FDA’s Regulation of Plant and Animal Biotechnology Products
What's New
On November 13, 2023, and in response to President Biden’s Executive Order 14081, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA) posted two documents on the Unified Website for Biotechnology Regulation. The agencies issued a report on stakeholder comments on the Coordinated Framework for the Regulation of Biotechnology. The agencies also posted plain-language information on agency roles, responsibilities, and processes for the regulation of products of biotechnology. Each agency provided updates on the availability of the reports to their respective stakeholders.
On December 19, 2022, the White House Office of Science and Technology Policy (OSTP) — in coordination with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products.
The FDA regulates plant and animal biotechnology products in coordination with the U.S. Department of Agriculture (USDA) and U.S. Environmental Protection Agency (EPA), consistent with the U.S. Coordinated Framework for the Regulation of Biotechnology. Each of these regulatory agencies has developed regulations and guidance documents to implement its authority under existing laws to help ensure the safety and, where applicable, the effectiveness of biotechnology products.
As the landscape of biotechnology products evolves along with advances in molecular techniques, the FDA is committed to protecting public and animal health and to working with stakeholders to increase the transparency, coordination, and predictability of the regulatory system to enhance public confidence in the regulatory system while also avoiding unnecessary barriers to innovation.
Plant and Animal Biotechnology Programs and Activities at the FDA
- Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy (Executive Order Number 14081)
The Executive Order signed September 12, 2022, launched a National Biotechnology and Biomanufacturing Initiative (NBBI). This initiative will help drive research and development, improve access to quality federal data, grow domestic manufacturing capacity, expand market opportunities for biobased products, train a diverse and skilled workforce, streamline regulatory processes for products of biotechnology, advance biosafety and biosecurity to reduce risk, protect the U.S. biotechnology ecosystem, and build a thriving and secure global bioeconomy with partners and allies. - Feed Your Mind--Agricultural Biotechnology Education and Outreach Initiative
The FDA continues to work with EPA and USDA to modernize the regulatory system for plant and animal biotechnology products. - Food from New Plant Varieties
Information about the FDA’s role in overseeing the safety of human and animal foods derived from genetically engineered plants. - Biotechnology Products at the Center for Veterinary Medicine: Animals and Animal Food
Information about animal-related biotechnology products. - Intentional Genomic Alterations in Animals
Guidance documents, approvals, and other information related to animals with intentional genomic alterations.
Resources for You
- Human & Animal Food Biotechnology Guidance Documents & Regulatory Information
- Center for Veterinary Medicine Biotechnology Guidances
- Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology
- Coordinated Framework for the Regulation of Biotechnology (1986)
- Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System | National Academies (2017)
- Genetically Engineered Crops: Experiences and Prospects |National Academies (2016)