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

On May 9, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a significant new use rule (SNUR) for premanufacture notice (PMN) substance P-12-44, which is identified as “functionalized multi-walled carbon nanotubes.” According to the Federal Register notice, “[t]he PMN states that the generic (non-confidential) use of the substance is as an additive for rubber and batteries.” EPA states that it determined that “use of the substance other than as described in the PMN; manufacturing, processing, or use in a powder form; or any use of the substance resulting in surface water releases may cause serious health effects or significant adverse environmental effects.” EPA believes the results of the following tests would help characterize the health and environmental effects of the PMN substance: (1) A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to three months, bronchoalveolar lavage fluid analysis, particle size distribution information and other toxicologically relevant properties, data on histopathology of pulmonary and ex-pulmonary organs/tissues (cardiovascular, central nervous system, liver, kidney, etc.), pulmonary deposition (lung burden), clearance half-life (biopersistence) and translocation of the test material, and a determination of cardiovascular toxicity; (2) analysis by Scanning Transmission Electron Microscopy, Transmission Electron Microscopy, or Scanning Electron Microscopy of number of walls (range and average), tube ends (open, capped, circular, other), tube width/diameter (measure inner and outer diameters or range), tube length (range) including a description of any deformities found in the tubes (bumps, branching, gaps, etc.); (3) percent (range) of functional groups found on the tubes (include the method of determination); and (4) particle size determined by count not by weight or volume (preferably using Scanning Transmission Electron Microscopy). The rule is effective on July 8, 2013.

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The Ministry of Ecology, Sustainable Development and Energy recently announced that it has extended the deadline for declaring substances with nanoparticle status to June 30, 2013. According to the Ministry, it received 1,991 declarations from 457 companies by the original deadline of April 30, 2013. The Ministry states that, given the “diversity of actors covered by the declaration requirement, and at the request of several industries,” for the first reporting year, it will grant a two-month extension.

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On April 15, 2013, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) and NanoQuébec announced they will jointly fund three new research projects on worker exposure to engineered nanoparticles. The principal researchers for these projects, their affiliations, and the titles of the projects selected are:

• Nathalie Tufenkji, McGill University, “Measuring the Effectiveness of Protective Gloves for Working with Nanoparticles in Conditions Simulating their Use in the Workplace”;
• Maximilian Debia, Université de Montréal, “The Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces”; and
• Karim Maghni, Université de Montréal, “The Development and Validation of Universal NanoBadge prototypes (u-Nanobadge) for Evaluating Pulmonary and Cutaneous Exposure to Engineered Nanoparticles.”

According to IRSST, the projects will likely take two years to complete and will involve collaborators from various institutions, as well as students.

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On May 15, 2013, Lynn L. Bergeson will participate in a U.S. Department of Defense (DOD) webinar on “Sustainable Chemicals and Materials for Defense Forum.” Bergeson will provide an overview of the U.S. Environmental Protection Agency’s (EPA) proposed significant new use rules for carbon nanomaterials and biobased chemicals/new chemical exposure limits. The webinar is open to interested stakeholders, who should contact Joey Skoloda for more information.

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On April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled “Building Blocks for Completing EU Regulation of Nanomaterials.” The conference was intended to identify areas where current European Union (EU) legislation on nanomaterials is insufficient. Participants include representatives from Member States, the European Commission (EC), European Parliament (EP), industry, and a number of non-governmental organizations. According to the April 29, 2013, Chairman’s Report, during the meeting, many participants “considered that databases or registries will be indispensable for gathering the necessary information on (products with) nanomaterials.” While France has already created a national registry, and other Member States, such as Denmark and Belgium, have taken steps towards creating their own, participants “agreed that a[n] EU-registration on nanomaterials is preferred over a series of varying national databases,” which could “create[] more problems than solutions in improving a harmonised European policy on nanomaterials.” The Chairman’s Report states that an EC official noted that “the main problem on the table is to define the level of information on nanomaterials that is required.” According to the Report, the current EC “(which will be in office until the second half of 2014) is unlikely to take a decision on setting up a community-wide EU-database for (products with) nanomaterials.” Industry participants acknowledged that an EU-wide registry could increase public confidence in the safety of nanomaterials, but expressed their concern that a registry could also stigmatize nanoproducts and increase the costs for small- and medium-sized enterprises. The Majority Agreements states: “There is a need to further discuss the goals, costs/benefits and outcome of a register of (products with) nanomaterials. Such discussion should address:

• Public concern;
• Consumers choice;
• Traceability;
• Information (for authorities, in the supply chain, for consumers); and
• Proportionality, etc.

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On April 30, 2013, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) announced the availability of the final report entitled Application of Life-Cycle Assessment to Nanoscale Technology: Lithium-ion Batteries for Electric Vehicles. The life-cycle assessment (LCA) was conducted by the DfE/Office of Research and Development (ORD) Li-ion Batteries and Nanotechnology Partnership. The Partnership conducted a screening-level LCA of currently manufactured lithium-ion (Li-ion) battery technologies for electric vehicles, and a next generation battery component that uses single-walled carbon nanotube technology. EPA states that the study demonstrates how the life-cycle impacts of an emerging technology and novel application of nanomaterials (i.e., the single-walled carbon nanotube technology anode) can be assessed before the technology is mature, and provides a benchmark for future LCAs of this technology. The final report’s key results and conclusions state: “In addition, the SWCNT nanotechnology applications assessed show promise for improving the energy density and ultimate performance of the Li-ion batteries in vehicles. However, the energy needed to produce these anodes in these early stages of development is significant (i.e., may outweigh potential energy efficiency benefits in the use stage). Over time, if researchers focus on reducing the energy intensity of the manufacturing process before commercialization, the overall environmental profile of the technology has the potential to improve dramatically.”

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An April 26, 2013, USA Today article entitled “CDC sets carbon nanotech safety guidelines” reports on the National Institute of Occupational Safety and Health (NIOSH) Current Intelligence Bulletin (CIB) 65, Occupational Exposure to Carbon Nanotubes and Nanofibers.  The article includes comments from Andrew Maynard, Chair of Environmental Health Sciences at the University of Michigan,  Todd Kuiken with the Project on Emerging Nanotechnologies at the Woodrow Wilson Center for International Scholars, and Lynn L. Bergeson, Managing Director of Bergeson & Campbell, P.C. and a board member of the NanoBusiness Commercialization Association.

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On April 24, 2013, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, which includes a proposed recommended exposure limit (REL) that is significantly lower than that in the 2010 draft. NIOSH issues Current Intelligence Bulletins (CIB) to disseminate new scientific information about occupational hazards. CIB 65 reviews animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of carbon nanotubes and carbon nanofibers; provides a quantitative risk assessment based on animal dose-response data; proposes a REL of 1.0 microgram per cubic meter (µg/m³) of elemental carbon as a respirable mass 8-hour time-weighted average concentration; and describes strategies for controlling workplace exposures and implementing a medical surveillance program. NIOSH notes that in the 2010 draft of this CIB, it indicated that “risks could occur with exposures less than 1 μg/m³ but that the analytic limit of quantification was 7 μg/m³.” Based on subsequent improvements in sampling and analytic methods, NIOSH states that, in the final CIB, it is now recommending an exposure limit at the current analytical limit of quantification of 1 μg/m³. According to NIOSH, the REL “is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of [carbon nanotubes] may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.” NIOSH notes that, just prior to the release of CIB 65, it reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes. NIOSH states that the results of the study indicate that multi-walled carbon nanotubes can increase the risk of cancer in mice exposed to a known carcinogen. According to the CIB, NIOSH is conducting additional research to learn more about worker exposures and the potential occupational health risks associated with exposure to multi-walled carbon nanotubes and other types of carbon nanotubes and carbon nanofibers. NIOSH states that, as results from its research become available, it will reassess its recommendations and make appropriate revisions as needed.

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The National Research Council (NRC) announced on April 23, 2013, that its second triennial review of the National Nanotechnology Initiative (NNI) identified five “cross-cutting, high-priority areas for focus and improvement for NNI going forward”:

• Improve information gathering and communication at the project level;
• Develop and implement interagency plans for focused areas;
• Rework the NNI website to serve better the diversity of stakeholder groups;
• Take advantage of new technologies for data collection and analysis; and
• Identify, share, and implement best practices, especially relating to technology transfer and commercialization.

In its report, the NRC assesses NNI’s role in maximizing opportunities to transfer selected technologies to the private sector and suggests improvements and new mechanisms intended to foster technology transfer. The NRC evaluates the suitability of current procedures and criteria to determine progress toward NNI goals, and recommends “explicit definitions of success for and metrics associated with meeting those goals.” The NRC also reviews the NNI’s management and coordination of nanotechnology research across participating federal agencies.

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