US Government Approves Bioceres HB4 Wheat Production
The announcement, made today by the company, marks significant progress in the introduction of genetically modified wheat into the North American market
28.08.2024 | 13:48 (UTC -3)
Cultivar Magazine, based on information from Paula Savanti
The United States Department of Agriculture (USDA) has favorably completed the Regulatory Status Review (RSR) for HB4 wheat technology developed by Bioceres Crop Solutions Corp. The announcement, made today by the company, marks a significant step forward for the introduction of genetically modified wheat into the North American market.
After an analysis conducted by the USDA's Animal and Plant Health Inspection Service (APHIS), it was determined that HB4 wheat does not pose an increased risk of plant pests compared to other wheat varieties. With this conclusion, HB4 wheat will not be subject to the regulations established under 7 CFR part 340, which apply to organisms modified or produced through genetic engineering.
This determination opens the doors to the commercial production of HB4 wheat in the United States. The decision complements the favorable evaluation previously obtained from the Food and Drug Administration (FDA) for the use of HB4 wheat in human and animal food. The United States, the fourth largest wheat producer in the world and the largest in the Americas, now joins Argentina, Brazil and Paraguay as countries that have authorized the production of HB4 wheat.
According to Bioceres, HB4 wheat technology has already been approved for use in food and feed in several countries, including Australia, New Zealand, South Africa, Nigeria, Thailand, Indonesia, Colombia and Chile. In Australia, a major wheat-producing region facing increasing water deficits, Bioceres recently obtained a license to conduct field trials, with the aim of collecting data needed for a future production application.
HB4 Wheat Technical Details
HB4 wheat was developed from the Cadenza commercial variety and presents genetic modification that includes the expression of two genes of interest. The first is a variant of the sunflower HaHB4 gene, which encodes a transcription factor involved in the plant's response to environmental stresses. The second is the bar gene, from Streptomyces hygroscopicus, which confers tolerance to the herbicide glufosinate.
The molecular characterization of event IND-00412-7 was carried out using Next Generation Sequencing (NGS) techniques, due to the complexity of the wheat genome, which has approximately 17 billion base pairs and a high rate of repetitive sequences. The HaHB4v gene was identified on chromosome 2D, which was confirmed through segregation analysis of single nucleotide polymorphism (SNP) markers in several populations.