The U.S. Department of Agriculture’s (USDA) Animal and Health Inspection Service (APHIS) will soon invite public comment for 60 days on a Request for Information (RFI) once published in the Federal Register. The RFI will explore options to reduce the regulatory burden for modified microbes.
APHIS developed this RFI in response to stakeholder requests. A copy is available for preview on the APHIS website. Specifically, the Agency 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.
This information will help improve the clarity and efficiency of the regulatory processes for biotechnology products as described in Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”
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