Archives

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...
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: According to...
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...
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: APHIS states that it found these modified plants were unlikely to pose an increased plant pest risk compared to other cultivated plants. As a result, they are not subject to regulation under 7 C.F.R. Part 340. APHIS...
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: APHIS states that it found these modified plants were unlikely to pose an increased plant pest risk compared to other cultivated plants. As a result, they are not subject to regulation under...
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: According to...
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: APHIS states that it found that “these modified plants were unlikely to pose an increased plant pest risk compared to other cultivated plants.” As a result, they are not subject to regulation...