Standardised and harmonised test methods that are up to date are needed for regulation to be effective and keep pace with innovation. They are key tools for gaining information on the characteristics and hazards of chemicals. Test Guidelines (TGs) published by the Organisation for Economic Cooperation and Development (OECD) are agreed upon by the OECD Member countries and data generated using TGs are accepted by these countries through the Mutual Acceptance of Data (MAD). This lowers the barriers to trade worldwide. TGs also contribute to the reduction of animal testing and help reduce the costs of regulatory compliance. With the developments of nanomaterials and advanced materials, OECD TGs and guidance documents (GDs) need to be updated or newly developed for substance safety assessments.
The NanoHarmony project (EU Horizon 2020, grant agreement No 885931) supported the development of scientifically sound and reliable test methods and good practice documents for physicochemical characterization and testing of nanomaterials, based on the translation of existing scientific knowledge and data into a regulatory relevant form. Involvement of a large number of stakeholders in the OECD TG development was key to NanoHarmony and successfully facilitated through open workshops, interviews and webinars. All these NanoHarmony activities were closely connected with the OECD Test Guidelines Programme and linked to the Malta Initiative.
Identified methodological gaps and process-related obstacles were used to create several legacy items for the NanoHarmony project to further streamline the future development of regulatory-relevant test methods that keep pace with new developments in materials and methods. One of these legacy items is the NanoHarmony OECD TG/GD Process Mentor. This web-based tool has been created to help the future developers of OECD TGs/GDs to bring their science forward as harmonised test methods. It brings together an understanding of how to move through the OECD institutional TG/GD development/revision process, when to start and finish each phase of activities based on the annual OECD cut-off dates and who to involve in these activities. It also compiles access to relevant resources (e.g. NanoHarmony training materials, OECD resources) for different stakeholders engaging with an OECD TG/GD project.
The NanoHarmony OECD TG/GD Process Mentor tool highlights the interests and opportunities for the scientific community (and other stakeholders involved) to become more engaged in developing useful information based on the regulatory requirements and needs.
It is important for people interested in developing future OECD Test Guidelines (TGs) to understand the various key institutions that play a role at different phases of OECD TG development and to appreciate that early engagement with some institutions can help in later phases. For example, engaging small and medium enterprises, contract and research organisations and consultants at earlier phases could help to ensure that the eventual TGs are practical, cost-effective and useful for regulatory compliance in the industry (i.e. TG actual purpose). Indeed, TG developers will often not steer multiple TGs through to eventual acceptance and publication, so it is useful for those thinking of working on an updated or new TG to understand the role that different institutions play to help them develop their background knowledge of the process and to benefit from the shared knowledge in this tool.
It is also important to understand the reason why individual institutions are interested in the work of developing OECD TGs as this knowledge is useful to future TG developers to help them be more efficient in steering their TG through the process. For example, drawing in experts from a wide range of stakeholder groups and key institutions will help deliver better outcomes for new TGs being proposed or TGs to be adapted. Ensuring that different viewpoints and perspectives are represented will help ensure the robustness and effectiveness of the eventual TG.
Increasing the engagement of stakeholders in TG development is generally a positive step and adds value to the overall process, while the institutional landscape around TGs can be confusing for those who do not have the experience of working within it. For example, some institutions have a role during each phase such as the OECD Working Group of National Coordinators of the TGs programme (WNT), others may only be active in one phase. An important effort has been put in the NanoHarmony OECD TG/GD Process Mentor to describe the roles and incentives of the key institutions involved in the OECD Test Guidelines Programme. You are also invited to watch the recording of the roundtable on stakeholder involvement in the OECD TGs Programme with representants of the OECD secretariat (Chair Thomas Kuhlbusch (BAuA), Mar Gonzalez (OECD secretariat to WPMN), Anne Gourmelon (OECD secretariat to WNT), Tim Singer (Canadian National coordinator to WNT), Susanne Wlatyer-Rohde (German National coordinator), Michael Oelgeschlager (Chair WNT)).
Roundtable: OECD Test Guidelines and Stakeholder Involvement
Despite the substantial efforts and progress of the scientific community to develop knowledge and techniques to assess the exposure and health and safety aspects of chemicals and materials, very little of this information has yet translated into OECD test guidelines (TGs) or guidance documents (GDs) making it usable for evidence provision in a regulatory context.
Several NanoHarmony activities were deemed to identify barriers in translating science to regulation. You can for example watch the recording of the webinar entitled; ‘NanoHarmony: Identification and solving barriers for translating science to regulation’. A significant portion of the scientific knowledge is simply not acceptable for that purpose, because it does not meet the strict quality criteria that justifies the need for the development or adaptation of a TG or GD. This is in part because often scientific researchers are not aware of the requirements for their outputs to become successful in the OECD processes, or they are not even aware that their information can have an added value in this context. Another issue is that new relevant scientific knowledge does not always reach regulatory bodies, except through the published literature. The formal processes by which OECD TGs or GDs are developed and approved are generally very time and labour-consuming and complex. Combined with this is the added hurdle for academic researchers to consider to what extent this effort will be beneficial for their CV and promotion prospects.
To help TG developers approach the OECD development process for the first time the NanoHarmony OECD TG/GD Process Mentor provides guidance for navigating across various barriers of the process. It includes a description of each phase of the OECD TG/GD development/revision process and details tips, tricks and timelines for each of them. It should be noted here that the process needs caution to ensure useful test guidelines and not all steps in the process can be sped up to the same extent.
NanoHarmony: Identification and solving barriers for translating science to regulation