Theme 4 – Risk

The risk theme is comprised of five workpackages – WP12, WP13, WP14, WP15 and WP16 – aimed at developing tools and methods for risk assessment and risk management of engineered nanomaterials for both human health and the environment. Dr. Ir. Agnes Oomen, RIVM, the Netherlands, acts as the risk theme leader in MARINA.

Human Risk Assessment (WP12)

(WP Leader: Dr. Ir. Agnes Oomen, the Netherlands) – development of a novel risk assessment (RA) strategy for assessing the human health risks of nanomaterials, in combination with the environmental RA strategy.

  • In WP12, a flexible and efficient RA strategy is (being) developed that considers the impact of the varying properties of an ENM during the various life cycle stages on human health and combined with environmental risks. Options for grouping and sharing of data or information between ENMs or ENM- bulk are discussed. An Intelligent Testing Strategy (ITS) and an exposure assessment strategy are developed in combination with other MARINA WP9 and WP6, respectively.

Environmental Risk Assessment (WP13)

(WP Leader: Dr. Janeck Scott- Fordsmand, Denmark) – development of a novel RA strategy for assessing environmental risk, in combination with the human RA strategy.

  • In WP13, as in WP12, a flexible and efficient RA strategy is (being) developed that considers the impact of the varying properties of an ENM during the various life cycle stages, including both human and environmental risks. This is coupled with the development of an ITS. For both options for grouping and sharing of information between ENMs or ENM-bulk are discussed.

Management of Accidental Risk (WP14)

(WP Leader: Dr. Jacques Bouillard, France) – develop and test experimental methods/models to evaluate the environmental impacts of massive accidental release or explosion of nanomaterials.

  • In this WP, an approach consisting of evaluating, from small to medium scale laboratory experiments, accidental release or explosion source terms and parameters that could be scaled up to larger industrial sites so as to evaluate the potential impacts of massive release and explosion of nanomaterials on infrastructures, the environment and human health. This WP is providing inputs to the development of current standardization documents in the frame of CEN TC 352 / WG3/ PG3.

Monitoring Systems (WP15)

(WP Leader: Dr. Ari Auvinen, Finland) – propose detection and monitoring methods for engineered nanomaterials in air, water, soil and sediment.

  • In this WP, a monitoring method for nanoparticles is being developed. It is suggested that it should be a tiered method to be unambiguous, logically proceeding step by step and standardised to guarantee monitoring measurements that are comparable with each other. The results may then be used as information source for future monitoring needs when stored, e.g. in a monitoring database.
  • Deliverable: D15.3 Monitoring strategies at occupational sites.

Risk Reduction (WP16)

(WP Leader: Dr. Xue Wang, UK) – develop a Risk Reduction Strategy (RRS) with associated toolboxes covering ENM manufacture/handling.

  • In WP16, (1) data-driven models, e.g., QSAR and PBPK-PD, to provide quantitative predictions of potential risks (2) strategies to control the risk of ENM through engineering approaches, (3) multivariate statistical process control (MSPC) approaches to monitor and control processes and (4) control banding approach to control ENM exposure are (being) developed.

Grouping and Read-Across Approaches for Risk Assessment of Nanomaterials

Physicochemical properties of chemicals affect their exposure, toxicokinetics/fate and hazard, and for nanomaterials, the variation of these properties results in a wide variety of materials with potentially different risks. To limit the amount of testing for risk assessment, the information gathering process for nanomaterials needs to be efficient. At the same time, sufficient information to assess the safety of human health and the environment should be available for each nanomaterial. Grouping and read-across approaches can be utilised to meet these goals. This article presents different possible applications of grouping and read-across for nanomaterials within the broader perspective of the MARINA Risk Assessment Strategy (RAS), as developed in the EU FP7 project MARINA. Firstly, nanomaterials can be grouped based on limited variation in physicochemical properties to subsequently design an efficient testing strategy that covers the entire group. Secondly, knowledge about exposure, toxicokinetics/fate or hazard, for example via properties such as dissolution rate, aspect ratio, chemical (non-)activity, can be used to organise similar materials in generic groups to frame issues that need further attention, or potentially to read-across. Thirdly, when data related to specific endpoints is required, read-across can be considered, using data from a source material for the target nanomaterial. Read-across could be based on a scientifically sound justification that exposure, distribution to the target (fate/toxicokinetics) and hazard of the target material are similar to, or less than, the source material. These grouping and read-across approaches pave the way for better use of available information on nanomaterials and are flexible enough to allow future adaptations related to scientific developments.

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