NAPIGEN, Inc.’s Gene-Edited Rice With CMS is Not Subject to Regulation According to USDA
The United States Department of Agriculture (USDA) responded to the Am I Regulated (AIR) Inquiry from NAPIGEN, Inc., notifying the company that its rice with gene-edited mitochondrial DNA is not subject to regulation.
NAPIGEN has modified rice mitochondrial DNA using proprietary organellar gene editing technology, introducing a gene that conveys the cytoplasmic male sterility (CMS) trait. The CMS trait is a vital component in the development of higher-yielding hybrid rice lines.
The USDA’s Biotechnology Regulatory Services (BRS) of the Animal and Plant Health Inspection Services (APHIS) notified NAPIGEN that it has determined that the company’s gene-edited rice product with a CMS trait is not subject to USDA regulation under 7 CFR Part 340.
This is because the rice plants are not themselves plant pests and no plant pest sequences would remain integrated in the rice genome. Before commercialization, NAPIGEN’s gene-edited CMS rice plants may be subject to regulatory review by other government agencies.
The USDA’s response has allowed NAPIGEN to take the first step towards commercializing the rice plants. It also marks a significant milestone for NAPIGEN’s innovative mitochondrial gene editing technology. This emphasizes its capacity to replicate a naturally occurring phenomenon in plant mitochondria and highlights its potential applicability to other vital crops such as wheat.
NAPIGEN’s rice plant with the CMS trait is the first example of a plant with gene-edited mitochondrial DNA undergoing regulatory review by the USDA.
President and CEO of NAPIGEN Dr. Hajime Sakai said that the USDA decision is “a crucial step in the development and deployment of its rice products.” He added, “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.”
“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.
The USDA decision allows the acceleration of NAPIGEN’s efforts to integrate the CMS trait into elite rice varieties, enhancing the production of high-yielding hybrid rice. The CMS trait is a crucial component in hybrid seed production.
Hybrid plants produced from hybrid seed offer an important solution to the growing global demand for food. Compared to non-hybrids, hybrid plants produce 15 to 20 percent more grain and exhibit resilience to drought and biotic stress due to the stacked superior genetics from both parental plants.
Emil M. Orozco, Vice President of Intellectual Property at NAPIGEN stated, “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.”
