as language as possible in our report a recommendation for some sort of a change in process and You know lobby that to Congress because it's ridiculous that this keeps going on and on Environmental chemicals are here to stay and we need to have regulatory You know Assessment at that Yeah, I would suggest I mean I think you're all agreeing that we go back and draft some text Recommendation section. I just already did for the broader scope stuff from yesterday from You know uncertainty and gaps and all this stuff is captured in it I just more forcefully added a few more words to deal with Chris's comments Because I think we need of course Pathetically another way of doing this but I don't know whether we're overstepping our mark But hypothetically we could say an interim ban until Data are provided. I don't think I would do it. It's a stimulus. It's an incentive. I Don't think it would hold up Hold up. What nobody's gonna be a It just hangs up. I Don't want to look foolish to make a point, but we're only making a point recommendations on Paul We're only making recommendations. I mean CPSC is the one that's gonna make the decision to either go with that recommendation or not But we have to have a reason to say we're gonna we're gonna give it. I mean Being unknown doesn't necessarily mean it's a reason. It's could be a reason Oh, that's not the reason the reason is the lack of data and the fact there has to be data before We can make a decision and until that time there has to be a Ban Problem is though. We like our plastics. Yeah, you know, I you know, so I don't want to get rid of all You know, I like the things I have that are plastic But I also don't want my children exposed to this crap and that's the bottom line If it's bad stuff get rid of it, you know, if it's good stuff show us it's good Right, but I don't want to end up in the courts with somebody saying well It's good versus bad and then the whole concept of what we want to have done is lost All right, that's the problem I see if we want a concept you yourself pointed out We're practically dealing with the situation where to use this analogy where someone starts Flying an aeroplane takes off and the airport at the other end isn't built yet So Got clever pilots I Don't know. I don't have any answer to this It's something that's it's we've struggled with for years because Tosca doesn't cover this issue either covers raw chemicals and It's a it's a conundrum But looking at this data given here Yeah, I think we have to be aware that the exposure the relevant exposure for the children and the pregnant mothers might be higher To these substances than the satellites we investigated yesterday, but we don't know if it's in kids toys Obviously, it's there No, it's in the dust. No, it's it's in toys. I know it's in the toys, but Probably what I think the data does show it's there. I mean if you're not using a b and c and now you're using x y and z so Now we have yesterday we said most of the satellites are not relevant for toys now We have the case that these substances are obviously of relevance for toys. I don't know how to deal with this Don't we know we don't have enough data there the kind of thing we would I maybe it's too late in the game to even entertain this thought but is this the kind of thing where we could request information more information from Eastman To review and if it's not up to our you know If we can't get enough information from that then we would ban it. Well, I think in concert for practical Reasons, I mean, I I don't know some of these studies can be very voluminous. So at this time Depending on how many pages there are it it might be too late for that And it's the issue. I think you know it we've had the same Discussions with BASF and they're willing to share the data As long as it's kept confidential. I mean, they're they're open to To something like that and they have been but it's but it wouldn't It likely would not be public The actual studies probably would not be public Obviously it is it is to do with a with a structural or systemic problem here in the legislation and I Mean what I what I've floated Hypothetically this idea of of proposing an interim ban in these cases may indeed look out of place in the sense that here the chap tail tries to Wiggle the entire big dog of that big problem. Yeah, it may indeed look out of place, but yeah I think I don't know what you think about that. I Think if we make a strong statement about the need for research bold flashing lights neon lights I Think it I think it would get enough attention Yeah, well it will be it without any consequence. Yeah, it's just it kicks it down the road We've said it blah blah blah. I mean, that's what we don't know what we're kicking down the road That's the issue where we kicking down the road something that is a serious problem or a non problem I mean, I don't want to be in a position where two years from now. They should becomes a non-probable problem and then We've kicked something down the road, which we shouldn't even touched Well, just I mean Tosca reform I think has been on Congress's agenda for the last couple of Congress's and you know, it's it's a huge It would be a huge undertaking What about if we ask if Phil could go talk to Congress No, I think it's a bit But it is a much bigger much broader I mean that the scope of this chap is incredibly broad and But to talk about these kinds of issues is is is much broader and much higher You know in clearly when when Congress gave us this mandate there was great concern about phthalates and by extension that the substitutes they wanted us to look at everything and Yeah, what is the the most effective way that we as a committee can Transmit our concern Concerns if we have any to them Is it by just saying that For this kind of a chemical that we have concerns because we can't interpret the significance of the limited data we have and we're very concerned about the fact that there's a lack of critical data that we need to make a Informed decision and that's all we say or do we want to buttress that by saying Because of that we feel we have to recommend interim ban until Those concerns are addressed That's that's that's the question we have to answer I could relate to that But that and that puts the burden on the companies which may be where it should be But I think that I think what's we're really seeing is the process is broken. It needs to be reformed and and that's not Just the company's problem. That's the whole just the system. Yeah, that's the system Maybe it would look out of place if these were sort of small potato chemicals But some of them are really high production volume things It's not small potatoes true. I don't know which will give us more realistic attention If we propose a band and then it just goes on the lament about the Tosca reform Etc. Etc. It feels a little like barking at the moon. I'm not sure I wouldn't want to put that in I'm not suggesting to to put that in but but a lot of the comments that were made I mean, I can't detect a political will here to reform Tosca at the moment So it is a little feels like barking at the moon So I to Phillips way of looking at it the only option open to us if we take This responsibly is to indeed say interim bands until data are available I have the option of For some of these chemicals not having the the transparency Can we can we I mean, it's up to the chap You discuss this at the First couple of meetings, especially I think the second meeting way back. Yeah, and you know, it's it's really It's up to you Seems to me we have a small wind of opportunity That you know with at least a threat of a band we might have an opportunity to communicate with the different manufacturers and What we see we're not happy with in terms of toxicity then we'll know what but if the chemical is in fact Safe enough I'm reluctant. I Really am because I don't know what I haven't got a plan of action beyond it And I don't know what we're what where the landmines are at all or even to consider a Set of steps next steps if we recommend it But the case as put by Chris and by Phil Well, there is some the arguments carry some force these are high production volume chemicals So if you're uncomfortable with this, can you put some rational arguments on the table? Why? you're uncomfortable or Is it just a feeling and just a feeling I had emotion Hmm It's hard. It's hard to quantify. I mean the point is is that it's There are so many other issues beyond this chap that one has to deal with in this particular case regulations of other agencies there are other other regulatory bodies, there's The whole process of how one Get things to market which are so confusing when you're dealing with consumer products that I don't really Don't really feel that I have enough Background put to make an intellectual decision at this point But we're not tasked with that our charge is to make recommendations in terms of actions and bands and term bands and What goes on after our reports written and the processes and market forces and industry etc. Is Not something we can control or something that's in our charge to consider We're to consider exposure hazard risk exactly Make a decision seems to me the worst thing is if these products get into high volume, you know Continue in high-volume production and our children are at risk. I mean that's It may be an opportunity maybe to see what we're dealing with maybe but I think we should narrow down what what our charge is Which is what we did yesterday. We went through, you know exposure hazard risk make a recommendation Realizing that it's really complex as as Paul was mentioning, you know what if we do make it, you know a recommendation for an interim ban there's There's no other alternatives potentially to replace these chemicals So nothing may happen or You know, whatever in terms of you know the Congress's view or industry's view, but I think we should ignore that and focus on What our charge is and what we're asked to do in terms of where our expertise is it's not in understanding Congress or Tosca reform etc. But it's hazard exposure risk make a recommendation Because I think if we try to Couch what our recommendations are and then think about how it's going to be used or the political system, you know, etc We we can't predict that and we Probably shouldn't be doing that as scientists. We should be focusing on the data at hand. So For the lack of data at hand and that in this case, yes you'd be comfortable with That approach in terms of how we Make our recommendations That's always the best approach it's just right now I I'm I'm struggling with Recommendation banning interim ban at this point because I'm so it's terrible. There's so little information that's that's not anything that I Is part of our That we can respond to I mean we don't control that Part of our charge or right? You know it's like Hypotheticals and you know to almost be like, you know, we were invited as an expert panel to to review These chemicals and this is all completely hypothetical may sound ridiculous But you know in terms of hazard exposure risk and we were asked to do this in You know a Vacuum a system, you know another country or another civilization where we have we shouldn't have any regard for What's next in terms of how that data is used, but we're just asked to focus on The science the the data or the lack of data and the hazard exposure in rest. All right, let me I'm willing to compromise. I'm willing to go to the issue that we could propose This but if the Commission is not what you mean by this This idea of proposing an interim ban All right I'm willing to do that as long as something's written in the proviso as a proviso that if in fact the Commission doesn't Agree with the need or the desire to have this interim ban. They must They must ensure that data is collected before the next time a chap is Convened on these issues to ensure that the data is available to make an adequate risk assessment I'm willing to go for a band But I need to have that other statement because I just don't want it to sit there Yeah, but I mean again, I think we can recommend that but the word must I mean, I don't think we have that We're recommending an interim ban because there's no data, right? We can't say that they must Initiate an interim ban we can just recommend that they do and we can recommend as well that they Do what you ask but we can't all right the words the wording We'll wordsmith it But if you're willing to do it with those two concepts in mind I'm willing to do it I think that's perfectly reasonable, and then we've done that Same thing in our wording for some of the other phthalates as I remember But we encourage the relevant agencies to Why don't we try to but this is much just be much stronger put it on because there is a total lack of data Mike can we go up to one of the phthalates where we recommended an interim ban, but we also asked Me a statement to the effect that we encourage the relevant agencies to George's second Can't remember the weight wording. I think we also have to consider that we have to be consistent with With the approaches for some of the other phthalates we discussed yesterday like DNOP and DIDP because looking at The data apart from the anti-antigenic effect we don't have much more data for these substances either and We kind of said well, they are out of this window of activity. So There's minimal reason for concern in this respect here Inside the window The question we don't know But we don't have much other data for the other delights like the IDP and DNOP So we have to be consistent with the approach we we go, but I think what Chris said before it's important is that here. There's is exposure And there's only other instance that weren't so I don't see that it's equivalent Here there is an exposure But we don't know we have to assume the same exposure when we lift the ban for these substances So in a couple of years time It might be DIDP and DNOP again on the on the list In the pie chart. Yes. It was the one before that. I think all go what you're saying is in terms of the the hazard the The requirements or what we an interim ban discussed yesterday Relevant and consistent statement about Courage the relevant agencies to Give me a headache. I would propose that I would propose that also have a look what we wrote for DNOP and DIDP What just for consistency check Because that's go to issue Well, I think the immediate difference that leaps to the eye here is that a couple of these substances indeed Are not currently used in toys and that's a big difference. That's the point. I was making But if you propose to lift the interim ban, they can be used again We have the same situation as for the substitutes. We are talking about a day Yeah, and the recommendation for this one was was tending very differently from the one we're Contemplating here, which was the last sentence is however There is no evidence for of anti-antitraining effects observed with some other fillings Holger are you suggesting that we're better to deal with chemicals? We know something about the chemicals. We don't know anything about. Is that what your point is? Yeah, I I think I agree with Holger. We need to take care of this and make sure we are consistent Consisting to not approach that try that one. I'm not sure which one it is that it's the next one Was one near the beginning? Yeah There it is. Yeah This is dbp But that had some wording that was now dbp was Probably better me Paul does that statement there a chap recommends that US agency responsible for dealing with in this case TX I be Modified that would that that be a statement that would End to address your concerns. I would say that not only other agencies, but also CPSC Including well, I think that in this case it would be including CPSC I say modifying it with that that would help But we could copy that Because the reason why it's because the fact we don't know Who is in this particular? We wouldn't know whether it's the dust from toys whatever It's the highest exposure. So CPSC has to be part of the equation In this instance, I was thinking of the other Statement the one down below One above that one Whoops, we lost you which one we talking about now Or the articles Let's go back to them. Did you did you cut and you're gonna paste it? Oh, I have you haven't pasted it yet Well, I did paste but not not the one. We're not the right one The chap recommends That here. Yeah Modify it appropriately Exposures would be primarily Concern would be I think I Probably just leave it at it exposures or even D at TXIB We have jurisdiction I'm not just that hasn't you have to conduct the research. I mean that's what we're missing here is research Conduct the necessary research That would support risk assessment report hazard assessment exposure assessment and then ultimately the risk assessment, okay? Because right now we're just living in the dark necessary research or research for it Hazard assessment and Exposure assessment Necessary for or it was for risk assessments to support risk management decisions We're that's awkward, but yeah, I know but we can always modify that I Don't like to with the view to support is fine You don't need with the view That's in essence what I'd like to see You know you can Or even a well it I think we use the word obtain because Not necessarily the government who? Okay, actually fine All right, that's strong enough Well, this this resume is gonna follow That we recommend an interim ban interim ban that would be our opening statement After we complete the risk we need to now Put in the the factors that Are our concern to us that lead to our recommendation? So let's start doing that First of all, there are exposures Hey in the real environment And that CPSC has found This comp this material in children's toys XIB however magnitude and extent of exposures with respect to Health outcomes is unknown and then Andreas. Maybe you can put in a statement or Chris on what you want to see done in toxicology Help us guide on exposure It's stronger not just that it's in the environment that that it's a prevalent indoor environment In the home environment That's a good idea and it's and was you know even I would Rate it. I mean 60% of homes. Are you kidding me? That's huge But that's up to a lot of things but there are a lot of things that are in 6% of the homes It's just a matter the problem we have is gonna know the intensity I mean, that's that's the issue where I get a little bit concerned because Prevalence doesn't mean a hazard, but the children are exposed Everything if it's in the dust children are gonna be high have higher exposure than the adults Yeah, well for everything. Could you say that's excellent. He is a frequent contaminant in the home environment Prevalent prevalent, but we don't know the intensity of it. Okay, that's fine, but a prevalent contaminant Say that children could be at greater risk. We don't know. I don't know what the risk is That's the issue in the dust. You don't mean you mean exposure at greater exposure. Yeah We know that because kids spend time on the floor much more of the time on the floor than adults That their exposures would be higher. That's about all we can say We can you can say that. Yeah, if you want to put that in considering the fact considering Fact that children spend much more time in close contact to dust deposit on the floor and Playing with toys Right their exposures Would be higher Or or likely higher. I mean it doesn't they would be higher It doesn't mean that if they're consequential, but they're higher It's a more exposure to dirt than adults. Why because they go in the backyard and they're playing the dirt But doesn't mean that it's toxic It's a matter of fact that the exposures are there It's a matter of the quantity of material and the duration and the All these other parameters would determine whether or not they may be toxic So do you want to change would be to is higher? Yeah, it's higher. Now the connection to the lack of toxicology that is really crucial. How do you say that? Well, but and then but this Eastman 2001 study where they observe some sort of aren't these anti-androgenic effects You don't know they could be but the Epidemons just take their sperm counts. Yeah, I just think a strong statement on the need for has Research on Identifying whether or not these anti-androgenic hazard is essential to to clarify whether or not these exposures are anything meaningful or In consequential, I think we should we could add that right? I think that's the key question here It and risks Up by hiring additional research It's also required Simultaneously or exposures to TXI be are associated with associated with anti-androgenicivity for effects that's I don't think you want to just limit it to anti-androgenic right Anti-androgenic and other health effects to it's necessary to determine or to assure safe use of the chemical Have it really broad? It's I agree. It's can't just focus on anti-androgenicity. I agree We go back to the famous Unintended conscious of consequences of MTB are associated with adverse issue Adverse health effects or or put Make that an or or a replace this year with anti-androgenic or Other other Health effects okay Before you say it the sentence of additional research is required wouldn't you want to make a statement about the lack of data Is the first two three line or two lines are about exposure? And then you need to basically say we have this is Concerned about the lack of factual that there's a lack of I mean, but that's a concern to us right in our making this decision Right, but we haven't we haven't used concern. Yeah terminology and the others just to keep it agree with with Russ We're not going to use concern. We're not going to use concern. No, it's chop. No, I know I know it's chop notes I don't see your notice. No, it's a lack of publicly available hazard information hazard information Or TXI be Therefore Very good add something though under the recommendations just I know we're supposed to be talking about risk and hazard and exposure And I agree with what Russ is saying, but could we add something under recommendations that the consideration of you know, some sort of a Communication with the company even at there may be an advantage to not having everything in the public In order to get the information that's needed because in this case there have been studies done, but We were unable to assess their quality without Further detail. I don't like that The point I'm trying to get to is I think I would like to say something about the process the process isn't working We're gonna say that in another section totally different but we repeat it time and time again under the recommendations here as well not just a recommendation for this chemical I understand that but That's that I think is is one of the biggest statements we can make and maybe that needs to be an executive summary I think I think that's where it's most I think it's more effective there Chris Because they're you know the people only read three pages will read that they're not gonna read over the other Part of the document Yes, everyone happy with the risk statement as it's written. Yeah, I just had a few clarifications so Hazard we say unknown minimal data do not demonstrate hazard. Is that correct? Because you know, we're basically saying That there's lack of data published data, we're only Viewing the summary basically do we want to say that the minimal data do not demonstrate a hazard or do we want to I? don't Because we recommend it I think Why are we recommending a minimum ban because the you know the the question we have at least about the Reproductive talks data is Right, but that hazard mine there was written months ago before our discussions today So I just want to make sure that We don't Miss that you know in terms of the minimal data do not demonstrate a hazard and then I'm at part B part B Yeah, I would not I would not based on our discussion. I would not think so, okay, so I would Buys that and then the other comment I had for my CPSC where you we say it's prevalent in the home environment And CPSC has found this in toys. Mm-hmm. Can you put a? Qualifier on that has has found this widely in toys has found this I Don't think we that's not known. I'm just asking Mike Oh, I think it's it's it's not a hard number, but I wouldn't go that way Went that way with the prevalent in the home environment. So the data Suggested that you tested well, we do we had a Some toys or and you know 15% of them had of the PVC toys Well a hundred and some toys and you know maybe 30 Something where PVC in 15% of those had TX I be so it's it's it's a The soft number work on part B Isn't that your point Russ that it's difficult to evaluate with minimal data what the hazard is but they're It just doesn't seem consistent with our discussion in the last half hour and then to say it's unknown But minimal data do not demonstrate a hazard and then we're going on to saying something much stronger in the risk and recommendations And even pointing out that the that the gestation window isn't appropriate for measuring antigenic effects and the study that's reported Limited data we have I would modify that just to say minimal data available. Yeah, that's it That's fine Leave it at that But the point I think to into to emphasize here is that these data Do not enable us to to make any conclusions about hazards that are indeterminate it's indeterminate Why I was concerned where we say do not demonstrate a hazard I mean we could modify it to say minimal data available that do not allow a Hazard determination could modify it that way as well It do not allow If we had thought about this a year ago When we had more time it seems to me that an Opportunity for the chap that perhaps we've missed is to be able to say there are some chemicals with data there are chemicals without data and Actually try to funnel towards chemicals that we know something about that are you know less hazardous than others instead of What do you mean by funnel? Well, so I mean we you know we can have ranked the Ballots that we've seen in terms of some of them are much worse than others If we're gonna use chemicals use the ones that we know something about that are less hazardous That of ones that we don't know anything about which is what we tend to Do you're asking for logic and unfortunately it doesn't always exist when we're dealing with these things We've we've seen instances where there have been unintended consequences as we use other chemicals and it's you know Cost a lot of money For all sides these chemicals that we're looking at now may very well be very good chemicals very safe But that's my point that we don't know it and that so there's no But that's my point also Chris because that's why I'm so reluctant about Banning something that I don't know anything about but the fact in absence of data Do I allow a kid to stick this thing in his mouth? There is the public health conundrum with Didn't desire not to ban all chemicals Okay, I'm going to move that we take a 15 minute break and come back Okay, so We'll be back at 1020 Hey to get a sense of From the manufacturer What other kinds of tox data that might be available and how much and it's something I'll Get back to with the chap in a in a week or so I don't know if it's you know because of where we are in the process I think We'd have to see how much information there is and so on but we'll we'll get back to the chap on that And will that be true for the other? five Substitutes well as far as I know this this only applies to the TXIB or the the isobuterate given what we we have here What what modifications? Chap like to make older do you want to? Modify the recommendation. I think in a way we have to more precise about the recommendations I Would propose would maybe like something like you want to begin with that or at the beginning Yeah, okay, I would start to say we begin with it. Yeah, I would say something like Chap No, I wouldn't would take out the recommend the chap does not own the use of TXIP in Children's ways and child care articles Because of the reasons stated above won't even have to we don't have to repeat it that Leads I think if you started the next sentence with a more over that would tie that into the next I want to say something in the hazard section about the fact that since this is not Thallate that Health or the hazard evaluation should be broader than just Antigenicity or do we do we say these criteria in somewhere else? It says Your or other adverse effects up in that I was thinking in the hazard part We could put up in hazard that that chap notes that TXIB is not A Thallate Pardon me and therefore It's tech its toxicity all they say that It's up its toxicity assessment is unclear. Yes, that's very good. Thank you Can I suggest that under those recommendations? I think well at the moment this is this is rough And I'm I really think we need to polish it more, but we can't do this now that we just indicate In in rough English what we're going to say it has to be polished later Did the choice of words with condone etc. It's probably not ideal Sounds a bit like a Magisterial or something I agree. I mean I think it captures the essence of what we want to say but You can use something like does not support the use. I mean something Different, but I don't know what does not support. I think it should say I propose I proposed that this recommendation expresses very clearly the situation that here Where we where chap sees the problem the situation is that There's a widely used chemical intimate use but untested and that's the problem. Yeah, so can you Where I mean right between more over Above and for more over the statement should be right. Yes, what exactly what you're saying This this is an abundant chemical intimate use pattern high exposure potentially But no toxicity data and no toxicity data is wrong but insufficient Adequate here available or just end it you confuse that sentence if you Said the chap does not whatever the use of TX IV and children's toys and child care articles because TX IV is an abundant chemical with intimate use patterns and potentially high exposure But inadequate toxicity data are available Then we should go on with therefore the chap strongly recommends that therefore I would even put in a strongly I have no difficulty with that strongly recommends Mike, okay So then the Recommendation for interim bound etc. I stand not made right. I think that's a reasonable Way to go in this Where did this leave it leave it in and say not applicable I think in some cases we just deleted it Do you want to add another sentence to the recommendation? Andreas Say not not this stage, but but it will need polishing, but that's editing and we shouldn't waste our time with that now If you know you can just copy that Saxon well To to a degree Think Mike D. E. H. A. Was a chemical you did not find in the well we didn't see it I think we saw it in the past. That's why it was on the list. We didn't see it this time One of the things we did notice in the food studies is that there is Exposure from food. I mean the micrograms per day are higher than the phthalates. I Don't know what that means, but you know, there is exposure from food Because I think it is approved for use in food packaging The focus of these reports has been based on reproductive and developmental can't Summaries in the adverse effects section about other endpoints available Well, let's see. I know we that we the staff did do Touch review we have touch review views available for all of these that cover the spectrum of effects But I think what the chap has written so far covers reproduction and development That's largely because we've been focusing on phthalates so for the right for the case of substitute chemicals that are not phthalates Would it be reasonable to have a more? General Fox evaluation in these sections. I don't want to ask for it, you know a mountain But do we want to talk about more general guidelines criteria for these substitute chemicals that aren't phthalates instead of spending our time now on Evaluating single chemicals Yes, especially if we're gonna if we agree and I'm not sure We all agree, but if we agree to ask for additional information on the talk studies Then I review it should consider those I Think we need I think it's a better use of our time right now Then things can be put together and Make some decisions Later the logic is and you guys know more about this whole group than I do but when it's a phthalate we have certain Focus because it's a phthalate and we know something about phthalates if it's not a phthalate Just focus on the antiandrogenic effects is not it's not adequate Criteria do we know do we need to go back to other chemicals that aren't phthalates in what we've already done besides these Substitutions other chemicals that aren't but now that we've we've come to an agreement Well, we here's a consensus in the panel that we're very uncomfortable with these data gaps and having to make recommendations in these situations when essentially the risks are indeterminate So since we're not tying this now with any recommendation in terms of interim ban or whatever Why why what precisely are we needing criteria for now? We can note these concerns every time that's appropriate and that's it Think about it. It makes sense. So you're saying the recommendation throughout would just be we don't have any data We can't make a recommendation. Well, let's just see what we get requesting more data. Well, I Think well, this is yeah, yeah, we have data just as an example DEHA is probably one of the more data rich ones and there are data. This is just part of a table on repeat dose studies, so Some of these do have data Looks like I know this DEHA there's been two-year studies, so They're they're older studies, but they have most of them, but they have been done. So Many of these are Looks like many of these are so And we have the reviews are done we could in a short time summarize the non Reproductive developmental data in the same format that we have I mean that could be done in not probably not by noon, but but in the early next week And we do have some data on the legibility of these non Valid substitutes from toys Some studies been done by CPSC. So at least we have something to work with again, it's not totally sufficient, but at least it's something to Start the discussion Yeah, and here's here's one where the DEHA There is at least one developmental talk study of sufficient rigor That at least the doses that they used the highest dose there was no antiandrogenic effect noted and it was done at the appropriate gestational stages now this This is a Summary of what we have TXIB So I mean there's information, but I you know, we don't have the underlying studies. They got repeat dose studies Up to 90 days. I at least Reproductive and developmental studies See some of the end points where they're noted All right, well if you can get these summarized for us then we can work on it, but Andreas, I think we'll go back to his point, you know, do we need criteria doing Feel that it's comfortable going the way we're going with these other chemicals As we did in the past or do we need to do something else? Well, I think I think we were in agreement that As with TXIB we're gonna look at in production Whether they were in toys and personal care items Criteria we developed there and and others if necessary and We can certainly Put those together for the other phthalates substitutes and and Send them around to the chap and We can develop I think recommendations Excuse me. I think the criteria would be the same. Yeah apart from the fact that these are not phthalates, so we would need to Just focus on anti-antigenic right, but I think the criteria in terms of exposure and risk and or exposure hazard risk That's where we'll carry forward I'm okay so and and I guess also if If there's information about exposure in terms of children if there's migration information if there's right all of that So yeah, we have that for several of them and that's going to be in in Paul's Section of the report to That's done. Yep. It's already done The question is is that The question I had before is that it's really insufficient and that's why I was troubled on it before I even walked in the room this morning So at least now we will have some data and we'll be able to at least I Think make some reasonable judgments on the level of science we have available to us No question next steps and timeline and well the the timeline so you're taking something out of your pocket Yeah, and I will I will send this around by email, but all the writing assignments that we agreed to and For example, I will I will redo the DNOP and the DIDP We will complete the recommendations for the phthalate substitutes we will Mike has done the recommendations for all the phthalates all these things will be communicated to the chap will be due By the 17th of March Okay And the recommendations for the other alternatives. How are we going to we're gonna do that by phone call or Email, I think by email. Yeah, so I'll send those around as soon as I can get those together and then Hopefully we'll have a final I think it might be helpful to have a Phone call though If it's possible to schedule it just because I think there is value in having a Discussion you want that done after we develop Something to look at yeah, okay, we'll do that that would be that would be only way otherwise It would be Not the most productive use of it. Yep. Okay, so it might be that we get the data and we can do it on our own With emails and we decided to cancel, but I think it'd be good. So would that be like in early March? phone call Problem is you're bumping into sRT at that point and Phil just to confirm what we said yesterday The structure of each of these is going to be different. You're not gonna have a bullet For every talk study and every human study. It's gonna be a summary. Yes, and okay, and I'll do the human. Yeah Oh, and that's another point Holger you were going to provide me with summaries of exposure Okay, and I don't know Paul We were gonna provide me with what were they the phthalate recommendations Where there's information about? Exposure that was relevant to your Information Yeah, we discussed yesterday. I'll make sure that's complete in each one of the recommendations Yeah, you're gonna send me anything you want there are two things that I did provide Mike one was the connecting paragraph Where that that table with the non? Table of a computer comparison table and we'll just have to review it and then there was a table That was that the three or four paragraphs I sent now both morning and I sent you an update on this entire issue of data Sources gaps and what's needed to go to make this a better process Of that And before before we conclude Sherry fall via our general counsel wants to come down and talk a little bit to the chap So I got ten minutes, so I think we can do that now hey Okay, she's on her way down Does we have to catch it? Unplugs that I don't interrupt her When is SLT? Second week in March Conference call before that Well, we're gonna have the it's gonna be based the conference calls gonna be about the phthalate substitute recommendations, okay, and Those we can have ready By the end of the month. Yeah, we'll send those around and that I mean you do you want to set a date for that? Week of the fifth with that work. I have a medical issue to deal with that week So I'm not sure so week the week of March 5th Well, you may have times they can't meet About March 2nd and Paul before Friday March 2nd. I'm in I'm away that day. I'm in meet me to about March 1st you see you on holiday as well. Oh, let's let's just Michael send out an email and we'll get your calendars and set up a time that way. What about Friday the 16th? March March 16. Yes, so that'd be just after sRT. Okay. I can do the 16th You can't do the 16th About the next week now. We're getting too late then may be able to do the end of the week of the 8th the 5th the first week Before that's OT, but I'm not sure yet. I have to finalize a couple things How does the the week of the 5th look for other people? I Could do the 6th or 7th Chris 6 is okay Wednesday I've got class at one o'clock Tuesday the 6th. I can't I'd it be I'd only have like an 11 to 12 o'clock window on the 6th the 7th. I'd have more time in the morning Just because I have a student committee meeting and then a seminar on the 6th But I have 11 to 12 on the 6th and then Pretty much any time till about 2 on the 7th, but Paul you're you're out for that. I'm not sure yet All you were saying maybe the 8th or 9th in the morning the end of the week may be better for Paul No, not for a huger. Okay Yeah, I think we'll we'll do this by email Mike Um Whenever you're ready The role of the Commission in policy and the chap on science and I Haven't been listening to this morning session, but Those in my office who have thought it might be helpful for me to come down and talk to you about I Know it's challenging when the science is not Complete and you want more science who always want more science, but we need Scientific recommendations. That's why I took the time to write out That with regard to the substitutes with regard to these other phthalates It's really the Commission's decision whether to to ban them We don't really have interim ban authority Congress can do that, but We have a regulatory structure that's pretty straightforward and is driven by science and The Commission's looking for that science from you now if the science isn't there and there's need for additional study There's no reason you couldn't recommend with regard to a particular group of phthalates or phthalate in particular We really just can't give you a recommendation on that. We recommend that you Continue to study it vigorously in and in a timely manner, but you can't really just I Mean you can say whatever you feel from a policy basis I'm not going to tell you can't express your views of course you can but What we're really looking for is science and so I just wanted you know if you have any specific questions I know two people have to leave we can also continue this dialogue that you could send written questions I can respond written in a written manner or We could I can participate on your next conference okay anything you'd like, but but while you're here now We just drafted a few lines. I mean is it worth Mike just Showing her what we wrote if that's sure everything the realm in charge of because we wrote it You're here might as well. Okay show you if others I don't usually like give legal advice in public but just just to see it based upon what you've said I think that's where we are you can take more time if you don't want to respond okay, but based upon what you just said I think we're in the same place good. Okay, we struggled but we're in the same place Recommendation is and it's short so short to the point Yeah Available Right, that's exactly where I am Okay, I also know there was some discussion about confidential data It's really hard for us to do a rulemaking With not without being completely open about science and I know you're relying on someone I think it's Shauna Swan. Is that right? Some data that maybe is going to be made public eventually as part of this and so, you know We would be if we were relying on that and didn't make that public we'd be criticized and You know anything we rely on we need to give the people who want to comment to us on the science the ability to see what you relied on and Respond to that and so that's my concern about that and I just wanted to make sure you all understood that We can continue to wrestle with that issue But isn't that basically because of the Shelby Act the Shelby Act basically said anything used for regulations has to be able to be reviewed by all parties Variety differently, but that's the most recent. I think regulation or Congressional law that came out. Well, we're aware of that and we we we've made we've made an effort of basing our recommendations on data published in the period literature and I don't think Shauna Swan's name was not mentioned at all in that connection That's published You know, maybe the individual values for each Child of pregnant women or not, but the the data is published in more of a summary measure And I think everything else too that we've Considered Thank you. Thank you. Bye. Thanks Russ So are we adjourned? They're adjourned. Okay. We're adjourned. Thank you