Preventing adverse health effects by maintaining a safe food supply requires the application of appropriate scientific methods to problems of predicting and identifying unintended compositional changes that may result from genetic modification of plants, animals, and microbes intended for consumption as food. To address this need, the U.S. Department of Agriculture, the U.S. Department of Health and Human Services’ Food and Drug Administration, and the U.S. Environmental Protection Agency asked the National Academies to convene a committee of scientific experts to outline science-based approaches for assessing or predicting the unintended health effects of genetically engineered (GE) foods and to compare the potential for unintended effects with those of foods derived from other conventional genetic modification methods.


This report is intended to aid the sponsoring agencies in evaluating the scientific methods to assess the safety of GE foods before they are sold to the public. The task presented to the committee by the sponsors was to outline science-based approaches to assess or predict unintended health effects of GE foods in order to assist in their evaluation prior to commercialization. The committee was charged to focus on mechanisms by which unintended changes in the biochemical composition of food occur as a result of various conventional and genetic engineering breeding and propagation methods, the extent to which these mechanisms are likely to lead to significant compositional changes in foods that would not be readily apparent without new or enhanced detection methods, and methods to detect such changes in food in order to determine their potential human health effects. The committee was further charged to identify appropriate scientific questions and methods for determining unintended changes in the levels of endogenous nutrients, toxins, toxicants, allergens, or other compounds in food from genetically engineered organisms (GEOs) and outline methods to assess the potential short- and long-term human consequences of such changes.

The committee was charged to compare GE foods with foods derived from other genetic modification methods, such as cross breeding, with respect to the frequency of compositional changes resulting from the modification process and the frequency and severity of the effects of these changes on consumer health. As part of this comparison, the likelihood that elevated toxin or allergen levels would occur in domesticated animals or plants that are modified by different methods was to be considered. Based on this analysis, the committee was charged to discuss whether certain safety issues are specific to GE foods, and if so, recommend approaches for addressing these issues. In addition, the committee was to separately evaluate methods to detect potential unintended compositional changes and health effects of foods derived from cloned animals. The evaluation is presented in a short subreport, separate from, but designed to accompany, the committee’s full-length report on foods derived from genetic modification methods.

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