Development and validation of alternative approaches according to article 47 of Directive 2010/63/EU: validation at stake?

Liebsch,M.; Oelgeschlager,M.; Luch,A.

It took 15 years from the first validation concepts (Amden I) to international consensus on theOECD Guidance Document No. 34 (GD 34) on the principles and procedures of validation andacceptance of new toxicological test methods in 2005. Interestingly, during the process of harmonisationat the OECD level, finally everyone agreed that these principles and proceduresare relevant for all new methods, including new animal tests, though they were originally onlydefined to assure that the validity of new alternatives is assessed with a high level of scrutiny.GD 34 is based on real experiences with prospective and retrospective validation studies and,since reflecting fundamental principles applied in science, it is used as a comprehensive templatealso for other areas. Six years after publication of GD 34, the world has changed. TheEU REACH chemicals legislation and the 7th Amendment of the Cosmetics Directive76/768/EEC are calling for avoidance of animal testing, in the latter case even for a total ban.Moreover, publication of the concept of eTox21f by the US Research Council has led to researchfunding programmes with a drastic increase of in vitro testing intended to be used in the regulatorycontext. Finally, new toxicological concerns are calling for new tests for regulatory usethat will require validation. This pressure has speeded up formal consolidation processes formethod acceptance, both at the EU and OECD level \ shortened commenting periods andconsolidations in written procedure. However, is this only streamlining a far-too-slow process,or is the process of thoroughly evaluating the validity of new assays at stake? Our answer isgYes, scrutiny is at stakeh. For the eTox 21f approach, we do not yet have an answer as to howvalidity may be assessed in the end. For the eclassicalf approach (validation of single methods),we do have procedures that have been successfully proven to work. However, although Directive2010/63/EU on the protection of animals used for scientific procedures requests, in Article47, Commission and Member States to share the burden of validation, in EU FrameworkProgrammes, only R&D of alternatives are being funded. The 2011 call for validation laboratoriesfrom ECVAM/EURL clearly states that, apart from help in management and chemicaldistribution, not much support will be given by the European Commission. How about theMember States? In Germany, we do have five programmes for funding alternatives at the federaland local state level, and one by a foundation, all of them supporting R&D exclusively.Only the largest programme also funds assessments up to the level of prevalidation. Even ifa German laboratory applied for national funding to participate in an EU co-ordinated validationstudy, national funding procedures and timelines would not allow this technically tohappen. Shall we really leave validation up to those who might have a conflict of interest andtherefore work for free? Has the saying gHe who pays the piper calls the tuneh become lesstrue? We make a passionate plea for spending a few percent of R&D funding for well-designedand well-managed validation studies!

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Liebsch,M. / Oelgeschlager,M. / Luch,A.: Development and validation of alternative approaches according to article 47 of Directive 2010/63/EU: validation at stake?. 2012.

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