WSDA - Webinar - Cannabis Laboratory Standard Feedback
(June 28, 2023) - Summary

After a background on the draft rulemaking and method list for cannabis laboratory standards, stakeholders raised a lot of concerns and questions around expense and implementation.

Here are some observations from the Wednesday June 28th Washington State Department of Agriculture (WSDA) Webinar for Cannabis Laboratory Standard Feedback.

My top 3 takeaways:

• Staff briefed on the rulemaking, which represented WSDA staff effort to codify cannabis testing laboratory standards (audio - 7m, Rulemaking Project).
  • A 2022 law which required the change emerged in part based on the Cannabis Science Task Force (CSTF) Steering Committee which produced a 2021 report that offered “guidance for rulemaking before the accreditation authority [for labs was] transferred” from the Washington State Liquor and Cannabis Board (WSLCB) to the Washington State Department of Ecology (DOE). The same law established the WSDA-led Cannabis Lab Accreditation Standards Program (CLASP), which included representatives of WSLCB and the Washington State Department of Health (DOH).
    • After task force members debated the timeline for lab changes with DOE leaders at the CSTF meeting in June 2021, DOE staff told lawmakers about the report that November. The group’s last meeting was in January 2022.
  • On January 10th, WSDA staff released a CR-101, followed by draft conceptual rules on cannabis testing lab quality standards on June 22nd. A day earlier on June 21st, DOE staff published a complementary rulemaking effort on “Accreditation of Cannabis Laboratories.”
  • Beginning the webinar, Cannabis Programs Manager Trecia Ehrlich voiced gratitude for all attendees, as “being present here is helping us and the State work to create safer laboratories, safer cannabis, a new standard.” She further recognized how WSDA had required “an incredibly tight turn for you to receive a very large and detailed document” and provide feedback, articulating an intention “to say ‘we are coming here with a sense of urgency, we want to do this quickly and we want to start the process of engaging you now.’ This is in no way a final draft, it is in no way your final opportunity to provide us with feedback.”
    • At a May 18th meeting of the Washington State Hemp in Food Task Force, Ehrlich indicated that CLASP members were expected to become involved with determining tetrahydrocannabinol (THC) detectability, but only after fulfilling a prior legislative mandate to “accredit these labs by June of 2024” which remained on “a pretty tight timeline to deliver that original product.”
  • Nonetheless, Ehrlich noted the “timeline as provided to us by the legislation is to have an accreditation prepared by June of 2024. And that is something that the Department of Ecology is supposed to do,” but “they need our standard in order to create their accreditation standard.” Ehrlich stressed the webinar was the first of several chances for the public to weigh in on rulemaking at WSDA, and further noted the draft wording was “not quite in a rule format yet, it's really more of a draft standard.” She explained that Rules staff at the department would be “massaging” the text to a “classic” rule format and specific wording was still being changed, “but the heart of the content is what the original ideal was for a standard” to be added in WAC Chapter 16.
  • Ehrlich conveyed the hope of staff to hear “how the standard that we've written thus far, would economically impact you,” adding that “our feedback of course has the power to change the standard.” She speculated this could include “probable costs” such as “equipment supplies; labor; professional services and increased administrative costs; and whether compliance with the proposed rule will cause business to lose sales or revenue,” as well as the “number of jobs that will be created, or lost, as a result of compliance with the rule.” Other feedback could be emailed to their staff, Ehrlich stated, and Lead Chemist Dave Michaelsen, also the CLASP coordinator, was present to respond to questions from laboratories along with CLASP Chemist Nick Poolman.

• Department staff took questions from private laboratory representatives on both specific and broader concerns regarding how the envisioned standard would impact their businesses, with some relating it to continued adjustment to pesticide testing rules adopted in 2022.
  • Jamie Deyman, True Northwest, Inc. President, expressed concern that “on the micro end, we may have difficulty, money wise, changing over to testing” a process called Polymerase Chain Reaction (PCR). This might cost their company “$300[,000] and up,” she said, while “we are struggling…with payments on our instrument to do pesticides, plus our validation for pesticides.” If rules required PCR on top of those obligations, she projected the capital investment was "going to be pretty much impossible for us" (audio - 2m).
    • Explaining he was not a microbiology expert, Michaelsen believed there were "multiple ways to look at this.” While PCR was "one of the best" techniques for that testing, the group would see if other options “meet the guidelines” and follow up on the concern.
  • Paul Manzares, True Northwest Laboratory Director, asked in chat "What level of microbiological detections are you looking into? If going toward [federal Bacteriological Analytical Manual]-like protocols then what level of dedications towards molecular or ELISA confirmations etc.? All of this adds extra cost and it is not easy to guestimate cost without knowing more details" (audio - 1m).
    • Commenting that Microbiologist Lauren Christiansen was “stuck in a storm,” Ehrlich promised to get back to them on the topic. WSDA staff subsequently shared an email from Christiansen responding to questions raised during the webinar.
  • Amber Wise, Medicine Creek Analytics Science Director, expected "easily $100[,000] of investment” costs for their business, and potentially “a full bachelor degree chemist to run…relatively basic tests like foreign matter or water activity, plus re-accreditation costs which are upwards of seven to eight [thousand dollars], because we'll have to completely revalidate probably almost all of our methods.” She thought there would be other expenses relating to “a four to five times increase of cost in terms of solvents, and waste…because we don't use this much for all of these tests.” Wise argued that since changes related to pesticide testing had taken away “more than half of our volume,” new requirements would be “really hard” for the business (audio - 4m).
    • Michaelsen responded that existing testing rules aimed for a sample size with enough “going to the laboratory so they can complete all their testing without dropping the size of the sample so small that it affects the sensitivity of that test, or even the reliability of what that test can identify.” He continued, saying sample sizes should be set with the needs of laboratory staff in mind: “it was a starting point so that we could discuss with the laboratories what they felt, and what their validation studies have really shown them for that sample size.” Adequate sample sizes to do testing “repeats” if needed was another consideration, Michaelsen added before suggesting WSDA personnel intended to “send out a survey” for labs on that point in the future.
    • Nick Mosely, Confidence Analytics CEO, shared in chat, "I tend to think these are very appropriate sample sizes. Sorry to contradict, but 0.5 grams is a very appropriate minimum. I appreciate it going down to 0.25 for residuals. And to confirm 1 cfu/g you necessarily need at least 1 gram. [For what it’s worth,] these are the same sample sizes as in [testing rules for] California."
    • Wise noted keeping samples refrigerated was “another huge cost for us that I don't think is going to actually lead to better or more safer products.” In chat, Mosely agreed that “nothing in industry is stored at that temp."
  • Jeff Doughty, Capital Analysis CEO, remarked in chat “automated liquid handlers are quite expensive (looking at the homogenization section)," speculating they could cost $100,000, though he hadn’t looked at their cost “in quite a while” (audio - 1m).
    • Doughty, Wise, and Mosely previously served on the CSTF Steering Committee.
  • Deyman highlighted “mentions that you would prefer different lot standards,” which could add expense through complexity, however she did feel labs had solved that in the “environmental field by having somebody else besides you make the same working standard” (audio - 2m).
    • Michaelsen replied that regulators had encountered similar problems with standard lots purchased through different suppliers: “it turned out they got them both from the same supplier, and it wasn't able to correct the issues that we had on a concentration.” He brought up that the goal was for “whatever your calibrators are made up of, stock standard are not the same as your controls, because that makes it a real challenge to verify that you have a valid curve to get…an accurate concentration, but…we will have to come up with solution for that” if there turned out to be a single supplier.
    • Mosely posted his preference that, in sample validation, the continuing calibration verification (CCV) “be of same source, but ICVs [initial calibration verification] be of different source" (audio - 1m).
  • Turning to “document control,” Deyman said the draft led her to think “we've got to hang on to things for five years and…I read that it was three years…is what we're supposed to be doing right now” (audio - 3m).
    • Michaelsen affirmed rule changes wouldn’t be retroactive, but officials wanted the ability to look at older samples “because there have been some products that have been pushed out there that weren't identical to the testing when they should have” been. He remarked that in the “clinical world,” data might be preserved for “seven, ten, and 25 years, depending on the type of tests performed.” While this length was deemed longer than necessary, Michaelsen mentioned five years of preserving digital copies of test results in the event litigation or regulators called into question a product’s results subsequent to its sale.
  • Manzares next inquired in chat about “lot size relative to the ‘minimum sample size’?” (audio - 2m)
    • Poolman was a “bit confused on the question,” but believed that the “minimum lot size…ten pounds for flower…there's enough sample with all the minimums here to complete it.” Michaelson affirmed that the intent of the rules was to be sure labs were given enough cannabis to complete any testing.
  • Staff from Integrity Labs posed a question in the chat: “Will the LCB be re-writing the WACs to match the requirements in this document, as many of the rules in this contradict the WACs" (audio - 2m).
    • Ehrlich anticipated WSLCB would “rescind” any conflicting rules, but that their review process was ongoing. Justin Nordhorn, WSLCB Director of Policy and External Affairs, said the scope of changes would be determined based on the “types of standards that are being drafted.” Details about what would remain from the product quality standards already in rule were still “in the air.”
  • As a member of the CSTF Steering Committee, Mosely felt they’d been “repeatedly reminded" about differences between lab and product standards, yet, “some of the draft appeared more as product,” rather than lab standards. He wondered whether product standards would remain the purview of WSLCB, while WSDA rules had “perscription or performance criteria” for labs. “Basically…the [WAC] 314-55-103 is the section that I thought the WSDA was taking on,” rather than WAC 314-55-102, “which I see some of in here,” Mosely said. He was curious if the appearance in “two different areas of code” would lead to it being “more difficult” to change product standards in the future (audio - 5m).
    • Ehrlich felt the “interesting question” raised by Mosely illustrated “there can be some challenges and technicalities related to when one side edits the rule,” but WSDA leaders would revisit rules if WSLCB adopted “any” changes.
  • Who was responsible for collecting samples had “repeatedly come up” in the CSTF as a “product standard concern, and not a laboratory methodology concern,” but Mosely took issue with that interpretation, asking directly “who collects the sample and when?” (audio - 2m)
    • Ehrlich’s understanding was the top challenge had been “it does not appear we have regulatory authority over sample collection,” so department staff only planned to address sample collection in the event WSLCB removed it from their rules. 
    • Manzares agreed that State officials had always had a hand in sample collection of other agricultural commodities, and called it “very odd” they didn’t have a greater role in sampling a “consumable product.” He additionally felt the sample sizes offered were acceptable for “analytics,” but could be a bit small since it was “representative sampling, and it's based solely upon the client” (audio - 1m).
  • Deyman brought up foreign matter inspection, specifically about the required photographic documentation (audio - 2m).
    • Michaelson answered that regulators had been thinking about “a stereoscope,” but the standards for the need to identify and document samples wouldn’t change.
  • Doughty and Wise were curious about the prescribed methods list, and the draft mention of a “written approval” system for substituting methods (audio - 1m).
    • Ehrlich explained such methods could be “clunky” to put in rules, but that there would be a reference manual produced and referenced by WSDA that would be published as part of the rulemaking process.
  • When Wise inquired about the deadline for giving feedback, Ehrlich explained the “easiest time” was within the upcoming week, but there would be additional opportunities for providing comments after WSDA staff published draft rules in a CR-102 (audio - 1m).
  • Mosely speculated that the manual would feature a “prescriptive” method for measuring potency, referencing lab regulations used in the State of New York (audio - 4m).
    • Poolman showed a list of some methods being considered, and stated they included those which had been recommended by the CSTF in 2021, while methods approved in New York were newer. Mosely argued laboratory leaders wouldn’t like the methods from New York and would be able to offer alternatives. Poolman stressed that the rules were still being developed and no one was being told to change validation approaches at that time. However, with regard to the validation methods endorsed by CSTF, he would “not say we're a hundred percent on that yet.”
    • Ehrlich brought up the written approval for a substitute method mentioned on page 38 of their draft language: “The WSDA may waive proficiency tests for certain parameters if approved PT samples are not readily available or for other valid reasons.
      • (a) If a proficiency test is not available for any analyte, the laboratory must implement an alternative assessment procedure for the affected analyte(s).
      • (b) An alternative assessment requirement can be fulfilled via a split-sample analysis sent to testing staff as a blind or potential customer sample unknown to the analyst.”
      • She said they didn’t want labs to have to invest in new methods before “a rule is finalized,” and then confirmed to Wise that there would be additional clarification of the written approval process (audio - <1m).
  • Wise wrote “Will labs be required to comply by June 2024 or there will be a year after that to [come into] compliance?" (audio - 2m)
    • “We’re having conversations right now with the Department of Ecology and the Liquor and Cannabis Board to understand what that time will look like,” Ehrlich answered.
    • WSLCB Chemist and Cannabinoid Science Work Group member Angela Peck chimed in to say that a “transition” period was being planned and would be “realistic for all the labs to come into compliance” ahead of the “official transfer” of accreditation to DOE.
  • Deyman wondered whether their accreditation schedule and procedures would stay the same (audio - 2m).
    • When Poolman answered that would be up to DOE officials, Deyman added that she’d heard the department was “very short-handed and it has been a really long time since [her sister’s environmental lab] had any kind of a physical audit, or even a paper audit.”
  • Wise then wanted to know when the “timeline for who (which agency) is in charge and when we'll be required to be in compliance?  This unknown situation is pretty difficult to make any sort of business or scientific plan for the coming months" (audio - 1m).
    • “We have been in pretty frequent conversations with the Department of Ecology and given the timeline,” Ehrlich wanted to “figure out a little bit more of what this looks like in the next…before August 1st.” She expected regulators and stakeholders would find it “challenging…if we don't have a strong understanding of what this whole transition process will look like.” Ehrlich believed agency leaders would know more “in the next month.”
  • Michaelsen said the CSTF recommendation had been implemented through the draft, although some of the standards were still “up for discussion.” He added, “we are writing these rules for the laboratories not to torture them,” nor to “put you out of business or anything else” (audio - 3m).
    • He stated WSDA leaders intended to have “three standard testing methodologies for the three recommended tests, and the other ones, obviously based off of performance.”
    • Officials wanted stakeholders to continue to “nitpick at some of this,” and Michaelson explained that they would also look at standards in other states. He encouraged more review and feedback from attendees, “so that we can look at things from your approach, and see how…they will affect the overall quality of the testing over time.”
  • Poolman commented on representative matrices for method validation, suggesting staff wanted input on how many matrices there should be, but no participants shared advice on the topic (audio - 1m).
    • DOE representatives may be hesitant on accepting representative matrices.
    • The draft rule wording would instead allow WSDA to “waive proficiency tests for certain parameters if approved PT samples are not readily available or for other valid reasons.”

• Bringing the conversation to a close, WSDA staff talked about what steps lay ahead in the rulemaking project.
  • Michaelsen described how they would consider the comments and subject areas raised, and follow up with stakeholders if their written comments were submitted by the “end of next week” on July 7th (audio - 1m).
  • Ehrlich quickly surveyed attendees as to whether they’d want an additional meeting, or to submit further comments via email. Several participants favored both, and Poolman forecast that edited prescribed methods could be sent out in a “couple weeks” (audio - 2m).
    • A prescribed methods list was distributed after the meeting.

Information Set