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29 August 2025

APHIS Withdraws Notices Of Intent To Prepare EISs For Two Petitions Seeking Determinations Of Nonregulated Status For Organisms Developed Using Genetic Engineering

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Bergeson & Campbell

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Bergeson & Campbell, P.C. is a Washington D.C. law firm focusing on chemical product approval and regulation, product defense, and associated business issues. The Acta Group, B&C's scientific and regulatory consulting affiliate provides strategic, comprehensive support for global chemical registration, regulation, and sustained compliance. Together, we help companies that make and use chemicals commercialize their products, maintain compliance, and gain competitive advantage as they market their products globally.
On August 18, 2025, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) advised the public that it is withdrawing notices of intent...
United States Environment

On August 18, 2025, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) advised the public that it is withdrawing notices of intent to prepare environmental impact statements (EIS) for two petitions seeking determinations of nonregulated status for organisms developed using genetic engineering. 90 Fed. Reg. 40050. APHIS states that its decision to withdraw the notices of intent is consistent with its July 9, 2025, Program Update that as of that date, APHIS will no longer prepare an analysis under the National Environmental Policy Act (NEPA) to accompany its review of petitions seeking a determination of nonregulated status. APHIS is withdrawing the following notices of intent to prepare EISs for the following petitions:

  • On April 28, 2021, APHIS published a notice of intent (86 Fed. Reg. 22384) to prepare an EIS for Determination of Nonregulated Status for Maize Developed Using Genetic Engineering for Dicamba, Glufosinate, Quizalofop, and 2,4-Dichlorophenoxyacetic Acid Resistance, With Tissue-Specific Glyphosate Resistance Facilitating the Production of Hybrid Maize Seed; and
  • On August 6, 2021, APHIS published a notice of intent (86 Fed. Reg. 43160) to prepare an EIS for Determination of Nonregulated Status for Blight-Tolerant Darling 58 American Chestnut (Castanea Dentata) Developed Using Genetic Engineering.

APHIS notes that two recent developments informed its decision to withdraw the notices of intent. First, on July 3, 2025, USDA issued an interim final rule that revised, moved and republished, or removed portions of USDA's existing NEPA regulations, as well as added new portions to those regulations that apply USDA-wide. 90 Fed. Reg. 29632. The interim final rule requires USDA subcomponents to publish a notice of intent in the Federal Register if a decision is made to withdraw the intent to complete an EIS. Second, on July 9, 2025, APHIS published a Program Update titled "APHIS Announces Update to Practices for Reviewing Petitions Seeking a Determination of Nonregulated Status for Organisms Altered or Produced Through Genetic Engineering." As of July 9, 2025, when evaluating a petition seeking a determination of nonregulated status that meets the information requirements in 7 C.F.R. Section 340.6, APHIS will first determine whether a modified organism is subject to regulation under 7 C.F.R. Part 340 and the plant pest provisions in the Plant Protection Act (PPA). If APHIS determines that a modified organism is unlikely to pose a greater plant pest risk relative to its comparator and is not a plant pest, APHIS will end its review and, because it lacks jurisdiction over the modified organism, APHIS must issue a determination that the modified organism is not subject to 7 C.F.R. Part 340. More information on the Program Update is available in our July 18, 2025, blog item.

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