News & Analysis as of

Biotechnology U.S. Department of Agriculture

Bergeson & Campbell, P.C.

APHIS Announces Updated Pre-Application Questionnaire in APHIS eFile

On June 13, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that its Biotechnology Regulatory Services (BRS) has launched an updated Pre-Application Questionnaire...more

Beveridge & Diamond PC

Mexico Bans the Cultivation of Genetically Modified Corn, Opening Door for Other Restrictions in the Future

According to a March 21, 2025 report issued by the U.S. Department of Agriculture (USDA)’s Foreign Agricultural Service, the scope of Mexico’s recent ban on the cultivation of genetically engineered (GE) corn is “ambiguous”...more

Bergeson & Campbell, P.C.

APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going...

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...more

Bergeson & Campbell, P.C.

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...more

Morrison & Foerster LLP - Class Dismissed

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.

CRS Updates Report on Gene-Edited Plants: Regulation and Issues for Congress

The Congressional Research Service (CRS) posted a November 30, 2024, update to its report entitled “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated...more

Knobbe Martens

New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape

Knobbe Martens on

On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for...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.

EPA, FDA, and USDA Release Tool to Help Companies Developing Microbial Biotechnology Products Navigate Regulatory Landscape

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...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.

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

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