Advancing the Next Generation of Health Risk Assessment

Ila Cote,^1,2 Paul T. Anastas,³ Linda S. Birnbaum,⁴ Rebecca M. Clark,¹ David J. Dix,² Stephen W. Edwards,² and Peter W. Preuss¹

¹U.S. Environmental Protection Agency, Washington, DC, USA; ²U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, USA; ³Yale University, New Haven, Connecticut, USA; ⁴National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services, Research Triangle Park, North Carolina, USA


Abstract

Background: Over the past 20 years, knowledge of the genome and its function has increased ­dramatically, but risk assessment methodologies using such knowledge have not advanced accordingly.


Objective: This commentary describes a collaborative effort among several federal and state agencies to advance the next generation of risk assessment. The objective of the NexGen program is to begin to incorporate recent progress in molecular and systems biology into risk assessment practice. The ultimate success of this program will be based on the incorporation of new practices that facilitate faster, cheaper, and/or more accurate assessments of public health risks.


Methods: We are developing prototype risk assessments that compare the results of traditional, data-rich risk assessments with insights gained from new types of molecular and systems biology data. In this manner, new approaches can be validated, traditional approaches improved, and the value of different types of new scientific information better understood.


Discussion and Conclusions:We anticipate that these new approaches will have a variety of applications, such as assessment of new and existing chemicals in commerce and the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances. Additionally, results of the effort are likely to spur further research and test methods development. Full implementation of new approaches is likely to take 10–20 years.


Key words: bioinformatics, molecular biology, NexGen, “omics,” risk assessment, systems biology. 


Environ Health Perspect 120:1499–1502 (2012). http://dx.doi.org/10.1289/ehp.1104870 [Online 8 August 2012]


Address correspondence to I. Cote, U.S. Environ­mental Protection Agency, 1200 Pennsylvania Ave., NW, MD 8601P, Washington, DC 20460 USA. Telephone: (202) 288-9539. E-mail: cote.ila@epa.gov


We acknowledge the assistance of G. Alexeeff, G. Ankley, J. Avery, S. Barone, L. Burgoon, D. Bussard, W. Chiu, R. Conolly, D. Crawford-Brown, K. Deener, M. DeVito, R. Devlin, R. Dewoskin, H. El Masri, B. Fowler, M. Gilbert, M. Goldsmith, K. Guyton, A. Hubbard, J. Inglese, A. Jerabek, R. Judson, R. Kavlock, T. Knudsen, D. Krewski, J. Lambert, M. Martin, E. Maull, P. McClure, D. Miller, K. Osborn, G. Paoli, E. Perkins, C. Portier, J. Preston, K. Raffaele, K. Ramos, D. Reif, L. Reiter, I. Rusyn, M. Sandy, D. Segal, W. Setzer, I. Shah, L. Sheldon, M. Smith, B. Sonawane, K. Thayer, R. Thomas, R.S. Thomas, R. Tice, J. Vandenberg, D. Villeneuve, J. Wambaugh, N. Wang, S. Wesslekamper, P. White, T. Zacharewski, L. Zeise, H. Zenick, L. Zhang, and J. Zhao.


This manuscript has been reviewed by the U.S. Environmental Protection Agency (EPA) and approved for publication. The views expressed in this manuscript are those of the authors and do not necessarily reflect the views or policies of the U.S. EPA.


The authors declare they have no actual or potential competing financial interests.


Received 17 December 2011; Accepted 8 August 2012; Online 8 August 2012.