A public-private platform for the pre-validation of endocrine disruptors characterization methods
Résumé
In France, a « National Strategy on Endocrine Disruptors » has been designed. A Public Private Partnership for a pre-validation platform is under study. The impetus for such an initiative is the lack of well recognized test and non-test methods for the assessment of endocrine disrupting properties. Irrespective of what might be the regulatory definition of an “endocrine disruptor”, tools must be made available. Such tools are also needed for achieving consensus in non-regulatory discussions and in screening. Although such methods exist in some specific domains (estrogenic and androgenic activity, thyroid activity…), there is both a lack of methods and a lack in the recognition. The public private partnership project aims to fill the gap between the development and the availability of internationally validated – or at least well recognized - methods. Basically, the purpose of the platform is to fund the operational aspect of the validation process. Indeed, the operational phase of the validation process (e.g. relevance, repeatability, reproducibility) is not attractive for academic teams. It is not rewarding for private CRO, and it does not provide a monetary pay-back to test developers. Moreover there is no proper funding at European or international levels. As a result, the international process is slow, and supports are required to enhance it. In addition to the experimental aspect, two expertise processes are integrated into the platform: (1) Evaluation of the relevance of the proposed methods compared to those already available on the market in order to select those that deserve to be tested (upstream); (2) Decision on the success of the process for a method to qualify it or not (downstream). It is therefore important for all stakeholders to have good knowledges and interactions with this platform. It is also significant to notice that the platform interacts with a network of international scientists who will check the legitimacy of the work carried out. To achieve these objectives, the platform proposes a new type of governance expected to enhance the dialogue between stakeholders (public and private bodies, NGOs, researchers…). If the French ambition to develop a strategy on endocrine disruptors relies on the availability of a platform devoted to this task, of course this initiative must be consistent with the international approaches (OECD, ISO, ECVAM in the case on alternative methods). It must not be an isolated initiative. With the support of international and national public institutions and the industry, a project was presented for co-funding at the call “Investment for the Future” operated by the national bank for innovation in June 2018. The process is still going on. INERIS has coordinated the proposal in the name of a comity constituted with the support of the Ministry of Ecology and including industrials (France Chimie, FEBEA, Bayer-France and Basf-France, etc.) and CROs. If successful, the structure would be an independent stateapproved association. Whatever the result for the project itself, ISTA is the good place to discuss about the idea of setting up such a platform.