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.