DOE - Webinar - Accreditation of Cannabis Laboratories - Public Workshop
(August 10, 2023) - Summary

2023-08-10 - DOE - Webinar - Accreditation of Cannabis Laboratories - Public Workshop - Summary - Takeaways
[ Event Details ]

A second workshop to get responses to draft lab accreditation rules dealt with questions about the costs and process behind DOE staff taking over lab authority from WSLCB.

Here are some observations from the Thursday August 10th Washington State Department of Ecology (DOE) webinar workshop on the Accreditation of Cannabis Laboratories rulemaking project.

My top 3 takeaways:

  • Chemist and Rulemaking Lead Ryan Zboralski opened the meeting to questions from stakeholders who wanted to know about the costs and fee structure; in-matrix testing; particulars of the accreditation process; and other concerns.
    • Jay Burns, Treeline Analytics Laboratory Director, asked through chat about the $400,000 “per year for IT [information technology] support and travel…wondering if there's a detailed budget…available” (audio - 2m).
      • Zboralski indicated that sum was “not an accurate number there for how much is the IT support and travel,” but those details would be available as part of the upcoming CR-102. Environmental Assessment Program (EAP) Program Manager Annette Hoffmann told the group that “the [$]497” included staffing for a DOE cannabis unit plus “there's travel; there's goods and services; there are the IT costs; and there's other admin support that is necessary for the unit to run.” Zboralski anticipated budget details would be released as part of an “evaluation process that…we're going to undertake in September and October.”
    • Expecting "it's gonna be a little crazy for the next year,” Burns asked about the different drafts of rule revisions, specifically when “a new version's put up that there's like version two, or a date or something.” He’d noticed a change between the two drafts had been “the fee structure where you sort of hid the amount from us” and inquired as to whether there were other significant changes (audio - 2m).
      • Zboralski said there had been “another line in there…that we felt was inappropriate regarding involvement with LCB.” Regarding the fee structure, “initially it didn't have that phase in…we hadn't been able to figure out if we had the ability to do a phase in as a mitigation attempt and that was the main” difference.
      • A revised proposed section WAC 173-55-060 removed a reference in the first version to a lab being allowed to “operate and conduct business, unless otherwise specified by the WSLCB.”
    • Burns shared that “I don't really understand why we can't just be lumped in with the environmental labs and use the infrastructure because I feel like that's, was the whole point of having you guys do this.” He asked in relation to “a typical environmental lab accreditation: how many hours would you say an employee puts in from the time of application until accreditation is granted?” (audio - 3m)
      • “It really depends on the size and scale of the laboratories,” Zboralski argued, “a small wastewater treatment plant that only has maybe a handful of wet chem parameters like pH, total dissolved solid, stuff like that it's maybe a day or two of desk audit and then…some ancillary work, but it also comes down to how interactive that laboratory is so it's really hard to kind of nail down a hard number.” He suggested larger commercial labs might have “500 parameters and that could take a month plus of, of work” and there was too much “variability” to give a fixed time estimate. Burns stated that this sounded like the answer was “somewhere around two to three weeks.”
      • He then asked if “this is going to be a full-time job for a chemist and a microbiologist with only eight labs” - adding his expectation there were “likely to be many less once this fee has to be paid.” Zboralski affirmed that was the intention, as “there isn't going to be the ability to find one person that covers both of them…based on the information we have now.” Aside from accreditation, he mentioned that staff would conduct yearly audits, “as well as all the work that is going to go on in the transitionary period that is difficult to quantify.”
    • “So basically…no infrastructure of the current [laboratory accreditation unit] will be used for cannabis,” Burns confirmed (audio - 1m).
      • Zboralski affirmed that they would be separate DOE units as it “would be too difficult from a…regulator aspect to be accrediting to two different standards for one…or two staff members.”
    • Next, Burns raised the issue of in-matrix proficiency testing (PT), recalling when he’d been a participant on the Cannabis Science Task Force (CSTF) and noting, “in this document it basically talks about how the proficiency test for potency, pesticides, and solvents needs to be in a cannabis material.” He remarked, “that's a heavy lift. It's probably not going to happen anytime soon,” but nonetheless in “task force recommendations…it was stated that it was a must.” Burns wanted to understand how that would be implemented and whether CLASP members were going to address that in rule changes for lab standards (audio - 6m).
      • Zboralski couldn’t speak for any department besides DOE, but felt “regarding the in-matrix PT's that is something that…could easily fall under that qualified accreditation…transitionary status…we've developed with the hope of being able to find a solution to that in the near future.”
      • Hoffmann described task force member realization that "there was a complicated choreography" of several state agencies, but WSDA was working on rulemaking and she believed “the agencies are very committed to making this work.”
      • Burns argued that unless a Washington agency was making cannabis PTs “it's not gonna be profitable for anybody…to buy a license and have a grow” in order to “sell to eight, maybe six, maybe four labs, in which case we're paying $200,000 a year for certification.” He thought this meant “qualified accreditation is still a full accreditation in as far as we can operate and do all the functions, right?” Hoffmann agreed the status was in place to reflect that there was “an evolution that still needs to happen,” one of the "situations beyond Ecology's control" but wouldn’t "create an all-stop in this area." Qualified accreditation meant if staff encountered a “situation like no in-matrix PTs for potency,” there could be a waiver “for that particular piece recognizing the change in data quality assurance comes with it.”
    • Cannabis Observer Founder Gregory Foster asked in chat when “will private labs have to complete their first Ecology audit to maintain accreditation in WA state without lapse?” (audio - 4m)
      • Zboralski responded that “upon July 1st of 2024 laboratories will have…this registration status that we talked about which is basically the laboratory is beginning the process of applying for accreditation, but…they haven't gained that accreditation.” Lab personnel could continue working as usual as far as DOE staff were concerned, he said, “and as far as we're aware there shouldn't be any impact to business.” Zboralski didn’t expect to see any lapses in accreditation, but he acknowledged “that could take a couple weeks, it could take a couple months,” depending on “individual case studies of each laboratory.”
    • A lab representative asked through chat about the role of WSLCB in the impending accreditation schema (audio - 2m).
      • Zboralski demurred, remarking that he wasn’t sure. Besides participating in CLASP, WSLCB involvement would be “up to them.” Hoffmann mentioned that as a regulator they could “set product standards” as well as deciding “what type of accreditation they want to recognize.” Alan Rue, EAP Business Operations Section Manager, conveyed that WSLCB staff would be in charge of “receiving data from the labs, from your testing data” for cannabis products.
    • Foster cited the preliminary language that “after an accredited laboratory submits two satisfactory PT sample results” in a year, they would be “required to submit only one satisfactory PT sample result in subsequent accreditation years. Are ‘satisfactory’ and ‘unsatisfactory’ defined for this context, or can those terms be clarified?” (audio - 2m)
      • Zboralski replied that the best definition for this was “basically pass and fail,” but the terms hadn’t been defined in rules. “That's a very good idea of something we can clarify in the definition section,” he commented.
    • Burns inquired whether the economic impact analysis would weigh the “impact of these rules and…consider lab attrition.” He speculated that if there ended up being only one accredited lab “they're gonna have to pay $500,000.” He then wondered “if you would also take into consideration…the economic impact of the rules being proposed by WSDA, or would that…be these two individual impact statements that don't consider…the sum of all the economic impacts that the labs are going to have,” something he felt would “have an impact on the producer/processors because testing is probably going to increase.” He condensed this down to asking “how expensive will the economic impact statement be” (audio - 2m).
      • Zboralski answered that the economic impact analysis would only cover DOE rulemaking changes, and that WSDA might have a separate process to review financial implications. He argued “our draft rule compared to what currently exists” would be used to solicit a DOE economist’s “best educated guess” of the “change before and after.”
    • Foster’s impression was that there was a “baseline annual cost” of $62,000, but he was uncertain if there was “additional cost for accreditation for parameter[s]” (audio - 1m).
      • “The short answer is no it's just going to be a flat fee” covering all parameter costs, said Zboralski, finding that wording differences between statutes for cannabis and other environmental labs impacted fee structures. Furthermore, “the environmental industry has been around for many decades at this point,” he observed, “there's a lot more, just history and adaptation that occurs over that time.”
    • In chat, DOH Microbiologist Tholo “TJ” Johnson chimed in to share “Regarding PTs: this is the CLASP draft rule that is currently being worked on...If the PT provider does not provide individual acceptance criteria for each analyte, the following criteria will be applied to determine whether the lab achieves a passing score for the round of PT (audio - 3m):
      • (a) +/- 30% recovery from the reference value for residual solvent testing; or
      • (b) +/- 3 z or 3 standard deviations from the reference value for all other fields of testing.”
      • Zboralski thanked Johnson for providing specifics. “I think that's something that possibly we could look to incorporate in” definition rules, he added.
    • Burns raised the question of “what the burden of proof for denying accreditation” was (audio - 7m).
      • Zboralski replied that should lab staff fail to do an available PT “that's usually a pretty solid burden of proof that to deny accreditation if the laboratory is unable to prove through the audit process that they can accurately recreate their data…to clients on, in a cradle to grave manner…that could be grounds for denial depending on the severity of what's missing.” He indicated there were many kinds of problems which “most often [came] up in the environmental world when laboratories either don't run a PT when there's ones available, or” the PTs that were run “all failed.”
      • Rue continued, stating that lab officials would need to prove they’re “meeting the accreditation standards, which [were] standards that we have in our rule, WAC 173-55.” Standards to be set in WSDA rule would be what DOE used to perform the accreditation process, he explained, which also “involves technical assistance” and working with businesses to “make sure that we're helping you to come into compliance with the standards.”
      • Zboralski remarked that fraudulent or unethical practices would also be grounds to deny accreditation, but for labs it generally “revolved around PT… issues and/or documentation gaps.” He differentiated between accreditation denial and a suspension or revocation: “denial is something that is a little bit more benign and…you've got some problems, but we can work to fix this,” whereas a “suspension/revocation is like a little bit more severe…that level of severity of what caused the…denial or the suspension is kind of where that line falls.” Failing to meet criteria, or work to remedy such failure, meant labs “don't get to…get or keep their accreditation. And usually…mal intent is…a good defining line between denial and suspension/revocation.”
    • Johnson asked about adding wording in the definitions on “deficiency in the application steps necessary to upgrade the laboratory to accredited status.” Zboralski said he’d need to read the “section in whole” directly to be sure, but would get back to Johnson about that (audio - 2m).
    • In chat, someone referred to section 3 of the draft rules: ‘“if the department grants accreditation in part..." What is accreditation in part? Currently there are required fields of testing, will that go away? For example, can a lab test only pesticides or residual solvents?’ (audio - 3m)
      • DOE staff would accredit by parameter, stated Zboralski, and “in part” occurred when a lab “applied for seven parameters…and you're able to gain accreditation in five of them.” As for what was required, he couldn’t speak for WSLCB or other agencies, but DOE staff “grant accreditation to each individual parameter in order to…show that laboratories are proficient in everything that can fall under that category and is required in WAC.” Zboralski felt there remained “a little bit of confusion there" which regulators were working to sort out.
      • Johnson followed up to outline how lab leadership could seek accreditation for specific fields and then contract with other accredited laboratories to test products “for the other fields.” However, Zboralski made clear that arrangement “will fall a little bit outside of” DOE staff’s consideration, as they would worry about accreditation, not contracting (audio - 4m).
    • The final question regarded the word “parameter” and whether DOE would count it as the “compound or an entire test” (audio - 1m).
      • Zboralski answered the term parameter referred to a particular compound “by the approved method in the appropriate matrix.”
  • Mugdha Flores, Environmental Assessment Program (EAP) Communications Manager, addressed the timeline for the rulemaking project as the workshop came to a close (audio - 1m).
    • Beside mentioning a public comment portal and Zboralski’s email for anyone with further feedback, Flores pointed out that the DOE webpage for the rulemaking project included a rough timeline:
      • “Fall 2023 - Proposed rule (filed the CR-102 form). Started public comment period with rule text and supporting documents
      • Winter 2023 - Hold public hearings.”
    • Zboralski thanked attendees for their participation as “the process works best when we get the most engagement from you guys,” and promised to “incorporate as much as we possibly can” of the input given (audio - 1m).

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