New Approach Methodologies in Regulatory Toxicology

The field of regulatory toxicology is evolving rapidly and is crucial for ensuring public health and environmental safety by evaluating the potential hazards and risks posed by chemicals and products. Recently, New Approach Methodologies (NAMs) have gained traction as innovative tools that hold considerable promise to modernize safety evaluations by reducing, replacing or refining traditional laboratory animal toxicity tests. NAMs, which include computational models, in vitro techniques, and alternative biological systems, can significantly reduce reliance on animal testing while potentially providing faster and more predictive results. However, integrating these novel methods into regulatory frameworks poses unique challenges and uncertainties. While promising results have emerged, uptake and use in regulatory contexts remains limited, prompting the need for systematic approaches for evaluating and documenting scientific confidence in NAMs to support regulatory and product stewardship decisions.



This Research Topic aims to explore and expand the understanding and application of New Approach Methodologies (NAMs) within the scope of regulatory toxicology. The objective is to assess their efficacy and reliability in regulatory settings, understand the challenges associated with their adoption, and identify opportunities for their practical applications. The goal is to provide a platform for rigorous scientific discussions that could help bridge the gap between innovative methodologies and regulatory acceptance and implementation. This effort encompasses evaluating NAMs' potential to enhance hazard evaluations, accelerate risk assessments, ensure product safety, and advance public health protection.

To gather further insights in the practical applications of NAMs in regulatory frameworks, we welcome articles addressing, but not limited to, the following themes:

• Case studies highlighting the use of NAMs in regulatory settings and decision making

• Case studies using NAMs for product stewardship

• Systematic frameworks for establishing scientific confidence in NAMs to support specific regulatory decisions

• Converting NAM-derived effect concentrations to equivalent exposures in human and ecological receptors (IVIVE, HTTK)

• Use of NAMs to evaluate complex substances (UVCBs, Multi-Constituent Substances)

• Examples of NAMs profiling for biomarkers of effects to support regulatory decisions.

• Using NAM-based assessments to evaluate occupational hazards, exposures and risks

• Innovations in human health risk assessment via NAMs

• The use of NAMs to predict human and/or environmental exposures

• Integrated tiered testing and assessment approaches using NAM-based frameworks



By delving into these areas, we aim to foster a deeper understanding of how NAMs can be effectively integrated into the regulatory toxicology landscape to benefit regulatory agencies, industry stakeholders, and public health.