The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has granted Amfora, Inc. an exemption for its gene-edited, ultra-high protein soybeans.

The exemption is a determination by the USDA’s APHIS that Amfora’s soybeans are not subject to the regulations in 7 CFR Part 340 and can be marketed without undergoing further review by USDA. The decision accelerates the path to commercialization for Amfora’s ultra-high protein soybeans.

The ruling opens the door for Amfora’s gene-edited soybeans to provide a scalable, low-cost, high-density protein source. It comes as there is an urgent need for sustainable protein production that can address the growing global demand while reducing the environmental impact associated with the production of traditional animal protein sources. The company expects to apply this patented technology to other food and feed crops including peas and other legumes, and grains including rice and wheat. The company anticipates that these crops would also receive similar exemptions from the USDA.

“This regulatory decision will accelerate our ability to scale the sustainable production of protein from soybeans,” said Lloyd Kunimoto, CEO of Amfora. “Our ultra-high protein crops will enable manufacturers to meet the rapidly growing demand for plant-based proteins at lower costs while taking meaningful steps to address climate change and food insecurity.”

The decision marks a significant step forward in Amfora’s efforts to enhance the nutritional density of food and feed crops, specifically by increasing the protein content of soybeans to meet the growing global demand for sustainable protein sources. The company’s ultra-high protein soybeans contain approximately 25 percent more protein than conventional soybeans, making them an ideal plant-based ingredient for meat alternatives, aquaculture feed, and other protein-rich foods. In addition to supporting Amfora’s development of ultra-high protein soy, the technology can be used to reverse decades of decline in protein content of commodity soybeans.

To increase the protein content of its soybeans, Amfora’s patented process uses CRISPR gene editing to upregulate the activity of a specific gene. The upregulated activity increases the protein level and decreases the carbohydrate level in the soybeans. The process does not introduce any foreign DNA into the soybean and increases protein content. Patents covering this method to increase protein content in soybean and other crops have been broadly filed in the United States and internationally.

Amfora’s ultra-high protein soybeans are poised to make a significant impact on global food security and nutrition. By increasing the protein content of soybeans, Amfora offers a more complete source of nutrition, and supporting the health and wellness of populations worldwide. At the same time, the reduced need for fertilizers and the lower environmental toll of producing these gene-edited crops align with global efforts to combat climate change and promote sustainable agricultural practices.

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