Regulators around the world are currently grappling with how to manage the possible risks associated with first generation nanotechnologies.  But increasingly sophisticated nanotechnology-based products are coming – will the old regulations still cover these emerging nanotechnologies, or is a re-think in how substances are regulated in order?  These are some rough notes I prepared for a short talk given at Chatham House in the UK, on some of the possible challenges to regulating next generation nanotechnologies.

Nanotechnology is oft-heralded as the next industrial revolution—something that will transform our lives.  But despite this lofty vision, many of the nano-driven products that consumers and regulators are grappling with at the moment seem rather mundane.  Nanotechnology promoters talk about smart drugs, super-strong materials and science fiction-like invisibility cloaks. Yet for most people, the nanotechnology of the hear-and-now doesn’t extend much beyond sunscreens and stain-resistant pants.

Okay, so this is something of an oversimplification.  But it’s fair to say that regulatory agencies charged with protecting people and the environment  have so far been faced with rather simple and crude nanotech-enabled products.  These early products of engineering matter at the nanoscale have raised plenty of challenges of their own when it comes to ensuring safe use—like how a material that can cause harm because of its size as well as its chemistry should be regulated, or which of the current battery of toxicity tests applied to new substances work for nanomaterials, and which do not.  However, with some creative thinking, a dash of new research and a bit of hand waving, there’s a general (although by no means universal) feeling that existing regulatory frameworks can just about stretch to cover many of the current products of nanotechnology.

But will this always be the case?

What are the chances of future developments in nanotechnology throwing up products that are so unusual, that existing regulatory frameworks are stressed to the point of breaking?

Looking into the emerging technologies crystal ball is always a dangerous business—there’s often a gaping chasm between the seeds of new technologies and those that eventually make it to market.  Development timescales are inevitably longer than predicted.  And more often than not, the most successful new technologies are the ones that sneak under the radar – taking everyone unawares.

Yet even with these limitations, we probably know enough about where nanotechnology is heading to gain some insight into whether existing regulatory frameworks are likely to suffice, or whether, at some point, new approaches need to be considered.

In tackling the question of future regulatory challenges from emerging nanotechnologies, it seems important to ask “what is different about nanotech?”  It’s where new materials and products deviate from established norms that regulatory frameworks will be most likely be stressed. Some emerging products of nanotechnology will quite conceivably look very conventional from a regulatory perspective – these shouldn’t cause too many problems.  But where a new product’s ability to cause harm doesn’t fit with current understanding, alarm bells should start to ring.

In working out what (if anything) is different about nanotech, there is a tendency to fall back on generally accepted definitions of nanotechnology, such as the one crafted by the US National Nanotechnology Initiative (NNI).  But this is a temptation that needs to be resisted.  The NNI definition of nanotechnology is one of expedience, not science. It serves the purpose of stimulating new research and technology innovation in an exciting new area—and does this brilliantly.  But it doesn’t clearly define a set of products and processes that have common and specific safety issues; and it was never intended to.

Instead, it is more helpful to ask how materials engineered at a nanometer scale might behave differently to more conventional materials, and how this might affect their safe use.

In asking “what is different?” it is useful to distinguish between the intrinsic and extrinsic properties of material that has been engineered at the nanoscale.  In essence, to differentiate between what it is, and what it does. Again, this is something of a simplification, but is useful for getting a handle on what might be important here.

Intrinsic properties can be seen as those that associated with the material itself, rather than how it is being used.  For instance, chemical composition leads to intrinsic properties. Size and shape can also underpin some intrinsic properties.

Some materials begin to show novel intrinsic chemical and biological properties when formed as nanometer-sized particles, or are engineered with nanometer-scale structures.  Some materials that are engineered at the nanometer scale can be used in different ways—and get to different places—simply by nature of their small size – this can also be seen as an intrinsic property of the nano-engineered material.

Much of nanotechnology is about tapping into and exploiting these novel, scale-specific intrinsic properties.

From a regulatory perspective, it becomes important to know when these novel intrinsic properties lead to enhanced or new risks to people and the environment—in other words, when does engineering a substance at the nanoscale leads to a deviation in its conventionally established risk profile?  This is very much the challenge presented by the first wave of engineered nanomaterials that regulators are currently facing.

These challenges are not insignificant.  It is clear that the potential impact from nanomaterials can no longer be predicted by chemistry alone, and regulators are having to adjust to a world where physical form and chemical composition potentially determine risk.  But there are a number of organizations that believe that with the right research, and appropriate interpretation of existing regulations, these challenges are not insurmountable—at least for many types of nanomaterials currently being used.

The situation is not so simple though when it comes to addressing the extrinsic properties of engineered nanomaterials.

But what is the nature of these extrinsic properties?

An important characteristic of nanotechnology is the sophistication it brings to working with matter at the level of atoms and molecules.  Advances in tools and understanding are making it possible to precisely engineer the structure of matter at the finest possible level.  As a result, we are beginning to create materials that are unique—not only do they have properties never before available to scientists, engineers and technologists; they also potentially present human health and environmental risks never before encountered.

This sophistication brings within our grasp the ability to build complex “devices” that are mere nanometers in size.  Using atoms and molecules (or small clusters of them) as our building blocks, we can start to engineer matter at a nanometer scale, and in the words of the late Richard Smalley, “build stuff that does stuff.”

At this point, the extrinsic properties of the “stuff” that we build become critical—the functionality associated with a carefully engineered collection of chemicals and components (what it does) becomes more than just the sum of its parts.

It is these extrinsic properties that may end up stressing established regulatory frameworks to breaking point.

At this point, it is worth clarifying what I mean by “device.”  I’m thinking here of something engineered to do something. From this perspective, a lever or a fork is a simple device.  So is a chair.  Or a car.  At the nanoscale, a device is anything that has been engineered to do something that goes beyond the intrinsic properties of its individual components. So a nanoparticle engineered with just the right size and shape to target and penetrate a tumor is a simple device.  So is a material engineered to bend light or transmit electrons in a specific way.

This is intuitive when working with objects at the human scale.  The difference in functionality between a lump of iron, a knife, and a car, is blindingly obvious.  So are the relative risks.  Once engineered, the extrinsic properties of the resulting device become critical in determining how it is used, and how it might cause harm.

This holds true at the nanoscale as much as it does at the human scale.  But here we face a conceptual hurdle that regulators will need to overcome if the products of emerging nanotechnologies are to be handled safely.  There is a natural tendency to assume that, if we can’t see the physical form and complexity of something, its form and complexity don’t matter.  As a consequence, most substance-related regulations—irrespective of the country or region they apply to—focus on the intrinsic properties of materials—which usually means focusing on their chemical composition.

To be fair, this chemistry world-view has been reasonably effective in reducing the impact of materials on people and the environment over the past fifty years or so.  But nanotechnology is increasingly pushing us into a post-chemistry world, where knowing what something is made of is no guarantee that we know how to handle it safely.

So assuming that nanotechnology is going to lead to increasingly sophisticated materials and “devices” that may present significant challenges to existing regulatory frameworks in the future, do we have an idea of what these emerging technologies will look like?

I’m not sure how far we can predict specific products that are likely to hit the market over the next decade or so.  But it should be possible to get a handle on emerging nanotechnology trends that could help inform future regulatory decisions. Here, the key is sophistication – how will our increasing dexterity at the nanoscale change things?

Mike Roco – one of the instigators of the modern nanotechnology movement –famously mapped out a series of nanotechnology “generations” that try to capture this idea of increasing sophistication.  These progress from passive nanostructures through active nanostructures to systems of nanosystems and molecular nanosystems.  However, as J. Clarence Davies notes in his 2009 report Oversight of Next Generation Nanotechnology,

“Even knowledgeable experts have expressed difficulty distinguishing among Roco’s last three generations and understanding some of the applications he describes.”

An alternative perspective is given by Jim Tour of Rice University, who divides the nano-universe up into passive nanotechnologies, active nanotechnologies and hybrid nanotechnologies.  This is slightly easier to work with than Roco’s “generations,” and makes sense in terms of what increasing sophistication will lead to.

From both of these perspectives, regulators are currently grappling with passive nanotechnologies—simple engineered nanomaterials that may have novel properties which typically do not change according to what is going on around them .  It is the products of these first generation nanotechnologies that are stretching regulations, but apparently not breaking them. However, active nanotechnologies (and beyond) – the nanotechnologies that are just around the corner – are the ones that I suspect are going to require far more thought as to how nano-stuff is regulated in terms of what it does, rather than what it is.

But what exactly is an “active” nanotechnology?

Recently, Vrishali Subramanian at the Georgia Institute of Technology and colleagues took a stab at describing more fully what “active” nanotechnologies are, and came up a scheme that not only makes a lot of sense, but also helps give a feel for what some of the coming next generation nanotechnologies might look like.

Starting from an analysis of the scientific literature between 1995 and 2008, Subramanian came up with five different types of active nanotechnology.  From a regulatory perspective, these are particular useful because they provide a framework for classifying emerging technologies by what they do, rather than what they are.

The five categories she ended up with are:

Remote actuated active nanostructures: Nanotechnologies whose active principle is remotely activated or sensed. In other words, materials or “devices” that are either nano-scale or nano-structured, that change what they do in response to an external signal—a laser pulse say, or a high frequency radio signal.

Environmentally responsive active nanostructures: Nanotechnologies that are sensitive to stimuli like pH, temperature, light, oxidation–reduction, certain chemicals etc.  These are nanomaterials and devices that change what they do according to the environment they find themselves in.  Subramarian gives examples of smart drugs, molecular motors and other devices that respond to changes in their local environment with physical actions.

Miniaturized active nanostructures: Nanotechnologies which are a conceptual scaling down of larger devices and technologies to the nanoscale. This category captures the relatively conventional technologies (including semiconductor electronics and Micro Electrical Mechanical Systems or MEMS – lab-on-a-chip technologies) and how nanotechnology is enabling their construction on an ever-smaller scale.  It also includes the synthesis of new molecules that are designed for a specific purpose—essentially engineering chemistry at the nanoscale.

Hybrid active nanostructures: Nanotechnologies that involve uncommon combinations (biotic–abiotic, organic–inorganic) of materials. These include the fusion of living and non-living systems (biotic-abiotic hybrids) and the interfacing of semiconductors with organic materials.  The resulting technologies not only lead to functional nanoscale devices; they also blur the boundary between biological and non-biological systems.

Transforming active nanostructures: Products of nanotechnology that change irreversibly during some stage of their use or life. These are nanomaterials that undergo a significant change in what they do, and thus might appear as different materials or products, depending on when they are assessed.  Subramanian gives the example of self-healing materials that may undergo a one-off transformation when damaged.

This framework for thinking about emerging nanotechnologies still doesn’t shed too much light on the precise nature of the products regulators are going to be faced with over the coming 5, 10 or 20 years.  But it does underline the shift from nanotechnology products that can be squeezed into an intrinsic properties-based regulatory framework, to those that will almost definitely demand a new way of thinking about potential risks, and how to manage them.

And this brings me back to the question that is central to regulating emerging nanotechnologies effectively – “what is different about nanotech?”  From a risk perspective, there will undoubtedly be new and novel nanotechnologies that do not present unusual regulatory challenges, and it will be important not to fall into the trap of assuming new means different by default.  On the other hand, it does seem that increasingly sophisticated nanotechnologies are going to present a major challenge to regulations that are built on assessing and managing risk associated with what they are made of, rather than what they do.

In the post-chemistry world of nanotechnology, this is a challenge that isn’t going to go away.

End Notes

These notes were prepared for a short talk at the launch of a new report on transatlantic regulation cooperation and nanotechnology, prepared by the London School of Economics, Chatham House, the Environmental Law Institute and the project on Emerging Nanotechnologies.  They are something of a work in progress!

The distinction between intrinsic and extrinsic properties is a useful one I feel for tackling emerging nanotechnologies and potential risks.  But the distinctions probably aren’t as black and white as I infer above – either in terms of the materials and products themselves, or the regulations that are and will be used to ensure their safe use.  Likewise, I suspect that there will be some overlap between the five categories of active nanotechnologies (or more accurately, nanostructures) identified by Subramanian.

Some existing regulations do focus on what a product does, rather than what it is—regulations applying to pharmaceuticals in particular would apply here.  But many of these regulations still come down to characterizing and assessing the product in question in terms of its chemical identity.

Many regulators think that existing regulations are sufficiently robust to cover first generation nanotechnologies.  Not everyone agrees with this perspective though.

And finally, there are moves to work out how to interpret regulations so they are responsive to physical form as well as chemistry – in the US, Europe and elsewhere.  Whether these will simply enable regulations to address first generation nanotechnologies effectively, or whether they will extend to emerging technologies, remains to be seen.