Research Policy Analysis and Coordination
Regulatory and Statutory Background
Industrial hemp is a variety of the Cannabis sativa L. plant that contains no more than 0.3 percent concentration (on a dry weight basis) of the psychoactive compound delta-9-tetrahydrocannabinol (THC). Traditionally, industrial hemp has been used for manufacturing purposes rather than any psychoactive or therapeutic effects.
In December 2018, Congress passed the Agricultural Improvement Act of 2018 (commonly known as the 2018 Farm Bill), legalizing hemp production pursuant to United States Department of Agriculture (USDA) regulations. Prior to the 2018 Farm Bill, industrial hemp was included within the federal Controlled Substances Act definition of marijuana as a Schedule I drug and under the purview of the Drug Enforcement Administration (DEA). The 2018 Farm Bill amended the federal Controlled Substances Act to exclude hemp and hemp derivatives from the definition of marijuana. Thus, industrial hemp is no longer a Schedule I Controlled Substance. Nevertheless, hemp research must be conducted in compliance with both federal and State of California law and regulations.
Applicable federal law currently includes the 2014 Farm Bill (which, under Section 7606, allows research cultivation of hemp by a state Department of Agriculture that has established a research Pilot Program or a University), the 2018 Farm Bill (which allows for hemp cultivation pursuant to USDA regulations), FDA regulations (applicable to products intended for human or animal consumption and to interstate commerce of such products) and USDA regulations. Note that Section 7606 of the 2014 Farm Bill will be repealed one year after the date on which USDA establishes a plan to monitor and regulate hemp production under Section 297C of the Agricultural Marketing Act of 1946. Once Section 7606 is repealed, university production of hemp will be governed by the 2018 Farm Bill.
Specific to USDA regulations, hemp may only be cultivated by entities operating in a state that has received USDA approval for its state plan, or, in the absence of such a state plan, by a grower that has applied for and obtained a license directly from the federal USDA. As of the publishing of this Guidance memo, the USDA has not yet promulgated regulations for industrial hemp production nor approved state regulatory plans or licenses. This means that there are several remaining implementation issues, which will require further Federal and State rulemaking or guidance. In addition to USDA, the 2018 Farm Bill explicitly preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds as a drug subject to FDA oversight.
Applicable State law can be found in Division 24 of the state Food and Agricultural Code, which, though it exempts Established Agricultural Research Institutions (like UC) from many of the requirements that apply to commercial hemp growers, does set out requirements that apply to research institutions, as discussed below. California is still developing regulations and policies that apply to hemp cultivation in the state, and is providing updates through CDFA’s webpage.
Please review these Frequently Asked Questions on requirements for conducting research with hemp and hemp derivatives, and for cultivating industrial hemp for research purposes.