By Joseph R. Englander
As published in the Daily Business Review on October 31, 2019
On Oct. 29, the U.S. Department of Agriculture (USDA) released draft interim rules for hemp production. These rules on hemp will be formally published in the Federal Register on Oct. 31. With the formal publication of the interim rules, the USDA begins its implementation of the federal hemp program. A 60-day public comment period follows the formal publication.
The interim rules include provisions for the USDA to approve plans submitted by states and Indian Tribes for the domestic production of hemp. State or Tribal plans must be submitted to the USDA and approved prior to their implementation. The draft rules also establish a federal plan for producers in states or territories of Indian Tribes that do not have their own USDA-approved plan. Florida’s current plan, the framework of rules being promulgated by the Florida Department of Agriculture and Consumer Services (FDACS), is also at the public comment stage which concludes at the end of October. FDACS had the foresight to draft application forms that require information from applicants that is also required in the draft USDA rules.
Importantly, the USDA decided it will not include a seed certification program in the rule. One cited reason is that the same seeds grown in different geographical locations and growing conditions can react differently. Another reason is that the USDA does not have accurate data currently on the origin of most hemp seed planted in the United States.
The USDA interim rule also includes sampling regulations. For example, within 15 days prior to the anticipated harvest of cannabis plants, designated individuals will obtain samples from the flower material from the cannabis plants for delta-9 tetrahydrocannabinol concentration level testing. The USDA is still requesting comments and information regarding this 15-day sampling and harvest timeline.
If it stands, this provision may require a tweak to the FDACS regulations as currently drafted. The FDACS final rule on sampling currently states that a sample must be collected and submitted in accordance with the hemp field sampling manual for licensees found on the FDACS website. This manual currently states that a sample must be collected no earlier than 30 days before harvest. However, the 30-day provision should still stand for hemp that is not grown for flower material, e.g., seeds.
Under the new rules, laboratories conducting hemp testing must be registered by the Drug Enforcement Agency (DEA). However, USDA approval may in the future be required on top of DEA registration.
Importantly, the USDA interim rules include a provision for measurement of THC that is accompanied by a quantitative statement of its uncertainty, or margin of error. When a quantity is measured, the outcome depends on several factors, such as the accuracy of the measuring device or the skill of the operator. It is normally expressed as +/- with a number, (e.g., +/- 0.5). With inherent uncertainty in mind, the interim rule includes a definition of “acceptable hemp THC level” to account for the uncertainty in the test results. Because of the potential error, a reported THC concentration level of a sample may not be the actual concentration level in the sample. However, the actual THC concentration level would be within the given margin of error for the reported concentration level.
This provision will help producers. Consideration of the margin of error in current testing procedures will allow crops that might otherwise fail for having high THC to be properly harvested as hemp. Thus, the USDA’s consideration of uncertainty will actually reduce uncertainty for hemp growers.
Joseph R. Englander is a shareholder in the intellectual property practice group at Fowler White Burnett, where he leads the firm’s cannabis law team working with industry clients in the field of hemp, medical marijuana and affiliated businesses. Contact him at jenglander@fowler-white.com.