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.

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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)

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.

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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.

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…

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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…

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.

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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.

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.

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?

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

Policy, public perceptions, and the opportunities and challenges of synthetic biology

Synthetic biology—a supreme expression of scientific hubris, or the solution to all our problems?

Like everything in life, I suspect that the answer to the question is far from black and white.  Yet what is clear is that this emerging science and technology that merges evolutionary biology with systematic engineering raises many exciting new possibilities, together with a heap of complex social, ethical and even religious questions.

Striking the right balance between these opportunities and challenges will require people working together in new and innovative ways—especially those involved in researching, developing, using and overseeing synbio.  If the emerging technology is to reach its potential, some tough decisions are going to have to be made at some point on what is developed, how it is used, and how it is regulated.  And the more these decisions are based on sound science and informed thinking, the better.

This is the challenge a new initiative at the Woodrow Wilson International Center for Scholars has set its sights on.  The just-launched Project on Synthetic Biology aims to foster informed public and policy discourse concerning the advancement of the field, working in collaboration with researchers, governments, industries, non-government organizations and others.  Supported by a grant from the Alfred P. Sloan Foundation, the project will draw on experience gained in addressing science and technology policy issues by the Project on Emerging Technologies—so you can expect to see some familiar faces here ☺

Rather than write a tedious infomercial for the new project, I would suggest instead that you check out the snazzy new website at www.synbioproject.org.  Having said that, there are three things worth highlighting:

1.  Trends in American and European Press Coverage of Synthetic Biology.  Tracking the last five years of coverage.

The launch of the new project coincides with the publication of a new report on US and European Press coverage of synthetic biology, by Eleonore Pauwels and Ioan Ifirm.

The data-rich report notes that in the short term, public awareness and understanding of synthetic biology will be influenced by press coverage, and especially how the field is framed in the media.  In an area of growing press coverage on both sides of the Atlantic, the analysis shows small but relevant differences between American and European coverage.  The European press has typically focused more on addressing risks and benefits together, and highlighted benefits in the areas of health and energy.  In contrast, US coverage shows a bias towards covering benefits over risks and benefits combined, with an emphasis on energy and environmental applications.

The report authors recommend further assessing public perceptions to synthetic biology, promoting a transatlantic perspective on potential risks, and engaging citizens in the development of synbio.  Read the full report here.

2.  Synthetic Biology on the Nanofrontier?

This is a new audio podcast of a conversation between science reporter Karen Schmidt, and synthetic biology pioneer Jay Keasling.  Keasling is well known for his work on a new synthetic biology-based route to producing artemisinin—an anti-malarial drug—and  the use of a similar synthesis route to producing a new generation of biofuels.  This is a great podcast—perfect for the morning commute—and can be downloaded here.

3.  Your chance to win… small!

And finally, but definitely most importantly, the launch of the new project is being celebrated by a not-too-taxing quiz on synthetic biology.  Get the answers write (or keep on trying until you do), and you get the chance to win an iPod nano—perfect for listening to the Jay Keasling podcast on!  [Access the quiz here]

Synthetic biology is emerging at an interesting time for any new technology; where global challenges are crying out for new technological fixes, but hurdles to safe and successful development are constantly changing.  The new project aims to steer a path through this complex landscape, and help ensure synthetic biology is developed on sound science and informed decision-making.

So that rather than ending up with a bunch of synbio synners, we get the synthetic biology saints the world deserves.

(And I must apologize for such an ugly pun!  I blame overwork and not enough alcohol)

UPDATE, Dec 19:

The Alfred P Sloan Foundation has just announced a new $1.6 million synthetic biology initiative, that includes projects at the Hastings Center and the J. Craig Venter Institute, as well as the Wilson Center.

The new effort effort brings together leading scientists, ethicists and public policy specialists to explore the field’s potential benefits and risks, as well as ethical questions and regulatory issues.

From the release:

At the Hastings Center (http://www.thehastingscenter.org/), Foundation funding will allow for in-depth investigation into ethical issues that may arise in connection with developments in synthetic biology. The project aims to make serious contributions to scholarly literature, produce a base for further scholarship, and inform public policymaking.

Alfred P. Sloan Foundation funding will allow the J. Craig Venter Institute (http://www.jcvi.org/) to examine potential societal concerns associated with developments in synthetic genomics. The project will both inform the scientific community about these issues while also educating the policy and journalistic communities about the science. As a result, scientists, journalists and policymakers will be able to engage in informed discussions.

A grant to the Woodrow Wilson International Center for Scholars (http://www.wilsoncenter.org/) will analyze evolving public perceptions of potential societal risks that may arise related to research in and applications of synthetic biology, clarify whether our existing regulatory systems can address relevant risks that may be associated with the science, and inform and educate policymakers.

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Related posts:

Intrigued by synthetic biology?  These previous blog posts might be of interest:

Synthetic biology: Lessons from synthetic chemistry

Synthetic Biology 4.0—changing the way science is done

Small particles are sexy; Synthetic biologists are sexier!

Synthetic biology and the public: Time for a heart to heart?

Synthetic biology, ethics and the hacker culture

Synthetic biology and nanotechnology

“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 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

Are we so caught up in the thrill of nanotechnology, that we are blind to future pitfalls?  Are we having the new technology ride of our lives—with someone else’s future?  Are we living for the nanotech moment, and leaving the consequences to others to deal with?  In short, are we on a nanotechnology joyride?

The analogy doesn’t hold up that well to scrutiny.  But reading this week’s excellent article on nanotechnology in The Economist (A Little Risky Business, November 22) and Natasha Loder’s accompanying blog (The risks of nanotechnology, November 23), it struck me that we are still struggling to grapple with the potential consequences of our actions when it comes to nanotech.

In her blog, Loder writes

“While governments around the world have been falling over themselves to push money into nanotechnology research, they have been slower to fund and co-ordinate necessary work on risk assessment, nor to establish how they intend to apply existing regulatory frameworks to nanoparticles.”

For most people, the “thrill” of nanotechnology is its potential to make the world a better place—to create wealth and jobs, and revitalize economies; to improve the performance of products we use every day; and to solve difficult problems like treating cancer, getting clean water to people who need it, and generating clean, renewable energy.  Yet ironically, a lack of foresight on how to use emerging nanotechnologies wisely is in danger of preventing the very benefits we are hoping for.

Loder continues,

“Increasingly, [a lack of information on risks and regulation] is having an unsettling effect on nanotechnology companies. The large ones are doing (and can afford) the due diligence in safety research. The small ones are not doing the research, cannot afford it, and have little incentive to do so. Yet these are the companies that are out on the frontlines creating
very novel materials.”

The Economist makes the point that

“Firms must make sure that the goods they produce are safe for consumers, that their workers are healthy and that their factories and products do not cause damage to the environment. On the whole, that is the right approach in a market economy, but the uncertainties make it hopelessly over-optimistic for nanoparticulates”

Foresight requires relevant knowledge that comes from strategic research, yet even at this level, we seem to be struggling.  The Economist again:

“Earlier this year the Council for Science and Technology, which advises the British government, warned that progress on risk research into the toxicology, health and environmental effects of nanomaterials was far slower than promised. It said there was a “pressing need” for a
strategic programme of spending.

It is much the same story in America, where the co-ordination and planning of risk research is also taking years longer than anyone would have imagined. This has frustrated Brian Baird, the chairman of one of Congress’s science committees. On October 31st he told the government’s National Nanotechnology Initiative (NNI), that it was not acceptable that its EHS strategy, and its implementation plan, had not materialised some 18 months after it was due.”

Maybe “nanotechnology joyriding” is too strong an analogy, but it sometimes seems that we are in danger of driving into the nanotechnology future with our eyes wide shut.  I’m all for the “thrills” of a nanotech future, but would rather have the foresight to avoid the “spills”.  As The Economist points out “no-one wants to stifle the innovations and potential benefits that nanotechnology promises”.  To realize these benefits, perhaps it’s time we learned to be responsible drivers.

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This blog first appeared on the SAFENANO blog in November 2007

If you’ve ever wondered how to deal with the complexities of regulating a twenty first century technology like nanotechnology, wonder no more.  Last week, President Bush’s top advisors on science and the environment published a set of “principles for nanotechnology environment, health and safety oversight”.

Based on a multi-agency consensus-based process, the document outlines the principles that federal agencies “should follow … as they develop policies for environmental, health and safety oversight related to nanotechnology”.

And the overriding message? Don’t make things hard for industry.

Quoting the first lines of the first principle,

“Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic and environmental benefits…”.[1]

I was under the impression that environmental, health and safety oversight should be first and foremost aimed at preventing harm to people and damage to the environment.

Certainly, the regulatory process needs to account for multiple perspectives, including those of scientists, industry and citizens. Effective oversight will encourage innovation and sustainable advances in the long run—after all, harmful products are bad for business. And a framework for developing nanotechnology oversight can only serve to help coordinate efforts, and prevent regulation being unduly swayed by hype and speculation.

But to start a set of oversight principles with an admonition not to hold up nanotechnology development?  Mmm…
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[1] The full first principle in the document is:

“Purpose: Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.”

This post was first published on the SAFENANO blog in November 2007

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]