WILMINGTON, DE — NAPIGEN, Inc., a biotechnology company specializing in advanced gene-editing technologies, has received notification from the U.S. Department of Agriculture (USDA) confirming that its gene-edited rice with mitochondrial DNA is not subject to USDA regulation. This decision marks a significant milestone in the company’s efforts to commercialize hybrid rice varieties featuring enhanced yields and sustainability traits.
The USDA’s Animal and Plant Health Inspection Services (APHIS) Biotechnology Regulatory Services (BRS) determined that NAPIGEN’s rice plant carrying the cytoplasmic male sterility (CMS) trait does not meet criteria for regulation under 7 CFR Part 340. The gene-editing process ensured that no plant pest sequences remain in the rice genome, exempting it from oversight as a plant pest. While the USDA decision provides a regulatory green light, the gene-edited rice may still need additional approvals from other agencies before being fully commercialized.
Using its proprietary organellar gene-editing technology, NAPIGEN introduced the CMS trait into the mitochondrial DNA of rice. This trait is essential for producing hybrid plants that are high-yielding, as hybrid crops often outperform non-hybrid counterparts by 15 to 20 percent in grain production while demonstrating enhanced resilience against drought and pests.
Dr. Hajime Sakai, President and CEO of NAPIGEN, celebrated the USDA ruling as a pivotal step. “NAPIGEN intends to advance its product development to ensure that farmers in the U.S. and worldwide will benefit from these improved rice varieties, ultimately contributing to food security and sustainable agriculture,” said Sakai.
The CMS trait is well-established as a key enabler in hybrid seed production, which supports global food security by optimizing crop performance. NAPIGEN’s efforts to integrate this trait into elite rice lines aim to meet the rising global demand for food amidst increasingly variable environmental conditions.
“This positive regulatory development is welcome news for advancing our technology to improve crop yields,” said Byung-Chun Yoo, Director of Business Development at NAPIGEN.
Executive Vice President Emil M. Orozco emphasized the significance of the advancements in plant biotechnology achieved by NAPIGEN. “Stable transformation of mitochondria in higher plants is a goal that has eluded plant scientists for over thirty years. NAPIGEN has been vigorously pursuing protection of our intellectual property with two issued U.S. patents and additional pending patent applications in the U.S. and select foreign countries,” Orozco stated.
This USDA milestone positions NAPIGEN to refine its mitochondrial gene-editing technology and expand its application to other staple crops, such as wheat. With the CMS rice product laying the groundwork, the company’s innovation is poised to create new opportunities for hybrid seed production and sustainable agriculture globally.
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