WSLCB - Work Group - Cannabinoid Science - Public Meeting
(June 1, 2023) - Summary

WSLCB - Work Group - Cannabinoid Science - Public Meeting (June 1, 2023) - Summary - Takeaways
[ Event Details ]

The group contemplated human safety guidance for different cannabis products, research on growing cannabis in contaminated soil, and implementing a new standard for THC detectability.

Here are some observations from the Thursday June 1st Washington State Liquor and Cannabis Board Cannabinoid Science Work Group (WSLCB - Work Group - Cannabinoid Science) Public Meeting.

My top 3 takeaways:

  • WSLCB Research Manager Kathy Hoffman posed questions to work group members related to human safety guidance for differing cannabis product types.
    • The agenda indicated all the subjects to be discussed represented a continuation of their April 6th conversation on “Diminishing the gap between scientific expression and regulatory/statutory expression. Creating an agreed upon language or nomenclature around the terms we use.”
    • Hoffman told work group members agency representatives wanted “to focus this time on some of the talking points that came up in between our meetings,” with the first being “Human Safety Guidance.” She asked about guidance based on product classification, instead of for the cannabis crop generally, “since safety around consumption method[s] could be very different” (audio - 3m, Video - WSLCB).
      • Verda Bio CEO Jessica Tonani observed that consumers could buy cannabis flower, as well as infused edibles and inhaled concentrates, and that after adult-use cannabis had been legalized officials “classified those products as all containing the same risk for every contaminant.” She felt this was “probably not accurate, and we have the opportunity now, ten years later, to maybe begin to look at those classes [based upon] what risks do they actually hold.” Tonani suggested food with “a fraction of a drop” of cannabis oil carried different contamination risks than “inhaling an entire gram of floral material.” Her hope was for the group to “break those product classes out, and actually look at contaminants via safety, based upon those product classes.”
      • Hoffman wondered how products might be classified while centering “human safety guidance, how do we break that down,” or “parse that out” in regulations.
    • Tracy Klein, Washington State University (WSU) VancouverAssociate Professor and Center for Cannabis Policy, Research, and Outreach (WSU CCPRO) Assistant Director, inquired about any standards for product classes in current rule. Tonani responded that there were groups, but within those all products were “billed as the same thing,” as any serving of an edible was limited to ten milligrams, regardless of the type of consumable it was. She expected it would be possible to “break out the safety a little bit better, because right now…they're all considered to be the same thing with the same thresholds” (audio - 3m, Video - WSLCB).
      • Brad Douglass, Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry, argued from a “toxicological perspective, it certainly makes sense to have different standards, or tolerances, for contaminants, for different routes of delivery.” He found the “challenge is one of practicality. We know that for pesticides in particular, there's data gaps, knowledge gaps in terms of the toxicology, chronic versus acute, toxicity for individual pesticides, or pesticide classes” which “just exponentially increased when you go to something like inhalation versus ingestion, or topical or combustion.” Douglass saw this as an obstacle both scientists and regulators would need to address, but only after acquiring “enough data to be able to have different product classes, or different levels for different routes of administration,” something he argued posed a “monumental challenge.” Hoffman agreed, and felt it was a matter of “how do we start developing that data.”
    • University of South Carolina School of Medicine Columbia Postdoctoral Fellow and researcher Taylor Carter then wondered how State officials “work with regulating pesticides for other non-cannabis related crops in the state” and were there thresholds for “eating a crop or consuming a crop in different forms, whether they're processed or not” (audio - 3m, Video - WSLCB).
      • Tonani’s understanding was that foods, for example, “apple versus mint, have different thresholds because it's…assumed that you eat less mint than an apple.” Because of this, she wanted to identify “proxies” for cannabis product classes, noting that cannabis concentrates may be “somewhat unique and maybe needs to be a little bit more strict,” but proxies for foods or combusted plant matter should be identifiable. 
      • Holly Moody, Infinity Laboratories Senior Scientist and work group co-chair, relayed that he’d analyzed “residuals in concentrates, and that’s mostly where you're gonna get those because you don't use…your butanes and your hexanes and stuff on flower.” However, he was aware some edibles had a “full flower source or [a] concentrate source,” and that if there was a “small amount of pesticide, for instance, that's contained in a batch of flower…and you extract that out with some sort of a carbon-based solvent, anything that dissolves in that as pesticides will wind up in a higher concentrated form in your concentrate.”
    • Hoffman asked about proxies for cannabis products, and whether “anyone had any experience with that now,” but no one spoke up with examples (audio - <1m, Video - WSLCB).
    • Tonani believed addressing “what is safe soil for our farmers” could be done “maybe using WSU, or somebody else we can actually begin to look at what levels in the soil correlate to what levels in the floral material.” She indicated this correlation had been identified in other crops. Hoffman was curious whether WSDA had data along those lines. Nicholas Poolman, Washington State Department of Agriculture (WSDA) Cannabis Lab Accreditations Standard Program (CLASP) Chemist, doubted that information was “in a ready, or easily accessible way to use.” Douglass told the group there was a decent amount of tobacco toxicology data, acknowledging “in the cannabis world, we generally frown upon comparing ourselves to tobacco, but there's a lot of similarities there from a scientific perspective” relevant for establishing “inhalation-based tolerances or action levels” (audio - 2m, Video - WSLCB).
    • Hoffman wanted Douglass to “speak a little bit to that concern” of comparing “cannabis to tobacco” as WSLCB staff had heard “very frequently” to regulate cannabis like tobacco as the products were “essentially the same thing”  (audio - 3m, Video - WSLCB).
      • “Maybe I can characterize it as emotional,” Douglass said of the perception that “tobacco [was] bad, and cannabis [was] good, in very stark…black and white terms.” He acknowledged “there might be different…pesticides and other contaminants on the different crops, but there's a lot of crossover, too.” Douglass expected there would be “some good data that we can draw upon to…maybe make policy.” Tonani emphasized that for legacy pesticides like dichlorodiphenyltrichloroethane (DDT) “there was some pretty good data on when you combust plant material with the DDx's on what…actually ends up being inhaled.”
      • At a Society of Toxicology Conference, Taylor mentioned that Maxwell Leung was an Arizona State University researcher who looked into “carryover” when designing pesticide limits for that state’s cannabis program. “So he may be probably the leading researcher in this direction of what's carrying over, [and] what effect is it having,” Taylor said, suggesting officials look at his research for a “baseline of actual cannabis effects at certain levels from the actual crop.”
    • Next, Hoffman raised the issue of “data holes,” asking the group “what are we missing? And what do we need to look for in order to create these proxies?” (audio - 2m, Video - WSLCB).
      • From Tonani’s perspective, identifying proxy products was key to figuring out what data was needed. She argued cannabis concentrates presented “a pretty decent data hole,” but she was also concerned about having “less data than we think on what safe soil is for this crop, and that there's the ability,” particularly for hemp researchers, to “actually grow in contaminated soil, and measure, and determine what those thresholds are.” Tonani said this was a data gap they could “fill in” if Washington officials encouraged study, as it would “enable safer grow[ing]” of cannabis in the future.
      • Cannabis Observer Founder Gregory Foster called attention to the fact that “This past session, the Washington State capital budget (SB 5200) included $5M for soil cleanup added late in the process in order to help agricultural sectors—including cannabis licensees—in north central Washington.  The Department of Ecology is on point for that in collaboration with WSLCB.”
    • WSLCB Director of Policy and External Affairs Justin Nordhorn commented that “we've seen some comparison, particularly recently with the DDx issues, around thresholds for tobacco versus cannabis” and he wanted to see “some bifurcation between the inhalables [sic] that are combustible, versus other types of products that are concentrated, because there's there's definitely gonna be a different threshold.” He’d appreciated the feedback that different products “affect people differently based on that product type” (audio - 2m, Video - WSLCB).
      • Douglass believed there would be “case studies” on compounds showing some could be safe to eat, but not to breathe, or compounds with different health impacts based on whether they were combusted before inhalation or not. He named myclobutanil as a fungicide which can “combust and break down into hydrogen and cyanide,” while vitamin E acetate—widely blamed for outbreaks of vaping associated lung injuries in the fall of 2019—was “perfectly okay to be ingested, but when it's combusted or heated to a high temperature, can have degradation products that are harmful.” He said agency leaders needed to be mindful of “degradation products” created during a compound’s combustion, and “highlight those for…specific differences between ingestible products or inhalable products.”
    • Hoffman concluded “we're in the very early stages of…thinking about” human safety guidance, and they could “separate that out” by product to determine “what kind of recommendations this group can make to LCB.”
  • The group then talked about best practices for cannabis production, with an emphasis on avoiding plant contamination through soil safety.
    • Hoffman immediately turned to Tonani, who had “started to talk about this. How does the level of a contaminant in the soil affect floral contaminant levels” for cannabis? (audio - 4m, Video - WSLCB)
      • “My thought is, is that there's a lot of urban legend, and there's…potentially maybe some truth to the urban legend about cannabis accumulating some of these compounds but it may not accumulate all of them,” Tonani established. She continued, stating that in other agricultural commodities, experts could “correlate the soil to the product that's being produced and consumed by humans.” Tonani considered it “hugely valuable to our producers which…quite frankly are just really farmers” who lacked an “ability to do what other farmers in the state do which is determine what safe soil is so they can make safe products. Right now, safe soil has nothing in it, which unfortunately, we don't have a lot of that soil left in the U.S. to grow on.” She urged officials to “grow hemp in contaminated soil and look at what happens to the floral material, and look at accumulation levels,” feeling that research in this area was not “out of the reach of what we could accomplish.”
      • Taylor’s understanding of hemp was the “stem itself doesn't really hold a lot of the heavy metal.” He used cadmium as an example, asserting the highest levels of the metal would be found “in the leaves, then the roots, then the stems, then the seeds.” He remarked that someone would “almost have to do an exact study on the exact thing you're looking at in the exact situation, because any sort of comparison in any sort of dynamic you're going to see a shift, and then you may take an assumption like, ‘oh the stem was fine…there's not much cadmium.’” Taylor had seen more research on the matter getting published but it was a “tough road” to figuring out what metals could accumulate in different parts of the plant. Tonani responded, “that's why we would have to probably limit it to like oil producing hemp…and then look at the floral material” and be “very clear on” what plant matter was considered “analogous to what people are consuming” in the legal cannabis market.
    • Douglass agreed that there was some research about cannabis absorption of heavy metals, but asked Taylor if he knew “of any data showing hemp to be a, even by class, a pesticide accumulator?” Taylor pointed to work by Leung and others which studied pesticides’ impacts “far downstream at the actual neurological effects.” His impression was that metal absorption had been studied more “because it can be done in the lab setting,” whereas data on pesticide accumulation in cannabis was less “clear…I don't think there can be…a direct comparison” (audio - 2m, Video - WSLCB).
    • Then, Douglass raised the question of what funding sources existed to conduct this kind of research. Tonani replied that agricultural commissions overseen by the Washington State Department of Agriculture (WSDA) had undertaken similar work for other crops, “and they've just been grown so long that I don't know who along the way did them,” speculating that federal agencies contributed to some research. She asserted the “reality is…a lot of crops are grown in contaminated soil, and…most of our soil does have something in it at some level.” Hoffman was curious if other legal cannabis states had looked at the problem, but Tonani wasn’t aware of published articles (audio - 1m, Video - WSLCB).
      • Legislation to allow licensed producers to vote on potentially setting up a cannabis commodity commission was passed by the Washington State Senate (WA Senate) on March 8th. Though the bill wasn’t approved by the other chamber, at publication time it remained active through the shorter 2024 legislative session.
    • Hoffman opened the discussion to “any studies we could explore doing in the state on hemp with our local universities” which might involve accessing “larger testing networks across state lines to help generate that data.” Klein wasn’t aware of anything and Tonani pointed out since hemp was already a commodity sold between states, the testing “for some of these pesticides, in order to get more than one lab to test it so that you can…confirm your test, oftentimes does require sending across state lines,” which was another reason she felt studies involving hemp plants would be more viable than cannabis (audio - 2m, Video - WSLCB).
    • WSLCB Policy and Rules Coordinator Cassidy West spoke up to share that she’d found U.S. Department of Agriculture (USDA) research on “risk assessments the FDA and USDA have done…using different inputs for soil.” She promised to pass on relevant information to work group members (audio - 1m, Video - WSLCB). Hoffman recognized “we're not at a point where we can really start framing guidance in this discussion today…we need to do some more research” (audio - 1m, Video - WSLCB).
    • Poolman returned to the matter of product proxies, noting new foods had been compared with the closest related crop, offering that avocadoes and hops were compared for “similar fat content, or carb content, or water content.” He continued, stating the “cannabis plant [was] generally pretty fatty” and had “different growing systems,” so while studying them was “ideal,” he felt it was alright to settle for “plants that may have similar outcomes, or similar product types” (audio - 4m, Video - WSLCB).
      • Tonani highlighted that because edibles had a capped limit of tetrahydrocannabinol (THC), then food comparisons may be limited, asking everyone to “continue to remember the cap on the concentration, or the amount that can be in them and how that correlates to safety.” She suggested members “begin to look at the product classes, figure out a table to break that out…if that's a path we want to go on.” Hoffman liked the idea of starting “with the three we've got here: flower, edibles, and distillate” and would prepare a draft table for work group members to “sink our teeth into that in the next meeting, and perhaps in between meetings, start filling in some of the material that we want to have in that table.”
    • Douglass stressed the “importance of exposure, or different produce, or different things that you can be exposed to.” One way to track this was “a daily or expected serving so we understand the landscape of other exposures for particular contaminants.” Hoffman concurred the group should start to “integrate some of the nomenclature that we've put together” (audio - 2m, Video - WSLCB).
    • Richard Sams, KCA Laboratories Scientific Director, brought up the U.S. Pharmacopeia (USP) chapter of limits for elemental impurities which covered daily exposures based on consumption differences, and how that gets converted into action limits or thresholds based on route of administration. Focused on heavy metals, he still felt “it's applicable to what we've been talking about” (audio - 2m, Video - WSLCB).
  • Considering the implementation of the tetrahydrocannabinol (THC) regulation bill, SB 5367, agency leaders sought feedback on what constituted a “detectable” amount of THC.
    • Initially, SB 5367 was a WSLCB request bill limiting THC content in hemp consumables to one milligram (mg) per serving, and three servings per package. However, by the time the bill was heard by the Washington State House Regulated Substances and Gaming Committee (WA House RSG) on March 14th it had been revised to treat products with “any amount” of THC as a cannabis product. This led to confusion over how that would be determined by cannabis testing laboratories, and testimony from WSLCB Director of Legislative Relations Marc Webster asked legislators to avoid “unworkable" requirements. The legislation was amended to limit THC content to a “any detectable amount of THC.”
    • Beginning discussion at the work group meeting, Nordhorn talked about the history of the board effort to update cannabinoid regulations, describing how they’d moved on from “very complex” request legislation in 2022, shrinking the “focus down to the intoxicants.” When lawmakers attempted to have any amount of THC restricted, Nordhorn framed agency staff as “explaining to folks zero doesn't work,” and claimed “our position does not necessarily align with how the bill was ultimately passed.” He believed it would help keep “any type of THC out of hands of kids, however, [the bill] probably went a little too far” (audio - 7m, Video - WSLCB).
      • Nordhorn called out the exemptions for products approved by the U.S. FDA as well as for cannabis health and beauty aids (CHABA) as defined in law. “And then the other thing that we're not trying to engage with” was hemp which naturally could produce “0.3% THC on dry weight,” but “that's just the natural state of that, so we're really primarily looking at what is being sold to the consumer.”
      • Turning to “broad spectrum products,” Nordhorn said products with natural cannabinoids other than THC wouldn’t be under the authority of WSLCB. However, in reaching that point “we recognize that there's going to be product in the manufacturing process that has THC in it, and so…we really need to figure out” the best “pathway forward and I'm not sure that the LCB can resolve this on its own.” Nordhorn stated that “because there's no provision set forth in the statutory language that says” which agency was allowed to “adopt something that is going to be a standard for the State…I think this is really going to require some more legislation to get a fix.” He would be conferring with board members on the topic and welcomed any input from work group members on “solutions that would really recognize both of those industries without putting intoxicants in the hands of young folks.”
      • Nordhorn emphasized that the wording of SB 5367 wasn’t “something that the LCB was seeking as far as having this really low, or no detectable amount of THC.” He anticipated Enforcement and Education personnel would begin fielding complaints, especially for products advertising THC content, and anything with the compound would need to be sold in a licensed retail store. Nordhorn was confident anyone producing hemp products with THC for commercial sales would be covered under the law, “so I wouldn't recommend getting too much into the minutiae on what that's gonna look like, but…how do we move forward and what that looks like” was up for consideration since “lab testing has variables of uncertainty. And so therefore…zero just doesn't work.” In setting up a minimum standard for THC detectability, he asked for feedback on “what is a good reasonable application of this particular provision without trying to trump the RCW because we can't do that.”
    • Tonani’s understanding was that the detectable threshold would be set in rule since it wasn’t spelled out in statute through SB 5367, and asked WSLCB members “do you guys feel that you guys can't set that detectable limit?” (audio - 2m, Video - WSLCB)
      • Nordhorn affirmed that they would be limited in rule to stating a limit of detection “we expect labs to test down to.” He continued, “But at the same time if we were to say ‘you can have up to…two parts per million (ppm) in a level…if it's one part per million, it's still detectable and that goes against RCW.” He preferred a “common standard” cannabis labs could “test down to, and then…we're not going to, to necessarily dig deeper.” Nordhorn summed it up as “we can't come out and say ‘Here's a number,’ because if there's a number it's detectable.” He remained hopeful they would get input “because that is not really where we wanted to see the bill end up… and this is very much more complicated than we would have liked to have seen it.”
    • The next question on Tonani’s mind was the variability in laboratory testing equipment: “if somebody tests a product at a specific lab…working off of a certain…data set…and then it's tested on more sensitive equipment” she thought the standard of having a lab “test to this detectable limit, I guess…my concern is inversely if a lab tests on more sensitive equipment - where that liability falls.” Nordhorn suggested this highlighted the importance of working with WSDA officials on setting lab quality standards, since the department conducted testing on behalf of WSLCB. He added that labs may be better off disclosing “our equipment only goes down to a certain level, so…buyer beware” (audio - 2m, Video - WSLCB).
    • Sams called attention to Kentucky law which permitted hemp, but not cannabis, mentioning how authorities there were looking into delta-8-THC items. He’d found that when testing was conducted using high-performance liquid chromatography (HPLC), THC levels were always lower than when testing on more precise gas chromatography-mass spectrometry (GC-MS) equipment. Tonani clarified that under SB 5367, delta-8-THC was added into the THC content of a product since “all the THCs are not allowed” (audio - 4m, Video - WSLCB).
      • Nordhorn further clarified that the new law sought to limit both sale of naturally occurring cannabinoids, and prohibit manufacturing of synthetically created cannabinoids. He wanted to identify a “minute” level of the compounds, but “now we're stuck dealing with…the unintended consequences of this legislation.” Nordhorn reiterated that the goal was measuring THC content of an “end product” rather than an input like hemp, and Sams stuck by his view that “specificity of detection” was still important as he’d seen remediated product which still tested above the THC limit for hemp once tested with more sensitive instrumentation.
    • Klein asked where “transdermal” products such as a THC patch fit in. Nordhorn answered those items were already limited to sale by licensed retailers, and hemp processors couldn’t sell transdermal patches with THC (audio - 2m,  Video - WSLCB). 
    • Moody brought up how equipment detected THC-O-acetate, with Tonani explaining there was a total THC equation used by accredited labs. Sams mentioned how Kentucky testing utilized “BSFTA derivatization…and that preserves the carboxylic acid moiety,” but Poolman explained that approach wouldn’t work because private cannabis labs in Washington state relied on liquid chromatography for testing (audio - 2m, Video - WSLCB).
    • Returning to the issue of equipment sensitivity, Douglass talked about the “difficulties of sensitivity across product types,” giving examples of a “hemp concentrate that has one milligram of THC,” and a “hemp beverage” containing  “500 milliliters, that has one milligram of THC in it.” He asked, “What do you think about when you see those two different samples, when you're looking to not only detect but quantify the amount of THC that's in those two” (audio - 2m, Video - WSLCB).
      • Sams reported using an “internal standard method” that adjusted the amount of tested material “based upon label claims.” He remarked the sample prep was mainly dilution aiming to have the same amount of cannabinoid injected regardless of sample type, but acknowledged trying to identify 1 mg of THC in 500 milliliters of fluid was "somewhat more challenging” and would be done by extracting “cannabinoids using a liquid-liquid extraction procedure.”
    • West inquired whether cannabis testing could differentiate cannabinoids like delta-8-THC and delta-9-THC. Sams responded this was “readily accomplished” by GC-MS, but more difficult with HPLC equipment. Additionally, some impurities “coelute” and couldn’t be differentiated through “mass spectral methods,” he said (audio - 5m, Video - WSLCB).
      • Tonani felt this hadn’t mattered given how SB 5367 had officials “cluster them all together.” Moreover, as labs were “HPLC driven” there was some distinction between what they could detect, and what would be “safe for humans.” Douglass agreed what labs could “reliably detect” mattered, especially “when defining what ‘any detectable amount’ is.” Nordhorn was supportive of this approach, as it could lead to an understandable threshold of what could be reliably detected.
      • Sams brought up how the Association of Official Agricultural Chemists (AOAC) had released a “validated method that is well characterized based upon HPLC with UV detection” which he said was “suitable for determining…18 or so different cannabinoids in plant material and other matrices,” representing a “good starting point.”
    • As the discussion wound down, Nordhorn commented that WSLCB officials were seeking a "reasonable application of law" along with being “focused right now on regulatory approaches and matters.” He acknowledged, “when local law enforcement gets involved they have criminal standards to be looking at, and so it's going to go to a completely different lab.” This led him to think, “we need to figure out how we bridge some of that conversation with our crime and tox[icology] labs as well as our regulatory…labs” such as WSDA (audio - 3m, Video - WSLCB).

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