Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

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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