Nano and Other Emerging Chemical Technologies Law Blog: Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotech and Chemical Legal Developments

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced on September 28, 2011, the availability of a review of the 2007-2009 literature on toxicological and health effects relating to six nanomaterials. NICNAS commissioned the review and analysis of literature concerning fullerenes, carbon nanotubes, and nanoforms of zinc oxide, titanium dioxide, cerium oxide, and silver. According to NICNAS, it chose these nanomaterials because it considers them “to already be in, or close to, commercial use in Australia.”  The goal of the review was to identify any available scientific evidence of important toxicological/health effects that had not been covered by the scope of previous reviews and therefore supplement currently available scientific information on these substances.

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During the September 23, 2011, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) conference organized by the European Chemicals Agency (ECHA) and European Commission (EC), Astrid Schomaker, Directorate-General (DG) Environment, stated that the EC has been working on a definition of nanomaterials, and that it “should be coming after the summer.” The EC previously stated in a letter to the Dutch Environment Ministry that it would publish a definition by the end of June. Karl Falkenberg, Director-General for DG Environment, stated that the issue is “triangular -- we have to put together environmental, trade and health perspectives.” Conference delegates disagreed whether nanomaterials are appropriately addressed under REACH. According to Alexander Nies, Deputy Director-General for Germany’s Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, ECHA has found only three cases where substances qualify as nanomaterials, even though there are “more than 900 companies in Germany that produce nanomaterials.” Nies urged the EC to adapt REACH to deal with the specific features of nanomaterials. Adrian Harris, Director-General for the European Engineering Industries Association, responded that the Association supports “rationalization” rather than increasing demands under the registration process. Harris stated that “REACH in its present form is fit to address nanotechnology.”

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The Office of Environmental Health Hazard Assessment (OEHHA) has posted comments received on its July 29, 2011, revised proposed regulation concerning the specification of hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in California’s Toxics Information Clearinghouse.  The California Department of Toxic Substances Control (DTSC) will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. OEHHA’s August 2010 pre-regulatory draft regulation included a “nanomaterial hazard trait,” as well as other references to nanoparticles, which OEHHA removed from its December 17, 2010, draft regulation. The revised regulation does not refer to nanomaterials or nanoparticles, but includes the following definition regarding particle size or fiber dimension:

(a)        The particle size or fiber dimension hazard trait is defined as the existence of a chemical substance in the form of small particles or fibers or the propensity to form into such small-sized particles or fibers with use or environmental release.

(b)        Evidence for the particle size or fiber dimension hazard trait includes, but is not limited to:  measures of particle size less than or equal to 10 micrometers in mass median aerodynamic diameter for inhalation exposure, or less than 10 micrometers in any dimension for dermal or ingestion exposure, or fibers with a 3:1 aspect ratio and a width less than or equal to 3 micrometers.

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On September 22, 2011, during a meeting of nano interests in Washington, D.C., the following people spoke:

• Jeffrey Weiss, Senior Director, Technical Barriers to Trade, Office of the United States Trade Representative, “U.S. Trade Policy and Nanotechnology”;
• Richard A. Canady, Ph.D., Director, Center for Human Health Risk Assessment Research Foundation, International Life Sciences Institute (ILSI), “NanoRelease and NanoCharacter Projects”; and
• Maria J. Doa, Ph.D., Acting Director of Chemical Control Division, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency (EPA), “Regulation of Carbon Nanotubes under the Toxic Substances Control Act.”

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The Silver Nanotechnology Working Group (SNWG) recently prepared a statement concerning nanosilver and its long history of safe and regulated use. SNWG notes the similarities between nanosilver and other antimicrobial silver materials available in the marketplace.  SNWG states that it “has interacted with the [U.S. Environmental Protection Agency (EPA)] in challenged exchanges on how best to regulate nanopesticides leading to a clear, reasonable, and responsible path for registration.” SNWG urges EPA and other agencies not to impose unwarranted barriers to emerging nanotechnology industries. Instead, SNWG asks that EPA and other agencies “nourish the benefits these can provide while screening finished products claiming pesticidal properties on a case by case basis for any environmental risk.” SNWG seeks “a sensible path forward for registering nanopesticides that is not burdensome for either the government or industry.”

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On September 18, 2011, Nature Nanotechnology posted an article entitled “Cell entry of one-dimensional nanomaterials occurs by tip recognition and rotation.” The authors state that materials with high aspect ratio, such as carbon nanotubes (CNT) and asbestos fibers, have been shown to cause length-dependent toxicity in certain cells because these long materials prevent complete ingestion, which frustrates the cell. The authors note that, while “[b]iophysical models have been proposed to explain how spheres and elliptical nanostructures enter cells,” one-dimensional nanomaterials have not been examined. The authors show “experimentally and theoretically” that cylindrical one-dimensional nanomaterials, such as CNTs, enter cells through the tip first. The abstract states:

For nanotubes with end caps or carbon shells at their tips, uptake involves tip recognition through receptor binding, rotation that is driven by asymmetric elastic strain at the tube-bilayer interface, and near-vertical entry.  The precise angle of entry is governed by the relative timescales for tube rotation and receptor diffusion.  Nanotubes without caps or shells on their tips show a different mode of membrane interaction, posing an interesting question as to whether modifying the tips of tubes may help avoid frustrated uptake by cells.

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The German Advisory Council on the Environment (SRU) released on September 1, 2011, a report entitled Precautionary Strategies for Managing Nanomaterials, which makes recommendations for a “responsible and precautionary development” of nanotechnology. According to SRU, its objective is to allow for innovation while also identifying and reducing risks at an early stage. SRU concludes that while chemical, product, and environmental regulations are “generally applicable” to nanomaterials, the specific characteristics of nanomaterials could impede the application of the regulations. Closing the regulatory gaps “would require a uniform definition for nanomaterials, their treatment as separate substances in chemicals risk assessments and the obligation for manufacturers to submit data sets specifically adapted to nanomaterials.” SRU states that activities that it believes pose “a certain cause of concern are, in particular, the use of nanomaterials in consumer sprays, the growing sales of consumer products containing silver nanoparticles and the production and processing of carbon nanotubes, which are suspected to be carcinogenic -- especially those with a high aspect ratio.” To increase transparency regarding the presence of nanomaterials in consumer products, SRU recommends a register for products containing nanomaterials and an extension of existing labeling requirements. The SRU was founded in 1971 to advise the German government and consists of seven university professors from a range of different environment-related disciplines.  SRU’s advice is independent from external instructions.

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The August 25, 2011, issue of Nature includes a letter from Hermann Stamm, European Commission (EC) Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP). In response to Andrew Maynard’s article entitled “Don’t define nanomaterials,” in the July 7, 2011, issue of Nature, Stamm argues that a definition of engineered nanomaterials for regulatory purposes is “urgently needed.” Maynard proposes that a “‘one size fits all’ definition of nanomaterials will fail to capture what is important for addressing risk,” and suggests that regulators use “a list of nine or ten attributes (including size and surface area) for which certain values trigger action.” Stamm, however, maintains that size is “the most appropriate parameter on which to base a broad definition.” Maynard concludes that adaptive regulations are necessary to respond to scientific evidence, while Stamm acknowledges that a definition “would need revision in line with fresh scientific evidence.”

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