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APHIS Reinstates Legacy Biotechnology Regulations: Implications for CRISPR-Edited Plants

USDA Animal and Plant Health Inspection Service (APHIS) announced on January 23, 2025, that it is reinstating its legacy notification procedure as of February 7, 2025, providing a streamlined alternative to permits for...more

Bergeson & Campbell, P.C.

United States Prevails in USMCA Dispute on Genetically Engineered Corn

The U.S. Department of Agriculture (USDA) announced on December 20, 2024, that the United States prevailed in its dispute under the United States-Mexico-Canada Agreement (USMCA) challenging certain Mexican biotechnology...more

Bergeson & Campbell, P.C.

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...more

Bergeson & Campbell, P.C.

USDA Issues Streamlined Regulation for Biobased Markets (BioPreferred) Program

The Rural Business-Cooperative Service (RBCS), an agency of the Rural Development mission area within the U.S. Department of Agriculture (USDA), issued a final rule on December 9, 2024, that adopts changes from the...more

Bergeson & Campbell, P.C.

Registration Opens for USDA’s 101st Agricultural Outlook Forum

The U.S. Department of Agriculture (USDA) has opened registration for the 101st Agricultural Outlook Forum. The event, entitled “Meeting Tomorrow’s Challenges, Today,” will be held at the Crystal City Gateway Marriott in...more

Bergeson & Campbell, P.C.

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...more

Bergeson & Campbell, P.C.

BRS Will Hold Annual Stakeholder Meeting on November 14, 2024

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...more

Bergeson & Campbell, P.C.

APHIS Announces Updated Permitting Resources for Developers

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...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

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

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.

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

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

Morrison & Foerster LLP

Comment on Morphing U.S. Biotechnology Regulations

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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

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

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

Bergeson & Campbell, P.C.

APHIS Announces Final Regulatory Status Review Guide

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information...more

Wiley Rein LLP

[Podcast] Keith Matthews and Chris Wozniak: Talking Ag Biotech Episode 2

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In this second episode of the Talking Ag Biotech podcast on regulatory policies and procedures impacting agricultural biotechnology, Keith Matthews and Chris Wozniak discuss President Biden’s recent Executive Order on...more

Bergeson & Campbell, P.C.

APHIS Issues RSR Responses under Revised Biotechnology Regulations

On September 7, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it reviewed a new tomato from Norfolk Plant Sciences. The tomato was modified to alter its...more

Bergeson & Campbell, P.C.

APHIS BRS Will Hold Annual Stakeholder Meeting on December 8, 2022

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 December 8, 2022. BRS will offer in-person, at...more

Wiley Rein LLP

President Biden Signs Executive Order 14081 to Promote Biotechnology and Biomanufacturing

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In the latest of a series of Presidential actions intended to promote biotechnology and confirm the continued support of advances in biotechnology as official policy of the United States, on September 12, 2022, President Joe...more

Bergeson & Campbell, P.C.

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised...more

Beveridge & Diamond PC

USDA Announces Intent to Transfer Regulatory Authority Over Animal Biotechnology from FDA to USDA

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Key Takeaways What Happened: USDA is seeking comment on its intent to transfer portions of the regulatory framework governing agricultural animals modified or produced by genetic engineering from USDA to FDA....more

Beveridge & Diamond PC

SECURE Rule Amends USDA Regulation of Genetically Engineered Organisms

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The Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA) has published final amendments to its biotechnology regulations codified at 7 C.F.R. part 340 under the Plant Protection...more

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