 Good morning and welcome to this public meeting of the United States Consumer Product Safety Commission Today we will consider one agenda item a draft final rule regarding a safety standard for magnet sets We'll start with five minutes for each commissioner to ask any questions of staff regarding this rulemaking package Sitting before us today and available to answer questions are Dr.. Jonathan midget children hazards team leader in the office of hazard identification and reduction and Mr.. Andrew Camaros attorney in the office of the general counsel I apologize last time by the way. I referred to you as being in the Attorney General's office, which would have been accurate from a prior lifetime of yours I Do not have any questions for staff Commissioner Adler No questions no opening statement. Thank you, sir. Commissioner Robinson Thank you, mr. Chair. I do not have any questions, but I just have a few comments that I would like to make Shortly after I became a commissioner last year I was introduced to the issues related to small high-powered magnet sets my initial reaction was that this was a very complicated Issue we knew that although these magnet sets were initially sold to children by the time I arrived as a commissioner They were being marketed as adult products or adult dust toys marketed to adults with adults buying them and They were not we knew they were not hazardous to adults because adults follow the warnings and do not swallow them I would quickly learn that the problem was however that what however they were marketed that these were These were items that were being swallowed by young children and by ingested by teenagers and were Making that we're causing very very serious injuries and even deaths These magnets are so powerful that when they get in the intestinal track and when they're when there's more than one They will cause the intestines to clamp together and will cause bowel death and most dangerous is that it's so insidious That the the danger is something the parents don't know about they don't know that the items have been swallowed They don't know that when they when the sipper symptoms come if the parents don't know what's been swallowed And they take it to the doctor even the best of doctors will misdiagnose because the symptoms look just like flu or virus and the Longer those magnets are in there the longer the blood supplies cut off to the bowel and intestines the more serious The injury and the more likelihood of death So I was really struck with how this hidden hazard was something that as I say however Marketed that this was something that needed to be addressed and I've been really struck with The very very active role that the medical community has taken in this rulemaking process It was a pediatric gastroenterologist who first came to us in the spring of 2012 to sound the alarm because they were finding that their members of their Organization were more and more talking about the injuries caused from these small magnet sets in June of 2012 the the NAFSA began members met with the CPSC staff to present their data and January of 2013 we had the first recalls of the small high-powered magnets in an October of 2013 shortly after I became a commissioner five pediatric gastroenterologist from NAPS again NAPS began Came to testify before the Commission and were very clear to us that in spite of all of their efforts to get as much Data as they could both from their membership and by going behind our data here at the CPSC That they were satisfied that what we knew of the injuries being caused by these small magnet sets was simply the tip of the iceberg With only 25% of their members responding to a to a survey They found that there were 481 cases of magnet ingestion over 10-year period and found most informatively that there was a spike a Drastic spike after these small magnet sets went on the market in 2009 of the 123 clinical cases they reported 102 occurred in 2011 and 2012 after these Magnet sets went on the market and when the NAFSA began went behind our nice data and also tried to Make more sense of what we had by way of information They not only found the spike in the incident data after 2009, but they also found Interestingly that there was a spike in the 14 to 17 year age group Which previously did not have documented incidents of swallowing magnets and we now know that that this was in large part Because teenagers or preteens were using these magnets to mimic piercings and then inhaling them The public comments from the medical community have been extremely persuasive We had approximately a hundred and fifty in response to our NPR the majority It's hard to say the majority all but one of these comments from the medical community Was we're strongly in support of us passing this rule and the majority of these comments were submitted by Individuals with personal experience in treating children who either narrowly avoided or actually sustained serious injuries From these medical sets From these magnet sets the report for professional societies that submitted comments to us representing a total of approximately 90,000 physicians in this country. We heard from NAFSA began again the pediatric gastroenterologist the American Society for Gastrointestinal Endoscopy the American Gastroenterological Association and the American Academy of Pediatrics and I was a very impressed by the testimony that was given to us Last October the bottom line is that the Commission's job here today is complex It's also critically important and after reviewing all of the materials prepared by staff Analyzing the public comments submitted by stakeholders listening to stakeholders who presented oral testimony and Participating in the briefing two weeks ago I'm confident that I as well as my fellow commissioners have enough information To make an informed and mindful decision on this final rule for a safety standard for high-powered magnet sets Thank You Commissioner Robinson Commissioner Malerovic Thank You mr. Chairman. I would like to echo the compliments to the entire staff who participated to this rulemaking package Specifically course dr. Midget mr. Cameras. Thank you for the efforts that you put forth Mr. Chairman would this be an appropriate time for a statement or would you prefer later? It's up to you commissioner. We're gonna also have opportunities for closing statements. So it's your choice. I think at that point Thank You mr. Chairman. I think I'll wait for closing statements and leave my compliments as the only initial point. Thank you Thank You Commissioner Malerovic We now turn to consideration of the draft final rule. Are there any amendments? Hearing none. We now move to final consideration. I Move for approval of staff's draft final rule regarding a safety standard for magnet sets and Publication of the same in the federal register. Is there a second second? Each commissioner now has five minutes to discuss the motion commissioner Adler. I have no comments to make about the motion I do have a closing set of comments, but I will reserve them till after the vote Mr. Robinson, I have no further comments Mr. Malerovic nothing on the motion There being no discussion. I now call the vote commissioner Adler. How do you vote aye? Commissioner Robinson aye Commissioner Moherovic aye and I vote aye the eyes are four and the nays are zero the eyes have it The motion to approve staff's draft final rule regarding a safety standard for magnet sets and to publish the same in the federal register Passes the safety standard has been approved and shall take effect 180 days after being published in the federal register We'll now move to closing statements. I struggled with what to say today and I think as commissioner Robinson so perfectly said this is a very complex issue and so I Chose not to go the simple route and to try to recognize the complexities that are involved here During the time that I've been at the CPSC The commission has taken a number of important and uplifting consumer product safety actions One example that comes to mind is when the commission approved a few years ago the publicly searchable Consumer product database for the first time consumers were given direct access to and a voice on Reports of harm related to consumer products that had previously been hidden from public view Today's action is no less important from a safety perspective, but for me at least it feels much more solemn Before explaining why I feel it is important to note that I've not seen a better example of the commission in particular CPSC staff responding and proceeding in a manner true to our mission and purpose The action that culminated in today's vote began with incident reports first a few Then more and finally enough to become a very alarming and disturbing trend In an effort to reverse the trend and address the hazards our staff work through a progression of our authorities We all hoped each step taken would be the least burdensome in the last one needed to address the frightening injuries to children Injuries that have been described as gunshot wounds to the gut, but without sign of entry or exit Unfortunately, the continued prevalence of incidents made pursuing a mandatory rule necessary and so the staff did This was a bottom-up effort Not the result of any kind of congressional or commission level prompting CPSC staff faithfully executed the mission of the agency I would like to take a moment to recognize the members of the magnet sets rulemaking team Dr. Jonathan midget Dr. Sara Garland Miss Kate said me. Mr. Tim Smith. Mr. Vincimodio Dr. Sandy Inkster Mr. Mike Lee Mr. Chuck Smith Mr. Andy Camrose Miss Patti pollitzer From a consumer product safety perspective, this truly is an important day But as I mentioned, it is also a solemn one For me the action we are taking today is accompanied by the tremendous amounts of law And hurt that many have experienced and still will experience Many are facing financial loss whether that be as a result of health care costs piling up From treatment to their children injured by these magnets or whether that be a business and one business in particular Who is in the future is likely to bear the brunt of our regulatory action approved today Many hurt emotionally whether that be from enduring their child suffering from these horrible injuries Or whether that be a business owner grappling to accept an entrepreneurial dream that faces possible extinction I will come back to this particular point Most heart-wrenching of all though one little girl Anika Chaffin was terribly hurt and lost forever. I Would like to read a passage about what happened to Annika or Annie as I understand her family called her This passage is from an email her aunt Lisa to Anna who's sitting here today Sent a message to me and the rest of the commissioners earlier this month Open quote on August 22nd 2013. My sister Amber called me and said Annie was extremely sick She was puking and very lethargic to the point that she could hardly hold her head up Andrew Amber took her to Children's Hospital They diagnosed the flu and performing a strep test after performing a strep test Told Amber to take her home and give her something to drink and some ibuprofen Annika fell asleep on Amber's arm after Amber told her she loved her and Annie said hey mom Amber slid out from under her the next morning August 23rd Carefully so she could get her brothers my nephews ready for school while she was sleeping It was my oldest nephews 12th birthday Amber went back up to check on her because it was so odd. She wasn't up after they left She was cold and hard Amber ran next door to get the neighbor who was a nurse to help She came up and attempted CPR while Amber called 911 The baby was presumably already dead because in talking to the neighbor when she was attempting CPR She had to pry the baby's mouth open and with every compression. There was blood coming out of her eyes nose and mouth He already had modeling on the side of her body My mother called me on my way to work after receiving a call from the police to go to the hospital. I Got there moments before my mother did The police took me into a room as they wouldn't allow more than two family members at a time Within maybe a minute. I heard a whale unlike any I've ever heard in my life And I hope to never hear again, and I knew she was dead. I Could recognize the tone as my mom and sister, but the sound was different that sound still haunts me My sister had to endure questioning from detectives in which they inferred she may have killed her child until the hospital called to say the X-rays of Annika's body. They could see seven spheres could be magnets or batteries We were dumbfounded at first Amber doesn't have watches that would have batteries that shape and she doesn't have magnets Then she remembered the magnets the boys had brought home At some point Annie must have wandered into one of the boys room and found them Saw they were brightly colored and popped them into her mouth Once the autopsy came back the magnets were confirmed The toll this has taken on my family My parents my sisters my nephews my daughter and myself is greater than I can explain with words We can't bring my sweet little niece back, but we can ensure this doesn't happen to some unsuspecting parent again Simple warnings on a box aren't enough My sister never saw the packaging Close quote. We all have fears in life Every single one of us For me the biggest without any question is something tragic tragic happening to one of my boys Every night every night Long after we have put them to bed. I sneak back into their rooms to kiss them one more time As I do that I feel tremendous gratitude that they are alive and Well and that I am so blessed to have the privilege of hearing in the dark of their rooms The soothing and rhythmic sound of their breathing I hug them tight trying not to wake them all the while knowing that as long as I might hang on that particular evening That moment is so rather fleeting And I also know each night that there is certainly no guarantee I will have even one more night to hold on to them tight So as a parent I hurt so much for Annika's family Them as Chaffin your mom Your sister your sons Brody and Sebastian and niece Chloe I am deeply moved. You took the time to drive here from Ohio today I will always think of annie when it comes to this rule And the actions the commission has approved this morning, and I'm so deeply sorry for your loss I recognize as I say this though that this is one of those moments in life Where the striking limit of words to provide any sense of deep and enduring comfort is so perfectly and painfully proven Also in our thoughts is little braille and jordan from louisiana Who had to battle through numerous surgeries as a two-year-old after his intense tests and were perforated Braille in is not alone as many children and teenagers have suffered serious injuries after ingesting these hazardous magnets As many families and the medical community well know To the medical community specifically the gastroenterologist led by Dr. Athos Buvaros The president of the north american society for pediatric gastroenterology Hepatology nutrition. We thank you for your contributions to this effort Including your first person accounts of rushing children into surgery There is of course another extremely important aspect to our action today And I alluded to it earlier I feel the weight of and i'm genuinely sorry for the likely loss of one man's dreams To doubt the power and captivation of dreams is to lose a vital part of our humanity I received an email two days ago from this individual mr. Sheehan Q who is the creator and manufacturer of zen magnets Mr. Q. Thank you for sending your email regarding the rulemaking that we voted on today Here is one passage in particular that I found especially meaningful and moving quote It was in a moment of awe and lucidity that I decided to start zen magnets These magnets fears are a window to a universe of curiosity and inspiration Utterly unlike any other product before it To me an adventure into geometry Photography physical forces and most importantly my own mind As an adult they still bring me the childhood wonder that I once had for much of the world around me These magnets function exactly like they should That they require more care and use than many other products doesn't mean magnets should be feared but that they should be respected closed quote We do not agree on how to address the hazards presented by these magnets But please know I do respect your dream to innovate and to create Some of you who have worked with me might have heard me say from time to time the importance of dreaming big and then even bigger Mr. Q. This is what I would like to leave you with I hope your dreaming will continue and that inspiration will strike again And that there is a path forward that secures for you that elusive childhood wonder but in a way that can endure Some loss tragically is permanent and life changing We bear witness to that today With the presence of anika chaff and family But not all loss and hurt need be At least that is my hope for this process That the rule approved today will prevent future loss and hurt by protecting and preserving Not only the precious health of children But will also provide sufficient space for the entrepreneurial dreams of adults Commissioner adler Thank you, mr. Chairman. Um, thank you for that very moving statement. Uh, mine is much, uh much shorter A staff has pointed out we're faced with the product that's extremely Appealing to children and in fact at one time I remind the world it was marketed as a toy for children But as horrific injuries resulting from the attraction of magnets to one another in children's digestive systems began to accumulate The commission worked with firms that sold these high powered magnets to limit their marketing and sales practices exclusively to adults I think it's fair to say that both the commission and the industry approached this initiative In good faith with the best of intentions with the hope Somehow that children's exposure to high powered magnets could be limited sufficiently To protect these innocent and involuntary risk takers Sadly, despite everyone's best efforts the injuries have continued unabated Several reasons probably explain this first. It's impossible To put warnings on the magnets themselves So many adults have never fully appreciated the extremely hazardous nature of high powered magnets And as we heard sometimes adults never read or have access to the warnings on the boxes Moreover once in a home where young children can observe them magnets have proven extremely And particularly appealing to kids and I want to read an excerpt from the staff briefing package that captures this thought These types of magnets tend to capture attention Because they're shiny and reflect light they're smooth which gives the magnets tackle appeal And these magnets make soft snapping sounds as they're manipulated These properties or characteristics of magnets are likely to seem Magical to younger children and therein lies the problem The staff briefing package also notes that because of their small size And detachability when played with these magnets can easily become loose or lost from the set Thus presenting an unreasonable risk to any child who might find them in short despite everyone's best effort The conclusion that I reach is that if these magnets sets remain on the market Irrespective of how strong the warnings on the boxes in which they're sold or how narrowly they're marketed to adults Children will continue to be at risk of debilitating harm or death from this product I realize there are some members of the public who would wash their hands at this point that is Uh and I've gotten thousands of emails to this effect They're willing to stand by and permit these injuries to continue In the name of preserving consumer freedom All the while pointing the finger at blame at what they call irresponsible caretakers In good conscience, I cannot do this First in most cases, I see little if any carelessness Instead I see reasonable people acting in perfectly predictable and human ways That sometimes lead to ghastly tragedies Moreover, even in those instances in which a caregiver may have erred Let's remember that it's the child who suffers and it's our job to protect the child And let us further remember that congress went out of its way when it wrote the consumer product safety act to provide us With the statutory authority to act even in cases of misuse So I have reluctantly Concluded that this is a product and in its present form requires a safety standard to protect the public And I want to mention one final point. I want to return to the issue Of the appropriateness of the commission voting on a safety standard for magnets while simultaneously Seeking the recall of this product from the market As I mentioned during the staff briefing on magnets, there is nothing improper about this at all A safety standard seeks to protect consumers in the future While a recall action seeks to remove a dangerous product from the market today Normally when we write a safety standard we permit the sale and distribution of products in inventory But in instances where a product presents a particularly serious hazard We seek the protection of a recall to safeguard the public Without passing judgment on whether magnets present such a hazard because I've not seen the case before me I note that if they do the commission is acting in a commendable And appropriate manner one contemplated by congress and blessed by the courts On a related point I find myself baffled to read a suggestion that the commission should have addressed the magnet set rule First before seeking the recall of magnets currently in the marketplace So I'm going to address this proposition generally not in the specific context of magnets And here's what baffles me the notion that the commission should leave dangerous products currently in the market While it takes action against products that haven't yet been distributed or perhaps not even made In the market seems topsy turvy to me I would liken it to finding your house on fire and making plans to purchase smoke detectors next week Rather than trying to put out the fire now And returning to my main point I repeat what I said at the staff briefing each type of proceeding carries different factual elements and different standards of proof But each provides all parties with the entire set of due process rights to which they are entitled In short, we're doing exactly what congress wanted us to do when it wrote the consumer product safety act over 40 years ago And I want to join in expressing my appreciation to the representatives of the medical community Particularly the pediatric gastroenterologist. I see we have a representative Representatives here. We can't thank you enough for your very substantive and thoughtful and meaningful input So again, thank you so much And of course, I want to acknowledge the presence of anica chaffin's family In the audience today amber I can't express how much I admire the courage that you particularly have shown in coming to this meeting today and sitting through that And I want you to know that We understand this has devastated your family as it would any of ours and we completely understand that this is so To state the obvious our hearts go out to you Please accept our deepest gratitude for you and your family making the journey to come today And finally, I do want to thank the staff for all the hard work that you've put into this package This is written under section seven nine and nine of the consumer product safety act which presents particularly complex Encumber some procedures for the agency to follow But you the staff have persisted and persevered You got it done and you got it right. So thank you all so much Commissioner Robinson Thank you, mr. Chair I would also like to start by thanking the staff for this incredible work that you did on this package In approaching my decision in this matter. I very much looked carefully at the statutes under which we operate in Rulemaking and specifically obviously at section seven and nine of the consumer product safety act Under those sections the requirements of such a standard Shall be reasonably necessary to prevent or reduce an unreasonable risk of injury Associated with such a product be in the public interest The benefits expected from the rule must bear reasonable relationship in its costs And it must impose the least burdensome requirement which prevents or adequately reduces the risk of injury I'd just like to quickly address each of those points and why I decided to vote in favor of this rule In assessing the unreasonable risk of injury I think that the data sets that we had left no question that there's was and there was an unreasonable risk of injury The first data was the nice data And in listening to the testimony from our staff with respect to how they came up with the estimate of 2,900 ingestions of the small high powered magnet I was magnets. I was struck with the fact that at even as large as this number is It is probably very low What we what our epidemiological staff did was looked at first of all the narratives Of medical treatment. So the narratives by definition are done for medical treatment And not to help us in doing our jobs and assessing the cause And in looking at those narratives, they were the the specific words that were necessary to get included in the estimate Were a known manufacturer of these small magnetic balls and or the words high powered magnetic ball Magnetic marble bb size magnet or magnet bead and those were necessary to be put in the yes possible category What we know is that in the incidents that were that were examined there was an estimated 7700 Incidents of magnets being swallowed that did not have those magic words. So we're not included So if anything this understated the incidents in this country The second area we looked at at the non statistical data that we have and we know that between january 1 of 2009 and june 24th of 2014 we know specifically that there were 100 incidents that involved the magnet sets at issue in this rulemaking And now we know of the tragic death of annie chaffin The doctor's data that they brought to us was also compelling and as dr. Brian rudolf testified This data that we have does not give justice to the issue. So I've anything I think that with the data that was that we had even though it made a compelling case for this being an unreasonable risk of injury It was understated. So the risk was even higher in terms of The public interest. I think that That I knew on on the commission, but I believe that This is a very very rare situation when the medical community so so uniformly gets behind a rulemaking And is so actively involved in trying to make sure that we take this danger off the market And that was very compelling to me in deciding that it was in the in the public interest The cost benefit analysis again Even though we ended up with an estimate of 28 million Annually in costs for these injuries versus 6 million in loss producer's surplus Obviously that in and of itself Ways in favor of passing this rule But again when we look at the caught the the algorithm that our staff used Um In in order to come up with the estimate of costs again I think that this was this was if anything an Understatement because what our staff used in the algorithm was the swallowing of any foreign objects And so we ended up with a situation where we had the the kinds of objects that most of time pass right through a body Being used as part of the cost estimates and not the kinds of horrific injuries that we get with these Small high powered magnets dr. Ian Liebowitz from naspegan told us in october that more than a hundred thousand foreign body Ingestions occur each year mostly in children and only 10 to 20 percent of the non high powered magnet Ingestions of coins nails pins, whatever require endoscopic removal And less than one percent will need surgical intervention However, 80 percent of the high powered magnet ingestions need intervention and 20 percent need significant surgery Dr. Marsha chaosl from naps began explained in Detail the kind of horrific life altering injuries that are suffered when Bowel had significant bowel has to be removed not only in terms Of the lifestyle of the child and the parents having to make sure the child gets appropriate nutrition but in terms of the of the Enormous medical costs that will be incurred as a result of the injuries and it's in their aftermath So when you consider the real costs of these types of injuries occurring with these products again I think we are the cost benefit analysis is very clear And again, and and I will not repeat what Chairman k and commissioner adler said with respect to what we tried to do through the commission To make these safer but in terms of looking at the least burdensome requirements We tried everything and as a doctor said they they had trouble educating their fellow medical professionals with respect to this danger Let alone educating the public generally So I think that this definitely is the least burdensome of the requirements So I believe we've clearly met all of the statutory requirements for this rule And I would like to in addition to having already thanked the staff. I really again want to Thank the medical community for how actively they have been involved in this rulemaking and helping us do our jobs And particularly with respect to the pediatric gastroenterologists, and I can't thank annie's family enough I know when a tragedy like this happens that the most important thing is to make sure That the death is not in vain and it was very important to us that you came to us And we took this very much into consideration. So thank you Missionary moharovic Thank you, mr. Chairman I guess I first have to begin with an apology for having Neither the poise nor the composure To adequately express my regrets publicly to annie's family here today I'm proud to support today's rulemaking Without the requirements set forth in this rule small and powerful magnets would continue to present What I consider the quintessential latent hazard to young children While I'm confident that this rule will achieve its intended purpose I remain troubled about the prevalence of other small powerful magnets That may persist in the home environment Be it from jewelry defective or recalled products therefore I anticipate And urge the agency to not view this rulemaking as the final step in mitigating this hazard But rather one element of an overall risk management strategy Furthermore, I hope that the harrowing recent history with this product category compels The agency and the entire safety community To reevaluate our collective competencies and capabilities to quickly identify And respond to emerging hazards In this regard the agency should accept the reality of limited resources internally And pursue every viable option To leverage our external stakeholders data for effective and timely market surveillance. Thank you, mr. Chairman Thank you commissioners. Thank you staff Thank you for everybody in attendance and watching and in particular Thank you again to amber and the chafe and family for attending today. I hope that Today's actions can provide at least some small comfort In this very difficult time for you This concludes this public meeting of the u.s. Consumer product safety commission