The U.S. Department of Agriculture’s (USDA) Animal and Health Inspection Service (APHIS) announced on June 25, 2024, that it will soon publish a request for information (RFI) in the Federal Register, beginning a 60-day public comment period. According to APHIS, the RFI will explore options to reduce the regulatory burden for modified microbes. APHIS states that it developed the RFI in response to stakeholder requests. Specifically, APHIS will request comments to help identify:

• Potential criteria and mechanisms for risk-based deregulation of engineered microbes;
• Prospective regulatory and non-regulatory pathways to commercialization;
• A possible regulatory framework that could inform future rulemaking; and
• Viable non-regulatory solutions for APHIS Biotechnology Regulatory Services to improve coordination with APHIS Plant Protection and Quarantine and the U.S. Environmental Protection Agency (EPA).

According to APHIS, this information will help improve the clarity and efficiency of the regulatory processes for biotechnology products as described in Executive Order (EO) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” More information on EO 14081 is available in our September 13, 2022, blog item. APHIS states that the RFI will be published in the Federal Register “in the coming days.” APHIS posted a pre-publication version of the RFI.