[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Page 1770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-486]




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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.


SUMMARY: 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 

ADDRESSES: The document will be available electronically through the 
NCEA Web site at www.epa.gov/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: 
lmit.com">[email protected]lmit.com. Please provide your name, your mailing address, the 
title and the EPA number of the requested publication.

FOR FURTHER INFORMATION CONTACT: 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: [email protected].

    Dated: October 27, 2009.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 2010-486 Filed 1-12-10; 8:45 am]