 Good morning and welcome to the public meeting of the consumer product safety commission. This meeting, CPSC staff will brief the commission on a draft notice proposed rulemaking that would for the first time establish safety standards for infant support cushions. From 2010 to 22, we know of at least 79 deaths and additional 125 incidents with these products. This proposal will establish a safety standard for infant support cushions, durable nursery products to fulfill our obligations. Intersection 104 of the Consumer Product Safety Improvement Act. In a moment, I'll turn this over to staff so they can brief us. Once they've completed the briefing, each commissioner will have 10 minutes to ask questions with multiple rounds if necessary. As a reminder, if you have any questions that address statutory interpretation or legal advice, please don't ask them at this time. We can hold a closed executive session at the end of the briefing upon request. Briefing us today are Dr. Stephanie Marquez, Project Manager and Supervisory Scientist Division of Health Services Pharmacological and Physiology within the Office of Hazard Identification and Reduction. That's quite a mouthful. And Ms. Elizabeth Layton, Attorney, Office of General Counsel. Sorry that you don't have a longer title. I will now turn the microphone over to Dr. Marquez and Ms. Layton. Thank you. Thank you. And good morning, Mr. Chair and commissioners. I'm Stephanie Marquez, the Project Manager for the Infant Support Cushion Rulemaking Project. As the Chair mentioned, today Elizabeth and I will discuss the asked-or-off-proposed rule for infant support cushions. Oh, I guess 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 the other background information. There's some in you. Try again. Then I will provide an overview. I think it's working, yes. The product and other background information. Review incident data and hazards associated with infant support cushions. Discuss information relevant to the development of the staff proposed rule. Describe staff's proposed rule and the potential small business impact of the proposed rule. And finally, present staff draft recommendations. Now I will turn over to Elizabeth who will provide the statutory overview of this rulemaking activity. Thank you, Stephanie. Good morning, Mr. Chair and commissioners. Under Section 104B of the Consumer Product Safety and Proven- Oh, I'm sorry, Elizabeth. Next slide, please. Oh, next slide, please. I apologize. Thank you. Uh, under section 104B of the Consumer Product Safety Improvement Act, the commission is required to issue consumer product safety standards for durable infant or toddler products using the notice and comment procedure in the Administrative Procedure Act. Section 104B2 of 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 in the Finbin decision, the commission not only has the authority to regulate durable infant or toddler products for which no voluntary standard exists, it is required to do so by section 104B2's express statutory command to regulate all categories of durable infant or toddler products. Next slide, please. Because there is no existing voluntary standard addressing the suffocation and asphyxiation hazards associated with infant support cushions, the commission is not required to develop a rule with reference to an existing voluntary standard. Per the requirements of the APA, the draft notice of proposed rulemaking initiates a notice and comment process for developing a rule. Thank you. And now I will turn it back to Stephanie. Thank you, Elizabeth. This project really, next slide, please. This project really began as an examination of the infant pillow ban. In 1992, pursuant to the Commission's Authority under the Federal Hazardous Substances Act, the FHSA, the commission banned infant cushions and infant pillows that have all the following characteristics. Has a flexible fabric covering. It's loosely filled with granular material and is easy flattened. It's capable of conforming to the body or face of an infant and is intended or promoted for the use by children under one year of age. The ban was intended to address a specific type of product, an infant beanbag cushion that was popular in the 80s and was used as a mattress during a time when they recommended sleep position for infants with face down prone. Next slide, please. Over the years since the ban, there have been significant increases in products promoted as infant support cushions that do not fall under the scope of the infant pillow ban, particularly due to the use of the non-granular fill materials. As staff becomes concerned about and staff has become concerned about potential suffocation hazards, these products present to infants. The draft proposed rule would apply to any infant product that is marketed, designed, or intended to support an infant's weight or any portion of an infant by reclining or an asapine prone or recombinant position. All the products shown in this slide would fall under the scope of the proposed rule. And as you can see, there are a variety of products that fall under the scope of the proposed rule. Next slide, please. Along with the significant increase in products in recent years, there has also been an increase in deaths associated with infant support cushions, which has been a great concern of staff. Next slide, please. Dash search of the Consumer Product Safety Risk Management System and National Electronic Injury Surveillance System Databases identified 79 fatal incidents that were associated with infant support cushions and involved infants up to 12 months of age. Nearly all the reported fatalities involved infants six months older or younger, and over three quarters involved infants three months older and younger. And nearly two-thirds of all fatal incidents, the cause of death was determined to be asphyxia-related. At about 40 percent of the fatal incidents, the infant support cushion was placed in an infant product such as a bassinet, crib, or play yard. And nearly half the fatal incidents, the bed, the infant support cushion was placed in an adult bed on a couch or a futon and a toddler bed or on an air mattress. And five percent of the fatal incidents, the infant support cushion was placed on the floor or a mat. And finally, in five percent of the fatal incidents, the placement of the infant support cushion was undetermined or unknown. Next slide, please. The major hazard patterns identified with staff and the analysis of the fatal incidents were the following. The use of the infant support cushion as an in-bed sleeper to facilitate bed sharing, placement of the infant and our movement of the infant within the infant support cushion resulting in inclusion of the nose and mouth remaining in the product, and the infant rolling off the infant support cushion into a hazardous setting. Next slide, please. Although reported fatalities are stashed primary concern, staff also searched for non-fatal incidents associated with infant support cushions to identify other possible risk of injury. Staff identified 125 non-fatal incidents and consumer concerns associated with infant support cushions. About a quarter of the non-fatal incidents were due to falls from the infant support cushion that was placed on an elevated surface such as an adult bed, bath and kitchen counters, chairs and couches. Another quarter of these incidents were the result of the infant being found in a vulnerable position and rescued for a potentially asphyxiating environment. Fourteen of the non-fatal incidents reported a rash while using the infant support cushion and there was one report each for limb entrapment, mole, choking, near strangulation and vomiting. A majority of the non-fatal incidents 38% were consumer concerns. Based on this incident data, staff identified falls and threatened asphyxia as two major non-fatal hazards associated with infant support cushions. Next slide, please. Currently, there are no published voluntary standards for infant support cushions. In December 2021, staff requested ASEM to form a working group under F-15 to develop a voluntary standard containing performance requirements to register risk of death and injury from hazards associated with infant support cushions. ASEM forwarded two subcommittees under F-15. F-15.16 for infant feeding supports, which the commission has already briefed on earlier this year, and F-15.21 infant loungers. At the May 2023 F-15.2 of subcommittee meeting, a draft of the infant lounger standard was discussed, but so far a draft of the standard has not been validated. CPSC staff has been actively participating in task groups for infant loungers that cover the scope, warnings, data analysis, and performance requirements. In August of this year, CPSC sent a letter to the performance task group to present our ideas on slide height requirements that were considered in the ASEM draft lounger standard. Next slide, please. The scope of the draft ASEM lounger standard includes less products that are covered by the scope of this infant support cushion rule. ASEM describes loungers as products with a raised perimeter, a recess, or other area that is intended to be placed on the floor and provide a place for the infant to sit, lie, recline, or rest while supervised by an adult. They are not intended or marketed for sleep. Currently, the ASEM draft proposed rule for loungers includes requirements for side height, stability, infant restraints, occupant support surface firmness, sidewall firmness, and marketing labeling instructional literature. To be clear, the ASEM standard for loungers, which focuses on less products than the proposed rule for infant support cushions, is still in draft form and has not been completed the full census process to be an approved standard. Therefore, the draft language is subject to change. Next slide, please. Staff considered the scope and definition of the proposed rule based on the existing filiband, the infant support cushion market, and incident data. The draft proposed rule defines the infant support cushion as the infant product that is filled with or comprised of resilient material such as foam, fibrous fatting, or granular material, or with a gel, liquid, or gas, and which is marketed, designed, or intended to support an infant's weight, or any portion of infant while reclining, or in a sub-hine, prone, or incognito position. This includes what is not limited to infant positioners, nursing products used for lounging, infant loungers, and infant props for cushions used to support an infant. This does not include products regulated by other CPSC-durable infant and toddler product standards. Next slide, please. The fast proposed rule for infant support cushions includes general requirements found in standards for similar products such as a draft ASEM lounger standard, and the nursing pillow proposed rule presents the commission in September of this year. The infant support cushion rule includes requirements for lead in paints, small parts, hazardous sharp edges or points, resistance to collapse, scissoring, shearing, and pinching, protective components, toy accessories, and a permanency of labels and warnings, which is consistent with the nursing pillow proposed rule, and that includes an additional warning permanency requirement that would address free hanging labels for the important warnings are not easily torn off. Next slide, please. In the proposed rule, staff is requiring firmness requirements for the occupant support surface, sidewall, and the intersection of the occupant support firmness and the sidewall. These requirements are adapted from the CPSC contract report and uses a three-inch hemispheric probe that was developed by the contractor. CPSC staff determined that the dimensions of the three-inch hemispheric hemispherical probe developed by the contractor are consistent with the size and shape of an infant's head. In addition, it can be easily applied to different types and sizes of surface areas that could be present in the variety of products that fall out of the scope of this rule. For the occupant support surface firmness requirement, staff recommends applying the probe to an area of maximum thickness at another location most likely to fail. At these locations, the probe is used to displace and is displaced in the vertical direction their product surface by one inch. The force that is needed to displace the one inch must be greater than 10 newtons. This displacement force is comparable to the displacement force required for crib mattresses. For the sidewall firmness and the intersection of the sidewall and occupant support surface, the same test method is used that is applied to these different locations. Essentially, it is the attention of these requirements that any surface that an infant could potentially come in contact with while using the infant support cushion should be firm as a crib mattress. Next slide, please. Okay. This video that I'm about to show shows how staff applies the probe to the occupant support surface of the infant support cushion. Please play the video. Using the three-inch hemispherical probe, staff will lower the probe onto the occupant support surface one inch and measure the force. Thank you. Next slide, please. Both the infant sleep product rule and the draft ASDM Lounder standard have a maximum incline angle requirement to reduce the potential for assistional xixia hazards. And these rules, the maximum incline angle of the product's occupant support surface can now exceed 10 degrees when measured using a hinge weight gauge. Based on the incident data, staff determined that it was appropriate for infant support cushions to have a maximum incline angle requirement. However, due to the variety of products that fall under the scope of the infant support cushion rule, staff has developed a few modifications to the maximum incline angle test. The most significant modification is what surfaces are considered when determining the maximum incline angle. The infant support cushion and the infant support cushion rule, the maximum incline angle test is measured from the highest surface that can support an infant, including sides to the lowest surface that could support an infant, including the floor or the surface that the product is placed on. Next slide, please. The following video shows staff conducting the maximum incline angle test for two different infant support cushions. The first video shows a product that has a maximum incline angle greater than 10 degrees when measured from the occupant support surface to the highest surface of the product. Please start this video on the left. Staff positions the hinge weight gauge within the product so the top edge of the head torso portion of the gauge coincide with the plumb line the outermost edge of the highest surface of the product and the lower portion of the gauge rests on the occupant support surface. Then staff places a digital protractor with an accuracy plus minus one degree on the angle head torso portion and measures the angle as so. Since this product has a maximum incline angle greater than 10 degrees between the occupant support surface and the highest surface, there was no need to test the maximum incline angle from the surface the product was placed on to another surface on the product. The next video shows a different product where due to the product size it was necessary to measure the maximum incline angle from the support surface the product was placed on to the highest surface of the product. Please start the video on the right. The edge head torso portion of the hinge gauge was positioned on the highest surface of the product and the lower portion of the hinge gauge was placed on the surface supporting the product. The staff then places the digital protractor on the angle head torso portion and measures the angle as so. The maximum incline of this incline angle this product was from the supporting surface to the highest surface was less than 10 degrees. Next slide please. Due to the geometry of the newborn hinge gauge and the methodology of measuring the maximum incline angle the height measured from the lowest surface to the highest surface for the infant support for the infant support cushion will be limited to two inches or less. Interestingly as staff was developing the test for the method for the maximum incline angle test and measuring the incline angles of a range of different infant support cushion products staff observed that products that passed the maximum incline angle test had the having the inclines less than 10 degrees were less likely to appear to contain the infant and compared to products that fail the maximum incline angle test by having angles greater than 10 degrees those products appear to be more likely to contain the infant. Next slide please. To address potential entrapment hazards at the intersection of the sidewall and the occupant support surface staff recommends a sidewall angle requirement that uses the hemispheric probe to determine the angle of this interface which would be greater than 90 degrees. Staff has also included in this proposed rule requirements for restraints, same strength, removal of components and bounded openings. Next slide please. The infant support cushion draft proposed rule includes warning label and instruction instructional requirements. These requirements have been developed based on incident data and recommendations issued from the American Academy of Pediatrics, the FDA and CPSC. The American Academy of Pediatrics, the FDA and CPSC have consistently worn against the use of pillows and soft bedding in an infant sleep environment and urged consumers to only use these products on the floor and stayed near the infant while in use. The warning labels are also required to be conspicuous and permanent. Next slide please. There are more than 2,000 suppliers of infant support cushions to the U.S. market. Most are small businesses. The draft proposed rule is expected to have a significant impact on substantial number of small entities because currently there are no mandatory or voluntary reform and standards for infant support cushions. Also the proposed requirements would be new and most likely require redesign for any small business in the market. Therefore, staff recommend recommends an effective date of 180 days. Next slide please. But based on what I presented here, the staff proposed staff recommendation to publish a notice of proposed rulemaking, the staff draft proposed rule for infant support cushions with an effective date of 180 days following the publication of the final rule. Thank you and I welcome your questions at this time. Thank you. At this point in time we're going to turn to questions from the commissioners. Once again, thank you as well as your teams for continuing to focus on improving the safety of infant products. They are the most vulnerable among us and really need to be a priority for the agency. So I appreciate all of your works and all of those behind you as well. Given the staff's concern about infant support cushions being used for sleep and being present in sleep environments, and as you mentioned, started with the pillow band. Why did the staff propose a performance standard at this point in time? What's the thinking behind the approach? It's staff's termination that the most effective and fastest way to address the hazards associated with infant support cushions was to go the 104 rule route. This allowed us to develop a strong and broad rule that supported our findings from the infant data review. Also, consumers find infant support cushions helpful for allowing their infants to relax for brief periods of time. And the four requirements that we developed for the rule address the hazards that we saw with the infant data. So a cushion meeting this standard would in effect be a less hazardous place to put infants on while still being useful to parents? Yes, that's correct. I may have other questions, but I'd like to hear from my colleagues. I'm going to start with Commissioner Feldman. Okay. Thank you, Mr. Chairman and Dr. Marcus and Ms. Leighton. Thank you very much for your work on this proposal and for the presentation today. I appreciate it. I have a number of questions. I'm hoping to get to as many of them as I can in this, but if we go over, I may want to request a second round. But to start off, we're a data-based agency and I'm taking a look at the incident data that you guys provided primarily on Slides 8 and 9. On Slide 8, staff lists, 79 fatal incidents that we're aware of. Are we relying on all of these incidents for proposed rule? A significant proportion of the fatalities that were listed appear to be attributed to something other than suffocation or asphyxia, which I understand is the hazard that this proposed rule would seek to prevent. Another significant portion of these fatalities appear to involve other hazardous settings beyond the infant cushion itself. And I would presume that a number of these incidents would involve co-sleeping or proximity to blankets, toys, other items that aren't recommended for a safe sleep environment. So is staff relying on these 79 ideas as the basis for the recommendation for its determination or is it discounting some of the 79? I would say we relied on the 79 incidents. The three major hazard patterns that we outlined that facilitate bed sharing with movement within the infant support cushion and the movement out of the infant support cushion to a hazardous setting, that's all indicated in the incidents and all the incidents that show that were considered when developing those hazard patterns. Those hazard patterns are what we directly try to address with the performance requirements and I think that the staff concluded that the performance requirements do address those hazard patterns on the incident. On page 10 you wrote that 40 of the slide deck you wrote that 47 percent of the non-fatal incidents were due to consumer concerns. I don't know what that means. Can you explain what you mean by consumer concerns? Sometimes it will be the consumer will write in or report to us that they said the product, they thought maybe they saw a recall product and they have the recall. I'm sorry. Sometimes the consumer will report that they have seen a recall and they will report that they have a recall product, they don't know what to do or they think that the product, they weren't sure how to use the product. They're just basically concerned that consumers will write in reports to us that don't really or not really have any injuries but just mostly based on. And we're counting those as incidents? We're counting those as consumer reports. As a consumer it's an incident report. But that was in the non-fatal incident and we didn't consider that with the developing the hazard patterns or the with the two hazard patterns that were discovered in the non-fatal incidents or the threatenants fixed again in the falls. And none of the consumer concerns really addressed those issues. I understand. On sidewall height we know that almost 20 percent of the incidents here involve that hazard pattern that you discussed where an infant rolled off the product into a hazardous setting be it toe sleeping or you know within a crib or a bass net or something like that. Yet what I understand staff is proposing is a limit on the sidewall height that presumably could be justified by for example discouraging caregivers from believing that these products are safe for unintended infants. Are there any human factor data that we're relying on or other information that staff is relying on to suggest that a lower sidewall height would actually discourage caregivers in this way and if not do we run the risk of exacerbating both the the roll-off into a more hazardous environment pattern as well as the risk of fall. The sidewall height is something that we're open to comments on. We discovered we concluded that the sidewall height that maximum incline angle which we're really concerned about is just an auspicious incidence limited the sidewall height or the potential sidewall height to two inches and as I said we observed with those those products that the sidewall height did not give the impression or that the products could be contained in the infant. This is one of the major hazard patterns that we've seen with the data is that this issue that consumers see to have the impression that these products can contain the infant and we we concluded that that does contribute to a lot of the hazards associated with the infant support questions. Okay in that conclusion I guess is what I'm asking about is that supported by human factors or any other data that that sidewall height has any sort of positive relationship with that conclusion or the belief by parents and caregivers that that the products in factor are safe for unintended infants or is that just a supposition that we're making? I would have to ask my team member from human factors to more to give you a better answer on that but my understanding is that when we discuss sidewall height and we're going through the issues that there is no clear literature or data on the impression the sidewall height and the impression that contained with consumers. Okay it looks like you've got council. Celestine's ready to go. I'm Celestine Kish from the Division of Human Factors and it was more a matter of the comments we received about consumers using the product because they with the larger sidewalls because they had the sidewalls they the consumers were saying my baby fit in there and could stay in there so then the lower sidewalls they won't have that same impression. Okay okay that's helpful thank you thank you for that. On the maximum incline angle of 10 degrees that seems to be one of the key features of the proposal here how did staff come up with the recommendation of 10 degrees as the maximum incline angle is that based on the for example the the University of Arkansas 2019 study that we've relied on elsewhere or is that from something else? It's based on other rules for the maximum incline angle for infant for the infancy product rule that's so that we're it's the the 10 degrees that we're relying on here is based on the the 10 degrees that we used in the the ISR if I understand correctly that ISR was was based on the the 2019 man in study so so that's the the the underlying study and research that we would be relying on for the 10 degrees here. Yes okay on the test probe staff's draft proposal includes an occupant support for firmness test and obviously a test in the sidewall and you explain that and thank you for that but it involved the a test probe and a method that I understand were developed by the researchers at BSU I just want to get a better sense of what that test would look like should CPSC move to finalize the rule and whether BSU or any of the study authors own patents or other IP in either the probe itself or the test method and if so whether staffs received assurances that that that the any relevant IP holders would would license that to labs and others at on sort of fair and reasonable terms um that I'm I'm not aware of and maybe someone more a cable it would be able to answer I don't think that'd be you've got co-counsel that they did not describe you have Mr. Bonapas the test probe is uh in apparatus are the same ones we're using in other rules and that there are no uh uh there are uh there are a variety of uh probes that can be used to meet the requirements okay apparatus itself is uh is already out in uh in use and what about the method is is that something that would be sort of freely accessible to to anybody that would want to use that method to test yes among other things we we sponsored that research so it's uh paid for by the government okay great um I I do have additional questions but I don't I want to be mindful of the time thank you very much I appreciate that the responses Mr. Helms can Mr. Trump thank you thank you for the presentation and thank you for everyone and all of you here in the room they contributed to this rule this is fantastic I mean this is a really fantastic proposal you look at this problem logically you hit it from every angle yet you approached it thoroughly and as Miss Kish came up and reminded us you know we have experts and we lend expertise and we we rely on statistical analysis and we can also use common sense sometimes and and you did all of those in in this instance so thank you um as we look into the death data you know I I see that we've identified 79 incidents since 2010 and what I'm you know kind of most fixated on right now is that 40 percent of those are in just the last two years for which we have data so in 20 and we've got 17 deaths in 2020 we have at least 17 deaths in 2021 and you've indicated that number could grow as more data comes in so this looks like a growing trend and that's concerning and that's why I'm glad we're here talking about it today um so my question is when we look at those and when we look at the potential solution that you've proposed what percentage of these do you think we can prevent if this if this rule goes into effect the hope is that all of them um but um we we think that the performance requirements that we developed in this rule address it's it's it's all based on the incident review and we are we're very determined to make sure that all the hazards that we identified through the incident review were addressed in these performance requirements so it would be the goal that all of them would be addressed um you know I thought that was going to be the answer when I read this package I'm so happy to hear it I know we don't like to speak in absolutes but but to know that that's the goal and and it was clear when I read this package that's the goal so yes again thank you um you know so so you indicated a lot of these deaths are happening on soft surfaces when these when these products are placed on a bed or on a couch or or any other soft surface and the only other question I had is on the testing so on the occupant support surface firmness testing um which seemed great by the way I like the number test points we're using on that as well um but the question is the the sample size that we looked at only one seemed to pass that and it had a thin fabric based you know it was less than an inch you can understand why it would test when it was placed on a firm flat surface have we given consideration to the fact that these might not always be used on those firm flat surfaces and testing on maybe a soft surface would it would it perform the same that test on a softer surface I guess there would would be differences we had have not put that in the the proposal we're open to comments on that but um I know the testing to be done is usually on a support surface yeah um but that's something that would definitely be something to the comments on and testing labs they use all these products might be used okay yeah I mean that might be one where it's a little bit difficult to define the soft surface we put it on but but if we think through that issue and we realize that that's going to be the scenario that's the hazard scenario in real life if we can forget a way to account for it that might be great but again I mean I'm nitpicking at this point because this rule is fantastic in terms of this proposal you've put forward so thank you thank you can mr. wall thank you mr. chair and thank you dr. marquez for this work and for all the other staff members so I know I've been working on this quite some time I do appreciate it very much just to go back to the discussion of the 40 percent of the fatalities in 2020 and 2021 to what do you attribute that spike if if you know um the increase in the recent years I honestly don't know how to respond to that there has been an increase and the deaths that in the recent years um I think these products are more out in the market and I think that um the just the I'm really not sure how to answer that question I'm sorry okay that's okay we may not know but it is remarkable to see that happening yes okay I appreciate that again sticking with the data for a minute I think 80 percent of the fatalities associated with the products involve infants three months and younger is that correct yes okay are you aware of any of and that's consistent I think with what we heard recently on rockers where a large percent of the incidents were involved in that age cohort is there any commentary you would share on literature or infant development that you would suggest explains why there's a cluster of incidents in that age group that age group seems to be the most vulnerable age group as far as in sleep environments especially because the net age group between the two and six months age range infants often can find themselves they can they can do movements such as flipping over but not be able just to be able to go back and that is the age where they are able to do certain things and not be able to self-rescue as easily they don't have the motor skills to self-rescue if they find themselves and inadvertently it's flipped over to bring it for the first time and then they can't do it back and then they find themselves in a hazardous environment that's also when their their head to body ratio is heaviest and so they tend to have heavier heads to lead them to more face-down situations given that have you given thought to a specific warning for that age cohort on these products or any of the type of products that we would talk about in the under the 104 Rupert? Well I I we're open to comments on that too I think that the the age the intended age range for the products can be under one year so the the warnings would be would be kind of restricted to that age range at least that one-year range range right further yes right but I took what you're saying what the data seems to be suggesting that even with you know there's a broad range in that zero to 12 and that maybe we're really even focusing more on that zero to three zero to four that is something we could consider you know comments on and consider yeah saying you know in that same vein in terms of warnings I think in the os on page os 104 the health sciences memo it states that premature infants and infants who are born as a set of multiples are particularly vulnerable and are at the highest risk primarily due to physical inability and immature physiological system again I know we we believe put warnings in the proposed rule and rockers for this cohort and I wonder if you thought about that in this instance we have not thought about it put it in the the proposed rule as it stands now but we definitely will and something to consider in the future and comments on yes okay thank you sorry okay thank you I appreciate that very much and just one last question and I know you talked about it in your slides but could you please explain again the difference between the as how astm defines infant lounger and how we're defining it in the proposed rule um so yeah astm they basically find the infant lounger as a product with a raised perimeter they and a recess or other area that's intended to be placed on the floor and place a place for the infant to sit lie recline or rest while supervised by an adult so our product rule basically our rule basically says it's a product that's filled with the fibrous batting or resilient material that has been intended to support the infant during periods of to reply to the wide accompaniment recline prone or supine so it the big difference is the idea of the I think the raised perimeter that the loungers incorporates in their definition versus our definition for infant support questions we're seeing and it's just as they're supporting they don't have the the perimeter issue okay clear thank you I appreciate that I don't have any more questions Mr. Chair thank you again very much there has been a request for a second round so Commissioner Feldman okay thank you Mr. Chairman I'll try to be brief following up on a the question that that my colleague Commissioner Boyle asked with respect to that 2020 to 2021 spike that we saw which based on the the the the the histogram that you put forward I think told the story where it was almost a a doubling but you mentioned that that that it may have to do with the number of products in the marketplace has staff been able to normalize the incident data based on into control for the number of products in the marketplace and if so is that trend that that we saw it is that possessed um I don't think that we've done that I mean I have to get back to you for it okay if we could I think that that would be useful um with respect to durable products this this light and this is probably a question for you staff is proposing that we proceed with the rule under section 104 which applies as we all know to durable infant and nursery products can you please explain how staff is defining durable in this context and I'm not looking for a legal interpretation oh okay um as as explained in the notice these products are considered durable because they're often used for more than one infant um more than one child uh either later children the same families that initially purchased the product or sometimes they're sold on the secondary market as used products um so for those reasons they so they can be used for several years okay so the the the definition here is sort of limited to products that can be resold or reused uh not saying I don't I don't want to get into I'm not saying that's the limit of the definition but I'm saying that's an indication that staff has pointed to uh to reflect the durability okay because we do see a number of things that can be resold uh and reused including clothing that I don't think that we uh would consider um to be durable per se but but that's not the only indicia that we're looking at I know and I if if uh the commissioner would like to get into a discussion of the legal definition of durability that would need to be in a closed session okay uh on product substitution thank you thank you uh on product substitution so to the extent that the proposed rule would render a significant portion of these products uh useless and that staff predicts that a number of firms would exit the marketplace all together uh what if anything do we anticipate in terms of user substitution here this is an issue that's been raised in the context of other infant and toddler products that we've dealt with recently do we expect parents and caregivers to substitute with products that that are known uh to be safer or can we rule out regrettable substitutions like blankets and pillows and and things like that that may in fact be less safe um well the the the intention that um that these products that they'll be still be able to use these products and just in a safer way they'll be safer um products that present less hazards just those um that are more firm and they're less able to contain the infant um I I'm not sure how to answer the question um yeah so I I think it's safe to say that we cannot rule out regrettable substitution parents are going to do a variety of different things I think as Dr. Marquez notes what we're looking to try to do is for these products that are marketed for infant use for relaxation and so forth we're trying to make them safer so the hope the intent is to ensure that they are in fact safe for those advertised purposes okay with respect to the substitution issue writ large this is something that human factors has studied and will it share its findings on the record I think we'll have to get back to you I don't know that it's explored in this package but we'll look back to see if there's other materials okay I'd appreciate that thank you um last question I think um so I do understand that uh uh and you got into this when with the discussion of uh uh the small business impact but I do understand that a significant portion of the producers in this marketplace um fall into the category not just of small businesses but but are more of the sort of home crafters and in DIY hobbyist portion of that particular market um should the commission finalize this rule uh will it apply to these home-based businesses and if so can you discuss a little bit about how the commission attends intends to address this segment of the marketplace um our economists can address that yes uh good morning um so the market is largely uh there are a lot of home crafters um selling and um as stated in the our IRFA we do expect that'll be a significant significant impact to them uh but we want to receive comments on exactly how it would impact them as you as as there's a lot of home crafters it's a very opaque market so we're asking for comments for more information about exactly how it would it would impact them okay um when it comes to the testing requirements that we're awarding what we're putting in place are we aware of test labs that that work with home-based businesses and sort of cater to uh these sort of specialty small batch DIY producers that can help with that I think we actually crossed that Rubicon uh with the um infant sling carries rule where we had that that same sort of uh uh working with the micro producers and them having to then start work with the labs so I think that they're more familiar with that process than uh than in the past okay I'm glad you're that we're we're asking comments for this I think that there is some opacity here that that uh makes sense and in addition to understanding the impact on on this segment of small businesses uh obviously it also poses uh I would posit some some very serious enforcement challenges um just given how diffused that market is but uh I think those are exactly the types of things that that that I in particular would would look forward to hearing comments on so again I thank you all for answering the questions and for your work not only on the presentation today uh but the the package and the proposal itself so thank you very much Mr. Trumka thank you um you got some questions on substitution here and and I think the way I look at it when we look at the death numbers in this product this is the regrettable substitute for a safe sleep space and you're making this safer so I don't think that's the thing we need to worry about here uh and as we continue to clear the various segments of other unsafe sleep surfaces I mean that's the goal uh and and get people back in cribs bass and that's from flat surfaces is the goal so getting rid of these regrettable substitutes is what you're talking about today thank you Mr. Wall I don't have any additional questions just to thank you again for your work I appreciate it and I add my thanks as well um for both the informant briefing and for the work that you've been doing in you know over the past years on this um and also to thanks to the commissioners for the active participation and thanks to the office of secretary as well as facilities communications for their assistance in this briefing um there's not been a request for a closed session so with that we are adjourned