Food Safety Assessment of Genetically Modified Crops

well known in rats fed similar diets, and that the sample size (six rats) was too small to draw any conclusions. Following the production of the first transgenic plants, health issues The report by Ewen and Pusztai (1999) was seized concerning the safety of using genetically modified (GM) crops in foods and feeds have been discussed, debated, and evaluated. The upon by anti-GM advocates to support their contention main concerns regarding GM foods include toxin or allergen producthat proper regulatory oversight is either lacking or intion, changes in nutrient levels, and development of antibiotic resisadequate. This paper was written to address those contance. The U.S. Food and Drug Administration established extensive cerns and to provide information on the assessment guidelines to address the concerns and ensure the safe commercial criteria and regulatory mechanisms that are in place in introduction of GM crops for use in food or feed. The guidelines the U.S. to ensure the safety of GM foods. were developed through evaluation of scientific data from several disciplines related to genetic engineering and food safety, and consulSafety Assurance for Foods Derived tation with experts from around the world. Foods containing GM from Genetically Modified Crops crops meeting the FDA guidelines are deemed to be as safe and nutritious as their non-GM counterparts already on the market. Before marketing, GM crops must undergo extensive food, feed, and environmental safety assessments. The Food and Drug Administration (FDA), the U.S. EnviI the 5 yr since the first large-scale commercial harronmental Protection Agency (USEPA), and the U.S. vest, the area planted to transgenic crops in the U.S. Department of Agriculture’s (USDA) Animal and Plant has grown to more than 28.4 million ha (more than 71 Health Inspection Service (APHIS) all have jurisdiction million acres) in 1999, where approximately 35% of all for monitoring and regulating the development, testing, corn (Zea mays L.) and 55% of all soybean [Glycine and release of GM plants and plant products. max (L.) Merr.] planted were transgenic (James, 1999). The Federal Food, Drug, and Cosmetic Act grants Because soybean and corn are used as ingredients in a the FDA authority to regulate commercialization and wide range of food products, many foods on grocery marketing of most domestic and imported foods in the store shelves currently contain ingredients derived from U.S. market. Under the 1992 Policy interpretation (USgenetically engineered crops. Barring a consumer backFDA, 1992), GM foods and food ingredients must comlash, the area planted to transgenic crops will continue ply with the same standards that apply to other food to rise, resulting in ever more foods derived from transproducts. This means that GM foods must be as safe genic crops (GM foods) in the marketplace. and nutritious as their non-GM counterparts in grocery Throughout the development and commercialization stores today. The Act places legal duty on developers of transgenic crops, health and food safety concerns to ensure that the foods they market to consumers are have been raised and regulatory procedures established safe to eat. Transgenic crops containing novel proteins to ensure the safety of GM foods. The main concerns classified as food additives are subjected to additional voiced have been questions about the potential of GM testing and must receive premarket approval by the crops to: FDA before commercialization, while whole foods made from transgenic crops passing GRAS (generally • Inadvertently introduce toxins recognized as safe) standards are subject to FDA regula• Introduce allergens tion after commercialization. The FDA has the broad • Change the levels of essential nutrients, and/or authority to take legal action against developers of any • Compromise antibiotic therapies food or food additive that poses a hazard to the public. Issues of food safety from GM crops came to the fore The FDA published its 1992 policy to assist developwith a report that a greater number of laboratory rats ers in addressing food safety and regulatory issues be(Rattus rattus) suffered from abnormalities in their small fore products reach the market. The policy statement intestines after 10 d of feeding on GM potato diets contains a comprehensive “guidance to industry” sec(Solanum tuberosum L.), relative to those feeding on tion that discusses scientific issues for assuring food non-GM potato diets (Ewen and Pusztai, 1999). In an safety and identifies scientific and regulatory questions extraordinarily unusual step within the scientific field, that developers must consider to determine if they the same journal that published the paper simultaneshould consult with the FDA before commercial release ously published the rebuttal (Kuiper et al., 1999). The of a genetically engineered food crop. Developers are rebuttal made it clear that the potato diet was inapproencouraged to consult with the FDA through the Office priate for rats, that similar intestinal abnormalities are of Premarket Approval of the Center for Food Safety Abbreviations: GM, genetically modified; FDA, Food and Drug AdDepartment of Agronomy, Univ. of Wisconsin, 1575 Linden Dr., ministration; USEPA, U.S. Environmental Protection Agency; Madison, WI 53706. Received 31 Jan. 2000. *Corresponding author USDA, U.S. Department of Agriculture; APHIS, Animal and Plant (hfkaeppl@facstaff.wisc.edu). Health Inspection Service; GRAS, generally recognized as safe; ECSCF, European Commission Scientific Committee for Food. Published in Agron. J. 92:793–797 (2000).