Biomarkers of exposure

Much of the motivation for developing more sensitive molecular and genetic biomarkers is to help detect environmental exposures at lower levels than presently is possible.12 These new biomarkers of exposure could reveal human exposures that are presently unknown or could confirm hazards whose presence is merely speculated. In addition, these biomarkers could be used to monitor individuals at risk of exposure, to assess the relationships between ambient exposure levels and internal doses, or to disentangle complex mixtures of exposures into their respective components. Ultimately, the hope is that molecular and genetic biomarkers will allow researchers to pinpoint which exposures are present in a given environment and which of these exposures play an important role in the development of human disease.

There is little doubt that the development of more sensitive biological markers of exposure will help researchers identify harmful human exposures and provide powerful tools for epidemiological research on the biological effects of environmental toxicants.13 Despite those potential benefits, however, the development of new biomarkers of exposure will introduce a number of issues regarding how best to communicate risk-related information to individuals.14 For example, there is a distinct possibility, given exaggerated public views regarding the significance of genetic information, that genetic and molecular biomarkers of exposure will be viewed by laypersons as more accurate or more significant than other sources of information regarding environmental risks.15 Developing effective educational programs to help individuals interpret the significance of biological markers should thus be a key component of biomarkers research.

How environmental policy makers and regulators interpret data from studies of biological markers is also at issue. Traditionally, environmental protection efforts have focused much attention on categories of risks deemed "involuntary" and beyond individual control (e.g., clean air and water), in contrast to risks that individuals "voluntarily" impose on themselves (e.g., health risks associated with cigarette smoke). As more sensitive biological markers of exposure are developed and more environmental hazards identified, this new information is likely to significantly expand an individual's so-called "voluntary" risks by providing more accurate estimates of the harmful effects of particular environments. In other words, by revealing potential risks associated with an individual's choice to remain in a particular environment, the ability to identify individuals and subpopulations at risk from living or working in specific environments will broaden the class of risks deemed voluntary. This new information will force both individuals and environmental policymakers to reexamine the role of human agency in the development of environmentally-induced diseases.

In legal proceedings, the development of new biological markers of exposure will introduce other issues. For example, with respect to tort claims, biomarkers of exposure will likely play a role in establishing causal relationships between environmental hazards and human exposure. Establishing proof of causation in toxic tort cases is notoriously difficult.1617 Not only does a plaintiff have to prove the ability of a compound to cause specific disease or injury (proof of "general causation"), he or she also must prove that the wrongful exposure alleged was the specific cause of plaintiff's injury (proof of "specific causation").

Biomarkers of exposure will play an important role in toxic tort cases by providing both plaintiffs and defendants with additional tools to establish or undermine claims about cause-and-effect relationships. For example, a plaintiff might introduce evidence of a chemical-specific biomarker of exposure to prove that he or she was wrongfully exposed to a defendant's compound. Alternatively, a defendant may introduce evidence of a biomarker of exposure to prove that a plaintiff was exposed to a chemical other than the one alleged. In the second scenario, the introduction of such evidence could support an alternate theory of causation for a plaintiff's injuries that may relieve the defendant of any legal liability.

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