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Timing, hosts and locations of (grouped) events of NanoImpactNet

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for risk analysis, these tools need to be applied, modified <strong>and</strong><br />

verified for nanomaterials. Previously used st<strong>and</strong>ard approaches to<br />

risk management, control <strong>and</strong> reduction need to be proven for the<br />

novel paradigm presented by nanomaterials. Thus, the<br />

development <strong>of</strong> nanotechnology-based products needs to be<br />

complemented with appropriate validated methods to assess,<br />

monitor <strong>and</strong> reduce the potential risks <strong>of</strong> engineered<br />

nanomaterials (ENM) to human health <strong>and</strong> the environment. Public<br />

mistrust <strong>of</strong> any new technology is <strong>of</strong>ten high, <strong>and</strong> demonstrating<br />

‘safe’ products <strong>of</strong> nanotechnology will enhance the confidence <strong>of</strong><br />

consumers, workers <strong>and</strong> other stakeholders. Furthermore, these<br />

measures must be validated <strong>and</strong> integrated in an overarching,<br />

coherent strategy for regulators <strong>and</strong> industry to adapt them. Thus,<br />

a safe <strong>and</strong> environmentally responsible nanotechnology will<br />

safeguard current <strong>and</strong> future global investments <strong>and</strong> will be the<br />

key to the sustainability <strong>of</strong> this industry.<br />

While there are st<strong>and</strong>ard procedures for product life cycle analysis,<br />

exposure, hazard, <strong>and</strong> risk assessment for traditional chemicals, is<br />

not yet clear how these procedures need to be modified to<br />

address all the novel properties <strong>of</strong> nanomaterials. There is a need<br />

to develop specific reference methods for all the main steps in<br />

managing the potential risk <strong>of</strong> ENM. The aim <strong>of</strong> MARINA is to<br />

develop such methods. MARINA will address the four central<br />

themes in the risk management paradigm for ENM: Materials,<br />

Exposure, Hazard <strong>and</strong> Risk. The methods developed by MARINA<br />

will be (i) based on beyond-state-<strong>of</strong>-the-art underst<strong>and</strong>ing <strong>of</strong> the<br />

properties, interaction <strong>and</strong> fate <strong>of</strong> ENM in relation to human<br />

health <strong>and</strong> the quality <strong>of</strong> the environment <strong>and</strong> will either (ii) be<br />

newly developed or adapted from existing ones but ultimately,<br />

they will be compared/validated <strong>and</strong> harmonised/st<strong>and</strong>ardised as<br />

reference methods for managing the risk <strong>of</strong> ENM. MARINA will<br />

also develop a strategy for Risk Management including<br />

monitoring systems <strong>and</strong> measures for minimising massive<br />

exposure via explosion or environmental spillage<br />

2 Objectives<br />

The specific objectives <strong>of</strong> MARINA are:<br />

1. For Materials, to obtain reference nanomaterials for testing;<br />

to develop validated methods for characterising the physicochemical<br />

properties <strong>of</strong> ENM as pristine materials, in biological<br />

matrices, in environmental samples <strong>and</strong> field detection; to<br />

isotope-label ENM for their use in bio-distribution studies<br />

2. For Exposure, to conduct exposure assessment in the<br />

workplace throughout the life-cycle <strong>of</strong> a ENM, developing<br />

different exposure scenarios. To assess the fate <strong>and</strong> behaviour<br />

<strong>of</strong> ENM in soil/sediment/water. To characterize the actually<br />

released ENM (aged ENM) <strong>and</strong> compare them to the pristine<br />

ENM. To evaluate, as part <strong>of</strong> a performance assessment,<br />

different approaches to conduct exposure assessment for use in<br />

the MARINA integrated risk assessment.<br />

3. For Hazard, to address the knowledge gap, especially in areas<br />

<strong>of</strong> non-genomic toxic mechanisms, toxicogenomics, proteomics<br />

NanoSafetyCluster - Compendium 2012<br />

<strong>and</strong> metabolomics by developing new test systems; to develop<br />

reference methods for in vitro toxicology tests (including <strong>and</strong><br />

fully incorporating those developed in other FP projects) by<br />

means <strong>of</strong> a scientific validation strategy; to implement in vivo<br />

dose-response models <strong>of</strong> healthy <strong>and</strong> susceptible subjects<br />

exposed through repeated dosing to ENM via inhalation,<br />

ingestion, intravenous injection <strong>and</strong> dermal exposure; to<br />

develop <strong>and</strong> scientifically validate in vitro <strong>and</strong> in vivo tests for<br />

soil/sediment/aquatic toxicity <strong>and</strong> secondary poisoning.<br />

4. For Risk, to combine phase (1), (2) <strong>and</strong> (3) in developing<br />

reference methods for assessing the health <strong>and</strong> environmental<br />

risk posed by ENM; to develop a strategy for Risk Management<br />

including onitoring systems <strong>and</strong> measures for minimising<br />

massive exposure via explosion or environmental spillage.<br />

MARINA is to achieve the objectives described above in 48<br />

months.<br />

3 The MARINA approach<br />

The European Commission, to date, has funded some 15 projects<br />

relevant to health <strong>and</strong> safety issues regarding ENM. This<br />

commitment is set to continue in the future. At the national level,<br />

there are other similar efforts 3,4 . However, to date, the valuable<br />

results generated from these projects have in the main been<br />

unabled to generate concepts, methodology <strong>and</strong> data which have<br />

been practically used for risk assessment <strong>and</strong> management.. Thus,<br />

there is clearly a need to use the most up-to-date date available<br />

information <strong>and</strong> methodology for guidance on health <strong>and</strong> safety<br />

risk management to industry <strong>and</strong> regulators. To respond to this<br />

need, in MARINA, we have created a consortium consisting <strong>of</strong> first<br />

class scientists <strong>and</strong> organisations with a track records for research<br />

in Health <strong>and</strong> Safety Issues <strong>of</strong> ENM. Most importantly,<br />

• we have representatives from more than ten FP projects 1 . Our<br />

aim is to take the beyond the state-<strong>of</strong>-the-art results from<br />

these projects <strong>and</strong> use them for creating validated reference<br />

tools for Risk Assessment <strong>and</strong> Management<br />

• we recognise the relevance <strong>of</strong> our results to industry<br />

therefore we have involved the direct participation <strong>of</strong> the<br />

Nanotech Industries Association 2 <strong>and</strong> industrial key partners<br />

such as BASF <strong>and</strong> Nanocyl.<br />

• we also recognised the geopolitical <strong>and</strong> economical<br />

1<br />

The FP projects are: FP6 PARTICLE_RISK, NANOSH,<br />

NANOINTERACT, NANOSAFE2, FP7 NANOMMUNE, NANOTEST,<br />

ENPRA, NEURONANO, NANODEVICE, NANOLYSE,<br />

NANOIMPACTNET, NANEX, ENNSATOX, NANOFATE, NANOHOUSE<br />

<strong>and</strong> ObservatoryNANO.<br />

2<br />

NIA is also involved in another proposal on the same call<br />

(NMP.2010.1.3-1: NanoREFORM); this involvement allows the<br />

establishment <strong>of</strong> added-value components to both projects <strong>and</strong><br />

benefits the nanotechnology research <strong>and</strong> industries community:.<br />

Compendium <strong>of</strong> Projects in the European NanoSafety Cluster 67

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