DOH - Webinar - Medical Cannabis - Workshop
(September 15, 2023) - Summary

2023-09-15 - DOH - Webinar - Medical Cannabis Workshop - Summary - Takeaways
[ Event Details ]

A mostly new team at the DOH Medical Cannabis Program solicited feedback on potential revisions to rules on compliant products, testing, labeling, and logos.

Here are some observations from the Friday September 15th Washington State Department of Health (DOH) webinar workshop on the medical cannabis rulemaking project.

My top 4 takeaways:

  • After the introduction of DOH staff, Medical Cannabis ProgramManager Loralei Walker provided some background for how department leaders approached cannabis products and compliance.
    • In February 2022, DOH staff hosted a public hearing to solicit feedback on updates to medical cannabis consultant certification rules. Medical cannabis rulemaking was filed by staff in December 2022, following a petition filed by John Kingsbury, Cannabis Alliance Patient Caucus Chair. The webinar had been set for August 29th before being rescheduled.
    • Walker shared that she’d been hired as Program Manager “in June, so I'm still pretty darn new.” She noted her past DOH work “as program manager for the Veterinary and Optometry Boards” gave her “quite a bit of experience in our processes and rulemaking” (audio - 1m).
    • Chemist Johnny Wong began working at DOH in July, but pointed to his experience in the “overall cannabis industry for about five years now, and working with CLASP [Cannabis Lab Accreditation Standards Program led by the Washington State Department of Agriculture (WSDA)] to determine the lab standards, and just learning more about the program, and more about medical cannabis in general in Washington” (audio - 1m).
    • Microbiologist Tholo “TJ” Johnson explained he joined the program at the same time as Wong, and previously worked at DOH “for almost a decade,” having “done a lot of…lab work” related to communicable illnesses. Johnson also assisted in “training new employees on…the assays that we run.” He also represented DOH on the CLASP team and declared, “I support the industry. I really support medical cannabis as well, I've got family history involvement with that, too. So, really happy…to be part of this group” (audio - 1m).
    • Annie Kause, Health Services Consultant, noted she worked “very closely with patients, [certified cannabis] consultants, and the general public” (audio - <1m).
    • Shannon Angell was the Deputy Director of Drug Systems, the DOH unit “that houses medical cannabis, and prior to that I was the program manager of medical cannabis.” She was eager for feedback, wanting “to see what we can do to this rule to just make it…a wonderful tribute to our patients, and to the cannabis industry” (audio - 1m).
    • Jeff Wise, Regulatory Analyst, told attendees while he lacked scientific expertise, “I'm a rule writer and bill drafter and have lots of experience in creating and…implementing legislation, and WACs.” He said he was “old enough to say that I was around when we were drafting” rules combining the unlicensed medical and licensed adult use cannabis sectors in 2016 and was attending to help program staff “craft language with you all” (audio - 1m).
    • Angell mentioned another Health Services Consultant, Reem Aldaghestani, had “been with the program, I think, the longest of all of us.” Aldaghestani worked with Kause on the “customer service line” and responding to emails, but “wasn't able to make it today,” said Angell (audio - 1m).
    • Walker reviewed some of the basics of the DOH rulemaking process, the “rules that govern our program, [and] the plan for this meeting.” She indicated that people could also reach her by email in order to join the email listserv for updates about the medical program (audio - 4m).
      • She described Revised Code of Washington (RCW) sections codifying DOH activities in law:
      • Medical cannabis was “very complex regulation that involves multiple Washington State government organizations and that often results in confusion,” Walker commented. She reported that the medical cannabis program team was part of the conversations on “regulatory improvements and market changes” between agencies in order to “have safe, reliable, and effective cannabis products for patients available on the shelves under the regulated market.”
  • Stakeholders posed questions to staff as they reviewed Marijuana Product Compliance rule subsections in Chapter 246-70 of the Washington Administrative Code (WAC) with potential amendments.
    • Walker brought up the CR-101 and working document, remarking how “the scope for this rulemaking is pretty broad” in order to include a “legislative change that is straightforward” as well as looking at “classifications of compliant products, the quality assurance/quality control pieces around the medical program, and aligning” with Washington State Liquor and Cannabis Board (WSLCB) codes where there were “pretty big rule changes in the last few years” (audio - 5m).
      • Talking about the “bread crumbs that…give the history of rule changes that were made, when they were made,” Walker noted, “none of these have been updated since 2016” and department staff would consider a variety of changes, including “for clarity and accuracy.”
      • Walker planned to review the working document “section by section” outlining changes. All sections would have the “terminology update” revising ‘marijuana’ mentions to ‘cannabis’ in alignment with 2022 legislation, or changes to “better characterize quality assurance.”
      • The findings section may have changes to the term ‘limited scientific data,’ with Walker mentioning they’d received feedback that “points to the bulk of [academic] work that we'll be looking at in these sections.”
      • Walker informed the group there was one subject area “we don't want to go in too deeply today…that has to do with tax exemption for sales and use tax. There was legislation passed in the Department of Revenue [DOR] statutes [in 2019] that…identified compliant products in WAC 246-70” which were “exempt from those taxes.” Walker said this meant DOH personnel had to “be able to differentiate what a compliant product means for the purposes of tax exemption at that point of sale, versus what we've been referring to as compliant product that complies with the regulations and requirements of this chapter.” This might mean adding ‘medical’ in order to “be more specific about what those compliant products are about,” she added.
      • Kingsbury—the only patient to testify at the commission hearing on the tax exemptions in 2021—picked up on the definition of what products qualified for the tax break, stating “when the legislature changed the language for taxes I was told by DOH that they…made a tortured…second definition of DOH product to preserve the status quo.” He wanted to know “why is DOH involved in tax policy at all?” (audio - 8m)
        • Walker replied that DOR “laws around tax exemption for sales and use tax said specifically that compliant product as defined in” DOH rule was at issue. Kingsbury asserted that changes to DOR statute in 2019 ensured the tax applied to compliant products; “and then DOH said ‘well, we're gonna make this memo to Department of Revenue to…nullify what the legislature did,’ I was told that by your agency.” He alleged this was communicated by then-DOH Office of Health Professions Director Martin Pittioni, and that he found it “disturbing” health officials were “establishing two definitions of compliant product in order to…nullify the legislature.”
        • Angell promised to learn more about the discussions between agencies and lawmakers related to the memo Kingsbury cited, but the policy was “defining that compliant product…as product purchased by a patient, and if it's a patient purchasing product that’s sales tax free.” However, Angell said they were hearing “that compliant product doesn't really identify” differences that made it a “medical grade product.” Walker said “our intent was not to dive deep into this discussion,” but she and Angell insisted they would take up the matter in future conversations.
        • Cannabis Alliance President Caitlein Ryan clarified that her understanding was “that move was being made to allow patients to have better access to receiving the sales tax exemption, but wasn't necessarily a part of the definition of medical grade product.” Walked suggested attendees “think of it as a rebranding…what we mean by compliant that meets the regulations for establishing…medically appropriate products.”
    • WAC 246-70-040 - Marijuana products compliant with this chapter (audio - 2m)
      • Angell described how staff were interested in building out the three established categories of compliant product: General use, high tetrahydrocannabinol (THC), and high cannabidiol (CBD). She said that DOH officials had heard “the categories haven't actually been as helpful as maybe having more focus around what makes that product safer, what testing criteria allows for more safety and better product for medical use.” Angell welcomed input on terminology, use of categories, or “why the product [had] a higher standard than recreational product.”
      • Wendy Hull, Fairwinds CEO, relayed that her company manufactured medically compliant products since 2016 or “early 2017” (audio - 2m).
        • She explained that Fairwinds had stopped making high THC products in part because they “ran into many roadblocks where the stores weren’t able to accept them into their system with the third party systems that were in place.” Hull said, “In terms of the CBD and the general use…we have some limitations that we've butted up against,” but she felt the rulemaking focus “really should be on what [did] DOH mean” when labeled on cannabis products, as opposed to their category titles.
        • “What [was] behind the DOH logo” had been “something that we've tried to educate” the public on through advertising, which Hull remarked was an “uphill challenge.” She understood “at one point we maybe had four companies” manufacturing medically compliant product, and suggested the market had further been impacted because “rules have changed around testing,” making it “even more confusing for some stores.” “Let's just focus on, not what those labels mean, but let's focus on the meaning behind the actual program,” argued Hull.
      • Ryan advised simplifying label language to “medical grade” could help patients and the public understand, adding, “medical grade is not a structure and function claim at all. It just lets people know that this is the grade of this cannabis” (audio - 1m).
      • Kingsbury’s impression was that the categories were “clumsy and problematic,” but they might be “there to meet some of the requirements in the law…that were put there in 2015” through passage of SB 5052. Angell agreed that high THC/CBD products were mentioned in statute  (audio - 1m).
      • Walker commented that staff would be looking at language changes and appreciated the feedback that existing terminology was “not helpful for a number of reasons and we should reconsider how we make these classifications based on the various standards that are going to be outlined and we’ll be talking about” (audio - 1m).
    • WAC 246-70-050 - Quality assurance testing (audio - 3m)
      • Acknowledging that adult use cannabis testing rules had been changed by WSLCB in March 2022, Angell stated, “since they now have a more robust pesticide requirement just for all product testing, it kind of nullifies the pesticide testing requirements that DOH compliant product had identified.” Beyond aligning with that testing standard, she said the “biggest…difference is we have a heavy metal testing piece that is required for DOH product. The other difference is the…actual time of when [testing was] required for DOH compliant product.” Angell encouraged input on testing requirements, wondering if there were new aspects like “additional pesticides or threshold limits that we want to impose...What does the terpene testing look like?” Moreover, staff may host a “separate workshop specific to this chapter,” she added.
      • Ryan told the group that Cannabis Alliance members “did do a significant amount of stakeholder feedback…with an eye towards encouraging more participation.” She said they’d talked to their producer and processor members, and their recommendations kept “an eye on cost, and this would reduce the cost from…what is currently in existence and hopefully simplify things” (audio - 1m).
      • Angell recognized that testing costs had been a top concern for stakeholders. Johnson shared after reaching out to laboratory staff and “talking to them about how we can better the industry, how we can help the medical side,” he’d been told additional required tests could “de-incentivize the producer/processors from making the product” (audio - 4m).
        • Jumping over to the idea of mandatory terpene testing, which Johnson was in favor of, he nonetheless feared “then maybe the two to three producer/processors that we have making medical grade stuff might opt out of it because of that additional cost.”
        • Johnson said that personnel at one lab were “hemming and hawing” about testing for Chlormequat chloride, alleging it was “kind of a pain only in that it resolves out very similar to other quaternary chloride.” He conveyed their interest in raising the action limit for Chlormequat chloride from 0.1 parts per million (ppm) to 0.5ppm.
        • Ryan referenced a table of costs developed by her group with input by lab staff at Medicine Creek Analytics and Confidence Analytics which quoted terpene testing costs between “25 to 30 dollars, maybe even as low as $15. So it's a pretty nominal amount added while reducing the costs in other areas.”
        • Wong specified that Chlormequat chloride was an active ingredient in “plant growth regulators,” rather than a pesticide, and “sufficiently different that it required an entirely different analytical step, and an extraction sub…it wouldn't be something that we could just add on to our routine pesticide screen.”
      • Johnson asked if end products could be tested, alleging “if we just did…testing for the end product” that could “drastically cut down how much these producers are paying for testing [and] how much the labs” charged. However, the feedback he’d gotten from lab staff and the industry was mixed, and some advised “we should look at…what the food industry does… testing products straight off of the shelf. I hesitate on that a bit more because I'd like to know that everything on the shelf more or less has been tested” (audio - 2m).
      • Kingsbury referenced the table of costs and said statute required that any DOH testing requirement would come in addition to WSLCB testing. He also believed “you can't just…get rid of LCB's protocols and the objective here was to align them more closely. And I believe what LCB did is they said the end product for concentrate has to be tested.” Kingsbury was in favor of testing concentrated items “because you never know what's going in that stuff,” and urged aligning DOH and WSLCB testing. He also wanted to let licensed producers decide whether a crop was sent “into the recreational market or the medical market, or ‘no, I changed my mind. I'm not going to go for that sticker’” as this would “be more seamless” (audio - 4m).
        • “Just adding stuff isn’t adding costs,” argued Kingsbury, but it depended on the weight requirements for testing lots. He was confident “the proposal that we have here [was] substantially less expensive, but actually adds a lot.”
        • Angell assured the group that staff were looking at creating similar comparison tables in order to “stay above and beyond” WSLCB requirements. She said “we do intend to work very closely with LCB and WSDA during this rulemaking process because we want to make sure that not only are we aligned, but that we are speaking a similar language in…how we're drafting these rules.”
      • Adding some “color commentary” regarding terpene testing, Ryan stated, “uniformly patients said that that would be extremely helpful information in helping them and their medical provider choose the correct product”  (audio - <1m).
        • Hull asked whether the request was for all terpenes, “botanical and cannabis-derived.” Ryan responded that it was framed more generally, “but yes, all terpenes [and the] top three or top five” terpenes present should be disclosed. Ryan relayed, “top terpenes can change even within the same cultivar depending on environment, and harvest, and all that good stuff” (audio - 1m).
      • Hull preferred to “test at the oil level just because it's more concentrated” leading to easier detection of contaminants that would be “diluted” in the final product (audio - 1m).
      • Johnson further felt terpene testing provided a separate “quality measure for the product outside of THC numbers.” He said high THC concentration products had been “driven by the market” and consumers. Retail budtenders would often frame products to consumers as sativas or indicas, but Johnson considered terpene test results to be one approach to demonstrating “what is this product like besides just that THC number” (audio - 2m).
        • Via chat, Cannabis Alliance Government Affairs Liaison Lara Kaminsky offered the view that “terpenes [were] much more indicative of an experience than THC amount and [was] much more useful information for all consumers.”
    • WAC 246-70-060 Compliant product labeling (audio - 1m)
      • Angell requested feedback on labeling that would assist patients, and differ from WSLCB labeling rules. “There's been discussion about a QR code in the past,” she noted.
      • Ryan didn’t feel any licensee wanted more required labeling, and consumers seeking the certificate of analysis could be "really nerve-wracking for a budtender.” She highlighted that because this could be so important for patients, “as the database project moves forward…perhaps that could be something” a QR code provided access to, not just the COA but…any other additional information about the product that could be medically useful for patients to have” (audio - 1m).
      • Kingsbury said, “A presence of neem oil or neem derivatives” had “been an issue with patients forever.” In speaking with lab representatives, he’d been told “they don't actually have a…way to test for that.” He felt voluntary transparency by producers using the items could be helpful “absent a testing requirement,” and urged DOH leaders to add in an “honor system” disclosure in rule (audio - 2m).
        • Johnson candidly didn’t “trust folks” to self-report neem oil usage, and alleged lab staff may have been saying they weren’t able to test for the substance since “it’s not required.” He commented that labs would need to procure a standard to test for Azadirachtin, a triterpenoid in neem oil, to test for the compound using “either probably a GCMS [gas chromatography–mass spectrometry instrument] or an LCMS [liquid chromatography–mass spectrometry instrument] in the lab.” Wong added that the matter was complicated by a lack “of info on health effects” related to the oil, moreover establishing “an action level will take some work, especially because we don't have any historical data because we're not currently testing for it.” Kingsbury reiterated that he was advocating for transparency, which was “huge when it comes to patient confidence in their product” (audio - 3m).
        • When Johnson asked whether attendees would trust producers to appropriately label use of neem oil, Kingsbury didn’t; “but based on my conversations, I felt like that was the best…that we could do.” If laboratory standards for neem oil existed, he was in favor of required testing. Ryan was also receptive to voluntary disclosure, and felt licensees “who do participate now and have participated in the past care deeply about making sure that they're providing products to folks…that are clean.” Hull also understood cannabis edibles were required to list “any kind of allergen” on packaging, such as “coconut or peanut,” wondering if DOH staff could draft a similar change. She was hopeful that “for the most part people would do the right thing” (audio - 3m).
        • Cannabis Observer Founder Gregory Foster was curious about whether GCMS or LCMS equipment would be required to detect neem oil, as not all labs had GCMS instruments. Wong answered that CLASP was planning to allow accreditation to standards that would allow either method to be used (audio - 1m).
          • In chat, Kaminsky inquired whether CLASP staff would “verify that validation.” Johnson replied: “CLASP would set the standard for testing requirements,” and could “allow for multiple different platforms so long as the quality measures for that method meet our standards.  If labs can show their method works within those confines, they can test with that platform.”
    • WAC 246-70-090 - Marijuana product compliant logos (audio - 2m)
      • As they re-evaluated product categories, Angell expected the logo for compliant products would be changed as well. She remarked, “we are definitely understanding that the logo needs a facelift” and hoped to hear advice because “it sounds like the logos are really what can make or break [a] consultant or budtender even showing a medical patient” a product. “What would we like to see that would be helpful to our consultants, and beneficial to our patients,” asked Angell.
      • Ryan suggested abiding by the industry version of the KISS design principle (“keep it simple, stoner”) and “if QR code is something that we're considering with additional information, folks now are pretty adept at going and getting the details.” She wanted a “simple demarcation that this product is different; and at a higher grade that you can trust and get more information on.” Ryan also felt one version of the “logo to rule them all” was preferable (audio - 1m).
      • Hull pointed out that rules limited ‘general use’ medical products to ten servings “regardless of the amount of THC in a specific serving, and that's been challenging to us because we have several products that are low THC.” She encouraged “lift[ing] that serving limitation” for general use products and “cap it by the amount of THC.” Hull argued “people were assuming that every product would have 10 milligrams of THC per serving and since that's not the case it's a limitation on quite a few of our products.” Angell replied that staff had heard similar comments from their WSLCB counterparts (audio - 2m).
      • Seconding Hull’s feedback, Kingsbury asked “whatever is on the label needs to…respect who the budtenders and the consumers,” and that rather than citing WACs “needs to speak to the consumer and…the budtender and it should have information that's useful to them with their knowledge base.” He considered even the term “compliant” to be unfamiliar in the context of cannabis to most adults. Angell agreed with the notion “the logo needs…to focus on the audience we're serving” (audio - 2m).
  • Department leaders went over future workshop topics and participants; and next steps for the rulemaking project.
    • “So we wanted to understand preferred approaches for upcoming workshops,” said Walker, identifying staff plans to group issues by “relationship…and how they relate to a…specific interested party/audience.” She then opened the floor to ideas on topics or approaches to workshops (audio - 5m).
      • Angell put forward the idea of “tailored workshops” based on topics “that were a little more expansive today…such as the tax compliant piece” and “quality assurance testing standards.” She was also amenable to stakeholder-specific sessions to hear from patients, labs, or licensees.
      • Kingsbury felt subject-areas were a good way to portion off discussions, but wanted events open as “that sort of pollination of different interests might serve well.”
      • Ryan felt any tax exemption conversation should not only be open to DOH stakeholders, but include representatives from the Washington State Legislature and DOR as well. “I think including all of the parties that might have been a part of that conversation—that was pretty opaque to the rest of us stakeholders at the time—will be really helpful.”
    • Hull added in chat, “i would love to see DOH educate Retailers and public on the program.  To date DOH has been pretty silent on the program.” Johnson responded positively, asking if she meant “educating them on the medical program…or maybe even on a grander scale” which he would like to see that includes “entourage effects, terpenes, and, and whatnot as opposed to just…indica, sativa, and THC numbers.” Hull encouraged this idea, reporting that licensed producers could be “limited on what we can say,” leaving businesses like hers “hamstrung on providing much education. But if information and education was coming from DOH that would certainly help us…any time we can get more information and education out there by a credible source,” it “helps all of us” (audio - 1m).
    • Through chat, Kaminsky inquired about “a conversation to be had regarding enforcement of these rules and the interplay between DOH and LCB?” Walker concurred it was “crucial” to coordinate between agencies, and with “our newly expanded team we have an opportunity to introduce ourselves [and] start building those relationships.” Kaminsky then noted her frustration that “you can write the best rules in the world, but unless they're enforced it doesn't really matter” (audio - 3m).
      • Walker recognized WSLCB Licensing Program Specialist for Label Approvals Susan Harrell had joined the discussion, and remained hopeful “we can get more LCB folks in on these conversations as well [in] future workshops.”
    • Johnson returned to the issue of dividing up future workshops, wondering if cannabis lab representatives were on the call, but none were present (audio - 1m).
    • Angell checked with DOH staff on whether “you feel like you've gotten a clear enough sense about how we can design workshops going forward.” Walker believed so, and felt staff could “roll out a plan of action for the rulemaking” (audio - 1m). Walker explained that after any follow up workshops, her team would begin “focusing on the draft language for our [CR-]102,” which she anticipated would be proposed “mid-November-ish” (audio - 1m).
  • Cannabis Observer Founder Gregory Foster brought up a recommendation by federal health officials to reschedule cannabis, and what that could mean for the State-level medical program (audio - 2m).
    • In October 2022, President Joe Biden requested a review of cannabis federal drug scheduling by US Health and Human Services (US HHS) Secretary Xavier Becerra and Attorney General Merrick Garland as part of a wider executive effort towards cannabis reform.
      • Approaches to changing the Controlled Substances Act (CSA) scheduling in Title 21 United States Code (USC) are either by act of Congress, or through Section 201 of the Act (21U.S.C. §811), which included “a mechanism for substances to be controlled (added to or transferred between schedules) or decontrolled (removed from control)...Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party” and “certain factors are required to be considered. These factors are listed in Section 201 (c):”
        • In making any finding…the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules:
          • (1) Its actual or relative potential for abuse.
          • (2) Scientific evidence of its pharmacological effect, if known.
          • (3) The state of current scientific knowledge regarding the drug or other substance.
          • (4) Its history and current pattern of abuse.
          • (5) The scope, duration, and significance of abuse.
          • (6) What, if any, risk there is to the public health.
          • (7) Its psychic [sic] or physiological dependence liability.
          • (8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.
      • As a US Senator from Delaware, Biden was among the fiercest proponents for the War on Drugs in the 1980s and 90s.
    • A longstanding Schedule I federally controlled substance, efforts to change the status of cannabis scheduling included a history of lengthy and unsuccessful petitions to evaluate the plant’s scheduling, most recently a 2011 petition from two governors, including then-Washington Governor Christine Gregoire which was denied in 2016.
    • In a July 27th hearing by the US House Judiciary Committee, DEA Administrator Anne Milgram told members she would seek a timeline from US HHS officials for their review. Just over a month later on August 29th, media outlets reported a leak that US HHS staff were advising rescheduling cannabis to Schedule III, which spokespeople for both US HHS and DEA confirmed as accurate, though the formal recommendation letter had never been publicly released before prior scheduling reviews were completed.
      • At time of publication the pharmaceutical version of THC (Marinol) was a schedule III substance, and CBD (Epidiolex) was descheduled in 2020 after being a schedule V substance.
    • Foster wondered if DOH staff had discussed the US HHS recommendation and how the medical program would be impacted were cannabis rescheduled at the federal level. Walker confirmed “we had a long discussion about that just a couple of days ago.”
    • Angell conveyed that staff were looking out for information or webinars on the topic, as the news was “still pretty fresh so we don't have a lot of details to go off of.” She said they planned to track developments, since “at DOH there's just a, a need for even a further review when a schedule shift happens for any type of drug or pharmaceutical,” and department staff would be “very, very involved in just making sure we have the information and then figuring out next steps.” Angell concluded they were interested to “see what happens in the near future.”

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