APHIS eFile: New SOP Template for Modified Microbe Movement Permits
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) is announcing additional flexibilities and assistance for modified microbe movement permits in APHIS eFile.
In response to stakeholder feedback and our desire to improve the efficiency and predictability of our permitting process, we are taking steps to reduce processing times and strengthen consistency when reviewing and issuing permits for microbes developed using genetic engineering. As part of this effort, BRS has standardized supplemental permit conditions for import and interstate movement permits for modified microbes and posted a voluntary Standard Operating Procedure (SOP) template (261.35 KB) to assist applicants with completing applications for modified microbes movement permits under 7 CFR part 340. Applicants may elect to use this optional format when preparing SOPs to accompany permit applications. The template outlines topics and suggested information to include in SOPs that describe how applicants will maintain modified microbes to prevent their unauthorized release, spread and/or persistence in the environment.