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

The European Commission (EC) announced that it will hold the fourth annual Nanotechnology Safety for Success Dialogue Workshop on March 29-30, 2011, in Brussels, Belgium. According to the EC, many market modelers identify nanotechnologies as drivers of economic growth, and as a consequence, many governments have adopted ambitious plans intended to ensure the commercial success of nanotechnologies. At the same time, the number of potential and real applications is increasing rapidly.  The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).  A number of regulatory developments have taken place while the science was also advancing.  The EC is convening the Workshop to:

• Take stock of the fast advancing science needed for appropriate and effective policies; and
• Analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design.

Registration to participate on location or via web streaming is open until March 1, 2011.

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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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On January 25, 2011, the European Agency for Safety and Health at Work (EU-OSHA) announced that French Agency for Environmental and Occupational Health Safety (ANSES) experts have developed a control banding tool specific to nanomaterials that can potentially be used in any work environment in which nanomaterials are manufactured or used. With control banding, new products are classified into “bands,” which are defined after comparison with the hazard level of known and/or similar products, while taking into account the assessment of exposure at the work station. The process combines a qualitative risk assessment with a risk control band and proposes minimum collective preventive measures to be implemented that are consistent with the estimated level of risk.  EU-OSHA notes that, “[i]n particular, the proposed tool is especially adapted to [small- and medium-sized enterprises (SME)] which do not necessarily have at their disposal the metrological characterisation equipment or detailed toxicological studies required for a proper risk assessment process.”

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On January 10, 2011, Environmental Science & Technology posted a peer-reviewed pre-publication article entitled “120 Years of Nanosilver History:  Implications for Policy Makers,” which shows that nanosilver in the form of colloidal silver has been used for more than 100 years and, according to the authors, has been registered as a biocidal material in the U.S. since 1954.  The article states that 53 percent of the U.S. Environmental Protection Agency (EPA)-registered biocidal silver products likely contain nanosilver and most of the applications are silver-impregnated water filters, algicides, and antimicrobial additives that do not claim to contain nanoparticles.  The authors state: “The implications of this analysis for policy of nanosilver is that it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a bid to declare nanosilver materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature to the term ‘nano.’”

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On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011.

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B&C Consortia Management, L.L.C. (BCCM) is working with BASF Corporation (BASF) to create a consortium to provide the California Department of Toxic Substances Control (CDTSC) information on analytical methods that could be used to measure certain nanoscale materials in air, surface water, and soil.  The collaborative project will involve adapting known methods used to measure these substances in other media to the analysis of environmental media.  The term of the consortium will be at least two years, which can be modified by mutual agreement. On December 21, 2010, 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. Experts within BASF will address issues concerning titanium dioxide and zinc oxide. BASF and BCCM seek other companies and experts to offer similar expertise for the remaining nanomaterials of interest and provide CDTSC with the help it needs.

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On December 17, 2010, ETC Group published a report entitled The Big Downturn?  Nanogeopolitics, which updates its 2005 nanogeopolitics survey. According to ETC Group, since 2005, policymakers have begun to acknowledge that fast-tracking nanotechnology has come at a price and that some sort of regulation is necessary to address at least some of the risks posed.  ETC Group states, though, that “governments and industry, hand in hand, have come too far and invested too much to give up on nanotech’s promise of becoming the strategic platform for global control of manufacturing, food, agriculture and health -- a pillar of the 21st century’s ‘green economy.’”  ETC Group provides an update on the geopolitical landscape, producing a current snapshot of global investment, markets, governance, and control, including intellectual property. ETC Group is hopeful that the risks of nanotechnology will be addressed in fora such as the International Labour Organization (ILO) XIX World Congress on Safety and Health at Work in Istanbul in September 2011 and the United Nations (UN) Rio+20 Summit in 2012.

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We are pleased to announce that NanoBusiness Alliance (NbA) has selected Lynn L. Bergeson as one of its “Most Influential Nanotechnology Leaders from 2010.” The NbA is the industry association for the emerging nanotechnology industry. Through its extensive network of leading start-ups, Fortune 500 companies, research institutions, non-governmental organizations, and public-private partnerships, the NbA shapes nanotechnology policy and helps accelerate the responsible commercialization of nanotechnology innovation. On July 1, 2010, the NbA issued a Position Statement on Nanomaterials Product Sustainability, which reflects its members’ “enduring commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.”

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Nature Nanotechnology has posted a pre-publication version of an article entitled “Science Policy Considerations for Responsible Nanotechnology Decisions,” which is authored by regulatory officials of the U.S. Environmental Protection Agency (EPA), European Commission (EC), and the Organization for Economic Cooperation and Development (OECD). The authors offer their perspectives on possible approaches to maximizing the environmental benefits of nanotechnology and products that contain nanomaterials while minimizing the negative impacts. For the path forward, the regulators recommend that researchers and risk managers work together to develop approaches to limit exposure and identify and address those properties of specific nanomaterial types that appear to be the source of potential hazards or exposures. According to the regulators, industry “should contribute significantly to this work because it best understands the characteristics and performance of the materials it produces, as well as what types of controls (such as personal protective equipment for workers) will function best in particular occupational situations.” In recognition of the possibility to avoid risk before nanomaterials enter the environment, the regulators “support the application of a life cycle perspective and encourage the development of safer-by-design methods and approaches such as green chemistry for sustainable production of chemicals in ways that reduce environmental impact.”

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On December 28, 2010, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010 (H.R. 5116) was presented to President Obama for signature. The bill, as unanimously passed by the Senate on December 17, 2010, does not include reauthorization of the National Nanotechnology Initiative (NNI). The House passed similar legislation on May 28, 2010, by a vote of 262-150. The House bill would have reauthorized the NNI. The Senate version, on the other hand, contains no reference to nanotechnology.

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