WA Senate LCTA - Committee Meeting
(May 10, 2022) - Work Session - Regulating Hemp-Derived Cannabinoids

Cannabinoid Regulation - CBD - D8 - THCP - THC-O-Acetate
[ Event Details ]

Lawmakers learned about cannabinoid synthesis and potential health risks before hearing an overview on relevant cannabis policy from WSDA and WSLCB representatives.

Here are some observations from the Tuesday May 10th Washington State Senate Labor, Commerce, and Tribal Affairs Committee (WA Senate LCTA) Committee Meeting.

My top 3 takeaways:

  • Portland State University (PSU) Organic Chemistry Professor and Strongin Lab Director Robert Strongin provided an informed perspective on chemical synthesis using hemp-derived cannabinoids as well as the state of cannabinoid knowledge and research (audio - 15m, video).
    • Strongin conveyed that he attended at the committee’s invitation to discuss “the chemical synthesis of hemp-derived cannabinoids and their transformation to other” cannabinoids for use in consumer products “and to talk a bit broadly about safety and any other potential unknowns or concerns.”
    • Strongin utilized the term “semi-synthetic cannabinoids" to describe compounds synthesized using hemp-sourced molecules with other reagents. He distinguished synthetics like Spice and K2 as coming from “other starting scaffolds” and therefore “not really structurally related" to tetrahydrocannabinol (THC) or cannabidiol (CBD) “but may have analogous effects." By contrast, semi-synthetic cannabinoids had seen “a resurgence lately," Strongin told the committee, in part because it starts “from a molecule whose activities [are] already known," in this case CBD. Slight changes in CBD compounds meant that “new properties are attained” which may be good or “toxic,” which was “what gets studied.” He clarified this was “essentially what people do in…the pharmaceutical industry as well."
    • The 2018 Federal Farm bill led to a “kind of perceived loophole" in federal policy whereby “the creation and marketing of these semi-synthetic cannabinoids” from CBD could be done, Strongin asserted. Indicating that academic writing on CBD synthesis had been published “dating back to the 1940s," he said that synthesis was achievable in laboratories “or even in one's home, unfortunately." With texts on “treating CBD with” acids and other processes to create semi-synthetic cannabinoids available, he remarked that minor changes in process could “favor the production of one of these over another.” Strongin considered the chemistry involved to be “relatively easy,” and that processes were already being refined “and improved upon by people in this industry as we speak.” The transformation of “CBD to delta-9-THC,” which he found to be the “most prevalent and psychoactive” cannabinoid, was established chemistry and creation of other cannabinoids was increasingly common given the compounds’ “unclear legal status.”
    • Strongin was concerned there was a public perception of CBD as “harmless” and theorized that view “could carry over” to other semi-synthetics even though the U.S. Food and Drug Administration (FDA) “does recognize that CBD may induce toxicity” in the liver. A lack of knowledge about the interaction between other drugs and CBD left him concerned about potential impacts like “male reproductive toxicity in laboratory animals." Strongin then identified “concern over the claimed benefits of CBD…and these analogues” because there had yet to be “evidence from human clinical trials,” although such trials couldn’t be conducted legally in the U.S.
      • Human clinical trials involving cannabinoids had previously been undertaken in other countries like Canada, Australia, and the United Kingdom, sometimes in cooperation with U.S. institutions.
    • Another area of concern for Strongin was that semi-synthetic cannabinoids, while easily created, were “really hard to separate and analyze" as their “physical properties” were similar. He claimed it would be difficult to determine purity even by "best equipped labs" and said "there's overlap between these cannabinoids that goes unrecognized by the manufacturers.” The result was inaccurate labeling of semi-synthetics from businesses that “just don’t have the instrumentation or know-how to understand how to see that.”
    • Strongin noted that a commonly produced semi-synthetic was delta-8-THC, a compound “naturally occurring in the plant" in such low amounts that it is only commercially available due to CBD synthesis. He stated the compound had become popular in regions without legal adult-use cannabis and was "reported to possess about 70% of the psychoactive, high-inducing potency" of delta-9-THC. But like most semi-synthetics “very little” was known about the potential health benefits or risks, indicated Strongin, besides it being similarly psychoactive to delta-9-THC.
    • Another newer semi-synthetic Strongin had encountered with increasing frequency was tetrahydrocannabiphorol (THCP), which he mentioned was created from hemp crops with more cannabidiphorol (CBDP). He told the committee that THCP has “two more carbons as part of the molecule” and was suspected of being “many, many more times more potent than delta-9-THC.” Strongin said this went beyond “anecdotal reports from users” claiming they “haven't even recovered from” consuming the compound until “the next day.” He told lawmakers of studies indicated THCP caused “33 times more activity at the cannabinoid receptors in the brain.” In his opinion, “cannabis is already potent enough.”
    • Acetylation was a process that could “enhance” potency for both delta-8-THC and delta–9-THC, according to Strongin, by synthesizing them into THC acetate ester (THC-O-acetate). He pointed out this was the same chemical process through which morphine was transformed into heroin. THC-O-acetate was able to cross the blood-brain barrier with more ease, meaning the resulting "psychoactive effects are much greater."
    • Though not wanting “to be alarmist,” Strongin found that semi-synthetic cannabinoids "are getting more and more prevalent and we don't understand them." He hoped his overview could “touch the surface” of the topic without being overwhelming. Chair Karen Keiser expressed gratitude for Strongin’s work and insight (audio - <1m, video). 
    • Vice Chair Steve Conway had a question on regulation, believing that when cannabis was legalized, voters had been “talking about the cannabis plant, and they were talking about the use of cannabis.” Since officials regulated cannabis production and processing, he asked if more should be done to regulate those undertaking semi-synthetic chemistry. Though the federal prohibition on cannabis remained a problem as it limited research of the compounds, some substances had been legally obtained by converting CBD and Conway wanted a sense of where laws and oversight should be applied (audio - 5m, video). 
      • Strongin considered current law to have created a “loophole" that allowed the creation of semi-synthetic cannabinoids, and while “it could be that these turn out to be perfectly harmless materials. I doubt it." He considered the unregulated chemistry at the heart of the process to be "analogous to" creating variations on chemicals like methamphetamine. Strongin’s view was that these processes "absolutely” needed to be regulated, but that would be complicated since "transformations can be done in somebody's kitchen" and information on the process was widely available online. He recognized the situation as “a tough problem" but also “important” to address.
    • Senator Mark Schoesler wondered if a distinction could be made between hemp fibers and hemp oils, asking if hemp oils were being chemically modified into delta-8-THC, but not the hemp fibers. Strongin wasn’t certain, replying that “the chemical process comes from CBD.” Schoesler thought looking “at where the future goes here, we’ve been talking about legal hemp as long as I can remember” and that it “was always going to be a miracle crop for the fiber.” Now he saw “the seed and the oil” as a more valuable market, and figured if “that’s where the problem is, perhaps that’s where we should be looking” to regulate. Strongin cautioned that those engaging in "this kind of work…they're really good at moving targets, when you regulate one," participants might move to a different process if only certain parts of hemp plants were regulated (audio - 2m, video). 
    • Senator Rebecca Saldaña asked how Strongin’s work was funded, indicating that lawmakers were considering increasing funding for cannabis studies by Washington researchers. She expressed a particular interest in hearing “about dabbing” as it appeared to her to be an “epidemic with young people.” Like the difference between beer and “pure alcohol,” Saldaña spoke of the “intensity and the damage” concentrated cannabis products could cause youth. Saldaña hoped to hear about “education and prevention” strategies as well (audio - 5m, video) 
      • Noting that the Strongin Lab had released research on cannabis dabbing in 2019, Strongin explained they’d evaluated ketene formation in dabbing, concluding that there were a lot of unknowns around methods of administration, but he expected dabs had "way more exposures to toxins" and carried "way more risk."
      • His funding had taken two years to arrange, and the process was "so hard" to obtain a federal Schedule 1 research license. He learned he was risking losing federal funding “not just for myself, but for my university.” He couldn’t buy state-legal cannabis sold “blocks away” from his campus, though he could procure cannabis “for my own personal use, if I ever wanted to do that.” Strongin attributed this difficulty as the reason there were “so few researchers like myself in the field," and increasing focus on CBD and delta-8-THC products which could be legally sourced “as far as we know…or at least not enforced.” He remarked that his team had “bought analytical standards” and used an expensive process to refine and combine them for testing. Strongin wrapped up by encouraging committee members to support expanding research in Washington before Keiser thanked him again, requesting that “once your…study is peer reviewed, could you share that with us?” (audio - <1m, video).
      • Other research articles on dabbing cannabis concentrates include:
  • Washington State Department of Agriculture (WSDA) Policy Advisor to the Director and Legislative Liaison Kelly McLain provided legislators a briefing on the department’s hemp program before taking questions (audio - 9m, video, presentation). 
    • In April 2019, McLain testified before the Washington State House Commerce and Gaming Committee (WA House COG) on how CBD was being regulated by WSDA staff. She had since testified on several cannabis bills, usually taking a neutral position on behalf of the department:
    • Speaking to "what we're seeing in our hemp space," McLain first acknowledged the background of the program. She reported that in 2021 the hemp program had “115 growers producing hemp for a variety of commercial purposes throughout the state.” She noted a variety of regulations in the department’s program:
      • Mandatory licensure of hemp producers
      • Required testing for hemp crops harvested “for commerce”
      • Limits on THC content of 0.3% “otherwise the crop must be remediated or disposed of using department approved methods”
    • After these steps, WSDA staff had no regulatory role in the subsequent processing or resulting products, stated McLain. She cited RCW 15.140.040(5), part of a hemp law passed in 2019, as making it “illegal” to put hemp extracts like CBD in food “or ingestible products” for sale in Washington, although “whole hemp hearts,” hulled hemp seed, were allowed. McLain understood that a variety of CBD and hemp products with synthesized cannabinoids were available in the state “but [they are] not legally supposed to be.”
    • For 2022, McLain anticipated there being “about 70” licensed producers, with the greatest concentration being “in the Yakima region.” She pointed out that most hemp was grown outdoors, but there were a few “indoor and greenhouse producers” as well.
    • WSDA officials submitted data on production to the U.S. Department of Agriculture (USDA) each month, she commented. In a survey of licensees about the reasons they intended to produce hemp, McLain said responses showed growers were very "cannabinoid centric" but produced hemp for a number of reasons. Her presentation showed 45 out of 70 intended their crop to be used for cannabinoid extraction, 33 “for smokeable hemp,” 24 for both seeds or fibers, and some other uses.
    • McLain acknowledged Strongin’s remarks and concurred there was “a lot of interest in doing research in this space." She then noted that WSDA leaders were standing up a Hemp in Food Task Force based on a supplemental budget appropriation approved on March 31st and would investigate “hemp derivatives as ingredients in food.” While cannabinoids hadn’t been allowed in food in the state so far, McLain recognized there was "significant interest" in the compounds, so the task force would release a report on the topic by December 1st. She said this might include "an identified pathway" for sales of CBD products outside of adult-use cannabis retail stores, and commented that several stakeholders indicated this was the “ideal” outcome for the group’s work.
    • Keiser inquired about limitations on the import of CBD extracts, and McLain replied there were no limitations for either end products or CBD distillate. Keiser shared her understanding that the material was being imported into Washington. McLain relayed that Washington hemp producers harvested about 10% as much hemp as Oregon cultivators, so most cannabinoid products in the state came from hemp produced elsewhere (audio - 1m, video).
    • Conway wanted to know where Washington hemp being grown for cannabinoids was ending up if their addition to foodstuffs was illegal under Washington law. McLain answered that a “significant amount” of CBD from Washington hemp was being exported, but other hemp licensees partnered with a cannabis business to have their cannabinoids used in legal cannabis items (audio - 1m, video).
    • Saldaña asked whether state agencies were choosing “not to enforce” the law if cannabinoids were illegal in foodstuffs. McLain replied that there wasn’t a “regulatory structure setup for enforcement of legal versus illegal access.” She believed this would be the purview of local health jurisdictions and also believed these entities lacked funding for enforcement since cannabinoid products became prominent. McLain further anticipated there would need to be a “pretty significant investment and infusion into the local health jurisdictions” to encourage their leadership to take action on the illicit products (audio - 1m, video).
  • WSLCB Director of Policy and External Relations Justin Nordhorn gave an update on agency activity around cannabinoid regulations and their goals going forward, then fielded committee questions (audio - 13m, video, presentation). 
    • Nordhorn’s comments were a mix of things previously disclosed with some new information. He pointed out that agency leaders had asked for request legislation on cannabinoid regulation during the 2022 legislative session due to concerns over “youth access, consumer safety, and also employee safety on the manufacturing front." Nordhorn referenced continuing efforts by agency staff to define and quantify cannabinoid “impairment,” like a deliberative dialogue session covering the topic on April 27th, as well as what cannabinoid interactions might “lessen” impairment impacts.
    • Agency officials were also seeking to assess impacts on the existing marketplace, he said, like “product innovation…and then are we going to be prepared for federal legalization?” Nordhorn also brought up previous engagements by WSLCB staff with the public, other agencies, and cannabis associations and trade groups on the topic. He felt there’d been general support for their request bill, which was repeatedly modified at stakeholder request, but that “nuances” had become an issue during the legislative session which merited “further exploration.” 
    • Nordhorn remarked that WSLCB legislative goals centered on both safety and health, particularly when it came to youth access or use of cannabinoid items. He also made clear an intention to support cannabis industry interests and development of a “framework” for regulating the products. One aspect in place currently was testing imported cannabinoids, which Nordhorn noted included heavy metal testing as one way to lower risks to consumers.
    • He anticipated an expanded emphasis by regulators on "age restricted" products, calling out how grapes weren’t restricted under state law, but wine, a product made from them, was. Similarly hemp material wouldn’t make a person “intoxicated,” Nordhorn asserted, but “as it gets converted…you could end up with a product that” may need to be age-restricted. He added this had been easier to implement with alcohol than for cannabis, where a clear standard for cannabinoid impairment had yet to be identified by experts.
      • The Washington State Supreme Court upheld an impaired driving standard for cannabis in a ruling announced on May 13th. The court unanimously affirmed the constitutionality of a per se driving standard, noting that because “the plaintiff’s own expert council had testified that some people are impaired by a THC concentration of 5.00 ng/mL,” that provision of the law had a constitutional basis. In their opinion, justices noted that “if someone has a [blood alcohol content] above the legal limit, they are guilty of DUI even if their driving is not impaired. The same is true for consumption of cannabis and driving.”
    • Nordhorn communicated that WSLCB leaders were still looking at "how do we create that line and threshold" for impairing cannabis products. Looking at standards in other states, Nordhorn offered:
      • Oregon - “Adult Use Cannabinoid”
        • “Includes delta-8 THC
        • Any artificially derived cannabinoid reasonably determined to have an intoxicating effect
        • Artificially or naturally derived tetrahydrocannabinolic acids
        • Industrial hemp commodity or product exceeding THC concentration levels established by OLCC in rule
        • OLCC set a 0.5mg THC limit on hemp products”
      • Colorado - “Adult Use Cannabis Product”
        • “All intoxicating cannabinoids
        • Artificially derived cannabinoid or industrial hemp derived product not defined as industrial hemp product
        • Any other chemical substance not defined in statute and that is identified by rule”
    • While WSLCB officials lacked oversight over hemp-derived cannabinoids until they were used in legal cannabis products, Nordhorn mentioned that other legal cannabis states allowed regulators to be involved in hemp production and processing. He shared a timeline for the agency’s interim policy outreach and rule development planning for the next year, including more deliberative dialogues scheduled with new expert panelists in May and June. Nordhorn also addressed the cannabinoid rulemaking project, making clear there would be public engagements.
    • Nordhorn stated that the board was aiming for a more modest legislative proposal in the 2023 legislative session. He noted there was planning underway for a “technical work group” at the agency to offer “advice and insight.”
    • Keiser remembered having seen a communication to licensees from WSLCB that if they were selling “these cannabinoid products” their licenses “could be in jeopardy.” She asked for additional information (audio - 2m, video). 
      • Nordhorn explained that existing law for alcohol and vapor licensees barred them from allowing "criminal conduct." Agency officials had received guidance that delta-8-THC was still a controlled substance, so selling unauthorized items may constitute criminal conduct. He clarified that tobacco licensees lacked this provision, “and so, we have gaps there.” The Enforcement and Education division at WSLCB had made some seizures, indicated Nordhorn, and continued to collect data.
    • Conway expressed some surprise about 2021 legislation passed in Oregon, HB 3000, where regulators “took it upon themselves to regulate…semi-synthetic products.” He wondered if WSLCB staff intended to move in that same direction using HB 3000 as “a model” (audio - 5m, video).
      • Nordhorn articulated an intention of agency staff to “stay within the lane of the LCB regulatory authority." Claiming staff were not interested in regulating “non-impairing hemp products,” he said ambiguity around what cannabinoids were impairing led to confusion by some in the cannabis sphere over who would regulate specific compounds. OLCC had already regulated hemp and could more readily promulgate regulations on cannabinoid items.
      • Conway followed up to inquire whether Nordhorn believed WSLCB should be given that authority since the path for regulators in Oregon had “been a tad bit easier" and lawmakers had an “obligation” to better regulate cannabinoid products. Nordhorn replied that there was a gap between hemp "harvest and the sales" but that WSLCB had been focused on compounds “causing concern around impairment” and wanted regulatory authority over them. HB 3000 "is a very interesting policy development" and could offer potential solutions, he stated.
    • Senator June Robinson was curious about the role of the Washington State Department of Health (DOH) in this process, asking about WSLCB engagement with the department and ways they could work “hand-in-hand" on the issue (audio - 4m, video).
      • WSLCB staff engagement with the department had focused on preventing youth access and administering a medical cannabis program, Nordhorn responded. He noted that the department didn’t “typically have a strong connection on the health implications” of specific product types but their request legislation had included a more prominent partnership between WSLCB, WSDA, and DOH staff on determining if a compound could be used in products beyond legal cannabis retail. Nordhorn anticipated more opportunities to engage with DOH and get their input on cannabinoid items and standards in the future.
      • Keiser recommended a more “serious look” at compounds by DOH officials with emphasis on “the potential health effects.” Nordhorn concurred with her, saying there was a concern “about byproducts” and a need for labeling synthetically created cannabinoids.

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