The interpretation of chemical epidemiology studies requires integration with experts on the nature of the reported adverse outcome and toxicologists

Abstract

Chemical Epidemiology Studies (CES) can be both protective for humans of adverse health effects of chemicals as well as cause alarm leading to unwarranted remedial action and litigation. Inherent problems in conducting CES especially related to the study design goals and assessment of exposure are recognized. Many CES report adverse health outcomes at very low exposure levels implying that humans are uniquely or especially sensitive to the toxicity of these chemicals. Such unique sensitivity to humans would be especially important to scientists in human physiology, medical and toxicology communities. CES are currently appearing in the open literature more frequently and it is expected that they will be appearing even more frequently in the future especially if animal toxicity testing is reduced or eliminated. Experts on the nature of the reported adverse health outcomes should be playing a more critical role in the interpretation of CES because they are best suited to understand the many factors affecting natural and induced variability. Should animal toxicity testing be reduced, the role of toxicologists in the interpretation of CES will need to evolve. This manuscript addresses the need for more uniform standards in conducting, reporting, and review by independent, fully focused experts if CES studies reported in the open literature will be included in the health risk characterization and litigation of chemicals.