US EPA

EPA is releasing a draft report "Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology" that explores how new molecular, computational and systems biology data and approaches (together called "NexGen") could better inform risk assessment. The report summarizes the state of the science and provides prototypes, which are case studies that use available NexGen information. This draft report will be available for public review and comment and will undergo independent external peer review.

The landscape of chemical risk assessment is rapidly changing as a result of phenomenal advances in molecular systems biology, reports from the National Research Council, improved understanding of gene-environment interactions, and volumes of new toxicity data from the United States and Europe. In response, EPA initiated the “Advancing the Next Generation of Risk Assessment” (NexGen) effort, which aims to create a faster and more cost effective system for chemical risk assessment by incorporating new chemical testing data and advances in molecular and systems biology technologies. This effort involves the National Institutes of Environmental Health Sciences, the Centers for Disease Control and Prevention, National Institutes of Occupational Health and Safety, the Food and Drug Administration’s National Center for Toxicological Research, the National Human Genome Research Institute, California’s Environmental Protection Agency, the European Chemical Agency and the European Joint Research Center, as well as several academic institutions.

This document presents the results and lessons learned from the prototypes/case studies for use of molecular, computational, and systems biology data in risk assessment. The prototype results demonstrated proof of concept for an integrated approach to incorporating molecular, computational, and systems biology data in risk assessment and considered various data types for specific assessment purposes. The lessons learned from this project suggested research needs and near- and longer-term implications of incorporating molecular, computational, and systems biology data in risk assessment.

After receiving comments from peer reviewers and the public on this draft report, EPA will revise the draft report to incorporate the input received. When final, the report will help inform the use of new information, such as advances in genetics, molecular biology, and computational and systems biology, in risk assessments.

U.S. EPA. Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-13/214A, 2013.

Comments on the assessment may be submitted and reviewed using the e-Government Regulations.gov Web site. From the site, select Environmental Protection Agency and the key word EPA-HQ-ORD-2013-0680 (for the docket ID).