PROPOSED FOOD AND DRUG ADMINISTRATION RULE:

Following the passage of the Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill, the United States Department of Agriculture (USDA) was tasked with developing and implementing regulations to control domestic hemp production. One of the areas of regulation the USDA is required to cover is the testing of domestic hemp to ensure that it is not in-fact “marijuana”. In the interim final rule released by the USDA on October 31, 2019, the USDA described the testing of domestic hemp as, “The total THC, derived from the sum of the THC and THCA content, shall be determined and reported on a dry weight basis.”[1] Additionally, the interim final rule states, “Testing will be conducted using the post-decarboxylation or other similarly reliable methods where the total THC concentration level measured includes the potential to convert delta-9 tetrahydrocannabinolic acid (THCA) into THC.”[2] Moreover, the USDA interim rule states, “The 2018 Farm Bill mandates testing using post-decarboxylation or other similarly reliable methods where the total THC concentration level considers the potential to convert delta-9 tertahydrocannbinolic acid (THC-A) into THC.”[3]

While the USDA interim rules seem overly broad, they are in-fact following what was stated and required in the 2018 Farm Bill.

2018 FARM BILL:

Passed and enacted in 2018, the 2018 Farm Bill de-scheduled hemp and required the USDA implement a domestic hemp production program for States and territories of Indian Tribes. According to Title X, Subtitle G of the 2018 Farm Bill, “hemp” is defined as, “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”[4]

The 2018 Farm Bill divided the domestic hemp production plans into two main groups. One group will be administered by States and Indian Tribes that submit and receive approval of production plans and the other group will be for hemp producers in states that do not submit or receive approval. The latter group will be administered by the USDA.

Within the 2018 Farm Bill, plans submitted by States and Indian Tribes, “shall only be required to include . . . a procedure for testing, using post-decarboxylation or other similarly reliable methods, delta-9 tetrahydrocannabinol concentration levels of hemp produced in the State or territory of the Indian Tribe . . .”[5] Additionally, the Department of Agriculture’s default plan established by the Secretary is required to include, “a procedure for testing, using post-decarboxylation or other similarly reliable methods, delta-9 tertahydrocannabinol concentration levels of hemp produced in the State or territory of the Indian tribe…”[6] Therefore, in the statute, the domestic production plans propagated by the States, Indian Tribes, and the Department of Agriculture all require testing to be based on “post-decarboxylation or other similarly reliable methods…”.

[1] https://www.federalregister.gov/d/2019-23749/p-29

[2] https://www.federalregister.gov/d/2019-23749/p-80

[3] https://www.federalregister.gov/d/2019-23749/p-390

[4] 2018 Farm Bill, Title X, Subtitle G, Section 297A(1).

[5] 2018 Farm Bill, Title X, Subtitle G, Section 297B(a)(2)(A)(ii).

[6] 2018 Farm Bill, Title X, Subtitle G, Section 297C(a)(2)(B).

 

DECARBOXYLATION:

According to Section 990.1 of the interim USDA rules, decarboxylation is, “The removal or elimination of carboxyl group from a molecule or organic compound.”[1] The interim rule defines “Decarboxylated” as, “The completion of the chemical reaction that converts THC-acid (THC-A) into delta-9-THC . . . The decarboxylated value is also calculated using a conversion formula that sums delta-9-THC and eighty-seven and seven tenths (87.7) percent of THC-acid.”[2] An article on Leafly.com explains the importance of decarboxylation by stating that, “THCA is not intoxicating, and must be converted into THC through decarboxylation before any effects can be felt.”[3] Further, the article on Leafly.com states that, “The two main catalysts for decarboxylation to occur are heat and time. Drying and curing cannabis over time will cause a partial decarboxylation to occur.”[4] Therefore, it naturally follows that the USDA would be interested in testing the THC-A level in combination with the delta-9 THC level of hemp.

 

DEFINITION OF “HEMP” AND “MARIJUANA”:

While there may be a compelling argument for testing both the THC-A and delta-9 THC levels in hemp, the official definitions of both “hemp” and “marijuana” do not necessitate the testing of THC-A. Under the Controlled Substance Act (CSA), “marihuana” is defined as, “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.”[5] Additionally, the definition of “marihuana” explicitly excludes,

 

“hemp”, as defined in section 1639o of title 7; or the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

 

21 U.S.C. 802(16)(B).

Title 7, section 1639o defines “hemp” as, “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”[6] (emphasis added).

Despite the 2018 Farm Bill requiring testing to include THC-A as well as delta-9 THC, the legal definition of “hemp” only includes delta-9 THC. Therefore, this difference in defining how to test and define “hemp” leads to incongruence in legislation.

[1] https://www.federalregister.gov/d/2019-23749/p-458

[2] https://www.federalregister.gov/d/2019-23749/p-457

[3] https://www.leafly.com/news/cannabis-101/what-is-decarboxylation

[4] https://www.leafly.com/news/cannabis-101/what-is-decarboxylation

[5] 21 U.S.C. 802(16)(A).

[6] 7 U.S.C. 1639o(1).

EFFECT OF PROPOSED RULE:

The current effect of the proposed interim rule is to narrow the scope of what may be considered hemp under the 2018 Farm Bill. For example, hemp produced and tested to have a delta-9 THC content of 0.25% is legally considered hemp under the definition of the 2018 Farm Bill. However, if that same hemp has a THC-A level of 0.10%, which would equal 0.0877% according to the decarboxylated conversion,[1] then when combined with the delta-9 THC level, as required by the 2018 Farm Bill and the USDA interim rule, the hemp would be considered “marijuana” and must be destroyed by a person authorized under the CSA to handle marijuana.[2] According to the USDA Final interim rule, “Cannabis plants exceeding the acceptable hemp THC level constitute marijuana, a schedule I controlled substance under the Controlled Substance Act (CSA), 21 U.S.C. 801 et seq., and must be disposed of in accordance with the CSA and DEA regulations found at 21 CFR 1317.15.”[3]

[1] https://www.federalregister.gov/d/2019-23749/p-122; https://www.federalregister.gov/d/2019-23749/p-457

[2] https://www.federalregister.gov/d/2019-23749/p-381; https://www.federalregister.gov/d/2019-23749/p-44; https://www.federalregister.gov/d/2019-23749/p-90; https://www.federalregister.gov/d/2019-23749/p-630

[3] https://www.federalregister.gov/d/2019-23749/p-630