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In a key step, developer says FDA finds GMO wheat is safe to eat

After a generation on the sidelines, the wheat industry may be on the cusp of joining the era of agricultural biotechnology. Crop developer Bioceres said on Monday that the FDA has determined during consultations that its HB4 wheat variety, genetically modified for drought- and herbicide-tolerance, was safe to eat.

“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,” said Bioceres. “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 Argentine company already holds approval from food-safety regulators in Argentina, Brazil, Australia and New Zealand.

The wheat industry has hesitated to adopt genetic engineering out of concern that consumers might reject GE wheat. There was vocal skepticism to the introduction of GMO corn and soybeans in the mid-1990s. Those are feed grains, used in livestock, dairy and poultry production. By contrast, wheat is a food crop and is directly consumed as bread, pasta, bakery products and breakfast cereal.

“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,” said the U.S. wheat industry. “Bioceres recently announced it would seek approval to plant HB4 wheat in Australia but it has not announced plans to commercialize the (wheat) in the United States.”

Australia, Argentina and the United States are among the half-dozen leading wheat exporters. Last year, Bioceres said it would focus on winning approval for key wheat importing nations before it put its GMO seed on the market for cultivation.

An FDA spokesperson was not immediately available for comment. Its consultation process is voluntary and the agency said “developers of new plant varieties routinely participate in this program before bringing food from a new genetically engineered plant to market.”

U.S. wheat groups said prudent application of agricultural biotechnology could deliver benefits. “A trait such as drought tolerance in wheat could help wheat growers in increasingly arid regions be more productive and ease food security concerns,” they said in a joint statement. The National Association of Wheat Growers and export-promoter U.S. Wheat Associates previously said they would support commercialization of transgenic wheat “after thorough review and development of a commercialization plan that facilitates commercialization with minimal market disruptions.”

If GMO wheat is authorized for commercial sale, it must not interfere with marketing of traditionally bred wheat, in the view of U.S. wheat groups. “We support the ability of our customers to make purchases based on their preferences for specific traits, classes, qualities and characteristics,” they said in a statement of principles for biotechnology.

Bioceres says its GMO wheat “has been shown to increase wheat yields by an average of 20% in water-limited conditions.” A double-crop rotation of HB4 wheat and soybeans locks carbon into the soil, it said.

Produced with FERN, non-profit reporting on food, agriculture, and environmental health.
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