SILVER
SPRING, Md., May 8, 2024
/PRNewswire/ -- 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 (EPA), the U.S. Food and Drug
Administration (FDA), and the U.S. Department of Agriculture (USDA)
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 (GE) 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 (OSTP), issued a Request for Information (RFI) 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.
# # #
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration