The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is deregulating Ishihara Sangyo Kaisha, Limited (Ishihara) Phalaenopsis orchid (ISK-311NR-4) developed using genetic engineering to produce blue-purple flowers. After a thorough review, APHIS has determined that ISK-311NR-4 is unlikely to pose a greater plant pest risk than the unmodified comparator and therefore is no longer subject to their regulation governing the introduction of certain organisms developed using genetic engineering.
© United States Department of Agriculture
The determination is based on the evaluation of several key elements, including the information and data that Ishihara submitted in its petition for deregulation. Additionally, available scientific data were thoroughly reviewed to support the decision-making process. Public comments, which were received in response to the June 4, 2025, Federal Register notice announcing the availability of the petition and plant pest risk assessment (PPRA), also played a crucial role in shaping the final determination.
The FDA are publishing the Determination of Nonregulated Status, final PPRA, and response to public comments on the PPRA. These documents support APHIS' review and analysis of any potential plant pest impacts associated with deregulating Ishihara Sangyo Kaisha, Ltd. Phalaenopsis orchid.
