[Replacement of dogs as research animals for the approval testing of plant protection products].

The replacement of animal testing using dogs for the registration of plant protection products requires a long-term step-by-step procedure. The first goal should be to achieve international agreement on using only one single study in dogs. This would result in a significant short-term reduction of the use of dogs for this purpose. The competent working groups both in the EU and the United States EPA have declared this to be their intended aim. In this context, the 90-day study is to be the preferred study from the scientific as well as the animal welfare points of view. It is proposed to set up an international expert task force within the next 12 months, which should seek to initiate a process of international harmonization of the testing requirements following the example of the International Conference of Harmonization of Technical Requirements for Medical Products, ICH. The goal should be to achieve international agreement on only one single study with dogs within the next 2 to 3 years. In addition, other valid scientific procedures, with which the use of dogs for testing can be reduced, should be critically assessed. A complete replacement of the use of dogs for plant protection product testing is suggested to take place at a later stage. This may be achieved by either deriving safety threshold values by applying a safety factor to chronic NOAEL values obtained in studies using rats for those groups of substances, for which there is evidence that the dog is the more sensitive species, or by combining the chronic rat study with other animal tests stipulated for the registration of pesticides.