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

The Manual states:

Nanomaterials are covered under the substance definition in REACH and may be considered to be distinct substances or forms of a substance (CA/59/2008). The sole purpose of this document is to provide registrants with information on how to technically prepare their IUCLID dossiers for nanomaterials. It is the responsibility of the registrant to identify the substance and this document does not provide any information that will aid the registrant deciding when a nanomaterial can be considered to be a distinct substance or a nanoform. Moreover, following the technical advice given in this document does not imply that a dossier would be compliant with REACH requirements should it be selected for evaluation.

The Manual notes that, although there are no specific information requirements for nanomaterials under REACH, it encourages registrants “to include any information they consider relevant to better describe the substance and to demonstrate its safe use.” The Manual suggests that registrants take advantage of the preliminary guidance of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) on testing, exposure measurements, and mitigation of nanomaterials.

The PEN meeting included two panels. The first consisted of David Rejeski, Director, PEN; Leslie Carothers, President, ELI; Linda Breggin, Senior Attorney, ELI; Robert Falkner, Senior Lecturer in International Relations, LSE; and John Pendergrass, Senior Attorney, ELI. The second panel included Andrew Maynard, Chief Science Advisor, PEN; Mitchell Cheeseman, Acting Director, Office of Food Additive Safety, Food and Drug Administration; J. Clarence Davies, Senior Advisor, PEN; Richard A. Denison, Senior Scientist, Environmental Defense Fund; Astrid Koch, Science and Technology Section, European Commission; and William Gulledge, American Chemistry Council. The slides include the following policy recommendations in key issue areas:

• Creating scientific building blocks for risk assessment:
  • Invest more political energy in the international process, especially the Organization for Economic Cooperation and Development (OECD); and
  • Enhance OECD’s transparency and participation by stakeholders.
• Closing knowledge gaps:
  • Significant increase in funding for environmental, health, and safety research; international coordination of research strategies; and
  • Create mandatory reporting requirement for nanomaterials in commercial use.
• Risk management/labeling:
  • Stronger focus on coordination in area of risk management; and
  • Consider implications of potentially diverging labeling regimes; promote development of common approaches.
• Strengthening global nanomaterials governance:
  • Create international governance capacity in other areas (e.g. United Nations Environment Programme, World Health Organization); and
  • Ensure that developing countries are more involved in international decision-making.

• Shvedova, et al., “Inhalation Versus Aspiration of Single Walled Carbon Nanotubes in C57BL/6 Mice: Inflammation, Fibrosis, Oxidative Stress and Mutagenesis” -- Mice that inhaled carbon nanotubes from an aerosol suspended in the air showed the same dose-related effects as mice that were exposed in past studies through a different method, the direct aspiration of carbon nanotubes into the lung.  Effects included the formation of granulomas in the lungs of exposed mice, and lung tissue fibrosis.  Due to the lack of workplace exposure data, scientists are unable at present to predict whether workers would experience similar effects through workplace exposures, or whether the effects would signal a risk for impairment or death, either in and of themselves or as precursors to other effects.
• Rengasamy, et al., “Filtration Performance of NIOSH-Approved N95 and P100 Filtering Facepiece Respirators Against 4 to 30 Nanometer-Size Nanoparticles” -- Evaluations of NIOSH-approved N95 and P100 filtering-facepiece respirators for reducing exposures to nanometer-sized silver aerosol particles supported previous studies that found that such respirators should provide expected levels of protection against nanoparticles, when fitted, maintained, and used properly.
• The International Alliance for NanoEHS Harmonization (IANH) -- Four NIOSH researchers representing combined interdisciplinary expertise in laboratory and field studies are part of IANH, a new international research partnership.  IANH intends to establish scientific protocols to promote harmonization in the toxicological testing of nanomaterials.
• Organization for Economic Cooperation and Development (OECD) Workshop -- NIOSH is leading the formation of an October 20, 2008, workshop on the assessment and mitigation of workplace exposures to nanomaterials.  During the workshop, representatives of the OECD Working Party on Manufactured Nanomaterials and invited outside experts will explore the latest developments, needs, and opportunities in research.
• The Richard C. Knudson Publication Award, 2008 -- The American Biological Safety Association presented this award to Vladimir V. Murashov, Ph.D., Special Assistant to the Director, NIOSH, and John Howard, M.D., former Director of NIOSH, for the paper “Biosafety, Occupational Health, and Nanotechnology.”  The award recognizes “significant contributions in areas of scientific investigation and/or health and safety.”

The General Summary states:

It is the opinion of the working group that research, development and application of nanotechnology are covered by existing legislation.  In view of this, the working party does not consider there to be a need for special nano-legislation.

However, the working group also considers that there will continue to be a need, determined by future development, to assess and if necessary adapt rules and executive orders etc. within the framework of existing legislation. Work is in progress in a number of national and international forums to create the necessary conditions for such adaptation, in part by establishing standards and limit values.

The [European Union (EU)] and the [Organization for Economic Cooperation and Development (OECD)] are playing a key role in connection with risk assessment of nanotechnology, in part through the EU’s [Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and Scientific Committee on Consumer Products (SCCP)].  It is therefore important to keep an eye out for recommendations and assessments issued by the EU and the OECD, as it will be possible to use these actively in connection with the adjustment of Danish rules and executive orders.

The potential risks and opportunities, according to Lloyd’s, include:

1. A Potentially Large Market: One estimate by the Lux Research says that 15% (by value) of all products will contain nanotechnology by 2014. Currently most nanotechnology products are found in the sports, household and food industry, though others are using them to a growing extent. This is a rapidly growing and potentially large future market.
2. Nanoparticles, Different Material Properties: Nanoparticles can be much more reactive than larger volumes of the same substance. Such particles often have unknown toxicity which can be difficult to quantify. They can disperse easily in air or water. Researchers believe this form of nanotechnology is the most risky at present and the insurance industry should monitor developments in this field closely.
3. Unknown Impacts on Health: It is unclear whether nanoparticles can cause chronic health effects. Studies are still speculative, but insurers would be prudent to consider adverse scenarios when agreeing to terms and conditions, and when determining pricing and capital. In particular, whether a claims made trigger as opposed to an occurrence trigger is appropriate, and whether limits should have an aggregate limitation.
4. Unknown Impacts on the Environment: There is still too little research into the potential negative impacts of this technology on the environment. Given the large pollution losses faced by the insurance industry in the past, this is cause for concern although there are now many exclusions in place to limit such losses. As for health impacts, where there is cover, insurers may want to consider the terms and conditions carefully and whether to exclude losses due to the reduction of property values.
5. Many Positive Effects: Nanotechnology could also bring direct benefits to risk mitigation in the form of new materials that are stronger or more adaptive than before. Cars could be made to absorb more of the impact during a crash; building materials could be made stronger and more flexible to resist damage from earthquakes, fire, flood, and corrosion. Environmental clean-up operations could be made easier and cheaper with the use of specialised nanoparticles. Medicine could be transformed by nanotechnology, allowing cheaper and more sensitive diagnostic tools for diseases, giving insurance professionals better statistics to determine pricing. Because the benefits are so “seductive,” however, society may rush to capitalise on them before adequately assessing safety. The insurance industry must ensure that its own financial health is not compromised by systemic aggregations of loss from these technologies.
6. Lack of Regulation: Currently almost all regulation of nanotechnology is done using existing mechanisms. The “wait and see” approach is increasingly becoming a dangerous way to determine the risks. There is progress in this area, and the Organization for Economic Cooperation and Development (OECD) has released a “Nano Risk Framework,” which provides a framework for risk managers to address this. The precautionary principle is now accepted to apply to the degradation of human health as well as the environment, and suggests the use of this technology should be risk assessed appropriately before consumption by the public. This approach is being recommended within the European Union (EU), though the U.S. and Japan “prefer a lighter regulatory touch.” In the past, a vacuum of regulation has proved unhelpful to insurers. The insurance industry should lobby for clarity in this area.

The report includes the following recommendations for government regulators:

• The Swedish Governmental Agency for Innovation Systems (VINNOVA) should draw up a strategy for nanotechnology research and development, which includes knowledge about risks to human health and the environment;
• Special research funds should be allocated for the Swedish Research Council for Environment, Agricultural Sciences, and Spatial Planning (Formas) for research about the health and environmental risks of nanomaterials;
• KemI should follow developments in the area and propose measures whenever it is justified, and participate actively in the development of new or modified testing methods within the Organization for Economic Cooperation and Development (OECD) cooperative framework;
• KemI should produce a deeper analysis of the use of nanomaterials in chemical products and articles, after consultation with the trade organizations concerned;
• Instruct the governmental agencies concerned to review the need for complementing existing legislation; and
• Arrange, in the context of Sweden’s European Union (EU) presidency in 2009, a workshop on how the health and environmental risks of nanotechnology should be addressed by legislation.