Rosario, Argentina (June 27, 2022) - 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 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.
Bioceres Crop Solutions Corp. (NASDAQ: BIOX) is a fully integrated provider of crop productivity technologies designed to enable the transition of agriculture towards carbon neutrality. To do this, Bioceres’ solutions create economic incentives for farmers and other stakeholders to adopt environmentally friendlier production practices. The Company has a unique biotech platform with high-impact, patented technologies for seeds and microbial ag-inputs, as well as next generation crop nutrition and protection solutions. Through its HB4® program, the Company is bringing digital solutions to support growers’ decisions and provide end-to-end traceability for production outputs. For more information, visit here.
Joint Statement on FDA's Drought Tolerant HB4 Wheat Safety Conclusion
Washington, D.C. (June 27, 2022) – Joint Statement by U.S. Wheat Associates (USW) and the National Association of Wheat Growers (NAWG) on the U.S. Food and Drug Administration (FDA) conclusion that it has no further questions regarding the safety of drought tolerant HB4 wheat developed by Bioceres Crop Solutions Corp.
The finding by the FDA is not an approval for this or any other transgenic wheat to be planted for commercial sale in the United States. To date, the HB4 wheat has been approved for commercial production within a closed system in Argentina only. The trait has been approved for human consumption by regulators in Brazil in the form of flour, and in Australia, New Zealand and now in the United States. Bioceres recently announced it will seek approval to plant HB4 wheat in Australia, but it has not announced plans to commercialize the trait in the United States.
With global demand for wheat increasing every year, the need to produce more wheat in sustainable ways is clear. Drought had already reduced world wheat supplies and pushed prices higher before the invasion of Ukraine cut off supplies from the world’s fifth-largest wheat exporting nation. A trait such as drought tolerance in wheat could help wheat growers in increasingly arid regions be more productive and ease food security concerns. Bioceres says the HB4 drought-tolerance technology has been shown to increase wheat yields by an average of 20% in water-limited conditions.
The U.S. wheat industry recognizes the benefits and value that can be created through the prudent application of modern biotechnology. USW and NAWG are guided by jointly approved “Wheat Industry Principles for Biotechnology Commercialization,” which lay out specific steps expected from plant breeding companies if they wish to commercialize transgenic wheat in the United States.
In addition, USW and NAWG support the ability of domestic and overseas customers to make purchases based on their preferences for specific wheat traits, classes, qualities and characteristics.
About the National Association of Wheat Growers:NAWG is the primary policy representative in Washington D.C. for wheat growers, working to ensure a better future for America's growers, the industry, and the general public. NAWG works with a team of 20 state wheat grower organizations to benefit the wheat industry at the national level. From their offices in the Wheat Growers Building on Capitol Hill, NAWG's staff members are in constant contact with state association representatives, NAWG grower leaders, Members of Congress, Congressional staff members, Administration officials, and the public.
About U.S. Wheat Associates: USW's mission is to develop, maintain, and expand international markets to enhance wheat's profitability for U.S. wheat producers and its value for their customers in more than 100 countries. Its activities are made possible through producer checkoff dollars managed by 17 state wheat commissions and cost-share funding provided by USDA's Foreign Agricultural Service. For more information, visit our website at www.uswheat.org.