An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate (DBP) Case Study (External Review Draft)

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This draft report is a description of an approach to evaluate genomic data for use in risk assessment and a case study to illustrate the approach. The dibutyl phthalate (DBP) case study example focuses on male reproductive developmental effects and the qualitative application of the available genomic data. The case study presented in this draft document is a separate activity from any of the ongoing IRIS human health assessments for the phthalates.

Toxicogenomics is the application of genomic technologies (e.g., transcriptomics, genome sequence analysis) to study effects of environmental chemicals on human health and the environment. Currently, EPA provides no guidance for evaluating and incorporating genomic data into risk assessment. Genomic data have the potential to inform mechanism of action, inter- and intra-species toxicodynamic differences, toxicokinetics, and dose-response assessment, depending on the available data.

This draft report describes an approach to evaluating toxicogenomic data for use in risk assessment and a case study of DBP. A multi-disciplinary team of scientists developed the approach for utilizing genomic data in risk assessment and performed the DBP case study. The principles of the approach include examining the genomic and toxicity data sets together, defining a set of questions to direct the evaluation, and performing new analyses of genomic data, when relevant. The draft includes the development of exploratory methods and preliminary results from genomic data analyses. In addition, recommendations, research needs, and potential future directions were identified. The approach and document may serve as a template for evaluating and analyzing genomic data in future chemical assessments and by researchers performing genomic studies.


  • May-Jun 2009: The draft report will undergo external peer review and public comment.
  • Jun 23, 2009: One-day external peer review panel workshop. Click to register!
  • Jun-Jul 2009: The draft report will be revised based on the comments received.
  • Sep 2009: The final report will be released on or about the end of Sep.


U.S. EPA. An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate (DBP) Case Study (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/028A, 2009.


2004Use of Toxicogenomics in Risk Assessment Approach and Case Study proposal funded by EPA National Center for Computational Toxicology (NCCT). [Science Inventory Description]
2005-2008Conducted work on the project with a goal to produce the draft report.
Dec 2008Conducted internal review of draft report.
Jan 2009Revised draft report based on internal review comments.
May 2009EPA released the external review draft for public review and comment.

Additional Information

Comments on this publication may be submitted and reviewed using the e-Government website. From the site, select Environmental Protection Agency and the key word EPA- HQ-ORD-2009-0243 (for the docket ID).

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.