DOE - Cannabis Science Task Force Steering Committee
(September 27, 2019) - Summary

[ Event Details ]

CSTF leadership reviewed initial progress reports from its work groups on cannabis laboratory quality standards and proficiency testing.

Here are some observations from the Friday September 27th Department of Ecology (DOE) Cannabis Science Task Force Steering Committee public meeting.

My top 3 takeaways:

  • The Cannabis Science Task Force Steering Committee convened its second meeting (audio - 9m).
    • The DOE Cannabis Science Task Force (CSTF) first met on August 21st. The CSTF Steering Committee agreed to meet monthly while the work groups on Analytical Laboratory Quality Standards (Analytical) and Proficiency Testing (PT) planned to meet every two weeks. The task force documented its activity on a DOE website and notifications sent through an email list.
    • Annette Hoffmann, the CSTF Chair, called the meeting to order and led introductions of committee members, staff, and observers in attendance:
    • Hoffmann noted there had been “a legislative inquiry as to whether [the CSTF] can shorten our timeline” for transitioning laboratory accreditation from WSLCB to DOE. Hoffmann promised to return to the subject at the end of the meeting.
  • The Committee reviewed the proposed CSTF charter then heard progress reports from the Analytical and Proficiency Testing work groups.
    • Archer introduced the CSTF draft charter (audio - 38m).
      • She noted the first section outlining the group’s purpose and charge was largely taken from the enacting legislation, HB 2052. Archer then reminded the committee of the July 1, 2020 and December 1, 2021 deadlines to submit reports to the legislature on laboratory quality standards for pesticides in plants and additional lab quality standards, respectively. She noted the second lab quality standards report “will cover heavy metals and potency.” Archer believed it was important to remember “as part of these reports we’re also tasked with including the regulatory update needed, related to those lab quality standards.” She indicated DOE was looking to fill an administrative position for the task force and while Sekerak had been head of the Proficiency Testing work group, the department intended to hire a new chemist for the role. Otherwise, Archer confirmed that DOE had filled the required positions in the charter with staff from their department or the other agencies involved.
      • Doughty asked who was responsible for reaching out to other jurisdictions as detailed in Section 1.1.4 of the charter (“To the fullest extent possible, the task force must consult with other jurisdictions that established, or are establishing marijuana testing programs.”) Archer answered that outreach was “happening through the work groups” and said Sekerak had reached out to officials “in Colorado and New York and other folks.”
      • Doughty wanted to know if DOE considered “performance-based” testing methods an example of an “Appropriate approved testing method” in section 2.2.1.1. Archer responded that “figuring out what the legislative language allows [the CSTF] to do” was part of the process but that their role was to make recommendations to lawmakers for appropriate testing methods rather than design their implementation. Staff encouraged Doughty to raise that distinction within the Analytical work group.
      • Archer then reviewed the “Roles and Responsibilities” of task force members. DOE aimed to keep Steering Committee membership “static” but work groups would “be able to tap into other expertise” with revolving participation as issues arose. The Steering Committee could vote to add new permanent members to either work group if they believed it was warranted. Archer pointed out that some Steering Committee members wouldn’t be able to vote, citing Sekerak as someone on both work groups and the Steering Committee, but having no vote in the latter group.
      • The membership of the Steering Committee and both work groups was listed in the charter draft:
        • Steering Committee Members
          • Annette Hoffmann, DOE, Chair
          • Kendra Hodgson, WSLCB Appointee
          • Shelly Rowden, DOH Appointee
          • Brad White, WSDA Appointee
          • Jessica Archer, DOE
          • Amber Wise, Medicine Creek Analytics
          • Jeff Doughty, Capitol Analysis
          • Nick Mosely, Confidence Analytics
          • Nicholas Poolman, WSLCB (Non-Voting)
          • Sara Sekerak, DOE, Lead Chemist for the Task Force (Non-Voting)
          • Mike Firman, WSDA, Analytical Work Group Lead (Non-Voting)
          • TBD PT Work Group Lead (Non-Voting)
        • Analytical Work Group
          • Mike Firman, WSDA, Lead of the Analytical Work Group
          • Sara Sekerak, DOE
          • Steve Officer/Caroline West, DOH
          • John Weakland, DOE
          • Nicholas Poolman, WSLCB
          • Tania Sasaki, Confidence Analytics
          • Matt Hall, Praxis Laboratories
          • Ben Hart, Testing Technologies
          • Julie Kowalski, Trace Analytics
          • Kyle Shelton, Medicine Creek Analytics
        • Proficiency Testing Work Group
          • Sara Sekerak, DOE, Lead of the PT Work Group
          • Chemist 4, DOE
          • Steve LaCroix, DOH
          • Laboratory Accreditation Unit, DOE
          • Nicolas Poolman, WSLCB
          • Taber Salewsky, Praxis Laboratories
          • Jay Burns, Treeline Analytics
          • Stephen Loague, Integrity Labs
      • Looking at the responsibilities of CSTF members in section 3.1.2, Archer stressed the importance of engagement at all meetings by Steering Committee members. She argued that rotating members sapped meeting efficiency by requiring updates on the CSTF’s earlier activities. Mosely asked to clarify the ability to send proxies to meetings as several lab members were “businessmen, too.” Archer replied that they were looking for a “balance” of dedication and experience from participants. Hodgson noted that individuals from labs had been appointed to the CSTF directly, not their organizations, and appointed based on their expertise and skill sets. Following some deliberation among committee members an agreement emerged to allow proxy members but not let them exercise voting rights. Archer confirmed any member who routinely missing meetings risked losing their appointment.
      • Archer explained that beyond serving as Steering Committee chair, Hoffmann would also be the CSTF’s lead spokesperson and facilitator for dialogue between the CSTF and other agencies while stressing that members were free to communicate among each other. The draft charter allowed for members to discuss “key messages” of the CSTF but beyond that the members “must be explicit that they speak for themselves or for the constituency they represent.” Hoffmann instructed the Steering Committee that if they “have an opportunity to help [the CSTF] message get out, take it.”
      • Archer outlined the Steering Committee’s role in voting on work group recommendations and voiced optimism that most Steering Committee decisions would achieve “consensus.” She noted section 4.3: “If consensus cannot be reached after substantive discussion, the Chair may ask for a vote using a modified version of Robert’s Rules of Order (Appendix B). The vote will carry if two-thirds (66%, rounded down of the members present vote in favor.” And section 4.4: “Minority reports will be allowed for all decisions and use in Task Force reports and meeting summaries that will highlight the pros and cons of the actions discussed.”
      • Archer pointed out that the Steering Committee’s responsibilities included section 3.3.2.7: “In view of a need for timely results and in recognition that the Task Force is breaking new ground, the steering committee will review the timeline periodically, look for efficiencies, develop interim recommendations as appropriate to implement these efficiencies, as well as identify unanticipated challenges with solutions.” Hoffmann said her intention was that there be “no surprises” when it came to Steering Committee actions due to a deliberative and collaborative process. The charter also confirmed that Steering Committee meetings would remain open to the public and include a designated public comment period.
      • Following a review of feedback, Hoffmann said DOE would redraft the charter and send it out for an electronic vote "within a week" (audio - 10m).
    • Firman presented the first report from the Analytical work group which had already met three times in its first month for approximately 15 hours.
      • He emphasized the group had more work ahead but had already identified two major recommendations, numerous minor recommendations, and “side issues.” Firman added that the work group was in the process of reviewing model documents from other government bodies like the U.S. Department of Agriculture’s (USDA) Pesticide Data Program (audio - 3m).
      • The first major recommendation the work group offered was to adopt performance-based methods: “a specific method, instrument, or detection method is not required instead a set of performance standards that any method, instrument, or detection method [must] meet should be set.” Firman indicated DOE would “set forth what criteria we expect the lab to do, its validation criteria and its [quality control] QC criteria.” Performance-based methods would accommodate the addition of new compounds, changed detection levels, or new instrumentation. He called it a “good approach for the long term” similar to the methods used by the USDA and the European Union (EU)’s SANTE guidelines. Firman acknowledged that the process left more work for labs to demonstrate the validation of their methods, but allowed the CSTF to meet its required timeline. Mosely was supportive as it “allowed the labs to perform well.” Wise asked who defined the performance-based methods and Archer indicated it was one of the responsibilities of the task force (audio - 15m).
      • The second major recommendation the work group provided centered on determining who the labs considered their “client” for the purpose of validating lab methods and data usage. He suggested that testing could be undertaken for enforcement, risk assessment, or ascertaining “dosing levels” and that the requirements of the particular client determined the appropriateness of the methods utilized and data generated. Archer said that DOE had overseen other testing methods as the client and the distinction was crucial to determining which regulators had what authority over cannabis testing. Firman said the “overall theory” of determining the client was about the “fit to purpose” of validation methods which the client could choose and then communicate to the lab. He explained that one gap his work group had identified related to what data a lab would need to collect based on as yet undetermined client needs. An understanding developed that for the purpose of testing cannabis plants, Washington State regulatory agencies would be the client. Should a lab choose to test samples for another purpose, the business or individual hiring the lab was responsible for communicating their desired testing and validation methods. Mosely asked if the client was responsible for determining if a sample result was pass or fail or whether that was a function of lab personnel. Firman said he’d seen “both those things in the past” but in this case the client would instruct the lab how they wanted results reported. Hoffmann wrapped up the discussion saying the Steering Committee would return to the issue of defining clients at future meetings after doing more “interim work” (audio - 23m).
      • Firman swiftly listed the Analytical work group’s minor recommendations (audio - 11m):
        • “Sampling must be sufficient for testing. The lab shall reject samples that are too small. The lab shall set a minimum size for the method.”
        • “The sample must meet the [WS]LCB requirements: four grams, four portions. The lab will reject samples that do not meet the requirements in terms of size and portions and a sample must be delivered in the proper way.” A lab could reject samples for reasons like contamination.
        • “Testing is ‘as-is.’ Sample results are on a received basis. We’re not doing any moisture corrections or any other corrections.” A lab must indicate the reason for rejecting any samples they’ve received.
        • “Traceability: We want to control traceability for all the [testing] methods and all supplies and crew must be identified and able to trace back to the source.”
        • Firman said DOE wanted rules in place regarding “cutting off stems of flowers.”
        • The work group recommended setting “limits of quantitation” “at or below” action levels in rule rather than specifying a mutable value.
        • Regarding “sample storage” Firman said that discussions within the work group continued but the general consensus was that samples needed to be refrigerated for “up to 72 hours prior to testing, but after that they need to be frozen, 30 [degrees] below or lower.”
      • The Analytical work group identified a model document from the USDA Agricultural Marketing Service Pesticide Data Program which could be adapted to the CSTF’s purposes. The model document grouped substances to test into “commodity groups and commodities” which prompted the work group to recommend cannabis be designated its own commodity with three commodity sub-groups: high tetrahydrocannabinol (THC) cannabis, high cannabidiol (CBD) cannabis, and cannabis high in both THC and CBD. This drew pushback from Mosely who asserted the sub-groups were “arbitrary.” Firman noted that testing matrices would differ based on the type of plant but Mosely argued this could be addressed by establishing a better testing method. The members agreed there was still time to change if and how the CSTF would recommend a commodity designation for cannabis (audio - 13m).
      • Firman reported that WSLCB’s traceability system, MJ Freeway’s Leaf Data Systems, had some “incompatibilities with traditional analytical reporting” such as requiring a “zero” in fields where such a value was not possible and not “recording codes or comments.”
    • Next, Sekerak provided a progress report on behalf of the Proficiency Testing work group, indicating the group had hosted two meetings over roughly seven hours and was “looking at the big picture” (audio - 18m).
      • Information on the WSLCB’s cannabis laboratory PT program:
      • Sekerak said the PT work group had identified potential problems with WSLCB’s existing PT program such as:
        • “Lack of clarity in the rules and regulations.”
        • A lack of PTs “that matches the list available in Washington.”
        • “PTs are needed in matrix.”
        • “...not great communication with providers.”
        • “The frequency and expense of required PT.”
      • Hodgson asked for historical background on the creation of WSLCB’s PT program as “this predates some of us with [WS]LCB.” She asked whether “in the conversations and what was ultimately implemented are there gaps? Or [is] what was implemented what was discussed?” Mosely replied the quality assurance (QA) work group in 2016 “only briefly” talked about PT. Though aware it had been added, Mosely didn’t “remember a lot of industry feedback on that.” He also asserted that “a lot of the deficiencies are outside of [WS]LCB’s control.”
      • Doughty suggested an addition to Sekerak’s list: “We’ve actually noticed variation between different PTs, different standards [between providers] that’s pretty concerning.” Archer agreed it had been a prior concern.
      • Sekerak reported that the work group was reviewing WAC 314-55-1025 to determine its “capacity to achieve” AOAC International's objectives for PT standards. She said the group also endeavored to “identify problems in labs and initiate corrective actions which may involve staff performance or instrument calibration.” The work group hoped to “provide additional confidence to the client and to the public” and “identify individual lab differences and determine performance characteristics of the methods” in addition to “ongoing assessment and validation of approved methods.” The work group found the current rule was “overall not supportive of an effective PT” as it failed to meet AOAC’s criteria.
      • Furthermore, Sekerak anticipated “there’s real potential issues for authority, local authority, and conflicting authorities with what’s laid out” in the current WAC. One change would be “terminology edits” and “items needing removal for accreditation shift [from WSLCB] to Ecology” to avoid redundant language. She noted the relevant sections of the WAC were “currently open” as part of WSLCB’s Quality Assurance Testing and Product Requirements rulemaking and added that the “public comment period” was still open. Sekerak said the PT work group wasn’t comfortable suggesting edits to the WAC “right now, but our work has just begun.”
      • Sekerak stated that the major findings of the work group thus far:
        • PT needed to be the responsibility of a “science-based” state organization - an agency or division or “individuals from multiple agencies serving as a standing committee, technical body, or advisory panel.” Sekerak speculated this could be a new division of a state agency like WSLCB, a partnership between two agencies, or an altogether new state agency.
        • PT programs could be state-administered, state-managed third party providers, or have the state “provide technical oversight for out-of-state PT providers.” Hodgson observed that the legal cannabis states she’d spoken to had not opted for a state-administered program. Sekerak and Mosely acknowledged that but noted that getting an in-state PT vendor for roughly a dozen cannabis labs might not be feasible as most PT providers focused on meeting federal or international standards rather than state-level. The best way to ensure PT was “in-matrix” might be for Washington to administer PT itself.
      • The PT work group’s next steps included reviewing all PT provider options and inviting providers to present to the work group at future meetings. Sekerak specifically mentioned Phenova's cannabis and hemp PT as a possible system the group wanted to know more about. The work group would also continue reviewing other states’ programs.
      • Doughty raised the issue of costs for the changes under consideration. Mosely followed up to ask if the CSTF would make budget requests of the legislature to fund their recommendations. Archer was non-committal, saying the CSTF would present their reports to the legislature and that it was possible DOE would put forward agency request legislation on the CSTF’s recommendations. Carlson noted past DOE reports featured cost estimates. Hoffmann cautioned members that while cost was “good to have in mind,” it was still “down the road.” She urged the group to focus on fulfilling the “intent of the bill.”
  • The Steering Committee hosted its first public feedback session and discussed next steps.
    • Hirt inquired about pre-laboratory cannabis sampling, saying that he’d “been involved with one of the major accreditation bodies...in the ISO/ILAC world.” He noted that the work of accredited labs was often “not valuable because of the sampling” and wanted to know if the CSTF would create a “checklist” for proper sampling so that people “could have confidence in the results.” Sekerak noted that while individual labs could set up their own sampling guidelines, DOE wasn’t prepared to set a statewide standard as it was “outside what we’re looking at.” Nonetheless, she said staff would point out potential sampling problems whenever they saw them. Wise suggested pre-laboratory sampling guidelines merited a mention in the CSTF’s final legislative report. Hirt said that his company had been involved in developing lab standards in other states and was prepared to share his expertise with Washington’s industry (audio - 6m).
    • A comment submitted via chat from “John” asked about WSDA’s sampling policy on “testing pesticides in wheat” in accordance with USDA standards. Hirt added that USDA ensured samples were “representative of the agricultural products they’re testing.” Firman confirmed that wheat sampling was collected as part of USDA’s Grain Inspection Program which had “comprehensive” guidelines on sampling which were currently used by agriculture inspectors in Washington state (audio - 4m).
    • Mike Rochlin, participating remotely, commented that he used to work for the Washington State Department of Labor and Industries Division of Occupational Safety and Health and that the federal Occupational Safety and Health Administration (OSHA) sampling standards “are predicated on analytical methods as a group.” Rochlin’s point was that sampling needed to be part of the overall testing criteria “even though you may have [a] scope that’s narrow please make sure you put that as a pertinent recommendation to look at sampling in conjunction with analysis” (audio - 4m).
    • Hoffmann looked ahead to next steps for the Steering Committee (audio - 36m).
      • The Steering Committee planned subsequent meetings which were expected to run longer:
        • October 18th
        • November 15th
        • December 16th
      • Hoffmann helped the group define “key messages” emerging from the Steering Committee meeting.
        • Hoffmann offered a first message: “the Analytical work group is a work in progress” but overall the CSTF was taking “big steps.”
        • Archer suggested an acknowledgment that cannabis was a “growing and changing industry” and that the Steering Committee intended to “allow flexibility into the future.”
        • Doughty said that “rigor” should be the Steering Committee’s top priority, followed closely by “timeliness.” Doughty and Mosely added that “cost effective” recommendations were also key. 
        • Hoffmann mentioned the CSTF’s timeline for their first year and promised to collaborate with the state agencies involved to create a “more detailed timeline” to refine as the Steering Committee met to identify “areas to shorten.” Hoffmann said the Steering Committee could accelerate the “rulemaking or the regulatory cycle” and developments from the work groups’ initial meetings or research that could be applied to the second report’s recommendations around pesticide and heavy metals testing.
        • Returning to sampling, there was agreement that it wasn’t a key message, but the Steering Committee could note it was “tracking side issues” including sampling.
      • Considering “interim recommendations,” Hoffmann noted the CSTF’s first report in July of 2020 would focus on addressing questions raised by the legislature. However, any problem that could be “unblocked” through interim recommendations to state agencies would be pursued by Hoffmann in her capacity as Chair assuming the suggestions were “in scope.”
        • Hodgson asked if there was consensus for the work groups to continue pursuit of “performance-based measures” which renewed discussion about the definition of “client.” Hoffmann advised development of an interim recommendation whereby agencies involved in cannabis testing regulation “work out” their own definition of “client” for the CSTF to consider as they formed final recommendations.
      • For communication, Hoffmann saw a need for “interaction” with the work group members as opposed to “reporting and listening.” She encouraged members to prioritize the comments or concerns of their constituencies to avoid getting “into the weeds” of questions which could be interesting but less crucial for the Steering Committee’s work. Archer explained that she was setting up a box.com site for Steering Committee members to access common documents and share information. She said DOE would set up a separate “easy view” site for documents available to the public in addition to DOE’s CSTF webpage.
      • Hoffmann said the charter would be refined based on member suggestions and she hoped to achieve “100% consensus” on approval of the new version.