 Hi, and welcome to the U.S. Consumer Product Safety Commission's webinar on infant sleep products, inclined sleepers for infants, and crib bumpers. My name is Chris Nguyen, and I am a program specialist on CPSC Small Business Ombudsman Team. Please note that the presentation was prepared by CPSC staff and may not necessarily reflect the views of the Commission. Products shown are only for demonstration purposes and do not constitute endorsement. Today we will start off with the discussion of the infant sleep products rule, how we define it, the purpose, the factors taken into consideration for scope determinations, and some frequently asked questions. I will then go over the Safe Sleep for Babies Act, which involves some of the same products that are included in the infant sleep products rule, but are specific towards inclined sleepers for infants and crib bumpers. I will also go over the differences between the infant sleep products rule and Safe Sleep for Babies Act, and then go over a few frequently asked questions for inclined sleepers for infants and crib bumpers. After that overview, I will go over product registration form requirements, as well as children's product certificate requirements. We get a lot of questions on both of these requirements, so I want to spend some time talking about them today. I'll conclude the presentation by presenting some recall examples and end with an overview of CPSC business resources, as well as how to get in touch with the small business ombudsman team directly, if you have any questions. The infant sleep products rule, which I will refer to as the ISP rule, has been codified under 16 CFR Part 1236. The big takeaway for the ISP rule is that any products that meet the definition of an infant sleep product and are not already covered by another standard must comply with 16 CFR Part 1218, the safety standard for bassinets and cradles. One of the requirements is that sleep surface angles must be 10 degrees or lower. The rule is in effect now and applies to products manufactured on or after June 23, 2022. Any products manufactured before the state are not subject to these mandatory requirements. What is the purpose of this rule and what is it intended to address? It's intended to address deaths and incidents associated with infant sleep hazards, including, but not limited to, fall hazards, asphyxiation and suffocation, obstruction of the nose and mouth by bedding, and inclined sleep surfaces. I will spend more time going over inclined sleep surfaces later, both with the Safe Sleep for Babies Act, as well as in some of our recall examples, so that we can illustrate why these rules and requirements are so important to help safeguard infants and children from potentially dangerous products. How are these products defined? What products are included in this scope? These are products that are marketed or intended to provide a sleeping accommodation for an infant up to five months of age. So if we're talking about sleep products intended for children over five months of age, like a six month plus or a one year plus product, it's likely out of scope of these requirements. It's also for products that are not already subject to one of CPSC's existing regulations for infant sleep. 16 CFR part 12-18 for bassinets and cradles, 16 CFR part 12-19 for full-size baby cribs, 16 CFR part 12-20 for non-full-size baby cribs, 16 CFR part 12-21 for play yards, and 16 CFR part 12-22 for bedside sleepers. In other words, if your product is already subject to one of these requirements, it's not subject to the ISP rule. As a reminder, products that are in scope of the ISP rule would have to comply with the bassinets and cradles standard under 16 CFR part 12-18. Examples of infant sleep products include baby loungers marketed or intended to provide a sleeping accommodation, baby boxes, in bed sleepers, baby nests and pods, rigid sided and rigid framed compact bassinets without a stand or legs, as bassinets are required to be elevated and not directly on the ground, as required by the bassinets and cradles rule, various designs of traveled bassinets with soft padded or mesh sides, and baby tents. When we're talking about scope determinations and thinking about what types of products are subject here, what is our thought process? What factors are we taking into consideration? CPSC looks at the marketing, advertising, labeling, and packaging materials to get a sense of the manufacturer, importer's intent. That's a really important piece. How does the manufacturer or importer intend the product to be used, viewed, and understood? What is the intrinsic nature or design of the product? How is it engineered? How would the product be used based on purely its design without that marketing piece? With the foreseeable consumer use or misuse of the product, a lot of times people forget to think about the misuse scenarios, and that's such a critical and important piece of the product design stage. When thinking about foreseeable misuse, a scenario to consider is whether the product can be installed incorrectly. For example, before the curb standard was in place in 2011, there was a drop side curb that I'm aware of in which an unfortunate death and tragedy involving an infant occurred. The only thing that happened that went wrong is that the consumers accidentally put the drop side on backwards. The product was designed in a way that enabled it to be installed in that way. The tragedy could have been prevented if the product was designed in a way to prevent such a misuse scenario. Another thing to be mindful of is that simply renaming or relabeling a product for non-sleep use will not likely provide a basis to avoid the ISP rule. If it was previously intended or marketed for sleep, removing the references to sleep are likely not enough to make it out of scope of the ISP rule. A couple more thoughts here on scope of determination. When we're looking at how to understand products in this category, we're thinking about products with certain types of themes such as sleeping, snoozing, dreaming, or napping. There could be a situation where, as a manufacturer, you didn't intend for the product to be an infant's sleep product, but if you're using these types of themes in your product, that might send mixed signals to the consumer. Like if you're showing this cute bear sleeping, then caregivers may believe it is a safe place to put their baby down to sleep when that wasn't necessarily your intent. Even subtle design choices like this can make a huge difference in how a product is perceived and understood and how consumers are viewing your product. Let's get into a few frequently asked questions about the ISP rule. Can I sell a product that was previously marketed for sleep but does not currently meet any of the existing CPSC sleep standards if I re-marketed and re-labeled the product as not for infant sleep? We touched on this question briefly, but that's a super common question that I want to highlight again here. As we just went over, the commission will consider the factor set forth in the ISP rule that include but are not limited to marketing and advertising, labeling, product design, and consumer usage. If the product's main function was for infant sleep based on the product's design, they cannot simply be re-labeled as not intended for infant sleep to avoid meeting the requirements. If the product's main feature was for infant sleep, it is incredibly difficult to change consumer perception of the product's usage. To keep vulnerable infants safe, it's best to ensure that your product complies with the requirements rather than to try and re-market your product to avoid compliance. Will a combination diaper bag with the changing pad or travel bassinet need to meet the ISP rule? This is another common question that we've received. If the products are marketed or intended as bassinet or sleeping accommodation for infants up to five months old, they must meet the ISP rule. If the diaper bag has a changing pad that's only marketed or intended as a changing pad and is not marketed as a bassinet, bed, or travel crib, it's likely out of scope of the ISP rule. You should also be mindful of the design features we went over such as themes of sleeping animals. If you plan to include these types of designs in the product, it could be interpreted that these products are intended for infant sleep. So moving on to the Safe Sleep for Babies Act of 2021, which I will refer to as the SSBA. This is an entirely different entity than the ISP rule that we were just talking about. The ISP rule is a performance standard. So that's a standard where you engineer and design a product to come into compliance with that applicable regulation so that can be permitted to be sold. The SSBA is a statutory ban and it was passed by Congress and signed by the President for inclined sleepers for infants and crib bumpers. The effective date of November 12th, 2022, is for products in scope of the ban, regardless of the date of manufacture. This means that any products that are in scope of the ban cannot be sold or distributed into commerce at all, regardless of when it was manufactured. This is a big difference compared to the ISP rule and other rules that are generally passed by the CPSC, which only apply to products manufactured after a given date. The SSBA applies to two classes of products, inclined sleepers for infants and crib bumpers. The ban for inclined sleepers for infants is codified at 16 CFR part 1310. Inclined sleepers for infants are defined as products that have an inclined sleep surface greater than 10 degrees and that are intended, marketed, or designed to provide a sleeping accommodation for an infant up to one year old. This has more expansive coverage than the ISP rule for these particular inclined sleepers for infants as they go up to products for up to one year old. The products shown here would appear to be subject to the ban. It would not be allowed to be sold or distributed at this point, regardless of when they were manufactured. Let's go over a few frequently asked questions for inclined sleepers for infants. How does the ban of inclined sleepers for infants differ from the ISP rule? There are a few key differences, but also a few things that overlap between the SSBA and ISP rule. The SSBA bans all inclined sleepers for infants with an incline of 10 degrees or more that are sold or distributed on or after November 12th, 2022, regardless of the date of manufacture. It also applies to inclined sleepers for infants up to one year old. The ISP rule requires all in-scope products manufactured on or after June 23rd, 2022 to comply with maximum seatback angle and performance requirements and applies to infant sleep products for infants up to five months old. The ISP rule also applies to both inclined and flat sleep products, whereas this portion of the SSBA applies to inclined products only. Some inclined products will be covered by both the SSBA and ISP rule. An example of this would be an inclined sleeper that's intended for infants up to five months and has a seatback angle over 10 degrees. This product would be subject to the SSBA ban, but it would also fail to meet the maximum seatback angle set in the ISP rule. How do I determine if my product has an incline that is subject to the ban? So the SSBA does not provide a specific method for how to measure the seatback or sleep surface angle. CPSC staff recommends measuring the maximum sleep surface along the occupants head to toe axis relative to horizontal using the same test method as in the ISP rule. The ban for crib bumpers is codified at 16 CFR part 1309. Crib bumpers are defined as any material intended to cover the sides of a crib. This includes padded crib bumpers, supported and unsupported vinyl bumper guards, and vertical crib flat covers. The ban excludes non-padded mesh crib liners. So mesh crib liners will still need to comply with all other applicable requirements under CPSC's jurisdiction. If you're not sure how to comply what the requirements are, where to get your product tested, or what the labeling requirements are, these are things that CPSC's small business ombudsman team can do to help you when you reach out to us. All of our contact information can be found at the end of this webinar, and we're happy to help with any questions that you have about CPSC requirements. Are crib rail covers subject to the crib bumper ban? Crib rail covers that are intended to cover only the top rail of a crib and do not cover the crib slats fall out of scope of the crib bumper ban. However, if the crib rail cover extends below the top rail and covers the sides of the crib, the product would need to be evaluated on a case-by-case basis to see if it falls within scope of the ban. If you have any questions about whether your crib rail cover falls in scope of the ban, you can reach out to us and we'd be happy to help you. Are braided crib bumpers, pillows, and empty pillowcases that are designed to attach to the inside of crib slats subject to the crib bumper ban? The answer is yes. These types of products are subject to the crib bumper ban. The product registration form requirement applies to infant or durable products and is basically a card designed to allow consumers to register their products for possible recalls or other safety alerts. It must be a postage paid card and you must also have some type of online mechanism for the consumer to be able to register as well. For consumers that register, you must maintain records of names, addresses, emails, and other contact info. However, you should only use this information to notify consumers of recalls for the product and not for any other type of marketing purposes. The manufacturer name and contact info, model name and number, and data manufacturer must also be permanently placed on the products. If you're a foreign manufacturer or an individual located outside of the United States, it can be a little tricky to understand how to get that business reply mail with the United States Postal Service. If you're struggling to find out how to get the business reply mail going, please get in touch with us and we can help direct you to where to go with USPS. We get a ton of questions about children's product certificates, also known as CPCs. Certificates must accompany each product or shipment of products covered by the same certificate. A copy of the certificate must be furnished to each distributor or retailer over the product and must be made available to the CPSC and US customs upon request. It's not required that you provide this to the ultimate consumer, although you can if you choose to do so. Please note physical copies of your certificate are not required to be included in your shipments. Electronic certificates are acceptable and may be used to satisfy the company and furnish requirements. But the electronic certificates must be created no later than the time of shipment or final distribution within the US. My best recommendation is to watch our short video series on youtube.com slash USPSC. Check out the business education playlist on our YouTube channel and you'll be able to find that video series. You can also view the first part of the series at CPSC.gov slash CPC. Each video in the series is about five to seven minutes in length and there's only three of them. At the end of that 15 minutes you'll have a much better understanding of what you need to do to comply with the certification requirements. One big takeaway is that the manufacturer and importer, whoever the US, the US based party that's responsible in most scenarios is the one that must be creating and issuing this document. In general you don't want the testing lab or some other supplier to do this for you. CPCs are required to have the seven key pieces of information listed on the screen here. We tend to see a lot of confusion about the citation section. That's section two of the CPC. On the screen we have examples of how the citations should be listed. A best practice is to provide the legal citation with a brief description of what that citation is. Admittedly it can be sometimes difficult to figure out what the citation is. So you can reach out to us and we'd be happy to help you identify the correct citations for your products. Now let's go over a few recall examples. Although this product on screen was issued prior to the implementation of the ISP rule and SSBA, we wanted to provide a few examples of recalls that illustrate the hazards associated with inclined sleep products. Here you can see a recall that was originally issued in 2019 and was reissued again in 2023 because we're still seeing deaths that occurred after the recall. For these products the fatalities occurred after the infants rolled from their backs to their stomachs or sighed while unrestrained or under other circumstances. Here's another product that was again recalled in 2019 and reissued in 2023 because we identified additional deaths after the recall which is unfortunate. It's possible that these consumers were not aware of the recall. That's something to consider as well when issuing a recall. You want to put enough notice and attention on the recall to help consumers become aware to stop using these products and participate in the recall. Here's an example of a baby lounger that was recalled in 2023 due to failing to meet the ISP rule. The recall notes that the failures include not having a stand and not meeting the requirements for side height and fabric-sided openings. The product sides are shorter than the minimum side height limit. The sleeping pads thickness exceeds the maximum limit and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped. Although there were no incidents or injuries reported with this product the goal here is to comply with these product safety rules to prevent these types of hazards from occurring. Here's an example of a recalled baby hammock swing that meets the definition of an inclined sleeper for infants under the SSBA. The product was marketed for infant sleep and has an incline angle greater than 10 degrees. Although this is called a baby hammock swing the intended use in marketing is key in helping to determine whether the product falls in scope of the ISP rule or the SSBA. In this case since it was marketed for infant sleep and has an incline angle over 10 degrees it was considered in violation of the SSBA. Here's another example of an infant swing product that violates the SSBA. The product was also marketed for infant sleep and has an incline angle greater than 10 degrees. The recall also notes that the product violates the safety standard for infant swings. It's important to note that although the product falls into a different existing class of products in this case infant swings it can still be subject to the SSBA based on the product's intended use in marketing. This brings us to the conclusion of our webinar. If you have any questions you can contact us in a few different ways. You can send us an email at SBO at CPSC.gov. You can give our business line a call at 301-504-7945 or use our online contact form at CPSC.gov slash SBO contact. I also highly recommend that you sign up for our business education newsletter. We send one or two emails a month that combines all of the new CPSC regulatory or statutory activity that's occurring. You'll get updates from us directly through this listserv and we'll also see training opportunities listed, videos we put out, and other helpful information. You can also visit our business education playlist on CPSC's YouTube channel at youtube.com slash US CPSC. You can also visit CPSC's regulatory robot tool which is a wonderful resource that you can use to help identify and understand the likely applicable requirements in place for your product. You can go check that out at business.CPSC.gov slash robot. We hope you found this webinar helpful. Thank you so much.