The United States Government evaluates products developed using modern biotechnology using a coordinated,
risk based system, called the Coordinated Framework for Regulation of Biotechnology. This coordinated
effort is critical in the effective regulation of biotechnology-derived crops, animal vaccines, and other products.
The agencies responsible for oversight of the products of agricultural modern biotechnology are the U.S. Department
of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA),
and the Department of Health and Human Services' Food and Drug Administration (FDA). Depending on its
characteristics, a product may be subject to review by one or more of these agencies.
United States Regulatory Agencies Unified Biotechnology Website
APHIS’ Biotechnology Regulatory Services (BRS), under the authority of the Plant Protection Act, provides
oversight of certain genetically engineered (GE) organisms to protect plant health, by regulating the
introduction—meaning the importation, interstate movement, and environmental release—of those GE organisms
that may pose a pest risk to plants. People who want to introduce these types of GE organisms must obtain
USDA’s approval and adhere to regulations to maintain adequate confinement of the organism.
Learn more about APHIS' Biotechnology Regulatory Process
EPA regulates pesticides, including crops with plant-incorporated protectants (pesticides intended to be
produced and used in a living plant) to ensure public safety from their use, including pesticide residue
on food and animal feed.
Learn more about EPA's Biotechnology Regulatory Process
FDA has primary responsibility for ensuring the safety of food and animal feed. FDA is also responsible
for ensuring the proper labeling and safety of all plant-derived foods and feeds, including those
developed through genetic engineering.
Learn more about FDA's Biotechnology Regulatory Process