Posts Tagged ‘nanomaterials’

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US National Institute of Occupational Health and Safety sets recommendations for workplace exposure to carbon nanofibers/nanotubes

Friday, April 26th, 2013

Earlier this week, the US National Institute of Occupational Health and Safety (NIOSH) set recommendations for workplace exposure to carbon nanotubes and carbon nanofibers. According to the Apr. 24, 2013 media advisory from the US Centers for Disease Control and Prevention (NIOSH’s parent agency), the recommendations have been issued in the new Current Intelligence Bulletin (CIB) no. 65. From CIB No. 65,

NIOSH is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnology. As nanotechnology continues to expand into every industrial sector, workers will be at an increased risk of exposure to new nanomaterials. Today, nanomaterials are found in hundreds of products, ranging from cosmetics, to clothing, to industrial and biomedical applications. These nanoscale-based products are typically called “first generation” products of nanotechnology. Many of these nanoscale-based products are composed of engineered nanoparticles, such as metal oxides, nanotubes, nanowires, quantum dots, and carbon fullerenes (buckyballs), among others. Early scientific studies have indicated that some of these nanoscale particles may pose a greater health risk than the larger bulk form of these materials.

Results from recent animal studies indicate that carbon nanotubes (CNT) and carbon nanofibers (CNF) may pose a respiratory hazard. CNTs and CNFs are tiny, cylindrical, large aspect ratio, manufactured forms of carbon. There is no single type of carbon nanotube or nanofiber; one type can differ from another in shape, size, chemical composition (from residual metal catalysts or functionalization of the CNT and CNF) and other physical and chemical characteristics. Such variations in composition and size have added to the complexity of understanding their hazard potential. Occupational exposure to CNTs and CNFs can occur not only in the process of manufacturing them, but also at the point of incorporating these materials into other products and applications. A number of research studies with rodents have shown adverse lung effects at relatively low-mass doses of CNT and CNF, including pulmonary inflammation and rapidly developing, persistent fibrosis. Although it is not known whether similar adverse health effects occur in humans after exposure to CNT and CNF, the results from animal research studies indicate the need to minimize worker exposure.

This NIOSH CIB, (1) reviews the animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of CNT and CNF, (2) provides a quantitative risk assessment based on animal dose-response data, (3) proposes a recommended exposure limit (REL) of 1 μg/m3 elemental carbon as a respirable mass 8-hour time-weighted average (TWA) concentration, [emphasis mine] and (4) describes strategies for controlling workplace exposures and implementing a medical surveillance program. The NIOSH REL is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of CNTs may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.

The recommended exposure, for those of us who can’t read the technical notation, translates to one microgram per cubic meter per eight-hour workday.  In other words, almost zero. Note that this is a recommendation and not a regulation. H/T Apr. 26, 2013 article by Elizabeth Wiese for USA Today

My Mar. 12, 2013 posting highlights some of the NIOSH research which preceded this recommendation.

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Posted in nanotechnology, regulation | 1 Comment »

Free the nano—stop patenting publicly funded research

Friday, November 23rd, 2012

Joshua Pearce, a professor at Michigan Technological University, has written a commentary on patents and nanotechnology for Nature magazine which claims the current patent regimes strangle rather than encourage innovation. From the free article,  Physics: Make nanotechnology research open-source by Joshua Pearce in Nature 491, 519–521 (22 November 2012) doi:10.1038/491519a (Note: I have removed footnotes),

Any innovator wishing to work on or sell products based on single-walled carbon nanotubes in the United States must wade through more than 1,600 US patents that mention them. He or she must obtain a fistful of licences just to use this tubular form of naturally occurring graphite rolled from a one-atom-thick sheet. This is because many patents lay broad claims: one nanotube example covers “a composition of matter comprising at least about 99% by weight of single-wall carbon molecules”. Tens of others make overlapping claims.

…

Patent thickets occur in other high-tech fields, but the consequences for nanotechnology are dire because of the potential power and immaturity of the field. Advances are being stifled at birth because downstream innovation almost always infringes some early broad patents. By contrast, computing, lasers and software grew up without overzealous patenting at the outset.

…

Nanotechnology is big business. According to a 2011 report by technology consultants Cientifica, governments around the world have invested more than US$65 billion in nanotechnology in the past 11 years [my July 15, 2011 posting features an interview with Tim Harper, Cientfica CEO and founder, about the then newly released report]. The sector contributed more than $250 billion to the global economy in 2009 and is expected to reach $2.4 trillion a year by 2015, according to business analysts Lux Research. Since 2001, the United States has invested $18 billion in the National Nanotechnology Initiative; the 2013 US federal budget will add $1.8 billion more.

This investment is spurring intense patent filing by industry and academia. The number of nanotechnology patent applications to the US Patent and Trademark Office (USPTO) is rising each year and is projected to exceed 4,000 in 2012. Anyone who discovers a new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent that prevents others from using that development unless they have the patent owner’s permission.

Pearce makes some convincing points (Note: I have removed a footnote),

Examples of patents that cover basic components include one owned by the multinational chip manufacturer Intel, which covers a method for making almost any nanostructure with a diameter less than 50 nm; another, held by nanotechnology company NanoSys of Palo Alto, California, covers composites consisting of a matrix and any form of nanostructure. And Rice University in Houston, Texas, has a patent covering “composition of matter comprising at least about 99% by weight of fullerene nanotubes”.

The vast majority of publicly announced IP licence agreements are now exclusive, meaning that only a single person or entity may use the technology or any other technology dependent on it. This cripples competition and technological development, because all other would-be innovators are shut out of the market. Exclusive licence agreements for building-block patents can restrict entire swathes of future innovation.

Pearce’s argument for open source,

This IP rush assumes that a financial incentive is necessary to innovate, and that without the market exclusivity (monopoly) offered by a patent, development of commercially viable products will be hampered. But there is another way, as decades of innovation for free and open-source software show. Large Internet-based companies such as Google and Facebook use this type of software. Others, such as Red Hat, make more than $1 billion a year from selling services for products that they give away for free, like Red Hat’s version of the computer operating system Linux.

An open-source model would leave nanotechnology companies free to use the best tools, materials and devices available. Costs would be cut because most licence fees would no longer be necessary. Without the shelter of an IP monopoly, innovation would be a necessity for a company to survive. Openness reduces the barrier for small, nimble entities entering the market.

John Timmer in his Nov. 23, 2012 article for Wired.co.uk expresses both support and criticism,

Some of Pearce’s solutions are perfectly reasonable. He argues that the National Science Foundation adopt the NIH model of making all research it funds open access after a one-year time limit. But he also calls for an end of patents derived from any publicly funded research: “Congress should alter the Bayh-Dole Act to exclude private IP lockdown of publicly funded innovations.” There are certainly some indications that Bayh-Dole hasn’t fostered as much innovation as it might (Pearce notes that his own institution brings in 100 times more money as grants than it does from licensing patents derived from past grants), but what he’s calling for is not so much a reform of Bayh-Dole as its elimination.

Pearce wants changes in patenting to extend well beyond the academic world, too. He argues that the USPTO should put a moratorium on patents for “nanotechnology-related fundamental science, materials, and concepts.” As we described above, the difference between a process innovation and the fundamental properties resulting in nanomaterial is a very difficult thing to define. The USPTO has struggled to manage far simpler distinctions; it’s unrealistic to expect it to manage a moratorium effectively.

While Pearce points to the 3-D printing sector admiringly, there are some issues even there, as per Mike Masnick’s Nov.  21, 2012 posting on Techdirt.com (Note:  I have removed links),

We’ve been pointing out for a while that one of the reasons why advancements in 3D printing have been relatively slow is because of patents holding back the market. However, a bunch of key patents have started expiring, leading to new opportunities. One, in particular, that has received a fair bit of attention was the Formlabs 3D printer, which raised nearly $3 million on Kickstarter earlier this year. It got a ton of well-deserved attention for being one of the first “low end” (sub ~$3,000) 3D printers with very impressive quality levels.

Part of the reason the company said it could offer such a high quality printer at a such a low price, relative to competitors, was because some of the key patents had expired, allowing it to build key components without having to pay astronomical licensing fees. A company called 3D Systems, however, claims that Formlabs missed one patent. It holds US Patent 5,597,520 on a “Simultaneous multiple layer curing in stereolithography.” While I find it ridiculous that 3D Systems is going legal, rather than competing in the marketplace, it’s entirely possible that the patent is valid. It just highlights how the system holds back competition that drives important innovation, though.

3D Systems claims that Formlabs “took deliberate acts to avoid learning” about 3D Systems’ live patents. The lawsuit claims that Formlabs looked only for expired patents — which seems like a very odd claim. Why would they only seek expired patents? …

I strongly suggest reading both Pearce’s and Timmer’s articles as they both provide some very interesting perspectives about nanotechnology IP (intellectual property) open access issues. I also recommend Mike Masnick’s piece for exposure to a rather odd but unfortunately not uncommon legal suit designed to limit competition in a relatively new technology (3-D printers).

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Posted in intellectual property, nanotechnology | 2 Comments »

Figuring out our knowledge gaps (European Agency for Safety and Health at Work) and fillng them (Nanomaterial Registry beta version launched)

Thursday, June 21st, 2012

You (well, I do) get sick of hearing that nanotechnology awareness is low in the general public. Awareness is low in a lot of areas not just nanotechnology. There’s much to choose from and  it takes a lot of work becoming aware let alone becoming knowledgeable, so one tends to pick and choose.

The June 20, 2012 news item on Nanowerk doesn’t provoke much excitement until,

There are serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces, according to a new literature review(pdf [Risk perception and risk communication with regard to nanomaterials in the workplace {European Risk Observatory, Literature Review}]) from the European Agency for Safety and Health at Work (EU-OSHA).

We are facing nanotechnology in our everyday life in many products and applications. Although health and environmental hazards have been demonstrated for some manufactured nanomaterials, they are used in food, cosmetics, textiles, paints, sporting goods, electronics, detergents, and many health and fitness products. And they are present in many workplaces, too.  …

In its review of current research on the subject, EU-OSHA found that communication of the potential risks posed by such materials is still poor, with a majority of Europeans (54%), not even knowing what nanotechnology is. Even in workplaces where manufactured nanomaterials are found, the level of awareness is low. For example, 75% of workers and employers in construction are not aware they work with them. [emphasis mine]

Given that the folks who are at most risk (assuming there is any risk) are the ones who work with the materials, this is disturbing.

The workers who have produced the materials (coatings, etc.) being used by the construction workers are at the most risk as they are exposed to the ‘raw’ nanomaterials.

Once the materials have been constituted as part of a product, the risk level will likely dissipate. Still,  construction workers who apply coatings to various surfaces (e.g. windows) would seem to be at higher risk than people who work in a building with nanotechnology-enabled coated windows that have dried and cured. In any event, the construction workers might take greater care with their industrial hygiene practices if they knew they were working with nanotechnology-enabled products.

The EU-OSHA has an online set of case studies, with a nanotechnology category, illustrating Good Occupational Practices. You can find out more here.  (This reminds me of the International Council on Nanotechnology’s [ICON] Good Nano Guide, which I’ve not mentioned in quite some time. It too focuses on how to handle nanomaterials in an occupational setting.)

This next item is not directly related to occupational health and safety although there could be some crossover. RTI (Research Triangle Institute) International has launched their beta version of a Nanomaterial Registry. From the About the Registry page,

Registry Purpose The purpose of the Nanomaterial Registry project is to:

  • Build a repository of curated nanomaterial information by pulling data from a broad collection of publicly available nanomaterial resources
  • Deliver authoritative and useable information on the biological and environmental interaction of well-characterized nanomaterials
  • Provide tools for matching and analyzing nanomaterial data
  • Improve the quality of nanomaterial information by driving standards of accepted procedures and reporting requirements
  • Promote the use of well-defined minimal information standards framework and common nanomaterial standards
  • Identify reliable information that can be used in regulatory decision making

The June 19, 2012 news item on Nanowerk provides more information,

“The quantity of publicly available literature on nanotechnology is staggering, but until now there has not been a centralized authoritative resource dedicated to nanotechnology research and its implications to biological and environmental systems,” said Michele Ostraat, Ph.D., senior director of the Center for Aerosol and Nanomaterials Engineering at RTI and the project’s principal investigator. “This registry will provide a valuable resource for nanotechnology stakeholders to find and investigate nanomaterials across diverse test methods, protocols and data sources in this field.”

Sponsored by the National Institutes of Health, the registry is designed to improve the quality of and standardization of available methods regarding nanomaterials. This resource will also help researchers create new models, standards and manufacturing methods for nanomaterials and accelerate the development and evaluation of nanomaterials for biomedical and environmental applications.

I have posted about RTI International in the past, most recently in a May 2, 2011 posting.

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Posted in environment, health and safety, nanotechnology, regulation, risk | 1 Comment »

Trent University (Ontario, Canada) and nanosilver toxicology studies

Thursday, May 3rd, 2012

One of the scientists on a research team at Trent University (Ontario, Canada) is claiming that safety questions about nanomaterials are not being asked and so the team is embarking on a study of silver nanoparticles and their impact on a lake ecosystem. From the May 2, 2012 news item on Nanowerk,

Dr. Chris Metcalfe, professor and director of the Institute for Watershed Science at Trent University, is the principal investigator on the Lake Ecosystem Nanosilver (LENS) project with Trent researchers, Drs. Maggie Xenopoulos, Holger Hintelmann and Paul Frost, and colleagues from Fisheries and Oceans Canada and Environment Canada.

“This is a high profile project that will have the eyes of the scientific community on Trent,” said Professor Metcalfe. “We’re fortunate that we have four world-class researchers on our team.” Over the past decade, tiny substances called nanomaterials have become part of our daily lives.

It’s possible that the clothes you’re wearing, or the sunscreen you just applied, contain nanomaterials. Because of this growing use, there is now concern that nanomaterials may pose threats to the environment.

“We have seen an exponential growth in the use of nanomaterials,” said Professor Xenopoulos, an associate professor in the Biology department at Trent University. “However, questions of safety are not being asked.” [emphasis mine]

Likely the claim is a little overenthusiasm or a lack of clarity on the speaker’s part since there has been more than one study about nanosilver particles and safety, including one at Purdue University mentioned in a March 4, 2010 posting on the Beyond Pesticides blog. The Purdue study (The effects of silver nanoparticles on fathead minnow (Pimephales promelas) embryos) is behind a paywall.

Here’s a bit more about silver nanoparticles and the LENS study,

While the benefits of nanomaterials are recognized, we know little about their risks to health and the environment. Due to their extremely small size, nanomaterials interact with cells and organic molecules, raising questions about their impact on organisms.

Due to their antibacterial properties, nanosilver particles are among the most widely-used nanomaterials in consumer goods. Clothing, home appliances, paint, bandages and food storage containers are a few of the products which may contain nanosilver. As we use and dispose of these products, there is a risk that nanosilvers will travel through our municipal water systems into our lakes and rivers.

The research team is working to understand the effect of nanosilver particles on the aquatic environment. Initial laboratory research conducted at Trent indicates that nanosilver can strongly affect aquatic organisms at the bottom of the food chain, such as bacteria, algae and zooplankton.

To further examine these effects in a real ecosystem, the team is conducting a study at the Experimental Lakes Area, near Kenora, in northwestern Ontario.

The LENS project will monitor changes in a lake’s ecosystem that occur after the addition of nanosilver. It will follow nanosilver as it travels through the lake ecosystem, track effects through the entire food web, and determine how resulting changes alter ecosystem function.

There’s more about the LENS project on the Trent University LENS (Lake Ecosystem Nanosilver) Project page (excerpt),

Our previous laboratory research has shown that nanosilver in the aquatic environment first affect organisms at the bottom of the food chain, including bacteria, algae and zooplankton. These responses may have devastating effects upon aquatic ecosystems by reducing overall productivity and altering the cycling of nutrients, such as carbon, nitrogen and phosphorus. There may be compensatory mechanisms within aquatic ecosystems that can mitigate these responses, but it is impossible to predict these responses using laboratory studies. Through support from the Strategic Grants Program of the Natural Sciences and Engineering Research Council of Canada and Environment Canada, a team of researchers from Trent University, Environment Canada and Fisheries and Oceans Canada will conduct a study at the Experimental Lakes Area (ELA) in northwestern Ontario by adding nanoform silver to a small lake over two summer field seasons ion 2013-14. During nano-silver additions, we will monitor the lake for changes to nutrient cycling and the biological effects within the entire food chain. However, in 2012, before starting the lake additions, we will refine our approach by determining what happens in mesocosms (i.e. plastic tubes) that are deployed in lakes. ELA has been used for over 40 years as a living laboratory to study the effects of pollutants in the environment, including past studies of the impacts of pollution from phosphorus, acid deposition, mercury and endocrine disruptors. These studies have resulted in policies to reduce the impacts of pollution. While we do not take lightly the impact that this study will have upon a lake in ELA, this approach is the only way to determine ecosystem level impacts and to influence regulatory policy regarding the ecological risks of NMs.

This is a three-year project, which starts this year (2012).

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Posted in environment, health and safety, nanotechnology, risk | 3 Comments »

Sharing resources: QNano

Wednesday, May 2nd, 2012

This is kind of interesting. There’s a consortium of 15 facilities in several countries in Europe offering access to eligible parties interested in safety testing of nanomaterials. Their second call for transnational access is open until July 31, 2012. From the May 1, 2012 news item on Nanowerk,

The Transnational Access (TA) component for QNano is dedicated to providing Users from the European nanosafety community access to nanomaterials processing, characterisation and exposure assessment facilities (TAFs). Access to 15 major European research sites () is via a single application and evaluation process. Collectively, these sites will enable Users to access small to medium scale equipment and facilities (with the appropriate knowledge to apply them in this context) through to some of the most highly equipped nano-characterization centres in Europe. The central principle of access provision is to offer the Users a full range of services from standard nanomaterials, tuition in best practice, laboratory support and training, and a suite of protocols for all aspects of nanomaterials processing and characterisation in a biological context.

You can find out more about who is and isn’t eligible to use the facilities and exactly where those facilities are at the QNano Transnational Access Facilities webpage. You can respond to this 2nd call by applying for access here (although you do need register for an account if you don’t already have one).

I am a little puzzled by their arithmetic as they state there are 15 facilities in nine countries but I count 10 countries although the UK could be considered a region (except all of those facilities are in England).

Despite the numbers issue (in my mind anyway), it’s nice to see the international cooperation.

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Women in Europe for a Common Future advises precautionary principle for manufacture nanomaterials

Monday, April 2nd, 2012

Another organization advises the precautionary principle when dealing with nanomaterials. This time it’s the Women in Europe for a Common Future (WECF) organization and they’ve just released a position paper. From the March 30, 2012 news item on Nanowerk,

Women in Europe for a Common Future, an international network of over 100 women’s, environmental and health organisations implementing projects in 40 countries and advocating globally for a healthy environment, has released a position paper on nanoparticles and nanotechnology: Nano – The great unknown (pdf).

…

WECF recognizes that nanotechnologies could bring long-term profits and overall societal benefits. However, in order to make an overall judgment, data is needed regarding the hazards, exposure, risks and ethical consequences for humans, the environment and our society as a whole.

Maybe I’m getting grumpy these days but It seems to me that the time for describing ‘nanotechnology as the latest buzzword’ has passed. Here’s the opening sentence from the position paper,

Nanotechnology, the latest buzzword in the global technology revolution, is the science of ‘small things’: the de­signing, manipulating and engineer­ing of materials at nanoscale. (p. 1)

Also on page 1 is a claim as to the number of nanotechnology-enabled products on the market,

The number of consumer products on the world market claiming to contain nanomaterials exceeded 1300 already by 2010, and there are probably more, as the actual presence of nanomaterials is dif­ficult to identify.

The source for the number of nano products is not cited although WECF does list the Project for Emerging Nanotechnologies (PEN) and its product inventory in the bibliography. PEN’s inventory has no oversight (PEN has always been quite frank about this); anyone can register a product and claim there are nanomaterials in it.

Further in the position paper, Canada and California are mentioned,

Other regulatory entities too are work­ing on developing the first laws that can address the concerns on nanomaterials. Canada and the state of California, for example, took the step of imposing mandated disclosure requirements on nanomaterial use and toxicity assess­ment. Canada’s law of January 2009 targets domestic companies and institu­tions that manufacture or buy more than 1 kilogram of nanomaterial per year. According to these new regulations, these entities must now reveal how much nanomaterial they use, how they use it, and what they know about its toxicity. (p. 3)

I’m not familiar enough with the situation in California to comment on it but I am somewhat puzzled by the description of a Canadian law targeting domestic companies and institutions that manufacture or buy more than 1 kilogram of nanomaterials per year. There was a one time only requirement to report on how much nanomaterial was being imported into Canada but, as far as I’m aware, there is no law or regulation which states that this must be done on an ongoing basis. (You can read more about the reporting scheme in my April 12, 2010 posting.) This statement was not cited and I can’t find anything in the bibliography that might be the source for this information.

My problem with this position paper is that I can’t trust any of the information because the little I am familiar with contradicts their statements and they don’t support those statements with sources that I can research.

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US government call for proposals for studies of nanomaterials and occupational health & safety

Thursday, March 8th, 2012

The US National Institute of Occupational Health and Safety (NIOSH) has put out a call for Nanotechnology Studies proposals. From the March 8, 2012 news item on Nanowerk,

The National Institute for Occupational Safety and Health (NIOSH) invites applications from small businesses to conduct innovative research in three high-priority areas, including studies relating to the occupational health and safety aspects of nanotechnology. Applications for competitive funding through the U.S. Department of Health and Human Services’ Small Business Innovative Research (SBIR) program are due by April 5, August 5, and December 5 each year.

So April 5 is the next deadline for a proposal. The wording for the call is a little misleading as two of the three proposed areas of research are nanotechnology-oriented while the 3rd is focused on motor vehicle accidents and incidents. From the March 6, 2012 notice,

The proposed areas for NIOSH research include:

  • Control Technology and Personal Protective Equipment for High Risk Occupations: Research is needed to develop and evaluate control strategies and personal protective equipment for specific hazards and to assure their practicality and usability in workplaces in all industrial sectors with high risk for potentially hazardous exposures. One of the goals of this research area is to evaluate the effectiveness of personal protective equipment in reducing occupational exposures to engineered nanomaterials.
  • Exposure Assessment Methods for High Risk Occupations: Exposure assessment provides strategies and methods to anticipate, recognize, evaluate, control, and confirm effective management of occupational health stressors, exposures to those stressors, and resulting health risks. One of the goals of this research area is the need to support effective assessment of worker exposure to engineered nanomaterials.
  • Occupational Traumatic Injuries from Motor Vehicle Crashes and Incidents: Motor vehicle-related incidents are consistently the leading cause of work-related fatalities in the United States. Priorities include developing new design concepts and standards, enhancing effective interventions for driver education, evaluating intervention strategies for their effectiveness in reducing the number or severity work-related motor vehicle incidents and crashes, and enhancing engineering controls for the prevention of crashes and incidents or reducing the severity of traumatic injury associated with such crashes and incidents.

There is more funding information here (I looked at it briefly but the whole thing seems a bit confusing as I gather it’s part of a ‘ginormous’ government programme, the sort of thing that usually requires hours of patient reading if you’re planning on making a submission). Good luck!

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Posted in health and safety, nanotechnology | 1 Comment »

New nanotechnology standards: ISO/TS 80004-4:2011 and ISO/TS 80004-5:2011

Wednesday, November 23rd, 2011

The International Organization for Standardization (ISO) has released two new standards for terms and definitions. From the Nov. 23, 2011 news item on Nanowerk,

ISO/TS 80004-4:2011 gives terms and definitions for materials in the field of nanotechnologies where one or more components are nanoscale regions and the materials exhibit properties attributable to the presence of those nanoscale regions. It is intended to facilitate communications between organizations and individuals in industry and those who interact with them.

…

ISO/TS 80004-5:2011 lists terms and definitions related to the interface between nanomaterials and biology. It is intended to facilitate communications between scientists, engineers, technologists, designers, manufacturers, regulators, NGOs, consumer organizations, members of the public and others …

ISO/TS 80004-4:2011 can be purchased for 58 Swiss Francs while ISO/TS 80004-5:2011 can be purchased for 50 Swiss Francs.

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Europeans wrangle over nanomaterials definitiion

Thursday, April 14th, 2011

There seems to have been a bit of kerfuffle in Europe about a nanomaterials definition for Europe at the 4th annual Nano Safety for Success Dialogue; Assessing the science & issues at the science/regulation interface workshop which took place March 29 and 30, 2011. From the April 12, 2011 news item on Nanowerk,

The European Commission’s hesitance to define nanotechnology underscores diverging opinions among stakeholders and is causing uncertainty in the sector.

Participants in a Brussels-based international conference, the Safety for Success Dialogue, discussed the Commission’s ongoing search to revise a draft definition of nano that went out to public consultation last year, but made clear that no answer has yet been found.

Henrik Laursen, coordinator of the nano team in the Commission’s environment department, said the EU executive had received around 200 replies to the consultation.

He said: “It is clear that at a certain level many stakeholders are saying different things, and there is no absolute scientific definition.” He said the Commission would not be rushed into making a decision because, once made, it would not be a working model but would immediately have a significant binding effect.

But Chiara Giovanini, a spokeswoman for ANEC, the European Consumer Voice in Standardisation, noted that the “lack of an agreed definition is creating legal uncertainties for regulatory purposes, and hindering the development of adequate safety test and measurement methods”.

She called on the Commission to adopt the draft definition of nanomaterials contained in the consultation at the end of last year “without further delay”.

Unusually for an item of this nature there’s reference to behind the scenes discussions. From the news item,

The Commission is believed to be attempting to frame a definition before the end of the summer. However, the finer detail of how to define nanomaterials is the subject of fervent [emhasis mine] disagreement between stakeholders behind the scenes.

Wim de Jong, vice-chair of the SCENIHR [Scientific Committee on Emerging and Newly Identified Health Risks], told EurActiv that his organisation had recommended to the Commission that the number of particles, rather than the weight of the particles, be used as a guide for determining the definition.

“This is important because the potential hazards of using these particles relates to the number of them within a particular product,” he said.

But other stakeholders are opposed to using numbers as a guide to defining nanomaterials. For example, the European Chemical Industry Council (Cefic) has recommended to the Commission that weight be used instead.

Cefic’s reply to the Commission consultation reads: “Weight is generally used in all chemical legislation and test procedures and should therefore be used instead of particle number concentration.”

Giovanini’s desire to adopt a draft statement for the purposes of getting something done seems similar to the approach Health Canada has taken with its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials.

Laursen’s comment that a draft statement would not be treated as such but instead would have a “significant binding effect,” certainly accords with my experience of how these things work. At the same time, I sympathize with Giovanini’s position as one can’t wait forever to come to an agreement.

I thought the introductory description for the workshop helped to illuminate why details of a dispute which usually remains somewhat behind closed doors have been made public (from the workshop’s introduction page),

Many market modelers identify nanotechnologies as drivers of economic growth. Consequently, most governments in the industrialized and industrializing world adopted ambitious strategic, research and innovation, plans to ensure the commercial success of nanotechnologies and to harvest their fruits.

Nanoscience and the nanotechnologies are progressing at a rapid pace. The number of potential and real applications is increasing rapidly, even when accounting for those claims relating to marketing rather than added-value.

…

The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the OECD Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the Scientific Committee on Emerging and Newly Identified Health Risks of the European Commission. Moreover, a number of regulatory developments have taken place, while the science was also advancing. The European Commission is therefore convening this international conference
• to take stock of the fast advancing science needed for appropriate and effective policies; and
• to analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design …

It’s hard to tell if this is a new introduction or one that’s been used for all of the workshops regardless, it does convey a sense of urgency.

Note: I’ve added the OECD (Organization for Economic Cooperation and Development) link in particular as this has been an excellent source of material about the Canadian situation.

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Posted in nanotechnology, regulation | 3 Comments »

European repository of nanomaterials and first nanoparticle reference material launched

Wednesday, February 23rd, 2011

Reading up on nanotechnology sometimes feels like trying to enter a conversation that’s taking place in code. I understand the English and the overall context but the meaning of significant chunks of the conversation sometimes eludes firm grasp. It’s gotten better over the years but there were a couple of announcements from the European Commission’s Joint Research Centre (JRC) which taken together mildly flummoxed me.

From the Feb. 17, 2011 news item on the Science Business Bulletin,

The European Commission’s Joint Research Centre (JRC) has launched the first European repository of nanomaterials containing 25 different types of nanomaterials. [emphasis mine] This will support safety assessments, which will help to ensure consumer protection and confidence in applications and products based on these materials.

The repository will make it possible to carry out harmonised risk assessment, ensuring standardised methodologies and materials are available, and making it possible to obtain test results that are consistent with tests carried out worldwide. The repository will also provide reliable data for policy and regulatory decision making.

The repository was set up by the JRC in response to needs for safety-assessment testing from experts in the major international standardisation bodies. It contains most types of nanomaterials currently used in significant volumes in consumer products.

Some 8,000 test samples have already been distributed to European national authorities, and EU-funded research projects, and have also been used in international scientific co-operation initiatives. The nanomaterials in the repository are produced in collaboration with the German Fraunhofer Institute for Molecular Biology and Applied Ecology under Good Laboratory Practice conditions. The 25 types of material include carbon nanotubes, silver nanoparticles, titanium dioxide, cerium oxide, zinc oxide, bentonite, gold and silicon dioxide.

You can get more details about the repository from the Joint Research Council (JRC),

Launching the repository officially today, Elke Anklam, Director of the JRC Institute for Health and Consumer Protection (IHCP), said: “This unique repository fosters standardisation in safety assessment and facilitates innovation by creating a common and consistent measurement framework for all stakeholders. This will both support international harmonisation bodies for standardising risk assessment as well as EU policy makers for regulatory issues.”

I’m inferring from this information that using the word nanoparticle isn’t definitive and, for example, the term silver nanoparticle has been used more loosely than I was aware. So logically, the repository holds the standard by which a silver nanoparticle is measured and the 8000 samples that have been sent out from the repository ensure that major players in Europe are using the same standard when analyzing a silver nanoparticle.

Then there was another announcement from the JRC. From the Feb. 18, 2011 news item on Nanowerk,

The European Commission’s Joint Research Centre (JRC) has developed the world’s first certified nanoparticle reference material based on industry-sourced nanoparticles. [emphasis mine] This new material will help ensure the comparability of measurements worldwide, thereby facilitating trade, ensuring compliance with legislation and enhancing innovation.

Nanotechnology offers a range of benefits over traditional materials and enables the development of innovative applications and products. However, there are often concerns about the safety aspects and to what extent these have been investigated. High-quality measurements are the basis for reliable safety assessments, process improvement, quality control and the development of new nanotechnology applications.

Until now, however, no certified benchmarks incorporating industrial nanoparticles were available. Some synthetic materials were available, but they were not fully representative for “real-life” measurements.

For this reason, the JRC’s Institute for Reference Materials and Measurements (IRMM) has produced the world’s first certified reference material based on real-world, industry-sourced nanoparticles. The material (ERM-FD100) consists of silica nanoparticles of a nominal diameter of 20 nanometers (nm). Silica nanoparticles are amongst the most widely used nanoparticles at the moment in products such as polish, whiteners and dispersants.

This material provides the basis for reliable hazard assessments and to check that nanomaterials conform to the internationally accepted definition, as laid down in the respective ISO (International Organisation for Standardisation) technical specification. It will enable producers of nanoparticles to monitor production quality over time against a stable reference point, and to assess the impact of process improvements. Furthermore, the certified reference material will contribute to establishing market confidence, demonstrating that nanomaterial products meet the customers’ technical specifications.

If I understand this rightly, a new material has been created made up of silica nanoparticles with “nominal diameter of 20 nanometers” which can be used as benchmark for measuring nanoparticles of any type. What I don’t understand is the information about the nominal diameter of the silica nanoparticles. Why is this information included but no information about the size of the ‘benchmark’ material (ERM-FD100). Does the 100 stand for something? Also, if there’s a nominal diameter, doesn’t that mean the diameter of the constituent silica nanoparticles might be larger? Following that line of thought further, if the diameters vary, how can you ensure your new material is the size that you claim for it? My guess for the answer to that last question is that all measurements are subject to imperfections and that we get as accurate as we can. If anyone has any answers, thoughts, or guesses to any of my questions, please do make use of the comments section.

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