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Listening Session #5 – Cultivation and Manufacturing Practices Part 1
Following formalities, Dominique Mendiola gave an overview of DOR’s statutory requirements under Title 44 regarding cultivation and manufacturing. Under the Department’s reading of the statute, their authority extends to
- Requirements and restrictions on types of products permitted
- Serving amounts and packaging (including the definition of a ‘microdose’)
- Health and safety standards
- Sanitary requirements
- Occupational health standards
- Recall plans and preventative controls
- Waste, disposal, & storage standards
- Sustainability
- Transportation of natural medicine
- Inventory, tracking, & manifest requirements
- Warning labels
- Production limits
Ms. Mendiola also pointed out statutory restrictions on natural medicine cultivation and manufacturing businesses. First, natural medicine products may not mimic a trademarked food product. Second, a cultivation or manufacturing facility may not be located within 1000 feet of a child care center, preschool, K-12 school, or residential child care facility.
15 members of the public spoke in the 45 minutes of open discussion on the following questions:
- What traditional or historical cultivation practices can serve as a foundation for regulatory guardrails or requirements?
- What is the average weight of a single flush of psilocybin?
- What types of products should be permitted (or prohibited) within the regulated space?
- Do certain product types pose increased safety risks that need to be considered or addressed through regulations?
- What are the emerging product types and should those emerging products be subject to more stringent or additional requirements in order to be utilized in an administration session?
- If the Department has the authority to limit the number of cultivation and manufacturing licenses issued, should it?
Several members felt that average flush size was not a useful indicator to track, given the variation in potency and mushroom size by strain. At least two members encouraged DOR to limit natural medicine products to their natural form of whole or ground fruiting bodies, citing the fact that other alkaloids play an important role.
Several members of the public also discussed products that currently exist in the gray market, most commonly chocolate bars. Other products mentioned were teas, gummies, extracts, tinctures, capsules, and pressed tablets.
The issue of natural medicine’s susceptibility to degradation by water was mentioned multiple times in relation to manufacturing and packaging processes as well as regarding the need to test potency in the final forms of products to accurately account for degradation that may have occurred during manufacturing.
Other concerns raised by the community were the need for guardrails protecting smaller cultivators, the safety profile of manure as a cultivation substrate, drying methods, and the need for a transportation system which allows law enforcement to easily recognize a legal transfer.
At the close of the meeting, DOR indicated that the next round of Listening Sessions will begin in November and sessions will increase to 1.5-2 hours. In addition to building on some of the previous round, the next round will cover data collection, inventory tracking, package and labeling, businesses and licensing consideration