Risk Assessment

Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology (External Review Draft)

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Cover of the Next Generation of Risk Assessment (External Review Draft) 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.


Lyle Burgoon

phone:  919-541-7808


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.
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.


Feb 2010EPA initiated a Next Generation Risk Assessment (NexGen) program to identify and evaluate recent advances in biological and computational sciences and explore how new data and approaches might be used in risk assessment.
Nov 2010EPA convened a three day expert scientist workshop, called "Advancing the Next Generation (NexGen) of Risk Assessment: The Prototype Workshop," on November 1–3, 2010, in Research Triangle Park, North Carolina. The event was set up to discuss a draft framework, early draft prototypes, research, and other program elements. See the Prototype Workshop Summary Report (PDF, 34 pp, 547Kb).
Feb 2011EPA sponsored a Public Dialogue Conference in Washington, DC, called "Advancing the Next Generation (NexGen) of Risk Assessment." This event engaged the public in the early stages of the NexGen program, help invitees share information, and EPA receive feedback. See the Public Dialogue Conference Summary Report (PDF, 33 pp, 476Kb).
Jun 2012EPA supported and provided NexGen program speakers for an NRC convened workshop (called "Systems Biology – Informed Risk Assessment”) on June 14-15, 2012, in Washington, DC, to discuss emerging sciences in systems biology as tools to inform risk assessment and decision-making and to identify what key issues must be addressed.
Sep 2013EPA releases the draft report, Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology for public review and comment and external peer review. [Federal Register Sep 30, 2013]
Nov 2013EPA extended the public comment deadline 60 more days, the new deadline for comments is January 13, 2014. [Federal Register Notice Nov 13, 2013.

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.


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.
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).