The U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA APHIS) has determined that Soilcea’s modified sweet orange, which reportedly has resistance to HLB, is not a plant pest or a plant that requires regulation under 7 CFR part 340. USDA APHIS regulates the “Movement of Organisms Modified or Produced through Genetic Engineering” as described in 7 CFR part 340.
“Please be advised that your plant product, while not regulated under 7 CFR part 340, may be subject to APHIS Plant Protection and Quarantine (PPQ) permit and/or quarantine requirements,” USDA APHIS Deputy Administrator Bernadette Juarez advised Soilcea in a Sept. 26 letter.
In May 2023, Soilcea requested a Regulatory Status Review for sweet orange developed using genetic engineering (modified sweet orange).
“In your letter, you described that the sweet orange was modified to impart resistance to citrus greening (HLB) via decreased production of two host targets of Candidatus Liberibacter asiaticus effector proteins,” Juarez wrote. “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. APHIS has determined your sweet orange is unlikely to pose an increased plant pest risk relative to its comparators.”
She noted that APHIS’ decision applies to the sweet orange developed using genetic engineering exactly as described in the Soilcea letter.
According to Soilcea, it has developed CRISPR-edited citrus trees that are resistant to HLB and citrus canker, both serious citrus diseases in Florida. The company has exclusive commercial licenses to patents to HLB and canker target susceptibility genes and optimized CRISPR transformation methods for citrus developed by Nian Wang’s lab at the University of Florida Institute of Food and Agricultural Sciences. Wang, Graves Eminent Scholar Endowed Chair in Biotechnology, works at the Citrus Research and Education Center in Lake Alfred.
Source: USDA APHIS
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