WSLCB - Focus Group - SB 5367 Implementation
(December 15, 2023)

Here are some observations from the Friday December 15th Washington State Liquor and Cannabis Board (WSLCB) focus group on the SB 5367 Implementation rulemaking project.

My top 3 takeaways:

• Staff laid out the basics of SB 5367, agency request legislation relating to tetrahydrocannabinol (THC) regulation, and what kind of input they were looking for in the implementation rulemaking project.
  • Passed on May 9th, the final bill report indicated the statutory effects which covered new and amended definitions; product additives and labels; and violations for selling hemp consumable items with “detectable” amounts of THC. Board members voted to start the rulemaking project on June 21st.
  • In the focus group, Policy and Rules Manager Cassidy West cautioned she was “a little under the weather,” and thanked attendees for their patience. She stated that officials continued “trying to align the current rules…with the language in 5367,” and were especially looking into “decision points, or things that we need to know in order to be able to finish the set of conceptual draft rules.” West expected to propose rules “at the end of January or February” (audio - 5m).
    • She shared a handout covering the discussion topics which would guide the conversations, adding that while feedback and ideas were encouraged, “we're not committing to putting them in the proposed draft rules.”
    • West explained that as officials worked “to make whatever changes are necessary to be able to implement the provisions” of SB 5367, they welcomed all feedback, especially responses “paying specific attention to…factors like benefits; cost; indirect and direct impacts; laboratory and/or testing considerations if possible; unintended consequences.” For some topics, she prepared several options for participants to consider so WSLCB staff could “see if there's one that's preferred or if anybody has additional suggestions.”
  • West described how the questions raised in their materials came from WSLCB representatives. Staff were “working with other folks at other agencies like Department of Health [DOH] and Department of Agriculture [WSDA],” since the former managed the medical cannabis program, and “WSDA [was] working on rules for lab standards,” she said. West indicated there had been “a lot of thought, this is how we came to…what we need to do, and [what] we don't know” (audio - 1m).
    • Find out more from WSLCB and Washington State Department of Ecology (DOE) leaders’ remarks to a legislative committee on December 12th. Also, WSLCB leaders talked about WSDA interest in becoming the lead agency on accreditation of cannabis testing laboratories on December 14th.

• The bulk of the discussion centered on several potential definitions related to THC concentration developed by agency staff.
  • West introduced the subject, stating “delta-9 is the only THC that's required to be tested right now for potency testing,” but SB 5367 mandated that the definition in law be “expanded to include other forms of THC.” Offering delta-8-THC as an example, she said if it was naturally occurring “that would be…included in THC now, where it was just delta-9 before.” West and staff wanted to ascertain whether other cannabinoids should be included as part of THC content, “and if so, which cannabinoids?” (audio - 3m)
    • West mentioned there was some interest among officials of not trying to identify synthetic cannabinoids—“which are more explicitly banned now in law”—but rather use high levels of cannabinoids not known to naturally occur at those levels as “indicators” that products may contain synthetic compounds.
    • The law had a concept of “total THC” which had previously only been delta-9-THC, but West noted “if we do include or require additional cannabinoids in potency testing, then how does that change the definition of total THC?” When she’d looked at testing policies in other legal cannabis states she’d found “most predominantly they were testing for delta-8,” along with cannabigerol (CBG) and cannabinol (CBN).
  • Jessica Tonani, Verda Bio CEO, spoke up to say that “it's really important that we make sure that the labs are able to test whatever becomes on this list, and that it is inclusive and there's some math behind it.” West responded that WSLCB would work with WSDA counterparts on this, adding some of the department’s staff were in attendance (audio - 1m).
  • Turning to a definition for “active THC,” West conveyed that officials were at “a fork in the road” for defining the concept. She was concerned “with the new definition of THC concentration” including compounds besides delta-9-THC, that “however we end up potentially changing” THC calculations for total and active THC remain understandable for regulators and stakeholders (audio - 5m).
    • “I think we all know…what the definition is of active THC without…it being defined in rule,” West asserted, saying it was THC “after it's been decarboxylated.” She asked if anyone wanted that defined further, wary of using a term in rule “especially when…there's not a clear dictionary definition for things.”
    • With no one offering initial comments on active THC, West emphasized that the definition would impact how accredited labs conducted product testing. She wanted to “have clear guidance on what we're looking for when they report stuff,” such as “how are we requiring labs to do the total THC calculation, and how do we then from there put whatever results on the product package?”
  • Scott Waller, Washington Association on Substance Misuse and Violence Prevention (WASAVP) Member and Former Washington Traffic Safety Commission (WTSC) Tribal Liaison, remarked that he’d been “doing a little bit of research" and found delta-8-THC, CBG, and CBN could be naturally occurring in the plant, whereas “to me active THC [was] those plants that can cause an impairing effect that occur naturally…in the plant, or that can be…synthesized to do that.” He was trying to better understand the “complicating factor” (audio - 4m).
    • Tonani noted that THC acid (THCa), an “un-decarboxylated THC,” could be helpful to include for those using cannabis for “medical purposes and different things like that.” The question for Tonani was whether it was “worthwhile to have…what's already decarboxylated differentiated from what's not decarboxylated on a label.” She advised that “total THC potential [was] obviously like, THC plus 0.87 times THCa.” However, she saw there were “places that, that potentially differentiating what is already decarboxylated versus not decarboxylated may have some justification.”
    • West showed three definitions for “total THC” staff were considering incorporating into rule:
      • Not amending current rule and continuing to only use delta-9-THC when calculating total THC
      • Amending the calculation with a formula to include cannabinoids besides delta-9-THC
      • Having separate total THC calculations for each type of cannabinoid detected.
    • West also indicated they could eschew using the term total THC and “completely replace it with THC concentration” in rule, something which would still require updating packaging and certificate of analysis (COA) reporting.
  • Medicine Creek AnalyticsScience Director Amber Wise wondered if delta-8-THC content was regarded as synthetic. West assured her WSLCB would investigate elevated delta-8-THC levels to see if they were created through synthesis, or "if someone did some crazy selective breeding" which caused higher naturally-occurring levels of the substance (audio - 3m).
    • Tonani indicated there had been previous discussions about a threshold below which a cannabinoid’s presence would be disregarded. West remained open to the approach, but added “it gets tricky to put numbers in rules,” suggesting that the WSLCB Cannabinoid Science Work Group (CSWG)—which included Tonani—might have some insights. Wise felt that anyone with a COA showing cannabis plants with high levels of delta-8-THC could use the extracted cannabinoids in a processed product “because the labs can't tell the difference between natural and synthetic.”
    • Companies have advertised delta-8 seeds and strains as producing plants with higher levels of the cannabinoids, however many sites advertising delta-8 flower acknowledge their products were infused or sprayed with chemically converted hemp cannabinoids.
  • Dave Michaelsen, WSDA Cannabis Lab Accreditation Standards Program (CLASP) Coordinator, stated “this is not just identifying issues with the plant itself but issues that also come in some of the products that [processors] are creating and…their ability to spike a product with some type of synthetic cannabinoids.” He remarked that SB 5367 had come about after regulators found cannabinoid content in non-cannabis products made from hemp. Michaelsen knew labs could test for some cannabinoids besides delta-9-THC, though he wasn’t certain “whether they're doing it on the [Initiative]-502 products or not.” However, “we do see that there is the availability of spiking samples or products with some of these extra THCs,” leading him to be troubled by the “ability to use other THC in products that are not currently controlled” (audio - 10m).
    • Tonani saw comments from both Michaelsen and Wise as indicating “if somebody's forced to show a plant COA, if…a small percentage of the total cannabinoids [were] delta-8 or something like that in a plant material you would expect that to carry forward, you know versus all of a sudden having the majority of the cannabinoid be delta-8.” Michaelsen agreed that regulators didn’t expect to see that “in the immediate future, not that that can't change.” He said there hadn’t been “focused rules and so now since we see that it's happening out there in the industry that we need to focus the rules to be able to identify those situations as they come up.”
    • West believed an implication of a definition of active or total THC would be when determining the maximum amount of 100 milligrams (mg) per package. She said a policy statement previously issued by the board “basically said that any THC found in the plant…cannot exceed that 100 milligram limit,” encouraging attendees “to consider that as well.”
      • The agency policy statement on “THC compounds other than delta-9 and the conversion of CBD, hemp, or both to delta- 8 THC, delta-9 THC, or any other cannabis compound” was withdrawn on August 16th.
    • Wise mentioned some of the issues Michaelsen raised were addressed in recommendations from the Washington State Hemp in Food Task Force, of which she’d been a member. The recommendations indicated officials should not “make a list of molecules that are allowed or not allowed…you simply allow certain types of extraction and conversion to be allowed.” Permitting no extraction “unless it's light heat or pressure” should “remove all of the issues of that we're talking about…if you're just allowing solvent extraction and then not any other conversion after that aside from essentially decarboxylation or processes that don't have any type of solvent involved, that pretty much takes care of this.”
    • West concurred with the “benefits…about being more broad in language” as she felt that could “account for future innovation.” She welcomed any ideas for wording that rule, and promised to review task force meetings.
    • Wise replied that she was in favor of having a set number for what was considered detectable THC, “but in terms of deciding what molecules to include or not include that was the conversation I was trying to address.” She added that “if the State decides to name other molecules that are not delta-9 that becomes very complicated what to include, what not to include, what's possible today, what's possible a year from now, but when you simply allow natural extraction only and no synthetic conversions after that, then you don't have to have that conversation nearly as much…we're only limited to essentially what the plant can make and some decarbing after that.” Overall, Wise argued “it simplifies a lot of the guesswork of what can people do in the future in terms of molecular formation.”
    • Tonani readily agreed, “it narrows the list substantially and it, it makes it a lot easier…overall, especially since we say these synthetic compounds aren't allowed.”
  • Waller called it an “interesting conversation,” but claimed 0.3mg of THC was specified in law, so “we need to…keep in mind that there [was] a number associated with this and at some point there needs to be a standard that the labs are, are actually testing toward” (audio - 4m).
    • Tonani believed that the number Waller referred to was in federal law, but under SB 5367 the State had declared “there's a non-detectable limit which is what I believe the LCB is trying to tackle here.” She explained that the CSWG had advised on defining detectability based on a limit of quantitation (LOQ) in rule that could be reliably determined by a lab, since “zero’s not necessarily a number that they can test to.” This had led the work group to set a limit of detection (LOD) of 0.[0]3%,” commented Tonani. She elaborated that the CSWG “also went through a fairly sizable amount of data that different groups had presented on what they believe the chemistry can detect using different matrixes and, and that 0.03 was kind of a number that came up in the majority of publications we evaluated.” She likened the standard to telling people “don't drive too fast without setting a speed limit and we have to figure out what the appropriate speed limit is that the labs can actually detect.”
    • West added an option to their working document amend existing rule language to add “a limit of quantification to just reflect the LOD associated” with a product COA.
  • “The bill expanded the definition of cannabis products to include products containing a detectable amount of THC,” West said. Besides the CSWG recommendations, she mentioned staff had heard from people advising “amending the limit of detection to be lower than [0.]03%,” or “not including a limit at all, and referencing third-party standards” (audio - 3m).
    • Michaelsen had found that among Washington accredited labs, “many of them were already using an LOD of 0.03% and it doesn't seem to be…ridiculous.” He understood that “over time, 0.03 seems to be fairly consistent - something that they can achieve realistically” and reflected “what we’re seeing in real life.”
    • West added that the CSWG suggested developing different limits for testing different product types which could be “refined” in the future "based on whatever evidence we get."

• The conversation then moved to defining synthetic cannabinoids, as well as packaging and labeling changes which would result from the new and revised definitions.
  • West established that synthetic cannabinoids were expressly banned in SB 5367 for both cannabis products “for the purpose of enhancing it’s CBD concentration…also with regards to synthetic, a new section was created that explicitly…prohibits the producing, processing” or sale of “synthetically derived, or completely synthetic cannabinoids” (audio - 1m).
  • Tonani returned to Wise’s point that it could be preferable to regulate processes instead of the molecules. When West called the dictionary description of synthetic “pretty good,” Tonani cautioned that it was “a little bit circular,” and indicated that regulators in New York had “accidentally” banned decarboxylation by “using a definition like that because…most people decarboxylate…especially in the edible market.” West again asked anyone with suggested language to send it to agency staff, reasoning that they could use a dictionary definition so long as an exception for decarboxylation was added. Tonani promised to look into the Hemp in Food Task Force findings “just around trying to kind of clean up and prevent some of the synthetics” (audio - 5m).
    • Via chat, Daniel Sondheim stated: “Oregon has some langu[a]ge on artificially derived cannabinoids.”
  • West moved on to the labeling and packaging changes which could be made to support new or revised definitions. “The statute created a new definition for ‘package’ and ‘unit,’” the latter of which was already in rule, she noted, “and so we would be replacing…the current rule definition with the new statutory definition of ‘unit’”  (audio - 5m).
    • West continued, saying terms “container” and “package” were in rule, but only “package” was used in statutes. She said there were “issues” with this arrangement, and she commented officials would have “to define inner package and outer package.” West promised to follow up by posting “which sections would be affected” online.
    • Referring to the definition of “unit” which had centered on serving sizes, West asked if there were changes, or reasons to maintain a definitional emphasis on serving sizes. No attendees had feedback on the matter (audio - 2m).
  • West encouraged participants to email written suggestions to her team, assuring people materials would be added to the WSLCB laws and rules page. She indicated responses would be welcomed until the end of the year.
    • Although the laws and rules page reported “informal public comment period deadline [was] on January 10, 2024 at midnight,” West’s table of draft changes had not been posted at time of publication. 
  • West scheduled additional focus groups to discuss SB 5367 on December 19th and 21st to incorporate more feedback ahead of publishing conceptual draft rules early in 2024.
    • On December 5th, West told WSLCB leaders she planned to convene a second round “of stakeholder engagement probably in early January,” but didn’t specify if this would be before, or after publishing conceptual draft rules.