Industry Best Practices

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.

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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. 

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On 12/20/11, the National Institute of Standards and Technology issued the world's first standard reference material for single-wall carbon nanotubes. 

NIST also issued a proposed material safety data sheet for single-wall carbon nanotubes.

Carbon nanotubes are the most commonly used nanomaterial in industrial applications and both the reference material and MSDS are important to companies that make or use single-wall carbon nanotubes. Having NIST's reference materials provides an important starting point for companies developing their own SWCNTs or developing applications for existing SWCNTs.

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In a new report, “The Sourcing Framework for Food and Food Packaging Products Containing Nanomaterials”, by the United States-based non-profit organization, As You Sow, sxperts in environmental health issues teamed with major companies to advise food industries to exercise caution when using nano-sized, manmade creations as nutritional additives, flavorings, colorings, or anti-bacterial coatings for packaging.

As You Sow teamed up with several major food companies, including Kraft, McDonald’s, Whole Foods, Yum! Brands, and Pepsi, to create the Framework. According to the study, as "food and food packaging companies explore the use of nanomaterials to enhance products, they need also attend to potential risks introduced."

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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.

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A new study published in the June 2011 issue of The American Journal of Pathology, "Length-Dependent Retention of Carbon Nanotubes in the Pleural Space of Mice Initiates Sustained Inflammation and Progressive Fibrosis on the Parietal Pleura", shows that carbon nanotubes could pose risks in the occupational setting. The study was conducted by the University of Edinburgh, United Kingdom, and follows previous research in mice looking at the effect of carbon nanotubes on the stomach cavity.

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The International Organization for Standardization (ISO) has released a new publication, "Nanotechnologies: Nanotechnology Risk Evaluation," ISO/TR 13121:2011, which describes a process for “for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment.”

The publication also offers guidance about making sound risk evaluations and risk management decisions, and information on how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices.

Also included are methods to update assumptions, decisions and practices as new information becomes available – which is almost continuously in the nanomaterial EHS field. Additionally, the document describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials, for transparency and accountability.

Source: International Organization for Standardization

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On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed  in response to a request from the European Commission,

 

“Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” is the work of the EFSA’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives and pesticides.

 

The EFSA guidance sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties.

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"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.

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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.

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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.

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The NanoBusiness Alliance, the world's leading nanotechnology trade association, will hold the 9th annual NanoBusiness 2010 conference and exhibition, at McCormick Place in Chicago on September 27-28.  For event details, including the conference schedule and registration information, visit http://www.nanobusiness2010.com.

This year’s conference focuses on the issues that are of top-line importance to the NanoBusiness Alliance’s constituents, and includes sessions on:

-  Innovations In Nanotechnology

-  Creating an Ecosystem for Nanotechnology Commercialization

-  Environmental, Health and Safety

-  Nanomedicine

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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.

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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.”

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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.

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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.

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On July 1, 2010, the NanoBusiness Alliance issued a “Position Statement on Nanomaterials Product Sustainability,” which reflects NanoBusiness Alliance members’ commitment to managing effectively the environmental, health, and safety (EHS) implications of nanotechnology.

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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.

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A report titled "Nanotechnology, Health and the Environment" will be presented at the Nano Science and Technology Institute's (NSTI) “Nanotech Conference & Expo 2010” in Anaheim, CA, June 21-24, 2010. 

The report is available for download at Nanotechnology - Greenberg Traurig, LLP.

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Carbon nanotubes and other carbon nanomaterials are now, and are expected to remain, the most commonly used nanomaterial in industrial applications. They are also used in a wide variety of consumer products and that trend is expected to continue. Early research has already raised questions, if not concerns, about the environmental, health, and safety risks of some carbon nanomaterials, such as single-and multi-walled carbon nanotubes.

Twelve (12) leading companies involved in the commercialization of carbon nanomaterials and products recently formed the NanoSafety Consortium for Carbon ("NCC") to address nanoscale carbon environmental, health, and safety issues related to the responsible commercialization of their products.

The NCC website is designed to inform the public about its activities.

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“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).

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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

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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."
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Many researchers working with nanomaterials use inadequate protection, if any at all, and most don't use special disposal methods for nanomaterials, claims a new study published January 2010 in Nature Nanotechnology.  The study is discussed in a January 31, 2010, post by Kate McAlpine, at Britain's highly regarded Royal Society of Chemistry, Chemistry World website.  www.rsc.org/chemistryworld/News/2010/January/31011001.asp

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"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

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.
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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.
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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.

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As with any new technology, the earliest and most extensive exposures to engineered nanoparticles are likely to occur in the workplace. Workers may be exposed to nanomaterials during the manufacturing, end use, or during the disposal or recycling of nanomaterial-containing products and workplace exposure levels and frequencies are likely to be higher than that seen in the general environment.   The National Institute for Occupational Safety and Health (NIOSH) is the leading federal agency conducting research and providing guidance on the occupational safety and health implications and applications of nanotechnologies.   Workplace exposure risks associated with the manufacturing of nanomaterials come within the auspices of the Occupational Safety and Health Act, 29 U.S.C. §651 et seq., and the regulations promulgated under the Act.     Maintaining current knowledge of the state-of the art in nanomaterial safety research is imperative for risk managers, insurance professionals, and their attorneys because the Act’s general duty clause requires that an employer must provide each employee with “a place of employment . . . free from recognized hazards that are likely to cause death or serious physical harm.” 29 U.S.C. §654(a)(1).
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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.

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