In response to U.S. President Joseph Biden's Executive Order 14081,
"Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,
Safe, and Secure American Bioeconomy," the U.S. Environmental Protection
Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department
of Agriculture (USDA) developed a plan to update, streamline and clarify
their regulations and oversight mechanisms for products of biotechnology.



Executive Order 14081, issued on September 12, 2022, aims to accelerate
biotechnology innovation and grow America's bioeconomy across multiple
sectors, including health, agriculture, and energy. Among other objectives,
the executive order aims to support the safe use of biotechnology products
by clarifying and streamlining regulations in service of a science and
risk-based, predictable, efficient, and transparent regulatory system.



On May 8, 2024, EPA, FDA, and USDA released the plan incorporating processes
and timelines to implement regulatory reform, such as identifying guidance
and regulations to update, streamline, or clarify, and identifying the
potential need for new guidance or regulations. The agencies identified five
major areas of biotechnology product regulation where these actions will
focus, including modified plants, modified animals, modified microorganisms,
human drugs, biologics and medical devices, and cross-cutting issues.



EPA, the FDA, and USDA intend to implement the following joint efforts:



* Clarify and streamline regulatory oversight for genetically
engineered plants, animals, and microorganisms;
* Update and expand their information sharing through an MOU to
improve and broaden communication and coordination of oversight of modified
microbes; and
* Undertake a pilot project focused on modified microbes to explore
and consider the feasibility and costs of developing a web-based tool that
informs developers about which agency may regulate a given product category.



[www.epa.gov]
atory-plan-biotechnology