 Good morning, Mr. Chairman and commissioners. Good morning, Dr. Babich. You just got to give me a second, please, to start the meeting if that's okay. I know you're eager. We're all very eager. We're under tight congressional deadlines, and Dr. Babich is ready to get us moving along. Good morning, and welcome to this public meeting of the United States Consumer Product Safety Commission. We have one item on the agenda this morning. CPSC staff will brief the commission on a notice of proposed rulemaking for a prohibition of children's toys and childcare articles containing specified phthalates. The CPSC staff members briefing us this morning are Dr. Michael Babich, director of the division of toxicology and risk assessment and directorate for health sciences, office of hazard identification and reduction, Dr. Kent Carlson, toxicologist, directorate for health sciences and the office of hazard identification and reduction and Mr. David Demiteo, attorney in the office of the general council. At the conclusion of staff's briefing, we will turn to questions from the commissioners. We're gonna start with the staff briefing and whether it's Dr. Babich or Mr. Demiteo, if you could please begin. I will like to ask Mr. David Demiteo to begin the briefing to talk about the CPSIA. Good morning, chairman and commissioners. I will be giving a brief overview of the law. Section one of the CPSIA permanently prohibits any children's toy or childcare article that contains concentrations of more than 0.1% of and bear with me for just using the acronyms here, DBP, BBP and DEHP. Section 108 also on an interim basis prohibits any children's toy that can be placed in a child's mouth or childcare article that contains concentrations of more than 0.1% of DINP, DIDP and DNOP. The statutory prohibitions became effective February of 2009. And the interim prohibitions remain in effect until the commission issues a final rule determining whether to make the interim prohibitions permanent. Section 108B2A requires the commission to appoint a chronic hazard advisory panel, also known as a CHAP, to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and childcare articles. And Dr. Babich will be discussing in a moment in more detail the CHAP charge. Section 108B2C directs the CHAP to recommend to the commission whether any phthalates or phthalate alternatives, other than those permanent probate, it should be declared band hazard as substances. Regarding rulemaking, Section 108B3 of the CPSIA requires the commission to promulgate a final rule under Section 553 of the Administrative Procedure Act, also known as the APA, not later than 180 days after the commission receives the CHAP report. Section 108B3A requires the commission to determine, based on such report, whether to continue in effect the interim prohibition in order to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety. Section 108B3B also requires the commission to evaluate the findings and recommendations of the CHAP and declare any children's product containing any phthalates to be a band hazardous product under Section 8 of the CPSIA, also known as Consumer Product Safety Act, as the commission determines necessary to protect the health of children. And now at this point I will turn over the rest of the presentation to Dr. Babbage to discuss the CHAP report and proposed rule. Good morning. Phthalate esters or phthalates or more properly orthothalate esters are a family of chemicals that are mainly used as plasticizers, softeners for vinyl plastics. They're also used as plasticizers in other plastics as solvents and in fragrances. Phthalates have been used in many types of products, including tethers, toys, automobiles, personal care products, and medical devices. The CPSIA required the CHAP to assess the potential health risks of phthalates used in children's products, including all potential health effects on children's health, including endocrine disruption, effects of phthalates, both in isolation and in combination with other phthalates, likely levels of exposures to children, pregnant women, and others, cumulative effect of total exposure to phthalates from children's products, personal care products, and other sources. And the CHAP, in doing so, the CHAP is to review all relevant data, consider health effects not only from ingestion, but also as a result of dermal hand-to-mouth or other exposure, and consider the level at which there is a reasonable certainty of no harm using appropriate safety factors for children, pregnant women, other susceptible individuals in their offspring, and consider possible similar health effects of phthalate alternatives used in children's toys and childcare articles. The panel's examination is to be conducted de novo, and finally, they're to recommend to CPSC whether to ban any additional phthalates or phthalate alternatives or combinations thereof. In short, it's a tall order. The staff is grateful to the CHAP members shown here for their professionalism and dedication in completing their lengthy and complex task. The CHAP met for the first time in April 2010, and in a total of seven public meetings. At the July 2010 meeting, the CHAP heard public testimony from stakeholders as well as federal agency representatives. They also invited distinguished scientists to present their latest research at that meeting and several meetings thereafter. During the course of their work, the CHAP requested peer review of their draft report. Peer reviewers were nominated by the National Academy of Sciences and met the same conflict of interest requirements as the CHAP members. In other words, they don't work for the government except NIH National Toxicology Program or the National Center for Toxicological Research, and they aren't associated with the manufacturers. And the process was managed by a not-profit group specializing in peer review, and the requirements to have them, they were based, the peer reviewers were held to the same requirements as the CHAP members to protect the independence of the CHAP report. So, to summarize the CHAP report and its findings, as required by the CPSIA, the CHAP considered health effects of phthalates in animals, all health effects of phthalates, and there are a number of potential effects that they considered, liver and kidney toxicity are the most common targets across the range of phthalates. Carcinogenicity is less common, not as many phthalates are associated with carcinogenic effects. These are mainly epaticellular tumors caused by associated with DINP and DEHP. However, the mode of action which involves something called PPA or alpha induction doesn't or may not be relevant to humans, and this is something that a previous CHAP addressed. There are also various types of reproductive and developmental effects, skeletal variations, urinary tract malformations, reduced fertility, and finally, certain types of effects on male reproductive development known as the phthalate syndrome. After considering all the health effects of phthalates, the CHAP decided for the purpose of the cumulative risk assessment because they're looking at both cumulative risks and risks in isolation, for the cumulative risk, they would focus on the male developmental effects for assessing the cumulative risk. Now, phthalate syndrome in rat is a set of symptoms, effects, that includes, among others, reduced analgenital distance, retained areola nipples, which does not normally happen in the rodents. Undescended testes, oh, typo, undescended testes in a malformation of the penis called hypospadius. Now these effects are due in large part to inhibition of testosterone synthesis. Another word for that would be antiandrogenicity, which the CHAP often uses in their report. And based on the animal's data, the fetus is the most sensitive target, the most sensitive life stage to these effects, followed by the young animals and the adult. So, for example, at a later age, you may need higher doses to see an effect. The CHAP concluded that this is overall the most sensitive and most studied endpoint. They also noted that mixtures of antiandrogenic phthalates, well, not all phthalates cause this effect. There are certain ones that do. And they're called either active phthalates or antiandrogenic phthalates. And mixtures of antiandrogenic phthalates and even other antiandrogenic compounds are additive. In other words, there's evidence from the animal studies that there are indeed cumulative effects. The CHAP also reviewed the human data on phthalates. And they noted that phthalate syndrome in animals resembles something called testicular disgenesis syndrome in humans. This is characterized by undescended testes, the same malformation of the penis, the hypospadius, poor sperm quality and testicular cancer. Most of these are the same effects produced by the phthalates in the animals. And they also noted that there is a growing number of studies associating phthalate exposure in humans with reduced antigenital distance in newborns, cognitive and behavioral effects in children, and reproductive effects in adult males. Now, the epidemiology studies by their nature have limitations for one thing, you can't control a person's exposure. You can't test one phthalate at a time and then put them all together. So they don't, it's difficult to establish a cause and effect from epidemia in general. However, in the staff's view, this provides supporting evidence for the animal studies, the fact that you have consistent results across multiple species, and evidence that similar effects occur in humans is a powerful combination. To us, there are actually, well, two ways. The CHAP assessed exposure to phthalates by two different methods. Human biomonitoring, the first method involves measurements of phthalate metabolites in human urine. It provides measures of a person's total exposure to a number of phthalates. We sometimes refer to it as a top-down approach. However, it does not provide information on the sources of exposure. In data for biomonitoring data, in the CHAP report came from two sources. The NHANES, the National Health and Nutrition Examination Survey, is a national survey conducted periodically by the Centers for Disease Control and Prevention. It includes a statistical sample of the U.S. population. And the biomonitoring data on phthalates and other chemicals are part of a much broader study. The CHAP used NHANES data to estimate exposure for pregnant women and women of reproductive age. However, NHANES doesn't include children under six. So the CHAP obtained additional data from an NIH and EPA-funded study called the Study for Future Families. This study has biomonitoring data on mother-infant pairs. The mothers are studied during pregnancy and after delivery in, of course, the infants after birth. The CHAP also estimated exposure from specific products and sources by exposure modeling. This is another requirement of the CPSIA. It uses data on phthalate concentrations in products, migration rates, and use patterns to estimate exposure. For example, to estimate exposure from malving toys. The CHAP used the migration rate of phthalates into artificial saliva, combined with data on malving duration, you know, how long does a child mouth toys and teeters and things like that. This provides exposure estimates for specific sources like personal care products as required by the CPSIA. And we look at this as a bottom-up approach. The CHAP's overall plan for the cumulative risk assessment involved the hazard index approach based on effects, based on effects on male reproductive development. The dose response assessment, in other words, the potency estimate for the phthalates was based on animal studies. Exposure for the cumulative risk assessment was based on estimated from the biomonitoring data. Based on the animal studies, the most sensitive target is the male fetus followed by newborns, juveniles, and adults. Thus, the CHAP considered exposures to pregnant women, which is really a surrogate for the fetus. They also looked at mothers, prenatal, and postnatal, and infants. The CHAP used something called the potency estimate for anti-androgenicity as a measure of potency. The PEAA is, it's similar to an acceptable daily intake or a reference dose that many we and other agencies derive, except that it's specific for this particular male reproductive effect. Normally, a reference dose or acceptable daily intake is based on whatever the most sensitive effect is for a particular chemical. In this case, it's specific to the endpoint. And to do this, CHAP used three different, actually used three different sets of PEAA values, they called them cases, to assess the effect of different PEAA values on the overall conclusions. Each case includes a PEA value for each phthalate. Case one uses values from a recent publication, published values. Case two is based on a relative potency approach, using data from a single laboratory where all of the phthalates were studied under identical conditions. In case three is based on the CHAP's literature review, in other words, the breadth of the literature on phthalates. Now to calculate the hazard index, for each individual in the NHANES and the SFF study, you calculate, you have the metabolite levels in the person's urine, you calculate that's used to calculate the exposure to each phthalate. The hazard quotient for each phthalate is the exposure divided by the PEAA value. And then the hazard quotients are simply added to obtain the hazard index. A hazard index greater than one means that there may be a risk for effects on male reproductive development. The CHAP found that up to 10% of pregnant women and up to 5% of infants have a hazard index greater than one. Thus, up to 10% of pregnant women, actually there may a loss spring and up to 5% of infants may be at risk for the male reproductive effects of phthalates. The hazard index method also shows how much each phthalate contributes to the hazard index. For pregnant women, DEHB clearly contributed the most to the overall hazard index. These are the five phthalates that were included in the cumulative risk assessment and the results from the three different cases. Dibutal phthalate, the starred ones, dibutal, butyl, benzal, and DEHP are permanently banned phthalates. DINP at the bottom is subject to the interim ban. Diasobutal phthalate is another phthalate that the CHAP has recommended for prohibition. And so what this shows is that most of the risk, most of the hazard index comes from one phthalate, DEHP, in that the other phthalates contribute about equally to the overall risk. The exact amount varies by the case, but it's between one and 8%. And this is simply a similar graph for the infants. In this case, DEHP is still the predominant contributor to the overall risk. The other phthalates contribute a little bit more in this case, up to 15%. So the CHAP's key findings from the hazard index. For pregnant women, up to 10% have a hazard index greater than one. And male fetuses, their male fetuses may be at risk for adverse health effects. For infants, up to 5% have a hazard index greater than one and they may be at risk for the cumulative effects of phthalates in that the hazard index is primarily due to one phthalate with cases one and three, about 75% of the overall risk or more than 75%, case two, more than 50%. So the CHAP also considered how different sources of exposure, different products, can contribute to the total exposure. This was done by exposure modeling. The CHAP's analysis assumed that phthalates would be allowed in toys and childcare articles. What if they were allowed and actually assumes that all the products have PVC products anyway or actually contain phthalates. Again, for women of reproductive age, diet was the major source of exposure for most of the phthalates, diet meaning food and beverages and so on. Cosmetics and personal care products are also significant sources of diethyl phthalate and dibutyl phthalate, two particular phthalates. Diethyl, by the way, is not one of the anti-androgenic phthalates, so it's not contributing to the cumulative risk assessment. For infants and toddlers, again, most of the exposure is from diet. Personal care products are a major source of diethyl phthalate, but that's a different category. Teethers and toys and childcare articles also contribute significantly to the overall risk, but really the vast majority is from diet. And, of course, as required by the CPSIA, the CHAP also considered risks in isolation, and this was done largely by the margin of exposure approach. And the risks in isolation, unlike the cumulative risk, are based on the most sensitive endpoint for each chemical. And it's not necessarily the male developmental effects. In fact, for the, it's not that if the chemical is not causing those effects. The margin of exposure is the ratio of the no observed adverse effect level, or no L or no AL, to the exposure. In other words, you divide the no effect level by the estimated exposure. In this case, a larger margin of exposure means a lower risk. For most chemicals, you would like to have a margin of exposure of at least 100 to protect human health. This assumes, well, in the most common case, you have established a no effect level in animal studies. In other cases, if you have not established a no L or there are some, if you have inadequate data, you might want to see a margin of exposure more like 1,000. So the CHAPS recommendations, in making the recommendations, they use this scheme for the anti-androgenic phthalates. Their recommendations were based on male developmental effects, and they placed greater emphasis on the cumulative risk than the risk in isolation. For non-anti-androgenic phthalates, in the phthalate alternatives, essentially the alternatives weren't anti-androgenic, they used the most sensitive endpoint, and of course, and they assessed the risk in isolation. The CHAPS did not recommend anti-androgenics in any further action by CPSC, at least not any further prohibitions on the permanently prohibited phthalates. Obviously, they're already permanently prohibited in children's toys and childcare articles. Although they did make some general recommendations on additional work by the federal agencies as a whole. Regarding phthalate subject to the interim prohibition, the CHAP recommended a permanent prohibition of toys and childcare articles containing disinun phthalate because it's anti-androgenic and therefore it contributes to the cumulative risk. The CHAP also recommended removing the interim prohibition on dienoctyl phthalate and diisodesyl phthalate. There's no evidence of anti-androgenicity, therefore they considered the risks in isolation and the margins of exposure were greater than 100. The CHAP also made recommendations on some phthalates that are not currently subject to prohibition. The CHAP recommends a permanent prohibition of children's toys and childcare articles containing diisobutyl phthalate, dienpentyl phthalate, dicyclohexyl phthalate and dienhexyl phthalate. These are anti-androgenic and they contribute to the cumulative risk. And also the CHAP recommended an interim prohibition of diiso-octyl phthalate because there's limited evidence of anti-androgenicity and the CHAP reviewed a total of 14 different phthalates. They did not recommend any CPSC action on dimethyl phthalate, diethyl phthalate, or di-2-propyl heptyl phthalate because there's no evidence of anti-androgenicity. However, and there's no evidence that they present a hazard, pose a hazard to consumers. However, they did recommend additional study of diethyl phthalate and DPHP by the federal agencies, appropriate federal agencies and they did note that there are limited data available, at least publicly available on the health effects of DPHP. And DPHP is one that we hadn't seen in toys, but it did show up after the CHAP report was completed so we have seen it now. And finally, the CHAP looked at six phthalate alternatives. Again, they're not recommending any action on these alternatives at this time, in part because there's no evidence of anti-androgenicity and there's no evidence that they're pose a hazard. However, they noted that there are four various chemicals or some of these are limited in terms of either their toxicity data or exposure data or both. So again, the CHAP recommended these for further study by the appropriate federal agencies. Some of these substitute the alternatives like the phthalates are multi-use chemicals and they're found in a lot of products and found in our homes. And for some of these, the CHAP was able to estimate exposures from toys and childcare articles, but the total exposure to these chemicals which includes food for some of them is unknown. So the staff review the CHAP report and concluded. The CHAP fully met its charge. The selection of phthalates and phthalate alternatives for study, for inclusion in their report is appropriate. They selected phthalates and alternatives that were either the six phthalates in the CPSIA and they added additional phthalates and alternatives based on either known toxicity or known exposure or exposure potential. The selection of the health endpoint for the cumulative risk assessment is appropriate and the CHAP used appropriate methodology such as human biomonitoring, the hazard index and the margin of exposure. The selection of the health effect for cumulative risk assessment effects on male reproductive development was appropriate because it's associated with many of the most common phthalates. It's often the most sensitive effect. In other words, it's the effect that occurs at the lowest doses. It resembles testicular dysgenesis syndrome in humans. It's a well-studied endpoint. There's evidence of additivity that is cumulative effects and this is not true for most of the other phthalate endpoints. Effects on male reproductive development have been observed in multiple mammalian species. And this is the endpoint that was recommended by the National Research Council wrote a report on essentially how to go about assessing the cumulative risk of phthalates. This was done for the EPA and this was the endpoint that the National Research Council recommended that they focused on and it's also the endpoint that has been used by other authors who have studied the cumulative risks of phthalates. And finally, similar effects are observed in the epidemiological studies. This provides supporting evidence for the human relevance of the animal studies. So this endpoint likely is relevant to humans. Now, the CHAP selected the hazard index approach precisely because it was widely accepted for cumulative risk assessment. Their selection is consistent with the recommendation of an NRC report on phthalates prepared for the EPA, the same one I just mentioned. The hazard index approach was used by other authors for cumulative risk assessments of phthalates. In applying the hazard index method, the CHAP appropriately accounted for the fact that different individuals are exposed to phthalates in different proportions. Failure to consider this such as by using only average exposures would lead to overestimation of the 95th percentile exposure and hazard index. So finally, the staff considered the CHAP's recommendations and developed our recommendations to the commission. For phthalates subject to the interim prohibition, the commission, the CPSIA requires the commission to determine whether a permanent prohibition is needed to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety. For the anti-androgenic or active phthalates, the staff's recommendation is based on the cumulative risk. And the staff considers that a hazard index less than one is needed to ensure a reasonable certainty of no harm. For the non-anti-androgenic phthalates, the staff recommendation is based on the risk and isolation and the staff considers that a margin of exposure greater than 100 is needed to assure a reasonable certainty of no harm to children, pregnant women, and so on. And regarding di-inactyl phthalate and iso-deseal phthalate, the CHAP recommended that the commission lift the interim prohibition on DNOP and DIDP. These are not anti-androgenic. They do not contribute to the cumulative risk. The margins of exposure are adequate, well over 100 considered in isolation. And the staff concludes that a prohibition of these phthalates is not necessary to ensure a reasonable certainty of no harm to pregnant women, children, and so on. Therefore, the staff recommendation is to not continue the interim prohibition for DNOP and DIDP. The CHAP also recommends a permanent prohibition of dinp use in children's toys and childcare articles. The staff recognizes that if we were only exposed to dinp in isolation, that it would not present a hazard. We also recognize that diet is the major source of exposure to dinp and that dinp is slightly less potent than the other anti-androgenic phthalates. However, dinp does cause adverse effects on male reproductive development as demonstrated in multiple studies. Up to 10% of pregnant women and up to 5% of infants have a hazard index greater than one. Allowing the use of dinp in toys and childcare articles would increase the cumulative risk from phthalates. Thus, the prohibition is necessary to ensure a reasonable certainty of no harm to pregnant women, infants, actually the fetuses, and so on with an adequate margin of safety. The staff's recommendation is a permanent prohibition of children's toys and childcare articles containing more than 0.1% dinp. The CPSIA also requires for phthalates not subject to prohibition. The CPSIA requires the commission to determine whether additional prohibitions are necessary to protect the health of children. The CHAP recommends permanent prohibition on the use in children's toys and childcare articles of four additional phthalates associated with effects on male reproductive development. These are diisobutyl phthalate, dienpentyl phthalate, dienhexyl phthalate, and dicyclohexyl phthalate. The staff recommendation is based on the cumulative risk and the staff considers that a hazard index of less than one is needed to protect the health of children. Regarding the permanent prohibition of these four phthalates, the staff recognizes that current exposures to these four are low. If we were only exposed to these in isolation, none of these four would pose a hazard in and of themselves. However, these phthalates are associated with effects on male reproductive development and they do contribute to the cumulative risk. Up to 10% of pregnant women and up to 5% of infants have a hazard index greater than one. Allowing the use of these phthalates in children's toys and childcare articles would increase the cumulative risk from phthalates. Therefore, the staff concludes that prohibition of children's toys and childcare articles containing more than 1% of either of these three phthalates is necessary to protect the health of children. We also note that diapental phthalate is the most potent of the anti-androgenic phthalates. Isobutyl phthalate is similar in potency to dibutyl phthalate which is one of the permanently banned ones and we are seeing it in some toys. Therefore, the staff recommends a permanent prohibition of children's toys and childcare articles containing more than 1% of these four phthalates. The CHAP also recommended an interim prohibition of diisoctyl phthalate. The CPSIA did not provide for interim prohibitions. The chemical structure of diop suggests that it may cause effects on male reproductive development. Thus, it might contribute to the cumulative risk. However, there are inadequate data demonstrating that such a hazard actually exists. And diop is not currently used in children's toys for childcare articles. At least we haven't seen it in our testing. So our recommendation is to reevaluate the risk from diop when additional data become available. The CPSIA set a limit of 0.1% for the regulated phthalates. Now this is not a risk-based limit. The purpose of this limit is to prevent intentional phthalate use. But it allows incidental contamination. The commission could set a different limit if warranted. The staff recommendation is that there is no risk-based justification for changing the limit and there's not enough information from the CHAP report to set such a limit. Therefore, we recommend maintaining the 0.1% limit for all prohibited phthalates. The CPSIA also requires the commission to determine whether to extend the phthalate prohibitions to all children's products if this is necessary to protect the health of children. At this time, there are sufficient information to assess the effects of expanding the scope to all children's products. However, limited information suggests that increased exposure from expanding the scope would be negligible. Expanding the scope would include many products, for example, ordinary wearing apparel, that are much less likely to contain phthalates. The product use patterns of other children's products outside of toys and childcare articles suggests a lower potential for exposures compared to children's toys and childcare articles. The staff concludes that there is no scientific justification for expanding the scope. The recommendations that the staff has presented would not change the number of small entities to which the phthalate restrictions apply. It's the same products. The consequences of four additional prohibited phthalates could mean that a small number of products containing diastributal phthalate would require reformulation. In other words, DIBP is not commonly found. The expected effect on testing costs for the additional phthalates is small or negligible because it's essentially the same test. The test doesn't change much. The same test, the same process is used to test all the phthalates. A permanent prohibition of, the effects of a permanent prohibition of DINP could mean that a small number of non-moutable toys that would require reformulation. And also, because currently the DINP prohibition only applies to childcare articles and toys that can be placed in a child's mouth, and as opposed to all children's toys, and that rarely, it's rarely an issue. I mean, they usually either have the phthalate or they don't. And again, there's no effect on testing costs because the testing's already required. If the commission issues a final rule, a small number of toys in childcare articles may require reformulation to remove diisobutyl phthalate. A small number of toys too large to be placed in a child's mouth may require reformulation to remove DINP. Testing labs would need to prepare to test for additional phthalates, although the test procedure remains essentially the same. Therefore, the staff recommends an effective date of 180 days following publication of a final rule. The conclusions, the staff recommends publishing the draft notice of proposed rulemaking, which includes a permanent prohibition of children's toys and childcare articles containing more than 1% of DINP in four additional phthalates. The staff expects that the NPR, the rule, if it goes into effect would not have a significant economic impact on a substantial number of small entities. The staff recommends an effective date of 180 days following publication of a final rule, and the staff does not recommend expanding the scope to include all children's products. Well, thank you for bearing through that explanation considering the report is very long and very detailed and very nuanced, and this is the distilled down version. The chat members were worried that it would be too long. Thank you, Dr. Babich, and I would note that that copy that you held up is double-sided, I believe, too, to reinforce that point. Thank you, Dr. Babich. Thank you, Mr. D. Mateo. We're now gonna move to the portion of this briefing where the commissioners get to ask questions. We're gonna go, as we always do, 10 minutes per commissioner, and we'll go as many rounds as we need for legitimate questions. Before the questions begin, though, I do wanna make a process point. There are a number of unique statutory provisions associated with this rulemaking. Some of the questions and the answers, in particular, might touch upon legal aspects or legal interpretations associated with those provisions, and so I'd ask the panel to give our general counsel a chance if she needs to jump in to make sure that we're not getting into areas of legal interpretation that should not be discussed in public. So on to questions. Since the issuance of the report, we've had a number of requests for meetings. My office held a number of meetings along with the office of the executive director and her staff. I know that we had a meeting, at least, with the American Chemistry Council. We had a meeting with folks from ExxonMobil, Breast Cancer Fund, BASF. Those groups have made a number of submissions, including from the American Chemistry Council, an independent expert peer review of the final CHAP report on phthalates and phthalates alternatives. My office and I have reviewed that. We've reviewed all the submissions that have been submitted by all the different groups, and one of the themes, and by the way, those meetings were open to the public and CPSC staff, including Dr. Babich and Mr. D. Mateo were present via digital video conferencing for those meetings. One of the central themes, Dr. Babich, is the NHANES data, and in particular, the fact that the CHAP relied on the 0506 set of NHANES data, and I understand that they had to make a cut-off, and that was the most recent information available to the CHAP at the time, but once staff obtained the CHAP report and staff was aware of at least three more sets of data that were more recent from the version that the CHAP considered, why did staff not consider the more recent NHANES data as part of the briefing package for this draft NPR? The NHANES has been collecting data on phthalate exposures since about 2000, and those exposure levels have stayed fairly constant through most of that time. It was only in the latest release of NHANES data which happened as the CHAP was literally dotting the eyes and crossing the T's of their report, and that what those, that the latest data showed was finally some small changes or some changes in the exposure patterns where some anti-androgenic phthalates went down and other anti-androgenic phthalates went up, and it's, but given the magnitude in the up and down nature of these changes, it was not immediately obvious as to whether or how these would affect the overall risk, and of course we were aware of this and we discussed whether it would be appropriate for the staff to do some analysis on these numbers and the answer is that the CPSIA required us to convene a CHAP to assess the risks, the potential risk from phthalates and that the rulemaking process would be based on the CHAP report, so it was just decided that any additional work by the staff would be deferred until the public comment period. Okay, so should the commission end up approving the issuance of this NPR, I do plan to direct staff to make sure that as part of any final briefing package that staff does include its views of the new NHANES data in that package. Commissioner Adler. Thank you, Mr. Chairman, and thank you for asking one of my questions in a much more thoughtful and articulate way than I would be able to ask it. And I do really want to thank the staff for the quality of the presentation and the quality of the briefing package and the quality of the legal memoranda. In all the years I've been following the commission, this is probably the most complex and nuanced report and set of issues, health issues for us to assess and I'm just grateful for the terrific work by staff and I also want to thank all of the stakeholders, the industry stakeholders, the health groups, stakeholders, the advocacy groups. I know they took a lot of time to come and present to us and they were trying to explain to non-scientists very, very detailed scientific studies so I really do want to express my appreciation. So I thought I'd start off by asking a very easy question but it's one I still am not clear about and that is the CHAP report says that phthalates like DINP present their maximum exposure to infants and toddlers through food, not toys. So how do phthalates get into food? That's a very good question and the obvious answer is that there are phthalates, they are allowed for use in food contact applications, including packaging, in food processing equipment, tubing and that sort of thing, conveyor belts even but that's not necessarily where they come from or where they all come from. It's not clear how much of the phthalates and food come from that direct contact. Phthalates are ubiquitous, they're in the environment, in the air, they're in seawater, they're probably in that Marianas trench, they're everywhere so it's not clear, at least not to me, whether there's a simple answer to that question. Well I'm glad I asked such a good question and thank you for a very nuanced answer and I appreciate that. One of the phthalate alternatives examined was Tris. Now I was at the commission back in the 70s when Tris in Children's Sleepwear became an issue and the minute I saw that word my heart started racing so I guess my question is how closely related to the Tris that was the phthalate alternative that was examined is the Tris that the commission banned in Children's Sleepwear? Fortunately it's not at all, Tris means, well Tri means three and if you go, a higher level of organization it's Tris so that's all it means and luckily for us that's not anything like the Tris that we know from times past all too well. All right, thank you, that's very reassuring. I did also want to talk about the point you were making about the 0.1% limit and it makes me a little bit nervous and I'm reading on page 58 of the draft NPR but it's the point you were making that the 0.1% limit is not risk based rather the limit is based on practical considerations the desire to prohibit intentional phthalate use while allowing trace levels and I think this might overstate the point and the reason I say that is some trace levels of some things are extraordinarily hazardous so I am guessing that we made some kind of a reasoned scientific health based judgment that 0.1% permitting trace levels is not going to be risky because if you think of ricin, cobra venom, lots of other evil stuff I guess the botulinum all of those and trace levels can be extremely hazardous so is there not at least some implicit risk based assessment that we did however informal? Well in this case the we is the Congress who passed the CPSIA, I don't know why they chose the 0.1% but that is the same level as in the European directive which preceded the CPSIA and the European Commission chose that level for the reasons I expressed is actually their reasonings their reasoning although I'm not aware of any you know written record of that. I do know that at one time the European Commission contemplated a risk based level based on migration rates and they decided that it wasn't practical that so they abandoned that and then that's how when they came up with the 0.1% now there are things that at such low levels might pose a hazard I think plenty of chemicals in biologicals but the phthalates are you know it's a matter of potency they're not that potent and really I think regulating the intentional use of phthalates in these particular products is sufficient. Yeah and you've just made my point when you say they're not that potent that's based on careful study and extrapolating from known effects from phthalates and so the only reason I say that is I can contemplate some judge in an appellate court some day saying what do you mean it's not risk based that's the whole point of what your mandate is and we do have the discretion to change that 0.1% figure out and all I'm saying is that it seems to me it's a much more rational and risk based number even if it's not a perfect number than people might have said. Okay now is where I get to display my ignorance and ask my morning dumb question and this has to do with dose additivity. I'm looking at page six of the backup staff report and I just would ask you to please explain this because it says if you have two chemicals where chemical A affects 10% of animals tested and chemical B affects 15% it says if the effects are dose additive then 25% of the animals would be affected and does that not assume that there's no overlap in effect on the animals because otherwise you could get two chemicals but one they are in effect causing the same type of harm and so one might affect 10% of the animals and one might affect 15% but the grand total would be 15% of the animals if the others are not affected. I'm obviously misunderstanding something. Well, the point of that is if you take low doses of any number of phthalates get a certain effect, a low effect. If you combine those low doses it has the same effect as a large dose of one phthalate and the potencies, they differ by two, three or five full. If you assume for a minute that they're all equally potent all that would matter is the total number of milligrams of phthalates. It wouldn't matter of active phthalates. It wouldn't matter what the combination was. In other words, you have to look at the total exposure to all of the active phthalates not just the individual ones to really assess the risk. I guess and I'm sorry to still not understand but the potency might just affect that 15% even more than just one of them in isolation but what I don't understand is why is it affecting 25% when it's more potent? It might just be affecting those poor rats that are susceptible that much more heavily. Well, the best, just the best way to answer that is after adjusting, tweaking it a little bit for potency, little factor for potency, if you expose an animal to so many milligrams of DINP get a defect, certain effect. If you expose animals to so many milligrams of DEHP you get a certain effect. If you expose them to both of those at the same time the effect is the sum of the individual parts and with when you're exposed to multiple chemicals at the same time the possibilities of what can happen is well that they don't interact in any way. They act completely independent. Maybe they act together. There could be synergism, they could counteract each other. We hear about drug interactions. Most of the time they don't make a difference but sometimes it can be deadly. And the point here is that with the phthalates we have experimental data. Imagine you can't test all the combinations of all chemicals but for phthalates we have the luxury of having those experimental data that show what happens when you combine them. I think I understand. I did wanna ask about, oh I'm sorry, I apologize. Commissioner Robinson. Thank you Mr. Chair. I would just first like to note that it's very clear to me in looking at the CHAP report and looking at the incredible efforts on behalf of the staff and looking at the seriousness with which all five of us up here have treated this subject that we all appreciate how critically important this rulemaking on phthalates is. While acute injuries may be addressed by a number of entities in our society, chronic kind of injuries like these are ones that are particularly important to government regulators. Phthalates aren't emerging health risk issue. We know that as Dr. Babich said they are ubiquitous. We're all exposed to them and because the scientific data has shown in animal studies that there are potential long-term health effects from this exposure it's critical that we address this. Congress obviously recognized this in 2008 when they gave us our orders on how we were supposed to proceed in terms of this regulation. They told us to convene a chronic hazard advisory panel, they told the CHAP what to do and they told us what we are to do once we receive the report and we have very much as we all up here agree follow the dictates of Congress. We strictly followed our statutory instructions on convening the CHAP, the CHAP followed the mandates on what they were to do and now we're starting the process that Congress told us to do once that report arrived. It's interesting that I was thoroughly briefed on the CHAP process before my Senate confirmation hearing over two years ago in May of 2012 because the CHAP report was, as I was told, imminent. After I was sworn in more than a year later I inquired about the report and I was told that it was more imminent. I'm absolutely delighted that we're finally at a juncture where we have the report and may do something with respect to this critically important rulemaking. This report has obviously been very carefully researched and drafted and was years in the making and I would just like to sincerely thank the group of dedicated scientists who worked so diligently. They reviewed a huge volume of data and studies, they closely evaluated the materials based on their reliability, relevance and adequacy and they concentrated on the most studied impact which as Dr. Babich has explained to us is certain phthalates anti-androgenic effects. I very much appreciate also the CHAP's candor about the gaps in the data and the uncertainties underlying the data. The CHAP outlined its assumption, its methodology for accounting for the data gaps and uncertainties by doing so the CHAP has enabled all parties including our very diligent CPSC staff to conduct an objective and informed review of its methodology and conclusions. It's important to note that limited data however is not no data. The science has shown us as Dr. Babich has so carefully explained to us that some phthalates known as active phthalates can cause developmental problems and male reproductive organs in multiple species. The effects of the active phthalates are cumulative and that a portion of our most vulnerable population, fetuses, babies and toddlers, are exposed to a dangerous level of phthalates. The biggest limitation we have at this agency is that we may only address those products within our jurisdiction. So I most sincerely hope that our sister agencies that have jurisdiction over other products such as food and cosmetics that contribute much more to our phthalate exposure will look at this CHAP report and do what they should do in their regulations. I really wanna commend staff for the thorough review and analysis of the report as well as the hard work that went into assisting the CHAP throughout this long and comprehensive process. Our staff has looked closely at each of the CHAP's recommendation to make sure they were supported by the underlying science as well as contemplated by the CPSIA and the staff's critical review of the CHAP report is evidenced by the fact that the proposed rule as Dr. Babich has explained to us does not include all of the CHAP's recommendations but only those that the staff believes are warranted by the existing science and are within our statutory mandate. I was delighted to hear your answer, Dr. Babich, to Chairman Kay's comment and Chairman Kay's comment with respect to the fact that during our comment period, we will certainly take into consideration any additional data that became available after the CHAP's cut off for the data that they were able to include in their report. And I just wanna ask one question, Dr. Babich, this should be obvious, but I just wanna be certain. As I read section 108B2C, Congress mandated two really somewhat different standards for what you and the CHAP were supposed to do with respect to interim banned phthalates and the additional phthalates that were not included in the statutory interim ban. And as I read this, they say that for the interim banned phthalates, well, the CHAP, you and we are to determine based on the CHAP report whether to continue the interim ban in order to, quote, ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals. And for the additional bans outside of the interim ban from Congress, that we are to, quote, evaluate the findings and recommendations of the CHAP and banned products containing phthalates as hazardous products, quote, if the commission determines it is necessary to protect the health of children. And I just wanted to be sure that when you looked at the CHAP report and prepared your recommendations to us that you were following those two standards as stated in the statute. Yes, we did consider those two standards as they were stated in the statute and the different populations that they refer to. You know, for example, what is it? Pregnant women, infants and children, and so on. I mean, in the case of the pregnant women, it's really the fetus that we're concerned about. But that is certainly part of our recommendation in our process for arriving at those recommendations. Thank you. You've explained to us very well, both in the review that you and the rest of the staff prepared with respect to your recommendations about the phthalate syndrome. And we certainly know, as you've explained to us, that not all phthalates cause anti-androgenic effects and that only phthalates meeting certain molecular structural criteria are associated with these. And this is what we call active phthalates, right? And as I looked at these extensive materials, you held up one set of the thick materials that my staff and I have reviewed thoroughly. What I was able to deduce is that we can really separate, just in broad categories, all of the phthalates that we're considering into a category of either active or non-active. Is that fair to say? Pretty much, there's always some ambiguity as to where the cutoff is, but yes. Okay, and am I correct that, because I made a little chart for myself on the active and the not active. And as I saw it, the recommendation of the CHAP and you on the staff is that all of the phthalates that we have decided based on the scientific data fall within the active category are to be banned. Correct. And do I understand correctly that then if a phthalate is not active, the next step of the analysis from the scientific data was to look at the margin of exposure. Correct. And you've explained to us what that is, but as I looked at the phthalate recommendations of the not active phthalates, I believe that all of them have an MOE of more than 100, and so we've decided not to ban those. Is that fair to say? Correct. So just making sure that we've got these categories. So with respect to DNOP, DIDP, and DINP, these are the three phthalates that were banned by Congress on an interim basis, right? Correct. And those you reviewed under the standard of reasonable, I should get this in front of you, it's reasonable certainty of no harm, correct? Correct. And to the population you've described. And what you found and CHAP found from the scientific data is that DNOP and DIDP were found to be not active with an MOE of more than 100. So the recommendation by both you and the CHAP is that we lift that interim ban imposed by Congress, right? Correct. Okay, and then the third one is DINP, and that was found to be an active phthalate, and both you and the CHAP have recommended that we make the interim ban permanent. Correct. Okay. Commissioner Robinson, I'm sorry, your time has expired. Oh, sorry, thanks. Thank you, Commissioner Burkle. Thank you, Mr. Chair, and I just want to reiterate what my fellow commissioners have already said, and that is to express my sincere appreciation to staff for putting together an incredibly complex package, a difficult one to prepare. And one, as my colleague, Commissioner Robinson, said, we've been waiting with bated breath for a while since we got here, so delighted to have it and really do appreciate all of your efforts on behalf of the CHAP and the CHAP report. My questioning and my line of questioning has to go along with what the chairman brought up, and that is the issue of timing and the data sets that were used by the CHAP, and then ultimately by our staff. So thanks to Caitlin in my office, she prepared a timeline. And since I'm a visual person, I thought it would be helpful if we looked at this timeline to determine when data sets were available and some of the criteria of the CHAP. So my staff is just going to hand out Nancy and give. We're going to hand out a copy of this, and I believe John has the time and may be difficult to see. I do want to thank the chairman for bringing up this issue and for assuring us that staff will view this additional data because I think it's critical to the rulemaking. It's pretty simple compared to what we've been looking at and some of the studies we've been looking at in the report. And Dr. Babich, if you could just walk through this with you, because I just want to make sure I have the dates right and I understand what occurred. You mentioned in your testimony, actually in your response to the chairman's question, that the CHAP used the NHANES data from 2005, 2006. That's correct. So that's the data that was used for the CHAP report. Yes. And I should explain, above the line are pretty much just when data sets were available that were used. And below the line are just the activities of the CHAP report. And the information we used is on our website. It was in the CHAP report, so it's publicly available information. So above the line, you can see February 2005, 2006, the NHANES data was available. That data set was available. And that's what the CHAP used in their report. You go then go down to October 2007, 2008. There was another data set of NHANES data available, but that was not used. Further, I see SFF data set. We obtained that. That was used. Dr. Babich, you referenced it in your opening presentation this morning. Are you aware, and do you know what the years of that data are? Or if you don't, maybe you could get back to us on that? Yeah, we couldn't look that up. OK, thank you. So proceeding down that timeline, you can see in 2010 there were two data sets available. In 2011, SFF data was available. And then in 2012, there was another data set available, 2009, 2010 NHANES data. And then you can see there, we drew a bold line where the CHAP had established a deadline, and we've heard this. And it's true, at some point, you have to draw the line and make sure that you have the information. And this is what you're going to work with. So I guess my question is, and it may be an unfair question because I don't know how you can speak for the CHAP. But my question to you is, to the best of your knowledge and information, why didn't the CHAP use that 2007, 2008, and 2009, 2010 data set in their analysis? It looks like the information they used was way at the beginning, and then anything that was submitted subsequent to that, any information and data sets were available, they didn't consider. Well, the CHAP did go back and revise their data, revise their analysis based on new data a couple of times as new data became available. And as NHANES published amendments to their data, it's a long process. You can collect the samples. It takes years to analyze quality control of the data. They release it. And sometimes they come back again and make corrections to their database. So this is a lengthy process. And the CHAP did do several rounds of redoing their calculations using newer data or updated data. And you have to remember that this is a process where the report is made over a period of time, over a period of years. And that analysis occur, you do the analysis. I mean, it's a long process. And analyzing these data is very involved. It's a complex. It's not a matter of putting in some numbers into a calculator. It's a lengthy time-consuming process. And the CHAP members, as well as anybody, are aware of these data, are aware of when the new data come out and whether there are any changes. This is what they do. And the fact is that the data remained essentially unchanged throughout most of this time until the latest data set became available. So when, I guess I'm confused, because when so when I asked the question, what data set did CHAP use, you said 2005, 2006, how would we know that they then factored in these letter data sets into their analysis? Well, this is the 2005, 2006 is the most recent data set that they analyzed. So they have not taken into consideration 2007, 2008 or 2009 and 10 that were available before the deadline? Well, they took it into consideration, but there was no change in the exposure levels during that time period. Well, staff on page 38 of the draft, staff references it. That there was, however, the most recent report, I'll just read from their staff's report. The most recent report from CDC shows that phthalate exposures are beginning to change as one might expect as projects are reformulated in light of the concern about phthalate toxicity. So it was apparent to everyone that things were beginning to change. I think the CHAP even references it in their report. And my concern is why didn't that peak someone's interest to say maybe we ought to look further? Maybe we need to consider these letter data sets. They are relevant. And as Commissioner Robinson said, this is critical stuff. And we want to get this rule right. And so it would seem to me the very most current data is extremely relevant to any rulemaking that we undertake here at the CPSC. The latest data set, I mean, the report was done when this latest data set became available. And the CHAP was aware of it. People who have looked at these data, yes, there are some changes, some phthalates, some anti-indrogenic phthalate exposures are down. Others are up. That's not necessarily going to make a dramatic change as to the outcome of the risk assessment. And not only that, it was simply at that time it's not practical to go back and redo the entire report. It was practically at the printers at that time. Well, I guess, and one of my questions this morning is, is staff aware that scientists who have assessed the impact of the changing phthalate exposures have concluded that an updated risk assessment would show a hazard index well below 1? I mean, that's extremely relevant to the promulgation of a phthalates rule. I think that some scientists have said that the hazard index would change, would go down. Others are not so sure. And that's something that we will certainly look at during the public comment period. But you have to consider that the hazard index, even if it goes down a little bit, whether that would change the recommendations or change the conclusions is another matter. Thank you. I see my timing has expired. Thank you, Dr. Babich. Thank you, Commissioner Berkl. Commissioner Movorovic. Thank you, Mr. Chairman. I'd like to begin by making a fantastic announcement. Some might notice that my special assistant, Mike Gentine, is not behind me today. He and his wife have been expecting for some time. And I'm so pleased to announce the birth of Miles Walter Gentine yesterday evening, about half past six, 8 pounds, 13 ounces. And everybody is doing very well. And on Mike's behalf, I want to thank everybody for their collective thoughts and good wishes and ask for updates. Here you go. It's hot off the press. I'd have pictures. But young master Gentine wouldn't sit still as Mike tried to get that bow tie around his neck. And Caitlin suggested to use a clip on. And Mike's a traditionalist. He said, no son of mine's going to wear a clip on. So once we're able to get that bow tie around the child, we'll be able to send out some pictures. I'd like to reiterate also the compliments to the staff on the amount and the depth of the work that's provided today. I would also like to continue with some of the questioning with regards to the data that's used, in particular, among the very many recommendations that were made, just in particular the recommendation as it was the CPSC's charge to determine whether or not within a reasonable certainty of no harm to continue the interim ban on DINP. So that said, there's a couple of points Dr. Babich that you made with regards to when the CHAP. And I understand that you're doing your best to interpret the CHAP and you don't represent the CHAP. But then again, part of our work was to review the CHAP work. So in doing so, you mentioned that the CHAPs look at data with regards to make their findings, including the fundamental finding with the hazard index level for the methodology to justify continuing the interim ban on DINP. You mentioned that the CHAP evaluated the data that was available. You said it wasn't up until dotting the I's and crossing the T's. And then at another point in time in your testimony, you mentioned that it was up until the report was practically at the printers. And I completely agree with Commissioner Burkle that at some point in time you have to stop collecting data and you have to move on and make some analysis. But as we look at the time frame that Commissioner Burkle provided, the data set that the CHAP used to draw its conclusions, which we're basing our recommendation on continuing the ban on DINP, was provided a long, long time ago. So that 2005-2006 data was available in February of 2010. That's the data set that the CHAP used to draw its conclusions, that we concurred and made a determination to continue the ban. And as I see from the time frame, that's between the first and second CHAP meeting. You couldn't mean that they were dotting the I's and crossing the T's in the middle of 2010 before the 2007-2008 NHANES data set was available in the chronological time of October 2010. Can you comment on the fact that to make that determination for DINP to hit that hazard index level? And I appreciate the fact that there's a lot of recommendations. So different data sets are going to impact different recommendations that are included in the staff package here, but just specifically with regards to DINP, does the decision to not look at, even though it's within the time frame the CHAP established with which they'll look at data to make their determinations, is there any, were they really going to the printer in the middle of 2010, and therefore that's the justification for not using 2007-2008 NHANES data set or the 2009-2010 NHANES data set? No, but the data hadn't changed. The data hadn't changed until the very end. So it wouldn't have made any difference in their report if they had gone back and redone the entire analysis yet again, which they had gone through several cycles of this. Thank you, Dr. Babich. Dr. Babich, specifically with regards to the data that's relevant to make the justification that there's a hazard index above 1, and therefore that's the methodology that we concurred with the CHAP's approach. You're saying that the data set did not change to impact that conclusion, the risk assessment. Correct. And I know you've seen the reports that are giving to us. I have to conclude that you're saying that they're erroneous that the DEHP data set, which is the most significant contributor to the overall cumulative risk, did not change significantly in 2007-2008 NHANES data set nor the 2009-2010 data set. Saying that there were no clear trends until the latest data set was available. And when you mean the latest data set available, there's been a lot available. And we're not talking about last week. There was a data set available in late 2013, data set available in 2014. All of these data sets, since February of 2010, were not used, they were not available, and none would fundamentally change the outcome of the risk assessment to be at a hazard index level above or below 1, which is the methodology that we agreed with the CHAP's approach to determine whether or not to continue the interim ban on DINP. I'm saying that there were no apparent trends. A lot of people have looked at these data over the years. And yes, there are fluctuations, and you look at different subgroups and so on. Look at the general population, look at different subgroups. And you think you see something, but it really didn't become clear until that last data set. And a lot of other people. Can you please define, I'm sorry for interrupting, but can you please define what data set you're because I don't know if you mean the data set within the 2012 time period, or can you just refer to it specifically? The one on the chart, the 2011, 2012 NHANES data set. Thank you, I apologize for the interruption. Please continue. So others have concluded that there were no clear trends until that time. And I might point out that the NHANES is part of the data, but that it does not include data on infants, and that the data on infants that are available to us are the same. That has not changed. And I know that we're looking at the CHAP report, and Dr. Babich, you are one of the preeminent experts in this field scientifically. It's not while they took a de novo approach. I appreciate your humility. The CHAP was asked to take a de novo approach to start afresh, but you have a very long history in studying DINP on behalf of the public. On behalf of the entire commission, I want to demonstrate my appreciation to you. And there has been a significant consistency, Dr. Babich, with your analysis, in particular, again, DINP. I realize the scope of Section 108, many of the recommendations we had to move beyond this. But this remains the most controversial element before the commission right now. In 2002, the staff package to not recommend banning DINP. Again, in 2007, CPSC sent a letter to California State Senator George Runner. In that letter, quoted that the CPSC staff has kept abreast of the new research and has not seen anything that would cause a change in the staff's position on the issue. And then you also have congressional testimony, Dr. Babich, where, and I'll quote from that to assess the potential health risks from DINP, CPSC staff collaborated with scientists in Europe and Canada to develop a laboratory method to measure migration of DINP from products. You go on to say, for the majority of children, the CHAP concluded that exposure to DINP poses a minimal to non-existent risk of injury. And you conclude in your testimony before Congress in 2008, therefore, we concluded that exposure to DINP in these products did not present a health risk to children. And in February of 2003, the commission voted unanimously to deny the petition requesting a ban of PVC in children's products. I'll get back to that, if you will. I know that this is my life part of the questions, but I'm out of time. So thank you, Dr. Babich. Thank you, Commissioner Mohorovic. Dr. Babich, I know you're in a tough spot to have to try to divine the intention of an independent body of experts who were impaneled specifically as a direction from the United States Congress for the express purpose of trying to provide some scientific clarity and some scientific certainty on a very difficult issue. And I think that's one of the reasons we need to remain mindful of the specific statutory structure that we're under here, regardless of what may have been some scientific views, even by the commission staff prior to that. The Congress did give the commission and the CHAP a specific charge. And I do want to read again, and Commissioner Robinson talked about this earlier, the instruction from the Congress on the interim bans was to, quote, ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety. And so that's the charge on the interim bans, regardless of what any other scientists might think and regardless of what may have transpired prior to the date that the CHAP considered this. And I also think that you've done an excellent job demonstrating both the fact that there have been, as you put it, there was no difference in the trends that was discernible in the NHANES data, even with the issuance of the 0708, 09, 10 data, until, basically, the CHAP was done when it was discovered at that point that there might be a difference. And I think you also did a phenomenal job of pointing out that different scientists will often reach very different conclusions. And I think that's exactly why Congress created this particular statutory scheme and directed the Commission to impanel an independent chronic hazard advisory panel on CHAP to give the Commission this kind of guidance and make sure that we base the Commission based any policy decisions on the CHAP's recommendations. So thank you for trying to work your way through a difficult position today. I want to switch to Mr. DiMatteo and talk about the effective date. And I want to read from a few provisions from page 62 of the draft NPR, the Federal Register notice. So the staff concluded that this would have, quote, minimal impact on manufacturers, and, quote, and then in a separate vision, open, quote, a relatively small percentage of non-mallable toys would need to be reformulated to remove DINP, close, quote. And then in a third part, quote, open, quote, minimal effort by testing laboratories, close, quote. And as the staff mentioned as well on the effective date, the Administrative Procedure Act only requires that an effective date must be at least 30 days after publication of the final rule. Mr. DiMatteo, do you believe or just staff believe that, and of course the staff recommend 180 days, that there is ample room for the Commission should it choose to decide to issue this NPR to consider moving the effective date much further forward and much lower in the number than 180 days based on the findings that staff made? I think that if an adequate reason is given that you could potentially move it up with less time, but certainly not anything below 30 days. Correct, correct. And do you believe, though, that a minimal impact on manufacturing, relatively small percentage of non-mallable toys would need to be reformulated and a minimal effort by testing laboratories would qualify as adequate reasoning from your perspective? Potentially. You would really have to ask the technical staff that that's their analysis, which I have no reason to disagree with, but certainly they would be able to talk to that better than I would. Great, great. Thank you, Commissioner Adler. Thank you, Mr. Chairman. And I also want to reiterate the point that you made is that when the staff was assessing the hazards associated with phthalates before, I'm assuming that the legal standard they were applying was the legal standard set forth in the Federal Hazardous Substances Act. That ain't the standard that we're applying under Section 108. And Commissioner Robinson helped me avoid major embarrassment this morning when I was talking and thinking about DIOP, because DIOP is not being assessed under the standard of reasonable certainty of no harm. It's being assessed under the standard of whether we determine it necessary to protect the health of children. The point being that the legal standard you apply has a lot to do with the conclusions that you reach. And Dr. Carlson, since Dr. Babbage isn't here, I'm going to at least direct a question to you if I might. And that is, with respect to DIOP, I would just like it if you could explain something to me. And I'm reading from the CHAP report, which was also picked up by the staff briefing package. And it says the hazard from DIOP, actually it says the hazard foam DIOP, but that's a typo, is unknown. Minimal data do not demonstrate anti-androgenic hazard. However, the isomeric structure of DIOP suggests that DIOP is within the range of the structure activity characteristics associated with anti-androgenic activity. Could you explain to me what isomeric activity is and how that relates to the general hazards that we were addressing with respect to DIOP? My understanding is it comes from isomers. And so if you could just give me a brief 30-second biochem lecture, I'd appreciate it. OK, thank you. The isomeric structures they're referring to have been previously commented on in terms of the carbons necessary for being an active or an inactive phthalate. So when the CHAP was assessing this compound, because there was a lack of data associated with DIOP, they actually looked at that structure and tried to determine whether or not it fit into the carbon 3 to carbon 6 backbone of active phthalates. Reading from a well-known textbook called Wikipedia, it says isomers do not necessarily share similar properties unless they also have the same functional groups. Does that have any meaning in the sense here that the isomers associated with DIOP do not belong to the same functional group as other anti-androgenic phthalates? I think I'm going to pass off at this point to the mic, because it seems to cast. And by the way, you need not answer that. I tried to grab Mike before the meeting and tell him I was going to ask this question. So this is maybe something that you could talk to me later about. I think the question was whether the different isomers makes a difference if they're not part of the appropriate functional group. And it would appear that it's the side chain, the isomeric part of the molecule that makes a difference. So yes, it would matter. The different isomers, in this case, would matter or may matter. And so I do take it to you are comfortable with the conclusion, the staff recommendation, that at least at this time we do not recommend a band with respect to DIOP. Well, the reason being, there's virtually no data in animals, at least not at this time. And with respect to DEHP, that seems to be a particularly potent phthalate. And so I was just curious, how widely used is DEHP? And again, you may not know the answer to this, but what is it used in, if not children's toys or articles of childcare? DEHP has been the most common phthalate, probably, for many years. It's called a general purpose plasticizer, which means exactly that. It's used in lots of different things. I didn't go into this for the briefing, but back in the 80s, DEHP was in toys and childcare articles. The commission started a rule making and the manufacturers, you know, said we'll just take it out and it was replaced by DINP. So it's used in a lot of different things. It's been used for a long time. There has been a trend to remove, so anyway, we took DEHP out, more or less, in the 1980s. And then later on, of course, through the European Commission's actions, it was then banned in the European Union. It was still used in Asia, in other parts of the world, in these children's products. There has been a general trend in, I believe, or I am told that DEHP is slowly being replaced by other phthalates and other compounds, most likely due to concerns about toxicity. And then continuing the point raised by the chairman earlier, this will be put out as an NPR and the entire world, including people concerned about DINP will have the ability to file comments with the commission with respect to the proposed action on DINP and at that point the staff will be able to analyze the comments submitted by folks who are interested in DINP and other phthalates and will be able to incorporate any thinking or any change of thinking that the 2011-2012 NHANES dataset might raise. Absolutely, you know, the plan has been in place for a long time that the proper play, obviously people will comment on the CHAP report and that the proper time and place for responding to those comments will be during the public comment period after publication of the NPR. Also, there's no data that's coming out that is suggesting that DINP does not have anti-androgenicity. The issue is the exposure, am I correct in stating that? Correct the, well the issue is the exposure, not just the DINP but to all phthalates. No, I certainly understand this. But it's exposure in fact, yes, if anything there are more data to support the fat DINP is in fact anti-androgenic. You know, it's amazing the pace, the growth of the literature. The number of papers published virtually every day, I mean it's astounding. Well this may be an unfair question, feel free not to answer it but if you were to fly to 50,000 feet and look down at the recommendations from the CHAP and at least your emerging understanding of what's in the 2011-2012 NHANES data set. Do you see anything there that is such a dramatic departure from what was before the CHAP that it would lead you to change your thinking about the recommendations of the staff and the recommendations of the CHAP? Not necessarily because, you know, people have been reformulating products to remove phthalates for a long time. HP was phased out in the 80s from these particular products. The manufacturers of toys and childcare articles started reformulating their products in around 1999 and some of them came out and said, you know, we're just getting rid of the phthalates. Just, you know, forget what the scientists say. If people are worried about it, we're going to reformulate. So this has been going on for a long time. Any rulemaking that I've been involved in at CPSC, as you know, it takes a while to pass a regulation, a mandatory regulation and the most usually the manufacturer, if there's a problem with the product, like a fireworks device or something else, the manufacturers, they know it's a problem. The big companies at least fix it. And so by time you get to the final rule stage, it's like, so what's the cost benefit? Why do we need to do this rule? And, you know, I think, because if you don't, then five years later you'll be addressing the same issue. Thank you very much. Commissioner Robinson. Thank you, Mr. Chair. Dr. Babich, I would just like to regroup a little bit on where I ran out of time the last round of questioning. And let me back up. We talked about the different standards for the interim band phthalates and the other phthalates considered by CHAP and by you on the staff. But we also have a mandate from Congress in the statute they gave us that the CHAP and you have to not only consider the effects of the phthalates individually in isolation, but also cumulatively, is that right? Correct. So just quickly, we talked about the interim band that we're looking under reasonable certainty of no harm. And we talked about DNOP and DIDP not being active, in other words, not being associated with male reproductive problems or developmental problems. So the recommendation is to lift the band. And then DINP, which is one of the active phthalates associated with male reproductive developmental problems and that the recommendation is to make the temporary band permanent. So let me just move on to DIDP, DPENP, DHEXP, DCHP, these were found by both the CHAP and you to be active phthalates. And there's a recommendation of a permanent band by both you and the CHAP, correct? Correct. Okay, and DIOP, Commissioner Adler's talked about. And I only want to follow up with that you are recommending that we continue to examine that as we have the resources, but that at this point it just, we don't have enough data to make a decision on a band. Correct. Okay, and the last ones were DEP and DPHP and the CHAP did not recommend any bands on this. And I would just like to comment that what the CHAP said and I assume the staff is in agreement is that we should do additional study. But as you've noted, this is a very complicated effort and an expensive effort. And I would just like to call on our fellow health and safety regulators as well as the academic community manufacturers and other stakeholders to study those phthalates further. So let me move for a moment if we could, Dr. Babich, to the issue that Commissioner Burkle raised with respect to the data. And I don't want to use the term, I don't want to get messy about the term data because there's scientific data with respect to the molecular structure of each of these phthalates with respect to them being active and inactive. The NHANES data on the other hand has to do with people over the age of six and what exposure they have to phthalates, is that right? Correct. Okay, and the NHANES data has nothing to do with the data concerning molecular structure of the phthalates as Commissioner Adler pointed out, is that right? Correct. And nothing to do with whether a phthalate is associated with male reproductive development problems, right? Correct, although I don't know the exact criteria that CDC uses to decide, obviously they're gonna test for a chemical if they think it's has some importance. But no, the data themselves do not tell us whether it's antigenogenic, although the data are used by people, epidemiologists and so on. I understand that because it shows the exposure, but it doesn't have anything to do with the scientific data of the structure, is that right? Correct. And as you pointed out that the data with respect to children under the age of six is separate from the NHANES data. Correct. Okay, and as we've said, but when the time comes after you've considered the comments and this additional data, then I assume doing what we always do, you will make recommendations to us on a final rule, which may be the same or different than the one you're recommending now, right? Exactly. I guess just generally, I'd just like to ask you a couple questions with respect to the hazard index that we talked about. It's generally agreed that the hazard index above one is something that we very, very much don't want to have occur, right? It means that we've exceeded a level of data where there may be risks for the adverse effects. And we want to keep it as low as possible as in making decisions about these phthalates, right? Well, yeah, yes, although certainly if you're at or near one, you may not be as worried, you know, lower is better. There are additional chemicals other than phthalates, as I understand it, that we are exposed to that are also anti-androgenic, is that right? Correct. And those contribute to our overall exposure? Yes. And that, as I understand it, was not included by CHAP in the hazard index. Only phthalates were included. Well, for a couple of reasons, one, it's not, wasn't part of their mandate, but also because of the availability of data, even though, you know, NHANES measures some of these compounds, they're not necessarily in the same people where they're measuring phthalates and they're not, some of these compounds aren't measured in NHANES. So the CHAP assessed that as best they could. And assessed. And what they said was that at the very least, it has a small effect of increasing the hazard index. As a worst case, it might double the percentage of people who would have a hazard index greater than one. And as I understand it in your discussion and your materials and the staff's materials about the hazard index and the approach that CHAP took, that their calculations were actually conservative in terms of erring on the side of underestimating the exposure. Is that right? Well, that's something like that. I think that they were more accurate than the alternative approach. Which would have bet, would. Well, yeah, what happens is the easy way to do this would be to take data, NHANES publishes summary data. You get average standard deviations and percentile values for each phthalate. And a previous risk assessment looked at the summary data which means that you get, you look at the effects of each phthalate separately. And then when you try to add them up, the problem is it works okay for the average exposure, but when you get out to the tails, to the 95th percentile level, what you're really doing is adding up 95th percentile. It's not the 95th percentile hazard index, it becomes the 95th percentile of the 95th so you're sort of compounding risks that aren't really there. And this is something that the government as a whole has been criticized for very much in the past. I suppose not entirely called for, in some cases there are statutory requirements, wanna know the absolute highest exposure, but the point is it's been a point of contention. But the only way to accurately assess the data is to do what the chap did, is to look at, calculate a hazard index for each individual and then, instead of starting with the average doing calculations, you do the calculations for everybody and then you do the averaging and analyzing. It's a lot more work, but it's the right way to do it. So as I want to do, I'm gonna try to summarize that simply and see if I do this accurately. If the alternative approach to what the chap did was used, the result would have been an overestimation of the 95th percentile, is that fair? And so the approach that chap took, if anything, errs on the side of underestimating, is that fair? Well, it was intended to be as accurate as possible. But it doesn't err on the side of overestimating, that's the other way. Okay, thank you at this point. I have nothing further to add. Thank you, Commissioner Robinson. Commissioner Berkel. Thank you, Mr. Chair. I wanna comment that when Commissioner Kay, Chairman Kay left the room, he left me in charge. You did great. I didn't get quite enough done that I was hoping to get done. Well, you were ready to call me Commissioner Kay, so I see something changed. There's been a coup. Well, I have a couple more questions for Dr. Babich and I certainly appreciate the length of this hearing and the difficulty of it. So I'll get through these, we can be done. We, and I wanna get something clarified in my previous round of questionings. You mentioned that the CHAP only used the 0506 data and not the other. Did our staff look at the more recent data or did they strictly use what the CHAP used? Well, the staff looked at the most recent data. We've seen the, some of the submission, well, we've seen the submissions, the comments on the CHAP report, and we've also looked at publications relating to the latest data. And informally spoken to colleagues about what these data might mean. We, of course, have not yet done a detailed analysis of the data ourselves. And just to clarify, when you say the most recent data, even the last 11, 12, 2011, and 12, that data as well. Right, the data that were released, I guess it was late last year. Okay, does our health sciences staff have not only the expertise, but do they have the resources to derive on the exposure from the NHANES data? Well, I think that it would take a significant effort, and it would involve not just health sciences, but probably the Directorate for Epidemiology for help with the data analysis. And it's something that could be done, but it's not a Saturday afternoon project. Any idea of how long it would take? We haven't sat down and tried to figure that out. The NHANES, it's a very complex data structure, and you have to make sure you understand that before you, the NHANES, what the different data means, and so on, it's a kind of an arcane subject. So it would take some work just to gear up to do that. How would the staff, could they or would they consider viewing or reviewing outside analysis with the exposure estimates, and how would they approach it? Would they redo it? Would they spot check it? Would they replicate it? How would they go about doing that? And I think that we would, the specifics of how we would approach this, we haven't worked out yet. We've certainly talked about it, and I've raised the issue way back when those data were released. And the answer may be all of the above. There has been an awful lot of talk about statute today, and so I'll just throw in my two cents about statute and what Congress directed us or directed the CHAP to do, and this is of concern to me. In CPSIA, it says review all relevant data, including the most recent, best available, peer-reviewed scientific studies, and so I see a bit of a gap there on the part of the CHAP report, and that's primarily the reason why I brought up this timeline today and talking about what data was used, because I don't believe they used the most recent data. I just wanted one other question for now, and that is with regards to the 910 data, are you, earlier, and I guess I should clarify this, you're saying that reasonable risk would be less than, unreasonable risk of safety would be less than one? Well, I'm saying that you would, at the very least, need to have a hazard index no greater than one. Okay, and so has anyone plugged in, and are you aware that if you put the 09, excuse me, the most recent data, and that's the 1112 data, into, you put that into the, and use exact methodology that the CHAP used, that that hazard index will be below one? We have not done that. We have seen comments of people who have reanalyzed the data. Would you agree that that's a critical piece of any analysis that's being done with regards to rulemaking? It's a, if it would change the conclusions, and that's something that we will obviously address during the public comment period, and we will consider the public comments, we will consider any new data that become available. Thank you, I finished with my questions for now, thank you. Thank you, Commissioner Berkel, Commissioner Malerovic. Thank you, Mr. Chairman, and thank you, panel. I have a question again about, well, I want confirmation, actually, with regards to the threshold that's been established for the reasonable certainty of no harm in determining continuing the interim ban on DINP, that recommendation, and reviewing the other recommendations based on notice and comment. Is there, it's stated in the package here, and again, you just mentioned it, that there would need to be a hazard index of less than one needed to ensure a reasonable certainty of no harm. Is there any reason to believe that the staff has less faith in the methodology that they concurred with in first reviewing the chat? What I'm wondering is, is there any chance that somebody looking at this might think it's a Lucy with the football and the old peanuts cartoon where we said we liked the methodology, but then when the numbers change, we move to a different methodology to make the case. Is there any reason to believe that that hazard index methodology won't be used to, in consideration of the notice and comments, to confirm or change the recommendation to the CPSC to continue the ban on DINP? Well, I mean, we're not changing the methodology of the risk assessment. Unless, in the unlikely event, that suddenly some new methods become available. As far as the interpretation of the hazard index, there is the issue of, what does the hazard index represent? Obviously, a hazard index greater than one means that there may be a risk. There's also the part in the statute about the, what is it, the adequate factors? Adequate margin of safety. Adequate margin of safety as to what exactly that means. Thank you. When the staff determined, in the staff's making their determination, they chose not to rerun the numbers on the subsequent NHANES data. Why not? I mean, I don't ask you to explain why the CHAP ignored two subsequent data sets from the same apples to apples data sets produce the same way. I don't expect you to be able to rationalize why the CHAP ignored those two subsequent data sets. But in our staff making a recommendation, they were clearly aware of those data sets as well as two subsequent data sets, yet came to the conclusion and felt confident enough to make a determination to the commission and recommend that we make a determination to continue the interim ban without considering how those subsequent exposure data might change the outcome on the critical factor which has been defined to identify whether or not there's been a reasonable certainty of no harm. You mentioned that the staff considered it and rejected it. Can you explain a little bit more? It seems contrary to a lot of the thinking that I see around here where the staff would absolutely want to always take full advantage of the most recent data, regardless how that might change an outcome. The data were released at a time when the CHAP report obviously was nearing completion. We were aware of the data. We looked at the data. We saw public comments. We saw comments, later saw comments coming in. We saw publications of the data. And what they all suggest is something of a trade-off is that some phthalates going down, others going up. For one thing, it's not immediately clear that that would affect the risks significantly. The other consideration was that the CPSIA requires a CHAP to do the risk assessment and required a risk assessment or the rule to be based on the CHAP report. And so it was decided that the time to do any additional work would be, or we wouldn't do any additional work at least until the NPR is published. Dr. Babich, I appreciate completely that this is not a factor as simple of changing a couple of variables in the computer and the calculator and out pops the new risk assessment. I fully appreciate that. But in determining that we won't have time to make those critical calculations, was that based on time frames that were provided by leadership either in the executive director's office in terms of when a staff report was to be produced and then therefore the staff had determined we just don't have the time to get it done, to get a package, to meet the briefing time, to have a hearing. So we have to make a recommendation on what we've got right now. Did the time frame impact the decision not to run the data or did the staff figure we just don't want to run the new data and are confident enough to make that determination on continuing the interim ban on time? Well, no, the timing had nothing to do with it. It was the process, the steps of, it's got to be based on the CHAP report and is it going to make a difference anyway? We'll deal with it. We were advised to address it as part of the public comment period. I appreciate it. Thank you, Dr. Babbage. Thank you, Mr. Chairman. Nothing further for me. Thank you, Commissioner Moorovic. So I just want to continue along the same line of questioning that both Commissioner Buerkle and Commissioner Moorovic have raised and I want to go back to the language from the statute from section 108 of the Consumer Product Safety Improvement Act that Commissioner Buerkle quoted from. And I think the key word is review all relevant data. The word is review. Do I have it right, Dr. Babbage? And I'm referring to the very helpful chart. Thank you to Commissioner Buerkle and Caitlin Costello for staff. It was wonderful. So I have it right that the CHAP primarily relied on the 2005, 2006 NHANES data set that was their baseline data set for the work in the CHAP report. Is that correct? Correct. And then as they were moving along and as the process was going along, the NHANES data from the 0708 was issued, the 0910 was issued, they were aware of it. If I heard you correctly, they considered it. They reviewed it. They did not believe it changed even with fluctuations. It did not identify any particular trend and it did not change their ultimate conclusions. Is that correct? Well, this is what some of the CHAP members, I mean, this is what they do. They know when it's coming out because they know the people who produce the data and all of this. So they are very much aware of when the next data sets coming out and so on. And the report, of course, was essentially done. At that point, yes, the CHAP considered they reviewed all the data during the entire process. Of course, this last set, it was too late to put anything in the report. It had already been peer reviewed and so on. However, just informally, they doubted whether it would make any of change to their recommendations. But clearly, prior to the release of the 1112 NHANES data set, do I have it right that the CHAP reviewed, at least reviewed all of the prior released NHANES data set up until from 0506 through 0910? Right. Correct. So the only data set that we're talking about is the 1112 data set. Yes. And that's the data set that should the commission issue the NPR. As I mentioned at the beginning, I plan to direct staff to include and consider its views on that data set as part of the final package. So I think we should focus on the data set that was not, sounds like, not really available. As we have all acknowledged, there has to be a cutoff. And the CHAP made a reasonable cutoff in its own estimation. And then, again, according to Commissioner Berkels' chart, this data set came out after the fact. The other thing that I want to touch on goes to the timing that Commissioner Morovic mentioned. And I think it is an important factor to consider that Congress, as part of the statutory scheme, directed the commission to promulgate a final rule, 180 days upon receipt, or after receipt of the CHAP report. And I believe that that is approximately mid-January based on when we received the CHAP report. So we're clearly not going to make that, but the fact that we're probably not going to make that doesn't mean that we shouldn't endeavor to follow the law and try to get it done as quickly as possible, recognizing that we have to put in the requisite scientific and technical work and make sure that it's done properly. Commissioner Adler? Just a quick observation, and just at least to help me put it in context. One of the things I like about this agency is we are a creature of statute. We follow our statute. We are also a data-driven agency. And so, what we're doing is applying a specific, concrete set of standards that were implemented in CPSIA. That's the standard that governs our judgment, and I think that's the standard that you're applying. The other point I would make is that because we're data-driven, I do not sense any preconceived notion in the staff's part about any outcome that must be followed. And so, if we get new data or if we get new analysis that changes the staff's thinking, the staff's thinking will change. And I, for one, am delighted to follow whatever the data, wherever the data lead us. And so, I just wanna make that as an observation. And the thing that makes me very comfortable is the fact that staff will be analyzing any submissions, and I know there are gonna be submissions. We've already had submissions with respect to both the CHAP report and the staff recommendation. I guess I'd also wanna thank you once again for a really, really outstanding presentation. All of the staff, this is really one of the finest reports and presentations I've seen, and I really wanna thank you. Commissioner Robinson. Dr. Babich, I wanna turn attention to another type of data that I believe you referred to in response to questions by Commissioner Adler. You said that since the CHAP report, and please correct me if I misunderstood, I thought you said that since the CHAP report, there is even more data with respect to the anti-androgenic effects of DINP. Did I understand that correctly? Correct. Could you just describe that generally, the new data? Well, there are a constant stream of new data that have been published since the CHAP report was completed, since their literature cutoff date. And we do our best to keep abreast of this. And there, at least one study comes to mind confirming that DINP is anti-androgenic, that these kinds of effects were seen in mice, which was something of a point of contention because most of the data on phthalates are in rats. And there was a concern about the lack of data in other species. So we have that data, there are new epidemiological studies that have been published that continue to find associations between phthalate exposures in humans and adverse health effects. So, you know, there's new data coming out all the time. The challenge is to assess, you know, whether or when there is enough new data that it would affect the assessment. Thank you. And again, I just want to thank staff as the other commissioners have for this superb job. Thank you. You help us do our jobs well. Commissioner Buerkle. Thank you. I just have a couple of questions about the peer review. The peer reviewers of the CHAP, they identified problems with the draft. And in the final report that came from the CHAP, those issues that they raised weren't addressed. And so I'm wondering, did the CHAP disagree with those suggestions and concerns or is there an explanation why they agreed or disagreed with them somewhere and how would we be able to review those comments? Well, I mean, could you be a little more specific? I think that the overall, I think the comments from the peer reviewers were glowing. I mean, I wish anything I wrote, you know, got such glowing reviews. There were questions, and we'll get you to specifics, but there were questions about the cumulative risk and the use of that, the fact that there wasn't a systematic process followed. So we'll get you the questions. And does the staff have any plans to deal with those comments or the peer review comments? Well, you know, the peer review comments were for the benefit of the CHAP. They did respond to those comments and they did make revisions to their report. They, in fact, took those comments to heart. You know, there are always comments that say, well, gee, you should have done this, this, and so on. And yeah, a couple years and a couple million dollars, we might be able to do that, but would it affect the answer? But, you know, beyond that, those comments were for the CHAP. Whatever comes in during the public comment process, we, the staff, will respond to. Thank you, Dr. Babich, and thank you to all of the panelists today and for the staff for an incredibly complex package and for all of your hard work on it. Thank you. Commissioner Mohorovic. Excellent, thank you, commissioners. Thank you, staff. Thank you for those in attendance and viewing online. This concludes this public meeting of the United States Consumer Product Safety Commission.