The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has released a Request for Information (RFI) to solicit public comment on potential options to streamline and reduce regulatory burden for modified microbes. The RFI aims to obtain feedback on pathways to commercialization and potential changes to the regulatory framework for assessing the plant pest risk of modified microorganisms. APHIS is seeking input on the following:
* New or emerging categories of biotechnology products relevant to modified microorganisms
* Expertise and resources needed to evaluate plant pest risk
* Clarity and efficiency of regulations governing modified microorganisms
* Key elements of a regulatory framework for assessing plant pest risk
* Biological features of microorganisms to consider when determining plant pest risk
* Criteria for assessing plant pest risk
* Criteria for regulating microorganisms with multiple uses
* Potential for risk-based exemptions for certain types of microorganisms
* Examples of modified microorganisms that should be exempt from regulation and evidence to support these exemptions
The RFI is open for public comment until September 3, 2024. The purpose of the RFI is to identify potential criteria and mechanisms for risk-based deregulation, develop a regulatory framework, and identify non-regulatory solutions to improve coordination with the EPA and APHIS’s Plant Protection and Quarantine. This RFI provides an opportunity for developers and stakeholders to shape a clearer and more streamlined regulatory pathway for modified microbes, promoting innovation in agricultural industries.