The U.S. Food and Drug Administration (FDA), which has statutory authority for protecting the safety and quality of the food supply, provides the oversight for genetically modified foods cultivated and marketed within the American agricultural system. This article examines the FDA's policies on genetically modified foods including its voluntary consultation program and its proposed rule on premarket notification and data submission. The FDA's consultations of foods modified for delayed ripening and herbicide tolerance are reviewed. The article also discusses the FDA's science-based approach for evaluating whether there are any potential adverse health effects of genetically modified food products. The agency has chosen an approach to risk assessment that takes account of both product characteristics and the process through which the food is developed.
Bergelson, Joy, Colin B. Purrington, Curtis J. Palm, and Juan-Carlos López-Gutiérrez .1996. Costs of resistance: A test using transgenic Aradopsis thaliana. Proceedings of the Royal Society of London, Series B 263:1659-63.
3.
Conner, A.J., and J.M.E. Jacobs.1999. Genetic engineering of crops as potential sources of genetic hazard in the human diet. Mutation Research443:223-34.
4.
Finding a future for GM crops. 2001. Nature414:1.
5.
Food and Drug Administration (FDA).1992. Statement of policy: Foods derived from new plant varieties. Federal Register57:22984-23002. Retrieved from http://www.cfsan.fda.gov/∼lrd/bio1992.html.
6.
—. 2001. Premarket notice concerning bioengineered foods: Proposed rule. Federal Register66:4706-38. Retrieved from http://www.cfsan.fda.gov/∼lrd/fr010118.html.
7.
Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition.1997. Guidance on consultation procedures: Foods derived from new plant varieties. Retrieved from http://www.cfsan.fda.gov/∼lrd/consulpr.html.
8.
Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition, Office of Food Additive Safety.2002. List of completed consultations on bioengineered foods. Retrieved from http://www.cfsan.gov/∼lrd/biocon.html.
9.
Food and Drug Administration (FDA), Joint CFSAN/CVM Advisory Committee Meeting. 1994. Procedures for industry-FDA interaction prior to commercial distribution of foods derived from new plant varieties developed using recombinant DNA techniques . Retrieved from http://vm.cfsan.fda.gov/∼lrd/biopro.html .
10.
Griffiths, Anthony J. F., Jeffrey H. Miller, David T. Suzuki, Richard C. Lewontin, and William M. Gelbart .1996. An introduction to genetic analysis. 6th ed. New York: Freeman.
11.
Haslberger, Alexander G.2000. Monitoring and labeling for genetically modified products . Science287:431.
12.
Ho, Mae-Wan.1998. Genetic engineering: Dream or nightmare? Bath, UK: Gateway.
13.
Kessler, David A., Michael R. Taylor, James H. Maryanski, Eric L. Flamm, and Linda S. Kahl.1992. The safety of foods developed by biotechnology . Science256:1747-49, 1832.
14.
Miller, Henry I.1999. Substantial equivalence: Its uses and abuses. Nature Biotechnology17:1042-43.
15.
Millstone, Erik, and Sue Mayer. 1999. Beyond "substantial equivalence." Nature401:525-26.
16.
National Academy of Sciences, Committee on the Introduction of Genetically Engineered Organisms into the Environment . 1987. Introduction of recombinant DNA-engineered organisms into the environment: Key issues. Washington, DC: National Academy Press.
17.
National Academy of Sciences, National Research Council, Committee on Genetically Modified Pest-Protected Plants.2000. Genetically modified pest-protected plants: Science and regulation. Washington, DC: National Academy Press.
18.
National Academy of Sciences, National Research Council, Committee on the Scientific Evaluation of the Introduction of Genetically Modified Microorganisms and Plants into the Environment.1989. Field testing genetically modified organisms: Framework for decisions. Washington, DC: National Academy Press.
19.
Novak, W.K., and A.G. Haslberger .2000. Substantial equivalence of antinutrients and inherent plant toxins in genetically modified novel foods . Food and Chemical Toxicology38:473-83.
20.
Regal, Philip.1994. Scientific principles for ecologically based risk assessment of transgenic organisms. Molecular Ecology3:5-13.
21.
Wal, J.M.2001. Biotechnology and allergic risk. Revue Francaise d'Allergologie et d'Immunologie Clinique41:36-42.
