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Enabling Inference-Based Decision Making in Environmental Health: Prediction vs. Observation: A Workshop

Completed

New molecular and bioinformatic approaches have advanced understanding of how molecular pathways are affected by exposure and the molecular networks involved in disease. However, these advances are often not yet deemed sufficient to establish causality for public health risk assessments; regulators still rely primarily on traditional apical endpoints, such as those endpoints observed in animal studies.

Description

An ad hoc committee will organize and convene a public workshop on how environmental health pathway-based research influences the choice of molecular or intermediate events that should serve as the basis of safety assessments and science policy decisions. The committee will explore whether molecular events of concern, such as oxidative stress, need to be tied to traditional apical endpoints that are typically used to make public policy decisions. The workshop will also explore the role of dose in predictive thinking and empirical observation in animal studies. Potential workshop discussions may also include:
1) How different fields of study (e.g., laboratory studies, clinical research, and epidemiology) determine causality and their relevance to environmental health and mechanistic toxicology.
2) Frameworks to combine toxicological and epidemiological evidence to establish causal inferences; and
3) Validation and use of Adverse Outcome Pathways to enable inference-based decision making in environmental health
A brief summary of the presentations and discussions at the workshop will be prepared by designated rapporteurs in accordance with institutional guidelines.

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