 So good morning, everyone. Welcome to this public meeting of the United States Consumer Product Safety Commission. We have two items on the agenda this morning. We have a decisional matter on whether to accredit the laboratory of Guangxiang M&P Manufacturing Company Limited Conformity Assessment Body as a firewall third party laboratory. That's a mouthful. Also, we must decide whether to authorize the deputy executive director for safety operations to grant or deny subsequent applications. Peter, it looks like you wanted to say something. No, please. Okay. The second thing is that we have a decisional matter on whether to approve staff's recommendation to finalize a rule established in a safety standard for infant sleep products under section 104 of the Consumer Product Safety Improvement Act of 2008. And that meeting will follow this, but we've scheduled it for 10 o'clock, so we will begin that at 10 o'clock. So with respect to the firewall lab issue, a word of background. Section 14 of the Consumer Product Safety Improvement Act, which was enacted in 2008, requires third party testing for products subject to CPSC children's product safety rules and certification that such products comply with our rules. And if you look to section 14 F2D and CPSC rules, they provide the CPSC may accredit conformity assessment bodies, also known as labs, that are owned, managed or controlled by a manufacturer or private labeler if certain conditions are met and briefly stated they are. That the lab must be accredited by an international body like ILAC, as I call it, that's the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement, that the applicant has established procedures to ensure that its test results are protected from undue influence by the manufacturer, private labeler or any interested party, any other interested party, excuse me. The Consumer Product Safety Commission must be notified immediately of any attempt by the manufacturer, private labeler or other interested party to hide or exert undue influence over the test results and allegations of undue influence must be reported and maybe reported confidentially to the CPSC. And in view of all of these findings, then the accreditation of the lab must provide equal or greater consumer safety protection than use of an independent third party lab. And as I understand it, staff recommends accrediting Guangxiang M&P Manufacturing Company Limited to do testing for six CPSC standards, which mainly have to do with compliance with our lead standards. We have several staff members present in the event. There are questions in the opening round. And let me just enumerate those who are here. Mary Boyle, CPSC Executive Director, Dwayne Ray, CPSC Deputy Assistant Executive Director, Dwayne Boniface, the Director of EXHR, Jen Sultan, our Acting General Counsel, and of course, Alberta Mills, our Director of the Office of the Secretary. In addition, David D. Mateo from the Office of General Counsel and Scott Hay from EXHR are here and I assume both are here because I heard David's voice. We'll begin with questions for the staff if there are any, but let me remind you that this is a decisional meeting, not a briefing. So I'm hopeful that there'll be few, if any, questions at this point since we've all had an opportunity to ask questions previous to this meeting. But we will give commissioners five minutes for questions. Once the questions are complete, I'm going to move two votes. First on whether to approve the accreditation of the lab and then a vote on whether to delegate the authority for the Deputy Executive Director for Safety Operations to grant or deny future applications. Once again, I want to remind everyone that while it is perfectly appropriate to voice our personal opinions on legal issues, we can say I interpret the law this way or that way. It is not appropriate to discuss legal advice given us by the Office of General Counsel. Legal advice must remain confidential. And so now we will move to a round of questions and I will begin by having no questions. Commissioner Kay, do you have any questions? I do not. Thank you, Mr. Chairman. Thank you so much. Commissioner Bliacco, do you have any questions? Dana, can you hear me? Because I can't hear you. She's taking her head. No, she has no questions. Commissioner Feldman, do you have questions? I do have some questions, Bob. Thank you. So first, I want to acknowledge at the top, I appreciate everyone's hard work on this matter. CPSC has an important role with respect to third party labs that we have crowded. And particularly when it comes to making sure that there's no undue influence in those cases where the lab is owned and controlled by the manufacturer itself. And as was described in the briefing package, this is a matter that we're talking about today where the lab is owned by the manufacturer that wants to conduct testing by creating a firewall between the lab and the parent company. And what we're talking about today is a lab that we conduct testing for lead in toys, among other things. And let me be quite clear, lead in toys is still a big deal. Staff regularly sees these kinds of violations with the type of products that we see for children's use. And in my view, that warrants the highest level of scrutiny. And with that in mind, what we're being asked to pass judgment on today is the extent to which the lab will protect its results from undue influence, the extent to which CPSC is going to be immediately notified when there's any attempt to exert undue influence, and the extent to which whistleblowers can come forward and confidentially report those incidents to CPSC. And if there's anything that we've learned over the past year, it's that not all countries share our value with respect to openness and transparency and whistleblower protection. China in particular presents real dangers and challenges with respect to safeguarding its laboratories. We're still learning more about the origins of COVID-19. And it's fair to say that there's a growing consensus about the lack of Chinese transparency with respect to its laboratories. And these issues are increasingly top of mind. So CPSC periodically approves these sorts of accreditation. I'm concerned that this has largely become an exercise in rubber stamping the applications that we receive. I think it's important that we have these conversations in public. And if there are additional things that the Commission could be doing, I want to make sure that we're exercising the appropriate oversight. So with that in mind, I do want to ask a few questions both about the diligence that we've taken with respect to reviewing the application from the accrediting body and staff process here. So I don't know who would this would be best directed to, but is it correct that the entire process of lab approval is via the examination of documents? Or in this process, do we have CPSC staff undertake any sort of onsite visit either virtually or in person? Hi, this is Scott. Hey, can you hear me? Yes, Scott, please go ahead. Yes, it is. It is a document review, a very detailed review of the laboratories policies regarding undue influence and their policy to all staff that it must be reported to the commission and maybe done so confidentially. And then we review all the training records for the laboratory staff on those, on those records, but it is a document review. If we're not, thank you. If we're not doing in person review, what about the accreditation body itself? Are they doing in person inspections? And if so, how often? Yes, as part of the ILAC process and the ISO standards, all accredited labs must periodically renew their accreditation. So depending on the accreditation body, that can be two or three years. And they will have insight visits by those accreditation bodies to make sure that they are following all the requirements in ISO 17 025, that the lab is technically competent, that they have all the management procedures in place. And then of course, every, every two years, the CPSC requires labs, every lab, including firewall labs to submit an audit application with us, which is essentially a renewal application where they submit all of their documents again to make sure that they're accredited to the technical standards they're accredited to and to make sure that they'll have those undue influence policies and training in place. How are we ensuring that the lab staff can actually report allegations confidentially to CPSC from a lab in another country that already faces allegations of restricting free speech? I certainly, we are relying on the, what the lab tells us and the documents that the lab provides, short of that reliance, as said at the beginning, we don't do in-person checks on that sort of thing. Okay, so without revealing any case specific details, can you tell us, tell us if there's instances of approved labs being subject to whistleblower complaints, and if so, how were they resolved? I hesitate to discuss if we've done any investigations on whistleblower complaints that sort of merges into compliance matters, although if we get them, we have procedures in place to follow up and start an investigation. Okay, that's fair. Bob, I still have more questions. I see that I'm over the five-minute mark. Do I have five minutes or 10 minutes for questions during a decision? We said five minutes. I don't have any further questions. I would ask you, I hadn't seen the questions you were raising and I don't know whether staff saw them in advance, but I think that would have been helpful if you'd shared them, but please go ahead and just keep in mind. Because I'm happy to yield for a second round if anybody else has a question. I think you are the second round, so please proceed. I appreciate that. So in the staff presentation, specifically on page four, it was noted that staff reviewed documents that explained how the lab will protect the test results from undue influence. Scott or David, can you provide some additional details on how these assurances work operationally? I guess I'll talk to that point. We look for a controlled operational procedure by the laboratory that basically states the policy that the lab will not allow undue influence and must very clearly state those major elements as outlined in the CPSA. About any allegations of undue influence the laboratory staff feel subjected to must be reported to the CPSC. Here's the contact information for the CPSC. Assuming a lab states that, how do we ensure that those protections are maintained over time? Is there any sort of periodic CPSC review or review by the accreditation body? Those CPSC specific requirements on reporting undue influence to the CPSC may or may not fall under the review process of the accreditation body. But it's something that we review at a minimum every two years to make sure the processes haven't changed and make sure their training is up to date. Lastly, I realize that our regulations allow for paper submissions. But in the instance of foreign laboratories that are seeking approval, how do we ensure that the test lab's independence is going to be maintained and that whistleblowers are able to communicate with the CPSC without fear of retaliation? We're truly just taking the requester's word for it. My short answer to that I guess is yes and that would be the same no matter what country the lab is operating in. Okay. I think this is an issue that we need to continue to take a look at and I don't know whether this involves revisiting the regulations that we have on the books or going to Congress to seek some additional regulation. But I would also note that staff has requested here authorization to grant or deny subsequent applications by this laboratory as they've done with every firewall lab request that I've been asked to vote on since I arrived at CPSC. I'm going to continue to vote to deny this subsequent delegation. I think we need to review these requests with a fresh eye so that we don't bind future commissions with respect to the decisions that we're making here today. With that, I appreciate Scott and David answering questions. That's all I have for now. Thanks so much staff for answering the questions. I'm going to now move to approve staff's recommendation that we accredit the laboratory of Guangxiang M&P Manufacturing Company Limited as a firewall third party laboratory in accordance with the order attached to the staff briefing package of April 21, 2021. Is there a second? I second it. Thank you so much. And I now seek to entertain any amendments to the motion that commissioners may propose if there are any such amendments. Commissioner Kay, do you have any amendments? I do not. Thank you. Commissioner Biako, do you have any amendments? I do not. Commissioner Feldman, do you have any amendments? No, I do not. Okay. Then that said, we will move to consider the recommendation from staff to accredit this company as a firewall lab. Commissioner Kay, how do you vote? I vote aye. Commissioner Biako, how do you vote? Yes. Commissioner Feldman, how do you vote? I vote yes. And I vote yes. The votes are four to nothing. The first motion is approved. I now move to the second motion and that is to approve the delegation of authority to the deputy executive director for safety operations to grant or deny future applications by this lab for additional requirements or test methods. Is there a second to that motion? I second it. Thank you so much. And now I will entertain any amendments to the motion that any commissioners may have. Commissioner Kay, any amendments? None. Thank you. Commissioner Biako, any amendments? No, thank you. Commissioner Feldman, any amendments? No. Okay. And I have no amendments. We now, I will now move the question. Commissioner Kay, how do you vote on this second motion? I vote aye. Commissioner Biako, how do you vote? No. And Commissioner Feldman? I vote no. And I vote aye. So it looks like it's a two to two. So the amendment, the second amendment, the second motion is not adopted. And so we'll have to move to come up with some additional approaches to delegation to staff. I think that is this for the vote on firewall labs. As a matter of formality, we have up to 10 minutes for any commissioner to make closing remarks. I of course, invite everybody to be brief. I have no closing comments at this point. I may issue a statement, but I have no closing comments. Commissioner Kay, do you have any closing comments? I just want to thank Mr. Hay and the rest of the staff for their continuing work on this matter, but nothing else. Okay. Thank you so much. Commissioner Biako, any closing remarks? I don't. And I think the staff as well. Okay. And Commissioner Feldman, any closing remarks? I don't. I appreciate the staff's work on this. And I'm glad that we were able to have this conversation in public today. Thank you. Okay. Thank you so much. And I want to join in thanking the staff. It's always a delight to be able to answer questions when you're being, when they're being thrown at you and I thought you did a great job, Scott. So what I want to announce is that we will be moving to consideration of the infant sleep product vote, but that will be taking place at 10 o'clock since we had alerted the public that that's when that discussion would take place. So we will now be in recess mode until 10 o'clock. Good morning, everyone. We're turning to consideration of the final draft rule to establish a consumer product safety standard for infants products. As I said at our briefing two weeks ago, this draft rule arises under 104 consumer product safety improvement act, also known as the Danny Kaiser child product safety. Or colloquially as Danny's law. This act honors Danny's child who died in an infant product that had been the subject of two calls, but the product somehow remained on the market and led to his demise. Pursuant to section 104 of the infant sleep products draft rule, if finalized will incorporate by reference the voluntary standard ASTM F3118-17A as a mandatory standard with modifications to make the standard more stringent to further reduce the risk of injury associated with infant sleep products. To do that, the draft standard addresses infant sleep products, that is products that are intended to provide sleeping accommodations for infants that are not currently covered by existing rules for things like bassinets and cradles, full size and non full size cribs, play yards and bedside sleepers. The rule builds upon and expands a current voluntary standard, which I've already mentioned, it expands the voluntary standard to require that first the seat back angle intended for sleep must be equal to or less than 10 degrees. And secondly, the infant sleep product must meet the requirements of the bassinet and cradle standard at 16 CFR part 1218. In addition, the draft rule does two other things that we can't ignore. It amends the commission's regulation regarding third party conformity assessment bodies to include the infant sleep product standard in the list of notices of requirements issued by the commission. And it requires manufacturers of infant sleep products to provide consumers with prepaid consumer registration forms to be kept unfiled by the manufacturers and that's routine whenever we write a child safety standard. Getting to this point has prevented presented staff with a number of challenges as new data have reserved has served this regarding the hazards of infant sleep products, eventually leading in 2019 to the abandonment of a more narrow standard which was just addressing inclined sleep products and the subsequent expansion of the standard to include all infant sleep products including inclined and flat products. So to repeat the draft final rule now defines infant sleep products as those marketed or intended to provide sleeping accommodations for an infant five months old or younger that are not already subject to one of five existing CPSC sleep standards. In the past couple of weeks we've received a number of emails from concerned members of the public regarding our consideration of this rule, including yesterday we got a submission with some 30,000 signatures in support of the But let me repeat what I said at our briefing, the official comment period for submitting comments close some time ago, but it's long been the practice of the agency to docket even last minute submissions. Although staff can't formally comment on them the way they do with more timely filed comments. But first of all I want to thank everyone who submitted comments pro and con regarding today's vote. Alas, we don't have the resources to contact each and every one of you who submitted comments but I assure you that your comments will be considered. So let me describe how the session will proceed today. We're going to begin begin with questions for staff, if there are any I again remind you that this is a decisional meeting and not a briefing we had a briefing two weeks ago so I'm anticipating few if any questions at this point, since we've all had the opportunity to raise questions. That said, each commissioner will have five minutes for questions. And let me also read or reiterate who the staff members are. In addition to those who have been previously introduced. So today, we have Dwayne Ponefus who is the director of ex HR, Celestine kish project manager infant sleep products from the division of human factors and the director for engineering sciences, and Mary house and attorney in the regulatory affairs division of the office of the general council. So let me make one final point before we turn to questions for staff. This is a public meeting, and because staff legal advice should be provided in a confidential setting. I'm going to reiterate that any questions or comments that involve staff legal advice should not be discussed in an open meeting. I suspect that some of the points of discussion today may well involve legal issues which again any commissioners free to express is or her personal interpretation of the law, but not to put on the record staff legal advice. And just to reiterate this point if acting general counsel Jen Sultan is there could you reiterate the rules of the road for discussion about legal issues. And good morning to you miss salt. Good morning everyone as commissioner acting commissioner Adler just stated, I just would like to remind all of the commissioners today to please refrain from discussing legal advice at the office of the general council has provided to you in this public setting. And as needed, I may appear to help remind you of that. Thank you everyone. Thank you so much and we'll now turn to questions for the staff. And I didn't really have any questions but I did I guess want to ask one question and that is, we've seen a lot of comments about bed sharing and about the fact that this will remove the dead sleepers from the market. And the argument has been raised that this will work to the detriment of low income and disadvantaged consumers. And I wonder if staff wanted to respond to that and make clear that you're not the cold heartless folks that you might have been painted to be so Celestine if you wanted to respond to that or if Dwayne Boniface if you wanted to respond, please feel free. Turn my camera on. There we go. Okay, good morning. As staff said in the briefing. It is our intention to make sleeping environment safe for infants. And that is why the staff has presented the recommendations to comply with one of the five sleep regulations already available. For those who are interested in bed sharing, we certainly encourage the use of a bedside sleeper because it does provide the opportunity for the child to be right next to the parents in their own space. And that is that is why the staff prepared the package the way we can. So I thank you for that. And I have no further questions. Commissioner Kay, do you have any questions? I do briefly. Thank you, Mr. Chairman. Miss Kish, is there anything at this juncture that is preventing the ASTM process from continuing to move forward to develop standards for any of these products? No, not at all. In fact, the 104 rule allows ASTM to present any new and updated standards that they would like the commission to consider as they move forward. So in any of the work that they're doing with the bassinet standards or the in bed standards, if they're able to complete and update a standard, the commission will certainly consider it. And so if this rule is adopted, there's a one year effective date, correct? That is what staff is recommending. Yes. And so it's at least theoretically possible that ASTM could meet every day if it wanted to and develop a standard for any of the products that might fall within the scope of this rule and then present to the commission an updated standard that would address that product. That is possible, right? That is possible. Yes. Okay. I have no other questions. Thank you, Mr. Chairman. Thank you so much, Commissioner Biacco. Any questions? I do. And first, let me address, Bob, your comment. No one thinks any staff member is cold-hearted. And I hope that asking questions does not imply that we are cold-hearted because I can tell you this. I have struggled with this rule probably more than anything else I've worked on at the commission. I understand the basis for the rule. I understand why we need the rule. But I still have some concerns, and I've been talking about them last night, this morning, and up until now, and I do have a few questions. So Ms. Kish, can you just confirm for me that this mandatory standard, if it's adopted, will apply to any product for sleep, regardless if it was originally intended or designed to be a bassinet? The way the staff has presented the intent is for any designated sleep product, that does not already comply. I think you're going to have to mute it now. She's answering the question. So any sleep product that does not already comply with the five sleep regulations that we have, so cribs, bassinets, bedside sleepers, play yards, if that product is intended for infant sleep, for infant five months or up to five months, it must comply with the bassinet standard. Okay. And I think it was you during the staff briefing who told me that if it doesn't fit, if a product that's on the market doesn't fit in, it needs to be redesigned, right, or it can't be sold. Correct. It may have to be redesigned in order to meet the bassinet standard. Okay. Can you identify, sorry. Can you identify for me, I don't know if this is for you, Ms. Kish, or anybody else, can you identify for me what products will be forced into a redesign or forced off the market. I mean, I'm still doing my own research because I can't seem to get an answer on this. Can you help me with this? So the most of the in bed sleepers that are currently on the market would have to redesign in some way to meet the bassinet standards, and that means they may have to provide a stand. They may have to change the height of their sides of their product. Those are the biggest issues with some of the compact smaller in bed sleepers. I think that's the easiest way to shift to discuss that. Can you give me an idea of how many products that applies to? I do not know that answer. I'm not sure if Susan proper from economics would be able to answer that for you. Is Susan available? Sure. So that would be dozens of products in the in bed sleeper category, and also dozens of products in the various bassinets do not have legs or a stand some of the soft sided travel bassinets. These go up by a lot of different names, but basically things that are called bassinets but do not in fact meet the bassinet standard at this time. Okay, so those dozens of products, aren't they a different class of products that should have their own voluntary standard? Well, I know that ASTM is actually working to develop a voluntary standard for in bed sleepers. ASTM has gone back and forth quite a bit with whether in bed sleepers should be part of the bassinet standard or not. They were considered originally in the compact bassinet discussions that the bassinet group is working on. But then that a couple years ago they decided to branch off and be their own voluntary standard, but ASTM has not developed the standard yet. Can anyone tell me whether or not we considered any sleep or well-being specialists with a background in occupational therapy or that had expertise in in bed sleepers as part of this package? So I'm not sure if anyone with that background is part of the ASTM process, but they are certainly welcome to be part of the process and we have had on ASTM calls a number of representatives from hospitals and other groups that work with the underserved area, but I don't know their background. You know, I'm sorry, Ms. Kish, I think it's because of my sound, I'm being muted and unmuted. So you may have missed a part of the question. What I was trying to find out is not with regard to the ASTM, but with regard to this package, have we considered any expertise or heard from anyone with a background in bed sharing products as part of our package? Well, we have gotten comments from the SMPR. We did receive comments from consumers about the in bed sleepers. Again, I don't know the background of all the people specifically to your issue. Okay. For now, that's all I have. Thank you very much. Thank you so much. Commissioner Feldman, your questions. Thank you, Bob. I have no questions, but I'm happy to yield the balance of my five minutes that Commissioner Bianco, if she has additional questions. I don't think it's questions that I have at this point. Okay. I have no further questions. And Commissioner Kay, do you have any further questions? I do not. Thank you, Mr. Chairman. Okay. Well, back to Commissioner Bianco, if you have further questions or comments within the five minute period that's just been granted to you, please feel free. I'm muted. I have comments, Mr. Chairman, but I don't think I have any additional questions that that make a difference at this point. Thank you so much. Then hearing no further questions, I'm going to now move the adoption of the staff draft final rule on infant sleep products. Is there a second? I second it. Thank you so much. Now, at this point. Before we get to the, before we get to the underlying question, I do have a motion. Is that in order? Peter, it's more than an order. I was about to address that. So if you'll just give me a second, I will address your point. I was about to say, normally I would discuss this motion and have it discussed and deliberated, but you, Commissioner Feldman have circulated a possible motion for our consideration and having consulted with the general council. I've been told that your motion would supersede my motion so that it is now appropriate to turn to you for your motion. So please. Thank you. And first, let me say thank you to staff who I know have been working on this issue. In particular, an infant sleep for years. I know how much work goes into an effort like this. So I do appreciate everybody's hard work. Second, I don't think I'm taking any liberties when I say that every one of us, all of the commissioners share the goal here of protecting infants. And I also want to say to the many parents who reached out to me, I hear you. I read and appreciate your comments. And this is part of the process of doing rulemaking like this in the open is having an opportunity to petition an agency like ours for redress and to make sure that you've been heard and you have been. I am concerned, however, that if we issue the rule today, as it stands, it's implementation. Would you make your motion and let's see if there's a second and go on and explain it? I have been a motion that I'm offering that's on the table that the commission would direct staff to resubmit the final rule package as a second SNPR to collect comments on the underlying justification for including the flat infant sleep products in the rulemaking and to submit a revised final rule to the commission for an up or down vote. Thank you for that motion. Is there a second to Commissioner Feldman's motion? I second it. Thank you, Peter. I'm sorry to interrupt. Did you please continue with what you were saying? As I was saying, I'm concerned that if we issue the rule today as it stands, its implementation may be delayed or even frozen as a result of procedural deficiencies that were pointed out in response to the 2019 SNPR. We received comments that pointed to a number of deficiencies in the final rule, including data issues, notice efficiency, and the fact that CPSC wasn't entirely clear that flat products were to be included in our most recent SNPR. So, let alone the final rule, the motion that I'm offering today would hit the pause button and allow staff to address some of the issues by collecting additional comments on the underlying justification, among other things, including the flat sleep products in the rulemaking. I think that such an approach would strengthen the commission's position on a final rule and would provide a process that's fair to all that are involved and sufficiency under our statute. I believe that it's a more prudent path to mitigate the risk so that our final rule will stand here. And in my view, providing a second round of notice and comment, which would allow staff to conduct with all deliberate speed an opportunity to mitigate the risk that commenters have raised regarding judicial scrutiny here. The language of the motion, as I said, would direct staff to resubmit a final rule package as a second SNPR to engage in a second round of notice and comment rulemaking and then to resubmit a final rule for commission consideration. I would welcome any questions and on the fly edits that my colleagues would have, but I thank you all for considering it and that is my motion. Thank you so much. At this point, we will now have a five minute round of questions or comments on Commissioner Feldman's motion and I will begin. And let me say, Peter, I strongly dispute the notion that there are any procedural deficiencies identified in the SNPR and I strongly oppose your motion because I don't think it's legally necessary. I think it promotes the worst kind of paralysis by analysis, and I think it sets a terrible precedent for rulemaking under section 104. And let me remind you, we all voted to issue the SNPR and I don't see anything of significance in the final rule that wasn't mentioned and explained in the SNPR. And I disagree with the notion that we didn't make clear that products that were flat products would be considered. I'm looking at a language from the Federal Register notice, and it's specifically addressed when staff was questioning whether there should be further study of sleepers with inclined greater than 10 degrees and they said it's not necessary and I'm quoting because staff concludes that a flat FLAT, my added notion, surface that does not exceed 10 degrees offers the safest sleep environment for infants. We discussed that this was going to address flat products. I think there was no question about that. And let me say that somebody who has followed CPSC rulemaking over the years, rulemaking under section seven and nine of the CPSA is about as swift as a herd of turtles stampeding through a vat of peanut butter and you've heard me say that before. And one of the reasons that Congress placed section 104 under the procedures of 553 rulemaking of the Administrative Procedure Act was to expedite and streamline the protection of young children, which this delay would greatly undermine. And I fear Commissioner Feldman is set up a self fulfilling prophecy should there be a court challenge to this rule. If you have a commissioner who's duly sworn to carry out the mission of the agency and that person is voicing misgivings about the rule. It makes it doubly hard to argue that the commission wrote a rule in a perfectly appropriate and legal manner. I can only hope that any reviewing court will understand that our dedicated and knowledgeable and skilled staff spent years carefully drafting and refining this rule. It's thoroughly justified and documented in accordance with the law. So, frankly, I shudder at what I have read in some of the letters to the Commission from those who've lost or children or those who know children who've been lost in sleeper accidents. I note they all strongly support this rule. And I also note that there are incredible number of groups that are dedicated to protecting children, including the American Academy of Pediatrics. Public citizen, consumer reports, kids in danger all strongly support this rule. And so I'm going to oppose Commissioner Feldman's motion. Commissioner Kate, do you have any comments or questions? Bob, I disagree with you in terms of the law. It's a federal dodge that's going to have to decide which one of us will come back. Excuse me, you are out of order. We will come back and you will be able to respond. Right now I'm turning to Commissioner Kate. Thank you, Mr. Chairman. Just in brief, I will not support this motion. I think it's well past time to address this critical safety gap that has existed, unfortunately, for too long. And so I oppose Commissioner Feldman's motion. Thank you. Thank you very much. Commissioner Biacco, any comments that you care to make at this point? Well, I could talk about this all day, frankly. I'm struggling with Commissioner Feldman's motion in several ways, but I see validity in Commissioner Feldman's motion in several other ways. I disagree with you. I do think there's a procedural challenge, a good one, frankly, and I'm disappointed that we've been unwilling to go back and fix that. But that's not my bigger concern. I want to see this rule move forward. I don't want to see it stall. So from that perspective, I struggle with sending the whole package back. In fact, you all know that I've raised this issue before that we should let go forward and carve out these flat products and look at them from a standard and safer point of view. But I couldn't get support for that. I will also say that I've spoken to tons of people, and you're right, we've gotten lots of letters and so forth. But it was the most passionate advocates yesterday that actually convinced me that maybe we shouldn't go forward with this rule. I asked them yesterday to give me a list of products that they considered bad. They gave me two, if you want to call it that. One was a company name, and they really didn't describe what was wrong with the product. And the second product they identified for me was a product not even on the market in the United States. So I kept asking, I have not been able to get it. So I struggle with, I agree with everybody that part of this rule that applied to inclined sleepers, which is how it all started, should go forward. But if this is where we are, I do not have enough information to take a group of products that you guys are describing as flat off the market. And that is exactly what will happen with this rule, as we just heard from my questions. And what really I struggle with is that all we hear about is flat is best, bear is best. And if you don't have a bassinet, and you don't, you have to redesign it, we're taking flat products, which I'm also being sold as best off the market, and I have a real problem with that. So if my only choice is to support commissioners motion, as it's presented all supported but I, I'm, I think we should have fixed this and I don't think there's any reason why we couldn't have held a public forum and had this information and maybe just satisfy our point of view so I'm torn here too but if I have to go one or the other I'm going to support the motion. Thank you so much, Commissioner Bianco, Commissioner Feldman, you can feel free to respond now. You're muted, Peter. My response is that you and I clearly disagree on the law, but but ultimately it's the DC circuit that's going to make a decision here about which one of us is right. Are there additional comments or questions to be raised with respect to Commissioner Feldman's motion. If not, I will now put to a vote, Commissioner Feldman's motion. Commissioner Kaye, how do you vote? I vote no. Commissioner Bianco, how do you vote? I'm going to go yes. Okay, and Commissioner Feldman, how do you vote? I vote yes. And I vote no. Commissioner Feldman's motion is not carried. And so I will now return to consideration of my motion. And if I might take a few minutes to explain it. So as a starting point, I want to join all of my fellow commissioners in thanking CPSC staff for an incredibly comprehensive and detailed analysis of the reasons for moving beyond the original NPR published in 2017 to adjust for new data and to provide further expert analysis that led to the November 2019 publication of a supplemental notice and proposed rulemaking. While in the SNPR, staff became aware of 451 incidents that occurred from 2005 through June 2019, including many that were not known until after the 2017 NPR. And with respect to this further injury data, staff carefully analyzed it to identify the pattern of incidents that produced the risks from these products and to address them. However, staff contracted with a world-renowned mechanical engineer with a biomechanics specialization, Dr. Aaron Manon, to conduct infant testing to evaluate the design of inclined sleep products. After careful and thorough testing, Dr. Manon concluded that a 20 degree incline in an infant sleeper put infants at risk for muscle fatigue and suffocation. By her testing, she had concluded that 10 degrees was an appropriate amount level to set. I think staff's approach is elegant, simple and effective to solve the problem of infant sleep products. I would say that, Commissioner Biakko, I hear your comments. I think those are policy arguments and those are the arguments that we've hatched out. I don't see them as going to the heart of legal justification for the rule. I think there's no question, but that ample notice and an opportunity for comment was provided in the SNPR. I'll just turn again to the fact that when I look at groups like the American Academy of Pediatrics, Kids in Danger, Consumer Reports, Public Citizen, and our CPSC staff, they all argue that the best approach is flat sleepers that are best placed outside of a bed. We certainly are free to listen to any additional ASTM amendments, and so that is my explanation. Commissioner Kay, I turn to you for any comments or questions you have about the motion on the table. I don't have any, I'll hold any statements I have till after the vote. Thank you, Mr. Chairman. Okay, thank you so much. Commissioner Biakko, any questions or comments? Thank you, Bob. We can agree to disagree. I'll adopt your moniker here, but I think we are exactly trying to decide on a policy, and that is exactly what's going on here. And as part of that policy, there are some legal issues. And as I mentioned, I think there are legal issues, but that's not what's bothering me the most, as I've already said, so I don't want to repeat myself again. Thank you so much. Commissioner Feldman, any comments you wish to make about the motion on the table? I have no comments at this time. Thank you. Okay. And the motion is on the table. I now ask whether there are any amendments to the motion. Commissioner Kay, do you have any amendments? I do not. Excuse me. What's the motion? The motion is to approve the staff recommendation that the commission published the final rule on infant products. Commissioner Biakko, do you have any amendments to the motion? I don't. Okay. Commissioner Feldman. No. Thank you. Okay. Then having deliberated on the motion, I now move the question. They shall the commission approve the staff recommendation that the commission published the final rule on infant products. Commissioner Kay, how do you vote? I vote aye. Commissioner Biakko, how do you vote? Well, I'm not ready to vote yet. Can you just get me for a minute? Yes, I can. Commissioner Feldman, how do you vote? I vote yes. And I vote yes. So commissioner Biakko, we can certainly give you a moment to consider your vote. But I do ask that you issue it in a timely fashion, if possible. So here's, let me say this. I am prepared to vote to support the rule generally, but I am struggling with the overreaching and the overly broad and late notice and the impact the rule will have on flat infant sleep products. Most of which are and can be used in a variety of applications, including but not limited to bed sharing. I've asked staff as recently as yesterday. I've asked staff today, as I mentioned, I had a conversation yesterday with with very passionate advocates who had a lot of great things to say. But I just think that this rule is intended to apply to it just goes too far. So I'm going to vote for the staff to take other action and that is to advance the rule as it was intended to apply to inclined sleep products, but to carve out and have a hearing and do a deeper dive into the products that I've been told by pretty much everybody I've asked can have a standard in and of itself and that's what I that's that's my vote. Okay, thank you so much. So final is three in support of the rule one to take other action. They rule is adopted. We now move to closing remarks and each commissioner will have up to 10 minutes for closing remarks. I invite you to be brief with respect to closing remarks, and I have made most of my closing remarks. I didn't want to say that this is a proud moment I think for the commission. And it's certainly one of my proudest moments as a commissioner. What we've done today fulfills the most sacred of our obligations is committed to take steps to protect vulnerable consumers, including and especially baby. I note that what we're protecting them from is not something that's malevolent or nefarious in fact we're protecting babies from the most loving and well intentioned of acts. When a loving parent or caregiver puts a baby into a product that is intended or marketed for sleep. This vote ensures that when a product is intended or marketed for asleep, it will be safe for an infant to sleep in that means a flat surface not an incline that can put a baby at risk from suffocational or positional asphyxiation. Let me congratulate agency staff in particular Celestine. You've worked so hard for so long to bring this rule to fruition. It's one of the strongest most protective rules I've seen in all my years at CPSC. I also want to thank the many advocates on both sides who pushed us to reach this point today. I particularly want to thank those parents who've turned their personal tragedies into advocacy that has been extraordinarily effective. Today's success belongs to agency staff to the commission and to you and your families and all the babies who will sleep more safely from now on. I can now turn to Commissioner Kaye for any closing remarks that he has. Thank you, Mr. Chairman. In 2008, Congress passed the Consumer Product Safety Improvement Act, which overhauled the agency, but probably the most important part of that act was Section 104. It really was a landmark provision that changed not only the rulemaking procedures for certain products, but really the culture of safety around how we regulate them. And even though I haven't always agreed with how the process has worked or the timing of the process, I think we can all agree that it has vastly simplified and accelerated as Congress intended the way we oversee these products and the rules that we write. However, despite all of that, there was this one major gap that had persisted and that was sleep products, certain sleep products. Even though we had addressed cribs and bassinets and other products that had remained the safety gap, and more importantly, parents had a gap in their misunderstanding of what was happening for those products or to those products before they came on the market and when they came on the market and whether they were subject to any kind of performance standards. They were not, and that was a problem. And today we took a major step to rectifying that problem. I would have loved for it to have happened sooner, but this is just the way things go. There's a lot of work that goes into these things. Staff has worked extremely hard at the AFTM level with a lot of different parties. Staff has also worked on their own to write and develop this rule. They deserve a tremendous amount of credit for their persistence from our Executive Director Mary Boyle on down. And we're really grateful for all that they did. Even with all of that though, there is no reason for the AFTM process not to continue to go forward as we covered during the opening of this session. For anybody whose product will be subject to this rule and the effective date goes into effect, they still have time to work every day if they wanted AFTM, and I'm sure the staff will participate, to try to write an updated standard to cover those products, to address the hazards sufficiently, and to create the space that they think they need it to have their own standard. And I'm sure that the Commission will support those efforts and we would look very closely at any resulting standard that came out of that process. So I would encourage the parties to do that if that's something that they're interested in. But in the meantime, as the Chairman said, I think that this is a historic day for the safety of infants. I'm proud of it. It's probably the last one or four that I will vote on during my time at the Commission. And it's going to be the most meaningful one for sure. Thank you, Mr. Chairman. Thank you so much, Commissioner Kay, Commissioner Villaco closing remarks, please. So, you know, it's interesting to hear Commissioner Kay and some of the other comments about, you know, we encourage these other participants to keep working out with AFTM and come up with the standard. That's what's bothering me and why we would ever subject an important rule like this to a legitimate challenge I don't know. This rule is not intended to apply to bed sharing without a product. I think everybody agrees with that. I think the advocates told me that yesterday, but stated differently. It does apply to bed sharing products. I'm also told that the people, the groups that support this rule the most believe that loungers are perfectly safe, that flat infant sleep products can be made safe, and that we should have a standard. And I agree with all of that. So my question here today is, so why don't we? Why are we doing this backwards? Why are we lumping in a bunch of products that we have no data or no support for and to muddy up a rule that should have gone a long time ago and is important? I've asked the staff to hold a public forum on this to no avail. I've asked my colleagues to join me in carving out these undefined products, which I still to this day, I'm not sure which products they cover, although I'm hearing today dozens. And I don't know why we can't come up with a voluntary standard for that class of products. Because everybody agrees that it can be done and we're talking about it and why we couldn't have held and gotten more information to confirm that there is data and rationale to support scooping them into this rule as was set forth in the SNPR. I just, I'm struggling with that. I haven't heard from one single person who's an expert in these products, and I think that's a huge deficiency. And it does subject the rule to challenge, which I don't want to see happen. And I'll tell you to be candid, I am terrified that this adopting this overly broad rule, we will leave parents in a situation where they're going to babies will be put into an even more unsafe situation. And I think we all have been very, we have been hyper focused on what we all think is best based on what our lives are and the circles and lifestyle in which we all travel, but I think we have ignored or did not fully research and take into account other aspects. And as everybody has said, we've gotten, I've gotten more emails and letters and petitions on this particular world and any other since I've been at the CPSC. But I got one last night, late last night, that I'm going to read a portion of it to you because I think it sums up where I am. A woman wrote to me and said, my belief is that bed sharing families are amongst the largest, most underserved population in the US. I am a sleep and well being specialist with a background as an occupational therapist, and I have had the unique opportunity to interact with bed sharing families on a daily basis. We are everywhere, yet we are really ignored and excluded from conversations at best. And at worst we are demonized, fear mongered and called horrible names. And I'm not going to read the whole email and pick out two other things I want you to hear. Believing the lie that bed sharing is never safe or a valid option and not receiving education about bed sharing put my baby drastically more in more unsafe situations than she has ever been while safely bed sharing. She lists literature, information, one by Professor James McKenna, which is the first time I've been exposed to that. And she sums up saying this, regardless of a specific individual's views on bed sharing products like post sleepers and loungers, and whether they should or should not be used for bed sharing. It's important to keep the discussion open in order to allow for more specific standards and regulations for these products, if that is needed, rather than just shutting the door to future conversation and development of these products. If CPSC moves forward, it will only cultivate more shame and silence, along with a black market of products. And I am very concerned. And I think this particular person sums up exactly how I feel that we should have these things open for more discussion. We should have looked at them and we should not be putting people in a situation where they make their own bed sharing apparatuses that could very well put babies at even more risk. I'm terrified of that particular position. And with that, I will stop. Thank you so much, Commissioner Feldman, your closing remarks. Thank you. So today I joined my colleagues to finalize in a bipartisan manner this rule to protect children. And we all share the goal of protecting infants. Nevertheless, during this process, commenters raised a number of procedural issues, as well as substantive concerns about the unintended consequences here. And Commissioner Biaco just put that forward quite eloquently. While I have some misgivings, the safety benefit of the final rule, in my view, outweighs the risks given what we know now. But I expect and I'm asking that staff closely monitor the implementation of the rule and the potential for these unintended consequences, particularly with regard to co-sleeping. The CPSC, among other things, is a risk reduction in mitigation agency. Yet today we're pushing ahead despite knowing about the potential legal challenges that could be addressed on the front end of the rulemaking. While I voted yes on the final rule and in the strong interest of protecting children, I would have much rather my amendment had been adopted. We could have tried to get this right the first time. I fear that legal challenge, which could take years to resolve, and will end up likely costing the agency more time and resources than we have to spare and resulting in less protections for the infants while this is sorted out. So with that, I'll reserve the rest of my comments for a later time. Thank you so much. Thank all the staff for the extraordinarily hard work they put in and for the professionalism they've shown. And with that, I now call this meeting over and close the meeting. So thank you all again.