An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study (Final Report) 2009

Notice

EPA is announcing the release of the final report, An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study.


Abstract

Cover of the Dibutyl Phthalate (DBP) Case Study Report This final 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 genomic data because of the available data on DBP. The case study presented in this 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(s) and mode(s) of action, inter- and intra-species toxicodynamic differences, toxicokinetics, and dose-response assessment, depending on the available data.

This final 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 report includes the development of exploratory methods and preliminary results from genomic data analyses. In addition, recommendations, research needs, and future directions for applying genomic data to risk assessment were identified. The approach and case study may be used as a template for evaluating and analyzing genomic data in future chemical assessments as well as by researchers performing genomic studies for use in risk assessment.

Status

This is the Final Report.

Citation

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

History/Chronology

2004Use of Toxicogenomics in Risk Assessment Approach and Case Study proposal funded by EPA National Center for Computational Toxicology (NCCT). [Science Inventory Description]
May 2009EPA released the external review draft for public review and comment.
Sep 2009EPA released the Final Report.

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