Risk Management/Risk Governance

 

read more

Research by scientists at the University of Bath (UK) is challenging claims that nanoparticles in medicated and cosmetic creams are able to transport and deliver active ingredients deep inside the skin.

The Bath study, published in the August 20, 2012, issue of the Journal of Controlled Release, found that even the smallest of nanoparticles tested did not penetrate the skin’s surface.

These findings have implications for pharmaceutical researchers and cosmetic companies that design skin creams with nanoparticles that are supposed to transport ingredients to the deeper layers of the skin.  The efficacy of those products may have to be reconsidered. 

From a safety and risk standpoint the findings are significant because they allay concerns that potentially harmful nanoparticles such as those used in sunscreens (e.g. titanium dioxide) can actually be absorbed into the body through dermal exposure.

read more

You may be interested in a recent article in Product Liability Law360, February 2, 2012: "Mitigating Risk in Mass Nano Torts."

 

The article by attorneys Michael Lisak and James Mizgala (Sidley Austin LLP) suggests that consumer fraud (no-injury) class action claims are likely to be some of the first nanotechnology-related lawsuit faced by comapnaies making or selling nanomaterial-containing products. They suggest that the BPA plastic products liability class-action litigation can provide a useful framework for how similar nanoparticle claims may be pursued and defended.

Some excerpts are provided below, so you can decide whether to obtain the full article.

read more

The January 2012 issue of the Defense Research Institute’s For The Defense magazine features the nanotechnology article "A Litigator's Guide to Health and Environmental Issues," by attorney John Delany, a member of Delany & O'Brien, in Philadelphia.

Delany describes the potential for what is now a limited series of commercial, patent, and regulatory legal battles to become full-blown personal injury tort litigation in the near future. Here is an excerpt:

The factors that could create a toxic, nanolitigation storm are (1) ubiquitous exposure; (2) sympathetic plaintiffs; (3) sensational press (4) reactive politicians; (5) product identification capability pointing to a specific product or a specific defendant; (5) biomarker and causation evidence; (6) corporate culpability; (7) state-of-the art medical and liability; (8) the serious, objective, potentially permanent nature of a potential injury due to nanomaterial exposure compared with potentially subjective transitory injury; (9) deep pockets of recovery; (10) product benefit-cost utility; and (11) warnings and personal choices involved with exposure.

In addition, judicial and legislative factors may affect the liability picture, including potential immunities, economic caps, limitations on punitive damages, joint and several liability, the collateral source rule, venue shopping, removal to a federal court, preemption, and the framework that the judiciary uses to manage and adjudicate claims, such as multi-district litigation processes.

 

read more

A project funded by the Danish Environmental Protection Agency (EPA), has resulted in the development of a new nanomaterial risk assessment tool called NanoRiskCat (NRC). The project's aim was to identify, categorize, and rank exposures and effects of nanomaterials used in consumer and industrial products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers, as well as nanomaterials released into the environment. The tool is a valuable step but needs to be further validated and tested on a series of various nano products in order to adjust and optimize the concept.

The project report, NanoRiskCat - A Conceptual Decision Support Tool for Nanomaterials, is 268-pages long.  I've provided what I hope is a succinct, but still sufficiently robust, summary of the NRC project and report below, from the report's Executive Summary. 

read more

     

The Innovation Society and Marsh Risk Consulting will be holding a free webinar (English language), “Managing Nano Risk – Implementation of a Risk Management System for Nanomaterials,” on February 23, 2012.

For a company with a connection to nanomaterials, and its insurers, it is difficult to judge whether there are hidden risks to workers or customers due to uncertainty in health, safety and environmental (HSE) data. Furthermore it is difficult for a company to anticipate the future development in nanomaterials regulation globally. The webinar aims to provide useful information about those issues.

read more

The legal battle has finally been joined.  The first lawsuit over the health and environmental risks of nanotechnology and nanomaterials has been filed.

On December 21, 2011, a coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the United States District Court for the Northern District of California. International Center for Technology Assessment, et al v Margaret A. Hamburg, M.D., Case No. CV 11-6592, is an Administrative Procedure Act case seeking declaratory and injunctive relief. The Plaintiffs (ICTA; Friends of the Earth; The Action Group on Erosion, Technology and Concentration; The Center for Environmental Health; Food and Water Watch; and the Institute for Agriculture and Trade Policy) demand that the FDA respond to a petition these organizations filed with the agency in 2006.

The eighty-page 2006 Petition documents the groups' claimed scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. The 2006 petition requested FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency. The FDA had yet to act on the 2006 petition, prompting the suit.

read more

You may be interested in an article published by BNA's Product Safety & Liability Reporter in November 2011: "Labeling and Warning for Products Containing Engineered Nanomaterials: Learning From the Past or We Are Doomed to Repeat It"

The article is a very good collaboration by attorneys William Rogers and Joseph Clark (Day Pitney LLP) and scientists Joyce Tsuji, David Dahlstrom, and Steven Arndt (Exponent), and provides guidance about how to approach the new world of labeling, warning, and instruction creation for products containing nanomaterials.

A few excerpts are provided below, to help you decide whether you want to get the full article.

read more

SAFENANO, Europe's Centre of Excellence on Nanotechnology Hazard and Risk, along with the Institute of Occupational Medicine (IOM), have announced the official launch of the European Research project MARINA (MAnaging RIsks of NAnoparticles).

While there are standard procedures for product life cycle analysis, exposure, hazard, and risk assessment for traditional chemicals, it is not yet clear how these procedures need to be modified to address all the novel properties of nanomaterials. There is still an acute need to develop specific reference methods for all the main steps in managing the potential risk of ENM. The aim of MARINA is to develop such methods.

read more

The National Nanotechnology Initiative (NNI)'s latest environmental, health, and safety research strategy, published in October 2011, highlights what has become a risk assessment focus within the world of nano safety: The need to look at the entire impact of an application or product, from the workers who manufacture it to how the consumer uses it to the way it’s disposed of.

read more

 

The United States National Nanotechnology Initiative (NNI) this week released its 2011 NNI Environmental, Health and Safety (EHS) Research Strategy, which provides an integrated research framework meant to guide all federal agencies participating in NNI.

Six core categories of research were identified:

1. Nanomaterial Measurement Infrastructure
2. Human Exposure Assessment
3. Human Health
4. Environment
5. Risk Assessment and Risk Management
6. Informatics and Modeling.

The strategy also aims to address the various ethical, legal, and societal implications of this emerging technology.

The strategy is grounded in the principles of risk assessment and product life cycle analysis, so as to measure risk at every stage of a product’s development, from preliminary handling of raw materials to final disposal of finished products.

read more

 

A recent document from the Organization for Economic Co-operation and Development (OECD), “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” provides an update on current developments and activities regarding the safety of manufactured nanomaterials in OECD member countries, and other delegations that attended the 8th meeting of the OECD’s Working Party on Manufactured Nanomaterials, held in Paris, France from March 16 to 18, 2011. 

 

The document includes written reports on current activities related to nanotechnologies and nanomaterials in other international organizations, such as the International Organization for Standardization, the Food and Agriculture Organization of the United Nations, and the World Health Organization.  This resource is intended to provide delegations and other stakeholders with a “snapshot” (current to March 2011) of information on activities related to manufactured nanomaterials, as well as other nanotechnology activities, at the national and international level.

read more

In a set of recommendations that could have far-reaching implications, the National Institute for Occupational Safety and Health has concluded that airborne super-small particles of titanium dioxide “should be considered a potential occupational carcinogen.”

A recently released NIOSH guidance document (NIOSH, 2011) on handling titanium dioxide (TiO2) powders in the workplace has generated a high level of interest as it puts forward an innovative approach that might have implications beyond TiO2.

The new document outlines the agency’s suggestions for exposure levels that will avoid long-term problems. The bulletin is discussed in some detail at the CDC/NIOSH Science Blog.

 

read more

You may be interested in an article published by BNA's Product Safety & Liability Reporter in April 2011: "Nanotechnology Manufacturers' Duty to Warn and Potential Affirmative Defenses."

The well-written article, by attorneys James W. Mizgala and Michael L. Lisak (Sidley Austin LLP in Chicago), assesses a manufacturer's duty to warn of potential dangers posed by nanomaterials, and then offers suggestions for defenses that could be raised by nanomaterial defendants facing failure to warn claims.

A few excerpts are provided below, to help you decide whether you want to obtain the full article.

read more

"Potential Human Health Risks of Nanomaterials" was published in the March issue of the International Risk Management Institute (IRMI) newsletter.

The article, authored by Gradient Corp.’s Dr. Marc Nascarella and Dr. Barbara Beck, along with Attorney Joseph Clark of Day Pitney LLP, focuses on the potential human health hazards, risks, and liability issues associated with nanomaterial exposure.

The full article is available here, and is excerpted below.

read more

 

SAFETY ISSUES OF NANOMATERIALS ALONG THEIR LIFE CYCLE is a two day Symposium that will be held on May 4-5, 2011, at LEITAT Technological Center, Barcelona (Spain).  It is jointly organized by the coordinators of three European Community nanotechnology safety research projects: NANOPOLYTOX, NEPHH and HINAMOX.  

The aim of the Symposium is to discuss the human and environmental impacts of nanomaterials along their life cycle from their production through their processing, use, and end of life (recycling and/or disposal).   Therefore, the tools and methodologies proposed for the risk assessment (RA) and Life Cycle Assessment (LCA) of nanomaterials will be one of the main topics of discussion in this symposium.

A panel of international experts have been invited as speakers and the lectures will be organized into six different sessions:

Session 1. International, national and regional initiatives on Nanotechnology / Nanosafety
Session 2. Nanomaterials: Synthesis, characterization and applications
Session 3. Human health impact of Nanomaterials
Session 4. Environmental impact of Nanomaterials
Session 5. Risk assessment of Nanomaterials
Session 6. Life cycle assessment of Nanomaterials

read more

This conference on Monday, March 21, 2011, in Phoenix, promises to be interesting.

After several years of studying the risks of nanotechnologies, federal agencies such as EPA, FDA and NIOSH are now moving forward with more aggressive regulation, and a variety of other non-regulatory risk management and safety initiatives have been proposed or implemented.

The 2011 conference will examine recent trends and challenges in regulation and risk management of nanotechnology. Top national and international nanotechnology experts from government, industry, non-governmental organizations, the insurance industry, and academia will be featured.

read more

 

The American Society of Mechanical Engineers (ASME) Nanotechnology Institute has published a new podcast as part of its educational outreach initiative on all aspects of nanotechnology developed by society.

 

The podcast, "Nano Environmental Health & Safety", with Dr. Andrew Maynard, Chair of the University of Michigan Risk Science Center, deals with environmental, health and safety aspects of nanotechnology.

 

Maynard, of course, is one of the most prolific nanorisk speakers and writers, and this latest ASME-sponsored discussion is worthwhile.  

 

The podcast is available via download on a complimentary basis at http://nano.asme.org/, where you can also sign up to be added to the Nanotechnology Institute mailing list to get announcements and information on ASME's Nanotechnology Institute endeavors.

read more

In an article published in the November 11, 2010, issue of Toxics Law Reporter -- Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims --I discuss the prospect of nanoparticle mass tort/class action litigation, the likely claims and defenses, and offer a preview of potential Daubert-style challenges to exposure, dose, and causation experts given the state of science and the law in late 2010.

In a two-part blog article, I have excerpted and condensed that article. In Part 1, on November 14, I discussed the likely mass tort/class action claims. In Part 2 below I discuss the tactics for defeating early mass nanotort claims.

read more

The existence of a large, well-financed mass tort infrastructure makes it likely that plaintiffs’ attorneys will try to exploit the Age of Nanotechnology through mass tort and class actions. Plaintiffs who already have a disease will assert that their diseases were caused by or exacerbated by their exposures to anoparticles. Those without disease will assert a need for medical monitoring.

In an article published in the November 11, 2010, issue of Toxics Law Reporter -- Nanoparticles : New Frontier for Product Liability Mass Torts/Class Action Claims --I discuss the prospect of nanoparticle mass tort/class action litigation, the likely claims and defenses, and offer a preview of potential Daubert-style challenges to exposure, dose, and causation experts given the state of science and the law in late 2010. 

In a two-part blog article, I have excerpted and condensed the article. Here is Part 1.

read more

Nanotechnology is transforming product design and innovation among manufacturers of electronics goods, textiles, cosmetics and foodstuffs as well as in other fields of materials science.  However, for insurers, uncertainty still surrounds the increasing use of nanotechnology in products and how safe they are.

  An October 6, 2010, article by Lloyd's of London, one of the world's largest insurance markets, discusses the concerns.  

  An article in the October 7 on-line edition of Insurance Journal also discusses the Lloyd’s article.

Excerpts from the Lloyd's on-line article, “Regulators get to grips with nanotechnology,” are reproduced below. 

read more

Nanotechnology VI Symposium: “Progress in Protection” is co-sponsored by the California Department of Toxic Substances Control (DTSC) and the University of California Los Angeles’ Center for the Environmental Implications of Nanotechnology (UC-CEIN). The symposium will build on topics discussed at DTSC’s previous nanotechnology symposiums. It also emphasizes occupational safety and health concepts, which are keys to reducing potential risks to workers and the environment from engineered nanomaterials (ENMs).

Discussion topics will include:  

- Collaboration between DTSC’s Office of the Chief Scientist, the National Institute for Occupational Safety and Health (NIOSH) and California’s leading universities to fill data gaps via the development of ENM risk-based guidelines. 

-Practical insights from current nanomaterial manufacturers regarding health and safety.

read more

In Germany the early detection of health risks in consumer-related areas is the responsibility of the Federal Institute for Risk Assessment (BfR). In this context it has developed, together with the Federal Institute for Occupational Safety and Health (BAuA) and the Federal Environmental Agency (UBA), a research strategy to identify the potential risks of nanotechnology. The goal of this research strategy is to structure this research area, to develop methods for the measurement and characterization of nanoparticles, to collect information on exposure, toxicological and eco-toxicological effects, and to promote the development of a risk–based test and evaluation strategy.

When questions about the safety and the potential risks of nanotechnology were becoming increasingly pressing, the BfR in 2006 began to carry out the interdisciplinary research project “Delphi Study on Nanotechnology - Expert Survey of the Use of Nanomaterials in Food and Consumer Products.”  Parts of the study were undertaken in cooperation with the Centre for Interdisciplinary Risk Research and Sustainable Technology Development (ZIRN) of Stuttgart University. The goal of this project was to lay the foundations for future BfR risk assessments of nanotechnology applications.

In September 2010 the results of the BfR Nano Delphi study were published, offering a detailed discussion of each of the basic nanostructured substances currently on the market, as well as across a variety of product uses.   This work is very helpful for those currently tasked with assessing and managing the likely future risks associated with nanomaterial usage.

read more

The Massachusetts Office of Technical Assistance & Technology (OTA) recently prepared a Technology Guidance Document, “Nanotechnology – Considerations for Safe Development”

The OTA is a department of the state’s Executive Office of Energy and Environmental Affairs, and is responsible for helping entities in the state achieve superior environmental, health and safety performance while also improving economic sustainability.

According to the Guidance, “there are indications of potential harm from certain exposures and releases of engineered nanoparticles (ENPs), and it is essential to recognize, reduce and control these risks when they are present.” The Guidance was prepared for “the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment—it will also impede the common interest in realizing the benefits that nanotechnology can provide.”

read more

Cantox, an Intertek Company, is hosting a FREE 1 hour webinar on September 9, 2010 at 2 pm EDT, providing an overview of the health and environmental challenges and opportunities of nanotechnology and nanomaterials. This webinar will be followed by a 10 minute interactive Q&A session, allowing registrants to get answers to their concerns.

For those of you hungry for an opportunity to learn more about the current state of nanomaterial risk, in 1 hour at no cost, this looks like a great opportunity.

DATE: Thursday, September 8, 2010
TIME: 2:00 PM EDT / 1:00 PM CDT / 11:00 AM PDT
DURATION: 1 hour
PRESENTER: Bernadene Magnuson, Ph.D.
Senior Scientific & Regulatory Consultant
TO REGISTER: Click Here

Topics to be addressed:
- Fundamental concepts of science, engineering and technology at the nanoscale level
- How to define and describe nanoscale science and nanotechnology
- Current uses of nanomaterials in consumer products
- Factors and properties of nanomaterials that play a role in potential health effects and environmental impact
- Critical factors to consider in assessing safety of nanomaterials
- Solutions to address challenges and be positioned to capitalize on opportunities

Presenter:
Dr. Bernadene Magnuson
Senior Scientific & Regulatory Consultant
Cantox Health Sciences International, an Intertek Company

Dr. Magnuson is a specialist in the developing field of food nanoscience, and has received international recognition for her research on diet and cancer and her work in food toxicology and food safety. Her academic career in food and nutritional science and technology has included teaching and research appointments at the University of Maryland, the University of Idaho, the University of Saskatchewan, and the University of Manitoba. She also has had private-sector experience in Australia, Canada, and the United States.

Dr. Magnuson has been elected to numerous leadership positions of the Institute of Food Technologists – most recently as a member of the Nanotechnology Working Group – and the Society of Toxicology, and she has been the recipient of outstanding service awards from the FDA and IFT. Her research has been published in over 40 peer-reviewed journal articles and book chapters, and had led to several patents. She is a member of the editorial board of the Journal of Food Protection and an associate editor of Food Analytical Methods.

read more

This is the second in a two-part blog article that provides some practical guidance for chemical organizations, product manufacturers, and risk managers so that good planning can prevent or mitigate future personal injury litigation risk from nanotechnologies.

In Part 1, I outlined some of the basic challenges. Here, I outline some specific action plans.

read more

Over the past two years I have written extensively about some of the potential litigation risks posed by exposure to nanoparticles, and on the evolving response of U.S. government agencies to regulation of nanotechnologies.   

 This two-part blog article takes the next step and aims to provide some practical guidance for chemical organizations, product manufacturers, and risk managers so that good planning can prevent or mitigate future personal injury litigation risk from nanotechnologies.

read more

 

The ASSE’s annual conference, “Safety 2010,” held on June 13-16 in Baltimore, included two presentations about aspects of nanotechnology risk and safety.

1. Nanomaterials: The Good, The Bad and The Ugly
(Leslie C. Caskey, Christopher W. Kolbash)

2. Nanotechnolog-E: Explosivity and Environmental Risks
(Louise E. Vallee, Julia C. Bradley, Erik G. Olsen)

If you are interested, these presentations are available for purchase from the ASSE website. http://www.asse.org/education/pdc10/

I briefly summarize the first presentation below.

read more

Nanotechnology can enhance the flavor and other sensory characteristics of foods, introduce antibacterial nanostructures into food packaging, and encapsulate and deliver nutrients directly into targeted tissues, among other applications. However, as with any new technology, along with the benefits, there is the potential for unanticipated adverse effects.

There is still a great deal to learn about any health outcomes related to introducing nanosized materials into foods and food packaging materials. Developing nanotechnology into a safe, effective tool for use in food science and technology will require addressing these and other questions.

There is a robust debate about the appropriate use of nanotechnologies in the food/agriculture industry when open questions remain about consumer safety, as I observed in Part I of this series of posts on June 3, 2010.

I suggest two additional sources of information for folks interested in the nanotechnology food safety issue:

read more

I recommend that you add to your “nanolinks” for regular reading the NanoLaw Blog, hosted by Widener University Law School.

The NanoLaw Blog Mission Statement: Nanotechnology has been around for a while, but it is becoming more pervasive as new products and applications appear. The National Nanotechnology Initiative lists developing uses as diverse as cancer treatments, nerve regeneration, efficient solar energy, and both industrial and consumer product enhancement. Notwithstanding this burst of technological ingenuity, the impact of nanotechnology on human health and the environment has been only sparsely studied, and nanotechnology is virtually unregulated in the United States. Without information regarding the impacts of nanotechnology, agencies entrusted with making regulatory decisions regarding applications that use the technology – such as OSHA, FDA, and EPA – cannot effectively regulate. As an emerging technology with unknown risks, nanotechnology is likely to follow the path of other toxic torts in the areas of both private law and public law. The purpose of this site is to raise legal questions about the impact of nanotechnology and comment upon the ways in which those questions are likely to be raised in the legal system.

With the permission of the NanoLaw Blog I have below reproduced one of the recent posts, an interesting discussion of the legal significance of early nanomaterial studies of environmental, health and safety. You will find it interesting.

read more

. . . then you simply must start becoming knowledgeable, if not expert, on the uses of nanotechnology in agriculture and food production, food products, food processing, and food packaging. It is going to be a significant growth area and an expected litigation field within the food safety/toxic exposure arena.

I'd suggest you might do a couple things to get started:

read more

 

“Nanotoxicology 2010” will be held from June 2nd – June 4th 2010, at Edinburgh Napier University, Edinburgh, Scotland.

Speakers presenting at Nanotoxicology 2010 are an esteemed international group of highly respected nanotechnology experts from industry, government, and academia in the United States, Canada, Europe, and Asia.

The conference will take place over 3 days, and will be divided into sections that allow focus on specific types of nanomaterials including carbon nanotubes (the most commonly used nanomaterial in industrial applications), nanometals (such as nanosilver, increasingly common in consumer products), and nanometal oxides (such as nano-titanium dioxide and nano-zinc oxide, the nanomaterials most widely used in consumer products currently).

read more

Citing both Canadian and U.S. sources, a recent YouTube-hosted video with the above title was recently posted at the Nanotechnology.org website.

The brief audio/video report (1:17 in length) runs through a number of general media headlines in the past year — such as “U.S. nanotechnology safeguards inadequate” and “Health Canada yet to respond to expert calls for better nanotechnology regulations” — pointing out that “critics warn that not nearly enough is known about how these altered materials might affect the human body and the environment.”

read more

Responding to a recent series of AOL News articles questioning the oversight of nanotechnology product safety, nanoTox™, Inc. COO Greg King said that nano-product companies will need to confront possible negative perceptions directly to avoid the kinds of public outcry experienced by bioengineered food companies in the past.

“It’s in people’s nature to fear the unknown,” said King. “And while companies may not be able to educate everyone in the complexities of nanotechnology, they can turn safety concerns to their advantage by being transparent about its use in their products, documenting their careful research and emphasizing concern over human and environment health.”

King was responding to the recent AOL News Special Report series entitled “The Nanotech Gamble” which explored possible risks that may accompany nanotechnology research and product development.   The series was greeted with concern by most in the U.S. nanoproduct industry.  See my May 12, 2010 post for more about the series. 
read more

Friends,

An online seminar, "Understanding Nanotechnology Safety", will be webcast on May 27, 2010, at 1:00 U.S. EDT and is intended for anyone concerned about the potential health hazards of exposure to nanoengineered materials.

The seminar, sponsored by Small Times (note: Small Times is a leading source of business information and analysis about nanotechnology), will educate about: 

    -  trends in nanotechnology and how it is used in manufacturing;

    -  risks of nanotechnology;

    -  what can happen to the body when exposed to hazardous nanomaterials;

    -  how to minimize the risk of exposure; and

    -  government safety regulation.

Presenters include: Mark Bünger Research Director, Lux Research; Walt Trybula, Director of the Nanomaterials Application Center, Texas State University-San Marcos; Dr. Kristen Kulinowski, Department of Chemistry, Rice University; Nina Horne, Invited Expert; and, Dr. Antonietta M. Gatti Ph.D., Experimental Physics University of Bologna, Italy.

Cost is $129.00 ($99.00 for registration by May 10, 2010). Seminar length is 2 hours.

Registration information can be viewed online at the link below.
http://downloads.pennnet.com/digitalmedia/st/stwebcast2.html

For those of you hungry for an opportunity to learn more about the current state of nanotechnology risk, in a compact 2 hours for a modest fee, this looks like a great opportunity.

read more

On March 30, 2010, the Lexington Insurance Company, Boston, MA, introduced LexNanoShield, an insurance product aimed at those firms whose principal business is manufacturing nanoparticles or nanomaterials, or using such substances in their processes.

Tom McLaughlin, Lexington's Senior Vice President of Specialty Casualty, says "[T]he 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. LexNanoShield can help insureds assess and manage these new nanotechnology exposures." read more

I want to let you know about two books (both available in paperback) that have some good information about nanotechnology risks to health and the environment.  These would be especially helpful for a non-scientist that wants to get a good sense of the general range of risk issues.

1.  Nanotechnology: Consequences for Human Health & the Environment  

Ronald E. Hester (Editor), Roy M. Harrison (Editor)  

2.  What Is Nanotechnology and Why Does It Matter?: From Science to Ethics

F. Allhoff, P. Lin, and D. Moore

read more

SAFENANO recently prepared an article -- SAFENANO Review of 2009 -- detailing some of the key developments in nanotechnology environmental health and safety (EHS) from 2009, and reflecting on what's in store for 2010. read more

Dr. Sally Tinkle, senior science advisor at the United States National Institute of Environmental Health Science, part of the National Institutes of Health, wrote an intriguing article recently, Examining the Holy Grail of Nanotechnology: Safe By Design.

Dr. Tinkle discusses the idea that nanomaterials can be engineered to be Safe by Design (SxD), meaning that they are designed to "maximize their benefit in problem solving and product development while posing minimal risk to human health and the environment."
read more

This is part four of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Generally speaking, nanomaterials pose the same problems to products liability lawyers that macro products do. Manufacturing defect, defective design, and failure to warn are not going away. But nanomaterials do pose some unique problems within each cause of action. Part 4 is an overview of those various problems.

 

read more

This is part three of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management. The author is Nick Dudley, a third-year law student at the University of Minnesota Law School.

Products liability attorneys will face unique challenges from the nanotechnology industry. Part 3 suggests a broader coping strategy. Attorneys and insiders must find a balance between industry-wide security that some regulation would provide, while avoiding the choking effects of over-regulation.
read more

You may be interested in an article published by BNA's Toxics Law Reporter in December 2009:  "Nanotechnology: The Next Battleground for Mass Torts?" 

The article by Scott DeVries and Sarah Jehl, attorneys experienced with environmental mass torts and insurance coverage, offers some potentially useful procedural suggestions for defense attorneys faced with nanotech-focused mass torts.

In particular, the authors tout the possible benefit of so-called "Lone Pine" orders to test the viability of novel nanotechnology-based toxic exposure claims.  "Lone Pine" orders are derived from the case of Lore v. Lone Pine Corp., 1986 N.J. Super. LEXIS 1626 (N.J. Super. Law. Div. Nov. 18, 1986).   Such orders, designed to require plaintiffs to make an objective showing early in litigation that there is sufficient evidentiary basis to warrant continued litigation, have been widely accepted and used in other federal and state courts throughout the country.  To learn more, see Attorney DeVries' article on the subject: S. DeVries, et al., Use of Lone Pine Orders in Cost Effective Management of Mass Tort and Class Actions, 23 Toxics Law Reporter 1003 (Nov. 2008). 

Devries can be contacted at for more information or a copy of his prior article above.

Source: BNA Toxics Law Reporter

 

 

read more

This is part two of four in a primer on nanotechnology and the potential effects it will have on products liability litigation and risk management.  The author is Nick Dudley, a third-year law student at the University of Minnesota Law School. 

Nanotechnology promises to enhance existing technology in useful ways, and to make science fiction a reality. But, nanotech’s value must be weighed the consequences. Part 2 of this series explores the potential dangers of nanotech.

read more

You may be interested in the cover article from the Winter 2010 Issue of the ABA Section of Litigation magazine, Litigation News – “The Rise of Nanotech Litigation.”  

 

The article by Litigation News Associate Editor Kristine Roberts is, in my view, a substantially scaled down summary of a number of my previous articles on the subject, including "The Dawn of the Age of Nanotorts", published last year by BNA in three of its subject-matter reporters - Class Action Litigation, Toxics Law, and Product Safety & Liability.  

 I’m glad to see someone out there is reading. 

 

Roberts also includes a few comments from Section of Litigation members on likely nanotech-related product liability and exposure litigation.  Below are a few excerpts from the Roberts article. 

 

 

read more

Nick Dudley, a third-year law student at the University of Minnesota Law School, has prepared an interesting primer on nanotechnology and the likely effects on products liability litigation and risk management.  This is Part 1 of 4.   read more

The editors of Scientific American write that the United States Environmental Protection Agency (EPA) must act swiftly to evaluate the possible health risks of nanotechnology.

Nanotechnology, they say, could emerge as an important tool to fight the threats of global warming and disease, but nanomaterials carry with them the potential for both good and harm.

read more

"Tiny Objects, Big Concerns: Managing Nanotechnology Risks” , from the Claims Magazine, December 2009 issue, is wonderful reading to close out 2009.

 Author Kevin Quinley has gravitas: over 30 years of experience in claims and a recognized insurance claim expert, trainer, author, and consultant. Quinley holds the CPCU designation as well as four specialty designations from the Insurance Institute of America: Claims (AIC), Risk Management (ARM), Management (AIM), and Reinsurance (ARe). He also serves on the Advisory Board of the Council of Litigation Management and the Insurance Institute’s Board of Ethical Inquiry.

To read the full article, see the link above.   But here is some of what Quinley has to say that this toxic exposure and nanotort lawyer/blawger finds to be great advice for risk managers, liability insurance professionals (both underwriting and claims), and their outside legal counsel. read more

"Nanoparticles – one word: A multiplicity of different hazards"

That is the title of an Editorial written by twelve (12) leading nano-scientists from around the world and published in the December 2009 issue of the journal Nanotoxicology (December 2009, Vol. 3, No. 4, Pages 263-264).  The Editorial was written to draw the attention of the nanotoxicology community to how the term "nanoparticles" is being used indiscriminately and misleadingly, particularly in the titles of scientific papers and statements to the general media. The authors are disturbed and concerned that the lack of precision can, and in fact already has, created dangerously misleading and unscientifically supportable overgeneralizations about nanoparticle hazards.
read more

Need a holiday gift for your favorite Nanotechnophile?

Environmental and Human Health Impacts of Nanotechnology (J. Lead & E. Smith, eds., published by Wiley-Blackwell, October 19, 2009, 456 pp.) looks like a valuable resource for anyone keenly interested in nanotech environmental, health, and safety (EHS), whether academic researchers, scientists in industry, regulators, risk managers, or toxic exposure lawyers.

read more

Part 1 of the discussion examined the structural and systemic forces in the American tort system that will lead to the reality of nanotechnology-focused tort claims in the near future. In Part 2, I began to discuss some specific claims that are likely in early nanotort litigation, including medical monitoring claims.  Here, in Part 3, I continue that claim-specific discussion, with a focus on possible class action claims. read more

A speaker at the workshop "Nanomaterials and Human Health & Instrumentation, Metrology, and Analytical Methods," being held this week as part of the White House's National Science and Technology Council, said, in a talk he meant to be provocative, that researchers can use cellular tests to obtain any result they want concerning the toxicity of a nanomaterial. read more

A new UK-based nanoparticle risk research center was launched this week.  

Edinburgh (Scotland) Napier University's new Centre for Nano Safety has been set up to identify whether a variety of nanoparticles can enter the human body – as well as other species such as bacteria, insects and plants – and cause harm.   The Centre's mission is to study the possible toxicity of nanoparticles, both biotoxocity and ecotoxicity.

read more

On October 26, 2009, The Advisory Committee on Hazardous Substances to the United Kingdom's Department of Environment, Food and Rural Affairs (Defra), issued a "Report on Nanosilver.”  The Report warns that more information on both the hazards of and exposure to nanosilver is urgently required, and recommended to British agencies that they gather information about products containing nanosilver. read more

A new study published October 25, 2009, in Nature Nanotechnology online --  "Inhaled Carbon Nanotubes Reach the Subpleural Tissue in Mice" --  provides further evidence for the asbestos-like effects of certain types of carbon nanotubes.

The study, by researchers at North Carolina State University, The Hamner Institutes for Health Sciences, and the National Institute of Environmental Health Sciences (all in the United States), found for the first time that multi-walled carbon nanotubes (MWCNTs) reach the outer lining of the lung when inhaled - as asbestos does.  The findings raise concerns that inhaled nanotubes may cause pleural fibrosis and/or mesothelioma.

read more

An article by Reed D. Rubinstein of Greenberg Traurig LLP, in the new issue of Nanotechnology Law & Business (Fall 2009), discusses a “petition” filed with the United States Environmental Protection Agency (EPA) by the International Center for Technology Assessment (ICTA) and other special interest groups. The Petition claims that “research has mounted to indicate that nano-silver materials pose serious risks to human health and the environment.” As a result, the Petition demands (among other things) that the EPA regulate all nano-silver products as pesticides, and stop the use or sale of all consumer products using nano-silver under the authority of FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act. read more

Concerns have been raised about whether workers exposed to engineered nanoparticles are at increased risk of adverse health effects. The current body of evidence about the possible health risks of occupational exposures to engineered nanoparticles is quite small, and uncertainty means risk.

A new Canadian study to appear in a forthcoming issue of the International Journal of Nanotechnology suggests that current protective equipment used for existing chemicals may not offer adequate protection for workers handling nanomaterials. The study, by engineers in the Department of Mechanical Engineering at Montreal’s School of Higher Technology, suggests that urgent research is necessary into the risks associated with the growing field of nanotechnology manufacture so that appropriate protective equipment can be developed. Prevention of harmful exposures from ingestion, inhalation, and dermal absorption are the reason that protective clothing and gloves, in addition to respirators, are often an essential and common sight in the chemical industry. However, the Canadian researchers wonder if standard protection against chemical risks is enough for workers who are handling nanomaterials. read more

On October 5, 2009, the Wisconsin Department of Natural Resources hosted a roundtable discussion with Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington, D.C.

Discussion topics include nanotechnology basics and definitions, manufacturing process and opportunities, regulatory status, and potential environmental and health concerns.
read more

In a 10/12/09 post with the above-title, GreenFudge.org poses the important question, which has no clear answer:  "So what’s so scary about nanotechnology?"

With technological progress comes the increased potential for misuse and harm. The post suggests that fears about nanotechnology include those imagined (for example, tiny machines let loose into the environment; self-replicating nanobots that could conceivably become corrupt or out of control and act in a similar way that cancer cells – biological cells gone awry – do in organic bodies) and perhaps more realistic (imagine powerful nanotech in the wrong hands; dangerous nanoparticles being released into food and water sources by terrorists). And the fact that we simply still don’t know what nanotech is capable of, just as we used to be unaware that certain chemicals are poisonous or harmful to the environment or that CFCs were cutting a hole in the ozone layer.

Of course it is the latter type of fear that is of greatest practical significance to those companies involved with the manufacture and disrtibution of nanotechnology-enabled products, along with those in the risk management chain and their counsel.

read more

The Research Triangle Environmental Health Collaborative (The Collaborative) will gather 150 experts from around the nation at its second annual environmental health summit on October 8-9, 2009. The 2009 summit, “Environmentally Responsible Development of Nanotechnology,” is being held at the North Carolina Biotechnology Center in North Carolina’s Research Triangle Park.

This year’s summit features a broad and experienced group of participants representing wide areas of expertise and diverse views from Federal, State, and local governments; academia, industry, and public interest organizations. Speakers include Mark Wiesner, of Duke University’s Center for the Environmental Implications of NanoTechnology (CEINT), and Chad Holliday, Chairman of the Board and former CEO of DuPont, Inc.
read more

Prudent manufacturers, sellers, and employers in the Nanotechnology community must maintain knowledge of all relevant standards, whether governmental or voluntary. Although standards developed by organizations like ASTM International are not government-issued mandatory standards with the force of law, they can be extremely important. In some cases, governments will adopt such voluntary standards, thus giving them legal effect. Even if not, evidence of compliance or noncompliance can have a powerful impact in personal injury litigation regarding issues of state of the art, negligence, recklessness, and punitive damages.

ASTM International, originally known as the American Society for Testing and Materials (ASTM), is one of the largest voluntary standards development organizations in the world.  In order to make the consensus standards being developed by ASTM more visible to the Nanotechnology community, ASTM now has a new Nanotechnology-focused page on its website.  ASTM standards for nanotechnology provide guidance for nanotechnology and nanomaterials, as well as nanotechnology terminology, property testing, and issues of health and safety.

ASTM has thus far issued one standard concerning Nanotechnology health and safety, the Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings, published October 2007.

read more

The core business of the insurance industry is the transfer of risk. Thus the insurance business identifies, evaluates and diversifies risk in order to minimize the total capital cost of carrying it. However, the traditional means of diversification reach their limits when:
– it is no longer possible to assess the probability and severity of risks
– many companies, industry sectors and geographical regions are affected simultaneously
– the magnitude of a possible event exceeds the capacities of the private insurance industry

Nanotechnology, as an emerging risk, challenges the insurance industry because of the high level of uncertainty in terms of potential nanotoxicity or nanopollution, the ubiquitous presence of nano-products in the near future (across industry sectors, companies and countries) and the possibility of long latent, unforeseen claims.

Nanotechnology risks implicate many lines of business:
– General liability
– Products liability
– Products recall
– Environmental liability
– Hazardous material transportation
– Property damage
– Workers’ compensation

read more

Greek philosopher Epictetus observed: "People are disturbed, not by things, but by the view they take of them." Risk perception research offers insights into likely public reaction to nanoscience and nanotechnologies, which has implications for risk management and nanomaterial litigation trends.

The prospect is real that various nano-scares could emerge in the future – fueled by message boards, blogs, interest group web sites and the traditional media.  Therein lies the heightened danger of perceived risk in the Age of Nanotechnology.  Risk perception, even when not supported by science, can lead to political pressure, government action, and can sow seeds of potential personal injury litigation. For nanotechnologies, these psychological and sociological phenomena will be powerful forces to be monitored by mass tort lawyers just as with the hard risk assessment science. Rational discourse will be important. To that end, mass tort and toxic tort lawyers will be important players in ensuring that irrational risk perception and the impact of nanotort litigation does not stifle otherwise beneficial technology.

read more

The Age of Nanotechnology is here. Welcome to the Nanotort Law Blog.  

The Nanotort Law Blog aims to be a useful resource for lawyers and risk managers. It will help you stay abreast of the current state of hazard assessment knowledge, pertinent governmental regulation, industry and NGO standards and guidelines, and other important information germane to environmental, health, and safety risks and potential liabilities. The Nanotort Law Blog will also offer ideas and links to other helpful resources to help you monitor, understand and manage the potential - and as yet unkown - liability risks of Nanotechnologies.

read more