All Knowledge & Insights By Date

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...

On June 3, 2025, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) began a public comment period on a draft plant pest risk assessment (PPRA) and draft environmental assessment (EA) regarding a petition from Bayer U.S.-Crop Science seeking a determination of nonregulated status for maize (corn) event MON 95379 that was developed “using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On March 6, 2012, APHIS...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on November 13, 2024, that it added modifications a plant may contain and qualify for exemption from regulations governing movement of organisms modified or produced using genetic engineering because the modifications are achievable through conventional breeding. 89 Fed. Reg. 89569. As reported in our November 16, 2023, blog item, APHIS had proposed five types of modifications: Plants that...

In October 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: SoilCea, sweet orange with improved resistance to citrus greening; Pioneer, corn with fungal disease resistance; GreenLab, Inc., modified corn to produce an enzyme that degrades cellulose and for herbicide resistance to...

On October 2, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the release of a new web-based tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. EPA notes that biotechnology products include plants, animals, and microorganisms developed through genetic engineering or the targeted manipulation of genetic information. According to EPA,...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on May 30, 2024, that it recently reviewed the following plants modified using genetic engineering to determine whether they pose an increased plant pest risk relative to non-modified comparators: Pioneer, corn with insect and herbicide resistance; CoverCress, pennycress with altered product quality; Qi Biodesign, soybean with altered product quality; and Michigan State University, two...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using genetic...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to assist developers with preparing a...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to...