WSDA - Webinar - Cannabis Testing Lab Accreditation
(March 14, 2024) - Summary

2024-03-14 - WSDA - Webinar - Cannabis Testing Lab Accreditation - Summary - Takeaways
[ Event Details ]

Officials outlined a transition period to take on accreditation authority in parallel with revising standards, including method approval and when enforcement of new standards would start.

Here are some observations from the Thursday March 14th Washington State Department of Agriculture (WSDA) webinar on the Cannabis Testing Lab Accreditation rulemaking project.

My top 5 takeaways:

  • Trecia Ehrlich, WSDA Cannabis Programs Manager, offered remarks on the background of the project and then described an expedited rulemaking timeline.
    • Ehrlich said with the legislation now law, WSDA officials had “to create rules by July 1st for an accreditation program, and it means that we will become the accrediting authority over laboratories.” She encouraged empathy for laboratories who “had one vision of what was going to happen for the last five or six years and then at seemingly the very last minute this year that changed, we decided to run a bill to take over accreditation.” WSDA leaders had done this, she argued, “because we thought it was what was best for everyone, really. We thought it was best for us. We thought it was best for Ecology. We thought it would be best for the labs. We thought it would be best for the industry. That's why we wrote it” (audio - 6m).
      • Mentioning the “short transition time” for regulators and the industry alike, Ehrlich brought up the draft rule text and acknowledged that “we did not include fees in the draft because we're still analyzing them. The fees will be embedded into rule and they're going to be extremely similar. I don't want to say identical to [WSLCB accreditation vendor] RJ Lee because there might be some variances, but extremely similar to what you are paying now...within a few percentage points.” Her plan was to complete those numbers the following week and send out a revised draft.
      • Ehrlich explained the timeline for getting accreditation rules in place, identifying:
        • April 9th: public hearing for the Cannabis Testing Lab Quality Standards rulemaking project, which the Cannabis Testing Lab Accreditation project supplements. Department adoption of that effort was expected on April 16th.
        • April 10th: the CR-105, an expedited rulemaking filing, would be a “much, much faster process” and include “a pre-CR-105 meeting…on April 10th, less than one month from today.”
        • April 17th: the CR-105 would be filed with the Washington State Office of the Code Reviser (WA OCR).
        • June 18th: the earliest possible adoption date.
      • The July 1st deadline to transfer accreditation authority would be narrowly met under this schedule, Ehrlich indicated. “We don't have a ton of time to make major changes,” she admitted, but “this is not the say-all and end-all, we probably will open the rules within one to two years,” she told the group.
    • In addition to adopting expedited rules, Ehrlich spoke to the transition timeline for cannabis labs to become accredited through WSDA. “It is our plan to provide laboratories with slightly over six months to come into compliance,” she said, giving them “until December 31st of 2024 to come into compliance with [WAC] 16-309.” Ehlich confirmed this timeline would be explicitly in rule, “the delayed enforcement of 16-309 is actually in [WAC] 16-310,” although the standards for accreditation would be in effect at that time. “So now the second question that any lab would ask is ‘so what happens between July 1st and December 31st?’” (audio - 7m)
      • Audits occurring in this timeframe would “be audited based on the standard set forth in WAC 314-55, just as you have been for all the last few years… it just so happens to be that all of the labs will be accredited between…June and December of 2024.”
      • “However, on January 1st of 2025 you will be required to be fully in compliance with 16-310…and we will be able to check your data, come into your lab, request data as described in the auditing rule set 16-310 to ensure that you are up to date even prior to your next accreditation or audit, and if you are found out of compliance you can…receive any risk related to non-compliance,” like revocation or suspension.
      • There was a dialogue underway with WSLCB staff so that WSDA could “continue the RJ Lee contract” so that “between now and December 31st, RJ Lee will continue to conduct your audits” along with WSDA participation. This would ensure that expectations for labs weren’t different based on when their audit was scheduled, and “we recognize that people are paying audit and accreditation fees this year, and we…don't want to force you to pay two accreditation fees within one calendar year.” Additionally, since the checklists and procedures were in place and familiar to RJ Lee staff, WSDA personnel could avoid dedicating time and materials to accredit to standards being phased out.
  • Questions about ensuring lab compliance with new standards in 2025; accreditation methods and how discrepancies would be handled; lab outsourcing; and the potential for fraud were raised in the meeting.
    • Nick Mosely, Confidence Analytics CEO, clarified the different WSDA rulemaking project schedules for lab standards and accreditation (audio - 1m).
    • Amber Wise, Medicine Creek Analytics Science Director, wanted to understand how WSDA officials would be ensuring lab compliance by January 1st,” as she felt there were “a lot of reservations” given the complex timelines. Ehrlich explained that WSDA staff presence during audits using the existing standards in 2024 meant “we will have a physical presence in the lab and be able to see where labs are currently at, and I think it will become apparent through that process if there are labs that are quite far from the standard.” Contrasting the private contractor RJ Lee based in Pennsylvania while “we are operating under public funding in the State of Washington,” WSDA authorities would have ample access to oversee labs. “You are not the only person with that concern,” she added, calling the concern “real” (audio - 2m).
    • Lara Kaminsky, The Cannabis Alliance Government Affairs Liaison and Confidence Analytics Program Director, wanted to know whether WSDA staff planned to start visiting labs in January 2025 to check for compliance. Ehrlich anticipated they would visit labs in a “somewhat random” pattern starting in 2025. Most labs would be checked “prior to any auditing,” but they were trying to respect a pre-existing schedule for labs. She believed department staff were striking a balance between lab compliance and not trying to mandate additional costs, or create “undue burden” for labs as businesses. “If you need to hire a new chemist because of the standard - I've had to hire a chemist, it took me six months, so I want to provide that reciprocity to the labs,” Ehrlich commented (audio - 3m).
      • Kaminsky posed a hypothetical about a lab not prepared or staffed to meet standards, with Ehrlich finding they wouldn’t “be able to perform those tests” (audio - 1m).
    • Mosely suggested he had a “similar concern” to Kaminsky that labs were “expected to follow the standards without having been accredited to the standards.” He did appreciate that WSDA staff would “shadow” the accreditation process in 2024 and “engage in off-cycle surveillance.” Mosely regarded accreditation as creating “certainty” around a lab’s capability, as well as an “opportunity for the accreditor to coach the lab on what it takes to come up to the standard and…some of the labs are going to need quite a bit of coaching…and that coaching has not taken place sufficiently.” Ehrlich replied that staff were available for coaching “right now” (audio - 5m).
      • Mosely continued, remarking that some labs “don’t know what they don’t know” and he remained troubled by “the cost of routine compliance.” He pitched “accreditation ahead of the enactment, so that we could be sure everyone really is on the same level at that time,” since the sector should avoid having labs unevenly “taking on the cost of routine compliance while other labs—knowingly, or not—are not taking on those costs because that can create an economic landscape that is unfair.”
      • Ehrlich warned that accreditation ahead of enacting new standards would lead to some labs being charged for accreditation twice within a year. Mosely felt that WSDA officials could instead extend some accreditation certifications temporarily until the department had completed the transition to being the accreditation authority. Ehrlich impressed upon him the narrow timetable for expedited rulemaking, stating she welcomed “rule structure” suggestions in writing, but had concerns about some changes since they wanted to keep the RJ Lee contract, and still considered there to be value in going into labs and seeing how they handled the existing accreditation process.
    • Cristi Crofton, Confidence Analytics Quality Program Manager, brought up ISO accreditation, stating that an initial accreditation was always different from subsequent ones. She noted ISO accreditation included a “deficiency report” which lab officials had to respond to within 30 days and potentially remedy any non-compliance over six months. She argued the rules could “use a little more grace.” Ehrlich sympathized, yet believed "all labs deserve the opportunity to come into compliance.” She cited the “imperfect” timeline for them to take on accreditation authority and asked again for changes to be submitted in writing. Ehrlich also warned they were working within budget constraints (audio - 3m).
    • Mosely indicated that in 2025 “we’ll have our first audit with CLASP. Is that going to be considered an initial accreditation, or is that a continuing accreditation?” CLASP Coordinator and WSDA Lead Chemist Dave Michaelsen answered that it would be considered a continuing accreditation. He then addressed what data would be used in initial validation, as well as the lab manual under development “that will go along with the checklist questions explaining to both the labs and the auditors what those specific rule compliance means, what do they look like, what we expect to see” (audio - 3m).
    • Mosely had looked at the draft rules and found “every year, and indefinitely, the accreditation will be an on-site audit,” whereas “our current paradigm…was like the first three years on site and then alternating surveillance after that.” Ehrlich explained that the intention of WSDA auditors was to be primarily on-site, and “an online audit would be circumstantial” (audio - 1m).
    • Then, Mosely said there were “inconsistencies, discrepancies between the rules and the methods…when those discrepancies exist, what takes precedence?” Michaelsen answered that rule language would take precedence (audio - 1m).
    • Wise posed a “logistical question,” recognizing that if a lab’s methods were approved they’d be “publicly available,” so that later-audited labs could review materials from those who went first. This “puts the labs that go up first at a much greater disadvantage, for other labs to just take all of their hard work on documents and use them as their own.” Ehrlich affirmed that materials around approved methods would be posted on the WSDA website, and labs had some control over how they were titled/credited. Once the department began accepting methods on April 16th, she anticipated labs would send in methods before 2025, but sounded uncertain if they’d be publicly posted before then (audio - 3m).
    • Shannon Stevens, Confidence Analytics Laboratory Director, posed more questions on documentation for standard methods, particularly what was required when labs were using an already approved or standard method that conflicted with rules. Michaelsen said a guide on method validation submissions was being drafted, but even if they relied on an approved method from WSDA, “it's not a validated method in their laboratory…they will have to go through the whole validation process to show that that method is functioning on their instrumentation” and submit affiliated data verifying this. Using a published method would help a lab with their standard operating procedures (SOP) document, he commented, but “it won't help them with the validation process” (audio - 5m).
      • Mosely asked if this meant labs would be expected to resolve any discrepancies between methods and rules, and that any changes to a method by lab staff would effectively create a new method which needed to be submitted to WSDA. Michaelsen noted they were looking at methods which had already been validated by federal agencies and by other state health officials outside of the particulars of the Washington state context. Even as new methods were submitted and validated, the rule language always took precedence, he added.
    • Considering the “auditing of purchase records,” Mosely asserted “the cannabinoid method for the matrix spike [was] going to be very costly” and wondered whether regulators were “planning to audit purchase records.” Ehrlich told him that was “not a part of our current accreditation rules, but again…I keep saying, like ‘put it all in writing’ just because [of] how fast, how many moving pieces we're trying to put together to make this happen right now” (audio - 4m).
      • Michaelsen agreed with the potential for “spiking” to be costly, but expressed confidence that “looking at that control, and that matrix control, and the values that are coming off of it, we’ll know whether a laboratory is purchasing that control.” Mosely had doubts about this.
      • Wise offered that “looking at the number of lot numbers that have been gone through could…serve that same purpose without looking at financial records.” By “asking how many lot numbers that you've gone through…there should absolutely be traceable inventory that is very easy to look up,” she said. Mosely agreed “that's better than nothing…but I think it's possible to purchase multiple vials from the same lot,” meaning there wouldn’t be “perfect visibility doing that way.” Ehrlich called the subject “intriguing” and encouraged written suggestions.
    • Considering other approaches to related to control spiking costs, Wise mentioned taking an “internal standard matrix spike in lieu of actual, all the cannabinoids in-matrix, using an internal standard spike before the extraction to show extraction efficiency, and then doing a post-extraction spike with the cannabinoids.” She worried that “given the incredible increase in cost to spiking all of those controls before the extraction, we're going to go through like a whole vial a day and they're very expensive.” Both Mosely and Michaelsen were receptive to this approach, with Michaelsen promising to take it back to their “group of scientists.” Verda Bio CEO Jessica Tonani offered that there was some research on that approach (audio - 2m).
    • Kaminsky asked whether audits would look at certificates of analysis (COAs) and labs outsourcing tests to one another to “compare and contrast.” Ehrlich answered that this would be within their authority, but there would need to be procedures established and potentially added in rule in which regulators “probably want to put the onus on the labs hiring out and not the labs being hired.” Wise suggested that ISO audits asked about subcontracting and requested examples of a lab’s paperwork for that (audio - 3m).
    • Jay Burns, Treeline Analytics Laboratory Director, inquired about interlaboratory proficiency tests (PT): “when we were on the PT committee [for the] Cannabis Science Task Force…we talked about these things and…for a state agency to get the samples to give out…we've found a bunch of roadblocks. I'm just curious, have you guys figured out how to do that, or is this just like ‘we want to do it and we're gonna figure it out eventually.’” Ehrlich replied that they were in a “nuts and bolts phase” and hadn’t settled on a procedure for that (audio - 2m).
    • Jim MacRae, Straightline Analytics, brought up the legal protections for WSDA in the draft language in sections 010 and 020, concerned there was an “inconsistency.” The first section indicated labs standards were “followed when testing cannabis and cannabis products under 314.55 WAC,” and MacRae said the next section on the scope reads in part, “accreditation does not guarantee validity of all analytical data submitted.” Moreover, if “your purpose is to ensure that the standards that are described there are followed when testing cannabis and cannabis products. I honestly can't see how that…purpose can be met without introducing some sort of random evaluation.” Similarly, section 030, emphasized “in the second paragraph that [WSDA] does not, by accrediting a laboratory pursuant to these rules, vouch for or warrant the accuracy of any particular work done or report issued by the laboratory.” He inferred from these statements that department officials would neither engage “with, or certainly not going to be acknowledging or dealing with the ongoing fraud that is endemic within this industry on the lab level” (audio - 7m).
      • Also concerned with accreditation during the transition period, MacRae felt some labs could get up to 11 months through 2025 meeting previous accreditation standards and continue operating as others would have to meet those requirements earlier in the year. Ehrlich responded that this latter concern had been raised and was covered earlier in the discussion. She acknowledged it was “not a perfect transition plan," but officials would be able to randomly visit and inspect a lab any time in 2025 to see if they meet the new standards.
      • Ehrlich felt the legal language in question was “transferred from Ecology drafts and pretty standard in any kind of government accreditation program for the legal protection of the accreditor to just name that we are not the laboratory. We accredit them, but we cannot be responsible for every single data point that they produce…I don't think our lawyers will let us get away with removing that one.”
    • Staying focused on laboratory fraud, MacRae mentioned section 180 on “revoking or suspending accreditation,” wondering “if a very good quantitative case was put before them that a lab was fraudulently misrepresenting the results in the product that it was testing, that anything in here could lead to the department actually suspending and revoking the accreditation of the offending lab” (audio - 5m).
      • Ehrlich’s first impression was that if they couldn’t meet standards they wouldn’t be accredited, but MacRae suggested that labs were only required to pass accreditation tests.
      • Michaelsen said subsection (3)(f) required labs to produce “accurate and defensible analytical data as one of the possibilities it deals with. If they are putting out incorrect or improper data, that is one of the issues that can put them at risk” for suspension or revocation. However, MacRae argued “between the ability to do something to be proficient, and the actual doing of that thing or expressing proficiency when one is doing commercial testing is the issue and that's the issue that was raised in December” during the public hearing on lab standards.
      • Ehrlich remained confident WSDA would have access to lab data outside of their audit “and review data and revoke or suspending accreditation based on falsification, otherwise found.” She further pointed to other wording on labs being “criminally negligent…there are kind of multitude of reasons and pretty broad scope there.”
  • Ehrlich took time to speak to the passage of HB 1453 (“Providing a [37% excise] tax exemption for medical cannabis patients”) and the potential to incorporate heavy metals testing into all cannabis products (audio - 5m).
    • “Maybe you think as labs [HB 1453] doesn't impact you, but I think it does,” stated Ehrlich. She felt “between 1453 passing and…the fact that the LCB is hearing a proposal to incorporate heavy metals testing into everything” that there should be an opportunity for ideas “about how we could add integrity to that through the auditing process or potentially through rule.” Ehrlich believed “there are ways procedurally that we could operate as a team, like to make sure that if someone's… cross-referencing a lab, they're actually utilizing them.” She was especially looking for improvements “to the benefit of medical patients and acknowledgment around the future of metals testing.”
    • Cannabis Alliance Executive Director Caitlein Ryan appreciated Ehrlich broaching the subject. She relayed how patients had said “if there is cross-referencing and that heavy metals test, that that be appended rather than just referenced so that folks can actually see who did that heavy metal test…in case they wanted to do any follow-up on the back end.” Ryan indicated cross-referencing was noted on COAs, “but I think folks are wanting a little bit more obvious transparency.” Ehrlich saw that more as part of the “[cannabis testing lab] standard rules” but would consider it.
    • Mosely explained that WSDA rules for referencing were “a lot more flexible” than WSLCB, but he didn’t think there was “disclosure of referencing.” Michaelsen said referencing was required under existing rules.
    • Mosely then asked whether it was possible that DOH had relevant authority around “disclosure of reports” for products complying with their medical standards. Ehrlich responded that it was on the list of topics to discuss with their counterparts at DOH during a meeting the following week, but “I don't know and it is on my mind.”
  • Future work for the transition was briefly outlined by Ehrlich, including accreditation based on in-matrix proficiency testing; training and planning for regulators; preparing procedures and method approvals; helping labs; and addressing any “unresolved issues” at the start of 2025 (audio - 3m).
    • Speaking to the “unfinished work from the Cannabis Science Task Force process, we still haven't gotten to talk about how to fix the concept of in-matrix proficiency testing.” Their rules had “removed the part that Ecology had about accrediting to matrix because I just didn't feel like we were ready to commit to those three matrix subgroups and I want to have more conversation about it.”
    • Ehrlich highlighted some key activities she envisioned in the transition timeline:
      • “These next…three months are very much embedded in us getting training, getting all of these rules out, creating a transition plan that works.
      • “The next six months will be about…putting all of our procedures in place, whether it's interlaboratory studies or even just audit paperwork, making sure that resources are available, going through method approvals, coaching labs.”
      • “And then in January…start brainstorming together about some of these…unresolved issues of ways that we can do program improvement, rule improvement, because…our silence on matters related to, like unresolved issues from the Cannabis Science Task Force [was] not” an intentional evasion of those topics, but prioritizing other parts of the transition of authority.
    • WSDA staff planned to host a second webinar on the Cannabis Testing Lab Accreditation expedited rulemaking on Wednesday March 27th and a public hearing related to proposed cannabis lab standards on April 9th.

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