 So good morning everyone and welcome to this public meeting of the United States Consumer Product Safety Commission. This morning CPSC staff will briefly commission on a draft final rule to establish a consumer product safety standard for infant sleep products. This draft rule arises under section 104 of the Consumer Product Safety Improvement Act. Also known as the Danny Kaiser Child Product Safety Notification Act, or Danny's law in shorthand to most of us. This act honors Danny as a child who died in an infant product that had been the subject of two recalls, but the product somehow remained on the market. Danny's name reminds us how precious life is and how dedicated we must be to safeguard it to the greatest extent possible. To put to section 104, the infant sleep products draft rule will incorporate by reference the voluntary standard ASTM 118-17A as a mandatory standard with modifications to make the standard more stringent to further reduce the risk of injury associated with flat and inclined sleep products. The draft rule does two other things. First, it amends the commission's regulation regarding third party conformity assessment bodies to include the infant sleep products standard in the list of notices of requirements issued by the commission. And that's something we do every time we issue a new standard. And second, it requires manufacturers of infant sleep products to provide consumers with prepaid registration forms to be kept on file by the manufacturers. Getting to this point has presented staff with a number of challenges, which I know they're going to describe as new data have regarding the hazards of infant sleep products. Eventually leading to the abandonment of a narrow standard just for inclined sleep products and the expansion of the standard to include all infant sleep products, including inclined and flat products. So the draft final rule now defines infant sleep products as those marketed or intended to provide sleeping accommodations for an infant up to five months of age that are not already subject to one of five existing CPSC sleep standards. And let me note something in the past several days, I and I'm sure my fellow commissioners have received a number of emails from concerned members of the public regarding our consideration of this rule. I want to remind everyone that the official comment period for submitting comments closed some time ago, but it's long been the practice of the agency to dock it, even last minute submissions. Although staff can't comment on them formally the way they do, but we filed comments, but they have been made part of the record. Today's session will proceed as follows. Staff will brief the commission on the draft final rule. After that, each commissioner will have five minutes to ask questions of staff with multiple rounds, if necessary. The following staff members will brief the commission and I say good morning to both of them. Project manager infant sleep products from the division of human factors in the directorate of engineering sciences and Mary House attorney in the regulatory division of the office of general counsel. Also in attendance are Mary Boyle CPSC executive director, Jen Sultan acting general counsel and Alberta Mills CPSC secretary. One final moment point before I turn the meeting over to staff, because this is a public meeting and because staff legal advice should be provided in a confidential setting. I'm going to ask that any any questions that address the agency's legal authority or legal justification for this rulemaking be withheld to a more appropriate moment and setting. So thank you everybody welcome I now turn the gavel over I believe to Celestine, and we look forward to your brief. Good morning, actually I'm going to speak first. Good morning. That's okay. And commissioners good morning. Again my name is Mary House I'm an attorney in the office of the general counsel, and Celestine kish is here she's the project manager she's a senior engineering psychologist and the division of human factors. We've already stated we're here this morning to brief the commission on the draft final rule to establish a safety standard for infant sleep products. Next, the commission can issue the draft final rule pursuant to its authority under section 104 of the consumer product Safety Improvement Act of 2008. Which is also known as CPSIA section 104 requires the commission to issue safety standards for durable infant or toddler products. Section 104 F defines what a durable infant or toddler product is. It's a durable product intended for use, or that may be reasonably expected to be used by children under the age of five years. The statute includes a list of durable infant or toddler product categories, and the commission can add categories to this list. The list already includes infant sleep products such as cribs play yards and bassinets and cradles. Section 104 also requires that in consultation with consumer groups, product manufacturers and independent child product engineers and experts. The commission examine and assess the effectiveness of any voluntary standards for durable infant or toddler products. Next, the commission must promulgate consumer product safety standards that are substantially the same as the voluntary standard, or more stringent than the voluntary standard. The commission determines that more stringent standards would further reduce the risk of injury associated with the product. Additionally, the commission can adopt voluntary standards either in whole or in part pursuant to section 104B4. Finally, under section 104B2, the commission must also periodically review and revise the standards issued under section 104 to ensure that such standards provide the highest level of safety for such products that is feasible. Now I'm going to hand off to Celestine to discuss the staff's recommended draft final rule for infant sleep products. Thank you, Mary, and good morning. I'll start with some background information about this project. Staff began working with ASTM on the development of the voluntary standard for infant and kind sleep products in about 2011. And that was as a result of hammocks and other inclined products not being included in the BassNet and Cradle standard. In 2015, ASTM published the first version of the F3118, which is the standard consumer safety specification of infant inclined sleep products. Then the commission published the notice of proposed rulemaking in April of 2017 that referenced ASTM F3118-17 with one modification to the definition of accessory. ASTM agreed with the modification and published in October of 2017 published F3118-17A, which is the standard we will be referring to throughout this presentation. Next. Now between the two years between the NPR and the SNPR, staff identified additional fatalities associated with rocker-like inclined sleep products. And the commission issued safety alerts and recalls involving infant inclined sleep products. In addition, compliance staff contracted with Dr. Erin Mannen, a PhD in mechanical engineering with a biomechanic specialization. And she conducted testing to evaluate the design of inclined sleep products. Mannen's study concluded that infants in products with seatback angles greater than 20 degrees exhibited increased demand on their abdominal muscles. This could lead to increased fatigue and suffocation if an infant is unable to reposition themselves after an accidental role from supine to prone. The Mannen's study concluded that a sleep surface that is 10 degrees or less is compatible to a crib mattress surface and can be considered a safe sleep surface. Next. Staff submitted the draft SNPR package to the commission and posted it on CPSC's website in October of 2019, October 16, 2019. The following week, ASTM held their bi-annual F-15 juvenile product subcommittee meetings. And therefore, staff was able to discuss the package within multiple subcommittees including inclined sleep products, bassinets, and infant sleepers. The SNPR references ASTM F-3118-17A with significant modifications. Next. Here's a quick overview of the draft final rule that is substantially the same as the SNPR with clarifications in response to comments. Infant sleep products are defined as products marketed or intended to provide a sleeping accommodation for an infant up to five months of age and that are not covered by a CPSC sleep standard. This applies to flat and inclined products and manufacturers must test their products to confirm that the seat back and sleep surface angle is 10 degrees or less from horizontal. They also must meet the bassinet cradle mandatory standard. Next. When we talk about the CPSC sleep standards, we're talking about these five regulations, bassinet and cradle, the full-size baby cribs, non-full-size baby cribs, play yards, and bedside sleepers. So if a product intended for infant sleep already conforms to one of these sleep standards, that product is not within the scope of this draft final rule. Next. And now we have some show and tell. These are examples of products that are in the scope of F-3118-17A, the voluntary standard for infant inclined sleep products. Typically, these are identified as hammocks, nappers, play yard accessories, and inclined sleepers. Next. These are products staff considers in scope of the draft final rule. They do not meet any of the five CPSC sleep standards and yet are marketed or intended for infant sleep. They are typically identified as in bed sleepers, travel bassinets, compact bassinets, infant tents, baby boxes, and crib accessories. CPSC staff considers these items marketed for napping, snoozing, dreaming, or any other word that implies sleeping, or that is called a bed, and items marketed with pictures of a sleeping infant to be an infant sleep product. There aren't any infant sleep voluntary or mandatory standards for which these products have to meet at this time. Next. In the draft final rule, staff responded to comments received from the 2017 NPR and the 2019 SMPR. Numerous comments on the 2019 SMPR, such as the American Academy of Pediatrics, consumer groups, individual parents, express support for the SMPR. And this is because products covered in the draft final rule will be required to follow the AAP safe sleep guidelines. As you can see in this list, other commenters raised questions about the topics such as the scope and definition to clarify which products will be covered in the final rule. They ask about the incident data and how safe sleep principles such as bed sharing are addressed in the final rule. Over the next few slides, I will explain how staff address the comments and how the draft final rule clarifies the SMPR. Next. First, I'll start with the data and hazard patterns. In the 2019 SMPR, staff identified 59 fatalities and 96 non-fatal injuries related to infant inclined sleep products. In this draft final rule, staff identified 10 additional fatalities and 17 non-fatal injuries. The hazard patterns are generally the same and I'll get to that in a minute. Next. In response to the SMPR comments, staff identified 183 incidents and 11 fatalities associated with the use of unregulated flat sleep products, meaning those flat products marketed for infant sleep that are not currently subject to an existing CPSC sleep standard or voluntary stamp. There are also 16 non-fatal injuries. Next. In the 2019 SMPR, staff identified hazard patterns and although the data distribution in the draft final rule varies somewhat from the SMPR, staff finds that the broader hazard categories are very similar to the hazard categories previously identified. As you can see, the hazard categories are listed in descending order of frequency, which is not always the same as the level of severity. You may not think of consumer comments as a hazard pattern. However, after the SMPR was published, we received reports consisting of consumer comments and observations of perceived safety hazards. There were complaints that the sale of recalled infant inclined sleep products or there were inquiries about the April 2019 safety recalls of these products. Within the category of design, we identified 10 incidents that reported that infants rolled over fully or partially from their original supine position. The reports describe infants as young as one month of age rolling over. Parents and caregivers who witnessed and reported some of the non-fatal incidents were able to rescue a distressed infant quickly. However, other infants died due to suffocation or asphyxiation. Eight incidents reported that infants develop physical deformations such as flat head syndrome or torticulus from extended product use. And five incidents reported that infants develop respiratory ailments due to growth of mold on their products. The other product related category includes incidents related to instability. You know, products that were not completely or products that completely or nearly flipped over or locking and latching problems where the sleep surface failed to remain in position. One of the three instability incidents was a fatality that occurred when a foam type recline seat tipped over and fell from the adult bed with trapping the infant underneath on the floor. The structural integrity category deals with reports of components breaking such as rails or hardware or other unspecified parts. The electrical category only had one complaint and that was related to an overheating incident. Now the non-product related an infant was placed supine in a rocking inclined sleep product with a blanket over his face and then was found deceased in that same position. Unfortunately, staff has no information on the circumstances for the five deaths in this last category. There were also two reported injuries that simply described a fall but no other information was provided. Next, similar to the infant inclined sleep products, the hazard patterns reported for unregulated flat infant sleep products varied according to the type and usage pattern of the product. As you can see, these are presented in descending order of frequency, but again that doesn't necessarily relate to hazard. So first we have a lock and latch. Reports in this category primarily related to the locking and latching mechanisms that controls the opening and closing of a cover on a specific product. Some reports describe that the inability of the cover to open completely resulted in, I'm sorry, some reports describe that the inability of the cover to open completely resulted in the product not lying flat. And a report for a different product describes a foldable sleeper not remaining flat and in that case the unit actually folded up with the infant inside. None of these reports mentioned any injuries. We have more consumer comments and they're similar to the inclined sleep. They were consumers or safety advocates expressing concern about perceived safety hazards of a product. Non compliance with relevant standards that a product is being labeled as and or misleading marketing statements about a product. 7% of the reported incidents involved falls and containment. Infants falling out of the product or an infant not being kept contained within the product. For example, infants rolling out of a sleeper onto an adult bed and then onto the floor. Another example is an infant falling out of a sleeper when a sibling jumped on the couch where the sleeper was positioned. The one fatality in this category involved infant crawling or rolling it was unwitness we don't know how the infant got out of the sleeper, but ended up being trapped between an adult bed frame and a mattress. Instability like falls and the containment represented 7% of the incidents. The incident reports described some products with legs lifting up higher or leaning to one side and other products having slipped off or flipped over from the adult bed or couch on which they were resting. Asphyxiation suffocation has 8 of the 9 incidents were fatalities due to suffocation or positional asphyxia. The 9th was a near suffocation episode, because a nearby parent rescued the infant. The products were compact bassinets, travel beds, baskets and in bed sleepers. One of it, one of which was being used inside a standard bassinet and another was being used inside a player. All but one of the infants had rolled over from their initial position, either fully or partially. For miscellaneous this category involved incidents related to mold or complaints about the quality of the product materials. And in this last category staff could not definitive definitively identify the issues involved. Two of the incidents were fatalities and in both cases, the CPSC field investigation reports indicated that the cause of death is undetermined. The third incident resulted in hospitalization due to unspecified breathing difficulties suffered by the infant. Next, so now I'll present how the 16 CFR and 1218 bassinet cradle regulation addresses the hazards for inclined and flat sleep products. Dr. Mannan's study concluded that 10 degrees is likely a safe incline for infant sleep. And that supports the 10 degrees sleep surface stated in the scope of the bassinet and cradle standard. Tips, tip overs, falls and contaminants are all very much related. The incident data identified falls and containment incidents when compact portable products were used on an elevated surface such as adult beds and couches. The data also demonstrated that short sides failed to contain the infant. So the bassinet standard will address falls and containment because of two requirements. One, the side height. Bassinet's required that 7.7.5 inch side height and also the stability test. The bassinet standard stability test simulates a two year old male pulling on the side of the product. Incident data confirms that compact portable products are used on raised surfaces from which infants and products may fall. And staff concurs that sibling interaction is a reasonable scenario in which the product may tip over. Although the inclined sleep standard allowed allowed an exemption from this stability test for compact portable products. The bassinet standard does not and therefore requiring all infant sleep products meet the more stringent stability requirement in the bassinet standard will address these issues. The definition of a bassinet in the standard indicates a stand is required. So staff considers this another feature to help to help with stability because of the stringent stability test required. The bassinet standard and the inclined sleep products standard have similar structural integrity testing that the bassinet standard is slightly more stringent. The bassinet regulation has two performance requirements related to locking and latch. One deals with the unintentional folding and the other deals with ensuring removable bassinet beds attach and stay attached to the base stand requirement. Staff concludes these requirements will address the risk of injury associated with lock locking and latching features on these products. The overall performance requirements in the bassinet standard are intended to address known suffocation hazards with infant sleep and create a minimal safe sleep environment. Therefore staff is confident in recommending that all unregulated flat and inclined sleep products meet the bassinet regulation. Next, in the next two slides, I will explain staff's clarifications to the recommended SMPR modifications to ASTM F3118-17A Voluntary Standard. First, throughout the whole standard, staff continues to recommend removing the term incline. In the introduction, staff clarifies that known infant sleep hazards include but are not limited to seatback or sleep surface angles that are greater than 10 degrees from horizontal. The scope clearly states that flat and inclined products are included and that products that are not already subject to any of the five CPSC sleep standards are subject to this. In addition, there's one exemption listed for crib mattresses that meet F2933, the voluntary standard for crib mattresses. And that standard is also added to the reference documents. Next, to ensure all infant sleep products are in scope, staff clarified the definitions by removing freestanding and generally supported by a stationary or locking base. Staff also clarified the definition, clarified that the definition includes products that are marketed or intended to provide sleeping accommodations for an infant up to five months. The broad definition of infant sleep product allows staff to recommend removing the definitions for accessory compact and newborns because they all fall within the infant sleep product definition. The draft final rule only has two performance requirements essentially. One is to measure the maximum seatback sleep surface angle. This is a clarification because the sleep surface, this is a clarification that sleep surface must be measured because flat sleep surfaces do not have a seatback. So we added that clarification. And then complying with 16 CFR 1218 bassinet cradles, including the definition. So it is clear infant sleep products must have a stand to meet the performance and labeling requirements. Next, staff assesses that a significant economic impact is possible for about 12 small importers, nine small domestic manufacturers and hundreds of home based small businesses. The impact is expected for companies that have non compliant infant sleep products as a substantial portion of their product line. The impact depends on the ability of small businesses to either redesign existing products and conduct third party testing to demonstrate compliance or remarket as not intended for infant sleep or remarket for infants older than five months. However, the option to remarket has a caveat. If consumer perceptions of product use, and the physical design demonstrates no other possible use except for sleep, such as with infant hammocks compact bassinets in bed sleepers remarketing may not be an option. To reduce the impact of the draft final rule, staff recommends a 12 month effective date to give impacted manufacturers sufficient time to redesign and test their products and importers time to find compliance suppliers. Next. So to conclude, staff recommends the commission publish the final rule that is consistent with the SNPR adopt F 31 1817 a with substantial modifications to address all unregulated infant sleep products inclined and flat to make the standard more stringent to further reduce the risk of injuries associated with infant sleep products. Staff recommends keeping the effective date at 12 months after publication of the final rule, as just stated to help reduce the potential economic impact on small businesses. Thank you, and staff is now available for questions. Thanks so much, Celestine and Mary, as usual, excellent presentations very, very substantive and a lot of stuff to digest. So I suspect there'll be some questions that are asked and I have a couple of very quick questions that I'll lead with and I remind us that we will have five minutes per round. I'm very flexible about that usually if you've got a train of thought, I will usually let a commissioner follow that and ask all of us to be somewhat self controlling about abusing the time. So I guess one immediate question is when I looked at the slide 14 there's a time frame for set the 71 and I wondered where did that number of 71 come from. Yes, I was, I'm not clear where that was that post SNPR. Let me just check which one slide 14. And it's. Yes, so the 71 incidents were related to a new data poll that is post SNPR was pulled for this draft for the draft final rule. That was really great. I was pretty sure that was it but I just needed to pin that down. You did mention mold as an issue with a number of consumer complaints and I've read that as well but correct me if I'm wrong there's nothing in our standard relating to controlling mold I'm not sure how we would do that is that correct. That is correct. The next question is Dr. Manning study picked 10 degrees as the maximum limit and then you also point out that health Canada sets it at seven degrees in Australia at five degrees. I guess just to put it on the record is there's something they know that we don't or where we follow the science with Dr. Manning. It's actually a multiple thing, multiple issues. We were following Dr. Manning, but also the seven degrees in health Canada was actually in Australia was a side to side angle where Dr. Manning was looking at the head to toe angle. And so we went with the 10 degrees and and again also was already in our bassinet standard was 10 degrees. Yeah, it would always seem to me that the side to side would be taken care of unless that somebody's got bad quality control so I do understand that. I did have a question that may be a little unrelated to what is going on with this specific standard but I did see that staff excluded sleep wedge pillows and sleep positioners from the standard. And I just am wondering, I thought we had some issues with those products and so is it because they don't present a hazard or is it because that if we're going they're going to be addressed it will be addressed outside of the infant sleep products standard. CPSC and FDA have actually both acknowledged the hazards of sleep positioners and have advised consumers not to use them. But they also don't meet the definition as proposed in this final rule for infant sleep product because they're actually used in conjunction with something else. They're not, they're not a sleep product all by themselves. One thing if you recall and I'm sure you do because we were inundated with complaints about setting the angle so that kids who are suffering from acid reflux wouldn't be able to take advantage of the inclined sleepers. And I'm amazed to see that there might still be products that are sold as medical devices to address acid reflux. And I guess the question is, are there really products like that on the market today. Because I can't say that I've heard of them, although I'm not immersed in FDA medical device regulation. There are products out there. I actually don't know if they meet the definition of a medical device. So there are unfortunately still sleep positioners available. But that's the extent of my knowledge on them. Well, that's much more than my knowledge. So at this point, I'm going to stop my questioning. I will have further questions to ask. But now I'm going to turn to Commissioner K to see if he has any questions or comments. Thank you, Mr. Chairman. And thank you to staff, Ms. Kish. I wanted to start, please, Ms. Kish on the age range. And so first to clarification. When staff proposes up to five months, if an infant is five months and a day, does that mean that that is outside the scope? Typically, ASTM standards and our regulations say up to five months. And so to answer your question, I would say it could include children through five months. It could include children up to the very minute they turn five months. It has to do more with their developmental abilities. And so it's within that five month range. I don't think a manufacturer would market their product to say five months and older or five. It's a close five months. But I don't know how else to answer that. Yeah. And the reason I ask is, as you point out, there are other standards, of course, where the upper age limit is delineated. And this has come up, for instance, in the tip-overs context with age five and whether that includes children that are over them five before six. And so I'm just wondering how folks would understand. And it does seem like there's some gray area in there for children who might be between five months and a day and the end of five months. And as you mentioned, marketing doesn't usually, I'm not aware of marketing usually, including that age range. But I'm just wondering if there's a gap between things that might be zero to five and things marketed for six up. So that's, I guess, at this point, more of a comment. In terms of the ASTM process, can you just walk, and you obviously, you guys did a good job of this in the package, but could you walk us through during this briefing, please, a little bit more about how much consultation there was and specifically on both parts of it, both the what we used to call incline products and then also what you're calling flat products? Sure. So even before CPSIA went into effect, staff was working in the ASTM process, developing standards or renewing standards. Once CPSIA went into effect and these 104 rules, then we had to start working towards making them regulations. Staff was very active in the voluntary standards and had been consulting and participating in the actual development of the incline sleep standard because it didn't even exist. Originally before CPSIA, and that came about because, again, they weren't included in the bassinet standard. So staff has been very active in participating in all of these voluntary standards, bassinets, in-bed sleepers, incline sleepers and cribs and all of the five regulations that we talk about. And at what point did flat products become something that you were actively consulting on? So because the bassinet standard was actually trying to create a new section within it for compact bassinets, we were very active. We are and still are very active in the bassinet development and talking about the compact bassinets, which are the flat. And then there was a lot of discussion within ASTM about in-bed sleepers, whether they should be in the bassinet standard as part of the compact group or if they should be their own. And ASTM decided that they were going to try and separate in-bed sleepers into its own standard. And so that's why they're working on, there's a group working to make that regulation. So it's all been coming out of and doing between the bassinet standard. I see. And presumably CPSC staff has been very active in these discussions the whole time and sharing data. Is that accurate? That is accurate, yes. And if it turns out that the commission adopts this rule, is there anything that precludes ASTM from continuing its work and at some point creating its own standards that we might consider for these products? Absolutely, they can do that. Part of the 104, CPSC 104 rule says that we can take a look at these standards and if ASTM presents something that we will review it and consider it for renewing or updating any of the regulations that we have. Got it. Thanks so much. I have no more questions. Thank you, Mr. Chair. Thank you so much. Commissioner Biakko, your questions or comments? Yes, thank you. Going third is going to make me jump around a little bit. So I apologize for that. And I do agree with Bob. There's a lot in here to digest. I know there was a lot of work that went into this package. And candidly, I am struggling with organizing it in my own mind. So some of my questions actually go to that. And just to follow up on something that Bob asked, because I had written the same thing down. So we don't have anything to do with mold. So the incidence dealing with mold, we should take those out of our numbers, right? I mean, we had a couple incidents that we were looking at that dealt with mold, right? So the mold came up because there was one product that had a large number of complaints involving mold, and that company actually recalled their product because of the mold issue. We do still occasionally get comments on it, but we really have not included that in any ASTM or CVSE has not included that in any standard. So to the extent we have the incidents that include mold, we should take them out of our numbers here because I'm trying to sort through the numbers. I have a bunch of questions on the numbers. Let's talk about the pre-market approval that I've seen a couple times throughout here, throughout the package. What can you explain to me why we would recommend pre-market approval and where that authority comes from? Because I'm aware that the FDA has pre-market authority or pre-market approval authority for our medical devices. I'm not aware of any authority like that that applies to the CPSC. Can you help me find that? So we do not have pre-market approval. I'm not sure where you saw that in the package because we have these regulations and manufacturers are required to comply, but we do not provide pre-market approval. But that is one of the recommendations in the package. And I know I'll get a chance to come back around. So I'll find that specifically, but I had written that down a couple times that we were basically abandoning in some regards the rulemaking standards under the ASTM and in favor of a pre-market approval approach. So I was just trying to figure out how we got there. Okay, so I think that may have been in the comments that staff received, that some of the comments suggested that's what we were doing, but that is not how CPSC regulations work. We do not have required pre-approval. We do not provide pre-approval. Okay. I'm going to come back to that because I know I read that somewhere. We relied on Dr. Mannan's study for this analysis. So Dr. Mannan's study helped us with addressing the inclined angle because the initials. Yeah, so Dr. Mannan's study was looking at the inclined angle because the infant inclined sleep standard allowed between 10 and 30 degrees. And so that's what her study was addressing. The other products are already flat, so less, most likely less than 10 degrees. She didn't study, Dr. Mannan didn't study the other products that were sort of, I call it dumping into this particular bassinet standard by this rule. I mean, she didn't study in bed sleepers or you showed us a bunch of pictures. She was really retained, I understand, to do an analysis on the inclined degrees, correct? Correct. She was looking at the inclined. And do you know whether her study has been peer reviewed or it's just Dr. Mannan's study? Dr. Mannan's study, she has published several articles. You know what, I'm going to have to get back to you. I don't know the exact answer, so I don't want to mislead you. So I will get back to you on that. So is there a reason why we didn't hold a forum to talk about and get comments regarding why this rule should include flat infant sleep products? Because I think that under section 104, it says the commission shall consult with representatives of consumer groups, juvenile product manufacturers and independent child product engineers and so forth and so forth. And to talk about a voluntary standard, is there a reason we didn't do that here? Because I know we do a lot of forums. One of the things that I'd like to caution is just going into a line of inquiry that might draw some inappropriate for the public responses. So I just want to caution against that at this time. Okay, but I'm not asking anything that would be inappropriate. I'm asking why we didn't consider or whether we would consider hearing from other groups through a forum. I think we can get back to you on that. I don't. Yeah, I'll get back to you on that. Okay, I'm sure I'm done with my five minutes. So I'll let people move on and try to reorganize here. Thank you. Thank you so much, Commissioner Bianco. I'm going to make a stab at the pre-market approval and I see Mary House is there so she can correct me if I'm wrong. We don't have pre-market approval of products. We don't have the authority to do that. And actually FDA doesn't have the authority to do pre-market approval other than for the class one products under medical devices. I call quasi pre-market approval. When we have one of these 104 regulations, then before companies can market their products, they have to get third party certification. So that was a compromise, if I understand correctly, when they drafted CPSIA between giving us pre-market approval and not having any sort of authority. So what we have is this third party certification. And I look to Attorney Mary House to correct me if I've misstated that. You're good. I don't know about the compromise part, but right. I mean, we, we don't have third party approval. We have the authority to regulate and set performance and labeling requirements for durable infinear topper products. So that's what the rule does. Okay. Now I'm going to turn to Commissioner Feldman. Your questions and comments, please. Thank you. And I want to thank staff for their hard work on this rulemaking. Based on the length of the draft rule, it's clear that an awful lot of work has gone into this project. And the issues that we're discussing here today are important, but they're also complex. Protecting infants, frankly, it's a key reason why we all stood up and raised our hands to serve the American people in this capacity. So it's important that we get this right. I do have several questions. They almost entirely relate to the legal analysis provided in the legal memo dated May 14, 2021. And given that my questions relate to the legal analysis and the conclusions that the Acting General Counsel has reached, I believe that that discussion needs to take place separate from the public discussion that we're having here to preserve confidentiality. So I guess I do have the advantage of going last. Pursuant to the decision-making procedures, I would request that we enter an executive session so that we can discuss the legal issues and analysis that are associated with the final rule. I hadn't been alerted that that was something that you had in mind, but we can certainly have staff consult with you about your legal questions. I'm not sure going into executive session is the appropriate thing to do at this point. This matter involves complex matters of both fact and law as evidenced by the lengthy legal memo that we received. It's 27 pages. The memo raises serious and significant questions and issues that we as a commission should consider as a commission prior to moving forward with the final rule. Having an opportunity to consult with staff is great, but that really makes this then just half a briefing. Well, it makes it half a briefing for you. I'm not sure it is the same for the rest of us. And I certainly believe that you should get your questions answered. I'm not sure that going into this executive session is the way to do that. But let me think about that for a second. But doing it that way and not going into executive session one under the DMPs, if any commissioner wishes to discuss the confidential or legal information related to an agenda item during the public commission, the commissioner shall request to enter the executive briefing session. The commission then shall enter a closed executive briefing session upon such a request. This certainly isn't out of the norm. Well, it actually may be out of the norm, but it may be consistent with the decision making procedures. And as I think about it, I have no problem with going into a brief executive session after we complete the public session. So please muster your questions and you should be able to ask that. Second round if that's what the rest of the commission wants to do. Okay, well, that's fine. I do have some additional questions. I noticed that staff hypothesized that the number of households with newborns at own in bed sleepers could be as high as 25%, which represents about a million units a year. And I, based on the comments, I have no doubt that lots of people bed share but I'm surprised at the large estimate of the people who actually buy and put kids into sleepers. I know these are numbers you're contemplating. They're not numbers we've derived, but I'm curious. Do you really think there are that many in bed sleepers that are sold every year? I am actually going to ask Susan proper, who is our economics representative on the team to answer that question. So we can get her on camera. Okay, yeah, in 10 seconds or less, I don't mean to dwell on that I was curious. Okay, so yeah, that's a pretty good estimate because we came at it three different ways as you'll see in the briefing package. A public commenter said that the unit sold were half a million to 1.5 million, which was consistent with CDC and our own durable products survey on exposure on how many people said that they bed share. Okay, that's really fascinating shows, you know, my son is almost 40 years old and life has moved on and so infant products have. I did want to talk about the bed sharing because I think you saw we got a number of comments from people who feel very, very strongly about bed sharing. And on page 115 in the briefing package, you cite a study from the UK about the reasons why parents bed share. And I thought those were exactly spot on the reasons that friends of mine who bed share who are willing to admit it, why they did that. And so I, I see the benefits of bed sharing, but one of the reasons staff is so cautious about these embed sleepers is because of the hazards. And Celestine, would you mind sort of walking us through what you identified as some of the hazards of bed sharing as opposed to bedside sleepers. Sure, sure. So the data in the briefing package included incidents involving infancy products. And what we found is that there are numerous bed sharing deaths that occur in adult beds. Such as overlaid deaths, soft and loose bedding, suffocation in pillows and adult mattresses or entrapments. So that's this general category of bed sharing. And now they don't all involve in bed sleepers. It's just the whole bed sharing data that we're aware of. And that not all of that data was in the package because we were focused on the products. But we know that these deaths occur. And therefore, you can see in the data in the EpiMemo that these products tip it over and fell out of the bed that they didn't contain the child and child was able to get out of the product and suffocate. And products were rolling over and found in prone positions. So these are these are the hazards that we see in bed sharing with them without an in bed sleeper. Yeah, and just to follow up. It does seem to me that a well constructed, very close bedside sleeper would provide a lot of the same benefits that the in bed sleepers is. If you have any studies, I don't even know what they would say that show the benefits of bedside sleepers. Yeah, I'm not really aware of any studies about bedside sleepers, but that is definitely staff's position that a bedside sleeper gives the infant their own space, but right next to the bed. The baby is no longer between both parents, the baby has own space right next to one parent on the side. And that's certainly the direction that staff recommends for parents who who want to bed share we understand. Clearly we understand that there is a large population of people who want to bed share. And that's why we offer up the bedside sleeper as an option. And basically it makes sense to me that the bedside sleeper would provide a lot of the same benefits. Those are my questions. For the moment, Commissioner Kay follow up questions or comments. Thank you, Mr Chairman. Miss Kish, I just wanted to follow up on one of the exchanges you had with Commissioner Bianco about the consultation. I also read the language in section 104 about the requirement to consult and the various parties with whom we are supposed to consult and required to consult. And then asked why we hadn't done a forum. I just want to clarify that the consultation that has existed factually that's the ASTM process. Meaning the same process we have followed with regard to consultation from the beginning of CPSIA. That's the process that was followed here. Correct. Absolutely. Staff has been very active in the ASTM meetings and development. Thank you. And then on the pre-market approval process, just to make it clear, there's nothing in the package that staff is recommending on pre-market approval. What you're talking about is the response to comments, meaning some of the commenters have viewed this proposal as pre-market approval. And staff is saying that's not accurate. That is the context in which pre-market approval has arisen in this package. Is that right? I believe that is correct. I'm going to look into that and make sure that and provide a full answer to that. But I believe that is correct. We received a comment on that and we answered it. Okay. Thank you, Ms. House. I have nothing else. Thank you, Mr. Chairman. Yeah, just one additional comment on that because I read a study several years ago in which they surveyed consumers and they said, do you believe the government actually requires pre-market approval for children, products and toys in particular? And a huge percentage of the population says, of course the government requires pre-market approval, which shows many as lip-twix the cup and the lip between public expectations and what the commission's actual authority is. Commissioner Bianco, additional questions and comments, please. Yes, please. Thank you. So what I think that is bothering me, and I'm sorry if I didn't articulate it correctly, are better than that. It seems to me that if a group of infant sleep products, if they do not fit within this proposed rule, preemptively we are banning a large group of products. Wouldn't you agree with that? What we are trying to do is require that these products on the market meet a safety standard. And as of right now, there are products that are on the market that do not meet any safety standards. And kind of getting to what Bob was saying, consumers assume that if the product is on the market, it has been tested and is safe. And I understand that, but that's not what we're talking about here and that's not what the rules are. Our rules are, you know, this statute and so forth. And what I'm concerned about is that I think the reason we got so many comments on the bedsharing and bedside and so forth is because the proposed rule was so much further than anybody expected. There was a large reaction. And I think from users, as well as producers, they felt that they were, if this rule went through, they were going to be told, A, they couldn't market their products, B, they were banned. And you see, they couldn't use their products. And I think that that's what I'm struggling with here with this particular presentation. And you had mentioned we've been sharing data, but what data. I mean, when I went here, everything we have is anecdotal, right? I mean, we say that on page 41 that the draft final rule was based on anecdotal data. And I think it also said we don't have any data on in bed sleepers and next to bed sleepers. So I'm having trouble understanding how we went so far from the bassinet standard to swoop in a bunch of things that, A, we don't have any data on and B will if they don't comply with this broad standard, they'll be banned. And we don't have any data that certainly would demonstrate that we have enough information to require a ban on a product. I think that's what I'm struggling with. And if you can help me clear that up that that's that's terrific, but that's the, that's what I keep getting bogged down with. I will try and I may also call in my friend who does with our epi who does all our data but the first thing I want to say is that we absolutely do have data. As you can see from the briefing package, we have 11 deaths in flat unregulated products. We do, we do have the data that shows these products are are hazardous. I love it out of how many. I thought there's 10. So Rosanna, Steve, can you. Can you get Rosanna camera and mic on. I know she can go to the data much faster than I can. Just tell me, you know, because I'm looking on, I think the, I think I'm looking at the inclines but on these on the. On the flat products, there was 11 faith holidays during that period and based on, you know, was I think you said there was one where the child had the blanket over their face. I mean, even if we had 10, I'm not sure that's enough to ban, graphically ban a product. Well, and I would say we're not, we're not banning the products. We're asking, we are telling them how to redesign their products so that it meets these minimal safety standards that we know. As for that are in bassinets. So we know that bassinets meet requirements that have addressed these hazards previously. And so that's why the bassinet standard is what staff is recommending. I understand that but the, the in bed sleepers and the side sleepers, a lot of these products aren't bassinet so to ask them to take their product and redesign it into something that fits into your standard still has the same effect that they can't sell the product as is now they have to change it and get into a different, a different line of business if you will. Well, we are changing it for the safety of the impents. I understand that but not and, you know, but please understand I'm not trying to like beat you up here I'm just trying to understand how we got so far. I was surprised I read the package, how broad it got and I just, I didn't see the breakdown or the support from Dr. I didn't see any of that done with regard to the products that I saw dumped in. And I asked one more question on the bedside sleepers and let somebody else talk but I didn't see anything in here, but I did get a lot of comments from people who were very upset over this proposed rule that would, would stop them from effectively bed sharing and I would think that that would affect a particular socio economic group. And I wondered if we looked at that I mean there are some groups that that would affect more than others, maybe disproportionately and I didn't see that addressed in here I don't know if I missed it. So I just want to make sure I'm, I'm getting your question correctly. The in bed sleepers, which are used by bed sharing families, they, they may or may not be used I mean bed sharing families may choose not to use anything. And just like a AP staff agrees that that is a potentially hazardous scenario. And so what staff is recommending is they use it for the top choice for me is just to say a bedside sleeper, which meets one of our regulations and is very similar to a bassinet actually because it meets the bassinet standard. So in bed sleepers are the concern because the infant, because those products do not meet any regulation. Okay, I think I hope that it doesn't but I'll let somebody else go. I'm trying to come on, if she's still available if she had a quick bit of information she can share that would be fine if not we'll move to Commissioner Feldman. Sure. Yeah, sorry. Go ahead. Good Susan. So the products that are covered in the scope of this rule overlap the prices for compliant products. For example, a bedside sleeper sells for as little as $100 the range of prices for some of the other for the products covered by this rule started about 50 go up to about 200. So there's a lot of overlap in the prices between the products covered by this rule and existing products that are compliant with the existing standards. I understand that too. I'm looking here and I don't mean to be rude on my phone I had a comment from a parent who was very upset, basically saying, you put this rule in place you're basically coming into my home, and we bet share in your home. This is what's best for us. This is what we can afford. And, you know, this rule would necessarily impact that negatively. And my question is, did we look at whether some of the underserved communities or whether the diverse communities would be hit harder by this rule than others. And it seemed to me based on that, the comments I received that could be an issue. I don't want to see it happen either. That's fine. If we didn't do it, that's fine. You know, I just wonder based on a comment. Well, thank you very much for that question comment. It looks like Dwayne Bonfest wanted to weigh in for a second. Yes, and I'm doing somewhat a little bit on behalf of Rizana who had some audio difficulties. First question first about looking at the availability of products and so forth. We did take a look at that issue. We know that there was extensive interest in the in bed sleepers as a, and, for example, baby boxes is one of very inexpensive products that that could be acquired. We took a look to make sure that the in captured in the in the staff briefing package is discussions of that as what's what Susan was mentioning that overlap. We found many products, for example, on the bedside sleepers that were at or below infant sleeper in bed sleeper prices. Okay, I'm not talking about prices though, Dwayne. I'm talking about if you if a product doesn't fit into the standard is going to be an argue the point but effectively banned. And if somebody is not able to get a product, the prices don't matter. They want a particular product that doesn't meet the standard that they're now or practice that they're using now, they won't have any access to any to don't have to go to something else. And that was my concern. Okay. And I think you've articulated that very well I'm going to turn out a Commissioner Feldman. Do you have a quick additional questions or comments. I do and as I said earlier, most of my questions, I would like to address in in close executive session and I'm glad that we're going to turn to that after after we're done an open session. But if we have the technical capability, I still have to ask Steve McGuggan, how we would do that, but we've had the technical capability to do any number of close briefings previously so I don't see that. I'm just saying given the exact platform that we're using right now, it might be that he would have to send a new invitation for us to join in a separate executive session and we just need to consult with him. Again, to circle back to Dana's line of questioning here. I'm still not hearing an answer to this specific question. Did staff look at socio economic and cultural considerations and the impact of the final rule on those and if so, what did you look at and where those finding I would say that we will get back to you with more information on that because I don't want to over speak misspeak. So I will get back to you with that answer. Okay, so that's a yes or no. We looked at a variety of things and that's what I just don't I don't want to misspeak and say the wrong thing right now. So I will prepare an answer and provide that for you. Okay, I appreciate that. And I look forward to seeing that response. Following up on a question a lot of questioning that that Commissioner K was engaged in in the first round. Listen, I understand that CPSC and staff has been in in engaged with ASTM in the subcommittee on a rolling basis and ongoing basis for some time now. But I also didn't hear an answer to the specific question of, you know, exactly when the discussion shifted from inclined sleep to flat product. When did that shift occur. Well, I would say, as we addressed in the SMPR, when we, when staff recommended and the commission published the SMPR, the throughout the package, we said we were removing the term incline, because the incline was the hazard and therefore we were removing the incline and including all products that were for infant sleep that did not meet one of the five CPSC regulations. So that was clearly stated in the in the SMPR by removing the term incline and including all products that were not currently addressed by the five sleep standards. Those discussions occurred after the SNPR issued. They were in the SMPR. I'm sorry, I didn't quite get that. Yeah. No, yeah, I think you asked that again, Peter, I missed the asset again. Whether or not the conversation with ASTM pivoted from inclined to to sleep product. When did that happen. And I'm being told that that happened after the SMPR issued. Again, if I could jump in. So I, we, as Miss Kish noted earlier in the presentation, we had been working with ASTM for many, many years on a range of products, including not just the incline sleep products, but also a number of the flat sleep products, including some of the products such as baby boxes and so forth. So we have been engaged for multiple years with ASTM and the and the community at large on not just the incline, but also the flat sleep products. But the pivot with respect to CPSC's involvement and rulemaking on our end really took took a pivot in the ASTM discussions after the SNPR issue that that makes sense. I understand that. And I understand that the conversations with with ASTM have been on a rolling ongoing basis and have covered any manner of safe sleep. Yes. They certainly have covered any manner of safe sleep. And I think that you're correct that when the commission published the supplemental notice of proposed rulemaking, it signaled a change in that regulatory approach from what would have been proposed in the NPR, which was focused on incline sleepers to again encompass the broader range of products. That makes sense. And I want to be respectful of time. We've had any number of stakeholder forums on the incline sleep issue. Yes. If we had a CPSC stakeholder forum that that focused on on flat. So Peter, Peter, may I jump in here because you're asking, I think you're asking the same question I was trying to ask. And Miss Kish, I think helped. You mentioned we remove the incline. And that was done after the SNPR was issued. The SNPR asked for comments on incline, not removing the term incline. We really haven't gotten comments or public comments or input on the removing the incline part. I think is what happened. And that's why I'm struggling with that issue. Is that right? In the SNPR, we did specifically ask questions about how the term infant sleep product would impact other products besides the incline sleep products. So we, we did ask a number of questions related to the flat products. Okay. But, but, but our SNPR included included, we didn't remove the concept of incline until after that was already issued. That was the purpose of the SNPR. If I might, that was an issue specifically raised in the SNPR. So I think if the issue is the legal sufficiency, I'm quite comfortable that the legal sufficiency has been met. But if I understand. No, it's not legal sufficiency that I'm challenging. The policy matter, did we, did we hold sufficient consultation? And that's something I know staff is constantly consulting on, but that that's something that you can get back to us on. But, but you, but you mean, which what I'm struggling with is I think Ms. Kish said they removed the term incline after the SNPR was issued right. The SNPR is where we remove the term incline. That's the whole SNPR package. That was the basis. It was removing inclined and including all products that were not already covered by one of the five regulations. And I'll just supplement that, that there are a number of comments and responses and I'll point to comments four through seven or so that get at this issue in some detail. They get at the issue, but that's different than sweeping all other sleep products into this role that there are two different things there. I'm sorry. Yeah, these are issues that couldn't be fully discussed when we commission comes to a vote and there are certainly issues that can be explored further. And thank you for raising the issue. I just want to make sure that we've got any and all questions that commissioners want to ask during this, this briefing. I still had just two more questions and I'll be brief. So following up on one of Dana's earlier questions with respect to the man and study. Ms. Kish, I know that you promised that you'd get back to us with whether or not it had been peer reviewed in doing that. Can you also provide a list of who was on the peer review committee? I will, I will include that if I can get that from Dr. Manitz. Okay, thank you. And finally, when we're talking about flat products, admittedly, not being apparent, these are some products that I'm not intimately familiar with. But I'm looking at the product description and some of the photos that you've included and it seems fairly comprehensive in the package that you put together. Thank you. But when we're talking about hammocks and in bed sleepers and some of these other other products. Is there anything here that sort of falls in the category of just being textile products that it's sort of fabric and batting as opposed to something more rigid and structural, like a bassinet? I'm sorry, you broke up, just the important part. Could you repeat that? In reviewing the product descriptions and some of the photos that you've provided, my question is, is there anything here when we're talking about hammocks or in bed sleepers that fall into the category of sort of purely textile products that are fabric and batting as opposed to something rigid and structural, like a bassinet? So I would say that in the hundreds of home-based manufacturers, there are a wide variety of in bed sleepers that come with all types of materials. So I don't want to say they all are. I'm sure that there are products out there that could just be a fabric with some kind of huffy side or hillary side that they have created. Okay, I appreciate that. Again, as I said, I do have further questions, but they're not appropriate for open session. So again, Miss Kish and Dwayne and Mary, thank you all for the presentation. For now, I have no further questions. Thank you. Thank you. I want to make sure Commissioner Kaye, Commissioner Bianco, any additional questions at this point? Thank you, Mr. Chairman. I'm sorry. Sorry. Go ahead, Commissioner Bianco. I was just going to have a lot of questions, but I don't think that the list is appropriate for this particular thing. I think we're going to have to round up a different way. Sorry, Elliott. Okay. There will be additional time for additional questions before we actually turn to a vote on this. And so I'm certainly staff will be able to answer your questions. I want to tell you how delighted I am at the briefing that you've given us Celestine. That's a grueling morning to spend. And I think it a really terrific job. So thank you so much for that. And thank you, Mary House, for all the incredible work you put in in helping develop these packages and making sure they're legally sufficient. What we want to do now is see if Jen Sultan is available. So if we were to move to executive session, I have two questions. First of all, how do we do it technically and secondly, Jen, if we were to do that Commissioner Feldman had not raised the prospect of moving to executive session before, so I hadn't thought this through is, is that something we need to take on in order to move to executive session, and then I'm going to ask Steve McGuggan, what the, what the technicality that the technical challenges of doing that are. So for what it's worth, Dwayne just sent around a notice for a session at one. The problem with that is I have a different, I have another call at one. So I think if we're able to do it, it's just a matter of when we do it. Yeah, well that that gets into a whole question of logistics Steve McGuggan, are you there. Yes, I'm here. Hi Steve just in turn. Well, I haven't heard from Jen Sultan. Is that something that we need to take a vote to do or is that something we can just automatically move to an executive session. I have to admit that I'm still trying to figure that out but it doesn't appear at least directly addressed in the DMP is as far as a vote. I can't if there's a if there's an agreement to move into an executive session that seems sufficient. Okay, well that I hearing no objection and I look for any objections to moving to executive session. Okay, well then, if it requires an affirmative vote, I'm sure you can let us know and unfortunately, if Commissioner Bianco is unable to join us at one o'clock. And can you tell me what the technical challenge would be of moving to what it is. It's 1125 something like 1145 to, would that give you sufficient time Commissioner Bianco. Yeah, I just have to be on a one o'clock call so I would just open it on this and move to. Yeah, if not if not then I suppose we could schedule an executive session for a different time but Steve McGuggan. Can you help us set up for a an executive session that's closed. I don't think that's technically yes. Okay, so you will send around an invitation to join. And I'm going to pick a time at 1145 so that we can move to executive session. Correct. Okay, I will do. Thank you. All right, so again, thank you all for joining us for this public session. And thank the staff once again for a really, really excellent job and I know it's been a grueling morning but you acquitted yourselves extreme. Okay, so I'll see everybody at 1145. Thank you. Thank you.