O-111 Translating Observational Research into Regulatory Science: The Role of U.S. EPA’s Office of Pesticide Programs in Evaluating Epidemiologic Evidence

Abstract

<h3>Introduction</h3> The U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP) is a licensing program that regulates pesticides 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 research on the health effects of pesticides and plays a critical role in translating epidemiologic research into regulatory science and policy. <h3>Objectives</h3> OPP has developed a framework to ensure that pesticide risk assessments include systematic evaluation of epidemiologic research on the potential adverse effects of pesticide exposure. The objective of the presentation is to raise awareness about how epidemiologic research on pesticides can inform risk assessment and occupational health policy by: (1) Providing background on OPP’s risk assessment process, (2) Describing how OPP evaluates epidemiologic research using an approach that is scientifically robust and transparent; and (3) Highlighting opportunities for collaboration between researchers and risk assessors on the translation of epidemiologic research into risk assessment. <h3>Methods</h3> OPP has extensive experience evaluating epidemiology studies on pesticides and is required to review all registered pesticides according to a 15-year registration review schedule. Building off of this experience, OPP will provide a survey of its evaluation approach and explore challenges that may be promising areas for future collaboration between researchers and risk assessors. <h3>Results and Conclusions</h3> EPA/OPP routinely evaluates epidemiology research on pesticides and is guided by a systematic review framework that is scientifically robust and transparent. While epidemiologic research increasingly plays important role in the risk assessment process, there are important regulatory challenges that often limit the ability of OPP to translate research findings into policy. Therefore, there is a critical need to strengthen collaboration between researchers and risk assessors to better understand the scientific capabilities and data needs across occupational health disciplines.