Next Generation Risk Assessment Framework for Nanomaterials

This article is a research paper that discusses the challenges associated with applying New Approach Methodologies (NAMs) for the safe design and regulatory risk assessment of advanced nanomaterials (AdNMs). It proposes a framework for Next Generation Risk Assessment (NGRA) that aligns with conventional risk assessment paradigms. The framework is characterized as exposure-driven and endpoint-specific, utilizing pre-existing information and allowing for a tiered approach that increases in specificity and complexity. This tiered structure aims to assess safety cost-effectively while minimizing the use of vertebrates. The paper evaluates the regulatory readiness of emerging NAMs based on criteria such as Transparency, Reliability, and Applicability, and discusses their relevance to each step of the risk assessment process. The manuscript also highlights the evolving nature of engineered nanomaterials and the need for innovative assessment methods to address the complexities and data gaps associated with these materials.