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What USDA’s Amfora Soybean Decision Actually Approved

USDA’s 2024 APHIS determination addressed plant-pest risk for Amfora’s described gene-edited soybean. It was not blanket approval for food, feed, or commercial sale.
From TheFinanceBase Team3 min to read
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On March 19, 2024, USDA’s Animal and Plant Health Inspection Service (APHIS) determined that the gene-edited soybean described in Amfora’s request was not subject to the federal rules in 7 CFR part 340. The decision was based on plant-pest risk; it was not blanket government approval for food, feed, or commercial sale. APHIS noted that other authorities, including the FDA and EPA, may have requirements that apply.

What did USDA decide?

APHIS reviewed Amfora’s described soybean and found no plausible pathway by which it would pose an increased plant-pest risk relative to comparator soybean plants. That finding means the soybean, as described in the request, is not subject to 7 CFR part 340. The determination is scoped to that plant and its specified progeny; a material change to the trait, phenotype, or mechanism could require further APHIS review.

APHIS’s letter, signed by Deputy Administrator Bernadette Juarez, states: “APHIS did not identify any plausible pathway by which your modified soybean would pose an increased plant pest risk relative to comparator soybean plants.” Read the APHIS determination.

What was edited in the soybean?

Amfora’s request described edits intended to increase expression of two soybean genes, GmNF-YC4-1 and GmNF-YC4-2. The edits delete certain repressor-binding motifs in the genes’ promoter regions. The intended result was more of the corresponding protein in leaves and seeds. APHIS assessed the soybean’s biology, the trait and its mechanism, and possible effects relevant to plant-pest risk.

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Amfora describes its method as CRISPR gene editing that upregulates a specific gene without introducing foreign DNA. That is the company’s description of its process, not the basis for treating the USDA determination as approval under every regulatory regime. Amfora’s announcement quotes CEO Lloyd Kunimoto saying the decision would “accelerate our ability to scale the sustainable production of protein from soybeans.” That is the company’s characterization of the decision.

How much more protein does Amfora say it has?

Amfora says the gene-edited soybean has approximately 25 percent more protein than conventional soybeans, and that its higher protein level comes with a lower carbohydrate level. The company’s announcement does not give a numeric carbohydrate change. The sources cited here do not include an independent comparative trial report verifying the protein figure, so it should be understood as a company-reported claim rather than an independently established measurement.

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Are Amfora’s announced soy products made from the gene-edited crop?

No. Amfora’s February 22, 2024 announcement of ultra-high-protein soy flour, texturized vegetable protein, and crisps said those products were made from proprietary conventionally bred soybeans—not the gene-edited soybean in the APHIS determination. Amfora reported that these conventionally bred beans had approximately 25 percent more protein than conventional soybeans and that its flour contained more than 60 percent protein. Those company-reported figures describe the conventional-breeding products and should not be conflated with the gene-edited crop’s claimed protein increase. See Amfora’s product announcement.

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Does the decision mean the gene-edited soybean is on the market?

The cited sources do not establish that it is currently commercially available or that seed can be obtained. In May 2024, Agriculture.com reported that breeding, testing, and field work remained, and described an internal commercialization expectation around 2027. That was a dated expectation, not evidence of a later launch. A June 2025 market report still listed the improved-protein soybean as in development and provided no market-access information. Agriculture.com’s May 2024 report and the ProTerra Foundation’s June 2025 report are dated snapshots, not confirmation of the crop’s status after publication.

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What the APHIS determination does—and does not—establish

  • It establishes: APHIS found no plausible pathway for increased plant-pest risk for the soybean described in Amfora’s request, and determined that it was not subject to 7 CFR part 340.
  • It does not establish: blanket approval by every federal agency, completion of all possible regulatory requirements, independent confirmation of Amfora’s protein claim, or current commercial availability.

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