Exploring Pathways to Commercialization for Modified Microbes

Issuing agencies

Abstract

We are notifying the public that the Animal and Plant Health Inspection Service (APHIS) is soliciting the public to respond to this Request for Information (RFI) as part of our stakeholder engagement to explore pathways to commercialization for modified microbes subject to APHIS jurisdiction, consistent with the APHIS regulations for the movement of organisms modified or produced through genetic engineering. In response to the Office of Science and Technology Policy's (OSTP's) RFI "Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology" issued in December 2022 pursuant to Executive Order 14081, multiple commenters expressed a need for clear regulatory pathways to commercialization for modified microbes. Therefore, we are requesting comments from the public regarding pathways to commercialization, including needs, ideas, and concerns, regarding possible APHIS risk- based deregulation of modified microbes and other potential regulatory and non-regulatory pathways to commercialization. The information provided will help to identify potential criteria and mechanisms for risk-based deregulation, develop a regulatory framework that could inform future rulemaking, and identify potential non-regulatory solutions.