For years now, the US Department of Agriculture has been flirting with the latest and greatest DNA manipulation technologies. Since 2016, it has given free passes to at least a dozen gene-edited crops, ruling that they fall outside its regulatory purview. But on Wednesday, March 28, the agency made its relationship status official; effective immediately, certain gene-edited plants can be designed, cultivated, and sold free from regulation. “With this approach, USDA seeks to allow innovation when there is no risk present,” US Secretary of Agriculture Sonny Perdue said in a statement.
The agency’s logic goes like this: Gene editing is basically a (much, much, much) faster form of breeding. So long as a genetic alteration could have been bred in a plant—say a simple deletion, base pair swap, or insertion from a reproductively compatible relative—it won’t be regulated. Think, changes that create immunity to diseases, hardiness under tough weather conditions, or bigger, better, tastier fruits and seeds. If you want to stick in genes from distant species, you still have to jump through all the hoops.
The move shouldn’t come as a shock, given the agency’s recent overtures. But it is a big deal, shaving years and tens of millions of dollars off the cost of developing a designer plant, and enabling smaller startups and public institutions to enter the market. Traditional genetic modification—and all its attendant red tape—has limited research to commodity crops like corn, soy, and wheat. Now, specialty crops, even ones with teeny tiny markets, are suddenly worth developing. You no longer have to be a Monsanto or a Dow DuPont Pioneer to take your custom cultivar into the grocery aisles of America.
“Having this consistent position enables smaller companies and academic labs to form this ecosystem of innovation to bring options to consumers,” says Federico Tripodi, CEO of Calyxt, a Minnesota-based gene editing firm. His company has already planted rows and rows of genetically edited soybeans that produce oil able to withstand high cooking heat without producing trans fats. It’s also developing healthier potatoes and designer wheats—low-gluten and high-fiber versions. San Diego-based Cibus tweaked one letter in canola’s genetic code to create an herbicide-resistant version; farmers are growing it in North Dakota and Montana. And Yield10 Bioscience, based in Woburn, Massachusetts, has modified flax to boost its omega-3 content.
They might be the first crop of gene-editing seed shops, but they’re about to get more competition. Thanks in part to a surprising decision last October by two of the major Crispr patent powerhouses—the Broad Institute and Dupont Pioneer—to provide non-exclusive licenses of their foundational IP to any company that wants to develop agricultural products.
Public research institutions can see a way forward as well. In Myeong-Je Cho’s lab at the Innovative Genomics Institute at Berkeley, grad students are growing cacao plant seedlings, edited to withstand the warmer conditions that are drying out the tropical rainforests in which they thrive. Without such changes, cacao is on course to disappear from the Earth in just a few decades. Crispr pioneer Jennifer Doudna is overseeing the work, which is funded in part by Mars candy company.
With all this disruption looming, GMO giants are quietly making moves to secure their relevance. Just this week, Monsanto announced it was investing $125 million in a startup co-founded by gene-editing standouts Feng Zhang and David Liu. Called Pairwise, it aims to put the first Crispr’d produce in people’s crisper drawers; sweeter strawberries could be among its earliest offerings.
So how will you know if the contents of a future salad has had a few As, Ts, Cs, and Gs moved around by a bacterial enzyme-wielding scientist? Well, you might not. Neither the USDA nor the US Food and Drug Agency has yet issued guidance specific to the the labeling of foods derived from gene-edited plants. According to an FDA spokesperson, the agency is considering public comments on whether these types of foods pose additional risks. But it couldn’t provide a timeline for any new policies. The USDA is supposed to have its own product disclosure rules finalized by July—a proposal is currently under review with the Office of Management and Budget.
Despite the legal limbo, regulatory lawyers see hints in Secretary Purdue’s statement—in particular, the part where he declared the products of gene-editing as indistinguishable from those developed through traditional breeding methods. “Bioengineered foods are defined by containing genetic material that could not otherwise have been conventionally bred or obtained in nature,” says Deepti Kulkarni, who joined law firm Sidley Austin after years in the FDA’s Office of Chief Counsel. “If USDA is construing the language this way, there is some suggestive signaling that these products might not be subject to disclosure.” Which means that you might not even realize when Crispr’d foods start showing up in your shopping cart.
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