Archives

August 25, 2025

EPA Releases White Paper on Determining the Absence of Novel Proteins in the Saliva of GE Mosquitoes for Mosquito Control

The U.S. Environmental Protection Agency (EPA) announced on August 21, 2025, the availability of and solicited public comment on materials that are being submitted to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) for peer review on “Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control.” 90 Fed. Reg. 40829. The white paper, charge questions, background documents, and related...
July 26, 2025

EPA Seeks Nominations of Peer Reviewers to Evaluate Design Considerations for Genetically Engineered Mosquitoes

The U.S. Environmental Protection Agency (EPA) announced on July 23, 2025, that it seeks nominations of scientific and technical experts to be considered as ad hoc reviewers in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) review of EPA’s white paper on genetically engineered (GE) female mosquitoes for mosquito control. 90 Fed. Reg. 34864. EPA states that it will solicit review and input from the FIFRA SAP on methodologies for determining...
July 7, 2025

APHIS Amends Regulations to Conform to Vacatur of SECURE Rule

On June 16, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a final rule making technical amendments to the Code of Federal Regulations (C.F.R.) to conform the C.F.R. to the U.S. District Court for the Northern District of California’s vacatur of USDA’s May 2020 final rule for organisms developed using genetic engineering. 90 Fed. Reg. 25123. The rule was effective June 16, 2025. As reported in our May 18, 2020, memorandum, the...
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...
January 2, 2025

APHIS Restarts Permitting and “Am I Regulated” Processes for Products of Biotechnology

As reported in our December 5, 2024, blog item, 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,...
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,...
November 7, 2017

USDA Withdraws Proposed Rule on the Importation, Interstate Movement, and Environmental Release of C

By Lynn L. Bergeson and Margaret R. Graham On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register (82 Fed. Reg. 51582) stating that it was withdrawing its January 19, 2017, proposed rule on the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms to “update the regulations in response to advances in genetic engineering and...
May 18, 2017

USDA Schedules Public Meetings on Proposed GE Organism Regulations

By Lynn L. Bergeson and Margaret R. Graham On May 18, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published a notice in the Federal Register announcing the dates it would be hosting three public meetings to provide the public with an opportunity to offer comments on the proposed revisions to its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE)...
February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Or

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies...
October 2, 2015

EPA Holds Workshop For Input On Risk Assessment Of Genetically Engineered Algae

On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs...