Food for thought... on the real success of 3R approaches.

Can the value of a scientific discipline be gauged? Where does the discipline stand? Is such a consideration important at all? Some may have doubts about the usefulness of asking such questions. Some will see the research into alternative methods as a categorical imperative. Others again will have a more differentiated view, a group that will comprise policy makers, those that provide funding and infrastructure for research, those that are responsible for our safety and that of our environment, and, last but not least, those that are about to choose their future field of scientific work. All these person groups will at some point use cost-benefit considerations and value balances. This type of thinking also applies largely to the general population of tax payers and voters. For this reason, some thoughts on the real value of 3R approaches (replace, reduce, refine, as defined by Russell and Burch, 1959, and the declaration of Bologna, 1999 (3R, 2004)) appear to be justified and necessary. On a qualitative level, the value of alternative methods is underscored by the fact that the EU funds an entire research institution (ECVAM) dedicated solely to the evaluation of alternative methods, and that major new EU legislation, such as REACH, has a strong focus on the use of alternative methods (REACH, 2006). Moreover, industry and the European Commission work together in a partnership for alternative approaches (EPAA, 2007), and universities are starting to establish departments dedicated to 3R research (Leist, 2006; Wendel, 2002). More quantitative approaches to describe the success of the new field make use of the statistics of animal use in the EU or its individual member states, or they count the number of OECD test guidelines that rely on alternative assays for safety evaluations. On this basis, progress of 3R is sometimes described as being relatively slow. In our opinion, such strategies to gauge the success of alternative approaches largely underestimate the real success of this emerging research field. Therefore, we will highlight in the following a number of conceptual errors that contribute to the underestimation of the value of 3R, and that are frequently encountered in public discussions.