 Welcome back to part two of this public meeting of the United States Consumer Product Safety Commission. CPSC staff will brief the commission on proposed amendments to our fireworks regulation. The CPSC staff members briefing us are Dr. Rodney Valor, chemist in the Office of Hazard Identification and Reduction, Dr. Aaron Orland, chemist and also division director in the Office of Hazard Identification and Reduction. This is Meredith Kelch, turning the Office of the General Counsel and Mr. Howard Tarnoff, senior counsel in the Office of Compliance and Field Operations. At the conclusion of the briefing, we'll turn to questions from the commissioners. We'll now start with the staff briefing. Who's going to start? Mr. Valor, please. Thank you, Mr. Chairman. Today, Meredith and myself are happy to talk to you about the proposed amendments to fireworks regulations. I'll start off by giving a background on fireworks and then I'm going to turn it over to Meredith for a while and then I'll discuss injury and death data and then I'm going to discuss relevant voluntary standards when it comes to fireworks and as well as staff recommendations to revisions to the CFR and then I'm going to talk about the effect of adding aluminum to energetic materials. Then we'll go into an economic analysis and then we will conclude. So in 1973 and 1934, the CPSC took over fireworks regulations from the FDA and it wasn't until 2006 that ANPR was issued to conduct a fireworks rule review or look into changing the fireworks regulations and it was under the 2014 OPPAN plan that direct us towards a fireworks rule review and that was completed in December of 2015 and from those findings we were directed to prepare an NPR briefing package. So now I will turn it over to Meredith. So I'm going to walk through the statutory requirements that apply to this rulemaking just to give everyone a framework within which to view the recommended changes. So there are two statutes that I'm going to walk through the first is the Administrative Procedure Act and the second is the Federal Hazardous Substances Act. Rule makings in general are subject to the Administrative Procedure Act or APA. The APA generally requires an agency to provide notice and comment, notice meaning provide interested parties with notice of what a requirement would be in advance of actually creating a final rule and comment being the opportunity for interested parties to comment on the substance of those proposed requirements. The APA also provides for judicial review of rulemaking so that when an agency adopts a requirement, for example, a court is to set aside any requirement that is quote arbitrary or capricious as the standard for judicial review in the APA provides. In other words, a requirement that's not based on or tied to supporting data or facts. Turning to the Federal Hazardous Substances Act, this is the statute under which CPSC has authority to regulate fireworks. The FHSA allows CPSC to classify a hazardous substance as a banned hazardous substance and provides additional rulemaking requirements in addition to those provided in the APA. So the draft NPR includes three categories of requirements and they're laid out in this slide specifically, clarifications to existing requirements, easing of existing requirements and new hazardous substance bans which constitute bans under the FHSA as it defines that. The first two categories, the clarifications and easing of requirements do not create hazardous substance bans so they need only comply with the APA requirements. The last category however, not only has to meet the APA requirements but also additional rulemaking requirements under the FHSA. So under the FHSA, the commission can create hazardous substance bans, can create specific requirements and can create labeling requirements. Looking at hazardous substance bans specifically, there's one general finding that's required as a precursor. The text of that requirement is in the slide but to summarize it, notwithstanding labeling required under the FHSA, the degree or nature of the hazard as such that the protection of the public health and safety can be adequately served only by keeping the substance out of interstate commerce. This is the first of four requirements necessary under the FHSA. In addition to creating hazardous substance bans as part of that authority, CPSC can also create performance or design requirements for products that are hazardous substances. And finally the FHSA also provides for labeling requirements but our draft NPR doesn't include any labeling requirements so I won't walk through those at this point. In addition to the first finding, I just walked through regarding the degree and nature of the hazard. There are three additional findings that the FHSA requires for the commission to adopt a hazardous substance ban or a performance or design requirement. The next three slides will summarize these additional findings. I'll also give examples of the types of information that staff considered in assessing these findings. And in addition, the draft NPR solicits comments so that we can garner further information that would be helpful in assessing those findings. So the first of these additional findings relates to voluntary standards. It deals with the adequacy and effectiveness of an existing voluntary standard to address the hazard that the regulation seeks to address. When there is a voluntary standard, CPSC must find one of two alternatives in order to proceed with the regulation. The first of the alternatives deals with the effectiveness of the voluntary standard at adequately reducing the risk of injury and the second deals with the likelihood and extent to which regulated entities will comply with the voluntary standard. There are three voluntary standards that Rodney will cover in his presentation, making this finding relevant. In evaluating whether a proposed requirement has adequate support to make this finding, staff considered factors such as the percentage of compliance with the voluntary standard, the severity of potential injuries, injury rates and the vulnerability of the population at risk. The second finding considers the relationship between the costs and benefits associated with the regulation. The commission must consider whether the benefits of a regulation bear a reasonable relationship to its costs. Benefits may include things like reductions in severity and likelihood of injuries and costs include things like increases to manufacturing costs, sales prices and decreases to availability or usefulness of a product. And the third finding looks at the relative burdens and effectiveness of alternatives to the regulation. Finally, in addition to the substantive findings, the FHSA also requires that an NPR include specific content. First, the text of the proposed rule has to be in the NPR, including the latter three findings we just discussed. Secondly, any alternatives the commission may adopt and this NPR includes some alternatives. And finally, a preliminary regulatory analysis discussing the costs and benefits of the regulation, whether monetary or otherwise, the impacted parties, reasonable alternatives, the costs and benefits of those alternatives and why the commission is not proposing them. I'll now turn it back over to Robbie. Thank you, Meredith. To start with, I'm gonna discuss some of the injury data that staff has gathered during a special study period from June 19th, July 19th, 2015. And those are bookends for right around where most fireworks accidents occur. And this first slide that I'm gonna discuss has 31 in-depth phone investigations done by staff. And as you can see here, almost all of the injuries occurred due to either misuse or malfunction. Continuing on with this 2015 special study, these are the estimated injuries based on age group and type of device. All estimated in the rounded to the nearest hundred, you can see that most of the injuries occur in the age group between 25 and 44 and some of the more notable devices that cause the injuries are firecrackers, sparklers and reloadables aerial tubes that I will discuss a little further here because loadable aerial tubes have been the cause of the more catastrophic injuries, which brings me to the reported fireworks related deaths in 2015. In 2015, there were 11 non-occupational fireworks related deaths reported to the CPSC, seven of which occurred from holding a two mortar device and proximity to the body. I believe it was five. It involved a consumer holding a device on top of their head and igniting the shell and it took off and then concussive action created severe enough injuries to cause death. And then there was of those proximity to the body, there was also two where it was being held against the person's chest and it came back and induced cardiac arrest. There were two more deaths where it was from overlooking a launch tube. So it can be assumed that the consumer believed that the device was a dud, failed to function, went back to check on it, looked over the tube and unfortunately then that's when the shell took off and essentially decapitated the victim. There were also two more injuries caused from the manufacture of illegal fireworks so basically they were making homemade explosives which is under ATF jurisdiction. When looking at revisions, we staff looked at three voluntary standards, the first of which was American Pyrotechnics Association, AP 87.1 and that has been changed most recently in 2001. And DOT regulates transportation of fireworks and requires compliance with this standard. This membership to the American Pyrotechnics Association includes nearly 85% of industry and it has requirements for both consumer and commercial fireworks. We also looked at the American Fireworks Standards Laboratory voluntary standards or AFSL. They are always ongoing with updating their standard so staff has been attending regular meetings and it's always a point to look at ways to change the standard in the best interest of the consumer for safety and it incorporates both CPSC and DOT regulations. It represents an estimated 85 to 90% of all US fireworks importers and their testing shows 95% of the tested samples are compliant with their standard. Staff also considered the European standard. This is used by many countries worldwide and it's based loosely on 87.1 but the European standard considers many more devices that aren't here in the United States. So summary of all of our recommended revisions. So this is where staff came to the conclusion that on many cases we should be harmonizing with AP 87.1. And the first section 1500.3 is a definition section that are currently missing in our regulation but occur in the other voluntary standards. There are common terms used in the industry so we believe those should be included. 1500.1783 is probably the most contentious of the revisions. This is pretty much known as the Audible Effects Section and CPSC has been asked by industry on several occasions to look into modifying this part of the regulation. So I will get into this in more detail later but staff believes that we should adopt a quantifiable method for identifying devices intended to produce an audible effect. And going to defining that as having the presence of metallic fuel and less than 100 mesh, okay? And without, throughout the Reg we recommend that the Audible Effects portion be removed with the burst charge requirement that if metal fuel is present, metal fuel less than 100 mesh is present then the device is limited to two grains or 130 milligrams. And 1500.17814 currently we do not have any limits on things that are not intended to produce an audible effect. So in theory right now devices are limitless in their pyrotechnic composition weights. So staff believes in harmonizing with AP 87.1 once again and setting limits on the pyrotechnic composition in certain devices. Once again we recommend that we add definitions to relevant terms used by industry. And in the prohibited chemicals section staff recommends adding lead and lead compounds which are currently in AP 87.1 and as well as the addition of hexachlorobenzene which is HCB, which is found in the AF-SELVON voluntary standard. They also, we also recommend setting contamination limits of 0.25% for all the chemicals contained within the prohibited chemicals section as AP 87.1 also has and this is a good idea as well because as a scientist, zero is a very hard number to prove and as instrumentation gets more sensitive then it's gonna become more costly for industry as that comes closer and closer to like a single atom. The only exception for the 0.25 for the prohibited chemicals would be the HCB which would be set at 0.01% which is consistent with the AF-SELVON standard. 1500s, 1507.3 addresses fuses and currently in the consumers fireworks testing manual we already test for side ignition so we still care about accidental ignition and we just wanna clarify this and put this into the CFR. So currently our test method is tested out, we test out, we put a cigarette onto the side of a fuse tested out till five seconds even though three seconds is what we enforce. 1507.4, we recommend which is consistent with AP 87.1 defining what a base is as well as requiring that bases remain attached during normal usage and operation. This would hopefully discourage consumers from holding devices that they shouldn't be and preventing things like tip over which cause many injuries as well. 1507.6, staff recommends adding the APA definitions of burnout and blowout. These are terms commonly used in industry, burnout is essentially when a fireworks device just explodes on the ground, blowout was when basically a flame shoots out the side of it or the other way around, I'm sorry. And the 1507.13, staff recommends prohibiting devices from projecting fragments so we don't want like an aerial device to go off and it be raining shards of glass or rocks or hard pieces of plastic. So, staff recommends adding that requirement as well. So, back to the audible effect regulations. So, on this slide, this is the current CPSC regulation compared to AP 87.1 and currently, staff, when we are looking for devices intended to produce an audible effect, there is, it's a two-part test where it is the audible effects portion where you're, a trained staff member goes out in the field and listens for an audible effect. When the staff member does this, they are not listening for the, how loud the device is, but rather they're listening for a distinct noise made which is, relates to the presence of metallic fuels. If it is a black powder device, it's more of a muffled noise, whereas if it's a, if there's the presence of metallic fuel, it'll be more of a sharp, crisp sound. And that takes years to train staff to listen for such a distinct sound. And then, after that, that is the amount test. So, after it's been determined that it has had an audible effect in the field, then staff takes a device back and weighs it and the device should have under two grains or 130 milligrams of pyrotechnic material. Staff recommends harmonizing with AP 87-1, which would clearly just make this a laboratory-only test and reduce some of the, or make it more objective. And with this, it would be just looking for the presence of metallic fuel using an instrumentation like XRF or ICP analysis. And if metallic fuel was found, then it would be limited to the 130 milligrams. Also, current CPSC regulations, like I mentioned previously, don't have any limit for the amount of powder in devices if they did not produce an audible effect. So, staff recommends putting limits on the total pyrotechnic material for all fireworks devices. Okay, so, why is metal, why are metal fuels a concern? And that's why I have this slide up. Okay, so, this slide is a graph taken from literature and this is aluminum added to trinitrotoluene, or TNT. So, TNT is the standard for which all explosives are compared, so that's why they use this, but you can imagine things like black powder behaving very similarly, okay? So, first of all, the addition of metallic fuels increase the sensitivity of the device, so it'd be more sensitive to heat, shock, friction. And you can see on this graph, so this is explosive power versus aluminum content, percent aluminum. And so, staff believes that with greater explosive power, there's a greater injury potential. So, more power equals more ow, if you will. So, at zero percent, you can see on the far side, there is a known explosive power value. And then, as you move along, you could see ideal for having the most boom would be between 15 and, right around between 15 and 20% is for the optimal explosive power that you can get out of an energetic material. As you increase past 20%, the metallic fuel becomes ineffective. It starts to quench the reaction, so you have more fuel than oxidizer at that point. Now, staff recommends that there be no metallic fuel, but as I mentioned previously, we understand that zero is a hard number to prove, so staff recommends a compliance enforcement discretion of 1%, which is way far on the left side. At 1%, you only get roughly a 2% increase in the explosive power, but as you increase that by percentage by percentage, so at 2%, you're going to have 4% increase in energy. At 3.5%, you're gonna get roughly 7% increase in the increases. At 1%, also it can be considered still at that amount, a trace amount, staff believes, and at that point, it can still be a contaminant. Anything more than 1%, staff believes that to start to be an ingredient into the mixture, okay? So staff, in the long term, staff expects no significant burden expected with the Provojo's changes. Staff expects fireworks suppliers to comply with the new audible effects rule by substituting cheaper black powder for metallic or hybrid fuels, hybrid fuels meaning mixtures with metallic fuels added to black powder. So in conclusion, staff recommending changes harmonized with provisions of voluntary standards, AP 87.1 and AF cell, most of which are already required by DOT regulations. CPSC testing of fireworks samples revealed that greater than 85% did not comply with the limit of pyrotechnical material when any metallic fuel less than 100 mesh was present. Most of staff's recommendations are clarifications of existing requirements, and staff recommends publishing the NPR for comments on the proposed revisions, and staff also recommends a 30-day effective date seeking comments on that as well. And just at this time, I just wanted to thank the team members involved, I think Meredith, Robbie, Squib, from Econ, Jason Young from Compliance, Eric Hooker from Health Sciences, Toxicology, Matt Romer and Priscilla Burdino from LSC, and Youngling Two from Epidemiology, and as well as management for their support and guidance throughout this process. So at this time, and I'm sorry if I forgot anybody, I'm opening up for questions. Thank you, Mr. Valior, and I'm gonna pick up where you left off, thanking the rest of the team as well, including management, AKA Dr. Orlin. And also I see back there Mr. Stadnick, who is our lab director. I know that the staff has put in really years into trying to find a way to evolve our standard. And this, it was captured earlier in your presentation, this was triggered in large by Commissioner Robinson's amendment, I think it was maybe to the 2014 operating plan, asking for a full-blown rule review and from that, of course, we have this package and we're very grateful for that. We are very eager, I'm sure, to explore different parts of the package. The area that I wanna start with is really, which I think is the core of why we're here. Recognizing that these are explosives, fireworks are inherently dangerous products. What are the safety benefits for consumers that you or really anyone else from the team sees should the commission move forward and make these changes? Thank you, Chairman. The biggest piece of it is as Rodney mentioned in his discussion, right now there are types of fireworks devices where there's no limit in the CFR on how much pyrotechnic material is allowed. And so by establishing limits, then we're hoping that we can eliminate some of the more dangerous devices and keep them a little bit under control. And also by eliminating the metallic fuels that are very prevalent from our testing, we can lower the explosive power of some of the fireworks, still keeping them effective and fun, but eliminating the amount of explosive power so that if they're accidentally or haven't forbid intentionally used in close proximity to a person, then maybe we can limit the severity of the injuries and make them a little bit easier for the emergency rooms to deal with. And Dr. Orlin, thank you for that. So focusing on that part and at any point if I'm mischaracterizing where staff is, please let me know, but I think I picked up from the briefing that in essence, we are taking this from one of the voluntary standards that we would be, the staff is proposing that the commission adopt the relevant provision from the voluntary standard, is that accurate? Yes. And that also, if I heard correctly, that voluntary standard is presumably very much complied with according to representations that we're talking about high levels of compliance, supposedly with that standard, is that correct? It depends on which portions of the standard you're talking about. There are portions of both the APA standard and the AFSL standards that are very well complied with. AFSL has a independent testing program and so they have a method of validating that their product is complying with the standard. Whereas the American Pyrotechnic Association and the Department of Transportation do not have an independent testing program or capability, all of those are self-certified that they comply. So of course the manufacturers say if they wanna get their EX number for transportation, they say our product complies, our testing shows a little bit differently. Depending on the product type, the biggest hitter is these reloadable aerial tubes and some of the mind-shell devices, whether multi-tube aerial devices, most of those don't comply with that metallic fuel component of the standard. And are these made by manufacturers that are stating that they do comply or these are the carts that you see on July 2nd by the side of the road? Any of them that are shipped within the United States and interstate commerce have to comply with the DOT regulations and in order for them to get their permit, they have to self-certify that they comply with the regulations. So it's all of the above. Okay, so if I understand correctly, we would only be proposing that industry comply with something that they at least are saying, that their own voluntary standard requires them to comply with and they're saying they comply with now. So from a market disruption standpoint, this should not in theory cause a lot of market disruption. Correct. In theory? In theory. Okay. As there, you did an excellent job, Mr. Valor of explaining how you came up with the 1% that threshold. Do we have any sense and it's fine if the answer is no, I'd just be curious to know where we go from there as to how to translate that explosive power into risk of injury. Do we have any data on that or any theories about that? Well, I might have to talk to one of my toxicology and academia or I mean health sciences people, but the issue with that is there is no such thing as a safe explosion. So any explosion in proximity to human body is not good. Now we're just trying to reduce that by lowering that explosive power. Do we have any sense that 1% is very different than 2% or 3% from the work that you've done? But no. I see the chart. From the chart and from the fit, so as you go up, each percentage you go up, it doubles, so doubles explosive power. So 1%, 2%, and 2%, 4, and then like three, three and a half, it becomes more exponential. It becomes like eight or nine percent and that's we believe is a significant amount of energy. Got it. And the last thing I wanna ask at this point is, and we just covered this, that we are in essence mirroring the current APA standard in large part 87.1. Is that currently under revision and if so what might that mean? So the APA 87.1 is currently undergoing revision. They're actually taking, they're totally revamping the document. They're taking it from a single document that covers consumer fireworks, commercial fireworks and articles pyrotechnic and putting it into three different standards of basically A, B, and C. We have been involved with APA in reviewing and writing comments on that document. It's currently, I believe on hold, I don't know what the exact status is, but I think they're waiting for us to do something from our interaction with them and from what we've seen on the drafts. It's, there's not anything that's a real game changer that's gonna, if we come out with what we proposed in the NPR, we're not gonna contradict them or vice versa. Most of what they've done with changing the standard around or at least on the drafts we've seen so far have been more administrative in changing the way it's laid out and formatting and then separating out the three different, very different types of fireworks into their own individual pieces in hopes that that helps make it easier on the permit process with the Department of Transportation. And they've also been involved with Pipeline Hazardous Material Safety Agency, PHMSA over at DOT and reviewing that as well. So the exact status of it right now is kind of unknown. And I think that we're, both us and them are sitting around waiting to see what the other guy does and we'll stand off. So hopefully we can move things forward and provide a little bit better clarity. Great, and that helps alleviate my concerns that we might be moving in one direction and they might move in a different direction, but it sounds like that's not a concern, that's valid. Thank you very much, Commissioner Robinson. I just really, really want to thank the entire team individually and together for the excellent work that you've done on this. This is really highly technical and complicated or as we called it in my office, wonky. And it was, it's very much appreciated how much effort went into this. And as Chairman Kay mentioned, when I got, shortly after I got back from China with John Rogers sitting back there from AFSL and one of the things that I did there is visit where they make, it's hard to call them factories, but where they make fireworks. And I know a lot of our staff has visited them as well. When you combine that with what I've seen out at our laboratory in terms of the kinds of dangers that we're trying to protect consumers from, it's a really, really challenging problem. And I knew that our, we all knew that our standards were out of date and it was really, really important that we get this right. So, shortly after I got back, we introduced the amendment to the fiscal year 2015 operating plan asking for a thorough review of the fireworks regulations regarding whether the CPSC should maintain, revise, clarify or update the regulations related to fireworks. And then at the end of 2015, a year later, you presented us with an outstanding comprehensive package that I really appreciate with your recommendations on how we could improve our regulations. And then obviously in our, in our 2016 fiscal year operating plan, we asked you to come up with this briefing package. And I also would just like to thank Commissioner Morcherovic and I worked together very closely. We've both been very focused on fireworks for some time and we came up with in the interim a proposed interpretive rule for fireworks. I think based on my discussions with him before we proposed this interpretive rule to our fellow commissioners that we weren't expecting the large volume of comments that we got in, but my understanding is, and I hope it's correct, that those comments were helpful in terms of you coming up with this package that's before us today. So I also thank you for looking at those voluminous comments. So my question, I just wanna follow up on what Chairman Kay was talking about with respect to the APA. The first thing is that I remember being out at the lab with when some things were being examined that had the DOT self-certification. And I understand we've got some problems with this, which in terms of when we test the things that are self-certified that a lot of them aren't compliant. So do I understand correctly that it's even, this makes it even more important that we come up with something that's really enforceable on behalf of the CPSC? Yes, absolutely. Okay, and I also am talking to Dr. Borlaz in our weekly meetings. And I just wanna make sure I'm clear on this because I think all of us are concerned with what APA is doing in terms of their revamping, their standard. And Dr. Orland, you said that you, I don't remember your exact verb there, but you thought that they were on hold and were waiting for us. And I understand from Dr. Borlaz that indeed they're on hold waiting for us. Is that your understanding of where we are on that? Yes, it is. Okay, good. That was the last discussion we had with them was that they were waiting, waiting for us. And DOT is waiting until after the political climate settles out. When's that gonna be in my life? Next Friday, yeah. Okay, so we should go ahead, as I understand it, without concern that they're gonna do something while we're in our process. That's correct. Since we know that the political climate won't settle down. The other concern that I have is that this is a very, this is an unusual package in a lot of respects. But one of the things that makes it really unusual is that there's almost five pages of items that we are requesting comments on. And indeed, I was reminded of the RFIs that we most recently did on crib bumpers in terms of listing a lot of areas that we need more information on. And in the reg flex analysis, you noted that a number of the recommended requirements that would create new hazardous substances ban that there's not sufficient information to make a finding to support a final rule on a number of items, specifically adding two chemicals to list of prohibited chemicals, adopting a test method to evaluate side ignition and prohibiting devices from projecting fragments when functioning. My first question on this is for these items, do you anticipate that you're gonna get enough information in response to this NPR that we're going to be able to formulate a final rule? Or do the analysis we need to do to formulate a final rule? We're looking back at Econ, I know. I know. Thank you for your question, Commissioner Robinson. For the regulatory flexibility analysis, as far as findings go, it's only necessary for us to produce findings in the event we're recommending that the commission certify the rule will not have substantial impact on a significant number of firms. And so we don't, in the initial regulatory flexibility analysis, make such a recommendation. And so dependent on the comments we receive, if we receive sufficient comments to make such a recommendation, then we would do so. If we do not, we'll proceed with a final regulatory flexibility analysis in the same vein in which we did the initial regulatory flexibility analysis. Thank you, that's very helpful. And the other concern I have, given how much information we've asked for, is have you guys as a team sort of come up with a plan of what resources are gonna be required for the next step, because I just wanna make sure you have enough because I think this rule is very important. So yeah, I mean, probably a little bit more complex to provide exact details on, you know, how we're planning on shoring up some of the technical details of what we wanna do, because we're still ongoing with collecting data and looking at things. There's a lot of areas where we wish we knew more information and there's a hope that maybe somebody in industry will provide us with some of the data that we need. If not, then we'll go out and collect ourselves, but it's probably a little bit out of scope of the timetable we have here to talk in detail, but we can provide that as a follow-up. Just please let us know what resources are needed and I will do everything I can to make sure you have them. And thanks again so much. Commissioner Berkel. Thank you, Mr. Chairman, and thank you to all of the staff today for the presentation. As my colleague said, this is a highly technical case and I'm relying on your expertise. I do wanna compliment my colleagues, Commissioner Robinson and Mohorovic, for all the work they have done and the attention they've paid to the fireworks issue. And we have heard from many in the outside community regarding in the one problem that you mentioned is this audible effect issue. So I look forward to learning more about the package and getting some of my questions answered now, but I'm sure we'll have additional questions as we go forward. So one of the things I wanted to talk about is the data. On page seven, no, I'm sorry, on page six, the fireworks injury data and the hazard patterns. So that's not traditional nice data because it was just a very short period of time from June to July. So how do we go about gathering that data? And yeah, we probably need someone from Epi. It's in depth investigation from the NICE data. So each year we conduct special study around the July 4th because average each year, like two thirds or three quarters, the injuries, fireworks related injuries occurred around that time period. So we conduct special study during that time period. We pick up the most severe injuries like hospital admissions and eye injuries, finger, hand and mutations. And then the hand injuries, we assign those cases to telephone interviews. And then those 31 cases are the ones completed for 2015 special study period. Okay, so you're reviewing the NICE data on a daily basis as it comes in. And then you follow up with, if it's a fireworks related injury, you follow up with phone calls to the hospital. Okay, it wasn't clear about how that all works. And then with regards to that same diagram, what are the other injuries? It says there's four in number of cases, but 13% of the injuries. It says at the bottom, other and then debris. Not this slide. It slides, it's page six. Those four cases from the incident scenarios, we cannot pinpoint the problem. It's the victim just said they felt something flow into their eyes. So we cannot say this as misuse or mis malfunction. So we say it's like other categories. All right, thank you very much. And then on page seven, and again, and this may be an upbeat question, just I'm saying seven, but when I look up at the screen, that number is different, but it also has to do with the fireworks related deaths in 2015. Again, is the sole source of this our nice data or do we have any other sources of this? We talk about the- No, these are from the news articles. And then from the field reports. So this is from like the clips that we subscribe to. When you say news articles, and what was the second source? The news articles and then sometime, I think most of them from news articles. Okay. Thank you. On the next page, it talks about voluntary standards and it says APA membership includes nearly 85% of the industry. And then it says AFSL represents a message that made it 85 to 90% of the importers. Can you just clarify that for me? So the AFSL is that they're numbers saying 85 to 90% that's of the people importing stuff from mostly China. And because China is where most of the fireworks originate, they publish their membership based upon the percentage of the people who are importing from other countries. Whereas the APA, they report their membership based on fireworks retailers and sales and the entire industry as a whole. So both of the two organizations represent overwhelming majority of the fireworks industry in the United States. Good, thank you. But AFSL also represent some of the importers where they're located in China sending stuff here as opposed to companies in the United States that are pooling fireworks from China. Thank you. Thank you very much. How did staff decide what the pyrotechnic limit should be for the fireworks that are not intended to produce the audible effect? We looked at APA 87.1 and those values are mentioned there. Okay, so that just mirrors that standard. Yeah. Okay, all right. And has the staff revisited whether the two grains of pyrotechnic composition is the right amount or is that? That's another one where it becomes a question of what's the safe level for an explosion and close proximity to the human body and it becomes a very difficult question to answer. For me, that number is zero. On firecrackers, which result in a large number of hand injuries, the limit on those currently is 50 milligrams and we recognize that they create a lot of damage to the fingers if you hold them in your hand instead of letting them go in time. So two grain limit applies to things that are not typically gonna be held in your hands and those are gonna be used further away from the body. So we say that that's a long historical one, but it's one that's really difficult to answer is whether or not that's good, bad, or anything else. It's kind of a difficult question to answer. Okay. That's all I have for now. Thank you, Mr. Chair. Thank you all very much. Mr. Marrovic. Thank you, Mr. Chairman. I wanna compliment all the staff who contributed to this effort and especially our Executive Director. Thank you for also making staff available to me on several occasions given all of the work that you have in front of you. Thank you for spending that time with me to help me better understand what is an incredibly thoughtful, comprehensive proposal. It's obviously the recommendations. It's obvious to me the recommendations that you make are sound and in the public interest. I also want to demonstrate my appreciation for my colleague, Commissioner Robinson, for her leadership in this area and also to compliment the dedication, the time that she has spent personally to get a better understanding of this industry far beyond my understanding from going and seeing the way these products are manufactured and sharing those learnings with me and with the rest of the commission. So thank you for your dedication on a smart product category to spend time on. Fireworks, as the Chairman mentioned, is one of, if not the most dangerous products we regulate. So I think all of this work and the time spent on it is perfectly appropriate. I do have some questions for staff, if you'll indulge me. The first set of questions I have relate to the proposed changes in 1500.1783, to the Audible effects test. Could you, and I appreciate all the work in the corresponding memorandum, which is available to the public too, which demonstrates transparently some of the preliminary testing that's been done to prepare this package. Could you provide, because I do think it's important for the public to understand a general explanation of the Audible effects test as it stands today in terms of some of the preliminary testing that you've done, as well as some of the results of your work with regards to potential compliance rates, what you've seen with the proposed suggestion in adopting the APA language. Don't make me pick one of you to answer. Okay, so currently, as I mentioned in briefing, the test that we currently conduct is a two-part test. Okay, so that is, there's a field portion where a staff member listens for a distinct sound, and if it, as this sharp report that I mentioned, then it is taken back, so that is the field portion, and then once, if it's determined that it did have an Audible effect, if we do hear that sharp crisp noise, then it is taken back to the lab, cut open, and mass is made of pyrotechnic material, and if it's at 130 milligram, if it's less than 130 milligrams, it would pass. If it's greater, then it would fail. What was the, excuse me? Well, what I'm really just generally looking for in terms of what the expectations are, so I understand the change is really going to clarify or change the method with which intended to produce an Audible effect will be determined, moving from a technical staff expertise determination to the presence of metallics. If you could just generally relate for the commission and for the audience paying attention, what would we expect to see in terms of the amount of product that would be rendered under the new proposal as intended to produce the Audible effect, and then therefore subject to the two grain limit, which you didn't mention, but of course it's stated clearly the two grain limit will stay the same. It's really just getting at what product is intended to produce that Audible effect, other changes aside. So the crux of the difference, our current test is we go out into the field and we listen, and then if it's determined that it's intended to resolve that, we come back to the laboratory, we sieve out the less than 100 mesh portion of it, weigh that, and if it's over 130 milligrams, then the device is violative or potentially violative depending on how compliance decides, and then if it's less than 130 milligrams, it's just fine. From the technical piece of the proposed test, what the laboratory would do is we wouldn't rely on listening, which the fireworks industry has complained about for years that it's kind of a subjective test and they have difficulty repeating it. So the change would be that we would use the presence or absence of metallic fuel, which is currently banned by the voluntary standards. We would adopt a very similar provision to what's already, the industry already accepts as intended to produce Audible effect, which is the presence of metallic fuels. If the metallic fuels are present, we would sieve it, weigh it out, and if it's over 130 milligrams, we still recommend compliance that it's violative, and if not, then it's okay. Understood, thank you. Maybe from a compliance point of view, I don't think I'm doing a good job of answering my question. So Mr. Tarnoff, if you could stay with me. And from some of the preliminary testing, not statistically valid samples, but just from the preliminary work that we've done, from a compliance point of view, in terms of our expectations and the impact that this may have on the market, do we think that there will be fewer or less product rendered intended to produce an Audible effect and therefore subject to the two grain limit under the proposed revision, or as it currently stands with the field testing? I think it's hard to predict. I think some of the products we currently find violative may not be violative, and other products that we pass may not be passed. So we don't know. What we've done as a preliminary look at it, and I think I've run these last slide to show that there are currently a high percent that have some presence of a metallic fuel, but I think we've found that most of those are under 1%, in fact, most are under 0.4%. So we think the majority of products would comply, which is what they should do since they have a voluntary standard, which has been adopted by DOT as a mandatory standard. So we're not really asking for anything other than what is the current standard in the industry, and we would be allowing for the enforcement discretion up to 1%. Excellent, thank you very much. It's a slightly different subject, but still staying with 1500, 1783. With regard to some of the tables that were referenced in the lab sciences memo, specifically I think it was table six was provided showing some demonstration of some preliminary testing, and the results as they were determined by using XRF instrumentation versus ICP. Was the purpose of providing that one to ensure that XRF technology would be applicable and fit for use as proposed under the new proposed changes? Yes, table six, basically what we did was correlated our XRF data with our ICP data, and if the XRF is under the right conditions, if you use it correctly, it would be a very viable screening process, and we think you could use XRF as opposed to a more expensive technique at ICP. It would be a very effective screening analysis. Excellent, thank you very much. I think I have time for just one more question, and this brings up tables seven and eight with which Ms. Kelsch brought to my attention, and I think it's important to relate. It has to do with some of the findings there, and maybe Ms. Kelsch or one of the other panelists might elaborate on the significance of that data, because if we do propose to move to the APA approach for determining inaudible effect, and if in fact we move to a 1% contamination limit, then that would require a significant amount of quality control and quality assurance with regards to potential contamination of aluminum or magnesium, and that had always troubled me somewhat, Commissioner Robinson, based on, and I haven't seen, I have not visited a fireworks factory, but I think I know with confidence that they're largely handmade, hand-constructed products, and with that method of manufacturing, that introduces the potential for great variability and variation, so I was really troubled with whether or not, if we move to a 1% contamination level, whether or not that's even possible under the current dynamic of how these products are produced. I mean, can somebody making a handmade fireworks limit to 1% or less a contamination limit, but maybe you can describe what you've found in table seven and eight and how you have confidence that you believe the industry can get there reasonably. So I shared your concerns. In 15 seconds. I shared your concerns about whether or not the industry could do this as well. We've heard some concern from the industry that this was possible, so we went in and we looked at, one of the allegations was that the visual effects, which also have aluminum powder in them a lot of times, were contaminating the brake charges, and we wanted to go in to either prove that that was the case or disprove that that was the case, and we looked at it, it was very difficult because most of the, as we said, most of the brake charges that we looked at had aluminum presence, so it was very difficult to find ones that the aluminum wasn't intentionally added. As a short-term fill in the gap, we looked at the other metallics that are in the visual effects, so strontium makes nice red colors, barium makes nice green colors, and copper makes nice blue colors. Is that right? Dyslexia makes me mix those up sometimes. We looked at the effects that should not be in the brake charges, because there's no reason for them to be there, their expenses, there's no reason they would add them, and we looked at them, and what we see is that when there's a couple of percent of strontium or copper or barium in the effects, we see very small amounts, less than a percent, usually around the quarter to a half a percent of these metals contaminating the brake charges, and we have confidence that with aluminum, when it's not intentionally added to the brake charge, it's also not gonna contaminate the brake charges from the effects as well. Excellent, thank you, I thought that was a point, well worth making, I apologize for going over, thank you. Commissioner Robinson? Nothing further. Commissioner Berkel? Nothing further. Mr. Mohorovic, back to you. I do, I apologize, just on two other subjects, and first it gets to 1507.3, is that the proposed, where the proposed change to the side ignition test resides? The side ignition test, it occurred to me that that doesn't reside in our regulation, but it resides in our test manual, so we have the, so then is the test manual considered a de facto? I guess I'm going to try to use everything, but the word backdoor rulemaking. How we got a side ignition fuse test into a test manual, do we consider that a substantial, well that question can't be answered. Interested in, well let me ask this, when did that get inserted, if you know, into the test manual, the side ignition cigarette fuse test? It's been there for a very long time, the current regulation, and correct me if I'm wrong Meredith, but I believe it says something to the effect of the fireworks must resist side fuse ignition, it doesn't describe how, it just says they must resist. I see. And so the interpretation of that in the test manual has been three seconds, which is the industry standard. Right. It's been in our test manual since the current revision which is 2005, 2004. Okay. I forget off the top of my head, but it's been there for, you know, a decade or so. It's not, I don't think it's what you call backdoor rule, we have to have a test method for determining what is resist side fuse ignition, so it's, that's what's currently there, and that's what the industry standard is, is a cigarette held on the side of the fuse for three seconds or longer. Right. But side fuse ignition resistance does not reside in our regulations, is that correct? The regulation does provide the general provision that it has to resist side ignition. It does not spell out how to assess whether it resists side ignition. I appreciate it. So that's what lays in the test manual. Yeah, that's perfectly appropriate. Thank you. I didn't know that until this very moment, so thank you. I do have some other questions. The last ones, commissioners and panelists to bear with, it has to do with 1507.2, the recommended changes to add some elements to the prohibited chemicals. For those that are not familiar with hexachlorobenzene, can you provide a little bit more information in terms of the potential risks associated with it and why staff is recommending it be added to the prohibited chemicals list? Hexachlorobenzene is a particularly toxic chemical. It's banned from global production in almost every country, including China. But it has traditionally been used in fireworks because the addition of chlorine helps makes the colors brighter and flashier. It makes the visual effects more appealing. What is the nature of its toxicity? How is it? In what way is it toxic? I think we must have somebody from health sciences that might be able to contribute to a better understanding of the nature of its toxicity. Sorry, I have to refer to my own memo here. Well, several agencies have determined that it's a carcinogen and has developmental toxicity, reproductive toxicity, toxicity to the liver, padicellular carcinoma, so more cancer. And I notice also that staff is recommending adding lead, and we're all very familiar with lead in its toxicity. Could, does staff have an opinion in terms of what might be intermittent exposure to lead from fireworks and whether the fireworks pose that hazard? Is there, can you explain maybe the exposure scenario that we're concerned about, which is why we would consider adding or prohibiting lead from being in the fireworks? Well, we have no information about exposure with fireworks to any compounds, but we just, we can hypothetically imagine it's dispersed in the air, settles on the ground, and it can be inhalable, it can settle on surfaces for hand-to-mouth contact, yes. Exposure, understood, thank you. Now, was this proposed regulation, I know that what Commissioner Robinson had done to, to jump-start it again, did this begin with an ANPR? Not exactly, there was an ANPR issued in 2006, which explored a couple of issues, one of the most broad being, are there things we should add to our regulations? But it wasn't a regulatory review and it didn't go through specific areas in the way that this package does. So to some extent you could say that this is a follow-up on the ANPR, but not really some of the issues addressed in the ANPR have since been resolved, such as certifications. Okay, so, and then that matter was not resolved or withdrawn, so it remained on our agenda, our rule-making agenda, the fireworks ANPR? I don't know that it stayed on the agenda, it's... It did. It did. Oh, okay. It's on the regulatory agenda, if that's what you're asking. It is, and it has been prior to the rule review. Yes. Action of the Commission. Correct. Great, so we did have an ANPR, and I recognize that the ANPR at that time in 2006 was somewhat wide open, but I do recognize in section 31 of the Consumer Product Safety Act that the Commission may not issue an ANPR for regulations under section 2Q1 of the Federal Hazardous Substances Act relating to a risk of cancer, birth defects, or gene mutations from a consumer product, unless a chronic hazard advisory panel established under section 28 has in accordance with paragraph two, et cetera, submitted a report to the Commission with respect to whether a substance contained in such product is a carcinogen, mutagen or teratogen? Hope I pronounced that correctly, teratogen. So, with the CPSC recommending adding HCB and lead as a prohibited chemical because of its concern as a carcinogen, we would be doing so without having had assembled a panel, a CHAP. And does that create any problem or are there any designs to put a CHAP together so that I know the statute requires that we do that in advance of the ANPR, but we already had, that's why I was getting to procedurally where we are. You know, do we have an ANPR on the books already? So we do, so we're kind of picking that up from, do you see nasty things happen when we release these things out there for decades and decades? So we have an ANPR already out there which perhaps I would imagine in 2006 didn't really envision the carcinogenetic effect or hazard. So therefore the CHAP wasn't put together. Anybody thought about CHAP as it relates to section 31 of CPSA as it relates to FHSA rulemaking? We can certainly look into that further. My initial reaction would be that this section 31 that you're referencing falls within CPSA and our rulemaking would fall under the FHSA. But that's certainly something we can examine in more detail for you. I would say the commission may not issue a rulemaking, section 31, B1C and an ANPR rulemaking for regulations under section 2Q1 of the FHSA. And this is FHSA rulemaking. Excuse me, Commissioner Moorovic, I think we're venturing into some legal analysis that we should provide to you in another arena. Okay. Is it the chairman of the commission's desire to, according to our DNPs, go into executive session or do we want to put this matter off? And I think it was clear that we haven't done a full legal analysis yet, so I don't want to be off the cuff and I think we need to follow up with you. Okay. Thank you. That's all I had. Commissioner Robinson, anything else? Commissioner Berkle, anything else? Commissioner Moorovic, anything else? Alrighty. Having heard no further questions, this concludes the second part of this public meeting. Thank you again to the staff for all this work. We look forward to follow up discussions on it. Thank you for those who have attended or are watching online. This concludes this meeting.