Skip to Content


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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Environmental Protection Agency (EPA).


Notice of availability.


EPA is announcing the availability of a final report titled, “An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study” (EPA/600/R-09/028F), which was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD).

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. This report describes an approach to evaluate toxicogenomic data for use in risk assessment and a case study for dibutyl phthalate (DBP). A multidisciplinary team of scientists developed the approach and performed the case study. In this approach, the genomic data and the human outcome and/or toxicity data are considered together to determine the relationship between genomic changes and toxicity or health outcomes and inform mechanisms and modes of toxicity. The DBP case study focuses on male reproductive developmental effects and the use of genomic data in qualitative aspects of the risk assessment because of the type of genomic data available for DBP. It is important to note that the case study presented in this report is a separate activity from any of the ongoing IRIS human health assessments for the phthalates.

The final report includes the development of exploratory methods for analyzing genomic data for application to risk assessment and some preliminary results. In addition, recommendations for risk assessors, research needs, and future directions for generating and applying genomic data in risk assessment are described. The approach and case study may be used as a template for evaluating and analyzing genomic data in future chemical assessments and the methods and research needs may be used by researchers performing genomic studies for use in risk assessment.


The document will be available electronically through the NCEA Web site at​ncea. A limited number of paper copies will be available from the EPA's National Service Center for Environmental Publications (NSCEP), P.O. Box 42419, Cincinnati, OH 45242; telephone: 1-800-490-9198; facsimile: 301-604-3408; e-mail: Please provide your name, your mailing address, the title and the EPA number of the requested publication.

Start Further Info


The Information Management Team, National Center for Environmental Assessment (8601P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Telephone: 703-347-8561; fax: 703-347-8691; e-mail:

Start Signature

Dated: October 27, 2009.

Peter W. Preuss,

Director, National Center for Environmental Assessment.

End Signature End Further Info End Preamble

[FR Doc. 2010-486 Filed 1-12-10; 8:45 am]