All Knowledge & Insights By Date

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 that will replace the BRS Permitting Assistant in APHIS eFile. According to APHIS, applicants using APHIS eFile will experience: An interface that leads applicants through a series of questions to determine if their application qualifies for a notification or if a permit...

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 Submitting Data for Reports and Notices in APHIS eFile and the Response to Comments: Guide to Submitting Data for Reports and Notices in APHIS eFile. In October 2023, to clarify and streamline its biotechnology regulations further, BRS published for comment a draft guide to...

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 agenda includes the following items: Program Highlights: An overview of BRS’ fiscal year (FY) 2024 successes; Regulatory Status Review...

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...

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...