Good morning, and welcome to this public meeting of the United States Consumer Product Safety Commission. Today we will consider one agenda item, the Notice of Proposed Rule Safety Standard for Baby Changing Products. This proposed rule would establish a safety standard for baby changing products under the Danny Ksar Child Product Safety Notification Act, also known as Section 104 of the Consumer Product Safety Improvement Act of 2008. We will, as we always do, start with five minutes of questions for each commissioner to ask of the staff in front of us, and then we will turn to consideration of the proposed rule. Today we are joined by Mr. Mark Kumagai, Director of the Division of Mechanical Engineering in the Directorate for Engineering Sciences in EXHR, and Ms. Meredith Keltch, Attorney in the Office of the General Counsel. And I do want to thank the both of you for the excellent work in this package. It was well-written and easy to digest, which is not always the case for us to be able to do that with some of these topics, so I appreciate the work that you did. I'm going to start with questions. Mr. Kumagai, if you could just give us a brief sense, please, of how the back and forth has gone. And just to set it up, so Section 104 of the CPSIA envisions that the staff consults with a number of groups, and it usually occurs, of course, in the ASTM process with the voluntary standard. And then if the staff is comfortable with the standard as proposed, they move forward. If staff believes it can justify further stridgency in the name of safety, staff proposes that. Can you explain? Because in this case, we do have staff proposing additional items because of hazard patterns and data. Can you explain how that process has worked and where we are in the back and forth, and really when it started, and how you see it carrying through, please? So each ASTM and 104 standard has sort of the same pattern. In changing tables, we started the process, I would say, around May 2015, where we presented the data to ASTM, the incident data. Now, prior to that, we've always been active in all ASTM juvenile product standards. So it's not like we just jumped in. So we have a very good relationship with the entire juvenile products group. So in May 2015, we usually start out with a presentation of the incident data. We have a discussion amongst the ASTM subcommittee and the CPSC staff on what we consider are the incidents, the data, the hazards that need to be addressed. Usually, at that point, the ASTM subcommittee will divide out the problem into task groups. And in this particular case, we had a task group for structural integrity and collapse restraints and warnings. Then once that gets established, the hard part starts, the work starts. And that usually consists of a lot of task group meetings, a lot of back and forth between ASTM task group committee members, and which we are one of them. We will discuss data. We will perform a test and evaluation on products. In this particular case, we would meet over once a month. So we've met during that time since 2015, about 16 times. And my engineer, Shayna Donahue, was very active in developing test requirements to address these issues. And we would go back and forth and try to understand some of the issues that the manufacturers would have with our proposals. And in the end, we would come up with some agreed upon proposals. Now in this case, after this iteration, we had a pretty good base. And we had a few outstanding items that ASTM and the CPSC staff are still working on. At this point, we feel that we had enough development into those requirements to move forward and propose. Thank you for that. And for the three areas where staff is proposing additional changes, at what point do you feel roughly in this process staff alerted the ASTM subcommittees to those changes? Well, we've had ongoing discussion. So early in the process, we were discussing structural integrity, which is one of the largest hazard patterns in changing tables. So I would say a little bit after 2015, the May 2015, we started working that. So the ASTM subcommittee knows that that's an issue that we need to address. And the ASTM subcommittee validated some proposals and we got some negatives. So that's part of the process to work through those issues. And of course, there could be, I'm not suggesting this, but it's also possible that one avenue would be that you would just wait and work through those negatives and then come to the commission. What made you decide or made staff decide that now is the time to propose the NPR? Certainly timing is something that we would consider. At this time, we know the incident data collapses one of the largest hazard patterns. I think our staff, our engineers were very comfortable with what we were proposing. We think we understand the issues. We think that this is a good that we've developed this requirement to a point with the ASTM task group. We've developed this requirement to a point where it's ready for public comment. Excellent. Thank you for that. I fully support what you're doing and I now turn to Commissioner Adler. Thank you very much. And I only have two quick questions. And this, when I was looking at the briefing package, it said that we relied on data from NICE and reports from retailers and manufacturers through what we now call Consumer Product Safety Risk Management System data. Did that include our database? Did we look at our database for injury patterns? I assume we did. It just didn't say it here. Right, that was traditionally the CPR and SSR database. Live and learn, yeah. The other issue that's a little more concerning is that you say the staff found a statistically significant increasing trend in injuries during this 10-year period. Do you have a theory about why it is? Is it a changing demographic? Is it a changing or an expanding use of changing tables or no particular theory, but it's reflected in the data? That was what our statisticians determined. We really didn't spend any time trying to figure out why. We were more focused on how to fix it. Yeah, no, I agree. And for no other reason, that's an argument for not waiting. It's an argument for pressing ahead if we see an upward trend in injuries. I have no further questions. Thank you. Commissioner Robinson. Thank you. And thanks so much, Mr. Kumagai, both for you and your team putting this together and also for the very informative briefing that you did in my office before this hearing today. I just want to make sure that I understand the focus that you have today with respect to the things that are a little bit different than what the voluntary standard is at this point. And as I understand it, you basically, when you're sitting in the ASTM meeting, I mean, you're the guy whose sole focus is on consumer safety. Is that fair to say? Sole focus. Our sole focus is consumer safety, but we are engineers. We understand the concerns and the difficulties of manufacturing process. Right. And as I understand it, when you looked at the incident data, you basically had about 65% of the accidents that were happening with collapsing tables came from three particular models. Is that right? That's yes. And what you found was that the difficulty that seemed to explain much of these is that these were consumer assembled changing tables as opposed to being done in the manufacturing environment. Yes, that was an observation. And as I understand your recommendation, it's a little bit different than what the ASTM standard is and the one about which there are some negatives, and I understand you're working through it. But as I understand it, one of the reasons, one of the primary reasons that you want to push forward with this and not delay further is that you believe by addressing stability of consumer assembled changing tables, we can decrease the number of children who fall and are potentially injured or even killed. Yes, we're trying to address the injury data, the incidents. And you've been working with the ASTM committee on this, obviously, and they're still trying to address this and that process. There's nothing about us going ahead with the NPR that will in any way impede them progressing toward what their final recommended standard is, correct? Correct. Okay.  We've really concentrated it 2015, but we've been working with them on a routine basis even before 2015. And I am intimately familiar with how long things take here at the commission, but this is basically going to be putting it out there. People can comment. This is not a final rule and we'll continue to work with the standards committee with respect to any differences that we have. Is that correct? That's correct. I think that just with respect to the changes other than the stability, the threaded fasteners that you've explained so clearly in the package that came to us, the rest of them that are differences from the ASTM standard are ones that there have been no negatives. It's just that they're still working on whether they're going to incorporate those. Is that correct? That they have yet to ballot and finish balloting it. So, but yes, they're working towards those. So it could very well be that they'll come out exactly where we are. Is that right? That's correct. I think I have nothing further at this point. Thank you. Mr. Berkel. Thank you. And thank you both for being here this morning and again for this package, which was extremely well written and very instructive. I have a couple of questions. First, I'd like to start, Mr. Kumagai, with some of the questions you answered for the chairman. When you said that we have a good base but we're still working on various things, can you just elaborate for me what are you still working on? The there's essentially three issues that we're working on in ASTM and that we've proposed in the NPR. The first one is structural integrity to address collapsing issues. And in that, we are working on the use of wooden screws, threaded wood screws, into structural elements. We think that those should be prohibited for a consumer assembled units. And is that the only piece on the structural integrity that is in question or are there other factors as well? There's a second part of that. Essentially, a lot of these tables use a restraint, a support system underneath the changing table. And we found that in the incident data, sometimes consumers, we've noticed that consumers did not attach those. So we're proposing to test changing table units without that component, if the consumer has to install it. And before we get to the other two we're working on, you also mentioned that there were some negatives when these things were validated. So while we're still on the threaded screws and the structural issue, can you explain what were the negative and the comments you received back? The gist of the negatives for the structural component issue was on the threaded fasteners, the wood screws. There were some concern that that requirement would make it difficult for a large dresser type, furniture type, but changing tables to meet that requirement. And there was some question. The commenters did not know if they or did not think that those were hazard patterns that they saw in their larger dresser type product. And in that instance, does our agency show to the committee our hazard information and our data that would show that that's why you're encouraging? And can you specifically defend what you're proposing? And do you share that information with the ASCN volunteers? Yes, we make a very good effort to be clear, to be open. We show them all our data. We express our concerns. So yes, we earn all that. We've been open. We still have a bit of a difference in opinion on this one. Now, and I don't think it's necessary with the restraints and the warning and the discussion, because as you say, you're still working on those. I understand what our position is. So maybe you could just address the negative comments. Those also receive negative comments? I should ask that first. Yes. The restraints is currently being validated. The ballot doesn't close until, I believe, I think the end of this week. And the ballot is fairly close to what we're proposing. That's for restraints. The warning labels, again, the task group and committee is still working out some of the details. They have not gone to ballot on that yet. But again, we've been working very closely with them and with the ad hoc committee to develop these warning labels. I see my time is running out. Maybe I can get one more question in. Just some clarification. Page 6 of what would be published in the Federal Register talks about incident data, Roman numeral 3. I just wanted some clarification regarding the data. In the first full paragraph under incident data, it says that other sources include reports from consumers and others through the Consumer Product Safety Risk Management System, which also includes some nice data. And so I'm a little bit confused. Is this information and data that we're getting through our saferproducts.gov? And does the system combine them? Because on the next page, it then separates them out. And so I'm wondering how that all occurs. So the nice data is for our statistical analysis. What we use for developing requirements, we get a little more detail out of the CPR MS data. So when the EPI is making estimates, they'll base it on the nice database, the hospital emergency room data. Well, maybe then, just if you could, and I'm over my time, what does that mean when you say nice data is also included in the Consumer Product Safety Risk Management System? Because if I'm thinking of it correctly, there's the saferproducts.gov. Does nice feed into that system? I just don't understand what the, because on the next page, it separates them out and talks about the nice data. Well, it will explain our S&M expert. Thank you very much. Sorry. Thank you. Hi, so I'm statistician from EPI, and I analyze the data. So for some of the products, children products, they are in CPR MS, like, for example, for creeps. And I'm not familiar, but there are some categories that CPR MS still has nice data. I didn't, I analyze the data separately. So if there was a nice data in CPR MS, I didn't include it because it's included already in nice. But searching CPR MS with the product code for the changing table, you can actually pull also some data that are in the nice, because the changing tables are many times attached to the creep or something. So two product codes are coded for the changing table and the creep. If I'm pulling the data for the changing table, I'm also pulling something. What is in CPR MS? Because it was a part of the creep. And I know one of those products that will be in CPR MS and is nice, there will be like creeps. I'm not familiar with the other products, but I think there are four or five products that are in CPR MS data. Thank you. But I excluded them from analysis of that. The next page when you talk about nice data, that's separate. That's not included what's in CPR MS. Yes. Thank you. Thank you very much. Commissioner Marrova. Thank you, Mr. Chairman. Morning. Morning, Mr. Kumagai and Ms. Kelch. Thank you very much for your presentation today and the package. I have some questions first with regards to process that Chairman and other commissioners got to some of those questions as well. And somewhat, it also relates somewhat recently to a change that we made at the commission level with regards to staff participation and just generally speaking with regards to the durable juvenile nursery products that we call 104 related subcommittees. How are our staff's comments and concerns received by the committee members just generally speaking and maybe in specific with these? I mean, are we treated on an equal and fair footing or are we just almost something just to be listened to and not really taken fully into consideration? We're taken as part of the task group team, subcommittee team where our comments are very well received. And I would imagine that we would feel the same way about other participants, whether the consumer interests, technical interests, industry interests as well. Yes. So it is an effective working environment. I believe it's very effective. It is an effective working environment. Is there a perception among the committee members in the 104s, whether it's fair or not, that our staff is trying to end run the voluntary standards process with regards to the extent to which we subject our recommendations fully to the full committee for their consideration? Excuse me one second, Mr. Goumagai. I'm just gonna ask if you can keep it specific to the changing table, since that's what's the agenda item today, if the commission would like to have a discussion about the 104 process, I do think we need to have set up a separate hearing. So if you could please just try to keep it as much as possible specific to this particular rulemaking or proposal in front of us, that would be great. Thank you. I don't have the committee number in front of it, so it just makes me, I know you know it. The subcommittee for changing tables has been very, we have a very good working relationship and as I said, we had 16 task group meetings. We talk a lot, we pass information back and forth. And I can appreciate that, and you mentioned the fact that the ASTM committee is still working on this particular standard, including some of the recommendations that we've made, is that correct? Yes, that is correct. Yeah. I could take it from my own personal experience when I've got a recommendation. I know that I find great value in sharing and vetting that recommendation with my staff, with my colleagues on the commission, and I find that not only does it give me greater confidence, but often my recommendations will evolve based on the input from those that I would consult. So personally, I find in terms of recommendations that that process has great value. And what I'm concerned about is the extent to which some of our recommendations have had that full vetting by the committee. So what I'd like to do, if you can indulge me, is go through the specific CPSC recommendations that are above and beyond what currently exists in the voluntary standard, and understand the extent to which each one of those recommendations have been fully vetted, or they half vetted, or they still being considered by the committee, because I do have appreciation for Section 104 of CPSIA, as we call them, and the fact that in my opinion and my interpretation of the statute that we were given this authority, the commission was given this authority, should we be thwarted for these particular class of products in terms of our recommendation that we feel are critical and important to safety to, in our adoption of the voluntary standard, to include other recommendations. And I think the shining example of that was the CRIB standard and the additional recommendations that were made by our staff and not to go too much, not to divert too much about the CRIB standard, but I think given that my experience in the private sector in working with product manufacturers in the CRIB industry, I got a better appreciation of the structural integrity elements, and I found, personally came to the conclusion and with my former colleagues in the private sector, how critical those recommendations were. So if maybe we could start, I think I'm going to run out of time, but if, I think three of the recommendation staff has made, if we can conclude with what those are in terms of structural integrity, they would be the wood screws and the threaded fasteners. The second, I'm sorry. Yes, go ahead. Oh, okay. And I may not be fully explaining all of them, but the second has to do with the support systems in terms of testing to performance without the support system attached, if in fact it's designed for the consumer to attach that element. And the third is a performance element for restraints specifically. Does that capture the three main? And labeling. And labeling, thank you. Thank you, Mr. Kumagai. I'll have to wait my turn and maybe if you could think about where I'll be going with those next and looking at the extent to which those have been fully vetted with the spirit that they might be informed by the process, thank you. Commissioner Adler. At the moment, no further questions, but I will wait to see how the further questioning goes. Commissioner Robinson. Kumagai, I just want to make perfectly clear when we talk about negative comments, am I correct in understanding that the only one of the changes that we've proposed that are not consistent with the standard about which there has been any negative comment is with respect to the threaded, I'll put the phrase, the threaded fasteners, is that right? That's correct. And there isn't an objection as I understand that the only negative didn't have to do with the fasteners of consumer assembled products but because that's exactly the same as with other products, correct? Yes. Okay, so the only negative was with respect to scope, is that right? Right, exactly. The objection was just that it shouldn't apply when you're dealing with a changing table that's part of a piece of other furniture. Correct. Okay, and just so I understand, is that other furniture, is it still consumer assembled other furniture? Yes. Okay, so if you go in and buy something in a furniture store that is a dresser and it has a changing table and the manufacturers put it together, this requirement wouldn't apply, correct? Correct. And Mr. Kumagai, based on what you've seen in the task groups that I'm delighted to hear are working so effectively together, do you expect that the ballots on the other issues about which we have a little bit of difference with the committee will be, what they'll come up with will be similar to our proposals or don't you know one way or the other? I don't like to predict, but if I were to predict, I would say yes, they're gonna be very similar to what we proposed. I've heard that it's hard to predict particularly about the future. And as I understand it, if we move forward in parallel as we're proposing to do, obviously that's gonna be more efficient, but with this process of the NPR, we will have the advantage won't we of not only having comments from the committee, the ASTM committee, but also public comments. Okay, thank you, I have nothing further. Commissioner Berkel. Thank you. Mr. Kumagai, I'd like to go back to the consumer-assembled changing tables. Is there in our data, does it break down the injury patterns for consumer-assembled versus what Commissioner Robinson was just mentioning when the furniture store puts it together and it's not consumer-assembled? Have we broken that down? That's difficult to get from the data. What we do is we take a look at the data and the photographs and try to match it with some of the product that we've had to look at. And for this particular case, we know that a majority of the incident product we know has used wood screws to assemble them. And it's a consumer-assembled product. So wood screws is a determinant that the consumer assembled it? No, we know that the consumer assembled it and it's pretty typical of this type of product. And we know that in a lot of the incidents the product is assembled using wood screws. So we don't know for certain which ones were consumer-assembled which ones were already assembled when they bought it. We have to make a judgment on that based on what we know from the brand that we see in the incident data. I wanna go back to where we were before in my first line of questioning. You mentioned the restraints were being balladed and would be completed by the end of this week or could you just explain when you say the end of this week what does that mean? So the restraint, ASTM balladed a restraint requirement and the ballot will close at the end of this week and we will determine whether there's negatives that need to be addressed. So to Commissioner Robinson's point we don't know whether there might be negatives on the ballot regarding those restraints. There's always that possibility. And this may call Epi back up to the table. Do we have a specific code? What is the nice code for changing tables? You mentioned sometimes the crib and how that can conflate. But can you just? It is in the one, five, two, two I believe but I pull not only the product code for changing tables since sometimes as I say the changing table can be attached to the play yard for example and maybe the product code is missing. So I also pull for example products that are coded as a play yard, as a cribs, as a business. So there were like 10 I believe product codes that I include and also I include some keywords to help me to search for the changing table. I didn't want to miss anything and there were incidents that I did not pull with just using the code for the changing table. So there were additional incidents that I put with the other product codes that were not coded as a changing table but there was a problem with the changing table. So I'm sorry in the footnote of my memo there are 10 product codes that I'm mentioning the one, five, I'm sorry I didn't take my glasses but one, one, five, two, one, five, two is a changing table. One, five, two is a changing table. It's in the footnote of my memo to Mr. Kumagai. There is a footnote and I put all the 10 product codes that I was searching the database with but yes the product code, the main product code for the changing table that the most incidents were pulled it is one, five, zero, two. And so that code along with nine other product codes is how you get to the assessment. Yes, we're used to look at the changing table data and as I said there were some additional incidents that were not found with the product code for the changing table. How comfortable are we that that information is accurate if we're pulling in other product codes and? I read, so when I pull the data I have to screen the data if it's in scope incident. So for example the changing table can be mentioned if something fell on the changing table. Let's say the lamp fell down on the changing table, yes. Both product codes are coded as a lamp and the changing table but it's not the fault of the changing table. Yes we cannot say that the changing table it's in the fault, nothing indicates for that. So I have to, when I pull the incidents there were probably over 2009 incidents that I pull and I screen the incidents. Does it mention the changing table? As I say I also use the keywords when I was pulling the, when I was using the other product codes and the product code for the changing table. I was looking for example for change as a one keyword that helps me also narrow down what I'm pulling but I have to read, manualize, sit and read the narrative of the each incident and decide and there is also for example some incidents were considered out of the scope when the child runs and hits the changing table. Yes there is nothing we can do about that. Child can run and hit the table or another piece of the furniture. So there is a lot of screening then the team also looked at incident that I pre-screened and agree with me or not. We also excluded the incidents that are not for domestic use. For example incident happened in the store. So for those kind of things we just have to read and the team also goes and checks it. Thank you very much. I'm out of time, I'm over time. Thank you very much. Commissioner Mojarova. Thank you Mr. Chairman. Mr. Kumagai, you mentioned that if you had to predict you'd say they'd be very similar in terms of the recommendation where voluntary standard. That because they agree or because they see the writing on the wall in terms of something that will eventually be the position of the commission and we might as well get on board right now because otherwise it'll be time to try to resistance is futile. Is that the approach? On these last two the warning label and the restraints I think, no I think we're they're doing the best they can. They're balloting what they believe is wreck ballot. So no it's not because we're influencing it in that manner. Oh okay. But we are a part of the task group. So we hear our opinion is known. Right, if not it's well known right now but I'm sure it was well known when the package came out. In terms of the first getting back to the wood screws with the metal threaded fasteners and the glue. You mentioned that in May 2015 was a presentation of incident data to the subcommittee. When was the recommendation made by CPSC for this particular change? What approximate date was that was that presented to the subcommittee? I'm not quite sure what the approximate date is. Now just to be clear this the requirement that we said or that we're recommending is a requirement that's used on other consumer products. Cribs, high chairs and what we do know is that it was balloted on let's see 5 May 16th, 2016. So it had to be discussed prior to that and it was discussed during task group meetings and till it became to a point where the task group was comfortable in balloting it. Now in terms of the consensus the driving towards consensus in SDOs generally does the point in time where the, well the ballot would the ballot be by the subcommittee this is the full subcommittee or would it be the, is it the task group or the working group? It's a subcommittee. So the changing table subcommittee will ballot that. Thank you. So when that ballot at the point in time that the committee or the subcommittee chairman feels comfortable in issuing a ballot is that because consensus has been reached or is that to gain a better understanding of the full subcommittees position on the subject? It can be both, it can be either or or both. What do you think it is in the case of this particular recommendation with the structural integrity of the wood screws? In this case, I believe it was, there seemed to be consensus amongst the subcommittee to move forward with that. Okay, outside of this one situation I imagine with where the changing table is part of a greater product does a recommended change regarding the ban on the use of wood screws include an exemptions for products like that, addresses with changing tops which are not likely to be disassembled? Does it, does it have a carve out for an exemption for products that are not likely to be disassembled if in fact the rationale behind having this recommendation is because the products are often disassembled and without this particular kind of hardware then there could be a question as to the structural integrity. However, when the changing table is part of a bigger, much bigger component product and I've got some of those still around the house today but it's unlikely that that would be disassembled, put in the basement or the attic or the garage and wait for child number two, three, four, five is there a carve out for those other particular, for those type of products, an exemption? There's not an exemption in the NPR. And nor in the balladed, in terms of the voluntary standards work too, I imagine there is not an exemption. At the original balladed standard, there was no exemption. You think there should be an exemption? I have not come to, no, I haven't come to that conclusion. We're willing to take in public comment and of course work with ASTM to determine if there's a better way to make this requirement. Thank you. Now with regards to testing the performance of the bed in 20 seconds or less, when was that recommendation presented to the subcommittee in terms of the performance requirement, the second one with structural integrity, if there is a strap involved to provide more strength to the base to test that without the strap attached, if in fact it was part of consumer assembly. There's not an exact date where we propose that our engineers and Patty who was the project manager there was constantly working on that. So we could allow maybe staff to respond with 30 seconds. The extent to which that recommendation is all I'm getting to, not exact dates. Can you just tell me the extent to which that has been discussed and what the outcome is? I'm trying to understand what kind of consensus has been. Yeah, I'll try and get a little bit of a background. The collapsing issues started a long time ago before the 1.0 rule and we've always been part of the task group and it eventually started and became a much bigger deal. It was a dynamic test where they were gonna cycle everything and put a lot of loads on it. They were gonna do a diagonal force test and once we got involved in the 1.04 process and started doing our own testing, we came up and said this is overkill. This is way overkill. It's like a lot more than I did with my three recent kids on a chain two. Right, and so we looked at the kind of products were involved and that's when we discovered it was the consumer assembly problem and this was in about, we did all the testing in the summer of 2015 and so in October of 2015 we presented the data at the October meeting in 2015 and from then on we started to pare it down. Okay, so we don't need to do all these huge convoluted cyclic tests, what should we do and that's when it started formulating from then on. Thank you very much, Matt. Do any commissioners have any further questions? Commissioner Adler? Yeah, I appreciate Commissioner Mohorovic's questions and he seems to be leading to a point that I thought I would just ask directly and that is when I look at section 104 it says that we're supposed to promulgate these rules as consumer product safety standard when we find that they're substantially, that the rule we wanna promulgate is substantially the same as the voluntary standard or is more stringent than the standard if we determine that a more stringent standard would further reduce the risk of injury so my question is as follows, if we had found that there was a consensus that we didn't think was a correct consensus in other words we didn't think it really adequately reduced the risk of injury is that our mandate or is it your mandate to the staff who's participating that they defer to the voluntary standard process or is it the case that we would then make a recommendation that may not agree with the consensus standard but that is more stringent because we think it promotes safety? Yes, your summary of the requirement under the CPSA. We have two alternatives. One is to adopt a requirement that is substantially the same as the voluntary standard and alternatively where staff in the commission conclude that additional more stringent requirements would further reduce the risk at the option to adopt such more risk requirements as an alternative. And I do see that 104 calls for extensive consultation with all stakeholders and listening to Mr. Kumagai discusses it sounds like we've been over backwards to do extensive consultation and the consultation continues. Am I correct in saying that? Yes. Thank you. Commissioner Robinson. A couple very quick follow-up. Mr. Kumagai, can you just explain to us what it is that's the concern with respect to the threaded fasteners when consumers put these things together? Or threaded fasteners such as wood screws or wood screws that go into wood on structural components. It's been our experience that consumers can over tighten those screws and strip them out or not tighten them enough or repetitive use will eventually make that fastener degraded. And that could explain them collapsing? Yes, these are structural key structural components that they're being used in. And could you just tell us why it is that you're proposing the NPR now instead of waiting for further balloting by the ASTM? We're pretty confident that our requirements are sound. That they will address the incidents that we've seen in the data. And this is, we're ready to go. We're ready to get some public comments on that. Commissioner Robinson. I'm sorry, Commissioner Berkel. Thank you. I wanted to go back to where we started in the first round of questions with the balloting. So if that ballot comes back, that's out and gonna be closed by the end of this week, comes back with negative feedback. What then happens? What is the normal process? The subcommittee will determine whether those negative comments are valid or persuasive. If they are persuasive, then the ballot fails and the task group or the subcommittee group will go back to working those issues out and trying to address the persuasive comments. And will that happen even if we publish an NPR? Yes, that will happen. In the, I wanted to ask a question about package. The package claims that the ASTM committee has authorized the committee to print the requirements of the ASTM standard. And because they're essentially the same. Can you just comment on that? So is the ASTM committee okay with this? Are they, what is their feeling? Obviously, voluntary standards are consensus. What they gave you the, or they authorized the commission to print the requirements. So are they okay with us going forward and publishing the NPR? That was simply to address copyright issues because it's ASTM's document for the purposes of us publishing it. Okay, so it has nothing to do with? It wasn't, that wasn't part of the discussion. It was purely a copyright issue. Good, Mr. Kumagai, could you speak to that? What the ASTM, I mean obviously there must have been discussions within the various task force. What is their feeling about us publishing this NPR and not letting the rest of the process play out? We were very clear that we were publishing the NPR. I personally didn't get any feedback on whether we should or not, but we've made it very clear that our schedule was to publish an NPR at this time. And when we got closer to it, I continued to inform them that's what we were gonna do. I also just add that because this is a proposed rule, we're only at the NPR stage, this doesn't preclude us from potentially aligning with ASTM should their standard move ahead in the same direction our proposed requirements. There have been a few 104 rules in the past where either at the final rule stage or subsequent to the final rule we have ultimately aligned with the ASTM standard when the requirements eventually align. And I'd like to augment to your question about the scheduling and so forth. One of the things that I did in the past and Celestine is continuing to do is we keep a chart of what our milestones are for the various 104 rules and we share it with them. And probably at every meeting, it's one of the last questions. So can you get an update on the NPR? And we will always say, well right now we've got it scheduled for May 2016 and only on one occasion has that date ever moved up. Most of the time it slides. So the next six months we report and go, well, now it looks like it's gonna be postponed a little. So they are kept well informed of exactly on all the different one of four rules of exactly when staff has it on our milestone calendar and when it's coming up. So in this case, why, and my colleagues know I'm kind of a stickler for what Congress directs us to do, but why in this case aren't we gonna let it, we won't let it slide until and unless we're just gonna go forward because our schedule tells us to, where in other cases we let it slide. What is the call there? Reasoning for that, for that decision. We decided to go forward because we were comfortable with our proposed requirements. We don't, and it's addressing the hazards. We think that we need to get that forward, moving forward to get public opinion on it. I don't, I can't predict where ASTM will be and how, what their schedule will be. I don't have control over that. Thank you, I'm out of time. Commissioner Mohorovic. Thank you, Mr. Chairman. Mr. Kumagai, back to the support system, performance element of the test. I think you mentioned that that was, is that out for ballot currently? That one got combined with the wood screw ballot. And so since we got negatives on the wood, or yes, since the wood screw issues got negatives, the entire ballot failed. And then it waits for more discussion until either the negatives are withdrawn or the committee as a whole feels comfortable enough that there is enough consensus to adopting those, correct? Well, currently, yes, those are, those are some of the alternatives current and for this particular case, the committee is reworking their requirement. It hasn't, it's not ready for ballot yet, but they're reworking it. They're trying to address the negatives. But it did receive the benefit of having that those two elements vetted through the ballot and we were able to receive the negatives. I'm sure that as a member of the committee, you were able to do identify and consider some of the negatives that came through. Yes, we were, we were part of that. And put that into consideration while still recommending, recommending the CBSA. Understood. Now, in terms of, I don't know if it's fair to combine the other two with the restraints, with the restraints recommendation. We're recommending a performance requirement for restraints, but restraints are not required in the, in the product. Is, do you find that, that seems a little bit unusual to me to require a performance element for a, an added safety feature, but yet at the same time, if we thought it was important enough to have a performance element, why aren't we requiring that as, as also part of the, the overall requirements for the product? Yes, that, that's exactly the discussions that we've had with the task groups. And the task groups, the committee that we came to consensus that if you're gonna offer a restraint, then it should be a good restraint. Okay. And an adequate restraint, but we don't, our staff doesn't feel that for this particular product. It's critical enough for safety to be a required element. Would that be correct? That's correct. It's, it's not required. Thank you. And those, those, that in the, in the warning label recommendations, those are currently out for ballot. The restraint is currently out for ballot. Thank you. Warning labels are not. Not out for ballot. So with the, with the restraints being out for ballot, how we has the, has the ballot period where members are, there must be some timeframe associated with the ballot in terms of when committee members must submit any negatives or other comments related to the ballot. Has that expired or is that still an open period? It's still open. It's still open. Okay. And with the warning labels, we haven't, that has not yet been balloted. No, it has not. Do you believe it will be balloted? They're, the task group is definitely working on it. Yeah, they're getting close to balloting it. You think that if it was not an element that staff was recommending or we include in an NPR, would it still be balloted? The recommendations that, that staff is making right now for the warning labels, would that recommendation still be balloted and considered among the commission? If in fact it wasn't part of the additional recommendations that we might include in an NPR? I believe, if I understand that correctly, are you saying that if we didn't say anything about the warning label, the committee would be- Yes, would you expect that that would still be balloted in the SDO realm? I think that we've been working very closely with them and yes, I think they're, throughout the entire 104 issues, we've looked at warning labels and we update them and yes, I think they would do it on their own too. Okay, so to inform this NPR, we have had the benefit of receiving the comments in terms of the four additional staff recommendations on the wood screws and the threaded fasteners. We have had the benefit of understanding what the voluntary standard committee feels about those. We have had the benefit from having had the ballot open on the support system performance requirements and what the committee feels about that. But we still, it's still an open period right now for the performance requirements with regards to strengths. Restraints, but we do not have any benefit of the committee's input with regards to our recommendations for warning labels. That's correct. Okay, thank you, Mr. Kumagai. Ms. Couch, can you do me a favor please and turn to a different part of the statute that I don't think we spent enough time on, which is the time element of 104s and where this fits in. If you could please just remind the commission what the annual requirement is in the statute, crystal clear from Congress in terms of producing 104s such as changing tables on a regular basis. Now Chairman, you did want us to only talk about in respect to this particular one or are you objecting to your own objection before with regard to having a general discussion about section 104s? Including how changing tables fits into that. Chairman's powerful guy. Yes, the original directive in the CPSIA under section 104 was within one year of enactment of that statute to commence rulemaking and thereafter to promulgate standards for at least two products every six months thereafter according to the commission's determination of priority. And is there, when we do something like changing tables is there anything that you see in the statute that calls for the commission to put that aside to work out further discussions with the voluntary standards process? Does it override that temporal requirement? Is there anything in the statute that says that if ASTM has not yet validated or has not yet finished clearing out negatives that that overrides that statutory requirement? No, it does not. There's also an additional requirement, well additional provision relevant to section 104 that allows for the commission. Actually it provides that any standard the commission adopts automatically updates subject to action when a group such as ASTM updates their standard and applies the commission. So fair to say that based on what is in the package in terms of staff's concern about as Commissioner Adler mentioned the statistical significance of the increase in injuries. There's a safety concern and there is also a time element to keep these moving to keep items like the changing table proposed regulation. That is consistent in your mind with staff's mind with congressional intent. Yes. Thank you, Commissioner Adler. No further questions. Commissioner Robinson. Nothing further. Commissioner Burkle. I want to spend just a few minutes on warning labels because this is a recurring theme and we were very appreciative of the briefing we got on warning labels. But there seems to be in the three years I've been here a shift in warning labels and how we view warning labels certainly the value of warning labels. And so as I want to comply with the chairman's requirements I want specifically with this product. Can you talk about the warning labels? You know what has changed and I think more broadly with regards to warning labels the agency's position. I hope Nestrack is our warning labels expert. I think and actually this gets back to something Commissioner Morović said a minute ago asking about if the warning labels have been validated. A good portion of that has been the formatting requirements that has gone through probably a year's worth of discussions with an ad hoc task group. And so what happened because the warning labels were different among the various 104 subcommittees 104 related subcommittees. They formed a task group that was across different subcommittees and so we called it the ad hoc wording task group I think was the exact name. And so they worked to get the formatting requirements to conform or be consistent with ANSI requirements and that was based on some of the previous 104 work we had done I think with bouncers in particular but and so based on that we worked Tim Smith who's back here too also worked very closely with that ad hoc group to come up with those formatting requirements. And so because we've worked so closely with ad hoc group because these various subcommittees are actually putting those out to ballot and passing them in ballot and putting them into their standard. So we included those here. So does that get at your question? Yes, it helps. So the ad hoc has warning labels and some of the issues related to that validated right now. No, actually they were validated back in March into April. Okay, and that's completed. Yes, it's completed because it's not a standard but it is available for all the F-15 subcommittees to look at and it has been validated. They received comments on it. They made a couple little tweaks in it. In particular, there was one figure that it had like six different examples of what the word left justified meant. And that for example, we did not include that was in Tim's response to the ad hoc committee that and the ad hoc group has actually now moved that and recommending it be included in the appendix to the standards. So it's not actually in the text. They're not recommending it in the text of the standard anymore. Thank you. That's all I have for now. Commissioner Mohorovic. Do any commissioners have any further questions? Hearing none, we and thank you to the staff for that and especially it was also for the staff who jumped up not anticipating having to be joining today. It was very helpful. We're now going to turn to consideration of the package in front of us. Are there any motions? Commissioner Mohorovic. Chairman to explain the motion. Yeah, please take a moment to explain it and then I'll ask for a second. Understood. Thank you, Mr. Chairman. I move to defer the vote in this matter for six months in order to allow the ASTM subcommittee to finish its current round of revisions and balloting. Congress designed the 104 process to allow the product experts, including both the voluntary standards community and our staff to fully consider each change before the CPSC relies on those standards. If there are ideas for changes to the changing table standard, including some of the ones recommended by staff here, we should give the subcommittee time to vote and consider those changes fully. If some of those changes are rejected by the voluntary standards committee, but our staff feels strongly about them and have the facts to support the positions, then we absolutely have the right to make safety changes beyond those from the committee in the interest of safety and we should do that. However, because it sounds like the voluntary standards committee has not been given time to finish their work and actually have ballots out right now or going out very soon, we risk prejudicing the voting members by sending the signal that whether it happens in the voluntary standard or our mandatory rule, the outcome has already been determined. Mr. Chairman, that's not how I believe this process is supposed to work. I think we owe it to the experts, including our staff who have devoted their time to carefully consider these changes, the opportunity to finish their work before we try to force these changes through. We need to let the process play out and I think six months is a sufficient time to do that and to make sure we get this right. Thank you, Mr. Chairman. Thank you, Commissioner Mohler. Do I hear a second? Second. Having heard a second, we'll now turn to consideration of the motion. I'm going to start and just say that I do not support the motion. I think it's entirely inconsistent, both with the data, with the work that was done, with the safety directive that is clear in the CPSIA and with the time requirements. And for those reasons, I will not support it. Commissioner Adler. I strongly, strongly oppose Commissioner Mohler's motion. I think that what we've seen in the changing table example is a terrific precedent for how the commission should interact. We continue to consult, even as we're moving forward, we continue to listen to them and continue to consult, but I'll state the obvious. Safety delayed is safety denied. In the interim, people are going to have children injured on changing tables that it might have been made safer. So I just cannot see by any interpretation of events that this is promoting safety. Commissioner Mohlerovic. Plus, this is a terrible precedent. The idea that you can delay a proceeding simply by walking in at the end and offering amendments is an invitation to bad behavior. So I'm not saying that occurred here, but if we were to extend this for six months, that would be the example we're setting. And I'll just make a quick, broader comment. Sorry about this, Chairman Kay. But one of the best things happened to this agency, as far as I'm concerned, is having Patty Edwards designated as our Voluntary Standards Coordinator. She has hit the ground running. She is vigorous. She has the respect and admiration of the Voluntary Standards community. And she is going to help us accept the reality that so much of what we do depends on Voluntary Standards development. And if we're going to do that, we have to have cooperative Voluntary Standards groups, SDOs, but we have to be very strong in these committee meetings to make clear what the commission's position is. We are not supposed to be deferring to standards that we don't agree with. So for those reasons, I strongly oppose Commissioner Mohorovic's motion. Commissioner Robinson. I echo absolutely everything that Commissioner Adler said, particularly with respect to Ms. Edwards. These are tediously long processes that we go through both with respect to the NPR and a final rule, and with respect to working for years in Voluntary Standards committees. We know in this case, as Mr. Kumagai has not only told us, but demonstrated, we know what can keep children from being injured by these tables. We have the solution and to delay any further in getting it to a mandatory rule is something that I would strongly object to, especially keeping in mind that no matter what we do, even if we delayed, then we'd still have to go through this process of getting public comments, analyzing and so forth, and there's absolutely no reason to delay this any further and allow more children to be injured or killed. I vote against this. The stickler for congressional deadlines, Commissioner Burkle. Well, if we were consistent, I would be, we're not consistent on these 104s. We have not complied with the statute. I've brought that up before. And so, I think really if, and I will be supporting the amendment, and it isn't, it's not any disrespect to Voluntary Standards Committee to Ms. Edwards. It's nothing at all. It is about process. And it seems to me we should let this play out like we do in most other situations instead of preempting, let the consensus process work out. Commissioner Adler mentioned about what the commission's position is. It isn't our position, it's the staff's position. It's what gets worked out in the Voluntary Standards process. And I just, I can't understand why in this case we're being a stickler to the deadline and in so many other cases, as was mentioned, we let them slide for a whole variety of reasons. None of which are negligence or it's just for reasons. We say we're gonna wait until the process plays out and then we'll either incorporate by reference or we will apply more stringent requirements to that Voluntary Standard when it comes to the 104s. So I just, I'm more of a process person and it just seems, I can't understand why we're treating this any differently than we treat some of the other 104s. Commissioner Mohorovic, last word on your motion. Thank you, Mr. Chairman. I think if we're going to just forge ahead because we feel strongly, I think we ought to ask why we would even bother, why would other members of the subcommittee, I mean, even bother to spend their time coming up with their expert opinions? I mean, why not just let the CPSC do our thing? Why not create just a standard that's just a blank sheet of paper since the CPSC is going to do what it wants to do regardless and aren't we diminishing maybe even insulting the value of their expertise? I mean, what's not missed upon me is the fact that we crank out 3,000 regulations in this federal government and the extent to which we can pump the brakes with the process to understand that instead of just doing that in an overbearing fashion, we're trying to build consensus which to me is more about the spirit of the 104 and not just giving us a blunt instrument and in the opportunity to just wield it and hammer down any negatives that might come up. I think the extent to which we start to pump the brakes on the regulatory government, the $2 trillion anchor that is making the United States a less competitive international presence, I think we ought to also be careful about the extent to which we play into the idea that the federal government is patronizing, condescending and overbearing. Thank you, Mr. Chairman. I now call the vote on the motion by Commissioner Mohorovic. Commissioner Adler, how do you vote? No. Mr. Robinson. No. Mr. Berkel. Aye. Commissioner Mohorovic. Yes. And I vote no. The nays are three, the ayes are two, the motion is not agreed to. Are there any other motions? Having not, having heard none, we now move to the consideration of the final package. I move to approve the notice of proposed rule, safety standard for baby changing tables and to publish the same in the federal register. Is there a second? Second. Having heard a second, we'll now turn to final consideration of the package and I do wanna remind the commissioners, of course, they'll be closing statements. I have no further comment at this time. Commissioner Adler. No further comments at this time. Commissioner Robinson. None at this time. Commissioner Berkel. Nothing further. Commissioner Mohorovic. Having heard no further comment, we now move, call the vote. Commissioner Adler, how do you vote? Aye. Commissioner Robinson. Aye. Commissioner Berkel. No. Commissioner Mohorovic. No. And I vote aye. The ayes are three, the nays are two, the motion to approve staff's proposed rule, safety standard for baby changing table products and to publish the same in the federal register has been approved. We will now move to closing statements. I'm gonna keep it brief. I do think it's important to point out that Congress addressed the issues of what the priority should be and what the timetable should be, what this rulemaking, Congress went through all of the policy considerations of adding to the regulatory process and made a determination which I strongly support that in the name of infant and baby and toddler safety that the commission should move expeditiously to consider as we have here. A proposed regulation and if the commission, as we've now approved it, believes that it can be made more stringent based on the data, based on the incidents, based on engineering solutions, as again has occurred here, that the commission should go ahead and move that. So I think that in the time that I've been here, this has actually been one of the best processes that I've seen about staff following the 104s as they were written. One can interpret it differently but that would end up being a different statute. And for all of the other considerations that others may have, that's a congressional determination to make. I think Congress spoke loudly. I think it spoke clearly. We do endeavor to stay on track with these. I certainly continue to push staff from my perspective and I'm sure I have at least two other commissioners that would agree, creating a majority, that staff should continue to press ahead, continue to follow the statute to a T as you have, work with the voluntary standards, evaluate, consult, but when you reach a point where you've decided that you believe based on the incident data and your solutions that people will be protected, kids in particular, by what you're working on, there is an urgency to move these rules. And so I applaud what you've done here. I think you've made a big difference and families across the United States will definitely benefit from your work. Thank you very much, Commissioner Abbott. Thank you very much. And I do have a couple of quick observations. The $2 trillion regulatory figure that Commissioner Mohorovic announced is one that is hotly contested, I'm sure he knows. There are many people who look at that figure and scoff at it, but even if it were vaguely, vaguely accurate, which I'm sure it's not, it says nothing whatsoever about the trillions of dollars worth of benefits from regulation, which anytime there's been an analysis far, far outweigh the costs, which by the way are typically short-term costs and often drop much more quickly than government estimates because costs are easy to estimate when you're doing a regulation. Benefits are much harder to estimate and they happen over a longer period of time. I also think it's a false alternative to say that we either are ignoring the ASTM process or else we're doing it that we're accepting what they say. Congress gave a mandate to us in the 104s to consult, to listen, to share information, to cooperate, to collaborate, but there's no mandate that we agree. The mandate is that we focus on safety and that's precisely what the staff has done and I commend the staff for an excellent job. Commissioner Robinson. I am puzzled by Commissioner Burkle's comment about us not being consistent with respect to how we go about with our 104, go about our 104 NPRs. I am, since we've both been commissioners, we've had several occasions when NPRs have been presented to us while the process is still ongoing the ASTM process and we have fully worked with them in working toward a final rule. I am not aware of any instance at this agency either during my tenure or before when we have kids being injured or killed by a product. We know the solution. In this instance we have one tiny negative comment with respect to scope and from there to engage in the hyperbole that the federal government is condescending and overbearing and bring in all federal regulation whether contested or not reaches a level of hyperbole which would be amusing where we're not living in the political environment but we're living in in this country right now and I don't find it amusing. I think this is exactly what we should be doing in terms of going forward on parallel tracks. We know the solution. We know how to keep kids from being injured and we should go forward with it as quickly as possible. We've worked with the ASTM process for two years. We have a tiny, very tiny areas of perhaps disagreement, perhaps even not. That process will play out while our process is taking in comments from the public that are not part of the ASTM process. We'll have a 75 day comment period and then we'll hopefully visit to the final rule as quickly as possible. As Mr. Kumagai said, he's comfortable. He's got the answer on how we can save kids from injuries and death. So the idea that we would delay any further would make no sense whatsoever. Commissioner Berkel. Thank you and I again want to thank all of the staff for the briefing package and for this morning and for the information you shared with us. It's all very helpful. There's no denial and it's an important part of what our staff does and that is to play a very important role in the voluntary standards process. In fact, the commission has authorized the staff to now be able to vote and also to be a chairman of a subcommittee on the voluntary standards. So I recognize and appreciate all that gets done. In fact, so much gets done in the voluntary standards committee. So I don't want that to be a part of, I don't want that to be construed as a lack of respect for staff and all of the good work they do with voluntary standards. So many of the comments here from the dais just now are far beyond changing tables. I'm focused on changing tables today. Not anything else and process to me is important. It always has been and that's why my concern and that's why my vote this morning. We're asked to vote on an NPR for changing tables but after two years of working with the voluntary standard and the STM, the balloting hasn't been completed. And as Mr. Kumagai mentioned, the outstanding issues are the structural integrity, the restraints, the barriers and the warning labels. There are differences and disagreements still to be worked out on the warning labels, as I mentioned. It seems to me this package has just come up prematurely. We're being asked to vote on publishing a proposed standard that has not been finalized. We are being asked to apply more stringent requirements to a standard that's still being worked on. The voluntary standards process is a well-regarded, time-honored system comprised of professionals from industry, government and consumer groups who bring their expertise, their practical experience and their vision to create strong voluntary standards. That's an important part of what we do and how we accomplish our mission of safety. It's important that the voluntary standards committees and the system maintain its integrity and that the process is not needlessly disturbed. CPSIA section 104 provides CPSA the legal authority to move beyond the voluntary standard if we believe that improvements to the voluntary standard will further reduce the risk. I'm concerned at times that our staff is invoking the authority prematurely to make standards more stringent. Is it because we perceive that the debates and the technical dialogue that goes on within the standards committee is moving too slowly or is it influenced by, as was suggested by myself, that the internal agency's pressure on staff to meet the end of the year requirements? Regardless, I think just think that the package was brought up a little bit prematurely before it was ready to be published. As an agency, we need to make sure we do not reduce the quality of our draft rules or create unintended consequences in the marketplace. We must not minimize the concerns of our industry partners making assumptions about what we think should be incorporated into the voluntary standard or succumb to timelines that shortchange the process. If we are to recommend more stringent standards, I think it is incumbent upon us to make a strong showing that the additional requirements would further reduce the risk. At the very least, before we say more stringent requirements are appropriate, there should be a final voluntary standard. We should be careful to give the ISTM Committee ample time to consider our proposal, do the testing that's necessary, and evaluate the changes and come up with alternative procedures that accomplish the same ends, perhaps at a lower cost. We are a government agency, and we have a higher bar, I believe, because we have that legal authority. Additional authority always carries with it additional responsibility, and we must not invoke our authority unless it is necessary, and we must make that a compelling case to do so. Our staff brings a depth of knowledge to the standards process, but as a government agency, we must respect and encourage creative concepts, new designs, and innovation by American ingenuity. We must resist the temptation that we know best before all the other ideas are out on the table. We should not lightly override the judgments made in the consensus process because Congress gave us the extraordinary authority to do so. When we exercise our authority, we should make sure we are doing so responsibly. We should be careful to give the voluntary standard committees ample time to digest our proposals. I realize that Congress has imposed a rigorous timeline when it comes to the 104 activities, and I have been consistent with how I think we should, for the best of our ability, comply with congressional intent and with congressional direction, but I think we also need to be consistent. We can't cherry pick the issues that we wanna be timely on. I also believe that if the congressional timeline is unrealistic or puts undue pressure on staff, then we should go back to the Hill, engage with them, and perhaps revisit the schedule for durable nursery products. A well-reasoned data-driven robust and thorough debate and preponderance of all the evidence is the better way to proceed. The integrity of the ASTM consensus standard process must be maintained, and proper procedures and practices upheld as well as our own. Thank you, Mr. Chair. Commissioner Moorovic. Thank you, Mr. Chairman. I'll be very brief. First, I would just like to associate myself with the words of my colleagues, Commissioner Adler and Commissioner Robinson with respect to the participation of staff in this particular matter in contribution to this hearing today, as well as those associated with our voluntary recall coordinator, Ms. Edwards. I would also like to just associate myself with, I think, Commissioner Burkle's close, which I think was very well done. I had ample opportunity to express my feelings about this particular matter, and I think to the extent to which the Chairman allowed it, our approach to 104 process in general. So thank you very much. This concludes this public meeting of the United States Consumer...