 Good morning, everyone, and welcome to the U.S. Consumer Product Safety Meeting this morning. Today we have one agenda item to consider. We will be briefed by staff on a proposal to publish a notice of proposed room-making that would establish a safety standard for carriages and strollers pursuant to the Danny Keyser Child Product Safety Notification Act, which is Section 104 of the Consumer Product Safety Improvement Act of 2008. The CPSC staff has recommended that we publish the draft proposed rule that incorporates by reference ASTM F833-13. ASTM F833 is the voluntary safety standard for carriages and strollers. Staff has recommended that we incorporate by reference ASTM F833-13 with one addition to address scissoring, shearing, and pinching hazards associated with 2D strollers. And you will find out in the briefing what a 2D stroller is if you don't know. Staff is also recommending that the commission propose an 18-month effective date following the publication of the final rule. Before we begin the briefing, I'd like to say thank you to the members of the team who worked so hard on this package. Creating a safety standard that addresses strollers and carriages is challenging because there's so many styles and designs and each type may represent different risks to children. So thank you for your hard work, Rana Balche-Sinha, we appreciate it, Haiyan Kim, Gregory Ray, Angie Chin, Stephanie Marquez, Jonathan Midgett, Mike Lee, and Jill Jenkins. I have great admiration for your dedication and professionalism and wanted to take a moment to express that sentiment from all of us. So today we'll be hearing from Rana and Haiyan and Greg. So with that I turn it over to Haiyan. You want to begin? The Danny Kaiser Child Product Safety Notification Act requires the commission to issue safety standards for durable infant or toddler products. The commission is required to follow the Administrative Procedure Act which requires notice and comment rulemaking. The matter before the commission is the notice of proposed rulemaking for the safety standard for carriages and strollers. Any durable infant or toddler safety standard that is issued by the commission must be substantially the same as the voluntary standard or more stringent if the requirements would further reduce the risk of injury associated with the product. The commission was directed to issue two new standards every six months and periodically review the standards to ensure the highest level of safety that was feasible for such products. The proposed rule incorporates the ASTM's standard consumer safety specification for carriages and strollers with an additional requirement to strengthen the standard. Rana Balchi-Sinha will discuss the proposed standard and proposed modification of the standard. Greg Ray will demonstrate some of the hazards presented and the test methods used to help address those hazards. Okay, thank you, Hyam. Good morning, Chairman, Commissioners. I would like to start my portion of the briefing with the definition of a stroller and the major types of strollers that are covered under the standard. ASTM F833, the voluntary standard for carriages and strollers, defines a stroller as a veiled vehicle for the transport of infant or children generally in a sitting up or semi-reclined position. The motive power is supplied by the person moving at a walking rate while pushing on a handle attached to the stroller. Carriages, on the other hand, shown on the upper right hand of the slide, are vehicles used to transport an infant usually in a lying down position. Strollers are normally used for infants through 36 months of age. Strollers that fold in two dimensions, meaning height and length, are called 2D strollers. We have two examples here and if you would like, we can show you how it folds. And the second type is called 3D strollers and they fold in height, length and width. If a stroller is intended to be used at a jogging rate, then it is called a jogging stroller. An example is shown on the lower right hand of the slide. Travel systems accommodate an infant car seat on a stroller. Strollers can accommodate more than one child. Side-by-side strollers allow two or more children to sit next to each other, while tandem strollers allow them to sit one behind another. In addition, multiple occupant strollers, which are often used in daycare situations, are also available for private use and can accommodate up to 10 children. STM F-833, Standard Consumer Safety Performance Specification for Carriages and Strollers, is the primary voluntary standard. It was first published in 1983. It has been revised 20 times in the last 29 years. Currently, the standard includes general requirements and performance requirements, as outlined on the slide. It is required by Section 104 of the CPSIA. Commission staff started consulting with representatives of consumer groups, juvenile product manufacturers and independent child product engineers and experts to examine and assess the effectiveness of the standard. This consultation commenced in January 2011, with staff participation in a task group within ASTM F-15.17, which is Carriages, strollers, walkers and stationary activity centers. ASTM issued four ballots covering 25 items since December 2011, and finally published the latest version on April 16, 2013, just last week. It should be noted that all of the recent changes to ASTM F-833-13 were developed over the past two years by the ASTM stakeholders with staff participation. Current slide shows the recent changes that were incorporated into the standard. I will go over these changes shortly. Incident data. Staff is aware of four fatalities, 359 injuries and 844 non-injury incidents involving children under five years of age that occurred from January 1, 2008 through December 31, 2012. Now let's go over the fatal incidents. In the first fatal incident, a four-year-old male crawled into a stroller that was in an unlocked open position, which then collapsed onto his chest, resulting in compressional affixation. In the second fatality, a five-month-old boy was found hanging by his neck between the car seat of a travel system and a metal bar under the cup holder tray. The third fatality involved a 20-month-old boy who died when the stroller in which he was sitting fell into a bay. The stroller, with the victim still harnessed inside, was later found in the water. And the fourth fatality involved a five-month-old boy who died from mechanical affixation after his head became entrapped between the tray and the seat of the stroller. This unit was previously recalled, however, had not been retrofitted with the repair kit. The 1,207 reported incidents were analyzed to determine 17 hazard patterns. The highest number of incidents were associated with wheel issues, followed by parking brake and lock mechanism. On the other hand, the highest number of injuries occurred due to hinge mechanisms, followed by wheel issues and lock mechanism. Broken wheel or rim, wheel detachment, issues with wheel lock and stability, and burst tire, caused 429 incidents involving 52 injuries. Injuries included two hospitalizations for a collarbone fracture and a head concussion. ASDM F-833-13 includes a new performance requirement to address detachment of the wheels and swivel assemblies. This is the first requirement that verifies the strength with which wheels are attached to the stroller. In addition, new warning labels are required for products of the removable wheel fork assembly to alert the user to check that wheel is securely attached, as well as to lock the front wheel before walking fast or jogging. The second highest incident category includes parking brake malfunction or brake assembly problems. This category includes 8 injuries resulting in lacerations and bruises. A more stringent performance requirement and associated test were added to the standard in which the test is performed 5 times, with a force increased approximately 50%. Next category includes incidents related to lock mechanical issues resulting in a stroller collapse. There were 42 reported injuries including two hospitalizations for a skull fracture and amputated finger. This category also includes one fatality that was discussed previously where stroller collapsed onto a child resulting in compressional affixiation. A modified test requirement has been developed by staff and the subcommittee which increased the force applied to the stroller handle by 50% and also increased the number of repetitions. Staff believes that these updated requirements will significantly reduce the hazards associated with weak lock latch mechanisms as well as parking brakes. Restraint issues such as breakages, detachment or cases where the restraint was unbuckled by the child resulted in 83 incidents including 29 injuries, mostly due to falls. Figure on the slide shows a single push button that resulted in child unbuckling the restraint. A new performance requirement and associated test has been included in ASDMF 833-13 to address this hazard. Hinge issues. Hinge issues were reported in 75 incidents resulting in 72 injuries involving both 2D and 3D strollers. This is the highest injury rate of any stroller hazard category. Reported injuries involved pinched, lacerated or amputated fingers including one hospitalization. The previous versions of the standard addressed scissoring, pinching and shearing hazards but only for a static environment of a fully erected and locked stroller. Incident data show that most of the hinge related injuries occurred when a caregiver was unfolding the stroller for use and the child was climbing into the stroller meaning in a partially erected position. Therefore, a new requirement addressing the hazard during the unfolding action had to be developed. ASDMF 833-13 now includes a requirement addressing the 3D fold strollers but it still fails to address 2D strollers. A test method had been developed by CPSC staff and ASDM to address 2D strollers. Staff recommends adding this balleted requirement to adequately address scissoring, shearing and pinching hazard associated with folding hinges. Structurally integrated related issues such as malfunction of certain parts and components including the frame, crossbar and seat support resulted in 63 incidents and 16 injuries. One hospitalization occurred due to bleeding gums. ASDMF 833-13 contains performance requirements that contribute to the general evaluation of structural integrity. These requirements include latching mechanisms, parking brake requirements, static load, stability, restraining system and impact test. Staff believes that the current requirements associated with structural integrity are sufficient and therefore does not recommend any further changes at this time. Stability and tip over issues resulted in 58 incidents and 24 injuries. Performance requirements associated with stability have been strengthened in ASDMF 833-13 to account for strollers that have rearward or swiveling seats that can face multiple directions. In addition, testing for stability requirements has been modified so that the test is executed in the most severe manner possible, resulting staff believes in a more stringent stability performance requirement. Clearance issues resulted in 38 incidents. This category includes clearance between seat and handlebar, basket, canopy, tray or frame, the car seat of a travel system and handlebar and wheels. Two fatalities were reported in this category which were previously discussed. This category also includes 19 injuries including head and limb entrapments. In addition to the pre-existing requirement associated with evaluating the gap between the seat and front tray to prevent head entrapment, ASDMF 833-13 requires a new entrapment test with a car seat on a stroller or convertible carriage stroller. This additional requirement addresses the fatality scenario in which a child was found suspended between the foot end of a car seat and the cup holder tray. Staff believes that the performance requirement and the test methodology are adequate if you would like we can demonstrate how the fatalities occurred in these two cases. The cup holder was much lower in that actual model and so effectively the child... There were 35 incidents involving a car seat detachment, inability to lock or tip over. Five injuries were reported. The current standard requires that strollers with a rear-facing car seat meet the latching general requirement and performance requirements for parking brakes, static load, stability and tip over. No commission action is recommended at this time but staff will continue to monitor incoming incident reports and work with ASDM to develop these tests further if necessary. Canopies. Canopy related issues such as canopy fold causing finger injuries, a scenario similar to the picture on the left, and cords attached to the canopy causing a strangulation hazard such as the picture on the right and material problems associated with choking hazard resulted in 24 incidents including 18 injuries and one hospitalization for amputated finger. Staff has developed performance requirements with ASDM stakeholders to address the scissoring, sharing and pinching hazard of a canopy pivot and cord and strap strangulation hazards both of which are published in ASDM of A33-13. Handle bar breakage and detachment resulted in 21 incidents including 6 injuries, one hospitalization for an amputated finger. Seat or fabric problems such as fabric tear resulting in head impact with the stroller frame were associated with 19 incidents including 4 injuries. Sharp points and edges resulted in 16 injuries and 2 non-injury incidents. Tray breakage or detachment resulted in 14 incidents including 11 injuries mostly to the fingers. There were 40 incidents with miscellaneous problems resulting in 15 injuries. This category includes cases where strap or logo detached causing choking hazard as well as rust or lead. The current standard addresses most of the hazard patterns identified in the incident data. Staff does not have further recommendations at this time. A total of 32 reports lack sufficient information to determine the cause of the incidents. One fatality which was discussed previously involved a drowning child who was found in the bay still harnessed to the stroller. There was one hospitalization resulting in a child falling into a lake as well as another hospitalization involving a child falling out of a stroller. Without details regarding the specific nature of the failure modes, staff cannot recommend any actions to address these incidents. Staff believes that the new changes to the parking brake and sistering, pinching and shearing performance requirements will address some of these incidents. National Electronic Injury Surveillance System, NICE injury data is used to estimate the stroller-related injuries. An estimated total of 46,200 stroller-related injuries were treated in U.S. hospital emergency departments over a four-year period from January 2008 to December 2011. No deaths were reported through NICE. Most of the incidents were related to falls based on the narratives. In addition to the incidents involving children, there were reports of incidents to older children and adults. Strollers are not self-propelled and remain stationary until pushed by a person other than the occupant. Caregivers are also involved in setting up the strollers such as folding and unfolding, removing from trunk or pumping air to the tire. This involvement requires a different set of interactions with the stroller and poses various risks. There were 78 reported stroller incidents that involved children older than four years of age and adults. 72 incidents involved users age 17 to 64. A total of 74 injuries were reported. 50 injuries involved fingers, hands and toes. 20 of these injuries were moderate and severe. The requirements added or improved in ASCM f-833-13, combined with the staff recommended change, should address some of these injuries and incidents. Staff will continue to monitor incident data and recommend further action if necessary. Staff reviewed mandatory and voluntary standards from Canada, the European Union and Australia New Zealand as part of the rulemaking process. Strollers and caregivers are regulated products in Canada and must meet the requirements published by Health Canada. Their regulation does not have head-entrapment, buckle release or dynamic assissoring, sharing and pinching test. Restrain system requirements are severe. The stroller standard in Europe, published in 2012, is EN1888 and it also does not have requirements addressing head-entrapment for strollers. Buckle release or dynamic assissoring, sharing and pinching. The standard employs fatigue tests to evaluate the durability of attachment points and locks and latches. The standard that covers stroller safety in Australia and New Zealand was published in 2009. The standard does not have head-entrapment or dynamic assissoring, sharing and pinching test. The standard employs fatigue tests to evaluate the durability of attachment points and locks and latches similar to those found in EN1888. As can be seen, none of these standards have the head-entrapment on a travel system or a dynamic assissoring, sharing and pinching evaluation of the folding hinges. Staff believes that the current ASD-MF833-13 standard is the most comprehensive of the standards to address the incident hazards. Nevertheless, some individual requirements in international standards are more stringent. The current hazard pattern identifications based on the data reported to CPSC do not necessitate adopting these more stringent requirements. However, staff will continue to monitor the hazard patterns and recommend future changes, if necessary. As mentioned before, the highest injury rate of any stroller hazard category arises from assissoring, pinching and sharing at the hinge link of 2D and 3D strollers. ASD-MF833-13 now includes a requirement addressing the 3D fold strollers, but it still fails to address 2D strollers. A performance requirement and test method similar to the 3D stroller requirement have been developed by CPSC staff and ASD-M to address the 2D strollers. The developed language has been balloted several times and refined. The latest language is contained in ASD-M ballot F15-301-6 and was balloted in February of this year. It received one negative and therefore could not be published in ASD-MF833-13. The negative vote was discussed and withdrawn at ASD-M stroller subcommittee meeting held two weeks ago. Staff believes that the 2D requirement will be published in the next version of the standard. Now we would like to demonstrate to you how the 2D fold requirement will work. So the requirement is you can't have holes that will, if it emits the small probe, will not allow the standard situation there. So what we have, you place a stroller in an unerrected position and then you move it towards the erected position. So that's the dynamic component of the pinching and sharing test. So in this particular case, we have a pinch point here as this latch, this is the latch portion here. It's kind of dark as you can see that. As that comes in to, comes home, it creates a pinch point. So in this case, you know, that particular one would not pass. However, a lot of strollers will have issues with their hinges in general. And this one is actually fairly close to being just fine. So this is not one of the most egregious ones. We'll look at a 3D one here to show you a recalled case. In this case, we have a saddle hinge, which right here. So as that comes up and comes close, especially if an adult then steps on this as a child's hand is there, this is where we get a lot of the crushing incidents. So to summarize, based on the incident data and anthropometric dimensions of the child occupant, staff with the ASDM task group defined an access zone that is easily accessible by a child. Then the hinges that fall into this access zone are evaluated from partially erected position to fully locked position. Staff believes that the ASDM of 833-13, combined with the 2D fold requirement, should significantly reduce the risk associated with hinges. Between January 1st, 2008 and December 31st, 2012, there were 29 recalls involving 6.82 million strollers and 15 different firms. A few of the reported injuries were to adults. The hazard patterns identified through the compliance data review leading up to the recalls are consistent with the patterns identified by the strollers team through review of the epidemiology data and include strangulation hazard, finger amputations, brake failures, chalking hazard and fall hazards. Now I will go over the small business impact of the staff recommended strollers standard. CPSC staff believes that there are currently at least 86 suppliers of carriages and strollers to the U.S. market. 51 are small domestic firms, including 26 manufacturers, 22 importers and 3 firms with unknown supply sources. The direct impact on the small domestic manufacturers could be significant in some cases, especially if they do not conform to the current voluntary standard. This is due to their low revenues and that the cost of meeting the proposed rule could be high relative to those revenues. The rule could also significantly impact some of the small domestic importers. Again, many have relatively low revenues and limited product lines outside of strollers and stroller accessories. Staff is recommending an 18-month effective date. Disrecommendation would spread the cost of compliance over a longer period of time, mitigating the impact on all firms. However, staff is requesting comments on their appropriate effective date. Finally, staff recommends that the Commission publish a notice of proposed rulemaking that would adopt ASDM F-83-13 with one modification, adding the most recently validated to the requirement ASDM F-15-13-01 item 6 to address pinching, shearing and cessering hazards while the stroller is being unfolded. Staff also recommends an effective date of 18 months following publication of the final rule. This concludes our presentation. Before I turn off the microphone, I would like to acknowledge the ASDM subcommittee for the amount of work that was put into the revision of the standard. And also I would like to recognize the staff members who have worked on this project over the last two and a half years. And they are Jill Jenkins, Economics. Patty Edwards and Jake Miller from Engineering Sciences. Angie Chin and Rizana Chaudhury from Epidemiology. Jonathan Midget from Hazard Identification and Reduction. Stefanie Marquez and Suadwana Nakamura from Health Sciences. Greg Ray, Laboratory Sciences. Mike Lee, Office of Compliance. And Hyann Kim, Patty Pulitzer and Leah Wade from Office of the General Counsel. Now the stroller team will be happy to answer your questions. Thank you. Well, thank you all for excellent presentation and for the team who worked on this. I've thanked you all already for all of us, but this was a significant rule with many moving parts and different stroller designs. And we thank you for working with ASTM so closely and delivering the package to us today. I have a few questions and as well as the other commissioners, we have a 10-minute limit on our rounds and then we can ask more if we don't cover them in the first 10 minutes. The first one is I understand the requirements to address scissoring, shearing and pinching hazards associated with the 2D stroller is currently being balloted by the ASTM. And do you anticipate that the subcommittee, ASTM subcommittee will recommend the inclusion of this requirement in the rule? And if so, what do you estimate the time that this will happen? The 2D stroller requirement was balloted back in February and it received one negative vote at the time. Therefore, it wasn't included in the ASTM F833-13 version. However, ASTM subcommittee meeting that was held two weeks ago discussed the negative vote and the water withdrew his negative. Therefore, it's a clean requirement now and we anticipate that it will be published in the next revision of the standards, which I anticipate in early summer. Early summer. You have recommended the 18-month role and you alluded to in your comments that this is because so to mitigate any economic impact on shoulder manufacturers. Can you elaborate on this and the reasons why you think the 18-month is necessary? Sure. Well, there were a couple of concerns staff considered before making this recommendation. First of all, staff acknowledges that there's a substantial amount of changes that took place in the standard. And there may be suppliers and manufacturers who were not aware of the ASTM standard development work. So they would only be aware of the changes after the standard is published. In addition, clearly you have seen the amount of changes that were in place and the complexity of stroller design. JPMA's letter that was sent last year in the, as well as the last round of the ASTM balloting process, generated comments in terms of the product development timelines, which is aligned with an average of 18 months. And also, we would like to consider the impact that the standard will have on small businesses. And we believe that it is reasonable to have an 18-month effective implementation date to both produce a safe, effective stroller, which will meet the new requirements, as well as minimize the impact on businesses. According to the briefing package, the staff leads to the ASTM F833-13 with the addition of the requirement to address scissoring, shearing, and pinching hazards associated with 2D strollers is the most comprehensive standard really in the world to address fatalities, injuries, and incidents we've seen in strollers from our data. But nevertheless, some requirements and international standards from Canada, Europe, and Australia are more stringent. Can you talk about the more stringent standards from those jurisdictions and provide some insight on those? I know you went through those that were less stringent, but tell me some of the more stringent ones and why we did not incorporate them in our standard. Sure. There are a couple of requirements that are more stringent. One would be a 5-point restraint system requirement in Australia, as well as the European test, which basically rotates the stroller 360 degrees, which encourages the use of 5-point harnesses. However, our incident data did not really show a hazard pattern where the child was falling off the stroller just because it had a 3-point seatbelt. The majority of strollers actually, in fact, have 5-point restraints. However, it's not required in the ASDM standard. What we wanted to focus on was what's the major hazard pattern that we see in this category. And for restraints, it is the child unbuckling, the restrained and rescuing herself or herself from the stroller. So that is what we wanted to focus on rather than strengthening an already strong requirement. Another one is a rolling road test, which was in Australia, which is, again, a stringent test, but we did not see the need of strengthening it because of the lack of the hazard pattern. However, we are proud that none of these international, basically, standards have a dynamic folding and a scissoring-sharing pinching hazard that we are addressing now. In addition, they do not have the head-and-trapment on a travel system that we are addressing now. So we are basically looking at reasonably foreseeable misuse cases where the other standards didn't look. I know when I visited stroller manufacturing plants in China, they demonstrated strollers on a treadmill with bumps that go round and round for days. And also you see workers on a track going round and round and pushing the stroller to demonstrate endurance. We do not have that endurance standard. Up the workers? Well, both. They have to go. That's good. Thank you for making sure my modifiers lined up. But it's the endurance of the worker and the stroller. But anyway, so this, we did not include in ours. And just now that we have you to answer these questions, just why don't we have an endurance test? I don't think it's necessary, Greg. No, it's not necessary. Okay. We have other means for... Yes, we do. We have other means, such as weight on wheels and 100-pound weight to ensure that the wheel does not come off. The static load test, correct. The static load test, there's the wheel retention test, there's the curb impact test. I'm forgetting five or six, I'm sure. But what we do across several different standards, requirements that are already in the standard, they do with one very large test. The test is, I'm having my notes here, it's 64 hours long, and they run their stroller at five kilometers an hour for this full 64 hours. And like you said, there are two or three inch bumps spaced unevenly. So it's a fairly, you know, severe test. But it's also a 64-hour long test, which is, you know, would be a big, it would be a big step to require that, where we had not done that if we didn't need it. Thank you. I wanted to give you all the opportunity to demonstrate that we had so many other tests that really ensured the durability of the stroller. Okay, that's all my questions for now, Commissioner Nord. Thank you. First of all, let me associate myself with the Chairman's initial remarks and thank the team for the hard work that went into this briefing package. The hard work is obvious. The briefing package really does focus on a product that is in the home of every single child, I think. So it's an important product and it is widely, widely used. However, because the briefing package also included injury rate information, that tells us that the injury rates for this particular product are on the high side of the durable infant products that we're looking at. And I think that's a very important piece of information for the Commission to have because it does assure us that this is a product that we need to be focusing our attention on. So Greg Rogers and his team, thank you very much for including that information for the Commission. Now, the, as I understand it, the staff is including or recommending a new requirement dealing with the 2D strollers and the pinching, scissoring, and shearing hazard that is in the access zone with respect to those strollers. What proportion of the incidents that you saw occurred and are addressed by this new requirement? A very good question because there were 75 incidents associated with the folding hinges. Right. And 72 injuries. Yes. 50 of those injuries occurred on a 3D stroller. However, 47 of that 50 belongs to one brand. And only the other three are from different brands. The remaining 22 injuries associated with the folding hinges are spreading to 2D strollers. We do not have a dominant brand that covers that 22. So it is a more widespread issue when you look at the 2D strollers itself. So it's a more generic thing. Okay. That's very interesting and helpful information, which leads to my next question. And that is in the briefing package, it indicates that many of the changes that are in the most recent version of the standard are changes that were recommended by the CPSC staff to ASTM. And I'm wondering if you could address why that is true. Did ASTM not have the same information that we have? Why is it that we are bringing the information and recommendations to this group of experts? It's my understanding that when the first consultation process commenced in early spring 2011, we shared with them the hazard patterns that were identified by the staff after review of the incident data. So that initiated the discussion on what they should be focusing on. And incident data, such as the folding hinges, weren't really difficult to convince because the data is there and there are associated injuries. Therefore, ASTM subcommittee was willing to work with the staff to address these issues. But it was a collaborative process. Sometimes the staff proposed a test method, for example, which would address the issue better. Sometimes we helped them with certain data that was collected, the anthropometric data or strength data. And sometimes our engineering staff basically reviewed many strollers, evaluated many strollers, and came up with numbers that were very helpful for the ASTM subcommittee to take into consideration. So it was a collaborative process. It wasn't like, here is the requirement that we think appropriate and adopt this. And again, the requirements were validated four times and it covered 25 items. So the language has been refined in many of these requirements to get to this final stage. Well, the collaborative nature of the process is really important because we have to be assured that ASTM is on their game if you will and well-positioned to identify and address hazards that are coming up without our pushing them. And we also don't want ABSC staff inappropriately pushing them either. So to the extent that this demonstrates a collaborative process that worked, then that's a very good development. You mentioned the pinching, scissoring hazard as one that addressed bulk of the incidents. Do all the other changes that are in the current ASTM version, are they supported by incident data that we either brought to ASTM or they were aware of? Yes, for example the wheel detachment issues that caused, I don't exactly have the number, but the wheel detachment caused probably close to 50% of the wheel issues which are going to be addressed with the new requirement. And similar to the parking brakes, the canopy fold that causing again finger amputations. So VR, I believe you're addressing the bulk of the hazard patterns with these new improvements, either new or improved requirements. I read with a great deal of interest the regflex analysis and was struck by, I assume all of us were struck by the high testing costs that were discussed in there and the pretty large redesign costs that are anticipated. The briefing document says that it could cost up to $1,000 per model to test these things for one sample. How many samples do you anticipate would have to be tested in order to go through the tests that are specified in the briefing package? Could you do it with one model or are there destructive tests? Actually there was an addition to the standard which I didn't mention, but requires a certain testing order. So that was actually put into place by the ASDM subcommittee to make sure that minimum number of strollers are going to be tested to accommodate to meet this requirement. What would that minimum number be? I don't know. I don't know how many because it will depend on the result of the previous test. So if they can use the same stroller for the consecutive test then that's fine. But if it breaks like the strollers with the maybe stability? Right. I mean there are only a couple that could truly damage the stroller. If one... And so once you have a failure you would probably stop and go back and fix things. Now assuming, I mean I know most of the manufacturers they do a lot of testing in-house and so they are reasonably assured that it's going to pass when they send it to a third party lab and that's just good business. And so they should only have to send one or two strollers. They should not be five, six, ten. I don't... Actually we don't have the exact number what would require it but it should be fairly small by the time it gets to a third party lab. Okay. So if the one stroller goes through the sequencing of tests and passes it in sequence by the end it probably will be destroyed but only at the end, not during the middle of the process. It will definitely be worn. Okay. Then what should I take from this discussion with respect to what would be a representative sample of strollers to be tested? Frankly we'd have to get back to you. We'd have to call some contacts in the manufacturing groups and the third party labs to see what they usually do. I don't have that number personally. Okay. That's an awfully important number because that really does drive the economic analysis here. Now the chairman asked about the testing that is being done in other jurisdictions to comply with other standards. And Greg, thank you for that comprehensive description of those tests. You indicated you didn't think those tests were necessary to demonstrate the safety aspects of or attributes that you were interested in. I'm wondering whether those tests would however be viewed as an equivalent. So if you do, if you have the Chinese workers go around the track how many times would that get you to the same place that this test that we have specified would, albeit in a much more burdensome way? Does it demonstrate the same safety attributes? It might, but I think it will depend on or it is going to be the result of work between ASTM and other standard organizations to sit down and match these certain requirements and eventually agree on, okay, if this stroller passes EN standard in this aspect, which is more stringent than the ASTM, then we will accept it as an equivalent. Otherwise, a JPMA certification may not work, right, because it has to meet the ASTM requirements. So ASTM comparable requirements should be developed or should be, I guess, agreed upon for that work to happen. And I think that would be great, but I'm not sure whether CPAC staff can do anything about it. Well, it would be great. Thank you. Mr. Adler? Thank you very much and I want to join in congratulating the staff on a superb job and for very, very hard work. I do want to express commiseration with Greg about the fact that our Michigan Wolverines lost to Louisville in the basketball championship. But as I've said, I actually slept like a baby after the game, sleep two hours, wake up crying, sleep two hours, wake up crying. I also find it intriguing, I don't know about enjoyable, that I don't think a day passes when I don't find some way of disagreeing with my esteemed colleague, Commissioner Nord. On this one, I would say that one person's persuasion is another person's push, but I like the idea of the staff being very actively involved with ASTM, persuading folks to look at data, and we are a data-driven agency, and that's exactly the way to do decision-making. And so if you read the GAO report, one of the things the GAO report said was they wanted the commission to be more actively involved in the process. And I think it's a great process. I wish all of our rulemaking in so many respects followed the 104 model. So that's just my little editorial at the moment. Page nine, just this is a question about trace. And by the way, I apologize for not being able to sit down with you all beforehand. You've answered most of my questions, but I thought I would ask about trace. One of the things that was intriguing about trace is very few injuries, very few incidents, but of those incidents, a very high percentage of injuries. And I guess the question is, did you feel it just didn't rise to the level of being serious enough to take action with respect to trace? Right. As you just indicated, it ended up having 14 incidents, but involving 11 injuries. So it has a high injury rate, but in the overall scheme of the incident data we had, we really could not bring it up as another issue to address at this time. However, this is in our future action item. And Trey Hinges, we would like to bring it up to the subcommittee to address the issue. It's a difficult problem because this is a completely two separate units coming together, so a fabric cover would not work for this, for example. A redesign will be necessary, but we will bring this issue up. Yeah, and I would just make one point that data-driven doesn't mean that you need injuries and fatalities before you act. On the other hand, if this has been a configuration that's been around forever, then you probably know what the actual picture is. But to the extent you have engineering data that points in a particular direction, you've got a brilliant engineer to help you, I would say that those are issues we should address. I did have another question on page 11. You discussed product recalls, and this is page 11 of the NPR. And this is an issue I'd raised before. We have recall data, and then we have injury incident data. I'm not talking about the NICE data, but the 1,200, what was it, 1,207 incidents. Were the incidents associated with the recalls incorporated into that 1,200 number? There is an overlap, but there is no one-to-one match that we could do, and there are several reasons for this. One is that a portion of the compliance data lacks details in terms of individualized incidents and how they happened. Sometimes manufacturers may provide compliance reports saying we have a summary of 10 incidents associated with this roller, but epidemiology cannot investigate it further because it's just the summary number. In addition, the time frame is not an exact match either. The compliance reported recalls that were administered between 2008 and 2012, which is the incidents' occurrence date that the epidemiology department pulled. However, the compliance recalls are referring to certain incidents that occurred prior to 2008. Actually, compliance data refers to five fatalities, but they all occurred prior to 2008. They all occurred around 2006, so even though the recall date was later, the referred fatality incidents, the fatal incidents, occurred prior to epi-data pulled the numbers. So there you see that there is some overlap, but that doesn't necessarily exist for every compliance incident. Okay, that's the clearest answer I've ever gotten on that, and it makes infinite sense, but then what you're saying is in effect that 12007 is a minimum number, and if anything, it's low compared to the actual number of incidents. That's correct. One thing I want to mention though, our focus was to identifying hazard patterns, and none of the recalls created a different hazard pattern that we didn't look at. So that was our focus. Did we miss any hazard patterns? The answer is no. Okay. You've shown me how kids can get injured through the locking mechanism, but I can't visualize what a company would do to address it. I know it's a performance requirement, but would they just put shielding around the areas where it locks? Now here's another part of the question. Is there a way of making it very obvious when it locks so that people can look for an orange flash or something like that when it locks, or there's a loud sound when it locks? All are correct. Okay, good. I've never had anybody say that to me before. But the warning label for the front wheel is right in the eye view of the caregiver who pushes on the handle. So we do have a location-specific warning label to warn them that the front wheel has to be locked. Okay. With respect to the restraint mechanism, this is one where I can't visualize what we're doing. It says a new performance requirement and test procedure to help prevent the child unbuckling the harness straps. And I seem to remember from the briefing package that you need two separate motions now to do it, or it's very resistant to... Two options. It could be a single push button, but that push button has a force requirement, which is actually taken from the NHTSA's infant car seat requirement. That should help reduce the risk of child unbuckling by just pushing the button. The other is a double-action release mechanism. The manufacturer can either have a single-action release, which will have a force requirement, or a double-action release mechanism. Yeah, the double-action reminds me of child-resistant closures, and I like the reasoning by analogy there. Oh, back to the difference between the foreign standards and American standards. Now, the term I would use was a fatigue test. Was that the same thing as the person rolling the stroller around for 30 hours? Right, it's 64. It's, I think, the official name is a dynamic durability test. Okay, that's much fancier than fatigue tests. And the reason that we didn't do it was that we couldn't relate that to incidents, and because it would seem to be extremely expensive to operate. Am I correct in that assumption? Correct. Okay. I think those are my questions for the moment. Thank you. I just have a few questions, too. And it has, one of the first questions is universal strollers. There's this universal stroller that supposedly, on which all child car seats can fit to make a stroller. So it's the bottom parts of stroller, and you take the child seat and put on top of it. This is not covered. The universal stroller is not covered in this rule, right? Right, there are, I guess, different terminology. The universal stroller can also mean that it's a modular product, so the manufacturer would be selling a universal frame along with a Bessonette, which then would be exchanged with a regular toddler seat in a regular stroller. But it is within the same manufacturer model. So one manufacturer basically is creating a customizable stroller. These are covered. What is not covered is universal stroller frame, which is sold without a seat. And the manufacturer's universal stroller frame manufacturers claim that they can accommodate many different brands in fun car seats. This is an issue we have been thinking about for a while. Note that the number of incidents are not that high. There are eight incidents with no injuries. Or the incidents we have seen are usually like wheel detachment issues, which should be covered ideally in a stroller standard. The issue comes up from the testing perspective. The testing lab would need to test different brands of car seat. How would they determine that the stroller is meeting the standard without testing all models that the manufacturer claims that would always exponentially increase the testing cost for these stroller frames? Then JPMA would not be able to certify if it is not tested for all compatible car seats. So that creates a logistics problem as well as a cost issue. Greg and I went through certain testing procedures to come up with a draft test plan. For example, we would use maybe the most honorous combination in certain cases. Veal detachment type of issues should be easily addressable without increasing the cost. So this is an issue we will bring up again in addition to the tray in the next version. So we just continue to monitor the incident rate to see if there are injuries and if it needs a rule, but the jury is still out on that. I looked at the briefing materials and you all pointed this out to me too. There was one model with a jump seat and it looked like it was a 3D stroller that almost looked like an umbrella stroller and there was a jump seat out front. Is that model still on the market and why would you have the jump seat and then what about the comfort of the child behind the jump seat? Those are three questions. Yes, actually there were two recalls that were associated with jump seat or booster seats that just as you described that there is a seat in the middle kind of outside or in front of the other two children or two children seats. I am not sure if it is a comfortable riding position for long rides but for a temporary solution for a short ride maybe it is still acceptable and they are still in the market. It had a retrofit solution, not a refund solution in the recall announcements. There was a tandem seat side by side in a jump seat up front so it was designed to hold three children. And the older child would go up front or was it designed for the younger child up front? I am not sure. And what is an example of a swivel seat in a stroller? Yes, there are seats. The manufacturer's recommended position of getting into the stroller doesn't necessarily mean that it has to face front. It could be on the side and if there are two seats facing each other again there are swiveling options for those seats and the new requirement for testing for stability will cover in terms of how the child will climb into the stroller and whether it changes anything in the stability by testing the most severe manner possible as well as all positions that are recommended by the manufacturer would be tested. For structural integrity there is an injury when a stroller seat ejected. How does the stroller seat eject? Yes, this was an incident where just as I mentioned there is the manufacturer provides a frame as well as a Bessinette looking seat for the younger child and when the child grows on that Bessinette will be replaced with the regular seat. This was an incident where this stroller frame basically accommodated the flat Bessinette but that Bessinette detached from the frame. Okay. Injected. Are all strollers a three wheel or four wheel? They could be either three or four. So tricycles though are not included in this? No, tricycles have an ANSI safety standard. Tricycles are self propelled so by definition it is outside the scope of stroller standard. I understand the work is continuing to improve the stroller standard so we will put this NPR out and the ASDM will continue to work on the stroller standard as will we. Can you elaborate on these issues and just tell us what issues are still being considered by us or ASDM? Currently the only outstanding item is the 2D stroller requirement which we believe it will be a part of the next revision of the ASDM standard. Okay, so there was only that one that's being balloted. It's been balloted. That's balloted. By summer it will be, we will have approval of that. Right. Okay. Thank you. I don't have any other further questions. Commissioner Nord. Thank you so much. Going back to the incident data in the briefing package it talks about hazardous environments in or around the stroller were considered to be within the scope of what you were looking at and there's a footnote in the briefing package that says all incidents where the hazardous environment in and around the stroller resulted in fatalities, injuries or near injuries were considered to be in the scope. It's not clear to me exactly what it is you're talking about and why would the external environment impact the performance of the product in a way that would require us to address that. Do you want to get back to me? If I am not mistaken the hazardous environment might mean that the child is climbing into the stroller but not exactly sitting in the stroller. So since most of the folding hinge incident scenarios included child outside the stroller I believe that is what it meant to cover. So it's the child's interaction with the stroller that you were talking about. That clarifies that if that's what that meant. With respect to the strollers that are travel systems and that use a car seat how does this standard relate to the federal motor vehicle standard and will compliance with this standard in any way complicate or hinder compliance with that standard? Our expectation is that car seats need to meet the NHTSA requirements and to the extent that there are also handheld carriers we recently published the NPR regarding handheld carriers with certain requirements that were in addition to the NHTSA requirements. I think they primarily addressed handle bar issues and the latching mechanism and some warning labels. So to the extent that a stroller has a handle carrier as part of its requirements they would need to meet the handheld carriers. Well for example the straps and the locking mechanism all of that does that relate in any way to what NHTSA requires? Well that was in addition to what NHTSA requires in the handheld carrier standard. But with respect to car seats in a car that is used in a car they need to meet the NHTSA requirements. To the extent that there are additional requirements for handheld carriers under our standard including the handlebars and the hinge mechanisms. I should have said hinge mechanisms on the handheld carriers they would have to meet those. In addition for strollers they would need to meet the stability requirements so that the handheld carrier wouldn't fall off. That doesn't relate though to the car seat thing. You don't see any issues about either complicating NHTSA requirements or conflicting with or duplicating NHTSA requirements. I'm assuming that in these things the NHTSA requirements are I want to say primary but are considered respected. Yes but there's a separate provision under the ASTM standard F833-13 which specifically addresses car seats. So they were very mindful of the requirements for car seats in particular and any additional requirements staff has been careful to not interfere with or supersede or override NHTSA requirements that any additional requirements were in addition to not in lieu of. The briefing package indicates that in addition to these requirements the product would be tested for lead and for phthalates. I see the logic of phthalates testing perhaps for the trays. Is there a testing requirement beyond that for phthalates? I think that phthalates and lead have been in effect since 2008 and whether or not phthalates testing applies depends on the product and the manufacturer's intent because the child care article is defined as a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age three and younger. So to the extent that the manufacturer intends for the child to feed or to sleep is something that the manufacturer would determine. To the extent that you see some of these strollers with food trays it would seem as though they intended to feed the child. So many of these food trays though however can be disengaged for easy cleaning so to the extent that they might be considered a child care article in and of themselves may be a reasonable interpretation. Thank you. And then one final question. I'm really intrigued with the whole notion of trying to get some consistent testing requirements for these products as well as others. Do you see any downside in including a question in this NPR asking about a testing equivalency to the extent that the more I don't want to say rigorous but the more time consuming test that one of the other jurisdictions requires to the extent that that does address the same issues would it be helpful to at least start collecting that information in this NPR? Or is there a downside to that? I think that is something that all manufacturers are mindful of with increasing globalization. So I would assume that that is something that all the ASTM committees are working towards and with respect to this specific NPR were focused mainly on getting to a final standard that addresses many of these hazard patterns but I don't see any problem with asking that question. It's just more something that I would think would par for the course. Thank you very much. Mr. Adler. More of an observation than a question but I was just reflecting on the fact this must be one of the most complex standards this agency has ever worked on because when you look at these things they come in an infinite variety and they roll and they fold and they snap and all of those are potential landmines for some kid to get injured and it's amazing that you've done such a great job of looking at the incident data working with ASTM to come up with what strikes me as a very complex standard for a very complex set of risks and I just have to sit back and say job well done both for staff and for the ASTM committee. I think everybody should feel very proud of themselves. All right. This obviously concludes our questions and we thank you all for excellent presentation and answering our questions and again for the whole team for working on this outstanding package. Our meeting is adjourned. Thank you.