regulation « FrogHeart

Archive for the ‘regulation’ Category

ISO nanomaterials definition

Thursday, August 19th, 2010

There’s a new definition from the International Standards Organization (ISO) for nanomaterials. From the news item on Nanowerk,

ISO has therefore published a new technical report, ISO/TR 11360:2010, Nanotechnologies – Methodology for the classification and categorization of nanomaterials, offering a comprehensive, globally harmonized methodology for classifying nanomaterials.

…

ISO/TR 11360 introduces a system called the “nano-tree”, which places nanotechnology concepts into a logical context by indicating relationships among them as a branching out tree. The most basic and common elements are defined as the main trunk of the tree, and nanomaterials are then differentiated in terms of structure, chemical nature and other properties.

“The document provides users with a structured view of nanotechnology, and facilitates a common understanding of its concepts,” says Peter Hatto, Chair of the committee that developed the standard (ISO/TC 229). “It offers a systematic approach and a commonsensical hierarchy”.

The new definition is called: ISO/TR 11360:2010, Nanotechnologies – Methodology for the classification and categorization of nanomaterials. It will cost you 112 Swiss Francs or, roughly, $112.90 CAD.

I’m not sure what the big difference is between this definition and the one I posted about Oct. 24, 2008 but I suspect the difference lies in the classification level, i.e., the 2008 definition (ISO/TS 27687:2008 titled Nanotechnologies — Terminology and definitions for nano-objects — Nanoparticle, nanofibre and nanoplate) laid the groundwork for this more specific nanomaterials definition.

ETA Aug.21.10: Dexter Johnson at Nanoclast has posted about the new ISO definition and the impact this may have on commercialization of nanomaterials. Go here to read more.

Tags: commercialization, Dexter Johnson, International Standards Organisation, ISO, ISO nanomaterials definition, ISO/TR 11360:2010, ISO/TS 27687:2008, Nanoclast, nanofibre and nanoplate, Nanotechnologies -- Terminology and definitions for nano-objects -- Nanoparticle, Nanotechnologies – Methodology for the classification and categorization of nanomaterials, Peter Hatto
Posted in nanotechnology, regulation | No Comments »

Intersection of philosophy, science policy, and nanotechnology regulation

Thursday, July 29th, 2010

After coming across a mention of John Rawls in a July 11, 2010 posting by Richard Jones (Soft Machines blog) and his (Rawls’) notions about how people and groups with diverse interests can come to agreements on social norms, I wondered why I hadn’t heard of Rawls before and how his thinking might apply to nanotechnology regulatory frameworks.

Assuming I might not be alone in my ignorance of Rawls’ work, here’s a brief description from a Wikipedia essay,

John Bordley Rawls (February 21, 1921 – November 24, 2002) was an American philosopher and a leading figure in moral and political philosophy. … His magnum opus, A Theory of Justice (1971), is now regarded as “one of the primary texts in political philosophy.”[1] His work in political philosophy, dubbed Rawlsianism,[2] takes as its starting point the argument that “most reasonable principles of justice are those everyone would accept and agree to from a fair position.”[1]

(The footnote details can be found by following the essay link.) I think the idea of people being able to come to agreements when they operate from a fair position is both interesting and seems to be borne out by a recent study in the US that Steffen Foss Hansen has recently published in the Journal of Nanoparticle Research. Michael Berger at Nanowerk has written an in depth article about the study and multicriteria mapping, the technique used to measure and evaluate interviewees’ positions on nanotechnology regulatory frameworks. From the Berger article,

Multicriteria Mapping [MCM] is a computer-based decision analysis technique that provides a way of appraising a series of different potential ways forward on a complex and controversial policy problem. Like other multicriteria approaches, it involves developing a set of criteria, evaluating the performance of each option under each criterion, and weighting each criterion according to its relative importance.

Hansen interviewed 26 stakeholders, including academics, public civil servants, corporate lawyers, [public interest groups,] and representatives from worker unions, industrial companies, and trade association.

One aspect of this research that I thought particularly useful is that the interviews are structured dynamically. From the study,

Once the criteria had been defined, the interviewee was asked to evaluate the relative performance of the different policy options on a numerical scale (0–100) under each of the criteria one-by-one. Zero representing the worst relative performance and a 100 the best. In order to allow for uncertainty in the estimation MCM allows the interviewee to give a range (e.g., 20–30) and to make worst- and best-case assumptions. The lowest values assigned to an option would then reflect the option considered under worst case assumptions whereas the highest would reflect the same option considered under best-case assumptions. Throughout this scoring process the interviewee was asked to explain the value or range assigned to options and assumptions made. One interview had to be terminated at this stage of the interview as the participant realized that he/she had yet to develop a formalized opinion on the most preferred options. Others expressed some dislike with having to put a numerical estimate on something which they normally only discuss in qualitative terms. Others again found it challenging to have to look at all the options through all their criteria scoring and explaining the scoring of up to 72 combinations of policy options and criteria. Normally they would not have to explain their position in such depth. … MCM is an iterative process, so interviewees were free to return to review earlier steps of the process at any stage of the interview. (Journal of Nanoparticle Research, vol. 12, p. 1963)

Bravo to the interviewees for going through a demanding process and putting their opinions to the test. Also, I understood from reading the study that MCM captures both quantitative (as the preceding excerpt shows) and qualitative data, an approach I’ve always favoured.

Berger’s article goes on to discuss the results from the study,

“Adopting an incremental approach and implementing a new regulatory framework have been evaluated as the best options whereas a complete ban and no additional regulation of nanotechnology were the least favorable” Hansen explains the key findings to Nanowerk.

Participants described their idea of an ‘incremental approach’ as “…launching an incremental process using existing legislative structures—e.g., dangerous substances legislation, classification and labeling, cosmetic legislation, etc.—to the maximum, revisiting them, and, when appropriate only, amending them…” and a ‘new regulatory framework’ as “…launching a comprehensive, in-depth regulatory process specific to nanotechnologies that aims at developing an entirely new legislative framework that tries to take all the widely different nanomaterials and applications into consideration.”

Hansen notes that comparing the ranking of the various options by the stakeholder groups reveals that an incremental approach was ranked highest by a majority of the various stakeholder groups e.g. civil servants, public interest groups, industrial company representatives and corporate lawyers.

Who would have thought that the most extreme ends of opinion as represented by public interest groups that usually favour the precautionary principle and industrial company representatives who argue in favour of little or voluntary regulation could agree on an incremental approach? I suppose it gets back to Rawls and his notion of coming to an agreement from “a fair position.”

More work needs to be done, it’s a single study, only 26 interviews took place, the MCM is a snapshot of a moment in time and may no longer reflect the interviewee’s personal opinions, and the regulatory situation in the US has changed since these interviews took place. Still, with all these caveats, and I’m sure there are others, the study offers encouraging news about diverse groups being able to come to an agreement on the subject of nanotechnology regulatory frameworks.

Tags: John Rawls, MCM, Michael Berger, multicriteria mapping, nanotechnology regulatory frameworks, Nanowerk, political philosophy, Steffen Foss Hansen
Posted in nanotechnology, regulation | No Comments »

UK House of Lords debate on nanotechnologies and food and a brief overview of various nanotechnology and nanomaterial definitiions

Wednesday, July 14th, 2010

The Head of Press in the UK’s House of Lords sent me (it wasn’t addressed personally so I imagine I’m on a mailing list) an embargoed communication yesterday. (I was thrilled.) It was also an invitation to watch a live stream of the debate in the House of Lords about the Nanotechnologies and Food: Science and Technology Committee Report. (I’ve commented on both the report [January 7, 2010 posting] and the government’s response [March 29, 2010 posting].)

Sadly I wasn’t able to watch the debate in real-time (browser issues and my technical illiteracy) but, happily, a transcript is available here.

I have a few tidbits from the transcript, the first from Lord Krebs who’s presenting the report,

Nanotechnology is the study of the very small. It involves manipulating matter on the scale of atoms or molecules. If you are like me, you may find it difficult to get your mind around just how small “small” means. Let me give you an idea. It is sometimes claimed that medieval scholars such as Duns Scotus and Thomas Aquinas debated the question of how many angels can fit on the head of a pin or even the point of a needle. The authenticity of this claim is disputed, although in 1667 Richard Baxter, in his tract The Reasons of the Christian Religion, definitely refers to such a debate. If we move from angels to nanoparticles, how many could you fit on the head of a pin? The answer is 300 million nanoparticles, each 100 nanometres in diameter. Alternatively, your Order Paper is roughly 100,000 nanometres thick. A further day-to-day illustration to make the point for noble Lords present is that their beards will have grown by roughly 200 nanometres since I started speaking. That is not a personal statement but a general phenomenon. [emphases mine]

It’s hard to imagine a contemporary Canadian politician making references to contested medieval theological debates as a segue to a discussion about nanoparticles and the nanoscale.

Lord Krebs goes on make this statement,

Our proposal, based on the evidence we heard, was that, for regulatory purposes, the definition of nanoparticles should focus not on size alone-after all, size is not everything-but also on functionality; that is, how the nanoscaled material interacts with the human body. The key question for risk assessment and therefore for regulation is whether nanoscaling a material changes its properties in such a way as to have a potentially toxic effect on the body. We urge the Government in our report to take forward this matter of definition in Europe. [emphasis mine]

The comment about the definition sprang out as this issue seems to be at the forefront of many recent discussions on nanotechnology. Fern Wickson and her colleagues highlight the importance of the issue in their recently published paper,

Both the beginning and the end of this range remain subject to debate. Some claim that it should extend as low as 0.1nm (because atoms and some molecules are smaller than 1nm) and as high as 300nm (because the unique properties of the nanoscale can also be observed above 100nm). The boundaries of ‘the nanoscale’ are highly significant in both scientific and political terms because they have the possibility to affect everything from funding, to risk assessment and product labelling. [my commentary, Wickson's response, and a citation for the paper, etc. can be found in my July 7, 2010 posting]

There are currently new nanomaterial definitions before the US House of Representatives in one bill and the US Senate in another bill. The House bill specifies (excerpted from my posting of April 27, 2010 where I highlighted a discussion taking place on Andrew Maynard’s’ 2020 science blog),

“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—

(A) chemical structure and composition

(B) size or size distribution

(C) shape

(D) surface structure

(E) reactivity; and

(F) other characteristics and properties that may bear on toxicological properties”

The definitions for nanomaterials/nanoparticles and the defined ranged for the nanoscale have, as Wickson points out, implications for funding, risk assessment, and labelling.

In Canadian terms, there is the Health Canada Interim Policy Statement on [a] Working Definition for Nanomaterialswhich defines the nanoscale as 1 to 100 nm and there is Peter Julian’s tabled bill which defines the nanoscale as 1 to 1000 nm. Neither definition mentions any property other than size. From the Health Canada web page for the interim policy statement,

For the purposes of this definition:

* The term “nanoscale” means 1 to 100 nanometres, inclusive;

* The term “nanoscale phenomena” means properties of the product, material, substance, ingredient, device, system or structure which are attributable to its size and distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,

* The term “manufactured” includes engineering processes and control of matter and processes at the nanoscale. [emphases mine]

As for Peter Julian’s proposed definition (excerpted from my March 24, 2010 posting),

The following are the key components of Bill C-494:

A) A definition of Nanotechnology definition based on “nanometre scale” (1-1000nm)

B) Prescribed Government of Canada research and studies, with the precautionary principle providing direction for a ‘life-cycle’ approach to nanotechnology, and,

C) A Nanotechnology Inventory established and published.

In my July 6, 2010 posting I noted the recent report to the European Parliament for setting a regulatory framework advised this,

The report discusses possible elements of a definition aiming at reducing ambiguity and confusion for regulators, industry and the general public. It recommends that the specific term “particulate nanomaterial” should be employed in legislation to avoid inconsistencies with other definitions and that size should be used as the only defining property.

As I noted July 6, I am not thrilled with the idea of limiting the definitions to size only as I believe it will lead to problematic implementation for the legislation.

Back to the task at hand, i.e., offering samples from the UK House of Lords debate. There’s this from,

The Earl of Selborne: My Lords, the whole House will be grateful to the noble Lord, Lord Krebs. It is not easy to explain just how small a nanoparticle is, but I think he put that into perspective. I am enlightened to know that you can get 300 million nanoparticles on the head of a pin; that is a useful bit of information. Noble Lords will gather that we were very well served by our Chairman; I was very privileged to serve on this sub-committee. The noble Lord, Lord Krebs, with his experience at the Food Standards Agency, could not have been better equipped to undertake the chairing of this really quite complicated but very important subject. [emphasis mine]

A little sarcasm, eh? More seriously, he had this to say,

I ask my noble friend the Minister not for more money-that would clearly be unreasonable-but simply for the considerable sums of money that are spent on nanotechnology research to be partially reallocated, even in small measure, so that the health and safety issues are adequately addressed. The amount of money that we are talking about is very small compared with the development of these new technologies.

In 2007-08 I chaired a working group of stakeholders charged with drafting a voluntary code on good practice for organisations involved in the supply chain for nanotechnologies. The group included research organisations such as the Royal Society through to retailers, trade unions, consumer groups, and of course companies interested in nanotechnologies. We produced a draft nano code that was accepted with a degree of enthusiasm by all the stakeholders. The repeated mantra in all this was “Transparency, accessibility and accountability”-you cannot repeat it too often. Never hide from the public any shortcomings in the scientific knowledge-there are always some. Never try to persuade the public that the risks are less than might otherwise be thought. Be honest. This is something that the Food Standards Agency got off to a good start with after so many food scares when the regulatory authority was the Ministry of Agriculture, Fisheries and Food.

It is disappointing to find that this fundamental lesson does not appear to have been adopted by the food industry, either here or in America.

From Baroness O’Neill of Bengarve,

The questions that are raised by the introduction of new technologies-in particular very novel technologies that are not well understood-into food processing link basic and applied scientific research, knowledge transfer, innovation in manufacturing, the fate of a very large part of the British economy and the daily consumption of food by each one of us. The human and economic consequences of getting matters wrong could be large, ranging from failure to adopt food technologies that may be useful for human health, to failure to co-ordinate work on the scientific basis of nanotechnologies, to failure to build on the achievements of UK scientists, to a considerable loss of competitive advantage by the UK food processing industry, not to mention the possibility of failure to adjust regulation to focus accurately on the risk assessment that will be needed.

I am no friend of excessive regulation, and like many who have run a small institution, I know its costs all too well. However, there are cases in which laissez-faire and market solutions will not work. Public health is a public good, often not achievable by the interplay of market forces and consumer choice alone. The long-running battle between the FSA and the food industry over labelling illustrates-if it illustrates nothing else-that there are those in the food industry who prefer to communicate, or at least pretend to communicate, in ways that demonstrably are not understood by many consumers and indeed may not be comprehensible to many consumers. Mere labelling will not be enough to secure public acceptance of food products containing nanoparticles, despite the fact that nanoparticles are found in many naturally occurring products, including traditional foods-and the sub-committee was told that ricotta cheese contains many of them. We need a more thoughtful approach.

Lord Crickhowell had these comments,

Finally, I say how strongly we felt-this has been said by other noble Lords-about the importance of the industry being open about what it is doing and positive in its communication with the public. The evidence that we received was depressing. Large firms that should have learnt lessons from the GM disaster, for a variety of reasons, seemed to be continuing down the route that led to the disaster. If they do not trust the public, the public will not trust them. The New Scientist, in May, contained a report that stated that a Unilever spokesperson,

“won’t say what nanofoods Unilever is looking into. Two other food multinationals, Kraft and Nestle, declined to talk about their research in the area at all”.

Nothing seems to have changed.

My honourable friend David Willetts, the science Minister who gave evidence earlier today to the Science and Technology Committee, made an interesting observation in his recent speech delivered to the Royal Institution. He was not talking about nanotechnology, but synthetic biology. He said:

“The UK Research Councils had the foresight to hold a public dialogue about ramifications of synthetic biology ahead of Craig Venter developing the first cell controlled by synthetic DNA. This dialogue showed that there is conditional public support for synthetic biology. There is great enthusiasm for the possibilities associated with this field, but also fears about controlling it and the potential for misuse”.

Those words could be applied exactly to nanotechnology and the evidence we received from Which? [UK public engagement project] confirmed it.

There’s more in the Hansard and I found it to be quite interesting as others comment on differences between the UK and the US and there’s more discussion about the implications of the technology and the food industry’s secrecy in light of GMO (genetically modified organisms) and synthetic biology.

Tags: Baroness O'Neill of Bengarve, Earl of Selborne, European Parliament, GMO, Hansard, Health Canada, Interim policy statement on Health Canada's Working Definition for Nanomaterials, Lord Crickhowell, Lord Krebs, nanomaterials, Nanotechnologies and Food: Science and Technology Committee Report, Peter Julian, synthetic biology, UK House of Lords, US House of Representatives, US Senate
Posted in nanotechnology, public engagement, public perceptions, regulation, science communication | No Comments »

Europeans to label engineered nano-scale ingredients in food

Monday, July 12th, 2010

According to a news item on Nanowerk,

The European Parliament has demanded mandatory labelling of all products containing nano ingredients and acknowledged that specific methods to test the safety of nanomaterials are needed. Until these methods are available, food containing nanomaterials should not enter the EU market.

More specifically, Members of the European Parliament voted on this measure July 7, 2010,

The European Parliament agreed that nano-sized ingredients and food from nanotech processes should be subject to novel foods regulations. They furthermore called for a moratorium until specifically-designed risk assessment of nanotechnology processes or nano-ingredients can prove them to be safe, expressing concerns that nanotechnology is already being used in food and food packaging. Any approved nano-ingredients should be mentioned on food labels.

I wonder what impact this legislation will have elsewhere including Canada.

Tags: European Parliament, legislative impact elsewhere, nano food labeling
Posted in food, nanotechnology, regulation | No Comments »

Regulating nanomaterials according to the US GAO and EPA

Thursday, July 8th, 2010

It’s been a banner week for information about nanomaterials regulation. As I noted yesterday, the US General Accountability Office has just released its report titled Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk. Hats off to the authors: Anu Mittal, lead author, and Elizabeth Erdmann, David Bennett, Antoinette Capaccio, Nancy Crothers, Cindy Gilbert, Gary Guggolz, Nicole Harkin, Kim Raheb, and Hai Tran.

In discussing some of the oversight and regulatory issues associated with nanotechnology and other emerging technologies they had this to say (from the report),

Nanotechnology is an example of a fast-paced technology that poses challenges to agencies’ policy development and foresight efforts. We have conducted past work looking at the challenges of exercising foresight when addressing potentially significant but somewhat uncertain trends,5 including technology-based trends that proceed at a high “clockspeed,” that is, a (1) faster pace than trends an agency has dealt with previously or (2) quantitative rate of change that is either exponential or exhibits a pattern of doubling or tripling within 3 or 4 years, possibly on a repeated basis.6 As our prior work has noted, when an agency responsible for ensuring safety faces a set of potentially significant high-clockspeed technology-based trends, it may successfully exercise foresight by carrying out activities such as

• considering what is known about the safety impact of the trend and deciding how to respond to it;

• reducing uncertainty as needed by developing additional evidence about the safety of the trend; and

• communicating with Congress and others about the trends, agency responses, and policy implications.

Similarly, our 21st Century Challenges report raised concern about whether federal agencies are poised to address fast-paced technology-based challenges. [GAO, 21st Century Challenges: Reexamining the Base of the Federal Government, GAO-05-325SP (Washington, D.C.: February 2005)] Other foresight literature illustrates the potential future consequences of falling behind a damaging trend that could be countered by early action. These analyses suggest that unless agencies and Congress can stay abreast of technological changes, such as nanotechnology, they may find themselves “in a constant catch-up position and lose the capacity to shape outcomes.” (p.7/8 print version, p. 11/2 PDF)

(Seems to me the Canadian government could also do with some thoughtful consideration of fast-changing technologies and the challenges they pose to the institutional oversight mechanisms currently in place.)

The report goes on to describe various nano-enabled product categories in various industry sectors. It’s an overview that includes products (e.g. nano-enabled cell phones) currently or soon-to-be on the market. I was particularly taken with an image of a cell phone that tagged parts already nano-enabled (on some models) along with parts that may, in the future, become nano-enabled (p. 14 print version or p. 18 PDF).

The toxicity roundup is one of the best presentations I’ve seen. For example,

Size. Research assessing the role of particle size on toxicity has generally found that some nanoscale (<100 nanometers) particles are more toxic and can cause more inflammation than conventionally scaled particles of the same composition. Specifically, some research indicates that the toxicity of certain nanomaterials, such as some forms of carbon nanotubes and nanoscale titanium dioxide, may pose a risk to human health because these materials, as a result of their small size, may be able to penetrate cell walls, causing cell inflammation and potentially leading to certain diseases. For example, the small size of these nanomaterials may allow them to penetrate deeper into lung tissue, potentially causing more damage, according to some of the studies we reviewed. In addition, some nanomaterials may disperse differently into the environment than conventionally scaled materials of the same composition because of their size. However, according to EPA, the small particle size may also cause the nanomaterials to agglomerate, which may make it more difficult for them to penetrate deep lung tissue. (pp. 23/4 print version, pp. 27/8 PDF)

This a much more measured but still cautious approach to the toxicology issues as they relate to size and this approach is maintained throughout.

There’s more than one way to be exposed,

In addition to toxicity, the risk that nanomaterials pose to humans and the environment is also affected by the route and extent of exposure to such materials. Nanomaterials can enter the human body through three primary routes: inhalation, ingestion, and dermal penetration. (p. 25 print version, p. 29 PDF)

They also make the distinction between exposure as a consequence of consuming products and exposure due to occupation.

Moving on from toxicity, their section on the international scene wowed me because this is the only report I’ve seen which notes that Canada’s nanomaterials inventory has yet to occur.

One thing I hadn’t realized was how similar Environment Canada’s and the US Environmental Protection Agency’s approach to nanomaterials has been. From my April 2, 2010 posting,

Here’s what Environment Canada has to say about nanomaterials (the information on this page is dated from 2007 …) NOTE: The page originally cited is no longer available, go to this page,

The Domestic Substances List (DSL) is the sole basis for determining whether a substance is new. Any chemical or polymer not listed on the DSL is considered to be new to Canada and is subject to the notification requirements under the Regulations. Substances listed on the DSL do not require notification1 in advance of manufacture in or import into Canada.

The Act and the Regulations apply to new nanomaterials just as any other substance, whether a chemical or a polymer.

…

Substances listed on the DSL whose nanoscale forms do not have unique structures or molecular arrangements are considered existing. Existing nanomaterials are not subject to the Regulations and do not require notification. For example, titanium dioxide [emphasis mine] (CAS No. 13463-67-7) is listed on the DSL and since its nanoscale form does not have unique structures or molecular arrangements, it is not subject to the Regulations.

Compare,

In its 2008 document, EPA stated that a nanomaterial is a new chemical for purposes of regulation under TSCA only if it does not have the same “molecular identity” as a chemical already on the inventory. Under TSCA, a chemical is defined in terms of its particular molecular identity.

…

Thus, because titanium dioxide is already listed on the TSCA inventory, nanoscale versions of titanium dioxide, which have the same molecular formula, would not be considered a new chemical under TSCA, despite having a different size or shape, different physical and chemical properties, and potentially different risks. [emphasis mine] (p. 34 print version, p. 38 PDF)

I gather the EPA adopted the strategy one year after Environment Canada. Given how often the various jurisdictions copy each other’s approaches, I wonder which country (or possibly a jurisdiction such as the European Commission) actually set this strategy.

The report offers an excellent summary of Canada’s current regulatory approach and plans. I’ve reproduced the passage in full here,

Canadian officials have proposed but have not implemented a one-time requirement for companies to provide information on nanomaterials produced in or imported into Canada. Canadian importers and manufacturers would be required to report their use of nanomaterials produced or imported in excess of 1 kilogram. In 2009, Canadian officials reported to the OECD that information required would include chemical and trade name; molecular formula; and any available information on the shape, size range, structure, quantity imported or manufactured, and known or predicted uses. Also required would be any available information on the nanomaterial’s physical and chemical properties—such as solubility in water and toxicological data, among others. Under the proposal, companies could claim information as confidential, but regulators would publish a summary of information provided. Canada plans to use this information to help develop a regulatory framework for nanomaterials and to determine which information requirements would be useful for subsequent risk assessments. Canadian officials stated they originally hoped to issue this requirement in the spring of 2009 but could not predict when it would be implemented.

With regard to current law, a report prepared for the government of Canada in 2008 stated that Canada has no specific requirements for nanomaterials and is considering whether they are needed. However, Health Canada and Environment Canada—two agencies responsible for health and the environment—have taken the first steps in recognizing the potentially unique aspects of nanomaterials. These regulatory agencies are currently relying on existing authority delegated to them through legislation, such as the Canadian Environmental Protection Act, to address nanomaterials. Specifically, in June 2007, Environment Canada released a new substances program advisory announcing that nanomaterials will be regulated under the act’s new substances notification regulations. Per this advisory, any nanomaterial not listed on Canada’s chemical inventory—the Domestic Substances List—or with “unique structures or molecular arrangements” compared to their non-nano counterparts, requires a risk assessment. A review panel of the Canadian Academies found that, while it is not necessary to create new regulatory mechanisms to address the unique challenges presented by nanomaterials, the existing regulatory mechanisms could and should be strengthened in a variety of ways, such as by creating a specific classification for nanomaterials and by reviewing the regulatory triggers that prompt review of the health and environmental effects. (pp. 45/6 print version, pp. 49/50 PDF)

As far as I’m aware, there are no comparable summaries available in Canadian reports available to the public. No doubt there are nits to be picked but all I can say is thank you for giving me the most comprehensive and succinct overview I’ve seen yet of the emerging Canadian regulatory framework for nanomaterials.

For interested parties, there is some additional information about Health Canada’s public consultation on their interim definition of nanomaterials in my April 28, 2010 posting.

Tags: 21st Century Challenges: Reexamining the Base of the Federal Government, Antoinette Capaccio, Anu Mittal, Canada, Canadian framework for nanotechnology regulation, Cindy Gilbert, David Bennett, Elizabeth Erdmann, Environment Canada, GAO, Gary Guggolz, General Accountability Office, Hai Tran, Health Canada, Kim Raheb, Nancy Crothers, nanomaterial inventory, nanomaterials, Nanotechnology: Nanomaterials Are Widely Used in Commerce, Nicole Harkin, social sciences, titanium dioxide, US
Posted in nanotechnology, regulation | No Comments »

US Government Accountability Office chimes in on the nanomaterials regulatory debate

Wednesday, July 7th, 2010

Yet another jurisdiction (US) and government agency (Government Accountability Office [GAO]) has released a report about regulating nanomaterials. From the news item on Nanowerk,

The U.S. Government Accountability Office (GAO) has released a report “Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk” (pdf) in which it recommends that EPA complete its plans to modify its regulatory framework for nanomaterials as needed.

As usual, Canada is mentioned for its ‘nanomaterials inventory plan’ but for the first time it’s described as a plan and not a fait accompli,

Australia and the United Kingdom have undertaken a voluntary data collection approach whereas Canada plans to require companies to submit certain types of information.

Thank you to whoever authored the GAO report for getting it right. Meanwhile, I wonder when the Canadian government will choose to notify Canadians (or at least our companies) of this plan.

If you want an overview of the report do go to Nanowerk; I’ve started reading the report and will comment on it tomorrow.

One last note, I remember (having worked in a library and filed their documents) when GAO stood for Government Accounting Office.

Tags: Canada, EPA, GAO, Government Accountability Office, nanomaterials, nanomaterials inventory, nanomaterials reporting plan, Nanotechnology: Nanomaterials Are Widely Used in Commerce, US, US Environmental Protection Agency
Posted in nanotechnology, regulation | 1 Comment »

Nature and nanotechnology: metaphor and narratives

Wednesday, July 7th, 2010

Thanks to Fern Wickson and her co-authors Khara Grieger and Anders Baun, I get to write about nanotechnology metaphors and narratives as per their paper, Nature and Nanotechnology: Science, Ideology and Policy in the International Journal of Emerging Technologies and Society (open access which means anyone is free to download a copy of the paper).

From the paper’s abstract,

In discussions of nanotechnology, it has become increasingly common to emphasise the importance of ‘responsible governance’. This study focused on the issue of environmental governance and was specifically interested in critically exploring the relationship between nature and nanotechnology. It began by characterising a range of narratives commonly told about nature and nanotechnology and suggested that each of these was a story that began with particular assumptions, values and beliefs and ended in support for particular fields of research.

In other words, the narratives are framing devices rooted in particular values and beliefs which in and of themselves will lead you in a particular direction.

Before I go on, I have to comment about this paper’s discussion of a definition in light of yesterday’s posting about the European Commission’s recommendation for a definition focused on the 1 nm to 100 nm size. From the paper,

Both the beginning and the end of this range remain subject to debate. Some claim that it should extend as low as 0.1nm (because atoms and some molecules are smaller than 1nm) and as high as 300nm (because the unique properties of the nanoscale can also be observed above 100nm). The boundaries of ‘the nanoscale’ are highly significant in both scientific and political terms because they have the possibility to affect everything from funding, to risk assessment and product labelling. [emphases mine] (p. 6 paper version, p. 2 PDF)

By the way, this was a footnote to a very thoughtful introduction of nanotechnology and some of the debates concerning it. From the paper,

Both social and natural scientists regularly invoke the concept of nature when talking about nanotechnology. They do this, however, in a variety of ways, each of which can be understood as a kind of narrative, or story, that begins with particular assumptions, values and beliefs (what we will collectively refer to as ideologies) and ends in support for particular fields of research. While everyone may agree that scientists, policy makers and citizens should work to ensure that nanotechnology does not harm ‘nature’ or ‘the environment’, there are very different ideas about what these concepts mean, what constitutes harm, and the reasons why we might wish to avoid it. When people talk about the relationship between nanotechnology and nature, the ideologies underlying the different narratives – and the way the narratives support particular fields of research – generally remain hidden. Each of the stories is presented as a statement of fact, a description of the way things really are. Seeing the role different ideological matrixes play in these narratives is crucial to understanding what is really at stake in debate and decision-making on nanotechnology. (p. 7 in print version, p. 3 PDF)

Nine narratives are described,

Nanotechnology As Nature [here's the metaphor]

Nanotechnology Inspired By Nature

Nanotechnology Improving On Nature

Nanotechnology Using Nature

Nanotechnology Transgressing Nature

Nanotechnology Restricted By Nature

Nanotechnology Controlling Nature

Nanotechnology Threatening Nature

Nanotechnology Treating Nature

For the purposes of the paper, the authors have focused on two narratives:

Nanotechnology Threatening Nature

Nanotechnology Treating Nature

I noted that the ‘threatening’ narrative was treated first which suggests something about the narrative of the paper itself. Possibilities that come quickly to mind include bias on the writers’ part, it’s a more compelling story due to the inherent conflict, or there’s more information (it was almost double the length of the ‘treating’ narrative).

My one major concern with the paper has to do with the way that the toxicological research was summarized and consolidated. From the report,

Major findings within the field of nanotoxicology include adverse effects from exposure to single and multi-walled carbon nanotubes (CNTs), fullerenes (such as C60), quantum dots and nanoparticles of titanium dioxide (TiO2), zinc oxide (ZnO), silver (Ag), copper oxide (CuO), and iron oxide (Fe2O3) (Handy, Owen & Valsami-Jones 2008; O’Brien & Cummins 2008; Stone et al, 2010). Most studies that investigate human health implications of nanomaterials have focused on respiratory effects, partially due to the asbestos-like characteristics of CNTs (SCENIHR 2007; Li et al. 2007) and indeed, recent studies have confirmed asbestos-like similarity of some multi-walled CNTs in inducing pathogenic behaviour (Poland et al. 2008; Takagi et al. 2008). Ecotoxicity studies performed with nanomaterials have documented adverse effects in several different species, including bacteria, algae, invertebrates, crustaceans, fish, mammals, and a few plant species (Baun et al. 2008a). Most of these studies use species typical for risk assessment processes and in 2009, only 89 published peer-reviewed studies investigated effects of nanomaterials on environmentally-relevant species (Stone et al, 2010). The uptake of nanoparticles into plants, and their subsequent transfer into food chains, is an environmental concern that remains largely uninvestigated, however, one recent study documented negative effects on ryegrass seedling growth and root tissues from the absorption of ZnO nanoparticles on root surfaces (Lin & Xing 2008). (p. 12 in print version, p.8 PDF)

There’s a lot more to the titanium dioxide discussion than you’d guess from reading the preceding paragraph. Nanosunscreens (as I’ve noted previously) are recommended (reluctantly* as they noted in 2009) by the Environmental Working Group over other more conventional sunscreens.

* When we began our sunscreen investigation at the Environmental Working Group, our researchers thought we would ultimately recommend against micronized and nano-sized zinc oxide and titanium dioxide sunscreens. After all, no one has taken a more expansive and critical look than EWG at the use of nanoparticles in cosmetics and sunscreens… July, 9 2009 posting

Getting back to Wickson, et al, in summarizing the ideologies for each narrative the order and 2:1 ratio remains intact. From the conclusion,

When we debate whether nanotechnology will threaten or treat nature, in important ways we are disagreeing about what we think the human relationship to nature is or should be and how we understand the world around us. Seeing the narrative character of the way we describe the relationship between nature and nanotechnology helps make visible the role ideology and values play in shaping scientific research and technological development. This opens a space for science policy to be subject to more broad-based discussion and debate, as well as for decision making in this field to become more reflective. All of this is arguably required if we are to have truly responsible environmental governance of nanotechnology. (p. 18 paper version, p. 14 PDF)

Overall, I find this to be a compelling approach to the discussion about regulation and nanotechnology and hope that it is further pursued. Perhaps next time the authors could reveal the secrets behind their own narrative strategies and provide some insight into how their ideologies informed their writing decisions.

ETA July 9, 2010, From Fern Wickson (lead author): Thanks for engaging with our paper in your blog, I appreciate your thoughtful comments and suggestions in terms of revealing our own ideologies and interests in future work.

Of course part of the problem was the limited space we had available
(word length restrictions of the journal) and the breadth of
literature and ideas we were already trying to summarise – as you note
there is certainly more to say about things like the toxicity of
titanium dioxide nanoparticles, much more to say in fact! In terms of
the 2:1 ratio, partly this was simply a feature of the dominance of
this narrative and the amount of research on the topic, however, it is
also partly linked to our prior research interests which have focused
on uncertainties associated with science for policy, how to understand
concepts such as environmental harm, and how to make policy decisions
in the face of uncertainties relating to toxicology. In my case I can
also say that it is because I am personally sceptical of technological
fixes to environmental damage and somewhat concerned about the
potential impacts of nanoparticles. I can not say that these beliefs
are necessarily shared by the other authors though.

In short, I agree with you that it would have been consistent for us
to talk about our own beliefs, assumptions and values and how these
shaped the paper, and while we felt constrained by practicalities, it
could certainly be a good topic for future exploration

Thank you Fern Wickson. I appreciate the discussion of the constraints and some of the issues with writing papers for publication. As we are talking about one’s own beliefs, assumptions and values it seems only fair to reveal a few of my own:

Myself, I’m stuck between the proverbial ‘rock and hard place’. I’m deeply cautious (and on occasion when the hype becomes too much, suspicious) about attempts to ‘fix things’ using technological means given the problems they’ve already caused. I’m pragmatic enough to realize that it hasn’t all been bad news and not all risks and problems can be anticipated. I strongly believe that we need many thinkers and doers working, if not harmoniously, certainly together.

Tags: Anders Baun, Environmental Working Group, EWG, Fern Wickson, Ideology and Policy, Khara Grieger, metaphors, nanosunscreens, narratives, Nature and Nanotechnology: Science, titanium dioxide
Posted in nanotechnology, public engagement, regulation | No Comments »

Europe’s definition of nanomaterials for regulatory purposes? Maybe not so much.

Tuesday, July 6th, 2010

The European Commission has just released a reference report for a definition of nanomaterials which will set the base for a regulatory framework in Europe. From the news item on Nanowerk,

Despite the growing utilisation of engineered nanomaterials in consumer products and innovative technological applications, there is at present no widely accepted definition of the term “nanomaterial” that is suitable as a basis for legislation on their safe use. Responding to a request of the European Parliament, the Joint Research Centre (JRC) published today a reference report entitled “Considerations on a definition of nanomaterial for regulatory purposes” (pdf download).

The report discusses possible elements of a definition aiming at reducing ambiguity and confusion for regulators, industry and the general public. It recommends that the specific term “particulate nanomaterial” should be employed in legislation to avoid inconsistencies with other definitions and that size should be used as the only defining property. [emphases mine]

I have to say I’m a little underwhelmed, especially so after reading (very quickly) the report. The best I can say about the report is that it provides a good summary of the definitions for nanomaterials that have been proposed by various international organizations, government entities, and countries in Europe, as well as, including the US, Canada, and Australia. (I have my fingers crossed that one day there’ll be a report that mentions some other jurisdictions as well.)

Here’s the definition as recommended in the report,

For a definition aimed for regulatory purposes the term ‘nanomaterial’ in its current general understanding is not considered appropriate. Instead, the more specific term ‘particulate nanomaterial’ is suggested.

The term ‘material’ is proposed to refer to a single or closely bound ensemble of substances at least one of which is a condensed phase, where the constituents of substances are atoms and molecules.

For a basic and clear definition of ‘particulate nanomaterial’, which is broadly applicable and enforceable, it is recommended not to include properties other than size.

For the size range of the nanoscale, a lower limit of 1 nm and an upper limit of 100 nm or higher should be chosen.

The questions of size distribution, shape, and state of agglomeration or aggregation, may need to be addressed specifically in subsequently developed legislation. It is also likely that certain particulate materials of concern that fall outside a general definition might have to be listed in specific legislation.

Additional qualifiers, like specific physico-chemical properties or attributes such as ‘engineered’ or ‘manufactured’ may be relevant in the scope of specific regulations. (p. 31 print version, p. 33 PDF)

Given the work in the report, this seems a remarkably modest recommendation that could almost have been written prior. It’s almost as if they made a survey of the current recommendations and pulled together the most commonly occurring and least contentious versions to create a relatively innocuous definition.

Tags: Considerations on a definition of nanomaterial for regulatory purposes, Europe, European Commission, European Parliament, Joint Research Centre, nano definitions, nanomaterials, Regulatory Framework
Posted in nanotechnology, regulation | 1 Comment »

When is a nano-enabled product not nano-enabled?

Monday, July 5th, 2010

Dietram Scheufele over at nanopublic has highlighted some research that David Berube (author of Nanohype—book and blog and professor at the University of North Carolina) and colleagues have published in Nanotechnology Law & Business (research article is behind a paywall). From Dietram’s July 3, 2010 blog posting (I’m unable to link to the specific post, so please scroll to or hunt for the date) about Berube’s research into the Project on Emerging Nanotechnologies’ (PEN) Consumer Products Inventory (CPI),

The article takes a critical look at the Project on Emerging Nanotechnologies (PEN) consumer product inventory. The inventory has been used widely as a gauge of the number and types of nano consumer products currently on the U.S. market.

… [the authors concluded]

“that the CPI is not wholly reliable, and does not have sufficient validity to justify its prominence as evidence for claims associated with the pervasiveness of nanotechnology on the U.S. and global markets. In addition, we caution researchers to approach the CPI with care and due consideration because using the CPI as a rhetorical flourish to amplify concerns about market intrusions seems unjustified.”

In other words, use the CPI with care. Unfortunately, I haven’t been able to read Berube’s paper but I did go to the Project on Emerging Nanotechnologies website and looked at the criteria for inclusion in the CPI where PEN clearly states the inventory’s limitations,

Selection of products

Most products in this inventory satisfy three criteria:

1. They can be readily purchased by consumers, and

2. They are identified as nano-based by the manufacturer OR another source, and

3. The nano-based claims for the product appear reasonable.

In every instance, we have tried to identify specific products from specific producers. However, since nanotechnology has broad applications in a variety of fields, we have included a number of “generic” products that you can find in many places on the market such as computer processor chips. These are clearly labeled in the inventory. In some cases, companies offer several similar nanotechnology-based products and product lines. To reduce redundancy, we have just included a few samples in this inventory and hope that they will provide an initial baseline for understanding how nanotechnology is being commercialized.

There are probably some products in the inventory which producers allege are “nano,” but which may not be. We have made no attempt to verify manufacturer claims about the use of nanotechnology in these products, nor have we conducted any independent testing of the products. We have tried to avoid including products that clearly do not use nanotechnology, but some have undoubtedly slipped through.

Finally, some products are marked “Archive” to indicate that their availability can no longer be ascertained. When these products were added to the inventory we included live links, but since then the company may have discontinued the product, gone out of business, removed a self-identifying “nano” claim or simply changed their web address. In these instances we have attempted to locate a cached version of the product website using The Internet Archive.

I imagine that despite PEN’s clearly statements some folks have referenced it carelessly hence the concern about using it as hype from Berube and his colleagues.

The bit about manufacturers removing the ‘nano’ claim hit home since I did some research into washers that use nanosilver. A friend was disturbed by a recent article about them and I remembered that the US EPA (Environmental Protection Agency) had made a special designation for these types of washers. As it turns out, I got it 1/2 right. From the December 4, 2006 article by Susan Morissey in Chemical and Engineering News,

Silver—claimed to be nanoparticles—employed to kill bacteria in washing machines will now be regulated as a pesticide, EPA announced late last month. Currently, washers that generate silver ions are classified as devices and are not required to be registered with EPA.

The products at issue are Samsung washing machines that are advertised as using silver ions to kill 99.9% of odor-causing bacteria. This technology, called SilverCare, generates ions by applying current to two silver plates housed next to the machine’s tub. The ions are then directed into the tub during the wash cycle.

“EPA has determined that the Samsung silver ion-generating washing machine is subject to registration requirements under the Federal Insecticide, Fungicide & Rodenticide Act,” according to an EPA statement. The agency decided to change the classification of the washer because it releases silver ions into the laundry “for the purpose of killing microbial pests,” the statement explains.

For its part, Samsung has pledged to comply with the change of policy. “Samsung has and will continue to work with EPA and state regulators regarding regulation of the silver washing machine,” the company says.

Several groups concerned about the environmental impact of nanoparticles of silver had asked EPA to reevaluate the way products containing such materials are regulated. For example, environmental group Natural Resources Defense Council (NRDC) noted in a letter to EPA that there are currently more than 40 products on the market in addition to Samsung’s washing machine that have made or implied claims of using nanoparticles of silver to kill bacteria.

NRDC praised EPA for taking what it called a “step in the right direction” by reclassifying nanosilver generated in a washer as a pesticide. The group also said this revised policy should lead to EPA reassessing other products that use nanoparticles of silver for their biocidal qualities.

A pesticide is not exactly a special designation but it certainly is unique as applied to clothes washers. The EPA announcement was made around the US Thanksgiving period (late November) according to a December 6, 2006 article by Scott E. Rickert in Industry Week. From Rickert’s article,

First, let’s backtrack and get the facts behind the headline. The trigger for the EPA decision was a Samsung washing machine. The “SilverWash” contains silver nanoparticles and claims that it helps to kill bacteria in clothes by releasing silver ions into the water during the wash.

Various U.S water authorities became concerned that discharged nanosilver might accumulate in the water system, particularly in wastewater treatment plants where beneficial bacteria are used to purify water of its toxins. This opinion means that nanosilver could be viewed as an environmental pesticide, requiring the product to be registered and tested under the Federal Insecticide, Fungicide and Rodenticide Act. In the words of EPA spokesperson Jennifer Wood, “The release of silver ions in the washing machines is a pesticide, because it is a substance released into the laundry for the purpose of killing pests.”

So what does this really mean to nano-industry? Specifically, we’re not sure yet. It will take several months for the final rules to be detailed in the Federal Register. But some of the early responses have me scratching my head.

One company has removed any reference to nanosilver from their marketing information for antimicrobial devices. Apparently, in the short run, that excludes them from any ruling. As Jim Jones, director of the EPA’s Office of Pesticide Programs, said, “Unless you’re making a claim to kill a pest, you’re not a pesticide.”

This is not a simple ‘good guy vs. bad guy’ situation. Defining nanotechnology, nanoparticles, nanomaterials, etc. is a work in progress which makes attempts to regulate products and production in this area an even earlier work in progress. This situation is not confined to the US or to Canada. In fact, it doesn’t seem to be confined to any one country, which makes the situation applicable globally.

There is work being done and changes instituted, for example, the EPA has announced (from the PEN website),

At an April 29 presentation to the Pesticide Programs Dialogue Committee in Washington, D.C. EPA’s William Jordan announced a new working definition of nanomaterials as “an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” In addition EPA is preparing a Federal Register Announcement due out in June which announces a new interpretation of FIFRA/regulations and proposes a new policy stating that the presence of a nanoscale material in a pesticide product is reportable under FIFRA section 6(a)(2) and applies to already registered products as well as products pending registration.

As well, statements from the NanoBusiness Alliance suggest (in a previous posting on this blog) that there is some support within the business community for thoughtful regulation. As to what thoughtful means in this context, I think that’s something we, as a a society, need to work out.

Tags: clothes washers, Consumer Products Inventory, CPI, David Berube, Dietram Scheufele, Environmental Protection Agency, EPA, Jim Jones, NanoBusiness Alliance, Nanohype, nanopublic, Nanotechnology Law & Business, PEN, Pesticide Programs Dialogue Committee, pesticides, Project on Emerging Nanotechnologies, Richard Jones, Samsung, Scott E. Rickert, silver nanoparticles, Susan Morissey, washing machines, William Jordan
Posted in business, environment, health and safety, nanotechnology, regulation | No Comments »

French Citizen Alliance launches ACEN; a nanotechnology information website

Friday, June 18th, 2010

The new ‘citizen’s’ nanotechnology website is French-language for now although the organizers are hoping to include English-, Spanish-, and Portuguese-language versions. The organization behind this public information effort is called the Citizen Alliance on ChallEnges of Nanotechnologies (CACEN) or Alliance Citoyenne sur les Enjeux des Nanotechnologies (ACEN). From the news item on Nanowerk,

This website will be a place where we will gather questions and concerns about nanotechnologies that citizens and civil society want to raise, and collectively debate and resolve, even while some continue to argue that no regulation or control are possible — because of lack of data (often protected by industry trade secrets) and/or scientific debates about definitions of “nanoparticle” and “nanomaterial,” and scientific uncertainties on how to assess their toxicity, and how to adequately detect and monitor them.

The website offers a global approach on nanotechnologies, presenting the context in which they are developed, funded, and regulated (or not), by whom, and where.

It will open up the “black box” where decisions are being made, to empower civil society by offering resources on current and forthcoming actions, consultations and decision making processes.

Overall, the pluralistic approach of this website makes it unique and original: people involved in a range of environmental, health, and human rights NGOs are contributing.

There is more about the project in the news item where they also ask for help (financial and/or technical) to complete and update their website. I have taken a look at it and, for my taste, they’ve used very engaging visuals (single-line cartoon characters) and colours. At this point, they have five subject areas: Health, Environment, Economy, Ethics, and Democracy. I will have to pull out my dictionary and before going back for further exploration.

Tags: ACEN, Alliance Citoyenne sur les Enjeux des Nanotechnologies, CACEN, Citizen Alliance on ChallEnges of Nanotechnologies, French, nanotechnology website
Posted in nanotechnology, public engagement, regulation, risk | No Comments »

FrogHeart