The Language Game

Nanotechnology-related regulation cannot afford to be driven by rhetoric, or misled by obfuscation. Imagined futures and elusive definitions have been exploited by both proponents and opponents of greater regulation in the past, slipping ideologies in under the cover of uncertainty and confusion seen as having greater legitimacy than businesses regulating their own affairs behind closed doors. While harm to people and the environment has long been one of the important drivers of regulation, citizens have too often played a secondary role in the decision-making process. Over the past few decades, regulation of materials and products has typically been built on quantitative risk assessment – the purview of invisible experts – and quietly modulated by political and economic interests. The result has been a science-based regulatory approach that, while both professional and competent, nonetheless has tended to deal retrospectively with well- established risks. Increasingly though, citizens now expect to be able to challenge and influence regulatory decision-making which looks forward. Such citizen expectations produce new challenges in terms of transparency levels in public dialogue, but will need to be met if public trust of both governments and businesses is to be strengthened. Globally-organized consumers with considerable spending power and political influence have also begun to impact corporate and government policies, and to shape governance with their demands. This consumer power was perhaps most clearly seen in recent years with decisions on the use and labelling of genetically modified foods in Europe. But the trend towards organized citizens, whether as voters or as consumers, influencing risk-related policy is a general and growing one.

Moving past the ‘language game’ will be a tough challenge, as positions and perceptions often become entrenched in policy debates. There is a continuing temptation, as well, for nanotechnology to be used as a ‘lightning rod’ to open up all sorts of debates, ranging from policy shortfalls to global inequities. Yet it is also essential if progress is to be made. To help get out of the nano-rut, three steps will be important. First, the regulation conversation needs to be decoupled from the nanotechnology conversation. Although the two are closely related, the drivers, language and actions of oversight are not the same as those of the nanotechnology promotion. Second, the conversation needs to be grounded in evidence. We need to get back to basics and focus on sound science and work- able solutions. Third, a common language for addressing risks is needed that avoids confusion and enables dialogue. While this will overlap with the language of nanotechnology promotion, it should not be confused, driven or dominated by this language.

Filling the Science Gaps

Greater efforts are needed to develop and implement research strategies that identify and fill critical gaps in our knowledge base on nanotechnology-related risks and risk management. A number of knowledge gaps have been identified that require filling if existing regulations are to be better informed by evidence and new regimes developed. The barrier to progress here is not a lack of direction – it is relatively clear where we need to be – but a lack of a plan, priorities and resources to get there. Public and private, national and global efforts to fill these science gaps are growing, but still fall short of what is needed to underpin safe uses of nanotechnologies.

At the same time, further open-ended research is needed to help identify new science gaps. The challenges currently presented by simple nanotechnologies are reasonably clear; those that will be presented by later generation nanotechnologies are not. Only through strategically supporting and evaluating exploratory research will these new challenges become apparent.

Developing Appropriate Standards and Metrology

Progress towards addressing nanotechnology-related risks depends on being able to define the problem appropriately and having the tools to address it. Appropriate standards and metrology are essential on both counts. Both of these are closely related to the two preceding challenges. They form a basis for a common – and precise – language for addressing potential risks. And they enable the generation of valid – and validated – data that will underpin evidence-informed decisions. Yet there is a danger of developing standards and metrology that are not fit for purpose – especially if the driver is nanotechnologies promotion, rather than nanotechnologies regulation. As well, extensive efforts are underway internationally to develop and implement nanotechnology-related standards and guidelines. To be effective, these will need to share a common language and be supported by new research into identifying, assessing and managing potential nanotechnology-related risks. But they will also need to be assessed in terms of the added value they bring to policy and regulatory decision-making processes.

Identifying Regulatory Gaps

Regulatory bodies have their own inertia. Bureaucracy, resistance to change and a tendency to assume an unchanging world encourage the shoehorning of new challenges into old regulatory frameworks, rather than adapting regulations to emerging issues. This is not necessarily a bad trait – regulations that shift with every technological whim or as a knee-jerk reaction to some kind of real or perceived regulatory failure may be burdensome, built on shaky foundations and potentially counterproductive. Yet new challenges do arise – with increasing frequency as the rate of technology innovation accelerates – and regulatory frameworks need to be responsive to these new challenges. Responsive regulation cannot afford to be based on ill-defined imagined futures. Rather, it needs to be grounded in current realities and probable developments. Yet as increasingly novel materials, products and processes arise from technology innovation, foresight is needed to enable regulatory frameworks to adapt to emerging risks.

Current regulatory frameworks seem to be reasonably robust when it comes to first generation products of nanotechnologies, based largely on simple, passive materials. Admittedly there are clear weaknesses in existing regulations covering specific areas – but these are often weaknesses that exist for conventional products as much as emerging products and technologies. There is also considerable uncertainty over how existing frameworks apply to the products of nanotechnology, although here the challenge seems to lie predominantly with the interpretation and implementation rather than the regulations themselves.

Yet it is equally clear that nanotechnologies are beginning to stress regulatory frameworks and, as the technologies become increasingly sophisticated, these stresses may become significant and result in fractures. As nanotechnologies mature, products that cross multiple regulatory regimes are likely to lead to pressure coming to bear on the system. So-called ‘borderline products’, such as cosmetics that act as drugs, functional foods, and multifunctional drug/device combinations, will all challenge the applicability of existing frameworks. At a more basic level, nanotechnology-derived materials and products are already stressing regulations that are based on a chemistry worldview that is not overly responsive to the significance of form and functionality at the nanometre scale. Recognizing these stress points is a critical step to revealing weaknesses in existing regulatory frameworks and identifying triggers for change and adaptation.

Whether current and future regulatory gaps can be filled through evolutionary adaptation, or whether radical changes in the regulatory landscape are needed is still unclear. What is becoming increasingly clear, though, is that if our regulatory frameworks are to keep up with emerging technologies, they need to shed some of their inertia, and become increasingly responsive, adaptive and proactive – at the national as well as the international level.

Balancing Innovation and Safety

It is hard to imagine innovation leading to long-term sustainable progress without addressing the safety of the resulting products and processes at some point. At the same time, safety cannot be addressed effectively in the absence of products or processes arising from innovation. In other words, the two are inextricably intertwined. In the past, innovation has tended to precede discussions over safety by a considerable margin, leading to reac- tive oversight and regulation. In contrast, nanotechnology has provided a unique opportunity to integrate the safety dialogue into the development and innovation process at an early stage.

This early action raises the possibility of proactive oversight and the development of ‘responsible innovation’. Yet there are nonetheless concerns that the narrowly framed safety dialogue is merely an add-on to the innovation process, rather than integral to it.

In part, these concerns arise from the dual roles of promotion and oversight taken on by governments and industry. Governments have a strong interest in their considerable investments in nanotechnologies leading to economic stimulation and, while it can be argued that long-term gains depend on effective oversight and regulation, the short-term view is less clear. Likewise, industry has historically been reticent to unreservedly embrace safety measures that might potentially compromise productivity and profits. These perspectives do not necessarily do justice to progressive governments and industry taking a longer-term view on issues around the sustainability of technology innovation and its place in traditional industries. But there is also a question of accountability. Businesses are accountable to shareholders and other stakeholders. Government agencies are primarily accountable to their legislative objectives, missions and remits. Scientists are directly accountable to their funders and peers. As a result, the people likely to take the brunt of technology missteps are not necessarily those who the developers and implementers answer to directly. And as a consequence, the potential for conflicts of interest when addressing potential risks is far from trivial.

Re-balancing the innovation-regulation dialogue will depend on decoupling the risk conversation from the nanotechnology conversation, engaging stakeholders, and enabling citizens to play an active role in emerging technology policy. Given the complexity and diversity of nanotechnologies, it is essential that there is close two-way communication between developments in the science and technology, and identifying and acting quickly and appropriately on emerging risks. Yet the risk conversation cannot afford to be only driven by the developers and promoters of the technology, or unduly influenced by them. Likewise, addressing potential risks will depend on pulling in expertise from different stakeholders, and acknowledging that each group has a valid role to play in developing future policies and strategies. Similarly, citizens – people affected by policy decisions – have a critical role to play in contributing to these decisions. Ethically, it is questionable to deny citizens the opportunity to be a part of the process of technology innovation where it potentially impacts on their lives and livelihoods. Pragmatically, developments in global communication are enabling citizens around the world to organize and wield considerable influence – ignoring this emerging voice would be a serious mistake, as was demonstrated with the introduction of genetically modified foods in Europe. Engaging with citizens on science and technology faces many hurdles – few of which are ever overcome to everyone’s satisfaction. However, finding new ways of bringing citizens into the process of developing responsible technology innovation is essential to striking an effective balance between innovation and safety.

Moving Forward with Caution

The world today is a very different place from when many of the current regulatory frameworks covering materials and products were formulated. Indeed, one of the advantages of having conducted regulatory reviews for nanotechnologies has been the extent to which we now know more about the inadequacies of our current regulatory frameworks for existing materials and products. Advances in science and technology continue to challenge the robustness of these frameworks, and will continue to do so as technologies such as nanotechnologies and other emerging technologies like synthetic biology evolve and mature. At the same time social, political and technological changes are having their own impact on regulation. Social and economic globalization are challenging the relevance and utility of top-down, rigid and regionally constrained traditional regulation. Likewise, they are opening up new possibilities for developing alternate regulatory regimes and tools. The potential roles of insurance, intellectual property rights, voluntary programs and stake- holder partnerships in reducing risks are all becoming increasingly prominent in discussions, leading to a shift in emphasis from the traditional hierarchical systems of control to distributed regulatory frameworks which are more timely and responsive.

Yet evaluating what works in regulation is sensitive territory. There have, with any new technology, probably been periods of so-called under- and over-regulation. While regulatory evolution is essential, we would be remiss in throwing out the old and embracing the new, simply because it is there. Rather, the global community needs to proceed with caution in assessing where established regulatory regimes are stressed, and where alternate regimes can lead to more responsive – and more effective – regulation. This will require investment in multi-stakeholder initiatives at the national and international level that are tasked with evaluating regulatory barriers and options to emerging technologies – including nanotechnologies – and working with governments, industry and other stakeholders to implement viable solutions in priority areas. This will also require difficult assessments to be made by governments on the importance of nanotechnology regulation as against other regulatory priorities and on nano-risks as compared to other risks which exist more broadly. On this point, we might contrast the observation that there has to date been ‘no known cases of death that can be conclusively attributed to nanotechnologies or the use of manufactured nanomaterials’ against the reality of 34 017 road deaths which occurred in the US in 2008 or the 26 000 children under the age of five who die each day around the world, mostly from poverty-related and preventable illnesses.

Transparency and Trust

Two critical factors in today’s changing social and political landscape are the degree to which governments are increasingly applying regulation as a policy preference at the same time as individuals and citizen- communities are also seeking to increase their influence over regulatory decision-making. The continuing tensions between the European Parliament and the European Commission over future regulatory directions for nanotechnologies, for example, are indicative of both. They remind us that in western liberal democracies, citizen power, through their elected representatives, remains supreme. They remind us as well that in the absence of business being willing to be more transparent and properly self regulate, government will step in. Lastly, they remind us that while trust in governments is not high today, it is nonetheless still

For a version of the above challenges that includes full citations and cross-references, please see the original chapter in the International Handbook on Emerging nanotechnologies.

The Nature Materials commentary can be accessed here.

The concluding chapter of the International Handbook on Regulating Nanotechnologies can be downloaded here.

For further information on The International Handbook on Regulating Nanotechnologies, see here.

[Cross posted from the Risk Science Blog]