The irony is not lost on the hemp industry.
In 2018, Congress removed hemp from the Controlled Substances Act (CSA), stripping the Drug Enforcement Administration (DEA) of oversight of a cannabis-derived substance now treated as an agricultural crop.
But laboratories that test Farm Bill-compliant hemp must presently be registered with DEA, per interim regulations published Oct. 31 by the U.S. Department of Agriculture (USDA).
The requirement is burdensome and costly, and will cause complications for labs that have been testing both hemp and marijuana under state cannabis programs, according to industry sources.
“The most frustrating thing for a lot of people … has been the DEA’s involvement in this,” said Eric Steenstra, president of Vote Hemp, a grassroots advocacy organization, commenting on USDA’s rules. “Congress removed this from the Controlled Substances Act to get the DEA out and explicitly said that USDA was the regulatory agency on this, and yet they have come back into this … in multiple different ways.”
Under the 2018 Farm Bill, Congress defined hemp as containing no more than 0.3% THC, the psychoactive compound found in high quantities in marijuana. Anything above that threshold is technically a controlled substance subject to DEA’s jurisdiction.
“Laboratories who conduct THC testing must also be registered with DEA to handle controlled substances under the CSA and DEA regulations,” USDA stated in its regulations.
USDA cited “the potential for these laboratories to handle cannabis products testing above 0.3% THC.”
“Such products are, by definition, marijuana, and a controlled substance,” the agency explained. “DEA registration requirements verify a laboratory’s ability to properly handle controlled substances.”
Steenstra, however, described the requirement that labs be registered with DEA as “completely unnecessary.”
“It doesn’t have anything to do with quality,” he said in an interview. “It’s purely about DEA being able to monitor the lab.”
Not all facilities testing hemp are registered with DEA, noted Garrett Graff, managing attorney with Hoban Law Group in Denver.
“Those existing labs [registered with DEA] do not have the bandwidth or capacity to be the exclusive testing provider to the hemp industry,” Graff said in an interview.
Graff added, “The process to become DEA registered and the procedures necessary to maintain DEA registration are exhaustive, onerous and costly both in time and money.”
Corey Cox, an associate attorney in Denver with Vicente Sederberg LLP, said he’s consulted with clients who have reported they cannot identify a DEA-registered lab within the state where they are operating, or the only registered facility is a forensics lab for state law enforcement.
“There’s significant concerns around capacity and there being enough testing labs to test all the hemp that will be cultivated and harvested next year,” he said in an interview.
Under USDA rules, samples tested must be collected within 15 days of harvest. Outdoor hemp will be harvested in the fall of 2020, though Cox pointed out some indoor grows operate year-round.
Since USDA’s rules took effect immediately, labs that aren’t registered with DEA are “suddenly no longer qualified to test hemp,” Streenstra said.
Asked about the registration process, a DEA spokeswoman, Mary Brandenberger, said in an email, “We are currently working with USDA to formalize a process for becoming a DEA-registered lab.”
She did not provide further information in response to a request for comment on the number of U.S. labs registered with the agency, the costs of registration and how long it takes to get registered.
Scott Hansen, vice president of quality and regulatory affairs with Denver-based Botanacor Laboratories, which tests hemp, said on Nov. 11 he filled out an application to become registered with DEA.
“Do I know how long that process is going to take?” Hansen asked during an interview. “No.”
Christopher Hudalla, Ph.D., is founder and chief scientific officer of ProVerde Laboratories in Milford, Massachusetts. Asked about registering with DEA, he said, “We’re all in the blind trying to find our way here. Until there’s some clarity, there’s going to be some challenges.”
He identified a conundrum facing labs that currently test hemp for compliance and separately marijuana under programs regulated by states.
“In Massachusetts, where we test medical marijuana, I am prohibited—as far as I understand—from having a DEA registration,” he said in an interview. “When I apply for a DEA registration, one of the first things they’re going to ask me to do is to sign a document saying I will abide by federal law. The problem is everything I do in terms of state marijuana is federally illegal.”
USDA’s rules, Cox said, exclude companies that test state-regulated marijuana products.
“These labs also test a lot of hemp and have significant operational experience testing the cannabis plant,” the attorney added. “By excluding those labs, we’re not only impacting … the available testing capacity, we’re also excluding businesses with significant operational experience testing this specific plant.”
Even if Hudalla could become registered with DEA, he said any hemp samples that test beyond the 0.3% THC threshold will need to be stored under more secure conditions than state-regulated marijuana.
“The stuff with the lowest THC is going to be stored under the most stringent conditions, whereas my high-marijuana, high-THC product doesn’t need that level of storage,” he explained.
Providing testing services to the hemp and marijuana industries allows his lab to achieve greater volume, which enables the business to offer lower prices, Hudalla suggested.
If he’s registered with DEA, Hudalla expressed concern that he will only be allowed to test for hemp and anyone participating in research sourcing cannabis from the University of Mississippi. According to University of Mississippi, it’s the only one DEA has authorized to grow marijuana under a contract with the National Institute of Drug Abuse.
“That means that testing is going to be more expensive,” Hudalla predicted.
Until marijuana is legalized federally, Hansen said he views the DEA registration requirement as a “necessary evil because depending on the [THC] number,” a lab will be handling either hemp or marijuana.
But industry remains concerned over the seemingly arbitrary distinction between marijuana and hemp. Hemp exceeding the 0.3% threshold, Cox said, is treated as marijuana under USDA's rules rather than how industry has treated such material—as a substance that under state-regulated programs might have to be destroyed or be subject to limitations on its use, but was still viewed as “hot hemp” since it obviously wasn’t marijuana high in THC.
“Under these rules, it’s clear that that is not the case,” the lawyer said. “There’s no real … context of ‘hot hemp.’ That plant material is just viewed as marijuana.”