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October 25, 2023

NanoHarmony Publishes White Paper on OECD Test Guideline Development

Lynn L. Bergeson Carla N. Hutton

NanoHarmony published on October 13, 2023, a white paper entitled From Science to Regulation: The NanoHarmony White Paper on Test Guideline Development. NanoHarmony states that the Organization for Economic Cooperation and Development’s (OECD) Test Guidelines (TG) Programme helps to develop harmonized agreed methods that can be used by OECD member countries to implement their regulatory regimes. According to NanoHarmony, for regulations to be effective and for manufacturers to be able to comply with regulatory requirements, OECD TGs need to remain up to date and fit for purpose. The white paper provides eight recommendations in four areas that are intended to help improve the effectiveness of the TG development process of moving new methods from science to regulation more efficiently:

Ensure OECD Test Guidelines Remain Up to Date

  • Establish a formal structure for stakeholder engagement to allow for continuous early identification of required new or adapted OECD TGs.
  • The European Commission (EC), European Union (EU) member states, and stakeholders should support the Malta Initiative’s European Test Methods Strategy as proposed in its position paper.

Engage the Scientific Community

  • OECD member countries should encourage universities, professional societies, industry associations, and other relevant stakeholders to include TG development in their curricula and training to help raise awareness of the role and importance they play in society.
  • Funding agencies in OECD member countries should encourage and support the scientific community to improve the FAIRness (i.e., findability, accessibility, interoperability, and reusability) of their research and data.

Validation of Methods

  • OECD and its member countries should encourage and support the validation of scientific research, e.g., by providing guidance and tools for researchers over and above that contained in OECD Guidance Document 34.
  • The National Coordinators of lead countries for a TG in development should help ensure effective and efficient communication with all relevant stakeholders during validation and ensure that discussions and decisions are captured and shared.

Funding TG Development

  • 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 prioritized and focused approach.
  • OECD member countries should encourage and (financially) support the translation of scientific progress into making TGs more effective and efficient, including addressing the 3Rs principles (i.e., replace, reduce, refine).