ten individuals with substantial expertise in environmental, health and safety issues related to engineered nanomaterials. We expect these individuals to play leading roles in nanotechnology law and business.
I am pleased to report that five out of the ten experts listed participate on ICON's steering or executive committee.
BUILDING A BETTER MOUSETRAP: PATENTING BIOTECHNOLOGY IN THE EUROPEAN COMMUNITYVicki Colvin (Rice University), Barbara Karn (US EPA), Kristen Kulinowski (me, Rice University), Andrew Maynard (Project on Emerging Nanotechnologies), and Mary Beth Miller (Unidym).
Thanks to all these experts for their contributions to ICON and the wider NanoEHS community. And thanks to Matthew Jaffe for sending this news along.
I spent a lovely weekend in Phoenix recently, courtesy of the American Bar Association's 18th Annual Spring Continuing Legal Education meeting. The theme of the Tort Trial & Insurance Practice Section's CLE this year was It's a Small World After All: From nanotechnology to global warming--A quantum leap from buckyballs to carbon footprints. (Nothing nano about that meeting title!)
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.
Yesterday, the US Environmental Protection Agency (EPA) held a public meeting on its proposal for a voluntary Nanoscale Materials Stewardship Program. More information on the NMSP can be found here.
After brief introductory remarks by several EPA officials on the nature of the program and the purpose of the public meeting, comments were delivered by the following people. Public comments will be accepted by EPA through September 10, 2007. I have included links to statements that I could find in advance of this deadline.
Shaun Clancy, DeGussa on behalf of the American Chemistry Council
Richard Denison, Environmental Defense [statement]
Bernard Made, Environment Canada
Carolyn Nunley Cairns, Consumers Union [statement]
Scott Slaughter, The Center for Regulatory Effectiveness
James Cooper, Synthetic Organic Chemical Manufacturers Association
Igor Linkov, Intertox, Inc.
Kristen Kulinowski, International Council on Nanotechnology (ICON) [statement]
Sean Murdock, NanoBusiness Alliance
In general, it's fair to say that the NMSP has generated a good deal of debate on both sides. ICON issued a statement calling for EPA to develop a publicly accessible database of information it collects on nanoscale materials, whether in a voluntary or mandatory capacity, and to participate in the development of consensus standards in terminology, methodology and characterization and encourage data submitters to conform to those standards.
The three trade associations that spoke (ACC, SOCMA and NbA) were largely positive about the program, finding it a reasonable approach to generating much needed data on nano EHS, and urging EPA to develop a specific timeline for submission of data and to protect confidential business information that is the lifeblood of many nanotech start-ups.
The two NGOs (Environmental Defense and Consumers Union) and a rep from the Woodrow Wilson Center were critical of the program. Common themes were that this is no good substitute for regulation and that EPA's failure to identify nanomaterials as "new" or to address their newness through the use of the Significant New Use Rule (SNUR) leaves this whole class of materials subject to no pre-market review.
Moreover, these groups are skeptical of the level of participation the NMSP will draw, given the small number of companies participating in the UK's voluntary program. While not able to make public commitments to participate on behalf of their member companies, the trade association representatives noted that, unlike the US EPA, the UK did not have in place a familiar mechanism for dealing with CBI, which may be the causative factor for their low participation.
Stay tuned for more comment and reaction to the program as the deadline for comments approaches. Meanwhile, EPA confirmed that it will hold a peer consultation on nanomaterial characterization needs for the NMSP on September 6-7, 2007 in Rosslyn, VA. This will provide a forum for exploring what types of data characteristics should be reported by participants of the NMSP.
The International Council on Nanotechnology is a multistakeholder forum for developing and communicating information about nanomaterial risk. Please visit us at http://icon.rice.edu.
