 OK, Chris. Have your revised section up on the screen. Is this on? Introduction was largely edited by Andreas. I think focused more on dose addition, independent action as concepts. Is that right, Andreas? That's right, that concept, yeah. And the third paragraph, a little below that. Help if I highlight it. So I guess the point is that there's evidence of dose addition using animal studies. And then the discussion of the concept of dose addition. And to incorporate that into a cumulative risk assessment, we chose to use the hazard index. And below that paragraph that's there at the bottom of that page, Andreas wrote a paragraph describing kind of alternatives. Do you want to jump in, Andreas, about that? Sort of why we chose their equations there that haven't popped up for some reason. So where this gap is, Chris has. Oh, I know because it's in. There were the formula. There we are. So now we now understand what the hazard index approach is. Oh, yes. And if you now scroll down, the HI offers flexibility. That's a paragraph I included because having said earlier that there are other risk assessment approaches based on dose addition, we felt that we need to say why we focused on the hazard index approach and not on any of the others. And that's basically what this paragraph says. So did I go on? Or you guys want to read more about that? So it is true that the point of the paragraph is saying that you can use different uncertainty values. It is true in the case one, coming from the Court and Camp and Faust paper, we use different uncertainty factors as described by them for various reasons. But in the other two cases, we chose an uncertainty factor of 100. But I think the point is still a good one that we have the one case that has the differing quality evaluations of the studies. The next paragraph is the beginning of the three different sources for the RFDs. A little bit more enhanced of what was there before introducing the three different cases. The explanation at the end of the last sentence, we consider multiple cases to determine the sensitivity of the results to the assumptions for RFDs and the total impact on the hazard index approach. Like it's introducing the next one, but actually is referring to the thing it just completed. I mean, we can change that. It's like that later on. This was just. Yeah, but I know structurally here it doesn't make it. Right. And then case two, I started looking at case one. I said, no, this is case two by simple logic. So wait a minute. Let me repeat that for everyone. I think that the case one at the end or case two at the end or case three at the end of the discussion should be removed to the front of the discussion to make it clear for anyone reading it that case one refers to we, et cetera, et cetera, et cetera. OK, how do we do this, Mike? Do you want me to make the edits and send it to you, or what do you want to do? Yeah, what exactly? Where it starts there with these. Second sentence. Case one. Just put case one includes published values. Case two includes values derived from recently. And then he says, case one, three lines down. Get rid of that. Things are not working. Right, right there. It would be on case three. From the de novo. OK, OK. And the next two paragraphs are trying to focus more on biomonitoring, measurements of actual mixtures of exposures, and then they're going to be incorporated into this hazard index. So to estimate daily intake's paragraph, why does that look so different? I'm having a hard time seeing. We actually have a paragraph break. Well, the breaks got lost for some reason, but to estimate. And then the chat below that five or six lines down is another break, I think just for emphasis. OK, so to estimate, paragraph is trying to say about biomonitoring data offers measures of mixtures of values per person. Can I suggest this paragraph where you just are where the cursor is clicking? Chap has used a novel by calculating it for each individual, not per individual. That's a good point. Other few words to the right. Go on. Yeah, by calculating it and now delete the pair instead for each. And then same in the parentheses, too. Do you want to change that in our case for each pregnant woman and infant? That's largely for emphasis. This is in contrast to the standard hazard index method of using population percentiles from exposure studies on a per chemical basis. Yes. And then there's a paragraph break, then, we applied data. That should be a break that reapplied should be just above where the cursor is. That should be the paragraph break there. OK, so that's largely just setting up. I hope that was in response to what you guys were saying earlier. Yeah, perfect. Then, sorry I didn't put it in. But then we emphasized it a little bit more. If you scroll down a little bit more, where the cases are specifically described, it's funny that the page, there's a lot of breaks there. Everybody's section was a little bit different. OK. So this was meant to expand a little bit what was there, a motivating sentence beginning each case description and then the details. And then I believe the only other change was in the conclusion section, which we didn't paragraph. But trying to point out that things were similar across the different cases repeatedly. Paragraph there, yes. We're open for suggestions if you want to make that stronger somehow. It's largely just a description of what we found. It's not a conclusion about what it means. So I think that should be later in the report. This is just based on the numbers. Yes, that's a good idea. And then the only other change I think that we made is in Table 2 there, pages down. So this is, if you look on the second column, the range of the points of departures. So this is using the three different cases. And so we changed it before. It was a parenthesis number comma second number parenthesis. This we thought maybe the dash made it look more like a range the second column. So those were the changes. Table has generally. Is that based upon this? I'm sorry, what's your question? This is based on the median intake. From the biomonitoring data. Yeah, all right. But that summary table that we have, did you extract some of the information from here? The summary, the table I have with the, yeah. It's, I think it's based on the same information. I mean, it's the information Chris sent for Serge's report. Right, the comparisons. Yeah, yeah, well, Chris gave us median and upper bound exposures for each valley. Right. And what I want to look at here, consistency. Well, these are points of departure. I mean, excuse me, these are. The second column is the real column. Oh, yeah, yeah. That's the real one, right? Yeah. Now, which is that? What, NHANES? NHANES. If I look at NHANES and I look at adult female for DEP, all right, average is 5.34, right in that there? Do DEP here. This was just for the six that were included in this analysis. All right, give me DHP and NHANES, 3.62. So this is, is that truncated or? Yeah, I mean, these numbers, there's no point in putting a lot of significant digits. Yeah, but I don't, I'm not looking at consistency. I'm looking for consistency in the report. That's all. I understand what you're doing, but I want to make sure that A and B have coherence. Right now, I have 3.62 and you have three. That doesn't work. I have three significant digits. You have one. And for DI, D-I-N-P, what do you have? And I got 0.92. 0.92, 0.92. Are we looking at apples and apples or apples and maybe? Now, what are you giving us, medians? I'm giving you average. It's the median. The average, this is, the average here is the median. In my table, I put the average is the median, yeah. All right, well, let's make that clear. But there's still a difference. The numbers don't match up totally. They match up. They're within the margin of error, but they're not, they should be exactly the same in this case. There should be no ambiguity. So where's DI, B, yeah. 0.2, getting close, 0.18. We're closing in. D, B, P. 0.6. 0.61, now that's close. D, P. All right, so we have some within a percent and we have some within 50%. Hold on a second, look at B, B, P. We don't have that here. I have DNOP. No, wait, wait, wait, wait, wait, wait. No, I, how about DI, D, P? 1.26, we're a little bit off, so they have to be checked, they have to be checked, all right, for adult women, right? This is adult women, we're okay. So, see part of the problem is in the middle of all of this, we switched from unweighted to weighted. And I'm not quite sure if this is a table of the weighted or the unweighted. I mean, that could explain different numbers. I agree it needs to be consistent, but all right, well, we have to check it. All right, if it's weighted versus unweighted, we just have to say that. The differences are not going to make it, they are not going to substantially change any conclusions, but we do want to be able to be sure that we have something that people when they look at table A and table P don't scratch their heads, right? We just don't want that issue to arise. Because in the end, they're essentially the same. I see another thing, what I put in my table was the NHANES women, and this table is the pregnant women, so that's why they're small, that's where the disagreement is. Oh, okay, well, then we just have to say that. Yeah, yeah, yeah. These are issues. Well, this table is pregnant women, my table is all women is all women, and you know, it was. All right, well, as long as we're able to explain it and do it clearly. So it's Mike's fault. Yeah, it is, it's his fault, it can't be Chris's fault. It's not her fault. Oh no, it's not Chris's fault, it's because I did it. It's your fault. Last night, people. You didn't do it last night. Just before I went home. You were rushing out for Valentine's Day, so therefore, you're allowed to have an excuse. But Mike, we need to, that's not in that table legend, so. No, I'm sorry, we have to get these things clearly identified. It needs to be specified. I think that's the whole issue here. Type in here that, well. In this one, we just have all women, but the other one we have to put down, pregnant women. I suppose you're asking that. Or pregnant women, or pregnant women. Paul. Yes, sir. This is data based from my chapter. I will double check that. Okay. I will double check it in the tables I have, and I will double check that. I'm not concerned, I'm not concerned, but I just want to make sure that we have all our eyes dotted and teeth crossed. But I do think in this table, it would be not a good thing to have too many digits there. I think they need to agree for rounding. Yeah. But I don't think we need to put four digits on that biomonitoring. Yeah, I also had a problem. The only problem which I really was going to bring in offline in the comparisons table was that there's no way we can have four significant, 34.23, give me a break. All right, where are you? I'm back at the comparison table. Oh. We have numbers that go out like 1114, and we have ones that come out 43.02. So, but in this, in this case, though. Well, you know. Are you guys? Then who? He's looking at something. We're not looking at the top. I'm looking at the old hand, looking at the comparison table. I got copies to hand out. All right. It was just a, in haste. Don't, don't, don't have to, yeah. So in this case, though. Don't beat yourself up. Does it bother you to have the margin of exposure values with that many digits? It does me, but I don't know how else to represent it. Well, I think they're a little bit too many. I think there's way too many, but when we tried to round them before people complained about that. So I'm not quite sure where you guys sit on it. I don't really like having that many. I usually like three or less, depending upon how much. So look at the range values. When you say three or less, you would want to change it to three digits and then zeros? Yeah. And what you would do is three digits and then go 10 to the X. But, but you have to keep perspective on being, on avoiding to be over accurate. Three digits is, is a little crazy, I think. But if you have three digits times 10. On the margin of exposures. So should that be 32.8, or if we put, 32,000, 33,000? If we turn 166 times 10 to the two, and then, you know, we did it by putting the zeros into a, some kind of less obvious format. So a margin of exposure in hundreds and thousands? Yes, in thousands, or in hundreds of thousands. Like 25 to 625, eight to 83. Is that what you're saying? Yeah. It makes things a little bit less cumbersome to explain. Not providing the relative results of an election here. We're briefing a relative range of information. There was just pushback when I rounded before. I don't know, I didn't know where the, what the committee thought of that. Okay. Did we round it to thousands? Yeah, thousands I think is perfectly logical. In that way, we protect ourselves from criticism, but at the same time, we are providing information that's meaningful. Okay, so Mike, do you want me to, how do we want to do that? Do you want me to go ahead and create the table? Well, I can do that offline. Okay, okay. But again, let's look at this. What we're doing here is we're basically number smithing. It's not changing our overall values, the overall conclusions or overall level of certainty or uncertainty. It's just trying to come up with a way of presenting this stuff so it's consistent and allows the reader to understand the thought processes. Maybe put it another way, Chris. We have so many uncertainties. Therefore, we have a certain level of certainty. And to us, I think the level of thousands is reasonable. Going beyond that in terms of digits doesn't make any common sense. Or even 10,000. Well, yeah, but I'm saying is at least it gives us a boundary from which to operate. We're boundary within which we can operate. And what we haven't said here, and maybe we should add something, I don't think it's here, is what we think an extreme value of a margin of exposure is. Is a thousand, the value that we would be, if it's in? Yeah, what you do is you put it up in thousands and just leave the number 25, 80. Okay, okay, yeah. Put the word margin of bio intake in thousands. Why? It's the same thing, in thousands. Just saying the units are in thousands instead of. Yeah. Okay, for you. My feeling is that we are more used to. With all those zeros it drives you a little nuts. Well, if it's zeros, it's zeros. But it's not zeros, it's in the levels of uncertainty. That's why thousands gives us a degree of comfort with what we think the data means. If we start putting more, if we start putting other, we start putting all the zeros out in there, we're not sure what that means, why are we doing it? Can we not say round it to the next thousand? Isn't that what we're saying? Yeah, but say it like that in the table, up there. I think you and I are saying the same thing. Well, we can put it further. Yeah, of course we are, always. Just, here's the English bent in minds, you're Americanized, Northeastern Americanized. Let's have a look how it looks like. I'm not sure what your concern is, Holger. That's all, because we have levels of uncertainty and we have to at least acknowledge that. It's not the level of uncertainty, it's putting in factors. If the hazard index, and now we have margin of safety, which is not thousand, but one thousand, I would prefer to see the real numbers. And with margins of exposure, I am used to looking at the real numbers and not one K, two K, three K. Well, okay, the other, the in-between option then would be to leave the numbers the way they are and put a footnote and say these are based on calculated values, we don't, you know, interpretation of all the numbers is not implied or something. Then you open yourself up to more and more and more explanation. I just don't think it's worth it. Honestly, brothers and sisters, why are we discussing this right now? This is a really trivial issue. That's why I think just make it thousands and leave it at that, period. How do you want to have the numbers written there? How do you want to have them there? Just in thousands? Yeah, okay. But you leave it there as 10,000, 5,000, okay. Whatever floats your boat right now, because I think Andreas is right, let's move on. Okay. So we're, we don't know what we're doing right now. Right now, they're arranging to have Serge call in. Well, we can do that too. If we do, we have any deck chairs. Okay, Serge is gonna call in. Great, yeah. Well, what are the critical issues that we have about his report? What, you seem to have a bit of angst, Holger. I just wanted to make sure that all the basic data is checked and double checked, that we are not missing the digit and that we are not in the wrong ballpark, but I'm confident that both you and Mike have gone through the data. And not only us as staff. Yeah. I mean, I see Kent. Kent and Leslie have done a lot. Yeah. And... Have they checked our stuff too? I mean the biomonitoring stuff. I know they've looked at everything. I don't know how much effort they put into that. My concern is when things like this come up, discrepancies, there have been so many versions of this and that and we've changed this and that. You know, I've done my very best to try to make sure that we're looking at the most recent version, but when we're pulling things from old tables and things, it's... Yeah, I mean, it's a challenge, but we'll just keep aware of these things like that table, this table. I mean, it's... I guess once it's in the report, we can always go back and try to verify it and... So we'll go through that stuff. Yeah. Yeah, it's hard to look at the numbers. Oh, that's the right number. I can't do that anymore. Well, the key problem we were having for... The key problem we were having before, Chris, was the fact that there were so many numbers in the Versa report. We had to sit down and go over it where we thought there were issues and also the data uncertainties because I told you some of the data was really, really old and we didn't think it'd be appropriate. And that's why we changed... That's why some of the... We didn't change the numbers. That's why the calculations were done for newer data sets. So in the comparison... That's the newer data sets. You have the Versa data set and then we have a CPSC data set. So the CPSC data set is the one you adapted in the last round. Yes, yes. So this is the... It's new. The corrected or modified Versa report. Modified Versa. And that came out of the last meeting when Paul was up here. Waiting for Serge, I guess. Have we finished? Yeah. Your section, Chris. Yeah, I think we finished. Okay. Yes. Then we want to move on to your section, Paul. I don't think he's put in the changes yet. You haven't put in the changes yet, have you? No, no, unfortunately. So we might have to wait for that tomorrow. Talking about the Versa data and where we are. Waiting for Serge. Yeah, well, he'll be... I just sent him the number he should call in in a minute or two. I mean, it's a big report. Took a while to wait through it. Well, Holger, how much time do you think you need to go over all that data? I would think it's a couple of days, just not to read it, but also to digest it and to have the feeling that safe with the data that has been presented here and that it has just been presented a couple of, let's say, days ago to us. I want to make sure that the data settles. As Paul said, it's an enormous data set. It is, and also, as we're trying to do the new work, at the same time, it's going back over there. And as you can see, looking at the original Versa report and the modifications, there can be some differences that arise. There are, yeah. In terms of the bottom line, the conclusions, Paul, that you reach in your section, Holger, spending two days looking at the data. Not going to change. Not going to change. Again, remember, all these numbers are based upon the fact that that's the available data set we have. And so, therefore, there are uncertainties and those uncertainties we carry through everything. And if anyone wants to make a beef about it, we'll then give us some more data and we'll be happy to improve it. It's a daily hungry process and it can be easily, easily fixed with better exposure data. Real data. If the factors themselves, they won't change. Exposure factors are more meaningful. The best we have, the best EPA can offer. But still, it's, I think, this time now or the first time that we discuss all the, let's say, interpretations of the final data. The first time that we discuss the contribution of the different routes of exposure, the significance for our approach, and so on. So I think I need some time to digest the information we are or have been presented. Absolutely. I mean, there's so much, you know, it's hard to keep up with it. We're going to go through it today, at least on the top level. Well, yeah, we're expecting Serge to call in in a couple of minutes. Hi. Hi, this is Serge. Can you all hear me? Oh, yes. Hi. Hi. Thank you for joining us. He's got the question. Okay. Were there any general questions before you go through the data? I would like an overview. If somebody could just present the overview of what's here, because, like we say, there's so much, but can we just start with... Okay. Serge. Could you give her an overview of what's in the report? Um... Let's give Chris an overview. This tab eight? Okay. Let me pull up the document at my end. Please just give me a few minutes. Sure. Yes. It's tab eight. Chris. You can tell it's the big one. Yeah. It's the big one. And how it's modified from the last version, Serge? Yes. You had an initial draft, and now we have a new improved draft. Okay. Okay. I'm just opening it up at my end. I should be up shortly. There were a few things that we modified in this round when compared to the draft report, and I can, you know, kind of go through that quickly. We made some changes to some of the exposure equations, specifically the Mauding equations as it relates to infants and toddlers. There were some inconsistencies in the concentrations, and we redid the calculations for that, and that affected, you know, the charts and the pie charts and the tables and the graphs. And we also provided some additional information in the write-up of some of our assumptions as it relates to how, you know, the datas were compiled mainly for salate concentrations. And these had to do mainly with some of the assumptions that we used to calculate the means in the 90-50 percentiles. And the last thing that we did was we created a table which compared the aggregate daily exposures for the eight salates with some of the other direct and indirect methods, the indirect methods, of course, being Wormats and Clark. These are some of the main changes, and I can go through the general format of the report. Should I do that right now? Why don't you start with what the executive summary deals with? Okay. Then go backwards in there. I think that's where Chris is heading, right? You want to know what it means, Chris? Sure. Start with the executive summary. Okay. Summarize the executive summary. Okay. In general, what we did was we calculated the daily exposures for each of the eight salates across various products and exposure outs. And having done that, what we decided to do was we decided to reclassify these daily aggregated exposures based on specific product categories. These categories were suggested by CPSC. Some of them fell under the CPSC jurisdictions and others did not. So we wanted to create a table which kind of showed which ones fell under the categories and which did not. And we wanted to provide percentage estimates, that is, which product has, you know, contributes what percentage of the daily salate exposure to a particular subpopulation. And remember, we were dealing with four main subpopulations that included pregnant women and women of childbearing age. Infants, which included zero to one years, toddlers, one to three years, and children, three to 12 years. And what, in general, what we found were food and beverages and drugs. These two categories contributed most of the exposures for almost all the eight salates that we looked at. And, you know, within each salate, there were some, you know, other products and categories like children's toys, cosmetics. And so the executive summary, you know, gives a brief overview of, you know, the overall methodology that how, you know, what steps were taken to come up with these final tables or results. And then it looks at each subpopulation and kind of gives like a short summary of, you know, what the overall exposures were and, you know, from which product categories they came from. I think that's, you know, the main gist of the executive summary. And again, just a little bit about the process that we went through to come up with these numbers. The first thing, of course, was to compile salate concentration. So we looked at a variety of data sources. The main objective was to look for data that belonged to the U.S. and that was published or researched in the last 10 years. That was the first step. We created a database of these salate concentrations. The second step was to look at, you know, some human behavioral patterns, which mainly relates to how humans react or behave in a variety of media or how they interact with some of these products, to which, you know, they could be exposed to salates. And then these factors were then combined with the concentrations in specific equations to come up with estimates of daily exposures. Now, the exposures that we calculated, there were two metrics that we used. Since we had a variety of concentrations, we decided to use, for simplicity purposes, the average concentrations and the 95th percentile concentrations. So what that means is I'll give a very small example. For example, let's say we looked at salate concentrations for DEP in cosmetics. And we were trying to look at how women could be exposed to this through inhalation. So we looked at specific studies which had values of DEP concentrations. So we obtained, say, 20 concentrations for different studies. And they all were concentrations of DEP in a variety of cosmetic products. So what we decided to do then is for each product type, we decided to take the average DEP concentration among the list of, you know, values that we found and also the 95th percentile of those values. And then these two metrics were then used in combination with the exposure factors to come up with the mean exposure and the 95th percentile exposure. This was done across all exposure routes, all product categories, and all of the eight pallets. And then these results were then aggregated to come up with these daily aggregate tables that I talked about in the beginning. That's all that I have for the executive summary. I just asked a question about style. So I see you've got pages and pages of references, but they don't seem to be referenced in the document. Well, the reason for that is these references were all studies, articles that we looked at, mostly to compile the pallet concentrations, but also some exposure factors. So some of these values you will find in the tables for the exposure factors. The rest of it, I believe the majority of it can be found in the tables that have the concentrations. Now, the tables that have the concentrations are currently in an Excel workbook. They were not provided in the report, but the mean and the 95th percentile concentrations, which were the values that were actually used to come up with the exposure, have been provided in the report. So a more basic question there, like I'm reading the second paragraph of the executive summary, refers to the indirect method of assessing pallet exposure to humans. I mean, not being in this field, are there references that could be added there for largely to give the impression that this is not a new, these aren't new approaches, that these are approach that you're following sort of, you know, high quality but standard methods. Yes. Marty, not in the field. That would help me just to give me an anchor. Sure. There are plenty of those references. Correct. There are plenty of references for that. Do you have them surged? Do you need to be directed to them? No, no, no, I can put those in. I think there are three or four, they're mine. And then also in table nine on pages 21 and 22, it refers to equation numbers, but I don't see where the equations are. I was very curious to see the equations and I couldn't find them. The equations should be in appendix A, which starts from page 36 and go on all the way to 37. Oh, there it is. Okay, thank you. You think we need to put something in there to give you direction? That would have helped me, but... Serge, can you modify that to give her a clear indication that these equations should be found in appendix A? Okay, and you were referring to which table? Well, in section nine, table one, on page 21, the last column refers to equation numbers. Okay, so just say something like provided in appendix. Yes, that would be helpful. Serge, everything you can make clear makes things easier. Okay. Just to be... I'm sorry, I'm maybe thick about this, but so it looks like in appendix A you've got inhalation exposure, direct and indirect, the oral, different kinds of exposures. Is there an equation for how you got to the cumulative? No, no. And all we did was just an arithmetic, we just added those values up. But, you know, if that's something that you feel that we need to specify, we can definitely write that up, that be a little more specific about how we came up with the aggregate values. I think that would be worthwhile. We've been doing that with everything else today. Okay. So, therefore, doing it for what you've done is consistent with everything we're doing to make the report clearer. And is that a standard way of doing it, just to add across the different exposure routes? Well, as long as you have it in the units they have it, which are milligrams per kilogram per day, and it's the right biological response that we're looking at, and they're all the same. Yes. If you do it willy-nilly, no. You know, like let's say you're looking at inhalation versus dermal versus ingestion, and you're looking at, you know, effects that only occur associated with one of those pathways when adding it up is kind of ridiculous. You just focus on the one. So, it's all contingent upon what you're doing with the data. Am I correct to say by adding it up like that, what's a low value in one is going to stay like adding lows and lows and highs and highs? Yeah. Mm-hmm. Yes. But it's also because of the fact there's a consistency in what we think of the, you know, the health outcome is and based upon the impact. I mean, there's no other way to do it. No. Unless you wanted to do a, you know, Monte Carlo type analysis, but with this big of... But the data is so, so... Largely, from my perspective, looking at it from not being in the area, as long as it's sort of the standard, the state of the art for doing it, I think that's fine. It just needs to be specified like that, I think. But then the big numbers that we're getting from this, I think based on the discussion we had this morning, is going to be what's the percentage of exposure, you know, what... For example, DEHP, it says, where did I read that? 84% of the exposure. It's diet. So those percentages come from taking the total and then going back not to types of exposure, but then looking at it by ordering it by chemical, right? So that's a direct calculation from that distribution of the sum. I mean, there's two ways of slicing it, by chemical and by source. Is it worth putting that... I think we have... ...specified? We put that in the summary report. We put that in the small short report. We stated that's how we did it. We sliced by both directions. Do you have that in your executive summary? I think that's the critical issue that Chris is bringing up. The fact that these things are sliced in many different ways. You're sighing, so that means you don't. I'm trying to be honest with you. I'm trying to think if that was something that, you know, we had included. It's here. It's on the third paragraph. Sorry, I'm just... Sorry, Serge. You did the right thing. Paul. I'm still having some problems understanding the data because we are hoping from absolute numbers to relative numbers. We are hoping from the daily intakes from the aggregate exposure in micrograms per kilogram per day to saying later that 80 or 90% is from the diet. So let me give you an example now. Let's look at the data for toddlers, for example. DHP, Inversa report. The aggregate exposure is 2,133. Can you give us a page, Emma? That's table six, page 25 of the report. That's here. The lowest line. HP, 2,133. I assume that this is the median aggregate exposure. Correct. If I now assume that only 1% comes from toys and childcare products, assuming that 99% is from the diet, this would still mean that we have 20 micrograms per kilogram body weight per day, which would still be above the tolerable intake for the reference dose. So this is the problem I have looking at the absolute numbers in relation to the relative percentages of the daily intake via the diet and the sources we have to focus on. Why is that a problem? Because if it's still above the daily intake, then that's still a problem even though it's a small percentage. That means the issue is that this stalate is really out there at levels in all roots of exposure that may be of significance to the health and welfare of a pregnant woman or child. In other cases, it may not be. So what I mean, it is interesting to know the quantification of the roots. But as we pointed out this morning, we maybe need some information on the loasness to the reference dose of the daily intakes we calculate for the routes of relevance for us here, for the toys and childcare products. Doesn't it do that? It's not that clear in other tables here. I thought it was clear there. Because it's like in table two. It only says the percentage. I thought it was clear in the short report. Yeah, but you have to jump between the tables. I don't know how you're going to not jump between the tables. There are just a lot of data points. Remember, we're doing cross-sectional analysis among two different... We basically have a three-dimensional plot and we're trying to understand this is sources, this is phthalates, and this is the exposure. If you have a look at table two, for example, if you scroll down. Here you see the hard numbers. You know that for DHP we have 2,133 micrograms per day average daily intake. Now we look at the percentage table and look at DHP. We see that 74% is diet and 24% is apryl. So that's for the pregnant women if it's called down to the toddlers. For infants and toddlers? Toddlers here, DHP. So it's now not that clear anymore because... Why? Is the drugs in that case? It's drugs. You know, DEP. It's still diet. Now it's toys. It's only 0.2%. Where's the toys? Toys, 0.2%. For the toddlers. Where are we now? It's infants. We're infants. You want toddlers? Okay, toddlers. So it's 0.2%. Right. But giving the 0.2%, we have to know the absolute number which is in terms of the daily intake. Exactly. In order to say, 0.2% might be a critical value. Although it doesn't look critical. 97% comes from diet. It's not a critical value. It's still within a noise. Yeah, but what I try to say, if it's only 1% or 2%, the estimated intake from the aggregate exposure approach would still be above the tolerable daily intake. Even if from the aggregate exposure approach, the majority is still from diet. Yeah, I said that before. What? I think that we need to find another way to present the data. Maybe an additional table that tells us... Basically what you want to do, what you want is another table. Well, yeah, another table which basically takes these percentages, takes the values, and figures out the actual amount. Maybe in brackets, how much percent of the TDI it is. Well, if we agree on what the T... Which value? Case one, case two, or case three. What we're going to do is case one, case two, or case three, right? Or all three. No, no, no. Well, I mean, it's... But to... I mean, you can do it and pick out, you know, highlight cases that are important, like toys or anything else. Sure. I think just do it for toys, not everything else. Because toys are a real charge. And we can also address some of this in our reports that we're writing. Yeah, but what he's asking for here... Yeah. You can't do that in your report, you're right. Well, actually, I'm asking for simplicity. Well, you're asking for simplicity from complexity, which is hard to deal with, with the fact that there's so many different range of values. But it's not inconceivable that we don't... But as you said this morning, we have to somehow present... Yeah, I totally agree. And I figure... Yeah, I think... Sure. That's a table they need to pull out for us and then... Am I on? Can I ask a more basic question before we start talking those kinds of tables? So looking back at the table holder, first point you just to, table six on page 25. Do we need to have some explanation? If I'm looking at, you know, the biomonitoring, median estimates, the Wurmer intermediate intake, the Clark median, which seem relatively comparable. Table six. Table six on page 25. But then if you look at the verse, our aggregate human exposure averages, some of those are in order of magnitude or more bigger do we need an explanation of that? Or have you explained that and I just haven't caught it? We've explained it briefly in the executive summary as well as the main body. And I can quickly touch on those topics. You know, the two main things that we believe result in. And again, the numbers are mainly high for, like, two of the phthalates out of the eight. The others are, you know, within an order comparable, but especially for DHP and DEP, they're really, really high. And we believe one of the things is that when we were looking at concentrations, when we were compiling the data, we looked at all the possible values that we could compile. In some cases, the overall goal was to look at, you know, averages. So if the study mentioned several values, we tried to pick up the average value that they had provided. And then we compile all these values and we then calculated an average out of those average values. But in some cases, the averages were not recorded. In some cases, the only, you know, statistic that was provided was like a high end number, like a 75th percentile or a 90th percentile. And at that point, we just, you know, made the decision that we are going to include whatever data we can find in this table, in this database. So the averages that we calculated include some of these high end estimates. And because we have a lot of values, a lot of concentrations for DEP and DHP, you know, of course, a lot of studies have been done. Some of these numbers are on the higher side. We did have a discussion with Paul and CPSC a few weeks back where we decided that one of the ways to, you know, maybe do a better estimate would be to filter out some of those high end estimates. And we have made a mention about that approach in the report, but we, you know, haven't done that. And the other reason for this is especially when it comes to looking at the human behavioral patterns, a lot of those values were just not available. We could not find it. We spent a lot of time and in a lot of cases we used professional judgment. And most of those judgment calls were on the conservative side, which also resulted in, you know, us getting numbers. So we believe that these two are the could potentially be the main reasons for some of those numbers being really, really high. And these really are averages, not medians, because we've been using the words back and forth. No, these are averages. These are averages. See that now in the last paragraph of the executive summary. I think that's a good, you address that well in that paragraph. Been a lot of time talking about it, but the more clarity it gives you, the better off we are. Can I jump in here? So if we have a look at DHP, for example, the Versaille report for the females had 107, 106.5 and the modified report has 1.7. Is this drop caused, as you said, mainly by new data on the foot side, or is it caused by new data on the toys and tried-cat product side? Yeah, I think it's mostly on the food side, because the exposure is dominated by food. And one of the things that we saw was, if you look at the exposure data, we were using Clark's database that has pretty much everything ever published. And as you go back in time, there were a few very old studies that were driving up the exposures, the averages, and that could have been an analytical issue most likely. But what we decide, I mean, SIRGE was basically trying to use all the data that was available. And that presents, it's hard to combine data from different studies to different quality, different metrics, and so on. And that's a problem in itself. But what we elected to do a few weeks ago at that meeting is we recalculated the food exposures using two data sets. One is from the UK from 2011 that SIRGE didn't have. We didn't know about it. And another one was the next best thing was Page and LaCroix, which is from Canada. And it was published in the 90s, but I think the data is actually from the 80s. And so by using instead of trying to combine studies, we took the two best quality studies. And the, you know, the levels were, the Page and LaCroix, the levels, the exposures are down. What that table you're referring to is using the UK data even a little bit lower using that data. And that's what's shown there. When we get our reports written, you'll have all the information. But we also just looked at all the other scenarios and tried to, instead of using all the data, look at you know a small number of recent high quality studies. Otherwise I mean you can't really, it's hard to average the 95th percentile across a bunch of different studies and so on. But we did it in the course of doing this. We also did get I think a good sense of what the sensitivity is. I mean if you use somebody else's food data you know if you use the Page and LaCroix data instead of the UK data that's maybe a factor or two in the exposure. If that, actually I think it's less. We have a pretty good handle on you change any of these assumptions or the data sources this is what happens. So if the changes in the food route is responsible for a drop from 107 to 1.6 is the statement still true that the majority of the intakes is from food stuff? Yes. Now we looked at everything. Of course one thing when we're talking about phthalates from the toys of course right now there are no phthalates in toys. This is based on the assumption that they are, you know, if they're being used this is what the exposure is. And also in looking at toys you can use the mouthing duration there are all sorts of estimates like a child's total mouthing time is mostly fingers as you narrow the scope that time gets smaller and we used all soft plastic articles is what's currently reflected in those calculations that we have. It's a little bit conservative but not as conservative as the number that surgery was using. But at least we know we can tell you if you change this assumption we can generate many matrices of numbers but we have a pretty good sense on if you change this this is what the result is. So sensitive analysis gives you an idea where your biggest weaknesses are. And we don't have to worry that jeez if we change this will happen because we've done it. So am I understanding then that the report that's in tab 8 is the final report from verse R? It's the draft final we get one more crack but the bottom line is they can't do any new work. We can't have them go back and do like put in the UK data which we didn't have before without having a new contract so that's why we're adding doing that ourselves. So how is that going to be so the verse R report will be an appendix in the I report? We'll still be there but there will also be two memos from CPSC one on phthalates and one on substitutes. Phthalates when we'll explain this. Yeah. The disparity. And our plan all along is mostly because of money is to have verse R do the basic work we would get a bunch of spreadsheets you know the chap Paul whoever wants to you know put in new data or you know substitutes weren't even in the original report. I mean once you had all those spreadsheets you could go back and do any sort of what if type of analysis. But are we saying though that the table when we have a comparison table will the numbers on the comparison table be new numbers that aren't included in the verse R? The CPSC number where it says CPSC that those are the new numbers that are not in the verse R report. And the verse R numbers are the ones in the verse R report. I see. Okay. We're not going to change those numbers. What we're doing is we're writing a memo saying that there's certain data that we noticed in the verse R report which are old and we had new data and diligent about this we put in the new data. And this is the numbers that were achieved. Again you know it all comes down to the fact that there's so few numbers out there. And you do the best you can with the limited data you got. Absolutely. I just want to you know 10 years from now we look back at this are we going to be able to understand where the CPSC numbers come from? There will be an absolute memo in the report that says specifically we did this because we found that. And so therefore there's a divergence between verse R and down to the detail of what was done not just the general. We're drafting the memos. We came up with this plan on what was it January 23rd we met. Whatever date we met. And we decided to move forward. It was felt it was essential. No I agree with that. I just wanted to understand that. No I understand totally. Will that be an appendix? Yes it will be another appendix or sub appendix something like that. It won't be a surprise. The questions comments are so the numbers regarding the routes of exposure after the importance of the different routes of exposure would not change from the verse R report after the CPSC modifications. I think the relative numbers are very similar. So I would propose as we have done for the bio monitoring approach something like a simplification of the results in terms of the roots of exposure as Paul pointed out which are in our focus. We could say that let's say for example 5% of the total exposure route is within the CPSC perspective. This would come down to a daily intake of this and that which would be around 5% of the tolerable daily intake of the reference dose. I think this would perfectly put the data into perspective without being relative in a way. No actually that wasn't that's a previous conversation and right, that's what I think we agreed and we do. This we would have a perfect line from the percentage the importance of the overall routes distilling it down to the point where it's... So you're summarizing what we want to do because we discussed this and I think we're all in total agreement. This was a summary. Cool. I'm not sure we need to do all three cases. I mean just... Pick a case. 1, 2 or 3? 3? 1? Or conservatively you could use the smallest one the minimum of the 3. No, no I want to use 1. Then we're going all over the place. Pick one. It doesn't matter. You could mirror the table we have with the ranges of points of departure and the ranges of margins of safety 1, 2 or 3? That would be a perfect mural. I think that's confusing. If what we're looking at is a relative ranking with respect to an index we don't need all three. We really don't. We're just going to focus on kids toys the ratio of the absolute number for that kid to the absolute number of either case 1, 2 or 3 as a reference. What do you want to choose? I think we have time to sleep over it. But this is not a television show to decide 1, 2 or 3. I think we might make up our minds for tomorrow. He's worried about the tiger behind door number 3. Yes it is. We actually are on TV right now. It's real. They call it reality TV. You want to sleep on it for 24 hours and decide 1, 2 or 3? It's my decision, yes. I will come to this decision. Okay, well calculating is easy. And then it's just a matter of to simplify the presentation. Guys, is it a stupid proposal or is it okay? No, I think it's a good point. So it's just we want to do 1, 2 or 3, not all 3. We agree with you. I try to be a bit critical because Andreas obviously is I don't know he's on medication or something. Somebody has to be critical. I think it's very important because you could look at a very small percentage and say that's not important. But Holger's point is it could be important if the exposure estimate is large enough. You will not get a disagreement out of me on that at all. The question is, what am I using as my denominator? That's the only question I have right now. The principles are clear. The principles are solid. The issue is not debated. The only thing I care about is was my denominator. That's all I care about this point. What is complicated in the approach if you mirror our approach with the 3 cases and the range? What is complicated in it? Because it's the same approach. If you want more simplicity, you can choose one case. I would propose to implement all three of them with the range. It's easy to calculate. I know it is. We can type up a table and if it looks too complicated we can simplify it. We say we're doing this just for toys? Yeah. For the sources of relevance? To the CPSDs? Yeah. It's also child care products. Okay. Yeah. Whatever it is, I use toys as a simplistic explanation for what our charge is. These calculations are based on the Versa approach or the CPSC modifications or... Equal to... Or the latest, whatever. Well, for one where we need to make changes, we'll use the latest and the rest will be... Versa. Well, it depends on whether we have more data. Where we have more data we'll use the more current and that would reduce confusion. As Mike said, we could saturate some data and then simplify it on the way. See what happens. I have a small... So, in the report, I think it was the report, the pie charts on page 31, figure five of the Versa report, will they be in color? Well, yeah. We're discussing that. I don't know. We could put them in color. It's expensive. I mean, it's a question of... I don't even know if this report is going to be printed or purely electronic. One of the issues is getting all those different shades to display. Really? Yeah, well, we need to work on just the mechanics of getting Excel to make black and white pie charts or whatever. So, we're working on that. But you are working on being able to read it even if you want to apply to distinguish. And I imagine that's true for our report as well, if they are pie charts. Yeah. Yeah, I don't know. Anything else? One other thing, the calculations will they be only done for the median or also the upper bounds? Say that again. I do not want to do the upper bounds. And the upper bounds. Just the medians. No upper bounds. Because they're so all over the place. I think that we're putting ourselves at risk. Pushing a little further. May I push a little further? So, when we get to... I think I'm in the right spot. The... What's now section G, which may be moved up, but... So, the conclusions there, it talks about you know, the highest estimate of phthalate exposure to women were associated with DEP and DHP. The main source of phthalate exposure for pregnant women and child-bearing age were food, beverages, and drinks. Can we be more specific? I mean, do we know more about what kinds of foods or what kinds of drugs or what kinds of anything? Is there anything that can... I doubt it. I mean, that's drilling down the problem we can ever go. Does that need to be stated? At that point, we're at the limitation of our... I don't understand why we care for this report. Do I care whether it's apples or... From a consumer's perspective, we have to eat. If you can give me guidelines of what not to eat would be very appreciative. I don't think that's... Again, we're going outside the bounds that we belong. That's something we should just turn over to FDA and EPA saying, here's what we found. Food is an issue, and you have all different types of food and food processing issues. It's up to you to deal with it. I just don't think we're... I just think we're way, way out of bounds there. But Paul, even just stating that's beyond the scope of this analysis would be helpful, maybe to limit it, you know? The bound on what we can say about this. I think there are other papers have suggested that it's more like fatty foods and dairy. Now, I think some of that may be in the analysis that Kent did for the food. So, yeah, it's going to be in our memo what are the main sources in terms of food. So, it is going to be that, yeah. And for, I mean, the other sources is... General classes, nothing... Very general. I mean, it's going to be like meats and dairy or something like that. I'll go for that, but nothing more because we're putting ourselves at serious risk because we really don't know what's causing it. Maybe unfair to the public. Member Chris, this is historical data too, so... Yeah. If having it too specific wouldn't be relevant to 2012. Right. But again, the point is well taken that for the consumer we should know but I think it's incumbent upon other agencies to pick up the ball and run with it. And, you know, we don't want to over... I guess overstate it and cause a panic. Yeah. Yeah, the newspapers would take away with it. Hmm? Serge? Yes. We're just wondering if you're still with us. Yes, I am. Do you have anything to say? Um, no. You know, Chris brought up a whole bunch of good points. Yeah. I think this is a very nice report. It's clearly a lot of work trying to put it down in papers even harder sometimes, so... Yeah, I think that's very true. But, you know, it was also a very very interesting, very challenging and very fruitful effort, I think from our part. But I've been making notes and I think I have three things in my list that, you know, need to be addressed and they're mainly in the form of, you know, just adding text to the report. So, you know, I can do that and Mike, I will try to submit it to you as soon as I can. Oh, okay. I mean, we'll we're still looking at it, so we may have a couple of things too. Oh, okay. Okay. Okay. Thank you, Serge. All right. Thank you. Thank you very much. Thank you for your patience. No problem. It was a pleasure. Thank you. Thanks to everybody and, you know, have a nice day. Bye-bye. I think we'll move on now to look at the recommendations. Okay. So, if you will all turn to Mike, I don't know whether you have these that you can pull up. Okay. Now what I'd like to do is to use the information that we talked about this morning and this afternoon and apply that wisdom to the recommendations for each of the phthalates and phthalate substitutes and see how far we can get this afternoon and then hopefully finish up early tomorrow morning. So, yes. But before we do that past tea time, we'll take a tea break for our British colleague. Yeah, but it's well past his tea time though. And reconvene, let's say in 20 minutes. Okay. You have to take tea seriously. I do. My wife drinks it all the time. All right. Welcome back. Let's spend the next hour starting the recommendations on the how many phthalates and phthalate substitutes. So, tab number 10 and we just to refresh your memory section has the criteria. Do you remember what section that anyway, that's we had agreed on the format that you see on this first one for dimethyl phthalate where we go with the adverse effects animal reproductive developmental human and relevance to humans weight of evidence, experimental design replication risk assessment considerations exposure hazard and then number five is recommendation and then point six with this recommendation implemented be expected to reduce exposure of children to in this case, DMP and so we filled in one through four and now based on that I want to do is complete items five and six for all the phthalate and phthalate substitutes the criteria are in tab three page 57 but they're pretty much that. I'd like to take a few minutes to just read over information on dimethyl phthalate then we can discuss and begin filling in the chap recommends and put in some context and these were drafted I forget exactly when but they're I'm not sure they are the summary is flex what's currently in the chap report although I don't think if this information would have changed much well there is biomonitoring mentioned there so sounds like we need hovers table to picture that in percent toys that maybe two percent what percentage of the daily intake is that is it a hazard index one below one that would complete the puzzle we have DMP it's not in it's not in we could even take it out well I would leave it in but also the margins of exposure is it from some preliminary work or that I I where did that come I think that's probably from couple meetings ago when we first raised the the margin of exposure I think we took it out because we have problems fixing a point of departure for section oh yes yeah that's it under weight of evidence to it talks about a no al which we don't really have I think at one point we were using 750 milligrams per kilogram per day as a just a value but we've moved away from that now just a quick question there's a couple of abbreviations here which are funny in my opinion what's capital mk on a animal adverse effects developmental if you go up the page before I think it's milligrams per kilogram yeah could that not be written like that well I think it being well yes it's milligrams per kilogram per day well there's an mk and then there's an mkd the mkd mk is this a new generally recognized abbreviation which hasn't yet filtered through to Europe well I I haven't seen it in print I use it for shorthand that probably should be mkd the more usual way of putting it instead of the mkd well yeah I mean this if this is going to be in the reports we can certainly edit it and Phil there's in terms of no human no published human studies they did measure MMP I think in the swan study in one of the other AGD papers they didn't find any associations but it wouldn't yeah so it wouldn't be correct to say no published well you could say no associations found and I can look at I think it was a swan and I'll look right now Mike do you want to to well if I may kick it off here I think this is a fairly straightforward case there's no case to answer right wouldn't you agree yeah and so the recommendations are permanent ban interim banned or no action at this time well I'd say no action at this time no action at this time yeah make more of it sorry I didn't say that no action I'll let it slide as long as you stay in front that makes .6 moot yes absolutely being back to seriousness but just as in terms of style so we spent the morning talking about you know hazard indices for the mixtures and etc etc but then there's no mention of what are the mixture part of all of this do we need to make reference to um I know we're doing individual chemicals but this wouldn't be part of the mixture that you considered right it wasn't included because we didn't have information about a reference dose right but just in terms of a style for but wouldn't pertain to this one maybe I'll hold my question until we get to that yeah okay moving on to you get the swan study in there Mike or yeah I just wrote a note to add it in at some point okay so it's swan at all suz uk I'm moving on to DEP valet the first question I have we're doing tricky issues is it in terms of our charge specific charge kids toys and child care products are we looking at that as being a major source because it's not here in the statement we haven't said anything about it zero well it's it's well from toys it's zero yeah see that's when I looked at DEP I remembered that that's pretty much zero well if we look at the moms it's a little different moms has a little bit of influence for cosmetics it's not my mistake it's mostly cosmetics and drugs can be high if you depending on what ones you're taking but drugs is outside the realm of our purview as well as cosmetics well drugs and cosmetics are out of outside of CPSC's purview it's there but the update the exposure section on this one you're on DEP now and the human would need to be updated too I think Bern wrote this and these are focused on well at least the first three the semen quality studies which are really deep in the appendix just a short paragraph and I'd have to look through the AGD and the neuro studies because there were some associations in the neuro studies but the question is how much detail do you want here because it'll repeat what's in the short part of the epi session section do you want bullets like this or more of an overall we're going to use our judgment based upon everything that's in this document to make this recommendation so I don't think we need to have exhausted detail here I can do that between now and tomorrow morning when we meet I would draft a few I would enumerate I would give every study the effect and the effect study and effect at the end the effect basically what they found with association you say there are states in addition to the four that are listed here I would scratch the first three those are the semen quality studies that we haven't even focused on in the short report part and I'd focus on the neuro developmental and the AGD papers I'll look at it this evening but it'll be a little difficult because the Mount Sinai School of Medicine studies they use an exposure metric of low molecular weight phthalates which are in this case are largely driven by the MEP but it's not only MEP so it's hard to then say there was an association between MEP and whatever it may be neurodevelopmental tests there would be more there's an association between low molecular weight phthalates and such and MEP is a major contributor to the low molecular weight phthalates well if we flip the questions around at the end would this recommendation reduce exposure of children I think the answer to that whatever we recommend would be no it's not extremely relevant in toys toys and kids personal care products and also the products that women use that are under the jurisdiction of CPSC what about personal care products personal care products are all under the jurisdiction of FDA they're a significant source for women and even for kids so what do you have jurisdiction over exactly we have jurisdiction well not food, drugs, cosmetics medical devices or pesticides we do have teethers toys home furnishings construction materials in your home so maybe we need a statement for the materials that are under the jurisdiction of CPSC which include A, B, C, D, E, F and G for the reductions in children for the reductions in children however this is a meaningful phthalate and other agencies need to consider it seriously in their evaluations of their products under their jurisdiction I like that very much in that way we protect ourselves by saying this is not a trivial issue but we cannot force other agencies to take hold of what we think is a problem and at CPSC is not the bearer of the bad news because they are not in any way shape or form the highest percentage or wonderful I couldn't agree more let us craft language right now and just to answer Paul's questions home furnishings air fresheners paints and adhesives the air and duster indirectly could come from products children's teethers and toys things like changing pads and play pens rainwear rubber gloves but for a lot of these I mean you are talking air freshener paints and maybe paints and adhesives I don't care about the individual chemicals what I am saying is that we need a statement saying what your concerns are for the products that are under CPSC jurisdiction and list each one of them our recommendation is X and then for this particular chemical we do note however there are significant exposures to this chemical and that it has toxic implication whatever word you want to use Andreas and that the other agencies and organizations which deal with products that are listed here under total exposure or risk have to be evaluated I think we need to indicate for each valley where the exposures are coming from that we know about if we can and which agencies need to be concerned I think they are in a report but I think we can't list them all because we don't know which agencies have jurisdiction because like EPA has some jurisdiction on foods FDA has some jurisdiction so any more specific categories okay Mike can we craft language then point down to the 0.6 I mean having agreed on a general direction wouldn't it the alternative instead of drafting something now would be to delegate to panel member and tomorrow we revisit that so we have time to go through some of this but carefully while we're on our own and then would that be instead of doing it now which will take a lot of time okay Holger wants exercise then let's do it for one substance I'd like to back up though to number 5 before we jump to number 6 because this is a chemical that's I think we've got a little bit of a split information I mean it seems to be that there's stronger human evidence of risk than there is based on the animal studies I mean this is one of the chemicals that we actually took out of our index because we couldn't decide on an RFD for this chemical so do we need to address that issue I mean we were going to put that off until we looked rest of that section on the studies that were relevant to the human exposure remember we were going to but I thought that there was through that discussion I thought we said that there was some evidence of associations am I overstating that but then when I look at the animal stuff here you know the last sentence for the most part these have not been confirmed in animal studies right I thought we were going to wait until we had those bullets for the human studies before we so we knew exactly what those were I mean I can tell you briefly now or I can put it together and we can look at it in the morning I mean what's your choice but I agree Chris that this is this will be an unusual case because the animal data suggests that that there's no effects and in a few of the human studies there's associations so I guess so your point is that the human studies may be neurological and not well swan in the swan paper they did find associations with decreased AGJ with MEP and then I think two or three of the neuro studies as well I'm starting to put it together now but I don't think I'll finish before well that's at Hogan's urging let's go back and develop that text under six Mike was that verbiage that you began to develop brilliantly do you want me to write it up thanks now I'm supposed to write that up plus I have something you're supposed to just verbalize it and Mike's going to type it I'll write it it's so short I can write it up tonight okay then I might start for the articles or items under the purview of CPSC there is no exposure reduction expected by eliminating it by elimination from these articles or items however given the level of human and toxicity data and the exposure from other sources food, drugs etc it is urgent that other competent authorities in the U.S. I conduct a risk assessment for DEP I don't even have to mention it right now food, diet pharmaceuticals pharmaceuticals food supplements fool supplements are like that etc etc there is sufficient toxicological and human data no I would say however for exposure no however exposures from to from no exposures from personal care products to the chemical from if you lose the products such as okay yeah that's it from are substantial or can be substantial there you can lose as well and then full stop can be substantial full stop and then there is there is a case for other for other competent authorities in the U.S. to conduct sorrow risk assessment for DEP especially for women of child barring age is it worth making the point that the although we haven't selected a reference dose from this but there seems to be evidence that the potency of this chemical is going to be much less than other chemicals but the problem is the exposure is so high do we need to frame it in that sort of I would say this formulation would put the ball firmly in someone else's backyard and you know what you've just framed is precisely the risk assessment question but I'd say it's not for us at this stage to advocate any further it's I know this is a bit of a tactical approach but I would I agree I wouldn't say that because the statement you made is based purely on the animal data right in terms of the hazard let me just be very blunt then did we make a mistake taking it out of our analysis like you misspelled authorities sorry yes does it show so what are we recommending further action or what deferred action this is a case where it's not that the animal data are negative it's just that there really aren't except for the gray study yeah the gray study went out to what 250 milligrams per kilogram per day and did not find significant that was to one dose yes right control in 750 so there is some evidence that it's less potent than others yes it wasn't a dose response so we don't know had there been a dose response at what level there might have been a response other than that study the other two developmental studies were not done at during the window of sensitivity so those are really not useful could we point that out though because this is it's a little bit I'm worried about this section because we've completely dismissed it in the earlier sections and now we see oh look there these three studies that's contained in the appendix but here could this say these are not in the window of because it looks like there's a no al from kind of a quality evaluation it is look at the experimental look under weight of evidence experimental design the other identified studies have lower confidence since the dosing route in one study was not relevant to the anticipated human exposures in low end doesn't say that they didn't I can update that I was looking in the wrong spot but yeah I think that needs to be wrong there just spot a contradiction I'm sorry it's if you look under one A animal and then a small A last bullet point the paper by Oishi and Hiraga 1980 it says there they conduct a short time study and where decreases in serum testosterone were observed after exposure to DEP if you now turn to number three weight of evidence under A second sentence there it says in Oishi and Hiraga increases increases in testosterone are reported so yeah that's I don't know one of them one of those is wrong well one of them is right that's on what side of the pond you're on yes I don't know I'd have to that's in burns I'd have to look that up so in the text here when it refers to CHAP suggests that the male reproductive effect has a no al of 750 that's not that needs to come out under section 3B the last sentence I don't know where that came from I think these are still footnotes from your people Mike is it well yeah I more as a footnote from I mean Kent did this a while back so at one point we were using 750 just because we it was the best we could find as a conservative value but then we decided that that's not good to use so right I think so I mean too also the the last sentence of the exposure section 4 talking about margin of exposures I think that was earlier work that we now aren't using I think we should get rid of that too the section 4a the last talking about CHAP calculations and Haynes biomonitoring data with margins of exposure Bill I had more of a I guess bigger picture question just I was just looking ahead to the BP and if you look here it's two pages ahead you have ten bullets for reproductive fifteen bullets for developmental human I mean are we do we want this level of detail when we get to the recommendations because for some if you look at the BP which is next it's basically reiterating most of what was said in other parts of the report in terms of going through each of the animal studies and each of the human studies again it's just going to be you know if you do this with six or eight phthalates you're going to be saying same thing over and over and you can see with DBP you know you have four or five pages single space so it is a convenient organization though to have you know if you're going to look up like chemical it's all together instead of having people read through the whole thing it is redundant yeah it's very duplicative and then how short do you want the bullets because some of the bullets are looking again at the DBP you know you have six or eight lines for each study and others you may have a line or two is there kind of a format that we may want to go by or to shorten it in a way because I think otherwise I think this was written a while ago as well so I think each bullet is going to be have to be double checked which what was written in the short report was the appendix to make sure it's apparently consistent I mean we already found that with the DEP that OSHI study you know one said it went up one said it went down and I will do that I will make sure these agree and I will go through I noticed that the bullet on these aren't paginated for DBP on the second page the top one is you know it's quite long yeah so did we want to think about a format or could we just you know some of them include day of dosing and multiple doses others include very little detail but it has to be consistent could we just say you know the chat in whatever section reported on blah blah blah number of studies and just summarize you know they found are the best studies of those we considered were such and such I would prefer that especially as you work your way through the book I didn't go to DEHP yet but I bet you that's going to have 40 or 50 bullets hmm right so some kind of short summary that there were such and such animal studies and the overall conclusion was yes decrease testosterone or no not something like that if there was a noel then that would maybe report that if there's human evidence yeah there were you know of the seven human studies two found or four measured MEP and two of them found an association with such and such and leave it at that but I leave it to the chap and you know I just wanted to bring that to your attention and I will do that but I think we can still go on and do this with what we have but I'll go and try to shorten that but you do want a bullet for each study I mean look at the DBP you do want to oh you don't I will go and do what Chris suggested but I mean in terms of our deliberations today and tomorrow we'll just deal with what we have here to make our recommendation and I'll go through and shorten the the same with the human it'll be more of rather than a line for each study again it'll be a few lines together summarizing what was there or what wasn't yeah okay also the exposure part can be shorted each a data on our subsets I think ultimately each of these recommendations will be a page basically very easy for a reader to take what the rest of the reports said that's there and what the recommendation is let's go back to the DEP and talk some more about this in terms of where we don't essentially have any animal data one study by Gray where we don't have a dose response and the highest dose didn't give us any effect but we have human data what do we say human data is important so the tox data is only in lieu of human data correct in my mind the human data is the driver we have no human data then toxicology does rank higher I agree that's very relevant in the case of DEP and that's I think why as we have now suggested we should recommend that the other competent authorities look at that in in very great detail I agree but I mean what given that what is our recommendation for point five what are we going to recommend to ban not ban or no action well those are our choices how can we ban something in toys when there ain't nothing in toys well that's an issue we need to talk about I mean we are given those are the choices that we have I think we should think about the bans or not bans based on public health and then come back and talk about it on specific products and it shouldn't be six it should be five and then six well well I thought that we discussed that we can the recommendations which we have to make that's how I interpret our brief are in relation to articles under CPSC's purview that being so we cannot say then we would recommend no action because it's not relevant to CPSC jurisdiction well we can say more but that's first of all the bottom line we can interpret it unless I totally misunderstand things or I mean the other point to address here now would it be meaningful for any reason whatsoever to put DEP into children's toys in the future but I can't answer that that's a question for the experts if there's any meaningful prospect of that then of course we have to rethink and we have to consider this case that's likely be used in toys because it's a low molecular weight but yeah I mean we're dealing with complex issues one is you have a ban but that ban has to be specifically designated as Andrea says to the products we have under purview if we were looking at from another point of view we may not say no further action so we can only say no further action based upon the limited materials and products that we have in our purview however the issue of ban does have to be shifted to somewhere else because they have to consider what the heck the the magnitude of the exposure is in these other products there are other tools before you want to ban something replacement there are other risk management measures available for you to reduce exposure we could stick our heads out of the window and say under recommendation that we we think because of the evidence in humans and the effect profile that exposure reduction measures are urgently called for that's all but as far as the our remit is concerned no action because it's irrelevant I think it's important to clarify whichever statement you make if you say no action is recommended because DEP is not used in these products or if yes I think it needs to be emphasized too because someone could read 5 and not read 6 but I think if you went the other route and you said that the chap recommends that DEP be ban from use or whatever I mean use that term it would then have implications for other agencies that regulate excuse me DEP and personal care products and other situations right and at this point we can't do that because we don't know what the regulatory requirements are what their boundary condition what their criteria is we're basically in a theater of the unknown at that point we don't know what EPA's constraints are we don't know what they're doing well apart from that if we said this the chap recommends based on the suggestive human data that DEP be banned no I didn't say that you didn't say that no I think that's very important the question of a ban is a complicated one in these other areas the key you have to think about what do you want to achieve a ban is a tool it will achieve expert reduction but really you want expert reduction but you can get there by other means banning something is the ultimate the last resort else doesn't work but it's not for us and it is indeed a very complicated issue to decide whether in these areas cosmetics, pharmaceuticals particularly complicated whether a ban would really achieve anything or whether other ways of dealing with it are viable I mean that's something to decide and discuss that's definitely I think beyond our remit but what we can say in my opinion it's expert reduction is in our opinion indicated right but Phil said we had three choices right for the recommendation but then as we described then say very clearly for our purview within our remit there's no point recommending any action in relation to toys however we're looking at toys we're not looking at in terms of banning the substance the whole concept is in toys because that's what our charge is the fact that the mandate says to look in risk assessment and all that stuff just complicates the fact that we have to consider all pathways but we have no I agree completely but if our choices if those are our three choices we need to qualify we can't avoid making a choice if it's ban the choice is no action the choice is no action for the items under our remit for a stop and then a big however in bold I think we have to put it in bold considering the fact that total exposure is a public health issue and there are other there are other routes and products that contain DEP responsible agencies or responsible parties must evaluate these things in terms of whether or not they want to do any kind of action whatsoever we can say it more clearly but the key thing is is that we have to we have to kick it down the road also have to say something specific as well not just push it off because I think Andreas your question is really critical in terms of would DEP ever be used in children's choice because we're making a decision in a point in time and if you just left it very vaguely as no action that could be interpreted as DEP saying that it would ever be used in the setting but it could be I would like if it would make sense I would be inclined to say something like DEP that we think it should never be used in children's choice but my technical expertise and here because that statement might reveal us as technical idiots because everyone familiar with this topic will immediately say DEP will never ever be used because of its chemical properties but I can't say that I have to call on my friend Holger Paul to help me out and Mike to help us out here I think it's unlikely to be used it wouldn't be used as a plasticizer it would be used as a solvent I mean we have had things products with methylene chloride and other solvents inside and if it breaks it can leak out but I think with this document with the six bullets I mean I think it was drafted put together with the intention of deciding on the recommendations to the commission do you ban this or not it's complicated enough because you have to weigh the cumulative risk with the individual chemical and then you're adding to that the other you know what do you do about the total human exposure that's not in CPSC's purview so it's a it's not a simple exercise are we stuck to these six levels can we add a 5a and a 5v and 5a is public health and a 5v well I think that's up to the chap I think Byrne came up with this as a way to help think through all of this stuff but I think it doesn't address the issue of the individual phthalate versus total exposure or total cumulative risk and it also doesn't I mean that's fine if you want to have an a and a b where you do the things for the commission and recommendations for everybody else that's fine I think that's what we said we didn't call it 5a and 5b we said it was however for the material under the purview this is our conclusion now however that was report b from the standpoint of public health this issue and has to be evaluated by other agencies and I think that's about as far as we can go I would just reorder them because our permission is to do things for CPSC first that's our goal anything we do beyond that I'm looking at on page 3 of this document it's talking about we're supposed to evaluate potential health effects of each of these phthalates that doesn't say each of these phthalates based on toys of these phthalates so I would suggest that part 5 be first of all public health evaluation overall assessment there and then come back and say now how much of that is due to children's toys so we can do that in other parts of the report and I think we can well do that but this is now about our recommendations this is about CPSC recommendations not public health recommendations I think we're in a community though in an environment now with the EPA where it is in that we have an opportunity to say something a little broader than just the narrow CPSC and I would like to take that opportunity but we will do that we will do that but not in we've just drafted something saying over to you there's a case to answer here but I would say this is now about our recommendations to CPSC we shouldn't muddle these things because it's covered partially in 6 it's written there I think but I had a hypothetical question which you love those so if DEP was contributed 1% or 10% whatever to daily exposure from children's toys what would your recommendation be can you turn on your mic out with it do you agree as well child care products child care products are not under their purview it's under what you call it depends on how you define for us child care products could include things like play pens we're not talking about the de minimis objects we're not talking about a severe case of pica to even consider we're talking about any kind of detergents but based on the hypothetical question I compliment what would your answer be I would agree as well but based on the hypothetical question if so far 3 of us have answered to that I think it's then important and I think what Chris you're getting at in that recommendation to make it clear why we're saying child care products are under action but I thought we had achieved agreement on that already we're going to do that I didn't agree with that I really think we have an opportunity to say something about public health I think to come out in the first statement and say something about a smaller purview it misses the punch this is the recommendation to CPSC for their products I don't think so because they're going to ignore that first statement and then they may ignore everything you want them to ignore everything because you're going to say public health and they're going to lays over these are not scientists these are people who are here to have a mission as commissioners and we have to lay out for them in a logical order that they will understand I think it's unfair to them to do it in an order that meets some public health gain that either us would want I don't think it's fair could you change instead of just saying recommendations could you make it more specific and say recommendation regarding use of ex-thalate in toys and child care articles because then it's clear what you're making a recommendation that would help rather than this because recommendation can mean public health child's toys everything but if you say basically a recommendation regarding the use of ex in toys and child care articles recommendation to CPSC yes so it would be very specific what that recommendation is in regards to yeah right but it's not written there so it could be misconstrued but where are we saying the broader statements you say we could say it somewhere else where else are we saying it what was written Mike Mike wrote in red and six covers see I think what he wrote in six is fine but it's pretty much saying other people need to do this I mean we've already gotten to the point where we're looking at exposure we're looking at in this case the DEP may not be the right place to have this argument but you know there are some cases it's clear I hate to just kick it down the road that's all I'm saying I think it's just a matter of where in the document to put that you put it here or do you put it separately do you want a separate section for CPSC or even a summary of the CPSC recommendations to highlight it or do you want it to go by chemical like this is a section though that's going to be very simple to put it all together we can go on I just Mike is this approach we were to complete this and have some verbiage here that explains why we are making these recommendations is that going to be useful to CPSC in terms of what they have asked us to do and what they then have to do with our report well there's let's see as far as what CP well the bottom line is you're recommending about the use of things in toys and child care products so it's going to the meat of this is I think when we get to a little bit farther down the list but I think in terms of what CPSC needs is they need to know what the recommendation is but more importantly why so for example if it's a balance of a little bit of exposure from toys and a lot of exposure from other things whatever you recommend I think that has to be clear what that what the risks are you know something like a hazard index what the sources are if it's coming from sources other than toys and child care articles so I think that has to be in there for for CPSC and I had a minute ago I had the language from the guidance from our general counsel about would it be necessary I guess the commission will have to say is it necessary whether it's necessary for public health to do this ban and I think that was the word necessarily necessary to protect the health of children specifically which speaks to our point six we have the bullets uh either individually or in combination capable of producing uh injury or illness to children and then of course the the exposure risk part is it can that happen I mean yes if you mix these things together in the right doses it can cause injury or it's likely to but then the second part is this going to happen from reasonably foreseeable handling and use or in other words is the hazard index going to be greater than one or something like that or actual products neither one of those mentions toys um yes but the bottom line for the commission is whether to regulate these things in toys and child care articles that's not uh yeah so our still our format will give you the information if we are specific enough in points five and six we should be able to answer these bullets if you read on further there it says the last paragraph to be restricted from use in children products yeah because they present an unreasonable risk of injury to children and if so it would level and why well there you go but it also addresses Chris's point bullets up above where they are not limiting it to children's toys right and and I mean that's I think it's not very clear from the CPS that you're going to do both what you give more emphasis to it doesn't say I mean that leaves it to the chap but one I mean just just one suggestion said well what if you know this is the exposure in your below a hazard index of one from everything else in the consumer products the toys tip it over you know if that's true presumably that could be a justification I think when we have discussions on some of the other valets this this is going to be yeah I mean this diethyl is not the best example yes I mean it has to be said that everything has been let me say quite ambiguously drafted you know starting from from the charge coming out from from congress to everything so that means so during the years we've worked together here on this that has meant that we have to define it a little finer ourselves and along those lines I would say we should phrase these recommendations in relation to articles under CPSC's remit but I agree I fundamentally agree with Chris that we can also make some statements in the direction of other competent authorities the advantage of ambiguity is that you have to decide what it means maybe someone extremely clever did this well maybe should we take a break I think we shall break for today and convene again tomorrow at 9 a.m. thank you all thank you see you tomorrow morning