Nanotechnology Law, 2010 edition
Here is a bit of shameless self-promotion. The 2010 edition of my book -- "Nanotechnology Law" -- has just been published by West/Thomson/Reuters. You can find it here. Please pass the word.
NanoSafety Consortium for Carbon
Just a quick plug for our new NanoSafety Consortium for Carbon which was recently launched to address potential EHS issues concerning its members' products. You can learn more about the consortium at: www.nanosafetyconsortium.com.
First Nano-Specific Insurance: Lexington Insurance Company Introduces LexNanoShield
To our knowledge, this press release announces the first nano-specific liability insurance coverage available in the United States. Many nano-related businesses have been waiting a long time for a product like this. It will be interesting to see industry reaction.
Lexington Insurance Company Introduces LexNanoShieldSM
March 30, 2010 10:15 AM Eastern Daylight Time
NEW YORK--(EON: Enhanced Online News)--Lexington Insurance Company, a Chartis company, today introduced LexNanoShield, an integrated insurance product and array of risk management services designed for firms whose principal business is manufacturing nanoparticles or nanomaterials, or using them in their processes.
“LexNanoShield can help insureds assess and manage these new nanotechnology exposures.”
For the exposures faced by these pioneering companies, LexNanoShield includes liability coverage that provides protection for general liability, product liability, product pollution legal liability and product recall liability exposures. In addition, first party product recall coverage is available to reimburse expenses incurred if a product containing nanoparticles or nanomaterials is recalled from the market for safety reasons. LexNanoShield also provides insureds with legal, technical and loss control consulting services to help develop, implement and assess nanotechnology-specific risk management programs.
“The enhanced reactivity of materials on the nanoscale has led to sunscreens you can’t see, clothes that don’t wrinkle, and paint coatings that don’t scratch. Because many of these products and others like them are relatively new, they require unique coverage and service,” said Tom McLaughlin, Lexington’s Senior Vice President of Specialty Casualty. “LexNanoShield can help insureds assess and manage these new nanotechnology exposures.”
For more information regarding LexNanoShield, contact Bob Nevin, Product Line Manager, at 617-772-4546 or robert.nevin@chartisinsurance.com, or Tom McLaughlin, Senior Vice President of Lexington’s Specialty Casualty unit, at 617-330-8555 or thomas.mclaughlin@chartisinsurance.com. You can also visit www.lexingtoninsurance.com.
Nanodialog.eu -- Nanotechnology Law Report Reaches Poland
Our friends at Nanodialog.eu will now be publishing summaries of select nanolawreport blogs in Polish. Here's an example:
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"Nanotechnology Law" -- Now Online
Readers may be interested in learning that my 2009 book "Nanotechnology Law" is now online. You can find it on Westlaw as Nanotechnology Law (NANOTECH).
The Westlaw version is very helpful because you can now electronically search for any nano-related legal topic and let your computer do all the work -- it even provides links to the footnotes.
As another shameless plug, "Nanotechnology Law" is the only comprehensive legal text on nanotechnology currently on the market and weighs in at 1006 pages. (All the better reason to use the Westlaw search function).
Finally, I am in the process of updating the book for the 2010 edition. Thus, if there is anything important from 2009 that you would like to see analyzed in the 2010 edition -- please let me know and I will see what I can do.
JCM
Index to New Book -- "Nanotechnology Law"
New Edition of Nanotechnology Law Report
Here is the Summer 2009 edition of Nanotechnology Law Report. The newsletter contains the below-listed articles (and more):
- EPA Issues Significant New Use Rules for Carbon Nanotubes
- Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
- Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
- Are Nano Consumer Products Headed Underground?
- Oversight of Next Generation Nanotechnology
- Regulating Nanotechnologies
- More Interesting Nano-Regulatory Developments
- Nano Tug of War
- Pumpkins & Nanoparticles
- Green Nano
- NanoBiotech 2009
- Take two silver nanoparticles and call me in the morning
- International Approaches to the Regulatory Governance of Nanotechnology
- ETUC Resolution on Nanotechnologies and Nanomaterials
- Private Spending on Nano Exceeds Government Spending
- EMERGNANO Released
Nano Insurance Conference
Chubb Insurance is hosting a one-day nanotechnology insurance conference on October 13, 2009 in North Branch, New Jersey:
"Nanotechnology: What is the Best Safety and Risk Management Approach?"
From the conference website:
"This conference brings together prominent nanotechnology speakers who will review nanotechnology background, health and safety, and potential insurance and liability issues. Current risk assessment and 'best practice' controls will be shared, helping attendees better recognize and manage potential nanotechnology risks. A nanotechnology toolkit will be provided to help attendees stay abreast of critical developments in this dynamic field."
Speakers include: Charles Geraci (NIOSH), Charles Kingdollar (General Reinsurance Corp.); John Monica (Porter Wright); Susan Berry (DRS Technologies); Ganesh Skandan (NEI Corp.); William Barr (Chubb); Erik Olsen (Chubb); and Louise Vallee (Chubb).
More from the conference website:
Emerging risks require new risk management practices. Nanotechnology applications have outpaced safety and health research. The big challenge is trying to figure out a risk management roadmap when there is a scientific and regulatory abyss with the potential for future litigation looming in the distance. Companies that delay nanotechnology innovation awaiting safety consensus or regulations risk falling behind the competition. While these tiny materials and processes are big business, many risk managers and insurance buyers haven’t fully considered potential risks to employees, consumers and the environment, resulting in workers compensation, product liability and environmental liability exposures. Company risk managers and insurance buyers would value and benefit from knowledgeable broker and agent guidance. Application and control strategies considered now may have far-reaching future implications.
Nano insurance issues have received a lot of renewed interest lately. This should be a great conference on the topic and is open to the public. Hope to see you there.
"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
"Nanotechnology Law" Published by West/Thomson/Reuters
"Nanotechnology Law" by John Monica was just published this week by West/Thomson/Reuters, the world's leading legal publisher. The book is the first comprehensive legal text on nanotechnology and weighs in at a healthy 900 pages. The table of contents is here. The book is divided into ten informative chapters:
- Nanotechnology Introduction
- National Nanotechnology Initiative and Federal Development Efforts
- Potential Nano-Related Environmental, Health, and Safety Concerns
- Nanotechnology Environmental Regulatory Issues
- Nano-Related Food and Drug Regulatory Issues
- Nanoscale Materials in the Workplace
- Nano-Consumer Products and Insurance Issues
- Municipal, Regional, and State Development and Regulation of Nanotechnology
- Nanotechnology Standards and Nomenclature
- Nano-Intellectual Property Landscape
More information can be found here.
Nanotechnology: Considering the Complex Ethical, Legal, and Societal Issues with the Parameters of Human Performance
"Nanotechnology: Considering the Complex Ethical, Legal, and Societal Issues with the Parameters of Human Performance", by Linda MacDonald and Jeanann S. Boyce and published in Nanoethics 2: 265-275 (2008) (available at http://ieet.org/index.php/IEET/print/2945) is one of the more thought provoking articles that look at the potential impacts of nanotechnology on law and society. It is certainly an ambitious article:
". . . we examine both the positive and negative aspects of the ethical, legal, and societal implications of using nanotechnology for human enhancement"
Human enhancement, for these authors, covers a very broad spectrum, from possible use in the treatment of cancer to "restoring lost functions of limbs, senses and brain function". (Unfortunately, at least for me, that part brings to mind two images, the nanites that appeared in a few late series episodes of Mystery Science Theatre 3000 and the nanoprobes used by the Borg on Star Trek: TNG.
In a suprisingly short section discussing the negative aspects of nanotechnology in general and nanomedicine in particular, the authors do little more than list what they refer to as the perils ranging from "neurnaowarfare" to economic upheaval.
The authors note that other articles have called for baning nanotechnology research and development, but note that this is unlikely to happen for two reasons:
1) "There is far too much money at stake." As someone once noted, money changes everything. Assuming that the economy and Wall Street return to normal, the stocks of nanotech and nanomanufacturing companies might attract the attention and dollars of investors.
2) "Such a ban would push research underground where it could not be regulated".
While noting that "much of the focus in the legal area . . . has been on intellectual property, the preservation of property rights, patent law", the authors turn to a discussion of an extreme possibility - using nano medicine to "enhance" the human body, putting forth the proposition that someone could reach a point where they are no longer totally human. While this might make for an interesting topic in a philosophy seminar or a good science fiction story (you wonder what Philip K. Dick could have done with that idea) it doesnot get a real development in this article.
The authors do make recommendations on how the law should deal with nanotechnology, ranging from a "continuing dialogue" between "lawmakers, scientists, ethicists, economists" to the creation of specialized science courts.
While, as I said earlier, this is a thought provoking article, it suffers from being too short. A longer article or monograph might have allowed for a fuller discussion of the ideas the authors raise. Still, it is worth a read.
"Regulation and Risk Assessment of Nanomaterials -- Too Little, Too Late?"
Steffen Foss Hansen is a Ph.D. candidate at the Technical University of Denmark's Department of Environmental Engineering. Here is a link to his well-written Ph.D. thesis -- "Regulation and Risk Assessment of Nanomaterials -- Too Little, Too Late?"
Dr. Hansen's thesis investigates whether existing environmental, health, and safety regulations and risk assessment techniques are adequate for nanotechnology and provides "some recommendations on how to govern nanotechnologies." While I don't always agree with Dr. Hansen on nano-related EHS issues, there is no doubt that his work is detailed, thorough, and thought provoking. Read it. :)
As an aside, I also had the pleasure of contributing with Dr. Hansen and others on a nanogovernance book chapter this past year which might be of interest to Nanolawreport readers:
Nanotechnology Conference: Food & Drug Law Institute
The Food & Drug Law Institute is holding its 2nd Annual Conference on Nanotechnology Law, Regulation and Policy on February 18-19, 2009 at the L’Enfant Plaza Hotel in Washington, DC. Register here.
Topics include:
- What progress is FDA making in implementing its Nanotechnology Task Force Report?
- What can FDA learn from EPA and other oversight agencies the National Nanotechnology Initiative (NNI)?
- Will the Democratic Congress invest in and/or regulate nanotechnology more than under the Bush Administration?
- Are workers exposed to asbestos-like dangers from dealing with nano products?
- How does a responsible company devise a risk management plan for nanotech
- development — one that takes into account OSHA and NIOSH policy?
- What is reasonable and required federal funding for U.S nanotechnology R&D, including monies for safety and social policy research?
- Are China and Japan ahead of the U.S. in nanotech development?
- For nanotech products and processes, should particle size make a regulatory difference?
PDF of "A Nano-Mesothelioma False Alarm"
Nanotechnology Law and Business was kind enough to let us post a PDF of "A Nano-Mesothelioma False Alarm" here after several readers requested a copy.
Please be sure to visit the journal to see the rest of this issue's articles:
- Grading of Fullerene Nanotubes for Composite Applications
- Next Generation Carbon Fiber
- Patenting Graphene: Opportunities and Challenges
- Oxonica v. Neuftec: Nanoparticle Fuel Additive Litigation in the United Kingdom
- Mediating the Uncertainty and Abstraction of Nanotechnology Promotion and Control: “Late” Lessons from Other “Early Warnings” in History
- The Implications of Recent Nanomaterials Toxicity Studies for the Nanotech Community
- A Nano-Mesothelioma False Alarm
- Convergence of Cleantech and Nanotech and the Benefits to the Nanotech Sector
- French and European Community Law on the Nanometric Forms of Chemical Substances: Questions About How the Law Handles Uncertain Risks
- The Validity of European Nanotechnology Patents in Germany
- Book Review of Nanotechnology & Society: Current and Emerging Ethical Issues
- Top Ten Ways Nanotech Will Impact Cleantech
- Updates
Where Science and Law Meet
The Nano Science and Technology Institute recently published an article, "Where Science and Law Meet," concerning the implications nanotechnology is having on intellectual property law. As one would expect, patents are being filed for nanotechnology products in increasing numbers. Given the complexities of both patent law and nanotechnology, there are unique implications when the two meet. The article provides a good discussion on developments in intellectual property law.
COUNTERPOINT: First EPA Regulation of Nanotechnology?
JCM: My reading is EPA's new position on Samsung's washing machine has little to do with the alleged "nanoness" of the silver ion particles released by the machine. Rather, EPA is focused on the claimed antimicrobial properties of the material. Whether or not the silver ions are truly "nano" is not determinative. Under EPA's current thinking they would still be subject to FIFRA even if they were/are "full sized." Further, EPA has not even determined whether or not the washing machine truly uses nanotechnology, and has stated that such a finding is unnecessary for its ruling. Finally, EPA has made it clear that it evaluates all products on a case-by-case basis, and appears reluctant to make a categorical statement about all products containing nano-silver. Thus, while EPA's upcoming notice to be published in the Federal Register will be of great interest, my guess is that it will not use the Samsung issue as a reason for treating nanomaterials any differently from the way it treats other microbial killing materials.
