The following public comment on the proposed California Medical Cannabis Regulations for Manufacturing has been submitted by Canna Legal, a division of Beck Law P.C., to the California Department of Public Health, Office of Manufactured Cannabis Safety.
On behalf of our clients, I respectfully submit the following public comment on the proposed medical cannabis regulations for manufacturing. These issues will profoundly impact the cannabis industry; therefore, we have provided recommendations for your consideration.
Before addressing specific sections of the proposed medical cannabis regulations, I would like to note that the proposed regulations do not properly define or address post-processing manufacturing. Cannabis Post-processing is also known as refinement, distillation or Winterization. In the comment below regarding Section 40100 and the definition of “nonvolatile solvent” and “volatile solvent,” post-processing is described in greater detail.
The extraction process produces a “raw” or “crude” cannabis concentrate, which contains unwanted lipids that must be removed before the concentrate is ready for consumption or for use in other products. Even if the extraction method utilized leaves fewer lipids in the raw cannabis concentrate, post-processing is used to further refine the oil. For instance, post-processing can isolate terpenes or produce a desired potency. While some extractors also post-process cannabis concentrate, other manufacturers purchase raw cannabis concentrate and refine it into cannabis oil. The nature of post-processing requires a certain set of skills that are not necessary for extraction due to the mechanized nature of the extraction process. At a minimum, the Office of Manufactured Cannabis Safety (OMCS) should define post-processing. Ideally, the OMCS will also incorporate post-processing throughout the proposed medical cannabis regulations.
Cannabis Regulations Section 40100
The proposed regulations define “nonvolatile solvent” as “any solvent used in the extraction process that is not a volatile solvent. For purposes of this division, a nonvolatile solvent includes carbon dioxide used for extraction.”
The definition for “volatile solvent” means any “solvent that is or produces a flammable gas or vapor that, when present in the air in sufficient quantities, will create explosive or ignitable mixtures. Examples of volatile solvents include but are not limited to, butane, hexane, propane, and ethanol.”
Issue: The definitions of “nonvolatile solvent” and “volatile solvent” will severely impact the cannabis industry. Classifying ethanol as a volatile solvent will cripple medical cannabis manufacturers, and it will effectively make the Type 6 license useless.
Suggested Changes: Define “nonvolatile solvent” and “volatile solvent” based on the flash point of the solvent, and specifically permit ethanol as a nonvolatile solvent allowable under a Type 6 manufacturer license.
Reasoning to Support Suggested Changes: The OMCS should take a more nuanced approach in the definition and regulation of “nonvolatile” and “volatile” solvents. The definition of “nonvolatile” should be based on the flash point of the solvent, which would better align with standards from National Fire Protection Association (NFPA) and the Occupational Safety and Health Administration (OSHA) as well as CAL-OSHA. This sort of definition would provide important clarity for manufactures, state inspectors as well as local fire and safety officers.
- Legal Basis for Changing the Definition of “Nonvolatile Solvent”
In September 2016, Governor Brown signed AB 2679, which amended Section 11362.775 of the Health and Safety Code to provide guidelines for collective or cooperatives that manufacture medical cannabis products. Rather than create a new standard for fire safety regulations, AB 2679 allows for the use solvents that are “generally recognized as safe pursuant to the federal Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).” The OMCS should adopt a similar definition and use for solvents available to Type 6 nonvolatile manufacturing. The simplest way to achieve this, is to define “nonvolatile solvent” to include ethanol, because ethanol is generally recognized as safe according to federal guidelines and food grade ethanol is used in many forms of processed foods in which it is necessary to remove lipids from oils.
A definition that contemplates the flash point of the solvent would provide much needed clarity for licensees, inspectors and local emergency service providers. This has proven to be true in Colorado. Under the Colorado Revised Statues Section 18-18-406.6 defines “inherently hazardous substance” as “any liquid chemical, compressed gas, or commercial product that has a flash point at or lower than thirty-eight degrees Celsius or 100 degrees Fahrenheit, including butane, propane, and diethyl ether and excluding all forms of alcohol and ethanol.” Colorado’s definition of hazardous substance provides much more clarity for operators, inspectors and local emergency services providers. Importantly, Colorado’s definition allows for the use of ethanol, which is an important solvent for medical cannabis manufacturing.
- Impact on Industry
Defining ethanol as a “nonvolatile solvent” is critical to cannabis manufactures, because ethanol is the most effective and efficient solvent. Without ethanol, the Type 6 nonvolatile license type will become ineffective, because post-processing requires the use of some potentially flammable solvent to remove lipids from the concentrated oil.
During the extraction process, ethanol remains a liquid, it does not have added heat, and the process is completed in a closed loop system. In post-processing or refinement phase (which is commonly referred to Winterization), ethanol is used to remove lipids from the oil. Winterization involves taking the raw cannabis concentrated oil and mixing it with 95% pure food grade ethanol until it is homogenized. The mixture is then then covered and placed in a freezer and cooled to below freezing (at least 30 degrees Fahrenheit). After the concentrate has been cooled to the required temperature, it is filtered through an apparatus called a Buchner funnel. This step uses vacuum to assist in pulling the solution through a laboratory filter paper, which removes the unwanted lipids and fats. Finally, the solution containing alcohol and cannabinoids is placed in a piece of UL list equipment called a rotary evaporator or rotovap. The rotovap uses a heated water bath, a vacuum pump, and a chiller to reclaim the ethanol through evaporation – essentially a vacuum distillation. This is also a contained closed loop system. After the entire processes is completed, the reclaimed ethanol is then put back into a sealed container for further use.
Without ethanol, the Type 6 license type becomes less important, because even if a cannabis manufacture utilizes compressed carbon dioxide for extraction, they also use ethanol for post-processing concentrates. This is because CO2 extraction leaves more lipids in the concentrated oil than any other type of extraction. Therefore, almost all CO2 extractors must use the Winterization process to distill their cannabis concentrates for use in other products and for consumption. Essentially, as defined, the Type 6 license will be a default Type N or P, because manufacturers will not be able to post-process or refine raw concentrated oil without a solvent like ethanol. This will require most manufactures that produce concentrated cannabis to obtain a Type 7 license type, even though the activities are more aligned with the Type 6 license.
- Existing Controls for Ethanol
Because ethanol is commonly used in a wide variety of manufacturing, fire and safety regulators, inspectors and responders are well equipped with the tools they need to allow for ethanol use in medical cannabis manufacturing. Contrasted to the use of more flammable volatile solvents like hexane and butane, the use of ethanol, if properly stored and handled, can be controlled to a high degree of certainty and safety. For stability, ethanol can be stored in tightly closed containers in a cool, dry, well-ventilated area, in areas kept at 55-100 degrees Fahrenheit. Measures like these can easily be managed and inspected by state and local officials. OSHA has established procedures and protocols for employees’ use of and storage of ethanol.
The common use of ethanol for manufacturing and the ability to control safety risks, distinguishes ethanol from other more flammable solvents. Both Sonoma County and the City of Santa Rosa allow cannabis operators to extract and post-process cannabis with ethanol as nonvolatile manufacturers. Through the existing building and fire codes, the City of Santa Rosa and Sonoma County can require a cannabis manufacturing facility to be constructed and operate with the use of ethanol on site in a manner is safe for employees, the community and the environment. This is a logical and practical approach for local jurisdictions, as it can be for the state.
Cannabis Regulations Recommendation: Change the definitions to the following:
“Nonvolatile solvent” means “any solvent used in the extraction process and any post-process that is not a volatile solvent. For purposes of this division, a nonvolatile solvent includes carbon dioxide and ethanol.”
“Volatile solvent” means any “solvent that is or produces a flammable gas or vapor, that has a flash point at or lower than thirty-eight degrees Celsius or 100 degrees Fahrenheit, including butane, propane, and diethyl ether and excluding all forms of alcohol and ethanol.”
Cannabis Regulations Section 40175. License Constraints.
Issue: Prohibiting sublets will burden the cannabis industry.
Suggested Changes: Allow sublets similar to the CDFA allowance for multi-tenant cultivation in Section 8206.
Reasoning to Support Suggested Changes: The cost of building out a facility for manufacturing is substantial. Allowing for subtenants would help offset some of the most costly systems, including ventilation, fire suppression and HVAC. In Section 8206 of the proposed cultivation regulations, “Multiple cultivation licenses and license types may be located on the same property, as established by an assessor’s parcel number, if each licensed premises has a unique entrance and immovable physical barriers between uniquely licensed premises.” With a similar allowance, OMCS inspectors would be able to evaluate and inspect uniquely licensed premises within the same facility.
Cannabis Regulations Section 40300. Prohibited Products.
Issue: Manufacturers should be able to produce edible products that require storage at temperatures at 35 to 42 degrees Fahrenheit.
Suggested Changes: Allow cannabis products that must be held at or below 41 degrees Fahrenheit, so long as the manufacturer follows other existing food safety requirements.
Reasoning to Support Suggested Changes: In the proposed regulations from the Bureau of Marijuana Control (BMC), distributors, transporters, dispensaries must all have facilities able to store edible cannabis products at 35 to 42 degrees Fahrenheit. (See Sections 5090, 5132, and 5214). If all the various chains of custody of cannabis products must have facilities to allow for storage of cannabis products below 41 degrees Fahrenheit, then the OMCS should allow for production of edible products that must be stored at 35 to 42 degrees Fahrenheit. Manufactures should be allowed to produce such products, if they otherwise follow food safety guidelines and they include expiration dates on the products.
Section 40305. Edible Products – Serving Size.
Issue: The proposed levels of maximum THC per serving and per package are far too low for many medical patients.
Suggested Changes: Allow cannabis products that contain higher amounts of THC per serving and per package so long as the products are clearly labeled.
Reasoning to Support Suggested Changes: While the proposed limitations for serving size may be prudent for a recreational cannabis market, it is of serious concern for medical patients who may need to mediate at higher levels than allowed as proposed. Particularly for patients with chronic pain or more serious conditions, consuming edible products with higher amounts of THC is necessary for their treatment. The OMCS should not restrict the dosage or levels of THC in medical cannabis products. However, products with high levels of THC should be required to have specific labels to distinguish the product.
Thank you for your consideration of these comments. Please feel free to contact my office if you have any questions related to this submission.