 I'd like to call the meeting back to order. We just got an email from our former executive director who's trying to listen saying, I'm hard to hear, which is amazing to me. So I will try to speak directly into the microphone and with greater clarity and volume. At any rate, we are delighted to have Dr. Josh Sharfstein and Dr. Andrea Gielin here from Johns Hopkins School of Public Health. And so I invite you now to take the podium and address the crowd. Great. Thank you very much, Commissioner Adler. My name is Josh Sharfstein. I'm a professor of the Practice Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health. And I'll be talking for a little bit then Professor Gielin will come up and talk for a little bit and then I'll talk a little bit more and then we're done. So that's the plan. And thanks. Well, we're so delighted that you made a trip and we know you've got serious time constraints so we look forward to hearing from you. No problem. My only regret is that I don't have time to stop at Pines of Rome. If you know that restaurant. I do, I love it. If I said... It's about to close too. Don't say that. If I said that I went on 90% of my dates to the Pines of Rome in high school, that would be an underestimate by approximately 10%. So, all right. Crib bumpers, we talk about Maryland's experience and some other data that Professor Gielin is gonna share. Let me just say that I previously served as the Secretary of Maryland's Health Department and the Commissioner of Health in Baltimore City and Professor Gielin is really considered one of the top, if not the top prevention experts in the field of public health. She has won pretty much every award there is to win in that field. She's not gonna say that so I will say that. And including having served as President of the Society for the Advancement of Injury and Violence Research and the Award for Excellence from the American Public Health Association and I could spend my whole time reading off her awards. So, we'll talk about Maryland's experience. Then Professor Gielin's gonna speak and we'll talk a few comments on the CPSC staff response. So in Maryland there's a law that authorizes the Secretary of the Department to hygiene to regulate hazardous substances and it says that the Secretary can declare as a hazardous material anything that the material that the Secretary finds is intended for use by children that presents a electrical, mechanical or thermal hazard and if labeling cannot protect the public health and safety adequately the Secretary has the authority to adopt rules and regulations to ban the sale of the hazardous material. And so our process on crib bumpers started in April, 2011 when we published a request for comment about the use of crib bumpers and that we provided a little bit of data, some links to some scientific publications and we got a public comment from a variety of people. In May, 2011 we presented the comments and all the papers that we could find to an advisory panel. It had four senior pediatricians in the city and one public health officer and as a result of that meeting, four of them, all of them agreed that the bumpers should not be used and four of them suggested that the state consider a ban. We subsequently heard from the Juvenile Products Manufacturers Association which had submitted comments but they wanted the opportunity to meet with the advisory committee directly and we gave them that opportunity in July, 2011. There was a meeting just for them and the experts that they wanted to bring and there was an extensive discussion, the panel was joined by an assistant medical examiner in the state of Maryland and at the end of that the advisory panel agreed that there was no meaningful evidence of benefit and persisted with its overall recommendation that the state consider a ban. In October, 2011 the department published a second request for public comment this time on a proposal to ban the sale of baby bumper pads. So this was not actually a formal regulatory proposal, it was a, this is what we're thinking but we want public comment before we consider proceeding. We got more than 30 comments back in October, 2011. In July, 2012 we actually proposed a regulation in which we referred to the comments, we made changes to the original proposal and the regulation was proposed to ban the sale of non-mesh crib bumpers in the state of Maryland with a effective date of June 21st, 2013. In December, a committee of the Maryland General Assembly held a hearing to review the proposed regulations and a decline to ask for a delay which basically is what its authority is in that situation more or less but they declined and in June, 2013 a ban on the sale of crib bumpers went into effect in Maryland. So if you go back we had, it was really from April, 2011 to June, 2013, there were actually multiple opportunities for public comment, there were multiple public hearings, this was something that was done through the regulatory process with a very deliberate approach, we modified what we thought was appropriate based on the public comment that we received. I stepped down as the secretary at the end of 2014 so I was secretary through this entire process and in thinking about this and in deciding whether or not this was a risk to public health we had to evaluate both the potential benefit and the potential risk of baby bumper pads. We found no evidence of meaningful benefit at the ages recommended for infants, we'll circle back to that, in fact there was explicit discussion with the, during that industry panel about what is the evidence for benefit and there really was no compelling evidence presented. At one point I think they were asked, is there, do you even believe that babies at this age could exert enough force with their heads to bang it against the side and they said they didn't have any evidence to believe that that was the case. So there was really no evidence of meaningful benefit and there was evidence of potential lethal risk at the ages recommended for infants and so that was the basis of the decision. We also were very, very clear that when we communicated about this we weren't just talking about baby bumper pads because I think crib bumpers I should say, I think a very important point is we're not talking about the vast majority of infant deaths when we're talking about crib bumpers, we're talking about a small number but if the risk exceeds the benefit then you're putting babies at risk needlessly but the big number is generally from a lot of the other safe sleep issues and so we embedded a message about baby bumper pads in the overall ABCs of safe sleep. In fact, I was quoted saying every time alone back crib and D don't use bumpers. So it was always in that context and we really wanted to make sure that this was embedded in an overall sleep message and it didn't stand alone and I think that by the time we were done with the two-year process we had quite a lot of understanding of this and that we had been deliberate and we had looked at the evidence and we considered the benefits and the risks and we went forward without really any problem in terms of implementation. So in terms of follow-up data I think it's important to realize because this is dealing with a small number of deaths generally you're not gonna see major shifts in population-based data but I do think that the best place to look is in Baltimore City in part because they have the most unexplained deaths in infancy in the state in Baltimore. They have a public health focus on sleep-related deaths. They have close tracking of sleep-related deaths and according to the city health department 2015 was the lowest number of sleep-related deaths on record and 2016 looks even better so far. They've said 2015 was also the lowest infant mortality rate on record and the lowest African-American infant mortality rate on record in Baltimore City and we reached out, this is just one of the headlines from earlier this month. This is a letter that Rebecca Danine who has really been the architect of the city's infant mortality strategy submitted to send to me just because I told her I was coming today so we have a copy for you for the record and basically what she said was banning baby bumper pad sales in Maryland was critical to the safe sleep campaign. It reinforces and promotes the messages that babies must sleep alone. Baby bumper pads have been associated with suffocation, asphyxiation young infants and in older infants they're hazardous because infants can use them to climb out of the crib and fall. The safe sleep campaign has been used across Maryland and nationally to prevent infant deaths. It's won different awards and is cited in many places. That's my editorial comment but banning crib bumpers is critical. This is her again to consistent messaging about how infants can sleep safely and reduces just one more risk factor that could result in an infant death. So you'll have that letter for the record. I'm now gonna turn over to Professor Gilan to speak a little bit more generally from an injury prevention perspective. Thank you Josh, it's an honor to be here and have this opportunity to speak to you. Thank you Commissioner Adler and thank you Josh. I'm here today as Josh is, we're here on our own behalf as public health people and not on behalf of the university. But I'm here particularly because when Maryland decided to institute the ban, I was one of the people who wrote a letter of support after reviewing the evidence and concurring with their findings that small but real and unreasonable risk of serious injury significantly outweighs the unproven and lesser benefits of bumper pad use. I am here today to restate that opinion in response to the recent staff briefing package on bumpers. So in addition to that, I wanted to just make three points after having reviewed the staff briefing document, I'd like to share sort of three injury prevention approaches or ideas that I think are relevant to your decision making today. And then very briefly share some preliminary data from a safe sleep program that we're doing in Baltimore. So first on the slide here you see is the precautionary principle. It states that the potential threat of harm, even in the absence of definitive cause and effect relationships should be sufficient for action. And this precautionary principle has its roots in environmental risks, but many of us find it useful for policy decision making and injury prevention. In fact, a world-renowned pediatrician, Dr. Barry Pless, who is the professor of pediatrics and epidemiology and biostatistics at McGill University, as well as director of the injury prevention program at Montreal Children's Hospital and former president of the American Ambulatory Pediatric Association, excuse me, stated that indeed this principle should be the bedrock of most injury prevention efforts. This principle is really relevant to the case of crib bumpers because there are no counter-bailing benefits of their use. The second injury prevention. I may interrupt for just one second just to put a brief comment on the record. I am somebody who likes the precautionary principle but I've always been reminded that that is not the law that governs CPSC action that in point of fact, we do have to cause an effect at least to the extent of showing that a risk is associated with harm to consumers. So just to be absolutely clear, I think this is a very important principle. Someday maybe you can convince our legislature to incorporate that into the Consumer Product Safety Act but at the risk of being a grinch on the point. That is not the principle that governs our action. I should also point out that I don't hear anybody here saying that we should make our decision based exclusively on the precautionary principle. If anything, what I'm hearing is there, excuse me, significant and substantial data that does support a cause and effect relationship. Thank you. It was in some of the work that we've been doing, it was a new idea to me and certainly something that is very relevant to when we think about injury prevention and I certainly take your point about what's possible and what's not possible. So the second point is that the first and best injury countermeasure, and I think you've already made this point, Commissioner Adler, is that is the idea of eliminating the hazard when possible through engineering solutions. And that's why we no longer have draw strings on children's clothing, for instance. And I think the same thinking applies here, which would save countless lives of innocent infants. Third, the last choice for an injury countermeasure should be relying on consistent vigilance by human beings to protect themselves because it's difficult and it's often ineffective. Many injury prevention messages are not understood by large proportions of people because they're communicated without consideration of literacy and cultural issues and many safety recommendations that are understood are simply ignored, forgotten, or intermittently followed because of poor communication strategies and because after all, we're all fallible human beings. When an ethical and feasible alternative exists as in the case of banning unsafe crib bumpers, we should eschew approaches that put the burden for infant safety on parents. If the Consumer Product Safety Commission were to adopt messages that run counter to what every major child safety organization recommends, the burden on parents would be exponentially greater. And finally, I'm just gonna share, I don't have a slide on this because literally it's very preliminary, as in put together yesterday we looked at our data. We have a safe sleep study currently underway in Baltimore funded by the National Institutes of Child Health and Human Development. It's a randomized controlled trial of an educational program compared to the standard of care provided in the Harriet Lane Primary Care Clinic at Johns Hopkins and that clinic serves a mostly African American medical assistance population. And our health educator intervention group is compared, as I said, to the standard of care for well child care. And to date we've conducted follow up home visits to actually observe sleep environments with 118 moms when their babies are about two months old. Concern was raised in the briefing documents that if crib bumpers were banned, parents would put more soft objects in the crib. Of our 118 parents, we had 27 who said their baby had slept in a crib. The majority were sleeping in packing plays or bassinets. So we were able to observe the 27 cribs of which three had bumper pads in them. And 100% of those, or all three of them had other soft objects in them. Blankets, toys, a pillow or a positioner. Among the 24 cribs that did not have bumper pads in them, 50% had other soft objects. So none of the cribs in our intervention group had soft objects or bumper pads in them. So the message was getting to our moms about that risk. And all the cribs that we observed met the standard for the safe distance between the cribs. So while our data do not directly address whether the soft objects that we observed were substitutes for bumper pads and our numbers are small, luckily our bumper pad numbers were really small, probably in part due to the ban, the data do suggest that banning bumper pads and educating families may be an effective strategy to protect newborns. We'll be following up these families again when their babies are four months old and we'll have more data to report on at a later date. So in summary, I believe that when it comes to crib bumpers, the evidence is still on the side of real and unreasonable risk to infants. And we've seen no evidence that the ban in Maryland has resulted in higher rates of other unsafe sleep practices. In fact, the ban may have contributed to the reductions in sleep-related deaths in Baltimore as a result of it taking a comprehensive approach in Baltimore City where we combine the ban with education and access to safe sleep products like pack-and-plays. So thank you very much for the opportunity to share this information and I turn it back over to Josh for his conclusions or our conclusions. Thank you. So we just wanted to make a few comments on the staff document. The first is that the concept of sort of if there are more than one hazard in the crib, then that's not really a kind of a case to be focused on. We did not think had merit. It failed to recognize that many injured us have multiple causes and it's important to think about the fact that you can have more than one cause that doesn't mean that it wasn't in fact contributing. And when we talked about this in front of the advisory panel, this was explicitly considered to be an inadequate way of thinking, particularly the assistant medical examiner was quite focused on the fact that when she's attributing death, she attributes death to more than one thing. That's the practice of doing it. You don't just say, well since it was more than one thing it couldn't be anything. And even if you use that method you still find some cases where the products have caused serious injury. So I think we're both pointing out that it's not a persuasive method even if you do use that method it's still showing unreasonable risk. Second thing is we did not find the attribution of benefit to crib bumpers in that document credible. And at the age of recommended use there's essentially no risk of serious injury from a crib that meets CPSC standards. This was discussed in the staff's analysis they talked a little bit about limb entrapment but didn't even talk about the age where that would happen. When we talked about this at the advisory committee there really was nothing to speak on behalf of injury at the recommended age. And is it possible that older kids who are really moving around the crib could get their limbs entrapped? Could, those kids are at extremely high risk of vaulting themselves out of the crib. In fact most parents, I'm not gonna say most but many parents that I've talked to about crib bumpers what they tell me is that they took them out after their child hit their head the first time because they took a step and fell out of the crib which is a not insignificant risk. But for older kids all kinds of things can happen to them but at the age you're really talking about it's not a significant issue and it doesn't make sense to write that there's a benefit without examining the age issue which is a fundamental failure of the staff document. We multiple times asked our advisory panel whether they found any meaningful benefit and unanimously failed to find meaningful benefit. The last point is on this idea that parents would respond to abandon sales by taking more dangerous action. And this is a concern that I'd heard I was involved as a city health commissioner in petitioning the FDA to remove the market over the counter cough and cold medicines which at the time were used by many, many, many parents. We had an advisory committee meeting at the FDA and the position of the manufacturers was it was a generally similar story by the way there was no evidence of meaningful benefit and there were definitely cases of kids who had gotten into serious trouble and even died from over the counter cough and cold medicine and the companies at the time argued that well if you take away these parents may harm their children in some other way and their big concern was that they would if you didn't have the dropper they would give a teaspoon of the adult and you get more overdoses, you know. And our view was that parents want to do what's best for their kids. They will listen to the rationale. You put it in the right context and you communicate clearly. Parents are not gonna rush out after they hear that something is unsafe and in mass give more of it to their children. It is not a logical thing to do but we didn't know at the time and in the end what happened was that the companies voluntarily withdrew all those products for kids up to age four and since that time there has been research on this question. There have been multiple studies and those studies have not found that compensation that was worried about at those hearings. There have been multiple studies showing substantial declines in poison control calls and emergency department visits. I'm gonna include in my slides here the references for three major papers but it is just unquestionable that that action led to a substantial decline in risk for that population and I think that the concept that there'll be, it'll be even more at risk is a, you can make the argument but I think in general I don't think that is where evidence is how parents react to actions like this. So to conclude, I think that where there's no evidence of meaningful benefit there's no justification for permitting a potentially lethal risk for infants. We think the CPSC should ban the sale of baby bumper pads nationally just as it's been done in Maryland. The ban should be coordinated with public health agencies, child safety agencies and the American Academy of Pediatrics and should emphasize all important messages regarding safe sleep in a consistent and effective manner in order to get the greatest public health benefit from this particular policy. So with that we'll pause and thank you for having us and if there are any questions we're happy to. I do invite members sitting at the table to ask questions or make comments. I do have a couple of quick comments. I was proud to see that the law that you operate under in Maryland is patterned after the Federal Hazardous Substances Act which is a piece of legislation that we enforce and I was reading that and it looked like it matched language that was I think in the 1966 Child Health and Protection Act I'm digging deep into my memory bank to get that but it is so nice to see that we have a common approach. The one observation that you made that really does resonate with me is that merely because other things are contributing to the fatalities, the fact that crib bumpers are also contributing to fatalities is the important point. So I just wanna make certain I emphasize this point and see how you respond to it. It is not the case that you are asserting that there may be a hazard associated with crib bumpers. I think if I understand you correctly, you're saying there is a hazard associated with crib bumpers sometimes by themselves and sometimes in conjunction with betting in cribs but there's no question in your mind but there is a direct causal link between the presence of crib bumpers and children's fatalities. Yeah, let me answer and then I would like Professor Gilan to answer. I think that the evidence from the actual death scene investigations, kids who are strangled, kids who are smothered against the crib bumper, you know, that is evidence that these products are not safe in the crib. I think that where you have the child smushed against the bumper and there's a blanket over their head, you know, I don't think you can say that the bumper has no causal role in that, you know. And so if there's more than one problem, you don't just throw that case out. And I guess I would ask Professor Gilan to comment on that and just in general how attribution is handled in the field. Well, I was looking mostly at the prevention side of the equation and I think the people who presented earlier probably have more comment on the actual death scene investigations to share on that particular point. So, you know, I don't really think I can contribute. Well, the other observation I would make is that we've, years ago when we were first implementing leg regulation that was mandated on the Consumer Product Safety Improvement Act of 2008 and the complaint was that the amount of lead in the kinds of products that we had jurisdiction over toys and other children's products was really minor and that the major issue with lead was, lead left over from the addition of lead to gasoline. But the fact is that as we were reminded constantly, this is a holistic issue. It cuts across all sorts of jurisdictions and so one of the things you try to do is within your area of control to try to control that which you can control. And so I think this is one of those examples where there really does seem to be a causal nexus and I wanted just to put on the record because I had done some research on this. The kinds of circumstances under which the commission has said we have jurisdiction. For example, if you have a medicine cabinet that's manufactured without a lock, the medicine cabinet itself does not attack little kids and is not what is injuring kids. It's the failure of a lock to be there and our general counsel years ago said that we would have jurisdiction in a situation like that. We would also have jurisdiction over fire extinguishers that fail to put out fires. Now the fire extinguisher hazard in that case is not somebody hitting somebody else on the head with a fire extinguisher or it falling on a consumer. It's just, it didn't function when it was supposed to function and that would be a sufficient causal nexus for us to have jurisdiction. And then my favorite example, a traffic light that doesn't signal properly. Not that we regulate them, but we could in an appropriate case even though it's not the traffic light that is directly causing the injury. And I'm not sure if you can please go ahead. Yeah, I'm reinterpreting the question a little bit now. I'm thinking about one of the other things that we always go to is trying to make the safest behavior the easiest behavior. So in the blanket over the baby on the bumper, obviously the blankets have many other functions that are useful and helpful and you're not gonna ban blankets because they have the benefit. And so if anything there is contributing and you can remove the hazard, then you should remove the hazard. We can remove blankets by only educating people about what's their use and how to use it properly. But with crib bumpers, there isn't benefit and we can remove the hazard. So we should do that. So if that's the kind of injury prevention perspective you were thinking of, it finally clicked. I was thinking of all the, you missed all the things we saw earlier. So I was back in those pictures which is not a good place to be. I think that's helpful. I think one of the things that came up in our public comment period and it came up with cough and cold medicines is obviously many, many children took cough and cold medicines or use bumper pads and we're fine. It's not the case that it's, you use it and you have an injury 100%. We're talking about generally rare risks but that's the right questions whether they're real risks and you can absolutely see in a number of different cases that these are real risks to kids. And then you have to say, if you have real risks, a child could die, is there evidence of benefit that over, that justifies that? And in the case of cough and cold medicine, there really wasn't any evidence and that led them to be removed from the market and the world didn't stop spinning at that. Even though many, many, many more parents use that than for longer periods of time than bumper pads, you know, people understood the rationale. It was accepted because there was a serious risk without real evidence of benefit. The benefit question really has to be appreciated and I think the failure of the staff document to do a credible job on benefit is really the weakness of the analysis that's there. I also did want to ask Dr. Galen, the study that's currently underway, when those results are more concrete, I would appreciate it if you would share those with the commission. Absolutely and we will be doing a better job of observing the soft objects from here on out so that we can actually address what they are and whether they are things that parents are using because they think they need them to replace the bumpers that they can't have. We don't have that but we will going forward. And I think the letter from Rebecca Danine is very clear on this. It's a much clearer public health message if you can talk about nothing. It's very hard to say don't put anything puffy in the crib but it's okay to put a humongous puffy thing all around the edge of the crib. It's not a consistent message at all and I think her view is that it's very reinforcing with the safe sleep messages that they've used to dramatically reduce infant death in the city. Do we have any other questions or comments, Dr. Moon? The other thing I just want to mention is that when you have, if you do risk factor analysis with regards to these infant deaths, the risk factors are multiplicative and so the more you have the more rapidly your risk increases. So for instance, if you take out smoking out of the equation then your risk drops. It doesn't drop to zero but it does drop significantly and so when you take out, so when we look at the whole sleep environment we do, if you take out this, if you take out that, all of these things are going to make a difference and for some of the children it will be a tipping point and I think that bumper pads for many children are the tipping point. Ms. Covington. I would just concur with that. When we were looking at our narratives and people were saying, well, what are you gonna do next? Ban pillows, ban adult pillows and you know, because a lot of the babies that we looked at, the cases I showed you rolled off of pillows that were put in the bed but the fact of the matter is they rolled off the pillow into the crib bumper and the crib bumper didn't have a purpose. I mean, well it probably has a purpose but I sort of agree with you that the benefit isn't there in terms of what its purpose is. So if they'd rolled off the adult pillow would they have been all right if they only had rolled with their face against wood slats they may have served on? And that is actually not an uncommon thing in the study that we did using your data when we looked at older babies versus younger babies. The soft bedding was the primary risk in the four to 12 month olds and a major issue was that the babies would roll over or roll off of something into soft bedding and then they could not extract themselves and they died. Yeah, and I would also add an observation that is constantly repeated at the Consumer and Product Safety Commission is that infants like this are totally involuntary risk takers. You can't educate them not to roll around in the crib and expecting parents to take precaution when they look at a crib bumper and they just see something that's warm and inviting and beautiful and the hazard associated with it at least from my perspective is not at all obvious. So one of the things that we're more concerned about is dealing with things that could be labeled as hidden non-obvious hazards. So that sort of adds to the concern that we have. Are there any other observations, comments, questions? Yes, Dr. Scheer. Well, I'd like to talk about multiple causes. When you have a wedging, you'll have two surfaces. So you could have the baby between a bumper and a pillow and you say, well, what's the cause? Well, I don't care if the baby's face is pointed into the bumper or pointed into the pillow. Point is, if you take away one of those surfaces, you don't have the wedging. So if the bumper weren't there, you wouldn't have had the death. Thank you all very much. Thank you for driving out long distance this morning and fitting us into a busy schedule. Ms. Kaus, mispronounced that, coals. You got it right earlier, so I was impressed. Well, I'm so glad and thank you, Commissioner Adler, for having this session. I think it's brought out a lot of good information. My name is Nancy Coles. I'm the Executive Director of Kids in Danger, where a non-profit is dedicated to protecting children by improving children's product safety. Our mission is to promote the development of safer products, advocate for children, and educate the public about dangerous children's products like the bumpers we're talking about today. We were founded in 1998 by the parents of Danny Kaser, who was killed in a recalled portable crib at his licensed childcare home in Chicago. In forming KID, his parents made it their mission to prevent other families from suffering the same tragedy that they did. I really appreciate all the in-depth information we've heard here today. The staff report present a skewed view of the danger, one that has been balanced by the statements that we've heard here today to give a fuller picture. The case against permitting padded crib bumpers in a child's sleep environment is clear. This isn't medicine vital to a child's health that may have some side effects that we must weigh and manage. It isn't a product that serves a useful purpose for safety and that proper education on its use is needed. This is an unnecessary accessory to decorate a nursery that has no place in a safe sleep environment. Industry has attempted to paint this as a safety item, but it is not. By talking about the safety benefits of bumper pads, both the manufacturers and the CPSC staff are saying that a crib, one of the most highly regulated of children's products, is unsafe without an aftermarket product being added to it. And that's a very dangerous message to be giving to parents. We say at KID, we say decorate the nursery, not the crib. Slide three. Oh, thanks, sorry. In our educational materials when talking to parents, KID has always warned against crib bumper pads. Any soft bedding in a crib or bassinet can cause suffocation and have been linked to SIDS. As we've heard, older babies can pull to a stand, can use bumper pads as footings to catapult out of the crib, possibly facing severe injuries from a fall. While most deaths in cribs are caused by suffocation or entrapment, most non-fatal injuries come from falls. When Dr. Thatch published his research in 2007 in the journal Pediatrics, we thought that would put an end to the use of crib bumper pads. He found the 27 deaths over a period of about a decade that were attributable to bumper pads, where babies were found with their face or head against the bumper pad or wedge between the mattress and bumper pad. But unfortunately, crib bedding manufacturers tried to discredit the doctor's research and promoted bumpers as a safe product for cribs. You have heard here today from both NJ Shears and Dr. Thatch again, they've updated the data that shows the same outcome. Bumpers have been involved in babies' deaths. Then in early 2010, kid was approached by two families that renewed our commitment to seeing this product off the market. Slide four, this is Aiden. Aiden suffocated on his crib bumper in Texas. We were contacted almost immediately afterwards by his grandmother. She had purchased the bumper pad herself, led to believe they were part of a safe sleep environment and important to keep her grandson from injuring himself. Imagine her heartache after learning the very thing that she had purchased, thinking it would protect her beloved peanut, as she called him, ended up being what suffocated him as he slept with his mother in the same room, because of course suffocating babies don't make any noise. On slide five, then we heard from the family of Preston Maxwell. Just eight weeks old, Preston slept on a sleep positioner in the middle of his crib. His distraught parents found him one morning. He had rolled off the sleep positioner and it ended up with his face between the bumper pad and mattress. Immediately after Preston's death, the CPSC, along with FDA, led by Dr. Sharfstein, issued a warning against sleep positioners saying they were unnecessary and dangerous. For years that reduced the number of sleep positioners on the market to almost zero. I will say we're beginning to see them creep back in again when we look online and I would urge CPSC and FDA to stay vigilant against this. But no action was taken by CPSC to eliminate the padded bumper on which Preston suffocated. Among children's product safety issues as we've heard here today, a safe sleep environment is an overriding concern. Suffocation, most of it in a sleeping environment is the leading cause of unintentional death of infants. The number of sleep related deaths in infants is too high and it's not showing signs of decreasing except for as we've heard in certain areas. It is a public health emergency. In bassinettes, portable cribs, playards, cribs, or some newly designed product or accessories, sleep products must meet the highest standards for safety. It is the one place we encourage parents to leave a baby alone. Cream bumper pads were developed when crib slats were far apart and there was a risk of a child slipping through only to be caught by the neck and strangle. It didn't work then. Babies still strangled that way and the crib standard changed to limit the space between the slats decades ago, as Commissioner Adler pointed out. But the padding remains. Now as a decorative items that some parents are falsely led to believe will keep their baby safer. Manufacturers point to it keeping baby's arms and legs from getting stuck between the slats. But our review of saferproducts.gov information shows that almost 90% of the reports made of that problem are of babies over the age of six months. When manufacturers themselves recommend the product be removed to avoid a baby stepping on it to climb out of the crib. So, manufacturers seem to be saying that if parents don't heed their warnings, they can keep their baby safe. Which we think is obviously has bad consequences for all kinds of public safety messaging. It must stop the use of crib bumper pads for our vulnerable babies. A bump or a bruise of the leg or even the head is nothing compared to the horror that Preston and Aiden's families faced and others like them face. Six shows a timeline, which I'm actually, we've talked about a lot of it today. I'm not gonna talk too much about it. Obviously the 2007 report, 2010 if you've not seen the report by Ellen Gabler on the Chicago Tribune on Preston's death and other deaths. Chicago, proud to say, became the first, at this point the only jurisdiction to ban all forms of bumpers. ASTM then in response to that passed a standard that limited it to traditional padded bumpers rather than very puffy ones and have tried to use that to stop further state action in other places. CPSC accepted JPMAs proposal on the crib bumper pads. Maryland bans the sale of crib bumper pads and then just this year we had the new report again highlighting that the deaths are growing. Manufacturers, let me go to the next slide. I'm just trying to think, a lot of this has been said. I just wanna also point out that based on the AAP recommendations that we've heard this have just been updated this week and the history of suffocation, almost all hospitals in our country tell parents not to use crib bumpers in the crib. Retailers, Target, IKEA and others have stopped selling them. Almost all childcare facilities are prohibited from using bumpers and it should be noted that childcare regulations in states are often a good place to put best practices into place. We can monitor and regulate what is used in these settings as opposed to in private homes. If it's important for your child's nap at childcare it should also be important at home. As I mentioned, the ASTM standard simply limits bumpers to two inches of thickness which by the way is even thicker than most bumpers currently on the market so they can start making them fatter I guess. Simply means that the very type of bumpers that we know have suffocated children would now be labeled as safe if the CPSC adopted that as their own standard. All right, bear is best, slide number eight. In addition to the direct risk of suffocation from crib bumper pads there's also the issue of contributing to SIDS by reducing airflow in the crib and confusing parents on the safe sleep message that encourages a bear crib. The safe sleep message is a hard one. The messaging is simple and straightforward. Back to sleep, bear is best. Both messages have reduced infant deaths but bear is best runs smack into our intuition of what we think babies need. We even call a mother preparing for her baby as someone who is nesting, surrounding the baby with softness and cuddling them even when we aren't holding them. But that softness and padding is the opposite of how babies sleep safely which is why the sale of padded bumpers not only increases the risk of baby suffocating on the pad itself but of following the lead of manufacturers by adding more padding and softness around their baby. It's hard to convince parents to remove padded items such as pillows from the crib when you're selling them a two inch thick pad to wrap around the crib at the same time. Those in child safety and public health arenas work tirelessly to educate parents on the concept of safe sleep and padded bumpers in the marketplace make it all the harder. Commissioner Adler, you already mentioned that a few weeks ago you participated in our workshop that ASTM and Iqviso did on information education campaigns. We heard about how without changes in design or regulation, education has little effect. Every day, parents are bombarded by pictures like this in the media. These are just, took me about a minute to find all of these online. And as new parents consider what they need for their nursery, registering, picking out all the wonderful things they want, these pictures didn't show up as clearly but they can come across hundreds of these both in stores outside of Chicago and Maryland and online. As long as bumpers are still on store shelves, they will continue to be used despite every health and safety organization warning against their use. We've heard a lot of compelling information here today. I know the debate will continue despite that. But I urge you to protect our most vulnerable consumers from this unnecessary product. As we said, we thought in 2007 that data would be enough to compel us to stop selling this product. I was wrong then but I hope that CPSC will take this action now almost a decade later. Thank you. Thank you very much. I invite any comments now at this point from those who have participated in today's discussion which I have found extraordinarily enlightening and very educational so I invite comments, Ms. Covington. I actually was at the AP release the other day and I asked the question about mesh bumper pads because we've heard people trying to discuss, trying to present them as an alternative without the padding. And I know the AP has some reasoning. Rachel, you sort of touched on it in your paper but can you expound a little more on what the hazards are with the mesh bumpers? We don't know what the hazards are. There aren't any data on them. But our reasoning is that we don't see any benefit to them either and so why put unnecessary stuff in the crib when you don't need them? Unless there's compelling evidence that there is benefit, I don't see that why we would want to put them in the crib. Yes, please do. How we handled that in Maryland because it was not in our original proposal but we in the end focused on non-mesh pads for the and the way we explained that publicly was that we felt like we had evidence of meaningful risk to kids from the non-mesh ones. We weren't at all recommending the mesh ones. We said that publicly. We think the best thing was nothing but the threshold for us to take an action like actually banning the sale was similar to what you said before. Commissioner Adler was evidence of harm and we felt like the evidence of harm was very clear for the non-mesh. Yeah and that indeed is a challenge for CPSC. I wasn't at Carl Sagan who said absence of evidence is not evidence of absence. It's one of my favorite expressions but it's a very insightful point. I wish that were the case for what regulates what CPSC has the authority to act on and doesn't have the authority to act on and this would be, and I'm just speaking for myself, this would be an instance where we would need some kind of evidence, even engineering evidence, if not epidemiological evidence at least from my perspective for us to take action and that's where I'm hopeful that we can get some data that will help resolve the question one way the other. If I could just say on that too because we've dealt with this obviously, we have not passed a ban in Illinois but we have talked about it and we also started similar to Chicago banning all products because we do believe they're useless. There's no point in having them but we did end up compromising on that. With the caveat and I would give the same caveat to CPSC is we need to get that data. We need to monitor it closely. If we do see, even if you go a direction where you allow the mesh or something similar for whatever reason that you follow that very closely so that you're not unnecessarily putting other children at risk. If they're used more, would we see additional risks? We just don't know. Dr. Scherz. Yes, Mr. Adler, I have a comment on mesh bumpers. Thank you, Dr. Scherz. Yeah, our granddaughter we had kept sticking her legs or arms out through the rails and would yell and cry and scream and got everybody in the house up. So I thought maybe a mesh bumper would be the thing to prevent that. Another thing is mesh bumpers have been on the market for I guess, I don't know, three or four or five years and how long are we going to go without any report of incident before we can say that they are okay to use? That's a great question and that's the sort of thing that I know AAP is thinking about and other jurisdictions are thinking about and that it's a very important question. And I thought you were going to relate to an anecdote about your, is it your granddaughter? Yeah, granddaughter, great. And I'm sorry, this just triggers one of the things that I was always impressed on me in terms of assessing data and that is the plural of anecdote is not data but sometimes a number of anecdotes can add up to meaningful data. Good. Delay, other questions or comments? I actually had a question for Ms. Coles. I'm wondering if you could talk a little bit about where bumpers would fit into a 104 given that you have expertise on that issue. Sure I do and I'm actually not sure how many people know that the section 104 that was written into the 2008 law was actually initially drafted between Jan Czakowski and myself when I first started working at Kidd back in 2001. As you know, as I mentioned, Danny was killed in a portable crib in childcare. His parents were shocked as most parents would be to find that there was no requirements for testing for safety for children's products before they were put on the market for that particular product. There wasn't even a voluntary standard at the time and really felt as we've said here today that's not what parents think. Parents think if it's on the store shelf it's safe. Someone's made sure it's safe and so we drafted those 104 rules to put in place third-party testing and mandatory standards for those products, not just relying on the industry. As it's developed, that initial list that was in the 104 were products for which there were ASTM standards at the time and so when it was adopted, CPSC rightly added other products to that that also pose similar risks and had the same expectation of parents and we think that crib bumpers like many other products that we've added to that fit right in there. It is a product that's being used. We obviously would prefer a straight band. I think that that's the cleanest thing to do but if we can write a standard such as we've done with bath seats that has, we wrote a very strong standard and no one can make them and so they're effectively banned even though it wasn't official ban. I think it would fit very well within the 104. Can I just follow up and ask, do you have any concerns or how would you address concerns about whether a bumper fits within the definition of a durable infant product? It's really not that different from other products that are already there. So we have slings which minus the padding, some of them, most of them are just a piece of material and we also have things like the nap nanny that was recalled but replacement products for that that are padding covered with material that are used to provide an inclined sleep surface for a child, same materials as the bumper so I don't see why they wouldn't fit in. And of course, those of you who watch the commission discussion addressing crib bumpers about a week ago, I did have an anecdote to relate and I still remember it vividly looking out the window of our apartment and seeing my wife's parents drive up with a trailer that had in the trailer a crib that was many, many years old and had very wide slats and the bumpers and so over my strong objections we put our child in the crib with the bumpers but I was just thinking those things must have been 25 or 30 years old and they were handed down from generation to generation. It's pretty hard to look at those and say they're not durable over time and it's impossible to look at them and say they're not infant products. For me, the toughest question is how do you draw a line between the products that are clearly infant products that last for generations which I would include as sheets and blankets and pillows. I'm not for the moment suggesting the commission is gonna write standards on section 104 but the easier question is at least for me speaking only for myself that they are durable infant products. It's a process of excluding others that from a certain perspective would fit in the same category. Dr. Sharfstein. I have a question for Nancy. In the cough and cold medicine, one of the things that was really striking was how much parents thought they were doing the right thing for health for their kids and a lot of the advertising around those products was so you can sleep too, everyone needs a good night's sleep. It was very much and part of the unfolding of that issue was people coming to realize that it actually wasn't something they were doing to help there because I just wonder as you have worked on this issue is your perspective that parents see, do parents see these as purely decorative or are they assuming they're doing something or are some of them assuming they're doing something healthy for their children? Yeah, I think it's a mix. I think most people, if they're on the store shelves, I mean, you picture how new parents buy things, right? It's not how, oh, I need this, I'm gonna go to the store and get it. It's like, I have no idea what I need. I'm gonna go to the store, whatever's on the shelf, I'm gonna put on my register, I'm gonna think that I need it. So they think that there's a need for it. They definitely buy it for decoration, but I think they're sometimes led to believe, as we've heard today, that there's safety benefits to it and yet there clearly aren't. In the other question from the world of FDA, is that, for example, on dietary supplements, people generally overstate what they think the level of regulation is for something, but if it were really so harmful or you really had this potential, how would it be on the market? Do you have a sense that there's an assumption about that with parents? I know there is. I mean, I know parents I talk to and Linda and I often relay the story. We'd say to people, I know there's no requirements, products be tested for safety and they would base, oh no, that can't possibly be true. They just don't believe it because we feel like we're so over-regulated and yet these things are not regulated. Even today, the products that fall outside of the Section 104 rules, you can still, someone can, they're up late at night with a baby and this is where we see the worst products is around sleep because you really do just wanna get some sleep so they're willing to try all kinds of things and someone had a good idea, worked for their kid, that's how the NAP Nanny came about and now six children have died, five of them on bumper pads involving the NAP Nanny and people just, they bought it, assuming it must be tested to be safe. Commissioner Nader, this is, I just wanted to add a couple of points to some of the discussions today. I would echo what Nancy said with regards to Section 101. This is Ami Gidea for the people who are listening to the discussion. I would echo Nancy's point about Section 104 being the right place for commission action or the ability to address it through 104. We still think that the ban is the way to go but products are gonna come up over time and they're gonna continue to grow, the market's gonna continue to innovate but if the CPSC is to be a nimble agency and the statute's to be a living statute that protects consumers against the real risks out there, then it has to be envisioned as growing with reality. And to, you know, your example of your in-laws coming up, Commissioner Adler, with the crib from your wife's days as a child with the buffers on it and even Dr. Thatch's mention of the example with mesh liners, you know, I think that goes to Dr. Sharfstein's point earlier that you're gonna have a lot of individuals that are having safe experiences with certain products but given the tremendous risk that does exist and the lack of benefit, it lays clear the need for a standard. Are there any other comments, Dr. Moon? I just wanted to say everybody thinks that what they're doing is safe until something bad happens and then that whatever was safe is all of a sudden a respecter. Ms. Covington. I would also just urge some caution in looking at older data and trying to compare it with current data in terms of what we're finding from investigations that are done in the field by examiner, I mean, in death investigators because I just think it's important to remember that death investigations are getting increasingly better. There's people are starting to across the country use the CDC's infant death investigation tools, they're starting to do dowry and eczema and we train on it, we get requests from states all the time and I think as time goes on we're gonna see more of these actually because we're doing better investigations. I was surprised at seven just since, you know, probably in a year. So without trying to pin you down and make it into a statistically representative sample, is it your impression that with more scrutiny and more examination that we're finding that some of the things that previously we might not have attributed to crib bumpers we now do? Oh yeah, I mean, when I first started this work, those, a lot of those would have just been called SIDS without any discussion. I mean, 15, 20 years ago, I sat at many, many, many a child death review team where a policeman or a death investigator was on their way to a scene and they were called back because they were told the baby had died in their sleep and it was SIDS and they didn't even go to the scene and that practice has really, really shifted. Any last comments from anyone here? We can't thank you enough for leaving your busy lives and coming here to share this information and as I say, I'm just one commissioner but I promise you that I will take the recording of today's remarks and the data that you've submitted and make sure that it's made part of the record for the impending section 104 rulemaking that the commission voted on a week ago. But this is just an incredibly valuable point of input for the commission and I think it'll help round out the record before us. So with that, I'm sorry. Yeah, well, thank you all and with that, we will call this meeting to a close and again, we thank you. Thank you.