USDA Update on the U.S. Domestic Hemp Production Program

On March 8, 2021, the U.S. Department of Agriculture (USDA) announced it had completed its review of the Final Rule establishing the U.S. Domestic Hemp Production Program. The rule, effective as of March 22, 2021, includes provisions for the USDA to approve hemp production plans including requirements for maintaining information on the production methods, THC testing levels, disposal of non-compliant plant material, and licensing requirements.

After the release of the Final Rule, the USDA offered to brief the AOAC INTERNATIONAL Cannabis Analytical Science Program (CASP) community on the development of the Final Rule, differences between the Final Rule and the Interim Final Rule, and the rule’s implications for hemp growers and laboratories.

On July 14, 2021, Bill Richmond, Chief of the USDA Hemp Program, and Kerry Smith, Director of the Laboratory Approval and Testing Division (LATD), joined AOAC for a live webinar. The session kicked off with an overview of the Hemp Production Program, housed in the Agricultural Marketing Service (AMS). AMS provides services related to quality grading and inspection, market news, research and promotion, and commodity purchasing; it does not have a law enforcement capability.

The USDA Hemp Program regulates the production of hemp (cannabis containing 0.3% or less THC content) by state programs, tribal programs, and licensed individual hemp growers. The 2014 Farm Bill established a pilot program for states and institutes of higher education to study hemp production. After the 2018 Farm Bill uncoupled hemp from marijuana and removed it from the Controlled Substances List, the USDA held a variety of public meetings before issuing the Interim Final Rule (IFR), the first draft of national hemp regulations.

The USDA requested public comments and feedback on the IFR, and AOAC served as a resource for the Agency’s process leading to the Final Rule (FR).

The differences between the FR and IFR aim to provide more flexibility and options to hemp producers, and include:

• Increasing the sampling to harvest window from 15 to 30 days
• Increasing the minimum THC content a hemp grower can produce that counts as a “negligent violation” from 0.5% to 1.0%
• Allowing for “hot crops” (cannabis products with over 0.3% THC content) to be remediated rather than just destroyed
• Allowing for university researchers to apply for licensure and not be subject to the same regulations as commercial growers
• Providing for methods of disposing of “hot crops” on-farm
• Providing for “performance-based sampling” to avoid needing to test every hemp crop

Many regulations related to testing and lab requirements did not change from the IFR to the FR, but clarification and explanation were provided:

• Lab quality assurance must ensure the validity and reliability of test results; method selection, validation, and verification must ensure the method is appropriate and the lab can successfully perform the testing.
• Labs must evaluate and report measurement of uncertainty (MU) with test results. Labs should meet the AOAC INTERNATIONAL standard method performance requirements for selecting an appropriate method to determine the MU.
  • MU is typically not standardized, but rather is controlled using test methods controlled by performance standards (e.g., AOAC Standard Method Performance Requirements 2019.003)
• After December 31, 2022, only labs registered with the Drug Enforcement Administration (DEA) can conduct testing; this date was extended from the IFR.
• Labs are not required to be approved or accredited, allowing more to participate.

Regulations that did not change from the IFR to the FR include:

• The total THC calculation requirement
• The USDA cannot increase the threshold of what is considered hemp from 0.3% to 1.0% THC content
• The USDA cannot license hemp growers who have had a controlled substance felony within the last 10 years

The webinar was moderated by Toby Astill of PerkinElmer, Chair of the AOAC/CASP Training and Education Working Group, and AOAC’s Chris Dent provided updates on CASP. For more information about the USDA Hemp Production Program’s Final Rule, visit https://www.ams.usda.gov/rules-regulations/hemp.

Speakers:

Bill Richmond, Chief, USDA Hemp Program, leads the team responsible for establishment and implementation of the U.S. domestic hemp production program. The USDA program oversees State and Tribal Government hemp regulations, rulemaking, intergovernmental affairs and stakeholder outreach. He has been in Federal service, all with USDA, for over 20 years. In other roles, he was the acting director of the team responsible for establishing new labeling rules for genetically modified foods in the U.S., served as the chief of staff of USDA’s Agricultural Marketing Service under the Obama and Trump administrations, and led USDA’s Colorado dairy field office. Richmond studied agricultural economics at the University of Maryland, and holds professional certificates from the Harvard Kennedy School of Government and the Brookings Institution.

Kerry Smith, Ph.D., is the Director of the Laboratory Approval and Testing Division (LATD). LATD provides laboratory testing and approval services to facilitate domestic and international marketing of food and agricultural commodities. Kerry was critical in the reorganization and standardization of the Agricultural Marketing Services’ (Agency) laboratory services. She has led significant process and service enhancements, making LATD a leader in residue, mycotoxin, and adulteration testing. In addition, LATD serves as the scientific arm of the Agency, providing subject matter expertise in many areas, including bioengineered foods and hemp production. Kerry has worked for the United States Department of Agriculture (USDA) for 16 years.