Tag Archives: US Environmental Protection Agency

US Environmental Protection Agency funding opportunities

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The US Environmental Protection Agency (EPA) has announced a couple of funding opportunities for some new centers. The first one I’m going to mention is the call for Centers for Material Life Cycle Safety. From the Jan. 3, 2012 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications for an interdisciplinary center focused on the application of a life cycle perspective towards the development of materials (Centers for Material Life Cycle Safety). Funding Opportunity Number: EPA-G2012-STAR-B1. Solicitation Closing Date: April 25, 2012, 11:59:59 pm Eastern Time. [emphasis mine]

Note: The term “materials” broadly refers to any and all types of chemicals, including individual chemicals, compounds, mixtures of compounds, or products. Such examples of materials include a discreet molecule, a polymer, a nanomaterial or a biochemical. [emphasis mine]

The aim of the center will be to develop methodologies and practices for materials design which applies a holistic perspective. This holistic approach to design, which considers all the stages of a material’s life cycle, provides an opportunity to produce materials which minimize, and preferably eliminate, any associated potential environmental and human health impacts that may occur during the life cycle.

You can read more about funding opportunity EPA-G2012-STAR-B1  here where, amongst other things, you’ll find out that requests for amounts exceeding $5M will not be considered. There’s a total of $10M to be awarded for the centers and the EPA anticipates awarding two grants.

The second funding opportunity announced by the US EPA is for  Centers for Sustainable Molecular Design. From the Jan. 3, 2012 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications for an interdisciplinary center focusing on the sustainable molecular design of chemicals (Centers for Sustainable Molecular Design). Funding Opportunity Number: EPA-G2012-STAR-C1. Solicitation Closing Date: April 25, 2012, 11:59:59 pm Eastern Time. [emphasis mine]

Note: The term “chemicals” broadly refers to any and all types of materials, including individual chemicals, compounds or mixtures of compounds, endocrine disrupting chemicals (EDCs), and nanomaterials. [emphasis mine]

The aim of the center will be to develop a set of parameters and strategies that will establish design criteria regarding the properties of chemicals that will lead to the development of intrinsically less hazardous substances when compared to those currently used in society. These newly acquired criteria and design principles will direct researchers towards the generation of novel chemicals that will minimize, and preferably eliminate, associated potential environmental and human health impacts that may occur during the life cycle of that chemical. The advent of these novel chemicals and their respective discovery of correlations between a chemical’s inherent properties and their adverse impacts require the development of improved methods for the design of next generation chemicals.

You can read more about funding opportunity EPA-G2012-STAR-C1 here. Just like the Centers for Material Life Cycle Safety awards, you’ll find that requests for Centers for Sustainable Molecular Design in amounts exceeding $5M will not be considered. There’s a total of $10M to be awarded for the centers and the EPA anticipates awarding two grants.

I find it quite interesting that the study of nanomaterial life cycles in various forms is being classified as a subset of a larger topic, e.g. Material Life Cycle Safety and Sustainable Molecular Design.

First lawsuit on risks of nanotechnology?

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I got this Dec. 21, 2011 news release this morning,
 

Consumer Safety Groups File First Lawsuit on Risks of Nanotechnology

San Francisco, CA – Concerned by the growing body of scientific reports cautioning against the unregulated use of nanotechnology in consumer products, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) today.  The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials.

Nanotechnology is a powerful platform technology for taking apart and reconstructing nature at the atomic and molecular level.  Just as the size and chemical characteristics of manufactured nanomaterials give them unique properties, those same properties – tiny size, vastly increased surface area to volume ratio, and high reactivity – can also create unique and unpredictable health and environmental risks.

The lawsuit demands FDA respond to a petition the public interest organizations filed with the agency in 2006, nearly six years ago.  The coalition is led by the International Center for Technology Assessment (CTA), on behalf of fellow plaintiffs Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy.

“Nano means more than tiny; it means materials that have the capacity to be fundamentally different.  Yet more and more novel nanomaterials are being sold infused into new consumer products every day, while FDA sits idly by,” said George Kimbrell, ICTA Attorney.  “The agency’s unlawful delay unnecessarily places consumers and the environment at risk.”

The eighty-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility.  The 2006 petition [http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf] requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency.

Nanomaterials in sunscreens, one of the largest sectors of the nano-consumer product market, were also a focus of the action.  The petitioners called on the agency to regulate nano-sunscreens to account for their novel ingredients rather than assume their safety, and to pull such sunscreens from the market until and unless the agency approves them as new drug products.

“Year after year goes by but we have yet to see the FDA do the bare minimum and require nanosunscreens to be labeled as such. This is a basic consumer right,” said Ian Illuminato of Friends of the Earth.  “We’re well past the 1800s — nobody likes or should be forced to use mystery chemicals anymore.”

Since 2006, numerous studies and reports, including agency publications by the Environmental Protection Agency, the Office of the Inspector General, and the U.S. Government Accountability Office, acknowledge significant data gaps concerning nanomaterials’ potential effects on human health and the environment.  Most troubling are studies using mice that show that nano-titanium dioxide when inhaled and when eaten can cause changes in DNA that affect the brain function and may cause tumors and developmental problems in offspring.  One study found titanium dioxide nanoparticles were found in the placenta, fetal liver and fetal brain.

“It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day,” said Wenonah Hauter, executive director of Food & Water Watch. “It is past time for this agency to live up to its mission and protect public health by assessing the health and environmental risks of nanomaterials, and to require labeling so that consumers know where these new materials are being used.”

“The scientific consensus is that nanomaterials require specific testing to account for their novel capacities and potential risks.  The FDA must do such testing as part of a pre-market safety assessment in a broader regulatory initiative to protect public health,” said Steve Suppan of the Institute for Agriculture and Trade Policy.

For more, see generally (http://www.icta.org/about/).

Despite the headline ICTA gave this news release, I found a 2008 news release for another nanotechnology law suit where they were suing the US Environmental Protection Agency,  GROUPS DEMAND EPA STOP SALE OF 200+ POTENTIALLY DANGEROUS NANO-SILVER PRODUCTS; Nanotech Watchdog Launches First-Ever Legal Challenge To EPA Over Unregulated Nanotech Pesticide Pollution.

If I understand this rightly, the ICTA along with its coalition partners is suing the FDA for not responding to its petition, which would have made for a much less compelling headline. I didn’t have much luck accessing the 2006 petition (clicking on the link brought up an error page) but will try again later.

I notice that sunscreens with with nanoscale titanium dioxide are used as an example of the use of dangerous nanomaterials in consumer products. It seems the general consensus is that nanoscale titanium dioxide and/or zinc oxide used in nanosunscreens are relatively safe. You can read more about this on the Cancer Council of Australia or the Environmental Working Group (EWG) websites. From the EWG,

EWG reviewed the scientific literature on hazards and efficacy (UVB and UVA protection) for all active ingredients approved in the U.S. Though no ingredient is without hazard or perfectly effective, on balance our ratings tend to favor mineral sunscreens because of their low capacity to penetrate the skin and the superior UVA protection they offer.

I really wish they would stop using the nanosunscreens as their ‘go to’ concern as I think it damages these groups’ credibility.

Still, the FDA should respond to a petition and six years seems like a long time to wait.

Nano regulatory frameworks are everywhere!

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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.

Green-nano zero valent iron (G-nZVI)

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I’m quite interested in patents and their possible impact on nanotechnology innovation so this item caught my attention. VeruTEK Technologies, Inc. just received notice of a patent allowance for the Green-nano zero valent iron (G-nZVI) product which was developed in collaboration with the US Environmental Protection Agency (EPA).

From the June 15, 2011 news item on Nanowerk,

The product is ideal for a broad range of remediation applications including treating produced water (wastewater) generated during oil and gas and other chemical production processes.

G-nZVI works more efficiently than conventional iron catalysts, significantly increasing the rate of oxidant activity and can be used under a wide range of conditions.  Unlike other catalysts which are typically sensitive to changes in pH, G-nZVI consistently delivers high performance over a wide pH range. G-nZVI is highly effective as an activator for VeruTEK’s patent-pending Surfactant-enhanced In Situ Chemical Oxidation (S-ISCO®) treatment of hydrocarbon and chlorinated solvent contamination. The product can also be used with conventional in situ chemical oxidation (ISCO) to improve the effectiveness of traditional remediation chemistry.

The EPA works with VeruTEK on a variety of projects, concentrating on new field-proven approaches to address difficult environmental issues. According to John Leazer, Director of the Sustainable Technology Division at EPA’s National Risk Management Research Laboratory in Cincinnati, “Patent awards are superb examples of what can be accomplished through collaborative research and development.” [emphases mine]

I have previously written about nano zero valent iron (nZVI) and site remediation in my March 30, 2011 posting which concerned a benchmarking study for nZVI and briefly in my March 4, 2010 posting (towards the end) where I summarized a Project on Emerging Nanotechnologies webcast (approximately 54 min.) on the topic.

As I understand it, the process (green or environmentally friendly) by which the nano zero valent iron is derived is the reason the VeruTek product has been awarded a patent and not because its remediation capabilities are superior to other nano zero valent iron products. From the VeruTEK’s G-nZVI product page,

GnZVI is a green synthesized nanoscale zero valent iron catalyst invented by VeruTEK and the US EPA. During the green synthesis process iron salts are exposed to naturally reductive plant material, the resultant nanoscale particles are coated in iron oxide and plant polyphenols which confer advantageous properties.  Research conducted by VeruTEK, the EPA and the University of Connecticut, published in peer reviewed journals, demonstrate the efficacy of the product and its unique chemical design.

So, in addition to being used to remove contamination, this product itself is manufactured in a relatively environmentally friendly fashion. Nice!

Of course, there’s a fair amount of discussion about how patenting impedes innovation. From Mike Masnick’s Feb. 17, 2011 article on Techdirt,

As with any “hot” technology area, it doesn’t take long for a massive, innovation hindering patent thicket to spring up. It effectively makes it impossible to bring anything to market unless you’ve got a huge patent portfolio yourself and deep pockets. Yet another example of patents harming the smaller players in the market. A new report is suggesting that the latest “hot” area to get patent crazy is nanotechnology.

However, the really worrying thing about the report is that it notes that the single largest “patent patron” in nanotechnology… is the federal government. [emphasis mine]

The report, The Big Downturn; Nanogeopolitics, that Masnick is referring to is from The ETC Group who released it on Dec. 17, 2010 so the material in it is relatively recent. They provide the only overview of the nanotechnology patent scene (Chapter 12, p. 43 PDF version and p. 36 print version) that I’ve come across so far. I find the reference to the federal government (US in this case) as being the largest patent patron interesting in light of the EPA’s collaborative relationship with VeruTEK.

One comment before you rush off to read The ETC Group’s report, the tone is very much ‘we are on the side of the angels; capitalists and governments and ‘anyone who disagrees with us in any way’ are not.”

RTI and nanotechnology regulation

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This is a classic public relations ploy: RTI is hosting a workshop of experts to discuss nanotechnology regulation at the National Press Club in Washington, DC on May 4, 2011. From the April 28, 2011 news item on Nanowerk,

Leading experts will gather at the National Press Club in Washington, D.C., May 4 to discuss the challenges of regulating nanotechnologies.

The policy forum, titled Nanotechnology: the Huge Challenge of Regulating Tiny Technologies, will bring together thought leaders who represent public, private and academic communities to discuss the issues, concerns and public policies needed to maximize the benefits of this emerging technology while minimizing the risks and encouraging further development and scientific exploration.

The event, held from 9 to 10:30 a.m., is being hosted by RTI International. Speakers include Michele Ostraat, Ph.D. senior director of the Center for Aerosol and Nanomaterials Engineering at RTI; Sally Tinkle, Ph.D., deputy director, National Nanotechnology Coordination Office; Jim Alwood, Toxic Substances Control Act Nanotechnology Coordinator at the U.S. Environmental Protection Agency; and Cole Matson, Ph.D., executive director at the Center for the Environmental Implications of Nanotechnology at Duke University.

RTI (trade name for Research Triangle Institute) is not a speaker’s agency as you might have thought after reading this item. From RTI’s About page,

RTI International is one of the world’s leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our staff of more than 2,800 provides research and technical services to governments and businesses in more than 40 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy and the environment, and laboratory testing and chemical analysis.

This is really quite well done. It’s being held at an impressive venue, the National Press Club, which associates this event with journalism in a subtle way. Three of the speakers are impressive due to their reputations and association with the National Nanotechnology Coordination Office, the Environmental Protection Agency, and Duke University, respectively. Additionally, someone from RTI is moderating the event and one of their senior directors is a speaker so the event is wrapped within the RTI brand. On a personal note, my hat’s off to whoever organized this panel for managing to get gender parity. That can be tough to achieve when it’s a science-related topic.

If you’re curious about the event you can read more about it here at RTI’s website.

New interdisciplinary programmes on nanotechnology environmental impacts and policy; new NSF graduate environmental studies funding category: nanotechnology

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Coincidentally or not I’ve come across two items today about environmental studies and nanotechnology. The first concerns a new interdisciplinary programme in the environmental effects and policy implications of nanotechnology being offered jointly by Carnegie Mellon University and Howard University. From the news item on Nanowerk,

Researchers at Carnegie Mellon University and Howard University in Washington, D.C. have received $3.15 million over the next five years from the National Science Foundation (NSF) to launch a new interdisciplinary program in the environmental effects and policy implications of nanotechnology.

Funding comes from a new NSF program called the Integrative Graduate Education and Research Traineeship (IGERT), which enables creation of interdisciplinary programs educating U.S. Ph.D. scientists and engineers.

“The IGERT program at Carnegie Mellon and Howard will operate at the interface of science and environmental policy to produce an environmentally and policy literate generation of nanoscience professionals with the skills needed to create novel nanotechnologies and to assess and manage environmental risks associated with nanomaterials,” said Jeanne M. VanBriesen, professor of civil and environmental engineering at Carnegie Mellon who will lead the program.

Graduate students from multiple disciplines will participate in a two-year-training program to learn the fundamentals of their core disciplines and gain proficiency in the analysis of environmental issues pertaining to nanotechnology, decision science, and policy-analysis in new nanotechnology-themed courses. Following this foundation, students will conduct research at the interface of policy and nanotechnology. Students also will participate in international laboratory exchange projects as well as internships at corporations active in nanotechnology.

I guess this is a consequence of the recent National Nanotechnology Initiative budget which dedicated more money to environmental research. In another development, the US Environmental Protection Agency (EPA) is offering fellowships for students pursuing graduate environmental study including those who want to focus on nanotechnology. From the news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA), National Center for Environmental Research (NCER), invites applications for the Science to Achieve Results (STAR) Fellowships for graduate environmental study for master’s and doctoral level students.

The deadline is November 5, 2010 at 4:00 PM for receipt of paper applications, and November 5, 2010 at 11:59:59 PM ET for submittal of electronic applications via Grants.gov.

…

This solicitation contains several important changes from the previous solicitation. First, Social Sciences and Tribes and American Indian/Alaska Native/Pacific Islander Communitieshave been added as topic areas in response to the EPA Administrator’s priorities. Secondly, Nanotechnology has been added in response to the Assistant Administrator’s articulated vision for the Office of Research and Development.

The relevant Funding Opportunity Numbers (FON) for the nanotechnology topic is EPA-F2011-STAR-C1.

You can get more information directly from the EPA here.

German report on nanosilver toxicity and some thoughts on the US EPA silver nanomaterials consultation

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More about nanosilver toxicology (see earlier posting about US EPA silver nanomaterials consultation) this week courtesy of an article by Michael Berger about a new report from a group of German researchers. From the article on Nanowerk,

Silver had already been recognized in ancient Greece and Rome for its infection-fighting properties but in modern times pharmaceutical companies made more money developing antibiotics. However, thanks to emerging nanotechnology applications, silver has made a comeback in the form of antimicrobial nanoparticle coatings for textiles, surgical instruments, lab equipment, floors or wall paints (see for instance: “Antibacterial nanotechnology multi-action materials that work day and night”).

The flip side of silver’s desired toxicity towards microbes is that it might have toxic effects for humans as well (“As nanotechnology goes mainstream, ‘toxic socks’ raise concerns”) and this has raised debate about the safety of nanosilver products. Although scientists have worked to reduce the toxicity of antimicrobial nanosilver in products, concerns remain.

Not helping to put these concerns to rest is a new report from a group of researchers in Germany that shows that toxicity of silver nanoparticles increases during storage because of slow dissolution under release of silver ions.

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According to Epple [Matthias Epple, a professor for inorganic chemistry at the University of Duisburg-Essen], there is a general agreement that dissolved silver ions are responsible for the biological action that is especially pronounced against microorganisms. The lethal silver concentration of silver nanoparticles for human mesenchymal stem cells is about three times higher than that of silver ions (in terms of the absolute concentration of silver in a given solution).

The report has been published by the American Chemical Society in Chemistry of Materials. You can find an abstrect here, the full article is behind a paywall.

I was interested to note that the focus for the report is on the dissolution of nanoscale silver in water. By contrast, the US EPA consultation uses, as its starting point for the case study, nanoscale silver in an antibacterial spray. While laboratory researchers tend to focus on specifics such as the dissolution of  silver nanoparticles and ions, the EPA’s strategy allows for a 360o view. Theoretically, commenters could focus on anything from the production of the air spray, its own packaging, its use in various situations such as hospitals or food packaging, etc., and the various ways it dissipates into the environment, e.g. being washed off and ending up in the water supply.  This can lead to a comprehensive framework for future research activities examining more specific questions which provide answers that fit back into the framework.

Berger’s article reminds me of an October 29, 2009 news item on Science Daily about Swiss researchers, clothes washers, and nanosilver,

Scientists in Switzerland are reporting results of one of the first studies on the release of silver nanoparticles from laundering those anti-odor, anti-bacterial socks now on the market. Their findings may suggest ways that manufacturers and consumers can minimize the release of these particles to the environment, where they could harm fish and other wildlife.

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They found that most of the released particles were relatively large and that most came out of the fabrics during the first wash. The total released varied from 1.3 to 35 percent of the total nanosilver in the fabric. Bleach generally did not affect the amount released. “These results have important implications for the risk assessment of silver textiles and also for environmental fate studies of nanosilver, because they show that under certain conditions relevant to washing, primarily coarse silver-containing particles are released,” the paper says.

The research report was published by the American Chemical Society’s Environmental Science and Technology journal. The abstract is available here, the full article is behind a paywall.

US Government Accountability Office chimes in on the nanomaterials regulatory debate

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

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

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

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

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

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

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

Global TV (national edition) and nanotechnology; EPA develops a ‘kinder to animals’ nanomaterials research strategy

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Wouldn’t you know it? Just as soon as I finish my ‘science communication in Canada’ series, Global TV’s national news starts broadcasting a series on nanotechnology. Interestingly, the focus in part 1 is on medicine only. There was no mention of any other kind of application or the fact that we already have many nanotechnology-based products available in consumer markets. Maybe they’ll mention these other sectors in subsequent parts of the series.

They too (it was one of the problems I mentioned at my recent conference talk at ISEA 2009) were stuck for ways of communicating nanotechnology and so reverted to the human hair example (i.e. a nanometer = 1/100,000 of a human hair). I f you want to see part 1 of the series, it’s here.  Oh, they have beautiful graphics.

The US Environmental Protection Agency (EPA) recently announced a nanomaterials research strategy which I mentioned here in my Oct. 1, 2009 posting and they’ve already revised it. This time it’s all about the animals. According to the news item on Azonano,

Importantly, the research strategy articulates the goal of identifying non-animal methods that may ultimately be able to preclude the perceived need for any in vivo testing. The EPA appears to have taken to heart the principles outlined in the National Academy of Sciences’ report ‘Toxicity Testing in the 21st Century: A Vision and a Strategy,’ which calls for increased use of current non-animal technologies and biological understanding that is more precise, relevant, and that will improve hazard assessment.

There’s more at Azonano. I’m glad to see that the effort to move away from animal testing is being embraced.