^®: CRE Regulatory Action of the Week

EPA Publishes Final Toxicogenomic Risk Assessment Guidance
On January 13, 2010, the U.S. Environmental Protection Agency published in the Federal Register EPA's final report titled, "An Approach to Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl Phthalate Case Study." This seminal report lays out EPA's process for using toxicogenomics in risk assessments.

EPA's Federal Register notice explains that

"[t]oxicogenomics 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).


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"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."