ROSARIO, Argentina– Bioceres Crop Solutions Corp. (“Bioceres” or the “Company”) (NASDAQ: BIOX), a fully integrated provider of crop productivity solutions designed to enable the transition of agriculture towards carbon neutrality, announced today that the U.S. Food and Drug Administration (FDA) has concluded its evaluation of the Company´s proprietary drought-tolerant HB4® Wheat.
Upon review of all the safety and regulatory information submitted, the FDA has concluded that it has no further questions regarding the safety of HB4® Wheat, and that it does not raise issues that would require premarket review or approval by FDA. The conclusion of this voluntary consultation program is a key step towards commercial enablement in the United States, which is awaiting approval from the U.S. Department of Agriculture (USDA).
The United States is the fifth largest wheat producer, with an average of 15 million hectares planted every year, and the third largest exporter, holding a key position in the global wheat trade. The FDA’s conclusion follows recent approvals by Brazil, Colombia, Australia, and New Zealand for use in food and feed. HB4® Wheat is commercially authorized for production and consumption in Argentina, where five varieties have been cleared for registration in the current crop season.
HB4® drought-tolerance technology has been shown to increase wheat yields by an average of 20% in water-limited conditions, a key adaptation that favors double-cropping systems, where water management is increasingly critical. Under no-till practices, HB4® Soy-Wheat rotations result in an estimated 1,650 kg of carbon fixed into the soil per hectare per year, compared to positive emissions from conventional soy monoculture.
