Note: The opinions I express here should not be construed as medical or legal advice. Marijuana is classified by the federal government as a Schedule I drug. Protect your freedom and your health by consulting a lawyer and your doctor for legal and medical advice.

In response to the California Department of Public Health’s invitation to comment on proposed regulations on medical cannabis:

I welcome the State of California’s proposed regulations for the manufacturing of medical cannabis, which I believe will help protect the safety of individual consumers and communities. I offer here my opinions on these proposals.

Despite its federal status as a Schedule I drug, cannabis is used medicinally by millions of Americans. Although only a small handful of compounds produced by plants in the Cannabis genus have been characterized, this number continues to grow as evolving legislation opens doors to medical and scientific research. Many of these compounds are known to possess therapeutic potential, individually or in synergy with other compounds. In the absence of a comprehensive body of scientific literature on C. sativa and C. indica, patients and recommending providers have few tools to help them tailor cannabis-based therapeutics, largely relying on empiric observations and trial-and-error. Each strain has a unique portfolio of psychoactive and non-psychoactive compounds which affect individuals uniquely.

Safeguarding health consumers’ safety should be the primary goal of these proposed regulations. Protecting communities and preserving the environment are also of paramount importance. The proposed regulations offer many theoretical benefits. My critique stems from a concern that these regulations, whether intentionally or unintentionally, place the interests of larger growers over smaller growers. I fear the rise of the cannabis industry’s equivalent of “Big Tobacco.” The proposed regulations disproportionately burden smaller growers with financial and bureaucratic hurdles which I worry will render so-called “Cottage” operations non-viable. The proposed regulations would impose a higher fee-to-revenue ratio for “Cultivation Licenses” for Tier 1 operations, defined as those yielding less than $100,000 in annual revenues, compared to higher tier operations.

For instance, Section 8305 and Section 8313 (“Cannabis waste management”) do not discriminate between small and very small growers, and large operations which pose much greater threats to the environment and water supply.

Favoring larger growers over smaller growers poses a threat to medical cannabis’ genetic diversity by incentivizing growers to produce the most profitable strains, rather than supplying the market with a variety of strains to meet the diverse needs of patients. This is the case with conventional as well as organic produce.

I urge the State of California to consider creating a separate category for “micro-entities,” which I define here for the sake of argument as growers possessing no more than 6 plants. Regulations should also discriminate between micro-entities who manufacture medical cannabis for their personal consumption, and micro-entities who sell what they produce. The current definition of “commercial cannabis activity” as activities that include “cultivation, possession, manufacture, processing, storing, laboratory testing, labeling, transporting, distribution, or sale of medical cannabis or a medical cannabis product” is problematic because it does not make the aforementioned distinction. The rationale for imposing regulations on large growers to protect consumers, communities, and the environment does not apply equally to large and small growers. Micro-entities should be subject to regulations that do not disproportionately burden them and should be exempt from much of the administratively burdensome language of these proposals. Because micro-entities do not share the same financial incentives as large growers, I hope that making it easier for micro-entities to manufacture medical cannabis would promote the genetic diversity of medical cannabis.

I would also like to briefly comment on the language of a few other statements which caught my attention. Section 8401 describes a “Track-and-Trace” system that would allow the State of California to account for the production and dissemination of medical cannabis products. We should apply our experience with other industries to prevent State and private monopolies from hindering innovation. I use the example of Electronic Health Records because of my familiarity with the healthcare industry: stringent regulation on electronic medical record vendors has promoted the formation of monopolies to the detriment of innovators who would have otherwise worked to develop more functional and less expensive software. It is crucial that a State-sponsored Track-and-Trace system feature an open API which would facilitate the growth of an ecosystem of tools to help growers and manufacturers comply with these regulations.

I also advocate against a separate “Nursery License”, particularly for smaller growers, because it would impose further licensing hurdles for these growers.

Article 1, Section 8000, Subsection (f) states: “Commingling is prohibited in Section 8207 of these proposed regulations to retain the integrity and clear accountability of the product.” I strongly agree with this statement for the aforementioned reasons.

Subsection (t) defines “outdoor cultivation” as “a method of cultivation techniques that does not use light deprivation techniques. Outdoor growers who rely entirely on natural sunlight can utilize light deprivation to harvest up to 4 times annually. I find the definition of outdoor cultivation inaccurate and misleading. Outdoor cultivation could instead be defined by whether or not electrical energy is the primary light source for marijuana plants.

My final comments pertain to county regulations rather than state regulations, but I would like to express them here since state regulations supersede county regulations. Mendocino County imposes regulations on marijuana farms which also apply to vineyards, such as having restrooms in greenhouses, limits to the maximum incline grade leading to a greenhouse, and the construction of greenhouses. Again, safety of patients, cannabis industry workers, communities, and the environment is paramount. At the same time, It’s worth bearing in mind that the nature of a medical marijuana farm is much different than a vineyard. To consumers of medical cannabis, marijuana is medication. A vineyard is a recreational area and its product has no therapeutic indication accepted by the medical community. I again urge the writers of these regulations and California voters to consider a more nuanced definition of “commercial cannabis activity” than the current one.

Thank you for the opportunity to comment on these proposed medical cannabis manufacturing regulations.

Respectfully,

Omar Metwally, MD

 

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