Bioceres said the voluntary consultation program is a "key step towards commercial establishment in the United States" and that it is awaiting USDA approval

US consumers need to watch out for GM wheat appearing (with no meaningful labelling) on store shelves.
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Argentina's Bioceres says its GMO wheat gets key OK from US FDA

By Jorgelina Do Rosario and Tom Polansek
Reuters, June 27, 2022
https://www.reuters.com/markets/commodities/argentinas-bioceres-says-its-gmo-wheat-gets-key-ok-us-fda-2022-06-27/

The US Food and Drug Administration concluded a review of Argentine biotechnology firm Bioceres' (BIOX.BA) genetically modified (GMO) wheat without further questions, a "key step" to commercializing it in the United States, the company said on Monday.

While corn and soy crops used predominantly to feed livestock are commonly planted with GMO seeds, consumers have long opposed GMO wheat for human consumption.

Bioceres says sentiment is changing with food prices soaring due to the Ukraine war, as genetically modified crops can survive drought and pests, reducing the risk of famine. [GMW: Must be a joke, surely? No evidence provided.]

The FDA did not respond to a request for comment. The drought-resistant HB4 wheat would still need to be cleared by the U.S. Department of Agriculture.

The FDA oversees the safety of food from new GMO crops before they enter the market, while the USDA reviews the impact on agriculture and the environment.

The FDA's voluntary consultation process relies on crop developers' own data, consumer advocates said.

The process can give comfort to food companies that may one day use the wheat, though the FDA relies on the company's position that it is safe, said Greg Jaffe, biotechnology project director for the nonprofit Center for Science in the Public Interest.

"It's better than nothing," Jaffe said.

Bioceres said the voluntary consultation program is a "key step towards commercial establishment in the United States" and that it is awaiting USDA approval.

The USDA's Animal and Plant Health Inspection Service, which regulates genetically engineered crops, said it does not have a petition from Bioceres.

The USDA could exempt a GMO crop from regulatory review in as little as 120 days if officials determine it does not pose an increased risk for plant pests, said Bill Freese, scientific director for the Center for Food Safety, an advocacy group.

Otherwise, a review could take more than a year, he said.

Bioceres said it plans to seek planting approvals next year in Australia, which has approved the sale and use of foods that contain HB4 wheat. Brazil is testing the variety.


Reporting by Jorgelina do Rosario in London and Caroline Stauffer and Tom Polansek in Chicago; Writing by Adam Jourdan and Tom Polansek, editing by Deepa Babington