Intergovernmental Forum on Chemical Safety Global Partnerships for Chemical Safety Contributing to the 2020 Goal ABSTRACTS Nanotechnology and nanomaterials: opportunities and challenges ROOM DOCUMENT List of Contents General Introduction: Nanotechnology and nanomaterials: opportunities and challenges Georg Karlarganis, Federal Office for the Environment (FOEN), Switzerland Nanotechnology: what is it? Germ Visser, DSM Innovation Center, The Netherlands Health effects of free engineered nanoparticles – an evolutionary perspective C. Vyvyan Howard, University of Ulster, United Kingdom The interaction of manufacture nanomaterials with our organism – example lung Peter Gehr, University of Bern, Switzerland Occupational Health and Safety: possible challenges and risks for workers Pieter van Broekhuizen, University of Amsterdam, Holland Little BANG theory (Bits, Atoms, Neurons and Genes): The socioeconomic impact of technological convergence at the nanoscale Pat Mooney, ETC Group, Canada Nanotechnologies – new technological hype with uncertain consequences for society? How choices of technologies impact on the development of society Claudia Neubauer, Citizen Sciences Foundation, France Nano-Divide: a question of justice? Andreas Bachmann, ethic im diskurs, Switzerland Nanotechnologies at the OECD Rob Visser, OECD, Paris, France International standardization – supporting safe and successful nanotechnologies for all stakeholders Peter Hatto, Chairman ISO/TC 229 – Nanotechnologies, IONBond Ltd., United Kingdom Intergovernmental dialogue on nanotechnologies: The case of the OECD Working Group on Nanotechnology Francoise Roure, Vice-President of the OECD Working Group on Nanotechnology Nanotechnology and manufactured nanomaterials – ongoing and planned work in the UK Jane Stratford, Department for Environment Food & Rural Affairs, UK NanoSafety in Thailand Lerson Tanasugarn, Chulalongkorn University, Thailand Status of Nanotechnology in Nigeria: Prospects, Options and Challenges Olusegun O. Adewoye, NASENI, Nigeria History and current status of Nanotechnology in Russia. Contribution to global dialog on EHS issues Marine Melkonyan, , A.V. Shubnikov Institute of Crystallography of RAS, 2 Moscow, Russia Current Status and Perspectives of the Nanotoxicity Research in Korea Kyung-Hee Choi, Ministry of Environment, Republic of Korea The small and the risk – a view from the re/insurance industry Thomas Epprecht, Swiss Reinsurance Company. Role of National Nanotechnology Center (NAOTEC) and the Code of Conduct for Responsible Nanotechnology in Thailand Noppawan Tanpipat, National Nanotechnology Center, Thailand Nanotechnology in a Developing Country – applications and challenges Babajide I. Alo, University of Lagos, Nigeria 3 Nanotechnology and nanomaterials: opportunities and challenges General Introduction Dr Georg Karlaganis, Head of the Substances, Soil, Biotechnology Division Federal Office for the Environment (FOEN) Switzerland Nanotechnology is a rapidly emerging technological approach that is expected to result in major changes across many industry sectors. This may bring many advances to society and benefits for the environment, but also poses new challenges, especially in health and safety. To date discussions on the potential benefits of nanotechnology have, for the most part, taken place separately from those on the potential risks to human health and the environment of nanomaterials. Such discussions should take place concurrently. As a result of nanotechnology’s rapidly burgeoning growth, it is important that all stakeholders concerned (governments, international, regional and national organizations, industry groups, public interest associations, labour organizations, scientific associations and civil society) engage in discussions to identify and address issues that may impact health and safety in positive or negative ways. The objective of the plenary session will be to exchange information in order to help raise the awareness of participants to the potential new opportunities, the new challenges and the new hazards and risks posed by nanotechnology. The meeting will provide a forum to share information on known and emerging issues, on the work of the OECD and ISO on nanotechnology and to foster an understanding of issues (applications and implications). The Forum will also be an opportunity to discuss the potential contributions of nanotechnology to sustainable development and to discuss how to achieve an equitable distribution of benefits and risks and role of responsible stewardship in addressing nanotechnology. Governments around the world are looking at the new opportunities offered by nanotechnology and are keen to understand, avoid, reduce and manage risks associated with this new technology and nanomaterials. To facilitate this process a draft Dakar Declaration on nanotechnology and manufactured nanomaterials is presented by the lead sponsor to the Forum for its consideration. *** Documents for the session are: - Thought Starter, Nanotechnology and manufactured Nanomaterials: Opportunities and Challenges, Prepared by: FSC Working Group, lead sponsor Switzerland (IFCS/FORUM-VI/01.TS) - Nanotechnologies at the OECD, Prepared by: OECD (IFCS/FORUM-VI/4 INF) - Activities on Nanotechnologies in the IOMC Organizations, Prepared by: OECD Secretariat at the request of the IOMC (IFCS/FORUM-VI/5 INF) - an overview of the work of ISO on nanotechnology and manufactured nanomaterials (IFCS/FORUM-VI/6 INF) 4 Nanotechnology: what is it? Germ W. Visser, DSM Innovation Center - CTO, The Netherlands. Nanotechnology will be explained from the perspective of a multi-specialty chemical company. Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM’s products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrics and electronics, life protection and housing. DSM has annual sales of almost EUR 8.8 billion and employs some 23,000 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. With the general theme of its strategy “Vision 2010: Building on Strengths” DSM expresses the intention to maximally exploit the potential opened up by the successful transformation of the company during the preceding strategic period. Innovation is one of the main accelerators for the growth of the company in targeted areas. Mega societal and technological trends in the world are the key drivers for the development of new products and concepts at DSM. For future applications in different sectors advanced materials are a decisive factor. A technological drive of crucial importance for the development of smart materials is the convergence of biotechnology and nanotechnology. Examples of such developments at DSM and elsewhere will be presented next to every day and historical nanomaterials. Their social and environmental utility will be discussed. All new technologies including nanotechnologies do include potential risks that need to be managed. Nanotechnologies are a collection of various very diverse technologies and their risk cannot be approached as such. A more specific risk assessment in function of the applications is needed. Risk is a function of hazard and exposure and some categories of individuals are more at risk for effects of nanomaterials than others. Proper risk assessment is hampered by a lack of data. The lack of standards for characterization, evaluation of toxicology and occupational health (both assessment and protection) makes it difficult to develop knowledge about toxicological aspects of nanomaterials. At present many different organizations are trying to close the gaps. A global concerted and well orchestrated action is needed to answer the many questions that are emerging. Besides the technical approach there is also the perception of people. This factor needs to be addressed in the proper way as it will be public acceptance that will make or break the applications of nanotechnologies. 5 Health effects of free engineered nanoparticles – an evolutionary perspective Prof. C. Vyvyan Howard University of Ulster, UK We have always been exposed to nano-particles, mainly consisting marine aerosol, minute crystals of soluble salts windblown from waves in the sea. However, there were relatively few other inorganic nano-particles of less than 100 nm in the air throughout our prehistory. The main biological nanoparticles were viruses and some other biological particles. That changed when man harnessed fire about 100,000 years ago and combustion nanoparticles became a common part of man’s environment. Our defence mechanisms against nanoparticles evolved principally to cope with the biological threat posed by viruses There is evidence that nano-particles can gain entry to the body by a number of routes, including inhalation, ingestion and across the skin, and can then travel around the body into various organs, including across the blood-brain barrier (Gumbleton, 2001). These properties are being positively harnessed by the pharmaceutical industry to improve the efficiency of drug delivery, and there is now growing recognition that the same properties could apply to ‘uninvited’ nano-particles resulting from pollution or manufactured products. It has been shown that insoluble nano-particles can be toxic and therefore potentially hazardous (Oberdorster, 2000). Nano-particles have a potential for toxicity that appears to be related primarily to their small size rather than to the type of material from which they are made, although there is still much research to be done before this question is fully understood. The upper size limit at which the toxicity associated with nanoparticles ceases is not fully known but is thought to lie between 65 and 200 nm. One area of concern that is, as yet, under researched is the ability of nanoparticles to cause protein misfolding (e.g. Bilsten et al, 1997 ) There is epidemiological evidence showing that exposure to particulate aerosols leads to long term health effects, primarily of the cardio-pulmonary system (e.g. Wichmann and Peters, 2000). There is also evidence that short term effects from poor air quality is due to particle overloading. Enough evidence is already extant to demonstrate that nano-particles are likely to pose a health hazard and that human exposure in general, and in particular in the workplace, should be minimised on a precautionary basis. A number of expert working groups have met under the auspices of the EU and it appears that there will be new legislation considered in the near future (http://europa.eu.int/comm/health/ph_risk/events_risk_en.htm). The insurance industry is also taking a keen interest. While it is easy to appreciate how nanotechnology is being harnessed to positive uses in the pharmaceutical, electronic, food and water industries uses, there is an urgent need to control and minimise the generation of unnecessary nano-particles, particularly of the insoluble variety, in the ambient environment. For example there are early indications that some types of carbon nanotube can mimic asbestos and induce mesothelial tumours (Takagi et al, 2008). The last thing that society should wish to do is to leave a long term negative legacy for future generations As far as can be determined, the risk assessments to address the misgivings outlined above are not yet in place. It seems important that the long term environmental fate of such products be determined before mass production proceeds. We must act on a precautionary basis. Bilsten et al (1997). FEBS Lett 402: 67-72. 6 Gumbleton M (2001) Advanced Drug Delivery Reviews 49: 281–300 Oberdorster G. (2000). Phil. Trans. R. Soc. Lond. 358: 2719-2740. Takagi A, Hirose A, Nishimura T, et al. (2008). J. Toxicol. Sci. 33: 105-116. Wichmann, H.E., and Peters, A. (2000). Phil. Trans. Roy. Soc. Lond. 358: 2751-2769. 7 The interaction of manufactured nanomaterials with our organism – example lung Peter Gehr, Ph.D., Professor and Chair, Institute of Anatomy, University of Bern, Bern, Switzerland Progressively more nanoparticles, defined as manufactured structures of ≤100 nanometers size, are released into air, water and soil every year from different sources, including nanotechnology. The human health benefits of nanotechnology are undoubted, however, occupational exposure, direct human exposure through medical applications and ambient air pollution may, depending on the dose and particle characteristics, cause adverse health effects. The environment is affected similarly. Most toxicity research so far has been carried out with mammals, mainly focusing on the respiratory system, but also with other animals, like e.g. fish and daphnia as well as with plants and, last but not least and most importantly, also with cell culture models. Let us focus on human exposure by inhalation, in order to explain the mechanisms of adverse effects nanoparticles may have. A huge internal pulmonary surface area of 150 m2 in humans with a minimal air-blood tissue barrier of <1 µm is available for the interaction with inhaled particles. It has been found that nanoparticles, not larger particles, can cross the air-blood tissue barrier and enter the blood capillaries. Scientists have shown that exposure to combustion-derived ultra fine particles can be associated with pulmonary and cardiovascular diseases. The mechanisms are believed to include oxidative stress and inflammatory reactions in cells. We have found with inhalation experiments in whole animals and with in vitro studies in cell cultures using different types of manufactured nanoparticles a transport mechanism that includes a non-specific penetration of particles into cells by adhesive interactions. We were able to show that nanoparticles may cross the air-blood tissue barrier in a directed way entering the capillary blood. From there the nanoparticles can be translocated to other organs. The adverse potential of nanoparticles is greatly enhanced by their free location and movement within cells. Nanoparticles may be found in mitochondria and the nucleus suggesting toxic and carcinogenic potential. Thus, nanotechnology and its use in many applications have the potential to induce a spectrum of human health and environmental hazards. Because we still know little about the mechanisms of the development of such hazards, toxicological studies and regulations are essential before the large scale industrial production of nanoparticles occurs. 8 Occupational Health and Safety: possible challenges and risks for workers Pieter van Broekhuizen, University of Amsterdam, Holland Hundreds of consumer and manufactured products containing engineered nanomaterials or made with the use of nanomaterials are already on the market. Quite a lot of these products, as well as their base materials are been made today and placed on the market without thoroughly knowing whether nanomaterials are released from them and what their potential impacts on human health and the environment may be. Workers all along the production chain from laboratories through to manufacturing, transport, shop shelves, cleaning, maintenance and waste management may be exposed to these new materials. Nevertheless it is unknown whether the safety procedures implemented are adequate or the protection measures applied are sufficient. In many cases they are even uninformed about the potential risks, simply because the risks are still unknown. As a consequence nanoparticles are discharged and disseminated out into the open without knowing what the consequences may be and up till now without effective ways of detecting and measuring them. Workers engaged in research, development, manufacture, packaging, handling, transport, use and elimination of nanomaterials and nanotechnology products will be most exposed, and therefore most at risk of any harmful effects. Therefore a precautionary approach to secure the health and safety at work must have priority in any nanomaterials surveillance system. There is a great need for training, education and research in order to allow health and safety specialists (e.g. labour inspectors, preventive services, occupational hygienists, company physicians) preventing known and potential exposures to nanomaterials that have not been proven safe. In spite of the fact that there are still many gaps in knowledge required to make a responsible risk assessment and design a safe workplace, there are already many tools that may be applied to go for a worst case, precautionary approach. These tools can be found in “traditional” risk assessment and the development of occupational exposure limits by adapting these systems to the nanoscale. Furthermore it is identified that requirements formulated under the new REACH regulations can be applied to the materials on the nanoscale, and that an adaptation of some premises in REACH, especially concerning the data requirement and obligation to make chemical safety reports for intended use of chemicals, may provide excellent opportunities for a responsible precautionary nanoapproach. 9 Little BANG theory (Bits, Atoms, Neurons and Genes): The socioeconomic impact of technological convergence at the nanoscale Pat Mooney, Executive Director, ETC Group (Canada) From Brussels to Beijing, science policy makers are talking about technological convergence (the coming together of biology, chemistry, and physics) at the nanoscale. While this technological convergence offers enormous opportunities for the improvement of environmental quality, energy efficiency, water and other natural resource maximization, etc., it also poses substantial threats to commodity export-dependent developing countries. At this early stage in the development of nanoscale technologies it is difficult to know either the quantities or the types of raw materials that may be required. It's equally difficult to predict potential changes in economic structures and regulatory arrangements. Since most of the intergovernmental dialogue related to nanotechnology and technological convergence tend toward the optimistic (if not euphoric) end of the opportunities/risk spectrum, I will focus on risk elements that I believe have not been given adequate consideration. There are lessons from the history of technology introduction that may be useful in guiding country-level planning. First, we must recognize that new technological waves are not a "force of nature" but manufactured processes. Economic interests suppress some technological opportunities in order to advance others depending upon their perceived needs at the time. It is as important to consider what is suppressed as it is to consider what is promulgated. Secondly, it seems to take a human generation to fully comprehend the wider environmental and socioeconomic implications of a new technology. Early projections (for good or ill) are almost always wrong. Thirdly, (and this is becoming increasingly the case) venture capital exigencies tend to push new technologies into the marketplace before they are perfected -- leading to problematic health, environmental, and social conditions. Fourth, once introduced, new technologies are extremely difficult to recall if they are found to be dangerous. With rare exceptions, technologies or specific products are only withdrawn after the introducing industries have exploited the lifecycle of their production system and have found a commercially-profitable alternative. Fifthly, because technological waves are manufactured, marginalized countries and people rarely see the wave coming and are swamped in its trough for at least a generation. Although new technologies portend break-throughs and talk of leapfrogging over old technologies onto new scientific platforms, the socioeconomic environment within which the new technology is introduced is likely to determine who benefits. In general, major technologies introduced into an inequitable society will (initially) exacerbate the gap between the rich and the marginalized. It is not simply that the rich get richer for the first few decades or generations but the poor get poorer. Finally, new technologies do not need to be scientifically successful in order to be commercially profitable. Governments and society need only be persuaded of the inevitability and potentiality of the new technology in order for it to displace other technologies and for its owners to make demands of the socioeconomic system. Although there is much talk about technological convergence there is less recognition that technological convergence invites corporate concentration and may require protective regulations and greater convergence between public and private sector science. While we struggle to understand the impact of new technologies on commodities and markets, we must also consider the potential for this convergence to evolve patent regimes that allow for multi-sector industrial monopolies and a new round of mergers and acquisitions -- or alliances -- that could give unprecedented control to new economic actors. There is an urgent need to monitor intellectual property and other competition policy regulations. There's also an urgent need to begin the long process of creating an International Convention for the Evaluation of New Technologies (ICENT). 10 Nanotechnolgies – new technological hype with uncertain consequences for society? How choices of technologies impact on the development of society. Dr. Claudia Neubauer, Citizen Sciences Foundation, France In the last two centuries, synthetic chemicals have been deeply transforming the world. Nowadays, products at nano scale present radically new properties leading to numerous new applications but also to new and probably unexpected risks and consequences - for human health, for the environment and for our societies at large. Nanosciences and nanotechnologies (NST) present a sector of intense international competition and pretend to impose a scientific and technological (r)evolution impacting on every domain of social life. But like all scientific knowledge and modern technologies, they are situated in concret social, political and historical contexts, involve many substantive social, political, economic and cultural transformations and affect social and political structures throughout a society. Technoscientific knowledge is not neutral nor are the conditions of its production or the visions of a future society it is transmitting. However, technology policies often escape public scrutiny. Nowadays, the principal scientific and technological choices are influenced by market, researchers and bureaucrats, and decisions are often made outside the operational framework of our democracies. NST are part of a dominant political discours that proposes technical fixes for social problems, reduces public research to a subcontractor of economic competitiveness and growth, strengthens private intellectual property rights and promotes high-tech solutions as sources of employment, security and happiness. Nevertheless, a new form of social conflictuality centred on the questions of risk has arisen since society has been confronted with numerous unintended, the environmental and human life threatening consequences of scientific and technological innovations. Doesn't this situation confirm that technologies and competitiveness cannot compensate for the lack of just social and environmental policies ? Doesn't it confirm that these technologies are not shaped to solve long lasting injustices in society and that conceiving public science policy in a solely industrial and commercial framework is unjust and incommensurate ? Technosciences, especially NST, and more widely converging technologies, oblige us to question the very basis sense of research, innovation, progress and societal development. We are increasingly conscious that we live in a limited world, on a planet where the natural capital becomes a limiting factor. The needs of the most underprivileged, the concerns of social and environmental justice, solidarity, diversity, sustainability, human rights, alternative property schemes and the public request for knowledge to manage our world more wisely must thus be integrated with research and innovation. Rethinking innovation for human needs and democratising scientific and technical choices are more relevant than ever before. 11 Nano-Divide: a question of justice? Andreas Bachmann, ethic im diskurs, Switzerland It is generally agreed that nanotechnologies are likely to have considerable effects on economies and societies worldwide. However, how will these effects be distributed? Some claim that the distribution will be extremely unequal. They fear that particularly the developing countries may not benefit from the achievements of nanotechnologies – just as they have not benefited from other technological achievements. As a result, the technology gap between the poor and the rich may widen even further. Plausible though it may seem, it remains to be seen whether this thesis of ‘nano-divide’ proves correct. This is an empirical question. From an ethical point of view, what is relevant is the normative question whether the unequal distribution of (or access to) nanotechnological products between developed and developing countries would be unfair or unjust. The answer will be: it depends. It would be unjust, for instance, if nanotechnological products – such as water filtration systems using carbon nanotubes – that, once they exist, could help meet basic needs such as the need for clean drinking water were inaccessible to those in need because they are too expensive. The reason would be that every human being has the same justified claim to have his or her basic needs fulfilled. Justice here implies strict equality - and a corresponding moral duty to see to it that this equality is guaranteed. It would not be unjust, however, if nanotechnological products – such as sunscreens containing nanoscale titanium dioxide for better UV-protection or computers containing nanoscale transistors – that are not necessary for survival or a minimally decent life turned out to be too costly to people in the developing world (or, for that matter, to poor people in the developed world). In its report on nanotechnology the UNESCO emphasizes that the patenting system may turn out to be an almost insurmountable obstacle for developing nations with regard to nanotechnological R&D: “The danger created by excessive patenting in nanotechnology is that of the ‘patent thicket’ (…). Patents on basic nanoparticles and processes using nanoparticles could end up being so finely and acutely propertized that the ability to create a novel material [such as a water filtration system] could face nearly unnavigable complexity in terms of competing and overlapping patent claims” (UNESCO (2006), The Ethics and Politics of Nanotechnolgy, p.18). This kind of ‘excessive patenting’ in nanotechnology may have two negative effects on developing nations: 1) Nanotechnological research in developing nations may not be able to compete with research in developed nations. As a consequence these nations cannot develop products such as nano-based water filtration systems that are needed in order to meet the basic needs of their population. They completely depend on those who do have the means to develop products of this kind. 2) These products, however, may be too expensive for the poor, not least because of licensing fees due to patents. 12 If something like this happened it would bring about a ‘nano-divide’ that would be unjust. How can this injustice be avoided? According to UNESCO one viable option is: “To encourage – and amongst national governments, to require – open access to publicly funded research results and materials”. One could even go one step further and demand open access to privately funded research results as well - analogously to the “Free and Open Source Software” that led to the development of the computer system Gnu/Linux. Whether and how this option can be realized without generating new injustices remains to be seen. 13 Nanotechnologies at the OECD Rob Visser, OECD, Paris, France The OECD has two programmes related to nanotechnologies: i) the activities of the Working Party on Manufactured Nanomaterials; and ii) the Working Party on Nanotechnology. These co-ordinated and mutually supportive efforts are intended to provide the conditions for optimal safe development of this range of new technologies. The main focus of this presentation will be on the activities of the Working Party on Manufactured Nanomaterials (WPMN) which was established in 2006 as part of OECD’s Environment, Health and Safety Programme. The objective of the WPMN is to promote international co-operation in human health and environmental safety related aspects of manufactured nanomaterials, in order to assist in the development of rigorous safety evaluation of nanomaterials. The work is being implemented through eight projects: Development of a Database on Human Health and Environmental Safety Research; Research Strategies on Manufactured Nanomaterials; Safety Testing of a Representative Set of Manufactured Nanomaterials; Manufactured Nanomaterials and Test Guidelines; Co-operation on Voluntary Schemes and Regulatory Programmes; Co-operation on Risk Assessment; The role of Alternative Methods in Nanotoxicology Exposure Measurement and Exposure Mitigation The safety of nanotechnologies is a global issue and consequently the need to meet environmental and health safety objectives goes beyond OECD member countries. For this reason, the WPMN is increasingly involving the participation of non-member economies (to date, Brazil, China, the Russian Federation, Singapore and Thailand). There is also strong communication with other international organizations such as the other IOMC participating organizations (FAO, ILO, UNEP, UNIDO, UNITAR and WHO) as well as UNESCO and ISO. The work benefits also from the inputs of BIAC (the Business and Industry Advisory Committee to OECD), TUAC (the Trade Union Advisory Committee to OECD) and Environmental NGO’s. Detailed information can be found at: http://www.oecd.org/env/nanosafety/ 14 International standardization - supporting safe and successful nanotechnologies for all stakeholders Dr Peter Hatto, Chairman ISO/TC 229 – Nanotechnologies, IONBond Ltd., UK By providing agreed ways of naming, describing and specifying things, measuring and testing things, managing and reporting things, written, consensual standards support commercialisation and market development, provide a technical, quality and environmental basis for procurement, and support the development and introduction of appropriate legislation and regulation. The provision of a comprehensive standards infrastructure for nanotechnologies, covering terminology and definitions, measurement and characterization, and health and environmental safety, including protocols for risk and life cycle assessment, is seen as essential to their commercial success. With such an infrastructure in place, industry will be able to focus on producing innovative products in the knowledge that they have the tools available to assure quality and evaluate and mitigate hazards and risks, consumers will be able to have confidence in the efficacy and safety of nanotechnology products, and regulatory agencies will have the necessary technical support for the development of appropriate regulation. ISO/TC 229 has a dynamic work programme, committee structure, and comprehensive standards development road map that will address these three areas – terminology, measurement and characterization, and health and environmental safety, together with (nano)materials specifications. The committee’s work is coordinated with that of several ISO TCs and other relevant international organisations whose own work has an impact on, or is impacted by, nanotechnologies. This cooperation will help to ensure the delivery of harmonized outputs relevant to the needs of all stakeholders. 15 Intergovernmental dialogue on nanotechnologies: The case of the OECD Working Group on nanotechnology Francoise Roure, Vice-President of the OECD Working Group on Nanotechnology Nanotechnology is an emerging technology that has the potential to bring major changes in many fields of application. The limits of the use of nanotechnologies as well as their social use need the adoption of a normative and dynamic approach that applies directly to the governments. The socio-economic perspectives and the potential responses of nanotechnologies to the big challenges of the millennium deserve to be apprehended in a balanced way by defining in a cooperative framework the responsible, balanced and appropriate policies that take into account the true value of the environmental, ethical and public health aspects. The public policies related to nanotechnology need to rely on a dynamic observation of the evolutions in order to improve the public decision quality and to define the regulatory framework for private decision-makers' activities. The international dimension of nanotechnologies and the changes that result from the convergence of nano-scale technologies with high transformational capacity, require a strengthened international dialogue that explains all the aspects of the international nanotechnology governance, included the responsibilities of every stakeholder. The recently created OECD Working Group on nanotechnology aims to contribute to the definition of the relevant indicators in order to improve the public decisions quality. The Working Group has been organized in various dynamics that will be presented. The first results are expected for the end of 2008, with an important working program for the period 2009-2010. These OECD dynamics that complete the work carried out in the framework of the OECD Chemistry Committee are only one aspect of the international responsible dialogue on nanotechnology. The impact and the efficiency of this dialogue are conditioned by its really inclusive nature in a highly competitive world. In this respect, the coordination of the nanotechnology policy among the different specialized institutions of UNO could be a short term perspective and it will therefore follow a dialogue that started in May 2008 on the consequences of the nanotechnology development for the Southern countries. Since 2004, the international influence of the process called Alexandria on the international responsible dialogue in the field of nanosciences and nanotechnologies, supported by the European Union, has also played a particularly useful role that needs to be reinforced. 16 Nanotechnology and manufactured nanomaterials - ongoing and planned work in the UK Jane Stratford, Defra, UK The UK Government’s vision for nanotechnologies is “for the UK to derive maximum economic, environmental and societal benefit from the development and commercialisation of nanotechnologies, and to be in the forefront of international activities to ensure there is appropriate control of potential risks to health, safety and the environment”. Nanotechnology was first identified as an area of great potential but where concerns are likely to be raised about the risks of the technology in 2003. The then Minister for Science and Innovation asked the Royal Society and the Royal Academy of Engineering to conduct an independent study. Their report ‘Nanoscience and nanotechnologies: opportunities and uncertainties’ was published in July 2004. It made a series of recommendations for Government on improving evidence for possible health, safety and environmental impacts; regulatory issues; social and ethical issues; and stakeholder and public dialogue. The Government’s response set out an ambitious agenda to address nanotechnologies and is subject to independent review after 2 years and 5 years. Nanotechnologies cuts across a range of Ministerial responsibilities. The UK Government has therefore established governance arrangements to drive the agenda forward: Ministerial Group on Nanotechnologies: Established in November 2008 to provide high level overview of Government activities. It includes Ministers responsible for science and innovation, environment, worker health and safety and public health; Nanotechnologies Issues Dialogue Group : Co-ordinates Government activities across Departments, Regulatory Agencies and Research funders; Nanotechnologies Research Co-ordination Group: Co-ordinates publicly funded research into the potential risks presented by the products and applications of nanotechnologies; Nanotechnologies Stakeholder Forum: informs policy on control of potential risks and maximising benefit; allows an exchange of information; represents the views of all stakeholder communities with an interest, and improves the accessibility of debate and discussion to the public. From the outset the Government has wanted to understand and address public aspirations and concerns for nanotechnologies we have therefore funded in-depth discussions between members of the public, scientists and others. All leads to increased transparency in policy development for nanotechnology. 17 NanoSafety in Thailand1 V 0.4 1 July 2008 Dr Lerson Tanasugarn, Chulalongkorn University, Thailand Thailand is a Southeast Asian Kingdom that has evolved from a strictly agricultural economy to follow the dream of becoming a newly-industrialized country. In the age of nanotechnology, both the academic and industrial sectors are quickly investing resources into development and production of various nanotechnology-based products including nanocomposite food packages, nanosensors, water-repellent fabric coating made of nanoparticles, nanoclay membranes for water treatment, and curcuminoid nanoliposomes (whitening) face creams, nanoalumina-doped ceramics-based artificial gemstones, nanochitosan-based slow-release drug vehicles, nanoparticle Organic Light Emitting Diodes (OLEDs), and nanodye-sensitized solar cells, etc. Although safety issues of nanotechnology and nanotechnology-based products have only recently been discussed in limited circles, the country has a well-established framework for hazardous material management that includes environmental hazards, health hazards, and workplace hazards. Governmental Offices and Bureaus responsible for dealing with these hazards are affiliated with several Ministries and have formed networks for expediting their responses. With regard to nano-hazards, The Thai National Nanotechnology Center (NANOTEC) is the policy focal point and an active implementer. It has already sponsored a Phase I NanoSafety and NanoEthics study that was conducted by Chulalongkorn University. The study identified the issues, the global players, and the present and future policy options that the country should consider. Currently NANOTEC is sponsoring Phase II of the NanoSafety and NanoEthics study, where critical reviews of related prior scientific studies are conducted in order to form a solid basis for subsequent NanoSafety and NanoEthics Guidelines. Meanwhile, NANOTEC has set its strategic goals for nanosafety research, including measurements of nanomaterials, risk exposure measurements, toxicity determination, screening test developments, risk assessments, and model validation. Thailand has thus set its course to become both an informed consumer and a nanomaterial producer with social responsibility that is compatible with global standards. Towards this end, the country needs strong international linkages for best-practice information, research collaboration, as well as standard and guideline development. 1. Country Background Thailand is a country in Southeast Asia with an area of approximately 514,000 sq km (about the size of France) and a population of approximately 63 million at the end of 2007. The country is the world’s No. 1 exporter of rice. Other major exports include textile and footwear, fishery products, rubber, jewelry, automobiles, computer and electrical appliances. The 2006 estimated nominal per capita GDP of Thailand is USD3,136 (or USD 9,200 Purchasing Power Parity). Although Thailand is considered by many to have graduated from a developing country into a Newly Industrialized Country (NIC) status, there are still large gaps in the distribution of income, the development of indigenous technological capabilities, and the level of research and development, especially in the private sector. 18 Status of nanotechnology in Nigeria: Prospects, Options and Challenges Prof. Olusegun O. Adewoye, NASENI, Abuja, Nigeria. This paper presents the positive efforts made by the Federal Government of Nigeria on the present status of Nigerian Nanotechnogy Initiative (NNI). Through the National Agency for Science and Engineering Infrastructure, the coordinator of this initiative; meetings and workshops have been organised where viable nanotechnology options for Nigeria as well as the needed research and development infrastructures relevant to each option were established. Efforts made by NASENI to increase the visibility of the NNI within the government circle and amongst the scientists and engineers within Nigeria and in the diaspora will be highlighted. Policy and scientific challenges facing the NNI will be discussed. Finally, recommendations for rapid take-off of this initiative will be made. 19 History and current status of Nanotechnology in Russia Contribution to global dialog on EHS issues Marine Melkonyan, A.V. Shubnikov Institute of Crystallography of RAS, Moscow, Russia Nanosciences and Nanotechnologies (N&N) in modern Russia have a long history of the governmental support. In 2007 a national initiative on the development of nanoindustry in Russia has been announced. The strategic goal of this initiative is to create the nanoindustrial sector, which would be able to compete with those of economically developed countries on the internal and international markets of nanoproducts. The following programmes are the main tools of the governmental support of N&N (http://www.spbcas.ru/nanobio/Nanobio08/Abstracts_all.pdf): - - Federal Targeted Programme “Research & Development in priority fields of Russia’s S&T Complex 2007-2012”, “Industry of Nanosystems and Materials” sub-programme Federal Target Programme “Development of the Infrastructure of Nanoindustry in the Russian Federation for 2008-2010”; Federal Space Program of Russia for 2006-2015; Federal State Program for Development of Defense-Industrial Complex of the Russian Federation for 2006-2010; Specialized Programmes of the Russian Academy of Sciences; Programme of the Russian Academy of Medical Sciences “Nanotechnologies and Nanomaterials in Medicine” for 2008-2015. Some years ago the evaluation of Nanotechnology risks for the environment and human health was not a priority in Russia. The first event in Russia, devoted to the risks and benefits of N&N in the frame of XII National Conference on Crystal Growth in Moscow (October 2006), demonstrated that Russian scientific community has recognized the importance of studies of Nanotechnology potential impacts on human health and environment. In Russia there is not currently research Programme underway to address human health and/or environmental safety aspects of Nanomaterials. But a number of R&T projects on impacts of nanomaterials are funded by Russian Foundation for Basic Research; by Federal Agency for Science and Innovation. Studies of physico-chemical properties of nanomaterials (in particular, nanoparticles) have been carried out within Russian Academy of Sciences (RAS). Some researchers are including toxicological, ecotoxicological and metrological aspects on Nanotechnology in their research, but there is no official network for these areas. A number of Russian organizations are the partners of the international projects on analysis of toxicity of nanomaterials, funded by ISTC (http://search.istc.ru/index.jsp?v=7).The special session “The international dialog on Nanotechnology risk assessment and management: opportunities for Russia” was held in the frame of the Second International Conference on Nanobiotechnologies” in SaintPetersburg (June 16-18, 2008, http://www.spbcas.ru/nanobio). This event was highlighted that there is the need and opportunity for Russia to join the international forum on the possible societal, health and environmental impacts of Nanotechnology. Some recommendations have been developed how to establish the national network for the area of Nanotechnology risk assessment; how to promote joining of Russia to the bodies responsible for international cooperation on environmental, health and safety impacts of Nanotechnology. 20 Current Status and Perspectives of the Nanotoxicity Research in Korea Kyung-Hee Choi, Ministry of Environment, Republic of Korea The Korean government well recognized the importance of potential risks of nanomaterials, and is conducting several projects on human health and environmental safety of nanomaterials. Ministry of Environment (MOE) has organized ‘inter-ministerial policy consultation body’ for proper management of nanomaterials/nanotechnology among relevant ministries. MOE started projects on human health and environmental safety of nanomaterials. The ultimate goal of this research is to support the establishment of infrastructure necessary to minimize potential risks derived from the manufacture, distribution and disposal of nanomaterials and nanomaterials-containing products. The research project includes: 1) identification of environmental release of manufactured nanomaterials; 2) characterization of physico/chemical properties of nanomaterials; 3) development of monitoring methods of nanomaterials in air and water; 4) (eco) toxicological assessment of nanomaterials by systematic molecular biology; 5) environmental exposure and fate of nanomaterials including LCA, and 6) preparation of test guideline for the risk management of nanomaterials. The project is designed that results would be used for the supportive data to international cooperation activities of OECD WPMN. The Ministry of Education, Science and Technology (MEST) has performed a research project named ‘environmental implications assessment of nanomaterials’. The outputs of the project include: 1) the characteristics of nanomaterials; 2) the domestic and overseas trends in industrial, social, pharmaceutical, human, and environmental effects on nanomaterials; 3) need for research on human health and environmental safety, and 4) a proposal for a new institute to address negative effects of nanomaterials. Korea Food & Drug Administration (KFDA) is conducting a series of research projects on the toxicity of nanomaterials from 2007 to 2015 aiming for the development of a toxicological assessment system of nanomaterials and establishment of the related guidelines for the area such as food, drug, medical product, and cosmetics. As a Korean representative for ISO, Korean Agency for Technology and Standards (KATS) has conducted works related to ISO/ TC 229. KATS submitted two standard proposals to ISO/TC 229. In the presentation, recent progresses of the nanosafety projects undergoing in Korea will be introduced. 21 The small and the risk - A view from the re/insurance industry Dr. Thomas K. Epprecht Swiss Reinsurance Company, Zurich, Switzerland Nanotechnology has become a major engine for economic growth. As an enabling technology it encompasses many disciplines and industries. The challenge is to master an increasing variety of nano-enabled products, and to identify potentially harmful properties that are currently neither well analysed, described or understood, nor regulated or differentiated from other, safe properties. Swiss Re promotes the development of tailored risk management principles and supports regulatory efforts to prevent unknown exposure and ensure a balanced public dialogue on possible risks. Because progress is gathering pace, currently covered nanotechnology risks affect an ever wider variety of insurance policies and reinsurance treaties, and influence return on assets. As the leading reinsurance risk carrier, Swiss Re strives to be at the forefront of efforts to identify and understand the insurability challenges posed by nanotechnology and other emerging risks. At the same time, industry, risk research and regulators have stepped up their efforts to obtain a clearer picture about undesirable side-effects of nanomaterials and measures to govern risks appropriately. Insurance is a vital element in safeguarding economy and society over the long-term against the financial consequences of adverse events, and to enable them at large to take the risks that allow them to move forward. Swiss Re therefore believes that all parties with an interest or stake in safe nanoproducts must intensify dialogue and collaboration, to develop risk governance rules and adapt institutional and regulatory gaps where necessary. Find more about Swiss Re’s perspective in: http://www.swissre.com/pws/about%20us/knowledge_expertise/top%20topics/nanotech nology/nanotechnology.html 22 Role of National Nanotechnology Center (NANOTEC) and the Code of Conduct for Responsible Nanotechnology in Thailand Dr. Noppawan Tanpipat National Nanotechnology Center (NANOTEC) THAILAND The potential and rapid growth of nanotechnology may far outpace the new information and knowledge gained on its associated safety and health risks. As one preventive measure, timely targeted on Health, Safety and Environment (HSE)-research for nanomaterials is needed in defining risks and providing guidance for safe handling of nanomaterials. A concerted effort is needed by industry, academia, government and NGO to identify and address the existing knowledge gaps in a transparent and credible process that coincides with such development of this new technology. The National Nanotechnology Center (NANOTEC) will play an active role in this course of action through the conduct of scientific research in nanomaterials safety with regards to health in addition to policy and strategies to protect the researchers and workers alike. NANOTEC, however, is not a regulatory agency but a national research center and a granting agency, it therefore relies heavily on efforts made by others in achieving the ultimate outcomes for the workplace safety and preventive measures for health. With serge in public needs for awareness in nano-safety, NANOTEC strategically put together a development plan that includes a roadmap for risk assessment in the potential nanoscience and nanotechnology (N&N) applications for the advancement of occupational safety and health in the workplace. The complementary NANOTEC nanosafety research findings and the existing guidance are utilized in establishing a protocol for safety conduct coordination in N&N research across the Center. In addition, it is intended to be employed as a monitoring tool for emerging research development in response to new challenges in N&N. Meanwhile, the strategic plan will have a cohesive, multidimensional, and timely nanomaterials research agenda that will properly address the information and knowledge gaps concerning possible exposures of nanomaterials, health risks from such exposure, whilst also development of control and prevention measures to protecting Thai citizens from potential harms related to nanotechnology. 23 Nanotechnology in a Developing Country – Applications and Challenges Babajide I. Alo, University of Lagos, Nigeria Developing countries and countries in transition are making some halting progress in adopting and mainstreaming nanotechnology options in the respective national development agenda. However, as commodity production and workable low-tech alternatives remain the backbone of most developing nations, this paper will provide a short review of the current dilemma in balancing the opportunities, social utility, risks associated with and the potential profound effects of adoption of nanotechnology in a limited developing economy. The paper contends that global policy responses for nanotechnology need to promote responsible actions regarding this innovative enabling technology, including increased awareness and full dialogue, justification of relevance and import to developing economies, together with the possible challenges including socioeconomic and ecological issues surrounding new technologies that could have an impact on the world’s poorest and most vulnerable. 24