I was joined on the panel by Stephen B. Ruddy, PhD of Elan Drug Technologies, George Kimbrell, staff attorney of the International Center for Technology Assessment, and Fionna Mowat, PhD of Exponent. Panel organizer Judi Abbott Curry of Harris Beach, LLC, opened with some brief remarks about nanotechnology and its potential importance to the tort law community.
Dr. Ruddy gave his perspective on the broad diversity of nano-based medicines currently on the market or under development, arguing against a “one-size-fits-all” approach to regulation. Elan has launched four nanotechnology based drug products in the US since 2001. He asserted that FDA’s regulatory review process for new drug products appears adequate for nanotechnology-based drug products such as liposomes, nano emulsions and engineered drug nanoparticles but may need to be evaluated periodically as more complex drug products emerge.
George Kimbrell struck a strongly precautionary tone, which should come as no surprise to people familiar with CTA’s work in nanotechnology. [They have filed a number of petitions to FDA and EPA urging them to interpret their regulatory authority more broadly.] He highlighted nanosilver and nanoscale sunscreen ingredients as products of particular concern and called for more federal funding for environmental, health and safety (EHS) research, faster response by federal agencies charged with regulatory oversight, and a stronger regulatory framework that protects workers, the general public and the environment from the impacts of nanomaterials throughout their lifecycle.
Fionna Mowat, an expert in exposure assessment, presented a case study comparing carbon nanotubes and asbestos. Tort lawyers in particular understand the implications of a material showing asbestos-like behaviors. She reviewed three recent papers comparing multi-walled carbon nanotubes (MWCNTs) to asbestos, two of which were reviewed in an ICON backgrounder published last year.The third paper, published this year, investigated the effect of injecting MWCNTs intrascrotally into rats. After identifying similarities and differences between MWCNTs and asbestos fibers she argued for more research and a more nuanced understanding of the potential exposures to MWCNTs throughout the lifecycle.
I spoke last, focusing my remarks on the information needs assessment workshops ICON has convened over the last two years. I previewed some of the conclusions and recommendations of our most recent workshop on Eco-Responsible Design and Disposal of Engineered Nanomaterials, held in Houston in March 2009. One of the working groups focused their attention on regulatory issues for nanomaterial disposal raising questions about whether nanomaterials can leak out of landfill liners, calling for more research into potential impacts of antimicrobial nanoparticles on waste treatment plants, and policies for dealing with nanomaterials in construction and demolition materials, which are often recycled. More information about the workshop’s conclusions and recommendations is forthcoming when the full report is published. Meanwhile, for those who can't wait another moment, Chemical & Engineering News, who embedded a reporter in the two-day workshop, published a summary of views presented and conclusions drawn.
Despite the lower-than-normal level of attendance (blamed on the economy) the question and answer period was lively and it was clear that this was many people’s first serious introduction to the subject of nanotechnology. It is no exaggeration to say that our panel, with its diversity of viewpoints was an eye-opener for attorneys who represent plaintiffs and defendants alike. Afterwards, Ms. Curry confirmed that the tort community is behind the knowledge curve on nanotechnology and that our session accomplished her goal of beginning to inform them about this emerging topic.