WSDA - Webinar - Marijuana Infused Edibles
(October 27, 2020)

Here are some observations from the Tuesday October 27th Washington State Department of Agriculture (WSDA) Marijuana Infused Edibles (MIE) stakeholder webinar.

My top 3 takeaways:

• Webinar participants introduced themselves during the first meeting hosted by the Department for MIE stakeholders in several years.
  • In accordance with HB 1462, a 2017 law, WSDA proposed and then adopted a rule change in February 2018 which took effect in April 2018 whereby the Department assumed “regulatory authority to license and regulate makers of food products that contain marijuana...Since implementation of Washington's recreational marijuana law in 2012, the Washington State Liquor and Cannabis Board (WSLCB) had been solely responsible for regulating processors making marijuana-infused edibles, or MIEs. Now WSDA will share that responsibility with the WSLCB.”
  • Introductions began with WSDA staff present (audio - 12m):
    • Steve Fuller, Assistant Director for Food Safety and Consumer Services (audio - 5m)
    • Kelly McLain, Policy Advisor to the Director
    • David Smith, Food Safety Program Manager (audio - 3m)
    • Luisa Castro, Policy and Performance Analyst (audio - 1m)
    • Trecia Ehrlich, Hemp Program Manager
    • David Erho, Food Safety Compliance Specialist
    • Jessica Ogden
    • Jeff Freshley, Food Safety Program Specialist
    • Gina Rich
    • Roger Smith, Food Safety Program Specialist
    • James Starr, Food Safety Program Specialist
    • Rebecca Stephany, Food Safety Compliance Specialist
  • Representatives of other state agencies:
    • Ryan Black, Washington State Department of Health (DOH) Deputy Director for Policy and Legislative Relations
    • Joe Graham, DOH Food Safety Program Supervisor
    • Susan Harrell, WSLCB Licensing Program Specialist, Label Approval
    • Kathy Hoffman, WSLCB Policy and Rules Manager
    • Nicola Reid, WSLCB Compliance and Adjudications Manager
  • Industry stakeholders and observers:
    • David Brown, Central Business District Staff Attorney
    • Reggie Brulotte, Brulotte Farms, Inc.
    • Brooke Davies, Washington CannaBusiness Association (WACA) Deputy Director
    • Brad Douglass, The Werc Shop Vice President of Intellectual Property & Regulatory Affairs
    • Gregory Foster, Cannabis Observer
    • Maurice Gordon, Emerald Mountain Operations Director
    • Marco Hoffman, Evergreen Herbal CEO
    • Edward Lafferty, Green Revolution Co-Founder and Chairman of the Board
    • Jim Makoso, Lucid Lab Group Director; Flowe Technology CEO
    • Katie Mitchell, Katie Baked Goods Founder + Confectioner
    • Jenn Nelson, botanicaSeattle
    • Crystal Oliver, Washington SunGrowers Industry Association (WSIA) Executive Director
    • Taylor Rausch, Green Labs
    • Gena Reich
    • James Shults, Wildflower Brands Quality and Compliance Manager
    • Jessica Tonani, VerdaBio CEO
    • Micaela Wakefield, Double Delicious Operations Manager
    • Rachael Weygandt, Evergreen Herbal Compliance Manager & Product Coordinator
    • Cajsha White

• WSDA staff presented and answered questions about Food Safety Program operations, allowance of dietary ingredients, a new licensing and inspection web application, and expansion of MIE product scope.
  • Food Safety Program Update (audio - 11m).
    • Smith said the MIE processor endorsement was among “upside of 300 ag endorsements” offered by WSDA and had been acquired by 74 licensees. 36 staffers for the Food Safety Program were mostly concerned with “food processors and warehouses,” he told the group. Smith stated that food processing was a “pretty stable manufacturing base here in the state,” and WSDA performed “somewhere around 2,000 inspections a year.” MIE applications had an “average processing time [of] 54 days” and staff processed “150 amendments” to MIE endorsements from September 2019 to September 2020, taking two weeks on average.
    • While staff had “adapted to the realities” of the COVID-19 outbreak, Smith explained they had “stepped away from routine work” to focus on complaints and risks. MIE facilities were seen as “low risk” leading to a similarly low prioritization for inspections. Smith noted that two positions “we were in the process of filling” had to be “put on hold” due to WSDA budget cuts related to the pandemic. They’d also lost a member of their “admin team.”
    • Smith noted employees had “taken on different ways to review amendments, to approve amendments” which wasn’t “unusual” for the program. However, the Department had chosen to identify inspectors with MIE expertise to “help centralize” approval of endorsements and amendments. Smith expected a “core group of three” Technical Review Specialists would increase “accuracy” as well as “consistency” and “communication,” “making decisions once” and then providing “them back out to industry.” Freshley, Smith, and Stephany would devote about 10% of their work week “towards MIE.” He admitted “that’s not much” but expected that level of commitment to continue for “the next year or so.”
  • FoodPro Licensing System (audio - 12m). Smith and Erho reviewed a new web-based portal for licensing application renewals, amendments, and payments based on the Intact Platform. They expected the system would save agency staff time, be more “transparent for all of us,” and offer “quicker customer service.” Erho anticipated that the system would be available in “maybe a couple months” to provide an interface for licensees to track their MIE endorsement applications, amendments, history of inspections, and program staff notes. Erho hoped the system would do away with paper copies of inspections and help avoid “things getting lost” (audio - 2m).
    • Nelson wanted a better idea of when the FoodPro portal would be available, which Erho called a “million dollar question” (audio - 1m).
  • Dietary Ingredients (audio - 3m). As of January 1, 2021, WSDA would begin accepting “amendments and applications that have dietary ingredients.” Smith stated ‘dietary ingredients’ included “a vitamin, mineral, herb, amino acid, or enzyme that’s meant to increase a daily intake.” He explained that those seeking applications or amendments would “have to do the legwork of determining acceptability for food use. He felt the U.S. Food and Drug Administration (FDA) Food Ingredient Packaging Inventory and the U.S. National Institute of Health (NIH) Dietary Supplement Label Database were “the gold standard for...dietary ingredient safety.” Smith said similar ingredients could be allowable and “if there’s peer-reviewed scientific research we will consider that as evidence.” He added that such ingredients must “still be low risk and the dietary ingredients cannot be a finished product.” Smith concluded by commenting that further guidance would become available online “in December.”
    • Makoso asked what would constitute “a finished product” (audio - 1m).
    • Weygandt wanted to know more about what was considered acceptable evidence for food safety and who at WSDA would be reviewing it (audio - 1m). She also asked about Generally Recognized as Safe (GRAS) ingredients (audio - 1m).
    • Marco Hoffman inquired about using “hemp or [cannabidiol] CBD as a food additive ingredient” which Smith answered in the following segment (audio - 1m).
  • Hemp and CBD (audio - 1m). Smith said WSDA was “still not allowing hemp in manufactured food” outside of “long standing” allowances for “hemp seed, the protein powder, and pressed oil.” He spoke to the FDA’s work defining federal rules around use of hemp in food, alleging that the agency had “quite honestly come up short on the science” and was “looking” for input.
    • Weygandt mentioned other states’ allowance for CBD in food and asked if WSDA could stomach a similar policy (audio - 2m).
    • During a recent engagement with a cannabis trade group, WSLCB Director Rick Garza indicated his agency was conducting a policy review about the possibility of permitting 502 retailers to sell CBD products.
  • Product Scope (audio - 1m). Smith talked about the “limited, low risk” products already permitted, including “baked goods, candies, some beverages, dry mixes, jams, [and] jellies.” He acknowledged requests from industry to expand the scope of MIE product types and called for discussion.
    • Marco Hoffman inquired about nutraceuticals (audio - 4m) as well as kombucha (audio - 2m).
    • Wakefield asked about several other product types including alcohol (audio - <1m).
    • Weygandt offered her perspective that “aside from kombucha...I don’t believe that we have a lot of barriers getting certain product types to market.” Ingredients were the obstacle most frequently encountered, and she wondered whether “we’re still going to be restricted to using that database that the FDA provided” for “food ingredients.” Weygandt said WSDA wouldn’t initially consider isomalt as an acceptable ingredient as it wasn’t in the aforementioned database - until Weygandt showed that a Jolly Rancher product in the “mainstream market” included it. Smith promised to get back to Weygandt after speaking to staff about “how we’ve been approaching that” (audio - 4m).
    • Davies and Brown started a conversation about expansion of product scope to include pasteurized products (audio - 5m).
      • Davies mentioned HB 2726, unsuccessful 2020 legislation that would have permitted pasteurized items, and said she knew several WACA members were interested in that expansion of product scope although the trade association had not formulated a position.
      • Brown said that California, Colorado, and Oregon already permitted such products leaving Washington processors at a “competitive disadvantage.” He also noted that carbonation or citric acids in drinks could actually “denature” the CBD or tetrahydrocannabinol (THC) in them and “you might find that you no longer have ten milligrams of THC in it after it’s been on the shelf a little while.”
      • Smith agreed that the Department had tried to limit the market to low risk items and asserted that pasteurization was “always a high-risk process.”
      • Fuller tried to re-frame the product scope discussion by describing how food safety authority was shared with WSLCB, and WSDA would have to work with them to implement changes in "an arduous administrative process.” Expansion of product scope had public health and “other regulatory implications” such as inspection of retailer refrigeration systems in coordination with local health jurisdictions or DOH. While WSDA would “love to incrementally move the way that we regulate” MIE towards “the way that we regulate other food products,” they had to be deliberate and include DOH and WSLCB in the process. WSDA’s aim was “the most benefit to the largest segment of the industry” (audio - 4m).
      • McLain offered another question on the classification of pasteurization (audio - 2m).
        • Representing WSDA’s position of “other” on HB 2726, McLain testified that the bill “include[d] adding foods that are high risk, including acidified foods, dairy, frozen foods and desserts, and low-acid canned foods” necessitating “a level of detailed review and expertise that does not currently lie within the Department of Agriculture.” The Department would need more staff to “review complex applications and determine if intended processes meet legal and public health requirements” which created “significant fiscal impacts,” she remarked. McLain instead suggested a budget proviso directing WSDA to work with stakeholders to identify “the lowest risk of those high risk foods as a first stepping stone into the high risk food space” (audio - 2m, video).

• The meeting concluded with a final round of questions and an agreement to create a new MIE product scope work group.
  • McLain asked about meeting frequency going forward (audio - 1m). 
  • Smith gauged interest in creating a separate industry work group focused on expansion of product scope (audio - 1m).
  • Weygandt suggested WSDA participate in WSLCB’s label approval process. She believed this could reduce the need to question label features added following WSDA guidance. Smith was noncommittal before consultation with the label approval team (audio - 2m).
    • WSLCB Compliance and Adjudications Manager Nicola Reid and Label Approval Specialist Susan Harrell were present on the call, but did not offer comment on Weygandt’s idea.
  • Castro thanked participants for the “clarity” they’d provided throughout the event. She said meeting notes and materials would be shared online and asked for anyone who wanted to join the product scope work group or receive MIE updates from the Department to email program staff (audio - 3m).