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FDA Regulations of Genetically Engineered Foods

The US Food and Drug Administration, or FDA, is one of three governing bodies that regulate genetically engineered foods, also known as genetically modified (GM) foods. The current regulations are largely the result of a 1986 agreement called the "Coordinated Framework for Regulation of Biotechnology." For the most part, the FDA treats foods that have been genetically modified as ordinary foods.

  1. Scope of FDA

    • The FDA exercises the broadest control over GM foods. Food and food additives are the relevant categories that the FDA oversees. In a 1992 decision, the FDA stated that GM foods are to be treated as ordinary foods and not considered as food additives; they are "generally regarded as safe" or GRAS. Unless the GM food looks remarkably different from its whole counterpart, the FDA requires no testing or safety measures before the food is sent to the consumer or to be further processed. This can be contrasted with the treatment of food additives, which are safety-checked. In 2009, the FDA stated that this policy extends to animals that have been genetically modified as well.

    Voluntary Process

    • The 1992 policy also created a process in which the manufacturer may voluntarily bring a GM food to the FDA for consultation regarding safety and regulatory issues. Again, this process is separate from the food additive process, wherein safety testing is mandatory and not voluntary. The voluntary policy for GM food is intended to help resolve safety issues without such a process. Ultimate responsibility regarding the safety of food products rests in the hands of the manufacturer.

    Outside Scope of FDA

    • To understand the FDA’s regulations on GM foods, it is important to know what the FDA does not cover. The Environmental Protection Agency, or EPA, monitors and checks the safety of all pesticide use and sets the levels at which they may be present in foods. This applies to GM plants, which create their own pesticide. The United States Department of Agriculture, or USDA, monitors field testing of crops to ensure the safety of new GM plant strains via its Animal and Plant Health Inspection Service. Thus, the FDA does not oversee the processes that create the GM foods, such as field tests of new strains or GM food that contains its own pesticide. Instead, the FDA is concerned only with the end product, such as the GM corn kernel or soybean.

    Labels

    • Labeling falls under the scope of FDA oversight. Manufacturers are not required to note on product labels whether or not a product contains GM food. Only if the GM food differs enough so that the usual name does not apply, differs in nutritional content, differs in use or includes a new allergen are manufacturers required to label the food as such. The FDA will review foods and their labels on a voluntary basis should the manufacturer wish.

    Concerns

    • Critics have expressed concern that the regulation of GM foods is inadequate and that coordination among the FDA, USDA and EPA is lacking. Some suggest that a single agency, such as the FDA, ought to handle the regulation of GM foods. Additionally, the FDA ought to reconsider its assumption that GM foods are GRAS and take into account how the foods are created instead of the final product. Labeling is also an issue—many have challenged the FDA’s labeling policy, claiming that products containing GM food should be labeled as such.

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