Moving policy forward for nanotechnology

Grappling with the appropriate regulatory response to manage new technologies is not a new challenge, though the nature of the risks encountered — and the capacity of our administrative and regulatory arrangements to address them — has changed markedly over the past few decades. Ulrich Beck famously argued that we live in a ‘risk society’, defined as⁷ “a phase of development of modern society in which the social, political, ecological and individual risks created by the momentum of innovation increasingly elude the control and protective institutions of industrial society.” The absence of regulation and risk management frameworks is, therefore, not the problem; rather our existing regulatory arrangements are not always fit for purpose, especially with respect to nanotechnology.

That is not to suggest that regulators have not made significant inroads. There is considerable effort underway among key regulators, notably the US Food and Drug Administration, EU and APVMA, to support the development of the industry without compromising human or environmental health. Nevertheless, although traditional risk management frameworks for agriculture have largely been deemed adequate for the task, there are several characteristics unique to nanotechnologies that need attention⁸. In the first instance, the physical, chemical and biological properties of nanomaterials may differ in important ways from the properties of single atoms, molecules or bulk materials⁴, which makes identifying any direct, indirect and/or cumulative impacts of nanomaterials and nanotechnologies hard to predict. Secondly, the fact that nanoparticles are so small raises concerns about their ability to migrate through organisms and body tissues, which is why the use of nanomaterials in cosmetics, health products, agriculture and food products has been of particular concern for regulators, insurers and consumers^9,10. There are also challenges surrounding the ways in which nanomaterials are manufactured (that is, ‘top down’ or ‘bottom up’), owing to concerns that³ “subtle changes in the method of preparation can lead to significant alterations in the physicochemical properties and morphologies of the resulting nanoparticles.” Such issues are the subject of intense study internationally. For example, the EU-funded project PANDORA (http://www.pandora-h2020.eu) aims to educate young scientists to assess the impact of nanoparticles on the immune and defensive responses of organisms in the environment, including several earth and marine organisms, as well as on humans.

Perhaps most unhelpfully, definitions of what constitutes a nanomaterial or nanotechnology vary from one jurisdiction to another, and from one application to another. In a review of 15 countries, Amenta and colleagues¹¹ found that different regulatory approaches are being followed in OECD and non-OECD countries for the regulation of nanotechnology in the agriculture, food and feed sectors. Globally, only the EU and Switzerland have successfully established legislative provisions specifically for the use of nanotechnology in these sectors, whereas (other) non-EU countries have non-mandatory frameworks and non-legal guidance⁴. In the EU, the primary regulation is the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation, which addresses the use of nanomaterials in plant protection products, food additives/supplements and food contact materials.

Nanotechnology is also highlighting the transaction costs associated with having different regulatory agencies responsible for different applications or uses of a technology. For example, in Australia, three different regulatory agencies — Food Standards Australia New Zealand, the National Industrial Chemicals Notification and Assessment Scheme and APVMA — are all involved in the regulation of nanotechnology in the agriculture and food sectors. Similar administrative arrangements exist in other countries too. Again, this is not a criticism, rather an observation: the need for different regulatory agencies with specific responsibilities and oversight is evident.
 

Five actions to move forward

Robust regulatory systems are the sine qua non of a strong innovation ecosystem: without them, mistakes are made (sometimes catastrophically so) and public confidence in the market erodes. But, as our innovation ecosystem becomes more complex, fast-paced and transboundary, those same regulatory systems must be empowered and sufficiently resourced as to keep up with technology development, consumer expectations and changing environmental and geopolitical conditions.

Build capacity in regulatory agencies

At a very practical level, regulators need access to analytical tools and equipment, trained staff and validated methodologies to accurately identify, quantify and characterize nanomaterials so that they can develop and implement the required regulatory arrangements⁸. Regulatory agencies also need to have the political mandate — and financial and human resources — to work across the vast array of agricultural applications of nanotechnology in the supply chain, and to coordinate activities with counterparts in other jurisdictions¹⁰. Such coordination is easier said than done, not least for the very ‘human’ reason that different regulatory agencies enjoy different cultural norms and practices that can inhibit cooperation. Still, if governments want their investments in science and technology to deliver economic, social and environmental benefits, then it is time regulators are provided with sufficient resources to enable them to generate the robust, agile and connected regulatory frameworks that new scientific frontiers demand.

Acknowledge that people and place matter

We know from our experiences with a range of other new and emerging technologies that perceived risks are as important as real risks in the public’s imagination, and that how science is communicated to the public will affect attitudes. For example, public attitudes may differ according to whether they’re asked about nanodiagnostics, nanosensors and precision farming, as opposed to applications that affect different products, environments and foods. An Australian government survey found that about half of respondents believed that the benefits of nanomaterials outweighed the risks, while another found that the public regarded nanomaterials differently to, and more favourably than ‘chemicals’¹². A US review of nanomaterials had a similar result, finding that the public seemed to be unconcerned about many applications of nanotechnology, except in areas where there is pre-existing social concern, such as with pesticides^13,14,15.

Overall, we have learnt — often the hard way — that different social and cultural contexts produce different attitudes towards new technologies. These differences matter because ‘risk’ and ‘uncertainty’ are not objective and measurable: they are socially constructed and negotiated through political processes^16,17. The onus is on the nanotechnology industry to work closely with governments, NGOs and consumers to understand the concerns of many different communities, so that those concerns can be addressed through context-sensitive regulatory responses. The principles of responsible innovation are germane. However, there are two important lessons here. Firstly, this challenge relates to far more than ‘science communication’. Frontier sciences raise complex questions about people, place, politics, science, technology and society, which demand thoughtful and rigorous responses that social scientists are best placed to interrogate — and there are decades of research to draw on. Secondly, scientists and industry proponents must be prepared to accept the findings from public discourse and deliberation.

Use other new or emerging technologies in the design and delivery of regulation

The dynamism of nanotechnology puts a premium on having up-to-date information at all stages of the technology life cycle. New and emerging technologies could provide regulatory agencies with opportunities to improve the design and delivery of regulation and to work closely with researchers to establish the necessary scientific methodologies and benchmarks. Nanometrology, advanced toxicology, real-time monitoring and reporting, novel civic data collection, and developments in bioinformatics genomics and big data are tools that regulators across the nanotechnology spectrum should explore to address concerns¹⁷.

Intensify efforts towards transnational cooperation

The agriculture and food sectors are highly integrated global industries, so the incorporation of nanotechnology into these sectors demands well-coordinated and meaningful action at the international level. Such transnational cooperation must focus on two challenges. The first is to address the deficit in mature, complete and applied science that can be used to inform regulators’ decisions. For all the reasons described above, there is an urgent need to provide evidence on the potential direct, indirect and cumulative impacts of nanotechnologies in the agriculture and food sectors. The second challenge — which must be pursued in parallel — relates to the regulatory divergence described above. The agriculture and food sectors are already subject to considerable domestic regulation that is designed to protect human and environmental health, but differences in regulatory intent or design between jurisdictions can create barriers to trade¹⁸. The World Trade Organization’s Technical Barriers to Trade Agreement and Sanitary and Phytosanitary Agreement provide the legal framework to minimize those barriers, but agricultural trade remains (for good reason) a highly protected sector. Moving forward, transnational cooperation is required to identify where divergent regulatory approaches can either be harmonized or, ideally, where each regime can ‘mutually recognize’ the other^19,20. Of course, there are existing multilateral, regional and bilateral fora where such cooperation is being sought, for example in the EU and the Asia-Pacific Economic Cooperation, but progress is slow. As part of transnational dialogue and action, the foreign policy and security challenges of nanotechnology must also inform policy frameworks and regulatory responses.

Use all the tools in the regulatory toolbox

Finally, the options available to regulators to identify, assess, manage and mitigate risks has expanded over the past three decades to include three broad categories: traditional ‘command and control’ laws and regulations; market-based or economic regulatory instruments such as cap-and-trade schemes, offsets, taxes and subsidies; and ‘light-handed’ approaches such as eco-labelling and voluntary initiatives^14,17. The extent to which these approaches are successful is the subject of much debate. But, in relation to nanotechnology where regulators cannot hope to keep pace with discovery, it is in all actors’ interests to explore the potential to use the full range of approaches that can collectively offer flexibility, adaptability, relative ease of implementation and the potential for constructive engagement of multiple parties in their design and delivery²¹. For example, Gehrke’s recent study⁹ on the public’s understanding of nanotechnology and tolerance for different regulatory responses puts forward a compelling case that the public’s distrust of companies and governments means they are more favourably predisposed to labelling as a form of regulation, rather than traditional ‘top-down’ regulation. Thus, there may be reasons to explore labelling as a first ‘light-touch’ approach to nanotechnology regulation, while the science matures sufficiently to inform the development of more traditional methods.

Research author contacts: Professor Neena Mitter, Centre Director Horticulture Sciences, Queensland Allaince for Agriculture and Food Innovation, The University of Queensland, E. n.mitter@uq.edu.au and Professor Karen Hussey, Centre Director Centre for Policy Futures, Faculty of Humanities and Social Sciences E. k.hussey@uq.edu.au