In June 2005, the chairman and CEO of DuPont, together with the President of the Environmental Defense Fund, co-authored an op-ed in the Wall Street Journal titled “Let’s Get nanotech Right”. The piece called for broad multi-stakeholder collaborations to help identify and address potential health, safety and environmental issues arising from the development and commercialization of engineered nanomaterials. And it laid the groundwork for one of the more significant documents to be produced on working safely with nanomaterials over the past years – the Environmental Defense-DuPont Nano Risk Framework, published in June 2007.
Good as the Nano Risk Framework was, it didn’t escape criticism at the time – some thought it was too complex and onerous; others worried that it didn’t capture the needs and perspectives of the broader manufacturing community – especially small businesses and startups. So it’s no small deal that, nearly four years after the original framework was released, the International Standards Organization* has just published a Technical Report on nanomaterial risk evaluation that builds on the Nano Risk Framework.
ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework. Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document. But there have been some changes. Whereas the second step in the Nano Risk Framework described developing three “profile lifecycles”, the ISO document simply refers to “material profiles” and integrates the need for a lifecycle approach to these profiles within the text. The ISO report is written in a much tighter style than that of the original document, and looses some of the occasionally long-winded expositions on what should be done and why. And the ISO document is more compact – 66 pages as opposed to 104. But from a comparative reading, surprisingly little has been changed from the 2007 document.
The result is a clear, tightly focused and highly applicable and adaptable guide for developing strategies for evaluating and handling nanomaterials safely. It doesn’t come cheap unfortunately – it’ll cost you 158 Swiss Francs for a copy (tempting me to write facetiously about the cost of nano-safety these days) – but for anyone having to make pragmatic decisions on working as safely as possible with engineered nanomaterials, it’s CHF 158 well spent.
The Technical Report is built around a framework of six steps:
Describe materials and applications (establishing a clear sense of the materials being evaluated and their intended uses, including collecting information on analogous materials that might be useful).
Material profiles (profiling the material’s physical and chemical properties, its inherent environmental and health hazards, and its human and environmental exposure potential, across its complete life cycle).
Evaluate risks (estimating the nature and magnitude of risks, based on the profiles established in the previous step).
Assess risk management options (Developing a plan for managing the risks identified in the previous step).
Decide, document and act (Implement a course of action, based on the evaluation of risk and risk management options, that is relevant to each stage of the material or product’s development. This might include deciding to halt development of a product if the potential risks are deemed to outweigh the benefits, or the costs of reducing the risks to an acceptable level are prohibitive).
Review and adapt (regularly ensure that risk management systems established are working, and revise them as necessary in the light of new information).
Inherent to this framework is the need to make situation-specific decisions that are guided by the Technical Report but not necessarily prescribed by it, and the need to constantly review and revise procedures and decisions. This built-in flexibility and adaptability makes ISO/TR 31321 a powerful tool for developing tailored nanomaterial management strategies that are responsive to new information as it becomes available. It also presents an integrative approach to using materials safely, that deals with the need to make decisions under considerable uncertainty by blurring the line between risk assessment and risk management.
The report contains little in the way of background information, assuming that readers already know something about the challenges presented by using engineered nanomaterials safely. Instead, it provides clear and concise advice on what to consider and options on how to proceed at each stage of the framework. This includes providing lists of questions that help identify key pieces of useful information in evaluating and making decisions on potential risks, and the adoption of a no-nonsense writing style – the authors tell the reader what they need to know while avoiding inconsequential waffle.
All in all, this is an admirable document, removing much of the mystique of working safely with engineered nanomaterials, and providing a pragmatic and practical framework which can be applied everywhere from a research lab to a full scale production facility. It’s a shame that it isn’t free, as it also provides a common sense perspective on nanomaterial safety that I think would be valuable to anyone with an interest in the field – not just environment, health and safety professionals. But as a fall back there is still the original Environmental Defense Fund/DuPont framework, which after four years has lost surprisingly little of its edge.
*Update 5/27/2011 As some of you realized, there is no such organization as the “International Standards Organization” – it’s the International Organization for Standardization, or ISO (not an acronym). A silly error on my part brought on by writing on the plane and trying to get the blog out before my laptop battery died – and one I shouldn’t have made as I’ve done my time with ISO in the past! But I decided to keep the error in, as ironically, to many readers, “ISO” or “International Organization for Standardization” won’t mean as much to them as “International Standards Organization”.