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Understanding the Paradigm Change at the Interface of Emerging Sources of Environmental Health Data and Decision-Making: A Workshop

Completed

Advances in the environmental health sciences – from high-throughput cell-based in vitro studies to environment-wide association studies – have led to new approaches to understanding the toxicity of chemicals in humans. These approaches are faster, less expensive, and potentially more comparable to human exposures than legacy animal toxicity testing approaches. However, many questions remain about whether and how to make the paradigm shift to using new data streams as the basis for the wide array of research, policy, and regulatory decisions.

Description

An ad hoc committee will plan and convene a public workshop to explore evidence-based approaches to increasing the understanding of environmental health community (scientists, risk assessors, policymakers, and regulators) about decisions based on data from emerging, non-animal toxicity testing approaches. The workshop will focus on research, policy, and regulatory decision contexts, such as screening and prioritizing chemicals, risk assessment, setting exposure limits, among other decisions, that are affected by 2016 Lautenberg Act amendments to the Toxic Substances control Act (TSCA) in addition to non-TSCA regulatory and policy elements. The workshop participants will discuss key areas of social science needed to help the environmental health community (across all sectors) identify and inventory concerns about and increase understanding of the 'paradigm shift' away from gold-standard/legacy in vivo animal toxicity testing approaches. Specifically, the workshop discussions will explore empirical evidence on key factors or considerations that influence investigator, policymaker, and regulator:

1. understanding of the type and quantity of data that is ‘sufficient’ for their different decision contexts; and

2. confidence in data produced by new or emerging methods to assess environmental health implications of environmental exposures (i.e. non-animal/non gold-standard approaches).

Case studies from different decision contexts may be used to elucidate what builds confidence in new scientific approaches among members of the environmental health community.

The workshop will not attempt to answer questions about how much confidence that individual toxicity testing approaches may engender. Rather, the workshop will raise awareness about the questions and trade-offs that will need to be addressed in order to facilitate a systematic use of data from new and emerging approaches to toxicity testing in a manner that maximizes confidence in those new tests and in public health protection. The workshop will build upon previous work of the Standing Committee on Emerging Science for Environmental Health Decisions, including the 2017 workshop, Advances in Causal Understanding for Human Health Risk Based Decision Making, and also draw from findings of the 2017 National Academies report, Using 21st Century Science to Improve Risk-Related Evaluations.

The workshop will result in a workshop proceedings, written by a designated rapporteur in accordance with institutional guidelines.

Contributors

Sponsors

Department of Health and Human Services

National Institute of Environmental Health Sciences

Staff

Keegan Sawyer

Lead

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