White Paper
NanoHarmony project published a White Paper on OECD Test Guideline development From Science to Regulation. International agreement on methodologies to test and characterise chemicals and advanced (nano)materials is essential to protect human health and the environment. The OECD Test Guidelines Programme helps to develop harmonised agreed methods that can be used by OECD countries to implement their relevant regulatory regimes, ensuring that chemicals and advanced (nano)materials are safe and sustainable.
However, for regulations to be effective and for manufacturers to be able to comply with regulatory requirements, the OECD Test Guidelines (TGs) need to remain up to date and fit for purpose. Using feedback from relevant stakeholders, NanoHarmony makes eight recommendations in four key areas to help improve the effectiveness of the TG development process of moving new methods from science to regulation more efficiently.
Dr. Eric Bleeker, Risk Evaluator at The National Institute for Public Health and the Environment (RIVM, Netherlands) and lead author of the NanoHarmony White Paper says, “During NanoHarmony, it became more than evident that the Test Guideline development process needs to be more effective. Over the last few years there has been great advances in the science, including developments in new and needed test methods usable for regulatory testing. But the movement of these developments through the process to become OECD Test Guidelines can be more efficient.”
Recommendations in the White Paper include:
- A formal structure for stakeholder engagement should be established to allow a continuous early identification of required new or adapted OECD Test Guidelines.
- OECD Member Countries should encourage universities, professional societies, industry sector bodies and other relevant stakeholders to include Test Guideline development in their curricula and training to help raise awareness of the role and importance they play in society.
- OECD Member Countries should provide long-term, dedicated additional funding to help ensure that TGs are kept up-to-date and relevant to regulatory requirements, especially for new chemicals and materials, ensuring a prioritised and focussed approach.
All of the recommendations were recently discussed during a NanoHarmony policy meeting with relevant stakeholders including representatives of OECD, regulation and industry who agreed on the importance of their implementation. Anne Gourmelon, of the OECD Test Guidelines Programme welcomes the recommendations of the NanoHarmony White Paper: “They will be discussed with Member Countries and are an important contribution to our work in helping countries to better evaluate safety and regulate new chemicals and advanced materials.”
Dr Karin Wiench, Director, GB Product Stewardship at BASF and Chair of the Business at OECD (BIAC) Delegation to the Working Party on Manufactured Nanomaterials (WPMN) at the OECD, says “Industry benefits from the OECD Test Guidelines Programme as it allows us to bring new products to the market faster whilst complying with regulatory safety requirements. Implementing the recommendations of the NanoHarmony White Paper will help make the Test Guideline development process more efficient. This facilitates us to bring safe innovations more promptly to the market for the benefit of citizens.”
Whilst the funding for the NanoHarmony project has now ended, implementing the recommendations in the NanoHarmony White Paper will ensure more efficiency in developing new OECD Test Guidelines and allow regulations to keep pace with scientific innovations in the field of test developments and industrial innovation in new materials.
Process Mentor
The NanoHarmony OECD TG/GD Process Mentor (www.testguideline-development.org) is an interactive web-based tool to guide stakeholders through the development process of OECD Test Guidelines (TGs) and Guidance Documents (GDs). The OECD publishes internationally agreed and accepted standard methods for the safety testing of chemicals and nanomaterials. Under the OECD Mutual Acceptance of Data (MAD) system, laboratory tests performed under an accepted TG and following Good Laboratory Practises (GLP), can be accepted in all OECD Member countries and countries adhering to MAD for the purposes of safety assessment.
The NanoHarmony OECD TG/GD Process Mentor has been developed to highlight the involvement of key institutions in the OECD Test Guidelines Programme, and their incentives to take part in the TG development. It brings guidance and tips on how to develop or adapt TGs and GDs, including when and how to prepare for required activities, key start and finish dates of the development process, and who to involve in which activities and when.
As an online guidance tool, the NanoHarmony Process Mentor is for anyone with an interest in the OECD TG development process, including those interested in leading or participating in a TG development. It can be used by research projects who need to understand how their new methods can be taken into the OECD process, by university teachers who can educate their students on how science is used in regulations or by governments to train the next generation of regulatory scientists. For this purpose, the Process Mentor also hosts the NanoHarmony training material (https://www.testguideline-development.org/useful-resources#Introduction-OECD-standardisation) that was also developed as part of the project. The NanoHarmony training material provides a low-level entry into the topic of standards and harmonised OECD Test Guidelines and how science can contribute to this.
“The NanoHarmony OECD TG/GD Process Mentor will help people understand the OECD TG Development Process better and acts as a useful tool to steer people through this complex process. It makes TG developments easier, allows developers to understand the whole process and what steps they need to take at each phase.” says Dr Elise Morel from the UK Centre for Ecology & Hydrology (UKCEH) and the main editor for the Process Mentor
Mar Gonzalez from the OECD is enthusiastic about the tool and states, “The Process Mentor will be an excellent tool to complement our existing guidance on developing TGs by compiling practical advice for us to share with the whole OECD TG/GD development community. It will support our work and gives everyone a hands-on and intuitive tool. It is an easy and straight forward way to get to understand the process as well as to help those who actively try to move a new method from science to standardisation & harmonisation.”
Professor Eva Valsami-Jones, Coordinator of the EU Nanosafety Cluster, sees the big advantage of bringing scientist closer to societal needs and how their work can contribute to a safer Europe “The NanoHarmony OECD TG/GD Process Mentor is a much-needed tool to help scientists developing innovations that will be the basis for future harmonised test methods. The Nanosafety Cluster, which represents European funded projects addressing the safety of materials, believes that this tool will help the projects understand how to move their science into regulatory useful methods and will also be useful to help train the future generation of scientists.”
The NanoHarmony Process mentor can be accessed for free at (www.testguideline-development.org) by anyone with an interest in OECD Test Guidelines.