Archives

December 17, 2025

APHIS Biotechnology Regulatory Services Reschedules Stakeholder Meeting for February 26, 2026

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced on December 16, 2025, that its Biotechnology Regulatory Services (BRS) has rescheduled its annual stakeholder meeting for February 26, 2026. The meeting will be held in-person at the National Agricultural Library, 10301 Baltimore Avenue Beltsville, Maryland, with an option for virtual attendance. According to APHIS, attendees will receive updates about: Highlights from fiscal year 2025; Looking...
October 6, 2025

APHIS Deregulates Corn Developed Using Genetic Engineering to Resist Certain Pests

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...
September 29, 2025

Registration Opens for APHIS BRS Stakeholder Meeting on November 13, 2025

Registration has opened for the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) annual stakeholder meeting on November 13, 2025. The meeting will be held in person at the National Agricultural Library (10301 Baltimore Avenue, Beltsville, Maryland 20705), with an option to attend virtually. The agenda includes the following topics: Fiscal year 2025 highlights; Restructuring changes; Petitions; Permits and...
September 11, 2025

USDA Extends Comment Period on Reorganization Plan to September 30, 2025

As reported in our August 5, 2025, blog item, the U.S. Department of Agriculture (USDA) announced on August 1, 2025, an opportunity for stakeholders to provide feedback on USDA’s reorganization plan, as outlined in the July 24, 2025, memorandum issued by U.S. Secretary of Agriculture Brooke L. Rollins. According to the memorandum, the Animal and Plant Health Inspection Service (APHIS) centers “will remain at current locations as they are located in USDA hub locations.” The memorandum does...
August 27, 2025

APHIS Withdraws Notices of Intent to Prepare EISs for Two Petitions Seeking Determinations of Nonregulated Status for Organisms Developed Using Genetic Engineering

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....
August 5, 2025

USDA Seeks Public Comment on Reorganization Plan

The U.S. Department of Agriculture (USDA) announced on August 1, 2025, the opening of a 30-day public comment period for stakeholders to provide feedback on USDA’s reorganization plan, as outlined in the July 24, 2025, memorandum issued by U.S. Secretary of Agriculture Brooke L. Rollins. According to the press release, the reorganization proposal reflects President Trump’s commitment to relocate federal agencies beyond the national capital region, reduce bureaucracy, and strengthen USDA’s...
July 18, 2025

APHIS Updates Practices for Reviewing Petitions Seeking a Determination of Nonregulated Status for Organisms Altered or Produced through Genetic Engineering

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...
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...
February 28, 2025

APHIS Will Begin Accepting Petitions for Nonregulated Status on March 3, 2025

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2025, that it will begin to accept petitions for nonregulated status according to APHIS biotechnology regulations at 7 C.F.R. Part 340 (2019) on March 3, 2025. APHIS notes that its biotechnology regulations enable developers to petition for a determination that an “article” is not regulated. The petition process applies only to plants that meet the regulatory definition...
December 5, 2024

District Court Grants Summary Judgment in Part to Plaintiffs, Vacating and Remanding Final SECURE Rule to USDA

On December 4, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it acknowledges the U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacating USDA’s May 2020 final rule for organisms developed using genetic engineering. National Family Farm Coalition, et al. v. Vilsack (No. 3:21-cv-05695-JD). As reported in our May 18, 2020, memorandum, the final Sustainable, Ecological,...
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...
November 7, 2024

APHIS Releases Final Guide to Submitting Reports and Notices in APHIS eFile and Response to Comments

On November 6, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the completion of the final version of the Guide to Submitting Data for Reports and Notices in APHIS eFile and the Response to Comments: Guide to Submitting Data for Reports and Notices in APHIS eFile. In October 2023, to clarify and streamline its biotechnology regulations further, BRS published for comment a draft guide to...
November 4, 2024

APHIS Issues RSR Responses for Modified Orange, Corn, Almond, and Tomato Plants

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...
August 28, 2024

APHIS Issues Regulatory Status Review Responses to University of Florida and Bioceres Crop Solutions

On August 27, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it recently reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: University of Florida, two submissions, a sweet orange and a grapefruit with disease tolerance to citrus greening, also called Huanglongbing (HLB); and Bioceres Crop Solutions, wheat with...
July 8, 2024

APHIS Issues Regulatory Status Review Responses

On June 27, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it recently reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: Plants modified for altered product quality: CoverCress, two pennycresses; Hjelle Advisors, rice; and Toolgen, soybean; Plant modified for increased yield: Inari, two soybeans; Plant modified...
June 25, 2024

APHIS RFI Will Seek Comments on Options for Reducing Regulations for Modified Microbes

The U.S. Department of Agriculture’s (USDA) Animal and Health Inspection Service (APHIS) announced on June 25, 2024, that it will soon publish a request for information (RFI) in the Federal Register, beginning a 60-day public comment period. According to APHIS, the RFI will explore options to reduce the regulatory burden for modified microbes. APHIS states that it developed the RFI in response to stakeholder requests. Specifically, APHIS will request comments to help identify: Potential...
June 5, 2024

APHIS Issues RSR Responses for Modified Corn, Pennycress, Soybean, and Potato Plants

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...