Environmental Law ReSource : Environmental Lawyer & Attorney : Reed Smith Law Firm : Climate Change, Sustainability

This post was written by David Wagner.

Underscoring the U.S. Environmental Protection Agency (USEPA) intent to issue rules regulating nanomaterials this year, the U.S. Government Accountability Office (GAO) raised some concerns and offered remedies in its report issued late last month titled, “Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk”.

In the report, GAO (an investigative arm of the U.S. Congress) stated its concerns that products with nanomaterials may be entering the market without USEPA review of all available information on their potential risk. Moreover, USEPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the relevant statutes include volume-based regulatory thresholds that may be too high to effectively regulate the production and disposal of nanomaterials.

Before offering recommendations, the GAO report discussed the growing world market for products that contain nanomaterials, which is expected to reach $2.6 trillion by 2015. The report identified a variety of products that currently incorporate nanomaterials already available in commerce across the following eight sectors: automotive; defense and aerospace; electronics and computers; energy and environment; food and agriculture; housing and construction; medical and pharmaceutical; and personal care, cosmetics, and other consumer products. Within each of these sectors, GAO also identified a wide variety of other uses that are currently under development and are expected to be available in the future. According to GAO, the extent to which nanomaterials present a risk to human health and the environment “depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials.”

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This post was written by David Wagner.

Last month, the U.S. Environmental Protection Agency (USEPA) reported in its Unified Agenda that two rules related to nanomaterials may be proposed this year. The first possible regulation is a reporting rule for as yet unspecified nanoscale materials under Section 8 of the Toxic Substances Control Act (TSCA). A notice of this proposed rulemaking is slated for June 2010. The second possible regulation, under Section 4 of TSCA, is a test rule for certain multi-wall carbon nanotubes as well as nanoscale clay and alumina. USEPA reported that notice of the test rule is scheduled to be published in November 2010.

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This post was written by David Wagner.

The U.S. Environmental Protection Agency (USEPA) is continuing its enforcement efforts against manufacturers who claim that their products contain antimicrobial properties without registering the product as a pesticide under the federal pesticide law.  On October 21, 2009, USEPA fined Samsung $205,000 for violating the federal fungicide, insecticide and rodenticide act (FIFRA) by failing to register its products with USEPA when it publicized that its keyboards, produced with nanosilver, were antimicrobial and inhibited germs and bacteria.  FIFRA prohibits unsubstantiated public health claims regarding unregistered products.  According to USEPA, the health-related claims made on the company's labels and promotional material for netbook and notebook computer laptops would render the products pesticides, requiring registration under the law.  In addition to the fine, Samsung must provide a certification that it has complied with fifra by removing all pesticidal claims made in connection with the sales and distributions of these products.  Samsung also agreed to notify its retailers and distributors to remove any pesticidal claims from labels, promotional brochures and internet/web-based content for the subject products.

This is the second FIFRA enforcement action in the last two months targeting consumer products.  In September, USEPA filed a lawsuit against the North Face Company alleging that they sold shoes containing an unregistered pesticide and made unverified health-related claims for about 70 shoe products using agion silver ion technology. If you have questions regarding whether your product claims could require registration under FIFRA, you should have them reviewed by counsel with expertise in this area.

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This post was written by David Wagner.

On September 21, 2009, the U.S. Environmental Protection Agency filed a complaint against VF Corporation for the alleged sale and distribution of unregistered pesticides through its outdoor gear company, The North Face. VF Corporation faces up to $1 million in fines for selling shoes containing an unregistered pesticide and making unverified health-related claims for about 70 shoe products using AgION silver ion technology. Although the products do not claim to use nanomaterials, the alleged claims in the complaint are similar to claims for antimicrobial products containing nanomaterials. In fact, this lawsuit is similar to the February 2008 suit filed by USEPA against a technology company for allegedly making unsubstantiated claims about the antimicrobial capabilities of its computers keyboards and mouse accessories.

In its complaint, USEPA stated the company made unsubstantiated claims about its footwear, including claims that “AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria” and that its product “prevents bacterial and fungal growth”. Products discovered online and evidence found at The North Face retail store in San Francisco led USEPA to file the complaint under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), which prohibits unsubstantiated public health claims regarding unregistered products.

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This post was written by Tony Klapper and Jesse Ash.

A study published this summer claims an association exists between exposure to nanoparticles and the deaths of two workers and the illnesses of five others in a horribly ventilated, cramped Chinese factory.  While the authors conclude that long-term exposure to nanoparticles without protective measures may be related to serious damage to human lungs, the study has several significant flaws.  This Reed Smith client bulletin provides some details on the study's findings and its weaknesses while framing the results in the larger context of the need to employ appropriate risk management practices when making or using nanomaterials.

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This post was written by David Wagner.

On August 4, EPA published a report discussing its intent to develop a data collection rule for nanoscale materials under Toxic Substances Control Act’s (TSCA) Section 8(a). Section 8(a) requires certain manufacturers, importers, or processors of a chemical substance to maintain records and submit reports of production and exposure information. 

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This post was written by Tony Klapper and Jesse Ash.

On April, 8, 2009, the National Institute for Occupational Safety and Health ("NIOSH") and the Centers for Disease Control and Prevention ("CDC") submitted a notice for public comment in the Federal Register, requesting information to evaluate potential health risks associated with the use of carbon nanotubes ("CNTs"). 74 Fed. Reg. 15985-15986 (Apr. 8, 2009). NIOSH and CDC request by May 15, 2009, all information related to studies, workplace exposure data, and information on control measures where companies manufacture CNTs in products. The agencies plan to use this information to formalize recommendations for the safe handling of products that contain CNTs.

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This post was written by Christopher Rissetto, Stephanie Giese and Areta Kupchyk.

The Environmental Protection Agency announced Nov. 19, 2008 that it is seeking public comments on a petition asking it to regulate nanosilver products as pesticides.  The authors of this article discuss that petition, a related petition sent to the Food and Drug Administration, and other activities at federal regulatory agencies and in the Congress affecting products that incorporate nanomaterials.  They expect a new regulatory environment to develop in 2009 for companies producing and selling such products. 

To learn more, please click here for the full article.

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This post was written by David Wagner.

On Oct. 8, 2008, the European Commission amended REACH to remove nanoscale carbon and graphite from its list of exempted substances. The substances were originally listed in REACH's Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties. Following a review and a report by an expert committee, the Commission changed its position. According to the regulation, there is insufficient information for carbon (CAS No. 7440-44-0) and graphite (CAS No. 7782-42-5) to be listed in Annex IV, "in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion" in Annex IV. As a result, both substances are now required to be registered under REACH.

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This post was written by David Wagner.

Over the past few months, nanotechnology has been in the news.  Four items are worth noting:

• In February, the U.S. Environmental Protection Agency fined a California technology company for failing to register nanomaterial under the Federal Insecticide, Fungicide and Rodenticide Act.  The $208,000 fine was based on the company's failure to register its products as pesticides and for allegedly making unverified claims relating to the antimicrobial capabilities of the nano-silver coatings used in its computers keyboards and mouse accessories.
• In May, a scientific report in the journal Nature Nanotechnology discussed a possible link between carbon nanotubes and the development of precursors of mesothelioma.
• Shortly thereafter, NGO groups petitioned USEPA, calling for the review and control of some 260 nano-silver products. See Posting "Citizen Petition for Regulation of Nano-Silver (June 16, 2008).
• Then in June, the European Commission issued guidance in addressing nanomaterials under REACH, its new chemicals regime.  The guidance indicated that for the nanoscale form of a substance on the market in bulk, the European Commission may require additional information on the specific properties or additional risk management measures. While there is still significant uncertainty about the regulation of nanomaterials, companies working with nanomaterials should closely track what scientists say, what NGOs threaten, and what regulators do both here and abroad.  There is increasing scrutiny of chemical substances throughout the world, and understanding recent developments and the related legal requirements will likely mitigate liability exposure and the business risk associated with nanomaterials. 

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This post was written by Antony Klapper, Margaret L. Sanner and Jesse Ash.

In June 2008, scientists at the University of Edinburgh Centre for Inflammatory Research, the Woodrow Wilson International Center for Scholars and other locations released results from a study linking carbon nanotube (CNT) exposure in mice to the development of cell pathologies associated with asbestos exposure.

The widely publicized research specifically found that exposing the mesothelial lining of the body cavity of mice to long-fibered CNTs results in asbestos-like pathogenic behavior, including the formation of cell lesions of the type which are known precursers to mesothelioma development in humans.

To learn more, please click here for the full article.

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This post was written by Christopher Rissetto, Stephanie Giese and Areta Kupchyk.

In response to the influx of products engineered using nano-silver in the consumer marketplace, the International Center for Technology Assessment (“CTA”), in conjunction with a number of other consumer groups, filed a self-styled Petition For Rulemaking To The United States Environmental Protection Agency (“Petition”) on May 1, 2008.  The Petition, citing to the rulemaking provisions of the Federal Administrative Procedure Act (“APA”) and other statutes, calls for the review and control of some 260 nano-silver products, most specifically through the regulatory process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).  In the Petition, CTA claims “nanomaterials present serious toxicity risks for human health and ecosystems” and asserts that “nano-silver has quickly become the most commonly used nanomaterial in consumer products.”  The scattershot but substanti-ated approach of the Petition, combined with its prior administrative filings, and recent Environmental Protection Agency (“EPA”) enforcement and rulemaking actions, could well lead to future federal efforts to control nano-silver products.

To continue reading, please see the full article.

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This post was written by Chris Rissetto, Margaret Sanner and Stephanie Giese.

In May 2008, scientists released results from a study linking carbon nanotube (CNT) exposure in mice to the development of cell pathologies identified as possible precursors to mesothelioma in humans.  The findings made international news, with the New York Times, Washington Post, the L.A. Times, BBC and AFP all reporting on it.

It must have been a slow news day, because this was not new news.

As the authors in the study made clear, the results were “predicted,” given what scientists already knew about the inflammatory effect of long, thin, fiber-shaped substances.  In fact, in 2007, Reed Smith attorneys wrote about the parallels that others have drawn between CNTs and asbestos, citing an even earlier (2004) British report.

Please click here to learn more.

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This post was written by David Wagner, Jesse Ash and Tony Klapper.

On May 5, 2008 a meeting was held at the National Academy of Sciences to review the National Nanotechnology Initiative's (NNI) April 2008 update on the federal strategy to address environmental, health and safety research needs for engineered nanoscale materials. The National Resource Council (charged with auditing the NNI findings) chaired the conference. Council members include Drs. Andrew Maynard and Gunther Oberdorster. Panelists included the American Chemical Council (ACC), Dupont, AFL-CIO, NRDC, the Consumer's Union, the Dept. of Energy, the Dept. of Defense, and European Union representatives. The panelists were asked to provide their viewpoint on the NNI document. In general, the NNI document outlines the steps that government should follow to assess risks. 

Panel members on behalf of workers, consumers and the NRDC were skeptical about the NNI strategy, claiming it gave no specifics on how the federal government would assess risks. Panelists involved the specifics of asbestos and Bisphenol A (BPA) were often in their presentations to the Council, arguing that more needs to be done more quickly. NRDC went as far as to say it is "criminal" that the government doesn't have a plan in effect today since nano-products are already in use today. The representative from Consumer's Union pointed out there was no consumer exposure assessment data in the NNI document.

Panel members on behalf of industry (ACC and Dupont) were generally happy with the NNI update but also agreed with other panelists that more was needed now to assess risks. Dupont also outlined its Nano Risk Framework. In response to a question from the Council on what industry is doing to assess risks, Bill Gulledge with ACC explained that most of his members have product stewardship programs, treat nanomaterials as hazardous, and meet periodically to discuss nano risks.

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This post was written by David Wagner and Jesse Ash.

In March 2008, The Government Accounting Office put out a Report on Nanotechnology.  The report reviews what each agency has accomplished to date on researching environmental, health and safety risks.  Of the $1.3 billion allocated to nanotechnology research in 2006, $37 million was devoted to research associated with risks.  The report concludes that agencies are still in the formative stages of identifying and prioritizing risks and need better guidance from the Office of Science and Technology and OMB on reporting their research findings.  Companies manufacturing, integrating, or selling products containing nanomaterials should take notice that the government is taking risk-related issues seriously and will continue to spend a great deal of time and money looking at the risks associated with nanotechnology. 

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