/>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
Current Public Notices
Published: 19 November, 2024
Published: 16 September, 2024
Published: 21 November, 2024
Published: 18 November, 2024
Published: 4 November, 2024
Published: 29 October, 2024
