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

In an October 28, 2011, Federal Register notice, the National Cancer Institute’s (NCI) Alliance for Nanotechnology in Cancer announced the initiation of “Translation of Nanotechnology in Cancer” (TONIC), a public private industry partnership intended to promote translational research and development opportunities of nanotechnology-based cancer solutions. The notice states that an immediate consequence of this effort is the formation of a consortium involving government and pharmaceutical and biotechnology companies. The consortium will evaluate “promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients.” According to the notice, membership in the TONIC consortium will be limited to companies that: (1) have a successful track record of translating diagnostics and drug formulations and reaching their regulatory approval; and (2) are engaged in the development of nanotechnology-based formulations with application to imaging, diagnostics, and therapy.

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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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On October 10, 2011, ACS Nano accepted an article entitled “Generation of Metal Nanoparticles from Silver and Copper Objects:  Nanoparticle Dynamics on Surfaces and Potential Sources of Nanoparticles in the Environment,” in which the authors monitor nanoparticles and their transformations under a variety of environmental conditions.  According to the authors, their studies reveal “unprecedented dynamic behavior” of silver nanoparticles on surfaces.  The authors hypothesize that nanoparticle production occurs through a process involving three stages:  (1) oxidation and dissolution of silver from the surface of the particle; (2) diffusion of silver ion across the surface in an adsorbed water layer; and (3) formation of new, smaller particles by chemical and/or photoreduction.  The authors investigated non-nanoscale sources of silver, including wire, jewelry, and eating utensils placed in contact with surfaces, and found that they also formed new nanoparticles.  According to the authors, copper objects display similar reactivity, suggesting that the phenomenon may be more general.  The authors conclude that “discovery that [silver nanoparticles and copper nanoparticles] are generated spontaneously from manmade objects implies that humans have long been in direct contact with these nanomaterials and that macroscale objects represent a potential source of incidental nanoparticles in the environment.”

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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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