Soilcea has developed a gene-edited variety of orange resistant to citrus greening disease.

A variety of orange gene-edited to resist citrus greening disease won’t be subject to USDA biotech regulations, clearing the way for its commercialization.

The agency’s Animal and Plant Health Inspection Service, or APHIS, has determined it lacks authority over the orange cultivar under federal genetic engineering rules, which focus on crops altered with DNA from plant pests.

The USDA’s determination was issued at the request of the orange’s developer, allowing the variety to be grown freely without permits or undergoing extensive evaluations required for deregulating some biotech crops.

“APHIS did not identify any plausible pathway by which your modified sweet orange, or any sexually compatible relatives, would pose an increased plant pest risk relative to comparator sweet orange plants,” the agency said in the regulatory determination.

The cultivar’s developer, Soilcea of Tampa, Fla., expects the USDA’s decision will allow the orange to be commercialized within 18-24 months, as it’s already working with two nurseries on propagation.

“We want to get these trees into the hands of growers as fast as we can,” said Yianni Lagos, the startup’s CEO, noting that citrus greening has had devastating impacts on the industry.

Lagos grew up on a farm in Ohio and retained his fascination with agriculture while pursuing law and business degrees, eventually leading him to start Soilcea.

The company licensed the findings of Nian Wang, a professor at the University of Florida, who discovered the genes that leave orange trees vulnerable to Huanglongbing, or HLB, another name for citrus greening.

Soilcea’s orange variety was developed by turning off those genes with CRISPR, a gene-editing technology, which renders the tree inhospitable to the bacteria.

About 18 months ago, the company’s trees were planted in a field trial that’s so far proven successful in demonstrating the variety’s resistance to the pathogen.

“The CRISPR trees are looking big, green and beautiful while the other trees are having severe HLB symptoms,” Lagos said.

Though the company’s data shows the cultivar has continued to withstand the disease, it’s too early to say it won’t eventually falter, he said. Even so, Lagos said he has every reason to be optimistic.

“Until the tree is 10 years old, we can’t say with absolute certainty,” he said. “Every six months, we get even more confident.”

Biotech startups often rely on risky funding from venture capital firms to stay afloat and encounter “undisclosed technical difficulties” or market resistance, said Bill Freese, science policy analyst with the Center for Food Safety, a nonprofit that’s critical of USDA biotech rules.

Though Freese doesn’t know the specifics of Soilcea’s financial situation, he said predictions that “success is right around the corner” should generally be taken with a grain of salt in the biotech sector.

“I’ve seen many such commercialization predictions belied by facts,” Freese said.

Due to heavy redactions of the data that Soilcea submitted to USDA, “more transparency would be desirable here,” as it’s not clear exactly how the gene editing was achieved, he said.

The USDA’s review concentrates narrowly on the “intended outcome of the genetic engineering,” which includes gene editing, without considering the potential for undesirable side-effects, Freese said.

The genes and proteins turned off or knocked out through gene editing often have “multiple functions,” so the full impact of the change isn’t really understood, he said.

“Biotechnologists focus on the one they’re interested in, and often disregard the consequences of disrupting other functions,” Freese said.