A high-level overview of the OECD AOP Development Programme

Background The Organisation for Economic Co-operation and Development (OECD), through its Chemical Safety Programme, is delegated to ensure the safety of humans and wildlife from harmful toxicants. To support these needs, initiatives to increase the efficiency of hazard identification and risk management are under way. Amongst these, the adverse outcome pathway (AOP) approach integrates information on biological knowledge and test methodologies (both established and new) to support regulatory decision making. AOPs collate biological knowledge from different sources, assess lines of evidence through considerations of causality, and undergo rigorous peer-review before being subsequently endorsed by the OECD. It is envisioned that the OECD AOP Development Programme will transform the toxicity testing paradigm by leveraging the strengths of mechanistic and modeling based approaches and enhance the utility of high throughput screening assays. Since its launch, in 2012, the AOP Development Programme has matured with a greater number of AOPs endorsed, and the attraction of new scientific disciplines (e.g. the radiation field). Recently, a radiation and chemical (Rad/Chem) AOP Joint Topical Group has been formed by the OECD Nuclear Energy Agency High-level Group on Low-dose Research (HLG-LDR) under the auspices of the Committee on Radiological Protection and Public Health (CRPPH). The topical group will work to evolve the development and use of the AOP framework in radiation research and regulation. As part of these efforts, the group will bring awareness and understanding on the program, as it has matured from the chemical perspective. In this context, this paper provides the radiation community with a high-level overview of the OECD AOP Development Programme, including examples of application using knowledge gleaned from the field of chemical toxicology, and their work toward regulatory implementation. Conclusion Although the drivers for developing AOPs in chemical sector differ from that of the radiation field, the principles and transparency of the approach can benefit both scientific disciplines. By providing perspectives and an understanding of the evolution of the OECD AOP Development Programme including case examples and work toward quantitative AOP development, it may motivate the expansion and implementation of AOPs in the radiation field.

Automated summary

This paper provides an overview of the OECD AOP Development Programme, including its application in the field of chemical toxicology and its work towards regulatory implementation. While the drivers for developing AOPs differ between the chemical and radiation fields, the principles of the approach can benefit both scientific disciplines.