USDA is deregulating the HB4 drought-tolerant wheat trait from Argentina-based Bioceres Crop Solutions, slightly prying open the door to commercial planting in the United States. 

USDA’s Animal and Plant Health Inspection Service said Tuesday it determined that HB4 wheat is unlikely to pose more plant pest risk than comparable strains, meaning it can be grown and bred safely in the United States. 

The National Association of Wheat Growers and U.S. Wheat Associates welcomed the decision but said it was only the first step of many on the road to commercialization.

“The HB4 trait has tremendous potential – particularly for growers in Kansas who, in 2023 had the smallest crop since 1966 because of drought,” said Kyler Millershaski, a Kansas wheat farmer and board member of NAWG. “We are fortunate to have a robust regulatory process in place by which these – and future – new traits can be brought to market for the benefit of both wheat growers and consumers.”

Wheat growers and advocates believe the trait holds major potential for U.S. producers who have struggled with intense drought but have historically been wary of commercializing biotech wheat until it’s clear that major export markets will accept it. 

Both groups developed a framework for commercializing transgenic wheat traits to meet the industry’s needs, entitled the “Wheat Industry Principles for Biotechnology Commercialization.” The framework details the steps a company must take to earn the support of the U.S. wheat industry. 

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NAWG and USW said they would continue engaging with and monitoring Bioceres’ plans to ensure compliance with the framework. 

“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,” Peter Laudeman, USW director of trade policy, said in a statement.

One of the requirements for U.S. wheat grower commercialization support is that the technology company earn regulatory approval in major importing countries that represent at least 5% of average U.S. wheat export volume. 

FDA gave a green light to the trait in 2022. Additionally, Bioceres has received regulatory approval for food and feed use of the HB4 trait in Nigeria, Brazil, Colombia, Indonesia and South Africa. The company has also applied for approval in other countries. 

Farmers in Argentina and Brazil are growing wheat with the trait, and a field trial is planned in Australia to support regulatory approval there.

APHIS also announced it would deregulate two biotech traits developed by the University of Florida -- a sweet orange and a grapefruit with disease tolerance to citrus greening, also known as huanglongbing (HLB), and confers resistance to antibiotics used to treat the disease.

 



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