DOE - Cannabis Science Task Force Steering Committee
(August 21, 2019)

Wednesday August 21, 2019 10:15 AM - 12:45 PM Observed
Washington State Department of Ecology (DOE) Logo

The Washington State Department of Ecology (DOE) Cannabis Science Task Force (CSTF) Steering Committee is the leadership committee affecting the transition of responsibility for cannabis testing lab accreditation from the Washington State Liquor and Cannabis Board (WSLCB) to the DOE. In the absence of federal guidance, the Committee is also helping bolster cannabis testing lab standards.

https://www.ezview.wa.gov/.../alias__1962/37551/cannabis_science_task_force.aspx

Observations

The Washington State Department of Ecology launched the Cannabis Science Task Force to assist in the methodical migration of authority for testing lab accreditation from the WSLCB.

Here are some observations from the Wednesday August 21st Washington State Department of Ecology (DOE) Cannabis Science Task Force (CSTF) Steering Committee meeting.

My top 3 takeaways:

  • CSTF Chair Annette Hoffmann welcomed the task force members who introduced themselves in turn.
    • Hoffmann introduced herself as the newly hired Program Manager of the Department of Ecology’s Environmental Assessment Program, having formerly worked at the Washington Department of Fish and Wildlife (WDFW). Admitting she was “new to Ecology, and I’m very new to this issue,” Hoffmann emphasized that she brought a “fresh set of eyes” to the topic of cannabis laboratory oversight and would be “relying on the expertise that’s on the task force” (audio – 5m).
    • Leading introductions, Hoffmann encouraged task force members to provide their name, affiliated organization, and “their role on the task force” (audio – 4m).
    • Hoffmann noted that Steering Committee meetings would be open to the public and run “in a very transparent, open way.” She promised to make information available through DOE’s task force webpage and email list. Hoffmann asked that members with concerns outside the “fairly narrow scope of work” for the group add them to a “parking list” of “outside” issues to address through other channels.
  • Following introductory presentations from DOE staff, cannabis testing laboratory members had questions for regulators.
    • Sekerak shared a presentation on DOE’s 2018 interim study which established a basis for the transfer of lab accreditation to Ecology and the formation of the CSTF (audio – 21m).
      • In 2018, SB 6032 appropriated $98,000 to the DOE “to begin conducting research into appropriate protocols and accreditation standards for marijuana testing laboratories.” The agency’s recommendations were published in November of 2018. Sekerak confirmed that the recommendations were a contributing factor to the successful passage of HB 2052 into law earlier this year which established the CSTF.
      • Sekerak briefed the CSTF on the definition of “accreditation” used by DOE. She said accreditation was “a formal recognition that a laboratory has a technical competence in the systems in place to produce accurate and defensible data.” To do this “requires an evaluation of the lab’s quality system, staff, facilities, test methods, records, reports” which would be performed by “separate entities” who objectively evaluate labs using rules set by DOE. The ultimate goal was ensuring required methods and standards “are practiced and applied appropriately” even though accreditation couldn’t prevent “intentional fraud, inadvertent error, or just incompetence.” Sekerak said DOE currently accredited 460 labs through the department’s “initial and continuing” accreditation process.
      • Sekerak emphasized several definitions in the 2018 report:
        • Product Standards. “The regulatory requirements that [labs] find the acceptable content of consumer product” in terms of composition and absence of contaminants. For cannabis, Sekerak said this included “potency levels, pesticide limits, [and] mycotoxins limits.”
        • Laboratory Quality Standards. “Methods, method validation protocol, and performance criteria” that “provide laboratories with widely accepted standardized procedures” in addition to the “critical elements for accreditation to accredit to.”
        • Accreditation Standards. “What are used to evaluate the lab’s ability to produce accurate and defensible data” as well as “the structure, the fee structure, how many times [accreditors] go in, what sort of documents they review, what they look at overall.” Sekerak emphasized accreditation standards were not “the specific methods that the laboratory uses.”
        • Proficiency Testing (PT). Sekerak conceded “appropriate PT samples are not currently available” even though it is “an integral part of accreditation.” Sekerak added that DOE was interested in “matrix-based PTs as well as standards.”
        • Accreditation to the good laboratory practice checklist. While “based off the ISO[/IEC] 17025” standard, it lacked the “requirements to implement specific [quality assurance/quality control]” which created a lack of specificity in laboratory quality standards and was “not an effective accreditation mechanism.”
      • To create the report, DOE researched and reviewed data from labs in Washington and other states. Looking at “critical gaps and challenges,” Sekerak said the department found a “lack of widely accepted standard methods” – a key reason they weren’t able to “support a robust science-based cannabis laboratory accreditation program.” The lack of any federal frameworks around cannabis was another challenge and the “current method that’s cited in [WAC 314-55-0995(3)(b)]” was “insufficient” as it was neither peer-reviewed, nor “a compendium of methods.”
      • Later, Sekerak called out “sampling procedures and sample homogenization” and “sampling from the source sample” as challenges due to the fact that growers currently collect their own samples and “untrained samplers may lack the technical competence” to ensure homogenization. She added, “bias introduced in this stage initially will persist through the entire system.”
      • These challenges changed the scope of DOE’s recommendations to lawmakers, with the department suggesting multiple “models for moving into the future for lab accreditation.” Model 1 was implemented as HB 2052 and adopted by the legislature to transition accreditation to Ecology, form the CSTF, and establish a timeline for rule updates.
      • HB 2052 mandated the state “maintain the current provider” of lab accreditation until transfer of authority to the DOE was completed in 2024, by which time “better standards would be in place.” Sekerak believed the lengthy transition was necessary because “science takes a lot of time.”
    • Carlson, DOE’s policy coordinator for the CSTF, walked members through a presentation on HB 2052 (audio – 14m).
      • The timeline established in HB 2052 required the CSTF to compose two reports to the legislature. The first, on “lab quality standards for pesticides in plants”—terminology which Carlson stressed was “in session law”—was due July 1st, 2020. The second, on “additional laboratory quality standards, including, but not limited to, heavy metals in and potency of marijuana products” was required by December 1st, 2021. From there, DOE was granted two years for necessary rule and policy changes before gaining full authority over cannabis lab accreditation by July 1st, 2024.
      • Both reports “must include recommendations relating to:
        • Appropriate approved testing methods
        • Method validation protocols
        • Method performance criteria
        • Sampling and homogenization protocols
        • Proficiency testing
        • Regulatory updates related to these items”
      • Carlson said HB 2052 granted DOE rulemaking authority “to establish an accreditation program for the cannabis labs” and allowed the agency “to establish fees to cover the cost of running the accreditation program.” The CSTF was the “biggest piece” of the “groundwork” for that transfer of responsibility.
    • Archer followed up to describe the implementation of the CSTF’s roadmap.
      • She began by describing steps already taken. State agency representatives had been appointed by each agency’s director or their designee. Cannabis labs and industry groups were surveyed by DOE staff to find potential members for the Steering Committee and work groups. State agency appointees then selected particular industry representatives for membership on the CSTF. Archer pointed out DOE had achieved the first requirement of the new law by selecting task force members and meeting before September 1st.
      • Archer created the CSTF’s timeline for the first year by reverse engineering actions needed before submitting the first report to the legislature. She noted “there are a lot of internal review steps that have to happen” including Steering Committee review of work group findings, review of CSTF publications by DOE staff, and then review by the Governor’s office. From there tribal nations would be consulted. Accounting for this, Archer concluded “we need to start writing the [first] report December 1st [2019].” She asked for participants to be “present, focused, [and] committed” to the project.
      • HB 2052 defined the CSTF’s initial structure to include an overarching Steering Committee supported by two work groups. WSDA was assigned responsibility to lead a Lab Quality Standards Work Group while DOE managed a Proficiency Testing Work Group. Firman and Sekerak would lead their respective work groups, with Sekerak mentioning DOE intended to hire another chemist who would step into her role on the PT Work Group. The composition and responsibilities of each body included:
      • “Steering Committee –
        • Diverse membership (state agency, commercial laboratory, tribal interests)
        • Vote on items brought forward by the work groups, cannot be work group members.
        • Active in cannabis community
        • Pesticide knowledge and experience (especially AOAC, USDA, FDA methods)
        • Balance between policy and technical expertise
        • Serve for the full term of the Task Force
        • Vote in new work group members after initial appointments
      • Analytical Workgroup [or, Lab Quality Standards Work Group] –
        • Lead by Department of Agriculture (lead presents to steering committee)
        • Technical workgroup composed primarily of chemists with pesticide expertise (especially AOAC, USDA, FDA methods)
        • Membership could change as technical needs change
        • Present items to steering committee
        • Members cannot be voting members on the steering committee
      • Proficiency Testing Workgroup –
        • Lead by Department of Ecology (lead presents to steering committee)
        • Technical workgroup with a variety of laboratory expertise
        • Membership could change as technical needs change
        • Presents items to steering committee
        • Members cannot be voting members on the steering committee”
      • Archer reported the Steering Committee would initially focus on creating a charter for the CSTF. Work group leads would bring proposals to the Steering Committee, who would vote on them. The Steering Committee meetings would be open to the public, while the work groups would remain closed.
    • Wise, from Medicine Creek Analytics, asked about the types of labs DOE already accredited. Wood, Supervisor of DOE’s Environmental Laboratory Accreditation Program, answered that the agency accredited commercial, industrial, academic, municipal, and government labs in addition to labs for wastewater treatment facilities. Wood agreed DOE’s currently accredited labs were “all environmental focused” (audio – 2m).
    • Newman, the Laboratory Director at Praxis Laboratory, asked about ‘Model 2’ in DOE’s 2018 recommendations and its relation to ISO accreditation. Admitting those standards were considered “more general, broad, and may not specifically address cannabis,” he pointed out the American Association for Lab Accreditation’s (A2LA) Cannabis Testing Laboratory Accreditation Program incorporated ISO-17025, did “refer directly to cannabis and is also used for their pharmaceutical labs as well as environmental labs.” Newman challenged the DOE to explain how it was “better suited to look at cannabis testing” (audio – 12m).
      • Sekerak replied that DOE was assigned the task because the department was “the only agency that performed accreditation.” She agreed that the ISO standard had value and “A2LA does provide a cannabis scope” but remained a private organization which would require vetting and a contract with state regulators.
      • Archer said ISO-17025 was “broadscope accreditation” and done very differently than the “parameter specific” accreditation DOE performed. As well, cannabis testing still didn’t have “defined methods” common in other industries.
      • Wood elaborated that A2LA accredited many standards and that ISO-17025 was about quality assurance (QA) systems. Newman pushed back, saying “it does require a specific validation procedure that’s also used, for instance, in AOAC. It’s also matrix-specific and analyte specific.” Wood agreed ISO-17025 had “quality assurance portions” but that it didn’t “look at the level that [DOE looks] at” for accreditation. “In no circumstances [does DOE] accept the ISO standard alone,” she concluded.
      • Firman asserted A2LA paired a general ISO standard with AOAC, but let a contracted client decline to be accredited for AOAC or other specific standards. Sekerak indicated this was part of the difference in contracting with a private business versus a state entity. 
      • Hodgson stated that some labs have voluntarily taken on accreditation to the ISO-17025 standard, but pointed out earlier efforts to legislate this requirement hadn’t advanced.
      • Hart, Senior Scientist at Testing Technologies, said private accreditation to ISO standards reminded him of the situation with WSLCB’s current vendor for lab accreditation, RJ Lee, in that “there wasn’t enough control” to ensure the accreditor was holding cannabis labs accountable. The desire to retain labs as customers created numerous conflicts of interest for private entities accrediting labs, according to Hart.
        • Find out more about RJ Lee from discussions during WSLCB public meetings on November 14th and June 3rd.
    • Mosely, CEO at Confidence Analytics, asked if WSDA’s Chemical and Hop Laboratory had pesticide expertise. Wood said they mostly dealt with Environmental Protection Agency (EPA) standards. Archer indicated that experience was why WSDA’s Firman would lead the Lab Quality Standards Work Group’s review of analytical methods (audio – 2m).
    • Mosely was also curious how the state-appointed task force members selected industry representatives for participation. Archer replied that their survey had received between 30 and 40 responses and from there staff created a matrix to prioritize labs with current pesticide testing experience. Sekerak said DOE had reached out to all cannabis labs individually, but not all responded. Officials also looked for a diverse task force composition with “policy [and] technical” knowledge while maintaining a “manageable size” (audio – 3m).
  • An open listening session garnered more questions and significant engagement before Chair Hoffmann closed the two hour meeting with an outline of the CSTF’s next steps.
    • Hodgson offered background on the QA Testing and Product Requirements rulemaking process. The central question asked was whether there should be testing of “pesticides and heavy metal for all products.” This impacted not only how labs would be accredited, but also what specific tests might be required by the state. Hodgson said they had work to do on “what is the list” of pesticides to be tested for and hoped WSLCB could “get at that question” while contributing to the CSTF alongside other agencies. Mosely asked if this meant the agency would be “opening up the list” of approved pesticides and action levels in WAC 314-55-108, a step he thought should happen before a revamped accreditation process. Archer indicated DOE staff had talked over that shared concern and were reviewing both WSLCB’s action levels and DOH’s levels for medically compliant products in WAC 246-70-050 (audio – 6m). 
    • Wise raised an emerging issue around the term “potency” saying “we should get away from incorrect usage of [potency] and use ‘cannabinoid profile’ or ‘cannabinoid percentage’” when discussing tests. Hodgson was interested in a “more accurate description” for state rules causing Mosely to suggest ‘THC percentage’. “Potency implies a subjective judgement about how much of an effect this is going to give me,” he continued, “and the labs don’t actually have a way of measuring that.” This was complicated according to Mosely because cannabis “does not have a very straightforward dose/response relationship.” Sekerak felt the distinction belonged on the “parking lot” list as it wouldn’t be addressed at that point. Hodgson encouraged the task force to see that a “commentary” on the wording issue was added to one of the reports “to help educate” lawmakers and the public (audio – 5m).
    • Burns, Laboratory Director at Treeline Analytics, asked about QA sampling performed by producers and processors and whether it would be addressed in the CSTF’s timeline. “If you don’t have a good sample, you don’t have any good data,” he said. Sekerak responded that the task force was mandated to focus on the behaviors of labs and that sampling practices outside of the laboratory context was beyond the scope of the CSTF’s charge. Regardless, she acknowledged “challenges” for any accreditation system relying on producers to submit their own test samples. Newman claimed a “thorough procedure on sampling” existed in WAC 314-55-101 but wasn’t consistently enforced. “We can have third parties, we can have the lab do the sampling, but if nobody’s enforcing it, it doesn’t matter what you have in the bill.” Hodgson said WSLCB had discussed adding a review of sampling protocols to Enforcement visits to validate licensee procedures. DOE staff were open to mentioning the issue in the second CSTF report, but believed it related more closely to investigations of licensees than oversight of labs (audio – 6m).
    • Doughty, Capitol Analysis CEO and Laboratory Manager, pursued the topic of investigations to understand what role DOE would play in enforcement (audio – 14m).
      • Archer said the department didn’t currently have “an investigative unit that looks at fraud” and wouldn’t lead those investigations. She did allow that DOE occasionally exposed fraud through lab audits “but it’s a whole different realm” from a proactive investigatory body at the department.
      • Hart asked if the legislature would need to give DOE more regulatory authority for the department to do that, which Hodgson confirmed. Wood explained that DOE, in particular the laboratory accreditation unit, “begins their investigation when that sample arrives.” Sekerak added that for environmental samples collected by DOE, a project sampling plan is required.
      • Archer said the relationship between DOH and DOE for water quality sampling is an “appropriate analogy” for how agencies could work together. Others noted that it would be difficult to get consistent behavior if sample gathering was under WSLCB authority but sample testing was the purview of DOE. Firman mentioned federal agencies had complex, intertwining authorities over sampling protocols.
      • Doughty lamented that “this is currently being used to falsify data. And this is one of the major problems that we’re facing.” Sekerak was sympathetic but recognized a path to resolution was “already separated by two different WACs.”
    • Newman returned to the state’s list of pesticides approved for use on cannabis, arguing that changes in the list had ramifications for labs. Hodgson said the WSLCB planned to provide a timeline to both growers and labs to “stagger in” changes. She said the heavy metals list was more straightforward and would likely be completed first. By contrast, pesticides were a larger list which necessitated opening WAC 314-55-108 for changes, and not everyone agreed what those changes should be. Complicating things were the multiple rule processes “already in flight” that could be impacted by changes to approved pesticides or their action levels. Doughty asked where the list fit into the overall timeline for the CSTF as different pesticides could require labs to invest in new equipment. Staff said they were endeavoring to be “flexible” on updating pesticides while prioritizing the scheduling required under HB 2052 (audio – 4m).
    • Zitzer, Trace Analytics COO, wanted to know if WSLCB set pesticide action levels or just identified what pesticides were permitted. Hodgson said WSLCB and DOH “own” those rules “as of right now, those action limits as they live now.” Zitzer pursued the line of questioning to ask what would happen if DOE encountered a lab with instrumentation or methods that were unable to detect contaminants at regulated action limits. Wood suggested that DOH required water testing labs to meet a state detection reporting limit (SDRL) to identify contaminants in water which DOE enforced through examination of lab instrumentation method detection limits (audio – 4m).
    • Wise brought up the impact of DOE’s audits, wanting to know if they carried immediate effects for labs. Wood explained that an audit’s “findings” could require “corrective action” or revoke their accreditation “for that specific parameter” until the lab corrected it (audio – 1m).
    • Doughty asked if DOE’s cannabis lab accreditation unit would be the current auditing group and the expected wait time for accreditation. Archer said DOE would hire additional auditors with some expertise around chemistry and/or toxicology. The agency typically requested documents 30 days ahead of site visits, which could take more than one day at the lab’s location. She cautioned, “our audit is much more rigorous than the current auditing system with RJ Lee” (audio – 3m).
    • Wrapping up the gathering, Hoffmann said the Steering Committee planned to meet once a month with the next meeting scheduled for September 27th. DOE would work to draft the CSTF’s charter during the interim for presentation and approval by the Steering Committee at the next meeting. Work group members agreed to meet later that day to develop “work plans” for drafting the CSTF’s first report on pesticides. “We’re trying to get it to somewhere solid landing by the end of December,” Hoffmann stated. She suggested work groups meet every two weeks while emphasizing schedules wouldn’t be managed by the Steering Committee. Hoffmann asked to see both groups’ draft work plans by the end of that day, adding that work group leaders would present initial findings at the September Steering Committee meeting (audio – 12m).

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