This potential has prompted a plethora of scientific reviews and commentaries about toxicogenomics written over the past several years that attest to the widely held expectation that toxicogenomics will enhance the ability of scientists to study and estimate the risks different chemicals pose to human health and the environment. However, there are limitations in the data that are currently available, and fully understanding what can be expected from the technologies will require a greater consolidation of useful data, tools, and analyses. Given the inherent complexity in generating, analyzing, and interpreting toxicogenomic data and the fact that toxicogenomics cannot address all aspects of toxicology testing, interested parties need to prepare in advance. This preparation will help them understand how best to use these new types of information for risk assessment and for implementing commensurate changes in regulations and public health, while preparing for the potential economic, ethical, legal, and social consequences.


In anticipation of these questions, the National Institute of Environmental Health Sciences (NIEHS) of the U.S. Department of Health and Human Services, asked the National Academies to direct its investigative arm, the National Research Council (NRC), to examine the potential impacts of toxicogenomic technologies on predictive toxicology. NIEHS has invested significant resources in toxicogenomic research through establishment of the National Center for Toxicogenomics, funding of the National Toxicogenomics Research Consortium, development of the Chemical Effects in Biological Systems database for toxicogenomic data, and other collaborative ventures.

In response to the NIEHS request, the NRC assembled a panel of 16 experts with perspectives from academia, industry, environmental advocacy groups, and the legal community. The charge to the committee was to provide a broad overview for the public, government policy makers, and other interested and involved parties of the benefits potentially arising from toxicogenomic technologies; to identify the challenges in achieving them; and to suggest approaches that might be used to address the challenges.


The committee clarified its task by defining the terms “toxicogenomics” and “predictive toxicology” as follows:

  • Toxicogenomics is defined as the application of genomic technologies (for example, genetics, genome sequence analysis, gene expression profiling, proteomics, metabolomics, and related approaches) to study the adverse effects of environmental and pharmaceutical chemicals on human health and the environment. Toxicogenomics combines toxicology with information-dense ge-

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