DOE - Webinar - Accreditation of Cannabis Laboratories - Public Workshop
(August 2, 2023) - Summary

2023-08-02 - DOE - Webinar - Accreditation of Cannabis Laboratories - Public Workshop - Summary - Takeaways
[ Event Details ]

With DOE staff moving forward on cannabis lab accreditation rulemaking, they explained the expected timeline for draft rules and heard feedback about the costly implications for labs.

Here are some observations from the Wednesday August 2nd Washington State Department of Ecology (DOE) webinar workshop on the Accreditation of Cannabis Laboratories rulemaking project.

My top 4 takeaways:

  • DOE Chemist Ryan Zboralski spoke to the history and process behind the rulemaking project, including a potential timeline for approval by the department.
    • Zboralski looked at “how we got here post-task force,” pointing out both of the CSTF reports, Laboratory Quality Standards for Pesticides in Cannabis Plants and Products and Cannabis Laboratory Quality Standards and Proficiency Testing (PT). He stated the efforts of staff were on how to “appropriately implement the recommendations from the task force, and create a robust cannabis accreditation program while being in alignment with our sister agencies.” Zboralski provided “five specific needs” DOE officials had (audio - 2m):
      • “We need a multi-agency collaboration with LCB, Department of Health,” and WSDA to “coordinate and align the different pieces that go into both our roles, and theirs.”
      • “We're looking to develop a proficiency testing program with the collaboration of the other agencies.”
      • “WSDA [was] working to adopt lab quality standards.”
      • “Withdrawal of the current accreditation standards at LCB, or amendment of them as necessary.”
      • “Adoption of the new accreditation standards and associated fee schedule that we're working on.”
    • Zboralski suggested there were “many small steps that will eventually start to add up to getting the improved consumer protections.” There would also be “major steps” which he identified as “adopting the lab quality standards in rule,” getting CLASP “up and running, and then coordinating the rulemaking processes between all the agencies” for the “series of new, revised, and withdrawn rule actions that are part of that.” Additionally, “with our deadline of July 1st of next year quickly approaching, we're starting to set those pieces in motion that are within our control to be ready,” he concluded.
    • While reviewing the rulemaking process at DOE after lab accreditation had been filed as a CR-101, Zboralski described the webinar as part of “meeting with our external stakeholders.” He also offered a potential timeline to adopt revised rules by the July 1st, 2024 deadline (audio - 4m).
      • “After receiving…feedback from stakeholders” and making changes to their draft rules, “a formal internal review can begin which includes a rigorous eight-week economic review process that evaluates and documents the economic impact of the changes in preparation for the formal proposal of the rules with the CR-102.”
      • Once a CR-102 was filed, “we enter the formal public comment period. This is a critical part of the rulemaking process that will allow the general public the opportunity to provide their feedback” as officials “prepare our preliminary rules for the economic and other reviews done through September and October.”
      • “We are planning to propose our rules on October 31st…and begin our formal comment period” in the “later part of this November and December, and having a close before the holidays so that we have ample time to incorporate” responses.
      • “We enter the final internal review processes in…mid-to-late January, or early February,” and rule adoption was expected by “March 21st of 2024.” “Typically when…rules are adopted they go into effect 31 days after adoption, however” because there was a statute that specified the “July 1st, 2024 date we are delaying the effective date until then.”
  • Zboralski next detailed the draft rules, including definitions; the process and types of laboratory accreditation; as well as additional actions and a new fee structure (audio - 13m).
    • Bringing up the guideposts for their rulemaking, Zboralski named the 2019 law requiring the transfer of accreditation authority to DOE and existing statute on required cannabis testing as the “primary legal references for what the rule needs to accomplish.” He further named existing environmental rules which “made sense to incorporate into our cannabis rules” given DOE “experience with the environmental and drinking water labs.” Zboralski felt such inclusion “was both in line with the desire of the legislature and the best way to ensure that we have a robust and viable program.”
    • The “relevant Cannabis Science Task Force recommendations” were also a consideration, though Zboralski reported “many of the recommendations were not practical to place in our accreditation rules since there were more targeting the lab quality rules being handled with LCB and/or WSDA.” He said authorities had worked to avoid “direct conflict” with the recommendations, and that the draft put rules in “lock step” with CSTF proficiency testing recommendations.
    • Zboralski started going through the sections of the draft rules, proposed as chapter 55 of Title 173 WAC:
      • “The first three sections are standard…purpose section clearly outlining the purpose of the WAC…clearly outlining the applicable scope that” the WAC covers, and additional definitions “that clarifie[d] any industry jargon, or other terms used.” Definitional changes were “slim” so far, and feedback was encouraged. But new definitions for “parameter” were drafted pertaining to “each individual parameter, which is a specific analyte, by specific method, in a specific matrix.” With cannabis, “that would mean that pesticides accreditation would be for each individual pesticide the laboratory is required…by their developed method in the cannabis flower matrix.”
      • Eight sections pertained to the “accreditation process,” including “accreditation approval requirements…a pretty high level recap of the minimum items that laboratories are expected to provide or participate in to gain accreditation.” There were also sections on “application for accreditation or registration,” registration status covering a “transitionary period between WSLCB accreditation and Ecology,” as well as a “quality assurance manual section” that was “brief” in order to let “labs have the appropriate flexibility to build a…quality assurance manual that is appropriate and fit to their needs.” Other accreditation sections involved “data and record traceability” with “minimal expectations and requirements…that the unit is expecting to see at laboratories,” plus a “proficiency testing section which outlines…accreditation’s minimum requirements for PTs.” 
      • “Subsection 3 [was] different than the environmental rule and is in recognition of the recommendation from the task force that PTs for potency, pesticides, and residual solvents must be available in-matrix to grant full accreditation.” Other CSTF recommendations were most “appropriate to be clearly discussed in guidance documents once the unit…is in place and those documents are being drafted, which we hope to be happening immediately after the rule is complete.”
      • “The audit section is next” and went into “pretty good detail regarding the process and items of primary focus on, on audits whether that's being done on-site, or virtually. It also discusses the frequency of audits, which” would continue to be annual. One section involved “evaluation of the certificate” describing the “immediate steps ecology and the applicant laboratory undertake after going through the accreditation process.”
      • There would be several accreditation types which could “be granted to a laboratory's parameters,” coming primarily from “method descriptions and categories from the existing WSLCB WAC and the…Cannabis Science Task Force recommendations.”
        • “Qualified accreditation...where the regulatory agencies other than Ecology can formally request to waive a specific requirement of Ecology,” which would permit “flexibility needed for an evolving industry like cannabis, and we anticipate that this is a type of accreditation” would “assist in the transition period between WSLCB to us at Ecology over the near future.”
        • “Interim accreditation” for any lab covered “parameters that have been granted accreditation prior to conducting of an audit, but after all other supporting documents…have been reviewed and are acceptable.”
        • “Provisional accreditation” was “a status that occurs when a laboratory can consistently produce valid analytical data, but have deficiencies requiring corrective action” such as “a recent history of PT inconsistency.”
      • Following lab accreditation, there were sections dealing with “situations where accreditation is not granted…typically this accreditation status can be easily rectified through certain steps that the unit outlines…without needing to go through more formal suspension or revocation process. Usually this status is granted during an initial accreditation or renewal process, and the laboratory and the department work collaboratively for the laboratory to gain accreditation.” Additionally, there was a section on “revoking or suspending accreditation” which could direct specific actions needed by labs to have their accreditation restored, or could result in total revocation. There was also a section on the appeals process for suspensions or revocations, as well as “a short brief section regarding…compliance inspections and access,” along with one covering “how and when informal assistance to laboratories can be provided.”
    • Zboralski told the group the fee structures in RCW 69.50.348 "required the most deviation" as the enabling statute says DOE could only recover fees from labs. DOE staff “projected our expected cost for doing that work, and divided that number by…the number of currently accredited laboratories.”
      • He anticipated the cost was “going to be significant,” but the fee structure would be adjusted annually, and there would be a “four-year ramp up…to hopefully lessen the suddenness of the economic change." 
      • Zboralski added that in order to “ensure mid-year work is done in a timely manner, we have also created a down payment subsection to cover this work. Think of it as I want to add something to my scope mid-year…we have developed” a process where Ecology personnel may “cover that work and we take that out of your fees at the end.” This was done because “ongoing or extended mid-year work that doesn't get recouped [was] a current issue with the environmental WAC…and we wanted to avoid that loophole.”
  • Following comments by staff, several attendees asked about proposed fee schedules, inspections, and audits before the event was brought to a close.
    • Zboralski invited comments or questions about the draft rules, promising that staff would “offer as much clarification as we can” (audio - 1m). Flores noted additional links and resources had been shared in the chat log (audio - 3m).
    • Via chat, someone asked for more information about the proposed fee schedule. Zboralski replied that beginning July 1st, 2024, the yearly fee would be set based on an equation, and that “for the first year it's going to be roughly $62,000” per laboratory. He remarked, “that fee will be reduced by 75% rounded to the nearest whole dollar” in fiscal year (FY) 2024, “whatever the calculated result is it'll be reduced by 50% rounded to the nearest whole dollar” in FY 2025, and then “reduced by 25% rounded to the nearest whole dollar” by FY 2026. They were interpreting statutes as requiring the department to “fully recover…our cost of our program through the fees,” said Zboralski (audio - 2m).
    • The same commenter followed up, curious what “type of timelines do we have to prepare for an on-site visit?” Zboralski hypothesized that lab personnel might have a “month and a half,” but that it could depend on “lab size and scope of the laboratory” along with the records they were able to see from a lab before arriving to audit. “We understand that audits…can be a real difficult situation for laboratories to conduct business, so we want to try and minimize risk” or the “effect to their operations,” he explained  (audio - 1m).
    • Jeff Doughty, Capital Analysis CEO and Chemistry Manager, thanked the hosts and promised to submit comments electronically (audio - 1m).
    • The next chat question about required preparation for audits led Zboralski to state that audits could include standard operating procedures for methods, proficiency testing results from the preceding year, “initial demonstrations of capability” documentation, and any “validation paperwork; the lead up to the audit is mostly covering the paperwork that is required” (audio - 2m).
    • Medicine Creek Analytics Science Director Amber Wise sought clarification that accreditation fees would start at $62,000 per lab, skeptical that her business could meet that threshold on top of other method or process costs. Zboralski reiterated that the staffing and oversight costs for the eight current accredited labs would start at $62,000 each, but “for year one that'll be reduced by 75%,” totalling $15,500 in FY 2024, and if the number of participating labs stay the same” by FY 2025 it would be $31,000, and then $46,500 by July 2026, “with the $62,000 being in place July 1st of 2027” (audio - 4m).
    • In chat, someone wanted to know if audits would come only from DOE staff, or whether there would be third party audits. Zboralski affirmed only the department “staff [consisting] of a microbiologist and a chemist” would be performing them (audio - 1m).
    • Cannabis Observer Founder Gregory Foster wondered “how the proposed annual fee compare[d] to other comparable sectors that you accredit, and if there are other means [of] revenue which are leveraged in other sectors?" (audio - 2m).
      • Fees were typically spread out over “a lot larger of a customer base,” leaving it “hard to compare the difference between charging it to 450 [environmental] labs, to between eight laboratories,” Zboralski argued. Furthermore, cannabis testing faced “federal legal confines” environmental labs did not, and Zboralski believed this limited market involvement. He wasn’t aware of other revenue sources to cover the fees, stating the language in the statute had been “pretty clear that we can really only collect our fees from, from the cannabis laboratories within the state.”
    • Flores highlighted the DOE webpage for the rulemaking project, as well as the public comment portal and Zboralski’s email. She then mentioned a second webinar on the matter scheduled for Thursday August 10th (audio - 3m).

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