HB4 Wheat Receives USFDA Clearance After Evaluation

The US Food and Drug Administration (USFDA) in the United States has completed its evaluation of Bioceres Crop Solutions Corp's proprietary drought-tolerant HB4 Wheat. Bioceres, a crop productivity solutions provider, has revealed that after reviewing all of the safety and regulatory information submitted, the FDA has concluded that it has no further concerns about the safety of HB4 Wheat and that it does not raise issues that would necessitate FDA premarket review or approval.

"The completion of this voluntary consultation programme is a critical step toward commercial enablement in the United States, which is awaiting approval from the United States Department of Agriculture (USDA)," Bioceres says.

According to the company, the United States is the fifth largest wheat producer, with an average of 15 million hectares planted each year, as well as the third-largest exporter, with a significant role in the global wheat trade.

The FDA's decision follows recent approvals for use in food and feeds by Brazil, Colombia, Australia, and New Zealand. In Argentina, where five varieties have been cleared for registration in the current crop season, HB4 Wheat is commercially authorized for production and consumption. Argentina became the first country to grant this permission in October 2020.

According to Bioceres, HB4 drought-tolerance technology has been shown to increase wheat yields by an average of 20% in water-limited conditions, a key adaptation that favours double-cropping systems where water management is becoming increasingly important.

"Compared to positive emissions from conventional soy monoculture, HB4 Soy-Wheat rotations result in an estimated 1,650 kg of carbon fixed into the soil per hectare per year under no-till practices," the company says.

Drought-resistant HB4 Wheat is a patented seed technology developed by Trigall Genetics, a joint venture between Bioceres and Florimond Desprez, a world leader in wheat genetics.

Field trials of HB4 Wheat have been ongoing since 2009, and since 2013, Bioceres and Florimond Desprez have invested heavily in breeding and Phase II regulatory activities. HB4 not only reduces production losses during drought conditions, but it also allows for double cropping, which rotates soy and wheat seasonally, an environmentally friendly farming system that would otherwise be limited by water availability.

A sharecropping system enabled by HB4 seeds captures more carbon than conventional growing practices when combined with soil regenerative practices such as no-till farming. HB4 is combined with top-selling wheat germplasms and marketed as EcoWheat, which also includes other Bioceres biotechnologies such as Rizoderma, a biofungicide, and other health and growth-promoting microorganisms found in the company's integrated seed products.