The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on May 19, 2026, that it is extending deregulation to a corn variety, designated as DP51291, developed using genetic engineering for insect-resistance and glufosinate-ammonium tolerance by Pioneer Hi-Bred International, Inc. (Pioneer). APHIS notes that it previously deregulated these traits in another Pioneer corn variety, DP23211 corn. APHIS prepared a Plant Pest Risk Similarity Assessment...
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April 3, 2026
APHIS Seeks Public Comment on Petition to Deregulate Corn Variety Developed Using Genetic Engineering
On March 6, 2026, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it received a request to extend its determination of nonregulated status of Pioneer Hi-Bred International, Inc.’s DP23211 insect-resistant and glufosinate-ammonium-tolerant maize (corn) to DP51291 maize (corn). 91 Fed. Reg. 11028. APHIS states that similar to DP23211 corn, “DP51291 corn was genetically engineered to express the IPD072Aa protein for control of...
April 1, 2026
USDA Deregulates Corn Engineered for Insect Resistance
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2026, that it determined that MON 95275 maize (corn), developed using genetic engineering to produce two insecticidal proteins and a double-stranded Ribonucleic Acid (RNA) transcript to provide protection from feeding damage caused by targeted coleopteran (corn rootworm) insect pests, is no longer considered regulated. 91 Fed. Reg. 14805. APHIS states that its determination is...
March 30, 2026
GAO Report on Engineered Biofertilizers States Current Regulations May Not Be Equipped for Genetically Engineered Microbes
On March 16, 2026, the U.S. Government Accountability Office (GAO) published a report on engineered biofertilizers, which use genetic engineering and combine multiple strains of microbes to enhance their effectiveness. According to GAO, the opportunities of engineered biofertilizers include: Economic benefits: According to GAO, fertilizer costs have increased due to tight global supplies, energy shocks, and trade disruptions. GAO notes that increased crop yields and reduced fertilizer costs...
March 1, 2026
APHIS Seeks Comments on Petitions to Deregulate Certain Products Developed Using Genetic Engineering
In February 2026, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published several petitions seeking a determination of nonregulated status for products developed using genetic engineering. Each petition states that the information provided indicates that the product is unlikely to pose a plant pest risk and therefore should not be regulated. In each case, APHIS prepared a draft plant pest risk assessment (PPRA) to assess the plant pest risk of...
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on September 29, 2025, that it determined that MON 95379 Lepidopteran-Protected Maize (corn), which was developed using genetic engineering to produce two insecticidal proteins to protect against feeding damage caused by target lepidopteran pests, is no longer considered regulated. 90 Fed. Reg. 46546. APHIS states that its determination is based on its evaluation of information and data...
October 2, 2025
USDA’s Spring 2025 Unified Agenda Includes Rules Regarding Biotechnology Products and Bioengineered Foods
On September 4, 2025, the Office of Management and Budget (OMB) published the Trump Administration’s Spring 2025 Unified Agenda. The U.S. Department of Agriculture’s (USDA) Unified Agenda includes the following Animal and Plant Health Inspection Service (APHIS) rulemakings: Regaining Lost Efficiencies for Products of Biotechnology: According to the Unified Agenda item, this interim rule will create exemptions from USDA’s regulations for plants and microbes that are already subject to U.S....
October 1, 2025
APHIS Deregulates Moth Orchid Genetically Engineered to Produce a Blue-Purple Flower Color
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...
On August 18, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) advised the public that it is withdrawing notices of intent to prepare environmental impact statements (EIS) for two petitions seeking determinations of nonregulated status for organisms developed using genetic engineering. 90 Fed. Reg. 40050. APHIS states that its decision to withdraw the notices of intent is consistent with its July 9, 2025, Program Update that as of that date,...
August 7, 2025
APHIS Seeks Comment on Petition to Deregulate Corn Developed Using Genetic Engineering
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on July 8, 2025, that it has received a petition from Bayer CropScience seeking a determination of nonregulated status for MON 95275 maize (corn) that has been developed using genetic engineering to produce two insecticidal proteins and a double-stranded RNA transcript to provide protection from feeding damage caused by targeted coleopteran (corn rootworm) insect pests. 90 Fed. Reg. 30035....
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on July 9, 2025, that it is updating its practices for reviewing petitions seeking a determination of nonregulated status for organisms altered or produced through genetic engineering (modified organisms) under 7 C.F.R. Part 340. According to APHIS, it is making these updates to ensure its petition process aligns with recent developments related to the National Environmental Policy Act...
On June 6, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it has prepared a revised draft environmental impact statement (EIS) and revised draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for blight-tolerant American chestnut (Castanea dentata) from the State University of New York College of...
July 1, 2025
APHIS Seeks Comment on Petition to Deregulate Orchid Developed Using Genetic Engineering
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...
March 31, 2025
APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going Forward
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...
December 3, 2024
APHIS Revises and Adds Exemptions for Plants Modified or Produced through Genetic Engineering
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...
October 2, 2024
EPA, FDA, and USDA Release Tool to Help Companies Developing Microbial Biotechnology Products Navigate Regulatory Landscape
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...
April 12, 2023
APHIS Seeks Comment on Draft Environmental Documents for Deregulation of Corn Developed Using Geneti
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...
March 23, 2023
APHIS Accepting Public Comments on Draft Guide for Submitting Permit Applications for Microorganisms
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...