Public Comment on the DEA Proposed Rules for the Cultivation of Marijuana for Research Purposes
Jun 1, 2020
The United States Drug Enforcement Administration (DEA) recently accepted public comments on proposed controls to enhance the cultivation of “marihuana” for research purposes in the United States. These rules are purportedly designed to “enhance and improve research with marihuana and facilitate research that could result in the development of marihuana-based medicines approved by the Food and Drug Administration (FDA),” a request voiced by researchers for decades. The public comment period represented an important and timely opportunity to provide DEA with data and materials to inform its determination of how cannabis cultivation and disbursement for research should be regulated.
On May 21, 2020, Vicente Sederberg LLP submitted its public comment via the regulations.gov docket. VS also worked with Minorities for Medical Marijuana and the Minority Cannabis Business Association to submit comments for multiple minority groups advocating for a more equitable industry through the inclusion of social equity and social justice provisions.
Vicente Sederberg LLP's Public Comment
For the reasons set forth below, we respectfully urge DEA to allow participation and collaboration with state-licensed operators and state regulators who have been operating in and overseeing regulated cannabis markets for years. A similar position is supported by US federal agencies, as discussed further below in this comment.
We propose DEA allow these parties to participate in one of two ways: (1) immediately allow state-licensed cannabis manufacturers and dispensaries to supply research stock to DEA-registered researchers under 21 U.S.C. § 822(d); or (2) under 21 U.S.C. § 823(a), establish a regulatory and licensing framework for cannabis research manufacturers similar to that established by the United States Department of Agriculture (“USDA”) for the hemp industry. Taking one of these actions will enable DEA to supply registered researchers with larger quantities of better qualities of research cannabis, while simultaneously reducing substance abuse and the presence of illicit drug markets throughout the US.
We set forth the reasoning for the above suggestions in three parts below: (I) facilitating research to develop US Food and Drug Administration (“FDA”)-approved medical cannabis products; (II) encouraging DEA outreach and collaboration with local communities throughout the US; and (III) encouraging DEA to use its statutory authority to implement a federal cannabis research program allowing participation by state-licensed operators and state regulatory bodies.
Facilitate Research to Develop FDA-Approved Medical Cannabis Products
DEA should allow state-licensed operators to manufacture and sell research stock to DEA and DEA registrants because these individuals are most qualified to produce research stock that will best facilitate the development of FDA-approved medical cannabis products. State regulators should also be permitted to oversee this process, as they are the most experienced in ensuring adherence to time-tested operational best practices, testing standards, and security requirements.
We applaud DEA for its efforts to promote the effective research and development of cannabis products for medical and scientific purposes. To truly “enhance and improve research with marihuana and facilitate research that could result in the development of marihuana-based medicines approved by the [FDA],” as DEA believes these rules will accomplish, we must ensure that: (1) research stock is manufactured through industry best practices; (2) research stock is thoroughly tested in independent, accredited laboratories; and (3) time-tested security measures are implemented to prevent criminal activity and diversion into illicit markets.
Industry Best Practices
No manufacturers or regulators are more experienced in cannabis than those who have been operating and regulating the industry in various state-regulated markets for years. State operators have perfected best practices for cultivation, manufacturing, and research of the cannabis plant over decades of trial and error in every climate and environment imaginable, and in all cases under stringent regulatory oversight.
These regulators and state-licensed operators are thought and action leaders in policy, science, research, and public safety. By incorporating these existing supply chains into those used for federal cannabis research, seasoned operators and expert regulators will utilize industry-leading technical expertise and wide-ranging insights into various forms of policy governing cannabis control to implement the best federal system possible. These parties have witnessed the evolution of cannabis regulation and are ready and willing to support DEA in its mission here today. DEA should collaborate with state regulatory bodies and state operators to promulgate proposed rules that promote the utilization of industry best practices and allow these experts to implement those practices in operations.
Analytical Testing Standards
Regarding analytical testing, most state-sanctioned programs require that state-licensed, independent, accredited laboratories conduct scientifically sound quality assurance testing of all cannabis products before they reach the market, including, at a minimum, mandated adherence to rigorous heavy metal and contaminant thresholds. Importantly, this testing provides a layer of protection for American consumers, however testing standards are often inconsistent from state to state. DEA should work with local regulators and state operators to ensure that minimum standards for analytical testing are established. DEA should also require that any cannabis used for research and development under the federal program undergoes similar testing. This will ensure that any products which may be eventually approved by the FDA are formulated using raw materials that passed all quality assurance and safety testing. Contaminants, such as pesticides, can be severely injurious to American consumers and unnaturally alter the outcomes of research studies. State legal operators have been navigating strict testing requirements put in place by state regulators for years and will be able to immediately provide safe and effective cannabis for research purposes. DEA should take this opportunity to gain invaluable insight from these individuals to avoid pitfalls that departments of public health and other agencies across the country have already faced and conquered by implementing strict analytical testing standards and requirements.
State-regulated markets have extensive security measures in place that have been proven effective throughout years of cannabis manufacturing and dispensing operations. At the time of application, state-licensed cannabis operators are thoroughly vetted by state regulators through extensive disclosure requirements. This process includes thorough criminal disclosures, background checks, fingerprinting, and rigorous security clearances, all of which must be completed prior to licensure and annually upon renewal in most cases. This process is much more onerous than that which DEA puts forth in its proposed rules, rightfully so. DEA does not have the capacity to vet these operators in the same detailed and consistent manner that state regulators do because they are vetting a smaller group of operators, whereas DEA will be registering applicants nationwide. By putting faith in state regulators’ vetting and monitoring efforts which have proven to be effective, DEA will simultaneously reduce the administrative burden it experiences in licensing and ensure the individuals operating in this space come from impeccable backgrounds.
These state-regulated markets also consistently mandate compliance with strict security requirements during operation, including but not limited to surveillance systems, alarm monitoring systems, security guard presence on-site, and 24-hour off-site monitoring. Also important is the mandated use of established seed-to-sale tracking systems, which can alert regulators to the location and status of cannabis plants at any point and time throughout the supply chain. Systems such as MJ Freeway, METRC, BioTrackTHC, and others are regularly implemented across various state markets to ensure that regulated cannabis is not diverted into illicit markets or transported across state lines. This type of tracking is not contemplated under DEA’s proposed rules, but, if implemented, would likely result in (1) a safer and more secure research program for all, and (2) decreased administration burden and costs for DEA. This reason, as well as the others listed above, further supports the position that state-licensed operators and state regulators be afforded a seat at the table when discussing the federal cannabis research program. These individuals offer insights in planning stages that are invaluable to the development of a successful program. We also urge DEA to consider allowing these parties to participate, whether operationally or through local governance, in those programs once in existence. No registrants will be more experienced in complying with strict security measures than those who have already been doing so for years.
To best facilitate research that could result in the development of FDA-approved cannabis-based medicines, and to ensure public health and safety surrounding cannabis production, DEA-registered researchers should be allowed to formulate and research products produced by the best in the industry, under rigorous testing standards, and governed by strict security requirements.
Encouraging DEA Outreach and Collaboration with Local Communities Across the US
DEA should allow state-licensed operators to participate in the bulk manufacturing and sale of research cannabis because it would promote DEA’s commitment to community outreach, while reducing substance abuse in our local communities through education and by providing employment in regulated markets.
We know DEA values community outreach as a critical component of its primary law enforcement mission to prevent the sales and use of illicit drugs. DEA has worked with community coalitions and state and local governments all over the country to increase drug use prevention education. In order to reach and educate every American citizen regarding the dangers of drug abuse, DEA must collaborate with the residents of these local communities across the US. By collaborating with local legislators, regulators, and residents, DEA will be afforded unparalleled insights into the unique challenges that each state across our great nation faces. Also, as scientific and medical research unveils new understandings of cannabis use, DEA will have the means to disseminate this information quickly in a widespread and consistent manner through established community outreach channels. This dissemination will increase community education surrounding cannabis use in exponential rates. By educating would-be abusers with this cutting-edge research and information, substance abuse rates will likely fall in communities across the US. As such, DEA will further obtain its goals of reducing substance abuse and illicit drug markets nationwide.
State cannabis research markets will also promote further employment opportunities throughout the US. Establishing state research markets will afford more opportunities in every state across the US, rather than just a handful of opportunities scattered across the country among 3-15 DEA-registered manufacturers. With additional and better-quality employment opportunities, American citizens will be less likely to fall victim to substance abuse, as studies suggest. By affording additional employment opportunities to disproportionately impacted communities, DEA will continue its mission in community outreach and reducing substance abuse across the country, which will in turn also reduce illicit markets. DEA should continue its commitment to community outreach by collaborating with state regulators and state-licensed operators, allowing them to participate in the federal cannabis research program, and developing clear channels of communication to local communities across the country. These individuals will be most well-suited to utilize and disseminate information produced from the promising DEA-sanctioned research conducted as result of DEA’s rulemaking efforts.
DEA Authority to Allow Such a Program
We believe that DEA has the statutory authority to implement a federal cannabis research program that allows participation by state-licensed operators and oversight by state regulatory bodies. The FDA and National Institutes of Health support the position that DEA-licensed researchers should be able to purchase cannabis for research purposes from state-licensed operators. In August 2019, these agencies authored a letter to US Senator for Hawaii, Brian Schatz, stating they “support enabling researchers holding Schedule I [DEA] licenses for marijuana to obtain products from state-authorized dispensaries.” We believe that DEA could exercise its discretion, granted by 21 U.S.C. § 822(d) to, in the interest of public health and safety, waive DEA registration requirements for these state-licensed operators and immediately provide multiple sources of research cannabis for registered DEA researchers. These sources will provide the safest and most efficacious products available in any market today.
That said, we understand that DEA is attempting to promulgate rules for the manufacture of cannabis for medical and scientific research purposes under 21 U.S.C. § 823(a), in compliance with international treaties. In order to comply with requirements for the compliant production and distribution of medical and scientific research cannabis under the United Nations Single Convention on Narcotic Drugs of 1961, DEA must at some point in the supply chain “take physical possession” of the cannabis stock, as our country’s only Competent National Authority. We believe DEA can meet that requirement, while allowing state-licensed operators to participate, by implementing a framework similar to what was set forth by the USDA for the federal regulation of hemp production.
To provide context, the Agricultural Improvement Act of 2018 (“2018 Farm Bill”) categorized hemp (low-THC cannabis) as an agricultural commodity under the regulatory purview of the USDA. The 2018 Farm Bill now permits states and Indian Tribes to adopt their own regulatory plans governing hemp production, even if more restrictive than federal regulations, so long as the plans meet minimum federal standards and are approved by USDA. This allows the USDA to maintain oversight of the production of hemp nationwide, while leaving the burden of licensure and ongoing monitoring of those operators to state regulatory bodies. For a state to obtain USDA approval for its hemp program, it must submit a comprehensive state plan that describes how the state will track land on which the hemp is grown, testing methods, and secure disposal procedures. Once the state submits its hemp plan, the USDA reviews and approves (or denies) it within sixty days. As of this writing, multiple states have received USDA approval for their hemp plans.
We believe, in an effort to comply with international treaties, that DEA could put forth a similar program in which US states would implement federally sanctioned “cannabis research pilot programs” through rulemaking or legislation. DEA has already laid the groundwork by establishing minimum requirements for state cannabis research plans in the proposed rules in question. Individual states would then comply with these foundational federal requirements and build upon them, likely resulting in more secure and transparent programs nationwide. States would submit to DEA plans for these programs and then DEA would have the opportunity to approve or deny them. DEA could require states to submit comprehensive plans describing the source of the cannabis, its constituent components (e.g., concentrations of THC, cannabinoids, and terpenes), storage plans, security plans, disposal plans, and additional information DEA may deem relevant for its research purposes. DEA would ultimately approve the program if it met DEA’s requirements, and would remain engaged through its oversight and enforcement authority. We believe DEA approval of these plans could satisfy treaty requirements that DEA “take physical possession” of the research stock, but more importantly, it will empower state regulators who have been awaiting DEA guidance regarding state-regulated cannabis markets for years. This empowerment will afford state regulators the infrastructure to engage state-licensed operators in the production of safe, high-quality cannabis for research. Qualified state operators will then be afforded the opportunity to obtain licensure and participate in the cannabis research pilot program.
To further support DEA’s “possession” of the cannabis at any point in the supply chain, state regulators will assuredly mandate the use of secure, seed-to-sale tracking systems in state plans, like they have already done in regulated cannabis markets across the country. This software would afford DEA 24-hours a day, 7-days a week access to, as well as monitoring and oversight capabilities of, cannabis research plants at any point in the supply chain. By allowing DEA access to information surrounding the status and location of each and every cannabis research plant at any point in the supply chain, we believe DEA could “take possession of” research cannabis and preserve its government control on the federal regulation of cannabis production for medical and scientific research purposes, in full compliance with international treaties.
We strongly urge DEA to consider the aforementioned options thoroughly and implement a program that will truly enhance and improve research with “marihuana” and facilitate research that could result in the development of cannabis-based medicines approved by the FDA. State-regulated markets have some of the strictest regulations surrounding cannabis production in all of international law and policy to date, and state-licensed operators have been complying with those requirements for years. In order for DEA to best promote public health and safety, these state parties must be given a voice in the development of this new and innovative federal regulatory scheme and be allowed to participate. By collaborating with state operators and regulators, DEA will also further achieve its mission of effective community outreach and education which will in turn reduce substance abuse and illicit markets nationwide.