Data quality evaluation criteria for systematic review of epidemiology studies under the Toxic Substances Control Act (TSCA): refinement through practical application in risk evaluation

Abstract

BACKGROUND AND AIM: The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act and the 2017 Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) to conduct risk evaluations using the best available science and weight of the scientific evidence. Therefore, EPA has developed systematic review methods including data quality evaluation criteria to evaluate scientific studies in specific disciplines including epidemiology. EPA has aimed to refine these criteria for practical application in risk evaluation of high-priority chemicals under TSCA. METHODS: EPA considered the pros and cons of multiple existing systematic review frameworks and guidance documents and drew upon these methodologies to develop data quality evaluation domains, metrics, and criteria for the systematic review of epidemiology studies under TSCA. EPA refined these domains, metrics, and criteria through practical application to add specificity to increase consistency among evaluators and to harmonize with the evaluation of animal toxicology studies under TSCA. RESULTS: EPA adopted aspects of methods including the National Toxicology Program (NTP) Office of Health Assessment and Translation (OHAT) and EPA’s Integrated Risk Information System (IRIS) methods, but also aimed to be consistent with other disciplines and to address TSCA scientific standards. CONCLUSIONS: EPA has further refined data quality evaluation criteria for systematic review of epidemiology studies under TSCA in response to comments from peer reviewers, the public, the National Academies, and the TSCA Science Advisory Committee on Chemicals (SACC). Systematic review of epidemiology studies is a critical component of protecting human health under TSCA. DISCLAIMER: The views expressed in this presentation are solely those of the authors and do not represent the policies of EPA. Mention of trade names or commercial products should not be interpreted as an endorsement by EPA. KEY WORDS: Systematic Review, Data Quality Evaluation