Science Inventory

Developing Computational Tools for Application of Toxicogenomics to Environmental Regulations and Risk Assessment


To address the need for development of tools for managing and analyzing toxicogenomics data, the National Center for Computational Toxicology (NCCT) is working across the Office of Research and Development (ORD), the Program and Regional Offices of EPA, and with other Federal and extramural partners. The NCCT is coordinating it’s toxicogenomics efforts with the rest of the Agency through the SPC’s Genomics Technical Framework and Training Workgroup. This Workgroup has drafted an Interim Guidance for Microarray-Based Assays: Regulatory and Risk Assessment Applications at EPA, that recommends continued collaboration with other federal agencies and stakeholders in developing management and analysis tools for genomics data, and the execution of a series of case studies of genomics applications to chemical prioritization or risk assessment. The NCCT intends to follow these recommendations through a series of projects and partnerships within the Agency, and with the FDA and the STAR-funded Environmental Bioninformatic Centers (EBC) in NC and NJ.


Toxicogenomics is the study of changes in gene expression, protein, and metabolite profiles within cells and tissues, complementary to more traditional toxicological methods. Genomics tools provide detailed molecular data about the underlying biochemical mechanisms of toxicity, and could represent sensitive and precise approaches for detecting effects of exposures, or methods for comparing these effects between species or individuals. Thus genomics, proteomics and metabonomics can provide useful weight-of evidence data along the source-to-outcome continuum, when appropriate bioinformatic and computational methods are applied towards integrating molecular, chemical and toxicological information. The Interim Policy on Genomics ( recognizes that if genomics is to become useful in regulatory decision-making, risk assessment, and environmental monitoring, the Agency will require the computational methods to handle such data. Measuring changes in gene expression using DNA microarrays has proven useful for identifying biological processes and informing hazard identification and mode of action in toxicological research. Similar microarray data have already arisen in Agency environmental decision-making, and regulatory applications of genomics are likely to increase. EPA’s Science Policy Council (SPC) paper on the Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA highlights the potential of toxicogenomics in chemical prioritization and risk assessment. To realize this potential, EPA must have the ability for proper analysis and storage, as well as the computational tools to incorporate these types of data into regulatory decisions. Development of these databases and tools, and application of these various toxicogenomic data within Program and Regional Offices will provide EPA staff with valuable, practical training in genomics and associated disciplines. As toxicogenomics grows more important to environmental science and policy, the NCCT will help EPA develop the computational tools and methods to properly evaluate genomics information.

Record Details:

Record Type:PROJECT
Projected Completion Date:09/30/2008
OMB Category:Other
Record ID: 191847