 Good morning and welcome to this public meeting of the consumer product safety commission before we start. I want to confirm that commissioners are not in this room can see and hear us. Commissioner Felbin, I'm here. Can you hear me? Yes, we can hear you. Fantastic. Thank you. Alex. Of course. At this meeting, CPSC will brief the commission on a draft nose, proposed rule making that would establish safety standards for nursing pillows and nursing pillows can be useful tools for parents and caregivers. Feeding infants, but as this briefing will show, they can also create serious hazard for babies when used for resting or sleeping. Staff has identified more than 150 deaths nursing pillows over the past decade. I'm confident this commission can find a path forward to a rule to preserve the function of nursing pillows on mitigating this hazard. This briefing is based on extensive study and data collection and I appreciate all the work that the staff has done in its development. In a moment, I'm going to turn this meeting over to the staff so they can brief us once we've completed the briefing. Each commissioner will have 10 minutes to ask questions of the staff as multiple rounds necessary. It's a reminder if you have questions that address the agency's legal authority or other legal advice, please don't ask them at this time. We'll hold closed executive session at the end of the briefing if requested. Briefing us today are Timothy Smith, project manager, director for engineering sciences and Elizabeth Layton attorney, regulatory affairs division, office of general counsel also joining us today are Jason Levine executive director, Austin Schlich, general counsel, Dwayne Ray, deputy executive director, Dan Weiss, assistant general counsel on our borough mills, the commission secretary. I'm going to now turn the microphone over to Mr Smith and Miss Layton. Thank you and good morning, Mr chair and commissioners. I'm Tim Smith project manager for the nursing pillows rulemaking project as the chair mentioned today, Elizabeth and I will discuss staffs draft proposed rule for nursing pillows. Next slide please today's presentation will begin with opening statements from Elizabeth on the underlying statutory framework for this rulemaking. Then I will provide an overview of the product and other background information, review the incident data and hazards associated with the product and discuss other information relevant to the development of staffs draft proposed rule. I will then describe the draft proposed rule and the potential small business impact of the rule, followed by staffs final recommendations. Now I will turn the presentation over to Elizabeth who will provide a statutory overview for this rulemaking activity. Next slide please. Good morning, Mr chair and commissioners and thank you, Tim. The commission is required to issue consumer product safety standards for durable infant and toddler products using the notice and comment procedure in the administrative procedure act. Section 104 b2 of the consumer product safety improvements act, the CPSIA requires the commission to promulgate standards for durable infant or toddler products until it has done so for all such product categories. As the DC circuit court of appeals has affirmed the commission not only has the authority to regulate durable infant and toddler products for which no voluntary standard exists. It is required to do so by section 104 b2 express statutory command to regulate all categories of infant or toddler products. Again, that was from the DC circuit decision in the Finbin versus CPSC case in 2022. Next slide please. Because there is no existing voluntary standard addressing the suffocation and fall hazards associated with nursing pillows, the commission is not required to meet the procedural standards in section 104 b of the CPSIA for developing a rule with reference to an existing voluntary standard. Further requirements of the APA, the administrative procedure act, the draft notice of public rulemaking, excuse me, the draft notice of proposed rulemaking initiates a notice and comment process for developing a final rule. Now I'm going to turn it back over to Tim to discuss the staff's recommended draft proposed rule for nursing pillows. Thank you, Elizabeth. Next slide please. Nursing pillows are infant products intended to position and support an infant during breastfeeding or bottle feeding. Examples of these products are shown in the images on this slide. These products are generally rest upon or are worn by the caregiver while seated or partially reclined. Nursing pillows are most commonly CU or crescent shape to fit closely around the caregivers torso, but other designs exist. Most products are filled with synthetic batting or foam, but products filled with cotton, wool, or dried grains are available. In addition to providing a support surface for infants, nursing pillows provide support to the caregiver by raising the infant to the desired height for nursing. This can reduce strain on the caregiver and can reduce pressure on the caregiver's abdomen by providing a surface between them and the infant, which is especially helpful for caregivers who are recovering from a caesarean section. Some products include a strap or belt sometimes with a buckle to secure the product to the caregiver's body and a few have restraints that attach the infant to the product. Some nursing pillows are marketed solely as a support for nursing or feeding. However, many also are marketed for secondary uses such as for propping or tummy time. Many nursing pillows function as sitting or lounging aids for infants who have not yet developed the core strength to maintain a sitting position on their own. In these cases, the infant generally is propped up within the crescent shaped opening where the caregiver's body would be located when the product is used for nursing. And the ends of the product curve around the infant to provide lateral or side support to the infant. Examples of these are shown on the right. Some products that originally were marketed for secondary uses like propping are no longer marketed for such use and focus instead on the nursing or feeding function. Next slide. In 1992, pursuant to the commission's authority under the Federal Hazardous Substances Act or FHSA, the commission banned any article known as an infant cushion or infant pillow and any other similar article that has all the following features. As a flexible fabric covering is loosely filled with granular material, including but not limited to polystyrene beads or pellets is easily flattened is capable of conforming to the body or face of an infant and is intended or promoted for use by children under one year of age. Next slide. However, there's an exemption to this ban for the Boston bill is nursing pillow and substantially similar nursing pillows that are designed to be used only as a nursing aid for breastfeeding mothers. Examples of products that fall under this exemption are described in the FHSA and include nursing pillows that are tubular and form see or crescent shape to fit around a caregiver's waist. Round in circumference and filled with granular material. Products that are subject to this exemption are included within the scope of the current rulemaking for nursing pillows and would need to comply with the proposed rule. The draft proposed rule does not alter the FHSA ban or the exemption to that ban, which would remain in place. Next slide. That search of the consumer product safety risk management system and national electronic injury surveillance system databases identified 154 fatal incidents reported to CPSC from January 2010 to through December 2022 that are associated with nursing pillows and involve infants up to 12 months of age. Nearly all reported fatalities involved an infant six months older younger and almost three quarters involved an infant no more than three months old. The official cause of death and nearly all reported fatalities was asphyxia, suffocation, sudden unexpected infant death or suicide, sudden infant death syndrome or SIDS, which is a subtype of suicide or similar. It can be difficult and often impossible to distinguish between SIDS or suicide deaths and suffocations or asphyxiation with a soft object. Also, in those cases where a medical examiner reported the cause of death as suicide or unknown asphyxia generally couldn't be ruled out. So staff did not distinguish among these causes of deaths. Almost all fatalities involved the use of the nursing pillow for sleep and these cases all often involved additional unsafe sleep conditions, including co sleeping or the presence of other soft bedding such as bed pillows or blankets. More than 80% involved the nursing pillow being used in or on a sleep product such as an adult bed or mattress, a crib, a portable playpen or a bassinet. Few incidents occurred while the product was being used for nursing or feeding but three cases did involve a nursing caregiver who fell asleep while nursing resulting in them entrapping or overlaying the infant. The reported fatalities were largely unwitness and many cases had insufficient details to enable staff to determine the hazard pattern or scenario. However, infants commonly were found with their face pressed into the nursing pillow itself or into another nearby product or surface after turning, rolling over or rolling off of the product. Some infants were found in contact with the nursing pillow, but with their neck hyper flexed and the head pressed against the chest or the neck hyper extended and the head tilted backward over the top of the product. Next slide. Although reported fatalities or staff's primary concern staff also searched for non fatal incidents associated with these products to identify other possible risks of injury. Staff identified 88 non fatal incidents and consumer concerns. Many of these cases were various consumer concerns including complaints about skin irritation from the material, a strong odor from the product or product integrity issues such as the filling material coming out of the product. However, staff did identify numerous cases involving the infant falling or rolling out of the product and most of these cases involved falls from an elevated surface such as a couch or bed. In nearly all fall related cases, the infant was left in the product unattended. Two fall related incidents involved the infant being carried while in the product. The incident data as a whole suggests that nursing pillows rarely pose a risk to infants while being actively used for nursing or feeding and that the primary use pattern that leads to injury or death is the use of these products for lounging or more concerningly for sleep. So nursing pillows that pose the greatest risk are those that are intended marketed or designed for infant propping or lounging without the presence of a caregiver. Next slide. In September 2021, CPSC initiated a task order with Boise State University for research on pillows intended for infant care and use which included an analysis of the risk of injury or death to infants associated with the use of infant pillows including nursing pillows. Boise delivered a final report to CPSC on the results of its research in June 30 of 2022. The report includes recommendations and conclusions related to the performance and design of nursing pillows. For example, Boise recommended that all nursing pillows be required to undergo firmness testing to demonstrate that the product has firmness that is comparable to crib mattresses because products that lack firmness are more likely to conform around an infant's nose and mouth and to present a suffocation hazard and crib mattresses are generally considered the safest place for an infant to sleep. Boise recommended that products that do not pass firmness testing be required to pass an airflow test that would demonstrate that the product has airflow characteristics comparable to mesh crib liners. Boise also concluded that nursing pillows that are firm and feature sharper corners rather than cylindrical sides are likely the safest option for infants because these products couldn't reasonably be used for lounging and might discourage such use. Next slide. As part of their work to develop a firmness requirement, Boise developed a three inch diameter anthropometry based hemispheric probe that is representative of the size and shape of an infant's face. This probe is attached to a force gauge and is applied to the product at three locations, the location of maximum thickness, the location of minimum thickness, and a separate location that seems particularly soft or is otherwise most likely to result in failure. The required force to displace the probe one inch into the product at each location must exceed 10 Newtons or about two and one quarter pounds, which is a force that is comparable to tested crib mattresses. Boise's testing of sample nursing pillows to this firmness requirement found that although most products as currently designed would fail, some products were able to pass or nearly passed. And staff is not aware of any fatalities associated with the products that pass this requirement. Next slide. There are no published US voluntary standards for nursing pillows. However, ASTM has established an F 15.16 subcommittee on infant feeding supports and staff has been working with the subcommittee to develop requirements intended to address the primary hazards associated with nursing pillows. In March of this year, ASTM issued a ballot that included a preliminary draft of the infant feeding supports voluntary standard. Nursing pillows are included within the scope of products covered by the draft voluntary standard and are treated as essentially synonymous with infant feeding supports. The ballot closed in April and received many negative votes and other comments, including comments from staff. These comments were sent to the relevant task groups to be addressed and work and work in the subcommittee has been ongoing. On August 21st, last week, ASTM issued a ballot that includes a revised draft of the ASTM voluntary standard for infant feeding supports. This ballot closes on September 21st and staff currently is reviewing the ballot. Next slide. The initial draft voluntary standard reviewed by staff included requirements typically found in other ASTM juvenile products standards, such as requirements for lead prohibitions against small parts hazardous sharp edges or points and removable protective components and permanency requirements for labels and warnings. The draft standard also includes four main performance requirements. A requirement that prohibits all in scope products from including infant restraints, which can entangle an infant and could invite misuse by suggesting to consumers that it's acceptable to leave an infant unattended in the product. A requirement intended to address product integrity issues such as seam failures and material breakage. A firmness requirement largely based on the recommendations from Boise and their infant pillows research report. However, the requirement was expanded to be applied not only to the top infant support surface, but also to the inner wall of the crescent like opening of these products. And an occupying containment provision that applies a nine inch diameter probe to the opening of the product. When the probe is moved through this opening, it cannot contact the sidewalls of the product. This requirement was intended to reduce the potential for an infant's head to become entrapped within this opening and also was intended to reduce the extent to which these products can be used for infant propping or lounging by limiting the ability of the product to envelop or contain a young infant who might be placed within the opening. The draft voluntary standard also included marking and labeling requirements that include a permanent and conspicuous warning that must appear on all products covered by the standard as well as requirements for instructional literature to accompany the products. I've mentioned the draft ASTM standard here and elsewhere, so I want to be clear this ASTM standard is still in draft form and is not completed the full consensus process to be an approved standard. The draft language so therefore is subject to change. Next slide please. I've considered the appropriate scope for the draft proposed rule based on the nursing pillow market, the existing FHSA infant cushion ban and associated exemption and the draft ASTM voluntary standard for infant feeding supports. The draft proposed rule defines nursing pillows as shown here. Any product intended marketed or designed to position and support an infant close to a caregiver's body while breastfeeding or bottle feeding. These products rest upon wrap around or are worn by a caregiver in a seated or reclined position. The draft proposed rule includes maternity pillows, also known as pregnancy pillows, which are intended to support a pregnant adult's body during sleep or while lying down and sling carriers, which are already required to meet CPSC's sling carrier safety standard. This definition is broad enough to encompass all nursing pillows on the market and within the available incident data and is similar, very similar to the preliminary definition developed by the ASTM infant feeding supports subcommittee in coordination with CPSC staff. Next slide. Staff recommends that the draft proposed rule include many of the general requirements included in the draft ASTM voluntary standard to address the potential hazards associated with lead in paints, small parts, sharp edges or points and the removal of protective components. However, staff recommends that the requirements to prevent the removal of protective components be expanded to include other possibly detachable components that are accessible to the infant, such as zipper pulls and buttons. If detached, these parts can expose the infant to hazards such as sharp points, sharp edges and choking hazards. Staff also recommends that the proposed rule include warning permanency requirements consistent with those in the draft voluntary standard, but with an additional warning permanency requirement that would address free hanging labels. That is, labels that attach to the product at only one end of the label. Free hanging warning labels are more likely to be torn or ripped off, which would eliminate the potential safety benefit of the warning to future users of the product. Next slide. Like the draft ASTM voluntary standard, staff recommends that the proposed rule include a requirement that prohibits all nursing pillows from including an infant restraint system. This requirement addresses the potential risk associated with infants becoming entangled in such a restraint. In addition, staff is concerned that the presence of infant restraints could suggest to consumers that infants can be left unattended in the product. Staff also recommends that the proposed rule include a requirement to address seam failures with nursing pillows. Specifically, staff recommends that nursing pillows seams be subject to a tension test similar to that applied to toys in ASTM F 963, but tested at a higher tension force of 15 pounds rather than 10 pounds because nursing pillows may be used for multiple children or passed on to other caregivers. Staff is aware of one injury associated with seam failures where an infant reportedly choked on filling that came out of the product, and staff has received additional reports of non-fatal incidents involving similar product integrity issues. As I noted earlier, some nursing pillows, particularly those intended solely for nursing, include a buckled belt strap or other feature intended to secure the product to the caregiver. During nursing pillow use, the caregiver may engage in repositioning or similar activities that could result in these caregiver attachments bearing the full weight of the infant who is supported by the nursing pillow. So staff recommends that the proposed rule include a requirement for the strength of these attachments, if included on a nursing pillow, to address the potential for infant falls if the attachment fails. Although staff is not aware of any incidents associated with caregiver attachments failing, we are aware of one report of a crack in a clip on a product that could be relevant to this issue. Specifically, staff is recommending that each element of the caregiver attachment system that is included on a nursing pillow be required to withstand a static load equal to the recommended weight limit of the product, or 20 pounds, whichever is greater. Next slide. Staff recommends that the proposed rule include a firmness requirement that applies to each infant support surface on the nursing pillow, as well as the inner wall of the nursing pillow opening. Staff's recommended requirement and test method are based on the recommendations in Boise's Pillow's Research Report to CPSC, with the additional requirement to test the inner wall of the opening, similar to what is included in the draft voluntary standard. The test applies a three inch diameter hemispheric probe to three test locations on each surface. To meet the requirement, the force required to press the probe one inch into each test location must exceed 10 newtons, which results in product firmness that is comparable to crib mattresses. The diagrams on this slide illustrate the firmness test being applied to two surfaces of a nursing pillow. This requirement is intended to reduce the likelihood that the infant support surface or the interior opening of the nursing pillow can conform to an infant's face and pose a suffocation hazard, and addresses the numerous fatalities where the infant was found with their face into the product. Next slide. Staff also recommends that the proposed rule include an infant containment provision that limits the degree to which the opening of the nursing pillow can envelop or provide side support to a young infant, thereby limiting its potential use for lounging or sleep, while also reducing the potential for the infant's head to become entrapped within this opening or for the product to restrict a young infant's head movements if the infant found themselves face down in the opening. The red outline and shading overlaying the images shown on this slide illustrate the amount of side support offered by each of several sample nursing pillows on the market. The three nursing pillows on the left are ones that are intended solely for nursing, while the three on the right are or have been marketed for both nursing and lounging, and you can see the ones intended for lounging offer considerably more side support for an infant who is placed in this space. The openings for these products are also smaller and more infant sized rather than caregiver sized, because it may be difficult to visualize this. I'll now demonstrate the amount of support that's offered by two sample nursing pillows that I have here. So, this one is one that you can see that the size of the opening is one that fits the infant precisely, and there's no movement of the infant if the infant is placed in this product. And it also provides that extra sort of side support that wraps around the infant so that if the infant is unable to sit unassisted, it holds them into the product. So, this is what we don't want because this allows for lounging. Contrast, you can see the opening is much wider. There's a lot more play in the opening, which would allow an infant who is unable to sit without support to move around more easily. It also provides considerably less side support, so if an infant started to move, they could roll right off of the product. Next slide. This slide summarizes how to assess a nursing pillow for infant containment. There are two basic requirements. When a nine inch probe is placed against the rearmost opening of the nursing pillow opening, the probe must extend beyond the opening of the nursing pillow. And when the probe is moved out of the opening, the probe cannot make contact with any surface of the nursing pillow. I'll demonstrate how you would perform this assessment using two sample nursing pillows. I'm going to use the same one for the first one. Here is the probe. So, first you would take it and you would place it in so that it is in contact with the rearmost portion of the pillow. Now, in this case, this is actually a failure already because you, if you're unable to just place the probe into the opening without it making contact, then it's a failure. But assuming that this actually was able to sit in there without me pushing it in. In this case, if you were to try moving it out, you can see it's actually making contact with the nursing pillow here on the front side of the probe. So that would be a failure. Also, if you look at it from the side, in this case with the probe in the rearmost portion of the pillow, you can see that the nursing pillow itself extends beyond the end of the probe. So that means it's providing too much lateral support to an infant if they were placed in there. Different sample. So if you take the product again, place it so that it is in contact with the rearmost portion, you can see that the sides do not extend past the probe. The probe extends further than the ends of the nursing pillow and you can slide it out without it making contact with any part of the nursing pillow. Now, we also have a requirement for the caregiver attachment. First, you perform the exact same two tests, except first you perform it without the caregiver attachment secured, which is identical to what I've just done. You then also have to perform it with the caregiver attachment secured and it has to be adjusted to the tightest or the minimal length that it allows. So in this case, if you were to do that, this, although it would have been a pass, had it limited it so that you could not tighten it this far. In this case, by tightening it, it's pulling the sides in so that it's still making contact with that outer half of the probe. So this is a failure too. The staff recommended that the ASTM infant feeding support subcommittee include a provision to limit infant containment in its draft voluntary standard and the requirement we are recommending for the proposed rule is similar to the occupant containment requirement that appears in that draft. However, staffs recommended requirement includes the additional requirement that the nursing pillow cannot extend beyond the opposite end of the probe and requires testing to be performed both with and without any caregiver attachment secured. That's requirement eliminates certain designs of nursing pillows that have been marketed for lounging and are known to be used for infant lounging and sleeping, which is the primary hazard associated with nursing pillows. And staff concludes that this requirement combined with the firmness requirement will reduce the likelihood that consumers will use the nursing pillows for infant lounging and sleep. Next slide. That had considered but is not currently recommending other performance requirements in addition to those included in the draft proposed rule. For example, in its infant pillow research report CPSC, Boise recommended that nursing pillows that do not pass firmness testing be required to pass an airflow test that would demonstrate the product has airflow characteristics comparable to mesh crib liners. However, Boise also stated and staff agrees that airflow testing is not needed for a product that passes the proposed firmness testing because a firm product is unlikely to form a seal around an infant's nose and mouth. Because staff is recommending that all nursing pillows be required to meet firmness testing that is at least as stringent as the that recommended by Boise. And because the ASTM infant feeding supports subcommittee includes a similar firmness requirement for all infant feeding supports in its draft voluntary standard staff concludes then airflow requirement for nursing pillows is unnecessary. Boise also noted that some products that are marketed solely for nursing include features like sharper corners that do not easily facilitate lounging and concluded that nursing pillows that are firm and feature sharper corners. Rather than cylindrical sides might be the safest option for infants because there would be no reasonable way for consumers to use such a product as a lounger. Although Boise did not provide a specific recommendation for an angular requirement or test method staff did consider the possibility of such a requirement. Although staff agrees that nursing pillows with sharper edges might in principle discourage some consumers from using the product for infant lounging. Staff is not recommending such a requirement at this time because of concerns about the potential for such a requirement to inadvertently increase the risk of positional asphyxia by neck hyper flexion or hyper extension. If the requirement were ineffective in discouraging consumers from using the product for infant lounging. In addition staff concludes that the infant containment provision in the draft posed rule is likely to discourage use of product for lounging and sleep. Staff recommends seeking public comments on these issues. Next slide. Compared to the performance requirements described earlier, warnings are unlikely to be very effective in addressing nursing pillow hazards. However, well designed warnings can serve as a secondary safety mechanism by providing consumers important information about the hazards associated with these products and appropriate behaviors to avoid these hazards. The staff recommends that the proposed rule include requirements for a prominent strongly worded on product warning that addresses the primary hazards associated with nursing pillows with particular emphasis on the deadly potentially deadly consequences of using these products for naps or sleep and of leaving infants unattended in the products. Staff's recommended warning is shown here. This warning would be required to be visible to a person placing an infant on the product. In addition to on product warnings, the draft voluntary standard includes requirements for product packaging to include warning statements about not using the product for sleep or in sleep products like cribs, bassinets or play yards. Information about the manufacturers recommended weight, height, age or developmental stage. Prohibition against, oh, and a prohibition against other warning statements or graphics that indicate or imply that an infant can be left in the product without an adult caregiver present. That includes these requirements in the draft proposed rule. That also recommends that the proposed rule include requirements for instructional literature that must accompany nursing pillows based on similar requirements in the draft ASTM voluntary standard. Next slide. As required by section 603 of the regulatory flexibility act, staff prepared an initial regulatory flexibility analysis describing the possible economic impact of the draft proposed rule on small entities, including small businesses. Staff has identified more than 1000 businesses that supply nursing pillows to the US market. Most are small US manufacturers, importers or US non employer businesses, which includes small hand crafters that ship to the United States from the United States. Most nursing pillows on the market will require redesign to meet the requirements in the draft proposed rule and these one time redesign costs, including the cost to design warning labels and instruction manuals will be potentially significant for a substantial number of small firms for the first year that the rule is effective. Next slide. For most small firms, the impact of redesign costs and ongoing third party testing costs to certify compliance with the rules likely to be significant, meaning at least 1% of annual revenue. Many small volume hand crafters might stop selling nursing pillows. However, even relatively small volume suppliers with sales under 1000 units per year might be able to reduce the impact of the proposed rule by raising prices to cover the cost of testing and redesign. A retail price increase of less than $5 could cover all testing costs and a substantial portion of the redesign costs, even for a very small supplier. That is recommending a 180 day or six month effective date for the rule, but invites comments particularly from small businesses that provide specific data on the amount of time they will need to come into compliance. Next slide. But based on information presented here and in staff's briefing package, staff recommends that the commission publish a notice of proposed rulemaking with staffs draft proposed rule for nursing pillows with an effective date of 180 days following publication of the final rule in the federal register. And now welcome any questions you might have. Thank you both for the briefing today. It was comprehensive and the very, very thorough going through the package that was presented to us last week. Only have a couple questions and as follow ups and I think you covered many of the things that I was going to discuss in terms of really the characteristics of the products that were associated with the most fatalities and really how the fatality seem related to when being used not for nursing or feeding, but for for sleep or other sorts of leaving the child alone in the product. Is that fair? That is fair. As you said, the Boise State University report concludes that nursing pillows with sharper features rather than cylindrical sides may be a safer option for babies. You discussed the that it's not in the current proposal from staff. Can you explain it go to a little bit more depth as to why and what you would hope to see in the comments being requested. Yes. So, yeah, as I mentioned in the presentation, we do have some concerns just general concerns about the potential increased risk of positional asphyxia, if the infant is still placed in the product. Despite the intention of it discouraging lounging. And one of the big things that we one of the main things that we noticed when we compared products that were intended solely for nursing. Compared to products that were also intended for lounging. The key distinguishing characteristic that we saw between those two products was the amount of side support that the products intended solely for or the products intended for lounging were offered an infant who would be placed in that product. Not how angular the product was. There are actually many products that are intended solely for nursing, for which we have no fatalities that are not angular. So, we concluded really that the the main factor that was the key factor that was important in addressing was the amount of infant containment that is provided and that is what what was the impetus for those requirements for infant containment. And so useful comments might go to some of the other issues that target. Yes, I would say the, the, the most important pieces of information would be actual, any actual data that is available to support what level, how angular, or what, what kind of design features that angular design features would actually discourage the use of these products for lounging because, again, our main concern is, if it is not effective in doing that, then it potentially makes the product more risky in terms of forcing the infant's head in a position that that could pose a risk of asphyxia. Question gears you mentioned the ASTM has a second ballot out and noted that there are some things that were similar to what the staff has put out firmness, for example, are there areas that staff fields are safer within the staff proposal or what the differences are between the two proposals. Yes, I would say that we've been working with the subcommittee to improve the draft. But we still think that the current draft does not provide the level of safety that the draft proposed rule provides, especially with respect to requirements that limit infant containment. At this point, the current ballot would still allow for products that have those long side support arms that enable the product to be used for lounging. You noted that there are over 1000 suppliers out there, some of these coming in from overseas, a voluntary standard if it was put into place is just that it's a voluntary standard as opposed to a mandatory standard that the commission would have to enforce and if there's any product that was problematic, the commission would have to look at that particular product and then determine that it was. Valid in a way that the commission go after it so in that the voluntary standard even if it's out there doesn't mean that everybody will be following the voluntary standard. And that being said, things like firmness, things where there are some similarities, you list in there that it would take time and it would be costly for certain small businesses to do those standards. And it looks like from what I see in the presentation that many of those would have to be done if a manufacturer wanted to meet the voluntary standard much less the one that's proposed here is that fair. I would say that's fair. Yes. So, at this point in time, I'm going to go and turn to my colleagues. I'm going to turn to commissioner Feldman who is remote commissioner Feldman. Mr chairman. Can you hear and see me? Yes, I can. Great. I do want to thank you again for putting on today's public meeting and for staff and Daniel to look at in particular for working with me to participate remotely. I'm joining you all this morning from the wind river reservation in central Wyoming. As part of the agency's equity equity action plan that we approved in May 2023. And informed by research from the Indian health service CDC and others who launched a public health awareness campaign across 10 states with significant American Indian populations. We know that citizens in these regions have lower life expectancies and we know that the majority of tribal lands have limited or no internet access. Which is CPSC's normal means of public safety information dissemination. So we recently launched a multi-state billboard and radio campaign, which is why I'm here today and not in Bethesda. But turning to the issue at hand, I want to thank staff for all of your work. Not only in putting together today's presentation, but also for your hard work and dedication over the past several years. To bring forward an NBR to protect families. It's important that a final rule strike the right balance between protecting against the unreasonable risk that we know to be associated with soft sleeping services. And maintaining the availability of useful products that that help facilitate breastfeeding. It's also important that a final rule be issued on strong legally defensible grounds so that any safety rule that we promulgate can withstand. Challenge and judicial scrutiny as our most recent rule makings have faced a rule that is stayed or overturned offers zero consumer protections. But to both of those ends, I do appreciate staff's presentation and I look forward to putting out this proposed rule for comment. Public comment from consumers, manufacturers, advocates and others. It's a critical part of our process. I look forward to reviewing those comments when we receive them. But our rules also must be data based and rooted in solid science. And with that, Mr Smith, I do want to ask you to talk a little bit more about the BSE report that was provided to the commission by Dr. Aaron Mann and her colleagues. Can you describe her findings and specifically how those findings informed the proposal. So the, the primary findings that she made the primary 1 was the firmness requirement that carried over almost precisely to the requirements that we have added in the draft proposed rule. So we've just expanded them so that instead of applying the firmness to just the top surface of the product, which was how she ended up performing the testing. We also apply it to the interior surface of the pillow. So basically the this part in here. And that was something that. That the subcommittee, they asked him subcommittee also agreed was needed. The that she also then looked at the incidents and it was obvious that most of the incidents and what we found also that most of the incidents. involved use of the product for lounging and sleep. So she suggested an angular or she didn't actually suggest an angular requirement. What she suggested was that there are some nursing pillars available that are angular and. Feeling was that they might not lend themselves to lounging. So, those might be the safest products, but she didn't specifically recommend that as a requirement or suggest any kind of test method for that. She did include some testing with a sagittal plane device. So essentially it's a articulated plate that sort of that represents an infant. And if you place them in the product to get a sense of the angles of the various limbs of the infant. And she had some concerns about the products that are that she tested, which were the ones that are intended for lounging that they posed some angles that she found concerning, but she didn't have any specific recommendations for an angle that is unsafe. And it was more that that's something that needed some ongoing work. Those I would say would be the most significant findings in her report. I appreciate that. Is there other research and data that we're relying on particularly for the the firm is testing or is this informed primarily by what we received from BSE. It's primarily from BSU the. So, there is also the firmness test that is used for crib mattresses, for example. And that was the starting point for the work that she did trying to find something that would result in comparable. Firmness between crib mattresses and other products. The one that she developed was developed specifically with a probe to represent the face of an infant to allow you to test products that didn't have a large flat surface or that were irregularly shaped because the other test device just didn't lend itself to that. So, the sort of crib mattress firmness testing that is done also informs that firmness testing that she developed. That's helpful and I appreciate that response. Last question. Can staff walk me through its determination to treat these products as durable infant nursery products. I've seen instances previously where textiles and textile products have been categorically excluded as durable products. That's not the direction that we're going here. I'm curious if you can walk me through your thought process. So I would say the reason we consider these to be durable is because we know that these products are often used for siblings. They're often passed on to other caregivers to use with their children. And we also know that used nursing pillows are available on the and sold on the secondary markets. So they can maybe in use for several years. So that was essentially the driving factor. I appreciate that. I see that my time is running low. Again, thank you very much for the presentation. Thank you and in the rest of your teams. For all the work that went into this, I will yield the balance of my time. Thank you, commissioner. Commissioner Trump. I am so happy that we're here talking about nursing pillows today. Thank you for bringing forward a solution. Thank you for talking about a path forward and thank you for all the work you've done to get us here and the work that that's going to come. So appreciate it. I guess picking up on that thread with durable that they're also replacement covers for these things sold, right? That is correct. And that extends the life of the products. I would assume so. And these are expensive items. I mean, these these aren't $510 they could go up to $100 and more right. Yes, that's correct. Yeah, I think that would lend to these things sticking around in the market, certainly for resale if you want to recoup some of that cost after you've purchased this. I, for example, am sleeping on a pillow. I think I bought in law school 15 years ago. So these things can last a while. But thank you on that. And then I wanted to understand a little bit about the testing and I'm glad you have that up there. So I understand the probe, how it works on the top surface, because you've got that whatever flat surface underneath it you're pushing down against that. How does it work when you're when you're doing the interior wall what what stops the bill from sliding. The way the draft proposed rules written, it doesn't specify exactly how you would secure the product. It just specifies that you are to prevent the movement of the product without interfering with the the measurement process. So for example, you wouldn't take it and clamp it down in such a way where you're going to be testing firmness on an area that's being compressed. So we left that open to allow test, test labs to figure out the best way to perform the test and for their particular circumstances. It could be you would have some kind of something behind the product in order to prevent it from moving. Because the goal really is to assess the firmness of the product, not if you are pressing into the product and the product's moving you're not actually getting a good measurement. Okay, and is that the kind of thing we would expect to see comments on methods during the product the comment period. Yes, absolutely. Okay, excellent. And then with that same product you showed us before that, and I was really glad to hear you say that with the caregiver adjustment scrapped it has to be ratcheted down to the tightest configuration because that's presumably what you would do if you wanted to use it as a lounger. How does that operate I mean does that have to be while the probe is in the product or tighten it all the way down and then try to put the probe in the product. So the way that the test method is written you actually take it you tighten up the caregiver attachment first to its minimum length, and then you apply the probe. Okay, yeah I did it in reverse because we already had it there but I just wanted to clarify that makes way more sense to me to do later describing now, and that spelled out in the rule. Okay, excellent. I did want to ask about some of the slides if we could put up the slide from your presentation slide 18. It's got the diagram of products. Let's see. It's got the, yeah, there we go. So, so, no, the one you had up a second ago. Thank you. So the products on the right. You talked about products in these ones on the right are designed for a lounging function right. Correct. Okay. And I did have one question on suede and SIDS you described the interaction between the two and you referred to SIDS as a subtype of suede. And the package does as well and I just wanted to get some clarity on that because I had always understood it as a replacement for the term because it's not really a syndrome and it's a rethinking of the title. So, I just wanted to give you a chance to explain our thought on why we're conveying that as a subtype. So suede. Somebody else may be able to explain this better than me probably. So suede is a sort of general term that just describes an unexpected death by some means. If it's an unexpected debt that can be explained that still falls within the umbrella of suede. It's just a specific type of fatality within that. And SIDS. I think it would probably be best for me not to characterize exactly what that distinction is with SIDS and suede. I'm glad it would be better for me to get back to you. Let's do that. Let's think about that and just make sure. Make sure describing it as we mean to in that one. Let's see. Oh, on the warning label and if the slide show this is slide 21, I think it's a few slides after that we have the warning label. Yep. Thank you. And so I had a question on that. The first line on there. It reads using the product for infant sleep or naps can kill. I love the intent, the intent to say, Hey, even for naps, we're still talking about that. But what I have a little bit of an issue with is saying sleep or naps, which says that those are two different things when when all our other guidance says they're the same thing. So I'm curious if there's a way to convey what I think our intent is to say like, be careful with naps to those are also still sleep to convey that without trying without making this distinction that gives people the impression those are two different things. So, you know, if we had said something like infant sleep, including naps can kill infant sleep, even naps can kill. And is there another way to say that concept. I would say that there there possibly is those are two options that maybe would be worth considering so I would say that that's something that we would welcome. Yeah, and I don't want to try to make a decision on the spot. So if we can maybe have a follow up conversation once you've had some time to think about whether those options make sense that that might. And then the second line said babies can turn, scoot or roll over without warning and can suffocate. Again, a very important warning, but I want to make sure I understand what we're conveying, because there's babies that at three months old can't do any of those actions, because they might be able to do it when they're in this product. Is that kind of what we're suggesting? We're so we're suggesting that it could be that when you're using the product that the product would assist the infant in doing that, but I don't. It's not intended to be limited to that. There are many cases where even on a flat surface where an infant ends up in a compromised position and the caregiver reports. They've never done this before they've never turned over before. So it could be a situation where it is the first time when they do it and you. So you need to be prepared for the, you know, or prepared for the possibility that. Your infant can do this whether in the product or not. It's just the fact that because they can do this. This is why you need to make sure that you're not using the product for. All right, I see. Yeah. Yeah. Yeah, I just wanted to make sure we're not having somebody who thinks their baby can't do that already doesn't tune this out. Well, that doesn't apply to me yet. If the product allows them to do it when they couldn't otherwise on a flat surface and something else to think through potentially. And then, you know, we're seeking comment on every aspect of the rule, which is great. And I think it's also important that we're seeking specific comment on something you talked about before with the angular sides. And you expressed staff expressed some optimism for the power of those angled corners and certainly the Boise State suggested there could be some benefit there on dissuading use for sleep. And also that concern, you know, that there this could create another potential problem. You know, but I believe that the height of the product with angled corners could also be relevant to that analysis, whether it's thick or thin. And so I think we might want to see comment on whether paring angled corner requirements should have a height component as we consider it. And that that could be a valuable area for some feedback. And also, you know, whether that would pose more utility for the person using the product, the adult user of the product in terms of positioning and eliminating a hunch while they're doing that a taller product potentially. And then we might also want to see comment on the size of the opening on OS 28 in the briefing package. We say that the proposed rule requires nursing pillow openings to be of a size that is more appropriate for an adult user rather than an infant. And I have some question as to whether nine inches is wide enough to accommodate an adult body in the opening. And I think comment there could also be very helpful. And then in on OS 30 in the briefing pack, actually it's the same image, the same images on the slide we were just talking about that you said were designed for sleep. And you have the ones that are for nursing only and the ones that are nursing and lounging that that right column. And it looked like with that head probe in there, you know, we use the nine inch to look at the length of the side supports as well. And I see some value in that, but it looked like most of the products on that left column, the ones that were for nursing only didn't come anywhere near the nine inches, they were short of the midline, just so short of that four and a half inch midline. And I wonder if we should see comments as well on the length of the side supports and whether it should be closer to that four and a half inches or some other measure. Because you would think if a baby rolls in that product in one of the ones that's designed as a lounger face and those more likely to come into contact with the longer side with a four and a half or shorter like we're seeing in that image face and those less likely to come into contact on rolling. So I'd like to see if we have any information from the public on that. And then the last thing I would say is I look forward to some comments on on effective date as well. Here we're within our normal statutory upper bound. But I'd like to hear from parties who think effective date might be shorter. I might want to be shorter given that labs do seem to have those test probes that we use labs already have those right these are normal sizes that the labs are using for other tests. Testing costs and redesign those those appear to be lower cost than with most rules we've seen in the past, and given how simple the design of pillows are. So the seeming ease of redesign. So I apologize for going over and I appreciate the indulgence. And again, thank you so much for bringing forward solutions on this issue. Thank you for sure. Thank you, Mr. Boyle. Thank you, Mr. Chair and thank you, Mr. Smith for that very comprehensive and thoughtful presentation. I just want to make a couple of comments. The commission has long warned against the use of pillow like infant products and specifically the commission issued a warning in 2020 about nursing pillows used for sleep. At that time, the agency announced it was investigating the entire class of products stressing that when infants fall asleep or left unattended on nursing pillows, they're at risk for serious injury or death. It has been 3 years since that warning. And in my opinion, that is too long. But well, I would certainly have preferred to have been here much earlier. I am happy. We are now finally in a position to consider regulatory options to ensure nursing pillows meet requirements that will reduce the number of fatalities and other incidents associated with the products. I think the proposals before us today recognize the utility of the products while also underscoring that when it comes to our most vulnerable consumers, safety concerns must remain paramount. Striking the right balance between those sometimes competing concerns are difficult, but I am optimistic that we are moving in the right direction, ensuring useful products are also safe. So I thank you for getting us to this point today and I certainly hope that the next stage proceeds without delay so that we can make up for some of the lost time over the last several years. I just have a couple of additional questions to add from those that have already been asked. Specifically on data, you note that over half of the fatalities of which we are aware occurred since 2019. You also caution that because these data are anecdotal, this increase may reflect a change in reporting. But can you just elaborate on that a little bit please. The data issues. Yes, I mean, so. Yeah, we don't know whether there has been an actual increase in. An actual increase in fatalities versus just changes in reporting. However, as you know. The fatalities are higher than they have been and in the 2020, which was the. Last year for which we have complete data, there were 38 fatalities associated with these products. So, yeah, it is something that we are concerned about and why we think that it's important not to delay. Thank you for that. Appreciate it on the report that report indicates that nursing pillows are safest for infants when there's no reasonable way for consumers to use the product for lounging or sleeping. We've already talked about that, particularly in reference to the angular requirements, but I wanted to talk a little bit about the firmness requirements. Do the requirements of the proposed rule meet the spirit of that recommendation given that the firmness requirements are limited to the top and the interior sides only should testing be performed at more than 3 locations. Would that be more protective. I would say that we are open to receiving public comments on that issue. We only tested as you noted they only tested that top infant support surface. So, we have already expanded that to include that interior surface because we've had our aware of incidents where the infant was within that opening and turned their face into the side of the product and ended up suffocating that way. But we welcome public comments on the potentially expanding that further if if that's necessary. Okay, thank you. I just want to clarify something that was in the package staff recommended testing at 3 locations maximum thickness and the 2 most owners locations. How do you define owners and is that. That is so test labs do have to deal with this from time to time. So it is the locations where based on the testers experience with the product working with the product identifying those locations that seem like they are. After more likely to result in a failure. It also just generally means that manufacturers are responsible for making sure that the firmness. Requirement applies across the entire surface of the product because it's not specifying a particular location that must be tested here. Which means they can't. Make sure that location is firm while letting the rest of the surface be soft. Okay, thank you for that. And sort of similar lines in terms of staff recommending not firmness requirement, but not both a firmness and airflow requirement. Wouldn't it be more protective to have both in terms of adding additional layer of protection as opposed to concluding that it's unnecessary. Can you just elaborate a little bit more on that whether having both would actually add something at an element of safety to the product. I would say it's unclear whether having both is this would necessarily be. More protective than just firmness. We. Of all the products that have been tested for firmness. There are some products that are intended solely for nursing. That actually can meet the firmness requirement. I am not convinced it could meet as it's currently designed an airflow requirement. Yeah, we have no fatalities involving those products. So the products that meet firmness seem to address the hazard. Okay, thank you. And just 1 last question again, it's just really for explanation for my understanding in terms of the angular requirement. I think you indicated that there are uncertainties on on the past fail criteria. And you may have addressed this, but can you just explain that to me 1 more time what would be what uncertainties we would be talking about. It really surrounds the issue of what level of. Angularity, not sure if that's actually a word, but how angular does the product need to be. For it to be sufficient to discourage lounging and what that what you would set as the appropriate angle to do that and. That's being balanced against the fact that as you make the products more angular, if they're firm, then they potentially it potentially increases that risk of positional asphyxia. So that that's really what it comes down to in terms of the past career, past fail criteria. What is that angle that actually accomplishes the goal of discouraging lounging. Okay, thank you very much. And again, thank you for the presentation. I have no further questions. Mr chair. Thank you. Thank you, commissioner. Do any of the commissioners request another round. Hearing none, I want to thank the staff for this informed briefing and the commissioners for their participation. I do ask at this time also if my fellow commissioners have any legal questions that they want to ask in a closed session. Hearing none again, thanks to the staff for for putting this together and for all the work that they've done over the years to get to this point. I also want to thank our facilities and communications. Staff and the offices secretary for assisting and putting together this briefing. And with that, this briefing is adjourned and we're going to now take five minutes to clear the room for our next close compliance briefing.