The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials

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.

Keywords: exposure-driven; nanomaterials; problem framing; risk assessment strategy.

Figure 1

Schematic overview of the MARINA Risk Assessment Strategy, consisting of: (1) an overarching “Phase 1: Problem framing” (orange disc); (2) the iterative “Phase 2: Risk assessment” (green discs: cyclic evaluation process and a finalization step); (3) the three information-gathering pillars: Exposure (red), Fate/Kinetics (green) and Hazard (blue) and (4) the Risk characterization pillar (purple). Phase 1 consists of two steps: (a) Data evaluation; and (b) identification of Relevant Exposure Scenarios (RESs). The iterative evaluation process of Phase 2 consists of four steps: (a) Risk characterization including risk management options (RMOs); (b) Defining data needs; (c) Data gathering and (d) Data evaluation. (See text for further explanation).

Figure 2

Schematic view of the three information-gathering pillars on the left and the risk characterization pillar on the right and their placing in the respective phases and steps of the MARINA Risk Assessment Strategy.