USDA APHIS releases preview of request for information on options for reducing regulations for modified microbes

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.″ 

Executive Order 14081 promotes advancing biotechnology and biomanufacturing for innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.  It supports the just and equitable investment of resources to benefit all Americans, especially those in underserved communities, as well as the broader global community. 

The notice inviting public comment will be published in the Federal Register in the coming days.  After publication, the public can submit comments for 60 days through either of the following methods:

• Federal eRulemaking Portal: Go to Regulations.gov. http://www.regulations.gov/#!docketDetail;D=APHIS-2024-0002 (available after publication)

• Postal Mail: Send your comment to Docket No. APHIS-2024-0002, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. 

View RFI Preview 

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