Tag Archives: Dr. Andrew Maynard

Silver ions in the environment

Earlier this week (Feb. 24, 2014), I published a post featuring Dr. Andrew Maynard, Director of the University of Michigan’s Risk Science Center in an introductory video describing seven surprising facts about silver nanoparticles. For those who want to delve more deeply, there’s a Feb. 25, 2014 news item on Nanowerk describing some Swiss research into silver nanoparticles and ions in aquatic environments,

It has long been known that, in the form of free ions, silver particles can be highly toxic to aquatic organisms. Yet to this day, there is a lack of detailed knowledge about the doses required to trigger a response and how the organisms deal with this kind of stress. To learn more about the cellular processes that occur in the cells, scientists from the Aquatic Research Institute, Eawag [Swiss Federal Institute of Aquatic Science and Technology], subjected algae to a range of silver concentrations.

In the past, silver mostly found its way into the environment in the vicinity of silver mines or via wastewater [emphasis mine] emanating from the photo industry. More recently, silver nanoparticles have become commonplace in many applications – as ingredients in cosmetics, food packaging, disinfectants, and functional clothing. Though a recent study conducted by the Swiss National Science Foundation revealed that the bulk of silver nanoparticles is retained in wastewater treatment plants, only little is known about the persistence and the impact of the residual nano-silver in the environment.

The Feb. 25, 2014 Eawag media release, which originated the news item, describes the research in further detail,

Smitha Pillai from the Eawag Department of Environmental Toxicology and her colleagues from EPF Lausanne and ETH Zürich studied the impact of various concentrations of waterborne silver ions on the cells of the green algae Chlamydomonas reinhardtii. Silver is chemically very similar to copper, an essential metal due to its importance in several enzymes. Because of that, silver can exploit the cells’ copper transport mechanisms and sneak into them undercover. This explains why, already after a short time, concentrations of silver in the intracellular fluid can reach up to one thousand times those in the surrounding environment.

A prompt response

Because silver damages key enzymes involved in energy metabolism, even low concentrations can cut photosynthesis and growth rates by a half in just 15 minutes. Over the same time period, the researchers also detected changes in the activity of about 1000 other genes and proteins, which they interpreted as a response to the stressor – an attempt to repair silver-induced damage. At low concentrations, the cells’ photosynthesis apparatus recovered within five hours, and recovery mechanisms were sufficient to deal with all but the highest concentrations tested.

A number of unanswered questions

At first glance, the results are reassuring because the silver concentrations that the algae are subject to in the environment are rarely as high as those applied in the lab, which allows them to recover quickly – at least externally. But the experiments also showed that even low silver concentrations have a significant effect on intracellular processes and that the algae divert their energy to repairing damage incurred. This can pose a problem when other stressors act in parallel, such as increased UV-radiation or other chemical compounds. Moreover, it remains unknown to this day whether the cells have an active mechanism to shuttle out the silver. Lacking such a mechanism, the silver could have adverse effects on higher organisms, given that algae are at the bottom of the food chain.

You can find the researchers’ paper here,

Linking toxicity and adaptive responses across the transcriptome, proteome, and phenotype of Chlamydomonas reinhardtii exposed to silver by Smitha Pillai, Renata Behra, Holger Nestler, Marc J.-F. Suter, Laura Sigg, and Kristin Schirmer. Proceedings of the National Academy of Sciences (PNAS) – early edition 18.February 2014, www.pnas.org/cgi/doi/10.1073/pnas.1319388111

The paper is available through the PNAS open access option.

I have published a number of pieces about aquatic enviornments and wastewater and nanotechnology-enabled products as useful for remediation efforts and as a source of pollution. Here’s a Feb. 28, 2013 posting where I contrasted two pieces of research on silver nanoparticles. The first was research in an aquatic environment and the other concerned wastewater.

Surprising facts about silver nanoparticles from the University of Michigan

Dr. Andrew Maynard, Director of the University of Michigan’s Risk Science Center, has featured seven surprising facts about silver nanoparticles in his latest video in the Risk Bites series. Before getting to the video,here’s an introduction to the topic of silver nanoparticles from a Feb. 18, 2014 posting by Ishani Hewage on the University of Michigan’s Risk Sense blog (Note: A link has been removed),

Silver – known for its germ-killing capabilities – has been used for thousands of years. In recent times though, concerns have been raised over the potential health and environmental risks associated with one particular form of silver that has been used increasingly in a range of products: engineered silver nanoparticle. In this week’s Risk Bites, Andrew Maynard, director of the Risk Science Center, rounds-up seven aspects of silver nanoparticles that might help you weigh up their risks and benefits.

“Silver has long been used for its medicinal properties,” says Andrew. “People used to intentionally dose themselves with silver nanoparticles in the form a silver laced tonic as a cure-all.”

Nowadays, the use of silver nanoparticles is not just limited to the medical field. The military, athletes and manufactures are increasingly using them to develop smart new technologies that inhibit bacterial growth and enhance overall performance.  These microscopically small particles make it easier to get silver into products without compromising them …

Without more ado, here’s the video, ’7 surprising facts about silver nanoparticles and health’:

Both the blog posting and this link will lead you to more information about silver nanoparticles.

Rising from the dead: the inventory of nanotechnology-based consumer products

The inventory of nanotechnology-based consumer products or the Consumer Products Inventory (CPI) is still cited in articles about nanotechnology and its pervasive use in consumer products despite the fact that the inventory was effectively rendered inactive (i.e., dead) in 2009 and that  it was a voluntary system with no oversight, meaning whoever made the submission to the inventory could make any claims they wanted. Now that it’s 2013, things are about to change according to an Oct. 28, 2013 news item on ScienceDaily,

As a resource for consumers, scientists, and policy makers, the Virginia Tech Center for Sustainable Nanotechnology (VTSuN) has joined the Woodrow Wilson International Center for Scholars to renew and expand the Nanotechnology Consumer Product Inventory, an important source of information about products using nanomaterials.

“We want people to appreciate the revolution, such as in electronics and medicine. But we also want them to be informed,” said Nina Quadros, a research scientist at Virginia Tech’s Institute for Critical Technology and Applied Science and associate director of VTSuN, who leads a team of Virginia Tech faculty members and students on this project. Todd Kuiken, senior program associate, and David Rajeski, director of the science and technology innovation program, lead this project at the Wilson Center.

The Oct. 28, 2013 Virginia Tech (Virginia Polytechnic Institute and State University) news release by Susan Trulove (which originated the news item),provides a brief history of the inventory and a description of its revivification,

The Wilson Center and the Project on Emerging Nanotechnology created the inventory in 2005. It grew from 54 to more than 1,000 products, many of which have come and gone. The inventory became the most frequently cited resource, showcasing the widespread applications of nanotechnology. However, in 2009, the project was no longer funded.

“I used it in publications and presentations when talking about all the ways nano is part of people’s lives in consumer products,” said Matthew Hull, who manages the Institute for Critical Technology and Applied Science’s investment portfolio in nanoscale science and engineering, which includes the Center for Sustainable Nanotechnology. “But the inventory was criticized by researchers, regulators, and manufacturers for the lack of scientific information available to support product claims.”

In a meeting with his friend, Andrew Maynard, director of the University of Michigan Risk Science Center, who had initiated the inventory when he was at the Wilson Center, Hull proposed leveraging Institute for Critical Technology and Applied Science and Center for Sustainable Nanotechnology resources to improve the inventory.

“My role was to ask ‘what if’ and [the Virginia Tech Center for Sustainable Nanotechnology] ran with it,” said Hull.

A partnership was formed and, with funding from the Virginia Tech institute, the Center for Sustainable Nanotechnology restructured the inventory to improve the reliability, functionality, and scientific credibility of the database.

“Specifically, we added scientific significance and usefulness by including qualitative and quantitative descriptors for the products and the nanomaterials contained in these products, such as size, concentration, and potential exposure routes,” said Quadros. For example, an intentional exposure route would be the way a medicine is administered. An unintentional exposure would be when a child chews on a toy that has been treated with silver nanoparticles that are used as an antimicrobial. The potential health effect of nanomaterials on children was Quadros doctoral research and she used the inventory to find products designed for children that use nanomaterials, such as plush toys.

“One of the best things about the new version of the inventory is the additional information and the ability to search by product type or the type of nanomaterial,” she said. “When researchers were first attempting to assess the potential environmental impacts of nanotechnology, one main challenge was understanding how these nanomaterials might end up in the environment in the first place. After searching the CPI and seeing the vast applications of nanotechnologies in consumer products it was easier to narrow down scenarios.”

For example, Quadros said many silver nanoparticles are used in clothing for antimicrobial protection, so we can infer that some silver nanoparticles may end up in wastewater treatment plants after clothes washing. This helped justify some of the research on the effects of silver nanoparticle in the biological wastewater treatment processes. Currently, the inventory lists 188 products under the ‘clothing’ category.”

This team also included published scientific data related to those products, where available, and developed a metric to assess the reliability of the data on each inventory entry.

The team interviewed more than 50 nanotechnology experts with more than 350 combined years of experience in nanotechnology, Quadros said. “Their answers provided valuable guidance to help us address diverse stakeholder needs.”

In addition, the site’s users can log in and add information based on their own expertise. “Anyone can suggest edits. The curator and reviewer will approve the edits, and then the new information will go live,” Quadros said.

“We’ve added the horsepower of [the Center for Sustainable Nanotechnology], but opened it by means of crowdsourcing to new information, such as refuting or supporting claims made about products,” Hull said.

“The goal of this work is to create a living, growing inventory for the exchange of accurate information on nano­enabled consumer products,” Quadros said. “Improved information sharing will allow citizens, manufacturers, scientists, policymakers, and others to better understand how nanotechnology is being used in the consumer marketplace,” she said.

As of October 2013,

The inventory currently lists more than 1,600 consumer products that claim to contain nanotechnology or have been found to contain nanomaterials.

Quadros will give a presentation about the inventory at the Sustainable Nanotechnology Organization conference in Santa Barbara on Nov. 3-5 and will present to the U.S. Environmental Protection Agency and the National Science Foundation in the spring.

Key collaborators at Virginia Tech are Sean McGinnis, an associate research professor in the materials science and engineering department; Linsey Marr, professor of civil and environmental engineering; her postdoc, Eric Vejerano, who was instrumental in development of product categories; and Michael Hochella, a university distinguished professor in the geosciences department and Virginia Tech Center for Sustainable Nanotechnology director.

You can find the Consumer Products Inventory here where it is still hosted by the Woodrow Wilson Center’s Project on Emerging Nanotechnologies. The website for the Second Sustainable Nanotechnology Organization Conference where Quadros will be presenting can be found here and is where this conference description can be found,

The objective of this conference is to bring together scientific experts from academia, industry, and government agencies from around the world to present and discuss current research findings on the subject of nanotechnology and sustainability.

The conference program will address the critical aspects of sustainable nanotechnology such as life cycle assessment, green synthesis, green energy, industrial partnerships, environmental and biological fate, and the overall sustainability of engineered nanomaterials. In principle, this involves the fundamental/applied research on the chemistry of producing new green nanomaterials; eco-manufacturing processing of nanomaterials and products, using nanotechnology to benefit society, and examining possible harmful effects of nanotechnology.

The conference will also foster new collaborations between academic and industrial participants. This community of users, researchers and developers of engineered nanomaterials will provide a long-term, scientific assessment of where the science is for sustainable nano, where it should be heading, and what steps academics, government agencies and others can take now to reach targeted goals. In addition, the conference will serve as the platform to initiate the formation of the Sustainable Nanotechnology Organization (SNO), a non-profit, international professional society dedicated to advancing sustainable nanotechnology through education, research, and promotion of responsible development of nanotechnology.

Finally because I can resist no longer, especially so near to Hallowe’en, I guess you could call the ‘renewed’ CPI, a zombie CPI as it’s back from the dead and it needs brains,

Zombies in Moscow, 26 April 2009 Credit: teujene [downloaded from http://en.wikipedia.org/wiki/File:Zombies_in_Moscow.jpg]

Zombies in Moscow, 26 April 2009 Credit: teujene [downloaded from http://en.wikipedia.org/wiki/File:Zombies_in_Moscow.jpg]

Beginner’s guide to carbon nanotubes and nanowires

There’s a very nice Apr. 11, 2013  introductory article by David L. Chandler for the Massachusetts Institute of Technology (MIT) news office) about carbon and other nanotubes and nanowires,

The initial discovery of carbon nanotubes — tiny tubes of pure carbon, essentially sheets of graphene rolled up unto a cylinder — is generally credited to a paper published in 1991 by the Japanese physicist Sumio Ijima (although some forms of carbon nanotubes had been observed earlier). Almost immediately, there was an explosion of interest in this exotic form of a commonplace material. Nanowires — solid crystalline fibers, rather than hollow tubes — gained similar prominence a few years later.

Due to their extreme slenderness, both nanotubes and nanowires are essentially one-dimensional. “They are quasi-one-dimensional materials,” says MIT associate professor of materials science and engineering Silvija Gradečak: “Two of their dimensions are on the nanometer scale.” This one-dimensionality confers distinctive electrical and optical properties.

For one thing, it means that the electrons and photons within these nanowires experience “quantum confinement effects,” Gradečak says. And yet, unlike other materials that produce such quantum effects, such as quantum dots, nanowires’ length makes it possible for them to connect with other macroscopic devices and the outside world.

The structure of a nanowire is so simple that there’s no room for defects, and electrons pass through unimpeded, Gradečak explains. This sidesteps a major problem with typical crystalline semiconductors, such as those made from a wafer of silicon: There are always defects in those structures, and those defects interfere with the passage of electrons.

H/T Nanowerk Apr. 11, 2013 news item. There’s more to read at the MIT website and I recommend this as a good beginner’s piece since the focus is entirely on what carbon nanotubes and nanowires are , how they are formed, and which distinctive properties are theirs. You can find some of this information in the odd paragraph of a news release touting the latest research but I’m very excited to find this much explanatory material in one place.

Another very good explanatory piece, this one focused on carbon nanotubes and risk, is a video produced by Dr. Andrew Maynard for his Risk Bites series. I featured and embedded it in my Mar. 15, 2013 posting. titled, The long, the short, the straight, and the curved of them: all about carbon nanotubes.  You can also find the video in Andrew’s Mar. 14, 2013 posting on his 2020 Science blog where he also writes about the then recently released information from the US National Institute of Occupational Health and Safety on carbon nanotubes and toxicity.

The long, the short, the straight, and the curved of them: all about carbon nanotubes

I implied a question in my Mar. 12, 2013 post about the recent announcement from the US National Institute of Occupational Health and Safety (NIOSH) concerning a carbon nanotube toxicity study. I indicated some curiosity about the length of the multi-walled carbon nanotubes studied in this latest research. Coincidentally, Dr. Andrew Maynard (Executive Director of the University of Michigan Risk Science Center answered this implied question in his Mar. 14, 2013 posting about the study (on Andrew’s 2020 Science blog),

The carbon nanotubes in this study were inhaled multi-walled carbon nanotubes with a predominantly long, straight fiber-like morphology.  Mice were exposed at a level of 5 mg/m3 for 5 hours per day, over a 15 day period.

It’s well worth reading Andrew’s posting for the context he provides about the research and for links to further information.

For anyone who wants the short story, multi-walled carbon nanotubes (predominantly the long, straight fibre-type were used in the study) when combined with a known cancer-initiating chemical are more toxic than plain carbon nanotubes. The study has yet to be published but the results were discussed at the Society of Toxicity’s 2013 annual meeting.

Happily, he also provides this charming video (part of his Risk Bites video series) describing carbon nanotubes and their ‘infinite’ variety,

Thank you Andrew for clearing up some of my longstanding questions about carbon nanotubes.

Happy weekend to all!

Looking blue? Maybe it’s silver nanoparticles

Looking blue can mean feeling sad or it can indicate that you have argyria, a condition caused by ingesting too much silver. An Oct. 29, 2012 news item on Nanowerk about research on argyria taking place at Brown University reveals the latest insight on the cause for this condition,

Researchers from Brown University have shown for the first time how ingesting too much silver can cause argyria, a rare condition in which patients’ skin turns a striking shade of grayish blue.

“It’s the first conceptual model giving the whole picture of how one develops this condition,” said Robert Hurt, professor of engineering at Brown and part of the research team. “What’s interesting here is that the particles someone ingests aren’t the particles that ultimately cause the disorder.”

Scientists have known for years argyria had something to do with silver. The condition has been documented in people who (ill advisedly) drink antimicrobial health tonics containing silver nanoparticles and in people who have had extensive medical treatments involving silver. Tissue samples from patients showed silver particles actually lodged deep in the skin, but it wasn’t clear how they got there.

As it turns out, argyria is caused by a complex series of chemical reactions, Hurt said. His paper on the subject, authored with Brown colleagues Jingyu Liu, Zhongying Wang, Frances Liu, and Agnes Kane, is published in the journal ACS Nano (“Chemical Transformations of Nanosilver in Biological Environments” [behind a paywall]).

The Oct. 25, 2012 Brown University news release (which originated the news item) provides more detail,

Hurt and his team have been studying the environmental impact of silver, specifically silver nanoparticles, for years. They’ve found that nanosilver tends to corrode in acidic environments, giving off charged ions — silver salts — that can be toxic in large amounts. Hurt’s graduate student, Jingyu Liu (now a postdoctoral fellow at the National Institute of Standards and Technology), thought those same toxic ions might also be produced when silver enters the body, and could play a role in argyria.

To find out, the researchers mixed a series chemical treatments that could simulate what might happen to silver inside the body. One treatment simulated the acidic environment in the gastrointestinal tract; one mimicked the protein content of the bloodstream; and a collagen gel replicated the base membranes of the skin.

They found that nanosilver corrodes in stomach acid in much the same way it does in other acidic environments. Corrosion strips silver atoms of electrons, forming positively charged silver salt ions. Those ions can easily be taken into the bloodstream through channels that absorb other types of salt. That’s a crucial step, Hurt said. Silver metal particles themselves aren’t terribly likely to make it from the GI tract to the blood, but when they’re transformed into a salt, they’re ushered right through.

From there, Hurt and his team showed that silver ions bind easily with sulfur present in blood proteins, which would give them a free ride through the bloodstream. Some of those ions would eventually end up in the skin, where they’d be exposed to light.

To re-create this end stage, the researchers shined ultraviolet light on collagen gel containing silver ions. The light caused electrons from the surrounding materials to jump onto the unstable ions, returning them to their original state — elemental silver. This final reaction is ultimately what turns patients’ skin blue. The photoreaction is similar to the way silver is used in black and white photography [emphasis mine]. When exposed to light, silver salts on a photographic film reduce to elemental silver and darken, creating an image.

While I find the notion that the body’s reaction to silver is similar to the processing of silver in black and white photography, it’s the discussion about toxicity that most interests me. The scientists at Brown are suggesting that   standard ‘ingestable’ silver could be more dangerous than silver nanoparticles when they are consumed in the body,

This research, however, “would be one piece of evidence that you could treat nanoparticles in the same way as other forms of silver,” Hurt says.

That’s because the bioavailable form of silver — the form that is absorbed into the bloodstream — is the silver salt that’s made in the stomach. Any elemental silver that’s ingested is just the raw material to make that bioavailable salt. So ingesting silver in any form, be it nano or not, would have basically the same effect, Hurt said.

“The concern in this case is the total dose of silver, not what form it’s in,” Hurt said. “This study implies that silver nanoparticles will be less toxic than an equivalent amount of silver salt, at least in this exposure scenario [emphasis mine].”

This research provides more evidence supporting Dr. Andrew Maynard’s contention that creating definitions and regulations for nanomaterials based on size may not be the best approach. Here’s his response to my question (in an Oct. 24, 2011 posting) about the then newly adopted Health Canada definition (which includes size) for nanomaterials,

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

One can only wait as the evidence continues to mount on one side or the other. In the meantime, I don’t one can ever go wrong with BB King, one of the great blues guitar players (Blues Boys Tune),

Nano regulatory frameworks are everywhere!

The scene around nanotechnology regulatory frameworks has been frantic (by comparison with any other time period during the 3 years I’ve been blogging about nano) in the last month or so. This is my second attempt this month at pulling together information about nanotechnology regulatory frameworks (my June 9, 2011 posting).

I’ll start off slow and easy with this roundup of sorts with a brief look at the international scene, move on to US initiatives, offer a brief comment on the Canadian situation, and wrap up with Europe.

International

Dr. Andrew Maynard at the University of Michigan Risk Science Center (UMRSC) blog has written a commentary about the ISO’s (*International Organization for Standardization) latest set of nanotechnology guidelines in his May 27, 2011 posting.  From the posting,

ISO/TR 31321:2011: Nanotechnologies – Nanomaterial risk evaluation is unashamedly based on the Environmental Defense Fund/DuPont Nano Risk Framework. Much of the structure and content reflects that of the original – a testament to the thought and effort that went into the first document. …The ISO report is written in a much tighter style than that of the original document, and loses some of the occasionally long-winded expositions on what should be done and why. And the ISO document is more compact – 66 pages as opposed to 104. But from a comparative reading, surprisingly little has been changed from the 2007 document.

It’s build around a framework of six steps:

  1. describe materials and applications
  2. material profiles
  3. evaluate risks
  4. assess risk management options
  5. decide, document, and act
  6. review and adapt

From the posting,

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

Andrew’s view of these guidelines is largely positive and you can get more details and history by viewing his original commentary. (I first mentioned these new ISO guidelines in my May 18, 2011 posting.)

Sticking with the international scene (in this case, ISO), there was a June 13, 2011 news item on Nanowerk about a new ISO general liability classification for nanotechnology and alternative energy (from the news item),

The new classifications to address the growing use of nanotechnology are Nanomaterial Distributors and Nanomaterial Manufacturing. The once-limited use of nanotechnology in electronics and information technology industries is now swiftly permeating the consumer marketplace, from cosmetics to clothing and more. The Nanomaterial Distributors classification applies to risks that sell nanomaterials to others, and the Nanomaterial Manufacturing classification applies to risks that manufacture or engineer nanomaterials for others.

“With heightened interest to reduce the carbon footprint, establish energy independence, and increase the use of renewable resources, alternative power is a priority for many,” said Beth Fitzgerald, vice president of commercial lines and modeling at ISO. “In response to the growing demand for alternative energy, ISO introduced classifications for risks in three main areas: biofuels, solar energy, and wind energy. The new classifications will allow for future evaluation of the loss experience of those emerging markets.”

The biofuels classifications consist of Biofuels Manufacturing and Biofuels Distributors. Since ethanol already has a widespread and accepted use, a further distinction is made between “ethanol” and “biofuels other than ethanol.”

The solar energy classifications include Solar Energy Farms, Solar Energy Equipment Dealers or Distributors, and Solar Energy Equipment Manufacturing. The wind energy classifications include Wind Turbine Contractors – Installation, Service, or Repair and onshore and offshore Wind Farms.

* I have for many years understood that ISO is the International Standards Organization and I see from a note on the UMRSC blog that these days it is the International Organization for Standardization.

US

On the US front, three different agencies have made announcements that in one way or another will have an impact on the nanotechnology regulatory frameworks in that country.

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) recently released a set of principles for the regulation and oversight of nanotechnology applications and guidance for the development and implementation of policies at the agency level. From the June 9, 2011 news item on Nanowerk,

The realization of nanotechnology’s full potential will require continued research and flexible, science-based approaches to regulation that protect public health and the environment while promoting economic growth, innovation, competitiveness, exports, and job creation.

In furtherance of those goals, the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

These principles reinforce a set of overarching principles (pdf) for the regulation and oversight of emerging technologies released on March 11, 2011. They also reflect recommendations from a report on nanotechnology (pdf) by the President’s Council of Advisors on Science and Technology. The report encourages Federal support for the commercialization of nanotech products and calls for the development of rational, science- and risk-based regulatory approaches that would be based on the full array of a material’s properties and their plausible risks and not simply on the basis of size alone.

You can read more about the guidelines at Nanowerk or on the Environemental Expert website here.

Back over on the UMRSC blog, Dr. Andrew Maynard had these comments in his June 13, 2011 posting,

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

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

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

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

June 9, 2011 was quite the day as in addition to the White House documents, the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) both announced public consultations on nanotechnology regulation.

From the June 9, 2011 news item on Nanowerk about the US EPA public consultation,

The U.S. Environmental Protection Agency announced today it plans to obtain information on nanoscale materials in pesticide products. Under the requirements of the law, EPA will gather information on what nanoscale materials are present in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The proposed policy will be open for public comment.

“We want to obtain timely and accurate information on what nanoscale materials may be in pesticide products, “said Steve Owens assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “This information is needed for EPA to meet its requirement under the law to protect public health and the environment.”

Comments on the Federal Register notice will be accepted until 30 days after publication. The notice will be available at www.regulations.gov in docket number EPA–HQ–OPP–2010-0197. More information or to read the proposed notice: http://www.epa.gov/pesticides/regulating/nanotechnology.html [Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment]

The US FDA has taken a more complicated approach to its public consultation with two notices being issued about the same consultation. The June 9, 2011 news item on Nanowerk had this to say,

The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

Then there was a June 15, 2011 news item on Nanowerk offering more details about the draft guidance announcement of June 9, 2011,

The guidelines list things that might be considered when deciding if nanotechnology was used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are.

And FDA wants industry leaders and the public to weigh-in.

Nanotechnology—the science of manipulating materials on a scale so small that it can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics. “Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial.”

In other words, using nanotechnology can change the way a product looks or operates, Peña says.

Although the technology is still evolving, it’s already in use as display technology for laptop computers, cell phones, and digital cameras. In the medical community, a number of manufacturers have used nanotechnology in:

  • Drugs
  • Medical imaging
  • Antimicrobial materials
  • Medical devices
  • Sunscreens

Andrew Maynard in his previously noted June 13, 2011 posting on on the UMRSC blog had this to say  about the EPA’s draft document,

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

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

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

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

Canadian segue

I’ll point out here that Health Canada’s Interim Policy definition also adheres to the 1 to 100 nm definition for a nanomaterial, a concern I expressed in my submission to the public consultation held last year. Interestingly, since 29 submissions does seem particularly daunting to read there has yet to be any public response to these submissions. Not even a list of which agencies and individuals made submissions.

Back to US

Andrew also comments on the FDA document,

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

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

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

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

I recommend reading the full text of Andrew’s comments.

Europe

Meanwhile, there was a June 10, 2011 news item on Nanowerk about the availability of  28 presentations from a May 10-12, 2011 joint European workshop hosted by the Engineered NanoParticle Risk Assessment (ENPRA) FP (Framework Programme) 7 project and the European Commission’s Joint Research Centre. From the news item about the Challenges of Regulation and Risk Assessment of Nanomaterials workshop,

Twenty-eight presentations delivered at the Joint JRC Nano event and 2nd ENPRA Stakeholders Workshop are now available on-line: ENPRA Workshop 2011 – Programme with Presentations.

The workshop (by invitation only) involved about 90 participants, from industry, government, NGOs, and academia. …

During two days and a half, 34 experts from 26 different organisations informed the participants on the latest scientific progress in the field of nanoparticles risk assessment produced within national and European projects, and first results of ENPRA FP7 project were presented in detail. In addition, recent developments concerning legislation in the EU and beyond were discussed.

Amongst other participants, you can include representatives of EU Associate and Candidate Countries, environment and workers’ protection organisations, CAIQ (Chinese Academy of Inspection and Quarantine), US-EPA, ECHA, and EFSA.

To close this piece (and I want to do that very badly), I’m going to give Tim Harper at his TNT blog (on the Cientifica website) the final word from his June 10, 2011 posting,

The White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles (pdf) specific to the regulation and oversight of applications of nanotechnology, to guide the development and implementation of policies at the agency level.

I’m glad to see that it addresses those two old bugbears, the confusion between risk and hazard and the prejudging of issues without reference to scientific evidence …

It is an approach which appears to diverge slightly from the European adoption of the precautionary principle …

As with any regulation, the problems will arise not from the the original wording, but through its (mis)interpretation and inconsistent application.

Nanomaterial regulatory frameworks: what’s all the fuss?

I’ve dug up more information on nanomaterials and regulatory frameworks but before I launch off into the discussion I think it might be interesting to take a look at this graphic of a plant’s potential uptake of various nanomaterials as it illustrates some of the reasons why there’s so much interest in this topic.

Downloaded from the June 7, 2011 article, Nano & The Food Chain: Another Puzzle by Gwyneth K. Shaw for the New Haven Independent (the graphic was originally published in the Journal of Agricultural and Food Chemistry),

“]

At left, a plant showing the selective uptake and translocation of nanoparticles; at right, a cross section of the root structure, showing how different substances react. [image originally published in Journal of Agricultural and Food Chemistry, downloaded from the New Haven Independent

Shaw’s article is about a study (Interaction of Nanoparticles with Edible Plants and Their Possible Implications in the Food Chain [this is behind a paywall]) by researchers at the University of Texas at El Paso, which reviews current studies in the field and suggests that as nanoparticles enter the food chain we need to consider cumulative effects.

Meanwhile, the discussion about developing regulatory frameworks and whether or not we need to have a definition for nanomaterials before setting a regulatory framework continues. From the June 7, 2011 news item on Nanowerk,

The Belgian Presidency of the Council of the European Union organized a high level event on September 14, 2010, bringing together representatives of various associations (consumers, environmental protection, workers, industrial federations), scientists, regulatory experts as well as national and European regulatory bodies, in order to review the legislative initiatives in progress with regard to nanomaterials and to establish an operational framework for the management of incidents in the short term and to achieve improved risk management in the long term.

Initially I confused this meeting with the March 2011 meeting mentioned in my April 14, 2011 posting but I gather there are a number of meetings (some of which seem remarkably similar) on the topic with various European Union groups and subgroups. The September 2010 meeting was under the auspices of the European Union and the March 2011 meeting was under the auspices of the European Commission (which I believe is part of the European Union bureaucracy). In any event, the September 2010 meeting resulted in a set of objectives being set (from the news item),

THE [European Union] PRESIDENCY CONCLUDES THAT, IN ORDER TO protect the workers, consumers health and the environment, and at the same time guarantee the development of a secure and sound economy based notably on innovation and societally acceptable industrial applications that create quality jobs, THE FOLLOWING OBJECTIVES MUST BE REACHED, IN RELATION TO NANOMATERIALS, PRODUCTS CONTAINING NANOMATERIALS AND NANOTECHNOLOGIES:

1) REGARDING THE REGULATORY FRAMEWORK:

  • to effectively address their potential risks and uncertainties, at the earliest, and thus ensure a high level of environment and health protection;
  • to consider their challenges transversally, across sectors, disciplines and regulations;
  • in parallel, to implement specific regulatory measures to deal with their particularities;
  • to appropriately inform and consult consumers, workers and citizens;

    2) REGARDING SCIENCE, RESEARCH, INNOVATION AND KNOWLEDGE:

  • to develop the necessary scientific knowledge in a global, coordinated and open manner;
  • to be proactive and to anticipate when dealing with the risks and uncertainties of new technological developments.

    IN CONSEQUENCE, THE FOLLOWING ACTIONS HAVE TO BE TAKEN:

  • to take up responsibilities at the Member States level and, during a transitory period, draw up coordinated and integrated national strategies and concrete measures in favour of risk management, information and monitoring;
  • to develop urgently a regulatory definition for nanomaterials that must include nanomaterials all along their lifecycle, including into substances, products, articles, wearing residues and waste; [emphasis mine]
  • to consider nanotechnology as a priority into a future 2nd Environment and Health Action Plan, including inter alia basic and applied research related to them, their specific potential risks, their traceability and the link between innovation, environment and health safety;
  • to clarify the various issues that remain presently unaddressed in the Commission proposals to adapt REACH to the nanomaterials and, in addition to the adaptations to the guidances to include significant modifications into the REACH 2012 review, including the lowering of the tonnage triggers for nanomaterials, modifications to data requirements in REACH annexes, consideration of nanomaterials as new substances, annexes V (exemptions) and XIII review (PBT, vPvB) and the inclusion in REACH of a definition of nanomaterials and articles containing nanomaterials;
  • to increase public and private resources, especially the financial inputs to the OECD WPMN, with the goal of obtaining results to be used for regulatory purposes as soon as possible;
  • to develop harmonized compulsory databases of nanomaterials and products containing nanomaterials;
  • such databases must be the base for traceability, market surveillance, gaining knowledge for better risk prevention and for the improvement of the legislative framework;
  • to take into account, in the design of such databases, the need for providing information to the citizens, workers and consumers regarding nanomaterials and products containing nanomaterials as well as the industry’s need for data protection;
  • claims made on labels of products containing nanomaterials must be regulated and the requirements to inform the consumer of the presence of nanomaterials in consumer products must be defined;
  • to consider sustainability, societal benefits, demands for public participation, and ethical considerations in the public investments in innovative technologies;
  • to establish a systematic, balanced and appropriate link between on the one hand the assessment of risk, early warnings and uncertainties and on the other hand the public investments in innovative technologies in general and nanotechnologies in particular, including financing mechanisms that take such a link into account;
  • to consider research in toxicology and ecotoxicology of nanomaterials, as well as their fate along the whole lifecycle as a high priority.

There is a school of thought that a regulatory framework can be put in place without establishing a definition beforehand as per my April 15, 2011 posting where I mentioned Dr. Andrew Maynard’s proposal and expressed some hesitation. I see Dexter Johnson (of the Nanoclast blog on the IEEE [Institute of Electrical and Electronics Engineers] website), after interviewing Rudolf Strohmeier, Deputy Director General, Directorate General for Research & Innovation for the European Commission at the EuroNano Forum 2011 in Budapest, Hungary, has weighed in with this in his May 31, 2011 posting,

Below is an audio recording I made of my exchange with Mr. Strohmeier. Interestingly, according to him, the definition was necessary for educating EU citizens as much as for developing regulations. …

In fairness, I didn’t really get a chance to follow up with Mr. Strohmeier to see if he could see the problems that arise when you arbitrarily arrive at a definition that may not always reflect the latest science on the topic. Nonetheless, I can’t help but think that a definition that is as much about mollifying the public as it is about good science has inherent risks itself. [emphases mine]

I take Dexter’s and Andrew’s point about the potential problems that creating a definition for what I’m going to call ‘public relations purposes’ could cause but I still haven’t grasped how one would create a regulatory framework without a definition of some kind (but maybe that’s just the writer in me).

All of this certainly puts the Canadian situation into perspective. There’s an interim definition in place. As for a regulatory framework, it appears that the government (Health Canada) favours a case by case approach as per their plans to investigate nanosunscreens (noted in my June 3, 2011 posting).