WSLCB - Listen and Learn Forum - HB 2826 Implementation
(September 29, 2020)

Tuesday September 29, 2020 2:00 PM - 4:00 PM Observed

For this session, we are discussing only draft conceptual rule sections 314-55-550 to implement House Bill 2826 pertaining to marijuana vapor products, and the Marijuana Vapor Product Disclosure Form.

WSLCB Announcement

Engagement Options

Phone

Number: +1.415.655.0001
Access Code: 372 115 47

Observations

More than 60 participants attended the forum on the implementation of HB 2826 but few shared comments on draft conceptual rules and a proposed Marijuana Vapor Product Disclosure Form.

  • Looking at the conceptual rules for a new section on “Marijuana vapor products,” agency staff heard a suggestion to define ‘public health’ and a question on the agency's power to regulate vapor device use in addition to sales (audio - 6m).
  • When considering the draft product disclosure form developed by WSLCB and the Washington State Department of Health (DOH), cannabis industry representatives questioned if the form was applicable to all concentrates or only vapor products and how frequently disclosure would be expected (audio - 3m). Participants also voiced concerns over when terpenes would be defined as an additive and wanted clearer public disclosure exemptions on ingredient suppliers and proprietary information.
  • Prevention community advocates spoke up to ask about vapor device research and the timeline for submitting suggested revisions.

The second forum on WSLCB’s new authorities granted in the wake of the VALI health scare revealed a “balancing act” between public health concerns and business viability.

Here are some observations from the Tuesday September 29th Washington State Liquor and Cannabis Board (WSLCB) Listen and Learn Forum on the implementation of HB 2826.

My top 3 takeaways:

  • Policy and Rules Coordinator Casey Schaufler welcomed attendees, reviewed the meeting format, and described the background of the bill and rulemaking process.
    • HB 2826 Implementation (Rulemaking Project) was agency request legislation from WSLCB passed earlier this year banning “all non-natural flavored marijuana vapor products and requir[ing] processors to disclose what ingredients are in the products.” The legislation was part of the State’s response to the vapor associated lung injuries (VALI) health scare which occurred the previous fall. 
      • See the rulemaking project’s first first listen and learn session on September 1st for background and public input on the definitions of ‘terpenes’ and ‘characterizing flavors’.
    • The second listen and learn WebEx drew more than 60 attendees of whom Cannabis Observer identified 11 individuals who provided input or listened in via phone (audio - 5m).
      • During phone-in participant introductions, we encountered technical difficulties creating a gap in the recording including the introduction of two call-in participants, and callers who didn’t respond to Schaufler.
      • WSLCB Policy and Rules team
        • Kathy Hoffman, Policy and Rules Manager
        • Casey Schaufler, Policy and Rules Coordinator
        • Audrey Vasek, Policy and Rules Coordinator
      • Remote participants and observers
    • Following participant introductions in the webinar chat box, Schaufler provided an overview of the forum guidelines (audio - 2m) and the rulemaking process, highlighting that the project was at the “pre-proposal statement of inquiry” stage with conceptual draft rules. He added that the draft disclosure form was developed in conjunction with the Washington State Department of Health (DOH) whose staff would be tasked with doing something with the forms (audio - 6m).
      • When HB 2826 was signed into law on March 25th, Cannabis Observer noted a final fiscal note had been submitted for the bill on March 16th - after the close of the legislative session on March 12th. In it, DOH claimed no expense would be incurred because “The bill as written requires the Liquor and Cannabis Board to adopt rules requiring processors to submit a complete list to the Department of Health (DOH) of substances contained in their marijuana vapor products, however, the bill does not instruct DOH to store nor process the information, therefore there is no fiscal impact.”
  • A few participants weighed in on draft rules for the regulation of cannabis vapor products mostly to suggest definitional changes, but also voicing concerns about the agency’s new power to regulate vapor device use.
    • WAC 314-55-550 - Marijuana Vapor Products (audio - 2m).
    • Kelsey Holstrom (audio - 3m).
      • Holstrom was concerned about “vagueness” in the wording of subsection (2)(b) regarding “determining the reliability of a source” for concentrate ingredients. Holstrom asserted that “science concerning inhaled additives is still new and it’s changing all the time” so emerging studies could potentially “be presented as conclusive.” Instead, she advised editing the subsection’s phrasing on validity to read “other information from peer-reviewed scientific literature confirmed to be reliable” by the DOH.
      • On subsection (2)(d) and (e) “regarding the list of prohibited substances,” Holstrom asked if the disclosure form would change “every year” and whether “changes to the list” would include “public comment and stakeholder input.”
      • Lastly, she wondered “how are the changes to the list implemented in terms of compliance and how long will producer/processors be given to make potentially large changes to their processes and their packaging?”
    • Lukas Hunter (audio - 2m).
      • Hunter found Section (1) on the purpose of the rule to be “duplicative of what’s already in RCW [69.50.101(xx), RCW 69.50.342(1)(m) and (n)]” and asked for “the general removal of it since it already is stated in statute.”
      • Additionally, he noted the “general lack of definition behind ‘public health’” and asked about adding a definition in WAC 314-55-010. Hunter said he’d submit a definition to agency staff by email.
    • Jim MacRae (audio - 6m).
      • MacRae said that WSLCB was “bringing on the authority to regulate [vapor] devices potentially in the future” in sections (1) and (2). He wanted to know if the agency had “any awareness of any issues that have arisen specific to devices [inaudible] and if so, I’m asking the question of whether” agency staff felt the device language was “necessary.” Schaufler was uncertain “that was something we can answer here today” and referred MacRae to the language of the session law. MacRae commented that he was doubtful WSLCB needed “the section on devices in there. I’ve seen nothing in the market that indicates there would be a need for that.”
        • Section 3(m) of the session law granted WSLCB authority to prohibit “any type of device used in conjunction with a marijuana vapor product” upon determination in consultation with DOH (“or any other authority the board deems appropriate”) that the device “may pose a risk to public health or youth access.” So even if there is no overt or purported public safety/health concern, the Board may take action to ban specific devices from the regulated marketplace if it may risk "youth access,” a new term added to the fundamental definitions in Washington’s Uniform Controlled Substances Act as part of this bill: “the level of interest persons under the age of twenty-one may have in a vapor product, as well as the degree to which the product is available or appealing to such persons, and the likelihood of initiation, use, or addiction by adolescents and young adults.”
      • MacRae argued that the agency’s new powers to prohibit vapor device “use” went beyond the WSLCB’s authority to regulate licensed businesses.
    • Hailey Croci (audio - 2m).
      • Croci asked about the rulemaking comment period.
  • Participants wanted to know about disclosure of trade secrets, duplicative forms, and the State’s role in safety research of vapor devices.
    • Marijuana Vapor Product Ingredient Disclosure Form (draft, audio - 1m).
    • Lukas Hunter (audio - 3m, audio - 4m).
      • Hunter voiced his lingering uncertainty over whether the form would be limited to processors creating concentrates for vapor products only. Acknowledging the form’s title of ‘Marijuana Vapor Product Ingredient Disclosure’ he noted that the proposed WAC 314-55-1055 was “applicable to all marijuana concentrates.” Instead, he advised changing the draft document’s “marijuana vapor product to a marijuana concentrate for inhalation.
      • With the form “moving over to [DOH],” Hunter asked “how will it be kept exempt from public records requests?” He noted “processors are putting down very sensitive information about their intellectual property” and felt it was important to “[prevent] that from just being open to whomever.” He called attention to the “amount of the constituents” as a specific concern, and wanted assurance that “this will be kept with some level of confidentiality - or is the act of disclosing this to [DOH] also disclosing it to whomever wishes to look at this?” Hunter promised to submit a revised version of the form to the agency.
      • Hunter noted “this form has to be filled out quite a few times” as every “batch of marijuana we have to list a new source for the marijuana.” Harmony Farms sometimes sourced cannabis distillate from other companies for their vapor concentrates, and filling out a form for every batch made would “create a lot of redundancy within this form...fundamentally, the only thing that’s changed in that, is the source of the product. Well, the source of that product is already tracked through the Washington state traceability system.” In the event of a product recall, Hunter reasoned that traceability was sufficient, adding that his company was “up to about 320 submissions” to WSLCB already. For this reason, he recommended “the source of the cannabis that is going into the product” be removed from disclosure.
    • Kelsey Holstrom (audio - 3m).
      • Looking at the form’s third question, Holstrom said that α-Bisabolol was listed as a thickener but “was also a common terpene” and asked how the agency was “determining which terpenes are considered” thickening agents, in particular α-Bisabolol.
      • For the fourth and fifth questions on the form, she suggested that they were “at least partially redundant.” She asserted question four inquired if “you flavor your vapor products with terpenes derived solely from marijuana or from hemp or from another biological source? And then question five reads ‘do you flavor your vapor product with botanically-derived terpenes?’ In my mind ‘botanically-derived’ is the same as from a biological source.”
      • In reference to the first question in the form’s section on Additives currently prohibited (“Do you flavor your vapor products with synthetic terpenes or essential oils?”), Holstrom noted the agency mentioned essential oils under the definition of lawful botanical terpenes. “So, to me it doesn’t appear accurate to disclose them” as prohibited additives, she stated.
    • Crystal Oliver (audio - 1m, audio - 2m).
      • Oliver echoed worry over what trade secrets cannabis businesses would be disclosing, specifically around sourcing.
      • She also suggested the possibility of a separate form for product cartridges or vape devices which licensees would update anytime they were “using a new kind of hardware.”
      • She joined in the call for “clarification on when this form is to be submitted and...how often it should be submitted.” Representing outdoor cannabis growers, Oliver noted that many of her members “never use any additives but the communication they’ve received from the LCB is that they’d need to submit one of these for each strain...that they use for a product and that just seems very cumbersome and excessive especially when you’re talking about someone who isn’t even using additives.”
    • Jamie Shipman (audio - 1m).
      • Shipman asked whether the forms would be “something that retail stores can get for every farm.” Particularly for medical patients asking about concentrates as the forms would have more information than was “provided in the analytics currently.”
    • Hailey Croci (audio - 2m).
      • Croci asked whether the device section of the disclosure form “call[s] for any information on the heating elements that are being used? So, are they coils that are coming into direct contact with those, are they ceramic heaters...and what are the testing methods for those devices?” Croci suggested that “depending on the heating range of any of those particular devices, how that will interact with the substances that they are coming into contact with?”
        • The same day as the forum, University of California, Irvine (UCI) Strategic Communications & Public Affairs drew attention to a preliminary study published earlier in the month wherein “researchers observed [electronic cigarette] eC or vaping product use-associated lung injury (EVALI) immediately after switching from a vaping device with a stainless steel heating element, to one that used nickel-chromium alloy (NC)” at high power.
    • Jim MacRae (audio - 4m).
      • MacRae offered “one comment on this concern that’s coming up about the proprietary nature of distributors...it is conceivable that a given ingredient could be bad from one supplier and not from others.” This meant that “knowing the source of a supplier for purposes of ultimately being able to efficiently target and execute recalls” was a valid justification for tracking ingredient sourcing. MacRae asked that “perception of proprietariness” be in balance “with the potential implications on consumer safety.” 
    • Wrapping up, agency staff spoke to themes they’d observed.
      • Schaufler said he’d heard a need to address definitional vagueness and find a balance between consumer safety and trade secrets (audio - 2m). 
      • Hoffman concurred that public health needs and business protection for licensees would be a ”balancing act” that WSLCB “will need to look into” (audio - 1m).
    • Schaufler closed out the session and went over next steps for the rulemaking project. He said staff would organize comments from both listen and learn events “as well as written or otherwise received public comment” and review them with DOH staff (audio - 4m).
      • The agencies' representatives would “try to make updates where it's applicable,” potentially redrafting the rules. Schaufler expected the CR-102 containing proposed rules would be ready “sometime in December.” Depending on public comment, staff might consider another listen and learn event.
      • Schaufler revealed that the draft rules and form had been previously shared with other state agencies in Washington and the Oregon Liquor Control Commission (OLCC) “just to get some feedback and expertise on these forms as well as some of our licensee/stakeholders that have seen this prior to this meeting.”
      • Hoffman and Schaufler thanked participants for their “continued interest” and “strong approach.” Schaufler said public input on the conceptual draft rules and form was still welcome. He encouraged participants to sign up to receive email updates from WSLCB.

Information Set