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UNIDYM ANNOUNCES ALLIANCE WITH SAMSUNG ELECTRONICS

Sunnyvale, CA - December 8, 2010 - Unidym, Inc., a majority owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), announced today that it has completed IP cooperation and license agreements with Samsung Electronics Co., Ltd. ("Samsung"). Under the agreements:

1. Unidym licensed to Samsung patents covering CNT materials, including fundamental patents on CNT compositions of matter, synthesis of CNTs, processing of CNTs, ink formulations, and transparent conductive films.

2. Unidym transferred certain patent rights to Samsung, primarily related to electronic devices incorporating CNTs. Samsung granted back to Unidym licenses to sell products under the transferred patent rights.

3. Unidym and Samsung will continue to work together to develop and commercialize CNT-based products.

"This is an important development in carbon-based electronics," said Mark Tilley, President and CEO of Unidym. "We have worked with Samsung Electronics for several years, and we are now looking forward to this next phase in our relationship. We expect Samsung's investment in this alliance and ongoing IP cooperation with Unidym will open the market for printable carbon electronics."

About Samsung Electronics Co., Ltd.

Samsung Electronics Co., Ltd. is a global leader in semiconductor, telecommunication, digital media and digital convergence technologies with 2009 consolidated sales of US$116.8 billion. Employing approximately 174,000 people in 193 offices across 66 countries, the company consists of eight independently operated business units: Visual Display, Mobile Communications, Telecommunication Systems, Digital Appliances, IT Solutions, Digital Imaging, Semiconductor and LCD. Recognized as one of the fastest growing global brands, Samsung Electronics is a leading producer of digital TVs, memory chips, mobile phones and TFT-LCDs. For more information, please visit www.samsung.com <http://www.samsung.com> .

About Unidym, Inc.

Unidym is a leader in carbon nanotube-based transparent, conductive films (TCFs) for the electronics industry. TCFs are a critical component in devices such as touch panels, displays, and thin-film solar cells. For example, both touch panels and LCDs typically employ two TCF layers per device. Unidym's TCFs offer substantial advantages over the incumbent technology, indium-based metal oxides, including: improved durability, lower processing costs, and lower overall cost structure. For more information, visit: http://www.unidym.com <http://www.unidym.com> .
 

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This article originally appeared on the National Nanomanufacturing Network's InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Over the past few years, USEPA's California office has levied fines against manufacturers of products incorporating nanoscale materials when the companies have made unsubstantiated claims that their products kill germs, mold, bacteria, and other household pathogens. For example, in 2008, USEPA fined a California computer peripherial manufacturer -- IOGEAR -- $208,000 for selling a wireless mouse and a wireless mouse/keyboard combination while making claims that the products' nanosilver coatings killed germs and pathogens. In 2009, USEPA levied a similar fine against a company using silver-ion technology in shoe inserts to kill odor causing bacteria.

In this latest round, USEPA has now levied a $82,400 fine against California-based Kinetic Solutions stemming from the company's anti-microbial claims related to an air-purifier that utilized a "nano-silver pre-filter." According to the company's promotional material, its "RabbitAir" purifiers use HEPA filters to "filter out 99.97% of the allergens and pollutants from the air you breathe without producing more harmful byproducts in the process." The company's website, however, no longer contains any information about its "nano-silver pre-filters," or any antimicrobial claims.

The fine against Kinetic Solutions is for alleged violations of the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA) – a somewhat obscure federal statute that many manufacturers would be amazed to learn applies to their "non-insecticide" products. After all, since when is an air-purifier considered an insecticide? The short answer is "as soon as the manufacturer starts making claims that it kills germs." Once such claims are made, the product must be registered with USEPA as a pesticide and the claims must be substantiated by valid scientific studies. Additionally, the manufacturer must register its plant as a pesticide manufacturing facility and label its products with a registration number designated by USEPA.

In a press-release about the fine, USEPA indicated that: "[m]ore and more manufacturers are touting 'nano' particles as antimicrobial. EPA takes unsubstantiated claims very seriously, and as with the case against Kinetic Solutions, we will take action against unregistered products." Additonally, USEPA indicated that it "will not register a pesticide until it has been tested to show that it will not pose an unreasonable risk when used according to the directions. Consumers should be careful to look for the EPA registration number printed on product labels, and to follow the directions for safe use."

Thus, while it was Kinetic Solution's antimicrobial claims that brought about its unfortunate legal problems – rather than the use of nanosilver itself – companies should still cautiously check to make sure they have a good understanding of any potentially applicable state and federal laws before they begin selling a new innovative product.

Sources:

Hefty fine for So Cal Company's untested "nano" claims, USEPA, http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a9efb85257359003fb69d/3db62e7e695b684a852577fa005948dc!OpenDocument.

Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C.A. § 136(e)(a) (2008).

FIFRA and Fines, Nanotechnology Law Report, http://www.nanolawreport.com/2008/03/articles/fifra-and-fines/.

EPA Takes Aim at Anitmicrobial Products Under FIFRA, Nanotechnology Law Report, http://www.nanolawreport.com/2009/09/articles/epa-takes-aim-at-anitmicrobial-products-under-fifra/.

RabbitAir, http://www.rabbitair.com/.
 

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This article originally appeared on the National Nanomanufacturing Network's InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On December 6, 2010, the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council's Committee on Technology released the draft "National Nanotechnology Initiative 2011 Environmental, Health, and Safety Strategy" (2011 NNI EHS Research Strategy). The document is intended to replace the National Nanotechnology Initiative's (NNI) prior 2008 document covering the same topics, and "aims to ensure the responsible development of nanotechnology by providing guidance to the Federal agencies that produce and use scientific information for risk assessment and risk management." The document identifies five primary EHS research areas of interest to NNI: nanomaterial measurement, human exposure assessment, human health, environment, and risk assessment/management. NNI notes that information derived from research in these five areas will be "applied to product life cycle, regulatory decision making, public outreach, and research planning."

Comments on the 2011 NNI EHS Research Strategy can be submitted through Jan. 6, 2011 by using the NNI's Strategy Portal at http://strategy.nano.gov/blog/generic/page/draft-nni-ehs-strategy.

Background

The 2011 NNI EHS Research Strategy was created by soliciting input from the various federal agencies involved with NNI, academia, industry, advocacy groups, and the general public. Input "included four public workshops, [and] reviews by the National Academies…and the President’s Council of Advisors on Science and Technology." The report itself was drafted by a team of "over 70 members from 12 NNI agencies," and contains a chapter on each of the above-identified research areas. The report also contains a chapter regarding the organization and dissemination of existing EHS information, and a closing chapter making recommendations for the timely and effective implementation of the 2011 NNI EHS Research Strategy's goals. Each chapter is briefly covered below.

Nanomaterial Measurement Infrastructure

The Nanomaterial Measurement Infrastructure chapter of the 2011 NNI EHS Research Strategy identifies five primary research needs, each with subcomponents: develop measurement tools for (i) determination of physico-chemical properties of engineered nanomaterials (ENMs) and nanotechnology-enabled products (NEPs); (ii) detection and monitoring of ENMs in realistic exposure conditions; (iii) evaluation of transformations of ENMs in relevant media; (iv) evaluation of biological responses to ENMs and NEPs; and (iv) evaluation of release mechanisms of ENMs from NEPs.

Forty two research projects at the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), National Institute for Occupational Safety and Health (NIOSH), National Institute of Standards and Technology (NIST), and National Science Foundation (NSF) costing $ 11,081,000 are currently being undertaken to achieve these needs.

Human Exposure Assessment

The Human Exposure Assessment chapter of the 2011 NNI EHS Research Strategy identifies four primary research needs, each with subcomponents: understand processes and factors that determine exposures to nanomaterials; identify population groups exposed to engineered nanomaterials; characterize individual exposures to nanomaterials; and conduct health surveillance of exposed populations.

Fourteen research projects at Consumer Product Safety Commission (CPSC), EPA, NIOSH and NSF costing $ 3,289,000 are currently being undertaken to achieve these needs.

Human Health

The Human Health chapter of the 2011 NNI EHS Research Strategy identifies six primary research needs, each with subcomponents: identify or develop appropriate, reliable, and reproducible in vitro and in vivo assays and models to predict in vivo human responses to ENMs; quantify and characterize ENMs in exposure matrices and biological matrices; understand the relationship between the physico-chemical properties of ENMs and their transport, distribution, metabolism, excretion, and body burden in the human body; understand the relationship between the physico-chemical properties of ENMs and uptake through the human port-of-entry tissues; determine the modes of action underlying the human biological response to ENMs at the molecular, cellular, tissue, organ, and whole-body levels; determine the extent to which life stage and/or susceptibility factors modulate health effects associated with exposure to ENMs and nanotechnology-enabled products and applications.

One hundred fifteen research projects at Department of Defense (DoD), CPSC, EPA, FDA, National Institutes of Health (NIH), NIOSH, NIST, and NSF costing $ 41,610,000 are currently being undertaken to achieve these needs.

Environment

The Environment chapter of the 2011 NNI EHS Research Strategy identifies five primary research needs, each with subcomponents: understand environmental exposures through identification of principal sources of exposure and exposure routes; determine factors affecting the environmental transport of nanomaterials; understand the transformation of nanomaterials under different environmental conditions; understand the effects of engineered nanomaterials on individuals of a species and the applicability of testing schemes to measure effects; and evaluate the effects of engineered nanomaterials at the population, community, and ecosystem levels.

Twenty-seven research projects at EPA, NSF, DoD/United States Air Force, National Institute of Food and Agriculture, Department of Energy, and NIST costing $ 43,682,000 are currently being undertaken to achieve these needs.

Risk Assessment and Risk Management Methods

The Risk Assessment and Risk Management Methods chapter of the 2011 NNI EHS Research Strategy identifies five primary research needs, each with subcomponents: incorporate relevant risk characterization information, hazard identification, exposure science, and risk modeling and methods into the development and evaluation of nanomaterials; understand, characterize, and control workplace exposures to nanomaterials; integrate life cycle considerations into risk assessment and risk management; integrate risk assessment into decision-making frameworks for risk management; and integrate and standardize risk communication within the risk management framework.

Forty-two research projects at EPA, FDA, NIOSH, and NSF costing $7,068,000 are currently being undertaken to achieve these needs.

Informatics and Modeling for NanoEHS Research

Regarding Informatics and Modeling for NanoEHS Research, the 2011 NNI EHS Research Strategy makes three primary recommendations: improve quality and availability of data; expand theory, modeling; and simulation capabilities, and "[d]evelop computational models of [engineering nanomaterial] structure–property–activity relationships to support the design and development of [engineering nanomaterials] with maximum benefit and minimum risk to humans and the environment."

The Path Forward

Regarding "The Path Forward," the 2011 NNI EHS Research Strategy makes several recommendations, including prioritizing engineered nanoscale materials for EHS research; establishing "standard measurements, terminology, and nomenclature;" maximizing data quality; stratifying knowledge for risk assessment; and leveraging public-private partnerships.
Finally, the document closes with several recommendations for speeding the implementation of the 2010 NNI EHS Strategy: increasing agency participation in NNI EHS research, naming an NNCO EHS coordinator, "exploiting media and networking opportunities," enabling "a broad base of nanoEHS research to support regulatory decision making," facilitating public-private partnerships, coordinating international nano-related EHS research activities, and adoptively managing and adapting the NNI Research Strategy as research progresses.
 

Sources:

National Nanotechnology Initiative, 2011 Environmental, Health, and Safety Strategy, available at http://strategy.nano.gov/wp/wp-content/uploads/2010/12/Draft-2011-NNI-EHS-Research-Strategy.pdf (last visited Dec. 9, 2010).

National Nanotechnology Initiative, Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (2008), available at http://www.nano.gov/NNI_EHS_Research_Strategy.pdf (last visited Dec. 10, 2010).
 

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This article originally appeared on the National Nanomanufacturing Network's InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

In late November, the National Institute for Occupational Safety and Health (NIOSH) published a Current Intelligence Bulletin entitled "Occupational Exposure to Carbon Nanotubes and Nanofibers." The document is not an official "agency determination or policy," and was released solely by NIOSH for peer-review and comment. NIOSH's carbon nanotube recommended exposure limit (CNT REL) is set at 7 μg/m 3 for these preliminary purposes.

The old saying that "a picture is worth a thousand words" is once again proved by the document's cover image which is a remarkable "field emission micrograph of a multi-walled carbon nanotube…penetrating the pleura of the lung." The finely detailed image of a CNT penetrating a lung membrane should cause any reader to stop and closely consider the document's recommendations.

The document begins by noting that while there are no scientific reports of "adverse health effects in workers producing or using carbon nanotubes…or carbon nanofibers," NIOSH is concerned because some studies have shown that the potential for worker exposure exists. Additionally, some in vivo studies have shown adverse reactions to carbon nanotubes in rodents -- including pulmonary inflammation and fibrosis. Further, some in vitro and in vivo studies have led researchers to theorize that inhalation of certain carbon nanotubes in large doses may potentially cause asbestos-type exposure effects.

NIOSH explains that the scientific basis for its CNT REL is an extrapolation from subchronic in vivo toxicity studies in rodents. "The REL is based on the available subchronic and short-term animal dose-response data of early-stage fibrotic and inflammatory lung response to CNT exposure. Benchmark dose (BMD) estimates from the animal data (and the 95% lower confidence limit estimates of the BMD) have been extrapolated to humans by accounting for species differences in alveolar lung surface area. Working lifetime exposure concentration have been calculated based on estimates of either the deposited or retained alveolar lung dose of CNT assuming an 8-hour time-weighted average (TWA) work shift exposure during a 40-hour work week, 50 weeks per year, for 45 years."

However, because a risk of adverse lung effects may occur even below the 7 μg/m 3 CNT REL, NIOSH further recommends reducing airborne levels of nanoscale carbon to as low as possible. Additionally, NIOSH recognizes that the REL is based on a mass dose metric which might not be appropriate for nanoscale materials because "a mass-based sampling method may not be sufficiently sensitive to detect all [carbon nanotubes] and [carbon nanofiber] structures in the air at low mass concentrations." Accordingly, NIOSH recommends additional research to determine the most appropriate dose metric.

The CNT REL is not provided in isolation, NIOSH also recommends that employers and workers follow the detailed workplace safety measures outlined in its comprehensive guidance document, "Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials." To this end, NIOSH provides summary information outlining the basic measures explained in its "Approaches" document.

Another notable feature of the document is its position regarding worker medical screening and surveillance. NIOSH concludes "that workers occupationally exposed to [carbon nanotubes] and [carbon nanofiber] may be at risk of adverse respiratory effects. These workers may benefit from inclusion in a medical screening program recommended as a prudent means to help protect their health." This last quasi-recommendation alters NIOSH's prior position that "[t]he current body of evidence about the possible health risks of occupational exposure to engineered nanoparticles is quite small. Insufficient scientific and medical evidence now exists to recommend the specific medical screening of workers potentially exposed to engineered nanoparticles."

The document closes by listing 15 scientific research needs to "assist NIOSH in evaluating the occupational safety and health concerns of working with [carbon nanotubes] and [carbon nanofiber]."

Finally, for those keeping track, in 2005, NIOSH proposed a REL for ultrafine TiO2 (essentially nanoscale TiO2) of .1 μg/m 3. Bayer Material Sciences previously set a worker exposure limit for its multi-walled carbon nanotube products (BayTubes) at .05 mg/m 3 in 2009. Similarly, NIOSH's REL for carbon black is 3.5 mg/m 3, and OSHA's permissible exposure limit for respirable synthetic graphite is 5 mg/m 3.

Sources:

National Institute for Occupational Safety and Health, Current Intelligence Bulletin, "Occupational Exposure to Carbon Nanotubes and Nanofibers," p. 3, available at http://www.cdc.gov/niosh/docket/review/docket161A/pdfs/carbonNanotubeCIB_PublicReviewOfDraft.pdf (last visited Dec. 9, 2010).

National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials (2009) available at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf.
 

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UPDATE

The House agreed to the Senate amendment to HR 5116 on 12/21/2010. We'll discuss the implications of this in more detail after the Xmas holiday.

The Senate unanimously passed H.R. 5116 on Friday 12/17/2010, after first adopting an amendment in the nature of a substitute. As opposed to the version of H.R. 5116 that was passed in the House, the language of the amended version contains no provisions to reauthorize the National Nanotechnology Initiative (NNI). As amended and passed by the Senate, the language of H.R. 5116 contains no references to nanotechnology at all.

The amended bill, basically a reduced version of S. 3605 as reported out of committee on 12/10/2010, reduces the amounts appropriated for various agencies such as the National Science Foundation and the National Institute of Standards and Technology, from $84 billion to $43 billion over a three year period.

Having been passed by the Senate in an amended version, H.R. 5116 must now go back to the House for another vote to accept the Senate's amendment. If this happens, then the bill will go to President Obama to be signed into law. However, if the House disagrees with the amendment, the bill would be sent to a Conference Committee, composed of Senators and Representatives appointed by Senate Majority Leader Harry Reid and Speaker of the House Nancy Pelosi, charged with the task of creating a comprise version that would be acceptable to both the House and Senate. It is possible that an amendment reauthorizing NNI could be adopted during House debate or in a Conference Committee; however, considering that the House is approaching adjournment, and that Rep. Bart Gordon, chairman of the House Science and Technology Committee and author of the House version of H.R. 5116,  has endorsed the bill, stating that "It keeps our basic research agencies on a doubling path, it continues to invest in high-risk, high-reward energy technology development, it will help improve STEM education, and it will help unleash American innovation", it is likely that the House will vote to agree to the Senate's amendment.

Rep. Ralph Hall, currently the Ranking Member of the Committee, stated that ". . . the bill that passed today spends too much money, authorizes duplicative programs, and shifts focus away from the bill's original intent." Rep. Hall will be Chairman of the House Science and Technology Committee in the 112th Congress.

Not having been reauthorized in this bill, the future of NNI is unclear.

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Harry Potter sat quietly at his desk, trying once more to make his way through "The History of Magic" that  Professor Binns had assigned, when Ron Weasley came into his room, excited and out of breath, holding the current issue of The Daily Prophet.

"Harry, have you seen  this?"

"Seen what", asked Harry, trying to sound slightly annoyed, but welcoming the distraction. How could a history of magic be so dull?, he thought.

"Does the EU have a Ministry of Magic?"

"Not that I've heard of. Why?"

Ron placed the newspaper before Harry, folded to an inner page. "Then there must be a wizard working for them."

Harry looked at his friend, then at the article

                                    E.U. CREATES INVISIBILITY CLOAK

"Nellie Kroes, the VP of the European Commission for the Digital Agenda, announced that  EU funded nanotechnology research had created an "invisibilty cloak", made up of nanometre sized rods that can bend light waves, changing the waves direction and speed around objects, effectively rendering them invisible.

The EC forsees applying the results of this research to the development of new and better lenses, light storage devices and other optical devices."

Harry looked up from the paper, then at his friend. A deep sigh escaped his lips.

"Invisibility." He shook his head slowly. "The next thing you know, the EU will have quidditch leagues."

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