Stakeholder involvement and dissemination - results of two workshops : OSIRIS - optimized strategies for risk assessment of industrial chemicals through integration of non-test and test information

Abstract

This book describes different possibilities of stakeholder involvement in the nature science research process. It summarizes the outlines and results of two stakeholder workshops of the OSIRIS project. OSIRIS will develop integrated testing strategies (ITS) fit for REACH. These enable to significantly increase the use of non-testing information for regulatory decision making, and thus to minimise the need for animal testing. The OSIRIS project aims to replace testing methods with non-testing strategies that provide results primarily based on computer modelling and simulation with a similar degree or even higher degree of validity and reliability than the results of experimental testing procedures. Using computer models and other non-testing methods help to optimise efficiency, reduce overall costs, match the ambitious time schedule of the REACH regime and improve public acceptance due to less animal testing. OSIRIS will work with statistical models and data obtained from testing methods that promise fast, accurate and targeted information. A potential drawback of these new procedures is the possibility that unexpected outlayers remain unnoticed because computer models can only deduce inferences from existing knowledge (reducing epistemic uncertainty) and random variations (reducing aleatory uncertainty). To ensure optimal uptake of the results obtained in this project, end-users in industry and regulatory authorities (EU-stakeholders) have been invited to participate in the project, for example by becoming involved in monitoring and by providing specific technical contributions. A central component of the stakeholder involvement strategy is the organisation of four workshops along the basic research steps. The workshops will highlight the different approaches and present the results of the project to key stakeholders. In this document, the outline and results of the first two workshops are described. The first Expert Workshop took place in Stuttgart (Germany) at the Waldhotel Degerloch in November 2007 for two days. 24 scientific experts from industry, academia, and regulatory agencies attended the workshop. The first workshop aims at receiving feedback from the participants on the overall scientific approach and the main framing of the research. For this purpose, representatives of Pillar 4 coordinated by Dr. J.J.M. (Han) van de Sandt, (TNO Quality of Life in Zeist) presented their research plans and asked for feedback from experts. This consultation was organized in the form of a Group Delphi. The second workshop was designed to provide an overview of preliminary results and was scheduled for November 2008 in Brussels. The main topic of this workshop was the match between REACH requirements and the proposed methods to meet these requirements with respect to human and ecological endpoints. Major stakeholders from industry and civil society as well as a group of interdisciplinary experts from academia and government have been invited to provide valuable input to the OSIRIS team and to discuss the contributions of the OSIRIS research for the REACH characterization and risk assessment process. This paper reports the structure of the first two workshops and its results. The first chapter characterizes the Group Delphi method and describes the results of one individual and two group surveys in the context of the Group Delphi. The outcomes of the first workshop are summarized in the last section. Chapter 2 characterizes the structure of the second workshop with presenters and opponents and World Café. The outcomes are decribed in the following sections. The workshops were part of pillar 4 of the integrated EU-Project OSIRIS which is coordinated by Dr. J.J.M. (Han) van de Sandt, TNO Quality of Life, Utrechtseweg 48, 3704 HE Zeist, The Netherlands. The project is funded by the European Commission within in the 6th Framework Programme under the theme "Global Change and Ecosystems", coordinated by Prof. Dr. Gerrit Schüürmann at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig.