How are GMOs Regulated?
U.S. Requirements and Laws Governing Genetically Modified Organisms
Aug 25, 2009
The current U.S. laws regulating genetically modified organisms (GMOs) were established in 1986 as the Coordinated Framework for Regulation of Biotechnology, and involve the cooperation of three federal regulatory agencies:
- the Food and Drug Administration, part of the Department of Health and Human Services (FDA)
- the Animal Plant Health Inspection Service, part of the Department of Agriculture (APHIS)
- the Environmental Protection Agency (EPA).
Some biotechnology products are reviewed by all three agencies, some by only one or two. Consultation with the FDA is voluntary, and not strictly regulatory. In this sense, the U.S. government treats GMOs mostly as pesticides, not as food products per se.
EPA Regulation
The Food and Drug Administration regulates the creation, sale, use, and testing of pesticides. The EPA therefore has authority over any GMO which has been engineered to include a pesticide as part of its genetic makeup. This is a common strategy for genetically modified food staple crops such as corn, potatoes, and soy. The bacterium, Bacillus thuringiensis (Bt), an organism which lives in the soil, has a gene which, when isolated, can be incorporated into a plant's genetic makeup and function as a pesticide.
Plants which contain this gene, then, are regulated just as other pesticides. The EPA regulates their testing, as well as determining safe and acceptable levels of the pesticide. Manufacturers of these organisms must also address concerns about the short- and long-term effects of the pesticides on humans, livestock who consume feed crops, and the environment. The EPA regulates only the genetic material incorporated into the plant, and not the plant itself.
USDA Regulation
Part of the USDA's role is to ensure the health and safety of plants. APHIS, therefore, regulates some genetically modified organisms which may pose a risk to plant health. The USDA accomplishes this partly by asking those designing, creating, and using GMOs to apply for a permit. The applicant must address not only the possibly risks to plant and animal health, but also any possible spread of the organism into the environment. Producers must apply for a permit before any new introduction of a GMO; this may include the release of a new organism, as well as importation or interstate movement of extant organisms.
Developers must provide evidence that a GMO provides no more risk that the equivalent non-genetically modified organism.
FDA Regulation
Since 1992, the FDA recommends that developers of genetically modified food products consult with the FDA to discuss nutrition and food safety issues. Though developers routinely consult with the FDA, such consultation is voluntary, not required. Consultation focuses on questions of nutrition, possible toxicity, and possible allergens, but relies on information provided by the product developer.
GMOs are used most frequently as raw ingredients in processed foods and as feed for livestock which become food, such as grain-fed cattle. Consumers who eat the end products of these industrial food systems -- prepared foods, some restaurant foods, and many meat products -- therefore consume GMOs, though the food products are not typically labeled. Consumers who are concerned, and wish to limit or eliminate their consumption of GMOs, should maximize their consumption of organic produce, locally produced foods, foods labeled and marketed as non-GMO, free-range meats, and foods which they prepare themselves (as opposed to processed foods). Even these steps do not guarantee that a consumer's diet will not contain GMOs, and will not unless labeling becomes a requirement.
Further Reading
EPA guidelines on plant-incorporated pesticides
Michael Pollan, The Botany of Desire (Random House, 2001)
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