The U.S. Department of Agriculture (USDA) announced the final rule the production of hemp in the United States. The final rule incorporates modifications to regulations established under the interim final rule (IFR) published in October 2019. The modifications are based on public comments following the publication of the IFR and lessons learned during the 2020 growing season. The final rule is available for viewing in the Federal Register and will be effective on March 22, 2021.
Sampling Requirements & Methods
The rule required that samples requiring that the sample be taken from approximately 5 to 8 inches from the “main stem,” “terminal bud” or “central cola,” including the leaves and the flowers, of the flowering top of the plants.
It allow states and tribes to adopt a performance-based approach to sampling in their plans. The plan must be submitted to USDA for approval. It may take into consideration state seed certification programs, history of producer compliance and other factors determined by the State or Tribe.
Timing of Sample Collection
The rule states producers and testing agents a 30 days window to collect samples before harvest to get their plants tested for THC.
Negligent Violation Regarding THC Levels
The final rule raises the negligence threshold from THC testing levels from .5 percent (0.5%) to 1 percent (1%) and limits the maximum number of negligent violations that a producer can receive in a growing season (calendar year) to one, which means that farmers have more wiggle room before being considered negligent for producing “hot” hemp. A producer who is getting negligent violations three times (3) in a five-year (5) period will no longer be allowed to produce hemp.
Disposal & Remediation of Non-Compliant Plants (.3% THC and above)
The rule allows for alternative disposal methods for non-compliant plants that do not require using a DEA reverse distributor or law enforcement and expands the disposal and remediation measures available to producers. AMS will provide acceptable remediation techniques in a separate guidance document using common agricultural practices, instead of requiring it to be taken off-site and destroyed under federal drug-disposal guidelines. Hemp Grower Licenses through and/or who are directly managed by the USDA will still be required to have law enforcement or DEA-registered agents destroy hot hemp off-site.
Testing using DEA-Registered Laboratories
The rule states there are an insufficient number of DEA-registered laboratories to test all the anticipated industrial hemp that will be produced in 2020 and possibly 2021. DEA has agreed to extend the enforcement flexibility allowing non-DEA registered labs to test hemp until January 1, 2022 and is processing lab registration applications quickly to get more labs testing hemp DEA-registered.
THC Limit Unchanged
Many hemp farmers, growers, producers and advocates were lobbying for changes to the THC limit to one percent (1%). As the industry continues to wait for guidance from the U.S. Food and Drug Administration will include existing food-safety rules such as traceability requirements. Which means extractors will most likely have to be GMP, short for Good Manufacturing Practice. That’s because U.S. authorities maintain standards rules of GMP depending on the product. It starts by determining if you make: Food, Dietary, Supplements, Cosmetics, and Pharmaceuticals.
U.S. Food and Drug Administration & cGMP Certifications for Hemp Extractors
Which means hemp extractors will most likely have to be cGMP, short for Good Manufacturing Practice. That’s because U.S. authorities maintain standards rules of cGMP depending on the product. It starts by determining if you make: Food, Dietary, Supplements, Cosmetics, and Pharmaceuticals. Notably, the FDA does not set cGMP regulations for tobacco manufacturing. Instead, the agency oversees tobacco and e-cigarette manufacturing through its Center for Tobacco Products.
Hemp cultivators, producers, growers, farmers who don’t perform extraction still have to have good practice guidelines as well called Good Agricultural and Collection Practices, or the “food code” set by the WHO and United Nations. These standards cover basic sanitation protocols and cover things like harvesting, drying and storing plants destined for human consumption which is tandem to cGMP guidelines.