Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On January 19, 2010, the National Institute for Occupational Safety and Health (NIOSH) announced three new peer-reviewed articles co-authored by NIOSH researchers. According to NIOSH, the articles report findings and conclusions from studies that examined issues related to potential occupational exposure to engineered nanomaterials. Two articles in the Journal of Occupational and Environmental Hygiene report on the design and application of the nanomaterial emission assessment technique, which was developed by the NIOSH nanotechnology field evaluation team. Part A describes the technique (Journal of Occupational and Environmental Hygiene, 7:127-132), while Part B discusses findings from use of the technique at 12 facilities. NIOSH states that the results summarized in Part B “demonstrated that the technique is useful in identifying and evaluating sources of nanomaterial emissions, and for evaluating engineering controls intended to minimize emissions and reduce exposures” (Journal of Occupational and Environmental Hygiene, 7:163-176). The third article, highlighted as a “featured research” paper in EHP, examines the potential for occupational exposure to engineered carbon-based nanomaterials in environmental laboratory studies. The article cautions that under some conditions, engineered nanomaterials can become airborne when mixed in solution by sonication.

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On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.

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On January 8, 2010, the U.S. Environmental Protection Agency (EPA) extended until February 8, 2010, the comment period for its November 6, 2009, proposed significant new use rules (SNUR) for multi-walled carbon nanotubes (CNT) and single-walled CNTs.  According to the January 8, 2010, notice, EPA received a request to extend the comment period.  On December 1, 2009, the U.S. World Trade Organization (WTO) Technical Barriers to Trade (TBT) Inquiry Point at the National Institute of Standards and Technology (NIST), on behalf of the European Economic Community (EEC) WTO TBT Enquiry Point, submitted a request to extend the comment period. According to the request, “the European Communities are currently reviewing the draft regulation,” and request that the comment deadline be extended. According to Charles Auer, formerly the Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) and now affiliated with Bergeson & Campbell, P.C., this is the first request he is aware of from the EEC TBT Enquiry Point to OPPT. Auer noted that the EEC is not necessarily raising a trade concern, but may simply want to know the scope of the proposed regulation.

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In a December 16, 2009, letter, three members of the Wisconsin Assembly requested that a Legislative Council study be conducted on the feasibility of creating a nanotechnology registry and the development of subsequent legislation to monitor the use, manufacture, and disposal of nanomaterials in Wisconsin. The letter, signed by State Representatives Terese Berceau (D), Chuck Benedict (D), and Penny Bernard Schaber (D), notes that entities manufacturing or using nanomaterials in Wisconsin are not required by state or federal regulation to identify materials they are using, how they transport and dispose of them, or where such work is taking place. According to the letter, data gaps present “serious concerns” to first responders and public agencies responsible for addressing health consequences or releases into air or water. The letter states: “The development of a registry in partnership with science, business, and the public sector -- and which enhances the economic development of our state -- is our ultimate goal.”

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Last month, Bayer Material Science (BMS) announced that it derived an occupational exposure limit (OEL) of 0.05 milligrams per cubic meter (mg/m³) for Baytubes, BMS multi-wall carbon nanotubes. According to BMS, “[t]he latest results of sub-chronic inhalation studies support the conclusion that Baytubes act like poorly soluble particles.” BMS derived the OEL based on previous single and recent repeated inhalation studies. BMS states: “All relevant information are now included in the updated Safety Data Sheet and will further ensure that our customers work safely with our Baytubes.”

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The National Institute for Occupational Safety and Health (NIOSH) announced that it will hold a conference entitled “Nanomaterials and Worker Health:  Medical Surveillance, Exposure Registries, and Epidemiologic Research,” on July 21-23, 2010, at the Keystone Resort and Conference Center in Keystone, Colorado. According to NIOSH, the goal of the conference is to identify gaps in information and address questions focusing on occupational health surveillance, exposure registries, and epidemiologic research involving nanotechnology workers.  The conference will include invited and submitted papers, breakout sessions to allow for small group discussions, and poster presentation.

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The Silver Nanotechnology Working Group (SNWG) issued a press release regarding its presentation to the U.S. Environmental Protection Agency’s (EPA) Scientific Advisory Panel (SAP) at its November 3-6, 2009, meeting. EPA asked the SAP “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” According to EPA, companies with an interest in marketing products that contain nanosilver and/or other nanometals or nanometal oxides as pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) have approached the Office of Pesticide Programs (OPP) seeking product registration. SNWG’s analysis included the key conclusions that nanosilver is not a new material and that EPA has “safely and successfully” regulated nanosilver products for decades.

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On November 13, 2009, the National Institute for Occupational Safety and Health (NIOSH) released two nanotechnology publications. NOISH posted a document entitled Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center, Project Updates for 2007 and 2008. The Report updates the February 2007 version, which described the progress of the NIOSH Nanotechnology Research Center (NTRC) since its inception in 2004 through 2006. In the November 2009 Report, NIOSH describes program accomplishments achieved in 2007 and 2008. NIOSH states that the NTRC has, with limited resources, continued to make contributions to all the steps in the continuum from hazard identification to risk management. The second document, entitled Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge Gaps, updates the September 2005 Strategic Plan using knowledge gained from results of ongoing research as described in the 2007 report Progress Toward Safe Nanotechnology in the Workplace: A Report from the NIOSH Nanotechnology Research Center and the 2009 update. NIOSH states that the Strategic Plan for the nanotechnology program is the roadmap it is using to advance knowledge about the implications and applications of nanomaterials.

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On November 11, 2009, the European Commission (EC) began a public consultation to receive input from all people and organizations involved or interested in nanosciences and nanotechnologies research in Europe, including researchers, policy makers, industry, media, and civil society organizations. The EC adopted on February 7, 2008, a Recommendation for a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, followed on September 26, 2008, by Council Conclusions on Responsible Nanosciences and Nanotechnologies. Both documents suggested that the EC Recommendation and Code of Conduct should be revised after two years. The EC intends to make these revisions in February 2010, and states that the results of the consultation will contribute to that. The Code of Conduct is intended to frame future research development within a set of general principles on which member states are invited to take concrete action to ensure that nanotechnologies are developed in a safe manner. The online consultation ends on January 3, 2010.

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