The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced on July 9, 2025, that it will no longer conduct environmental analyses under the National Environmental Policy Act (NEPA) when reviewing petitions for determination of nonregulated status for organisms developed using genetic engineering (GE) pursuant to 7 C.F.R. part 340. This policy change is poised to streamline the path to nonregulated status for qualifying GE organisms.
APHIS Deregulation Petitions No Longer Subject to NEPA Review
A petition to USDA-APHIS for determination of nonregulated status (Regulatory Status Review) allows petitioners to demonstrate that an organism developed through genetic engineering is not a plant pest and should no longer be regulated by the biotechnology regulations at 7 C.F.R. part 340. APHIS has historically conducted environmental assessments in accordance with NEPA when making determinations for nonregulated status.[1] NEPA is an environmental review statute that requires agencies to consider the environmental impacts of major federal actions. APHIS’s NEPA implementing procedures identified determinations of nonregulated status as “[a]ctions normally requiring environmental assessments.”[2] As part of the determination process, APHIS invited petitioners to provide information relevant to NEPA analyses, including information relevant to agronomic practices that affect the environment and a potential socioeconomic analysis.[3]
On July 3, 2025, the Department of Agriculture rescinded and revised its NEPA implementing regulations, including a wholesale revocation of APHIS’s NEPA implementing procedures. Shortly after, on July 9, APHIS announced that it will no longer prepare NEPA analyses to accompany its reviews of petitions seeking determinations of nonregulated status.
APHIS asserts that once it concludes that a GE organism is not a plant pest under 7 C.F.R. part 340, it lacks the statutory jurisdiction to regulate the organism further. Consequently, any environmental review beyond the plant pest risk assessment is, in the agency’s view, not required because APHIS has no authority to mitigate any other identified environmental impacts. Citing the Supreme Court’s decision in Seven Cnty. Infrastructure Coal. v. Eagle Cnty., which clarified that agencies are not required to analyze projects outside of their direct authority, APHIS concluded that “there is no role for NEPA in the agency’s response to a petition for determination of nonregulated status because APHIS has no ability to consider any factors or environmental impacts beyond the factual and scientific information that is relevant to determining whether an article is a ‘regulated article’ under 7 C.F.R. § 340.1.”
A Period of Upheaval for NEPA
NEPA has undergone legislative, regulatory, and judicial changes in recent years that together significantly diminish the strength of this cornerstone environmental law.
In 2023, Congress amended NEPA through the Fiscal Responsibility Act,[4] clarifying that federal agencies are not required to prepare environmental analyses if the agency does not have authority to take environmental factors into consideration in determining whether to take the proposed action. Two courts subsequently concluded that the White House Council on Environmental Quality (CEQ) does not have the legal authority to promulgate regulations implementing NEPA,[5] leading to a recission of all CEQ NEPA regulations.[6] A May 2025 Supreme Court decision in Seven Cnty. Infrastructure Coal. v. Eagle County additionally narrowed the scope of required considerations in NEPA Environmental Impact Statements (EIS) and emphasized that deference should be given to agencies in determining the scope and contents of an EIS.[7] Finally, on July 4, 2025, the One Big Beautiful Bill Act[8] was signed into law, creating a fee-based program for expedited NEPA review of projects.
Within this shifting NEPA landscape, APHIS is not alone in reconsidering its obligations under NEPA. On June 30, 2025, federal agencies including the Federal Energy Regulatory Commission, Department of Energy, Department of the Interior, and Department of Transportation revoked their regulations governing their review of proposed projects under NEPA. Some agencies are proposing new regulations, while others have chosen to issue nonbinding guidance.
What’s Next
Effective July 9, when evaluating a petition seeking a determination of nonregulated status, APHIS now first determines whether a modified organism is subject to regulation. If APHIS determines that a modified organism is not a plant pest, APHIS will end its review without undertaking a NEPA environmental assessment. The termination of NEPA reviews of petitions for deregulation will likely speed up the consideration of such petitions and reduce the information required for the agency’s review.
[1] A court ruling in 2024 vacated certain APHIS rules under 7 C.R.F. part 340, including the regulations enabling Regulatory Status Review. The ruling caused APHIS to revert to its pre-2020 legacy framework for permitting and deregulation of genetically engineered (GE) organisms. See our prior blog posts APHIS Reinstates Legacy Biotechnology Regulations: Implications for CRISPR-Edited Plants and APHIS Reinstates Legacy Biotechnology Regulations: Implications for CRISPR-Edited Plants for more information. In March 2025, APHIS reinstated the Regulatory Status Review process.
[2] 7 CFR § 372.5(b)(7) (July 3, 2025).
[3] See USDA APHIS BRS, Petitioner User Guide 5 (Feb., 19, 2025).
[4] Pub. L. No. 118-5, § 321(b).
[5] Marin Audubon v. Federal Aviation Administration, No. 23-1067 (D.C. Cir. 2024); Iowa v. Council on Envtl. Quality, 1:24-cv-089 (D.N.D. Feb. 3, 2025).
[6] After the judicial determinations about CEQ’s authority, President Trump signed an Executive Order (EO) revoking the 1977 EO that had directed CEQ to issue NEPA regulations. In accordance with the new EO, CEQ has rescinded its NEPA regulations and is issuing guidance to agencies in alignment with the administration’s regulatory priorities.
[7] No. 23-975, 605 U.S. ___ (2025).
[8] Public Law No. 119-21.
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