New Edition of NanoLawReport
Here is the Summer 2010 edition of NanoLawReport. Heading out to the beach for a few days to top off the summer. :)
European Parliament Members Vote for Ban on Nanomaterials, Including Nanosilver and Carbon Nanotubes
The Members of the European Union’s (“EU”) Environment Committee (“MEPs”) recently voted in favor of proposed amendments to the EU’s Restriction of Hazardous Substances Directive, first passed in 2002, banning the use of nanosilver and long multi-walled carbon nanotubes in electrical and electronic products. The legislators also approved language requiring that any electrical or electronic materials containing nanomaterials should be labeled as such and that manufacturers who use nanomaterials would be required to provide the European Commission with safety data on any materials used. Commentators have noted that the MEPs’ definition of nanomaterials is unclear and the current interpretation could require labeling for every electronic product, such as every transistor in a computer chip. A vote on the proposal is expected in October.
European Parliament votes on measure to regulate food nanotechnology
Members of the European Parliament’s environment, public health and food safety committee have voted to control the use of nanotechnologies in foods for humans. The proposed measure entirely excluded entry onto European Union (“EU”) markets of any food derived from cloned animals as well as food produced by nanotechnology processes, unless such food has undergone a specific risk assessment regarding possible impact on health. Those risk assessment methods must also have been approved for use, i.e., not imply the use of vertebrate animals for testing. The measure also required all ingredients containing nanomaterials to be clearly labeled by listing the names of the ingredients followed by the word 'nano' in brackets. A definition of nanomaterials was included in the proposed text as: “nanomaterial means an intentionally manufactured material with one or more external dimensions or an internal structure, of order of 100 nm or less.” The new regulation can only be adopted after co-decision by both the European Parliament and Members States and must be endorsed by the whole parliament in July.
"Nano Risk Governance: Current Developments and Future Perspectives"
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Nanotechnology Law & Business just published its new edition. For those who might be interested, Volume 6.2 contains an article I co-authored with several nano-friends entitled: "Nano Risk Governance: Current Developments and Future Perspectives." You can find the article here. An abstract follows.
As with many new technologies, developing a framework for making risk management decisions for nanotechnology is a challenge. Risk assessment has been proposed as the foundation for many regulatory frameworks for nanomaterials. Although the traditional risk assessment paradigm successfully used by the scientific community since the early 1980s may be generally applicable, its application to nanotechnology requires a significant information base. The authors’ experience supporting federal agencies in the United States, Canada, and the European Union—as well as state agencies in Massachusetts and New York and cities such as Berkeley and Cambridge—suggests that nanomaterial regulatory frameworks could be built upon existing regulatory approaches with the addition of a more rigorous and transparent method for integrating technical information and expert judgment. The authors argue that the current focus on studying the amount of risk acceptable for a specific technology or material should be shifted toward comparative assessment of available alternatives, and the use of science and policy to identify alternative nanotechnologies and opportunities for risk reduction and innovation. This approach involves the use of both quantitative and qualitative decision analysis tools, offering roadmaps for assessing different information sources and making policy decisions. Two representative methods presented are the Alternatives Assessment method and the Multi-Criteria Decision Analysis method.
Igor Linkov, U.S. Army
F. Kyle Satterstrom, Harvard University
John C. Monica Jr., Porter Wright Morris & Arthur LLP
Steffen Foss Hansen, Technical University of Denmark
Thomas A. Davis, University of Montreal
EC Official Urges International Cooperation
According to a FDAnews Device Daily Bulletin dated October 30, 2006, Philippe Martin, principal administrator for the EC’s nanotechnology and policy efforts, recently advocated international cooperation and self-regulation in the world-wide nanotechnology industry. Martin was quoted as saying that the “U.S. industry’s ‘catch me if you can’ approach to dealing with regulators is not useful.”
I am sure U.S. industry takes issue with Martin's characterization of its self-regulation efforts.
For proposed international approach to nanotechnology regulation see: (1) Abbott, Kenneth W., Gopalan, Sandeep, Marchant, Gary E. and Sylvester, Douglas J., "International Regulatory Regimes for Nanotechnology" (June 8, 2006); (2) Sylvester, Douglas J., Abbott, Kenneth W. and Marchant, Gary E., "A Framework Convention for Nanotechnology?" (August 21, 2006); and (3) Marchant, Gary E. and Sylvester, Douglas J., "Transnational Models for Regulation of Nanotechnology" Journal of Law, Medicine and Ethics, Forthcoming .
