Last week, the U.S. Department of Agriculture (“USDA”) revealed that it will delay the enforcement requirement of the Drug Enforcement Agency (“DEA”) laboratory certification process and reverse distributor disposal requirements until October 31, 2021, or until the final rule is established, whichever occurs first.
The interim federal rules for hemp production, released in October of 2019, requires DEA registration for all laboratory testing sites analyzing hemp for THC concentration under the U.S. Domestic Hemp Production Program. According to the USDA website, there are just 47 facilities currently registered with the DEA that are certified to conduct these activities.1 After the interim federal rule release, industry participants voiced strong concern - if not downright outrage - for the requirement due to the current lack of labs that qualify under the standards. For the existing DEA-certified labs, many do not have access to industry-standard equipment and do not have the capacity to process the number of samples.
Regarding the disposal of non-compliant hemp following its testing, the interim federal rules state for non-compliant hemp to be disposed of according to the DEA’s guidelines set out in 21 C.F.R. 1317.15. This regulation requires reverse distribution by certified reverse distributors or law enforcement only, ending in the plant’s destruction by an approved method.2 Industry members have criticized the outlined method of disposal, noting that the lack of certified reverse distributors in the U.S. makes compliance extremely difficult and that the required law enforcement supervision of hot hemp crops' destruction would be an absurd waste of agency resources. The firm hopes that USDA might follow Colorado’s lead and utilize the procedures for crop disposal that have proven to work effectively since 2014.
After a few months of industry working to comply with the interim federal rules, USDA determined that there is not sufficient capacity in the U.S. for the testing in certified laboratories and disposal of non-compliant hemp plants. The USDA stated that “one of the top considerations in making these changes was the desire to provide additional options that minimize, to the extent possible the resource impact to state and local law enforcement in handling hemp that is out of compliance.”3
Today, producers are able to test hemp at non-certified laboratories so long as the laboratories engaged in the testing comply with the same standards of performance as outlined within the interim federal rules, including the requirement to test for total THC employing post-decarboxylation or other similarly reliable methods. Producers are able to dispose of hemp utilizing one of the approved USDA disposal methods.4 USDA will continue to conduct random audits of licensees to ensure hemp is being produced in accordance with the interim rules.
While this delay of enforcement is a step in the right direction, USDA is still drafting the final rule, which will determine the agency’s expectations for testing and disposal going forward. We should also note that this reprieve is not permanent and there is a real possibility that these requirements will go back into effect within the next year or so.
We strongly urge industry participants to voice their concerns over these rules, contact their representatives in Congress, and submit comments to USDA to attempt to strike these requirements from the rules permanently. We also urge market participants to voice opposition to the draconian criminal background checks that USDA is requiring. These checks are unnecessary and they prohibit people who have paid their debt to society from participating in a booming industry.
“Hemp Analytical Testing Laboratories” USDA https://www.ams.usda.gov/rules-regulations/hemp/dea-laboratories
21 CFR 990.27
See 1.
“Hemp Disposal Activities” USDA https://www.ams.usda.gov/rules-regulations/hemp/disposal-activities
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Originally published Feb. 28, 2020, at https://therodmanlawgroup.com