U.S. Wheat Associates (USW) commends the U.S. Department of Agriculture (USDA) for its thorough, science-based process resulting in the deregulation of the HB4® drought-tolerant trait from Bioceres Crop Solutions announced on August 27, 2024. The farmer leaders of USW are confident that the HB4® trait has the potential to deliver significant producer and consumer benefits.

Although USDA’s ruling clears the regulatory pathway for cultivation of HB4® wheat in the United States, there are several additional steps needed before those benefits are realized and HB4® is grown commercially in the United States. These include the need to conduct closed-system field trials prior to commercialization. USW will continue monitoring Bioceres’ commercialization plans to ensure careful stewardship and alignment with the “Wheat Industry Principles for Biotechnology Commercialization” developed jointly with the National Association of Wheat Growers (NAWG).

“Wherever wheat is grown in the world, drought takes its toll on yields and quality, so an innovation like HB4 holds a lot of interest for growers like me,” said USW Past Chairman and Okarche, Okla., wheat grower Michael Peters. “With global demand for wheat hitting new records almost every year, there is concern about variable production. A drought-tolerant trait offers more stable, sustainable production. At the same time, it is important that customers who have specific purchase preferences understand the industry supports their ability to purchase the type of wheat they want. That remains our policy after more than 16 years.”

In line with the principles for commercialization, USW and NAWG support for HB4® and any transgenic wheat commercialization is linked to the technology company receiving regulatory approval in major importing countries that represent at least five percent of average U.S. wheat export volume.

In addition to the U.S. Food and Drug Administration accepting the safety of the HB4® trait in 2022, Bioceres has received regulatory approval for food and feed use in Nigeria, Brazil, Colombia, Indonesia, and South Africa, and has applied for approval in several other countries. Farmers are currently growing wheat with the HB4® trait in Argentina and Brazil. Bioceres also plans field trials in Australia with the intent to gain regulatory approval for cultivation there.

“Our organization has established a productive dialogue with Bioceres, and we appreciate that the company understands the importance of our joint wheat industry principles,” said USW Director of Trade Policy Peter Laudeman. “I have travelled with growers to Argentina to see HB4 wheat in the field and they were impressed by its performance. We believe the trait represents good science with positive potential to improve food security in a more sustainable way.”

Laudeman noted that beyond the announcement of the competed regulatory review, it will still take years for Bioceres to complete the additional steps needed to successfully commercialize wheat with the HB4® trait in the United States.

“There is still a lot of ground to cover with this technology and our organization will stay actively engaged in the process on behalf of our farmers and overseas customers,” Laudeman said, “We appreciate the commitment that Bioceres is making to working with its wheat industry partners to ensure robust stewardship of this technology prior to commercial release.”

More information about Bioceres, HB4®, and U.S. wheat organization positions on transgenic wheat commercialization is available at:

• Wheat Industry Principles for Biotechnology Commercialization
• Wheat Industry Biotechnology Position Statement
• Joint Statement on FDA’s Drought Tolerant HB4 Wheat Safety Conclusion
• Bioceres Crop Solutions Announces Brazil’s Regulatory Approval of Drought Tolerant HB4® Wheat for Commercialization and Cultivation
• USW Discusses HB4 Wheat with Bioceres
• Genetically Modified Wheat Could Provide Drought Relief