WA House COG - Committee Meeting
(November 18, 2021) - DOE CSTF Update

The chair of the cannabis science task force explained the work of the group, including its remaining report, and fielded a question about in-matrix proficiency tests.

Here are some observations from the Thursday November 18th Washington State House Commerce and Gaming Committee (WA House COG) Committee Meeting.

My top 3 takeaways:

• Annette Hoffmann, Department of Ecology (DOE) Environmental Assessment Program Manager and Cannabis Science Task Force (CSTF) Steering Committee Chair, went through recent activities of the group and their first report from June 2020.
  • Hoffmann reminded lawmakers of the 2019 legislation establishing the CSTF, which required movement of authority for cannabis testing laboratory accreditation to DOE from the Washington State Liquor and Cannabis Board (WSLCB) by July 2024. She testified that the “cannabis industry has evolved more rapidly than the science needed to support it" (audio - 8m, video, presentation). 
    • Hoffmann described accreditation as a “third-party process by which a laboratory is certified that it has the right resources needed to do a specific task” and “provide positive proof of that capability.” She compared it with someone getting their driver's license, as “there’s a written test to show that I understand the rules of the road,” as well as “a practical driving test that shows I can actually be competent on the road.” Given cannabis laboratories identify “their own testing methods, there have been reports of inconsistent testing results among laboratories which has reduced regulatory and consumer confidence,” Hoffmann stated.
    • As DOE staff “has extensive experience accrediting environmental and drinking water laboratories,” Hoffmann said legislators determined the department was “the appropriate body for cannabis. However, it also recognized that there were gaps in order to fill and implement...Ecology’s program.” She said this led to the mandated creation of the CSTF “to help fill those gaps.”
      • The task force first convened in August 2019. At publication time, the CSTF Steering Committee met most recently on October 25th and their next scheduled meeting was on Tuesday December 7th.
    • Hoffmann commented that “the first substantial gap identified was in scientifically-based and standardized lab quality standards and the second was to characterize successful proficiency testing.” She felt it was “worth pointing out that the terms ‘lab quality standards’ and ‘testing methods,’ as used here, really mean the same thing” and she’d use them interchangeably. The former was “written in statute,” but Hoffmann indicated the latter term was “really the practical application” of lab standards, and task force members found the phrase “lab quality standards” was regularly “confused with other kinds of standards like product standards, or lab accreditation standards.”
    • Under the existing accreditation system, Hoffmann said “a lab’s proficiency in one area certifies it for a broad scope, with Ecology’s model a lab must be certified...for and demonstrate proficiency in each specific combination of method, analyte, and matrix.”
      • Method “is the testing method or the lab quality standard.”
      • Analyte “is the substance that...you’re trying to find.”
      • Matrix “is the actual product being tested.”
    • Hoffmann observed that accreditation under DOE would involve several “pillars,” which she called a “substantial difference” from the existing system. She made clear that the pillars presented applied to the accreditation regime for each combination of method, analyte, and matrix:
      • “Personnel, Equipment and Supplies 
      • Sample and Data Management 
      • Methods and [Quality Assurance/Control] Protocols
      • Proficiency Testing”
      • The end purpose, Hoffman stated, was for the laboratory to show “positive proof that it can put all those things together in a way that provides accurate results in a blind study.”
    • The CSTF itself was a “cooperative effort with many bringing important experience, expertise, and authority...to the table.” There had been 42 participants throughout the group’s tenure, including staff from DOE, WSLCB, the Washington State Department of Health (DOH), and Washington State Department of Agriculture (WSDA), Hoffmann indicated, as well as representatives from nine accredited cannabis labs in the state. She added that the Steering Committee had representatives from all participating state agencies, in addition to staff from “Medicine Creek Analytics, Confidence Analytics, and Capitol Analysis Group.”
    • Efforts had been distributed among private work groups with focus areas “like pesticides, or heavy metals,” Hoffmann said, to do “the heavy lifting, comparing existing methods, having in-depth conversations about applicability, [and] developing proposed motions for recommendations or for testing methods.” These groups also allowed for cannabis laboratory members to “bring forward their own work on testing methods for consideration,” she noted, as well as evaluate testing processes and certifications in other legal cannabis jurisdictions.
    • Hoffmann described how motions were brought before the Steering Committee from the work groups, “along with the pros and the cons that [they’d] discussed.” Following questions, deliberations, and amendments to the motions, she explained that a vote was taken “and the motions either passed or failed,” and, occasionally, were “sent back to the work groups for revisions, or to deliberate other considerations.” Hoffmann remarked that under this system all the motions that came to a vote were passed, “and all but one passed unanimously.” “In the end, the task force recommendations on testing methods in the reports” started in the work groups, she concluded, and were vetted “through this decision making structure.”
  • Hoffmann referenced the first report released 17 months prior ("Cannabis Science Task Force Recommendations: Laboratory Quality Standards for Pesticides in Cannabis Plants and Products") which “addressed laboratory science to test for pesticides in plants and products” (audio - 2m, video). 
    • The task force had utilized “current procedures, and adapt[ed] them to cannabis,” Hoffmann commented, leaning “heavily on United State Department of Ag[rilculture] methods and procedures that were already in place and already had protections built into them.” A key theme task force members identified was “the need for some flexibility to enable the science to evolve with the industry,” so the report’s recommendations had “some flexibility built into it.” She cautioned that such flexibility “has a cost associated with it in the form of an ongoing regulatory oversight body,” suggesting that the justification for that body was “threaded throughout the work of the task force.”

• Hoffmann shed light on the second report from the CSTF due the following month, as well as the future of the task force before accreditation was transferred to DOE.
  • Hoffmann relayed that the second report from the task force “addresses other fields of testing, there’s potency, heavy metals, microbial elements, and residual solvents,” in addition to “proficiency testing that must be applied to all fields.” The group had “relied heavily on already approved agricultural and environmental testing industries and standards,” she said, leveraging “consumer protections that are already built into these methods” (audio - 4m, video).
    • The methods and programs “needed some adaptation to fit” with cannabis testing, stated Hoffmann. Flexibility remained important, she remarked, as “during the potency discussion...different opinions began to obstruct progress towards methods and recommendations.” Hoffmann told lawmakers that the Steering Committee “drafted guidance on flexibility for the work groups to follow.” This general guidance “largely favored prescriptive methods that were amenable to regular regulatory and accreditation needs” while still allowing for “creative work,” she said.
    • Another theme “on proficiency testing” came to light, Hoffmann indicated, “a study where an independent provider sends samples of product with known quantities of a chemical to laboratories.” She conveyed that a proficiency test (PT) used “all of the accreditation pillars and demonstrates that the lab” can provide “positive proof” that their staff “can follow the method correctly and produce accurate results.”
    • Hoffmann testified that an “essential element” of the report was that PTs “must be in cannabis when testing for pesticides, potency, or residual solvents,” and hemp samples were not an acceptable substitute. She emphasized that DOE officials concurred with this point. She claimed the task force had been “unable to identify a technical solution where hemp could be used as a surrogate for cannabis-based proficiency test,” but noted work group members went “looking for a solution” when articulating the “needs of a cannabis-based PT program.” The Proficiency Testing Work Group “designed a trial experiment to try to understand the logistic, and other barriers,” and found that “control mechanisms, for example licensing, or the traceability requirements” were policy obstacles the group could not solve.
    • According to Hoffmann, DOE officials “reached out, recently, to industry representatives and other agency staff, to brainstorm potential alternative technical solutions" that might “allow hemp matrix to be used as a surrogate.” Unfortunately, she noted, “based on those conversations we feel we’ve exhausted those possible technical solutions.” Hoffmann said agency representatives worried “whether or not the cannabis-based PTs will be available before we take on accreditation.”
      • DOE leadership crafted an agency request bill which would have eliminated the 2024 statutory deadline for the transfer of lab accreditation responsibility until three benchmarks were met: the formation of the ICT, lab standards in WSDA rule, and “availability of in-matrix cannabis proficiency tests for pesticides, potency, and residual solvents.” DOE staff claimed that only when these had been achieved would the department be able “to provide the accreditation program that was envisioned.” However, on October 1st, Hoffmann acknowledged that DOE leadership had decided not to pursue the request bill during the 2022 session after finding minimal support during “stakeholder outreach.”
  • Hoffmann described on-going work of the task force and request legislation to create an interagency coordination team (ICT) which had yet to be approved by Governor Inslee’s office for the 2022 legislative session (audio - 4m, video).
    • Going forward, Hoffmann said the CSTF would continue to evaluate “other fields of testing” around microbiology, mycotoxins, and water activity/moisture which weren’t finalized in time for the upcoming report. The additional topics would be included in memoranda sent to WSLCB “before the task force disbands.”
    • The potential joint request bill would “transfer authority for the testing methods” from WSLCB to WSDA, she commented, “and it would form that regulatory oversight body that you heard about.” Hoffman said the ICT would have representatives from the requesting agencies “as well as Department of Health,” and be tasked to:
      • “Provide guidance/validation needed to implement flexibility
      • Assist with coordination among agencies with different jurisdictions
      • Coordinate an in-state Cannabis-Matrix Proficiency Testing Program”
    • Considering the timeline for transfer of accreditation, Hoffmann noted the task force had met its initial benchmarks and “provided additional clarity on those details that were needed for implementation that were unforeseen in 2019.” She said this meant implementation would “not be as simple as might have been originally envisioned,” and would involve more than transferring authority and a new “fee schedule.” Hoffmann reinforced the need to create the ICT to handle “flexibility and the other list” of responsibilities such as the “cannabis-based proficiency testing studies in order to achieve the desired results of accuracy, consistency among labs, and the improved consumer protections that we’re looking for.” She affirmed that the 2024 transfer deadline “is dependent on those elements being in place.”
      • Hoffmann talked about “winding down” the CSTF with steering committee members on June 11th, and time was allocated to discuss “Sun Setting the Task Force” on Tuesday December 7th.

• Chair Shelley Kloba asked about in-matrix proficiency testing, believing it was preferable to set standards “according to cannabis.” She wondered if “there’s potentially a legislative fix that you see to the barriers” (audio - 4m, video). 
  • Hoffmann said the question indicated the “complexity” of the topic, noting CSTF members had focused on “the content and the science of the work, but there’s this companion component of implementation.” She noted that a “cannabis PT provider that does in-matrix, or in-cannabis based PTs for Colorado and for Oregon,” whose representative talked to the task force, was required to “sell their standards.” Such an arrangement was a “more complicated field of...what we can do with licenses,” Hoffmann conveyed, and the task force lacked “the ability to solve that.”
  • Kloba called attention to the precedent of “a research license,” of which state regulators had “only granted one” to date, and wondered aloud about other licenses “that we could create so that...the standards could be sold, for like, a very narrow purpose.” She added that her focus continued to be on how “the product needs to be safe, and consumers need to know exactly what they're buying.”

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