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

On June 22, 2007, the U.S. Environmental Protection Agency (EPA) announced the award of two research grants totaling almost $600,000 to scientists at Oregon State University, who will evaluate whether some engineered nanomaterials adversely affect human health. Under the first research grant, scientists will review a variety of commonly manufactured nanomaterials to determine their potential interactions with biological processes; if the researchers find nanomaterials that produce adverse human health effects, they will seek to identify the potential cellular and genetic targets of those nanomaterials and group the nanomaterials by composition and effects. The second research grant will focus on how engineered nanomaterials can damage or kill cells, and is expected to lead to the development of occupational and environmental exposure guidelines.

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On June 21, 2007, Environmental Defense (ED) and DuPont, who commenced a partnership on nanotechnology in September 2005, released the final Nano Risk Framework, which establishes “a systematic and disciplined process for identifying, managing, and reducing potential environmental, health, and safety risks of engineered nanomaterials across all stages of a product’s ‘lifecycle.’” The Framework is aimed primarily at organizations, both private and public, that are actively working with nanomaterials and developing associated products and applications. ED and DuPont believe that “adoption of the Frameworkcan promote responsible development of nanotechnology products, facilitate public acceptance, and support the formulation of a practical model for reasonable government policy on nanotechnology safety.”

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The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax, computer chips, and sunscreen, and that approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology by 2014, up from $50 billion in 2006. Consumers Union (CU), the nonprofit publisher of Consumer Reports, concludes that the responsibility for protecting consumers rests mainly with government and industry.  In particular, CU believes that the government should provide more funds for risk research and regulation, and that the Food and Drug Administration (FDA) should assess safety information on nanoingredients in cosmetics, food additives, and other products before they are sold, and should require manufacturers to report health problems linked with those ingredients. The full article is available in the July 2007 issue of Consumer Reports.

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On May 11, 2007, the United Kingdom (UK) Health & Safety Executive (HSE) published its first bulletin on nanotechnology research. The bulletin is intended to provide an overview of published studies that have examined the exposure and potential health effects of nanomaterials, particularly in the occupational setting. According to HSE, inevitably there will be some overlap between studies of exposure of other groups (i.e. consumers).  HSE screened the literature search results to ensure that the studies listed are relevant to HSE and its responsibility to manage health and safety in the workplace. The first bulletin reviews literature published in 2000-2006. According to HSE, subsequent bulletins will summarize publications from the previous four-month period. The bulletins will summarize the range of studies that have been published in two areas of interest: measurement, characterization, and control of exposure to nanoparticles; and potential for toxic effects of nanoparticles in humans.

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On May 10, 2007, EHP-in-Press posted an article entitled “Reviewing the Environmental and Human Health Knowledge Base of Carbon Nanotubes.” The authors reviewed the currently available literature about the human health and environmental risk potential of carbon nanotubes (CNT). The authors also investigated the life cycle of the CNT, as release into different environmental compartments may occur at the production stages as well as the product’s usage and disposal stages, which may indirectly or directly cause human exposure. Because, according to the authors, the published literature revealed many open questions, they also systematically interviewed seven leading scientists worldwide and integrated their contemporary knowledge in the review. The authors interviewed scientists who were key authors or project leaders, having investigated and reported the potential impacts of CNT on human health or environment. Through this combined approach, the authors present an updated and contemporary knowledge base for scientific discussion.

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Environmental Defense (ED) will hold a webcast regarding its recent report, Not That Innocent: A Comparative Analysis of Canadian, European Union and United States Policies on Industrial Chemicals, on May 24, 2007, from 3:00 p.m. to 4:30 p.m. (EDT). The webcast will include a 45-minute presentation and a question and answer period. Dr. Richard Denison, Senior Scientist at ED, will present the findings and discuss his report, which compares the European Union’s new Registration, Evaluation, and Authorization of Chemicals (REACH) regulation, the Toxic Substances Control Act (TSCA), and the Canadian Environmental Protection Act (CEPA).

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On April 11, 2007, the European Commission (EC) announced that the report prepared by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) regarding the appropriateness of the risk assessment methodology for assessing the risks of nanomaterials is available for comment. Comments are due May 23, 2007. EC states that the report “provides the Commission with a sound scientific approach on how to modify the Technical Guidance Documents of the EU chemicals legislation in regard to nanomaterials. The report provides proposals for general and specific modifications of risk assessment of human health and the environment, describes a staged strategy for the risk assessment of nanomaterials and identifies areas of further research.”

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On April 3, 2007, the United Kingdom’s (UK) Department of Environment, Food, and Rural Affairs (DEFRA) released its second quarterly update on the Voluntary Reporting Scheme (VRS) for engineered nanoscale materials. According to the update, DEFRA has received a total of six submissions since VRS’s launch in September 2006, four of which were from industry and two from academia. DEFRA has liaised with groups representing the UK nanotechnologies industry and has made direct contact with companies involved in the sector. From these contacts, DEFRA believes that “a number of VRS submissions are being prepared and will be delivered” in the near future. During discussions with industry, DEFRA sought feedback on VRS, and industry raised the following issues: uncertainty regarding the scope of VRS; resources; and confidentiality issues. The next update will be published in June 2007.

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The International Council on Nanotechnology (ICON) and Rice University’s Center for Biological and Environmental Nanotechnology (CBEN) announced on March 22, 2007, they have launched a monthly online journal that contains citations and links to articles on the environment and health impacts of nanotechnology. The ICON and CBEN coalition launched the first online database of nanomaterial scientific findings in August 2005, but the new journal -- The Virtual Journal of Nanotechnology Environment, Health & Safety (VJ-Nano EHS) -- “has taken the concept one step further,” the coalition said. The virtual journal organizes the information contained in the existing database into a reader-friendly monthly journal format. New features include a rotating guest editorship and a series of papers on topics of interest taken from the database. Contents of the journal are searchable. In the future, the coalition said, the journal will include a section on the most cited nanotechnology environment, health, and safety papers.

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On January 22, 2007, ISO published a report entitled Workplace Atmospheres -- Ultrafine, Nanoparticle and Nano-Structured Aerosols -- Inhalation Exposure Characterization and Assessment, which includes information on the potential health effects of nanoaerosols, sources of occupational nanoaerosols, exposure assessment strategies, particle ensemble characterization methods, size-resolved characterization, online chemical analysis, single particle analysis, and electron microscopy sample collection and preparation. The report states that its aim is “to provide generally accepted definitions and terms, as well as guidelines on measuring occupational nanoaerosol exposure against a range of metrics.” ISO intends the report to address an immediate need and establish an essential step for developing future exposure assessment standards for nanoaerosols.

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On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

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In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.”

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In February 2007, the National Institute for Occupational Safety and Health (NIOSH) released a report entitled Progress Toward Safe Nanotechnology in the Workplace, which summarizes the progress made by the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006.  According to NIOSH, by redirecting existing resources, NTRC developed a research program that has made progress towards hazard identification and characterization, exposure assessment, risk assessment, and risk management.

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