Recommendation 1: Regulatory agencies should enhance efforts to incorporate toxicogenomic data into risk assessment.

The following actions are needed to move toward this objective:

  1. Substantially enhance agency capability to integrate toxicogenomic approaches into risk assessment practice, focusing on exposure assessment, hazard screening, identification and understanding of variation in human susceptibility, mechanistic insight, assessment of dose-response relationships, cross-species extrapolation, and assessment of mixtures.

  2. Invest in research and expertise within the infrastructure of regulatory agencies as well as active collaboration across agencies.

  3. Develop and expand research programs dedicated to integrating toxicogenomics into challenging risk assessment problems, including the development of public and private sector partnerships.


Fully integrating toxicogenomic technologies into predictive toxicology will require a coordinated effort analogous in concept to the Human Genome Project. Such an effort would, of necessity, be multidisciplinary and multi-institutional and would require broad standardization of technologies and sharing of information. To achieve its goals, such an effort would require funding and resources significantly greater than what are currently allocated to existing research programs and would require partnerships between the public and private sectors.

A national, publicly available database is an essential element of this effort. This is because toxicogenomic technologies generate enormous amounts of data—on a scale even larger than sequencing efforts like the Human Genome Project. Current public databases are inadequate both to manage the types and volumes of data expected to be generated by large-scale applications of toxicogenomic technologies and to facilitate mining and interpretation of the data, which are just as important as their generation and storage. Finally, the ethical, legal, and social implications of collecting, sharing, and using toxicogenomic information are likely to be substantial.

The project as envisioned would require a large-scale, coordinated effort, involving partnerships of government agencies, academic institutions, and commercial organizations. One essential element is to leverage, where possible, large publicly funded studies so they can be used to generate toxicogenomic data. Another essential element is to take steps to facilitate the production and sharing of data between the public and private sectors. Because many of the most extensive applications of toxicogenomic technologies have occurred in the private sector, public-private partnerships will be a vital component of such a large coordinated effort.

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