The Department solicited cannabis testing labs to perform analysis of hemp samples, a federal requirement expected within 15 days prior to harvest of every acre of hemp grown in the US.
Here are some observations from the Tuesday March 31st Washington State Department of Agriculture (WSDA) preproposal conference for cannabis testing laboratories interested in applying to contract with the Department for analysis of hemp.
My top 4 takeaways:
- A Request for Qualifications and Quotations (RFQQ) was issued by WSDA on Friday March 27th to solicit cannabis testing laboratories to contract for analytical testing of hemp.
- The WSDA Commodity Inspection Division’s Hemp Program “regulates the production of hemp grown within Washington State as required under chapter 15.140 RCW, chapter 16-306 WAC and the United States Department of Agriculture (USDA) interim rules” according to the full RFQQ. Washington state’s hemp program “has been formally accepted by the USDA and conforms to USDA’s requirements for sampling and testing of hemp.”
- Learn more about USDA’s Domestic Hemp Production Program, legalized via the 2018 Farm Bill, or WSDA’s hemp licensing for 2020 and current hemp program activities.
- Federal and state laws require hemp crops be tested for their post-decarboxylation Δ9-Tetrahydrocannabinol (THC) and Δ9-Tetrahydrocannabinolic Acid (THC-A) content, also known as the crop’s “total THC concentration level.” Hemp must test below 0.3% total THC or it is said to be marijuana.
- Under WSDA’s frequently asked questions for the meaning of total THC, the Department explains a “calculation is applied to find the delta-9 THC amount in the THCA: (delta-9 THC = delta-9 THC + (THCA * .877)) The equation states 87.7% of the measured THCA is delta-9 THC.”
- WSDA Contracts and Procurement Manager Ashley Blowers coordinated the preproposal conference webinar and call as she was “helping with this RFQQ process as well as finalizing the resulting contracts.” (audio - 4m)
- She said the conference was organized to review “details” and to “allow for questions” from prospective vendors to “understand what we’re asking and what our needs are.”
- Blowers explained that the RFQQ’s goal was to find “multiple qualified laboratories for testing of hemp in the state of Washington” and commented that contracting to test samples from “neighboring states may also be an option.” Labs needed to be able to show whether hemp samples were “THC compliant” to “help approve it for distribution.”
- She promised that questions or feedback would be collected and be made available both on the program’s website and WSDA’s hemp listserv. She asked that questions about the RFQQ be directed to her by email at ablowers@agr.wa.gov .
- On the call representing WSDA:
- Ashley Blowers, WSDA Contracts and Procurement Manager
- Jessica Allenton, Commodity and Inspection Division Assistant Director
- Rachel Furth, Commodity and Inspection Division Business Administration and Operations Manager
- Melissa Andrusak, Acting Hemp Program Coordinator
- Blowers said that Andrusak was an interim replacement for Steven Howe who’d left WSDA for “other opportunities.”
- Representatives of laboratory vendors:
- Jamie Deyman, True Northwest Laboratories President
- Dale Mann, ESi Consultant
- Kent Oostra, Exact Scientific Services, Inc. CEO
- Pat Reynolds, Confidence Analytics Operations Director
- Amber Wise, Medicine Creek Analytics Scientific Director
- Jason Zitzer, Trace Analytics COO
- Citizen observer Gregory Foster was also on the call. As visibility into the list of participants was restricted, there may have been others listening in. Cannabis Observer subsequently requested the list of participants and other records associated with the call.
- The WSDA Commodity Inspection Division’s Hemp Program “regulates the production of hemp grown within Washington State as required under chapter 15.140 RCW, chapter 16-306 WAC and the United States Department of Agriculture (USDA) interim rules” according to the full RFQQ. Washington state’s hemp program “has been formally accepted by the USDA and conforms to USDA’s requirements for sampling and testing of hemp.”
- WSDA’s Commodity Inspection Division and Hemp Program staff described the Department’s expectations for testing, reviewed the contents of the RFQQ, and projected a timeline.
- Allenton told the group that WSDA had received several questions about what they were “really looking for” from the testing labs (audio - 4m).
- She said that the Department was attempting to hire “the most labs possible between now and harvest” and engage in “lab-to-lab collaboration as we create a hemp lab network" across the state.
- Allenton noted that although “a majority of the contract” was focused on THC testing, WSDA was also interested in labs able to perform testing for "voluntary certification for human consumption" according to WAC 16-306-100. She asked that labs also “acknowledge” if they were capable of pesticide, heavy metals, and/or mycotoxin testing when applying for the RFQQ.
- Allenton added that the Department had received questions about labs needing to register with the U.S. Drug Enforcement Administration (DEA) and noted that registration with the federal agency was “not a requirement at this time” and had been postponed until October 31st, 2021 or until USDA’s “final rules go into place.”
- Furth said she played a smaller "administrative piece" in the program (audio - <1m) while Andrusak told those on the call that she’d be fielding the “hemp testing lab procedure questions.” (audio - <1m)
- Allenton went through the timeline for the RFQQ, saying “continuous reviews” of vendor applications would commence on April 10th and WSDA would begin approving qualified labs for testing as quickly as possible “to perform that service by harvest.” Blowers chimed in to say that the Department would likely review applications “every couple weeks” depending on how many were received and how often (audio - 3m).
- Allenton then proceeded through the RFQQ's requirements (audio - 5m).
- The minimum qualifications for WSDA’s program were "basically the exact same" as USDA’s requirements. Labs would be required to be licensed to perform testing in Washington and though they were not required to be ISO-17025 accredited, Allenton explained such accreditation was still “encouraged.”
- Labs would be expected to conform to WSDA’s “testing protocols.” WSDA aimed to contract with labs which could “turn around our samples within ten days and submit electronic [Certificate of Analysis (COA)]s” but acknowledged that extensions could be granted with adequate communication. Allenton reported that WSDA “reserved the right to do hemp sample testing” with any lab “that we move forward with” and vendors would be expected to meet “security,” privacy, and Americans with Disabilities Act (ADA) requirements.
- Contracts would run through October 31st, 2021---“two seasons”---as the Department anticipated USDA would issue final rules and “if any changes need to occur we can address them at that time.” Lastly, she said that all contracts would be “in place” by June 15th ahead of harvests “starting in July.”
- Staff delved into the scoring process on qualifications the Department used for ranking of applications in section 3.3 of the RFQQ.
- Allenton addressed some basics of what was scored (audio - 1m).
- Blowers noted that the scoring system was the Department’s attempt to make “that evaluation standard across the board” while allowing vendors to see “what matters to us, how much it matters to us,” and how prospective contracts would be evaluated (audio - 1m).
- Andrusak reiterated that WSDA wanted testing for “total THC content” using high-performance liquid chromatography (HPLC) under the same rules as the USDA. THC testing was required for any licensed hemp producer prior to harvest who wanted to “take it off their registered land area to sell it.” She went through some qualifications such as laboratory staffing, “turn around” time, and “measurement of uncertainty.” Andrusak remarked that labs wanting to be approved to perform human consumption testing would need to demonstrate pesticide testing proficiency (audio - 3m). She added on to her comments, saying that labs would also need to supply pricing information, “optional” Office of Minority and Women's Business Enterprises (OMWBE) information, and “three business references.” (audio - 3m)
- Allenton told the group that WSDA had received several questions about what they were “really looking for” from the testing labs (audio - 4m).
- Laboratory representatives had a whole host of questions about contract requirements, scoring of qualifications, and the RFQQ’s supplemental exhibits.
- Questions on the RFQQ and staff responses:
- Reynolds dug into THC and/or human consumption testing (audio - 1m).
- Wise asked about WSDA’s target number of labs (audio - 1m).
- Mann inquired about the expected number of samples (audio - 2m).
- Deyman wanted to know about the geographic distribution of labs (audio - 3m).
- During the RFQQ review, Mann asked about specifying the lab’s physical address on applications as contrasted with their administrative office (audio - 1m).
- Scoring of qualifications led to various inquiries from vendors:
- Deyman asked if producers would pay the State or the labs directly (audio - 4m).
- Oostra had a question about arsenic testing before turning to other testing (audio - 2m).
- He suggested that hemp intended for food consumption would “want to be screened for pathogens” such as salmonella, E. coli, and “mold counts.” Oostra continued, suggesting cannabidiol (CBD) content testing would be desired by many producers.
- Andrusak responded that WSDA would “be asking for that as well” and recommended that vendors include the “cost basis” for additional testing they anticipated hemp producers might ask for in their proposals. Deyman added testing for mycotoxins should be expected, and Andrusak noted that it fell under voluntary testing for human consumption (audio - 2m).
- Oostra had a question on required methodologies (audio - 1m).
- The group turned attention to the RFQQ’s supplemental materials, starting with Exhibit A, Testing Protocols.
- Wise spoke up via chat to raise the issue of required drying of samples (audio - 2m).
- She pointed out that WSDA’s cannabis testing protocol differed significantly from the I-502 requirements of the Washington State Liquor and Cannabis Board (WSLCB). She asked, “do we have to have a separate validated method” for “drying protocol and sample prep?”
- Furth replied that “once there’s a team of labs” contracted they’d form a “lab working group” under an expectation that the competing businesses would collectively “work through those protocols to ensure that everyone’s conducting the drying and testing consistently.”
- Andrusak clarified the process was sourced from USDA’s testing protocols and acknowledged their difference from the “502 state operations going on.” (audio - 4m)
- Labs would accept hemp samples from WSDA field inspectors who collected and transported the wet, harvested material to maintain a documented chain of custody. Upon receipt, labs would be expected to remove “stems and seeds and twigs” before separating the sample into “test specimens” and “retained specimens” which state vendors would be responsible for storing for an as yet undetermined amount of time.
- Andrusak said the protocol required labs to “dry [hemp samples] to between the five and twelve percent moisture basis before any kind of testing is performed or before the sieving happens,” pointing to page 25 of the RFQQ for further details. Reporting would be affected by emailing COAs to the Department.
- WSDA would require labs to be capable of responding to producer requests to “retest” failed samples using retained specimens or provide those back to WSDA for testing at a state lab.
- Wise asked about expected sample sizes, as labs might not have “the capacity to dry a lot of wet material.” Furth said that “the size will be basically enough to fill, probably a paper lunch bag size.” (audio - 1m).
- Multiple references WSDA staff made to sample sizes corresponding to the size of a paper lunch bag were literal expectations as documented on page 3 of the RFQQ: “WSDA Field Inspector shall seal each paper sample bag and record the sample identification number.”
- During the February 20th Cannabis Science Task Force (CSTF) Steering Committee meeting hosted by the Washington State Department of Ecology (DOE), the subject of cannabis sample containers received by laboratories was brought forward by the Analytical Testing Work Group. The early usage of paper bags to collect and transport cannabis samples by WSDA field inspectors was abandoned after recognition that cross-contamination frequently occurred. A motion was put forward and adopted stating, “The sample shall be in a single shoulder-less glass jar, or a single centrifuge tube.”
- Wise had a question about the measurement of uncertainty (audio - 1m).
- Deyman wondered about “large field” samples which could be “way beyond the lunch sack” (audio - 1m).
- As sampling size was based on acreage, Andrusak noted that WSDA would have to consider “what lab would have the capacity to test for” larger potential harvests. She expected such fields would “typically tend to be located in eastern Washington...specifically the Yakima valley region” but observed that there were “not too many producers that are producing on hundreds of acres” at that time in Washington state.
- Read USDA Sampling guidelines for hemp growing facilities and the agency’s Hemp Sampling Training.
- Wise inquired about representative samples (audio - 2m).
- Reynolds asked whether the Department would be “defining how we need to store those samples, as well as how long we need to store them, and much we need to store?” Andrusak said that was “something that we’d want to collaborate on” and find something agreeable to both labs and hemp producers “for retaining samples” (audio - 1m).
- Short- and long-term storage of cannabis testing samples was another issue raised by the Analytical Testing Work Group of the CSTF during the Steering Committee’s second meeting in September 2019. At their October 2019 meeting, the Committee adopted a motion to “[m]aintain the current United States Department of Agriculture standards for freezers” following a second report from the Work Group which recommended samples “be refrigerated on arrival (4 +/- 2 ̊C) and stored refrigerated when not being tested for up to 72 hours from the time of arrival at the lab. After that samples should be frozen and stored at -30 ̊C or lower. Samples may be frozen sooner.”
- Wise spoke up via chat to raise the issue of required drying of samples (audio - 2m).
- Next, the call turned to Exhibit B, Certifications, Assurances, and Executive Order. Blowers stated that Washington “wants to work with honest vendors” who are trustworthy and “not colluding with other vendors” in order to pull off “schemes” or “getting assistance from a current or former WSDA employee” with inside information on the application process. She pointed to an Executive Order from Governor Jay Inslee to “give a small preference” in the RFQQ process “to vendors who don’t require their employees to sign, like nondisclosure agreements” as a prerequisite for employment. This was an effort to help businesses that “allow for freedom of speech for their employees.” (audio - 2m)
- Following that, Andrusak reviewed Exhibit C, Hemp Program Laboratory Qualifications Acknowledgments. The series of signed acknowledgements were positive affirmations that applicants understood WSDA’s requirements and expectations, in addition to disclosing any additional testing methods relevant to the RFQQ for which they were accredited (audio - 1m).
- Blowers spoke to Exhibit D, a Sample Contract. She asked that vendors speak up if they “have any issue” with the provisions in WSDA’s sample contract when applying (audio - 3m).
- Andrusak went over questions they’d gathered to that point before opening up a final round of inquiries.
- Blowers began by addressing the sample size topic again, saying that “if someone has whatever number of acreage and they want to actually split” their sample into multiple areas WSDA “would take a sample for each one of those.” This meant that WSDA did somewhat defer to “how many tests the producer is requesting.” For large fields, Blowers claimed that WSDA inspectors would try to “pare that down a little bit so it's not just a huge sample.” (audio - 3m)
- Reynolds asked about the COA format (audio - 2m).
- Oostra wanted more information on how WSDA was “going to weigh out an ISO accreditation with pricing?” (audio - 3m)
- Wise followed with a question about ISO accredited methods for THC testing (audio - 5m).
- Deyman asked if the hemp producer or WSDA selected the lab to perform testing (audio - 2m).
- Wise asked if labs “need to agree on methods” adopted by the hemp lab work group and “all need to be the same” in order to participate. Allenton said “the testing protocols should be consistent.” She noted that the Department had been working exclusively with Spokane-based Trace Analytics during the 2019 harvest and welcomed their guidance (audio - 2m).
- Mann was curious about what happened in the event contracted costs shifted, as could be expected if the work group adopted different shared methods (audio - 2m).
- Furth returned to the subject of sample size to see if any vendors needed clarification. Reynolds commented that an “expected weight per sample” based on grower size was an “important decision factor.” Allenton promised to “work on that." She acknowledged WSDA “flooded” Trace Analytics with “a big bag” of sampled hemp in 2019. She again anticipated that the minimum amount would work out to a "brown paper sandwich bag." (audio - 3m)
- Mann followed with a question about representative samples (audio - 3m).
- Oostra sought a better understanding of moisture content and whether the Department wanted to address it “post drying or on the raw material.” Andrusak responded that the protocol called for a ratio of 5-12% moisture content in otherwise dried material, adding that “the basis there is we want [all] the samples” to have the same moisture content when they receive testing. Oostra noted that “if we’re going to calculate on a dry weight basis I need moisture, and I’m going to run a dried sample and to calculate dry weight basis I would have to run moisture on the dried sample to see what the difference is.” (audio - 2m)
- Mann asked whether labs needed a moisture analyzer or “to dry things to a constant weight?” Allenton said it was more an expectation of drying “to a specific moisture” but added that she would check with the WSDA’s lab. Oostra cautioned that he’d need a “post-drying value” in order to calculate “on a dry weight basis.” Allenton said labs could “determine moisture content or dry to a specific weight.” She felt this would be another issue tackled by the lab work group (audio - 2m).
- Zitzer spoke up to describe the sampling approach at Trace Analytics. When they would “get all the samples in,” they found some had moisture “north of 20%, so we would air dry them.” This could take “10 days to get [samples] to a workable” moisture content before testing could be performed. The company was trying to meet the USDA’s “turnaround time” for delivery of COAs and “working out a methodology to use a vacuum oven” for quicker drying. Oostra noted that his lab used “freeze drying” to reduce moisture content “within a day” but had also used a vacuum oven. Zitzer said ”to get a faster turn time, we'll be burning off” certain terpenes and focus on the mandatory total THC concentration level (audio - 5m).
- The final question came from Wise about the hemp lab work group timeline and “where it fit into that table on page six” of the RFQQ. Allenton said the hemp lab work group would be an “ongoing thing over the life of our contract.” Blowers confirmed the group would not convene before labs had been awarded contacts and could develop a “cadence” in scheduling meetings (audio - 1m).
- Questions on the RFQQ and staff responses:
- Closing out the meeting, staff encouraged feedback to continue ahead of the first round of proposals due April 10th.
- Blowers thanked the participants, observing that hemp was “a whole new thing” for WSDA and the Department continued to learn throughout the process. She said that remaining questions on the RFQQ were best submitted “in writing” to ensure they were included in the Department’s recorded feedback which would be featured on WSDA’s Contracts and Procurements webpage and distributed over their hemp listserv. Andrusak deemed the call “a very good discussion” and asked vendors to email Blowers with RFQQ questions prior to submitting applications (audio - 2m).