USDA finds HB4 drought-tolerant wheat outside its biotech plant regulations

What was demonstrated
USDA's Animal and Plant Health Inspection Service (APHIS) completed a Regulatory Status Review of HB4 wheat, a genetically modified wheat developed by Bioceres Crop Solutions with drought tolerance and herbicide resistance. APHIS concluded that the wheat is unlikely to pose an increased plant pest risk compared with other cultivated plants, so it is not subject to the regulations in 7 CFR part 340. According to the ISAAA summary, the same exemption covers progeny from crosses with other modified and non-modified plants. The regulator's decision is about plant pest risk. It does not report drought performance, yield or food safety data.
Why it matters
This is a US federal step that removes one set of biotech plant regulations from HB4 wheat. It does not show that the wheat performs better in drought in real fields, because the drought and yield claims come from the developer.
Caveats
- The decision assesses plant pest risk only. It does not test drought performance, yield or food safety.
- Drought and yield claims for HB4 wheat come from the developer, Bioceres Crop Solutions, and were not part of the regulator's statement. The developer's announcement gives no yield or drought figures.
- According to the ISAAA summary of the APHIS notice, the wheat may still be subject to APHIS plant protection permit or quarantine requirements, and other authorities such as the EPA and FDA may also apply.
- The sources reviewed give no commercial planting or seed availability date, so this decision does not mean the wheat is on sale to farmers.
Technology profiles
Sources
- government report
APHIS Issues Regulatory Status Review Responses: University of Florida and Bioceres Crop Solutions
USDA Animal and Plant Health Inspection Service (APHIS), 2024. - company announcement
Bioceres Crop Solutions Receives Green Light for Cultivation of Drought Tolerant HB4 Wheat in the United States
Bioceres Crop Solutions, 28 Aug 2024. - news
USDA APHIS Releases Regulatory Status Review on HB4 Wheat
ISAAA Crop Biotech Update, 4 Sept 2024.
Last reviewed 22 Oct 2026.