The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on September 4, 2025, that it determined that ISK-311NR-4 phalaenopsis (moth orchid), which was developed using genetic engineering to produce a blue-purple flower color, is no longer considered regulated. 90 Fed. Reg. 42737. APHIS states that its determination is based on its evaluation of information and data Ishihara Sangyo Kaisha, Limited submitted in its petition for a determination of nonregulated status, available scientific data, the plant pest risk assessment, and public comments received in response to a previous notice announcing the availability of the petition for nonregulated status and a draft plant pest risk assessment. Although APHIS prepared and published a draft environmental assessment (EA), APHIS notes that on July 9, 2025, it issued a Program Update entitled “APHIS Announces Update to Practices for Reviewing Petitions Seeking a Determination of Nonregulated Status for Organisms Altered or Produced Through Genetic Engineering.” In the Program Update, APHIS announced that it will no longer prepare a National Environmental Policy Act analysis to accompany its review of petitions seeking a determination of nonregulated status. Therefore, consistent with the July 9, 2025, Program Update, APHIS terminated work on the EA. APHIS’ written determination and supporting documents are available in Docket No. APHIS-2025-0005. According to the Federal Register notice, the change in regulatory status was recognized as of September 2, 2025.
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