Project Coordinated By Vireo Advisors at the OECD WPMN Publishes Final Reports on Advancing Adverse Outcome Pathway Development for Nanomaterial Risk Assessment and Categorization

The outcomes from an Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) project, “Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization” (NanoAOP) have been officially published in a series of final reports. Vireo Advisors led a team of international collaborators from Canada, United States, Netherlands, United Kingdom, and Switzerland to develop resources and methodologies to contribute to the future development and application of AOPs for nanomaterial (NM) decision making. The proposed methodologies follow the principles established for AOPs by the OECD Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST). Three reports have been published which present the outcomes of the project:

1. Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization Part 1: Final Project Report and Recommendations with Methodology to Prioritize Key Events (KEs) Relevant for Manufactured Nanomaterials

The report outlines the overall scope and aims of the project, its development and summary of the main conclusions. The document also presents a developed methodology to identify, analyze and evaluate existing nanotoxicology literature to prioritize Key Events (KEs) relevant for NMs.

2. Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization Part 2: Case Study on Tissue Injury

The report presents a methodology for analyzing empirical evidence in the nanotoxicity literature to develop KEs for use in AOPs. The methodology is presented as a case study evaluating a prioritized KE for nanomaterials: tissue injury.

3. Advancing Adverse Outcome Pathway (AOP) Development for Nanomaterial Risk Assessment and Categorization Part3: Workshop Report and Recommendations

The report presents the main conclusions from an OECD workshop hosted as part of the project in collaboration with the European Union (EU) Horizon 2020 projects ‘SmartNanoTox’ and ‘Physiologically Anchored Tools for Realistic nanOmateriaL hazard aSsessment’ (PATROLS). The workshop gathered experts including regulators, policy makers, industry representatives, governmental organizations and academics to provide input on the status, use and future needs for the use of AOPs in NM risk assessment. The discussions, recommendations and conclusions from the workshop was used to outline a roadmap, broken out into short-, medium- and long-term actions, aimed at overcoming identified challenges and furthering the development, use and acceptance of the AOP framework for NM risk assessment and decision making.