WA Hemp in Food Task Force - Meeting
(October 26, 2022)

Wednesday October 26, 2022 1:00 PM - 3:30 PM Observed
Washington State Department of Agriculture (WSDA) Logo

During the 2022 legislative session, the Washington State Legislature passed a budget proviso directing the Washington State Department of Agriculture (WSDA) to appoint a Washington State Hemp in Food Task Force. The task force made recommendations to the Legislature about regulations and guidance for hemp in food. Those recommendations were due to the appropriate legislative committees by December 1, 2022.

https://agr.wa.gov/departments/food-safety/food-safety

Observations

Task force members discussed drafting their report due to the legislature on December 1st before talking about what cannabinoid limits they’d recommend for hemp in food.

Here are some observations from the Wednesday October 26th Washington State Hemp in Food Task Force (WA Hemp in Food Task Force) Meeting.

My top 4 takeaways:

  • A conversation regarding the ongoing drafting of the group’s legislative report resulted in members raising a few questions about progress on the document.
    • WSDA Produce Safety Program Management Analyst Jill Wisehart communicated that McLain would be “jump starting the process…by the end of the week and then I imagine it'll take a few days to work the magic on the report.” Though unsure of the review time needed by members, she stressed that writing on the document was “underway” (audio - 1m).
    • WA Hemp in Food Task Force facilitator Steven Byers had Wisehart confirm that she was “still waiting” on some task force recommendations (audio - 1m).
    • Stella urged inclusion of details about meetings like any minutes, or emails about their scheduling to highlight what the task force had accomplished. Wisehart agreed, and Byers said details for their last several meetings had largely been “reporting out from the subgroups…so there was quite a flurry of documentation early on and then less so as we've gone on.” Wisehart said she’d identify where in the draft additional details were needed, or a “context statement or two” (audio - 3m).
      • Verda Bio CEO Jessica Tonani felt the only thing unresolved was “down to the…concentration recommendations at this point.”
      • Bonny Jo Peterson, Industrial Hemp Association of Washington (IHEMPAWA) Executive Director, had been under the impression “from what Kelly said, the last meeting, and another conversation, was that she had already began a lot of the report compiling as well as some of…the reasoning”
    • McLain explained that she’d “drafted about 55 or 60% of the report. My goal is to get the rest of it to Jill by the end of this week and then to build the recommendations section out using…the new table that includes concentration information.” Her intention was to have a final draft of the report “no less than five business days in advance of our meeting on November 16th, so people can have a final chance to weigh in.” Naming some of the sections in the report outline, McLain said task force members and their affiliations would be listed, both “so people know who they can talk to, but also for recognition of the time that you all have put in” (audio - 2m).
  • The final issue from the Concentration and Safety Work Group—recommended concentration limits on cannabinoids for hemp in food as well as dietary supplements—led to a bevy of questions as the group struggled to reach consensus.
    • Tonani wanted to review “draft recommendations on the milligrams [mg] and have a discussion with the larger group on whether there's any questions, modifications, and kind of the justification behind where the numbers came from.” She explained how WSDA staff put together “a table for us with the CBD rules and limitations that other states have in place as well as different regions” from which the work group “compiled some of this information into more aggregated forms” (audio - 8m).
      • Tonani reported work group members then met and looked at “what was the lowest allowances by regions within the data that we got” as well as “the higher thresholds.” She talked about how they’d separated this into hemp in food, “which we thought would have smaller package limits, and be more applicable to kind of what you would think of as a standard food, maybe a bar, a beverage, something like that.” Tonani said the other product type was “a dietary supplement which may be more analogous to a tincture or a capsule” which she considered “a little bit harder to package in smaller levels and they also happen to be a little bit less attractive to children.” Concerns she’d heard for supplements included “putting too much of this in a single package.”
      • Looking at the “lowest example, within a region, for CBD in food,” Tonani described how the group then evaluated “Class B, which was essentially impairing, and we looked at the highest” limit, developing another table containing “proposed numbers [for cannabinoid limits that were] open for…the group for discussion.” She noted the lowest limit was in New York, “and that’s 25 milligrams per serving.” The highest limit had been identified in research from the University of Sydney Lambert Initiative for Cannabinoid Therapeutics, which posited in a 2022 research article that “they believe anything below 300 milligrams of CBD is not considered a therapeutic concentration.” Tonani had seen that 200 “to 150 milligram was the limits that Canada and Australia hit; Lambert said 300,” and members felt an entire package should have less than a therapeutic dose. Additionally, “prior we had discussed having two servings per package so that we would set the limit at 150 milligrams of CBD and 300 milligrams per package,” she remarked.
      • As for the proposed Class B group of cannabinoids (“anything that has the potential of getting someone high”), Tonani named delta-9-tetrahydrocannabinol (delta-9-THC) and delta-8-THC as examples. She noted how Michigan “had set one milligram per serving, that was the lowest limit that we could find out there.” Other standards varied, indicated Tonani, “Alaska has 50 milligrams, Louisiana has eight milligrams per serving,” and most “states defer to the 0.3[%] level” - though she doubted this was “the direction that the state of Washington wants to go.” She commented that the work group “thought the 2.5 milligrams per serving [of Class B Cannabinoids] was a limit that…had a low potential of getting somebody impaired.”
      • Moreover, Tonani stated “the percentage of impairing and non-impairing cannabinoids” arose as an important factor for them, as “having a high amount of non-impairing is important, and so…part of this recommendation also recommended that there's a minimum ratio of 20-to-1” Class A to B compounds in a serving of hemp in food, or “less than 5% of the total cannabinoids can be impairing, or Class B.”
      • Tonani summed up their recommendation as “two servings maximum of 300 milligrams of CBD, and maximum of five milligrams of an impairing compound within that package” before inviting feedback from members.
    • Stella thought “the levels of proposed CBD…are too high.” He said that 5mg of Class B cannabinoids strayed “into the zone of what was tested into the clinical trial, and which actually produced a tiny bit of side effects.” Stella was especially concerned since “actually young kids are more sensitive to the Delta-9-THC. So low dose…might still have some impact on the younger population” (audio - 2m).
      • Stella was more supportive of the 20-to-1 ratio, but didn’t understand “what is the rationale to put so much of this THC in there if the expectation is that it's not going to do anything.” Instead, he wondered about having officials be “conservative and maybe align oursel[ves] with what New York did, especially if there's no real justification of why are we going to put…so much CBD in serving[s]” of a non-medical product.
    • Brad Douglass, Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry, asked Stella about the reported side effects, who replied that he needed to review the literature. Stella recalled how “using actually 300 milligrams per kilo for the anti-seizure effects…while it had some therapeutic effects for these kids with seizures, it also had some notable side effects.” Stella was also “not very convinced by the Lambert paper. Basically, I think they were very non-conservative,” but he promised to look at existing research more closely  (audio - 1m).
    • For Tonani, the Class B limit would account for “full spectrum” products containing an assortment of cannabinoids, and “this 2.5 milligrams would be kind of the threshold to have a full spectrum product with about a 50 milligram dose.” She also believed there was research using “2.5 milligrams per kilogram, and dosed up to 25[mg],” leading Stella to call for figuring out “the average weight of these kids so that we can actually have a total dose per day” (audio - 1m).
    • McLain inquired “why the number from New York is too low” and was considered “not appropriate” whereas “the number that is being proposed is six times” that rate. She went on to suggest “hav[ing] these levels set for a certain amount of time in statute, and then they could be adjusted in rule.” Her concern was similar to Stella’s: “if we set it too high to begin with in statute, then…we've got a problem that we can't actually stop” (audio - 3m).
      • Tonani understood her point, emphasizing that the Lambert research paper had been a more recent datapoint, while “we also had some feedback that potentially the 25 milligrams in New York… didn't have the same amount of data that we have today.” Saying Canada and Australia allowed 200mg and 150mg of CBD, respectively, Tonani argued “there's been additional evaluation since” New York’s standard was adopted.
    • Stella asked if there was an “advantage” for the hemp industry to allow 150 mgs of CBD per serving. Tonani responded that there was “no disadvantage” if their “producers wanted to have the ability to…compete in a national market. We want to make a safe product…but…just setting it lower to set it lower didn't make sense” (audio - 2m).
      • Lukas Barfield, Quality West Cannabis (QWC) Owner, mentioned his reporting that the medical cannabis market was projected to grow to $40 billion by 2028, and other countries “all over the world [were] making moves to start doing this and your question is how will this benefit the hemp industry in Washington? If…we have a 25 limit nobody's gonna buy the product. I mean...some people will but it's gonna put Washington processors at a disadvantage.”
    • Procedurally, Douglass asked McLain if a 200-300mg limit of CBD was ultimately recommended by the task force, whether WSDA leaders could “choose to pursue a lower limit….How does that work?” (audio - 4m)
      • McLain answered that “the recommendations and the report are not tied to any regulatory framework right now,” and concerns raised by members would be added to the final report. The group recommendation “could be used by task force members or other members of the public to move forward with a bill,” at which time McLain anticipated WSDA officials could “testify about whether or not we feel those numbers are appropriate, or whether or not we would counter with a different number, and so through the legislative process that number could absolutely change.” Her hope was for suggestions “not only that the industry can live with at least for right now, but also, that aren't going to hurt the industry in the long run.” Her fear was that “you get a hundred and fifty now and we find out it should have been a hundred and a legislator comes in and wipes the entire hemp and food program off the table after it's already been created.” McLain encouraged finding a “strategic way” to push for hemp in food “so that you don't end up five steps back.”
      • “I don't know right now that the agency can [support lobbying] around 150 milligrams per serving,” acknowledged McLain, indicating “the most I've ever seen is 50 in any product that I've seen sold in Washington, even though they're not supposed to be sold here.” She felt that since regulators and policymakers were “building the plane while flying it…just be aware that that can backfire.”
      • Tonani felt the work group had been "cognizant of that," pointing to statements by Canadian health officials that 200mg of CBD a day was a non-therapeutic level, and saying that a discussion about a concentration limit that would “go with the science” was “worth having.”
    • Douglass’ perspective was that the task force was “focused mostly on answering the questions ‘what's a safe quantity?’ And ‘what's a non-therapeutic quantity?’” He asked McLain if the report needed to reflect “the likelihood of policy passing …triangulating with other states” or other issues (audio - 2m).
      • McLain responded that they didn’t need to include those factors, but she wanted to be clear “while we have tunnel vision on, this process and the outline that was given to us in the budget, there's this whole other step that comes after this.” She described how she and Peterson had “talked a lot about, and have been through the trenches every single session…in this space…I want people to be aware that those numbers can change dramatically,” pointing to the shifting language around cannabinoid regulation legislation from WSLCB in 2022.
      • In pesticide policymaking at WSDA, McLain relayed that when “a number that looks like it's safe for a grown adult” was offered, staff do a “1/20th of the LC 50 [lethal concentration, 50%] reduction for children” and if “products are gonna be available to kids on the shelf, you know, it's 1/20th of the level. That would be okay for adults…so these numbers would be dramatically different based on that type of evaluation.”
    • Wise brought up that there were already “all kinds of things available to children to buy off the shelf that we know are linked with bad health effects, red number 40 is a big one of them. It's linked to hyperactivity in children, and it's in all kinds of food directly marketed at children.” To her, the odds “of children actually buying these types of products or ingesting them in large amounts” should be evaluated alongside how to allow “a good economic market here in Washington state” (audio - 4m).
      • McLain reiterated her view that they should be conservative in their recommendations. She conceded that “based on my conversations with the State of New York, that 25 milligrams per serving is not based in sound science.” It was a political compromise, and McLain believed that “this legislature is not that different than the one in New York.”
      • Peterson encouraged a “sledgehammer approach,” starting with a large number before negotiating with lawmakers and trying to end “up where you were comfortable with to begin with.” She wanted Stella to “look at the Lambert study as well as what he wanted to read” and argued the group didn’t need to settle on “a concrete number today, necessarily.”
      • McLain disagreed, “if you guys want recommendations that are quantitative in the document, then the consumptive totals should try to be in the report today unless we're going to plan on November 16th to take a final vote.” She suggested the group could also avoid defining express concentration limits in the final report.
    • McLain checked to see if the majority of members wanted to make a recommendation on cannabinoid concentration limits, “in some way, shape, or form” (audio - 8m).
      • John Hunt, Full Cycle Extraction Manager, urged having “an initial dosage recommendation, and then second to address the very compelling argument about… losing our competitive advantage to other states.” He suggested Washington legislators “index…our limits in the future to what other states do.”
      • There had been some legislative success adding dynamic factors like the consumer price index or cost-of-living-adjustments, McLain noted, but it was “complicated for [the] Department of Revenue when they do things like that. I think it would be very difficult for us…we'd have to basically contract out to have somebody…run the analysis and find out what the numbers should be.” In her experience lawmakers preferred reviewing set numbers, and she talked about possibly setting an initial limit in law, but requiring WSDA to undertake rulemaking on the limit once they’d completed a scientific review. The high level report legislators had requested of the task force could be more broad, she speculated, addressing topics like where a program should be outlined, “does it live in the statute? Does it live in the rule[s]?”
      • Contemplating a hemp in food pilot program with limited-duration funding, Peterson pitched starting it “at 75 milligrams” per serving with WSDA staff later permitted to “adjust that in rule.” McLain didn’t have a set concentration limit to offer, but in looking at the Canadian limit “maybe a safer spot to be for that recommended pilot would be a hundred milligrams per” serving. That could be “something that will resonate with people” and be well below the therapeutic level of 300 mg.
      • While Tonani had been seeking a recommendation limit that was more scientifically defensible and less of a “gut check," she said the Canadian limit had been based on “whether a product could be used for self-care without a [physician] or oversight.” Though she could “respect” members wanting to adopt a lower limit, she hoped “whatever we do is, is based upon not necessarily a gut reaction to what a number will say” and instead look to “what's going on with the current literature.”
    • Stella sought a better understanding of Canadian health officials’ goal, including whether “they're actually promoting a medical use of this.” Wise explained that Canadian cannabis had a “nationalized legal system” as well as “medical options” for use, and that the statement involved “looking at just general safety of intake of CBD with or without medical oversight” (audio - 6m).
      • Tonani added another factor they’d looked at was “not to violate…the IND [investigational new drug]" status. Douglass continued by stating “the way FDA [U.S. Food and Drug Administration] thinks about it is that it's all about intended use, how a product’s labeled, are you claiming drug or therapeutic claims…if you don't then it can be a dietary supplement. It's less about having no overlap in dosage or serving size.” Further contextualizing the Canadian statement, Wise pointed out that “they limited their safety to 30 days and they sort of indicate you can take 200 milligrams of CBD every day for 30 days. If you were doing it longer than that at those levels, it indicates a larger health problem that you should be seeking health care for with the physician or practitioner.”
      • Stella confirmed that the hemp in food policy they were contemplating wasn’t intended for medical uses, observing that the health officials making the statement were “promoting the medical properties whereas we cannot be doing that which is why the doses should be lower than the medical threshold.” Tonani followed up to say “we do have to be cognizant that it has to have enough in there that somebody's going to want to consume it for some reason.” Douglass remarked that he thought Canadian officials had been “speaking to their Natural Health Products,” similar to “dietary supplements here in the US, and those are intended to be used for wellness applications, not therapeutic indications…but there's obviously crossover with how people use these items.”
    • Byers checked to see if the members felt progress was being made (audio - 5m).
      • Tonani believed their conversation on hemp in food was useful, as “dietary supplements are just larger amounts based upon this base of the serving size.” So if the food serving size was changing, that needed to be settled.
      • Douglass reasoned that "consensus from the task force" around the concentration limits "is going to be the most powerful" statement the group could make. Returning to the safety factor concept raised by McLain, he recommended “1/10th, 1/5th, and that maybe gives a little bit more…room for WSDA and policy makers to work with.”
      • McLain speculated that the task force report could recommend having a limit, but the group could take more time to agree to review and settle on a limit in industry-drafted legislation in 2023. She suggested “in order to get the report in by December 1st, we don't have to have agreed to these numbers yet.” Tonani concurred with the importance of a limit “that everybody can stand behind.” McLain was aware most task force members backed “follow-up legislation to create a program following the recommendations that ideally there would be some type of pilot program in place in the statute that has either a sunset clause or a phase out” after WSDA set up a permanent program in rules.
    • Stella was of the opinion “that this number can be really nailed down to a closer consensus within a week” and he wanted to “maybe actually even present what I've found to the group” the following week. Tonani and Wise were in favor of that approach, and McLain suggested that they could meet by the 16th to hammer out any other report alterations (audio - 2m).
    • Turning to dietary supplements, Peterson was curious if McLain had an opinion on what state entity should have oversight over them. McLain said she was meeting with DOH representatives the following week and it was possible the supplements would be regulated through the Washington State Board of Health (SBOH). She wasn’t certain and promised to follow up after her meeting (audio - 1m).
    • Stella returned to the limit on Class B cannabinoids, unsure why a limit of 2.5mg was chosen. Tonani related this to a 50mg full spectrum cannabis product with a 20:1 ratio of CBD to THC which worked out to 2mg, plus some “wiggle room.” Additionally, “we couldn't find a strong push for a drastic change in impairment between the two to 2.5[mg],” Tonani explained to the satisfaction of Stella (audio - 7m).
      • Tonani further clarified that the work group had used percentages to describe the 20:1 ratio out of a belief “we just had questions around as far as educational purposes which might be a little bit easier to digest.” Peterson promised to stay aware of that issue when it came to drafting legislation, but she had concerns that legislators would confuse the 5% mention with the total weight of a hemp product.
      • Stella noted that some legal cannabis products already used ratios in labeling for informational purposes, figuring that “some of the individuals that'll be interested in the CBD products have some understanding of the I-502 system and therefore they might actually really be already used to the 20:1 ratio.” Wise agreed, claiming that ratio also reflected the typical amount of CBD in cannabis plants.
      • Contemplating the amount of servings in dietary supplement containers, Tonani had assumed “60 servings in that,” but the “math gets a little bit more intimidating for regulators.” She elaborated, “if you have a 20-to-2 plant” with “60 servings essentially in two ounces,” the resulting product had “between a hundred and 150 milligrams of impairing” cannabinoids per bottle. “Oregon is at a hundred milligrams per container, for context,” she mentioned.
      • Pulling up their spreadsheet for calculating concentration limits, Wise reviewed possible dietary supplement sizing, “and if we say that we have 50 milligrams per serving that totals 2650 in the bottle and…if that's a 20-to-1 ratio that leaves 132 milligrams of impairing compounds” (audio - 3m).
    • “Is WSDA thinking about, and should we be thinking about as a task force, perspectives like LCB’s,” wondered Douglass. As they considered legislation on the topic, the agency held a “very important opinion…how important should it be for us right now?” (audio - 3m)
      • McLain encouraged the task force to make the best recommendations they could, “and when those don't align—which they won't—with LCB’s recommendations, then that's something for the legislature to figure out.” She advised members “go with your gut, go with your science, and then…be prepared for” the legislative process.
      • Peterson said she had been meeting with WSLCB representatives and that those conversations would continue as she tried to “convince them why they don't need to regulate hemp.”
      • Tonani reasoned that if they could get a state hemp in food system in place, “we’re eliminating a lot of this synthetic market, which is I think the largest risk to youth.” She wanted policy that resulted in “a really robust hemp market…that's health and wellness, and not access to recreational products for kids.”
    • On limits for Class B cannabinoids, Stella asked how they would compare with the limit for cannabis edibles. McLain answered that WSLCB staff had been “using different information…and they've acknowledged that the ratio makes a difference. I don't know that it's fully reflected in what they've sent into the governor's office for consideration yet…I haven't had a chance to brief LCB yet on what this will look like” and wouldn’t before the report was finished (audio - 1m).
    • The final question from Stella related to how much THC could be in a food item before it was regulated by WSLCB. Tonani told him “as long as you have traceability, you can sell it into the 502 system. If there’s no THC in that product it cannot be sold in an I-502 store.” McLain further clarified that “there's restrictions on the inclusion of hemp derived products into the 502 system, but there's no way for a 502 plant to get out of the 502 system” (audio - 3m).
  • WA Hemp in Food Task Force facilitator Steven Byers helped schedule the task force’s next meeting on Wednesday November 16th for members to sign off on their legislative report (audio - 3m).
    • Though Byers was uncertain if a lengthy meeting would be necessary, McLain said it would be the final chance to “hash it out” if there were still disagreements.
    • The Concentration and Safety Work Group planned to meet the day before on November 15th to go over the recommendation limits a final time. Tonani suggested all task force members, not just those on the work group, were welcome to participate.

Information Set