(AGENPARL) – mer 08 maggio 2024 Issued: May 8, 2024 (2:04pm EDT)
If you wish to unsubscribe please do so
here: http://url6130.epa.mediaroom.com/ls/click?upn=u001.iqz6hAvLdUl-2FaSixKUG3iyFJBsxNAroAZOQ1BID8fKIiLAUfJX2sQlhu1tzKAOIu-2BU84uzAzSpWvmWyHnsNJDRYXWx5dlMz75Zp9ch-2BQlG6mQHPYjReZhS13hvd5qOopXk3g_-2B0Ok6Af7hyz7Kqg6CR74pYblAA1WjrUjKSJUAiv3NOub0DC4O7JPWGxIlQ7kBB-2FSqugTGFBApl1yqRXe3-2BeWYV0b99OIeIoobup6I8OgUPkclf3ikvgNrKp-2Fh-2Bp-2BVyHkA4zubupZqjtvYCwd6dnTbqphXMgBfc-2FvZAKVlKGEaFRPEoE9YG0TZiGnyBraI0dAFsCmnR8-2FNj1ulPkHnWRnuhMyOcyke-2FcJq7-2Fb-2Bee1LDgpWTOiIklasyGELs3J-2FB657l57SdF1lZ2iSS-2B2ER-2Ba1g-3D-3D
EPA, FDA and USDA Issue Updates to the Joint Regulatory Plan for Biotechnology
WASHINGTON – Today, May 8, 2024, in response to President Biden’s
Executive Order 14081, “Advancing Biotechnology and Biomanufacturing
Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the
U.S. Environmental Protection Agency, the U.S. Food and Drug Administration
and the U.S. Department of Agriculture have developed a plan to update,
streamline and clarify their regulations and oversight mechanisms for products
of biotechnology.
The plan helps meet the President’s goals of ensuring public confidence in
the biotechnology regulatory system and improving its transparency,
predictability, coordination and efficiency. Through engagement with
developers and stakeholders, as well as horizon scanning for novel
biotechnology products, the agencies worked collaboratively to develop a
cohesive plan. The plan incorporates 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 plan supports a whole-of-government approach to the
regulation of biotechnology products.
The agencies have identified five major areas of biotechnology product
regulation where these actions will focus:
Modified plants
Modified animals
Modified microorganisms
Human drugs, biologics and medical devices
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.
The federal government established the Coordinated Framework for the
Regulation of Biotechnology in 1986 and most recently updated it in 2017. It
describes the comprehensive federal regulatory policy for ensuring the safety
of biotechnology products, including how EPA, the FDA and USDA share
responsibility for regulating many of the products of biotechnology in the
United States. The Executive Order directs the three agencies to improve how
they implement the Coordinated Framework.   
In response to the Executive Order, the three regulatory agencies, in
consultation with the Office of Science and Technology Policy, issued a
Request for Information to the public to solicit information on regulatory
ambiguities, gaps, uncertainties or inefficiencies in the Coordinated
Framework. The agencies received 88 distinct public comments, including a
sign-on letter from over 6,000 members from biotechnology developers,
producers, manufacturers, non-governmental organizations and academia. The
agencies will continue to engage with all interested stakeholders as they
implement the plan.
Visit the Unified Website for Biotechnology Regulation for additional
information on modernizing the regulatory system for biotechnology products
and Executive Order 14081.
To unsubscribe or change your settings click here:
http://url6130.epa.mediaroom.com/ls/click?upn=u001.iqz6hAvLdUl-2FaSixKUG3iyFJBsxNAroAZOQ1BID8fKKhIILjisBDEktm3-2BIos9X6MD8NHPlwx2k-2B6pnkz87X20sW91J1FGjQV6HW16QlzmaDBMIOHg7kpO5KY9cdfb0Kp-2Bd5dRPJTyse0fqPta-2F7zQ-3D-3DtM7I_-2B0Ok6Af7hyz7Kqg6CR74pYblAA1WjrUjKSJUAiv3NOub0DC4O7JPWGxIlQ7kBB-2FSqugTGFBApl1yqRXe3-2BeWYV0b99OIeIoobup6I8OgUPkxoj7ybGoOCWk2DCcDez9lKI14WLJcteQ8u75FSHUNoTWLaIYHQmFvBPbimyqHbzth9yt6Pl7KG50bprkT8pTAhlPDHVH9LL800ouLNxc2jJ-2FXo2wvw0-2BkgIasyVzNYupLOjZDZEm8j05XGddODp-2FdiYTpSTxQ4nYC0u50zOY8YA-3D-3D