Regulatory Changes Simplify Approval for Some Genetically Edited Crops

Many Americans likely missed hearing about the regulatory shift a few years ago inside USDA allowing exemptions or speedier approvals of certain genetically altered plants.

Inside the Donald Danforth Plant Science Center in St. Louis, however, plant researchers absolutely had the new SECURE rule – which means: Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient – on their radar.

Donald MacKenzie, Institute for International Crop Improvement, Donald Danforth Plant Science Center – St. Louis: “Within the SECURE rule, it identified specific exemptions for genome-edited products and, as well, it made life a little easier even for genetically engineered products because, if you were working on a product that had a similar mode of action to another genetically engineered crop that had already received approval from USDA, then the work stream was a lot easier and less complicated.”

Some have objected to the rule from the outset, including the food safety and nutrition advocacy group Center for Science in the Public Interest, which believes food made from currently approved GMO seeds are safe to eat and benefit farmers and the environment. However, the 50-year-old group is concerned that many plant breeders have too great a financial incentive to self-proclaim eligibility for bypassing regulatory steps.

According to a 2023 Congressional Research Service report, the 2021 law “helped expedite” the time period for approval of biotech plants to about 41 days. However, after repeated inquiries by Market to Market, federal officials would not or could not provide the number of days previously required for processing.

The approval process has become less costly for some projects, and the report says it is primarily mid-sized and smaller entities that have applied.

For the nonprofit Donald Danforth Plant Science Center, which does research on food-security crops and on plants that boost agricultural sustainability, the changes mean getting improved seed into the hands of farmers more quickly. One of the group’s current projects focuses on teff, a small grain popular in the eastern African countries of Ethiopia and Eritrea. Teff, a staple for about 80 million people, is turned into flour and used in injera, a spongy flatbread.

Donald MacKenzie, Institute for International Crop Improvement, Donald Danforth Pliant Science Center – St. Louis: “We had to go through a consultation process with USDA, which we did, and they ultimately determined the edited teff would not be subject to regulation. For us, that makes a big difference; it really reduces the complexity and the cost with downstream product development. It means we can go directly into open field trials without having to deal with conditions of isolation, segregation and the like.”

The Danforth Center has been working on a shorter-stemmed teff that may be less susceptible to lodging, a condition where the plant falls over in heavy rains or high winds, typically reducing yield by a quarter. The genetically edited teff is a modern take on the work done for wheat by Norman Borlaug, who used traditional breeding techniques over many years to reduce lodging, moderated starvation, especially on the Asian continent, and resulted in what is known as the “Green Revolution.”

Getu Duguma, Donald Danforth Plant Science Center – St. Louis: “But now, since we know what genes contributed to the Green Revolution through modern technology called CRISPR genome editing, now we can go find out similar gene in this crop and then knock it out so that the plant can be lodging-resistant.”

Getu Duguma, the lead researcher on the project, grew up on a farm in Ethiopia, where his family raised teff and corn, doing all the field work done by hand.

Getu Duguma, Donald Danforth Plant Science Center – St. Louis: “It’s personal because I grew up with this crop. I know the problems so I know how much farmers are losing by growing this crop because of lodging issues. So that’s why I wanted to be part of that solution…. This is the first gene-edited teff that is planted anywhere else….we want to replicate that where this crop is really valuable…. The main goal is for us to market this crop in Ethiopia…we deliver this free-of-charge to farmers there because we do humanitarian work.”

They are ready to work with an Ethiopian research institute to test the new genetically edited teff in the African countryside. Because no foreign genetic material has been introduced, Danforth hopes the edited teff can be grown without being subject to the Ethiopian agricultural policies that govern genetically engineered crops.

Getu Duguma, Donald Danforth Plant Science Center – St. Louis: “Countries like Nigeria, Kenya have already adopted the favorable policy for gene edited product. But most countries are still considering adoption of gene-edited materials…In a few years to come, I think there should be very favorable policy in place for genome-edited product.”

Danforth has also genetically altered cowpeas to protect them from pod borers in Nigeria and cassava to protect it from a plant virus in Kenya. The seeds are passed to African farmers without royalties, unless the in-country partner chooses to set a fee.

MacKenzie says breeding plants to better endure weather extremes while spending less money and time on regulatory steps is key.

Donald MacKenzie, Institute for International Crop Improvement, Donald Danforth Plant Science Center – St. Louis: “If we consider genetically engineered crops and foods, it’s important to remember that these products have been approved in more than 70 countries around the world, including the European Union for direct use in feed, food and for processing, and in every case, the regulatory agencies have all been unanimous in their approval. We haven’t had dissenting decisions anywhere.”

By Colleen Bradford Krantz, colleen.krantz@iowapbs.org