A new wheat cultivar that’s been gene-edited to boost fiber content can be commercialized without undergoing USDA’s deregulatory process for genetically modified crops.
The agency has decided the wheat variety, which was developed by the Calyxt biotech company, isn’t subject to USDA regulations for transgenic crops because it’s not a potential plant pest.
While genetically modified organisms regulated by USDA have traditionally incorporated foreign genes, Calyxt’s “nutritionally-enhanced wheat” is altered by knocking out a gene through a proprietary “targeted mutagenesis” process.
The company intends to “potentially commercialize” the wheat variety, which would involve “seed and grain production that would require both interstate movement and unconfined environmental release,” according to its letter to USDA.
Aside from confirming the cultivar isn’t regulated as a plant pest, the USDA has also determined the gene “knockout” will not increase the weediness of wheat or jointed goatgrass, a related species.
Calyxt’s high-fiber wheat is the second gene-edited variety of the crop that USDA has cleared for commercialization without the environmental review required for deregulating transgenic crops.
In 2016, the company’s powdery mildew-resistant wheat, also created through a gene knockout, was determined to be nonregulated by the agency.
Gene-edited wheat hasn’t drawn a reaction from U.S. trading partners because the traits haven’t been widely adopted in the wheat industry, said Steve Mercer, vice president of communications for U.S. Wheat Associates, an export organization.
“It has not come up because it’s not anywhere close to commercialization,” Mercer said.
Commercializing a cultivar typically requires lengthy trials and ramping up seed supplies, but Calyxt is a genetics developer that will likely license or sell its traits to a seed company or a public university, he said.
It’s uncertain how foreign wheat buyers will react to gene-edited varieties, but U.S. Wheat Associates is supportive of the technology, he said.
Unlike traditional genetic engineering, gene editing is less expensive and thus more available to public breeders, Mercer said. “It does not have to be the big tech providers.”
The American Seed Trade Association is hopeful that gene-edited crops will not encounter the same uneven patchwork of international rules as traditional GMOs, said Bernice Slutsky, the group’s senior vice president of domestic and international policy.
Before any gene-edited crops come onto the market, the global seed industry is trying to develop consistent science- and risk-based policies for the technology across countries, Slutsky said.
Because developers are working within a plant’s own gene pool, there’s an interest in gene-editing research even in GMO-wary jurisdictions, such as Japan and Europe, she said.
“There is a feeling they should not be treated as a GMO,” Slutsky said.
However, critics of biotechnology doubt that consumers will embrace gene edited crops — particularly the health-conscious market segment to which high-fiber wheat is intended to appeal.
Fiber is commonly extracted during the manufacturing of white flour, but it’s found in whole wheat, said Bill Freese, science policy analyst for the Center for Food Safety.
“Consumers can achieve the same effect — more naturally and safely — by consuming more whole and fewer refined-grain products,” he said in an email.
Key information about the high-fiber wheat is redacted from Calyxt’s submission to USDA, whereas it would otherwise be shared with the public under the deregulatory process, Freese said.
Without such information, there’s no way to evaluate whether the modification may have unintended side effects, such as “novel carbohydrates that humans haven’t encountered before,” he said.