The OECD does not decide on the different regulatory requirements that different countries have. Still, OECD assists countries in developing tools that are of common agreements that can help to implement regulation within the countries members of OECD. Thus, besides the maturity of the scientific basis of the test method, the international regulatory need and the rationale for the selection of this test method or testing strategy need to be clearly defined and outlined for the acceptance of the project within the OECD Test Guidelines Programme (TGP).
To this regard, in addition to the Solna Principles (see Maturity of the science process), the OECD GD 34 (2005) on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment lists the following criteria as important for the regulatory acceptance of a test method or testing approach:
1) Application of the method provides data that adequately predicts the end-point of interest in that it demonstrates either a linkage between (i) the new test and an existing test method or (ii) the new test and its effects on the target species.
2) The method generates data for risk assessment purposes that are at least as useful as, and preferably better than, those obtained using existing methods. This will give a comparable or better level of protection for human health or the environment.
3) There are adequate testing data for chemicals and products representative of the type of chemicals administered by the regulatory programme or agency (e.g., pesticides, cosmetics).
4) The test should be robust transferable and adequate for standardisation and harmonisation. If highly specialised equipment, materials or expertise are required, efforts should be sought to facilitate the transferability and transparency of the test method. The use and access of new test methods containing Intellectual property rights (IPRs) in a Test Guideline (TG) imply the creation of Material transfer agreements and licences and a Fair, Reasonable And Non-Discriminatory (FRAND) declaration from the owner of protected elements at the proposal stage of a TG (See Project definition at OECD, draft SPSF and OECD GD298, 2019). This is thus an important criterion to be considered at an early stage of a project proposal.
5) The test is cost-effective and likely to be used.
6) Justification (scientific, ethical, economic) should be provided for the new method with respect to any existing methods available. In this respect, due consideration should be given to animal welfare consideration, including the 3Rs.
In summary, the development of OECD Test Guidelines (TG) should always respond to an international regulatory need. The proposed methodology should be relevant, robust and reliable for governments to base their decisions on this method, i.e. regulatory acceptance is dependent upon the validation outcome. In addition, animal welfare and economic implications of the test should be considered while the test method or the testing strategy should be as broadly accessible as possible.
Preferably regulatory needs should be combined over different regulatory areas (e.g. food, medicine, cosmetics, chemicals), as the different regulations often have similar requirements with a similar need for method development. This clearly requires collaboration between the different regulatory areas, preferably on a global level.
Initial ideas for testing and assessing chemicals require exchanges between policymakers, regulators, and scientists with other relevant stakeholders (from industry and standardisation bodies, notably). For example, scientists willing to lead a project proposal at OECD may need to reach out to regulators, besides their National Coordinator (NC) at the OECD Test Guidelines Programme (TGP), to seek advice on the adequation of their proposed method in generating useful data for a particular regulatory purpose (See Pre-OECD phase). Furthermore, regulators need to communicate where they have difficulties in receiving acceptable information for specific endpoints or materials by existing (test) methods. Industry could address issues and needs towards fulfilling the regulatory requirements and could state whether test methods are missing or need to be updated.
The organisation of special events such as the regulatory risk summits recently organised by EU research projects, Gov4Nano or MACRAME, should facilitate these exchanges and complement workshops or Expert Group meetings related to Chemicals safety and biosafety activities run at the OECD. Conversations between stakeholders of the TG development process at OECD may also happen at conferences or webinars where policymakers or regulators may identify a new testing option that could meet their needs for example.
One must aim for a test that is as easy to perform as possible, while still delivering sound and useful results for international regulations.
You should be prepared to describe the (international) regulatory relevance of your project proposal, define the endpoint and use targeted by the test method or testing strategy; What is the question answered by the test method and what regulatory needs does it relate to? Why is there a new TG/GD needed or what is the improvement compared to existing TGs/GDs?
Be aware of the fact that there might be other standardisation bodies (e.g. ISO, CEN) that are already working on a standard towards the targeted regulatory endpoint. If so, cooperation and exchange with their project is recommended to align methods as far as reasonable. Make your approach known to international stakeholders; Exchange of information with the maximum of scientists, regulators, and industrials, but also with other stakeholders that can provide different perspectives, identify ambiguities, contradictions and missing aspects (e.g., Testing facilities can identify a need for developing or updating a TG). Organize workshops for alignment and communication.
Get to understand what are the various institutions that play a role at different phases of the OECD TG development process. What are the reasons why such institutions are interested in the work of developing OECD TGs? This will help you to find the most appropriate way to engage with international stakeholders from different institutional backgrounds, especially during the project ideation, when you may need support to clarify international regulatory needs.
Include regulators in your (Ad Hoc) Expert Group to ensure that the regulatory needs are adequately covered during the development process at OECD and to be aware of changing regulatory requirements. Changes in the regulatory needs for a test method may result in objections from particular OECD Member countries that previously supported the project at a later development stage, for example.
The regulatory need and the rationale for a new or an adapted OECD document need to be clarified at the beginning of the Pre-OECD phase in order to start the work towards the Project definition phase at OECD.