Safety of Genetically Engineered Foods

by Food and Drug Administration (FDA)

(Page 2 of 4)

Genetically engineered plants are regulated by three government agencies: the FDA, the USDA, and the Environmental Protection Agency (EPA). The FDA ensures that foods made from these plants are safe for humans and animals to eat, the USDA makes sure the plants are safe to grow, and the EPA ensures that pesticides introduced into the plants are safe for human and animal consumption and for the environment. While these agencies act independently, they have a close working relationship since many products come under the review of all three.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA authority to regulate foods for humans and animals, including foods derived from bioengineered plants. Under the act, companies have a legal obligation to ensure that any food they sell meets the safety standards of the law. The safety standards apply equally to conventional food and genetically engineered food. If a food does not meet the safety standards, the FDA has the authority to take it off the market.

Bioengineered foods do not pose any risks for consumers that are different from conventional foods, says Maryanski. "We make sure there are no hazards, such as an unexpected allergen or poisonous substance in the food, or that the food is not changed in some way that would affect its nutritional value."

The FDA's efforts to ensure the safety of bioengineered foods include publishing rigorous safety testing guidelines, establishing a consultation process with industry, and seeking the expertise of scientists outside the agency.

In 1992, the FDA published a policy statement and testing guidelines for foods developed using all methods of plant breeding, including the use of genetic engineering. These guidelines explain the types of food safety questions that developers should address in evaluating the safety of all plant-derived foods.

In 1994, the FDA set up a consultation process to assist developers in meeting the safety standards set forth in its guidelines. FDA scientists advise companies on the tests needed to assess the safety of new foods. After testing is completed, companies send safety and nutritional information to the FDA for the agency's scientific evaluation.

Although consultation is voluntary on the part of developers, the legal requirements that the foods have to meet are not. Some consumer advocates and scientists have urged the FDA to make the consultation process mandatory, but the agency believes that companies are cooperating within the voluntary system.

"This current process is working very well and fully protects public health," says McClellan. "To the best of our knowledge, all bioengineered foods on the market have been evaluated by FDA through the current consultation process." This includes genetically engineered foods produced by companies outside the United States and marketed here.

In July 2003, the Codex Alimentarius Commission adopted international guidelines for biotech food safety that are consistent with the FDA's approach. Codex, an entity established by the World Health Organization and the Food and Agriculture Organization of the United Nations, is the highest international body on food standards.

Several private and government organizations have studied the safety of genetically engineered foods. In a study released in 2000, a committee of the National Academy of Sciences (NAS) concluded, "The committee is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification." This conclusion was echoed in a report published by the Government Accounting Office in 2002. On the animal side, the international Organization for Economic Cooperation and Development published a consensus document in 2003. It noted that there is no evidence to date from animal feeding studies with bioengineered plants that the performance of animals differed in any respect from those fed the non-bioengineered counterpart.

Labeling

The FDA has received many inquiries about the labeling of genetically engineered foods. Some consumer advocates and organizations, such as the Union of Concerned Scientists, urge the FDA to require labeling to identify which foods are genetically engineered.

Under the FD&C Act, Congress has provided the FDA a limited basis on which to require labeling. Generally, there must be something tangibly different about the food product — not the process by which it's made — for the FDA to require labeling.

"The FDA has no information that the use of biotechnology creates a class of food that is different in quality, safety or any other attribute from food developed using conventional breeding techniques," says Maryanski. He adds that disclosure of genetic engineering techniques is not required on the label, just as identification of conventional breeding techniques is not required — for example, "hybrid corn" can just be called "corn."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.