Federal efforts to reschedule cannabis typically are framed as a matter of drug policy. The debate centers on issues such taxation, criminal enforcement, and whether cannabis should remain grouped with substances like heroin and LSD under the Controlled Substances Act (CSA).
Yet this framing increasingly obscures a deeper regulatory transformation already underway: Federal rescheduling could significantly expand the legal space for cannabis genetics research, potentially accelerating the development of engineered cannabis varieties and raising the possibility that cannabis regulation could move into the same legal territory that governs genetically engineered crops. Increasingly, cannabis is being explored as a platform crop for plant biotechnology innovation, with researchers applying the same genetic engineering tools used in major agricultural crops. As this transformation continues, the regulatory questions surrounding cannabis increasingly resemble, or at least overlap with, those governing other genetically engineered crops rather than those associated with conventional narcotics regulation.
Federal cannabis rescheduling may therefore represent not merely a shift in drug policy, but the beginning of a broader transition in which cannabis becomes regulated as both a controlled substance and an agricultural biotechnology product.
- The shift to Schedule III: Moving cannabis from Schedule I under the Controlled Substances Act (CSA) dramatically lowers the administrative, licensing, and security barriers that historically choked academic and commercial plant research.
- The CRISPR revolution: Unshackled from stringent Schedule I restrictions, researchers are rapidly deploying advanced tools like CRISPR gene editing and metabolic pathway modification to engineer custom cannabinoid profiles and disease-resistant cultivars.
- The SECURE rule vacatur: In December 2024, a federal court vacated the USDA’s 2020 SECURE rule. This decision dismantled an updated, risk-based exemption system for gene-edited plants, unexpectedly reverting federal biotechnology oversight to an older, more restrictive process-based framework.
- A regulatory collision: As advanced cannabis innovations accelerate, they will hit an unsettled agricultural landscape. Regulators will soon have to navigate an unprecedented overlap: governing cannabis not just as a controlled drug under the CSA, but as a genetically modified crop subject to USDA plant pest risk oversight.
The current status of federal cannabis rescheduling
Under the CSA, controlled substances are placed into one of five schedules based on medical utility, abuse potential, and safety under medical supervision. Schedule I substances — deemed to have a high potential for abuse and no currently accepted medical use — include drugs such as heroin, LSD, and methylenedioxymethamphetamine (MDMA), while Schedule III substances include drugs such as ketamine, anabolic steroids, and certain codeine-containing medications. Cannabis has been classified as a Schedule I substance since the CSA’s enactment in 1970, but this longstanding classification is now under formal federal reconsideration.
Beginning in October 2022, President Joe Biden directed the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) to review cannabis’ classification under the CSA. In August 2023, HHS concluded that cannabis has accepted medical use and a lower potential for abuse than substances classified in Schedule I. In May 2024, the Department of Justice (DOJ) issued a Notice of Proposed Rulemaking to transfer cannabis to Schedule III, initiating the formal rulemaking process under the Administrative Procedure Act (APA). The public comment period closed in July 2024 after receiving approximately 43,000 submissions, one of the largest responses to a DEA rulemaking in history.
Administrative proceedings began later that year but were stayed in January 2025 due to procedural disputes and allegations of agency bias. The proceedings have remained paused while these disputes are resolved. However, on December 18, 2025, President Donald Trump signed Executive Order 14370, entitled “Increasing Medical Marijuana and Cannabidiol Research,” directing the Attorney General to complete the rescheduling rulemaking “as expeditiously as possible.” The order did not itself reschedule cannabis; rather, it revived a stalled administrative process.
In April 2026, Acting Attorney General Todd Blanche signed a final order reclassifying to Schedule III cannabis products approved by the Food and Drug Administration and medical cannabis products grown, manufactured, and sold by state-licensed entities. As of May 2026, adult-use cannabis remains classified as a Schedule I controlled substance. No final rule has been issued, and administrative hearings and anticipated litigation remain potential obstacles to implementation.
Cannabis is entering the biotechnology era
While the legal debate over cannabis rescheduling has largely focused on drug scheduling categories, technological developments in cannabis research suggest the crop is entering a different regulatory domain: agricultural biotechnology. How cannabis is scheduled under federal law likely will shape the regulatory framework governing research on the plant, including the degree to which universities, biotechnology companies, and agricultural researchers may study, breed, and genetically modify cannabis without the heightened controls associated with Schedule I substances.
From cultivation to CRISPR: the tech driving the wave
Researchers increasingly are using tools such as CRISPR gene editing, terpene pathway engineering, and metabolic pathway modification to create cannabis varieties with highly specific characteristics. These technologies allow scientists to alter cannabinoid ratios, modify terpene profiles, enhance resistance to pathogens, improve cultivation efficiency, and stabilize chemical outputs that historically varied widely between plants. Biotechnology companies are also developing methods to produce cannabinoids in alternative biological systems: Engineered yeast and microbial platforms are being used to synthesize cannabinoids outside the plant entirely, which may enable pharmaceutical-scale cannabinoid production independent of agricultural cultivation.
Breaking the Schedule I research bottleneck
Historically, federal prohibition severely constrained these lines of research, because cannabis’s classification as a Schedule I substance under the CSA imposed stringent registration, security, sourcing, and recordkeeping requirements on researchers, limited access to federally authorized research material, and discouraged universities, biotechnology firms, and funding agencies from pursuing cannabis-related projects. These restrictions significantly increased the cost and administrative burden of conducting cannabis research and created practical barriers to experimentation with plant genetics, cannabinoid biosynthesis, and related biotechnology applications.
For example, under current Schedule I status, researchers are required to obtain specialized DEA registrations, impose strict security and sourcing protocols, and limit the number of authorized research suppliers. These constraints have tended to slow academic and commercial research involving cannabis genetics. Additionally, Schedule I classification has been understood to impose strict licensing requirements on scientists and limit the availability of legally authorized research material.
If cannabis is moved to Schedule III, many of these restrictions would be reduced. Schedule III substances remain controlled, but they are subject to generally less burdensome research requirements, allowing registered researchers to obtain, store, and study the substance with fewer administrative barriers and with access to a broader range of lawful sources. Researchers no longer would need the specialized Schedule I research registration, research institutions could access cannabis material more readily, and biotechnology firms would face fewer barriers to experimenting with cannabis genetics. The practical effect likely would include increased levels of cannabis-focused plant biotechnology research, particularly in areas such as cannabinoid biosynthesis engineering, terpene pathway manipulation, and disease-resistant cannabis cultivars.
As cannabis research expands, the plant may increasingly resemble other biotechnology crops that are subject to federal agricultural regulation. This shift carries a practical consequence: cannabis may no longer fit cleanly within a purely drug-control paradigm, and aspects of its oversight may begin to intersect with regulatory regimes governing genetically engineered plants.
The regulatory landscape for biotechnology crops
Advances in cannabis biotechnology may force regulators to confront a new question: Should cannabis continue to be governed primarily as a controlled substance, or should aspects of its oversight begin to resemble the regulatory framework applied to genetically engineered agricultural crops? In practice, these frameworks are not mutually exclusive, and cannabis could remain subject to the CSA while also falling within aspects of federal agricultural oversight depending on the nature of the modification. In addition, certain cannabis-derived products may implicate FDA regulatory frameworks, further complicating the emerging oversight landscape. In particular, genetically engineered cannabis plants may raise questions about whether federal oversight should extend beyond the CSA to the regulatory frameworks that govern engineered agricultural plants.
In the United States, genetically engineered plants are primarily regulated under the Plant Protection Act (PPA) through the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS). The PPA authorizes the USDA to regulate organisms that may pose a plant pest risk, meaning organisms that could injure, damage, or cause disease in agricultural plants. Although the statute was not originally written with modern genetic engineering in mind, it became the principal legal framework through which the federal government oversees genetically modified crops.
For decades, USDA’s regulatory approach was largely process-based. Federal oversight depended primarily on whether the engineering process involved plant pest organisms or plant pest DNA, such as genetic material introduced through Agrobacterium tumefaciens, a bacterium widely used in early plant transformation techniques. If plant pest DNA was used in the transformation process, the resulting plant typically fell under APHIS jurisdiction and required permits or regulatory review before field testing or commercialization.
This regulatory framework increasingly came under criticism as plant biotechnology advanced. By the early 2000s, researchers had begun developing genetic engineering methods that did not rely on plant pest organisms in the same way. The emergence of gene-editing technologies such as CRISPR further exposed the limitations of the older regulatory model. Under a purely process-based framework, plants with small, targeted edits could trigger regulatory oversight while other plants with similar genetic changes produced through conventional breeding could avoid regulation entirely.
These tensions prompted the USDA to undertake a long-running effort to modernize its biotechnology regulations. Beginning in the mid-2000s, APHIS initiated multiple rulemaking proposals and requests for comment aimed at transitioning toward a regulatory system focused more directly on the risk characteristics of the resulting plant rather than the engineering technique used to produce it.
The rise and fall of the USDA’s SECURE rule
That effort culminated in 2020 with the finalization of the USDA’s Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule. The rule represented the most significant update to federal biotechnology regulation in decades. Instead of automatically regulating plants based on the presence of plant pest DNA, the SECURE Rule directed APHIS to evaluate whether a genetically engineered plant posed a plausible plant pest risk under the statutory authority of the Plant Protection Act.
The rule also introduced automatic exemptions for certain gene-edited plants, particularly those that contained genetic changes indistinguishable from mutations that could occur naturally or through conventional breeding. This framework was designed, in part, to accommodate emerging gene-editing technologies that allow researchers to make precise modifications to plant genomes without introducing foreign DNA.
During the four years following the rule’s implementation, more than 200 biotechnology crops passed through the SECURE-defined regulatory process. The rule was described by some commentators as a significant modernization of federal oversight. By reducing certain regulatory barriers for low-risk genetic modifications, the SECURE Rule was intended to facilitate participation for universities, startups, and smaller biotechnology firms in plant innovation activities.
Yet, shortly after it was finalized, advocacy organizations, including the Center for Food Safety, filed suit in federal court. The plaintiffs argued that USDA had unlawfully narrowed its regulatory oversight by exempting certain genetically engineered plants from review. They further contended that APHIS had failed to adequately address its statutory obligations not only to regulate plant pests but also to consider potential noxious weed risks under the PPA.
As a result, in December 2024, the district court vacated the SECURE Rule in its entirety. The court concluded that aspects of the rule were arbitrary and capricious under the APA, finding that APHIS had not sufficiently explained its decision to exempt certain categories of genetically engineered plants from regulatory oversight. The court also determined that USDA had inadequately addressed whether the rule sufficiently considered potential risks associated with noxious weeds.
Because the court vacated the rule rather than remanding it for revision, the regulatory framework governing biotechnology crops has mostly reverted to the pre-2020 system, in which regulatory oversight depends largely on whether plants contain plant pest DNA introduced through genetic engineering techniques.
Cannabis and the SECURE vacatur
The SECURE Rule’s vacatur carries a less obvious implication for cannabis and underscores that the federal regulatory framework governing engineered plants remains unsettled at precisely the moment when cannabis biotechnology is expected to continue advancing. With cannabis’s move from Schedule I to Schedule III, the easing of federal research restrictions likely will reduce barriers to entry for cannabis genetics research. As a result, genetically engineered cannabis varieties developed through CRISPR and related techniques, could emerge more rapidly, potentially outpacing aspects of the existing regulatory framework.
The result is a potential regulatory collision. Cannabis plants engineered to modify cannabinoid biosynthesis, terpene production, or agronomic traits could resemble the types of genetically engineered crops historically reviewed by USDA under the PPA. Yet cannabis remains regulated primarily through the CSA, a framework designed for narcotics control rather than agricultural biotechnology. The vacatur of the SECURE Rule illustrates how unsettled the federal oversight of engineered crops remains. As cannabis rescheduling lowers barriers to genetic research, regulators may more frequently face the question of how, and whether, engineered cannabis plants should be integrated into the broader federal biotechnology regulatory system.
Whether such cannabis innovations would fall within USDA jurisdiction remains uncertain, but the possibility is increasingly real. If cannabis plants are engineered using techniques that incorporate plant pest DNA, such as Agrobacterium-mediated transformation, APHIS plausibly could assert jurisdiction under the PPA. Even gene-edited cannabis plants that do not involve plant pest organisms could trigger regulatory scrutiny as federal regulators reassess how engineered crops should be governed. Much will depend on the techniques used to engineer the plants and whether the resulting modifications involve plant pest DNA or present a plausible plant pest risk. Yet as cannabis biotechnology expands, federal regulators may increasingly confront the question of whether cannabis should be regulated solely through the CSA or whether it also should be treated as an agricultural biotechnology crop within the broader federal framework governing engineered plants, although in practice overlapping regulatory approaches may emerge.
Jacob Golan, PhD, is an associate attorney at Day Pitney LLP who focuses on intellectual property law with particular experience in biotechnology, bioinformatics, artificial intelligence, medical device innovations, agrotechnology, and material science. He holds a PhD in microbiology from the University of Wisconsin–Madison, where he received training in genomics, computational biology and biophysics.
James Leva is a labor and employment partner at Day Pitney who regularly defends employers against all types of employment-related claims, including discrimination, harassment, whistleblower and retaliation. He also chairs the firm’s cannabis practice. In that capacity, he advises employers regarding the ever-changing federal and state medicinal and recreational cannabis laws impacting the workplace, including policy considerations, drafting, and implementation.
Richard Emmons, PhD, co-leads Day Pitney’s patent prosecution and counseling practice group, where he provides strategic patent guidance, global portfolio development, and investment-focused intellectual property advisory to life sciences, med-tech, and deep-tech innovators. With a PhD in Developmental Biology from Washington University School of Medicine and postdoctoral training at Harvard Medical School, Emmons brings deep expertise across bioinformatics, genetics, immunology, molecular and cell biology, and translational medicine.
