September 23, 2021

Volume XI, Number 266

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September 23, 2021

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September 22, 2021

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September 21, 2021

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USDA Publishes Final Rule for the Domestic Hemp Production Program

On January 19, 2021, USDA published a final rule that provides regulations for the production of hemp in the United States. The final rule builds on the interim final rule that established the U.S. Domestic Hemp Production Program, which was published on October 31, 2019. We previously discussed the interim final rule here. The final rule incorporates modifications based on public comments and lessons learned during the 2020 growing season.

A few of the key provisions of the final rule include:

  • Producers must dispose of plants that exceed the acceptable hemp THC limit (not more than 0.3%). The final rule raises the negligent threshold from 0.5% to 1% and limits the number of negligent violations that a producer can receive in a growing season to one. If the plants test at or below the negligent threshold, the producer will not be considered to be in violation.

  • The final rule allows for alternative disposal methods for non-compliant plants that do not require using a DEA reverse distributor or law enforcement.

  • DEA has extended enforcement flexibility to allow non-DEA registered labs to test hemp until January 1, 2022 due to an insufficient number of DEA-registered labs. DEA is continuing to process lab registration applications.

  • The timing of sample collection has been extended from a 15-day window to 30 days before harvest.

  • The final rule allows states and tribes to adopt a performance-based approach to sampling and must submit their plan to USDA for approval.

  • The final rule states that a tribe may exercise jurisdiction over the production of hemp across its territory regardless of the extent of its inherent regulatory authority.

The final rule becomes effective on March 22, 2021.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 20
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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