News & Analysis as of

U.S. Department of Agriculture Biotechnology

Bergeson & Campbell, P.C.

NIFA Announces $5.3 Million Investment in Biotechnology Risk Assessment Research

The Biotechnology Risk Assessment Grants (BRAG) program supports the development of new information that will assist federal regulatory agencies in making evidence-based decisions about the effects of genetically engineered...more

Bergeson & Campbell, P.C.

APHIS Announces New Flexibility for BRS Importation Permits in APHIS eFile

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...more

MoFo Life Sciences

Microbes, Biotech Investigations, And Impacts: Midsummer Regulatory Updates From USDA-APHIS

MoFo Life Sciences on

After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its...more

Bergeson & Campbell, P.C.

Biotechnology Regulatory Services Will Hold Annual Stakeholder Meeting on November 14, 2024; Stakeholders Can Suggest Topics until...

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 will on November 14, 2024. The meeting will take...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Perkins Coie

USDA APHIS Invites Stakeholder Comments on Regulation of Modified Microbes

Perkins Coie on

In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more

ArentFox Schiff

USDA’s Biotechnology Regulator Issues Much-Anticipated RFI on Regulation of Modified Microbes

ArentFox Schiff on

On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically...more

Bergeson & Campbell, P.C.

USDA’s Spring 2024 Unified Agenda Includes Rulemakings Concerning Biobased Products and Biotechnology

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...more

Bergeson & Campbell, P.C.

Biden-Harris Administration Announces Actions to Accelerate U.S. Domestic Biomanufacturing Capacity

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...more

Bergeson & Campbell, P.C.

National Security Commission on Emerging Biotechnology Announces Introduction of Agricultural Bills

On May 23, 2024, the National Security Commission on Emerging Biotechnology (NSCEB) issued a press release applauding its Congressional Commissioners — Senators Alex Padilla (D-CA) and Todd Young (R-IN) and Representatives...more

Bergeson & Campbell, P.C.

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and...more

Beveridge & Diamond PC

EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks

Beveridge & Diamond PC on

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in...more

Bergeson & Campbell, P.C.

CRS Publishes Report on Regulation of Gene-Edited Plants and Issues for Congress

The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation...more

MoFo Life Sciences

UPOV Updates Explanatory Note On Essentially Derived Varieties (EDVS)

MoFo Life Sciences on

In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular...more

Morrison & Foerster LLP

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more

MoFo Life Sciences

New Regulations Rooted In Evidence: Looking Back On How EPA And USDA Updated Engineered Plant Regulations And Labeling In 2023

MoFo Life Sciences on

Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year....more

Morrison & Foerster LLP

Comment on Morphing U.S. Biotechnology Regulations

Morrison & Foerster LLP on

The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more

ArentFox Schiff

Biden Administration Proposes Significant Changes to Regulations Implementing the National Environmental Policy Act

ArentFox Schiff on

The energy transition and increased public focus on environmental issues have strained the existing regulatory regime including the National Environmental Policy Act (NEPA). NEPA directs agencies to conduct environmental...more

Bergeson & Campbell, P.C.

Bipartisan Legislation Would Strengthen USDA’s BioPreferred Program

On July 24, 2023, Senators Amy Klobuchar (D-MN), Joni Ernst (R-IA), Debbie Stabenow (D-MI), and Pete Ricketts (R-NE) introduced the Biomanufacturing and Jobs Act to strengthen the U.S. Department of Agriculture’s (USDA)...more

MoFo Life Sciences

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

MoFo Life Sciences on

After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

MoFo Life Sciences

The Legal And Regulatory Landscape Evolving With AI In Life Sciences

MoFo Life Sciences on

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

TransPerfect Legal

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

TransPerfect Legal on

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

Bergeson & Campbell, P.C.

ASTM International Publishes Case Study on Standards for Biodegradable Plastic

To celebrate its 125th anniversary, ASTM International invited case study submissions from committee members to highlight standards that have made a significant impact in society. One of the winning entries is on a set of...more

Bergeson & Campbell, P.C.

USDA Celebrates Inaugural National Biobased Products Day, Announces 2022 Award Winners for BioPreferred® Program “Excellence in...

On March 8, 2023, the U.S. Department of Agriculture (USDA) announced the kickoff of the inaugural National Biobased Products Day and highlighted the accomplishments of people and organizations working to improve...more

ArentFox Schiff

What Can the Agriculture Sector Expect from Rep. Andy Harris on Agriculture and BioTech Appropriations

ArentFox Schiff on

The Republican leadership in the US House of Representatives has named Rep. Andy Harris (R-MD-1) chair of the Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration. As its name suggests,...more

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