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An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate (DBP) Case Study (External Review Draft)
Federal Register Notices
Contact
- Susan Euling
- by phone at: 703-347-8575
- by fax at: 703-347-8692
- by email at: euling.susan@epa.gov
- by fax at: 703-347-8692
Notice
EPA is announcing a 30-day public comment period for the draft document, An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study (External Review Draft), as announced in the May 20, 2009 Federal Register Notice. In addition EPA will convene an independent panel of experts to conduct an external peer-review workshop to review the external review draft report. The deadline for comments is June 19, 2009.
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.Background
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.
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.
History/Chronology
| 2004 | Use of Toxicogenomics in Risk Assessment Approach and Case Study proposal funded by EPA National Center for Computational Toxicology (NCCT). [Science Inventory Description] |
| 2005-2008 | Conducted work on the project with a goal to produce the draft report. |
| Dec 2008 | Conducted internal review of draft report. |
| Jan 2009 | Revised draft report based on internal review comments. |
| May 2009 | EPA released the external review draft for public review and comment. |
Next Steps
- 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.
Downloads/Related Links
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.
- An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study (External Review Draft) (PDF) (268 pp, 7 MB, about PDF)
- Charge to External Peer Reviewers (PDF) (2 pp, 79 KB, about PDF)
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Register for the Workshop
Related Link(s)
Additional Information
Comments on this publication may be submitted and reviewed using the e-Government Regulations.gov website. From the site, select Environmental Protection Agency and the key word EPA- HQ-ORD-2009-0243 (for the docket ID).
Citation
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.
