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USDA’s Animal and Plant Health Inspection Service (APHIS) concluded on August 27, 2024, that the Bioceres/Trigall HB4 wheat it reviewed was unlikely to pose an increased plant-pest risk compared with non-modified wheat. APHIS said it may be safely grown and bred in the United States from that specific risk perspective. The decision did not mean the wheat was already approved for sale, commercially available, or cleared on every food-safety, trade, and market question. U.S. Wheat Associates said more steps, including closed-system field trials, remained before commercial cultivation; the cited public statements do not establish whether those trials have since been completed.
What APHIS decided about HB4 wheat
APHIS reviewed request 22-199-01rsr, submitted by Trigall Genetics SA for wheat (Triticum aestivum). Its Regulatory Status Review response, dated August 27, 2024, concluded that the modified wheat was not subject to regulation under 7 CFR part 340. APHIS stated: “From a plant pest risk perspective, this modified plant may be safely grown and bred in the United States.”
That wording is deliberately bounded. It describes APHIS’s plant-pest-risk determination for the wheat in the request; it is not a general finding that the crop has no risks of any kind or that every agency, buyer, grower, or trading partner has accepted it.
The traits APHIS reviewed
The request described two traits: increased drought tolerance and resistance to glufosinate. The drought-tolerance trait is associated with expression of HaHB4, a sunflower transcription factor involved in plant responses to desiccation. The herbicide-resistance trait uses bar/PAT, an enzyme that converts L-phosphinothricin into a non-phytotoxic form, conferring resistance to glufosinate. These descriptions identify the intended traits and mechanisms; they do not establish a particular yield advantage or field performance in U.S. growing conditions.
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What “pending trials” means—and what is not known
APHIS had completed its review by August 27, 2024; the field-trial steps were separate from that determination. On the same date, U.S. Wheat Associates said that closed-system field trials were among the additional steps needed before HB4 wheat would be grown commercially in the United States. Bioceres later described moving forward with non-regulated field activities for product development and commercialization.
Those dated statements support a distinction between the completed regulatory response and subsequent development work. They do not establish the present status of the trials or whether commercial cultivation has begun. It would therefore be inaccurate either to say APHIS was still awaiting the trials for its 2024 decision or to treat that decision as proof that the crop is now commercially available.
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Which questions the APHIS decision did and did not settle
Federal biotechnology oversight is divided by subject. USDA describes FDA as having primary responsibility for human food and animal-feed safety, EPA as regulating pesticides including plant-incorporated protectants, and APHIS as addressing certain plant-health risks. The 2024 wheat response should be read within APHIS’s remit, not as a substitute for every other regulatory or commercial determination.
| Question | What the cited record establishes |
|---|---|
| Plant-pest risk under APHIS review | APHIS’s August 27, 2024 response said the wheat was not subject to regulation under 7 CFR part 340 and may be safely grown and bred from a plant-pest-risk perspective. |
| Human food and animal-feed safety | Not resolved by the APHIS plant-pest-risk conclusion; USDA identifies FDA as having primary responsibility for these areas. |
| Pesticide regulation | Not resolved by the APHIS conclusion; USDA identifies EPA as regulating pesticides, including plant-incorporated protectants. |
| Field development and commercial readiness | U.S. Wheat Associates described further steps, including closed-system field trials, before U.S. commercial cultivation. The cited statements do not establish their current completion status. |
| Market acceptance and trade | Not settled by APHIS’s plant-pest-risk response. |
How the later change to USDA’s biotechnology rule affects the response
APHIS reports that a federal court vacated USDA’s May 2020 rule on December 2, 2024. The agency says responses to Regulatory Status Reviews, confirmation responses, and active permits issued before that date remain valid. APHIS also says it restarted permitting and “Am I Regulated” processes in January 2025, notification intake in February 2025, and petition intake in March 2025. Under APHIS’s stated position, the court action did not automatically void the 2024 wheat response.
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What USDA’s bioengineered-food list does—and does not—show
USDA’s Agricultural Marketing Service (AMS) maintains the Bioengineered Foods List for disclosure and recordkeeping purposes. Wheat did not appear among the crop entries on the reviewed list page, but absence from the list alone does not establish that a particular food is not bioengineered or exempt from disclosure. AMS says records showing that a food being sold is bioengineered can still trigger disclosure obligations.
An AMS notice dated April 2, 2024, solicited information on whether wheat should be added to the list. That notice documents a request for information at that time; it does not establish whether the list was subsequently updated.
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Why Argentina’s HB4 wheat figures do not answer the U.S. question
USDA’s Foreign Agricultural Service reported that almost 50,000 hectares of HB4 wheat were planted in Argentina in the 2022/23 season. That is a historical Argentina figure, not U.S. acreage or a current measure of commercial availability. The report described production under special contracts and identity-preservation measures overseen by Argentina’s National Seed Institute (INASE), intended to limit the movement of genetically engineered material into other production or export channels. It said Bioceres planned close-loop management and that HB4 seed and flour would not be openly commercialized in the system described.
The same report characterized Bioceres’ “HB4 Generation” as an identity-preserved, pre-commercial program for Argentine farmers to test the technology. It is not evidence of an open U.S. seed offer or retail availability.
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