On January 19, 2021, the USDA will issue the first federal final agency regulation governing hemp production. A sneak peek of the Agricultural Marketing Service (AMS) rule is available here. The final rule will become effective on March 22, 2021.
Notable Provisions
DEA Registration for Testing Laboratories Required for All Labs Testing Hemp (Even Unofficial Samples Throughout the Growing Season)
- This requirement remains in the final rule
- Given the limited number of DEA-registered labs currently, enforcement of this requirement will continue to be delayed until December 31, 2022
- AMS acknowledged it received comments in opposition to this requirement, but it retains the requirement that any lab testing hemp for regulatory compliance purposes must be registered with the DEA to conduct chemical analysis of controlled substances per 21 CFR 1301.13
- DEA registration also applies to any lab testing hemp throughout the growing season to informally monitor THC concentration
- AMS justifies this requirement by saying: “Registration is necessary because laboratories could potentially handle cannabis that tests above 0.3 percent THC on a dry weight basis, which is, by definition, marijuana and a Schedule 1 controlled substance”
Laboratory Accreditation Not Required
- AMS will not provide an AMS administered lab approval program or require ISO 17025 accreditation
Testing for Total THC Required
- AMS will retain the requirement test for “total” THC instead of only “delta-9” THC
Harvest Window Expanded
- AMS is expanding the post-sampling hemp harvest window from 15 days to 30 days
Performance-based Sampling Permitted
- USDA will allow States and Indian Tribes to consider performance-based alternatives when developing sampling plans
Where to Take Samples from the Plant
- AMS retains the requirement that pre-harvest samples be taken from the flower material of hemp plants
- The final rule clarifies the number of inches of plant material needed for the sample and provides greater detail as to where exactly on the plant to make a cutting
Designated Sampling Agents
- AMS is retaining the requirement that only designated agents can collect samples
- A Federal, State, Local, or Tribal law enforcement agency or other Federal, State, or Tribal designated person may collect hemp samples to test THC levels in hemp
Disposal of Non-compliant Plants Still Required, but With More Flexible Options
- The disposal requirements remain the same, but “disposal” is clarified and remediation is an option to remove non-compliant plants
- Some of these new options for disposal include, but are not limited to, plowing under, composting into “green manure” for use on the same land, tilling, disking, burial, or burning
- Remediation can occur by removing and destroying flower material while retaining stalk, stems, leaf material, and seeds, or by shredding the entire plant into a biomass-like material, then re-testing the shredded biomass material for compliance
Negligence Standard Increased to 1%
- The negligence threshold increased from 0.5 to 1.0 percent THC
- The rule clarifies how States and Indian Tribes determine when to suspend or revoke a producer’s license
While it will take time to digest the content and fully appreciate the implications, we want share some to highlights provided by Vicente Sederberg, LLP. Please reach out to their hemp team to discuss the USDA Final Rule.