81 Traac Framework and tool for Regulatory Acceptance and Wider Usability of Tools/Methods for safe Innovation and Sustainability of Nanomaterials

Abstract There has been an increasing use of manufactured nanomaterials in industrial applications and consumer products. It has instigated concerns about the sustainability, risks and uncertainties regarding the interactions of the nanomaterials with humans and the environment. Consequently, significant resources in Europe have been invested into tool and method development to support risk mitigation and management, facilitating the research and innovation process of manufactured nanomaterials. Extended risk analysis, including socio-economic impact and sustainability assessment is moving the conventional risk-based approach towards a wider safety-and-sustainability-by-design perspective. Despite growing tool and method developments, the level of awareness and use by stakeholders is still limited. Regulatory compliance and acceptance, reliability and trust, user-friendliness and compatibility with the users’ needs are important factors traditionally known to hinder their widespread use. Therefore, a framework is presented to quantify the readiness of different tools and methods towards their wider regulatory acceptance and downstream use by different stakeholders. The framework, developed within Gov4Nano, diagnoses barriers which hinder regulatory acceptance and wider usability of a tool/method based on their Transparency, Reliability, Accessibility, Applicability and Completeness (TRAAC framework). An online TRAAC tool is being developed within HARMLESS that will be freely available on https://diamonds.tno.nl/#traac. Fourteen tools and methods were assessed using the TRAAC framework as proof-of-concept. The results provide insights into any gaps, opportunities, and challenges in the context of each of the 5 pillars of the TRAAC framework.