USDA, FDA and EPA say they are moving as quickly as they can to gather data and plug the regulatory gaps holding back potential hemp producers.
The Agriculture Department’s Risk Management Agency is working on crop insurance, the Food and Drug Administration is marshaling data to determine health risks of hemp-derived cannabidiol, or CBD, in food for humans and animals, and the Environmental Protection Agency is collaborating on research to come up with crop protection chemicals for the crop.
“We need to be very focused in the data that is ultimately sought after so we do not unduly take extra time or extra resources to get to the answers the American public and American farmers need,” FDA Principal Deputy Commissioner of Food and Drugs Amy Abernethy told the Senate Agriculture Committee at a Thursday hearing.
Abernethy’s testimony underscored the complexity of the effort to implement the legalization of industrial hemp in the 2018 farm bill. She said in approving the CBD product Epidiolex for treatment of epilepsy last year, FDA learned “CBD is not a risk free substance.” It can harm the liver, affect appetite and create a sense of exhaustion, she said.
In addition, she said the effects are unknown on pregnant and nursing mothers or people with a major illness.
Abernethy also said FDA needs data on the safety of animal feed containing hemp or CBD, which includes looking at how much CBD accumulates in animals, given they generally eat the same thing each day.
“FDA is wrestling with questions not only about the intrinsic safety of CBD, but also about potentially unsafe manufacturing processes for products containing CBD,” Abernethy said. “FDA will only consider creating legal pathways for CBD to be marketed as a dietary supplement or in a food if the agency is confident that it can develop a framework that addresses safety concerns.”
USDA Undersecretary for Marketing and Regulatory Programs Greg Ibach and USDA General Counsel Stephen Vaden both assured Committee Chair Pat Roberts, R-Kan., that USDA would implement its hemp program in as “farmer-friendly” a way as possible. An interim final rule implementing hemp provisions of the 2018 farm bill was sent to the Office of Management and Budget June 27 and is now subject to interagency review.
Following the hearing, Ibach said he expected it to be published in early to mid-fall.
RMA will allow hemp to be insured under its whole-farm revenue program until it gets a hemp-specific insurance program off the ground.
Roberts was concerned about “analytical variances” in tests done for THC levels in hemp and asked Vaden whether USDA is legally required “to implement any testing regime in the upcoming regulation to a strict 0.3% with no variations?” The farm bill defined industrial hemp as containing no more than 0.3% of THC on a dry weight basis.
Responded Vaden: “Thankfully, Congress gave USDA the tools it needs to draw from the experiences from the states that have been participating in the 2014 [farm bill’s] pilot program in order to understand the best testing methodologies that are available, what their limitations are and to factor that in with the discretion given to the agency to set up a testing program in order to ensure that the program we put forward is farmer-friendly and does not unwittingly trap farmers who are doing their level best to abide by the 0.3 limit that Congress set in the statute."
EPA is working with the Inter-Regional Research Project #4 (IR-4) to develop pesticides for hemp, specifically by creating protocols for field trials to support tolerance petitions — requests to set allowable pesticide residue levels in hemp.
Dunn said IR-4 representatives and her staff were meeting Thursday, July 25, to discuss hemp. “I think we’re in a very good position to move forward with IR-4,” she said.
The second panel featured Brian Furnish, a Kentucky hemp grower and processor who was the first to receive a permit to grow hemp under Kentucky’s 2014 pilot program; Erica Stark, executive director of the National Hemp Association in Reading, Pa.; and Darrell Seki, tribal chairman of the Red Lake Band of Chippewa Indians in Red Lake, Minn.
Furnish urged growers to “enter hemp with caution — extreme caution.”
“The reality is you can make a living growing hemp, but you will not become rich in one year,” he said.
Seki said tribes are behind in their efforts to enter the hemp market because they were not allowed to participate in the 2014 farm bill’s pilot program.
The Agricultural Marketing Service “has sought to clarify its interpretation of the 2014 Farm Bill authority and how it will apply to tribes in the 2019 growing season,” Seki said, but “it still limits and requires tribal sovereignty to take a back seat to state authority.”
Stark said consistency in testing protocols is essential for the successful implementation of the farm bill’s hemp provisions.
She said the National Hemp Association is recommending that testing procedures to determine THC in post-decarboxylated hemp use Gas Chromatography-Flame Ionization Detection (GC-FID) or High-Performance Liquid Chromatography (HPLC).
“GC-FID and HPLC are the most commonly used testing methods by states,” she said.
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