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 entering information into permit applications, and provides sample supplemental permit conditions for the two most frequently permitted crop types (corn and soybean) and import and interstate movement permits; and
• Updated Guide for Submitting Permit Applications for Microorganisms — Includes instructions for completing a streamlined permit application for interstate movement of multiple microorganisms between contained facilities.

According to APHIS, these resources deliver some of the commitments identified in the May 2024 Plan for Regulatory Reform that USDA, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) developed to support Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” APHIS BRS continues its work on other deliverables to clarify and streamline further its biotechnology regulations. More information on the May 2024 Plan for Regulatory Reform is available in our May 16, 2024, memorandum.