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

As You Sow, a non-governmental organization (NGO), has published a framework providing guidelines intended for food and food packaging companies to assess exposure to and potential risks from food and food packaging products containing nanomaterials. According to As Your Sow, more than a dozen food companies, scientific organizations, and investor groups reviewed the framework, including:  Kraft, McDonald’s, PepsiCo, Whole Foods, and Yum! Brands; the Center for Food Safety, Consumers Union, Project on Emerging Nanotechnology, International Center for Technology Assessment, Natural Resources Defense Council, and the Technical University of Denmark; As You Sow, Calvert Investments, and the Investor Environmental Health Network.  The framework offers tiered recommendations of steps companies should take and information they should obtain from their suppliers regarding the safety testing of nanomaterials and products containing nanomaterials.  As You Sow recommends that, until there are “firm regulatory requirements and/or a central repository for safety data on nanomaterials, information requested in this framework should be provided to food and food packaging companies by their suppliers.” 

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A coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011.  The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy. ICTA states that its lawsuit “demands” FDA respond to the coalition’s 2006 petition. The 2006 petition requested FDA take several actions, including requiring specific product labeling and health and safety testing; analyzing the environmental and health impacts of nanomaterials in products approved by FDA; and regulating sunscreens containing nanomaterials. In the December 21, 2011, complaint, the coalition states that, since 2006, “nanomaterial consumer products have continued to proliferate without oversight.” The coalition asks the court to order FDA to respond to its 2006 petition without further delay.

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The U.S. Environmental Protection Agency (EPA) published on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.”  EPA states that because of a lack of established nomenclature for CNTs, the Toxic Substances Control Act (TSCA) Inventory names for CNTs are currently in generic form, e.g., “carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).” EPA uses the specific structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information (CBI). The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Comments are due January 27, 2012.

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On December 20, 2011, the National Institute of Standards and Technology (NIST) announced it issued the world’s first reference material for single-wall carbon nanotube soot.  According to NIST, “nanotube-laden soot is the primary industrial source of single-wall carbon nanotubes, perhaps the archetype of all nanoscale materials.” NIST states that the new material “offers companies and researchers a badly needed source of uniform and well-characterized carbon nanotube soot for material comparisons, as well as chemical and toxicity analysis.” NIST certifies each unit of SRM 2483 for the mass fraction values of several common contaminants, including barium, cerium, chlorine, cobalt, dysprosium, europium, gadolinium, lanthanum, molybdenum, and  samarium.  NIST provides reference values (values believed to be accurate, but not rising to the level of confidence that NIST certifies) for an additional seven elements. NIST has also posted a material safety data sheet (MSDS) for the reference material.

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The European Parliament (EP) passed a resolution on December 15, 2011, stating that nanomaterials must be covered by current European Union (EU) health and safety rules, based on a mid-term review of the EU’s 2007-2012 health and safety at work strategy. The resolution, which was adopted with 371 votes in favor, 47 against, and 15 abstentions, also calls for the assessment of the effects of new technologies on health. The EP calls for legislation to ensure that nanomaterials are covered by the current European Occupational Health and Safety regulation.

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Japan’s Ministry of Economy, Trade and Industry (METI) established a Committee on Safety Management for Nanomaterials, which was scheduled to hold its first meeting on December 2, 2011. METI states that it established the Committee “on the basis of the results obtained from the project ‘Research and Development of Nanoparticle Characterization Methods’ commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge.”  The Committee will focus on risks caused by nanomaterials, and study appropriate management procedures for nanomaterials considering the actual usage and life cycles. According to Japan’s November 30, 2011, press release, the Committee will compile an interim report “around spring to summer in 2012.”

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On November 23, 2011, the European Union (EU) Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for “problematic” substances. The proposed legislation states that there is “scientific uncertainty” about the safety of nanomaterials, and “to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.” The proposed legislation calls on the European Commission (EC) to “regularly review the provisions on nanomaterials in the light of scientific progress.”

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The European Commission (EC) requested on December 9, 2011, that the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. According to the EC, while recent review papers suggest that nanosilver may not be hazardous to humans, data are insufficient to carry out a full risk assessment. The EC states that indirect adverse effects on human health may occur via an increasing resistance of micro-organisms against silver, including nanosilver and silver-based compounds, which could limit the usefulness of nanosilver in medical devices and other medical applications. Furthermore, the EC states, silver can be present in different forms, and it is not clear how these different forms of silver influence its antimicrobial properties, a possible increase of antimicrobial resistance, and the healing process. The EC notes that recent reviews and publications proposed to use a combination of nanosilver and the “usual antibiotics” for the treatment of specific infectious diseases caused by resistant bacteria. The EC requests SCENIHR “to assess whether the use of nanosilver, in particular in medical care and in consumer products could result in additional risks compared to more traditional uses of silver,” and “to assess whether the use of nanosilver to control bacterial growth could result in resistance of micro-organisms.” The deadline for SCENIHR’s opinion is early 2013.

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On December 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) posted an item on its Science Blog entitled “Respiratory Protection for Workers Handling Engineered Nanoparticles.” The purpose of the blog item is to provide an update on the science and rationale behind NIOSH’s recommendations for the use and selection of respirators against engineered nanoparticles. The article summarizes respirator performance research and respirator selection. Concerning next steps, NIOSH states that, while its research to date has been done in laboratory settings, using filtration test systems and manikins under aggressive test conditions, further research is needed in field settings and using human test subjects.  According to NIOSH, “[w]ell-designed studies on face seal leakage of nanoparticles, especially workplace protection factor (WPF) studies that validate assigned protection factor (APF) levels for respirators against nanoparticles will be important,” and such studies are already underway.

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The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it is conditionally registering a pesticide product containing nanosilver as a new active ingredient. HeiQ AGS-20 is a silver-based antimicrobial pesticide product approved for use as a preservative for textiles.  The final registration is not yet in the docket.  We believe, but cannot confirm, the final registration is largely similar to the draft proposed registration issued last year. As members of the nano community know well, this is very good news and demonstrates that EPA is prepared to make regulatory decisions involving nanotechnology, even where, as here, they are likely to inspire controversy.

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