Cross-posted from the Risk Science Blog

The World Economic Forum Global Risks Report is one of the most authoritative annual assessments of emerging issues surrounding risk currently produced. Now in its seventh edition, the 2012 report launched today draws on over 460 experts* from industry, government, academia and civil society to provide insight into 50 global risks across five categories, within a ten-year forward looking window.

As you would expect from such a major undertaking, the report has its limitations. There are some risk trends that maybe aren’t captured as well as they could be – chronic disease and pandemics are further down the list this year than I would have expected. And there are others that capture the headlining concerns of the moment – severe income disparity is the top-listed global risk in terms of likelihood. But taken as a whole, the trends highlighted capture key concerns and the analysis provides timely and relevant insight.

Risks are addressed in five broad categories, covering economic, environmental, geopolitical, societal and technological risks. And cutting across these, the report considers three top-level issues under the headings Seeds of Dystopia (action or inaction that leads to fragility in states); How Safe are our Safeguards? (unintended consequences of over, under and unresponsive regulation); and The Dark Side of Connectivity (connectivity-induced vulnerability). These provide a strong framework for approaching the identified risks systemically, and teasing apart complex interactions that could lead to adverse consequences.

But how does the report relate to public health more specifically?

The short answer is that many of the issues raised have a direct or indirect impact on public health nationally and globally. Many of the issues are complex and intertwined, and are deserving of much more attention than I’ve been able to give the report so far. I did however want to pull out some of the points that struck me on a first read-through:

Unintended consequences of nanotechnology. Following a trend seen in previous Global Risks reports, the unintended consequences of nanotechnology – while still flagged up – are toward the bottom of the risk spectrum. The potential toxicity of engineered nanomaterials is still mentioned as a concern. But most of the 50 risks addressed are rated as having a higher likelihood and/or impact.

Unintended consequences of new life science technologies. These are also relatively low on the list, but higher up the scale of concern that nanotechnologies. Specifically called out are the possibilities of genetic manipulation through synthetic biology leading to unintended consequences or biological weapons.

Unforeseen consequences of regulation. These are ranked relatively low in terms of likelihood and impact. But the broad significance of unintended consequences is highlighted in the report. These are also linked in with the potential impact and likelihood of global governance failure. Specifically, the report calls for

“A shift in mentality … so that policies, regulations or institutions can offer vital protection in a more agile and cohesive way.”

The report’s authors also ask how leaders can develop anticipatory and holistic approaches to system safeguards; how businesses and governments can prevent a breakdown of trust following the emergence of new risks; and how governments, business and civil society can work together to improve resilience against unforeseen risks.

Vulnerability to pandemics. Pandemic-associated risks are in the middle of the pack when it comes to potential impact, but not as high as might be expected on the likelihood scale. In 2007 and 2008 pandemics were listed in the top five global risks in terms of impact in the Global Risks Report, but have not appeared this high since 2009. With increasing talk about flu strains like H5N1, I wonder whether the relegation of pandemics from the top-tier risks is an oversight.

Antibiotic-resistant bacteria. These are flagged up right in the middle of the risk-pack as an emerging risk, and are one of the highest-ranked risks directly related to public health. The report provides little additional information beyond this though.

Food and water shortage crises. Thee are the highest-ranked risks in terms of impact below major systemic financial failure. And while they are both addressed as systemic risks, failure in each area has clear public health implications.

Rising rates of chronic disease. While overshadowed by higher profile risks, this remains an area of significant anticipated adverse impact and likelihood in the report.

Dystopic trends. The chapter addressing potential drivers of a dystopic future does not directly address public health issues. But trends that have an indirect impact on health thread through it. The impact of the current global financial crisis on jobs, working hours and benefits is highlighted, and it is noted that young people have been especially hard hit recently by a lack of career opportunities. The challenges of an aging population are also flagged. Both areas impact indirectly (and sometimes not so indirectly) on health and well-being. One of the questions for stakeholders posed here is “What measures should be taken today to deal with the changing socio-economic dynamics of an ageing population and a bulging young population?” One could equally well ask what measures should be taken to ensure the health of these two populations.

Regulatory risks. In the case addressing asking “How Safe are our Safeguards?” the report’s authors conclude that:

“far-reaching weaknesses in regulations [suggest] that we may be falling behind in our capacity to protect the systems that underpin growth and prosperity”

This report considers regulation extremely broadly, and spans everything from financial regulation to safety regulation. Yet it also stresses the need for integrated approaches to systemic challenges. The highlighted questions to stakeholders at the end of this section are particularly pertinent to health risk-related regulation and governance:

• How can leaders break the pattern of crisis followed by reactionary regulation and develop anticipatory and holistic approaches to system safeguards?
• How can appropriate regulations be developed so that firms will undertake effective safeguards?
• How can businesses and governments prevent a rapid breakdown of trust following the emergence of a new widespread risk?
• How can businesses, government and civil society work together to improve resilience against unforeseen risks?

Emerging technologies and emerging risks: In examining information on technologies and risks, the report concludes

“globally, the latest technologies are increasingly accessible to local industries, but indicators relating to confidence in the institutions responsible for developing safeguards, including those that manage the risks of emerging technologies, have not shown proportional increases.”

Special report on the 2011 Japan earthquake. The March 11 earthquake that hit Japan last year and the following tsunami resulted in widespread social, economic and health impacts. In a special report, the 2011 Global Risk Report takes a holistic look at factors, events and impacts. This is a case review that is well worth reading from a systemic risk perspective.

Risk centers of gravity. The report concludes with a fascinating analysis of risk “Centers of Gravity” within the five sectors it focuses on – these are described as the risks perceived to be of greatest systemic importance, or the most influential and consequential in relation to others, within each sector. The risk centers of gravity that emerged in each sector were:

• Economic: Chronic fiscal imbalances
• Environmental: Rising greenhouse gas emissions
• Geopolitical: Global governance failure
• Societal: Unsustainable population growth
• Technological: Critical systems failure

The bottom line? The report concludes that

Decision-makers need to improve understanding of incentives that will improve collaboration in response to global risks;

Trust, or lack of trust, is perceived to be a crucial factor in how risks may manifest themselves. In particular, this refers to confidence, or lack thereof, in leaders, in systems which ensure public safety and in the tools of communication that are revolutionizing how we share and digest information; and

Communication and information sharing on risks must be improved by introducing greater transparency about uncertainty and conveying it to the public in a meaningful way.

The Global Risks 2012 Seventh Edition is available at http://reports.weforum.org/global-risks-2012/

*I was marginally involved in the report as a member of the World Economic Forum Global Agenda Council on Emerging Technologies

My apologies for the rather crude title, but I couldn’t resist.  Australian science communicator Craig Cormick is speaking at a University of Michigan Risk Science Unplugged event on November 1, and when asked for a short and pithy title, this is what he suggested.  It was too controversial for the Risk Science Center website (and clientele), but I just couldn’t let it go to waste.

As it was, we went with the rather less controversial title of Risk Rage.

You can find out more about Risk Science Unplugged presents Risk Rage (aka Risk – OMG x WTF!) at the Risk Science Blog. The event is on November 1 at 2:10 PM Eastern Time, and will be live webcast.

This coming Thursday (Oct 20 2011), the US National Nanotechnology Initiative is releasing the latest version of the Initiative’s federal nanotechnology environmental, health and safety research strategy.  The strategy will be available for download from 10:00 AM Eastern time, with a webinar on the release being held between 12:00 PM – 12:45 PM Eastern (registration required).  Further details can be found here.

A draft of the research strategy was published in December 2010 for public comment – with the aim of using these comments where appropriate to strengthen the final strategy.

In anticipation of the final version coming out on Thursday, I’ve been revisiting the public comments received.  They are still accessible on the NNI Strategy Portal, although you will need to register to read them (my comments are available separately here).  I’m particularly interested in how the NNI has addressed them in the final strategy.

While going through this exercise, I thought it worth listing the key recommendations made within these public comments.  These are extracted from comments posted on the NNI Strategy Portal, and i many cases just represent the key recommendations made in the comments:

Richard Harenburg

The 2011 NNI EHS Research Strategy needs to provide more focus on building a collaborative informatics infrastructure. Improved speed in disseminating risk and safety information is particularly critical. Collaboration with foreign nanotechnology research organizations should be developed in this area. Priority should also be given to the signature nanotechnology initiatives such as third generation solar energy. Collaborative informatics infrastructure examples can come from small businesses that use agility and innovation to succeed and grow. Examples can also come from some foreign countries that have demonstrated agility, innovation and growth.

Jeffrey Ellis

The strategy I recommend is for each product containing a nanomaterial and its uses to be first screened by the manufacturers for potential safety problems once it leaves the production facility. The manufacturers thereof should as a matter of course provide such data. If use requires special safety equipment (gloves, masks, etc) such instruction must be provided with the product.

Bill Kojola

An integrated and linked research effort to assess, via epidemiological studies, the impact of exposure to engineered nanomaterials on human health and any necessary resultant risk assessment/management responses seems to be missing from the strategy.

Andrew Maynard

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

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

John DiLoreto, The Nanotechnology Coalition

A core mission of the NNI is to foster “technological advancements that benefit society” (Draft NNI 2011 Environmental, Health, and Safety Strategy, page 1). The NNI strategy provides valuable help in identifying key research areas and, in some cases, providing the necessary funding to conduct the research itself. The Coalition believes that to fulfill its mission in this regard, the NNI could and should direct its considerable influence and resources to educating regulatory and other officials in positions of influence about nanotechnology so they can better fulfill their responsibilities to protect the safety of consumers. The EHS research strategy should also examine ways that science-based safety information can be shared with regulatory officials and others in leadership positions and provide scientific resources to assist these officials in understanding what a ‘nanomaterial’ is and help create a better understanding of properties that may impact safety.

David Berube

Section 6, p. 56, line 23/25/26/30 – 23 conflates translation with risk communication (they are different). 25 “approaches” is unclear and should reference levels of acceptable caution. 26 high uncertainty may demand whole new algorithms – your assumption whether risk communication and risk management can be integrated is incorrect. 30 is a good point to discuss the conflation of translation which occurs between parties within similar ranges of understanding and public perception (NGOs) as well as perception of public perception (legislators). Each of these subset publics have different needs and interests and standardization of terminology is hardly sufficient to the task at hand.

p. 57 line 4 – see above and consider we might need to develop algorithms appropriate to different levels of certainty. The assumption the answer to uncertainty is more certainty is not necessarily valid for all publics. The simplified version in the document seems more attuned to strategic communication involving response strategies for different risks and certainty values involving variables like plausibility, phenomenon specificity, exigence, salience, etc.

p. 63 lines 34/37 34 (see above). 37 one model does not fit all. 38 link to trust is very complex and complicated by new/digital media sources as well as new credibility (social media) and reliability.

p. 58 lines 1/5/11/27 (see above) and this demands information sharing and transparency as well as answering how data is defined, who decides what is relevant data, how it is generated, how data is compiled and concatenated. how data is vetted and debunked, and how data is revised. 5 two ways is overly simplistic, try interactional. 11 this is a model issue and we do not have a model for high uncertainty. 27 assumes risk communication is a function of data, esp. scientific data and for many publics that is not true.

p. 76 – Explanation SP objective 4.2 re: needs of the stakeholders – it might be prudent to ask them what their needs are.

Samantha Dozier, PETA

A complete, step-wise method for rigorous characterization is imperative so that measurement is not questioned and studies are not repeated. A clear requirement for nanomaterial characterization will help eliminate redundancy and imprecise data-gathering and will aid in reducing animal use for the field.

For human health effects assessment, the NNI should promote the development of a tiered, weight-of-evidence approach that is based on the most relevant methods available and encourages the NNI to support the incorporation of appropriate in vitro human-relevant cell and tissue assays for all endpoints, instead of relying on inadequately modified, non-validated animal assays. This tiered approach should start with an initial characterization of the nanomaterial, followed by in vitro basal cell and portal-of-entry toxicity assessments according to human exposure potential and a full characterization of the toxicokinetic potential.

Martin Philbert

…it is imperative that the NNI focuses on developing and implementing a plan of action that supports coordinated and responsive progress towards addressing nanomaterial safety, despite mounting barriers to achieving this. Such an approach will need to focus less on the details of what research needs to be done – there is already a plethora of information available on this – and more on cross-agency mechanisms that will support relevant and timely research.

Chapter 8 of the draft strategy begins to address this need. I would strongly encourage the NEHI working group to build on this promising start, and develop a cross-agency plan of action that enables the necessary research to progress, despite political, social, institutional and other pressures that will inevitably obstruct it.

Maria Victoria Peeler

After much discussion and reviewing comments on this web site, as well as reviewing NNI’s proposals again, I believe it’s in order to point out that while the document makes it clear that the funding is comparatively large, but limited, the critical prioritization of current US needs to achieve sustainable use of nanotechnology is missing.

The listing of the proposed projects by each requestor does not answer the question as to which projects are 1) absolutilely necessary to survive, 2) of major importance for competitive purposes (list of competitive priorities should also be defined. For example, is economic viability a higher priority than population viability..of key species or top of the chain species?) and 3) of major importance to maintain stable diversity of all Earth meeds, to avoid global to regional catastrophy. Beyond that, each project ought to require documentation that ensures the end result will not be deletirious. We do not need to foul our own nest anymore than we have already.

Robert Wiacek

Responsible and cautious science-base risk analysis and risk management by the EHS community needs to be a priority in order to curtail any unsubstantiated fears of nanomaterials that might arise by the public and ultimately restrict the development of nano-based technology.

In the listing of the goals, Line 8 (Protects public health and the environment) should remain first, Line 10 (Fosters technological advancements that benefits society) should be second, and the last goal listed should be Line 9 (Employs science-based risk analysis and risk management). This would be more consistent with the overall fourfold goals of the NNI (Introduction, Page 1).

Ronald Turco

Overall, the effort is comprehensive looking at the history of the program. However, I keyed in on page 43 line 10, “Releases of engineered nanomaterials ….” as I feel the forward thinking part of the effort ignores “nanocomposites” (the word occurs one time in the document.)… I think the report needs to move forward a bit and start to think more seriously and address the real materials. Use of the term nanomaterials is too vague as it leaves it open as to what is actually being studied (pure forms or product materials). I think raw nanosilver gets a little too much attention – again in what form will it actually be entering the environment (page 54)? We need to be thinking about how the real materials are or will be transformed. The photochemistry work of Jafvert (Hou and Jafvert, 2009; Hou et al., 2010), the fungal work of Filley (Schreiner et al., 2009) and others are a great example of how readily these materials can actually be acted upon in the environment.

Karoly Meszlenyi, The Methodist Hospital Research Institute (TMHRI)

Chapter 2 Instrumentation, Metrology, and Analytical Methods
The monitoring of nano-materials in the environment is critically important for the protection of the safety of laboratory workers at all levels. Because of this, TMHRI suggests that additional research efforts be directed into and reliable methods for the rapid detection, identification and measurement of nano-materials in laboratory and other environments.

Chapter 3 – Nanomaterials and Human Health
Research should also be directed toward an evaluation of the relative toxicity of each type of nano-material, as well as the methods and/or routes by which each nano-material is most likely to be taken into the body. lt is particularly important to proceed with research into the most effective equipment and methods for protection of workers from exposure to nano-materials. This research should include proper techniques for the handling and disposal of equipment once it has been used.

Chapter 6 – Risk Management Methods
In addition to the activities we suggest with regard to the development of the proper equipment and methods for the handling of nano-materials, research should be conducted into the development of equipment and methods for the prevention of nano-materials spills, as well as the most effective equipment and methods for the safe, rapid and effective cleanup and remediation of any such incidents.

Gaythia Weis

I recommend that some input from industrial techniques for matrix management and virtual team building would be highly useful approaches to dealing with the inter-agency and multiple stakeholder issues… I think this document:
http://www.particlea…f/1743-8977-7-40.pdf is a great outline of how to establish protocols for working with new and unfamiliar materials, and implementation of the precautionary principle. I especially like the design tree flow chart and the figures. I believe that something very specific based on the style of this report should appear early on in the US National Nanotechnology Initiative Environmental, Health and Safety strategy document. I would place this directly after the material now in Chapter 8. Because if you want to convey concepts about health and safety you have to be clear about it. And this Particle Fiber and Technology document knows how to do that. I don’t think you can have a Environmental health and safety strategy unless you really get down to the nuts and bolts of health and safety.

The American Chemistry Council’s Nanotechnology Panel

The Panel supports the approach of integrating the risk assessment paradigm within product life cycle stages and the NNI’s overall adaptive management approach to EHS research. While we support the vision and mission in principle, we believe that the vision statement does not adequately acknowledge the potential of nanotechnology to enhance environmental quality. The panel also hopes that, contrary to the text box following the mission statement, the definition of “engineered nanomaterial” used in the EHS strategy would provide some degree of guidance (and consistency) to federal agencies developing their own definitions.

The Panel believes that risk communication deserves increased emphasis. We do not believe that it is sufficient to simply “integrate and standardize risk communication within the risk management framework” (p. 63). As nanotechnology EHS research increases, the question of what study results mean in terms of potential health or environmental risk must be communicated effectively. The draft frequently mentions increasing the availability of EHS information, but the public needs more than the numbers from a risk assessment to interpret studies and understand what risk management measures, if needed, are in place. We recommend that risk communication be more of a priority with a focus on addressing scientific uncertainty, public perceptions, and ELSI.

The draft strategy does not prioritize the need for consistent terminology in EHS research and practice. Standardized terminology would reduce confusion (e.g., routine use of primary particle size to describe materials composed mostly or entirely of aggregates and agglomerates). The lack of common terminology can lead to erroneous conclusions about the sources of potential EHS impacts and how to perform appropriate surveillance and exposure monitoring. As noted in the draft, lack of common terminology can also undermine risk communication.

The Panel notes that the term “comparative risk assessment” is used frequently, but it is not defined. Is it a comparison of different nanomaterial risk assessments or of how different properties influence risk assessment? The Panel requests clarity on the meaning of this term and notes that assessments that compare nano and non-nano forms of materials may be useful for assessing whether nano forms of materials possess increased risk relative to non-nano forms.

Although education is a major component of the overall NNI strategic plan, there are no linkages to education in the draft EHS strategy.

Günter Oberdörster

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.

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.

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

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.

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).

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.

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.

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.

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.

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?

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.

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.

“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.

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.

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?

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.

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….”.

Skip Rung

1. The document is not by any means a roadmap for “support(ing) responsible development of nanotechnology” (NNI goal #4), because it is almost completely focused on risk rather than on proactive activities (though these are briefly mentioned in a few places), and because there are no cost or timeline estimates for achievement of objectives that would enable such development.

2. Though the term “comparative risk” is used in places, there is almost no sense of comparison of the risks of using new nanomaterials with (a) conventional materials or (b) incumbent nanomaterials that were certified prior to recent precautionary blocking and slowdowns. This concern is somewhat personal : an ONAMI gap fund portfolio company, Dune Sciences, which has a better (performance and safety) nanosilver technology, has been severely harmed precisely because of an inability to make such beneficial tradeoffs. Unlike the world of “substances” under TSCA, at least some categories of new nanomaterials developed in the US are at this time practically blocked from commercialization here. This is causing loss of opportunity to Asia.

Two suggestions: a) Set appropriate comparative risk context in the introduction and all relevant sections. b) Fund comparative hazard/exposure/risk studies in a few key/prioritized cases

3. It is unlikely that more than a tiny fraction of the US public knows that the level of scrutiny (both because of genuine scientific interest and because of technophobic NGO influence) being applied to nanomaterials is unprecedented, and has not been applied to molecular (other than certain categories) or micron-scale materials. To cite two of many possible examples, molecular species in plastics used in many products (household items, electronics, automobiles) are known to outgas, and micron-scale particles (in the range most favored for deep lung inhalation) are emitted from paper products and office copiers.

4. It seems imperative to me, unless the NNI wants to be an enabler of even more loss of manufacturing and high-value product development activity in the US, to incorporate – or at least prominently mention in its introduction – a broader comparative sense of risks vs. benefits in the world of materials/substances, and to include/highlight more activity on proactive development of nanomaterials and nanomanufacturing processes, including not just “safe by design” efforts but also safe and low-impact fabrication and purification methods.

5. The occupational exposure research methods should use NIOSH-approved workplace and PPE protocols as the baseline, otherwise needless concern may be raised. If resources permit, comparing this baseline with less precautionary practices would provide useful sensitivity information.

6. There might be greater mention of biological assay methods that combine the best features of in vitro (e.g. small material requirement, high throughput) and in vivo (e.g. vertebrate development impact) studies. One is the use of embryonic zebrafish.

Thomas Peters

Major comments

1) I disagree with the order of priorities in the Human Exposure Assessment area. The authors seem confused among what can be done and what needs to be done. Ultimately, I think that most would agree that the number one need is to “characterize exposures among [people, although the word ‘workers’ was used in 2008]”. The new need #1 is to “understand processes and factors that determine exposures to NM”. I disagree with this reprioritization and suspects that this change reflects the desire to have something more easily tactically achieved in the number one slot. I do not agree that the old needs map to the new needs as indicated by the arrows in Figure 3-1.

I also suspect that the authors have overstated the progress that has been made as stated on page 22, line 10. We still know very little about workplace exposures and there should still be a focus in this area.”\

2) There seems to be an opportunity for more clear linkage among the different chapters. Additionally, the different chapters do not seem parallel as they are presented. Consequently, I sense that there is not an overarching vision within this document that is not explicitly stated.
I believe that this problem would not be overly difficult resolve. I suspect that the figure on the cover of the document was an attempt to provide linkage. From this figure, I see that areas of “Predictive Modeling & Informatics” and “Nanomaterial Measurement Infrastructure” form an important overarching core that is used by “Human Health”, “Human Exposure”, and “Environment”. Ultimately, all of these areas feed “Risk Assessment and Management”. This figure and discussion should be a central piece of the Introduction.

3) The Introduction needs to clearly state what the current strategy is apart from the old strategy. The introduction weaves back and forth between old and new. I am confused as a new reader of this document. The result of this confusion is that the entire strategy appears non-cohesive and weak.

4) The development of partnerships with industry and other stakeholders are absent in this document, or perhaps they are simply too deeply embedded for me to find.

Specific comments

…

3) Miscellaneous issues:

• Figure 1-3 appears on page 4 but is not referenced in the text until page 7. It is also not really discussed so it feels like an afterthought rather than a central piece of the document.

• P9, line 25. I find it strange that the words ‘new and improved’ are inherent to the definition of ‘instruments’. I suggest that they be dropped.

• P9, line 21. I find that “developed by national metrology institutes” is too exclusive for the definition of “standards” in a document of this scope.

Fred Klaessig

The issues surrounding safety and societal acceptance are broader than the specifics of any one technology, and for that reason, I am a proponent of Objective # 4 (EHS and ELSI) becoming the NNI’s Objective #1. Some separation should be encouraged so that the enthusiasm, the jargon and the promotional fervor do not cast a strong shadow over thoughtful EHS evaluations. The definition of nanomaterial in this document, the EHS Research Strategy, is more appropriate to the first three NNI objectives and less so to the fourth, and consideration should be given to using the ISO definition in its stead along with a qualifying statement.

1). When breathing, we inhale particles and not ‘nano-enabled’ products;
2). When these particles pass into our lungs, the smaller particles reach the deep alveoli based upon hydrodynamic flow and particle size, not ‘unique’ properties;
3). The particles that reach the deep long may lodge there, while the larger particles are coughed up and then go down the GI tract;
4). The body’s initial response to lodged particles is based on the innate immune system’s general reaction to any foreign body plus some immediate chemistry such as wetting, acid-base reactions, dissolution; and
5). The body’s long-term response is closely tied to persistent inflammation, while the localized chemical response is closely tied to biopersistence and particle migration.

The above points favor the ISO definition of nanomaterial with an advisory that for EHS purposes, we emphasize particulate matter. A suggestion would be for the definition on page 1:

nanomaterial: material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale

Note: For EHS purposes the primary interest is in respirable and ingestible particulates, where the information developed can be extended to larger nanomaterials.

Vincent Caprio, Nano Business Alliance (NbA)

First, NbA urges NNI to prioritize the development of consistent terminology to insure regulatory initiatives are properly focused. Standardized terminology reduces the potential for unwarranted and commercially stifling regulatory measures that have the potential to undermine the successful commercialization of nano enterprises.

Second, the Alliance urges NNI to enhance its commitment to educate the public, including legislators and regulators, about nanotechnology to foster a thorough understanding of the benefits nanotechnology offers.

David Wagger (Institute of Scrap Recycling Industries inc.)

Figure 1-4 [8/9–13] should show recycling pathways from Product End of Life to each preceding step (e.g., refurbished used electronics, reused electronics components, and shredded hard-drives) and identify potential recycling worker exposure. Also, the text regards recycling unevenly, including it in Ch. 2 and Ch. 3 [10/35–36; 15/11–13; 18/18–20; 20/19–26] but tending to omit it in Ch. 5 and Ch. 6 [43/22–23; 48/22–25; 62/18–20; 64/32–34]. Recycling should be identified where appropriate.

…

Finally, ISRI agrees that “stakeholders have an essential role to play” [80/3–4] and would be interested in participating in the Strategy’s efforts to meet NNI Strategic Plan Objectives 4.1.2, 4.2, and 4.3.2.

Paul Sarahan

With respect to Chapters 4 and 5, the report should emphasize the need for proposed research projects to focus on and be designed to reflect real-life material usage, exposure doses, and exposure pathways, so that the results can be easily translated to real world operations in a meaningful way.

Regarding Chapter 6, I would encourage a review of existing statutory and regulatory authority that could spur nano operations to perform risk assessments as a regular course of business. See, e.g., http://www.fulbright…technologySafety.pdf , http://www.fulbright…technologySafety.pdf

Michael Ellenbecker

Page Line Comment

14 30 TEM and SEM are very valuable tools for analyzing properties of ENMs. Standardized protocols for sample collection, preparation and analysis need to be funded and developed.

15 18 Standardized methods for evaluating workplace exposures to ENMs must receive a very high priority.

20 17 We believe that the international harmonization of exposure assessment methodologies is of utmost importance. We recommend that US NNI agencies work closely with colleagues in the EU and elsewhere to ensure this occurs. It is important to recognize that different exposure assessment methodologies are appropriate for different exposure scenarios, i.e., exposure methods used for epidemiology studies will require different measurement equipment and strategies than exposure methods used for comparison to permissible exposure limits.

20 30 Again, it is very important that consistent quantitative assessment methods be used in all countries, so data can be compared and correlated.

24 4 International harmonization and consistency is extremely important here, since it is likely that in the near future the only way to establish large enough cohorts of workers exposed to a particular ENM is by combining populations from different countries.

30 6 The lack of any funded health surveillance projects is of great concern. Such projects should be designed and funded with international partners.

30 10 The safe levels of exposures should consider the effects of available controls applied to such exposure when the evaluation was taken, this is usually important for workplace exposure. Thus, the information about the control strategies used and associated with the studied exposure has to be reported.

30 30-38 The assessments for populations who are exposed to consumer products containing engineered nanomaterials will require a different evaluation/assessment strategy compared to workplace exposures.

31 3 The assessment models require further evaluation to be adopted for different scenarios. This will need large funding to develop the tools and appropriate instrumentation.

31 5 Harmonization of assessment models and data collection with international partners is important for further development on health surveillance.

60 44 We strongly agree with the statement that studies on exposure control methods are lacking. Equal emphasis must be given to controlling exposures as to evaluating them; the current NNI strategy seems to favor evaluation over control, which is a mistake in our view.

70 15 We strongly believe that another key principle should be “Develop effective strategies to effectively control exposures to ENMs.”

72 43 We agree with the importance of international coordination. All ENM research should be performed with an eye towards international coordination.

Lockheed Martin

The recommendation to create an exposure registry deserves further exploration.

For example:

1. Who would establish the program to gather physician case reports and other reports of adverse events?
2. What constitutes exposure and what factors determine who is entered into the registry? Exposure needs to be categorized. For example, the type of nanomaterials used in the workplace, exposure estimates, and control measures should be documented. Otherwise, data might not be collected in a format or using a method which could be used for future studies.
3. There is no specific health impact identified, so would medical surveillance constitute a research study? Do the criteria and requirements for human subject research need to be applied?
4. What type of medical surveillance should be performed? There is a wide variety of nanomaterials, and it is not likely that one type of medical surveillance will suffice for all nanomaterials. With the exception of draft recommendations from NIOSH for carbon nanotubes/nanofibers, very little has been published on this issue. Thus, NNI should consider providing recommendations for appropriate medical surveillance.

References to the “transformation products” of nanomaterials and the potential for human exposure to these transformed materials appear in the Human Health and other sections of the NNI document. The draft creates the impression that generation of “transformation products” from nanomaterials is a foregone conclusion and that there is potential for a biological response. Although basic environmental chemistry may allow one to predict how a chemical will be transformed when released into the environment, this is not necessarily the case with nanomaterials/nanoparticles due to their unique properties. NNI should support well-designed studies regarding if/how specific nanomaterials are transformed in the environment. This would provide useful data while saving resources otherwise expended seeking biological responses to an unknown or nonexistent transformation product.

The use of toxicological data to create computational models for predicting toxicity in silico along with references to high throughput testing are mentioned in the Human Health section. These technologies hold great promise for the future. However, a substantial amount of work remains to be done in developing reliable, reproducible methods for conducting in vitro and in vivo toxicity testing. The emphasis for the near term should be placed on refining the latter methods and collecting data essential for developing and understanding the toxicity associated with different nanomaterials.

Christopher Bosso, Ronald Sandler, and Jacqueline Isaacs

Environmental Justice. The EHS strategy makes only one reference to environmental justice (p. 40), and not in its standard understanding as the disproportionate exposure of high-minority and low-income communities to environmental hazards. Nanotechnologies and nanomanufacturing processes are likely to produce both environmental benefits and burdens, so any meaningful EHS strategy must address research, planning, and policy outcomes necessary to ensure that nanotechnology reduces any unjust distribution of environmental burdens and benefits. It is crucial that any meaningful EHS strategy promote the development of nanotechnology ways that distribute the benefits justly – e.g., that remediation focus on toxins prevalent in environmental justice communities and that “environmental illnesses” on which resources are spent include those, such as asthma, that are more prevalent in environmental justice communities. Whether nanotechnologies are likely to exacerbate or alleviate environmental injustice depends on how they are implemented, disseminated, and situated (and who or what factors determine these); who controls them; what sorts of oversight and regulations pertain to them; and how effectively these are enforced. To address such components require substantial community engagement and significant policy development. The EHS strategic plan must, therefore, include a research strategy for these aspects of environmental justice.

Regulatory design. The EHS strategy makes no reference to fostering a deeper understanding of the suitability of existing regulatory structures and approaches to nanotechnology. There is real doubt about the efficacy of existing federal environmental and health statutes (e.g., TSCA, FIFRA), and the current capacity of federal regulatory agencies (e.g., EPA, FDA) to adequately address the expected deluge of nanoscale applications and products. The situation at the state level is of even greater concern since state governments are often in the front lines when addressing environmental and health concerns. The absence of a focus on the basic design or orientation of an effective 21st century regulatory regime is glaring.

Public Outreach and Education. Public outreach and education is among the core strategic goals of the NNI, yet the EHS research strategy nowhere addresses these concerns. Developing effective models and strategies for engaging the public about nanotechnology EHS concerns in general and in particular contexts (e.g. siting of a nanomanufacturing facility) should be part of any EHS research plan aimed at promoting the public good. For example, a crucial component of environmental justice – and of democracy – is the right of citizens to know about possible EHS concerns in their community. Strategies for communicating about EHS to communities that build on existing best practices need to be developed. Moreover, communities need to be engaged to determine what their EHS concerns are and what sorts of environmentally beneficial nanotechnologies would be most important for their community. A research strategy is therefore needed to develop effective methods of public engagement to teach and learn from a variety of “publics” regarding EHS concerns and goals. Such engagement is crucial to the responsible development of nanotechnology, and may also reveal research needs and goals that are not readily recognized by the EHS research community.

]]> http://2020science.org/2011/10/15/us-national-nanotechnology-initiative-to-release-latest-environmental-health-and-safety-ressearch-strategy-oct-20/feed/ 1 http://2020science.org/2011/09/24/emerging-technologies-and-sustainability-whats-risk-got-to-do-with-it/ http://2020science.org/2011/09/24/emerging-technologies-and-sustainability-whats-risk-got-to-do-with-it/#comments Sat, 24 Sep 2011 22:04:12 +0000 Andrew Maynard http://2020science.org/?p=4400

Question: What do you get if you place some of the leading thinkers and practitioners in the fields of technology innovation, risk and sustainability in the same room for two days?

Answer: one whopping headache!

Not because of the confusion and cacophony, but because of the overwhelming volume of information, ideas and insights that emerge.

To be honest, my less than coherent state at the end of this weeks symposium on Risk, Uncertainty and Sustainable Innovation wasn’t helped by moderating eight discussion panels over two days, and coordinating a handful more.  But without a doubt, this was a meeting that pushed the boundaries of how much a sane person can take in and remain sane.

The idea behind the symposium was simple: Bring a bunch of smart people with different perspectives together to explore the complex intersections between risk, sustainability and innovation, and see what happens.  In practice, we put together a format and a program that encouraged a candid exploration of realistic challenges and plausible approaches to developing sustainable applications of technology innovation, as well as using technology innovation to develop sustainable solutions to pressing problems.

The result: Two ideas-packed days of engaging, inspiring and challenging discussion on how businesses, governments and others can better ensure safe, successful and sustainable outcomes from technology innovation.

Having been in the thick of the discussions, I’m still trying to unravel and assimilate a lot of the ideas that emerged. And I missed a lot of the nuances – much of the time I was too intent on keeping the conversation going to be fully aware of its content.   Fortunately, the symposium was caught on video, and will be posted on the Risk Science Center’s Vimeo site in a week or so, so I will be able to revisit the discussions at my leisure.  But I did want to capture some of my initial impressions here.

New ideas for new audiences. Something I did want to achieve with the symposium was to expose people to ideas they may not have previously come across.  In this, the meeting was resounding success.  While some of the ideas being explored on innovation, sustainability, risk and communication may have been old hat to people that live and breathe this stuff, there were many others in the room who were hearing things for the first time that had a direct bearing on their work.

Innovation relating to communication, informatics, processes and systems is more relevant than “named” emerging technologies.  I had planned the first couple of sessions of the symposium to focus on technology innovation rather than risk, with the intention of ensuring the following discussions were grounded in plausibility rather than wild speculation.  I had expected these discussions to focus on the usual chestnuts – nanotechnology, synthetic biology, geoengineering, human enhancement etc. Instead, despite having experts in cutting edge emerging technologies on the panels, the discussion focused more on innovation in how we use knowledge and information – in areas like communication, informatics, processes and systems.  When pressed, panelists felt that the labels new areas of technology attract are less important than innovations that are allowing things to be done in new ways.

Risk and risk communication float to the top.  I was also intrigued to find that, try as I might, I could not keep risk and risk communication out of the conversation.  Even the panels looking at emerging areas of technology innovation naturally gravitated to the challenges of understanding and addressing emerging risks, as well as communicating information on risks and benefits effectively.

A clear synergy exists between risk, innovation and sustainability.  Although it was this synergy I wanted to explore through the symposium, I was surprised at how apparent it was that to many participants, successful technology innovation is critically dependent on taking an integrative approach to innovation, risk and sustainability.

There were also a number of personal highlights for me at the meeting, in addition to the discussion panels:

• John Viera – Director of Sustainability Environment and Safety Engineering at the Ford Motor Company – gave an inspiring talk on the company’s approach to sustainability.
• David Munson – the Robert J. Vlasic Dean of Engineering in the College of Engineering at the University of Michigan – beautifully articulated the need for integrative approaches to innovation and sustainability, as well as highlighting a number of innovative initiatives within the College of Engineering.
• James Wilsdon – Director of the Royal Society Science Policy Centre – gave a wonderful talk on technology innovation, going back to controversies over lightening rods in the 1700′s and highlighting how similar many of the issues we face today are to those society was facing three hundred years ago.
• Rodrigo Martinez and Mark Jones from the design company IDEO led delegates in a great team exercise in approaching challenges from different perspectives. I was particularly pleased with this session, as it demonstrated how design-inspired methodologies can be used to enable cross-expertise and innovative exploration of complex challenges.
• A panel of students and young professionals provided candid and insightful feedback on the first day’s proceedings – asking the questions and making the observations that more seasoned delegates were dying to ask and make, but were too scared to!  A number of people commenting that it was the best session of the day.

With the exception of the IDEO session, all of these talks will be available on Vimeo soon – along with the rest of the discussion panels.

All in all, it seemed to be a highly successful meeting – although I still have a pile of evaluation forms that I haven’t dared look at yet.  There were things that I would do differently next time – information overload was a major issue this year, and I’m not sure that giving myself so many panels to moderate was a great idea.  But in terms of exposing people to new ideas and sparking new insights, things seened to go pretty well.

Hopefully now, some of those sparks will catch light and grow.

Further information on the symposium can be found here.

The full set of photos from the symposium can be viewed on Flickr.

Videos of keynotes and panel discussions will be available on Vimeo shortly.

]]> http://2020science.org/2011/09/24/emerging-technologies-and-sustainability-whats-risk-got-to-do-with-it/feed/ 1 http://2020science.org/2011/08/09/what-was-worrying-us-about-nanotechnology-safety-seven-years-ago/ http://2020science.org/2011/08/09/what-was-worrying-us-about-nanotechnology-safety-seven-years-ago/#comments Tue, 09 Aug 2011 21:07:28 +0000 Andrew Maynard http://2020science.org/?p=4324

In 2004, the first International Symposium on Occupational Health Implications of Nanomaterials was held in Buxton in the UK.  Seven years later, I’m preparing for a discussion panel at the fifth meeting in this very successful community-led series (being held this week in Boston MA), and looking through the research recommendations we made at the Buxton meeting.  Disturbingly, they look remarkably similar to recommendations still being made.

The report from that original meeting can be found here, although I have also reproduced the research recommendations from that report below.  As there are a rather lot of recommendations (and I need to cover these in some rational way in this Friday’s discussion panel), I thought it would be interesting to filter them through the Wordle Creator.

This is what I got:

Of course things have moved along a lot in some areas over the past few years, and in some cases priorities have changed and new priorities have arisen.  But looking at the – admittedly qualitative – Wordle, it’s remarkable how many of these old issues remain contemporary issues.

So are we making progress, or are we simply going round in circles?  This is what I hope to tease out of my panel of experts this Friday!

In the meantime, here are the research/action recommendations we made back in 2004:

6.2 RECOMMENDATIONS FOR FILLING GAPS IN KNOWLEDGE

The following recommendations were made within the workshops addressing current knowledge gaps in understanding the potential health implications of nanotechnology in the workplace. Inclusion in this report does not constitute endorsement by NIOSH and HSE

6.2.1 Measurement of exposure to nanoparticles

1. there needs to be internationally agreed definitions of the particles that we should be measuring to assess exposure.

2. the health-related importance of agglomerated nanoparticles as opposed to single discrete nanoparticles should be addressed to ensure that measurements include all particles that may have health effects.

3. further research is needed to define the biologically relevant parameters that should be measured.

4. until more is known about which parameters should be measured, it is recommended that multiple parameters should be measured in parallel, if possible. Information is then gained about relationships between parameters to allow links with past exposure data.

5. simple, relatively cheap personal monitors for measuring exposure to nanoparticles should be developed. These should be for particle surface area or number as they are likely to be the most biologically relevant parameters.

6. as a crude identification of nanoaerosol emissions, the measurement of particle number concentrations using a hand-held CPC is considered to be useful as a process control tool.

7. strategies for differentiating between new engineered nanoparticles and ambient combustion-derived nanoparticles should be developed.

6.2.2 Control of exposure to nanoparticles

1. the effectiveness of engineering control methods, such as containment, local exhaust ventilation (LEV) systems, etc., in controlling exposure to nanoparticles should be assessed.

2. the efficiency of HEPA filtration systems used in extraction equipment fitted to LEV system (especially where the air is recirculated) and vacuum cleaners should be assessed for nanoparticles. The integrity of seals is particularly important.

3. research and development should be carried out to improve the control of exposure to nanoparticles during breakdown, maintenance and clean up procedures.

4. the propensity for powdered nanomaterials to release nanostructured particles into the air should be assessed. The usefulness of current methods of dustiness testing for nanomaterials should be investigated.

5. mechanisms should be put in place to enable good control practice for nanoparticles to be shared between companies and industry sectors.

6. the efficiency of respiratory protection equipment for minimising exposure to nanoparticles should be investigated, especially in terms of face-seal leakage and for very small particles (< 5nm).

7. the penetration of nanoparticles through skin protection equipment (gloves, boiler suits, etc) should be investigated.

6.2.3 Mechanisms underlying toxicity of nanoparticles

1. the possible mechanisms by which engineered nanoparticles have the potential to translocate through the body and to affect cells in host organs should be further investigated at the molecular level.

2. the effect of the state of aggregation on the toxicity of nanoparticles should be investigated.

3. work should be carried out to determine the relative contributions to adverse health effects of the generic size of the nanoparticle and the role of surface chemistry including any agent that it may carry.

4. relevant test methods should be developed to investigate the genotoxic hazards and risks of nanoparticles in their various applications.

5. it was suggested that OELs exposure limits are still set on a mass basis as well as on data including surface area and particle number.

6. screening methods should be developed for new nanoparticles that are based on biochemical mechanisms and susceptible targets.

7. existing data on toxicity of other particulate materials should be used for comparison of hazards.

8. more relevant (in-vivo) screening methods should be used to assess potential mutagenicity of nanoparticles.

6.2.4 Human experience in exposure to nanoparticles

1. a multidisciplinary approach was necessary to investigate the health effects of nanoparticles, including toxicological mechanisms of action.

2. an agreed definition of nanomaterials and nanoparticles is required.

3. an agreed exposure metric is required.

4. development of practical devices which, with development of agreed exposure measurement techniques, would enable reliable measurement of workplace exposures to nanoparticles is required.

5. no agreed health surveillance approaches were identified.

6.3 RECOMMENDATIONS FOR REGULATORY ACTION ON THE CONTROL OF EXPOSURE TO NANOMATERIALS

The views and recommendations expressed in this section are solely those of the workshop participants in the First International Symposium on Nanotechnology and Occupational Health. Inclusion in this document does not constitute endorsement by NIOSH or HSE.

6.3.1 Regulations for nanomaterials

When occupational health and safety regulatory authorities review the adequacy of their regulations with respect to nanomaterials the following issues should be considered:

1. determine the number of people exposed and at what levels;

2. evaluate whether mass-based exposure limits are adequate;

3. investigate what measurement methods are available;

4. review adequacy of personal protection equipment for nanoparticles;

5. determine if there are any susceptible groups in the workforce;

6. evaluate whether a “skin” notation is needed;

7. consider the adequacy of labelling and of the material safety data sheets;

8. evaluate whether nano-forms of a material should be considered to be a new substance (as in Notification of New Substances [NONS] regulations);

9. develop a framework to categorise or group nanomaterials for hazard classification and exposure limits;

10. recommend interim measures and generic approaches until more specific information is available on risk from nanomaterials.

The current regime was considered to provide an adequate framework for regulations with the following suggestions for improvement:

1. determine if current toxicological protocols are adequate;

2. evaluate (as an EU.-specific issue) whether current production triggers (in NONS) are suitable for nanomaterials;

3. consider establishment of new ultrafine sampling convention;

4. ensure that regulations are internationally harmonised.

6.3.2 Occupational exposure limits

1. it was concluded that there was currently insufficient data upon which to set any occupational exposure limits (OELs) for nanoparticles.

2. the one exception was nano titanium dioxide particles for which there is a reasonable data on pulmonary and dermal toxicity.

3. as a way forward to enable safe production of nanomaterials, it was recommended that best practice in controlling exposure be deployed.

In order for regulatory authorities to set OELs for nanomaterials, the following was recommended:

1. substantial research funding should be available to conduct exposure and toxicity studies on new and existing nanomaterials;

2. exposure and toxicity studies should be carried out by multidisciplinary teams;

3. consideration should be given to co-exposures, synergisms, exposure modifiers, smokers, sensitive populations;

4. animal toxicity studies should include multi-generational studies.

6.3.3 Risk assessment and exposure control

1. it was concluded that there is insufficient information to determine whether current methods to assess risk and control exposure are adequate.

2. the process of risk assessment for nanomaterials should begin with approaches used for traditional workplace exposures, treating nanomaterials as a distinct topic.

3. research on the adequacy of current methods of control should carried out as soon as possible.

4. specific recommendations for good control practice should be developed.

5. it was recommended that a hierarchy of controls specifically targeted at nanomaterials should be produced.

In order to manage the production and use of nanomaterials in a safe way the following interim measures were proposed:

1. examine and build on our knowledge about “known” categories of ultrafine particles such as diesel exhaust and welding fumes.

2. assemble specific examples of when nanoparticle risks or nanotechnology process risks are less than or greater than risks for materials or processes involving “traditional” materials.

3. take advantage of opportunities to limit occupational exposures to nanomaterials to levels that are as low a reasonably achievable.

4. develop methods to identify manufactured nanoparticles in the presence of background particles.

5. identify suitable nanomaterial surrogates for use in studies to improve instrumentation, control technology, and toxicology for nanomaterials.

6. develop and disseminate nanoparticle assessment and control strategies for small and medium enterprises (e.g., “risk management” or “control banding” toolboxes).

7. seek global harmonisation of approaches.

8. establish easily accessible databases and information sources.

9. improve the content of Material Safety Data Sheets (MSDS) and other communications.

10. maintain a sense of urgency to answer practical questions now and to establish partnerships and approaches needed to address underlying questions of risk assessment, control, and toxicity mechanisms for nanomaterials.

6.3.4 Classification of nanomaterials

1. there is a need for new nomenclature to allow nanomaterials to be clearly identified and described.

2. current nomenclature and means of describing complex materials in NONS are not sufficient for nanomaterials.

3. materials in particles less than ~100 nm were considered to behave differently than micrometer-sized particles.

4. the current regulatory system was considered to be inadequate to control exposure to nanomaterials.

5. it was recommended that in the EU, all materials under an agreed particle size (possibly < 100 nm) should be considered new materials for NONS and REACH. (delegates were split on this recommendation).

6.3.5 Risk management

1. there is no need for a new risk management paradigm when considering the production and use of nanomaterials.

but there is a need for new tools to increase understanding of each part of the current risk management paradigm. They are:

consider adopting the precautionary principle;

reduce uncertainty by increasing knowledge through science;

consider perception or risk issues such as external risk, subjective human 
experience of risk and quality of information;

understand the paucity of information on the possible long-term effects such as 
carcinogencity, foetal exposure, neurotoxicity and cardiovascular effects and on the population at risk including the workforce and susceptible groups such as children and the elderly.

The complete report from the 2004 Buxton meeting is available at www.hsl.gov.uk/media/1646/nanosymrep_final.pdf

Update 8/11/11: Link to 2004 Buxton meeting report corrected

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.

In June 2005, the chairman and CEO of DuPont, together with the President of the Environmental Defense Fund, co-authored an op-ed in the Wall Street Journal titled “Let’s Get nanotech Right”.  The piece called for broad multi-stakeholder collaborations to help identify and address potential health, safety and environmental issues arising from the development and commercialization of engineered nanomaterials.  And it laid the groundwork for one of the more significant documents to be produced on working safely with nanomaterials over the past years – the Environmental Defense-DuPont Nano Risk Framework, published in June 2007.

Good as the Nano Risk Framework was, it didn’t escape criticism at the time – some thought it was too complex and onerous; others worried that it didn’t capture the needs and perspectives of the broader manufacturing community – especially small businesses and startups.    So it’s no small deal that, nearly four years after the original framework was released, the International Standards Organization* has just published a Technical Report on nanomaterial risk evaluation that builds on the Nano Risk Framework.

ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework.  Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document.  But there have been some changes.  Whereas the second step in the Nano Risk Framework described developing three “profile lifecycles”, the ISO document simply refers to “material profiles” and integrates the need for a lifecycle approach to these profiles within the text.  The ISO report is written in a much tighter style than that of the original document, and looses some of the occasionally long-winded expositions on what should be done and why.  And the ISO document is more compact – 66 pages as opposed to 104.  But from a comparative reading, surprisingly little has been changed from the 2007 document.

The result is a clear, tightly focused and highly applicable and adaptable guide for developing strategies for evaluating and handling nanomaterials safely.  It doesn’t come cheap unfortunately – it’ll cost you 158 Swiss Francs for a copy (tempting me to write facetiously about the cost of nano-safety these days) – but for anyone having to make pragmatic decisions on working as safely as possible with engineered nanomaterials, it’s CHF 158 well spent.

The Technical Report is built around a framework of six steps:

Describe materials and applications (establishing a clear sense of the materials being evaluated and their intended uses, including collecting information on analogous materials that might be useful).

Material profiles (profiling the material’s physical and chemical properties, its inherent environmental and health hazards, and its human and environmental exposure potential, across its complete life cycle).

Evaluate risks (estimating the nature and magnitude of risks, based on the profiles established in the previous step).

Assess risk management options (Developing a plan for managing the risks identified in the previous step).

Decide, document and act (Implement a course of action, based on the evaluation of risk and risk management options, that is relevant to each stage of the material or product’s development.  This might include deciding to halt development of a product if the potential risks are deemed to outweigh the benefits, or the costs of reducing the risks to an acceptable level are prohibitive).

Review and adapt (regularly ensure that risk management systems established are working, and revise them as necessary in the light of new information).

Inherent to this framework is the need to make situation-specific decisions that are guided by the Technical Report but not necessarily prescribed by it, and the need to constantly review and revise procedures and decisions.  This built-in flexibility and adaptability makes ISO/TR 31321 a powerful tool for developing tailored nanomaterial management strategies that are responsive to new information as it becomes available.  It also presents an integrative approach to using materials safely, that deals with the need to make decisions under considerable uncertainty by blurring the line between risk assessment and risk management.

The report contains little in the way of background information, assuming that readers already know something about the challenges presented by using engineered nanomaterials safely.  Instead, it provides clear and concise advice on what to consider and options on how to proceed at each stage of the framework.  This includes providing lists of questions that help identify key pieces of useful information in evaluating and making decisions on potential risks, and the adoption of a no-nonsense writing style – the authors tell the reader what they need to know while avoiding inconsequential waffle.

All in all, this is an admirable document, removing much of the mystique of working safely with engineered nanomaterials, and providing a pragmatic and practical framework which can be applied everywhere from a research lab to a full scale production facility.  It’s a shame that it isn’t free, as it also provides a common sense perspective on nanomaterial safety that I think would be valuable to anyone with an interest in the field – not just environment, health and safety professionals.  But as a fall back there is still the original Environmental Defense Fund/DuPont framework, which after four years has lost surprisingly little of its edge.

*Update 5/27/2011 As some of you realized, there is no such organization as the “International Standards Organization” – it’s the International Organization for Standardization, or ISO (not an acronym).  A silly error on my part brought on by writing on the plane and trying to get the blog out before my laptop battery died – and one I shouldn’t have made as I’ve done my time with ISO in the past! But I decided to keep the error in, as ironically, to many readers, “ISO” or “International Organization for Standardization” won’t mean as much to them as “International Standards Organization”.

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.

Registration is now open for the 2011 Risk Science Symposium, and as I’m chairing it, I thought it worth giving a bit of a plug here.

The symposium brings together a fantastic cast of experts from very different backgrounds to explore the intersection of technology innovation and human health risk – with the aim of stimulating new thinking and ideas.

If you are grappling with emerging risk issues in industry, government, academia or the non-profit sector, this will be the place to be in September (not that I’m bias!).

A warning thought – space is limited to around 220 participants, so early registration is highly recommended.

Further details on the speakers, program and registration can be found here.

Some of the highlights include:

• An opening keynote by John Viera, Ford Motor Company Director of Sustainability Environment and Safety Engineering
• Insights from Paul Anastas, Science Advisor to the US EPA
• A UK perspective on technology innovation, risk and policy from James Wilsdon, Director of The Royal Society Science Policy Centre
• Cutting edge discussions on developments in science and technology that are pushing the boundaries of what is possible.
• Insights into emerging risk issues and innovative solutions
• A unique symposium dinner experience with designer Rodrigo Martinez from IDEO
• A chance to interact with some of the leading cross-disciplinary thought leaders on addressing emerging risk challenges.

Draft Program

Confirmed Speakers

Registration

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.

OK so this is a shameless plug for the University of Michigan Risk Science Center Unplugged series of discussions (if you’ll forgive the pun) – and specifically the live/webcast event we’re having on the health impacts of the Gulf Oil Spill on April 14.

But I actually think the series is good enough for a bit of a plug here – not that I’m bias!

Fist a confession though: I get really bored with hour-long PowerPoint presentations and talking head monologues (sometimes, even when I’m the speaker!).  More significantly, I think there are better ways of exploring contemporary issues than just watching a series of slides and listening to someone drone on.  So when we were thinking about a format for the Risk Science Center to start tackling knotty human health risk-related issues, we tried to come up with something a little different.  The thought process went something like this:

• Lets ditch slides, because they’re tedious.
• And while we’re at it, let’s avoid long expositions from dull speakers.
• Rather, why don’t we get a bunch of experts from different perspectives to discuss issues candidly…
• …in a way that’s engaging to a wide range of people…
• …with the opportunity for the audience to throw their questions into the mix…
• …and with a strong moderator to keep things on track and stop them getting boring.
• And why not make things web-interactive – with on-line resources, questions and answers, video streaming, ever a Twitter hookup?

The result was the Risk Science Unplugged Presents… series – interesting people talking about interesting stuff, without the hassles of PowerPoint.  And fully web-interactive, so that people can watch and participate, even if they are not in Ann Arbor.

I’m rather excited about the series – but then I guess I would be.  Our first one was on nanotechnology.  The next – coming up on April 14 (10 – 11 am Eastern Time) is on the human health impacts of the Gulf Oil spill – and we have a stellar lineup, including:

• The deputy Director for Program from NIOSH,
• a PI on the recently launched NIEHS GuLF STUDY,
• an MD
• and an environmental lawyer.

So please check out the series, and join us if you can on the 14th – either in person, or via the webcast.  And please spread the word around – come September we will be kicking off a new series of Unplugged events.

And just to make things as easy as possible for you, there are the key links:

• Gulf Oil Unplugged
• Webcast (live on the 14th, archived after that)
• Twitter feed (posts with the hashtag #umrscup appear here)
• Q&A (post a comment, ask a question – you know you want to!)
• Additional resources

Enjoy!

As anyone who has followed my work over the past few years will know, I have a deep interest in the potential benefits and risks associated with emerging technologies, and in particular whether we can swing the balance towards benefits by thinking more innovatively about risk and how we address it. So it’s not surprising that I’m extremely excited to be chairing this year’s Risk Science Symposium at the University of Michigan, which is all about how we can think differently about human health risk to support sustainable technology innovation.

The symposium is shaping up to be a unique event, and one that I hope will expose participants to new ideas as well as energizing them to explore new possibilities as they work toward developing responsible and sustainable products based on technology innovations.

Over the next few weeks, we’ll be firming up the program in time for early registration, opening on April 4.

Something I’m particularly excited about is that the symposium is turning out to be a great opportunity to explore some different formats for getting people to think differently about common challenges. Rather than use the tried and tested – but often bum-numbingly boring – “talking heads” lecture format, we will be basing most of the proceedings on a series of moderated discussions. These will be designed to engage experts from different perspectives – as well as other participants – in addressing key questions, under the guiding hand of a strong moderator.

It’s a format that one colleague described as “symposium speed-dating” – but I think it’s one that will encourage new ideas and insights, and lead to some extremely engaging exchanges. And in case you think that these will go the way of many panel discussions where participants simply use their time (and that of their fellow-speakers often) as a soap box for their own ideas, think again. We’ll be working hard to ensure that this doesn’t happen. Rather, the panels will be similar to those in the Risk Science Center Unplugged series of discussions – experts from different perspectives engaged in candid, animated yet carefully directed conversation.

And what about the the content?

Day one will lay the groundwork of why technology innovation is important, explore critical areas of technology innovation that are closely intertwined with questions over human health impacts, and begin to unpack why we need to think differently about risk and how we handle it if these technologies are to succeed.

Day two goes on to considering more closely the challenges of taking an integrative approach to addressing potential human health risks associated with technology innovation, and how new thinking on risk can increase the long-term success of technology innovation.

And in between the two days, we have what is shaping up to be a rather unique and definitely no-to-be-missed dinner event. But more on that another time.

Involved in the symposium will be leading experts from industry, government, academia, civil society, the media and other groups – all challenging and inspiring each other and the symposium participants to take a new look at how thinking differently about risk can support sustainable technology innovation.

Over the next few weeks, I’ll be posting a series of blogs on the symposium. But in the meantime, you can check out the details on the symposium website, and follow progress on the Risk Science Center Facebook page.

And remember, early registration for the symposium opens April 4 – but be forewarned, space is limited.

Cross-posted from the Risk Science Blog

Back in December 2009, I rode the Acela Express up to New York from Washington DC for the day to record one of a series of nanotechnology podcasts for the ASME – the American Society of Mechanical Engineers. The podcast was to be part of a new educational outreach initiative on all aspects of nanotechnology developed by the society.

That podcast – which deals with environmental, health and safety aspects of nanotechnology – has now been published. Together with a continuing series of nanotech audio and video podcasts, it can be seen on ASME’s Nanotechnology Institute website. You’ll have to register to watch and download the podcasts – but registration is free.

However, the good folk at ASME have also allowed me to post the podcast here:

A product of 4 grueling hours of filming (for four minutes of footage!!), I thought the editing and production team did a great job of pulling something coherent, informative and engaging together.  It should be obvious by the way where the real talent lay here by comparing the length of the filming session to the length of the final video!

If you find this interesting, you should check out other podcasts in the series, which currently cover energy, materials, the life sciences, and environment, health and safety.

ps – there is one juxtaposition of images in the podcast that I thought was rather strange – brownie points to anyone who can spot it!

Cross-posted from the Risk Science Blog.

As it did last year, the World Economic Forum Annual Meeting in Davos has left me with a daunting task – how do I summarize the highlights of the meeting in a single, short post?

The answer of course is that I can’t – Davos is so complex, diverse and multi-layered that no single account could do it justice. But sitting here waiting for the flight home, I wanted to capture at least something of the past few days.

World Leaders – world issues

This year saw the usual parade of world-leaders passing through Davos, selling their wares in public, while cutting deals in private.

In public and private, the unfolding events in North Africa, the Moscow terrorist attack and the world economy dominated discussions.

As is fairly typical at Davos, not too much that was startling or new was announced in public. But this is a meeting where off the record meetings and encounters are everything. And given the isolation, camaraderie and personal access that pervades Davos, the barriers to meaningful exchanges are perhaps lower here than at almost any other gathering of the great and good.

As one person pointed out to me – many delegates simply cannot afford to bring their usual entourage, meaning that the chances of conversations that get to the heart of issues – rather than leading a carefully choreographed dance around them – are reasonably high. And of course this is further enabled by the many social occasions that smooth the way for serious conversations.

Business leaders – revealed values. This stripping away of the buffers between public personas and the people behind them is one aspect of Davos that continues to fascinate me. It’s one of the few places I know if where you can get a sense of who someone really is, not who the PR machinery tries to convince you they are (again, because most people end up having to leave the PR machinery at the door). And no-where do I find this more revealing than in talking with business leaders.

It may be because the World Economic Forum actively develops partnerships with organizations that share its commitment to improving the state of the world, but I’m encouraged by the number of high profile CEO’s and business leaders I speak with here who are motivated by far more than bottom-line dollars. A cynic might claim that it’s all part of the PR machinery, which managed to sneak past the barriers. But I don’t think it is. There’s no need for these people to spend a week of their busy schedule talking about how to make the word a better place – and what excites and inspires them – unless they really mean it.

Davos provides a rare glimpse of the idealists still alive and beating in these world-wise corporate leaders. Of course, talk is a lot easier (and cheaper) than action, and these people have to deal with colleagues, shareholders, stakeholders and an economic landscape that doesn’t necessarily allow their true values and passions to flourish . But I suspect that one of the “positive dangers” of Davos is that, having revealed their inner-self to others who have the capacity to fan the flames, many business leaders emerge just that little more motivated to look beyond the bottom line, and toward changing the world for the better.

Global risks – global opportunities

This year, global risks were a central theme of the Davos meeting. The World Economic Forum formally launched the new Risk Response Network, and risk permeated many of the sessions. The aim is to establish resources and mechanisms to respond to emerging global risks more effectively than in the past – whether they are associated with natural disasters, social collapse, financial melt-down or technological failure.

While most of the discussions revolved around avoiding risk or managing the consequences, there were a few that touched on actively mitigating risk – and supporting global economic and social growth through new approaches to risk. These included developing the means to actively reduce risks through technological, policy and social mechanisms. But they also included the need to increase resilience within global institutions, infrastructure and communities – so that when things go wrong, the system can respond and adapt quickly and effectively.

This need for resilience was highlighted in a final session on global risk I was participating in, as we considered what lessons can be learned from events in Tunisia and Egypt on our dependence on and the fragility of the internet.

Science and technology – more than entertainment

Science and technology were more prominent than usual at this year’s meeting. There were packed-out sessions on the current state of science, and on contemporary issues such as the nature of the universe and personalized medicine. Yet there was still a sense that this was entertainment for delegates – a light distraction from the serious business of putting the world right, and something for accompanying partners to attend.

Nevertheless, there were indications that this is changing. The World Economic Forum has established a science advisory council that will be looking at how science can be better-integrated into the program in future years. A number of conversations I had with scientists and technologists – and there were a surprising number of them at the meeting – revolved around their desire to see science and technology rise up the agenda. And business leaders like Ellen Kullman – CEO of DuPont – were vocal about the need to pay more attention to technology innovation in building a better world.

As this is one of the aims of the Global Agenda Council I chair, it was good to see the beginnings of a groundswell toward shifting from science and technology as the Davos entertainment, to making them a significant part of broader discussions on building a sustainable future.

Social media – WEF goes grass-roots?

The use of social media was huge at this year’s meeting.

I’m not sure whether the impact is there yet – that will come – but content generation was significantly higher than previous years. Over 400 delegates were tweeting from the meeting, providing real-time insight into proceedings. Delegates were also encouraged to record short YouTube videos responding to questions posed by members of the public – and many did (including a number of prominent participants). Many delegates contributed guest blogs to the WEF blog, providing further insight into the meeting. And FaceBook marketing director Randi Zuckerberg (sister of Mark) conducted livestream webcast interviews with everyone from Tony Blair to Bill Gates to Bono.

Having seen social media in action at this year’s meeting, I’m convinced that this is the beginning of a powerful outreach and engagement by WEF that breaks the established boundaries of the organization – watch this space!

Real lives – strong inspiration

There are numerous misconceptions about Davos – many of them characterizing it as a meeting where gray men in gray suits with gray imaginations get together to schmooze with other, equally gray men, usually with no appreciable outcome. But as anyone who has been a part of the meeting can attest to, this is about as far from the truth as you can get.

At the heart of Davos is a common desire to change the world for the better. Invited participants are carefully selected according to what they do – not just who they are (even the celebrities are here because of the initiatives they are involved in, rather than the star status attached to them. And paying participants are carefully filtered and cultured to encourage a meeting where common values permeate the conversations.

This is perhaps best summed up in this year’s closing session, where Klaus Schwab, the Executive Chairman of WEF, spoke with Christine Lagarde, the French Minister of Economy, Nick Vujicic, President of Life without Limbs, and two of the Davos Global ChangeMakers – Raquel Silva and Dan Cullum.

The topic was “Inspired for a lifetime”. Unusually for a meeting characterized as full of “gray men”, there was hardly a dry eye in the house. (you wouldn’t have known at the time, but I’ve yet to speak to someone who was there who didn’t admit to tearing up at times). But I’m convinced that this wasn’t because of an overtly emotional program – it was simply because the delegates recognized in the panelists a common desire to act to make the world a better place.

Without the context of the preceding four days, the session might have come across as overly sentimental. But with the weight of Davos behind it, it was grounded in a reality that transcended mere sentimentality.

But don’t just take my word for it – the closing session of Davos 2011 can be viewed below.

Cross-posted from the Risk Science Blog.

Take a metaphorical slice through this year’s annual World Economic Forum meeting in Davos, and Global Risk would be writ large through every part of it.  Hot on the heels of the sixth Global Risk report, this year’s meeting saw the launch of the Risk Response Network – a new initiative to facilitate responsive, informed and integrative action on global risks.  And throughout the meeting, sessions and conversations abound that are grappling with understanding and mitigating emerging risks in today’s complex and interconnected world.

But important and impressive as this agenda is, I wonder whether there is something missing.

I’m approaching risk at Davos this year from three perspectives: exploring the relationship between science, innovation and risk; understanding the impact of emerging risks on public health; and developing technology-enabled approaches to risk mitigation.  The common themes here are science and technology – both as potential drivers of risk, and as sources of possible solutions.

From my work in science, technology and public health, it is clear that a deep understanding of the roles of science and technology in addressing risk is critical to building resilient and sustainable responses to global risks.  It is also increasingly clear that integrating this understanding into the process of addressing global risks is vital.

Yet this is where the World Economic Forum’s timely thrust to address global risks seems to be somewhat lacking.

Science and technology are certainly well-repented on the Davos agenda.  But I get the sense that they are part of the alternative program – “the entertainment” as one colleague described them.  This is probably a little harsh.  But the science and technology sessions do tend to be aimed at wowing delegates, rather than engaging them in exploring integrated solutions to pressing problems – a bit of light relief from the serious business of fixing the world’s problems.  Even the IdeasLab sessions, which get the closest to engaging people on emerging issues, struggle to make science and technology part of a larger conversation.

Don’t get me wrong – I’m the first to admit that there’s a lot to get excited about in contemporary science and technology.  But if robust solutions are to be found to global risks, science and technology must be integrated into mainstream discussions – not treated as an entertaining but often incomprehensible sideshow.

And that means elevating science to a seat at the table as new solutions to emerging risks are explored.

I realize that this is a daunting task. I’ll be the first to admit that scientists can be an intimidating bunch – an image they don’t necessarily try too hard to dispel.  But until scientists, engineers and technologists are seen as partners in the process of risk mitigation, not just  consultants or contractors, building resilient solutions to global challenges is going to be one tough call.

Cross posted from the Risk Science Center Blog:

There’s a lot to like in President Obama’s perspective on 21st century regulation. Writing in today’s Wall Street Journal, Obama outlines his thinking behind his new executive order to review and revise a convoluted and potentially disruptive federal regulatory system. But if regulation in the 21st century is to be effective in protecting people and enabling economic growth, it needs to become more sophisticated and innovative, while avoiding the traps of over-simplistic thinking.

I’m glad Obama puts a strong emphasis on public health in his op ed. It’s all too easy easy for these conversations to degenerate into regulatory bashing in favor of business freedom – a trap Obama deftly avoids. Yet he is spot on when he calls out the dangers of out-dated and ill-conceived regulations potentially stifling innovation and economic growth – an outcome which ultimately also impacts on public health, albeit in less directly measurable ways.

The trick is to find that sweet spot between preventing harm while supporting the economy.

As society and the technologies it relies on become ever-more complex, finding this sweet spot is becoming increasingly difficult. New technologies are spawning new products that cause harm in new and sometimes unanticipated ways. An ever more interconnected global society is eroding traditional command-and-control oversight frameworks. And a growing flood of tantalizing yet often incomplete data is creating confusion over what is safe, and what is not.

Yet the same changes that are making old-style regulation increasingly difficult are also opening up opportunities for innovation in how we protect people. Group-sourcing expertise and perspectives in new ways can help craft more responsive regulation. Novel approaches to collecting and analyzing information are able to offer new insights into balancing safe and profitable practices. New approaches to science and engineering are beginning to push risk management up the innovation chain – engineering risk out of products from the get-go. And new technologies are delivering new ways to evaluate and manage potential risks.

As well as cutting out the dead wood from the existing system, 21st century regulation also needs to innovate and take advantage of these opportunities. This will bring us closer to finding that sweet spot where both safety and economic success are achieved. But to achieve it, we will have to be increasingly sophisticated about how we think about risk and regulation.

It’s all to easy to over-react to potential risks, and to push for action based on gut instincts rather than clear evidence. This is why formal regulation starts with evidence-informed decision-making, rather than instinct and assumption. But there is also a danger of the pendulum swingging the other way, and instinctive assumptions leading to inadequate regulation.

Although the point was well-made, I must confess to being a little concerned by Obama’s comment on saccharin when he stated that “if it goes in your coffee, it is not hazardous waste”. When it comes to risk, dose and context are everything – what is good in moderation in one place can be deadly if present in excess in another. Saccharin is now widely acknowledged as safe for human consumption – hence Obama’s quip. But it won’t always be the case that what is good in small quantities is also good when dumped by the ton in the environment – especially if it has potential long-term, environmental or trans-generational impacts.

Rather than rely on over-simplistic assumptions on risk, we need now more than ever to develop sophisticated, evidence-informed yet socially, economically and politically responsive approaches to human health risks. This is at the heart of risk science, where evidence and understanding drive the process of reducing risks.

Hopefully it will also be at the heart of US regulatory reform, as we continue to strive for the sweet spot between safety and success.

- all to often, these conversations emphasize the need to prevent regulation interfering with business concerns. Obama on the other hand places human health high on the agenda. But at the same time he acknowledges the importance of good regulation in

A few weeks ago, I gave a talk at the Contemporary Arts Center in Cincinnati under the slightly provocative title “Small Gods and the Art of Technology Innovation”.  The talk is now available on-line (slides and audio at least) – and viewable below – through the excellent work of the folk at CAC.

Rather sneakily, I used the opportunity to talk to a (mainly) lay audience about risk science in the 21st century – did I get away with it I wonder…?

I’m feeling a little lazy today, so this is a cross-posting from the University of Michigan Risk Science Center newsletter.  It draws in part on the talk I gave at the Cincinnati Contemporary Arts Center this past weekend as part of their “where do we go from here?” series.  The whole setup at CAC by the way was excellent – engaged audience, great space, and wonderful staff.

Slow exposure of a complex pendulum, used to illustrate the challenges of addressing risks in a technology-dependent and integrated world.

In early December, I found myself in the bizarre position of giving a public lecture on risk science at the Cincinnati Contemporary Arts Center. Despite the seemingly strange juxtaposition of art, risk and science, together with my wife’s admonitions of “what do you know about art anyway?!” it was an immensely gratifying event – not least because it forced me to think about what risk science means to people who aren’t in the risk business.

The question of what risk science is was one that I had tackled a couple of weeks previously at the inaugural Charles and Rita Gelman Risk Science Professorship lecture. Here, I argued that in a complex world, blindly following our instincts can actually increase the chances of people being harmed. What we need is a systematic and unbiased way of addressing human health risks. Science provides a great solution here – by focusing on prediction, evidence and correction, it factors human foibles out of the decision-making process; at least in principle.    Hence “risk science” as a basis for evidence-driven decision-making.

But then I asked – is this vision of risk science enough to keep us healthy, wealthy and wise in the 21st century? The answer was no. Hard data are clearly critical to informed decision-making. But the numbers just aren’t aren’t enough when it comes to making decisions within increasingly complex and highly interconnected systems. In today’s society, we also need to understand and respond to a whole host of other factors that influence the effects associated with certain courses of action. In other words, if we are to make effective decisions on human health risks in the 21st century, our concept of “science” in “risk science” needs to expand to cover expertise in the social, economic and political sciences and beyond.

As you might imagine, this was the starting point for some interesting conversations at the Contemporary Arts Center. And one that particularly intrigued me was the question of how you help people make good decisions on risk in the face of all this complexity and interconnectedness? How do you forge connections between people that increase the chances of them making evidence- based and socially-responsive decision-making? One of the answers was – unsurprisingly given the setting – through art. Where facts fail, art enables connections to be made and understanding to flow between people in ways that circumvent our struggle to make sense of cold numbers.

Which begs the question – is “risk science” broad enough to embrace the arts as well, or do we need to start thinking about a complimentary field of “risk arts?”

The Risk Science Center newsletter with the original piece can be read here.

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!

In an interconnected world, global issues demand integrative solutions.  It’s a statement that many people would agree with – in systems where associations between cause and effect are complex, you ignore synergistic inter-relationships between factors at your peril.

But when it comes to technology innovation, it seems that the rules don’t apply.

This week I am at the World Economic Forum Global Agenda Councils meeting in Dubai – I’m chairing the Council on Emerging Technologies.   Our task is deceptively simple: How do we as a society ensure emerging technologies support responsive, sustainable and resilient solutions to global issues, without them leading to new problems? But as we are learning, finding answers is not easy.  And the first hurdle we face is convincing people of the need to think holistically about emerging technologies.

It seems that all too often, for all the talk of integrative solutions to global issues, when it comes to technology innovation integration is the last thing on people’s minds.

I was forcibly reminded of the uphill struggle we face this afternoon, listening to BBC World News presenter Nik Gowing.  Gowing was moderating a debate on natural resource scarcity, to be broadcast on the BBC World Service in a few days’ time.  The debate addressed a specific question: As global population rises toward 9 billion people and the demand for natural resources such as water, food, oil and minerals increases, how do we meet the challenge of making diminishing resources go further?  On the panel were Louise Arbour, President and Chief Executive Officer of the International Crisis Group (ICG); James Cameron, Vice-chairman of Climate Change Capital; He Yafel, Ambassador and Permanent Representative of the People’s Republic of China to the United Nations; Malini Mehra, Founder and Chief Executive Officer of the Center for Social Markets (CSM) and Kevin Rudd, Australian Minister of Foreign Affairs.

I was interested to see how systemic the panel’s thinking was on potential solutions, and in particular what their take was on the role of technology innovation.  So I was just a little surprised when the “technology count” – the number of times that technology was raised as part of the solution to dwindling resources – came out as a resounding zero.  This was a discussion on issues that are deeply influenced by technology innovation, which revolved exclusively around social, political and economic perspectives.

I was left wondering whether technology was not on the table simply because it is seen as too complex, or whether there was a naive assumption that, as crises arise, scientists and engineers will simply pull a metaphorical white rabbit out of their technology magic hat.

To be fair, the debate was specifically framed in terms of social, political and economic drivers.  But I have to wonder: if integrative solutions are the key to complex and interdependent issues like resource depletion, how can we ensure that technology innovation is part of the conversation, rather than a somewhat optimistic bolt-on?

This concern is fueled by many similar experiences, and is one reason why raising awareness of the need to integrate an understanding of emerging technologies into dialogues on a multitude of global issues is high on the Council on Emerging Technologies’ agenda.

And no-where is this more important than in responses to global risks. As society faces new systemic risks, emerging technologies have three key roles to play.  They can provide tools that enable emergent risks to be monitored, tracked and better-understood; they offer potential solutions to addressing emerging issues; and they can act as agents of change which may lead to a dramatically altered risk-landscape.  But for the positive potential that is nascent in emerging technologies to be realized, integrative approaches to their development are essential.  The danger of neglecting to do this is a potential failure of emerging technologies to lead to workable solutions to pressing issues.  Or worse – the emergence of technologies that instead of reducing risks, lead to greater risks.

Of course, there are many discussions taking place on how emerging technologies might solve global problems.  But they are usually separate from the social, economic and political factors that so often drive decision-making.  And in a technologically complex and interconnected world, this is a recipe for disaster.

In moving forward, emerging technologies need to be brought in from the cold.  They need to be moved up the global agenda.  And they need to take their place alongside social, economic and policy factors in crafting integrative solutions to interconnected issues.  Because the one thing we can be sure of is that if we don’t take an integrative approach to emerging technologies, when we most need a technology “white rabbit,” the hat will be empty!

I should add that even though I am the chair of the Emerging Technologies Council, these are my own views, and do not necessarily reflect those of the council.

Quick update 11/30/10: Tim Harper – fellow Council member – has just posted this helpful piece on the definition of emerging technologies: http://cientifica.eu/blog/2010/11/the-long-journey-from-nanotechnology-to-emerging-technologies/

As Director of the University of Michigan Risk Science Center, it’s probably not surprising that I’m constantly being asked “what on earth is risk science?”  What is surprising is how hard it is to come up with a clear and concise answer.  Which is why I decided to spend a good portion of my “installation” lecture the other week developing the idea of what I think of as being Risk Science.

As the lecture is now available on-line, I thought it worth posting a link to it just in case anyone is interested. But with a huge caveat – the sound quality is abysmal!

Ironically – as the Risk Science Center is very much focused on communication – this is a great example of how not to use on-line videos of lectures to communicate.  In fact, if it wasn’t for the fact that there’s some useful content here, I would bury the video out of shame, and pretend that it never existed.

The AV folk are going to try and clean the sound up (good luck to them!), and if they succeed, I might think about chopping this up into more accessible chunks.  But for now, on the assumption that there may be one person at least out there who might find this of use, here’s the link:

Building a Sustainable Future – The Role of Risk Science

The interesting stuff begins around five minutes in by the way, after all the pomp and ceremony.

And just in case you are interested in a more accessible account of my perspective on risk science, I was pleased with Gwyneth Shaw’s recent write-up in the New Haven Independent, under the headline A Call For Stepping Up “Risk Science”

(The PDF of the slides associated with the lecture are available here, but I’m not sure how useful they are without the accompanying narrative)

]]> http://2020science.org/2010/11/28/risk-science-a-personal-perspective/feed/ 3 http://2020science.org/2010/11/21/risk-uncertainty-and-sustainable-innovation-feedback-sought-on-symposium-blurb/ http://2020science.org/2010/11/21/risk-uncertainty-and-sustainable-innovation-feedback-sought-on-symposium-blurb/#comments Sun, 21 Nov 2010 18:11:24 +0000 Andrew Maynard http://2020science.org/?p=3837

Despite the risk of receiving absolutely no comments (please don’t let me down!), I thought I’d try something new and ask for some feedback on the background blurb for a meeting I’ve been working on.

The meeting is a symposium on Risk, Uncertainty and Sustainable Innovation being organized by the Risk Science center next September.  I’ve been struggling with the blurb for this meeting before it goes out – especially striking the balance between something that captures the imagination (and hopefully the attention) of potential speakers, sponsors and attendees, and something that has clarity and substance.

The text below is my latest draft.  What I would love to know – today ideally (knowing that you all are desperate for something to break the boredom of a Sunday afternoon) – is whether in your opinion this works, whether it is fluff without substance, whether it is the perfect insomnia cure, or whatever.

Please, please add your comments below – no matter how brief, or how qualified/unqualified you feel you are to say something.

Thank you!

Risk, Uncertainty and Sustainable Innovation

New perspectives on emerging challenges

As we strive to build a sustainable future, do we need to rethink the relationship between risk, uncertainty and innovation?  Today’s accelerating rate of technology innovation promises profound personal, social and economic advances. But in an ever-more complex, interconnected and resource-constrained world, sustainable innovation is jeopardized by emergent risks, together with increasing uncertainty over potential benefits and impacts.  And no-where is this more apparent than at the intersection between technology innovation and human health.  Drawing on thought-leaders from a wide range of backgrounds and expertise, this symposium provides a unique forum for exploring new ideas on integrative approaches to health risks, uncertainty and innovation, as we look to develop sustainable solutions to global challenges.

Background: As technologies become more sophisticated, pressures on global resources grow and society becomes ever-more interconnected, governments, businesses and citizens are facing increasingly complex challenges as they strive to build an economically, socially and environmentally sustainable future. Over the past century, technology innovation has accelerated to the point where scientists and engineers have greater control over materials, organisms and systems – from the atomic scale to the planetary scale – that ever before.  This has facilitated a radical shift in global communication, leading to an interconnected society where the flow of information, ideas and influence transcends geographical, economic and social boundaries.  At the same time, a growing and increasingly plugged-in world population is placing unprecedented demands on ever-scarcer global resources.

The result is a world where innovation is both a driver of and a potential source of solutions to an increasing number of emerging global challenges.

If we are to adapt and thrive in this changing world, we urgently need to better-enable sustainable innovation – the sustainable development of relevant and responsive new understanding, processes and products that support long-term advances in the quality of human life and the environment.  Yet sustainable innovation is inextricably intertwined with risk – particularly the danger of causing harm to human health – and uncertainty over the consequences of our actions.

Technology innovation leads to emergent risks – the likelihood of causing harm in a manner that is not apparent, assessable or manageable based on current approaches to risk assessment and management.  The more complex and rapid the innovation, the greater the chances of perceived or actual risks emerging that require new and responsive approaches to minimizing their impact.  But as a clear understanding of risks and how to manage them will always lag behind innovation, technology innovation is also dogged by uncertainty – particularly over how a specific course of action may lead to harm, and how this can be avoided.

If innovation is to support sustainable solutions to 21^st century challenges, new and integrative approaches to risk and uncertainty are required.  New insight is needed on the interplay between risk, uncertainty and sustainable innovation.  Methods of moving risk-based decision-making upstream in the innovation cycle need to be explored.  And greater understanding of is needed on enabling collaborative decisions within an increasingly interconnected society in the face of uncertainty.

These are the challenges explored in the 2011 Symposium on Risk, Uncertainty and Sustainable Innovation. Drawing on thought-leaders in industry, government, academia, the media and other sectors, the symposium will provide a unique opportunity to explore new ideas on sustainable innovation in the face of growing global challenges, emergent risks to human health, and increasing uncertainty over the potential benefits and consequences of technology innovation.

Next week I am being “installed” here at the University of Michigan.  Not in the sense of installing a carpet – as one friend suggested – but in the sense of being installed as an endowed professor.  The Charles and Rita Gelman Risk Science Professor to be precise.

To mark the occasion, I’m expected to entertain the crowds here with deep, expansive and probably incomprehensible thoughts on risk science.

Not sure I can deliver that, but here’s the ‘teaser” that was circulated on what I might be touching on:

By 2050, over nine billion people will be placing unprecedented demands on the earth’s resources – a demand that will only be met through developing and using new technologies.  But in today’s complex and interconnected world, the safety and success of technology-based solutions is by no means assured. As we strive to build a sustainable future, we need to think differently about how rapid social and technological change are leading to new risk-challenges, and how they are best addressed.  In effect, we need a new risk science for a new century. Professor Maynard will be talking about the new challenges of enabling sustainable development in a complex, interconnected and risky world.

A more accurate – but substantially more boring – account of what I’m likely to cover is given in the lecture’s abstract:

Risk is intimately intertwined with human life.  From the earliest beginnings of life, risk has been part and parcel of natural selection; forcing evolution along paths that minimize risk while maximizing benefits.

Risk has by turns stimulated and limited our own achievements as a species for thousands of years.  In fact everything we do – or don’t do – as individuals and as a society has the potential to lead to beneficial or adverse consequences.  So it’s not surprising that we have evolved sharp instincts for dealing with possible risks.

These instincts have served us well in the past. But they have proven increasingly unreliable as we have become ever more reliant on complex technologies.  To overcome these limitations, we have turned to science as a means of developing systematic and evidence-based approaches risks that aren’t compromised by human vagaries.  The resulting “risk science” – built on sound scientific principles – has supported the rapid development of many significant technologies over the past hundred years.  But heading into the 21st century, it is increasingly doubtful whether this “old” risk science will continue provide the necessary support to build a sustainable future.

We are entering a unique time in humanity’s history:  We face a future dominated by complex and rapidly developing technologies; unprecedented global interconnectedness; and dwindling natural resources.  These three factors are converging to shake up not only the challenges and opportunities we face as a global society, but also the very methodologies we use to get to where we need to be.  As we embrace this future, we will need a “new” risk science – one that draws on “science” in the broadest possible sense to enable evidence-informed and socially-responsive decision-making in an increasingly complex and interconnected world.

Whatever I end up saying, I’m toying around with some new presentation techniques for the talk.  These might work, or they might bomb – either way, it should be entertaining for the audience, if not for me!

The lecture is being held between 3:30 PM – 4:30 PM on Wednesday November 17 in the University of Michigan School of Public Health – feel free to drop in if you are in the area.  There’s a reception afterward – which is never a bad thing!

]]> http://2020science.org/2010/11/12/lost-in-the-maize-9/feed/ 8 http://2020science.org/2010/11/08/tenure-track-faculty-positions-in-risk-science-at-the-university-of-michigan/ http://2020science.org/2010/11/08/tenure-track-faculty-positions-in-risk-science-at-the-university-of-michigan/#comments Mon, 08 Nov 2010 19:20:25 +0000 Andrew Maynard http://2020science.org/?p=3802

Just thought I’d circulate this on the 2020 Science network – please feel free to pass on the information to anyone who might be interested.

We have finally started the process of looking for two junior faculty to join the Risk Science Center at the University of Michigan School of Public Health.  This is an exciting opportunity for two people to join the Center as it develops its vision and mission, and to have a significant role in helping build it up as an internationally recognized cross-disciplinary center of excellence dedicated to fostering new thinking, new understanding and new tools to support evidence-informed and socially relevant decisions on both emergent and extant risks to public health.

Full details on the position, qualifications and the application process can be found here.  We’ll be starting to review applications on December 1, although the positions will remain open until we find suitable candidates.

Now that I’ve had some time to get to grips with my new position as Director of the University of Michigan Risk Science Center, I thought it was high time I started letting people know something about where the Center will be heading over the next few years.  Cross-posted on the Risk Science Center’s home page, here’s a flavor of where we’re going:

Risk is often treated as a four-letter word, or an embarrassing relative – something distasteful that shouldn’t be mentioned in polite society. Yet the reality is that a clear understanding of risk and how to deal with it is essential to every aspect of our lives. The past hundred years have left us a horrifying legacy of what goes wrong when people ignore risks, or fail to identify, access and manage them appropriately, or aren’t equipped to make informed decisions as new potential issues arise. And the challenges are only going to get tougher in today’s increasingly technology-dependent, interconnected and resource-constrained world. Without a doubt, if we are to build a sustainable future in the 21st century, we need to rethink our approach to risk. We need integrative, cross-disciplinary approaches to understanding and managing risks that are inclusive of all stakeholders. We need to push the process of identifying and addressing potential risks up-stream in the innovation process. And we need to equip everyone from citizens to CEO’s and journalists to policy makers to make informed decisions in the face of increasing uncertainty and complexity.

When I accepted the directorship of the Risk Science Center earlier this year, it was this forward-looking challenge that was uppermost in my mind… We already have a strong tradition at the University of Michigan and elsewhere of assessing risks to human health through research in areas like toxicology, epidemiology and exposure, and using generated data to drive decisions on risk management and mitigation. But we struggle to deal with emergent risks presented by new technologies (or new ways of using old technologies) in a changing world. Everyone does – there is no manual (yet) for how to address human health risks from increasingly complex technologies, and how to do this in a society where stakeholder and citizen engagement is becoming increasingly important, where uncertainty dominates the decision-making process, and where ill-informed decisions on risks and benefits could be potentially catastrophic.

So my aim is for the Risk Science Center to spearhead the movement toward a new risk paradigm. By integrating cutting edge science, multi-stakeholder partnerships and effective communication, the Center will be working towards avoiding harm from existing and emerging technologies while ensuring their benefits are fully realized. It’s an approach that will significantly reduce the chances of future adverse health impacts – but it’s also one that makes sound business sense.

This is still very much a work in progress. Over the next year the governance structure of the Center will be established, it’s vision, mission, aims and activities will be further developed, and this website will undergo a major overhaul – creating a resource and community nexus for stakeholders, faculty and students engaged in thinking differently about risk.

In the meantime, please check out the Risk Science Center’s about page for further information on how the Center is developing. And keep an eye out for new initiatives coming out of the Center – including next year’s Bernstein Symposium on “Risk, Uncertainty and Sustainable Innovation: New Perspectives on Emerging Challenges”.

Risk may still be a four-letter word to some, but that’s going to have to change if we as a society are going to tackle the challenges and opportunities of the 21st century and come out on top. As the Risk Science Center develops, expect it to be front and center of this change.

For more information, check out the Risk Science Center’s website.

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!

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/2010/05/26/as-scientists-create-the-first-synthetic-cell-the-future-safety-of-synthetic-biology-will-depend-on-sound-science/ http://2020science.org/2010/05/26/as-scientists-create-the-first-synthetic-cell-the-future-safety-of-synthetic-biology-will-depend-on-sound-science/#comments Wed, 26 May 2010 15:34:34 +0000 Andrew Maynard http://2020science.org/?p=3238

Last week’s announcement from the J. Craig Venter Institute that scientists had created the first-ever synthetic cell was a profoundly significant point in human history, and marked a turning point in our quest to control the natural world.  But the ability to use this emerging technology wisely is already being dogged by fears that we have embarked down a dangerous and morally dubious path.

It’s no surprise therefore that, hot on the heels of last week’s announcement, President Obama called for an urgent study to identify appropriate ethical boundaries and minimize possible risks associated with the breakthrough.

This was a bold and important move on the part of the White House.  But its success will lie in ensuring the debate over risks in particular is based on sound science, and not sidetracked by groundless speculation.

The new “synthetic biology” epitomized by the Venter Institute’s work – in essence the ability to design new genetic code on computers and then “download” it into living organisms – heralds a new era of potentially transformative technology innovation.  As if to underline this, the US House of Representatives Committee on Energy and Commerce will be hearing testimony from Craig Venter and others on the technology’s potential on May 27th – just days after last week’s announcement.  But the technology also raises serious ethical and safety concerns: Is it right and proper to meddle with the fundamental basis of life?  What happens if the technology gets into the wrong hands? And what might occur when synthetic life meets the natural world?

Questions like these have challenged scientists, ethicists and decision makers for many years, and with good reason – our headlong charge into advanced genetic manipulation is taking us into uncharted and uncertain territory.  But the breakthroughs made by Craig Venter and his team place a new urgency on developing policies, ethics and research strategies in support of safe and acceptable synthetic biology.

The ethics in particular surrounding synthetic biology are far from clear; the ability to custom-design the genetic code that resides in and defines all living organisms challenges our very notions of what is right and what is acceptable.  Which is no doubt why President Obama wasted no time in charging the Presidential Commission for the Study of Bioethical Issues to look into the technology.

But in placing ethics so high up the agenda, my fear is that more immediate safety issues might end up being overlooked.

It’s not that safety isn’t on the radar – there is already tremendous speculation over the potential impacts of synthetic biology.  But with one or two exceptions (including work from the J. Craig Venter Institute), there seems little science behind many of these conjectures.  And actions based on speculation alone may endanger the tremendous good that could come from this rapidly emerging technology, while potentially opening the door to unintended consequences.

Rather, scientists, policy makers and developers urgently need to consider how synthetic biology might legitimately lead to people and the environment being endangered, and how this is best avoided.

What we need is a science-based dialogue on potential emergent risks that present new challenges, the plausibility of these risks leading to adverse impacts, and the magnitude and nature of the possible harm that might result.  Only then will we be able to develop a science-based foundation on which to build a safe technology.

Synthetic biology is still too young to second-guess whether artificial microbes will present new risks; whether bio-terror or bio-error will result in harmful new pathogens; or whether blinkered short-cuts will precipitate catastrophic failure. But the sheer momentum and audacity of the technology will inevitably lead to new and unusual risks emerging.

And this is precisely why the safety dialogue needs to be grounded in science now, before it becomes entrenched in speculation.

In six months’ time, the President’s Commission for the Study of Bioethical Issues will be presenting President Obama with its findings and recommendations on the implications of synthetic biology.  Hopefully as well as grappling with the ethics of nanotechnology, their recommendations will also address the potential and plausible risks associated with the technology, and the science that is needed to ensure its safe development and use.

Because without sound science guiding the safety dialogue, there is every chance that synthetic biology will be derailed by mistrust, misinformation and misunderstanding.

And if this happens, it’s hard to see how anyone can win.

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?

As many of you will have picked up from recent blogs, I am moving on from my position as Chief Science Advisor to the Project on Emerging Nanotechnologies.  From April 1, I will be taking up the post of Director of the University of Michigan Risk Science Center.  This is a tremendously exciting opportunity to lead a world-class group of researchers in supporting and enabling science-based decision-making.  It also couldn’t come at a more opportune time, as governments, businesses and citizens struggle to deal with risk and uncertainty in an increasingly complex world.

The University of Michigan Risk Science Center has been around for a while, but has been in a holding pattern for the past couple of years while a new director was recruited.  Supported by a very generous gift from Charles and Rita Gelman, the Center has already been placed on a very strong footing within the University of Michigan School of Public Health.  My aim over the next few years will be to build on this foundation – increasing the scope, activities and impact of the Center, and developing it as an international Center of Excellence.

Over the next year or so I will be developing the Center’s focus more specifically in four areas:

• Research underpinning quantitative risk assessment;
• Emergent risks – specifically the possibility of materials and products causing harm in ways that are not apparent, assessable or manageable based on the current state of knowledge;
• Innovative new ways to handle risk (including assessing, managing and communicating risk); and
• Equipping people with the tools they need to make informed decisions in the face of risk and uncertainty.

Looking back, the past five years with the Project on Emerging Nanotechnologies has been tremendously exciting.  Although I’m hardly unbiased, I do believe that as a team we made a difference in supporting the responsible development of nanotechnologies in the US and beyond, and kept discussions surrounding the technology grounded in science.  It will be sad to leave the team, Washington DC and national politics behind as I move across to Michigan.  But at least I’m assured that academic politics are every bit as entertaining as anything you can find on Capitol Hill

Over the next few months, updates to 2020 Science may be intermittent as I find my feet, and work out how best to integrate the blog with my new position – so please bear with me.  The intent though is to continue to reflect on science and technology in the 21st century – albeit perhaps with slightly more of a risk science bent!

In the meantime, don’t forget that you can follow the 2020 Science back-story on FaceBook and Twitter.

Oh, and before I go – someone mentioned something about football and Wolverines in relation to the University of Michigan.  No idea what that was about – guess I’ll find out soon enough though…

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.

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…

Good brainstorms are oft anticipated and rarely encountered.  So I tend to get a little excited when I find myself in one that stimulates rather than stultifies.

Today at the World Economic Forum Summit on the Global Agenda had more than it’s fair share of frustrations – including what I can only describe as a masterful demonstration in the art of assisted group-think entropy (sense in, nonsense out). But rather than moan about the negatives, I want to emphasize one of the highlights of the meeting – the Global Agenda Council Fair.

The Global Agenda Council Fair is the part of the Summit where attendees are free to roam amongst the 76 councils, talking about common interests and sparking new ideas off other delegates.  For me it’s like being a kid in a candy store – a chance to dip into seventy-six groups of people ready and willing to discuss everything from the Climate Change to the Future of Entertainment.  Sadly, with only an hour or so available and an Emerging Technologies agenda to follow, I had to restrict myself to two Councils today.  But it was still a lot of fun – and very worthwhile.

So let me give you a flavor of how things worked.

The first group I visited was the Catastrophic Risks Council.  When I arrived, there was a discussion in full flow about the need to get a handle on distinguishing more likely/higher impact global catastrophic risks from those less likely to happen or cause serious harm.  A more rational approach to risk identification and action – it was being argued – would help channel resources to where they could be used most effectively, while reducing anxiety from unwarranted speculation.  The solution – a World Risk Organization.

I had come to the group in part to talk about a proposal from my own Council on a new global center to inform policies on developing safe, sustainable and successful emerging technologies, and was immediately struck by how well the two ideas meshed together.  Emerging technologies have the potential to create serious problems if not developed appropriately.  Yet they also provide possible solutions to dealing with problems from other sources.  By taking an informed approach to weighing potential risks and benefits and taking action, I could see how the two ideas could be highly complimentary.

At this point, a delegate from the International Legal System Council entered the booth.  And the immediate reaction to the idea of a World Risk Organization?  “How about the risk-equivalent of the Intergovernmental Panel on Climate Change?”

It transpired that the International Legal System Council had been working on the idea of an Intergovernmental Panel on Global Risks.

Who would have thought there would be such synergy between catastrophic risks, emerging technologies and international legal systems!

The second group I visited was the Food Security Council.  Here the discussion was a little more diffuse, but stimulating nevertheless.  The idea of using mobile phones and cellular networks to monitor and treat crops came up as an innovative intersection between emerging technologies and ensuring good food production.  It’s not a new idea, but it is a great example of how new technologies can have unexpected benefits – if accompanied by some creative lateral thinking.

More interesting was a discussion about identifying counterfeit pesticides and fertilizers.  A delegate from the Illicit Trade Council had raised the issue of how important it is to track the origin of food products, preventing illicit – and potentially harmful – products from entering the food chain.  This led to an observation that counterfeit fertilizers and pesticides are a serious problem in some developing economies.  Not only do they undermine legitimate trade, but they often jeopardize the health and safety of crops – with serious consequences to communities that rely on them.  Apparently though – and this was news to me – the origins of fertilizers and pesticides in developing economies are often hard to identify.

There was a clear link here with the potential use of emerging technologies for enabling cost-effective and robust tagging of legitimate products.  Using advances in complex chemicals, engineered nanomaterials or bioengineering, it should be possible to develop new ways to ensure the quality of agricultural products – supporting higher quality and higher volume crop yields, and improving the health and lives of people dependent on them.

In the space of an hour I had learned some new stuff, added value to other people’s concepts, and started formulating some new ideas of my own.  And this was happening all around me – 700 people being exposed to dangerously high levels of mental stimulation!

For me, this was a highlight of today’s sessions.  Okay so the two-hour meeting on reducing ten sharp ideas to eight woolly ones was a little tedious, and working out what we were supposed to be doing was challenging at times.  But the sheer enjoyment and serendipity of the Council Fair more than made up for these.

The challenge now is seeing whether any of those sparks can be coaxed into a fully fledged fire!

A new paper published on-line today in Nature Nanotechnology hints that some nanoparticles could cause damage to cells on the other side of normally tight barriers – such as the blood brain barrier or the placenta – without actually crossing the barriers.  It’s a study that could raise concerns over the safe  medical use of nanoparticles, at a time when the first human trials of “smart nanoparticle” therapeutics are being discussed.

Using an artificial system designed to investigate cellular barriers, Gevdeep Bhaba and co-authors show that high concentrations of Cobalt-Chromium alloy nanoparticles on one side of a tightly meshed layer of cells can cause measurable DNA damage to cells on the other side.  And they seem to do this without actually crossing the cellular barrier.

I’m not sure how much attention this paper will get, but given its apparent relevance to harm occurring across the placental barrier, there could be some pickup beyond the usual scientific outlets.  And interestingly, it is being published at the same time as the first human trials for a “smart nanoparticle” based cancer therapy are being reported – that’s a juxtaposition that could drive a substantial amount of interest in the research.

As I was asked to comment on it prior to its release, I thought it worth jotting some notes down here on the work, just in case anyone’s interested (I’ll be in the thick of a workshop on emerging technologies and emerging economies when the paper is published on-line, so this post is being written some time ahead of it going live).

In brief, the paper (Nanoparticles can cause DNA damage across a cellular barrier, by Gevdeep Bhaba et al., Nature Nanotechnology. DOI: 10.1038/NNANO.2009.313) describes a set of experiments carried out using an artificially grown layer of cells on a porous support.  The cells (BeWo cells for the interested, derived from a human trophoblast choriocarcinoma cell line) were grown as a multi-layered barrier, to simulate tight barriers in the body like the placental barrier.  On one side of this layer of cells were placed human fibroblast cells.  On the other side, Cobalt-Chromium alloy particles (CoCr particles) were placed.  Following introduction of the particles, the fibroblasts were checked for DNA damage using an alkaline comet assay.

Schematic of the system used by Bhabra and colleagues to investigate the potential for CoCr particles to cause DNA damage across tight cellular barriers (Nature Nanotechnology, DOI: 10.1038/NNANO.2009.313)

As you would expect in a good study, DNA damage was measured under a number of conditions, to identify what was going on.  Nanometer-scale and larger CoCr particles were used to see whether size was important.  Cobalt and Chromium ions were also used, to see whether the presence of dissolved metals was significant.  Particles were also introduced directly to the fibroblasts, to see what happened in the absence of the cellular barrier.  In addition, the concentration of Cobalt and Chromium was measured below the cellular barrier to see how much stuff (if any) got through.  And the barrier cells were treated with agents designed to block different transmission routes for certain substances, to get a handle on whether DNA damage was being caused by stuff penetrating through the barrier, or being generated (and subsequently released) from within the barrier.

The upshot of all this was that the researchers found evidence that placing Cobalt or Chromium one one side of the barrier caused measurable DNA damage in the fibroblasts on the other side, and that the damage seemed to be associated with chemicals generated within the cellular barrier by the metals.  In other words, the combination of CoCr particles and cellular barrier seemed to lead to DNA damage the other side of the barrier, even though the particles didn’t cross it!

The authors of the paper conclude:

We suggest that an evaluation of nanoparticle safety should not rely on whether they fail to gain access to privileged sites.  Instead there should also be an evaluation of their genotoxic potential for both direct and indirect effects to avoid any potential risks to targets on the distal [far] side of cellular barriers.

However, while this is an interesting paper, it wold be dangerous to speculate too far on what its relevance to nanoparticle safety.  When asked to comment briefly on the paper by the Science Media Center in the UK, this is what I wrote:

This is a study that raises an intriguing question – can foreign materials in the body cause harm across barriers like the placenta and the blood-brain barrier without actually crossing the barriers?  Evidence is presented that suggests there is some possibility of this occurring.  But the results should be treated with a high degree of caution until more is known.  In particular:

The effects seen are do not seem to be confined to nanoparticles alone.  There is some evidence that even large particles containing Cobalt and Chromium – the two specific materials studied here – can exert their influence across barriers in the body.

No evidence is presented to suggest that this is a way in which all nanoparticles can cause harm, as opposed to the specific types of nanoparticles tested.

From these results, it is not possible to say whether the observed effects could occur under real-life conditions, or whether harm could be caused at realistic exposure levels.  The concentrations of material used were very high – the equivalent of the placenta in a 9 months pregnant woman being exposed to approximately 4 – 40 grams of material. Whether such high exposures to materials like the ones used will ever occur is questionable.

While the study opens up new avenues of research, and should be of particular interest to scientists developing new nanoparticle-based drugs and medical devices, it is too early to say whether materials in the body – including nanomaterials – are likely to cause damage across normally tight barriers like the placenta.

In other words, a fascinating piece of science that raises the possibility of a novel way in which materials could cause harm, but which sheds little light on the likelihood of this being a significant concern from real products in real people.

The bottom line here is that, while this is a scientifically interesting study, it is far removed from implying that specific types of nanoparticles in the body could actually cause significant harm in this way.  Certainly, it suggests more research is needed in this area – especially as an increasing number of drugs and medical devices are developed that rely on nanoparticles, and as these products enter the human trials phase.  But at the moment, the data do not support nanoparticle-related DNA damage across the placenta (or any other tight biological barrier) as being a probable cause of serious harm.

]]> http://2020science.org/2009/11/05/could-nanoparticles-inflict-harm-across-tight-cellular-barriers/feed/ 9 http://2020science.org/2009/10/23/risk-innovation-you-what-desparately-seeking-advice/ http://2020science.org/2009/10/23/risk-innovation-you-what-desparately-seeking-advice/#comments Fri, 23 Oct 2009 14:07:39 +0000 Andrew Maynard http://2020science.org/?p=2348

Here’s something I’ve been chewing over for the past few weeks:  How do you capture succinctly the idea of developing innovative new approaches to identifying, assessing, managing and otherwise dealing with risks to human health?

What I’ve ended up with is “Risk Innovation” – but I’m not convinced it works.

So I thought I would see if anyone else had any other bright ideas!

This is the challenge in a nut shell:

When dealing with the possibility of substances harming people, there are well-established science-based approaches to identifying and quantifying the risks, backed up by a standard set of approaches to dealing with them (with regulation typically rising to the top of the pile).  But these aren’t always effective – and as technologies become more complex, development life cycles become faster and societal hierarchies shift, there’s going to be an increasing need to find new ways to deal with possible health impacts arising from substances.

In fact, the life cycle of new technologies is becoming so short that it won’t be long before they are superseded long before conventional approaches to assessing and managing risks have kicked in.

In other words, technology innovation has to be accompanied by innovations in how we handle risks, if things are going to get better rather than worse for us in the future.

This is a young area of research that is developing rapidly.  It’s stimulating, exciting and, above all, crucial to the success of emerging technologies (as well as dealing with new problems emerging from previous technologies).

But it doesn’t have a convenient “handle.”

“Innovation in risk identification, assessment, management and governance” gets to the nub of the idea.  But it is also on the soporific side of engaging.  Not to beat about the bush, it’s just not sexy!  The same goes for various other permutations that try to capture accurately the idea of developing new approaches to handling risk.

So what I’ve ended up with is “Risk Innovation.”

My problem though is that, while the phrase is catchy, it’s wide open to interpretation.  It could mean anything from innovative approaches to dealing with risk, to innovative ways of increasing risk – not something most self-respecting health professionals would want to be associated with!!

But what’s the alternative?  Or am I being over-sensitive here?

Any thoughts here (please use the comments area below) would be more than welcome.

Thanks!