Application of Biomarkers to Environmental Health and Risk Assessment
The U.S. Environmental Protection Agency (EPA) Office of Research and Development, National Center for Environmental Research (NCER), through its Science to Achieve Results (STAR) program, is issuing this request for applications (RFA) for research that provides validation, interpretation, and/or application of currently known biomarkers to environmental health and risk assessment. Of special interest is the utilization of multiple biomarkers that can fill knowledge gaps across different points of the exposure--dose--effect continuum and/or that can be applied in a clinical setting. The proposals should focus on one or more of the following investigational areas:
1) Animal or epidemlology studies that explore the relationship between biomarkers of exposure and measures of subclinical disease (early biological effect or altered structure/function). Additionally, these studies could be expanded to explore the relationship between the subclinical disease measure and the actual clinical disease.
2) Mechanistic studies (e.g., using genomics or proreomics) of toxicant response linked to clinical disease--for example, the identification of the functional relevance of proteins where genetic polymorphisms have been found to modify the effect of an environmental exposure on a disease end point.
3) Studies to validate the utility of biomarkers for use in large population studies (e.g., reliability, predictive value, sensitivity, specificity, affordability, applicability to the general population and susceptible subpopulations).
Risk assessment is an essential tool for setting environmental and occupational standards that limit exposure to environmental agents with the aim of protecting human health. However, risk assessment is a relatively new discipline, and currently available methods and detailed information on exposure and toxicity are frequently inadequate to fully satisfy, the demands for accurate risk characterization. More information is needed regarding the events leading from exposure to dose to effect. Biological markers have significant potential for strengthening current risk assessments, for example, by filling in important gaps in the exposure--disease continuum.
Although the field of biomarkers is still relatively new, many different analytical techniques have been developed to quantify such events as exposure to a certain chemical or early biological events resulting from exposures. Problems exist with many current biomarkers in that they, have not been validated for use in large population studies, and their significance for predicting the risk of clinical disease is unknown. …