Ranking of human risk assessment models for manufactured nanomaterials along the Cooper stage-gate innovation funnel using stakeholder criteria

Toward Rigorous Materials Production: New Approach Methodologies Have Extensive Potential to Improve Current Safety Assessment Practices

“…The overall scheme incorporates the complete evaluation results of NAMs and HRA tools related to the many dimensions of generating a well‐functioning safer‐by‐design innovation flow. The scheme positions initially HRA tools as they are seen to be mostly useful during innovation stages . It includes further the eight NAM categories structured along the innovation stages with additionally an aligned NAM tool package with method details.…”

“…A novel safety‐testing enriched variant of Cooper Stage‐Gate innovation funnel is aligned with human risk assessment (HRA) tools and New Approach Methodologies (NAMs). The HRA tools are positioned at the top of the figure according to their applicability in the innovation funnel . The NAM categories are thereafter positioned according to their suggested applicability for implementation in HRA tools and along the innovation funnel (bottom).…”

“…The evaluation of the NAMs was based on two types of criteria. The first set used articulated stakeholder needs coupled to HRA tools positioning in the innovation funnel, including the NanoSafer Control Banding (CB) tool,10a the Life Cycle Assessment and Risk Assessment (LICARA) NanoSCAN tool, Stoffenmanager Nano, the GUIDEnano tool, and RiskofDerm 2c,11,20. The stakeholder input considered: i) availability of nanomaterial characterization, exposure, and hazard data; ii) availability of expertise and need of training/guidance; iii) quality assessment methods for data from novel nonestablished testing assays; iv) interpretation of assay data indirectly indicative of potential toxicity, e.g., biological reactivity assays data from corresponding non‐nano bulk material; v) inclusion of so far not considered endpoints in the tools, e.g., biocompatibility, cytotoxicity, oxidative stress, genotoxicity, and immunotoxicity data, as well as population level data (e.g., from workers, consumers, children, pregnant women, elderly, etc.…”

“…The stakeholder input considered: i) availability of nanomaterial characterization, exposure, and hazard data; ii) availability of expertise and need of training/guidance; iii) quality assessment methods for data from novel nonestablished testing assays; iv) interpretation of assay data indirectly indicative of potential toxicity, e.g., biological reactivity assays data from corresponding non‐nano bulk material; v) inclusion of so far not considered endpoints in the tools, e.g., biocompatibility, cytotoxicity, oxidative stress, genotoxicity, and immunotoxicity data, as well as population level data (e.g., from workers, consumers, children, pregnant women, elderly, etc. ); vi) uncertainty characterization (mostly qualitative aspects at early stages and quantitative aspects at later stages of the innovation funnel); and finally, vii) output specificity of the tools …”

“…Risk assessment of nanomaterials under a situation on limited safety information and unclear regulatory demands has included development of risk categorization, prioritization, and control‐banding tools for management and decision making . Key tasks of the European Horizon 2020 project caLIBRAte (https://www.nanocalibrate.eu) have been to collect and address stakeholder needs related to the application of such human risk assessment (HRA) tools for ensuring safety of nanomaterials . Typical reports of industry, academy, insurance companies, and regulators include the observation of absence of reliable data, lack of means for assuring data quality, need for expert assistance to interpret and utilize diverse types of safety data, lack of uncertainty estimation generally in studies, and accordingly, an extensive need for more reliable tools and methodologies.…”