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National Academy Releases Report On Incorporating
Emerging Science In Risk Assessment

In the current age of big data sets and increased computational power, many scientific fields are now faced with new tools and the challenges that come along with them. In the context of human health risk as a result of chemical exposure, risk has historically been assessed using animal models extrapolated to human scenarios. Many of the limitations to this approach are being addressed by recent advancements in a host of technologies that allow researchers to ask entirely new and complex questions to better assess the risk posed by environmental and chemical exposures.

Addressing the Advancement of Chemical Risk Assessment
Published in early January, a National Academies of Sciences, Engineering, and Medicine report outlines the very advancements that are improving and complementing the data from whole animal models such as new genetic techniques, high-throughput in vitro tests, and computational modeling. Chair of the report committee, Jonathan Samet, epidemiologist at the University of Southern California,  says the report "... identifies critical challenges to be addressed in using 21st century science to better characterize the risks of chemicals for human health." Data from these new approaches can improve risk evaluations by doing a better job of accounting for the high degree of disease complexity related to exposure and causation.

Building on Increased Awareness
The report comes on the heels of twoprevious reports (Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy). Written at a time when many began to realize how the advancements in biology and basic science might improve our understanding of chemical risk, these two reports spurred the scientific community to apply more advanced methods to chemical risk evaluation. Knowing the full potential of the new techniques and data now rapidly being generated, last month’s National Academy Report was commissioned to “recommend the best ways to incorporate the emerging science into risk-based evaluations.” Sponsored by the U.S. Environmental Protection Agency, U.S. Food And Drug Administration, National Institute of Environmental Health Sciences, and National Center for Advancing Translational Sciences, the report focuses on the scientific advances impacting several related fields: Exposure Science, Toxicology, and Epidemiology.  Within each field, technology is driving new directions with respect to integrating emerging evidence that will improve the four elements of risk assessment: hazard identification, dose-response assessment, exposure assessment, and risk characterization.

Examples of 21st Century Science
Molecular advancements in -omics technologies are allowing scientists to get a better understanding of the mechanistic basis of biological responses, and identify biomarkers of exposure that are critical in connecting the dots from exposure to outcome.  Computational advances are improving the ability to estimate risk from novel chemicals and exposures and probe chemical interactions, as well as helping model the intricacy of individual responses based on multi-route exposure and physiological variability.  Lastly, new analytical techniques and assays are helping characterize chemical and environmental exposures by both broadening the scope of chemical exposure data (non-targeted analyses) and also improving targeted analyses.

Impact on Epidemiology
Epidemiology, due to its interdisciplinary nature, is benefiting from developments in all of the above areas. Molecular advancements in the -omics technologies (in particular) are changing the way epidemiology is practiced and strengthening our understanding of the biological plausibility of exposure and disease.  While genome wide association studies have been helpful in understanding the genetic basis disease in some situations, now epigenomics, proteomics, transcriptomics, and metabolomics are adding enormous amounts of additional data for epidemiologists to consider in their efforts to improve public health.

Integration of Advanced Approaches
Advanced approaches can be combined with powerful results, but as the field matures these advanced techniques necessitate a host of new solutions in and of themselves. For example, new statistical methods must be used to properly analyze and interpret the data.  Infrastructure needs to be in place to handle the loads of samples and biobank data produced by these integrative studies.  Harmonization and validation of platforms and results is required to not only assist with basic data comparison but also to potentially allow for better data-sharing and powerful meta-analyses.  And perhaps more importantly, it also requires collaborations between experts to complete the picture.

A Multidisciplinary Path Forward
The report summary concludes by emphasizing this last piece; the necessity for a multidisciplinary approach. “Exposure scientists, toxicologists, epidemiologists, and scientists in other disciplines need to collaborate closely to ensure that the full potential of 21st century science is realized to help to solve the complex environmental and public-health problems that society faces.”  Data generation and collection is occurring at an unprecedented pace and the only way to keep up will be for the experts to work together to tackle these challenges. “Although the challenges to achieving the visions of the earlier reports often seem daunting, 21st century science holds great promise for advancing risk assessment and ultimately for improving public health and the environment.”

EurekAlert! Coverage:

Link to Report:      ■

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