[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Notices]
[Page 1770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-486]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-9094-9]
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.
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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
assessment.
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">nscep@bps-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]
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