The past few years has seen an explosion of interest in silver nanoparticles.  Along with a plethora of products using the particles to imbue antimicrobial properties on everything from socks to toothpaste, nanometer scale silver particles have been under intense scrutiny from researchers and policy makers concerned that they present an emerging health and environmental risk.  But a paper published last month in the journal ACS Nano suggests that, contrary to popular understanding, we’ve been exposed to silver nanoparticles for as long as we have been using the metal.

I became aware of work in Jim Hutchison’s lab at the University of Oregon some months ago that showed nanoscale silver particles are readily released from larger particles and pieces of metal.  I remember the shiver (quite literally) as I saw data that seemed to challenge the current obsession with nanoscale silver as a possible new and unusual risk to people and the environment.  And at the time I wondered just how people would react when they discovered how ubiquitous exposure to nano-silver has probably been for the past few thousand years.

But rather than headlines screaming “feds invest millions in researching a centuries old non-problem” when the work was published last month, the response was rather muted.  Since publication, there has been a piece in Chemical & Engineering News, a long article written by Gwyneth Shaw in the New Haven Independent, a bizarrely headlined article claiming “Nanoparticles ‘no threat to health’” in TG Daily (as if the inverted commas justify the clearly unfounded statement)… and that’s about it.  And I’m not quite sure what to make of this deafening indifference.

The research itself shows that under certain conditions, metallic silver will release large numbers of silver nanoparticles.  Researchers attached small silver particles to electron microscope grids and exposed them to moisture.  Over a period of weeks, the particles became surrounded by large numbers of much smaller particles – the silver was shedding silver nanoparticles (see images to the right).  Nanoparticle release was also seen when resting large silver objects on the grids.  And the effect wasn’t confined to silver – copper also released nanoparticles in the presence of moisture.  To be sure that this wasn’t a product of how the research was conducted, the researchers checked to make sure that the particles weren’t being produced because of conditions on the grid or in the electron microscope – they weren’t.

The implications of this work are quite stunning.  It implies – although verification is needed – that any object made out of silver or coated in silver will slowly release silver nanoparticles into the environment.  Silver jugs and cutlery – used since ancient times – will have been releasing silver nanoparticles into food and drink.  Silver jewelry will have been releasing silver nanoparticles onto wearer’s skin.  Silver tongue studs will have been releasing silver nanoparticles into people’s gastrointestinal tract.  As soon as you start to think about it, there are all sorts of places where people and the environment could have been coexisting with silver nanoparticles for some time!

Assuming that this is the case, what are the implications for current research on the health and environmental impacts of silver nanoparticles, of which there is rather a lot? (A search of the ICON nanoEHS Virtual Journal returns over 300 papers mentioning silver published since 2005).  Is nano silver a sufficiently unusual and potentially dangerous substance to justify millions of dollars being spent on researching its risks?  Does the new wave of nano silver products represent an emergent risk, or simply a repackaged old risk?  And if exposure to nano silver has been occurring for millennia, where is the evidence for harm associated with this exposure?

Of course, a critical factor here is how much stuff are people and the environment exposed to – how much nano silver will you be exposed to eating with premium silverware for instance, and how does this compare to wearing the latest offering of nano-silver socks?  It may be that the new interest in using nano silver in commercial products is leading to a significant jump in exposure.

Be that as it may, the most significant implication of the research to me is that it undermines the assumption that products carrying the “nanotechnology” label automatically present new and unusual risks.  Silver nanoparticles have been touted as a product of nanotechnology, and indeed they do fit the bill – intentionally engineered at the nanoscale to be used in unique ways.  And this association with nanotechnology has led to research and policy organizations to invest an awful lot of time and effort in them – from the Organization for Economic Cooperation and Development to the US Environmental protection Agency.  Yet from a health and environmental impact perspective, it is looking increasingly likely that many engineered silver nanoparticles are indistinguishable from those nanoparticles shed by every piece of silver and silver plated stuff in common use.

So where does this leave us?  Should we abandon research into the health and environmental impacts of silver nanoparticles?  Probably not, because we still need to understand the risks associated with what we intentionally use.  But we might want to ease back on the passion that seems to be driving interest in nano silver risks, almost to the exclusion of other materials.

And we might want to rethink framing nano silver as a new threat from an emerging technology – unless someone can convincingly demonstrate that the nanoparticles from my silver spoon are not as worrisome as those from my nano-engineered socks.

]]> http://2020science.org/2011/11/07/exposure-to-silver-nanoparticles-may-be-more-common-than-we-thought/feed/ 6 http://2020science.org/2011/10/20/new-us-federal-strategy-for-nanotechnology-safety-research-released/ http://2020science.org/2011/10/20/new-us-federal-strategy-for-nanotechnology-safety-research-released/#comments Thu, 20 Oct 2011 22:01:38 +0000 Andrew Maynard http://2020science.org/?p=4444

The latest iteration of the US National Nanotechnology Initiative’s Environmental, Health and Safety Research Strategy was released today – downloadable from nano.gov. A draft of the document has been on the streets since last December – this version was compiled after a public comment period on that draft that closed earlier this year (the key comments received are listed here).

Given the comments received, I was interested to see how much they had influenced the final strategy.  If you take the time to comment on a federal document, it’s always nice to know that someone has paid attention.  Unfortunately, it isn’t usual practice for the federal government to respond directly to public comments, so I had the arduous task of carrying out a side by side comparison of the draft, and today’s document.

As it turns out, there are extremely few differences between the draft and the final strategy, and even fewer of these alter the substance of the document.  Which means that, by on large, my assessment of the document at the beginning of the year still stands.

Perhaps the most significant changes were on chapter 6 – Risk Assessment and Risk Management Methods. The final strategy presents a substantially revised set of current research needs, that more accurately and appropriately (in my opinion) reflect the current state of knowledge and uncertainty (page 66).  This is accompanied by an updated analysis of current projects (page 73), and additional text on page 77 stating

“Risk communication should also be appropriately tailored to the targeted audience. As a result, different approaches may be used to communicate risk(s) by Federal and state agencies, academia, and industry stakeholders with the goal of fostering the development of an effective risk management framework.”

There is also an additional bullet in the section on Implementation and Coordination of the NNI EHS Research Strategy (page 94):

“Refocus NEHI. Through consultation with agency representatives, the leadership of the NEHI Working Group adapted its meeting format to ensure better coordination of research to achieve the goals of the NNI EHS Research Strategy. Four priority areas were identified: ongoing updates on agency nanoEHS activities; new opportunities for collaboration; research strategy implementation, coordination, and evaluation; and planning and outreach.”

But these are the most significant changes I could find.

Below, I’ve listed the key changes I came across reading through the document.  I’ve also looked at how some of the most specific public comments received – from Günter Oberdörster – have been addressed, as an indicator of how seriously the NNI took the comments received.

Looking at these differences – and where Günter’s comments have and have not been responded to – I can’t but help conclude that minimal attention was paid to the public comments. Even where very specific page and line comments were made, only the most trivial to respond to have been addressed.

This doesn’t worry me too much – for a federal document, the strategy isn’t bad, and certainly has the potential to help focus nanotechnology safety research efforts.  But I do wonder whether the federal government needs to get its public engagement act together, and either not bother with public consultation if it is simply a box-checking exercise, or have the courtesy of responding to comments – even if they aren’t acted on – if they do take them seriously.

_________________________________________

Specific significant changes between the draft and final strategies. 

I have probably missed some – but these are the ones that jumped out at me.

Vision

There was a subtle change in wording here:

Draft version: “In support of the National Nanotechnology Initiative (NNI), the vision for environmental, health, and safety research in nanotechnology is a future in which nanotechnology provides maximum benefit to human social and economic well-being and to the environment.”

Final version: “In support of the National Nanotechnology Initiative (NNI), the vision for environmental, health, and safety research in nanotechnology is a future in which nanotechnology provides maximum benefit to the environment and to human social and economic well-being.”

1. Introduction to the 2011 NNI Environmental, Health, and Safety Research Strategy

Page 1: Revised text: “… ensuring a clean water supply and remediating soil contamination.” instead of “… ensuring a clean water supply and soil remediation.”

Page 2:  New text added: “Overall priority is given to the EHS research that decreases the uncertainty in assessing and managing risk and that addresses the EHS objectives in the NNI 2011 Strategic Plan.”

Page 2: New text added: “Research and development remain essential to the fundamental understanding and development of tools and materials for nanotechnology. Fundamental research, development of infrastructure, and education will continue to contribute to the knowledge needed for Federal nanoEHS research.”

Pages 3 & 4: Figs 1-2: Figures, and the accompanying text, have been clarified.

Page 5: The figure to fig. 1-3 emphasizes the importance of research management framework underpinning the strategy.

Page 7: New text added: “A draft version was posted at strategy.nano.gov for public comment (Dec. 1, 2010-Jan. 21, 2011). Where appropriate, this strategy was updated in response to comments and new information.”

2. Nanomaterial Measurement Infrastructure

Page 16 of draft report: Deleted text: “Finally, NIST has requested funding in the FY2011 NNI Supplement to the President’s Budget to develop measurement methodologies and models for dynamic physico-chemical properties (e.g., transformations) of key nanomaterials; this funding would greatly accelerate research to address research need #3.”

Page 21: There is a stronger emphasis compared to the original text on the need for more research “More effort is needed for all research in this revised category: research need #5 is a newly defined research need, so no relevant projects were reported in the FY 2009 data call. However, there is work underway at NIST and at the Consumer Product Safety Commission (CPSC) to evaluate ENM release mechanisms from NEPs due to incineration, mechanical degradation, and consumer interactions.”

3. Human Exposure Assessment

Page 24: New text:  “These challenges also make international harmonization of exposure assessment methodologies and international collaboration in conducting health surveillance studies critically important.”

Page 25: Updated text: “Develop quantitative assessment methods appropriate for target population groups and conduct assessments of those population groups most likely to be exposed to engineered nanomaterials”

Page 26: New text: “Development of health surveillance projects with international partners would leverage funding and study populations, thus accelerating our understanding of human exposures and potential adverse health effects.”

Page 28: New text: “and (3) development and international harmoniza-tion of exposure assessment methodologies appropriate for epidemiological studies, studies of the effectiveness of control technologies, and other research areas.”

4. Human Health

Page 36: A new research need added: “ Evaluate the degree to which an in vitro response correlates with an in vivo response”

Page 43: Research need #3 transposed with research need #4, compared to the draft report.

5. Environment

Page 43 of the draft report: Deleted text:  “and to instilling public confidence in the safety of nanomaterials and nano-enabled products that could benefit society.”

Page 58: Clarification that “An additional 9 projects include environmental transport components and are included under “Multiple Research Needs.””

Page 59: New text added “They may also bind to other contaminants in the environment.”

Page 50 of the draft report: Deleted text: “In other words, nanoscale may not be a characteristic that supports assumptions about potential toxicity for all nanomaterials.”

6. Risk Assessment and Risk Management Methods

Page 65: Clarifying text added: “The risk assessment process incorporates the best available data on the potential health effects of a nanomaterial and the exposure potential to humans and to the environment; thus, the data needs described in previous chapters and the quality of the results of studies in measurement, exposure assessment, human health, and the environment directly impact the reliability of risk estimates.”

Page 66: All research needs bullets updated.

Page 73: Significant new text added under Analysis of Current Projects

Page 77: New text: “Risk communication should also be appropriately tailored to the targeted audience. As a result, different approaches may be used to communicate risk(s) by Federal and state agencies, academia, and industry stakeholders with the goal of fostering the development of an effective risk management framework.”

7. Informatics and Modeling for NanoEHS Research

Page 80: New text: “Identifying regions in which small changes in nanomaterial structures lead to large differences in their properties (high sensitivity) and/ or large uncertainty and error in the data or models would provide a quantifiable measure of the need for greater understanding of the underlying mechanisms and help target priority areas for additional research and funding.”

8. The Path Forward

Page 95: Expanded bullet “ Name NNCO EHS Coordinator. Consistent with the PCAST recommendation, OSTP has named an NNCO Coordinator for EHS to assist agencies in integrating research across the nanoEHS continuum to achieve the objectives presented in the NNI 2011 Strategic Plan. The new NNCO EHS Coordinator serves on the NSET/NEHI leadership team; leads the NNCO and NSET Subcommittee’s efforts in identifying and leveraging research collaborations domestically and internationally; serves as the NNI point of contact for stakeholders with nanoEHS concerns; and spearheads the NNI EHS Research Strategy’s implementation, coordination, and evaluation.”

Page 95: New bullet “Refocus NEHI. Through consultation with agency representatives, the leadership of the NEHI Working Group adapted its meeting format to ensure better coordination of research to achieve the goals of the NNI EHS Research Strategy. Four priority areas were identified: ongoing updates on agency nanoEHS activities; new opportunities for collaboration; research strategy implementation, coordination, and evaluation; and planning and outreach.”

Comparing the final strategy to public comments from Günter Oberdörster on the draft document. I decided to do this as Günter provided some of the most specific public comments, and because he is one of the most respected experts in the field.  The specificity of his comments also provided an indication of the extent to which they had been directly addressed in the final strategy.

Comment: Page 31, lines 7-13: Although the need for developing appropriate, reliable, etc. in vitro and in vivo assays need to be identified, this need could include and emphasize the validation of any in vitro system through in vivo studies. In addition, the choice of realistic, relevant doses/concentrations should be informed by data from exposure assessment which should be stressed.

Response: New bullet added.

Comment: Page 31, line 35: The nose is listed here as a non-traditional route of entry, it certainly is not, nasal and oral inhalation are both very traditional portals of entry.

Response: The recommended change made here, but not later on in the strategy.

Comment: Page 32, lines 3 and 4: When designing dose response and time course studies, the need for inclusion of realistic doses should be mentioned.

Response: No obvious response.

Comment: Page 32, lines 9 and 10: Likewise, with respect to alternative in vitro testing methods for rapid screening, it should be emphasized again that validation is necessary since mechanisms are dose-dependent and mechanisms associated with extraordinarily high doses in vitro are likely not to operate in vivo. So the predictability of in vitro assays for in vivo responses clearly needs to be confirmed.

Response: No obvious response.

Comment: Page 35, lines 3-14, Overview: In this well-written overview section, I would like to see more emphasis on a validation of in vitro assays by in vivo studies; just pointing to the correlation (correlation which way?) of in vitro results with in vivo outcomes is not strong enough in my view. It should be pointed out in this section that the term in vivo also requires some scrutiny with respect to methodologies: for example, inhalation as the preferred method is clearly the gold standard as far as the respiratory tract as portal of entry is concerned, yet bolus type delivery (instillation, aspiration) are continuously used, calling for a need to compare different in vivo types of exposure to assess their usefulness. (Differences in dose-rate as important determinant of acute effects).

Response: No obvious response

Comment: Page 37, lines 15-29, Overview: This section again is a good overview, however, it could be more specific with respect to what are the goals of biokinetics, which are described here as developing models that predict ENM biological exposure and fate. Important in addition is to identify from such biokinetic studies potential target tissues/organs. Specifically, sensitive tissues could be mentioned, such as bone marrow, CNS, cardio-vascular system, placenta, the latter pointing to the potential of reproductive effects.

Response: No obvious response.

Comment: Page 38, lines 38-45: This overview of ENM uptake and portal of entry tissues addresses also the issue of inhalation vs. intratracheal instillation as well as use of high exposure doses. However, it appears that for the instillation methodology (aspiration should be mentioned also, both together to be described as acute bolus type deliveries) by-passing of the upper respiratory tract is identified as the only limiting factor with respect to risk assessment. However, a major problem not mentioned here is the difference in dose rate between inhalation and bolus type delivery, in addition to differences in distributions of deposited doses in the lower respiratory tract.

Response: No obvious response.

Comment: Page 39, lines 34-46, Overview: The need for fundamental understanding of the mode of action is addressed here, and it would be helpful to remind the reader that mechanisms also are dose-dependent, and that therefore the identification of molecular mechanisms mediating biological responses also require to make certain that they are operating in vivo, particularly in case they are derived from high-dose in vitro studies.

Response: No obvious response.

Comment: Page 56, lines 9 and 10: A minor point, I suggest to reverse these two lines, to place Hazard Identification first, followed by Risk Characterization, which is dose-response assessment.

Response: This section was changed substantially.

Comment: Page 68: This last section on Informatics and Modeling identifies some problems with regard to setting up a better collaborative infrastructure considering, among others, the policies and practices of different agencies (line 5), funding mechanisms and funding evaluation schemes, etc.; but there doesn’t seem to be a solution offered to solve these problems although there is some attempt in the last section, The Path Forward (see below).

The Informatics section is very useful, in particular also since it emphasizes the importance of validating predictive capabilities of in vitro and in vivo assays (lines 17 and 25) and to incorporate necessary additional information. It would be helpful to add a short paragraph about the time line of informatics, obviously these are long-term goals, can you provide any milestones for the goals? [Not addressed, as far as I can tell]

Pages 70/71, Path Forward: With respect to targeting and accelerating HS research, six bullet-points are listed, however, an overarching issue that could be introduced here (it comes several pages later) is that there ought to be a coordinating oversight body, otherwise, it might be just a continuation of how it is now.

Response: No obvious response.

Comment: Page 71, line 22: Dosemetrics such as surface area and solubility are listed as something new which certainly is not the case. Otherwise, this listing of prioritized research is well developed and makes good sense.

Response: No obvious response.

Comment: Page 77, lines 2-7, Implementation and Coordination: The essentiality of continuous coordination among agencies through the NEHI working group and addition of an NNCO coordinator is expressed. This sounds pretty good, how well will it work though? This document lists many projects for each of the research needs, but there was not much evidence of inter-project collaboration/discussions.

Response: No obvious response.

Comment: Page 78, first bullet-point, lists the new NNCO coordinator but it is not clear what, if any, directive power this coordinator will have? Just assisting agencies may not be enough.

Response: Role clarified, but comment not addressed.

Comment: Page 78, (Lines 4-9) In addition, the NEHI working group will continue to facilitate coordination and increased collaboration among the agencies, so it is not clear really how these two coordinating groups work together and how much of a directed coordinated agenda for accelerated EHS research is now in place or how is that different from the past? The NEHI working group is continuing its coordinating efforts nationally and internationally, so what is the role of the new NNCO coordinator?

Response: Text clarified.

Comment: Page 79 discusses very nicely the dissemination of knowledge and comes up with a Conclusion Paragraph. However, in both of these the NNCO coordinator is not mentioned, so how important really is this coordinator? Role of the NNCO needs to be better clarified.

Response: No obvious response.

Comment: Page 91, Appendix C. Definitions — Nanoparticle or nanoscale particle: Text reads: “ … a nano-object with all three external dimensions …” — should be “…at least one external dimension….”.

Response: Comment addressed.

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

Here’s the full text of the definition:

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

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

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

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

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

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

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

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

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

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

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

Particular points of interest here include:

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

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

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

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

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

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

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

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

Cross-posted from The Risk Science Blog:

In a recent letter to the journal Nature (Nature 476; 399), Hermann Stamm of the European Commission Joint Research Centre Institute for Health and Consumer Protection (JRC-IHCP) defended the need to define engineered nanomaterials for regulatory purposes. The letter, titled “Nanomaterials should be defined”, was a direct response to my earlier commentary in Nature “Don’t define nanomaterials”.

Stamm’s letter is behind a paywall and so not easily accessible to many readers. But these are the main points he makes:

• A definition for engineered nanomaterials is required for labeling purposes, and would assist industry and regulators in identifying where specific safety assessments might be necessary.
• This should identify a general class of materials for attention, whether they are benign or hazardous.
• Nanomaterials have many properties not shared by their larger-scale counterparts, some of which have safety implications. And an increasing number of products containing novel nanomaterials are entering the market.
• Engineered nanomaterials are heterogeneous. But, they all have structures on the nanoscale which modify their other properties. Because of this, size is therefore most appropriate parameter to base a regulatory definition on.

Stamm also references a Joint Research Center Reference Report on “Considerations on a Definition of Nanomaterial for Regulatory Purposes”, co-authored by him and published in 2010.

As is probably clear from my Nature commentary (an early draft is freely available here), I have some sympathies with the challenges the JRC and regulators across the world are facing. Without a doubt, sophisticated materials arising from nanoscale science and engineering are presenting safety challenges that are not readily captured by current regulatory regimes. Yet I am increasingly concerned that, with the momentum that has built up behind the field of nanotechnology, it is becoming increasingly difficult to formulate evidence-based questions that will lead to science-justified regulation. And despite policy makers repeatedly stating that any form of nanomaterial regulation should be science-based, I have the sense that they are scrambling to use science to justify a predetermined conclusion – that engineered nanomaterials should be regulated on the basis of a hard and fast definition – rather than using science to guide their actions.

Instead, I would suggest that we need to put aside preconceptions of what is important and what is not here, and start by asking how new generations of sophisticated (or advanced) materials interact with biological systems; where these interactions have the potential to cause harm in ways not captured within current regulatory frameworks; and how these frameworks can be adapted or altered to ensure that an increasing number of unusual substances are developed and used as safely as possible – no matter what label or “brand” is applied to them.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A busy week for nanotechnology regulation!

White House Memo on Nanotechnology Regulation Policy Principles

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

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

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

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

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

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

EPA Draft Pesticides and Nanomaterials Policies

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

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

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

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

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

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

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

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

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

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

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

FDA Draft Guidance for Industry on Products and Nanotechnology

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

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

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

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

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

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

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

The guidance goes on to state

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

FDA is clearly aiming for responsive and adaptive regulation here.

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

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

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

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

_____________

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

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

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

I thought I’d post this spoof presentation for the fun of it on the responsible development of “unobtainium”, which seems to have some remarkable similarities with some other emerging technologies:

Last week, the Victoria branch of the Australian Education Union (AEU) passed a resolution recommending that “workplaces use only nanoparticle-free sunscreen” and that sunscreens used by members on children are selected from those “highlighted in the Safe Sunshine Guide produced by Friends of the Earth” as being nano-free.  The AEU also resolved to provide the Friends of the Earth Safe Sunscreen Guide and Recommendations to all workplaces their members are associated with.  Given what is currently known about sunscreens – nano and otherwise, I can’t help wonder whether this is an ill-advised move.

The debate over the safety or otherwise of nanoparticle-containing sunscreens has been going on for over a decade now.  Prompted by early concerns over possible penetration through the skin and into the body of the nanosized titanium dioxide and/or zinc oxide particles used in these products – and potential adverse impacts that might result – there has been a wealth of research into whether these small particles can actually get through the skin when applied in a sunscreen.  And the overall conclusion is that they cannot.  There have been a small number of studies that demonstrate that, under specific conditions, some types of nanoparticle might penetrate through the upper layers of the skin.  But the overwhelming majority of studies have failed to find either plausible evidence for significant penetration, or plausible evidence for adverse health impacts – a body of evidence that led the Environmental Working Group to make an about-face from questioning the use of nanoparticle-containing sunscreens to endorsing them in 2010.

So why is the AEU now advising against their use?  And why are they advocating selecting sunscreens based on a document that does not provide evidence-based advice on efficacy or safety – and may end up leading to decisions that increase the risk of sun-related skin damage in children (more on this below)? (Update 5/25/11 – see notes below)

In part, the answer lies in the uncertainty inherent in proving anything safe.  It’s not too difficult to show that something is unlikely to be harmful, or is probably safe.  But proving something is absolutely safe under all conditions of use is simply not possible – there is always some room for doubt.  This is why decisions on health risks are typically based on plausible risk and weight of evidence – evaluating the most reasonable and defensible interpretation of the data, and not basing decisions on speculation and fantasy.

With the use of nanoparticles in sunscreens, the weight of evidence is that they are safe and effective – and may be safer and more effective than a number of non-nanoparticle alternatives as they work by coating the skin rather than being absorbed into it.  That said, it’s always prudent to check whether anything has been missed with a relatively new technology like this, and so research is ongoing just to make doubly sure that the nanoparticles currently being used stay on top of the skin, and that manufacturers are using the safest possible types of nanoparticles.

But there is another reason I suspect why the ASU have released this advice, and that is due to a study using human volunteers that was published last year.

In this study by Brian Gulson and colleagues, sunscreens were formulated with zinc oxide particles made from a stable isotope of zinc that doesn’t occur in great abundance naturally: Zn-68. Using Zn-68 as a tracer, they were able to tell whether zinc from the applied sunscreen entered the bodies of the volunteers, and ended up in their blood and urine.

The detected presence of Zn-68 in the urine and blood of volunteers was used by Friends of the Earth Australia to renew their recommendations against using nanoparticle-containing sunscreens until more is known about their safety in.  And given the ASU’s reliance on the Friends of the Earth document, it seems to have influenced their decision to recommend not using nanoparticle-containing sunscreens.

But what does the Gulson study actually conclude?  In a nutshell, the researchers showed that:

• Small amounts of zinc from sunscreens containing any form of zinc oxide particles tested found their way into the blood and urine of volunteers.
• The amounts of zinc entering the body over the five day study were miniscule – around one thousandth of the concentration of zinc already in the volunteers’ bloodstream, and around one thousandth of the amount of zinc recommended in a person’s daily diet.
• Women in the test generally showed higher uptakes of zinc than men.
• Zinc levels in blood associated with the sunscreen peaked some days after applications ended, suggesting the zinc or zinc oxide was stored somewhere in or on the body and slowly released.
• For men, zinc uptake from sunscreens was independent of particle size.  For women, zinc uptake was greater from the sunscreens containing smaller particles.

So did the particles go through the skin?  The study only showed that the zinc passed through the skin, and did not provide any evidence of particle penetration.  Two possible explanations for this are that the particles penetrated and entered the bloodstream, or that the applied particles dissolved, and that it was dissolved zinc that was penetrating into the body.

Out of the two possibilities, there is minimal evidence for particle penetration being a plausible mechanism. On the other hand, zinc oxide is sparingly soluble, and under the acid-conditions of the outer layers of the skin the particles would have readily released zinc ions.  The weight of evidence to date therefore strongly supports dissolution of the particles and subsequent dermal penetration of dissolved zinc.  This is supported by the similarity in uptake seen in men of zinc for two different sizes of zinc oxide particles.

In other words, this study provides neither compelling evidence that nanoparticles in sunscreens can pass through the skin, or that they can lead to worrying internal exposure to harmful materials.  It did indicate on the other hand that any sunscreen containing zinc oxide will lead to zinc entering the body via the skin – including sunscreens that rely on large zinc oxide particles.

And this is where it is worth returning to the Friends of the Earth recommendations.

The Friends of the Earth Safe Sunscreen Guide recommends:

Use a nano-free zinc-based SPF 30+ broad spectrum sunscreen in conjunction with protective clothing, a broad-brimmed hat, sunglasses and shade to stay sun safe.

It goes on to list sunscreens that are “nano and chemical free”, “may use nano” and “use nano” (based on information from manufacturers and assumptions from Friends of the Earth).

Passing over the fact that Friends of the Earth are advocating the use of sunscreens that demonstrate the same behavior – zinc penetration through the skin into the body – as the sunscreens they recommend people don’t use, it’s hard to understand how this document provides an authoritative and evidence-based guide for the use of sunscreens on school children – as suggested by AEU.

For a start, this is a document that is specifically concerned with nanoparticle-containing sunscreens, and is not aimed at providing advice on selecting sunscreens as a whole based on their safety and efficacy.  It is advocating a specific course of action, and is not a tool for taking informed action. And in this respect alone it is a questionable document to be distributing to school workers. But it gets worse.

The sunscreens listed in the document are listed solely with respect to their nanoparticle content.  There is no – let me repeat that no – information on how effective these sunscreens are at protecting against UVA and UVB, and what the specific safety issues associated with their use are (update 5/25/11 – see notes below).  What is more, the top tier products – those that appear to be most strongly endendorsed by Friends of the Earth – also claim to be “free of UV-absorbing chemicals”.  In other words, this is a document that appears to be endorsing the use of products that do not necessarily protect against ultraviolet light. (Update 5/25/11 – see notes below).

To be fair to Friends of the Earth – and this is not a critique of their document so much as a questioning of its use as authoritative guidance – they do recommend the use of sunscreens providing substantial UV protection that are (presumably) based on large zinc oxide particles.  But if school workers were to base their choice of what to slather onto kids on the list of products, rather than the one sentence top level recommendation, they could well be applying sunscreens that do not protect against skin damage.

And this is my greatest concern here – by advocating the use of the Friends of the Earth document, AEU could actually be endangering the health of children in the care of their members. (Update 5/25/11 – see notes below)

Of course, there are important issues to grapple with here – including how appropriate sunscreens should be selected for use on children, irrespective of the technology being used.  But surely these selections should be based on the best possible evidence that is focused on what is most appropriate for the children, and not on an action campaign by an advocacy group, no matter how well intentioned.

Update, 5/25/11:  As clarified by Georgia Miller of Friends of the Earth Australia in the comments below, the sunscreens listed in the top tier of the Friends of the Earth document are all – as far as I can tell – marketed as offering SPF 30 + protection.  This is something that I do not think is explicitly clear in the document, and the heading of “nano and chemical-free”, clarified with “products also free of UV-absorbing chemicals” raises an obvious question to the naive reader over whether these products do indeed offer significant protection.  I also continue to have serious reservations over the use of a document designed to steer people away from nanoparticle-containing sunscreens as authoritative advice on sunscreen protection for children, given it’s lack of independent testing and evaluation of all significant factors that might affect choice in a given situation.  Nevertheless, given the protection ratings of the recommended sunscreens, I have on reflection retracted the statements made in regard to the protection offered above.

A few weeks ago, the US National Nanotechnology Initiative website – www.nano.gov – underwent a much-needed facelift.  The NNI’s web portal was creaky when I was part of the Initiative several years ago now.  And it’s somewhat ironic that the world’s leading interagency initiative on one of the most prominent cutting edge technology platforms has relied on a website that is the antithesis of technology innovation for over a decade.  So I was pleasantly surprise to see the other week that the site has been updated, streamlined, and made more accessible, attractive, and – dare I say – useful.

The update has been in the works for a while now – I was one of a number of people asked about the old site and what improvements could be made well over 12 months ago.  Fortunately, despite the slow pace of progress, it looks like the changes have been worth waiting for.

Glancing around the new and improved site, the designers and NNI have done a good job.  Useful information on nanotechnology and the initiative is now far easier to find.  Information on stuff like current funding opportunities and recent reports is now clearly accessible from the home page.  It’s a cinch to find out more information about the Initiative and its member agencies.  Heck, you can even follow the NNI on Twitter now!

I particularly appreciate the new search page for NNI publications and resources.  If you are looking for specific resources from 2008 onwards, it’s easy to pull them out using the search interface.  The downside is that if you want anything before 2008, things are a little trickier – the search date fields don’t allow you to easily enter dates before January 1 2008 (although bizarrely you can search for stuff published between 2012 – 2014 – maybe time travel is a little-touted side-project of the NNI!).  Fortunately, you can enter earlier dates manually though – although you can’t see what you are typing.  Using this workaround, I managed to pull up some of the pre-2000 NNI documents, although I did notice that some of the early Interagency Working Group on Nanotechnology documents (the precursor of the NNI) were missing.

I’m not sure how much substantive new content has been added to the site with the update – although clearly there is some.  But at least in style and accessibility, the NNI now have a web portal that is commensurate with the technology it promotes.

________________________

For nano-geeks, this is what the NNI website looked like on November 12 2010:

(You can access the archive by clicking on the image, but it will take a while to load).

And this is what it looked like on April 7 2000 (the earliest archived copy I could find):

Admittedly, the 2010 version was rather slicker that the 2000 version.  The basic design that has just been superseded dates back to 2004.

Tomorrow, I will be speaking at the Marshal M. Weinberg Seminar on Optogenetic Manipulation of the Brain at the University of Michigan – not a subject I must admit that I am that familiar with.  Fortunately, there are other speakers who will be doing much of the heavy-lifting, including Karl Deisseroth – a leading optogenetics researcher, and author of a recent in-depth article in Scientific American on controlling the brain with light.  My role – I suspect – is to bring a broader social and technological perspective to the benefits and risks of this rapidly emerging field as part of the closing panel discussion – neatly titled “Mind Control: What do you think?”

Here, I must confess that I’m going to be relying an awful lot on the preceding talks to round off my education in optogenetics before I launch in.  But I have been doing some preparatory work on optogenetics, and in particular the plausibility of its possible use in manipulating brain function at a sophisticated level.

By way of background, optogenetics is a relatively young field that revolves around the study and use of specific genetic sequences – opsins – to enable the modulation of cellular and sub-cellular processes in the presence of light.  Its roots stem back to early research into optically-modulated biological processes in microorganisms.  But it wasn’t until a number of fields began to converge that the possibility of utilizing these seemingly esoteric processes began to emerge.

For decades now, it has been known that some microorganisms have the ability to respond to light by producing  proteins that switch or otherwise modify specific cellular processes. This might have remained a curiosity if it wasn’t for the increasing ability to cut and paste functional genetic sequences from one species to another, and the realization that to control many cell-level biological processes, fast, precisely timed pulses of light could provide a control mechanism that overcomes the limitations of electrical and chemical alternatives.  The result has been the emergence of optogenetics as a well-defined field – in Deisseroth’s words

“the use of optics and genetics to control well-defined events within specific cells of living tissue”.

Optogenetics includes the discovery and insertion into cells of genes that enable them to respond in specific ways to light… It also includes the technologies that enable the delivery of  light deep within complex organisms to control light-sensitive processes at the cellular level, and technologies for monitoring and assessing the results of this optical control.

One of the more high profile application areas of optogenetics is in understanding the brain and intervening in neural processes.  Deisseroth again:

What excites neuroscientists about optogenetics is control over defined events within defined cell types at defined times—a level of precision that is most likely crucial to biological understanding even beyond neuroscience. The significance of any event in a cell has full meaning only in the context of the other events occurring around it in the rest of the tissue, the whole organism or even the larger environment. Even a shift of a few milliseconds in the timing of a neuron’s firing, for example, can sometimes completely reverse the effect of its signal on the rest of the nervous system. And millisecond-scale timing precision within behaving mammals has been essential for key insights into both normal brain function and into clinical problems such as parkinsonism.

The possibilities here are tremendously exciting.  But they also raise whole rafts of questions over the dangers and ethics of meddling with the brain – and by extension the mind.  What are the possibilities of dual-use technologies that can lead to questionable as well as acceptable control?  Could optogenetic “mind control” lead to significantly altered personalities – and if so, who is responsible for the results?  Might optogeneticically modulated individuals be “hacked” – enabling third parties to gain control over their decisions and actions?  And what are the ethical boundaries to developing and using technologies that depend on genetic, physiological and psychological manipulation of subjects?

These are all questions that are ripe for serious discussion.  But to be productive, they must also be grounded in scientific and technological plausibility.  It’s easy to imagine what might be achieved by optogenetics through extrapolation and speculation.  But given realistic scientific and technological constraints, what is is plausibly likely to be achieved?

Reading up on the state of the science as it stands now, it seems that concerns over the nefarious use of optogenetics for sophisticated mind control are probably premature.  The brain is a hugely complex organ, and sophisticated as current technologies seem, we are still a long way from being able to understand, control and manipulate it with any real dexterity.  In fact, worrying too much about mind control at this point is probably the equivalent to jumping straight from using crude saws to amputate damaged limbs to worrying about the implications to advanced brain surgery.  Nevertheless, in preparation for tomorrow’s panel discussion, I though it worthwhile spending some time thinking about the technologies that could potentially bring sophisticated mind control closer to being a reality.

Over the next decade or so, getting new genetic sequences into neurons will probably be less of a challenge than getting short, precisely-timed pulses of light to neurons deep within the brain.  We already have a number of technology platforms that are actively being explored on this front.  On the other hand, the ability to channel pulses of light to small and highly localized volumes deep within the brain still presents huge challenges.  So what are the options here, and where might the technology develop?

Advances in fiber-optic probes are beginning to open up deep brain optical stimulation, and offer the possibility of stimulating relatively small volumes on demand.  But the spatial resolution achievable is still coarse, and will probably remain so as there is a limit to how many probes can be inserted into a brain.  This technology may well prove suitable for modulating brain function in very basic ways – possibly to a sufficient degree to aid patients with conditions such as Parkinson’s disease.  But insertion of fiber-optic probes lacks the finesse required for sophisticated manipulation.  And of course, there is the hassle of both inserting the probes, and having them present as a permanent fixture for as long as the stimulation is required.

High density and highly localized probes that are hard wired to the external world ideally requires a dense network of probes that are organically “grown” through the brain – a technology I am sure will remain in the realms of science fiction for my lifetime at least.  If such a technology could be developed, it would enable high spatial resolution optical stimulation, opening up the possibility of fine-tuning optogenetic control to small clusters of neurons.  But while nanoscale regenerative medicine is making interesting breakthroughs in self-assembling biocompatible structures, it is hard to imagine these translating into useable optogenetic neural nets any time soon.

There is another possible route to high resolution and highly localized stimulation though, which isn’t too dissimilar to the sci-fi concept of a optogenetic neural net.  Imagine that you could place the equivalent of millions of fiber optic probe tips through the brain, and then communicate with them wirelesly – you would have the equibalent of the neural net, without the net part.

Fanciful as it may sound, it’s and approach that has already been used to develop cellular and sub-cellular probes.  PEBBLE technology – Photonic Explorer for Biomedical use with Biologically Localized Embedding technology – has been under development for some years for tracking biological processes in situ.  Could a similar technology be used for wireless neurogenetic control?

Imagine a biologically benign nanoparticle that could be stimulated to emit light of a given wavelength in the presence of a specific electromagnetic field.  If these particles could be diffused throughout the brain, local stimulation might be possible by using focused electromagnetic fields.  Wireless optogenetic control.

Of course, there are tremendous technical barriers here – not least engineering particles that are able to pick up and respond to specific signals.  But our ability to engineer nanomaterials to exhibit non-liner interactions with electromagnetic fields and to exploit these interactions may help us to overcome overcome this particular barrier.  Even then though, there is the challenge of focusing these fields to within precise volumes within the brain in order to elicit the desired effect.

Plausible I suspect, but extremely time consuming and cumbersome.

But what if the nanoparticles could be programmed to respond to specific stimuli once in place?  Imagine a sophisticated nanoparticle that, in the presence of a high intensity electromagnetic field, can be programmed to respond to a specific lower intensity field by emitting light of a given wavelength.  A subject’s brain could be infused with the nanoparticles, and particles within specific regions of the brain subsequently programmed to respond to stimuli that might be distinguished in terms of their frequency, intensity or time/phase modulation.  All that would then be needed to “control the mind” of the subject would be to subject them to electromagnetic fields with the appropriate characteristics – and this is the important part – without needing a high level of spatial resolution.

In effect, once programmed, a simple wide-field transmitter could be used to send signals to very specific parts of the subject’s brain.  And if the responses weren’t quite what was wanted, there is no reason why the nanoparticles couldn’t be reset, ready for the next round of programming. In other words, you would have the neural equivalent of an old-style computer EPROM (Erasable Programmable Read Only Memory) – an Erasable Programmable Nanoparticle Optogenetic Control device, or EPNOC!

Plausible?

Borderline most likely I suspect.  But not beyond the realms of possibility.

Delivery of spatially dense and highly localized pulses of light is key to optogenetics being used for sophisticated mind control.  If we cannot achieve it, the technique is likely to remain a blunt – albeit still very valuable – instrument.  But if technology platforms such as nanotechnology do begin to converge more fully with optogenetics, we may see some interesting, possibly startling and undoubtedly challenging advances over the coming decades.

Maybe not mind control, but certainly more brain manipulation than has ever before been in our grasp.

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

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

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

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

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

The recently published International Handbook on Regulating Nanotechnologies has a rather unconventional cover image. But it’s one that I must confess I am rather pleased with.

The image is a photo of a piece of Murano glass that I picked up several years ago while visiting Venice. At the time I was participating in a nanotoxicology conference, and so was sensitized to all things nano. Taking some time out to wander round the glass showrooms of Murano, I was struck by the deep red glass that a number of the pieces were showcasing. The coloring comes from the glass being infused with gold nanoparticles – a technique that dates back to medieval times, but is especially associated with the artisans of Murano. Given the nanoparticle connection, I picked up this particularly eye-catching piece, thinking that it might come in useful some day.

The original inspiration for the book cover

Fast forward a few years to the final stages of pulling the International Handbook on Regulating Nanotechnologies together. As we neared completing the book, my co-editors Graeme Hodge and Di Bowman and I were looking for an arresting image for the book’s cover. At the time, my daughter was taking a photography class at school, and had just taken an abstract image of my Murano glass piece. As a photo, it worked rather well, and got me thinking about whether I could finally use the piece for something nanotech-related.

Examining the piece more closely, it struck me that there was scope here for a rather sophisticated image that illustrated the challenges of regulating nanotechnologies on multiple levels. On one level, the piece used gold nanoparticles to achieve a specific effect. On a more abstract level, the nanoparticles were used to illustrate an ordered array of circular objects – a little reminiscent of an ordered array of nanoparticles. Then, these objects were multi-layered – hinting at the sophistication that can now be achieved in engineering nanometer scale structures with multiple components.

So the piece took on the role of an elegant and sophisticated metaphor for nanotechnology, that incorporated the technology within the metaphor itself.

But what persuaded me that this might be an image that would work on the front of a book about regulation was an intriguing question that the piece raised. Even though the technology used to color the glass uses nanoparticles, the technology could hardly be termed nanotechnology when it was initially developed – simply because the artisans had no idea that the effect they were achieving was due to these small, uniform particles in the glass. But now we know that this is the cause of the effect. And artisans continue to utilize the technology with the full knowledge that it is associated with uniformly sized nanometer diameter particles of gold infused through the glass. Does this conscious understanding and use make it nanotechnology? And does that mean that we need to ask new questions about how the technology is regulated – even though it’s been around for thousands of years?

These are some of the overarching questions that we and our co-authors were grappling with in the book. So it made perfect sense to use the image as a metaphor for the the challenges we face in regulating nanotechnologies – or even formulating the questions we need to address.

And, as it turns out, it doesn’t look half bad!

From the book cover:

An abstract image realized in contemporary glass, from the Venetian island of Murano. The deep red coloring results from the glass being infused with gold nanoparticles, a technique used by artisans lung long before it was realized that the effect was due to the size of the gold particles suspended within the glass. The regular array of concentric geometric shapes is an apt metaphor for the complexity of engineered nanomaterials, where useful attributes arise from controlling how matter is structured from the nanoscale up to the scale of everyday objects. But it also poses an intriguing question in the context of regulation: now that the artisans know the glass gets its unique properties from nanometer-scale gold particles – and can presumably better control it as a result – is it nanotechnology?

Cross-posted from the Risk Science Blog

]]> http://2020science.org/2011/02/26/the-art-of-regulating-nanotechnologies/feed/ 3 http://2020science.org/2011/02/09/the-new-toxicology-of-sophisticated-materials-nanotoxicology-and-beyond/ http://2020science.org/2011/02/09/the-new-toxicology-of-sophisticated-materials-nanotoxicology-and-beyond/#comments Wed, 09 Feb 2011 15:28:38 +0000 Andrew Maynard http://2020science.org/?p=4084

Cross-posted from The Risk Science Blog

Several months ago, I was asked by a colleague if I fancied co-authoring a review on nanotoxicology for a copy of Toxicological Sciences celebrating the 50th anniversary of the Society of Toxicology (coming out later this year).

Fool that I am, I agreed.  Interestingly though, as I and my co-authors (Martin Philbert and David Warheit) grappled with a topic we were all, to be frank getting a little fatigued with, it became clear that “nanotoxicology” as it is currently understood is merely a step towards a much bigger field of the “new toxicology of sophisticated materials”

The review is currently available here as an Advance Access publication from Toxicological Sciences.  In it we start by reviewing the history of the emergence of nanotoxicology as an integral part of the field of nanotechnology, and continue to examine some of the key toxicology-based challenges presented by engineered nanomaterials.

Yet we conclude that, despite the current flurry of activity in researching the toxicity of nanomaterials, the field of nanotoxicology is suffering from something of an identity crisis:

“There is a strong sense that emerging, novel and complex materials that have been engineered at the nanoscale may exhibit unusual or unanticipated toxicity from a conventional perspective, and that research is needed to understand and address how these designed-materials might cause harm in ways that are not readily understood at present. This concern is supported by a growing body of research which indicates that some nanometer scale materials do demonstrate biological behavior that is mediated by physical form as well as chemical composition. Yet a clear identification and formulation of the problems being faced remain elusive.

For example, what is meant by the “nanoscale” is far from clear, meaning that there is considerable ambiguity over which materials are embraced by “nanotoxicology.” Widely accepted definitions of nanotechnology refer to a size range of approximately 1 – 100 nm “where unique phenomena enable novel applications”. Yet these are largely definitions of convenience, not of science. And while the definitions defining the field of nanotechnology have been important in driving new science and technology   innovation, it is not clear how they apply to a new material’s propensity to cause harm in unexpected ways.”

This is not to say that the questions and issues raised by nanotoxicology are not important.  On the contrary, we note that

“there is an array of increasingly sophisticated materials that are emerging from advances in science, technology and engineering that do demand careful consideration of the new risks they might pose.”

But we suggest that new thinking on how the potential safety challenges presented by these “sophisticated materials” is needed.

“In this respect a differential approach to toxicology studies is required – one which helps identify where emerging materials and products deviate from established ones in their potential to cause harm, and focuses research on narrowing the resulting knowledge gap.

Undoubtedly, materials intentionally designed and engineered to behave in specific ways because of their fine structure are at the forefront of the new challenges being faced in toxicology. These materials increasingly demonstrate biological behavior that results from a synergistic interaction between chemical composition and physical form. But whether these new challenges can be confined to a narrow size scale implied by “nanotoxicology” is debatable.

Rather, we would argue that a broader perspective is needed on the challenges presented by novel and functional materials, that captures the idea of “sophisticated materials.” These are substances that arise at the intersection of scientific disciplines and technology platforms, and demonstrate novel and even time and context-dependent functionality based on their engineered and increasingly complex physicochemical structure.

While many of these materials will depend on nanoscale engineering, decoupling the materials from the underlying technology – or technologies – is helpful in formulating science-based questions regarding their toxicity. In this respect, the toxicology challenge presented by sophisticated materials is to understand and address the hazards presented by materials that have the ability to enter the body, interact with it and elicit an adverse response in ways that are not adequately understood through a conventional and chemical composition-dominated perspective on toxicology.”

We conclude the review by suggesting that

We can now begin to appreciate the challenges presented by simple nanoscale materials such as TiO2, ZnO, Ag, carbon nanotubes and CeO2. But these simple materials are merely the vanguard of a new era of complex materials, where novel and dynamic functionality is engineered into multifaceted substances. If we are to meet the challenge of ensuring the safe use of this new generation of substances, it is time to move beyond “nano” toxicology and towards a new toxicology of sophisticated materials.

Maynard, A. D., D. Warheit and M. A. Philbert (2011). “The New Toxicology of Sophisticated Materials: Nanotoxicology and Beyond.” Tox. Sci. Advance Access.  DOI: 10.1093/toxsci/kfq372

Next Tuesday, we’ll be launching a new series of occasional discussions on contemporary public health risk issues at the University of Michigan Risk Science Center.  And the first topic is – no surprises – nanotechnology.

Under the tagline “No PowerPoint, no script; just stimulating conversation”, the Unplugged series will be engaging experts in lively conversation on a range of topics. Each event will be webcast (and archived), and will allow on-line discussion around the topic of focus.

Nanotechnology is the topic of the first event, being held on February 8. Under my “strict and provocative” moderation, three leading experts will engage in conversation about what nanotechnology is, what it’s significance to public health is, and how we as a society might exploit it safely and responsibly.

You can view the event on-line (or turn up for the live discussion if you are around in Ann Arbor).  You can also join the conversation by going to the Nanotechnology – Unplugged website.In fact, I’d really like to encourage as many people as possible to take advantage of this and post their questions and comments.  I’ll be doing my best to thread questions posted before and during the event into the discussion on the day.

Nanotechnology – Unplugged: Join the conversation on February 8 from 2:00 PM – 3:00 PM Eastern Time.

]]> http://2020science.org/2011/02/01/nanotechnology-unplugged/feed/ 3 http://2020science.org/2010/12/06/us-nanotechnology-environmental-health-safety-research-strategy-open-for-comment/ http://2020science.org/2010/12/06/us-nanotechnology-environmental-health-safety-research-strategy-open-for-comment/#comments Mon, 06 Dec 2010 23:24:49 +0000 Andrew Maynard http://2020science.org/?p=3889

The US National Nanotechnology Initiative’s latest iteration of its Environmental, Health and Safety Research Strategy has just been posted on-line for public comment.  Between now and January 6, anyone who is interested is encouraged to read the draft and comment on the on-line portal – hopefully sparking a dialogue which will strengthen the final document.

You may remember that the previous strategy was given a bit of a hard time by the National Academies of Science – less for its substance than for the way it was – or wasn’t – brought together in a research strategy.  It’ll be interesting to see how things have evolved over the past couple of years or so.

I haven’t read the draft strategy yet, but I’m hopeful that this will be a stronger document.  For one thing, it builds on input from a wide range of non-government experts.  For another, the feds have taken the bold but extremely welcome step of initiating a public review period.  This makes a lot of sense – it provides another chance to iron out those niggling mistakes that everyone makes while writing documents, and it helps a broader community to be a part of the process, rather than just passive recipients.

I’ll be posting comments on the draft over the next few weeks – within the constraint that I am currently also working on the National Academies panel developing a complementary strategy.  But in the meantime, I would encourage anyone with the slightest interest in the potential health and environmental impacts of engineered nanomaterials to read the report, and join the conversation.

The on-line portal can be accessed here.

And before I go, I can’t resist noting that, once again, comments are restricted to 4000 characters.  I am so tempted to tweet my comments, just to get into the spirit of things!  The good news is that multiple posts are allowed!

Friends of the Earth have just released a new report challenging claims that nanotechnology will lead to greener, more energy-efficient technologies, lower-impact technologies.

I’ve only had the chance to skim through the report so far, and so don’t have detailed comments on it.  But on my initial skim a number of things struck me:

• The report is written from a specific perspective that questions the validity of claims made of nanotechnology – especially that it will “deliver energy technologies that are efficient, inexpensive and environmentally sound”
• It is pretty comprehensive, covering nanotechnology and solar energy, wind energy, hydrogen energy, oil and gas extraction, batteries, supercapacitors, nanocoatings and insulators, catalysis and reinforced parts for airplanes and cars.
• However, it doesn’t cover all nano-applications in the energy sector.  Two examples are the use of heterogeneous catalysts in vehicle exhausts and to reduce the energy overheads of a multitude of processes, the use of nanomaterials to develop more efficient power lines.
• The report also tends to focus on areas where it is easier to construct position statements challenging statements on the positive use of nanomaterials.
• Nevertheless, it appears to be a significant and well-written counterbalance to publications that promote the benefits of nanotechnology in the energy sector without deep and critical evaluation of the pros and cons of the technology.

Are the issues raised valid and in need of further exploration?  It’s worth reading for yourself to decide.  I’ve included the executive summary below – the full report (88 pages) is available here. Agree or disagree?  Feel free to comment below!

In a world increasingly concerned about climate change, resource depletion, pollution and water shortages, nanotechnology has been much heralded as a new environmental saviour. Proponents have claimed that nanotechnology will deliver energy technologies that are efficient, inexpensive and environmentally sound. They predict that highly precise nanoman- ufacturing and the use of smaller quantities of potent nanomaterials will break the tie between economic activity and resource use. In short, it is argued that nanotechnology will enable ongoing economic growth and the expansion of consumer culture at a vastly reduced environmental cost.

In this report, for the first time, Friends of the Earth puts the ‘green’ claims of industry under the microscope. Our investigation reveals that the nanotechnology industry has over-promised and under-delivered. Many of the claims made regarding nanotechnology’s environmental performance, and breakthroughs touted by companies claiming to be near market, are not matched by reality. Worse, the energy and environmental costs of the growing nano industry are far higher than expected.

We also reveal that despite their green rhetoric, governments in the United States, Australia, the United Kingdom, Mexico, Japan and Saudi Arabia are using public funds to develop nanotechnology to find and extract more oil and gas. The world’s biggest petrochemical companies, including Halliburton, Shell, BP America, Exxon Mobil and Petrobras have established a joint consortium to fund research to increase oil extraction.

The performance of nano-based renewables has been considerably less than predicted. Efficiency of solar energy conversion by nano solar panels is still about 10 percent behind that achieved by silicon panels. The technical challenges of bringing renewable energy laboratory achievements to market have been prohibitive in many instances. The United States President’s Council of Advisors on Science and Technology states that in 2009 only one percent of global nanotechnology-based products came from the energy and environmental sector.
The energy demands and environmental impacts of manufacturing nanomaterials are unexpectedly high. Manufacturing carbon nanofibers requires 13 to 50 times the energy required to manufacture smelting aluminium, and 95-360 times the energy to make steel, on an equal mass basis. A team of United States researchers has concluded that single walled carbon nanotubes may be “one of the most energy intensive materials known to humankind”.

Due to the large energy demands of manufacturing nanomaterials, even some nano applications in the energy saving sector will come at a net energy cost. For example even though strengthening windmill blades with carbon nanofibers would make the blades lighter, because of the energy required to manufacture the nanoblades, early life cycle analysis shows that it could be more energy efficient to use conventional windmill blades.

Much-touted nano developments in the hydrogen sector are at a very early stage. It is improbable that cars powered by renewable energy generated hydrogen will be on the roads in the next ten or twenty years – the period in which emissions cuts are critical. In the meantime, development of hydrogen cars entrenches reliance on fossil fuels to produce the hydrogen.

Most nanoproducts are not designed for the energy sector and will come at a net energy cost. Super strong nano golf clubs, wrinkle disguising nanocosmetics, and colour-enhanced television screens take a large quantity of energy to produce, while offering no environmental savings. Such nanoproducts greatly outnumber applications in which nano could deliver net energy savings.

The environmental demands of nanomanufacturing are higher than that of conventional materials. Nanomanufacturing is characterised by very high use of water and solvents. Large quantities of hazardous substances are used or generated as byproducts. Only one tenth of one percent of materials used to manufacture nanoproducts found in computers and electronic goods are contained in the final products. That is, 99.9 percent of materials used in manufacturing become waste products.

Despite the serious uncertainties, there is a growing body of research demonstrating that some nanomaterials used in energy generation, storage and efficiency applications can pose health and environmental risks. Carbon nanotubes are touted for use in electronics, energy applications, and specialty car and plane parts. However, early research shows that some forms of nanotubes can cause mesothelioma, the deadly cancer associated with asbestos exposure.

The release of nanomaterials to the environment could also result in accelerated generation of potent greenhouse gas emissions. Antibacterial nano silver is used widely in clothing, textiles, cleaning products, personal care products and surface coatings. Yet preliminary study shows that when nano silver is exposed to sludge, similar to that found in typical waste water treatment plants, four times the typical level of the potent greenhouse gas nitrous oxide is released

Nanotechnology is not an unqualified environmental saviour nor will its widespread use in everything from socks to face creams enable us to pursue ‘business as usual’ while substantively reducing our environmental footprint. At best, such claims can be interpreted as the result of wishful thinking on the part of proponents; at worst they can be seen as misleading greenwash.

Nanotechnology is a powerful technology that has the potential to deliver novel approaches to the methods by which we harness, use, and store energy. Nevertheless, Friends of the Earth warns that overall, this technology will come at a huge energy and broader environmental cost. Nanotechnology may ultimately facilitate the next wave of expansion of the global economy, deepening our reliance on fossil fuels and existing hazardous chemicals, while introducing a new generation of hazards. Further, it may transform and integrate ever-more parts of nature into our systems of production and consumption.

Update 11/17/10:  Replaced local report links with link to FOE report web-page

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

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

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

PART I:    Concepts and Foundations

1.    Introduction: the regulatory challenges for nanotechnologies

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

2.    Philosophy of technoscience in the regime of vigilance

Alfred Nordmann

3.    Tracing and disputing the story of nanotechnology

Chris Toumey

4.    The age of regulatory governance and nanotechnologies

Roger Brownsword

PART II:    Frameworks for Regulating Nanotechnologies

5.    Nanotechnology captured

John Miles

6.    The scientific basis for regulating nanotechnologies

David Williams

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

Qasim Chaudhry, Hans Bouwmeester and Rolf F. Hertel

8.    Regulating risk: the bigger picture

Karinne Ludlow and Peter Binks

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

Thomas K. Epprecht

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

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

Oliver Tassinari, Jurron Bradley and Michael Holman

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

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

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

Markus Widmer and Christoph Meili

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

Geert van Calster and Diana M. Bowman

14.    Therapeutic products: regulating drugs and medical devices

Rogério Sá Gaspar

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

Anna Gergely, Qasim Chaudhry and Diana M. Bowman

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

Linda Breggin and John Pendergrass

17.    Military applications: special conditions for regulation

Jürgen Altmann

18.    Regulating nanotechnology through intellectual property rights

Gregory N. Mandel

PART IV:    The Future Regulatory Landscape

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

Georgia Miller and Gyorgy Scrinis

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

Christoph Meili and Markus Widmer

21.    The role of risk management frameworks and certification bodies

Thorsten Weidl, Gerhard Klein and Rolf Zöllner

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

Ortwin Renn and Antje Grobe

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

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

24.    Transnational regulation of nanotechnology: reality or romanticism?

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

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

J. Clarence Davies

PART V:    Conclusion

26.    Conclusions: triggers, gaps, risks and trust

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

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

This image from the first US National Science and Engineering Festival attracted my attention this morning:

It’s a wordle constructed from responses to the question “What will be the greatest discoveries and advancements science and engineering will bring us in the 21st century?”

What grabbed my attention was the prominence of nanotechnology in the mix – is awareness of nano finally on the up?

I’m not sure who or how many people responded to the question – it would be interesting to see if the organizers have more information on this.  But assuming that this represents a fair cross-section of people who participated in the Expo, it’s a fascinating snapshot of what is uppermost in people’s minds when it comes to science, technology and engineering.

You can read more about the first USA Science and Engineering Festival here.

A weekly reflection on life in academia

Most of this last week was spent in San Francisco, at the NISE Net (Nanoscale Informal Science Education Network) network-wide meeting – possibly my favorite meeting of the year (I might have mentioned that before).  This year I had the additional pleasure of opening the meeting in a double-act with Kathy Sykes.  Readers in the UK will be familiar with Kathy – for others, she is a rather smart scientist, communicator, broadcaster, science-festival co-director (she helped create and co-directs the Cheltenham Science Festival) and all-round good egg.  She is also a fellow physicist.  Two Brit physicists opening a US conference on informal science education – not bad eh!

One aspect of this meeting that I love – apart from the glorious location right by Fort Mason in San Francisco – is the eclectic and engaging mix of participants.  It’s one of the few meetings I know where artists, performers, teachers, exhibit designers, communicators, “natural” scientists  (bit of a dodgy term), social scientists and others can get together and share their knowledge around a common theme – in this case, nanoscale science and engineering.

I was here as a NISE Net advisor and as a keynote speaker (“Current perspectives on nanotechnology” – in 45 minutes!).  Because of this, I think people were expecting me to enlighten them (apart the person who asked in the bar “so what’s a Risk Science Director doing talking about nanotechnology?” – then sheepishly admitted the next day “I Googled you…”).  I may have said some useful things – it’s always hard to tell.  But what the organizers and participants probably don’t realize is how much I gained myself from the meeting.

As always it seems at this meeting, listening to and talking with other participants ended up influencing my own thinking about nanoscale science and engineering.  I came away with my brain buzzing with new ideas on how to approach and understand nanoscale science and engineering from a social and educational perspective – largely due to stimulating conversations with people having a very different training and perspective to mine.  What is somewhat bizarre but highly gratifying is that I possibly find more inspiration from meetings like this than from scientific meetings where I’m reasonably familiar with much of the material being discussed.  I suspect it’s something to do with being forced to think differently and more imaginatively about things, and having to approach issues from very different perspectives.

This is probably one added value of NISE Net that isn’t sufficiently recognized.  But it’s a tremendously important one.  NISE Net has developed an innovative process to introduce nanoscale science and engineering to people through science museums and other informal science education venues.  But that process is also educating the “educators”.

So I’m extremely grateful to everyone at the meeting who helped me see the world, and the issues I grapple with, in new ways.

Thank you NISE Net!

Of course, the downside is going to be a whole new string of blogs revolving around nanoscale science and engineering.

Sorry!

PS – there’s still time to vote on the Spider-Goat-Milk story I posted the other day.  This is directly related to the NISE Net meeting – a link that I’ll reveal as soon as enough people have contributed to the poll!

New technologies depend on uncommon materials, and society depends on new technologies.  Which means that economies that develop the former and control the latter have something of an upper hand in today’s interconnected and technology-dependent world.

This has clearly not escaped the notice of the Chinese.  China, which controls around 90% of the world’s rare earth minerals – many of which are essential to advanced materials – has being blocking shipments of these materials to Japan for the last month. And now, according to yesterday’s New York Times, it has “quietly halted some shipments of those materials to the United States and Europe”.

At the same time, according to the journal Nature,

“Alternative energy, biotechnology, advanced materials and fuel-efficient vehicles will be promoted in China’s newly mapped 2011–15 development plan, according to a report published by the country’s state council on 18 October.”

In other words, China is simultaneously controlling the flow of materials that are essential to many new technologies, while actively working on the very technologies that exploit these materials.

Rare earth elements aren’t that rare, despite the name.  But in recent years, it has become increasingly unprofitable for economies outside China to mine and process them.  As Technology Review noted a few days ago:

“Rare earths are comprised of 17 elements, such as terbium, which is used to make green phosphors for flat-panel TVs, lasers, and high-efficiency fluorescent lamps. Neodymium is key to the permanent magnets used to make high-efficiency electric motors. Although well over 90 percent of the minerals are produced in China, they are found in many places around the world, and, in spite of their name, are actually abundant in the earth’s crust (the name is a hold-over from a 19^th-century convention). In recent years, low-cost Chinese production and environmental concerns have caused suppliers outside of China to shut down operations.”

One solution to the looming monopoly is to begin extraction processes elsewhere.  Another is to look for alternatives to these increasingly valuable resources.  As Tim Harper of Cientifica noted in a recent report:

“Through the use of nanotechnologies we can now start to develop processes that do not use rare resources, for example using carbon nanotubes and metallic nanoparticles in polymers to make them conducting rather than applying thin layers of indium tin oxide.”

There are difficulties to this approach, as Dexter Johnson at IEEE Spectrum noted.  But one way or another, China’s actions are shining a searing spotlight on some of the hidden dependencies of technology innovation, and some of the less obvious challenges to developing technology-based solutions to problems in what is becoming an increasingly resource-constrained world, no matter how you look at it.

]]> http://2020science.org/2010/10/20/limited-resources-and-emerging-technologies-china-does-the-math/feed/ 0 http://2020science.org/2010/10/13/nanotechnology-2-0-the-next-ten-years-of-nano-risk-research/ http://2020science.org/2010/10/13/nanotechnology-2-0-the-next-ten-years-of-nano-risk-research/#comments Wed, 13 Oct 2010 15:43:57 +0000 Andrew Maynard http://2020science.org/?p=3643

Sometime in the past couple of weeks – I’m not entirely sure when as accounts are conflicting – the World Technology Evaluation Center (WTEC) posted a draft of a new report examining the long-term impacts and research directions of nanotechnology.  The “Nano2″ study was supported by the National Science Foundation under the direction of Mike Roco, and included input from an impressive array of nano-experts from round the world.  What resulted was a 13 chapter behemoth of a report on the current state and next ten years of nanotechnology worldwide.

Having just started to look through the report (I was traveling when it was posted … I think) I can’t really comment on it’s overall relevance and authority.  But if the chapter dealing with environment, health and safety (EHS) issues is anything to go by, this is a report to take seriously…

The EHS chapter (chapter 4) is authored by twelve recognized experts in the field of nano-risks, and presents a comprehensive perspective on near-term research challenges and opportunities.  The chapter is far from perfect – as you would expect, it reflects the perspectives and interests of the authors – but then most reports of this type do.  It also contains some rather jangling statements. For instance on the first page the definition of “the environmental, health and safety (EHS) of nanomaterials” seems to miss out environmental impact beyond “animal health”.  And a rather outmoded focus on educating the public on page 25, where the authors state

“A key issue therefore is for academia, industry and government is to find appropriate mechanisms to reach consensus, and effectively communicate and educate the public on the beneficial implications of nanotechnology, the potential for risk, and what is being done to ensure safe implementation of the technology.”

Mmm, not quite what they are teaching in engagement 101 these days!

But this is a draft, and these and other questionable statements do not detract from the overall usefulness of the chapter.

In many ways, the chapter reflects challenges that have been raised before.  Many of the issues highlighted can be traced back to the 2006 commentary in Nature I co-authored on nanotechnology safety challenges, and a number of reports that preceded it.  So questions surrounding exposure monitoring, toxicity screening, predictive modeling, safety by design and taking a life cycle approach to emerging nanomaterials abound.  But many of these are unpacked and explored in a fresh and useful way in this document. There is also a very welcome tie-in to risk-governance [a topic near and dear to my heart, having just co-edited a forthcoming book on the subject], reflecting the need for integrative approaches to understanding and addressing the challenges presented by engineered nanomaterials.

That said, the report fails to break out of old ruts when it comes to identifying materials of concern.  The old chestnuts are there – carbon nanotubes, zinc oxide, titanium dioxide, nano-silver and the like.  But there’s little mention of the next wave of emerging nanomaterials – nanoscale cellulose for instance, or active nanomaterials.  Neither do prevalent but poorly studied engineered nanomaterials like platinum/palladium nanoparticles in auto catalysts get a look-in.  Granted that the document is only looking forward 10 years, but it would have been good to have seen more thought given to complex nanomaterials, and novel approaches to exploring whether they present emergent risks, and how to handle them.

That aside though, this chapter is a strong addition to the literature on nanomaterial risks, and how we need to start addressing them – from risk identification and assessment through to risk management, mitigation and avoidance.  The areas highlighted for further research/action aren’t comprehensive, but they are important.  These include:

• Developing validated nano-EHS screening methods and harmonized protocols that promote standardized engineered nanomaterials risk assessment at levels commensurate with the growth of nanotechnology.
• Developing risk reduction strategies that can be implemented incrementally through commercial nanoproduct data collection, regulatory activity, and EHS research directly linked to decision-making.
• Developing a clearly defined strategy for nano-EHS governance that is compatible with incremental knowledge generation and stepwise decision-making
• Developing computational analysis methods capable of providing in silico modeling of nano-EHS risk assessment and modeling.
• Developing high-throughput and high-content screening as a universal tool for studying nanomaterial toxicology, ranking hazards, prioritizing animal studies and nano-Quantitative Structure Activity Relationship models, and guiding the safe design of nanomaterials.
• Improving safety screening and safe design of nanomaterials used in therapeutics and diagnostics.
• Developing advanced instrumentation and analytical methods for more competent and reliable engineered nanomaterial characterization, and detection in complex biological and environmental media.
• Development of computational models, algorithms, and multidisciplinary resources for increasingly sophisticated predictive modeling.
• Developing workforce capacity through interdisciplinary education and training, particularly in the nano-EHS field, where a large number of research areas are converging.

If you have an interest in nanotechnology impacts, I would definitely put the chapter on your reading list.  If you are actively involved in the field – it’s a must-read.

I mentioned that this is a draft report, and it’s actually open for public comment – you can sign up to comment here.  But you’d better be fast – just as there is some ambiguity over when the draft was posted, there is also ambiguity over when the comment period closes.  One source suggests it could be the end of this week – but I couldn’t find any confirmation of that.  So the sooner you get reading and commenting, the better!

A guest blog by John Dorr, Vice President of Business Development Nanocomp Technologies Inc.

Despite all the fuss over nanotechnology, it’s surprisingly difficult to get a clear sense of how the technology is contributing to new products.  So when the company Nanocomp Technologies Inc. approached me with an idea of writing a guest blog about what they are doing with carbon nanotubes, I jumped at the chance.  I’ve been aware of Nanocomp’s business for some time now and know the company’s President and CEO Peter Antionette, and have been both impressed and intrigued by their use of carbon nanotube sheets and yarns.  At the same time, I didn’t want 2020 Science turning into an industry PR conduit.  So I agreed to the guest blog with one condition – that it stick to science and technology, and not turn into a corporate publicity piece.  As it turns out, John Dorr’s piece is about as far from the hype that often accompanies nanotech stories as you can get. At the same time, this is clearly a significant and potentially important technology – one to watch I think.  Andrew Maynard

In the early 1990’s, a new form of carbon was discovered with highly unusual properties – it was strong, light, and conducted electricity and heat exceptionally well. Because the material was formed from incredibly thin tubes of carbon atoms, it rapidly became know as carbon nanotubes – or CNT for short.

Since their discovery, researchers and businesses have been working hard to exploit the unusual properties of carbon nanotubes – not as easy a task as many people initially thought. However, new and commercially viable uses for the material are now beginning to emerge.

Because of their shape and format, carbon nanotubes can be used in ways similar to other fibers.  As a result, carbon nanotube sheets, yarns and their derivative products are beginning to be introduced into the marketplace. The most productive and scalable manufacturing method in play today employs a gas phase pyrolysis  process for making very large format CNT non-woven textile sheets directly from the reactor without post processing.  As the process grows, a mesh of interconnected, millimeter length CNTs emerges as opposed to a loose powder of micron-scale CNTs. The result is a product that is fundamentally different from Bucky papers, which are made from short tubes that have been dispersed in solvent and subsequently membrane-filtered into film-like structures. They are similar in appearance only.

Figure 1. A 25-foot roll of double wall CNT material is shown being prepared for a customer.

One example of this difference is in mechanical performance. The mechanical strength of the raw, large format sheets is up to 1 GigaPascal (GPa) — five to twenty times better than buckypaper and in the class of m

etals and alloys. Moreover, their electrical conductivity–typically greater than 2 x 10⁶ Si/m–makes them ideal for replacing copper shielding in weight sensitive applications such as for aerospace.

It is also possible to impregnate rolls of these CNT sheets using commercial equipment with a wide variety of thermoset resins such as bismaleimide toughened epoxy (BMI). Figure 1 shows an example of a roll of these sheets.

In addition to sheet material, in a serendipitous blend of traditional and future industry, CNT yarns can be produced by harvesting carbon nanotubes from the reactor onto spools of finished spun material, much like traditional textile-like threads. These yarns can then be braided on commercial wire braiding machines to produce CNT wires of various gauge sizes, as is seen here:

Although the base CNT material is conductive, it can be post-processed to further increase conductivity using a very basic chemistry. This is particularly useful for applications requiring particularly high conductivity – including for application as a high performance, light weight electromagnetic interference (EMI) shield.

Figure 2. An example of four CNT panels seamed together. The people are shown for scale only!

Today, Nanocomp can fabricate sheets that are about four by eight feet long. The sheets can be easily seamed together into panels (see figure 2) or into rolls of any length desired. Such rolls are the standard form factor needed for pre-pregging or other types of resin infiltration, so the material can be easily integrated into such processes.

There are many applications for these materials generally focused on exploiting the unique electrical, thermal and mechanical properties of carbon nanotube sheets and yarns:

Electrical—applications include lightweight conductors, EMI shielding, ground planes and lightning protection, among others. The excellent shielding quality allows CNT material to be used as a substitute for copper braid in single- or multiple-conductor shielded cable. Weight savings from this step alone may range from 30 to 50 percent as compared to conventional materials. Another application is to replace copper conductors at very high frequencies, where the conductivity of CNT yarns can outperform copper.

Thermal—applications include heat straps, thermal interfaces for Integrated Circuit (IC) cooling and thermal interface materials. The thermal conductivity of individual carbon nanotubes can be very high, exceeding 40,000 Watts per Kelvin per meter (W/m-°K) at the nanoscale. Thermal conductivity at the macroscale, as seen in CNT sheets, is generally around 60 W/m-°K). As a comparison, copper has a thermal conductivity of around 400 W/m-°K. However, CNT sheets have a density of 0.5 g/cc while copper has a density of almost 9. On a weight-for-weight basis the CNT sheets have 3.5 times better thermal conductivity than the metal. The material also acts like a black body at wavelengths in the near-UV to the long IR, meaning that strips of the material can be used very effectively as Joule heaters at very high specific power.

Mechanical—potential applications include hybridized vehicular and body armor solutions as well as structural composites for a wide range of applications.  The lightness and strength of carbon nanotubes makes them particularly attractive for forming lightweight yet strong materials, and the carbon nanotube sheets produced by Nanocomp are particularly versatile in this respect.  Preliminary work in armor has focused on the use of the Company’s CNT sheets in thin, lightweight composites capable of stopping civilian handgun threats while maintaining durability and flexibility. While Nanocomp continues to improve the mechanical properties of our materials, we have achieved tensile strength values ranging from 1.1 – 3.5 GPa with CNT yarn, which compares favorably with Kevlar® and its published value of 2.9 GPa whether in sheet format or as yarn that can be subsequently woven into a hybrid fabric.

As with any advanced material, safety is an obvious concern when creating carbon nanotubes.  As mentioned previously, most CNT manufacturers develop products as a powder of short tubes. They can become easily airborne and pose an inhalation hazard.  Nanocomp does not produce material in this form, in fact it does not produce short CNTs at all.  Instead, its reactors produce sheet and yarn articles into which the company’s long CNTs have been inexorably bound, a property that has been borne out by rigorous testing done in partnership with leading government and academic labs. The sheets and yarn articles do not release nanomaterial under typical industrial processing, handling, and storage, and it is the conclusion of outside authorities that the company’s CNTs are simply too big to become airborne or be respirable.

John Dorr is Vice President of Business Development at Nanocomp Technologies, a manufacturer of CNT sheet and yarn materials and value-added products. Nanocomp is one of the only companies to efficiently manufacture and fill customer-ready orders for such carbon nanotube products, and widescale adoption of the material is really quite feasible. The company is set to expand its manufacturing capabilities within the coming year, in response to growing government and commercial market demand. To learn more see: http://www.nanocomptech.com/

[2020 Science has no commercial involvement with Nanocomp, and did not receive any form of financial support for this guest blog.  And as you would expect, the views expressed here are Nanocomp's, and not necessarily mine - just wanted to make that clear   Andrew Maynard]

I couldn’t resist finishing the August in the Archives series with this piece on “silent rave” syndrome, which I am sad to say still seems to inflict the emerging technologies community!

Originally posted October 5 2008

The silent rave might seem a rather bizarre social phenomenon; a group of strangers converging in a public place and dancing to their own individual iPod soundtracks.  But I have a sneaking suspicion that the emerging technology community has been indulging in the new tech-equivalent of silent raves for some time now.

These suspicions are probably the delusional by-product of jetlag.  But traveling back from the latest in a long line of multi-stakeholder nanotechnology meetings last week, the analogy hit a chord…

Imagine a meeting room where people are plugged into their own personal mental iPods: The scientists immersed in Avril Lavigne’s “Complicated” (apart from the toxicologists, who are playing “Another One Bites the Dust”); the industry folk tuned in to “I Did It My Way”; with the NGO’s rocking along to “Holding Out for a Hero” (with either Bonnie Tyler or Jennifer Saunders taking the lead, depending on how “hip” the group is).  And all the while the policy makers in the room listening to Bob Geldof and “I Don’t Like Mondays”—over and over again…

This is a recipe for a great time (for some), little progress, and a lot of noise.  And it seems to be one that is followed at many meetings designed to address the broader social, health and environmental issues of emerging technologies.

The problem is twofold I suspect:  People in different discipline and with different agendas find it hard to listen to and understand other perspectives. And in the absence of a clear focus for dialogue, it is near-impossible to find a common language to facilitate communication.  In the silent rave analogy: People find it really hard to unplug their mental iPods and listen to other tunes; especially if there isn’t a strong communal tune to replace their personal soundtracks.

This is hardly a blinding revelation.  But the point is nevertheless an important one if real progress is to be made in developing sustainable emerging technologies.  The question is: how can people be encouraged to unplug and join the conversation?

I’m not sure what the answer is, but I’m pretty sure one of the first steps will be to find that clear focus for dialogue—not just a woolly desire to talk about ill-defined implications of emerging technologies, but a clear statement of what the challenges are to making progress.  And that might mean dropping pre-conceived ideas of what defines any particular emerging technology (like nanotechnology), and focusing instead on what the science is revealing—and how this challenges conventional approaches to ensuring safe, environmentally sound and socially acceptable use.  Perhaps if this focus is found, it will lead to a communal tune so irresistible that people will start turning off their mental iPods, and tuning in to the group conversation.

In fairness, the meeting that sparked off these thoughts was more productive than many I have participated in.  But more is needed if we (as stakeholders in getting emerging technologies right) are to stop going round in circles and start making some serious headway into a technologically secure future.

And as for what is playing on my mental iPod:  Fortunately, I unplugged myself a long time back.  Funny thing though, no matter which meeting I’m at, I keep hearing strains of Pink Floyd’s “Is There Anybody  Out There?” Strange that!

______

The full August in the Archives 2010 series can be browsed here

The more the debate over what precisely nanotechnology is goes on, the more inclined I am to think that it’s something of an illusion.  Sure, nanoscale science is real.  And there are clearly technologies that exploit this.  But are they nanotechnologies, or are they simply clever uses of science, technology and engineering across multiple length scales to do something different?  In other words, does nanoscale science simply lead to… technology?  This piece from September 2008 hints at this line of thinking as it grapples with what “nanotechnology” actually means.

Originally posted September 3 2008.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

______

The full August in the Archives 2010 series can be browsed here

Most manufacturers of nanomaterial-based sunscreens try to make sure that the material they use doesn’t generate harmful chemicals in the presence of sunlight.  But the paper this piece was based on suggested that some photoactive materials might be slipping through the net.

Originally posted June 21 2008.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

But perhaps the biggest question here is one of regulation.  In the US, the Food and Drug Administration does not currently discriminate between anatase and rutile titanium dioxide particles in sunscreens, or doped and un-doped particles [Sunscreen Drug Products For Over-The-Counter Human Use: Final Monograph.  May 21 1999.  PDF, 424 KB].  But in the meantime, what is to stop manufacturers using potentially harmful forms of titanium dioxide in sunscreens?  And how will consumers be able to distinguish between companies that have got it right, and those that have not?

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

______

The full August in the Archives 2010 series can be browsed here

Even though it was written a couple of years ago, this post remains very relevant as people continue to make sense of nanotechnology.  Maybe it’s time to revisit yellow-technology!

Originally posted May 17 2008.

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

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

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

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

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

[long pause]

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

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

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

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

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

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

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

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

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

______

The full August in the Archives 2010 series can be browsed here

I couldn’t resist reposting this piece, as it captured so well my frustration at the time of spending so much time in meetings – usually for someone else’s benefit.  Sadly, I didn’t learn the error of my ways – my travel schedule has, if anything, got worse since then!

Originally posted May 8 2008.

My worst nightmare—I’m sitting at the back of a small plane (by the bathroom), my knees up round my ears (because someone else with a bigger case got to the overhead storage before me), and a small child screaming its head off two rows down.  But unlike a nightmare, this is reality, and waking up to a better life is not an option!  What did I do to deserve this?  The polite answer—agree to speak at yet another nano-meeting!

Don’t get me wrong, I realize that for most people these events are a welcome break from everyday routine; a chance to catch up with old colleagues, and possibly even learn something new.  But spare a thought for those of us for whom the “nano-meeting” has become an unfortunate way of life!

By my calculation, this will be the fifty-fourth nano-meeting I have spoken at or participated in over the last twelve months.  I think that puts me in the addict category!  Having shared the platform with some esteemed colleagues—again and again and again—I could probably give their talks off pat, as they could probably give mine.  And the really worrying thing—many of these traveling partners have tougher schedules than me.

As I sit here in my cramped seat; twisted most unnaturally in order to type on my laptop’s keyboard, I find myself asking: is the toll this incessant travel is taking on my health, my family and my by-now non-existent social life, the real “risk” of nanotechnology?  And is the nano-meeting-carbon-footprint threatening to overshadow all other environmental impacts?  And I must confess, the answer that comes back to me in my admittedly stressed state ismost assuredly yes!

So here’s my plan:  I am going to call for a moratorium on nano-meetings—just until we know more about the “risks.”  I thought about a voluntary program, with the slogan “just say no to nano-meetings”, and a network of self-help groups for recovering nano-meeting addicts.  But I know the temptation to do just one more meeting would be too strong.  The only solution is legislative action—and soon!

Bliss!  No more working nights and weekends to get ready for the next lecture.  No more burning the midnight oil to answer the day’s cascade of emails.  No more shifting in my seat every thirty seconds as the next incontinent passenger squeezes past to reach the bathroom.  Of course, it might make it kind of difficult to inform, educate and engage people on nanotechnology.  But hey—right now, I’m willing to pay that price.

Later…

Well, having landed and tracked down the obligatory Starbucks, I can feel sanity returning.  These meetings are tough and, contrary to what some think, most of us on the circuit attend them to be of service, rather than to indulge ourselves.  They do hit hard on our families, our jobs and our time.  But I think that most of us feel the effort is worthwhile, if the end result is informed discussion and action on developing nanotechnologies responsibly—as long as we don’t end up substituting meetings for action.  And they do have their compensations…  the leopard-print bath robe I’ve just discovered in my nautically-themed hotel room makes the whole enterprise seem that much more worth while.

Postscript

This was written several months back at a particularly low point on the nano-meeting circuit.  I still travel too much and spend too little time at home—as I write, I am looking out over a cloud-flecked North America from 30,000 feet.  So much for good intentions!  Maybe I’ll decline the next invitation.  Maybe…

______

The full August in the Archives 2010 series can be browsed here

This was based on a piece I originally wrote for Nano Today – the blog was a slightly extended version of what was published.  Although it was written two years ago, it’s still surprising how few people realize that breathing in nanoparticles is an everyday fact of life, and that to make sense of new risks from engineered nanoparticles, we need to understand what we are already experiencing.

Originally posted April 5 2008

Read some accounts of nanotechnology risks, and you might be forgiven for concluding that a single engineered nanoparticle can kill you.  Of course, a little critical thinking soon dispels this notion—we are constantly bombarded with incidental nanoparticles from sources that include cars, incinerators and fires; we have been since birth.  And as critics of “risk extremists” often point out, we seem to be doing just fine in this nano-rich environment.  But does this mean that the potential risks associated with engineered nanoparticles are little more than a myth?

This was the question I faced while writing an opinions piece for the latest issue of Nano Today.  It’s a question that’s constantly popping up, either because someone has forgotten (or never realized) that nanoparticle exposure is a fact of life, or as a justification for not worrying about the engineered varieties of nanoparticles.

As you might expect, the truth is somewhat more complex than either of these extremes, and still remains unclear.  But to get back to the article; as an “ambience-hack” (the literary equivalent of a “character actor”), I felt it important to start off in a place particularly laden with nanoparticles—my local coffee shop.  Armed with a model 3007 portable condensation particle counter, kindly on loan from TSI Incorporated, I resolutely set out to sample the local nano-aerosols over a good cappuccino.

As coffee and breakfast were being prepared, the particle counter indicated I was inhaling somewhere around four billion particles per minute.  That’s not far off one nanoparticle for every man, woman and child on the planet entering my lungs every sixty seconds.  Yet I was feeling fine.  Clearly my body was doing a good job of handling them—thanks to millennia of Darwinian natural selection giving me lungs that know a thing or two about airborne nanoparticles.

But I don’t buy into the idea that my surviving the coffee shop naturally means all nanoparticles are safe. The trouble is; all nanoparticles are not created equal, and to generalize will be to make mistakes—perhaps costly ones.

And the idea that we are perfectly adapted to breathing in particles is somewhat flawed. Consider these rather sobering facts associated with inhaling particles having a range of sizes: Between 1990 and 1999, there were over 30,000 deaths in the U.S. associated with occupational exposure to airborne materials [1]. Estimates of worldwide deaths from asbestos exposure lie between 250,000 and 400,000; and in the U.K., deaths due to asbestos-related mesothelioma are not expected to peak for another ten years—despite imports and use of asbestos peaking in the 1960’s [2].  In the general environment, estimates of the number of people who died from inhaling particles in the London Smog of 1952 are as high as 12,000 [3]. At a more subtle level, exposure to fine airborne particles has been associated with an elevated likelihood of dying, and there is increasing evidence linking nanoscale particle exposure with impacts on the cardiovascular system [4].

The bottom line is that our lungs, incredible as they are at dealing with each day’s dust burden, have their limitations. Our knowledge of airborne particles in general and incidental nanoparticles in particular can illuminate our approaches to engineered nanoparticles.  But just as the health risks from asbestos, vehicle emissions and welding fume differ, we will not be able to derive everything we need to know about engineered nanoparticles just by looking at the incidental varieties.

It’s interesting to push this idea of differences between particle types further.  Clearly our lungs have evolved to handle naturally occurring nanoparticles.  But does this mean we also have the ability to deal with engineered nanoparticles never previously encountered, and as a species have not had the chance to acclimatize to?  We know that our bodies have a hard time dealing with chemicals that do not occur naturally—will the same hold true for engineered nanomaterials?

And then there is the comparison between the veritable cocktail of ambient nanoparticles we all breathe, and the precision of many engineered nanoparticles. Does exposure to a complex mixture of particles cause harm through synergistic interactions, or does the “soup” we breathe dilute the impact of the relatively few dangerous particles that might be present?  And—if a manufacturer hits on a particular combination of physical and chemical properties that is less than compatible with a long and healthy life—how much more dangerous is an aerosol of this “pure nanomaterial” than the nanoparticles you and I are breathing now?

This leads to the tricky issue of dose—how much material is needed to cause damage.  “The dose makes the poison” is the mantra of toxicologists worldwide—acknowledging that the most toxic substances can be harmless (or even beneficial) at low enough doses, while nothing is good for you in excess.  Four billion particles per minute might sound like a lot, but it is a minuscule amount of material when you consider how much mass there probably is in those particles.  Scribbling out some rather crude back-of-the-envelope calculations, I am probably inhaling no more than 50 nanograms of nanoparticles per minute in the coffee shop.  In contrast, a highly toxic dust like crystalline silica has an occupational exposure limit that equates to inhaling around 1,000 nanograms per minute over eight hours, and the equivalent limit for a material like titanium dioxide is a whopping 300,000 nanograms per minute.  Yet which is the appropriate way to measure dose—the mass of particles, their number, or something else; like surface area?

At the end of the day, I can drink my coffee and inhale the local nanoparticles with no obvious ill effects because I’m not exposed for that long and my body knows how to deal with them.  And there are probably plenty of engineered nanomaterials I could do the same with.  I know that a single nanoparticle won’t kill me—probably a few billion wouldn’t be enough to do much damage.  But I’m under no illusion that all engineered nanoparticles will be safe, just because I’m breathing in incidental nanoparticles all the time.  It all comes down to understanding what causes a new material to be harmful, and how to avoid harm—which means we need to get on and do more research if questions like the ones above are going to be answered.

Now, back to my four billion particles a minute with a cappuccino on the side…

______

The full August in the Archives 2010 series can be browsed here

ASME – the organization that used to be known as the American Society of Mechanical Engineers – has just launched a series of educational podcasts on nanotechnology that are well worth checking out.

Between now and next February, the ASME Nanotechnology Institute will be posting new video and/or audio podcasts on their website every couple of weeks, covering a wide range of nanotechnology topics.

The podcasts are free, but you need to register with the site first before you can access them at http://nano.asme.org/Nano_Educational_Series.cfm However, to give you a feel for series, here’s the introductory video:

You may recognize one of the presenters   I spent a grueling four hours filming with ASME last year for the series – so it’s good to see I don’t look too worn out and exhausted in the video.

I’m not sure where else I will be appearing in the series – we covered a huge range of topics during filming – but expect to see at least one podcast with me addressing some of the environmental and human health aspects of nanotechnology.

Overall, this looks like a well-produced and informative series of podcasts, that should be well worth following if you have an interest in nanoscience and nanotechnology.

Following up from my previous post, here’s an open question to Friends of the Earth:

What is your worst case estimate of the human health risk from titanium dioxide and/or zinc oxide nanoparticles in sunscreens?

What I am interested in is a number – a probability of a specific human health impact being caused by using a given amount of nano-sunscreen over a certain amount of time.  Something like:

“In the worst case, it is estimated that using [number] grams per day of sunscreen comprising [percent] TiO2/ZnO nanoparticles over [number] days could lead to an [percent] risk of the user developing [disease].”

This can be based on an extrapolation of the current state of the science to a worst case scenario.  But it must be plausible.  And the calculations/sources to get to the end number must be transparent.

I’m asking because I am interested to see whether it is possible to place an upper bound on the safety of nanoparticle-based sunscreens, and whether this will be useful in moving the dialogue over nano-enabled sunscreens away from ungrounded speculation, towards evidence-based discussion.

So that’s the challenge.  I’m hoping my good friends at Friends of the Earth will rise to it.

Friends of the Earth (FoE) do not like nanoparticle-based sunscreens.  This has been evident for some years – back in 2006 the organization published the report Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks, and every year since then they have had something to say on the subject.

This year’s web-based piece leaves now doubt about FoE’s stance on nanotechnology-enabled sunscreens.  The recently posted article starts:

While you’re planning your summer vacation and thinking about what to pack, don’t forget the sunscreen — but make sure it doesn’t have manufactured nanoparticles in it!

But what is the reasoning behind this stance?  Helpfully, FoE have also posted six cases of what they describe as evidence “of risks from manufactured nanomaterials in sunscreen.”

As these are evidence-based statements, I thought it would be worth while going through them, and taking a look at the evidence they are based on:

FoE: “Manufactured nanomaterials used in sunscreens (such as zinc oxide and titanium oxide) can Damage human colon cells: A study from the University of Utah showed that nano zinc oxide is toxic to colon cells even in small amounts. The scientists called for more research and warned that the evidence is especially concerning for children who are more likely to accidently ingest sunscreen. The colon is vital because it eliminates food waste and absorbs important nutrients.”

This was a study that looked at interactions between zinc oxide (ZnO) particles and cells derived from the human colon, and was carried out in vitro (i.e. in a cell culture rather than in animals or people).  It did indeed indicate that nanometer scale ZnO particles were around twice as potent as larger ZnO particles in their ability to kill these cells under idealized conditions.  But the research also emphasized that direct contact with the cells was needed for a nanoscale particle-related effect.  In fact, the title of the paper was “ZnO Particulate Matter Requires Cell Contact for Toxicity in Human Colon Cancer Cells,” emphasizing this point above the higher potency of the more finely structured particles.

The research was interesting, but did not resolve whether zinc oxide particles could survive long enough in the gut to come into contact with cells lining the colon, whether interactions like those observed in the laboratory are plausible under real-world conditions, and what levels of exposure would be needed to cause significant harm.  The research also indicated that larger particles of zinc oxide – similar to particles that have been used in sunscreens and other topical creams for decades – were toxic to cells under the conditions of the study.

FoE: “Manufactured nanomaterials used in sunscreens (such as zinc oxide and titanium oxide) can Damage brain stem cells in mice: A study from China found that zinc oxide nanoparticles can damage the brains of mice by killing important brain stem cells. In another study, Japanese scientists injected pregnant mice with nano titanium dioxide and recorded changes in gene expression in the brains of their fetuses. These changes have been associated with autistic disorders, epilepsy and Alzheimer’s disease. Though more studies are necessary to know if this damage to would occur in humans, these studies with mice serve as important warnings. Such studies have encouraged scientists in the United Kingdom to explore the link between manufactured nanomaterials and Alzheimer’s disease. At the end of last summer, scientists at the University of Ulster were funded by the European Union to conduct more research.”

The China study was once again carried out using cell culture rather than in animals, and as a consequence the results are very hard to interpret.  What the researchers did find is that, under rather idealized conditions, it is possible to cause neural stem cells from mice to undergo apoptosis (controlled cell death) if they are exposed to enough zinc-containing material.  Importantly, the study did not indicate that cell death was associated with particle size – large particles, small particles and even dissolved Zinc all gave similar results.

The Japanese study on the other hand injected mice with extremely high concentrations of titanium dioxide (TiO2) particles – way, way higher than levels likely to get into people’s bloodstream.  Researchers saw qualitative changes in gene expression in fetuses and mice pups that are indicative of a number of disorders.  But – and this is important – there is no direct link between gene expression as measured in this study, and the onset of the neurological diseases mentioned above.  All this study indicates is that injecting TiO2 nanoparticles directly into the blood at extremely high levels causes brain cells in fetuses and pups to respond in some way.  Without knowing how those responses translate into disease (if they do at all), and what the relationship between dose and response is, this study does not provide information on the likelihood of TiO2 nanoparticles impacting the brain.

FoE: “Manufactured nanomaterials used in sunscreens (such as zinc oxide and titanium oxide) can Penetrate healthy adult skin: Isotope-labeled zinc used in nanosunscreens can potentially reach the blood stream and urine of humans, suggests an Australian study by Macquarie University’s Professor Brian Gulson. This study undermines claims that nanosunscreens will stay on the outer layers of dead skin.”

This study by Brian Gulson and colleagues has yet to be published, and so it is a little premature to draw conclusions from the findings.  However, from what has been discussed in the public sphere, the study does not show conclusively that manufactured nanoparticles used in sunscreens can penetrate healthy adult skin.  The study cleverly used sunscreens containing nanoparticles incorporating a stable isotope of zinc – one that is found naturally at very low concentrations.  This meant that, by applying the specially formulated sunscreens to volunteers and monitoring their blood and urine, researchers could tell conclusively whether the zinc from the sunscreen was getting into the body.  What they could not tell was whether it was particles or dissolved zinc getting through the skin.  And as zinc oxide is soluble, there’s a high chance that the very low levels of sunscreen-related zinc that were found in body fluid samples were associated with the stuff dissolving, rather than the penetration of nanoparticles.

We’ll have to wait for the paper to be published before any firm conclusions can be drawn from this work.  But if dissolution is the dominant mechanism here, it suggests that sunscreens relying on larger ZnO particles (and, coincidentally, recommended by Friends of the Earth), may lead to just as much zinc getting into the body as those using nanoscale ZnO particles.

It should also be noted that the results of this study are specific to ZnO – they cannot be extrapolated to other materials, such as TiO2.

FoE: “Manufactured nanomaterials used in sunscreens (such as zinc oxide and titanium oxide) can Travel up the food chain from smaller to larger organisms: A study by researchers at Arizona State University, the Georgia Institute of Technology, and Tsinghua University in China found through a dietary experiment that Daphnia (a “water flea” that provides important nutrition for aquatic life) can transfer nano titanium dioxide to larger organisms (in this case Zebrafish). This study is of great concern because it shows that manufactured nanomaterials with toxic properties could end up in the animal food chain at large.”

This is very true for the material that was the subject of the cited study – nanoscale TiO2 – although the results do not necessarily hold for other nanoscale materials.  At the same time, the study showed that the higher organisms in this case – zebrafish – accumulated more nanoscale TiO2 directly than they did through eating the lower organism – daphnia.

Where nanoscale materials used in sunscreens go in the environment, where they accumulate, and the impact they have, are all important questions.  But without information on toxicity and amounts of material potentially transferred, it is hard to say whether the transfer of these materials up the food chain is significant or not.

FoE: “Manufactured nanomaterials used in sunscreens (such as zinc oxide and titanium oxide) can Damage important microbes in the environment: Scientists at the University of Toledo found that nano titanium dioxide inhibited the function of bacteria after just an hour of exposure. Manufactured nanomaterials from sunscreens can easily wash off of the body in the shower and end up in wastewater and the wider environment, which could affect microbes that are helpful to ecosystems and sewage treatment plants.”

The link here is to a report from a presentation at an American Chemical Society meeting in 2009.  The full peer reviewed paper can be found here.  The published research indicates that nanoscale TiO2 can compromise the integrity of some (not all) bacterial cell membranes at certain concentrations under certain (laboratory) conditions.  The consequences of this are unknown, and it certainly isn’t possible to extrapolate from the research what the environmental impacts of nanoscale TiO2 releases might be, or at what concentrations in the environment an impact is likely.  More importantly, the published work showed no impact of nanoscale ZnO on bacteria at the concentrations used. In other words, the research does not show that nanoscale zinc oxide can damage important microbes in the environment.

FoE: “Manufactured nanomaterials used in sunscreens (such as zinc oxide and titanium oxide) can Travel from mothers to unborn fetuses: Nanoparticles up to 240 nm in size can cross into human placentas, meaning that the toxicity of manufactured nanomaterials could extend across generations.”

This is an important study, as it shows that particles of a specific type injected into the bloodstream can potentially cross over the placental barrier and into the fetus.  The research was carried out using human placenta, but outside the body and under laboratory conditions.  The particles used were polystyrene particles.  And the research was aimed at working out how to get beneficial drugs to the fetus.  The authors of the work note that high exposures were used, and that transport fro the placenta may well be influenced by particle composition and surface coating.  They go so far as to say that the research cannot be generalized across different types of nanoparticles.  In fact, while polystyrene particles up to 240 nm were observed to cross over the placental barrier in this study, the authors point out that in another study using the same system, polyethylene glycol coated gold particles up to 30 nm in diameter were not able to cross the placenta.

Each of the studies cited above is scientifically interesting.  But none of them seem to provide clear evidence that TiO2 or ZnO nanoparticles in sunscreens present a plausible risk to human health.  In many cases, they are associated with very artificial test systems that shed light on the science of how nanoparticles behave under certain conditions, but are far removed from real world situations.  Specifically, the studies do not shed light on whether nanoparticles in sunscreens can get into the body (the weight of scientific evidence is that they cannot get through the skin), whether the body’s defense mechanisms deal effectively with any nanoparticles that do get through (the evidence is that they can), and how much stuff is needed in the body to cause disease (a number of these studies indicate rather large quantities of material are needed).

In other words, the science is far from compelling in indicating that nanoparticles in sunscreens are a bad thing.  In fact, the current state of the science suggests that nanoparticles in sunscreens stay on top of the skin rather than penetrating it, are an effective and long lasting barrier against Ultraviolet radiation from the sun if applied correctly, and avoid some of the health concerns associated with non-nano sunscreens.  This is probably why another environment group – the Environmental Working Group (EWG) – recently recommended a range of nanoparticle-based sunscreens.   In fact, in a recent review EWG stated

Our top-rated sunscreens all contain the minerals zinc or titanium. They are the right choice for people who are looking for the best UVA protection without any sunscreen chemical considered to be a potential hormone disruptor. None of the products contain oxybenzone or vitamin A and none are sprayed or powdered.

Part of the problem here is that there is a lot of speculation going on about the pros and cons of nanoscale TiO2 and ZnO in sunscreens, and not a lot of analytical thinking.  What would be really helpful is some numbers on how risky these products might be.  Of course, we don’t have the data to state conclusively what levels of nanoparticles in sunscreens are safe – and there is a compelling case for more research here.  But we should at least be able to guestimate the numbers for a worst case scenario, based on the current state of the science.

So here’s a question back to Friends of the Earth – based on the current state of the science, what number would you put on the risk to human health of using nanoparticle-based sunscreens under a plausible worst-case scenario?

I’ll reiterate this question in a follow-up blog.  But it strikes me that, if we can begin to get some numbers on the table – even if they are just rough estimates, we might be able to cut through some of the speculation here and open up a reasonable discussion on the safety or otherwise of nanotechnology-enabled sunscreens.

]]> http://2020science.org/2010/06/08/friends-of-the-earth-come-down-hard-on-nanotechnology-are-they-right/feed/ 11 http://2020science.org/2010/05/28/nano-dispersants-and-nano-hysteria-time-to-think-about-the-science-folks/ http://2020science.org/2010/05/28/nano-dispersants-and-nano-hysteria-time-to-think-about-the-science-folks/#comments Sat, 29 May 2010 00:19:00 +0000 Andrew Maynard http://2020science.org/?p=3250

Catching up with my email after a long day off the net, I see that a group of Non Government Organizations (NGOs) are urging EPA not to allow the use of an alleged nanotechnology-based dispersant in the Gulf of Mexico.  The letter from thirteen organizations was covered in a piece by Andrew Schneider on AOL Online earlier today – which had considerable pickup on the web from what I can tell.

Sadly, a combination of limited information from the company – Green Earth Technologies – and poor understanding by others – seems to have led to the situation being dominated by misunderstanding and misinformation.

Green Earth Technologies has been lobbying hard to get their product G-MARINE™ Fuel Spill Clean-UP! used in the Gulf of Mexico for some days now.  According to the company

G-MARINE Fuel Spill Clean-UP! is a unique blend of plant derived, water based and ultimate biodegradable ingredients specifically formulated to quickly emulsify and encapsulate fuel and oil spills. These plant derived ingredients are processed to form a colloidal micelle whose small particle size (1-4 nanometers) enables it to penetrate and breakdown long chain hydrocarbons bonds in oils and grease and holds them in a colloidal suspension when mixed with water. Once oil has been suspended in a nano-colloidal suspension, there is no reverse emulsion; the oil becomes water soluble allowing it to be consumed by resident bacteria in the water. This dispersant formula is protected by trade secrets pursuant to Occupational Safety and Health Agency (OSHA) Standard CFR-1910 1200. The ingredient list has been reviewed by the US EPA and contains no ingredients considered hazardous by OSHA.

Is seems to have been the “nano” in the above description – leading to the substance being dubbed a “nano-dispersant” – that has raised eyebrows.

The nano here is very small micelles – “particles” of molecules formed from molecules with one end that is attracted to water, and one which repels water.  I place particles in inverted commas as these really very small bubbles of one liquid in another – hardly like particles at all.  And like bubbles, they probably don’t last that long.

Reading the company’s Materials Safety Data Sheet (MSDS), it’s possible to get a good idea what is in the micelles – mainly natural oils, mild detergents and surfactants.  But the MSDS doesn’t go as far as being specific about the physical nature of the micelles.  This is not too surprising perhaps as micelles are commonly used in products, as well as occurring naturally.  They are also transient – they fall apart reasonably fast, just like bubbles.

Now to the letter from the NGOs.  It starts out

It has come to our attention that Green Earth Technologies (GET), Inc. is seeking approval from the EPA to disperse a large quantity of manufactured nanoparticles in the Gulf of Mexico, stating that the dispersal would remedy the oil spill recently suffered by the region. The for-profit company claiming to sell “totally green” products created from nanotechnology, wishes to scatter on land and in water its G- Marine Fuel Spill Clean-UP! (NANO Emulsion Technology) Oil Dispersant in areas affected by the BP rig collapse in the Gulf of Mexico.

The undersigned public-interest organizations respectfully urge the EPA to deny approval of this and similar projects that seek to release nanoscale chemicals or chemicals measuring less than 300 nanometers into the environment. In this case the company claims their product is composed of particles measuring 1-4nm. Manufactured nanoparticles have been shown to be toxic to humans, mammals, and aquatic life.

The argument made is that G-MARINE Fuel Spill Clean-UP! contains a nanoscale component, that nanoscale components have been shown to be toxic, therefore the dispersant should not be used.  The letter goes on to say:

We are not aware at this time of the exact nanoscale particles used in this ‘nano emulsion technology’ because this information is considered a trade secret by the company. Yet, we do know that most chemicals manufactured at the nanoscale hold unique and potentially toxic properties. While some new properties from the nanoscale may seem desirable, materials at this scale can also pose new toxicological risks. Nanoparticles have a very large surface area which typically results in greater chemical reactivity, biological activity and catalytic behavior compared to larger particles of the same chemical composition. Unfortunately, the greater chemical reactivity and bioavailability of nanomaterials may also result in greater toxicity of nanoparticles compared to the same unit of mass of larger particles. Other properties of manufactured nanomaterials that influence toxicity include: chemical composition, shape, surface structure, surface charge, catalytic behavior, extent of particle aggregation or disaggregation, and the presence or absence of other groups of chemicals attached to the nanomaterials.

Unfortunately, the letter falls into the all too common trap of mistaking a relatively unstable cluster of small molecules as a “nanoparticle,” and prejudicially tagging it with properties associated with very specific nanoparticles – many of which are unlikely to have any relevance here.

This is a serious mistake to make, as it undermines any science-based discussion of safety and risk by claiming the ingredient in question is something it is not, then inferring properties on it which it is unlikely to have.  And the danger here is that as soon as the science is taken out of the equation, the real likelihood of harm being caused becomes extremely difficult to address.

Then there is the AOL piece.

In the main, the piece is straight reporting of the situation – albeit with an emphasis on the nano-safety issue.  But one section in particular jumps out:

The report of the possible use of nano-dispersants has outraged Harbut, who heads the Environmental Cancer Initiative at Michigan’s Karmanos Cancer Institute.

“A decision to use nanoparticle-based dispersants in the gulf is less an engineering or environmental decision, but more a public health and individual patient care issue. As does asbestos, nanoparticles have been shown to cause an aggressive cancer called mesothelioma,” he said.

And like asbestos in its early usage, human health effects of exposure, ingestion or breathing of nanoparticles have been rarely observed, let alone studied.

“To dump tons of nanoparticles into the food and respiratory cycle in this manner is irresponsible,” Harbut told AOL News

Here, the conflation between nanoscale micelles, nanoparticles and mesothelioma is wrong and it is irresponsible.  Nanoparticles in general have not been shown to cause mesothelioma, neither is there any theory to suggest that they might – this is pie in the sky speculation.  Carbon nanotubes – a specific form of nanomaterial – might possibly be associated with the disease under some conditions, but this is still uncertain.  But carbon nanotubes are not what may would recognize as nanoparticles, and are certainly not the same as micelles.

Then there is the conflation between micelles and nanoparticles again.  Okay so technically a micelle might be likened to a nanoparticle – but in the same way a soap bubble might be likened to a soccer ball!

So where does this leave us?

The root of the problem here seems to have been Green Earth Technologies’ use of the term “nano” – if they had just talked about micelles, no red flags would have been raised and it’s unlikely that the NGO letter would have found its way to EPA.  This term clearly term led to some confusion amongst organizations sensitized to the word.

Nevertheless, it would be irresponsible to throw the safety concerns out simply because of a definitional technicality.

Nanoscale materials do raise new safety questions – including nanoscale micelles.  But often, these questions can be addressed to a reasonable degree.  I’m not going to defend the safety evaluations that have been made by Green Earth Technologies as I don’t have the data.  In fact the company possibly shoots itself in the foot by being rather optimistic about the safety of their product.  This appeared today in an open letter from the company for instance:

Does G-MARINE OSC-1809 Oil & Fuel Spill Clean-UP! have any adverse affects on humans / animals or the environment?

None whatsoever. G-MARINE OSC-1809 Oil & Fuel Spill Clean-UP! has shown absolutely no adverse effect on humans or animals. All of our Marine products are manufactured from ingredient LISTED ON THE EPA CLEAN INGREDIENTS (1) List. It has a zero OHSA hazard rating and in Lab Tests (2) it has been shown to have no adverse affects whatsoever to nose (inhalation), mouth (ingestion), ears, skin, or eyes. Even if the person is subjected to a concentrated overdose, there has been no noticeable adverse affect. The Micelles BECAUSE of the EXTREMELY SMALL SIZE do NOT persist in the environment and Bio-degrade into harmless elements in 10 days as per EPA guideline in the CLEAN INGREDIENTS list.

“None whatsoever” is a dangerous assertion to make on adverse effects, as it implies every possible test has been done, and every conceivable eventuality accounted for.  And people tend to be suspicious of such absolute statements – better to be honest and admit the bounds of current knowledge.  Yet it is reasonable to assume that small micelles made up of well-evaluated ingredients are unlikely to have long-term environmental impacts that go beyond that of these ingredients – mainly because the micelles will break up and release their constituent components reasonably rapidly.

Could they get to places where they can cause harm in the short term because of their size?  It’s possible – and I would hope that toxicity tests would at least indicate whether this is an issue.  But there is a danger of making up potential yet implausible harm scenarios here because of a misunderstanding of the differences between micelles and other forms of nanomaterials.

And this is perhaps the most important message to come out of this situation.  In the case of the Gulf oil spill, inaction is not an option – but informed action must be based on the best possible information rather than questionable speculation.  This places the onus on companies to get the safety testing on their products right, even if it means going above and beyond what they consider necessary (especially if they decide to use a loaded term like “nano”).  It means that regulators need to ready to move fast when questions like this are asked – delayed action or misinformed action both have the potential to lead to adverse consequences.  And it also means that organizations and individuals influencing the debate and the decisions made must make sure they get the science right – speculative fear can only be divisive.

Making wise choices on the dispersants used in the Gulf of Mexico is vitally important, and bad choices could have lasting consequences.  And it is right and proper that questions should be asked over the use of one product over another.  But if the spill is to be dealt with effectively, these choices must be science-informed – otherwise no-ones interests are served in the long run.

]]> http://2020science.org/2010/05/28/nano-dispersants-and-nano-hysteria-time-to-think-about-the-science-folks/feed/ 24 http://2020science.org/2010/05/04/public-participation-in-nanotechnology-should-we-care/ http://2020science.org/2010/05/04/public-participation-in-nanotechnology-should-we-care/#comments Tue, 04 May 2010 21:15:35 +0000 Barbara Herr Harthorn http://2020science.org/?p=3116

A guest blog by Barbara Herr Harthorn, Director of the Center for Nanotechnology in Society at the University of California Santa Barbara.

A couple of weeks back, my colleague David Guston wrote here about engaging the public on nanotechnology.   In his piece he gave an excellent overview of the US government’s activities – or relative lack of them – on public engagement in this area.  But I also felt that some questions on why we should encourage public participation in nanotechnology in the first place – and how the government should think about approaching this – were left unanswered.  So to continue where David left off, I would like to explore these questions a little further.

To start with, why do public deliberation on nanotechnology?  The simplest answers are because it’s the right thing to do, and because it’s a useful thing to do.

Let’s take those one at a time:

Public participation is the right thing to do

Public participation in nanotechnology is the right thing to do because it’s a legal mandate – incorporation of some element of public participation is a required element of the Congressional authorization for the National Nanotechnology Initiative (NNI). It also enables citizens to participate more fully in the democratic process.

The normative view is that within a democracy it is right and proper to have all affected parties involved in decisions that may affect them (Fiorino 1989). Such democratic values may indeed compete with technocratic values, but the “participatory turn” (Whitmarsh 2009) with its resultant legal basis for participation is now an established fact in many countries.

If you accept that potentially affected publics have a right to know, at least about risks, the issue of how to gain their ‘informed consent’ to those risks is a complex ethical matter because nanotechnology involves an entire class of technologies that span almost all industries, and the potentially affected include most of society. Public deliberation is one method for achieving informed consent in this upstream context, although a comprehensive public deliberation effort in the US would necessarily be extensive in scope given the potential ubiquity of distribution of nano materials, products, and waste.

Both Centers for Nanotechnology in Society (CNS) established by the National Science Foundation – David’s at Arizona State University (ASU) and the one I direct at the University of California Santa Barbara (UCSB) – have engaged in public deliberation exercises.  But efforts to date have been on a small scale—they’ve necessarily included a very limited number of participants, and have focused only on a limited subset of the spectrum of applications (CNS-UCSB’s 10 public deliberation workshops in 2007 and 2009 focused on nanotech energy/environment applications or health/enhancement applications; CNS-ASU’s 6 workshops in 2007 looked exclusively at human enhancement technologies). On-line deliberation and the linking of selective face-to-face deliberation results with comprehensive survey data for validating opinions and views in national samples offer some potential methods for future larger scale nano deliberations, as long as diverse publics are included. We are pursuing both strategies on a pilot basis at CNS-UCSB.

In terms of public participation in the NNI, fulfillment of the normative purpose would mean allocating sufficient resources to conduct a meaningful public deliberation effort that is iterative and involves both lay persons and scientists.  Even though this might take some resources away from technological R&D in the short term, this would be in the interest of creating “socially sustainable technologies” (i.e., development of nanotechnologies that will be good for society in the long term).

Public deliberation is a useful thing to do

In addition to the normative reasons cited above, public participation is potentially useful for both instrumental and substantive purposes (Fiorino 1989). Instrumental here means that public participation contributes to other goals – for example, building community support for local development; or creating a basis of trust that will sustain support in the event of risk events.  Substantive contributions refer to the actual knowledge and learning that can take place through deliberative processes, particularly the contribution of local knowledge to successful outcomes – for example, better understanding of more useful applications of multi-purpose devices.

There are two foundational resources that have laid the groundwork for the current state of knowledge about this, both of them publications based on National Research Council panels:

Understanding Risk: Informing Decisions in a Democratic Society (Stern and Fineberg 1996) made the case for how making risks understandable to the public and avoiding risk controversies and conflict involve far more than just translating scientific knowledge (e.g. risk assessment). In it, they set out the main framework for “analytic-deliberative” decision making as a process that includes both analysis and public deliberation, brings lay and scientific experts together in an iterative process that promotes co-learning not just for particular decisions, and, when done well, can lead to better outcomes in terms of a number of important criteria.

Much more recently, in Dec 2008 Dietz and Stern’s National Research Council volume Public Participation in Environmental Assessment and Decision Making, reported on a panel specifically convened to address questions of whether public participation in environmental decision making was beneficial to the process and outcomes or if, as some detractors have argued, involving lay people in complex technical decision making slowed or even derailed the process. They concluded that when conducted properly, public participation as a part of government or private sector organizations for assessment, planning and decision making (i.e., not political participation for voting or forming interest groups) contributes to the quality, legitimacy and capacity of decision making.

Getting back to nanotechnology, the NNI has not yet specified the form that public participation should take.

Key aspects of successful public participation and deliberation have been shown to include:

• “early and often” (meaning that you need to begin the process early in development and continue interaction often);
• procedural fairness (even if publics don’t agree with agencies, if they feel they’ve been treated openly, respectfully and fairly, this leads to demonstrably better outcomes, such as less litigation) (Chess and Purcell 1999);
• well managed process, including a clear purpose, adequate resources, genuine commitment of participants to the process, timely outputs, and a focus on learning; and
• implementation that includes breadth of participants, intensity of interaction (particularly face-to-face), and integration of scientific expertise (Dietz & Stern 2008).

Thus, in addition to the political will to include participation as an element of the NNI, there is considerable basis for asserting that public participation in nanotech R&D can be beneficial to the quality, legitimacy and capacity of the NNI. Public participation in nanotechnology development that:

1. addresses needs and concerns of publics (and publics for this purpose would include businesses, NGOs, and communities, as well as individuals),
2. reduces mistrust between stakeholders (e.g., academic or industry labs and surrounding communities), and
3. results in all participants (including scientists) being better informed about the issues and about one another, and produces meta-learning about participatory processes

would be a highly successful outcome for the NNI. On the other hand, one enduring and detrimental feature of public participation efforts has been the “reluctance of government to grant influence to participatory efforts,” and another common cause of poor public participation outcomes is when participation is aimed at “boosterism” for an agency or program (Chess and Purcell 1999).

Clearly, public deliberation in the NNI, if it is to be effective, needs to take heed of these hard-won lessons, and knowledgeable researchers will be reluctant to take part in an effort that is likely to fail for such predictable reasons.

___________________________________

References

Chess, Caron and Kristen Purcell. 1999. Public participation and the environment: Do we know what works? Env Sci & Tech 33(16): 2685-2692.

Dietz, Thomas and Paul C. Stern, Eds. 2008. Public Participation in Environmental Assessment and Decision Making, Panel on Public Participation in Environmental Assessment and Decision Making, National Research Council. Washington: National Academies Press.

Fiorino, Daniel. 1989. Environmental risks and democratic process: A critical review. Columbia Journal of Environmental Law 14:501-547.

Stern, Paul D. & Harvey V. Fineberg, Eds. 1996. Understanding Risk: Informing Decisions in a Democratic Society. Committee on Risk Characterization, commission on Behavioral and social Sciences and Education. National Research Council. Washington: National Academies Press.

Whitmarsh, Lorraine. 2009. Review of Dietz and Stern, Public Participation in Environmental Assessment and Decision Making. Environmental Science & Policy 12:1069-1072.

Marc Saner at Carleton University in Canada sent this timeline of key nanotech policy events to me the other day.  It’s probably the most comprehensive compilation of events influencing the development of nanotech policy in America, Europe and Australia I’ve seen to date – well worth taking a look at if you have any interest whatsoever in what happened when related to the oversight of nanotechnology and engineered nanomaterials.

It also includes hotlinks to web-based documents where they are available, making the timeline a great resource for tracking down elusive reports.

The timeline isn’t inclusive – I’m not sure capturing everything is humanly possible – but it’s pretty good.  It’s also a living document – if you have something you think should be there that isn’t, you can email in your updates.

Language is often seen as a barrier to communication.  But sometimes it provides a valuable buffer between hearing, understanding and responding, and allows unique perspectives that are often drowned out to be heard.

A few weeks ago, I was interviewed by Brazilian TV presenter Luís Fernando Silva Pinto for the TV Globo program Ciência & Tecnologia on nanotechnology’s broader social and scientific implications.  As you would expect, when the documentary came out this week in Brazil, my very English segments were surrounded by a sea of Portuguese.  And having had a very “proper” English upbringing (i.e. I’m appallingly bad with other languages), I was completely at sea when it came to understanding how my comments were being framed.

Looking for some enlightenment, I asked the Brazilian-born Portuguese journalist Andréia Azevedo Soares (currently on sabbatical at Imperial College in London) for some help in getting a sense of what was being said in the program.  What I got back was a wonderfully candid running commentary on her response to the documentary.

Andréia’s notes were never written to be published.  But I found them so interesting that I asked if I could post them here – and she very kindly agreed.  In watching the documentary, she approached it both as a journalist and as a consumer.  And as a result, her comments shed considerable insight on how the story is presented, and how she as a consumer and Brazilian responded to it.

But the real beauty of her notes is that, because the documentary was in Portuguese, I was privileged to see it from her perspective – without the preconceptions, assumptions and biases I would usually bring to such a piece.  Very much a case of the message being found in translation!

The documentary – Nanotecnologia nos alimentos – can be viewed here (Update: thanks to Andréia for letting me know how to embed it):

Watching it, Andréia wrote:

0.0 Luís Fernando Silva Pinto picks the example of warnings on the cigarettes packages to make a parallel with nanotechnologies & food. When you smoke, you are fully aware of the risks you are taking. But what about food? He says: “If there was anything in your food that could be bad for your health, would you like to know? We are entering into the world of nanotechnology.” I understand the point the was trying to make with the parallel between labeling in tobacco industry and nanotechnologies, but putting it at the very beginning made me a bit scared. My body associated the smell of cigarettes with food that can be bad for me, and my head noted that nanotechnologies may have a role in this story. I am not sure about the connection between tobacco/food labeling (“If there was anything in your food that could be bad for your health, would you like to know?”) and the discipline itself in a broad sense (“We are entering into the world of nanotechnology”). The world of nanotechnology is not only about smelly evil foods, is it?

01.00 – 02.20 Luís Fernando says nanotechnology is becoming more and more a part of our lives – shampoo, soap and even equipment like the “electronic tongue.” I loved it! I’m now curious to know more about the electronic tongue. This is truly exciting. A scientist explains that a special layer can protect fruit and make it last longer. Luís Fernando asks questions like: “is it safe?” Andrew answers by explaining the uncertainties in the field (you have a plaster on a finger!) [You noticed!  The result of mishandling another “cutting edge” technology! - AM]. Luís Fernando says that even though we haven’t all the answers now, information provided by science will help us to control of and make informed decisions on our food. (Curious how science appears here as a solution to solve problem created by nanotechnologies – it makes me think about soaps made of greasy materials that clean… grease). I’m feeling more relaxed now. There are solutions in the pipeline. Luís Fernando uses words like “discussion” an “informed decisions,” and I feel empowered as a citizen.

02.20 Footage from Embrapa, in São Paulo [Embrapa is a research center connected to the Brazilian Ministry of Agriculture, Livestock and Food Supply - AM]. They produce new equipment and solutions focused on nanotechnologies applied to the farming business. It is said that this is a unique research centre in the world. I don’t know their work and feel excited about the science being done in Brazil. The reporter Flávio Ventura explains that they receive ground coffee from all over the country and they evaluate the quality of the product. Gustavo de Paula, an engineer (materials), introduces us to the “electronic tongue” and explains how it works. I love it! He says there are nano structures in it that can “taste” the coffee.  They complement the work done by the human taster – one thing is not going to replace the other. Gustavo de Paula explains things very clearly, I think I want to visit Embrapa at some point!

04.50 Details are given on what exactly the nano scale is, how scientists can “see” it, what equipment is required. The reporter says: “We live in a nano world but we simply are not aware of it.” He says that the pollen of flowers has a nano-metric element. He adds: “The proteins that make our body, and the DNA itself, is nano as well”. Then appears the nano specialist Eduardo Caritá, overexcited, saying: “The DNA controls all life in the universe – it is something with [a scale of] 2 nanometers. Do you think nature would have chosen this scale, this form, this structure if it were not the more efficient?” He conveys a lot of information in a very well-packed sentence (TV reporters probably love him), but I’m very very picky with DNA metaphors and get quite annoyed here. DNA is an inert molecule, it doesn’t control anything. Mother nature doesn’t have intentions, she doesn’t choose anything – things evolve. *eyes rolling* I take a deep breath and try to think Brazil is a country with almost 200 millions people and that TV Globo is a mainstream channel – it is amazing having a specialist talking about molecular structures on TV in such a simple and enthusiastic way. Language also evolves according to its context. Ultimately, the objective is to communicate. He does that very well.

06.00 New products. Nano-capsules that release chocolate flavors. Humidifiers that release rejuvenating particles (allegedly). The reporter says a brilliant sentence: “The nano world is becoming less and less invisible.”

07.40 Back to Embrapa. Engineer Gustavo de Paula stresses that *any* technology can do good or harm. “Nanotechnology is no different. We need to understand it at great detail to control the possible risks it might offer.”

08.05 Back to Andrew Maynard! Luís Fernando says you are a physicist, have studied in Cambridge (UK), and specialised a decade ago in this field. He adds that since 2005 you have been an active voice on regulation. And here comes the interview bit… [Andréia declined comment on my bits! - AM]

10.10 Back to Embrapa, focusing on fresh fruit and the film using nano-particles that helps to protect them from oxidation. The Embrapa researcher Odílio Assis explain that in Brazil nearly 50% of fruit are wasted during transportation and storing processes. He claims that this technology would ensure that 80% to 90 % of the crops effectively reach the sellers/consumers. The reporter says that the researchers are already sure about the safety of this anti-aging film for fruit, but they will do further toxicology research on it anyway. The Embraba researcher explains that nanotechnology cannot be understood as a single technology, and mentions that the nature of different particles should be taken into account. In that sense, an organic nano particle is different from a metallic one, he says. At Embrapa, he adds, they deal with natural particles obtained from a corn protein – so there is nothing to fear about, he suggests.

INTERVAL

13.30 Back to Andrew. Luís Fernando says that the lack of information is the main problem now. He adds that you believe that further and serious research is needed. And then comes the interview bit (I like the pink lamp on the desk) [It’s not mine - it belongs to a colleague.  Honest! - AM].

15.00 Fiocruz scientist William Waissmann says that we don’t yet understand all the possible outcomes of nanotechnologies, and adds that a great deal of their impact in humans remains unknown. Waissmann says there is no regulation on this matter in Brazil. He tries to be optimistic nonetheless, underlining that there are good scientists beginning to work in the field.

16.30 Luís Fernando says you believe science is in a position to provide answers. However, he says, you believe further and better research is needed and, therefore,  the  researchcinvestment should be more generous (figures are mentioned). I really enjoy your comments, they make me alert and willing to engage in the debate but not too scared. This is important. Scared people don’t engage in debates – they scream (I do, at least).

18.00 Back to Waissmann (I like the way he conveys the message – he says Brazil is completely unprepared to face nanotechnologies issues and, still, I didn’t panic yet). He says that people form opinions not only by gathering information from scientific sources but mainly from their cultural context (friends, small talk, etc.). He says that not as a problem itself but as someone who is trying to understand reality to better cope/deal with it. It did not escape my notice that all interviewees have good communication skills – and as a Brazilian citizen, I’m happy about this.

18.30 Back to Andrew. The silver Tupperware bit. I realise that there are too many objects behind you, Andrew.  I should not be paying attention to pink lamps and US flags – please try to do an uncluttering operation before giving interviews. You are infinitely more interesting and appealing than an US flag, but absent-minded people like me can get distracted with these details. [I should add in my defense that Luís Fernando decided to film me at a colleagues desk - I don’t normally surround myself with pink lamps and American flags! - AM]

19.30 Back to Waissmann. He underlines the possible effects not only on human health but also on the environment (I love it when someone tries to show things in a less anthropocentric way). He also explains why the same material can act differently depending on its form – the example given is comparing refined salt to coarse sea salt. Why has the latter less “power” than the former? I like the example but I suspect it covers the surface/contact/reaction bit rather than the fact that at the nano-scales particles behave differently (e.g. gold). But I am not the expert – he is and you are. And for the program, the example works brilliantly. He says that, in terms of toxicology, it is a new world we are entering in.

20.50 Andrew again.

22.20 Wrapping up. Luís Fernando says that it is up to us, consumers, to make informed choices. Even though the program finishes leaving me surrounded by uncertainties, I feel fine about the challenges to come. I believe it is difficult to talk about food safety and, at the same time, to leave an optimistic note at the end. I am curious to know more about the electronic tongue. I want to discuss what I’ve learned here with my partner as it is him who’s in charge of the supermarket duties.

I am deeply indebted to Andréia for taking the time to do this, for her candid insight, and for he willingness to allow me to publish notes that were never written for publication – thank you!

__________________________________

Andréia Azevedo Soares blogs at Bordado Inglês – in Portuguese.  She can also be followed on Twitter, where she writes about science, literature  language and the media (amongst other things) – and often in English

Update 4/26/10:  Corrected a few typos (including spelling Andréia’s name wrong – slapped wrists and big apologies!), and embedded the Ciência & Tecnologia video.

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

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

Confused yet?  Let me try and explain.

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

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

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

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

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

AOL Story about Nanotech – Some Response Points

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

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

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

The quality’s a bit flaky, but I thought I would upload this video for a bit of fun.  It’s the first – and possibly the last – time I will simultaneously attempt to unravel the mysteries of nanotechnology… while baking a cake!

Filmed at the National Museum of American History as part of Nanodays 2010, the presentation was part of a public dialogue on  nanotechnology.  My task: help set the scene for a discussion on who should oversee the responsible development of nanotechnology.

Wanting to try something a little different, I thought I would play around with cooking as an analogy for nanotechnology.  The analogy is a useful one – I only scrape the surface of where it could be taken here.  But whether it was a wise decision to actually cook in public – well, I’ll leave judgment on that one to you!

One thing the video doesn’t show is how the cake turned out.  I would like to say that it was light, moist and delicious.  However, just in case someone posts pictures of the actual result, I have to be straight with you – it sucked!  Personally, I blame the lab oven provided by the Smithsonian – I can cook, honest!  Perhaps a bonus lesson though is that, even with the best preparations, unanticipated consequences are always possible – whether baking a cake or making the latest nanotech-enabled gizmo!

A guest blog by David H. Guston, Director of the Center for Nanotechnology in Society at Arizona State University.

The President’s Council of Advisors for Science and Technology (PCAST) has recently put the National Nanotechnology Initiative (NNI) through its biennial paces.  Launched in 2000 by President Clinton, authorized in 2003 by the 21^st Century Nanotechnology R&D Act, and reviewed in 2005 and 2008 by PCAST (yes, an odd vision of “biennial”), the NNI is now a decade old.  For better and for ill, it is starting to show its age.

First, full disclosure.  I direct a Nano-scale Science and Engineering Center (NSEC), funded by the National Science Foundation (NSF) under the NNI to investigate the societal aspects of nanotechnologies.  So my Center for Nanotechnology in Society at Arizona State University (CNS-ASU) gets a bit more than $1M per year from NNI.  Second, as can be seen in the recent PCAST review document [PDF, 4.8 MB], I also testified before the working group that produced the report.  Third, one of the PCAST members is my college roommate’s mother (but that’s *not* why I was called to testify!).

Whew!

Since the early days of NNI, as well as since the 2003 Act, public engagement with nanotechnology was supposed to be on the agenda.  The early reports by NSF on the societal aspects of nanotechnology refer to the productive role that public engagement can play, and the relevant passage from the 2003 Act 2(B)(10)(d) authorizes:

“public input and outreach to be integrated into the Program by the convening of regular and ongoing public discussions, through mechanisms such as citizens’ panels, consensus conferences, and educational events, as appropriate.”

Bluntly, however, public engagement has not been implemented as robustly as it might have been.

In May 2006, the NNI offered a promising if tardy start with a large workshop on public participation, organized by the National Nanotechnology Coordinating Office (NNCO) and sponsored by the Nano-scale Science, Engineering and Technology (NSET) Subcommittee.  The two-day program generated considerable excitement among the larger-than-expected number of attendees.  Yet, while the presentations from the workshop are available on line, no report on the workshop seems to have ever been finalized for distribution on the NNI website.

The major messages of that meeting, as well as almost all relevant scholarship in public engagement in science and technology over the last decade and a half, are that:

• Communication between the lay-public (which is not monolithic) and the scientific community (which isn’t, either) needs to be two-way.
• Such communication needs to be not just about scientific facts but also about technological applications and social values.
• And the purpose of this communication must not be limited to the faulty formula of “more knowledge on the part of the public will mean more support for research and technological applications.”

Nevertheless, the nanotechnocracy has generally cast public engagement in terms entirely instrumental for the success of, well, nanotechnology.

The first PCAST (2005:38) report [PDF, 4 MB], e.g. argued directly that:

“[t]o sustain this [high level of public] support, the scientific community and the Federal agencies that fund scientific research must communicate more directly with the public, not through surrogates such as the entertainment industry…. Through the NNI website and through outreach activities at the NSF-funded centers and DOE user facilities, the NNI has established channels to communicate with members of various stakeholder groups, including the broader public.”

Similarly, recommendation 6.1 of PCAST (2008:34-35) [PDF, 1.3 MB] was to:

“[d]emonstrate more clearly to the public the value of nanotechnology and NNI-supported research and development.”

The first report (PCAST 2005:38) even attempted a pre-emptive defense of its practices, reporting that its working group “has held open meetings focusing on nanotechnology issues, which have provided the public with several opportunities to provide input.”  But the ability of the general public – as opposed to organized and special interests – to participate substantively in “open meetings” of executive agency committees is highly constrained, which is likely why the passage in the 2003 Act cited above calls for open, interactive public forums like citizens’ panels and consensus conferences.

Taking guidance from this specific language, CNS-ASU has made public engagement a centerpiece of its activities.  In Spring 2008, CNS-ASU organized the most ambitious public engagement activity around nanotechnology in the US, the National Citizens’ Technology Forum (NCTF).  Modeled after the Danish consensus conference but distributed across six locales across the United States, the NCTF on “nanotechnologies and human enhancement” demonstrated that a high-quality deliberative activity can be organized at a national scale in the US, and that a representative selection of lay-citizens can come to discerning judgments about nanotechnologies while they are still emergent (Hamlett et al. 2008, PDF 184 KB).  While there are reasonable concerns about the quality of the particular online component of the process (Delborne et al. 2009, PDF, 160 KB) and the demands that such intensive activities place on citizens (Kleinman et al. 2009), the NCTF process is a sound demonstration upon which to build future citizen deliberations (Philbrick and Barandiaran 2009).

In other words, large-scale public engagement activities around nanotechnology are ready for prime time.  As we move into a next decade of large-scale funding and the first forays of regulation, it is time for the NNI to follow through on the early promise of its vision of public engagement in nanotechnology for the benefit of the public, and not just for the benefit of nanotechnology.

This week, the NNI is holding a workshop on Risk Management Methods & Ethical, Legal, and Societal Implications of Nanotechnology, which includes a 15 minute slot for public comment.  David Guston will not be there – the workshop clashes with Passover – AM

]]> http://2020science.org/2010/03/30/public-engagement-with-nanotechnology/feed/ 24 http://2020science.org/2010/03/18/the-uk-nanotechnologies-strategy-disappointing/ http://2020science.org/2010/03/18/the-uk-nanotechnologies-strategy-disappointing/#comments Thu, 18 Mar 2010 17:59:02 +0000 Andrew Maynard http://2020science.org/?p=2964

Ten years ago, President Clinton laid the foundation stone of the current global Nanotechnology Initiative.  In a speech given at at Caltech, he announced the formation of the US National Nanotechnology Initiative, and set a chain of events in motion that has led to economies and businesses around the world investing in the technology of the small.  A decade on, nanotechnology is a multi-billion dollar research and development enterprise, is touted as holding the promise of reviving economies, creating jobs and solving global challenges, and is already adding to the performance and value of innumerable products.

Against this backdrop, the UK Government has just released its first a new strategy for the successful and safe development of nanotechnology – or nanotechnologies to be precise. [See update for why this isn't the first strategy]

I was interested to read the strategy, having just finished helping to review the US National Nanotechnology Initiative for the President’s Council of Advisers on Science and Technology (the PCAST review of the NNI is due to be published shortly).  The UK has had a strong presence in the nanotechnology arena for some years, combined with a pragmatic approach to technology development. So I was expectant of a strong and sensible strategy that mapped out how the country planned to be a key player in the “next industrial revolution.”

Sadly, I was disappointed.

At the risk of boring readers, I’m going to include somewhat detailed comments on the strategy below.  But here are my headline reflections:

• Successful nanotechnologies need strategic investment in science. The strategy focuses on three key areas: exploiting nanotechnology breakthroughs commercially, addressing potential health, safety and environmental impacts, and regulating the technology and its products.  However, there is no specific emphasis on exploratory science. The implicit assumption is that the machinery of knowledge generation – funding for exploratory research, and the expertise to generate new knowledge – is in place.  But this is a very rash assumption indeed.  Without strategic investment in funding exploratory nanoscale science, especially at the interface between disciplines, the UK is likely to loose out to other countries that recognize the need to drive innovation through knowledge creation.  The US and China in particular are steaming ahead here – without a clear research strategy, the UK is destined to become marginalized.
• Innovation begets innovation. While the strategy addresses the commercial exploitation of nanotechnology in general terms, it stops short of considering how innovative new approaches can be used to get innovative new technologies to market – including alternative financing models, new ways of enabling technology transfer, and overcoming institutional barriers to change.
• Risk and regulation cannot drive an effective nanotechnologies strategy. I’m a strong advocate of dealing with the potential adverse impacts of nanotechnologies.  But developing a national nanotechnologies strategy that is two thirds-focused on understanding and addressing potential risks seems a little over the top, even to me!  Strategic risk-research and responsive oversight are absolutely essential to the safe and sustained development of nanotechnology-based products and processes.  But in the broader context, they should support the overall aims of improving quality of life, stimulating economic growth and providing jobs – not be the heart and soul of the whole enterprise.
• Nanotechnologies risk research isn’t just about reassuring people that products are safe. Despite a heavy emphasis on risk and regulation, the strategy seems to reflect a somewhat naive understanding of why research into potential risks, handling uncertainty and developing responsive oversight is important.  Repeatedly, the need to reassure “the public” that the products they buy are safe is highlighted as an important driver.  But how about the need of businesses to develop and market products responsibly?  Many businesses that have a culture (or are developing one ) of placing a high priority on producing safe and responsible products are desperate for better information on how to do this with nanotech-enabled products.  Yet it’s telling that the UK strategy has no clear link between environmental, health and safety research and business, industry and innovation.
• Strategies should be built on sound data. There are a number of places in the report where the data are suspect – especially in the section dealing with business, industry and innovation.  At the least, I would expect a Government-level report to get the facts right.  For instance, it is claimed that the UK is fourth in the world in terms of the number of nanotechnology patents applied for, after the US, Japan and Germany.  Yet the latest figures – published last year – show the UK ranking 11th in terms of the number of patents filed in the country (in 2008, 68 nanotechnology patents were filed in the UK, compared to 3,729 in the US and 5,030 in China.  That’s around 0.5% of all nanotechnology patents filed in 2008).  The report also estimates “the global market in nano-enabled products is expected to grow from $2.3 bn in 2007 to $81 bn in 2015,” yet the basis for these figures is not explained (they come from a report that will set you back $6,000 if you want to read it!).  These figures seem very low – especially compared to estimates of between $1 trillion and $3 trillion from other sources for the future worth of products based in some way on nanotechnology.  In effect, the UK Government figures are meaningless without further explanation.  And if they are correct, I have to wonder why governments and industry around the world are investing tens of billions of dollars in a technology that is only going to be worth… tens of billions of dollars!
• If you are going to form a Nanotechnology Research Strategy Group, make sure their scope extends beyond just addressing risks. I have to applaud the UK strategy for listing a sensible set of nanotechnology environmental, health and safety research priorities (Appendix A of the report).  But to make these THE research priorities of the Nanotechnology Research Strategy Group – that just send a message that the UK government is only interested in potential risks.  Changing the name of the group might be a good idea!
• Resist the temptation to include past activities as strategic actions. Call me a pedant, but I do find it frustrating where a strategy includes stuff that has already been done in its list of actions.  It smacks of padding things out, rather than looking forward to what needs to be done, and how.  Actions 3.3 – 3.6, just for example, refer to activities already underway – nothing particularly strategic about that!
• Don’t confuse toxicology with risk science.  There are three action points in the report (3.14 – 3.16) specifically aimed at developing the UK’s toxicology skills base.  This is good – it should be developed.  But so should expertise in exposure assessment, risk assessment, risk management, handling uncertainty and oversight.  Sadly, the strategy seems to assume that toxicology is the be-all and end-all of risk identification, assessment and management, whereas in reality it is only one component.
• If you are going to reach out to members of the public, take it seriously. In 2009 BIS supported what is possibly the best lay source of information on nanotechnologies – Nano & Me.  But rather than praising the initiative and supporting it, the UK strategy is rather less than luke-warm.  According to the strategy, the website has completed its 5 months (5 months?!) trial period, and will now be evaluated – that’s it.  This effort needs to be run longer – much longer.  It needs to be funded better.  And it needs to be promoted by the Government, not treated like an embarrassing relative.

So all in all, not a great strategy.  It’s not all bad – there are strengths in what the UK has done and intends to do in developing safe and successful nanotechnologies.  But as a strategy, this would have been flaky five years ago, and is now positively threadbare.

In a global climate where economies are eying one another up to see who’s going to take the lead in nanotechnology, I’m afraid the strategy sends a clear message – don’t worry about us!

__________________________________________

Some more specific observations

1. In the executive summary (p4), there is no mention of supporting research in nanoscience that will lead to innovation in nanotechnologies.
2. Nanotechnologies are described as being “at a very early stage in their development” (p6).  After a ten-year global push and many previous years’ research into nanoscale science, together with a wealth of nanotech-enabled products on the market, this is a dubious statement at best.
3. I’m wondering when we will see “more compact and powerful computer systems, mobile phones and wiring systems incorporating carbon nanotubes” (p6) – unless it’s just the wiring systems that will use the nanotubes.  Very unclear.
4. I’ve already questioned the projection of the global market in nano-enabled goods as $81 bn in 2015 above.
5. Apparently, the UK also has the third highest number of nanotechnologies companies in the world.  Wow!  Which countries are leading us – the US, China, Japan, Korea, Germany perhaps?  Take your pick – although I’m not sure how you will tell if you are correct, as no source was given for the claim.
6. A tricky point in any report like this is explaining what nanotechnologies are.  I’d love to know what others thought of the explanation in Box 1 (p6), which gets close to mixing and matching nanotechnologies, nanomaterials and nanoparticles.  I was confused!
7. I’ve already addressed the question of nanotechnology patents above.  Why the report didn’t cite Dang et al. I don’t know!
8. On page 7 the report states “At present, it is thought that the greatest level of risk may be posed by nanomaterials which are in the form of free particles, such as in a powder or liquid.”  This was a conclusion of the 2005 Royal Society/Royal Academy of Engineers report on nanotechnologies, and is still important.  But over the past five years, perspectives have developed and become a little more sophisticated, recognizing the need to consider how new materials might come into contact with and interact with people and the environment, rather than fixating on nanoparticles.
9. This I found interesting:  On page 9 it is stated that “Above all, it is Government’s role to protect health and the environment during the development and use of nanotechnologies.”  This possibly explains the emphasis on risk and regulation in the strategy.
10. Figure 1 in the report shows the linkages between the four different areas of the strategy.  But as mentioned above, there is no direct linkage between environmental, health and safety research, and business, industry and innovation.  I would argue that two-way links here are absolutely essential to responsible development.
11. Here’s a recurring theme in the strategy. On page 11 one challenge to the commercialization of nanotechnologies listed is “A need for industry to engage with the public in order to raise awareness of the benefits of nanotechnologies-based products, and to counter any negative perceptions or concerns” (emphasis added).  I’m sorry, this is not what public engagement is all about.  In fact, in the light of this, I’m embarrassed to have applauded the UK’s approaches to public engagement and science last week – clearly there are some communication disconnects between departments!
12. On page 15, in reading about a lack of critical mass amongst small nanotech businesses in the UK, and a lack of business leadership, I was wondering where the Nanotechnology Industry Alliance was… Surely these small businesses aren’t voiceless.
13. Page 21 lists some good research into nanotechnology environmental, health and safety issues carried out in the UK. Unless I have missed something, they are all associated with a group of researcher based in Edinburgh. Should this have been called the Scottish Nanotechnologies Strategy?
14. However, on the same page an important study into the the potential health impacts of long carbon nanotubes is credited to Ken Donaldson – Graig Poland, not Ken, was the lead author.  This sort of mistake should not occur in a report like this one!
15. I’ve already mentioned the strange name of the group established to focus on nanotechnology environmental, health and safety research above (p 22) – the Nanotechnologies Research Strategy Group.  Wonder if the UK has a shadow group looking at non-environmental, health and safety research.
16. I’ve also covered the emphasis on toxicology above, but this is so important that it’s worth mentioning again.  On page 26 the report states “A shortage of new toxicologists was identified in RCEP’s report in 2008 as a risk to the nanotechnologies field, as toxicology research is pivotal to the successful development of new materials and products.”  Looking over that RCEP report, it had a strong emphasis on toxicology which at the time was not out of place.  But the UK strategy seems to have taken one recommendation from that report and run with it, to the exclusion of every other aspect of risk identification, assessment and management.  I’m not sure what the opposite of a strategy is, but this would qualify in my books.  Strategic action towards developing safe and responsible nanotechnologies must address all aspects of risk – not just material hazard.
17. On page 27, the strategy sets out the four key areas where “nanomaterials are most likely to come into contact with humans, or the environment”: Food; Cosmetics; Healthcare devices and medicines; and Workplace health and safety.  These are all very reasonable.  But what about all the other strategic areas – products which might shed nanomaterials while being used; products that lead to inadvertent exposure; products that release nanomaterials when disposed of or recycled; products that children might chew on or ingest, and so on.  Restricting the strategy to these four areas seems, well, restrictive.
18. Following up on those medical devices and medicines, there’s no mention of the regulatory challenges presented by combination products – products that act as both a device and a medicine.  Maybe this isn’t an issue in the UK – it’s certainly one in the US.
19. When it comes to the workplace, I was intrigued to see that “there are no current plans for any specific guidance on risk management for materials other than carbon nanotubes.”  Why?  Businesses and researchers are desperate for clear guidance on working safely with nanomaterials, which is why organizations such as NIOSH, ICON and ISO have been so active in the area.  The good news is that, even if the UK government isn’t intending to provide useful information for working with nanomaterials in the immediate future, others are filling the gap.

Update, 3/18/10  When this piece was first posted, I mistakenly referred to the strategy as the UK’s first nanotechnology strategy – a perception that the report itself does nothing to dispel.  However, as Michael Kenward kindly pointed out in the comments, this is in fact the UK’s second nanotechnology strategy (as long as you don’t nit-pick over differences between “nanotechnology” and “nanotechnologies.”).  The original strategy – published in 2002 – is available here Strangely, the current strategy does not acknowledge the existence of its predecessor. [PDF, 422 KB].

]]> http://2020science.org/2010/03/18/the-uk-nanotechnologies-strategy-disappointing/feed/ 29 http://2020science.org/2010/03/18/uk-nanotech-strategy-unavailable-due-to-technical-difficulties/ http://2020science.org/2010/03/18/uk-nanotech-strategy-unavailable-due-to-technical-difficulties/#comments Thu, 18 Mar 2010 11:45:23 +0000 Andrew Maynard http://2020science.org/?p=2959

It seems the UK government Department for Business, Innovation and Skills is having a “leaves on the track” moment this morning (a scathing cultural reference, for those of you Brits too young to remember!).  The newly-minted UK nanotechnology strategy – launched today – is unavailable… because of technical difficulties it seems.

Seems to me that if the country wants to lead the world in advanced technologies, it needs to come up to speed with existing technologies first!

I had intended reviewing the strategy today on 2020 Science.  Looks like this will have to wait.  Fortunately a friend of a friend managed to pass on a copy from the bowels of BIS, so I should be able to write about it sooner rather than later.

In the meantime, if you want to try your hand at getting a copy of the new and improved strategy, the link is http://interactive.bis.gov.uk/nano/

Good luck!

Update 3/18/10, 8:55 AM – Frank Swain has kindly uploaded a copy of the UK Nanotechnologies Strategy here [PDF, 2.4 MB]

Update 3/18/10, 9:05 AM – Looks like the BIS website is now up and running again.  Review coming later today…

Update 3/18/10 2:20 PM – review of strategy now posted here.

Cancer treatment has been a poster-child for nanotechnology for almost as long as I’ve been involved with the field.  As far back as in 1999, a brochure on nanotechnology published by the US government described future “synthetic anti-body-like nanoscale drugs or devices that might seek out and destroy malignant cells wherever they might be in the body.”  Over the intervening decade, nanotechnology has become a cornerstone of the National Cancer Institute’s fight against cancer, and has featured prominently in the US government’s support for nanotechnology research and development.  And for good reason – nanotechnology holds the promise of treatments that can diagnose cancer earlier in the disease’s development than ever before; treat tumors using lower concentrations of chemotherapy agents, and target malignant cells while leaving healthy cells untouched.  Like many of my colleagues, I have used emerging nanotechnology-based cancer treatments as a compelling example of what is possible when we gain mastery over materials at the scale of the atoms and molecules they are made of.

So I was somewhat surprised to see the eminent chemist and nano-scientist George Whitesides questioning how much progress we’ve made in developing nanotechnology-based cancer treatments, in an article published in the Columbia Chronicle.

According to the article,

George Whitesides, professor of chemistry and chemical biology at Harvard University, said that while the technology sounds impressive, he thinks the focus should be on using nanoparticles in imaging and diagnosing, not treatment.

The problem lies in being able to deliver the treatment to the right cells, and Whitesides said this has proven difficult. “Cancer cells are abnormal cells, but they’re still us,” he said.

Whitesides went on to comment that

“It’s easy to say that one is going to have a particle that’s going to recognize the tumor once it gets there and will do something that triggers the death of the cell, it’s just that we don’t know how to do either one of these parts”

This got me thinking – because George is a smart guy and well worth paying attention to – have we somehow got so caught up in the possibilities of nanotechnology in treating cancer, that we have lost sight of the realities?

To get a better sense of where we are on nanotech-enabled approaches to treating cancer, I asked a handful of experts working in the field the following question: “What are some of the more significant science challenges researchers face in developing nanotechnology-based cancer treatments?” The responses were cautious, and clearly cognizant of the hurdles to taking scientific and technological breakthroughs out of the lab and into the market.  Yet despite this, there was an over-riding sense of optimism running through them.

Steve Rosen, Director of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University commented:

“I feel nanotechnology has the possibility of revolutionizing both in vitro and in vivo cancer diagnostics.  Therapy always remains a greater challenge and in the short term I see nanotechnology as a vehicle to enhanced delivery. The long term prospects are substantial and limited only by the creativity of individuals involve in this area of investigation.”

This was echoed by Tyler Jacks, Director, David H. Koch Institute for Integrative Cancer Research at MIT:

“Nanotechnology holds great promise for cancer therapy, in my view. That said, there is need for more research to learn the best strategies to specifically direct the nanomaterials to cancer cells following systemic administration. This will require overcoming the body’s natural filtration systems as well as optimizing the methods for tumor-specific targeting. It may be that truly tumor-specific targeting will require combinatorial approaches.”

The difficulties of overcoming biological barriers to using nanoparticles effectively in treating cancers were expanded on by Martin Philbert, Senior Associate Dean at School of Public Health, University of Michigan:

“The body’s immune system is primed to recognize particles of the size range encompassed by most therapeutic and imaging nanotechnologies.  Since elements of the immune system are coordinated and disseminated throughout the body, a major challenge is the design and fabrication of nanotechnologies that will either avoid immune cells or use them to achieve appropriate targeting without activation or suppression of immune function.

A second major hurdle is elimination from the body.  Many of the newer nanoparticles are designed to be eliminated from the body by either being ‘small’, i.e., less than 8 nm in diameter to facilitate passage with the urine out of the kidneys, or to dissolve to a size that allows for elimination through the urinary flow.  Nevertheless, the kinetics of elimination are invariably altered by the ability of the reticuloendothelial portion of the immune system to take up these materials and sequester them in lymphatic organs or interstitial spaces for longer periods than anticipated.”

Yet despite thee challenges, progress is clearly being made.  Piotr Grodzinsky, Director, Nanotechnology Cancer Programs at the National Cancer Institute noted that

“Nanotechnologies for medical applications have been maturing. Several therapeutic formulations entered clinical trials and are expected to have an impact on how cancer treatment is done in the future. Similarly, multiplex diagnostic platforms with high sensitivity and specificity are proving themselves in testing of clinical specimens and will contribute to early disease detection.”

Scott McNeil, Director of the Nanotechnology Characterization Laboratory cautioned that

“Developers of nanotech-based therapeutics face preclinical challenges that may be more involved than development of small molecule drugs…”

but went on to add

“…the payoffs are now being demonstrated in clinical trials by several companies. We are observing a consistent trend towards decreased toxicity for nanodrugs compared to their small molecule counterparts.”

And in responding specifically to Whitesides’ comments, Jim Baker, Director of the Michigan Nanotechnology Institute for Medicine and the Biological Sciences, observed that

“[George Whitesides] is correct that this is a very complex problem, with cancer as a variation of self being a central issue.  In addition, the concept of some in the material science community that nanoscale materials would be inherently better ignores potential problems related to biocompatibility and the necessity of this material to function in a wet environment.  Additionally, the concept of a “nanomachine” is fundamentally flawed because having mechanical devices of this size violates the laws of physics.  What is moving forward are bio-inspired materials that will provide incremental improvements in drug delivery and imaging that could not be accomplished with traditional materials.  Each one will be unique, however, and require its own evaluation for efficacy and toxicity, just like any other drug.  This provides a difficult hurdle, given the costs and clinical evaluations that are involved.”

Reading through these comments, I get the sense that we’re only beginning to scratch the surface of what working at the nanoscale can do for cancer treatment.  Certainly there are hurdles to be overcome – some of them significant.  And it’s important to remember that the road between lab-based discoveries and real-world treatments is a long and arduous one – even the most promising therapies can take years or even decades to get to the point where they are widely available.  Yet it’s hard to avoid being caught up in the enthusiasm of scientists working on nanotechnology-enabled cancer treatments, or not to  be inspired by what might be achieved through engineering increasingly sophisticated therapeutics at the nanoscale.

That said, expectations on how nanotechnology will impact cancer treatment clearly need to be tempered.  In this respect, I thought that the comments from Jennifer West, the Isabel C. Cameron Professor of Bioengineering at Rice University, were particularly well-grounded:

“Nanotechnology isn’t a magic solution to cancer, but provides additional tools in the arsenal, some with new and unique properties.  As with any cancer therapy, the key issue is to get the therapeutic agent to tumor sites and metastases at high concentrations, then destroy cancerous cells while minimizing damage to normal cells.”

Nanotechnology is clearly not a panacea.  It provides exciting new opportunities for treating cancer.  But its use also faces many scientific, economic and regulatory hurdles.  Yet the idea of crafting more effective cancer treatments by engineering matter at the nanoscale remains a compelling one – if only we can work out how to translate the idea into practical solutions.

As one of my sources – who preferred not to be named – commented:

“I don’t think that the field needs a reality check but rather ways to move more of the discoveries and developments into humans”

]]> http://2020science.org/2010/03/02/nanotechnology-and-cancer-treatment-do-we-need-a-reality-check/feed/ 16 http://2020science.org/2010/02/18/us-government-kicks-nanotechnology-safety-research-up-a-gear/ http://2020science.org/2010/02/18/us-government-kicks-nanotechnology-safety-research-up-a-gear/#comments Thu, 18 Feb 2010 14:04:44 +0000 Andrew Maynard http://2020science.org/?p=2912

It looks like the US is heading for some serious action on addressing the safe development and use of nanotechnology-enabled materials, products and processes in 2011.  Reading through the just-released National Nanotechnology Initiative’s (NNI) Supplement to the President’s 2011 budget [PDF, 1.2 MB], there are some noteworthy inclusions:

• The US Food and Drug Administration (FDA) is requesting $15 million in 2011 to address nanotechnology environment, safety and health issues.  This is the first time that the agency has been listed in the NNI budget supplement as requesting nanotechnology-specific funding.  Previously hobbled in its approach to supporting the responsible development of nanotechnology because of a lack of funding, this should go a long way to help the agency get on top of critical oversight-related questions.  The requested funds will support laboratory and product testing capacity, scientific staff development and training, and collaborative and interdisciplinary research to address product characterization and safety.
• The US Consumer Products Safety Commission (CPSC) also joins the FDA in being part of the NNI budget cross-cut for the first time since the NNI was formed.  For 2011, the CPSC is requesting a much-needed $2.2 million to allow it to participate with other agencies in researching safety aspects of nanomaterials use in consumer products.  Planned work includes developing protocols to assess the potential release of airborne nanoparticles from various consumer products and to determine their contributions to human exposure; determining whether nanomaterials can be used for performance improvement in sports safety equipment such as helmets and kneepads without creating other health hazards; and expanding consumer product testing using scientifically credible protocols to evaluate the exposure potential from nanosilver in consumer products, with special emphasis on exposures to young children.
• The National Institute for Occupational Safety and Health (NIOSH) is requesting $16.5 million for nanotechnology safety research in 2011; over 5 times more than the agency’s 2006 nanotech budget, and $7 million above the estimated 2010 budget.  NIOSH has been leading the charge on developing safe workplace practices for handling engineered nanomaterials in recent years – and all on a shoestring budget.  This significant increase in funding should help the agency address critical research needs it been struggling to cover adequately, including much needed work on exposure measurement and characterization.
• The National Institute for Standards and Technology (NIST) budget for nanotechnology safety research is set to double, going from an estimated $3.6 million in 2010 to a requested $7.3 million in 2011.  The agency will target its nanotechnology safety program to measuring the dynamic physico-chemical and toxicological properties of key nanomaterials and the release of these nanomaterials during manufacturing processes and from products throughout full product life cycles.

When requests from other agencies are included, the 2011 budget request for targeted nanotechnology safety research across the federal government for 2011 comes to $116.9 million – three times the amount invested in 2006.

This is an extremely welcome move, and demonstrates that the US government is committed to investing in research that will underpin the development of responsible nanotechnology.

Back in 2006, I estimated that the US government needed to invest at least $106 million per year in research addressing short term nanotechnology safety issues.  More recently in 2008, I set out funding options for addressing critical nanotechnology safety needs – arguing that between $20 million and $100 million per year should be invested over and above existing funding at the time (around $60 million per year).  While I can’t take credit for the apparent convergence between recommendations and budget requests here, it is gratifying to see agency-wide investment come closer to what has been suggested is needed in order to make headway in underpinning responsible nanotechnology.

Interestingly, budget requests for five key agencies align reasonably closely with those 2008 recommendations.

EPA, NIH (specifically, the National Institute for Environmental Health Sciences) and NIOSH requests are not too far from what I estimated as a compromise research investment option that lay somewhere between the minimum and the ideal.  What is particularly encouraging though is the requests for NIST and FDA, which far exceed these estimated budgets.

Of course, these requests only tell half the story.  The other half concerns how the funds are spent, and whether they will enable significant progress to be made towards developing responsible uses of nanotechnology.  In the past, the NNI has been criticized for not having a robust nanotechnology safety research strategy and for being weak on supporting targeted safety research within mission-driven agencies.  While the jury is still out on the strategy, there is no doubt that the 2011 marks a significant shift towards supporting safety research within mission-driven agencies.  In 2006, 21% of the nanotechnology environment, safety and health federal research budget was associated with EPA, NIOSH and NIST. for instance  In 2011, that figure is projected to rise to 37%.

We’re not out of the woods yet on ensuring we have the information needed to develop and use new nanotechnology-based materials and products safely.  But it looks like the US is making progress.  And that’s good news for anyone hoping to see the emergence of strong nanotechnology-based solutions to a whole host of challenges.

Well I guess I set myself up good and proper – I should have realized that in asking people for their questions on nanotechnology safety last week, they would actually want answers!

Having failed miserably to compile a catalog of websites that provide clear and concise answers to the questions asked in last week’s blog (I gave up after the 6th question),  the least I can do is provide some my own answers.  So here they are…

This being a blog and it only being an hour ’till lunchtime,  the answers are rather brief and off the cuff.  Hopefully they are of more use than not.  But if something doesn’t seem right, please check it out – and let me know.

Before I begin though, I must thank the brave souls who did attempt to provide links to answers in the previous blog – thank you!

The Questions, and some Answers:

1.  What sort of nano budget does FDA have?

If you look at the National Nanotechnology Initiative budget – a compilation of US federal agency investment in nanotechnology – FDA does not have a specific nano budget.  That said, the agency does have a number of people working on regulatory issues associated with nanotechnology in general, and engineered nanomaterials specifically.  FDA also supports the National Toxicology Program in the US, which is investigating the toxicity of a number of engineered nanomaterials, and has its own labs at the National Center for Toxicology Research, which are involved in nanomaterial toxicity studies.  So while it is tough to get a handle on the agency’s nano budget, this doesn’t mean they are not working in the area.

2. With something like nanosilver, is it possible to design out the hazard while keeping the “benefits”?

This is a tough one.  It would be nice to be able to do this, and there may be some possibilities here.  The main way silver kills microbes is to release silver ions, which are toxic to many microbes.  Silver nanoparticles are useful in that they release ions (effectively they dissolve) faster than the same quantity of larger particles, and they can be added to a wide range of products.  There is also some evidence that the nanoparticles themselves might be harmful to microbes.  The big problem here is that you have to have the ions to be effective – and if you are releasing the silver ions into the environment, they could do more than just kill the microbes you want them to.  But if there was a way to limit the rate of release and ensure only the microbes you want to get rid of come into contact with the silver ions, it might be possible to reduce possible risks while increasing benefits.  Some of the smarter uses of silver as an antimicrobial seem to be taking this approach.  The thing we really don’t want to do here is release silver nanoparticles into the environment without much thought, where they will continue to release ions and potentially cause damage.

3. What are some of the most interesting nanoparticles found in nature (not manufactured in the lab)?

I guess it depends what is meant by “interesting.”  Certainly, nanoparticles are a fact of life, and were long before humans were around.  Anything that burns and many things that get very hot release nanoparticles – think fires and volcanoes.  Liquid sprays that contain small amounts of dissolved substances can also produce nanoparticles as they evaporate – sea spray for instance is a great source of nanoparticles.  And then you have reactions between different chemicals in the atmosphere that produce nanoparticles.  Photochemical smog is a great example of man-made atmospheric “nanoparticle factories.”  But nature was there before us – terpenes released by trees can form nanoparticles in the atmosphere (the blue haze associated with the Blue Ridge Mountains is a result of naturally occurring nanoparticles).  These are all certainly interesting nanoparticles.  But they usually differ from engineered nanoparticles in that they are usually complex mixtures of nanoparticles and other stuff.

4. When will we know if it’s safe enough? I understand toxicity eg nanotubes. Do we think we can mitigate? What is safe enough?

I’m afraid that “safe enough” is a question that only policy makers, citizens and others can answer.  Science can provide information on how safe – or how risky – something is.  But then it’s up to others to work out when this is okay, and when it is not.  When it comes to nanotechnology, the first step is dividing nanotech into specific materials and products, as each will present different safety questions – including how safe is safe enough.  For example, safe enough for a cancer treatment will be very different from safe enough for a baseball bat.  We then need to work on where the plausible risks are – the materials and products that are more likely to present safety issues that we are not set up to handle well.  Then, we can start to work out where the knowledge gaps are, and how to fill them.  Governments and industry around the world are a good way along this path, although there is a long way to go still before some products of nanotechnology can be deemed “safe enough.”  For instance, we still don’t have a good handle on how to use carbon nanotubes safely, or what the safety issues around developing nanoscale food ingredients are.  On the other hand, there are nanotech-related products that, on the current balance of evidence, appear to be reasonably safe – I would consider sunscreens using well-engineered nanoparticles of titanium dioxide and zinc oxide in this category.  The bottom line though is that we still need to work on defining what is safe enough, and identifying new safety issues that emerge as nanotechnology progresses.

5. Given the nano-size of the particles, are there any effective respirator filters to guard against inhalation?

Yes.  There are some unanswered questions here, but in general, respirator filters are better at capturing nanometer-sized particles from the air than larger particles.  It sounds counter-intuitive, but the secret lies in Brownian motion.  Smaller particles are batted around more than larger particles by air molecules, and as a result are more likely to collide with and stick to the filter fibers or membrane.

6. What do you feel the repercussions are for extended life through utilization of nanotechnology?

Interesting question.  I think there are profound implications associated with the possibility of extending life – especially extending the span of productive/high quality life.  And nanotechnology is one of a suite of technologies that could lead to significant extensions to lifespan. Yet I’m not sure that nanotechnology per se raises questions as much as the implications of extending life – no matter what the technology used.  In thinking about the “repercussions” (I prefer “implications”) of extending life more generally, a lot has been written on this.  The possible implications are both fascinating and challenging – ranging from the possibility of severe planetary over-population, to extreme (and divisive) divides between those with and without access to life-extension technologies, to the possibility of greater environmental and social awareness as people become more aware that they have to live with the consequences of their actions.

7. How are safety tests carried out in nano tech?

There are suites of toxicity tests that are used to determine the hazard associated with chemicals.  Which ones are used depend on the regulations governing the material and how it will be used.  For instance, the toxicology tests on a new drug are substantially more comprehensive than those that would be used on a new cosmetic.  Some of these use cell cultures – in vitro tests.  Some of them are able to provide an indication of hazard without cells, by probing the chemical nature of a substance.  In other cases, computer models are used to get a handle on how toxic a new substance might be.  Most toxicologists agree though that most of these tests only go so far in predicting how a new substance might harm humans, and at some point tests with animals are needed – in vivo tests.  There are moves around the world – and rightly so – to minimize animal testing, and to find alternatives where possible.  Unfortunately, when it comes to brand new materials such as some engineered nanomaterials, it is extremely hard to predict how these materials might behave in a living organism from modeling and cell cultures.  This problem is compounded by some established toxicity tests that have been devised for chemicals not working well for some nanomaterials.  So the toxicologists face a quandary – do they rely on non-animal tests that may not be adequate, and risk allow products on the market that could cause serious harm, or do they test these materials on animals, to minimize the chances of something bad happening?  It’s a tough question.  But the bottom line is that most people involved in ensuring people are not harmed by new products will use the best possible suite of tests to provide them with the best possible information on product safety.

8. Seems that (nano)tech is moving v.fast. Is there a risk that results of safety testing will be out-of-date as soon as printed? How to keep up pace?

This is a challenge for sure.  I don’t think that sound toxicity tests will be quickly out-dated.  But I do think that there is a danger of increasingly sophisticated engineered nanomaterials being produced and used before we have a good handle on how to evaluate their risks, and develop protocols for safe use.  I would argue that in order to keep pace with the technology we need to rethink how we approach safety:  We need to work out how to reduce possible risks before we have all the safety data (by reducing exposures for instance); we need to learn how to predict possible hazards, and work out how to engineer them out of products during development; and we need better ways of tracking new developments so that we can respond quickly to safety issues.  We’re making some progress here.  But we have a heck of a long way to go still.

9. Is it possible/ necessary to regulate the use of materials which don’t yet exist?

It’s tough to regulate something that doesn’t exist!  What we can and probably should do is to use regulation, and other forms of oversight, to create frameworks within which emergent risks will naturally be identified and addressed – more a set of principles than hard command and control regulation.  The trick here is not to think of regulations as a list of “do not’s”, but as sophisticated tools for reducing uncertainty and increasing safety as businesses develop new materials and products.

10. We all want safety decisions to be informed by sound science, yet decisions must be made (indeed are being made) now, in most cases with relatively little useful data. What’s the soundest way to approach such decision making?

The million dollar question, as new materials and products come along faster than the safety science can keep up!  I would argue that we always have to come back to evidence-based decision-making as the foundation of what we do here, but that we desperately need new tools for making decisions in the absence of hard data.  There are a number of approaches to this that are emerging.  Control banding for instance is an approach to reducing risks in the workplace in the absence of good exposure data, and may be extend-able to working with new nanomaterials.  Multi-Criteria Decision-Making is another approach that is being developed to make decisions where data are lacking, or where the data are complex.  Then there are a number of approaches to filling gaps in toxicity and exposure data when trying to develop safety guidelines for new materials.  So we have some tools in the toolbox here for making decisions in the absence of data.  But the reality is that, looking to the future, we are going to be increasingly faced with situations where the data are incomplete, or the evidence is complex, and we are going to have to get increasingly sophisticated with how we make decisions in these cases.

11. Are their any lessons learned (societal/ethical issues) from GM foods that could be applied to the engineering or mechanical manipulation of foods through nanotechnology?

Enough to fill a book is the answer I think.  I’ll just touch on a couple here though.  First, issues associated with nanotechnology is very different from the issues surrounding genetically modified foods, and it is dangerous to compare them too closely.  For one thing, while GM foods are reasonably well-defined, nanotechnology is an umbrella term encompassing a huge diversity of technologies.  But looking to the GM food debate (some would say debacle), two critical issues were perceived heavy-handed tactics from big industry, and a lack of transparency – it seemed that what people really didn’t like was companies making decisions on their behalf, then not telling them about it!  Looking to nanotechnology, there are a number of important lessons to be learned here about how to engage with people when developing and introducing a new technology, to ensure that it is what people want, that they understand the pros and cons, and that they have

12. What should consumers know about nano-foods that labels won’t tell them?

“Should” is a strong word.  But I do think that many people would like to know that they could find out more about how nanotechnology was being used in the foods they were eating – and I’m sure regulators would like a better handle on this as well.  In terms of information that would be useful, I think you have to look at the ingredients list – a simple “nano-inside” sticker is a non-starter as it contains no useful information, while possibly raising speculative and in many cases unsubstantiated concerns.  On that ingredients list, I think it would be useful to identify where something has been specifically engineered at the nanometer scale and added to the food to add value to the product.  This could simply be a case of adding a “n” before the ingredient – nSiO2 for instance.  But this in itself isn’t of much use to the user – without more information, they won’t be able to tell whether that “n” is a good thing, a worrisome thing, or nothing worth fretting about at all.    What I think would be far more helpful is finding a way to link from product labels to more detailed information on the web.  Imagine for instance that you could take a snapshot of the bar code on a product using your smart phone, and be taken to a database that let you know what was in the product and why.  This would be a farm more effective way of providing people who were interested with useful information on the nano in their food – if and when it gets there (and there are remarkably few food products on the streets that clearly and unambiguously contain engineered nanomaterials).  The good news is that this is a technology which is already gaining ground.

13. Nanotech pervades all sectors and there is a huge range in riskiness between the applications. How can we develop a meaningful triage system to prioritize sectors, product classes, products and materials with respect to safety?

Short answer – stop talking about nanotechnology, start talking about specific technologies and the products that use them, and make sure we ask scientifically plausible questions about potential risks, rather than being driven by speculation.  This is a huge issue – not just for nanotechnology – and more thinking is needed on how we begin to identify and address plausible safety issues, without being side tracked by questions that, while interesting, are more speculative than scientifically sound, and run the risk of distracting attention from more important issues.

14. How will we deal with imported nano products and how will we know they are nano?

With great difficulty I think.  Oversight of imported products – whether nano or not – is a major issue in today’s globalized market.  It’s a problem that has got regulators the world over worried.  Add nanotech in, and the problem becomes even greater – because now you have products with components that may lead to new safety issues, that do not have to be identified, and are not easy to detect!  I suspect though that part of the solution is to avoid getting too hung up on nanotechnology, and to start focusing on specific materials that raise new safety issues, and develop ways of detecting and overseeing the use of these materials.

15. What is the risk of NOT developing nanotech (in health care, environmental protection, economic development)?

I suspect that the answer to this question will differ wildly according to who answers it, but my opinion is that we cannot afford not to develop new technologies such as nanotech.  I would argue (and have done so on this blog) that the challenges facing humankind over the next 50 plus years cannot be solved using conventional technologies alone.  Access to nutritious food and clean water; disease treatment and prevention; clean, renewable energy – these are all challenges that we currently do not have the tools to address effectively.  Of course, nanotechnology is one of a number of emerging technologies that can help.  And any emerging technology-based solutions must be integrated with social, economic and conventional technology innovations if we are to ensure the focus remains on solving the problem rather than simply playing with the next new “technology toy.”  That said, I suspect that a failure to develop responsible and sustainable nanotechnologies will have a severe impact on people’s lives and the environment in the future.

16. What is the risk overall? Technology has not made us necessarily healthier and happier – although life expectancy has undeniable risen. Will the advances in 100 sectors be nullified by one “bad sector” (say nano use in weapons)?

I’m not sure you can talk about the overall risk of something as broad as nanotechnology.  Thinking as broadly as possible, there are risks associated with developing nanotechnology without appropriate checks and balances, just as there are risks associated with impeding its development at the expense of people who need food, water, medical treatment, energy…  But it’s far more useful to think about the pros and cons of specific applications of nanotechnology.  Of course, there is always that chance that, because we are working under this “brand” of “nanotechnology”  if something bad happens in one sector – say a new nano drug goes badly wrong – it will have a knock-on effect on other areas where nanotechnology is being used.  This is a possibility as so much has been lumped together under the banner of nanotech.  But I suspect that people are sophisticated enough not to stop using their nanotech baseball bat because the latest nano drug has problems.  Of course, this won’t stop equally sophisticated people from using nano-problems to push other agendas, if they see the opportunity.

17. We may need new bioassays. Can they be designed to simultaneously address animal welfare issues? Can they become models for use in non-nano contexts? Can there development be justified, financed and sped up on that argument?

As new toxicity testing challenges arise with some engineered nanomaterials, I see no reason why this cannot be used to stimulate further research towards minimizing the use of animals in tox testing.  In fact, I would argue that it is important that every opportunity is grasped to find more humane ways to evaluate material and product safety (this was something I highlighted as being important with my colleagues back in 2006 in a commentary in the journal Nature).  Nevertheless, I do feel it is important to ensure whatever assays are used, they lead to the use of products that will not end up inadvertently harming the user.

18. What is the difference between nanotech, biotech and synthetic biology?

Get ten experts in the same room, and they’ll give you at least twenty different answers to this one.  But here’s my take:  Biotechnology is a very broad technology that covers the use of biology in agriculture, food and medicine.  The term often refers to intentionally manipulating the genetic code of organisms – usually at a fairly crude level – to change them in ways that are perceived as being beneficial.  Nanotechnology is about engineering matter at a scale just a little larger than atoms and molecules, and taking advantage of the new and unusual properties that can result from such fine-level engineering.  Nanotechnology is often (but not exclusively) thought of as involving non-living materials.  Synthetic biology on the other hand is all about manipulating the genetic code of organisms at the nanometer scale, to either alter them in useful ways, or to create new organisms.  The truth of the matter is though that each of these terms is a clumsy shorthand for a continuum of science and technology innovation that is providing us with an increasingly sophisticated level of control over matter at the finest level – whether that be in living systems, dead systems, or combinations of the two.

19. Is there sufficient attention to the “soft science” of safety research? Governance, ethics, public relations, process research, organizational research, etc?

I would certainly argue that more need to be done here – much more.  Think about it – we live in a world where not only do we need to make decisions in the absence of information, but the very dynamics of decision-making the world-over are changing.  “Hard” science is not enough on its own to cope in this new world.  We also need to know how it fits in to a complex and shifting social, political and economic environment.  And for this, we need expertise in areas like engagement, governance, social decision-making, and a whole host of other “soft” areas.

20. The problem I have with the whole issue is that nanotech is not a “single” field, like polymers or vaccines, drugs or pesticides, say. Instead it’s a vast area of sci-tech defined rather arbitrarily by the size of the entities/particles involved. We need some way to ensure policy makers are not forced into a corner where they throw a blanket over all nanotech. How can that be achieved?

So true.  I think I touch on this a couple of times above, but somehow we need to decouple the products of nanotechnology from the brand of nanotechnology – so we can have science-informed dialogues on issues that are well-defined.  But how to do this?  We could start making sure that people have access to good information, and that they are fully engaged on the issue for a start.

21. How do we assess long term impacts in short term safety tests & decide it is safe enough?

The unfortunate truth here is that we still struggle to do this with non-nano substances, never mind the products of nanotechnology.  There are ways in which we can get a handle on what some long term impacts might be – the various assays for potential genotoxins, carcinogens etc. are helpful here for instance. But we still have a long way to go.  Maybe we should see this as an opportunity for engineered nanomaterials to stimulate some new ideas and approaches here.

22. Who is accountable if we do miss long term impacts?

Huge question.  I guess, depending on which country you are in, the lawyers would say whoever you can sue is accountable!  But beyond the possibilities of litigation, who is accountable for the impacts of decisions made – or not made – now?  Businesses developing new products are accountable to their shareholders and, perhaps surprisingly to some, their stakeholders in many cases – including customers (a number of businesses have strong value systems and codes of conduct that place stakeholders above shareholders).  This naturally leads to some degree of short to medium term accountability.  On the other hand, looking at government, it is hard to find any true accountability for the medium to long term consequences of actions – especially in an area like nanotechnology which cuts across so many departments and agencies.  Clearly, this is something that needs to be addressed.

23. What % of gov and business budget should be spent on safety?

A few years ago, a number of groups were arguing that 10% of the US nanotechnology research and development strategy should be devoted to health, safety and environmental impact-related research.  These days, I would argue that how the money is spent is at least as important as how much money is spent.  If you don’t start out with the right questions and a reasonable idea of how to get the answers, no amount of funding is going to get you to where you need to be.  That said, once you have a sound strategy, 10% of nanotech R&D is not a bad starting place.  A couple of years ago I was on a congressional testimony panel when a colleague from BASF was asked how much industry invest in ensuring the safety of a new product.  From what I remember, the answer was around 15% of the R&D budget.

24. How do we get companies to share their safety data to add to the body of evidence on safety?

Find mechanisms by which companies can share useful safety data without compromising their business, and develop trust and partnerships between businesses and other stakeholders to make data sharing easier.  This is a tough one though.  Most people in the business think it’s important and should be possible, but no-one’s come up with a viable solution yet.

25. When will 2020 Science learn to count?  (my apologies – realized after posting that I had missed four questions!)

Come off it, I’m a physicist.  Counting’s for engineers!

My apologies for the lack of links and citations here.  Time didn’t allow for more than a quick fire response – maybe this is something that needs to be added in at a later date.

Last Friday I posted 24 questions on nanotechnology safety provided by folks on Twitter and FaceBook, in a naive attempt to see if people could find matching answers on the web.  Predictably perhaps, there weren’t too many responses.  This wasn’t too surprising – I’m beginning to realize that asking for feedback on the web is about as effective as inviting complete strangers at the grocery store to come round and clean your bathroom; not that attractive a proposition.  On top of this though, the questions were tough, and web-based answers scarce.

In posting the questions, I wanted to see how easy it was to get useful information on nanotechnology safety from the web, and whether there were any resources that rose to the top of the pile as being particularly useful.  Unfortunately, I have to conclude that there are remarkably few web sites out there that clearly and directly answer the types of questions people are interested in.  It’s not only the low response rate that led me to this conclusion – I tried finding useful sites myself, and gave up after the 6th question!

It seems that, ten years after the US government launched the multi-billion dollar National Nanotechnology Initiative that put nanotechnology on the map, it’s still nearly impossible to get  straight (and fast) answers to the sorts of questions people are asking…

Of course, there are some decent resources out there if you want a general introduction to nanotechnology.  Nano & me remains one of my favorite*.  And if you are specifically interested in nanotechnology safety, there are a number of Frequently Asked Questions lists – check out the NIOSH FAQ for instance, or the SafeNano FAQ.  But there’s a curious disconnect between these lists of questions, and the ones submitted to 2020 Science.  It almost seems as if these sites are answering the questions they think people are asking, rather than the ones they are.

Whichever way you look at it, despite all the information on nanotechnology safety that you can find floating around on the web, it seems that people are still struggling to find answers to the questions that matter to them.  Rather than FAQs, they are faced with QSAs – Questions you Should Ask.

Maybe it’s time for a true nanotechnology safety FAQ (or wiki or whatever – I suspect FAQ’s are so last decade) that provides answers to the questions people are really asking, rather than the ones “experts” think they should be asking.

Wouldn’t that be a novel idea!

_______________________________

Having thrown the gauntlet down here, I feel I should do something about those 24 questions that are still hanging out there without many good answers.  So I’ll see what I can do about posting some short A’s to the Q’s from my perspective – stay tuned. [Update: link to my answers here]

*To those in the know, The US National Nanotechnology Initiative website – http://www.nano.gov – is deep well of nanotech information.  Sadly, you also need to bring along a long rope, flashlight and other spelunking gear to get anything useful out of it.  The good news is that a major update is planned for the website – maybe the new and improved nano.gov will even have some real Q&A for real people – you never know!

]]> http://2020science.org/2010/02/12/nanotechnology-safety-weve-got-the-answers-now-what-was-the-question/feed/ 1 http://2020science.org/2010/02/05/twenty-nanotechnology-safety-questions-in-search-of-answers/ http://2020science.org/2010/02/05/twenty-nanotechnology-safety-questions-in-search-of-answers/#comments Fri, 05 Feb 2010 20:26:04 +0000 Andrew Maynard http://2020science.org/?p=2863

I should warn you in advance – this is an interactive blog – there’s something I want from you!  I have a question – where do ordinary people go to get information on nanotechnology safety?

Feeling a little lazy I thought I would get you – the loyal 2020 Science readership – to help me out here.  Below are twenty questions on nanotechnology safety provided by folks on Twitter and FaceBook (okay so I’m using the term “normal people” in its widest sense).  What I would like is for readers to let me know which websites they feel best answer the questions.  This is how it’s going to work:

1. Pick a question – any question -  from the list below.
2. Do some Googling (you can use another search engine if you fancy).
3. Find a website that provides a decent answer (in your opinion) to the selected question.
4. Post the question number, the link, and anything else you would like to say, in the comments area of this post.
5. Go back to step 1 and repeat until hungry/thirsty/bored.

I’m curious to see whether people really can get satisfactory answers to their questions.  And if they can, which web resources seem to do the best job.  If enough people participate, I’ll post the results later.

So please pitch in – it’ll be fun, honest!

Cheers,

Andrew

And before I go – a big thank you to everyone who send me a question.  Great job.

_________________________

The Questions:

1. What sort of nano budget does FDA have?
2. With something like nanosilver, is it possible to design out the hazard while keeping the “benefits”?
3. What are some of the most interesting nanoparticles found in nature (not manufactured in the lab)?
4. When will we know if it’s safe enough? I understand toxicity eg nanotubes. Do we think we can mitigate? What is safe enough?
5. Given the nano-size of the particles, are there any effective respirator filters to guard against inhalation?
6. What do you feel the repercussions are for extended life through utilization of nanotechnology?
7. How are safety tests carried out in nano tech?
8. Seems that (nano)tech is moving v.fast. Is there a risk that results of safety testing will be out-of-date as soon as printed? How to keep up pace?
9. Is it possible/ necessary to regulate the use of materials which don’t yet exist?
10. We all want safety decisions to be informed by sound science, yet decisions must be made (indeed are being made) now, in most cases with relatively little useful data. What’s the soundest way to approach such decision making?
11. Are their any lessons learned (societal/ethical issues) from GM foods that could be applied to the engineering or mechanical manipulation of foods through nanotechnology?
12. What should consumers know about nano-foods that labels won’t tell them?
13. Nanotech pervades all sectors and there is a huge range in riskiness between the applications. How can we develop a meaningful triage system to prioritize sectors, product classes, products and materials with respect to safety?
14. How will we deal with imported nano products and how will we know they are nano?
15. What is the risk of NOT developing nanotech (in health care, environmental protection, economic development)
16. What is the risk overall? Technology has not made us necessarily healthier and happier – although life expectancy has undeniable risen. Will the advances in 100 sectors be nullified by one “bad sector” (say nano use in weapons)?
17. We may need new bioassays. Can they be designed to simultaneously address animal welfare issues? Can they become models for use in non-nano contexts? Can there development be justified, financed and sped up on that argument?
18. What is the difference between nanotech, biotech and synthetic biology?
19. Is there sufficient attention to the “soft science” of safety research? Governance, ethics, public relations, process research, organizational research, etc?
20. The problem I have with the whole issue is that nanotech is not a “single” field, like polymers or vaccines, drugs or pesticides, say. Instead it’s a vast area of sci-tech defined rather arbitrarily by the size of the entities/particles involved. We need some way to ensure policy makers are not forced into a corner where they throw a blanket over all nanotech. How can that be achieved?
21. How do we assess long term impacts in short term safety tests & decide it is safe enough?
22. Who is accountable if we do miss long term impacts?
23. What % of gov and business budget should be spent on safety?
24. How do we get companies to share their safety data to add to the body of evidence on safety?
25. When will 2020 Science learn to count?  (my apologies – realized after posting that I had missed four questions!)

If you ever wanted proof that the nanotechnology research community is floundering when it comes to safe working practices, look no further than a paper just published in the journal Nature Nanotechnology.  The paper, written by researchers at the Nanoscience Institute of Aragon (NIA) in Spain, surveys nanosafety practices in labs around the world.  Sadly, the flaws in the paper make the point that more needs to be done to raise safety awareness far more eloquently than its content.

The paper “Reported nanosafety practices in research laboratories worldwide” by Balas, Arruebo and Santamaria sets out to survey safety practices used in engineered nanomaterials research.  This is a critical area – anecdotal evidence suggests that good work practices are patchy in research labs, and that dismissive attitudes to safety or lack of awareness of recommended safety measures are not uncommon.  A survey of current safety practices that replaced anecdotes with hard data would have been extremely useful in helping raise the bar here.  Unfortunately, this is not that survey.

NIA is a nanotech research lab – its expertise is in creating new stuff, rather than assessing safety.  In fact the paper’s corresponding author Jesus Santamaria is the laboratory’s Vice Director.  In other words, NIA would have been a perfect participant in a safe practices survey.  But whether they have the necessary expertise to conduct such a survey is another matter entirely.

I would love to deconstruct this paper as I did the Daily Mail nanotech story on “Grey Goo” a few weeks ago.  But due to copyright I cannot reproduce it in full here, so that’s out.  Instead, I thought it would be interesting to extract a few of the key statements and recommendations the authors make, and see how they stand up to scrutiny:

“An online survey shows that most researchers do not use suitable personal and laboratory protection equipment when handling nanomaterials that could become airborne”

This is the top-level summary of the paper.  It’s a sub-heading that wouldn’t look out of place in a Tabloid newspaper.  And its impact hinges on two words – “most” and “suitable.”  Unfortunately, neither seem justified.

The paper reports the results of survey of people selected from the authors of nanomaterial-related publications published between 2007 – 2009.  240 surveys were completed – around 10% of those solicited.  Extrapolating these data to the entirety of nanomaterials researchers with that phrase “most researchers” is a large jump.  But more significant is the term “suitable.”

Out of all those researchers surveyed who thought the materials they were using might become airborne at some stage, 21% didn’t use any form of “special protection” and 30% didn’t use respiratory protection.  Yet there is no way of telling from the survey whether “special protection” (the authors’ terminology) was needed, or indeed whether any respiratory protection was needed.  A researcher handling small amounts of fumed silica for example – used as a food additive amongst other places – might well handle it using established lab safety procedures that are entirely adequate and don’t include the use of a respirator – in this survey they would be classed in the category of “most researchers” not using “suitabe personal and laboratory protection.”

“We find that only about 10% of researchers who are working with nanomaterials reported using nano-enabled hoods, and one in four did not use any form of general laboratory protection.”

The survey question associated with this statistic was “General laboratory safety during synthesis and handling: No special protection; local extraction on lab-bench; standard fume hood; fume hood with nanosized filters (i.e. HEPA); special “nano-safe” fume hood; Other.”

The jump from “no special protection” (which I would interpret as general lab safety procedures were used) to “did not use any form of genera laboratory protection” is eye-poppingly large, to say the least.  And without information on material quantities and characteristics, who knows whether “nano-enabled” hoods were in fact needed by all of these researchers?

“Despite knowing the materials they made could become airborne, about 30% of researchers did not use any type of personal respiratory protection.”

The associated survey questions were “May the nanomaterials become airborne at any stage of the synthesis: Yes; no; I don’t know?” and “Personal protection equipment when handling nanomaterials: None; mouth mask w/o filters; respiratory mask w. standard filters; full face shield w. filter; full body protective equipment; other?”

If a material became airborne in an enclosed part of the process, but not where exposure could occur, a respondent could easily answer “yes” to the first question and “none” to the second – placing them amongst the 30% alluded to.  And yet they would not have been acting inappropriately.

Around 90% of the respondents were either not aware of or did not think there were regulations at the local or national levels for handling nanomaterials… This is not surprising because only a few regulations on nanomaterials have been enacted.

Respondents were asked questions like “Are you aware of any international legislation for handling nanomaterials?”, “Is there applicable a State/Local legislation for handling nanomaterials?” and “Is there applicable a Federal/National legislation for handling nanomaterials?” As no such “legislation” for handling nanomaterials safely in laboratories exist, it’s not surprising that most respondents weren’t aware of them, or didn’t think they had been written.  I’m not sure what useful information was expected out of this question.  But it does worry me that the responses are presented to suggest a lack of awareness amongst researchers, rather than a lack of regulations.

“…nearly three quarters of respondents reported not having internal rules to follow regarding the handling of nanomaterials; approximately half did not have rules and 27.1% were not aware of any internal regulations.”

Despite the potentially confusing use of “rules” and “regulations” this is actually a useful piece of information.  The question was “Does your organization have an internal set of rules or handling nanomaterials: Yes; no; I don’t know?” One would hope that the answer was yes in most cases – clearly this is an area where more effort is needed.

“Regarding general laboratory protection measures, 24% of respondents did not use any type of protection, and 15.2% reported only using local extraction on the lab bench… Taken together this means that nearly 40% of researchers working with nanomaterials reported using none or only weak means of general laboratory protection.”

To recap, the question here was “General laboratory safety during synthesis and handling: No special protection; local extraction on lab-bench; standard fume hood; fume hood with nanosized filters (i.e. HEPA); special “nano-safe” fume hood; Other.” Looking at this, the statement made is patently wrong. “No special protection” is not the same as “did not use any type of protection.”  And local extraction on the lab-bench is not necessarily a “weak means” of control.  As a consequence, this statement is misleading at best.

“When it comes to the use of PPE [Personal Protective Equipment], about 48.8% of researchers reported not using any type of respiratory protection and 24.4% used a mouth mask without filters, which is clearly an ineffective form of protection.”

That 48.8% of researchers not using PPE includes researchers using materials unlikely to become airborne (according to the survey) – so it’s perhaps not surprising the figure is so high.  I’m still trying to work out what a “mouth mask without filters” is – not something I have ever come across.  If, as I suspect, the authors were envisaging a N95 respirator, authoritative organizations like NIOSH do not class this as “an ineffective form of protection.”

About 85% of researchers declared disposing of nanomaterials either without a special procedure (24.3%) or with the same procedure as for other chemicals (61.0%).  This seems at odds with the fact that 81% of researchers stated that nanomaterials should be treated as hazardous waste unless they are known to be non-hazardous.”

There is considerable confusion here, and it stems from an assumption that nanomaterials need to be disposed of in some unique way.  The associated question on the survey was “Do you follow a special procedure for disposing of nanomaterials?  No special procedure; the same as for other chemicals; yes, a special procedure designed for disposing nanomaterials; others?” In answering this, anyone who routinely treated nanomaterials as a hazardous material would answer “no special procedure” or “the same as for other chemicals” – which makes perfect sense.  The interpretation of the survey returns as indicating poor practices here does not hold up well to scrutiny.

51.7% of the researchers reported using the same Materials Safety Data Sheet irrespective of whether they were handling bulk or nanosized material”

The trouble is, 60% percent of researchers were synthesizing their own material, and so wouldn’t have associated Materials Safety Data Sheets – unless they wrote their own.

“Until widely accepted exposure levels and monitoring procedures become available, the general guidelines provided by reliable organizations should be immediately implemented.”

This makes sense – although some help on what defines a “reliable” organization would be useful.

“Finally, scientists should self-regulate, because they are the ones who decide how nanomaterials are handled in the laboratory and are ultimately responsible for implementing nanosafety practices.  One effective way to speed-up the adoption of safety precautions would be for journals to require a specific description of nanosafety measures within the methods or experimental section of all papers dealing with nanomaterials”

So, a survey that appears to suggest that scientists are doing a lousy job of working safely with nanomaterials in the lab suggests that self-regulation is the way to go. And to “enforce” this self-regulation, journals should impose a burden on authors that is not necessary when publishing work on a thousand and one other extremely noxious materials.  I’m still trying to get my head round this one!.

I really don’t want to slam this paper – safe lab practices for working with engineered nanomaterials are critical, and greater efforts are urgently needed.  At the same time though, it’s hard to see how questionable research like this will support progress. The trouble is, this survey seems to have been conducted by team who understand little about crafting effective questionnaires, and who have a poor grasp of what is relevant and what is not when it comes to working safely with engineered nanomaterials.

But here’s the irony – the inadequacies of the paper illuminates more eloquently perhaps than the survey itself that researchers in nanotech laboratories are out at sea when it comes to understanding safety issues: This particular group of asked the wrong questions, didn’t ask the right ones, and interpreted what they got back within a questionable framework.

Clearly, they need help.

And this is perhaps the strongest message to come out of the paper, inadvertent as it is – that more is needed and faster from “reliable organizations” on working safely with engineered nanomaterials in the lab – before someone does themselves an injury.

___________________________

I didn’t want to make a big deal of it above, but I found it worrying that on two of the questions in the supplementary information, the questions and answers are transposed.  What you have in is:

“If dry synthesis, please specify method: Co-precipitation; thermal decomposition; sono-chemistry; polymerization; reverse micelles; other”

“If wet synthesis, please specify method: Laser pyrolysis; CVD/PECVD’ mechanical attrition; electrical discharge; laser ablation; other”

Anyone involved in nanomaterial synthesis will spot that the wrong answers have been mateched with the wrong questions.  Hopefully this was just an error in the supplementary information, and the original survey was correct.  But I guess someone should check…

To accompany the review just posted of Felice Frankel and George Whitesides’ book “No Small Matter: Science on the Nanoscale” the authors kindly allowed me to post this series of excerpts.  What I wanted to capture here was the synergy between the images and the prose – and how together they pull the reader in.

This is just a small taste (bad pun – sorry) of what the book offers.  If you enjoyed it and want to see more – I’m sure you know your way to a good bookstore by now.

As people seem to expect this these days, I should be clear that this is an independent review, using a copy of No Small Matter purchased from my own hard earned cash!

How do you write a book about something few people have heard off, and less seem interested in?  The answer, it seems, is to write about something else.

Felice Frankel and George Whitesides have clearly taken this lesson to heart. Judged by the cover alone, their new book “No Small Matter:  Science at the Nanoscale” is all about science in the Twilight zone of the nanoscale – where stuff doesn’t behave in the way intuition says it should.  Open the cover, and you are drawn into a seductive world of stunning images and poetic prose, that reveal as much about the authors’ passions and delights as the science that drives them. Finish the book, and you will have a far more sophisticated grasp of nanotechnology than most of your friends and, dare I say it, many of the people currently working in the field.  Because this is the sleight of hand that Frankel and Whitesides pull – by not writing about nanotechnology, they have published what is perhaps the best book on the subject to date!

But all this is besides the point.  Because more than anything, No Small Matter is about the delight of understanding and appreciating better the world in which we find ourselves.  This is a book that is simple enough for a child to appreciate, and subtle enough to keep the most cynical intellectual engaged.  It’s the sort of book I would strongly recommend you read (and read again) – not because I think you should, but because I think you’ll enjoy it.

The key to this remarkable book – and I choose my words carefully here – is the synergy between Frankel’s images and Whitesides prose (see these excerpts for an example).  Whitesides’ writing is poetic, engaging – it draws you in.  Even re-reading the book for this review, I find myself savoring the lines.  It’s not that Whitesides avoids long words and complex ideas – try this one for size for instance: “Anthropomorphizing capillarity into affection or avarice is misleading but unavoidably appealing.”  But he writes with an openness, enthusiasm and deceptive simplicity that pulls the reader in – you can almost see the glint in his eye as you read.  Take this passage for example from the book’s introduction:

“This book is about small things.  They’re different – sometimes really, and enthrallingly, different.  We humans have always been fascinated by “small”: the gears and springs of a fine watch, embroidery, a jumping spider – each is a distinct kind of marvel.  We think of ourselves as master artisans, and we have a connoisseur’s appreciation of delicate work.”

Rather than lecturing, Whitesides seeks to help you see the world through his eyes.

But the prose – beautiful as they are – are only part of the equation here.  The real genius of the book is the merging of Whitesides’ writing with Frankel’s images.  On their own, many of the images appear mundane (although the skill behind them is far from trivial).  Placed alongside Whitesides’ writing, something special happens.  The images draw out the full flavor of the prose, seasoning them to perfection.  Take this description of combustion:

“The smallest flames share features in common with the largest: a burning candle tells the story as well as a coal-fired electrical power plant; only details are different in a coal fire and a diesel engine.  Here, the heat from the flame melts the hydrocarbon candle wax; the liquid wax climbs up the wick; heat radiated from the flame vaporizes the wax; the vapor mixes with air; a complex series of chemical reactions in the hot region – the flame – convert wax and oxygen to carbon dioxide and water.  At an intermediate point in the flame zone, small particles of unburned carbon – at a temperature of approximately 1000 C – glow yellow.  When combustion is incomplete, unburned carbon particles cool to smoke or soot.”

The story is elegantly told.  But it is Frankel’s exquisite photograph of a candle flame beside it that connects the description to reality, and helps you appreciate the intricate science involved in an apparently simple process.

Another wonderful example comes in Whitesides’ discussion of wave-particle duality, which is dominated by his thoughts on math and poetry:

“We’re burdened by a curious conditioning that blinds us to one of the greatest—perhaps the greatest—of art forms. We live for poetry; we live in terror of equations.

We see a poem, and we try it on for size: we read a line or two; we roll it around in our mind; we see how it fits and tastes and sounds. We may not like it, and let it drop, but we enjoy the encounter and look forward to the next. We seen an equation, and it is as if we’d glimpsed a tarantula in the baby’s crib. We panic.

Equations are the poetry that we use to describe the behavior of electrons and atoms, just as we use poems to describe ourselves…

Poetry describes humanity with a human voice; equations describe a reality beyond the reach of words. Playing a fugue, and tasting fresh summer tomatoes, and writing poetry, and falling in love all ultimately dissolve into molecules and electrons, but we cannot yet (and perhaps, ever) trace the path from one end (from molecules) to the other (us). Not with poetry, not with equations. But each guides us part way.

Of course, not all equations are things of beauty: some are porcupines, some are plumber’s helpers, and some are tarantulas.”

And the accompanying image?  A photograph of Louis de Broglie’s wave equation – hand written.

But I don’t want to leave you with the impression that the images are merely an illumination for the text.  Some of them  capture perfectly the world of the nanoscale.  Others are cleverly crafted metaphors – a glass apple with a cubic shadow for instance; a metaphor for quantum objects that have attributes that seem irreconcilably at odds.

The heart of the book is sixty short essays, accompanied by images.  These are divided into seven sections, loosely covering “smallness;” strange behavior at the nanoscale; living things; why science at the nanoscale matters; dangers and challenges; and whether this is all the next big thing, or merely a storm in a teacup.  The essays are loosely linked, but each stands on its own.  Taken together, they seem at first to follow a random walk through Whitesides’ imagination – a comfortable mix of personal reflection and science on subjects that pique his curiosity.  But rather cleverly, they coalesce to provide a coherent sense of nanoscience.  And in doing so, provide what is perhaps the most honest and clear sense of nanotechnology that I have read.

The challenge here is that nanotechnology is not back and white – it’s not easy to say “this is nanotechnology; that is not.”  Other writers have tried to draw clear lines around the technology.  But in doing so, they have come perilously close to diminishing the wonder of seeing how the world works at the nanoscale, or the innovation that comes from using this knowledge.  Frankel and Whitesides on the other hand don’t draw boundaries – they are content with talking about stuff that is small, and different, and exciting, and awe inspiring.  They are happy working in gray areas that defy clear definition.  And they set out to enlighten, not instruct.

The result is a book that will delight anyone with an interest in the material world and an appreciation of poetic prose and eye catching images.

A series of image and text from the book can be seen here.

__________________________

As people seem to expect this these days, I should be clear that this is an independent review, using a copy of No Small Matter purchased from my own hard earned cash!

For more information on the book and the review, check out the 2020 Science Facebook page

Hype, scare mongering, obfuscation and just plain misinformation – the scientific community are reasonably clear about what they think of Tabloid science reporting much of the time.  So I wasn’t too surprised to see the headline “‘Grey goo’ food laced with nanoparticles could swamp Britain” in today’s Daily Mail, following the release of a new report on nanotechnologies and food from the UK House of Lords.  Here we go again I thought – cheap misrepresentation to pull the punters in and never mind the fallout.  But on closer reading, perhaps this piece isn’t as crass and misleading as I initially thought…

Partly as a bit of fun, I thought I would deconstruct the piece, to try and work out whether there is some sense here behind the apparent madness.  But I also have a bit of a soft spot for its author, Fiona Macrae.  Fiona was largely responsible for educating me in the ways of Tabloid reporting a few years ago.  It was the launch of the Project on Emerging Nanotechnologies Consumer Products Inventory, and I was talking with a group of reporters at the UK Science Media Center.  I remember Fiona clearly – she was smart, engaged, asked intelligent questions.  I was effusive in my answers.  And shocked when I saw her story the next day.

Rather than telling my story, she told hers.  Under the banner “‘Hidden danger’ in anti-ageing cream” she appeared to take my carefully considered words and turn them on their head.  Of course, it didn’t help that, in the course of our amiable interview, I had told her “We are using humans as guinea pigs with a lot of this.”  The lesson: she was a skilled reporter, and I was naive!

Having been on the sharp end of her pen, I was interested to read today’s story with a slightly more dispassionate eye.  Here’s what I thought, section by section:

The headline: ‘Grey goo’ food laced with nanoparticles could swamp Britain

What an emotive headline – a new danger, infiltrating our food, and threatening to overcome us!  From a purely literary perspective, the imagery is wonderful – “‘grey goo food’” brings back recollections of old-style British cuisine, while “laced” and “swamp” are loaded with menace.  But is it inaccurate?  Placing grey goo in inverted commas tells us that this is shorthand for something, and not to be taken too literally.  According to the report the piece is based on, food could hit the shelves that contains nanoparticles (and is probably already there) – “laced” is descriptive, but not inaccurate.  Saying Britain could be swamped with these foods is a bit of an exaggeration – but it is possible that in the future significant numbers of food products could use nanomaterials in some way.  So while the headline is attention-grabbing, it avoids being plain wrong.

Britain is on the brink of a massive expansion in foods containing controversial ‘grey goo’ nanoparticles, according to the former head of the Food Standards Agency.

Low-calorie chocolate and beer that doesn’t go flat could be on sale within just five years, Lord Krebs said last night.

Is Britain on the brink of a massive expansion of foods containing nanomaterials – aka “‘grey goo’ nanoparticles”?  Not unless industry and government do something to ensure the safe and successful development of the technology, according to the House of Lords report.  But the statement isn’t too far from the truth.  And the chocolate and beer examples are accurate.

However, he and other peers believe there will be no requirement for the hi-tech products to be labelled as containing nanoparticles – microscopic compounds that can worm their way into the brain, liver and kidneys with unknown consequences.

Here we see the real skill of the Tabloid writer – technically correct writing with worrying embedded subliminal messages.  Sure the Lords writing the report didn’t believe labeling is the way to go – although they did come up with another solution to ensure people had access to relevant information.  And some nanoparticles can get to the brain and kidneys, with unknown consequences.  But by saying they ‘worm their way in’ Macrae conjures up images of slimy parasites and worse – would you want anything “worming” its way into your body?

But critics said the public have the right to know what they are putting into their bodies, and point out that new legislation will mean that cosmetics that contain nanoparticles will have to be clearly labelled.

Correct.  And the full report addressed this.

Once derided by Prince Charles as ‘grey goo’, nanoparticles are tiny particles – 300 million would fit in a pinhead – with powerful properties that make them of interest to food companies.

Although they are small, they have a large surface area at which key chemical reactions can take place. This means that relatively low numbers of sugar nanoparticles can have the same effect as a large amount of normal sugar, creating tasty chocolate or cakes with a fraction of the calories.

The same principle could be applied to fat, allowing the creation of low-fat icecreams and mayonnaise that taste like the real thing.

Nanotechnology-inspired packaging promises to improve food shelf-life, and in the U.S. plastic beer bottles have been lined with ‘nanoclay’ to stop the brew from going flat.

This is all good and useful information.  Having grabbed the Tabloid reader’s attention, Macrae is now feeding them some useful information.

Lord Krebs chaired an inquiry by the House of Lords science and technology committee into the safety of nanotechnology in food, which found that although there is no evidence that the tiny particles are harmful, there are ‘large gaps’ on our knowledge.

The committee called for the Food Standards-Agency to compile a database of nanoproducts that can be accessed by the public. The FSA is not in favour of nanoparticles being declared on food labels, saying they are cluttered enough already.

This is accurate reporting – still on a roll here.

The inquiry also criticised the food industry for being unnecessarily ‘ secretive’ about the products it has in the pipeline. It said this seemed mainly to be because it was concerned about the public’s reaction.

Julian Hunt of the Food and Drink Federation said: ‘Given that nanotechnology is in its infancy in the food and drink sector, and that bringing innovations to market is a long and complex process, we are surprised that the report seems to criticize the food industry for an apparent reluctance to communicate extensively on this subject.

‘There are many questions and unknowns about the potential future uses of nanotechnologies in our sector, and there is much work still to be done by scientists, governments and regulators, as well as the food and drink industry.’

And we finish with the report’s critique of the food industry – which was the main thrust of the associated press release – and a response from an industry representative.

And at the end of the piece, I have to say that it is largely accurate and informative – emotive maybe, but not seriously misleading.  I would actually go further and say that, once the in-your-face headline and opening sentences have pulled readers in, they might actually learn something!

Of course, the fear is that readers will miss the nuances and not read past the headline and, as a result, get completely the wrong end of the stick.  I wonder how likely this is in this case though. Do people really believe in “grey goo” or is the joke on over-sensitive scientists here?

There are obviously major issues surrounding science reporting in the Tabloids, and I don’t for one minute want to give the impression that I am supporting dangerously misleading and disingenuous reporting.  But in this instance, there’s little of substance to complain about once you get beyond the occasionally jarring language.  And it might actually lead to some readers having a better grasp of what nanotech has to do with food… possibly!

Go Fiona!

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

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

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

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

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

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

Nanotechnology and Food

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

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

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

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

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

Knowledge gaps

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

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

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

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

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

Regulation

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

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

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

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

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

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

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

On labeling, the report states

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

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

Communication & Outreach

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Ten years ago at the close of the 20th century, people the world over were obsessing about the millennium bug – an unanticipated glitch arising from an earlier technology.  I wonder how clear it was then that, despite this storm in what turned out to be a rather small teacup, the following decade would see unprecedented advances in technology – the mapping of the human genome, social media, nanotechnology, space-tourism, face transplants, hybrid cars, global communications, digital storage, and more.  Looking back, it’s clear that despite a few hiccups, emerging technologies are on a roll – one that’s showing no sign of slowing down.

So what can we expect as we enter the second decade of the twenty first century?  What are the emerging technology trends that are going to be hitting the headlines over the next ten years?

Here’s my list of the top ten technologies I think are worth watching. I’m afraid that, as with all crystal ball gazing, it’s bound to be flawed. Yet as I work on the opportunities and challenges of emerging technologies, these do seem to be areas that are ripe for prime time.

Geoengineering

2009 was the year that geoengineering moved from the fringe to the mainstream.  The idea of engineering the climate on a global scale has been around for a while. But as the penny has dropped that we may be unable – or unwilling – to curb carbon dioxide emissions sufficiently to manage global warming, geoengineering has risen up the political agenda.  My guess is that the next decade will see the debate over geoengineering intensify.  Research will lead to increasingly plausible and economically feasible ways to tinker with the environment.  At the same time, political and social pressure will grow – both to put plans into action (whether multi- or unilaterally), and to limit the use of geoengineering.  The big question is whether globally-coordinated efforts to develop and use the technology in a socially and politically responsible way emerge, or whether we end up with an ugly – and potentially disastrous – free for all.

Smart grids

It may not be that apparent to the average consumer, but the way that electricity is generated, stored and transmitted is under immense strain.  As demand for electrical power grows, a radical rethink of the power grid is needed if we are to get electricity to where it is needed, when it is needed.  And the solution most likely to emerge as the way forward over the next ten years is the Smart Grid.  Smart grids connect producers of electricity to users through an interconnected “intelligent” network.  They allow centralized power stations to be augmented with – and even replaced by – distributed sources such as small-scale wind farms and domestic solar panels.  They route power from where there is excess being generated to where there is excess demand.  And they allow individuals to become providers as well as consumers – feeding power into the grid from home-installed generators, while drawing from the grid when they can’t meet their own demands.  The result is a vastly more efficient, responsive and resilient way of generating and supplying electricity.  As energy demands and limits on greenhouse gas emissions hit conventional electricity grids over the next decade, expect to see smart grids get increasing attention.

Radical materials

Good as they are, most of the materials we use these days are flawed – they don’t work as well as they could.  And usually, the fault lies in how the materials are structured at the atomic and molecular scale.  The past decade has seen some amazing advances in our ability to engineer materials with increasing precision at this scale.  The result is radical materials – materials that far outperform conventional materials in their strength, lightness, conductivity, ability to transmit heat, and a whole host of other characteristics.  Many of these are still at the research stage.  But as demands for high performance materials continue to increase everywhere from medical devices to advanced microprocessors and safe, efficient cars to space flight, radical materials will become increasingly common.  In particular, watch out for products based on carbon nanotubes.  Commercial use of this unique material has had it’s fair share of challenges over the past decade.  But I’m anticipating many of these will be overcome over the next ten years, allowing the material to achieve at least some of it’s long-anticipated promise.

Synthetic biology

Ten years ago, few people had heard of the term “synthetic biology.”  Now, scientists are able to synthesize the genome of a new organism from scratch, and are on the brink of using it to create a living bacteria.  Synthetic biology is about taking control of DNA – the genetic code of life – and engineering it, much in the same way a computer programmer engineers digital code.  It’s arisen in part as the cost of reading and synthesizing DNA sequences has plummeted.  But it is also being driven by scientists and engineers  who believe that living systems can be engineered in the same way as other systems.  In many ways, synthetic biology represents the digitization of biology.  We can now “upload” genetic sequences into a computer, where they can be manipulated like any other digital data.  But we can also “download” them back into reality when we have finished playing with them – creating new genetic code to be inserted into existing – or entirely new – organisms.  This is still expensive, and not as simple as many people would like to believe – we’re really just scratching the surface of the rules that govern how genetic code works.  But as the cost of DNA sequencing and synthesis continues to fall, expect to see the field advance in huge leaps and bounds over the next decade.  I’m not that optimistic about us cracking how the genetic code works in great detail by 2020 – the more we learn at the moment, the more we realize we don’t know.  However, I have no doubt that what we do learn will be enough to ensure synthetic biology is a hot topic over the next decade.  In particular, look out for synthesis of the first artificial organism, the development and use of “BioBricks” – the biological equivalent of electronic components – and the rise of DIY-biotechnology.

Personal genomics

Closely related to the developments underpinning synthetic biology, personal genomics relies on rapid sequencing and interpretation of an individual’s genetic sequence.  The Human Genome Project – completed in 2001 – cost taxpayers around $2.7 billion dollars, and took 13 years to complete.  In 2007, James Watson’s genome was sequenced in 2 months, at a cost of $2 million.  In 2009, Complete Genomics were sequencing personal genomes at less than $5000 a shot.  $1000 personal genomes are now on the cards for the near future – with the possibility of substantially faster/cheaper services by the end of the decade.  What exactly people are going to do with all these data is anyone’s guess at this point – especially as we still have a long way to go before we can make sense of huge sections of the human genome.  Add to this the complication of epigenetics, where external factors lead to changes in how genetic information is decoded which can pass from generation to generation, and and it’s uncertain how far personal genomics will progress over the next decade.  What aren’t in doubt though are the personal, social and economic driving forces behind generating and using this information. These are likely to underpin a growing market for personal genetic information over the next decade – and a growing number of businesses looking to capitalize on the data.

Bio-interfaces

Blurring the boundaries between individuals and machines has long held our fascination. Whether it’s building human-machine hybrids, engineering high performance body parts or interfacing directly with computers, bio-interfaces are the stuff of our wildest dreams and worst nightmares.  Fortunately, we’re still a world away from some of the more extreme imaginings of science fiction – we won’t be constructing the prototype of Star Trek Voyager’s Seven of Nine anytime soon.  But the sophistication with which we can interface with the human body is fast reaching the point where rapid developments should be anticipated.  As a hint of things to come, check out the Luke Arm from Deka (founded by Dean Kamen).  Or Honda’s work on Brain Machine Interfaces.  Over the next decade, the convergence of technologies like Information Technology, nanoscale engineering, biotechnology and neurotechnology are likely to lead to highly sophisticated bio-interfaces.  Expect to see advances in sensors that plug into the brain, prosthetic limbs that are controlled from the brain, and even implants that directly interface with the brain.  My guess is that some of the more radical developments in bio-interfaces will probably occur after 2020.  But a lot of the groundwork will be laid over the next ten years.

Data interfaces