Members reviewed already-submitted edits and suggested final changes to WSLCB recommendations on THC detectability, lab technology, product safety, and future topics.
Here are some observations from the Thursday October 5th Washington State Liquor and Cannabis Board Cannabinoid Science Work Group (WSLCB - Work Group - Cannabinoid Science) Public Meeting.
My top 3 takeaways:
- Research Manager Kathy Hoffman briefed on subgroup meetings which had informed decisions about what to recommend to board members (audio - 2m, Video - WSLCB).
- The group most recently gathered on August 3rd, where WSLCB staff planned more subgroup activity and announced an intention to continue hosting the work group even after they submitted recommendations to the board.
- Hoffman informed them that recommendations had begun to be drafted in between subgroup meetings, stating it had taken a lot “to get us to the point that we could discuss these draft recommendations and finalize them.”
- August 22nd - Detectable Levels of Tetrahydrocannabinol (THC) and Future Standards Subgroup
- August 24th - Cannabis Product Safety Guidance Subgroup
- Hoffman explained that members agreed to combine both subgroups—whose meetings had been closed to the public—”because there was so much crossover in the subject matter.”
- Agency staff then went over the draft recommendations, as well as what they thought would need to be addressed in the future as members provided editorial feedback.
- Hoffman started off by making clear that work group members had seen the draft and provided some responses so they could all “review a draft, provide feedback, and we're going to discuss the feedback on the recommendation portion.” She set out several changes and plans for supplemental information which was being drafted (audio - 3m, Video - WSLCB):
- In the executive summary, she said members identified “typographical errors.”
- Staff made “a minor adjustment” in the summary background, which covered “the history of how the cannabinoid science work group came to be, the structure of the cannabinoid science work group, and…what we did in terms of deciding how we're going to move forward with detectable levels and future standards and cannabis products safety guidance.”
- A survey of cannabis laboratories to ”find out what some of their processes were” led by officials at the Washington State Department of Agriculture (WSDA) was “still out and so we'll incorporate and consider the results of…that survey in the future.” Moreover, agency Enforcement and Education staff had gotten access to “information that they gleaned from [lab accreditation vendor] RJ Lee to determine cannabinoid LOD [limit of detection] and LOQ [limit of quantitation] values that will provide the agency with additional guidance.”
- Though members had been first to see the information, “we'll make it publicly available in the very near future as part of this report.”
- Tracy Klein, Washington State University (WSU) Vancouver Associate Professor and Center for Cannabis Policy, Research, and Outreach (WSU CCPRO) Assistant Director, inquired whether the WSDA survey had been sent out. While Hoffman wasn’t certain, Verda Bio CEO Jessica Tonani offered her understanding that “it went out earlier this week, but, but I don't believe it's…been tabulated or all the responses [were] back” (audio - 1m, Video - WSLCB).
- The first topic of the recommendations was “providing implementation pathways for any detectable amount of THC and to bring that into the work that LCB’s doing in terms of rule development” for SB 5367. She mentioned subgroup work to identify appropriate standards by the Association of Official Analytical Collaboration International (AOAC), ASTM International, and in the US Pharmacopeia (USP) Food Chemicals Codex. Hoffman explained that LOQ was “the lowest concentration of an analyte that can be measured by a method with acceptable precision and accuracy,” and LOD “refers to the lowest quantity of a substance that can be distinguished from the absence of that substance as with a stated confidence level… generally 99%” (audio - 1m, Video - WSLCB).
- Hoffman reported that they looked at “standard method performance requirements” (SMPRs) from AOAC (audio - 1m, Video - WSLCB ).
- Richard Sams, KCA Laboratories Scientific Director, provided further context that SMPRs represented the "goals for methods" of different product types and differing testing matrices, “but they all specify…an LOQ and an LOD.” Hoffman added that this reflected a subgroup focus on specifying different THC detection standards for different product types (audio - 1m,Video - WSLCB).
- Considering ASTM implementation pathways, Hoffman stated that Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry Brad Douglass had suggested edits “striking some language because there was a duplication of language here.” She invited work group members to “speak to the ASTM standards and how they differ from the AOAC standards” as the recommendation stated “ASTM looked at mass spectrometry…as the standard, where the AOAC standards looked at HPLC [high-performance liquid chromatography]” (audio - 3m, Video - WSLCB).
- Tonani shared that HPLC was the most commonly used equipment for cannabinoid testing in Washington labs, and was “used for cannabinoid quantitation” elsewhere. “For example, California recently did a pretty in-depth review of technology and, and did their standards based upon HPLC,” she remarked. Hoffman recognized one of the guiding principles in the subgroup was “what sort of recommendations can we make that aren't going to have a huge impact on labs in order to implement [SB] 5367, or at least write rules around 5367.”
- “Most of the ASTM standards are behind a paywall,” Hoffman observed, but “there is a piece of literature that references them Richard brought to our attention…but also again these were written primarily for mass spec” rather than HPLC.
- Douglass had also offered edits in the next section which Hoffman indicated would clean up some “clunky” wording. She said he’d also called for the recommendation to “explicitly denote the type of detector,” either “HPLC-UV [ultraviolet] or HPLC-PDA [photo diode array detector]” (audio - 2m, Video - WSLCB).
- Sams responded that he supported this revision, finding HPLC-PDA “refers specifically to a photo diode array detector, which is capable of recording absorption across a range of wavelengths and therefore it's a more specific term.”
- Hoffman commented they’d also “looked at the hemp seed protein monograph. It wasn't something that the group decided to go with” because they “really leaned into the AOAC standards to kind of guide our thinking.”
- “There was also the USP expert panel on medical cannabis flower that we took a look at and we didn't we didn't lean into that report at all,” Hoffman mentioned (audio - <1m, Video - WSLCB).
- Moving to the specific LOQ and LOD values they were going to recommend, Hoffman relayed that “the level of detection corresponding to this regulatory requirement [was] 0.03%.” She was open to feedback on striking or modifying how this was presented (audio - 2m, Video - WSLCB).
- Continuing on to “variances, detectable amounts of THC across product type,” Hoffman said recommendations reflected “the accumulation of…Richard's work,” inviting Sams to speak to what he’d learned (audio - 5m, Video - WSLCB).
- “I surveyed what [was] published both in peer-reviewed journals and in documents issued by organizations such as the AOAC and I looked at different methods,” Sams established. He reviewed the methods he’d found for different product matrices, along with a "minimum concentration of analyte that can be detected in the calibrators,” called a method detection limit (MDL), and a MDA, or "minimum detectable amount" that can be gauged by instrumentation. Sams believed the “major differences between methods revolve more around sample preparation, the mass of the material taken for analysis, the dilution factors that come into play, rather than the absolute sensitivity of detection of the instruments.” Additionally, he told the group the chart incorporated “methods that are used primarily by hemp testing laboratories and methods that are used by cannabis testing laboratories, and that's important because hemp testing laboratories often work [with] much lower analyte concentrations.”
- Tonani indicated that existing rules “specified that…cannabis testing labs have to be a little bit more stringent than some of these other labs since there [was] state-by-state regulation.” She suggested that “a number of those cannabis testing labs would not qualify under the State of Washington to be sensitive enough.” Sams concurred with this assumption, but for Hoffman “the conclusion here is that there is a range of limits… that the agency can consider.”
- Turning to product safety, Hoffman stated that the recommendations would offer definitions for several terms which were "really important to the subgroups," like “‘ingredient’, ‘processing’, ‘conversion’, ‘potency’, and ‘synthetic’, because these terms do not seem to be defined in statute or rule,” and “clarification to some of these terms might help in studying product specifications and manufacturing practices in the future” (audio - 1m, Video - WSLCB).
- Tonani stressed that "intermediate testing of hemp" being used as a cannabis product additive would be optimal as that would be more sensitive. She continued, “But the reality is without definition of some of these—processing, and conversion, and synthetics—it would be a giant loophole for people to use it as a potential ingredient and, and create impairing compounds downstream,” adding, “we really felt that these were important long-term for us to define.” David Gang, WSU CCPRO Director and WSU Institute of Biological Chemistry Professor, readily agreed, feeling that absent a set definition “it's possible for somebody to come up with an alternative definition and add in that loophole that [Tonani] was just talking about” (audio - 2m, Video - WSLCB).
- Nordhorn asked about “manufacturing,” which was defined in the State Controlled Substances Act, curious if there were specific edits the group would advise (audio - 2m, Video - WSLCB).
- We “saw some potential loopholes with processing and conversion in there,” said Tonani. Hoffman shared that there was “crossover” in wording used for manufacturing food products. Nordhorn responded that he understood they wanted to “clarify the manufacturing definition in statute to go further, to be more specific in this particular area.”
- Hoffman then discussed a section of recommendations devoted to potential future topics the work group members could offer input on, prefacing “the main concern was focused on what cannabis products [were] being consumed and that those products contain ingredients that are deemed to be safe” (audio - <1m, Video - WSLCB).
- Hoffman said Sams encouraged detailing how delta-8-THC “and its derivatives are semi-synthetic substances that are often contaminated with side products that are new chemical entities that have not yet been subjected to toxicological investigation” (audio - 1m, Video - WSLCB).
- Hoffman also raised the question of environmental implications from pesticide use brought up by Douglass. He felt it was worth exploring as “there's background contamination…in many agricultural products and many of these products are consumed in greater amounts in cannabis.” Hoffman said Sams shared that US Department of Agriculture “organic regulations allow…residues of prohibited pesticides in up to five percent of the EPA [Environmental Protection Administration] tolerance as long as the operator hasn't directly applied prohibited pesticides and has documented efforts to minimize exposure to them” (audio - 3m, Video - WSLCB).
- “If you're consuming ten milligrams in an edible…that's a fraction of a drop of water versus inhaling a joint [and] at the end of the day we may have different pesticide thresholds based upon the risk to the consumer,” explained Tonani. Gang agreed methods of consuming a compound were “very important.”
- “Another topic that came up was cannabis as a remediator,” commented Hoffman, noting “we've heard this in more places than just the cannabinoid science work group.” Finding out “how cannabis pulls compounds from soils in different ways” was a topic she wanted the group to study in the future. Hoffman asserted there were “a few just typos, word changes here. I don't think they substantively change the content or the thinking of the group, but does anyone from the work group want to speak to cannabis as a remediator?” (audio - 3m, Video - WSLCB)
- University of South Carolina School of Medicine Columbia Postdoctoral Fellow and researcher Taylor Carter, said he’d seen studies which led him to feel it was “definitely important just to keep track of [academic literature] with the ability of the plant to pull up so much of these, these metals, but also that there's ways to avoid some of these outcomes” of soil contamination.
- Tonani hoped State officials would continue to support research around “how the soil affects the actual flower material that people are making these products out of, and see if we could provide…guidance for producers” on safe cultivation practices.
- Gang felt there was also “variation” in how plants responded to different elements “in different environments” that would be relevant for studying remediation. “Not all heavy metals are identical,” he noted, and he viewed current research left "a lot of open questions still on how the plant is going to interact with different types of compounds."
- For the final discussion point on food safety, Hoffman gave Tonani the floor “because I think this was something you were very interested in and, and had a lot to share.” Tonani asserted, “depending on how much cannabis products somebody is consuming and how, we may have very different thresholds for what is safe.” She indicated that some compounds “that we have on our vegetables, our fruit,” were deemed dangerous in high amounts, but in “lower levels are…allowable.” Tonani said the subgroup discussed possible future regulations reflective of “how much cannabis somebody [was] consuming, and set threshold for safety around for these pesticides and heavy metals, based upon consumption and quantity of consumption” (audio - 3m, Video - WSLCB).
- Tonani added that pesticide “rules were set in the beginning by ourselves and done quickly…they could evolve in the future to allow...certain forms of remediation in oil, different thresholds based upon how somebody's going to consume the product, and really make sure that we keep safety in mind,” as well as “allow some tolerances if, if the products are still safe.”
- Gang was wary of any “recommended daily allowance” of pesticides or heavy metals in cannabis, but a "warning threshold" was worth considering. He compared this to warnings related to fish and seafood in different regions, and argued their aim should be to ascertain “what is that threshold for these different compounds. Having that information available in some way to people is going to be important, and figuring out the best way to make that available is something that we still need to do.”
- Hoffman started off by making clear that work group members had seen the draft and provided some responses so they could all “review a draft, provide feedback, and we're going to discuss the feedback on the recommendation portion.” She set out several changes and plans for supplemental information which was being drafted (audio - 3m, Video - WSLCB):
- After elaborating on some of the next steps for the recommendations and work group, Hoffman voiced gratitude in what was likely her last public event with WSLCB (audio - 2m, Video - WSLCB).
- Hoffman assured those present that the final version of their report would be publicly available on the agency website before thanking work group members, and surmising it was “gonna be nice to have a little bit of time back in your day.”
- She mentioned group members were scheduled to meet again on December 7th, though that was subject to change as staff would be returning from the Cannabis Regulators Association (CANNRA) annual member meeting in Nevada.
- Hoffman shared how she was “departing the agency as of October 15th. And so [Operational Research Specialist] Sarah Okey who's…part of the research program will be leading this work group after October 15th.” She said every member had conveyed to her their intention to continue involvement with the work group.
- Nordhorn thanked everyone for their time and contributions to the recommendations as he believed “this is really going to help the agency move forward and in some of the policy discussions that we're going to be having around this issue” (audio - 1m, Video - WSLCB).
- “It's been a pleasure to work with all of you,” Hoffman concluded, “I think we came up with a really meaningful, useful work product” (audio - 1m, Video - WSLCB).
- WSLCB staff previously announced their intention to schedule a public event on Monday October 16th related to dialogue on the implementation of SB 5367. However, no public announcement—nor mention of the proposed standards in the work group recommendations—had been released at time of publication.
Information Set
-
Announcement - v1 (Sep 27, 2023) [ Info ]
-
Agenda - v1 (Sep 26, 2023) [ Info ]
-
Report Concerning Detectable Levels of THC and Cannabis Product Safety - v1 (Sep 26, 2023) [ Info ]
-
Audio - Cannabis Observer (45m 30s) [ Info ]
-
Video - WSLCB [ Info ]
-
WSLCB - Work Group - Cannabinoid Science - Public Meeting - General Information
[ InfoSet ]
-
Announcement - v1 (Oct 3, 2022) [ Info ]
-
Charter - v1 (Sep 30, 2022) [ Info ]
-
Charter - v2 (Jan 6, 2023) [ Info ]
-