WSLCB - Work Group - Cannabinoid Science - Public Meeting
(April 6, 2023)

Thursday April 6, 2023 1:00 PM - 2:00 PM Observed
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Established in November 2022, the WSLCB Cannabinoid Science Work Group (WSLCB - Work Group - Cannabinoid Science) was formed to build foundational understanding of the plants of the "genera Cannabis, as well as synthetic equivalents of the substances contained in the plant" as defined in RCW 69.50.204(c)(30).

https://lcb.wa.gov/laws/outreach_and_public_engagement

Observations

Members and agency staff provided praise and criticism of research articles put forward by staff involving “Regulatory Science,” cannabinoid differences, testing results, and terminology.

Here are some observations from the Thursday April 6th Washington State Liquor and Cannabis Board Cannabinoid Science Work Group (WSLCB - Work Group - Cannabinoid Science) Public Meeting.

My top 5 takeaways:

  • Members first had a conversation on "Improving Regulatory Science - A Case Study of the National Ambient Air Quality Standards" noting research hurdles and where regulatory policy and science overlapped.
    • Hoffman introduced the paper and remarked it “highlights the challenge of harmonizing science or scientific advice and policy. And it speaks to the proposition that science can inform but not decide appropriate policy” (audio - 1m, video).
    • West called the 2018 article evidence of “what happens when science and policy go awry,” and explained “from more of an academic standpoint the reason all of this occurs is what's called…an ought to fallacy.” In this instance, “scientists and policy makers kind of confuse what is with what ought to be, and have scientists weigh in on…what ought to be, rather than the what is.” She claimed regulators tended to avoid “policy that is in the name of science.” West believed policy makers tried to be wary when regulations had “a lot of scientific terms, but doesn't really have any scientific backing” (audio - 3m, video).
      • The abstract described how the “paper explores the motivations and institutional incentives of participants involved in the development of regulation aimed at reducing health risks, with a goal of understanding and identifying solutions to what the Bipartisan Policy Center has characterized as ‘a tendency to frame regulatory issues as debates solely about science, regardless of the actual subject in dispute, [that] is at the root of the stalemate and acrimony all too present in the regulatory system today.’ We focus our analysis with a case study of the procedures for developing National Ambient Air Quality Standards under the Clean Air Act, and attempt to identify procedural approaches that bring greater diversity (in data, expertise, experience, and accountability) into the decision process.”
      • West explained that the U.S. Environmental Protection Agency (EPA) had established a “Clean Air Scientific Advisory Committee” with responsibility for “to review the scientific criteria from the EPA regarding these standards and then provide recommendations on the standards.” This had included a “particulate matter threshold for the air quality…and actually those are the standards that we use today,” she noted. However, West said the problem was “there is no evidence that, until you get down to a zero threshold, then you have like no health effects. So, you can't say [a] ten threshold is better than a one threshold when we're trying to do a public health…initiative because…they're all negative health effects.”
      • She commented that policy makers in this instance hadn’t wanted to “go against the scientists because ‘they know what they're doing better than us.’ And so they go with those standards, too…the result is that the standards mean absolutely nothing.”
    • Work group members and agency staff began to weigh in on how science should, or shouldn’t, be used to justify regulatory policies (audio - 15m, video).
      • Hoffman established how the subject related to a collective interest in “scientific expression of processes that might be allowable to create safe products. How we might define regulation when we're thinking about both policy and science.” She then pointed to a “big topic related to this…hemp derived cannabinoids,” and finding common “language that can be informed by science but expressed through policy.”
        • West will be responsible for the implementation rulemaking project for SB 5367, "Concerning the regulation of products containing [tetrahydrocannabinol] THC," which was signed into law on May 9th defined any hemp consumable containing detectable amounts of THC as ‘cannabis products.’ Staff previously indicated the CR-101 would be presented to the board to open rulemaking on June 7th.
      • Douglass felt those in scientific fields “don't often think about such issues and how there's a handshake in some ways between science and policy makers.” He argued “up until recently, scientific advisory boards, work groups such as ourselves were very reluctant to even wade into policy recommendations, and on the flip side policymakers really held advisors and scientists” to an expectation to “help [officials] understand the way things are, but leave the policy making to us.” Douglass saw the interests and input of board members as the “roadmap” towards “a pathway where we can weigh in on what we see this science helps describe and sort of setting the table for policymaking from there.” 
      • Vollendroff emphasized that agency leaders were seeking "good quality information" which could be utilized by agency staff to “make evidence-based policy decisions,” mentioning a new Research Unit at WSLCB. Hoffman commented, “the reason the additional three pieces of work were shared with everyone, [was] so we could have a discussion about how those pieces might inform the work that LCB is doing.” Her request was that attendees “critique some of that work” as staff considered “how [we interpret] that into policy.” Then, Vollendroff brought up how his previous work at UW “disseminating evidence-based practices related to behavioral health” had motivated his interest “to accelerate the time frame in which good evidence-based scientific information and best practices got introduced into public policy, and actually into clinical practice.” He perceived a “big time lag between evidence-based approaches and evidence-based treatment being introduced into clinical practice,” and wanted the work group members to be one way for WSLCB leadership to “accelerate our knowledge about what's happening. Things are happening so quickly and this industry is evolving so rapidly that we can't possibly keep up” without external input, Vollendroff told the group. He felt they could help shorten “the time frame in which we're making good public policy decisions with good scientific information.”
      • A challenge, according to Tonani, was that in cannabis there's "not a lot of translational research" due to federal restrictions on studying cannabis. This meant some researchers were doing “federally illegal work,” while other university research bodies—including WSU CCPRO—were further limited in their activities if their campus received federal funding. In other fields, there would be translational research which connected emerging data to how that might be useful to lawmakers and regulators, so she wanted WSLCB staff to “be cognizant of that and figure out how we fill those gaps.”
      • Gang mentioned a “cannabis conference this summer where we're gonna have a panel over, talk about policy and connections and all this stuff.” He’d found one obstacle was “a lot of times to most scientists they look at what they are doing and to them it seems very objective,” yet “oftentimes it is not actually. There's a lot of subjective biases to what they do, how they view things, how they go about their experiments.” He believed a number of factors particular to individual researchers impacted “the kinds of answers that you can get in response to what you do,” even in setting up an experiment with objective measures.
        • Gang’s opinion was that members of the scientific community often saw others take their data or research conclusions, “and a lot of times they get very frustrated because they see decisions that are made that seem to go very much against what, to them, the science says.” While research bias existed, “another realm which comes into play and that’s the political realm,” he said, arguing that “it's become very clear that…a lot of times politics trumps the science,” which, “from the scientist's perspective is even more frustrating.” Gang thought scientists were like anyone else who thought “about society and they think about what should be happening in society, and they look at what they're doing” in the research they’d conducted, “and then they see what other people are doing with that and it's extremely frustrating that people are just not getting it,” or even misusing, ignoring, or favoring “data that's not correct.” 
        • Despite this pattern, “gravity is gravity; it's going to pull you to the ground if you jump out of an airplane, you're not going to be able to fight that, so there's all these things that eventually the science will actually win out." Gang stated scientists should focus on helping officials “make the best decisions that are going to be for the best of society, and…make that information available” and communicate it to the public.
        • There were several cannabis-focused conferences announced for 2023 and early 2024, including a Cannabis Regulators Association (CANNRA), “external stakeholder meeting that takes place in the summer.” In 2022, the event was hosted in Seattle with limited public engagement.
      • Hoffman welcomed critical analysis by members of how to close the research gaps in "scientific expression and regulatory expression." 
      • Moody highlighted how the National Institute of Justice (NIJ) had called for “improvement” in some areas of forensic science in 2022, and suggested “​​they were sort of pseudoscientific, like handwriting analysis or blood splatter analysis.” He wanted cannabis policy makers and scientists to “watch out for things that may look scientific as you're saying, but they're not.” Moody cautioned it would be “difficult without funding to look into areas” and determine the reliability of emerging studies, but “otherwise we'll be chasing down rabbit holes for the policy makers and for the scientists.”
      • Poolman perceived a “Venn diagram” of overlap between policy and science, “but not a great one." He argued the definitions in the Uniform Controlled Substances Act were scientific, yet “there's a lot of numbers in there for chemical names that any layperson reads and is just put off by immediately.” He hoped to find more “common words or names that bridge science to policy or at least make science more ingestible for policy.” Hoffman concluded that it could be “hard to put all those numbers and letters and chemical compositions in a statute.”
  • Next, they critiqued a study by Nephi Stella, University of Washington Center for Cannabis Research (UW CCR) Director, on "THC and CBD: Similarities and Differences Between Siblings."
    • Hoffman moved their “critical eye” to Stella’s 2023 research paper on THC and CBD, and asked for their “thoughts about this…could this article potentially inform policy makers?: What words still needed a “segue…to connect into policy?” (audio - 1m, video)
      • The abstract summarized how the “sibling” compounds THC and CBD, “are produced by the same Cannabis plant and have similar chemical structures but differ dramatically in their mechanisms of action and effects on brain functions. Both THC and CBD exhibit promising therapeutic properties; however, impairments and increased incidence of mental health diseases are associated with acute and chronic THC use, respectively, and significant side effects are associated with chronic use of high-dose CBD. This review covers recent molecular and preclinical discoveries concerning the distinct mechanisms of action and bioactivities of THC and CBD and their impact on human behavior and diseases. These discoveries provide a foundation for the development of cannabinoid-based therapeutics for multiple devastating diseases and to assure their safe use in the growing legal market of Cannabis-based products.”
      • Stella finalized the report while he was a member of the Washington State Hemp in Food Task Force without disclosing his work on the report to other members, several of whom were in the work group. He stopped attending meetings after December 2022, as he was the holdout on consensus over the group recommending a THC limit for hemp cannabinoids.
    • Tonani stated that Stella provided a suitable “overview of…the topic in general. I would say that there's some pretty significant typos in there,” involving the “total milligrams versus milligram per kilogram, that could have some pretty significant impacts on policies.” She said groups like “journal clubs" could aid in reviewing studies, in case “something occur[ed] that could really impact long-term policy” (audio - 11m, video).
      • Gang asserted the “numbers that are called out…lead to an obvious conclusion that is made in the review, but those numbers are not actually correct,” remembering an instance where the report was “citing another paper incorrectly.” He was further skeptical the “methodology that was used is accurate…with our current technology we’d say ‘probably not’.” But that might evade anyone “who…doesn't take that citation list of the end of the paper and go dig up all of those papers and read them carefully” to ensure there weren’t “different values” in units. Gang argued units of measurement and cited numbers had been “all over the place in the literature, and trying to go through and do that analysis and get those numbers right [was] very challenging,” especially as Stella had been “sole author” of the report. Additionally, “review articles [were] not reviewed necessarily to the same standard, in fact, they usually are not reviewed to the same standard as a scientific data paper,” and Gang felt “editors” reviewed Stella’s work without spotting “anything obvious as problems, and they don't dig into it as deeply as they could and I think that's pretty clear from this paper that's what probably happened.”
      • McLay also felt there were issues with the study, but “overall as…a foundational paper for someone that's new to the topic. I think it hits a lot of points that are relevant and can teach somebody very quickly…what these two compounds can possibly do, how they work in the body.” “Without the specifics” of Stella’s conclusions, McLay argued the paper could serve as “a good foundational paper.”
      • Douglass considered the paper was direct in calling out how “pharmacology is complex and cannabinoid pharmacology is extraordinarily complex, and that we need to be cautious about making inferences from receptor biology and reductive aspects of cannabinoid pharmacology for high level human effects.”
      • For Carter, who worked “directly with receptors in cannabinoids and endocannabinoids,” the study had missed some more “current literature.” He was interested from “a physiological standpoint where I study in the immune system and immune development,” finding Stella’s work “very skewed towards the brain.” Carter remarked he’d “just got back from [the] Society of Toxicology meeting, and some FDA scientists that work on CBD and THC” related to “hepatotoxicity development” were often giving “massive doses of things to try to find an issue so they can stick on it.” He argued, “there's so much literature on cannabinoids that there's a big gap in the years when the endocannabinoid system wasn't developed or defined. We're now finding and pick and choosing” whether receptors in the body were part of it. Carter suggested a significant “gap in where a lot of these effects are occurring.”
      • Murray advised against focusing on specific numbers because of the “extremely complex pharmacology as we were talking about receptors,” and instead they should “look more at the pharmacokinetics of what's happening with our clients or our patients who are going to be using these products in our general society.” Her opinion on research was that it “show[ed] us that we can't really put numbers” to how much “delta-8[-THC] is going to be okay for people or not because we just don't have the literature out there.” Murray felt that qualitative studies were preferable, “which maybe is a lower level of evidence, but case studies or other cohort type studies may help here to…show in a larger cohort like how this is actually functioning for our greater population.”
      • Moody called for a “common testing framework” to help standardize the “common terms” so there was less room for confusion, or data being “skewed.”
  • A discussion on "The Dark Side of Cannabidiol: The Unanticipated Social and Clinical Implications of Synthetic [Delta-8] THC" had members thinking about how to better educate consumers.
    • Hoffman encouraged the conversation move on to the next paper, where the abstract laid out the study design and findings (audio - <1m, video):
      • Introduction: The explosive growth of the cannabis industry in the United States over the past decade has spurred a multitude of products derived from phytocannabinoids produced by Cannabis sativa L. Decades of cannabis prohibition coupled with the more recent 2018 Farm Bill have lead to several unanticipated consequences and the widespread availability of synthetic cannabinoids derived from hemp CBD, including D8 -THC, D[elta-10]-THC and HHC [hexahydrocannabinol]. 
      • Methods: Herein, we review the available literature of the complexity of the chemistry of its current manufacture, namely, the acid-catalyzed ring closure of cannabidiol (ACRCC), the myriad of issues involving the unsolved technical problems with quality control of ACRCC-D8 -THC and the multitude of isomerized byproducts, and the lack of consistent regulation regarding consumer safety and labeling. 
      • Results: We provide what we believe is the first comprehensive listing of all the documented ACRCC-D8 -THC byproducts. Perhaps, most importantly, we highlight the growing concern that, other than D8 -THC itself, the compounds in ACRCC-D8 -THC product mixtures have not been subjected to any human toxicological evaluation. This is especially troubling as ACRCC-D8 -THC products relate to vaping, and their contribution to a growing and lethal epidemic of electronic cigarette, or vaping, product use–associated lung injury (EVALI). 
      • Conclusions: Quality control is totally inadequate in the newly emerging D8 -THC industry. American consumers are ingesting products that are mislabeled with many compounds that have never received any toxicological testing. EVALI cases continue to be reported with a fatality rate approaching 2% (in California).
    • McLay began the discussion with an observation that “we don't have a lot of…testing available for commercially available products” and that there would be better research once testing practices improved. “Even what’s being added into the products has been an issue” where he was based in Pennsylvania. McLay stated, “We had some delta 8 gummies pulled off the shelves for fear of fentanyl being injected in them and they don't know at what point it may have happened and then the district attorney took back that statement.” He considered delta-8-THC items to be viewed by the public with “a lot of discomfort and a lot of mistrust, and it may be rightfully so. But I'm not sure what we can do to control what is out there.” He felt mandatory testing should be “at the top of the list” (audio - 6m, video).
      • Murray echoed his point, remarking that cannabis labeling in Washington had “lots of percentages" so people got “this general idea of what you want.” However, "none of that really makes sense" and you can end up with a product that doesn't address your needs, particularly for patients using cannabis as medicine. 
      • Tonani offered that many consumers “don't know what they're purchasing” and chalked some of that unfamiliarity up to the fact that labeling laws were set “ten years ago” in Washington. Other states had “been much more progressive on medical reporting out for patients.” While Washington “had to be really conservative because we were the first state out there” with legal cannabis, she argued the work group could contribute to helping “modernize the rules around that and some of the, the information.”
      • Wise shared an article her colleague had written on problems with THC labeling, emphasizing that “it would be really helpful to have…standard units that we all talk about” as that had been a drawback of Stella’s paper. She believed, “we might consider having [a] standardized one unit kind of way to talk about these types of things” to the benefit of regulators and consumers. Hoffman recognized how one of the identified interests of work group members had been educational information for the public. She found this was a “common theme…and when we talk about testing, what kind of language can we come up with that…is testing more in layman's terms.”
  • "Delta-8-THC and Its Derivatives: A Synopsis of Recent Lab Findings" was the final paper that work group members looked at, raising a couple of questions before the meeting wrapped.
    • Hoffman called out the presentation of the paper as being “easier for me to digest” compared to Stella’s research, arguing that regulators were routinely “really pressed for time” so any paper which “summarizes the high level pieces” was useful for staff who would have to “translate that into something that we write into a rule” (audio - 2m, video).
    • Next, Hoffman encouraged “throwing out some words related to standard units" with the following units mentioned (audio - 4m, video):
      • Milligrams (mg) was the most frequently cited unit of measurement.
      • Parts per million (ppm)
      • “Microgram per milligram or gram”
      • Percentage of THC
        • McLaughlin noted that Canadian authorities had eschewed percentages in favor of strictly stating THC mg in any cannabis product. Tonani and McLaughlin thought route of ingestion mattered as well: “10mg of edible THC is very different from 10mg vaped.”
    • Testing terminology was the final question from Hoffman, who wondered about terms “that the public generally might not understand that we could translate” (audio - 2m, video).
      • Wise said “‘uncertainty,’ ‘total cannabinoids,’ ‘total THC’” were terms causing confusion, as was ‘potency,’ which she described as “completely incorrect and I try to never use it.” Sams and McLaughlin fully agreed, with McLaughlin calling out percentages of THC-O-acetate being even more confusing for consumers. Tonani mentioned labeling of ratios of THC and CBD to be “confusing to some.”
    • Hoffman thanked participants for the conversation, encouraging them to continue sharing thoughts on the matter via email “in between meetings.” She promised to share minutes and continue honing in on the best language for WSLCB staff to use “to inform consumers in the marketplace and decision makers” (audio - 2m, video).
    • Nordhorn lauded everyone who had been involved, telling the group this dialogue was “critical” and they were helping regulators set the best possible policies (audio - 1m, video).
    • The next work group meeting was set for June 1st. The agenda indicated members would address environmental pesticide actions and discussions on:
      • A “way we could look at cannabis product classes (flower, edibles, distillate) versus a single crop since safety around consumption method could be very different?”
      • “How does the level of a contaminant in the soil effect floral contaminant levels?” 
      • “Insights around the definition of cannabis product and ‘any detectable amount of THC’” at issue in the implementation of SB 5367.

Engagement Options

Livestream

https://teams.microsoft.com/...2%3a%226b1fbcfc-15e4-4227-b216-3591da1980cc%22%7d

Meeting ID: 253 504 475 688
Passcode: kV5qxV

Phone

Number: +1 564-999-2000
Conference ID: 346 058 9#

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