The U.S. government has a stringent, well-coordinated regulatory process for determining the safety of agricultural products of modern biotechnology.

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Other government sites:   - USDA   - FDA

The U.S. regulatory process ensures that all biotech products that are commercially grown, processed, sold, and consumed are as safe for the environment and for human and animal health as their conventional counterparts. Biotechnology in the United States is rigorously regulated under a risk-based system and was initially established in 1986 under the Coordinated Framework. The U.S. Government's regulatory system is transparent, predictable, open to public comment, and based on sound science. It is continuously reviewed and evaluated to ensure that it meets the challenges to this evolving technology. The agencies responsible for its regulation are the USDA's [U.S. Department of Agriculture] Animal and Plant Health Inspection Service, the Environmental Protection Agency, and the Food and Drug Administration.

USDA's Animal and Plant Health Inspection Service (APHIS) is responsible for protecting American agriculture against pests and diseases and ensures that biotech products are safe for agricultural use. APHIS is the U.S. Government's lead agency regulating the safe field-testing of biotechnology-derived, new plant varieties and certain microorganisms. APHIS also approves and licenses veterinary biological substances, including animal vaccines, that may be the product of biotechnology.

The Environmental Protection Agency (EPA) approves new herbicidal and pesticidal substances. EPA also issues permits for large scale testing of herbicides and biotechnology-derived plants containing new pesticidal substances. In deciding whether to register a new pesticide, EPA considers human safety, the fate of the substance in the environment, the safety for humans, its effectiveness on the target pest, and any effects on other, so-called "non-target" species. EPA ensures that genetically engineered products classified as pesticides are used safely in the environment.

FDA ensures that foods derived from new bio-engineered plant varieties are safe and wholesome, holding them to the same high standard of safety as any food product. FDA is also responsible for enforcing regulations to ensure that all food and feed labels, including those related to biotechnology, are truthful and non-misleading.

Every biotech plant variety commercially grown in the United States has gone through the necessary regulatory process at APHIS, EPA, and FDA.