Tag Archives: Andrew Maynard

Mind the Science Gap and mentoring

There’s a bunch of master’s of public health students at the University of Michigan who want to communicate about complex science to the public and you’re invited. Mind the Science Gap blog is a project of Dr. Andrew Maynard’s. The project is being presented as part of a course. Here’s a description of the course for the students (from the Syllabus webpage),

This course is designed to teach participants how to connect effectively with a non-expert audience when conveying complex science-based information that is relevant to public health, using the medium of a public science blog (http://mtsg.org).

In today’s data-rich and hyper-connected world, the gap between access to information and informed decision-making is widening.  It is a gap that threatens to undermine actions on public health as managers, policy makers, consumers and others struggle to fish relevant information from an ever-growing sea of noise.  And it is a gap that is flourishing in a world where anyone with a smart phone and an Internet connection can become an instant “expert”.

To bridge this gap, the next generation of public health professionals will need to be adept at working with new communication platforms, and skilled at translating “information” into “intelligence” for a broad audience. These skills will become increasingly relevant to communicating effectively with managers, clients and customers.  But more broadly, they will be critical to supporting evidence-informed decisions as social influences continue to guide public health activities within society.

Here’s a bit more about the blog itself and what the students will be doing (from the About page),

Mind the Science Gap is a science blog with a difference.  For ten weeks between January and April 2012, Masters of Public Health students from the University of Michigan will each be posting weekly articles as they learn how to translate complex science into something a broad audience can understand and appreciate.

Each week, ten students will take a recent scientific publication or emerging area of scientific interest, and write a post on it that is aimed at a non expert and non technical audience.  As the ten weeks progress, they will be encouraged to develop their own area of focus and their own style.

And they will be evaluated in the most brutal way possible – by the audience they are writing for!  As this is a public initiative, comments and critiques on each post will be encouraged, and author responses expected.

This is not a course on science blogging.  Rather, it is about teaching public health graduate students how to convey complex information effectively to a non-expert audience, using the medium of a science blog.

The blogging starts Jan. 16, 2012 and you are invited to participate.  You can be a casual commenter or Andrew has a list of almost 40 mentors (people who’ve committed to commenting on the content at least once per week) and he’s asking for more. BTW, I (Maryse de la Giroday) am on the list as is Robyn Sussel, health and academic communicator and principal for Signals, a Vancouver-based communications and graphic design company. If you’re interested in signing up as a mentor, you can contact Andrew through this email address: [email protected]

You can also sign up for RSS feeds.

Dr. Andrew Maynard discusses the Health Canada nanomaterial definition

I have often referred to and linked to Andrew Maynard’s writing on nanotechnology issues and am pleased to note he has kindly answered some questions about the Health Canada Working Definition of Nanomaterial. Before launching into his responses, here’s a little more about him.

Dr. Andrew Maynard was originally trained as a physicist and graduated with a PhD from Cambridge, UK  in 1993. He worked for a number of years for the UK Health and Safety Executive moving to the US to work with the National Institute of Occupational Health and Safety where he helped set up a nanotechnology safety programme post 2000 when the NNI was established. By 2005, he was employed at the Project on Emerging Nanotechnologies as their Chief Science Advisor. As of April 2010, he assumed responsibility as director of the Risk Science Center at the University of Michigan School of Public Health. He consults internationally on nanotechnology safety issues. He was a member of the expert panel consulted for the nanotechnology report, Small is Different; A Science Perspective on the Regulatory Challenges of Nanotechnology, published by the Council of Canadian Academies in 2008.

Since the 2008 report for the Council of Canadian Academies, Andrew has adopted a different approach to regulating nanotechnology, a change I first noted in an April 15, 2011 posting on the University of Michigan Risk Science Center blog. Excerpted from that posting,

Engineered nanomaterials present regulators with a conundrum – there is a gut feeling that these materials present a new regulatory challenge, yet the nature and resolution of this challenge remains elusive.  But as the debate over the regulation of nanomaterials continues, there are worrying signs that discussions are being driven less by the science of how these materials might cause harm, and more by the politics of confusion and uncertainty.

The genesis of the current dilemma is entirely understandable. Engineered nanomaterials are typically the product of nanotechnology – a technology that has been lauded as leading to designed materials with unique physical and chemical properties.   Intuitively it makes sense that these unique properties could lead to unique risks.  And indeed a rapidly growing body of research is indicating that many nanoscale materials behave differently to their non-nanoscale counterparts in biological environments. Logically, it seems to follow that engineered nanomaterials potentially present risks that depend on their scale, and should be regulated appropriately.

Yet the more we learn about how materials interact with biology, the less clear it becomes where the boundaries of this class of materials called “nanomaterials” lie, or even whether this is a legitimate class of material at all from a regulatory perspective.

I waffle somewhat largely due to my respect for Andrew and his work and due to my belief that one needs to entertain new approaches for the emerging technologies, even when they make your brain hurt. (Before proceeding with Andrew’s comments and for anyone who’s interested in my take here is, My thoughts on the Health Canada nanomaterial definition.)

In any event, here are Andrew’s responses to my questions,

  • I have warm feelings towards this definition, especially the elaboration where I think they avoided the problem of including naturally occuring nanoparticles (as per your comment about micelles in milk); and they specify a size range without being doctrinaire about it. How do you feel about it, given that you’re not in favour of definitions?

The problem is that, while the Health Canada is a valiant attempt to craft a definition based on the current state of science, it is still based on a premise – that size within a well defined range is a robust indicator of novel risk – that is questionable.  Granted, they try to compensate for the limitations of this premise, but the result still smacks of trying to shoehorn the science into an assumption of what is important.

  • Do you see any pitfalls?

A large part of the problem here is an attempt to oversimplify a complex problem, without having a clear understanding of what the problem is in the first place.  Much of my current thinking – including questioning current approaches to developing definitions – revolves round trying to work out what the problem is before developing the solution.  But this makes commenting on the adequacy or inadequacy of definitions tricky, to say the least.

  • Is there anything you’d like to add?

My sincere apologies, I’ve just got to 5:00 PM on Sunday [Oct. 23, 2011] after working flat out all weekend, and am not sure I have the wherewithal to tackle this before collapsing in a heap.

I am hugely thankful that Dr. Maynard extended himself to answer my questions about the Health Canada definition of nanomaterial. To Andrew: a virtual bouquet of thanks made up of the most stunning flowers and scents you can imagine.

More on US National Nanotechnology Initiative (NNI) and EHS research strategy

In my Oct, 18, 2011 posting I noted that the US National Nanotechnology Initiative (NNI) would be holding a webinar on Oct. 20, 2011 to announce an environmental, health, and safety (EHS) research strategy for federal agencies participating in the NNI. I also noted that I was unable to register for the event. Thankfully all is not lost. There are a couple of news items on Nanowerk which give some information about the research strategy. The first news item, U.S. government releases environmental, health, and safety research strategy for nanotechnology, from the NNI offers this,

The strategy identifies six core categories of research that together can contribute to the responsible development of nanotechnology: (1) Nanomaterial Measurement Infrastructure, (2) Human Exposure Assessment, (3) Human Health, (4) Environment, (5) Risk Assessment and Risk Management, and (6) Informatics and Modeling. The strategy also aims to address the various ethical, legal, and societal implications of this emerging technology. Notable elements of the 2011 NNI EHS Research Strategy include:

  • The critical role of informatics and predictive modeling in organizing the expanding nanotechnology EHS knowledge base;
  • Targeting and accelerating research through the prioritization of nanomaterials for research; the establishment of standardized measurements, terminology, and nomenclature; and the stratification of knowledge for different applications of risk assessment; and
  • Identification of best practices for the coordination and implementation of NNI interagency collaborations and industrial and international partnerships. “The EHS Research Strategy provides guidance to all the Federal agencies that have been producing gold-standard scientific data for risk assessment and management, regulatory decision making, product use, research planning, and public outreach,” said Dr. Sally Tinkle, NNI EHS Coordinator and Deputy Director of the National Nanotechnology Coordination Office (NNCO), which coordinates activities of the 25 agencies that participate in the NNI. “This continues a trend in this Administration of increasing support for nanotechnology-related EHS research, as exemplified by new funding in 2011 from the Food and Drug Administration and the Consumer Product Safety Commission and increased funding from both the Environmental Protection Agency and the National Institute of Occupational Safety and Health within the Centers for Disease Control and Prevention.”

The other news item, Responsible development of nanotechnology: Maximizing results while minimizing risk, from Sally Tinkle, Deputy Director of the National Nanotechnology Coordination Office and Tof Carim, Assistant Director for Nanotechnology at OSTP (White House Office of Science and Technology Policy) adds this,

Core research areas addressed in the 2011 strategy include: nanomaterial measurement, human exposure assessment, human health, environment, risk assessment and management, and the new core area of predictive modeling and informatics. Also emphasized in this strategy is a more robust risk assessment component that incorporates product life cycle analysis and ethical, legal, and societal implications of nanotechnology. Most importantly, the strategy introduces principles for targeting and accelerating nanotechnology EHS research so that risk assessment and risk management decisions are based on sound science.

Progress in EHS research is occurring on many fronts as the NNI EHS research agencies have joined together to plan and fund research programs in core areas. For example, the Food and Drug Administration and National Institutes of Health have researched the safety of nanomaterials used in skin products like sunscreen; the Environmental Protection Agency and Consumer Product Safety Commission are monitoring the health and environmental impacts of products containing silver nanoparticles, and National Institute of Occupational Safety and Health has recommended safe handling guidelines for workers in industries and laboratories.

Erwin Gianchandani of the Computing Community Consortium blog focuses, not unnaturally, on the data aspect of the research strategy in his Oct. 20, 2011 posting titled, New Nanotechnology Strategy Touts Big Data, Modeling,

From the EHS Research Strategy:

Expanding informatics capabilities will aid development, analysis, organization, archiving, sharing, and use of data that is acquired in nanoEHS research projects… Effective management of reliable, high-quality data will also help support advanced modeling and simulation capabilities in support of future nanoEHS R&D and nanotechnology-related risk management.

Research needs highlighted span “Big Data”…

Data acquisition: Improvements in data reliability and reproducibility can be effected quickly by leveraging the widespread use of wireless and video-enabled devices by the public and by standards development organizations to capture protocol detail through videos…

Data analysis: The need for sensitivity analysis in conjunction with error and uncertainty analysis is urgent for hazard and exposure estimation and the rational design of nanomaterials… Collaborative efforts in nanomaterial design [will include] curation of datasets with known uncertainties and errors, the use of sensitivity analysis to predict changes in nanomaterial properties, and the development of computational models to augment and elucidate experimental data.

Data sharing: Improved data sharing is a crucial need to accelerate progress in nanoscience by removing the barriers presented by the current “siloed” data environment. Because data must be curated by those who have the most intimate knowledge of how it was obtained and analyzed and how it will be used, a central repository to facilitate sharing is not an optimal solution. However, federating database systems through common data elements would permit rapid semantic search and transparent sharing over all associated databases, while leaving control and curation of the data in the hands of the experts. The use of nanomaterial ontologies to define those data elements together with their computer-readable logical relationships can provide a semantic search capability.

…and predictive modeling:

Predictive models and simulations: The turnaround times for the development and validation of predictive models is measured in years. Pilot websites, applications, and tools should be added to the NCN [Network for Computational Nanotechnology] to speed collaborative code development among relevant modeling and simulation disciplines, including the risk modeling community. The infrastructure should provide for collaborative code development by public and private scientists, code validation exercises, feedback through interested user communities, and the transfer of validated versions to centers such as NanoHUB… Collaborative efforts could supplement nanomaterial characterization measurements to provide more complete sensitivity information and structure-property relationships.

Gianchandani’s post provides an unusual insight into the importance of data where research is considered. I do recommend more of his posting.

Dr. Andrew Maynard on his 2020 Science blog has posted as of Oct. 20, 2011 with a comparison of the original draft to the final report,

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

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

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

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

Andrew examines the document further,

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

Andrew’s post is well worth reading especially if you’ve ever made a submission to a public consultation held by your government.

The research strategy and other associated documents are now available for access and the webinar will be available for viewing at a later date. Go here.

Aside, I was a little surprised that I was unable to register to view the webinar live (I wonder if I’ll encounter the same difficulties later). It’s the first time I’ve had a problem viewing any such event hosted by a US government agency.

The French and others weigh in on the European nanomaterials definition (included here)

The responses to the announcement of the nanomaterials definition for Europe are coming fast and furious now. A summary from L’Association de Veille et d’Information Civique sur les Enjeux des Nanosciences et des Nanotechnologies (L’Avicenn) is available in an Oct. 20, 2011 news item on Nanowerk (French language version is available here),

Avicenn offers a first insight into the politics hidden behind this supposedly neutral and “scientific” definition, the next obstacles and important meetings, and then concludes on the suspense surrounding the definition that France will finally adopt for the annual mandatory declaration of nanomaterials it is implementing.

In a self-applauding press release, the European Commission announced yesterday that it finally published “a clear definition (of nanomaterials) to ensure that the appropriate chemical safety rules apply”. Nanomaterial is defined as:

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

Here’s a list of the responding organizations (from the Oct. 20, 2011 news item on Nanowerk),

After the release of this new definition, the most active “stakeholders” have already formally responded: among them, on the side of CSOs, the European Environmental Bureau (BEE) – the federation of 140+ environmental organisations in 31 countries, Friends of the Earth Australia (FoE Australia), the Center for International Environmental Law (CIEL), the European Consumers’ Organisation (BEUC) or the European consumer voice in standardisation (ANEC); on the industrial side, the European Chemical Industry Council (CEFIC).

I posted European nanomaterials definition not good enough about the response from the European Environmental Bureau yesterday (Oct. 19, 2011). So this may seem mildly repetitive (from English language tranaslation on the Avicenn website),

  • The new 100 nm upper limit

Friends of the Earth Australia, ANEC and BEUC denounce the adoption of the upper limit of 100 nm that they consider too restrictive: these CSOs would have preferred a higher threshold limit, that would have encompassed more materials. They refer to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)’s highlight of the lack of scientific basis for this 100nm limit, and to results of toxicology studies on toxicity of submicron particles over 100 nm.
As illustrated by Foe Australia, “if this definition were applied to regulation, it would mean that where 45% of particles are 95nm in size and 55% particles are 105nm in size, substances would not be regulated as nano”at the expense of consumers and workers exposed to these substances and over whom will therefore keep hanging the threat of a risk that is assumed but not evaluated.
In response to EC consultation on its draft definition in 2010, many CSOs [civil society organizations] had argued for a threshold of 300 nm.
FoE Australia alerts to the fact that “some European cosmetics companies and North American bioactive manufacturers are reformulating their products to exploit the novel optical, chemical and biological properties of larger nanomaterials (ie >100nm) while escaping the labelling and safety assessment requirements that were anticipated for materials 1-100nm in size”.

  • 50% threshold

Some organizations – including CIEL and ANEC – applaud the choice of particle number (i.e. the number of particles) rather than mass as a measuring unit for size distribution of a nanomaterial product ; in contrast, CEFIC (which had strongly advocated using weight concentration rather than particle number distribution to determine the cut-off criterion for nanomaterials) is concerned that the adoption of this definition will add unnecessary burden for companies, leading to added costs and less efficient use of resources. The Commission followed by the recommendations of SCENIHR, which had been particularly supported by ANEC in 2010.
The Commission, however, largely raised the proportion of nano-sized materials required to qualify as nanomaterial compared to what was expected: 50% or more of the particles in the number size distribution is 50 times higher than the one that was proposed by DG Environment and supported by civil society (1%) and 333 times greater than that recommended by SCENIHR (0.15%) and supported by DG Sanco.
CSOs have expressed their surprise, incomprehension and hostility to such a high threshold. For example CIEL pinpoints that even the German industry had not been so demanding: it had campaigned for a rate of 10% “only”. However, the Commission provided that “in specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %”. While CIEL or ClientEarth welcome this opportunity, FoE Australia deplores that it puts a huge burden of proof on to the CSOs to demonstrate not only that certain nanomaterials can cause harm but that certain they do so as a specific proportion of particles in a sample. Showing that some nanomaterials can cause damage in itself is already very difficult by the uncertainties, the gaps in the safety science, the variability of nanomaterials and the lack of information about real life exposure. But making the same demonstration by identifying the fraction of nanoparticles in a sample that cause such harm is even more difficult, actually well beyond current scientific knowledge.

  • The inclusion of aggregate and agglomerate

CIEL appreciates the inclusion of aggregate and agglomerate within the definition. CEFIC believes that this measure will make any European legislation on nanomaterials too restrictive.

The apparent technical nature of these debates and, ultimately, the arbitrary selection of thresholds illustrate the strong political dimension at work behind the decisions made by the EC : granted, the European authorities have had to make a decision based on “sound science” – backed by consultation of scientific experts – but in the end, they mainly had to come up with a trade-off between conflicting interests of stakeholders.

Here’s how they hope the French government will respond to all of this (from the English translation on the Avicenn website),

As far as France is concerned, it is not clear at present whether the decree on the annual declaration of “substances with nanoparticle status” will use the new definition of the European Commission. In its decree, the French government might try to maintain a larger definition than the definition adopted by the Commission. CSOs are turning with hope towards French choice which will be determinant for the future: if the adopted definition is larger than that of the Commission and therefore more in line with the precautionary principle, it could serve as an example and be followed in other countries.

For anyone who may not be familiar with some recent French nanotechnology history, in the Spring of 2010 there were major nanotechnology protests in France during a series of public debates.  You can read more about them in my Jan. 26, 2011 posting, Feb. 26, 2010 posting, and followup March 10 , 2010 posting, which includes details about a French-language podcast with two Québec academics discussing the French protests.

This does clear up one question I had about European Commission (EC) jurisdictions and national jurisdictions. It seems that countries can choose to create their own definitions although I imagine they cannot be at cross-purposes with the EC definition.

On an almost final note, here’s Dexter Johnson (Nanoclast blog for the Institute of Electrical and Electronics Engineers [IEEE]) in his Oct. 19, 2011 posting,

The definition itself…well, I don’t see how it helps to narrow anything, which I understand to be one of the main purposes of definitions. It would seem that the nanoparticles that are given off when your car’s tires roll along the pavement are now up for regulatory policy (“Nanomaterial” means a natural, incidental or manufactured material containing particles…”). And due to the lack of distinction between “hard” and “soft” nanoparticles in the definition, Andrew Maynard points out that “someone needs to check the micelle size distribution in homogenized milk.”

So what is the fallout from this definition? It would seem to be somewhat less than had been anticipated earlier in the year when worries surrounded getting the definition just right because it would immediately dictate policy.

So basically they have created a class of materials that at the moment are not known to be intrinsically hazardous, but if someday they are they now have a separate class for them. While some may see as this as making some sense, it eludes me.

As for me, I think much depends on future implementations. After all, you can have the best system possible but if it’s being run by fools, you have a big problem. That said, I take Dexter’s point about establishing a class of materials ‘just in case there could be a problem’. I really must take another look at the Health Canada nanomaterials definition.

Note: I removed footnotes from the Avicenn material; these can easily be found by viewing either the Oct. 20, 2011 news item on Nanowerk or the material on the Avicenn site.

ETA Oct. 20, 2011 1500 hours: I forgot to include a link to the ANEC response in this Oct. 20, 2011 news item on Nanowerk.

European nanomaterials definition not good enough

The European Environmental Bureau (EEB) has released a statement about the definition of nanomaterials that has been adopted (mentioned in my Oct. 18, 2011 posting) from the Oct. 19, 2011 news item on Nanowerk,

The European Environmental Bureau (EEB) is deeply disappointed by the European Commission’s decision released yesterday to use a narrow definition for the term “nanomaterial”, indicating that industry lobbying has won over the Commission’s own scientific advisors. EEB did however welcome the fact that a recommendation was adopted and hopes this will clear the way for the EU to actually start regulating on this.

The EEB echoed one of Dr. Andrew Maynard’s concerns (here’s Andrew’s concern from my Oct. 18, 2011 posting),

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

Here’s what the EEB had to say (from the Oct. 19, 2011 news item),

It is completely unclear from the Commission’s publication how the threshold was multiplied by 50 from the original 1% when scientists had in fact called for a 0.15% threshold.

One of Andrew’s commenters provides some insight (Note: It is quite technical) from the comments to Andrew’s Oct. 18, 2011 posting,

The 50% benchmark appears not to be arbitrary: SWNTs are p-FETs when exposed to oxygen and n-FETs otherwise. It has been proven possible to protect half of an SWNT from oxygen exposure, while exposing the other half to oxygen, so this control measure seems to one of flammability risk mitigation. (excerpted from LaVerne Poussaint,  October 18, 2011 at 5:34 pm)

I’ve included Poussaint’s comment as it provides what I consider a fascinating insight into just how complex this conversation can get.

Nanomaterials definition for Europe

After all the ‘sturm und drang’ in the last few months (my Sept. 8, 2011 posting summarizing some of the lively discussion), a nanomaterials definition for Europe has been adopted. It is the first ‘cross-cutting’ nanomaterials definition to date according to the Oct. 18, 2011 news item on Nanowerk,

“Nanomaterials” are materials whose main constituents have a dimension of between 1 and 100 billionth of a metre, according to a Recommendation on the definition of nanomaterial (pdf) adopted by the European Commission today. The announcement marks an important step towards greater protection for citizens, clearly defining which materials need special treatment in specific legislation.

European Environment Commissioner Janez Potocnik said: “I am happy to say that the EU is the first to come forward with a cross-cutting designation of nanomaterials to be used for all regulatory purposes. We have come up with a solid definition based on scientific input and a broad consultation. Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances. It is an important step towards addressing any possible risks for the environment and human health, while ensuring that this new technology can live up to its potential.”

As I understand it , ‘cross-cutting’ doesn’t refer to national boundaries so much as it refers to agency boundaries. Take for example the recent nanomaterial definition (my initial comments in an Oct. 11, 2011 posting) adopted by Health Canada. It is applicable only to Health Canada’s jurisdictional responsibilities. Environment Canada uses a different definition.

As for the new European definition of nanomaterials, Dr. Andrew Maynard offers some interesting observations on his 2020 Science blog in an Oct. 18, 2011 posting (Note: Andrew favours an approach other than the one adopted by the European Commission and was an active participant in the lively discussion that took place),

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

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

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

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

Andrew does include the full text of the definition and more points of interest in his full posting. I’m very happy to see his comments as they give me some guidance as I get ready to review the Health Canada definition more closely.

ETA Oct. 18, 2011 1500 hours: The European Commission released the Joint Research Centre (JRC) and the European Academies Science Advisory Council (EASAC) presented the findings of a joint report entitled “Impact of engineered nanomaterials on health: considerations for benefit-risk assessment” (pdf). This was an  event designed to coincide with the adoption of a definition for nanomaterials. The Oct. 18, 2011 news item on Nanowerk notes,

This fulfils one of the recommendations of the report, which was a call for a precise definition of nanomaterials.

ETA Oct. 18, 2011 1525 hours: I particularly appreciate Andrew’s dry comment about micelle and liposome distribution in milk at the end of his first point.

ETA: NanoWiki offers a roundup of responses in an Oct. 21, 2011 posting.

US National Nanotechnology Initiative holding EHS webinar

There’s an Oct. 15, 2011 news item on Nanowerk announcing the US National Nanotechnology Initiative’s Environmental, Health, and Safety webinar on research strategies.

Federal Agencies participating in the National Nanotechnology Initiative (NNI) are hosting a webinar to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy and to the discuss the development of this document and its key focus areas. The webinar will be held October 20, 2011 from 12 noon until 12:45p.m [EDT].

The event will consist of an overview of the strategy’s development followed by comments from industrial, regulatory, and public health perspectives. Dr. John Howard, Nanotechnology Environmental and Health Implications (NEHI) Working Group Co-Chair, will serve as the moderator. Panelists include:

  • Dr. Treye Thomas, NEHI Working Group Co-Chair
  • Dr. Shaun Clancy, Evonik DeGussa Corporation
  • Dr. Janet Carter, Occupational Safety and Health Administration (OSHA)
  • Ms. Lynn Bergeson, Bergeson & Campbell

The webinar will also feature a 20-minute question-and-answer segment following the presentations. Questions may be submitted prior to the webinar to [email protected] beginning at noon (EDT) Wednesday, October 19, 2011 and will be accepted until the close of the webinar at 12:45 p.m. Thursday, October 20, 2011. [???]

I’m pretty sure that last bit is an error. I can’t imagine a webinar that lasts for 25 hours, at least not on this topic.

As registration is necessary to watch the webinar, I tried to do so and failed each time. I think the problem is that I don’t have a zip code. Usually I can fill in a Canadian postal code instead but this system rejected every attempt. If you do have a US zip code, you can register here.

In preparation for this webinar about EHS research strategies to be undertaken by US federal agencies, Dr. Andrew Maynard has summarized some of the public comments about the  key recommendations in the draft version, which was published in December 2010. Excerpted from Andrew’s Oct. 15, 2011 posting,

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.

There’s a lot more in Andrew’s posting. It saddens me even more now that I see Andrew’s posting that Health Canada did not make the submissions to its public consultation on “Policy Statement on Health Canada’s Working Definition for Nanomaterials” available for viewing (my Oct. 11, 2011 posting).

Nanomaterials, nanomedicines and nanodefinitions

I was chatting earlier this week, in the most general way possible, with someone in Ottawa about nanotechnology and regulations.  The individual noted that nanotechnology initiatives in various countries and regions are attaining traction and I think the evidence is in the increased (and heated) discussion/debate about defining nanomaterials. The latest twist in the discussion comes from Alok Jha, a science writer for The Guardian. In his Sept. 6, 2011 article, Nanotechnoglogy world: Nanomedicine offers new cures, he tackles the topic from the nanomedicine perspective.

The EU ObservatoryNano organisation, which supports European policy makers through scientific and economic analysis of nanoscience and nanotechnology developments, produced a report on the ethics of nanotechnology written by Ineke Malsch, director of Malsch TechnoValuation. She says the problem with regulating medical nanotechnology can be how to define a product’s area of application. “The distinction between a medical device and a pharmaceutical is quite fuzzy. …”

How do you regulate a drug-releasing implant, for example? Is Cuschieri’s nano-carrier a pharmaceutical or a medical device? One of [the] key issues, says Malsch, is that there is the lack of common agreement or definition, at the international level, of what a nanoparticle is and what constitutes nanomedicines. “There is continuing discussion about these definitions which will hopefully be resolved before the end of the year.”

Current regulations are more than enough for current technologies, says Malsch, but she adds that this will need to be kept under review. But over-regulating now would also be a mistake. Pre-empting (and trying to pre-regulate) technology that does not yet exist is not a good idea, she says.

This view was backed up by Professor Andrew Maynard, the director of the Risk Science Centre, who says: “With policy-makers looking for clear definitions on which to build ‘nano-regulations’, there is a growing danger of science being pushed aside.”

This (the fuzzy distinction between a pharamaceutical and a medical device) certainly adds a new twist to the debate for me.

Also, I should note that this article’s banner says: Nanotechnology world, in association with Nano Channels.Tim Harper (Cientifica and TNTlog) noticed in an earlier Guardian article on nanotechnology (from his July 7, 2011 posting),

My delight at seeing a sensible piece about “nanotechnology in everyday life” by Colin Stuart (@skyponderer) published in the Guardian Newspaper turned to puzzlement when I noticed that the article was “Paid for by NanoChannels.”

There seems to be some distinction between “paid for” and “in association with,” but I can’t confirm that at this time. Now back to the topic.

In my August 31, 2011 posting, I noted the latest salvo from Hermann Stamm, of the European Commission Joint Research Centre, Institute for Health and Consumer Protection where he reiterated that a hard and fast definition based on size is the best choice. In his Sept. 6, 2011 posting, Andrew where he expands on a concern (i. e. policymakers will formulate a definition not based on scientific data but based on political pressures and/or public relations worries) that I’ve given short shrift. From his Sept. 6, 2011 posting,

And despite policy makers repeatedly stating that any form of nanomaterial regulation should be science-based, I have the sense that they are scrambling to use science to justify a predetermined conclusion – that engineered nanomaterials should be regulated on the basis of a hard and fast definition – rather than using science to guide their actions.Instead, I would suggest that we need to put aside preconceptions of what is important and what is not here, and start by asking how new generations of sophisticated (or advanced) materials interact with biological systems; where these interactions have the potential to cause harm in ways not captured within current regulatory frameworks; and how these frameworks can be adapted or altered to ensure that an increasing number of unusual substances are developed and used as safely as possible – no matter what label or “brand” is applied to them.

He was a little more explicit about what he thinks are the reasons behind this preference for a “hard and fast definition” in his April 15, 2011 posting,

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.

 

All this got me to thinking about the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials and the public consultation which ended August 31, 2010.  According to the website, we will be learning the results of the consultation,

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.  Health Canada will take further steps to illustrate how the policy statement will be applied in specific contexts.  These steps could include guidance documents for specific products or substances, targeted workshops and postings of answers to frequently asked questions.  The Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials will be updated as comments are received, as the body of scientific evidence increases, and as international norms progress.

If you have any questions, contact [email protected].

Strangely, there’s no mention of the 29 submissions that were made (my May 27, 2011 posting)  or a listing of who made the submissions as was done for Canada’s ‘innovation consultation’ or, more formally, the Review of Federal Support to Research and Development (which started in Oct. 2010 and ended in Feb. 2011 and received some 250 submissions).

To define or not to define nanomaterials

There’s been a debate of sorts over whether or not nanomaterials should be defined prior to setting a regulatory framework. It’s a topic I covered most recently in my July 8, 2011 posting,

I have mentioned Andrew’s (Dr. Andrew Maynard [Director of University of Michigan Risk Science Center]) perspective vis à vis bypassing a definition of nanomaterials and getting on with the task of setting a regulatory framework in my June 9, 2011 and my April 15, 2011 postings. I expressed some generalized doubts about this approach in the earlier posting while noting that both Andrew and Dexter Johnson (Nanoclast blog on the IEEE [Institute of Electrical and Electronics Engineers]  Spectrumwebsite) have a point when they express concern that the definition may be based on public relations concerns rather than science.

Andrew’s  ‘comment’, Don’t define nanomaterials, had been published the day before in the journal Nature. An Aug. 30, 2011 news item on Nanowerk alerted me to the latest development. A few days ago, Hermann Stamm of the European Commission Joint Research Centre, Institute for Health and Consumer Protection had a rejoinder published, Risk factors: Nanomaterials should be defined.

So here’s how this part of the debate started in July, Andrew notes his concern that policymakers will give in to expediency and define nanomaterials primarily in relation to size, i. e., 1 to 100 nanometres. From Andrew’s July 7, 2011 Nature comment (Note: This is behind a paywall, you can read a draft version here),

It makes sense to assume that nanomaterials could come with unanticipated risks. A rapidly growing body of research indicates that some nanoscale materials behave differently from their bigger and smaller counterparts1. For instance, normally benign titanium dioxide — widely used as a whitener — becomes increasingly toxic as its particle size shrinks. Nanoscale titanium dioxide has been classified as a potential human carcinogen by the US National Institute for Occupational Safety and Health.

But it is becoming clear that many parameters other than size modulate risk, including particle shape, porosity, surface area and chemistry. Some of these parameters become more relevant at smaller scales — but not always. The transition from ‘conventional’ to ‘unconventional’ behaviour, when it does occur, depends critically on the particular material and the context.

A ‘one size fits all’ definition of nanomaterials will fail to capture what is important for addressing risk.

He then provides a series of arguments supporting his notion that a list of attributes along with values that would precipitate action is preferable to what he described as a ‘one size fits all’ approach.

Herman Stamm’s rejoinder (August 25, 2011 Nature comment [Note: this is behind a paywall]) simplifies Andrew’s arguments for a simple reiteration of his position,

Maynard’s point that such materials are heterogeneous is justified. However, they all have structures on the nanoscale, which modify their other properties. Size is therefore the most appropriate parameter on which to base a broad definition …

My concern with these things has to do with implementation and which approach is going to ensure better safety? Andrew’s approach reminds me of fuzzy logic and computers. I think they’re called ‘if then’ programming scripts: if [xxx happens] then do [yyy]; if [ssss happens] then do [ttt] and so on. Stamm’s approach is a standard one for regulation, i. e., create a hard and fast rule.

Both approaches have their strengths and weaknesses. Andrew’s proposed method allows for great flexibility and agility but as the system becomes more complex (and they always do) then there’s a strong probability of incompatible ‘scripts’ and if there isn’t an overarching principle or rule, then disputes become very difficult if not impossible to resolve.

Stamm’s method, i. e., using size as the key determinant for a rule is likely to lead to an inflexibile attitude and a lack of agility when dealing with situations that are ambiguous or don’t fit the definition. Who hasn’t experienced or heard of a bureaucrat who abides strictly by the rules as written even if they’re not appropriate for the specific situation?

As I’ve noted before I’m slowly coming round to Andrew’s suggestion although I continue to have doubts.

Mesocosms and nanoparticles at Duke University

It’s that time of year when just about everybody seems to be on holidays and finding material to post about becomes harder than usual.  Consequently, I dug through some of my backfiles to find this piece on mesocosms and Duke University from November 2010.

From the article, Ecosystem experiments to assess the environmental impact of nanoparticles, by Whitney J. Howell published November 25, 2010 on Nanowerk,

Deep inside Duke Forest, 32 alternate universes sit in quiet rows. They look identical – each with a puddle, some land, a few plants.

But wholly imperceptible to the naked eye, these plots have distinct and important differences.

The realms, known as mesocosms, house individual types of nanoparticles as part of a research effort conducted by the Center for the Environmental Implications of Nano Technology (CEINT) based at Duke University.

The mesocosms are (from the CEINT Mesocosm Construction page) “3ft x 12ft [constructed environments] where researchers can add nanoparticles [to study interactions] and effects on plants, fish, bacteria, and other elements within these contained systems.”

Mesocosm prototypes at Duke University (downloaded from Nanowerk)

According to Howell’s article (originally published in the Raleigh News & Observer), the mesocosm project at Duke should be winding up shortly,

To track where and at what levels the environment absorbs nanoparticles, CEINT began the yearlong mesocosm project in August [2011]. The findings will also reveal the effects of nanoparticle presence.

Each waist-high, 3-foot-by-12-foot box contains nanoparticles coated with a different substance, such as titanium dioxide or silver. By following the coating’s trail through the mesocosm, Wiesner said, researchers can pinpoint how the nanoparticles either positively or negatively alter their surroundings and at what levels they might become toxic.

For example, nanosilver has anti-microbial properties and could be a powerful disinfectant. But if high concentrations of the particles wipe out all surrounding bacteria and viruses – even those that may be benign or beneficial – the effects on plants and animals is unknown.

The Duke investigators are monitoring the mesocosm changes as nanosilver and other nanoparticle levels increase, hoping to identify which substances are most harmful to the environment and humans, and at what level they become worrisome.

CEINT’s external advisory board features Dr. Andrew Maynard, Director of the University of Michigan Risk Science Center (and mentioned here fairly frequently due to his longstanding expertise on nanotechnology [he was formerly the Chief Science Advisor for the Project on Emerging Nanotechnologies based in Washington, DC]).

They’ve been busy at the CEINT, here’s where you can find a list of publications by the staff, including blockbusters such as,

Shoults-Wilson, WA, Zhurbich OI, McNear DH, Tsyusko OV, Bertsch PM, Unrine JM.  2011.  Evidence for avoidance of Ag [silver] nanoparticles by earthworms (Eisenia fetida). Ecotoxicology. 20:385-96. Abstract

And

Chae, SR, Hotze EM, Xiao Y, Rose J, Wiesner MR.  2010.  Comparison of Methods for Fullerene Detection and Measurements of Reactive Oxygen Production in Cosmetic Products. Environmental Engineering Science. 27:797-804. Abstract

You can find more of Whitney Howell’s work here.