tion, and the U.S. Environmental Protection Agency—asked the National Academies to convene a committee that would outline science-based approaches to assess or predict the unintended health effects of GE foods to aid in evaluating these products before they are sold to the public. The committee was charged with identifying appropriate scientific questions and methods for determining unintended changes in the levels of nutrients, toxins, toxicants, allergens, or other compounds in food from GEOs and outlining methods to assess the potential short- and long-term human health consequences of such changes.

The agencies also asked the committee to compare GE food with food derived from other genetic modification methods, such as crossbreeding, with respect to the frequency of compositional changes and the frequency and severity of the effects of these changes on consumer health. Finally, the committee was asked to discuss whether certain safety issues are specific to GE food and, if so, to recommend approaches for addressing these issues.

The committee’s charge did not include evaluating or making recommendations about policy issues, such as labeling GE foods, segregating foods in commerce, or preventing cross-contamination of foods.

Approach to the Task

The committee approached its task by gathering information from existing literature and from public workshop presentations by recognized experts (see Appendix B for the workshop agendas) and then deliberating on issues relevant to their charge.

From these discussions, the committee developed a theoretical framework for identifying appropriate comparators for GE and other GM foods, increasing scientific understanding of the determinants of compositional variability among foods, increasing understanding of the biological effects of secondary metabolites in food, developing more sensitive techniques for assessing potential unintended effects from food modification, and improving methods for tracking and tracing exposure in genetically modified food.

The committee’s deliberations about identifying appropriate comparators for GE food clarified that while such comparisons are necessary, they alone are not sufficient for determining the likelihood of producing an unintended adverse health effect. Consequently, this report focuses on an array of complementary science-based approaches for predicting and assessing unintended health effects of GE food and for evaluating the mechanisms by which unintended effects occur as a result of genetic modification.

Organization of the Report

This report is organized into seven chapters and an accompanying subreport on animal genetic manipulation and cloning. Chapter 2 describes the molecular

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