FDA’s Regulation of Plant and Animal Biotechnology Products

Better understand genetically engineered foods (commonly called GMOs)

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

• Interagency Documents on the Unified Website for Biotechnology Regulation

  In an effort to further regulation that supports safe innovation, FDA, EPA and USDA posted two documents on the Unified Website for Biotechnology Regulation. Each agency provided updates on the availability of the documents to their respective stakeholders.

  • Report on stakeholder comments on areas of uncertainty in the Coordinated Framework for the Regulation of Biotechnology.
  • Plain-language information on agency roles, responsibilities, and processes for the regulation of products of biotechnology.
• 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)