Complex Hemp Processes Need Nimble Regulatory Approach

• Published date: 10 August 2023
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Cannabis & Hemp, Food and Drugs Law
• Law Firm: Arnold & Porter
• Author: Mr David Kouba

The 2018 Farm Bill¹ legalized hemp and products derived from hemp so long as they contain less than 0.3% Delta-9 THC.

On the surface, this 0.3% limit seems simple. But cannabis and cannabis products take many forms. And the processes that grow seeds into plants, convert plants into in-process extracts and derivatives, and incorporate those in-process materials into end products are multifaceted and complex.

As a result, the 0.3% standard has presented, and continues to present, different issues at the time of harvest, during processing and when products enter commerce.

The following discusses each stage, the issues they raise, and potential legal approaches that embrace flexibility, continued adjustment and reasonableness.

The 2023 Farm Bill, likely to be deliberated later this year, presents an opportunity for Congress to address these issues.

THC Limits at the Time of Harvest

The 2018 Farm Bill amended the Controlled Substances Act's definition of "marihuana" to exclude both hemp plants and

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.²

Congress defined "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.³

It further directed the U.S. Department of Agriculture to enact regulations to ensure compliance with this standard.⁴

The USDA subsequently enacted regulations that, among other things, require that the Delta-9 content in cannabis be tested no more than 30 days before harvest and set forth how those tests should take place.⁵

The regulations further describe the permissible range of results that will satisfy the 0.3% standard.[6] If THC content falls within that range, the cannabis qualifies as hemp under the statute at the time of harvest.

When applied to plants at the time of harvest, the 0.3% limit has raised criticism. One significant concern is that the standard is too low and harms hemp farmers.

According to a Congressional Research Service report, the USDA estimates that around 20% of hemp plants each year exceed the limit ' and must be destroyed ' often for reasons beyond a farmer's control, such as weather.⁷

The same report notes that some farmer and hemp advocacy groups have advocated for raising the limit on THC content for hemp plants to "provide flexibility to growers and avoid crop destruction."⁸

Congress, it appears, might answer those calls in the near future and increase the current 0.3% standard that applies to hemp in the field.⁹

Last year, for example, Rep. Chellie Pingree, D-Maine, introduced the Hemp Advancement Act that included a 1.0% limit at the time of harvest.¹⁰ The limit, however, would apply not only to Delta-9; it would limit the total THC concentration, which would include the aggregate concentration...