Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

The NanoRelease Project is intended to support the development of methods to understand the release of nanomaterials used in products. To do this, the Project will: (1) examine full life cycles of nanomaterials in products; (2) work through specific release scenarios at key exposure points of the life cycle; (3) organize existing material characteristics data and measurement methods for those release scenarios; (4) develop a “state of the science” report for release measurement; and (5) carry out inter-laboratory testing to promote improvements, standardization, and widespread use of methods. The NanoRelease Project completed Phase 1 in 2011, resulting in the selection of multi-walled carbon nanotubes (MWCNT) in polymers as the first material to be evaluated through inter-laboratory studies of methods. In Phase 2, three Task Groups of more than 40 experts are evaluating: (1) measurement methods; (2) the effect of materials selected on release rates; and (3) identifying the key exposure/release scenarios. Each Task Group will produce a white paper on their respective topic. Phase 3 is scheduled to begin in late 2012, with a “round robin” approach to inter-laboratory testing using a reference nanomaterial-matrix and positive controls for the study of MWCNT released from selected polymers. The NanoRelease Project is organized by Dr. Richard Canady of the ILSI Research Foundation, and is supported by the U.S. Environmental Protection Agency, Environment Canada, Health Canada, the American Chemistry Council, the Society of Chemical Manufacturers & Affiliates, the National Institute of Standards and Technology, the Adhesive and Sealant Council, and the American Cleaning Institute.

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The NanoBusiness Commercialization Association, North Carolina Department of Commerce, and Center of Innovation for Nanobiotechnology will co-host the Nanotech Commercialization Conference on April 4-5, 2012, in Research Triangle, North Carolina. Lynn L. Bergeson will speak at the Conference, which will include:

• National-level keynote speakers;
• Sessions, workshops, and exhibits showcasing the latest advances in the field;
• Discussions on financing, licensing, and business development geared toward the nanotech entrepreneur;
• Sessions and exhibits showcasing cutting-edge research, products, and technologies; and
• Networking opportunities with connected professionals.

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On December 20, 2011, the National Institute of Standards and Technology (NIST) announced it issued the world’s first reference material for single-wall carbon nanotube soot.  According to NIST, “nanotube-laden soot is the primary industrial source of single-wall carbon nanotubes, perhaps the archetype of all nanoscale materials.” NIST states that the new material “offers companies and researchers a badly needed source of uniform and well-characterized carbon nanotube soot for material comparisons, as well as chemical and toxicity analysis.” NIST certifies each unit of SRM 2483 for the mass fraction values of several common contaminants, including barium, cerium, chlorine, cobalt, dysprosium, europium, gadolinium, lanthanum, molybdenum, and  samarium.  NIST provides reference values (values believed to be accurate, but not rising to the level of confidence that NIST certifies) for an additional seven elements. NIST has also posted a material safety data sheet (MSDS) for the reference material.

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On December 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) posted an item on its Science Blog entitled “Respiratory Protection for Workers Handling Engineered Nanoparticles.” The purpose of the blog item is to provide an update on the science and rationale behind NIOSH’s recommendations for the use and selection of respirators against engineered nanoparticles. The article summarizes respirator performance research and respirator selection. Concerning next steps, NIOSH states that, while its research to date has been done in laboratory settings, using filtration test systems and manikins under aggressive test conditions, further research is needed in field settings and using human test subjects.  According to NIOSH, “[w]ell-designed studies on face seal leakage of nanoparticles, especially workplace protection factor (WPF) studies that validate assigned protection factor (APF) levels for respirators against nanoparticles will be important,” and such studies are already underway.

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ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission, intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade.  ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS.  ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field.  According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time.

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The U.S. Environmental Protection Agency (EPA) published in an October 26, 2011, Federal Register notice its final 2010 Effluent Guidelines Program Plan, which includes a request for comment and information for its 2011 annual reviews. EPA requests information on a number of topics, including discharges of nanosilver from industrial manufacturing. EPA cites nanosilver’s use as an active pesticide ingredient, an antimicrobial in fabric; a preservative in textile products, and coating in drums in washing machines. EPA states that, since many of these uses have the potential to create a source of silver in wastewater discharges, it “is interested in gathering as much information as possible on the fate, transport and effects of nanosilver on the aquatic environment and human health.” Comments on EPA’s 2011 reviews are due November 25, 2011.

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On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances.  REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH.  After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint.  ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.

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In an October 28, 2011, Federal Register notice, the National Cancer Institute’s (NCI) Alliance for Nanotechnology in Cancer announced the initiation of “Translation of Nanotechnology in Cancer” (TONIC), a public private industry partnership intended to promote translational research and development opportunities of nanotechnology-based cancer solutions. The notice states that an immediate consequence of this effort is the formation of a consortium involving government and pharmaceutical and biotechnology companies. The consortium will evaluate “promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients.” According to the notice, membership in the TONIC consortium will be limited to companies that: (1) have a successful track record of translating diagnostics and drug formulations and reaching their regulatory approval; and (2) are engaged in the development of nanotechnology-based formulations with application to imaging, diagnostics, and therapy.

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On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2) human exposure assessment; (3) human health; (4) environment; (5) risk assessment and risk management methods; and (6) informatics and modeling. The Strategy also considers the ethical, legal, and societal implications (ELSI) of nanotechnology. NNI held a webinar on October 20, 2011, to announce the release of the Strategy, and Lynn L. Bergeson served on the panel. The Strategy, fact sheet, brochure, and webinar are available online.  NNI will post the panelist materials.

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On October 10, 2011, ACS Nano accepted an article entitled “Generation of Metal Nanoparticles from Silver and Copper Objects:  Nanoparticle Dynamics on Surfaces and Potential Sources of Nanoparticles in the Environment,” in which the authors monitor nanoparticles and their transformations under a variety of environmental conditions.  According to the authors, their studies reveal “unprecedented dynamic behavior” of silver nanoparticles on surfaces.  The authors hypothesize that nanoparticle production occurs through a process involving three stages:  (1) oxidation and dissolution of silver from the surface of the particle; (2) diffusion of silver ion across the surface in an adsorbed water layer; and (3) formation of new, smaller particles by chemical and/or photoreduction.  The authors investigated non-nanoscale sources of silver, including wire, jewelry, and eating utensils placed in contact with surfaces, and found that they also formed new nanoparticles.  According to the authors, copper objects display similar reactivity, suggesting that the phenomenon may be more general.  The authors conclude that “discovery that [silver nanoparticles and copper nanoparticles] are generated spontaneously from manmade objects implies that humans have long been in direct contact with these nanomaterials and that macroscale objects represent a potential source of incidental nanoparticles in the environment.”

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The National Nanotechnology Initiative (NNI) will hold a webinar on October 20, 2011, to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy, and to discuss the development of the Strategy and its key focus areas. Dr. John Howard, Co-Chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group, will serve as the moderator. Panelists will include:

• Dr. Treye Thomas, NEHI Working Group Co-Chair;
• Dr. Shaun Clancy, Evonik DeGussa Corporation;
• Dr. Janet Carter, Occupational Safety and Health Administration (OSHA); and
• Lynn L. Bergeson, Bergeson & Campbell, P.C.

The webinar will include a 20-minute question-and-answer segment following the presentations.

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On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. In his press release, Pryor noted that the FDA already has facilities in place, such as the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, that could conduct the scientific studies required by the bill. Pryor stated that there are over 800 known commercial uses of nanotechnology and over 1,300 consumer nanotechnology products available. The bill was referred to the Committee on Health, Education, Labor, and Pensions.

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Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on September 28, 2011, the availability of a review of the 2007-2009 literature on toxicological and health effects relating to six nanomaterials. NICNAS commissioned the review and analysis of literature concerning fullerenes, carbon nanotubes, and nanoforms of zinc oxide, titanium dioxide, cerium oxide, and silver. According to NICNAS, it chose these nanomaterials because it considers them “to already be in, or close to, commercial use in Australia.”  The goal of the review was to identify any available scientific evidence of important toxicological/health effects that had not been covered by the scope of previous reviews and therefore supplement currently available scientific information on these substances.

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On September 18, 2011, Nature Nanotechnology posted an article entitled “Cell entry of one-dimensional nanomaterials occurs by tip recognition and rotation.” The authors state that materials with high aspect ratio, such as carbon nanotubes (CNT) and asbestos fibers, have been shown to cause length-dependent toxicity in certain cells because these long materials prevent complete ingestion, which frustrates the cell. The authors note that, while “[b]iophysical models have been proposed to explain how spheres and elliptical nanostructures enter cells,” one-dimensional nanomaterials have not been examined. The authors show “experimentally and theoretically” that cylindrical one-dimensional nanomaterials, such as CNTs, enter cells through the tip first. The abstract states:

For nanotubes with end caps or carbon shells at their tips, uptake involves tip recognition through receptor binding, rotation that is driven by asymmetric elastic strain at the tube-bilayer interface, and near-vertical entry.  The precise angle of entry is governed by the relative timescales for tube rotation and receptor diffusion.  Nanotubes without caps or shells on their tips show a different mode of membrane interaction, posing an interesting question as to whether modifying the tips of tubes may help avoid frustrated uptake by cells.

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Earlier this month the Danish Environmental Protection Agency (DEPA) published a document entitled Survey on Basic Knowledge about Exposure and Potential Environmental and Health Risks for Selected Nanomaterials, which is intended to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials, and the possibility of exposure of humans and the environment.  DEPA selected fullerenes, iron, silver, nanoclay, and titanium, cerium, and silicon dioxides for the project.  Based on current uses, DEPA concluded that current applications of nano-iron and nano-clay cannot cause unexpected “nano-associated” health or environmental problems.  Although DEPA identified no specific risk associated with current uses of any of the identified nanomaterials, it concluded “there are areas where there may be reason for attention and thus need for more knowledge.”

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The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:

• Significant discussion about environmental, health, and safety (EHS) questions for nanotechnology-enabled products;
• Hands-on participation in joint programs of work that will better leverage resources; and
• Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.

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The European Commission (EC) announced on July 13, 2011, that European Union (EU)-funded scientists have developed risk assessment criteria for engineered nanomaterials “that will help support experts in making innovation and policy decisions.” According to the EC, findings reveal that product design can affect the unintentional release of engineered nanomaterials. The scientists suggest that the risk assessment criteria should be used to assess and minimize potential risks, which the EC states “would benefit those working in the building sector in particular, because it is estimated that nanomaterials will be used to develop 15% to 30% of facade coatings within the next 4 years.” The study is presented in the journal Environment International.

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On July 19, 2011, the National Nanotechnology Initiative (NNI) announced the release of four reports from a series of workshops focusing on issues in the nanotechnology environmental, health, and safety (EHS) arena. According to NNI, the workshops were a part of an ongoing strategy to coordinate nanotechnology-related EHS research by convening experts from industry, academia, and the federal government to share the latest information and newest developments, to discuss the current state-of-the-science, and to identify research gaps in the nanotechnology-related EHS field. NNI states that “knowledge gleaned from the nanoEHS workshop series was critical to the development of the soon-to-be-released, updated NNI EHS Research Strategy.”

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On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”

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Environmental Science & Technology posted on April 5, 2011, an article entitled “Behavior of Metallic Silver Nanoparticles in a Pilot Wastewater Treatment Plant.” The abstract states:

We investigated the behavior of metallic silver nanoparticles (Ag-NP) in a pilot wastewater treatment plant (WWTP) fed with municipal wastewater.  The treatment plant consisted of a nonaerated and an aerated tank and a secondary clarifier.  The average hydraulic retention time including the secondary clarifier was 1 day and the sludge age was 14 days.  Ag-NP were spiked into the nonaerated tank and samples were collected from the aerated tank and from the effluent.  Ag concentrations determined by inductively coupled plasma-mass spectrometry (ICP-MS) were in good agreement with predictions based on mass balance considerations.  Transmission electron microscopy (TEM) analyses confirmed that nanoscale Ag particles were sorbed to wastewater biosolids, both in the sludge and in the effluent.  Freely dispersed nanoscale Ag particles were only observed in the effluent during the initial pulse spike.  X-ray absorption spectroscopy (XAS) measurements indicated that most Ag in the sludge and in the effluent was present as Ag2S.  Results from batch experiments suggested that Ag-NP transformation to Ag2S occur[r]ed in the nonaerated tank within less than 2 h.  Physical and chemical transformations of Ag-NP in WWTPs control the fate, the transport and also the toxicity and the bioavailability of Ag-NP and therefore must be considered in future risk assessments.

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Inhalation Toxicology has published an article entitled “Exposure assessment of workplace manufacturing nanosized TiO₂ and silver,” which monitored the possible exposure to nanoparticles at workplaces that manufacture nano-titanium dioxide (TiO₂) and nano-silver.  The abstract states:

To estimate the potential exposure of workers, personal sampling, area monitoring, and real-time monitoring using a scanning mobility particle sizer (SMPS) and dust monitor were conducted at workplaces where the workers handle nanomaterials. The gravimetric concentrations of TiO₂ ranged from 0.10 to 4.99 mg/m³, which were lower than the occupational exposure limit 10 mg/m³ set by the Korean Ministry of Labor or American Conference of Governmental Industrial Hygienists (ACGIH). Meanwhile, the silver metal concentrations ranged from 0.00002 to 0.00118 mg/m³, which were also lower than the silver dust 0.1 mg/m³ and silver soluble compound 0.01 mg/m³ occupational exposure limits set by the ACGIH. The particle number concentrations at the nano-TiO₂ manufacturing workplaces ranged from 11,418 to 45,889 particles/cm³ with a size range of 15-710.5 nm during the reaction, although the concentration decreased to 14,000 particles/cm³ when the reaction was stopped. The particle concentrations at the TiO₂ manufacturing workplaces increased during the reactor and vacuum pump operations, and during the collection of the synthesized TiO₂ particles. Similarly, the particle concentrations at the silver nanoparticle manufacturing workplaces increased when the sodium citrates were weighed or reacted with the silver nitrates, and during the cleaning of the workplace. The number of silver nanoparticles in the samples obtained from the workplace manufacturing silver nanoparticles using induced coupled plasma ranged from 57,789 to 2,373,309 particles/cm³ inside the reactor with an average size of 20-30 nm and 535-25,022 particles/cm³ with a wide range of particle sizes due to agglomeration or aggregation after the release of nanoparticles into the workplace air. In contrast, the silver nanoparticles manufactured by the wet method ranged from 393 to 3526 particle[s]/cm³ with an average size of 50 nm.  Thus, when taken together, the TiO₂ and silver nanoparticle concentrations were relatively lower than existing occupational exposure limits.

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On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled “Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses included:

• Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO);
• Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
• Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
• Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
• Mr. William Moffitt, President and Chief Executive Officer, Nanosphere, Inc.

The witnesses emphasized the need for Congress to reauthorize the National Nanotechnology Initiative (NNI) to ensure that the U.S. remains the global leader in nanotechnology. Other countries, such as Japan, China, and South Korea, have increased their investment in nanotechnology. Representative Mo Brooks (R-AL), Chair of the Subcommittee, thanked Dr. Teague for his service as Director of the NNCO. Dr. Teague’s last day will be April 15, 2011.

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On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit interim progress reports to EPA at 60-day intervals, and a final report within 120 days of the conclusion of testing. Under the proposed testing agreement, if EPA promulgated a TSCA Section 5(a)(2) significant new use rule (SNUR) applicable to the test substances, then the testing agreement would have the status of a TSCA Section 5(b)(1)(A) test rule. The NanoSafety Consortium asked that EPA “expeditiously consider” the proposed testing agreement and begin the public comment and negotiation process at its “earliest possible convenience.”

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On March 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) announced that it seeks comment on the types of hazard identification and risk management research that it should consider in updating the NIOSH 2009 nanotechnology strategic plan. According to the Federal Register notice, NIOSH would like to build on the accomplishments of ongoing research to develop strategic research goals and objectives through 2015. Comments are due April 15, 2011.

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On February 17, 2011, the U.S. Environmental Protection Agency (EPA) announced that it awarded $5.5 million to three consortia to support innovative research on nanotechnology. EPA states that, in collaboration with the United Kingdom's (UK) Natural Environment Research Council, it is leading this scientific research effort to understand better the potential risks to people’s health and the environment. The grants EPA awarded are intended to help researchers determine whether certain nanomaterials can leach out of products such as paints, plastics, and fabrics when they are used or disposed of and whether they could become toxic to people and the environment.  According to EPA, the U.S. Consumer Product  Safety Commission (CPSC) has also contributed $500,000 through a new research partnership between the two agencies.  Grant awards were made to three consortia consisting of researchers from the U.S. and the UK Each U.S. team of researchers received $2 million from EPA and CPSC, for a total of $6 million. Each UK team will also receive $2 million from the UK agencies, resulting in a grand total of $12 million to conduct the research.

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On February 14, 2011, the Joint Research Centre (JRC) announced the creation of the first European repository of nanomaterials. According to JRC, the repository contains most types of nanomaterials that are currently assumed to be used in significant volumes in consumer products. The materials will be used as a reference point by laboratories that carry out safety assessments on nanomaterials, to make sure that their results are comparable to those of other laboratories. JRC states that this responds to a need expressed by experts in international standardization organizations. The new repository includes, among other materials, carbon nanotubes, silver nanoparticles, titanium dioxide, cerium oxide, zinc oxide, bentonite, gold, and silicon dioxide.

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Under the fiscal year (FY) 2012 budget request submitted by President Obama to Congress on February 14, 2011, funding for the National Nanotechnology Initiative (NNI) would increase by $201 million, to $2.1 billion. According to an Office of Science and Technology Policy (OSTP) fact sheet, agencies participating in the NNI have developed three signature initiatives in areas ready for advances through close and targeted program-level interagency collaboration: Nanoelectronics for 2020 and Beyond; Sustainable Manufacturing: Creating the Industries of the Future; and Nanotechnology for Solar Energy Collection and Conversion. Participating agencies will continue to support nanoscience and nanotechnology development through investigator-led research; multidisciplinary centers of excellence; education and training; and infrastructure and standards development. In addition, OSTP states, agencies will still maintain a focus on the responsible development of nanotechnology, with attention to potential human and environmental health impacts, as well as ethical, legal, and other societal issues. At a February 14, 2011, news briefing for reporters, OSTP Director John Holdren said budget reductions proposed by Republicans in Congress could be damaging if applied to federal research funding.

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This week the National Nanotechnology Initiative (NNI) and the White House Office of Science and Technology Policy (OSTP) released the 2011 NNI Strategic Plan. According to NNI, the Plan retains the “overall vision,” four goals, and eight program component areas outlined in the previous edition of the Plan, which was released in December 2007. For the first time, the Plan includes specific objectives under each goal, outlining concrete steps that NNI member agencies will take toward collectively achieving the NNI vision and goals.  NNI member agencies will use the Plan to guide the coordination of their research, training programs, and resources. NNI states that the Plan incorporates a broad rage of stakeholder input obtained through NNI-sponsored workshops, a formal Request for Information published in the Federal Register, and the NNI Strategy Portal website.

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On January 31, 2011, State Secretary for Infrastructure and the Environment, Joop Atsma, announced that joint investments in the development of nanotechnology made by the public and private sectors in the Netherlands must devote at least 15 percent of the investment to risk analyses. According to a spokesperson, the new requirement includes an €80 million ($110.4 million) investment approved by the previous government and matched by the private sector. The independent Committee for Societal Dialogue on Nanotechnology recently released a report that found citizens have a positive attitude about the opportunities offered by nanotechnology, but are concerned about the risks.

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On January 26, 2011, the International Organization for Standardization (ISO) announced the availability of a new standard, ISO 10808:2010, entitled “Nanotechnologies -- Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing.” The standard is intended to ensure that the results of inhalation toxicity tests of airborne nanoparticles are reliable and harmonized worldwide. According to ISO, the standard “establishes a battery of inhalation toxicity testing chamber monitoring, including a differential mobility analyzing system (DMAS), for determining particle number, size, size-distribution, surface area and estimated mass dose, as well as morphological examination using transmission electron microscopy (TEM) or scanning electron microscopy (SEM) equipped with an energy dispersive X-ray analyzer (EDXA) for chemical composition.”

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The Hohenstein Institute announced on January 10, 2011, that it completed a field study of the effect of antibacterial clothing containing nanosilver on skin flora and microclimate. According to the Institute, natural skin flora were unaffected, even after long periods of wear. A total of 60 healthy volunteers participated in the six-week study. Special t-shirts were made for the study, with an antibacterial treatment on one side (verum), while the other half served as a non-antibacterial placebo.  Researchers found that the skin flora and microclimate of healthy skin remained unaffected by the antibacterial t-shirts that were worn next to the skin:  no damage to the skin flora could be detected, i.e. no change to the total number of bacteria on the skin or variation in the range of bacteria.  The researchers concluded that the antibacterial textiles could, therefore, be classified as safe.  The researchers noted that, nevertheless, the antibacterial textiles are effective against bacteria entering the fabric in perspiration, as shown in previous studies.  The researchers intend to submit their data for publication in an internationally regarded specialist dermatology journal.

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The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
• Reporting Under TSCA Section 8(a) -- Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials.  According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2).  The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.

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On December 21, 2010, the California Department of Toxic Substances Control (CDTSC) issued a data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. According to CDTSC, Health and Safety Code Section 57018(a)(4) defines a “manufacturer” as a “person who produces a chemical in this state or imports a chemical into this state for sale in this state.”  Accordingly, CDTSC states, “persons and businesses who produce or import one or more of the above chemicals, in any quantity, must comply with the statute and this request.” CDTSC requests information about the analytical test methods that identify and quantify the specified nanomaterials, their metabolites, and their degradation products in water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine. CDTSC states it determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists.  To better understand the behavior, fate, and transport of these nanomaterials, CDTSC needs “appropriate analytical test methods” for manufacturers, contract and reference laboratories, and regulatory agencies.  CDTSC states that manufacturers “may be required to develop information consistent with the requirements of Health and Safety Code section 57019(c) and (d).” Manufacturers, including importers, must provide the requested information no later than one year from CDTSC’s December 21, 2010, letter, however, “timely attention and response is preferred.”

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The U.S. Environmental Protection Agency (EPA) announced in a December 13, 2010, Federal Register notice that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials. Registration is required to attend the meeting, and EPA states that space is limited. Comments may be submitted in writing or made orally during the meeting. Written comments are due December 28, 2010. EPA intends to consider all such comments in evaluating whether or how to develop further case studies and workshops on nanomaterials. To date, EPA has published two Nanomaterial Case Studies -- Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen (Final), and Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (External Review Draft).

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The White House Office of Science and Technology Policy (OSTP) and the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council request comments regarding the draft National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy (Strategy). The draft Strategy describes the National Nanotechnology Initiative’s (NNI) environmental, health, and safety (EHS) vision and mission, the state of the science, and the research needed to achieve the vision.  It represents the consensus of the participating agencies on how to promote the responsible development of nanotechnology by providing guidance to federal agencies as they develop their agency-specific research priorities, strategies, and implementation plans to achieve this vision.  It describes the goals and research needs for five science topics that shape EHS research (nanomaterial measurement infrastructure, human exposure assessment, human health, environment, and risk assessment and risk management methods) and evaluates the state of the science for each of these topics.  The draft Strategy also includes an analysis of the fiscal year 2009 federal EHS research portfolio and identifies concepts and approaches to accelerate the pace of research in this crucial area.  The 2011 plan will update and replace the 2008 NNI EHS Research Strategy. Comments are due January 6, 2011.

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On December 3, 2010, the Organization for Economic Cooperation and Development (OECD) posted two documents in its series on the safety of manufactured nanomaterials: 

• Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories -- OECD developed this document as part of its work on occupational exposure mitigation. The document compares existing published guidelines regarding the use of nanomaterials at the laboratory scale, including the manufacture and the use of products in industrial, institutional, and commercial settings. OECD states: “Since there are not globally standardized protection measures determined for nanomaterials, it is expected that this document is to be of interest for research laboratories and industrial enterprises that produce or process nanomaterials at the laboratory scale.”
 
• List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision -- OECD first published this document in 2008. It provides the list of representative manufactured nanomaterials and the list of endpoints for human health and environmental safety addressed by the Sponsorship Programme for the Testing of Manufactured Nanomaterials. OECD states that, based on the current state of knowledge, the Working Party on Manufactured Nanomaterials updated the list of manufactured nanomaterials by removing carbon black and polystyrene, and adding gold-nanoparticles.

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The National Institute for Occupational Safety and Health (NIOSH) released a draft Current Intelligence Bulletin (CIB) entitled Occupational Exposure to Carbon Nanotubes and Nanofibers, which recommends that, until results from research studies can fully elucidate the physicochemical properties of carbon nanotubes (CNT) and carbon nanofibers (CNF) that define their inhalation toxicity, employers should take steps to minimize CNT and CNF exposures of all workers and implement an occupational health surveillance program that includes elements of hazard and medical surveillance.  The draft CIB includes more specific recommendations for employers and workers to minimize potential health risks associated with exposure to CNTs and CNFs. NIOSH will hold a public meeting on the draft CIB on February 3, 2011, in Cincinnati, Ohio. According to NIOSH, during the meeting, it will place special emphasis on:

• Whether the hazard identification, risk estimation, and discussion of health effects for CNTs and CNFs are a reasonable reflection of the current understanding of the evidence in the scientific literature;
• Workplaces and occupations where exposure to CNTs and CNFs occur;
• Current strategies for controlling occupational exposure to CNTs and CNFs (e.g., engineering controls, work practices, personal protective equipment);
• Current exposure measurement methods and challenges in measuring workplace exposures to CNTs and CNFs; and
• Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).

Notification of intent to intend the meeting is due to NIOSH on January 28, 2011. Comments on the draft CIB are due February 18, 2011.

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The National Nanotechnology Initiative (NNI) draft Strategic Plan is available for comment until November 30, 2010. The Strategic Plan is the framework that underpins the work of the 25 NNI member agencies.  The Strategic Plan is intended to ensure that advances in nanotechnology research and development (R&D) and their applications to agency missions and the broader national interest continue. The purpose of the Strategic Plan is to facilitate achievement of the NNI vision by providing guidance for agency leaders, program managers, and the research community regarding planning and implementation of nanotechnology R&D investments and activities.

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The National Institute for Occupational Safety and Health (NIOSH) has posted an October 2010 Impact Sheet entitled “NIOSH Research Methods Demonstrate that Breathing Nanoparticles May Result in Damaging Health Effects,” which reports the results of recently published research concerning the health effects of inhaling single-walled carbon nanotubes. According to the Impact Sheet, NIOSH scientists invented a way to suspend nanotubes in air, thus allowing for control of the concentration of particles, unlike previous studies, which dosed the mice through aspiration. NIOSH scientists placed the mice into a controlled environment where they would breathe the air containing the particles, and studied the effects of exposure after one, seven, and 28 days.  The Impact Sheet states that, although the effects were similar, the new results “demonstrated that carbon nanotubes were more potent when inhaled than when aspirated.”  According to NIOSH, “this research has shown early indications of serious health outcomes that may have longer term effects such as cancer, and therefore, ongoing research is important to more clearly understand the implications of exposure to carbon nanotubes.  This study and continued NIOSH research could soon help the development of occupational safety and health recommendations for carbon nanotubes that will protect the health of nanotechnology workers.”

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The International Journal of Occupational and Environmental Health (IJOEH) has posted a special issue concerning human and environmental exposure assessment for nanomaterials. The issue includes articles such as “Understanding Workplace Processes and Factors that Determine Exposures to Engineered Nanomaterials,” “Nanotechnology and Exposure Science: What Is Needed to Fill the Research and Data Gaps for Consumer Products,” “Imaging and Characterization of Engineered Nanoparticles in Sunscreens by Electron Microscopy, under Wet and Dry Conditions,” and “Exposure Assessment:  Recommendations for Nanotechnology-Based Pesticides.”

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In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science.  NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000.  According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science.” Dennis E. Hourcade, Ph.D., Washington University, St. Louis, will receive funding for “Characterization/Bioinformatics-Modeling of Nanoparticle:  Complement Interactions.” NIH defines regulatory science as “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance.”

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The National Institute for Occupational Safety and Health (NIOSH) announced on September 22, 2010, that it entered into a formal partnership with the National Science Foundation (NSF) Center for High-Rate Nanomanufacturing (CHN) that is intended to provide companies with practical research and guidance to promote occupational health and safety in nanotechnology. Through the new partnership, University of Massachusetts (UMass) Lowell, CHN, and NIOSH will “address safety issues so that discoveries can quickly turn into commercially available products.” NIOSH and UMass Lowell research teams will evaluate potential exposure to nanomaterials and recommend solutions at small- to medium-sized companies and research laboratories. NIOSH will publish best practices developed by UMass Lowell and CHN. UMass Lowell will host and NIOSH will co-sponsor the 5th International Symposium on Nanotechnology, Occupational, and Environmental Health on August 9-12, 2011, in Boston.

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On September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and the U.S. Environmental Protection Agency (EPA) held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California’s data call-in (DCI) for carbon nanotubes (CNT), its plans for future DCIs, and EPA’s efforts related to CNTs. The candidate chemicals for CDTSC’s second DCI, which it intends to issue this Fall, include nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. CDTSC may also include in the DCI a request for more information concerning CNTs incorporated in nanometals. According to CDTSC, the DCI will focus its initial questions on analytical test methods for the respective nanomaterial chemical, as well as its metabolites and breakdown products, in various matrices. The meeting presentations for each of the DCI candidates include more specific information regarding applications, production, human health and environmental concerns, why CDTSC is interested, and possible DCI questions.

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The California Department of Toxic Substances Control (CDTSC) has rescheduled its workshop on state and federal nanomaterial activities for September 22, 2010. CDTSC, the U.S. Environmental Protection Agency (EPA), and the University of California, Los Angeles (UCLA) are cosponsoring the workshop to discuss the results of California’s carbon nanotube (CNT) information call-in, future data call-in requests for additional nanomaterials, and federal efforts related to CNTs for nanomaterials. The workshop is open to the public.

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The August 2010 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an article regarding the Intramural NanoHealth Signature Program, which is intended to investigate the health effects of engineered nanomaterials (ENM) in susceptible populations. According to the article, ENMs are increasingly found in medications, cosmetics, electronics, and other consumer products, creating environmental as well as occupational exposures. Over the next three years, researchers in the Clinical Research Unit (CRU) will engage in bidirectional collaborations with the National Toxicology Program (NTP), labs in the NIEHS intramural program, and the U.S. Environmental Protection Agency (EPA) as they explore the effects of exposure among healthy and susceptible populations to ENMs that are already present in the atmosphere.  The team will study the effects in cells tissue, animals, and human subjects. The research team will test the hypothesis that selected engineered nanomaterials induce pulmonary inflammation and that asthmatic individuals are particularly susceptible to ENM effects, in a translational exposure model with three aims:

• Exposing human bronchial epithelia and alveolar macrophages -- native lungs cells donated by healthy volunteers -- to ENMs ex vivo to evaluate inflammation and cell toxicity;
• Comparing the ex vivo response to ENMs of human bronchial epithelia and alveolar macrophages between healthy and asthmatic individuals to understand whether pre-existing disease alters the effect of ENMs on human cells; and
• Performing controlled chamber exposures of human volunteers to select ENMs of interest to assess the potential for effects on lung function and inflammation.

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On June 8, 2010, the Organization for Economic Cooperation and Development (OECD) announced the publication of two materials for use in the OECD Sponsorship Programme. The first is a revision of the Guidance Manual for the Testing of Manufactured Nanomaterials. According to OECD, the revised Guidance “is intended to support the testing undertaken in the context of OECD’S Sponsorship Programme and to ensure that the information collected from this testing programme be reliable, accurate, and consistent.” OECD states that the second document, entitled Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, was published to assist the sponsors of the OECD Sponsorship Program, as well as to help others involved in the safety testing of manufactured nanomaterials.

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The President’s Council of Advisors on Science and Technology (PCAST) seeks comment from stakeholders on how the federal government can best use its resources so three of the “newest and most promising technologies,” including nanotechnology, “provide the greatest economic benefits to society.” The President’s Innovation and Technology Advisory Committee (PITAC), which is part of PCAST, is soliciting information and ideas from stakeholders -- including the research community, the private sector, universities, national laboratories, state and local governments, foundations, and nonprofit organizations -- regarding the “Golden Triangle.” Each side of the Golden Triangle represents one of three areas of research that together are transforming the technology landscape today: information technology, biotechnology, and nanotechnology.

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On May 28, 2010, the House passed, by a vote of 262-150, the America COMPETES Reauthorization Act of 2010 (H.R. 5116), which would authorize funding for the National Nanotechnology Initiative (NNI), as well as the National Science Foundation (NSF), National Institute of Standards and Technology (NIST), and Department of Energy (DOE) Office of Science activities. The bill includes language from H.R. 554, the NNI Amendments Act of 2009, which the House passed in February 2009. H.R. 5116 would require NNI to work toward developing “standards related to methods and procedures for detecting, measuring, monitoring, sampling, and testing engineered nanoscale materials for environmental, health, and safety impacts.” The bill would fund research on “green nanotechnology” by creating research centers that would focus on methods and approaches to develop environmentally benign nanoscale products and nanoscale manufacturing processes; foster the transfer of the results of such research to industry; and provide for the education of scientists and engineers through interdisciplinary studies in the principles and techniques for the design and development of environmentally benign nanoscale products and processes. The bill would create a position, within the Office of Science and Technology Policy (OSTP), for a Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would ensure that a research plan for the environmental, health, and safety (EHS) research activities is developed, updated, and implemented.

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The National Institute for Occupational Safety and Health (NIOSH) announced that laboratory studies, reported in a paper posted online by the journal Nature Nanotechnology on April 4, 2010, discovered that carbon nanotubes were biodegraded by an enzyme found in white blood cells, neutrophils.  According to NIOSH, the researchers demonstrated that, unlike carbon nanotubes that were not biodegraded in this way, the biodegraded nanotubes did not cause inflammation in the lungs of mice.  NIOSH states that the results are important for scientists in evaluating the biological effects of carbon nanotubes, particularly their fate and role in inflammation, and that more research would be needed for determining the applicability of the findings in assessing potential risk in occupational exposures.

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In a February 15, 2010, article entitled “ZnO Particulate Matter Requires Cell Contact for Toxicity in Human Colon Cancer Cells,” researchers report their results of a comparison of the toxicity of two commercial types of zinc oxide (ZnO) to colon cells. According to the researchers, the nano-sized ZnO was more cytotoxic than micrometer-sized ZnO. The researchers state: “Unintended exposure to nano-sized zinc oxide from children accidentally eating sunscreen products is a typical public concern, motivating the study of the effects of nanomaterials in the colon.” The article will be published in Chemical Research in Toxicology.

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On April 5, 2010, the U.S. Environmental Protection Agency (EPA) announced that its Small Business Innovation Research (SBIR) Program awarded $2.38 million to 34 small businesses to develop “innovative, sustainable technologies to protect human health and the environment.” The awards focus on the following environmental research areas: increasing the efficiency of green building materials and systems; manufacturing innovation; prevention, monitoring, and control using nanotechnology; reducing greenhouse gases; new treatment technologies for drinking water; improving water infrastructure; reducing emissions from small air pollution sources and vehicles and biofuels production facilities; new approaches for cleaning up and monitoring hazardous waste sites; and new tools for homeland security systems. Examples of new technologies include NEI Corporation, which will develop a “self-healing nanocomposite to protect drinking water pipes from corrosion.” EPA is also requesting applications for the development of new environmental technologies. Applications are due May 11, 2010.

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On March 4, 2010, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) Program announced a partnership led by the DfE Program and Office of Research and Development (ORD). The partnership is conducting a screening-level life-cycle assessment of currently manufactured lithium-ion battery technologies and a next generation battery component that uses single-wall carbon nanotube technology. According to the DfE Program, the partnership offers the opportunity to mitigate current and future impacts and risks by helping battery manufacturers and suppliers identify materials and/or processes associated with the greatest environmental impacts throughout the life cycle of their products, and identify areas that could benefit from increased energy efficiency.

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During the 68th annual meeting of the American Academy of Dermatology, on March 4, 2010, dermatologist Adnan Nasir, M.D., Ph.D., F.A.A.D., gave a presentation on nanotechnology and how nanoparticles may eventually be used in cosmetic products. According to Dr. Nasir, the cosmetic industry leads all other industries in the number of patents for nanoparticles, which have the potential to enhance sunscreens, shampoos, conditioners, lipsticks, eye shadows, moisturizers, deodorants, after-shave products, and perfumes.  Nanoparticles used in sunscreens increase protection and coverage on the skin, while being less visible than microparticles. In anti-aging products, nanotechnology may allow active ingredients to penetrate the top layer of the skin. Researchers are currently exploring nanoparticle treatments of conditions such as melanoma.  Dr. Nasir noted, however, that dermatologists are concerned about the potential health risks posed by nanotechnology, and “anxiously await” the Food and Drug Administration’s review of the safety of nanoparticles.

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On January 19, 2010, the National Institute for Occupational Safety and Health (NIOSH) announced three new peer-reviewed articles co-authored by NIOSH researchers. According to NIOSH, the articles report findings and conclusions from studies that examined issues related to potential occupational exposure to engineered nanomaterials. Two articles in the Journal of Occupational and Environmental Hygiene report on the design and application of the nanomaterial emission assessment technique, which was developed by the NIOSH nanotechnology field evaluation team. Part A describes the technique (Journal of Occupational and Environmental Hygiene, 7:127-132), while Part B discusses findings from use of the technique at 12 facilities. NIOSH states that the results summarized in Part B “demonstrated that the technique is useful in identifying and evaluating sources of nanomaterial emissions, and for evaluating engineering controls intended to minimize emissions and reduce exposures” (Journal of Occupational and Environmental Hygiene, 7:163-176). The third article, highlighted as a “featured research” paper in EHP, examines the potential for occupational exposure to engineered carbon-based nanomaterials in environmental laboratory studies. The article cautions that under some conditions, engineered nanomaterials can become airborne when mixed in solution by sonication.

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Last month, Bayer Material Science (BMS) announced that it derived an occupational exposure limit (OEL) of 0.05 milligrams per cubic meter (mg/m³) for Baytubes, BMS multi-wall carbon nanotubes. According to BMS, “[t]he latest results of sub-chronic inhalation studies support the conclusion that Baytubes act like poorly soluble particles.” BMS derived the OEL based on previous single and recent repeated inhalation studies. BMS states: “All relevant information are now included in the updated Safety Data Sheet and will further ensure that our customers work safely with our Baytubes.”

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The National Institute for Occupational Safety and Health (NIOSH) announced that it will hold a conference entitled “Nanomaterials and Worker Health:  Medical Surveillance, Exposure Registries, and Epidemiologic Research,” on July 21-23, 2010, at the Keystone Resort and Conference Center in Keystone, Colorado. According to NIOSH, the goal of the conference is to identify gaps in information and address questions focusing on occupational health surveillance, exposure registries, and epidemiologic research involving nanotechnology workers.  The conference will include invited and submitted papers, breakout sessions to allow for small group discussions, and poster presentation.

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On November 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) released two nanotechnology publications. NOISH posted a document entitled Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008. The Report updates the February 2007 version, which described the progress of the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006. In the November 2009 Report, NIOSH describes program accomplishments achieved in 2007 and 2008. NIOSH states that the NTRC has, with limited resources, continued to make contributions to all the steps in the continuum from hazard identification to risk management. The second document, entitled Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge Gaps, updates the September 2005 Strategic Plan using knowledge gained from results of ongoing research as described in the 2007 report Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center and the 2009 update. NIOSH states that the Strategic Plan for the nanotechnology program is the roadmap it is using to advance knowledge about the implications and applications of nanomaterials.

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On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant progress on all points in the Action Plan. The Communication notes that, “[a]s a general remark, the past two years have seen a substantial development of nanotechnology, supported by a further growth in research funding and the active development of policy. . . . In view of this, efforts to address societal and safety concerns must be continued to ensure the safe and sustainable development of nanotechnology.” The Communication states that the EC “is considering proposing a new Nanotechnology Action Plan that would be one of the driving forces of the European Research Area and address important societal and environmental issues.”

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On October 23, 2009, EHP-in-Press posted an article entitled “Evaluation of Silver Nanoparticle Toxicity in vivo Skin and in vitro Keratinocytes,” which assesses the potential cytotoxicity of silver nanoparticles in human epidermal keratinocytes, and their inflammatory and penetrating potential into porcine skin in vivo. According to the article, silver nanoparticles are non-toxic when dosed in washed silver nanoparticle solutions or carbon-coated. The authors conclude that their study “provides a better understanding [of silver nanoparticles] safety in vitro as well as in vivo and a basis for occupational and risk assessment.” EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

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On September 30, 2009, the U.S. Environmental Protection Agency (EPA) announced the availability of the Nanomaterial Research Strategy (Strategy), which EPA describes as its new research strategy to understand better how manufactured nanomaterials may harm human health and the environment.  The Strategy outlines what research EPA intends to support over the next several years to generate information about the safe use of nanotechnology and products that contain nanoscale materials.  The Strategy also includes research into ways nanotechnology can be used to clean up toxic chemicals in the environment.  In its announcement, EPA states that its role among federal agencies “is to determine the potential hazards of nanotechnology and develop approaches to reduce or minimize any risks identified.  As part of the strategy, researchers are investigating widely used nanomaterials, such as carbon nanotubes, which are used in vehicles, sports equipment and electronics; and titanium dioxide, which is used in paints, cosmetics and sunscreens.”

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On September 23, 2009, EHP-in-Press posted an article entitled “Potential for Occupational Exposure to Engineered Carbon-Based Nanomaterials in Environmental Laboratory Studies,” which states that laboratory workers may be at increased risk of exposure to engineered nanomaterials. The goal of the study was to assess the release of carbonaceous nanomaterials into the laboratory atmosphere during handling and sonication into environmentally-relevant matrices. The authors concluded that engineered nanomaterials can become airborne when mixed in solution by sonication, especially when nanomaterials are functionalized or in water containing natural organic matter. EHP-in-Press articles have been peer reviewed and accepted for publication in Environmental Health Perspectives.

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The U.S. Environmental Protection Agency (EPA) has announced the Interagency Nanotechnology Implications Grantees Workshop, which will feature presentations on recent research by EPA, the National Science Foundation (NSF), National Institutes of Health, National Institute of Environmental Health Sciences (NIH/NIEHS), National Institute for Occupational Safety and Health (NIOSH), and Department of Energy (DOE) grant researchers.  According to EPA, the November 9-10, 2009, meeting “will encourage collaboration and cooperation among nanotechnology grantees sponsored by EPA, NSF, NIEHS, NIOSH and DOE and between other federal grantees and federal nanotechnology researchers.” The meeting is open to members of academia, government, nongovernmental organizations, industry, and the general public. Two agendas are available: (1) other nanomaterials; and (2) metals and carbon-based nanomaterials.

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The September 2009 issue of the European Respiratory Journal will contain a study entitled “Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma.”  The study examines the relationship between a group of workers presenting with “mysterious” symptomatic findings and their nanoparticle exposure. The authors conducted surveys of the workplace, made clinical observations, and examined the patients -- seven young female workers (aged 18 to 47 years), exposed to nanoparticles for five to 13 months, all with shortness of breath and pleural effusions.  According to the study abstract, polyacrylate, consisting of nanoparticles, was confirmed in the workplace.  Using transmission electron microscopy, nanoparticles were observed to lodge in the cytoplasm and caryoplasm of pulmonary epithelial and mesothelial cells, but are also located in the chest fluid.  The authors state that these cases “arouse concern that long-term exposure to some nanoparticles without protective measures may be related to serious damage to human lungs.” The study is not yet available on the European Respiratory Journal website.

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On July 29, 2009, Particle and Fibre Toxicology posted an article entitled “Maternal Exposure to Nanoparticulate Titanium Dioxide During the Prenatal Period Alters Gene Expression Related to Brain Development in the Mouse.” The purpose of the study was to investigate the effects of maternal exposure to nano-sized anatase titanium dioxide on gene expression in the brain during the developmental period. According to the authors, analysis of gene expression indicated that expression levels of genes associated with apoptosis were altered in the brain of newborn pups, and those associated with brain development were altered in early age. Genes associated with response to oxidative stress were changed in the brains of two- and three-week old mice. The authors concluded that maternal exposure of mice to titanium dioxide nanoparticles “may affect the expression of genes related to the development and function of the central nervous system.” A July 17, 2009, ACS Nano article entitled “Cellular Toxicity of TiO₂-Based Nanofilaments” concludes that titanium dioxide-based nanofilaments “are cytotoxic and thus precautions should be taken during their manipulation.” The authors studied the cellular toxicity of titanium dioxide-based nanofilaments in relation to their morphology and surface chemistry.

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