The aim of this research project is to contribute to the acceleration of the transition to animal-free safety assessment for chemicals and pharmaceuticals in the EU, including the Netherlands, and the USA. To achieve this aim, it applies a transformative governance approach. The project will contribute to solving the problem of low acceptance and implementation of animal-free safety assessment.
Transformative governance is focused on the underlying causes of societal problems, and incorporates three levels of transitions. The project operationalizes these niche, regime and landscape levels as follows. At the niche level, it develops the transdisciplinary knowledge needed to demonstrate the usability and applicability of Next Generation Risk Assessment (NGRA) for chemicals and pharmaceuticals. At the regime level, it facilitates the (regulatory) acceptance of NGRA for chemicals and pharmaceuticals, and draws broader lessons for the transition to animal-free safety assessment. The project will develop an enhanced understanding of how to govern the acceleration of this transition by experimenting with transformative governance as a consortium. At the landscape level, the project analyzes the societal underlying causes of the lack of progress, with a focus on the values, convictions and interests of different societal groups, in order to develop a values framework to inform discussions on animal-free safety assessment in the context of other societal goals.
Envisioned scientific breakthroughs include: evidence that NGRA represents a better scientific approach to safety assessment than animal studies; transdisciplinary knowledge on NGRA, including its technical aspects and consequences for governing safety assessment; transdisciplinary knowledge on governing the acceleration of the transition to animal-free safety assessment; and enhanced theoretical understanding of the concept of transformative governance.
Envisioned societal breakthroughs are: increased acceptance and implementation of NGRA, replacing animal studies; and experience with governing the acceleration of transitions, which is relevant for animal-free safety assessment and other sustainability transitions.