New Toxicology Tools and the Emerging Paradigm Shift in Environmental Health Decision-Making

Area of Science:

• Toxicology and Environmental Health
• Computational Biology and Bioinformatics
• Regulatory Science

Background:

• Emerging rapid toxicity and exposure assays provide valuable data for hazard identification and decision-making in chemical regulation, product evaluation, and environmental monitoring.
• A 2018 workshop by the National Academies of Sciences, Engineering, and Medicine (NASEM) highlighted the need to balance scientific validity with societal values when implementing new toxicological methods.
• Ensuring new methods enhance public health and environmental protection requires careful consideration of their scientific validity and the values guiding their application.

Purpose of the Study:

• To explore the challenges associated with integrating new data streams into regulatory decision-making processes.
• To emphasize the importance of aligning novel toxicological methods with the specific information and confidence requirements of diverse decision contexts.
• To foster a paradigm shift towards more efficient and effective chemical safety assessments.

Main Methods:

• Building upon the NASEM workshop, this work further investigates the requirements of various decision contexts for adopting new data streams.
• Case examples from the NASEM workshop are utilized to illustrate decision contexts that can benefit from emerging toxicological data.
• The assessment synthesizes insights from the authors' experiences and the NASEM workshop's case studies and panel discussions.

Main Results:

• Shifting towards rapid, high-throughput chemical testing strategies (in vitro, in silico) necessitates careful evaluation of information needs and value considerations.
• New methods can accelerate the identification, prioritization, and management of potentially harmful chemicals.
• Successful integration requires aligning the capabilities of new methods with the specific demands of regulatory and public health decisions.

Conclusions:

• Adopting new data streams in chemical regulation requires a deliberate approach that considers both scientific rigor and societal values.
• Aligning novel toxicological methods with decision-making contexts is essential for safeguarding public health and the environment.
• This paradigm shift promises to optimize resource allocation while enhancing chemical safety and environmental protection.