USDA Announces Deregulation of Orchid Developed Using Genetic Engineering

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Field of Blue Orchids

WASHINGTON, September 3, 2025—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 our regulation governing the introduction of certain organisms developed using genetic engineering.

Our determination is based on our evaluation of the following:

  • Information and data Ishihara submitted in its petition for deregulation
  • Available scientific data
  • Public comments received in response to the June 4, 2025, Federal Register notice announcing the availability of the petition and plant pest risk assessment (PPRA) 

We 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. 

These documents and the Federal Register notice will be available on the Regulations.gov website Thursday, September 4, 2025: https://www.regulations.gov/docket/APHIS-2025-0005/document.

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