IFCS/FSC/WG Nano/ 04 rev 4
DRAFT Version 4
6 February 2008
Nanotechnology and manufactured Nanomaterials:
Opportunities and Challenges
IFCS Forum VI
Thought Starter[1]
Objective of the plenary session:The objective is to exchange information in order to help raise the awareness of participants to the potential new opportunities, the new challenges and the new risks posed by nanotechnology.
The meeting will provide a forum to share information on known and emerging issues, on the work of the OECD, ISO and UNESCO 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 pollution prevention, and to discuss how to achieve an equitable distribution of benefits and risks and role of responsible stewardship in addressing nanotechnology.
Table of Contents:
1 Background 3
2 Ethical considerations 4
3 Social utility of nanotechnology 4
4 The state of the knowledge about the risks of nanomaterials 5
5 Communication and public dialogue 5
6 Activities of International Organisations 6
7 Activities of non-governmental organizations 7
8 National activities, interests and priorities on nanotechnology and manufactured nanomaterials 8
Belarus 8
China 9
European Commission 9
Germany 14
Korea 15
Nigeria 16
Slovenia 16
Switzerland 17
Thailand 18
United Kingdom 19
9 Annex 20
9.1 Definitions and types of manufactured nanomaterials 20
9.2 Health risks 21
9.3 Occupational health 22
9.4 Environmental risks 23
9.5 Ethical issues 24
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IFCS/FSC/WG Nano/ 04 rev 4
DRAFT Version 4
6 February 2008
1 Background
Nanotechnology is an enabling technology that is expected to result in major changes across many industry sectors and to contribute to novel materials, devices and products. Depending on the area of application there are different timelines for the beginning of industrial prototyping and nanotechnology commercialization. First generation products are already on the market such as paints, coatings and cosmetics. More products such as pharmaceuticals, diagnostics and applications in energy storage and production are in development. Many studies have tried to estimate the prospect of the nanotechnology market with different data. In general the areas of nanoelectronics (semiconductors, ultra capacitors, nanostorage and nanosensors) are estimated to be around 450 billion $ for 2015, and the areas of nanomaterials (particles, coatings and structures) are estimated to account for 450 billion $ in 2010[2]. Further generations of nano-enabled products based on active nanoscale structures and nanosystems will be developed in the future. Such developments will address innovations looking into processes of technical modernization and changes in the interface between humans and machines/products. Presently discussion on opportunities and challenges of nanotechnology and manufactured nanomaterials focuses on 1st generation nanoproducts. It is incumbent on governments to develop a regulatory framework which enables the responsible introduction of manufactured nanomaterials through the scientific assessment and appropriate management of the potential risks. The thought starter gives an overview of the topics relevant for this discussion. The scope does not include the area of medical diagnostics and treatment as this is being addressed in other fora.
Nanotechnologies and manufactured nanomaterials, as with any new technology, may bring many advances to society and benefits for the environment, but also pose new challenges in health, environment safety and possible impacts on society. Because of the very broad range of potential applications using nanotechnology and the wide variety of characteristics displayed by manufactured nanomaterials, detailed discussion of both benefits and of heath and environmental risks should take place at the level of individual nanotechnology applications.
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 policy issues. These can include health, safety, moral, ethical, societal, legal and social utility concerns. In view of the predicted great impact of nanotechnologies on the global economy, research and society, and of the expected wide-spread use of nanomaterials, any possible risks should be studied by comprehensive, proactive risk estimation and assessment.
The nanotechnology agenda item at IFCS Forum VI is to provide an overview of current work and debates on nanotechnology and inform stakeholders of where these discussions are occurring.
2 Ethical considerations
Only a few ethical committees have explored the ethical challenges posed by this technology. As the Royal Society acknowledged, “These questions are not unique to nanotechnologies but past experience with other technologies demonstrates that they will need to be addressed”[3]. A number of prestigious reports (e.g. UK Royal Society) and coalitions (labour, environmental, and civil society groups) have advocated for the precautionary approach to apply to development and commercialization of manufactured nanomaterials. The precautionary principle is often discussed in ethical committees. Other issues also identified as priorities for discussion include: agreement on socially acceptable or unacceptable risks, the social and global distribution of benefits and risks, ownership/patent issues, health and safety risks to workers and the public, regulatory oversight, and moratorium on technological applications. These, as well as whether and to what degree a precautionary approach should be adopted, are often discussed in ethical committees (see Annex 8.5).
3 Social utility of nanotechnology
The way in which we use available natural resources has effects on our health and the environment and is to a large part heavily influenced by cultural aspects and personal choices. Natural resources are an important factor in the economy and an important element of our welfare. Technological innovations, including those resulting from nanosciences and nanotechnologies, can play a key role in the more efficient use of our resources.
Before the development or use of any application from nanotechnologies, the question of social utility should be asked. To answer that question the potential contribution of specific applications from nanotechnologies to solve a specific socially relevant problem such as climate change, water shortages and starvation should be known. Health and environmental risks and possible side effects on society and economy should be taken into account as well as existing alternative solutions. The result of such an evaluation will always be a local decision (country, region).
For the majority of developing countries, commodity production is the backbone of the economy[4]. Historically, advances in science and technology have also had profound impacts on commodity production and trade. There are concerns that nanotechnology will change the commodity markets, disrupt trade and eliminate jobs. Worker-displacement brought on by commodity obsolescence will hurt the poorest and most vulnerable, particularly those workers in the developing world who don’t have the economic flexibility to respond to sudden demands for new skills or different raw materials. Currently, nanotech innovations and intellectual property are being driven mainly from developed countries. The world’s largest transnational companies, leading academic laboratories nanotech start-ups are seeking intellectual property on novel materials, devices and manufacturing processes. Commodity dependent developing countries must gain a fuller understanding of the direction and impacts of nanotechnology-induced technological transformations, and participate in determining how emerging technologies could affect their futures.
There are concerns as well that developed countries will benefit more from nanotechnology and that developing countries will suffer more from potential risks (e.g occupational health and safety standards may be lower, waste management and waste disposal infrastructure may not be adequate for nanomaterials and nano-enabeled products).
4 The state of the knowledge about the risks of nanomaterials
Materials are used at nanometric scale for their new properties. One can expect effects of the same level on health and environment.
Various studies have shown that, because of their small size, unbound nanoparticles can be inhaled and enter the bloodstream via the lungs, disperse throughout the body and penetrate other organs, however it should be noted that many of these studies use instillation rather than inhalation as a way to administer nanoparticles, and generally in a greater quantity dose than reflects actual practical circumstances. It has also been shown that, depending on their properties, some manufactured nanoparticles can be damaging to cells. Little data is available on the toxicology, release, environmental behavior and safety of nanomaterials. Although a few studies have been carried out, not all of their results are meaningful, since many of these investigations were carried out using very high concentrations of particles, and with samples or reference materials that had not been accurately characterized (see Annex 8.2, 8.3, 8.4). Several countries have launched research programmes to reinforce independent risk research (see point 7). Greater coordination of these programs could facilitate more efficient use of time and resources.
In the literature it is often stressed that results for one nanoparticle cannot be generalised to other nanomaterials. This is mainly because the characteristics that influence toxicity have not yet been defined. Standardised test protocols and standardized reference compounds would enable comparisons to be made between the different materials and studies. International organizations such as OECD and ISO and national agencies have established programmes to fill this gap (see point 6).
Based on the scientific and methodological principles currently available, no conclusive requirements for the safety of manufactures nanomaterials can yet be formulated. Nevertheless, safety precautions must be taken based on a precautionary estimation of hazard and exposure risk, as with hazardous materials. As soon as the conditions for evidence-based risk assessments of manufactured nanomaterials are present, existing statutory frameworks need to be assessed, and, where necessary amended, to provide conditions for the safe handling of such materials and of nano-enabled products throughout their life cycle. As more knowledge becomes available, safe handling guidelines can be iteratively formulated and revised.
5 Communication and public dialogue
Broad information on opportunities and risks of nanotechnology and nanomaterials is important for public opinion making. Communication is a key prerequisite for the public engagement with new technologies. This opinion-forming process may leave its mark on the development of technologies and their application. Communication should therefore extend further than the field of manufactured nanomaterials to encompass all of nanotechnologies. It should reflect the current state of social, scientific and political knowledge and of public engagement. Account should be taken of both the promise of nanotechnologies and the public fear or rejection it may create.
The involvement of industry, authorities and the public in the debate on opportunities and risks must be an integral part of technological development. For an integrated approach, this debate should be as broad as possible and not restricted to individual levels or topics (e.g. scientific, psychological, sociological). A challenge is to communicate information on risks and benefits to enable a public dialogue and informed decisions; the challenge will be even more difficult in developing countries. Dissemination of awareness of possible risks of nanotechnology to the public of developed and developing countries should be coupled with positive aspects of nanotechnology, particularly in development of monitoring tools. It should be noted that nanoparticles are released in large quantities in industrial processes as unintended by-product of combustion, welding, explosions, etc., but their detection is currently very limited, mostly due to the lack of established detection mechanisms and because of lack of awareness of the need for monitoring. Many different ways of detection of nanoparticles of different kind can be foreseen.
6 Activities of International Organisations[5]
OECD has established under its Chemical Committee a Working Party on Manufactured Nanomaterials (WPMN). It aims to promote human health and environmental safety implications of manufactured nanomaterials in order to assist in their safe development (limited to mainly the industrial chemicals sector). The following eight projects are in the workplan of the WPMN:
· Development of an OECD Database on Human Health and Environmental Safety (EHS) Research
· EHS Research Strategies on Manufactured Nanomaterials (including Occupational Health and Safety)
· 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 Nano Toxicology
· Exposure Measurement and Exposure Mitigation
OECD’s Committee for Scientific and Technological Policyhas established a Working Party on Nanotechnology (WPN). Its aim is to look at the responsible development and use of nanotechnology and the potential benefits nanotechnology can bring to society, taking into account public perceptions related to advances in nanotechnology and its convergence with other technologies, without forgetting legal, social and ethical issues. The following projects are in the work plan of the WPN:
· Statistics and Measurement
· Impacts and Business Environment
· International Research Collaboration
· Outreach and Public Engagement
· Dialogue on Policy Strategies
· The Contribution of Nanotechnology to Global Challenges
ISO has established Technical Committee 229. Currently the following 3 working groups have been established: terminology and nomenclature; measurement and characterization; and, health, safety and environmental aspects of nanotechnology. 10 work items spread across these three work areas are currently under development.
UNESCO Ethics of Science and Technology Programme[6] was created in 1998 with the establishment of the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) to give an ethical reflection on science and technology and its applications.
This programme aims to promote consideration of science and technology in an ethical framework by initiating and supporting the process of democratic norm building. This approach is founded upon UNESCO's ideal of "true dialogue, based upon respect for commonly shared values and the dignity of each civilization and culture". Awareness raising, capacity building and standard-setting are therefore the key thrusts of UNESCO's strategy in this and all other areas.
UNESCO has invited well-known experts in nanotechnology to discuss the state of the art of nanotechnology, examine the controversy surrounding its definition and explore related ethical and political issues. A 2006 report “The Ethics and Politics of Nanotechnology”[7]; "outlines what the science of nanotechnology is, and presents some of the ethical, legal and political issues that face the international community in the near future." UNESCO has recently published a book on "Nanotechnologies, Ethics and Politics"[8]. The aim of the book is to inform the general public, the scientific community, special interest groups and policy-makers of the ethical issues that are salient in current thinking about nanotechnologies and to stimulate a fruitful interdisciplinary dialogue about nanoscale technologies among these stakeholders.