Abstract

An Environmental Risk Assessment (ERA) for nanomaterials (NMs) is outlined in this paper. Contrary to other recent papers on the subject, the main data requirements, models and advancement within each of the four risk assessment domains are described, i.e., in the: (i) materials, (ii) release, fate and exposure, (iii) hazard and (iv) risk characterisation domains. The material, which is obviously the foundation for any risk assessment, should be described according to the legislatively required characterisation data. Characterisation data will also be used at various levels within the ERA, e.g., exposure modelling. The release, fate and exposure data and models cover the input for environmental distribution models in order to identify the potential (PES) and relevant exposure scenarios (RES) and, subsequently, the possible release routes, both with regard to which compartment(s) NMs are distributed in line with the factors determining the fate within environmental compartment. The initial outcome in the risk characterisation will be a generic Predicted Environmental Concentration (PEC), but a refined PEC can be obtained by applying specific exposure models for relevant media. The hazard information covers a variety of representative, relevant and reliable organisms and/or functions, relevant for the RES and enabling a hazard characterisation. The initial outcome will be hazard characterisation in test systems allowing estimating a Predicted No-Effect concentration (PNEC), either based on uncertainty factors or on a NM adapted version of the Species Sensitivity Distributions approach. The risk characterisation will either be based on a deterministic risk ratio approach (i.e., PEC/PNEC) or an overlay of probability distributions, i.e., exposure and hazard distributions, using the nano relevant models.

Highlights

  • Concern has been raised regarding whether engineered Nanomaterials (NMs) cause environmental harm

  • Environmental Risk Assessment (ERA) correspond to the three information‐gathering pillars by [6]; the “risk characterisation” domain corresponds to the fourth pillar defined by [6] containing defined the “risk characterisation”

  • Once released into the environment, the environmental distribution may be assessed with the fate models, and the within-compartment fate of NMs is determined by several physicochemical processes such as aggregation, sedimentation, particle-deposition, dissolution, etc

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Summary

Introduction

Concern has been raised regarding whether engineered Nanomaterials (NMs) cause environmental harm. The inadequacy includes, for example, an insufficient description of the relevant material characteristics (e.g., as these must be used in fate and exposure models), a lack of relevant exposure models (e.g., the present models do not take NM behaviours into account), a lack of knowledge on which species are mostly affected by NMs (e.g., the present approaches prioritise aquatic pelagic organisms, whereas for NMs the organisms most likely affected are terrestrial), and how to include such in risk characterisation (e.g., there is presently no way to account for NM relevant parameters) Based on this concern and insight, novel tools and approaches to evaluate NM risk have been suggested, as reviewed by [1,2]. Assessment (ERA) strategy that, contrary to the previously mentioned approaches, includes the most recent environmental model types in the different domains of risk assessment, i.e., material, exposure, hazard and risk characterisation This ERA strategy is an exposure driven process comprising two general phases covering the entire life cycle of the material. For further discussion regarding grouping of nanomaterials as proposed by MARINA, (see [15])

The Environmental Risk Assessment Strategy
2: Risk assessment”
Materials
Materials and Methods
Identification of Exposure Scenarios
Models for RES Identification
Identification of Exposure
Hazard
Risk Characterisation
Conclusions
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