By Jessica Domel
Multimedia Reporter
The 2018 Farm Bill and action taken by the Texas Legislature paved the way for farmers to grow industrial hemp in the coming seasons, but state and federal officials’ work is far from over.
The Texas Department of Agriculture is tasked with creating an in-state program for hemp regulations that set guidelines for the growth and cultivation of hemp and submit it to the U.S. Department of Agriculture (USDA).
Meanwhile, USDA, the Department of Justice, Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) are working together to create their own rules and regulations for hemp farmers, processors and everyone involved in the supply chain.
The agencies are also tasked with, in some ways, answering the needs of the growing hemp industry.
Federal guidelines
The farm bill charged USDA with creating hemp rules and regulations, according to Undersecretary of USDA Marketing and Regulatory Programs Greg Ibach. He recently told the Senate Committee on Agriculture, Nutrition and Forestry the proposed rules are undergoing interagency review.
“We are unable to comment on the specifics of the rule at this time,” Ibach said.
The rulemaking will outline provisions for USDA to approve plans submitted by the states for production of hemp.
It also establishes a federal plan for farmers in states or territories that do not have a USDA-approved plan.
“The program includes provisions for maintaining information on the land where hemp is produced, testing THC levels, disposing of plants that are not in compliance with program requirements, licensing requirements and ensuring compliance,” Ibach said.
USDA is in the process of starting a hemp research program, as well.
Crop insurance
USDA’s General Counsel Stephen Vaden told the Senate Committee on Agriculture there’s not enough history to create a hemp crop insurance policy right now, but there will be an option for growers who decide to plant hemp.
“Hemp will be covered under a pilot program Whole Farm Revenue Policy for the coming crop year in 2020,” Vaden said. “As a pilot under the law, the Risk Management Agency (RMA) can assess the program and make changes as needed to maintain program integrity while also providing a product useful for hemp producers.”
Pesticides
In late August, EPA opened a 30-day comment period on 10 existing pesticide product applications for hemp.
EPA hopes to have decisions by the end of the year in preparation for the 2020 crop year.
“EPA is committed to assisting hemp producers obtain the pest management tools they need to help them transition to commercial production of the crop,” Alexandra Dunn, assistant administrator of EPA’s Office of Chemical Safety and Pollution Prevention, said. “EPA’s effective and long-standing methods for working with industry grower groups, states and other partners will ensure that producer requirements for pest management and environmental and public health protection can all be met and achieved.”
The agency will also set tolerances or maximum pesticide residue limits under the Food Quality Protection Act when hemp products are in a food or animal feed.
In food, supplements
Food products like hulled hemp seeds and products that are extracted from hemp derivatives—like cannabidiol (CBD) such as foods, drugs and cosmetics—fall under FDA purview.
“FDA first approved a CBD drug product last year for treatment of seizures associated with two rare and severe pediatric diseases, a significant milestone for these children and their families,” Dr. Amy Abernethy, FDA principal deputy commissioner, told the committee.
In line with the Food, Drug and Cosmetic Act, CBD may be marketed as the approved drug.
There has also been an explosion of CBD-based products like lotions, gummies and chocolates. Abernethy said providing regulatory clarity on those is an FDA priority.
“Under the Food, Drug and Cosmetic Act, adding CBD to food or marketing a CBD product as a dietary supplement, is generally prohibited unless the agency makes an exception through rulemaking,” Abernethy said. “The same rule applies to most active drug ingredients. It’s common sense. We generally don’t want drugs to be added to food.”
Abernethy said the FDA will make decisions about safety based on sound science. Unfortunately, due to its classification as a controlled substance, research on CBD has been restricted.
“We are moving as quickly as possible to learn what is known and develop a work plan to fill in the gaps,” Abernethy said. “We have formed a working group, which I co-chair, to expedite FDA’s work.”
FDA is reviewing published medical literature, all available databases and any information from industry sponsors.
Abernethy noted FDA is providing regulatory clarity whenever possible.
“Certain hemp products, hulled hemp seed, hemp seed protein powder and hemp seed oil can be legally used in human foods,” Abernethy said. “Similarly, the regulatory pathway for new CBD-based drugs is clear, and we understand clinical studies are ongoing.”
FDA has issued warnings to companies marketing CBD with therapeutic claims like treating cancer, Alzheimer’s and opioid withdrawal.
Industry advice
Ibach told the Senate Ag Committee he does have some concerns with the growing level of excitement and the number of farmers who may plan to plant hemp next year.
“We want to make sure that producers are aware and have an outlet for their products—some place to sell it,” Ibach said. “We have encouraged producers all this spring to look for a partner, look for a customer, and we encourage them to engage in a contract before producing hemp.”
Ibach is concerned hemp production and consumption won’t align.
There’s also been some concern regarding processing of hemp once it’s harvested.
The fiber processing industry has been slower to grow in the U.S. than CBD processing.
“For those producers who are interested in fiber production, there’s probably less alternatives right now in the processing,” Ibach said.
USDA will have to work with the Office of the U.S. Trade Representative, the state department and hemp growers as there could be international treaties that hinder the export ability of hemp products for processing.
Seed bank
On Aug. 2, Senate Minority Leader Charles Schumer announced half-a-million dollars in federal funding will be used to create the nation’s first hemp seed bank at Cornell University in New York.
According to Cornell, the funding from the fiscal year 2019 Omnibus Spending Package will be used by USDA’s Agriculture Research Service to create the industrial hemp germplasm repository.
Click here for more information from USDA on hemp regulations.