WSLCB - Listen and Learn Forum - Quality Control Testing and Product Requirements
(April 9, 2019) - Summary

[ Event Details ]

In a successful test of an innovative meeting format, the agency gathered feedback from the regulated community on cannabis sampling, cannabis testing, and lab proficiency testing.

Here are some observations from the April 9th WSLCB Listen and Learn Forum on the Quality Assurance Testing and Product Requirements rulemaking project. Today at 1:30pm, WSLCB will host a follow-up forum to gather additional feedback from the regulated community.

My top 3 takeaways:

  • WSLCB Policy and Rules Coordinator Kathy Hoffman and consultant Debbie Rough-Mack provided a thorough overview of the Quality Assurance Testing and Product Requirements rulemaking project (audio – 12m).
    • Check out Hoffman’s April 3rd update on the Quality Assurance (QA) Testing and Product Requirements rulemaking project, and subsequent May 29th and June 12th updates on project progress.
    • Hoffman began the session on April 9th by describing the rules process defined by the state’s Administrative Procedures Act. As the issue paper and CR-101 had been filed, the agency was in “rule development” and engaging stakeholders. Hoffman emphasized her belief that creation of “workable, sustainable” rules took significant study, sometimes requiring a Small Business Economic Impact Statement (SBEIS), to arrive at the CR-102 stage. Filing a CR-101 established a public comment period during which the agency reviews and/or responds to public input.
    • Hoffman fielded several questions about the rulemaking project:
      • Shawn DeNae Wagenseller asked if licensees could expect rules “sometime in the middle of next year.” Hoffman responded it was a “hard question” due to not knowing “how these rules are going to roll out.” She stressed that while she hoped to have an economic impact statement by the “end of June” and new rules prepared by autumn, she still had to compare the changes and complete an “intense and thorough” review of “how these rules are going to impact all [stakeholders].” Hoffman also promised a “phase in” period for the new rules for the market to adjust.
      • Jim MacRae inquired whether the draft rules included input provided by stakeholders from October. Hoffman said the draft reflected “internal discussion” as well as “comments that were received after we filed the CR-101.” She explained the draft rules hadn’t been changed since March 21st.
      • Jedidiah Haney said the rule timeline looked different: “Can you elaborate a little bit further on the timeline for pesticides and heavy metals, specifically?” Hoffman answered that the level of stakeholder and economic feedback she received “leads me to believe this is going to take a while.” Following up, Haney asked if the timeline for the workgroup study in HB 2052 impacted rulemaking, although the bill was not law at that time. Hoffman replied that the agency wasn’t factoring that into their analysis. When Haney pointed to the potential for “back to back” rule changes on the same topic, Cannabis Examiner Manager Kendra Hodgson said “we’re not anticipating that those rules will change what is required for testing, instead of the standards for testing.” Hodgson said WSLCB expected the study to “work in concert” with their changes, and that the workgroup would look at “standards for doing the tests” for pesticides as opposed to agency rulemaking on “the testing thresholds or testing requirements.”
    • Staff explained that the forum agenda allotted 30 minutes for comments on each section of proposed changes in RCWs 314-55-101, 314-55-102, and 314-55-1025.
  • Participants shared feedback regarding the draft rules and responded to one another’s comments.
    • Shawn DeNae Wagenseller, Founder and CEO of Washington Bud Company:
      • On 314-55-101, Wagenseller said she’d previously had cannabis samples collected by Michelle Sexton, a naturopathic doctor specializing in the endocannabinoid system, and found a “six point spread” between the tetrahydrocannabinol (THC) percentage of a single branch, where the top bud always had more THC than lower on a branch, regardless of cultivar. She was less concerned with lot size than being able to send in a plant’s “best bud” instead of the current process of “split up the lot in four pieces and pick a gram from each lot” for testing. Wagenseller was also unimpressed by potency labeling with THC content listed to the hundredths-of-a-percent and recommended labeling a range of THC potency on products instead. Such a policy would minimize “gaming” and “the need to have high percentages” and suggested ranges of “less than 10%, 10% to 14%, 14% to 18%, and over 18%.” She suggested consumers would have difficulty differentiating between an intoxication from cannabis with 18% or 27% THC (audio – 4m).
      • On 314-55-102, she emphasized the need for greater availability of medically compliant products. She pushed for an emergency rule for pesticide and heavy metals testing, which she said her company had been doing “for over a year now.” She urged the agency to lift the THC limit for patients and raise amounts they could buy to one pound: “Let patients and doctors figure out what the patients need.” Wagenseller added that labeling should include ingredients like extra terpenes (audio – 3m).
      • On 314-55-1025, she said that licensees needed to be able to “work on one list” of prohibited chemicals, rather than separate ones for different agencies or labs. Wagenseller responded to other comments saying she supported “harvest sizes for testing” for all cultivars in a grow area in a single pesticide and heavy metal test, rather than only testing cultivars intended to be medically compliant. She said “honor system” testing should be backed up with “random testing that [Washington] is already supposed to be doing.” Finally, she encouraged another emergency rule requiring testing for any product currently labeled as pesticide-free (audio – 3m).
    • Dani Luce, CEO of G.O.A.T. Labs and a member of the Laboratory Guild at this time:
      • On 314-55-101, Luce told those gathered that the Guild’s concern was “if you take the five pound lots and increase it, double it to ten pound lots, it’s going to, in fact, cut the revenue stream [for labs] in half.” She continued by saying that of 13 accredited labs in Washington, 6 had equipment that would cost over $1 million to get running, and that labs turned little profit under the current regime. Luce’s recommendations were for incremental changes, and care in balancing the costs of independent lab operation and staffing with the costs to producers for sample testing (audio – 4m).
    • Jeff Doughty, CEO and Chemistry Manager for Capitol Analysis, and a member of the Laboratory Guild at this time:
      • On 314-55-101, Doughty said that “without sampling we can’t say there’s a chain-of-custody in place, and without a chain-of-custody we can’t say that the certificate of analysis is representative of the lot that we’re analyzing.” He echoed Luce’s comments on the economics, but stated that he’d “talk to the scientific side.” Doughty explained there was a “natural variation” in cannabis lots, without homogenization there was a 27% relative standard deviation, with homogenization that lowered to “about 2%.” He reasoned “natural variation” could be controlled but, “I can say definitively that an increase in lot size will make the existing problems that we have with lab variations worse.” He suggested the state not increase lot size for potency and instead study “variation in pesticides and heavy metals.” He called for “data-driven policy” based on study by the labs themselves. Doughty said the labs can “create reporting ranges but they should be based off of the equipment each lab is using and based off the data they’re reporting.” This would facilitate assigned performance ranges for each lab “based off of how good of science they’re using” (audio – 4m).
      • On 314-55-102, he raised concerns about “dry weight corrections” for cannabis lots and “discrepancy” in the rules. Doughty said that while labs were expected to test samples as-is when they arrive, he claimed a majority of labs were drying samples further, impacting their weight. This comment drew audible disagreement from attendees. He went on, saying “micro and myco [toxins] aren’t good enough” and that required tests were too narrow. “The former blanket testing of yeast and mold was too much,” Doughty argued, but current protocols weren’t sufficient. He called for a more robust traceability system that logged terpenes and cannabinoids beyond THC. He seconded calls for “end-point testing” of products, saying mycotoxin checks happened for cannabis flower but not the edibles the flower is infused into, which he called a “main vector” of public safety concern. He said pesticides in consumable products were a national concern, and required sound scientific levels as opposed to “arbitrary” ones. Doughty finally called for more freedom to conduct research and development, saying labs were too constricted in what outside testing they could perform (audio – 3m).
      • On 314-55-1025, he supported comments for testing “in matrix,” saying it was considerably different than testing in solvent: “The plant itself interferes with a lot of the tests that we do.” He asked for stages with blind and non-blind testing which could be used to create a range to indicate a lab’s overall effectiveness. Doughty observed that labs scheduled their own proficiency exams, a practice he discouraged because ultimately “we have to perform all of these tests with the same precision and accuracy” regardless of product. His final comment was that the industry needed “defensible data” that could stand up in court in addition to the lawful ability to use said data (audio – 3m).
    • Amber Wise, Scientific Director for Medicine Creek Analytics, Laboratory Guild member, and Co-Chair of the Cannabis Alliance Science and Standards Committee at this time:
      • On 314-55-101, Wise called for testing end product samples and shared the Cannabis Alliance’s feedback on WSLCB’s concepts for QA testing.  Wise claimed the California Code on cannabis testing focused on end product testing. She also said a “functioning traceability system” was key to transparency in all areas (audio – 2m).
        • See Cannabis Observer’s coverage of Traceability Advisory Committee meetings since this session on April 11th, May 9th, and June 13th.
      • On 314-55-102, Wise began by critiquing “unit and language usage” saying “cannabinoid concentration/profile” was more accurate than “potency.” She was similarly critical of the terms “psychoactive” and “derivatives” as she believed they were often used incorrectly. Wise further called for “limits of detection and limits of quantification” to show numbers reported were “relevant to your instrumentation and your methods.” She said WSLCB’s lab workgroup was important and pointed out potential flaws in the draft language (audio – 3m).
      • On 314-55-1025, Wise told the group that it was important for proficiency testing to be in matrix, where diluted solutions are run through instrumentation “and then you calculate the number that comes out.” Seconding Doughty’s call, she said ideal proficiency tests would be blind. Wise went on to ask if the agreement WSLCB had with the Washington State Department of Agriculture (WSDA) could fund third party testing under discussion. Her final comment was for a “very clear recall procedure and enforcement” for product failures (audio – 3m).
    • Lukas Hunter, Director of Compliance for Harmony Farms:
      • On 314-55-101, Hunter praised the inclusion of terpenes in the recent packaging and labeling rules but noted there wasn’t a definition of terpenes in administrative code. He called for a re-testing process because “false positives are something this industry is plagued with” and asked that re-tested batches be considered during adjudication (audio – 4m).
    • Camilla Paine, Quality Assurance Manager at Praxis Laboratory at this time:
      • On 314-55-101, Paine explained that she liked “laboratory discretion to fail samples” and thought increased ability to do so in Leaf Data Systems would serve the public. She disliked the lot size increase as it didn’t “add anything to consumer protection” but did support an increase in the QA sample size. Comparing the state’s sample ratio with California, Paine observed, “As it is, a five gram sample for a ten pound lot is not nearly representative enough and could potentially cause issues.” She recommended “at least ten grams” for QA testing from ten pound lots (audio – 2m).
      • On 314-55-102, she liked the “consideration” given to small producers and processors regarding pesticide and heavy metals testing, and suggested a “lead time” for implemented changes of six months to a year. Paine then advocated for labs to define their own “scope of testing” and “not put a limit on subcontracting.” She encouraged “harvest-level testing” for pesticides and heavy metals, while concentrate regulations should look at flower tests for potential concentrations of prohibited chemicals and retest when warranted. Paine asked for “pesticide limits based on inhaled versus ingested risk levels” and that labs shouldn’t be limited to only cannabis testing outlined in this RCW section and 314-55-108. She agreed with Wise’s language usage suggestion in favor of “cannabis concentration” instead of “potency.” Paine concluded that the sampling system in place just needed to be enforced (audio – 3m).
      • On 314-55-1025, she impressed upon the group the need for in matrix proficiency testing, and suggested that after three successful proficiency tests a lab only be required to pass annually. “[We] don’t gain any benefits towards consumer confidence” by expecting good labs to be continuously evaluated (audio – 1m).
    • Kyle Capizzi from the Cannabis Alliance Science and Standards Committee: 
      • On 314-55-101, Capizzi reminded staff of feedback the Cannabis Alliance provided and referred to several items in it. He began by saying changes to sampling and testing impacted lab and producer/processor costs and should be reflected in economic impact statements. Capizzi pointed to the Cannabis Science Task Force in HB 2052 as a potential consideration for any new standards put forward. He supported third party testing as the current system had “potential for including biased samples.” On sample size, Capizzi argued for eight grams of flower, five of concentrates as minimums needed to perform tests including pesticides and heavy metals (audio – 4m).
      • On 314-55-102, he referred to item five in the Alliance feedback on topics such as cannabinoid testing, “batch” definition, homogenization of concentrate batches, additives (not limited to terpenes), or laboratory proficiency. Capizzi called them a “sensible way of handling a moving market in a uniform manner” (audio – 4m).
    • Jim MacRae of Straight Line Analytics:
      • On 314-55-101, MacRae spoke to QA rules as “among some of the most important that you can do” because it addressed consumer trust. He supported stronger language on sample representativeness and consequences for violating the chain of custody. MacRae was supportive of third party sampling, but said “this really is a cost/benefit thing at its core.” He warned that larger lots per sample endangered consumer safety, and that smaller lot sizes with increased testing is “more money from the farmers or whoever paid for it, for testing which will increase wholesale cost” (audio – 3m).
      • On 314-55-102, he recommended including a limited terpene subset in reporting, but recommended against a “total terpenes” classification. MacRae said MJ Freeway had “deprecated” the terpene reporting function in traceability “in a desperate effort to get something delivered before the end of the year” but the state should keep it in any traceability system. He said QA rule changes from 2017 were damaging to consumer safety and suggested removing an “and” between testing “moisture content and water activity” as it was causing fewer failed samples. He also called for the re-inclusion of yeast and mold testing. Finally, MacRae advocated for more stringent testing for edibles beyond potency (audio – 4m).
      • On 314-55-1025, he told those attending that if farmers pick samples “there’s an intrinsic potential for bias” and called for chains of custody for samples by those without “potential profit motives.” MacRae went on to call for WSLCB to use its current resources for the minimum number of monthly tests WSDA had been contracted for, but hadn’t utilized. He urged blind or randomized testing to try and catch labs inflating cannabinoid concentrations or other results. Lastly, he said the agency should strengthen the product recall process “and use it” (audio – 3m).
    • Jedidiah Haney, Executive Director of the Laboratory Guild: 
      • On 314-55-101, he began by saying he didn’t like the lot size changes. Haney asked for laboratory information management systems (LIMS) to be considered in rulemaking as it was “our traceability system for labs” independent of Leaf Data Systems. Haney suggested adding harvest date back onto product labels to require re-testing when products were not stored to ASTM standards. He also advocated for resampling non-shelf stable infused edibles every 90 days, and trained third party validation of any failed tests inclusive of chain-of-custody review (audio – 4m).
      • On 314-55-102, Haney focused on the Department of Health’s “substandard” language for pesticide testing of medically compliant products, and expressed skepticism about applying it as written more broadly (audio – 2m).
      • On 314-55-1025, he stated that “bad actors are diluting the credibility of quality assurance.” Absent penalties and blind testing, Haney feared further “abuse of this process.” Haney stated it was possible that “an individual can start a lab, falsify data, capture market share, get caught many months or a year later, get shut down only to start up again” under a new name. He felt this allegedly hypothetical possibility made blind proficiency testing more important (audio – 2m).
    • Crystal Oliver, Executive Director of the Washington SunGrowers Industry Association (WSIA): 
      • On 314-55-101, Oliver explained that farmers “cannot afford another increase in operating costs whatsoever” and that producers like her would prefer harvest-level as opposed to lot testing. She said 2017 QA testing changes led to a “significant” increase in grower costs despite that rulemaking project’s small business economic impact statement. She said any advisory group should include farmers to avoid a “fox watching the hen house situation” where decisions consistently favored labs. Oliver also resisted requests to add harvest date back on products as it had “a disproportionate negative impact” on outdoor growers (audio – 3m).
      • On 314-55-102, she raised concerns about existing action limits in law as farmers were failing tests when using authorized pesticides as directed. She felt the pesticides shouldn’t be approved or their action limits should be lower. Oliver backed “separate standards on concentrates” based on inhalation or ingestion, and voiced fears over a “lack of competition with regards to the labs.” She added a lack of competition was already a problem for producers seeking insurance. Harvest-level testing was important to all the farms she represented (audio – 4m).
    • Thomas J. Worth from Top Shelf Cannabis:
      • On 314-55-1025, Worth said potency analysis was “marketing” and budtenders could inform customers about product strength. He said his company had begun testing its products for pesticides and felt the industry hadn’t taken sufficient action although they had been called out by the media. Worth encouraged customers to ask retailers for test certificates and supported including terpene profiles (audio – 3m).
  • Hoffman concluded the listen and learn forum by outlining upcoming steps in the process (audio – 7m).
    • She explained that staff would document and package comments to compare with the current draft rules. From there, changes would be presented to the Board.
    • Hoffman predicted draft rule availability “about a month” after the legislative session ended. Comments on those rules can be submitted to kathy.hoffman@lcb.wa.gov. Hoffman encouraged those interested to sign up for GovDelivery messages to get future updates in a timely manner.
    • A second Listen and Learn forum was scheduled for Tuesday June 25th to hear “your innovative ideas and solutions regarding reducing, or mitigating licensee impact if all marijuana produced and processed in Washington State were tested for pesticides and heavy metals” (announcement, agenda, webinar registration).
    • After hearing supportive comments on the deliberative pace and process for this rulemaking, Hoffman said it was an intentional change she made after joining the agency last year. She hoped it would give licensees time to adjust, saying “the table’s big enough for all of us. So let’s just keep adding chairs until we get it right.” 

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