Conference-Booklet 2nd EU-Asia Dialogue on Nanosafety 29.10.2018, Vienna - BioNanoNet
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2nd EU-Asia Dialogue on Nanosafety
29.10.2018, Vienna
Conference-Booklet
2nd EU-Asia Dialogue on Nanosafety
Content
Message from the Host and Cooperation Partners ................................................................3
Statement from the EU-NSC coordination team.................................................................. 8
Organisers of 2nd EU-Asia Dialogue on Nanosafety............................................................... 9
Agenda ...............................................................................................................................10
Welcome-Session................................................................................................................12
Oral presentations .............................................................................................................. 13
Break-Out sessions .............................................................................................................38
Final wrap-up session .........................................................................................................43
Statement from the organisers of the 3rd EU-Asia Dialogue on Nanosafety .........................44
Imprint:
Media owner: Federal Ministry for Transport, Innovation and Technology
Radetzkystrasse 2, 1030 Vienna
https://www.bmvit.gv.at
Contact: Alexander Pogany
alexander.pogany@bmvit.gv.at | +43 1 711 62 65 - 3203
1
2nd EU-Asia Dialogue on Nanosafety Message fr0m the Host and Cooperation Partners World class scientific innovation and industry research allows us to transform ideas into commercially successful products and services. Nanotechnology as a key enabling technology is expected to help push forward innovative developments in a diversity of technology fields and social applications. The potential uses of nanotechnology are manifold, ranging from electronics and automotive technology to consumer products and environmental technology. Ensuring the safe and sustainable development and application of the nanotechnologies is essential for commercialisation of nanotech-products and for creating added value in Austria. Within the frame of the “Austrian Nanotechnology Action Plan” Austria has set up a research programme on Nanosafety with the goal to assess possible environment, health and safety risks in Nanotechnology and builds up the necessary level of expertise in its own research system. As no country alone can cover the full range of Nanosafety research cooperation and coordination in the European and international context is essential. Within the frame of a bilateral agreement between the Austrian Research Promotion Agency (FFG) and the Chinese Academy of Science (CAS) the Austrian Ministry for Transport, Innovation and Technology could fund several joint nanotech-projects between Austrian Industry and research organisations and institutes of CAS, also in the area of Nanosafety. Since 2013 the BMVIT is full member of the “Asia Nano Forum”. Within this network we could contribute to several initiatives, especially in workshops on commercialisation of nanotechnology and nanosafety and will do for sure in the future. Additionally Austria is with its company Bionanonet member of the coordination team of the European Nanosafetycluster. I am sure the “2nd EU-Asia Dialogue on Nanosafety” hosted and initiated by the BMVIT and implemented together with the European Commission, the ANF and the BioNanoNet will foster cooperation between European and Asian stakeholders in Nanosafety. I wish all participants a successful event and the BMVIT for sure will help to increase the cooperation with Asia and globally in the area of nanotechnology and nanosafety in the future. Sincerely, Nobert Hofer Federal Ministry for Transport, Innovation and Technology 3
2nd EU-Asia Dialogue on Nanosafety
Horizon 2020 (H2020) aims at supporting research in the EU to achieve leadership in Enabling
and Industrial Technologies (LEIT), thus supporting Key Enabling Technologies (KET) for
European growth. Nanotechnologies is a very important part of the programme. It can only
succeed if all safety concerns are adequately addressed at global level. The programme on
Nanotechnologies, Advanced Materials, Biotechnology and Advanced Manufacturing and
Processing (NMBP) supports a world class programme to address these concerns which
integrates the scientific research with the regulatory and market phases. It attaches great
significance to civil society’s involvement for risk governance, and strongly encourages
international cooperation. The latter is in line with the overall aim of H2020 that makes the
EU research actions Open to the World.
When regulating technologies one aim is to ensure that known and quantified risks stay
below a defined maximum acceptable level. Currently, the application of safe-by-design to
nanomaterials as a means of reducing unacceptably high known risks and for engineering-out
known but not quantified risks is being developed. Furthermore, the need for safe products is
underpinned by the precautionary principle, which is closely linked to governance, including
risk governance. Global effort is needed for being able to quantify risk in globally agreeable
manner, for fixing criteria for assessment, for establishing methods for safe-by-design
products and processes, and for implementing existing and future regulation reliably.
The EU-nanosafety research community strongly welcomes the cooperation with the Asian
Forum and this not only on strict terms of science and technology, but also in terms of
regulatory research, standards, reference materials and methods, databases and informatics,
and, most important development of the necessary skills to handle the new challenges.
With Best regards,
Peter Dröll
European Commission
5
2nd EU-Asia Dialogue on Nanosafety
It is my great pleasure to welcome all of you to the 2nd Asia-EU Dialogue on Nanosafety to
be held in Vienna, Austria on October 29, 2018. This year, the Asia Nano Forum (ANF) jointly
organizes the meeting, as well as the 1st Dialogue held in Teheran, Iran last November.
The ANF is an international networking organization founded in 2004, aiming to foster
Nanoscience and Nanotechnology in Asia Region by creating mechanisms to share
information, human and physical resources and expertise. It is one of our major objectives to
promote and coordinate standardization and safety of nanotechnology products and related
measurements. We believe this activity is very important because the safety is an essential
and determining issue in actual commercialization and dissemination of Nanotechnology. To
solve the Nanosafety issue, the scientific knowledge is obviously required based on reliable
and convincing data, but at the same time, the societal acceptance is of equally importance.
Thus, we need to enhance proper public awareness and promote correct knowledge to prevail
in the community.
In this context, this Dialogue between EU and Asia will provide a very good forum for
comprehensive discussion of this issue. While a lot of experiences and knowledge have
been accumulated in EU and Asia, there are certainly cultural differences in these regions,
leading to different common attitudes towards Nanosafety. Accordingly, I hope we all take
this opportunity to share our experiences and harmonize efforts in these two regions. Please
enjoy the meeting.
With best regards,
Toshihiko Kanayama
President, ANF
7
2nd EU-Asia Dialogue on Nanosafety Statement from the EU-NSC coordination team “Position of the EU-Asia dialogue in the EU NanoSafety Cluster” International cooperation and collaboration is a key focus for the EU NanoSafety cluster (NSC). This cluster is overarching the many safety projects funded by the EU, most of which are actively building links with partners around the globe to work towards harmonisation of nanomaterials test guidelines. It is also a source of scientific information supporting regulatory decision making. Furthermore, activities within the NSC are directed toward developing tools to ease the route to market for nano-based innovations. The mission of the Asia Nano Forum (ANF) is aligned to that of the NSC: promoting responsible development and application of nanotechnology for the benefit of education, society, the environment and the partner economies. This is achieved by fostering international collaboration and offers a perfect partnership opportunity. Indeed, the engagement level from the NSC and the ANF is evidenced by the very short timeframe since the 1st Asia-Europe Dialogue on NanoSafety and NanoProduct Specification which was successfully hosted by the Tehran University of Medical Sciences (TUMS) on the 28 – 30 November 2017. Several areas for cooperation and collaboration between the ANF and the NSC were identified at the 1st Dialogue meeting, including: • sharing of scientific data, • harmonisation and knowledge exchange on social dialogue and risk governance, • scientific collaboration including co-applications for funding in the areas of nanosafety and nanomedicine characterisation, and • cooperation on nano-certification and nano-standardisation efforts. Now, this 2nd EU-Asia Dialogue on NanoSafety offers a great opportunity to build on these initial exchanges, to solidify the relationships and points of contact, and to move forward in the development of the collaborative research and standardisation agenda. Thus, the topics for the four breakout sessions at this 2nd EU-Asia dialogue map to these four key areas mentioned above. The meeting aims to facilitate development of concrete joint actions, and establishment of an action plan to convert the ideas into practice.In the long run, the EU-Asia Dialogue on Nanosafety has high strategic importance to the NSC, and is poised to become the flagship example of effective international integration and leadership for the global Nanosafety community. With best regards, Eva Valsami-Jones, Iseult Lynch, Flemming Cassee, Andreas Falk 8
2nd EU-Asia Dialogue on Nanosafety
Organisers of 2nd EU-Asia
Dialogue on Nanosafety
About the EU NanoSafetyCluster, co-organizer
The EU NanoSafety Cluster maximises the synergies between European-level projects
addressing the safety of materials and technologies enabled by the use of nanoparticles.
The studied aspects include toxicology, ecotoxicology, exposure assessment, mechanisms of
interaction, risk assessment and standardisation. The Cluster is an initiative of the European
Commission Directorate-General for Research and Innovation (DG RTD), which sponsors
these large projects. Overall, Europe targets safe and sustainable nanomaterials and nano-
technology innovations. Cluster projects contribute to assuring environmental health and
safety (EHS) of this Key Enabling Technology. The Cluster also is an open platform for dia-
logue and exchange, bringing together researchers, regulators, administrators, industry, and
civil society representatives.
Synergy among these projects, collaboration for maximising impact, policy elaboration,
planning of future actions, and international cooperation are the main aims of the NanoSafety
cluster, projects and stakeholders open forum. The main objectives of the NanoSafety cluster
are:
• To facilitate the formation of a consensus on nanotoxicology in Europe
• To provide a single voice for discussions with external bodies
• To avoid duplicating work and improve efficiency
• To improve the coherence of nanotoxicology studies and harmonize methods
• To provide a forum for discussion, problem solving and planning R&D activities in Europe
• To provide industrial stakeholders and the general public with appropriate knowledge on
the risks of NanoParticles and nanomaterials for human health and the environment.
About BioNanoNet Forschungsgesellschaft mbH, co-organizer
BioNanoNet Forschungsgesellschaft mbH (BioNanoNet) is an Austria based scientific
network that specializes in the Key Enabling Technologies nanotechnology and biotechnology
on a national and international basis, with the emphasis on (1) nanotoxicology, (2)
sensortechnologies, as well as (3) health, safety, (nano-)medicine and additionally supports
projects in coordination, management, dissemination and communication. BioNanoNet
is a European key player in the field of nanosafety, specialized in developing nano-safety-
by-design strategies together with researchers and industry.BioNanoNet has the clear aim
of driving innovative interdisciplinary research by supporting the cooperation by bringing
together scientific experts to gain critical mass for thematic areas, to initiate, set up and
manage national as well as international research projects and to add value by providing
nano-safety strategies tailored to the needs of organisations.
BioNanoNet is scientific organizer of the 2nd EU-Asia Dialogue on Nanosafety, October 2018,
Vienna, Austria, and will support the further development and future events to strengthen
the dialogue globally.
92nd EU-Asia Dialogue on Nanosafety
Agenda
09:30 – 10:00 Welcome & Arrival
10:00 – 10:10 Welcome addresses
• Alexander Pogány (Austrian Ministry for Transport, Innovation and Technology)
• Georgios Katalagarianakis (European Commission)
• Toshihiko Kanayama (Asia Nano Forum President)
10:10 – 10:20 André Gazsó, (Austrian Academy of Sciences): “Risk governance in Austria”
10:20 – 10:40 Ali Beitollahi (Iran Nanotechnology Initiative Council): “Asia-EU Dialogue on
Nanosafety and Nanocertification: A Platform Towards Enhanced Synergy”
10:40 – 12:00 Key Note Lectures
• Rong Cai (National Center for Nanoscience and Nanotechnology, Chinese Academy of
Science): „The nano-bio interactions: from biological effects to design by nanosafe ty”
• Barbara Rothen-Rutishauser (Adolphe Merkle Institute, Switzerland): „Assessing the
hazard of nanomaterials for humans with in vitro tools – how far we are and where to go”
• Il Je Yu (HCTm Aerosol and Toxicology Research Center, Korea): “Biokinetics of Co-
exposed Nanomaterials”
• Claus Svendsen (Center of Centre for Ecology & Hydrology, United Kingdom):
“Realistic environmental exposure and ecological risk assessment”
• Ramjitti Indaraprasirt (Nanotec Thailand): „Nano-safety & Standardization Initiative
in Thailand”
• Rawiwan Maniratanachote (Nanotec Thailand): “Safety Assessment of Nanomateri
als using Alternative Methods”
12:00 – 12:15 Q&A Session
12:15 – 12:30 Anke Jesse (Federal Ministry for the Environment, Nature Conservation and
Nuclear Safety, Germany): “Malta Initiative – a joint approach to adopt the
OECD TG to the needs of nanomaterials”
12:30 – 13:30 Lunch
13:30 – 15:00 Breakout sessions Locations: Room Seidl, Brühl, Segel 4 and Segel 5
• Scientific Data Collaboration, Chair: Iseult Lynch (University of Birmingham, United
Kingdom)
• Nano-Certification, Nanostandardisation, Chairs: Damjana Drobne (University of
Ljubljana, Slovenia), Emeric Frejafon (INERIS. France)
102nd EU-Asia Dialogue on Nanosafety
• Social Dialogue and Governance, Chairs: Andreas Falk (BioNanoNet, Austria),
Flemming Cassee (RIVM, The Netherlands)
• Nanosafety and Nanomedicine Characterisation, Chair: Matteo Santin (University of
Brighton, United Kingdom)
15:00 – 15:30 Coffee break
15:30 – 16:00 Presentations of breakout session results (session chairs)
16:00 – 17:00 Best practice examples & projects of EU NanoSafety Cluster
• Keld A. Jensen (National Research Centre for the Working Environment, Denmark):
“caLIBRAte - Creating a Web-based HUB for tested Tools for Governance of
Emerging and Existing NanoRisks”
• Andrew Nelson (University of Leeds, UK): “Third generation high throughput on-line
platforms for nanosafety screening”
• Vicki Stone (Heriot-Watt University, Scotland): “GRACIOUS framework for grouping
and read-across of nanomaterials for regulatory risk assessment and safe-by-design”
• Emeric Frejafon (INERIS, France): “How to move forward on the harmonisation of
the expertise in nanosafety for a safer innovation in Nanotech, lessons learned from
EC4SafeNano”
• Peter Ertl (Technical University Vienna, Austria): “Next generation luminescence up
conversion nanomaterials for bioimaging with approved nanosafety by microfluidic
cell assays”
17:00–17:05 Group photo of 2nd EU-Asia Dialogue on NanoSafety
17:05 – 17:30 pre-IndTech2018-conference talk: “Role of Nanosafety in Industrial
Technology” by Peter Dröll (European Commission)
17:30 – 18:00 Discussion, wrap-up of the day and way towards the 3rd EU-Asia Dialogue on
Nanosafety; Chair: Alexander Pogány (Ministry for Transport, Innovation
and Technology) Panel: Peter Dröll (European Commission), Ali Beitollahi
(Iran Nanotechnology Initiative Council), Anke Jesse (Federal Ministry for the
Environment, Nature Conservation and Nuclear Safety), Eugenia Valsami-
Jones (University of Birmingham)
18:00 – 19:00 Networking cocktail
112nd EU-Asia Dialogue on Nanosafety Welcome-Session Alexander Pogány has hismaster in Microbiology and worked for about 3 years at Baxter Bioscience as validation expert in the Quality Control. In 2004 he joined the Austrian Ministry for Transport, Innovation and Technology and works now as senior expert in the national and international research policy in the area of industrial technologies (Nanotechnology, Materials research and Production). This includes the coordination of several research programmes. He is Austrian Delegate for the H2020 NMBP Framework program, and the Working Party BNCT (Bio, Nano and Converging Technologies) and WPMN (Manufactured Nanomaterials) of the OECD. Georgios Katalagarianakis graduated as mining and metallurgy engineer from the National Technical University of Athens in 1976. He obtained a diploma on mechanical engineering from the University of Thessaloniki in 1989 and a PhD degree from the Imperial College of Science, Technology and Medicine in 1998. He has worked for ten years in the underground mining industry and the mineral resources authority of Greece before joining the European Commission in 1989 as administrator. He has been responsible for European research in the fields of mining and metallurgy, recycling, construction and maintenance of buildings and civil infrastructure, tunnelling, industrial safety and ergonomics, use of nanomaterials in buildings, etc. He is currently responsible for research in the area of nanotechnology safety. Toshihiko Kanayama started research on semiconductor fabrication process technologies in 1977 at the Electrotechnical Laboratory and moved to the Joint Research Center for Atom Technology (JRCAT) in 1993 to develop atomic-scale silicon processing and characterization technology as a group leader. Since 2001, he led semiconductor research centers in AIST as an executive director and the director. He became Vice-President of AIST in 2010 and has been Senior Vice- President of AIST since 2014. 12
2nd EU-Asia Dialogue on Nanosafety
Oral presentations
“Risk governance in Austria”
André Gazsó
(Austrian Academy of Sciences)
Contact: agazso@oeaw.ac.at
André Gazsó studied Biology and Philosophy. He is senior scientist for safety and risks of
new and emerging technologies at the Institute of Technology Assessment of the Austrian
Academy of Sciences. Since 2013 André Gazsó is Chairman of the Austrian Nanotechnology
Information Commission of the Austrian Ministry of Health. Since 2017 he is member of
the scientific board of the German Federal Institute for Risk Assessment (BfR) On the
national level Dr. Gazsó is invited expert for SKKM (National Crisis and Disaster Protection
Management, Ministry of Internal Affairs) and several standardisation committees on risk
analysis, risk management and nanotechnologies. André Gazsó is involved in several risk
and safety projects mainly concerning nanotechnologies, gene technology and information
and communication technologies. Since 2013 he is responsible for the project “NanoTrust”
at the ITA, which has recently been elongated until 2020. He is lecturer on risk analysis and
risk governance issues regarding new and emerging technologies and holds several teaching
positions at the University of Vienna, the University of Natural Resources and Life Sciences,
Vienna, and the University of Applied Sciences FH-Campus, Vienna and has supervised more
than 30 scientific thesis projects.
Abstract:
New technologies such as nanotechnologies involve new materials and products, e.g., in
medicine, cosmetics, optics, or construction, but safety and governance issues have not
been an equal object of systematic investigation. The NanoTrust project was therefore
established to collect the knowledge available on safety and regulatory issues and to analyse
it. Furthermore, the communication of this knowledge to the public as well as to decision-
makers has been part of the project form the beginning, thus helping it to organize an
exchange of knowledge and to contribute to qualified political decision making.
According to the logic of the project, the previous evolution of NanoTrust can be divided
into several phases, beginning with the first contacts to the management of the Austrian
Nanotechnology Initiative (NI). After a preparatory phase starting in 2003 to create certain
awareness for nanosafety topics, the NanoTrust project was started in 2007 as a consequence
of the need to have a profound research activity on nano risk governance issues. During this
first period (2007-2010) the main network for developing the Austrian nanotechnology action
plan was established. The next NanoTrust period (up to 2013) was devoted to introducing
132nd EU-Asia Dialogue on Nanosafety the internal and external communication instruments (e.g., NanoTrust dossiers). Since 2013 NanoTrust 3 has been part of a more formal nano governance system, whose functions include holding the chair of the Austrian Nano Information Commission, which is part of the Austrian Ministry of Health. In the meanwhile NanoTrust has been extended once more until 2020 by agreement of the concerned ministries (i.e. Technology, Health, Environment and Social Affairs). Additionally to the previous tasks the main goal of NanoTrust will be to rearrange the scope of work to identifying new and advanced materials which could be of regulatory relevance in the near future. The NanoTrust project shows several distinctive features that may be indicative for TA’s role in assessing emerging technologies. Originally, the project was intended to ‘investigate risk and safety relevant issues regarding the use of nanotechnologies’. However, risk analysis and evaluation rules require that system limits be properly set in order to ensure the validity of results. For nanotechnologies, the necessary focus on a very early phase of development entails extending the system limits far into the future, blurring statements on development paths to a greater or lesser degree. Therefore, uncertainties emerge rather than risks. The main project aim was to create robust and regulatory relevant knowledge. The high level of uncertainty, however, required that the process of knowledge creation was mostly organized in the form of transdisciplinary expert dialogues. As a consequence, NanoTrust indulged in a variety of expert networks and risk assessment committees right from the beginning. These developments were extensively presented and discussed in a book (Gazsó & Haslinger, Springer 2014). As the project developed into its being a part of the regulatory system, NanoTrust not only provided reliable information and evaluated risk and safety relevant knowledge. Its role grew to also include the task of initiating joint activities, coordinating and eliciting discussions, and even suggesting aims and visions to be shared among partners in order to jointly organize the generation of new knowledge. These activities can only be credibly performed if the TA researchers’ roles within such networks are unambiguous and are openly communicated to the partners. Therefore, the role of the NanoTrust project members had to (and still have to) be carefully reflected. Eventually, the decision was taken to adopt a role Roger Pielke would call an ‘honest broker of knowledge’. 14
2nd EU-Asia Dialogue on Nanosafety
“Asia-EU Dialogue on Nanosafety an Nano-
certification: A Platform Towards Enhanced Synergy”
Ali Beitollahi
(Iran Nanotechnology Initiative Council)
Contact: beitolla@iust.ac.ir
Affiliation:
Iran Nanotechnology Initiative Council (Director of international collaboration and
standardization departments)/ School of Metallurgy and Materials Eng., Iran University of
Science and Technology (IUST), Tehran, Iran.
Educational History:
• PhD, Leeds University, Materials Science, U.K. 1992.
• Post Doc., Leeds University, U.K .1992- .
Professional history:
• Materials and Energy Research Center (MERK), Tehran, Iran, 1982-1986, as research
assistant.
• Leeds University, School of Materials, Thin Film Group, 1992- as Post Doc.
• Full Professor at Dept. of Metallurgy & Materials Eng, IUST, 1993-till now.
• Supervised more than 80 MSc and 12 PhD students on advanced and nanomaterials.
• Published more than 170 papers in different national and ISI journals.
• Led and co-led 8 international nanotechnology standards in ISO/TC229 since 2006.
Industrial research projects: More than 20 successfully finished industrial research projects
supported by various Iranian local industries mainly in the field of advanced materials and
nanomaterials.
Industrial consultation:
• Iranian electronic industries.
• Magnetic ferrite Co. Ltd.
Establishment of Lab: Electroceramic& magnetic ferrite, Nanotechnology Center (IUST).
Membership in various institutions & scientific societies:
• Member of Iranian nanotechnology initiative council 2001- till now.
• Member of director board of Iranian nanotechnology society.
• Director of Iranian nanotechnology infrastructure development committee.
• Director of Iranian nanotechnology standardization committee.
• Member of director board of Center of excellence for advanced materials (IUST).
• Member of director board of Iranian ceramic society.
152nd EU-Asia Dialogue on Nanosafety Awards granted: • Top scientist IUST (2007). • Top scientist amongst all research institutions and universities in Tehran province (2008). • Best research award, Mobarakeh Steel Complex (2003). Area of expertise: • Nanomaterials, Advanced ceramics, Nano magnetic materials, Mesoporous materials Abstract: Asia and Europe are two major players in advancement of nanotechnologies. Nanostandardization and nanosafety are key elements for safe and responsible development and commercialization of nanotech products. Both Asian and European member of economies have put considerable efforts in these important issues. At EU level, large number of nanosafety related programs and infrastructures have been launched. Further, relevant regulatory institutions have also been active for developing the necessary regulations. On the other hand, in Asia, there have been considerable activities in nanosafety, nanostandardization and regulation as well. Particularly, there is a good level of experience in Asia regarding the certification of nanotechnology products in several Asian countries. Overall, there is a good level of complementarity between achievements and activities between the two continents which can benefit both sides. Given the bright vision of economic cooperation between the two economic blocks, along with rising share of nanotechnology products in global economy, the need to closer collaboration in various levels between different layers of stakeholders in both continents is being felt strongly more than ever. In this respect, harmonization of relevant activities in the areas such as nanostandardization, regulations, nanosafety assessment protocols, etc. are among the major issues to be considered by member of economies of two continents. The materialization of such goals demand the establishment of a platform to initiate continued multilateral dialogue among interested partners for sharing experiences and learning from each other. In this regard, as the initial step, the first “Asia-EU dialogue on nanosafety and nanoproduct certrification” event was organized by Iran Nanotechnology Initiative Council (INIC), co-organized by TAIEX, EU as well as Asia Nano Forum (ANF), on 28th Nov. 2017, in Tehran. The continuation of this event as a platform to bring closer both sides views and understanding promises the fruitful outcome for all engaged partners. 16
2nd EU-Asia Dialogue on Nanosafety
„The nano-bio interactions: from biological effects to
design by nanosafety”
Rong Cai
(National Center for Nanoscience and
Nanotechnology, Chinese Academy of Science)
Contact: cair@nanoctr.cn
Dr. Rong Cai is currently an assistant professor at the National Center of Nanoscience and
Technology (NCNST), Chinese Academy of Sciences (CAS). She received her Bachelor of
Materials Science and Engineering in 2008 from Beijing University Of Chemical Technology,
China, and her PhD of Materials Science and Engineering in 2015 from National Institute
for Materials Science (NIMS), Japan. Her research interests are mainly focused on the
understanding of biological effects of nanomaterials and nanosafety for nanobiomedical
applications. She was selected as the Youth member of Chinese Society of Toxicology In 2016.
She joined in the project of Analytical and Characterisation Excellence in nanomaterial risk
assessment: A tiered approach (ACEnano) from European Union Horizon 2020 Programme
(H2020).
Abstract:
After nanomaterials exposure to human body, nanomaterials interact with biomolecules
from biological fluids. A great amount of evidences have revealed that this natural “bio-
transformation” alters the biological effects of nanoparticles and is considered as an
important reason for different outcomes from in vitro to in vivo studies of nanoparticles. A
better understanding the dynamic protein corona and their subsequent biological effects is
critical for developing new strategies that improve the biosafety and efficacy of diagnostic and
therapeutic nanoparticles in clinics. We investigated the composition of protein corona bound
on widely used biomedical nanoparticles and characterized their impacts on cytotoxicity
and immunity. Based on the understanding of nano-bio interactions, new strategies can be
exploited to design efficacy and safe nanoparticles for biomedical applications.
172nd EU-Asia Dialogue on Nanosafety „Assessing the hazard of nanomaterials for humans with in vitro tools – how far we are and where to go” Barbara Rothen-Rutishauser (Adolphe Merkle Institute, Switzerland) Contact: barbara.rothen@unifr.ch Prof. Dr. Barbara Rothen-Rutishauser has received her Ph.D. in 1996 in cell biology at the Swiss Federal Institute of Technology (ETH) in Zurich. From 1996 to 2000 she held a post-doctoral position in Biopharmacy at the Institute of Pharmaceutical Sciences at the ETH and in 2000 she joined Prof. Peter Gehr’s research group at the University of Bern, Switzerland. B. Rothen- Rutishauser is an expert in the field of cell-nanoparticle interactions in the lung, with a special focus on 3D lung cell models and various microscopy techniques such as laser scanning and transmission electron microscopy. Since 2011 she is the new chair in BioNanomaterials at the Adolphe Merkle Institute, University of Fribourg, Switzerland, the position is shared equally with Prof. Alke Fink. The research group’s activities stretch over many fields from material synthesis and characterization to biological responses and hazard assessment. Prof. Rothen- Rutishauser has published more than 200 peer-reviewed papers and is an associate editor of the journal “Particle and Fibre Toxicology”. Abstract: Over the past decades the increase in nanomaterial research has resulted in an increase of nanotechnology related products for numerous applications, including medicine, consumer products (such as food additives, cosmetics and sporting equipment), environmental remediation and information technology. Humans can come in contact with nanomaterials in many different ways such as through the use of consumer products containing nanomaterials (i.e. food and cosmetic products), at the working place (i.e. occupational exposure), during disposal of the products (i.e. incineration) or by the intended use of nanomaterials in biomedical applications. Depending on the route of exposure nanomaterials may enter the human body via the lungs by inhalation, the gastro-intestinal tract by digestion, the skin, and blood vessels by intravenous injection. There is evidence that, depending on their physico-chemical properties and subsequent interactions, nanomaterials are indeed taken up by cells forming the various tissues / organs. However, their subsequent release and/or intracellular degradation of the materials, transfer 18
2nd EU-Asia Dialogue on Nanosafety
to other cells, and/or translocation across tissue barriers, is still poorly understood. The
involvement of these cellular clearance mechanisms strongly influences the long-term fate
of used nanomaterials, especially if one also considers repeated exposures.
In order to promote the safe-by-design approach, intensive research has been performed in
the past to determine if the potential benefits of nanotechnology could be utilized without
any adverse effects for human health. A plethora of experimental approaches have been
developed and are widely employed in conventional toxicological approaches. However,
the specific properties of nanomaterials such as smaller size but larger surface area, and
high catalytic reactivity and distinctive optical properties compared to their respective bulk
entities, often disable a straightforward use of established in vitro approaches. Herein, an
overview of the current state-of the art nanomaterial hazard assessment strategies using in
vitro approaches will be provided. In addition, the applicability of the approaches to translate
in vitro outcomes to leverage those of in vivo studies will be discussed.
192nd EU-Asia Dialogue on Nanosafety “Biokinetics of Co-exposed Nanomaterials” Il Je Yu (HCTm Aerosol and Toxicology Research Center, Korea) Contact: ijyu@hctm.co.kr Prof. Il Je Yu is a retired professor from Hoseo University, currently employed in the HCTm as director of HCTm Aerosol and Toxicology Research Center. He is a US board-certified toxicologist (DABT and EU-UK registered toxicologist) with more than 20 years of GLP environment experience with study director and facility manager. He is a certified industrial hygienist (CIH in US), certified safety professional (CSP in US) and registered quality assurance professional in GLP (RQAP-GLP in US) with responsibilities in multiple expertise area including environmental and occupational toxicology research, chemical safety assessment, inhalation toxicology, industrial hygiene research, GLP toxicology testing including new chemical registration, medical device testing, and new drug development, interaction with regulatory agencies, and education. Specific objectives include contributing to assessing risks of nanoparticles and hazard inhalants such as fumes, dusts, organic solvents and chemicals, managing research center and setting exposure limits and developing new occupational and environmental toxicology programs. He led 7 projects of international standard development in ISO TC 229 (Nanotechnology) and conducted several projects for OECD WPMN and for EU NanoREG. He also has been involved in developing WHO Guidelines on Nanomaterials and Workers’ Health and WHO/IPCS Environmental Health Criteria Document on Principles and Methods for assessing the risk of immunotoxicity associated with exposure to nanomaterials. He served as working group member for IARC monograph 93 and 111. In addition, his current works include developing methods of nanomaterial safety evaluation, exposure assessment, and health surveillance for workers in nanomaterial workplaces. Abstract: Information on toxicokinetics of nanomaterials including ADME (absorption, distribution, metabolism and elimination) is essential in understanding their behavior in vivo and also in their risk assessment. In real exposure situation, different types of nanomaterials can be exposed to workers and consumers. Toxicokinetic behavior of exposure to multi-nanomaterials would be different from single nanomaterial exposure. We have recently studied co-exposure of similar sizes of gold nanoparticles (AuNPs) and silver nanoparticles (AgNPs) via different routes of exposure such as intravenous and inhalation with administration of same concentration. 20
2nd EU-Asia Dialogue on Nanosafety
Upon AuNPs (12.8 nm) and AgNPs (10 nm) co-exposure by subacute intravenous injection
(28-days) and subsequent post-exposure observation (28-days), nanoparticle distribution was
decreased in these organs, suggesting a competitive cellular uptake and further confirming
that NP tissue distribution was in the particulate forms rather than in the ionic forms. Recent
subacute inhalation exposure (28-days) of similar size of AuNPs (10.8 nm) and AgNPs (10.8
nm) and subsequent post-exposure observation (28-days) revealed that inhalation exposure to
these particles showed a different toxicokinetic behavior from intravenous injection, showing
dissolution dependent clearance and distribution for AgNPs and particle size dependent
clearance and distribution for AuNPs. These two co-exposure studies suggested that route of
exposure and nanomaterial composition are major determinant for biokinetics of nanoparticles.
212nd EU-Asia Dialogue on Nanosafety “Realistic environmental exposure and ecological risk assessment” Claus Svendsen (Center for Ecology & Hydrology, United Kingdom) Contact: csv@ceh.ac.uk Claus Svendsen works on fundamental and applied environmental research at the NERC Centre for Ecology and Hydrology (UK) in Wallingford, where I lead their Ecotoxicology and Chemical Risk Group. I have authored or co-authored of over 100 papers and book chapters, and coordinated or been a WP leader or partner in many EU-funded projects on biomarkers, chemical mixtures and nano materials from FP4 – H2020, with other major funding from NERC (UK), EFSA and Defra (UK). Major research areas includes nanoecotoxicology, microplastics, comparative environmental genomics, bioavailability, and mixture toxicity. The overall focus being on how effects at the mechanistic levels translate into effects for populations and how organisms survive as populations in polluted habitats. For nanomaterials the current emphasis of our work is to address fate (transport, distribution and transformation), uptake and effects of exposure relevant (i.e. releases and environmentally processed/aged) nano materials and compare such results to those gained from “as produced” original nano materials. Abstract: Over the recent years it has become clear that ranking toxicities of nanomaterials through the testing of “pristine” as made particles in clean media may not provide much relevance in terms of the environmental risk their released forms potentially represents. While it is clear that dealing with detailed phys-chem characterisation of the multiple forms in which the nanomaterials may be released from all stages (particle production, incorporation, use and disposal phases) of a nano enabled products life-cycle is impossible. Then it is equally clear that adequate, realistic and efficient risk assessment cannot be done by simply comparing PNECs from “short lab test with pristine NM forms” with the PECs from mass flow based models that do not take the transformations of nanomaterials both pre and post release to the environment into account. For one the fate processes and behaviour of the released materials depend on the new phys-chem properties developed in such transformations. Again tracking such transformations in detail and doing so in environmentally relevant media and concentrations 22
2nd EU-Asia Dialogue on Nanosafety
is technically challenging and resource intensive beyond most available means. Therefore,
we propose to move focus away from the physical/chemical properties of pristine ENMs and
towards understanding the functional and behaviour patterns of release relevant ENMs in
exposure relevant environments. The need for this has been highlighted through a series of
recent non-standard experiments aimed at delivering as relevant nanomaterial exposures as
possible and comparing this with “pristine NM exposures”. Through these experiments we will
show how presenting an exposure into a system as nano vs ionic metals lead to diverse and in
some cases unexplainable response patterns. The presentation will outline the vision of the
NanoFASE project and the exposure knowledge it will build and how we envisage this being
linked to ecotoxicological knowledge and the data collaboration challenged we face to do this
and our proposed solution, which is open to collaboration with any environmental exposure
and ecotox projects or initiatives interested in joining forces here.
The outline will cover the main aims and outputs of NanoFASE including developing a catalogue
of options to supplement the current mainly mass-based lifecycle and release flow approaches
to enable spatial and temporal variability of ENM release, environmental transport and fate
to be included in exposure modelling and assessment. The framework, will incorporate (i) the
behaviour of the actual relevant ENM forms released from ENM products; (ii) how reactions
in waste management and environmental compartments transform such release-relevant
ENMs; and (iii) the consequences of these transformations for transport and fate and among
the different environmental compartments including organism uptake.
232nd EU-Asia Dialogue on Nanosafety „Nano-safety & Standardization Initiative in Thailand” Ramjitti Indaraprasirt (Nanotec Thailand) Contact: ramjitti@nanotec.or.th Education: Master in International Administration Program in Intercultural Management, School for International Training, Brattleboro, Vermont, USA (1991) Professional career: October 1, 2015 – present Manager, Nanosafety Alliance Section, National Nanotechnology Center (NANOTEC), National Science and Techno logy Development Agency (NSTDA) May 2010 – September 2015 Manager, Public Relations Section, National Nanotechnology Center (NANOTEC), National Science and Technology Develop ment Agency (NSTDA) 2004 – May 2010 Head of Public Relations Section, National Center for Genetic En gineering and Biotechnology (BIOTEC), National Science and Technology Development Agency (NSTDA) 1992 – 2004 Business Development Manager, Pac Rim Internat. Co., Ltd. 1992 – 1998 Program Manager, Canadian Executive Service Organization (CESO) Abstract: Nanotechnology in Thailand has been around for about 20 years. In the early stages nanotechnology was introduced to the public in the form of imported products. As these products began to make their way to Thai society in mass, the government felt it was necessary to build knowledge of nanotechnology, hence NANOTEC was established on 13 August 2003. Discussion on nanosafety and ethics only began in 2009 when it was decided that there was a need to incorporate and develop a form of strategic plan in the national nanotechnology plan. The first National Nanosafety and Ethics Strategic Plan was approved in 2012 and the plan was for 5 years. Since then the 2nd plan has been renewed in late 2016 and approved in early 2017. The current plan will from 2017-2021. Interest in standardization related to nanotechnology soon followed with a joint effort with Thai Industrial Standards Institute (TISI) to work on 7 industrial standards manuals which was eventually approved in 2014. The talk will focus on the various initiatives that NANOTEC is implementing to address the topic of nanosafety and standardization in Thailand. 24
2nd EU-Asia Dialogue on Nanosafety
“Safety Assessment of Nanomaterials using
Alternative Methods”
Rawiwan Maniratanachote (Nanotec Thailand)
Contact: rawiwan@nanotec.or.th
Rawiwan Maniratanachote has scientific backgrounds in pharmacology, drug metabolism in
cytochrome P450 system, toxicology, molecular biology and biochemistry. She obtained her
BSc. in Pharmacy and MSc. (Pharmacology) from Chulalongkorn University, Thailand, and
received her Ph.D. (Toxicology) from Kanazawa University, Japan, where she also attended
postdoctoral fellowship for one and a half years. In 2008, she was a guest scientist at EMPA
Material Science and Technology, St. Gallen, Switzerland to analyze special techniques on
nanotoxicology researches.
Currently, Rawiwan is a senior research scientist and head of Nano Safety and Risk Assessment
Laboratory (SRA) at National Nanotechnology Center (NANOTEC), a member of the National
Science and Technology Development Agency (NSTDA) under the Ministry of Science and
Technology. She has 11-year experience on management of SRA research team, supervising
researches on nanotoxicology, developing high impact research projects to support industrial
sectors, and being an invited lecturer at universities in Thailand. Her main research interests
are in the area of investigation and classification of nanomaterials toxicity and safety of
nanoproducts on human health and the environment. She is also actively involved in “NanoQ
project” as a technical committee of the Nanotechnology Association of Thailand.
Abstract:
Nanotechnology is a rapidly growing area of research and development in various industrial
sectors. The utilization of nanomaterials can be ubiquitously found in products including
electronics, household items, medical devices, food and cosmetics. Thus, public safety of
different nanomaterials is an important concern. Reliable toxicological testing models and
methods are required to gain insightful and thorough understanding of how the particles interact
and potentially cause adverse effects to human health and the environment. We are currently in
the stage of moving forward in the area of humane science by reduce, refine and replacement of
animals, knowing as the 3Rs principle, in the research and development of consumer products.
Meanwhile, the use of animals for toxicity testing has begun to fade out as alternative methods
are increasingly developed and validated, which are also useful in the field of nanotoxicology.
This talk will highlight in vitro models of cells, human tissues and microorganisms, as well as in
silico models for investigating effects ofmetal-based nanomaterials on human health and the
environment.
252nd EU-Asia Dialogue on Nanosafety
“Malta Initiative – a joint approach to adopt
the OECD TG to the needs of nanomaterials”
Anke Jesse
(Federal Ministry for the Environment,
Nature Conservation and Nuclear Safety, Germany)
Contact: +49 (0)30 18 305-2128; E-Mail: anke.jesse@bmu.bund.de
Since Dec 2008: Head of Division “Nanotechnology and Synthetic Nanomaterials” at the
Federal Ministry for the Environment, Nature Conservation and Nuclear
Safety
2005-2008: Head of Division “Cabinet and Parliament” at the Federal Ministry for the
Environment, Nature Conservation and Nuclear Safety
2003: Head of the Representation of North Rhine-Westphalia to the Federation,
Berlin
2001-2003: Head of Minister’s Office at the Finance Ministry of North Rhine-West-
phalia, Düsseldorf
1998-2001: Member of the Landtag, Düsseldorf
1994-1998: Department head in Detmold district government, (Ministry for the
Interior of North Rhine-Westphalia, Düsseldorf)
1994 : Head of legal department of the re-established Erfurt University
(Ministry for Science and Art, Free State of Thuringia)
Abstract:
Since the 1970s, the OECD has facilitated the development of harmonized test guidelines and
tools to assess chemical safety and has also developed principles of Good Laboratory Practice
(GLP). This work has been the foundation for generating high quality and reliable data on
the hazards of chemicals on the market. This not only improved the understanding of safe
manufacturing and use of chemicals at a global level, thus contributing to numerous sustainable
development goals; but it has also offered benefits to both governments and industry, allowing
the use of commonly accepted test guidelines and tools. In particular because these are coupled
with the very important OECD agreement on Mutual Acceptance of Data (MAD), which is
underpinned by a number of OECD legal instruments and that facilitates and streamlines data
generation and acceptance among the adhering countries.
262nd EU-Asia Dialogue on Nanosafety
Today, this is the lock and key for chemical management and underpins the majority of all
chemical regulations currently enforced. It has also prevented many times a duplication of
tests which has not only a positive financial aspect such as reducing artificial trade barriers, but
also actively limits the need to use animals in hazard/risk assessment of chemicals. The growing
membership of the OECD indicates that this is the right track in implementing sustainable
chemicals management globally.
As described above, OECD test guidelines are an important corner stone for the realisation
of regulatory requirements. Therefore, the adaptation of test methods to the specificities of
nanomaterials is not a goal in itself but is one crucial building block to make chemicals legislation
fit for nanomaterials.
In 2017, a new action the Malta Initiative was initiated under the umbrella of the European
Commission together with European countries and industry. The purpose was to increase
the EU contribution to the development of nano specific OECD test guidelines and guidance
documents. In particular, efforts should be made in harvesting in a systematic manner the
relevant knowledge and methods gathered in research projects (including those of the EU
nanosafety cluster) and develop and validate OECD standards.
With this in mind, Germany has led an initiative called the Malta Initiative, together with
a number of EU countries, industry, as well as EU institutions such as JRC and ECHA. The
objective is to assess the deliverables from EU and MS research projects, distil knowledge and
methods that are useful to revise existing or develop new OECD test guidelines and guidance
documents where necessary. This initiative is open for participation and needs contributions by
all OECD WPMN delegations, hence it is explicitly not an activity to be exclusively performed
by EU member states. In this spirit the Malta Project will be an integral part of the OECD work
on chemicals management.
272nd EU-Asia Dialogue on Nanosafety “caLIBRAte – Creating a Web-based HUB for tested Tools for Governance of Emerging and Existing NanoRisks” Keld A. Jensen (National Research Centre for the Working Environment, Denmark) Contact: kaj@nrcwe.dk Dr. Keld Alstrup Jensen is employed at the National Research Centre for the Working Environment (NRCWE), Copenhagen, Denmark. He obtained his PhD degree in 1999 from the University of Aarhus, Denmark and spend 1½ year post.doc. period at the University of Michigan, USA before starting his current career at NRCWE in September 2000. His research focuses on materials and methods for substance identification, grouping and biological interaction and fate testing, occupational exposure measurement and assessment, and tool- development for control banding and risk management (www.nanosafer.org). He currently coordinates the EU H2020 Project caLIBRAte (www.nanocalibrate.eu) on the next generation risk governance framework. He has served as Work-Package leader or participant in several EU- funded projects (e.g. ENPRA, NANODEVICE, NANOSUSTAIN, NANOGENOTOX, NANOREG, and SUN) and now in the EU H2020 projects: EC4SAFENANO, NanoReg2 and PATROLS. He contributes to standardization work and is Leader of the Danish Standard working Group S-418 on Nanotechnology as well CEN standardization project CEN/TC 352/WG 1/PG 2 and contributor to CEN/TC 137/WG3. He currently has more than 80 peer-reviewed scientific publications and an ISI web of Science H-factor of 31 and an average citation rate of 32.37 Abstract: There is high commercial interest and drive towards development and use of manufactured nanomaterials (MN). However, obstacles may arise in association with launch of new MN or new uses of MN in products due to a general uncertainty regarding their associated potential human and environmental risks. This is in part due to the fact that current regulatory risk assessment methods are either not suited or not validated for assessment of MN and MN-enabled products. This may result in apparent or perceived risks and uncertainties about how to manage the risks. Problems related to safety assessments of MN and MN-enabled products may be significantly reduced if results from nanospecific safety analyses are taken into consideration during and NM and product development. 28
2nd EU-Asia Dialogue on Nanosafety
The caLIBRAte project strives towards identifying a series of suitable control banding and risk
assessment models to support safety assessment of for MN and MN-enabled products during
innovation and use and aligned with stakeholder needs and competences. Selected models
are thoroughly tested and demonstrated and become members of a web-based “system-of-
systems” (SoS) risk governance framework. When complete, the framework is anticipated to
contain tools for: 1) horizon scanning with screening of a.o. various material and hazard trends
in nanotechnology; 2) control banding, qualitative and fully integrated predictive quantitative
risk assessment operational at different information levels; 3) safety-by-design by link to the
NanoReg 2 safety-by-design platforms 4) decision support; and 5) guidance for risk surveillance,
and -management.
Now past 2 years into the 3.5 years project duration, key results start to emerge and the
System-of-Systems framework starts to take shape. Human and environmental candidate
risk assessment models have been identified and data on MN properties, MN hazards, and
MN exposures are being gathered. Next generation risk assessment methods are under
development and will include use of high-throughput testing and genomics data. Sensitivity
testing has revealed interesting differences in the most and least determinant input parameters
in the existing control banding and risk assessment tools. The next step involves performance
testing of the models using existing hazard and exposure measurement data collated into data
libraries for performance testing. Supporting analytical and toxicological studies are being
completed to fill key data gaps and investigating the role of the surface area paradigm as well
as effects of doping, coating and functionalization are in process. First comprehensive industrial
case-studies have also been established, including completion of a unique indoor and outdoor
measurement field campaign at a paint producer. Case-studies will be used to demonstrate the
risk governance framework at the end of the project.
This presentation will give an introduction to the caLIBRAte project and the current status of
the caLIBRAte risk governance framework with information on stakeholder needs and snaps-
hots of lessons learned from interim model sensitivity and performance testing results.
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