Comments on USDA Interim Final Rule on Hemp

January 29, 2020

Docket Clerk

Marketing Order and Agreement Division, Specialty Crops Program, AMS

United States Department of Agriculture
1400 Independence Avenue SW, STOP 0237
Washington, DC 20250-0237

Re: Comments on Docket No. AMS-SC-19-0042 SC19-990-2 IR; Document Number: 2019-23749

Dear Sir or Madam:

The Pennsylvania Farm Bureau (PFB) is the state affiliate of the American Farm Bureau Federation (AFBF), the nation’s largest general farm organization, representing farmers and ranchers in all fifty states and Puerto Rico. PFB itself is a general farm organization, made up of more than 62,000 members. Since 1950, PFB has provided support, advocacy and informational and professional services for Pennsylvania agriculture and farm families producing a diverse array of food and fiber for American consumers. We appreciate the opportunity to submit comments to the U.S. Department of Agriculture (“USDA”) regarding its Interim Final Regulations on Establishment of a Domestic Hemp Production Program (IFR), which were published in the Federal Register on October 31, 2019.

General Comments

The 2018 federal Farm Bill removed hemp from the Controlled Substances Act, and in so doing, effectively transferred the authority to regulate hemp from the Department of Justice to other relevant administrative agencies, including USDA. This shift has led to a significantly increased interest in hemp production generally. PFB is interested the development of this crop as an additional tool for farmers and assisting interested members in entering the industry.

USDA’s efforts to ensure that regulations are in place for the 2020 growing season and beyond are welcome; however, while PFB believes that the IFR provides guidance on many issues and uncertainties that have persisted since the passage of the Farm Bill, there are areas in which the regulations could be revised or expanded upon to further support the industry. With that in mind, PFB respectfully wishes to offer these comments on the IFR.

Areas of Concern

1. Since the IFR requires that hemp be tested not only for delta-9 tetrahydrocannabinol (delta-9 THC), but also for THC acid (THCA), this approach may artificially cause a “hot crop” outside the definition of industrial hemp, risking crop destruction even as the delta-9 THC level, as defined in the 2018 Farm Bill, is below the 0.3% threshold.

Specifically, while the 2018 Farm Bill calls for THC concentration to be measured “using post-decarboxylation,” the statutory provisions also explicitly allow for “other similarly reliable methods.” There are reliable methods in which THC can be measured independently, including high-performance liquid chromatography. In requiring THCA to be measured, USDA has gone beyond what is statutorily required.

Despite USDA’s intention of providing clarity and standardization in testing methodologies, the reality of the so-called “Total THC” approach creates further confusion and vulnerability for hemp farmers, which are currently complying with the 2014 Farm Bill’s Hemp Research and Pilot Programs and within the 2018 Farm Bill’s statutory requirement for testing delta-9 THC. Additionally, the USDA IFR requires testing for only a portion of the plant—the flower—which happens to be the portion with highest THC content, even though farmers harvest and process the entire plant–which means that the USDA tests prepare for a worst-case scenario of THC testing, and do not account for the fact that THC levels fluctuate over time based on plant stressors and other factors. PFB believes that the required testing of a plant should include the flower, leaf, and stem from parts of the entire plant in equal proportion, as opposed to only the top third of the plant.

PFB is cognizant of the concerns of law enforcement, and understands the need to define a threshold level of THC to distinguish between legitimate hemp crops and marijuana. However, PFB believes that a “Total THC” threshold of 0.3% will deter farmers growing hemp for use in CBD products from entering the market. PFB supports hemp THC levels up to 1%, but also realizes a statutory change must happen in order to change the THC threshold.

The IFR also does not afford any provisions for growers to salvage crops, and allows only limited circumstances for retesting where crops exceed the established 0.3% THC threshold. This is a significant issue because crop insurance does not provide protections in these circumstances. The IFR allows producers operating under USDA’s hemp plan to request that their samples be retested “if it is believed the original delta-9 tetrahydrocannabinol concentration level test results were in error.” As a starting point, USDA should consider requiring state plans to include corresponding provisions for retests. Further, PFB encourages USDA to consider adopting provisions that would enable farmers to salvage crops which a) do not exceed the established 0.3% THC threshold upon retest, and b) develop approaches for farmers to find economic use of crops that exceed the 0.3% THC threshold, such as requiring deconstruction of the flowers but allowing the rest of the plant to be used for fiber.

Finally, PFB supports that the IFR defines the “acceptable hemp THC level” as “the application of measurement of uncertainty to the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis produces a distribution or range that includes 0.3% or less.” The measurement of uncertainty helps to address the inherent statistical uncertainty that occurs in the testing process. This flexibility should be retained in the Final Rule.

2. The inclusion of a “safe harbor” provision in the IFR to protect farmers from prosecution through is a welcome inclusion. Specifically, the Rule specifies that hemp producers do not commit a negligent violation if they produce plants that exceed the acceptable hemp THC level and use reasonable efforts to grow hemp and the plant does not have a THC concentration of more than 0.5% on a dry weight basis. USDA should work with the Department of Justice, DEA, and other agencies to come up with cohesive guidance and information regarding enforcement against hemp growers.

3. Given the reality of time and labor commitments for harvesting, the 15-day sampling requirement specified under USDA’s IFR is unrealistic for hemp producers. The IFR requires that samples for testing of hemp for THC concentration levels be collected within fifteen days of the anticipated date of harvest. The regulations go on to specify that state hemp programs must prohibit industrial hemp farmers from harvesting their crop until the samples have been taken.

To sample and harvest an entire crop within a 15-day period requires major financial investment with no guarantee of completed testing, placing hemp growers in a vulnerable position. States have also expressed concern over this timeline. Because testing may not be completed within the 15-day timeline, hemp growers may harvest and prepare an entire crop that tests above the THC threshold and is, by definition, marijuana, which then must be destroyed. Additionally, if farmers wait on the testing to be completed and ensure that the crop tests at or below the acceptable THC level, they may be required to harvest their crop on an even shorter timeline than 15 days. This could require hiring extra laborers or purchasing of extra equipment. At the same time, farmers who are unable to complete harvest in a timely manner due to weather factors should not be punitively penalized. USDA should allow for a longer harvest period or waivers on a case by case basis in the case of adverse weather.

PFB appreciates that the 15-day requirement attempts to provide clarity in testing and ensure that the crop tested and the crop that is harvested are at the same THC level. But in practice, this creates extra hurdles and impacts the financial viability of hemp farmers. USDA should revisit this requirement to balance between testing at a standard to obtain adequate validation of THC levels and placing an unfair and expensive burden on farmers. PFB supports extending this 15-day requirement to testing the crop 45 days before harvest.

4. PFB encourages USDA to collaborate with the Department of Transportation, the Department of Justice, DEA, and states to develop a uniform and consistent approach to regulation of interstate hemp transportation. PFB encourages USDA to collaborate with the Department of Transportation, the Department of Justice, DEA, and states to develop a uniform and consistent approach to regulation of interstate hemp transportation.

5. Given a relative lack of DEA-registered laboratories available for THC testing, PFB suggests that USDA work with DEA to provide guidance on how a lab might become DEA-registered, and provide farmers with strong assurances that DEA will expedite this process and ensure that an adequate fleet of labs are available for the 2020 season. USDA’s interim regulations require that “testing is completed by a DEA-registered laboratory using a reliable methodology for testing the THC level.” The DEA, through its website and other published material, does not specify locations for DEA-registered laboratories. The only available description of these laboratories provided by DEA notes that they are primarily located in states where marijuana is legal. Subsequent to USDA releasing the IFR, USDA has added to its website a list of hemp testing laboratories who are registered with the DEA.

As of January 27, this list shows that there are only 44 laboratories in 22 states. Having only 44 laboratories to service hundreds of hemp farmers will inevitably lead to testing delays and backlogs. Moreover, given the lack of an acceptable laboratory for testing THC levels in hemp in every state, hemp growers may be required to transport or ship untested samples of hemp plants across state lines to comply with USDA regulations. In the process of transporting hemp samples to be tested, hemp farmers run the risk of sending hemp plants that contain or may test above 0.3% THC by dry weight, and therefore will have shipped marijuana across state lines. So, to comply with USDA’s regulations, hemp producers may provide evidence to the DEA that they have committed a federal crime—transporting a controlled substance across state lines—and be at risk of prosecution.

In many states where hemp programs are in place under the 2014 Farm Bill, the states have required testing to be done by private labs with private certification, including ISO 17025 accreditation. ISO 17025 accrediting requires third-party assessors to evaluate the laboratory and its ability to produce precise, accurate test and calibration data. To maintain this accreditation, laboratories must be regularly reassessed to ensure that technical expertise is maintained. Additionally, the regulations require laboratories to meet the AOAC International standard method performance requirements for selecting an appropriate method. With multiple methods meeting these requirements, and numerous other methods available that have managed to successfully test THC limits, USDA should open testing requirements beyond just DEA laboratories. Limiting laboratories to only one form of registration will severely limit the availability and processing time for testing. PFB requests that USDA allow testing to take place in private labs, with third-party accreditation, such as ISO 17025, which ensures accuracy and technical expertise, to minimize the undue delay, burden, and cost on hemp cultivators.

6. USDA should develop a federal seed certification program. USDA final regulations omit a federal seed certification program. Under the 2014 Farm Bill’s Hemp Research and Pilot Program, various states developed seed certification programs to help producers identify hemp seed that would work well in their specific geographical areas. USDA’s choice not to include a federal seed certification program means that individual cultivators remain liable to the 0.3% delta-9 THC standard. A federal seed certification would be the best approach to support the industry, by providing clarity both to hemp farmers and seed cultivators. Without such a program, farmers risk investing in seed that produce plants that do not qualify as hemp under the THC standard.

7. Allowing simple, more time and cost-effective methods for disposal overseen by state agriculture departments and law enforcement agents would provide greater flexibility and minimize burdens on the regulators and farming community than leaving this responsibility in the hands of the DEA or another federal agency. For disposal of non-compliant crops, the IFR requires that the DEA or another entity authorized to handle marijuana under the Controlled Substances Act will dictate the process for disposal. This will likely create unnecessary and costly burdens on both the farmers and the states and tribes managing industrial hemp programs. Additionally, rather than dispose of 100% of a hot crop, PFB supports alternative uses of a product that has tested in excess of the established 0.3% threshold so that a producer does not lose 100% of the significant investment incurred in planting and growing a hemp crop.

In closing, PBA appreciates USDA’s efforts to provide clarity and fill in regulatory gaps through promulgation of the interim regulations, and supports USDA’s efforts to create an established domestic hemp production program that benefits Pennsylvania farmers and others with an interest in the hemp industry.

Thank you again for the opportunity to share these comments.

Best regards,

Grant R. Gulibon
Director, Regulatory Affairs