DOE - Webinar - Accreditation of Cannabis Laboratories - Public Workshop
(November 29, 2023) - Summary

2023-11-29 - DOE - Webinar - Accreditation of Cannabis Laboratories - Public Workshop - Summary - Takeaways
[ Event Details ]

Staff laid out changes in the latest lab accreditation rulemaking draft, including a lower cost of implementation and a waiver process around in-matrix proficiency testing.

Here are some observations from the Wednesday November 29th Washington State Department of Ecology (DOE) webinar workshop on the Accreditation of Cannabis Laboratories rulemaking project.

My top 4 takeaways:

  • Environmental Assessment Program (EAP) Business Operations Section Manager Alan Rue led an update on draft rule language, revised fees, and the timeline for implementation envisioned by DOE staff (audio - 7m).
    • Since staff had offered background on the topic and rulemaking process and reviewed changes in draft rules during previous workshops in August, Rue said staff “received feedback, made appropriate changes, and began our internal review process with our rules experts here at Ecology.” They were engaged in an “eight week economic review I mentioned in those summer meetings,” he remarked. Based on the feedback they’d received to improve the draft rule wording, Rue stated, “we believe we had the time and obligation to put a pause on our internal review and share with you all our revised draft rules…to make sure when our draft rule becomes our proposed rules we didn't have something unrecognizable to the public and regulated community.”
    • Rue went through some differences between the drafts, noting “we reworded our cannabis rules to be more clear to both the regulated community and the public.”
      • He highlighted “reformatting such as the replacing of bullet points in some places and non-numbered regulations with numbers, letters, and lowercase Roman numerals to match what's found in other rules across the agency” to help people more easily cite particular rules.
      • Rue said, “along with the rewording, some sections were also renamed more accurately to relay what they are intending to describe. A great example is the previously titled ‘accreditation categories’ was renamed to a more accurate ‘matrix groups.’ The term ‘matrix’ is more widely used and clarified in the rule, where the term ‘category’ is not.” 
      • He added that a few sections were reordered, then further noted “the registered status has been removed.” Envisioned as a “transitionary role as labs moved from the current accreditation system to this one,” Rue stated that while it was an approach “Ecology had in a previous version of the environmental WAC when we were bringing wastewater treatment facilities into our accreditation program,” he said staff “concluded that the registered status would not aid in the transition.” Without this status, he said another section was built out because staff “felt it was important to more clearly outline the actions…our accreditation staff are taking after the application is received.”
      • Rue commented that an “accreditation approval requirements section was removed because it was not providing any regulatory benefit,” as other sections served “the role in a more complete way.” Initial accreditation and renewal had been one section of the draft, but were split to make it “easier for us and clearer for the regulated community and public for them to be two separate sections,” he told the group.
      • Another new part was a standard operating procedure or “SOP section we added after the quality assurance manual,” Rue said. It was included when staff “pointed out that we had several sections within our rule where a reference was made to SOPs, and we didn't really have a clear explanation of what one was and what was required to be in it.” The SOP rule language would “give labs new to this space a clear set of expectations of how Ecology is going to process the applications.”
    • Turning to fees related to the accreditation process, Rue remarked that officials “wanted to try and find a way to address the feedback we received while still meeting our statutory directive” (audio - 4m).
      • “Initially, we read the…applicable RCW” as directing department staff “to collect fees only from accredited labs” to fully “cover the administrative and oversight costs of the cannabis lab accreditation program,” Rue said. Building out costs cannabis labs would need to cover led staff to project a “need to cover roughly $500,000 a year from the labs” for dedicated Ecology staff, he explained, along with some information technology (IT) costs for “application development, [and] database support for the unit.” Rue shared that “when divided by the eight existing labs, accreditation costs about $62,000 per lab, per year. We also lost a laboratory since we last met,” raising costs per lab even higher “than they are for environmental labs,” he noted. Rue suggested “legal barriers…limit the accreditation scope only to accredited cannabis laboratories within our state as opposed to the 450 or so labs across the US and Canada that are available in the environmental sector.”
      • “We reduced the program cost by reducing staff down to just one cannabis focused chemist,” Rue stated. He described how they would “share time…from other microbiologists on staff here at Ecology.” Changes resulted in a “roughly $670,000 cost for the program over a two-year span, with the overwhelming majority of that cost being the salary and benefits of an experienced chemist,” said Rue. The result was lowering the “cost for a lab to be roughly $48,000.”
      • “We needed to find a way to cover the gap between the start of the new biennium and the transition of accreditation to Ecology,” so Rue indicated staff had “changed the equation in the fees section to cover the cost for a biennium.” He then noted that they “cleaned up the definition of the letter ‘N,’ the variable, to be more clear what the number is, and what happens if there are no accredited labs.” Staff had also taken out a phase in period, Rue said, “since the RCW explicitly states: collect annual fees sufficient to cover the direct and indirect costs of implementing a state cannabis product testing laboratory accreditation program. A multi-year phase does not appear to be allowed.” He then reported that a decision was made to “move our fee start date back to July 1st of 2025…to both buy us time to get as many labs accredited as, as possible and lined up the fees to a biennium.”
    • The timeline for transfer of accreditation authority had changed based on the revisions to the rule draft, with Rue indicating that there would be one more workshop on December 7th. Staff would complete a final draft of the rule for a CR-102 in March of 2024, “and in April public hearings on the proposed rule.” He anticipated that a CR-103 adopting the rules could be done by the conclusion of May 2024 (audio - 2m).
  • Questions centered on in-matrix proficiency testing (PT) and waivers in the event an in-state PT supplier couldn’t be found, while other attendees asked about data recording, laboratory audits in 2024, and what literature on accreditation might look like.
    • Shannon Stevens, Confidence Analytics Laboratory Director, called attention to a lack of in-state PT standards, finding that “full accreditation, proficiency tests for potency, pesticides, and residual solvents must be in cannabis material containing concentrations of cannabinoids representative of products available to consumers. PT products described here are generally not available. How would we address this problem?" (audio - 3m)
      • Rue commented that in-matrix PTs were included “because that is what the Cannabis Science Task Force said we should do.” Draft rules now featured a “waiver process” through WSLCB that would exempt a lab from in-matrix PT requirements, he said. According to Rue, WSLCB would approve the waiver and it would then be submitted to DOE staff, who would perform a “qualified accreditation" of the lab in the absence of in-matrix PTs by using hemp matrix PTs. 
    • Cristi Crofton, Confidence Analytics Quality Manager, pointed to a language change in the draft related to incubator temperature recording, and specifically what equipment would be considered as conducting “electronic data recording” and how that differed from “data loggers” (audio - 3m).
      • Rue confirmed that data loggers were “any type of automated temperature recording device,” as regulators didn’t want lab staff to “put it on auto and…ignore it, you still have to go in and actually check those temperatures on a daily basis and, and make sure that…it's not getting off track” of tolerance levels for incubators.
    • Gregory Foster, Cannabis Observer Founder, recognized there were “currently no in-matrix PT providers licensed to handle and sell cannabis products in Washington state” and “there are a few options to either/or encourage an out-of-state provider to set up shop in Washington state, create a new WSLCB license type, or adapt an existing WSLCB license type.” He asked if staff had talked about the idea, or had a “preferred approach” (audio - 3m).
      • CLASP team members had begun having those conversations, Rue responded, though “that is something that WSLCB would have to handle, and we are fully in support of that approach moving forward.” He mentioned that WSLCB staff had begun contacting out-of-state PT providers, and regarded it as “a difficult issue and problem to solve but folks are working on it.” He added that they expected to have the waiver and qualified accreditation process “until such time that we…have in-matrix PTs available to purchase.”
    • Holly Lorentson, wondered who would perform lab audits in 2024: the existing vendor for WSLCB, RJ Lee, or DOE staff (audio - 1m).
      • According to Rue, the DOE would be “ramping up our program starting in July” but staff would be unlikely to “get out for an audit as early as August.” He understood WSLCB officials had “extended the contract with RJ Lee to continue audits through 2024.” He expected it would depend on the audit schedule for each lab.
    • Jay Burns, Treeline Analytics Laboratory Director, wanted to know where in rule WSLCB would have the authority to grant in-matrix PT waivers (audio - 7m).
      • “I don’t believe there is a WAC” on that topic, Rue answered, uncertain whether it would be required. Hoffmann spoke up to say it would be added in rule by DOE. Rue acknowledged it was in their proposed draft language as WAC 173-55-120, but the decision for the waiver would be up to representatives of WSLCB, adding, “we're assuming that…they would want to grant it.”
    • Burns proposed the final question, wanting an estimate “of when the manual for accreditation will be available” (audio - 11m).
      • Rue responded that the proposed WAC 173-55-120 also addressed the manual, which would be written by “the new team that will be hired after July 1st.” He anticipated it would be “closely modeled after the Environmental Lab Procedural Manual, but obviously it'll be customized for, for cannabis testing laboratories.” Rue said it was a “high priority” for future staff, but expected “it'll probably take at least a few months to get that written and published.” Until then, questions from labs should go to “to the accreditation team, the chemist, or full-time chemist that we dedicated to cannabis laboratories, as well as…the part-time microbiologist.”
  • The meeting concluded with a reminder that there was still time to offer input at another DOE accreditation workshop along with other avenues to enter formal comment before rulemaking language was proposed then finalized.

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