regards-citoyens

Executive Summary

Nanotechnologies are set to transform industrial society. Nanotechnologies allow for the manipulation of matter or creation of structures down to the molecular level (typically at a scale of approximately 100 nanometres or less, a nanometre being one- billionth of a metre). They promise benefits in a wide range of applications, from health care to food, cosmetics, chemicals, information technology and energy storage.

Nanomaterials are already being used in numerous consumer products, and more commercial applications can be expected in coming years. At the same time, a gap has emerged between the development of nanotechnologies and our understanding of how nanomaterials interact with the environment and the human body. Early results of research suggest that the safety of all nanomaterials cannot be taken for granted. The ongoing expansion of nanotechnologies may produce novel nanostructures that cause currently unknown forms of hazard. Developing nanomaterials governance that is both effective and proportional to potential risks is critical to the future success of existing and emerging nanotechnologies.

The European Union and the United States are worldwide leaders in the scientific and commercial development of nanotechnologies. Their regulatory responses to potential risks will send an important signal worldwide. In the past, they have cooperated in international efforts to harmonize their respective risk regulation, through the Organization for Economic Cooperation and Development (OECD) and the World Trade Organization (WTO).

Where successful, such efforts have promoted high levels of protection while enabling scientists and industries to operate freely in the transatlantic economic space.

In some cases, however, transatlantic coordination and cooperation have proved difficult. Differences in legislative frameworks, regulatory cultures and societal risk perceptions can contribute to a divergence of regulatory responses. This was the case, for example, with high-profile transatlantic disputes over hormone-treated beef and genetically modified food, which have had a negative impact on transatlantic relations and trade. These experiences have shown the importance of identifying technological risks and promoting international cooperation at an early stage in the policy process.

This report aims to contribute to the debate on how best to address the risks of emerging nanotechnologies and how to promote coordinated and convergent approaches in the EU and US. It presents the main findings of a project that was carried out by a consortium of research institutions from both sides of the Atlantic: the London School of Economics and Political Science (LSE) and Chatham House (the Royal Institute of International Affairs) in the UK, and the Environmental Law Institute (ELI) and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars in the United States.

The project was funded by a research grant from the European Commission, and is based on extensive consultation with experts and stakeholders in nanomaterials regulation on both sides of the Atlantic. It provides a detailed comparative analysis of EU and US regulatory frameworks in the key areas of chemicals, food and cosmetics, and identifies options and challenges for policy-makers and regulators in promoting greater transatlantic cooperation and convergence in nanomaterials regulation.

Regulatory challenges of nanomaterials

Governments in leading industrialized countries are currently relying on existing frameworks for environmental, health, and safety (EHS) regulation to deal with nanotechnology risks, making minor adjustments to specific regulations and their implementation in order to close any potential gaps or eliminate uncertainties. Regulators face a number of challenges in dealing with the potential risks of nanomaterials. These challenges are related to a series of uncertainties, with regard to the development and commercial application of nanomaterials, hazards and exposure pathways, the direction and speed of technological change, and the suitability and effectiveness of existing regulatory frameworks.

Rapid technological change. While the current regulatory focus is on passive nanomaterials, future developments will include active nanomaterials and are likely to converge with other technologies such as information, bio- and cognitive technologies. These future-generation nanomaterials will develop in ways that are difficult to foresee.

Regulators will need to constantly expand their knowledge base covering multiple areas of scientific and engineering inquiry and develop flexible responses to a constantly changing technological environment.

Uncertainty of commercialization paths. While the number of existing commercial products using nanomaterialskeeps growing, uncertainty exists regarding future commercialization paths. As the range of commercial applications expands, governments will have to address potential risks of nanomaterials in diverse regulatory contexts covering different industries and commercial applications, potentially adding to existing uncertainty about the regulatory coverage of nanomaterials risks.

Uncertainty regarding nanomaterials risks. A lack of data on hazards and exposure pathways of certain nanomaterials, combined with uncertainty about the applicability of some existing testing methods, are widely recognized impediments to the effective implementation of regulations. It is, therefore, too early to establish whether existing regulatory frameworks can and will be effective in the face of potential risks.

Uncertainty regarding the suitability of regulatory frameworks. Whether current laws provide adequate oversight for certain applications of nanotechnologies or whether new legislative instruments are needed depends very much on how existing statutes and regulations are implemented. Adequate guidance for implementation and the provision of the necessary resources for regulatory oversight thus become critical factors in developing effective regulatory responses.

Uncertainty regarding regulatory and scientific resources. The challenges that novel technologies such as nanotechnology present require significant investment in human resources. Statutes are a necessary but insufficient condition for success if the regulators lack enforcement capacity, scientific expertise and foresight. The public sector will increasingly have to compete with industry for talent in these emerging technology areas.

Towards regulatory effectiveness and convergence: policy recommendations

What should the EU and US do to promote more effective and convergent regulation of nanomaterials ? Below we present key policy-relevant findings of this project, based on our own research and consultations with relevant experts and stakeholders. We focus on three clusters of issues that we identified as the most important areas : the creation of the scientific building blocks that are necessary for risk assessment; the closure of existing knowledge gaps with regard to the commercialization of nanomaterials and potential EHS risks; and questions of societal and ethical perspectives and how they are addressed in risk management. We conclude with an outlook on the global challenges of developing nanomaterials regulation in a world of internationally integrated markets and new nanotechnology producers in emerging economies.

Creation of scientific building blocks

Nearly all experts whom we consulted agreed on the need to establish a firm scientific basis for risk assessment.

Many of the scientific building blocks, with regard to definition and characterization of nanomaterials, metrology and testing methods, are as yet missing or have not been internationally standardized. Developing common practices in these areas is a critical step towards more effective regulation; they are key building blocks of risk assessment.

Regulators and experts in the US, Europe and elsewhere are currently seeking to fill existing gaps by working together in various international forums. Our research suggests that ongoing work on creating scientific building blocks for risk assessment needs to be stepped up and expanded if it is to produce results in a timely fashion. The rapid pace of commercialization of nanomaterials demands a greater sense of urgency in this area.

The OECD enjoys broad legitimacy in promoting coordination on the building blocks for risk assessment, and is a central institution in the context of transatlantic regulatory convergence. At the same time, more political energy and resources need to be invested in the OECD process and greater transparency and inclusiveness should be achieved in its work.

Closing knowledge gaps

Furthermore, regulators face two important knowledge gaps, with regard to the EHS risks associated with the production and use of nanomaterials, and the presence of nanomaterials in commercial products. These two dimensions of uncertainty are closely linked and complicate the search for effective regulatory answers. Knowing as soon as possible what types of nanoscale products are on the market, what types of nanomaterials are used and how they move through possible product life-cycles provides some grounding for establishing research needs in the field of EHS risks. Uncertainty in both these areas afflicts US and EU regulatory systems in equal measure. Transatlantic cooperation on reducing uncertainty with respect to the commercial use of nanomaterials and on EHS risks would help both sides in addressing certain regulatory challenges.

Accordingly, as a matter of priority, governments on both sides of the Atlantic need significantly to increase funding for research into EHS risks of nanomaterials. International research coordination has its limits and can be difficult to achieve, but the benefits of improved transatlantic coordination of EHS research outweigh the costs.

Against the background of strained public finances and urgent research needs, enhanced transatlantic cooperation would give a greater sense of strategic direction to existing research efforts and strengthen the basis for sustained research funding streams into the future.

Furthermore, we encourage regulators and policy-makers to explore all options available to them, whether through domestic reform or international agreement, for promoting better information-sharing of EHS risk-related data on nanomaterials that ensures commercially sensitive data remain protected.

A second knowledge gap concerns the state of the commercialization of nanomaterials. Many companies themselves are uncertain about the use of such materials within their own industry, and regulators on both sides of the Atlantic have acknowledged that they currently do not have comprehensive knowledge about their presence in commercially traded goods. Recently introduced voluntary substances reporting programmes are unlikely to close such knowledge gaps.

Given the persistence of these knowledge gaps, governments on both sides of the Atlantic should strengthen existing mandatory reporting requirements and, where necessary, create new ones, with a view to gaining a comprehensive overview of the commercial use of nanomaterials. Given the high degree of economic interdependence between the US and EU, any effort to enhance market transparency through improved reporting schemes would benefit from a coordinated effort by both sides.

Risk management and consumer labelling

Efforts to promote international coordination and cooperation are currently focused on establishing the scientific building blocks needed for risk assessment. In comparison, transatlantic coordination efforts on risk management are likely to be less productive, may be premature, and would face greater obstacles. At the same time, the internationalization of the nanosciences and nanotechnologies will inevitably bring any differences in risk management approaches into sharper focus in transatlantic relations. As more and more nanomaterials are adopted commercially and enter global supply chains, differences in national or regional risk management approaches may end up complicating the free flow of goods across national boundaries. For this reason, coordination in the area of risk management will need to be given greater prominence on the international agenda in the coming years.

One important but controversial element of risk management is consumer labelling. So far, neither the US nor the EU has introduced legally binding consumer labelling requirements that specifically target nanomaterials, but moves are under way, particularly in the EU, to introduce such technology-specific labelling systems and some limited labelling requirements already exist, e.g. in food regulation. Our interviewees expressed strongly divergent views on the need to go beyond this state of affairs by creating more comprehensive labelling requirements, and on whether more convergent approaches could and should be developed in this area.

In the light of the contentious nature of labelling, in terms of its general necessity and specific form of implementation, we conclude there is no overwhelming case for arguing that the US and EU should prioritize international efforts to create new, mandatory, labelling requirements or harmonize existing ones at this time. But US and EU authorities should explore the implications of potentially diverging consumer labelling requirements for nanomaterials, particularly in the context of international trade obligations.

Furthermore, if the US and EU were to explore the possibility of developing common approaches or standards for nanomaterials labelling, such an undertaking should involve a multi-stakeholder forum to engage relevant groups from industry and civil society in order to give full weight to the different commercial and ethical concerns. Such an effort would be less urgent than the creation of common building blocks for risk assessment, but is nevertheless important in its own right.

Addressing global dimensions

No efforts have been undertaken as yet to create a formal, treaty-based, international framework for nanomaterials regulation. Our research suggests little if any interest in pursuing the more ambitious objective of creating an international treaty on nanomaterials regulation. The political energies that would need to be invested in such a project are better spent on strengthening existing forums for international coordination and adjusting domestic regulatory frameworks where needed. Given the globalized nature of nanotechnological developments and commercialization, however, one cannot rule out the possibility that such a need for an international framework treaty might arise in the future, particularly as new players from the developing world are emerging in the global nanotechnology business.

In view of the ongoing and accelerating globalization of nanotechnologies, the EU and the US should perceive the global governance challenges arising from nanomaterials in broader terms. The OECD serves an important function as a forum for coordination among leading industrialized countries, but its work should be complemented by the development of international governance capacity in other areas, and there should be greater inclusion of developing countries. Other international organizations, such as the United Nations Environment Programme (UNEP) and the World Health Organization (WHO), play important roles in their respective areas of global environmental protection and health promotion, but are only just beginning to identify the EHS risks of nanomaterials as emerging areas of concern. The current imbalance in the development of international governance capacity should thus be redressed, not least to ensure that developing countries are better represented in global regulatory cooperation.

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The complete report :  14692_r0909_nanotechnologies.pdf