Chemistry World posted a good article yesterday on nanotech regulation in Europe (Europe mulls best way to handle nanotech by Andrew Williams).  I have a couple of quotes in the piece, along with Risk Science Center colleague Diana Bowman).  These are taken from a longer set of responses to questions from Williams, which I thought it might be worth posting here (edited slightly so that they make more sense grammatically!)

What are currently the main EU nanomaterial regulations? What are the key elements of these regulations? What is REACH’s (Registration Evaluation Authorization and Restriction of Chemicals regulations) stance as a pan-national regulation on nanomaterials – and is it moving towards the creation of a register?

REACH has deep implications to how chemical substances are assessed and regulated across the European Union, and is impacting on any company either wanting to trade with member states, or manufacture within these states (and so the reach – if you’ll forgive the pun – goes well beyond the EU). Two associated issues here are what constitutes a nanomaterial, and whether the explicit differentiation of nano- and non-nanoscale materials make sense within the context of REACH. The EC Joint Research Council recently published a massive 280+ page document evaluating the previously released definition of nano materials for regulatory purposes – and this is just part one of the definition review process! This document provides a deep and scientifically rigorous assessment of considerations relevant to a definition for regulatory purposes, but is still driven by the assumption that there is something unique about engineered nanomaterial risks that requires them to be distinguished from other materials. I continue to argue that some emerging materials will lead to unanticipated health challenges, but that fixating on the nanoscale potentially blinkers a larger conversation about advanced material safety (latest piece on this).

 

What is the driving force behind these EU and Member State regulatory developments? Who (or what organisations) are proposing them? And what do they hope to accomplish with them?

Current developments arise from a number of trends, influences, factors and concerns. Perhaps at the broadest level, there is a prevailing philosophy in Europe that commerce is important in supporting health and wellbeing within society but that society comes first – which leads to more fertile ground for political discussion and policy around the responsible and cautious development and implementation of new technologies compared to somewhere like the US. This is of course reflected in the use of the precautionary principle in its many guises, which at heart is a “go slow if things look potentially harmful” mechanism designed to reduce the chances of significant adverse impacts on society through lack of foresight or due consideration. On top of this, political groups who advocate for social and environmental good above economic gain have a strong voice in the EU.

Feeding into this has been a combination of legitimate science-based questions around the safety and potential risks associated with emerging nanomaterials, hype around the massive social, environmental and economic impacts of nanotechnology, and remarkably little understanding within decision-making circles on the nature of nanoscale science and engineering and the commercial reality of resulting materials and products. The result has been genuine but ill-formed and ill-conceived questions about policies and regulations to ensure safety. I have a lot of sympathy with people trying to avoid mis-steps here that could lead to harm, as the information and advice they are working from is often confusing and unclear.  There is very little synthesis of current science and understanding that is accessible to policy makers and consumers, and that doesn’t start with the assumption that nanomaterials are uniquely risky.

(as an aside, my stance is that advanced materials engineering and design – across multiple length scales – has the potential to lead to materials that may cause harm in unanticipated and unusual ways. But without a clear perspective on what is likely to present conventional as opposed to unconventional risks, or a similar perspective on which risks are manageable via conventional means as opposed to requiring new approaches, regulators and others run the risk of focusing obsessively on relatively safe materials while missing the really worrying ones when they eventually arrive).

Getting back on track with the question though, given the dogma around the need to act on potential engineered nanomaterial risks, a number of influential organizations are part of EU and international efforts here. Perhaps foremost is the Organization for Economic Cooperation and Development (OECD), where the Working Party on Manufactured Nanomaterials (WPMN) continues to coordinate and lead international efforts to ensure nano material safety. ISO is also working extensively here, and coordinates with OECD. And organizations like WHO also have an interest. These organizations are all doing good work in helping ensure as far as possible decisions on nano material regulation and safety are evidence based.

As to what these organizations and others (including the Green Party, NGOs and trade organizations) hope to achieve – it varies. Organizations with an economic interest want to ensure that they reduce or eliminate product and corporate liability that may arise from actual risks – a vested interest that aligns with ensuring health and well-being. They also want to assuage as far as they can perceived risks, which can hit the economic success of products badly if consumers and citizens loose trust in the product and company. Organizations with a social and environmental agenda want to ensure people and the environment are not adversely affected – and especially that naive decisions are not made now that have long lasting adverse consequences. Then there are groups that have other agendas – such as promoting social and economic justice and challenging current socioeconomic models – and look to leverage issues such as nanotechnology safety to serve these ends.

For the EC though, I suspect the end goal is to ensure long term economic, societal and environmental prosperity by ensuring informed and, where called for, cautious decisions on emerging technologies.

 

Generally speaking, what has been the industry response to these nanomaterial registries? Are there many critics of these registries outside of industry? If so, who? And why?

Industry groups are perhaps the most vocal critics of nanomaterial-related registries, and they primarily have to bear the biggest brunt of the cost associated with the testing and registration, and any resulting impact on product development and sales. There are few other groups that are impacted as deeply financially.

Intellectually, people like myself have questioned the framing of testing materials and collecting information under the banner of nanomaterials. But even here, I would argue that requiring testing and registration of substances that people and the environment are exposed to is important for reducing and managing adverse impacts – the devil however is in the details of how this is done.

 

What is the general point of these registries? Is it to control toxicity? Or to single out nanotechnologies with particular health & safety or environmental impacts?

My understanding is that it is to help document, reduce and manage the risks associated with a specific class of material. The question is – are engineered nanomaterials a class of material that are sufficiently distinct that nano-specific registries make sense.

An argument that is often heard is that materials engineered at the nanoscale behave completely differently to materials not engineered at the nanoscale (novel behavior), and because of this they possibly present risks that are completely different to materials with the same chemical composition – justifying special attention. Unfortunately, the “behave differently” message is somewhat overblown, and even where it is valid for exploitable properties, this does not mean that there are associated novel health and environmental risks. Many economically viable products based on nanoscale science and engineering rely on functionality that arises from sophisticated design and engineering at the nanoscale – sometimes these exploit tunable behaviors of small clusters of atoms and molecules (plasmonics and photonics for example), sometimes they just lead to products that address an opportunity and fill a niche. We’re better at this than we ever have been – but we’ve been doing sophisticated materials science for a century now.

 

Looking ahead – what do you think will be the key trends and developments in nanotechnology/material regulations and registries in Europe over the next few years? Where are all these developments leading?

This is a really tough one. Based on current trajectories, I would expect there to be a consolidation of nanomaterial definitions for regulatory purposes over the next few years, and a greater move toward testing, labeling and cataloging materials that come under the “nanomaterial” umbrella, together with the products that they are used in. I suspect that, despite concerns from some quarters in industry and elsewhere that this is neither justified by scientific understanding or particularly helpful in reducing potential health and environmental impacts, pragmatism will prevail and companies will go along with new nano-specific requirements. I cannot see any indications that there will be significant questioning of these trends leading to a marked change in direction – their is neither the political will or economic value in fighting the current political momentum. And there’s always that lingering doubt that maybe, just maybe, not treating nanomaterials as special will lead to a major incident that could otherwise be avoided.

I do worry though that this trajectory will lock Europe into either a perspective on advanced materials that is so narrow that it misses materials that do present serious potential risks, or a perspective so wide that everything new is consider nano, and therefore worthy of special attention. Neither will be particularly conducive to long term sustainable development that serves economic, societal and environmental needs.