 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. I'm honored to be on this panel with these experts on child safety. 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. Feebrick um so looking at the vertical liners and the way that you're marketing your product the price point um sort of your target audience in terms of focus on special needs do you consider yourself to be in the same product category as crib bumpers I think at times we serve the same purpose um but really hearing how um the first panel believed that crib bumpers did not serve a use after six months it that distinction is is so great compared to our product and the use of our product and then and the parents that purchase it um that's I mean that's definitely a distinction is the the limit of use and the primary use of it um and um I think the number one distinction as well as whether it's continuous or non-continuous basically horizontal versus vertical okay so you you think that you're in a distinct product category but have concerns that you're you may well get swapped up in a broader regulation that's been our goal I mean our goal is to provide a solution to a traditional crib bumper we had to market ourselves sort of in the same category this is an issue we constantly deal with retailers they're putting us in crib bumpers we've had to go we are actually in the state of for the state of Maryland Amazon um has still a few of our products based simply on color um that are not exempt uh so we are being tormented by these state bands because we're constantly having to work with the legislatures and um show the exemptions to the retailers because we are different sure uh but the discussion that I'm hearing today and Ms. Losha I want to get to you as well um the the experience that you're having with your sales data and and marketing of your products does speak to what the consumer demand is for the product yes and uh I mean we constantly get calls it's like a hotline people wanting our product people are confused uh and and well actually a lot of parents that we just we talk to know that they cannot use a traditional crib bumper so they're calling us for a solution because they know they can't use the other one um so let me let me ask it another way um I heard that uh that that both Breathable Baby and uh Go Mama Go designs have been successful in seeking a carve out or special treatment under the Maryland ban for instance or in in New York in those states where there's a state ban in place uh and I think this speaks to sort of the elasticity of consumer demand what are you seeing in terms of in terms of growth or not of of of sales of your products in the states where you can buy them but but there's a broader bumper ban in place I think New York is going to be the biggest changemaker we should see a demand we haven't quite seen that just yet I mean it's going to be probably a slow increase not going to happen overnight um also because we sell third party as a whole seller to amazon buy buy baby walmart and we don't know sometimes where those products are going sure but um you know as we do see it uh and I think with Maryland the fact that the infant mortality rate is going down um it within this special situation while my product is still available uh you know proves that I'm not having enough uh a negative effect on that it's strictly positive miss leisure you seem similar we haven't seen anything that would statistically say that is driving incremental demand um I will say however there if you look at amazon reviews so we also sell on amazon um you see parents commenting on with the ban which are from those states so you'll see some comments like that on amazon so people are aware I don't see that it's driving you know significant incrementality by way of you know moving demand from bumpers to liners I think what why that is is that people are becoming aware when a state law is passed that there's some other considerations that bear or some other considerations that um should happen but you're seeing would be bumper customers expressing interest and demand for both of your products correct okay um I want to get to miss collier and I want to be respectful of the time I'm glad you're here and I'm really interested to hear about the work that the national center is doing um and the cdr teams and the work that your fetal infant mortality review process has to bear um sort of echoing what commissioner biaka was getting into um and sort of harkening back to the conversation that we were having on the first panel um I think for the purposes of this discussion it matters what we're seeing in maryland um because uh that I heard it characterized on the on the first panel that yes there's maryland data but it's confusing um I don't I don't know that that supports a conclusion one way or the other with respect to the efficacy of the maryland band so I would ask it if this way has maryland allowed any of its data to be deidentified um I would have to go back and check with 45 states using the case reporting system and all the nuances I don't have it all off the top of my head but I'd be happy to go back and look at what their allowances are okay I appreciate that because I think that's a missing piece of information that would be incredibly useful for us to take a look at um the other question that I had uh had to do with so what your cdr teams are finding and how you deal with whether or not there's medical reporting bias with respect to a number of these incidents I couldn't think of a more traumatic experience than to to to come and find a situation where there's a positional asphyxiation death um but when you're dealing with that and when there's victim families that are involved particularly in instances where those fatalities are occurring where it's sort of a demonstrable lack of of compliance with any of the aap or cpsc safe sleep recommendations is that reflected in in reporting bias that that those fatalities get coded a certain way so I think that we see bias in how death certificates are signed regardless of what type of death we're talking about I think what is unique about child death review teams is that they have the opportunity to put together this multifaceted picture of what happened and so what we often see is that they uncover and expose those biases that are inherent in our systems so as a community they can talk about them and they can provide education and training to try to overcome them your point about vicarious or secondary trauma for our first responders is one that is near and dear to my heart as a mental health clinician we know this work is so challenging for them we provide a lot of coaching and we hear particularly from law enforcement that fatality review teams are the place they can go and they can let their guard down and talk about how hard it was right it you know back at the station it's just a part of everyday life but in this prevention oriented group they can have a place to share the challenges and again that's just a unique facet of this work well it's important work that you're doing I hope you continue it I have no further questions but I thank you all for being here I'm sorry miss Jacobson if you wanted to that's okay I wanted to comment on that Barb Himes who is our director of bereavement and education is in Indiana and she sits on the Indiana fatality review board and you're absolutely right there is a lot of bias and especially when you're looking at coroners in certain areas very small communities very tight knit communities there's a bias quite frankly when it's a non-hispanic white and they don't want to say that it's accidental suffocation as I said we have many people in our support group who feel guilty as it is on the other side when it is non-hispanic black there is a lot of time where DCF will get involved and there is so there are those challenges I will also tell you that in the time when there is the between the time there's the autopsy and the death there's a lot of chatter online of it has to be SIDS it has to be SIDS and then they're posting the pictures of their baby in the crib with bumpers and blankets and everything else and it just makes me cringe I think that that highlights yet another challenge that that we're gonna have to grapple with as we're as we're addressing the issue and making decisions again appreciate you all being here and and sharing your testimony thank you we can't thank you enough it's another terrific panel we are now going to take a lunch break and we will set aside almost an hour it's about 12 36 according to my watch we will reconvene at 130 so again we thank the panel very much while we're waiting for the panelists to be seated Commissioner Kaye are you still with us yes I am thank you okay Chairman Abbott terrific thanks okay we're going to begin the third and last panel of the day you see that no one is sitting in Dr. Thatch's seat that's because he's going to be in touch with us via telephone so Mr. Dickerson if you would like to proceed so good afternoon everyone I'm James Dickerson PhD and excuse me Dr. Dickerson it's okay I earned it but my head's not that big I'm the physicist I'm also the chief scientific officer for consumer reports and I like to thank the CPSC and the commissioners for giving us the opportunity to speak to you today about this topic as you may know consumer reports is an independent organization that's been around since 1936 and in our mission we work with consumers in the marketplace to make sure that the world is fair safer and more transparent on this topic of safer particularly regarding safe sleep we find the issue of crib bumpers to be particularly concerning so as I've mentioned our issue is that that our issue is that we ensure that safe sleep should be at the center of that's usually me so we're very forgiving at the moment that's right no worries no worries so consumers particularly families parents and caregivers have in their minds that products that are available to them in the marketplace should be intrinsically safe they have this expectation and that every product that they're available to them has not only intrinsic safety associated with it but someone out there in the world has verified that those products are safe we know that's not necessarily the case given the fact that there are products that have been attributed to injuries and deaths in this case to children and so it is our contention that the marketplace ultimately fails families and children when unsafe products particularly unsafe sleep products remain available to them for purchase now if you think about it well-meaning parents well-meaning caregivers can have the intent to purchase something that will make their children their infants their toddlers safer but in fact because they believe that these products are intrinsic intrinsically safe because they're available in fact they might be doing exactly the opposite of their intent even though in their mind they're trying to do the right thing and so from this point of view consumer reports asserts that crib bumpers as a product category contribute directly to unsafe sleep practices and unsafe sleep environments that really can be prevented there's from previous panels during this forum there's been a multitude of evidence that's provided I have no intent to reiterate that which is already in the public record but it's clear that many organizations concluding AAP believe and provide data science that crib bumpers really have no place in the marketplace even data from the consumer product safety commission staff indicates that there are a number of fatal incidents as well as injurious but non-fatal incidents that are tied to crib bumpers consumer reports own investigation identified 23 fatalities during the 2012 to 2018 period that were linked directly to crib bumpers and so our assertion is that this data is present data is unequivocable and it's quite clear of the potential harm to children because of these products another issue that we have to consider is that the consumer not the educated consumer that is completely knowledgeable about all of the nuances all the the data that's available from government or other entities in the marketplace about the state of crib bumpers but the average regular consumer are wholly confused by the messaging that's out there messaging of bare as best the messaging of safe sleep but then information that they may receive about injuries and deaths associated doctor dickerson excuse me one second somebody who is on the line it's either commissioner k or dr thatch we can hear rustling and breathing on the phone so if we could ask you to mute your phones that would be helpful and I apologize we'll give you an extra 10 seconds no problem at all so in knowledge of this consumer reports decided to do their own investigation so we have a standing panel of a thousand consumers out there in the marketplace and we identified of those thousand panels that we engaged 240 of them identified as parents and so we wanted to ask them what they understood regarding safe sleep regarding crib bumpers and regarding best bear as best those messaging so what's the interlacing of those three concepts and what we found was that 73 percent of parents believe that bear as best message makes sense with respect to infant sleep safety however a little bit lower than that only 55 percent of parents believe that it's unsafe to use crib bumpers with regarding safe sleep so there's a gap between those that say bear as best make sense but crib bumpers are okay too so we we found a gap of about 20 percent and we feel that that gap of 20 percent that have an understanding of bear as best conceptually but also don't see crib bumpers as a particular issue might be a notable issue that we we all in the marketplace all parts of the marketplace need to address and we also need to address it in terms of our messaging clarity consistency and conciseness in our messaging we're aware that states stores the distributors of products the house of representatives all recognize risks associated with crib bumpers as it's already been stated during today's forum states like Maryland Ohio and New York state of all abandoned crib bumpers and other states are considering legislation associated with this the U.S. house has passed the safe sleep for babies act last month and we can report holy support that bill and hope that there's notable progress when it goes to the Senate to be somewhat critical of the CPSC even though we see the CPSC as partners and many endeavors we feel that we and other of our partners in the space have called for quite a long time for the prohibition the removal of crib bumpers from the marketplace but unfortunately there hasn't been to our mind significant action for years and years and years on this particular issue so we're here to again apply pressure to the CPSC and others to help us ensure that these products are ultimately removed from store shelves we believe that the hard work that CPSC staff has done has invested in the briefing package is greatly appreciated so we are here to partner in that respect to provide as much support as we can given that briefing we think is a very strong step forward but the issue is is that the proposed rule as we see it is quite intricate and complicated but ultimately isn't strong enough and so it's we'll give you an extra 10 seconds again all's good I used to be a professor so I'm used to lots of interruptions so no worries at all we believe that the weakness of the proposed rule could end up leading to greater confusion and ultimately additional delays in having a resolution on this matter something that we feel given the severity of this topic that any delay uh is too much of a delay we really want to see resolution as soon as possible so to conclude a multi component uh 10 minutes uh crib bumpers in our point of view should not be for sale full stop let me say it again because maybe it was not clear crib bumpers should not be for sale full stop we thank you very much for the opportunity to speak to you be happy to answer questions uh and again thank you for all of your your efforts thank you uh commissioner k questions uh I don't think it's actually my time I think it's after the next witness oh my turn no no I'm sorry strike that yes next witness sorry got a little distracted there good afternoon I'm Kelly Mariotti executive director of the juvenile products manufacturers association I'm also a mom former owner of a baby products manufacturing company that made among other things cribs cradles and soft goods including bumpers and I'm also the former ceo of first candle and a longtime board member an organization we heard from earlier today the issue of safe infant sleep has been a common thread throughout my career and I've had the unique opportunity to consider it from a variety of perspectives about 3600 American babies die in their sleep every year for reasons that remain mostly elusive eliminating those deaths is a personal passion and a goal we all share jpma is a national not-for-profit trade association representing 95 percent of the prenatal to preschool industry including the producers importers and distributors of a broad range of childcare articles that provide protection to infants and assistance to their caregivers jpma collaborates on programs to educate consumers on the safe selection and use of juvenile products promoting baby safety is a key mission of the association in may of 2012 more than seven and a half years ago jpma petitioned the commission requesting that rulemaking be initiated that defines and distinguishes between hazardous pillow-like crib bumpers and non-hazardous traditional crib bumpers cpsc voted in may of 2013 to grant the petition and directed staff to initiate rulemaking to address the risk of injury associated with the use of crib bumpers and to provide the commission with a briefing package that described the possible regulatory options the commission could take to address the risk of injury associated with these products four years later in a report dated september 9th 2016 titled cpsc staff response to the record of commission action on crib bumpers was released you've heard from several people today that consumer demand for these products does exist and it exists to solve real problems the report itself stated that crib bumpers are generally used as promoted as providing two safety benefits preventing infants from getting their limbs caught between crib slats and protecting infants from impacts against the sides of a crib during rulemaking activities for full-size and non-full-size baby cribs cpsc staff found that infants getting their limbs caught between crib slats accounted for many incidents involving cribs and bumpers likely prevent some incidents and injuries involving limb entrapment the staff also stated that eliminating crib bumpers might result in some caregivers using soft bedding as an alternative protective barrier against the crib structure because consumers have been known to engage in similar behaviors even in the presence of contrary warnings in the sleep environment this report also concluded that 72 of the 107 reported fatal incidents are unlikely to be addressable by commission action thus improved performance requirements or even a ban are unlikely to have had an effect on these deaths in contrast nine of the 107 reported fatalities are likely to be addressable to some degree some portion of 26 additional fatalities may or may not be addressable by action cpsc's report did not justify a ban on crib bumpers further the conclusion noted that finding that crib bumpers present an unreasonable risk of injury would likely prove difficult although this finding would be required to pursue rulemaking under the cpsa or fhsa on october 19 2016 believing that rulemaking could be justified the commission voted to add to its fiscal year 2017 operating plan a direction to staff to initiate a rulemaking under section 104 of the consumer product safety improvement act of 2008 cpsia crib bumpers are not listed among the products in section 104 f yet using the 104 process allows for the regulation requested by jpm a in its 2012 petition and desired by many stakeholders commissioner adler wrote a very well thought out and clear opinion justifying regulation under 104 section 104 b of the cpsia requires the commission to first examine and assess the effectiveness of voluntary consumer product safety standards for durable infant or toddler products in consultation with representatives of consumer groups juvenile product manufacturers and independent child product engineers and experts and promulgate consumer product safety standards for durable infant or children's products section 104 f1 of the cpsia defines the term durable infant or toddler product and specifies 12 categories of products that fall within the definition the commission's fiscal year 2017 operating plan directed staff to propose to amend the definition of durable infant or toddler product to include crib bumpers note here the contrary to testimony this morning stating that no one is testing these products there is much testing and research done on crib bumpers regulation under section 104 will also require pre-market third-party testing be conducted pursuant to section 104 b cpsd staff has consulted with the required stakeholders in the development of the npr largely through the astm process astm f 1917 subcommittee members represent producers users consumers government and academia utilization of astm safety standards is recognized as an effective approach to address consumer hazards especially applicable to juvenile products staff began the consultation process for this rulemaking in december 2016 in a letter to astm requesting that the f 15-19 subcommittee on infant bedding form task group make improvements to the standard related to three areas firmness requirements airflow requirements and morning and instructional requirements and to initiate activities to update astm f 1917-12 with more stringent requirements that will further reduce the risk of injury associated with crib bumpers since then cpsd staff has been actively participating in the astm subcommittee activities to address these issues the updated standard to be published shortly includes most of the staff recommendations cited in the september 4th 2019 proposed rule and briefing package in this regard we recommend that the rule voted upon should reference astm f 1917-20 jpma's position is that all crib bumper pads and liners should already meet astm voluntary standard requirements per astm f f 1917 and that caregivers using these products should always follow the instructions of the manufacturer and heed the warning and usage statements the risk factors noted by dr. thatch in his original study which was based on data from 2005 and prior have already been addressed in this version the evidence on the record indicates that notwithstanding improvements to the astm standard as a legal matter based upon the record and previous vote of the commission the commission would have been justified in acting earlier and approving a mandatory rule based upon astm f 1917-12 however in an ongoing effort to create the safest products and to support the rulemaking process for which we petitioned jpma has taken a lead in discussions to further enhance f 1917 and has worked diligently to facilitate collaboration with the cpsd human factors staff betting and crib bumper manufacturers and other parties participating in the process as the astm process is one of continual improvement we will continue to champion improvements to the standard including additional performance requirements such as air permeability thresholds following the section 104 process through astm astm can accomplish this much more quickly than psc rulemaking commissioner k said earlier that we may ask today what has taken so long and indeed that is our question the failure of the commission to act in a timely manner is troubling jpma petitioned for rulemaking to set uniform national standards for crib bumpers has encouraged the expediency of this process since 2012 it has languished for nearly eight years continued inaction by the commission is not justified while reasonable persons can interpret data differently this seems not to be the case here unfortunately there appears to be an effort to altogether ban products rather than establish reasonable standards for products as required under the very law the commission voted to proceed under more than three years ago we would also like to take this opportunity to urge the commission acting in conjunction with other agencies at the federal and local levels to vastly improve efforts related to education on safe sleep practices our own review of cdc data indicates it is difficult challenge to reach new caregivers who rapidly transition into and out of periods of time caring for newborns and infants while challenging it is increasingly important to focus on behavior and use conditions in the care of newborns jpma will happily partner in all efforts related to safe sleep education in conclusion jpma is not aware of any new signs that would justify a ban on this product category since the 2016 cpsc report and notes that the current astm standard has effectively removed hazardous pillow-like bumpers from the marketplace dramatically reducing any risks associated with the product we appreciate and share your interest in child safety and we welcome the opportunity to have a collaborative dialogue about ways to educate parents and caregivers about proper selection and use of juvenile products including crib crib bumper bumper pads and liners thank you for your time thank you very much dr shears now i'm you know i have trouble walking and chewing gum at the same time one of my supposed to do for the presentation is it on this computer i got it for you talk to the gentleman next to you this green server just came on let's take care they miss you too barb could you bring me another phone this one just died no there it goes he had to go and fix it and back in the room back there we're not going to stop start the clock until you're ready and i think i hear an unmuted phone again so may i urge whoever is there with an unmuted phone to mute it thank you good afternoon uh thank you for having me my i'm nj shears i was the staff member of cpsc for 26 years i miss you guys uh and i thank you for letting me review crib bumper deaths so my purpose is to compare the the staff's review of bumper deaths with diagnoses by the medical examiner and pathologists uh there were 43 deaths that they evaluated in 2016 that brad thatch and i also evaluated and uh were published in the journal pediatrics before i go on though i'd like to talk about the subvocation mechanisms uh the first and most frequent is wedging uh where the infant gets stuck between two surfaces and can't get out if you remove one of those surfaces like the crib bumper the wedging doesn't occur the second the second mechanism is face against the bumper without um wedging it's called lethal rebreathing so as the infant uh breathes into soft bedding oxygen gets depleted carbon dioxide accumulates and the infant rebreats the carbon dioxide and suffocates the third method is strangulation when bumper ties there's very few and we won't talk about them here now the team uh at cpsc evaluated those deaths and disagreed with the medical examiner on 34 deaths agreed on three deaths and agreed on six deaths that the medical examiner called sids uh brad thatch and i reviewed those six deaths and thought they were likely to be suffocations but you know that was non-medical exam or diagnosis so i'd like to tell you why i think the best evidence for how the deaths occur from the medical examiners one is they're on the spot they're there when the deaths occur and cpsc can review those years later some of them are years old uh the me's investigators do the scene they ask the parents to place the doll the way they've seen um the way they found their infant and they also do the medical examiners do the autopsies and cpsc staff disagree with those diagnoses from the autopsies so the me's are the primary source of the data uh they do the autopsies the investigations the death certificate they are the official word uh and so cpsc is reviewing information primarily from the medical examiners often they said the data was unclear or conflicting but to my knowledge they did not contact the medical examiners to talk to them to ask why uh or what was uh going on finally um the me empathologists are physicians they're trained in uh they have specialized training in uh diagnosing manner and cause of death uh and cpsc staff is does not have that specialized training and there are no physicians on cpsc staff so what i'd like to do now is go through about seven cases depending on my time and um these are cases where i put on the slide for your reference uh quotes from the death certificate autopsy and investigation i'm not going to go through those but i'm simply going to try to say what was the logic that the staff used to come to their conclusion uh in this case they said they didn't know if the bumper caused the death and the logic was uh there's no autopsy well there was because when i was on staff i put it in the databases uh the baby was sick uh but the pediatrician uh said the illness wasn't severe enough to cause his death and finally that this seven month old was developmentally capable of moving its head and getting fresh air but that ignores the arousal literature hannah kenney at harvard studied cid's brains and found an arousal deficit so if this baby had an arousal deficit it would not have moved its head in this case the team said it was unlikely that the bumper caused the death uh and uh the logic was the police and the father did not say the baby was wedged but the medical examiner did well this is a kind of wedging it is two surfaces the pocket is deep enough that the baby gets into that pocket and can't turn its head so it is a form of wedging uh they also said the blanching and lovidity patterns suggest clearly suggest that the infant was horizontal uh prone horizontal on the surface and face down we would argue that the blanching lovidity uh it could also say the baby was prone but face to the side and they felt that this soft padding was uh the dent in the padding was likely incidental and of course we disagree with that in this case it they felt it was unknown if the bumper caused the death this was a wedging the wedging was between the nursing pillow and the bumper and they said well the baby's face uh we don't know if it was into the pillow or into the bumper well it's a wedging it doesn't matter if the baby's face is into the nursing pillow and the crib bumper is keeping it there if you remove the crib bumper there won't be a wedging and the death won't occur this is another unknown where the staff felt that there was a comforter and they didn't know where the comforter was was the baby's face pressed into the comforter or into the bumper but in the case files the medical examiner uh noted the comforter but didn't say it was contributory in any way but again uh staff didn't call the medical examiner to clear this up uh another we don't know why the baby died uh and oh excuse me this was summarized in the 2016 paper with some others but it it was said there that they we don't know the orientation of the face relative to the bumper uh clearly the medical examiner said decedent found in crib with face between bumper pad and mattress but i put this up for another reason uh in the 2013 report there was um a lot of mention of clutter in the crib and there was a lot of clutter in the crib no one likes clutter again we want to get it out of there of course but if the clutter is not between the nose in the mouth and the bumper is irrelevant for that particular death uh again uh we don't know uh let me see we don't know the exact position of the baby's face but again we didn't communicate with a medical examiner or pathologist to find out why they said what they said face wedged against bumper and mattress of crib this is the last case and this is one where the staff uh i think misinterpreted the picture that is not a death scene recreation that is a picture of the death scene but not a recreation i called the medical examiner and talked to her and she said they never took a recreation picture so uh and in 2013 uh the staff said uh they were entrapped the baby was entrapped by a sleep positioner with back towards the bumper covered crib side uh that is not correct according to the medical examiner and so um our recommendations are to ban these padded crib bumpers uh we think the staff analysis is flawed uh the medical examiners diagnosed a lot more uh deaths of suffocation than the cpsc staff the staff didn't communicate with the medical examiners or pathologists when the information was conflicting or unclear and we think the best evidence for suffocation is from the medical examiners okay and now sir if you could help me do another presentation we now have Brad Patch can you could you get me up with another one uh let me ask our tech person rock if you could come out and set up dr thatch's slides thank you yep should be thatch yes okay so you're going to be changing the slides for dr thatch i am okay good uh doctor thatch if you're there uh we look forward to your testimony another database the national center for fatality review and prevention is abby collier can you hear me yes showed in her talk identifies more crib bumper deaths than the cpsc cpsc did not include these deaths from the national center in their review there were 37 states in the national center's network from 2008 to 2011 there were reports of 32 deaths from these states from the same time period the 2008 to 2011 cpsc has 13 reports of upper deaths primarily from deaths of certificates collected from all 50 states all three deaths were from the same states combining these deaths from those uh two sources increases the number of crib bumper deaths to 42 for the time period 2008 to 2011 over three times the number of deaths identified by the cpsc then combining the 42 deaths with the 35 deaths we identified before 2008 results in a total of 77 deaths further the cap would be even higher if the national center had cases before 2008 cpsc's firmness test is not unreasonable but there is no date on how firm the bumpers would have to be to prevent carbon dioxide accumulation of concern this uh is that babies tend to accumulate carbon dioxide uh and legally reduce oxygen around the baby's phase quickly and easily in 1998 the cpsc staff used a mechanical test to measure rebreathing in comforts and found infants could have died while rebreathing also the firmer the bumper the more likely it is to occlude the baby's phase in 1998 the health science uh the laboratory staff used a mechanical model to measure carbon dioxide accumulation and legally reduced oxygen in comforts they concluded their test shows infants could have died while rebreathing now uh something else we concluded a uh conduct a survey of mothers who subscribed to parent parenting magazine this is nj and myself about 70% use crib bumpers 20% mesh liners and 63% i use no barrier in the crib there were too few mothers who said they used vertical bumpers to analyze mothers were asked to rate the items and why they use crib bumpers mesh liners or nothing in the crib almost the rating range from strongly rate to strongly disagree almost 60% of mothers who use crib bumpers use them because they are safe with almost 90% doing so to prevent side entrapment or head or hit heads against the slats flat entrapment and hit heads are more likely to occur in older children at least 50% of mothers who did not use a crib bumper or mesh liner in the crib also worried about flat entrapment and hit heads therefore the data suggests that mothers are unlikely to be labeled to remove crib bumpers for older children i'm sorry and uh recommendation that we made is there is substantially more deaths from crib bumpers than have been found in cpsc databases the proposed firmness test is unproven while waiting to determine if the firmness test is effective more deaths will likely occur 12 years and also 12 years of warnings have not reduced uh crib bumper deaths so that's all i have to say well we thank you for that and we now have moved to asking questions and i will uh lead with questions and dr dickerson i did want to uh note that i saw you on a netflix uh documentary talking about tip overs and i thought you did a marvelous job so again another good job today i guess my question to you would be uh do you have any data that as does consumer reports have any data or opinion about the usefulness of mesh liners or vertical vertical crib bumpers uh so we have no data specifically on vertical crib bumpers uh we don't have data explicitly on mesh liners however it's something that we are considering uh during our next fiscal year as something to investigate well we certainly appreciate that miss mariotti uh first of all i want to express my appreciation to you nj pma for the cooperative approach through astm and directly with us that we've had over the years we certainly want that to continue and we thank you for your testimony today you do point out that there's been quite a delay in the development of a standard as you can see from the discussion today it's a highly contentious issue that's not necessarily a defense so what i usually invoke is the three-part rule good quick cheap pick two and so it's it's something we should be moving more quickly on and i certainly appreciate your comment there one of the points that you made about removing crib bumpers from the market is what you call the unintended consequence of parents using dangerous soft bedding as makeshift barriers and i guess my question is is that a theoretical uh concern is do you have data that supports that notion one way or the other it's it's not an insignificant concern i'm just wondering what the basis is for making that assertion so the assertion as i cited in my testimony is from the cpsc staff briefing package um it's also something that anecdotally is discussed in a variety of contexts related to sleep and even other types of children's products in terms of the data as to parents using these items and how they're using them most of that comes from reviewing incident reports and seeing that these other products are present in in the environment regardless of the of the product that that is under discussion or the type of of death we're talking um but in terms of hard data as to how many people do this and what's the inclination to do it it doesn't exist i do note however though that when we look at pictures these very troubling pictures of these deaths seen investigations in most cases there are a variety of products um implicated and i think that we can draw a conclusion from that that it is not an uncommon occurrence thank you for that dr shears and dr thatch and i'll start with dr shears uh one of the confounds i think i mentioned earlier this morning when we're looking at uh deaths in cribs is the issue of soft bedding versus crib bumpers and you addressed it to some extent but i'm wondering to what extent do you think that's a serious confound to what extent do you think that crib bumpers by themselves present a hazard uh and do you have any uh suggestions about how we can assess the data uh more accurately well the last part no the data is that's what i was afraid i was stuck with that uh the to me the death is i'm not the medical person uh and i don't claim to be so i'm not going to get into uh some of that but to me if the these are the only holes that you can use with to to get suffocated so if if the product is here and it's a clutter is there that's uh i would argue that that is the bumper and not the clutter is it your suggestion that uh when staff is looking at the fatality reports that to the extent they can they should contact the medical examiner to make sure that that we've gotten at least their best assessment about what occurred with respect to a fatality or is that a resource drain of major proportion it is a resource drain uh certainly because when i was asked to take a fresh look at uh the data uh what i found was our files were very sparse and so i got a list of and and we called the medical exam is very helpful to give you anything and i'd say give me whatever you got in your files uh but uh some things are offline so to speak and the medical examer remembers them but they didn't write them down so yeah i think it's critical to talk to them if something's conflicting or unclear if it's clear you don't have to call but certainly if it's conflicting or unclear you should call i appreciate that um just out of curiosity based on your assessment of the data do you have a sense either based on data or just an impression whether uh deaths associated with crib bumpers are staying stable or increasing or decreasing well when we did the 26 uh paper we saw an increase but we couldn't um we couldn't over time we're not sure what it was we could be just better reporting because people know we're interested or cps i'm not we anymore but cpsc is interested in it and they'll just report more often uh in your 2015 paper you point out that infants still manage to get stuck in crib bumpers either by putting their legs over or under the bumper do you have a sense of the frequency of this did you have any hard data it's just it seemed to be an interesting observation that i hadn't seen before uh no i don't have a hard day i what we did was that's in the complaint database where people call in and say this is what happened to my infant and i want to complain to cpsc but there's no way to get any kind of estimate of the extent of that it just happens so one should know i wanted to ask doctor thatch if i understood correctly uh you have said that uh you did have the ability to compare at least to some extent the data from cpsc from the data for the national center for fatality review and prevention what's your best sense about the degree of overlap what's your best sense of about the number of instances of fatalities that they have versus the number of fatalities that we have uh well that's not quite fair for doctor thatch because whoever i i did that and uh i so this was uh in the 2013 i believe um and at that time terry covington was head of the national center and i called her and she uh said well the only way we can compare is to look at the states and she went and did all the due diligence of getting the state's permission so that's what we did so in this figure what you see is from 28 to 2011 there were only 13 deaths at cpsc uh and from the national center there were 32 deaths from cpsc only three deaths were from the same states so uh this is i think um incredible because if you add all of this together and you get to 77 deaths we don't know how many deaths are out there is what it comes down to is we just don't know but it's a lot more than we thought i'm intrigued that uh we the staff didn't include data from the national center do you have a sense of why that is is there a concern about the lack of quality of the data would well it's it's a lot of work i mean the staff does a lot of work i i i don't know why they didn't contact the center uh one final question do you uh or dr thatch do you have an opinion about the merits of mesh liners or the merits of vertical liners as products on the market well i i think mesh liners are fine i don't think they impose any additional hazards uh and vertical liners would it be the same assessment same conclusion uh i would say so yes okay i appreciate that those are all the questions that i have commissioner k if you're now prepared to ask questions forgive me for calling on you prematurely that's okay thank you mr chairman i wanted to start with uh miss mariotti thank you for appearing i think if i understood correctly you talked about the fact that there's ongoing work at astm on airflow and trying to come up with a technical with technical requirements for that is that accurate yes that is accurate um there have been some studies um done by independent organizations to assess airflow in um cloth bumpers as well um as some of the other products that have been discussed today in addition as we heard earlier there is an airflow requirement in a different astm standard and that work continues it's the um astm is expressed as a group that's next round um that's a requirement that they're hoping to incorporate into the bumper standard i see so where we left it with astm at least my understanding was astm that created had created two task groups one on firmness and one on airflow and from what the staff had reported to us was that the airflow task group felt that it had not really found anything worth pursuing and had closed out its work and so if that's accurate it sounds though that that has been reopened my understanding of the process as it stands is that that work was delayed in large part because the astm standard for um lack of forward progression was at risk of being withdrawn entirely meaning we would have to start over and the group believed that the importance of this work and having a standard that could then be referenced as part of a federal rule um justified forward movement on the areas where there is alignment and data supporting the recommendations that are being worked into the standard and that more work needs to be done on the permeability question and so it was set aside for future rounds i see so do you have any sense of the timing as to when we might actually see specific proposed test requirements i do not have an idea of that timing again we are one of many stakeholders but it is something that is discussed and certainly something that we promote for further discussion got it thank you and dr dickerson if you wouldn't mind please following up on that topic either within the context of work with astm or otherwise do you know if cr has any data on airflow or test methods that would be helpful or is that something cr we consider working on if not so as of today we have no research data or testing data associated with airflow or permeability however given the state of affairs it's something that we are very keenly considering for future investigation right to the extent that it matters uh we certainly support that very much i think that would help significant in this area dr that's i know you're on the phone as well as i am thank you so much for your pioneering work in this area which is the reason we're even here today this 13 years or so after you originally published your study so we're grateful that you're still involved in it and of course dr shears it's great to hear your voice again back at the agency and welcome back i wanted to follow up on something that you were discussing with chairman abler which is this very disconcerting sounds like data gap where there might be full or relatively full files associated with bumper related deaths that our agency really has not gotten its hands on and so could you elaborate please dr shears a little bit more on what it would take for us to get a hold of those files and what kind of assessment we would need to do on them if you're talking about the national centers file i think abby colman said that there is some problem in terms of getting the de-identified data i would have no idea i'm not a part of the center so you'd have to talk to abby but certainly you guys are able to get your hands on enough information to conclude that there were a number of deaths outside the scope of what the staff has looked at correct well no all we did because of the confidenciality agreements we couldn't look at the cases and so uh all we did was say well let's get an idea of how to combine these by looking at what states the deaths occur and the assumption was if it wasn't a different state it was not it was a unique death and if it wasn't the same state it was the same death well that's a little uh lucy goosey but it gave us an idea that cbsc was not getting this data just 32 deaths versus 13 deaths tells you that i see okay well it sounds like at a minimum then that there it might be worth our staff at least taking another shot at trying to get some of this data understanding that there might be difficulties with working with each individual state i have no more questions than thank you to the panelists and thank you chairman adler thank you and commissioner bioca thank you um dr shears i wasn't here when you were here so um i'm sorry i missed you and thank you for your service uh what did you do when you were here uh a number of things i started off in epidemiology and then i went to planning and evaluation uh and then uh i went up to oh i forgot in the other office so so soon uh but i moved around is your background is in statistics correct okay um i just had a couple point questions because i got a little bit confused on the um uh data that you were talking about and what um with this center i i thought that miss collier had said earlier that the the cpsc and the center didn't necessarily compare data is that they don't okay so it so i i think so what you're saying is because they didn't compare the data you added them together assuming they were separate deaths yes i mean we wanted to get an idea of how many deaths were out there and the only way and we knew the center was getting more than cpsc was getting so that's the only way we could add them was to look and see what states were the deaths occurring in and if it was in the different states we said okay we'll assume they're different deaths if they're in the same states we'll assume they're the same states so we'll subtract those out and then we'll just have the unique deaths for the center and for cpsc okay so you made some assumptions what's the um you know plus and minus marginal error in university oh you're getting too smart i have no idea uh but deaths are counts and you don't generally do plus or minus well so on that no i want to i don't i don't want to pick at your slides um because i know that please yeah i know i don't want to go do that because i i think that in some of these cases um there are different um conclusions would you agree with me to reach okay so the one the one that i did want to ask you about though is you um you remember the slide that had the nursing pillow in it yes okay so i you said if you remove the um crib bumper there's no more wedging right but if you remove the nursing pillow the same there would be no more wedging as well absolutely so it could be either or yes or a combination of both we just don't know just all you need is one okay so it could have been the other yeah okay um you also mentioned that um medical examiners um are you like to rely on them because they're md's but um wouldn't you agree that medical examiners are can be in certain jurisdictions elected officials who aren't physicians no those are corners we have a medical examiner corner system and that's why i had in the slides me slash pathologist because the corners have to have a pathologist they can't do the autopsies and they can't do the uh they they the official uh diagnosis comes in from the pathologist so you're right the corner can be anybody just joe smough but um but they have to have a pathologist okay so when you said you picked up the phone and talked to these people did you talk to the corner or the medical examiner i just got confused on what you said uh no uh i guess the people i did talk to happened to be medical examiners uh when i had a question okay that's i just wanted to clear that up um i think that's i think that's all i have right now thank you um working backwards miss ms mariotti um you indicated uh first of all um i don't know what's taken so long and i must confess that i'm not a big fan of the speed in which government that's been one of my biggest frustrations coming from private practice how slow everything is so i i feel your pain i think we all do and you mentioned uh just on that point that we should be working with other gate uh other agencies to get that message out they're not going to speed things up either but your point is well taken um but on that point um you you mentioned that um jpma is part partnering with different agencies including the cpsc with regard to safe sleep what are you doing um as far as getting that message out and what kind of um how did you measure if at all your success getting that message out um so we have as have you been in contact with a variety of different agencies and i think that we will all agree that getting the message out is very very challenging in large part because we don't have a consistent message part of the reason that we're here today part of the reason that we would like to see a uniform national standard on this topic because consistency in messaging is certainly going to lead to better efficacy um we are able to um track um certain behaviors um through data that is widely available um where we do see that messages such as back to sleep do continue to resonate um we also work with our manufacturers to promote safe sleep messaging and in a very grassroots way often um several manufacturers do have their own initiatives where they um go into communities and work through different nonprofits to donate cribs um talk about safe sleep talk about ways to um best practices in terms of of safe sleep messaging um but we do believe that that uniform standards do help um tremendously so that we're all speaking the same language when we go out there in the world and and spread the word are you working with the medical community at all we would love to work more with the medical community certainly we keep um an open dialogue um as much as possible um as you can see today sometimes we we don't um agree on the analysis of the data or the the way forward even if we do agree on the data sets and the progress but certainly um jpma always supports campaigns that um that encourage safe sleep practices we always support the NIH recommendations and again work with a number of different partners um and always like to try keep that dialogue open i'm a big advocate of starting in the middle because i believe that no matter how diverse views are there is a middle and we can all agree on and to start there so i i would hope that um on this issue or any other issue that we have diverse views we could start and at least move the issue forward as far as the things that everyone does agree with because listening today i i i've walked away with things that i think everybody agrees with so i would encourage you to to start there um on the um the ASTM thing you said and i hope i got this right that our position is that um ASTM f1917-12 um should address many of the issues is that right so that is correct so we believe that um dash 12 addresses many of the issues it addresses the concerns raised by dr thatch and his original report i'll also note that um just from the visuals at least five of um the pictures of the cases that dr shears showed us today um those products would be banned under the currently existing standard and i think as we look at data um and hear about some of these these deaths and and flush out perhaps additional data sets that we're very mindful of those that come prior to some of the work that's already been done because i do think that the products that were implicated in many of the older data sets are already not in the marketplace and that we need to move forward um from a place of better and more stringent regulation as justified as with any product category well that brings you to my next question and this is a concern i have not with the product we're discussing today but all products and that is how do we police um online compliance because i think another um if you will vulnerable population that we discuss matters with are the people who think what they're buying online is coming from this organization or that organization when it's not and we do know we all know that we're getting products shipped directly to a consumer's home that are not coming from manufacturers or sellers that are complying with the standards how do we deal with that we could have another hearing on that topic um i can tell you that topic is a major agenda item of jpma's as well and it is a very complex issue for the reasons that you note um we believe that a good start our programs like the jpma certification program that is a additional verification that third party testing has been completed um that the products are compliant with all federal rules and are sold by reputable sellers into the marketplace um we're looking at other types of programs that would have similar checks and balances so that those products that are compliant are what's being sold and that those products that are not compliant would be more easily identified yeah i'd be interested to know and maybe this is not the right product but if any of the deaths had anything to do with a seller who was not satisfying any of the standards it may be not applicable here but it is something i think we should consider i think my time is up thank you thank you commissioner feldin thank you very much i'll be brief but i wanted to again express my appreciation for all of you being here and for dr thatch for being available on the telephone um i want to make sure that we're asking the right questions about the data and spend a focus of most of the discussion for what's been a a long day and i'm glad that we've had the opportunity to go into this level of depth but under our requirements if we were to pursue a product ban under section eight we're we're supposed to look at the unreasonable risk of injury associated with that product if we were to pursue a durable nursery standard under section 104 again that's a risk-based inquiry where we're looking at the risk of injury associated with that product when we're talking about making a risk assessment much of the discussion today has been focused on aggregate incident counts and each one of those incidents is is heartbreaking and all of those fatalities are are are are important in particular to the families that experience them um but going through the analysis that the agency needs to conduct looking at risk what i'm not hearing today it's much discussion in terms of exposure rates the data set that we're talking about is over uh a multi decade period of length going back 30 plus years i'm not hearing much discussion about uh the the incident rates in terms of exposure in terms of the number of product in the marketplace is that a necessary part of this conversation um miss mary adia i'd turn that over to you so we would say yes certainly that it is um and i think coupled with with my prior point about um the way the product has evolved since the time that we started looking at these incidents that exposure not just to the product it's a general concept but the product as it exists today in compliance with the current ASTM standard and certainly um as has moved towards the anticipated um additional requirements um i think that um using the precautionary principle um is not founded in this case but certainly um is is what's being advocated i think by by some of my colleagues that have spoken today um versus really using the scientific data to make an analysis of how to proceed i appreciate that thank you um this question is for uh dr shares and dr thatch um in your review of the data and this is going back to a question i've asked on on the two previous panels do you see anything that speaks to the efficacy of the maryland state ban not in our data but there was a study that looked in i guess the northeast and it was uh use of the data and the lowest was maryland the highest was new york new jersey uh so that would be the only uh literature i'm aware of would you mind submitting that for the record so i'd have an opportunity to review thank you um if i may commissioner felton because maryland has come up many times today there was an article in the baltimore sun in march of nineteen um which i will submit as part of our our record um there is not um data attached to it or a study but the title of the article is baltimore just saw the worst spike of sleep-related infant deaths since 2009 um i think that digging into that information might be compelling given the the amount of um reliance we seem to be putting on on or questioning about the efficacy of the maryland ban i appreciate it would you mind submitting that for the record as well thank you um and and i think this is my last question um and it's a little bit off topic uh but but uh miss mary adi given your experience with the the astm standards development process um when cpsc staff participates in voluntary standards development there's a number of criteria that it needs to consider uh before it can participate in the process and that includes taking a look at um some of the procedural safeguards that are in place with respect to the sdo process period or with respect to some safeguards within the standard looking at things like whether the standard excludes to the maximum extent possible um requirements that would have an anti-competitive effect um or that would create a restraint restraint of trade within um market actors that are trying to meet that safety standard and likewise whether the the standard itself has a mechanism for periodic review to make sure that anti-competitive effects either aren't present or or have been addressed and there's sort of a a relief valve on on that front um these effects in my view tend to be exacerbated when uh you have industry stakeholders that are participating in the the development process that owned the particular ip that then becomes sort of the basis for the performance requirement um and and we heard from uh panelists on the previous panel uh that that do own ip in the space and that are actively uh participating in in in the development process um with your participation in astm in your view are there safeguards in place to address those concerns yes we believe they are and i think that the current cases are um excellent examples of of that scenario and by um working through an industry association such as jpma we can have open dialogues um with some of the stakeholders to ensure that we're not crafting regulation that would infringe upon um a certain organization's ip or create a scenario where there is a monopoly um we think that it's been very effective um certainly using performance based standards is is the way around that versus referencing certain proprietary terms or even um terms of common use that would um lean towards infringing on a certain on a certain type of ip but as long as the standards are performance based um typically we're able to navigate those waters and i do find that we do so pretty effectively that's helpful background and i appreciate that i want to thank you all again for being here um well i want to thank all of our panelists and everyone who helped facilitate the meeting uh rock our technician has done yeoman's work in keeping us on track so we really appreciate that uh this concludes this public meeting of the united states consumer product safety commission again thank everybody who appeared