Frequently Asked Questions On Agricultural Biotechnology

Are foods produced using biotechnology as safe to eat as foods produced using traditional breeding practices?
Yes. For over two decades, the products of biotechnology have been assessed for safety using science-based regulatory and nonregulatory mechanisms developed over the last half century for all crop plants. Biotechnology plants and foods are among the most tested in history.

A number of prestigious U.S. and international scientific bodies - such as the U.S. National Academies of Science, the United Nations Food and Agriculture Organization (FAO), the World Health Organization, the Organization for Economic Cooperation and Development (OECD), the American Medical Association (AMA), the American Dietetic Association, the Council on Agricultural Science and Technology (CAST), the Institute for Food Technologists, the International Council for Science (ICSU) and the British Medical Association – have determined that biotech crops are as safe as similar crops improved through traditional and organic breeding methods. A 2004 report by the National Academies, for example, found that biotech crops do not pose any more health risks than do crops created by other techniques and that food safety evaluations should be based on the resulting food product, not the technique used to create it."

Indeed, because scientists know more about the changes being made using biotechnology, these foods may be even safer than conventional foods. The precision of biotechnology puts plant developers and regulators are in a better position to address safety that cannot be addressed for products of conventional breeding, which involves the uncontrolled crossing of tens of thousands of uncharacterized genes.

Federal regulatory agencies also ensure the safety of biotechnology foods. To date, no approved biotechnology food has harmed human health.

To learn more about the safety of agricultural biotechnology food products, click here.

Are the products of agricultural biotechnology regulated?
Yes. The U.S. regulatory system, which enjoys a high degree of public confidence, employs rigorous scientific reviews within a transparent decision-making framework open to public participation. This regulatory approach provides full access to documents on which decisions are based and is carried out completely in the public eye as required by law. The science-based U.S. regulatory system has helped ensure that biotechnology products are safe for producers, consumers, and the environment.

Biotechnology products in the United States are regulated according to a system, the Coordinated Framework, established by the Office of Science and Technology Policy in 1986. Deriving its mandate from existing laws regulating food safety and agriculture, the Coordinated Framework assigns lead responsibility for biotechnology products to the appropriate regulatory agency and sets out principles for cooperative reviews in areas where responsibilities or authorities overlap. The regulation of agricultural biotechnology products is handled by three agencies:

• U.S. Department of Agriculture Animal and Plant Health Inspection Service - APHIS oversees the field-testing of biotechnology-derived plants as "regulated articles" to ensure that the environment is protected. A petition for nonregulated status must be granted by APHIS prior to commercial growth and sale of any bioengineered crop.
• The Environmental Protection Agency - The EPA is responsible for ensuring that pest-resistant biotech varieties are safe to grow and consume. It regulates environmental exposure to these crops to ensure there are no adverse effects to the environment or any beneficial, nontargeted insects and other organisms. The agency also regulates bioengineered microorganisms under the Toxic Substances Control Act.
• Food and Drug Administration, Center for Food Safety and Nutrition - The FDA imposes on foods developed through biotechnology the same regulatory requirements FDA uses to safeguard all foods in the marketplace. The FDA has both premarket and postmarket authority to regulate the safety and labeling of all foods and animal feed. Foods from biotechnology are judged on their individual safety and nutrition, not the methods used to produce them. Under federal law, the producer of a food has the legal obligation to ensure its safety to consumers, and FDA may pull from the market any foods found to be unsafe. Since 1992, FDA has used a voluntary review process for biotechnology foods. Over 50 such products have been reviewed, and none has been found to pose a safety concern. To improve consumer confidence, proposed rules issued by FDA in 2001 would make premarket review of biotech foods mandatory.

To learn more about the regulations governing agricultural biotechnology, click here.

Do foods produced using biotechnology require special labeling?
No. The FDA applies the same labeling standards to foods produced through biotechnology that are applied to all foods produced using traditional methods. Federal law requires labeling of a new food to inform consumers when there are significant changes in nutrition, safety or usage, or if the common name of the food no longer applies.

The FDA's evaluation of a biotechnology food focuses on its characteristics, not the method used to develop it. A new biotechnology food that is "substantially equivalent"-that is, has a similar composition and nutritional value-to similar varieties currently on the market would not require a special label because it would not provide the consumer with material information on the new food's safety or nutritional value.