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

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 November 11, 2009, the European Commission (EC) began a public consultation to receive input from all people and organizations involved or interested in nanosciences and nanotechnologies research in Europe, including researchers, policy makers, industry, media, and civil society organizations. The EC adopted on February 7, 2008, a Recommendation for a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, followed on September 26, 2008, by Council Conclusions on Responsible Nanosciences and Nanotechnologies. Both documents suggested that the EC Recommendation and Code of Conduct should be revised after two years. The EC intends to make these revisions in February 2010, and states that the results of the consultation will contribute to that. The Code of Conduct is intended to frame future research development within a set of general principles on which member states are invited to take concrete action to ensure that nanotechnologies are developed in a safe manner. The online consultation ends on January 3, 2010.

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On November 9, 2009, Australia announced the availability of a public discussion paper proposing to strengthen regulation of industrial nanomaterials used in Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) developed the proposal in conjunction with its Nanotechnology Advisory Group, which includes representatives from industry, the community, and research sectors. Major regulatory reforms would include:  refinement of pre-market assessment categories for nanoforms of new chemicals, particularly where human health or environmental exposure can reasonably be anticipated; and a mandatory notification and assessment program for nanoforms of existing chemicals. The discussion paper contains a questionnaire and survey intended to encourage written submissions. Comments are due December 23, 2009.

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On November 10, 2009, the Project on Emerging Nanotechnologies (PEN) released findNano, an application for Apple’s iPhone and iPod Touch that is intended to let users determine whether consumer products are nanotechnology-enabled. According to PEN, the application allows users to browse an inventory of more than 1,000 nanotechnology-enabled consumer products, from sporting goods to food products and electronics to toys, using the iPhone and iPod Touch.  Using the built-in camera, iPhone users can even submit new nanotech products to be included in future inventory updates.

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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 November 6, 2009, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances that were the subject of premanufacture notices (PMN). EPA identified the substances generically as multi-walled carbon nanotubes and single-walled carbon nanotubes. According to the notice, these substances are subject to TSCA Section 5(e) consent orders issued by EPA. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs are based on and consistent with the provisions in the underlying consent orders, and designate as a significant new use the absence of the protective measures required in the corresponding consent orders. Persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use would be required by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due December 7, 2009.

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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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The U.S. Environmental Protection Agency (EPA) has announced that it will stream its November 3-6, 2009, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting on the Internet. EPA has asked the SAP “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under FIFRA have approached the Office of Pesticide Programs (OPP) seeking product registration. OPP believes, based on its understanding of the scientific literature, that pesticides containing nanoscale materials may pose different risks to humans and the environment than those of pesticides that do not contain nanomaterials.

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