Abstract
An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.
Highlights
Engineered nanomaterials (ENM) are being rapidly developed with many variations of size, shape, structure, and surface modifications, for example, and to such an extent that risk assessment of these engineered nanomaterial (ENM) is a challenging process
The present paper describes the blueprint of this strategy, which will be operationalized in other papers [16,17] or later project reports
The aim of Phase 1 in the Managing Risks of Nanoparticles (MARINA) Risk Assessment Strategy is to identify Relevant Exposure Scenarios (RESs) throughout an ENM’s life cycle and to verify whether exposure in these scenarios may potentially lead to adverse health and/or ecological effects
Summary
Engineered nanomaterials (ENM) are being rapidly developed with many variations of size, shape, structure, and surface modifications, for example, and to such an extent that risk assessment of these ENMs is a challenging process. Not in the least this is because ENMs of a particular chemical composition may consist of a population of primary particles, aggregates and agglomerates of e.g., various sizes, and different surface coatings with characteristics that may change over time [1] Their physico-chemical characteristics may influence their general environmental/ambient fate, the exposure scenarios, the subsequent fate in ecosystems and kinetics within an organism (ecological or human), and on the subsequent extent and type of biological effects, on potential health and environmental risks [2,3,4,5,6]. Requiring full testing of slightly different ENMs may lead to unreasonable costs and at the same time may challenge the intention to reduce animal testing Taking up all these issues requires a risk assessment strategy that considers the impact on human health and the environment of the variation in properties of an ENM during all the relevant life cycle stages, from production to formulation, (consumer) use, recycling and, waste. The presented risk assessment strategy is expected to serve the purpose of different users such as industry during the design-phase of an ENM or by regulators within a regulatory framework
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