All right, it's 201. So I'm gonna go ahead and get started. Hello, welcome. Thank you for joining. My name is Cassidy West. And I'm the Policy and rules manager at LCV. I've been taking the lead on this project since the legislation went into effect last year in July 2023.
And so I do want to just start all of this out by saying that the rule development this entire process has been a very collaborative effort with LCB staff, hemp licensees associations and industry groups, consumers, tribes, the public health prevention community, as well as the cannabinoid science workgroup and the general public. So I just wanted to thank you all for all of your time and input throughout this process. Okay, so since the legislation was effective, and 2023, and just to back up to see where how we came to be where we are today, we've had various stakeholder engagement sessions, we held a virtual collaborative rulemaking workshop in October 2023, and discussed some of the major policy concepts like how to measure and report THC, that now you're going to kind of be saying the almost final iteration of what that looks like today, we distributed a follow up survey in January to provide interested parties who were unable to attend the October engagement. Excuse me, and or they had thoughts afterwards, to be able to have an opportunity to participate in the rulemaking. We've also received many written comments, and I've had a lot of great conversations with partners. So today, is the last day and a series of workshops that we've been holding over the past several weeks. So thank you all, if you've been able to attend, we're going to go over all the roll sections today which have, it's the culmination of the feedback from all of those previous stakeholder engagements I just mentioned, in addition to what we've received during these past few weeks while we've held the workshops, not only in the workshops, but we've got some great feedback afterwards in between. And so we do still have an opportunity to for feedback. After today. We are accepting written comments on this, this exact set of rules that's online until May 15, at midnight, so 11:59pm Actually, and you can send any roles, sorry, comments to rules, feedback, questions, anything. If you want to follow up to our rules and boxa rules@lcp.va.gov. We have posted the website agenda and the draft rules that we're talking about today, on our lcbs Laws and Rules page. It's also under the current Outreach page. If you don't have access to them, or haven't had the opportunity to find them or access them, you can go ahead and put your email into the chat. And then Tierney will go send you an email with a workshop materials for today. I'll just give you a second if you want to do that and Okay. All right. So today's workshop is actually an hour and a half. The agenda does say two to four, we are only going to so we're going to go through the changes have an ample opportunity for everyone to discuss and provide feedback on the changes. So we will stop and I'll wrap up with some next steps right at between 325 and 330. We'll take a 10 minute break if if people want to stay afterwards, if they have questions if they logged on late. And I want to go over some of the changes again. We are available and until four so I do want to clarify that we if you do have to hop off at 330 That's totally fine. We will be finished at that point with the session. All right. Any questions before we kind of start diving in? Okay. And tyranny and LCB? Folks, please let me know if there's hands because I sometimes miss them. I can't see everything right now with the screen. Alright. So the goal of today's workshop is to review and discuss the draft language for modifications that are being made to the whack chapter 314 pitch by these changes are necessary to align the current roles with the statutory changes that resulted from engro second substitute Senate Bill 5367 known as the TFC bill. So the rules weren't just guessing today are not final. And the feedback we received today and through May 15, and will be considered as we finalize the draft proposed rules for the CR 102. Filing, we plan to file the CR one or two on June 18. And if the board approves the CR one or two, they're the rules are no longer draft proposed rules, but officially become the proposed rules. And so once that CR one or two is filed, we will have another opportunity for feedback. The formal public comment period begins and we will have a public hearing on on the proposed rules. And so just process wise, if there are not any substantive changes that are needed to be made to the rules after the during the public hearing. And between that formal comment period process, then we're going to we can move forward with the rules as they're proposed and have those adopted if the board approves the CR 103 filing based on our timeline here, it would be that the rules would become effective on September 14. All right. So I'll go ahead and just a couple of ground rules, housekeeping items. We want to make sure that we're respecting other people's views, no personal attacks, or disrespectful comments, one speaker at a time. So you will not be able to mute and unmute yourself, please raise your hand and you will be taken off mute. The chat feature is available for you to ask questions, or provide comments. However, any of the comments or questions in the chat will be addressed at the end of the presentation. So I'll go ahead and walk through the rules and then then we'll have the discussion. But so if you do have a comment or question, please raise your hand and then we'll unmute you. We encourage you to come off camera. Please state your name and affiliation. Please keep your comments concise. So there are a lot of people, there's a lot of stuff to go over. So each speaker has about two minutes to provide comments on each discussion prompt. But like I said, we do have time between that 330 and four o'clock if if we need more for. For other people. We just want to make sure that between this hour and a half, we get everyone's feedback. That's here, it has to be back.
Hey, Cassidy, there is a scheduling question in chat.
Yes. Could somebody read it aloud? Let's see. Okay. Okay, yeah, um, the June 18 is a Tuesday. We don't have the board meeting on June 19. And so we'll be having the board meeting on the 18th. So other, we're actually having other filings that day, so everything will be held that day. Thank you for that question. Okay,
so just going back here to the ground rules. So please provide constructive and relevant feedback. We welcome all feedback. However, we can only make changes that are aligned with the rulemaking scope, and within the legal authority. So please focus on the information that we can act on. Please also be specific. If you identify distinct parts that you think should be changed, or parts that you support, we encourage you to suggest specific wording changes. If you think we miss something in the analysis, or certain sections, explain what additional information or concepts that you'd like to include. If you could provide concrete examples of your concern, any hypothetical or real, that would be great. If you have a concern or challenge that can better be addressed in a different way. We welcome all creative solutions. And any suggestions you have on how we can solve our problems, issues, implement this legislation in a way that can strengthen what we're trying to do here. It's great and very important to us if you can explain why, why the issue or topic or suggestion matters to you and how it affects you. And then as you're aware, a study or article directly related to the topic we're trying to address is very, very welcomed. We strive to incorporate the best available science and information in our decisions. So any questions before I dive in a little bit more? Alright, so today, I won't go into really a background on the rules, just what we're doing. So 3367 As you all know, Nick's made it lcbs authority to regulate the products containing any detectable amount of THC. And also amended the definition to include all forms of tetrahydrocannabinol, which is not just delta nine, THC and THC A. And so else LCB has been tasked with establishing what any detectable amount of THC means, and addressing impacts and areas and rules related to how THC concentration or content is measured, reported and labeled. We also are incorporating the new definitions of packaging unit that were created by the legislation. There were some amendments to the packaging and labeling statutes as well related to that incorporating package into that language. And then there were some changes to the cannabinoid additives sections also in statute that we are incorporating here. So here we go. As I go through the the draft changes, I'm going to reference the relevant statutory changes being implemented. When we do have questions and time at the end, please let us know if you you don't if you would like more clarification on why or how we came up with a specific recommendation or proposal right now. And again, these are all draft. So yeah, I'm gonna go ahead and share the roles here on the screen. Because there's just so much to go over. I'm not going to read a word, like word for word, all the rules. Language, sorry, like, get this nice and full screen. So I won't go through, but I will give a summary of what the changes were. And give everyone an opportunity to read it. If you do not, if you're on your phone or don't fit in, can't read it or calling in. And you would like me to read something, please let me know, just something in the chat. And somebody will ping me to let me know. Okay, so we're just gonna go over what changed.
So these are technical changes, nothing substantive happened here in terms of rules. So and you know what, let me zoom in so everyone could see better. So, this, these are changes to the definitions sections that were made based on based on the statutory changes or statutory changes to the definitions. So the legislation amended the definition of cannabis, cannabis products, and THC concentration. And so those defined terms are added to this section. And instead of reiterating the full definition and statute, we reference the statute, statutory reference. So that is what when we say cannabis as the meaning provided in our CW 69 5101. That's what we mean by that. And so if you see any of the terms that we've added, new, which are in red and underlined, that have this language, those are just referencing already existing, statutorily defined terms, we're just adding these to make sure that people know that there are specific definitions for when these are used. We also, as you may notice, some of the definitions that weren't amended so for example, cannabis concentrate here. These were added just to provide they were very relevant to the amended definitions and some of the changes that were made. So these already defined statutory terms were added that include cannabis concentrates, we have cannabis infused products, just scroll down because there's not really a lot to read. Oh, allergies, I don't think my full screens freaking out. I'm okay. Maybe this will. Sorry about that.
Okay, sorry, I'm gonna go back to where I was. Where are the definitions? Okay, so, um, there's no substance here. Like I was saying, these are already defined terms. I'm gonna just scroll down, like I was saying the more defined terms that are existing. And then I'm gonna keep scrolling and so we're gonna get to this new term. that has no one's seen before. Here. Since our last engagement, we got some feedback. And so we put this definition proposed draft definition together to describe the what a conversion factor was for when you're calculating the total THC. So what the decarboxylation rate is for different cannabinoid compounds. Now that the definition of THC concentration has expanded to include those in addition to Delta nine. As you all know, this isn't a new concept. So in the current rules, where it references that, you know, 0.877 number, that's it comes from that the formula to calculate the total THC and CBD. And this is just simply a way to describe that, because when we get to the testing section, you'll see that we've replaced not replaced, but we're using the term conversion factor. Since different THC compounds have different molar masses. After I go, actually, I'll just stop there. And let me give you a second to read that.
If someone let me know. I'm gonna move on and about 30 seconds, but please let me know if you need more time. Amber, I will take your question in just a second. We're gonna get just get through all of these changes. And then we'll come back to it. So please make sure you note it or feel free to put it in the in the chat. Oh, thanks, Greg. Sorry, I won't get distracted. There was something else in the chat about the schedule. But But thanks, Sandra, yeah, just feel free. We're gonna get to that in a second, just so we have time to go through everything. This is something though, that we want feedback on? Do we need to add this clarification at all? Do you have suggestions for how this language can be improved? Does it make sense or not? If not, what do you suggest? So I'll go ahead and move on. So you can start thinking about that a little bit. Then we just have decarboxylation, their removal or elimination of the carboxyl group from a molecule or organic compound. So this is also known just supplementing. To provide I guess supplementing the conversion rate definition. Again, if you have thoughts, or suggestions on how to improve this definition, if you have questions or if it's unclear, hold them until the end, or you have until May 15 as well to provide comments. Okay, I'm going to scroll down, if somebody please just put it in the chat. If I'm moving too fast, I'm just going to keep on going. At any point, don't hesitate to stop me. Okay, so I'm still in the definitions section. And now we are on page five. And so I have again, reference some definitions that are already existing. These, however, are not existing statutory definitions. These definitions are in WSU A's rules for lab standards. And I've referenced the section there. And so that's where those came from.
I won't spend too much time there. If you have questions, or we can certainly pop those into the chat. If you want to see the full definition or of anything, just please let us know if we can provide additional clarity and we'll try to start making sure we put that together for the end. All right, I'm gonna keep scrolling down. All right, we're again. So we're on page What page are we at and the definitions section. And so I've just added the bill created a new definition for package. So again, we've just referenced statute here, no, no change in terms of like an actual substantive rule change. However, there is a new definition of package that we're incorporating throughout the rules. So we'll get to that
All right. Going too fast with Adobe
you know, I get oh, here we go
all right. And then the other two definition or three, I believe definitions that have been included. And we'll get there in just a second are also already existing definitions. So these are not something that we've created in the rulemaking. We're just referencing other definitions. One of those is synthetic cannabinoid. That's already defined in our CW 69 5204. You can read the definition here. The legislation created a new section that specifically banned the sale of manufacture production of any synthetic cannabinoid, other than those approved by the FDA. And so this, we're providing clarity for what synthetic cannabinoid means. Again, this is a statutory definition. So just referencing nap.
Okay, and keep on scrolling. All right, so then we have this is a big one for today's conversation, as you all know, the definition of what tetrahydrocannabinol does. So what is THC? This is a defined term, and also that section are CW 69 5204. And then the last change to the definition section is the new statutory definition of unit. There was as you can see an existing debt roll definition of unit. So we've repealed that and just provided the statutory reference instead. All right, so I'm gonna keep going. Like, we'll get through just all the changes all the sections, all seven.
Okay, so now I'm in medical cannabis endorsements, wack 314 55 Oh, Aido. I don't want to spend too much time on this, because Daniel Jacobs, one of our rules, coordinators, recently filed a CR one or two and somebody please correct me if I'm, if I'm wrong on any of this on dates, but I know he recently filed filed a CR 102 I, I believe the rules will be effective, I'm not even gonna try to estimate please feel free to put it in the chat, Daniel, if you're here. And so that's the changes made here. Or are just the same changes that are already in that role that will become effective. So I'm gonna scroll down to subsection four, just so you can see those changes again. And just briefly, what's going on here is now that the definition of cannabis products includes any detectable amount of THC, that 0.3% or less threshold is no longer the differentiating factor for what a cannabis product is. And so we're striking out because anybody can sell cannabis products, not anybody if you have a retail license, and as long as it has a detectable level of THC, which now can be below below that 0.3% Based on what what we're proposing here. However, I do want to make sure that everyone knows medically compliant products can still be given away to patients so
Alright, so um, cannabis servings and transaction limits. We've moved on to whack 314 55 We have it nevermind. I won't go to Daniel will talk about the medical cannabis endorsement but Daniel did put a timeline on that in the chat. Okay, so for cannabis serving and transaction limitations. What we're doing here, changes were required in this section so that we could incorporate the new definitions of packaging unit. There was also the amended definition of cause a THC concentration plays a role in here we'll see in a second with Yeah. You know, this the serving size limitation and then also We've included language to we've built in language regarding the low THC bill, HB 1249. That was the past this, this past session, so 2024. So I'll just go and start scrolling through that. Alright, so first things first. So I've created we've created a, an attempt to clarify that active THC. And in total THC are the same thing. And it's this neutral form of it after it's been decarb t carboxylated. X after THC currently exist in the rules. And so it's in this section. And so this is just to clarify, since we do have a lot of terms floating around about what content of THC is, we have to use concentration, total THC, active THC. And so and and in an attempt not to change already existing usages of terms. There are some were these proposals are to clarify the way that they're already being used. So that when you do see those different terms through other rules is clear what is what. So we are very much seeking feedback. And let me zoom out on this definition as well. Whether or not I'm just apologize for this, but it's a funky page
oh my goodness, okay. I probably no one's gonna be able to see this after I zoom out completely. So if you're on page 18, that's where we are. But I'll just go ahead and read it out loud because it is so disjointed for purposes of the section active THC or refers to the post decarboxylated concentration, but the tetrahydrocannabinol is detected in the product. The active THC must include any THC compound with a concentration of 1.0 milligrams per gram or milligrams per milliliters as appropriate. So that brings us to our next point, the threshold that we have going on here for what active THC means. So because the legislation has expanded the definition of THC concentration to include compounds other than only delta nine THC and THC A what our goal here is now that we have a serving size of 10 milligrams of active THC. So what what what's included in the active THC. That is where this threshold what the threshold of the one milligrams per gram is intending to address. I will say that we dug into looking at other COAs quite a bit of COAs just to see which THC compounds other than delta nine the naturally occurring levels and different types of products. So we looked at flour, we looked at concentrates and even within those concentrates the different levels that are occurring for like wax and shatter and distillate and just you know based on the concentration method and what those cannabinoid profiles look like. And so thc v has been the only THC compound that we've seen in any amount above above the detectable limit, which is actually lower than this. And so, and the thc v concentrations that we're seeing are right about at this 1.0 milligram per gram level. However, that's in distillate we're not seeing that and edibles. Of course, like I said, we appreciate if we've if we've missed something in the analysis, where you have additional research that you could provide related to this, regarding whether or not this particular threshold needs to be higher or lower or measured differently. Please let us know. Okay. So with that a single serving can still only contain 10 milligrams of active THC. And I just I'll provide a quick example here. I think everybody's up to date with what this means but what this would be saying is if you have a 10 milligram threshold of APA single serving is 10 milligrams of active THC, then if you happen to have a milligram of Delta eight, for example, then you only can have nine milligrams of Delta nine. This is what the this is the legislation that's being implemented, whether or not all of the th C's should be included in that active THC limit that is above a certain limit is certainly something that we are interested in hearing from you all on. And again, just looking at the practicability of this, there aren't other real THC compounds that are actually meeting these levels. So we're hoping not to, or we're not trying to make additional requirements or impact the industry in any way that would require people to really, really change their processes. And if that is the case, then please reach out. And again, this is just for edibles. Okay, so then I'm just gonna keep going. So we have time for discussion. Okay, so a single unit of cannabis concentrate cannot exceed one gram that actually existed, I just moved it down in it, it moved it in red. So to clarify. We have also just with regards to the package and unit situation, replace the term unit with package and made that made the language align with the statutory definitions and be consistent with that. I'm, again, trying to change as little as possible. Um, and then the the big new thing here is just adding this language about the HP skews. Somebody helped me out the low THC beverage bill, I don't I can't remember the number right now. And so a single package of liquid cannabis infused product can contain up to 200 milligrams of the active THC, if it if each unit is individually packaged and contains only four milligrams of THC. So we're not creating that policy. We're just putting that in rule. So it's clear instead of just putting it in roll, since it is a new statutory requirement. I'm scrolling down here to the transaction limits. Again, we've just if you scroll down to sub sub, okay, so we're in transaction limits, subsection D, and then sub subsection D. And we've just added the language regarding the low THC beverages to the cannabis infused liquid form transaction limits. All right. So the language again here, that's being repeated, if you're watching the screen, is just the same language repeated above regarding what what active THC is, and while the threshold would be for that. All right, I'm gonna keep scrolling. Again, same same language with the just trying to do as little as possible to incorporate that. And align the roles with a definition of packaging unit. We're still using servings. So please let us know if you have questions about that if we moved on, when we get to the end, sorry.
All right, I'm gonna keep on going. Okay, so this is the big section here. quality control and quality assurance testing. You will see references throughout where we've changed language that might seem like a lot. But we are actually just making a few adjustments based on House Bill 2151. And that is related to the trend, transitioning the lab standards over to ws da from less. And so for example, it it looks like a lot here but it just instead of saying to become a certified to become a certified lab, we have cannabis licensees most use a certified lab to conduct quality. Oh my goodness, this happens every time. I have a 1249 Thank you Mark. Can somebody give me a thumbs up if my dogs are as loud to you as they aren't me Okay, I'm sorry. It'll be done in just a second
I don't think all right, okay, I'm gonna keep going. We're good firetrucks. Okay, so um, this is not an exhaustive. So there are other changes that do need to be made to the quality control and quality assurance and other testing standards. Per House Bill 1249. Thank you, Mark for that. I misspoke. Oh, good. I say 1249 is low. Yeah. Okay, that's what I that I'm sorry, let me let me clarify if I did misspeak. 2151 is the transfer the lab accreditation, and 1249 is the low THC beverages. So those are just the new legislation that were implementing here. And kind of with the lab accreditation, I hope that's not confusing, but we're going to actually be opening a separate rulemaking for that and tackling this a little bit in more detail. So with that, I'm going to keep on going. Okay, so, you will now see references to potency analysis replaced with cannabinoid concentration analysis. And this is just this is not a change to what type of test it is. But it is simply a language change that was made and WSD as rules as they took over those lab standards. And so we've just changed the language here to make sure that we're consistent with that. So when we say cannabinoid concentration analysis, we need potency test. I'm gonna keep on scrolling. So I've been sent a subsection two of the testing standards, and this is nothing new here. But just that licensees have to provide a record that acknowledges the transferred in receipt of the samples to maintain the chain of custody, again, just kind of revised reworking the language that we currently have, since we're not, we don't have the authority over overlap standards, but require the licensees used to lab zoom, we would like it to work, like you would like to work, or to get, like get to work. Okay, I'm gonna keep on going. Because that's not necessarily aligned. All right. So when we go back to potency analysis, I'm in subsection three a quality control, analysis and screening. So again, we've just replaced potency analysis with cannabinoid concentration analysis. It looks like a lot of word changes here, and I'll give you a second to read it. But what's going on, at least in this first section, and then we'll move on from there. I've moved already existing language up regarding accurately measuring and reporting, the lab results into the traceability systems, and that they have to be reported. Also, we have a current limit of quantitation and roll that is 0.1 milligrams per gram. And and thank you for that. If I do. We'll take comments, questions and any sort of suggestions if we have missed something, like I said at the end, but thank you. So licensees can only use certified have labs that have an established limit of quantitation of what the rule currently sets. So my point is here, we're not getting we're not changing anything with what testing equipment is needed. For for what that limit of detection is. There is a table currently and rule. Let me I'm just gonna scroll down. Go ahead. So yeah, the lower limit of quantity quantitation is 1.0 milligrams per gram currently for CBD and THC. And so just scrolling up here, that is what this is intended to say. It's just in word form. And then we've also here Yeah, and then we've also added the should be 03. Apologies. Do we just added the rd corresponding limit of detection for our already existing limit of quantitation? This is for all cannabinoids tested. As it currently Yes. All right. You know what, I'll just leave that for a second. So that you all can read it and let me know if you have questions. Again. There's nothing nothing We're actually new here and rule in terms of policy changes with the language
Okay, I'm gonna move on. Alright, um,
Cassie, Cassie, there was a, what I think is a salient comment in chat there, I think they're mentioning LM, D and ello Q might need to be reversed.
Oh, um, you know what, we'll get back to that at the end, if there is, um, there may be some inconsistencies or something that was maybe miss mistyped as we were cleaning up all these roles.
Alright, so I'm just going to how to the CBD and THC concentration. So like I had mentioned previously, we have those THC content terms floating around total THC THC concentration, and active THC. And so this CBD and THC concentration is absolutely nothing new in terms of what's already being reported on your CoA. So you already measure your CBD, your CBDa Delta nine THC and delta 90 ca using at least the limit of quantitation and load of detection that already exists in current role. So the change here is just for providing a little bit more clarity on what this means. So this is the Predict decarboxylated form of of each concentration or, or how it appears on your COA at the time, not after you've calculated for the decarboxylation rate or whatever we want to call it. And so, as it currently stands, you still have to identify each cannabinoid or compound that you're testing for. Currently, it's only delta 90, and CBD. And so this is the big change here. Like I had mentioned before, the now the other other THC compounds other than delta nine are included in the definition for what THC concentration is. And there's already an existing definition in statute for what THC is, which is quite broad. We haven't included here, a non exhausted non exhaustive list of various THC compounds that would be included in the definition that already existed statute of tetrahydrocannabinol oils. So this list is we talked with labs, we've also talked with other states. And just looking at the quantitation capabilities and detection capabilities of of different cannabinoids out there, we included a list of what we know at least like I said, not exhaustive. But the list of things, a lot of you are already testing for it anyway. And so hopefully it shouldn't be anything new here. We understand that this definition is extremely broad. And there are likely practical and feasible, like practicality and feasibility concerns related to this change. And I'll when we get to the end, I'll certainly let Justin step in, because this is something we've talked about extensively. And you know what, before I moved down, I'm just gonna give everyone a second. You can look at the list, Delta eight, Delta nine, delta 10, THCV, th, C P, and I realized that a lot of these are not showing up in any of the products at least at any sort of level that would be at the detectable level that we're we're currently already testing at all right. Okay, so now we're going to the total THC and CBD. So once you have your concentrations, and it's the value you determine after the decarboxylation process, so you're already calculating these, you calculate your total CBD with your conversion rate of 0.877. Same thing with the THC. But now that the delta nine is not your only THC we the the although the formula hasn't been revised, we just made I made it a little more broad meaning that instead of just if, if you can see the screen here, and stead of it saying 0.877 It just says conversion factor to account for the different molecular weights of those different THC compounds, which I realized probably don't even need to be calculated right now because of the levels that are there showing up and
let me stop here to give you all a second to look at the total THC and CBD language should be nothing really new here. We did previously have that you have to report by driveway. However, we got some great comment that the role is currently you know, folks are testing it as it as is are as the samples currently received. So that's been changed to wait so. Alright, I'm gonna keep going so that we have plenty of time for questions. Um, yeah, like I was saying, so instead just go into the total THC we have conversion factor here. So that you could calculate it if you need to, for other compounds. If and when that happens. The this language that we've included about only certain about prohibited THC, so those that aren't naturally occurring in the plant, or those that are synthetic or synthetically derived, like THC o or J W H O 18, for example, that may only be present. So again, this isn't something that we're creating as a policy this is just clarifying what the legislation good. Alright, gonna move a little bit faster now going through the testing that was it, that just so we could get the packaging labeling, which is the next, the only real big change after this
And so the packaging and labeling that we're going to dive into in a second when it loads is, is intended to correspond with these total THC changes and, and what that looks like on a label. Um, and so again, we're going let me just scroll it down, I'm gonna get ahead of myself here.
Well, I hope everyone's having a good day while you're I watching this load, I will. Like I said, please feel free to drop questions in the chat. We are not expecting to get all the answers today on any of this stuff, because it's a lot thrown at you. We've been amending it. As we've been going through the workshops, there's been many iterations. So we're accepting comments until May 15. And there may be a better way for me to get to this
I guess there'll be a little slow today. It's okay. So I'll just dive into what we're about to get into, which is the legislation as you know, created those new definitions of packaging unit. And so also the packaging and labeling statutes were product late product, retail product labeling statutes were amended to incorporate that new definition of package. And what that means is it just simply replaced the term package with container. However the I'm so sorry that this is happening. Here we go. Nothing changed. So a package is still a container on the way that you're currently doing your packaging and everything. This doesn't impact that this is just a language change. Alright, we're here. Um, so the next thing we are going to get into that is that THC concentration and when it needs to be reported on the label. And so just going back to what we talked about with the testing with the total what the total THC and CBD so the threshold which is also up for something that we would love feedback on that we've incorporated of one milligram a gram or 0.1%. Um, we would use up sorry, I should show you language, it's gonna make a lot more sense. It's like, please. Okay, I'm finally at the packaging labeling. We're going to scroll down to if you have the rules in front of you and are able to scroll better than I can then if you Go to the language about reporting total THC and how that should look on a label. That's the that's the main thing that's changed here and what we're talking about in just a second. All right. And so what we're saying here is if you have a THC if you have an let's start with concentrates, if you have a THC compound that is not delta nine that shows up on your in your testing that exceeds the detectable limit of 0.03 then you would have to calculate the total THC for that specific compound in addition to the THC, total THC for Delta nine. So the total THC calculated separately for every THC compound that shows up on your analysis and is detected based on our detectable level which we are also seeking feedback on. And there we go. I do want to point out it says cannabinoid concentration and analysis results I don't want that to be confusing. If it's easier just potency test results should be reported. That's really what that's that's saying. Yeah, so for concentrates, you have to report each THC THC compound that's detected in the analysis, which again based on our research doesn't appear that anything except for thc v probably and distillate would appear. So hopefully this won't be too much for people of course, let us let us know. So move on to the same thing for flour. And then for the edibles that is something that we'll get to in just us and I will just say if you see references where I've struck out containers or packaging again, that's just a technical change to align with the new language new definition package
Okay, yeah, so just for edibles we just have the potency results expressed in milligrams per gram for the THC compounds that are detected in the analysis. This is like I was saying this draft language should we include a the threshold here like we have a milligram per gram or not, how should it be reported on here? So that's what we're asking today. And it may not be consistent with the testing as it is currently written. But that's something we definitely want to do and make sure that we're doing so we welcome any language suggestions that you have to make sure that we're doing that I'm sorry to keep going all right, um, yeah, yeah, so same thing here. I'm just gonna go to liquids because that's the only here's where the other language so yeah, sorry, same language here. And practice and like I was saying in real life, the only THC compounds that should be detected based on this would be the thc v so hopefully not not too much there. And I won't even get into it actually, but I'm pretty sure that if you do the total THC calculation with the two CVA and thc v that I've seen in just flour, any of it that it would still be below that one milligram per gram was so or even below the detectable level of THC. But we welcome additional data points if anybody has any. All right, alright. So the only other changes and I'll keep going we're out of the packaging and labeling section. Now like I said, flours written just like concentrates, expressing those as a percentage instead of by weight instead of milligrams per gram or per milliliter like ELB edibles.
Don't want to scroll too fast here. The other change we made coming up is to BOC 314 55 106 and That is just simply again, replacing, replacing container with package, no substantive change there. And then for the cannabinoid additives section, which is in 109. And apologies, I'm just, I'm talking faster than the mouse is scrolling. But um, and also, I'll stop here, we're at 106, just so you can see that it's just a little strike or not. Um, so I'll just keep talking. Whenever we get to the cannabinoid additive section and just a second, the only changes there are just 100% aligned with what statute did. So we're not making up the policy we're just replacing where previously a CBD product was defined as having a constant THC concentration of 0.3% or less, it's now any detectable amount of THC. And we have just reiterated that language, in statute and rule. And that is, that's it actually, for the changes. I will give everyone a second myself a second also. So I can scroll down here, and I'm gonna go back just so y'all could see that 106 package container. Nothing crazy here. I know, I'm talking fast. So slowly down, if someone if you need a second, we're almost done. All right. Um, like I was saying a second ago for the cannabinoid additives, we've replaced that, instead of, you know, having a instead of a CBD product having a concentration of 0.3% or less, it can't be a cannabis or cannabis product, which are now defined in statute. And that's been expanded to include any detectable amount of THC for those products. You'll also notice that we added that you can't, the CBD additive can't contain the presence of a synthetic cannabinoid, that actually already does exist later on down in this in this section. And so that's nothing new. This is just This is exactly how it's written in statute. So that's, that's all that's changed here. And then the final change to this section is we reference the testing rules instead of repeating the potency testing rules, so that if there are any changes in the future to those rules, we we can or if we want to differentiate what those testing rules are, and this one, I might just be a little bit easier for readability. Also, to make sure that any changes we make to one section, we don't miss anything consistent twice in another section. I do apologize for this screen. I hope everybody does have access. But I'm gonna stop for a second give you a minute. I'm gonna grab some water for y'all to start putting your emails in the chat and I'm sorry, not emails in the chat, comments or questions suggestions and then we'll go ahead if you want to raise your hand and take some take some discussion I'll be right back.
Okay, um, apologies for the the screen but let's go ahead. I don't know that I see any hands raised but we could certainly start going through the chat questions. Let me just want to finish this and show you where I've changed the testing thing. In this 109 section, okay, so here we go. I just reference 102 that the cannabinoids are the the potency test or cannabinoid concentration analysis has to be conducted in the same way that it's required under the waktu One forfeit if I wanted to. Again, instead of just repeating it, so nothing big here. Alright, so I'll just go ahead and start going through the chat and stop sharing my screen. Okay. And what we'll do as I am, I'm just I'm gonna take notes of all of these feedback, suggestions and everything. We have more time, like I said, If you don't, I don't expect anyone to have all the thoughts gathered today, given how, how many iterations of the rules we've had. Okay. Justin has flagged some comments. There are a lot of comments, and I want to make sure I don't we have 25 minutes. Right. Apologies. I'm just getting to make sure some of these have already been.
Amber, I think Justin, you took that feedback? I can not Oh, the rate or extent to which Thank you. Thank you, Amber. For that, that feedback on the definition of the conversion factor? There certainly isn't a formal one. So any suggestions that you have to improve that language? We will certainly take into consideration we really appreciate it. I'll just take hands, because since we do have a record in the chat here,
but Jessica, go ahead. I don't know if you can unmute yourself or not. Let me change my settings. It doesn't look like you can quite yet.
Oh, okay, we have another comment. Thank you. There.
Yes, okay, I'll input your right, it is very expensive and testing a compound that doesn't exist. There's a lot of questions there. What states require all the compounds to be tested, none of them. We are the first state that has such a broad definition of THC. Like we do. What labs or we discussed this previously, we have, I have actually a list of all of the stakeholders in literature review and research that we have everything that we did and our analysis throughout this process. And so I will provide that to you. Or work working on finishing it up, just want to make sure that we're incorporating everything from this feedback session. So between the time that the comments are due, so you'll have all of that how many molecules on the list of labs have to test for I'll let Justin weigh in on the the THC. The expansive list of THC molecules, now might be a good time, because it keeps coming up.
So when we were talking about this issue and doing the legal analysis, the way the statute was passed there, the THC concentration does include all of those. So we're needing to be able to record that for the consumer. So if it's not something obviously, if there's there's some components that have been called out if it's not something that can be tested for we we don't want it in included, of course, when we're looking at the recording of the different THC is the concentration is going to be identified separately. So we're not trying to do a cumulative THC concentration in the entire lot. But we do have advice that that indicates that all of these things should be tested for now, if they can't be. And it's not something that's common. We need a look at that. And so if that's something that you have feedback on, please let us know. Again, these are all works in progress. This is not anything final at this point in time. So some of the questions can also be formed in you know, a point of suggestion, if you will, if something doesn't look right to you, because we may not have the exact answer that you're looking for. So please make sure that you're looking at that
Thank you, Justin. We are the first state to do this like this. So please, we do appreciate any. This is a collaborative effort. So thank you. Amber, since you have your hand raised, I'll let you go ahead Oh, she can't unmute tyranny.
And while I'm waiting, I'll go ahead and answer your question, Jay, about the SP is when we'll do that for labs. So after we get the comments from the May after May 15, we're going to work on finalizing the draft rules, Draft Draft proposed rules. So at that point, based on that feedback that we've received, well determine what requirements language any of the things that we're talking about today, stay don't stay are changed. And at that point, we will do an SBI s and hopefully we're not going to need one. But yes, that is something that we'll have to do after we get feedback.
Just to clarify, so we're not committing to the small business economic impact statement. It'll be whatever the regulatory Fairness Act and, you know, requires of the rulemaking so as we get towards the finalized draft versions that will inform whether or not that's something that is required for the board to do of course, we will do that upon the assessment if it's required. Thank you.
Um, I'm gonna go did Amber, I don't know if he got clarification on
I did not get clarification on Question two. I mean, I realize this list is maybe under discussion, but whatever list you decide on will we need to add more compounds to our current list. I mean, this is I did the estimate last night mathematically on this cost of these standards, these are all super rare standards. Some of them to my knowledge don't even exist in the plant. And it would increase the cost of cannabinoids tests by 10 to 15 times what it currently costs.
Well, I would we would love just got analysis. That's amazing. If you could send that over. We really picked that
was one of my first questions to have you discussed this with because this is not this is like totally out of left field. So I you know, like any other cannabinoids that were like, on your list is not supported in the approved cannabinoid method that was recently updated by the WS ca. So you know, I think there should be some conversation between what methods they're accepting us labs to use, and what methods we are able to use to detect these molecules. Like my understanding is th CP THC, Pa come out at minimum 25 minutes retention time, and you need an LCMS to detect them. So we're talking about like a complete overhaul here. No.
And that's actually great. A great point. And I think I'm going to ease your concerns a little bit there. So the current rules of the statute, the way that it was written, any of the standards or changes to the concentration, measuring that we're doing here, it does, no one is required to have to buy or use equipment other than gas chromatography. So if the current equipment that you have, which is gas chromatography, and it is not able to detect some of these th C's, which, again, are required by law, because that definition already exists, and it's very broad and expansive. And there's, unfortunately not much we could do about that. However, like Justin was saying, like the practicality of it is obviously very important. So because you don't have to get gas chromatography, I wouldn't expect and somebody adjusted and correct me if I'm wrong, but I wouldn't expect because you can't test for for that right now, based on what we're requiring. That's not necessarily a cost that we need to worry about at this time, since it's an impossible kind of to test for some of these things right now.
So it would be helpful for folks that are working with the labs if you provide us information on the list that's that you see before you in these drafts, if there is something that would require additional equipment or something along those lines, please let us know. So we can you know, take into consideration those those variable as well as will cross reference with the statute states. So just if you can provide that feedback on the specifics, it would be really helpful for us to, to navigate through that issue. Yeah,
thank you for that. And along those lines, however, way that we proceed with any of these changes, any of them whatever they are, we are very interested in no implementation timelines. So if there are things that need to be the need, people need to have time to adjust to, we are very much open to hearing that feedback and how much time you'll need to be able to minimize that additional burden as as we transition to any potential changes that may occur in this rulemaking.
Okay, great. Oh, great. Okay, we have some feedback here. Okay. And I will say, Thank you, Amber, for the HPLC methods. So I, one of the limitations I maybe to my to looking at all the COAs that we did for those concentrations, or so seeing with the THCV showing up in higher concentrations than about the detectable level was HPLC testing. So I wasn't able to really find a lot of representative sample of CoA is that use gas chromatography? So I do want to just provide that data limitation there.
Yeah, I've noticed, no one uses gas chromatography. That's what I thought. But no, thank you for that. If anybody does, or you know, anybody, and you have sick CoA, so we can, it's really good if we can just like start, create as much data as we can have to understand what can be tested for what and what those levels look like, because I do understand the different testing methods impact the results. But anyway, so anything that you have to help us further understand this is greatly appreciate it. Okay, we have a question from Owen. To clarify my question, how much value can I add to a product to sell out of state before I run the risk of violating the law? Is it purely a commercial designation? So this has has to do with? Oh, and thanks for your question. We Yeah, I think, Amber, you may have answered it. Oh, no, sorry. Oh, and your question is related to Justin. So you pop on? I'll let you stop it.
I think his questions related to him based on his previous question. So when does industrial hemp become cannabidiol product, we are going to be looking at that on the unlicensed side of the equation based on the detectable limits. So if it's an end product that's going to a consumer and it has detectable limits, that's when we would be investigating that as a cannabis product being sold without a license. Other than that, we don't have any regulations, or laws around hemp, and out of state sales, it's not something we're addressing, you're not able to do any out of state sales within the I 502 system.
I do want to get to this gas chromatography thing, because there may have been some may have been confusing a little bit with that. Um, and so we are not requiring that anybody get gas chromatography, we do realize that people are using liquid chromatography and other methods. And that is totally fine. Gas chromatography is what the State Patrol uses. And before
it's, so what we're what we're trying to do is, is ensure that section six is applied across the board of 5367. It says nothing in this Act shall be construed to require any agency which we're going to extend to, you know, beyond that, to purchase a liquid chromatography mass spectrometry instrument. So that's what we wouldn't be trying to bring into play if it's not something that labs are using right now.
Yeah, and so yeah, to that point, because they can be a lot of the cannabinoids can be tested at a more at a lower threshold on that equipment as opposed to gas chromatography. That's like the whole the whole thing here. So we're not we're not, we're certainly not wanting to increase costs where we don't need to.
I'll just use wanted this we should be from Amber. Thank you, we should be aligning our current rules and standards with other states. I think that it is important as we move forward as an industry to be consistent because we are creating a policy kind of from the ground up instead of federal down. And we have a lot of opportunity to create that. However, I will say that, because of the way the legislation was written, we were the only state that's, that's implementing something like this. So as much as we would love to be consistent all of us I think, as regulators throughout the US and cannabis. There are limitations to what we can and cannot do based on statutory mandates. And some of some of what the other states are doing, which we did do a lot of research into most of what other states are doing are aligned or within the scope of what we can do based on what our statutory mandates are. So while I agree with you, we also are under a certain limitations that limit our creativity, or whatever you want to call it. I think we are actually the only state with the detectable limit, adjusted to answer your question. And that also, yeah, with a detectable limit. And with the broad definition of THC as well, a lot of the other states in their roles, they define this either THC is just referring to Delta nine, or they actually define the other types of THC. I've really only seen Delta eight and th CB that's in California. But yeah, I could be wrong, somebody please send us something if I'm wrong, but this is based on the latest information I have. We're kind of spearheading trailblazing this policy for the first first time.
Yes, so I want to go back to the ello. Q's. Thank you, Nick with confidence. Other states have ello Q's, and LOD is usually at one milligram a gram. That is what we have currently. And that is what is staying. So no change there. Apologies if there is a typo, or zero missed or something. I think someone may have pointed that out earlier. But I do want to clarify whatever the existing limit of quantitation is that you're currently using, as long as it is at one milligram a gram as currently is in rules as current and current rules, not the redline version we have if you scroll down a little bit, you'll see that table that didn't change that's just intended to be now words. And I've added the corresponding limit of detection. Again, if there are issues with zeros are I'm I've misrepresented a number. The intention there is not to change anything with what that limit of quantitation is currently. Yes, the limit of detection is 0.3 milligrams per gram. Which is somebody please correct me if I'm wrong, but also 0.03%. So yes. Apologies again, if I miss type that.
Alright, I'm going to keep going. So delta eight, or any other naturally occurring molecule molecules listed are allowed and the product is is it allowed to have adult have a delta eight THC product only? Yep. Yeah. If that was naturally occurring.
Yeah. And that that's the thing is, it occurs so low in the plant right now that we would be suspect of anything that is, you know, being identified as a Delta eight only because you cannot have synthetic or synthetically derived products. So if a plant is, you know, engineered, and I haven't heard of one yet, that's just delta eight, then theoretically, that could be possible. But at this point in time, we'd be scrutinizing, you know, any any product that doesn't, you know, isn't containing what we would identify as naturally occurring? And that's just based on information that's readily available publicly.
Right. Yeah. And yeah, and, like Justin was saying, we just always, if anybody has more CO A's or test results that they want to provide, I mean, this is so helpful, not just for this project, but other ones too, because it does help build our knowledge to make sure that the rules reflect that question about if we can access COAs from stores. So the current rules require that retail stores have CoA is available for customers if upon request I didn't go around to retail stores and ask everybody if they had a COA. I looked online we also have our data from CCRS and our Nazis various we have COAs from our enforcement division that were provided. And so So yes, and that's not where I got them I didn't go get them in stores physically that is
better if their stores that want to send them on over All right, so it's 322 next steps, so um, oh, Nick had a relevant question. Thank you, Amber for that. Apologies. I missed that. What are labs expected to do about a value between the LOD and the ello? Que I'm not 100% that I follow that could someone rephrase it for me please?
I'm sorry, I'm not. I'm not like a scientist. I'm not 100% What you mean, but I'm the value between the LOD and ello que okay, yes, I see what you're saying now. Um, okay. So if something is below 0.02% thc. And your limit of detection is 0.03% THC, then your COA would say not detected, for example, if it wasn't detected, based on all those things I just gave you, um, it and so. So that's it, it's not detected. If it's 0.29999999 not detected. When it hits three, though it is and I just probably made that way more. I'm not mad at medically right or AC but yeah, nd not detected means below the limit of detection. So if it's below 0.03%, which is what's being proposed are point three milligrams per gram. So there's no it doesn't. There's another really between the LOD and ello que like, nothing changes, this isn't, this isn't really impacting you all as an industry so much. Because what you're already testing for where those limits are fine. You don't need to worry about if your product is below that limit. Unless you unless whatever you're putting out there has such a low amount of THC, because it has other cannabinoids, for example, that you wouldn't Sorry, I just got distracted by the comment. Um I apologize for change because now so it is I want to clarify I don't it's not an accumulation of mol sorry, not accumulation and cumulative of molecules. I'm not really following these it could could Jessica Do you mind coming on mute? Just so I can make sure I'm following this properly I'm unmuting her I just need one second. Thanks
so here's so that I think the issue is is before total THC was essentially THC and THC. So there was this limited touch the limit of quantitation based upon two molecules. Now total THC is a substantial list of molecules. And so the question becomes your total THC is now the accumulation of that substantial list of molecules. So they're cumulative. So
it's not actually the it's not all of them together. So it would be if you tested each one of them individually. So delta nine still that limit of detection is how it is currently, we do Delta eight you use the same current limit of detection for Delta nine if if you test it you can test for it. Same thing with all the other molecules. So we're not adding them together for a total THC. We're just saying that if it if, if the compound occurs at a particular concentration that we're deciding, then at that point, you need to calculate it. So you would have total, whatever THC concentration and total delta nine and so on and so forth for however many that you had. And that would be again, calculated using that conversion factor, which were we were trying to be more broad to account for the difference in the molecular masses. Okay, I
think I'm confused because I thought that list of THCV delta A delta nine, all that was there was a cumulative threshold by which products could have a certain amount of the cumulative threshold of all those, is that not the case?
It's well, it's not the case. Yeah, because we're creating it. But it depends. There's so if you're talking about flour and concentrate, there's not like a cumulative amount. It's just if it shows up in a certain amount, we, it might be good to put it on the label, because it's something that consumers should know, potentially has has psychoactive potential, I guess. The limit comes into play when we're talking about edibles with that 10 milligram active THC limit. And so yeah, so that's what I think you're talking about. So yeah, um, if, like, if there is a THC that shows up above one milligram a gram, then that's part of the TC. Like I said, we did try to look in when we were establishing this limit to see what concentrations things are already testing out so that we were thinking about edibles, like would this really change anything right now? We may have missed something. But we were we're not necessarily thinking that based on this policy, edibles that are currently being produced as they are, are really having to change this, this change really is more towards just having to add an additional labeling requirement. If you're a if you have flower concentrates, because that's probably when only you're gonna get those other THC compounds anyway. If that made sense, I hope if not, I
think there's a little bit of the maybe backwards in the sense that like, generally, you're going to see these accumulate when somebody takes something down to distillate or something like that. So for example, if a flower has point 5%, deviate, if you concentrate that down, let's say three or four fold, you're going to end up with one or, you know, one and a half 2% of Da in it. And so I think that, you know, the question becomes, you know, this window between LOD and ello que, whether it's cumulative, kind of in the edible space, and what that looks like. But I think, Nick, you might have a very different question.
Thank you for that, um, I need to think about maybe how to clarify this a little bit more and follow up with a group, but I understand what you're asking. I'm just gonna so thank you for that. And of course, feel free to follow up afterwards, as well. Nick, going back to your question about creating an LOD definition, we're not creating a definition. i We don't even really have to put that language in there. And I think it might be actually causing more confusion than then this helping anything? Yeah.
if I can. So the way that the statute you know, is being implemented or was written not being implemented, it's already in place. There is that level of detection. So anything with a detectable amount of THC in our state is now considered cannabis. And so stores, retailers can only sell cannabis and paraphernalia. So they must be other than Chava products. They must be a detectable amount of THC in the product. And that's why we were trying to figure out what the level of detection needs to be so that so long as people are ensuring that there's a level of detection of these cannabinoids, then it's eligible for sale in the stores. If it doesn't have any THC in it, then it's not eligible for sale in the store. And so that's something that is a change from what we've previously saw in statute. So that's why we're kind of Looking at this particular issue, but yeah, if it's if it doesn't work, then you know, please let us know. And we'll be able to you know, have that conversation and assessment.
Yeah. Thank you for that. Yeah, anything, any of the thresholds or lists, or any of the things that we've included? We're very much, that's what we want your feedback on. So thank you. All right, it's 331. And I don't know about you, but I need a break. For 10 minutes, we're done for this session. Just to quickly to follow up, you have until May 15, to comment on these rules. And you can submit written comments to our rules and box. These are posted online, if you haven't already. If you don't have access, who would like access to them, you can put your email in if you haven't already in the chat box, and then tyranny, we'll make sure that you get the rules. Okay, with that, I'm going to just give everyone a couple of minutes, if you want to stay on I'll be available back at 340. And I just I really appreciate everyone's time. And thank you all, for developing this with us. I hope everyone has a good afternoon. All right.
So I will try to address next question because it came up a couple of times on 314 55 1025, we'll have to assess whether or not we can do that within this the scope of this rulemaking because the CR 101 demand dictates the scope, we recognize that there is going to have to be additional rulemaking around that lab transition to Department of Agriculture. So if it's not able to be put in here, we'll be having another real project to address that transitional purpose. So we recognize the concerns that you're raising, we're not sure if that can be built in to this area or not. The points that we did build into this particular rule set that modify some of the things that did go to, to Department of Agriculture really are a shift from, you know, a lab has to have something to a retailer has to ask the lab to test for these things, because it's incumbent upon the retailer to have that valid product that's coming to the market. And so that's where some of the shifts were able to be made. But as far as the full repeal, we'll have to look at that, whether we're whether or not we'll be able to build that into the scope. Without if we have to go back and redo the this year one on one, we'll likely just do a different rule set around that transition. So but we do acknowledge the point that you made.
Yeah, I'm, I'm sorry. I'm back and I'm here. So I'm just going to turn my camera off and sit here. And I will just, I'll give it until just another 10 minutes. If we don't hear anything that I'm going to go ahead and sign off. Again. Thank you all if I don't hear anything. And I hope you all have a great weekend. All right.
All right. Um, it's Ro. Justin. Thank you. Um yeah, thank you for clarifying that. That propone Joe um, so thank you again all for, for coming. If you think of anything afterwards, of course, a lot and we look forward to hearing from you. Have a great weekend and thanks again.
