WA Hemp in Food Task Force - Meeting
(October 19, 2022) - Summary

WA Hemp in Food Task Force - Draft Recommendation - Hemp Extract

Task force members tweaked work group recommendation language and planned for an additional meeting before their advice would be formatted for lawmakers.

Here are some observations from the Wednesday October 19th Washington State Hemp in Food Task Force (WA Hemp in Food Task Force) Meeting.

My top 3 takeaways:

  • The Definitions Work Group described revised recommendations, which largely hewed to existing definitions in statute, and fielded several inquiries from the group.
    • Verda Bio CEO Jessica Tonani announced that the Concentration and Safety Work Group was trying to “weave in” definitions into their work. WA Hemp in Food Task Force facilitator Steven Byers invited Washington State University Center for Cannabis Policy, Research, and Outreach (WSU CCPRO) Director David Gang to speak to the recommendations out of the Definitions Work Group (audio - 4m).
    • Gang explained that “we decided that most of the definitions that we need for a bill are going to be standard, taking other parts of the current [Revised Code of Washington] RCW, but there were a couple that needed to be a little bit more clarified that were specific to the hemp in food concept.” The first of those he identified was “what is an ‘extract,’ versus an ‘extraction,’ versus other types of products that might be derived from hemp,” he said.
      • Gang pointed to the definition in RCW 69.07.010(12) where “Hemp extract” was defined as “a substance or compound intended for human ingestion that is derived from, or made by, processing hemp. The term does not include hemp seeds or hemp seed-derived ingredients that are generally recognized as safe by the United States food and drug administration (audio - 3m).
      • He suggested that Tonani, himself, and Brad Douglass, Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry, had found that “it needed a little bit of revising…specific to the way that a chemist would look at it and that a food product regulator would probably look at it.” An extract would be something “produced by” and “extracted out” of hemp, Gang stated, “whereby naturally occurring components are removed from the hemp plant…typically it's done with a solvent.”
        • Their draft defined hemp extract as “a substance, compound or mixture of compounds intended for human ingestion that is extracted from hemp. Extracts can be diluted, concentrated or more purified compared to the original form. Does not include:
          • (i) chemically transformed compounds, except for those that result from the application of heat, light, pressure or change in pH; 
          • (ii) any food (including hemp seeds), food ingredient or food additive that is generally recognized as safe pursuant to federal law; 
          • (iii) any extract derived from hemp that is not intended for human consumption.
        • Gang relayed how work group members thought a “natural process that would potentially change compounds if you just let the plant sit would not be something that we would want to prohibit,” but “artificially changed or transformed” extracts wouldn’t be permitted.
      • Tonani reported that they were calling for removal of “change in pH” in the existing definition, as well as being “specific to oral ingestion.” She said the language “really does narrow down the products” by removing any already generally recognized as safe (GRAS), “anything that might be synthetic,” and anything “that may be considered high THC [tetrahydrocannabinol]” (audio - 1m).
      • Amber Wise, Medicine Creek Analytics Science Director, further elaborated that the “change in pH" wording merited removal considering “the way that Delta 8[-THC] is synthesized just by adding a little bit of acid to [cannabidiol] CBD. So, if I was reading this as a chemist, I would be like, ‘oh well, delta 8 is fine because I can change the pH.’” She included that specifying oral ingestion was useful so the definition was clear “it wasn't, like, inhalation products” (audio - 1m).
    • Next, Gang went over their definition for a proposed cannabinoid classification system splitting the compounds into Class A and Class B (audio - 3m).
      • “Class A cannabinoid means all cannabinoids that do not meet the form and function of Class B cannabinoids.
      • Class B cannabinoid means is a substance that meets the following structural and functional criteria:
      • (i) The substance exhibits the structural backbone of tetrahydrocannabinols and tetrahydrocannabinol-like (THC-like) molecules that include the interconnected three-ring system of a: Six-carbon aromatic ring; pyran ring; and cyclohexene/cyclohexane ring. Known compounds that fit the description provided in this subsection (3)(d)(i) include:
        • (A) Tetrahydrocannabinols – a single double-bond in the C ring:
        • (B) Hexahydrocannabinol – no double bonds in the C ring
        • (C) Carboxylates (C-2 and C-4) of tetrahydrocannabinols or hexahydrocannabinol:
          • (I) Delta-9-THC acid (Delta-9-THCA);
          • (II) Similar carboxylates of Delta-9-THCA for tetrahydrocannabinols in (d)(i)(A)(1) through (6) of this subsection; and
          • (III) Carboxylate esters in (d)(i)(A)(1) through (6) of this subsection; 
        • (D) Alkyl analogues (C-3) of tetrahydrocannabinols or hexahydrocannabinol:
          • (I) Delta-9-THCP (Delta-9-tetrahydrocannabiphorol) and n-alkyl analogues;
          • (II) Similar alkylated analogues of Delta-9-THC for tetrahydrocannabinols in (d)(i)(A)(1) through (6) of this subsection; and
        • (E) Hydroxylated analogues of tetrahydrocannabinols or hexahydrocannabinol:
          • (I) 11-hydroxy-delta-9-THC and 8- and 10-hydroxy analogues; and
          • (II) Similar hydroxylated analogues of Delta-9-THC for tetrahydrocannabinols in (d)(i)(A)(1) through (6) of this subsection;
      • (ii) Possesses significant CB1 agonist activity as demonstrable by binding affinity (Ki) to the CB1 receptors at less than 200 nM; and
      • (iii) Results in positive effects for all four components of the tetrad test in rodents or reliably causes functional impairment in humans as assayed by a method possessing scientific consensus.”
      • Gang summed up Class B cannabinoids as those “things that should be regulated because basically it's what gets you high, or what has the potential to get you high” and was inclusive of “anything that's basically regulated by [Initiative-]502 market fits into this Class B cannabinoid profile,” and didn’t “fit into a food grade component.” He noted that under this system delta-8–THC “would be excluded…even though you could convert it from CBD using pH. It still would not be allowed.” Gang expected their recommendations would set a limit on Class B cannabinoid content in food items and “anything above whatever that regulation limit is will then make it not allowable. Anything below that limit will be allowed.”
        • According to Tonani, the Concentration and Safety Work Group had been engaged in “setting limits for how much of a Class B would be allowed” in food (audio - 2m).
      • Industrial Hemp Association of Washington (IHEMPAWA) Executive Director Bonny Jo Peterson wondered about the terms ‘ingestion’ and ‘consumption’ which both appeared in the definition language. She additionally was curious about adding “time or natural degradation” to the definition mention of “chemically transformed” (audio - 4m).
        • Gang agreed that mentions of ‘consumption’ could be changed to ‘ingestion’ for consistency, but felt “anything that's related to chemical reaction, time is a factor in it by default so it doesn't really have to be called out,” including natural degradation.
      • Peterson said that the work group members had debated “whether we needed a ‘naturally occurring’ definition or we could deal with that in policy.” WSDA Policy Advisor to the Director and Legislative Liaison Kelly McLain replied that "I don't know that I have a preference" (audio - 1m).
    • Sarah Ross-Viles, Seattle and King County Public Health Youth Health and Marijuana Program Manager and a new addition to the task force, wanted to know—as the definition mentioned “concentrates”—about “the concentration of the very, very trace amounts of Class B cannabinoids,” and the potential “interplay” with Class A compounds (audio - 5m).
      • Tonani responded that the mention of concentration involved “looking at, like, concentration of the non-impairing, so something like a CBD isolate, and then we plan on setting for the class B, both the serving size and a package limit.”
      • Ross-Viles commented that “products that I'm wary of that [have] not existed, but could you know come up in a market that allowed for it, is a product that meets the THC limit but is a very small consumable, and a very affordable consumable.” She believed that prevention stakeholders feared that “a dollar a package, even if there's a two milligram limit…two and a half milligrams is enough to be intoxicating for a night” and that a bad actor could enter to the market to “get around the the restricted THC market by just making a really cheap, concentrated product that doesn't have…relative Class A cannabinoids in it, that is essentially..a lozenge or pill, something very small” where “it's clear, the intention is that you actually buy multiple packages and consume them.”
      • Tonani couldn’t see a “mechanism that that could be sold in a package for youth” under their recommendation.
      • Peterson mentioned that requiring a “ratio" of Class A and B cannabinoids in a product had been discussed.
      • Nextraction Vice President of Quality Operations Eric Elgar was doubtful “any of this would be cheap enough, at these levels, to where anything like I think what you're what you, what you're envisioning…I think it would be the most expensive way for a kid to get their THC.”
      • Ross-Viles appreciated the clarification, “that was my suspicion, that just it doesn't make sense.”
  • The Concentration and Safety Work Group reviewed new changes to their recommendations and answered questions covering testing, the interplay of state and federal law, and sunsetting certain provisions.
    • Wise briefed on the latest iteration of the recommendations from the group, which included columns for legislative actions, agency rulemaking actions, and additional information (audio - 3m).
    • Tonani talked about their work to limit “things that people were concerned about, so for example, in the initial definition adding ‘oral ingestion.’ We eliminated any sort of vapor product, or other classes of products,” GRAS products, and by stating “it does not include the chemically transformed, that eliminates…the delta 8s and those concerns.” She continued, remarking that “we also are cognizant that we're really dealing with low THC plants and low THC products…not anything that is encroaching on [I-]502 and it's also not unpackaged goods.” Tonani said “we believe dietary supplements and packaged foods are both also defined in RCWs and [Washington Administrative Code] WACs. We know cannabis, from a high THC perspective, is defined,” and the group remained hopeful the majority of needed definitions were set (audio - 5m).
    • Wise brought up recommendation 3 regarding when safety standards would be put in rule versus statute (audio - 1m).
      • Wise asked about what she framed as a recurring debate over “what we think should be tested for” given that there were already “state level Department of Health (DOH) manufacturing standards and licenses for facilities.” She conveyed that the group felt “we definitely need to have these screened for the cannabinoids, Class A, Class B compounds,” but other testing panels lacked consensus. She further called for removing microbial testing because “if this is food and dietary supplements, there are already sort of microbial screens [and] facility cleanliness requirements required for manufacturing.” Gang agreed that hemp in food “should be treated like any other food or beverage,” with the exception of testing for cannabinoid levels. Peterson and Elgar concurred with the edit to make existing food safety rules applicable to hemp products (audio - 4m).
    • Looking at recommendation 4 regarding product labeling alignment with federal rules in 21 CFR 101, Wise sought clarification on whether the recommendation should go in legislation or subsequent rulemaking. McLain felt it could work in either place, but advised keeping it in any legislation (audio - 2m).
    • Wise also mentioned recommendation 5, which pertained to reconciling state and federal hemp in food laws, to encourage cleaning up the language. Tonani’s understanding was “we have to edit state law to say that CBD is allowed even though it has an [investigational new drug] IND on it.” She was thinking specially about Epidiolex and what might constitute a “therapeutic dosage” of the cannabinoid. Jay Noller, the head of the Oregon State University (OSU) College of Agricultural Sciences Department of Crop and Soil Science, advised saying “non-therapeutic" instead of a “safe” dosage (audio - 5m).
    • The last question from Wise was on recommendation 6, which would “sunset” their state system for hemp in food in the event of federal guidelines “that are favorable to us.” Peterson said there had been consideration of an “alternative starting point program similar to the hemp pilot program" and alleged the idea had been supported by DOH officials (audio - 3m).
  • Task force members went over the particulars of their final recommendations which would be drafted into a legislative report in November for submission to the governor and legislature by December 1st.
    • McLain mentioned working with WSDA Produce Safety Program Management Analyst Jill Wisehart to draft the task force final report draft ahead of a November 16th meeting “when we would agree as a group on whether or not the recommendations are appropriate for the final report.” It would have an executive summary, introduction, and background; and recommendation “buckets.” The report would also include an overview of the task force and work group meeting schedules, she stated, in order to give “a feel for the robustness of the work that's gone into it” (audio - 2m).
    • Tonani voiced being “happy with where the [recommendations] document is,” citing the “legislative versus rules” format, and was optimistic “in the next week or so” they could settle on a “milligram concentration” for products. “Do we even want to deal with setting a limit for the Class A piece,” wondered Peterson, claiming that “the table shows that most states don't.” She was “otherwise...pretty impressed that we got this far” (audio - 6m).
      • Byers asked who would make the remaining edits, to which Peterson answered that there would be additional work group meetings and other members might want to “digest” the recommendations they’d drafted. In advance of the next task force meeting on Wednesday October 26th, she speculated that others would weigh in and then McLain and WSDA staff could “get us that final version.”
      • Byers then assured task force members he’d send out the most recent revisions to all members. Tonani asked that additional input on their suggestions be submitted by Monday October 24th so she could send out a “final draft version” before the Wednesday meeting.
    • Members discussed appropriate formatting, gravitating towards a report with a “recommendation statement,” “outcomes,” and “additional context.” McLain promised to take the language “with the goal of getting you all out a report the first week of November” so that any changes could be made by the December legislative deadline (audio - 8m).
      • Tonani reminded the group that beyond reviewing any submitted feedback, the “only outstanding issue” for the concentration work group was setting “the actual milligram concentration situation” for cannabinoids in hemp foods. After considering “the table that we got this week” and a “really timely paper that came out today" on low-dose CBD, she hoped they could bring numbers for the concentration limit to the wider task force by their next meeting. 
    • Peterson encouraged McLain to address which agency would regulate dietary supplements, along with a potential “pilot program” for hemp in food. McLain stressed that the concept had been discussed in a preliminary sense, and “a pilot program would be something that the state funded to get things underway while we do the rulemaking.” She envisioned a law that directed WSDA “to have a full program in place no later than July 30th” of 2025 after the legislature “appropriate[s] one-time money to do the work in that pilot program.” The idea would be for the program to “sunset” in the event of workable federal guidelines, which McLain compared “with what we’ve done for certified cannabis,” the state level organic-equivalent standard which “exists only in as much as it has to until there's a federally approved process” (audio - 4m).
    • Members further discussed what would be the appropriate master copy of their proposed recommendations (audio - 2m).
    • McLain thanked task force members as she prepared to draft their report, “especially to David, and Amber, and Jessica, and Bonny Jo, and others who've participated with me directly or or in the subgroups, the work you've done is invaluable to me” (audio - <1m).
    • Byers forecast a shorter meeting on October 26th and stated he’d ensure that the relevant materials were disbursed to the full task force (audio - 3m).

Information Set