Report on the European Partnership for Alternative Approaches to Animal Testing (EPAA) "New Approach Methodologies...

Area of Science:

• Toxicology and Chemical Safety
• Regulatory Science
• In vitro and In silico Methods

Background:

• The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop on New Approach Methodologies (NAMs).
• Focus was on the regulatory application of NAMs for chemical safety assessment, specifically within Next Generation Risk Assessment (NGRA).
• Previous EPAA Skin Sensitisation User Forums and European Commission's Scientific Committee on Consumer Safety (SCCS) findings informed the discussions.

Purpose of the Study:

• To gain insights into the regulatory use of NAMs for chemical safety assessment.
• To compile learnings and experiences from stakeholders regarding NAM implementation.
• To develop recommendations for the integration of NAMs into NGRA.

Main Methods:

• Presentations summarizing learnings from previous EPAA Skin Sensitisation User Forums and SCCS.
• Summary of findings from five case studies illustrating NAM application.
• Discussions among stakeholders to compile insights on NAM usage.

Main Results:

• Identified key areas for NAMs in NGRA: exposure assessment, hazard identification, tiered testing, and risk assessment using NAM data.
• Highlighted the practical implementation of NAMs, including the use of -omics technologies.
• Emphasized the need for capacity building and training for effective NAM utilization.

Conclusions:

• The EPAA User Forum served as a platform for sharing safety assessor experiences with NAMs.
• Recommendations were formulated for the regulatory application of NAMs within NGRA frameworks.
• Future EPAA User Forum formats and topics were suggested based on workshop outcomes.