Translating Observational Research into Regulatory Science: The Role of U.S. EPA's Office of Pesticide Programs in Evaluating Epidemiologic Evidence

Abstract

The U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP) is a licensing program that regulates pesticides in the U.S under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). As part of this program, OPP has a regulatory mandate to evaluate a substantial body of health effect and exposure data in order to assess the effects of pesticides on human health. Through this evaluation, OPP plays a critical role in translating observational research into regulatory science and aims to ensure that pesticide risk assessments incorporate epidemiologic evidence on the potential adverse effects on people that may result from pesticide exposure through dietary, environmental, and occupational exposure pathways. The thematic poster will provide background on OPP’s regulatory requirements and then describe the systematic review methodology used to evaluate epidemiologic evidence based on a scientifically robust and transparent approach. This description will emphasize key regulatory considerations and outline elements of OPP’s 2016 framework for incorporating epidemiological data into risk assessments for pesticides. The 2016 framework may be of interest to a range of stakeholders in the scientific community and characterizes OPP’s “fit-for-purpose” approach to systematic review. OPP uses this approach to define to the scope and complexity of reviews and integrate epidemiologic findings into OPP’s overall risk assessment process.