 Good morning and welcome to this public meeting of the United States Consumer Product Safety Commission. Today we're going to consider one agenda item, a draft notice of proposed rulemaking for a prohibition of children's toys and childcare articles containing specified phthalates. We'll start, as usual, with five minutes for each commissioner to ask questions of staff regarding the proposed rule package. The staff members with us today are Dr. Kent Carlson, Dr. Michael Babich, and Mr. Dave DiMitteo. I'm going to begin with the questions, and actually I don't have any questions, so Commissioner Adler, if you have any questions? I have no questions. I do have a statement, but I think I'll withhold it until questions have been asked. Commissioner Robinson. I do have a few questions, Mr. Chair. But I would first like to make a couple comments. One is that I know our staff has put in an incredible effort on this, and I thank you again for the effort, and particularly Dr. Babich. But I also would like to thank, by name, the CHAP members for their years-long dedication to this groundbreaking report. Those people were Dr. Chris Jennings of Virginia Commonwealth University, Dr. Russ Hauser of Harvard School of Public Health, Dr. Holger Koch of Rohr University in Germany, Dr. Andreas Kortenkamp of Brinell University in London, Dr. Paul Leoy of Robert Wood Johnson Medical School, Dr. Philip Merkis of the University of Washington, and Dr. Bernard Schwetz of the Department of Health and Human Services. They're just like to thank each of these people for their incredible effort in putting this report before us. And I'd like to just to say a few words about the process from the perspective of Congress, the CHAP, and the CPSC. Congress has put in place our process so that what we're doing today is a bit unusual because we have specifically mandated procedures that we are to follow. And one may assume that this process was mandated by Congress because we're dealing both with an important emerging health issue concerning chemicals that may have varied and profound health impacts and which are economically very important. And we have emerging science on phthalates and phthalate alternatives. However, even though the hazard and science are emerging, we know enough now to appreciate the grave dangers these chemicals pose to our most vulnerable populations. And I thank Congress for putting us on the path that we're on today. The process with respect to the CHAP, I would just like to say, it was presumably longer than Congress anticipated, but that is commensurate with the complexity of the questions at hand. The CHAP conducted a thorough and extraordinarily open process which allowed many members of the public to take part. My understanding is that the CHAP held at least seven public meetings. They solicited information from a variety of stakeholders, including industry representatives, academic experts, federal regulators, and NGOs. And they invited scientists to present their cutting edge research. Many manufacturers and other interested parties provided information both to the CPSC and the CHAP. And that information was taken into consideration. And also, I applaud the CHAP for, without any requirement to do so, inviting a peer review of the draft of their final report. So all of those steps are reassuring to me that the scientists on the CHAP understood the gravity of their recommendations, and they wanted to get it right. And then we have a process, the APA notice and comment period that we are now embarking on the second public phase of this. And in this phase, it is contemplated that if a majority of the commission agrees, we will publish the staff's recommendation related to the CHAP, and we will receive comments from all of our stakeholders, industry, trade, consumers, scientists, and even other agencies. And at the end of the comment period, of course, following this process, the staff will review those comments thoroughly and submit to us a draft of a final rule. That's how our process works. And I'd just like to make one comment on the new data. It's always tempting to wait until the next study comes out before we pass a rule. And certainly this is an area in which the science just continues to pile up with respect to the research that's being done. But we do not have that luxury, because Congress has mandated that we act quickly and our most vulnerable populations are at risk. So we have enough information to move forward. I have a few questions of Dr. Babich. I'm not sure where I am on the time, and I may have to wait. I have one minute. So I'll start. Dr. Babich, we've heard a lot of discussion about various sets of NHANES data for different years. And I'd just like to start by asking you, are there differences from cycle to cycle with the NHANES data in terms of their focus of the survey? Yes. Apparently NHANES does make changes to their sampling and focus from cycle to cycle so that, for example, 2005, 2006 was the last year where they focused on pregnant women. In other years, various years, they focus on different health endpoints. Some years would measure things like blood glucose and blood lipids, which, as many of us know, requires fasting for that test. So yes, there are differences from year to year, differences in the sampling, and so on, even in the chemicals that they test for. I'm out of time. I'll wait for the next one. Commissioner Buerkle. Thank you, Mr. Chair. And again, thank you to the staff for being here and for the questions we received, excuse me, the answers we received to our questions. My questions this morning are pretty much going to be from the response that Chairman K received regarding his one question, clarifying the NHANES data sets reviewed by the CHAP. So, and I don't know if I'll get through it in the first five minutes, but I understand we'll have more time to ask questions. Dr. Babich, do you know when the CHAP did its initial analysis of the 0506 NHANES data? I know that I can't say exactly when they first analyzed their data. I know that they reanalyzed it in early 2012 after the 0506 data were revised. So you don't know between? Well, it's they first raised it at the idea of doing it at the third meeting. And without going through all the notes and meeting logs, I mean, I could do that and find out when they first had results. In the reason I'm asking that is because now, for instance, you're saying it looks like they may have started before the third CHAP meeting, around the third CHAP meeting. Looks like they could have used the 0708 NHANES data, at least to that point. But my question is it seems odd to me, and it seemed odd to me from the time we began looking at the CHAP report, that they only use the 0506 NHANES data. But they established a deadline much further beyond that 0607 data, beyond 2010. And it just seems odd to me why they set the deadline at this point in time, which we have here as 1231 2012. But then they didn't consider anything once they considered the 0506 NHANES data. So that's why I'm trying to understand it. If you could give us a date when they reviewed that, that would be very helpful to me in my understanding of how and why they only use the 0506 NHANES. A date when they reviewed which data? The 0506. The 0506, it was sometime after the third CHAP meeting. So probably sometime in 2011, but I'm not sure exactly when. When they first did their analysis of the 0506 data. It just seems odd to me. If that's when they did their analysis, why they wouldn't have considered the 0708 NHANES data. And it's total totality rather than just the summary. But let me go on to my next question. Is there any reason to believe? And if you know, I don't even know if you would know the answer, because again, this would be the CHAP's information, that they might have used some estimates developed by one of the CHAP members to derive their own independent estimates? I'm not sure what you mean. Is it possible that they could have used one of the members of the CHAP had estimates developed? Is it possible they could have used those or considered those in their analysis and that first analysis? Estimates developed of? Regarding the exposure rates. Exposures from the NHANES data. Well, there is a big table in the CHAP report that cites all published information, other people's assessments of biomonitoring data. And that includes some studies published by Dr. Koch, among others. And does it include Dr. Cortencamp's? Well, Dr. Cortencamp did not, as far as I know, didn't do any analyses of the NHANES data. OK. Let me get, move along here before I get the hook here from Bertha. In what way, because in the response to the chairman, it says that the 56 NHANES data was revised in 2012. And the answer says that there's two reasons why the NHANES data are revised due to errors in chemical analysis or errors in statistical weighting of the NHANES population. Do you know the revision to the 0506 data? What the reason was? I'm pretty sure it was an analytical issue, the analytical chemistry part. OK. So which would that fit under, the phthalate measurement or the sampling? Yeah, the phthalate measurement part. OK, good. I see my time has expired. Thank you. Commissioner Morovic. Thank you, Mr. Chairman. Mr. Chairman, I'd like to start with a compliment. Somebody who hasn't been recognized for their contribution here, maybe not as directly as our general counsel. Mr. Comis, I know I won't reference our legal memorandum in any way as it's privileged, but I've paid compliments to your staff who are the main authors of it and I found it incredibly thorough and informative for me. So I appreciate that very much. I have only one question for staff. Mr. Babbage, I watched the hearing earlier this week. And getting back to the decision point, regardless of the CHAP's decisions with regards to going back to running the subsequent data, the exposure data, which is critical for the methodology to consider it, whether or not we've got a significant reason or health impact to further the ban on DINP. In looking at the hearing, you mentioned that, and you said the word you, so I don't know if you meant the team that was working you yourself or the team that was working on this, that you were advised not to run the subsequent and more updated data sets. Who advised you not to run those data sets? My management, because under the statute, the rulemaking, the proposed rule is to be based on the CHAP's analysis and not the staff's. Who by name? You know, it comes down through the chain of command. Is this a secret? No, and I believe that I was told that it came from J. Howell. OK. Because that would seem to me to be a advice based on a legal analysis of the statute, not a technical one. Well, it doesn't mean, you know, he's the decision maker. It doesn't mean he didn't consider any legal advice. Is Mr. Howell here today? Can I ask him if he was advised by anybody to, or Mr. Borlaze, did you have anything to add to this? Mr. Chairman, just a brief point of order. I'm getting extremely uncomfortable at the inquiry that is approaching legal analysis. Because as Dr. Babich has said, the advice he got may well have been premised on a legal as well as a policy or technical point. And so I would just urge that we proceed with caution so that we don't cross this line into legal analysis. And I'll ask my colleague to bear with me, because I've had some scars in past years about drifting into legal analysis. I'm going to sustain that point of order and ask that Commissioner Mohorovic just try to be careful of any issues that may tend toward the legal analysis. And if there is questions about deliberative internal processes that can be answered by staff in a separate proceeding or a separate setting, we're happy to do that. I agree, Mr. Chairman. I do also agree, and I'm sure you do too, that sunshine is the very best disinfectant. And the big picture of what everybody's looking at and why we're all focusing on these data sets is people want to know, just rationally, looking at why we didn't study or why the CHAP didn't study. We don't have the opportunity to ask these questions directly of the staff, of the CHAP scientists, why they chose to ignore subsequent data sets, which were critical to providing and informing the risk assessment data. And I know we may have an opportunity to do that ourselves outside of the CHAP through the notice and comment period. But the reason I'm asking this is I want to be able to reassure anybody who is concerned about this process that, in fact, decisions were made, not, in fact, to ignore data so that the data that was used makes the case to make the ban, but that it was ignored for a perfectly good reason based on a statute and not getting into the legal interpretation and how that was made. But if, in fact, it was a legal determination that from a clear reading of 108 led one to believe that our staff's hands are tied, then I'm more comfortable with that. And I appreciate the direction, Mr. Chairman, that you've given staff, to have them review it. It's very much my hope and desire that that direction to staff does include fully running the exposure data, because I don't think anybody involved in this process is afraid of what subsequent data, more recent and relevant data, might reveal to help inform our decision-making. So I appreciate the advice from my colleague, Commissioner Adler. Thank you very much, Mr. Chairman. I hope I didn't get too close to any guardrails with my further testimony here. Thank you, Commissioner Moorover. Commissioner Adler. I do have one quick observation and one question. And the observation is, in response to Commissioner Burkle's question number 8, with respect to the staff analyzing more recent exposure data, the staff says that they plan to analyze the hazard index calculations for pregnant women using the 2011-2012 and earlier NHANES data sets in the same approach and methodology as the CHAP to the extent possible. And so it seems to me that the concern that's being raised is going to be addressed. But I want to ask a slightly different question, if I might, Dr. Babbage. And that is, based on your assessment of the notice proposed rule-making and your involvement in it, are you comfortable at this point in making the recommendation you've made that the Commission proceed to publish the notice of proposed rule-making? Yes, I am comfortable with that. I thank you for that. Commissioner Robinson. Thank you, Mr. Chair. Again, Dr. Babbage, we seem to be drifting into getting sloppy about the term data. So I just want to make sure that we're all on the same page as to the different types of data that the CHAP took into consideration. Now, as I understand it, the data that is the medical research, the peer-reviewed published medical research, was research that was taken into consideration by the CHAP if it was published before the end of 2012. Is that right? Correct. And it's described in the CHAP report. And it says that they updated, basically included published literature, journal articles, up until the end of 2012. At least that's when their last time, they updated their literature search. Originally, they had planned for the end of 2011. But after the delays in getting the report out, they extended it to 2012. And they did include one or two papers that were published in 2013, actually. And the medical research that you're speaking of now is what is telling us about the molecular construction of the phthalates, what effects they have, in particular the anti-androgenic effects on different species. Is that right? Exactly. It's about the health effects of phthalates, yes. And the NHANES data is of a totally different nature. And that is that it's measuring exposure in different populations to phthalates. That's right. It is. And in fact, the CHAP in the report, it says very clearly that their assignment, their charge from the CPSIA was to look at pregnant women. And they looked at pregnant women in 2005 to 2006 as the last year that the NHANES focused on pregnant women. Subsequent years do not have large numbers of pregnant women. And looking at this exposure and given what this agency's jurisdiction is, when we're looking at the populations that we're really concerned with, are pregnant women, fetuses, and infants. Is that right? Correct. And NHANES does nothing to measure exposure of anyone under six years of age. That's true. So the focus that we would care about with respect to NHANES would be on pregnant women, right? That's right. OK. Do you know if the 2009, 2010 NHANES data measured the glucose and lipids requiring fasting that you referred to earlier? I think so, but I don't know for certain. If it did, would that affect the levels of phthalate and metabolite? Well, what? If comparing it with the O-bibose? Yeah, the issue is fasting. And I think that's one of the reasons the CHAP mentioned. But the issue is fasting. And how would fasting affect the exposure levels? And the CHAP invited people to come in, and scientists to come in and talk about this issue. They spent a lot of time talking about it. And my understanding is if you're fasting, if anything, that's likely to lower your phthalate exposures, because if you look at people throughout the course of a day or a week, you eat breakfast, you get a spike in phthalates. And part of it's associated with meals, other phthalates, like diethylphthalate, not one of the ones we're worried about in the CHAP report. But you might get that in the morning from personal care products, for example. So you could see during the course of a day when you get what phthalates, if anything, I think fasting would probably lower your exposure. I'm out of time. I'll wait for the next round. Commissioner Burkle. Thank you, Mr. Chair. Dr. Babich, when we last spoke, we left off at the revision of the 0506 NHANES data. Did the revision in 2012 of that 0506 NHANES data, did it affect the CHAPS calculation? Well, it changed the calculations, but I don't think it changed the conclusions. I think they still had the up to 10% of the pregnant women exceeding a hazard index of one. I don't think that changed significantly. So they didn't revise their analysis then? Well, they did. They redid their analysis, but I think the result, the bottom line, was the same. The conclusions were the same. The 2007 NHANES data was revised after the initial release as well. Do you know if the revisions of that data affected the thalate measurements, or was it more the sampling weight? Was the issue that they? That, I don't recall. 2007, 2008 data were revised to account for sub-sample weights and first, and then they were revised later to account for the analytical differences. And did those revisions, did they have any effect on the CHAPS analysis? I think the CHAP used data from 2007, 2008, the summary data exclusively, so they would have taken that into account. OK. So now this is, I heard, I saw it yesterday in the responses to the chairman's question, and we're referring to it again today. And as my colleague mentioned, sloppy about the data. What is a data set summary? Or I should say, what's a summary data? Summary data, for a given thalate, CDC publishes reports in, actually not for a thalate, but for a metabolite. They give the data in two forms. They give the concentrations in urine and in one corrected for creatinine. And they give, for example, a geometric amine, 50th percentile, 75th, 90th, and 95th percentile. And they present actually data for several years. OK. So what I'm holding in my hand is the data summary. Exactly. I just wanted to clarify that then. OK. So we go back to that 0708 NHANES summary data, not the data set, but just this piece of paper here. Did the revision to the 0708 NHANES data affect the summary data? Well, most likely it did. I don't know how much. OK. OK. When the 09, and I apologize. It seems like I'm in the weeds on this data. But I think the best way to get this proposed rule right is to make sure the proper and the correct data was used. And that's why I want to make sure I'm clear on this. When the 09, 10 NHANES summary data first became available, was it included in the September of the data set, September 2012? Was the summary set available at the same time? In 2012, there were data available. I'm not even sure if it was the complete data. And I'm not sure when the next summary report was published. OK. Maybe we could clarify that. And we can talk about that. I can get the answer to that after the hearing. What my next question has to do with the 09 and the 10 NHANES data, did that show lower exposures to DEHP? Apparently, yes. OK. And so everyone knew that CPSIA in 2008 banned the use of DEHP. Did the CHAP at all consider the fact that after following 2008 and the ban of DEHP that those rates would go lower? Well, yes, the CHAP discussed that. But those rates in the US did not change. Those exposures didn't appear to change until the 9-10 data, whereas in Europe, they had been changing over the same 10-year period, roughly 2010. There was a steady decline in DEHP and a steady increase in DINP. We just didn't see that in the US until the 9-10 data. OK. And my time has expired. And I do want to get back to that point, because I keep hearing DEHP decline, but DINP increase. And I want to make sure we're clear that those are not equal values. Thank you. Commissioner Moherova. Mr. Chairman, as a point of professional courtesy and continuity sake, may I yield my five minutes of questions time to Commissioner Burkle so that she may continue her line of thought? Absolutely. Thank you, Mr. Chairman. Thank you, Mr. Moherova. So I guess I want to make it clear that DEHP is not, and I won't say this very artfully because I'm not a scientist, but DEHP is, and it was a far larger contributor to the cumulative risk assessment than DINP is. And I think, believe in the staff briefing, they also articulate that point. Is that true? True. And what would you say the value, the DEHP value, is the factor greater than DINP? DEHP contributed anywhere from like 50, depending on the case and the population, from more than 50 up to maybe 90% of the hazard index. For DINP, it was somewhere between 1% and 15%, depending, again, you're looking at pregnant women, infants, and which of the three cases. I just want to make sure we all understand that when you say D, because I have this, DEHP came down, DINP went up, but not in equal proportions or not in equal amounts, they're two very different values. Well, the concentrations, what I just said was about the hazard index. The concentrations in people's urine, just that sort of raw number. DEHP is going down, DINP is going up. Diabutyl is going down, isobutyl is going up, or something like that. I'm not saying, I didn't look at the magnitude, and I didn't do any calculations as to how that might affect the hazard index. So I'm not saying it's necessarily a one for one. OK, that's very important. Does the SFF data, we talked about that a little bit in the timeline, does that data permit analysts to derive nationwide estimates? It's not a statistical sample in the same way that NHANES is. OK, can you clarify that? Well, it's not designed to provide national estimates in the same way that NHANES or say NICE is. OK, and what does that mean for us non-SIM agents? It's a large sample of people from at least two different cities, two different socioeconomic groups. So it's without being statistically designed to be statistically representative, it's a pretty good study. Except for this SFF data that was used was 1999 to 2005, so that was even older than the NHANES that was used by the CHAP. How am I doing on time? Yeah, well, the SFF, using the SFF data, the CHAP found that up to 5% of the pregnant women and up to 5% of the infants exceeded a hazard index of one. But that was old data. Well, it was the only data on infants that were available. And it may still be the only, or the best data available. OK, on the timeline, and we were very pleased to see our timeline was used, gives it a lot of credibility by the chairman's office, it mentions here that the CHAP revised its cutoff date. Do you know why they did that? Because probably because the report was delayed and also because they wanted to include, there were certain studies that had been published that weren't published in 2011 that were significant. The studies on the xenografts, the transplanting human and mouse tissue and serats primarily, and they also included some additional data on DINP. OK, well, I guess my question is if they were willing to consider those later articles as late as 2011 and 12, why wouldn't they have done an analysis, not just on the data summary, but on the entire data set of the 0708 and then the 0910 data? I don't understand, and I think my time has expired, so I guess we'll have to get back to that. Thank you. Dr. Babich, I want to follow up on what I thought was a fascinating line of questions by Commissioner Robinson on the issue of pregnant women and the NHAIDS data. And fair to say that pregnant women as a vulnerable population are a required subset of the population for the CHAP to have looked at and for the commission to consider. Well, that was part of the charge from the CPSIA. And so can you explain a little bit more at what point from an NHAIDS data set did the amount of pregnant women that were included in it go from being a large subset of the NHAIDS data to not so large? Well, the 0506 is, as I understand, is the last year that had where they studied pregnant women. Subsequent years have much smaller numbers. I think if they, whatever their process is, if some of the women who were examined happened to be pregnant, that was included in the study, but they didn't specifically look for pregnant women. And does that change the relative value of the NHAIDS data set as part of the larger cumulative risk assessment? Well, certainly the CHAP felt that way. And head of staff feel, I'm just curious. You know, if you're, you'd much rather use the most appropriate data than a surrogate. Okay. I also want to make for a turn to Commissioner Adler who I'm sure has more questions. I do want to make a comment and I'm sure that as we continue and discuss this NPR today, we're going to, there's going to be a lot of focus on the NHAIDS data and I think it's a little troubling and it's going to be why I'm going to be supportive of publishing this NPR as quickly as possible because there's so much more to what the CHAP looked at and what the CHAP recommended than NHAIDS data and its effect on one particular interim ban. And I think we've lost that in this discussion. I really do. It could turn out years later that this was almost a waste of time because the CHAP identified other phthalates for action and other phthalate alternatives for study that could, they may not, but they could have had a much greater impact on public health than this one interim banned phthalate. And it's disturbing to me that there's been so much attention on this one particular aspect and I believe that's because we haven't yet published the NPR yet, the one understandably affected party by the CHAP's proposal to make that ban permanent has continued to engage the commission. And I believe that the best path forward is for the commission to open this discussion up to the general public, not just one party, which is having in my mind basically an unfair influence on the focus of the commission on the larger issue. Commissioner Adler. Thank you, Mr. Chairman. And I'm just reflecting on the fact that the commission, and I'm gonna return to this point, has been struggling for years with what we call chronic hazards. And when I left the commission back in ought 84, we were talking about phthalates and when I came back, lo and behold, we were still talking about phthalates. So I guess one question I would have Dr. Babbage is relative to a lot of the other chemicals that are suspect that have been examined. How would you characterize the degree of research and study of phthalates compared to some of the other chemicals that are currently at issue? Yeah, well, you know, phthalates are some of the best studied chemicals as a group. And, you know, the studies on the phthalates syndrome go back to what, 1980, maybe the late 70s, was when the seminal work was done. And so, you know, that's been known for a long time. And yes, they are among the best studied chemicals. Or to put it another way, when you're studying chronic hazards, especially things where there's a cumulative risk and there are other chemicals that are confounds, it's a major challenge. And so in a certain sense, you have to look at phthalates and say, this is as good as it gets, and it's pretty good, but this is as good as it gets. And it sounds like you can always poke holes in any data set, but by and large, there's a narrative that emerges from this. And I think the narrative is a pretty clear one. And I would echo the sentiment of the chairman and saying that because of that, I'm gonna vote to propose this and the best way to advance the issue is to get more input from stakeholders and not just one stakeholder. Commissioner Robinson. Dr. Babbage, I have a couple of questions to follow up on the hazard index, but before I do that, I just wanna follow up for a moment on what Chairman Kay was saying and where we left off in my last round of questioning. There are two types of data that the chap was looking at, as I understand it, the medical research and they were looking at the effects that phthalates can have on different types of mammals. And then the other type is the only thing we have for humans and that is the exposure rate to phthalates. And when we look at the two populations that are relevant to us, we have the best data and the most recent data absolutely with respect to anyone under the age of six after a baby's born, right? And then, so the only population that seems to be getting a huge focus from our one party as Chairman Kay mentioned is on pregnant women. And the only recent study done by NHANES where they focused on pregnant women tried to find pregnant women as opposed to having pregnant women included if they happened to be pregnant was the 0506 data. Is that correct? Correct. Let me just ask just a quick question, a couple of quick questions with respect to the hazard index because the argument seems to be that if we looked at the general population in the NHANES data of 0910 that the hazard index had gone below one. As I understand it, the hazard index is a standard tool for risk assessment, is that right? Yes. And they calculate the hazard index by adding the hazard quotients of each active phthalate which in turn is determined by dividing the exposure rates by the potency estimate of androgenicity or PEAA, is that right? Correct. And as I understand it, the CHAPS report in reading it, they say that the PEAA, one element of that equation is not a bright line. Is that right? Well, correct. Whether you look at the hazard index, no effect level or the PEAA, none of these is a bright line. These are estimates, the hazard index, the PEAA is an estimate of a level that you can be exposed for a lifetime with a negligible risk of adverse effects. It's not a bright line. And the CHAP talked about this and they were very concerned that people might perceive their results as a bright line. And the world doesn't work that way. It's not like you have a chemical up to a certain point and everything's just fine and dandy and you hit that threshold and you keel over. It isn't like that. And it actually, whether you call it a hazard index of one, a cancer risk of one in a million, that's what you might call an unacceptable risk. And that's sort of a default value. But in reality, it's up to the commission to decide what's an acceptable risk for a given product for the affected population and so on. I have nothing for everything. Commissioner Birkel. Thank you, Mr. Chair. I'll get back to my questions and then I do have some other questions based on the other commissioners' comments and questions. I was delighted to see in my number eight question that staff does intend to read the response. Staff plans to analyze the hazard index calculations for pregnant women using the 1112 and earlier NHANES data sets and the same approach and methodology as the CHAP to the extent possible. And I guess I'd like to know what, if any, factors would make that not possible. Well, I think that in discussing this with our statisticians, they pointed out that there are differences in the CHAP data sets from year to year. So they made a couple, well, there's a couple of points. One is the number of pregnant women gets much smaller. And I don't know if that's big enough to make reasonable estimates or whatever or to look at statistical significance. The other, another issue is that due to changes from year to year in the study design and the numbers of people in the studies, that makes it a little bit difficult to do an analysis comparing from year to year. So they, you know, they're not saying it can't be done. They're saying they don't know that these are complicating factors and they don't know if they can make a statistic, if we can end up showing statistical significance, for example. So just, you know, a caution that it's all things are not, you know, all things being equal, yes, we could just go do from year to year to year, but all things are not equal and we won't really know until we do it. So the analysis can be done. It's just a question of running into these complications. And I keep hearing pregnant women, but the CHAP looked at women of reproductive age as well as pregnant women, didn't they? Yes, they did. And they considered that? Yes, well, you know, if you can't do pregnant women, you can do women of reproductive age, or you can even do women of reproductive age and adjust for the birth rate. But, you know, obviously pregnant women is the best way to do it. Obviously they're physiologically different. They, their diet is different. Okay, would it be possible, and maybe I could ask you what the staff would need to provide the analysis of that later data, those two data sets that the CHAP did not consider by the end of January when the public comment period is still open and that, and make that publicly available, so stakeholders. I think that would be, there's no way we could commit to having it done by then. What would you need? What would we need? You know, I'm not sure it's even a resource issue. It takes time to do this and to do it right takes time. Okay, I guess when we had the ops plan hearing actually, I asked the question about whether or not we could do that analysis. Staff had the resources and staff had the ability to provide that analysis. And the answer I received was yes. Well, yes, but not necessarily by the end of January. Okay, how much time do you think it would take? You know, we estimated, what, five and it's staff months or something like that. I mean, it's, you know, it's, it's hard to estimate these things. But, you know, I, I'm not gonna, I don't wanna promise a deadline that we end up not meeting. Okay. Well, I hope, I really do hope that the chairman will talk to staff and see what's possible and making that, getting that done during the public comment period and allowing the stakeholders to see that information. I think that that would remedy a tough situation that we have here. I see my time has expired, so I'll end here. Thank you. Commissioner Mohorovic. Thank you, Mr. Chairman. Just to follow up on that point. I am concerned that we didn't run the updated exposure data by virtue of, of a management decision not to run that data. And now I'm even further concerned after being reassured, more reassured last week that in fact, the integrity of the data that informs public decision making will be as recent as possible that now perhaps by virtue of time or resources, we may not have the opportunity to run the subsequent data. So beyond the point of what our decision be based on the CHAP report or not based on the CHAP report, I feel a responsibility as a commissioner to only promulgate a rule if I feel, I don't feel that I'm a rubber stamp for the CHAP. I don't think the CHAP was nominated by the president. I don't think the CHAP has rulemaking authority. I don't think that they, anyone was confirmed by the Senate. So therefore I feel it's my responsibility as a commissioner to either vote for or against a rule based on the best available and sound science. And we've clearly discovered here that the science that's available through the CHAP is old and it lacks being informed by the most recent exposure data. Now, I don't think that if we were, if the staff felt compelled to base the recommendation based on the CHAP report, that would have been fine. But to me, a more preferable outcome would have been, well, based on the CHAP report, we have to conclude this because the statute says that we must base our decision on the CHAP report. However, we've run the numbers with more updated exposure data and lo and behold, the methodology that was used to buy the CHAP to recommend further banning DINP has now changed. That may not change our recommendation, but at least it would allow me as a commissioner because I don't feel my hands are tied to rubber stamping a CHAP report for whatever reason they used as legitimate or not in ignoring the subsequent data set because folks from the outside, I think Chairman K made a great point and I apologize, I shouldn't try to put words in his mouth, but the way I interpreted it is we're losing the forest through the trees with this focus on DINP. I mean, after all, I mean, I've come from the private sector where regulated entities have had to live within this interim ban and they have been, they have been successfully. They've kept DINP out of these products for some time and after all, what are we looking at? We're looking at furthering the ban on something that's already been banned and we know that what the reality is in the regulatory market in Europe, so why are we focusing so much on DINP and the reason why I feel it is important to focus on it is because of the integrity of the process that we use to inform decision making and I'm very concerned that the adequate time or resources won't be brought to bear to better inform our decision making because after all, from the outside looking in, skeptics will say we cooked the books. You cooked the books, you didn't use the subsequent exposure data. I appreciate it, Mr. Babbage, but also I've heard you say for years that there's been no health risk with regards to the products under our jurisdiction from DINP and here you are, you're on the donkey, riding on the road to Damascus, there's a bright flash of light, you're knocked off, you come up and you, new conclusion. So now all of a sudden, DINP is a health risk. Now that may be bound by a very poor, poorly constructed statute. I was at a, I was at a talk. Can I respond to that? Maybe in a moment, but I only have a minute left. I was at a, I was at a talk from Cass Sunstein and former EPA administrator, Carol Browner, yesterday and they talked about being, being hamstrung by poorly constructed statutes and anybody looking at 108 will find it varying all over the place from FHSA to CPSA to APA and it's all over the place. So God bless our legal staff and in the work that they did to try to interpret our best direction moving forward. But in the end, we're going to have to make a decision here as commissioners and I want to make that decision based on the most recent, relevant science. And right now we don't have it and I'm concerned that staff won't be giving the time or resources or management will prohibit them from doing so. And that's what concerns me moving forward. Thank you, Mr. Chairman. Thank you, Commissioner Mohorovic. Dr. Babich on the DINP question. I assume that if there is a discrepancy it relates to the difference between DINP and isolation and DINP as part of a cumulative risk assessment. Is that correct? Well, that's correct. Not only that, the 2001 CHAP said DINP is unlikely to present a hazard or something like that, but it's one phthalate and they were very concerned about exposure to all phthalates. The CHAP or excuse me, the staff report in 2002 says DINP is an operating however we need to look at exposure to all phthalates. And also to reiterate a point that I made during the briefing on this, the statutory charge is different. Is it not between the FHSA and section 108 of the CPSIA? Well, I'm not sure about that, but it's been recognized since the time of the previous CHAP that a cumulative risk assessment needed to be done. At the time we didn't have the scientific tools to do that. And in recent years we have them, so. Well, I apologize, I asked a legal question to you or at least a question probably better answered by an attorney, Mr. Dimiteo, do you have an opinion on whether or not FHSA and CPSIA require the same analysis? In terms of promulgating a rule, yeah, the requirements are not the same. The FHSA is a rule, a statutory provision that requires a certain process be followed, whatever you're trying to prohibit under that. The section 108 of the CPSIA is specific to this particular thing and in fact I would add, typically if we do a rule under CPSIA or FHSA dealing with the CHAP, we appoint the CHAP and then we tell the CHAP what the charge is. That's not the case in this instance and in fact this instance, Congress took that away and said, here's what your charge is, here's what you're gonna look at. So that's how I think it differs in a significant way in that regard. Thank you. As well as the actual requirements that you're required to do to promulgate a rule. Thank you for that and this is for anybody in the panel. Does anybody in the panel feel that they've been directed by anybody in management not to dedicate the time necessary to whatever analysis, so I'm gonna get into that later, but whatever analysis staff believes from a scientific and technical basis is necessary in reviewing the comments to the NPR? No, no. Dr. Carlson, and has anybody on the panel received any direction whatsoever from management that there are any other limitations or any other specific directions as to what they must do or not do from a scientific or technical basis? No, I can't speak to that because I'm a lawyer. How about from a legal basis? No. Dr. Carlson, okay, thank you. Commissioner Adler? No, thank you very much and first of all, Dr. Babich, if you wanted to respond in greater detail to Commissioner Mohorovic, if you want to do that, please feel free to do so on my time, otherwise I do have a question and comment. Well, I think I made the point. Yeah, and I wanted to make a couple of points as well. First of all, I don't feel hamstrung by section 108. I feel inspired and guided by that. I think that is more appropriate public policy for addressing chronic hazards than what the current state of the law is, including the Toxic Substances Control Act. Those put too much onus on the government to prove a product is dangerous as opposed to those who are profiting by it to demonstrate that their product is safe. And this to me sets the proper balance in terms of moving forward in addressing a chronic hazard. So I cherish and admire section 108. But there's one other point I want to make and that is based on the statements that you made at the previous briefing, it seemed to me that you were saying that this subsequent NHANES data is interesting, it might change some calculation, but basically it's unlikely to change the recommendation that the staff has made. And secondly, if it should turn out to be so, staff would not hesitate to come back and say we've changed our calculation and we have a different recommendation and the commission therefore should repropose its action going forward. Did I misunderstand that or is that your understanding? No, not at all, that's my understanding. Okay, and I thank you for that because I don't feel that staff is being asked to rubber stamp anything that the chap did or anything that senior management has asked them to do. We've seen previous administrations that were accused of having policy dictate science. If there's one thing I have admired and loved about this agency, is that we let science form the basis for establishing policy. The day that we would ever come close to letting policy folks tell scientists how to do science is a day that I would dread and I would never want to see at this agency. Commissioner Robinson. I think that there was much confusion in Commissioner Mohorovic's comments about recent versus relevant. I only heard him mention the word relevant at the end of his comments and I take great exception to accusing us of being rubber stamps or having our hands tied. I think exactly the opposite is true and then when he moved into phrases like cooking the books and accusing Dr. Babich of changing his position when he was testifying prior hearing under a completely different standard is really inappropriate. Congress asked the chap and our staff and us to look at the cumulative effect of phthalates, of certain phthalates. It was only in Commissioner Mohorovic's last statement that he said the word relevant and what Congress told the chap, our staff and us to look at in terms of data on which to base our decision is the most recent relevant information. That was the mandate from Congress. I'm delighted that the staff is going to be looking at the 0910 data which is only to do with one only has information with respect to women of child bearing years. It is not the most relevant data with respect to the pregnant population which is where we have been focusing and I think given the populations that we're to examine for this rulemaking that the chap has done an admirable job of considering the most recent relevant information. We will add this information from the 200910 to the staff's comments for the final rule but I'm very comfortable that I am not a rubber stamp. My hands are not tied and we sure as heck are not cooking the books. Commissioner Berkel. Thank you, Mr. Chair and I couldn't agree more with my colleague Commissioner Adler with regards to letting science dictate policy and so that's why I implore the commission to make sure that and to really make every Herculean effort to get the staff's analysis of that more recent data done and out during the public comment period because that would let staff know the public's comment and the scientists who are concerned about this issue that would give us the science and the answers to our question in order that we promulgate a rule that makes sense and is based on the right data. I just have one more question and that is in the staff's response to my question number 11. It states, I should probably read the, my question was does the staff intend to establish a cutoff date for new scientific studies and data to be considered in rulemaking? If so, will it be the same as the CHAP's deadline of December 31st, 2012? And the response I received says that it will, the staff will consider new scientific literature that is published at least through the end of the public comment period for the notice of proposed rulemaking. So my question and I just have a couple of questions. Number one, over and over again, I've heard that our rulemaking is based on the CHAP. That's what we were mandated by the statute. So does the staff believe that CPSIA section 108 limits its ability to consider studies that were not considered by the CHAP? To the extent that you may be asking for a legal interpretation regarding that, I would say that's probably not appropriate for discussion in an open meeting. The General Counsel's Office would certainly be willing to discuss that in another forum. Can you opine without giving me legal advice? Is there a difference? I would decline that opportunity. Yeah. Excuse me, please come to order. Thank you. Commissioner Buerkle, resume. Well, how will the public know whether or not they're going to consider any additional data that comes in? What I can say is if you submit something during the comment period, we have a legal obligation to consider that and respond to it at once. I can tell you that. That's not giving legal advice. It's a legal fact of the notice and comment process. OK. And so I would have to talk with the counsel about that. Yeah, that's what I would have asked. And I'm not sure if you're going to consider this a legal question, but I'll ask it anyway for the record. And then we can, if a newly published study casts doubt on determination, maybe Dr. Babbage, this is more for you, made by the CHAP. Does the staff believe that the study can be given weight or not? I mean, I think that's kind of a question. It's got an illegal component that kind of, he can have an opinion on it scientifically, what he would think of it. But it's really a legal question about what kind of weight you can give to that versus how should the statute be interpreted, what based on means, and all that. And again, we're getting into an area that really probably isn't appropriate for discussion at a public meeting. That's all the questions I have for now, Mr. Chair. Thank you, Commissioner Berkle, Commissioner Mohorovic. No further questions. Thank you. So this concludes the round of staff questions. I'm going to move to motions. I do want to say, though, as a point of order before we do that, and I've hesitated saying something because I don't want to call anybody out. But I think the time has to come for special assistance to stop interrupting the commission. I've been a special assistant. I get it. You're passionate. You have a lot to say. But there's a reason why the five people are sitting here today, and it's only those five people. And it's not a divine right for the special assistants to sit in this room behind us or in any room and to be able to participate in this. It's a privilege. And so if special assistants cannot maintain order, they will not be welcome at commission meetings. We're now going to return to motions. Does anybody have a motion to offer? Mr. Chair, I had a statement that I would like to read briefly before we move to motions. Since we've now moved on to motions, Commissioner Anler, can we move that to the end of the meeting, please? Thank you. Does anyone have any motions to offer? No? I do not have any motions at this time, no. OK. Does anybody have any motions? Just to be clear, Commissioner Bergell, you're not offering any motions. I am not offering any motions based on the questions that we receive, the answers to the questions we received late yesterday afternoon in our conversation this morning. Thank you. OK. Hearing no further motions, we're now going to move to final consideration. I move to approve the staff draft notice of proposed rulemaking regarding a prohibition of children's toys and childcare articles containing specified phthalates and to publish the same in the Federal Register. Is there a second? Second. We have a second. Now, each commissioner has up to five minutes to discuss this motion. Commissioner Anler, of course, if you choose to use this time, this would be appropriate. Commissioner Anler. Thank you very much, Mr. Chairman. Once again, I want to thank the staff for an outstanding job in preparing the briefing package and working with the members of the CHAP on this critical topic. I also want to thank the members of the CHAP for a truly impressive performance in assessing and analyzing a massive amount of scientific data on phthalates. To the CHAP, you've served up a great report, which I've read carefully twice. With respect to the issue at hand, let me say I plan to vote to approve the notice of proposed rulemaking before us. I have several thoughts in mind, though, that I'd like to share. First, I understand that no consumer product that the commission looks at is 100% safe. Just as no prescription drug that we take is 100% safe. So just because the CHAP report identifies hazards associated with phthalates does not automatically mean that we will take action to regulate them. For example, the CHAP concluded, and I'm going to quote, that the isomeric structure of DIOP suggests that DIOP is within the range of the structure activity characteristics associated with anti-androgenic activity. Boy, that sounds ominous. But staff is not recommending that we regulate this phthalate because we lack sufficient evidence to include it in our proposed ban. I don't want to put too fine a point on the staff's recommendation here, but I actually find that reassuring. It tells me the staff took an independent look at the CHAP report and is willing to depart from the report's recommendations, depending on the staff's interpretation of the facts and law that govern our inquiry. And I want to return to a point that I made earlier. Our consideration of phthalates occurs in the context of how we regulate chronic hazards. Here I note that the commission has struggled with how to deal with such hazards for many decades. And my experience with such hazards leads me to the conclusion that regulating chronic hazards is not rocket science. It's actually much harder than that because we do not get to do basic research using inanimate objects. Instead, we have to look to animal studies and epidemiological analyses, which do not always present as clear a picture about a product's hazard as we would like. So often faced with a degree of uncertainty about the strength and scope of the danger posed by chronic hazards that does not necessarily occur with other hazards the agency addresses. Given this level of uncertainty, I struggle to know whether I'm doing the right thing and casting a vote to regulate products in this category. Certainly that's the case with phthalates. Let me pick DINP as an example. I greatly appreciated Dr. Babich's assessment of the hazards associated with this product. As he said, where the issue DINP standing alone, staff's recommendation might have been different from the one they made. Because our statutory mandate with respect to DINP is to assess the cumulative risk it adds, and that's the guidance we must follow in a few words about our statutory mandate. Specifically, Section 108 directs the agency to determine whether to continue the ban on a product like DINP, and I'm going to quote from 108, in order to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety. I love that as a standard. That is a substantially broader safety standard than the one traditionally found in the Federal Hazardous Substances Act, which requires not only a finding that a product is a hazardous substance, but also that cautionary labeling would not protect the public from the hazardous substance and that banning the substance is the only way to adequately protect the public. So a different legal standard can draw a different regulatory response, as it should. In making this point, I want to ensure those members of the public concerned about our proposed action that I retain an open mind about the issues facing us with Thalates. I think most observers know that we've met with a variety of stakeholders on this issue, and we've all listened very carefully to them. And here I want to thank the various consumer groups, health advocacy organization, as well as our friends from ExxonMobil, who've trekked to our offices to explain their concerns. Everyone has enlightened me in a thousand helpful ways. I truly appreciate the clarity and depth of the presentations made to me. I must say that the outside input has added to the input, the tremendous input that we've gotten from staff, and therefore has given me a lot of sleepless nights as I ponder everyone's concerns. But this said, what I have to do is abide by the scientific data and analysis before us at the moment, which to me clearly points in the direction of supporting the current notice of proposed rulemaking. So I'm going to cast my vote for the NPR before us, and I invite all of those who disagree with us or who support us to submit comments. Thank you. Commissioner Robinson. I am also going to be voting for this NPR, and I would just like to say that in my brief time in the last year and a half on the commission, I've come to value this notice and comment period very, very much. It's a time when all stakeholders throughout our population in this country have an opportunity to tell us what they think and why they think it and to help us in our decision making. Just because Exxon has been singled out, I don't for a moment want to in any way devalue their enormous input that they've had and their helpful input and their willingness to work to educate us. I very much appreciate those meetings and I'm sure there will be more of those. But I also want to welcome any other people out there who have input that we should be considering, whether they be individuals without education or our best academicians, our scientists, whomever. I very much welcome those comments during this time. This has been a very transparent process that we've had so far. The chap was very transparent. Our staff has been very transparent in their findings and recommendations and the bases for those recommendations and this process that we've had as a commission has been very transparent and it will continue to be so. And I look very much forward to receiving those comments, having meetings with anyone who's interested in talking to us. I will definitely keep an open mind and I look forward to seeing the analysis that our staff will do of the comments that come in. Thank you. Commissioner Burkle. Thank you, Mr. Chair. I will reserve the bulk of my comments for my closing but I do want to encourage, as Commissioner Robinson said, comment, a lot of public comment with science included in during this public comment period and I do implore the staff, if humanly possible, to make sure that analysis is done during the public comment period so that that science would be made available to those who are commenting and concerned with the proposed rule. Thank you, Mr. Chair. Commissioner Mohorovic. The discussion having concluded, I now call the vote. Commissioner Adler, how do you vote? Aye. Commissioner Robinson. Aye. Commissioner Burkle. No. Commissioner Mohorovic. No. And I vote aye. The ayes being three, the nays being two. The motion to approve staff strapped. Notice a proposed rulemaking for a prohibition of children's toys and childcare articles containing specified phthalates and to publish the same in the Federal Register passes. We will now have closing statements. And before I begin mine, I want to talk briefly about the process going forward for staff because there's been a lot of discussion about what staff will do, won't do resources. I want to remind the staff that we do have a scientific integrity policy that was approved by the Commission a few years ago and I run a read from section six of that policy, quote, the work environment at the CPSC includes protection from inappropriate hindering or interference or the appearance thereof by anyone in the performance or activity of CPSC scientific and technical staff or in the design, implementation or interpretation of the scientific and technical work required to achieve the agency's mission, end quote. The point of reading that is I want staff to know, and of course it's not limited to this particular rulemaking. It applies of course whatever the agency is doing from a scientific or technical basis that if staff feels whether it's from me or my office or from anybody else that they're being put in a position of undue influence for the design of their work related to this, I would like to know that and they should of course report that immediately to anybody whether it's the IG or wherever they're most comfortable doing that. Now I'm going to turn to my statement. Many parents desperately want to know and all parents certainly deserve to know that their children's toys and childcare articles are not exposing them to harmful chemicals whether in isolation or cumulatively. Rational and thoughtful public policy in this area would involve the government and industry coming together to agree which chemicals are safe for human exposure, especially pregnant women and children and which ones certainly are not. And rational and thoughtful public policy would have these assessments occur before these chemicals are permitted to come onto the market. The FDA has pre-market approval of chemicals that we ingest intentionally. The CPSC has to wait to demonstrate toxicity and exposure to chemicals that we unintentionally ingest or otherwise exposed to. Some chemicals require pre-market approval by FDA before use, but not by us for consumer product use. I find that to be a totally irrational public policy. If studies on this topic prove accurate, one also has to wonder how much of the hundreds of billions of dollars the country spends on healthcare, education, and maybe even the criminal justice system could be more efficiently and effectively deployed if chemical exposure issues were addressed in a coherent fashion. I want to be clear that this is not to demonize the chemical industry. I get it, chemicals have and will continue to play an important role in societal advancements. This point is made nicely on the energy side by a video on ExxonMobil's website about boiling an egg and what actually goes into that from an energy standpoint. I would note if we were the FDA, we would point out to ExxonMobil that they missed a chance to educate consumers about salmonella exposure by not having the person wash their hands after she touched the egg. Like I said, I understand chemicals play a real role. This is not about having a problem with chemicals. It is about having a problem with no systematic approach to assess chemicals before there is potential for harmful exposure, especially for pregnant women and children. Short of the ideal of a more rational public policy, and we are well short of that ideal, the government would be organized and funded in a manner that even after the chemicals come on the market, the government could quickly make those assessments and act accordingly to protect public health as necessary. If we are going to tolerate a system where chemicals come on the market before we have a sense of their potential health effects, especially on vulnerable populations, it seems fair to expect the government to be equipped to move more quickly to make determinations on the safety of those chemicals and to have the authority to take action as warranted to protect us all. Sadly, I see a large and disconcerting gap between the scenarios I described and those that exist in reality. And to me, at least, this is nothing short of a flat out public policy failure. There appears to be no clear, systematic and holistic organization or plan to the way the federal agencies are tasked with studying the basic toxicity and exposure scenarios of chemicals. This lack of structure is probably unintentional, just a function of the way agencies are created over time and are managed. But there is also a severe lack of federal funding as well as authorities to quickly and comprehensively address chemical toxicity and exposure, and this is very intentional. So agencies such as the CPSC proceed in piecemeal fashion, driven in part by the professional judgments and interests of our scientists, in part by the direction that is set by interested leadership, especially the chairman at any given time, and in part by congressional mandate. That brings us to section 108 of the Consumer Product Safety Improvement Act, the reason we're here today and just to prove the NPR in front of us. When enacting CPSIA, Congress spoke with an unusual level of overwhelming bipartisan agreement, especially on something as substantive as what was included in that bill. The Senate passed the conference report by a vote of 89 to three. The House by an even more overwhelming number, 424 to one, those are some numbers, especially in today's political climate. Those numbers and the legislation they approve reflect clear public policy choices and direction. In section 108, Congress made at least three of those clear public policy choices. First, move the raging debate and let's not act like this was not already a raging debate back then, on phthalates and phthalate alternatives to a truly independent panel of the most respected scientists in the world for a report with recommendations on how to proceed to protect the public health, particularly of pregnant women and children. Second, when it comes to deciding on the three interim phthalate bans in particular, the commission is to quote unquote base the final report, final rule on the report of those experts. And third, move quickly, as evidenced by the requirement on the law to approve a final rule within six months of receipt of the report. Congress also made another important public policy decision, section 108. Even with the possibility that consumers are exposed to phthalates more from food packaging in the environment than from consumer products, Congress still required the panel of scientific experts to undertake a cumulative risk assessment. The truly independent scientific experts provided us with their report. That report included a cumulative risk assessment as they were charged to do. It also included public health driven recommendations on far more than just how to proceed regarding the interim bans as I made that point earlier. And their work and their conclusions were based on more than just certain sets of human biomonitoring data. In short, the independent scientific experts did the job Congress required them to do. Now it is incumbent upon us to do ours. We must continue to follow the requirements of section 108. I believe today's actions are entirely consistent with the law and any efforts to have moved away from the report of the truly independent scientific experts were to delay publishing this notice of proposed rulemaking would not have been. We need to get this rule published and out for comment. We need to follow the law and despite a broken chemicals management policy to the best we can to get answers regarding these chemicals. If they are truly safe or exposure is truly not a concern, great. If so, we should be prepared to say that and let industry and the public know. But if these chemicals are harmful and exposure is a concern, then we need to act responsibly and quickly to protect the public, especially pregnant women and children. I call on the commission to do this as the chairman and I implore the commission to do this as a parent and I'm gonna tell a brief story about what happened earlier this week. My wife took my younger son to the dentist. He's five years old. It's like taking a wild animal to the dentist. And when he came home and he had a bag, of course they give out bags with toothbrush, toothpaste and a gift. And I noticed quickly on the table there was this toy and my first instinct, of course, having worked at the CPSC was to seize this toy and to not allow him to touch the toy. Thankfully he hadn't seen it yet so that we did not have to engage in the tug of war but it really bothered me that I had to be concerned about this. It bothered me as a parent that I had a wonder about the safety of this toy, whether it's from chemical additives or whatever it is. And we had to go back the next day because he had an extreme cavity that needed to be addressed. And so we're there the next day and I watched another family walk out and they had one of those bags in their hand and the child was immediately grabbing for that toy and that bag. And I feel it's incumbent upon us to help those parents. They may not be thinking about that but they should know when they give that toy to a child it's a toy for a child. It's the last thing a parent should have to worry about being concerned about. And it's incumbent upon us, I believe as policy makers to do what we can to try to provide that certainty for parents. So the step the commission is taking today is a relatively small one but it isn't necessary. It is overdue and it's required by law. We are too small and have too few funds to solve the larger public policy failure. As long as I'm in this position though, I'm committed to positioning the agency to play as meaningful and effective a role as we can to bring some clarity to the issue of chemicals for both industry and for parents. They both deserve no less from us. Commissioner Adler. Thank you very much Mr. Chairman. And I agree with a lot of what you said and I also deplore the fact that we are faced in this country with the regulatory system that I think on occasion falls substantially short of protecting the public in the way that it should. The thing that always strikes me is that we are awash in chemicals. You cannot avoid chemicals, chemical manufacturers are therefore a vital part of our economy and I encourage them to continue to make new innovative products. But the fact is that because we are awash in chemicals and because at times it's just hard to pinpoint whether a particular chemical is causing a hazard or whether in combination with other chemicals it makes the inquiry challenging. I don't believe the onus should be entirely on the government to establish that products are unsafe. I think that industry and the government should share in that undertaking. I remember back to the early 60s when Thalidomide was causing terrible, terrible birth defects in children and the FDA came within a hair spread of approving it because there was still a time lag between when you ingested it and when the effects were felt in a child. And that's the nightmare I think that we all have. But the problem is for so many chemicals that present a toxic risk it's not that clear, it's not that easily identifiable. And so it really is a major challenge for all agencies and for the government and for our friends in industry to work together to address these risks. I would love to see Tosca amended to be a more updated and a more protective piece of legislation. Frankly, I'm not holding my breath. I also wish that this agency had the capability to do the kind of basic research in addressing these kinds of hazards. We don't. We have tremendous toxicologists. But what we are basically stuck with is looking to the research that's done by other agencies like EPA or other organizations like the National Toxicology Program to do those initial assessments and then for us to act as we see these hazards emerge. I think that what we see in section 108 is a great approach to addressing a specific set of chemicals and to the extent that future issues like this arise I would love to see additional approaches using the guidance that's found in section 108. Again, cannot thank the staff enough for a truly outstanding job and tell you how much I appreciate it. Commissioner Robinson. I'm very gratified that we've passed this NPR today and are one step closer to addressing the serious health risks to fetuses, babies and infants from phthalates. I wanna thank Congress. I am delighted that they passed this groundbreaking law to get this process started. I thanked the chat, but again, just this report was just excellent. And I think the very fact that they sought peer review of their final report tells us volumes about how carefully they were trying to get it right. And our staff, I'd like to not only thank you for all of your assistance during this educational process for me and my staff, but for the obviously months that went into preparing this package, but also the years that you spent working with the chat to come up with this final result. We have much work ahead of us as we enter the notice and comments stage and I'm relying on our stakeholders to invest their resources in providing comments to us. What's been proposed in this NPR is that five phthalates that are known to be anti-androgenic be banned. And we've proposed lifting, or the staff has proposed lifting the interim ban on two phthalates that have not been found to have anti-androgenic effects. And we have not proposed taking any further regulatory action regarding a number of other phthalates and phthalate alternatives. The DIOP has already been discussed and I won't discuss it further. But I would just like to point out, as has been pointed out by others and by me as a matter of fact, that this is only the first of a small step in what must be a larger and broader effort to address these hazards. We regulate only a small fraction of the products for a small part of our population. And as CHAP and our staff have noted, food and cosmetics are the largest contributors to exposures to the phthalates of concern. And although the CHAP and we are only proposing bans based on anti-androgenic effects of certain phthalates, we certainly know that the medical research has shown that some phthalates have serious toxic and carcinogenic effects in various species. We know that some phthalates are associated with very troubling health and developmental issues in humans such as cancer, liver toxicity, behavioral issues such as ADHD and reduced IQ. The research in these areas is growing all the time. We're also learning more about our exposures to these phthalates, which are ubiquitous. The CHAP report also contained a call to the CPSC on the sister agencies and my fellow commissioners and I have also asked sister agencies to get involved to continue the studies of these chemicals. I'm just hopeful that somehow we're gonna find a way to work through an interagency effort to find real life practical solutions to deal with the issues as Chairman Kay spelled out. For example, the CPSC has been involved with NIH's National Toxicology Program. I know they have a board of scientists that advises them and I'm just hopeful as we start this next phase of working through these issues that maybe we'll find a way to work in an interagency effort to address the hazardous chemicals in our consumer products. So again, I know I'm thanking you many times but I can't thank you enough for all the effort that went into this and I think all of us should be very proud of the effort that's gone into what we've done today and of what we have done. Thank you. Commissioner Birkel. Thank you, Mr. Chair and I wanna echo my colleagues. Thanks and appreciation to all of the staff for putting together this package and for all of the work that's gone into this. Unfortunately, I can't share in the enthusiasm that we're gonna proceed to rulemaking on phthalates today. We often say that we are a data-driven agency but this decision calls our commitment into question. The CHAP's cumulative risk assessment is the cornerstone of their work. Their recommendations for banning phthalates were all based on the cumulative risk assessment but those recommendations were based on obsolete data, not the likely exposures required by section 108 of the Consumer Product Safety Improvement Act which we refer to as the CPSIA. The CHAP used exposure estimates based on 0506 and earlier data. The Centers for Disease Control released new exposure data every two years. The 0708 data was released just a few months after the CHAP's second meeting. The 0910 data was released in September of 2012, well before the December 31st, 2012 cutoff, chosen by the CHAP and more than 18 months before the CHAP's report was actually delivered to the commission. Why does this matter? And I know I've been beating this drum since this whole discussion began. Why does this matter and why am I taking this so seriously? What really drives the cumulative risk assessment is the high exposure to DEHP which is by far the most potent of the five phthalates included in the cumulative risk assessment. DEHP was banned by Congress in toys and childcare products in August of 2008. While exposures from toys were, and we've heard this this morning, were only a small fraction of the overall exposure to DEHP, particularly for adult women, the ban on DEHP and toys prompted a broader market reaction. Manufacturers started to replace DEHP and other products as well. So exposure to DEHP started to drop significantly. The exposure estimates from 05 and 06 data cannot possibly reflect post-CPSIA exposure levels to DEHP. To me, and I've said this publicly, this would seem to me a very important and relevant information to have a DEHP, which was such a dominant factor in the cumulative risk assessment to have that number reflect the current status. The more recent 09, 10 and 11, 12 NHANES would have provided a more up-to-date analysis. Using more recent data is essential, especially given that we all know that the scientists out there have already done the same calculation that the CHAP did, but with more recent data exposure. They found that if the CHAP had used the 09, 10 NHANES data, the most recent available to them prior to the deadline of December, 2012, it would have completely changed their results. The so-called hazard index falls below the action level. No need to ban more phthalates, no need to continue the interim prohibition on DINP, much less expand it to a larger group of toys. What we've talked about today is, and I think is so important, is we don't need to take the outside scientist's word for it. Our staff has the expertise to do these calculations. Our staff has access to all of the data that other scientists had, and probably better access to the CHAP's methodology and models. And while I am pleased that the staff will conduct such an analysis during the comment period, I really do think it should have been done prior to today's NPR. I hope staff will make their revised analysis available to the public well before the end of the public comment period. Has the CPSC ever knowingly proposed a regulation that is based on data this far out of date? I doubt it. Usually we uptake our most important data analysis every year. We do an annual report for ATVs and for fireworks, for nursery products, and for toys. If we are proposing a mandatory standard, we usually do an extra analysis of deaths and injuries using the latest available data. Can anyone here in this room imagine us proposing a new standard for ATV or for toys based solely on injury data that's eight or nine years old? I know, and we've talked about it this morning, that Congress has imposed a tight timeline for our rulemaking, and doing the analysis of this more current data prior to rulemaking would impede the ability of the CPSC to meet that mark. We should always respect congressional deadlines as much as we possibly can. In this instance, however, Congress also said that the CHAP should consider likely exposures and the most recent, best available scientific data. The CHAP failed to do that, and so it is up to us to examine the impact of using the more recent exposure data. And I want to make this clear. My concern over the data used by the CHAP is merely a threshold issue for me. I have other concerns as well. I'm disappointed that the CHAP did not invite public comment on their draft report, but only a narrow private peer reviewed. Not only did this decision deny the stakeholders an opportunity to engage on the issues, it slowed the report process down significantly. While there's no explicit CPSI requirement for public peer review, it is a common and highly appropriate process for such a highly influential technical and scientific document to undergo public peer review. CHAP's independence notwithstanding, an open peer review would have allowed public comments to be reviewed and analyzed prior to the rulemaking, giving our staff all of the relevant feedback prior to their own assessment of the CHAP's report and recommendations. Beyond this, I have questions about the proper legal standard for expanding the scope of an interim ban from mouthable toys to all children's toys. I'm not convinced that all of the animal studies reviewed by the CHAP are applicable to humans. I question the idea of banning chemicals based on a cumulative risk assessment to which they contribute little or no risk. I am troubled by the idea of banning the use of chemicals in toys when the exposure from toys are dwarfed by the exposures in food, cosmetics, and other sources outside of our jurisdiction. And I am greatly concerned that we are considering banning chemicals that have been in use for many years and whose risk have been studied for a long time, when we know very little about the alternatives that may be used instead. The bottom line is this. There is a lot we don't know, a lot, perhaps, that could have been answered by public peer review and or a data analysis prior to issuing the NPR. We must analyze the more current data and we must review input from a lot of the stakeholders. And when we do, the staff's recommendation may change. Maybe the staff will see different reasons why we will still continue the ban on some of these fallowites. Maybe their recommendations will be reversed. I do not know what the outcome will be. But what I do know is that in order to get this right, we must use the right data. Thank you, Mr. Chair. Thank you, Commissioner Berkel, Commissioner Mohorovic. Thank you, Mr. Chairman. Mr. Chairman, I'm first completely thrown off by your comments. I thought I was prepared for my closing remarks, but when you mentioned having worked at the CPSC, upon seeing a toy, your first instinct was to seize it. I got a little bit thrown off by that. That's not my first instinct upon seeing a toy to jump to try to seize it. But I do want to echo the thanks to all the staff and especially to Dr. Babbage today for running that scene and a few good men between Nicholson and Cruz, where, you know, trying to find out who ordered the Code Red. But, you know, I failed to be able to get you to identify specifically who ordered the Code Red, such that the data set not be run to inform our decision-making here. I'm also moved by the complaints we've heard about our U.S. regulatory system with approach to chemical management. And we've heard eloquently the defense of the European approach. We've heard not by definition or by definition, but not by name, we've heard the precautionary principle. We've heard how the precautionary principle is the right approach. And perhaps there are those that wish the precautionary principle was also the baseline of administrative law and regulatory procedures here in the United States. Those, that same foundation that led the European Commission and the Union to come up with the Reach and Rose regulations. But I would also like to point out that in looking at and observing the T-TIP negotiations and those of the regulatory working group, we would be out of step with the President of the United States and specifically with USTR in how they work to confront and thwart the European direction to promote the precautionary principle globally, although it certainly seems to have a very good foothold at the Consumer Product Safety Commission. There's been a lot of talk about data-driven. I've mentioned it before. Are we data-driven? We all like to be data-driven. In this case, are we not being data-driven? And I don't disagree that the recommendations to move forward with this regulation is data-driven. I would only point out that we're driven by data which is outmoded, ineffective, and insufficient. Thank you, Mr. Chairman. Thank you, Commissioner Mohorovic. Thank you, commissioners to the staff, particularly Dr. Carlson, Dr. Babich, and Mr. DiMiteo. Those are either in attendance or have watched on the webcast. This concludes this public meeting of the US Consumer Product Safety Commission.