By Dr. Christoph Meili, CEO, The Innovation Society, St.Gallen, Switzerland

Nanotechnology (NT) is a rapidly growing field with an increasing significance for science, business and society. The Swiss Federal Government has published a Nanotechnology Action Plan[1] on synthetic (manufactured) nanomaterials in April 2008. The Action Plan analyses the situation and suggests a package of measures in four different areas: 1. Research activities; 2. Communication and public dialogue; 3 Risk assessment and regulation and 4. Efficient use of resources.

The Swiss Action Plan analyses the current situation and suggests measures
Switzerland has always been a forward-minded country with a strong scientific and business community interested and working in the field of NT. On the other hand the Swiss regulatory bodies have also been analysing the potential risks and the regulatory frameworks. In the light of the current lack of HSE risk data on synthetic nanoparticles[2], it became clear that a stable and predictable regulatory framework and several accompanying measures are necessary to guarantee the sustainable and successful development of NT. In this context the Swiss Federal Office for Public Health (FOPH) and the Swiss Federal Office for the Environment (FOEN) in cooperation with other organizations published an Action Plan in spring 2008. The objectives of the Action plan are:

• creating a framework with conditions for a responsible handling of synthetic nanoparticles
• creating scientific and methodological instruments to recognise and prevent possible harmful effects of synthetic nanomaterials on health and the environment
• promoting a public dialogue about the promises and risks of nanotechnology
• supporting the use of existing instruments to enhance the development and market launch of sustainable nanotechnology applications.

The Action Plan suggests a package of measures in the areas of communication and public dialogue, nanospecific research, risk assessment and regulation and resource efficiency and sustainability.

Communication and public dialogue
Communication with the public and an open dialogue with stakeholders are key factors for the success and acceptance of a new technology. The public is asking for balanced, comprehensible and unbiased information. On the other hand there must be a broad involvement of all stakeholders in the public field. Most importantly, in order to support an independent opinion and decision making process in the civil society, communication has to include both opportunities and risks. The Action Plan therefore suggests the following measures :

• providing information for stakeholders on easily accessible platforms
• promoting public dialogue by supporting dialogue platforms and initiatives
• supporting activities of technology assessment (studies, publifocus groups, etc.).

Effects on humans and the environment and health protection at the workplace
As mentioned above the database about potential adverse effects of synthetic nanomaterials on human health and the environment is still weak. There are many open questions regarding possible negative effects of synthetic nanomaterials on health and the environment, on identifying the sources of pollution, and on possible safety risks. Current recommendations in the field of occupational safety are almost exclusively based on analogies to particles in the micrometer range. As long as there are no findings proving a substance’s hazards, the existing and effective protection strategies for substances of unknown hazard potential should be applied and the exposure at the workplace should be kept at a minimum level. As far as the standardisation and the measurement of synthetic nanomaterials are concerned, there has to be a joint effort on an international level where Swiss stakeholders have to participate and provide useful input. The Action Plan therefore suggests two different packages of measures:

• an increased support for independent risk research in nanotechnology
• participation of Swiss representatives in international commissions on standardisation and measurement (ISO, OECD)

In November 2007 the Swiss Federal Government launched a national research initiative (NFP) on opportunities and risks of nanotechnology and granted 12 Mio CHF.

Risk assessment and regulation
In Switzerland – as in all other european countries – there are no nanospecific laws in force. Synthetic nanomaterials are regulated as conventional (=bulk) chemicals. Swiss regulations have therefore several statutory instruments to deal with nanomaterials:

1. approval and notification procedures: Are usually coupled with an obligation to perform toxicity tests (depending on the substance).
2. self-supervision: The manufacturer has to assess product safety independently and has to inform the customers.
3. prohibitions or limitations on use: Based on the results of risk assessments, threshold values and emission limits.

Due to the still missing database on potential risks the precautionary principle has to be applied. Facing the complex and heterogeneous nature of synthetic nanomaterials and their applications, a transparent risk assessment based on simple criteria is necessary. On the other hand, voluntary measures have to be stimulated in order to promote the self-reliance of the industry. Therefore the following measures are suggested in the first phase:

• development of a risk-framework for products and applications with specific nanomaterials
• support self-supervision and measures of occupational health protection
• promote voluntary measures by the industry (e.g. Codes of Conduct[3], CENARIOS[4]) in the manufacture, marketing and use of products containing nanomaterials
• disclosure of safety information and data to the processing industry
• informing consumers about products containing synthetic nanomaterials
  regulations for the disposal of products containing nanomaterials.

In the second phase (medium and long-term) it will be examined whether statutory measures, which go beyond today`s regulation, are necessary.

Resource efficiency and sustainable use of NT
Due to their revolutionary properties, many nanotechnologies are regarded as being suitable of contributing to the development of greener and more sustainable products and processes by promoting resource efficiency and energy savings. The cooperation between scientific organisations, public funding agencies and the industry will therefore be promoted and supported.

Conclusion
Nanotechnology offers many promising scientific and economic opportunities for Switzerland. Considering the fact that there are many unknowns concerning the potential risks of synthetic nanomaterials for human health and the environment, clear guidelines and transparent strategic governance are necessary. The Swiss Federal Offices for the Environment and Public Health in cooperation with other stakeholders have developed an Action Plan in order to proactively address critical issues and to suggest specific measures in several fields to provide good conditions for a sustainable and successful use and development of nanotechnology. The Action Plan has been planned and realized in cooperation and negotiation with all relevant stakeholders since 2006. Therefore the suggested measures are all consensus based and the outcome of a joint effort of all involved stakeholders. The commitment of all relevant stakeholders to the Action Plan is the key element, because this will guarantee the efficient and pragmatic realization of the suggested measures.

DR. CHRISTOPH MEILI is CEO of the Innovation Society, St.Gallen and senior lecturer at the University of St.Gallen. The Innovation Society is an international consulting and research firm. The company provides risk-management services, business information services, and communication services. The company has advised the Swiss Federal Offices in elaborating and implementing the Swiss Action Plan for Nanotechnology. [email protected]

References
1. The Action Plan can be downloaded here.
2. Meili, C, Widmer, M. Husmann, F. et al (2007). Synthetische Nanomaterialien, Risikobeurteilung und Risikomanagment: Grundlagenbericht zum Aktionsplan. (Umwelt-Wissen No. 0721, Federal Office of Public Health and Federal Office fort he Environment, Bern. 284 p. The English summary of the report is available here.
3. There are already several Code of Conducts (CoC) published for nanotechnology (BASF, EU). In April 2008 the Swiss Retailer`s Association (IG-DHS) and the Innovation Society (St.Gallen) published the first “Code of Conduct” for nano consumer products.
4. CENARIOS (Certifiable nanospecific risk management and monitoring System) is the first certifiable safety system which was developed by TÜV SÜD Industry Service Ltd (Munich) and Innovation Society in 2007 and is already in use.