There are less than two weeks left for people to submit comments on the Drug Enforcement Administration’s (DEA) proposed rule change that the agency says will enable it to increase the number of authorized growers of marijuana to be used in scientific studies.
Yet despite this major development, which includes a large-scale overhaul of the federal marijuana research program that grants DEA broadly expanded powers and controls, there appears to be relatively little public interest in providing feedback on the proposal so far—at least compared to previous cannabis-related rule changes that other federal agencies have posted.
When the U.S. Department of Agriculture (USDA) opened a comment period for proposed regulations on hemp last year, for example, more than 4,600 people replied.
But as of Wednesday, just 31 people or organizations have weighed in on the new DEA notice that stands to have a lasting impact on marijuana research in the country and represents the culmination of a years-long conflict between scientists and the agency.
Four years ago, DEA pledged to expand cannabis cultivators for studies. Dozens of research institutions submitted applications, only to hear silence. A lawsuit alleged that DEA was deliberately delaying the process, leading the agency to issue an update last year stipulating that the application procedure had to be revised.
It turns out that there was more to that story. The scientist behind that lawsuit filed another case citing the Freedom of Information Act, requesting the disclosure of a “secret” Justice Department document she claimed was used to justify inaction on the applications. As part of a settlement, the department published a 2018 Office of Legal Counsel memo this month that concluded DEA was in violation of international treaties that dictate how member nations must approach the production of controlled substances.
The office further determined that in order to be in compliance, a single agency needed to control the possession and purchasing of marijuana for research. Currently, DEA registers scientists to obtain cannabis, which is grown by a third-party farm at the University of Mississippi that is overseen by the National Institute on Drug Abuse (NIDA). DEA’s proposed rules would make it the sole agency in charge of research-grade cannabis, a change it says will put it in compliance with treaty obligations.
Generally speaking, researchers applauded the moves to authorize new growers, as it signals that the University of Mississippi monopoly on marijuana for research could soon be ending. That’s especially important given concerns about the quality of cannabis grown at the facility. One study found that its plants are chemically more similar to hemp than marijuana that is available to consumers in state-legal markets.
But not everyone is pleased with the details of the proposed rule change.
With the deadline for public comments fast approaching, here’s a look at what people and organizations are telling DEA about its proposal:
One of the major voices opposing the specifics of the new rules is NORML, which argued in its formal comment that DEA does not have the track record to inspire confidence that the agency is making a good faith effort to expand cannabis research.
“While NORML has long supported facilitating and expanding domestic clinical research efforts, we do not believe that these proposed rules, if enacted, will achieve this outcome,” the group said. “Rather, we believe that the adoption of these rules may further stonewall efforts to advance our scientific understanding of cannabis by unduly expanding the DEA’s authority and control over decisions that ought to be left up to health experts and scientists.”
“NORML opposes the DEA’s proposed rules and, instead, proposes a more practical alternative to facilitate clinical cannabis research in the United States,” the comment continues. “Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, NORML believes that federal regulators should allow investigators to access the cannabis that is currently being produced by the multitude of state-sanctioned growers and retailers throughout the country.”
The National Cannabis Industry Association (NCIA) said it broadly opposes DEA’s proposed regulations, contending that as a law enforcement agency, it would be inappropriate for it to govern production and research into cannabis. NCIA raised a series of concerns and said the rules should either be dramatically amended or withdrawn entirely.
Chief among its recommendations would be for a public health agency like the National Institutes of Health to be responsible for domestic cannabis production for research purposes and to make it so marijuana cultivators that have been operating in compliance with state laws be eligible for grow the plant for studies.
As it stands, DEA’s proposal stipulates that applicants can be denied if they’ve violated the federal Controlled Substances Act—something all existing state-legal marijuana cultivation businesses have technically done.
“The federal government should be incentivizing research, not discouraging it,” NCIA said, adding that it should work to “create a pathway for less restrictive means by which the country can access important information about the medicinal properties of cannabis.”
The advocacy group Americans for Safe Access (ASA) said that while it is “in favor of expanding the production of research grade cannabis and supports research that can potentially lead to the approval by the FDA of cannabis based medicine,” the group is “skeptical of the DEA’s administration of the program and new framework design.”
ASA made several recommendations in the draft comment that has not yet been filed but was shared with Marijuana Moment, including ensuring that there is a “not-for-profit wholesaling scheme to distribute research grade cannabis” and allowing state-legal cannabis producers to participate in the program.
It also wants to remove NIDA from conducting medical cannabis research altogether due to an “unscientific agenda” it has demonstrated over its decades of controlling the process. ASA also suggested that if DEA “should fail to provide adequate licensure or unfairly distributes research grade cannabis (as they have in the past)” the agency should be stripped of its authorities and replaced with a new Office of Medical Cannabis Control.
“Increased access, exposure, and broader normalization of cannabis have deeply affected the American consciousness,” the group said. “Cannabis has become a more popularized form of medicine.”
An individual going by the name of Eric D. offered an interesting perspective in a separate comment, urging DEA to “include provisions to ensure equal opportunity to small- and mid-sized growers.”
“For example, reasonable application and processing fees, especially early in the application process, so the barriers to entry are not insurmountable for some applicants, while being insignificant for others,” the comment states. “Cannabis, unlike other medicines, can be produced by novice growers. It is of great concern that in the event that federal regulations for production become more permissive, a small group of producers will gain control of the entire market.”
Maridose, a company that said was formed because of DEA’s 2016 announcement about research expansion, said it is supportive of the proposed rule changes, though it outlined a series of questions it hoped the agency would clarify.
The company argued it would be helpful if DEA could clarify how the price of cannabis products it purchases will be determined, how it will ensure that there’s competition and availability of different marijuana varieties for researchers and what the packaging and shipping requirements will be for manufacturers.
“While remaining federal compliant and not currently involved in any Federal or State cultivation activities Maridose has developed strategic partnerships with world-renowned researchers and institutions with strong records of legal cannabis cultivation and biopharma research,” the comment states. “If granted a license by the DEA Maridose will be able to provide the highest quality standardized cannabis and cannabis extracts to meet the needs of groundbreaking lines of scientific inquiry.”
Another applicant, Biopharmaceutical Research Company, said it has also been compliant with the Controlled Substances Act by not growing cannabis to date, and argued that it has “undertaken this enterprise as a business, at great risk, because we believe in the importance of compliant and top-quality federal research.” While the company generally supports the agency’s regulations, it recommended making a change so that the current pool of applicants who have had their proposals pending for years are prioritized.
Those comments are some of the very few that have been submitted so far that are specifically responsive to the proposed rule change.
Others put their views more bluntly, calling for the end of prohibition altogether—including one from R. Michelle Anderson that quotes Nixon administration official John Ehrlichman about the racist intent behind marijuana criminalization enforcement.
“Making the rules even more complicated by adding another step just inflates the DEA coffers at the expense of the taxpayer, contributing to our bloated bureaucracy, while adding no needed benefit,” an anonymous commenter said, adding that they feel the rulemaking is the product of DEA’s “unwillingness to accept marijuana reform and impending federal legality, and therefore, are making it more difficult to study in an effort to maintain their position and status.”
North Dakota resident Blaine Hulbert said DEA has “had YEARS to get this done.”
“We would appreciate true action this time as well as DEREGULATING and FREEING of product to be housed at the facilities that are doing the research,” the comment says. “We know once it disappears into your coffers, we never hear any more about it.”
The deadline to submit comments on DEA’s proposed marijuana rule change is May 22.
USDA Approves Hemp Plans For Six Additional States And Three Indian Tribes
The U.S. Department of Agriculture (USDA) has signed off on hemp plans for six additional states and three Indian tribes this month, with a new batch of approvals coming on Friday.
Illinois, Indiana, Michigan, New Mexico, Oklahoma and South Dakota each had their regulatory proposals accepted within the past two weeks, as did the Comanche Nation, the San Carlos Apache Tribe of Arizona and the Seminole Nation of Oklahoma.
That raises the total number of approved plans to 69.
USDA has been signing off on hemp proposals on a rolling basis over the past year. Last month, it accepted plans from Utah and the Torres Martinez Desert Cahuilla Indians.
The South Dakota Department of Agriculture (SDDA) has received final approval by the United States Department of Agriculture (USDA) for the South Dakota Industrial Hemp Plan.
— SD Dept of Ag (@SDAgriculture) October 16, 2020
Illinois and Oklahoma were among a group of states that USDA had asked to revise and resubmit their initial proposals in August.
While the agency released an interim final rule for a domestic hemp production program last year, industry stakeholders and lawmakers have expressed concerns about certain policies it views as excessively restrictive.
USDA closed an extended public comment period on its proposed hemp regulations earlier this month. Its initial round saw more than 4,600 submissions, but it said last month that it was reopening the feedback period in response to intense pushback from stakeholders on its original proposal.
The federal Small Business Administration (SBA) said last month that the new 30-day comment window is too short and asked USDA to push it back, and it also issued a series of recommended changes to the interim final rule on hemp, which it says threaten to “stifle” the industry and benefit big firms over smaller companies.
All told, it appears that USDA is taking seriously the feedback it’s received and may be willing to make certain accommodations on these particular policies. The department’s rule for hemp is set to take effect on October 31, 2021.
In July, two senators representing Oregon sent a letter to Perdue, expressing concern that hemp testing requirements that were temporarily lifted will be reinstated in the agency’s final rule. They made a series of requests for policy changes.
Senate Minority Leader Chuck Schumer (D-NY) wrote to Perdue in August, asking that USDA delay issuing final regulations for the crop until 2022 and allow states to continue operating under the 2014 Farm Bill hemp pilot program in the meantime.
Sen. Cory Gardner (R-CO) also called on USDA to delay the implementation of proposed hemp rules, citing concerns about certain restrictive policies the federal agency has put forward in the interim proposal.
The earlier pilot program was initially set to expire on October 31, but it was extended to September 2021 through a congressional continuing resolution that the president signed late last month.
The senators weren’t alone in requesting an extension, as state agriculture departments and a major hemp industry group made a similar request to both Congress and USDA in August.
Perdue has said on several occasions that DEA influenced certain rules, adding that the narcotics agency wasn’t pleased with the overall legalization of hemp.
Amid the coronavirus pandemic, hemp industry associations pushed for farmers to be able to access to certain COVID-19 relief loans—a request that Congress granted in the most recent round of coronavirus legislation.
While USDA previously said that hemp farmers are specifically ineligible for its Coronavirus Food Assistance Program, that decision was reversed last month. While the department initially said it would not even reevaluate the crop’s eligibility based on new evidence, it removed that language shortly after Marijuana Moment reported on the exclusion.
Two members of Congress representing New York also wrote a letter to Perdue in June, asking that the agency extend access to that program to hemp farmers.
Hemp farmers approved to produce the crop do stand to benefit from other federal loan programs, however. The department released guidelines for processing loans for the industry in May.
Meanwhile, USDA announced last week that it is planning to distribute a national survey to gain insights from thousands of hemp businesses that could inform its approach to regulating the industry.
AOC Wants To Work With Republicans To Legalize Marijuana And End War On Drugs
Democrats and Republicans might be divided on a number of major policy issues, but Rep. Alexandria Ocasio-Cortez (D-NY) said on Thursday that ending the drug war and legalizing marijuana are increasingly standing out as exceptions to hyper-partisanship in Congress.
The congresswoman made the point during a virtual town hall alongside cannabis reform ally Rep. Earl Blumenauer (D-OR), stating that since she took office, it’s been encouraging to see members on both sides of the aisle come together on issues concerning “civil rights policy and civil liberties,” including ending “drug prohibition laws.”
“We’ve been able to propose solutions on a wide spectrum towards decriminalization, towards legalization, and that is increasingly becoming a position that more Republicans are amenable to,” she said.
For example, her spending bill amendment to divert $5 million in funding from the Drug Enforcement Administration to an opioid treatment program was approved without opposition in the House last year, Ocasio-Cortez said.
“That’s defund before defund became a widespread demand that we heard this year—and Republicans supported it,” she said, referencing progressive calls to defund law enforcement amid protests over police killings of black Americans. “So there are some areas where you can find common ground.”
Blumenauer also said at the event that “part of why we are fighting so hard to eliminate the failed prohibition on cannabis is because that’s been a tool that’s been used against people of color in particular that has horrific consequences and helps fuel that prison pipeline that has wreaked such havoc on our communities.”
To that end, Ocasio-Cortez said that, beyond federally legalizing cannabis, it’s important for lawmakers to ensure that any regulated markets that emerge are structured in a way that encourages participation by communities most hurt under prohibition.
“There are different ways that we can go about legalizing cannabis in the United States, and you can go about it in a way that concentrates power in a [Big Agriculture] way that concentrates power in big banks and that cuts out small mom and pops,” she said. “And then there’s another path towards legalization where everyday people and especially the black and brown communities that have been disproportionately impacted by the war on drugs can be at the front of the line of enjoying the economic benefits of legalization.”
“I think we’re just so past due to make sure that we’re legalizing cannabis in the United States and that we’re expunging people’s records from the absolutely unjust war on drugs,” the congresswoman said. “It is an incredible priority.”
New York Will Legalize Marijuana By April And Regulate CBD-Infused Drinks, Governor’s Advisor Says
The top marijuana advisor to New York Gov. Andrew Cuomo (D) says cannabis legalization legislation will again be introduced through the state budget in January, with the goal being to enact the reform by April. He also previewed state regulations for hemp-derived CBD products, including allowing infused drinks and food items.
During an interview with Canopy Growth Corp.’s David Culver on the company’s recently launched video series, “Under The Canopy,” Assistant Counsel Axel Bernabe talked about how efforts to legalize marijuana in surrounding states underscore the need for reform in New York. And he said the legislation the governor will be introducing will serve as a “model” for other states, prioritizing social equity and economic development.
In this episode of #UnderTheCanopy we speak to Axel Bernabe of @NYGovCuomo's office who answered our questions on New York’s upcoming #hemp regulations, #cannabis #legalization, and the Gov.’s pandemic response. Watch here: https://t.co/5SzWFMnFSU
— Canopy Growth (@CanopyGrowth) October 14, 2020
But he also recognized that neighboring New Jersey may beat the Empire State to the punch, as voters are positioned to approve a legalization referendum next month.
“We’re watching New Jersey closely. We’ve always been confident that we get to this before New Jersey, so if they pass the referendum they still have to have agreement between the governor the Senate over there,” he said, referring to necessary implementing legislation that will need to be approved if voters pass the ballot question. “We’re working on this. We’re going to reintroduce this in our budget in January. We think we can get it done by April 1.”
That said, a top New Jersey senator recently indicated that lawmakers in the Garden State could pass the enacting bill as soon as the first week of November.
Over in New York, Cuomo has included legalization in his budget proposal for the last two years, but negotiations have consistently stalled out in the legislature, with sticking points such as how cannabis tax revenue will be allocated preventing a deal from being reached.
“If Jersey can beat us to it, then they’ll get the gold star—but I still think we’re going to set the model here.”
Bernabe said he’s especially excited about the public safety and economic development components of the administration’s forthcoming legalization proposal. And he spoke about the need to ensure social equity for communities historically targeted by the war on drugs, adding that there will be some changes from this year’s version in light of other states’ experiences.
“I would say equity pervades the entirety of the bill. It pervades it on the licensing front, it’s on the revenue side and the use of funds and providing capital and loans,” he said.
Also in the interview, Bernabe talked about pending regulations for hemp-derived cannabinoids. While those who grow the crop for fiber, seeds and other agricultural purposes are covered under existing rules, he said the administration is “literally putting the final tweaks” on policies for consumer CBD products that will take effect at the beginning of 2021.
“We’re excited because we’ve taken the bull by the horns so to speak. I think people recognize that there are a lot of sectors or product lines that haven’t really had some thorough regulation attached to them,” he said. “You can pick a number of them but probably the most high-profile or obvious ones are something like vapes—so CBD or other cannabinoid extract vapes. Flower, even some tinctures, and foods and beverages.”
“How do you regulate that? What are the parameters around it? What’s permissible? What’s not?” he said. “We dug deep. I don’t know that we’ll get everything right. We had to make some calls.”
NY is on the cusp of opening their hemp market – but what went into the regulatory process to make this a reality? Axel Bernabe from @NYGovCuomo's office discusses this & all things cannabis-related in this episode of #UnderTheCanopy Click here to watch: https://t.co/5SzWFMnFSU pic.twitter.com/HEK351bG5o
— Canopy Growth (@CanopyGrowth) October 18, 2020
The administration official offered an example of a regulation they’re likely to pursue that other states have avoided: creating rules for cannabinoid-infused drinks and food items.
“We think of this in terms of consumer protection. Those products are already out there. There’s no sense in trying to pretend they’re not,” he said, adding that one way they’re planning to ensure those protections is to set a maximum 25 milligram CBD dose per serving.
“We’re really doing it across the board on this,” Bernabe said. “We’re really looking at every product class and trying to strike a balance between consumer protection and letting people have what they’re obviously using extensively for health and wellness.”
As the administration finalizes those rules, the state’s hemp industry also recently got some news about broader regulations. Since a congressional continuing rider signed by the president last month extends the 2014 Farm Bill pilot program for the crop until next September, the New York Agriculture Department said it will similarly allow hemp businesses to continue to operate under the existing program until September 30, 2021.
“With so much uncertainty right now, we applaud [the department’s] move to extend these rules,” Allan Gandelman, president of the New York Cannabis Growers and Processors Association, said in a press release on Wednesday.
Photo courtesy of Mike Latimer.