[Melissa Jackson - OHA / ORELAP] 13:02:32 All right. Hello, everyone. Thank you again for being here. My name is Melissa Jackson, and I am the policy analyst and also a laboratory assessor. [Melissa Jackson - OHA / ORELAP] 13:02:42 Uh, with the Oregon Environmental Laboratory Accreditation Program, also known as ORLAP. [Melissa Jackson - OHA / ORELAP] 13:02:48 Today is Wednesday, August 19th, 2026, and this is the second Rules Advisory Committee meeting or RAC for cannabis, and the 1st Rules Advisory Committee meeting for psilocybin testing changes. [Melissa Jackson - OHA / ORELAP] 13:03:03 Today's meeting will cover Division 64. This rack is being held in coordination with Oregon's Medical Marijuana program, also a part of the Oregon Health Authority. [Melissa Jackson - OHA / ORELAP] 13:03:15 There was another rack yesterday, August 18th, for changes to Division 7, which covered proposed changes to testing roles for cannabis. [Melissa Jackson - OHA / ORELAP] 13:03:26 As a… just as a heads up, if we are not able to get into everything today in Division 64, we will have a third rack on Friday, August 21st, from 10 Am. To noon. [Melissa Jackson - OHA / ORELAP] 13:03:40 And that would cover mostly psilocybin. We're going to go through the cannabis rules first and then psilocybin after. [Melissa Jackson - OHA / ORELAP] 13:03:48 Um, the meeting materials for this meeting and others may be found on Orlaps rules and statute website, which may be found at www.healthoregon.org/ORLAP and selecting rules and statutes from the left sidebar. [Melissa Jackson - OHA / ORELAP] 13:04:04 The rules, as mentioned yesterday, are also on the OMMP website. [Melissa Jackson - OHA / ORELAP] 13:04:11 This meeting is being held over Zoom and is being recorded. [Melissa Jackson - OHA / ORELAP] 13:04:15 The recording will be posted on the ORLAP Rules website. [Melissa Jackson - OHA / ORELAP] 13:04:19 pleased to cut down on background noise. Everyone should place yourselves on mute when not speaking. That includes everyone calling in. Please remember to mute your phones. [Melissa Jackson - OHA / ORELAP] 13:04:31 The public is invited to listen to the RAC meetings, but only rack members may be involved in the discussion of the proposed rule changes during the RAC meetings. [Melissa Jackson - OHA / ORELAP] 13:04:42 The public will be able to provide comments on a final proposed rule draft at a later time. That information will be posted on ORLAPS and OMMP's rule pages. [Melissa Jackson - OHA / ORELAP] 13:04:53 The purpose of the rack is to increase the public's involvement in the development of administrative rules. [Melissa Jackson - OHA / ORELAP] 13:04:59 RAC meetings are a way to solicit input from internal and external stakeholders who are likely to be impacted by the development or amendment of agency policy rules. [Melissa Jackson - OHA / ORELAP] 13:05:10 RAC invites may include those impacted by the rules, such as OMMP registrants, Oregon Liquor and Cannabis Commission, or OLCC licensees. [Melissa Jackson - OHA / ORELAP] 13:05:20 Oregon Psilocybin services or OPS licensees, cannabis and psilocybin industry associations, members of the public, partner agencies, or other interested stakeholders. [Melissa Jackson - OHA / ORELAP] 13:05:36 The reason for having all these members on this committee today is to hear from different communities that may be impacted by the rules. [Melissa Jackson - OHA / ORELAP] 13:05:43 The RAC's role is advisory only and consensus is not necessary, but the RAC's input will be considered for possible integration into the rules, into the final rules. [Melissa Jackson - OHA / ORELAP] 13:05:56 RAC members are encouraged to communicate information or concerns to me or Margaret from OMMP. So if you have anything that you would like to say to us afterwards, feel free to reach out. [Melissa Jackson - OHA / ORELAP] 13:06:08 As an overview, the OHA is responsible for cannabis and psilocybin testing roles that apply both to medical. [Melissa Jackson - OHA / ORELAP] 13:06:15 For cannabis and retail market, any marijuana item intended to be sold at dispensary or retail shop must have been sampled and tested according to the testing rules found in Division 7 and 64, and any psilocybin product must have been sampled and tested according to the testing rules found in Division 333 and Division 64. [Melissa Jackson - OHA / ORELAP] 13:06:38 In today's RAC meeting, proposed changes to cannabis and psilocybin testing rules found in Division 64, also the associated exhibit C, table one and exhibit D table one and the statement of need fiscal impact statement and racial equity statement will be reviewed. [Melissa Jackson - OHA / ORELAP] 13:06:56 As we go through this today, I will review the changes in each section and ask for feedback from the rack. [Melissa Jackson - OHA / ORELAP] 13:07:03 Please use the raise hand function to be called upon before speaking. Before you begin speaking, please state your name for the record. [Melissa Jackson - OHA / ORELAP] 13:07:12 The record or the rack should provide meaningful feedback on proposed changes and the impact the change may have on you, your business or processes, any fiscal impact, equity impact or time it may take to implement a change. [Melissa Jackson - OHA / ORELAP] 13:07:27 Please be aware that the chat box is only available to send messages to hosts. [Melissa Jackson - OHA / ORELAP] 13:07:31 We will read applicable comments out loud to the rest of the committee. [Melissa Jackson - OHA / ORELAP] 13:07:36 Please be reminded that all comments in the chat box are public record. [Melissa Jackson - OHA / ORELAP] 13:07:41 We ask that everyone be respectful to everyone on the committee today, and as a reminder, this is a forum to discuss proposed rule changes. [Melissa Jackson - OHA / ORELAP] 13:07:50 The RAC meeting is not a time to introduce new topics that are not related to the proposed changes. [Melissa Jackson - OHA / ORELAP] 13:07:56 If these changes get adopted, they would be effective January first, st 2027. So any timeframes that should be considered for implementation should be brought forward and discussed. [Melissa Jackson - OHA / ORELAP] 13:08:09 If a fiscal or racial equity impact is identified for a particular section as we are reviewing it, please feel free to bring that up while we're reviewing that section. You don't have to wait till the end. You can bring it up at the end as well. But if you want to mention that while we're going over that section, please do. [Melissa Jackson - OHA / ORELAP] 13:08:27 Um, and the fiscal and racial equity impacts may also be stated at the end, or you can also send us an email afterwards as well. [Melissa Jackson - OHA / ORELAP] 13:08:37 We will take a 10 or 15 min break around the halfway point. This meeting is scheduled to go till 5 today. So if we may take that break around 3 pm. [Melissa Jackson - OHA / ORELAP] 13:08:49 Um, and to start us off, I'm going to do a roll call so we know who is here today. So when I call your name, please indicate you are here and who you represent. [Melissa Jackson - OHA / ORELAP] 13:09:02 So the 1st name I have is Jay Kirkwood, and I did get an email that he may not be able to make it. But, Jay, if you're here, please let us know. [Melissa Jackson - OHA / ORELAP] 13:09:18 Okay. The next name is Chris Griffey. [Chris Griffey] 13:09:26 Hi, Chris Griffey, I represent Rose City Labs as the lab director. [Melissa Jackson - OHA / ORELAP] 13:09:30 Great. Thank you. Megan Anderson. [Megan A] 13:09:35 Hi, Megan Anderson here, and I'm representing Pinnacle An [Melissa Jackson - OHA / ORELAP] 13:09:39 Thank you. Jeremy Sackett. [Jeremy Sackett] 13:09:44 Hi, Jeremy Second, present representing Columbia Laboratories. [Melissa Jackson - OHA / ORELAP] 13:09:48 And Patrick Trujillo. [Patrick Trujillo] 13:09:52 Hey everyone, Patrick Trujillo here representing Chem History, the lab director here. Thanks. [Melissa Jackson - OHA / ORELAP] 13:09:57 Thank you. And Justin Miller. [Justin M.] 13:10:02 Hi, Justin Miller, and I'm representing SC Labs. [Melissa Jackson - OHA / ORELAP] 13:10:05 Thank you. Daniel Hewson. [Daniel's S24 Ultra] 13:10:09 Daniel Hewson representing Rose City Laboratories. [Melissa Jackson - OHA / ORELAP] 13:10:13 Thank you. And Richard Holston. [Richard] 13:10:23 Richard representing Reference Labs. [Melissa Jackson - OHA / ORELAP] 13:10:26 Thank you. And Erin Purchase. [Erin Purchase] 13:10:30 Erin purchased managing member kindly Pend [Melissa Jackson - OHA / ORELAP] 13:10:33 Thank you. I'm Melissa Wolf. [Melissa Jackson - OHA / ORELAP] 13:10:47 Melissa Wolf. [Melissa Jackson - OHA / ORELAP] 13:10:52 All right. And I am working with one screen today, so I can't see the participants as easily as I could yesterday. So Melissa, if you're here, let us know. Otherwise, we'll move on. [Melissa Jackson - OHA / ORELAP] 13:11:04 Suzanne Silva. [Suzanne Silva] 13:11:08 Hi, Suzanne Silva representing Farmers Friend Extracts. [Melissa Jackson - OHA / ORELAP] 13:11:11 Thank you. April Roth. [April Roth] 13:11:16 Hi, April Roth representing Grown Rogue. [Melissa Jackson - OHA / ORELAP] 13:11:18 Perfect. Thank you. Alexander Maruki. [Alex Marucci - Higher Cultures / Gud Gardens] 13:11:23 Hey guys, Alex Marucci representing Higher Cultures and Good Gardens. [Melissa Jackson - OHA / ORELAP] 13:11:27 Thank you. Tucker Holland. [Tucker Holland] 13:11:32 Hi, Tucker Holland. I'm with Entourage Cannabis Processor. [Melissa Jackson - OHA / ORELAP] 13:11:36 Thank you. Mia Nelson. [mia] 13:11:40 Mia Nelson, owner and general manager of Capricorn. [Melissa Jackson - OHA / ORELAP] 13:11:44 Thank you. And Sienna or Oren Walker. [Siana Ọrun-Walker, I BE I AM INC.] 13:11:50 Hello, Siana Orun Walker representing IBIM Where Culture Meets Therapy. We are a mental health consulting firm. [Melissa Jackson - OHA / ORELAP] 13:11:58 Thank you. And Michael Rhodes. [Melissa Jackson - OHA / ORELAP] 13:12:10 Michael Rhodes, are you here? [Melissa Jackson - OHA / ORELAP] 13:12:15 Okay, we'll move on. But Michael Rhodes, if you're here, just chime in and let us know. [Melissa Jackson - OHA / ORELAP] 13:12:21 Patricia Butch Butcher. [Melissa Jackson - OHA / ORELAP] 13:12:31 Patricia Butcher. Okay, how about Anthony Taylor? [A Taylor] 13:12:40 Thank you, Melissa Anthony Taylor, Chair Oregon Cannabis Commission here to listen and learn. [Melissa Jackson - OHA / ORELAP] 13:12:46 Thank you. David Viencourt. [Melissa Jackson - OHA / ORELAP] 13:12:56 Okay. And Cheryl Johnson. [Melissa Jackson - OHA / ORELAP] 13:13:07 Okay, so not hearing Cheryl Johnson. So those those were the the last. That was all of the public members of the public committee members. We do have several state agency members on the line. [Melissa Jackson - OHA / ORELAP] 13:13:21 Um, so I'll go ahead and call those out as well. The first is Margaret Flirchinger. [Margaret Flerchinger] 13:13:27 Hi, everybody. Margaret Flirschinger, Oregon Health Authority, medical marijuana program policy analyst. Thanks [Melissa Jackson - OHA / ORELAP] 13:13:34 and David Standiford. [David Standiford (he/him) - OLCC] 13:13:39 Howdy, I'm with the Oregon Liquor and Cannabis Commission. [Melissa Jackson - OHA / ORELAP] 13:13:42 Thank you. And Dr. Sarah Volcker. [Sarah Voelker (she/her) - ODA] 13:13:50 Yes. Hi, I'm Sarah Volcker with the ODA Laboratory Services. [Melissa Jackson - OHA / ORELAP] 13:13:55 Thank you. And Jesse Sweet. [Jesse Sweet, OHA (he/him)] 13:14:00 Good afternoon. I'm Jesse Sweet. I use he/him pronouns. I'm with Oregon psilocybin Services section at OHA, and I'm a policy analyst. [Melissa Jackson - OHA / ORELAP] 13:14:11 Perfect. Thank you. And Steve Jedder. [Steve Jetter, OHA (he/him)] 13:14:15 Hi, everybody. Good afternoon. My name is Steve Jetter. I'm the program manager of Orlap and the manager of the regulatory section at Oregon State Public Health Laboratory. Thanks all for being here. [Melissa Jackson - OHA / ORELAP] 13:14:26 Thank you. And if is there any other State agency members that would like to announce themselves? [Melissa Jackson - OHA / ORELAP] 13:14:38 Okay. Well, thank you, everyone. We really appreciate you being here today. As I said yesterday was the Division 7 rack, and I believe there were some questions yesterday that some of the other State agency members may have some. [Melissa Jackson - OHA / ORELAP] 13:14:52 Follow up on that they might want to speak to before we get into Division 64, so… Margaret or David, if you would like to. [Melissa Jackson - OHA / ORELAP] 13:15:01 I guess we'll start with Margaret. Please go ahead. [Margaret Flerchinger] 13:15:06 Thank you, Melissa. So we're just going to go back to one section in Division 7. It was a comment brought up yesterday by Alex, and I sorry, Alex, I will ask you to kind of go over what you had proposed or suggested yesterday. And this is in regards to section 3, 3, 3. [Margaret Flerchinger] 13:15:28 Let me do a screen share too. 333-007-0430. Getting there with the screen share. [Margaret Flerchinger] 13:15:48 And we're here. [Erin Williams- Oregon DOJ] 13:15:49 Well, Margaret's doing that, Melissa, this is Erin Williams from DOJ, and I'm here too. [Melissa Jackson - OHA / ORELAP] 13:15:56 Thank you. [Margaret Flerchinger] 13:16:00 All right. So here we are in Division 7, Section 0, 4, 3, 0, standards for adult use cannabinoid and Cbd compliance testing. The specific comment that Alex made had to do with subsection 3. [Margaret Flerchinger] 13:16:16 which starts by stating, notwithstanding subsection 2a of this rule, which basically goes into items meeting Rpd. Rsd requirements. [Margaret Flerchinger] 13:16:32 And the comment was made specifically for botanical infused extract distillates. [Margaret Flerchinger] 13:16:41 And wanting to increase the amount of. possible milligrams of total Cbd, where an item would not fail testing based on the exceedance of Rpd or RSD. [Margaret Flerchinger] 13:16:55 So I just wanted to bring that comment forward. Alex did. Alex and I had a back and forth email about this after the rack. He indicated a fiscal impact of not meeting this. [Margaret Flerchinger] 13:17:08 Uh, if an item does fail and just wanted to bring it forward to see if there's any comments or. [Margaret Flerchinger] 13:17:17 feedback from the RAC members regarding this. Whether a goal change will happen right away is unknown. But we do want to take into consideration and comments that are made, and also for this particular section E that I keep pointing to, but I haven't. I don't think stated. [Margaret Flerchinger] 13:17:37 It's for cannabinoid concentrates, extracts, finished inhalable cannabinoid products or industrial hemp-derived vapor items. So when we do talk about these limits. [Margaret Flerchinger] 13:17:49 for not exceeding Rpd. If something is below a certain threshold for Cbd in this case, we do also need to take into account CBD dominant products or those industrial hemp-derived vapor items that might have more CBD. So this might be. [Margaret Flerchinger] 13:18:08 A bigger rule change than just saying, well, let's increase this number, or let's change our Pd or RSD. There's other factors to be taken into account as well. So I did want to put that out there. Alex, I'm not sure. Do you want to speak to this? [Margaret Flerchinger] 13:18:24 I don't. [Alex Marucci - Higher Cultures / Gud Gardens] 13:18:24 Yeah, it, you know, I've… I've never failed for RPD on a… on THC. Um, I've had… I believe, 3 failures in the past couple years, um, economic impact close to $100,000 of just. [Alex Marucci - Higher Cultures / Gud Gardens] 13:18:40 Batches that didn't make the market, um, because, you know, I mean, I gave an example. On March 4th, I had a test fail. Um, the primary tested at 1.96% CBD, the duplicate at 1.5%. [Alex Marucci - Higher Cultures / Gud Gardens] 13:18:58 4% CVD. I believe the difference in those two scores is extremely negligible, given the nature of CBD's effects on us. Um, it's not psychoactive. Um, the consumer, you know, is not going to get more or less high. [Alex Marucci - Higher Cultures / Gud Gardens] 13:19:15 Um, from… from those two numbers. Um, and so, yeah, it's just like, that's a very small… it's a .4%, uh, variation there, but because the starting number is so low, um, we failed as the RPD was roughly 22%. [Alex Marucci - Higher Cultures / Gud Gardens] 13:19:32 Um, and so… Just seems like… that's something that I've dealt with a handful of times, and if we could increase that to 100mg, like a 10%, uh, threshold, even a 5% threshold, I think is fair. [Alex Marucci - Higher Cultures / Gud Gardens] 13:19:51 Um, if 10 is too much of an ask. Um, but increasing that number to 50 or 100 milligrams, um… Would, uh… I think would be a little bit more fair for us, uh, given the nature of… [Alex Marucci - Higher Cultures / Gud Gardens] 13:20:05 CBD. I'm by no means asking to change the Rpd numbers, um, or, you know, affect any change to THC. I understand the intention there. Um, I just think this is… a bit of a gap for us, um… [Alex Marucci - Higher Cultures / Gud Gardens] 13:20:21 You know, and it has cost us some money, so… [Margaret Flerchinger] 13:20:27 Okay, thank you for that. I see a couple hand raised. So I think, Tucker, you were next. [Tucker Holland] 13:20:34 Yeah, I would just like to, um, um, jump in with there on Alex as another processor in the industry, we've had issues with lower levels of CBD as well, and that there has been a financial impact for us as well. So second, his request to to have something done here. Thank you. [Margaret Flerchinger] 13:20:54 All right. Thank you. And then, Patrick, you're up next. [Patrick Trujillo] 13:20:58 Yeah, thanks. I will say that I have had quite a number of clients basically reach out about this, um, for having those small amounts of CBD, so I'd be in favor of, you know, maybe looking at this, um, basically going up to maybe 50 milligrams, like Alex was saying. [Patrick Trujillo] 13:21:18 just because, you know, I said we're working with primarily THC products here, and the amount of Cbd for, you know, 15 milligrams even in a thousand milligrams is pretty much negligible [Margaret Flerchinger] 13:21:33 Okay, thank you. And Jeremy. [Jeremy Sackett] 13:21:37 Yes, thank you. I would also support this change. I think it would be a beneficial change. Maybe more complex than just changing some numbers. And just to put it out there, and I'm not sure how it would fit in, and it may require some. [Jeremy Sackett] 13:21:52 maybe more complicated than necessary, but it could incorporate the measurement uncertainty at the laboratory, depending on what the values are for the measurement uncertainty of the test method that may come into consideration as well, depending on what the test results were. [Jeremy Sackett] 13:22:08 Um, you know, that example that was shared. seems like those values are quite close, you know, and maybe. [Jeremy Sackett] 13:22:17 utilizing measurement uncertainty at the laboratory would would be helpful in sorting this out. [Jeremy Sackett] 13:22:22 Thank you. [Margaret Flerchinger] 13:22:24 Okay, great. Thank you. Anybody else have comments on this section? [Margaret Flerchinger] 13:22:40 All right. Not seeing any other hand raises. So this is something that we can take into consideration. We will look into it a little bit more. We'll look at some fail rates in metric and see what that looks like. [Margaret Flerchinger] 13:22:56 Obviously, with rules, items will fail. We we can't write rules to say that no items will fail. We do need to look at the why do we have this rule and the need for this role? And then, obviously, any other impacts fiscal. [Margaret Flerchinger] 13:23:13 that this may have. So we will take that into consideration and see see what happens. [Alex Marucci - Higher Cultures / Gud Gardens] 13:23:23 You guys, I appreciate you considering it. [Margaret Flerchinger] 13:23:24 and… Yeah, no problem. And that is all I really had to discuss. [Margaret Flerchinger] 13:23:32 Um, I know, uh, I had spoken to David at OLCC earlier today and he said he had some updates regarding metric and some of the questions that were asked around Division 7 yesterday. So I will actually turn it over to David to give those metric updates. [David Standiford (he/him) - OLCC] 13:23:47 Sure, so there were two rules we discussed where the question of how that would work in metric came up, and I did talk to our team, and I think we have some good ideas on how they would work, and I just kind of wanted to briefly explain it. [David Standiford (he/him) - OLCC] 13:24:06 Verbally, certainly, if the rules were to pass, we would write this up into the guide with pretty pictures and diagrams that explain all of this, so don't get too stressed if you aren't quite following. But this is generally how I imagine we would have it work. [David Standiford (he/him) - OLCC] 13:24:24 So, regarding target potency. What we would… what we could have done is when a target is out when a potency is outside of target, we would just give that a test name. [David Standiford (he/him) - OLCC] 13:24:43 Like, outside of target potency, something like that, and it would act like an R&D test, so it's not a pass-fail, it's just kind of an information-only status that would get entered in. [David Standiford (he/him) - OLCC] 13:24:55 And then that would let… the… the lab know that, okay, now we're going to do our reanalysis if they request it. Okay, boom. So, it shouldn't mess with the test status of the product. If the licensee just wants to relabel it. [David Standiford (he/him) - OLCC] 13:25:14 and give it a new pack… give it new packaging, they can do that. The test status should remain. If the licensee wants to do the reanalysis, and then have another lab come out and resample and retest if that… that first reanalysis. [David Standiford (he/him) - OLCC] 13:25:30 Uh, passes and is in the target range. Then, they'll just keep… they'll just do the sample test, enter that potency result, and that way it's very clear to the OLCC or to another license, even when they look at the test results, kind of what happened, which is, here's a series of passing tests. [David Standiford (he/him) - OLCC] 13:25:48 We see an outside of target potency test added. And then we see two more potency results. So we can see that reanalysis chain there. And you would just always use the most recent top level potency test result as what would be the label. [David Standiford (he/him) - OLCC] 13:26:07 Any questions about that part? [David Standiford (he/him) - OLCC] 13:26:12 Okay, um… The next one was how to deal with failures of potency when a single increment exceeds the potency limit. And I'm thinking kind of the same situation there, but we would just add a new test result or a new test type. [David Standiford (he/him) - OLCC] 13:26:32 That's just, you know, single increment or, you know, whatever we want to name it, increment outside of, uh… the allowable potency concentration, you know, we'll think of a shorter name. And so it'd be… that would be a pass-fail test. And so, just like thinking when you fail for a pesticide, that analyte gets entered, so a subtest of potency would be this. [David Standiford (he/him) - OLCC] 13:27:00 single increment exceeds concentration limit. that would get added, that would be marked as a fail, potency would be marked as a fail. So the THC is still reported as an average, just like is required in Division 64, but we would have this new test type that gets added that would identify the failure. [David Standiford (he/him) - OLCC] 13:27:23 So that's our solutions to that. [David Standiford (he/him) - OLCC] 13:27:30 Okay, that's all I wanted to explain. [Siana Ọrun-Walker, I BE I AM INC.] 13:27:34 Thank [Melissa Jackson - OHA / ORELAP] 13:27:35 All right. [Melissa Jackson - OHA / ORELAP] 13:27:43 All right. Thank you, Margaret and David, and thanks for those questions for everybody. With that we'll get into Division 64. [Melissa Jackson - OHA / ORELAP] 13:28:00 All right. Can everyone see my screen? Okay. Alright, so we are going to be starting with 333-064-0025. This is the definition section. [Melissa Jackson - OHA / ORELAP] 13:28:17 The 1st change that we have is kind of just editorial. So for cannabis sampling. [Melissa Jackson - OHA / ORELAP] 13:28:25 Um, we're changing the term. batch to have the same term as basically just to say this term has the same meaning given in 333-007-0310, and we didn't change the term at all. It's just this lines up with how it is in other sections. You can see in psilocybin sampling. It says the same thing there. [Melissa Jackson - OHA / ORELAP] 13:28:49 Um, so instead of having that definition in two places, we just start referring to Division 7 for that term to match up with how other definitions have been described in the rules. [Melissa Jackson - OHA / ORELAP] 13:29:05 Okay. The next change is adding a definition for cannabinoid product, and it's going to have the meaning given that term in 333 Division 7. [Melissa Jackson - OHA / ORELAP] 13:29:19 And I have that definition here. Again, not changing that definition at all. Just adding this definition to Division 64. [Melissa Jackson - OHA / ORELAP] 13:29:32 and then that did start a new numbering. So you see there's new numbering going down here as well. [Melissa Jackson - OHA / ORELAP] 13:29:45 So the next change is to the change of the definition of homogenization. [Melissa Jackson - OHA / ORELAP] 13:29:50 Um, so we. made the change. So homogenization means physically manipulating a sample to make the samples material uniform in composition and properties throughout. [Melissa Jackson - OHA / ORELAP] 13:30:02 and reducing particle size to a uniform material for biological tissue and solid matrices or combining all layers or phases of a liquid or semi-solid sample into a uniform substance. So we kind of took out that including, but not limited to. [Melissa Jackson - OHA / ORELAP] 13:30:19 To indicate that the homogenization really means reducing the particle size to a uniform material. And we'll talk more about that in the testing section as well. [Melissa Jackson - OHA / ORELAP] 13:30:31 Any comments on that? [Melissa Jackson - OHA / ORELAP] 13:30:39 Okay. We've added 2 new definitions. These are related to proficiency testing, and we'll talk a little bit more about this as well. But the 2 new definitions are ISO/IEC. [Melissa Jackson - OHA / ORELAP] 13:30:54 Uh, which stands for International Organization for Standardization and the International Electrochemical Commission. These are standards that they write a lot of standards for all different kinds of things. And one of the standards that they write is ISO IEC 17043. [Melissa Jackson - OHA / ORELAP] 13:31:14 Which is a general requirement for proficiency testing. And part of what we're going to be doing in this rack is expanding the allowable types of proficiency testing that psilocybin and cannabis fields of accreditation may use. [Melissa Jackson - OHA / ORELAP] 13:31:31 Um, in the past, this was limited to only TNI standard approved Pt providers. However, there are other options out there for cannabis and psilocybin, and we want to expand those options for labs, and we'll get into that more. [Melissa Jackson - OHA / ORELAP] 13:31:48 Because we're also changing the definition of proficiency testing. [Melissa Jackson - OHA / ORELAP] 13:31:54 And there is a link if you'd like to purchase that standard of where you can purchase it. [Melissa Jackson - OHA / ORELAP] 13:32:03 Okay. [Melissa Jackson - OHA / ORELAP] 13:32:09 So this next section is where we are updating the definition of proficiency testing. [Melissa Jackson - OHA / ORELAP] 13:32:14 Um, so it's going to now say proficiency testing or PT means for all fields of accreditation except as outlined in subsection B, the analysis of samples obtained for providers that meet the TNI standards for PT providers. [Melissa Jackson - OHA / ORELAP] 13:32:30 And so now we have this accept as for cannabis and psilocybin field of accreditation means the analysis of samples obtained from an ORLAP approved ISO/IEC 17043 accredited PT provider. [Melissa Jackson - OHA / ORELAP] 13:32:45 or a PT sample made by the Oregon Department of Agriculture Cannabis Reference Laboratory. So I do want to be clear, because we do have a couple labs here in the RAC and also who may be listening, that this change does not impact our environmental laboratories or environmental fields of accreditation. [Melissa Jackson - OHA / ORELAP] 13:33:05 Um, those types of testing will still need to use PT providers that meet TNI standards for PT providers. So those still need to be TNI approved PT providers. This is only a change for cannabis and psilocybin fields of accreditation. [Melissa Jackson - OHA / ORELAP] 13:33:22 Um, and I also want to point out that this is not going to change the in-matrix requirement for. [Melissa Jackson - OHA / ORELAP] 13:33:30 for pesticides, potency, and mycotoxins in biological tissue. So that will still need to be done. [Melissa Jackson - OHA / ORELAP] 13:33:40 by an in-state in matrix PT provider. It does leave the door open, though, if in the future a 17043 PT provider wants to also offer that, we'd be open to that, but we're not changing that in matrix. [Melissa Jackson - OHA / ORELAP] 13:33:55 This is for the rest of the testing. And is there any feedback or input on this? [Melissa Jackson - OHA / ORELAP] 13:34:06 Yes, Daniel. [Daniel's S24 Ultra] 13:34:09 Hey there, I just wanted to touch bases, yes, um, Daniel, Rose City Laboratories. I just I'm thankful that you mentioned that it had to be in Matrix PT type scenarios, because there's only one for psilocybin right now, and it's not. [Melissa Jackson - OHA / ORELAP] 13:34:14 Hmm. [Daniel's S24 Ultra] 13:34:25 In Matrix, it's button mushrooms, and I think we all know how that worked for the cannabis industry when we started not being in Matrix. But anyway, I just… Um, that was my concern over all of this, is just making sure that it's a legit PT or something that's in Matrix. Thanks. [Melissa Jackson - OHA / ORELAP] 13:34:26 Hmm. [Melissa Jackson - OHA / ORELAP] 13:34:44 Thank you, Daniel. Yeah. And at this time we we still actually don't have a Pt requirement for psilocybin, and partly is because of what you stated. There's only one provider. It's not really in matrix, but this is written in case in the future. We will add that. We just want to. [Melissa Jackson - OHA / ORELAP] 13:35:01 change that definition. Now, I also want to say, like, at this time, the Department of Agriculture Cannabis Reference Laboratory is not yet to the point of making PT samples, but it's in statute that they can someday. So we're just making that change now in anticipation that they that that. [Melissa Jackson - OHA / ORELAP] 13:35:18 will happen in the future. [Melissa Jackson - OHA / ORELAP] 13:35:26 All right. Any other? Any other comments? And Daniel Dan, did you still want to have your hand up there? [Melissa Jackson - OHA / ORELAP] 13:35:41 Jesse, go ahead. [Jesse Sweet, OHA (he/him)] 13:35:42 Yeah, I'll just add very briefly. Thank you for that clarification. You answered my question before I had an opportunity to ask it. [Melissa Jackson - OHA / ORELAP] 13:35:52 Great. Okay, this is a big change, but it puts Oregon in line with what other states are requiring for Pts, and we hope it opens up more options for labs on PT providers. [Melissa Jackson - OHA / ORELAP] 13:36:15 Um, so the next one is adding a definition for target potency. Again, this is not a new definition. We're just adding this definition from. [Melissa Jackson - OHA / ORELAP] 13:36:26 OAR 845-025-7000. And it's, you know, we talked about target potency yesterday. It'll come up a little bit again in Division 64, and we're just making sure that definition of target potency is clear in these rules. [Melissa Jackson - OHA / ORELAP] 13:36:48 All right. And then the next change is for psilocybin. I am going to go over this now. We will touch on it again when we talk about psilocybin. Oh, go ahead, Tucker. [Tucker Holland] 13:37:03 Sorry, this… this might back us up just a little bit, but there's a lot. But but it looks like if if Oregon and OHA is going to start requiring the ISO IEC standardization. [Tucker Holland] 13:37:19 Where are we with allowing licensees, even of low TAC products to use any lab that is accredited with that association, even if that's an out of state lab? [Melissa Jackson - OHA / ORELAP] 13:37:32 So thanks for your question. So just to be clear, the TNI Pt providers are also ISO IEC. So right now there's 3 Tnipt providers for cannabis Pts, and they also have that they also have that 17043. [Melissa Jackson - OHA / ORELAP] 13:37:51 accreditation. So. This is just adding more. But for your specific question about out of state low potency things, the rules here are written for in-state cannabis testing. So that this is not really written for those questions, and that might be more of a question for the Oregon Department of Agriculture. [Tucker Holland] 13:38:17 Thank you. [Melissa Jackson - OHA / ORELAP] 13:38:19 Okay. [Melissa Jackson - OHA / ORELAP] 13:38:25 Okay. Um, so for our changes for psilocybin, psilocybin services had a work group around this, and this change is in coordination with Oregon Psilocybin Services. [Melissa Jackson - OHA / ORELAP] 13:38:39 Um, we are changing the definition of total potential psilocin to total psilocybin equivalent, and that will mean the sum of psilocybin analyte concentration and 1.4 times the psilocin analyte concentration. [Melissa Jackson - OHA / ORELAP] 13:38:55 Um, and this number is the maximum theoretical concentration of psilocybin in the sample. [Melissa Jackson - OHA / ORELAP] 13:39:07 and we will talk about this more when we get to the psilocybin section. This is just making sure that definition is clear. [Melissa Jackson - OHA / ORELAP] 13:39:18 Okay. [Melissa Jackson - OHA / ORELAP] 13:39:23 All right. And that is the end of the changes to the definition section. Does anyone have any comments before we move on? [Melissa Jackson - OHA / ORELAP] 13:39:36 Great. Okay. All right, this is one of the bigger sections. So this is cannabis sampling procedures and testing. This is 333-064-0100. [Melissa Jackson - OHA / ORELAP] 13:39:52 And it covers sampling and testing throughout the document. We're making some just kind of editorial changes. [Melissa Jackson - OHA / ORELAP] 13:40:03 Historically, there used to be this El. Oh, go ahead, Mia. [mia] 13:40:10 Oh, I didn't… I didn't mean to cut you off. I can share a presentation. I was just getting in line for comments. [Melissa Jackson - OHA / ORELAP] 13:40:14 Oh. Okay, thank you. I'll I'll come back to you. So we'll have. [Melissa Jackson - OHA / ORELAP] 13:40:21 T and I, we're removing this El. It was kind of historic. We're also before this was called Vf1m1. We're just spelling out the words volume and module here. And then throughout the document we're changing, um… They used to say Rev, and now we're just changing it to revision just for clarity. [Melissa Jackson - OHA / ORELAP] 13:40:44 Here for this section F. It was missing a section. So it used to say oar. 33370330 3 4 0. And now we're adding 3, 4, 1. I don't think this changes the intent. It was just a clarification there. [Melissa Jackson - OHA / ORELAP] 13:41:01 that that 341 was also included. Um, throughout the document, we had, or we had this phrase Oregon Liquor and Cannabis Commission seed to sale system. [Melissa Jackson - OHA / ORELAP] 13:41:15 Um, and we're just shortening that to CTS, because that matches what's in our definitions. You're going to see that throughout the document. [Melissa Jackson - OHA / ORELAP] 13:41:24 Um, and then Margaret covered this yesterday, where when they go, when the laboratory takes the sample, they should be… they need to take for analysis and potential reanalysis. So this is just matching that as well. [Melissa Jackson - OHA / ORELAP] 13:41:40 Um, and then as Margaret mentioned yesterday, we're changing all shalls to must. Again, doesn't change the meaning, it's just kind of an editorial thing to kind of get in line with, uh. [Melissa Jackson - OHA / ORELAP] 13:41:52 With the more standardized way of defining those rules. [Melissa Jackson - OHA / ORELAP] 13:41:58 All right. I think this is a good breaking point. Mia. Do you want to say your comment here? [mia] 13:42:05 Well, you haven't covered the section that I had a concern with, so I I was premature raising my hand. Sorry about that. [Melissa Jackson - OHA / ORELAP] 13:42:10 Okay. No problem. Just let it let me know when you're ready. [Melissa Jackson - OHA / ORELAP] 13:42:19 All right. Any comments about those sections that we just covered? [Melissa Jackson - OHA / ORELAP] 13:42:31 We did a little bit of renumbering here. This in this 1st section 2 of Section 100 was getting pretty long, and it sometimes wasn't clear where the sampling portion ended and the sample handling and homogenization sections began. [Daniel Huson] 13:42:32 We did a little… [Melissa Jackson - OHA / ORELAP] 13:42:48 Um, so we just added a new number 3 here to make it clear that the sampling portion is above, and Section 3 and below is after the sample has been collected, and you're handling and homogenizing the section, the sample. [Melissa Jackson - OHA / ORELAP] 13:43:07 Um, so now we're getting into getting back to that homogenization section. We are adding some new requirements for how the lab needs to homogenize usable marijuana. [Melissa Jackson - OHA / ORELAP] 13:43:20 And. of people could remember to mute themselves. [Melissa Jackson - OHA / ORELAP] 13:43:26 Thank you. So we have. We have 3 now little a prior to any testing or sub sampling, except as described in subparagraph B of this paragraph, the entire sample combined sample, except as described in subparagraph D of this paragraph must undergo the laboratory's homogenization. [Melissa Jackson - OHA / ORELAP] 13:43:46 process. And so we now have. subparagraph A, which is new. It says the laboratory's homogenization process for usable marijuana must make the entire sample uniform to less than 1.0 millimeters. The laboratory must not remove stems, seeds, or leaf material prior to the homogenization process. [Melissa Jackson - OHA / ORELAP] 13:44:08 The laboratory must perform and document an initial validation to demonstrate the laboratory's homogenization process for usable marijuana achieves a sample uniformity of less than 1.0 millimeters. And yes, Patrick, please. [Patrick Trujillo] 13:44:24 Yeah, thanks. I'd like to suggest maybe 5 millimeters, just because some of the things can get real sticky when they're being stored, not necessarily right after cryo, but when they're being stored, they can get a little sticky and kind of ball up. Other thing is sometimes those stems can be a little bit pesky, too. [Patrick Trujillo] 13:44:41 So I just, I think one millimeter might be a little ambitious. 5 millimeters is, in my opinion, still small enough. So I like to suggest maybe 5 millimeters instead. But I do like the additional clarity about sample or. [Patrick Trujillo] 13:44:58 size and uniform and whatnot. [Melissa Jackson - OHA / ORELAP] 13:45:00 All right. Thank you for the comment, Patrick, and and Mia, go ahead. [mia] 13:45:04 Um, regarding the, um, the STEM seeds and leaf material. I am not sure what all labs do currently, but I have been told by one of my partners that usually large stems get removed before running. And if that's the current practice of labs, I really think that should continue, because, you know, fair enough with the leaf material that should have been. [mia] 13:45:30 off by the trimmers and seeds shouldn't be in there at all. But when people buy whole buds at the dispensary, they fully know that there's a stem in there, and furthermore, they even know, like, how large the stem is likely to be, because the bigger the bud is, the bigger the stem is. Nobody smokes those, and so I think it's really inappropriate for that to be sampled because that expectation is our. [mia] 13:45:55 already part of, you know, what the consumer has when they purchase the product. [Melissa Jackson - OHA / ORELAP] 13:46:00 Okay, thank you for your comment, Mia and and Tucker. [Tucker Holland] 13:46:06 Yeah, I'd like to, um… echo what Mia said there, but also, um, if we're removing the stem, we could potentially be artificially deflating the testing of the product, or sorry, inflating the testing of the product. Um, and a consumer may think they're getting something that's lower in potency, because that stem was included in the testing. [Tucker Holland] 13:46:29 Um, and then they get a product that's stronger on… in the market once they remove that stem. So, uh, I believe the testing should actually mirror kind of what Mia was saying, how the consumer is actually consuming that product. And so we don't want to necessarily be artificially deflating these test results. [Melissa Jackson - OHA / ORELAP] 13:46:50 Okay, thank you for your comment. And Justin. [Justin M.] 13:46:55 Yeah, just mostly want to echo what most other people said here. I agree with the stems and the reasonings, and I also agree with the maybe increasing the one millimeter, because that does. That does seem a little small, and like I think Patrick mentioned, it does kind of get sticky, or when it's stored. [Justin M.] 13:47:11 And I guess I was just curious, too, where did the 1mm come from? Was that just an arbitrary number, or was that? I just just kind of curious where that number came from as well. [Melissa Jackson - OHA / ORELAP] 13:47:20 Yeah. So if in the in the statement of need and fiscal impact. We have some supporting documents, and I believe one of those supporting documents was sent to the RAC members to just show that well, for one, there's an Astm standard. An Astm is an organization that writes standards for. [Melissa Jackson - OHA / ORELAP] 13:47:39 Again, all different kinds of things, including testing. And their homogenization standard for usable marijuana does specify the one millimeter. And then we also shared a study that showed kind of how precision and accuracy changes. [Melissa Jackson - OHA / ORELAP] 13:47:57 Um, in relation to homogenization size. And that paper actually concluded that it was 0.5 millimeters that would give the best accuracy and precision, which I believe. [Melissa Jackson - OHA / ORELAP] 13:48:10 we felt was a little too low. But yeah, so that number did come from some supportive documents. But we do hear you, and we will take what your comments into consideration for the final rule. [Melissa Jackson - OHA / ORELAP] 13:48:33 Anyone else? [Melissa Jackson - OHA / ORELAP] 13:48:38 Jeremy. [Jeremy Sackett] 13:48:41 Hi. Yes, thank you. Jeremy second here. I know this is specific to usable marijuana in this section, and maybe down the document further. Does it address other types of products, edible products, or things along those lines with. [Jeremy Sackett] 13:48:56 changes to homogenization. [Melissa Jackson - OHA / ORELAP] 13:48:58 It doesn't. We'd welcome that feedback, but for right now, it's usable marijuana. I could see this being applied to other edibles, product, solid product types as well. Also, Jeremy, you're a little quiet, so I don't know if you have another comment, if you could. [Melissa Jackson - OHA / ORELAP] 13:49:14 turn up a little bit. Thanks. All right, Dan. [Jeremy Sackett] 13:49:14 I'll speak. I'll speak up. Thank you for letting me know. [Daniel Huson] 13:49:20 Hi, Dan Hewson, Rose City. I would love to not homogenize stems and all of that stuff that it's not consumed. It's not anything. So I agree with the not homogenization of stems, but the leaves and seeds, I mean the grower can't grow without it, then probably because they may be consumed. [Melissa Jackson - OHA / ORELAP] 13:49:40 Okay, thank you, Dan. [Melissa Jackson - OHA / ORELAP] 13:49:44 Anyone else? [Melissa Jackson - OHA / ORELAP] 13:49:52 Okay, we'll move on. So the next B that this has not changed. Talking about. [Melissa Jackson - OHA / ORELAP] 13:50:02 Yeah, so that part has not changed. But but subsection C before it just said potency must not be performed on material subsampled prior to homogenization. We're just clarifying that, you know, pesticides, mycotoxins, solvents, heavy metals. [Melissa Jackson - OHA / ORELAP] 13:50:18 would also be things that would not be impacted by the cryogenic sterilization and should be performed on homogenized material. Go ahead, Patrick. [Patrick Trujillo] 13:50:31 Thanks, sorry, I realized I had one more comment about Sub A, and it's just at the very, very, very end where it says basically we need to have a validation to ensure uniformity. It just says of less than one millimeter. [Melissa Jackson - OHA / ORELAP] 13:50:35 Okay. [Patrick Trujillo] 13:50:46 But immediately above, it says less than or equal to, and I don't want to… I hope to have the same less than or equal to there, just to for clarity and consistency sake. [Melissa Jackson - OHA / ORELAP] 13:50:51 Hmm. [Melissa Jackson - OHA / ORELAP] 13:50:58 That's thank you. I will add that in. That's a good catch. Thank you. [Melissa Jackson - OHA / ORELAP] 13:51:07 All right. And then again, we just have another shall being changed to a must here. [Melissa Jackson - OHA / ORELAP] 13:51:18 Okay, any other comments? [Melissa Jackson - OHA / ORELAP] 13:51:24 Okay. Again, just changing rev to revision shall to must. [Melissa Jackson - OHA / ORELAP] 13:51:32 Um, this next section here is about, I believe it's been called like composite testing, but basically when the laboratory goes and takes samples of different. [Melissa Jackson - OHA / ORELAP] 13:51:44 strains or different batches, but then those batches are within the same harvest lot, and they're allowed to be combined for contaminant testing. This was a section. It basically reiterates what was in an Olcc guidance document. [Melissa Jackson - OHA / ORELAP] 13:51:59 But has never been in rural that says when you combine the homogenized sample for testing as permitted in Division 7, a proportionally representative amount of material must be withdrawn from each homogenized sample, and then the withdrawn material from each sample must be combined to produce the combined sample. [Melissa Jackson - OHA / ORELAP] 13:52:18 And that, um… that when you withdraw that sample, you have to combine it, and you have to document how much came out from each. [Melissa Jackson - OHA / ORELAP] 13:52:29 sample. So this is kind of just putting something into a rule that has been in a guidance document, but not been in rule. [Melissa Jackson - OHA / ORELAP] 13:52:44 Okay, any comments on that? [Melissa Jackson - OHA / ORELAP] 13:52:50 Okay. Uh, we do have, yeah, again, some more shells turning into muss. And then another change that we're making throughout the document is changing the word average to mean average can have 3 different meanings. It can mean the mean, which I think is what we all think of when we say average. [Melissa Jackson - OHA / ORELAP] 13:53:09 Then it can also have the median, which is like the middle result, and then it can also have the mode, which is the result that comes up most frequently. And this is just a clarification that by average we actually meant mean. [Melissa Jackson - OHA / ORELAP] 13:53:29 Okay. [Melissa Jackson - OHA / ORELAP] 13:53:33 here that we just, I added some little parentheses around PCR that had been missing. [Melissa Jackson - OHA / ORELAP] 13:53:38 And here I just added — it was added that Loq just for. [Melissa Jackson - OHA / ORELAP] 13:53:44 ease of looking up that if you're looking up limit of quantitation, LOQ is the common acronym for that. [Melissa Jackson - OHA / ORELAP] 13:53:53 Okay, so with with Lcs, this has been in the rule for a while. We're making one small change that says changing acceptable performance means recovery. [Melissa Jackson - OHA / ORELAP] 13:54:05 are within limits to must be within limits, just to make that more clear. [Melissa Jackson - OHA / ORELAP] 13:54:11 And then this was a section here that is new. I'll read through it. So the laboratory control sample or Lcs may be made and characterized by the laboratory for potency testing only. [Melissa Jackson - OHA / ORELAP] 13:54:25 The LCS characterization protocol must include at least seven replicates. The laboratory must calculate and document the mean and standard deviation of the replicates. The assigned value of the characterized LCS must be the mean of the replicates. [Melissa Jackson - OHA / ORELAP] 13:54:40 If the characterized LCS fails during routine analysis and the laboratory intends to recharacterize or remake the characterized LCS, the laboratory must perform and document an investigation into the cause of the failure prior to recharacterizing the Lcs. [Melissa Jackson - OHA / ORELAP] 13:54:55 to demonstrate the LCS failure is not due to laboratory error. [Melissa Jackson - OHA / ORELAP] 13:55:00 And I think what this is saying is, like, if your LCS is failing, you should look into why it's failing and not just assume that the material itself is failing, that there may be something else that went wrong. The Lcs are used to determine acceptability of test batches. [Melissa Jackson - OHA / ORELAP] 13:55:18 And the characterization of the LCSs has been something that's been… that labs have been doing since the beginning. But we just wanted to put some requirements around that and make sure labs were all had some consistency in that. [Melissa Jackson - OHA / ORELAP] 13:55:33 Oh, yeah, Chris, go ahead. [Chris Griffey] 13:55:37 Uh, yes. Uh, you say if the laboratory intends to recharacterize or remake the first part of the sentence, and then… Uh, do the investigation. [Chris Griffey] 13:55:47 Prior to recharacterizing, but not prior to remaking. that. [Melissa Jackson - OHA / ORELAP] 13:55:51 We'll add that in, too. Yeah, that's a good catch there for consistency. [Chris Griffey] 13:55:54 Okay. [Melissa Jackson - OHA / ORELAP] 13:55:56 Thank you. [Melissa Jackson - OHA / ORELAP] 13:56:05 Anyone else? [Melissa Jackson - OHA / ORELAP] 13:56:12 Okay. So these next sections are also new. [Melissa Jackson - OHA / ORELAP] 13:56:19 So, and they also relate to exhibit C, table one, which will cover at the end here. Actually, maybe we'll cover it now, because we're talking about it now. But so the new requirement is to run an initial calibration verification, also known as an Icv. [Melissa Jackson - OHA / ORELAP] 13:56:38 For each initial calibration in accordance with TNI standard requirements, an acceptable performance of the ICV means percent recovery for all regulated analytes must be within the limits specified in Exhibit C, table one. [Melissa Jackson - OHA / ORELAP] 13:56:52 Also run continuing calibration verification, otherwise known as Ccv. In accordance with Tni standard requirements, acceptable performance of a Ccv. Means percent recovery for all regulated analytes must be within the limits specified. [Melissa Jackson - OHA / ORELAP] 13:57:07 And exhibit C, table one. and I am going to pull up Exhibit C. Table one now. [Melissa Jackson - OHA / ORELAP] 13:57:24 And so this table should be familiar. The Lcs limits have been there the whole time, and we're not changing any of the Lcs limits. [Melissa Jackson - OHA / ORELAP] 13:57:34 Um… This is a little bit hard to read because we also are adding those trailing zeros to this. But essentially what's happening is adding the trailing zeros to the LCS limit so that now that must be within includes those trailing zeros. And then the new part is the ICV and CCV limits. [Melissa Jackson - OHA / ORELAP] 13:57:54 Um, they don't… for pesticides, it's going to be 70 to 130 for each analyte. That's the proposed change. [Melissa Jackson - OHA / ORELAP] 13:58:06 And then for… solvents, it will be 60 to 120 is the proposed change which matches the Lcs limits for solvents. [Melissa Jackson - OHA / ORELAP] 13:58:20 the Icv. Ccv limits for potency proposed change is 90 to 110, again, matches the limits for Lcs for heavy metals. It's the proposed change is 90 to 110. [Melissa Jackson - OHA / ORELAP] 13:58:34 And then for mycotoxins, same as pesticides. It's 70 to 130. And then we're also adding a requirement for water activity for 95 to 105. And I will say many of these limits came from an ACIL. [Melissa Jackson - OHA / ORELAP] 13:58:50 White paper or guidance document on cannabis testing. These were the limits that they had. And then with the acceptance of heavy metals came actually from EPA 200.8, which was a standard that many of our labs, our environmental labs use for water testing. [Melissa Jackson - OHA / ORELAP] 13:59:07 Go ahead, Patrick. [Patrick Trujillo] 13:59:11 Hi, yeah, thanks. Um, I mean, all of them match those of the LCS recoveries, except for heavy metals, and just for consistency's sake, I'd like to suggest we make those match the 80 to 115 instead of 90 to 110. Again, just for consistency and clarity's sake. [Melissa Jackson - OHA / ORELAP] 13:59:29 Thanks. I will point out that the pesticides also don't necessarily match. They're a little tighter than the Lcs limits. [Melissa Jackson - OHA / ORELAP] 13:59:39 And part of the reason for that is because the Lcs is done in a in matrix material. So there may be some matrix effects where the Icv and Ccv are essentially clean standards just done in solvent. So you would see less matrix effects. [Melissa Jackson - OHA / ORELAP] 13:59:56 And also the the ICV, the purpose of that is to prove that your calibration is in control when you first calibrate that initial calibration verification, and then the continuing calibration verification is to prove that the calibration of the instrument continues. [Melissa Jackson - OHA / ORELAP] 14:00:14 Um, to be within limits. But yes, I do hear your comments on that. We'll take that into consideration. [Melissa Jackson - OHA / ORELAP] 14:00:24 Does anyone else have any comments on this? Justin, go ahead. [Justin M.] 14:00:29 Yeah, I was just curious. Just more of a curiosity. Why some some elements seem to be like plus or minus 30%, and others are minus one minus 40, but plus 120. Why? They're not the same on the on either end. If they're just just out of curiosity. [Melissa Jackson - OHA / ORELAP] 14:00:46 So that is a good question. I do believe it has to do with the performance of those specific analytes. I may ask Steve Jedder to comment on this. These roles have been in place for quite some time. [Melissa Jackson - OHA / ORELAP] 14:00:59 And he would know kind of more the background on those LCS limits. [Steve Jetter, OHA (he/him)] 14:01:04 Yeah, thanks, Melissa. Hey, everybody. This is Steve Jetter. For the record with with orlap. [Steve Jetter, OHA (he/him)] 14:01:09 Yeah, the original LCS limits were partially based on either existing standard methods, EPA methods for the same analyte types using the same technologies like LC triple quad or GC triple quad. [Steve Jetter, OHA (he/him)] 14:01:26 Um, or ICPMS. And for for some of those we we pulled labs at the time we had a bit of a work group and kind of determined some of our analytes that are maybe less frequently, um. [Steve Jetter, OHA (he/him)] 14:01:42 Incorporated into standard methods outside of cannabis testing for which analytes had particular issues, particularly in these matrices. And for residual solvents, I think we sort of all all of us know who have. [Steve Jetter, OHA (he/him)] 14:01:58 who have tried to analyze any of these analytes, they do tend to, especially the light end, analytes can be lost as part of handling of them. And so that's part of the reason why residual solvents especially has these. [Steve Jetter, OHA (he/him)] 14:02:14 broader limits at the lower end, rather than at the higher end, because they do tend to have a lower recovery rather than a higher recovery. I think it's maybe worth. [Steve Jetter, OHA (he/him)] 14:02:26 comment from labs if, um, if those limits either could be tighter or for CCVs, rather than an LCS, or if there are other considerations, I know that in some cases, the laboratory information management systems, the LIMS. [Steve Jetter, OHA (he/him)] 14:02:44 have a hard time with, um, control limits that aren't equally equally spaced around the true value. So 70 to 130 plus or minus 30 works. But 60 to 120 doesn't work as easily within a limbs. So if that's a consideration that we should have. [Steve Jetter, OHA (he/him)] 14:03:02 For these, please share those with us at this time. But that's kind of the the basis for why these limits are the way they are right now. [Steve Jetter, OHA (he/him)] 14:03:11 And I will say, too, for heavy metals in particular, the difference between, you know, a digested sample and a clean run CCV on an ICPMS. [Steve Jetter, OHA (he/him)] 14:03:25 are pretty… there's quite a lot of difference that can occur there. And because metals are so stable, which is why the reason that we're looking for them, that's part of the reason why we have those limits that are more aligned with the EPA 200.8. [Steve Jetter, OHA (he/him)] 14:03:41 ICPMS method of plus or minus 10%. [Melissa Jackson - OHA / ORELAP] 14:03:46 Thanks, Steve. And I will say one of the reasons we're making this change is just to ensure labs are using the same limits in their methods and kind of moving labs into more of a performance-based method, ensuring the and these are not new requirements for those who may not be as familiar with the lab testing world. [Melissa Jackson - OHA / ORELAP] 14:04:08 The labs were always required to run an ICV and CCV. They were able to set their own limits, so we're just adding, making sure all labs are using the same limits for that. [Melissa Jackson - OHA / ORELAP] 14:04:24 Go ahead, Chris. [Chris Griffey] 14:04:26 Uh, yeah, I just wanted to, uh, say what Steve had mentioned. With our current limbs right now would be… it is more difficult to flag a non-standard number around a CCV or an ICV. [Chris Griffey] 14:04:39 Uh, the blank spike, the metric spike, that's easy to do, but CCPs and ICP is not so much. [Melissa Jackson - OHA / ORELAP] 14:04:51 Yeah. And I think I believe all of. Oh, I guess the ICV and Ccv limits for solvents are not symmetrical. So we. [Melissa Jackson - OHA / ORELAP] 14:04:58 Uh, that is something to take into consideration. Thanks for bringing that up. [Melissa Jackson - OHA / ORELAP] 14:05:10 Okay. I'm going to move on unless anyone else has anything else to share on this. [Melissa Jackson - OHA / ORELAP] 14:05:27 Okay, so as Margaret said yesterday, we're adding those trailing zeros throughout the documents. Just to make those limits clear. [Melissa Jackson - OHA / ORELAP] 14:05:41 This is a new section that's been added. I'm just going to read through it. So this is specific for this is specific for marijuana or usable marijuana for potency. [Melissa Jackson - OHA / ORELAP] 14:05:52 Um, so the new rule says that the collected sample may be analyzed more than once by the same laboratory. Once the sample is tested by a laboratory for potency, the laboratory may not subcontract additional potency testing to another laboratory. [Melissa Jackson - OHA / ORELAP] 14:06:08 All potency results obtained must be used to calculate a mean result of each adult use cannabinoid and CBD analyte. [Melissa Jackson - OHA / ORELAP] 14:06:16 Um, the laboratory must have a minimum of 3 potency test results to calculate a mean result as the reported. [Melissa Jackson - OHA / ORELAP] 14:06:24 adult use cannabinoid and CBD results. If the laboratory determines a potency result is an outlier, the laboratory must have a documented scientific justification, such as a grubs outlier test for excluding the outlier result. The outlier result must be excluded for all potency analytes, not just the potency analytes that are determined to be outliers. [Melissa Jackson - OHA / ORELAP] 14:06:45 And I will say, before we get into comments, there is a section further down in the prohibited testing activities which prohibits averaging of results for anything other than usable marijuana for potency. So while this section doesn't say that we will cover it later. [Melissa Jackson - OHA / ORELAP] 14:07:03 This is… providing rules around when it's okay to average and how to average results. [Melissa Jackson - OHA / ORELAP] 14:07:29 Okay, I'm not hearing anything. This is a fairly big change. So again, if something, if you think of something later, please let us know, and I will say, go ahead, Justin. [Justin M.] 14:07:40 Uh, yeah, just one thing. It's… so it seems to say that if we had to do a retesting for a usable, we would automatically have to do 3 like a total of 2 retest, because we would need 3 to average to report the mean. Essentially. [Melissa Jackson - OHA / ORELAP] 14:07:54 Yeah, that's what it's saying. which I do welcome feedback on that. [Justin M.] 14:07:56 Okay. [Melissa Jackson - OHA / ORELAP] 14:08:04 And I will say one of the there is in the sniffy. We did reference the New York quality manual for cannabis, and in their quality manual they actually want all potency of marijuana, of usable marijuana to be done in triplicate. [Melissa Jackson - OHA / ORELAP] 14:08:21 and to report the average. and that was one of the references that we used to help write this rule. [Margaret Flerchinger] 14:08:32 And Melissa, just to clarify, or maybe you can speak more to it. [Margaret Flerchinger] 14:08:38 This is not necessarily just for retesting. This could be an initial test that's run as well. [Melissa Jackson - OHA / ORELAP] 14:08:45 Right. So I guess I'm not always clear on what the word retest means. So this would be like before the results are reported. [Melissa Jackson - OHA / ORELAP] 14:08:53 Not after. Go ahead, Chris. [Chris Griffey] 14:08:59 Yeah, so I just want to get some clarification, because it doesn't sound like you're requiring it. [Melissa Jackson - OHA / ORELAP] 14:09:04 No. [Chris Griffey] 14:09:05 But if we wanted to run a sample more than once to get a mean to result, we would have to run it at least 3 times. [Chris Griffey] 14:09:16 But, uh, if we just suspected a wrong result and reran it once. [Melissa Jackson - OHA / ORELAP] 14:09:16 Yeah. [Chris Griffey] 14:09:22 Got about the same. We go with the first one. We don't have to repeat, uh, report the mean at that point, right? [Melissa Jackson - OHA / ORELAP] 14:09:29 This is not saying that you do, no, but that is something we may consider. [Melissa Jackson - OHA / ORELAP] 14:09:35 I think the idea is that any result that you test would be included. [Melissa Jackson - OHA / ORELAP] 14:09:42 And you would want that 3rd result just to. [Melissa Jackson - OHA / ORELAP] 14:09:46 kind of back up the result. [Melissa Jackson - OHA / ORELAP] 14:09:52 Megan. [Megan A] 14:09:55 Hey, Megan with Pinnacle. Uh, just to clarify, if the first test maybe was higher than expected, and it fell outside a calibration range, would we have to do two additional tests, or would just one suffice, doing, like, a new dilution factor to get it in the range? [Melissa Jackson - OHA / ORELAP] 14:10:10 I think if it's an error, then yeah, you would just follow your normal error processes. And and I think we could write this rule more clearly. This is kind of a brand new rule. But yeah, if there's like, in my opinion, if there was an error like an like a it was over the dilution range, and then you just diluted it. That's not a situation where you'd have to average the results, because that 1st result. [Melissa Jackson - OHA / ORELAP] 14:10:31 was not reportable. [Melissa Jackson - OHA / ORELAP] 14:10:39 And I don't know if anybody like Steve or Sarah from the reference lab, if anyone else has any comments on this. Again, we are open to. [Melissa Jackson - OHA / ORELAP] 14:10:48 Um, to suggestions for this section as it is brand new. Go ahead, Chris. [Chris Griffey] 14:10:54 Well, I'm not sure specifically what I would recommend or put forward, but it is as written. It seemed it does seem a little unclear. [Chris Griffey] 14:11:06 Here, and there could be a lot of different room for, uh, different interpretations. [Melissa Jackson - OHA / ORELAP] 14:11:09 Okay, thank you. We'll we'll look into making it more clear. We appreciate everyone's questions and feedback. [Steve Jetter, OHA (he/him)] 14:11:19 Hi, this is Steve Jeter with Orlap. Yeah, I think these are all really good comments. And as Melissa said, this is kind of a sort of a complicated rule to try and write. So any suggestions for. [Steve Jetter, OHA (he/him)] 14:11:35 Wording is always welcome. In order to make this more understandable by everybody. And I think, too, like, to Megan's question, if a result has a clear. [Steve Jetter, OHA (he/him)] 14:11:50 problem associated with it, such as QC that's failing in the batch, or it's over dilution. Those kind of situations aren't really what this rule is intended to apply to. This rule is intended to, um… to apply to when… [Steve Jetter, OHA (he/him)] 14:12:07 There are no other reasons for a reanalysis, but something either doesn't seem right, or you just choose to run all of your. [Steve Jetter, OHA (he/him)] 14:12:17 initial analyses in… in in duplicate or triplicate, or whatever, to determine an average. That's kind of the intent of these rules. So if there's a QC failure or something else. [Steve Jetter, OHA (he/him)] 14:12:32 that these rules aren't really intended to imply to it, and so we probably should make sure that that's clear in the in the wording. [Melissa Jackson - OHA / ORELAP] 14:12:41 Thanks, Steve. Yes, Patrick. [Patrick Trujillo] 14:12:45 Yeah, thank you. I would say I know it comes down. That's probably going to be addressed later, too. But it would be all right to run these multiple or these the reanalyze samples on the same batch, right? If we just re-extracted them twice. [Patrick Trujillo] 14:13:05 or 3 times, or whatever, we could run them on the same batch, right? Because I'm asking, basically, because it comes down to reporting the QC sheets later on, and the… later on in the rules. So I just want a little bit of clarification here. [Melissa Jackson - OHA / ORELAP] 14:13:17 Yeah, if they're all in the same batch, then that you just have to report from that one batch. But if you know, since samples are limited to 20 samples in a batch, there may be times when they might be spread out. And so we're asking if in those cases that all QC would be reported if it was on multiple batches. [Melissa Jackson - OHA / ORELAP] 14:13:45 All right, I do appreciate the feedback on this section. We will work on making this more clear. Go ahead, Chris. [Chris Griffey] 14:13:52 Uh, yeah, I had one more point I wanted to make. It does seem like if you know you're retesting it for the reasons that this section is being added for. [Chris Griffey] 14:14:04 It would be nice to have, uh, some way of. [Chris Griffey] 14:14:08 Let's say you got confirmation all the tests for approximately the same. It'd be nice to have a fallback. You can use the original test as run. [Chris Griffey] 14:14:16 Uh, because putting in… Averages into our limbs is the little… That would require manual steps right now, whereas doing just a straight run can come straight from our limbs. [Melissa Jackson - OHA / ORELAP] 14:14:29 Okay. [Chris Griffey] 14:14:29 Obviously, if there are differences from the first run and the reanalysis, then. [Chris Griffey] 14:14:36 Uh, then that makes a difference. But, you know, if we got confirmation that the original one was just about the same as all the others, and it'd be nice to be able to just report. [Melissa Jackson - OHA / ORELAP] 14:14:45 Okay. And I do know, just for sharing, there are some air methods that require the samples to be run in triplicate and averaged. And so I do know there may be some ways that some limbs can handle this. [Melissa Jackson - OHA / ORELAP] 14:15:00 because we have seen it in some of our other in air in particular. But I think that is a good consideration to take in. [David Standiford (he/him) - OLCC] 14:15:10 I just wanted to speak up from the Olcc side just to a make really clear. This is a May, not a a must or a shall. So not necessarily a requirement. But this kind of is coming from a place of we've had a lot of interest in. [Melissa Jackson - OHA / ORELAP] 14:15:17 Mm-hmm. you know. [David Standiford (he/him) - OLCC] 14:15:30 ways to tackle the concern about a single result being your potency result. And I think a lot of different labs have tried to kind of tackle this in different ways through their own SOPs and their own internal testing process. [David Standiford (he/him) - OLCC] 14:15:45 This is to try and… provide a lot more guidance and clarity, and hopefully kind of loosen up what is allowed here in the sense of that you… it could be run multiple times, and an average taken. And so that… that was kind of the thought taken here, so… [David Standiford (he/him) - OLCC] 14:16:02 Just want to make sure it's clicking with everybody, what we're trying to [Melissa Jackson - OHA / ORELAP] 14:16:07 Thank you, David. [Melissa Jackson - OHA / ORELAP] 14:16:16 All right. Okay, I'm going to move on. But again, if if things come up, or you think of something later, please let us know. [Melissa Jackson - OHA / ORELAP] 14:16:28 Again, just changing shalls to must. [Melissa Jackson - OHA / ORELAP] 14:16:37 changing to the commission seat to sale tracking system to Cts. [Melissa Jackson - OHA / ORELAP] 14:16:45 This next section just adds a little bit of clarity. This is talking about a required limit of quantitation for potency analytes. [Melissa Jackson - OHA / ORELAP] 14:16:57 And in the past it said total Delta 9 LOQ less than or equal to 0.15. We are adding that extra 0 on the end, but you know, LOQs of calculated values can be a little bit unclear, and I think the. [Melissa Jackson - OHA / ORELAP] 14:17:17 what Orlap has been seeing in labs and what we've been telling labs is that this really meant each Delta-9 and THCA needed to be 0.150. So we're just clarifying that here to take away the confusion. And the total Delta-9 needs to stay because. [Melissa Jackson - OHA / ORELAP] 14:17:35 That's written in other rules in other places, but this is what it meant the whole time. And I think this is what. [Melissa Jackson - OHA / ORELAP] 14:17:43 you know, labs have been doing, so hopefully this isn't a big change. You're also welcome to have a lower LOQ. This is the maximum LOQ. [Melissa Jackson - OHA / ORELAP] 14:17:58 Okay, this next one is just another clarification. It hasn't been in the rules before, but when you're performing any calculation, the laboratory must not round values during intermediate steps of the calculation. [Melissa Jackson - OHA / ORELAP] 14:18:14 Uh, rounding may only occur after OWL calculation steps have been completed. Go ahead, Patrick. [Patrick Trujillo] 14:18:22 Uh, yeah, what about truncating value? Just to kind of keep it a little short, you know, we're not being… we're not rounding anything, just kind of truncating that value at, let's say, like, 5 decimal places or something like that. [Melissa Jackson - OHA / ORELAP] 14:18:36 I think that is something to consider, and I think some of the rules that I've seen on the EPA side say to go out to like 6 decimal places. That is something we could consider adding here, because, you know, sometimes these results are going to go out pretty long. [Melissa Jackson - OHA / ORELAP] 14:18:51 Um, so yeah, I do well. That is something we could consider adding here. [Patrick Trujillo] 14:18:56 Okay, I'd welcome that [Melissa Jackson - OHA / ORELAP] 14:18:58 Mm-hmm. So yeah, the EPA for drinking water has specifies these trailing zeros for things like arsenic and PFAS, and they also have the same rule for PFAS, because PFAS also gets added together. [Melissa Jackson - OHA / ORELAP] 14:19:16 It's kind of mimicking those rules there. Okay, um… This next section is kind of long. It's a brand new section. I do want to say it's not something that Orlap just kind of made up. It's actually coming from. So the laboratories are required to follow the 2016 TNI standard. [Melissa Jackson - OHA / ORELAP] 14:19:42 The TNI standard changes from time to time, and it's undergoing a revision right now. And this is a new section in that revision. But we're probably not going to be using that revision for at least a few more years. But we thought what this section said was important. [Melissa Jackson - OHA / ORELAP] 14:19:59 And we wanted to put this in the rules now. Um, so it's mostly from that TNI draft standard, which is linked in the statement of need and fiscal impact with just a few modifications that we made to make it specific to cannabis. And then this is also in the psilocybin section. [Melissa Jackson - OHA / ORELAP] 14:20:18 So a laboratory is prohibited from the following actions during testing, fabricating, falsifying, or misrepresenting data, including but not limited to creating data for analysis that was not performed. [Melissa Jackson - OHA / ORELAP] 14:20:31 unwarranted manipulation of samples or analytical conditions, including unjustified dilution of samples or changing the instrument conditions for sample analysis from the conditions used for standard analysis. [Melissa Jackson - OHA / ORELAP] 14:20:46 Unwarranted manipulation of software, including forcing calibration or QC data to meet acceptance criteria, removing software operational codes, indicating analyst manipulation of results, changing parameters to avoid displaying appropriate qualifiers. [Melissa Jackson - OHA / ORELAP] 14:21:02 Inappropriately subtracting background or improperly manipulating chromatographic baseline. Turning off or otherwise disabling electronic instrument and audit tracking functions. [Melissa Jackson - OHA / ORELAP] 14:21:16 misrepresenting or misreporting quality control samples, including representing spiked samples as being digested or extracted when a digestion or extraction was not performed. [Melissa Jackson - OHA / ORELAP] 14:21:27 substituting previously generated analysis for a non-compliance calibration or quality control analysis. [Melissa Jackson - OHA / ORELAP] 14:21:33 Failing to prepare, analyze method blanks, matrix spikes, laboratory control samples in the same manner that samples are prepared or analyzed. [Melissa Jackson - OHA / ORELAP] 14:21:44 inappropriately preparing or analyzing quality control samples. Deleting or failing to record quality control data outside acceptance criteria to conceal the fact that the calibration or other quality control analysis was outside the acceptance criteria. [Melissa Jackson - OHA / ORELAP] 14:21:59 Performing improper manual integrations, concealing a known analytical or sample problem. [Melissa Jackson - OHA / ORELAP] 14:22:06 Removing failed quality control analysis from the record of an analytical sequence. [Melissa Jackson - OHA / ORELAP] 14:22:11 Excluding known quality control failures from the test report, observing out-of-compliance equipment conditions, then adjusting the equipment into compliance and recording only the compliant observation. [Melissa Jackson - OHA / ORELAP] 14:22:24 Performing repeated or additional testing for the purpose of achieving a preferred result or target potency result. [Melissa Jackson - OHA / ORELAP] 14:22:32 Performing repeated testing or additional testing and reporting the calculated mean results for any testing other than potency and usable marijuana, and performing repeated or additional testing for the purpose of preventing the sample from failing an action limit. [Melissa Jackson - OHA / ORELAP] 14:22:49 in accordance with OAR 333 Division 7. Then it lists. [Melissa Jackson - OHA / ORELAP] 14:22:55 the various sections that that would apply to. So any comments on those? [Melissa Jackson - OHA / ORELAP] 14:23:09 Go ahead, Patrick. [Patrick Trujillo] 14:23:12 I did notice in sub G, small G, it mentions matrix spikes. I mean, it makes sense here, but it's just not mentioned anywhere else. [Melissa Jackson - OHA / ORELAP] 14:23:21 I did notice that as I was reading that, too. It's kind of an optional thing for labs, so we could possibly remove that. [Steve Jetter, OHA (he/him)] 14:23:38 So I'll chime in here. This is Steve with Orlap. I'll chime in here that that that little G. [Steve Jetter, OHA (he/him)] 14:23:45 the… that rule doesn't require the use of matrix spikes, just saying that if they are. [Steve Jetter, OHA (he/him)] 14:23:51 If they are prepared, they must be prepared in the same manner that samples. [Steve Jetter, OHA (he/him)] 14:23:56 prepared and analyzed, um… But it could be clearer, and uh… and we may need to actually look to see if it's defined. [Melissa Jackson - OHA / ORELAP] 14:24:05 Yeah, I don't think we use it anywhere else, really. Yeah. [Melissa Jackson - OHA / ORELAP] 14:24:10 and the matrix spikes don't fail the batch. They're a sample-specific control that helps you determine if there was matrix interference in a sample. [Melissa Jackson - OHA / ORELAP] 14:24:20 Go ahead, Justin. [Justin M.] 14:24:23 I was just curious, and… sections are the small small case P where it says performed repeated testing and additional testing and reporting the calculated mean results for any testing other than potency and usable marijuana. [Justin M.] 14:24:36 But don't we have to report the mean for concentrates, primary and duplicate? So would there need a little more clarification there, or? [Melissa Jackson - OHA / ORELAP] 14:24:37 Yeah. [Melissa Jackson - OHA / ORELAP] 14:24:43 Well, those are technically different samples. This is like on the same sample, so we could add that on the same sample. But yeah. [Justin M.] 14:24:51 Okay, gotcha. [Melissa Jackson - OHA / ORELAP] 14:24:54 But thank you. Yeah, I yeah, that that is. That could be more clear. Thank you. [Melissa Jackson - OHA / ORELAP] 14:25:04 Did you want to go again, Justin, or? [Melissa Jackson - OHA / ORELAP] 14:25:09 Anyone else? [Melissa Jackson - OHA / ORELAP] 14:25:21 All right. Thank you. Appreciate that. [Melissa Jackson - OHA / ORELAP] 14:25:27 Okay. So again, we just have a shall to a must, and that is the end of section of 333-064-100. [Melissa Jackson - OHA / ORELAP] 14:25:37 which is our longest section. So moving along here. [Melissa Jackson - OHA / ORELAP] 14:25:42 Um, we're getting into now 333-064-011 0, which is reporting cannabis test results. [Melissa Jackson - OHA / ORELAP] 14:25:51 We have just some clarification on language. A laboratory must ensure that all test reports clearly just kind of reworded didn't change the the meaning there just made it. [Melissa Jackson - OHA / ORELAP] 14:26:05 rewording clearer. This one here. So it says section D here, identification of the test as a compliance test or a quality control or research and development test. If the test is for compliance and meets Oregon compliance test standards and Division 7. [Melissa Jackson - OHA / ORELAP] 14:26:25 And these rules, the report must on the 1st page state this test report meets Oregon compliance testing standards. [Melissa Jackson - OHA / ORELAP] 14:26:36 And it used to say… it had to say it was an R&D, or quality control report. If it wasn't a compliance test. We're kind of flipping that and now saying, like, if it is compliance, it needs to say it's a compliance using these exact words on the 1st page. [Melissa Jackson - OHA / ORELAP] 14:27:02 Okay. [Melissa Jackson - OHA / ORELAP] 14:27:07 And then this is just a clarification didn't change anything. But if applicable, the test report must state that the test was done on the sample from remediated. That's not. That hasn't changed. [Melissa Jackson - OHA / ORELAP] 14:27:18 Uh, these next ones was one of the things Patrick brought up earlier. So for potency that was tested multiple times on usable marijuana. All test results and batch quality control results must be listed on the report. The reported potency results for each analyte must be the calculated mean of all analysis. [Melissa Jackson - OHA / ORELAP] 14:27:37 So this is saying that if you do choose to run it, run that multiple times, we do want to see every result and the mean and any quality control. So if it was ran on separate batches, you'd have to include all the quality control there. [Melissa Jackson - OHA / ORELAP] 14:27:53 Go ahead, Patrick. [Patrick Trujillo] 14:27:55 Uh, yeah, just touching on this again. I know we have to report the QC samples, but you were saying we have to report all results as well as the means, so essentially like if it were one result and we did the 3, so we'd essentially have 4 reports coming out. [Patrick Trujillo] 14:28:11 One with the average, and then one of each result. [Melissa Jackson - OHA / ORELAP] 14:28:13 This would… it would. It would be on the same report. [Melissa Jackson - OHA / ORELAP] 14:28:17 So it's one report. [Patrick Trujillo] 14:28:18 Okay, yeah, so it's just gonna be… it's just gonna be a massive report. [Melissa Jackson - OHA / ORELAP] 14:28:24 Yeah. [Patrick Trujillo] 14:28:25 Alright, cool. [Melissa Jackson - OHA / ORELAP] 14:28:30 Anyone else? [Melissa Jackson - OHA / ORELAP] 14:28:37 And then this one is saying, if you're doing. [Melissa Jackson - OHA / ORELAP] 14:28:43 testing that requires a primary duplicate or replicate. You need to have the average result of those on the report as well. [Melissa Jackson - OHA / ORELAP] 14:28:52 Um, and not just the individual, so you have to do the math on the report. [Melissa Jackson - OHA / ORELAP] 14:29:00 And I will say for this one here, you know, this really only applies to the 5 accredited analytes. So. [Melissa Jackson - OHA / ORELAP] 14:29:08 I know some labs are running a lot more analyte, so it wouldn't be for anything other than THC, THCA, CBD, CBDA, and delta-8. [Melissa Jackson - OHA / ORELAP] 14:29:17 I don't know if that helps with that report. Go ahead, Chris. [Melissa Jackson - OHA / ORELAP] 14:29:27 Oh, Chris, are you? Go ahead. [Melissa Jackson - OHA / ORELAP] 14:29:40 Can you hear me, Chris? [Chris Griffey] 14:29:51 Can you hear me? Okay, um, for the G section, is that just applicable for potency, or is that? [Melissa Jackson - OHA / ORELAP] 14:29:52 Yeah, I can hear you now. [Chris Griffey] 14:30:01 because it doesn't specify on the G section that for all tests? [Melissa Jackson - OHA / ORELAP] 14:30:05 So it's this is referring to Division 7, and I don't have all of these memorized. But I think it's pretty much any test that requires primary duplicate and replicate, which is mostly potency and solvents, I believe would be the only ones. But someone from OMMP or Olcc can help me out if I'm wrong there. [Margaret Flerchinger] 14:30:30 I believe that is correct for just, um… I think it's just potency and solvents that require. [Margaret Flerchinger] 14:30:36 Rpd, RSD. [Melissa Jackson - OHA / ORELAP] 14:30:48 And so then H says, in addition to the average, it's also going to be the Rpd or RSD as well. So we just want all that information, all that math done on the report. [Chris Griffey] 14:31:03 Uh, sorry, I was having a little technical difficulty, um, can you hear me? [Melissa Jackson - OHA / ORELAP] 14:31:07 Yeah, yeah. [Chris Griffey] 14:31:08 Okay, so that would be for potency and solvents. I heard that part. So that that means we need the average result for the solvents on the report. [Melissa Jackson - OHA / ORELAP] 14:31:20 I'm gonna have to double check that. I… Margaret or David, do you remember? [Melissa Jackson - OHA / ORELAP] 14:31:25 Go ahead, Patrick. [Patrick Trujillo] 14:31:27 As it currently stands, we don't do the average for that, and I think it doesn't require that because it says if required. So that's just my input. [Melissa Jackson - OHA / ORELAP] 14:31:35 Okay. All right. [Margaret Flerchinger] 14:31:40 And I do want to point out there's a typo and a reference to an OER in G. It's the second one. It says 333-007-0140. That should probably be 0410. [Melissa Jackson - OHA / ORELAP] 14:31:55 Thank you. And then, David, do you know if average of solvents is needed? It may not be. [David Standiford (he/him) - OLCC] 14:32:04 No. [Melissa Jackson - OHA / ORELAP] 14:32:05 Okay. Yes. So then this is just for potency. Thank you for that. [Melissa Jackson - OHA / ORELAP] 14:32:15 Okay. Um, and then identification of any failed test on the first page of the test report. Go ahead, Mia. [mia] 14:32:27 Uh, Mia Nelson with Capricorn. Um, I'm not sure what the intent of this is, but my fear is that, um, I don't want any failed test results that eventually are sort of mooted or overruled by later testing to wind up on the front page of the report. And the reason is just that. [mia] 14:32:47 We have found that sometimes dispensaries, you know, kind of alert on, oh, wow, failed test report or failed test symbol, and don't take it any farther, and they just don't want to… they don't want to buy that product. And sometimes there's failures that are remediated or wind up being errors. [mia] 14:33:06 Um, so I would hope that this is only tests that are substantiated to be failed to the point where, like, you know, that matters to this product can't be sold or can't be used for certain things. [David Standiford (he/him) - OLCC] 14:33:20 So in the scenario where products are remediated and or go through reanalysis. There's always going to be a new Coa that's issued, or in rare situations, an amended Coa when there's been some sort of error found. And so I think in all of those. [Melissa Jackson - OHA / ORELAP] 14:33:21 Okay. [David Standiford (he/him) - OLCC] 14:33:38 there wouldn't be the failure. However, the failed test is still tracked in metric and is still required by OHA to be… make sure that other companies are aware that of that testing. [mia] 14:33:44 I know. [mia] 14:33:50 Yeah, I know that, it's just, I, you know, like I said, I don't know what the intent was here, but I just don't want the, like, big failed on prominently on the front page if it turns out that that actually isn't in play for the product being able to be sold. [David Standiford (he/him) - OLCC] 14:34:06 Yeah. The intent is to make it really readable, so that if there is a failure and the product shouldn't be sold, that it's on the first page because we we would hate. We've had companies who've had a failed product and have had a concern, have. [mia] 14:34:16 Right. [David Standiford (he/him) - OLCC] 14:34:24 had, you know, remarked, I didn't know, because it's buried 13 pages back, or something like that, and they just didn't read it, didn't understand it, at least that's what was articulated to us, whether that's true or not, hard to say, but the more readable and clear the COAs are, I think. [mia] 14:34:30 Right. [David Standiford (he/him) - OLCC] 14:34:40 the better it is for business. That's at least our intent. [mia] 14:34:43 Do you that's good to hear. Do you think you could reward this in the rule here to make it clear that it's the only failures that are going to be reported prominently on the front page are the ones that actually are, you know. [mia] 14:34:58 active failures that will impact the legal selling of the product. [David Standiford (he/him) - OLCC] 14:35:02 But that's that is. because this the report issued is for the test results you have. If you get a new test result that shows a pass, you get a new report, and it those the new reports don't show old testing on it. [mia] 14:35:07 Not… not like me. [mia] 14:35:18 I see. So, okay, so that… that will never… that sort of old history that's no longer relevant wouldn't show up on this report? [David Standiford (he/him) - OLCC] 14:35:27 It shouldn't be attached to the new report, because there's been some sort of new testing event, and so that would issue a new certificate of analysis. [mia] 14:35:36 Thank you for that clarification. Makes me feel better. [Melissa Jackson - OHA / ORELAP] 14:35:41 Chris, go ahead. [Chris Griffey] 14:35:43 Uh, yes, this is really more about impact. I only understand the reasoning for this, and you know largely agree with it, but. [Chris Griffey] 14:35:52 Uh, with our current LIMS provider, a complicated change to a C of A might might be at the mercy of their change process. So I'm not sure how quickly that could happen. Something like this. Not even sure if this would qualify for something like that, but. [Chris Griffey] 14:36:07 Just something to be aware of. [Melissa Jackson - OHA / ORELAP] 14:36:09 Okay, thank you. And yeah, this could be something that maybe labs need more time to redesign their reports. [Melissa Jackson - OHA / ORELAP] 14:36:16 And if you do have the time to look into that and provide us feedback over the next couple weeks, that might be helpful as well. [Melissa Jackson - OHA / ORELAP] 14:36:29 Okay. So again, we're still on test reports and things that need to be on them. If applicable for cannabinoid products, the target potency serving sizes and unit of sale, density or mass or volume of intended serving sizes and unit of sale as provided to the laboratory. [Melissa Jackson - OHA / ORELAP] 14:36:47 Yes, Patrick. [Patrick Trujillo] 14:36:50 For the target potency, if it's provided, could it be something as simple as being in the name of the product or something like that, or will it have to be, like, a new field essentially? [Melissa Jackson - OHA / ORELAP] 14:37:02 So it is in Margaret's rules yesterday. It is being added as one of the things I believe that they have to tell you in advance. [Melissa Jackson - OHA / ORELAP] 14:37:12 As far as how that is on the report, I'm not sure if this is. [Melissa Jackson - OHA / ORELAP] 14:37:17 specifically saying, like, where it has to show up. [Melissa Jackson - OHA / ORELAP] 14:37:21 So the lab, we can talk about that or think about that more. It's just saying right here that it has to be on the report. [Patrick Trujillo] 14:37:29 just somewhere. [Melissa Jackson - OHA / ORELAP] 14:37:31 Yeah. [David Standiford (he/him) - OLCC] 14:37:32 One one concern I have with the name approach because I I I don't hate that my my concern is frequently cannabis items have ratios in their name, and only one of those may be a target. [David Standiford (he/him) - OLCC] 14:37:47 and the other one may not. They may not want to set fail criteria for the 4 to 1 for Cbd or something, and they only care about the one part for the THC. And so the name may be unclear to us as regulators of which one had the target. We're both. [David Standiford (he/him) - OLCC] 14:38:04 Targets with fail criteria on the bottom end, like, and that… so that may be… that's why I worry with, uh, just read the name approach. [Patrick Trujillo] 14:38:15 Okay, cool. We'll, uh, try and explore other options. [Melissa Jackson - OHA / ORELAP] 14:38:24 Okay? And then Section K test results and quality control results in a form containing the same or more significant figures as each action level that's defined in Division 7 and and Exhibit C. So Margaret went over those changes yesterday, and then we went over. [Melissa Jackson - OHA / ORELAP] 14:38:43 the changes. It's still only the Lcs and method blank that need to be on the report unless there was a failure for ICV or Ccv. But this is just saying you have to match those significant figures. [Melissa Jackson - OHA / ORELAP] 14:38:59 and then quantitative quality control results and percent recovery. So do it again, doing the math for folks. [Melissa Jackson - OHA / ORELAP] 14:39:15 And yeah, these are some fairly significant changes to the report. So we do recognize it. May January first might be a little too quick for these. So that's feedback we appreciate. We could. We could always kick these deadlines back a little bit. [Melissa Jackson - OHA / ORELAP] 14:39:37 Again, just changing shalls to must. And then here this is a new one as well. The laboratory must have a written procedure for amending test reports when an error is discovered prior to issuing the amended report. The laboratory must supply to the authority or the commission. [Melissa Jackson - OHA / ORELAP] 14:39:55 A letter from the laboratory's technical manager or designee confirming the laboratory mistake or error and agreeing to the invalidation request sample identification date and time of sampling event, date and time of receipt by the lab, date and time of analysis for the samples in question. [Melissa Jackson - OHA / ORELAP] 14:40:12 Complete description of the error alleged to have invalidated results, any observations noted by laboratory personnel when receiving and analyzing samples in question, a corrective action plan that contains a cause analysis of the laboratory accident or error. [Melissa Jackson - OHA / ORELAP] 14:40:28 The corrective actions that will take place, and the dates the problems will be correct corrected, and an amended test report that clearly identifies the report as an amended report on the first page as required in the 2016 TNI standard. [Melissa Jackson - OHA / ORELAP] 14:40:46 So this is basically asking the lab to provide a full description of what happened and kind of a data packet. [Melissa Jackson - OHA / ORELAP] 14:40:53 Um, to the OLCC, or if it's for medical marijuana to the marijuana program. [Melissa Jackson - OHA / ORELAP] 14:40:58 Um, to help them identify what happened and kind of to quick move things along a little quicker. Go ahead, Patrick. [Patrick Trujillo] 14:41:07 And just to clarify, would that be sent to, uh, basically David over at the lab side, or… Okay. [Melissa Jackson - OHA / ORELAP] 14:41:13 Yeah, that has not changed. It it always said to the to either authority for medical marijuana or commission for recreational marijuana. [Patrick Trujillo] 14:41:22 Cool. [Melissa Jackson - OHA / ORELAP] 14:41:23 They… they are free to, you know, consult with the reference lab or or lab. We don't make decisions on that, but we might provide technical consulting on those. [David Standiford (he/him) - OLCC] 14:41:24 Yeah. [Melissa Jackson - OHA / ORELAP] 14:41:34 Justin. [David Standiford (he/him) - OLCC] 14:41:35 Yeah. [Justin M.] 14:41:37 Um, yeah, I'm gonna… I'm presuming this is only the written letter and everything is only if results need to be amended. Say, for instance, we had a clerical error, and we just had to update the sample name or something, we would… this is not applying to that, correct? [Melissa Jackson - OHA / ORELAP] 14:41:52 I think the way that I think… If it's a clerical error. David, I don't know. This is for things that are going to be changing in metric right? The results and metric. [David Standiford (he/him) - OLCC] 14:42:07 Yeah, it may… I guess I'm trying to figure out a good definition of clarity. [David Standiford (he/him) - OLCC] 14:42:14 Because I think I can think of really good examples of one or the other, but where the line is in between them is a little tricky. [David Standiford (he/him) - OLCC] 14:42:24 So… that. [David Standiford (he/him) - OLCC] 14:42:28 Yeah, I think, like, change it… certainly changing a name of a stream is not something I need a data packet for. [David Standiford (he/him) - OLCC] 14:42:37 But, like, we issued a COA that said it failed, and we meant to write pass. [David Standiford (he/him) - OLCC] 14:42:43 While you may have typed the wrong thing, that feels like a much larger… I'm going to have a lot more questions about what happened. [Justin M.] 14:42:55 Yeah, so if for some reason results that have been entered need to be altered, that makes sense. But say, for instance. [Justin M.] 14:43:02 Yeah, like I said, like the name of the sample, we were like, oh, we entered an S instead of a Z, because it was Skittles or something like that, you know, or they noticed that, hey, you were off one digit on the batch metric number. Can you correct that? Would that… those are ones we could just go ahead and. [Justin M.] 14:43:18 reissue without this whole data packet letter. [David Standiford (he/him) - OLCC] 14:43:18 Yeah. [Melissa Jackson - OHA / ORELAP] 14:43:23 Yeah, and maybe we can make that more clear, because I was kind of envisioning this as like when something in metric needs to be changed in order to like. [Melissa Jackson - OHA / ORELAP] 14:43:31 for that part portion of it. Go ahead, Chris. [Chris Griffey] 14:43:36 Yeah, this question is kind of along the same lines, but like a combination of those two instances, one obviously clerical and the other not say, for example, client gives us the wrong unit of sale. [Chris Griffey] 14:43:50 And because of that, we fail at our everything about our report was correct, except for the wrong information given to us by a client. I'm not asking for a resolution of this sort of situation now. Just wanting to bring it up as a possibility. [Melissa Jackson - OHA / ORELAP] 14:44:04 Thanks. Steve. [Steve Jetter, OHA (he/him)] 14:44:08 Thanks. This is Steve Jetter with Orlap. Another point here is, um… that the TNI standard requires any time a lab amends a report in any way, then there are certain processes that need to be followed. And so I think it's going to be important for labs to understand that. [Steve Jetter, OHA (he/him)] 14:44:26 Um, if you're amending a report for a typo, then you have to follow the requirements in the T&I standards, but we need to make it a little bit clearer, I think, in this part, when sort of this data packet. [Steve Jetter, OHA (he/him)] 14:44:41 Is being requested. [David Standiford (he/him) - OLCC] 14:44:45 part of the… part of the reasoning behind some of this is I obviously get these requests a lot, and… frequently, it involves many emails back and forth with the initial reach out being very vague and cryptic from the lab of just, like. [David Standiford (he/him) - OLCC] 14:45:07 something happened, and nothing's clear, there's no, like… like, did, like, could you explain why? Could you, like, what have you guys done to look into this? Like, what… the… and so it invol… it uses a lot of agency time to… to have to kind of investigate what happened, and if. [David Standiford (he/him) - OLCC] 14:45:25 Some of that could be done up front to be more clear to me what has happened, what's going on, what the… what the issue is in a… in a more complete way. I think we could address these much quicker. [Melissa Jackson - OHA / ORELAP] 14:45:45 All right. Thanks for the comments on that. Any anybody else before we move on. [Melissa Jackson - OHA / ORELAP] 14:46:01 Okay, so again, just next one changing commission seed to sale to CDS. [Melissa Jackson - OHA / ORELAP] 14:46:07 These are kind of just adding that 0 to the 100, and then before they said analytical uncertainty. We're just making it clear that meant measurement uncertainty. [Melissa Jackson - OHA / ORELAP] 14:46:17 And then must, shall to must. So that's those are just all editorial changes. There doesn't change the meaning of any of it, really. [Melissa Jackson - OHA / ORELAP] 14:46:30 Um… and that is the end of the reporting section. [Melissa Jackson - OHA / ORELAP] 14:46:37 Any comments before we move on? I believe this next section is the last section for cannabis. [Melissa Jackson - OHA / ORELAP] 14:46:44 will probably take a short break after that and then get into the statement of need for cannabis. [Melissa Jackson - OHA / ORELAP] 14:46:55 Um, and this next section, there's really not a lot of changes. 333-064-0120. This is proficiency testing for laboratories accredited to cannabis. So as I mentioned before, the definition of proficiency testing is changing. [Melissa Jackson - OHA / ORELAP] 14:47:10 But in that definition, it did say Orlap approved. And so Orlap will have those PT providers. [Melissa Jackson - OHA / ORELAP] 14:47:20 be sure that they can still meet the requirements in this section. So I know all the labs are familiar with the method codes and the analyte codes. Those are not going away. Those 17043 PT providers are going to have to submit to us evidence that they can use those, and we've talked to some of them, and they've. [Melissa Jackson - OHA / ORELAP] 14:47:39 told us that they can. So we're gonna set up a… it'll probably be on our website of, like, these are the PT providers that we've approved that are going to use these method codes and analyte codes. So I want to be clear, none of that is changing. [Melissa Jackson - OHA / ORELAP] 14:47:54 And most of the section, pretty much none of this PT section is changing. So still going to have, you know, the PTRL proficiency testing reporting limits, and. [Melissa Jackson - OHA / ORELAP] 14:48:04 still going to require the PT provider to send the reports to us with those Excel spreadsheets. [Melissa Jackson - OHA / ORELAP] 14:48:12 Um, so I don't… I didn't say that before, but I just wanted to make that clear. And so the only section in here that's changing is just a little clarification. There was this was in the section B here incorrectly used to say that with the Pt. [Melissa Jackson - OHA / ORELAP] 14:48:27 You had to submit your ORLAP ID, but that was actually not correct. The number that the labs are using is actually an EPA ID that's listed in ORLAP data input and edit database. [Melissa Jackson - OHA / ORELAP] 14:48:41 all the labs are using the EPA ID. Again, it's an ORLAP-assigned EPA ID for most labs, but that's just to make it clear, because there is a separate ORLAP ID, but that's not what we're using. So that's been in there for a while, incorrect. [Melissa Jackson - OHA / ORELAP] 14:48:56 And we're correcting that. But yeah, so nothing else in here is really changing during the last rule change in 2024, we made some fairly big changes to this section. We're not making changes again, so things will be consistent again, not getting rid of that in in State usable marijuana. [Melissa Jackson - OHA / ORELAP] 14:49:17 Um, for pesticides, mycotoxins, and potency, um, just getting rid of that date here, uh, because we're now in 2026, so we can get rid of that 2024 date. [Melissa Jackson - OHA / ORELAP] 14:49:30 Again, everything staying the same with Pts, except for that we'll have hopefully some more PT providers, but they will have to be approved by Orlap. Same things with the 7 months, 7 days. None of that is changing. [Melissa Jackson - OHA / ORELAP] 14:49:46 Okay. And that is it for cannabis. We got to the end of the cannabis section. So thank you, everyone. Any last minute calls for. [Melissa Jackson - OHA / ORELAP] 14:49:58 comments on that before we take a break and then get into the statement of need and fiscal impact? [Melissa Jackson - OHA / ORELAP] 14:50:08 Okay, well, I really appreciate everyone's participation today. Let's take a 10 min break and come back at 3 o'clock. And we'll get into the statement of need and fiscal impact. So… [Melissa Jackson - OHA / ORELAP] 15:00:47 All right. Hello, everyone. It's a little after it's 3 o'clock. Exactly. We'll give folks maybe a minute or 2 before we dive back into this. [Melissa Jackson - OHA / ORELAP] 15:01:24 Okay. Yeah, thanks for coming back, and thanks for all the work we've done today. I know this is a long meeting. [Melissa Jackson - OHA / ORELAP] 15:01:32 And after this portion, the the meeting is going to switch to psilocybin. So. [Melissa Jackson - OHA / ORELAP] 15:01:38 Some of you may not be as interested in that section. You're welcome to stay. But of course, I understand if you want to go for that section as well. So we're going to do cannabis. [Melissa Jackson - OHA / ORELAP] 15:01:50 We then go back to the rules for psilocybin and then come back to the statement of need and fiscal impact for psilocybin. Hopefully get through it all today, but if not, we'll have to finish up on Friday. [Melissa Jackson - OHA / ORELAP] 15:02:05 All right. Before I get started, I'm just going to make a little statement about what the statement of need and fiscal impact is. [Melissa Jackson - OHA / ORELAP] 15:02:13 So the rules advisory committee must provide recommendations on fiscal impact statements, including advice on mitigating the cost of compliance for small businesses and provide recommendations on the racial equity statement. [Melissa Jackson - OHA / ORELAP] 15:02:28 Including recommendations related to reducing the impact on affected communities. [Melissa Jackson - OHA / ORELAP] 15:02:34 Recommendations for the timeframe of implementation should also be provided. [Melissa Jackson - OHA / ORELAP] 15:02:39 For the racial equity impact statement, we need to consider which populations are affected or most harmed from a racial equity perspective, and what specific ways are specific communities affected by this rule? Communities could include people who receive agency services. [Melissa Jackson - OHA / ORELAP] 15:02:57 Communities, partners, providers, and other interested parties, people from a range of racial, ethnic, cultures, and linguistic backgrounds, people of varying genders, gender identities, and sexual orientations. [Melissa Jackson - OHA / ORELAP] 15:03:11 People with disabilities, people of varying social classes, people representing different geographic areas of Oregon, people of multiple generations, people representing small business interests. [Melissa Jackson - OHA / ORELAP] 15:03:25 So that's what we're going to go over today. And we welcome all feedback on this. It's important part of the process. [Melissa Jackson - OHA / ORELAP] 15:03:32 If you do have additional comments on the statement of need and fiscal impact or racial equity statements. Please send them to either myself or Margaret by August 31st. [Melissa Jackson - OHA / ORELAP] 15:03:46 As a reminder, public comment will open after the rules are filed and will be announced on the program's websites for both Orlap and OMMP. Again, the Orlap website is healthoregan.org/ORLAP, which is O-R-E-L-A-P. [Melissa Jackson - OHA / ORELAP] 15:04:04 Um, that will be the time to submit written comment to the agency, or if you prefer, there will also be a time for verbal comment at a public hearing. [Melissa Jackson - OHA / ORELAP] 15:04:13 Which I believe is scheduled for October 19th. All right. So hopefully everyone is back. And and Margaret started us off on this yesterday. It is the same document that we looked at yesterday. I do believe she had. [Melissa Jackson - OHA / ORELAP] 15:04:29 One change for division seven that she added today. [Melissa Jackson - OHA / ORELAP] 15:04:33 Margaret, do you want to start with that change? [Margaret Flerchinger] 15:04:40 Hi, Melissa. I can do that. Looks like you're almost to that section. [Melissa Jackson - OHA / ORELAP] 15:04:47 But here. [Margaret Flerchinger] 15:04:47 right there. Yeah. And so the language that was added to the statement of need for Division 7 has to do with Section 333-007-0430. It's the standard compliance testing for adult use cannabinoid. [Margaret Flerchinger] 15:05:06 products, or not products, not just cannabinoids, uh, potency, and we're adding in that statement to, um. [Margaret Flerchinger] 15:05:18 clarify the language that was inadvertently removed that said that both the sample the primary and the duplicate have to meet concentration limits. And so we're just adding a… that into the statement of needs a justification, or the need for that rule was not included in the prior version. We reviewed. So that's what's been added here. [Margaret Flerchinger] 15:05:45 I don't think I need to read it. I think everyone can see it on the screen. But if anybody has any questions or comments on it, welcome to state those now. [Steve Jetter, OHA (he/him)] 15:06:09 Hey, Margaret, we didn't actually see the. Were you… were you thinking you were sharing the screen? [Steve Jetter, OHA (he/him)] 15:06:18 Because it wasn't… or… or… [Margaret Flerchinger] 15:06:20 Oh. I think I thought Melissa was, is could I only see Melissa's screen right now? [Steve Jetter, OHA (he/him)] 15:06:25 I'm not… I'm only… I'm not seeing shared screen or other people? [Jesse Sweet, OHA (he/him)] 15:06:31 I can see a shared screen and there's two paragraphs. The first starts with although research and the second starts with adding language. [Steve Jetter, OHA (he/him)] 15:06:40 Okay. Okay. Sorry, I see it now, too. [Melissa Jackson - OHA / ORELAP] 15:06:40 Yeah. Okay. [Margaret Flerchinger] 15:06:41 Okay. Okay, I was worried there for a moment. I was like, how can I only see this? Yeah. So we're talking about the second paragraph that's on the screen that starts with added adding adding language to clarify. So I'll just read it just in case people are not able to see it. [Margaret Flerchinger] 15:06:59 Adding language should clarify that if any individual sample increment exceeds the maximum concentration limits allowed under OLCC rules, the product fails for potency. It's clarifying language has been inadvertently removed, or this clarifying language was inadvertently removed. [Margaret Flerchinger] 15:07:15 During a previous rule change, restoring it adopts or supports public health and safety by ensuring cannabinoid products remain within allowable concentration limits and by confirming that a product fails. [Margaret Flerchinger] 15:07:27 If even one tested sample exceeds the limit. Even when the average of the two samples is within compliance. This update also resolves prior inconsistencies in how laboratories determine concentration limit failures, promoting clarity and more consistency. [Margaret Flerchinger] 15:07:44 For more consistent application of the rule. And I see, Chris, you have your hand raised? [Chris Griffey] 15:07:49 Uh, yes, I just wanted to comment. I appreciate this being added. It felt a little bit like a slight mischaracterization yesterday. You know, for us who work within the rules, if we go looking for guidance in the rules, and we see something missing. [Chris Griffey] 15:08:06 or see something not there. I generally assume that it's a pointed omission, not accidental omission. You know, because we go through things like this rack, and. [Chris Griffey] 15:08:16 And we do a lot of work that… you guys do a lot of work to put the language in these rules, so, you know, when we find something missing, we presume it's on purpose. So, unless we are told otherwise, that's… that's the way we look at it. I… I'm assuming that other people look at it the same way so. [Chris Griffey] 15:08:32 I do appreciate this comment being put in there. Thank you. [Margaret Flerchinger] 15:08:37 Yep, thank you for that. [Melissa Jackson - OHA / ORELAP] 15:08:58 All right. Well, thank you, Margaret. Appreciate that pointing out and adding this here. [Melissa Jackson - OHA / ORELAP] 15:09:08 We'll move on to the Division 64 changes, and. [Melissa Jackson - OHA / ORELAP] 15:09:15 So starting here. So one proposed change broadens the options for proficiency testing to allow the 17 0 4 3 providers who are approved by Orlap. This change hopefully increases Pt provider choice and is equivalent to Pt requirements in other States where cannabis is regulated. [Melissa Jackson - OHA / ORELAP] 15:09:42 Other changes are put in place to improve measurement accuracy and precision of potency and contaminants. [Melissa Jackson - OHA / ORELAP] 15:09:48 This includes updating the definition of homogenization and adding a 1.0 millimeter particle size for homogenized usable marijuana. This change will ensure better sample uniformity for more precise and accurate results. [Melissa Jackson - OHA / ORELAP] 15:10:04 Additionally, the definition and calculation for total potential psilocin will be changed to total psilocybin equivalent. Other changes will be implemented to strengthen analytical method validity and quality control. One of these changes is adding quality control. [Melissa Jackson - OHA / ORELAP] 15:10:19 Acceptance criteria to initial calibration verification and continuing calibration verification to the acceptance limits in Exhibit C, table one under Division 64. And we're also going to be adding this to Exhibit D. Table 1. [Melissa Jackson - OHA / ORELAP] 15:10:35 for psilocybin. Additionally, water activity will be added to the list for quality control limits for ICD and Ccv. [Melissa Jackson - OHA / ORELAP] 15:10:46 That was not in tape exhibit C in the past. [Melissa Jackson - OHA / ORELAP] 15:10:48 Um, another change to improve analytical quality control is placing criteria around the characterization of laboratory control samples for potency testing and adding the the change of adding trailing zeros to limits will be used to ensure significant figures are expressed consistently. [Melissa Jackson - OHA / ORELAP] 15:11:14 Okay. Other proposed changes will will enhance data integrity, transparency, and standardized data handling. These changes include adding a requirement that rounding may only occur at the end of calculations, stating that averaging of results is only allowed for potency and usable marijuana. [Melissa Jackson - OHA / ORELAP] 15:11:34 And setting criteria for that averaging, adding a list of prohibited laboratory activities, adding information that must be listed on test reports and adding steps laboratories must follow if an error is discovered after reporting. [Melissa Jackson - OHA / ORELAP] 15:11:51 That's kind of just a summary of what we talked about today. And then we have a lot of different references here that were used in making these rules. [Melissa Jackson - OHA / ORELAP] 15:12:06 and so here we have the racial equity statement, as I mentioned yesterday. The psilocybin was not part of this. I did add it. [Melissa Jackson - OHA / ORELAP] 15:12:14 And we also heard the comment for addressing the land stewards. I think we need a little more time to work on adding that, so that has not yet been added in here. We're considering how we can add that. [Melissa Jackson - OHA / ORELAP] 15:12:25 But I'll go through it again here for what we have today. [Melissa Jackson - OHA / ORELAP] 15:12:30 The rulemaking is being done in collaboration between medical marijuana program and Oregon Environmental Laboratory Accreditation Program, or ORLAP. [Melissa Jackson - OHA / ORELAP] 15:12:39 Both programs are part of the Oregon Health Authority Public Health Division. This equity impact statement addresses both the testing standards being updated by OMMP and the enhanced operation process for laboratories being implemented by ORLAP. [Melissa Jackson - OHA / ORELAP] 15:12:53 The proposed amendments primarily modernize and clarify cannabis and psilocybin testing rules, and also reduce regulatory barriers and improve consistency in product safety standards. [Melissa Jackson - OHA / ORELAP] 15:13:04 They indirectly advance equity by improving clarity, reducing compliance burdens, strengthen product safety within Oregon's cannabis and psilocybin regulatory system. [Melissa Jackson - OHA / ORELAP] 15:13:17 Clarified testing thresholds for contaminants and potency improve consumer safety and transparency across all communities, while also reducing administrative and financial burdens for smaller businesses. [Melissa Jackson - OHA / ORELAP] 15:13:29 Clear testing thresholds ensure safer and accurately labeled products across all communities, helping to reduce disparities in exposure to unregulated or lower quality cannabis products. [Melissa Jackson - OHA / ORELAP] 15:13:41 These benefits will have a greater impact on vulnerable populations, like those who are enrolled in the medical marijuana program, who use cannabis to help with debilitating health conditions, or those who access services through Oregon psilocybin Services licensed businesses. [Melissa Jackson - OHA / ORELAP] 15:13:59 Any feedback or comments on that? [Siana Ọrun-Walker, I BE I AM INC.] 15:14:05 I don't know how to do the electronic raise of hand. So I I raised my hand at the camera. I was looking in the system the whole time. Okay, so… First, I want to say that I… [Melissa Jackson - OHA / ORELAP] 15:14:08 Oh, go ahead. Yeah. Yes, please. [Melissa Jackson - OHA / ORELAP] 15:14:15 Okay. [Siana Ọrun-Walker, I BE I AM INC.] 15:14:21 Appreciate all of the work that has been going into protecting consumer safety, while also introducing models that I think other states should follow by really seeing what it looks like to. [Siana Ọrun-Walker, I BE I AM INC.] 15:14:37 provide equity for those of us who have been here before the beginning of time. So, something that I wanted to just bring to your attention and my concern today. [Siana Ọrun-Walker, I BE I AM INC.] 15:14:52 is just about, like, unintended consequences. So as an indigenous practitioner, and as someone who works at the intersection of. [Siana Ọrun-Walker, I BE I AM INC.] 15:15:05 Culture or public health, healing systems, there's obviously a lot of rules, right? And the intention of those rules are to protect the consumer. What I find is that there isn't. [Siana Ọrun-Walker, I BE I AM INC.] 15:15:23 how some of these rules lean so much to the analytical side that it makes it hard for those of us who might cultivate our medicine, um, by using marine materials, shell products, um. [Siana Ọrun-Walker, I BE I AM INC.] 15:15:41 Fish products, things that might have mercury in it, right? So if our medicine tests at a higher percentage and we fail when it is our medicine first, this is where the frustration comes up in. [Siana Ọrun-Walker, I BE I AM INC.] 15:15:59 our community. Um, as we sit in these meetings, we have to hear our medicine be talked about as numbers, as letters, and not referred. [Siana Ọrun-Walker, I BE I AM INC.] 15:16:09 to add the indigenous name, right? So for psilocybin, Lucinino Santos. Um, so I wonder what it looks like for Oregon to. [Siana Ọrun-Walker, I BE I AM INC.] 15:16:22 Show other states how to honor indigenous communities by actually seeking. [Siana Ọrun-Walker, I BE I AM INC.] 15:16:30 um, guidance. Uh, and advisory. [Siana Ọrun-Walker, I BE I AM INC.] 15:16:35 from organizations that are directly connected. connected to the leadership of the indigenous tribes in the areas that we're speaking of. [Melissa Jackson - OHA / ORELAP] 15:16:46 Thank you. Yeah, I appreciate that feedback, and I don't think it's a question we can answer right now here in this meeting. But it's definitely welcome feedback and something that I think we can all work on understanding and and and better. [Melissa Jackson - OHA / ORELAP] 15:17:02 better collaborating on this. Appreciate that. Thank you. Yes, Dan. [Daniel Huson] 15:17:12 Just really quick on that, uh, what she was just talking about. I feel if you guys want New Mexico, I feel has done a fairly decent job in writing in things like this. They should be somebody to maybe look towards. [Daniel Huson] 15:17:28 the New Mexico psilocybin program. If you guys need contacts, let me know. I have them all. [Melissa Jackson - OHA / ORELAP] 15:17:34 Okay, thank you. [Melissa Jackson - OHA / ORELAP] 15:17:47 Well, thank you. I appreciate those feedback. and we will take those into consideration and and look into how we can, how we can strengthen this part of our sections. [Melissa Jackson - OHA / ORELAP] 15:18:00 Okay, any other any other comments before we move on? [Melissa Jackson - OHA / ORELAP] 15:18:09 All right. So Margaret went over fiscal impact to division seven yesterday. We'll pick up here for Division 64. [Melissa Jackson - OHA / ORELAP] 15:18:19 So for Division 64, which is for will primarily be experienced by cannabis and psilocybin testing laboratories. [Melissa Jackson - OHA / ORELAP] 15:18:27 Members of the public and other entities may also experience fiscal and economic impact if the cost of items tested by labs increases. [Melissa Jackson - OHA / ORELAP] 15:18:36 In response to the rule changes. Um, specifically going into the details for adding additional ORLAP approved ISO IEC 17043 PT providers, the laboratory chooses to use one of these PT providers, the cost of those Pts may be greater than the cost of current TNI approved PT providers. [Melissa Jackson - OHA / ORELAP] 15:18:56 However, this is an option, so laboratories may still opt to use current TNI-approved PT providers and are not required to use the new options for PTs. [Melissa Jackson - OHA / ORELAP] 15:19:08 A small fiscal impact may be felt by laboratories for the compliance requirement to do a one-time validation of homogenization procedures for usable marijuana, as the laboratories may need to purchase a one millimeter sieve. [Melissa Jackson - OHA / ORELAP] 15:19:21 To perform the validation or purchase additional homogenization equipment to meet the new requirements. Yes, Patrick. [Patrick Trujillo] 15:19:30 I just want to say, just want to say that the fiscal impact for adjusting our homogenization to one millimeter for all things, including stems is probably being a bit understated, because it's not just a one time thing. [Patrick Trujillo] 15:19:45 We do have to validate it, like you're saying, but it's a continual, constant thing that we need to basically ensure this small particle size, regardless if it's one millimeter or 5 millimeters. So just throwing that out there. It's definitely not a small fiscal impact. I would say that's being. [Patrick Trujillo] 15:20:02 massively understated. [Melissa Jackson - OHA / ORELAP] 15:20:04 Okay, thank you. Anyone else? [Melissa Jackson - OHA / ORELAP] 15:20:15 All right. Thank you for that, Patrick. A fiscal impact may be felt by laboratories by adding acceptance criteria for initial calibration verification and continuing calibration verification to test methods. If the laboratories must update their methods to meet the requirements or perform additional calibration. [Melissa Jackson - OHA / ORELAP] 15:20:33 Troubleshooting or testing for analytical batches that do not have acceptable ICV or CCV results. They also may have an increased cost for performing new required steps for characterizing laboratory control samples for potency testing. [Melissa Jackson - OHA / ORELAP] 15:20:57 This part is for psilocybin, but as we already covered the definition, I'll talk about it here now. So there may be some fiscal impact to update their processes for the total potential solution. [Melissa Jackson - OHA / ORELAP] 15:21:13 change to total psilocybin equivalent. We'll go into that more when we get into those rules. [Melissa Jackson - OHA / ORELAP] 15:21:17 Um, adding trailing zeros to the criteria limits, updating test reports. It does sound like we may need to push that deadline back to have labs meet all these requirements. [Melissa Jackson - OHA / ORELAP] 15:21:30 And additional administrative and quality assurance steps to implement if an error is discovered after reporting. Does anyone have anything to add to that? Or again, on the timeline section for any of this? [Melissa Jackson - OHA / ORELAP] 15:21:45 Yeah, it's Patrick. [Patrick Trujillo] 15:21:48 I know, uh, some others from the lab community have expressed need for maybe a little bit longer time. I'm just kind of here to agree with that. I mean, we if need be, we can do it by January first, st but it might be a little bit tight. We could just get a little bit more breathing room. [Patrick Trujillo] 15:22:03 Um, just to ensure that we're in compliance and everything as soon as the rules come about. [Melissa Jackson - OHA / ORELAP] 15:22:09 Okay, yeah, I think we've heard that, and I think that's something we'll we'll definitely consider. And this is specific for the reporting for the test reports. Is that right? Or are there any other things that you're concerned about the January 1st timeline? [Patrick Trujillo] 15:22:23 I think mainly just for reporting, like you're saying, unless anybody has any other things, but from Chem History's end, it's just the reporting. [Melissa Jackson - OHA / ORELAP] 15:22:30 Go ahead, Steve. Thanks, Patrick. [Steve Jetter, OHA (he/him)] 15:22:34 Thanks, Melissa and Patrick. Yeah, I think, you know, in order… As Melissa's mentioned, like, this rulemaking is tied to rulemaking in Oregon psilocybin services, and also with OMMP, and we do need to kind of be conscious of what timeline we're looking at, and so I think in general. [Steve Jetter, OHA (he/him)] 15:22:55 Our goal for these rules to become effective is January 1st, 2027, but for specific components of it, we can put in those, um… the dates when those rules will take effect. So, um, at this point, uh, or here in the, in the fiscal impact statement, if labs can be… labs and other members of the RAC can be specific about the portions of. [Steve Jetter, OHA (he/him)] 15:23:19 The proposed rule changes that they need additional time on, that will be helpful for us to know when to build that in. [Melissa Jackson - OHA / ORELAP] 15:23:32 Thanks, Steve. And yeah, and if you want to put it in writing to us, too, about specific concerns. One thing that came up when we were going through this is for psilocybin, that total potential psilocin is an accredited analyte. So labs will have to update to total psilocybin equivalent. [Melissa Jackson - OHA / ORELAP] 15:23:51 We already have submitted a method code request with TNI lambs. I think we did that about a month ago. We haven't gotten the confirmation for that yet, or sorry, an analyte code. But hopefully that we never really know how long that takes, but hopefully we'll get that soon. [Melissa Jackson - OHA / ORELAP] 15:24:08 So that should be available for labs to apply for soon. But that's another consideration that I haven't heard yet. I know we haven't gotten to that section, but just want to point that out. Go ahead, Jesse. [Jesse Sweet, OHA (he/him)] 15:24:21 Yeah, I realize I'm going out of sequence here, but I just want to bookmark this. Another relatively minor impact which we did reflect on the sniffy that was shared with our rack earlier this summer. [Jesse Sweet, OHA (he/him)] 15:24:39 There's going to be new values on product labels, and that will be an impact for psilocybin manufacturers. [Melissa Jackson - OHA / ORELAP] 15:24:45 Okay. Thank you for bringing that up. [Melissa Jackson - OHA / ORELAP] 15:24:56 Anyone else? Oh, Dan, go ahead. [Daniel Huson] 15:24:59 Uh, yes, please bookmark. I do want to talk about this new accreditation that we're going to have to apply for later. Please, thank you. [Melissa Jackson - OHA / ORELAP] 15:25:06 Yeah, and it's not a new accreditation. It's just adding an analyte, replacing the analytes. [Daniel Huson] 15:25:10 Whoa. [Melissa Jackson - OHA / ORELAP] 15:25:13 So making sure that. Yeah. [Daniel Huson] 15:25:14 Yeah. It comes down to just a math formula, though, basically, right? [Melissa Jackson - OHA / ORELAP] 15:25:19 It does, but that will. We can wait for psilocybin. But this was an accredited analyte. So that's yeah. [Daniel Huson] 15:25:22 All right. Thank you [Melissa Jackson - OHA / ORELAP] 15:25:28 Okay, yeah. Margaret, go ahead. [Margaret Flerchinger] 15:25:34 Yeah, so I just wanted to add one more. [Margaret Flerchinger] 15:25:36 thing to throw out there. When we talk about pushing back timelines for specific sections, for example, like updating test reports, it'd be good to include like what that timeframe is. Are you asking for additional like 3 months? Are you thinking it might take 6 months? [Margaret Flerchinger] 15:25:53 Are you thinking? And I think not just 6 months from, you know, today, but I think an actual date like would March first work for everyone? Is that too soon? So to be specific in a date would be super helpful. Otherwise we're kind of just guessing as to when might be enough, and we don't want to overestimate, because. [Margaret Flerchinger] 15:26:11 We don't want to have to delay these unnecessarily as well. So I don't know if we want to start with a date, if you want to… maybe, Melissa, you have an idea of what something like that could take, and then… If RAC members could respond. [Melissa Jackson - OHA / ORELAP] 15:26:25 Yeah, I think I was thinking March first or June first. I I don't. It's been a while since I was in the lab, and so I'm a little disconnected from how long these changes would take. So I would welcome the feedback from the lab folks. [Melissa Jackson - OHA / ORELAP] 15:26:46 Patrick. [Patrick Trujillo] 15:26:48 Uh, yeah, from our end, I think March 1st is reasonable, um, that should give us plenty of time to roll out different iterations, try a few things out before then. But I can't really speak for any of the other labs. I know we're using different lift systems. [Melissa Jackson - OHA / ORELAP] 15:27:01 Thanks. [Melissa Jackson - OHA / ORELAP] 15:27:07 Dan. [Daniel Huson] 15:27:10 Um, March 1st should be plenty. Uh, we're actually in the process of changing limbs right now, and hopefully, I mean, we should be with our new limbs before January. But yes, March would be great. [Melissa Jackson - OHA / ORELAP] 15:27:23 Okay. Justin. [Justin M.] 15:27:27 Yeah, I would probably second that March seems like it's pretty reasonable on our end as well. [Melissa Jackson - OHA / ORELAP] 15:27:32 Thank you. [Melissa Jackson - OHA / ORELAP] 15:27:37 Thanks for bringing that up, Margaret. Anybody else? [Melissa Jackson - OHA / ORELAP] 15:27:48 Okay, we'll take that March first into consideration for the reporting. It sounds. [Melissa Jackson - OHA / ORELAP] 15:27:54 I don't want to make any promises, but I think it that sounds reasonable to me. So we'll but we'll look into it. Again, I know that. [Melissa Jackson - OHA / ORELAP] 15:28:02 Changing reports can can be time consuming. All right. So yeah, as Margaret said, overall proposed amendments should be relatively low cost, economically efficient and supportive of industry and consumer protection. [Melissa Jackson - OHA / ORELAP] 15:28:18 These changes produce quantifiable cost savings, minimize unnecessary product loss, and strengthen testing accuracy. [Melissa Jackson - OHA / ORELAP] 15:28:25 With minimal regulatory burden. Um… for impact on State agencies. This amendment does not introduce new state level responsibilities, fees or enforcement. I would say, with the exception, and I'll probably add this, that orlap will have to implement that Pt approval process. [Melissa Jackson - OHA / ORELAP] 15:28:48 But besides that, existing compliance and oversight structure are sufficient to implement rule changes. [Melissa Jackson - OHA / ORELAP] 15:28:54 It should result in a negligible fiscal impact on Oregon Health Authority, OLCC, or other state partners. [Melissa Jackson - OHA / ORELAP] 15:29:04 sounds like there might be some minor changes to metric as well that we discovered during this rack. [Melissa Jackson - OHA / ORELAP] 15:29:14 As far as cost of compliance on small businesses. This is the same summary as yesterday. [Melissa Jackson - OHA / ORELAP] 15:29:21 about the number of licensees. [Melissa Jackson - OHA / ORELAP] 15:29:29 And then down here we're talking about, you know, there could be some an administrative activities. [Melissa Jackson - OHA / ORELAP] 15:29:35 Um, for reanalysis, for missing target potency. But yeah, as Margaret said, reduce waste, more reliable labeling, lower risk of market disruptions. [Melissa Jackson - OHA / ORELAP] 15:29:46 Minimal added cost for action limits with trailing 0. [Melissa Jackson - OHA / ORELAP] 15:29:51 And again, as we all talked about, the certificate of analysis updates. [Melissa Jackson - OHA / ORELAP] 15:29:57 we'll have some time. There will be some time put into that by the labs. [Melissa Jackson - OHA / ORELAP] 15:30:07 And then, yeah, so Patrick brought up that laboratories for the homogenization that may incur costs for equipment supplies, labor, or increased administration to be in compliance with the proposed rules for Division 64. [Melissa Jackson - OHA / ORELAP] 15:30:22 Any anything to add here? We're getting pretty close to the end for cannabis section. [Melissa Jackson - OHA / ORELAP] 15:30:35 Okay. So yes, today, again, we we thank you for being part of our rules advisory Committee. This is how we are one of the ways we're involving small businesses in the development of the rules. [Melissa Jackson - OHA / ORELAP] 15:30:46 Um, so we did have… we were thankful to have some OLCC processors, wholesalers, laboratories, members of the Cannabis industry Alliance of Oregon. [Melissa Jackson - OHA / ORELAP] 15:30:56 As well as we invited to Oregon psilocybin services licensees, and thank you for the feedback on that and participation in that, as well as OMMP patients and public members. [Melissa Jackson - OHA / ORELAP] 15:31:10 With that, that kind of concludes what we have for cannabis. [Melissa Jackson - OHA / ORELAP] 15:31:14 And again, you're always welcome to reach out to Margaret or myself if I know sometimes we don't think of things till later. So we'll welcome feedback on that. [Melissa Jackson - OHA / ORELAP] 15:31:23 And again, everyone's welcome to stay, and we welcome your feedback as members of the public for psilocybin services. But we also understand a few. [Melissa Jackson - OHA / ORELAP] 15:31:33 want to sign off here for as we are concluding the cannabis section. [Melissa Jackson - OHA / ORELAP] 15:31:42 So last call for comments on cannabis. [Melissa Jackson - OHA / ORELAP] 15:31:50 Okay. Thank you, everyone. I'm going to get back into Division 64. [Melissa Jackson - OHA / ORELAP] 15:31:59 and this section will be a little bit shorter. There's a lot of the changes are the same as what we just went over. [Melissa Jackson - OHA / ORELAP] 15:32:06 Um, so hopefully… We'll start here with 333-064-0140, psilocybin product sampling procedures and testing. [Melissa Jackson - OHA / ORELAP] 15:32:19 Oh, and I'll I miss changing revision to rev to revision there. We'll change that. [Melissa Jackson - OHA / ORELAP] 15:32:26 But no real changes here for sampling, except for. [Melissa Jackson - OHA / ORELAP] 15:32:32 The must, the shalls to musts. And then same thing for LCS limits. We're changing the it used to say regulated analytes are within the limits. Now it says must be within the limits. [Melissa Jackson - OHA / ORELAP] 15:32:45 And we'll go over Exhibit D, table one here in a moment. [Melissa Jackson - OHA / ORELAP] 15:32:52 Similar to cannabis, we're also adding initial calibration verification and continuing calibration verification. [Melissa Jackson - OHA / ORELAP] 15:33:01 limits to psilocybin, and I'll open up that table now. [Melissa Jackson - OHA / ORELAP] 15:33:14 We have a lot less analytes here, and we did make the ICV, CCV and LCS limits all the same for these for the 4 accredited analytes. [Melissa Jackson - OHA / ORELAP] 15:33:28 With adding those trailing zeros. Any comments on that? [Melissa Jackson - OHA / ORELAP] 15:33:43 Okay, I'm going to go back now. [Melissa Jackson - OHA / ORELAP] 15:33:51 Again, just changing shalls to must. This is we changed to should here to must. So there's no moisture adjusting for psilocybin. [Melissa Jackson - OHA / ORELAP] 15:34:09 And then these are going to be the exact same rules that we had for cannabis about performing calculations, not rounding any values before intermediate steps, rounding may occur only after calculation steps have been completed. [Melissa Jackson - OHA / ORELAP] 15:34:24 And then we went ahead and put the exact same prohibited activities here as well. [Melissa Jackson - OHA / ORELAP] 15:34:30 So again, fabricating, falsifying, misrepresenting data, including creating data for an analysis that was not performed, unwarranted manipulation of samples or analytical conditions, including unjustified dilutions of samples or changing the instrument conditions for sample analysis. [Melissa Jackson - OHA / ORELAP] 15:34:48 From conditions used for standards. unwarranted manipulation of software, including forcing calibration or QC data to meet acceptance criteria, removing software operational codes, indicating analyst manipulation of results, changing parameters to avoid displaying appropriate qualifiers. [Melissa Jackson - OHA / ORELAP] 15:35:08 inappropriately subtracting background or improperly manipulating chromatographic baselines. turning off or otherwise disabling electronic instrument audit tracking functions, misrepresenting or misreporting quality control samples, including representing spiked samples as digested or extracted when a digestion or extraction was not performed. [Melissa Jackson - OHA / ORELAP] 15:35:34 substituting previously generated analysis for a non-compliance calibration or quality control analysis. [Melissa Jackson - OHA / ORELAP] 15:35:40 Failing to prepare or analyze method blanks, matrix bikes, laboratory control samples in the same manner that samples are prepared or analyzed inappropriately preparing and analyzing quality control samples. [Melissa Jackson - OHA / ORELAP] 15:35:54 deleting or failing to record quality control data outside acceptance criteria to conceal the fact that calibration or other quality control analysis or outside acceptance criteria. [Melissa Jackson - OHA / ORELAP] 15:36:06 performing in proper manual integrations, concealing a known analytical or sample problem, removing failed quality control analysis from the record of an analytical sequence. [Melissa Jackson - OHA / ORELAP] 15:36:17 Excluding known quality control failures from a test report, observing out-of-compliance equipment conditions, then adjusting the equipment into compliance and recording only the compliant observation. [Melissa Jackson - OHA / ORELAP] 15:36:30 performing repeated or additional testing for the purpose of achieving a preferred result, performing repeated or additional testing to prevent the sample from failing for an action limit. [Melissa Jackson - OHA / ORELAP] 15:36:43 So the same for cannabis, just made specific for psilocybin. [Melissa Jackson - OHA / ORELAP] 15:36:50 Any comments on that, or anything that anyone wants to add or bring up. [Melissa Jackson - OHA / ORELAP] 15:37:00 Okay. So that is the end of that section. And then we get into reporting psilocybin product test results. [Melissa Jackson - OHA / ORELAP] 15:37:11 Which is 333-064-0150. And again, we just kind of have this section 2 here is being clarified that the laboratory must ensure the test report clearly identifies. [Melissa Jackson - OHA / ORELAP] 15:37:26 Oh, go ahead, Jesse. [Jesse Sweet, OHA (he/him)] 15:37:28 Oh, sorry to interrupt your flow. There's just a minor typo in 2. It should be must ensure that test reports clearly identify. [Melissa Jackson - OHA / ORELAP] 15:37:37 Okay. Thank you. We all fix that. [Melissa Jackson - OHA / ORELAP] 15:37:45 All right. And then there's not as many changes here as there were for cannabis. So again, just a shall to must, and we define the term product tracking system. I'm not sure if that. [Melissa Jackson - OHA / ORELAP] 15:37:59 wasn't defined before, it was just Pts before. and then correcting an amended report. [Melissa Jackson - OHA / ORELAP] 15:38:08 psilocybin services, uh, you're going to. If you want to, if you discover an error that has occurred after reporting a result to the manufacturer or into the product tracking system, the amended report must be generated and communicated to the manufacturer again must enter in. [Melissa Jackson - OHA / ORELAP] 15:38:27 And this was changed from within 48 hours to by basically noon the following day of discovering the error. So that timeline was tightened up a little bit. [Jesse Sweet, OHA (he/him)] 15:38:40 And if I may, that's for consistency with OPS rules. We require all inventory to be reconciled by 1159 the next day. [Melissa Jackson - OHA / ORELAP] 15:38:50 Thank you for that. [Jesse Sweet, OHA (he/him)] 15:38:53 And thank you for the edit. [Melissa Jackson - OHA / ORELAP] 15:39:02 Okay. So this is kind of the big change for psilocybin services. We've already talked about it a little bit. [Melissa Jackson - OHA / ORELAP] 15:39:11 So we're changing from potential psilocin to psilocybin equivalent. [Melissa Jackson - OHA / ORELAP] 15:39:16 Um, the calculation is changing as was also mentioned in the definition section. So psilocyte total psilocybin equivalent will be 1.4 milligrams per gram psilocin. [Melissa Jackson - OHA / ORELAP] 15:39:29 Um, plus milligram per gram psilocybin analyte. And this was done in collaboration with Oregon Psilocybin Services, and there was a work group held on this change earlier this year. [Melissa Jackson - OHA / ORELAP] 15:39:42 Um, so this will change the way that the labs report that. [Melissa Jackson - OHA / ORELAP] 15:39:48 Um… Any comments on that, Dan? This could be the time to bring up the analyte the accreditation for for this. [Daniel Huson] 15:39:58 Sure, I mean. So. Is this gonna require a new on-site and all this other stuff, or is this just basically, okay, you guys did it, and you're. [Melissa Jackson - OHA / ORELAP] 15:40:09 No new on-site. Yeah, just proving you can do the math. [Daniel Huson] 15:40:10 You can do the math. Okay. Okay, all right. That should be not too big of a deal. Then. [Melissa Jackson - OHA / ORELAP] 15:40:16 Yeah. Okay. [Daniel Huson] 15:40:20 However long it takes, it takes, I guess. So yeah, good. [Melissa Jackson - OHA / ORELAP] 15:40:22 Yeah. Go ahead, Steve. [Steve Jetter, OHA (he/him)] 15:40:26 Yeah, this is Steve with Orlap. Thanks, Melissa. Yeah, Dan, so it will. It will require an application to to add the additional analyte, but an on site won't be needed because it's… adding… it's essentially adding an analyte to an existing method for you. [Daniel Huson] 15:40:45 And it's gonna be a wash in my fee, right? Yeah. [Steve Jetter, OHA (he/him)] 15:40:49 Well, there will be a $200 application fee unless you're able to add it during a renewal, in which there won't be any fee. [Steve Jetter, OHA (he/him)] 15:40:58 associated with it. I'd have to look at the timing for renewal. [Daniel Huson] 15:41:05 If we could, I'd like to try to save 200 bucks. [Melissa Jackson - OHA / ORELAP] 15:41:10 Yeah, and we should hopefully be getting that analyte code soon. We can follow up with Tni lambs, but we did submit that, I believe, in July. So that should be available for labs soon. [Melissa Jackson - OHA / ORELAP] 15:41:31 Any other comments on this? [Melissa Jackson - OHA / ORELAP] 15:41:39 Okay, again, just kind of more changing shalls to must here. [Melissa Jackson - OHA / ORELAP] 15:41:45 Um, we do want to see, uh… If there's any analytes associated with quality control results outside of the acceptance limits, then that should be on the report. And this is method blank laboratory control sample ICV and Ccv. And again, this is these are already required in the Tni to have this on the report. In fact. [Melissa Jackson - OHA / ORELAP] 15:42:05 The ICV is failing, the sample should not be reported at all unless there's no more sample left. But if in that case we'd want to see that on the report, and those are already requirements in the TNI standard. [Melissa Jackson - OHA / ORELAP] 15:42:22 And then quantitative quality control results and percent recovery. So matching what's in the chemist and the cannabis side. [Melissa Jackson - OHA / ORELAP] 15:42:35 And then this here is same thing, just adding those trailing zeros, clarifying that analytical uncertainty met analytical measurement uncertainty. [Melissa Jackson - OHA / ORELAP] 15:42:46 And that is, um… That is it. That is all the changes for psilocybin. [Melissa Jackson - OHA / ORELAP] 15:42:54 No. Any questions or any comments before we go back to the statement of need and fiscal impact. [Jesse Sweet, OHA (he/him)] 15:43:04 This is more of a comment than a question, and it's just for. [Jesse Sweet, OHA (he/him)] 15:43:08 the awareness of anyone who might be listening. Ops and Orlap have been working together on this concept. Although we're sequenced slightly differently. Ops has been about a month ahead. We had our racks last month, and I just wanted to let everyone know that revised draft rules. [Jesse Sweet, OHA (he/him)] 15:43:29 On the OPS side will be published for public comment on September 1st. If anyone is interested in in following that. [Melissa Jackson - OHA / ORELAP] 15:43:36 Thank you, Jesse. [Melissa Jackson - OHA / ORELAP] 15:43:46 Okay, well. We'll go back to the statement of need and fiscal impact. I'm not sure I'm going to read back through everything, but I'll just give folks a chance to. [Melissa Jackson - OHA / ORELAP] 15:43:59 um, put their input in specific to psilocybin services, products. [Melissa Jackson - OHA / ORELAP] 15:44:03 Uh, if there's anything anybody wants to add here that we didn't cover already, or that you think is important to be included in this document. [Melissa Jackson - OHA / ORELAP] 15:44:12 We'd appreciate hearing from you now. [Melissa Jackson - OHA / ORELAP] 15:44:30 All right. Well, if there are no further comments, we'll prepare to end the session today. It sounds like we won't need to have the meeting on Friday. So I will cancel those Zoom meeting invites. [Melissa Jackson - OHA / ORELAP] 15:44:41 Again, I really do appreciate the feedback, the participation that we had today. We will take everyone's comments into advice and work on these drafts and publish them when they're ready for public comment, and there will be a public hearing as well in October. [Melissa Jackson - OHA / ORELAP] 15:44:59 And as we've said, you know, if you think of something, please email us, Margaret or myself, by August 31st. That will be the best way for us to potentially take those into consideration for the draft before it goes on to public hearing. But then there is still time for public comment. [Melissa Jackson - OHA / ORELAP] 15:45:18 And yes, I really appreciate everyone's time today, and I appreciate you all being here, being part of this process, and I hope everyone has a great evening. [Alex Marucci - Higher Cultures / Gud Gardens] 15:45:28 Thanks, all. Thank you. [Siana Ọrun-Walker, I BE I AM INC.] 15:45:29 Thank you. Thank you, Melissa. Thank you, everyone. [Melissa Jackson - OHA / ORELAP] 15:45:32 Thank you. [Chris Griffey] 15:45:32 Thank [Daniel Huson] 15:45:32 Thank you.