Regulatory Information

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
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