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Risk assessors, risk managers, developers, potential applicants, and other stakeholders at many levels discuss the need for new or further risk assessment guidance for deliberate environmental releases of gene drive-modified organisms. However, preparing useful and practical guidance entails challenges, to which we offer recommendations based on our experience drafting guidance. [ABSTRACT FROM AUTHOR]

This paper proposes that generic cancer risk assessments be based on the integration of the Linear Non-Threshold (LNT) and hormetic dose–responses since optimal hormetic beneficial responses are estimated to occur at the dose associated with a 10 −4 risk level based on the use of a LNT model as applied to animal cancer studies. The adoption of the 10 −4 risk estimate provides a theoretical and practical integration of two competing risk assessment models whose predictions cannot be validated in human population studies or with standard chronic animal bioassay data. This model-integration reveals both substantial protection of the population from cancer effects (i.e. functional utility of the LNT model) while offering the possibility of significant reductions in cancer incidence should the hormetic dose–response model predictions be correct. The dose yielding the 10 −4 cancer risk therefore yields the optimized toxicologically based “regulatory sweet spot”. [ABSTRACT FROM AUTHOR]

[Display omitted] • Microplastics have been analyzed widely in the Norwegian environment. • Multi-actor discussions in Norway identified several persistent knowledge gaps. • Validation and harmonization of analytical methods are needed to advance research. • Elucidating drivers and mechanisms of microplastic toxicity is still a challenge. • Complex ecological interactions inspire adopting a precautionary approach. • Multi-actor communication is essential to define and facilitate strategic research. Given the increasing attention on the occurrence of microplastics in the environment, and the potential environmental threats they pose, there is a need for researchers to move quickly from basic understanding to applied science that supports decision makers in finding feasible mitigation measures and solutions. At the same time, they must provide sufficient, accurate and clear information to the media, public and other relevant groups (e.g., NGOs). Key requirements include systematic and coordinated research efforts to enable evidence-based decision making and to develop efficient policy measures on all scales (national, regional and global). To achieve this, collaboration between key actors is essential and should include researchers from multiple disciplines, policymakers, authorities, civil and industry organizations, and the public. This further requires clear and informative communication processes, and open and continuous dialogues between all actors. Cross-discipline dialogues between researchers should focus on scientific quality and harmonization, defining and accurately communicating the state of knowledge, and prioritization of topics that are critical for both research and policy, with the common goal to establish and update action plans for holistic benefit. In Norway, cross-sectoral collaboration has been fundamental in supporting the national strategy to address plastic pollution. Researchers, stakeholders and the environmental authorities have come together to exchange knowledge, identify knowledge gaps, and set targeted and feasible measures to tackle one of the most challenging aspects of plastic pollution: microplastic. In this article, we present a Norwegian perspective on the state of knowledge on microplastic research efforts. Norway's involvement in international efforts to combat plastic pollution aims at serving as an example of how key actors can collaborate synergistically to share knowledge, address shortcomings, and outline ways forward to address environmental challenges. [ABSTRACT FROM AUTHOR]

This study proposed a framework to estimate health risks due to exposure of mixture of nanoparticles (NPs) from surface water, for the first time, as per authors' best knowledge. The framework consisted of hazard identification, exposure assessment, dose-response assessment, risk characterization and risk management steps. Concentrations of mixture of NPs and associated ions were compiled and range of values were used for exposure estimation. The resulting concentrations of nanoparticle and metal ions in simulated digestive fluid were calculated and used to estimate exposure dose to digestive system organs during a hypothetical exposure of water during recreational activity. Exposure doses of different possible combinations of ZnO NP, CuO NP, Zn2+ and Cu2+ ions were considered. The ECHA weight-of- evidence framework was used for formulating hypotheses and collecting evidence for determining reference dose (RfD) and interaction parameter for estimating hazard interaction value (an index for risk) as per the USEPA modified weight-of-evidence method for estimating risks of binary NPs and ions. RfD values of CuO (0.0262 mg/kg/d) and ZnO NP (0.0315 mg/kg/d) were derived using information from rat-based oral toxicity studies and assumed values of uncertainty factors. The results showed that mixture of NPs under environmentally-relevant conditions do not pose any health risk. The uncertainty analysis indicated that ZnO + CuO + Zn + Cu ion suspension posed the highest risk. The switchover analysis indicated that NP concentration >0.207 mg/L resulted in risk estimate greater than 1 and pose risk. Although risk estimate was found to be smaller than 1 under the studied natural water condition, efforts should be made to continue monitoring mixture of NPs as a precautionary approach. More efforts are required to obtain data on (i)toxicity of mixture of NPs, (ii)their interaction effects, (iii)fractions of NPs reaching target organ in order to accurately predict risk. Potential benefit of this framework is in its usage for development of structure for estimating exposure risks due to mixture of NPs and ions from surface water. This can also be used to adopt methodology for gathering information on evidence required in different steps of risk assessment process, like obtaining RfD/uncertainty factor -related parameters in dose-response assessment step, deriving interaction and mixture toxicity-related parameters in risk estimation step. • Risk assessment framework for mixture of nanoparticles (NPs) in water using the USEPA modified Weight-of-evidence method. • Use of ECHA weight-of-evidence method for hypothesis development, problem formulation, data collection, weightage assignment. • Estimation of realistic dose of NPs and ions using information on dissolution of NP in simulated digestive fluid. • Significant effect of the interaction parameter of the WoE method on risk estimate. • No significant health risk due to exposures of ZnO NP or CuO NPs in surface water below 0.207 mg/L concentration. [ABSTRACT FROM AUTHOR]