/>i- On October 13, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) released a revised draft of the Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering Under 7 CFR Part 340 and Response to Comments from the first draft that was published March 23, 2023.
- The draft has been revised based on the public comments APHIS received from the first draft. APHIS grouped the various comments and responses into the following categories: 1) permit application data requirements; 2) principle risk proportionality when determining data requirements; 3) permit requirements when conducting research in a contained facility; 4) coordination among regulatory agencies; and 5) clarification on modified microbes to support their commercialization.
- The purpose of requiring permits for genetically engineered microorganisms under 7 CFR 340 is to protect and enhance US agricultural and natural resources using a science-based and risk-based regulatory framework to ensure the safe movement of these microorganisms. Regulated microorganisms include plant pests and other microorganisms that could pose a plant pest risk.
- Keller and Heckman will continue to follow and report on these important regulatory developments.
APHIS Releases Revised Guidance for Genetically Engineered Microorganism Applications
Thursday, October 19, 2023
