Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology (Final Report)

EPA announced the release of the final report, Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology. This report describes new approaches that are faster, less resource intensive, and more robust that can help address the challenges of assessing potential health hazards for large number of chemicals introduced into the environment and to evaluate their safety from the perspective of human health. This report describes 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.

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.
Agency Partners

  • Army Corps of Engineers
  • California Environmental Protection Agency, Office of Environmental Health Hazard Assessment:
  • Centers for Disease Control, National Center for Environmental Health, and the Agency for Toxic Substances and Disease Registry
  • Department of Defense, Office of the Secretary of Defense
  • European Chemicals Agency
  • European Joint Research Commission
  • FDA’s National Center Toxicological Research
  • Health CanadaL'Institut National de l'Environnement Industriel et des Risques
  • National Institutes of Health National Center for Advancing Translational Science
  • National Institute of Environmental Health Sciences and the National Toxicology Program
  • National Institute for Occupational Safety and Health

Citation

U.S. EPA. Next Generation Risk Assessment: Incorporation of Recent Advances in Molecular, Computational, and Systems Biology (Final Report). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-14/004, 2014.

History/Chronology

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 helped plan and participated in NRC Emerging Sciences for Environmental Health Decisions Committee 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.
Sep 2014EPA released the final report.

This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.