 So, we welcome everybody to the meeting this morning and I want to thank all of you for coming because we know you all are very, very busy professionals in the fields of medicine, public health and advocacy and you've come from far and wide to attend this meeting on crib bumpers because it's a really important issue and we recognize that you believe it to be so and we agree with you. So just a word of history, I think you all know that in May of 2013, the commission granted a petition from the Juvenile Products Manufacturers Association for the commission to address the risks associated with crib bumpers. In granting the petition, the commission instructed staff to look beyond the specifics of the petition request to identify any and all regulatory options the commission might take to address the risk of injury associated with bumpers. In response to the commission's direction on September 12th of this year, CPSC submitted, staff submitted a briefing package to us. In it, as I understand it, staff estimated based on their evaluation of the 100 plus fatalities known to the commission where a crib bumper was present in the sleep environment that on average only about one suffocation death every other year could be attributed to crib bumpers. I certainly appreciate the professionalism and dedication of CPSC staff, but I am aware that other experts in the field have looked at the same data and other information have reached different conclusions about the risk of crib bumpers. It's always been my practice in situations like this to listen to all voices who wish to be heard. So I've agreed to meet with those who wish to comment on staff's analysis, especially with respect to assessing and interpreting the fatality and injury data before the agency. I should also add at this point that last week a majority of the commission voted to commence rulemaking under Section 104 of the Consumer Product Safety Act to address the hazards associated with crib bumpers. Under this approach, the agency can regulate crib bumpers as durable infant products, and we have Nancy Coles here who was very involved in the drafting of Section 104 and we're delighted to have her here so she can make any relevant comments about the advantages of rulemaking under Section 104. As I've said, I want this meeting to be about you, your data, and expertise. I want this to be a dialogue between us and between you, so please don't be surprised if I interrupt you mid-slide to ask you questions and feel free to ask one another questions or make comments as people make their presentations. I remind observers that the only speakers today will be the panelists. If you have questions for them, I'm sure they would be happy to discuss them with you after the panel, either by phone or through email. Let me repeat one point. This is my meeting, I'm not intending to be possessive about it, but I'm one commissioner with a group of outside technical experts. This is not an official hearing of the Consumer Product Safety Commission. I'm pleased that there are staffs of other commissioners in attendance, and I invite anyone who wishes to arrange a meeting with them to do so. I'm sure they'd be delighted to talk to you. As a point of information, because the commission has voted to proceed with rulemaking on crib bumpers, I plan to submit the data and remarks you provide today into the official record of this proceeding once the record is open for comments. So what you say and what you submit will be put into the record. Three quick logistical points. The meeting this morning is being voice cast, but not video cast as we'd previously announced. I want to apologize for that. Please note, however, that those who wish to view, and those are people who are listening in, to wish to view the PowerPoint slides as they're being discussed today can do so by downloading them from CPSC website's public calendar page and following along as the speakers discuss them. On that point, I'm going to ask a favor from the speakers. Will you please reference the slides by number as you proceed? Also, if you're going to speak, there's a little bar on the microphone in front of you, it'll turn a red light on. That means your microphone is on. This is being recorded, and the recording will be placed into the record. And the bathrooms are outside the security desk across the hall, so folks should feel free to come and go as they need to. Again, thank you so much for your time and expertise. I'm eager to hear your thoughts on how best to protect our most vulnerable consumers in their most vulnerable moments. What I'd like to do now is go around with introductions. And I'm going to start on my left with Jen Feinberg. Hi, I'm Jen Feinberg. I'm Senior Counsel to Commissioner Adler. NJ Shears from BDS Data Analytics. Hi, Ami Ghadea with AAP's Department of Federal Affairs. Hi, I'm Rachel Moon. I'm a pediatrician at the University of Virginia, and I'm Chair of the American Academy of Pediatrics Task Force on Sudden Infant Death Syndrome. Good morning. I'm Andrea Aguilin. I'm a professor and director of the Johns Hopkins Center for Injury Research and Policy. Good morning. I'm Terry Covington. I'm the director of the National Center for Fatality Review and Prevention. I'm Nancy Coles, director of Kids in Danger. Sarah Klein, Chief Counsel for Commissioner Adler. And Dr. Thatch, may we ask you to introduce yourself, please? Yeah, I'm Bradley Thatch. I've spent some time writing papers on the crib bumper issue. And I'm Professor Emeritus at Washington University School Medicine in St. Louis. Thank you very much. And now Dr. Shears and Dr. Thatch, we look to your presentation. Thank you. Good morning. Arrow forward. Chew gum walk at the same time. The purpose of this review is to look at crib bumper deaths that we documented in our 2016 Journal of Pediatrics article. We had looked at 48 deaths caused by crib bumpers from 76 deaths that had been originally identified. 43 of these we were able to match to the recent CPSC briefing package. Five bumper deaths we didn't match because they were in the 80s and the CPSC briefing package started in 1990. So for these 43 deaths, we thought 37 that were diagnosed as asphyxia suffocation deaths and specifically describe bumper involvement. So wedge between pillow and bumper pad, face pressed against bumper pad. There were six SIDS and a SUTI that were likely bumper related, head hanging off recliner and face pressed against crib bumper. Now for the 48 deaths, 32 of them we judged were not involved with clutter. Wedging between a bumper and a mattress, 13 of those, 12 face against bumper, three where the arm was caught between the bumper and the mattress side rails with face pressed against bumper, wedge between crib and bumper after a likely climb out and we give our logic of why we think the infant stepped on the bumper and strangulations from a bumper tie. Now there were wedgings with a bumper and I guess you could call that clutter if you want to, it's wedge between a bumper and something else. So pillows, recliners, a co-sleeping twin and one wedged in a crib depression. This was a crib with structural integrity problems but the infant was in the depression with the bumper around her head preventing her from turning her head to breathe. Now the staff review of addressability of the 43 deaths were three were likely, seven with teen were unknown and 23 were considered unlikely. So here are the ones that are likely. I'm not saying the slide I'm on, I'm so sorry. Slide seven. In these cases, the staff agreed with medical examiner and you can see positional asphyxia lying faced down in a bumper, the middle one nose and mouth into a bumper and the third one I had no picture suffocated in corner of the crib against the bumper and you'll notice the middle picture has a problem with the crib, the crib is broken but it has not affected the bumper. The infant's face is against the bumper. Now for the next series of cases, I'm going to talk about where the staff disagreed with the medical examiner. So slide eight. This is the baby face against bumper. You can see the crib has lots of things in it. There's an empty space where the baby was found. The autopsy, very specific. Infant found in a corner of the crib covered by a pad that would cause asphyxiation. The CPSC team said the addressability was unknown. Several concerns, one the baby was sick, had respiratory infection and been on antibiotics for five days. The pediatrician however who was treating him when interviewed said we don't think that the illness was severe enough to cause a death. The second concern was this is a seven month old and should be developmentally able to move its head but the baby didn't. Here is a case of wedging with a bumper and you can see the indentation in the bumper pad. This is slide nine. Again a very specific autopsy finding. Infant became wedged between the mattress and the bumper pad of the crib. CPSC team thought this was unlikely to be addressable. And the reasoning was you can't tell, they could not tell if the face was truly into the bumper or into the place where the bumper and the mattress intersect. They also saw a blanching levidity that to them meant the baby was faced down on the mattress and so they considered the bumper incidental to the death. Again, disagreeing with the medical examiner. This is a case, you see a positioner in the crib and to the right there's an empty space where the baby rolled over into the mattress. This was the cerebral palsy child. And, but again the autopsy was very clear, fixia due to obstruction of the nose and mouth by the crib bumper. Here the staff misidentified a picture as a recreation. The father recreated the death scene but there was no photograph. I called the medical examiner asked if they had a recreation photograph and she said no they hadn't taken one. Here's a picture where you see, whoops where am I, slide 11 I believe. You see a finger pointing to where the infant was found. The police officer is doing the pointing. The autopsy probable as fixia due to obstruction of the nose and mouth. Found unresponsive wedged between bumper, the crib and the mattress. Again, CPSC team disagreed said it was unknown if it was addressable and the reasoning I could find was limited in conflicting information in the case report. Slide 12, this is a stuffed animal, bunny rabbit who was used to recreate the death scene and again you see a crib with lots of stuff in it. The autopsy said A, infant reportedly found face down with face wedged between mattress and bumper pads of the crib and then said an interesting thing, suffocation in nonstandard sleeping environment. So I called the ME and asked what exactly did that mean and she said we think a standard sleeping environment is a crib with mattress and a sheet. Slide 13, baby rolled out of positioner face against the bumper. Beth is very specific, the autopsy once again, face wedged between crib bumper and mattress. The CPSC team thought the addressability was unknown and said it was not specified whether the baby's face was against the comforter or against the crib bumper. I just have a couple more of these, slide 14. Well, you see the wedging and the autopsy said this is an alfixia face between pillow and crib bumper. The CPSC team said they were not sure whether the nose and mouth was pressed into the nursing pillow or bumper. But of course with a wedging that doesn't matter. Wedging is two surfaces, you take one away and the wedging doesn't occur. And my last case is a sudden infant death case that we thought was likely a suffocation. This was 1992, death scenes were not prevalent. And CPSC was doing a soft bedding study at that time. I was the team lead and CPSC's investigators were going into the homes quickly after the baby died interviewing the parents, asking them to place a doll. This is actually a CPSC photo. The medical examiner did the autopsy the day after the baby died, was not aware of CPSC's results or the picture and so classified this as a SIDS. So my conclusions are these cases illustrate that crib bumpers can cause deaths and there's many more of them than the CPSC staff identified. The CPSC team often disagrees with the medical examiners and pathologists. That's not highlighted anywhere in the briefing package. There's an occasional mention of what the ME said, but there's no, the reader doesn't understand the extent to which the team disagrees with the medical examiners. Thank you. Thank you very much, Dr. Thatch. Yes, I don't have a designation for the number of the slide. Anyway, this is apparent life-threatening events or ALTIs as it is known associated with crib bumpers. Okay, there were a number of incidents identified from CPSC databases. January, 1992, October, 2012. There were 146 incidences from these. We identified 11 apparent life-threatening events. Okay, the next slide is the baby monitor alarmed, presumably indicating not breathing or perhaps a low heart rate. And mom found the infant face pressed against the bumper. Another case was baby monitor alarmed and a six-month-old female infant was found with head between crib bumper, crib and the crib bumper. The lips were blue and the infant was pale. And they, uh-oh, I'm switched. Hold on. We can hear you, Brad. Coming down on it. This is slide 19 for those who are following along. This is slide 19. The computer keeps cutting out. Okay, so the next case was mom found a bumper. The baby was blue limp and not breathing. Somehow this was called respiratory distress syndrome. But it's clear that the face was against the bumper. Next case is mom found lodged, mom found the infant lodged in a corner under bumper pad with the arms stuck through clib slats, face red from not being able to breathe. And the next case is mom found the infant wedge between bumper pad and mattress. And the diagnosis was transient sinosis, probably secondary to the position I found. Then there were some cases of choking, ingestion, or strangulation, mom found, mom of a mother of a female infant swallowed a piece of, no, the infant swallowed a piece of plastic from the crib bumper. The next case, baby monitor alarmed. Seven-month-old infant found with crib bumper strap obstructing her airway. Next case is a six-month-old infant suffered respiratory, suffered temporary anoxia from suspected strangulation from tie-down straps. Infants stopped breathing, but the infant's cousin rescued her in time. Then we go to problems with infants falling out of the crib. Ten-month-old infant fell from the crib, stepped on the crib bumper, and the diagnosis when they went to the emergency room was closed head injury. A 17-month-old infant, mom thinks baby climbed into the bumper pads and fell out, and the diagnosis in the emergency room was closed head injury. The next one, victim pulled herself up and stepped on crib padding. Crib was at the highest mattress setting, and the diagnosis in the ER was head injury, and the final one is, or did I already do that? Suffered temporary anoxia from suspected strangulation from tie-down straps. Infant, no, I already said that, okay. And here are the falls. It was the last one, Brad. Hello? It's the last one. Can't hear. It's the last one on this slide. Nine-month-old female used her bumper pad as a step, climbed up and leaned over. Yeah, climbed out, leaned over the side of the rail, lost her balance, and fell. Looks like that's it. Yes, I'd like to say, we said 11 alties, I found another one, so there's actually 12 that we showed in the slides. The interesting things about this is that when we did an analysis for our paper, the youngest babies were the near suffocations, about five months old on average. The strangulation chokings were about seven to eight months old on average, and the falls were 11 months old on average. There are no alties for limb entrapments or miscellaneous. Dr. Thatcher, Dr. Shears, I do have a question. When we're looking at these, what you could call near misses, is there anything that would distinguish them from the fatalities other than fortuity and luck? Is did you see any pattern that would explain why there was no fatality other than somebody came in and found the child or pure luck? I think most cases, someone came in and found the child. It was in most of the cases. I don't know what you mean by pure luck. Well, that would be pure luck, that somebody walked in before the child aspired and saw the child and saved the child's life, but otherwise that child would have become a fatality. Right, that's the case as I see it. Thank you very much. Ms. Covington, and welcome. Well, they're working on the slides. I had a question for Dr. Shears and Dr. Thatcher, which is Dr. Shears, in your presentation, you distinguish your conclusions from those of the staff, and I was just curious on the alties. I just couldn't remember. I'm sorry, there are no staff determinations on the alties. Okay, thank you. As they get going on this, I'll start talking. I was asked to present on data that we have in the National Child Death Review Case Reporting System, which I'll explain a little bit what that is, and they're considered non-CFPSC cases. We had worked with Dr. Shears a couple years ago to try to match the cases that we had in our database with the cases that CPSC had, and I think you identified two or three that were they actually were the same case. So in the case, in the cases that I'll present on that came after November 2013, are new cases that weren't known. I'll skip through some of these slides real quick. I just wanted to mention what Child Death Review is, so you have a perspective on where these cases come from. Child Death Review is a multi-disciplinary case review that usually happens in communities across the country, where people come together and review the deaths of child, of preventable child deaths. And the team typically brings a whole lot of information to the review, they'll have coroner reports, medical examiner reports, death scene investigation reports, law enforcement, interviews, and medical records, et cetera, et cetera. And they talk about the case, and the purpose of Child Death Review is really to identify risk factors in areas where a community could prevent deaths. In the United States, we have Child Death Review in all 50 states, 37 have local teams, and then 12 states have only state-level teams. We also, and I should say that our center is funded by HRSA primarily, although the CDC also funds a sudden and unexpected infant death case registry, which funds a good number of states to review 100% of all of their sudden and unexpected deaths, which has given us a little bit more robust data into the system. In 2005, we designed a case reporting system so that teams could enter their data into a database. And we built the system that allows data to be collected and are analyzed and aggregated across local, state, and at the national level. So we now have access to the real rich case information that comes from the teams. It's a web-based system. There's about 1,200 data elements, and it's housed at the Michigan Public Health Institute. So I'm gonna skip to here. Just so you get a sense of the system, there's 45 states that voluntarily use it now. We've got about 2,000 users, about 1,300 teams, and we have about 167,000 deaths now in the database. But the system has gone through a number of permutations. I think we're at version 4.1 right now, and I'll explain to you why that's important in terms of trying to understand the bumper pad cases. The limitations are, is that except in a few states that review 100% of all of their sudden unexpected infant deaths, the data can't be used as population data and you can't calculate rates. And that little sentence, both to me, there may be cases with a good amount of missing or incomplete information. It's a voluntary system, and it's up to the states to put in what they can. Also, child death review standards vary across jurisdictions as to the quality of scene investigations and case reviews. And then there are times where teams may classify as a death differently than the coroner or medical examiner would, but it allows, there's a place in the report from where you can actually designate that that happened. We have a number of questions related to sleep-related deaths. I'm just gonna show you these are just so you can see what the forms look like in this by the way. I'm so, we're so bad at numbering our slides. This is slide eight. So there's a whole section on the form that regardless of whether a death comes in as a suffocation of SIDS or undetermined, those are the main suede categories. A team can go to this section that says was the death related to sleeping or the sleep environment for children under the age of five. And then it allows the team, there's a whole lot of questions about where was the sleep place? Were they sleeping alone? What was in the crib, et cetera, et cetera, or the sleep place? Were they overheated? Was the face, where was the child's face when found? Where was the neck when found? Was the airway obstructed, et cetera, et cetera. The two most important things that are for my presentation is that we changed the form in late November of 2013. Before that, what we realized is that we couldn't narrow it down to what was really the main factor causing the problem in the sleep environment. So prior to 2013, we asked questions such as was the face fully obstructed or partially obstructed? How, between wedged into pressed into, et cetera? And with what objects? And teams could check all of those boxes. So it was really difficult in looking at our analysis because we have a number of cases where bumper pads were listed within a lot of other things, but we were having a hard time identifying what was really the most problem in the sleep environment. After 2013, we changed it so that a team could say bumper pad, present, yes or no. Where was it on top of under, next to, or tangled around the child or unknown? And if present, did it obstruct the airway? So the data, I have seven cases from teams from 2014 and that's pretty much what we've got in the database right now. It takes about a year for the teams to get this information in. We've got seven cases where it was the bumper pad that was listed solely as the item that obstructed the airway. So just to give you the data, we downloaded data for this presentation or actually for some work we were doing a little while ago and the data that we're looking at is not 167, it's only 95,000 deaths because the teams have to tell us, the states tell us when the data is clean and ready to be used for national analysis. There were 16,140 suede cases in there. 87 of those were checked under that sleep related item. 62 cases where the bumper pad was checked as relevant to the death. And 55 of those were they checked in that piece that I talked about before 2013 and then seven cases where they listed at a specific club specifically causing the obstruction. So I wanted to also say that the good news is that all 62 of those, there's also a place in the form where teens can mark whether or not there was a death scene investigation and who conducted it. And we were really happy to find out that all 62 of those had had a death scene investigation. And this is, NJ had, Dr. Shears had shown some pictures but this is what we're hoping typically you would have in a death scene investigation would be a description of where the child was found, placed and where it was found. Just so you can see, these are the agencies that had conducted the death scene investigations which we were pleased with and they're not mutually exclusive. But there were, in our opinion, probably quality death scene investigations conducted in these cases. So in looking at the data that was collected through November 2013, we had 55 cases where the bumper pad at least was checked as an object relevant to the death. And then we had the seven where they actually checked the bumper pad and that it was present and it obstructed the airway. Of the, out of all the 62 cases, what we did then is the teams write narratives and every one of these cases had a written narrative. I think there was one that did not and it's the narrative where we can find most of the rich information. The teams tend to write really long narratives. They talk about a lot of things. They talk about the family, the condition of the house, the family's socioeconomic status. Oftentimes they talk about whether drugs are alcohol or present, et cetera, et cetera. There's a lot of information in the narratives. So we pulled the narratives and we found 30 out of the 62 where it was specifically stated that the child was found pressed into the bumper. And the cause of death over those 30, and I don't have the percentages here, I'm sorry, was external asphyxia, undetermined, medical condition SIDS, which is interesting because that's a very small percentage of these, and then undetermined if it was actually a medical or external injury. But more than half were listed as asphyxias. When we looked at the narratives, there were only 13 states that we got this data from. So at the time, I should mention, we've brought states into this progressively over the years. The early years when we first opened the system up to states in about 2008, we had very few states using the system. It's gone, states have started entering the data more and more over the last few years. So 13 states were reporting cases and most of those reported one or two cases, but we had several large population states that had five to seven of the cases. 27 of the cases, the child was under the age of one and there were three where the child aged ages one to four. More than 90% were sleeping in cribs and more than 90% were in their own homes. I just wanted to give you a sense of some. I went last night and I could have given you the narratives on all 30, but I thought we really don't have time for that. But I wanted to get you a sense of what we read in the narrative because it's pretty explicit what they're writing. The decedent was laid to sleep on his right side in a crib, used to roll up blankets for bumper pads and found unresponsive with his head wedged against these bumper pads. Another is that the decedent is a six-month-old male who died due to positional asphyxia. He was found unresponsive in his crib with his face pressed into the bumper. Decedent was placed face up in his crib, covered by light bedding, and found face up in his crib with the bumper pad fully covering his face. This was according to ME, but not documented by anyone else. The child was found on her side with face against crib rail in bumper pad. Another was that at approximately 4 a.m., the father found the deceased unresponsive lying prone in a crib with its face next to the bumper pads at the edge of the crib. The deceased had apparently been placed in the crib on a pillow, and it appeared it had slid rolled off the pillow onto his stomach with his face placed next to the bumper pads. Baby was fed a bottle, then placed prone in his crib for a nap. Father last saw him alive, went on to check on him and found him lying prone more on his right side with his face up against the crib in bumper pad. Another was simply child found against bumper and crib, and this is a six-month-old white male found unresponsive and lying on his side with face fully prone in bumper pad. Child discovered on tummy with nose pressed into bumper pad on crib. And this one was two-month-old female, originally suspicious of SIDS. Autopsy report revealed that the child was found in the crib corner with face covered by a bumper guard on the other side against the mattress. Positional asphyxia. The coroner ruled that the death was accidental due to positional asphyxia. I guess the side was found close to the bumper guard pad of the crib. And then we had a number. Oh, I'm not ready to talk about these other ones yet, but this was where he'd been placed on his back, was found face down with his face pressed against the bumper pad in the corner of the crib. He had just begun to roll over recently. And then finally, the mother awoke to check on the baby and found him in prone position, completely covered by the blanket with his face pressed into the bumper pads in the crib. And then we had a number where it wasn't, there were pillows mentioned as well. That seemed to be somewhat common. And I meant to count out how many had pillows as well as bumper pads, but what we often saw, almost all we saw is that they were placed on a pillow, they rolled off the pillow and they rolled into the bumper pads. So there's sort of a couple of demons in this story. This was the 19-day-old black female the mother put her head propped face up on top of an adult pillow. After checking, she was found wedged between the pillow and the baby bumpers. This two-month-old and 12-day-old black female died of asphyxia. It was reported that she was found face down in a crib with her face buried in the space between a pillow and the bumper pads. And then the mother was placed baby supine on mattress with head resting on an adult pillow. She saw the baby and about four hours later, the baby was prone and wedged between the adult pillow and the bumpers of the crib. So these are pretty much similar to the examples that Dr. Shears had given you, but they're different examples. I just wanted to make the point that they're not the same cases. And then this is another example. The child placed on his back on a boppy pillow, found six hours later on his side with his face in the pillow and wedged between the pillow and bumper pads. And then another who was placed asleep in a crib on an adult-sized pillow and or a wedge pillow. The child was placed asleep on his side and found in the morning with his face pressed into the bumper pad. And those are my examples for you. And that's pretty much what I have to present. So I guess my first question is, you've given us the narrative on some of the cases. May we get your copies of the narratives for all of these 30 cases? Yes, we can. That would be terrific. Absolutely. I didn't think you'd want to hear them all during this 15 minute presentation. Actually, I would. But at least enough to have it so we can put it in the record and we thank you very much. Dr. Moon and Ms. Gidea. By the way, we're running ahead of schedule so there's no need to speak fast. I think most of the people in the room listen fast but there's no need. So again, for those of us on the table, if we have questions or comments, I invite them. I've confused everybody because I don't have any slides. Good morning, Commissioner Adler and CPSC staff. My name is Dr. Rachel Moon and I'm the division chief of general pediatrics and a professor of pediatrics at the University of Virginia School of Medicine. I've spent over 20 years studying infant mortality, safe and unsafe sleep products and sudden unexplained infant death. I have done occasional work for the CPSC as a paid outside consultant on consumer products designed for infant use since 2012. And I very much appreciate Commissioner Adler's invitation to speak to you all today regarding the September CPSC staff briefing package on crib bumpers. I'm speaking here today on behalf of the American Academy of Pediatrics or the AAP and I'm the chair of the AAP's task force on sudden infant death syndrome. Just two days ago, on October 24th, the AAP task force on sudden infant death syndrome released our updated recommendations for safe infant sleeping environment. These updated recommendations reiterate unequivocally that bumper pads are not recommended by the AAP. Bumper pads have been implicated in deaths attributable to suffocation, entrapment and strangulation. And with new safety standards for crib slats are not necessary for safety against head entrapment. While the peak age range for SIDS accidental suffocation and strangulation deaths and ill-defined deaths is between the ages of one and four months, new evidence shows that soft bedding continues to pose hazards to infants who are four months and older and is indeed the predominant risk factor for this age group. Educational and intervention campaigns are often effective in altering practice and pediatricians continue to engage in such educational campaigns. However, pediatricians' warnings against crib bumpers are frustrated when the CPSC's own messaging on crib bumpers is muddled at best. The AAP warns against the use of many different kinds of soft bedding, largely because of the risk of suffocation, entrapment and strangulation. CPSC data show that pillows are associated with many accidental suffocation incidents when placed under or close to a sleeping 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. With regards to bumper pads, I'd like to share the AAP position as stated in Monday's policy statement and technical report. The data show that bumper pads and similar products attaching to crib slats or sides are frequently used with the thought of protecting infants from injury. And indeed, bumper pads were initially developed to prevent head entrapment between crib slats. However, newer crib standards requiring crib slats spacing to be less than two and three-eighths inches have obviated the need for crib bumpers. In addition, infant deaths have occurred because of bumper pads. You've already heard from Dr. Shears and Dr. Thatch and Ms. Covington about their research. Dr. Shears and Dr. Thatch's case series, using 1985 to 2005 CPSC data, found that the deaths attributed to bumper pads occurred as a result of three different mechanisms. Suffocation against soft pillow-like bumper pads, entrapment between the mattress crib and the firm bumper pads, and then 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 the presence of pillows and or blankets that may have contributed to many of the deaths in the report. The white paper pointed out that available data from the scene investigations, autopsies, law enforcement records, and death certificates often lacked sufficiently detailed information to conclude how or whether bumper pads contributed to the deaths. Three more recent analyses of CPSC data have also come to this conclusion. The two most recent ones 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 re-analysis of CPSC databases which was published earlier this year found that the rate of bumper pad related deaths has increased. Although they recognize that changes in reporting may recount for at least part of the increase, they also concluded that 67% or two thirds of the deaths could have been prevented if the bumper pads had not been present. Other researchers have concluded that the use of bumper pads only prevents minor injuries and that the potential benefits for preventing minor injury with bumper pad use are far outweighed by the risk of serious injury such as suffocation or strangulation. Additionally, most bumper pads obscure infant and parent visibility which may increase parental anxiety. There are other products such as mesh crib liners and crib slat covers that attach to crib sides or crib slats and claim to protect infants from injury. However, there are no published data that support these claims. Pediatricians were fond of saying absence of evidence is not evidence of absence. And without published or peer reviewed data, they demonstrate that these other products that attach to crib sides or crib slats such as the mesh crib liners or crib slat covers do not pose a potential for suffocation and trapment or strangulation, these products cannot claim to be safer alternatives to crib bumpers and the AAP does not recommend their use. We urge CPSC to look to peer reviewed data in making these and other safe sleep assessments. Although nearly 100% of parents are aware the baby should sleep on their back, fewer than 50% are aware the baby should not sleep with soft bedding. And we believe that this is largely because of the confusing messages that parents receive. They see advertisement after advertisement for bedding, including crib bumpers and thus 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 deadly. We believe that when crib bumpers, when used solely for the use of infant younger than six months of age are allowed to be sold, this confuses the safe sleep message for parents. I cannot tell you how many times I've heard it from a parent the belief that if they sell it, it must be safe. A surprising number of parents believe that there's an agency out there that tests all infant products before they go on the market to make sure that they're safe. In other words, an FDA for infant products. Unfortunately, as we all know, there is no such agency. And we understand that 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. With regards to reasons that parents use crib bumpers and the misconceptions they're in, our qualitative research with mothers of infants found that the primary reasons for purchasing crib bumpers are that one, they're cute, and two, because parents believe that crib bumpers will prevent serious injury largely from head trauma and limb entrapments. With regards to head trauma, I'd like to apologize ahead of time, I'm a little bit of a science geek, which is why I'm here. And so I'm gonna take everybody back to high school physics where we learn the formula F equals MA, or force equals mass times acceleration. So the force needed to incur major head trauma, which I consider a concussion or worse, requires either a large mass or a large acceleration or both. So the 50th percentile for weight, which is what on earth we use to represent mass, for a six-month old is 6.5 kilograms or approximately 14 pounds. The reason I'm using the example of a six-month old is that's what the manufacturers have said is the age limit for the crib bumpers. So one estimate of the force required to sustain a concussion is 95 G forces. Or if you use physics units in Newtons, which is the universal force, it's 931 Newtons. I know I'm getting in the weeds here. If one assumes that this estimate is true, then for a 6.5 kilogram baby to generate enough force to sustain a concussion, he or she would need to accelerate at the rate of 103 meters per second squared, okay? I think you said 143 in your paper. 143, yes. To give you a point of reference, a car that goes from zero to 60 miles per hour in three seconds has an acceleration of nine meters per second squared. So in other words, an infant, in order to seriously injure their head against a crib, has to get a serious running start. And you would need more than the crib distance to get that running start. So the second concern that parents have is limb entrapment. The majority of these entrapments are reported after the age of six months, which has passed the age limit for crib bumper use. Therefore, if the product is used according to manufacturer instructions, then the product should not even be in the crib with these infants, and therefore would not prevent limb entrapment. Even if we consider a crib bumper use after the age of six months, I think that all of us would agree that although they cause momentary distress on both the part of the parent and the infant and the caregiver, this is a fairly benign condition compared to infant death. We therefore respectfully disagree with and are admittedly perplexed by CPSC staff finding that the risks of bumpers do not outweigh the benefits. We believe the benefits to be non-existence, particularly if the bumpers are used as the manufacturers attend, and the risk to be substantial. We also believe that it doesn't make sense for the CPSC staff to say that there is insufficient evidence of support that bumper pads were primarily responsible for infant deaths when the bumper pads were used per manufacturer instructions and in the absence of other unsafe sleep risk factors. And then use prevention of infant limb entrapment by using bumper pads against manufacturer instructions as a reason to not recommend action on bumper pads. The CPSC's own website states that 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 has families from products that pose a fire, electrical, chemical, or mechanical hazard. A ban on crib bumpers unequivocally meets the standard admission. Crib bumpers are associated with deaths and they pose a mechanical hazard to infants. But rather than recommending a ban on bumpers, the September staff briefing package seems 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 and this is not how pediatricians look at safe sleep. On the contrary, when determining the safety of a sleep environment, we look at the totality of the circumstances. We ask if anyone in the family smokes if the baby is breastfeeding a formula feeding and whether the baby, the family is bed sharing. We understand that elimination 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 soft bedding as other population groups besides infants use soft bedding. However, crib bumpers are supposed to be used only by infants younger than six months of age. Therefore, we believe that the 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 currently being used by consumers, whether in cribs with infants with colds, with other soft bedding or with sleep positioners are involved in one infant death after another, the way to protect the public is to just allow their use not to contort reasoning to permit the use of crib bumpers. The staff package clearly states that soft bedding is a suffocation hazard 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 soft bedding because staff say that bumpers ostensibly serve the purpose of protecting infants from crib, from limb entrapment. This is logically inconsistent, confusing to consumers and deadly for infants. A ban on crib bumpers would reinforce the message that no soft bedding of any kind should be placed inside a baby's crib. There's one surefire way to prevent infant death from crib bumpers, don't use them ever. The AP reiterates its request to the commission to ban crib bumpers, thank you. Thank you very much. Just a couple of quick reactions to what you said. First of all, with respect to education campaigns, I think the commission follows the philosophy that was enunciated by a chairman at a recent conference on information and education which is there's a hierarchy of public health approaches and the first approach is always to try to design out the problem, because as I keep saying, it's easier to redesign products than it is to redesign consumers. And if a redesign won't work, if it's impossible for a variety of reasons, then you try to guard against a hazard. You put some kind of protective barrier between the hazard and the consumer. And then the third one, if you can't find a way to approach it either through redesign or through guards is to use education. So we certainly understand education has its place, but I for one am skeptical that education would ever be a be-all and end-all. It's part of a totality of approaches and I appreciate your remarks there. I'm also, I just can't resist making, being amused by your statement that newer crib standards on slat width, because when I first came to the commission back in Ott 72, we had that two and three eighths of a slat width requirements. So that just makes me feel a little bit younger to hear that you're calling it one of the newest standards. Well, anything I can do to make all of us feel younger is the problem. I do, I still remember when I was talking to one of the staff experts which showed my complete knife tale about human factors because I'm a lawyer and I said, what's the problem? The kid can't stick its head through even wider slats. So why not have wider slats? And so with this very patient response, I said the problem isn't that the kid's sticking its head through the slats. The problem is the head won't go through the slats, but the body will. And that's where you were getting the deaths. And the reason I mentioned that is it's not intuitive. Looking at a crib, you would never imagine that that's how death would occur to infants and so that's why it's so important to have scientists like folks here and technical experts who actually look at the dating can make expert judgments and who actually understand physics. I will make one last observation. You're absolutely right that we are not like the Food and Drug Administration. We don't require pre-market approval of children's products. Although survey after survey shows that most people think we do, but we don't. I will say, and again I'm gonna give some congratulations to folks in the room, but in particular Nancy Coles who was one of the moving spirits behind the requirement for third-party testing for children's products. And that is a compromise between the FDA pre-market approval and what the commission operated before in the mode you said which was reactive. So we think that is a big step forward and we have somebody here to thank for that. So I thank you very much for your remarks and Ms. Gidea, do you have anything to add to Dr. Moon's? No, nothing to add informal comments. I'm just happy to participate in the discussion later on. Okay, any other comments? Thank you so much for your remarks. We really appreciate it. And I think we have reached the point where we are going to have a break. I'm sorry. Just one quick question. You mentioned additional recent analyses. Are these the articles that were handed out that you were referencing or is there something on that? So what was handed out are the recent, the policy statement in the technical report that were just released on, published on Monday. Okay, and then the recent analyses that you were referring to in your remarks on page four. Was that the pediatrics article from earlier this year? The recent analyses, so the more recent analyses were the staff briefing package and then Dr. Shears and Dr. Thatcher's 2016 paper. Thank you very much. We are at a point of taking a break. And as I say, we are running ahead, which is not a bad thing. So why don't we take a 20 minute break? Okay. So back at 10 o'clock. Well, one of the things we're doing is waiting for Dr. Sharfstein. So I want to make sure we get the timing right to get him here so that he arrives here and doesn't leave too quickly. So if we have to convene more quickly to accommodate him, we will.