On This Page:

U.S. Department of Agriculture
U.S. Food and Drug Administration
U.S. Environmental Protection Agency

In the United States, three different agencies have regulatory jurisdiction over genetically engineered organisms: the US Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). In 1986, the US government developed its "Coordinated Framework for Regulation of Biotechnology," which outlines how the regulatory responsibilities are divided among the three agencies, based largely on the existing regulatory framework. The jurisdictions of each are described briefly below. Follow the links below to a more detailed discussion of each agency.

New U.S. Government website on GE regulation
The U.S. Government recently unveiled a new website that combines in one easy-to-use location regulatory information about genetically engineered crops in the U.S. The website organizes information previously available from the Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency. The website also includes a searchable database of government safety-related decision documents and environmental impact statements for all genetically engineered crop varieties considered by the relevant agencies. Visit this website here.

The US Department of Agriculture has two responsibilities in the regulation of GE crops, both of which are administered through its Animal and Plant Health Inspection Service (APHIS). Because the responsibility of APHIS has traditionally been to monitor and control the spread of introduced exotic plants, animals, and their diseases, newly introduced genetically engineered organisms are regulated similarly. First, APHIS monitors plantings of experimental varieties of GE plants in field trials. Secondly, before a new GE crop variety is marketed, APHIS evaluates the potential impact of widespread environmental release of the plant-- the potential weediness of the new GE crop, unintended transfer of genes to weeds and other crop species, impacts on beneficial insects, etc. APHIS is usually the first agency to consider the safety of a new GE crop.
[top of page]

If a new GE crop variety will be consumed by humans or animals, the US Food and Drug Administration is responsible for evaluation of its food safety. In practice, the regulatory paradigm used by the FDA is "substantial equivalence"-- that is, the allergen, nutrient and toxin content of the new GE food must fall within the normal range of the equivalent, conventional food. If so, the FDA does not regulate the GE food any differently than others. If however, the FDA determines that a GE food is not equivalent to a conventional product (if, for example, it is more likely to cause allergies), then the GE food must be either labeled or, if health concerns are serious enough, not allowed to be marketed at all.
[top of page]

Because some GE plants manufacture their own pesticides (Bt corn, for example) the US Environmental Protection Agency is responsible for the safety of the pesticide levels in those GE plants which produce them. This jurisdiction extends to both human health and environmental impacts of the pesticide. For this reason, the EPA (and not the FDA) is responsible for the safety of the CRY9C protein in StarLink corn. The EPA also has an indirect regulatory role: if a crop plant has been engineered to be resistant to an herbicide, the EPA must approve the use of that herbicide on the crop.
[top of page]