On October 13, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of a revised draft of the Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 and a Response to Comments on the first draft of the Guide, published on March 23, 2023.

APHIS’s Biotechnology Regulatory Services (BRS) received comments on a range of issues and grouped the comments and its responses into the following categories:

• Permit application data requirements;

• Principle risk proportionality when determining data requirements;

• Permit requirements when conducting research in a contained facility;

• Coordination among regulatory agencies; and

• Clarification on modified microbes that are excluded or exempted from 7 C.F.R. Part 340.

BRS notes that beyond these categories, it also received comments related to how it verifies the information in permit applications, enhancing the Standard Operating Procedures (SOP) that accompany permit applications, and requests for establishing a Regulatory Status Review (RSR) along with regulatory exemptions for modified microbes to support their commercialization. BRS states that “[c]omments about labelling and general comments about ecosystem service provided by microbes are out of scope for the guide, and BRS will not address them here.”

Background

As reported in our March 23, 2023, blog item, the draft Guide is intended to assist developers with preparing a permit application for movement activities with modified microorganisms under 7 C.F.R. Part 340 (Movement of Organisms Modified or Produced through Genetic Engineering). The draft guide states that genetic engineering is defined in 7 C.F.R. Section 340.3 as “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.” According to the draft guide, regulated microorganisms include plant pests and other modified microorganisms that could pose a plant pest risk. Developers require a permit for regulated activities involving any modified microorganism that:

• Meets the definition of a plant pest in Section 340.3; or

• Is not a plant but has received deoxyribonucleic acid (DNA) from a plant pest, as defined in Section 340.3, and the DNA from the donor organism is either capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or

• Is a microorganism used to control plant pests and could pose a plant pest risk.