News & Analysis as of

APHIS Biotechnology Agricultural Sector

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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.

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.

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.

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.

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

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

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

Bergeson & Campbell, P.C.

Final SECURE Rule Will Update and Modernize USDA’s Biotechnology Regulations

On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE)...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Bergeson & Campbell, P.C.

APHIS Announces Launch Of eFile This June

On May 8, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced the pilot launch of its new online permitting system: APHIS...more

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