Good morning everyone. Welcome to this public meeting. Can you hear me? Welcome to this public meeting of the United States Consumer Product Safety Commission. Before we begin, I want to confirm that our AV setup is in place and we have Commissioner Kay connected by phone. So let me ask Commissioner Kay, are you out there? I am. Thank you, Mr. Chairman. It's a pleasure to hear your voice. As I understand it, you cannot be here in person today because you're recovering from a medical procedure. We are thrilled to have you participating by phone and hope all is well on your end. Thank you. Today's meeting provides an opportunity for a public comment on CPSC staff's draft safety standard for crib bumpers and liners. On September 4th, 2019, the commission was presented with a draft NPR or notice of proposed rulemaking for crib bumpers that incorporates by reference the most recent voluntary standard with significant modifications intended to strengthen the standard. This is a project, to say the least, that has been years in the making and I commend staff for all of the hard work, dedication, and collaboration that went into it. To say the least, this is a project that is not without controversy and that's why we're here today. We've heard from a number of safety advocates, including the American Academy of Pediatrics, who caution against the use of crib bumpers altogether and several jurisdictions, including the state of Maryland, who banned their sale. For this reason, the commission decided to take public comment on this NPR before making a decision whether to publish it. This forum is intended to provide an opportunity for comment on all sides and on that note, I would point out that CPSC staff was invited to present testimony today, but declined to do so, which is perfectly fine, indicating that staff's position on crib bumpers is reflected in the staff briefing package. That said, let me reiterate that we greatly appreciate all of the hard work that our very talented staff has put into the package. Today, we're here to listen, to ask questions, and to try to understand the concerns on all sides of this hotly contested issue. Disagreements can often feel personal, but in this case, they really shouldn't be. I believe CPSC staff and everyone in this room shares the same goal of protecting the health and safety and well-being of children. With that said, I urge everyone to keep an open mind and to proceed in good faith. We're going to have three panels today. I'll ask the panelists to introduce themselves, and each one will have up to 10 minutes to speak. We'll then have 10 minutes for each commissioner to ask questions of the panel. We plan to take a lunch break around 12.45 p.m. after the completion of the second panel. In order to stand schedule, I'm going to have to enforce the time limits for both panelists and commissioners, including me. I'll do my best to let each witness complete a final thought, but I apologize in advance if I have to cut anyone off. So our first panel is Dr. Sharfstein, Dr. Moon, Dr. Hoffman, and Executive Director Nancy Coles, and Dr. Sharfstein. I invite your comments. Thank you very much, Acting Chairman Adler and the other commissioners. I really appreciate the chance to be here today. My name is Josh Sharfstein. I'm a pediatrician. I'm a professor of the practice in health policy and management at the Johns Hopkins Bloomberg School of Public Health. I'm the former Secretary of Maryland's Department of Health and Mental Hygiene. Maryland, as you mentioned, is one of the states that have banned the sale of crib bumpers. We did this in 2013. I think we were the first state to do so. I just want to talk a little bit about that and then go to the questions that you posed. We did that not because we woke up in the morning and decided to ban the sale of crib bumpers. We actually engaged in quite an extensive process of consideration. This included a convening and advisory group of public health and pediatric experts in Maryland twice, including the chair of pediatrics at Johns Hopkins and some of the other leading pediatricians in the city. These experts voted twice to advise the state to do a ban. We also had a hearing that provided the manufacturers of crib bumpers the chance to make its scientific case and have an exchange with the experts. After that, they again voted to recommend a ban. We also had two public comment periods where we received a bunch of comments from a range of people where they expressed their views about this. That led up to quite an extensive document that we will submit as part of the record that explained everything that we looked at from the scientific literature, all the public comment that we got in both public comment periods, the hearings that we did. Based on that, we concluded in Maryland that there were known risks of these products, that they were rare, but that they were real. We also found no meaningful evidence of benefits that would justify these risks. As a result, we concluded that a ban was required to protect young children and we will have more information, as I mentioned, submitted for the record. That is my primary experience with this issue. Based on that, I wanted to turn to the questions. One of the questions you posed was about the utility or benefit of crib bumpers. This was something that we explored. I have also worked at the Food and Drug Administration as the Acting Commissioner and Principal Deputy. A key question for FDA is the benefit versus the harm. What is the balance there? You really have to ask the question about the benefit. We did not find any meaningful evidence of benefits from these products, nor did the industry at the time present any evidence, nor do I see any credible evidence of benefits in the proposed rule that is the subject of this hearing. I was kind of looking for a section that says here are the benefits, but from my perspective, you're always thinking about the risks and the context of benefits like you would for medicine. Medicine can cause a serious problem, but is it saving lives too? What's the balance? There's nothing on one side of the ledger that is compelling. At the same time, there are multiple studies documenting injuries and even deaths from crib bumpers. In Maryland, we had a lot of testimony and engagement of the Office of the Chief Medical Examiner where he had found that one death was directly related to crib bumpers and he expressed concern about the role of restricted air circulation in other infant deaths. In the proposed rule, it looks like CPSC has identified as many as 83 deaths of infants related to crib bumpers, and so I think there's an important principle in product regulation for young children where there is no evidence of benefit we should not accept a risk of death, where there is no evidence of benefit we should not accept a risk of death, and that is the principle that FDA used to work with CPSC to get rid of certain infant sleep positioners, no evidence of benefit risk of death. It's the same principle that FDA applied for cough and cold medicines for young children which are now off the market for kids under four and had caused deaths and there were no evidence of benefit. So where there is no evidence of benefit, you should not accept a risk of death for young kids. The second question is about consumer understanding, and here the question that you pose is kind of a subtle one, which is whether the bear is best messaging would include crib bumpers? Is it confusing? I'm not aware of direct data about that question. I think the AAP has taken the position that the continued sale of these products undermines safe sleep messages, and you'll hear from the AAP. There was, but we, I do want to let you know we will submit this for the record, but I've been working with Professor Andrea Gielin who is a nationally recognized expert in injury prevention from the School of Public Health, and she got from the Harris Omnibus Group a nationally representative poll. She got the results yesterday. I'm going to tell you a couple of the findings and we'll submit a report as part of the record. It surveyed 2038 adult respondents weighted to the entire U.S. population, including 144 parents of children, zero to two years. 64% of the parents of young kids reported having used crib bumpers. So these are products that are still being used, and the two thirds of them said that they thought the bumpers were safe. Half to 60% assumed that people wouldn't be able to buy crib bumpers if they were dangerous, and I think that that's a pretty important finding because it relates to this that I think, like, people assume that if something is being sold for the crib that somebody has looked at it and said it's safe to put in there, and I think therefore having them on the market does undermine any message about not using them. If the vast majority of people or at least the clear majority of people believe that just because it's on the market it is safe to use. The third question you asked was about state laws, and I am pleased that the Attorney General of Maryland submitted comments for the record here. The Attorney General's view is that the CPSC rule would not preempt what Maryland does, but the Attorney General also said very clearly that they don't want to be litigating this with anyone. They think if the commission is going to go forward it'd be very important and helpful to put a clear non-preemption provision in the rule specifically. I'm not a lawyer, so what I can say is any kind of preemption would be terrible. A CPSC standard that brings crib bumpers back to the market in Maryland would risk the depth of infants. Maryland has reached historic loads in infant mortality since we put our ban into place. It was one of many factors, I believe, but it makes no sense for a federal agency charged with the protection of young children to be making it harder for states to do its job to protect young children, particularly when a state like Maryland did such a thorough process with national experts governing our decision-making. Notably, Maryland's regulation provides the opportunity for the Secretary of the Health Department, my position, to rescind our ban if CPSC determines that the benefits exceed the risks. But that's not what the proposed rule does, and I want to turn to that as the next point. The proposed rule does not say the benefits of these products exceed the risks. The proposed rule applies a different standard. It doesn't apply the unreasonable risk of injury standard, which is the—I thought was the standard that the CPSC was supposed to apply. It doesn't say does the benefit exceed the risks. It says, can we possibly make these safer than the industry standard? Now, there's a legal question, and the Attorney General of Maryland feels that that may not be the right standard to apply at all. From my perspective, it doesn't make sense because that's a standard you would apply to something that's an essential product. Cars. You need cars. Cars are unsafe in all kinds of ways, but let's make them safer. And the part of that law that that's from is like cribs. You need cribs. Let's make them safer. If you can make it safer than the industry standard, that makes sense. But nobody needs crib bumpers. And so to apply that part of the law to this doesn't make sense. To apply a standard that would be, can we make this a little safer than the industry standard as opposed to is this safe? Do the benefits justify the risks? Is this an unreasonable risk? Those are better standards for a product that's not necessary. And so this actually wouldn't trigger the Maryland provision because it's not a determination that the benefits exceed the risk. It is a sort of a different standard that in my opinion doesn't make sense from a public health perspective. From the Attorney General's perspective doesn't make sense as a legal perspective. The last point that I wanted to make was about warnings. It seems like the major focus of the rule is the warnings. There is a lot of evidence that consumer warnings aren't that effective. Harvard Business Review recently wrote that the answer was a resounding no for whether it was effective. I found this particular warning to be confusing with six different instructions kind of packed in, and I go through a few other things in my written testimony. I want to mention that in our survey, less than half of the parents was zero to two year olds, so they always read the safety information. So less than half. So I think relying on warnings as a principal means of keeping people safe is not right. If something is fundamentally unsafe, it shouldn't be sold, particularly for young children back to the major principal. And in fact, we asked that question to parents. So I would just want to conclude by reading exactly what we asked them. We said, if experts determine that crib bumpers have been linked to the death of some infants, do you think it would be a good idea or a bad idea for the government to stop them from being sold? I think that's the question we have. I don't think there's any question about whether they've been linked to the death of some infants. That is the CPSC's finding. That's everybody's finding. In answer to that question of all adults, 63% said it would be a good idea. 10% a bad idea. The rest were unsure. Of parents of kids under two, 68% said it would be a good idea. 14% would be a bad idea. More than four times the number said good idea compared to bad idea. Dr. Sharfstein, please conclude your remarks. That is the conclusion of my remarks. I think they're right. Thank you very much. Dr. Moon. Good morning. Thank you for allowing us to be here. My name is Rachel Moon. I'm the Harrison Distinguished Teaching Professor of Pediatrics and the Division Head of General Pediatrics at the University of Virginia School of Medicine. I've spent over 25 years studying infant mortality, safe and unsafe infant products, and sudden unexplained infant death. I previously done occasional work for the CPSC as a paid outside consultant on consumer products designed for infant use since 2012. I very much appreciate your invitation to speak to you today regarding the safety of crib bumpers. I'm speaking here today on behalf of the American Academy of Pediatrics or AAP. I'm the Chair of the AAP Task Force on Sudden Infant Death Syndrome. The CDC estimates that every year in the U.S. there are approximately 3,600 U.S. cases of sudden unexpected infant death or SUID. This includes sudden infant death syndrome, accidental suffocation or strangulation in a sleeping environment, and other deaths from unknown causes. Infants are uniquely vulnerable in their early stages of development when immature cardiorespiratory or arousal systems can lead to a failure of the protective responses that older children exhibit. Because of these developmental differences, a sleep environment that is perfectly safe for an older child can pose potentially fatal risk to infants. Safe sleep guidelines as outlined by the AAP require placing babies on their back on a separate surface on a flat firm surface with no loose fabric or soft bedding nearby. While much progress was made on SUID early in the efforts of the AAP and governmental partners like the CPSC in promoting safe sleep practices, we've seen this progress in reducing SUID plateau for the past decade, and actually they'll pass two decades. In some high-risk groups, the rates are actually going in the wrong direction. The CPSC is in a unique position to help address the public health problem of SUID through its jurisdiction over infant products. The AAP has called on CPSC to reduce the hazard posed by certain infant sleep products and to use its position to promote improved understanding of how best to promote safe sleep among high-risk infants. The AAP warns against the use of many different kinds of soft bedding, largely because of the risk of accidental suffocation, entrapment, and strangulation. While the peak age range for SUID is between one and four months, newer evidence shows that soft bedding continues to pose hazards to infants who are four months and older, and is indeed a predominant sleep-related death risk factor for this age group. CPSC data show that pillows are associated with many accidental suffocation incidents when placed under or close to an infant. Quilts, comforters, sheepskins, and other soft bedding have also been associated with an increased risk of sudden infant death. Therefore, the AAP recommends that infant should be placed on a firm sleep surface covered by a fitted sheet with no other bedding or soft objects to reduce the risk of SIDS and suffocation. As the AAP and the CPSC have said many, many times, bear is best. This is why this form on crib bumpers is so important. Bumper pads have been implicated in injuries and deaths attributable to suffocation, entrapment, and strangulation. And with new safety standards for crib slats, which the CPSC established several years ago, crib bumpers are no longer necessary for safety against head entrapment. So in 2016, the AAP Task Force on Sudden Invent Death Syndrome released its most recent recommendations for a safe sleep environment for infants, and these updated recommendations reiterate unequivocally that bumper pads have no place in a safe sleep environment. Their continued presence in the marketplace jeopardizes the clarity of AAP and CPSC messaging on safe sleep and puts infants at unnecessary risk. In the past, we've strongly disagreed with CPSC staff findings that the risks of bumpers do not outweigh the benefits. We believe the benefits to be non-existent, particularly if the bumpers are used at the manufacturers intend, and we believe that the risks are substantial. Dr. NJ Shears and Dr. Bradley Thatch, who will testify later today, they conducted a case series using 1985 to 2005 CPSC data and found that deaths attributed to bumper pads occurred as a result of three mechanisms, suffocation against a soft pillow-like bumper pads due to obstructed airway or rebreathing of expired air, entrapment between the mattress or the crib and firm bumper pads, and strangulation from the bumper pad ties. However, a 2010 CPSC white paper that reviewed the same cases concluded that there were other confounding factors, such as a presence of pillows and or blankets that may have contributed to many of the deaths in this report. The white paper pointed out that available data from the scene investigations, autopsy's law enforcement records, and death certificates often lack sufficiently detailed information to conclude how or whether bumper pads contributed to deaths. Three more recent analyses of CPSC have also come to different conclusions. The two most recent CPSC reviews concluded again that there was insufficient evidence to support that bumper pads were primarily responsible for infant deaths when bumper pads were used per manufacturer instructions and in the absence of other unsafe sleep risk factors. However, Dr. Shears and Dr. Thatch in their reanalysis of CPSC databases, which was published in 2016, found that the rate of bumper pad related deaths had actually increased. Although they recognize that changes in reporting may account for at least part of this increase, they also concluded that 100% of these deaths could have been prevented if the bumper pads had not been present. We thus have significant concerns with CPSC determinations about the risks of bumpers in the face of this growing evidence. Other products such as mesh crib liners and crib slat covers attach to crib sides or crib slats and claim to protect infants from injury. However, there's no published evidence that support these claims, and the risk of suffocation may outweigh any minimal safety benefit. We pediatricians are fond of saying that the absence of evidence is not evidence of absence. So without published peer review data demonstrating that other products that attach to crib sides or crib slats such as mesh crib liners and crib slat covers do not pose a potential for suffocation and trap motor strangulation, these products cannot claim to be safer alternatives to crib bumpers, and the AAP does not recommend their use. So we urge CPSC to look to peer review data in making these and other safe sleep assessments. The CPSC's own website states that the CPSC is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency's jurisdiction. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard, unquote. A ban on crib bumpers unequivocally meets the standard admission, crib bumpers are associated with deaths, and they pose a mechanical hazard to infants. In addition, they are not an essential product, so their dubious benefit is far outweighed by the clear and present risk. But rather than recommending a ban on bumpers, the CPSC staff briefing packages repeatedly seem to take the stance that unless death occurs in association with a crib bumper in the absence of any other risk factor, they will not recommend action on crib bumpers. This is not the agency's mission, this is not how pediatricians look at safe sleep, and this is inconsistent with best practices and public health. On the contrary, when determining the safety of a sleep environment, we look at the totality of the circumstances. We ask if anyone of the parent smokes, we ask if anybody is the baby's breastfeeding or formula feeding, and we ask if the family is bed sharing. We understand that illumination of each risk factor can contribute incrementally to sleep safety. The presence of crib bumpers is one of these risk factors. We also understand that the CPSC has to look at the overall impact of any action. For instance, it is impractical to ban all salt beddings as other population groups besides infants use salt bedding. However, crib bumpers are supposed to be used only by infants younger than six months of age. Therefore, we believe that a ban would have little or no negative impact on the rest of the population, but would have a tremendous positive impact on infant sleep safety. If crib bumpers, as they are being used by consumers, whether in cribs with infants with colds or with other salt bedding or sleep positioners, are involved in one infant depth after another, the way to protect the public is to disallow their youth used not to contort reasoning to permit the use of crib bumpers. The staff package states clearly that, quote, salt bedding is a suffocation hazard, unquote, despite its ostensible purpose of keeping an infant warm. However, the staff package does not support a ban on crib bumpers, even though they pose the same hazards as salt bedding because CPSC staff say that bumpers ostensibly serve the purpose of protecting infants from limb entrapment. This is logically inconsistent, confusing to consumers and deadly for infants. A ban on crib bumpers would reinforce the message that bear is best. No salt bedding of any kind should be placed inside an infant's crib. There is one surefire way to prevent infant deaths from crib bumpers. Don't use them ever. The AAP therefore reiterates its request to the commission to ban crib bumpers without delay. Thank you again for the chance to testify today, and I look forward to answering your questions. Incredible. You made it with one second to spare. And I did want to point out that we have lights that go on the yellow and the red. I don't think Dr. Sharfstein could see it because maybe the computer was blocking it, but we do move to the light system. Dr. Hoffman, your testimony, please. Thank you so much, acting chairman Adler and commissioners Feldman, Biako, and Kay, and absentia. We hope you get well soon. My name is Ben Hoffman. I'm a professor of pediatrics at the Oregon Health and Science University in Portland, Oregon, and I'm here on behalf of the American Academy of Pediatrics, where I currently serve as chair of the Council on Injury, Violence, and Poison Prevention Executive Committee. We deeply appreciate the opportunity to participate in this important forum on crib bumpers. I recognize freely that the plural of anecdote is not the truth, but I want to start with a story. Two days ago on Monday down the street from my home is a pottery barn kids. I have not been in there previously because my kids are all old. But I took the liberty of a nice day in Portland with no rain to walk down the street. I went in and talked with one of the sales people with the understanding that one of the staff in my office was pregnant and we were thinking as a group of getting together and purchasing a crib for them. And I was shown a number of different cribs each equipped with a big fluffy blanket and crib bumpers. And when I asked about the bumpers, we're told that they're necessary to prevent injury, that there are government standards around them, that they've been proven to be safe, and they could not be sold if we knew that they weren't safe. This is what I was told. An increasing number of unregulated sleep products that provide no added safety benefit to infants and in fact pose a real risk for suffocation can be found on the market. These include soft objects like pillows, pillow-like toys, quilts, comforters, sheepskins, sleep positioning products, and loose bedding including blankets and non-fitted sheets that can obstruct an infant's nose and mouth, posing a risk of suffocation, entrapment, or SIDS. As a pediatrician who specializes in injury prevention and safe sleep, I'm concerned by the proliferation of these products that are not only unnecessary for safe infant sleep, but in fact dangerous. As Dr. Moon said, the AAP is long recommended against the use of crib bumpers which have no place in a safe sleep environment. The data clearly show that bumper pads and similar products attached to crib slats or SIDS are frequently used without the thought of protecting infants from injury or sorry with the thought of protecting infants from injury and indeed bumper pads were initially developed to prevent head entrapment between crib slats. However, based largely upon your work in the 2011 standards that required crib slats spacing to be less than two and three eighths inches, head entrapment is no longer a risk and padded crib bumpers are now completely unnecessary. These products provide no benefit, pose a real and present danger in many of the nation's infant sleep environments and should be eliminated. Researchers have concluded that at best the use of bumper pads may only prevent minor injuries. There is little to no data on the extent of those limb and head injuries, but knowing what we know about child development and physiology as a pediatrician, I'm certain they would be only very minor. Any potential benefit in pretending, preventing minor injury with a bumper pad are far outweighed by the risk of serious injury or death. Again, this can occur due to entrapment between the mattress and crib bumpers, strangulation from loose ties or other parts of the product, suffocation when an infant's head is pressed against the product, compressing the nose and mouth and obstructing the airway, and asphyxia when an infant's position on or near the product leads to rebreathing expired air. Qualitative research with mothers of infants have found that the primary reason that parents purchase crib bumpers is that they exist. They're cute and parents often mistakenly believe that crib bumpers will prevent serious injury, mostly regarding fears about head trauma and limb entrapment. Regarding the risk of head trauma, I'd like to spend a minute thinking about physics and I apologize for this in advance. We know that force is equal to mass times acceleration. The force needed to incur major head trauma, such as a concussion, requires a large mass, large acceleration, or both. The 50th percentile for weight for a six-month-old infant is 6.5 kilograms or approximately 14 pounds. I'm using that example because six months is the point at which crib bumper manufacturers would recommend not using a bumper, but a six-month-old is going to be the oldest and largest mass infant who likely would be using it. An estimate of the force required to sustain a concussion is approximately 95 Gs, which translates to 931 Newtons, which is the universal unit of force. For a 6.5 kilogram infant to sustain 931 Newtons of force to their head would require they hit the crib bumper at a speed of just over 29 miles per hour. I argue that it is impossible for an infant not being shot out of a cannon or something along those lines to sustain that force within a crib. I think we'd all agree it's out of the realm of possibility. The second concern that parents often have is limb entrapment, and this was something that was discussed by the salesperson with me. The majority of entrapments that occur are reported after the age of six months, which is past the age at which crib bumper should be used. Developmentally, we know as pediatricians, most infants begin to roll over some time between four to six months of age and pull to stand by nine to 12 months of age. These mortar skills are prerequisites for limb entrapment, and therefore if the product is being used according to manufacturer's instructions, it shouldn't even be in the crib when entrapment is a risk. Even if we can consider their use after the age of six months, I think we'd all agree. Although entrapment at this point may cause some momentary distress, and I as a pediatrician recognize the impact that an infant waking can have on both the infant and the family, I would take an entrapped limb with minimal to no injury and some inconvenience over SIDS or other catastrophic event any day. Crib bumpers are wholly unnecessary for a safe crib, and the real and substantial risks of death outweigh any minor to negligible safety benefit. We support banning crib bumpers federally as several state and local jurisdictions have already successfully done. Education and intervention campaigns are often effective in altering practice, and pediatricians continue to engage in these campaigns. Since the 90s, concerted education efforts by the CPSC, AAP, and other partners have led to tremendous progress in decreasing infant sleep-related fatality. The CPSC safe sleep awareness campaign has been a very useful tool for pediatricians seeking to help parents understand what constitutes a safe sleep environment for babies, and we're very glad that this information exists in both Spanish and English. The commission should definitely continue its work in promoting safe sleep behaviors and removing unsafe sleep products from the marketplace, including working with other federal agencies and stakeholder groups, including the AAP. However, our warnings about crib bumpers are frustrated when the CPSC's own messaging on bumpers is muddled at best. Most parents are aware now that babies should sleep on their back, but fewer than 50% are aware that babies should not sleep with soft bedding. We believe this is largely because of the confusing messages that parents receive by seeing bumpers available for sale, as I saw. They see advertisement after advertisement for cozy bedding, including crib bumpers, and they believe that they are not good parents unless they provide a soft, comfortable sleep environment for their infant. Unfortunately, these good intentions often end up being deadly. We believe that when crib bumpers are available for sale, it confuses the safe sleep message for parents. I cannot tell you how many times I've heard from a parent the belief that if they sell them, they must be safe. A surprising number of parents believe there's an agency out there that tests all infant products before they're sold to make sure that they're safe. In other words, an FDA for infant products. As you know, that agency does not exist. We understand the CPSC is not a proactive agency that tests products before they're sold, but a reactive agency that alerts consumers to problems with products that are already on the market. However, we're not talking about a theoretic risk. We're asking you to prospectively address, but one with data demonstrating its fatality risk and making plain the importance of decisive CPSC action. In just the past year, we've seen the consequences of products that are marketed and purported to be safe for infant sleep, but run contrary to safe sleep guidelines. Popular infant inclined sleep products like the rock and play sleeper were recalled, but only after over 70 infants deaths were identified associated with the products. Tragedies like that are preventable and you play a crucial role to provide regulatory oversight to protect infants from sleep-related products that are not safe for sleep and pose a fatality risk. We have a letter that has currently been signed by 41 organizations that we will be submitting and it will be signed by many more before it time is up to the Consumer Product Safety Commission to remove all crib bumpers and liners from the market to protect infants and families. We'll submit this letter as a written comment to the record. I thank you very much again for the opportunity to come and address you and I look forward to answering your questions. Thank you very much. Ms. Coles. Thank you. Thank you for holding this forum, for inviting us to testify. I think that it's a very important topic and we appreciate the opportunity to get this high level of expertise and experience in the room together.  Their work has kept many children safe and I think hopefully if we can get these padded bumpers off the market we would move even farther ahead. The case against permitting crib bumpers in a child's sleep environment is clear. As has been said this isn't medicine vital to a child's health that may have some side effects we need to weigh. It isn't a product that serves a safety purpose and only 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. By talking about the so-called safety benefits of bumper pads both the manufacturers and the CPSC staff are saying a crib is not safe on its own. That's a very dangerous message. Bumpers don't make today's very safe cribs any safer they just increase the likelihood of suffocation or entrapment. When Dr. Thatch published his research in 2007 in the Journal of Pediatrics we thought that that would put an end to the sale of crib bumper pads. Dr. Thatch you'll hear from today with more recent research found 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 the bumper pad. But unfortunately the industry tried to discredit the research and bumpers remained on store shelves. In February 2010 Aidan suffocated against his crib bumper in Texas. His grandmother had purchased the bumper pads herself led to believe they were important to keep her grandson from injuring him or himself. Imagine her heartache after learning that the very thing she purchased thinking it would protect her beloved grandson ended up being what suffocated him as he slept. Then we met Preston's family. 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 ended up with his face between the bumper pad and the mattress. Immediately after Preston's death the CPSC along with the 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. We're now beginning to see them creep back in online and urge CPSC to stay vigilant on this issue as well. But no action was taken by CPSC to eliminate the bumper Preston suffocated against. As we've seen with both bumpers and inclined sleep products more recently almost safe is not safe enough. Manufacturers say bumpers keep a baby's arms and legs from getting stuck between the slats. But our recent review of saferproducts.gov this month showed that on that database where an age is reported 95% of the reports of limb entrapment in cribs are babies over the age of six months when manufacturers themselves recommend the product be removed to prevent falls. So the message is if parents don't heed their warnings the product offers protection. We must stop the use of crib bumper pads for our vulnerable babies. A bumper bruised the leg or even the head is nothing compared to the horror that Preston and Aiden's families and others like them face when they find a lifeless baby. The CPSC proposed rule is based on limited data as others will show not only does CPSC not have all the cases seen in other research they in many cases have ignored the medical examiner's finding and substituted staffs. This proposed rule is based solely on their own research with no consideration of additional research much presented here today that shows the danger bumper pads pose. The only completely new test in this proposed rule addresses only one scenario the mechanical suffocation where a child's nose and mouth are completely closed off by an outside product. A standard based on this proposed rule would simply mean that the very type of bumpers we know have suffocated children would now be labeled by the CPSC safe creating even more confusion among consumers. CPSC's report table one in the report with the proposed rule shows 53% of infant deaths involving bumpers were caused by entrapment or wedging a hazard that will not be addressed by the rigid bumper that the standard proposes and it may increase the likelihood of entrapment between the bumper and crib side mattress or other object. An additional 8% are categorized as possible wedging or entrapment. The incidents that don't result in death are as important to look at as the deaths. We see additional near strangulations entrapments and babies found under or behind bumpers that could have led to serious injury or death. Interestingly the largest number of reports in this category of non fatalities is slat entrapment. The only safety reason given by manufacturers to have a bumper it appears that perhaps bumpers are not effective even in preventing limb entrapments. In addition the firmness test is using a test that was developed for testing sleeping surfaces not vertical padding around the infant. There's no evidence that this test would eliminate the hazard and might even cause additional hazards when the now rigid mattress like bumper is upright in place. And there is no evidence given by the agency to show that padded bumpers of this thickness have not been involved in incidents. It will encourage thick more rigid bumpers which again has not been shown to reduce the risk that bumpers pose. The proposed rule points to the state and local laws and crib bumpers that could be nullified if the standard is adopted. In addition to the two states and two municipalities listed New York has recently adopted a ban on padded crib bumper pads. If this rule is adopted and preempts these local laws more than 400,000 babies annually will lose the protection that they now have from this dangerous product. And no babies will be any safer since the rule still allows dangerous padded bumper pads. In addition the risk of suffocation from crib bumper pads there's also the issue of contributing to sudden unexpected infant death by reducing airflow in the crib and confusing parents on the safe sleep message. The messaging is simple and straightforward. Back to sleep, bear is best. Both messages have reduced infant death. But bear is best runs counter to our intuition of what we think babies need. Softness and padding are the opposite of how babies sleep safely. Which is why the sale of padded bumpers not only increases the risk of babies suffocating on the pad itself but of following the lead of manufacturers by adding more padding around their baby. Those in the child safety and public health arenas work tirelessly to educate parents on this concept. Bumpers make it all the harder. As long as bumpers are still on store shelves and internet marketplace they will continue to be used and babies will continue to die despite every health and safety organization warning against their use. As has been repeatedly said parents believe it would not be sold if someone had not made sure it was safe. And it's important to remember as you see here today that every health and safety organization that deals with infant safety oppose the sale and use of crib bumper pads. I urge you to move to protect our most vulnerable consumers from this unnecessary product and ban crib bumper pads. As I said we thought in 2007 we had enough data to compel us to stop selling this product. I was wrong then but I hope you take the action now 13 years later. Thank you all very much for your testimony. We'll now have a round of questions and I will begin with my questions. So Dr. Sharfstein you made this point and others have echoed it but I'd really like to nail it down if I could and that is the assertion that there's no benefit associated with crib bumpers and we've heard of two at least and one of which is comfort and the other of which is the prevention of limb entrapment. So may ask that you elaborate on your point that this presents or gives us no benefit and others after Dr. Sharfstein answers if you want to weigh in please do. Sure I mean well when I say no benefit I mean no meaningful benefit. Nothing that should be relevant to counter the risks that are there. But really I don't see you know what even if you were to look at like what is benefit look the evidence that we have of harm are not just medical examiners but even if you take the CPSC's conclusion the kids have died from crib bumpers you know in in I think 83 of the cases it's not incidental. That is meaningful evidence of harm. So where is the evidence of a benefit that can't where's the rate of limb entrapment where's the consequences of limb entrapment. I was looking for that section in the proposed rule like that's how I would think about it you know. I mean are we talking about 100,000 limb entrapments versus one that like how do you even begin to do that. There's nothing no organized analysis on the other side. There's sort of like you know the theory and then what evidence is there as the people here on the on the panel have said is really related to older kids and I think Nancy Calzman a good point that it's there with the crib bumpers too. They're kids who are entrapped in fact it might be easier for all we know to get entrapped with that because once you get your arm through you can't get it out because you've got the bumper preventing you from doing it you know. So I don't know if that's true. I don't know very much of anything but like after all these years there's no compelling description of benefit that can counteract what is in fact a very compelling you know description of harm that the CPSC accepts. So I would invite comments from any of the other testifiers in particular the existence or lack of existence of any data sources or any peer reviewed studies so I think Dr. Moon I think you mentioned that in your testimony. There has been one study I believe that by yet at all that looked at the risks or the benefits of of crib bumpers and and found that it didn't really they they did not reduce the risk of limb entrapment and limb entrapment as as Dr. Hoffman said is a nuisance but it doesn't generally cause injury and I think that the reason why there haven't been many studies on this is because there really is not much injury that occurs as a result of this. So you know for a child to have a fracture or something like that due to limb entrapment it generally doesn't happen unless the child is old enough that they shouldn't be using bumper pads anyway and yet concluded that that the benefits did not outweigh the risks of using bumper pads and so they concluded that bumper pads should be banned as well. I appreciate that comment one of the other things that I found intriguing and troubling as I was reviewing the staff briefing package and as I've looked at your testimony is what I would call the confound of soft bedding because a fair number of these incidents seem to involve both soft bedding and crib bumpers and trying to sort out what the risk is is a difficult challenge and I'm curious if any of you have any insight looking at the data that we have and looking at the data that you've cited about how we tease that out and what meaningful causal nexus is there between the crib bumper and the fatality of a child. Dr. Hoffman if you want to start. So I'm not aware of any data that specifically looks at that but I think we need to look at this from a harm reduction standpoint and that you know go back to what everybody in the panel has said we know what a safe sleep environment looks like. It's difficult because products are there and there is pervasive attitude about what you know how parents want their babies to sleep. The fact that things that there is an opportunity for them to utilize something like a crib bumper if you know as I said in my experience with the sales person it's there. We don't know I can't tell you 100% that in circumstances where there's soft bedding in the case that Ms. Cowles talked about with an infant who is on a position or who rolled over. I'm relatively certain although I don't have data to back this up that if the crib bumper wasn't there and the baby had rolled off they were much less likely to suffocate. I think we need to think about this from a harm reduction standpoint and soft bedding that's a fight we're going to have to continue to fight. We can't ban blankets across the board but a product that's specifically manufactured and marketed for infants that we know to be dangerous is not something we should have. Dr. Sharfstein? Yeah I was going to say like there are deaths where the child is found press suffocated against the crib bumper. I mean there's no question in the mind of a very experienced medical examiner like we had in Maryland that it was the cause of the death. I find a lot of this kind of picking through and this happened in Maryland too like how many of these deaths really you know how many does it take? You know the CPSC found 83 non-incidental deaths. Now maybe the number is 500 maybe it's 400 maybe it's 100 it doesn't matter to me and I don't think it should matter to you as you're thinking of the whether a risk is unreasonable it's unreasonable to have a risk of death for a product that has no meaningful benefit. Ms. Cowles one of the things that you mentioned and others did as well is the notion of the CPSC not taking stronger action against crib bumpers somehow sending a message that they're legal they're safe and I don't think we ever take the position of endorsing the safety of a product but by virtue of not banning it we are in effect saying it does not present an unreasonable risk of injury and that is a proposition that's an implicit endorsement of crib bumpers and I was wondering if you have any further elaboration of the point that you were making in that regard and again I invite anybody to join in as well on that point. Yeah I think that as we've all talked about and all of us here work daily to try and get kids in safe sleep environments we talk about the soft bedding. It is complicated when manufacturers are selling soft bedding again by the fact that it's still in stores because you haven't eliminated it as a product it's going to be assumed to safe we can all say anything even CPSC says bear is best occasionally right and so but that doesn't resonate if they go to the store and find it because if you really thought it was unsafe it would no longer be in that store is what parents think and I think the important thing is it's a hard message to get across a bear is best right it's the opposite of our intuition when it comes to babies and that's why we work so hard on the messaging and selling soft bedding because you differentiate between soft bedding and bumpers they're all one in the same a bumper is soft bedding it's something soft you put into a child's crib and so as long as you're selling one thing that you say is safe then you're confusing those parents because what's the different from them putting a rolled up towel you may see the difference but they wouldn't see the difference because you're already selling them something that seems similar to them so it's a hard message bumpers make it harder one of the things that you all mentioned is that at some point and presumably six months is when a child can step on the crib bumper and use that to get out of the crib and that presents a brisket in and of itself and as I understand it manufacturers warn against that and our proposed standard has this warning that dr. Sharfstein mentioned and I did want to mention a concern I had because it isn't until you get the very bottom of that and not in bolded it says remove this product when baby can pull to a stand using cribside print starting about six months older babies can use the product to climb out of the crib and I'm curious if you have a reaction first of all to the specifics of this warning but secondly to the aspect of warnings in general how likely is it if a parent seen that warning for six months that they would stop noticing it or would not react to it dr. moon if you had a comment so first of all in the fewer than half of the parents who would read the crib warning they would most likely read it when they first bought the crib having been a parent I often didn't remember the next day what I had read the day before as opposed to six month down the line where you say oh yes today is Johnny six month birthday it is time to take the crib bumper out of the crib because that's what I read six months ago so I don't think that that's going to happen so I don't so number one I don't think that the crib warning the crib bumper warning is is effective nor do I think that it helps to protect the children and I'd also like to mention a little bit about selling products please do it in 15 seconds if you can in six 15 seconds we have to also deal with what the social norm is and if if everybody believes that you have to be a good parent in order to be a good parent you should buy these things because if you don't then other people are going to judge you then which is what this this person at the store was trying to do to dr. Hoffman then then you're going to buy the product so we need to we need to send the message that this is not normative behavior thank you all very much I now turn for questions from commissioner k I hope you're still there and please feel free to ask questions at this point I am and thank you mr. chairman I want to assure you in your itchy gavel hands that I am running a 10 minute timer here thank you I want to I want to start with dr. Scharstein and actually first say to all of you how much we appreciate your expertise and also taking the time to come in because obviously there are costs in terms of people that you're not seeing patients you're not seeing for some of you are advocacy that you're not doing in other areas and so it means a lot for us that you would come in and I would say that's all the panelists that we see as well later today I'm sure that when you saw that the hearing was put on part of the reaction for all of you was you got to be kidding me what is taking this agency so long and isn't it so obvious to everybody that a conclusive case has been made that these products need to be addressed and I can't speak for my fellow commissioners but I can say that at least in the time that I've been at the commission I've been convinced for a long time that the case has been made and so I think it's important to try to focus a little bit on why has the agency not done more and I would assign most of that blame really to the statutory structures that we operate under and and dr. Scharstein I completely hear you when you talk about the framework that you used in Maryland and that you would continue to use in how you would assess the hazards unfortunately we have a more rigorous not rigorous in terms of from a public health standpoint but really legally a more rigorous legal standard that we have to follow and our two choices are either either to follow section seven eight and nine of the consumer product safety act and to seek a ban or if we believe it's a durable inter product which I do and the commission I believe is already says it does to try to come up with an effective regulation under section 104 if the goal of the stakeholder community is to have regulatory action done by the agency I do think it's important that folks focus in on the legal requirements that exist in those statues particularly if you seek a ban section seven eight and nine of the CPSA and use the remainder remaining comment period time to provide the kind of data that you believe exists out there that would support the various factors in that statute in the absence of having that data and even sometimes with that data it's still a challenge for us but certainly in the absence of it we have no chance of moving forward in a regulatory fashion and we can completely agree with everything you're saying I personally do agree with everything you're saying but that agreement alone does not help us in terms of satisfying those statutory elements it just comes down to whether or not we can make the case and so again I urge both the panelists here at any panelist and any stakeholders on any side of the issue to look at the statutes and look at what is required and if you feel a case should be made to go ahead and to provide more data along those lines so having said that I do want to turn to some specific issues and first Dr. Sharfstein I do want to assure you that I would not support any efforts by the agency that would preempt stronger actions taken by other jurisdictions I do not think that that's the way it should work I don't think that consumers are well served by that and again I can't speak for my colleagues but I want to make that assurance to you beyond that though part of the frustration is that we are dealing with a discrete product category in a larger area of unsafe sleep and I hope that all the panelists would be able to continue to help us if we are able to address bumpers how we move past to address the remaining issues of safe sleep and so without getting into too much detail I'll start with Dr. Sharfstein but I'd like to hear from all the panelists do you feel like if the agency is able to deal with bumpers you have other specific suggestions that would help us tackle infant safe sleep issues on a larger level you know I think I'm going to defer to my colleagues here who work more intensely on safe sleep I'm here as sort of like a little bit of based on my major focus on bumpers and I would look to the experts in the AP I would just say two quick things one is to your point I don't know of any other issue where you have the entire scientific and public health community aligned on what the evidence suggests the public agency could do if I were back at FDA I would be so happy for an issue where everyone who was interest was in the health of children that was their job actually agreed with what should be done that is so rare it is extraordinary that in the face of that the agency hasn't yet moved forward second just if you permit me very quick point and I very much respect your position and I'm as I said I'm not a lawyer I think the view that that we have and that the Attorney General in Maryland has is that there is adequate authority to ban but if in the end you decide there isn't it in my view is the responsibility of the commission to state that you believe the product should be banned and you don't have the authority and to ask Congress for legislation to do that I think that is the responsible regulators position if you think that something is the right thing to do and so that I would not just stop by you know but by saying that in a hearing I would recommend that the commission flatly say that this these products are unsafe they should be banned we don't think the legal standard is met help us with a different legal standard I think that's the responsibility I'm not saying you need to conclude that but if you do conclude that that's more important than setting a standard that actually won't protect kids and if I before Dr. Moon jumps in if I can just respond to that and I do appreciate that suggestion then I recognize it might be splitting hairs but we sort of did do that in 2016 when four of the five then sitting commissioners came together and said we based on the data in front of us we do not and while we continue to work on regulating these or or otherwise we do not believe that they should be sold and we do not believe that they should be used I recognize that's not speaking directly to Congress but certainly Congress can infer from that statement that based on what we knew at the time we had reached that position do you feel that that that was not a direct enough statement to Congress trying to think what I was doing in 2016 I did not penetrate my world believe it or not I was not aware I'm glad that you did that I think that I would recommend doing it again and more clearly if that is that in fact is your conclusion great thank you Dr. Moon I would agree with everything that Dr. Sharfstein has said with regards to your question about are there other soft bedding products or products that I would recommend banning if we once if we finish with bumper bumpers and I'm not clear that we will but that's hard to say because one could spend one's whole life chasing products on the internet every week I get a an email or a phone call from somebody who is concerned about a product that a parent is using and I look at it and I was like wow I didn't know that existed and it's hard for me to to be able to say and maybe Dr. Hoffman had or Nancy Coles has has more insight into this to say there are specific categories of products that we would go after next and I for me I don't know that that's the case but I do know that it's it's wild wild west out there and it just seems like every day there's another product on the market that I look at and I think oh my goodness there are so many hazards here yes we feel the exact same way Dr. Hoffman I'm going to go ahead Commissioner K if that's okay it's Nancy obviously sure given the limited time here I think the CPSC has already started work on the next most important thing with safe sleep and that's the infant sleep product standard that would eliminate these daily entries into the market of products that consumers assume you have to already decide they're safe but have no standard that covers them there should not be a product available for sale for an infant sleep environment that doesn't meet a federal standard it's the one place we leave children alone babies alone it's the one place where it has to be completely safe because not only do you put your baby in there to sleep but it's the only place a very exhaustive caregiver has to put the baby down and know that they might not be happy but they will be safe and the fact that we allow these we saw what happened with the inclined sleep products there's more products like that so I think that's the next important thing for this agency to do great thank you and in 15 seconds dr hoplin so thank you commissioner k I really don't have anything to add on top of that other than then echoing what miss callus just said about addressing standards I think you know I as a pediatrician I acknowledge that for many families or most families sleep for infants is among the most complicated difficult things they're ever going to do and the promise of hope I think is what pulls people forward and selling hope in a way that's dangerous to babies is something we just can't accept thank you thank you so much commissioner bioco thank you thank you all I found all of the information extremely interesting I did read everything with one exception which I'll get to and I do understand it all including the physics dr hoplin um dr um sharpstein I I think the most compelling thing I've heard so far today is what you said about the weighing the risks and the benefits I think that that is a very compelling point what I do not agree with you on and I don't think you're right on is the legal analysis for all the reasons that commissioner k said and more we do have an absence right now of data to fall into the the two categories so on that note do you have it's been a while since Maryland banned the um crib bumpers do you have any data that demonstrates that the reduction in infant fatalities in Maryland is directly related to the ban that would be helpful if you do it's too complicated to be able to say it's directly related to the ban but we do see reductions in sleep related deaths considerably steep reductions in sleep related deaths and so that um we think is both direct and indirect you know both because of you know the potential that maybe there would have been actual kids smushed up against the bumpers but also because um particularly Baltimore City where we've gone from 25 to 30 uh sleep related deaths a year down to seven to 12 depending on the year um there's such a strong clear safe sleep messaging that is very clear no bumpers know anything and so I think it's helped with that messaging so it's I mean I think our view is it has been helpful but um it's not possible to assign a specific causality um thank you um I'm going to jump around here I'm sorry um if I'm jumping around Dr. Hopman when you went into the retailer and asked about that um I'm not sure I followed everything you said so you went in and your your assistance not really pregnant right you just okay is that your only experience with the salesperson oh goodness no okay so do you have I'd be interested in um whether there's a study as to you know is is there anything consistent that we're hearing out in the market or do you know of any study like that I'm not aware of any studies like that um my children will tell you anecdotally that I have been doing that for years um and it has been a very consistent experience I do that with with car safety seats as well interesting at retailers just because I'm very passionate about this and I'm interested in what my what my families are hearing um and a lot of that is driven by my experience as a clinician when when parents and caregivers tell me of an experience that they had um and I have had experience I have had um um direct experience in um co-workers um in putting together um lists for baby showers um asking about things actually one of my co-workers um currently who has a two-year-old um when I emailed uh my staff to say I was coming here said thank god you're going I still I have so many friends who are still using those and they won't listen to me so I don't have any hard data I think that would be a great thing for us to do because what bought what what something you said I hadn't thought of before and that was your point about blankets if they're misused or we do have data of children dying because you know they suffocate in a blanket or too much stuff in a crib whether it's a crib bumper uh blank extra blankets pillows and Miss Coles I think you also mentioned the rolled up towel we used to have the positioners and my kid was born there were positioners and and so forth um are you can I mean you're not saying to a band to ban those products as well as well I think what I'm hearing you say is we need to get that there is best messaging out there and no matter what you tell parents they are going to do what they think is best correct yes but I think that there are issues there's a there's a difference to me between a blanket which I would not recommend for a you know a younger child and blankets are going to be sold outside of specific you know baby baby distributors and baby stores but there's something about bumpers specifically manufactured and marketed for for a purpose for an age group and again as was repeated by multiple members of this panel have no demonstrable benefit and clear associated risk and I think we need to take the harm reduction approach and say if that's one thing we can do we should start with that which which I hear and I do get what I what I'm concerned about is we do have a a structure a rigorous legal structure we are working involved within and as Dr. Moon pointed out and I think is also a good point when you're buying stuff online or you get online you're going to get stuff coming in and if there's if the products don't have a standard or some standard that we can come to the middle and agree we're going to have an even bigger problem because there's everything you could possibly imagine out there especially from organizations outside and who aren't following the standard go ahead could I respond sure so there's a a past history of when the FDA was investigating taking infant cold medicines off the market and we had a hearing at FDA I was a health commissioner in Baltimore we had let a petition to take them off the market similar argument no evidence of benefit deaths of infants and the major argument I would characterize as like let's protect the parents from hurting the babies that was the response by the companies that made that they said if they don't have these generally ineffective but rarely harmful medicines to give they'll do all kinds of things and people were testifying they'll give the adult dose to kids they'll I mean and they do all those things are possible right there's data about what happened after that came off the market they're multiple public studies dramatic reductions and overdoses dramatic reduction of injuries in the case of the over-the-counter cough and cold medicine I don't think it's true I don't think the parents want to hurt their babies I think the parents listen to clear messages that come from their doctors from public health agencies and ultimately from the CPSC don't use it because it's unsafe people listen to that and I think that the answer we were warned we were going to make things worse for kids study after study showed dramatic declines and harms to kids when we did that and I think the same exact logic with the same exact parents and the same exact age group would apply here and the same exact data if you have would be very helpful if there's a direct correlation to the Maryland ban and the reduction in child sleep deaths it's it's very important and I can't stress this enough that the legal structure that we're working in as Commissioner Kay pointed out is is binding so what but can the legal structure really require that a state yes it does yes it does okay Ms. Coles here's my one exception that I didn't read I did not get a chance to read what you submitted either last night or this morning I didn't get it till this morning what's different between what I had yesterday and what you submitted today so today I added and you probably heard a little bit more on the rule itself okay but but the basic arguments and everything was my main points were in what was submitted earlier okay and I went back and looked I didn't remember hearing this or seeing this when I read it so I may have missed it or it's in your new version but you you you said that the there were instances where the our CPSC staff substituted its view for the medical examiner you see something like that so I think you'll hear that in later testimony today that there are cases where on the death certificate it is said that the baby suffocate done the bumper and the staff in reviewing it decided that was not the cause okay I would really like to see those those incidents if you don't hear that this afternoon in the testimony I will get the information to you okay all right thank you very much it's very interesting very helpful appreciate it thank you Commissioner Feldman thank you and I want to start by thanking all of you for being here today I wasn't here in 2016 when when we last took this issue up in a meaningful way therefore I'm new to the issue and very much in in listen and learning mode today so hearing all of you talk about the research that you've done is incredibly helpful I think what makes this this this issue difficult in addition to some of the issues that were raised today is that you all have had an opportunity to take a look at at the underlying data and come to a conclusion on the other hand some really smart people including researchers on our own on our own staff at the agency have looked at the same data and come with different conclusions so we're in the process of sorting through all that but Dr. Sharfstein I wanted to start with you and drill down a little bit more about what the experience has been in in in Maryland it's useful to have a state that has has gone and put through a product ban in in place and being able to take a look at sort of what that experience has been should be instructive for um for for us as as we grapple with with a very very similar issue although as I think is is being teased out in the conversation here it sounds like there's different standards that may be at play so when you were addressing this in Maryland what is the Maryland standard for products a product ban actually the Maryland standard is based on the cpsc standard and I I'll get you the exact wording we have a state um law that I think and just because I'm not 100 sure remembering this I'll go back um is is based on a cpsc law and we use that law and then we did a regulatory process pursuant to that law okay to you know get as much information as we can convene external experts do a whole two public common periods everything we could to figure out whether these were unreasonable risks okay because our standard to ban a product under section eight of our statute is more than just whether or not the product represents an unreasonable risk um there's a whole second part of the analysis that takes a look at whether there's any feasible product safety standard that would have an adequate reduction in in in what that risk is and listening to the discussion here today diving very deep into this question of um whether a benefit exists and I'm hearing some shades of a variation in how you all are answering that question I'm hearing that there's no benefit to the to the product that there's a minor to negligible benefit that there's some attendant safety benefit with some of the breathable liners but but taking that all aside I think that that um risk to harm analysis really speaks to the first part of the question that we need to answer with respect to whether or not the product represents a an unreasonable product hazard I mean I don't read anything in the documents that there's a way to substantially lower this risk sort of taking them off the market anywhere any of the any of the research to suggest that and I don't actually think there's that much of a scientific dispute and maybe this is where I'm a little bit I know that people are going to be arguing this death is it this way or that way right but the cpsc staff believes these things contribute to the death of children I mean it is incontrovertible when you look at some of these deaths there is a death risk against that I think we're all in agreement no meaningful benefit you know and so to us you put those together you have no evidence of doing anything that will actually reduce and that risk of death to an acceptable level which I don't know if there is an acceptable level of risk of death for a young child um then we believe that the legal standard can be met and you know I realize that it is and that that everybody here is is doing their best to understand what what the legal framework is I think um I read this uh you know in pediatrics sometimes we think are we treating ourselves are we treating the child are we doing something to make ourselves feel better like putting a confusing warning label on is not helping the parents you know it's just not it's treating ourselves in a way we sort of feel like maybe there's some standard we're meeting what would treat the child what would help the child is unquestionable and even in all the questions today if everybody is in agreement that they're the harms outweigh the benefits of these products then you know and there's no way to eliminate them that is an unreasonable risk of injury sure but I don't I don't want to belabor the point but whether or not there's an unreasonable risk of injury is just one part of the many questions that we need to get to in order to accomplish what you are all asking us to do today which is to ban the product under Section 8 of our statute um you know the the the question of labeling you know whether or not that label is is confusing um you're actually in some ways arguing against what you're asking for because if there's a way to make those labels less confusing then there's perhaps a feasible labeling standard that could be applied that that makes it just more difficult to get to the the the outcome that that I hear you all asking us for and you know please hear that that that I'm struggling with this because you talked about acceptable number of deaths there's no acceptable number of deaths any of these deaths is is tragic um but as Commissioner Kay said uh and and and what what I hope you're hearing there's bipartisan concern on on on the on the on the commission um that we're not there yet with respect to meeting all of the requirements that that that we would need to get to to have a ban that that that is enforceable and and and that won't fall when it's challenged so I really do want to get this right I totally appreciate that and I um my point about the labeling was not that I think there's a way to make it less confusing but that I'm trying to understand a little bit of how the CPSC staff is thinking about this yes and I just think it's completely in the wrong direction I mean yes less than half the parents say they read all the labeling and that's even at birth and there's I don't know whether um labeling can reduce the risk unless people don't use the product at all and that's that's a discussion but I think that's part of the discussion that we need to have in order to get to yes on what I'm being asked here today to consider and and what I'm hearing from from the panel today is an extensive conversation uh and and deep dive into whether or not the products are unreasonably unsafe but but again what I'd like to hear more from is a a fulsome discussion of of all of the requirements that we would need to make and and go through any you know feasible safety standards that that may be applied we need to be able to dismiss those arguments as well in order to do what you're asking us to I mean I don't think any of us believe there is a feasible safety standard okay but again I'm not hearing that argument being made I personally see bumper bumper pads as being like smoking as cigarettes there is no reasonable benefit to smoking that outweighs the risk of smoking and this is for a particular population um and and and I think that one of the issues is that um I talked about social norms before people believe what the salesman is going to tell them okay people believe that there is that somebody has tested these and has made sure that they are safe for their baby nobody has done that nobody has done that and by by by selling these we are telling parents that this is safe and parents believe that they are going to be judged because they don't buy these because the salesperson is judging them because oh you're not going to buy that but it could make your baby safer and the last thing that a parent who doesn't know anything about parenting once is to be judged they don't want their they they don't want to be judged they want their child to be safe and they want their child to be happy those are the three things that they want and we're not helping them with any of these things we're not making their child uh safe we're not making their child happy and we're you know and by giving by selling these things and then giving them a message that they're okay we're giving parents a sense that they're being judged if they don't buy them I hear what you're saying and and I think too if I if I'm a commission fulfillment that having them on the market completely negates our counseling when I meet with a family um you know to me my the beauty of being a clinician is developing relationships over time and trust um and for me to be able to sit in a room and say all right here's here's what we know about safety appears the safest thing you could possibly do and then to have them go and be bombarded and it is it is social media it's it's the internet and it's retailers anything that that that casts doubt or makes it easy for them to do something else they will do I've seen that repeatedly in the in the car seat space um and you know the more I've gotten engaged in safe sleep the more I'm seeing it here as well that we need it needs to be consistent and having products on the market that that countermand what we know to be safe makes it fundamentally difficult and dangerous for babies and we need to think about it from their perspective yes but the standard for which we can ban a product isn't whether or not the existence of that product on the market is consistent with what the American Academy of Pediatrics is is messaging is it at any given moment right it's it's a more involved process in order to to proceed in a way under our statute with a band that's going to be upheld we need more than that your time is expired uh and um if I if I could uh you're you're you're front over but if you want to make a final point by all means do that uh I was just going to allow Nancy to to contribute and I appreciate the consideration I would just say that we are all working to get you what you need to do a ban we're also working with congress to do a ban that way but cpsc in the past has banned a product with a standard that's infant bath seats so instead of your staff coming up with reasons why these products should stay on the market they could put that energy into writing a standard that would ban bumpers as we know them require the same airflow as no bumper with any bumper that's in there that's going to be impossible to meet require different things you have done it before you can do it if that's the way you want to go but we are also trying to work on these other avenues my time's expired and so we're I want to thank the first panel for your excellent testimony we will begin the second panel at 11 25 but I did uh add want to add one thing and uh Ms. Coles you're a pretty good lawyer for not being a lawyer uh there there is no requirement that we address crib bumpers under section eight it's certainly one uh possibility but the discussion that we've been having is addressing them under section 104 where the test is dramatically different this is the point we can debate at some length but again I do want to thank the panelists for your excellent testimony and we will begin a testimony at 11 25 or so we're going to take a quick break welcome back I see something that must be a set of slides that we were going to see on the screen up there we welcome our second panel and we're going to go from my left to my right and so Ms. Jacobson if you want to proceed thank you for the opportunity to be here today my name is Allison Jacobson and I am the CEO of First Candle we are the national non-profit committed to ending sudden unexpected infant deaths especially SIDS and accidental suffocation and strangulation in bed I am also a SIDS mom my son Connor died in 1997 and while I say I'm a SIDS mom that might not actually be the case at that time I didn't know about the dangers of blankets and crib bumpers and like so many other moms at that time my son's Connor's crib was adorned with all of those things at First Candle we also have a 24-hour grief line and online support groups and every day I unfortunately have to welcome new members into a club none of us want to belong to they share their stories and their pain can be felt in every word and unquestionably the majority of their stories have a similar theme their baby was in bed sharing or was in his or her crib with a blanket or had crib bumpers in their crib and not only is their grief palpable but so is their guilt they feel like they killed their baby I had one mom ask me directly if she was going to hell and sadly they learned too late that bed sharing or having blankets or crib bumpers can cause their baby to suffocate perhaps the most heartbreaking comment is no one ever told me and the most infuriating question is if crib bumpers can cause my baby to suffocate why are they sold and this goes back to what we heard from the other panelists they assume that if it's on the market it's safe and maybe that's not the case but as a consumer that's what we're led to believe we also see as one of the panelists said things from pottery bar and cribs and all these beautiful layouts and crib bumpers and we assume that's the norm every year 3,600 babies die from sudden unexpected infant death and currently 26 or percent are caused by accidental suffocation or strangulation in bed and another 36 percent are undetermined which means they could have possibly been caused by suffocation or strangulation over the past decade we have seen 110 percent increase in accidental suffocation and strangulation in bed these are deaths that can be prevented there is no need for crib bumpers and we have the ability to at least eliminate one risk and that's why first candle strongly urges the CPSC to ban these crib bumpers thank you thank you very much miss lesh good morning and thank you for the opportunity to testify today i'm jen lesh the ceo of breathable baby a mesh liner manufacturer from minnesota actually chemists turned ceo i bring that up because you'll find a lot of data research and that i'm a fan of products based on science that's why i'm very proud to lead breathable baby let's take a step back to our origin it goes back to 1999 when dale and susan waters woke to a piercing cry and found their three-month-old seara with her leg wedged between the slats and her face pinned against the mattress based on advice from their pediatrician they had no bumper she was very active continued getting stuck and after many sleepless nights they became desperate and without a safe solution on the market they took matters into their own hands to find a thin breathable material the idea for a mesh liner was born and we were founded in 2002 today i plan to establish three things first mesh liners are substantially different than padded crib bumpers both in construction and performance second mesh liners are safe there is no evidence to the contrary and third moms and dads who want an entrapment solution i will end with a request that regardless of the standards you choose our mesh liners be allowed to pass and continue providing a safe and reliable alternative to bumpers let's review the differences many spend time talking about the dangers of bumpers but spend less time on the reasons why the material and the construction specifically two layers of fabric with inner fill it's obvious fill is thick but what's not obvious until under a microscope is it's not uniform that means poor airflow out and the risk of rebreathing co2 in when fill is covered with fabrics it can further restrict the air flow because the fill's openings misaligned with the fabric's openings let's look at the samples i've provided the pink bumper has zero permeability in cubic feet per minute or cfm as measured by astmd 737 the fill alone is 32 the fabrics both the zero not safe on the other hand the gray bumper the outcome is the same zero cfm the fill in this case is 420 cfm but the fabrics measure three and four the result is lower than the parts and still unsafe different bumpers same unsafe results and demonstrative of the reason the water scoured the world to find the right fabric and we've invested countless hours and dollars into research to refine our breathable mesh mesh is a single layer created by a process called warp knitting and commonly called a spacer fabric unlike the problems with fill the 3d structure of mesh is open uniform and made entirely of interwoven strands of thin yarn our mesh has visible holes ranging from one to five millimeters wide and the spacers make our mesh less than five millimeters thick to avoid presenting occlusion risk that's one fifth of an inch versus a bumper that's up to two inches per allowable standards mesh liners are made from sorry about that mesh liners are made from a completely different material and are engineered to be thin and highly breathable a study by virot veritas in 2016 on the left tested four of our liners against 10 commonly available bumpers our classic mesh we still use in production today measured 1031 cfm nearly 25 times more permeable than the bumpers tested which range from 21 to 70 the npr references a report that used test method bs 45 78 for infant pillows the cpsc determined the testing was not useful in suffocation for bumpers and we have no reason to disagree however the test did show that the pressure changes associated with mesh liners were undetectable at average infant airflow breathing rates of two liters per minute the results on the right show a distinguishing line at 0.003 inches on the chart that separated liners from bumpers both bs 45 78 and d 737 show a clear demarcation between liners and bumpers we commissioned an environmental health expert to compare bs 45 78 results to d 737 results and our specifications he applied Darcy's law which evaluates pressure drop and flow rate as a function of permeability and this theory reaffirmed that an infant would not experience resistance through our liners in fact he noted our minimum specification of 700 is more than 15 times that distinguishing line noted in the report that brings me to my second point the safety of our mesh liners we have sold over four and a half million mesh liners without a recall and without a single report of injury death or emergency medical attention if each of these four and a half children slept in their crib overnight and took one daily nap for three months that's over 800 million data points whether it's four and a half or 800 the incident rate is zero we were very surprised to see in the npr that it cited 15 non-fatal incidents that contain the word breathable or mesh the details were not included so we foiled them and confirmed that none of them none of the 15 presented suffocation hazards related to mesh liners three incidents were complaints unique to padded bumpers marketed as breathable fuzz in an infant's mouth wood sliver in the padding and a bumper that wasn't thick enough eight involved children getting their limbs entrapped in slats despite using a mesh liner to involve red marks from contacting or rubbing on the liner one was an odor complaint and one mentioned mesh in play yards and was unrelated to mesh liners moving on to my third point we support bear is best but not everyone will go bear caregivers want a solution a 2015 consumer study showed 74 percent of moms with infants ranging from six to 12 months used a bumper liner with one of the top reasons being to prevent entrapment a 2019 study led by nj shears with moms of children under 24 months showed 90 percent of moms used a bumper liner to prevent entrapment higher than our study in part due to age and demographic differences 37 percent of moms in this year's study reported entrapment actual entrapment not all of which ended in the year and she concluded moms with members and liners were significantly like less likely to experience latin trapment a forensic audit of the four cpsc databases by econometrica estimated 280 year related entrapment injuries annually and noted that arm and limb entrapments account for over 50 percent of crib related injuries reported to the cpsc and what about those numerous entrapments that don't end in the ear because parents choose not to go or simply can't afford it entrapment incidents are real data derived from searching over 1400 reviews on just one of our mesh liners shows over 200 reviews with comments related to entrapment and the tangible quality of life benefits provided by our mesh liners in summary crib standards have changed slats are closer but entrapments still occur we need a safe solution for the over 200 or excuse me 2 million slatted cribs sold every year it shouldn't be bare or nothing the risks of it of parent diy and the unintended consequences perhaps of a rolled up blanket are real independent parties have reinforced that the position on the mesh liners they don't pose the same risks as padded crib bumpers a 2016 journal of pediatrics article by nj shears stated mesh liners are breathable and thin and may reduce likely reduce the likelihood of slat entrapment her 2019 study reinforced this econometrica concluded mesh liners appear to provide a potential potential safety benefit in the form of reduced numbers of limb entrapments without posing a potential suffocation risk we respectfully request that regardless of the standard you choose our mesh liners be allowed to continue providing a safe reliable and useful solution to remedy the real world issue of limb entrapments for babies and parents thank you thank you very much miss collier thank you chairman adler and commissioners for the opportunity to share some unique data with you today my name is abby collier and i'm the director of the national center for fatality review and prevention or national center for short we are a HRSA funded resource center and the information that i'm going to share with you are is the perspective of myself and my agency not the federal government our charge at the national center is to support all aspects of fatality review we do this in two key areas the first is programmatic technical assistance sets everything from a site visit to how to conduct a review and the second piece is managing the national fatality review case reporting system or case reporting system for short and that's what i'm going to focus my time on today to tell you about the data that we collect but before i do that i want to explain the breadth of child death review in the united states currently there's child death review in all 50 states plus the district of columbia these teams have one goal they want to make their communities healthy and safe so families and children can thrive unfortunately we do this by looking at how and why kids die as you can see from the slide there's just a great depth of individuals engaged in this work at the community level the state level and the national level child death review happens in sort of three key steps i like to think of it as putting together a puzzle the first thing we do is tell the story each individual child one child at a time team members come prepared with information about the child in the family and they share it everybody in the room shares what they know and we put together the puzzle sometimes the picture makes perfect sense other times we're missing pieces or it's an incomplete view once we've clarified everything we know we collect data and then take action what's unique about child death review is we bring together this diverse group of professionals medical examiners and corners pediatricians law enforcement child welfare local public health and what we get is this multifaceted view of a child in a family but also of our community in order to identify our systems and our gaps our child death review teams are charged with one thing and that's to catalyze prevention if you would have told me more than a decade ago this is where i'd hang my professional hat i probably would have said no but the prevention work is what keeps all of us going i want to transition now to talk about the case reporting system it is a free web based data system used by fatality review teams in 45 states the case reporting system collects a unique set of data as well as the unique depth of data that is available to local and state users in real time so often our teams are waiting for vital records are waiting for other official reports when they're using the case reporting system they can access it in real time which allows them to identify trends in their community and immediately take action as i said it's used in 45 states we have more than 2100 users it's quite a thick book of data questions there's 2600 variables and we have more than 220 000 cases in the case reporting system data in the case reporting system is owned by the state that enters the data but there is a process for researchers to access data to inform their research in fact dr moon has published a number of papers on the data in the case reporting system obviously we think the data in the case reporting system is valuable and unique but i would be remiss if i didn't point out a few of its limitations first and foremost it's not population based data and we cannot calculate rates there are very few states that enter a hundred percent of their cases and so we know we're not talking about an entire population we also know that standards vary significantly across jurisdictions as to depth and quality of dusting investigations what's kept in medical records etc there's missing and incomplete information when you ask folks to answer 2600 variables by the time they get to the end of the form they might be a little fatigued um and that there's been multiple versions of the case reporting system since it launched we're on version five but version the next version is on the horizon i'll transition to talk a little bit now about how we collect information on sleep related deaths as dr moon pointed out in her testimony what is called an asphyxia in one jurisdiction might be called a sids in another jurisdiction and it might be called unknown or undetermined somewhere else in order to address this issue we use a gatekeeper question asking if the death occurred in a sleep environment this allows us to look at these cases regardless of cause and manner of death so what you can see on the screen is where i've highlighted that gatekeeper question we actually ask it for children younger than age five although most sleep related deaths happen to children younger than age one there still is a couple that happen in that older group we then go on to collect additional information about items in the sleep environment so you can see again i've highlighted that we ask questions um about what was in the environment and its relationship to the child so we want to know everything in the environment but more importantly we really want to know its relationship to the airway so we want to know if a blanket was present but we want to know if a blanket was over the face the same is true with bumper payouts to better capture how and why the infant died we've revised these questions and in 2013 this current matrix was adopted and it's still being used today and what it allows us to do is notice something was present if it impacted the airway and if that airway impaction was partial or fully obstructed so we found a total of 84 cases in the case reporting system where the bumper pad was clearly documented to have obstructed the airway there are exponentially more cases that fall in that gray area bumper pad was present but so was a blanket we excluded those cases just for clarity's sake when we looked at those 84 cases we reviewed their narrative and i'll talk more about that in a second and we excluded any narrative that was unclear so we really the data that i'm going to present to you on these 73 cases are really clear cut cases where the bumper pad impacted the death we analyzed the data from 2008 to 2018 from 25 states you can see the demographics up on the slide um of note we found the greatest risk for infants was between two and four months of age which is consistent with testimony you heard this morning from our colleagues at the AAP i also want to point out that we had a higher number of um non-hispanic black and um Hispanic infants in the case reporting system based uh if we compare that to infant deaths as expected about 90 of these deaths occur in the parent's home so kids are at home where they should be it's important to note that 23 percent of infants in this subpopulation were born premature and that um in a typical population we see about 10 percent of infants born premature it's important finding to note we also found that in most of these cases parents were following at least one of the recommendations of the american academy of pediatrics so just to highlight uh dr moons point earlier this morning we see how these deaths are signed out by medical examiners varying greatly um 52 percent are listed as accidents followed by 30 percent undetermined the same can be true for cause of death we see about 50 percent of them listed as an external asphyxia but then we get everything in that category from sids to unknown to an injury so there's kind of great inconsistency and again the use of that gatekeeper question allows us to access this data regardless of how the medical examiner sides it out we also look at how the infant was placed and found we found um by looking at this data that um 31 of the infants were placed on their back to sleep but only seven were found on their back um what does account for that difference certainly some of the infants were developmentally able to roll however we know this is just a small number we recognize that families know the message about babies sleeping on their back and might be giving a biased answer to medical examiners um as we heard earlier we know families want to do the best they can when we looked at the deaths we found that 27 of them had a partially obstructed airway uh 41 had a fully obstructed airway and um in the other cases you'll see an asterix that number was less than six which means we cannot release it um in both of those cases though the bumper pad was listed in the narrative as obstructed but not in the data portion of the form one of the things we commonly hear is that death scene investigations are not collected on these infants however we want to point out in the cases that we're presenting on today there was comprehensive death scene investigation occurring we found that 96 percent or 70 of the 73 had a death scene investigation um same 96 had an autopsy performed and you can see as you read down the list um these cases were well investigated in october of 2013 we added additional questions and in the 20 cases that had those additional case questions 50 had a doll reenactment which is considered a best practice i talked about the importance of a multidisciplinary review and again i want to bring you back to the um quality of information available at the table for these cases these communities were really able to create a comprehensive picture of what happened to these children i want to end by talking about the narrative there's a place in the case reporting system for teams to note a narrative and this is where we clearly see the role of a bumper pad and we found countless examples of a narrative noting um that the infant was found um fully obstructed in a bumper pad as noted in the first one on this slide thank you for the opportunity to share our data with and i look forward to answering your questions thank you very much miss februck right and try to pass the laptop i don't know that it's gonna move you want to trade share we don't start the clock till you're ready okay um hi my name is georgia februck i am the founder of go mama go designs um i'm also one of the co-owners along with five other physicians that own our company um our company was founded in 2005 to create baby products that were safe and innovative to make parenting more simple and more enjoyable uh creating a safe sleep environment was the foundation for many of the products that we came up with and i personally had a negative experience with a traditional grump crib bumper and i knew that there had to be a better solution uh thus our company created a vertical crib liner uh we've sold 1.5 million vertical crib liners in the last 10 years without zero incident rate uh we safely fit on almost any crib a standard crib round crib stoka oval a mini crib uh convertible cribs cribs with headboard sideboards and toddler cribs as well without any need for manipulation to the product itself we are excluded from all city and state vans uh including maryland as well as the recent van in new york uh given our inherent safety and unique design uh we simply remain outside the scope and definition of a traditional crib bumper um contrary to the aap's assumption that crib bumpers are not to be used or are used um after six months is simply not true for our product most parents are purchasing these products at the age of six months for their for their children when the children are becoming increasingly mobile and hurting themselves in the crib uh that's when we see people purchasing our product and they can use our product indefinitely up to two years three years as long as they're in the crib there is no safety a hazard not to use our product we do not provide any instructions or warning labels to remove it at any given time so um that six month limit that applies to traditional crib bumpers absolutely does not apply to vertical crib liners um the the proposed astm standards um they simply just don't even apply to our product because we eliminate almost if not every risk that they pertain to um and the commission's proposed definition of of a crib bumper um our product remains outside that scope as well in the proposed definition um thank you um vertical crib liners are the answer to this problem we are the only safe option we eliminate every fatal mechanism associated with horizontal bumpers explication strangulation suffocation and entrapment uh we cover the full length of the crib rail so we are actually serving a purpose in preventing and mitigating injury as the baby grows and moves uh we're preventing injury to the head the face the body as well um we also close up the gap just a little between the crib rails that we do keep limbs gently inside and when by chance the limb does fall out because we have the liner there it allows them to retrieve it retrieve it more easily uh we also maintain the level of air flow equal to that of of a bare crib we have done co2 dispersion rate assessments by inter tech one of the leading uh toy or child product assessment facilities um and i have provided that uh before in the past and i will provide it again in uh the for the record um so using our vertical liners is synonymous with using nothing on the crib as far as air flow uh we also eliminate the risk of suffocation uh we have a non-continuous convex design where the um the air flow uh is never obstructed among the nostrils in the mouth and that is also in that inter tech study um compared to 100% of continuous surface area that surface area um that a traditional bumper presents uh we provide an optimum consistent amount of high density padding that is three eighths inch thick that's 9.5 millimeters less than a centimeter it eliminates any confusing or senseless arguments about thick or thin um there's no sagging there's no firmness issue um and because we zip on tightly uh there's no uh argument about the length or strength of dangerous ties that's also something that's totally irrelevant to our product most importantly our product is impenetrable the baby can root and scoot and push and crawl and they cannot affect or manipulate or interact with the shape the tightness the adherence um of a vertical crib liner this attribute is life changing no other horizontal bumper whether it's mesh thin thick nor no continuous bumper can offer that guarantee we were also recognized in the Journal of Pediatrics in November 2015 uh Dr. Thatch lauded us as a viable safe option that seems to mitigate some of the problems found with the traditional crib bumpers uh vertical bumpers slightly um will they wrap tightly around the crib rail allowing airflow and reducing the likelihood of flat entrapment and climb outs uh here are a few pictures of our product uh they simply zip on they don't really need a lot of instructions as if a parent knows how to use a zipper then they can pretty much accomplish putting our product on it zips all the way down and the zipper falls the zipper pole falls below the mattress inaccessible to a child and the pole tucks underneath the vertical crib liner itself uh we need to have an option because uh there there are thousands of reported injuries that that take place in the crib they may not need lead to death but they do lead to injury stress pain unhappiness broken bones bruises a child that suffers nightly in a crib is not going to go happily into that environment it also affects the quality of life for families and parents and children when uh the the parents and the children are not sleeping properly on a consistent nightly basis if a child is banging against the crib and hurting themselves uh studies show that babies do want comfort almost over anything else and i as a parent i have a need to comfort and protect my children and i think that's a right that parents have and i think it's a right that we need to consider um when i was preparing for this uh forum i came across an article where a baby who was 11 months old came home from the hospital from houston to san antonio he was born without skin and he was finally coming home do we want to tell those parents that they can't have any thing in their crib to offer comfort and protection to that 11 month old that's been in the hospital for 11 months um also what we haven't talked about at all are special needs families there are over 20 percent of the u.s households that have some have the child with some sort of medical challenge whether that's hemophilia hemophilia cerebral policy down syndrome autism ad we have come across parents that have uh their children have lots of skin disorders that i never even knew about these parents are so grateful for our product we are offering them something that's comforting and safe and protective to these children that are suffering already unnecessarily and staying in their cribs for an extended amount of time these are not babies these are toddlers these are four-year-olds five-year-olds that still need to remain in a crib for their safety shouldn't we offer them something that comforts them we also work with kaiser betten usa they uh create and design uh residential and hospital cribs for special needs kids we have worked with them directly they are fda approved kids their health insurance covers those beds and so does the health insurance cover the bedding as well we also offer vertical crib liners and organic cotton a lot of parents their kids have autism they often choose only organic products and we can offer those to them here are just a few pictures on the right is the kaiser betten and then here is just a regular hospital crib you could see that if you're basically spending half your life in a crib and you're an older four-year-old three-year-old five-year-old that comfort and protection would be welcomed in that environment um i think everyone knows that a recall is long overdue any um the astm stand suggested standards um in the recent proposed ruling um i i think it's baseless um i it's the it's the horizontal nature of a crib bumper the traditional crib bumper or any continuous bumper that is a faulty design whether it's thick or thin the definition of a crib bumper should just follow the lead of the other states and city bans that have occurred and simplify the definition by just saying any continuous bumper uh as part of the uh the ban as you define it uh the jpma's argument that parents will make makeshift bumpers is simply untrue when you have a safe option i'm gonna ask you to wrap it up please okay sure um my main point is that the cpsc needs to create a federal policy um it is chaotic out there for manufacturers and uh we just need a clear concise message and there is lots of evidence to suggest that vertical crib liners are safe there's no lack of evidence out there thank you very much for your testimony thank everybody on the panel i did want to raise one quick comment before i ask questions and i has to go with legal authority and i simply want to state my view as a commissioner uh i have zero interest in drafting a standard either under section seven or section nine of our act or of section eight the consideration that we've been addressing is under section one oh four which i would point out does not require a finding that a product be an unreasonable risk of injury it simply requires that we look to a voluntary standard after consulting with experts in the field and then uh we either incorporate the voluntary standard or make it more stringent and that's the standard that i'm approaching again speaking only as one commissioner i found the testimony today in particular from this panel to be fascinating so miss lesh uh i've read in your testimony and uh that you said there's no quote direct evidence to indicate mesh liners are unsafe and i always get nervous when i see a bit of a qualified statement so can i just say uh are you saying that you know of no incidents or allegations of harm from your product i think you said that but i just want to nail that down yes we have no known incidents related other than the ones that were presented in the npr but those were not a suffocation risk and none of the hazards we're discussing today i'm also intrigued by your statement that uh the breathable baby crib liners pose no climb out hazard but they're horizontal and why would there not be at least sometimes a climb out hazard from your liner so our breathable liners are constructed of mesh that is very thin i said less than five millimeters they are constructed to actually collapse they collapse to less than one inch we have had studies done to compare that to bumpers which collapse to two inches and we found that the um we had 10 items commonly found in a crib which even includes a hard doll and those were about four inches of climb out we've not seen any data to um site that ours prevent present any climb out and are the lowest of the items that we measured and then i would point to nj shears uh recent study that actually found no difference between liners bumpers and a bear crib for climb out pointing to other factors i guess one of the things that we're always trying to do is to figure out how to draw a line in terms of scientific data and uh proper empirical assessment so uh my question is uh how would we draw a distinction about mesh liners that would uh mean that other liners that purport to be mesh liners are not let mesh liners you have a permeability test or a thinness test yeah we actually we do as i was stating the five millimeters there are tests to actually measure that and that's the spacer the spacer controls that um and that we actually use even in our company we bought um a machine that actually test astmd 737 so that is the permeability test for infant bedding that we would suggest a standard around thank you very much miss collier i'm so delighted to see you here and i'm particularly delighted to see that you have a free web based source of data i wish that we had other government entities uh or government funded entities that did the same it's really hard to get fatality data on a timely basis uh from say the national center for health statistics so you are a godsend uh with that in mind i'm curious did you try to assess whether the degree to which there's overlap between the fatality data that you have and the fatality data that cpsc has we we did not because the data that we can see is deidentified including by state so we have no ability to really cross well i we're going to hear from dr thatch but somewhere i seem to recall that he did have some ability to draw a distinction have you looked at his testimony do you have any thoughts about that and i believe that dr thatch got permission from each individual state to have it identified to him so currently when a researcher requests data from us they get it uh deidentified including by state however a researcher can ask for an identified variable and the states have to give permission dr thatch's study occurred before my tenure at the center but i'm fairly confident that's how he navigated that well i would hope that would be how we would navigate that we would take your information and whatever information we're getting from separate sources so that we can have a fairly clear idea the degree of overlap but again i'm so delighted to listen to your testimony um i would like miss februck uh you you made a statement and i i just want to make sure i understood it you said that only half of the deaths from crib bumpers could be avoided with the use of mesh liner and that goes contrary to the testimony we've heard did i misread what you said uh yeah i did not have a chance to raise that point but in the um the cpsc reports um staff response to record of commission action on crib bumpers in september 16th it not only verifies that vertical crib liners would have prevented four possibly six of the nine deaths um had they been used instead of the traditional crib bumper the other situation vertical liners couldn't not be used but it did confirm that in five of nine cases continuous mesh bumpers presented the same strangulation and hanging hazard as a traditional crib bumper uh miss lesh may i i don't want to get into a debate but i'm just curious if you have a reaction to that i i'm sorry about that um i haven't looked at their particular citing that you're talking about a minimum may i ask you that you do examine the testimony uh and that if you have anything additional to add that you would say yeah i absolutely um one of the things miss februck that uh i'm curious about is i don't see that there are any limits on the thickness of vertical uh bumper pads do you think there ought to be some limit to the thickness because i could imagine somebody getting carried away with the notion of a vertical bumper pad and introducing a level of risk we actually have the patent on the vertical crib liner so we are the only makers of the product and we make them consistently uh at that at that same level of padding which we find is an ideal padding um so it's illegal to sell them uh under the patent guidelines i would not presumed to be an expert on patent law but it is interesting to hear that you have uh that uh that patent and maybe that would present prevent that um and again i just need to be absolutely certain is it your contention that never ever has there been a an injury or a fatality associated with a vertical crib liner that's absolutely correct and they've been on the market since 2008 since for 12 years um i really appreciate that um and um i can't believe those are all the questions i had because i thought i had uh a million of them but you've actually answered so i'm going to defer now to uh commissioner k thank you mr chairman and thank you as well to the panelists i think it's been uh extremely helpful uh i wanted to start with uh miss collier if i can is there a mechanism in your system by which we can i receive alerts when there are new incidents that you've categorized with bumpers that's a great question commissioner k we do have a variable in the case reporting system that asks if um the death might have been attributed to an issue with a product and then there's some subsequent questions that appear we provide extensive training to all of our teams around that variable so if they're checking that variable we're encouraging them to report that back to the consumer product safety commission staff in their state or region um as far as an automated alert i think you know that's something we could discuss uh how that could occur well i think that and i don't want to speak for the staff or the other commissioners but i know that my office in particular we would like to figure out a way that's not burdensome for you that we could at least figure out how we could hear about more incidents and and see where the numbers are going we'd be happy to have that conversation that'd be great we'll follow up with you thank you so much miss jacobson thank you as well for your testimony and certainly your personal experiences as well i was curious to know what your opinion of the mesh bumpers and the liners are at first candle um we follow the american academy of pediatrics recommendations um my feeling in particular and again i'm not a scientist i'm not a researcher is it's the the breathability factor and in my opinion if if something's breathable um then it would be used by the parents i think more importantly though is um the fact that many people have stated here is parents want a solution parents are exhausted and whether there is a imminent danger of harm they perceive there's a danger of harm in um their entrapment or or using you know getting limbs entrapped so they're going to use something um so i think it's important to have something that will give parents a sense of comfort but at the same time be safe that's fair and well said thank you for that um miss lash on the question uh you mentioned in response to chairman others question that you have a permeability test i think more specifically what we have been looking for to address a 104 standard would have to do with airflow and coming up with a test method that would accurately and repeatedly measure airflow does your test method speak to them so that's the astm test method and it does report airflow um or it reports cfm the work we recently had done by the environmental controls expert also does create a relationship between the infants airflow and the cfm that's the use of darcy's law which is something that can be looked at in relation to what level of cfm to set based on the infant breathing rates that we're trying to consider i see and certainly if you look at the package if you see gaps in terms of the test method or the test specifications whether it's relying on astm or others please feel free to submit those comments during the rest of the comment period thank you and then miss free brick i want to thank you as well for coming in i think we met a long time ago in then commissioner adler's office when i was a staffer for chairman tenenbaum so it's good to see you again i am watching online i wanted to thank you for pointing out and bringing it to our attention the impact on the regulatory actions on special needs families as a family with a special needs child that i pay particular attention to that and it's not something that normally comes up in our discussions and so hopefully you've given us something to continue to think about as we look at uh properly addressing these issues without impacting families with needs so thank you for that of course uh chairman adler that was if for my questions thank you thank you very much uh commissioner biakko thank you mr chairman um miss jacobson thank you for sharing your experiences with us it takes an incredible amount of courage and i do appreciate that i do agree with a lot of the things that you said uh no matter how educated you are no matter what you know parents do look for a solution for something that they perceive i can't tell you how many things that you know the the one that just jumps into my mind is you're not supposed to put whiskey on a baby's gums but man if that baby's crying you'll try anything and you know i i'm not advocating for that of course but i i do appreciate that and and you know as i was sitting here and watching one of the slides that came up and i can't remember who put that up there the um hospital crib was very brought back some memories my my little one was in the hospital and you know i put a bunch of stuff in that crib to comfort her nobody in the hospital ever told me to take it out which i i think it's kind of interesting and i have been going through pictures lately for another reason and look when i came to this job i realized all the mistakes that i made as a mother and there are a lot of them um and i'm not i can't remember back that far whether i made them on purpose or i just didn't know but you do make mistakes and we do have to make sure that we we account for that um because we are going to have parents who do take the to take steps and to do take things into their own hands so i i do appreciate all of your comments in in that regard and miss fee brick i also like commissioner k that the special needs kids issue is something we don't think about enough they are yet another vulnerable population that we have that we are supposed to consider children uh just children or just babies are not the only vulnerable group of consumers or product users that we should be looking at and i thank you for bringing that to your to our attention because i hadn't really thought about it from that perspective it's a very good point um we we hear from them all the time and they are looking for an answer they really are make sense we get long letters written to us about what a difference the product made for them X it's an excellent point um miss colier have a couple questions for you um do does maryland participate in your um program it does so i'd be interested to know my last question if there do you have data um on just maryland i mean can i get on there and look all that up so as i said states retain the right to their data um and the case reporting system does not have a public interface where people can query data we connect them with their state um if they're interested in state specific data we connect them with that or we provide analysis we'd be happy to talk with you about a way to look at that data okay because you know i agree with commissioner adler's i was going to ask the same question of whether there was a comparison between your data and and what we looked at because there has to be i find it hard to believe there wouldn't be some overlap um and i'd be interested in that and which brings me to my next question you haven't hear that you identified a number of deaths where a bumper pad is indicated as involved what does that mean exactly as involved so when we looked at um a number of variables we looked at the relationship of the bumper pad to the infant's airway so if the infant was found let's say on their back in the middle of the crib um and the airway was noted as um unobstructed we wouldn't consider that to be the bumper pad was involved it's really what we looked at were cases where the bumper pad was not only present but in a position that it could have contributed to the infant's death so those would largely be cases where it's noted that the bumper pad partially are fully obstructed the infant's airway and would um in those cases did you consider whether there was a space for example between the bumper pad and the mattress or whether there were blankets or toys or other other factors so we would look at those cases and we look to see um what was noted in the narrative and particularly if a doll reenactment was done so this is where law enforcement or the medical examiner have the family use a doll to as a way to position um to demonstrate the position of the child so it would be noted in the narrative if there was a gap um or in the photo that they can upload okay so the medical examiner's conclusion is always something that that troubles me because they don't always make a conclusion that is consistent with what we're looking for I mean you could say that someone died of a you know pulmonary embolism but that doesn't mean it was caused by a product or that it wasn't caused by a product so that that particular conclusion doesn't always tell us what what we need to know so I do appreciate that there's um additional points what was the time period involved for the number of deaths you discussed so we looked at excuse me we looked at deaths from 2008 to I just want to make sure that I'm correct 2008 to 2018 from 25 states so although 45 states use the case reporting system some do not allow us to use their data for research so just 25 states how do I know what those 25 states are um we do not identify states without their permission so if you wanted to know what 25 states those are we would go back to them and ask their permission what why is that just that a curiosity uh we recognize that the data put into the case reporting system contains a number of identifiers it's also very protected data under a number of laws we also recognize I myself as a mom um I would want to know that if my child's data was in here it was very hard to identify my child and use that data EII type of thing okay it's helpful um does your data oh what are the five states that don't participate sure so they're Kansas North Dakota Maine Vermont and North Carolina is there a particular reason I'm just curious yeah so the main reason is that they have legislation that prohibits them from sharing data with an outside entity in fact two of our staff are in Kansas right now testifying before their state legislature to help them change their law okay thank you um miss loesch I you mentioned something that caught my attention and that was with regard to mesh on play yards how does your particular product compare to mesh on play yards sure we actually use a few different mesh but the primary mesh that I uh referred to in the slide was a classic mesh and that's very similar so ours range anywhere from three to five millimeters play yards may be a little thinner but they're constructed in the same way and the one thing about spacer fabrics to note is it's not necessarily the thinness that can contributes to the breathability if you imagine a 3d structure it's the interaction of the holes in the spacers and actually the angles of the spacers so it's a very similar type of mesh using the same construction process of warp knitting I would assume but I don't know that you've made some comparisons in the data that's out there because there's a decent amount of data out there for play yards comparisons to um injuries uh whether there have been any deaths um whether the testing standards are the same yeah so and we actually test our mesh to play yard standards on force and that's why we set those holes the way they are so fingers and toes can't can't get caught in the mesh all right I think um I think that's it for now thank you very much we're doing great on time commissioner Feldman thank you and again thanks to everybody on the panel for being here today this is a useful discussion and and hearing about what you're uh working on in terms of products and and research is is really useful to CPSC as we grapple with these issues um I had a number of questions and I'm not exactly sure where to start but um I think I'll start with you uh Ms. Feebric