A scientist in a case that forced the release of a previously “secret” Justice Department document about federally authorized marijuana research this week is now calling on Congress to urge administrative action to more rapidly expand studies into the therapeutic potential of cannabis.
Sue Sisley of the Scottsdale Research Institute (SRI) and attorneys representing her facility say the Department of Justice is empowered to waive certain requirements and allow additional researchers to immediately grow their own cannabis for studies without registration under newly proposed regulations or even to obtain products from state-licensed dispensaries, for example.
They want lawmakers’ help pressuring the Trump administration to take advantage of a process they say would not necessarily violate international treaties that federal officials have long cited as a reason they’ve been slow to license new cultivators.
On Wednesday, the Justice Department’s Office of Legal Counsel (OLC) disclosed a memo that seemed to have been used by the Drug Enforcement Administration (DEA) to justify delaying approval of additional marijuana manufacturers for research purposes beyond the sole legal that scientists have had to rely on for half a century. That disclosure was the result of a Freedom of Information Act lawsuit filed by SRI last month.
Attorneys representing SRI said that the newly unveiled document helps explains what was happening behind closed doors for several years of inaction and delays after DEA initially said in 2016 that it would be approving more manufacturers.
But in their new letter to members of Congress, they identify a federal statute that they argue can be used by the attorney general to waive registration requirements, allowing research institutes to immediately grow their own cannabis for studies or to purchase it from licensed dispensaries instead of having to wait until new rigorous licensing rules go into effect.
“That Congress can fix these issues with legislation goes without saying. But what fewer recognize is that this Administration can cut through the regulatory red-tape right now,” Sisley and her lawyers wrote.
“DEA could, for example, exempt licensed Schedule I marijuana researchers from having to obtain a separate registration to manufacture marijuana, provided those researchers agree not to distribute any marijuana they manufacture. Alternatively, it could permit licensed Schedule I marijuana researchers to obtain marijuana from state-legal dispensaries. The executive’s authority to grant waivers under [federal code] is broad.”
SRI is one of dozens of applicants to become federally authorized cannabis cultivators for research purposes. It initially sued DEA three years after the agency said it would expand cultivation facilities, with SRI alleging an unlawful delay in approvals. That led the agency to announce in March that it is proposing new rules in order to process the applications.
Prior to the document’s release, it was unclear exactly what was holding DEA up from fulfilling their pledge. The OLC memo, written in 2018 but undisclosed to the public until this week, determined that DEA’s 2016 announcement about expansion would have violated international treaties—an analysis that the agency had declined to explain to applicants as their proposals languished for years.
OLC also found, however, that even the current system for marijuana research in the U.S.—which involves the National Institute on Drug Abuse contracting a single grow facility at the University of Mississippi to produce cannabis and DEA registering scientists who can obtain it—violates several provisions of international treaty obligations.
In particular, it determined that the existing process violates a provision stipulating that marijuana grown for research must be purchased and possessed by a single federal agency—a policy that DEA is seeking to adhere to under a recently revised rule change proposal released last month.
But SRI and its attorneys argue there’s a simpler solution, and that’s why they’re circulating a letter to members of Congress imploring action.
“In the United States, doing robust clinical research with marijuana should not be so difficult,” the letter from Sisley and her lawyers to members of the House and Senate says. “Scores of Americans rely on medical marijuana to treat a variety of symptoms, including our nation’s veterans and terminally ill. Not surprisingly, this issue has solid bipartisan support. It also has support among federal agencies including FDA, NIH, and DEA itself.”
While DEA’s new proposed rule change would seemingly address issues identified in the OLC memo—primarily by making it so DEA would be the sole agency in charge of possessing and purchasing cannabis for research—attorneys Shane Pennington and Matt Zorn said there’s a federal statute that would enable the Justice Department to circumvent the rulemaking process by unilaterally waiving registration requirements and setting its own regulations to abide by international treaties.
That code in question stipulates: “The Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.” Unlike other statutes concerning the issue, this one does not explicitly mention international treaty obligations.
“Plainly, given the undisputed urgency of the need for this research, waiving certain registration requirements to allow already-licensed Schedule I researchers obtain marijuana from real world or alternative sources would be ‘consistent with the public health and safety,’” the attorneys’ letter said.
Of course, the international treaties to which the U.S. is a party would still be in effect. But under the statute cited by SRI, the attorney general could theoretically impose any regulations that he felt were necessary to maintain compliance. For example, if the official were to make it so researchers could purchase marijuana from dispensaries, it could satisfy the requirement that research-grade cannabis be purchased and possessed by a single federal agency by allowing DEA to technically “own” the shop’s product.
“I should caution that it’s tough to answer these questions in the abstract because the answer in real life would depend on what the AG thought was necessary to comply with the OLC interpretation of the Single Convention,” Pennington said in an email to Marijuana Moment. He added that he is “not in any way conceding I agree with the OLC’s interpretation” but was simply speculating about how the federal government could allow researchers to immediately grow their own marijuana or study products from dispensaries while still complying with its analysis.
It was previously reported that the Justice Department, under then-Attorney General Jeff Sessions, a vociferous opponent of cannabis reform, blocked DEA from processing any of the several dozen cultivation license applications it received in response to the 2016 announcement. Attorney General William Barr views the issue differently, however, telling lawmakers that he’s pushed “very hard” to get more manufacturers approved and that he thinks “it’s very important to get those additional suppliers.”
The reason all of this matters to researchers and advocates is because of issues resulting from the monopolized cannabis supply for research purposes at the University of Mississippi. Studies have indicated that the marijuana it produces is not reflective of the cannabis sold in retail dispensaries in legal states, raising questions about the veracity of previous studies that have relied on it.
SRI, for its part, is hoping to become an approved marijuana manufacturer to supply studies into the potential therapeutic benefits of cannabis for post-traumatic stress disorder.
“Boiled down, the fact that a secret re-interpretation of an international treaty from 1961 has blocked the advancement of marijuana science in this country for the past three years is absurd,” the letter continues. “Allowing American scientists to cultivate or acquire marijuana grown in this country under strict DEA regulation and supervision is pro-science, pro-veteran, and pro-law enforcement. It puts America First and promotes public health and safety.”