The Society of Toxicology (SOT) is committed to protecting and enhancing human, animal, and environmental health through the sound application of the fundamental principles of the science of toxicology. It is with this goal in mind that the SOT defines here its current consensus position on the safety of foods produced through biotechnology (genetic engineering). These products are commonly termed genetically modified foods, but this is misleading, since conventional methods of microbial, crop, and animal improvement also produced genetic modifications and these are not addressed here. The available scientific evidence indicates that the potential adverse health effects arising from biotechnology-derived foods are not different in nature from those created by conventional breeding practices for plant, animal, or microbial enhancement, and are already familiar to toxicologists. It is therefore important to recognize that the food product itself, rather than the process through which it is made, should be the focus of attention in assessing safety. We support the use of the substantial equivalence concept as part of the safety assessment of biotechnology-derived foods. This process establishes whether the new plant or animal is significantly different from comparable, nonengineered plants or animals used to produce food that is generally considered to be safe for consumers. It provides critical guidance as to the nature of any increased health hazards in the new food. To establish substantial equivalence, extensive comparative study of the chemical composition, nutritional quality, and levels of potentially toxic components, in both the engineered and conventional crop and animal, are conducted. Notable differences between the existing and new organism would require further evaluation to determine whether the engineered form presents a higher level of risk. Through this approach, the safety of current biotechnology-derived foods can be compared with that of their conventional counterparts, using established and accepted methods of analytical, nutritional, and toxicological research. Studies of this type have established that the level of safety to consumers of current genetically engineered foods is likely to be equivalent to that of traditional foods. At present, no verifiable evidence of adverse health effects of BD foods has been reported, although the current passive reporting system probably would not detect minor or rare adverse effects or a moderate increase in effects with a high background incidence such as diarrhea. The changes in the composition of existing foods produced through biotechnology are quite limited. Assessing safety may be more difficult in the future if genetic engineering projects cause more substantial and complex changes in a foodstuff. Methods have not been developed with which whole foods (in contrast to single chemical components) can be fully evaluated for safety. Progress also needs to be made in developing definitive methods for the identification and characterization of proteins that are potential allergens, and this is currently a major focus of research. Improved methods of profiling plant and microbial metabolities, proteins and gene expression may be helpful in detecting unexpected changes in BD organisms and in establishing substantial equivalence. A continuing evolution of toxicological methodologies and regulatory strategies will be necessary to ensure that the present level of safety of biotechnology-derived foods is maintained in the future.