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

propose it as a Method Validation Framework for use by ECVAM in
compliance with the 3R principles and we will update the OECD
test guidelines with this iTS.
Risk
i. Assessment, we will implement a database for storing
MARINA data and available data from other FP and national
projects by using the existing NAPIRAhub database; We will
implement and harmonise in silico models of exposure-doseresponse
(PBPK/PD) and QSAR models for both toxicology and
eco-toxicology and to use them as tools for Risk Assessment (RA)
(we will work with other successful projects in FP7 NMP-2010.1.3-
2). Key differences from the present RA will be identified and ENM
specific issues will be clarified. Based on the weight-of-evidence
generated in MARINA and from other projects, we will implement
a RA strategy for the humans and the environment and integrate
both strategies into an Integrated Risk Assessment (iRA) Strategy
for ENM.
ii. Management based on the results of the iRA, and in close
collaboration with industries (i.e. via case-study verification), we
will develop a Risk Reduction Strategy (RRS) in the form of a
toolboxes for (a) the management massive release risk, (b) the
assessment of monitoring systems for the control of
occupational/consumer/environmental exposure, and (c)
identification of susceptible groups (humans and other species) for
future health surveillance. We will develop guidance manuals and
SOPs and communicate them to all relevant stakeholders (e.g.
research las, industrial manufacturing, prcessing and research
labs). For both (i) and (ii), we will contribute the iRA and RRS as
part of the development of the REACH process.
iii. Other issues relevant to MARINA
MARINA will implement a strategy for (i) training of the next
generation of researchers and relevant industry stakeholders
through a series training schools and workshops and (ii)
dissemination of MARINA approach and results targeted at policyinforming
and –making bodies (e.g. OECD, EC Scientific
Commitees, EC regulatory working groups, etc.), national public
authorities, nanotechnology industries, and the wider
nanotechnology research community and citizens by means of
public forums, website and newsletter. Therefore enhancing the
public awareness about the developments of sustainable
nanotechnology through emphasis among the participants and
encouragement of transparent and direct communication to the
public. Most importantly, MARINA will collaborate with lead
institutes of Nanosciences, the forthcoming INFRASTRUCTURE FP
project, the existing nanosafety cluster activities promoted by the
EC and also the very successful FP NANOIMPACTNET project for an
effective dissemination effort. Through direct participation of
Industry Associations and dedicated industrial partners,
dissemination and uptake of RRS to key industry in different
sectors including chemical industry, cosmetics and consumer
products will be guaranteed. MARINA strives for integrated
testing, integrated assessment and modular interconnection of
knowledge and information for science-based risk management
methods. The approach is to translate scientific advancements and
methodology in contribution to shifting from toxicological studies
of specific individual nanomaterials towards more holistic health
NanoSafetyCluster - Compendium 2012
and environmental safety assessment and management that
manages overall risks. Finally, we are aware that for this large
consortium to function efficiently, a rigorous management system
must be implemented. For this reason, the management of
MARINA is divided into two fundamental areas: The administrative
and scientific management. We endeavour to manage MARINA
using the latest techniques in project management and the
expertise and experience of coordinating FP projects from the core
MARINA members.
We present an overview of the project structure (see also Fig 2),
with references to the WP that are summarised in the table below.
The text here, together with the summarised WP, describes the
MARINA project. The workplan covers both human health and
environment and is comprised of the four main themes Materials,
Exposure, Hazard and Risk.
For materials, WP3 and WP4 will obtain a panel of ENM including -
TiO2, ZnO, SiO2, CeO2, nanoAg, MWCNT – and characterise by
measuring the physico-chemical properties of these ENM
suspected of driving the adverse human and eco-effects. WP3 will
also assemble an Industrial Case Study, consisting of the physicochemical
properties (in the pristine state and in different media)
and the (eco)-toxicity profile, for each of the materials considered.
For exposure, WP5 address release scenarios, WP6 will develop a
tiered human exposure assessment approach
(Occupational/Consumer exposure scenarios) while WP7 and WP8
will do the same for the environment.
For hazard, WP9 and WP10 are specifically for the human and ecotoxicity
of ENM. WP11 is for omics-based system toxicology
approaches relevant to both humans and the environment.
For risk, the assessment of human and environmental risks is
implemented in WP12 and 13. WP14 is dedicated to the
management of accidental risk while WP15 is to develop and
implement monitoring systems. WP16 is to develop a strategy for
risk reduction which include the derivation of control limits,
control banding and the exploration of new ENM synthesis which
be used for substitution.
Finally, as a FLAGSHIP programme, we will devote two WP (17 and
18) for training and dissemination targeted at specific relevant
stakeholders of NANOSAFETY. We are committed to providing
long-lasting impact in the area of nanosafety and risk assessment,
in Europe and at the international level.
The relation between the WP is illustrated in Figure 1.
5 Impact
MARINA is expected to make a significant and long-lasting impact
on the European objectives for the safe, integrated and
responsible approach to the development of Nanotechnology.
Specifically, for the development of comprehensive understanding
of the properties, interaction and fate of ENM in relation to human
health and environment, MARINA is a multidisciplinary consortium
of 46 organisations at the leading edge of European and worldwide
research on ENM risk issues or industrial commercialisation of
ENM and their products. As inputs we will incorporate state-of-theart
scientific findings, including those of over ten FP projects in the
Compendium of Projects in the European NanoSafety Cluster 71