USDA Approves Genetically Modified Hemp That Produces No THC Or CBD

The U.S. Department of Agriculture (USDA) says a genetically modified version of hemp produced by researchers in Wisconsin “may be safely grown and bred in the United States” and is “unlikely to pose an increased plant pest risk compared to other cultivated plants.”

The hemp variety, dubbed “Badger G,” does not produce THC or CBD but is designed to have higher levels of the cannabinoid CBG. It’s at least the second type of genetically modified hemp to get the OK from APHIS after another modified plant, which produces lower levels of THC and CBC, was approved in October.

USDA’s Animal and Plant Health Inspection Service (APHIS) said on Wednesday that the modified hemp, along with five other unrelated engineered plant varieties, “are not subject to regulation under 7 CFR part 340,” which regulates the movement of genetically modified organisms (GMO).

Then genetically modified hemp variety was developed by the University of Wisconsin’s Crop Innovation Center. In its application for a USDA regulatory status review, the university said Badger G “is absent of CBD/CBDA and THC/THCA through a gene editing knockout of the endogenous CBDAS gene.”

Eliminating that gene, says the application from senior scientist Michael Petersen, “will provide U.S. growers with agronomic and compliance benefits, including higher levels of the cannabinoid CBG/CBGA and elimination of THC/THCA.”

“Approximately 25% of the hemp crop in the US is discarded due to THC/THCA levels beyond the 0.3% threshold set forth in the 2018 Farm Bill,” it continues. “Our new line will allow farmers to be in full compliance with these regulations.”

In response to the request, APHIS wrote that it “determined your C. sativa is unlikely to pose an increased plant pest risk relative to comparator C. sativa plants.” Such a determination, it explained, means the agency “has no authority to regulate” Badger G under GMO regulations, nor are crosses between the modified hemp plant and natural hemp plants.

“Please be advised that APHIS’ decision applies to the C. sativa developed using genetic engineering exactly as described in your letter,” the response says. “If at any time you become aware of any information that may affect our review of your modified C. sativa, including, for example, new information that shows the trait, phenotype, or mechanism of action is different than described in your letter, you must contact APHIS for further review of the plant.”

USDA has been attempting to work more closely with hemp growers and breeders since the crop was legalized through the 2018 Farm Bill. Last year, the department released updated guidance on how to identify, describe and evaluate different varieties of the plant.

Earlier this month, USDA issued a new “Hemp Research Needs Roadmap” divided into four areas: Breeding and Genetics, Best Practices for Production, Biomanufacturing for End Uses and Transparency and Consistency. The document “reflects stakeholder input in identifying the hemp industry’s greatest research needs,” USDA said in a press release.

USDA announced the report and new research funding on what the department said was the country’s second National Biobased Products Day, “a celebration to raise public awareness of biobased products, their benefits and their contributions to the U.S. economy and rural communities.”

While much of the document is a survey of research goals around hemp, it also includes a proposal to develop a public-private “hemp consortium,” saying that collaboration is “critical to ensuring value along the entire hemp supply chain.”

Amid state-level legalization of marijuana and the federal government’s legalization of low-THC hemp and its derivative products, interest in research around hemp industry and commerce has ballooned in recent years.

Last month new federally funded research into how to distinguish hemp and marijuana in order to assist crime labs identified two new methods for differentiating the two forms of cannabis.

U.S. Customs and Border Protection (CBP) also put out a solicitation in 2022, seeking portable marijuana analyzers to quickly identify cannabinoid profiles and help distinguish between marijuana and hemp.

And in 2019, the Drug Enforcement Administration (DEA) separately announced that it was seeking a device to “provide specificity to distinguish between hemp and marijuana” since the former crop was legalized.

USDA has also sent out thousands of surveys to hemp farmers, meant to understand how the industry is growing but also identify challenges in business and regulation. The department launched its first annual survey in 2021, and it updated the questionnaire last year before distributing it to farmers and releasing a report with findings that showed significant declines in the value and production of the crop in 2022.

The Food and Drug Administration (FDA), for its part, is considering a proposal to allow hemp seed meal as livestock for hens.

Meanwhile, USDA has been reportedly revoking hemp licenses for farmers who are simultaneously growing marijuana under state-approved programs, underscoring yet another policy conflict stemming from the ongoing federal prohibition of some forms of the cannabis plant.

Federal hemp rules could be further amended as part of the next iteration of large-scale agriculture legislation. The 2018 Farm Bill that legalized the crop was supposed to be updated last year, but it’s been extended through much of 2024.

Earlier this week, 21 attorneys general urged congressional leaders to take action on intoxicating hemp products that became legal through the 2018 change. Federal lawmakers should amend the definition of hemp, they wrote, and clarify that states can take their own measures to regulate the plant and its derivative products.

“As Congress prepares to embark on a new five-year reauthorization of the Farm Bill, we strongly urge your committees to address the glaring vagueness created in the 2018 Farm Bill that has led to the proliferation of intoxicating hemp products across the nation and challenges to the ability for states and localities to respond to the resulting health and safety crisis,” the top state law enforcement officials wrote. “We urge Congress in the strongest possible terms to address this reckless policy.”

Lawmakers and stakeholders are eyeing a number of other proposals that could be incorporated in the new farm bill, including measures to free up hemp businesses to legally market products like CBD as dietary supplements or in the food supply and to remove restrictions on participation in the industry by people with certain prior drug convictions.

FDA has regulatory jurisdiction over that issue, but at the beginning of last year, the agency said it didn’t have a pathway to make it happen and instead offered to work with Congress on a solution.

In response, Sens. Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer (D-OR), filed legislation last July that would remove regulatory barriers that FDA claims prevents it from allowing CBD marketing.

Congressional researchers cautioned last November that varying policy priorities among industry stakeholders could make the task of updating the federal farm bill more difficult.

The CRS report also referenced several recent hemp bills that federal lawmakers may consider folding in to the broader agricultural legislation.

One bipartisan bill filed last March seeks to end what critics say is a “discriminatory” federal policy that bars people with prior felony drug convictions from owning or leading legal hemp businesses. Another bipartisan measure would reduce regulations on farmers that grow industrial hemp for non-extraction purposes.

For the time being, the hemp industry continues to face unique regulatory hurdles that businesses have blamed for the crop’s value plummeting in the short years since its legalization. Despite the economic conditions, however, a recent report found that the hemp market in 2022 was larger than all state marijuana markets, and it roughly equaled sales for craft beer nationally.

Meanwhile, internally at USDA, food safety workers have been encouraged to exercise caution and avoid cannabis products, including federally legal CBD, as the agency observes an “uptick” in positive THC tests amid “confusion” as more states enact legalization.

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