Update 1/6/11: The comment period has been extended to January 21

There are only two days left to comment on the current draft US National Nanotechnology Initiative Environmental, Health and Safety strategy (the comment period closes January 6) – so time to read the draft, log in to the portal and add your comments.

This is actually a rather important opportunity for anyone with an interest in the development of safe and successful nanotechnology-based applications to the US government in developing and implementing a strong safety research strategy.

I finished reviewing the draft strategy this afternoon and submitted my thoughts – admittedly over five comments, given the just-slightly frustrating cap on 4000 characters per comment.  Just so that all the words appear in one place at least somewhere, I’ve included a copy of my comments below.

I must confess I tried to be positive in my comments – despite suggesting (a little naughtily) that trashing 75% of the report might make it better!  Admittedly there were plenty of things here that worried me – failing to ground an analysis on what needs to be done on what has already been achieved; a sorry excuse for a chapter on risk assessment and management; and a reliance on project numbers and $$ as indicators of whether research needs are being adequately addressed, to name just a few.  But there was also a ray of sunshine at the end of the report – a chapter that holds the seeds of a coordinated approach to nanotech risk research that could well work – even within the limitations of an inter agency initiative with no budget and no authority.  As I note below, this could form the core of an effective cross-agency strategy that focuses more on a framework for enabling targeted and responsive research, rather than the research itself.

Oh, and I was also pleased to see that, in response to criticisms from the National Research Council after the previous strategy, there is now an in-your-face mission statement – just so no-one misses it this time round.

The NNI strategy portal can be accessed here – comments on the EHS strategy need to be submitted by close of business (presumably) on January 6.

Review of the National Nanotechnology Initiative 2011 Environmental, Health and Safety Strategy

Andrew Maynard

Director, University of Michigan Risk Science Center

Submitted Jan 4 2011

The close of 2010 marked the tenth anniversary of the US National Nanotechnology Initiative (NNI).  Over the NNI’s first decade, the potential health and environmental impacts of the products of nanotechnology – engineered nanomaterials in particular – have moved from being of relatively minor concern to having a significant supporting role in the US federal government’s nanotechnology strategy.  Reflecting this, the federal government – under the auspices of the Nanotechnology Environmental and Health Implications working group (NEHI) – has published a series of documents and strategies aimed at coordinating, focusing and stimulating agency research addressing the safety of engineered nanomaterials.  On December 6 2010, the NEHI invited comments on the latest in this series of documents – the draft National Nanotechnology Initiative 2011 Environmental, Health and Safety Strategy.  The following comments respond to this request.

In developing a cross-agency research strategy, the NNI is in something of a difficult position.  Neither the NNI, NSET (the National Science and Technology Council Committee on Technology Subcommittee on Nanoscale Science, Engineering and Technology) or the NEHI have budgetary, policy or operations authority over the federal agencies they represent.  So developing and implementing a research strategy that is both actionable and accountable is a tough challenge.  At the same time, urgent, coordinated, responsive and substantive action is needed across federal agencies according to the NEHI and other organizations, if the safe development and use of engineered nanomaterials is to be ensured.  This begs the question: how can the NEHI respond to this urgent need, without the conventional tools of resources and authority that usually back up a strategy?  Or to be more specific, does the current draft environmental, health and safety strategy manage to “pull it off”?

Having read the draft carefully, I think the answer is no.  But, there are some rather bright glimmers of hope here.  In reviewing the draft document, my first instinct was to conduct a line-by-line evaluation of the content – what is missing, what is redundant, what doesn’t make sense, what could be expressed better, and what could be developed further.  But this would have missed the central question of whether the strategy enables what needs to be done to be done, and if it doesn’t, how could it be different – within the constraints of a cross-agency document?  This therefore is where the bulk of my comments focus.

To start with, it’s worth asking what the federal government hopes to achieve here?  I’m pleased to say that the mission is clear in the draft  – protect public health and the environment, use science-based risk analysis and management approaches, and foster technological advances that benefit society.  This is where the government is going – a nanotechnology-enabled future where people are healthy, and risk-based decision-making is informed by science.  With this established, the next logical question is how are they going to get there – which also prompts the supporting question of where are they now?

This is where the draft strategy gets a little shaky.

The question of where the federal government – and the field of nanomaterial safety – is now – is addressed in a somewhat lateral and obscure way within the draft document.  Research needs are based in part on recommendations from a series of stakeholder workshops that presumably reflected the state of the science – but in almost all cases they are presented as a given, with little or no justification or rationale.  This demands a great deal of trust from the reader – especially as the draft strategy is rather sparse on citations that support the statements being made.  But more importantly, the document provides no indication of the extent to which progress has already been made towards each research need to date – both within and beyond the confines of the federal government – and what still needs to be done to achieve the strategy’s stated mission. What we are left with is a one-sided list of research areas that – while important – are presented with very little context.  What context there is tends to focus on the number and cost of federally-funded research projects in specific areas.  On occasion this is useful information – especially where there is no research being funded in a particular area – but I struggled to understand how these numbers indicated research and information gaps than need to be filled if concrete progress is to be made towards the draft strategy’s stated mission.

On the issue of how the federal government intends getting to where it wants to be, the draft is something of a mixed bag.  Chapters 1 – 6 – which form the bulk of the document – provide next to no insight into how the NEHI and its respective agencies intend to address the research and information gaps that are identified.  Chapter 7 is different.  Addressing the need for new actions and initiatives on working with data (informatics and modeling), it is still more focused on needs than solutions.  But it does provide a number of clear challenges to agencies on how they work with data if they are to make progress.  And as an aside, it also presents some of the more innovative and interesting ideas to appear in the document.

However, it is chapter 8 – The Path Forward – where the draft document becomes particularly interesting.

In chapter 8, there is a move toward developing an approach that will help nudge federal agencies towards where the NEHI feel they should be, that begins to get around the limitations inherent in a cross-agency group. This comes in two parts – a set of principles that will help encourage agencies to move in the right direction, and a framework that supports the NEHI and the Nanotechnology Coordinating Office (NNCO) in implementing the strategy.

The principles addresses six areas: (in my words) prioritizing nanomaterials of interest; establishing systems for reproducible, reliable and translatable research; helping ensure high quality data; coupling research to different risk assessment needs; partnering with stakeholders and engaging with the international community.   These form the beginnings of a robust framework that sets the scene for ensuring relevant and responsive research is conducted, rather than dictating who does what.  It is a welcome move.  The six areas make sense, and are well articulated.  My only slight concern is that there is perhaps too strong an emphasis on standard measurements, terminology and nomenclature.  These are important – but it must always be acknowledged that they are a means to an end only, not an end in themselves, and that there are areas of research that can be stifled by an over-zealous application of standards.

The implementation and coordination framework that follows articulates eight areas where the NEHI and participating agencies can and are taking action together.  These include the extremely welcome appointment of a named Environment, Health and Safety coordinator within the NNCO, the exploitation of digital media and networking opportunities, and the facilitation of partnerships with industry.

Talking a high-level look at the draft strategy, if I was to suggest radical revisions, I would recommend ditching chapters 1 – 6, and developing chapter 8 as the core of the strategy.  This is somewhat drastic – and no doubt unfeasible. But augmented by the many other reports that exist in the public domain outlining (again and again) research needs addressing nanomaterial safety, this chapter holds the seed of an approach that enables federal agencies to work together to address a common set of goals in response to these needs.  And it is an approach that has the potential of working within the constraints of an interagency initiative.

But this still begs the question – would this be enough? Using such an approach, could the NEHI enable the federal government to make substantial progress in ensuring the safety of engineered nanomaterials and the products they are used in – to get to where they want to be?  As the document stands, I think the answer is still no.  But there is promise here.

So what would it take to craft a federal strategy that enabled agencies to work together more effectively in ensuring the safe use of nanomaterials?  I’m not sure that this is entirely possible – an internal strategy will always be constrained by the system in ways that an externally-crafted strategy isn’t.  But I do think that there are three areas in particular that could be built on here:

1. Principles. The idea of establishing principles to which agencies sign up to is a powerful one, and could be extended further.  For instance, they could include a commitment to working closely and cooperatively with other agencies, to working toward a common set of aims, and to critically reviewing progress towards these aims on a regular basis.
2. Accountability. The implementation and coordination framework set out in chapter 8 of the draft strategy contains a number of items that, with a bit of work, some group within the federal government could be held accountable to.  Formally, the NNCO would seem to be the most appropriate organization to be held responsible for progress here.  With accountability for actions that support the implementation and coordination of the strategy, a basis could be built for an actionable strategy, rather than wishful thinking.
3. Innovation. So often in documents like this, there is a sense of defeatism – “this is the system, and there’s nothing we can do to change it”.  Yet there are always innovative ways to circumvent institutional barriers in order to achieve specific ends.  I would strongly encourage the NEHI to start from the question “where to we want to go, and how are we going to get there”, rather than “what are we allowed to do”, and from this starting point explore innovative ways of making substantive and measurable progress towards the stated mission of the strategy.  Just one possibility here is to use the model of the Signature Initiatives being developed elsewhere within the NNI – which overcome institutional barriers to encourage agencies to focus on a common challenge.  Something similar to a Signature Initiative focused on predictive modeling, or personal exposure measurement, or nanomaterial characterization, could enable highly coordinated and integrated cross-agency programs that accelerate progress toward specific goals.  But this is just one possibility – there are surely many more ways of getting round the system!

In conclusion, the draft strategy is constrained by the challenges of working across federal agencies, contains a lot of information that doesn’t necessarily add tremendous value to addressing the stated mission, yet holds the seed of an effective strategy that could succeed within the constraints the NEHI is working under.