The Drug Enforcement Administration (DEA) on Thursday revealed a long-awaited final rule aimed at expanding the number of authorized growers of marijuana to be used in scientific research.
In a notice set to be formally published in the Federal Register on Friday, the agency said it made “minor modifications” from the initial proposed rule on licensing cannabis manufacturers it released in March.
DEA responded to numerous public comments it received since then, breaking them down into eight categories: application process and criteria; quality of marijuana; federal agency obligations pertaining to cannabis controls; the meaning of ‘medical cannabis;’ security costs and requirements applicable to the manufacture of marijuana; harvest; cost, pricing and fees of marijuana for DEA registrants and comments outside of the agency’s scope.
The release of these finalized regulations comes as both the House and Senate have recently passed bills to promote marijuana research. The goal of those pieces of legislation is similarly to streamline the process for researchers and expand access to cannabis for studies while mandating the DEA license additional growers by specific deadlines.
The House legislation contains a key provision that would allow scientists to access cannabis from state-legal dispensaries so that they can study products that are actually being used by consumers in commercial markets. In DEA’s new filing, the agency pushed back against public comments that suggested researchers be able to obtain dispensary marijuana.
Overall, DEA has maintained throughout the rulemaking process for licensing additional growers that it will have sole ownership over any marijuana that’s cultivated for research purposes.
That’s a fundamental change from current policy. As it stands, a single facility at the University of Mississippi is authorized to grow cannabis through a contract with the National Institute on Drug Abuse, and DEA does not maintain ownership over its products.
But DEA now asserts that in order to comply with international law, it must institute a practice of “taking possession of marihuana crops after harvest and maintaining the exclusive right of importing, exporting, wholesale trading, and maintaining stocks of marihuana and its resin.”
That’s based on an interpretation of the Single Convention by the Justice Department’s Office of Legal Counsel, which determined in April that DEA has been violating the international treaty by managing the cannabis program in coordination with two other agencies when it needs to be the sole agency.
Here’s an overview of some of the most notable responses and regulatory amendments in the new DEA filing:
-Many commenters argued that DEA should not disqualify applicants who’ve grown marijuana in compliance with state law. The agency responded that it is statutorily bound to consider instances where an applicant violated federal law—something that all state-legal marijuana cultivation businesses do—and it would continue to do so. “While the DEA Administrator has discretion to weigh the statutory factors and any one factor need not be dispositive, an applicant’s prior compliance with Federal law is a relevant consideration when determining whether to grant an application for registration,” the notice states.
-Relatedly, the agency responded to comments pushing it to factor in an applicant’s ability to produce “high quality” marijuana and their past experience cultivating the plant. It simply said that applicants are judged based on public interest and compliance with international treaties. “Under those factors, DEA will consider the applicant’s ‘past experience in the manufacture of controlled substances’ and its ‘promotion of technical advances in the art of manufacturing these substances.’”
-DEA also said it would not be allowing researchers to obtain marijuana products from state-legal cannabis businesses. It cited international treaty obligations and federal statutes, as well as public safety considerations. The agency also said that extending that access is “unnecessary” since it will be expanding the number of DEA-registered manufacturers.
-Since DEA first announced in 2016 that it would be expanding the number of marijuana cultivators, it received more than 30 applications but has yet to act on them. (This has led to several lawsuits, with scientists pushing the courts to mandate that the agency respond.) DEA said in the final rule that it would be prioritizing those applications before moving on to review new ones.
-The agency rejected pushback on the proposed rule’s provisions that specifically exempt it from liability for marijuana that’s damaged or destroyed under its possession. But DEA stressed that it only handles cannabis for a short time and it will maintain the statute of non-liability in order to “avoid costly and unnecessary disputes.”
-There were comments challenging DEA’s interpretation of international policies and what they mean as far as restrictions on cannabis research are concerned. The agency said it “acknowledges some may disagree with these legal conclusions, but DEA is bound by the law as [the Justice Department] and DEA understand it.” It said that questions about whether international treaties or the Controlled Substances Act controls of marijuana should be amended or abandoned “are beyond the scope of this rulemaking and DEA’s authority.”
-One of the allegations DEA has faced since announcing its intent to expand manufacturing facilities in 2016 is that it used a “secret” internal Justice Department memo to justify delaying additional application approvals. The agency said that DOJ reviewed its 2016 statement and concluded that rules would need to be changed in order to make those approvals. It “has acted as expeditiously as possible to amend its policies,” the notice states.
-Several commenters made the argument that DEA should relinquish control of the marijuana growers program and give that responsibility to an agency such as the U.S. Department of Health and Human Services, National Institutes of Health, Food and Drug Administration or U.S. Department of Agriculture. The agency said it works in concert with those other government entities and would continue to do so, but it is statutorily obligated to maintain sole control.
-DEA said it would not be taking special steps to “ensure diversity and inclusion of minority applicants.” The agency said it “gives all applicants equal treatment regardless of the gender, race, socioeconomic status, or disabled status of the applicant.”
-DEA said that multiple factors mean that it cannot significantly streamline the process of approving applications to become cannabis manufacturers for studies, despite the multiple requests it received. However, it did pledge to provide notice that an application was received within 90 days of its accepted filing.
While the final rule clears up some uncertainty about the DEA’s perspective on advancing marijuana research as Congress moves forward with its own plans, advocates have already taken issue with several of the agency’s responses to the comments.
“Time and time again, the DEA has proven itself full of empty promises when it comes to the issue of facilitating clinical cannabis research in the United States,” Paul Armentano, deputy director of NORML, told Marijuana Moment. “This history of inaction is why Congress needs to enact legislative reforms.”
He added that the bill recently passed by the House would end “the DEA’s longstanding fiefdom” by allowing scientists to study cannabis products available in state-licensed dispensaries, whereas the agency’s new proposal shows it is “not willing to make the sort of substantive changes necessary to provide U.S. scientists with the tools they need to adequately do their job.”
Without a clear directive from Congress, Armentano said, “there is little reason to believe that the DEA will ever act in a manner that will facilitate the changes necessary to put science first and politics second.”
Corey Cox, a senior associate attorney at Vincente Sederberg LLP, shares that perspective.
“My primary takeaway from this is it just really emphasizes the importance of pursuing legislative reforms through Congress—that the existing framework of the [Controlled Substances Act], as interpreted and implemented by the DEA, is really incompatible with the types of reforms that many stakeholders seem to be seeking through this rulemaking process,” he said.
“I think for members of Congress that are maybe on the fence, this really shows that the existing statutory framework—the CSA, the DEA’s interpretation of the CSA, the rules they promulgated pursuant to that act—are really incompatible with some of the goals and objectives Congress seems to be pursuing through these research bills,” he said.
This story has been updated to include additional details and commentary on the final rule.
Read the DEA final rule on expanding marijuana research below: