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

On May 14, 2013, COWI announced that it was commissioned by the Danish Environmental Protection Agency (EPA) to assess the impacts of nanomaterials on Denmark’s environment. According to COWI, it will perform detailed risk assessments for ten different nanomaterials, including nanotitantium dioxide, nanosilver, nanocopper, and carbon nanotubes. A spokesperson stated that COWI will chart the lifecycle of the materials and examine what substances are released into the environment during various stages. COWI will extrapolate its findings to provide an overall assessment of risks to the environment posed by nanomaterials. According to the spokesperson, at a later stage, the findings could be used as a basis for determining the need for new -risk-reduction measures. The spokesperson noted that COWI was not charged with making recommendations for legislative action, however. A separate project will examine the risks posed by nanomaterials in consumer products. 

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On May 9, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a significant new use rule (SNUR) for premanufacture notice (PMN) substance P-12-44, which is identified as “functionalized multi-walled carbon nanotubes.” According to the Federal Register notice, “[t]he PMN states that the generic (non-confidential) use of the substance is as an additive for rubber and batteries.” EPA states that it determined that “use of the substance other than as described in the PMN; manufacturing, processing, or use in a powder form; or any use of the substance resulting in surface water releases may cause serious health effects or significant adverse environmental effects.” EPA believes the results of the following tests would help characterize the health and environmental effects of the PMN substance: (1) A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a post-exposure observation period of up to three months, bronchoalveolar lavage fluid analysis, particle size distribution information and other toxicologically relevant properties, data on histopathology of pulmonary and ex-pulmonary organs/tissues (cardiovascular, central nervous system, liver, kidney, etc.), pulmonary deposition (lung burden), clearance half-life (biopersistence) and translocation of the test material, and a determination of cardiovascular toxicity; (2) analysis by Scanning Transmission Electron Microscopy, Transmission Electron Microscopy, or Scanning Electron Microscopy of number of walls (range and average), tube ends (open, capped, circular, other), tube width/diameter (measure inner and outer diameters or range), tube length (range) including a description of any deformities found in the tubes (bumps, branching, gaps, etc.); (3) percent (range) of functional groups found on the tubes (include the method of determination); and (4) particle size determined by count not by weight or volume (preferably using Scanning Transmission Electron Microscopy). The rule is effective on July 8, 2013.

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The Ministry of Ecology, Sustainable Development and Energy recently announced that it has extended the deadline for declaring substances with nanoparticle status to June 30, 2013. According to the Ministry, it received 1,991 declarations from 457 companies by the original deadline of April 30, 2013. The Ministry states that, given the “diversity of actors covered by the declaration requirement, and at the request of several industries,” for the first reporting year, it will grant a two-month extension.

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On May 15, 2013, Lynn L. Bergeson will participate in a U.S. Department of Defense (DOD) webinar on “Sustainable Chemicals and Materials for Defense Forum.” Bergeson will provide an overview of the U.S. Environmental Protection Agency’s (EPA) proposed significant new use rules for carbon nanomaterials and biobased chemicals/new chemical exposure limits. The webinar is open to interested stakeholders, who should contact Joey Skoloda for more information.

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On April 11-12, 2013, the Netherlands Ministry of Infrastructure and the Environment hosted an invitation-only conference entitled “Building Blocks for Completing EU Regulation of Nanomaterials.” The conference was intended to identify areas where current European Union (EU) legislation on nanomaterials is insufficient. Participants include representatives from Member States, the European Commission (EC), European Parliament (EP), industry, and a number of non-governmental organizations. According to the April 29, 2013, Chairman’s Report, during the meeting, many participants “considered that databases or registries will be indispensable for gathering the necessary information on (products with) nanomaterials.” While France has already created a national registry, and other Member States, such as Denmark and Belgium, have taken steps towards creating their own, participants “agreed that a[n] EU-registration on nanomaterials is preferred over a series of varying national databases,” which could “create[] more problems than solutions in improving a harmonised European policy on nanomaterials.” The Chairman’s Report states that an EC official noted that “the main problem on the table is to define the level of information on nanomaterials that is required.” According to the Report, the current EC “(which will be in office until the second half of 2014) is unlikely to take a decision on setting up a community-wide EU-database for (products with) nanomaterials.” Industry participants acknowledged that an EU-wide registry could increase public confidence in the safety of nanomaterials, but expressed their concern that a registry could also stigmatize nanoproducts and increase the costs for small- and medium-sized enterprises. The Majority Agreements states: “There is a need to further discuss the goals, costs/benefits and outcome of a register of (products with) nanomaterials. Such discussion should address:

• Public concern;
• Consumers choice;
• Traceability;
• Information (for authorities, in the supply chain, for consumers); and
• Proportionality, etc.

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On April 30, 2013, the U.S. Environmental Protection Agency (EPA) Design for the Environment (DfE) announced the availability of the final report entitled Application of Life-Cycle Assessment to Nanoscale Technology: Lithium-ion Batteries for Electric Vehicles. The life-cycle assessment (LCA) was conducted by the DfE/Office of Research and Development (ORD) Li-ion Batteries and Nanotechnology Partnership. The Partnership conducted a screening-level LCA of currently manufactured lithium-ion (Li-ion) battery technologies for electric vehicles, and a next generation battery component that uses single-walled carbon nanotube technology. EPA states that the study demonstrates how the life-cycle impacts of an emerging technology and novel application of nanomaterials (i.e., the single-walled carbon nanotube technology anode) can be assessed before the technology is mature, and provides a benchmark for future LCAs of this technology. The final report’s key results and conclusions state: “In addition, the SWCNT nanotechnology applications assessed show promise for improving the energy density and ultimate performance of the Li-ion batteries in vehicles. However, the energy needed to produce these anodes in these early stages of development is significant (i.e., may outweigh potential energy efficiency benefits in the use stage). Over time, if researchers focus on reducing the energy intensity of the manufacturing process before commercialization, the overall environmental profile of the technology has the potential to improve dramatically.”

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An April 26, 2013, USA Today article entitled “CDC sets carbon nanotech safety guidelines” reports on the National Institute of Occupational Safety and Health (NIOSH) Current Intelligence Bulletin (CIB) 65, Occupational Exposure to Carbon Nanotubes and Nanofibers.  The article includes comments from Andrew Maynard, Chair of Environmental Health Sciences at the University of Michigan,  Todd Kuiken with the Project on Emerging Nanotechnologies at the Woodrow Wilson Center for International Scholars, and Lynn L. Bergeson, Managing Director of Bergeson & Campbell, P.C. and a board member of the NanoBusiness Commercialization Association.

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On April 24, 2013, the National Institute for Occupational Safety and Health (NIOSH) released Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers, which includes a proposed recommended exposure limit (REL) that is significantly lower than that in the 2010 draft. NIOSH issues Current Intelligence Bulletins (CIB) to disseminate new scientific information about occupational hazards. CIB 65 reviews animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of carbon nanotubes and carbon nanofibers; provides a quantitative risk assessment based on animal dose-response data; proposes a REL of 1.0 microgram per cubic meter (µg/m³) of elemental carbon as a respirable mass 8-hour time-weighted average concentration; and describes strategies for controlling workplace exposures and implementing a medical surveillance program. NIOSH notes that in the 2010 draft of this CIB, it indicated that “risks could occur with exposures less than 1 μg/m³ but that the analytic limit of quantification was 7 μg/m³.” Based on subsequent improvements in sampling and analytic methods, NIOSH states that, in the final CIB, it is now recommending an exposure limit at the current analytical limit of quantification of 1 μg/m³. According to NIOSH, the REL “is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of [carbon nanotubes] may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.” NIOSH notes that, just prior to the release of CIB 65, it reported preliminary findings from a new laboratory study in which mice were exposed by inhalation to multi-walled carbon nanotubes. NIOSH states that the results of the study indicate that multi-walled carbon nanotubes can increase the risk of cancer in mice exposed to a known carcinogen. According to the CIB, NIOSH is conducting additional research to learn more about worker exposures and the potential occupational health risks associated with exposure to multi-walled carbon nanotubes and other types of carbon nanotubes and carbon nanofibers. NIOSH states that, as results from its research become available, it will reassess its recommendations and make appropriate revisions as needed.

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The National Research Council (NRC) announced on April 23, 2013, that its second triennial review of the National Nanotechnology Initiative (NNI) identified five “cross-cutting, high-priority areas for focus and improvement for NNI going forward”:

• Improve information gathering and communication at the project level;
• Develop and implement interagency plans for focused areas;
• Rework the NNI website to serve better the diversity of stakeholder groups;
• Take advantage of new technologies for data collection and analysis; and
• Identify, share, and implement best practices, especially relating to technology transfer and commercialization.

In its report, the NRC assesses NNI’s role in maximizing opportunities to transfer selected technologies to the private sector and suggests improvements and new mechanisms intended to foster technology transfer. The NRC evaluates the suitability of current procedures and criteria to determine progress toward NNI goals, and recommends “explicit definitions of success for and metrics associated with meeting those goals.” The NRC also reviews the NNI’s management and coordination of nanotechnology research across participating federal agencies.

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The Swedish Chemicals Agency (KemI) published an April draft proposal to amend the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to ensure the safe handling of nanomaterials. The draft proposal would adopt the October 2011 European Commission recommendation on the definition of nanomaterial. It would require manufacturers and importers of a nanomaterial, either on its own or in one or more mixture(s), in quantities of ten kg or more per year, to register. The obligation to register on-site isolated intermediates or transported intermediates that fulfill the definition of nanomaterials would apply to any manufacturer of the nanomaterial intermediate in quantities of ten kg or more per year. Producers or importers of articles containing nanomaterials would be required to notify the European Chemicals Agency if the nanomaterial is present in those articles in quantities over ten kg per producer or importer per year.

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On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act (S. 696), which would reform the Toxic Substances Control Act (TSCA) and is identical to legislation (S. 847) reported favorably out of the Senate Environment and Public Works Committee on a party-line vote in the 112th Congress. While the bill does not specifically mention nanomaterials, it defines “special substance characteristic”:

(A) IN GENERAL. -- The term ‘special substance characteristic’ means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic.

(B) CONSIDERATIONS. -- In determining the existence of special substance characteristics, the Administrator may consider --

(i) size or size distribution;

(ii) shape and surface structure;

(iii) reactivity; and

(iv) any other properties that may significantly affect the risks posed.

It is now expected that Senator David Vitter (R-LA), ranking minority member of the Committee, will introduce his version of a TSCA reform bill, a possibility that has been discussed in the trade press for months. More information is available in Bergeson & Campbell, P.C.’s April 11, 2013, memorandum.

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The Nanotechnology Industries Association (NIA) has announced that a new version of its website is now online and available at http://www.nanotechia.org. NIA redesigned the website to serve its members better while also communicating more effectively with the public about the NIA’s activities. The new website better reflects the various sectors where the NIA is present and accurately describes the services offered to members. NIA is a sector-independent, responsible voice for the industrial nanotechnologies supply chains. It supports the ongoing innovation and commercialization of the next generation of technologies and promotes their safe and reliable advancement.

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The U.S. Department of Agriculture (USDA) published a notice on April 8, 2013, withdrawing its April 1, 2013, final rule concerning the designation of product categories for federal procurement. According to the USDA, it is withdrawing the final rulemaking, which amended the guidelines for designating biobased products for federal procurement, because it published the final rule prematurely “due to an oversight in the development process.” The notice states that USDA’s Office of Procurement and Property Management “anticipates republishing the rulemaking in the coming months.”

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The Danish Environmental Protection Agency (EPA) published on March 20, 2013, a proposal for technical information requirements for nanomaterials. The Danish EPA states that its proposal may be used in legislation concerning nanomaterials, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The Danish EPA reviewed information requirement recommendations from expert groups, associations, and authorities. According to the Danish EPA, the proposed information requirement scheme is based on the REACH methodology, i.e., a stepwise approach requiring more information at higher tonnage levels. The Danish EPA notes that the proposal “should not necessarily be seen as a proposal for updating REACH, as it could also be put forward as a stand-alone scheme for nanomaterials and used in relation to adapting other existing legislation, or it could be used for guiding.”

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In an April 1, 2013, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement. The amendments add eight sections to designate product categories within which biobased products will be afforded federal procurement preference: aircraft and boat cleaners; automotive care products; engine crankcase oil; gasoline fuel additives; metal cleaners and corrosion removers; microbial cleaning products; paint removers; and water turbine bearing oils. The amendments also add the proposed countertops subcategory to the existing composite panels product category. USDA also established minimum biobased contents for each of these product categories and subcategories. In addition, USDA is officially changing the term “item” to product category. The amendments will take effect on May 1, 2013.

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On March 20, 2013, five German agencies published a report entitled Nanotechnology -- Health and Environmental Risks of Nanomaterials, which includes a joint set of recommendations for future safety assessments of nanomaterials. Under a joint research strategy set up in 2007, over 80 research projects on nanomaterials were reviewed. The report includes recommendations to:

• Develop adequate measurement methods for risk assessment;
• Develop reference materials for exposure assessment and studies into the effects of nanomaterials on humans and the environment;
• Validate and harmonize test and evaluation strategies “in a national and international context” to allow results to be compared;
• Develop screening tests for adverse health and environmental risks at an early stage of material innovation;
• Develop ideas for labeling single nanomaterials; and
• Work on grouping nanomaterials based on their properties to reduce the number of complex single investigations.

The report was prepared by the Federal Institute for Risk Assessment, Federal Environment Agency, Federal Institute for Occupational Safety and Health, Federal Institute for Materials Research and Testing, and Physikalisch-Technische Bundesanstalt.

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This week, the House Energy and Commerce Committee released the first of five bipartisan white papers that explore important policy implications related to continued implementation of the Renewable Fuel Standard (RFS). The white papers are intended to solicit input and stimulate debate in several areas:  infrastructure, fuel compatibility, blending, economics, and environmental issues. Each paper will provide a detailed policy analysis on one area and then outline a series of questions intended to engage key stakeholders on that issue.

This first white paper, The Blend Wall and Fuel Compatibility Issues, focuses on one of the most pressing and complicated policy challenges facing proponents and opponents of biofuels. The paper recognizes a changed fuels refining environment from 2007, where fuel demand has fallen dramatically and 10 percent ethanol blends (the conventional ethanol blend percentage) are rapidly approaching saturation in the fuel pool. It discusses various aspects of mid-level ethanol blends (E15, E85), which have the ability to introduce higher volumes of biofuels than conventional blend levels. Some key questions posed at the end of the white paper for biofuels stakeholders relate to the feasibility of mid-level ethanol blends, the marketing and mis-fueling challenges to mid-level blends, the economics of the Blend Wall, and the intersection of new Corporate Average Fuel Economy (CAFE) vehicle standards and the RFS. The Committee asks stakeholders to respond to the first paper by April 5, 2013.

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The Industry Consortium for Environmental Measurement of Nanomaterials (ICEMN) announced today the release of a series of articles to serve as a practical guide for state and federal regulatory agencies tasked with measuring engineered nanomaterials in the environment. The articles, published in the March 2013 special issue of Environmental Engineering Sciences, were prepared by academic and industrial scientists from ICEMN and focus on the techniques and issues around nanomaterial measurement in water, air, and soil. The series of articles collates sources of primary literature and summarizes secondary literature on experimental evidence of release of nanomaterials from nano-enabled products and the capture of nanomaterials in wastewater treatment, and reviews the methodological and measurement strategy issues involved in quantifying engineered nanomaterials in the environment.

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The March 16, 2013, Canada Gazette includes a significant new activity (SNAc) notice for cobalt iron manganese oxide, carboxylic acid-modified, which the notice states is not included on the Domestic Substances List (DSL). The notice defines SNAc as:

(a) [A]ny use where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 100 kg per calendar year other than for a use described in paragraph (b); or

(b) [T]he use as an ink additive in commercial or industrial settings where the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 1,000 kg per calendar year.

The notice specifies data that must be provided to Canada 90 days before commencement of the proposed SNAc. Canada notes that, under the Canadian Environmental Protection Act, 1999, in circumstances where a SNAc notice is issued for a new substance, “it is the responsibility of every person who transfers the physical possession or control of the substance to notify all persons to whom the possession or control is transferred of the obligation to comply with the Significant New Activity Notice and of the obligation to notify the Minister of the Environment of any new activity and all other information as described in the Notice.” Users are responsible for being aware of and complying with the SNAc notice and submitting a SNAc notification prior to the commencement of a SNAc associated with the substance.

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On March 11, 2013, the European Union’s (EU) FP7 project on Mitigation of Risk and Control of Exposure in Nanotechnology-based Inks and Pigments (nanoMICEX) announced publication of its first newsletter. According to nanoMICEX, project participants have been working to improve the conditions for workers in the inks and pigments industry, and the newsletter describes the latest news and developments. The newsletter reports on the March 2012 kick-off meeting, where participants discussed which engineered nanoparticles to characterize, how best to carry out hazard and exposure assessments, and ways in which risks will be assessed and managed.  The newsletter describes work that has been done to date, while more in-depth articles by nanoMICEX partners provide information on how the partners are ensuring the safety of workers within the industry. The newsletter includes a timeline of upcoming activities in the next six months, including publication of the next newsletter in September 2013.

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On February 22, 2013, Empa announced the availability of a study prepared on behalf of Switzerland’s Federal Office for the Environment (FOEN) entitled Human and Ecotoxicity of Synthetic Nanomaterials: Initial Insights for Major Accident Prevention. The study is intended to address whether new criteria for the determination of the quantity thresholds in the Ordinance on Protection against Major Accidents (OMA) may result from the accident potential or possible new hypothetical accident scenarios related to the human and ecotoxicity of synthetic nanomaterials. According to the study, data available at the present time are very limited and are inadequate to allow general conclusions to be drawn. Nonetheless, the study states, “initial insights for major accident prevention could be won, and a perspective on important pending questions given.” FOEN’s objective is to encourage research institutions and industry to take up these questions. FOEN “will continue to follow the national and international developments in this field, to put it in a position to introduce the necessary measures when necessary.”

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The United States Department of Agriculture (USDA) posted a notice on its website concerning the BioPreferred Program. According to USDA, due to the absence of funding in the Farm Bill extension legislation, USDA has suspended the processing of applications for voluntary certification of biobased products. USDA states that it “will continue limited activities related to the Federal procurement preference program, such as adding products to the BioPreferred catalog, as staff resources allow. All existing biobased product label certifications (900 'USDA Certified Biobased Products' as of December 31, 2012) are and will remain valid.” Since 2002, USDA has designated some 89 categories representing 9,000 biobased products, all of which qualify for federal sustainable procurement standards.

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On February 25, 2013, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances that were the subject of premanufacture notices (PMN). EPA notes that the proposed SNURs include 14 PMN substances whose reported chemical names include the term “carbon nanotube” (CNT) or “carbon nanofibers.”  If issued in final, the SNURs would require persons who intend to manufacture, import, or process the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA states that the required notification would provide it with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due April 26, 2013.

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On January 23, 2013, Representative Mike Honda (D-CA) reintroduced the Nanotechnology Advancement and New Opportunities (NANO) Act (H.R.394). Honda described the Act as a comprehensive bill intended to promote the development and responsible stewardship of nanotechnology in the U.S. Honda based the legislation on the recommendations of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts convened by Honda and then-California State Controller Steve Westly during 2005. The bill includes recommendations from the Blue Ribbon Task Force for ways to promote the development and commercialization of nanotechnology; requires the development of a nanotechnology research strategy that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology; and includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. Honda introduced similar legislation in the 112th (H.R. 2749), 111th (H.R. 820), and 110th (H.R. 3235) Congresses. None of the bills made it out of subcommittee.

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The Organization for Economic Cooperation and Development (OECD) published on February 14, 2013, the updated Current Developments in Delegations on the Safety of Manufactured Nanomaterials -- Tour de Table. The purpose of the Tour de Table is to allow each delegation the opportunity to describe recent or planned national initiatives and/or events related to the safety of manufactured nanomaterials. According to OECD, this will facilitate the implementation of the projects of the WPMN by allowing delegations to share their experiences and preoccupations with respect to safety, and will identify opportunities for future co-operation and co-ordination.

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The European Commission (EC) announced on February 5, 2013, that it completed its five-year review of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The pre-publication version of the EC’s report states that the EC “will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers.  If appropriate the Commission will come forward with a draft implementing act by December 2013.” The pre-publication version of the staff working paper specifically recommends that, if REACH needs amending “for other reasons,” then “consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU.”

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The Occupational Safety and Health Administration (OSHA) recently published a fact sheet entitled Working Safely with Nanomaterials. OSHA notes that workers who use nanotechnology in research or production processes may be exposed to nanomaterials through inhalation, skin contact, or ingestion. OSHA intends the fact sheet to provide “basic information to workers and employers on the most current understanding of potential hazards associated with this rapidly-developing technology and highlight[] measures to control exposure to nanomaterials in the workplace.” According to the fact sheet, information and training provided to workers should include:

• Identification of nanomaterials the employer uses and the processes in which they are used;
• Results from any exposure assessments conducted at the work site;
• Identification of engineering and administrative controls and personal protective equipment (PPE) to reduce exposure to nanomaterials;
• The use and limitations of PPE; and
• Emergency measures to take in the event of a nanomaterial spill or release.

OSHA states that there are few occupational exposure limits specific to nanomaterials. According to OSHA, because certain nanoparticles may be more hazardous than larger particles of the same substance, existing occupational exposure limits for a substance may not provide adequate protection from nanoparticles of the same substance. OSHA notes the following specific exposure limits:

• OSHA recommends that worker exposure to respirable carbon nanotubes and carbon nanofibers not exceed 7.0 micrograms per cubic meter (μg/m³) as an 8-hour time-weighted average, based on the National Institute for Occupational Safety and Health (NIOSH) proposed Recommended Exposure Limit (REL); and
• OSHA recommends that worker exposure to nanoscale particles of titanium dioxide (TiO₂) not exceed NIOSH’s 0.3 milligrams per cubic meter (mg/m³) REL. By contrast, NIOSH’s REL for fine-sized TiO₂ (particle size greater than 100 nm) is 2.4 mg/m³.

OSHA suggests that, because exposure limits for other nanomaterials do not exist yet, employers should minimize worker exposure by using the hazard control measures and best practices identified in the fact sheet and in the references noted.

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The U.S. Environmental Protection Agency announced on January 31, 2013, the proposed 2013 percentage standards for four fuel categories that are part of the Renewable Fuel Standard Program. Once EPA publishes the proposed standards in the Federal Register, there will be a 45-day comment period. Under the Energy Independence and Security Act (EISA), the annual renewable fuel volume targets steadily increase to an overall level of 36 billion gallons in 2022. To meet this goal, EPA calculates a percentage-based standard, and, based on the standard, each refiner and importer determines the minimum volume of renewable fuel that it must ensure is used in its transportation fuel. The proposed 2013 overall volumes and standards are:

• Biomass-based diesel (1.28 billion gallons; 1.12 percent);
• Advanced biofuels (2.75 billion gallons; 1.60 percent);
• Cellulosic biofuels (14 million gallons; 0.008 percent); and
• Total renewable fuels (16.55 billion gallons; 9.63 percent).

EPA notes that, for 2013, it is proposing to implement EISA’s requirement to blend more than 1.35 billion gallons of renewable fuels over the amount mandated for 2012.

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On January 25, 2013, the U.S. Court of Appeals for the District of Columbia Circuit vacated the U.S. Environmental Protection Agency’s (EPA) 2012 cellulosic biofuel requirements under the renewable fuel standard. American Petroleum Institute v. EPA, D.C. Cir., No. 12-1139. In its January 2012 final rule, EPA projected that 8.65 million gallons of cellulosic biofuel would be produced in 2012, and determined that a reduction in the volume of total advanced biofuels was unnecessary because other kinds of advanced biofuels could make up for the shortfall. The American Petroleum Institute (API) filed suit, challenging EPA’s 2012 projection for cellulosic biofuel and its refusal to reduce the volume of total advanced biofuels for 2012. While the court rejected API’s argument that EPA failed to justify its determination not to reduce the applicable advanced biofuels volume, the three-judge panel unanimously agreed that “because EPA’s methodology for making its cellulosic biofuel projection did not take neutral aim at accuracy, it was an unreasonable exercise of agency discretion.” The court vacated that aspect of the 2012 rule and remanded it to EPA. An EPA spokesperson stated that EPA is still reviewing the court’s decision.

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Oral arguments were held on January 16, 2013, in the Natural Resources Defense Council’s (NRDC) case challenging the U.S. Environmental Protection Agency’s (EPA) conditional registration of HeiQ AGS-20, a nanosilver product. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California). During oral arguments, EPA maintained that NRDC lacks standing to challenge the conditional registration. The judges appeared to reject EPA’s argument, suggesting that NRDC could prevail because of the low bar for establishing standing to challenge a rulemaking. The judges seemed less persuaded by NRDC’s argument that EPA erred in choosing three-year-olds rather than nine-month-olds as the most vulnerable subpopulation on which to base risk values. According to NRDC, EPA should have used infants, who are more likely to chew on textiles and could have higher exposures. EPA responded that EPA has a long-standing practice of using three-year-olds in risk assessments with similar exposure patterns to AGS-20, and that its use of three-year-olds was supported by leaching studies. NRDC further argued that EPA failed to consider the risk of aggregate exposures from other nanosilver products on the market. EPA responded that it applied uncertainty factors to account for data gaps and that HeiQ must submit more data to obtain a full registration.

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On January 18, 2013, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice seeking comment on the types of hazard identification and risk management research to consider in updating its fiscal years 2013-2016 nanotechnology strategic plan. NIOSH states that it wants to “build on the accomplishments of ongoing research” to “develop strategic research goals and objectives for nanotechnology occupational safety and health research through 2016.” NIOSH previously identified ten critical research areas for nanotechnology research and communication: (1) toxicity and internal dose; (2) measurement methods; (3) exposure assessment; (4) epidemiology and surveillance; (5) risk assessment; (6) engineering controls and personal protective equipment; (7) fire and explosion safety; (8) recommendations and guidance; (9) global collaborations; and (10) applications. According to the notice, NIOSH is considering focusing the research goals on five key objectives: (1) increase understanding of new hazards and related health risks to nanomaterial workers; (2) expand understanding of the initial hazard findings on engineered nanomaterials; (3) support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision-makers about hazards, risks, and risk management approaches; (4) support epidemiologic studies for nanomaterial workers, including medical and exposure studies; and (5) assess and promote national adherence with risk management guidance. NIOSH requests public input to address the basis or rationale for priorities that NIOSH should give for studies of toxicity evaluation and/or workplace exposure characterization for engineered nanoparticles, and what rationale can be provided for recommending needs and types of technical and educational guidance materials. Comments are due March 19, 2013.

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On January 9, 2013, the Norwegian Climate and Pollution Agency (Klif) posted a notice concerning the annual update of information and mandatory reporting of quantities for chemicals for 2012 to the Norwegian Product Register. The Product Register is the central register for chemical products in Norway, and there are currently approximately 25,000 products registered. According to Klif’s notice, changes include adding a “NANO box” that registrants should mark if the chemical contains nanomaterials. The January 7, 2013, letter sent to registrants states:

Physical data that may be of significance when assessing the dangerous properties of chemicals must be declared under section 21 of the Norwegian Regulations relating to classification and labelling of dangerous chemicals. Details are given in guidelines on declaration. The definition of nano materials is given in the recommendation of the Commission by 18 October 2011. Registration of substances in nano form in the Product Register will provide better knowledge about where and how nano materials are used. The information will be used by the authorities in their work to protect human health and the environment.

For all your mandatory declared chemicals we ask you to provide information that is already known by the producer about substances on nano scale. This means that if your chemical contains a substance/substances in nano form, you should mark this in the appropriate box on the enclosed list. In addition you have to identify which constituent that is in nano form in the same box. During 2013 you will have to update the composition for all your mandatorily declared chemicals that contain substances in nano form.

Responses are due February 8, 2013.

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The French Ministry of Ecology and Sustainable Development posted a January 8, 2013, memorandum (in French) concerning the annual mandatory reporting of nanomaterials, which took effect January 1, 2013.  Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. The report will be due by May 1 for information about nanoparticle substances produced/imported/distributed during the prior year. A report containing 2012 data will be due by May 1, 2013. The January 8, 2013, memorandum includes a link to a new website for reporting, as well as a link to a frequently asked questions and answers document (both in French).

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On November 21, 2012, Health Canada began a public consultation on a Draft: Guidance Document -- Sunscreen Monograph, which is intended to replace the existing 2006 Sunburn Protectants Monograph. The draft Monograph identifies the permitted ingredients, including nano zinc oxide and nano titanium dioxide; doses; directions and indications for use for these products, which will be required to appear on the product labels; and the recommended supporting test methods. The draft Monograph notes that license holders are expected to continue monitoring and collecting new safety data as they emerge. Applicants are required to keep information for recordkeeping purposes when nano zinc oxide and/or nano titanium dioxide are used in sunscreen products, and this information is required to be made available upon request. Comments are due February 19, 2013.

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The U.S. Environmental Protection Agency (EPA) is scheduled to announce in the January 8, 2013, Federal Register the availability of its 2012 Regulatory Agenda. EPA’s Regulatory Agenda includes the following notice concerning nanoscale materials:

Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials. Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process nanoscale materials for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment. In addition, EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in July 2013.

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On December 20, 2012, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a final rule setting forth EPA’s final decision on the issues for which it granted reconsideration pertaining to its March 21, 2011, final rule entitled “Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units.” The December 20, 2012, rule makes technical corrections to the March 21, 2011, final rule, including clarifying the definition of clean cellulosic biomass (revisions are in red):

 

Clean cellulosic biomass means those residuals that are akin to traditional cellulosic biomass, including, but not limited to: agricultural and forest-derived biomass (e.g., green wood, forest thinnings, clean and unadulterated bark, sawdust, trim, tree harvesting residuals from logging and sawmill materials, hogged fuel, wood pellets, untreated wood pallets); urban wood (e.g., tree trimmings, stumps, and related forest-derived biomass from urban settings); corn stover and other biomass crops used specifically for the production of cellulosic biofuels (e.g., energy cane, other fast growing grasses, byproducts of ethanol natural fermentation processes); bagasse and other crop residues (e.g., peanut shells, vines, orchard trees, hulls, seeds, spent grains, cotton byproducts, corn and peanut production residues, rice milling and grain elevator operation residues); wood collected from forest fire clearance activities, trees and clean wood found in disaster debris, clean biomass from land clearing operations, and clean construction and demolition wood.  These fuels are not secondary materials or solid wastes unless discarded.  Clean biomass is biomass that does not contain contaminants at concentrations not normally associated with virgin biomass materials.

The amended definition will be effective 60 days after publication in the Federal Register.

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The National Institute for Occupational Safety and Health (NIOSH) is scheduled to publish in the December 19, 2012, Federal Register a request for information and comment on silver nanoparticles. According to the notice, NIOSH has initiated an evaluation of the scientific data on silver nanoparticles “to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted.” NIOSH has identified a number of “relevant publications” on silver nanoparticles, and this listing will be available in Docket CDC-2012-0014, at http://www.regulations.gov, once the Federal Register notice is published. NIOSH requests additional information concerning:

1. Published and unpublished reports and findings from in vitro and in vivo toxicity studies with silver nanoparticles;
2. Information on possible health effects observed in workers exposed to silver nanoparticles;
3. Information on workplaces and products in which silver nanoparticles can be found;
4. Description of work tasks and scenarios with a potential for exposure;
5. Information on measurement methods and workplace exposure data; and
6. Information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to silver nanoparticles occur.

Comments will be due 60 days after the notice is published in the Federal Register.

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U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed on November 30, 2012, a supplemental rule associated with the Renewable Fuel Standard (RFS) Program. The final rule contains a lifecycle greenhouse gas (GHG) analysis for grain sorghum ethanol and a regulatory determination that grain sorghum ethanol qualifies as a renewable fuel under the RFS Program. According to the rule, EPA’s analysis indicates that ethanol made from grain sorghum at dry mill facilities that use natural gas for process energy meets the lifecycle GHG emissions reduction threshold of 20 percent compared to the baseline petroleum fuel it would replace, and therefore qualifies as renewable fuel.  The rule also includes EPA’s regulatory determination that grain sorghum ethanol produced at dry mill facilities, using specified forms of biogas for both process energy and most electricity production, has lifecycle GHG emission reductions of more than 50 percent compared to the baseline petroleum fuel it would replace, and that such grain sorghum ethanol qualifies as an advanced biofuel under the RFS Program. The rule will take effect when it is published in the Federal Register.

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In a November 21, 2012, Canada Gazette notice, Canada amended the Domestic Substances List (DSL). The amendments include the addition of cellulose, hydrogen sulphate, sodium salt, obtained from sulphuric acid hydrolysis of the bleached pulp, with the substance having the following characteristics:

• (a) Nominal length of 100 ± 50 nanometres;
• (b) Cross section dimension less than or equal to 10 nanometres; and
• (c) Sulphur content of greater than or equal to 0.5 percent and less than or equal to 1.0 percent by weight.

Canada added the substance with substance identity number 91343, rather than a Chemical Abstracts Service (CAS) Registry Number. Substances on the DSL do not require notification unless they are proposed for a significant new activity (SNAc) as indicated on the DSL. Substances not appearing on the DSL are considered to be new to Canada and are subject to notification.

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Environmental Law Network International’s (ELNI) recent issue of elni Review includes an article entitled “Law and innovation in the context of nanomaterials: Barriers to sustainable development? Results of an empirical study,” which examines to what degree the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation promotes innovations for sustainability through nanomaterials. The authors surveyed 37 companies based in Germany that manufacture and/or use nanomaterials to determine how REACH affected their approach. Issues addressed included the relationships between substance risks and innovation and between REACH and innovation. The authors determined that REACH does not offer sufficient incentives to register nanomaterials and to apply nano-specific safety assessment procedures. In addition, according to the authors, the lack of specific provisions within REACH concerning nanomaterials results in uncertainties in the interpretation of legal concepts and obligations.  The authors offer preliminary conclusions for a possible adaptation of the legal framework for nanomaterials.

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The European Food Safety Authority (EFSA) published in the October 10, 2012, Official Journal of the European Union a call for tender to prepare a background document on the current knowledge in the field of nanotechnology and prepare an inventory of food additives/food contact materials/feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used. According to the tender specifications, the tasks will include:

• Performing an extensive literature search to summarize the knowledge in the field of nanotechnology applied to food and feed;
• Producing inventory lists for each type of application (e.g., food additives, enzymes, flavorings, food contact material, novel foods, feed additives, and pesticides), including at least one inventory list for food additives, one for food contact materials, and one for feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used;
• Reviewing the existing non-European Union (EU) legislation on the authorization of food additives/food contact materials/feed additives application in the area of nanotechnology; and
• Preparing a final report.

The length of the contract will be one year and is not renewable. Responses were due November 23, 2012. EFSA estimates that the contract will be completed in January 2014.

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On November 28, 2012, the Canada-U.S. Regulatory Cooperation Council (RCC) held a webinar to discuss its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to information presented during the webinar, while the U.S. has received 137 notifications concerning nanomaterial substances, Canada has received only 16. While most of the nanomaterial substances notified in the U.S. were inorganic carbon, most of those notified in Canada were mixed metal oxides. During the webinar, both Canadian and U.S. spokespersons noted the difficulty in sharing information, due to confidential business information (CBI) claims. The RCC would like to be able to share information to inform better their regulatory programs and risk assessment/management approaches. This would include:

• General Substance Information: Substance name, company, applications, volumes; and
• Technical Substance Specific Information: Physchem properties, technical studies, and use pattern information.

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

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On November 20, 2012, Lux Research Inc. released a report entitled Bridging the Divide between Demands and Bio-Based Materials, in which the properties and commercial attractiveness of 38 applications and 21 conventional and bio-based polymers were assessed on 13 criteria, with three demand areas promising opportunity, according to Lux. Lux states that materials that fail to connect with end-user demands never reach the commercialization stage. Lux recommends that developers target large, addressable markets, among which the biggest are composites and coatings, industrial manufactured intermediates, and packaging. Lux notes that developers must offer bio-based alternatives at cost parity, offer more bio-based drop-in monomers, and continue to close performance gaps on temperature distortion and brittleness, as well as advance bio-based polymers beyond their reputation as merely “disposable.” Lux urges developers to meet or exceed expectations on cost and performance and be smart during roll-out. Kalib Kersh, a Lux analyst, stated that the U.S. Department of Agriculture (USDA) would expand the market for biobased chemicals if it fulfills its pledge to certify intermediates through its BioPreferred Program. During a recent conference held by the Society for the Commercial Development of Industrial Biotechnology, a USDA spokesperson stated that USDA intends to cover intermediates in its Program.

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The American Fuel & Petrochemical Manufacturers (AFPM) petitioned the U.S. Court of Appeals for the District of Columbia Circuit on November 21, 2012, for review of the U.S. Environmental Protection Agency’s (EPA) 2013 biomass-based diesel renewable fuel requirements. Under EPA’s September 27, 2012, final rule, EPA increased the volume of biomass-based diesel from 1.0 billion to 1.28 billion gallons for calendar year 2013. According to AFPM, a number of factors have surfaced since EPA issued the rule that could result in unintended consequences adversely impacting the domestic refining industry and U.S. consumers. AFPM states that the increase could reduce investment in advanced biofuels that compete with biodiesel and increase carbon emissions.  In addition, AFPM notes, the increase could negatively impact the price and supply of agricultural commodities, since additional biodiesel feedstocks, such as soybean oil, would be required under the rule.

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The presentations from the August 14-16, 2012, “Safe Nano Design: Molecule » Manufacturing » Market” workshop are now available. The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center held the workshop, during which participants provided input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach. The workshop focused on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. A summary of all of the outcomes from each panel discussion is in development. Lynn L. Bergeson was on the Planning Committee for the workshop, and presented remarks.

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The Center for International Environmental Law (CIEL), ClientEarth, and Friends of the Earth Germany (BUND) released on November 13, 2012, a proposal for European Union (EU) legislation to address the risks of nanomaterials. CIEL states that the non-governmental organizations’ (NGO) proposal was prompted by the European Commission’s (EC) October 3, 2012, Communication on the Second Regulatory Review on Nanomaterials. The Communication describes the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program as “the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures” and notes that “more specific requirements for nanomaterials within the framework have proven necessary.” The NGOs maintain that further regulatory action is necessary, and recommend a “nano patch” for REACH, including an obligation for all nanomaterials to be considered distinct from their non-nanoscale counterparts and substantially lower volume thresholds for registration of nanoscale substances. The NGOs also call for an EU-wide registry for all nanomaterials and products on the market.

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BP announced on October 25, 2012, that it canceled its plans to build a commercial-scale cellulosic ethanol plant in Highlands County, Florida, and would instead refocus its U.S. biofuels strategy on research and development and licensing its biofuels technology. BP states that when it announced its plans to build the facility, in 2008, it intended to turn “thousands of acres of energy crops into 36 million gallons per year of cellulosic ethanol.” BP intends to continue to invest in and operate its biofuels research facility in San Diego, California, and a demonstration plant in Jennings, Louisiana, to develop next generation cellulosic biofuel technologies and license them for commercial use.  Under the Energy Independence and Security Act of 2007, one billion gallons of cellulosic biofuel must be included in the U.S. fuel supply in 2013, and 16 billion gallons must be produced by 2022. The statute requires EPA to set the cellulosic biofuel standard each year based on the volume projected to be available during the following year, using Energy Information Administration projections and assessments of production capability from industry. For 2012, EPA projected there would be only 8.65 million gallons of cellulosic biofuel available, short of the 500 million gallons required. EPA has not yet set the standard for 2013.

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On October 19, 2012, the European Comission (EC) began a public consultation on a preliminary opinion entitled Addressing the New Challenges for Risk Assessment. The Inter-Committee Coordination Group of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Consumer Safety (SCCS), and Scientific Committee on Health and Environmental Risks (SCHER) established a joint working group to review risk assessment procedures and new challenges for risk assessment, taking into account both fundamental and practical considerations, and to provide a scientific discussion paper on the issue. According to the preliminary opinion, a number of additional factors, including the need to assess more complex products and processes, e.g., products of nanotechnologies, make a thorough examination of current and potential future methods particularly timely. The preliminary opinion states that research is needed for developing models suitable for predicting the fate of nanomaterials.  Fully new approaches need to be developed, conceptually different from the traditional molecular-based models. The preliminary opinion states that SCENIHR, SCCS, and SCHER “are aware that the most of the proposals described in this discussion paper are not realistically suitable for amending, in the short term, risk assessment procedures for regulatory purposes. However, this discussion paper highlights needs and priorities for research in order to get the objective of higher precision, accuracy and transparency in risk assessment for protecting human and environmental health."  Comments are due November 30, 2012. 

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On October 22, 2012, Safe Work Australia announced the availability of a report entitled Human Health Hazard Assessment and Classification of Carbon Nanotubes, as well as an information sheet on the report. The report recommends that multi-walled carbon nanotubes should be classified as hazardous unless toxicological or other data for specific types imply otherwise. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) prepared the report in support of Safe Work Australia’s Nanotechnology Work Health and Safety Program. NICNAS extensively reviewed the published literature on the toxicity of carbon nanotubes, and concluded that multi-walled carbon nanotubes may cause damage to lungs through prolonged or repeated inhalation exposure. The report recommends classification as hazardous for repeated or prolonged inhalation exposure and for carcinogenicity. For all other endpoints, NICNAS found that carbon nanotubes either were not classified as hazardous, or cannot be classified as insufficient data are available. The information sheet summarizes the key findings from the report and discusses implications for manufacturers, importers, persons in control of a business or undertaking, and workers manufacturing or using products containing carbon nanotubes.

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On October 30, 2012, the European Chemicals Agency (ECHA) will hold a webinar entitled “How to ensure the safe use of nanomaterials under REACH Part I: Characterisation of nanoforms of substances in registration dossiers.” According to ECHA, the webinar will provide information to registrants on the type of information to be included in a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier for a substance with nanoform(s). In addition, on October 17, 2012, ECHA announced publication of a new web page on nanomaterials under REACH and the Classification, Labeling, and Packaging (CLP) regulation. According to ECHA, the page “will provide advice to registrants that wish to register nanomaterials and inform about” ECHA’s latest activities concerning nanomaterials. The web page states that, in October 2012, ECHA created a nanomaterials working group “to discuss scientific and technical questions relevant to REACH and CLP processes and to provide recommendations on strategic issues.” The working group is an informal advisory group consisting of experts from Member States, the European Commission, ECHA, and accredited stakeholder organizations, “with the mandate to ‘Provide informal advice on any scientific and technical issues regarding implementation of REACH and CLP legislation in relation to nanomaterials.’” ECHA states that the working group also “aims to facilitate discussions with industry regarding its experience gained in documenting intrinsic properties of the nano-forms of substances using recent methodologies and its obligations towards fulfilling REACH requirements.”

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On October 5, 2012, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) for potassium titanium oxide, which was previously the subject of a consent order under Section 5(e) of the Toxic Substances Control Act (TSCA). EPA states that, based on test data on the premanufacture notice (PMN) substance and structure activity relationship analysis of test data on analogous respirable, poorly soluble particulates (subcategory titanium dioxide), EPA “identified concerns for lung toxicity and fibrosis in workers exposed to the PMN substance by the inhalation route.” EPA issued the consent order based on a finding that the substance may present an unreasonable risk of injury to human health. The conditions required by the consent order include “[n]o manufacture of the PMN substance with a particle size less than 100 nanometers.” The final SNUR designates as a significant new use the absence of the protective measures required by the consent order. According to the SNUR, EPA determined that a 90-day inhalation toxicity test with special attention to histopathology of the lung tissues and to various parameters of the broncoalveolar lavage fluid would help characterize the human health effects of the PMN substance. The SNUR will be effective on December 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due November 5, 2012.

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The Canada-U.S. Regulatory Cooperation Council (RCC) will hold a webinar on November 28, 2012, on its RCC Nanotechnology Work Plan. Canada and the U.S. created the RCC to align better their regulatory approaches in a number of areas, including nanotechnology. According to the U.S. Environmental Protection Agency (EPA), the purpose of the RCC’s nanotechnology initiative is to increase, where possible, regulatory transparency and coordination between the U.S. and Canada respecting nanomaterials. The Nanotechnology Work Plan includes specific objectives, deliverables, and milestones for tangible progress within the RCC’s two-year mandate. During the November 28, 2012, webinar, RCC will provide additional background information, as well as updates on ongoing activities under the Nanotechnology Work Plan. Stakeholders should confirm their webinar attendance no later than October 25, 2012.

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During the Third International Conference on Chemicals Management (ICCM3), which was held September 17-21, 2012, participants agreed to add the measures concerning nanotechnologies and manufactured nanomaterials to the Strategic Approach to International Chemicals Management (SAICM) Global Plan of Action. The measures include “exploring the development of registers/inventories and/or market assessment activities of manufactured nanomaterials,” and “promoting the availability of information on the presence of manufactured nanomaterials within the product supply chain and throughout the life cycle, which could include possible labelling, consistent with relevant international obligations, and/or other forms of guidance relating to consumer products containing manufactured nanomaterials.” Participants also agreed to a resolution to continue work on manufactured nanomaterials as an “emerging policy issue” under SAICM, and to develop international technical and regulatory guidance and training materials for their sound management.  The Resolution invites the United Nations (UN) Committees of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to review the applicability of the GHS criteria to manufactured nanomaterials and, if necessary, to prepare a work plan for adapting them.

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On October 3, 2012, the European Commission (EC) announced its adoption of a Communication on the Second Regulatory Review on Nanomaterials, which assesses the adequacy and implementation of European Union (EU) legislation for nanomaterials, indicates follow-up actions, and responds to issues raised by the European Parliament (EP), EU Council, and the European Economic and Social Committee. The Communication concludes that “nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not.” Since possible risks are related to specific nanomaterials and specific uses, nanomaterials should be assessed on a case-by-case basis. The Communication states: “Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.” According to the Communication, the EC “remains convinced that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations after 2013.” To improve the availability of information, the EC states that it “will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.”

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Tom Vilsack, Secretary of Agriculture, spoke at the 2012 GreenGov Symposium on September 25, 2012. According to Vilsack, the United States Department of Agriculture (USDA) is working to support the manufacturing industry by increasing the number of biobased products approved for federal purchase. Currently, there are approximately 9,300 BioPreferred products, and USDA intends to make 18,000 BioPreferred products available. Under Executive Order 13,514, federal agencies are required to ensure that 95 percent of new contracts use biobased products when available. Under a February 21, 2012, Presidential Memorandum, the USDA is directed to increase the number of categories of biobased products available for purchase by 50 percent by February 21, 2013. There were 64 categories of biobased products available in February 2012, and Vilsack stated that USDA has increased the number of categories to 77, including lotions and moisturizers, leather, vinyl, rubber care products, and shaving products.

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The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has posted an opinion on zinc oxide, nano-form. SCCS approved the opinion for adoption and it is now open for comment by applicants, national authorities, and other interested parties. SCCS considered whether zinc oxide in its nano-form is safe for use as a UV-filter with a concentration up to 25 percent in cosmetic products. SCCS concluded, on the basis of available evidence, that the use of zinc oxide nanoparticles with the indicated characteristics, at a concentration up to 25 percent as a UV-filter in sunscreens, “can be considered not to pose a risk of adverse effects in humans after dermal application.” SCCS notes that this does not apply to other applications that might lead to inhalation exposure to zinc oxide nanoparticles, such as sprayable products. SCCS states that the use of larger (non-nano) forms of zinc oxide as a UV-filter with a concentration up to 25 percent, as stated in its 2009 clarification, is safe and is not of any additional safety concern compared to the nano-forms assessed in the opinion. Regarding whether SCCS has any further scientific concern about the use of zinc oxide in cosmetic products, SCCS states: “In view of the lung inflammation induced by ZnO particles after inhalation exposure, the use of ZnO in cosmetic products which may result in inhalation is of concern.” SCCS also notes: “Any cosmetic products containing ZnO particles (nano or non-nano) with coatings that can promote dermal penetration will also be of concern.” Comments are due October 22, 2012.

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Under a draft amendment to the Danish Chemicals Act, the Minister of the Environment would have the authority to write a detailed order establishing the rules for a national database of mixtures and articles containing or releasing nanomaterials. The order would also require producers and importers to report products containing or releasing nanomaterials. The information in the database is intended to form the basis of an evaluation of whether the content of nanomaterials in products on the Danish market poses a risk for consumers and the environment. The Ministry plans for the first reports to be due in early 2014.

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On September 11, 2012, the Organization for Economic Cooperation and Development (OECD) posted a brochure entitled “Six Years of OECD Work on the Safety of Manufactured Nanomaterials: Achievements and Future Opportunities.” The brochure notes that “[a]fter six years of work, the OECD and its member countries have come to the conclusion that the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials.” According to the brochure, knowing that the testing and assessment approaches for traditional chemicals are generally appropriate for assessing nanomaterials, OECD intends to focus on the specific aspects of manufactured nanomaterials that require the adaptation and/or development of specific testing methods used for assessing human health and environmental safety and on developing guidance documents for assessing manufactured nanomaterials adapted to their specificities. OECD states that this will include guidance on estimating exposure on how to use results on physicochemicals endpoints in exposure assessment and mitigation measures to reduce exposure to safe levels. The brochure highlights OECD’s activities concerning manufactured nanomaterials since 2006, including its Sponsorship Programme for the Testing of Manufactured Nanomaterials and development of guidance on exposure measurement and on exposure mitigation.

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On September 5, 2012, the National Research Council (NRC) released a pre-publication version of a report entitled Science for Environmental Protection:  The Road Ahead. The U.S. Environmental Protection Agency (EPA) asked NRC to assess EPA’s overall capabilities “to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities.” The report discusses nanotechnology as an example of using emerging science to address regulatory issues and support decision-making. The Committee states that, to have the capacity to address emerging tools, technologies, and challenges, EPA “will need to have enough internal expertise to identify and collaborate with the expertise of all of its stakeholders in order to ask the right questions; determine what existing tools and strategies can be applied to answer those questions; determine the needs for new tools and strategies; develop, apply, and refine the new tools and strategies; and use the science to make recommendations based on hazards, exposures, and monitoring.” According to the report, the example of engineered nanomaterials “illustrates some of the problems and pitfalls of current approaches to emerging technologies.” While EPA provided early funding regarding the use of nanotechnology in remediation, the report states that it missed the opportunity to support research addressing the environmental health and safety of nanomaterials, pollution prevention in the production of nanomaterials, and the use of nanotechnology to prevent pollution. The reasons for the delay in early intervention include “insufficient federal agency leadership, emphasis, and policy regarding proactive rather than reactive approaches to safer design.” If EPA intends to promote and guide early intervention in the design and production of emerging chemicals, materials, and products, the report states, “it will need to commit to this effort beyond its regulatory role.”

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On August 31, 2012, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) issued a call for experts on the safety assessment of nanomaterials in cosmetic products. Under Article 16 of the Cosmetic Regulation EC No 1223/2009, any cosmetic product containing nanomaterials must be notified to the EC six months prior to being placed on the market. In case of concern, the EC will request SCCS to provide an opinion. According to the EC website, to meet the expected demand for safety assessments, the Commission Health and Consumers Directorate General intends to identify relevant experts who will assist the work of the SCCS. The Working Group is looking for experts with knowledge in relation to nanomaterials, particularly those used in cosmetic products, in the following areas:

• Characterization;
• Chemistry;
• Systemic toxicity;
• Genotoxicity;
• Human exposure (including inhalation);
• In vitro and alternative methods; and
• Risk assessment for human health.

The deadline for submission for the call for experts is October 15, 2012.

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The International Organization for Standardization (ISO) Technical Committee (TC) 229 on nanotechnologies is preparing guidance on the format and content of voluntary labeling for manufactured nano-objects (MNO) and products, preparations, and mixtures containing MNOs. According to ISO, the guidance, ISO/TS 13830:2011, would also address the use of the term “nano” in product labeling. The European Committee for Standardization (CEN) was initially developing the guidance and, under CEN, the guidance would have included business-to-employee and business-to-business communications. During a June 2012 meeting, TC 229 decided to focus the guidance on consumer labeling, however. Other ISO guidance documents will address other kinds of business communications.

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Lynn L. Bergeson will chair a session of the first Sustainable Nanotechnology Organization (SNO) conference, which will be held November 4-6, 2012, in Arlington, Virginia. The conference will address the critical aspects of sustainable nanotechnology, including lifecycle assessment, green synthesis, green energy, food and agriculture, nanomedicine, industrial nanotechnology, environmental and biological fate, and the overall sustainability of engineered nanomaterials. Bergeson will chair a session on “Legal Aspects/Policy Considerations,” on November 5, 2012.

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The French Ministry of Ecology and Sustainable Development published an order in the August 10, 2012, Journal Officiel de la République Française concerning the content and submission requirements for the annual declarations of information relating to nanoparticle substances, as substances or as part of a mixture. The order comes into force on January 1, 2013, and provides details on how companies should meet the mandatory declaration obligations.

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On June 20, 2012, European Agency for Safety and Health at Work (EU-OSHA) posted a new literature review entitled Risk perception and risk communication with regard to nanomaterials in the workplace, which found “serious gaps in our awareness of the potential risks involved in handling nanomaterials at work, and serious shortcomings in the way that those risks are communicated to workplaces.” The review intends to:

• Summarize the general principles and theories of risk perception and communication, referring to relevant trends and current guidance on these topics;
• Identify the stakeholders involved in risk perception and communication for nanomaterials in the workplace, and appraise relevant research, studies, surveys, and risk communication initiatives that have been done to date at national and international levels; and
• Consider the gaps in knowledge and limitations of the risk communication initiatives in this area, and suggest ways these might be addressed, with a view to proposing how to communicate with workers and employers on the potential risks of nanotechnologies and highlighting the difficulties involved.

EU-OSHA states that risk communication strategies need to help employers make informed decisions about their workplaces and put adequate prevention measures in place, and to empower individual workers to take personal control of their own situations to protect themselves adequately.

 

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On August 8, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a request it received from the EC for a scientific opinion on the safety of medical devices containing nanomaterials. According to the request, Notified Bodies have identified the following cases of alleged use of nanomaterials:

• Carbon nanotubes in bone cements;
• Nanopaste hydroyapatite powder for bone void filling;
• Polymer setting material with nanoparticles in dental cements;
• Polycrystalline nanoceramics in dental restorative materials;
• Nanosilver or other nanomaterials used as coatings on implants and catheters; and
• Nanosilver used as an antibacterial agent.

The EC states that, in addition, there are reports of iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field, although this use has not yet been attributed clearly to the legislation on medicines or the to the legislation on medical devices. 

 

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The Pace Environmental Law Review (PELR) will publish a themed issue this winter concerning issues in the development and regulation of nanotechnology and biotechnology. Articles or essays should discuss the intersection between nanotechnology and/or biotechnology and environmental issues. PELR encourages submitters to take an interdisciplinary approach to nanotechnology and/or biotechnology from legal and other perspectives, including technology, science, public health, economics, or policy. Authors should send an abstract and cover letter to pelracq@law.pace.edu. The deadline for submissions of article proposals is September 30, 2012.

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On August 1, 2012, the U.S. Environmental Protection Agency (EPA) posted a final report entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA states “is intended to be used as part of a process to identify what is known and, more importantly, what is not yet known that could be of value in assessing the broad implications of certain nanomaterials.” According to EPA, “[t]he complex properties of various nanomaterials make evaluating them in the abstract or with generalizations difficult if not impossible.” EPA notes that the case study does not represent a completed, or even preliminary, assessment of nanosilver. Instead, it and other similar case studies are intended to support research planning efforts for nanomaterials. The case study is organized around the comprehensive environmental assessment (CEA) framework, which structures available information pertaining to the product lifecycle, transport, transformation and fate processes in environmental media, exposure-dose in receptors, and potential impacts in these receptors. If information is available, the case study also includes other direct and indirect ramifications of both primary and secondary substances or stressors associated with a nanomaterial. Through a structured collective judgment method, expert stakeholders used EPA’s draft case study to identify and prioritize research gaps that could inform future assessments and risk management efforts. Some of the research gaps pertain to nanosilver in disinfectant spray; others to nanosilver irrespective of its application, and still others to nanomaterials in general.

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On July 25, 2012, the Senate Committee on the Environment and Public Works approved Senator Frank Lautenberg’s (D-NJ) amended Safe Chemicals Act of 2011 (S. 847) in a 10-8 partisan vote. While the bill does not explicitly mention nano, potentially relevant provisions remain in the amended text. These include the bill granting the Administrator the ability to determine that a variant of a chemical substance that exhibits one or more special substance characteristics either “is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics” or is a distinct chemical substance. In the event that a chemical substance exhibiting special substance characteristics is considered to be a variant that is a separate use, the manufacturer or processor will be required to satisfy conditions that are established by the Administrator. In the event that a chemical substance exhibiting special substance characteristics is considered to be a distinct chemical substance, and is not listed on the active inventory of chemicals manufactured or processed in the U.S., the manufacturer or processor would be required to submit data. This measure could have a significant impact on nanoscale chemical substances.

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On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act” or other statutes administered by FDA. The Secretary may:

1. Assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to FDA;
2. In cooperation with other federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;
3. Promote FDA programs and participate in collaborative efforts to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;
4. Promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;
5. Collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;
6. Build scientific expertise on nanomaterials within FDA, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under the Act;
7. Ensure ongoing training, as well as dissemination of new information within the FDA centers, and more broadly across FDA, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;
8. Encourage FDA to participate in international and national consensus standards activities pertaining to nanomaterials; and
9. Carry out other activities that the Secretary determines are necessary and consistent with the purposes described above.

 

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According to a July 10, 2012, memorandum added to the registration review docket for nanosilver, the Federal Register notice announcing the opening of the docket erroneously listed the comment period end date as August 19, 2012. The U.S. Environmental Protection Agency (EPA) memorandum states that the comment period has been extended to September 10, 2012, “to allow for a full 60-day comment period [that] is standard for registration review docket openings.”

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The British Standards Institution (BSI) announced on July 9, 2012, the availability of three new standards and the development of a fourth standard intended to help mitigate the risks involved in manufacture and disposal of nanotechnology products. The three new Publicly Available Specifications (PAS) are:

• PAS 134:2012 -- Terminology for carbon nanostructures, 2nd edition: Revised to help ensure the use of a consistent language across the disparate industries and technologists involved in this area;
• PAS 138:2012 -- Guide to the disposal of manufacturing process waste containing manufactured nano-objects: Provides guidance regarding the disposal of manufactured nanomaterials and objects and will support manufacturers and others in making decisions as to the most appropriate way to dispose of their process waste; and
•  PAS 139:2012 -- Detection and characterization of manufactured nano-objects in complex matrices: Provides guidance concerning the detection and characterization of nano-objects and to those who want to understand their impacts on human and environmental health.

Additionally, BSI is developing a fourth PAS:

• PAS 137:2012 -- Nanomaterials and nanotechnology-based products -- Guide to regulations and standards: Provides guidance for United Kingdom (UK) organizations (including small- and medium-sized enterprises (SME)) by signposting regulation and standards relevant to the importation, manufacture, processing, distribution, and sale of nanomaterials and nanotechnology-based products, thereby assisting organizations in their business development and commercial success.

 

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The July 3, 2012, edition of the National Institute for Occupational Safety and Health (NIOSH) eNews includes a nanotechnology update, which states that the critical question to address is whether nanomaterials pose health or safety risks to workers employed in their manufacture and industrial use. The update includes the following “notable recent findings and areas of research”:

• A peer-reviewed paper recently published by NIOSH researchers addressing five areas to help focus action to protect workers:
  • Review of the current evidence on the carcinogenic potential of carbon nanotubes (CNT), based on laboratory studies;
  • The role of physical and chemical properties related to cancer development;
  • CNT doses associated with changes to or damages in genes in laboratory animals and human tissue specimens;
  • Workplace exposures to CNT; and
  • Specific risk management actions needed to protect workers.
• A study linking nanoparticle exposure to cellular responses associated with autoimmune risks. In laboratory studies, exposures to certain types of nanoparticles produced cellular changes that are associated with risks for disorders of the autoimmune system such as rheumatoid arthritis.
• A recent paper highlighting the findings from an evaluation of the quality and completeness of information of nanomaterial safety data as it pertains to hazard identification, exposure controls, personal protective equipment, and toxicological information being communicated about the engineered nanomaterial. The study determined that the majority of the safety data sheets obtained in 2010-2011 provided insufficient data for communicating the potential hazards of engineered nanomaterials.
• In a paper published in June, NIOSH researchers scrutinize the “oxidative stress paradigm,” a widely accepted scientific model for understanding the processes that in general are associated with cellular damage, to better understand the processes that can occur from reactions to nanoparticles. The answer to this question will have important ramifications for the development of strategies for mitigation of potential adverse effects of nanoparticles.
• Recent findings indicating that improperly designed, maintained, or installed engineering controls may not be completely effective in controlling releases of nanomaterials into the workplace. Unprotected skin exposure to carbon nanofibers was noted in two instances and indicated the need for educating workers on the use of personal protective equipment.
• A summary of emission data collected at four facilities that volunteered to serve as test sites. The measurements indicated that specific tasks can release engineered nanomaterials into the workplace atmosphere and that traditional controls such as ventilation can be used to limit exposure. Much research is still needed to understand the impact of nanotechnology on health, and to determine appropriate exposure monitoring and control strategies.

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The Netherlands National Institute for Public Health and the Environment (RIVM) published on June 29, 2012, a report entitled Interpretation and implications of the European Commission Recommendation on the definition of nanomaterial. The Dutch ministries requested RIVM to interpret the meaning and implications of the European Commission’s (EC) recommendation from a scientific perspective and to consider the implications for use in legislation. RIVM intends the report to provide the basis for discussions by policy makers and stakeholders on the use and further implementation of the recommended definition in national and international legal frameworks. RIVM concludes that, while the EC’s recommendation contains the relevant aspects, further guidance is necessary to ensure the definition is interpreted consistently. According to RIVM, the next step is to incorporate the definition into legal frameworks regarding the interpretation of the term nanomaterial. RIVM states that this will lead to the collection of “nano-specific” data, contributing to further insight into the “nano-specific” properties and the fate, kinetics, and effects of nanomaterials. This will help focus on the specific needs for risk assessment and risk management of nanomaterials.

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On July 6, 2012, the U.S. Environmental Protection Agency (EPA) announced the establishment of a registration review docket for nanosilver. EPA states that registration review is its “periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment.” Registration review dockets include information intended to assist the public in understanding the types of information and issues that EPA may consider during the course of registration reviews. According to the preliminary work plan, EPA has information that there are silver-based pesticide products that were registered without the registrant disclosing to EPA the presence or characteristics of the nanosilver in their products. EPA sent a letter in August 2009 to each registrant with silver-based products requesting a statement as to whether their products contained any amount of silver in any form having a dimension that measures between 1 and approximately 100 nanometers. Four registrants responded that their products, which were registered using data for conventional silver, contain nanosilver. In the preliminary work plan, EPA states it is identifying several other products, registered using data for silver chloride, as potentially containing nanosilver. The registration review for nanosilver includes these products, as well as the two HeiQ nanosilver products conditionally registered in December 2011. According to the preliminary work plan, EPA believes that additional data are needed to determine whether the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for maintaining these registrations is met “due to nanosilver’s unique physical and chemical properties, and thus nanosilver’s potentially different health and safety properties as compared to silver.”

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On July 4, 2012, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted its Guidance on the safety assessment of nanomaterials in cosmetics. The EC requested the SCCS develop guidance on the elements that would be required in a manufactured nanomaterial safety dossier. The SCCS states that the Guidance is intended to provide information to help compliance with the requirements for the safety assessment of nanomaterials intended for use in cosmetic products.  The Guidance describes the need for special considerations in relation to the safety of nanomaterials, in view of the possible distinct properties, interactions, and/or effects that may differ from the conventional form of the same materials.  The Guidance includes the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic ingredients, i.e., general safety considerations, material characterization, exposure assessment, hazard identification and dose-response characterization, and risk assessment. The Guidance notes that the Cosmetics Regulation No 1223/2009 defines nanomaterial as “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm,” and that this definition could be revised in light of the EC’s October 2011 Recommendation on the  definition of a nanomaterial. According to the Guidance, if the Cosmetics Regulation definition were aligned to the Recommendation, it would provide further information on whether a material falls under the definition of a nanomaterial.

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The United Nations (UN) Food and Agriculture Organization (FAO) and World Health Organization (WHO) have released a draft paper entitled State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors for comment. FAO and WHO commissioned the paper with the objective of summarizing and analyzing the information that has become available since their 2009 expert meeting and determining possible courses of action. The draft paper reviews national and international activities on the risk analysis of nanomaterials in the food and agriculture sectors that have been carried out since the meeting. It presents national and international risk assessment and risk management approaches that identify and implement strategies to address potential hazards associated with the use of nanotechnology-related products or techniques. Information on relevant regulations and risk assessment activities was gathered from the websites of 16 national and international institutions, organizations, and governments. Information on actual and planned uses of nanomaterials resulting in human exposure through food or food packaging/contact materials since 2009 was collected from a variety of sources, including the scientific literature, websites, patent databases, market analysis reports, and material presented at conferences, workshops, and symposia. Comments are due November 30, 2012.

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The U.S. Environmental Protection Agency (EPA) announced on July 2, 2012, the availability of an external review draft document entitled Nanomaterial Case Study: A Comparison of Multiwalled Carbon Nanotube and Decabromodiphenyl Ether Flame-Retardant Coatings Applied to Upholstery Textiles (EPA/600/R-12/043A). EPA states that the draft document “does not draw conclusions regarding potential environmental risks or hazards of multiwalled carbon nanotubes (MWCNT); rather, it aims to identify what is known and unknown about MWCNT to support future assessment efforts.” On October 29, 2012, EPA will hold a public information exchange meeting to: (1) receive comments and questions on the draft document; and (2) provide information on the draft EPA nanomaterial case study and the workshop process that the draft document will be used in for identifying and prioritizing research gaps that could support future assessment and risk management efforts for MWCNT. Following the conclusion of the October 29 meeting, RTI International, an EPA contractor, will conduct a separate meeting on the “Nanomaterial Case Study Workshop Process: Identifying and Prioritizing Research for Multiwalled Carbon Nanotubes”' in the same location. EPA states that the workshop will be conducted independently by RTI International, with a set of invitee-only expert participants selected by RTI International, and will use a “structured decision science process” similar to the process used in previous workshops on nanoscale titanium dioxide in water treatment and in topical sunscreen and nanoscale silver in disinfectant spray. The RTI workshop will be open to public observers. Written comments on the draft document are due August 31, 2012. Registration for the public information exchange meeting will close on October 15, 2012. Space is limited, and reservations will be accepted on a first-come, first-served basis.

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The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach.  The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop. Registration is open until July 13, 2012.

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On April 16, 2012, the Natural Resources Defense Council (NRDC) filed its brief in its lawsuit against the U.S. Environmental Protection Agency (EPA) concerning EPA’s conditional registration for HeiQ AGS-20, an end-use product containing nanosilver. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California) against EPA, seeking to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles and prevent EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.”

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The Health Council of the Netherlands announced on May 22, 2012, the availability of a draft report proposing the implementation of an exposure registry and a system of health monitoring when working with engineered nanoparticles. The draft report states that, due to the concerns and lack of knowledge, the Health Council “considers it prudent” to create an exposure registry. The Health Council recommends that the exposure registry be created for “insoluble and poorly in water soluble nanoparticles in any composition or physical structure, including nanoparticles that are present in solid materials.” The draft report acknowledges that, if solid materials are in good condition, “scarcely any nanoparticles will be released, but due to wear and tear and handling, such as drilling and sanding, it cannot be excluded that such particles can be released with all the associated risks.” The draft report concludes that, “[f]rom the point of view of health, it is best to also register the solid materials.” Data submitted to the registry would need to include chemical and physical properties, determinants of emission and exposure, and exposure concentrations. Regarding medical surveillance, the draft report concludes that implementation of a passive system is the best option. While a passive system would not provide answers quickly on whether health risks exist when working with nanoparticles, and if so, which type of health effects, when combined with other activities, such as targeted scientific research, it “may give a valuable contribution in the future to providing insight in the potential health risks due to exposure to nanoparticles.” Comments on the draft report, which was presented to experts of employer’s organizations and trade unions, are due August 10, 2012. According to the Health Council, it will consider comments when preparing the final report, which will be presented to the State Secretary of Social Affairs and Employment.

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The European Chemicals Agency (ECHA) recently held a two-day workshop concerning its first experiences with nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, with an emphasis on the evaluation process. ECHA, Member State Competent Authorities (MSCA), accredited stakeholders, and the European Commission (EC) discussed how nanomaterials in general have been characterized in registration dossiers. Currently, according to ECHA, the scope of the registration (i.e., whether and how many nano-forms are included) is often unclear and the level of nano-specific information provided (e.g., substance characterization, hazards, exposure, and risks) shows “significant room for improvement.” ECHA agreed with MSCA representatives on a common approach to addressing the current information requirements in nanomaterial dossiers, taking into account the scientific uncertainties and legislative framework provided by REACH. ECHA states that it will implement the EC’s recommendation on the definition of a nanomaterial as a benchmark in assessing substances, and “invites registrants to proactively characterise their substances in light of this definition.” Workshop participants discussed creating a working group on nanomaterials that would provide advice on scientific and technical principles related to nanomaterials under REACH. The working group on nanomaterials would act independently, but report to the relevant ECHA committees. According to ECHA, the mandate of this working group will be further consolidated with the MSCAs. In addition, ECHA intends to disseminate the best practices that it has collected from relevant stakeholders that registered nanomaterials and that were discussed in the first “Group Assessing Already Registered Nanomaterials” meeting prior to the workshop. ECHA intends to post the best practices on its website by this summer.

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On May 25, 2012, the European Chemicals Agency (ECHA) published three new appendices, updating Chapters R.8, R.10, and R.14 of the Guidance on Information Requirements and Chemical Safety Assessment.  ECHA updated the guidance based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 3, which concerned aspects such as occupational exposure estimation and dose-response characterization for human health and for environment. According to ECHA, the updated appendices “will further enhance the advice to registrants of substances in the nanoform a full year in advance of the next REACH registration deadline,” May 31, 2013.

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The International Organization for Standardization (ISO) has published a Technical Report (TR) providing guidance on the physicochemical characterization of manufactured nano-objects prior to toxicological assessment.  ISO states that TR 13014:2012, Nanotechnologies -- Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, “is intended to assist health scientists and experts to understand, plan, identify, and address relevant physicochemical characteristics of nano-objects before conducting toxicological tests on them.” ISO Technical Committee (TC) 229 Working Group (WG) 3, Health, Safety, and Environmental Aspects of Nanotechnologies, prepared the TR. The U.S. Technical Advisory Group (TAG) to ISO TC 229, which is accredited and administered by the American National Standards Institute (ANSI), is open to all materially affected U.S. national interested parties. The U.S. TAG formulates positions and proposals on behalf of the U.S. with response to ISO standardization activities, and provides the delegates and experts who represent the U.S. at meetings of the respective ISO TCs, subcommittees, and WGs.

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On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. The presentation slides and plenary videos are now available online.

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The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed the use of occupational exposure levels (OEL) by the federal government. Because the Occupational Safety and Health Administration’s (OSHA) permissible exposure limits (PEL) have remained unchanged since their adoption on May 29, 1971, and do not account for advances in technology or the latest data, FACOSH asked its Emerging Issues Subcommittee to analyze federal agencies’ use of PELs. As part of its review, the Subcommittee identified other issues of interest, including dispersible engineered nanomaterials (DENM). A document entitled “Recommendations for Consideration by the U.S. Secretary of Labor on the Adoption and Use of Occupational Exposure Limits by Federal Agencies” includes the following text concerning DENMs:

• OSHA defines nanomaterials as, “materials that have been purposefully manufactured, synthesized, or manipulated to have a size with at least one dimension in the range of approximately 1 to 100 nanometers and that exhibit unique properties determined by their size.”
• Published scientific studies have indicated that at least some DENMs are biologically active, have produced toxicological reactions in the lungs of exposed experimental animals, and may readily penetrate intact human skin. While DENMs are truly an emerging issue and published results are not plentiful, scientists and federal agencies, such as NIOSH, continue to conduct research to understand fully the potential health effects of exposure.
• Currently, both scientists and federal agencies agree that DENM toxicity depends heavily on the physical and chemical properties of the nanoparticles, such as particle size and size distribution, agglomeration state, shape, crystal structure, chemical composition, surface area, surface chemistry, surface charge, and porosity, and that these properties may differ substantially from those of the same material in macro-scale form.

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On May 10, 2012, the Council of the European Union (EU) announced the adoption of a regulation concerning the placing on the market and use of biocidal products, which include insecticides, disinfectants, and repellents, but not medicines or agricultural pesticides. The regulation will take effect September 1, 2013, with a transitional period for certain provisions. The regulation incorporates the European Commission’s (EC) recommendation on the definition of a nanomaterial, and requires that, where nanomaterials are used in a product, the risk to the environment and to health be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word “nano” in brackets. The regulation states that “approval of an active substance shall not cover nanomaterials except where explicitly mentioned.”

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The U.S. delegation to the July 4-6, 2012, meeting of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is considering presenting an information paper on how to classify nanomaterials under the GHS. According to Kathy Landkrohn, Occupational Safety and Health Administration (OSHA) Directorate of Standards and Guidance, the paper would be presented under a work group examining the types of physical and chemical properties listed on safety data sheets (SDS). Landkrohn stated that a lack of data has impeded the work group’s ability to create a separate hazard class for nanomaterials.

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On May 14, 2012, the U.S. Environmental Protection Agency (EPA) and the Department of Commerce announced efforts to launch an environmental technology initiative intended to help create American jobs in the growing environmental industry. EPA released a document entitled Technology Innovation for Environmental and Economic Progress: An EPA Roadmap, which states that EPA “will undertake policy, regulatory, financial, and voluntary actions, grounded in science, that will promote innovation along the entire continuum of technology development and deployment.” Specifically, according to the Roadmap, EPA “will advocate more cost-effective, innovative solutions that eliminate, or significantly reduce, adverse impacts to natural resources in a manner that promotes healthy, productive communities.” EPA states that its initial efforts will focus on four broad actions:

1. Designing EPA policies, regulations, standards, permits, and procedures to leverage technology innovation;
2. Catalyzing technology design, development, finance, commercialization, and adoption through partnerships with stakeholders;
3. Stimulating cross-Agency consideration, development, commercialization, and adoption of breakthrough technologies; and
4. Developing a new relationship with the investment community. EPA will take a number of steps to build relationships and improve communication.

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On May 14, 2012, the agencies participating in the National Nanotechnology Initiative (NNI) announced the fourth Nanotechnology Signature Initiative, “Nanotechnology Knowledge Infrastructure:  Enabling National Leadership in Sustainable Design” (NKI). According to a press release issued by the National Nanotechnology Coordination Office (NNCO), this signature initiative will stimulate the development of models, simulation tools, and databases to enable the prediction of specific properties and characteristics of nanoscale materials.  This will then accelerate commercialization of nanotechnology innovations that maximize benefits to humans and the environment while minimizing risks. NKI identifies four areas that will benefit from focused attention:

1. A diverse collaborative community of scientists, engineers, and technical staff to support research, development, and applications of nanotechnology to meet national challenges;
2. An agile modeling network for multidisciplinary intellectual collaboration that effectively couples experimental basic research, modeling, and applications development;
3. A sustainable cyber-toolbox to enable effective application of models and knowledge to nanomaterials design; and
4. A robust digital nanotechnology data and information infrastructure to support effective data sharing, collaboration, and innovation across disciplines and applications.

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The Strategic Approach to International Chemicals Management (SAICM) Secretariat is expected to publish this month comments on Switzerland’s proposal that activities relating to nanotechnology be added to the SAICM Global Plan of Action.  The proposal would include a new work area on nanotechnologies and manufactured nanomaterials, with corresponding activities, actors, and targets. The Secretariat will compile the comments to inform discussion at the third International Conference on Chemicals Management (ICCM3), which will be held September 17-21, 2012. The Nanotechnology Industries Association (NIA) submitted detailed comments on the proposal.

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The Congressional Research Service (CRS) published an April 13, 2012, document entitled Nanotechnology: A Policy Primer that provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. CRS states that, since the launch of the National Nanotechnology Initiative (NNI) in 2000 through fiscal year (FY) 2012, Congress has appropriated approximately $15.6 billion for nanotechnology R&D, including approximately $1.7 billion in FY 2012. President Obama has requested $1.8 billion in NNI funding for FY 2013. More than 60 nations have established similar programs, and, according to CRS, in 2010, the total global public R&D investments were approximately $8.2 billion, complemented by an estimated private sector investment of $9.6 billion.  Based on the data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents), the U.S. appears to be the overall global leader in nanotechnology, though CRS cautions that some believe the U.S. lead “may not be as large as it was for previous emerging technologies.” According to CRS, some research has raised concerns about the safety of nanoscale materials, and “[t]here is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation.”

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On May 1, 2012, President Barack Obama signed an Executive Order (EO) entitled “Promoting International Regulatory Cooperation,” which is intended to ensure that differing regulatory approaches taken by foreign governments do not unnecessarily limit the ability of American businesses to export and compete internationally. EO 13563, which Obama signed on January 18, 2011, states that the U.S. regulatory system must protect public health, welfare, safety, and the environment while promoting economic growth, innovation, competitiveness, and job creation. The May 1, 2012, EO calls for the Regulatory Working Group established by Executive Order 12866, and reaffirmed by EO 13563, to serve as a forum to discuss, coordinate, and develop a common understanding among agencies of U.S. government positions and priorities with respect to: international regulatory cooperation activities that are reasonably anticipated to lead to significant regulatory actions; efforts across the federal government to support significant, cross-cutting international regulatory cooperation activities; and promotion of good regulatory practices internationally, as well as the promotion of U.S. regulatory approaches, as appropriate.

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Representatives Bill Pascrell, Jr. (D-NJ) and Brian Bilbray (R-CA) introduced on April 26, 2012, the Qualifying Renewable Chemical Production Tax Credit Act of 2012 (H.R. 4953), which would amend the Internal Revenue Code to provide a credit for the production of renewable chemicals. The credit would be equal to $0.15 per pound of eligible content of renewable chemical produced during the taxable year. Eligible content would mean the biobased content percentage of the total mass of organic carbon in such chemical. Renewable chemical would mean any chemical produced in the U.S. from renewable biomass that is sold or used for the production of polymers, plastics, or formulated products, or as polymers, plastics, or formulated products, and is not sold or used for the production of any food, feed, or fuel. Chemicals would be excluded if the biobased content percentage is less than 25 percent; 10,000,000 pounds or more of such chemical was produced in 2000 from renewable biomass; the chemical is neither the product of nor reliant upon, biological conversion, thermal conversion, or a combination of biological and thermal conversion, of renewable biomass; or the chemical is composed of renewable chemicals that are eligible for a credit under the bill. The total number of credits under the program would be limited to $500,000,000, and no taxpayer may receive more than $25,000,000 in any taxable year. The program would end five years after the date of enactment of the bill. The bill was referred to the House Committee on Ways and Means.

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On April 30, 2012, the European Chemicals Agency (ECHA) announced the availability of three appendices, updating Chapters R.7a, R.7b, and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA). ECHA prepared a draft revision of the Guidance, based on the outcome of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Projects on Nanomaterials (RIP-oN) 2 final report. ECHA updated the Guidance via a fast-track procedure, and states that this was justified on the basis that the final RIP-oN 2 report had already been the subject of consultation with relevant stakeholders. Its content could, therefore, be considered as reflecting a consensus. Furthermore, according to ECHA, the update “needed to be made urgently in order to allow publication of the guidance as soon as possible and well in advance of the next REACH registration deadline,” May 30, 2013. The updated Guidance provides tailored advice to prepare registrations for substances in the nanoform.

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On April 27, 2012, the President’s Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, “has had a ‘catalytic and substantial impact’ on the growth of the U.S. nanotechnology industry and should be continued.” PCAST states that, in large part due to the NNI, the U.S. “is today, by a wide range of measures, the global leader in this exciting and economically promising field of research and technological development.” The Obama Administration has proposed $1.8 billion in funding for fiscal year 2013 for 15 agencies with budgets dedicated to nanotechnology research and development (R&D).

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On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced commitments supportive of the Blueprint’s goals. These include initiatives to encourage federal procurement of an expanded range of biobased products; take better advantage of large pharmaceutical data sets to speed drug development; apply the latest genomics discoveries to identify quickly emerging microbial threats; and accelerate research on non-embryonic stem cells as possible treatments for blood-related and neurological diseases.

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On April 18, 2012, the United States Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) promulgated a final rule amending the Federal Acquisition Regulation (FAR) to implement changes due to the Farm Security and Rural Investment Act that require contractors to report the biobased products purchased under service and construction contracts.  According to the Federal Register notice, the reporting will enable agencies to monitor compliance with the federal preference for purchasing biobased products. The information reported by prime contractors will enable federal agencies to report annually information concerning actions taken to implement the preference for biobased products, and assess compliance and measure progress in carrying out the preference for biobased products.  Where information on the biobased nature of products is not already available, the notice states that contractors may need to create an inventory management system to track the product types and dollar value of United States Department of Agriculture (USDA)-designated biobased products purchased for each contract.  DoD, GSA, and NASA expect that the impact will be minimal, however, because the existing clause already requires contractors to make maximum use of biobased products. The final rule will be effective May 18, 2012.

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On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.” FDA states that the food draft guidance describes factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• Affect the identity of the food substance;
• Affect the safety of the use of the food substance;
• Affect the regulatory status of the use of the food substance; or
• Warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

• The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled; and
• To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

FDA notes that both guidance documents encourage manufacturers to consult with it before taking their products to market. According to FDA, this consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status. Comments will be due 90 days after FDA announces their availability in the Federal Register.

 

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The European Chemicals Agency (ECHA) sent three new draft appendices to Chapters R.8, R.10, and R.14 of the guidance on information requirements and chemical safety assessment concerning recommendations for nanomaterials to the Competent Authorities for Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) (CARACAL). The draft appendices are based on the results of the REACH Implementation Project on Nanomaterials (RIPoN).  The draft appendices are available at:

• R.8 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r8_clean_en.pdf;
• R.10 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r10_clean_en.pdf; and
• R.14 -- http://echa.europa.eu/documents/10162/13643/appendix_to_r14_clean_en.pdf.

 

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The European Agency for Safety and Health at Work (EU OSHA) posted an item on April 16, 2012, concerning a French report on the feasibility of an epidemiological surveillance system for workers exposed to engineered nanomaterials. EU OSHA notes that the French Health and Occupational Ministries asked the French Institute for Public Health Surveillance (InVS), supported by a multidisciplinary working group convened by the Institute for Public Health Research, to assess the feasibility of an epidemiological surveillance system of workers likely to be exposed to engineered nanomaterials.  The resulting report “draws up an inventory of the numerous uncertainties inherent to this field such as the question of definition, the wide range of nanomaterials, the identification of health events that could be monitored, the registration and collaboration of companies and workers likely to be concerned by nanomaterials and the metrological issues.” According to EU OSHA, InVS suggests the implementation of a double surveillance system with a prospective cohort study and repeated cross-sectional studies.  The repeated cross-sectional studies would include all kinds of nanomaterials, while the cohort study would focus on a few.  In conclusion, EU OHSA states, the report gives some recommendations for epidemiological research. While the French report is dated 2011, an English summary is dated 2012.

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The Organization for Economic Cooperation and Development (OECD) recently published a new document in its series on the safety of manufactured nanomaterials, Important Issues on Risk Assessment of Manufactured Nanomaterials. The document was prepared by Steering Group Six of the Working Party on Manufactured Nanomaterials (WPMN), which is leading the project on cooperation on risk assessment, and was endorsed at the ninth meeting of the WPMN in December 2011. The document provides the current practices, challenges, and strategies for assessing risk in circumstances where data are limited, and there is a necessity for more research on specific risk assessment issues. OECD cautions that it is not to be construed to imply scientific and/or policy endorsement of any specific risk assessment methods or models, however.  OECD notes that “this document is a living document,” and was current at the time of WPMN’s ninth meeting in December 2011. The document is subject to amendment and refinement as research affords further understanding of how to assess and manage nanomaterials.

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In an April 4, 2012, final rule, the U.S. Department of Agriculture (USDA) amended the Guidelines for Designating Biobased Products for Federal Procurement to add 13 sections to designate product categories within which biobased products will be afforded federal procurement preference. USDA also established minimum biobased contents for each of these product categories. The 13 categories are: air fresheners and deodorizers; asphalt and tar removers; asphalt restorers; blast media; candles and wax melts; electronic components cleaners; floor coverings (non-carpet); foot care products; furniture cleaners and protectors; inks; packing and insulating materials; pneumatic equipment lubricants; and wood and concrete stains. USDA has determined that each of these product categories meets the necessary statutory requirements; that they are being produced with biobased products; and that their procurement will carry out the following objectives of Section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation, and Energy Act of 2008: to improve demand for biobased products; to spur development of the industrial base through value-added agricultural processing and manufacturing in rural communities; and to enhance the nation’s energy security by substituting biobased products for products derived from imported oil and natural gas. With the designation of these specific product categories, USDA invites the manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. The final rule will be effective May 4, 2012.

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On April 10, 2012, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) invited interested parties to submit any relevant information that could assist it with its assessment of the safety, health, and environmental effects of nanosilver. In particular, SCENIHR states, it is interested in receiving any scientific information related to the “nano” forms of silver. The EC requested on December 9, 2011, that SCENIHR prepare a scientific opinion on the safety, health, and environmental effects and role in antimicrobial resistance of nanosilver. The EC requested 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. All information submitted to SCENIHR is considered public unless otherwise stated by the provider. Information is due to SCENIHR by June 4, 2012.

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Bergeson & Campbell, P.C. (B&C) and The Acta Group, L.L.C. (Acta) will hold a complimentary webinar on April 18, 2012, from 1:30 to 3:30 p.m. (EDT) on the Occupational Safety and Health Administration's (OSHA) final rule revising the OSHA Hazard Communication Standard (HCS) issued on March 26, 2012. The final rule aligns the HCS with the United Nations' Globally Harmonized System for Chemical Classification and Labeling (GHS). OSHA estimates the rule is expected to impact some five million U.S. workplaces and have an annual cost of approximately $97 million.

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On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. EPA states that, based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, however, no significant inhalation exposures are expected, and EPA “has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk.” EPA notes that it has determined, however, that a manufacturing process other than as described in the PMN may cause serious health effects. Based on this information, EPA states the PMN substance meets the concern criteria at 40 C.F.R. Section 721.170(b)(3)(ii). EPA determined that the results of the following information would help characterize the health effects of the PMN substance: the dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. Under the SNUR, these properties should be determined once a year for three consecutive years. The direct final rule is effective on June 4, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, are due May 4, 2012.

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On March 27-28, 2012, the Organization for Economic Cooperation and Development (OECD), in collaboration with the National Nanotechnology Initiative (NNI), and hosted by the American Association for the Advancement of Science (AAAS) held an International Symposium on Assessing the Economic Impact of Nanotechnology. The objective of the symposium was to explore systematically the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts. Lynn L. Bergeson was on the Steering Committee and presented at the symposium. NNI has posted the following background papers:

• Challenges for Governments in Evaluating Return on Investment from Nanotechnology and its Broader Economic Impact;
• Finance and Investor Models in Nanotechnology;
• The Economic Contributions of Nanotechnology to Green and Sustainable Growth; and
• Models, Tools and Metrics Available to Assess the Economic Impact of Nanotechnology.

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The B&C Consortia Management, L.L.C. (BCMM) is pleased to announce that the UCLA Center for Environmental Implications of Nanotechnology will be hosting a workshop that will be sponsored by The California Nanotechnology Industry Network (CalNIN) on Challenges and Opportunities for Businesses Engaged in Nanotechnology on September 25, 2012.

Planned topics include:

• Nanotechnology industry in California;
   
• Regulatory initiatives;
   
• Concerns with nanomaterials in the environment;
   
• Programs, resources, and research opportunities;
   
• Federal programs; and
   
• Educational needs and opportunities.

For more information, log onto www.calnin.org or contact Jake Vandevort.

Registration opens on May 15, 2012.

Stay tuned for additional details on the workshop!

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On May 9-11, 2012, the Organization for Economic Cooperation and Development (OECD) and Germany’s Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) will hold a workshop entitled “Safe Management of Nanowaste.” According to the draft agenda, the objectives of the workshop are to get a better understanding of the potential risks posed by nanowaste and waste containing nanomaterials; to exchange information about existing initiatives/approaches addressing nanowaste management; and to identify what OECD and member country governments can do to ensure safe management of such materials. After the workshop, the OECD Secretariat will prepare a report on the discussions and conclusions of the workshop, for submission to the next meeting of the Working Party on Resource Productivity and Waste in November 2012.  The report will include proposals for further work and potential role of OECD in this area. Because space is limited, OECD’s Business and Industry Advisory Committee (BIAC) has been invited to nominate up to three participants. Interested persons should contact BIAC by April 11, 2012. Participation will be subject to confirmation, and interested persons should wait for formal confirmation before making travel arrangements.

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On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:

• Carbon nanotubes in bone cements;
• Nanopaste hydroyapatite powder for bone void filling;
• Polymer setting material with nanoparticles in dental cements;
• Polycrystalline nanoceramics in dental restorative materials;
• Nanosilver or other nanomaterials used as coatings on implants and catheters; and
• Nanosilver used as an antibacterial agent, for example in wound dressings.

Furthermore, according to the request, there are reports on iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field. The EC states that, when assessing nanomaterials for medical applications, the risk assessor should be aware of the specific characteristics of nanomaterials to obtain appropriate information to be able to do the risk assessment of the application of nanomaterials in a medical technology. According to the request, the EC is currently preparing a proposal for a revision of the medical devices directives. The proposal might include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR’s opinion is March 2013.

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On March 5, 2012, Safe Work Australia announced the release of an information sheet on the safe handling and use of carbon nanotubes in the workplace and a document entitled Safe Handling and Use of Carbon Nanotubes. The information sheet provides an overview of risk management for carbon nanotubes, while Safe Handling and Use of Carbon Nanotubes describes two approaches to managing the risks: risk management with detailed hazard analysis and exposure assessment, and risk management by using control banding. Either or both of these methods may be used, depending on the circumstances. Safe Work Australia states that the guidance is applicable to other forms of carbon nanofibers, such as carbon nanorods and carbon nanowires.  It is also applicable to products containing carbon nanotubes and other forms of carbon nanofibers where these nanomaterials may be released during handling. Safe Work Australia has commissioned a human health hazard assessment and classification of carbon nanotubes, and it expects to publish the findings in mid-2012.

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S.B. 533, which was prepared for the Joint Legislative Council’s Special Committee on Nanotechnology, was introduced in the Wisconsin Senate on February 29, 2012, by the Joint Legislative Council.  The bill directs the University of Wisconsin System Board of Regents to maintain a nanotechnology information hub, for at least five years, to promote the development of nanotechnology businesses in Wisconsin, and gather and disseminate information about environmental health and workplace safety related to nanotechnology. The hub is directed to report to the legislature on emerging nanotechnology health and safety information, and at the direction of the nanotechnology council, identify needed legislation relating to nanotechnology safety and development. The nanotechnology council, which would be created by the bill, would set policies and priorities for the nanotechnology information hub and make grants for research and development related to nanotechnology, subject to the availability of funding. The bill does not appropriate any funds for grants but rather directs the nanotechnology hub to seek and compete for federal, state, or other funding to support its activities and to be used by the nanotechnology council to make grants.

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On February 29, 2012, the European Chemicals Agency (ECHA) announced the first Community Rolling Action Plan (CoRAP), which includes 90 substances that Member States will evaluate under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) substance evaluation process. For each substance, ECHA notes the initial grounds for concern. For two substances, silicon dioxide and silver, the initial grounds for concern are “Substance characterization/Nanoparticles, toxicity of different forms of the substance.” Silicon dioxide is scheduled to be evaluated in 2012, by the Netherlands, and silver is scheduled to be evaluated in 2013, also by the Netherlands. ECHA notes that, when the substances are included in the CoRAP, “they have yet not been evaluated and thus the concern is indicative and not exhaustive or conclusive.”

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The National Institute for Occupational Safety and Health (NIOSH) Prevention through Design Program and Nanotechnology Research Center will hold an August 14-16, 2012, workshop entitled “Safe Nano Design: Molecule » Manufacturing » Market.” NIOSH states that participants will provide input into the safe commercialization of nano products resulting in the development of guidelines for the safe synthesis of nanoparticles and associated products, using a Prevention-through-Design approach.  The workshop will focus on efforts to develop safer nano molecules that have the same functionality; process containment and control, based on the considerations of risk of exposure to workers; and the management system approaches for including occupational safety and health into the nanoparticle synthetic process, product development, and product manufacture. Lynn L. Bergeson is on the Planning Committee for the workshop.

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The World Health Organization (WHO) released a draft background document proposing content and focus for Guidelines on “Protecting Workers from Potential Risks of Manufactured Nanomaterials.” According to WHO, the Guidelines will aim to facilitate improvements in occupational health and safety of workers potentially exposed to nanomaterials in a broad range of manufacturing and social environments.  The Guidelines will incorporate elements of risk assessment and risk management and contextual issues, and provide recommendations to improve occupational safety and protect the health of workers using nanomaterials in all countries, especially in low- and middle-income countries. The WHO Guideline Development Group will use the background document to identify key questions to be addressed by the Guidelines. WHO asks commenters to note that key questions to be addressed by the Guidelines “should be answerable, their number should be manageable and answers to the key questions should be useful to the target audience of these Guidelines.”  Comments are due March 31, 2012.

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President Obama signed a February 21, 2012, memorandum entitled “Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement.” The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new jobs, and provide new markets for farm commodities. According to the memorandum, the federal government, with leadership from the United States Department of Agriculture (USDA), has made significant strides in implementing the BioPreferred Program. The goal of the Presidential memorandum is to ensure that agencies effectively execute federal procurement requirements for biobased products.

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On February 22, 2012, the European Chemicals Agency (ECHA) issued a press release announcing that it is currently preparing an update of its Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) based on the European Commission’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIP-oN). Because the next registration deadline of May 31, 2013, is approaching quickly, ECHA “will facilitate compliance of all potential registrants well in advance.” ECHA intends to update the Guidance on IR & CSA later in 2012, in line with the outcomes of RIP-oNs 2 and 3. ECHA states that registrants may already find it useful to refer to the RIP-oN reports when preparing registration dossiers covering nanomaterials. ECHA reminds registrants, however, “to ensure that safe use of their substance should be demonstrated in the registration dossier, and hence that the data of the submitted properties as well as related risk assessment and management information should be applicable and appropriate for the nanoforms covered by the registration.” According to ECHA, the RIP-oN 1 report on the substance identification of nanomaterials also contains useful information that can be integrated into the IUCLID 5 manuals. Because the experience in addressing characterization of nanoforms is still developing, ECHA states it will not revise the current guidance on substance identity. Furthermore, ECHA notes, “for other areas it is clear that further scientific development and research are still necessary before providing definitive guidance updates.”

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The U.S. Environmental Protection Agency (EPA) announced in a February 13, 2012, Federal Register notice the availability of its Fall 2011 Regulatory Agenda. EPA’s Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in March 2012.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intends to publish an NPRM in March 2012.

 

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The Center for International Environmental Law (CIEL) published a report on February 6, 2012, entitled Just Out of REACH: How REACH Is Failing to Regulate Nanomaterials and How It Can Be Fixed. According to CIEL, there are four key gaps in the registration phase of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation:

• REACH does not define nanomaterials, and contains no nano-specific provisions;
• Most nanomaterials evade registration until 2018, yet they can still enter the European Union (EU) market;
• REACH’s schedule for registration hinges on the number of tonnes of a chemical, essentially missing all nanomaterials, which are generally produced in far smaller quantities; and
• REACH test guidelines fail to consider the special properties of nanomaterials.

CIEL proposes stand-alone regulation, aligned with REACH, but specifically tailored to nanomaterials. CIEL states that such a regulation “would establish clear, legally binding provisions for nanomaterials and create a transparent and predictable legal environment for the safe production and use of nanomaterials in the EU.”

 

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On February 9, 2012, the U.S. Environmental Protection Agency (EPA) posted a summary report on its January 2011 workshop on nanoscale silver. The workshop was the second in a series conducted by the National Center for Environmental Assessment (NCEA) to further the development of a research strategy for completing comprehensive environmental assessments of nanomaterials.  The basis of the workshop was the report Nanomaterial Case Study:  Nanoscale Silver in Disinfectant Spray.  According to the summary report, the outcomes of this and future workshops in the series -- prioritized information gaps and risk tradeoffs -- will be used in developing and refining a long-term research strategy to assess potential human health and ecological risks of nanomaterials and to manage associated risks of specific nanomaterials.

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The U.S. Environmental Protection Agency (EPA) has announced that, in response to public comments, it will provide the public more time to comment on the 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 “the comment period is being reopened until 45 days following publication of the new notice (until approximately mid-March).”  Importantly, the docket reveals that requests for extension were submitted by the International Center for Technology Assessment (ICTA), the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the United Automobile, Aerospace & Agricultural Implement Workers of America (UAW), and the United Steelworkers Union (USW).  The USW comment specifically asserts that the “specific protection measures required for individual PMN substances indicate that personal protective equipment, including gloves and respirators, should be the first line of defense to protect workers.  These requirements do NOT follow occupational health and safety best practices” (emphasis in original). The comment then goes on to cite the ANSI/AIHA Z10 2005 standard and the Occupational Safety and Health Administration (OSHA) standards as best practices.

This is an important perspective in the ongoing worker protection debate and the requests for comment deadline extension suggest that the unions are likely to become more engaged in this discussion.

 

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On March 27-28, 2012, the American Association for the Advancement of Science (AAA) will host the “International Symposium on Assessing the Economic Impact of Nanotechnology.” The Working Party on Nanotechnology (WPN) of the Organization for Economic Cooperation and Development (OECD), in collaboration with the U.S. National Nanotechnology Initiative (NNI), organized the Symposium. Lynn L. Bergeson is on the Steering Committee and will speak at the Symposium. The objective of the Symposium is to explore systematically “the need for and development of a methodology to assess the economic impact of nanotechnology across whole economies, factoring in many sectors and types of impact, including new and replacement products and materials, markets for raw materials, intermediate and final goods, and employment and other economic impacts.” Participants will address the scope of economic impacts of nanotechnology; input and output factors; metrics for other technological assessments; consideration of the appropriateness of these metrics for nanotechnology materials and products; the role of research funding portfolios; intellectual property frameworks; venture capital; public-private partnerships; state and local initiatives; international cooperation; and metrics such as private sector and industry investments, patents and publications, and the development of a technologically-educated workforce as metrics for nanotechnology. Attendees are being invited from a broad spectrum of backgrounds and expertise, including technology leaders, key decision makers, economists, investors, policy analysts, scientists and engineers from industry, business, government, academia, and the general public. Registration will open February 10, 2012, and will be on a first-come, first-served basis until the capacity is met. Positions are expected to fill quickly.

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On January 26, 2012, the Natural Resources Defense Council (NRDC) filed a lawsuit in the U.S. Court of Appeals for the Ninth Circuit against the U.S. Environmental Protection Agency (EPA) concerning its conditional registration of a pesticide product containing nanosilver as a new active ingredient for use as a preservative for textiles.  NRDC states that it seeks to limit public exposure to the nanosilver’s use in clothing, baby blankets, and other textiles. On December 1, 2011, EPA announced its conditional approval of HeiQ AGS-20.  As a condition of registration, EPA is requiring HeiQ to conduct a number of studies within four years, which EPA chose to allow time for protocol reviews prior to initiation of the studies, completion of the studies, and its review of the study results. NRDC states that it seeks to block EPA “from allowing nanosilver on the market without the legally-required data about its suspected harmful effects on humans and wildlife.”

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On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges.

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Lynn L. Bergeson will participate in a February 7, 2012, Bloomberg BNA webinar entitled “The Greening of Consumer Products:  Legal, Regulatory, and Strategic Considerations.” Bloomberg BNA states that the webinar is intended to help users:

• Identify the core concepts of green product development and the maturation of conventional environmental protection themes on which green product steward concepts rely;
• Describe the diversity of legal and regulatory authorities, domestic and international, that are relevant to chemical, industrial, and consumer product manufacturers from a legal compliance perspective;
• Analyze the role of private party standards and evolving concepts of product stewardship in product design and management;
• Address the trends and emerging themes embedded in the commercial value chain that must be monitored to be competitive and successful;
• Explore the challenges and value of green product marketing; and
• Develop basic strategies for legal compliance and commercial success in green product marketing.

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The NanoBusiness Commercialization Association, North Carolina Department of Commerce, and Center of Innovation for Nanobiotechnology will co-host the Nanotech Commercialization Conference on April 4-5, 2012, in Research Triangle, North Carolina. Lynn L. Bergeson will speak at the Conference, which will include:

• National-level keynote speakers;
• Sessions, workshops, and exhibits showcasing the latest advances in the field;
• Discussions on financing, licensing, and business development geared toward the nanotech entrepreneur;
• Sessions and exhibits showcasing cutting-edge research, products, and technologies; and
• Networking opportunities with connected professionals.

 

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On December 30, 2011, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs to Manage Nanomaterial Risks More Effectively. According to OIG, the purpose of its review was to determine how effectively EPA is managing the human health and environmental risks of nanomaterials. OIG states that it found “that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials.” According to OIG, although EPA has the statutory authority to regulate nanomaterials, it “currently lacks the environmental and human health exposure and toxicological data to do so effectively.” EPA proposed a policy, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), that would identify new pesticides being registered with nanoscale materials.  After “minimal industry participation” in EPA’s Nanoscale Materials Stewardship Program (NMSP), a voluntary data collection program, EPA has chosen to propose mandatory reporting rules for nanomaterials under FIFRA, and is developing proposed rules under the Toxic Substances Control Act (TSCA).

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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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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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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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ObservatoryNANO posted on November 24, 2011, a report on the nanotechnology environment, health, and safety (EHS) landscape. ObservatoryNANO, which is funded by the European Commission, intends to support European policy makers by providing scientific and economic analysis of nanoscience and nanotechnology developments. ObservatoryNANO notes that activity concerned with the EHS aspects of nanotechnologies has been growing for a decade.  ObservatoryNANO states that the aim of the EHS landscaping report is to provide a map and overview of key organizations and their activities within the field worldwide in relation to nano-EHS.  ObservatoryNANO intends the landscaping document to support communication of efforts, outlining those key initiatives, activities, and projects within the field.  According to ObservatoryNANO, because of the challenge of keeping track of the rapidly changing field, the landscaping document provides only a snapshot of efforts ongoing within 2011, and will change with time.

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On November 15, 2011, the Congressional Nanotechnology Caucus will host a briefing on the impact of nanotechnology on job creation. Topics to be addressed include the best ways to encourage private/public partnerships; what kind of jobs nanotechnology investment can create; and where private capital is investing money in nanotechnology. Guest speakers will include:

• Robert D. “Skip” Rung, President and Executive Director, Oregon Nanoscience and Microtechnologies Institute;
• Doug Jamison, Chief Executive Office, Harris & Harris; and
• Hilary Flynn, Lux Research.

The briefing will begin at 3:00 p.m. in Room 385 of the Russell Senate Office Building. To RSVP, please contact Matt Bormet.

 

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The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.’” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU) definition will be implemented in European legislation and in EU member states, and what companies can do in the short-term to offset the cost of long-term compliance.

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The U.S. Environmental Protection Agency (EPA) published in an October 26, 2011, Federal Register notice its final 2010 Effluent Guidelines Program Plan, which includes a request for comment and information for its 2011 annual reviews. EPA requests information on a number of topics, including discharges of nanosilver from industrial manufacturing. EPA cites nanosilver’s use as an active pesticide ingredient, an antimicrobial in fabric; a preservative in textile products, and coating in drums in washing machines. EPA states that, since many of these uses have the potential to create a source of silver in wastewater discharges, it “is interested in gathering as much information as possible on the fate, transport and effects of nanosilver on the aquatic environment and human health.” Comments on EPA’s 2011 reviews are due November 25, 2011.

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The Nanotechnology Caucus will hold a briefing on November 15, 2011, at 3:00 p.m. concerning jobs and nanotechnology. The briefing will focus on how targeted federal investments can lead to jobs down the road. More details will be forthcoming.

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On November 3, 2011, the European Chemicals Agency (ECHA) began a consultation on a testing proposal for multi-wall carbon nanotubes, synthetic graphite in tubular shape. Under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, manufacturers and importers must obtain information on toxic effects of substances.  REACH requires that new testing of a substance involving vertebrate animals be carried out only as a last resort, however. ECHA states that, to ensure that the best use has been made of existing information, it publishes all test proposals involving vertebrate animals for endpoints specified in Annexes IX and X under REACH.  After a testing proposal has been published, third parties have 45 days to submit “scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal.” The hazard endpoint for which vertebrate testing was proposed is long-term toxicity to fish. The deadline for submitting information is December 19, 2011. ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint.  ECHA publishes its responses to these contributions for the testing proposals after adoption of the related final decision.

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The European Commission (EC) began in 2009 a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Implementation Project on Nanomaterials (RIPoN), which it intended to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. The EC recently posted final reports concerning nanomaterials and information requirements (RIPoN 2) and chemical safety assessment (RIPoN 3). The EC states that, based on the scientific and technical state of the art with regard to nanomaterials, the reports were developed so that the advice on specific issues related to nanomaterials can be integrated into the existing REACH guidance documents. The EC notes that “inclusion of any of the advice from the reports into the [European Chemicals Agency (ECHA)] guidance is exclusively the responsibility of ECHA.  The presented reports do not represent ECHA guidance.” Nevertheless, the EC states, “while awaiting the official guidance up-date, companies are invited to consult the two reports and take the recommendations into account as appropriate when preparing or updating REACH registration dossiers and evaluating hazard information for potential classification under CLP.” The EC also posted a third report on substance identity. The EC cautions, however, that since it was not possible to reach consensus amongst the experts on the recommendations in the third report, “further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.”

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The U.S. Environmental Protection Agency (EPA) posted a September 2011 guidance document entitled Guidance to Facilitate Decisions for Sustainable Nanotechnology, which was prepared by the National Risk Management Research Laboratory of the Office of Research and Development. EPA states that it developed the guidance to assist in assessing the sustainability of nanoproducts, and it is intended “to lay the groundwork for developing a decision-support framework through continual updates as research in this area progresses.”  The foundation of EPA’s approach, according to the guidance, is to consider existing standards and methods for environmental, economic, and social assessments using a life cycle perspective and offer guidance by relaying first-hand knowledge of applying assessment tools to nanotechnologies, whenever possible.  The guidance includes overviews of various assessment methodologies to help stakeholders make informed choices when selecting tools appropriate for their goals.  According to EPA, the key steps to be included in the evolving framework include:  characterizing a nanoproduct and identifying potential risks and impacts; identifying relevant stakeholders; defining the goal and scope of an assessment; assessing environmental, economic, and social impacts; evaluating sustainability criteria; developing and evaluating alternatives; and selecting and implementing a decision to support sustainability.  EPA will review and update the guidance as additional information becomes available.

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On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2) human exposure assessment; (3) human health; (4) environment; (5) risk assessment and risk management methods; and (6) informatics and modeling. The Strategy also considers the ethical, legal, and societal implications (ELSI) of nanotechnology. NNI held a webinar on October 20, 2011, to announce the release of the Strategy, and Lynn L. Bergeson served on the panel. The Strategy, fact sheet, brochure, and webinar are available online.  NNI will post the panelist materials.

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The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”:

2.         “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

3.         By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

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The National Nanotechnology Initiative (NNI) will hold a webinar on October 20, 2011, to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy, and to discuss the development of the Strategy and its key focus areas. Dr. John Howard, Co-Chair of the Nanotechnology Environmental and Health Implications (NEHI) Working Group, will serve as the moderator. Panelists will include:

• Dr. Treye Thomas, NEHI Working Group Co-Chair;
• Dr. Shaun Clancy, Evonik DeGussa Corporation;
• Dr. Janet Carter, Occupational Safety and Health Administration (OSHA); and
• Lynn L. Bergeson, Bergeson & Campbell, P.C.

The webinar will include a 20-minute question-and-answer segment following the presentations.

 

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On October 11, 2011, Health Canada announced the availability of its Policy Statement on Health Canada’s Working Definition for Nanomaterials. Health Canada received 29 comments from stakeholders on its March 2010 Interim Policy Statement, which it revised based on stakeholders’ feedback. According to Health Canada, other revisions were prompted by developments in international norms, evolving scientific evidence, and regulatory program needs. Health Canada states that it will update its Policy Statement “as the body of scientific evidence and international norms progress.” The Policy Statement on Health Canada's Working Definition for Nanomaterial, summary of comments received, and frequently asked questions are available online.

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On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications of using nanotechnology in everyday products and develop best practices for companies using nanotechnology. The legislation would authorize $48 million over three years, beginning in fiscal year 2013. In his press release, Pryor noted that the FDA already has facilities in place, such as the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas, that could conduct the scientific studies required by the bill. Pryor stated that there are over 800 known commercial uses of nanotechnology and over 1,300 consumer nanotechnology products available. The bill was referred to the Committee on Health, Education, Labor, and Pensions.

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The European Commission (EC) has asked the Scientific Committee on Consumer Safety (SCCS) to prepare a guidance document on the safety assessment of nanomaterials in cosmetics. In its request for guidance, the EC notes that a number of documents provide general guidance on the health risk assessment of manufactured nanomaterials, but experience with the assessment of specific substances is limited. The guidance, which is due February 2012, should address the essential elements that would be required in a manufactured nanomaterial safety dossier (i.e., physicochemical characterization, toxicological evaluation, exposure assessment). According to the EC, the guidance will facilitate the submission of safety dossiers at present, as well as assist in the implementation of the provisions of Article 16 of the Cosmetics Regulation (EC) No. 1223/2009/, “which will impose strict conditions and timelines for the notification and the assessment of cosmetic products containing nanomaterials on the responsible persons and the SCCS respectively, starting on January 2013.”

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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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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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Earlier this month the Danish Environmental Protection Agency (DEPA) published a document entitled Survey on Basic Knowledge about Exposure and Potential Environmental and Health Risks for Selected Nanomaterials, which is intended to provide an overview of the existing knowledge about seven of the most common nanomaterials, their environmental and health properties, the use of those nanomaterials, and the possibility of exposure of humans and the environment.  DEPA selected fullerenes, iron, silver, nanoclay, and titanium, cerium, and silicon dioxides for the project.  Based on current uses, DEPA concluded that current applications of nano-iron and nano-clay cannot cause unexpected “nano-associated” health or environmental problems.  Although DEPA identified no specific risk associated with current uses of any of the identified nanomaterials, it concluded “there are areas where there may be reason for attention and thus need for more knowledge.”

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The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities.  FDA notes that rapid advances in innovative science have provided new technologies to discover, manufacture, and assess novel medical products, and to improve food safety and quality. To keep pace with and use these new scientific advances, FDA developed the Strategic Plan. According to the Strategic Plan, one of the ways FDA intends to support new approaches to improve product manufacturing and quality is by developing new analytical methods, including improved methods and tools to detect and measure the physical structure, chemical properties, and safety of engineered nanomaterials in FDA-regulated products. The priority area entitled “Ensure FDA Readiness to Evaluate Innovative Emerging Technologies” includes the following statement regarding nanotechnology:

As medical products are being revolutionized by cutting-edge technologies like nanotechnology, it is more critical than ever for FDA to fully understand how nanomaterials are being used in these products.  FDA has established Nanotechnology Core Centers to provide critically needed equipment and technical staff to conduct product assessment and safety research in support of regulatory decision making.  These centers will facilitate investigations on the safety of products that use nanomaterials, establish methods to assess quality and effectiveness of products that use nanomaterials, and identify standards to be incorporated in the preclinical safety assessment of products that contain nanomaterials.

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The National Nanotechnology Initiative (NNI) has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:

• Significant discussion about environmental, health, and safety (EHS) questions for nanotechnology-enabled products;
• Hands-on participation in joint programs of work that will better leverage resources; and
• Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.

 

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Representative Mike Honda (D-CA) re-introduced on August 1, 2011, the Nanotechnology Advancement and New Opportunities Act (NANO Act), which seeks to promote the development and responsible stewardship of nanotechnology in the U.S. According to Rep. Honda, the legislation is designed to maintain the U.S.’s leadership role in nanotechnology research by promoting the development and commercialization of the results. At the same time, the NANO Act addresses concerns raised about the potential health and safety risks associated with nanotechnology. It would require the National Nanotechnology Coordination Office (NNCO) to develop a report for Congress outlining a national nanotechnology development strategy after consulting with relevant federal agencies, including the U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health and Safety (NIEHS), and National Institute of Occupational Safety and Health (NIOSH) on nanotechnology’s potential risks. Through creation of research priorities for the federal government and industry that will help ensure development and responsible stewardship, the NANO Act looks to remove uncertainty about risk and future federal regulation -- resolving uncertainty as one of the major obstacles to commercialization. The NANO Act also includes provisions to create partnerships, raise awareness, and implement policies promoting nanotechnology, including public-private investment partnerships; grant programs supporting research and education; tax credits for investments, education, and training in nanotechnology; and directing the National Science Foundation (NSF) to partner with industry to encourage development of training to support nanotechnology manufacturing.

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The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) of their intent to issue voluntary guidance to industry on nanotechnology products as “a small, but encouraging first step toward regulation.”

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The Office of Environmental Health Hazard Assessment (OEHHA) announced on July 29, 2011, that it revised its proposed regulation concerning the specification of hazard traits, environmental and toxicological end-points, 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. Comments are due September 12, 2011.

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Comments on the U.S. Environmental Protection Agency’s (EPA) proposed policy on nanoscale materials in pesticide products are due August 17, 2011. EPA offers two approaches for obtaining the information EPA believes it needs concerning nanoscale materials in pesticide products. Under the first approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. EPA states that it would “prefer” to use this approach, despite industry’s concern over the use of the “adverse effects” reporting provision to obtain information. Under the second approach, EPA would use a data call-in (DCI) under FIFRA Section 3(c)(2)(B). EPA also proposes to apply an initial presumption that active and inert ingredients that are the nanoscale versions of non-nanoscale active and inert ingredients already present in registered pesticide products are potentially different from those conventionally sized counterparts. Registrants could rebut this initial presumption on a case-by-case basis.

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The U.S. Environmental Protection Agency’s (EPA) July 7, 2011, Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2011.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intended to publish an NPRM in June 2011. Nothing has been published to date, however.

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The U.S. Environmental Protection Agency (EPA) is expected to publish a Federal Register notice on July 13, 2011, extending the comment period concerning possible approaches for obtaining information about what nanoscale materials are present in registered pesticide products until August 17, 2011. EPA states that it received requests from CropLife America, the Biocides Panel of the American Chemistry Council, the Chemical Producers & Distributors Association, and the International Center for Technology Assessment. The NanoBusiness Commercialization Association (NanoBCA) also requested a 90-day extension of the comment period, which was not granted.

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The recast of the Directive on the Restriction of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more “environmentally friendly alternatives” as soon as scientific evidence is available, and taking into account the precautionary principle. The notice specifically states that these “other hazardous substances” include “any substances of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure.” Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and were not included in the version of the legislation passed by both the EU Council and European Parliament (EP).

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Today Senator John D. Rockefeller IV (D-WV), Chair of the Senate Commerce Committee, announced that the Science and Space Subcommittee will hold a hearing on July 14, 2011, at 10:00 a.m. (EDT) on national nanotechnology investment. According to Rockefeller’s July 1, 2011, press release, as the Commerce Committee considers a reauthorization of the National Nanotechnology Initiative (NNI), the hearing will examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments.

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The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials” for discussion during the June 21, 2011, meeting of the Environment Council of the European Union (EU).  The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” The current legislation is intended, however, “to assess the hazards of chemical substances used in products, such as cosmetics, but is not geared to evaluating the specific hazards related to nanoengineered particles.” According to the delegation, a key problem is the lack of a generally accepted definition of what constitutes a nanomaterial. The paper calls on the European Commission (EC) to take three steps to regulate nanomaterials: (1) reach agreement on a broadly applicable definition of nanomaterials that covers as many materials with nanospecific risks as possible; (2) ensure traceability and enable a fast and adequate response should a specific nanomaterial ever be found to be hazardous; and (3) develop an adequate risk assessment system for nanomaterials and for products with nanoscale features, and, where necessary, of risk control measures. The paper urges the EU to take action, rather than member states, to prevent industry from facing non-harmonized definitions of nanomaterials, different substance databases, additional administrative costs, and possible market restrictions for certain materials or products. The paper notes that, in the absence of such measures, however, member state initiatives “may be necessary to protect health and the environment.”

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The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Russell Senate Office Building. Please note that the location has been corrected.

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The U.S. Enviromental Protection Agency (EPA) published in the June 17, 2011, Federal Register a notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act, even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments are due July 18, 2011.

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The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Dirksen Senate Building. The agenda includes:

• Opening Remarks: Vincent Caprio, Executive Director, NanoBusiness Commercialization Association;
• Senator Ron Wyden (D-OR);
• Sally Tinkle, Ph.D., Acting Director, National Nanotechnology Coordination Office, Nanoscale Science, Engineering, and Technology Subcommittee, Committee on Technology National Science and Technology Council;
• Travis Earles, Ph.D. (Invited), Advanced Materials and Nanotechnology Initiatives, Lockheed Martin Corporation (formerly Assistant Director of Nanotechnology, White House Office of Science and Technology Policy);
• Jim Hussey, CEO, NanoInk;
• Frank Ignazzitto, Vice President, Government Business, QD Vision, Inc.;
• Ajay Malshe (Invited), Co-Founder and Chief Technology Officer, NanoMech; and
• Scott Livingston, Chairman and CEO, Livingston Securities.

To RSVP, please contact Vincent Caprio.

 

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On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials” that occur at the agency level. According to OSTP, the principles reinforce the overarching principles for the regulation and oversight of emerging technologies released on March 11, 2011. The principles also reflect recommendations from a report on nanotechnology prepared by the President’s Council of Advisors on Science and Technology and, importantly, reflect the results of a multi-agency, consensus-based process lead by the National Economic Council (NEC), the Office of Management and Budget (OMB), OSTP, and the Office of the U.S. Trade Representative (USTR). OSTP states that the goals of all of these documents “are to achieve consistent approaches across different emerging technologies and to ensure the protection of public health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.”

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The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers (nm).” Under one approach, EPA would use Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. Under an alternative approach, EPA would obtain such information using a data call-in (DCI) under FIFRA Section 3(c)(2)(B). According to the notice, EPA believes FIFRA Section 6(a)(2) “is the most efficient and expedient administrative approach to obtaining information about nanoscale materials in pesticides and EPA would prefer to use this approach.” The notice also proposes a “new approach” that EPA will use to determine on a case-by-case basis whether a nanoscale active or inert ingredient is a “new” active or inert ingredient for purposes of FIFRA and the Pesticide Registration Improvement Act (PRIA), even when an identical, non-nanoscale form of the nanoscale ingredient is already registered. Comments will be due 30 days after the notice is published in the Federal Register.

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On May 26, 2011, the Organization for Economic Cooperation and Development (OECD) posted a document entitled “Current Developments/Activities on the Safety of Manufactured Nanomaterials,” which provides information on the outcomes and developments of the OECD Working Party on Manufactured Nanomaterials (WPMN) related to the safety of manufactured nanomaterials. OECD states that the document “provides a snapshot of information on current/planned activities related to the safety of manufactured nanomaterials in OECD member countries and other delegations that attended the 8th meeting of OECD’s Working Party on Manufactured Nanomaterials (Paris France, 16-18 March 2011).” The document also includes written reports on current activities from other international organizations such as the International Organization for Standardization (ISO), Food and Agriculture Organization of the United Nations (FAO), and World Health Organization (WHO).

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The June 6-8, 2011, Technical Association of the Pulp and Paper Industry (TAPPI) International Conference on Nanotechnology for Renewable Materials will include a “Lunch-n-Learn” session on June 6, 2011, from 12:00-1:00 p.m. (EDT). During the luncheon, which will be held in Washington, D.C., in Senate Visitors Center Room 201, TAPPI will introduce a Public-Private-Partnership model and its job creation potential in U.S. utilizing renewable nanocellulose materials. TAPPI will present leading edge research and development projects to help understand the significant impact federal investments give to keep the U.S. a global leader in manufacturing into the 21st century. RSVPs are due by 5:00 p.m. (EDT) on May 31, 2011.

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The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment's (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17, 2011, on nanosilver. SNWG states that, despite BfR’s assurance that follow-up dialogue would occur after the workshop, BfR instead issued its April 12, 2011, statement, which restated BfR’s initial opinion.  According to SNWG, BfR has “essentially ignore[d] the facts presented to BfR during the workshop.” SNWG reviews BfR’s concerns regarding nanosilver -- the use of silver aims to replace normal hygiene measures, the potential for bacterial resistance from silver, and claims of unusual effects of nanosilver -- and addresses each. SNWG highlights the benefits to consumers from antimicrobial products, including longer shelf-life and protection from the degrading action and colonization of bacteria. SNWG notes that BfR disregarded multiple references regarding the low risk of resistance to silver and wrongly singled out nanosilver to address a concern about silver resistance in general. Finally, SNWG rebuts BfR’s assumptions concerning the use of silver and nanosilver, and concludes that the “mode of action is therefore not unusual in comparison to other silver forms employed in the marketplace or used throughout history.” SNWG describes additional issues of concern regarding BfR’s position on nanosilver, including its misunderstanding of materials and history; the selective harm to small- and medium-sized enterprises; and its preemption of the European Union regulatory process.

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In a May 2011 letter, Representatives Ralph M. Hall (R-TX) and Eddie Bernice Johnson (D-TX) ask Congressional members to join the bipartisan and bicameral Congressional Nanotechnology Caucus. The Caucus was formed over ten years ago and is intended to inform legislators about nanotechnology issues, including the effect of nanotechnology on job creation and other economic benefits to the U.S. The National Nanotechnology Initiative (NNI), which was codified by Congress in 2003, coordinates the federal nanotechnology research and development of 25 federal agencies. Since enactment, the House has passed bills in the 110th (H.R. 5940) and 111th (H.R. 554 and H.R. 5116) Congresses to amend and reauthorize the NNI, but the Senate did not act in either Congress. Since fiscal year 2008, the NNI has received funding through annual appropriations bills. Nanotechnology stakeholders are urged to use this template letter to let their representatives and senators know of the importance of nanotechnology issues to their constituents and urge them to participate in the Caucus.

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The International Organization for Standardization (ISO) has published a new standard, ISO/TR 13121:2011, which describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials to protect the health and safety of the public, consumers, workers, and the environment.  According to ISO, the standard offers guidance on the information needed to make sound risk evaluations and risk management decisions.  The standard also includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders. The standard offers methods organizations can use to be transparent and accountable in how they manage nanomaterials, and describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials.

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The European Chemicals Agency (ECHA) is compiling an inventory of nanomaterials included in the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossiers and Classification, Labeling, and Packaging (CLP) notifications for the European Commission (EC), and intends to deliver the inventory by the end of June 2011. The EC requested the inventory in response to the 2009 European Parliament communication on nanomaterials. An ECHA spokesperson stated that detailed results from the inventory would be available towards the end of 2011, and the inventory may be disseminated at a later date, but this has not yet been discussed. According to the spokesperson, ECHA has found three registration dossiers and 14 CLP notifications in which “nanomaterial” was selected as the form of the substance. The spokesperson stated that ECHA will be able to identify 50-60 REACH registration dossiers that include information on nanomaterials that will be sent to the Joint Research Centre for assessment under a separate project to address if and how information on nanomaterials is included in REACH registration dossiers.

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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. According to EFSA, the guidance “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. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”

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Last week, the University of California, San Francisco’s (UCSF) Program on Reproductive Health and the Environment announced the publication of its “Recommendations for Addressing Potential Health Risks from Nanomaterials in California,” which provides recommendations for addressing potential health risks from nanomaterials to the Office of Environmental Health Hazard Assessment (OEHHA) and to the state of California.  OEHHA contracted with UCSF to prepare the report, which provides an overview of nanotechnology materials, potential exposures, and human-health risks, and recommendations for addressing potential health hazards and risks from nanotechnology. Recommendations include those that can be implemented under the existing regulatory structure of OEHHA, such as establishing a publicly accessible clearinghouse and inventory of nanomaterial sources and products. The report also includes recommendations that are outside the scope of OEHHA, many of which may require legislative changes, such as requiring testing of release and exposure potential for nanomaterials in existing and new consumer products, and implementing a labeling system that requires labeling of products that contain nanomaterials.  According to UCSF, the recommendations primarily focus on requiring information on potential exposures and health hazards for nanomaterials used in the marketplace.

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On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the final rule is necessary “because the chemical substance may be hazardous to human health,” and the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule will be effective June 6, 2011.

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In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports.  Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to greater trade and investment between the U.S. and EU “are not tariffs or quotas, but rather differences in regulatory measures.” The ITA seeks public input to help identify divergences in regulatory measures in the transatlantic marketplace, “so that the U.S. Government can work cooperatively with the European Union to address them.” This notice offers an important opportunity to educate the ITA on subtle, yet significant trade impacts that are derivative of regulatory and/or competitive issues. ITA also seeks recommendations for existing or emerging industry or product sectors that may benefit from regulatory cooperation between the U.S. and the EU. ITA asks that submitters be as specific as possible in describing the relevant product or product sector in which they believe there is an opportunity to facilitate trade without undermining U.S. public health, safety, environmental, and other legitimate policy objectives. ITA states that it is interested in receiving recommendations concerning any product sector that, due to the volume of trade between the U.S. and EU, “is a justifiable focus of enhanced regulatory cooperation.” Comments are due June 2, 2011.

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On April 12, 2011, the German Federal Institute for Risk Assessment (BfR) issued a statement entitled “Safety of Nano Silver in Consumer Products: Many Questions Remain Open,” which reports BfR’s conclusions from a February 2011 workshop discussing existing risks and possible options for comprehensive consumer protection from nanosilver. According to BfR, “the situation continues to be characterised by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available.” BfR states: “Articles of daily use and consumer products may not constitute any health risk based on statutory provisions during proper use or foreseeable misuse. Since no final safety assessment for man and the environment is available so far for nanoscale forms of silver due to the missing data, BfR continues to advise against a broad use of nano silver in consumer products.”

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On April 6, 2011, several members of the NanoSafety Consortium submitted to the U.S. Environmental Protection Agency (EPA) a proposed testing agreement under Section 4 of the Toxic Substances Control Act (TSCA). Under the proposed testing agreement, the substances to be tested may include multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. Participants would conduct 90-day inhalation toxicity studies in rats, and submit interim progress reports to EPA at 60-day intervals, and a final report within 120 days of the conclusion of testing. Under the proposed testing agreement, if EPA promulgated a TSCA Section 5(a)(2) significant new use rule (SNUR) applicable to the test substances, then the testing agreement would have the status of a TSCA Section 5(b)(1)(A) test rule. The NanoSafety Consortium asked that EPA “expeditiously consider” the proposed testing agreement and begin the public comment and negotiation process at its “earliest possible convenience.”

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On April 14, 2011, the House Committee on Science, Space, and Technology Subcommittee on Research and Science Education will hold a hearing entitled “Nanotechnology:  Oversight of the National Nanotechnology Initiative and Priorities for the Future.” Witnesses will include:

• Dr. Clayton Teague, Director, National Nanotechnology Coordination Office;
• Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
• Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
• Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
• Mr. William Moffitt, President and CEO, Nanosphere, Inc.

 

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The European Parliament (EP) and European Union (EU) Council failed to reach agreement on an update to the novel foods regulation, which would have updated the 1997 regulation to address several issues, including nanoscale ingredients in food. According to a March 29, 2011, press release, the EP and Council disagreed on labeling food from cloned animals and their descendents, as well as nanotechnology. The draft legislation passed by the EP in July 2010 would have banned nanoscale ingredients from food until the risks posed are better understood, and would have required that any nanoscale ingredients eventually authorized be clearly labeled as such. The EP issued a March 29, 2011, statement, which notes that the failure to reach an agreement on the legislation means “[t]here will continue to be no special measures regarding nanomaterials in food, for example.”

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On March 25, 2011, the National Research Council (NRC) announced the availability of a report entitled Prudent Practices in the Laboratory, which updates NRC’s guidelines on the safe use of hazardous chemicals. NRC last updated the guidelines in 1995, and the new edition includes new topics, including the handling of nanomaterials. The update sets out general guidelines for the management of nanomaterials. NRC developed the guidelines “from accepted chemical hygiene protocols for handling compounds of unknown toxicity.” The guidelines cover topics such as planning and assessing the hazards of nanomaterial work, information on grading the risk of working with different types of nanomaterial, and suggestions on ways to make sure the working environment is designed to protect laboratory personnel from exposure to nanoparticles.

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According to a March 10, 2011, press release, the risks connected with nanomaterials are one of the areas on which the Swedish Chemicals Agency (KemI) will focus in its national action plan, which will apply from 2011-2014. The press release states that the objective is for Sweden “to become one of the leading member states in the [European Union (EU)] in proposing new bans and restrictions.” Sweden expects the action plan to “lead to intensified cooperation and dialogue with other government agencies, industry, researchers, environmental and consumer organisations.” In December 2010, the Swedish government commissioned KemI to produce a “national action plan for a toxin-free everyday environment.” KemI intends to focus on children “as they are more vulnerable to the influence of chemicals.” KemI will examine EU legislation and work to strengthen it to limit the presence of hazardous chemicals in products. KemI states that companies that manufacture and import products “should to a larger extent substitute hazardous chemicals, and they will be supported in these efforts.” KemI intends to expand enforcement activities in the form of inspection of articles.

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In February 2011, the Dutch Environmental Safety and Risk Management Directorate sent a letter to the Directorate General (DG) Enterprise and DG Environment expressing concern regarding delays in the work of the Competent Authorities Sub-Group on Nanomaterials (CASG Nano) and the European Commission’s (EC) progress regarding clarifying the definition and status of nanomaterials. The Dutch Directorate states that an essential first step is to define what nanomaterials are and asks that the EC propose a common definition to member states as soon as possible, and in time for it to be discussed at the Competent Authorities for REACH and Classification and Labeling (CARACAL) meeting scheduled for mid-2011. According to the Directorate, the definition should be sufficiently broad to ensure all substances that present a nano-related risk are covered. The Directorate also asks that the three Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) implementation projects on nanomaterials be completed before the CARACAL meeting and that the EC provide greater clarity on the criteria necessary to assess whether nanomaterials pose specific risks. The Dutch competent authority is considering which substances to propose for substance evaluation under REACH and intends to include a nanomaterial. While the evaluation would not begin until 2012, the Dutch competent authority states that it would still be valuable to provide information on which elements of REACH remain problematic in terms of assessing hazards and risks associated with nanomaterials.

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On March 7, 2011, the National Institute for Occupational Safety and Health (NIOSH) announced that it seeks comment on the types of hazard identification and risk management research that it should consider in updating the NIOSH 2009 nanotechnology strategic plan. According to the Federal Register notice, NIOSH would like to build on the accomplishments of ongoing research to develop strategic research goals and objectives through 2015. Comments are due April 15, 2011.

Continue Reading...

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On February 11, 2011, the European Union (EU) Regulatory Committee voted to adopt revised environmental criteria for hand dishwashing detergents and all-purpose cleaners and cleaners for sanitary facilities. The Committee supported a European Commission (EC) proposal not to exclude nanomaterials from products awarded the voluntary EU ecolabel, despite concerns from members states, including Austria, Germany, France, Denmark, Slovakia, and Poland, as well as Norway. The EC proposed that the definition of nanomaterials should be established before a ban is introduced. According to the adopted text, “nanoforms” should comply with the existing criteria on hazardous substances.

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On February 14, 2011, the Organization for Economic Cooperation and Development (OECD) published a booklet entitled Nanosafety at the OECD: The First Five Years 2006-2010, which covers highlights of activities, priority areas, and major outcomes, as well as outreach in dealing with safety issues arising from manufactured nanomaterials. Regarding next steps, OECD states that its research and development program regarding manufactured nanomaterials is “processing rapidly,” so the program remains flexible to address emerging issues in a “timely and resource efficient way.”  OECD states: “There is still much to learn to fully understand how to work safely with some nanomaterials.  However, if countries continue to work together in the OECD, as they have started to do, this should ensure that the human health and environmental safety aspects are addressed appropriately and efficiently at the same time, as the economic opportunities of the technology advance.”

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Under the fiscal year (FY) 2012 budget request submitted by President Obama to Congress on February 14, 2011, funding for the National Nanotechnology Initiative (NNI) would increase by $201 million, to $2.1 billion. According to an Office of Science and Technology Policy (OSTP) fact sheet, agencies participating in the NNI have developed three signature initiatives in areas ready for advances through close and targeted program-level interagency collaboration: Nanoelectronics for 2020 and Beyond; Sustainable Manufacturing: Creating the Industries of the Future; and Nanotechnology for Solar Energy Collection and Conversion. Participating agencies will continue to support nanoscience and nanotechnology development through investigator-led research; multidisciplinary centers of excellence; education and training; and infrastructure and standards development. In addition, OSTP states, agencies will still maintain a focus on the responsible development of nanotechnology, with attention to potential human and environmental health impacts, as well as ethical, legal, and other societal issues. At a February 14, 2011, news briefing for reporters, OSTP Director John Holdren said budget reductions proposed by Republicans in Congress could be damaging if applied to federal research funding.

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This week the National Nanotechnology Initiative (NNI) and the White House Office of Science and Technology Policy (OSTP) released the 2011 NNI Strategic Plan. According to NNI, the Plan retains the “overall vision,” four goals, and eight program component areas outlined in the previous edition of the Plan, which was released in December 2007. For the first time, the Plan includes specific objectives under each goal, outlining concrete steps that NNI member agencies will take toward collectively achieving the NNI vision and goals.  NNI member agencies will use the Plan to guide the coordination of their research, training programs, and resources. NNI states that the Plan incorporates a broad rage of stakeholder input obtained through NNI-sponsored workshops, a formal Request for Information published in the Federal Register, and the NNI Strategy Portal website.

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On January 31, 2011, State Secretary for Infrastructure and the Environment, Joop Atsma, announced that joint investments in the development of nanotechnology made by the public and private sectors in the Netherlands must devote at least 15 percent of the investment to risk analyses. According to a spokesperson, the new requirement includes an €80 million ($110.4 million) investment approved by the previous government and matched by the private sector. The independent Committee for Societal Dialogue on Nanotechnology recently released a report that found citizens have a positive attitude about the opportunities offered by nanotechnology, but are concerned about the risks.

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The South Korean Ministry of Environment released on January 18, 2011, the National Chemicals Control Basic Plan, which it intends to help it implement the United Nations’ sustainable chemical control rules under the 2006 Strategic Approach to International Chemicals Management (SAICM). According to the Ministry, the Plan will reduce the amount of human carcinogens released into the environment annually by 32 percent by 2020, and will expand the national toxicity information database by 2020 to cover 34,000 chemical substances, or 80 percent of some 43,000 known to be in circulation, up from the current level of 15 percent. Under the Plan, nanosubstances are among priority chemicals that will be subject to in-depth hazard assessment, exposure analysis, and safety studies.

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The European Commission (EC) announced that it will hold the fourth annual Nanotechnology Safety for Success Dialogue Workshop on March 29-30, 2011, in Brussels, Belgium. According to the EC, many market modelers identify nanotechnologies as drivers of economic growth, and as a consequence, many governments have adopted ambitious plans intended to ensure the commercial success of nanotechnologies. At the same time, the number of potential and real applications is increasing rapidly.  The international community has organized itself to address the potential safety aspects of nanomaterials, in particular under the auspices of the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials, and with the support of national and European scientific advisory bodies like the EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).  A number of regulatory developments have taken place while the science was also advancing.  The EC is convening the Workshop to:

 

• Take stock of the fast advancing science needed for appropriate and effective policies; and
• Analyze how these advances allow progress with respect to intelligence gathering, risk assessment, risk management, and safe design.

 

Registration to participate on location or via web streaming is open until March 1, 2011.

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On January 10, 2011, Environmental Science & Technology posted a peer-reviewed pre-publication article entitled “120 Years of Nanosilver History:  Implications for Policy Makers,” which shows that nanosilver in the form of colloidal silver has been used for more than 100 years and, according to the authors, has been registered as a biocidal material in the U.S. since 1954.  The article states that 53 percent of the U.S. Environmental Protection Agency (EPA)-registered biocidal silver products likely contain nanosilver and most of the applications are silver-impregnated water filters, algicides, and antimicrobial additives that do not claim to contain nanoparticles.  The authors state: “The implications of this analysis for policy of nanosilver is that it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a bid to declare nanosilver materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature to the term ‘nano.’”

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On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011.

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B&C Consortia Management, L.L.C. (BCCM) is working with BASF Corporation (BASF) to create a consortium to provide the California Department of Toxic Substances Control (CDTSC) information on analytical methods that could be used to measure certain nanoscale materials in air, surface water, and soil.  The collaborative project will involve adapting known methods used to measure these substances in other media to the analysis of environmental media.  The term of the consortium will be at least two years, which can be modified by mutual agreement. On December 21, 2010, CDTSC issued a data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. Experts within BASF will address issues concerning titanium dioxide and zinc oxide. BASF and BCCM seek other companies and experts to offer similar expertise for the remaining nanomaterials of interest and provide CDTSC with the help it needs.

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On December 17, 2010, ETC Group published a report entitled The Big Downturn?  Nanogeopolitics, which updates its 2005 nanogeopolitics survey. According to ETC Group, since 2005, policymakers have begun to acknowledge that fast-tracking nanotechnology has come at a price and that some sort of regulation is necessary to address at least some of the risks posed.  ETC Group states, though, that “governments and industry, hand in hand, have come too far and invested too much to give up on nanotech’s promise of becoming the strategic platform for global control of manufacturing, food, agriculture and health -- a pillar of the 21st century’s ‘green economy.’”  ETC Group provides an update on the geopolitical landscape, producing a current snapshot of global investment, markets, governance, and control, including intellectual property. ETC Group is hopeful that the risks of nanotechnology will be addressed in fora such as the International Labour Organization (ILO) XIX World Congress on Safety and Health at Work in Istanbul in September 2011 and the United Nations (UN) Rio+20 Summit in 2012.

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On December 28, 2010, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010 (H.R. 5116) was presented to President Obama for signature. The bill, as unanimously passed by the Senate on December 17, 2010, does not include reauthorization of the National Nanotechnology Initiative (NNI). The House passed similar legislation on May 28, 2010, by a vote of 262-150. The House bill would have reauthorized the NNI. The Senate version, on the other hand, contains no reference to nanotechnology.

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The U.S. Environmental Protection Agency’s (EPA) December 20, 2010, Regulatory Agenda includes several notices concerning nanoscale materials:

• Test Rule for Certain Nanoscale Materials -- EPA states that it is developing a test rule under Section 4(a) of the Toxic Substances Control Act (TSCA) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in April 2011.
• Reporting Under TSCA Section 8(a) -- Under TSCA Section 8(a), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials.  According to the notice, the rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice states that EPA intends to issue an NPRM in February 2011. EPA submitted a proposed rule to the Office of Management and Budget (OMB) for review on November 22, 2010.
• Significant New Use Rule (SNUR) -- EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2).  The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. EPA intends to issue an NPRM in February 2011.

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Australia’s National Industrial Notification and Assessment Scheme (NICNAS) recently issued guidance on the new chemical requirements for the notification and assessment of industrial nanomaterials that are considered to be new chemicals. The new administrative arrangements will be effective from January 1, 2011, and will apply to any new chemical that falls under the following working definition of “industrial nanomaterial”:

. . . industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer (nm)] and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).

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The Switzerland State Secretariat for Economic Affairs (SECO) has posted a December 21, 2010, guidance document for preparing safety data sheets (SDS) for synthetic nanomaterials. Safety Data Sheet (SDS): Guidelines for Synthetic Nanomaterials is intended to demonstrate the information necessary to ensure the safe handling of nano-objects and products that contain nano-objects; offer assistance on how the relevant information can be identified and in which form and which place they are to be listed in the SDSs; and contribute to making employees of companies that produce or process synthetic nano-objects aware of the particular properties of these materials. The Guidelines, which are limited to “specifically manufactured (i.e. synthetic) nano-objects which are nano-sized in two or three dimensions (i.e. nano-fibres or nano-particles),” include two fictitious examples of SDSs for synthetic nanomaterials. The Guidelines supplement the Federal Office of Public Health (FOPH) document entitled The Safety Data Sheet in Switzerland.

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On December 21, 2010, the California Department of Toxic Substances Control (CDTSC) issued a data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. According to CDTSC, Health and Safety Code Section 57018(a)(4) defines a “manufacturer” as a “person who produces a chemical in this state or imports a chemical into this state for sale in this state.”  Accordingly, CDTSC states, “persons and businesses who produce or import one or more of the above chemicals, in any quantity, must comply with the statute and this request.” CDTSC requests information about the analytical test methods that identify and quantify the specified nanomaterials, their metabolites, and their degradation products in water, air, soil, sediment, sludge, chemical waste, fish, blood, adipose tissue, and urine. CDTSC states it determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists.  To better understand the behavior, fate, and transport of these nanomaterials, CDTSC needs “appropriate analytical test methods” for manufacturers, contract and reference laboratories, and regulatory agencies.  CDTSC states that manufacturers “may be required to develop information consistent with the requirements of Health and Safety Code section 57019(c) and (d).” Manufacturers, including importers, must provide the requested information no later than one year from CDTSC’s December 21, 2010, letter, however, “timely attention and response is preferred.”

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On December 8, 2010, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) approved its opinion on the scientific basis for the definition of the term “nanomaterial.” The opinion concludes that:

• Whereas physical and chemical properties of materials may change with size, there is no scientific justification for a single upper and lower size limit associated with these changes that can be applied to define adequately all nanomaterials;
• There is scientific evidence that no single methodology (or group of tests) can be applied to all nanomaterials; and
• Size is universally applicable to define all nanomaterials and is the most suitable measurand. Moreover, an understanding of the size distribution of a nanomaterial is essential and the number size distribution is the most relevant consideration.

To define an enforceable definition of “nanomaterial” for regulatory use, the opinion proposes to set an upper limit for nanomaterial size and to add to the proposed limit additional guidance specific for the intended regulation. According to the opinion, it is critical that the guidance includes an extended description of relevant criteria to characterize the nanoscale. Merely defining single upper and lower cut-off limits is not sufficient in view of the size distributions occurring in manufactured nanomaterials. Alternatively, a tiered approach may be required depending on the amount of information known for any specifically manufactured nanomaterial and its proposed use.

 

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On December 15, 2010, the U.S. Environmental Protection Agency (EPA) announced that it fined Kinetic Solutions Inc., doing business as Rabbit Air, $82,400 for allegedly selling unregistered and misbranded pesticides and making unproven claims about their effectiveness. According to EPA, Kinetic Solutions Inc. made illegal public health claims for its air purifier branded “Nano Silver Pre Filter” and the filter’s ability to control over 650 types of bacteria, a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In addition, its air purifiers did not list a valid EPA Establishment Number on the packaging, a federal requirement that helps regulators keep track of where pesticides and devices are produced. EPA states that the violations were discovered through an online search and subsequent inspection by the California Department of Pesticide Regulation (CDPR). According to Kinetic Solutions Inc., the Nano Silver Pre Filter incorporates a substance called “nano silver” or “silver nano ions,” a substance or mixture of substances intended to prevent, destroy, repel, or mitigate bacteria and mold. Products that kill or repel bacteria or germs are considered pesticides, and must be registered with the EPA prior to distribution or sale. According to EPA, the Nano Silver Pre Filter is a pesticide and was not registered as such as required by federal law.

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Bergeson & Campbell, P.C. (B&C) is pleased to announce that it attended the first day of the “Nanotechnology Innovation Summit,” which celebrated the tenth anniversary of the National Nanotechnology Initiative (NNI), to meet with many of our clients who showcased their products. The Summit was held December 8-10, 2010, at the Gaylord National Convention Center outside Washington, D.C. The Summit provided attendees an opportunity to meet with key federal government leaders and directors of many NNI agencies, as well as leaders and innovators from industry and academia.

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