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HB4 Wheat Clears FDA Evaluation

Argentina-based Bioceres Crop Solutions announced that its genetically modified, proprietary, drought-tolerant HB4 wheat variety has cleared an evaluation by the U.S. Food and Drug Administration (FDA) with no further questions regarding its safety.

Clearing this hurdle is a key step toward commercialization in the U.S. - the fifth largest wheat producer with an average 15 million hectares (37 million acres) planted each year, and the third largest global wheat exporter.

Bioceres stated that its HB4 wheat has shown to have yields that are 20 percent higher on average in water-limited conditions - a key factor that favors double-cropping systems. And under no-till practices, HB4 soy-wheat rotations resulted in an estimated 1,650 kilograms of carbon fixed in the soil per hectare per year, compared to emissions from conventional soy monoculture.

The conclusion of the FDA evaluation follows recent approvals in Brazil, Colombia, Australia, and New Zealand for use in food and feed, and follows Bioceres stating that it plans to move forward with efforts to obtain approval to plant and produce its HB4 wheat in Australia.

Despite the majority of the world’s corn and soybeans, which are fed to livestock, being genetically modified, GM wheat, which is more directly consumed by humans in bread, pasta, and other processed foods, has been slower to gain regulatory approvals.


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