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.
1National Center for Environmental Assessment, U.S. Environmental Protection Agency (EPA), Washington, District of Columbia, USA; 2ScitoVation, Research Triangle Park, North Carolina, USA; 3National Health and Environmental Effects Research Laboratory, U.S. EPA, Duluth, Minnesota, USA; 4Office of Chemical Safety and Pollution Prevention, U.S. EPA, Washington, District of Columbia, USA; 5National Institute of Environmental Health Sciences, and 6National Toxicology Program, National Institutes of Health (NIH), Department of Health and Human Services (DHHS), Research Triangle Park, North Carolina, USA; 7Department of Pathology and Laboratory Medicine, Brown University, Providence, Rhode Island, USA; 8Unité Modèles pour l’Écotoxicologie et la Toxicologie, Institut National de l’Environnement Industriel et des Risques, Verneuil en Halatte, France; 9U.S. Army Engineer Research and Development Center, Research Triangle Park, North Carolina, USA; 10Department of Veterinary Integrative Biosciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas, USA; 11Department of Land Economy, University of Cambridge, Cambridge, England; 12National Center for Computational Toxicology, and 13National Health and Environmental Effects Research Laboratory, U.S. EPA, Research Triangle Park, North Carolina, USA; 14International Agency for Cancer Research, Lyon, France; 15George Perkins Marsh Institute, Clark University, Worcester, Massachusetts, USA; 16European Chemicals Agency, Annankatu, Helsinki, Finland; 17McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Ontario, Canada; 18National Center for Environmental Assessment, U.S. EPA, Cincinnati, Ohio, USA; 19National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas, USA; 20Risk Sciences International, Ottawa, Ontario, Canada; 21Department of Biomedical Informatics, Harvard Medical School, Boston, Massachusetts, USA; 22U.S. Army Engineer Research and Development Center, Vicksburg, Mississippi, USA; 23Grant Consulting Group, Washington, District of Columbia, USA; 24Environmental Defense Fund, Washington, District of Columbia, USA; 25Education and Information Division, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Cincinnati, Ohio, USA; 26National Center for Advancing Translational Sciences, NIH, DHHS, Bethesda, Maryland, USA; 27Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, California, USA; 28Gladstone Institutes, University of California, San Francisco, San Francisco, California, USA; 29Systems Toxicology Unit, European Commission Joint Research Centre, Ispra, Italy; 30Center for Effective Government, Washington, District of Columbia, USA; 31Environmental Health Science and Research Bureau, Health Canada, Ottawa, Ontario, Canada; 32Office of Environmental Health Hazard Assessment, California EPA, Oakland, California, USA
Recommended Citation:
Ila Cote,1 Melvin E.,ersen,et al. The Next Generation of Risk Assessment Multi-Year Study—Highlights of Findings, Applications to Risk Assessment, and Future Directions[J]. Environmental Health Perspectives,2016-01-01,Volume 124(Issue 11):1671