Two work groups presented draft recommendations to the full task force covering product scope and requirements, as well as definitions for ‘hemp extract’ and classification of cannabinoids.
Here are some observations from the Thursday September 29th Washington State Hemp in Food Task Force (WA Hemp in Food Task Force) Meeting.
My top 4 takeaways:
- One challenge of evaluating hemp in food arose from the practice of converting hemp-derived cannabidiol (CBD) into other cannabinoids, some of which had inebriating effects.
- Over the spring and summer of 2021, some cannabis stakeholders and regulators grew concerned about CBD isolate being chemically converted into synthesized delta-8-tetrahydrocannabinol (delta-8-THC), delta-9-THC, and other cannabinoids by licensed producers. The board issued an interpretive statement in July 2021 which found that“statutes do not authorize a licensed processor to source hemp based product, such as legal CBD, and convert it to delta-9 THC, regardless of the method of production, nor are they licensed to process hemp into marijuana concentrates.”
- Licensed processor Unicorn Brands LLC received an administrative violation notice (AVN) alleging four violations in July 2021 regarding the company’s conversion of CBD into synthesized THC. Unicorn Brands Owner Peter Saladino subsequently filed an appeal.
- Find out more from the WSLCB:
- Licensed processor Unicorn Brands LLC received an administrative violation notice (AVN) alleging four violations in July 2021 regarding the company’s conversion of CBD into synthesized THC. Unicorn Brands Owner Peter Saladino subsequently filed an appeal.
- As the Washington State Liquor and Cannabis Board (WSLCB) investigated, it became clear that converted cannabinoids were available outside of the legal cannabis market in many hemp products sold without age restriction, quality testing, or adequate labeling, though some business representatives asserted the safety and legality of the practice.
- WSLCB leaders then pursued agency request legislation in 2022, HB 1668, which ran into opposition around letting agency staff define cannabinoids that “may be impairing” at a later date. While there was broad agreement to remove hemp products with impairing cannabinoids from outside the legal cannabis sector, lawmakers didn’t pass any new law around semi-synthetic cannabinoids derived from hemp.
- Alternative legislation around defining impairing cannabinoids was backed by some cannabis and hemp trade associations and would’ve classified substances based on structural similarity to THC and how they were assumed to bind with human cannabinoid receptors. Task Force member Bonny Jo Peterson, Industrial Hemp Association of Washington (IHEMPAWA) Executive Director, previously described the delineation between compounds: Class A was “what we know gets you high" and Class B was "everything else.”
- The WSLCB Cannabinoid Regulation rulemaking project was withdrawn on September 14th after concluding “additional definitions related to the production and/or processing of cannabis…should be introduced through legislation.”
- On September 28th, WSLCB staff announced a settlement with Unicorn Brands whereby the agency “agreed to fully withdraw the alleged criminal conduct charge. In exchange, Unicorn stipulates and fully admits to the remaining three violations: Misuse of License, Noncompliant Extraction, and Traceability Failure. Further, Unicorn has agreed to pay the standard monetary penalties for the three stipulated violations, accept forfeiture of the seized products, and waive further administrative review. Finally, Unicorn has agreed to the condition that “it shall not use its license to produce or manufacture Delta-8 THC, Delta-9 THC, or any similar synthetically-produced THC from any hemp-based sources in the State of Washington unless explicitly authorized by a subsequent change in state law that allows the licensee to do so.”
- On Monday October 3rd, WSLCB staff announced the formation of a Cannabinoid Science Work Group which would “collaboratively and transparently explore and build foundational understanding of the ‘. . .plant of the genera Cannabis, as well as synthetic equivalents of the substances contained in the plant’ (see RCW 69.50.204(c)(30)).” The announcement included a draft charter intended to formalize the group’s scope and purpose - an organizing technique not utilized in the formation of previous work groups nor the Cannabis Advisory Council. The new work group’s responsibilities “may include…Providing recommendations on potential guidelines for safe methods of manufacturing, extracting and synthesizing cannabinoids.”
- Over the spring and summer of 2021, some cannabis stakeholders and regulators grew concerned about CBD isolate being chemically converted into synthesized delta-8-tetrahydrocannabinol (delta-8-THC), delta-9-THC, and other cannabinoids by licensed producers. The board issued an interpretive statement in July 2021 which found that“statutes do not authorize a licensed processor to source hemp based product, such as legal CBD, and convert it to delta-9 THC, regardless of the method of production, nor are they licensed to process hemp into marijuana concentrates.”
- Seven recommendations from the Concentration and Safety Work Group were debated and modified by task force members.
- Recommendation 1:“Product Scope is limited to ‘food’” (audio - 1m, audio - 1m)
- Concentration and Safety Work Group member Jessica Tonani, Verda Bio CEO, suggested a “proposed legislative action would be to limit the scope of products to packaged food products and not unpackaged food products.” Such a proposal would also “prevent synthetics, we all agree that those are out…these are things like the delta-8s [and] delta-10-[THC]s of the world,” she said, as the work group found science around those compounds was “growing or evolving.” Tonani also indicated the work group would recommend defining “allowed processing methods” for hemp in foods, as members understood the Washington State Department of Agriculture (WSDA) “generally has, for food processing, allowed methods.” They advised mandating use of these methods through WSDA rules, she added.
- Joy Beckerman, Hemp Ace International Founder and Colorado Hemp Works Senior Advisor and Co-Founder, inquired around the distinction for “packaged foods,” which Tonani articulated as permitting “a canned beverage with hemp extract in it, but you could not, for example, make a drink at Starbucks by adding a shot of hemp extract.” Reassured, Beckerman had “thought that this might be leading into…the sort of microgreens farm-to-table type thing” (audio - 1m).
- Next, Beckerman wondered about a “proactive” ban on “cannabinoid hemp products in the unpackaged food” because “many states have an actual outright prohibition against that.” Tonani responded that the work group members were under the impression that “this wouldn't necessarily prevent, for example, microgreens or something, they could be packaged” and sold, however it was “not today within the scope of our work group” to resolve concerns over on-site dosage of products (audio - 2m).
- John Hunt, Full Cycle Extraction Manager, wanted to know how regulating agencies would determine allowable methods for food processing. Tonani explained that aspect of the recommendation “really became an issue mostly with synthesis” of cannabinoids, a concern “around using hemp to produce other compounds…we wanted to make sure that there were rules around prohibition of some of those methods.” She conveyed that approved extraction methods were also encouraged in line with other food processes “as long as you could prove that it was safe.” Beckerman’s take was that once there was a “definition for either ‘synthetically modified plant constituents’ or ‘artificial cannabinoid’” in either rule or law, the policy would “preserve the ability for the hemp extract industry to…put forth [cannabinol] CBN products” and not “specifically exclude” the compound from hemp products. Tonani concurred they were attempting to head off “new processing methods” and empower WSDA officials with flexibility through “the allowances in rules…versus having to go to legislature for the processing methods” (audio - 4m).
- Beckerman commented that stakeholders and regulators would “maybe have to address synthetics in law” before WSDA staff exercised rulemaking authority over synthetic cannabinoids. She stressed that “the definition we're proposing for hemp extract, which surely needs to be in the law, specifically excludes synthetically modified plant constituents.” Tonani agreed legislation on that point was needed, describing the consensus of work groups members to collaborate with the Definitions Work Group on “questions around whether the definition of impairing would encompass a number of the really true synthetics or whether there should be some flexibility moving forward for WSDA or DOH [the Washington State Department of Health] to expand that list.” Beckerman predicted that Definitions Work Group members would “strongly and unanimously” agree that the task force didn’t “want to define ‘intoxicating,’ ‘intoxication,’ ‘impairment,’ ‘impairing,’ we want to define Class A and Class B” cannabinoids (audio - 2m).
- Hunt asked in the chat how definitions would impact processing methods, prompting task force member Eric Elgar, Nextraction Vice President of Quality Operations, to wonder aloud about defining appropriate methods. He noted his company used “a water based extraction method here, and I…want to make sure that that gets allowed.” Tonani wanted the task force recommendations at “a high level” followed by “defining and making sure that the rules meet…standard extraction methods and things like that.” Hunt observed that “having a fallback with the state of just having a [certificate of analysis] of the material should be adequate,” and Elgar agreed. Beckerman chimed in to say “we don't want to diverge too much from federal law and what's allowed for processes for food and dietary supplements.” Tonani felt that defining allowable processes could impact “personnel safety” and “the group did feel that that was an important thing to have in there” (audio - 3m).
- Recommendation 2:“State will establish 2 product categories” (audio - 2m)
- “Proposed legislative action: Two product categories will be defined (Packaged Food and Dietary Supplements)
- Packaged Food: Edible food* and beverages*
- Dietary Supplement* Dosage Forms (full spectrum essential oils (i.e. tinctures), tablets and capsules)- potentially higher dosage allowances”
- Tonani commented that “one of the major reasons that we attempted to kind of separate it in this format was that there are some full spectrum products, especially in the tincture classes, that aren't necessarily products that would be abused by kids, they’re different things like that, and have medical utility and may require slightly higher allowances on the impairing for package size than potentially edible foods.” Since dietary supplements had a definition in law, “we thought that differentiation may allow some of the dosage guidelines.”
- “Proposed legislative action: Two product categories will be defined (Packaged Food and Dietary Supplements)
- Recommendation 3:“Hemp in food will be allowed as long as it meets ‘safe’ guidelines” (audio - 1m, audio - 2m)
- Defining safety of products primarily around “dosage,” Tonani envisioned a system giving WSDA or DOH “the ability to periodically review and modify dosage allowances.” Tonani told task force members that “within rules for packaged food, there would be an allowance that compliance with not to exceed X—and this is a placeholder—milligrams of CBD per serving, and then also not to exceed X milligrams of impairing, or whatever the word is that we use for that, per serving or Y milligrams per container,” along with “a very similar guideline for dietary supplements.”
- The work group was also “waiting for some data to be able to fill in what we believe those safe guidelines should be,” she stated; “the WSDA is working on that and we're also waiting on definitions for the impairing, or whatever word ends up, Class A, Class B.”
- Tonani described how work group members were advising using the term “periodically" for regulators to evaluate safe cannabinoid levels as DOH staff informed them “if we put in ‘every one year’ or ‘every two years’ there would be a very different fiscal note than ‘periodically.’”
- “I would just respectfully request that we say serving size” rather than dosage, Beckerman asked, mindful that “we're not talking about over the counter drugs, or drugs in this law or regulation.” She further advised utilizing “the vernacular that if we were in an [American Herbal Products Association] AHPA meeting or we were in an [U.S. Food and Drug Administration] FDA meeting, they wouldn't be using these terms,” mentioning “they'd say the term ‘delivery method’ as opposed to ‘dosage form.’” Tonani felt that was “probably just me misspeaking" and that the term ‘serving size’ was used in their recommendation (audio - 2m).
- Beckerman established that “we've got the Class A and Class B cannabinoids, which hopefully the group will adopt, which by the way will be groundbreaking and pretty revolutionary if we do that” and “we would certainly say we want a total amount of Class A…the ones with the potential to induce intoxication.” What was less clear to her was “why would we limit it to CBD when there could be a toxic amount of” some other cannabinoid. Tonani answered that “it's important to call out CBD because of the IND [investigational new drug] and we feel like we're going to have to put in a note around why we justify a certain volume of CBD” as non-toxic. Beckerman predicted the law resulting from their recommendations would “supercede New York in groundbreaking by doing Class A, Class B, but I enjoyed what was revolutionary about New York's was that they did total cannabinoids” out of concern for public safety as “there's just so much that wasn't known” (audio - 4m).
- Peterson brought up other cannabis compounds, “lipids and such,” feeling that the classifications would have to be refined. She acknowledged “discussions…for the last couple years around the ratio of…20 [CBD] to 1 ratio to everything” for hemp items. Tonani thought the task force could “dive into that a little bit more" after WSDA staff gathered information on other states’ hemp-in-food policies. WSDA Commodity Inspection Division Assistant Director Jessica Allenton mentioned that Produce Safety Program Management Analyst Jill Wisehart was organizing those levels into a single table and expected they could be sent out within a week (audio - 3m).
- Defining safety of products primarily around “dosage,” Tonani envisioned a system giving WSDA or DOH “the ability to periodically review and modify dosage allowances.” Tonani told task force members that “within rules for packaged food, there would be an allowance that compliance with not to exceed X—and this is a placeholder—milligrams of CBD per serving, and then also not to exceed X milligrams of impairing, or whatever the word is that we use for that, per serving or Y milligrams per container,” along with “a very similar guideline for dietary supplements.”
- Recommendation 4:“Hemp products will require lab testing to be marketed” (audio - 2m, audio - 1m)
- Tonani conveyed that analytical testing was another topic that would necessitate changes in both law and rule, along with requirements being “evaluated periodically and incorporating the best available science.” She said the group found that “this is kind of constantly evolving and we wanted to have the actual rules around what” was required in the Washington Administrative Code (WAC), while having “legislation state that…testing is required.” Testing would “screen for cannabinoids and microbial panel on final/packaged product” and cover “essentially the impairing cannabinoids, CBD, and any other marketing cannabinoid,” she explained. Tonani commented that “if the product is sold not as an extract, then the plant material has to be tested for heavy metals and pesticides. If the plant undergoes an extraction, then the intermediate extraction can be tested for pesticide and heavy metal[s]” because extracts would be where the highest concentration of the substances were present. The “batch” testing of hemp crops “only has to be cannabinoids and microbial.”
- Hunt sought greater clarification around testing cannabis in batches or harvest lots. Tonani told him cannabinoids and microbial testing would happen “at the product batch level,” whereas pesticide and heavy metal recommendations were “slightly different.” Beckerman emphasized that their proposed testing would be in addition to the mandates around food and dietary supplements in the Code of Federal Regulations (CFR) given that hemp was “a commodity that is federally legal, and so the code of federal regulations despite the fact that it does not account for hemp extract, it accounts for food, beverages, and dietary supplements being put into the stream of commerce in the United States.” Elgar pointed to definitions for ‘lot’ and ‘batch’ in 21 CFR 111 and 21 CFR 117, “so any new day certainly, any new process” would be a new batch and require separate testing. Brad Douglass, Spoke Sciences Chief Regulatory Officer and Vice President of Chemistry, emphasized anytime someone was “mixing the ingredients.” Hunt argued this standard “will eliminate any of the small producers for making packaged cookies,” but Tonani wasn’t as certain, as cannabinoid and microbial testing “are substantially lower price” than pesticide and heavy metal panels (audio - 4m).
- Hunt was interested in the reasoning for not doing all hemp testing at an intermediate level. Tonani replied that for microbials, “most of them, I think, are going to be introduced actually like with the quality of” ingredients, and that their work group had learned “from a food safety standpoint [regulators] would like to see that microbial” testing done. Douglass said that “our food supply is a lot less tested than you may think” and had “no actual requirement for microbial, pesticide, or metal testing at the federal level for finished food products” (audio - 3m).
- Beckerman raised the issue of testing for residual solvents and mycotoxins. Tonani answered that Medicine Creek Analytics Science Director and task force member Amber Wise provided “pretty convincing data” that mycotoxins were actually “false positives within cannabinoid extracts.” As for solvents, she remarked that residual compounds “may be specific to whatever processing methods somebody does,” offering the example that rules might be “very different if you're using CO2 versus ethanol” extraction. Beckerman encouraged treating solvent levels as “a thing that should be addressed”; Tonani felt they might be most apt “under the method rules” recommendation and Peterson agreed. Douglass mentioned that Luisa Castro, WSDA Food Safety and Consumer Services Division Policy and Performance Administrator, had shared that her division “does do spot testing of product on grocery store shelves for microbial contamination, but that's on the regulator level and not a requirement of manufacturers.” He further added “if you start mandating finished product levels for pesticide and heavy metals it encourages a manufacturer to sometimes use…hot intermediate products and diluting them in the finished product…it's sort of a negative incentive” to use finished product testing since “you don't want people to think that dilution is the solution to pollution in our food products.” Tonani asked for task force members with strong opinions or information on the subject to reach out to the work group (audio - 5m).
- Returning to the issue of mycotoxins, WA Hemp in Food Task Force facilitator Steven Byers noted Wise had joined the event. Tonani referenced “microbial and mycotoxin testing and there was some questions around whether or not microbial should be spot or not tested, and then whether or not mycotoxin should be allowed, and I said that you had some pretty good insight on why mycotoxins maybe overkill and not necessarily required at a batch level.” Wise laid out how “mycotoxin molecules are, as their name suggest, toxic. Those mycotoxins, the fungus that create them and the molecules that they then produce, are essentially never ever found on cannabis, or their extracts. She acknowledged that mycotoxins did occur in food products, but that typically there were “food safety tests at the facility level, and potentially annual spot checks or something. So that's why we didn't include mycotoxins at the batch level.” She clarified, “if they were to be found in hemp in food products, they would…most likely be coming from other ingredients” (audio - 3m).
- Recommendation 5:“Products will follow WA state food labeling requirements” (audio - 1m)
- Beckerman anticipated existing food labeling rules would need to be amended “if they don't account for milligrams” or “certain potential warnings,” while “dietary supplements are a whole ‘nother level.” Tonani conveyed the goal of the work group to hew to requirements for those types of products, and that there was concern over “what level we put on that” labeling and whether they’d “think of this…as a food and limit the impairing compounds.” As the CFR didn’t “account for cannabinoids or hemp extract products,” Beckerman noted trade associations like AHPA had to determine “what is appropriate here given the fact that the feds aren't accounting…for this level of consumer awareness” because “there are indeed some items that are supplemental to what exists in Washington State food labeling law and in the CFRs.” Tonani stated that work group members “looked back and said ‘what did the consumer need from this?’” Beckerman recommended seeking to “understand what the majority of other states that have labeling requirements are doing” (audio - 5m).
- Tonani asked for clarification on the status of the planned task force Labeling Work Group. Peterson mentioned that they were waiting on guidance from other groups (audio - 1m). Tonani then requested clear agreement on labeling rules, with Beckerman and Peterson lobbying for their recommendations to cite 21 CFR 111, 21 CFR 117, and 21 CFR 101 (audio - 1m).
- Recommendation 6:“Reconciliation of federal food/drug law” (audio - 1m)
- “Proposed legislative action: Allowed ‘articles’ according to x mg CBD limitation defined as ‘safe’ above are NOT considered ‘substantially equivalent’ to the prescription drug Epidiolex due to a 10X minimum difference in dosage/serving size of CBD.”
- Beckerman said this recommendation was put forward “in order to really tie it up and prevent litigation” by modifying a single sentence in existing law to clarify the lawfulness of hemp products.
- Recommendation 7:“‘Sunset’ if federal law changes for hemp in food” (audio - 1m)
- If federal policy “changes for hemp and food,” Tonani said the work group recommended a sunset clause be activated to transition “into whatever that federal law change is.”
- Beckerman asked what if “federal law changes to prohibit this in a formal agency action, or a formal determination.” She said this was among the reasons that “New York’s cannabinoid hemp is [regulated] in” the Office of Cannabis Management, and wanted to know if the group had considered the possibility of market closure based solely on federal dictates. Using the phrase ‘may’ instead could avoid that concern, Peterson offered, and Douglass felt “you could segment it for a positive change versus a negative change” in federal policy (audio - 2m).
- Highlighting the hiring of former State of New York Director of Cannabis Programs and former Cannabis Regulators Association (CANNRA) President Norman Birenbaum by the FDA as “a senior public health adviser to help lead the drug center’s cannabis research and regulation efforts,” Beckerman called him a “prohibitionist” hired by then-Governor Andrew Cuomo as the ‘cannabis-czar’ ahead of that state’s legalization of the plant. She claimed he’d been “significantly frustrated at the whole process of cannabinoid hemp regulation because he was such a prohibitionist” and considered it “very discouraging news that he is being appointed” after being dismissed from New York State government among other “Cuomo cronies.” “The FDA is going in an interesting direction here by hiring Norm,” concluded Beckerman (audio - 1m).
- Tonani welcomed additional input from the group. Elgar, Douglass, Peterson, and Dylan Summers, Lazarus Naturals Vice President of Government Affairs, were all in favor of the recommendations in their current form (audio - 2m).
- Peterson added that “there are existing [pesticide testing] panels and such” that could serve as a “starting point with what's already…in existence, that is already used by the hemp program, and has been adopted by other states” (audio - 1m).
- Recommendation 1:“Product Scope is limited to ‘food’” (audio - 1m, audio - 1m)
- The draft recommendations by the Definitions Work Group would revise the term ‘hemp extract’ and categorize cannabinoids, although members raised concerns about what may be excluded under the proposed definitions.
- Peterson started off with their proposed definition around “hemp extract,” derived from the AHPA “extract definition for dietary supplements.” She also indicated there were relevant definitions in a 2021 law, SB 5372, "Concerning hemp processor registration and a hemp extract certification" that “dealt specifically in regards to human ingestion.” The wording had been “suggested by Lucas” Barfield, Quality West Cannabis (QWC) Owner and task force member, she commented. Beckerman highlighted that “we're not defining a finished product here” and there would be additional definitions “for an in-process hemp extract and certainly a finished product” (audio - 3m).
- The proposed definition stated:“Hemp extract means a complex, multicomponent mixture obtained after using a solvent to dissolve components of the biomass. Extracts may be in dry, liquid, or semisolid form. Hemp extracts are not the same as expressed juices or oils, or pure chemicals isolated from an herb, and do not include:
- (i) synthetically modified plant constituents; [*Notes: (1) We will either define ‘synthetically modified plant constituent’ or a similar term and whatever term in this regard is defined will be the term used here to describe this exclusion; (2) there is a thoughtful proposal to include some examples to this exclusion for clarity, such as ‘…including but not limited to’” delta-8-THC, tetrahydrocannabinol-O-acetate (THC-O-acetate), hexahydrocannabinol (HHC), and tetrahydrocannabiphorol (THCP).
- “(ii) any food, food ingredient or food additive that is generally recognized as safe pursuant to federal law; or
- (iii) any extract derived from hemp that is not used for human consumption.”
- Tonani asked if the definition excluded hemp oils or isolates. Douglass shared that “expressed juices" and "expressed oils" maintained a specific botanical meaning of squeezed plants such as olive oil, whereas hemp extract was “different from that.” David Gang, Washington State University Center for Cannabis Policy, Research, and Outreach (WSU CCPRO) Director, concurred, saying “any kind of seed oil that you squeeze” wasn’t classified as an extract (audio - 3m).
- Beckerman brought up "used for human consumption" terminology, asserting its importance because “we're not dealing with cosmetics here” something that “sort of helps limit the scope.” Gang wondered if they should elaborate on this distinction in anticipation of future legislation dealing with hemp extracts and cosmetics, but Beckerman considered that possibility remote and “isn't necessary. The FDA…regulates the cosmetics” (audio - 2m).
- Wise turned the conversation to what would be excluded under the definition, speculating about including an “explicit statement about allowing these juices, or oils, or pure chemicals.” She continued, stating she didn’t “necessarily love this second phrase at all. I also read it to exclude most of the things that people are using to infuse products.” Wise then asked “are there more definitions coming down that would include those types of things to be used” in making hemp in food products (audio - 13m).
- Beckerman answered that “‘isolate’ is definitely a definition…that we will propose for regulation” in addition to “distillate.”
- Peterson posted the existing definition in state law:
- “‘Hemp extract’ means 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.”
- Elgar was in favor of removing the proposed definition’s wording around what didn’t constitute hemp extract. Wise also had “a problem with the word ‘solvent’ in the first sentence.” Peterson had similar concerns: “we're creating gray areas” with the current exclusions. Tonani joined this line of thinking, contemplating whether it covered “hash dry ice.”
- Douglass tried to clear up that the wording was used in the “context of botanical extracts.” The initial sentence was meant to differentiate “an extract from a concentrate,” he said, while the following sentence aimed to “cover any type of extract, in any type of format" in “all physical states of an extract.” Peterson wanted to know "where is that cutoff” and Douglass told her it was "anything that uses a solvent…including CO2, including water.” Wise asked if there were “plans to include ‘isolate’, ‘concentrate’ as part of hemp in food, explicitly” and was told by Douglass that the recommendations from the task force should call for those terms to be “defined somewhere.”
- Tonani inquired whether they would define “‘isolate,’ ‘concentrate,’ everything, or did we just say ‘Hey, there's limits on how much of these you can put in a product based on the concentration, milligram concentration, of Class A or Class B, and leave it at that?” Beckerman’s opinion was that “we could certainly just say that these things are not allowed, we could say ‘a prohibition for a retail product, or for a process, or to include in their products.’ This regulation does not have anything to do…with anything that the FDA” regards as generally recognized as safe (GRAS). She didn’t believe there was support for “synthetically modified plant constituents in the extract,” and hoped if the substances weren’t excluded from the definition of ‘hemp extract’ they “need to be accounted for somewhere in the law.”
- Byers had members restate their concerns over the definition. Tonani summed it up as involving “the first paragraph and how much of that first paragraph is needed or should be substituted.” Peterson was certain that there could be other definitions in legislation beyond hemp extract, and Wise saw no reason the work group couldn’t recommend additional definitions or modify the one for ‘hemp extract’ already in law (audio - 9m).
- Beckerman and Elgar were in agreement on shortening the third sentence in the definition to read as excluding (i), (ii), and (iii) from the definition of hemp extract. Peterson noted the established definition for ‘hemp processor’ was also certain to need modification.
- After further discussion, work group members agreed to vote on a final version of the definition of ‘hemp extract’ at their next meeting on October 4th.
- The proposed definition stated:“Hemp extract means a complex, multicomponent mixture obtained after using a solvent to dissolve components of the biomass. Extracts may be in dry, liquid, or semisolid form. Hemp extracts are not the same as expressed juices or oils, or pure chemicals isolated from an herb, and do not include:
- Turning to the definition of Class A and Class B cannabinoids, Peterson explained how “many of the scientists that are part of the group spent many, many hours, days, months…looking at this and making it as tight as possible, so it actually was based on science that could be proven.” This was done “in response to the LCB legislation” which she characterized as “just putting that word out there and…writing law around a word that had not been defined.” Peterson restated that the work group was “first defining what gets you high, and then [Class] B is everything else.” They weren’t attempting to exclude either classification, they were “just saying these are the things that get you high that can be proven by structure and function” (audio - 4m).
- Class A cannabinoid means:“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:
- (1) Delta-10-THC and isomers;
- (2) Delta-9-THC and isomers;
- (3) Delta-8-THC and isomers;
- (4) Delta-7-THC and isomers;
- (5) Delta-6a-THC and isomers; and
- (6) Delta-10a-THC and isomers;
- (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;
- (A) Tetrahydrocannabinols – a single double-bond in the C ring:
- (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.”
- (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:
- Class B “means all cannabinoids that do not meet the form and function of Class A cannabinoids.”
- Tonani approved of the definition identifying “pretty much all of the compounds that…are currently being marketed that have the ability to get people high, or impair them, and I think that that's one of the things that needs to be addressed in order to move hemp into food.” Moreover, it addressed future compounds if “people get creative." Overall, she viewed the definition as doing “a pretty good job of being pretty inclusive and identifying…the things that maybe give hemp a…bad name as far as being impairing.”
- Beckerman also found this definition “grew on me” and she now felt “liberated from the conversation that I had with Brad that class A cannabinoids and class B cannabinoids are what need to be addressed here.” Between this classification and a definition for ‘synthetically modified plant constituents,’ she was confident legislation resulting from their recommendations “would effectively regulate out what is causing all of the public harm and the hemp industry concerns.” Barfield chimed in to state that other task force members “reassured me that some of the legislators like some of these definitions, so I'm definitely okay with moving these forward and avoiding things like ‘impairment’ and ‘intoxicating’” (audio - 3m).
- Elgar asked if the definitions would be added in statute or rule and how any new cannabinoids would be added. Peterson said the wording to define Class A “specifically has a process…for how that works” to include compounds at a later date (audio - 2m).
- Wise and Beckerman expressed satisfaction with the wording to the approval of Peterson (audio - 1m).
- Class A cannabinoid means:“a substance that meets the following structural and functional criteria:
- Byers wrapped up the work group presentation, asking if they wanted more input from task force members. Beckerman welcomed any additional suggestions that might refine definitions (audio - 1m).
- Tonani posed the question of whether the group was happy “with holding the definition of a ‘dietary supplement’ based on Washington state law?” Beckerman was “absolutely” on board with that if it matched the equivalent definition in the CFR (audio - 3m).
- Jim Makoso, Lucid Lab Group Director and Washington State Legislative Task Force on Social Equity in Cannabis (WA SECTF) Co-Chair, checked if Byers and WSDA staff had an “outline already for which we're gonna plug these final pieces of work into for the total report” due in December. He compared this with WA SECTF staff who were “scrambling now to plug in recommendations we've been doing for the last couple of years into a report” (audio - 6m).
- Byers reported that this task force and a separate Hemp Commission Task Force were on their way towards generating their legislatively mandated reports, summing up his sense that “we're not worried about…composing the whole rest of the report.”
- Peterson described how her work group had used a recommendation template from the Cannabis Science Task Force.
- Peterson started off with their proposed definition around “hemp extract,” derived from the AHPA “extract definition for dietary supplements.” She also indicated there were relevant definitions in a 2021 law, SB 5372, "Concerning hemp processor registration and a hemp extract certification" that “dealt specifically in regards to human ingestion.” The wording had been “suggested by Lucas” Barfield, Quality West Cannabis (QWC) Owner and task force member, she commented. Beckerman highlighted that “we're not defining a finished product here” and there would be additional definitions “for an in-process hemp extract and certainly a finished product” (audio - 3m).
- WA Hemp in Food Task Force facilitator Steven Byers outlined next steps for the task force whose members agreed to reconvene on Wednesday October 5th (audio - 13m).
- “The recommendations of this task force are due to the agency by the end of October,” Byers commented, forecasting that under the group’s tight schedule “we get done what we can get done and there might be other recommendations for you know, ongoing work, additional research, additional thinking and deciding.”
- Following discussion by task force members, the group agreed to meet again on Wednesday October 5th.
Information Set
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Announcement - v1 (Sep 23, 2022) [ Info ]
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Announcement - v2 (Sep 28, 2022) [ Info ]
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Announcement - v3 (Sep 29, 2022) [ Info ]
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Announcement - v4 (Sep 29, 2022) [ Info ]
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Agenda - v1 [ Info ]
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Agenda - v2 [ Info ]
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Chat Log - v1 (Sep 29, 2022) [ Info ]
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Chat Log - v2 (Sep 29, 2022) [ Info ]
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Complete Audio - Cannabis Observer
[ InfoSet ]
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Audio - Cannabis Observer - 00 - Complete (2h 19m 58s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 01 - Welcome - Steven Byers (2m 33s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 02 - Question - Recommendations - Joy Beckerman (1m 26s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 03 - Comment - Joy Beckerman (3m 42s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 04 - Question - Brad Douglass (3m 3s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 05 - Concentration and Safety Work Group - Recommendation 1 - Jessica Tonani (1m 15s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 13 - Concentration and Safety Work Group - Recommendation 2 - Jessica Tonani (1m 45s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 14 - Concentration and Safety Work Group - Recommendation 3 - Jessica Tonani (1m 27s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 16 - Concentration and Safety Work Group - Recommendation 3 - Jessica Tonani (1m 45s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 19 - Concentration and Safety Work Group - Recommendation 4 - Jessica Tonani (1m 50s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 21 - Concentration and Safety Work Group - Recommendation 4 - Jessica Tonani (1m 13s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 28 - Concentration and Safety Work Group - Recommendation 6 - Jessica Tonani (1m 22s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 33 - Concentration and Safety Work Group - Recommendations - Wrapping Up (2m 29s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 35 - Break (22s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 36 - Definitions Work Group - Recommendations (2m 18s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 37 - Definitions Work Group - Recommendation - Hemp Extract - Bonny Jo Peterson (3m 13s; Sep 29, 2022) [ Info ]
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Audio - Cannabis Observer - 50 - Next Steps - Steven Byers (13m 18s; Sep 29, 2022) [ Info ]
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WA Hemp in Food Task Force - Meeting - General Information
[ InfoSet ]
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Announcement - v1 (May 16, 2022) [ Info ]
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Announcement - v2 (May 18, 2022) [ Info ]
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Document Repository - WSDA (Sep 6, 2022) [ Info ]
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Legislative Report - v3 (Nov 30, 2022) [ Info ]
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Legislative Report - v4 (Jan 12, 2023) [ Info ]
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