FDA clears transgenic wheat, but doesn’t authorize planting | TheFencePost.com
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FDA clears transgenic wheat, but doesn’t authorize planting

The Food and Drug Administration has notified Bioceres Crop Solutions Corp. that it has concluded its evaluation of the company’s proprietary drought-tolerant HB4 wheat, 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.

But the National Association of Wheat Growers, which represents farmers, and U.S. Wheat Associates, an export group, pointed out in a news release that “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.”

NAWG and U.S. Wheat Associates said Bioceres has announced it will seek approval to plant HB4 wheat in Australia, but it has not announced plans to commercialize it in the United States. In its news release, however, Bioceres said, “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.”



Genetic modification of wheat is controversial. Farmers see the advantages that growers of corn, soybeans and cotton have found in the genetic modification of those plants, but consumer leaders have noted that wheat would be used for flour, which would be directly consumed by people in the form of bread and pasta. In the past, some foreign customers for U.S. wheat and durum have said they would not import wheat from the United States if genetically modified wheat is commercially planted in the United States.

NAWG and USW said, “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.”



NAWG and USW also noted that they 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 said they support the ability of domestic and overseas customers to make purchases based on their preferences for specific wheat traits, classes, qualities and characteristics.

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