Joint Statement on FDA's Drought Tolerant HB4 Wheat Safety Conclusion

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. u

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 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.