A few weeks ago I spent some time chatting with Howard Lovy for an article for the Nanobusiness Commercialization Association.  That interview was posted by Vincent Caprio on his blog a few days ago, and raised a few eyebrows – was I showing signs of becoming a nano-risk skeptic?

I hope not, as as I still feel emerging evidence and trends indicate major perceived and real risk-related barriers lie in the path of developing nanoscale science and engineering successfully, if we aren’t smart.  But I have always adhered to the idea that successful and responsible technology development depends on taking an evidence-based approach – even if that evidence is sometimes uncomfortable.  And so these days I sometimes worry that too much is made of artificial constructs surrounding “nanotechnology”, and not enough is made of the underlying science.

Reading through Howard’s piece, I felt it was a pretty accurate reflection of our conversation.  There are a couple of places where it possibly indicates less concern on my part than is warranted.  Toward the end of the piece for instance I am quoted as saying “there is no need [for the nanobusiness community] to respond to individual challenges such as this lawsuit against the FDA”, referring to a recent lawsuit by consumer advocates against the U.S. Food and Drug Administration, which claims the FDA is failing to regulate nanomaterials in products.

I’m pretty sure I did say something along these lines.  But the context was that lawsuits like these are a relatively widely used mechanism for holding federal agencies to account and prodding them into action.  And while they are often important, the nanobusiness community need to understand this context and be aware of the bigger picture when it comes to responsible and sustainable development.

Overall though, the piece captures my increasing interest in getting to the bottom of what can go wrong as new technologies are developed, and how we need to start exploring better ways of ensuring responsible innovation.

Here’s the piece that Howard wrote – the original can be read on Vincent Caprio’s blog Evolving Innovations.

When Andrew Maynard, director of the Risk Science Center at the University of Michigan, read the text of a recent lawsuit by consumer advocates against the U.S. Food and Drug Administration, which claims the FDA is failing to regulate nanomaterials in products, one phrase jumped out at him. The groups used the words “fundamentally unique properties” when referring to nanoscale ingredients.

The phrase, in fact, comes directly from marketing material of the National Nanotechnology Initiative. So, in one sense, the nanotech industry is a victim of its own public relations, Maynard believes. A phrase used to promote nanotech commercialization is being thrown back at nanotech advocates by those who would use the same logic to demand strict regulations.

“There is an assumption that you can have everything your own way,” Maynard says. “You can say something was unique and important and world-changing, selling the hype, and yet not really understanding what the long-term consequences of that hype are.”

This is what Maynard does for a living. He tries to reach beyond hype and beyond gloom to assess and communicate the real risks associated with emerging technologies, including nanotechnology. But he approaches these assessments from a starting point that seems increasingly difficult to achieve in these polarized political times – one based on scientific principles rather than political agenda.

The problem with that “unique properties” phrase that has been so misused over the years is that the science does not necessarily back it up. Material at the nanoscale is not necessarily any different from its macroscale cousin.

“Now, with the research that’s been generated in the last few years, it’s become increasingly clear that there’s no well-defined set of materials that raise red flags when it comes to size,” Maynard says. “About the best you can do is say that the smaller and more sophisticated you make things the more you have to think about a wide range of questions when you’re evaluating safety.”

So, when Maynard now discusses nanotechnology and potential risk, he’s not likely to even use the “n” word. He’s talking about advanced materials, or “sophisticated materials.”

For example, he says, what questions do you ask when trying to determine whether quantum dots are safe? Well, you talk about the composition of the quantum dot, how its physical and chemical structure determines how it interacts with biological systems, and how its size effects where it goes in the body and how it interacts within it.

“But those are not nano-specific questions,” he says. “They’re the questions associated with a specifically designed material.”

The same thing with titanium dioxide found in sunscreens. Shrink them down to nanosize and you get concerns raised by advocacy groups such as the Friends of the Earth and others involved in the lawsuit against the FDA, but the research says titanium dioxide, even at that size, is still pretty benign.

It has taken Maynard a few years to reach this point in his thinking about nanotech. Many in the nanotech business community might remember Maynard when he was scientific adviser for the Wilson Center’s Project on Emerging Nanotechnologies (PEN) between 2005 and 2008. The PEN raised many questions about the potential risks of nanomaterials. Has he changed since his Wilson Center days?

“I have, which is I think inevitable. If you take a young field, our knowledge is going to change over time,” Maynard says. “And if we don’t change our opinions based on that knowledge there’s something wrong.”

But one thing that has not changed is his belief that if nanotech is going to develop into a sustainable industry that is economically robust, it needs to also be “socially robust” and develop with an eye toward social implications.

“It makes a lot of business sense, if you’re developing any new technology – not just nanotech or whatever – to be aware of the possiblities of what might go wrong with that technology and those products and shore things up as early as possible,” he says.

The problem, though, is that roughly 10 years after these questions were first asked, after the U.S. government has invested millions in looking at the environmental and health implications of nanotechnology, we still are not much wiser.

“We know a lot more now,” Maynard says. “The question is do we know a lot more that’s useful now. That’s what I would debate.” The problem, he says, is that the wrong questions are being asked.

Take, for example, carbon nanotubes. There is an assumption by many researchers, Maynard said, that the material is similar to asbestos. But nanotubes are not straight, long, rigid fibers, yet this assumption is driving the research.

“I am quite often concerned that you talk to toxicology groups doing research on carbon nanotubes, I don’t think many of them could actually accurately describe to you the physical form or nature of a carbon nanotube. And yet they’re doing research under various assumptions of what these things are like.”

So, this is the mission of Maynard’s Risk Science Center – to start discussions about the risks of technology with a grounding in real science and not on speculation, taking and “evidence-based approach.”

He’s come a long way since the early 1990s, Maynard, now 46, worked on his Ph. D. at Cambridge in the UK, using advanced microscopy techniques to analyze airborne particles. At the time, many of his colleagues told him he was wasting his time. There would be no future in tiny materials. They were wrong, of course, and Maynard got involved further and further into studying emerging technologies. Eventually, he made the jump from doing science to studying the proper ways of communicating it to the public.

Next on his agenda is looking at issues involved in advanced manufacturing, which overlaps with nanotech. Again, he said he is asking questions having to do with how businesses using new manufacturing technologies, producing new materials, can predict where economic and social barriers are going to be and have a plan to get over them. That includes codes of conduct, standards and best practices. It is up to the industry, itself, to make sure these are in place. The alternative is unwanted regulation.

The most-important advice Maynard gives to the nanotech business community is to simply be aware of the possible implications of the technology they’re developing and make sure regulatory agencies are properly informed of what is being done. But there is no need to respond to individual challenges such as this lawsuit against the FDA.

“It’s worthwhile playing the long game and not being too reactionary to what happens,” Maynard says. “What’s happened over the last 10 years is that concerns over nanotechnology really haven’t gained that much traction.”

In fact, it’s just the opposite. People, in general, remain excited about the prospects of nanotechnology.

“I think the bottom line is to be as honest as possible, and talk to people,” Maynard says. “One of the biggest problems is if you come across as trying to hide things or trying to obscure things. Generally, people are really excited about this technology. They just want to know what’s going on. They want to know what it’s about.”

For more on where my thinking is going on sophisticated materials, check out:

Maynard, A. D., Philbert, M. A. and Warheit, D. B. (2011) The New Toxicology of Sophisticated Materials: Nanotoxicology and Beyond. Toxicol. Sci. 120 (suppl 1): S109-S129. [Free download]

Maynard, A. D. (2011) Don’t Define Nanomaterials. Nature 475, 31 [Accessible here]

Maynard, A. D., Bowman, D., Hodge, G. (2011) The problem of regulating sophisticated materials. Nature Materials 10, 554–557 [Accessible here]

The European Commission had just adopted a “cross-cutting designation of nanomaterials to be used for all regulatory purposes” (link). The definition builds on a draft definition released last year, but includes a number of substantial changes to this.

Here’s the full text of the definition:

1. Member States, the Union agencies and economic operators are invited to use the following definition of the term “nanomaterial” in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies.

2. “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

4. For the purposes of point (2), “particle”, “agglomerate” and “aggregate” are defined as follows:

(a) “Particle” means a minute piece of matter with defined physical boundaries;

(b) “Agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;

(c) “Aggregate” means a particle comprising of strongly bound or fused particles.

5. Where technically feasible and requested in specific legislation, compliance with the definition in point (2) may be determined on the basis of the specific surface area by volume. A material should be considered as falling under the definition in point (2) where the specific surface area by volume of the material is greater than 60 m2 / cm3. However, a material which, based on its number size distribution, is a nanomaterial should be considered as complying with the definition in point (2) even if the material has a specific surface area lower than 60 m2/cm3.

6. By December 2014, the definition set out in points (1) to (5) will be reviewed in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased.

7. This Recommendation is addressed to the Member States, Union agencies and economic operators.

Particular points of interest here include:

1.  The inclusion of incidental and natural materials in the definition.  The inference is that any product containing or associated with nanomaterials from any of these sources will potentially be regulated under this definition.  Strict enforcement of this definition would encompass many polymeric materials and most heterogeneous materials currently in use.  And the lack of distinction between “hard” and “soft” nanoparticles means that the definition applies to any substance containing small micelles or liposomes – someone needs to check the micelle size distribution in homogenized milk.

2.  The focus on unbound nanoparticles and their agglomerates and aggregates.  This makes sense in terms of targeting materials with the greatest exposure potential.  But it may be hard to apply to complex nanostructured materials which nevertheless present unusual health and environmental risks – such as materials with biologically active structures that are not based on unbound nanoparticles (patterned surfaces, porous materials and nano-engineered micrometer-sized structures come to mind).

3.  The threshold of 50% of a material’s number distribution comprising of particles with one or more external dimension between 1 nm – 100 nm.  This is a laudable attempt to handle materials comprised of particles of different sizes.  But it is unclear where the scientific basis for the 50% threshold lies, how this applies to aggregates and agglomerates, and how diameter is defined (there is no absolute measure of particle diameter – it depends on how it is defined and measured).

4.  The “grandfathering” in of materials such as fullerenes, graphene flakes and carbon nanotubes with one or more dimensions below 1 nm.  This makes little sense – carbon 60 fullerenes are around 1 nm in diameter, and single walled carbon nanotubes typically have a lower diameter just above 1 nm.  Unless this is a typo, and should have read “100 nm”.  Surely not.

This seems very much like a definition of convenience – and one that I worry will detract from developing evidence-based regulation (see my previous comments on this).  Of course, the critical question is, how will the definition be used.  According to the EC,

Nanomaterials are not intrinsically hazardous per se but there may be a need to take into account specific considerations in their risk assessment. Therefore one purpose of the definition is to provide clear and unambiguous criteria to identify materials for which such considerations apply. It is only the results of the risk assessment that will determine whether the nanomaterial is hazardous and whether or not further action is justified.

In other words, there is no clear evidence of risk here, but provisions are being made to regulate a notional class of materials, just in case evidence should indeed emerge.

The desire to identify materials that require further action makes sense.  But I do worry that this definition is a significant move toward requiring industry action and providing consumer information in a way that creates concern and raises economic barriers, without protecting health (and possibly taking the focus off materials that could present unusual risks) – in the “do no harm” and “do good” stakes, it seems somewhat lacking.

It’s been a while in the making, but with a little under five weeks to go, we have just posted the final program for the 2011 Risk Science Symposium (20-21 Sept).  And even though I say so myself, it’s a doozy!

Somehow, we are squeezing 45 invited speakers into the two days, and not any old speakers – the lineup includes John Viera – Ford Motor Co. Director of Sustainability Environment and Safety Engineering; Ray O. Johnson,  Senior Vice President and Chief Technology Officer of Lockheed Martin Corporation; Brian Ivanovic, Senior Vice President of Swiss Re; and Paul Anastas, Assistant Administrator for the Office of Research and Development and Science Advisor to the EPA.  And that’s just for starters.  We also have experts in innovation, policy, communication end engagement, risk, governance and sustainability.  We even have two leading designers from the company IDEO.

It’s going to be quite a party!

For more information on the speakers, check out the symposium website.  I’ve posted the program below, because I’m so excited about it, but you can also access it here.

The symposium is being held in Ann Arbor MI between Sept 20-21.  There are still a few spaces left, but we are nearing capacity – so if you are thinking of coming, it’s worth registering sooner rather than later.

________________________________________________________

September 20 – The benefits and challenges of technology innovation

7:30 AM Continental Breakfast and Registration

9:00 AM Welcome and Introductions
Andrew Maynard, Director, University of Michigan Risk Science Center

9:15 AM Opening Address
Martin Philbert, Dean, University of Michigan School of Public Health

9:30 AM Keynote: Innovate or perish – Why innovation and sustainability are critical to economic and social growth in the 21st century.
John Viera, Director of Sustainability Environment and Safety Engineering, Ford Motor Co.

10:00 AM Panel: What keeps us awake at night? The risks of getting technology innovation wrong.
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center
Panel Members:

• John Viera, Director of Sustainability Environment and Safety Engineering, Ford Motor Co.
• R. Alta Charo, Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin
  
• Greg Bond, Corporate Director of Product Responsibility, Dow Chemical Company
  
• Hilary Sutcliffe, Director, MATTER
  

10:45 AM Break

11:15 AM Panel: Techno-hype or techno-reality – are we on the cusp of a new era in the history of human innovation?
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center
Panel members:

• Mark Banaszak Holl, Associate Vice-President, Office of Vice President for Research, University of Michigan
• Thomas Zurbuchen, Associate Dean for Entrepreneurial Programs, College of Engineering, University of Michigan
• Paula Olsiewski, Program Director, Alfred P. Sloan Foundation
• James Bagian, Director of the Center for Healthcare Engineering and Patient Safety; Professor in the Medical School and the College of Engineering, University of Michigan
  

12:00 PM Panel: How are new technologies changing the world, and what are some of the key emerging risk-related opportunities and challenges?
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center
Panel members:

• Gil Omenn, Professor of Internal Professor of Internal Medicine, Human Genetics, and Public Health and Director of the Center for Computational Medicine & Bioinformatics and the Proteomics Alliance for Cancer Research, University of Michigan
• James Baker, Ruth Dow Doan Professor of Medicine and Bioengineering, Director of Michigan Nanotechnology Institute for Medicine
• Ann Marie Sastry, Arthur F. Thurnau Professor of Mechanical, Biomedical and Materials Science and Engineering, University of Michigan; CEO and Co-Founder of Satki3
• Jörg Lahann, Associate Professor of Chemical Engineering, University of Michigan

12:45 PM Lunch and poster session

2:00 PM Panel: New technologies – new risks? What are the implications of a technologically complex world on the way we think about risks of novel technologies and practices?
Moderator: Shobita Parthasarathy, Associate Professor, Ford School of Public Policy
Panel members:

• Paul Anastas, Assistant Administrator for the Office of Research and Development. Science Advisor to the EPA
  
• Mark Banaszak Holl, Associate Vice-President, Office of Vice President for Research, University of Michigan
  
• David Goldston, Director, Government Affairs, Natural Resources Defense Council
  
• Jameson Wetmore, Assistant Professor, Arizona State University

2:45 PM Panel: The risk toolbox: What are we good at, and what do we need to learn to do better?
Moderator: Martin Philbert, Dean, University of Michigan School of Public Health
Panel members:

• Adam Finkel, Executive Director, Penn Program on Regulation
• Bernard Goldstein, Professor of Environmental and Occupational Health, University of Pittsburgh Graduate School of Public Health
• Jo Anne Shatkin, CEO, CLF Ventures
• Carlos Peña, Director of Emerging Technology Programs in the Office of the Chief Scientist, Office of the Commissioner, FDA

3:30 PM Break

3:45 PM Panel: Innovation, uncertainty and risk: Reflections on the day’s discussions
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center

• David Bidwell, Research Fellow, University of Michigan, Serving as program manager for the Great Lakes Integrated Sciences and Assessments Center (GLISA)
• Diana Bowman, Assistant Professor, Department of Health Management Policy, University of Michigan School of Public Health
• Erica Blom, PhD Candidate in Sociology and Public Policy, University of Michigan
• Ahleah Rohr, Masters of Public Health student, University of Michigan

4:30 PM Adjourn

6:00 PM Reception and Dinner (University of Michigan Art Museum)
Dinner speaker: Rodrigo Martinez, Life Sciences Chief Strategist, IDEO. Mark Jones, Associate Partner and Service Innovation Lead, IDEO.

9:00 PM End of day

September 21 – Risk, Uncertainty and Sustainable Innovation – Exploring options

7:00 AM Continental Breakfast

8:00 AM Welcome and introductory remarks

8:15 AM Keynote: Thinking differently about Risk, Innovation and Sustainability
David Zaruk, Risk Governance Analyst, Risk Perception Management

8:45 AM Panel: Ensuring sustainable innovation-based solutions to global issues – how significant are risk and uncertainty, and how should we handle them?
Moderator: Don Scavia, Director, University of Michigan Graham Environmental Sustainability Institute
Panel members:

• Ray O. Johnson, Senior Vice President and Chief Technology Officer, Lockheed Martin Corporation
  
• James Wilsdon, Director, Royal Society Science Policy Centre
  
• Greg Bond, Corporate Director of Product Responsibility, Dow Chemical Company
• Paul Anastas, Assistant Administrator for the Office of Research and Development. Science Advisor to the EPA
  

9:30 AM Panel: Thinking differently about risk and sustainability I: How can we manage emerging health risks more proactively?
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center
Panel members:

• Brian Ivanovic, Senior Vice President, Swiss Re
• R. Alta Charo, Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin
• Larisa Rudenko, Director of Animal Biotechnology, Center for Veterinary Medicine, FDA
• Adam Finkel, Executive Director, Penn Program on Regulation

10:15 AM Break

10:30 AM Panel: Thinking differently about risk and sustainability II: Are there new models we should be exploring?
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center
Panel members:

• Bernard Goldstein, Professor of Environmental and Occupational Health, University of Pittsburgh Graduate School of Public Health
• Dan Greenbaum, President, Health Effects Institute
• Brian Ivanovic, Senior Vice President, Swiss Re
• John Viera, Director of Sustainability Environment and Safety Engineering, Ford Motor Co
• David Zaruk, Risk Governance Analyst, Risk Perception Management

11:15 AM Panel: Ubiquitous Monitoring and Risk: What are the implications for Public Health and Sustainability?
Moderator: John Stone, Co-Director, Center for the Study of Standards in Society, Michigan State University
Panel members:

• Lawrence Busch, University Distinguished Professor of Sociology and founder and former
  Director of the Center for the Study of Standards in Society at Michigan State University
  
• John Spink,Assistant Professor and Associate Director for the Anti-Counterfeit and
  Product Protection Program, Michigan State University
  
• Kyle Powys Whyte, Assistant Professor of Philosophy and affiliated faculty at the Center for the Study of Standards in Society, the Peace and Justice Studies Specialization, and the American Indian Studies Program

12:00 PM Lunch, followed by keynote presentation

12:30 PM Keynote: Technology innovation, risk and policy in the 21st century – a UK perspective.
James Wilsdon, Director, Royal Society Science Policy Centre

1:15 PM: Panel: What are the roots of risk perceptions and what are their implications for forward-thinking approaches to addressing risk?
Moderator: Andrew Maynard, Director, Universiry of Michigan Risk Science Center
Panel members:

• Brian Zikmund-Fisher, Assistant Professor, Health Behavior and Health Education, Research Assistant Professor, Internal Medicine, University of Michigan
  
• Julie Downs, Director of the Center for Risk Perception and Communication. Social and Decision Sciences at
  Carnegie Mellon University
  
• Michael Siegrist, Professor for Consumer Behavior Institute for Environmental Decisions (IED), ETH Zurich, Switzerland

2:00 PM Panel: Risk, uncertainty and social engagement – how can we do better?
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center
Panel members:

• Britt Erickson, Senior editor in the government and policy group Chemical & Engineering News
• Larry Bell, Senior Vice President – Strategic Initiatives, Museum of Science, Boston. Director of the Nanoscale
  Informal Science Education Network
• Rae Ostman, Director of National Collaborations, Sciencenter, NY
  
• Hilary Sutcliffe, Director, MATTER

2:45 PM Moving forward, what are what are the most important next steps to ensuring healthy lives and a growing economy through technology innovation?
Moderator: Andrew Maynard, Director, University of Michigan Risk Science Center

3:15 PM Close of symposium

]]> http://2020science.org/2011/08/19/final-program-posted-for-the-risk-uncertainty-and-sustainable-innovation-symposium/feed/ 0 http://2020science.org/2011/07/22/seven-challenges-to-regulating-sophisticated-materials/ http://2020science.org/2011/07/22/seven-challenges-to-regulating-sophisticated-materials/#comments Fri, 22 Jul 2011 14:23:11 +0000 Andrew Maynard http://2020science.org/?p=4263

The materials that most current regulations were designed to handle are pretty simple by today’s standards. Sure they can do some nasty things to the environment or your body if handled inappropriately. And without a doubt some of the risks associated with these “simple” materials are not yet well understood – especially when it comes to long term and trans-generational impacts.

Yet it’s hard to escape that reality that researchers are now designing new materials from the ground up that behave in novel ways, that have few analogs in the world of conventional materials, and that exhibit different properties according to the environment they are in. And as they do, it is becoming increasingly apparent that many of the regulations we rely on are ill-equip them to deal with the pending flood of sophisticated materials that is coming our way.

The development of relatively simple engineered nanomaterials in recent years has highlighted this disconnect between established regulations and the new demands being placed on them. Fortunately, many of the first nanomaterials to emerge have not presented insurmountable challenges, and regulators have been able to stretch existing regulatory frameworks to cover them (although even this in itself has not been an easy task). But these are just the beginning of a trend in novel materials designed and engineered at the nanoscale that will transcend current regulatory mindsets.

So what what are the options here? Before this question can be answered, a clearer understanding of the issues being faced needs to be developed.

Some of these are explored by Graeme Hodge, Di Bowman and myself in a commentary in the August 2011 edition of the journal Nature Materials.

“The problem of regulating sophisticated materials” [DOI: dx.doi.org/10.1038/nmat3085 - paywall] explores issues surrounding the safe introduction and use of complex new materials such as engineered nanomaterials, and suggests that there are seven key regulatory challenges that need to be addressed for progress to be made.

Unfortunately, I can’t reproduce the commentary in full here because of copyright restrictions. However, much of it draws on and builds upon an analysis presented in the recent International Handbook on Regulating Nanotechnologies.

What I thought it would be useful to do here is to summarize the seven challenges discussed in both the Handbook and the Nature Materials commentary. These are summarized from the final chapter of the Handbook (the full chapter can be downloaded here) – further information can be found both in the Handbook chapter and in the Nature Materials Commentary.

One of the problems with publishing in journals like Nature is that it can get a little pricey for people to read your work if they (or their organization) don’t subscribe.  For instance, if you want to read the commentary I’ve just had published on defining engineered nanomaterials for regulatory purposes, you are facing a hefty $32 fee to push through the paywall.  Now I know that I write interesting stuff.  But I’m not sure it’s that interesting!

Which is why I have just posted an earlier draft of the piece over on the Risk Science Blog.

This isn’t as focused or specific as the published commentary.  But it gives a rough idea of where I’m coming from.

And just because I can, I have also posted link to a later draft, and some notes on the editing process – so that those of you with more time than  sense can study in depth the evolution of the piece from initial scribblings to final product!

The early draft can be read here, and the published commentary “Don’t define nanomaterials” (Nature 475, 31 2011) can be accessed here.

It must be Nanotechnology Regulation week in Washington DC.  Yesterday, two federal agencies and the White House released documents that grapple with the effective regulation of products that depend on engineered nanomaterials.

In a joint memorandum, the Office of Science and Technology Policy, the Office of Management and Budget and the Office of the United States Trade Representative laid out Policy Principles for the U.S. Decision Making Concerning Regulations and Oversight of Applications of Nanotechnology and Nanomaterials.

On the same day, the US Environmental Protection Agency posted a prepublication notice on Policies Concerning Products Containing Nanoscale Materials.

And to cap it all, the US Food and Drug Administration released Draft Guidance for Industry on Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.

A busy week for nanotechnology regulation!

White House Memo on Nanotechnology Regulation Policy Principles

The White House memorandum is the latest document to come out of the Emerging Technologies Interagency Policy Coordination Committee – ETIPC for short.  In part, it is a response to the 2010 review of the National Nanotechnology Initiative by the President’s Council of Advisors on Science and Technology, and in particular the concern expressed by PCAST that

“In the absence of sound science on the safe use of nanomaterials and of technologies and products containing them, the chance of unintentionally harming people and the environment increases.  At the same time, uncertainty and speculation about potential risks threaten to undermine consumer and business confidence.”

Correspondingly, this is a memorandum that is heavily focused on science-driven regulation, and the avoidance of knee-jerk responses to speculative concerns.

Reading through it, a number of themes emerge, including:

• Existing regulatory frameworks provide a firm foundation for the oversight of nanomaterials, but there is a need to respond to new scientific evidence on potential risks, and to consider administrative and legal modifications to the regulatory landscape should the need arise.
• Regulatory action on nanomaterials should be based on scientific evidence of risk, and not on definitions of materials that do not necessarily reflect the evidence-based likelihood of a material causing harm.
• There should be no prior judgement on whether nanomaterials are intrinsically benign or harmful, in the absence of supporting scientific evidence.
• Transparency and communication are important to ensuring effective evidence-based regulation.

Overall, this is a strong set of policy principles that lays the groundwork for developing regulation that is grounded in science and not swayed by speculative whims, and yet is responsive and adaptive to emerging challenges.  Gratifyingly, the memorandum begins to touch on some of the concerns I have expressed previously about approaches to nanomaterial regulation that seem not to be evidence-based.  There is a reasonable chance that they will help move away from the dogma that engineered nanomaterials should be regulated separately because they are new, to a more nuanced and evidence-based approach to ensuring the safe use of increasingly sophisticated materials.  Where it perhaps lacks is in recognizing the importance of other factors in addition to science in crafting effective regulation, and in handling uncertainty in decision making.  But it is undoubtedly a move in the right direction.  The principles are listed at the end of this post.

EPA Draft Pesticides and Nanomaterials Policies

The second piece in this triumvirate is a prepublication version of a document from EPA that should appear in the Federal Register next week, titled “Pesticides; Policies Concerning Products Containing nanoscale Materials; Opportunities for Public Comment.”

As the title makes very clear, this is a statement from the EPA that is setting out draft policies for dealing with nanomaterials in pesticide products – materials such as nanoscale silver particles – and asking for public comment.  This is the latest iteration in a process that has been going on for some time to address the use of nanoscale silver as an antimicrobial agent, together with other antimicrobial, fungicidal and pesticide uses of nanomaterials.

The crux of the proposed policy is a requirement for manufacturers to let EPA know when a pesticide product contains an engineered nanomaterial – irrespective of whether it is an active or passive ingredient in the product. EPA acknowledges that the presence of a nanoscale material in a product does not necessarily indicate the possibility that it will exhibit new or unusual risks – but the agency intends to use this information as a trigger for a more thorough evaluation of products that might raise concerns.

This is a long and somewhat convoluted document, that spends some time outlining what the agency considers is an engineered nanomaterial, and reviewing nanomaterial hazard data.

Reading the document, EPA still seems somewhat tangled up with definitions of engineered nanomaterials. After outlining conventional attributes associated with engineered nanomaterials, including structures between ~1 – 100 nm and unique or novel properties, the document states

“These elements do not readily work in a regulatory context because of the high degree of subjectivity involved with interpreting such phrases as “unique or novel properties” or “manufactured or engineered to take advantage of these properties” Moreover the contribution of these subjective elements to risk has not been established.”

This aligns with where my own thinking has been moving in recent years.  Yet following this statement, the document reverts back to considering nanoparticles between 1 – 100 nm as the archetypal nanomaterial, and intimates “novel” properties such as “larger surface area per unit volume and/or quantum effects” as raising new risk concerns.

I also found the background information on potential hazards somewhat lopsided, as a litany of studies were cited that indicate a number of potential hazards associated with a range of materials, but without clear information on how this might translate to plausible and quantifiable risk.

At the end of the day, I found this to be a mixed bag of a document – some useful information and some evidence of new thinking, but all surrounded by a rather unfocused assessment.   However, it is a draft that has been put out for public comment, which means that there is an opportunity here to tighten it up considerably in the final version.

I must also add that I was impressed by the final section on Questions for Comment – here you will find a list of highly relevant questions that are the clearest indication in the document that EPA understands many of the critical issues here, and is genuinely looking for expert input to address them.

Interestingly though, the EPA document does not reference the White House memorandum on Policy Principles published at the same time – unlike my third and final document in this set from FDA.

FDA Draft Guidance for Industry on Products and Nanotechnology

The FDA Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology is a very different kettle of fish to the EPA document.  It is overtly responsive to the White House memo; it demonstrates a deep understanding of the issues surrounding nanotechnology and regulation; and it is mercifully concise.

To be fair, the scope of the draft guidance is limited to helping manufacturers understand how the agency is approaching nanotechnology-enabled products under their purview.  But this is something it does well.

One of the more significant aspects of the guidance is the discussion on regulatory definitions of nanomaterials.  Following a line of reasoning established some years ago, the agency focuses on material properties rather than rigid definitions:

“FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms… Based on FDA’s current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit”

Of course, this still begs the question “what is a nanomaterial in FDA’s eyes?”  The agency answer by stating:

At this time, when considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology, FDA will ask:

1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
2. Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

The guidance goes on to state

“These considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. Additionally, they are subject to change in the future as new information becomes available, and to refinement in future product-specific guidance documents.”

FDA is clearly aiming for responsive and adaptive regulation here.

Reading the first of the two criteria above and the associated justification in the guidance, I can’t help feeling that FDA is still trying to justify responding to sub-100 nm scale materials based on assumptions of risk rather than evidence.  But the second criteria is important, because it opens the door to considering physical form and structure as a factor in determining potential risk irrespective of scale – as long as a material can come into intimate biological contact with a person.  This is a significant move, as it supports evidence-based decision-making on materials and products under FDA’s jurisdiction, irrespective of what technological label is applied to them.

That said, there remains some confusion as to how this criteria will be applied, and the reasoning behind it. Clearly, there is an aim here to capture supra-100 nm materials that nevertheless exhibit biological behavior associated with a nanometer-scale structure – including agglomerates, coated materials and hierarchical structures.  Yet the criteria is also said to have been selected to “exclude macro-scaled materials that may have properties attributable to their dimension(s) but are not likely relevant to nanotechnology”.  This statement seems to hark back to an assumption that “nanotechnology” is something that needs to be regulated, rather than focusing on materials and products that run the risk of slipping through the regulatory net – no matter what they are called.

But like the EPA document, the FDA guidance is still in draft form, and open to public comment.  And so is still very much a work in progress.

Overall, all three of these documents seem to be heading in the right direction if evidence-based, responsive and responsible regulations are the end goal.  There is still a way to go for both FDA and EPA before regulatory policy escapes being mesmerized by “nanotechnology”. But with strong science-driven policy principles emerging from the White House, the odds of this occurring are looking decidedly more healthy.

_____________

While House Policy Principles for the U.S. decision-Making Concerning Regulation and Oversight of Applications of nanotechnology and Nanomaterials:

In addressing issues raised by nanomaterials, agencies will adhere to the Principles for Regulation and Oversight of Emerging Technologies. Specifically, to the extent permitted by law, Federal agencies will:

• To ensure scientific integrity, base their decisions on the best available scientific evidence, separating purely scientific judgments from judgments of policy to the extent feasible;
• Seek and develop adequate information with respect to the potential effects of nanomaterials on human health and the environment and take into account new knowledge when it becomes available;
• To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), develop relevant information in an open and transparent manner, with ample opportunities for stakeholder involvement and public participation;
• Actively communicate information to the public regarding the potential benefits and risks associated with specific uses ofnanomate rials;
• Base their decisions on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making;
• To the extent practicable, provide sufficient flexibility in their oversight and regulation to accommodate new evidence and learning on nanomaterials;
• Consistent with current statutes and regulations, strive to reach an appropriate level of consistency in risk assessment and risk management across the Federal Government, using standard oversight approaches to assess risks and benefits and manage risks, considering safety, health and environmental impacts, and exposure mitigation;
• Mandate risk management actions appropriate to, and commensurate with, the degree of risk identified in an assessment.
• Seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with nanomaterials; and
• Encourage coordinated and collaborative research across the international community and clearly communicate the regulatory approaches and understanding of the United States to other nations.

Cross-posted from The Risk Science Blog:

Back in 2007 the White House Office of Science and Technology Policy (OSTP) issued a set of “Principles for Nanotechnology Environmental, Health and Safety Oversight” (no longer available on the OSTP website it seems, but you can read them in this Nanowerk article). At the time, I was less than enamored with the “don’t mess with business” tone of the principles. So I was particularly interested to read what the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) had to say on a very similar issue last month.

ETIPC was formed last year, and consists of assistant secretary-level representation from about twenty federal agencies. From the White House blog, the group is

…part of an effort to give special attention to technologies so new—such as nanotechnology and synthetic biology—that their policy implications are still being gauged. Created jointly by OSTP, the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA), and the Office of the United States Trade Representative (USTR), the ETIPC consists of assistant secretary-level representatives from about 20 Federal agencies.

The same post goes on to explain that

Emerging technologies promise to have significant scientific, economic, and perhaps societal impacts because of their potential to revolutionize fields as varied as materials science, electronics, medicine, communications, agriculture, and energy. Rapid scientific and technological advances in these fields are resulting in a variety of new products and processes with unique and transformational characteristics. But full realization of the economic and public benefits of these applications will require open consideration of policy questions with the full range of stakeholders, including governments, industry, non-governmental organizations, academia, and the public.

The first publicly released outcomes of ETIPC were released last month. On March 11 2011, John Holdren (Director of OSTP and Assistant to the President for Science and Technology), Cass Sunstein (Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget) and Islam Siddiqui (Chief Agricultural Negotiator, United States Trade Representative) issued a joint memorandum on Principles for Regulation and Oversight of Emerging Technologies, developed by ETIPC.

These are consistent with the President’s Executive Order 13563 (issued on January 18 2011) on Improving Regulation and Regulatory Review. They also include much of the same language of the 2007 principles. But the tone and emphasis are markedly different.

The memorandum starts by noting that

Innovation with respect to emerging technologies — such as nanotechnology, synthetic biology, and genetic engineering, among others — requires not only coordinated research and development but also appropriate and balanced oversight.

It then frames the issues at stake by stating:

We share a fundamental desire for regulation and oversight that ensure the fulfillment of legitimate objectives such as the protection of safety, health, and the environment. Regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.

This is in stark contrast to the 2007 principles, which have a much stronger primary focus on not intrfereing with business and innovation.

The principles follow up this focus on safety, health and the environment with an emphasis on science-based decision-making, public participation, and flexibility. These reflect emerging thinking on the challenges and opportunities presented by emerging technologies, and appear to offer a firm foundation for moving forward.

However, reading the principles (which are included below) I do have a couple of concerns.

The first is that these principles are extremely general. While establishing laudable objectives such as basing regulation on scientific evidence, engaging stakeholders in the process of developing regulation, balancing the costs and benefits of regulations and ensuring regulatory flexibility, they lack the details which would transform them from a set of nice ideas to something that has impact. This is understandable in a document of this type, but it would be good to see a move toward actionable recommendations coming out of this group.

I’m also concerned that some of the principles hint at less than innovative thinking to address the safe and sustainable development of technology innovation. For instance, while the emphasis on public participation is welcome, the principles are written in terms of modes of public consultation that rarely allow engagement with and input from citizens as opposed to mobilized interest groups. Rather than supporting the idea that posting details of public meetings and consultation periods in the Federal Register constitutes public participation, (it doesn’t), it would be good to see some innovative thinking on what true engagement means in terms of developing effective regulations for emerging technologies.

I am also unsure what “Risk assessment should be distinguished from risk management” means – especially when risk experts are beginning to explore more integrative approaches to risk assessment and management as a way of addressing complex and emerging issues.

But these concerns aside, there is a lot to applaud here. In particular, the combination of science-driven, participatory and flexible approaches to emerging technologies regulation should lay the groundwork for approaches to oversight that both protect people and the environment, and support technology innovation.

It is also worth noting that the principles align closely with the University of Michigan Risk Science Center’s vision of evidence-informed and socially-responsive action on human health risks. And they set the scene rather well for this September’s Risk Science Symposium on Risk, Uncertainty and Sustainable Innovation.

So although there is still a long way to go before technology innovation is accompanied by innovations in governance that will support rather than hinder its safe and sustainable development, these principles are an important step toward the federal government coordinating approaches to ensuring emerging technologies and emergent risks are regulated effectively.

From the memorandum:

…the following principles, consistent with Executive Order 13563 and discussed and approved by the ETIPC, should be respected to the extent permitted by law:

• Scientific Integrity: Federal regulation and oversight of emerging technologies should be based on the best available scientific evidence. Adequate information should be sought and developed, and new knowledge should be taken into account when it becomes available. To the extent feasible, purely scientific judgments should be separated from judgments of policy.
• Public Participation: To the extent feasible and subject to valid constraints (involving, for example, national security and confidential business information), relevant information should be developed with ample opportunities for stakeholder involvement and public participation. Public participation is important for promoting accountability, for improving decisions, for increasing trust, and for ensuring that officials have access to widely dispersed information.
• Communication: The Federal Government should actively communicate information to the public regarding the potential benefits and risks associated with new technologies.
• Benefits and costs: Federal regulation and oversight of emerging technologies should be based on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making.
• Flexibility: To the extent practicable, Federal regulation and oversight should provide sufficient flexibility to accommodate new evidence and learning and to take into account the evolving nature of information related to emerging technologies and their applications.
• Risk Assessment and Risk Management: Risk assessment should be distinguished from risk management. The Federal Government should strive to reach an appropriate level of consistency in risk assessment and risk management across various agencies and offices and across various technologies. Federally mandated risk management actions should be appropriate to, and commensurate with, the degree of risk identified in an assessment.
• Coordination: Federal agencies should seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues, including health and safety, economic, environmental, and ethical issues (where applicable) associated with the commercialization of an emerging technology, in an effort to craft a coherent approach. There should be a clear recognition of the statutory limitations of each Federal and state agency and an effort to defer to appropriate entities when attempting to address the breadth of issues.
• International Cooperation: The Federal Government should encourage coordinated and collaborative research across the international community. It should clearly communicate the regulatory approaches and understanding of the United States to other nations. It should promote informed choices and both sharing and development of relevant data, particularly with respect to the benefits and costs of regulation and oversight. The Federal Government should participate in the development of international standards, consistent with U.S. law and guidance (e.g., the National Technology Transfer and Advancement Act and OMB Circular A-119). When appropriate, international approaches should be coordinated as far in advance as possible, to help ensure that such approaches are consistent with these principles.
• Regulation: The Federal Government should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principles, to the extent permitted by law, when regulating emerging technologies:
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency;
  • Regulations should be developed with a firm commitment to fair notice and to public participation;
  • The benefits of regulation should justify the costs (to the extent permitted by law and recognizing the relevance of uncertainty and the limits of quantification and monetary equivalents);
  • Where possible, regulatory approaches should promote innovation while also advancing regulatory objectives, such as protection of health, the environment, and safety;
  • When no significant oversight issue based on a sufficiently distinguishing attribute of the technology or the relevant application can be identified, agencies should consider the option not to regulate;
  • Where possible, regulatory approaches should be performance-based and provide predictability and flexibility in the face of fresh evidence and evolving information; and
  • Regulatory approaches shall comply with established requirements and guidance such as the following:
    • Executive Order 13563 – Improving Regulation and Regulatory Review. Federal Register, Vol. 76, No. 14, Friday, January 21, 2011, 3821-3823, available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf;
    • Executive Order 12866 – Regulatory Planning and Review. Federal Register Vol. 58, No. 190, Monday, October 4, 1993, 51735-51744, available at http://www.whitehouse.gov/omb/inforeg/eo12866.pdf;
    • Information Quality Act (Sec. 515 of the Treasury and General Government Appropriations Act for FY 2001, Pub. L. No. 106-554); Information Quality Guidelines: OMB (2002) Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452 (Feb. 22, 2002), available at http://www.whitehouse.gov/omb/fedreg/reproducible2.pdf;
    • National Technology Transfer and Advancement Act of 1995 (“NTTAA”). Public Law 104-113, available at http://standards.gov/standards_gov/nttaa.cfm;
    • Office of Management and Budget (OMB) Circular A-119, Transmittal Memorandum, Federal Participation in the Development and Use of Voluntary Standards (02/10/1998), available at http://www.whitehouse.gov/omb/circulars/a119/a119.html;
    • OMB Final Information Quality Bulletin for Peer Review (December 16, 2004), available at http://www.whitehouse.gov/omb/memoranda/fy2005/m05-03.pdf;
    • OMB Bulletin No. 07-02 (M-07-07), Issuance of OMB’s “Final Bulletin for Agency Good Guidance Practices” (January 18,2007), available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-07.pdf;
    • OMB/OSTP Memorandum: M-07-24, Updated Principles for Risk Analysis (September 19, 2007), available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf;
    • The Trade Agreements Act of 1979, as amended (Pub.L. 96-39, 93 Stat.
      144, enacted July 26, 1979, codified at 19 U.S.C. ch.13 (19 U.S.C. §
      2501-2581);
    • A Strategy for American Innovation: Driving Towards Sustainable
      Growth and Quality Jobs” (September 2009), available at: http://www.whitehouse.gov/assets/documents/SEPT_20_Innovation_Whitepaper_FINAL.pdf; and
    • Office of Information and Regulatory Affairs, Disclosure and Information As Regulatory Tools (June 18, 2010), available at http://www.whitehouse.gov/sites/default/files/omb/assets/inforeg/disclosure_principles.pdf

I‘ve just posted a piece over on the Risk Science Blog on regulatory definitions of engineered nanomaterials.  What may come as a surprise to many readers given my comments over the years is the title – “Why we don’t need a regulatory definition for nanomaterials”!  Have I flipped, lost my senses, or what?

As you might guess, I still think that engineered nanomaterials present a huge regulatory challenge – both from the perspective of avoiding unnecessary health impacts, and providing manufacturers with clear, rational rules for their safe use.  But I also have this odd idea that regulations should at the minimum be built on evidence if the resulting rules and guidelines are to have any relevance and traction.

Sadly, it now looks like we are heading toward a situation where the definitions of nanomaterials underpinning regulations will themselves be based on policy, not science.

This scares the life out of me, because it ends up taking evidence off the table when it comes to oversight, and replacing it with assumptions and speculation on what people think is relevant, rather than what actually is – not good for safety, and certainly not good for business.

But you can read more about why I’m getting worried about a regulatory definition for nanomaterials over at the Risk Science Blog.

As anyone who has followed my work over the past few years will know, I have a deep interest in the potential benefits and risks associated with emerging technologies, and in particular whether we can swing the balance towards benefits by thinking more innovatively about risk and how we address it. So it’s not surprising that I’m extremely excited to be chairing this year’s Risk Science Symposium at the University of Michigan, which is all about how we can think differently about human health risk to support sustainable technology innovation.

The symposium is shaping up to be a unique event, and one that I hope will expose participants to new ideas as well as energizing them to explore new possibilities as they work toward developing responsible and sustainable products based on technology innovations.

Over the next few weeks, we’ll be firming up the program in time for early registration, opening on April 4.

Something I’m particularly excited about is that the symposium is turning out to be a great opportunity to explore some different formats for getting people to think differently about common challenges. Rather than use the tried and tested – but often bum-numbingly boring – “talking heads” lecture format, we will be basing most of the proceedings on a series of moderated discussions. These will be designed to engage experts from different perspectives – as well as other participants – in addressing key questions, under the guiding hand of a strong moderator.

It’s a format that one colleague described as “symposium speed-dating” – but I think it’s one that will encourage new ideas and insights, and lead to some extremely engaging exchanges. And in case you think that these will go the way of many panel discussions where participants simply use their time (and that of their fellow-speakers often) as a soap box for their own ideas, think again. We’ll be working hard to ensure that this doesn’t happen. Rather, the panels will be similar to those in the Risk Science Center Unplugged series of discussions – experts from different perspectives engaged in candid, animated yet carefully directed conversation.

And what about the the content?

Day one will lay the groundwork of why technology innovation is important, explore critical areas of technology innovation that are closely intertwined with questions over human health impacts, and begin to unpack why we need to think differently about risk and how we handle it if these technologies are to succeed.

Day two goes on to considering more closely the challenges of taking an integrative approach to addressing potential human health risks associated with technology innovation, and how new thinking on risk can increase the long-term success of technology innovation.

And in between the two days, we have what is shaping up to be a rather unique and definitely no-to-be-missed dinner event. But more on that another time.

Involved in the symposium will be leading experts from industry, government, academia, civil society, the media and other groups – all challenging and inspiring each other and the symposium participants to take a new look at how thinking differently about risk can support sustainable technology innovation.

Over the next few weeks, I’ll be posting a series of blogs on the symposium. But in the meantime, you can check out the details on the symposium website, and follow progress on the Risk Science Center Facebook page.

And remember, early registration for the symposium opens April 4 – but be forewarned, space is limited.

Cross-posted from the Risk Science Blog

Here’s an offer I’m sure you won’t be able to resist: The opportunity to read the first and last chapters of the just-published International Handbook on Regulating Nanotechnologies – for free!

Due to the farsightedness of my co-editors, the publishers have agreed to let authors post their chapters on their institutional web pages.

So if you head over to the Risk Science Blog, you can download the chapter that frames the book, and the one that pulls everything together at the end.

Don’t all rush at once!

I have to add, this was a master-stroke by Di Bowman in her negotiations with Edward Elgar Publishing- kudos to her!

Cross-posted from the Risk Science Blog.

Take a metaphorical slice through this year’s annual World Economic Forum meeting in Davos, and Global Risk would be writ large through every part of it.  Hot on the heels of the sixth Global Risk report, this year’s meeting saw the launch of the Risk Response Network – a new initiative to facilitate responsive, informed and integrative action on global risks.  And throughout the meeting, sessions and conversations abound that are grappling with understanding and mitigating emerging risks in today’s complex and interconnected world.

But important and impressive as this agenda is, I wonder whether there is something missing.

I’m approaching risk at Davos this year from three perspectives: exploring the relationship between science, innovation and risk; understanding the impact of emerging risks on public health; and developing technology-enabled approaches to risk mitigation.  The common themes here are science and technology – both as potential drivers of risk, and as sources of possible solutions.

From my work in science, technology and public health, it is clear that a deep understanding of the roles of science and technology in addressing risk is critical to building resilient and sustainable responses to global risks.  It is also increasingly clear that integrating this understanding into the process of addressing global risks is vital.

Yet this is where the World Economic Forum’s timely thrust to address global risks seems to be somewhat lacking.

Science and technology are certainly well-repented on the Davos agenda.  But I get the sense that they are part of the alternative program – “the entertainment” as one colleague described them.  This is probably a little harsh.  But the science and technology sessions do tend to be aimed at wowing delegates, rather than engaging them in exploring integrated solutions to pressing problems – a bit of light relief from the serious business of fixing the world’s problems.  Even the IdeasLab sessions, which get the closest to engaging people on emerging issues, struggle to make science and technology part of a larger conversation.

Don’t get me wrong – I’m the first to admit that there’s a lot to get excited about in contemporary science and technology.  But if robust solutions are to be found to global risks, science and technology must be integrated into mainstream discussions – not treated as an entertaining but often incomprehensible sideshow.

And that means elevating science to a seat at the table as new solutions to emerging risks are explored.

I realize that this is a daunting task. I’ll be the first to admit that scientists can be an intimidating bunch – an image they don’t necessarily try too hard to dispel.  But until scientists, engineers and technologists are seen as partners in the process of risk mitigation, not just  consultants or contractors, building resilient solutions to global challenges is going to be one tough call.

Cross posted from the Risk Science Center Blog:

There’s a lot to like in President Obama’s perspective on 21st century regulation. Writing in today’s Wall Street Journal, Obama outlines his thinking behind his new executive order to review and revise a convoluted and potentially disruptive federal regulatory system. But if regulation in the 21st century is to be effective in protecting people and enabling economic growth, it needs to become more sophisticated and innovative, while avoiding the traps of over-simplistic thinking.

I’m glad Obama puts a strong emphasis on public health in his op ed. It’s all too easy easy for these conversations to degenerate into regulatory bashing in favor of business freedom – a trap Obama deftly avoids. Yet he is spot on when he calls out the dangers of out-dated and ill-conceived regulations potentially stifling innovation and economic growth – an outcome which ultimately also impacts on public health, albeit in less directly measurable ways.

The trick is to find that sweet spot between preventing harm while supporting the economy.

As society and the technologies it relies on become ever-more complex, finding this sweet spot is becoming increasingly difficult. New technologies are spawning new products that cause harm in new and sometimes unanticipated ways. An ever more interconnected global society is eroding traditional command-and-control oversight frameworks. And a growing flood of tantalizing yet often incomplete data is creating confusion over what is safe, and what is not.

Yet the same changes that are making old-style regulation increasingly difficult are also opening up opportunities for innovation in how we protect people. Group-sourcing expertise and perspectives in new ways can help craft more responsive regulation. Novel approaches to collecting and analyzing information are able to offer new insights into balancing safe and profitable practices. New approaches to science and engineering are beginning to push risk management up the innovation chain – engineering risk out of products from the get-go. And new technologies are delivering new ways to evaluate and manage potential risks.

As well as cutting out the dead wood from the existing system, 21st century regulation also needs to innovate and take advantage of these opportunities. This will bring us closer to finding that sweet spot where both safety and economic success are achieved. But to achieve it, we will have to be increasingly sophisticated about how we think about risk and regulation.

It’s all to easy to over-react to potential risks, and to push for action based on gut instincts rather than clear evidence. This is why formal regulation starts with evidence-informed decision-making, rather than instinct and assumption. But there is also a danger of the pendulum swingging the other way, and instinctive assumptions leading to inadequate regulation.

Although the point was well-made, I must confess to being a little concerned by Obama’s comment on saccharin when he stated that “if it goes in your coffee, it is not hazardous waste”. When it comes to risk, dose and context are everything – what is good in moderation in one place can be deadly if present in excess in another. Saccharin is now widely acknowledged as safe for human consumption – hence Obama’s quip. But it won’t always be the case that what is good in small quantities is also good when dumped by the ton in the environment – especially if it has potential long-term, environmental or trans-generational impacts.

Rather than rely on over-simplistic assumptions on risk, we need now more than ever to develop sophisticated, evidence-informed yet socially, economically and politically responsive approaches to human health risks. This is at the heart of risk science, where evidence and understanding drive the process of reducing risks.

Hopefully it will also be at the heart of US regulatory reform, as we continue to strive for the sweet spot between safety and success.

- all to often, these conversations emphasize the need to prevent regulation interfering with business concerns. Obama on the other hand places human health high on the agenda. But at the same time he acknowledges the importance of good regulation in

Getting an unbiased perspective on nanotechnology is probably as close to impossible as you can get.  Governments invest in nanotech because they believe in its ability to inspire new research and stimulate economies and social change.  Corporations invest in nanotech because they think it will give them an edge in a hyper-competitive world.  Neither is likely to tell you that nanotechnology is not a good thing, without having very strong reasons to do so.  And NGO’s?  Non Government Organizations come in so many flavors that about the only generality that can be made is that they exist for a purpose – and that purpose is rarely based on an unbiased world-view.

One of the more vocal NGO’s in the nanotechnology arena has been the Canadian-based ETC Group. Formerly the Action Group on Erosion, Technology and Concentration, ETC is dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights.  To this end they often cast a critical eye on big-government and big-business-driven technology developments which – in their estimation – threaten to undermine the cultural, environmental and human rights values they adhere to.

Back in 2002, ETC called for a mandatory moratorium on the use of synthetic nanoparticles in the lab and in products, based on growing concerns over the uncertain health impacts of some nanomaterials.  The call didn’t win them many friends in government or industry, and established the group as having an aggressive social agenda as they raised questions about the emerging field.

Then in 2005, the ETC Group surveyed the political landscape of nanotechnology (through their eyes) in a special report on “nanogeopolitics”.  They concluded

“With public confidence in both private and government science at an all-time low, full societal dialogue on nano-scale technological convergence is critical. It is not for scientists to “educate” the public but for society to determine the goals and processes for the technologies they finance. There is no need for a sui generis (and inevitably voluntary) code of conduct for nanotech, but there is need for a much broader and legally-binding International Convention for the Evaluation of New Technologies (ICENT). South governments negotiating commodity and manufacturing trade-offs at the WTO Ministerial in Hong Kong in December will be asked to give away sovereignty in exchange for market access for raw materials or finished goods that may quickly become irrelevant with nanotechnology’s development.”

Now, ETC have revisited the nanogeopolitical landscape with a follow-up report: The Big Downturn?

This is clearly an assessment with an agenda – the ideology behind it is that technology development doesn’t by default enhance cultural and ecological diversity and human rights, that the actions of big-government and big-business need to be held up to close scrutiny, and that those with a vested interest in developing new technologies cannot be trusted to develop them responsibly without the support of a strong international regulatory framework.

That said, it is a well-researched report that is worth taking seriously – especially because it provides a worthy counterweight to pro-nano assessments.

Don’t get me wrong, this is not an unbiased report.  Evidence is weighed on the scales of social and environmental justice, with an eye to confirming what was already assumed.  Because of this, some pieces of information are missing, and others are given a somewhat less negative assessment than they perhaps warrant.  And there is often what I would consider a naive perspective on what nanotechnology actually is, or the effectiveness of hard regulation in ensuring safe and socially beneficial technology development.

Yet many of the evaluations in areas that I am familiar with do the source material justice, and reflect concerns that have been articulated by others.  The information presented in the report – backed up by over 400 citations – is informative, and is delivered in a style – intentionally I’m sure – not too dissimilar from a number of frequently quoted commercial nanotech analyses.  In some cases, the report doesn’t even go as far as I would have expected.  For instance, it stops short of examining the socioeconomic ramifications to developing economies of trying to keep up with the US/EU/Russia/Asia nanotech machine – perhaps more out of fear of being left behind rather than the certainty of social and economic growth.

Ultimately, this is a report that is a foil to assessments coming from pro-nanotechnology sources, which are almost always biased in the opposite direction, and in this role it is a useful resource.

If you have a vested interest in nanotechnology succeeding commercially, or are dependent on nanotechnology-related funding, or are ideologically-committed to the concept of technology-driven social development, you tend to think more carefully about writing stuff that could undermine a nanotechnology-future than you do about writing stuff that might support it. This is a bias that infuses government and industry reports.  It’s also a bias that I admit appears in the stuff that I write – I do adhere to the idea that technology-based solutions can help address pressing issues.  And that’s OK – it’s the way things work.

But it is important to recognize this bias.  And to balance it out by considering alternative perspectives.

This latest nanotech report from ETC does need to be read with open eyes.  But it does present an important counter-view that should be taken seriously as technologies such as nanotechnology are developed and deployed.

In reading it, you probably won’t agree with everything, and may occasionally find yourself having to resist the urge hit something – or someone.  But it does provide a comprehensive and important perspective on the broader social and political ramifications of the push to develop nanotechnology.

But that’s just my opinion – you might want to read it for yourself, just to check how off the mark I am!

Back in the mists of time, I was approached with a crazy proposition – would I help co-edit a book on nanotechnologies regulation!  In a moment of weakness I said yes, and a little more than two and a half years later, the book is finally about to hit the shelves.

I actually think the resulting International Handbook on Regulating Nanotechnologies rather a useful, coherent and engaging collection of chapters – my co-editors Di Bowman and Graeme Hodge did a wonderful job encouraging a bunch of top thinkers in the field to write under occasionally whimsical but always relevant titles.

To whet your appetite prior to the book’s release sometime in November, here’s a sneak peak at the contents:

PART I:    Concepts and Foundations

1.    Introduction: the regulatory challenges for nanotechnologies

Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard

2.    Philosophy of technoscience in the regime of vigilance

Alfred Nordmann

3.    Tracing and disputing the story of nanotechnology

Chris Toumey

4.    The age of regulatory governance and nanotechnologies

Roger Brownsword

PART II:    Frameworks for Regulating Nanotechnologies

5.    Nanotechnology captured

John Miles

6.    The scientific basis for regulating nanotechnologies

David Williams

7.    The current risk assessment paradigm in relation to the regulation of nanotechnologies

Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel

8.    Regulating risk: the bigger picture

Karinne Ludlow and Peter Binks

9.    Producing safety or managing risks? How regulatory paradigms affect insurability

Thomas K. Epprecht

PART III:    Case Studies in Regulating Nanotechnologies and Nano-Products

10.    The evolving nanotechnology environmental, health, and safety landscape: A business perspective

Oliver Tassinari, Jurron Bradley and Michael Holman

11.    Regulation of carbon nanotubes and other high aspect ratio nanoparticles: approaching this challenge from the perspective of asbestos

Robert J. Aitken, Sheona Peters, Alan D Jones and Vicki Stone

12.    Approaching the nanoregulation problem in chemicals legislation in the EU and US

Markus Widmer and Christoph Meili

13.    A good foundation? Regulatory oversight of nanotechnologies using cosmetics as a case study

Geert van Calster and Diana M. Bowman

14.    Therapeutic products: regulating drugs and medical devices

Rogério Sá Gaspar

15.    Regulatory perspectives on nanotechnologies in foods and food contact materials

Anna Gergely, Qasim Chaudhry and Diana M. Bowman

16.    Regulation of nanoscale materials under media-specific environmental laws

Linda Breggin and John Pendergrass

17.    Military applications: special conditions for regulation

Jürgen Altmann

18.    Regulating nanotechnology through intellectual property rights

Gregory N. Mandel

PART IV:    The Future Regulatory Landscape

19.    The role of NGOs in governing nanotechnologies: challenging the ‘benefits versus risks’ framing of nanotech innovation

Georgia Miller and Gyorgy Scrinis

20.    Voluntary measures in nanotechnology risk governance: the difficulty of holding the wolf by the ears

Christoph Meili and Markus Widmer

21.    The role of risk management frameworks and certification bodies

Thorsten Weidl, Gerhard Klein and Rolf Zöllner

22.    Risk governance in the field of nanotechnologies: core challenges of an integrative approach

Ortwin Renn and Antje Grobe

23.    International coordination and cooperation: the next agenda in nanomaterials regulation

Robert Falkner, Linda Breggin, Nico Jaspers, John Pendergrass and Read Porter

24.    Transnational regulation of nanotechnology: reality or romanticism?

Kenneth W. Abbott, Douglas J. Sylvester and Gary E. Marchant

25.    From novel materials to next generation nanotechnology: a new approach to regulating the products of nanotechnology

J. Clarence Davies

PART V:    Conclusion

26.    Conclusions: triggers, gaps, risks and trust

Andrew D. Maynard, Diana M. Bowman and Graeme A. Hodge

More information on the International Handbook on Regulating Technologies can be found here.  The anticipated publication date is late November.

A guest blog by Hilary Sutcliffe, Director of MATTER, a UK think tank which explores how new technologies can work for us all.

The other day, I wrote a piece on the implications of synthetic biology where I  suggested that we “need to place discussions on a science basis, and not get over-distracted by ethical hand-wringing.”  It was a bit of a provocative statement – intentionally so – so I was pleased to see Hilary Sutcliffe pick up on it in the comments and push back against the implication that the ethics of synbio might not be as important as some think.  Given the relevance of her comments, I thought they deserved their own guest blog – so here they are – AM.

“Ethical hand-wringing”?  Hmm, I don’t think you were quite meaning this as I have interpreted it Andrew, but I have to disagree with your point in your Synthetic Biology Blog on the ethical hand-wringing, I think we should be distracting ourselves quite a lot with Ethical Hand-Wringing while the scientists are getting on with creating their new organisms, especially considering ‘what we understand is secondary to what we can do’, as you said.

I was at the Royal Society’s Synthetic Biology Stakeholder meeting which was shown by BBC Newsnight last week, (my Mum and I spotted me fleetingly in the corner!) and this and other recent synbio events gave me many a déjà vu moment – had I accidentally gone to a nano meeting?

There are many similarities between the development of genetic modification (GM) and nanotechnologies which can be learned in the development of synthetic biology.  Time is of the essence – GM and nano were pretty much already in the shops when we started to take action, but here perhaps we can get our act together a bit sooner.

Here are quick observations on my déjà vu moments and lessons from nano and GM that may apply.  This is not an exhaustive list, just my quick on-the-hoof thoughts in response to the limited information I have:

• This is just an evolution of….. what’s all the fuss about? – ‘But it’s just an extension of GM’, ‘it’s just an extension of systems biology’, ‘it’s not actually anything really different’, ‘it’s an evolution of what we have been doing for years’.  Hello?!  Whether that is true or not from a scientific point of view, much like nano when you are close to it, that is not the point.  As the The Economist points out in its editorial this week, ‘…whatever the rational pleadings of physics and chemistry, there exists a sense that biology is different, is more than just the sum of atoms moving about and reacting with one another, is somehow infused with a divine spark, a vital essence’.  That has always been the line from nano scientists too, perhaps with even more validity. But to the lay person, or the sceptic, it looks dismissive and rather suspicious.  So though it is perhaps reasonable from a scientific point of view, I would suggest that synthetic biologists kill that ‘line of defence’, it won’t work and it never worked for nano either. Instead of calming fears, in fact it often has the opposite effect of raising further concern in the non-expert.

• ‘But first we need a definition’: Aaaahhhhh, nnnnoooooo!  Guess what, there is no definition, and I had a big déjà vu moment here – the conversation was IDENTICAL to the many I have had about nano over the years!  Standards makers, regulators, synbiologists, whoever – get this sorted. This has been a very divisive issue for nano – some say deliberately engineered – so pleeeeese address this question as soon as possible.  I may be wrong, but there doesn’t seem to be a concerted international effort on this at the moment, there needs to be, now.  An idea – call up some of the nano people and find out how they did it (as slowly and tortuously as possible) and then do it differently!

• Governance – this does seem to be considered of real importance and there is work going on worldwide on this, though it appears in academia, rather than a concerted international effort – though I may be wrong. Five Academies – sister/brother orgs to the Royal Society – are meeting soon to discuss synbio, and this will be top of the list.  Obviously we need to do much better with this than we have on nano. The Venter Institute/MIT/CSIS prepared a interesting paper on Options for Governance; in the UK, Imperial/LSE/BIOS have a Center for Synthetic Biology and Innovation group which is doing some work sponsored by the Royal Society which looks interesting; and there are other experts in universities across the world doing their own work. But the BIG lesson for me from nano, which, with the potential for serious ‘bioerrors and bioterrors’, is even more important for synbio, is to get an international effort underway, ASAP, coordinated by a group such as the UN or OECD.  I have a vision of a UN/World Economic Forum/World Social Forum joint effort.  How unlikely is that, but perhaps worth a try?  Our Responsible Nano Code was the right document, but the wrong process.  Too British (despite the fact that all our businesses on the Working Group were multinational).  A very credible international process is very important here!

• ‘The current regulation is fit for purpose, we don’t need any more’.  This may actually be the case in this instance, but the time spent arguing about definitions with nano has slowed down the potential evaluation of the need for regulation and, some argue, given us some regulation which is not really fit for purpose. Again, an authoritative, multi-stakeholder process of regulatory evaluation needs to be underway now as part of the governance development process.

• Get business and science working together from the start.  In nano there were and still are parallel discussions going on with businesses and scientists in separate silos.  We really need to do things differently for synbio.  It is at the application end where the health, safety and environment impacts and social and ethical issues really hit, and business and science need both need to understand and participate in this.  If the governance area gets done by the Science Academies alone, this is unlikely to happen.  We need to find ways of making those connections with business early and making them stick.

• Ethical Hand-Wringing and public engagement. I have been encouraged by the calls on all sides for ethical debate, public engagement and what I think of as Ethical Hand-Wringing!  The ethical dilemmas in this are quite complicated, with vested interests on all sides and we need a serious commitment from governments, scientists and businesses to communicate clearly at all stages and engage all citizens in this discussion.  However, we do need more than the usual useful and interesting sets of focus groups reaching a few hundred people.  That is not really a debate on synthetic biology, it’s market research. Obviously synbioandme.org (yes I have bagged the domain) would be a start!  But I have come to the conclusion that we need to have mass communication and mass engagement if we are to allow citizens to understand and participate in this discussion.  This is tricky and we need to be much more innovative this time round.  And I don’t see much sign of that at the moment, though it is early days.  We made some inroads with nano, (fingers crossed for Nano&me being funded!) and the Dutch are doing a very interesting mass communication/engagement job on nano (check out the Nano Podium website).  Though of course as we are all broke, it won’t be happening anytime soon!

• But what do we want it for – where’s the overarching vision? A participant at the RS meeting made a very important point, which for me is the really big question.  We in the UK do these Big Important Inquiries (e.g. the recent Bioengineering report) where the government explores the potential for a technology with experts from the field in question and lo and behold, they say it is really important and should be given lots more funding! But where is the top level independent vision and strategy which explores the UK’s approach to its big issues – energy, health, poverty, the economy, for example – and looks at which technologies could be used to solve which problems?  Synbio, nano, GM, irradiation, IT, nano/bio/info/cogno may or may not be solutions to some of our most pressing problems, but unless applied research funding, economic incentives and commercial R&D is looked at in the context of other solutions, including non-technical ones, we can’t really be confident that we have got the right solutions to the right problems.   In addition, this is the very best time and place to anchor the Ethical Hand-Wringing, it would make public debate mean something, influential and galvanise everyone – from scientists to businesses, NGOs to governments – to engage better about the benefits of their work and debate real issues which will be relevant now and in the future.

Other countries do it – this must be an important priority for the new UK government. We have time with synthetic biology to get this right, we just need to get going now.

This piece also appears on the MATTER blog

A bit of a wonky blog I’m afraid, but having seen relatively little on the recently introduced Safe Chemicals Act of 2010 and its relevance to engineered nanomaterials on the web, I thought I would post something short and sweet here.

Just over a week ago, Senator Lautenberg introduced a bill in the US Senate aimed at a long-overdue reform of toxic substances regulation in the United States – the Safe Chemicals Act of 2010.  At the same time, Congressmen Rush and Waxman released a discussion draft in the House – The Toxic Chemicals Safety Act of 2010 – covering much of the same ground.  Both documents aim to update substantially the Toxic Substances Control Act, or TSCA – which has been the mainstay of US chemicals regulation since 1976.

Both the 169-page Safe Chemicals Act of 2010 and the slightly shorter 119 page long Toxic Chemicals Safety Act of 2010 aim to bring US chemicals safety regulation into the 21st century.  Richard Denison at EDF has already posted a comprehensive overview of proposed changes to the regulation that I would recommend reading if you are into this stuff.  But here, I thought I would highlight what the proposed changes mean for the engineered nanomaterials – a class of substances that have been a bit of a thorn in TSCA’s side for the past few years.

The problem with TSCA (the old version) is that it is built on a chemicals world-view – substances are regulated based on their unique “molecular identity” – how they are described as chemicals. This works well for substances that do what they do because of their chemistry.  But it runs into problems where something behaves in a certain way because of its physical form, as well as its chemical makeup.  In other words, where you have stuff that is more harmful that molecular identity would suggest because of how the constituent atoms and molecules are put together, you have a problem.

There are workarounds to this within TSCA – a new substance that is chemically identical to an existing one can be regulated under the “Significant New Use Rule” for instance – but it’s a bit of a bootstrap.  And with the emergence of an increasing number of engineered nanomaterials where functionality – and possibly toxicity – depend on physical form as well as molecular identity, this bootstrap has been stretched to breaking point.

So there’s been considerable interest in how the new-look TSCA will handle this.

Fortunately, things are looking good at this stage.  The Senate bill has language that is in effect a substance “get out of jail free” card for EPA.  Section 4 of the bill proposes amending section 3(2) of the original Toxic Substances Control Act with

“Notwithstanding molecular identity, the Administrator may determine, under section 5(a)(6), that a variant of a chemical substance is a new chemical substance.” (page 6)

In other words, EPA can decide when something with the same molecular identity as an existing substance should be treated as a new substance.

And the determiners of when this is justified? The bill proposes that section 3(13) of the 1976 TSCA act is amended with

“(C) SPECIAL SUBSTANCE CHARACTERISTICS.—The term ‘special substance characteristics’ means, such physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider—

(A) size or size distribution;

(B) shape and surface structure;

(C) reactivity; and

(D) any other properties that may significantly affect the risks posed.” (page 13)

In other words, the new bill allows many of the characteristics that potentially lead to engineered nanomaterials presenting novel risks to trigger them being treated as new substances.

The House draft document is a little more explicit.  It recommend amending section 3(2) of the original act with:

“(C) For purposes of this Act, such term may include more than 1 form of a substance with a particular molecular identity as described in sub-paragraph (A) if the Administrator has determined such forms to be different substances, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances.” (page 6)

with the clarification that

“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—

(A) chemical structure and composition

(B) size or size distribution

(C) shape

(D) surface structure

(E) reactivity; and

(F) other characteristics and properties that may bear on toxicological properties” (page 11)

Both the Senate bill and the House discussion document provide EPA with the authority to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance.  This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance.  But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented.  In other words, these provisions effectively future-proof the new regulation.

Of course there’s a long way to go yet.  The final details of the new legislation have to be hashed out between the Senate and the House before they are finally signed off on.  Then the process of interpreting and enacting the new regs starts – including working out how exactly to determine when something should be considered new for regulatory purposes.

But at least things seem on the right track as far as enabling the safe development and use of engineered nanomaterials goes.

_____________________________

The two documents can been downloaded here:

The Safe Chemicals Act of 2010 (US Senate)

The Toxic Chemicals Safety Act of 2010 (US House of Representatives)

There’s a bit of a brouhaha over nanotechnology safety brewing over at AOL Online.  A few weeks ago, investigative reporter Andrew Schneider posted a series of articles questioning both the safety of nanotechnology-enabled products entering the market, and the US government’s response to the emerging challenge.  Today, Clayton Teague – Director of the US National Nanotechnology Coordination Office – hit back with an opinion piece calling Schneider to task…

I mention this because earlier today, Andrew Schneider posted a new article in his nanotechnology series that examined a recent report from the President’s Council of Advisors on Science and Technology – a report which Teague describes in his op-ed as “Perhaps the best and most impartial review of the nation’s efforts in the realm of nanotechnology safety and oversight.” In this new piece, Schneider quotes me on yet another document that is germane to this debate.

Confused yet?  Let me try and explain.

When Schneider’s original series – “The Nanotech Gamble: Bold Science.  Big Money. Growing Risks” – came out, the feds were understandably upset; they didn’t fare too well in the assessment, and felt that they – not to mention the science – were a little hard done by.  So they set to work on developing a strategy to counter the pieces.

As it happens, the US National Nanotechnology Initiative was due to hold a public workshop on nanotechnology risk and ethical issues a few days after the AOL series was published.  At this meeting were a number of invited speakers and guests from academia, business and elsewhere – a perfect venue for public questions about nanotechnology-related risks, but also a potential opportunity to put some misunderstandings and misconceptions to bed.

I’m not privy to the events between the publication of the AOL pieces and the so-called Capstone meeting, but I do know that they resulted in some (not all) of the invited speakers and guests being issued with “response points” – just in case they were asked some tricky questions.

These response points were circulated widely, and as a result copies of them landed in my email box – this wasn’t a restricted document.  I mention this because Andrew Schneider’s latest piece not only refers to them, but also quotes my response to reading them (I’m not going to cite myself – you can read what I had to say here).

However, as their existence is now out in the open, I thought it only fair that I let others see what Schneider was referring to:

AOL Story about Nanotech – Some Response Points

• AOL Web site is running a three-day series on nanotechnology by a reporter who has spent months reporting the story, including interviews with many agency scientists.
• Takes an alarmist perspective: Despite the lack of evidence that anyone has ever been harmed by an engineered nano product, it presumes that nanotechnology (wrongly construed to be a singular entity) is inherently dangerous until proven safe, ignoring reality that nanotech encompasses an enormous range of materials and products whose risk—if any—depends on where and how they are made and used.
• Uses irrelevant examples, for example: Cites a study finding DNA damage in mice fed nano-TiO2 (used in paint and sunscreens), but no studies have shown a convincing link between this widely used chemical and human illness and the story does not mention (but we have checked and learned) that exposures in the study were more than 10 times those allowed in food by FDA regs.
• Claims that “most federal agencies “are doing little to nothing to ensure public safety” and are “ignoring warning signs.” Truth is the U.S. is the global leader in research into nanotech’s potential environmental, health, and safety (EHS) risks.
  • Between FY 2005 and FY 2009 the National Nanotechnology Initiative (NNI) will have invested $254 million in research whose primary function is to understand EHS issues—more than all other countries in the world combined. And that does not count the large amounts of research that contribute to health and safety knowledge indirectly, such as basic research on how to measure the stuff in the first place.
  • Federal research dedicated to nano-related EHS research has grown substantially from $34.8 million in FY 2005 to $74.5 million in FY 2009 and an estimated $91.6 million for FY 2010. The FY 2011 request is a record $116.9 million.
• Risk must be balanced against benefits, and the essentially theoretical risk that has so far been identified should be balanced against the benefits in terms of sophisticated products and economic growth and jobs created by this expanding industry.
• Just yesterday (Thurs) PCAST released its report on the National Nanotechnology Initiative—the the 10-year-old, multiagency initiative that has supported this fledgling science of the extremely small to the tune of about $12 billion over the past decade—finding that the U.S. is the global leader in nanotech by any number of measures (including patent filings, scientific journal citations, and investments in R&D).  This is a young and promising industry we can still own as a Nation, so we should not let fear overtake common sense, even as safety studies and regulatory updates continue.

(Circulated by the federal government to some external guests and speakers at the March 30-31 NNI Capstone meeting on March 26)

Great fodder for a case study on how a government initiative investing in a new technology responds to public criticism, don’t you think?

According to the American Association for the Advancement of Science (AAAS), the White House Office of Science and Technology Policy (OSTP) plans to form a new interagency group on emerging technologies, including nanotechnology and synthetic biology.  The announcement was make by Tom Kalil, deputy director for policy at OSTP, at a government-organized workshop on Risk Management Methods and Ethical, Legal, and Societal Implications of Nanotechnology held last week.  The AAAS policy alert (not available on the web yet available here) noted that the group is intended to provide research funding agencies and regulatory agencies an opportunity to discuss emerging policy issues.

Unfortunately I wasn’t at the workshop in Washington DC where Kalil made his remarks, and so don’t know any more about this than was included in the brief note from AAAS.  However, from what was reported, this seems a sensible move – if carried through thoughtfully.

Nanotechnology – arguably the US government’s flagship emerging technology – has highlighted the need for smart policy decisions when developing new technologies.  What started as a science-based initiative to promote new research, stimulate innovation and create new jobs, has increasingly become entangled in the social, political and economic impacts of science and technology promotion.  Ten years after President Clinton established the National Nanotechnology Initiative (NNI) – the initiative that coordinates nanotechnology activities across federal agencies – there remains an uneasy relationship between the desire to drive science discovery and technology innovation, and the need to understand and manage the potential safety, societal and economic impacts of this push.

At the heart of this uneasy relationship is a built-in resistance to asking “un-askable” questions.

The NNI’s vision is “a future in which the ability to understand and control matter at the nanoscale leads to a revolution in technology and industry that benefits society.” The vision is built on a belief that increasing our ability to control matter at the nanoscale is essential, that this will lead to a technology revolution, and that this revolution will benefit society. This is a powerful driver, and has contributed largely to the success of the NNI specifically and nanotechnology more broadly.  But it does mean that people who ask difficult questions tend to be tarred by a brush that’s reserved for whistle blowers and inconvenient activists.

This has been seen in the slow and sometimes reluctant inclusion of research into potential health and environmental impacts under the NNI umbrella; a resistance to developing government-wide policies on developing nanotechnology responsibly (a resistance usually justified by the NNI being a science initiative, not a policy initiative); and negligible efforts to include citizens who stand to gain or loose from nanotechnology as partners in the process (see David Guston’s piece on this for instance).  There has also been a surprising lack of analysis of the broader economic impacts of nanotechnology promotion – as opposed to the economic benefits.  How many companies and economies have invested in nanotechnology simply because the US set an aggressive lead – and what has been the economic impact of this “follow the leader” mentality?

The reality is that in any initiative dedicated to promoting a given technology, people and organizations that raise issues and recommend actions that threaten to undermine this promotion risk being marginalized.  And this ends up playing into personal and agency self-interest – why give up a position of influence and the promise of funding for the sake of asking difficult questions? I can only imagine what the response to a NNI member who suggested the usefulness of the initiative should be re-examined would be – I suspect it would not be pretty!  Yet if sound and strategic policies are to be developed that benefit citizens, the “un-askable” questions are often the most important ones.

Looking forward, there is a need to develop emerging technology-related policies that are balanced by considerations other than technology promotion. alone  But on top of this, there is a need to develop more holistic approaches to emerging technologies in general.  Nanotechnology is not the only new technology on the block – technologies emerging under the banners of synthetic biology,  robotics, geoengineering, cognitive enhancement and a plethora of others are coming up fast.  Then there are the gray areas between these where convergence leads to increasingly complex and ill-defined technologies.  In the face of accelerating innovation, should policies be developed for each and every new technology that comes along?  This would be exceedingly difficult to achieve now, and an impossible task I suspect a few years down the line.

One solution – and the one the White House seems to be pursuing – is to take a high-level approach to emerging technology policy that ensures cross-agency coordination, identifies emerging hot-spots and enables a balanced and socially-responsible approach to emerging opportunities and issues.  In some ways this is a role that the long-defunct Office of Technology Assessment within the US Congress played.  But looking to an increasingly technologically-complex future, I suspect that a complete rethink of how to ensure the benefits of new technologies are realized and the dangers avoided is needed.

Depending on how it develops, the new White House interagency group could well lead to coordinated action on emerging technologies that ensures policies are responsive to the needs of citizens – not just those who have a vested interest in technology promotion.  But I can guarantee it will hit resistance from agencies, organizations and individuals who stand to loose out from this move – including those who stand to loose funding or influence as a result. of it  Yet if the US government is to embrace technology development that benefits society as a whole – especially in light of President Obama’s Innovation Strategy – it surely must create a policy forum where the “un-askable” questions can be asked; where no one interest group within the government can dominate proceedings; and where hurdles to social and economic prosperity can be identified, assessed and addressed without fear of agencies and individuals being marginalized.

Done right, this could be a critical step toward the US developing a 21st century approach to 21st century technologies.

_______________________________________

In order to ensure the new group’s effectiveness, OSTP are going to have to grapple with some tough issues.  These will include, amongst others:

Links to technology-specific initiatives. I would imagine that the new group will function best as  a complementary activity to initiatives such as the NNI.  There is clearly benefit to having strong technology-promotion initiatives like the NNI, and it would seem foolish to diminish these.  And initiatives like this are essential for intelligence on where emerging technologies are going.  Yet at the same time it is important that policy decisions are decoupled somewhat from technology promotion.  One way to do this is to ensure strong links between initiatives such as the NNI and the new group.

Agency-engagement at a senior level. To avoid yet another talking-shop, the new group will need to engage agencies at a senior level – ensuring that participants have decision-making authority.

Balance of interest. To the extent that it is possible across federal agencies, the group is more likely to be effective if there is balance between different interests – including science, business, economic growth, social development and prosperity, and oversight.

Funding. One fear of establishing a group like this is that it will undermine efforts to fund oversight and social impacts-related research through initiatives such as the NNI.  This is a serious concern, although it would be dangerous to place research funding interests within specific sectors ahead of sound policy formulation.  Nevertheless, it would be prudent to both ensure the new group does not adversely impact on current funding into the challenges and potential impacts of emerging technologies, and to develop mechanisms to support and stimulate new funding to address strategically important issues.

Stakeholder input. It is hard to imagine how the planned interagency group will function effectively without non-government stakeholder input.  In the absence of balanced input from different stakeholder groups – representatives of business, citizens and academia in particular – cross-government policies on emerging technologies are unlikely to be relevant, responsive or effective.  This will almost definitely mean setting up a Federal Advisory Committee to the group  to ensure informed and representative input.

Back in February of 2009, the UK House of Lords Science and Technology Committee launched an inquiry into the use of nanotechnology in food products and the food industry.  Chaired by Lord Krebs (the son of Hans Adolf Krebs – best known for describing the mechanisms of energy uptake and release in cells), a small group of peers was assembled to address the potential benefits and use of nanotechnology in the food sector, arising health and safety issues, regulation, communication and public engagement.  On January 8 2010, the subcommittee’s much-anticipated report was published.  Concluding with 32 recommendations covering nanotechnology and food commercialization, potential risks, regulation and public communication and engagement, it is perhaps the most comprehensive and authoritative report on the subject to be published to date.

The UK House of Lords has, on occasion, been depicted as an anachronistic institution full of political has-beens who enjoy nothing more than a quiet snooze, lulled to sleep by the interminable droning of their peers.  Of course, reforms brought in over the past decade have done a lot to shatter this illusion.  But if there are any lingering doubts, this report should dispel them.   Under the expert guidance of Lord Krebs, this group of sharp minded and well-informed members of the House of Lords has provided an insightful and balanced perspective on the opportunities and challenges of using nanotechnology (or “nanotechnologies” as they more appropriately refer to them) in the food industry.

The process was helped enormously by an extensive consultation process.  Fifty written submissions from a wide range of stakeholders, a number of oral testimonies and meetings with experts and stakeholders in Washington DC all helped to support the committee in its assessment.  The final document reflects the input of these stakeholders, frequently citing input from industry, academics, government agencies and Non-Government Organizations.  Yet despite the breadth of information submitted, there is a strong sense that these inputs were carefully weighed and evaluated by the committee before they drew their conclusions and recommendations.

The report is clearly written and accessible, and I would recommend strongly anyone working with nanotechnology and food to read it in its entirety.  I suspect that it is going to become a significant and influential factor in the development of responsible and acceptable uses of nanotechnology in food products.

For those with less time and interest, I would recommend reading the summary at least, which captures the essence of the report in a couple of pages.

Just to whet your appetite though, here’s my initial impression of the report and its recommendations in four areas – Nanotechnology and food, knowledge gaps, regulation, and communication & outreach.

Nanotechnology and Food

The report shows a remarkable level of sophistication in its evaluation of nanotechnology and food.  It recognizes the long history of using technologies to modify food, recognizes consumer caution over the scientific manipulation of food products, and acknowledges the complexities surrounding the introduction of potentially beneficial new technologies.  It also highlights the rather indistinct lines between nanoscale materials that have been present in foods forever (such as protein nanoparticles in ricotta cheese) compared to those more recently and intentionally introduced, and new materials that behave in unusual ways compared to those that are just small.  This clarity of perception underpins many of the report’s recommendations.

The potential of nanomaterials to add value to food products is readily acknowledged in the report:

“Nanomaterials have a range of potential applications in the food sector that may offer benefits to both consumers and industry.  These include creating foods with unaltered taste but lower fat, salt or sugar levels, or improved packaging that keeps food fresher for longer or tells consumers if the food inside is spoiled.”

But the authors go on to note that the number of nanotechnology-based food products on the market is currently small.  To help ensure the responsible development of nanotechnologies in the food sector, recommendations are made on government actions to “ensure the potential benefits to consumers and society are supported,”  including improving the effectiveness of technology transfer between researchers and industry.

Counterbalancing the technological promise of nanotechnology, the report’s authors are also highly aware of the broader social issues surrounding the use of emerging technologies in food.  And as a result, the majority of the report’s recommendations are focused on addressing and responding to these issues.

Knowledge gaps

Despite the promise of nanotechnology in the food sector, the report highlights a number of critical knowledge gaps to developing safe and trusted nanotech-enabled food products.  Again, the discussion is informed and comprehensive.

At the outset, the report notes that the subcommittee “received no evidence, however, of instances where ingested nanomaterials have harmed human health,” dispelling fears of speculative scaremongering (although I see that early press coverage is focusing on risks and uncertainties). At the same time the report’s authors acknowledge that the

“novel properties of engineered nanomaterials may affect how such materials interact with the body and the risks they present to human health.”

Six areas of concern are flagged where novel nanomaterials might cause unexpected harm, covering the influence of particle size, solubility & persistence, chemical & catalytic reactivity, material shape, anti-microbial effects and agglomeration & aggregation.  Despite these concerns – which have been raised repeatedly by researchers and others over the past few years – the report notes a dearth of research on the “impact, behaviour and interactions of nanomaterials in the [gastrointestinal] tract, including their effect on gut flora.”

Targeted research to fill this knowledge gap is a key recommendation of the report.

Regulation

The report’s authors devote a large chunk of space to the issue of regulation – addressing regulatory coverage and regulatory enforcement.  Although somewhat dry for a lay reader, these sections of the report tackle directly a number of issues that have plagued discussions of nanomaterial regulation for some time, including definitions, working with mixtures and labeling.

The report’s authors are very clear that a regulatory definition of nanomaterials is essential.  But they are also clear that any definition should be based on functionality rather than size – throwing out the idea that there is anything special about the traditional 100 nm cut point for nanomaterials.

The argument is made that, from a regulatory perspective, what is important is when a material starts to behave differently from what is expected – when the way that it interacts with the body is no longer the same as what is observed with a larger lump of material with the same chemistry.  This may happen at very small particle diameters with some materials – just tens of nanomaters.  But it may also occur at relatively large particle diameters for other materials.  As a result, the report recommends that regulatory definitions of nanomaterials

“should not include a size limit of 100 nm but instead refer to the ‘nanoscale’ to ensure that all materials with a dimension under 1000 nm are considered.”

This placement of the upper limit of the nanoscale at 1000 nm may well be the most controversial aspect of the report.  But the emphasis on functionality is a welcome one – as long as we can define what functionality means!

In the report’s recommendations it is also very clear that, for regulatory purposes, any definition of ‘nanomaterials’ should exclude those created from natural substances, “except for nanomaterials that have been deliberately chosen or engineered to take advantage of their nanoscale properties.”

The report also touches on the contentious issue of mixtures – powders that contain some fraction of particles which are nanometer-sized.  What do you do if you use a powder in a food product that also contains a small number of nanometer-scale particles (as most powders invariably will)?  There isn’t much insight into how to resolve this issue in the report (or elsewhere for that matter), but the report’s authors do recommend that the UK Government develops guidelines that clearly state what fraction of a powder needs to be at the nanoscale before nano-specific regulatory oversight is triggered.  This is critical to the effective regulation of nanomaterials in food products if products are not to be inappropriately under- or over-regulated.  (Imagine a scenario where a manufacturer could claim exemption from nano regs because a small fraction of a material was larger than the nanoscale, or a regulator over-zealously  applied regulations by insisting that a conventional material containing a small fraction of nanoparticles was a nanomaterial. The only thing worse would be a complete lack of clarity on when a product containing a range of particle sizes was considered nano and when it was not – which unfortunately is where we are at the moment!)

On labeling, the report states

“Consumers can expect to have access to information about the food they eat.  But blanket labeling of nanomaterials on packages is not, in our view, the right approach to providing information about the application of nanotechnologies.”

Rather, the report’s authors recommend a public registry of foods containing nanomaterials.

Communication & Outreach

Six of the report’s recommendations deal directly with effective communication and public engagement.  From the outset, the report’s authors recognize the importance of public attitudes towards food, and the need to engage consumers in the use of nanotechnologies in food products.  The report’s summary opens

“People are understandably sensitive about changes to the food they eat.  In the past the introduction of novel technologies in the food sector has sometimes met with resistance or even holstility.  The public’s attitude toward food is influenced by a number of considerations including a fear of novel risks, the level of trust in the effectiveness of regulation, and other wider social and psychological factors (shaped by views on health, the environment and science).  The development of nanotechnologies in the food sector may well elicit some of these concerns.”

Later on, the report states that “our witnesses confirmed that public attitudes towards the use of nanotechnologies were among the most important factors in determining their future in the food sector.”

Transparency within the industry was seen as critical to addressing potential public fears and concerns.  Yet after talking with stakeholders, the subcommittee came to the conclusion that the food industry are being far from transparent at the moment, and that this may potentially damage the responsible use of nanotechnologies in foods in the long run.  They “found it regrettable that evidence indicated that, far from being transparent about its activities, the food industry was refusing to talk about work in this area.”

A number of witnesses stressed the reticence of food companies to talk about nanotechnology openly, for fear of a loss of consumer confidence.  Franz Kampers from Wageningen University told the subcommittee

“the industry is very, very reluctant to communicate that they are using nanotechnology in food … because they are very much afraid oof the reaction of consumers to the product.”

Yet after hearing evidence from a number of quarters, the subcommittee concluded that

“this is exactly the type of behaviour which may bring about the public reaction which it is trying to avert.”

As a result the subcommittee recommended that the UK Government work with the industry to ensure greater openness and transparency about what they are developing, and what their plans are for using nanotechnology in food products.

The subcommittee also stressed the need for a robust Government communication strategy.  They praised the Government for establishing the Nano & Me website, which provides anyone who is interested with accessible information on nanotechnology – including its use in food.  Unfortunately, they failed to note that Nano & Me is under threat because the UK government isn’t stumping up paltry sums of money to ensure its upkeep!

Finally, the report emphasizes the need for public engagement, which provides people with the opportunity to participate in decision-making processes.  They acknowledge that this is a complex task, and have some interesting perspectives on how to proceed here.  In particular, the suggest that the provision of engagement opportunities might in itself be sufficient – that people will be reassured that someone has the opportunity to engaging on their behalf – and that the voice of the public”is often most effectively mediated by representative groups such as consumer groups, non governmental organisations (NGO’s) and individuals with a particular interest in this topic.”

I’m not sure how far I agree with these suggestions.  But perhaps the most important thing here is that the subcommittee recognize that engagement is about giving people a voice and a place at the table, not just about communication.

These are just some of the things that jumped out at me as I read through this report today.  There are many other aspects to it which deserve greater attention.  Not all of the comments and recommendations will meet with universal approval I am sure.  But without a doubt, this is the most thoughtful, informed and insightful piece on nanotechnology and food I have read in a long time.

The full House of Lords Nanotechnologies and Food report is available here.

By Jim Thomas, ETC Group

A guest blog in the Alternative Perspectives on Technology Innovation series

For a fresh perspective on how to do technology governance consider starting somewhere else. I suggest York Castle in Northern England – a stark stone tower from the thirteenth century.

It was here in 1812 that the English state first executed fifteen men for the newly established crime of machine-breaking. They were Luddites – the original kind: artisan weavers who saw the factory system as an assault on their livelihoods and communities. At the time England was convulsed by the ‘machine question’ – with fiery debates in parliament and hundreds of fiery attacks on cloth mills by followers of the mythical Ned Ludd. As the first industrial revolution gathered steam, literally, the political class made a deliberate decision to side with the new industrialists. 12,000 Soldiers were deployed to quell the Luddite uprising – more than were abroad fighting Napoleon. The Frame Breaking Act made Luddism punishable by death and in time the word Luddite itself was transformed into a term of contempt and abuse that lasted all the way to 21^st century science debates. Its fair to say the Luddites lost – big time.

I should admit right now that I’m a big fan of the Luddites – Not that its much fun supporting an extinct political movement. Unlike sports teams there’s neither merchandise to buy nor Facebook groups to join (not unless you count this: http://www.facebook.com/pages/Ye-Luddites/121981285761?v=info ). But I like Ned Ludd and his gang for two reasons.

Firstly I think they were right in ways they didn’t even know at the time. Our contemporary crises of climate change, overproduction and industrial pollution trace back in obvious ways to the industrial revolution as do the emergence of  urban and labour problems that flowed from the factory system and the urbanization that it gave rise to. The new cloth factories made possible a level of demand that justified establishing cotton plantations and a vicious slave trade setting in motion cycles of violence and racism that still persist today. Did the industrial revolution also bring benefits to society – of course it did although those benefits remain very unevenly distributed. Did the Luddites know they were fighting the roots of future racism. No – but their instincts were good.

Secondly I admire the Luddites for their success (albeit brief) in creating  a large-scale truly popular debate about emerging technologies. The widespread uprising of 1811-16 was more than just a wave of hysterics. Popular geek culture casts a ‘Luddite’ as a technologically inept dunce, fearful of change. Historical accounts reveal nothing of the sort. Real Luddites were adept users of complex hand weaving looms. They often espoused nuanced views on the technological revolution happening around them. They were not uniformly anti-technology: Their grievances, as recorded in song and declarations , were specifically with technologies that were “harmful to the common good” – as good a standard as any against which to asses technological appropriateness.  In their night time raids they would break some mechanical frames that they considered unjust while leaving others untouched that they considered benign. They recognised technological power as political, entwined with monopoly power and responsible for a lowering of standards and production of shoddy goods. They even practiced a radical form of democratic  technology assessment that we haven’t seen the like of since: dragging bulky mechanical looms to the market place to hold public trials in which all the community could pass judgement on the new machines – a public consultation process of the most inclusive kind.

I was once involved in organizing such a Luddite-style technology trial – at York Castle no less. A group of fellow activists dragged a motor car to the old stone tower and we set up public court, inviting bystanders to testify for or against the impact of the internal combustion engine on all our lives. Road kill, asthma, community destruction and climate change were weighed against the increased mobility and economic opportunities provided by four fast wheels. Everyone who happened to pass by became the jury.  On balance the car was found guilty of being ‘harmful to the common good’ but received a lighter sentence than the Luddites had on the same spot. This symbolic exercise in popular assessment of technology was exactly 100 years too late to influence the relevant innovation policy. Nonetheless it set me thinking: What if we weren’t too late? What if we could drag emerging technologies into a modern court of public deliberation and democratic oversight. What might that look like?

I’ve been turning over that question for about 15 years now while active in global debates on emerging technologies –  particularly GM Crops, Nanotechnology, Synthetic Biology and  Geo-engineering – Debates in which I’ve encountered the term Luddite, meant as a slur, more times than I care to count. Language like this tumbles carelessly out of history .. but I find the parallels striking. Once again we are in the early phases of a new industrial revolution. Once again powerful technologies (Converging Technologies ) are physically remaking and sometimes disintegrating our societies. Those  of us in civil society carrying out bit-part campaigns, issuing press releases and launching legal challenges are in a sense attempting to drag technology governance away from the darkness of narrow expert committees and into the sunny court of public deliberation for a broader hearing.. It seems a perfectly reasonable and democratic urge. But there’s got to be a better and more systematic way to do that?

So far I’ve found three sets of proposals that might begin to put technology oversight into the open and back in the hands of a wider public:

• Public Engagement: Citizens Juries, Knowledge exchanges, People’s Commissions.

No don’t yawn. I grant you that science policy types (and the rest of us) have every reason to groan when they hear the term “Public engagement in Science”. Like other  empty buzz phrases (“sustainable development” and “corporate social responsibility” come to mind) its too easily appropriated – but there is still (just about) some value in imagining and practicing what actual involvement mechanisms we could craft to enable a more democratic form of innovation governance.  Citizen’s Juries in places as diverse as Andra Pradesh, Mali and Brazil have enabled marginalized groups such as farmers to at least take a place alongside seed companies and biotech giants in policy processes. While People’s Commissions (investigation processes run by citizens groups) may get short shrift from a condescending political establishment yet can often exhibit excellent foresight, drawing on sources of grassroots knowledge  that closetted self-referential science committees might never open up to. These days my faith in public engagement  is waning having watched several governments employ such processes as a thinly disguised public relations ploy or to tie up the energies of civil society. Unless a public engagement process has a clear promise by those in power that they will listen, respond and demonstrably act on reccomendations its likely to lose the interest of the participants too.

• Global Oversight: ICENT.

ICENT stands for the International Convention for the Evaluation of New Technologies – a UN level body for foresighting emerging technology trends and then applying a wide-ranging assessment process that will consider the social, environmental and justice implications of the innovation being scrutinised. It doesn’t exist yet and maybe it never will but at ETC Group we have dedicated a lot of time to imagining what such a body could look like (we even have some nifty organagrams – see pg 36-40 of this) For example there would be bodies scanning the technological horizon and others making a rough reckoning of whether a new technology needed a strong oversight framework or not. Others tasked with bringing in a broad range of knowledge (what do the indigenous folks say?) or identifying exactly the right place in the system of global governance to begin regulatory moves. At a time when tech governance is several decades late each time we find a new platform emerging (Nanotech? Synthetic Biology? Geoengineering?) An ICENT–like body could maybe get international machinery in gear a bit quicker – ideally before industrial interests have already written those technologies into next quarter’s earning sheets and are shipping them to market.

• Popular assessment : Technopedia?

The only governance and regulations that work are those where somebody is paying attention – so  rather than hide technology assessment in rarefied committees why not hand it to the wisdom of the crowds. Wikipedia may not be the most perfectly accurate source of all knowledge but it is comprehensive, up to date and flexible and provides an interesting model. Actually Wikipedia entries are often not a bad place to start if you want to suss out the societal and environmental issues raised by the zeitgeist regarding new technologies. How about a dedicated wiki site for collaborative monitoring and judging of emerging technologies? Such a site could be structured so that, unlike the halls of power, marginal voices have a space and are welcome. A grassroots army of  volunteer technology assessors could help fill out the questions that Brussels or Washington never asks: What is the feminist take on this technology? How does it impact indigenous or disabled groups? What livelihood issues does this raise for the poor? Will the global commodities trade be affected? Perhaps an extended social media approach to technology assessment could convene online juries, host global conference calls and draft peoples reports for input into policy deliberations.

Don’t get me wrong.. approaches like these are not panaceas .. Adopt them all and some of us in civil society  might still feel there are a few metaphorical mechanical frames that would still need breaking. For example I’m not sure a modern day Ned Ludd would be content to spend his whole time writing wiki entries.

Then again, at least he might participate in his own facebook group…

______________________________

Jim Thomas is a Research Programme Manager and Writer with the ETC Group based in Montreal, Canada. His background is in communications, writing on emerging technologies and international campaigning.

Formerly an organiser with grassroots direct action movements in Europe and North America, Jim spent seven years with  Greenpeace International as a campaigner on food and genetic  engineering issues before joining ETC Group in 2002. Jim organised the  first international meeting on the societal impacts of Nanotechnology (held in the European Parliament), speaks around the world on  emerging technology issues and has authored several reports, chapters and press  articles on Biotechnology, Nanotechnology, Synthetic Biology and  GeoEngineering.  He writes a regular ‘Tech Reckoning’ column for The Ecologist Magazine exploring the  politics of next generation technologies.

Trained as a historian to look back at the history of technology, Jim is now proccupied with the future of technology. Once upon a time he was an award winning slam poet but then he had children…

ETC Group have a blog too…

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.

I’m often intrigued by the evolution of an article from its early drafts to the final version.  To complement today’s commentary on nanotechnology regulation in the journal Nature, written jointly with David Rejeski, I thought it would be interesting to post an early draft of the same paper here.  This is what the piece looked like before we started working with the journal’s editors on cleaning it up and squeezing it into an impossibly small number of words (apart from a couple of very small edits to make sure it was up to date and relatively error-free)…

As nanotechnology makes the leap from the lab to the marketplace, regulators are faced with the tough challenge of ensuring safety without stifling innovation.  Get it right and everyone stands to benefit from the economic and technological returns that engineering matter at the nanometer scale promises.  But get it wrong, and people, the environment and business all loose out.  However, developing approaches to effective regulation depends on good science and reliable information—delivered at the right point and at the right time.  In 2006, the UK government initiated a voluntary reporting scheme to collect data from industry on the commercial production, use and handling of engineered nanomaterials as a step towards evidence-based oversight.  Followed shortly after by a similar scheme in the US, both have failed to live up to expectations.  Canada and France are now working on instituting mandatory reporting programs to collect similar information.  This is a welcome move towards the effective oversight of nanotechnology-based products.  But it is only one of many steps that are needed if the promise of this emerging technology is to be realized.

Me handling multi-walled carbon nanotubes some years ago. Data are still needed on how to get the most out of this innovative material while using it safely.

Nearly five years ago, the UK Royal Society and Royal Academy of Engineering stressed the need for evidence-driven oversight of engineered nanomaterials.(RS/RAE 2004)  Since then, the global investment in nanotechnology R&D by the public and private sectors has risen to over $18 billion annually (Lux Research 2009) and nanotechnology has passed from a scientific curiosity to a market reality, with hundreds of substances and products in commerce. Yet discussions continue to revolve around the safety of the technology rather than the many and varied products it leads to… In 2006, five research challenges were proposed that, if addressed, would help underpin evidence-based decisions on using the products of nanotechnology safely (Maynard, Aitken et al. 2006).  Movement has been made towards addressing all five of challenges, which covered exposure monitoring, toxicity testing, predicting and avoiding harmful behavior, evaluating material impact from cradle to grave, and establishing strategic research programs for addressing possible risks.  Yet developers and regulators are still a long way from understanding how to predict and manage the potential risks associated with new nanomaterials (National Academies 2009; SCENIHR 2009).

In addition to new science-based knowledge, regulators need clear information on engineered nanomaterials already in commerce—what is being produced, in what quantities, how is it being handled and used, and what is known about assessing and managing possible risks?  Without this basic information, they are grappling with ensuring the safety of unknown quantities of unknown materials, being used in unknown ways.  It was exactly this information-vacuum that the UK and US voluntary data collection programs aimed to fill.  Yet by the end of its two-year duration, the UK program had received just thirteen submissions (DEFRA 2009). The US program did not fare much better. Even before it was launched, a number of experts warned that the program would be ineffective because it lacked strong incentives for industry participation and the backup of mandatory measures.  The US Environmental Protection Agency moved forward – slowly – and received only 29 submissions by the end of 2008 (USEPA 2009).  The agency’s own assessment concluded “it appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program”—an assessment based in comparing submissions with publicly available information on engineered nanomaterials being produced and used (USEPA 2009).

Against this backdrop, Canadian officials announced in January the country’s intentions to make data reporting on the production and use of engineered nanomaterials mandatory (PEN 2009).  The one-time request will be aimed at gathering information to help develop a regulatory framework and will target companies and institutions that manufacture or import more than 1kg of a given nanomaterial.  France is also in the final stages of establishing mandatory data reporting requirements.  In a move that could put the country at odds with its European neighbors, the “Grenelle de l’environnement”—a large piece of environmental legislation working its way through the French political system—includes language covering mandatory reporting on the identity, quantities and uses of engineered nanomaterials (including materials containing nanoparticles) in industry (Assemblée Nationale 2009). While these moves to make data collection mandatory are not necessarily linked directly to the UK and US experiences, there is little doubt that they were influenced by them.  Representatives from all four countries regularly share information on nanotechnology oversight through the auspices of the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials.

This move towards mandatory data reporting is a welcome one.  Given the reticence of industry to volunteer information, it will enable regulators to make decisions based on reality rather than speculation.  In principle, such data calls and any resulting evidence-based regulations will benefit industry, reducing uncertainty and providing clear operational guidelines. For instance, a recent report on strategic business issues identified regulatory and compliance risk as its number one risk faced by industry worldwide (Ernst & Young 2008).  And a survey of nanotechnology firms in the US highlighted a “lack of sufficient data to quantify risks.” as a major barrier to understanding and managing nanotechnology risks (Lindberg and Quinn 2007). The current dearth of risk data is even raising eyebrows amongst insurance companies—Lloyd’s of London and Zurich Insurance have both placed nanotechnology in their top tier of emerging risks. Canadian Underwriter 2007; Lloyd’s 2007).

Supporting effective nanotechnology risk management and oversight will require action on a number of fronts.  Well-funded and implemented research strategies are still needed that fill current knowledge gaps and inform evidence-based oversight.  Government and industry partnerships are essential to ensuring access to relevant and trusted data on nanomaterial risks.  Small firms and start-up companies need help to address potential risks and meet regulatory requirements.  Innovative data transfer mechanisms are needed between information producers and information users.  And nanotechnology-relevant regulations need to be streamlined and clarified, reducing unnecessary burdens on industry while ensuring safe use.

Progress is being made on all these fronts, but it is patchy.  Agencies including the US EPA have clarified the regulatory status of substances like carbon nanotubes; a major step towards establishing oversight clarity.  Discussions are ongoing on how new European chemicals policy under REACH applies to nanomaterials (Pelley and Saner 2009).  The OECD is coordinating international efforts to generate toxicity data on 14 nanomaterials currently in use (OECD 2008).  And research addressing specific risk-related information gaps is ramping up around the world.  Yet there is still a large and growing chasm between what is needed for effective regulation, and what current plans will provide.  If the economic and social benefits of nanotechnology are to be realized without unnecessary harm being caused, regulators need to get a move on.

Moves towards mandatory data collection are a step in the right direction.  But in the long term, safe and successful nanotechnologies will depend on strategic research, successful government-industry partnerships and responsive, transparent oversight.

_____

Nature subscribers can compare this draft with what was finally published – an interesting exercise.  I’m more comfortable with how the story develops and flows in this draft.  But I have to say, the final version – helped along by three editors – is much sharper in it’s focus and recommendations, as well as being a good bit shorter!  And on balance, I think that our ideas as presented in the final paper reflect a maturity of thought that is lacking in the draft above.

Always pleasantly surprising what a good editor (or three) can bring to a piece!

References

Assemblée Nationale (2009). Projet de loi [modifie par le Senat] de programmation relatif a la mise en oeuvre du Grenelle de l’environnement, Texte Nº 1442 transmis a l’Assemblee nationale le 10 fevrier 2009.  Paris, France. 2009.

Canadian Underwriter (2007). Nanotechnology, climate change, infrastructure among top risks. Canadian Underwriter.

DEFRA (2009). Peronal communication on the UK Voluntary Reporting Scheme for Engineered Nanoscale Materials. London.

Ernst & Young (2008). Strategic Business Risk 2008 – The Top 10 Risks for Business. Enst & Young (in collaboration with Oxford Analytica).

Lindberg, J. E. and M. Quinn (2007). A Survey of Environmental, Health and Safety Risk Management Information Needs an Practices among Nanotechnology Firms in the Massachusetts Region. Washington DC. Project on Emerging Nanotechnologies.

Lloyd’s (2007). Nanotechnology.  Recent developments, risks and opportunities. London, UK. Lloyd’s.

Lux Research (2009). Nanomaterials State of the Market Q1 2009. New York, N.Y. Lux Research Inc.

Maynard, A. D., R. J. Aitken, et al. (2006). “Safe handling of nanotechnology.” Nature 444(16): 267-269.

National Academies (2009). Review of the federal strategy for nanotechnology-related environmental, health, and safety research. Washington DC. The National Academies Press.

OECD (2008). LIST OF MANUFACTURED NANOMATERIALS AND LIST OF ENDPOINTS FOR PHASE ONE OF THE OECD TESTING PROGRAMME. Paris, France. Organization for Economic Co-operation and Development.

Pelley, J. and M. Saner (2009). International Approaches to the Regulatory Governance of Nanotechnology. Regulatory Governance Initiative, Carleton University, Canada.

PEN (2009). World’s First Mandatory National Nanotech Requirement Pending. Washington DC. 2009.
RS/RAE (2004). Nanoscience and nanotechnologies:  Opportunities and uncertainties. London, UK. The Royal Society and The Royal Academy of Engineering: 113 pp.

SCENIHR (2009). Risk Assessment of Products of Nanotechnologies. Brussels. Scientific Committee on Emerging and Newly Identified Health Risks.

USEPA (2009). Nanoscale materials stewardship program.  Interim report. Washington DC. US Enviromental Protection Agency.

Back in April, the folks at the PBS station THIRTEEN asked me to answer 13 questions on nanotechnology and the environment for their website feature Green Thirteen.   The questions ended up covering most of nanotechnology – what it is, what it’s good for, what the downsides might be, and how we might overcome potential problems to use it effectively.  With this in mind, I thought it worth posting the Q&A here as a brief nanotechnology primer…

1. What is nanotechnology?

The chemist and Nobel prize winner Richard Smalley described nanotechnology as “the art and science of making stuff that does stuff at the nanometer scale.”

Nanotechnology involves working with materials at an incredibly fine scale—around the size of the atoms and molecules that they are made of.  But the aim is to achieve something new and useful by working at this scale.

Working at the nanometer scale—where one nanometer is a mere one billionth of a meter long—it becomes possible to tap into some unique properties of matter.  Many of these properties only become apparent when small clumps of atoms and molecules are carefully constructed and used as the building blocks of larger structures.  For instance, some materials can be used in new ways when they are engineered at the nanoscale, simply because they are more versatile than non-nanoscale materials.  Other materials behave in strange new ways that enable innovative uses.  Gold, for example, becomes a highly reactive, red-colored metal when formed into nanometer-size particles.  And working at the nanoscale allows highly sophisticated new materials to be engineered that would be impossible to produce using conventional technologies—everything from super-strong materials to the next generation of computer chips to targeted drugs.

2. What are the benefits of nanotech?

The benefits of nanotechnology are incredibly broad, but generally involve making existing technologies work better, or enabling the development of  new technologies.

Many people see nanotechnology as a tool kit that allows scientists and engineers to do new things, whether they are chemists, physicists, biologists, or working in a hundred and one other fields.  In many cases, the things we use everyday don’t work as well as they could because we haven’t been able to control their structure precisely at the finest level.  But nanotechnology is changing this.  For instance, a growing number of consumer products are being improved through the use of simple nanotechnology-based applications:  Sunscreens that go on clear, but protect against harmful UV radiation; clothing that repels stains; socks that prevent the buildup of odor-causing bacteria; tennis racquets that are stronger and lighter; MP3 players that are smaller while holding more songs; even foods that are supposedly better because they have been engineered at the nanometer scale.

But these consumer products are only the tip of the nanotechnology iceberg.  Because the technology enables other technologies to work better, it has the potential to help address some of the biggest challenges facing us.  These include combating climate change, generating renewable energy, controlling pollution, ensuring access to clean water, and developing highly effective medical treatments.

As nanotechnology is used to make better products and address serious challenges, it is expected to generate jobs and money.  Some estimates put the possible market value of products that depend in some way on nanotechnology as being worth over $3 trillion dollars within the next five years.  While the significance estimates like these are sometimes hard to evaluate, there is little doubt that the “nanotechnology tool kit” will play a major role in underpinning future technological and economic development.

3. How does nanotech improve existing technologies?

Sophisticated as they might seem, many existing technologies are akin to trying to make fine jewelry while wearing boxing gloves.  Nanotechnology is the equivalent of removing the gloves—it gives us the ability to fine tune how materials and products are put together at the finest level.  For example, consider the integrated circuits at the heart of modern computers.  The power of these circuits is limited by how many components can be squeezed onto a single chip.  But it is also limited by how fast the heat generated by the electrons coursing through the components can be removed.  Nanotechnology is enabling components—individual transistors and connectors—to be shrunk to the nanoscale, allowing many more of them to be packed onto single chips.  But it is also improving the materials used to transmit heat away from these components, ensuring they don’t over-heat and stop working.

Sunscreens are another example of where nanotechnology improves an existing technology.  Ten to fifteen years go there were two options to making a sunscreen.  You could either use chemicals that are absorbed into the skin, and protect against harmful UV radiation from the sun.  Or you could use particles of materials like titanium dioxide—the same material used to make paint and some foods a brilliant white—to coat the skin and reflect the harmful radiation.  The particles were generally more effective at protecting the user and had the advantage that they lay on top of the skin rather than being absorbed into it—but they left a pasty white residue on the skin that was cosmetically unattractive.  Nanotechnology has since removed this disadvantage.  But using nanometer-scale particles of materials like titanium dioxide and zinc oxide, manufacturers have developed sunscreens that are transparent to visible light while still reflecting UV radiation—and that don’t rely on chemicals that are absorbed into the skin.  The result is highly effective products that are also cosmetically acceptable.

Almost any technology that can be thought of which relies on physical materials can be improved using nanotechnology—simply because nanotechnology provides increased control over the atoms and molecules that make up any material and determine its properties.  However, the economic, social and personal advantages of the improvements will not always outweigh the time, effort and resources needed to make them happen.

4. What kinds of industries are involved? How and where are nanomaterials made?

There are many types of industries involved in nanotechnology, ranging from small startup companies to major multinational corporations.  The types of materials being made are also very diverse.  The NanoMetro map published by the Project on Emerging Nanotechnologies gives a feel for the range and location of nanotech businesses in the US, although it probably doesn’t capture everything that is happening.  The map identifies industries using nanotechnology in the broad areas of electronics, energy and environmental applications, imaging and microscopy, tools and instruments, medicine and health, and materials.  One important point here is that nanotechnology is as much about the tools needed to see and manipulate matter at the nanometer scale—electron microscopes and scanning force microscopes for instance—as it is about creating and using new materials.

Many nanotechnology applications rely on nanomaterials—materials that have been engineered with nanometer-scale structures.  A lot of the nanomaterials currently in use are simply nanometer-scale forms of materials that have been used for many years—such as the titanium dioxide nanoparticles used in sunscreens and elsewhere.  As a result, it is common to find companies with experience developing chemicals and materials using more traditional methods beginning to develop nanomaterials.  At the same time, there are a number of smaller companies that are developing increasingly sophisticated and unique nanomaterials.  In many cases, these are being spun out of University-based nanotechnology research.

Approached to making nanomaterials are as diverse as the materials themselves.  Some of the simplest nanomaterials are made by reacting chemicals together, either in a liquid—to produce suspensions of nanoparticles—or in a gas, essentially burning materials in a controlled manner to produce nanometer-scale particles.  These are then collected, purified, and further processed before being added to products.  At the other end of the spectrum, researchers are modifying viruses, and re-programming them to build nanomaterials.  Recent research has led to new batteries that are based on virus-constructed electrodes.  In between, there are many different ways of engineering matter to form nanostructured materials that can be used to add value to products.

5. What kinds of nanomaterials are appearing in consumer goods?

Most nanotechnology-enabled consumer products currently available rely on relatively simple nanomaterials.  A survey by the Project on Emerging Nanotechnologies indicates that silver nanoparticles are one of the most the dominant nanomaterials currently in use, appearing as an antimicrobial agent in everything from clothing to cooking utensils.  Carbon nanotubes—a unique form of carbon with unusual mechanical and electrical properties—is also appearing in a number of products, predominantly in sporting goods as a way to make them stronger and lighter.  Nanoparticles of zinc oxide and titanium dioxide are widely used in sunscreens and cosmetics, while silica nanoparticles are also being used in a number of products.  In addition there are a number of products using “soft” nanomaterials, which rapidly fall apart when they have done their job.  For instance, some cosmetics use nanometer scale liposomes—very small capsules containing specific materials—to deliver nutrients and other ingredients to the outer layers of the skin.  These disintegrate when they reach their destination, delivering the encapsulated material to where it is needed.

With the exception of carbon nanotubes, these and other nanomaterials being used in consumer products tend to be nanostructured versions of materials that have been used for some time.  However, over the next few years it is likely that increasingly sophisticated and complex nanomaterials will find uses in consumer products.

6. What are the negatives of nanotech?

Like any technology, nanotechnology has its plusses and minuses.  These will generally be specific to different uses of nanotechnology.  For instance, the potential downsides of a nanotechnology-enabled memory chip in an MP3 player will be very different from using nanoparticles in food.

Because of the new and unusual behavior of many engineered nanomaterials, questions have been raised about their safety.  If something can be used in new ways, get to new places, or has new and unusual physical and chemical properties, it is reasonable to ask whether these might also lead to new ways of causing harm—either to humans or the environment.  Evidence to date is sketchy, but it does suggest that some nanomaterials might cause harm in unexpected ways if exposure occurs.  For some nanomaterials, their potential to cause harm will be negligible.  In other situations, more care will need to be taken to ensure safe use—a lot depends on whether exposure is likely, and how toxic the material is.  Common sense and current knowledge go a long way to reducing possible risks.  But more work is still needed to determine the best ways of using these new materials as safely as possible.

Other concerns about nanotechnology are more social and ethical in nature.  Will nanotechnology lead to personal rights being infringed—perhaps through ubiquitous surveillance?  Who will benefit from these emerging technologies, and who will pay the price?  At what point should the use of nanotechnology in enhancing human abilities be questioned?  These and similar questions are not unique to nanotechnology.  But they are an important component of the debate surrounding its development and use.

7. Are there any health side-effects associate with nanotechnology? (e.g. carbon nanotubes causing lung cancer, unexpected in-vivo reactions)

Nanotechnology in and of itself does not lead to health impacts, simply because it is a toolbox of different techniques rather than one specific technology.  However, some uses of nanotechnology could affect people’s health if used inappropriately.

For a material to cause harm to humans, it must first get into the body.  Once there, it’s toxicity will determine how severe any response is.  A high exposure to a low toxicity material (and many nanomaterials will have a low toxicity) may result in a negligible impact.  On the other hand, a low exposure to a highly toxic material could cause a lot of damage.

Two materials that have been researched quite a bit are titanium dioxide nanoparticles, and carbon nanotubes.  In both cases, the materials have been studied in cell cultures and in animals but not humans, and so estimating the toxicity of the materials to people is a little difficult.

Research has shown that inhaled titanium dioxide nanoparticles are more toxic than larger particles of the same substance.  In this case, size makes a difference it seems.  However, as titanium dioxide has a very low toxicity to begin with, the nanoparticles—even though they appear to be more toxic—still seem to be reasonably safe.

Carbon nanotubes appear to be harmful if inhaled, but the harm seems to depend on the type of nanotubes—and there are many types of carbon nanotubes.  Recent research has indicated that long, straight, stiff carbon nanotubes that look like asbestos fibers under the microscope, could be as harmful as asbestos if inhaled.  However, many types of carbon nanotubes don’t have the right shape for this to be a serious concern.  Other research has shown that tangled clumps of carbon nanotubes could also harm the lungs if inhaled, although it unclear how much material is needed for harm to occur.

In both these cases, the critical factor is exposure.  If exposures are low—either while making the materials or using products containing them—risks of health effects will also be low.  The good news is that it seems exposure to carbon nanotubes probably will be low—this is a material that doesn’t readily become airborne as fine fibers.  However, more research is needed to work out how low an exposure is low enough.

8. What kinds of threats to the environment might nanotech pose? (e.g.metal oxide nanoparticle toxicity to fish and frogs)

It’s not clear how harmful different nanomaterials will be if they get out into the environment, although it is clear that some nanomaterials will be more harmful than others.  Important questions that still needs answers include how much material is likely to be release, and from where; whether this material is in the form of nanoparticles, or whether it clumps up into larger particles; how far it is transported, and whether it changes as it moves through the environment; where it accumulates, how long it lasts in the environment, which plants and animals will become exposed, and what the impacts might be.

The good news is that nanoparticles from sources like fires and volcanic eruptions have been ubiquitous in the environment as long as living organisms have been around, and so they have evolved over time to deal with them.  That said, no-one is quite sure how the environment will respond to novel engineered nanomaterials—especially precisely engineered nanoparticles.

One particular potential threat that has already been raised concerns the use of nano-silver in products.  Silver is very effective at killing microbes, which is why it is being used in an increasing number of products.  But it is also highly toxic to a number of organisms as well as microbes.  What is not clear at present is what the impact of silver nanoparticles washed out of products and into the environment might be.  The amounts used may be low enough for the impact to be negligible—or they may not.  It’s a question that can’t be answered well without more information on how much nano-silver is being used, where it is being used, and the likely impacts on the environment if it is released.

9. Who regulates nanotechnology products?

There is no one agency or organization that regulates nanotechnology products.  Rather, they are regulated according to the type of product.  For instance, the US Food and Drug Administration (FDA) is responsible for drugs, food additives and cosmetics that contain engineered nanomaterials.  The US Consumer Protection Safety Commission covers consumer product safety.  The US Department of Agriculture covers food safety—except where FDA has jurisdiction.  And the US Environmental Protection Agency is responsible for chemicals and pesticides.  Each part of this patchwork of regulations and regulatory agencies has different levels of regulatory authority when it comes to nanotechnology products.

10. How much is still not known about the safety of nanotech products, and what needs to be done to fill in the gaps?

From a scientific perspective, there is still a tremendous amount that we don’t know about how to develop and use nanotechnology products safely.  Specific research question that need answers have been raised by a number of organizations, including the Project on Emerging Nanotechnologies and the US government National Nanotechnology Initiative.  There is broad agreement that if nanotechnology is to succeed—and succeed safely—there needs to be a major strategic research program that identifies and fills the outstanding research gaps.  This will require a clear set of goals and objectives, additional research funding, and greater coordination between the organizations that fund research, and those that use the information to ensure material and product safety.

That said, we are not starting out with a blank slate when it comes to using nanotechnology products safely.  Knowledge from other materials can be used to reduce potential risks in many cases, and existing regulations can be applied to nanomaterials—although their implementation may be less than perfect.  However, strategic research will be essential to underpin the long-term safety of increasingly sophisticated nanotechnology-based materials and products.

11. What kinds of recycling challenges are there for nanotech materials? What about nanolitter?

Recycling nanotechnology products presents a number of challenges.  First, there is the problem of stuff that isn’t recycled, either because no-one thinks about it, or because including nanomaterials in a product makes recycling difficult.  This leads to the possibility of nanomaterials being released into the environment as products are disposed of in landfills and slowly degrade, or are incinerated.

Where nanotechnology products are recycled there are two challenges:  Is it worth attempting to extract and reuse the nanotechnology components of the products, and how might this be done; and does the inclusion of a nanomaterial in a product make conventional recycling harder?  To illustrate this second point, imagine nanoparticles of some substance were added to plastic bottles to make them perform better, but that these nanoparticles interfered with the quality of material recycled from conventional plastic bottles.  Would it be better to separate out the nano and non-nano bottles, and how would that be achieved in practice.  The first challenge is perhaps a little easier to address, as it is unlikely that nanomaterials could be recycled from nanotechnology products in a useable state.  Rather, it is more likely that the substances forming the nanomaterials—the silver in nano-silver socks for example—would be reclaimed and used to form new nanomaterials.

12. What are some of the future uses for nanotechnology? How likely is a nano-fabricator?

The next few decades will most likely see some tremendous advances that are based in part on controlling matter at the nanometer scale.  These could well include new forms of generating and storing energy; lighter stronger materials; targeted cancer treatments; treatments for degenerative diseases; efficient ways to purify water; faster more powerful computers; computers that run on light, not electricity; biological organisms that are programmed to make new materials and devices; metamaterials that channel light in highly unusual ways.  We will definitely see a shift from the rather simple nanomaterials being used today to increasingly complex multifunctional nanomaterials.  And associated with this will be an increasingly sophisticated suite of instruments for observing and manipulating the world at the nanoscale.

Based on current research, there will further advances in developing new molecules and nanoscale systems that mimic or reflect what happens in biology (biology, after all, operates very effectively at the nanoscale).  These will move us closer to building new materials and devices molecule by molecule.  But the end result will be much closer to conventional chemistry or biology than the “nano-fabricator”—a speculative machine that can construct complex products out of their constituent atoms, much like the replicators of Star Trek.

13. How can we prevent future problems with nanotechnology? (e.g. grey goo)

Nanotechnology will come with its own set of problems—just as every technology preceding it has.  The trick here will be to have the foresight to spot the problems before they get too large and to navigate a course around them.  This is a tough task.  It will require strategic research to address plausible issues, and ways of translating the results of this research into proactive action.

Even with such an approach, there will be mis-steps.  But hopefully, with the right strategies in place, corrective action will be able to taken fast enough to prevent either major human health or environmental impacts, or the hopes of nanotechnology to address critical challenges being dashed.

In the long term, there may be challenges that are outside our current ability to comprehend the potential dangers, and how to avoid them.  Not self-replicating nanobots perhaps—the so-called “grey goo” that is more science fantasy than science fact—but other technological breakthroughs that take us places unimaginable a few years ago.  The only way to deal with such challenges is to develop institutions that are sufficiently fleet footed and forward-looking to respond to the challenges as they come over the horizon.

The one thing we cannot afford to do is to stick our heads in the sand and ignore potential of nanotechnology to do great good and possibly great harm.

These questions and answers first appeared in their original form at THIRTEEN.ORG on April 28 2009

I’m looking at an electron microscope image of a carbon nanotube – as I cannot show it here, you’ll have to imagine it.  It shows a long, straight, multi-walled carbon nanotube, around 100 nanometers wide and 10 micrometers long.  There is nothing particularly unusual about this.  What is unusual is that the image also shows a section of the lining of a mouse’s lung.  And the nanotube is sticking right through the lining, like a needle through a swatch of felt.

The image was shown at the annual Society of Toxicology meeting in Baltimore last week, and comes from a new study by researchers at the National Institute for Occupational Safety and Health (NIOSH) on the impact of inhaled multi-walled carbon nanotubes on mice.

It’s highly significant because it takes scientists a step closer to understanding whether carbon nanotubes that look like harmful asbestos fibers, could cause asbestos-like disease…

Questions were raised about carbon nanotubes and their superficial similarity to asbestos fibers as far back as 1992.  Yet it wasn’t until last year that research was published suggesting carbon nanotubes that look like harmful asbestos fibers could possibly also cause asbestos-like diseases—specifically the disease of the lungs’ lining mesothelioma.

The Poland study, published in the journal Nature Nanotechnology, indicated that development of the disease mesothelioma was theoretically possible following inhalation exposure.  But it didn’t establish whether exposure could occur to asbestos-like carbon nanotubes in practice or, if they were inhaled, whether the nanotubes could move to and penetrate the sensitive outer layer of the lungs.

Both steps would have to occur for there to be a chance of mesothelioma developing.

The current study from NIOSH seems to close the loop on one of those steps.  Some caution is needed here as the research has yet to be peer reviewed (see Richard Denison’s comments for instance).  Yet the findings are so significant that NIOSH thought it important to keep people abreast of developments before the work is finally reviewed and published.

In the study, a suspension of carbon nanotubes was introduced into the mice lungs using the pharyngeal aspiration technique, and the movement of the nanotubes through the lungs subsequently tracked.  The researchers found that some of the nanotubes migrated from the alveoli in the lungs (the tiny sacs where oxygen passes form the air to the blood) to the pleura—the delicate membrane surrounding the lungs.  As seen in the image described above, there was direct evidence that some of these needle-like fibers physically penetrated through the lung lining, into the region where mesothelioma can develop.

The researchers are at pains to point out that these data are preliminary, and are not conclusive.  The results could have been influenced by the way the nanotubes were delivered to the lungs, the amount of material applied, or the types of animals used.  Nevertheless, they demonstrate that, in principle, some forms of carbon nanotubes have the potential to migrate to the outer layer of the lungs.  And this, combined with the data from Poland et al., raises the stakes considerably regarding potential health impacts.

The data from this study will be peer-reviewed and published shortly, allowing a more critical evaluation.  But given the significance of the preliminary findings, it seems  there is an urgent need for a more extensive strategic research program to establish how harmful different types of carbon nanotubes are, and how they can be handled safely.

Without this, it’s hard to see how manufacturers will be able to make informed choices on good practices that don’t either endanger workers and users, or place an overwhelming burden on production processes.

In the meantime, the best advice seems to be: Take great care to avoid airborne exposures when working with carbon nanotubes that bear a physical resemblance to asbestos.

There are some things they don’t cover in media training, like giving interviews while suffering from stomach flu, talking to reporters thousands of miles away while on a dodgy cell phone connection, or speaking intelligently while your three-year-old niece runs rings around your legs.  It’s probably because they come under the “so bloody stupid no one would ever think to advise you not to do these things” category.  Yet sometimes we find ourselves in these uncharted waters.  Which is why Tom Mackenzie’s otherwise strong piece in today’s Guardian on nanotechnology in China ended up with less than perfect input from yours truly!

Rather than rant about the injustices perpetrated by scientific illiterates and the opportunistic press though, I’m breaking with tradition today and admitting that the fault probably lies with me…

Mackenzie’s piece addresses the rise of China as a major international player in the emerging field of nanotechnology.  It’s an important piece, and one that needs to be taken seriously. Given China’s recent track record on product safety, it rightly balances coverage of technical and commercial advances with concerns over possible health issues.  But here’s where things get a little skewed.  Tom writes:

Underlying these developments are serious safety concerns. Nanoparticles are so small they are easily inhaled and absorbed through the skin. Dr Andrew Maynard, the chief science advisor to the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington, says that some nanoparticles could be deadly. “Nothing has yet been confirmed, but there are strong suggestions that inhaling these particles could cause lung cancer or lung disease,” he says. “If carbon nanotubes behave anything like asbestos, we won’t know what the health impacts are for about 20 years, because that’s how long it can take from exposure to the onset of the disease.”

Flagging up these concerns is essential—nanotechnology is leading to novel materials that could well cause harm in novel ways, unless we work out ahead of time how to use them safely.  But the paragraph is a tad on the misleading side.  Nanoparticles are NOT easily absorbed through the skin (the skin is actually pretty good at keeping them out of the body).  And to say that some nanoparticles could be deadly confuses an already complex issue.  Yes, there are serious concerns over materials like long thin multi-walled carbon nanotubes. But plenty of nanoparticles are likely to be no more harmful than their non-nanoscale counterparts.

The issue here though is that I was Tom’s source on nanotechnology safety, and I screwed it up—I wasn’t sufficiently clear or focused to provide him with the information he needed to place the story in a sound, science-based context.

I’m not beating myself up over this (too much).  It happens, and in many cases less-than-perfect science coverage in the media gets absorbed into the bigger story and evens out over time—the biggest impacts being dented pride and the derision of one’s colleagues.

But that’s no excuse for sloppy communication. Poor science in the media muddies issues, and at worst can lead to misinformed and potentially damaging decisions being made. Yet an absence of science coverage leaves us in an even worse position.  Which means that scientists need to know how the media works, and their role in ensuring stories are founded on science reality rather than speculation.

So, mea culpa in this instance. At the end of the day, the better we as scientists communicate to—and through—journalists, the better equipped people will be to make informed judgments.

As they say, “practice makes perfect.” Next question, please?

A five-minute primer on the promise and challenge of first-generation synthetic biology

As an addendum to the previous post on synthetic biology, the following interview from the Wilson Center provides a great overview of what synthetic biology is all about, and the potential challenges of ensuring its safe development and use:

For more information, check out the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars

A new report looks at the challenges of regulating first generation products of synthetic biology.

At the J. Craig Venter Institute, scientists are on the verge of creating a living organism from “dead” chemicals, by rebooting a microbe with a new—and completely artificially constructed—genome.

At the University of California Berkeley, researchers are modifying microbes to act as highly efficient chemical plants, by rewriting their DNA.

In Cambridge Massachusetts, amateur biologists are scoring cheap laboratory equipment off eBay and Craigs List, and constructing their own designer bugs.

While all over the world, hundreds of enthusiastic undergraduates are competing to systematically design and build new DNA-based biological systems and get them operating in living cells.

Synthetic biology—the systematic engineering of biological organisms from the DNA up—is a reality now, and is destined to grow into an incredibly powerful transformative technology over the next few years.

But can we handle it?

In amidst the many questions our accelerating ability to manipulate DNA raises is one of oversight:  Are government agencies equipped to ensure the safety of new synthetic biology-related products and processes?

A new report by Mike Rodemeyer—formerly Executive Director of the Pew Initiative on Food and Biotechnology—addresses exactly this question.  Commissioned by the Woodrow Wilson Center in Washington DC, New life, old bottles takes a critical look at regulating the first-generation products of synthetic biology.

Perhaps not surprisingly, Rodemeyer concludes that once you peer under the hood (so to speak), there’s not a lot from a regulatory perspective that differentiates first generation synthetic biology from more traditional recombinant DNA (rDNA)-based technology.  Which means that where things work for rDNA, they look pretty good for synbio.

Of course, this also means that where oversight of traditional biotech is flaky, things aren’t likely to be any easier for synthetic biology.

However, the report also suggests that synthetic biology may have the potential to stretch an already stressed system to breaking point at some point in the future.  As it is, traditional biotechnology was shoehorned into a regulatory system within the US that was developed long before the practical consequences of DNA manipulation were understood.  As a result (for example), genetically engineered organisms are currently regulated as new chemical substances by the Environmental Protection Agency.

Just in case you didn’t catch that: in simple terms, the DNA within a genetically modified organism is legally considered to be a new chemical, and thus is regulated as such.  An elegant solution to fitting new technology into old rules, but one that may find run out of steam rather rapidly as synthetic biology hits its stride.

And the current regulatory framework doesn’t even begin to touch on developments that lie outside its traditional sphere of control—including a growing “biohacking” community.

Rodemeyer’s piece is more about setting out the issues and posing questions than providing solutions.  And it does this extremely well.  If you want aan excellent description of what synthetic biology is all about, the regulatory framework within which it is developing, or the challenges it presents to that framework, this is the report to read. It’s clear, it’s accessible, and it’s highly readable.

But if you insist on an overarching take-home message, it would be this (and these are my words, not his):

We are on the brink of a revolution in biotechnology that will make old biotech look like the fumblings of a toddler.  And while we may have got away with squeezing new tech into old regulatory bottles in the past, this approach isn’t going to work for much longer!  Rather, if synthetic biology is to grow into a mature, safe and accepted technology, some regulatory rethinking will be needed.

The old bottles, it seems, will last us a little longer.  But at some point they are going to burst at the seams.  And what then, if we don’t have bigger, better, more flexible containers handy?

Ten years ago to the month, one of the first research reports detailing the challenges of ensuring the safe use of engineered nanomaterials was delivered to the UK Health and Safety Executive.  The report wasn’t for general release, and you’ll be hard pressed to find a copy of it in the public domain.  But as a co-author, I have a copy skulking around in my archives.  And given it’s ten year anniversary, I’ve been browsing through it, to find out how much has progressed—or not, as the case may be!

The report focused on ultrafine aerosols, and the Health and Safety Laboratory’s ability to respond to then-current, and future, research needs.  As such it was pretty wide ranging, and focused extensively on exposure to incidental nanoscale aerosols—such as welding fume and engine emissions—in the workplace.  But it did encompass the then-nascent field of nanotechnology and “nanophase material synthesis.”  And some of these early assessments of the field bear revisiting.

For anyone interested in what was being written about the potential health and safety issues raised by engineered nanomaterials ten years ago, I’ve extracted a few sections of the report below—for the full thing, you’ll have to go to the UK Health and Safety Executive.

My apologies that the post is so long—I’m only expecting a dedicated few to plough through it.  But at the least, you might want to skip to the end to see how the research recommendations of 1999 compare to those of today—you might be surprised!

A scoping study into ultrafine aerosol research and HSL’s ability to respond to current and future research needs.
IR/A/99/03

Kenny, Maynard et al. 1999

The introduction to the report starts:

Over the past few years a number of epidemiological studies have indicated a tentative link between ambient particulate concentrations, and morbidity and mortality rates (e.g. Dochery et al. 1993, Pope 1996, Schwartz et al. 1993, Schwartz et al. 1991).  In all studies, particles with an aerodynamic diameter less than 10 µm (the PM10 fraction) have been implicated as the key agents.  The lack of an apparent association between particles of specific composition and health effects has indicated the observed effects to be due to some physical aspect of the inhaled particles.  A further link between particle size and health has been indicated by Dochery et al. (1993) who showed a more positive correlation between ill health and particles smaller than 2.5 µm than was seen than with the PM10 fraction.  The possibility of correlations between particle size and number concentration and toxicity has been demonstrated by Oberdörster et al. (1995) by exposing rats to PTFE particles ~20 nm in diameter.  At concentrations of 106 particles cm-3 (corresponding to an equivalent mass concentration of approximately 60 µg m-3) rats exposed for 30 minutes died within 4 hours. At lower concentrations a steep dose response curve was observed between pulmonary inflammatory responses and particle number.  More recent research has begun to indicate a possible material-independent link between inhaled particle surface area and selected toxicological endpoints (e.g. Lison et al. 1997). The possibility of a relationship between fine inhaled particles and ill health is now readily accepted,  although research is still at a very early stage and most published data to date are open to a wide range of interpretations.  Tentative hypotheses concerning possible mechanisms leading to toxicity have been proposed (e.g. Schlesinger 1995, Seyton et al. 1995, Donaldson and McNee 1998), and the impact of inhaling ultrafine particles on both the respiratory and cardiovascular systems have been speculated on.  The US EPA have already acted, partially as a response to earlier epidemiological studies, and introduced the PM2.5 sampling standard for environmental particulates.  Whether the UK is to follow this lead is still under discussion.  However, despite these steps, research so far has raised more questions than answers.  There is debate over the interpretation of the epidemiological studies, and the appropriateness of chosen endpoints in toxicology tests.  Contradictory experimental results are beginning to be published regarding ultrafine particle impact on health (e.g. Pekkanen et al. 1997).  There also appear to be widely conflicting views on what constitutes an ultrafine particle, with implicit cut-off points ranging from 10 µm down to a few nm!

In amongst all the current confusion is the question of whether the alleged health implications of inhaling ultrafine aerosols are of relevance to the workplace.  Much has been made of the apparent health problems amongst vulnerable sectors of the general population following environmental exposures, and the argument is followed through to the conclusion that within a healthy workforce similar problems are unlikely to be seen (backed up by a lack of evidence of severe health problems that are clearly linked to ultrafine aerosols).  However, in part the current uncertainty over the toxicity of ultrafine particles is due to the very limited information available on the nature of so-called ultrafine particles.  Inhaled particles associated with health in epidemiology studies have been very poorly defined, and even the particles used in most well controlled in vitro and in vivo experiments have been poorly characterised.  Without basic information on particle size, morphology, composition and structure, it is clearly not feasible to make value judgements on the nature of inhaled particles, either in the general environment or in the workplace. In the light of the scarcity of information on particle characteristics, the Committee on the Medical Aspects of Air Pollutants has recommended the monitoring of such parameters at a number of environmental locations (COMEAP 1996).  Similar measurements will be essential within the workplace before further speculations on the importance of ultrafine aerosols are made.

In reading this, it is important to remember that the state of the science is ten years on from when this was written—there are now a wealth of publications on the potentially health-relevant behavior of nanometer-scale particles.  Yet the framework of questions set out largely remains as relevant now as it did then.

Perhaps more interestingly, in 1999 the discussion was focused on understanding and managing the health impacts of inhaled particles, NOT whether those particles could be classified as arising from nanotechnology or not.  As a result, the document tends to be more grounded in the science of how fine particles potentially impact on health, rather than how the poorly defined field of “nanotechnology” might lead to health effects.

The report goes on to consider the generation of ultrafine aerosols in the workplace:

In general, very little is known about any aspect of ultrafine aerosols in the workplace.  There are a number of processes such as welding and soldering where intuitively one would expect large numbers of sub-µm particles.  However even in these areas, detailed measurements of particle size do not appear to have been made.  There is a general feeling that in situations where large concentrations of particles are generated, agglomeration will remove ultrafine particles from the aerosol before it is inhaled, thus removing the need to consider ultrafines. However this has not been verified, and evidence exists for significant mass concentrations of ultrafines existing close to generation sources.  Interestingly, researchers are currently speculating that agglomerates with ultrafine primary particles may have the equivalent impact on the lungs as the individual primary particles.  More is known about the products of internal combustion engines, although mainly from the view point of monitoring and reducing environmental emissions.  However very little information on the nature of individual particles in the workplace exists.

Ultrafine aerosols tend to be formed either through nucleation (in particular homogeneous nucleation), gas to particle reactions or through the evaporation of liquid droplets.  The majority of workplace ultrafine particles are likely to arise from the nucleation route, either as combustion products, or within saturated vapours arising from other sources (e.g. welding, smelting, laser ablation).  Evaporation of sub-micron and even micron sized droplets of relatively high purity solvents will result in very small particles.  Where the initial particles are highly charged, there is the possibility of any resulting fine particles exceeding the Rayleigh charge limit and fragmenting into even finer particles.  This is a recognised method of generating ultrafine particles through electrospraying.  To what extent this generation route is present in the workplace is unknown, although it is used for the specific generation of ultrafine particles during nanofabrication.  Gas to particle generation of ultrafine aerosols accounts for the majority of non-combustion particles in the environment, although again the significance of this route within the workplace is unclear.

Following current interest in nanophase technology, and the use of ultrafine particles as precursors in nanophase materials, it is likely that the next few years will see an increase in the industrial generation and use of ultrafine particles.  At present the planned generation of particles tends to be isolated to the production of ultrafine metal oxides such as TiO2, ZnO and fumed silica.  Ultrafine carbon black is also currently generated on a commercial scale. Although the full extent to which ultrafine aerosols are generated as an unwanted by-product within industry is still largely unknown, there are clear cases where the generation rate is high, such as in welding and from internal combustion engines.  Even so, data on the nature of generated aerosols in these areas are sparse.

There follows an assessment of different sources of nanoscale particles in the workplace, from welding to plastic fumes from laser cutting, and a range of other sources.  This is all interesting information, but here I want to focus on the section on ultrafine aerosol precursors in nanophase technology:

Over the last ten years, interest in the unique properties associated with materials having structures on a nanometer scale has been increasing at something approaching an exponential rate.  By restricting ordered atomic arrangements to increasingly small volumes, materials begin to be dominated by the atoms and molecules at the surfaces of these ‘domains’, often leading to properties that are startlingly different from the bulk material.  As the domains become smaller, and hence more dominated by surface atoms and surface energies, so the properties become increasingly unique from either the bulk material or the constituent atoms. So for instance, a relatively inert metal or metal oxide may become a highly effective catalyst when manufactured as ultrafine particles; opaque materials may become transparent when composed of nanoparticles, or vice versa; conductors may become insulators, and insulators conductors; nanophase materials may have many times the strength of the bulk material.  All of these effects and many more have been observed with various materials.  Such material properties that are unique to nanostructured materials that have excited both the scientific and industrial communities in recent years.

Most nanophase materials are fabricated either from the liquid state, or the aerosol state, although some routes combine the two.  The liquid route perhaps gives more control over the process in some cases.  However there is a general feeling at the present that using aerosols is an inexpensive and versatile route to constructing these materials.  Although there are many different production methods being explored, the general approach is to generate, capture and process an aerosol of particles with the dimensions of the final nanostructure.  Typically this requires the generation of particles from 1 to 2 nm in diameter up to around 20 – 30 nm in diameter, depending on the required properties of the final material.  Generation rates in research laboratories tend to be low (of the order of mg/hour), although where industrial production of nanoparticles has commenced, production rates of the order of tonnes per hour are seen.

At present, nanophase materials are an emerging technology, with the emphasis most definitely still on the research lab.  However, there is considerable commercial commitment to the field, and it is certain that as scale-up problems are overcome, the mass production of both nanoparticles and nanophase materials will increase rapidly world-wide.  When this occurs, the unique health problems associated with a unique product that can neither be treated as a bulk material or on a molecular level will have to be fully addressed.  In the meantime, there is a clear need to keep up to date with both developments in the technology, and any health concerns that may be associated with it.

Over the past ten years, commercial-scale production of nanoscale materials has moved on significantly, although perhaps not as much as some would have predicted.  Yet the issues surrounding their safety still reflect (by on large) the issues raised here.

The report summarizes the state of nanotechnology research in 1999—which I’ll skip over—and goes on to consider where the rather quaintly termed nanophase technology was heading:

The indication from the scientific press is that there are as many potential applications for nanophase technology as there are groups working in the field.  However a relatively small number of areas can be identified where commercial production of materials is most likely to be seen in the next 5 – 10 years.  To understand the commercial pressure behind the progress of nanophase technology and its likely integration into industry, you only have to consider the potential market for successful applications.  In the electronics industry in particular, the revenue arising from nanotechnology is likely to be well in excess of hundreds of billions of dollars.  In other areas, such as coatings and catalysts, similar markets exist for successful applications.  The market for ‘intelligent’ drug delivery systems, if successful, is likely to be immense.  Reflecting this, the pharmaceutical industry is currently investing in excess of $14B per annum into advanced delivery systems.

Electronic applications

The reduction in particle size has a profound effect on electronic structure as nanometre dimensions are reached, leading to a number of unique electronic properties seen in individual and groups of nanoparticles.  As an illustration, Si, which is semiconducting in the bulk solid, may be used to form nanometre sized pseudo-crystals with one of two types of atomic structure dominating its faces.  Particles with one structure are fully conducting. Those with the other are good insulators. What does this mean/what are the general implications?

Perhaps the most widely recognised electronic property of nanoparticles is their ability to act as quantum dots.  In arrays of such particles, the overall electronic characteristics are dominated by quantum effects within the particles, leading to novel applications.  For instance, quantum dot devices can be used to create high efficiency LED’s and electroluminescent plastics.  High frequency solid state lasers based on quantum dot technology are expected to form the basis of a major breakthrough in telecommunications, leading to significantly higher communication bandwidths.  High speed and high capacity computer memory will also be possible using quantum dot technology.  Success in fabricating viable quantum dot devices will bring about a major technological step within the electronics industry, leading to a $B production industry, although progress at present is limited by the need to fabricate very precise arrays of well characterised particles.  Current approaches include the use of colloids, nanolithography and aerosols.

Porous nanostructured semiconductors such as silicon have recently been shown to have electroluminescent properties.  If this can be fabricated into integrated circuits, the basis for the next generation of high speed optoelectronic computers will be laid.  Nanoparticles are also being found to lead to improved properties in resistors and capacitors.  Ultrafine conducting particles embedded in an insulating matrix have been shown to give a great range of resistances as well as showing very high temperature stability.  Similarly, the use of nanoparticles in capacitors has been shown to give a high dielectric permitivity and a low dissipation factor, making them ideal for high speed computer memory.

A particularly interesting phenomenon seen in nanophase materials is that of electrochromism; the modification of optical properties by the application of an electric field. Windows or mirrors coated with thin layers of these materials show variable light transmittance or reflection based on the magnitude of an applied electric field.  It has also been found that nanophase materials may be used to form thin transparent films with high conductivity.

A number of other important areas relating to electronics are increasingly relying on the use of nanostructured materials.  Solid state gas sensors show improved sensitivity when using films of sintered nanometre particles; high temperature superconductors have a higher performance when formed of nanostructured materials; thermocouples benefit from nanostructure and the magnetic properties of some nanostructured materials is already exploited to the full in magnetic storage media.

Coatings

Using nanophase materials to coat a wide range of substrates is being explored, and has been exploited in a wide range of applications.  Hard nanophase coatings are important in the construction industry.  The use of coatings with specific optical properties is of interest within the glass and photographic film industries.  Dry coating technology is also benefiting from nanophase materials.  It has been shown that the transport properties of large particles may be radically altered by the addition of a thin coating of fine particles of a suitable material.  For instance, coating starch grains with fumed silica results in a highly flowable powder.  In many cases, this coating need only be of the order of nanometres thick, and the use of nanoparticles in dry coating processes is already under investigation.

Chemical-mechanical polishing using nanoparticle slurries.

Surface polishing is a critical step in the processing of silicon wafers prior to semiconductor chip fabrication.  Surface blemishes are a major source of both wafer and chip rejection in the electronics industry.  By using polishing slurries consisting of nanoparticles, planarisation of wafer surfaces with fewer blemishes is possible.

Drug delivery systems.

A key goal in current drug delivery system research is the development of ‘intelligent’ systems that will deliver doses to specific sites within the body.  One approach being actively considered is the use of coated nanoparticles.  These would be capable of penetrating capillaries and being transported directly to the target site.  The coating would include the drug to be delivered, components to prevent an immune response from the body and components to achieve site-specific or condition-specific delivery.

Nanoparticle catalysts

The modified surface chemistry of nanoparticles is well recognised for its catalytic properties in many materials.  This, together with the associated surface area to mass ratio for such particles, has led to intense interest in nanostructured catalysis within many fields.

After laying out the state of the science regarding the potential risks of inhaling nanoscale particles (which has advanced considerably over the past ten years), the report summarises (on the health impacts):

There has been little work in this field to date, so it is difficult to draw meaningful general conclusions from the published data. One of the reasons for this lack of data appears to be the difficulty in generating particles of standard and known size for use in in vitro studies. Particles used in both in vitro and in vivo studies have also tended to be relatively poorly characterised. Different effects both in vitro and in vivo have been observed with different sources of ultrafine particles, so the responses measured may be a function of the particle constituents rather than the particles per se. The differences observed have been attributed to the ability of particles with a particular composition to have different levels of free radical activity at their surface. Whilst there has been some work investigating synergy between acid aerosols and ultrafine particles (see below), there has been no work investigating the synergy between ultrafine particles and other potential airborne contaminants, e.g. allergens, VOC’s and bacteria. Some of the animal models used to demonstrate toxicological endpoints require exposure regimes which are far in excess of any possible exposure in humans (e.g.  6 hours a day, 5 days a week for 3 months). Therefore, the extrapolation of such health effect data to humans should be treated with some caution.
…
Interest in possible health effects following inhalation of ultrafine particles is high at present, and research is beginning to follow this interest.  Inhalation toxicology has taken over from epidemiology over the past few years, and dominates the field at present.  Dose response relationships in rodents are being seen that indicate particle number or surface area to be more appropriate metrics than mass.  The possibility of ultrafine particles acting as vectors to transport  acids and metals to the alveolar region of the lung is also being explored.  However it is recognised that many of the current approaches being taken are lacking in various aspects, particularly regarding the significance of chosen endpoints and the characterisation of particle exposure, and a number of groups are now beginning to address these issues.  This is an area that is particularly ripe for good research proposals to sympathetic funding bodies. The need to fully characterise the particles used in exposure and inhalation tests, as well as those that people are exposed to in the workplace and environment, is well understood, although the right combination of technical skills to achieve this seems to be lacking in many establishments.  In particular there would appear to be significant scope for transferring analytical electron microscopy skills used in materials science and nanostructure analysis to the analysis of ultrafine aerosol particles.  There is also a recognised need for in-vitro test systems that allow cell cultures to be exposed to the aerosol, rather than a particulate suspension.  A small number of research groups are currently developing test systems allowing direct aerosol deposition.  Funding for fine particle research (PM2.5 sampling, and mass-based aerosol sampling) still dominates, but all aspects of ultrafine particle research are on the increase, and it is likely that the next few years will see significant funding opportunities and research in this area.  Driven by concerns over environmental exposure, together with the need to address exposure limits for nuisance dusts, there is increasing interest in examining the impact of ultrafine particle exposure in the workplace.

The report covers a lot of ground on exposure measurement and control, which I won’t duplicate here (although a lot of the information remains highly pertinent).  Instead, I’ll jump right to the end of the report, where a number of research recommendations are made.  Remembering that these are focused specifically on inhalation exposure in the workplace, they sound surprisingly contemporary, being written 10 years ago:

Full quantification of ultrafine aerosol exposure in the workplace:

• Measurement of number, size, surface area, composition, morphology, structure
• Investigation of the surface properties of workplace particles.
• Investigation of surface enrichment, role of modified surface activity below 10 nm, relevance of internal structure.
• Development of instrumentation and analytical techniques for surface area
• measurement and individual particle characterisation (Analytical Electron Microscopy)

Targeted epidemiology and toxicology studies.

• Epidemiological evidence for ultrafine particle toxicity in the workplace
• Toxicity of well defined particles, and of particles characteristic of those found in the workplace.
• Investigation of mechanisms resulting in toxic responses, in relation to the known physical and chemical attributes of workplace particles.

Instrumentation

• Identification of deficiencies in instrumentation and monitoring requirements, and development of new technologies and methods.

Control

• Reassessment of  the applicability of conventional control systems (including RPE) to reduce exposure to ultrafine particles, and the development of new approaches to exposure control.

Exposure Limits

• Assessment of current exposure limits in the light of available data on ultrafine particle toxicity, and the development of more appropriate approaches to exposure limits.

Ten years on, it is surprising how relevant this document still is.  The major issues facing the safe use of nanomaterials were reasonably clear ten years back.  And many of the research needs raised then remain today.  Progress certainly has been made since then, and an understanding of the types of nanomaterials of greater concern has increased—the 1999 report doesn’t mention carbon nanotubes for instance.  But on the flip side, this is a report that was clearly unencumbered by the politics of nanotechnology that seem to have diffused through things today

Perhaps most surprisingly though, is that governments and others are still talking about the same issues – often as if they have discovered them for the first time – without doing that much about them.  It would be churlish to ask where we might have been now if some of those 1999 recommendations were listened to.  But at least I can ask where we might be in 2019, if only we can break out of this endless cycle of re-inventing the nanotech risk report!

Endnote

Because this was an internal report, I have been careful to extract only parts of it that are of general interest and are not in any sense proprietary.  That said, there is a lot of information in the full report that would be helpful to anyone grappling with addressing and managing potential occupational risks arising from nanoscale particle exposure in the workplace.  It would be great if the UK Health and Safety Executive could release it for public use!

References

COMEAP (1996).  Non-biological particles and health.   HMSO Publications.

Dochery, D. W., Pope, C. A., Xu, X., Spengler, J. D., Ware, J. H., Fay, M. E., Ferris, B. G. and Speizer, F. E. (1993).  An association between air pollution and mortality in six U.S. cities.  N. Engl. J. Med, 329, 24, 1753-1759.

Donaldson, K. and McNee, W. (1998).  The mechanics of lung injury caused by PM10.  In: Air Pollution and Pealth.  Eds:  Hester and Harrison.  Royal Society of Chemistry.  ISBN 0-85404-245-8.  pp21-32.

Lison, D., Lardot, C., Huaux, F., Zanetti, G. and Fubini, B. (1997).  Influence of particle surface area on the toxicity of insoluble manganese dioxide dusts. Arch. Toxicol. 71, 725-729

Oberdörster, G., Gelein, R. M., Ferin, J. and Weiss, B. (1995).  Association of particulate air pollution and acute mortality:  involvement of ultrafine particles?  Inhal. Toxicol., 7, 111-124.

Pekkanen J, Timonen KL, Ruuskanen J, Reponen A, Mirme A (1997) Effects of ultrafine and fine particles in urban air on peak expiratory flow among children with asthmatic symptoms. Environ Res 74: 24-33

Pope, C. A. (1996).  Adverse health effects of air pollutants in a nonsmoking population.  Toxicology, 111, 149-155.

Schlesinger, R. B. (1995).  Toxicological evidence for health effects from inhaled particulate pollution:  does it support the human experience?  Inhal. Toxicol., 7, 99-109.

Schwartz, J., Spix, C., Wichmann, H. E. and Malin, E. (1991).  Air pollution and acute respiratory illnessin five German communities.  Environ. Res., 56, 1-4.

Schwartz, J., Slater, D., Larson, T. V., Pierson, W. E. and Koenig, J. Q. (1993).  Particulate air pollution and hospital emergency room visits for asthma in Seattle.  Am. Rev. Respir. Dis., 147, 826-831.

Seyton, A., MacNee, W., Donaldson, K. and Godden, D. (1995).  Particulate air pollution and acute health effects.  The Lancet, 345, 176-178.

Given the recent surge in 2020science readers (thanks to Lon S. Cohen at Mashable), I thought it about time I did a short retrospective—a taster for the type of stuff you can expect to read here.  So here are five pieces from the past year that cover everything from nanotechnology to synthetic biology, and ethics to the trials of being on the scientific meeting circuit—all from the perspective of emerging technologies.

Enjoy!

Asbestos-like nanomaterials – should we be concerned? It seems that when the possible downsides of nanotechnology are broached, it doesn’t take long for the “A” word to surface.  But what is the truth—if any—behind comparisons between nanomaterials and asbestos?  From January 2009.

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Nanotechnology—In bed with Madonna? How do you squeeze Madonna, John Kerry, nanotechnology and Elle magazine into the same blog?  With difficulty is the correct answer I think, but somehow they all managed to appear together in this piece from April 2008.

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Synthetic biology, ethics and the hacker culture. What the heck is synthetic biology, is “biopunk” a real word, and are the 21st century equivalents of computer hackers going to reconfigure life as we know it?  I can’t promise any easy answers, but hopefully this post from June 2008 helps set the scene.

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Geoengineering: Does it need a dose of geoethics? We’ve all heard of bioethics, but if the earth can be treated like one massive complex organism, do we need the planetary equivalent of bioethics—“geoethics” perhaps?  From January 2009.

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Enough meetings already! Ever get jealous of the scientific jet-set, swanning between “prestigious” speaking engagements in exotic places?  Don’t bother—the reality is far from glamorous, as this post from May last year tries to capture.  Fortunately, there are occasional compensations, albeit in unlikely forms!

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Last June I wrote a short piece on biohacking, prompted by a UK report on the social and ethical challenges of synthetic biology.  At the time, I though the aspirations of the nascent biopunk community naively optimistic, but potentially worrying.  Six months on, biohacking is hitting the mainstream press—and gaining momentum.

Maybe it was just a slow news day.  Maybe the subject had substance.  Either way, a story posted yesterday by the Associated Press on home-style genetic engineering has attracted quite a bit of attention over the new services.

The story revolves around Meredith L. Patterson—a 31-year-old computer programmer who is trying to develop genetically altered yogurt bacteria that glow green to signal the presence of melamine—that most recent of food-contaminants.  According to the article, Patterson

“learned about genetic engineering by reading scientific papers and getting tips from online forums. She ordered jellyfish DNA for a green fluorescent protein from a biological supply company for less than $100. And she built her own lab equipment, including a gel electrophoresis chamber, or DNA analyzer, which she constructed for less than $25, versus more than $200 for a low-end off-the-shelf model.”

And if you think that sounds far out, try the group DIYBio for size. Co-founded by Mackenzie Cowell, a 24-year-old who majored in biology in college, the Cambridge Massachusetts group is setting up a community lab where people can use chemicals and lab equipment according to AP—including a used low temperature freezer, scored for free off Craigslist!

The “role models” here seem to be the info-tech underdogs made-good.  “Defenders say the future Bill Gates of biotech could be developing a cure for cancer in the garage” notes the AP story, while a piece appearing in the Times Online notes

“Indeed, Apple and Google were created in hobbyists’ garages, and have since gone on to change millions of lives for the better while contributing billions of dollars to the global economy.”

Unfortunately, biotech is not info-tech, although the similarities are seductive—stored information that holds detailed instructions; an ability to re-write this information to control how something behaves; access to increasingly inexpensive tools for manipulating this information; a grass-roots community working outside established institutions; and the possibility of outsiders getting one over the technological elite.

But biotech—and synthetic biology in particular—differs from information technology in a number of critical areas.  This is complex stuff—ask any biologist.  And it is going to be really tough for a self-trained “biopunk” to assimilate the knowledge and expertise to make a productive contribution to biotechnology.  Then, biology is messy.  The organic is, quite literally, “organic”—meaning that it resists being ordered and marshaled in the same way as electronic circuits are.  And at the end of the day, there is no easy off-switch to living things.

As I wrote back in June,

“when a hacker causes the digital reality in their computer to malfunction through tinkering, they can simply reboot and start again.”

The trouble is, I don’t think that these differences are going to stop the biohacker community growing.  And while I have my doubts that the community will produce the Bill Gates of biotech, I do worry that they could cause a lot of harm in trying—you know after all what they say about a little knowledge…

To date, one of the greatest safety concerns over synthetic biology has been dual use—the fear that someone will use it to create a suber-bug (or similar) for malevolent purposes.  But my greatest fear is that enthusiastic—and largely uncontrolled—amateurs will create problems out of well-intentioned ignorance.  Or more worrying still, they will intentionally develop a disruptive “creation,” just because they can.  After all, look at the origins of many computer viruses.

There are some ways in which harmful garage activities could be curbed—suppliers of DNA sequences monitoring who is purchasing what for example.  But this is an area that has so far been woefully under-investigated.

A new suite of projects recently announced by the Alfred P. Sloan foundation will hopefully make in-roads into the safe development of synthetic biology.  But time is short, the stakes are high, and it’s going to take more than a few foundation grants to get this right.

In the meantime, the Meredith L. Patterson’s of this world are issuing a rallying call to the technologically marginalized—saying you too can play with the big boys and girls at the game of life.

And it won’t be long before they really can…

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Update 12/27/08:  for more information on synthetic biology, check out the Synthetic Biology Project at the Wilson Center

Navigating the minefield of airborne nanoparticle exposure

Nanotechnology—like other emerging technologies—presents a dilemma:  If you’re making new substances with uncertain health risks, how low is low enough when it comes to managing exposure?

The issue is raised in the current edition of Nature Nanotechnology by Vladimir Murashov of the National Institute for Occupational Safety and Health (NIOSH), and former NIOSH-director John Howard.  But the question has been bubbling along for some time.

And it’s an important one.  Uncertainty over safe workplace practices is bad news for nanotech businesses trying to do the right thing—especially small start-ups that don’t have the resources to work out their own bespoke solutions.  It’s not much better for regulators—as the gap between emerging technologies and solid information on their safe use widens, how do you craft new approaches to protecting people’s health and the environment?

Back in 2007, the Environmental Defence Fund and DuPont released their Nano Risk Framework… The Framework places a heavy emphasis on pragmatic exposure-based decision-making.  In a nutshell, the message was: Use the best information available. And when that runs out, use every trick in the book to come up with the best possible benchmarks for qualitatively managing risk—until better information is available.  And do all this under “reasonable worst-case” assumptions.

But the Nano Risk Framework stops short of providing practical guidelines on developing benchmarks for exposure assessment.

This gap was neatly filled by a guidance document from BSI Inc—the British Standards Organization—in January 2008.  The “Guide to safe handling and disposal of manufactured nanomaterials” (BSI PD 6699-2:2007) takes the bold step of recommending starting exposure values for four different classes of nanomaterials—benchmarks for establishing exposure decision-points in the absence of anything else.  PD 6699-2 refers to them as Benchmark Exposure Levels, and couches them in enough caveats to make the most hardened lawyer proud.  A better moniker might have been Lifeline Exposure Levels—because they quite literally throw a lifeline to anyone completely at sea when it comes to making practical decisions on making sense of airborne nanomaterial exposure measurements.

But the Benchmark Exposure Levels are based on assumptions and speculation, not hard science.  And while they are firmly grounded in recommendations within the Nano Risk Framework—using available information and reasonable worst-case solutions—they are, in the long-run, no substitute for quantitative risk assessment.

This is one of the main concerns that Murashov and Howard have about the BSI guidelines in their Nature Nanotechnology commentary.  They argue that exposure limits should be based on generally accepted principles of risk assessment—and I agree with them.  But something is needed in the interim while these limits are established, otherwise the whole emerging technology enterprise is on dodgy ground!

This is exactly what the Nano Risk Framework and PD 6699-2 address, and hopefully what additional guidance from organizations like the International Standards Organization, and even government agencies, will grapple with.

But this brings us back to the original question—how low is low enough?  Because recommendations like “keep exposures as low as reasonably practicable” simply don’t cut the mustard without some sense of how to evaluate exposure, and what the numbers mean.

PD 6699-2 makes a good stab at helping industries develop internal pragmatic guidelines on how to use airborne exposure measurements when working with new nanomaterials.  Earlier this year, I took a stab at assessing the validity and utility of the Benchmark Exposure Limits for BSI—the full assessment is available here (PDF, 168 KB).  My conclusions: the benchmark levels are far from perfect, but they are a great starting point.

Assuming that most readers will have better things to do than read through the 12-page assessment, here are the conclusions:

If effective health and safety plans are to be implemented in research laboratories and workplaces generating and using nanomaterials, guideline exposure limits are essential.  In the absence of further information, the benchmark exposure levels presented in BSI PD 6699-2:2007 appear reasonable.  Furthermore, the context surrounding the levels—which is clearly stated in the document—allows people following the recommendations to adapt the levels to their specific circumstances, depending on the best available information.  In other words, they are not binding, but rather present a clear starting point for an informed process of setting relevant exposure levels.  And thus, where evidence exists to suggest that the benchmark exposure levels are overly stringent or not measurable for a given material, it is left to the discretion of the person setting the levels to adjust the accordingly.

These suggested levels are not a substitute for workplace exposure limits, and do not remove the need for targeted research leading to the development of evidence-based limits.  But until such levels are developed, they fulfil a role that is essential to underpinning the development of safe and successful nanotechnologies.  As such, BSI should be applauded for publishing them.

The bottom line here is that industry needs practical guidelines on safe workplace practices where hard information on risks is lacking, and at some point this will mean grasping the bull by the horns and providing advice on how to measure exposures, and what the numbers mean.

Giving meaning to the numbers might simply require establishing rules of thumb for developing bespoke exposure levels.  Or it might require clear benchmark exposure levels to be suggested for different classes of materials (with suitable caveats of course).  Either way, there will be exposure data, and people will want to know what they mean, and what action to take as a result.

In the long run however, hard data are still needed to underpin quantitative and authoritative risk assessment that will supersede interim qualitative measures.  And this of course means there needs to be a research plan, plenty of funding, and a willingness to translate new information into informed oversight.

But that is a story for another day…

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The Royal Commission on Environmental Pollution report on Novel Materials

Imagine for one naïve moment that we have a pretty good handle on managing the environmental impact of existing manufactured “stuff”.  Then someone comes along and invents some “new stuff” that behaves very differently from the “old stuff.”

How can we be sure that the frameworks and mechanisms in place for preventing harm to the environment will work for the new stuff?  And where they are strained to breaking point, how do we go about fixing the system?

These are two questions addressed in a new report from the Royal Commission on Environmental Pollution—an independent British standing body established in 1970 to advise the Queen, government, Parliament and the public on environmental issues… Of course, because this is for the Her Majesty The Queen, phrases like “old stuff” and “new stuff” are conspicuous by their absence in the report—which instead addressed the rather more sophisticated-sounding issue of “Novel Materials in the Environment.”

This is, in effect, a report on the challenges of avoiding adverse environmental impacts of engineered nanomaterials.  Coming four years after the seminal report from the Royal Society and Royal Academy of Engineering on nanoscience and nanotechnologies, it reflects both how thinking on the challenges and opportunities presented by engineered nanomaterials has advanced, and actions to ensure their safe use have not!

The report itself draws on extensive interviews with experts around the world, and the depth and quality of the writing reflects this.  Perhaps not surprisingly, many of the recommendations arising from this process will be familiar to readers—the challenges haven’t changed that much over the years, and solutions still seem few and far between in many cases.

But familiar as many (not all) of the recommendations are, they are still important to the sustainable development of emerging nanotechnologies, and bear re-iterating.

And there are three in particular that are worth calling out:

Functionality: we need to focus on the properties and functionalities of specific nanomaterials as the key driver rather than treat all materials in the size range as one single class.

To my mind, this is the single most important conclusion to arise from the report.  It moves the debate on environmental impact away from generic nanomaterials—an ill-defined class of materials that have no unifying impact-relevant characteristics—towards materials that present unconventional risks due to novel behaviour.  This is a smart move, as it opens the door to addressing materials that have the potential to cause harm in ways that are not covered by conventional understanding, and avoids endless (and usually fruitless) discussions on what defines a nanomaterial.

Essentially, the Royal Commission have stated that it is not what you call a material that is important, but what it does.

Of course, there is still the issue of what defines a “novel material.”  While I’m sure this will be debated to death in certain quarters, here are some pointers from the report.  Novel materials are:

• New materials hitherto unused or rarely used on an industrial scale, such as certain metallic elements (e.g. rhodium, yttrium, etc.) and compounds derived from them;
• new forms of existing materials with characteristics that differ significantly from familiar or naturally-occurring forms (e.g. nanoforms of silver and gold that exhibit significant chemical reactivity, enhanced biocidal properties or other properties not manifest in the bulk form);
• new applications for existing materials or existing technological products formulated in a new way, which may lead to substantially different exposures and hazards from those encountered in past uses (e.g. the use of cerium oxide as a fuel additive); and
• new pathways and destinations for familiar materials that may enter the environment in forms different from their manufacture and envisaged use (e.g. microscopic plastic particles arising from mechanical action in marine ecosystems).

Information: we need to establish directed research programme on the properties and functionalities of materials in order to inform risk assessment and risk management strategies.

There’s nothing new here.  The Royal Society and Royal Academy of Engineering said as much in 2004, and I have gone on record repeatedly stressing the need for strategic research programmes.  But the fact that the Royal Commission on Environmental Pollution pulled this out as one of their three main priorities highlights how little is still being achieved in this area.

Maybe this time, someone will listen.

Adaptive management: we need to recognise the degree of ignorance and uncertainty and the time it will take to address these (insofar as they can be addressed). We also need to develop flexible and resilient forms of adaptive management to allow us to handle such difficult situations and emergent technologies.

Whichever way you look at things, conventional approaches to risk assessment and management are unlikely to work in the short term for novel materials.

Materials that behave in unconventional ways will always be developed faster than a deep knowledge of how they interact with and impact on human health and the environment.  And any attempt to avoid managing risks until a full and complete conventional risk assessment has been conducted will jeopardize innovation, people’s health and the environment.  This doesn’t mean that quantitative risk assessment needs to be abandoned—it is still the best tool we have for making evidence-based decisions on reducing and managing potential harm.  But in the short term, novel approaches are needed to managing risks, to avoid undue harm without stifling innovation.

For instance, if you are manufacturing carbon nanotubes, you cannot wait ten years for government agencies to set hard and fast exposure limits—you need guidance now on effective ways to reduce potential risks if you are to have a hope of getting viable products out of the door.  And that means taking unconventional approaches to establishing pragmatic, flexible acceptable exposure levels that are based on the best available information.

The results may not be as robust as what regulators will come up with in several years’ time.  But I can guarantee that they will help the manufacturer protect the workforce without being crippled by unnecessary investment in control and containment technologies.

This is just one example of where flexible and resilient forms of adaptive management can both protect people and the environment while enabling the sustainable use of novel materials—there are many more.

And as the Royal Commission recognizes, the increasing pace of innovation means that such innovative approaches to risk management are going to become more and more important.

We recommend that it is desirable to move beyond one-off public engagement ‘projects’ to recognise the importance of continual ‘social intelligence’ gathering and the provision of ongoing opportunities for public and expert reflection and debate. We see these functions as crucial if, as a society, we are to proceed to develop new technologies in the face of many unknowns.

This is a specific recommendation in the report rather than an overarching recommendation (as the first three points were).  But it is worth highlighting, because the interplay between society, science and technology is only going to get more complex over the coming years.  And the sustainable development of any new technology is going to have to factor in new directions in the “democratization of science and technology.”

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Overall, this is an important report, and one that should be taken seriously.  It represents an evolution in thinking rather than a step-change (with perhaps the exception of re-framing the debate over nanomaterials in terms of novel materials).  But nevertheless it makes clear recommendations that are essential to the safe and successful use of engineered nanomaterials.

But back to the “stuff.”  ‘New stuff” (novel materials) is essential to solving global challenges that the “old stuff” we have to hand simply cannot handle.  And these are big challenges that include renewable energy, global warming, water purification and disease treatment.  But as the Royal Commission on Environmental Pollution implies, new stuff requires new ways of doing business if we are going to see the benefits while avoiding potential pit-falls.

And at the end of the day, this means thinking innovatively about research, risk management and reaching out to citizens and other stakeholders.

UK Consumer Organization Which? Releases New Report

Who needs an emerging technologies blog when you have The Daily Mail?  For those of you that missed it, Wednesday’s on-line issue of the British tabloid newspaper highlighted

“The beauty creams with nanoparticles that could poison your body”

I’m so glad someone’s tracking this issue, while us folks over on the other side of the pond are dealing with the considerably less-interesting issues surrounding the incoming Obama administration.  The only trouble is, the Mail didn’t quite get it right.  In fact on a scale of 1 – 10, I’m not even sure they even make it to first base…

The article is based on a new report from the UK-based consumer organization Which? The report “Small Wonder? Nanotechnology and Cosmetics” [PDF, 3.9 MB] takes a clear-eyed view of nanotechnology-based cosmetics on the market, and asks what information is available about them, and whether or not users can be sure they are safe.

Unlike The Daily Mail story, this is an exceedingly good report.  If you are at all interested in nanotechnology and cosmetics, read it—it’s only a few pages long, but conveys the issues with clarity and style.  And by building on perspectives from industry, researchers and consumers, it presents a well-balanced overview.

The report is so accessible that it’s hardly worth summarizing it.  But here anyway are the take-home messages—Which?’s 10 point action plan:

• CO-ORDINATION:  The Government should establish a strategic stakeholder group to ensure there is effective input from all sectors of society and that the necessary measures are implemented and progress monitored.
• DEFINITIONS:  International agreement is needed on definitions for nanotechnologies.
• PRODUCTS:  The Government and EU need to understand what products are already on the market, in the pipeline or at the research stage and identifying those likely to raise most concerns based on current understanding.
• RESEARCH:  The Government and EU need to ensure that uncertainties around the environmental and health risks presented by some manufactured nano materials are urgently addressed – and ensure that research to enable this is funded.
• ASSESSMENT:  The Government and EU must provide clarity over how the safety of nano materials should be assessed given the current knowledge gaps.
• PRECAUTION:  The precautionary principle should be applied to products where there are potential risks, but where it is not currently possible to assess their safety, so that consumers are not put at risk.
• TRANSPARENCY:  Government and industry should be open about the uncertainties that some nano materials may raise, the research underpinning safety assessments as well as claims about potential benefits.
• REGULATION:  The EU needs to address the loopholes in regulations so that nano materials are included and there is clear guidance on how the regulations apply.
• INFORMATION:  The Government must ensure consumers, industry and regulators have clear information about where nano materials are being used and that any claims they make are true.
• ENGAGEMENT:  The public should be involved in meaningful discussions, at all levels, about the development of the technology, priority applications and any no-go areas.

This is a reasonable action plan, and a far cry from the scare-mongering pervading The Daily Mail story.

And unlike many of the reports that appeared in the popular press, Which? do an admirable job of fitting the story to the facts—rather than the other way around!

*At the time of posting, the report “Small Wonder? Nanotechnology and Cosmetics” wasn’t available on the Which? website.  As soon as it is up, the links in this posting will be updated.  In the meantime, the press release associated with the report can be accessed here.

Update, 11/7/08 – the report “Small Wonder? Nanotechnology and Cosmetics” can be accessed here [PDF, 3.9 MB]

[Minor edits made to the blog, 11/7/08]

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Twelve months ago today I held a bag of multi-walled carbon nanotubes up before a hearing of the U.S. House Science Committee.  I wanted to emphasize the discrepancy between the current state of the science on carbon nanotubes, and a tendency to classify this substance as the relatively benign material graphite from a safety perspective.  So it is perhaps fitting that on the anniversary of that congressional hearing, the US Environmental Protection Agency is making it clear that carbon nanotubes are in fact, a new substance—and should be regulated as such.

Carbon nanotubes are often described as sheets of graphite—the stuff that makes pencil lead black—wrapped into a tube; leading to nanometre-thin “fibres” that are incredibly strong for their weight, and highly conducting—thermally as well as electrically.  But perhaps because of this simple imagery, they are often handled as if they are graphite—especially when it comes to using them safely.

Given the amount of time and money researchers and industry are pouring into producing and using carbon nanotubes, you would think that they are at least marginally different from their flat-sheeted cousins.  In fact the differences are anything but marginal: Wrapping the sheets associated with graphite into tubes radically changes the physical chemical and biological properties of these carbon-based materials—just like re-arranging the carbon atoms that make up soot into diamonds leads to the formation of a fundamentally different material.

Yet many companies continue to persist in claiming “it’s just graphite” when questions arise over the possible health impacts of being exposed to carbon nanotubes.

But all that is about to change.  Hot on the heels of clarification from the European Commission that carbon nanotubes (and other novel forms of carbon) need to be registered under the new REACH chemicals regulations, the US EPA has clarified their position on the material.  According to a just-released notice in the Federal Register, the EPA

“generally considers [carbon nanotubes] to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory.”

In effect, this means that any company wanting to manufacture or import carbon nanotubes in the United States needs to submit a Pre Manufacturing Notice (PMN) to the EPA—unless the material can be shown to be on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory. And the chances of that are pretty slim—at present.

EPA actually established their position on carbon nanotubes back in 2007, in a document clarifying how the agency saw TSCA applying to engineered nanomaterials [available here].  But the agency’s stance was so unclear that the Federal Register notice clarifying the situation was felt necessary.  In the words of the notice just published:

“current pre-notice inquiries to the Agency and questions in public forums still indicate a lack of clarity on this issue.”

This is a significant step forward for the US EPA, and a very welcome one.  Research is continuing to show that some forms of carbon nanotubes are potentially dangerous if inhaled in sufficient quantities.  Earlier this year, Craig Poland and colleagues showed that long thin multiwalled carbon nanotubes are potentially able to cause the disease mesothelioma if inhaled.  And more recently Anna Shvedova and co-researchers confirmed that inhaled single walled carbon nanotubes can have a unique impact on the lungs of mice.

Neither of these studies suggests that carbon nanotubes behave anything like graphite if they get into the lungs.  Yet companies persist with treating this material like graphite.

I’ve previously noted that carbon nanotube distribution companies like CheapTubes Inc. consider all forms of the material as being like graphite for health and safety purposes.  In fact, as of October 31, the Materials Safety Data Sheet posted on the CheapTubes website noted of carbon nanotubes:

“This material is listed on the US Toxic Substances Control Act (TSCA) Inventory”

There is little doubt now that this is, in fact, not the case.

The EPA’s clarification will certainly help ensure that this innovative material is used safely, and its full potential is realized without causing undue harm.  There are though, perhaps inevitably, still some unresolved issues.   These include various material use and production quantity exemptions that could be used by some companies to justify not applying TSCA to their nanotubes (see for instance the series of articles by Richard Denison on TSCA and nanomaterials).  But smart companies are realizing that compliance is the best way to ensuring safe and sustainable products—which is why a number of PMN’s for carbon nanotubes have already been submitted to EPA (again, Richard Denison’s blog at the Environmental Defense Fund has useful comments on this point).

There are however two rather large flies in the ointment:

The EPA clarification doesn’t add anything to the question of where many other engineered nanomaterials stand on the regulations front.  Carbon nanotubes are chemically distinct from other forms of carbon, and so are easily defined under TSCA as news substances.  But if you take something like titanium dioxide or silver and form it into nanoparticles, current regulations make no distinction between the nano and non-nano forms of the material—even though research suggests the nano-form may be more harmful.

Just as importantly, submitting a PMN for a specific type of carbon nanotube material opens the way for that material being added to the TSCA Chemical Substances Inventory.  And once there, other companies are free to make, use and sell the material.  As Richard Denison writes,

“Once reviewed and placed on the TSCA Inventory, any company can manufacture and use the nanomaterial without even having to notify EPA it is doing so.” (unless EPA simultaneously issue a Significant New Use Rule)

Yet researchers are only just beginning to discover what might make different carbon nanotubes harmful, and how to avoid that harm.  What are the chances therefore of carbon nanotubes being added to the TSCA inventory before we have a good handle on how to use them safely?

The bottom line here is that resolving the regulatory status of carbon nanotubes is an important step forward.  But there is still some way to go before this material is regulated in a way that will encourage innovation while preventing undue harm—whether to people or the environment.

And while carbon nanotubes can perhaps leave the couch feeling a little more confident about themselves, we shouldn’t forget that there are still plenty of other materials out there that are suffering from a nano-induced identity crisis.

Is the RBC Life Sciences® nanotechnology product Slim Shake approved for use by the US Food and Drug Administration (FDA)?  According to the BBC Radio 4 science program Frontiers—broadcast on Monday evening—there may be some doubt.  But I get ahead of myself.

The US-based company RBC Life Sciences® sells a range of dietary supplements and food products allegedly based on nanotechnology—8 of them are listed in the Project on Emerging Nanotechnologies public inventory of nanotech-enabled consumer products.  As with many of the products in the inventory, it’s hard to tell whether they are truly using nanotechnology, and even harder to tell what steps have been made to assure their safety.  But Monday’s edition of Frontiers shed a little light on this issue…

Monday’s program, called very simply “Nanofoods,” provided a thoughtful and balanced perspective on the development and use of nanotechnology in the UK food industry, and included interviews with representatives from the companies Unilever and Leatherhead Foods International, as well as the UK’s Institute for Food Research, the Central Science Laboratory and the Food Standards Agency.

Presenter Sue Broom started off looking into what nanotech can do for food—from futuristic drinks with dial-up flavours to low-fat mayonnaise that still manages to taste… well, tasty.  But as the program progressed, the discussion gradually turned to the issue of safety.  And when it got there, things began to get interesting.

Asked whether nanotech food additives that can be metabolized—i.e. broken down by the body—present a greater safety risk than their non-nano counterparts, most of the interviewees suggested that they probably did not.  But Sandy Lawrie of the Food Standards Agency did caution that these assumptions really need to be tested in the laboratory.

However, when it came to nanoparticles that aren’t metabolized—nanoparticles that retain their particle-ness after being eaten and as they pass through the gut—there was less confidence that nanoscale ingredients could be assumed to be safe.  Qasim Chaudhry from the UK’s Central Science Laboratory was particularly concerned about the possibility of such particles being transported to normally inaccessible parts of the body, and perhaps causing harm because of their small size and their durability.  These concerns are echoed in a draft report on nano and food published by the European Food Safety Agency (EFSA) last week.

At this point, the RBC Life Sciences® product Slim Shake was introduced—to a backdrop of eerie music (OK, so I guess radio producers are allowed a little dramatic license in setting the sound-stage.).  As explained by Kimberly Lloyd of RBC, the Slim Shake Chocolate contains “cocoa clusters”—individual particles of silica 4 – 6 nm in diameter, that are coated with the molecules responsible for giving chocolate its flavour.  The high surface area of these nanoparticles supposedly gives an over-sized taste-hit when you drink the shake, which masks the taste of other ingredients in the drink (whatever they may be)—the point being that the Slim Shake tastes good without using too many of the ingredients that any self-respecting dieter would prefer to avoid.

The science actually makes sense, and RBC Life Sciences® should be applauded for actually coming out and explaining it.  But there is a possible problem with those nanoscale silica particles—which are described on the program as being discrete particles, not aggregates.  The folks producing Frontiers got in touch with the US Food and Drug Administration to see whether these silica nanoparticles were approved for use in Slim Shake.  This is what they got back from the FDA:

“we are not aware of any tests that have been carried out to specifically demonstrate the safety of nanosized silica for this use.  For those uses that FDA has determined to be safe, the silica is generally a fine powder but no lower limits on size exist other than those encompassed by good manufacturing practice.”

Mmm, so is RBC Life Sciences® using an unapproved food ingredient, or is life more complicated than this?

Amorphous silica has been used for decades as a food additive, and for specific applications it is Generally Regarded As Safe (a designation referred to as GRAS) by the FDA.  But GRAS status depends on how a material is used, as well as what it is made of.  And reading between the lines of the FDA statement, RBC have not established that their particular use of nano-silica as a food additive is GRAS; nor have FDA worked out whether existing determinations of silica safety apply to nanoscale forms of the material.

To be fair, much of the amorphous silica used in foods these days does have a nanostructure (the material Aerosil® is a good example).  But it is typically used as large aggregates of nanoparticles—i.e. the resulting particles in the additive are much larger than the nanoparticles they are made up from.  In contrast, RBC is claiming that their product contains individual nanoparticles—a departure that could alter the transport of the material within the body, and possibly its subsequent behavior.

Is it possible that RBC Life Sciences® think they are selling an FDA-approved product because of confusion over how existing regulations apply to nanomaterials?  I shouldn’t speculate, but I would like to give them the benefit of the doubt.  (It should also be noted that the company would be well within its rights to determine whether their nano-silica was GRAS without input from FDA—you don’t need prior FDA approval to put something like this on the market, but deciding to go it alone is often ill-advised.)

If this is the case, the faster guidance is developed by the FDA on how nanotechnology fits into existing regulations, the better.  Because as Slim Shake seems to demonstrate, nanotech-enabled foods are appearing in the US that seem to be slipping through the regulatory net.

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Postscript (added on 21st October)

For an illuminating discussion on the UK Food Standards Agency response to Slim Shake in particular, and nanotechnology-based ingredients in food in general, fast forward to 23 minutes and 35 seconds into the Frontiers program – available on the web here.

Amidst the cacophony of debate swirling around the true meaning of nanotechnology, I head a voice or reason last week.  The voice was that of Dr. Bernd Sachweh of BASF, speaking at the European Aerosol Conference in Thessoloniki.

I paraphrase, but the essence of Bernd’s point was this:

‘Nano’ is not a thing or a product.  It has no intrinsic value.  Rather, ‘nano’ adds value; it changes the properties and the worth of something that already exists.

I must confess, I rather like the idea of ‘nano’ as adding value, rather than being an entity in and of itself.  It’s hard to come up with of an example where engineering something at the nanoscale leads to behaviour or functionality that is independent of the starting material.  Rather, the great potential of nanotechnology would seem to be in taking raw materials and engineering them in ways that lead to the emergence of novel scale-related properties, which can then be used in new and innovative ways. 

But what I really like about the concept of added-value is that it provides insight into how nanotechnology might be approached from an oversight perspective.  

Just as ‘nano’ adds value to products and processes, it can also be seen as changing the potential of something to cause harm; an “added-risk” to counterbalance the “added-value.”

As soon as ‘nano’ is seen in terms of both added-value and added-risk, it becomes easier to think through some of the more knotty questions associated with using nanomaterials and nano-products safely.  

First off is the question of whether all products of nanotechnology are uniquely harmful.  

Unique nanoscale-related functionality features in many definitions of nanotechnology—this is where the added value comes from.  And it is often assumed that this unique functionality will always equate to unique risks.  Yet unlike added-value, added-risk is not intentionally built into the products of nanotechnology.  Rather, it is a by-product of the technology.  

As a result, added-risk may be significant in some cases, while in others it may be negligible.  It is even conceivable that engineering a material at the nanoscale could reduce the risk it presents to human health and the environment—leading to negative added-risk.  From an oversight perspective, functionality and potential to cause harm sometimes need to be disentangled—something that the concepts of added-value and added-risk might help to achieve.

Following this line of thought, effective nanotechnology oversight will depend on identifying whether engineering a material at the nanoscale results in added-risk.  And implementing such oversight will mean identifying, measuring and controlling those aspects of a new product or material that add to the risk—whether they are related to particle size, material surface area, surface chemistry, or other nano-relevant characteristics. 

But does nanotechnology demand a brand new set of regulations, or can the existing ones cope?  Where existing regulations work for conventional materials and products, the concept of added-risk would seem to support developing new rules on applying current regs to nanotech materials and products, rather than formulating a new set of nanotechnology regulations.  After all, if ‘nano’ has no intrinsic value or risk, what will a brand new set of regulations actually regulate?

The caveat here of course is that the existing regulations need to be sufficiently robust yet flexible to address the added-risk that some nanotechnology applications will embody.  And the evidence is that this isn’t the case for every material or product out there! (See for instance, “Managing the effects of Nanotechnology” by J. Clarence Davies)

Sticking with existing regulations, the concept of added-risk is useful when it comes to defining what is ‘nano’ and what is not from an oversight perspective.  

If the aim is for regulations (in the broadest sense) to address the added-risk rather than the added-value of nanotech materials and products, should definitions of nanotechnology be used that emphasize added-value?  Probably not.  Definitions that depend on the uniqueness and “added-value” of nanotechnology are great for guiding and inspiring research and investment that will lead to new nanotechnology-based products.  But where they do not embody the concept of “added-risk,” they are at best inadequate and at worst seriously misleading when it comes to ensuring the safety of new nanotechnologies.  For instance, gold nanoparticles can bring significant added-value to products when incorporated into heterogeneous catalysts, but if release and exposure are low, added-risk is likely to be minimal.  On the other hand, reducing the size of silver particles to 20 nanometers brings only marginal added-value from a nanotechnology perspective (the physical and chemical properties of the silver do not alter appreciably from the bulk material at this size), yet the increased possibility for release, dispersion and exposure most likely leads to significant added-risk in some cases.

For regulatory purposes, something else is needed—a point hammered home by Mike Taylor in his 2006 assessment of the US Food and Drug Administration’s ability to regulate the products of nanotechnology.  In this respect, it would be far more useful to have a definition of nanotechnology that incorporates the idea that nanoscale engineering can lead to significant changes in the potential risks associated with a material.  Something like: 

For regulatory and oversight purposes, nanotechnology is the control of matter at dimensions between approximately 1 and 100 nm, where the behaviour of the resulting material or product differs sufficiently from the component materials to lead to significant changes in potential risks to human health and the environment.

This is a definition that is based on added-risk, not added-value.  And unlike the more commonly used definitions of nanotechnology, it would encompass engineered nanomaterials where the predominant change in moving from the macroscale (or molecular scale) to the nanoscale is an increased potential for release, transport, accumulation, exposure dose, and biological impact.  

Developing an added-risk based definition along these lines (and this is just an example of what a definition might look like) would include a broad range of materials and products that have an altered risk profile because of how they have been engineered; not just those that lie within the somewhat artificial boundaries of 1 to 100 nm.  In effect, there would be no more need for lengthy arguments about whether a 99 nm particle is a nanoparticle for regulatory purposes but a 101 is not; or whether large molecules should be treated as nanomaterials.  Under such a definition, the determiner of relevance would be added-risk, NOT size.

This all sounds great.  But I do have one niggling concern about this idea of added-risk.  And that is how will it apply to the more esoteric products of nanotechnology that are coming along—the increasingly complex second, third and even fourth generation materials that have multiple components, multiple functionalities, and can respond and adapt to their environments and other stimuli.  Here we are moving from adding value to existing materials and technologies, to building brand new materials and technologies.  Will we still be able to think of oversight in terms of added-risk, or will we need to go back to the drawing board?  

That’s a tricky one and I’m not sure the answer is clear yet.  But given the current rate of progress being made in nanotechnology, we could do with some answers sooner rather than later.  In the meantime, seeing nanotechnology in terms of the added-value and added-risk it brings to materials, processes and products might just help deal with the nanotech which is out there now.

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This post first appeared on the SAFENANO blog in September 2008

As the rate of technological progress advances, are we learning the lessons of past successes and failures?  And are we applying these lessons successfully to nanotechnology? 

In 2001, the European Environment Agency (EEA) published a seminal report on developing emerging technologies responsibly.  Through a series of fourteen case studies spanning the past century, a panel led by the late Poul Harremoës examined what has gone right and what has gone wrong with the introduction of past technologies, and what can be learned about introducing new technologies as safely and as successfully as possible.  

The resulting report, “Late lessons from early warnings: the precautionary principle 1896-2000” (PDF, 1.7 MB) draws twelve “late lessons” for decision-makers faced with addressing emerging technologies [1].

Although the report was written before nanotechnology hit the big-time, the twelve lessons (listed below) resonate strongly with the challenges of fostering innovative yet responsible nanotechnologies.  So much so in fact a new commentary just published on-line in the journal Nature Nanotechnology takes a hard look at how nanotech measures up to the report’s findings.  

“Late lessons from early warnings for nanotechnology” (Hansen, Maynard, Baun and Tickner (2008),  DOI:10.1038/nnano.2008.198) systematically compares progress in nanotechnology with each of the EEA’s twelve lessons, and assesses where progress is being made, and where we could be doing better.   

And the findings?  Some of the lessons have begun to sink in, but overall, it looks like a refresher course in responsible nanotechnology wouldn’t go amiss.

In the commentary, we conclude:

“The picture is not as bleak as it could be. While progress towards developing sustainable nanotechnologies is slow, we do seem to have learnt some new tricks: asking more critical questions early on; developing collaborations that cross discipline, department and international boundaries; beginning the process of targeting research to developing relevant knowledge; engaging stakeholders; and asking whether existing oversight mechanisms are fit for purpose.

But are we doing enough? The question seems not to be whether we have learnt the lessons, but whether we are applying them effectively enough to prevent nanotechnology being one more future case study on now not to introduce a new technology. Despite a good start, it seems that we have become distracted on the way – nanotechnology is being overseen by the same government organizations that promote it; research strategies are not leading to clear answers to critical questions; collaborations are not being as productive as is needed; and stakeholders are not being fully engaged. In part this is attributable to bureaucratic inertia, although comments from some quarters – such as “risk research jeopardizes innovation” or “regulation is bad for business” — only cloud the waters when clarity of thought and action are needed.

If we are to realize the commercial and social benefits of nanotechnology without leaving a legacy of harm, and prevent nanotechnology from becoming a lesson in what not to do for future generations, perhaps it is time to go back to the class-room and re-learn those late lessons from early warnings.”

Nanotechnology is all about the future.  But it seems an occasional glance back in history is needed to set the best course of action for success.

EEA’s Twelve Late Lessons:

1. Acknowledge and respond to ignorance, uncertainty and risk in technology appraisal. 

2. Provide long-term environmental and health monitoring and research into early warnings. 

3. Identify and work to reduce scientific ‘blind spots’ and knowledge gaps. 

4. Identify and reduce interdisciplinary obstacles to learning. 

5. Account for real-world conditions in regulatory appraisal. 

6. Systematically scrutinize claimed benefits and risks. 

7. Evaluate alternative options for meeting needs, and promote robust, diverse and adaptable technologies. 

8. Ensure use of ‘lay’ knowledge, as well as specialist expertise. 

9. Account fully for the assumptions and values of different social groups. 

10. Maintain regulatory independence of interested parties while retaining an inclusive approach to information and opinion gathering. 

11. Identify and reduce institutional obstacles to learning and action. 

12. Avoid ‘paralysis by analysis’ by acting to reduce potential harm when there are reasonable grounds for concern. 

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[1]  At the time of posting, the direct link to the “Late Lessons” report was down (that link ishttp://reports.eea.europa.eu/environmental_issue_report_2001_22).  As an interim measure, I have linked to a copy of the report posted at www.genok.org.

This post first appeared on the SAFENANO blog in July 2008

Painted metal roofs are cheap, convenient, and usually very durable.  But over the past two years, a rash of accelerated ageing has blighted pre-painted steel roofing in Australia.  And intriguingly the ageing—which affects the coating—seems to be localized to small patches, taking on the form of fingerprints, handprints and even footprints.

The culprit it seems is sunscreen that is spilt or otherwise transferred to the roofing by construction workers during installation. And not any old sunscreen—this would appear to be a uniquely nano phenomenon.  But I get ahead of myself…

Pick up a bottle of sunscreen and there is a fair chance these days that it contains nanoparticles, engineered to absorb and reflect away harmful UV radiation.  Many manufacturers are introducing lines of nanoparticle-containing sunscreens as alternatives to those using more conventional organic chemicals, and it’s not hard to see why: the active ingredients in these nano sun blocks are generally more gentle on the skin than their non-nano counterparts; they are made to sit on the surface of the skin rather than penetrate into it; and if designed well, they continue to block UV radiation for several hours after application.  And of course, they go on clear, giving a product that works well and looks good.

But each year as the sun and the sunscreen come out, questions over the safety of nano-formulations are raised.  Can these nanoscale particles penetrate through the outer layers of the skin to the underlying living cells, and even the bloodstream? And if they get there, what harm could they cause?  So far, most studies suggest that nanoparticles in sunscreens stay where they are supposed to—on the skin, not in it.  Yet there is another question that has been bobbing along just under the surface for the past few years: could mixing nanoparticles, sun and moisture lead to a chemically corrosive mix that is bad for the skin?

The issue in question is photocatalytic activity.  Titanium dioxide, and to a lesser extent zinc oxide, are photoactive—they have the ability to absorb UV, and in the presence of moisture convert benign water molecules into chemically active hydroxyl free radicals.  These highly reactive chemicals could spell bad news for sunscreen users if they are generated in large amounts—eating away the components that hold the sunscreen together, and even possibly causing skin damage if they get below the surface and into cells.

Fortunately, manufacturers and users of titanium dioxide have long been aware of this propensity to generate free radicals, and have found ways of suppressing it in sunscreens. Photocatalytic activity depends on the crystalline structure of titanium dioxide.  Anatase and rutile forms of titanium dioxide have the same chemical formula but different crystalline structures. And, as it turns out, different properties. Make nanoparticles from anatase titanium dioxide, or a mix of anatase and rutile, and you have a powerful source of harmful hydroxyl radicals in the presence of water and UV. But make nanoparticles out of rutile titanium dioxide alone, and photocatalytic activity is reduced substantially.

However, even rutile titanium dioxide particles show some photocatalytic activity.  Early uses of rutile titanium dioxide as a white pigment in outdoor paint were plagued by the paint turning chalky after too much sun exposure. The problem was tracked down to hydroxyl radicals being produced and degrading the paint’s binder.  The solution: coat the particles with a material that prevents free radical formation—no more chalky paint, and coatings that will last for years in the fiercest sun.

Makers of titanium dioxide-based sunscreens use a similar trick to retain the functionality of nanoparticles while avoiding the potentially harmful photocatalytic properties. For instance Optisol—a UV blocking agent made by the company Oxonica—incorporates a minute amount of manganese into the crystal lattice of rutile titanium dioxide nanoparticles.  This doping allows the absorbed UV energy to be dissipated while virtually eliminating the formation of free radicals.  Not only does this make sunscreens using Optisol potentially safer; they also last longer in the sun, as there are fewer free radicals to break down other ingredients in the product.

So all looks rosy for nano-enabled sunscreens.  At least, it did until the publication of a recent paper.  And this is where we get back to pre-painted steel roofs. Since mid 2006, researchers in New South Wales Australia have noticed unusual defects developing in newly installed pre-painted steel roofs.  The damage is typically localized to areas of pressure contact, often taking the form of fingerprints or shoe impressions.  And it results in accelerated weathering—in one example, patches of a roof appeared to age an equivalent of 15 years in only 18 months. The culprit?  Nanoparticle-containing sunscreens, which are accidentally transferred to the roof during installation by touching or splashing.

In the paper “The interaction of modern sunscreen formulations with surface coatings,” [Progress in Organic Coatings62: 313:320. 2008] authors Phil Barker and Amos Branch systematically track down the underlying cause behind the unsightly blemishes.  Out of ten sunscreens tested—four containing no nanoparticles, five containing titanium dioxide nanoparticles, and one containing zinc oxide nanoparticles—all but one of the nanoparticle-based sunscreens consistently degraded samples of pre-painted roofing surface exposed to sunlight for 12 weeks.  In contrast, the non-nano products had no obvious deleterious effect.  In the worst case, the roofing lost over 85% of its gloss (a measure of degradation) in just six weeks.

Digging a little deeper, Barker and Branch pinned the effect to nanoparticles in all but one sunscreen acting as photocatalysts, and generating hydroxyl radicals in the presence of UV radiation and water.  Despite assumptions that nanoparticles in sunscreens are engineered not to produce significant amounts of free radicals, these products were generating them fast enough to significantly damage roof coatings in a matter of weeks!

So have we had the wool pulled over our eyes?  Are these supposedly benign nano-sunscreens we are slathering on our skin adding to our wrinkle-count before our time, and perhaps more besides?

Before jumping to conclusions, it is worth taking stock of what is known, and what is not.  While the study showed all but one of the nanoparticle-based sunscreens had some adverse effects on the roofing, these effects varied greatly between products.  The sunscreen using nano-zinc oxide particles led to a 55% reduction in gloss over 12 weeks, while in the worst case, a sunscreen containing 4% titanium dioxide led to a 95% reduction in gloss over 12 weeks.  Assuming that the reduction in gloss is associated with the formation of hydroxyl radicals (and the evidence presented by Barker and Branch arising from a logical sequence of laboratory experiments is pretty convincing), there is still uncertainty over how harmful these would be when generated on the skin of a sunscreen-user.  To cause damage, the hydroxyl radicals would need to penetrate deep into the skin and into cells before loosing their potency, and if the nanoparticles stay on top of the skin where they are supposed to, significant penetration may not occur.

Then there is the anomalous nano-sunscreen that didn’t show an appreciable effect.  A nifty piece of X-ray diffraction analysis in the Barker and Branch paper showed that the titanium dioxide nanoparticles in the roof-damaging sunscreens were an anatase/rutile mix, while the nanoparticles in the benign sunscreen were comprised of rutile titanium dioxide alone.  Clearly crystalline form matters, as Oxonica realized when they selected the less-active rutile form of titanium dioxide as the basis for Optisol.

This study demonstrates that it is possible to create nanoparticle-based sunscreens that do not generate significant amounts of hydroxyl free radicals.  But the bottom line here is that some nano-based sunscreens are being sold (in Australia at least) that contain photoactive nanoparticles which generate hydroxyl radicals in the presence of water and sunlight.  This raises questions about the impact of these products on users over time and, perhaps more significantly, their impact on the environment.  A photocatalytic titanium dioxide particle released into the environment will continue to generate hydroxyl radicals as long as it is exposed to UV radiation—because this is a catalytic process, the particle is not destroyed in the process, but just carries on doing its stuff; day after day, year after year.

But perhaps the biggest question here is one of regulation.  In the US, the Food and Drug Administration does not currently discriminate between anatase and rutile titanium dioxide particles in sunscreens, or doped and un-doped particles [Sunscreen Drug Products For Over-The-Counter Human Use: Final Monograph.  May 21 1999.  PDF, 144 KB].   This may change following further consultation on the use of nanoscale titanium dioxide and zinc oxide in sunscreens [see Sunscreen Drug Products For Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Proposed Rule.  August 27 2007.  PDF, 424 KB].  But in the meantime, what is to stop manufacturers using potentially harmful forms of titanium dioxide in sunscreens?  And how will consumers be able to distinguish between companies that have got it right, and those that have not?

It seems that if we are not careful, nano-sunscreens could be making their mark on more than just pre-painted steel roofing.

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This post first appeared on the SAFENANO blog in June 2008

Why nano?  Why care?  For non-nanotech initiates, an obsession with nanotechnology must sometimes seem a bizarre occupation of the sad and lonely.  And even within the nanotechnology community, who hasn’t had occasional doubts over the legitimacy of singling out “nano” as something special?  Yet occasionally a piece of work comes along that helps put things back into perspective.  For me, a paper just published on-line in the journal Nano Letters did exactly that.

To be quite frank, the paper’s title is not what I would call inspirational.  But dig below the surface, and you unearth an object lesson in what makes nano so intriguing, and why taking a fresh look at possible health and environmental impacts is so important.  First the science though.

The Science

The paper in question is “Controlled Manipulation of Giant Hybrid Inorganic Nanowire Assemblies” by Fung Suong Ou, Manikoth M. Shaijumon, and Pulickel M. Ajayan, published on-line in Nano Letters, May 29 2008.  Unfortunately, a subscription to the journal is needed to view the paper, but the supplemental information is freely available (here), and well worth looking at.  

In brief, the authors used a nanoscale fabrication technique to construct long, straight, carbon nanotubes capped with gold nanowires.  Think “magician’s wand” with the nanotube as the stem and the gold as the white tip, and you will get the idea.  The nano-wands (for want of a better description) were between 100 nm and 150 nm wide, and over 100 mircometres (100,000 nm) long.  Micrographs in the paper show rafts of uniform-length nano-wands stacked side by side, with individual wands fraying off at the edges.

But this is where things get interesting.  These long, straight artificial rods were designed to have one end that was hydrophobic (water-repelling; the carbon end), and one end that was hydrophilic (water-seeking; the gold).  When dispersed in water, these wands formed a uniform suspension.  But when an organic solvent—dichloromethane (DCM)—was added to the mix, the nano-wands assembled into shells around the DCM, with the black carbon nanotubes facing in and the gold tips facing out.  With a bit of shaking and ultrasonic agitation, one large gold-coloured sphere was formed, separating the DCM from the water.  Reversing the process by suspending the nano-wands in DCM and adding water, a large black sphere assembled; separating the water from the organic solvent.  Black, because in this case the carbon nanotube “tails” were pointing outward.

Using the same fabrication technique, the researchers demonstrated a couple of other tricks.  By adding a band of the metal nickel below the gold tip, the nano-wands could be made magnetic—so now the spheres separating the two liquids could be moved around using a magnetic field.  And by adding an ultraviolet light-degradable hydrophobic chemical to the gold end of nano-wands, spheres were constructed that quite literally turned inside-out under UV irradiation.

The Promise

Nanotechnology is all about functionality—making materials and products that behave in new and unusual waysbecause they have been engineered at an incredibly fine scale.  This new and unusual behaviour might in some cases be due to the unusual physics and chemistry of small clusters of atoms (such as the size-related fluorescence of quantum dots).  But it can just as easily arise from engineering a material at such a fine scale that it can be used in new ways (such as making antimicrobial silver particles small enough to be incorporated into a miscellany of products); or constructing materials at the nanoscale with such sophistication that new properties emerge (multi-functional nano-therapeutics for instance).  The nano-wands are most definitely in the latter categories—their functionality arises from their smallness and sophistication.  

The important point here is that, while size matters, performance matters more.  And so while these nano-wands are technically larger than the 100 nm limit usually (and somewhat arbitrarily) imposed on nanotechnology, they nevertheless represent an ability to create a novel functional material through sophisticated engineering at a very fine scale.

And what functionality!  This is a crude material compared to what could be achieved using similar construction techniques, but even so the nano-wands behave in a most unusual way.  Functionally, they are reminiscent of polar molecules, and the spheres they form are analogous to micelles—“capsules” formed by organic molecules with opposing hydrophobic and hydrophilic ends.  But by engineering them at the nanoscale out of inorganic materials, structural and functional possibilities open up that are way beyond the realm of chemistry alone.  

It is easy to imagine how this material could be used to encapsulate and collect chemical spills in the environment.  Or deliver drugs to where they are needed in a very targeted way (only releasing their payload by disassembling when the right signal is received).  Yet the work of Fung Suong Ou and colleagues hints at much greater things.  Using the same basic technology, there is nothing to prevent the construction of multi-component nanomaterials that can assemble and re-assemble in many different ways, depending on their environment and the stimuli they receive.  As the paper’s authors’ conclude, 

“This controlled engineering feat at the nanoscale that allows well-controlled assembly and manipulation could lead to the creation of smart materials that are a cornerstone for the development of nanotechnology-based applications.”

The challenge

But stimulating as the science is, this paper is also an object lesson in why new thinking is needed on possible risks to human health and the environment, if such technologies are to succeed.

First and foremost, the paper comes hot on the heels of Poland et al.’s study linking some forms of multi-walled carbon nanotubes to precursors of mesothelioma—a disease more usually associated with asbestos exposure.  Poland’s research suggests that carbon nanotubes which are thin, longer than 15 – 20 micrometres, straight, and dispersible, could lead to the disease if inhaled.  The nano-wands in the Ou et al. paper are around 150 nm in diameter, something over 100 micrometres long, straight, and apparently dispersible—in other words, exactly the types of fibres which Poland’s work suggests more research is needed on before the possible health implications are understood.

It’s too early to tell whether Ou’s nano-wands will have their own unique risk-profile.  But their inevitable comparison with the nanotubes used in Poland’s study and the possibilities of dispersive use hinted at in the accompanying press release do raise important questions about their safety.  The important point here is not that this particular material might show harmful behaviour, but that there is always the chance that novel behaviour can lead to unanticipated harm—unless the right questions are asked early on.  And this most definitely requires new thinking on what those questions are, and how they might best be answered.

The second object lesson in new challenges concerns regulations.  Unless used as a drug or pesticide, substances are typically regulated according to their chemical makeup.  It’s an approach that was developed at a time when the terms “chemical” and “substance” were interchangeable.  But Ou’s nano-wands challenge this paradigm.  

These nano-wands and other hybrid substances have no unique chemical identity, and so potentially slip through the net of many existing regulations.  Yet they display a functionality that depends on their physical form and complex makeup, which is not predictable from their chemical components.  And regulations are needed that recognize this.  If effective approaches are to be developed to ensure the safe use of this emerging class of material, new thinking is needed on how substances are classified and regulated.

The bottom line

Why nano? As Ou’s work shows, we can potentially do things with nano that are way beyond any other technology at our disposal.  And when nano is combined with other technologies like biotech and information tech, the possibilities become endless.

Why care?  Because nano will change your life, whether you like it or not.  And you might want to make sure that it is a change for the better, not for the worse.

And the nano-wands?  These have tremendous potential as an innovative new material.  Lets hope that their development is matched by equally innovative thinking on using them safely.

Further resources

Paper: Controlled Manipulation of Giant Hybrid Inorganic Nanowire Assemblies

Supplemental Material to the paper

Managing the Effects of Nanotechnology.  J. Clarence Davies

Paper: Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study

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This post first appeared on the SAFENANO blog in May 2008

Mix carbon nanotubes and asbestos together (metaphorically) and you get an explosive mix—at least if news coverage of the latest publication coming out of Professor Ken Donaldson’s team is anything to go by.  The research—published on-line today in Nature Nanotechnology—is the first to explicitly test the hypothesis that long carbon nanotubes behave like long asbestos fibres in the body.

In brief, the study (which I was a co-author on) used an established method to test whether a fibrous material has the potential to lead to the disease mesothelioma—a cancer of the outer lining of the lungs that can take decades to develop following exposure.  In the method, samples of material are injected into the abdominal space of mice, where inflammation and the formation of granulomas in the lining tissue (the mesothelium) are studied over a seven-day period.  Previous research has established that the combined presence of fibres, inflammation and granulomas is a very strong indicator that mesothelioma will occur in the long-term.  While the method uses lining of the abdominal space, it is highly predictive of what happens in the same tissue surrounding the lungs, if it is exposed to durable fibres.

Five materials were tested in this study: short amosite asbestos fibres, long amosite asbestos fibres, short and/or tangled multi walled carbon nanotubes (two samples), long straight multi walled carbon nanotubes (two samples), and carbon black (compact graphite-based particles.  The results: fibres longer than 15 micrometers to 20 micrometers (whether asbestos or carbon nanotubes) led to a positive response; short/compact particles did not.

This is the first study to demonstrate that carbon nanotubes that physically resemble harmful asbestos fibres, can also behave like harmful asbestos fibres.

What the study does not address is whether exposure to long straight carbon nanotubes will occur or, if it does, whether these fine fibres will reach the mesothelium surrounding the lungs, and go on to cause mesothelioma.

But the results are sufficiently compelling to suggest urgent action is needed if we are to prevent a long lasting legacy of harm from some forms of carbon nanotubes, and ensure the emergence of safe and trusted carbon nanotube applications.

First and foremost, targeted research is needed to validate this study, assess the magnitude and nature of likely carbon nanotube exposures—from material production to product disposal—and evaluate whether inhaled nanotubes can work their way to the outer lining of the lungs.  The current U.S. federal strategy for nanotechnology-related environmental, health and safety research (PDF, 2.2 MB) does not specifically address the health impacts of carbon nanotubes (despite a recommendation from the UK Royal Society and Royal Academy of Engineering in 2004 to carry out exactly this type of research).  Perhaps it’s time to rethink what is important here.

But action is also needed now to ensure carbon nanotube exposures to workers and users are kept as low as possible.  This means developing appropriate exposure measurement methods, applying effective control and containment protocols, and agreeing on benchmark exposure levels to use in the absence of more formal exposure limits.  The recent BSI Guide to safe handling and disposal of manufactured nanomaterials (PD 6699-2:2007, see also“Safe nanotechnology in the workplace: A practical guide”) recommends a benchmark exposure level of 0.01 fibres/ml for carbon nanotubes in the absence of any other information—this would seem to be good advice for long carbon nanotubes, until more is known about their exposure potential and hazardous nature. Long multi-walled carbon nanotubes can currently be purchased from outlets like CheapTubes Incorporated for as little as 40 cents a gram (as long as you by them in kilogramme quantities), yet the health and safety advice still assumes these are as harmless as graphite—this has to change.

And thirdly, action is needed to ensure transparency—making sure regulators, industries and consumers know which types of carbon nanotubes are being used, where they are being used, and what precautions should be taken to ensure safe use.

Carbon nanotubes have great potential as a unique material that can be used in many unique and beneficial ways—from reducing our environmental impact to curing diseases.  But mis-steps now could easily undermine trust in this nascent industry, and prevent the material’s potential from being realized.

The comparison with asbestos is firmly grounded in the physical resemblance between certain forms of the two materials, and this alone should stimulate clear action to ensure safe use.  But the health impacts of asbestos exposure still resonate through society—deaths from asbestos-related disease are not expected to peak for another ten years—and the mere suggestion of similarities between nanotubes and asbestos fibres could cause investors and users to shy away from this new technology unless there are clear assurances that health and safety concerns are being fully addressed.

Widespread pickup in the media of the current study suggests that people care about carbon nanotubes, and whether they are safe.  The good news is that we still have time to ensure they are used safely—but only if we act now and act fast.

Additional Resources

Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study.  Poland et al. (2008). doi:10.1038/nnano.2008.111

Carbon nanotubes display asbestos-like behaviour – a SAFENANO commentary by Ken Donaldson

Project on Emerging Nanotechnologies

Nanotechnology consumer products inventory

International Council On Nanotechnology backgrounder on multi walled carbon nanotunes and mesothelioma

NIOSH Science Blog

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This post first appeared on the SAFENANO blog in May 2008

“Nanotechnology” as an overarching concept is great for sweeping statements and sound bites, but falls short when it comes to real-world decision-making.  As nanoscale technologies are increasingly used in everything from antimicrobial socks to anti-cancer drugs, perhaps its time to rethink how we talk about the myriad diverse technologies that fall, slip or are forcibly squeezed under this all-encompassing banner.

At last year’s Bernstein Symposium, I had the pleasure of listening to National Public Radio science journalist Richard Harris talking about the latest greatest technology-not nanotechnology, but yellowtechnology.  A rather liberal re-interpretation of Richard’s lecture goes something like this: 

“Yellowtechnology is the next technological revolution-if you think biotechnology and information technology are cool, just wait until you see what yellowtech can do.  Yellow makes everything faster; smarter; hotter.  Want more powerful power tools?  Just add yellow.  Got to have a faster, sleeker sports car?  Make it yellow.  And everyone knows that yellow is the surest route to making good food great-from M&M’s to mustard.  

“The beauty of yellowtech is that it reflects what nature has been doing for millennia.  Daffodils, the sun, canaries-everywhere you look, the natural world is exploiting yellowtech.  In developing this new technology we are simply treading in the footsteps of mother nature, and producing new products that are environmentally friendly to their core.  In the twenty first century, yellow is the new green.

“But care is needed-who hasn’t experienced the dark side of a carelessly discarded banana skin? Yellowtech may be the next best thing, but we need to learn how to use it responsibly.  We need new research to discover where yellow might be harmful.  We need regulations to ensure safe use.  And we need transparency so we know where yellow is being used, and what the consequences might be.  Is your yellow rubber duck safe? If not, how would you know?”

[long pause]

“I’m sorry what was that?  I was supposed to be talking about nanotechnology, not yellowtechnology?  OK, let’s start again…

“Nanotechnology is the next technological revolution-if you thought we could change the world with biotechnology and information technology, just wait until you see what nanotech can do…”

The above delivery is inspired by rather than transcribed from Richard’s lecture (A video of the original lecture can be viewed from here), but it does encapsulate a critical point-a grand idea that is sufficiently broad can be used-or abused-to almost any purpose, and in the end becomes meaningless.

The grand idea of nanotechnology has unquestionably stimulated much new science and technology around the world, and has energized the quest to develop scientific knowledge targeted at improving quality of life.  Yet when it comes to identifying its benefits, addressing its risks and overseeing its safe use, it is as slippery (and some would argue as meaningless) a concept as yellowtechnology.  

Under this grand idea, there is the temptation to redefine the most trivial advances as “nanotechnology” in order to emphasize the scale and magnitude of the new technological revolution. But there is also the lure of mixing and matching risks-either to over-stress the dangers of the new technology, or to justify a ragbag of studies as a coherent risk research strategy.  And so it becomes conceivable that consumers might reject new technologies for energy harvesting because a nanotech-based toothpaste gets a bad rap (a hypothetical example), or a multi-million dollar materials characterization facility is justified on the grounds of what it might hypothetically contribute to preventing occupational exposures.

As businesses, governments and consumers are faced with making increasingly sophisticated decisions on how nanotechnology is and is not used, it becomes more important to differentiate between the grand idea, and the products and processes it leads to.  

This process of “decoupling” is the only way of ensuring intelligent and informed conversations about product-specific benefits and risks.  

By decoupling different expressions of nanotechnology from the overarching concept, it becomes possible to make informed decisions on the resulting nanotechnologies, rather than the idea of nanotechnology.  Focusing on the products of the grand idea, rather than the idea itself, regulators can begin to talk about how a specific substance (like nanoscale silver) might present new challenges, without being sidetracked by other unrelated nanomaterials. Or consumers can begin to have informed conversations about the pros and cons of certain products-say, nanoscale electronics-without being baffled by claims and counter-claims associated with unrelated “nanotech” products.

The grand idea of nanotechnology has taken such firm root around the world that decoupling it into its component technologies and products will not be easy.  But if we are to avoid nanotechnology becoming as farcical asyellowtechnology, it’s something we need to do-the sooner the better.

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This post first appeared on the SAFENANO blog in May 2008

The author Neal Stephenson got it wrong—at least, if this week’s nano-news is anything to go by!   In his landmark 1995 novel “The Diamond Age,” Stephenson described a future built on nano-innovation.  But thirteen years later, nanotechnology seems to be ushering in “The Silver Age.”  And to some it’s looking a little tarnished.

First we had Cal Baier-Anderson’s entry on the Environmental Defence Fund nanotech blog, calling claims that bacteria cannot develop resistance to silver “not only false, but dangerous.”  Two days later, the International Center for Technology Assessment (CTA) filed a petition with the USEPA requesting the agency regulate nano-silver products as pesticides.  And to top it all, Washington Post science writer Rick Weiss completed the hat trick with a story on nano-silver in Friday’s edition of the paper.

Silver is currently topping the charts in the Project on Emerging Nanotechnologies consumer products inventory—136 entries out of 610 as of May 2nd.  Nano-silver is clearly a technology of the moment, and manufacturers are flocking to use the antimicrobial nanoscopic particles in anything they can—from socks to toothpastes to fluffy toys.  CTA claim the sole reason for using nano-silver in these products is as an agent for killing microbes and as such, it should be classed as a pesticide. But that would make life difficult for opportunistic manufacturers looking to get onto the nano bandwagon.  Perhaps this is why some companies are using the technology, but being circumspect about who they tell (check out “Benny the bear, and the case of the disappearing nano”).

Silver is a powerful antimicrobial.  Yet widespread and indiscriminate use of silver nanoparticles raises clear concerns: is it harmful to people, will it be released and accumulate in the environment, will it harm environmental organisms, and will it lead to silver-resistant strains of bacteria?  The jury’s still out on most of these questions, which suggests more research is needed—and fast.  A recent study by Paul Westerhoff and Troy M. Benn of Arizona State University demonstrated that ordinary laundering of silver nanoparticle-laden socks can wash the particles out.  But where these particles go and what they do, once out in the environment, is largely unknown.  

And what about microbes building up resistance to nano silver over time?  In a recent article Lucian Lucia, an associate professor of chemistry at North Carolina State University, suggested that bacteria cannot build up resistance to silver nanoparticles as they can to antibiotics: “That’s the beauty of silver… [t]here’s no way to develop a resistance to it.”  Yet Cal Baier-Anderson’s cites a series of convincing studies that challenge this claim.

Silver is a useful weapon in the fight against infection, and nano-silver extends its reach in this arena.  But using it without caution would seem unwise.  Surely it’s time to discover the rules of safe use, and to avoid applications where the benefits are dubious and the risks uncertain.  At least; if we want a nanotechnology age without tarnish.

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This post first appeared on the SAFENANO blog in May 2008

The most recent estimate from the U.S. National Nanotechnology Initiative (NNI) puts nanotechnology risk research investment at $68 million for 2006 (the only year complete figures are currently available for—apparently).  Yet theProject on Emerging Nanotechnologies (PEN) has just completed its own assessment—and could only find $13 million associated with research projects primarily focused on addressing nanotechnology risk in the same year.  What gives—are the feds indulging in a bit of creative accounting; or have PEN forgotten the basic rules of arithmetic?

Let’s be honest, I’m not a great fan of bean-counting.  Evaluating research in terms of dollars invested (or Pounds or Euros) is a crude tool at the best of times.  But when it comes to assessing investments and returns, the fact is that bottom-line figures count.  

Faced with counting research dollars, organizations have two choices: use the figures to justify past performance, or employ them to inform future actions.  The former is the easy option—matching what was invested to what was done, rather than what should have been done.  But using past spending as a feel-good exercise is a disaster when it comes to future planning—because the assessment is invariably based on wishful thinking rather than reality.

Admittedly, the U.S. National Nanotechnology Initiative has taken a structured approach to evaluating investment in risk research.  As outlined in its recently-published nano-risk research strategy [PDF, 2.2 MB], nanotechnology risk research needs have been divided into five overarching areas; each consisting of five specific research priorities.  Research funded by the federal government in fiscal year 2006 (running from October 2006 to September 2007) has then been evaluated in terms of its relevance to these research priorities.  

The result: 246 projects that were identified as addressing nanotechnology risks in 2006.

From the report’s executive summary:
 

“In FY 2006, the Federal Government invested $68 million in 246 projects at seven agencies.  Although research categories were not prioritized with respect to each other, there is consensus among members of the NEHI Working Group that research in the Instrumentation, Metrology, and Analytical Methods category is cross-cutting, supporting research in every other category, and therefore is generally a high priority. Among the five research categories, the distribution of projects and spending was: 78 projects ($26.6 million) in Instrumentation, Metrology, and Analytical Methods; 100 projects ($24.1 million) in Nanomaterials and Human Health; 49 projects ($12.7 million) in Nanomaterials and the Environment; five projects ($1.1 million) in Human and Environmental Exposure Assessment; and 14 projects ($3.3 million) in Risk Management Methods. In short, the analysis demonstrated that the Federal Government is supporting more EHS research than has been previously identified, and the research is well-distributed across key priority areas.”

$68 million in one year sounds a lot.  But what does this mean—that all of these projects were dedicated to addressing critical knowledge gaps in the quest to develop safe nanotechnologies, or that 246 projects could somehow be justified as having some relationship to the five research categories?  The distinction is crucial—on the one hand you have a strategically important assessment; on the other, a justification for past actions.

Assessing the value and relevancy of research is not easy—as well as projects dedicated to addressing risk, there are those where risk research is a major component of a more general nanotechnology project; or projects supporting research that could be relevant to understanding risks—if it was applied in the right way.  

Reading through the government’s strategy document, I suspect that the NNI lumped all of these different types of research together without making clear distinctions.  For instance, when assessing research relevant to nanomaterials and human health, the NNI report states:
 

“Much of the research reported for FY 2006 focuses on medical applications. While this focus does contribute to the overall body of knowledge for human health effects, more systematic, targeted study of classes of nanomaterials and the relationship of their physical and chemical properties to biological response would provide better integrated data sets for risk assessment and risk management. These efforts should build upon the existing research whose primary focus is human health and safety.”

But how were these applications-focused projects evaluated in terms of their relevance to risk?  How well does the reported $68 million reflect research that will provide clear answers to well-defined risk questions, and to what extent (if at all) were nano-applications projects used to pad this figure?  Unfortunately, the report does not divulge this—just as it does not list project-specific funding that would enable an independent evaluation of the report’s assessment.

It is this lack of transparency that prompted the PEN analysis of risk-research funding for 2006.  Staring with the 246 projects listed in the NNI document (and removing those projects listed more than once), we matched the projects—where possible—to publicly available information on funding.  We then assessed the summary of each project (available on-line here), and determined whether the research being undertaken was highly relevant to addressing nanotechnology risks, substantially relevant, had some relevance, or was only marginally relevant.  We also classified the research in terms of whether it was primarily focused on engineered nanomaterials, or nanomaterials from other sources (incidental or naturally occurring).

Just to clarify; projects primarily focused on addressing nanotechnology risk (such as toxicity and exposure studies) were classed as being highly relevant.  Those focused on applications (or basic research), but with a major component addressing risk were classed as substantially relevant.  If a project was primarily focused on basic research or nano applications, but was generating information of direct use to understanding and addressing risks, it was classed as having some relevance.  And finally, research that could conceivably be useful to addressing risks—but only if there was increased investment in applying it to environmental health and safety implications—was classed as having marginal relevance.

The results of this exercise are freely available in the PEN Nanotechnology Environmental Health and Safety Research inventory – accessible here.  Although reproducing our assessment of the NNI-listed research is tough because the inventory contains a number of relevant projects that the federal government missed, the data can be searched and evaluated to give a reasonably clear idea of risk-relevant research funded in the U.S. and many other countries. 

Our classification of the NNI-listed projects is also available in testimony to the U.S. Congress House Committee on Science and Technology hearing on the National Nanotechnology Initiative Act of 2008, held 16th April 2008 [testimony available here].  This list contains estimates of annual funding for each project, and may be used to verify the PEN assessment of the NNI’s 246 risk-relevant projects.

And the assessment is revealing.  We could only find $13 million invested in research projects that were highly relevant to nanotechnology risk and received funding in 2006.  These are the projects that directly address environmental, health and safety impact. 

Including substantially relevant projects in the assessment brings this figure up to $29 million—still a little shy of the NNI-reported $68 million!

If these figures look low, take a look at the projects listed in Wednesday’s testimony and see whether the categorization looks reasonable.  To whet your appetite, here are examples of listed projects from each category:

Highly relevant: Example – Monitoring and Characterizing Airborne Carbon Nanotube Particles (NIOSH, Est. funding $400,000 over 3 years). [link to inventory record]

Substantially relevant: Example – Nanoparticles for efficient delivery to solid tumors (NIH, Est funding $333,084 over 3 years).  [link to inventory record]

Some relevance: Example – Nanoscale Science & Engineering Center for Integrated Nanopatterning and Detection Technologies (NSF, Est. funding $12,702,550 over 6 years).  [link to inventory record]

Marginal relevance: Example – National High Magnetic Field Laboratory (NSF, Est. funding $171,883,246 [not a misprint] over an estimated 6 years).  [link to inventory record]

I would be the first to agree that research in the areas of drug development and metrology—which account for many of the projects in the “substantial” and “some” categories—may be very beneficial to addressing risks.  But in the short term, this is not research that is going to answer the questions on the top of most people’s “urgent” list.  To pretend otherwise is like going to the doctor with a headache, and being told that there are millions of dollars being invested on research on cancer drugs that might also offer insight into the underlying mechanisms for head pains—when all you wanted was an aspirin!  

Fortunately, Europe seems to be a little more on the ball—in terms of honest reporting at least!  Risk research listed in the recent document “EU nanotechnology R&D in the field of health and environmental impact of nanoparticles” [PDF, 400 KB] lists projects that are almost all highly relevant to addressing risk (in my assessment at least).  And crunching the figures, you arrive at a European-wide investment in highly relevant nanotechnology risk research for 2006 of around $24 million—not far off twice the U.S. investment.  

These figures are also in the PEN inventory—for anyone to see and verify. 

The NNI’s $68 million may be a feel-good figure; it may be an attempt at international one-upmanship; or it may just reflect a naïve understanding of how to assess the true relevance and value of risk research.  Whatever the explanation, it does little to enable a true assessment of what still needs to be done to find answers to critical questions.

In terms of bean-counting to justify past performance or inform future actions, I have to conclude the NNI is guilty of the former.  The last sentence in the NNI quote above seems to confirm this: 

“In short, the analysis demonstrated that the Federal Government is supporting more EHS research than has been previously identified, and the research is well-distributed across key priority areas.”  

The PEN assessment provides in my opinion a much more honest perspective on what is and is not going on, that has the potential to inform future research strategies.  The good news is that it is also the basis for the OECD Working Party on Manufactured Nanomaterials international database on environment, health and safety research [further details here].  Hopefully the release of this database in June of this year will bring some much-needed transparency and accountability to what has so far been a less than transparent process.

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This post first appeared on the SAFENANO blog in April 2008

The small American town of Sunnyville is a town in crisis.  Against a backdrop of job losses that have decimated the local community, citizens are struggling to decide whether to welcome two major nanotech-enabled industries into the town, or whether to reject them because the new technology might create more problems than it solves.

As if this wasn’t enough, it has just come to light that local company “Happy Home Paint” has been contaminating a neighborhood beauty spot with toxic chemicals for years, and the only way of cleaning the area without destroying it is by using a developmental nanoparticle-based technology.

Will nanotechnology revitalize this town, or will it end up being the straw that breaks the camel’s back?  The locals are having a tough time deciding.

The scenario is fictitious (you might have guessed), but the issues echo real-life hopes and concerns over nanotechnology.  Sunnyville stars in “Nanotechnology: Power of Small”—a major new TV series exploring the complex interplay between nanotechnology and society.* I had the dubious pleasure of participating in the third program of the series, addressing environmental issues.

Each program in “Power of Small” uses hypothetical scenarios to push an unprepared and unscripted panel of “experts” to address complex issues.  Imagine on-the-fly role-playing in front of a live audience while you are being filmed for later humiliation, and you begin to get the idea.

Actually—and to my surprise—the end result is an entertaining and rather sophisticated assessment of complex issues, where there are no clear right and wrong answers.  I was one of twelve on a panel working through decisions facing the fictional town of Sunnyville.  With me were leading experts from the worlds of science, law industry, journalism, government and environmental advocacy; all grappling with a plethora of tough issues under the guiding hand of moderator John Hockenberry.

In the course of filming we considered the merits of allowing the nanotech company “Solar Synergies” to build a nano solar panel plant in the town; worried over the covert use of nanotechnology by the food producer “Admiral Chicken” to make better tasting, longer-lasting products; and agonized over the use of nanotech to clean up after local polluter “Happy Home Paint.”  As you can imagine, the discussions were spirited at times!

While it could be argued that the first major American TV series addressing nanotechnology might have been better focusing on science, “Power of Small” achieves something rather important—it eloquently demonstrates the need for broad engagement throughout society, if complex decisions on emerging nanotechnologies are to be made.

In each of the programs (dealing respectively with surveillance and privacy, health, and the environment), the issues raised have no clear-cut answers.  And as a result, the decision-making process rests on the shoulders of people who stand to gain or loose by the technology.

Of course, if a diverse bunch of people are going to be involved in deciding the course of nanotechnology, it’s preferable that they know at least something of the science—so maybe it is time for some glossy big-budget nanotech science programming, now “Power of Small” has shown us how tough the societal debates are going to be.

(And just for the record; daunting though the process was, the pleasure of participating in “Power of Small” and seeing such a polished final product was far from “dubious”!)

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*“Power of Small” premiers at an event hosted by the Project on Emerging Nanotechnologies and the National Science Foundation in Washington DC, on 2nd April 2008.  The series of three programs is also viewable on the internet at www.powerofsmall.com.

“Power of Small” is part of the Fred Friendly Seminars series of programs.

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This post first appeared on the SAFENANO blog in March 2008

What determines your view of nanotechnology—the message, or the messenger?  Most of us would like to think it is the message that governs our internal risk-benefit analysis.  But research published this week suggests other factors may be at work.

Dan Kahan at Yale Law School and his colleagues are shaking up our ideas on effective communication and engagement when it comes to complex issues like emerging nanotechnologies.  They have already demonstrated what many jaded science communicators have learned the hard way—that shouting louder and longer about the facts doesn’t necessarily lead to “right-minded” thinking in the general population.*  In their latest study (available here) they show that when it comes to balancing possible nanotechnology benefits and risks, the messenger is quite possibly as important as the message.

In brief, the team assigned positions on nanotechnology risks and benefits to four fictitious cultural advocates and recorded the risk perceptions of 800 people, based on which advocate was giving which message.  In technical terms, both subjects and advocates were broken down by their different worldviews: hierarchs versus egalitarians, and individualists versus communitarians (mystified by the terminology?  You’re not alone!).  In practice, this led to four visually distinct advocates:

• the smooth “leader of industry”—complete with power-suit (individualist/hierarchist);
• the paternal community leader—sporting jacket and tie (communitarian/hierarchist);
• the slick young entrepreneur—sans tie (individualist/egalitarian); and
• the bearded Prof.—also without a tie (communitarian/egalitarian).

(My descriptions by the way – not Dan’s.)

The results: when subjects with egalitarian tendencies were exposed to an advocate who looked like a fellow egalitarian calling for a suspension of nanotechnology development, their perception of the risks went up.  And when hierarchs heard someone who looked like another hierarch advocating nanotechnology development, their perception of the risks went down. In other words, the perceived values of the messengers were strongly biasing the subjects’ perceptions of risk.  According to Kahan:

“when individuals of diverse cultural outlooks observe an advocate whose values they share advancing an argument they are predisposed to accept, and an advocate whose values they reject advancing an argument they are predisposed to resist, cultural polarization grows.”

The fun really started when the fictitious thought-leaders were given the opposite message to what you might expect—the “leader of industry” calling for a suspension of nanotechnology and the Prof. advocating its development.  People tended to follow the advocates, even though the views being expressed were out of sync with their worldview! Kahan again:

“if, however, individuals observe an advocate whose values they share advancing the argument they are otherwise predisposed to resist, and an advocate whose values they reject advancing the argument they are otherwise predisposed to accept, there is a complete inversion of the positions on nanotechnology risks normally associated with particular cultural outlooks.”

This limited message-mixing exercise gives a tantalizing taste of what a planned follow-on study might reveal. But even accounting for its somewhat narrow scope, the conclusion is inescapable: the messenger is important.

Even more intriguing to me (or worrying – depending where you lie on the egalitarian/hierarchist/whatchamacalit/thingummybob scale) is that people may be willing to follow the opinions of advocates based on what they look like. (okay, so it is a little more complex than that, but what is clear is that visual impressions of empathy count—possibly more so than the science).

So where does this leave us with nanotechnology?  For a start, in case we hadn’t quite got the message yet; the science does not speak for itself.  If we are to communicate nanoscience and nanotechnology effectively and engender a meaningful dialogue amongst citizens and other stakeholders, we need to think carefully about who the messengers are, and what messages they convey.

The cynic in me finds this rather worrying—are we opening the doors to manipulating public opinion here, simply by choosing advocates that look the part? (To be honest, when first reading through this study the cynic in me also thought “so what’s new—haven’t we always suspected that in today’s society image is everything?”).

But Kahan eloquently makes the point that if we want enlightened public deliberation on nanotechnology, we have a means to neutralize cultural bias. The study shows that when multiple messages come from advocates having different outlooks—what Kahan calls “advocacy pluralism”—cultural bias begins to disappear.  And this opens up the pathway to dialogues that are less likely to divide along cultural lines.

This surely is where we want to be, if the long-term aim is to enable science-based decision-making.  But getting there will require action on the part of governments and others: to identify and equip suitable messengers; and to develop understandable and level-headed messages.  And this must be followed by genuine citizen engagement, if the door to science and technology decision-making is to be opened wider to allow the public in.  Only then will we be able to work effectively in partnership towards nanotechnologies that deliver on their promise.

And for those readers who are currently holding judgement on this piece until they know what I am wearing; let’s just say that in the complex world of cultural advocacy power-dressing, I strongly believe that less is more.

* Kahan, D., Slovic, P., Braman, D., Gastil, J. and Cohen, G. (2007). Nanotechnology risk perceptions: The influence of affect and values, Wilson Center Project on Emerging Nanotechnologies, Washington DC.

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This post first appeared on the SAFENANO blog in February 2008

Labeling – is there anything more contentious in the safe nanotech debate?  Some are fearful that too much knowledge will confuse and worry muddle-headed consumers.  Others can only see the marketing opportunities of a “nano-inside” label. Then you have the nano-doomsday merchants, who seemingly would like nothing better than to slap a bright yellow nano-hazard sticker on all things small.

And of course, we cannot forget those “magic” nano products – not the surface treatment that allegedly messed people’s lungs up (which was neither magic, nor nano) – but those items which miraculously change from “nano-enabled” to “nano-no-more” at the wave of a marketing executive’s wand.

Into this fray comes the British standards body, BSI.  Published this week as part of the BSI “nano-nine” , the document “Guidance on the labelling of manufactured nanoparticles and products containing manufactured nanoparticles” does just what the title claims.

In a bold attempt to put the issue of nano-labelling on a rational footing, the stated purpose of PAS130 (to use its more succinct title) is:

• to promote a standardized approach to labelling;
• to ensure that users of MNPs [manufactured nanoparticles] and PCMNPs [products containing manufactured nanoparticles] can correctly identify the MNP contents for the purposes of making informed decisions in selection, purchase, distribution, handling, use and disposal;
• to inform regulatory authorities and assist healthcare professionals, technicians, health and safety officers and others to make informed decisions in relation to matters of occupational, consumer, public and environmental health and safety;
• to standardize the use of the term “nano” in labels;
• to provide guidance on the use of other specific terms in these labels.

What a sensible idea!  Even more impressive is the list of organizations that have contributed to the document—everyone from the Soil Association (of recent “no-nano in organic produce” fame) to the Nanotechnology Industries Association to the Cosmetic Toiletry and Perfumery Association – strange bedfellows indeed for such a potentially divisive topic.  One might be forgiven for fearing an outbreak of reasonable thinking in old Britannia!

This is actually a very useful guide.  It systematically addresses the multiple purposes of labels, and provides sound recommendations on how to go about developing and using them.

In part, the debate over labelling has been polarized because people have been talking at cross purposes.  At times discussions have taken on the surreal feel of a movement to ban cats because they bark: misguided and rather badly informed!

Labels can and do serve multiple purposes. The trick is to work out what type of labelling is being discussed, and how it might help users, industry and regulators make informed and effective decisions on different nanotechnologies.

The BSI document does an admirable job of untangling the confusion, and stating clearly and concisely the purposes of labelling; what the limitations are, and how nano-specific labels might be used effectively in different circumstances.  I’m sure it will not be the last word on the issue, but at least it sets the scene for making real progress.

It’s not as much fun as the ETC Group’s bright yellow nano-hazard labels, but it’s probably a tad more useful

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This post first appeared on the SAFENANO blog in February 2008

The popular computer game “SimLife” allows users to create and manipulate virtual people.  But what are the chances of us one day being able to do the same with real organisms: building new life-forms out of basic chemicals, so “SimLife” becomes “SynLife”?

This week’s announcement by J. Craig Venter’s team (and the associated paper in Science) that they have successfully synthesized the complete genome of the bacterium Mycoplasma genitalium is an important step towards achieving what is becoming known as “synthetic biology”.  By constructing complete DNA sequences from scratch, the door is being opened to transforming common laboratory chemicals into new living organisms; that are engineered with specific purposes in mind.  And perhaps not surprisingly, this manipulation of DNA at the nanoscale is increasingly being seen as part of the “nanotechnology revolution”.

But is synthetic biology really nanotechnology?

I was initially sceptical. While synthetic biology holds the promise of being a truly transformative technology, I suspected it was in reality just advanced biochemistry; and calling it “nanotechnology” was little more than a cynical ploy to jump on the nanotech bandwagon.  Yet I must confess, having discussed the question with researchers in the field, my initial impressions are shifting.

If you consider nanotechnology to be the intentional manipulation of matter at the nanoscale and the exploitation of resulting material properties, then synthetic biology certainly begins to sound like nanotech.  In contrast to “natural” biology, synthetic biology aims to construct with intent the DNA code of brand new life forms, which will quite literally have functionality that has been engineered-in at a nanometer scale.  And the long-term vision of synthetic biology is to create DNA sequences that will lead to new proteins, precisely engineered to undertake specific tasks.

If this is not nanotechnology, I don’t know what is.

But I have to wonder: is the issue of whether synthetic biology is nanotechnology or not really the right question?  Surely the challenge of synthetic biology is not what label we give it, but whether we have the maturity to use our new-found abilities to change the world for the better, without creating more problems than we solve.

Conceptually, there is remarkably little difference between the sequence of base-pairs in DNA and the ones and zeros making up a computer program.  But while the latter allows software engineers to create incredibly complex worlds inside computers, DNA engineering opens the door to re-programming life itself.  Imagine at some point in the future creating microbes to harvest energy, sequester carbon dioxide and clean up pollution, simply by typing their desired characteristics into your “SynLife” program and pressing “Enter.”  It sounds fanciful, but while the consequences are profound, the technology is almost within our grasp.

I don’t think it is hyperbole to say that synthetic biology has the potential to transform our world.  I would probably go so far as to say that it holds at least some of the keys to overcoming some of the biggest challenges facing society—including climate change, poverty and disease.  But the challenges to using this new technology responsibly are immense: How will we handle the temptation to misuse synthetic biology; what safeguards will be put in place to prevent unforeseen “bugs” in the system; and who will determine where the ethical line in the sand is drawn, which says “thus far – and no further” – or should there even be such a line?

Thrilling and challenging as the prospects of synthetic biology are, we are not quite there yet.  While Venter’s team have assembled the first complete synthetic bacterium genome, they have yet to see whether they can use it to create a living, replicating organism.  The next step is to place the DNA in a cell and, in Venter’s words, see whether the cell “boots up”.  But the team is hopeful that this will be achieved in a matter of months.

And when it is, the question will not be “is this nanotechnology?” but “are we ready for it?”  I hope we are.

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Footnote

While the term “synthetic biology” is widely used to describe the intentional manipulation of DNA to create new proteins and organisms, it is also used in another context: the creation of non DNA-based systems that mimic biology.

To purists, this is true synthetic biology: not playing around with the existing building blocks of life, but creating a brand new construction set.  This alternative construction set would consist of new molecules built from scratch, as well as systems of such molecules, that are designed to carry out functions analogous to their biological counterparts–transporting materials, harvesting energy, building structures, and even replicating themselves.

Given the current state of nanotechnology—sophisticated as it is—it is hard to imagine coming close to mimicking the complexity of even the simplest DNA-based systems in our lifetime.  Yet this is an active area of research, and at some point it will raise many of the questions currently emerging with Venter’s vision of synthetic biology.  But there is one important difference: while DNA-based synthetic biology tinkers with life as we know it, non-DNA synthetic biology raises the possibility of creating completely artificial life-forms.  And this—if it is even plausible—opens up a whole other can of worms!

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This post first appeared on the SAFENANO blog in February 2008

In July 2007, a specially convened task force of the United States Food and Drug Administration (FDA) concluded that size does in fact matter (FDA 2007).  The focus of the task force was not on the importance of “largeness”, but rather on the technology of the unimaginably small—nanotechnology.

Nanotechnology is the technology of manipulating matter at near-atomic levels; typically, but not exclusively, within the size range of 1 – 100 nanometers.  Working at this scale, it becomes possible to combine materials in ways and forms unimaginable more than a few decades ago.  Imagine the contrast between eighteenth century surgery and modern microsurgery, and you begin to get an idea of what this emerging technology offers.

According to the FDA task force, “properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated products might change repeatedly as size enters into or varies within the nanoscale range”. But as Professor James Moor and Professor John Wecker point out in the Spring 2007 edition of Medical Ethics [PDF, 805 KB], nanotechnology not only raises safety and regulatory issues, but ethical questions as well (Moor and Wecker 2007).

At the heart of the buzz surrounding nanotechnology is its potential to extend what can be achieved with conventional technologies, and the tantalizing possibility of developing radical new technologies.  Nanotechnology is not so much a specific technology as a new way of doing things, or a new technological tool kit.  In the words of Moor and Wecker, “[n]anotechnology offers us the general capability of material malleability”.

The idea of engineering at the nanoscale conjures up images of everyday mechanical objects shrunk to the scale of molecules; nano-gears, nano-engines, even nano-machines—conventional engineering, but at a miniscule scale.  Such nano-engineering would enable us to build complex devices from handfuls of atoms, increasing the performance and utility of human-scale products.  It would also help use limited resources expediently—making products molecule by molecule, with minimal waste.  In other words, this is a vision of nanotechnology that would emulate the biological world and lead to a synthetic biology; augmenting existing natural nano-machines and “molecular assemblers” that have evolved over billions of years, with an inorganic counterpart over which we have full control.

Eric Drexler envisaged such a world in his book Engines of Creation: The Coming Era of Nanotechnology (Drexler 1986).  Yet, while some of these concepts may one day become a reality, the nanotechnology of today looks very different.  Returning to the idea of engineering at the nanoscale, the chemist and Nobel Laureate Richard Smalley is credited with describing nanotechnology as “the art and science of building stuff that does stuff at the nanometer scale”.  Scientists and technologists alike are drawn to nanotechnology because of the unconventional behavior exhibited by many nanoscale materials, and their ability to “do stuff” in ways conventional materials do not.  As atoms and molecules are formed into nanoscale structures, intrinsic material properties like conductivity, transparency and chemical reactivity diverge from those observed in the constituent molecules or the bulk material.

But engineered nanomaterials can also demonstrate unconventional behavior that is associated with extrinsic attributes like size and shape. For instance, engineering a material as discrete nanometer-diameter particles might make it easier to incorporate into products, deliver to specific areas of use, or substantially increase the surface area to mass ratio.  In these cases, the intrinsic physical and chemical properties of the engineered nanomaterial are not necessarily scale-specific, but the ways in which the material is used are.

The scale-specific behavior of engineered nanomaterials takes on a special significance in interactions with biological systems and processes. Biology is inherently nanoscale, and purposely-engineered nanoscale materials allow the possibility of modulating biological processes at a fundamental level. Nano-bio interactions may result from scale-specific physical and chemical properties intrinsic to some nanoscale materials.  But they may just as likely result from nanoscale materials having access to biological processes that are inaccessible to larger scale materials.

In this way, nanotechnology provides a high-precision tool kit for exploring and influencing living systems.  The biological utility of nanotechnology is demonstrated effectively through its use in potential cancer treatments. Researchers at Rice University for example are combining the scale-dependent photonic properties of nanometer-thick gold shells, with the size-dependent biological properties of nanoscale particles, to create composite particles capable of preferentially treating tumors.  Gold-coated nanometer-diameter silica particles are introduced into the bloodstream, from where they preferentially pass through the leaky vasculature around tumors.  Once sufficient material has accumulated around the diseased cells, irradiating the particles with a laser tuned to the gold nanoshells causes localized heating, destroying the growth while leaving healthy tissue unharmed (O’Neal, Hirsch et al. 2004).

Going a step further, researchers at the University of Michigan are developing multifunctional nanoparticles for treating specific cancers.  Starting with generic nanoparticles, various functional components are added: ligands that attach to specific biological targets; contrast agents to allow particles to be tracked round the body; and sensitizing agents, enabling particles to receive and respond to external signals.  With these components, nanoparticles are being developed that selectively target and destroy cancer cells, while minimally impacting the rest of the body (Koo, Fan et al. 2007).

From relatively simple nanotechnology applications to the possibilities of synthetic life, nanotechnology provides us with tools for developing radical new processes and products.  And with these tools come the social and ethical responsibilities to use them wisely.  Concerns have already been expressed over potential new risks to humans and the environment that nanoscale-specific material behavior present. Little is known about how nanomaterials released into the environment will be transported, transformed and accumulated, or their impact on sensitive ecosystems (Oberdörster, Oberdörster et al. 2005).  Animal studies have demonstrated that nanoscale particles can enter and be transported within bodies in ways that larger particles cannot, and research suggests some nanomaterials are more potent in organs such as the lungs than their larger scale counterparts (Oberdörster, Stone et al. 2007). There are also early indications that nanoscale materials might interfere with protein conformation, and even lead to enhanced fibrillation rates in proteins associated with amyloid diseases such as Parkinsons and Alzheimers (Linse, Cabaleiro-Lago et al. 2007).

Studies remain inconclusive as to what might make nanomaterials harmful and what can be done to avoid harm.  Recommendations have been made for better-focused and funded strategic research (e.g. Maynard, Aitken et al. 2006).  But the responsible use of nanotechnologies will depend on more than good risk management.  In their article, Moor and Wecker suggest that nanotechnology has the potential to raise one of the ultimate ethical and medical issues: therapy versus enhancement.  At what point do we cross the line between restorative biocompatible materials and implanted sensors (for instance), and the enhancements such technologies will offer to healthy individuals?

Already, there is serious discussion on how nanotechnologies might extend a person’s lifespan, or even be used to enhance an individual’s intelligence (Roco and Bainbridge 2003). But the ethical issues raised by nanotechnology go further:  Who will receive the benefits of these new technologies, and who will pay the price?  Will nanotechnologies widen social, economic and cultural divides, or close them?   What are the implications of research into emulating biological systems?  And what are the consequences of not grasping the opportunities being offered by nanotechnology?

Many of these issues are not unique to nanotechnology, but as Moor and Wecker intimate, the possibilities that nanotechnologies offer to do things differently throw them into sharp relief.  Nanotechnology has the potential to improve living standards around the world, and offers solutions to some of the most pressing challenges we face: renewable energy, plentiful supplies of clean water, effective treatments for cancer, to name just three.  If our aim is to improve quality of life and do good, it would be irresponsible and even unethical to deny the world what nanotechnology has to offer.  Yet this potential for good must be weighed against the very real possibilities of causing harm, widening equity imbalances and reducing autonomy.  A future without nanotechnology would be a poorer, harsher place.  But a world where nanotechnology is not developed within a clear ethical and social framework could be immeasurably worse.  Either way, we have a challenge on our hands to move forward responsibly.  When it comes to navigating through the implications of emerging technologies on our lives, size, it would seem, really does matter.

Drexler, E. (1986). Engines of creation: The coming era of nanotechnology. New York, Anchor Books.
FDA (2007). Nanotechnology.  A report of the U.S. Food and Drug Administration Nanotechnology Task Force. Washington DC, Food and Drug Administration.
Koo, Y. E. L., W. Fan, et al. (2007). “Photonic explorers based on multifunctional nanoplatforms for biosensing and photodynamic therapy.” Applied Optics 46(10): 1924-1930.
Linse, S., C. Cabaleiro-Lago, et al. (2007). “Nucleation of protein fibrillation by nanoparticles.” Proc. Natl. Acad. Sci. U. S. A. doi:10.1073/pnas.0701250104.
Maynard, A. D., R. J. Aitken, et al. (2006). “Safe handling of nanotechnology.” Nature 444(16): 267-269.
Moor, J. H. and J. Wecker (2007). “Nanotechnology and nanoethics.” Medical Ethics 14(2): 1-2.
O’Neal, D. P., L. R. Hirsch, et al. (2004). “Photo-thermal tumor ablation in mice using near infrared-absorbing nanoparticles.” Cancer Letters 209(2): 171-176.
Oberdörster, G., E. Oberdörster, et al. (2005). “Nanotoxicology: An emerging discipline evolving from studies of ultrafine particles.” Environ. Health Perspect. 13 (117): 823-840.
Oberdörster, G., V. Stone, et al. (2007). “Toxicology of nanoparticles: A historical perspective.” Nanotoxicology 1(1): 2 – 25.
Roco, M. C. and W. S. Bainbridge, Eds. (2003). Converging technologies for improving human performance.  Nanotechnol;ogy, biotechnology, information technology and cognitive science. Norwell MA, USA, Kluwer Academic Publishers.
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First published in the Lahey Clinic Medical Ethics Journal, Fall 2007 [PDF, 215 KB]