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

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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The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) posted its Fiscal Year 2011 Annual Plan, which identifies mandated and selected assignment topics continuing from fiscal year (FY) 2010 and scheduled to be started during FY 2011. According to the Annual Plan, carryover assignments from FY 2010 include EPA’s approach to nanomaterials. The Annual Plan includes no additional information regarding the assignment, which is not included in its FY 2010 Annual Plan.

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The U.S. Environmental Protection Agency (EPA) announced in a December 13, 2010, Federal Register notice that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials. Registration is required to attend the meeting, and EPA states that space is limited. Comments may be submitted in writing or made orally during the meeting. Written comments are due December 28, 2010. EPA intends to consider all such comments in evaluating whether or how to develop further case studies and workshops on nanomaterials. To date, EPA has published two Nanomaterial Case Studies -- Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen (Final), and Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray (External Review Draft).

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The White House Office of Science and Technology Policy (OSTP) and the Nanoscale Science, Engineering, and Technology Subcommittee of the National Science and Technology Council request comments regarding the draft National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy (Strategy). The draft Strategy describes the National Nanotechnology Initiative’s (NNI) environmental, health, and safety (EHS) vision and mission, the state of the science, and the research needed to achieve the vision.  It represents the consensus of the participating agencies on how to promote the responsible development of nanotechnology by providing guidance to federal agencies as they develop their agency-specific research priorities, strategies, and implementation plans to achieve this vision.  It describes the goals and research needs for five science topics that shape EHS research (nanomaterial measurement infrastructure, human exposure assessment, human health, environment, and risk assessment and risk management methods) and evaluates the state of the science for each of these topics.  The draft Strategy also includes an analysis of the fiscal year 2009 federal EHS research portfolio and identifies concepts and approaches to accelerate the pace of research in this crucial area.  The 2011 plan will update and replace the 2008 NNI EHS Research Strategy. Comments are due January 6, 2011.

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On December 3, 2010, the Organization for Economic Cooperation and Development (OECD) posted two documents in its series on the safety of manufactured nanomaterials: 

• Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories -- OECD developed this document as part of its work on occupational exposure mitigation. The document compares existing published guidelines regarding the use of nanomaterials at the laboratory scale, including the manufacture and the use of products in industrial, institutional, and commercial settings. OECD states: “Since there are not globally standardized protection measures determined for nanomaterials, it is expected that this document is to be of interest for research laboratories and industrial enterprises that produce or process nanomaterials at the laboratory scale.”
 
• List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision -- OECD first published this document in 2008. It provides the list of representative manufactured nanomaterials and the list of endpoints for human health and environmental safety addressed by the Sponsorship Programme for the Testing of Manufactured Nanomaterials. OECD states that, based on the current state of knowledge, the Working Party on Manufactured Nanomaterials updated the list of manufactured nanomaterials by removing carbon black and polystyrene, and adding gold-nanoparticles.

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On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The EP passed by a vote of 640 to 3, with 12 abstentions, legislation that would extend the Directive to most EEE, unless specifically excluded. The legislation calls for a review of the Directive after three years, at which time new substances may be added. Exemptions for banned substances would be allowed only if they are in the interest of consumer health and safety and no alternatives are available. Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the European Union (EU) Council and are not included in the version of the legislation passed by both the EU Council and EP. The EP press release notes that “nanomaterials are cited as due for further scientific scrutiny” when RoHS is reviewed in three years.

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The National Institute for Occupational Safety and Health (NIOSH) released a draft Current Intelligence Bulletin (CIB) entitled Occupational Exposure to Carbon Nanotubes and Nanofibers, which recommends that, until results from research studies can fully elucidate the physicochemical properties of carbon nanotubes (CNT) and carbon nanofibers (CNF) that define their inhalation toxicity, employers should take steps to minimize CNT and CNF exposures of all workers and implement an occupational health surveillance program that includes elements of hazard and medical surveillance.  The draft CIB includes more specific recommendations for employers and workers to minimize potential health risks associated with exposure to CNTs and CNFs. NIOSH will hold a public meeting on the draft CIB on February 3, 2011, in Cincinnati, Ohio. According to NIOSH, during the meeting, it will place special emphasis on:

• Whether the hazard identification, risk estimation, and discussion of health effects for CNTs and CNFs are a reasonable reflection of the current understanding of the evidence in the scientific literature;
• Workplaces and occupations where exposure to CNTs and CNFs occur;
• Current strategies for controlling occupational exposure to CNTs and CNFs (e.g., engineering controls, work practices, personal protective equipment);
• Current exposure measurement methods and challenges in measuring workplace exposures to CNTs and CNFs; and
• Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies).

Notification of intent to intend the meeting is due to NIOSH on January 28, 2011. Comments on the draft CIB are due February 18, 2011.

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NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such “hot” topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency’s (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on the commercialization of nanoscale materials; and the EPA’s Office of Pesticide Programs development of a policy under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that will apply to nanopesticides. The NanoBusiness Alliance is an industry association founded to advance the emerging business of nanotechnology and microsystems for corporations, start-ups, researchers, universities, investors, and a host of other key stakeholders.  The Alliance’s mission is to create a collective voice for the emerging small-tech industry and develop a range of initiatives to support and strengthen the nanotechnology business community, through public policy efforts, events, research, and the creation of partnerships.

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On November 18, 2010, the International Center for Technology Assessment (ICTA) petitioned the U.S. Environmental Protection Agency (EPA) to investigate nano-copper pesticides. ICTA, which petitioned EPA in May 2008 to regulate nano-silver and other nano-pesticide products, singles out three registrations obtained by Osmose, Inc. for “micronized” copper carbonate. According to ICTA, “it does not appear that Osmose advised EPA when it applied for these three registrations that any of these products included intentionally produced nanoscale material, but, as explained below, it clearly knew this was the case.” The Office of Pesticide Programs (OPP) has stated that it intends to treat any pesticide products containing nanoscale materials as new products, and ICTA notes that “registrants were also on notice well before 2008 that OPP wanted any applicant requesting registration of a pesticide product containing a nanoscale active ingredient or inert ingredient to disclose that fact during the application process.” ICTA claims that Osmose used the formulator’s exemption to register its products, although it intentionally modified the structure of the purchased active ingredient to create nanoscale particles, which it neglected to tell EPA. ICTA requests that EPA “immediately investigate” the three products, and revoke the registrations, if EPA determines that Osmose registered the products on the basis of an invalid claim. ICTA also requests that EPA “thoroughly investigate other possible nanoscale copper products, which should include but not be limited to copper-based wood treatment products currently available on the market, as similar actions under FIFRA may be necessary.”

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