The U.S. Department of Agriculture (USDA) released draft rules for hemp manufacturing on Tuesday and said it will soon begin accepting state regulatory plans for the newly legal crop.
The interim final rule on hemp will be formally published in the Federal Register on Thursday, with a 60-day public comment period to follow. Once the rules are finalized, USDA will begin to evaluate states’ and tribes’ submitted regulations plans, and any jurisdictions that do not send proposals will fall under the department’s general guidelines for producing the crop, which was federally legalized under the 2014 Farm Bill.
The regulations cover the requirements for where hemp can be grown, THC testing standards, the disposal process for crops that don’t meet federal standards and licensing protocols.
The regulation provides specific details on the process and criteria for USDA’s review of plans received from states and Indian tribes regarding the production of #hemp.
For more info and resources: https://t.co/E0qdkW3iY9 pic.twitter.com/7lMx3Ou484
— USDA Ag Mktg Service (@USDA_AMS) October 29, 2019
“At USDA, we are always excited when there are new economic opportunities for our farmers, and we hope the ability to grow hemp will pave the way for new products and markets,” USDA Secretary Sonny Perdue said in a press release.
At USDA, we are always excited when there are new economic opportunities for our farmers, and we hope the ability to grow hemp will pave the way for new products and markets. More on our new Domestic Hemp Production Program HERE: https://t.co/7Bz7zcGQmK pic.twitter.com/bkSLcM91mI
— Sec. Sonny Perdue (@SecretarySonny) October 29, 2019
“We have had teams operating with all hands-on-deck to develop a regulatory framework that meets Congressional intent while seeking to provide a fair, consistent, and science-based process for states, tribes, and individual producers who want to participate in this program,” he added.
After the regulations are finalized, USDA said it will make a determination about state or tribal plan applications within 60 days of their submission. Jurisdictions that submit applications to process hemp under USDA’s guidelines rather than their own local rules will be reviewed within 30 days of their submission. Prospective state or tribal applicants can obtain the necessary forms here.
The interim rule will sunset in two years, after which point USDA will issue final regulations.
Multiple lawmakers and industry stakeholders celebrated the announcement, emphasizing that federal guidelines will further empower hemp businesses to thrive.
Shawn Hauser, partner and chair of the hemp and cannabinoids practice group at Vicente Sederberg LLP, said that “there is an undeniable sense of progress that comes with reading federal regulations for hemp farming in the U.S.—something that was outlawed for decades, which so many people fought to achieve.”
But not all of the specific details are positive, she said.
“Many people will be disappointed to see such stringent enforcement provisions related to concerns about hemp exceeding legal THC limits. For example, the rules require disposal of ‘hot hemp’ by a federal agent, even if there are reasonable options to remediate it and avoid loss of a crop,” Hauser said, referring to plants that exceed legal THC limits. “These provisions feel like relics of prohibition and come at a risk and expense to farmers, but they do not come as a surprise. It takes time to transition from prohibition to a regulatory model.”
USDA is simultaneously issuing separate guidelines for sampling and testing procedures for hemp. Samples, which have to be collected about two weeks prior to a crop’s anticipated harvest date, must be tested at Drug Enforcement Administration (DEA)-registered laboratories.
📢📢 @SecretarySonny today announced the establishment of the U.S. Domestic Hemp Production Program. This program, as required by the 2018 #FarmBill, creates a consistent regulatory framework around #hemp production throughout the U.S. https://t.co/5edNG1FnZ3 pic.twitter.com/xgSff5uDJm
— Dept. of Agriculture (@USDA) October 29, 2019
Hemp is defined under the farm bill as having 0.3 percent THC on a dry weight basis. USDA clarified that testing protocol will involve an analysis of the total THC content, including THCA, which can be converted into the traditional psychoactive compound upon decarboxylation.
The plan also establishes “an acceptable hemp THC level” that accounts for uncertainty in the cultivation process.
“For example, if the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis is 0.35% and the measurement of uncertainty is +/- 0.06%, the measured delta-9 tetrahydrocannabinol content concentration level on a dry weight basis for this sample ranges from 0.29% to 0.41%,” USDA explained. “Because 0.3% is within the distribution or range, the sample is within the acceptable hemp THC level for the purpose of plan compliance.”
If the THC content is found to be unacceptable, however, it must be destroyed by someone authorized under the Controlled Substances Act to handle marijuana, such as a DEA registrant. A USDA official confirmed on a press call Thursday that hemp that falls outside of the acceptable THC level will not be covered by federal crop insurance.
Another provision of concern for advocates is the implementation of a 10-year ban on participation in the hemp industry by individuals with prior felony drug convictions. USDA said that ban will only apply to “key participants” such as chief executives who have a direct financial interest in the business. That means personnel such as maintenance workers will be exempt from the ban, which is in line with the narrow interpretation that advocates pushed for.
The draft document does not address the rules around whether smokable hemp flowers may be sold, which is likely because such products would fall under separate jurisdiction of the Food and Drug Administration (FDA). That absence of rules doesn’t necessarily indicate that USDA is permitting smokable hemp but the lack of clarity on the issue for now leaves room for interpretation at the state level.
The public release of the proposed regulations comes days after the White House Office of Management and Budget (OMB) finalized its review of USDA’s interim final rule. Once the regulations are finalized, hemp farmers will be eligible for a series of federal agriculture programs, including crop insurance. Previously, USDA said farmers could only gain coverage under the 2014 version of the farm bill.
The department also clarified the rules on importing and exporting hemp seeds and plants this month—however, the interim rule states that it “does not affect the exportation of hemp” and notes that USDA will work with partners on an exportation plan if there’s sufficient interest. USDA also said in August that it would accept intellectual property applications for seed-propagated hemp.
Meanwhile, lawmakers are still pushing FDA to issue rules for CBD products, which most hemp businesses are using the crop for at this point. The agency said their rulemaking process is complicated by the fact that CBD exists as an FDA-approved drug and hasn’t been previously added to the food supply. Former Commissioner Scott Gottlieb said it may take years before regulations are issued unless Congress takes action.
Read the draft USDA hemp rules below:
This piece was updated to include information about USDA’s proposed regulations and to include comments from Hauser.
Photo courtesy of Pixabay.
Virginia Has Sealed 64,000 Marijuana Distribution Charges Since Legalization Took Effect This Summer
“These aren’t just numbers and there are families attached.”
By Ned Oliver, Virginia Mercury
Virginia has sealed records documenting more than 64,000 misdemeanor marijuana distribution charges since the state legalized the drug in July.
The figure came out Thursday during a meeting of the legislature’s Cannabis Oversight Commission.
Officials said the records were scrubbed from the state’s criminal record database, which is used by employers like school boards, state agencies and local governments to screen employees.
The state had already sealed 333,000 records detailing charges of simple possession last year after the state reduced the offense to a civil infraction on par with a traffic offense, said Shawn G. Talmadge, the Deputy Secretary of Public Safety and Homeland Security.
Lawmakers directed the state to expand that effort when they voted to broadly legalize recreational use of marijuana earlier this year.
The legislature also agreed to a broader expungement reform that will automatically seal other misdemeanor charges, including underage possession of alcohol, use of a fake ID, petit larceny, trespassing and disorderly conduct. Talmadge said those charges will remain in the system until the state finishes updating the software it uses to track criminal records.
“As of right now, the process is proceeding,” he said.
The Virginia Joint Commission on Cannabis Oversight is meeting now. You can find the agenda and links to livestream and to provide public comment at https://t.co/f1wsPn7SV7
— Jennifer McClellan (@JennMcClellanVA) October 14, 2021
Members of the oversight commission also heard from two advocates who urged them to move fast to address people currently imprisoned for marijuana offenses—a category of people the legalization legislation passed this year did not address.
Chelsea Higgs Wise, the leader of the advocacy group Marijuana Justice, and Gracie Burger, with the Last Prisoner Project, said Department of Corrections data suggests there are currently 10 people being held solely on serious marijuana charges.
They said it remains unknown how many more are being held because of marijuana related probation violations.
“These aren’t just numbers and there are families attached,” Burger said.
DEA Proposes Dramatic Increase In Marijuana And Psychedelic Production In 2022, Calling For 6,300 Percent More MDMA Alone
The Drug Enforcement Administration (DEA) is proposing a dramatic increase in the legal production of marijuana and psychedelics like psilocybin, LSD, MDMA and DMT to be used in research next year.
In a notice scheduled to be published in the Federal Register on Monday, the agency said there’s been a “significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” and it wants authorized manufacturers to meet that growing demand.
DEA had already massively upped its proposed 2021 quota for cannabis and psilocybin last month, but now it’s calling for significantly larger quantities of research-grade marijuana and a broader array of psychedelics to be manufactured in 2022.
It wants to double the amount of marijuana extracts, psilocybin and psilocyn, quadruple mescaline and quintuple DMT. What especially stands out in the notice is MDMA. The agency is proposing an enormous 6,300 percent boost in the production of that drug—from just 50 grams in 2021 to 3,200 grams in the coming year—as research into its therapeutic potential continues to expand.
LSD would see a 1,150 percent increase, up to 500 grams of the potent psychedelic.
Marijuana itself would get a 60 percent boost under DEA’s proposal, up to 3.2 million grams in 2022 from the 2 million grams last year.
Here’s a visualization of the proposed quota increase from 2021 to 2022 for marijuana and cannabis extracts:
For all other THC, psilocybin, psilocyn and MDMA:
And for other psychedelic substances like LSD, mescaline and DMT:
DEA said in the Federal Register notice that it has been receiving and approving additional applications to “grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes” to achieve these ambitious quotas.
“DEA supports regulated research with schedule I controlled substances, as evidenced by increases proposed for 2022 as compared with aggregate production quotas for these substances in 2021,” the agency said, adding that it working “diligently” to process and approve marijuana manufacturers applications in particular, as there’s currently only one farm at the University of Mississippi that’s permitted to cultivate the plant for research.
“Based on the increase in research and clinical trial applications, DEA has proposed increases in 3,4- Methylenedioxyamphetamine (MDA), 3,4-Methylenedioxymethamphetamine (MDMA), 5-Methoxy-N,N-dimethyltryptamine, Dimethyltryptamine, Lysergic acid diethylamide (LSD), Marihuana, Marihuana Extract, Mescaline, Psilocybin, Psilocyn, and All Other Tetrahydrocannabinols to support manufacturing activities related to the increased level of research and clinical trials with these schedule I controlled substances.”
Here are the exact numbers for the proposed 2021 and 2022 quotas:
|All other tetrahydrocannabinol||1,000||2,000|
A 30-day public comment period will be open after the notice is formally published on Monday.
It’s difficult to overstate just how significant the proposed 2022 increases are, but it’s certainly true that scientific and public interest in marijuana and psychedelics has rapidly increased, with early clinical trials signaling that such substances show significant therapeutic potential.
National Institute on Drug Abuse (NIDA) Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s previous proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.
Advocates and experts remain frustrated that these plants and fungi remain in the strictest federal drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.
A federal appeals court in August dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act. However, one judge did say in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana.
Separately, the Washington State attorney general’s office and lawyers representing cancer patients recently urged a federal appeals panel to push for a DEA policy change to allow people in end-of-life care to access psilocybin under state and federal right-to-try laws.
Image element courtesy of Kristie Gianopulos.
Supreme Court Won’t Hear Case On Legalizing Safe Drug Consumption Sites, But Activists Are Undeterred
The U.S. Supreme Court (SCOTUS) has rejected a request to hear a case on the legality of establishing safe injection sites where people can use illicit drugs in a medically supervised environment.
The justices announced on Tuesday that they decided against taking up the case raised by the nonprofit Safehouse, despite the pleas of attorneys general from 10 states and D.C. who recently filed amici briefs urging the court’s involvement.
Representatives from 14 cities and counties, as well as the mayor of Philadelphia, which is at the center of the current case, also filed briefs in support of the case in recent days.
Safehouse was set to launch a safe consumption site in Philadelphia before being blocked by a legal challenge from the Trump administration. It filed a petition with the nation’s highest court in August to hear the case.
But while the Supreme Court declined to take action—and the Biden administration passed up its voluntary opportunity to weigh in at this stage, which may well have influenced the justices’ decision—activists say the battle will continue at a lower federal court level, where the administration will have to file briefs revealing its position on the issue.
Disappointed but not surprised U.S. Supreme Court declined to hear our case. We’re pursuing our claims in federal court. As that litigation proceeds, Biden administration will have to take a position, which it avoided by waiving its right to respond to our Supreme Court petition.
— Safehouse (@SafehousePhilly) October 13, 2021
“We were disappointed that the government chose not to respond to our petition,” Safehouse Vice President Ronda Goldfein told Filter. “They said, ‘We’re going to waive our right to respond,’ [and] the Supreme Court declined to review our case. Ordinarily that sounds like the end of the road—but in our case we are still pursuing our claims in a different venue.”
That venue will be the the federal district court in Philadelphia, where activists plan to submit multiple arguments related to religious freedom and interstate commerce protections. The Biden administration will be compelled to file a response in that court by November 5.
“If they don’t respond, they lose,” Goldfein said.
A coalition of 80 current and former prosecutors and law enforcement officials—including one who is President Joe Biden’s pick for U.S. attorney of Massachusetts—previously filed a brief urging the Supreme Court to take up Safehouse’s safe injection case.
Fair and Justice Prosecution, the group that coordinated the amicus brief, also organized a tour of Portugal for 20 top prosecutors in 2019 so they could learn about the successful implementation of the country’s drug decriminalization law.
If the Supreme Court were to have taken the case and rule in favor of Safehouse, it could have emboldened advocates and lawmakers across the country to pursue the harm reduction policy.
The governor of Rhode Island signed a bill in July to establish a safe consumption site pilot program where people could test and use currently illicit drugs in a medically supervised environment. It became the first state in the country to legalize the harm reduction centers. It’s not clear whether the Department of Justice will seek to intervene to prevent the opening of such facilities in that state.
Massachusetts lawmakers advanced similar legislation last year, but it was not ultimately enacted.
A similar harm reduction bill in California, sponsored by Sen. Scott Wiener (D), was approved in the state Senate in April, but further action has been delayed until 2022.