How can the process of validation, acceptance and use of animal-free innovative approaches to assess the safety of chemicals be facilitated? This was the topic of the second joint workshop of the German Federal Institute for Risk Assessment (BfR) and RIVM (13th and 14th June 2018, Bilthoven). International experts from governmental institutes, regulatory agencies, industry, academia and animal welfare organisations discussed this topic in interactive sessions.
Validation is a procedure used to assess the reliability and relevance of a new test method. It is an important step towards regulatory acceptance, implementation and use of a new method for chemical safety assessment. Current validation procedures are designed for single test methods. These procedures are not fully compatible with progress made in the field of animal-free innovations, in which often information from multiple methods needs to be combined to assess the safety of a chemical.
Two scenarios can be followed towards an animal-free safety assessment framework. Firstly, an evolutionary scenario in which the current animal test-based system is modernised step by step as new animal-free approaches become available. Secondly, a revolutionary scenario that starts from scratch by describing the human biology and how this can potentially be affected by chemicals. Insight in the mechanisms involved in toxicity can subsequently be used to develop novel test methods. Ultimately, a framework combining different animal-free approaches covering human biology can be developed. The current validation procedures need to be adapted to be able to assess the reliability and relevance of such a revolutionary scenario.
Picture: Experts attending BfR and RIVM workshop
International experts exchanged their points of view on how the process of validation, acceptance and use of animal-free innovations can be facilitated along the scenarios for evolution and revolution. They discussed a human biology-driven approach for mechanistic validation. Key recommendations were the need to define the biological relevance and uncertainties of new test methods and to use these aspects to evaluate their scientific validity. The need to increase experience and confidence was recognised. This can be achieved, for example, through case studies with defined sets of chemicals in which multiple stakeholders collaboratively participate. A workshop report will be published soon.
For years, BfR and RIVM have been dedicated to replace, reduce and refine animal testing for regulatory safety assessment. The Joint Declaration of Intent between both organisations has strengthened the collaboration in this area. This and future workshops aim to bring together all stakeholders to achieve acceptance, implementation and use of animal-free methods for safety assessment.