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

On August 25, 2009, the United States Consumer Product Safety Commission (CPSC) held a public hearing to receive comments about its agenda and priorities for CPSC during fiscal year (FY) 2011, which begins October 1, 2010, and about its current strategic plan. CPSC invited participation by members of the public, and representatives from the Consumers Union, Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN), Thermo Fisher Scientific, National Association of State Fire Marshals, International Sleep Products Association, Kids in Danger, and American Apparel & Footwear Association testified. Don Mays, Consumers Union, and David Rejeski, PEN, addressed CPSC’s goals concerning nanomaterials.

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Bergeson & Campbell, P.C. is pleased to announce that Lynn L. Bergeson will be speaking at the September 10-11, 2009, international conference on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. The London School of Economics, Chatham House, the Environmental Law Institute, and the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars have spent the past year examining issues of transatlantic regulatory cooperation. During the conference, their research findings will be published in a major report, which is scheduled to be released on September 10, 2009. The conference is intended to bring together regulatory experts from the United States (US) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future.

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Yesterday the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) announced that its inventory of nanotechnology-enabled consumer products includes over 1,000 items. When PEN began the inventory in March 2006, it included 212 products. According to PEN, health and fitness items represent 60 percent of the products listed. More products are based on nanoscale silver than any other nanomaterial, with 259 products (26 percent of the inventory) using silver nanoparticles. The inventory includes products from over 24 countries, including the U.S., China, Canada, and Germany. The inventory includes products that have been identified by their manufacturer or a credible source as being nanotechnology-based. PEN states that this update identifies products that were previously sold, but which may no longer be available. PEN encourages users to submit new and updated information.

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On August 18, 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released data showing that more than 1,200 companies, universities, government laboratories, and other organizations are involved in nanotechnology research, development, and commercialization. According to PEN, this is a 50 percent increase from the 800 organizations it identified two years ago. The data are part of PEN’s interactive map displaying the growing “Nano Metro” landscape, powered by Google Maps®. PEN’s accompanying analysis ranks cities and states by numbers of companies, academic and government research centers, and organizations and technology focus by sector.

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Today’s Federal Register includes a notice from the U.S. Environmental Protection Agency (EPA) withdrawing the June 24, 2009, final significant new use rules (SNUR) for multi- and single-walled carbon nanotubes (CNT). EPA states that it published the final SNURs using direct final rulemaking procedures. Because EPA received a notice of intent to submit adverse comments on the rules, it is withdrawing the SNURs for CNTs. The Federal Register notice does not identify the commenter. The docket for the rulemaking includes a July 22, 2009, letter from WilmerHale stating that it intends to submit adverse comments on behalf of one or more clients. According to the notice, EPA “intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURS for these two chemical substances.” The withdrawal is effective August 21, 2009.

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The August 2009 issue of Nature Nanotechnology includes an article entitled “Essential Features for Proactive Risk Management,” written by Vladimir Murashov, Ph.D., Special Assistant to the Director of the National Institute for Occupational Safety and Health (NIOSH), and John Howard, M.D., former NIOSH Director. The authors “propose a proactive approach to the management of occupational health risks in emerging technologies based on six features:  qualitative risk assessment; the ability to adapt strategies and refine requirements; an appropriate level of precaution; global applicability; the ability to elicit voluntary cooperation by companies; and stakeholder involvement.”

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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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According to its website, the National Institute for Occupational Safety and Health (NIOSH) has joined the International Journal of Occupational and Environmental Health in inviting submission of scientific papers for a special issue of the Journal. The special edition is provisionally entitled “Human and Environmental Exposure Assessment for Nanomaterials,” and will be edited by Vladimir Murashov, Ph.D., a special assistant to the NIOSH Director. Submissions are due January 15, 2010. More information about submission requirements can be found on the Journal’s website.

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In an August 7, 2009, letter to the White House Office of Science Technology and Policy (OSTP), the Environmental Council of the States (ECOS) expressed its interest in working with OSTP and other federal agencies regarding the “human health and ecological impacts and lifecycle consequences of intentional and unintentional releases of engineered nanoparticles into the environment.” According to ECOS, state environmental agencies want to participate in national efforts to develop best assessment and management practices. ECOS suggests that one option is for ECOS to join one or more of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee Working Groups within the National Nanotechnology Initiative (NNI) framework. ECOS asked OSTP for a meeting, “preferably this summer,” to obtain feedback on its key areas of interest and to discuss the best opportunities for its involvement in national efforts.

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In a notice in the August 4, 2009, Federal Register, the Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) released its latest report to the Administrator. Under TSCA Section 4(e), the ITC is required ‘‘to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of rules for testing.” According to the report, “the ITC has no revisions to the TSCA section 4(e) Priority Testing List at this time.”

The report also describes the ITC’s emphasis during the reporting period (November 2008 to May 2009) on nanoscale materials and how best to regulate them. It summarizes the ITC’s recent reviews of the U.S. Environmental Protection Agency’s (EPA) Nanoscale Materials Stewardship Program’s interim report and the National Institute for Occupational Safety and Health’s (NIOSH) nanotechnology guidelines. The report concludes by recommending data needs of ITC organizations be addressed and lists many of the data deficiencies.

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The Royal Society and Royal Academy of Engineering released on July 29, 2004, their report entitled Nanoscience and Nanotechnologies:  Opportunities and Uncertainties. To mark the five-year anniversary of the report, The Responsible Nano Forum invited representatives from science, risk, investment, non-governmental organizations (NGO), unions, business, and consumer groups to reflect on the legacy of the report and what still remains to be done. The report, A Beacon or Just a Landmark?  Reflections on the 2004 Royal Society/Royal Academy of Engineering Report, includes contributions from a range of individuals and organizations in the United Kingdom and internationally. We are pleased to announce that Lynn L. Bergeson is a contributor.

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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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On July 28, 2009, the U.S. Environmental Protection Agency (EPA) clarified its June 24, 2009, final Significant New Use Rules (SNUR) for multi- and single-walled carbon nanotubes (CNT).  According to EPA, upon review of the final rule, stakeholders asked whether the SNURs applied to all types of CNTs.  EPA responded:

This is not the case.  These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMN) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA's New Chemicals Program.  The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.

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