Nanotechnology and ‘Coping rationally with risks’

The government paper entitled ‘Kabinetsvisie nanotechnologieën - van klein naar groots’ [The Dutch government’s vision on nanotechnologies - from small to great] (Netherlands’ government, 2006) sets out the course that the government wishes to take in the innovation and development of

nanotechnologies, as well as in relation to dealing with the risks of nanotechnologies. The government’s vision on the subject can be summarised as follows:

Nanotechnologies are new technologies on which a great deal of research is already being carried out worldwide and which are increasingly being applied. It is important that the Netherlands be a part of this and thus not only tries to keep up in terms of knowledge but is also among those at the vanguard. Furthermore we must bear in mind the potential risks attached to nanotechnologies. Only by carefully dealing with the risks can the Netherlands take full benefit from the opportunities (Netherlands’ government, 2006).

As this vision suggests, these opportunities lie in the area of promoting a good research climate, strengthening the ability of industry to compete, and for society in areas such as healthcare, safety (protection), and the environment. The aim of the government paper is to ‘indicate whether the frameworks which are necessary for responsible development are adequate, or whether they should be modified or updated’ (Netherlands’ government, 2006).

One of the main themes in the government paper is the topic of ‘coping with risks’. For which, among other things, the current legislation in force was considered. As the government sees it, the general principles of the current regulatory framework also apply to the risks of manufactured nanoparticles (see Annex 4). However, for the purposes of supervision and enforcement the knowledge gaps are still too great. As long as there are no suitable and manageable measuring methods in place, for example, supervision, compliance and enforcement remain difficult to implement. According to the government paper, both government and industry need to have more information available, a common framework of understanding needs to be developed, standardisation needs to take place and standard methods for measurement and risk evaluation need to be developed. For the purpose of developing and exchanging knowledge and expertise, an internationally coordinated research effort will be required.

For policy in the area of risk management the Ministry of Housing, Spatial Planning and the

Environment (VROM) policy document ‘Coping Rationally with Risks’ provides a starting point. This policy document deals with ‘risk governance’ in the context of the Netherlands. In Coping Rationally with Risks a number of problems are referred to concerning political decision-making about risks, including the assignment of responsibilities and the role of risk perception. In its efforts to manage the risks of nanotechnologies, the government will apply the principles in the VROM policy document (2004) (see also Chapter 1).

In addition, a number of international Codes of Conduct are being or have now been formulated for various target groups (EC, 2007; ICCA, 2007; Responsible Nano Code, 2008; VCI/BAUA, 2008). In Coping Rationally with Risks reference is made to the precautionary principle as set out in the Rio Declaration (Agenda 21):

The precautionary principle was incorporated in Principle 15 of the Rio Declaration: ‘In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent

environmental degradation’. The precautionary principle is also seen as ‘a strategy for risk management, if there are reasonable grounds for concern that potential hazards may affect the environment or human, animal and plant health, and when at the same time the available data preclude a detailed risk evaluation’ (VROM, 2004).

This policy document also makes reference to the principles formulated by the EU for the application of the precautionary principle:

‘The implementation of an approach based on the precautionary principle must be based on three specific principles:

• the application of the principle must be based on a scientific evaluation which is as complete as possible. This should, where possible, identify the degree of scientific uncertainty at each stage;

• every decision on whether or not to act on the basis of the precautionary principle must be preceded by an examination of the risk and the potential consequences of inaction;

• as soon as the results of the scientific evaluation and/or risk evaluation are available, all the interested parties should be involved in the study of the various options and the procedure should be as transparent as possible’ (VROM, 2004).

The government paper on nanotechnologies listed the following points for the ‘risk management agenda’:

1. Expanding knowledge on the applications and risks of nanoparticles (based on a common and international risk management process, together with industry and the scientific community); 2. The application of the precautionary principle with a sense of proportion. A moratorium on

nanotechnology and nanoscience would be undesirable from the point of view of proportion. For each application it must be determined whether extensive research is necessary prior to market introduction or whether other measures are necessary;

3. Metrology and standardisation. These are matters which are seen as essential by the government to be able to enforce legislation.

The theme of ‘coping with risks’ was further elaborated on in the letter which the Minister of Housing, Spatial Planning and the Environment, Mrs. Jacqueline Cramer, submitted to the Lower House of Netherlands’ Parliament in February 2008. The government’s aim, as set out in this letter, is ‘ultimately to reach a situation in which humans and the environment run little or no risk due to the use of

nanotechnology’. To achieve this, an approach will be adopted which was described as ‘nanoparticles will be treated with caution, care and common sense’ (Lower House of Netherlands’ Parliament, 2008). The letter referred, among other things, to the following activities which have been initiated in the Netherlands or to which the Netherlands is actively contributing:

• Drawing up a global knowledge agenda on assessment methods in the context of the OECD- WPMN. The international knowledge gaps are being identified by some eight working groups. The knowledge agenda will be published in September 2008. One of the topics which this will cover is regulation (both mandatory and voluntary) to obtain information on products;

• The compilation of the global knowledge agenda on standardisation will take place in the context of the ISO;

• In the EU context, efforts will be made to make the regulatory framework more enforceable and easier to implement. A national legislation survey will also be started to look at how substances and nanosubstances can be assessed and regulated;

• Investment in national surveys and research on the risks of nanotechnology;

• Publication of the Nanotechnology Action Plan (Lower House of Netherlands’ Parliament, 2008);

• Setting up a stakeholder consultative body:

o Consultation with trade and industry about the way in which the private sector meets its responsibilities in relation to the safety of processes and products, as well as to arrive at a joint approach to making the risks manageable;

o The government is counting on reaching agreement with the private sector about generating and sharing information and knowledge. The government also hopes to reach agreement with the private sector on openness, and expects that the private sector will commit to investing in risk research and risk communication with third parties;

o Consultation with civil organisations (which are currently often still in a start-up phase and are still defining their position and mission);

• The publication of the Coping with the Risks of Nanoparticles policy document in the second half of 2008.