DEA’s Blocking of Imported Viable Hemp Seeds
In response to the enactment of the 2014 farm bill provision allowing for the cultivation of industrial hemp by research institutions and state departments of agriculture, several states made immediate plans to initiate new hemp pilot projects.
Kentucky announced plans for several pilot projects through the Kentucky Department of Agriculture. However, in May 2014, U.S. Customs officials blocked the department’s shipment of 250 pounds of imported viable hemp seed from Italy at Louisville International Airport. DEA officials contend that the action was warranted since the “importation of cannabis seeds continues to be subject to the Controlled Substances Import and Export Act (CSIEA)”96 and to the implementing regulations, which restrict persons from importing viable cannabis seed unless they are registered with DEA and have obtained the necessary Schedule I research permit, among other requirements.
Viable seeds are seeds that are alive and have the potential to germinate and develop into normal reproductively mature plants, under appropriate growing conditions. DEA has required that seeds be either heat sterilized or steam sterilized to remove any naturally occurring traces of THC, which makes the seeds mostly incapable of germination. DEA regulates the importation, sterilization, and commercial distribution of hemp seed pursuant to CSIEA.97
To facilitate release of the hemp seeds, the Kentucky Department of Agriculture filed a lawsuit in U.S. District Court against DEA, DOJ, U.S. Customs and Border Protection, and the U.S. Attorney General.98 In the lawsuit, the department contends that its efforts to grow industrial hemp are authorized under both state and federal law and that DEA should not seek to impose “additional requirements, restrictions, and prohibitions” on hemp production beyond requirements in the 2014 farm bill or otherwise interfere with its delivery of hemp seeds.
Although Kentucky’s seeds were eventually released and planted, these circumstances have resulted in uncertainty for U.S. hemp growers. Some in the industry claim that DEA continues to initiate policy changes intentionally to block hemp cultivation.99 In response, Congress enacted additional legislation to stop DEA from “Selected Appropriations Actions”.
Dispute Over Hemp Food Shipments
In January 2017, HIA petitioned the U.S. Court of Appeals for the Ninth Circuit to block DEA’s implementation of its December final rule on marijuana extracts, which would designate certain hemp-derived nonpsychotropic products, such as cannabidiol (CBD), as a “marihuana extract” subject to the CSA.100 Then, in February, 2017, HIA again petitioned the court alleging that DEA violated the court’s 2004 order (see discussion in “Dispute over Hemp Food Imports (1999-2004)”) when it indicated that a North Dakota hemp company would need a DEA registration and would be subject to other requirements before it could ship processed hemp products outside the state, even though these products were in accordance with state law and the 2014 farm bill.101
2016 Joint “Statement of Principles” on Industrial Hemp
In August 2016, DEA issued three major decisions on marijuana and industrial hemp.102 Regarding marijuana, DEA announced it was rejecting a petition to reschedule marijuana (affirming its continued status as an illegal Schedule I controlled substance).103 It also announced certain policy changes regarding authorized marijuana cultivators for research.104 Regarding industrial hemp, DEA issued a joint statement with USDA and FDA on the principles on industrial hemp.
The three federal agencies acknowledged that the 2014 farm bill provision regarding industrial hemp “left open many questions regarding the continuing application of Federal drug control statutes to the growth, cultivation, manufacture, and distribution of industrial hemp products, as well as the extent to which growth by private parties and sale of industrial hemp products are permissible.”105 The 2014 farm bill also “did not remove industrial hemp from the controlled substances list.” Federal law continues to restrict hemp-related activities that were not specifically legalized under the farm bill provision, which did not amend CSA requirements regarding the manufacture and distribution of “drug products” containing controlled substances. The farm bill provision also did not amend the Federal Food, Drug, and Cosmetic Act106 regarding the approval process for new drug applications.
The joint statement restates the 2014 farm bill’s requirement that hemp be grown and cultivated “in accordance with an agricultural pilot program … established by a State department of agriculture or State agency … in a State where the production of industrial hemp is otherwise legal under State law.”107 It further notes that “state registration and certification of sites used for growing or cultivating industrial hemp” were not addressed in the 2014 farm bill and recommends that “such registration should include the name of the authorized manufacturer, the period of licensure or other time period during which such person is authorized by the State to manufacture industrial hemp, and the location, including Global Positioning System coordinates, where such person is authorized to manufacture industrial hemp.”
Among the noted positive aspects of the joint statement is clarification by the federal agencies about who is able to grow or cultivate industrial hemp as part of a state’s agricultural research pilot program and the applicability of USDA research and other programs to support industrial hemp. Other aspects of the joint statement, however, have raised concerns regarding how the federal agencies view the statutory definition of industrial hemp and also possible restrictions on the sale of industrial hemp products and the importation of viable seeds for growing and cultivation. Each of these is discussed in the following sections.
Many in Congress and in the industry had much anticipated clarification regarding DEA’s position on industrial hemp by, given continued uncertainty despite support for hemp cultivation in the 2014 farm bill. The joint statement provides guidance to “individuals, institutions, and states” on a number of issues pertaining to the growing and cultivation of industrial hemp. While some in Congress and the U.S. hemp industry are encouraged by parts of the joint statement, they have also expressed concerns about other aspects of the joint statement.108 A summary of these issues is as follows.
Clarification regarding who can grow/cultivate hemp. The joint statement acknowledges that the 2014 farm bill authorized “State departments of agriculture, and persons licensed, registered, or otherwise authorized by them” and “institutions of higher education or persons employed by or under a production contract or lease with them” to grow or cultivate industrial hemp as part of an agricultural pilot program in accordance with the 2014 farm bill. This seemingly clears up confusion regarding the potential participation of private farmers licensed or under contract with authorized state departments of agriculture and institutions of higher learning.
Clarification regarding USDA research support for hemp. The joint statement clarifies that institutions of higher education and other authorized participants “may be able to participate in USDA research or other programs to the extent otherwise eligible for participation in those programs.” This seemingly addresses questions raised in November 2015 by some Members of Congress as part of a letter sent to USDA requesting clarification on the extent to which federal funds may be used to support research on industrial hemp.
Confusion regarding the definition of industrial hemp. Some in the hemp industry worry that the joint statement reinterprets the statutory definition of industrial hemp to cover fiber and seed only, excluding flowering tops, which they believe is covered by the farm bill definition.109 The flowering heads of the plant have the greatest cannabinoid content. They also worry that the joint statement expands upon inherent restrictions to the statutory definition in that it broadly highlights the term THC, which is defined to include “all isomers, acids, salts, and salts of isomers of tetrahydrocannabinols,” whereas the statutory definition in the 2014 farm bill specifies delta-9 THC, the dominant psychoactive cannabinoid of cannabis. Some in Congress claim that the executive branch is defining industrial hemp more narrowly than that defined in statute in that it “drops the ‘delta-9’ when describing tetrahydrocannabinol” and “adds isomers, acids, and salts of isomers of THC to count against the 0.3% THC threshold.”110 These Members of Congress have asked that the definition be removed from the guidance.
Confusion regarding possible restrictions on commerce. Some in Congress note that the 2014 farm bill defined ‘‘agricultural pilot program’’ to mean “a pilot program to study the growth, cultivation, or marketing of industrial hemp” (italics added).111 These Members of Congress have asked for confirmation that “general commercial activity” does not prevent any types of sale from occurring from the framework of an approved pilot program. Likewise, the hemp industry remains concerned about the inclusion of language in the joint statement indicating that “industrial hemp products … may not be sold in States where such sale is prohibited.”112 Broadly speaking “industrial hemp products” are already widely marketed, sold, and distributed. Some claim that this restriction on sales is contrary to provisions in both the CSA and the 2014 farm bill.
Confusion regarding the transportation and sales of hemp. The joint statement also emphasizes that “industrial hemp plants and seeds may not be transported across State lines,” and restates DEA’s position that the importation of viable cannabis seeds be carried out by DEA-registered persons, in accordance with CSIEA, seemingly to limit the sale of hemp products only in states with industrial hemp pilot programs. This remains a contentious issue following DEA’s blocking of viable hemp seed in 2014. Some on Congress maintain that federal agencies do not have the authority to limit hemp sales or prohibit the transport of plants or seed under the 2014 farm bill.113
The joint statement’s guiding principles are provided in the Appendix B.
Additional confusion remains, however, since the joint statement explicitly says it “does not establish any binding legal requirements,” further raising questions about whether guidance in the statement could influence future DEA policies and enforcement action regarding industrial hemp cultivation and marketing.