WSDA - Public Hearing - Cannabis Testing Lab Quality Standards
(December 28, 2023) - Summary

2023-12-28 - WSDA - Public Hearing - Cannabis Testing Lab Quality Standards - Summary - Takeaways
[ Event Details ]

Lab representatives and other stakeholders pointed out discrepancies, redundancies, and costs related to proposed lab quality standards leading staff to ultimately choose to rework the rules.

Here are some observations from the Thursday December 28th Washington State Department of Agriculture (WSDA) public hearing on the Cannabis Testing Lab Quality Standards rulemaking project.

My top 4 takeaways:

  • WSDA leaders introduced themselves and the topic of lab quality standards (audio - 5m).
    • Agency Rules Coordinator Gloriann Robinson said the hearing involved “the proposed establishment of chapter 6-16-309 of the Washington Administrative Code [WAC], the cannabis laboratory accreditation standards program.”
      • Robinson outlined the WSDA rulemaking process, stating a recording of the meeting would be public record, and a summary of any comments received “will be compiled and presented to the Director of the Department of Agriculture in the form of a hearing officer report.” If they moved ahead with rules, she indicated a concise explanatory statement would be published with a description of the reasons for adding the rules.
    • Cannabis Program Manager Trecia Ehrlich provided a technical report, and described how HB 1859 “created an interagency coordination team for cannabis laboratory quality standards” helmed by WSDA personnel—the group subsequently renamed as CLASP—and ”the bill also required WSDA to establish and maintain cannabis testing laboratory quality standards by rule.” Such standards were to include “approved methods for testing cannabis for compliance with product standards established by rule by the LCB or the DOH; method…validation protocols and performance measures; and criteria applied to testing of cannabis products.” As drafted, she said the proposed rules would create a “new chapter of rule, which [was] intended to expand the laboratory quality standards first created by” WSLCB “for the purpose of enhancing the integrity of cannabis testing in Washington State.” Ehrlich then outlined several of the effects of the new rule language:
      • Proposed WAC “chapter 16-309…will include creating education and training requirements for laboratory personnel, which depend on position or testing responsibilities”
      • “WACs 16-309-040 through 080, requiring standard operating procedures and SOP criteria for all laboratory testing”
      • “WAC 16-309-090, requiring sampling and homogenization protocols for sample preparation”
      • “WAC 16-309-100 requiring security and safety protocols for the laboratory and for the laboratory staff”
      • “WAC 16-309-110 requiring the use of quality control and assurance protocols for laboratory testing”
      • “WAC 16-309-120 establishing facilities and equipment maintenance criteria for the laboratory”
      • “WAC 16-309-130 establishing method performance criteria for laboratory testing”
      • “WAC 16-309-140 establishing quality control and method performance criteria specific to each required test, water activity testing, cannabinoid concentration analysis, foreign matter inspection…microbiological screening, residual solvent screening, mycotoxin screening, pesticides screening, and heavy metal screening”
      • “WACs 16-309-150 through 16-309-220 establishing required standardized testing method procedures for cannabinoid concentration analysis, residual solvent screening, and heavy metal screening”
      • “WACs 16-309-160, 309-190, and 309-220 establishing quality control and method performance criteria for analyte testing outside of product testing requirements as established by the WSLCB”
      • “WAC 16-309-230 creating laboratory computers and information systems requirements”
      • “WAC 16-309-240 establishing method validation criteria for laboratory Testing”
      • “WAC 16-309-250 requiring proficiency testing by ;laboratories as per the standards of the accrediting authority”
      • “WAC 16-309-260 establishing certificate of analysis report requirements”
      • “WAC 16-309-270 establishing procurement protocols for the selection and purchasing of services and supplies for the laboratory”
      • “WAC 16-309-280 in establishing sample subcontracting requirements for third-party services WAC 16-309-290.”
    • Ehrlich added that the rules had been designed “in collaboration with the Washington State Liquor and Cannabis Board and the Department of Health. As such both agencies [were] heavily involved with this rule since [accreditation] will potentially be overseen by the Washington State Department of Ecology, WSDA will be coordinating with” that department.
    • Robinson reviewed some guidelines for providing oral comments, and stated that she might ask follow up questions if any remarks needed clarification. She noted written comments on the proposed rules should be sent to WSDARulesComments@agr.wa.gov before opening the floor to public comments (audio - 3m).
  • Comments from stakeholders, including several staffers from Confidence Analytics, talked about gaps in rule language and the prescribed standard method documents, enforcement mechanisms to increase certificate of analysis (COA) accuracy, the ability of labs to test patient samples, and other topics.
    • Harmony Farms Director of Compliance and Government Affairs Lukas Hunter read the rules as providing a “chain of custody” among licensees and labs, and wondered “is there an allowance for civilians to be able to submit lab tests,” particularly “medical cannabis patients or individuals that may be concerned about the quality of the product that they're receiving.” He had concerns that the “person delivering those samples would have to have a manifest” which wouldn’t be available to the general public. Robinson noted that staff couldn’t answer questions in a hearing, but concerns would be addressed in the concise explanatory statement (audio - 2m).
      • Ehrlich subsequently responded that the rules were focused on required compliance testing and weren’t intended to bar an individual from having a lab test their cannabis sample (audio - 1m).
    • Jim MacRae, Straight Line Analytics, addressed what cannabinoids would have testing accreditation and the need for enforcement mechanisms to stop bad actors. He inquired if staff was planning on adding accreditations for any of the minor cannabinoids other than…delta-9-THC, THCa [tetrahydrocannabinol acid], CBD [cannabidiol], CBDa that are in WAC currently.” MacRae advised finding “examples of existing testing within the regulated market for some of the labs.” He further felt rules should incorporate “an accrediting capability for terpenes.” Having spent years “looking at the data that are spit out by the regulated labs critically, and based on some early observations in the first year of the regulated market,” MacRae found it “painfully apparent” that rules for lab standards needed to be monitored and enforcement against “either inflated cannabinoid and/or terpene levels, and/or lower quality assurance safety failure rates than one might expect” (audio - 6m):
      • He acknowledged WSLCB had closed “a couple of labs…but the behavior’s still rampant.” MacRae believed defining the process should feature continuing “accreditation that is not someone coming in,” but if officials went out “to the retail establishments” and collected end products and “test them against what the lab reported…if you start seeing variation” then regulators could “identify fraud when it exists if it's rampant, and do something about it.” This would mean “accreditation will actually translate into consumer transparency into what is actually in the product and not in the product,” he argued.
      • Ehrlich cautioned that she couldn’t address specific accreditation questions as DOE was set to take on that authority while noting there was WSDA requests legislation in the works which might impact the transition (audio - <1m).
    • Beth Cantrell, Confidence Analytics Chief Operating Officer, asked about “the best way to provide feedback regarding the CLASP methods that are part of this regulation. It's not entirely clear the best way for us to provide any formal feedback on those.” She also encouraged “some guidance surrounding variations between the CLASP methods and the actual regulatory text,” as she felt they “they deviate from one another” in the drafted rules and she wanted to understand whether policy or regulation took precedence (audio - 2m).
      • Ehrlich encouraged sending feedback to her team via cannabis@agr.wa.gov, emphasizing the methods were a “WSDA publication, so we have the capacity to edit those” (audio - 1m).
    • Tania Sasaki, Confidence Analytics Chief Science Officer, pointed out the rule language said “that any analyte that is not a part of…the CLASP test method, that they still have to meet all the accreditation…validation standards and performance standards of those methods, but that we would have to report them separately and they would be reported outside the scope of accreditation.” She felt any lab expected “to have those analytes perform to the same standards as the accredited analyte, then they should not be excluded from that scope of accreditation because accreditors can verify…our validation data, the performance data.” Sasaki asked for “that part of the rule [to] be reviewed, and that [analytes] be included in the scope” (audio - 2m).
    • Shannon Stevens, Confidence Analytics Lab Director, said mention of the CLASP methods in the rules had led them to compare the documents in detail and develop “a spreadsheet of guidance that's contained within the draft rules and how that compares to the guidance on” the methods from CLASP. She said they were “finding a lot of discrepancies, conflicts really, between standards that are stated in the draft rules versus in those methods.” Stevens promised to provide written responses, “but is there a timeline by which the feedback on CLASP methods needs to be provided?” She stressed her team wanted to know “especially given that three of the CLASP methods, the threeregarding pesticidetesting standards, were not provided at the WSDA site and they were ultimately emailed to us,” as “we really need more time to go through those” (audio - 5m).
      • Additionally, Stevens noted the “acceptance criteria” outlined in the rule wording and methods had “control accuracy ranges that deviate from that, and even within those methods.” Her example was “the cannabinoid analysis method” which had “four different accuracy ranges listed out depending on the control type,” and she wanted to see draft rules with “overriding standards that are simplified… not just the accuracy range requirements, but the nature and number of controls that are required per preparation batch.” Stevens noted there were “control types defined in the definitions section, but then…those terms are not used in the draft rule,” while other controls mentioned in the draft weren’t defined. “What I would really love to see in a draft rule,” she concluded, was “a concise, specific, and universal standard for the number of controls that are required, the nature of those controls, and the acceptance criteria for them.”
      • Robinson noted since the method documents were going to be part of the rule language the comment period would end that day at 5pm. “So while I'm sure the program will always accept your feedback to the methods themselves” during future iterations, she said “because the rule language adopts the methods, anytime that methods document is adopted we would go through the rulemaking process again to adopt the new version of the methods.”
        • Cannabis Observer reached out for clarification if standard method policy documents could be more generally referenced in rule to avoid subsequent rulemaking projects to adopt revisions. Ehrlich indicated department staff were “exploring the best ways to make methods available…while also considering ways to allow for more flexibility – both in our rules, and for laboratories.”
    • Confidence Analytics Quality Program Manager Cristi Crofton remarked that there were “a lot of discrepancies, redundancies that are listed in…many of the CLASP methods.” She didn’t feel the documents were “to a point where they could move forward as a fully developed method,” as it looked “like there's a lot of rough draft work in them.” Crofton called for a “lengthier review process here before fully transitioning to those kinds of methods” (audio - 2m).
    • MacRae spoke again to call attention to the number of lab staff finding problems in methods which had only recently been shared. Highlighting that he had no financial interest in the rules, he argued if laboratory representatives had little time to review the methods “I don't know what deadline you're working on here, but…you really should allow them beyond the close of business today, time to absorb what I imagine are fairly deep, complex documents that are important to this process, and they have more expertise…given the ten years that they've been involved in this game, than anybody that's writing standards.” Absent a “real date constraint on getting those rules in there,” MacRae questioned the “optics” of not giving stakeholders more notice on something related to “consumer safety” (audio - 3m).
      • Robinson clarified whether MacRae was asking when laboratory staff were given the methods document. He agreed, and asked to specifically address any of the materials Confidence Analytics staff had alleged were only recently provided.
      • Ehrlich said she felt "we'll need to provide more time for the pesticide methods, we can talk about it later" (audio - 1m).
    • Crofton spoke up to say they’d received the methods in question on December 22nd. MacRae joked that reviewing control methods to offer input to state agencies sounded like “a nice way to spend Christmas weekend” (audio - 1m).
      • The document metadata for the pesticide methods indicated they were created on December 21st, the Thursday before a holiday weekend. Other methods were created on November 16th and 29th.
    • Stevens shared that her team had “really substantial concerns about costs, especially related to the control requirements and the limited sizes for preparation batches.” The cannabinoid method had standards restricted “as to the concentrations that can be provided since we are not a [US Drug Enforcement Administration] DEA-exempt organization,” she commented, urging more review with an “understanding of the types of volumes that we typically test” (audio - 4m).
      • For Confidence Analytics, she estimated they handled “approximately 2,000 samples in a month” and rules where her team was “limited to 20 samples and those batches each requiring their own controls to be spiked in the extraction tubes, we're looking at consuming thousands of dollars—potentially per day—in cannabinoid standards alone to meet that.” Stevens asserted, “the more of those controls that could be spiked in a vial can really help us limit our consumption of those standards.” Expecting that some controls would go through the extraction and sample preparation process, she said their lab had between fifty and a hundred samples each day exposed to the “same equipment, the same reagents, the same preparation procedures.”
      • Stevens also regarded the rules differentiating samples “per matrix, really complicates, and [was] going to heavily increase the control requirements.” She advised “for methods that have been validated to matrix effects, and have demonstrated that they perform similarly amongst a variety of cannabis matrices” for differing cannabis products like edibles or topicals, “that different matrices be allowed to combine within a preparation batch.” Stevens asked staff to “please look at the control requirements considering the facts that cannabis labs receive a variety of matrices every day and may be testing a large volume of samples every day.”
    • Sasaki reiterated the need to identify different control types and the corresponding methods, along with “using consistent language” as important. She indicated that some CLASP methods had been posted early in December, but the methods related to pesticides weren’t available until December 22nd. “It should be noted that each of those CLASP methods has probably at least three documents,” yet “our full-time job obviously isn't reviewing these documents.” Sasaki seconded calls for a longer comment period on the methods (audio - 3m).
    • Jay Burns, Treeline Analytics Lab Director, explained that he’d submitted supportive written comments that morning, but he also had cost concerns that “the economic impact statement wasn't as robust as it could have been in looking at some of the different options to reduce cost.” He’d looked at CLASP methods and commented on all except the pesticides, “it would be nice to have a little more time, but… the pesticide one is actually…in our opinion one of the…best ones, it's pretty straightforward” (audio - 1m).
    • Hunter echoed the concerns others had raised, particularly around costs and economic repercussions on labs. As the number of businesses had shrunk from 14 labs in 2018 to seven, care had to be taken to keep cannabis testing viable (audio - 2m).
    • Stevens also supported guidance for labs “who will ultimately want to validate their own methods as alternatives to the prescribed methods.” She understood that labs had to “formally request to validate their own method, and then to submit their proposed…methodology for such a validation, and have it approved by WSDA.” She asked for more guidance, especially when methods “deviate from the language in the rules” (audio - 2m).
  • By the time staff wrapped up the hearing, it was clear that further work was needed and a follow up email was sent explaining WSDA personnel would take more time to refine the proposed rules and standard methods.
    • Robinson repeated some of the next steps in preparing responses to the comments they’d heard for an official hearing record (audio - 1m).
    • Nick Mosely, Confidence Analytics CEO, asked when stakeholders could expect to see a response from WSDA staff. Robinson expected that would be part of a concise explanatory statement. Mosely then asked for clarification as to whether a supplemental CR-102 would be filed if there were additional changes to the rule language, and if that would delay implementation. Robinson confirmed “substantive changes” to the draft rules required a supplemental CR-102, and would prompt a new comment period and public hearing that would push back the implementation of the rules (audio - 2m).
    • Robinson thanked participants and staff, and mentioned that written comments on the rules should be submitted to WSDARulesComments@agr.wa.gov, or mailed to her at the WSDA Olympia office (audio - 1m).
    • After the hearing concluded, Ehrlich sent out an email response that indicated staff would indeed file a supplemental CR-102, delaying the rule implementation but allowing for more refined language from staff and additional feedback from stakeholders. She predicted changes would be made to the methods document and welcomed “any specific feedback you may have on the methods to be sent our way…We would greatly appreciate any feedback you can provide (in particular on methods) before Friday, January 5th if possible.” While working to incorporate the insights made by attendees, she stressed “our goal is not to extend our deadline out too far, so you should expect a notice for the supplemental CR-102 to come your way in the coming weeks, after which, we will have another public hearing.”

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