The next generation of risk assessment multi-year study–highlights of findings, applications to risk assessment, and future directions

Ila Cote, Melvin E. Andersen, Gerald T. Ankley, Stanley Barone, Linda S. Birnbaum, Kim Boekelheide, Frederic Y. Bois, Lyle D. Burgoon, Weihsueh A. Chiu, Douglas Crawford-Brown, Kevin M. Crofton, Michael Devito, Robert B. Devlin, Stephen W. Edwards, Kathryn Z. Guyton, Dale Hattis, Richard S. Judson, Derek Knight, Daniel Krewski, Jason LambertElizabeth Anne Maull, Donna Mendrick, Gregory M. Paoli, Chirag Jagdish Patel, Edward J. Perkins, Gerald Poje, Christopher J. Portier, Ivan Rusyn, Paul A. Schulte, Anton Simeonov, Martyn T. Smith, Kristina A. Thayer, Russell S. Thomas, Reuben Thomas, Raymond R. Tice, John J. Vandenberg, Daniel L. Villeneuve, Scott Wesselkamper, Maurice Whelan, Christine Whittaker, Ronald White, Menghang Xia, Carole Yauk, Lauren Zeise, Jay Zhao, Robert S. Dewoskin

Research output: Contribution to journalReview articlepeer-review

48 Scopus citations


Background: The Next Generation (NexGen) of Risk Assessment effort is a multi-year collaboration among several organizations evaluating new, potentially more efficient molecular, computational, and systems biology approaches to risk assessment. This article summarizes our findings, suggests applications to risk assessment, and identifies strategic research directions. Objective: Our specific objectives were to test whether advanced biological data and methods could better inform our understanding of public health risks posed by environmental exposures. Methods: New data and methods were applied and evaluated for use in hazard identification and dose-response assessment. Biomarkers of exposure and effect, and risk characterization were also examined. Consideration was given to various decision contexts with increasing regulatory and public health impacts. Data types included transcriptomics, genomics, and proteomics. Methods included molecular epidemiology and clinical studies, bioinformatic knowledge mining, pathway and network analyses, short-duration in vivo and in vitro bioassays, and quantitative structure activity relationship modeling. Discussion: NexGen has advanced our ability to apply new science by more rapidly identifying chemicals and exposures of potential concern, helping characterize mechanisms of action that influence conclusions about causality, exposure-response relationships, susceptibility and cumulative risk, and by elucidating new biomarkers of exposure and effects. Additionally, NexGen has fostered extensive discussion among risk scientists and managers and improved confidence in interpreting and applying new data streams. Conclusions: While considerable uncertainties remain, thoughtful application of new knowledge to risk assessment appears reasonable for augmenting major scope assessments, forming the basis for or augmenting limited scope assessments, and for prioritization and screening of very data limited chemicals.

Original languageEnglish (US)
Pages (from-to)1671-1682
Number of pages12
JournalEnvironmental health perspectives
Issue number11
StatePublished - Nov 2016

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health, Toxicology and Mutagenesis


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