WSLCB - Deliberative Dialogue - Cannabis Impairment
(June 21, 2022)

Tuesday June 21, 2022 1:30 PM - 3:00 PM Observed
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Deliberative Dialogue is a method to facilitate participant engagement in policy discussion that can be adapted to a variety of issues and to both stakeholder and citizen processes. "Dialogue" is about creating meaning together, finding a shared understanding of an issue, and discovering what values are most important in resolving it. Dialogue is often open-ended, focused more on increasing understanding and developing relationships than on reaching an agreement. "Deliberation," on the other hand, emphasizes the importance of examining options and trade-offs so people can make informed public decisions.

Invitation to Continued Discussion on Evaluating THC compounds: What is and is not “impairing”?

June 21 session continues focus on Delta 8 and other unregulated cannabinoids

The public and the cannabis industry are invited to a June 21, 2022 discussion to help shape future policy and rules related to how LCB and state law will define what are “impairing” and “non-impairing” THC compounds and cannabinoids.

Background: Since early 2021, new unregulated cannabinoid products that may be “impairing” (other than delta-9 THC) began being sold online and in stores across the nation. This raised questions nationwide about the legality and possible health impacts of these new products, being sold without age-restriction or regulation. A year ago, the LCB Board issued Policy Statement Number PS-21-01 about THC compounds. In January 2022, the Board adopted a new rule section, WAC 314-55-560 that allows the Board to evaluate additives, solvents, ingredients or compounds used in the production of cannabis products.

During the 2022 legislative session, bills introduced to address concerns about the regulation of these emerging products did not advance to passage. The LCB continues to gather information to inform future policy and rule development within the agency’s current statutory authority.

from the event announcement (June 7, 2022)

Panelists

Observations

Panelists with experience in drug prevention and behavioral science couldn’t reach consensus on the question of what makes cannabinoids impairing during a final dialogue on the topic.

Here are some observations from the Tuesday June 21st Washington State Liquor and Cannabis Board (WSLCB) Deliberative Dialogue on Cannabis Impairment.

My top 4 takeaways:

  • A series of prepared questions for the panel covered the definition of impairing, Oregon cannabinoid regulations, proof of safety, impaired driving, and other regulatory implications.
    • Policy and Rules Manager Kathy Hoffman asked the defining question: “from your perspectives…how might we determine and define what is, and is not, impairing?” (audio - 9m, video)
      • Carlini preferred to stay clear of the term “impairing” and to look at risks of a compound’s use as “you may be impaired, but not at risk. And you may be at risk, and not impaired. And I think the focus should be the risk of experiencing harm” in the near or longer terms. In someone’s home, taking a substance could impact their "capacity of judging reality" and they’d be “under the influence” of a drug, she commented, but that private activity wasn’t what the WSLCB was trying to regulate. Carlini instead wanted to keep focusing on contexts where substance use was risky, like long-term use or impairment while operating a vehicle.
      • Looking at risks made Freng think of the “primary focuses for the prevention community” which was concerned with “youthful use of basically any psychoactive substance.” In his estimation, policy makers would do well to consider if “all THC-based products should come under the same umbrella" of regulations, as focusing on impairment could “conceivably be seen as a red herring given the depth and complexity of the issues.” Freng believed any THC item was “psychoactive, they affect cognition, affect memory, perception, and orientation” and he didn’t see differences between the risks for delta-9-THC items and other “THC products,” particularly in regard “to children and youth.”
      • Schauer spoke to approaches taken in other states “and where are the gaps” in policymaking, saying other jurisdictions often expanded definitions of THC or cannabinoids but this process tended to necessitate keeping “up with innovation and the industry” by continually amending statutes with new cannabinoids “as they came into the fold.” A different approach had been taken in Oregon, where she said officials gave broad authority to regulators at OLCC over “any artificially-derived cannabinoid that’s reasonably determined to have an intoxicating effect.” Schauer then mentioned New York and Michigan as states where elected leaders put hemp and cannabis products under the same regulatory “umbrella.” She contrasted this with places where cannabinoid products fell under the authority of many agencies and “there are still gaps in what’s under the umbrella.” A single authority over hemp and cannabis items, “in theory, can allow the regulator to not maybe have to focus on impairing” and instead just oversaw consumer safety for all “end use” cannabinoid products, Schauer told attendees
    • Freng wondered if Oregon officials were “indeed banning…synthetic cannabinoids as of July 1st” (audio - 2m, video).
      • Schauer replied that all cannabis and hemp products had been moved under the authority of OLCC where staff would determine if there was “a safe way of manufacturing” a product for that state’s medical or adult-use market. She acknowledged there were states that had banned delta-8-tetrahydrocannabinol (delta-8-THC) but "we don't have good science" for whether cannabinoids like that were impairing yet. Schauer argued that when a jurisdiction “outright ban[s] something….you have to see what happens on the illicit market," so putting items under the purview of an adult-use market regulator had been considered preferable.
    • Next, Hoffman inquired about task forces being set up by states to study cannabinoid regulation. She mentioned a Colorado task force looking at “what is and isn’t intoxicating” in order to patch “the holes in the umbrella” (audio - 12m, video).
    • Hoffman asked Carlini about the state’s role in product manufacturing, and what burden should “be on the manufacturer, not the state,” to establish product safety (audio - 7m, video).
      • “We all strive to have responsible industries and…a responsible society,” said Carlini, comparing cannabinoid products to automobile tires which came with a lot of rules “to be able to sell.” Though “complicated,” she reasoned that a similar standard could be applied to cannabinoid items, repeating her call for having "the industry actually pausing a little bit and bringing to us" certainty of product safety. Carlini appreciated this could have “implications” for businesses, but “I feel like we are being cornered" into producing safety standards for items not well understood.
      • In Schauer’s estimation, another challenge to enacting legislation in this sphere was how “technical” the subject matter was for legislators always dealing with a variety of policy issues during a session. Moreover, “there are some different priorities that different stakeholder groups bring to the table” which she felt a task force might be able to address. Her sense was that “the industry is a bit torn on this" as some hemp products create “some threat" to adult-use cannabis markets because barriers to entry were “far lower” and lacked testing and labeling compliance rules. Schauer commented that stakeholders of all kinds wanted “predictability” in the cannabis space, including public health and prevention sector interests who were “very concerned” about youth access to hemp-derived cannabinoids. She mentioned a study conducted in California where retailers had “100% compliance” in checking customer identification (ID), suggesting stores themselves weren’t youth access points for cannabis. Consumers deserved reliable products “whether they’re impairing or not,” and regulators deserved authority and staffing to effectively oversee cannabinoid markets, leading Schauer to think "we need to do some work" on stakeholder priorities to “understand where those overlap.”
      • Freng concurred with the comments on youth use, observing he was "curious about why we are so fixated on production as opposed to the product" pointing out how “strident as we are in regards to…how it’s derived.” He preferred to focus on the risks from use of the end product, particularly for “different groups and demographics.”
    • Asking Freng to build on his earlier analogy about regulating various types of opioids, Hoffman understood he meant it as a “simplification,” but was interested in knowing more about how that resulted in end product regulation (audio - 3m, video).
      • Freng established that opiates and some opioids were derived from poppies, but as that "piece of biochemistry became more mature" semi-synthetic and fully synthetic opioids like fentanyl were “all regulated in the same manner” even as their “psychoactive properties” differed. This made for more “coherent” regulation as the varying opioids had “more similarities than differences."
      • Schauer mentioned that there was a “range of things” regulated federally that similarly had different product types and thresholds for consumer or medical products. However, a “patchwork” legal status of regulation between states, and even within states between cannabis and hemp markets, was a serious challenge to consistent regulation, consumer safety, and eventual national standardization in those markets.
    • Hoffman invited additional comments from panelists on defining impairing (audio - 5m, video).
      • Freng shared his perspective that the definition for impairment was only “operationalized when it comes to driving motor vehicles” and “otherwise it seems to be an incredibly fuzzy and difficult target to hit.” Under the impression that Washington State Patrol (WSP) troopers had "a rather clear idea" how to determine whether "someone is under the influence, as opposed to impaired,” he said there were “broader considerations” for policy makers than a “consensus” definition for impairment.
      • Schauer pointed out that Washington was among many states that adopted a standard of five nanograms (ng) per milliliter of THC in the bloodstream, but “even that has come under question because we don’t have good science” on whom that level would be considered impairing especially as “we know that it differs by population.” She added this was why law enforcement in many states still relied on drug recognition experts (DRE) and the Advanced Roadside Impaired Driving Enforcement (ARIDE) standard taught by the Washington State Criminal Justice Training Commission. However, this was still a subjective assessment, not objective science, noted Schauer.
      • Carlini concluded that impairment as a concept “could almost bear into…almost a moral topic” about private behavior so she chose to focus on “protecting people from harms” of substance use.
      • Freng called out hallucinogens as “another family of drugs” with differing properties that could be naturally derived or synthetically created but were all “regulated as a single entity” - by being federally prohibited.
    • Director of Policy and External Affairs Justin Nordhorn endeavored to drill down to what kind, or at what THC level, products needed to be regulated (audio - 6m, video).
      • Personally, Schauer thought "any product coming from cannabis should have some regulation for consumer safety.” She added that hemp products, regardless of whether they were considered impairing, needed to meet “a basic threshold” of testing, packaging, and labeling, as well as submit to a “higher risk pathway" similar to what officials in Oregon had defined. By way of contrast, she noted that Minnesota lawmakers set “a serving size of five miligrams of THC” or “50 milligrams in a package” and that the items would be available outside of the state’s medical cannabis market.
      • There remained a “deficit in regards to research" on cannabis impairment, Freng remarked, whereas blood alcohol content (BAC) levels generally correlated to impairment except for those with “an unusually bizarre clinical tolerance.” He thought 5ng had been adopted into Washington law “‘cause Colorado did that” but that amount might be “relatively arbitrary” as it “isn't based on solid long-term science."
      • Carlini knew there was “a lot of damage from alcohol in society” leading to alcohol prohibition which she considered a policy “failure” that led to crime and “injustice.” This gave alcohol a “century plus of knowledge built both on trial and error” of regulatory systems and research, she argued. Whereas with cannabis, society was "paying the big huge price" from a prohibition inclusive of a ban on cannabis research. As compounds like THC-O Acetate and hexahydrocannabinol (HHC) had “literally never been studied in humans"---leaving consumers as “the test case”--it was even more difficult “to have the scientific discussions" needed on the topic.
  • Questions from the public delved into impairment risks, a state hemp in foods task force, federal drug development, and age restrictions on cannabinoid products. 
    • Jim MacRae, Straight Line Analytics Founder, thought the discussion was fascinating but remained curious how panelists would suggest WSLCB staff “determine and define what is and is not impairing.” Then with regards to risks, he asked whether panelists “agree that, relative to the alcohol and nicotine also regulated by the WSLCB, cannabis represents the least risky alternative for adult use?” (audio - 6m, video)
      • Schauer made the case that “decisions should be made more on treating cannabis as a single plant” with a primary regulator evaluating the end use of different items, be they for patients or adult consumers. She hoped to get the regulator for cannabis and hemp products “similar across the board” and repeated the potential for a “multidisciplinary” state task force to find solutions. She felt the WSLCB staff discussion on impairment "oversimplifies” the problem and didn’t serve stakeholder needs.
      • MacRae's secondary question about the relative risks of cannabis products compared to alcohol or tobacco missed the point for Carlini, who felt “we don't know now what cannabis…has become anymore.” She admitted when I-502 was on the ballot, she “wasn’t aware [voters] were also voting for…a for-profit industry,” projecting many Washingtonians may have been unclear that products would be “mass produced and marketed.” Carlini recognized the “rationale” behind MacRae’s inquiry was “appealing,” but her emphasis continued to be on the risk of cannabis itself, not whether it was less risky than other recreational substances, as she wasn’t sure that was true “anymore.” She conceded when it came to cannabis use, flower was “clearly the least risky alternative.”
      • Freng spoke of “physiological risk” (which he felt alcohol and tobacco posed to a greater degree than cannabis) and “psychoactive risks” (with tobacco posing no risk “whatsoever” in this regard). He found the psychoactive risks for alcohol and cannabis to be comparable, and felt that both risk “dimensions” should be weighed by regulators.
    • Ryan Bowman considered the state to be a “forerunner” of cannabinoid policy making, and encouraged a different approach than the one taken for opioids which “hasn’t had [a] very good track record." He speculated that a dedicated state agency for hemp regulation could be better at overseeing the varied uses of the crop, feeling the “psychoactive thing…is a very small portion of that." If there was a regulatory body where leaders “had more knowledge about this stuff,” they could leverage existing research on cannabis, which he pointed out had been studied for decades but “seems to not be known, ‘cause it’s kinda been skipped over here.” Having used cannabis as a medicine, Bowman hoped to see officials “devoted to” becoming familiar with the long medical history of the plant while creating regulations around it (audio - 5m, video).
      • Nordhorn cut off Bowman, feeling the dialogue was for questions for the panel, rather than participant “use…as a platform.”
      • Schauer responded that states with “one umbrella” for cannabis and hemp regulations focused on “hemp-derived products” for human consumption, and other items like “textiles, rope, microgreens” were regulated by state departments of agriculture. Even if these products were regulated differently than medical or adult-use cannabis, she commented that they’d still be within the same framework for regulatory authority. But absent “federal engagement,” Schauer was doubtful states would make consistent standards.
      • Learn more about hemp regulation by the Washington State Department of Agriculture (WSDA).
      • See Bowman discuss cannabidiol (CBD) in a YouTube video from January 16th.
    • Shawn DeNae Wagenseller, Washington Bud Company Co-Owner and  Washington Sun and Craft Growers Association (WSCA) Board Member, attempted to ask about other agency engagements for policy input but Hoffman declared this was “off topic” (audio - <1m, video).
    • Bonny Jo Peterson, Industrial Hemp Association of Washington (IHEMPAWA) Executive Director, wondered about the Washington State Hemp in Food Task Force as she’d been "heavily involved with writing the hemp program" in 2019 in addition to writing “multiple pieces of legislation up to this point.” Aside from elaborating on the “structure and function” of cannabinoids, she asked what else the task force “should be discussing in that realm” (audio - 2m, video).
      • Schauer was fine with more work to define impairment from cannabinoids, but aimed for regulations with a “base consumer safety perspective in mind” along with “layers of regulations” for some items with the input of industry; public health and prevention interests; regulators; and scientists.
    • An attendee named Joanna asked if state officials used “a clear definition of psychoactive" (audio - 3m, video).
      • Typically avoiding that term, Schauer reported that at the most basic level the word meant a substance “works on the brain" which she felt could include any cannabinoid. She previously used the phrase ‘psychotropic’ but found there were “challenges” with defining that word as well.
      • Hoffman relayed that the agency had used “psychoactive" but had moved to use "impairing," though she conceded the definitions had been “very hard” for staff to “get our arms around.”
      • “Mind altering” was terminology that Carlini had seen used, adding that CBD was considered psychoactive but “not mind altering.”
    • Wagenseller mentioned that hemp seeds and oils were generally recognized as safe (GRAS) in food items, but Schauer drew a distinction between “manufactured food products that are not…in the vein of hemp seed oil.” Their concern was for rules on cannabinoid “dietary supplements and beyond" (audio - 1m, video).
    • Peterson advocated for “a class system…to put the end products into a specific category” (audio - 2m, video). 
      • Schauer was in agreement that a system like that “was needed here,” believing a task force could organize those classes and that it was “more advantageous” to have a single regulating agency “over all of those.” Varying regulatory bodies meant, “inevitably, new things will come up” and separate entities increased the chance of products falling “between the regulatory cracks,” Schauer argued.
    • Wagenseller asked panelists about drug development protocols of the U.S. Food and Drug Administration (FDA) and whether the “path of…designer medicine" was more appropriate when specific amounts of cannabinoids were compounded together instead of a “whole plant” (audio - 6m, video).
      • Freng was skeptical that “we need more bureaucracy, frankly," around cannabinoid products.
      • Schauer recognized that "there’s a bunch of different decision points," particularly with regard to “not found in nature cannabinoids that are coming out” and were unlike any naturally-occurring cannabinoids researchers had seen. She was concerned about biosynthetic cannabinoids, as in other products biosynthesis was regulated by the FDA, but no “one’s holding their breath” for federal authorities to “get in the game here." If state laws continued to take different approaches, some “banning not found in nature products" and others allowing them “on their medical or adult-use markets,” she anticipated a patchwork of policies that wouldn’t be especially effective. Schauer suggested one national coalition that could improve the situation was CANNRA but they were limited by the inaction of federal officials.
      • Carlini considered society to be “paying for the prohibition of the plant” as the pathway for medical use of cannabis had been “underdeveloped, particularly in the United States” leaving the nation without access to Sativex, a pharmaceutical sold in 42 countries. She nonetheless found this was “unrelated” to sales of cannabinoid items without age restrictions or other regulations.
    • An attendee named Scott remarked in chat that “Categorizing products seems like a time-intensive process. In the meantime, there is a present challenge with youth access to hemp-derived synthetics. Does it make sense that we would focus first on age-gating these products and then do the work regarding product categorizations?” Hoffman promised to give panelists a chance to respond to his question later via email (audio - <1m, video).

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