On Friday, September 29, California’s three cannabis licensing agencies—the Department of Consumer Affairs’ Bureau of Cannabis Control, the Department of Food and Agriculture’s CalCannabis Licensing Division, and the Department of Public Health’s Manufactured Cannabis Safety Branch—released summaries of their responses to the public comments submitted for the draft medical cannabis regulations under MCRSA, which came out earlier this year.
Even though those draft regulations were subsequently withdrawn after the Medicinal and Adult-Use Regulatory and Safety Act (MAUCRSA) unified the state’s medical and adult-use licensing systems earlier this year, the comments submitted by the public will still help guide the agencies as they develop the emergency regulations under MAUCRSA, which are expected to be published in November 2017. Temporary licenses will still be issued starting on January 1, 2018.
A common response to public comments was that a particular requirement is mandated by statute, and thus the licensing agency does not have the authority to change that requirement. While the agencies have the ability to supplement and define the requirements included in the statutory requirements, where the statutory requirements are clear the agency will only have the authority to enforce, not interpret. Many other responses indicated that the agency is evaluating the requirement in question and may make modifications for the MAUCRSA regulations.
Some of the summarized comments and the agencies’ responses are reprinted below:
Department of Consumer Affairs – Bureau of Cannabis Control (“The Bureau”)
- The regulations should permit shared premises, including multiple businesses of same and different license types, as well as permit multilevel or vertical stacking of the designated premises. The Bureau is developing regulations related to colocation of licensees on premises.
- Security guards should be left as a business decision or local jurisdictional decision and only should be required for retailers. The Bureau is evaluating whether the security guard requirement should only be applicable to retailers.
- The Bureau should consider permitting additional modes of transportation other than vehicles over the roadway. Specifically, bicycles should be permitted provided they use a lock box that is compliant with the Bureau’s security regulations. Business and Professions Code section 26070 requires all vehicles transporting cannabis and cannabis products for hire shall be required to have a valid motor carrier permit. Due to the express language in the law, the Bureau is determining the range of vehicles that can be issued a motor carrier permit.
- Ten increments of manufactured edible samples for the homogeneity test, plus the primary samples and the duplicate samples, is excessive and an unreasonable burden. The Bureau should consider reducing the amount of sample mandated for testing. The Bureau is currently evaluating the requirements for homogeneity testing.
- The Bureau should not require an additional resealable exit packaging due to additional costs for the dispensary and patient. Business and Professions Code section 26070.1 requires cannabis and cannabis products be placed in an opaque bag before leaving a retailer. The Bureau does not have the authority to change the requirement for an opaque exit bag contained in the law; however, the law does not require a resealable exit bag. The Bureau is evaluating the use of recycled or customer-provided opaque packages.
- The regulations should permit free samples to be given to patients and employees as training tools. The Bureau is evaluating whether to allow samples and the possible methods by which samples could be provided.
California Department of Public Health – Manufactured Cannabis Safety Branch (“CDPH”)
- CDPH received a range of comments regarding the prohibition on certain products (§40300).
- Alcoholic beverages: Clarification was requested as to whether the prohibition would extend to a prohibition on tinctures. This prohibition is not intended to restrict the production of tinctures. CDPH will make clarifying changes to the text for the MAUCRSA regulations. Clarification was requested as to whether the prohibition was applicable to just infusion with THC or included CBD as well. CDPH will continue to review the issue. Requests were made to allow THC-infused alcoholic beverages. CDPH continues to have concerns regarding the combination of THC and alcohol, and we will continue to review the issue.
- Caffeine as an additive: Clarification was requested regarding the prohibition on caffeine as an additive. This prohibition is not intended to restrict the manufacture and cannabinoid infusion of products with naturally-occurring caffeine, such as coffee, tea, and chocolate. CDPH will make clarifying changes to the text for the MAUCRSA regulations. Requests were made to allow caffeine, perhaps a capped amount, to be added to products. CDPH will review the comments provided and remains committed to protecting public health.
- Potentially hazardous foods as products: A majority of commenters expressed concerns regarding the prohibition on the manufacture of any product considered a potentially hazardous food. The most common concerns cited included: That the prohibition would eliminate a large segment of the existing industry, Many manufacturers and patients would turn to the black market, Patient needs and desires for these products would not be met. On the other side, local jurisdictions, public health organizations, and the California Medical Association expressed support for the prohibition, due to the decreased risk of foodborne illnesses. CDPH continues to have concerns about product safety. Because cannabis is still considered an adulterant under federal laws, the same food safety laws and levels of oversight are not applicable to cannabis products. CDPH will continue to review the issue to ensure public health concerns are addressed.
- Potentially hazardous foods as ingredients: Clarification was requested as to whether this restriction would apply to ingredients used in manufacturing. The restriction on the use of potentially hazardous foods is not intended to apply to ingredients (such as milk, butter, eggs, or juice), as long as the final product does not need time temperature controls to maintain its quality and safety. CDPH will make clarifying changes to the text for the MAUCRSA regulations. Similarly, clarification was requested as to whether the prohibition on canned foods would prohibit the use of cans as a packaging option. The prohibition only intended to apply to low-acid canned products, the kind that pose a risk of botulism. CDPH will make clarifying changes to the text for the MAUCRSA regulations.
- Shared Facilities. A request to allow for shared facilities or community kitchens (a shared facility is one in which multiple licensees share the same premises and equipment) was another common theme. Commenters expressed numerous potential benefits to shared facilities. However, because the definition of “premises” added to MAUCRSA limits a premises to only one licensee, CDPH does not believe it has the authority to permit shared facilities and that a statutory change would be necessary in order to do so.
- THC Product Symbol. Comments on the THC product symbol recommended changes to be made to the symbol (changes to the color, requests for a pictorial element such as a cannabis leaf). CDPH will be revisiting the specifications of the symbol.
- License Type: Ethanol. Based upon comments received, CDPH will further clarify the use of ethanol in manufacturing. Ethanol extraction, if used in a manner that creates a risk of explosion or fire, such as high heat or pressure, would be classified as a Type 7 license. Other uses of ethanol, such as tinctures or “winterization” to refine extracts, would be considered Type 6.
California Department of Food and Agriculture – CalCannabis Licensing Division (“CDFA” or “CalCannabis”)
- Indoor, Outdoor and Mixed-light cultivation: The Department received significant input on the proposed definition of ‘mixed-light,’ as well as the proposed definitions for ‘outdoor’ and ‘indoor’ cultivation. Stakeholders suggested that light deprivation practices should be permitted in the outdoor category. Recommendations were also made to reduce the watts per square foot threshold and clearly differentiate the use of supplemental light preventing plants from flowering from the use of high intensity lighting supporting flower production. Stakeholders suggested a separate tier license for light deprivation. It is clear to the Department that the cultivation category definitions will require further refinement.
- Waiver of Sovereign Immunity: The Department received a number of comments on the waiver of sovereign immunity for federally-recognized tribes to participate in the licensed marketplace. Commenters questioned whether the Department has the authority to require an immunity waiver from sovereign nations and that the proposed regulation potentially infringes on tribal sovereignty. Recommendations included a removal of the proposed regulation in the interim. The Department, in collaboration with the Department of Consumer Affairs and Department of Public Health, will continue to work with stakeholders on this issue.
- Commingling: The Department received comments from a number of concerned stakeholders regarding the proposed prohibition on commingling. Comments ranged from requesting clarification to asserting the regulation is prohibitive of small business practices. Many requested that commingling be allowed because the robust track-and-trace system should be able to link commingled flowers to the associated cultivation sites. The Department will continue to work with stakeholders on this issue.
- Cannabis Waste Disposal: The Department received substantial feedback that the proposed cannabis waste disposal requirements were overly burdensome, would lead to excess waste being contributed to landfills, and that the five day holding period was too long and could lead to pest infestations. Commenters requested clarification on the allowance of composting onsite. There were also suggestions to introduce a new license type that could process cannabis waste off-site. Note, MAUCRSA exempts mature plant stalks from the definition of cannabis. This will be taken into consideration as the composting and waste disposal requirements are improved.
- Generator Prohibition: The Department received input that the proposed prohibition of generators would be problematic for rural and off-grid cultivators. Commenters made recommendations to allow generators approved or permitted by other agencies and to include a phase-in approach for the regulation. Clarification about the definition of generator was also requested. The Department will continue to work with stakeholders to develop regulations that protect the environment while allowing existing operators to enter the regulated market.
- 42% Renewable Energy Source: The Department received significant feedback on the proposed requirement to use 42% renewable energy sources for indoor license types. Commenters favored both reducing and increasing the percentage. It was recommended that this requirement be phased-in and also apply to mixed-light license types. Clarification about how this section would be implemented was requested. The Department is considering changes in renewable energy requirements to better align with current state energy goals using a phased-in approach and will revisit the renewable energy source requirement and provide further specificity regarding implementation for this requirement.
You can read the agencies’ full responses to the comments here:
Be sure to visit the California Cannabis Portal at www.cannabis.ca.gov for more information and updates.
The above information is provided as a public service. It is not intended as legal advice.
For answers to your legal questions or legal assistance, please contact the Law Offices of Omar Figueroa at (707) 829-0215 to schedule a confidential legal consultation.