All Knowledge & Insights By Date

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) Biotechnology Regulatory Services (BRS) announced on September 12, 2024, the availability of the following updated resources to help developers more efficiently prepare and submit APHIS BRS permit applications: Permit User Guide -- Implements stakeholder feedback to clarify information requirements and how BRS uses the information when reviewing permit applications, provides tips on efficiently...

TSCA/FIFRA/TRI EPA Updates Safer Choice And DfE Standard: The U.S. Environmental Protection Agency (EPA) announced on August 8, 2024, the availability of the final updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination...

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...

On August 2, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced a new flexibility for BRS importation permits in APHIS eFile. APHIS states that it has implemented a new flexibility allowing permit holders to reuse import labels. According to APHIS, permit holders no longer need to request additional labels if they have used all the import labels received with their permit. APHIS notes that...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual stakeholder meeting on November 14, 2024. The meeting will take place in person at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland, with an option for virtual attendance. The meeting will include updates on: Highlights from fiscal year 2024; Priorities for fiscal year 2025; and Business process improvements. BRS requests...

On July 5, 2024, the U.S. Department of Agriculture (USDA) released its spring 2024 Unified Agenda, which includes the following items regarding biobased products and biotechnology: Higher Blends Infrastructure Incentive Program: The Higher Blends Infrastructure Program is designed to increase the sales and use of higher blends of ethanol and biodiesel by expanding the infrastructure for renewable fuels derived from U.S. agricultural products. The Rural Business-Cooperative Service (RBCS)...

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...

The White House Office of Science and Technology Policy (OSTP) published a fact sheet on June 25, 2024, on the Biden-⁠Harris Administration’s actions to advance American biotechnology and biomanufacturing. According to the fact sheet, on June 25, 2024, the White House, members of the National Bioeconomy Board, and the U.S. Departments of Energy (DOE), Defense (DOD), and Agriculture (USDA) convened major biotechnology and biomanufacturing companies, nonprofits, and other stakeholders to...

TSCA/FIFRA/TRI                                                                                                                           EPA Announces New Resource Portal And Reporting Tool Improvements Before CDR Reporting Begins On June 1, 2024: On May 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the creation of CDR GuideME, a new resource portal, and...