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Recent executive action and anticipated impacts

Companies across industries – from tech to transportation – should be paying careful attention to Friday’s executive action signed by President Obama. Our colleagues at Antitrust Law Source, Jay Levine and Chris Yook, wrote an article discussing the order’s requirements and what we can expect as it is implemented. Check out the article: “Breaking: President Obama’s executive order requires all federal agencies to examine antitrust issues.”

In addition, Jay Levine was interviewed by Martha C. White for NBCnews.com for his thoughts on the subject.  As Jay notes, patent applications may see increased scrutiny – definitively something we will be watching as agencies implement this order. Check out the full story here.

Nanotechnology Law — New 2011 Edition

The new 2011 edition of Nanotechnology Law published by West/Thomson/Reuters is now out.  I update the book every year and the new edition has lots of new stuff.  They make excellent Christmas and Birthday gifts, and are a general cure for insomnia.  All proceeds go to my underprivileged daughters’ college fund.  Everyone should have one (or two). …

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.

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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.” …

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:

  Drukuj Email
NOWOSCI The Nanotechnology Education Act  Pełny artykuł zamieszczony  1 lutego, 2010, w Nanotechnology Law Report przez Robert Oszakiewski : http://www.nanolawreport.com/2010/02/articles/the-nanotechnology-education-act/
06.03.2010.

Streszczenie i tłumaczenie: Ewa Lockard

Końcem stycznia 2010, dwóch kongresmanów amerykańskich: David Wu i Daniel Lipinski, zaproponowali wprowadzenie ustawy (The Nanotechnology Education Act), której celem byłoby stworzenie pogramu dotacji wspomagających wprowadzenie i ulepszenie programów i infrastruktur związanych z nauczaniem nanotechnologii. Dotacje obejmowałyby zarówno szkoły średnie, college, uczelnie jak i nieformalne centra technologiczne. Fundusze byłyby przeznaczone na: zakup sprzętu i oprogramowania, zatrudnienie nauczycieli włącznie ze szkoleniami dla nauczycieli nanotechnologii.

Zmieniony ( 06.03.2010. )
Czytaj całość…

“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…

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 Risk Governance: Current Developments and Future Perspectives”

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.…

“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.

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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.…

“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:

Considerations for Implementation of Manufactured Nanomaterial Policy and Governance, NANOMATERIALS RISKS AND BENEFITS, NATO Science for Peace and Security Series C: Environmental Security, (Igor Linkov and Jeffery Steevens eds., Springer 2008).

 

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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

 

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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.…

Texas In Vivo Study to Indicate No Immediate Adverse Heath Effects From Carbon Nanotubes in Bloodstream

The December 4, 2006 on-line edition of the Proceedings of the National Academy of Sciences is set  to publish findings from a recent in vivo animal study researching the possible health effects of SWCNTs deliberately injected into the bloodstream.  Scientists at Rice University and the University of Texas are said to have found that carbon nanotubes are filtered from the bloodstream by the liver over one hour after injection.  The scientists are also said to have sampled tissue from various locations in the test animals and apparently found SWCNT deposits in the liver, and trace amounts in the kidney — both of which were expected.  Preliminary reports believe the study supports the conclusion that there are no immediate adverse health effects from SWCNTs injected into the bloodstream.  Look for more information about this study in upcoming posts.…

Nanotechnology Law Report: The Week In Review

Ed. note: every Friday (more or less) Nanotechnology Law Report’s David Fischer will look back at the week’s news and analysis of nano related issues.  If you have something you’d like to bring to our attention, email him

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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.…

First EPA Regulation Of Nanotechnology?

Rick Weiss reported in yesterday’s Washington Post that the EPA plans to regulate silver nanomaterials used in consumer products as "germ-killing" agents:

The decision — which will affect the marketing of high-tech odor-destroying shoe liners, food-storage containers, air fresheners, washing machines and a wide range of other products that contain tiny bacteria-killing particles of silver — marks a significant reversal in federal policy. * * *

Under the new determination, first reported on Tuesday by the Daily Environment Report, a Washington publication, and confirmed yesterday by the EPA, any company wishing to sell a product that it claims will kill germs by the release of nanotech silver or related technology will first have to provide scientific evidence that the product does not pose an environmental risk.…

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