Evaluation of the causal framework used for setting national ambient air quality standards

Abstract A scientifically sound assessment of the potential hazards associated with a substance requires a systematic, objective and transparent evaluation of the weight of evidence (WoE) for causality of health effects. We critically evaluated the current WoE framework for causal determination used in the United States Environmental Protection Agency's (EPA's) assessments of the scientific data on air pollutants for the National Ambient Air Quality Standards (NAAQS) review process, including its methods for literature searches; study selection, evaluation and integration; and causal judgments. The causal framework used in recent NAAQS evaluations has many valuable features, but it could be more explicit in some cases, and some features are missing that should be included in every WoE evaluation. Because of this, it has not always been applied consistently in evaluations of causality, leading to conclusions that are not always supported by the overall WoE, as we demonstrate using EPA's ozone Integrated Science Assessment as a case study. We propose additions to the NAAQS causal framework based on best practices gleaned from a previously conducted survey of available WoE frameworks. A revision of the NAAQS causal framework so that it more closely aligns with these best practices and the full and consistent application of the framework will improve future assessments of the potential health effects of criteria air pollutants by making the assessments more thorough, transparent, and scientifically sound.