The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it received a petition from Ishihara Sangyo Kaisha, Limited seeking a determination of nonregulated status for ISK-311NR-4 Phalaenopsis (moth orchid) that has been developed using genetic engineering to produce a blue-purple flower color. 90 Fed. Reg. 23666. According to APHIS, the petition states that the information provided indicates that ISK-311NR-4 Phalaenopsis is unlikely to pose a plant pest risk and therefore should not be regulated under APHIS' regulations in 7 C.F.R. Part 340. As part of APHIS' decision-making process regarding the organism's regulatory status, it prepared a draft plant pest risk assessment (PPRA) to assess the plant pest risk of the organism and a draft environmental assessment (EA) to evaluate potential impacts on the human environment that may result if the petition request is approved. APHIS states that its draft PPRA compared the pest risk posed by the ISK-311NR-4 Phalaenopsis with that of the unmodified variety from which it was derived. The draft PPRA concluded that ISK-311NR-4 Phalaenopsis is unlikely to pose an increased plant pest risk compared to the unmodified moth orchid. The draft EA evaluated potential impacts that may result from the commercial production of ISK-311NR-4 Phalaenopsis, including potential impacts on conventional moth orchid production; the acreage and area required for U.S. moth orchid production; agronomic practices and inputs; the physical environment; biological resources; human health and worker safety; and animal health and welfare. APHIS is making the petition, draft PPRA, and draft EA available for public review and comment. Comments are due August 4, 2025.
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