So, let me ask a Clapham type on the bus, a type on the Clapham bus in London as we would say, kind of question, right, okay, so Joe blocks on the bus, you know, so listening to you, it is a, well, with qualifications, a reassuring message, so would you think your data are strong enough to say DBP for the human is totally harmless, no worries. I think that the one reason why we couldn't say that is that if we said that we would be presuming that the data which we've generated which we think is convincing that that's also representative of what you would find in the first trimester, but that's based on presumption, not evidence, so I don't think you could therefore make a statement as, you could make a statement that was that we would probably, or sorry, I can't speak, I would probably be reasonably confident in that remark, assuming that our results are also are equally applicable to first trimester fetuses, but you would like to, you would like to see the direct evidence for that, so, and I don't know what stage Rene Haber's work is in, I've tried to find out from Ben Argegu, but you can't ask Rene, he doesn't, he doesn't let on about what's happening, so. Also, you didn't actually qualify your question with, in terms of fetal human, you were answering with that presumption. Joe blocks on that bus wouldn't be able to do so, but. So, you know, at least, you know, I think the work we presented is in the fetal period and restricted to that in terms of our, yeah. So, so in other words, for to be, to be more certain about the, the regulatory implications of your work, do I understand you both correctly, you would require data from fetuses, from a much earlier period, in addition to what you've already researched. Yeah, I, I think similar data to what we've shown and using similar methods, I think if, if that evidence was there, then the only reservation you would then have is whether the Xenograph system is completely unrepresentative of the fetal, fetal testis in situ. And I think we've, we've no, we've no evidence that, that that would apply and the Marmoset data would suggest that it's a reasonable assumption. Yeah, I'd agree with that. I, you know, I think the small amount of data that we do have with regard to the earlier first trimester window is consistent with what we see in the second trimester as well, but there's a lot less data there as a bottom line. So you've done a little bit there, we have, you know, a couple samples from there. So it's consistent with low response at that time period as well. But we just don't have as much certainty, as much information there. And it is clearly limited to the model that we have. Based on your data, both of your data, would you therefore advise to reconsider the current RFDs or TDIs for the respective delates, the HP? You're really asking then the risk assessment question around what kinds of allowable exposures are reasonable in that time period based on extrapolation, current extrapolation from known response in rat as a bottom line. Should we reconsider that? And those risk assessments now are driven predominantly by the light Excel testosterone response, because that seems to be the most sensitive endpoint in the rat model. Is that, is that correct statement? In the US it's different, but some of the European TDIs are based on these facts. So Richard wouldn't currently be based on his expertise. He himself in the position of advising the respective committees to change the TDIs. You're telling him that? I think what I would say is that for all the relevant studies that we've done, they've only been using a single high exposure dose. So I don't think you can really draw any conclusions on that other than the fact that we don't see anything with that dose. So, but I'm not so sure that I would say that you should use that dose to actually work out your TDIs. I don't know, but that's, I'm getting out of my realms of expertise there. So other people need to be making those decisions on me. We've, we have looked at a range of doses and have not seen any, any responses in the human tissue either.  I think what's kind of striking about the two systems of xenografting that have been presented here is that they really are quite different and yet end up at the same point in terms of observation of effect or lack thereof. You know, so a model of six weeks with human chorionic anatotropin exposure and then a very acute model that we've developed. And it's kind of satisfying that you get the same response or lack thereof given those two very different approaches. That's somewhat reassuring to me. How strongly you bring that into the risk assessment process, I don't think there's any precedent for it as a bottom line. So you get to pave the way for that yourselves and think it through yourselves. You know, there's a weight of evidence approach that has been generally applied to how you use information from different species and you bring that to bear. And, you know, the xenograft model has never been given a weight and, you know, sort of experimental human studies have never been given much, you know, have never been awaited in that regard.  But that's actually a very complicated in general, how you weigh in epidemiologic results from human with animal studies, you know, becomes really quite complicated. And it's an art, I'd say, at this point in an uncharted territory for you. Still not answering your question. Because we're whatever we do with the data that you've given us today, we're going to have to defend. And so one of you, I can't remember which one now said, a question you have is, is the xenograft system representative. What caveats do you have in terms of the system? In other words, when you submit your data to for publication, what sorts of things do you say in your publications to head off criticisms that you know might come from your peers about the system? Because it's not, it's an artificial system, obviously. It's not what a test is normally sees. So what sort of things do you concern you as an investigator using that system? The great question I'll start off and then I'll let Richard weigh in. So in the model that we've used, it's very acute. And so that creates problems right away. You're moving a tissue from, you know, an intact setting into a model and looking and doing things to it very quickly. So there are some advantages to that. So we can compare actually the response in rodents where things happen very quickly to humans where they happen slowly. But the result is that we're looking at only a very short time window, where adaptation to that new environment may be coloring the response that we're seeing. So that's a concern. The hormonal environment in the host is obviously different than what one would experience in utero in an intact system, whether it be rodent or human. So that environmental setting is, you know, a concern as a caveat for the system.  And that, you know, so we're working on that. But that's a deficiency in our model. You know, I think Richard does not share that deficiency in his model, which is reassuring. So you know, those I think are the main caveats that we have. Yeah, I guess that I think it is when I maybe I said it, but it's just a general caveat. Because I think that you know, what we were doing when initially when we were setting up the system was to validate it in terms of normality in so far as we could demonstrate it so that the cells that you expect to be proliferating or proliferating by functional measures that we have, the cells appear to be functioning normally. And particularly, as far as we were concerned, that the germ cells are differentiating as they should be, because the primary remit was as as model for the origins of testis cancer. And if the germ cells are not differentiating normally, then you can't begin to intervene to make things go abnormal. So I think all those sorts of things, all the boxes were ticked.  And I think the reason why I would have a general caveat is that the more we use the system, the more we get to know, then I guess, the more likely we are to uncover the deficiencies, its limitations. But at the moment, we don't really have a handle on those probably because it's too early days. So at this point, vascularization is not an issue for your system words, which is more long term. Is that correct? I mean, we've not specifically looked as Kim has done at the vascularization. But clearly, there are blood, there's a blood supply, and the testis are growing. And as I say, they're behaving at least semi normally, as far as we can tell. So there don't appear to be any problems on that front. But how normal that is, I don't know, I don't think we could say you don't ever observe any increase in appetite excels, for example, which would be an indication that they weren't receiving appropriate nutrition and oxygenation. I'm trying to think, I can't recall that we do, because we will be a bit alarmed if we did. But I wouldn't like to say categorically that we've never seen it. I just can't remember anything a concern like that being raised at any stage. So, you know, we've looked for that specifically. And we do see in the center of the transplants in the early time period. So day one, day two, apatotic cells, and presumably ischemia related, you know, perfusion related problems. And that really does go away with time. So it's probably vascularizing during that time course. The vulnerable areas have died off, and then you get proliferation replacement. So that is an issue. That's part of the reason that we were doing the time course is you have to look at what the changes are throughout that time. But it is restricted to, you know, sort of the middle of those tissues. Yeah, I may be the only one here who doesn't know what many puberty is. But I would benefit from knowing more of what you meant by that. And what does it imply for vulnerability or lack of vulnerability? And does it go across species? So it's it's something that's generally looked upon as being primate specific. But I think that's maybe not strictly correct. I think that all male animals have some sort of period like this. But I think that's only in primates that it's an extended period that you can sort of clearly define. So for example, I think in rodents, you know, you get a literally a burst for in the first 24 hours after birth, that might be the equivalent that seems to play some sort of role certainly in brain programming. But it's at a different stage in development really than the would be equivalent for the for the human at that stage. I think in some of the domestic animals in sheep and cattle, there's there's slightly more evidence for period. But it's, again, it's not prolonged. And it's not as well defined as in the human primate, where it's something that's very, in terms of steroid production, genital activity is male specific, you get elevation again, out of trophins in both sexes. But you only really get the the gonad responding hormone production in the male. And it's so you get testosterone levels that are into the adult range in humans. In I always sort of like this idea of this, this little baby being breastfed. And yet it's testosterone levels are probably as high as its dad's. But the it's been a real mystery as to what the what the role of that hormone is, because people have done experiments where they've obliterated it in primates. And in one or two speeds, it's been done, I think, in about three or four different primates.  And the others not. So there's some sort of bits and pieces of data that might affect immune cell development. But I think overall, sorry, there are, I think, well defined effects now on penis growth, and so totally cell proliferation, which are sort of quite obvious. But I think there's always been the suspicion that there's another purpose for it. And that we just haven't been looking for it. We don't know what to look for. So if we knew what that was, and it was something you could clearly measure, then maybe you could be, you could begin to investigate it. But nobody has any clear idea at the moment. So, Burn, I'd add to that.  I think it is relatively understudied. And little is relatively known about it, particularly in humans. So I got interested in this a number of years ago and tried to find out how much information there was about what the testis response is during that time period in humans. And there's very little. There's some hints of initiated spermatogenesis occurring in the early postnatal period that gets aborted and testosterone levels being elevated. But the implications of that overall, in terms of physiology, I don't think we have a very good idea about, as Richard said. I think now we moved away a bit from the risk to the hazard. So would you still consider the phdelaids a reproductive toxicant of relevance for humans? Or would you still consider the phdelaids an endocrine disruptor of relevance for humans? Andreas? I guess all I would say in that regard is that, you know, when we had no data, the default assumption is that the animal results are relevant to humans. That's the default assumption. As we are learning more, the certainty of that default assumption becomes less. I think that's all we can say. I'm not asking these questions because I'm particularly mean, but because we have to answer questions that are particularly mean. So Richard, is this your opinion? Yeah, I think that's a sort of a fair summary. I think it would be difficult to put it stronger than that. What is the summary precisely? Well, that the default position, as Kim was saying, that the rat data tells us what will happen in the human to that is that's become more suspect and therefore we would no longer think that that default position should be accepted completely. It should be looked upon, if you like, with a little more suspicion. The idea of actually trying to get the information that would allow you to remove it completely perhaps. I think also maybe that there is the additional caveat that I am concerned now that that there may be that we may be looking at the wrong age for the effects, which I think would have been something that we simply wouldn't have thought about because all along the assumption has been that it's fetal effects that are going the biggest concern. I don't like to be the most irreversible in which the rat data, of course, said were there or likely to be there in the human. Maybe I can try another summary from taking a slightly different perspective. What am I right in thinking the new findings you presented would suggest that the action with one thalite is a little earlier before the male programming window starts by mechanisms which were very unsure about number one. And secondly, the action is also much later than we originally thought, i.e. in neonatal life. Also by mechanisms we are very unsure about, but phenomenologically the neonatal effects are clear. It's a suppression of testosterone synthesis. So in short, the old thinking was it's all happening in fetal life inside of what you refer to as male programming window. And I think that is still true for a lot of other and the androgens, but maybe not for certain thalites. So your results show it's happening slightly earlier than that or something is happening, DBP, and something is definitely also happening during many puberty in neonatal life. Well, I guess that that's not strictly correct because there are, we're showing evidence for effects on germ cells earlier than the programming window in the rat and we're finding similar effects in the human. They're not in the programming window, but they're affecting germ cells in a similar way. And then, but at the same time, what Kim is finding, talking about, is that you're finding also germ cell effects that occur later in gestation in the rat. So I'm not sure that that would, those two bits of data would allow you to say that we're finding effects earlier than the programming window, as well as later in the neonatal period. I think there are, you know, there are effects on germ cells or whether they're on cell cells or germ cells, we don't really know, but we don't quite know when they are. We don't know if they're more than one mechanism, but they're clearly independent of the stereogenic effects. I think that much is clear. So if you've seen effects neonately on stereogenesis, there's maybe no relationship between those effects and the other ones we're talking about. And I'd just make two comments on that. The effects on the germ cells, you know, through work that Richard's done over the years, the persistence of those effects seems to be transient in many settings. So you just, you know, the germ cells are made to be multi-nucleated, then they dilate apoptosis, then they get replaced by proliferation. And so the persistent consequences of that, those effects on seminephrous cords or totally cells, germ cells, I think are unknown. But they don't have the implications of the concern around the endocrine modulation T levels where you're programming in, let's say, hypospadias or cryptorchizidism, and you can't reverse that once that happens. So there's that question and concern. I guess in terms of the neonatal period, I, you know, there's very little data in that period. There's epidemiologic suggestions, there's the marmoset data, but there's very little information. So I think the certainty of an effect of phthalates in that period is low at this point because of the absence of data. And it hasn't been something that's been modeled, you know, and can be modeled in the well-studied rodent, you know, rodent models that are out there. Is that fair? Question, but just to add, is in humans they're exposed gestationally and neonatally, whereas I think in these models, it's Richard Jersewer either or right. Yeah, we have done routes where we've exposed prenatally and postnatally. And if you only, for some of the effects anyway, not the consequences of suppressing steroid genesis in the programming window, but some of the other effects, such as those on cetone cell proliferation, they get compensated for if exposure stops, but if exposure of the mother continues after birth, then you prevent that compensation to an extent. You can do it to completely. So I think, you know, that it's an important point that really hasn't been sort of considered. There may be there may be effects before and after birth and there is the potential that they could reinforce each other to some extent. And I guess that would be the expected situation in the human, the way you are going to get similar exposure after as well as before. More questions? Well, on behalf of the chat, I would like to extend our thanks to our speakers. Really appreciated you coming here. We've learned a lot and have a safe trip back to your home institutions. And also, thank you on behalf of the CPSC. We appreciate it very much. It's been a pleasure to be here and I wish you all the best of luck in bringing together this really large volume of information and with your report. Good luck. I also wish you the very best of luck. I think we got the easy task. Well, I can only say I hope we don't have to rely on luck, you know. OK. Re-commend the committee, please. And what I'd like to do this afternoon before we break for the day is to set our agenda for the rest of our time on this project and set some dates for our meetings for the rest of the time that we're going to meet. And so I'm going to start at the back. Well, assuming that we submit our final report to CPSC on or about April 30th, Bert and I got together and said, well, then on April 15th, chat members would submit revised draft reports to the chair and the vice chair that we based on an April 5th conference call to discuss reviewers major comments. Remember, we're going to have the outside review. And we would receive those comments on or about March 31st, because we're going to submit a draft report to the outside reviewers on March 1st. We're going to give them four weeks, read the report and submit their review. So that means this is the first of November. We have five months, which to complete our deliberations and write our report. March 1st, four months. Okay. So we don't have a whole lot of time, less than I thought. Okay. So March 1st, we submit our draft report to the outside reviewers. March 15th, I hope we can schedule a meeting in which we would discuss, we had discussion to finalize our report. I say, February 15th, can't read. We would like very much to have a December meeting if we can, at which time we would have a read through of the draft report. And we would also at that time finalize our recommendations for each of the 14 thalates and the six thalate substitutes. Okay. I'll get back to that in a second. Here's what we're, our November meeting, we had our guest speakers. One of the major expectations for this meeting is the progress report for exposure scenarios, which we will be getting into tomorrow. What I want to do after we complete this is to finalize the outline for our report, identify missing section slash topics. And then tomorrow and part of Friday, I'd like to do a read through and critique of all the available report sections that we have and do complete, complete initial run through of the recommendations for each thalate and thalate substitute. I think we, at this meeting, we start, we need to start talking about how we're going to arrive at those recommendations. Don't have a whole lot of time to do that. Make use of the time we have here now going. That's why I think we need to have a December meeting in order to facilitate getting this report done in the time frame that we have left. I'd like to open that up for discussion to see whether what you think and what your time, what your schedules are like for a December meeting. We had a conference call scheduled. Can I just clarify this? I have sort of in my notes a January meeting face to face, but not December. Is this changing? Yes, we talked about, Phil and I talked about that. Phil isn't going to be available for a January meeting. So it would be good, in my opinion, if we can move that back for a week or two and get it late in December. Well, we have another sit down meeting to go as far as we can in getting a document ready for the peer reviewers. Then in February, have the next sit down meeting and be prepared to finalize the document that we have, including the recommendations to go to the reviewers by the middle of February. What we've tried to do is sandwich another meeting in here, and rather than have it in January, have one in late December and one in the middle of early February. Now, the reason for getting this out is if somebody can see a shorter way to get to our goal, we'd be happy to entertain it. We also don't want to end up in the middle of February with nothing to send out to the peer reviewers. And that's what drove this idea of having a meeting in December and another one in February. We thought we needed that to get a draft manuscript ready for March 1st. We had a meeting in January, middle of January. We didn't think that was going to be enough to have a draft manuscript ready in March 1st. In particular, for those of you coming from outside of the U.S., that makes a lot of travel. Yeah. But on the other hand, I think it'll take the same number of meetings, whether we compress it between now and April or if we end up in April having to beg for an extension. I see the intentions and I hear what you're saying, but shall we delay a final decision about that schedule until we face some of the crucial issues today or tomorrow? I think we'll know by Friday morning more to be able to do just that. Yeah. So I agree with you. I think that's I wanted to bring this up because I wanted you to see what we're facing. And I think you're right that that we need to go through the scenario exposure scenario information and data that we have or don't have and factor that into our discussion. And we can do that Friday morning. Yes, exactly. OK, so now I'd like to to go over the outline for our report. I I took what I had as an outline and what I see from Mike, who I think incorporated suggestions that were made at our last meeting. And I wanted to make sure that these were the suggestions that that people agreed upon. And in addition, I want us to talk about other sections that we might want to put in here that aren't yet here. And I and the burn and I both have some some suggestions that we want to talk about. So let's go through the outline as it stands right now. So it starts off with the introduction and background, and that consists of a charge to chap the regulatory history and status of phthalates, chemical properties of phthalates and phthalate substitutes. And Mike, this one is is new. I hadn't seen that before. Would you brief me on what is in there? I and and how does that relate to the section that you've provide some information on before? It could be part of the introduction or it could be a separate section. There's your lease. This is all yeah. Oh, OK. OK. And the C is just a you know, a little bit about phthalates. There are so many commercial ones in generally just general information about the uses, the chemical properties, that sort of thing. It's it's really just background information. So it wouldn't have information on on metabolism that wouldn't go there? Probably not. Like Pekin properties, uses that kind of thing. OK.  There's this many commercial ones and, you know, these are the big ones and these are the ones that chap is looking at. OK. OK. Mike, is this point to broaden after our last discussion about low molecular high molecular weight phthalates? Well, I mean, I could say something about that, but it doesn't have to because that's a. It's an artificial distinction and the definitions kind of vary. So, you know, just some general general information instead of it's in some of the other chapters, but just, you know, they're used in these kinds of products and very, very general stuff. Like you see in the first couple paragraphs of a.  It will be a very boring heterogeneous paragraph spanning from the dimethyl that laid up to right, but very, very general. OK. Just basic information, you know, the structures or molecular weights or whatever point points. But he has a question as we go along, just chime in at any time. So that's that's all we want to have in the introduction and background. Everybody's happy with that. Yeah, and there's a as far as what's in there goes, I think I can add a little bit to section B. The previous reports have things like, you know, the chap met this many times in, you know, stuff like how many meetings they had and that kind of thing. And A. Are we also going to include technical things like cut of date for literature considered, et cetera, et cetera? I mean, it could be in there. It that certainly could be in there. Such strategies. So then we go into the toxicology and burn, as you know, has done the non reproductive and the reproductive toxicity parts looking at these three sections. And you have copies of his most recent draft issues you want to raise with respect to these three sections. Anything else that you think ought to be. Yeah, something that. In some of the sort of writing. Do we need to look back at what Ira says, what other what the EPA has used for. In smart doses or. Reference doses. Are we changing or our tables? You know, the cases we've considered, are they different than what the EPA has used in the past? I don't have a sense of that. And I and if we are, I'm thinking we should probably address why they would be different particular values. I mean, we can easily get those values. I think they're probably different because EPA is in the process of redoing them because they're out of date. And so, you know, certainly we could summarize them. But knowing that, you know, probably within a year of this report being done, EPA will be coming out with new ones anyway. I would assume that that would just be dependent on the literature that they use. Find those. And we've we're using 2011 literature. So right. And there's are probably, you know, well due for. An update. That's what they're doing. The update necessarily go in one direction or another. Or is it just improved data because it's more recent data? Yeah, it's more more recent data. Yeah, definitely. As long as we define, you know, where we're getting our numbers, which we do, I think that's yeah, I mean, the iris databases. You know, every one. Is familiar with that has access to it. So we probably have those numbers written down somewhere. Not hard to get. There's a. Brief section in mind that belongs someplace else and that is that I put some information in here about metabolism and some information about the mode of action. It's not unique to reproductive studies. It is. It's under the larger umbrella of toxicology. And it's in that section in that discussion of species comparisons that we should be talking about. Human versus. Nonhuman primates versus rodents, so on. So even though it's here, it's not. This is not a complete coverage of that. We need to have. We need to figure out where on this report do we want that to be after all of the toxic data after the recommendations we have been front someplace. That's something we can decide as we go through the pieces. Yeah, and as you can see here, I also have a section on mechanisms of action that relate to in utero exposures and mechanisms of action. So. I want to filter it out. Those that related to in utero exposures. So we could very well have a mechanism of action section in multiple areas related specifically to the topic. I don't see any problem with that or we could bring it all out and make it a standalone section. We might as well discuss this while we have it on the table rather than just let it go and forget about it. So what do people think? Because one of the things that came up, Mike had indicated that he had changed my organization and added in here a section on metabolism and one on. Species differences in metabolism and pharmacokinetics and pharmacodynamics. I don't know if there's anything that out there that I'm aware of that relates to. In utero exposures that relate to those. So. But I think there is information out there about that obviously. And that should probably go somewhere else. I'm not sure where. But that's another issue we should discuss. So. Yeah. Can I suggest I mean these things would not mix up with the chapter start deal with effects either reproductive or developmental. I would suggest to pull this out and have a separate chapter called something like toxicokinetics and metabolism of phthalates. Because it's generic. So that could go I don't know if we can scroll back. That could be it could be after C. And metabolism. But when you do you started numbering Roman one or Arabic one and then a B.C.D. Does this imply a B.C.D. belong under introduction. Then it's to then it would be to toxicokinetic and metabolism. You go back again. The exposure section you know where I mean I know we'll come to it but I'm almost thinking that that should be far up front in the report even maybe before the toxicology. One would be introduction background to be tough. Toxicokinetics and metabolism yeah to me basically. Yeah. So the mechanisms of action we didn't deal with. I want to keep that. I have two questions again. It would imply that one to three four five part of an introduction. But this is what but then follows after and then what's in the main part what's left for the main part. OK I'm with you. Yeah OK. OK my other question relates to point number five cumulative exposure. Did you mean really exposures i.e. what Paul is going to work on or do you mean the effect of cumulative exposure. All right then in animals can we call it that then to. Add clarity. So it's. What you mean is experimental evidence of combined effects. Something like that don't you. But there's also a question of how should we handle the human data. For example that I've included in my section on reproduction and Mike you pointed out you questioned whether that should be folded in with other human data as opposed to being there within the heading of the animal data. Yeah. Well I'm trying to recall the exact data. And I mean cross cross referencing is OK. But I think there it was had to do with more like clinical reports or clinical studies or not to mention in vitro studies. Do you put that in the section or. Or do you put it in. Leave it where it is. Would we would we be better off. We can ask this again after we've reviewed my section. But the question will be is it better off left there with the. It's chemical by chemical to leave it there with the corresponding animal studies or move it to the animal to the human. Part where it would be folded in with the epidemiology considerations. Epi studies or their clinical reports some of them because because the difficulty with doing that chemical by chemicals the you know the epi studies are going to look at you know six or eight. So it. You can't really. At least the way I've structured the epi part you can't really do it chemical by chemical because they've measured you know these six or eight metabolites. I did it more by outcome. And these reports are reported mostly by chemical. So they've got hormone levels on a chemical in its metabolites not on phthalates in general or four or five phthalates. Why me that maybe that could be handled by cross referencing to specific sections of your report if it fits. When we go through your section we'll look at. Then I'll look at it this evening you know the specific OK citations and references and what you've written. My section here this introductory section. I need to highlight introduce. Well what we. All this morning I mean. Inter species comparisons. Could go on the three. There yeah yeah OK yep sorry. And I've already I already have the marmoset data. So that do we want to need to discuss and probably this isn't the right time. How we're going to deal with unpublished data. Data is public. No I mean the more in the graph. But speaking about the marmoset data in the neonatal period. I have that in there already. OK. As a developmental stage yeah OK. I think I think some of us should write a narrative of of this what what we heard this morning and in in the introduction right at the beginning under a the charge and chat etc. We should we should also. In the context of literature search and how we dealt with literature come include a. A paragraph there how we dealt with unpublished data if at all that be a viable way forward. You agree with that. Thinking of something else. All right. Tell me again. Make no run. If we would need in the introduction right at the beginning under a where we deal with search strategy literature census date for publications to be that have been considered here we would need a little section on how we deal dealt with unpublished evidence unpublished trying scientific data. And then secondly under C this point number three Thalite syndrome in other species. Some of us would have to write a narrative. Of what we heard. Today but the direction of that narrative would be this is work that's ongoing. It's not reproduced. It's not published. Yeah. And we would we would have to have a. Some some where we would have to reveal how whether or not this is actually. Made an impact on our views or the views which we enunciate. It may come in one of the sections at the end. I think will be appropriate place for that. In some place we need to make it clear that for a lot of these chemicals that we're talking about and it's some 60 chemicals. You know the phthalates and the non phthalates. A lot of them have no data and we need to address how we took that into account and determining risk when there are no data. First of all then it has to be very clear become very clear at some point in the report that actually are no data and then the next step is how we dealt with it. Yeah. Okay. And here's a section. I also deal with the developmental toxicity of phthalate substitutes which I just listed them here. But this section C. I have prenatal phthalate exposures and neuro behavioral effects. So I have summarized the the animal studies on neuro behavioral effects which I think parallels your section on the human studies very nicely so we can go back and forth if we need to and tie those together. That leads us into to Russ's section and what I had before you go and can I just so in in that section maybe in what you've sent us there you know there's text written and then there's some tables. You've sent us tables maybe the two of you guys together. I've sent us a table with some no else listed is that it's such a table going to be part of those chapters. I mean I think it would be nice to have a summary place. I mean for the noel. Yeah. Yes. Yes that could that could easily go in summary table for maybe across the bottom of somewhere that then we could refer to in our chapter as being our case three but it's based on your table. I think it should that be an easy way to reference it. So then we had this section here which will no longer be D but human exposure slash epidemiology I think is what we decided to title it non reproductive reproductive evidence for a phthalate syndrome in humans ontological considerations sensitive windows mechanistic considerations morphological structural evidence. Look about that last time in terms of the phthalate syndrome and TDS that's a religious genesis syndrome I added but you know nowhere near what this would imply you know in terms of based on the human evidence and the relationship between the two because the the epi data is not going to really shed light on mechanistic considerations maybe a little bit on sensitive windows but not to the same extent that animal data does. Okay so how would you how would you want one I was just wondering first off if we would want to have a separate exposure chapter and then a separate epi chapter and if you want epi to I think epi should follow talks then maybe have exposure stand alone chapter after the epi which then would lead into the hazard chapters or that's that's how it is I mean this is after talks right but I I don't know to me it just makes sense to break them into two separate chapters break break one into two epidemiology and the human exposure but they are here's human exposure down here pathway analysis that would yeah I guess I would just call D epidemiology and E human exposure pathway analysis. As the will not have the human exposure can I also suggest to what what begins to where I get lost is we have now three we have Roman numbers then we have ABCs yeah we'll sort that out okay that that'll can I then within the existing framework of can I suggest that D human epidemiology Bracket of Mauser brackets closed becomes Roman for we pull it out at the moment it would suggest it's part of the Roman three toxicology chapter would you agree with that yeah that that yeah I didn't mean it to be part of toxicology it's not he would be five yeah that's you know that's the way it's intended to be so do you do you not want exposure to be in yours is that what you just want to be out epidemiology epidemiology because last meeting we argued for this but you don't want it that way right well because it's not going to include exposure data I mean it will as part of the epi study but not in the same sense that the way Paul's described okay I'm happy and would you want me to you can just put epi because all that these humans yeah the way I structured it now I started off with the reproductive first just because that's the primary focus but that's easy to move around what we can think about that whether you know it makes sense to start with our and so to would be and of the non reproductive which primarily would be the the neuro should we make it neural yeah we can we can use the I mean is it anything else structured I can't remember and then the tables I've embedded but they can definitely be pulled out so the first section was well after a short intro was reproductive track and genital development so reproductive yeah and then the next was the neuro developmental outcomes main section and actually this I should probably move this was reproductive hormones in infants you know the main and the study which I would move into the repro and then there's some studies on pubertal development and gynecomastia which could come under reproductive and so development and reproductive structure those and then and then there was the adult exposures the semen quality studies which you know basically we're mostly just referenced and not described in detail but I think that would also be the repro and developmental section okay would within the reproductive developmental section there could be a you know general tract development there yeah carve that up yeah there could be subsections yeah so I'd say yes there'd be just two repro development and three you want to just do away with I think so because it's in there but it's it's discussed in the reproductive section yeah towards the end in terms of making a conclusion and references the talk section phthalate syndrome and rats see talk section and we thought of as a sub phenotype of TDS which we can discuss tomorrow so there's Paul's section and we just have two sections that phthalates and phthalates substitutes limited to children's products and I guess this would be the Paul's section because I was just wondering if there was more before you flip the slide but so here he's going to try to put in perspective human exposures childhood and pregnancy or is that something in your section Chris we're doing we've we've reorganized to include a bio monitoring exposure section but this could be the modeling exposure section and my question is is it going to be pages and pages of tables or is he going to have text well we know yet there's there's going to be some text I don't know how much text versus it may be more tables in the text I don't know but we're trying to mimic what you're doing so we're doing various populations the first is women of reproductive age then infants and then I think older children and then I don't know general population but we'll see how it works out if that's even much different from adult women and adult adults in general you know we'll see but that plan right now is to have those four groups and the set of allates is probably includes the same ones that you see in the bio monitoring there may be an extra one or something I don't know because oh yeah I think it includes diethyl just because they're well there's a lot of data on diethyl but the I mean structure-wise I'm not sure if we could do the same I mean looking at I mean we're looking basically looking Thallite by Thallite looking at the cumulative exposure in the way you do I don't think that's going to be practical I mean because we're not looking at people and saying you know you know how one person may be exposed mostly to the EHP and another one a little bit of everything I mean I don't know that we're going to be able to get down to that level the biomonitoring section embedded in your chapter could be taken out and we pulled it to the front focus mainly on the exposure and we have a table now that has the biomonitoring sort of point estimates of using population weights diesters and then we had included a table I mean I just took some subsets of some of the one of the Excel spreadsheets you guys sent but it didn't seem complete yet so I'm not sure I chose the right model or the right whatever we're still working we're still working on it so I think the idea was by the time it got to our chapter was to have some sort of comparisons about you know here's if you do a biomonitoring approach these are sort of the estimates that we would get for like the median or the 95th or whatever and and then if you compare that to what they did you know what are those numbers what is the swan data look like compared to the NHANES what are you know and you would make that comparison in your chapter because yours follows Paul's so that's what we were thinking is because then we kind of draws together the whole exposure you know are the exposure values that we're using through our modeling similar to other approaches of getting estimates or ask the other way or the other approaches similar to the biomonitoring yes yeah well I mean it's first are they roughly similar and second I mean if they are roughly similar then can you say anything about what are the relative contributions from different exposure pathways or whatever which may actually suggest some of the exposure sort of writing be even after our chapter yeah I mean I think it could be done done either way yeah I mean that's that's kind of what I was thinking getting at but it seems like the biomonitoring and the rest of your chapter need to be together you can't kind of biomonitoring and then have Paul's piece and then your that that wouldn't work and then to put Paul's at the end after it's a nice comparison to see point estimates you know relative to and Haines population and then the swan data what are those other approaches are they in the ballpark I think we could introduce comparison paragraph after the daily intakes we calculate based on biomonitoring data with comparing it from the external exposure estimates and then we could go on to the hazard index segment of our work so that would fit so that that's the way we intended it that we do the biomonitoring exposure estimates as a first part in our paragraph then switch to the hazard index calculations and in between we could discuss different roots relevance saying we can actually make ours into a couple of chapters in the end it will probably profit from it if we separate it slice it up what would be six apparently we agreed on a section called mixture effects slash experimental evidence Andreas was going to write that I have written it but did we not did we not discuss last time to put it to put it into the section of developmental talks and the toxicology notes notes that we may have I don't remember we could yeah under this section C in the introduction one so you want you'd want to put that really around where the Earl Gray's data are is that what you're thinking yes and at the end of your and some of our own yeah that's a cumulative exposure yes exactly the fine make it make it section six no make it that's what's going to go under section five yeah well we have to rethink think carefully about this because there's also which I haven't written yet but which will come some considerations relevant to broader issues of risk assessment which also will impact on what organ Chris are doing this I'm going to write as well and but they sit well there I don't know that may be a nice introduction so if we break our chapter up into an exposure part that could go with Paul section and then you could write a little introduction about hazard index risk assessment whatever and then go into our hazard index approach my thinking at last time was you know to support your hazard index considerations you can only support this if there's experimental evidence that indeed those and it's work together according to those addition so this evidence I will provide for this point number five and then you know you can then refer to it or take it forward you get my drift yeah so I've added add section from Andreas yeah okay I haven't written a whole lot there so that can either be taken out or can be integrated I'll do that okay back down here so then seven selection of toxicity end points and sensitive life stages basis for prediction of human risk not sure what's going to go in there but I've apparently agreed to write it we can make this section number six disappear yes that's right that's right are absolutely right and it's really easy to do on a computer and these numbers will change but then assessment of exposures to thalates and then this is going to be your section older and this is what I came away with from what Mike supplied me chemical biochemical assessment cumulative assessment hazard index approach method application assumptions I think that's all I had oh now then there's results of hazard index evaluation should be up on the previous slide so I think what one thing that we're doing that's different than what's come before is to focus on the biomonitoring data the risk assessment of exposure to thalates but the approach that we're using is based on biomonitoring estimates of exposure that's where we were trying to set the stage for how similar the comparison is between the approach of using biomonitoring data with the exposure you know modeling so how would you like to change this well I think I don't know maybe I'm so used to thinking about mixtures it's hard for me to go back and think of it on a chemical biochemical basis because the biomonitoring suggests that they don't you know it's clear it's not just one chemical at a time but in your analysis you did do it chemical by chemical right first not really I mean we've got we've got estimates of hazard quotients that would be like a chemical at a time yeah but it's not done it's it's a part of the overall approach not a standalone a standalone do you want to eliminate that because you don't make conclusions chemical by chemical and it's it's part of your I mean I mean yeah the way we've been thinking about I think is just on a as a cumulative set not as a individual has it so clear that they're together from the biomonitoring data well you you said you separated out the biomonitoring the exposure part of it exposure part is that also cumulative or is that chemical by chemical well I mean there's a table now that has it you know one chemical at a time comparing the different point estimates but it's all in one table it's not you know well but it is chemical by chemical yeah I mean each chemical is in is across the the top of the column labels or the chemicals and then we have you know median effects and 99th percentile estimates from the in Haynes from the swan data and then comparing to the Wormarth or whatever exposure modeling and then to what Cortencamp and Faust used in their paper I don't know if you consider that really chemical by chemical is just all in one table well I think that's that's all it's all the basic information you need here so but in terms of organization I think we're trying to make this day make make the exposure sort of seem relevant based on different approaches you know incomparable and then go into the the cumulative assessment using the hazard index approach I think now that we've gone through most of this what each of us needs to do we now written a good bit of our sections know what our sub headings are I think translate that into something I can use for an outline just to help me organize this and make sure that we haven't left any holes that that's all I'm using this for I think our part is less complicated than it might look like so first as we already said we we try to do exposure estimation based on bio monitoring data this is not a risk assessment per se in the beginning so we just try to do exposure assessment by human bio monitoring and that is chemical by chemical you can that we have individual data for each of the late then we agree to introduce a paragraph on comparing external exposure estimates with by a monitoring approach exposure estimates and then the next step would be to switch over to the cumulative hazard index approach that's that's not too different no you have here but it would mean that somewhere between six and eight we would insert something like closure assessment based on human bio monitoring so we don't start with risk assessment we start with exposure assessment want to have a section seven that would be something else exposure what I called it here was estimating exposure from by a monitoring data and pregnant women and infants by the assessing estimating exposure from by a monitoring data and this paragraph would include a comparison with the external exposure estimates but this would be something like a seven B and that would be a common paragraph you all right so that's you Paul me whoever wants to take part but it's like an evaluation of the different approaches if there's some commonality there it kind of qualitative valuation miss something in one of the other approach other results consistent but I think the important part of this is the bio monitoring is going to have to be all of the chemicals to gather from all exposure routes right exposure modeling is going to be able to attribute certain exposures I guess a certain percentage of exposures to different types of yeah I mean that's probably the easiest way to I mean this gets to the I think the point of what we're trying to do in terms of the chap I mean our mission are we really just focusing on toys and personal care products and in the sense of a real risk assessment going to be difficult to separate that agency by agency we need to do it according to real human exposure I would think it's the most important thing to do so is that a concluding thing that we say at the end you know go back to our mission or I think it depends on how yeah I mean you look at the the chap's mandate I mean you you're looking at cumulative risks and that's part of the mandate but in the end the decision that the commission has to make is on a net is essentially children's well toys and child care articles is the ultimate decision the commission has to make so sure the total exposure the cumulative risks from all the sources is an appropriate measure of the effects on human health well aren't making a comment on personal care products for for pregnant women or for women well the exposures are coming I mean the chap has to include exposure from all sources and that's certainly part of the assessment includes personal care products I guess my question is our products under your jurisdiction or products under well personal care products what I call cosmetics are not under our jurisdiction that doesn't mean I mean I I think you're supposed to look at the overall risk and including all sources and say whatever you want in the end the commission has a narrow a narrower jurisdiction but that's sort of for the I guess that's more for the commission to worry about you know it's like first you define the problem and then how do you approach it well the commission could only regulate certain products I mean it goes beyond the children's products but it's does not include cosmetics so you know I think you're you're assessing total exposure and total risk but I think for the risk managers down the road the commissioners it's useful to know where that exposure is coming from you know who's just which products and whose jurisdiction are they is that sort of taking the exposure modeling data at the end maybe in a discussion of what we're going to say at the end but yeah okay yeah this comes a certain our best guess is a certain percentage comes from yeah products or this dude or this whatever yeah not to divert too much but so so section seven then will essentially just be at this point overall comparison not based on percentages of I mean the the route of exposure look right because I think we got a table from from Mike you and Paul that sort of summarized it together yeah all the exposure routes or whatever you guys were modeling yet that's a total what I sent was total well if it's buried in those spreadsheets is everything but the summary I sent was just total exposure couple of things one is I think of what this report might look like I'm getting a vision of a report that might be two to three hundred pages long and it's only in section 14 only one or two pages of that are the recommendations that seems overbalanced out of balance that people would look through this outline because there will be a lot of people who will only read the recommendations and we're going to make them plow through 200 pages of technical materials before they get to the recommendations as opposed to having a report that section one is the introduction in charge section two is background and methods materials kind of stuff and section three is the report is the recommendations in section four is the references and so on but it makes it that would give a message that we focused our attention a lot on the recommendations as opposed to 200 pages of background material and all of a sudden it fell into place here's one page of recommendations I'm not sure I like the way that sounds now it may look different from that or the solution that occurs to me is that are there sections of this that are highly technical information that should go in a series of appendices to shorten all of that stuff before we come to the guts of it which is the recommendations and if people want to go through to find out how much of which the allied is in their favorite hand cream they can go to an appendix to get that not have that way up front as something that they will wonder when am I getting to the substance of this that is in the important part of getting this group of experts together as opposed to pulling together other available information that didn't require scrutiny of the experts except to decide where to put it that's one thing that we might might think about and Mike I'm even ashamed to ask this question but better late than never to have asked it who is the audience for this report but this be written for CPSC should it be written for the general public should it be written for people who are engaged in phthalates as a livelihood industry scientists so on we write it at an eighth grade reading level which is as much as it should be if the general public is going to read it they're going to stumble over eighth grade reading level well our approach has been the body of the report is written as as a scientific publication now when you get into the recommendations or and especially the the executive summary we tend to make it for a more general audience the audience in this case the the narrow audience is the is the commission we're not scientists but who have to make a regulatory decision so but the I mean the technical pick parts of the report definitely should be written as a any other scientific publication now the idea of putting things in the appendix is you know certainly that can be done in the I'm thinking that the exposure scenarios part will be especially amenable to that otherwise it may end up way too big but I think you know the the chapters and so on as I've read I mean it's not just presenting information I mean there's a lot of analysis in there so you know I think it's going to be a good report but I mean you're right so well some people will only read the executive summary anyway but that's we have no control over that for example my chapter on the human and animal reproductive talks what's up front could be just the summary of the no ales that gives these studies that we considered and at least the no ale and the endpoint that was affected but the description of the study by study could be an appendix I don't know if that's too sparse in the front or not yeah I mean it's I guess it's well it's up to the chat but it's I guess it's a matter of finding the right balance of giving enough detail so people could follow the reasonings and why you got to your conclusions I would totally agree with Bernie's ideas the what we've detailed now in terms of structure could easily be an appendix and we could write a much shorter report which in fact would be the core consist of the core of recommendations and the function of that more detailed material would be then to be able to refer to relevant sections in the annex supporting recommendations so we you know what I visualize is something like a maybe 35 page document which but crucially contain things like you know considerations philosophy la da da on which we base our recommendations I mean this we haven't yet covered but that that's key and I actually think that what you're getting at on Andre Sanburn both I mean I think the one of the most important things we're going to do is to figure out what it what our recommendations are and what it's based on I mean we've got exposures that are going to change with time and you know a lot of very difficult things to work with I think the important part is how we dealt with those things and some of the port of that could be elsewhere but the in I mean I'm thinking in terms of not just all this information and then conclusions but probably a discussion section where you talk about all those things exactly how you interpret the information and get from point A to point B would it be more digestible if it was like Andre is saying a 30 page like a like a paper in itself here sounds these are the just these are the difficult things we had to think about how we chose to do that the supporting evidence sounds okay to me you know my section on developmental talks where I've gone through I don't know how many developmental talk studies and summarize them you know when when they were exposed to what the doses were I mean that for some of the way through that I mean it would just it would yeah put people to sleep put me to sleep well I find it thrilling it doesn't put me asleep at all well so I'm wondering how long is the bibliography going to be I mean that may be the biggest part of the report I appreciate the discussion of this not that we need to make a decision now I think this could also be revisited after we've gone through the four sections that we have and see if it makes sense to talk about it more or drop it but it might be a very novel thing about what we're going to do is to figure out how we're going to make those decisions and just even outlining that 30 page paper of this is how we did that I think would be really very very important well I think a 30 some page overview of the strategy that we considered and how we approached this would make this more useful to people who do this in the future whether it's the highlights or not but a lot of these reports go on the shelf forever I mean somebody takes it off their desk and puts it on the shelf I've got a lot of those that I've never read just because when would I find the time to read a 300 page report when I might have read a 30 page one I'm just going to say as a reader of reports to have something you know if there's too much detail you don't see the big picture and yeah I kind of like the idea of having a shorter paper with backup sections so you can see the forest and the trees and these are other these I think are the crux of what will be document we are talking about now the impact of variabilities and uncertainties our discussions conclusions and recommendations executive summary that's going to be the heart of what we're going to be putting together we have an executive summary at the front end the back end oh I think we may hopefully we can get by with just one yeah well I think I think it should be up front so I'll delete the one at the back who had some topics that you wanted to talk about burn well I think we have folded those in have we I had made a list of what I had made a list of things we need to find authors for one of them is this broader section on mechanisms and mode of action and I think that would be up front in the 35 pages of the report metabolism as it relates to toxicity and as it as it defines species differences in sensitivity then dealing with the broader issue of the absence of data and how how we determine risk what did what assumptions did we make about risk when there are no data a lot of these chemicals are in that category I think what we need now is another another outline for this 30 page paper I think you and I need to bump heads come up with a draft that we can put before the committee what about something along the lines of just a shorter version of I mean it would be very interesting to start with even just the of that of that situation that there these all of these chemicals they're in some products and but we have some in some talks information about some of them but many of them we don't and so what do you do with the things there's exposure we don't have any talks data just because we don't have any data doesn't say they're safe so what do we do about that I mean that is a very important question but I don't think we should just kick down the road well I think it's important that there should be up front it should perhaps be a statement in the executive summary it should be in the introduction and charge and it could be one of our recommendations and not all of our recommendations have to be either to ban or to to restrict there could be recommendations for other things as well and that could be one of them Mike were you you put together this introduction before that we've seen and I still think that's this standing introduction to this document that the 35 page one yeah well it's the yeah I think it's supposed to be part where is it in which tab but it's it needs to be expanded a little bit but that's a yeah it's it's it's it's supposed to be in tab five well but it isn't well I it's not in mind but well that's for the I put that I think I just get to tab but it's it needs to be expanded a little bit but these other things certainly can be added yeah Mike another semantics question and I know I've talked with you a little bit about this before maybe it was the whole group but it's the distinction between banning and restricting yeah and the interim ban what does that really mean well you know it's it's one of those the statute uses the term interim ban in but in for us CPSC a ban means a mandatory regulation so that's something that doesn't meet the requirements is banned you know it doesn't mean you ban the chemical entirely or a product entirely it just you know it says if you don't if you don't pass the test whatever it is then you're banned so I could try to get with the lawyers and come up with the you know worry about the wording of these that kind of thing if you want to try to put it in plain language for the time being and I'll get together I'll get the the right verbiage to use for that I agree with the suggestion that under us made earlier today that at this meeting we should have some time where we would talk about what does ban mean what does interim ban mean and what does no action mean I assume those are the three things that we can do and for silent that means no action but we were going to have to either come up in order to meet our charge we're either have to we either have to say that the ban should be continued or the interim ban should be expanded to a ban or released from that ban category so I think in order to have that discussion of what are the criteria that we're going to use for making that distinction when we get the hazard index information we get the rest of the exposure information in front of us and then we have to go through these chemicals one by one and make a statement about each one and we need to know what the distinction is between a ban and an interim ban or if we could not use that term at all and talk about because it would seem to me we we may recommend that it not be banned but there would be no more than a tenth percent in these children's products by way something right and well that's what the ban really is you can't have more than 0.1 percent and I call I try to use the word prohibition okay so a ban isn't a ban either right when he talks about a ban doesn't that mean that you shall stop distribution right right that's not what it means here well it well it it's a condition you know it's a conditional if you don't meet certain requirements in your band it sounds scarier than it really is when we talk about criteria I think we need to finish this discussion yeah any other questions or comments like do you have any thing you want to discuss before we adjourn well let me just give you a brief update on what we've been doing we have as far as the the final lit search that is I'm actually finishing it up right now I hope to have that before we all leave on Friday and we finalize some documents you you've seen drafts of the you know the last 10 talks reviews from verse are in the little piece on possible natural sources of phthalates those have all been finalized so what I want to do is get this last literature search in these documents and I was able to get some of the publications in the literature search not all of them but whatever we have on a CD so you can all take it with you when you leave no first first hour is going to be here after lunch or by one o'clock so can I can I be a little provocative and suggest a change in agenda that we put as first item on the agenda a brief discussion or a brainstorming about our recommendations for example I mean the risk assessment of mixtures what what I will have to say I can say in a nano second I forgot you missed it you missed it I saw it I'm hypersensitive to my name really it's terrible brilliant recommendations we probably want to hear from Holger and Chris I think that's where I was going to be my comment and then talk about recommendations yeah I'm happy with that yeah so conclude you better make sure you have a strong impact on our recommendations although I am reluctant that our approach should be the sole point for the recommendations we have for this morning oh that was to me we that okay okay we did what we did today that not hearing any comments or questions we'll adjourn and meet again at 9 a.m. tomorrow


More than 30 free F-16s have appeared in the EU, which can be transferred to Ukraine. For example, Greece, which is currently implementing a large-scale program to modernize its Air Force fleet may transfer to Ukraine. As part of the modernization program, it is planned to decommission 108 fighters and prepare them for sale, including 32 F-16C slash D-Block 30 fighters according to Greek media, the transfer of 32 F-16C slash D-Block 30 to Ukraine is considered almost inevitable. It is noted that during their service, fighters of this type have undergone two modernizations and today, on average, they have used up about 60% of their service life.So, Greece is undertaking a substantial transformation of its Air Force, planning to decommission and sell parts of its diverse fleet, including F-16 and Mirage 2000 fighter jets, as part of its efforts to modernize and streamline military capabilities for the 21st century. According to the Warzone, the Block 30 F-16s include 34 single-seat F-16C and 6 F-16D variants. Those aircraft were procured under the Peace Xenia I foreign military sales program and delivered between 1988 and 1990. It was previously suggested those aircraft could be used as aggressors for air defense training, but it now seems more likely that Athens will seek a foreign buyer. The aircraft might not have to fly far, Ukraine was quickly named as a potential destination. F-16 no silver bullet for Ukraine against Russia NATO Secretary General Jens Stoltenberg F-16 fighter jets would not serve as a silver bullet for the Ukrainian armed forces amidst the ongoing conflict with Russia cautioned NATO Secretary General Jens Stoltenberg. The swift delivery of these fighter jets to Ukraine would serve as an example of significant military support for Ukraine from NATO Stoltenberg said NATO allies providing Ukraine with F-16 fighters sending weapons for those planes and training pilots is a very important example of the alliance's military assistance to Ukraine he said. However no single system can change the situation on the battlefield alone F-16s are not a silver bullet that will determine the course of the war F-16s are important for Ukraine as they will increase its capabilities on the battlefield Stoltenberg said he expressed appreciation for Ukraine's allies dedicated efforts in facilitating these deliveries and providing training for pilots and technical personnel involved with the F-16s UK Prime Minister Rishi Sunak announced that his country along with the United States the Netherlands Belgium and Denmark had agreed to participate in training Ukrainian pilots on Western fighter jets on May the 19th 2023 Romanian officials said on July the 6th 2023 they were opening a regional training center for F-16 fighter pilots which would be available to its allies and partners including Ukraine according to media reports the first F-16s will appear in Ukrainian skies around June 2024 the Belgian government recently approved the allocation of its 25th aid package for Ukraine which includes funding for the maintenance of F-16 fighter jets Denmark and the Netherlands were the first countries to pledge to send F-16 fighter jets to Ukraine but said this would happen after the Ukrainian pilots had completed their training vote on aid to Ukraine in US Congress may be postponed for several weeks the house of representatives vote on aid to Ukraine is unlikely to happen until at least mid-April and possibly later as Speaker Mike Johnson is still seeking ways to soften opposition from radical Republicans Bloomberg reported this citing the leader of the Republican Party in the house of representatives they say that Johnson's team has not shared a detailed plan regarding the aid package with Republican lawmakers and it seems undecided on the actions he will insist on from President Joe Biden's administration making it difficult for him to secure support in time for a vote next week Johnson spokeswoman Taylor Halsey stated that the speaker's promise of swift action did not intend to establish a specific deadline and that Johnson was sounding out members regarding the plan she did not provide further information on the speaker's consultations two representatives of the Republican leadership stated that there is still a possibility that Johnson could decide regarding the Ukraine aid plan over the weekend and expedite the project's approval next week however Bloomberg notes that such an accelerated schedule could lead to the bill's failure and further confrontation with hard-line supporters within the Republican Party recently the administration of the US president refused to accede to the proposal of the Speaker of the House of Representatives Mike Johnson to provide aid to Ukraine if the president reverses his decision to suspend the issuance of new licenses for liquefied natural gas exports the US Congress's approval of over 60 billion US dollars in aid to Ukraine is currently being blocked by Republicans in the House of Representatives the White House has repeatedly cautioned that this would significantly harm Ukraine's military efforts on the battlefield


This is Business in Hawaii, my name is Ray Tsuchiyama, subbing for Reg Baker, who is unfortunately or fortunately on a neighbor island doing business as usual and running his own firm very successfully. And now we are going to be delving into many topics with my guest, Adrian K. Hong. And he's the president of Island Plastic Bags Inc., located in lovely IAEA Honolulu, Hawaii. And before we go into it, I just want to say that small businesses really drive the economy in Hawaii, and we have a landscape of people leading a lot of firms in manufacturing, which is challenging to do. The whole world of manufacturing deal with product lines, in sourcing parts, and also dealing with people and machines. And it's really great to have a person here in a family-run business that I'm going to be really discussing the present and future of small firm manufacturing in Hawaii. And welcome to the show, Adrian Hong. Thank you so much for having me. I really appreciate it. Now, tell me about Island Plastic Bags, the firm. How did it start? Where was the idea for the firm and what was the product? Okay, so the idea from the firm came from my father, David Hong, was working for this company called Pacific Plastics at the time. And he realized he could do it better. He could do it better. He could run it better. And then he talked to my mother, and my mom's like, go for it. You shouldn't be working for these people. You should be running your own company. You should be doing this. She was the one that really pushed him to do that, and it gave him the bravery to go and take that next step. And what year was this around? It was around 1992. Okay. And so we would call him your father back then, or your parents were entrepreneurs. Yeah, definitely. They were entrepreneurs. Initially they wanted to buy Pacific Plastics out, but the deal fell through. He didn't sign the agreement, so we started our own business, Island Plastic Bags, and we competed against him for a while until it came to the point where my father sat down with Stephen Lau from Pacific Plastics and said, you know, we're competing against each other. We're getting to the point where none of us is going to make any money. We're both going to go to our business. The difference between me and you is I have an SBA loan that's coming through, and I'll have another $250,000 to put into this. And so Stephen Lau decided to sell his business to Island Plastic Bags, and we were able to go from there. So from this, you know, concentration or new entity, what was your product from the beginning and has it changed to now, 2017, and your customers, have they changed at all or have they remained the same? So our core product line is institutional trash liners for nursing homes, hospitals, hotels, restaurants, bars. A variety of products that we produce over time has changed. We offer clear food grade bags, we offer trash liners. We offer t-shirt bags now, which are checkout bags. You don't see them in grocery stores anymore, but you do see them at restaurants and other bakeries and stuff like that. So our product lines have increased. Our core of our business is still trash liners. We also are a Colgate redistributor. So we sell Colgate Pomala products that are institutional, like five-gallon drums of Pomala, not like the ten-ounce bottles that you'll find at stores and stuff like that. The supersize. Supersize. A restaurant needs five gallons. They don't need a ten-ounce bottle of... So I take it that your world of customers are B to B. You sell to firms, not to end consumers. Am I correct? Yeah, that's correct. We sell to businesses. Right. Your product line that you manufacture in Hawaii, what is the percentage that you manufacture here and what's the percentage you import for special clients or customers? It's about 50-50. Okay.  So 17 people. 17. Yeah. So you're really a small family business. Yep, small, locally owned family business. And how long have you been president? So I've been president since 2015, so it was a pretty recent thing. I originally, my background is certified public accountant. I'm no longer in public practice, but I got my undergraduate and master's degree at University of Washington, worked up in Washington for a while as a CPA, worked in the financial accounting standards board, which makes accounting standards for the United States for two years in Connecticut. And then realized that working 75-80 hours a week wasn't really doing it for me. In terms of work-life balance, I was eating three meals a day at my desk. So I started to talk to the family back in 2012 about coming home and taking over the family business. So we discussed it. They were happy because they were deciding at that time whether or not, what their succession plan was going to be. A lot of small businesses, they hit that point where it's like, okay, the president, the owners are getting to a certain age and they need to start figuring out what they're going to do going forward. So they were happy to bring me in. So I came in as a general manager, and I had a background in financial statements, but not a background in sales or human resources. I mean, in a small business, you wear a lot of hats. So it was a really good opportunity for me to come in, not as president, but as a general manager, learn the ropes, gain people's respect both inside the company and outside the company with our vendors, with our customers, and all that kind of stuff. And then I took over in 2015. Now, looking back, and of course, in the beginning, you were with your father going out and meeting customers, and of course, being on the line and kind of figuring out problems and so forth, what was the most big concept or idea that you learned from your parents running this manufacturing organization? And from your numbers background, you said, aha, wow, I didn't know this about running, leading a small business. So the biggest thing that I got was, sales is hard. I never realized how hard sales was, because I was a numbers guy. I was working in the office on numbers, not actually going on selling things. But you make 10 sales calls, and you're lucky if you get the one or two calls back, and you get that sale. So it was an eye-opener to see how much work went into building a customer, going from a potential lead to a customer. And then it made me really realize and value our current customers. Instead of figuring out how I could get new customers, it's like, how can I serve my current customers better? How can I cross-sell to them new products and stuff like that? So it really changed my ideas about how I was going to approach growth in the company. And it really made me value the personal connections you have with your customers, because that's so important in that part of the sales. So this is all about relationship sales. Even for a small company, when you have customers and their needs, did you feel that you had to listen more or just focus on their problems? What did you focus on after a while with talking with your customers? So I always try and find out the pain points. What's not working is the bags falling inside it. When you put traction, does it sink inside?  What's the pain point? Is it ripping? So once I figured out what the problem was, what they're using the bags for, then I can create a custom specification that meets their needs. And the great thing about being a manufacturer is you can customize the different products that you're offering. And once I create a custom specification for a customer, they're likely to stay with me, because I created something that specifically meets their needs versus a company from China or Malaysia or the West Coast. You're buying one of their four options that they have available here. They're not making a direct sales call to you to figure out what you exactly need. Jack Welch, when he was President and CEO of GE, he used to say 90% of my problems are people. He had to get the best people to run his organization and so forth. Even for a small company of 17 people, do you have issues in hiring, mentoring, training, and drawing the best out of your employees? So we definitely had a problem with, we were looking for a plant manager to help upgrade our equipment because we're reaching that point that we're going to have to invest another million or $2 million worth of into new equipment to increase our production capacity. We're getting near our production capacity at our current facility. So we had to go look outside of Hawaii because the manufacturing base is so small here that there wasn't a lot of a very big talent pool in evaluating new equipment, creating transition plans, creating capital budgets, and stuff like that. So we were very happy that we found Leonard Levy from Orlando, Florida to come out. Well, way out there. Way out there. It took a while. It was a search. How long of a search did you do? I would say it was six months to a year. Wow. And then we also enlisted, eventually enlisted executive recruiter to kind of help us do that. That's a really expensive proposition when you're a small company trying to do your business at the same time. It was an expensive proposition and it was costly, but you have to make that investment into the future. We need to start putting in new production capacity.  So you have to take that leap of faith. It's like my father and my mother did 25 years ago. You have to take that faith and say, okay, this cost is expensive up front. This equipment is expensive. We're going to spend another million, $2 million. But in the future, it'll pay off. We'll be able to grow our business. We'll be able to be more profitable, more efficient, all that. Well, manufacturing we discussed before used to be much more prevalent in Hawaii. We used to make things that we use daily or in our lives or B2B machinery and so forth in Hawaii. And of course you realize, and you may be young for this, but one of the major areas for manufacturing was pineapple cannery, and that left or that disappeared with the end of the cannery in Iwile, the end of the cannery in Maui, and also I think there was a cannery in Molokai many, many years ago. So that was one area where people learned how to make things, manufacture. And that was a lost art in many ways. And so the smaller companies have to really develop their own expertise in manufacturing. They can't rely on hiring from other firms because there aren't many firms left doing manufacturing in the cock-occles, the Iwile's or Mapuna Punas because they've been converted to housing or commercial space, and there's been a huge transformation in the manufacturing landscape in Hawaii. Definitely. So yeah, I mean we do have to build a lot of our internal, you know, we have to build up our staff, build up our training and stuff like that because you don't have as many resources as you would. Like if I was a manufacturer in Ohio, there's so many other plastic bag manufacturers that you can pull from and certain resources and stuff like that. So in Hawaii it's definitely a challenge. And we'll come back to delve more into the space after this minute. Thank you very much. Aloha, I'm Tim Apocha, host for Moving Hawaii Forward, a show dedicated to transportation issues and traffic. We identify those areas where we do have problems in the state, but also the show is dedicated to trying to find solutions, not just detail our problems. So join me every other Tuesday on Moving Hawaii Forward. I'm Tim Apocha. Thank you. I'm a licensed marriage and family therapist and I'm the host of Shrink Wrap Hawaii where I talk to other shrinks. Did you ever want to get your head shrunk? Well, this is the best place to come to pick one. I've been doing this. We must have 60 shows with a whole bunch of shrinks that you can look at. I'm here on Tuesdays at three o'clock every other Tuesday. I hope you are, too. Aloha. We are back with business in Hawaii. And I'm subbing for Reg Baker, who is our great mentor out there, promoting small business and trying to raise the level of talking about issues, challenges, facing the leadership of small businesses in Hawaii. Because if we do better, I think the whole economy does better because small business really drives growth and creating new jobs for a lot of people throughout the state. And I'm with Adrian K. Hong. He's the president of Island Plastic Bags Inc. Located in beautiful IAEA. And we are going to be talking about his other background being a CPA and whether that brought a different set of eyes to his family run business, or it really created a kind of a really drive in putting together and to his total background of numbers and really on the grounds running a company. Tell me how being a CPA was a value add when you joined the firm. So it was a great value add. It's a great basis to have. So when I came into the company, I looked at the financial statements. I could tell that we were healthy. Our cash flow was healthy. Our profitability was healthy, which is a great start. Like when you come into a family business, you don't want to go, oh my god. So it was a great position to start from. But having that experience and then going when I was in public accounting, I did audits of private companies. Going out to private companies and seeing what worked, what didn't work, what I wanted to see in financial statements is what I didn't want to see. It was a really great basis to start from. So I could look at financial statements. I could look at our monthly reports. And I started doing those monthly financial statements when I came to the company. Looking at those and saying, we're doing well. This month wasn't as good as this month. It really created a, I could see the results of what we were doing. So that was a great foundation to build on. It wasn't everything. Like I said, I completely didn't. I had to learn about sales. I had to learn about human resources. Still learning about like doing, how to make an effective performance evaluation, how you motivate your managers, your employees, and stuff. Like that's still a learning process. Now you've been involved with the young CPAs, the group subset of the Hawaii State CPA Association. Am I correct? Yes. Now one of the things that you bring to the group must be your work being a CEO of a small company. I mean, kind of a transformational kind of vision of what could be better for firms and how CPAs can work with company leaders and so forth. Am I correct? So that's what I like about the young CPAs. They're such a great, talented group of people that we all bring a lot of leadership and new ideas to the table. And they're a really great group of people. We do a lot of community service projects like beach cleanups. We go to the food bank and help package food for seniors. We do also a lot of educational events because the HS CPA likes the young CPAs to go out to colleges, high schools, talk to the high schools about our career in accounting, talk to colleges about passing the CPA exam, about resumes, how to write a resume. I really like those workshops where you can kind of help students, because a lot of them have a really great work experience, but show how to better demonstrate and display their talents and stuff like that, what they should be putting there, what they shouldn't be putting there, doing interview workshops so they can kind of iron it out. I don't, yeah, I can remember myself being incredibly nervous at my first interview. I don't know how well I did at my first interview. When I was still in college, trying to get a job for the first time, but having those mock interviews definitely helped. It's really nice to be able to do that. But most CPAs after getting a license work for independent CPA firms, am I correct? Most CPAs, some work at the large companies as a CFO kind of thing, and others go off on another track like yourself and run companies or be part of small companies. Yeah, so most certified public accounts go out and work for public accounting firms and stuff like that, doing audit, tax work. So-called big three, big five, right? These big four now, yeah. Arthur Anderson kind of disappeared, but yeah, it's the big four now. But they work for those firms doing audit, tax, forensic accounting, a lot more now in where IT meets accounting. Because you've got cyber risks now, you've got these huge accounting information systems that are collecting data all over the United States and all over the world. So you have a lot of people in that area now, too. So there's a lot of consulting work in addition to the auditing and tax now. And then you do have some people go work for the bigger companies and their accounting departments. And then you have some people like me who go into smaller businesses and more in the executive areas and stuff like that in business and industry. So yeah, the YCPA squad has a little bit of all of that. Oh, that's great. Now, based on your, in the trenches, leadership with a small firm, based on manufacturing, what is the future of manufacturing in Hawaii? How can you grow manufacturing or get more people and become entrepreneurs in manufacturing and selling products out there? What did you learn in all this? So you have to find your niche. That's what I learned. You're never gonna be able to compete with Costco. You're never gonna be competing with Amazon. You have to find your niche. We found our niche in making custom specifications, custom trash liners. You need it four mil thick for trash from foreign destinations, or you need it six mil for asbestos or this or that. We can manufacture that and we can make it a run as something as small as 10 cases. So it's that customer service. It's that being able to manufacture things at smaller runs that larger manufacturers don't wanna really touch. And where do you get the materials? When you say manufactured products, the materials coming from vendors outside Hawaii and they come and then you manufacture products at your IAEA manufacturing plant? Yeah, so the majority of our raw materials come from Yakima, Washington as recycled plastic and then we get some food grade plastics from the West Coast LA. But yeah, that's a... So you're a renewable company in many ways. So we strive to be as green as possible. We put 546 photovoltaic panels on our roof to try and generate as much sustainable electricity as we could. That generates about 20% of our electricity needs. There you go. Yeah. It's on the screen. Yeah. So yeah, we tried to get more but that was the max we could put on our roof. We use as much recycled resin as we can. It's more affordable and it makes sure that's nothing's wasted. We have our own recycling machine on premises so we can recycle any scraps that we create so we're not wasting anything, we're not taking anything from dump. Well, going back to being an entrepreneur and seeing your parents great experience and really developing a company and growing and so forth. What advice would you tell entrepreneurs if they were going to go into that and they had a product niche that they really focused on? You talked about the sales, the relationship sales, really, really a challenge out there really but to develop that skill. Anything else? I always, I would say make sure that you've got your financing behind you because people that are not new to, people that are new to businesses think that they'll make, you know, like you see the projections, they'll make money in like month three. It doesn't usually happen like that. You usually, when you first start a company and my parents will attest to this, it hurts because you're looking at the financial statements, you're bleeding cash in the beginning to build your customer base to get the products out there to work on it and stuff like that. So you have to make sure that you've got enough financing that you can survive until profitability. So great organizations, a small business administration, they do SBA loans and stuff like that. So there are banks that do SBA loans.  We had an SBA loan when we started that was critical. So there's opportunities or ways to get started out there and if you know where they go, you can really launch your business. Yeah, so there are resources out there for small businesses. There's in the federal space, they have set-asides for small businesses that are SBA certified. If you're a veteran owned business or a disadvantaged veteran owned business and ADA certification, their contracts are basically set aside for you and stuff like that. There are opportunities for small businesses and there are resources out there for you. You just have to take, you just have to look for them. But making sure you've got that financing behind you will make you feel, make you sleep a lot better at night for sure. Great, great advice for entrepreneurs out there who may be listening and kind of thinking about their next step. So taking your company, do you see five years, 10 years out, any plans, any visions going out there or you think the competition and the business landscape will be exactly the same? So like I said, we're looking at in the next three or four years running out of production capacity. So right now we're planning, we're evaluating different types of equipment, we're getting quotes in to put in about a million to $2 million worth of new equipment in to replace our aging equipment. It's more efficient with the electric, more labor efficient, less labor hours, and it can produce significantly more. So we're looking at becoming more efficient, more effective, spending the money on the business so they can continue to grow and continue to sell trash liners, clear food, gray bags, t-shirt bags to customers. Well, you dependent also on economy that will grow. Your customer base will be in business and even ordering more from your company. So you have to be really with your finger on the pulse of the Hawaii economy looking for the future. If it grows, your company and many, many other small companies, firms grow with it. So yeah, that's a difficult thing about Hawaii because you have military and tourism as the two major mainstays. Even my customers that are not directly within tourism, I can feel when tourism's slow because the restaurants are not buying as much bags. This is not buying much bags. Because of the fact that tourism's down, it affects other businesses in the Hawaii economy. When we look at our customer base, we try to hedge against that by selling to certain industries that will be a counterweight against that so that if tourism does turn down, we still have a core business that we can rely on. Things like medical, like selling to the nursing homes and hospitals are a part of it. And then also bidding on state business, the state of Hawaii is a large user of trash liners. And then the city and county of Honolulu, the county of Hawaii, all these places bidding on some of the state contracts. You sound like a salesperson to me. With the whole sales plan and customer kind of all lined up. That's terrific. Well, we're coming to the end of the show and I think we've had a great discussion with Adrian Hong, Island Plastic Bags president. And I think he shows the dynamism in manufacturing in Hawaii that many people really don't see but it's really out there and with hard working people to really drive the economy and make us less dependent on imports and have a thriving business for many, many small firms out there throughout the state. So thank you very much. And this is Business in Hawaii standing in for Regi Baker. My name is Regi Yama.