Epidemiology for risk assessment: The US Environmental Protection Agency quality considerations and the Matrix

Epidemiology research plays an important role in regulatory risk assessments. However, regulatory approaches to evaluating study utility and quality for risk assessment purposes can vary, even within a single agency. The goal of the current review is to compare different guidelines within the US Environmental Protection Agency (US EPA) for evaluating epidemiology research with respect to quality. This review highlights the elements of epidemiology design and reporting that are most useful for risk assessment and regulatory decision making. General guidance documents from the US EPA that assess pesticides (Office of Pesticide Programs Framework), air pollutants (Integrated Science Assessment Preamble), and environmental chemicals (Integrated Risk Information System Handbook) were included. Chemical-specific examples of the use of these guidance documents were selected to provide additional information on each methodology. All three evaluation approaches require professional judgment, and none include a quantitative scoring approach. All indicate numerous aspects that enhance the value of a study for risk assessment. However, the methods and the level of detail vary. More clarity within US EPA documents would aid researchers. The elements of the Matrix tool, designed to facilitate translation of epidemiology studies to risk assessment, build on the US EPA epidemiology guidelines and may further enhance the value of such studies.